-----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, A4tVp+lCInF4+zxNPa/a6Le9jRJSERKr9yjhFoq6/QFp3UjqgwAhCfZAbQlxVV0G Hox5R0aSxVSBhet1iibMZA== 0000897101-09-000381.txt : 20090227 0000897101-09-000381.hdr.sgml : 20090227 20090227160744 ACCESSION NUMBER: 0000897101-09-000381 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20090103 FILED AS OF DATE: 20090227 DATE AS OF CHANGE: 20090227 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: 09643005 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 stjude090797_10k.htm FORM 10-K FOR THE FISCAL YEAR ENDED JANUARY 3, 2009 ST. JUDE MEDICAL, INC. FORM 10-K FOR THE FISCAL YEAR ENDED JANUARY 3, 2009

Table of Contents

 
 

 

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 January 3, 2009

 

Commission File Number 0-8672

 


 

ST. JUDE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 


 

 

 

Minnesota

 

41-1276891

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation or organization)

 

 

 

 

 

One St. Jude Medical Drive

 

(651) 483-2000

St. Paul, Minnesota 55117

 

(Registrant’s telephone number,

(Address of principal executive

 

including area code)

offices, including zip code)

 

 


Securities registered pursuant to Section 12(b) of the Act:

 

Common Stock ($.10 par value)

 

New York Stock Exchange

(Title of class)

 

(Name of exchange on which registered)

 

 

 

Securities registered pursuant to Section 12(g) of the Act: None


Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes x         No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes o        No x

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 o

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

Large accelerated filer x

Accelerated filer o

 

 

Non-accelerated filer o      (Do not check if a smaller reporting company)

Smaller reporting company o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes o        No x

The aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant was $13.7 billion at June 27, 2008 (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 $40.54 per share.

The registrant had 346,153,801 shares of its $0.10 par value Common Stock outstanding as of February 18, 2009.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Company’s Annual Report to Shareholders for the fiscal year ended January 3, 2009, are incorporated by reference into Parts I and II. Portions of the Company’s Proxy Statement for its 2009 Annual Meeting of Shareholders are incorporated by reference into Part III.


 
 

TABLE OF CONTENTS

 

 

 

 

 

ITEM

 

DESCRIPTION

 

PAGE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PART I

 

 

 

 

 

 

 

1.

 

Business

 

1

1A.

 

Risk Factors

 

14

1B.

 

Unresolved Staff Comments

 

21

2.

 

Properties

 

21

3.

 

Legal Proceedings

 

21

4.

 

Submission of Matters to a Vote of Security Holders

 

22

 

 

 

 

 

 

 

PART II

 

 

 

 

 

 

 

5.

 

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

22

6.

 

Selected Financial Data

 

22

7.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

22

7A.

 

Quantitative and Qualitative Disclosures About Market Risk

 

22

8.

 

Financial Statements and Supplementary Data

 

22

9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

22

9A.

 

Controls and Procedures

 

22

9B.

 

Other Information

 

23

 

 

 

 

 

 

 

PART III

 

 

 

 

 

 

 

10.

 

Directors, Executive Officers and Corporate Governance

 

23

11.

 

Executive Compensation

 

23

12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

23

13.

 

Certain Relationships and Related Transactions, and Director Independence

 

23

14.

 

Principal Accountant Fees and Services

 

23

 

 

 

 

 

 

 

PART IV

 

 

 

 

 

 

 

15.

 

Exhibits and Financial Statement Schedules

 

24

 

 

 

 

 

 

 

Signatures

 

30



Table of Contents

PART I

Item 1. BUSINESS

General
St. Jude Medical, Inc. develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management, cardiology and cardiac surgery and atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain. Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (Neuro). Our CV operating segment focuses on both the cardiology and cardiac surgery therapy areas. Our principal products in each operating segment are as follows: CRM –tachycardia implantable cardioverter defibrillator systems (ICDs) and bradycardia pacemaker systems (pacemakers); CV – vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF – electrophysiology (EP) introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and Neuro – neurostimulation devices. References to “St. Jude Medical,” “St. Jude,” “the Company,” “we,” “us,” and “our” are to St. Jude Medical, Inc. and its subsidiaries.

We market and sell our products through both a direct sales force and independent distributors. The principal geographic markets for our products are the United States, Europe, Japan and Asia Pacific. St. Jude Medical was incorporated in Minnesota in 1976.

We aggregate our four operating segments into two reportable segments based primarily upon their similar operational and economic characteristics: CRM/Neuro and CV/AF. Our performance by reportable segment is included in Note 13 of the Consolidated Financial Statements in the Financial Report included in our 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K.

We utilize a 52/53-week fiscal year ending on the Saturday nearest December 31st. Fiscal year 2008 consisted of 53 weeks and ended on January 3, 2009, and fiscal years 2007 and 2006 consisted of 52 weeks and ended on December 29, 2007 and December 30, 2006, respectively. The additional week in fiscal year 2008 has been reflected in our fourth quarter results.

The table below shows net sales and percentage of total net sales contributed by each of our four operating segments for the fiscal years 2008, 2007, and 2006:

 

 

 

 

 

 

 

 

 

 

 

Net Sales (in thousands)

 

2008

 

2007

 

2006

 

Cardiac Rhythm Management

 

$

2,701,463

 

$

2,368,081

 

$

2,055,765

 

Cardiovascular

 

 

862,136

 

 

790,630

 

 

741,612

 

Atrial Fibrillation

 

 

545,512

 

 

410,672

 

 

325,707

 

Neuromodulation

 

 

254,140

 

 

209,894

 

 

179,363

 

 

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 


 

 

 

 

 

 

 

 

 

 

 

Percentage of Total Net Sales

 

2008

 

2007

 

2006

 

Cardiac Rhythm Management

 

 

61.9

%

 

62.7

%

 

62.2

%

Cardiovascular

 

 

19.8

%

 

20.9

%

 

22.5

%

Atrial Fibrillation

 

 

12.5

%

 

10.9

%

 

9.9

%

Neuromodulation

 

 

5.8

%

 

5.5

%

 

5.4

%

Principal Products
Cardiac Rhythm Management: Cardiac Rhythm Management focuses on the research, development and manufacture of products for cardiac arrhythmias, or irregular heart beats. In 2008, we introduced multiple new products, including: ICDs to provide life-saving therapy to patients suffering from lethal heart conditions such as sudden cardiac arrest; cardiac resynchronization therapy (CRT) devices to save and improve the lives of heart failure (HF) patients; pacemakers to help people whose hearts beat too slowly or who suffer from other cardiac arrhythmias; and leads, which connect our devices to the heart and carry the electrical impulses to the heart and information from the heart back to the device. CRM also develops and markets programmers and remote monitoring equipment that are used by physicians and healthcare professionals to program and analyze data from our devices for the management of their patients.

Our ICDs and cardiac resynchronization therapy-defibrillator (CRT-D) devices treat patients with hearts that beat inappropriately fast, a condition known as tachycardia. ICDs monitor the heartbeat and deliver high 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. ICDs are typically implanted pectorally, below the collarbone, connected to the heart by leads.

1


Table of Contents

In November 2008, we received European CE Mark approval of our AnalyST™ VR/DR ICDs. These devices are capable of continuously monitoring the electrical charges between heart beats (called “ST segments”), providing physicians insight into clinical events to help improve patient management. In addition, our ICD product portfolio includes the Current™ RF (radio frequency) VR/DR, which the U.S. Food and Drug Administration (FDA) approved in November 2007. These devices are available in both standard and high energy versions and feature wireless telemetry. Other ICD offerings include the Epic® II+ DR (FDA approved in March 2006) and high energy Atlas® II+ DR and Atlas® II VR/DR ICDs (FDA approved in July 2006) that offer our vibratory patient alert feature designed for greater patient safety and enhanced telemetry speeds to facilitate faster patient follow-ups. We continue to offer our Epic®+ VR/DR ICDs which received FDA approval and European CE Mark in April 2003, and our Atlas®+ VR/DR ICDs which received FDA approval and European CE Mark in October 2003. The Epic®+ICD family devices are the Company’s smallest line of ICDs and 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 AnalyST™, Current™ RF DR, Epic® II+ DR, Epic®+ DR, Atlas® II +DR and the Atlas®+ DR contain St. Jude Medical’s AF Suppression™ algorithm, which is clinically proven to reduce atrial fibrillation burden.

The Promote™ RF family of devices was approved by the FDA in November 2007. These CRT-D devices are available in both standard and high energy versions, and feature wireless telemetry and include many of the same advanced features of the Current™ RF. Other CRT-D product offerings include the Epic® II HF (FDA approved in March 2006) and high energy Atlas® II HF CRT-Ds (FDA approved in July 2006), which both contain the same unique patient vibratory alert and enhanced telemetry technology found in our Atlas® II VR/DR family of ICDs.

In 2008, we also received approval in Japan for our first CRT product offerings which include the Atlas®+ HF, a high output CRT-D with 36 joules delivered and 42 joules stored; the Epic® HF, with 30 joules delivered; and the QuickSite® left-ventricular (LV) lead.

St. Jude Medical’s QuickOpt™ Timing Cycle Optimization technology was FDA approved in July 2006 and provides for automatic optimized ventricle to ventricle (V-V) and atria to ventricle (A-V) timing in all St. Jude Medical CRT-Ds and dual-chamber ICDs.

Our ICDs are used with the single and dual-shock electrode transvenous defibrillation leads. Our latest ICD lead offering is the Durata™ high voltage lead (FDA approved in January 2008), which features a soft silicone tip and curved right-ventricular (RV) coil designed to further improve implant performance. The Durata™ leads, along with the Riata® ST Optim™ leads (FDA approved in July 2006), are small-diameter ICD leads and feature our exclusive Optim™ insulation material that combines the durability of polyurethane and the softness of silicone. Optim™ insulation material was designed specifically for high and low voltage cardiac pacing leads. The Riata® leads are an advanced family of small-diameter, steroid-eluting, active or passive fixation defibrillation leads. The Riata® integrated bipolar single and dual-shock leads were FDA approved and launched in April 2004 and received European CE Mark in May 2004.

Our QuickSite® Bipolar Model 1056T LV lead was launched in Europe in December 2004 and in the United States in mid-2005. In December 2007, we released the QuickFlex™ family of LV leads in the United States and Europe.

Our pacemakers treat patients with hearts that beat too slowly, a condition known as bradycardia. Similar to ICDs, pacemakers are typically implanted pectorally, monitor the heart’s rate and, when necessary, deliver low-voltage electrical impulses that stimulate an appropriate heartbeat. Single-chamber pacemakers sense and stimulate only one chamber of the heart (atrium or ventricle), while dual-chamber devices can sense and pace in both the upper atrium and lower ventricle chambers. Bi-ventricular pacemakers can sense and pace in three chambers (atrium and both ventricle chambers).

Our current pacing products include the Zephyr™ family of pacemakers, Victory® product line as well as Team ADx® pacemakers, a group comprised of the Identity® ADx, Integrity® ADx and Verity™ ADx families of devices.

The Zephyr™ family of pacemakers (FDA approved in May 2007) includes automaticity features to simplify device follow-up. All standard follow-up tests may be done automatically by the device. The Zephyr™ family of pacemakers includes functionality to reduce unnecessary ventricular pacing.

The Victory® line was approved by the FDA in December 2005. The Victory® and Victory® XL family models provide the enhancements of previous St. Jude Medical families, while adding new capabilities such as automatic P-wave and R-wave measurements with trends, lead monitoring and automatic polarity switch, follow-up electrograms, Ventricular Intrinsic Preference (VIPTM) to reduce right ventricle pacing and a ventricular rate during automatic mode switch histogram.

2


Table of Contents

The Identity® DR and Identity® XL DR devices were approved by the FDA in November 2001, with the rest of the Team ADx™ devices receiving FDA approval in May 2003. The Team ADx devices received European CE Mark in August 2003. The Identity® ADx family models maintain the therapeutic features of previous St. Jude Medical pacemakers, including the AF Suppression™ algorithm and the Beat-by-Beat™ AutoCapture™ Pacing System. This family offers atrial tachycardia and atrial fibrillation arrhythmia diagnostics. These features are designed to help physicians better manage pacemaker patients suffering from atrial fibrillation – the world’s most common cardiac arrhythmia. We also offer the Microny® II SR+ and Microny® K. These small-sized pacemakers are available worldwide. Another pacemaker, the Regency®, is offered outside of the United States.

All of our available pacemaker families 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), delivers a back-up pulse in the event of noncapture, continuously measures threshold (the amount of voltage necessary to stimulate the heart muscle), and makes adjustments in energy output to match changing patient needs. In addition, the Identity® ADx, Integrity® ADx and Identity® pacemakers include St. Jude Medical’s AF Suppression™ Algorithm.

We also market low-voltage device-based ventricular resynchronization systems (bi-ventricular) designed for the treatment of heart failure and suppression of atrial fibrillation. Within the United States, our Frontier II™ CRT-P (cardiac resynchronization therapy-pacing) (FDA approved in August 2004 and CE Mark approved in September 2004) is a bi-ventricular pacing device indicated for use in patients with chronic atrial fibrillation who have been treated with atrioventricular nodal ablation. For placement of these leads, we provide the following delivery systems and accessories: the CPS Direct™, CPS Aim™, CPS Luminary™, CPS Duo™, CPS Courier™ guidewires, and the CPS Venture™ wire control catheter.

Our current pacing leads include the Optisense™ Optim, Optisense™, Tendril® ST Optim, Tendril ST, and Tendril® SDX (models 1688, 1488, 1788 and 1782) lead families and the IsoFlex® Optim, IsoFlex® S, IsoFlex P and Passive Plus® DX passive-fixation lead families, all available worldwide. All of these lead families feature steroid elution, which helps suppress the body’s inflammatory response to a foreign object. Our Optisense™ leads offer an electrode spacing technology that has been clinically proven to significantly reduce far-field over sensing and inappropriate mode switching.

Our CRM devices 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 implant 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 based on patient need, to download stored diagnostic information from the implanted device for physicians to verify appropriate therapeutic settings. Since the introduction of programmable pacemakers, all pacemaker manufacturers, including St. Jude Medical, have retained title to their programmers which are used by their field sales force or by physicians and nurses or technicians.

In April 2006, we received FDA approval for the first software module of our Merlin™ Patient Care System, a universal programmer for St. Jude Medical ICDs and pacemakers. This completely redesigned programmer has a larger display, built-in full-size printer, touch screen and advanced new user interface. The programmer is a result of detailed customer research activities to optimize ease of use and to set new standards for efficient and effective in-clinic follow-up. This programmer has had several software updates since release to extend capabilities and support new products and markets. In 2008, the programmer was updated to include Japanese and Mandarin Chinese language support.

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

In addition to the programmer, physicians can monitor implanted devices and patient status using the Merlin.netTM Patient Care Network. The latest version of this system (v3.0) was launched in the United States in December 2007. This system allows patients to use their home transmitters to send data stored in devices to an internet site for retrieval by their physician through standard analog or DSL telephone lines. Physicians can better manage their increased number of ICD patients by conducting remote follow-up sessions and using alerts of clinically important events, thereby increasing efficiency and reducing risks for the patient. Additionally, patient flexibility is enhanced by the reduction in the number of office visits required and the ability to quickly have a physician interrogate device data whenever symptoms warrant.

3


Table of Contents

In 2008, we launched the Merlin@home line of RF transmitters (FDA approved in July 2008 and European CE Mark approved in September 2008). The RF technology enables daily monitoring and scheduled remote follow-ups to occur in the patient’s home without any required activity by the patient once the unit has been installed.

Cardiovascular: Our Cardiovascular Division focuses on both the cardiology and cardiac surgery therapy areas. We offer both mechanical and tissue replacement heart valves as well as heart valve repair products. Additionally, we offer specialized disposable interventional devices, including vascular closure devices, percutaneous catheter introducers, diagnostic guidewires and temporary bipolar pacing catheters. During 2008, we expanded our product offering through the acquisition of Radi Medical Systems AB (Radi Medical Systems). This acquisition expands our reach into two segments of the cardiovascular market in which we previously had not participated: 1) physiological assessment of coronary artery lesions using intravascular pressure during a cardiovascular procedure, which provides physicians additional diagnostic information to better treat their patients, and 2) assisted manual compression devices for vascular closure, which helps arrest bleeding of the radial and femoral arteries following an intravascular device procedure.

Heart valve replacement or repair may be necessary because the native heart valve has deteriorated due to congenital defects or disease. Heart valves facilitate blood flow from the chambers of the heart throughout the entire body. St. Jude Medical® mechanical heart valves have been implanted in over 1.8 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. We market both the Epic™ and Biocor® stented tissue heart valves. The Epic™ stented tissue valve is identical in design to the Biocor® stented tissue valve but also incorporates an anti-calcification treatment, designed to protect against tissue mineralization, or hardening. In 2007, we initiated the Trifecta™ stented tissue heart valve United States Investigational Device Exemption (IDE) clinical trial.

Annuloplasty rings are prosthetic devices used to repair diseased or damaged mitral heart valves. We offer a line of heart valve repair products, including the semi-rigid SJM® Séguin annuloplasty ring, the fully flexible SJM Tailor® annuloplasty ring and a St. Jude Medical® rigid saddle-shaped annuloplasty ring.

Our vascular closure devices are used to close radial and femoral artery puncture sites following percutaneous coronary interventions, diagnostic procedures and certain peripheral procedures. Active or passive (manual) compression is utilized to assist in closing artery puncture sites. Our active closure devices include our Angio-Seal™ product offering. In 2008, we launched the Angio-SealTM Evolution vascular closure system in the U.S. and most international geographies. In addition to the performance and ease of use benefits offered from prior versions of Angio-SealTM, Angio-SealTM Evolution features automated collagen compaction – thus making it easier for the clinician to ensure immediate arterial hemostasis and rapid deployment of the device. Prior versions of Angio-Seal™, Angio-SealTM VIP and Angio-SealTM STS Plus, continue to generate revenue in our active closure product offering.

We estimate that manual compression is utilized in approximately two-thirds of all vascular closure cases. As a result of our Radi Medical Systems acquisition, we now have passive closure product offerings, expanding our market presence and addressing the vascular closure preferences of all physicians. Our passive closure offerings include both the RadiStop® and FemoStop® manual compression systems that arrest bleeding of the radial and femoral arteries, respectively. External compression devices are often used to maintain pressure on the arteriotomy in order to facilitate hemostasis.

In coronary disease diagnosis and intervention, an emerging treatment model involves the use of tools for physiologic lesion assessment rather than sole reliance on contrast-enhanced angiography. In this treatment model, blood flow through a stenotic coronary lesion is measured with a special purpose coronary guidewire containing a pressure sensor. As a result of our Radi Medical Systems acquisition, we now market PressureWire® Certus, which provides precise measurements of intravascular pressure during a cardiovascular procedure and helps aid physicians in determining the most beneficial lesions to treat. At the October 2008 Transcatheter Cardiovascular Therapeutics conference, results from the pivotal Fractional flow reserve versus Angiography in Multivessel Evaluation (FAME) study were presented which demonstrated significant reductions in mortality, morbidity, stent utilization and procedural cost when PressureWire® Certus was employed to guide the physician decision-making process. The results of the FAME study were published in the New England Journal of Medicine in January 2009. PressureWire® Certus has regulatory approval in Europe and Japan as well as FDA approval in the United States.

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. Our percutaneous catheter introducer portfolio consists 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. Diagnostic guidewires, such as the GuideRight™ and HydroSteer™ guidewires, are used in conjunction with percutaneous catheter introducers to aid in the introduction of intravascular catheters. Our diagnostic guidewires are available in multiple lengths and incorporate a surface finish for lasting lubricity.

4


Table of Contents

Our 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. We produce and market several designs of bipolar temporary pacing catheters, including our Pacel™ pacing catheters, which are available in both torque control and flow-directed models with a broad range of curve choices and electrode spacing options.

Atrial Fibrillation: Atrial fibrillation is a rapid and inconsistent heart rhythm that occurs in the upper chambers of the heart. People suffering from atrial fibrillation may experience fatigue and shortness of breath, and atrial fibrillation has been shown to increase the risk of stroke. Atrial fibrillation and other irregular heart rhythms such as atrial flutter and Wolff-Parkinson-White Syndrome are often managed with medications that palliate the symptoms of the irregular heartbeat. We are committed to developing device-based ablation therapies for these conditions that offer the potential for a cure.

We provide a complete system of products – for access, diagnosis, visualization and ablation - - that assist physicians in diagnosing and treating various irregular heart rhythms. Our products are designed to be used in the electrophysiology (EP) lab and cardiac surgery.

Our access products enable clinicians to facilitate the percutaneous delivery of diagnostic and ablation catheters to areas of the heart where arrhythmias occur. These products include, among others, our Swartz™ and Swartz™ Braided Transseptal fixed-curve introducers, which are designed to guide catheters to precise locations in the left atrium. In addition, our Agilis™ NxT Steerable Introducer (FDA approved in July 2006) enables flexible mobility and stability of catheters in the heart while reducing the outside diameter of the introducer.

For diagnosing arrhythmias percutaneously, we offer a portfolio of fixed-curve and steerable catheters. Our Response™ and Supreme™ fixed curve catheters gather electrical information from the heart that indicates what may be causing an arrhythmia. Our steerable product lines include Livewire™ and Reflexion™, which allow clinicians to move the catheter tip in precise movements in order to diagnose the more anatomically challenging areas within the heart. Our Reflexion™ Spiral (FDA approved in October 2006) and Inquiry™ Optima™ PLUS (FDA approved in March 2006) are circular mapping catheters that enable the physician to check for electrical isolation of the pulmonary vein openings during an AF ablation procedure. In addition, our EnSite Array™ Non-contact Mapping Catheter works with the EnSite® System, enabling physicians to record electrical activity for a number of arrhythmias and is especially well suited to quickly map complex and unstable arrhythmias in a single heartbeat without touching the walls of the patient’s heart.

In 2008, we also entered the market for implantable cardiac monitors with the release of our Confirm™ device (FDA approved and CE Mark approved in September 2008). This small implantable device is designed to help physicians monitor for abnormal cardiac conditions.

In July 2008, we acquired EP MedSystems, Inc. (EP MedSystems), broadening our portfolio of diagnostic products with the addition of the EP–WorkMate® recording system and the ViewFlex® range of ultrasound products. The EP–WorkMate® recording system is used to monitor electrical activity of the heart via intracardiac catheters and features our new ClearWave technology for high fidelity signals and an integrated stimulator. The ultrasound product line consists of the ViewMate® II ultrasound console and the ViewFlex® PLUS ultrasound catheter. This ultrasound system provides intracardiac ultrasound imaging to help provide more detail about the cardiac anatomy and guide therapy delivery.

Our EnSite® System is a mapping and navigation system that, when used in conjunction with the EnSite® Array™ non-contact mapping catheter or EnSite NavX™ navigation and visualization technology, creates three-dimensional (3D) cardiac models, shows catheters moving within those models, and allows physicians to map and visualize electrical activity in the heart. In 2008, we launched the EnSite® System Version 8.0 software platform, which enables the creation of cardiac models with a higher level of detail while also providing improved reproducibility as well as several new approaches to visually present arrhythmia patterns. In 2007, we launched the EnSite Fusion™ Registration Module, a software expansion module for our EnSite® System that registers the EnSite NavX™ 3D model to a segmented computed tomography (CT) image of cardiac anatomy, allowing for additional detailed levels of cardiac anatomy to be visualized and navigated within one image during an ablation procedure.

We offer two general ablation product lines which focus on disabling abnormal tissue that causes or perpetuates arrhythmias: ablation catheters, which are used as part of a percutaneous procedure and are designed to apply RF energy to the inside of the heart; and surgical cardiac ablation devices, which are used to ablate cardiac tissue from the epicardium (outside the heart).

5


Table of Contents

Our Livewire™ TC Ablation Catheters include uni- and bi-directional models that offer stability and excellent tissue contact with cardiac tissue. Our Safire™ Bi-directional Ablation Catheter product line offers a comprehensive range of catheter tip sizes (4mm and 5mm, FDA approved in August 2006; and 8mm, FDA approved in October 2007) and curve configurations and is built on our ComfortGrip™ handle platform that is designed for physician comfort and control during EP procedures. Our Therapy™ 4 and 8 mm tip standard catheter lines provide a range of curve options and temperature control. When used with our IBI-1500 series Cardiac Ablation Generators, power can be effectively managed for the creation of longer ablation lines. In addition to the standard (non-irrigated) tip ablation catheters, we also offer the open-irrigated tip Therapy Cool Path™ ablation catheter. The Therapy Cool Path™ catheter features holes at the tip of the catheter that allow infused saline to circulate around the tip during therapy delivery. The ability to infuse saline allows the tip to be cooled and lessens the potential for char or thrombus to form during ablation.

Our surgical cardiac ablation product line, the Epicor™ Cardiac Ablation System (Epicor™ System), creates cardiac ablation lesions by applying high intensity focused ultrasound (HIFU) to the outside of a beating heart without the need to put the patient on a heart-lung bypass machine. The primary components of the Epicor™ System include the Epicor™ Ablation Control System that generates and controls the ultrasound energy, the UltraCinch™ Ablation Device (FDA approved in May 2004) that creates circumferential lesions in cardiac tissue and the UltraWand™ Handheld Ablation Device (FDA approved in February 2004) that allows for additional linear lesions to be created.

Neuromodulation: The neuromodulation market has two main categories of treatment: neurostimulation, in which an implantable device delivers electrical current directly to targeted nerve sites, and implantable drug infusion systems, in which an implanted pump delivers drugs through a catheter directly to targeted nerve sites. The majority of our Neuromodulation product offerings provide neurostimulation treatment.

Neurostimulation for the treatment of chronic pain involves delivering low-level electrical impulses via an implanted device (sometimes referred to as a “pacemaker for pain”) directly to the spinal cord or peripheral nerves. This stimulation interferes with the transmission of pain signals to the brain and inhibits or blocks the sensation of pain felt by the patient. This stimulation of nerves at or near the site where pain is perceived replaces the painful sensations with a sensation called paresthesia, which is often described as a tingling or massaging sensation. Neurostimulation for chronic pain is generally used to manage sharp, intense and constant pain arising from nerve damage or nervous system disorders. A neurostimulation system typically consists of three components: a pulse generator/receiver that produces the electric current directed to the lead(s) and is generally implanted under the patient’s skin; a programmer/transmitter that is used to program the power supply and to adjust the intensity, frequency and duration of the stimulation; and leads that carry the electrical impulses to the targeted nerve sites. Clinical results demonstrate that many patients who are implanted with a neurostimulation system experience a substantial reduction in pain, an increase in activity level, a reduction in use of narcotics and a reduction in hospitalization.

We offer a wide array of neurostimulation systems including rechargeable implantable pulse generators (IPGs), primary cell implantable pulse generators and RF powered systems. We currently market three neurostimulation product platforms worldwide: Eon™ IPG systems, which include rechargeable and primary cell battery models, Genesis® primary cell IPG systems and Renew® RF systems.

The Eon™ rechargeable IPG is a 16-contact IPG with a high capacity battery. It offers a broad range of options to help the clinician maximize success in managing chronic pain. The Eon™ IPG provides enhanced longevity between recharges, allowing patients added flexibility in their recharging schedule. It is FDA approved to operate at least 24 hours between recharges at 10 years at high settings. The device is designed to provide consistent pain therapy.

In 2008, we introduced the Eon Mini rechargeable 16-contact IPG. Its small size offers the potential for alternative placement options, which helps clinicians treat a variety of patients. It is FDA-approved to operate at least 24 hours between recharges for 10 years at high settings – a long battery life for its small size. The Eon Mini IPG is well-suited for patients with smaller body mass and low to high power requirements.

In 2008, we also introduced the EonC primary cell IPG. It features a large-capacity battery and constant current pulse delivery for consistent, low-maintenance therapy. It is well-suited for patients with low to medium power requirements and those who prefer the simplicity of a non-rechargeable IPG.

The Genesis® IPG system offers a high battery capacity-to-size ratio and flexibility in addressing different pain patterns. The GenesisXP™ IPG system offers a greater battery capacity, resulting in enhanced longevity and/or additional power to treat more complex pain. Conventional IPGs, such as Genesis® and GenesisXP™, are well-suited for patients with relatively simple pain or modest power requirements and for patients who would have difficulty managing a rechargeable system or a RF system.

The Renew® RF system features a small implanted RF receiver/pulse generator, leads and a transmitter containing a power source that is worn externally. The system is powered with the help of an antenna that is attached to the patient’s skin with a removable belt or an adhesive pad. As the Renew® system has a rechargeable, external power source, we believe it is best suited for patients with complex, changing or multi-extremity pain patterns that require higher power levels for treatment when battery management, even with a rechargeable system, is problematic.

6


Table of Contents

We currently market Rapid Programmer®, a programming platform designed to allow clinicians to quickly and efficiently test patients intraoperatively and to program postoperatively. The Rapid Programmer® system features two technologies for delivering stimulation to pain patients: Dynamic MultiStim™ and Active Balancing™. Dynamic MultiStim™ technology allows for real-time programming adjustments to multiple areas of pain, which better targets pain coverage and decreases programming time. This is especially useful when patients have complex pain patterns, such as a combination of back and leg pain. Active Balancing™ lets patients and clinicians fine-tune stimulation levels in multiple coverage areas, quickly establishing relief and giving patients sophisticated, yet easy-to-use, control over their therapy. This palm-sized programmer features a touch screen interface, which clinicians can navigate to create multiple programs, adjust variables and generate pain and stimulation maps while decreasing the average postoperative programming time.

We market a broad variety of leads, which are intended to give clinicians the flexibility to meet a range of patient needs. Our leads can be divided into two types: percutaneous and paddle leads. Our percutaneous leads consist of the 8-contact Octrode® and 4-contact Quattrode® lead designs. Our paddle lead offering consists of the Lamitrode® family of leads. This family includes the Lamitrode® 88 lead, which consists of single and dual column paddle leads that provide up to two vertebral segments of coverage; Tripole™ leads, which feature a three-column electrode array that is designed to focus stimulation more precisely for enhanced targeting of low back pain; Lamitrode S-Series™ leads, which feature a small profile that is intended to ease insertion, and an integrated stylet that is engineered to improve steering and control during implantation; and Lamitrode C-Series™ leads, shaped to mimic the curve of the epidural space of the spine and designed to facilitate lead placement and reduce lead migration.

The neurostimulation market continues to develop. Deep brain stimulation (DBS) for motor disorders (e.g. Parkinson’s disease and essential tremor) continue to grow and potential new indications such as DBS for depression, occipital stimulation for migraine, angina, and obesity continue to be investigated. We continue to enroll patients in our pivotal studies in the U.S. for Parkinson’s disease and essential tremor to investigate the safety and efficacy of the Libra® DBS system. We are also continuing enrollment for another pivotal study for chronic migraine. We have conducted a multi-center trial for depression in Canada and in the second quarter of 2008 we began enrollment of patients into the BROADEN™ (BROdmann Area 25 Deep brain Neuromodulation) clinical study. BROADEN™ is a clinical study that is evaluating the safety and effectiveness of DBS therapy in patients with depression for whom currently available treatments are not effective. Other potential indications are in various stages of evaluation, regulatory review and trial. In December 2008, we received European CE Mark approval for the Libra® and LibraXP™ DBS systems for treating the symptoms of Parkinson’s disease, a neurological disorder that progressively diminishes a person’s control over his or her movements and speech. The limited launch of these systems in Europe are our first approved products in the DBS market.

Competition

The medical device market is intensely competitive and characterized by extensive research and development and rapid technological change. In addition, competitors have historically employed litigation to gain a competitive advantage. Our competitors range from small start-up companies to larger companies that have significantly greater resources and broader product offerings, and we anticipate that in the coming years, other large companies will enter certain markets in which we currently hold a strong position. We expect competition will continue to intensify with the increased use of strategies such as consigned inventory and reduced pricing.

Our customers consider many factors when choosing suppliers, including product reliability, clinical outcomes, product availability, inventory consignment, price and product services provided by the manufacturer. As a result, market share can shift due to technological innovation, product field actions and safety alerts as well as from other business factors.

We are one of the three principal manufacturers and suppliers in the global CRM market. Our primary competitors in this market are Medtronic, Inc. (Medtronic) and Boston Scientific Corporation (Boston Scientific). These two competitors are larger than us and have invested substantial amounts in CRM research and development (R&D). These markets are highly competitive and rapid technological change is expected to continue, requiring us to invest heavily in R&D and to effectively market our products.

The cardiovascular market is also highly competitive with numerous competitors. The majority of our sales is generated from our vascular closure devices and heart valve replacement and repair products. We continue to hold the number one market position in the vascular closure device market; however, 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. Our primary vascular closure device competitor is Abbott Laboratories. Additionally, we anticipate other large companies will enter this market in the coming years, which will increase competition. The cardiovascular market also includes cardiac surgery products such as mechanical heart valves, tissue heart valves and valve repair products, which are also highly competitive. We are the world’s leading manufacturer and supplier in the mechanical heart valve market. Our principal competitors in the mechanical heart valve market are Sorin CarboMedics, ATS Medical, Inc. and several smaller manufacturers. In the tissue heart valve market, we compete against two principal tissue heart valve manufacturers – Edwards Lifesciences Corporation (Edwards Lifesciences) and Medtronic – as well as many other smaller manufacturers. Cardiac surgery therapies continue to shift from mechanical heart valves to tissue valves and repair products. Other competitors such as Edwards Lifesciences manufacture transcatheter heart valves that are marketed to patients who may be too frail for traditional heart valve surgery.

7


Table of Contents

The atrial fibrillation therapy area is broadening to include multiple therapy methods and treatments which include drugs, percutaneous delivery of diagnostic and ablation catheters, external electrical cardioversion and defibrillation, implantable defibrillators and open-heart surgery. As a result, we have numerous competitors in the emerging atrial fibrillation market. Larger competitors, such as Medtronic, have started to extend their presence in the atrial fibrillation market through acquisitions or by leveraging their cardiac rhythm management capabilities. Our primary competitors include Biosense Webster, a division of Johnson & Johnson, Inc., C.R. Bard, Inc. and Boston Scientific.

The neuromodulation market is one of medical technology’s fastest growing segments. We are one of three principal manufacturers of neurostimulation devices. Competitive pressures will increase in the future as our primary competitors, Medtronic and Boston Scientific, attempt to secure and grow their positions in the neuromodulation market. Although we also compete against smaller competitors like Cyberonics, Inc., barriers to entry for new competitors are high, due to a long and expensive product development and regulatory approval process as well as the intellectual property and patent positions existing in the market. However, other larger medical device companies may be able to enter the neuromodulation market by leveraging their existing medical device capabilities, thereby decreasing the time and resources required to enter the market.

Patents, Licenses and Trademarks
Our policy is to protect our intellectual property rights related to our medical devices. Where appropriate, we apply for U.S. and foreign patents. We own or hold licenses to numerous U.S. and foreign patents. U.S. patents are typically granted for a term of twenty years from the date a patent application is filed. The actual protection afforded by a foreign patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage and the availability of legal remedies in the country. In those instances where we have acquired technology from third parties, we have sought to obtain rights of ownership to the technology through the acquisition of underlying patents or licenses.

We also have obtained certain trademarks and tradenames for our products to distinguish our products from our competitors’ products. U.S. trademark registrations are for a term of ten years and are renewable every ten years as long as the trademarks are used in the regular course of trade. We register our trademarks in the U.S. and in a number of countries where we do business.

While we believe design, development, regulatory and marketing aspects of the medical device business represent the principal barriers to entry, we also recognize that our patents and license rights may make it more difficult for competitors to market products similar to those we produce. We can give no assurance that any of our 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 our 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 we will be able to prevent competitors from challenging our patents or entering markets we currently serve.

Research and Development
We are 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 our existing products. Our research and development expenses were $531.8 million (12.2% of net sales) in 2008, $476.3 million (12.6% of net sales) in 2007 and $431.1 million (13.1% of net sales) in 2006. Although our research and development expenses have decreased as a percent of net sales in recent years, total research and development expense has increased over 10% in each of the last two years. We also recognized $319.4 million of purchased in-process research and development expense in connection with acquisitions completed in 2008.

Acquisitions
In addition to generating growth internally through our own research and development activities, we also make strategic acquisitions and investments to access new technologies and therapy areas. We expect to continue to make acquisitions and investments in future periods to strengthen our business.

8


Table of Contents

On July 3, 2008, we completed the acquisition of EP MedSystems for $95.7 million (consisting of $59.0 million in net cash consideration and direct acquisition costs and 0.9 million shares of St. Jude Medical common stock). EP MedSystems had been publicly traded on the NASDAQ Capital Market under the ticker symbol EPMD. EP MedSystems is based in West Berlin, New Jersey and develops, manufactures and markets medical devices for the electrophysiology market which are used for visualization, diagnosis and treatment of heart rhythm disorders. We acquired EP MedSystems to strengthen our portfolio of products used to treat heart rhythm disorders. EP MedSystems has become part of our Atrial Fibrillation division.

On December 19, 2008, we completed the acquisition of Radi Medical Systems for $248.9 million in net cash consideration, including direct acquisition costs. Radi Medical Systems is based in Uppsala, Sweden and develops, manufactures and markets products that provide precise measurements of intravascular pressure during a cardiovascular procedure and manual compression systems that arrest bleeding of the femoral and radial arteries following an intravascular medical device procedure. We acquired Radi Medical Systems to accelerate our cardiovascular growth platform in these two segments of the cardiovascular medical device market in which we previously had not participated. Radi Medical Systems has become part of our Cardiovascular division.

On December 22, 2008, we completed the acquisition of MediGuide, Inc. (MediGuide) for $285.2 million in net consideration, which includes future estimated cash payments of approximately $145 million and direct acquisition costs. MediGuide was a development-stage company based in Haifa, Israeli and has been focused on developing its Medical Positioning System (gMPSTM) technology for localization and tracking capability for interventional medical devices. We plan to expend additional research and development efforts to achieve technological feasibility for this technology. MediGuide has become part of our Atrial Fibrillation division.

Marketing and Distribution
Our products are sold in more than 100 countries throughout the world. No distributor organization or single customer accounted for more than 10% of 2008, 2007, or 2006 consolidated net sales.

In the United States, we sell directly to healthcare providers primarily through a direct sales force. In Europe, we have direct sales organizations selling in 23 countries. In Japan, we sell directly to healthcare providers through a direct sales force and we also continue to use longstanding independent distributor relationships. In Asia Pacific, we have direct sales organizations selling in seven countries, and we also utilize independent distributors. Throughout the rest of the world, we use a combination of independent distributors and direct sales forces.

Group purchasing organizations (GPO), independent delivery networks (IDN) and large single accounts such as the Veterans Administration in the United States continue to consolidate purchasing decisions for some of our healthcare provider 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 products to a particular healthcare provider.

International Operations
Our net sales and long-lived assets by significant geographic areas are presented in Note 13 of the Consolidated Financial Statements in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K.

Our international business is subject to special risks such as: foreign currency exchange controls and fluctuations; the imposition of or increase in import or export duties, surtaxes, tariffs or customs duties; the imposition of import or export quotas or other trade restrictions; foreign tax laws and increased costs associated with overlapping tax structures; longer accounts receivable cycles; and other international regulatory, economic, legal and political problems. Such risks are further described in Item 1A, Risk Factors of this Form 10-K. Currency exchange rate fluctuations relative to the U.S. Dollar can affect reported consolidated revenues and net earnings. We hedge a portion of this exposure 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 in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K.

Seasonality
Our quarterly net sales are influenced by many factors, including new product introductions, acquisitions, regulatory approvals, patient and physician holiday schedules and other factors. Net sales in the third quarter are typically lower than other quarters of the year as a result of patient tendencies to defer, if possible, procedures during the summer months and from the seasonality of the U.S. and European markets, where summer vacation schedules normally result in fewer procedures.

9


Table of Contents

Suppliers
We purchase raw materials and other products from numerous suppliers. Our manufacturing requirements comply with the rules and regulations of the FDA and comparable agencies in foreign countries, which mandate validation of materials prior to use in our products. We purchase certain supplies used in our manufacturing processes from single sources due to quality considerations, costs or constraints resulting from regulatory requirements. Agreements with certain suppliers are terminable by either party upon short notice and we have been advised periodically by some suppliers that in an effort to reduce their potential product liability exposure, they may terminate sales of products to customers that manufacture implantable medical devices. While some of these suppliers have modified their positions and have indicated a willingness to continue to provide a product temporarily until an alternative vendor or product can be qualified (or even to reconsider the supply relationship), where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly. A reduction or interruption by a sole-source supplier of the supply of materials or key components used in the manufacturing of our products or an increase in the price of those materials or components could adversely affect our business, financial condition and results of operations.

Government Regulation
Our products, development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), by comparable agencies in foreign countries and by other regulatory agencies and governing bodies. Under the FDCA and associated regulations, manufacturers of medical devices must comply with certain regulations that cover the composition, labeling, testing, clinical study, manufacturing, packaging and distribution of medical devices. Medical devices must receive FDA clearance or approval before they can be commercially marketed in the United States. The most comprehensive level of approval requires the completion of an FDA-approved clinical evaluation program and submission and approval of a pre-market approval (PMA) application before a device may be commercially marketed. Our vascular closure devices, mechanical and tissue heart valves, ICDs, pacemakers and certain leads, neurostimulation devices and EP catheter applications require a PMA application or supplement to a PMA. Other leads and lead delivery tools, annuloplasty ring products, other neurostimulation devices and other EP and cardiology products are currently marketed under the less rigorous 510(k) pre-market notification procedure of the FDCA.

Furthermore, our international business is subject to medical device laws in individual countries outside the United States. Most major markets for medical devices outside the United States require clearance, approval or compliance with certain standards before a product can be commercially marketed. The applicable laws range from extensive device approval requirements in some countries for all or some of our 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. The process of obtaining marketing clearance from the FDA and foreign regulatory agencies for new products or with respect to enhancements or modifications to existing products can take a significant period of time, require the expenditure of substantial resources, involve rigorous pre-clinical and clinical testing, require changes to the products and result in limitations on the indicated uses of the products.

The FDA conducts inspections prior to approval of a PMA application to determine compliance with the quality system regulations that cover manufacturing and design. In addition, the FDA may require testing and surveillance programs to monitor the effects of approved products that have been commercialized, and may prevent or limit further marketing of products based on the results of these post-marketing programs. At any time after approval of a product, the FDA may conduct periodic inspections to determine compliance with both the FDA’s Quality System Regulation (QSR) requirements and/or current medical device reporting regulations. Product approvals by the FDA can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval. The failure to comply with regulatory standards or the discovery of previously unknown problems with a product or manufacturer could result in fines, delays or suspensions of regulatory clearances, seizures or recalls of products (with the attendant expenses), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and criminal prosecution, as well as decreased sales as a result of negative publicity and product liability claims.

We are required to register with the FDA as a device manufacturer and as a result, we are subject to periodic inspection by the FDA for compliance with the FDA’s QSR requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures. In addition, the federal Medical Device Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA. In the European Community, we are required to maintain certain International Organization for Standardization (ISO) certifications in order to sell products, and we undergo periodic inspections by notified bodies to obtain and maintain these certifications.

10


Table of Contents

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 group (DRG) and Ambulatory Patient Classification (APC) reimbursement schedules dictate the amount that the U.S. government, through the Centers for Medicare and Medicaid Services (CMS), will reimburse hospitals for care of persons covered by Medicare. In response to rising Medicare and Medicaid costs, from time to time Congress and state legislatures consider legislation that would restrict funding for these programs. Changes in current DRG and APC reimbursement levels could have an adverse effect on market demand and our domestic pricing flexibility. In the U.S., Medicare payment to providers is based on prospectively set rates. CMS, which administers the Medicare and Medicaid programs, uses separate Prospective Payment Systems for reimbursement to acute inpatient hospitals, hospital outpatient departments and ambulatory surgery centers. In response to rising Medicare costs, from time to time Congress considers proposals that would reduce the annual update in federal payments to hospitals. Reduced funding could have an adverse effect on market demand and our domestic pricing flexibility.

More generally, major third-party payors for hospital services in the United States and abroad continue to work to contain healthcare costs. The introduction of cost containment incentives, combined with closer scrutiny of healthcare expenditures by both private health insurers and employers, has resulted in increased discounts and contractual adjustments to hospital charges for services performed and in the shifting of services between inpatient and outpatient settings. From time to time, initiatives to limit the growth of healthcare costs, including price regulation, are underway in several countries in which we do business. Implementation of healthcare reforms in the United States and in significant overseas markets may limit the price of or the level at which reimbursement is provided for our products.

The United States Medicare-Medicaid Anti-kickback law generally prohibits payments to physicians or other purchasers of medical products under these government programs as an inducement to purchase a product. Many foreign countries have similar laws. We subscribe to the AdvaMed Code (AdvaMed is a U.S. medical device industry trade association) which limits certain marketing and other practices in our relationships with product purchasers. We also adhere to many similar codes in countries outside the United States. In addition, we have in place and are continuously improving our internal business integrity and compliance program.

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, the U.S. Department of Health and Human Services has issued patient privacy standards (HIPAA privacy standards) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The HIPAA privacy standards govern the use and disclosure of protected health information by “covered entities,” which are healthcare providers that submit electronic claims, health plans and healthcare clearinghouses. Our employee health benefit plans are considered ‘covered entities’ and therefore are subject and adhere to the HIPAA privacy standards. Additionally, our Merlin.net Patient Care Network system adheres to the HIPAA privacy standards and the security requirements for the electronic transmission of health information as set forth by HIPAA. Our policy continues to be to work with our customers and business partners in their HIPAA compliance efforts.

Some medical device regulatory agencies have considered and are 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,” a disease which has sometimes been transmitted to humans through the consumption of beef. We are not aware of any reported cases of transmission of BSE through medical products. Some of our products (Angio-Seal™ and vascular grafts) use bovine collagen. In addition, some of the tissue heart valves we market incorporate bovine pericardial material. We are cooperating with the regulatory agencies regarding these issues.

Product Liability
The design, manufacture and marketing of our medical devices entail an inherent risk of product liability claims. Our products are often used in intensive care settings with seriously ill patients, and many of the medical devices we manufacture and sell are designed to be implanted in the human body for long periods of time or indefinitely. There are a number of factors that could result in an unsafe condition or injury to, or death of, a patient with respect to these or other products which we manufacture or sell, including component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information. Product liability claims may be brought by individuals or by groups seeking to represent a class.

We are currently the subject of various product liability claims, including several lawsuits which may be allowed to proceed as class actions in the United States and Canada. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, and the magnitude of the potential loss relating to such lawsuits may remain unknown for substantial periods of time. In addition, product liability claims may be asserted against us in the future, relative to events that are not known to management at the present time.

11


Table of Contents

Insurance
Problems with our products can result in product liability claims or a field action, safety alert or advisory notice relating to the product. Our product liability insurance coverage is designed to help protect us against a catastrophic claim. Our current product liability policies (for the period June 15, 2008 through June 15, 2009) provide $350 million of insurance coverage, with a $50 million per occurrence deductible or a $100 million deductible if the claims are deemed an integrated occurrence under the policies.

Our facilities could be materially damaged by earthquakes, hurricanes and other natural disasters or catastrophic circumstances. California earthquake insurance is currently difficult to obtain, extremely costly, and restrictive with respect to scope of coverage. Our earthquake insurance for our significant CRM facilities located in Sylmar and Sunnyvale, California, provides $10 million of insurance coverage in the aggregate, with a deductible equal to 5% of the total value of the facility and contents involved in the claim. Consequently, despite this insurance coverage, we could incur uninsured losses and liabilities arising from an earthquake near one or both of our California facilities as a result of various factors, including the severity and location of the earthquake, the extent of any damage to our facilities, the impact of an earthquake on our California workforce and on the infrastructure of the surrounding communities and the extent of damage to our inventory and work in process. While we believe that our exposure to significant losses from a California earthquake could be partially mitigated by our ability to manufacture some of our CRM products at our manufacturing facilities in Sweden and Puerto Rico, the losses could have a material adverse effect on our business for an indeterminate period of time before this manufacturing transition is complete and operates without significant disruption. Furthermore, our manufacturing facilities in Puerto Rico may suffer damage as a result of hurricanes which are frequent in the Caribbean and could result in lost production and additional expenses to us to the extent any such damage is not fully covered by our hurricane and business interruption insurance.

Employees
As of January 3, 2009, we had approximately 14,000 employees worldwide. Our employees are not represented by any labor organizations, with the exception of certain employees in Sweden and France. We have never experienced a work stoppage as a result of labor disputes. We believe that our relationship with our employees is generally good.

Executive Officers of the Registrant
The following is a list of our executive officers as of February 18, 2009. For each position, the dates in parentheses indicate the year during which each executive officer began serving in such capacity.

 

 

 

 

 

Name

 

Age

 

Position

 

 

 

 

 

Daniel J. Starks

 

54

 

Chairman (2004), President (2001) and Chief Executive Officer (2004)

 

 

 

 

 

John C. Heinmiller

 

54

 

Executive Vice President (2004) and Chief Financial Officer (1998)

 

 

 

 

 

Joseph H. McCullough

 

59

 

Group President (2008), Interim President, U.S. (2008)

 

 

 

 

 

Michael T. Rousseau

 

53

 

Group President (2008)

 

 

 

 

 

Frank J. Callaghan

 

55

 

President, Cardiovascular (2008)

 

 

 

 

 

Christopher G. Chavez

 

53

 

President, Neuromodulation (2005)

 

 

 

 

 

Eric S. Fain, M.D.

 

48

 

President, Cardiac Rhythm Management (2007)

 

 

 

 

 

Denis M. Gestin

 

45

 

President, International (2008)

 

 

 

 

 

Jane J. Song

 

46

 

President, Atrial Fibrillation (2004)

 

 

 

 

 

I. Paul Bae

 

44

 

Vice President, Human Resources (2006)

 

 

 

 

 

Angela D. Craig

 

37

 

Vice President, Corporate Relations (2006)

 

 

 

 

 

Pamela S. Krop

 

50

 

Vice President (2006), General Counsel (2006) and Secretary (2006)

 

 

 

 

 

Thomas R. Northenscold

 

51

 

Vice President, Information Technology (2008) and Chief Information Officer (2008)

 

 

 

 

 

Donald J. Zurbay

 

41

 

Vice President (2006) and Corporate Controller (2004)

12


Table of Contents

Mr. Starks has served on St. Jude Medical’s Board of Directors since 1996 and has been Chairman, President and Chief Executive Officer of St. Jude Medical since May 2004. Previously, Mr. Starks was President and Chief Operating Officer of St. Jude Medical from February 2001 to May 2004. From April 1998 to February 2001, he was President and Chief Executive Officer of our Cardiac Rhythm Management Division, and prior to that, Mr. Starks was Chief Executive Officer and President of Daig Corporation, a wholly-owned subsidiary of St. Jude Medical. Mr. Starks serves on the Board of Directors of Urologix, Inc., a urology medical device company.

Mr. Heinmiller joined St. Jude Medical in May 1996 as a part of our acquisition of Daig Corporation, where Mr. Heinmiller had served as Vice President of Finance and Administration since 1995. In May 1998, he was named Vice President of Corporate Business Development. In September 1998, he was appointed Vice President, Finance and Chief Financial Officer and in May 2004 was promoted to Executive Vice President.

Mr. McCullough joined St. Jude Medical in 1994 as a Cardiac Rhythm Management Regional Sales Director. He became Director of Cardiac Rhythm Management Marketing in 1996 and was named Vice President of Cardiac Rhythm Management Marketing in January 1997. In December 1997, Mr. McCullough was appointed European Cardiac Rhythm Management Business Unit Director. He became Vice President, Cardiac Rhythm Management Europe and Managing Director of manufacturing operations in Veddesta, Sweden, in January 1999, and Senior Vice President, Cardiac Rhythm Management Europe in August 1999. Mr. McCullough served as President, International Division from July 2001 to January 2008, when he was promoted to Group President, with the Company’s U.S. and International Divisions and Corporate Brand and Global Marketing functions reporting directly to him. In November 2008, Mr. McCullough also began serving as President, U.S. on an interim basis.

Mr. Rousseau joined St. Jude Medical in 1999 as Senior Vice President, Cardiac Rhythm Management Global Marketing. In August 1999, Cardiac Rhythm Management Marketing and Sales were combined under his leadership. In January 2001, he was named President, U.S. Cardiac Rhythm Management Sales, and in July 2001, he was named President, U.S. Division, a position Mr. Rousseau held until January 2008, when he was promoted to Group President, with the Company’s four product divisions reporting directly to him.

Mr. Callaghan joined St. Jude Medical as Vice President of Research and Development for the Atrial Fibrillation Division in January 2005 as part of the ESI acquisition. From 1995 to 2005, Mr. Callaghan served as Vice President of Research and Development for ESI. In January 2008, he was promoted to President, Cardiovascular Division.

Mr. Chavez serves as President, Neuromodulation Division, as a result of our acquisition of Advanced Neuromodulation Systems (ANS) in November 2005. From April 1998 to 2005, he served as President, Chief Executive Officer and Director of ANS, when it was a separate company and has since served as President, Neuromodulation Division. Mr. Chavez serves on the Board of Directors of Advanced Medical Optics, Inc., an optical medical device company.

Dr. Fain joined St. Jude Medical in 1997 as a part of our acquisition of Ventritex, Inc., where he had served since 1987. In 1998, he was named Senior Vice President, Clinical Engineering and Regulatory Affairs, Cardiac Rhythm Management. In 2002 he was appointed Senior Vice President for Development and Clinical/Regulatory Affairs for Cardiac Rhythm Management and was promoted to Executive Vice President over those functions in 2005. In July 2007, Dr. Fain became President of our Cardiac Rhythm Management Division.

Mr. Gestin joined St. Jude Medical in 1997 as manager of cardiac rhythm management and catheter product sales in France. He was named Managing Director of St. Jude Medical France in 1999 and was promoted to Vice President, Northern Europe & Africa in 2002. He was named President of SJM Europe, Middle East, Africa and Canada in August 2004, and in January 2008, Mr. Gestin was promoted to President, International Division.

Ms. Song joined St. Jude Medical in 1998 as Senior Vice President, Cardiac Rhythm Management Operations. In May 2002, she was appointed President, Cardiac Surgery Division, and in August 2004, was appointed President, Atrial Fibrillation Division.

Mr. Bae joined St. Jude Medical in 2003 and served as General Counsel and Vice President, Human Resources for the U.S. Division. In September 2006, he was appointed Vice President, Human Resources. Prior to joining St. Jude Medical, Mr. Bae was Director of Litigation for Alpha Therapeutic Corporation, a biopharmaceutical company.

Ms. Craig joined St. Jude Medical in May 2005 as Vice President of Communications and served in that position until being named Vice President, Corporate Relations, in January 2006. Prior to joining St. Jude Medical, Ms. Craig spent 12 years with Smith & Nephew plc, a medical device company headquartered in London, England, where she served as Director of Corporate Affairs from 2002 to 2003 prior to serving as Vice President of U.S. Public Relations and Investor Relations from 2003 to 2005.

13


Table of Contents

Ms. Krop joined St. Jude Medical in July 2006 as Vice President, General Counsel and Corporate Secretary. She previously spent 15 years at General Electric (GE) Company, a diversified industrial corporation, and served as General Counsel of GE Healthcare Bio-Sciences, a $3 billion business acquired by GE, formerly known as Amersham plc.

Mr. Northenscold joined St. Jude Medical in 2001 as Vice President, Finance and Administration of Daig Corporation, a wholly-owned subsidiary of St. Jude Medical. In March 2003, he was named Vice President, Administration and in November 2007 was promoted to Vice President, Information Technology and Chief Information Officer.

Mr. Zurbay joined St. Jude Medical in 2003 as Director of Corporate Finance. In 2004, Mr. Zurbay was named Corporate Controller, and in January 2006 he was named Vice President and Corporate Controller. From 1999 to 2003, he served as Senior Audit Manager at PricewaterhouseCoopers LLP, a global public accounting firm.

Availability of SEC Reports

We make available, free of charge, our 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 (the Exchange Act) as soon as reasonably practical after they are filed or furnished to the U.S. Securities and Exchange Commission (SEC). Such reports are available on our website (http://www.sjm.com) under Our Company – Investor Relations – SEC Filings or can be obtained by contacting our Investor Relations group at 1.800.328.9634 or at St. Jude Medical, Inc., One St. Jude Medical Drive, St. Paul, Minnesota 55117. Information included on our website is not deemed to be incorporated into this Form 10-K.

Item 1A. RISK FACTORS

Our business faces many risks. Any of the risks discussed below, or elsewhere in this Form 10-K or our other SEC filings, could have a material impact on our business, financial condition or results of operations. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also impair our business operations.

We face intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry.

The medical device market is intensely competitive and is characterized by extensive research and development and rapid technological change. Our customers consider many factors when choosing suppliers, including product reliability, clinical outcomes, product availability, inventory consignment, price and product services provided by the manufacturer, and market share can shift as a result of technological innovation and other business factors. Major shifts in industry market share have occurred in connection with product problems, physician advisories and safety alerts, reflecting the importance of product quality in the medical device industry. Our competitors range from small start-up companies to larger companies which have significantly greater resources and broader product offerings than us, and we anticipate that in the coming years, other large companies will enter certain markets in which we currently hold a strong position. For example, Boston Scientific acquired one of our principal competitors, Guidant Corporation, in 2006. In addition, we expect that competition will continue to intensify with the increased use of strategies such as consigned inventory and we have seen increasing price competition as a result of managed care, consolidation among healthcare providers, increased competition and declining reimbursement rates. Product introductions or enhancements by competitors which have advanced technology, better features or lower pricing may make our products or proposed products obsolete or less competitive. As a result, we will be required to devote continued efforts and financial resources to bring our products under development to market, enhance our existing products and develop new products for the medical marketplace. If we fail to develop new products, enhance existing products or compete effectively, our business, financial condition and results of operations will be adversely affected.

We are subject to stringent domestic and foreign medical device regulation which may impede the approval process for our products, hinder our development activities and manufacturing processes and, in some cases, result in the recall or seizure of previously approved products.

Our products, development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA pursuant to the FDCA, by comparable agencies in foreign countries and by other regulatory agencies and governing bodies. Under the FDCA and associated regulations, manufacturers of medical devices must comply with certain regulations that cover the composition, labeling, testing, clinical study, manufacturing, packaging and distribution of medical devices. In addition, medical devices must receive FDA clearance or approval before they can be commercially marketed in the United States, and the FDA may require testing and surveillance programs to monitor the effects of approved products that have been commercialized and can prevent or limit further marketing of a product based on the results of these post-marketing programs. Furthermore, most major markets for medical devices outside the United States require clearance, approval or compliance with certain standards before a product can be commercially marketed. The process of obtaining marketing approval or clearance from the FDA and foreign regulatory agencies for new products or with respect to enhancements or modifications to existing products can take a significant period of time, require the expenditure of substantial resources, involve rigorous pre-clinical and clinical testing, require changes to the products and result in limitations on the indicated uses of the products. We cannot be certain that we will receive the required approval or clearance from the FDA and foreign regulatory agencies for new products or modifications to existing products on a timely basis. The failure to receive approval or clearance for significant new products on a timely basis could have a material adverse effect on our financial condition and results of operations.

14


Table of Contents

At any time after approval of a product, the FDA may conduct periodic inspections to determine compliance with both the FDA’s QSR requirements and/or current medical device reporting regulations. Product approvals by the FDA can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval. The failure to comply with regulatory standards or the discovery of previously unknown problems with a product, component or manufacturer could result in fines, delays or suspensions of regulatory clearances, seizures or recalls of products (with the attendant expenses), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and criminal prosecution, as well as decreased sales as a result of negative publicity and product liability claims, and could have a material adverse effect on our financial condition and results of operations.

We may not be able to meet regulatory quality standards applicable to our manufacturing process.

We are required to register with the FDA as a device manufacturer and as a result, we are subject to periodic inspection by the FDA for compliance with the FDA’s QSR requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures. In addition, the federal Medical Device Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, may contain an anomaly which, if a malfunction were to occur, could cause or contribute to a death or serious injury. Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA. In the European Community, we are required to maintain certain ISO certifications in order to sell products and we undergo periodic inspections by notified bodies to obtain and maintain these certifications. If we or our manufacturers fail to adhere to QSR or ISO requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls or other consequences, which could in turn have a material adverse effect on our financial condition and results of operations.

If we are unable to protect our intellectual property effectively, our financial condition and results of operations could be adversely affected.

Patents and other proprietary rights are essential to our business and our ability to compete effectively with other companies is dependent upon the proprietary nature of our technologies. We also rely upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop, maintain and strengthen our competitive position. We seek to protect these, in part, through confidentiality agreements with certain employees, consultants and other parties. We pursue a policy of generally obtaining patent protection in both the United States and in key foreign countries for patentable subject matter in our proprietary devices and also attempt to review third-party patents and patent applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of others. We currently own numerous United States and foreign patents and have numerous patent applications pending. We are also a party to various license agreements pursuant to which patent rights have been obtained or granted in consideration for cash, cross-licensing rights or royalty payments. We cannot be certain that any pending or future patent applications will result in issued patents, that any current or future patents issued to or licensed by us will not be challenged, invalidated or circumvented or that the rights granted thereunder will provide a competitive advantage to us or prevent competitors from entering markets which we currently serve. Any required license may not be available to us on acceptable terms, if at all. In addition, some licenses may be non-exclusive, and therefore our competitors may have access to the same technologies as us. In addition, we may have to take legal action in the future to protect our trade secrets or know-how or to defend them against claimed infringement of the rights of others. Any legal action of that type could be costly and time consuming to us and we cannot be certain that any lawsuit will be successful. The invalidation of key patents or proprietary rights which we own or an unsuccessful outcome in lawsuits to protect our intellectual property could have a material adverse effect on our financial condition and results of operations.

15


Table of Contents

Pending and future patent litigation could be costly and disruptive to us and may have an adverse effect on our financial condition and results of operations.

We operate in an industry that is susceptible to significant patent litigation and, in recent years, it has been common for companies in the medical device field to aggressively challenge the rights of other companies to prevent the marketing of new devices. Companies that obtain patents for products or processes that are necessary for or useful to the development of our products may bring legal actions against us claiming infringement and at any given time, we generally are involved as both a plaintiff and a defendant in a number of patent infringement and other intellectual property-related actions. Among other matters, we are currently defending a significant ongoing patent infringement action brought against us by one of our principal competitors, Guidant Corporation, which is now part of Boston Scientific. Defending intellectual property litigation is expensive and complex and outcomes are difficult to predict. Any pending or future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and may cause a significant diversion of the efforts of our technical and management personnel. While we intend to defend any such lawsuits vigorously, we cannot be certain that we will be successful. In the event that our right to market any of our products is successfully challenged or if we fail to obtain a required license or are unable to design around a patent, our financial condition and results of operations could be materially adversely affected.

Pending and future product liability claims and litigation may adversely affect our financial condition and results of operations.

The design, manufacture and marketing of medical devices of the types we produce entail an inherent risk of product liability claims. Our products are often used in intensive care settings with seriously ill patients, and many of the medical devices we manufacture and sell are designed to be implanted in the human body for long periods of time or indefinitely. There are a number of factors that could result in an unsafe condition or injury to, or death of, a patient with respect to these or other products which we manufacture or sell, including component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information. Product liability claims may be brought by individuals or by groups seeking to represent a class.

We are currently the subject of various product liability claims, including several lawsuits which may be allowed to proceed as class actions in the United States and are being allowed to proceed as class actions in Canada. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, and the magnitude of the potential loss relating to such lawsuits may remain unknown for substantial periods of time. For example, in January 2000, we initiated a voluntary field action to replace products incorporating Silzone® coating, which was used in certain of our mechanical heart valves and heart valve repair products. After our voluntary field action, we were sued in various jurisdictions and now have cases pending in the United States, Canada and France which have been brought by some patients alleging complications and past or future costs arising either from the surgical removal or, alternatively, from the continued implantation and maintenance of products incorporating Silzone® coating over and above the medical monitoring all replacement heart valve patients receive. Some of the cases involving Silzone®-coated products have been settled, others have been dismissed and still others are ongoing. The complaints in the ongoing individual cases in the United States request damages ranging from $10,000 to $120.5 million and in some cases, seek an unspecified amount, and the complaints in the Canadian class actions request damages ranging from the equivalent of $1.2 million to $1.6 billion at January 3, 2009. We believe that the final resolution of the Silzone®-coated product cases will take years and cannot reasonably estimate the time frame in which any potential settlements or judgments would be paid out or the amounts of any such settlements or judgments. In addition, the cost to defend any future litigation, whether Silzone®-related or not, may be significant. We believe that many settlements and judgments relating to the Silzone® litigation and our other litigation may be covered in whole or in part under our product liability insurance policies and existing reserves. Any costs not covered under our product liability insurance policies and existing reserves could have a material adverse effect on our financial condition and results of operations.

We may be unable to obtain appropriate levels of product liability insurance.

Problems with our products can result in product liability claims or a field action, safety alert or advisory notice relating to the product. Our product liability insurance coverage is designed to help protect us against a catastrophic claim. Our current product liability policies provide $350 million of insurance coverage, with a $100 million deductible per occurrence. We cannot be certain that such insurance will be available or adequate to satisfy future claims or that our insurers will be able to pay claims on insurance policies which they have issued to us. If we are unable to secure appropriate levels of product liability insurance coverage, our financial condition and results of operations could be materially adversely affected.

Our product liability insurers may refuse to cover certain losses on the grounds that such losses are outside the scope of our product liability insurance policies or may agree that such losses are covered losses, but may not be able to meet their current or future payment obligations to us.

One of our product liability insurers has filed suits seeking court orders declaring that they are not required to provide coverage for some of the costs we have incurred or may incur in the future in the Silzone® litigation described above. This insurer, as well as other insurers from whom we have purchased product liability insurance, may deny coverage of these and other past and/or future losses relating to our products on the grounds that such losses are outside the scope of coverage of our insurance policies. To the extent that we suffer losses that are outside of the scope of coverage of our product liability insurance policies, those losses may have an adverse effect on our financial condition and results of operations.

16


Table of Contents

Our remaining product liability insurance for Silzone® claims consists of a number of layers, each of which is covered by one or more insurance companies. Part of our final layer of insurance is covered by a unit of the Kemper Insurance Companies (Kemper), which is currently in “run off” and not issuing new policies or generating any new revenue that could be used to cover claims made under previously-issued policies such as ours. In the event that Kemper is unable to pay part or all of the claims directed to it, we believe that the other insurance carriers in Kemper’s layer will take the position that we will be directly liable for any claims and costs that Kemper is unable to pay and that the other insurance carriers in that layer will not provide coverage for Kemper’s portion. If Kemper or any other insurance companies are unable to meet their respective obligations to us, we could incur substantial losses which could have an adverse effect on our financial condition and results of operations.

The loss of any of our sole-source suppliers or an increase in the price of inventory supplied to us could have an adverse effect on our business, financial condition and results of operations.

We purchase certain supplies used in our manufacturing processes from single sources due to quality considerations, costs or constraints resulting from regulatory requirements. Agreements with certain suppliers are terminable by either party upon short notice and we have been advised periodically by some suppliers that in an effort to reduce their potential product liability exposure, they may terminate sales of products to customers that manufacture implantable medical devices. While some of these suppliers have modified their positions and have indicated a willingness to continue to provide a product temporarily until an alternative vendor or product can be qualified (or even to reconsider the supply relationship), where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly. This is largely due to the FDA approval system, which mandates validation of materials prior to use in our products, and the complex nature of manufacturing processes employed by many suppliers. In addition, we may lose a sole-source supplier due to, among other things, the acquisition of such a supplier by a competitor (which may cause the supplier to stop selling its products to us) or the bankruptcy of such a supplier, which may cause the supplier to cease operations. A reduction or interruption by a sole-source supplier of the supply of materials or key components used in the manufacturing of our products or an increase in the price of those materials or components could adversely affect our business, financial condition and results of operations.

Cost containment pressures and domestic and foreign legislative or administrative reforms resulting in restrictive reimbursement practices of third-party payors or preferences for alternate therapies could decrease the demand for products purchased by our customers, the prices which they are willing to pay for those products and the number of procedures using our devices.

Our products are purchased principally by healthcare providers that typically bill various third-party payors, such as governmental programs (e.g., Medicare and Medicaid), private insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of customers to obtain appropriate reimbursement for their services and the products they provide from government and third-party payors is critical to the success of medical technology companies. The availability of reimbursement affects which products customers purchase and the prices they are willing to pay. Reimbursement varies from country to country and can significantly impact the acceptance of new technology. After we develop a promising new product, we may find limited demand for the product unless reimbursement approval is obtained from private and governmental third-party payors.

Major third-party payors for healthcare provider services in the United States and abroad continue to work to contain healthcare costs. The introduction of cost containment incentives, combined with closer scrutiny of healthcare expenditures by both private health insurers and employers, has resulted in increased discounts and contractual adjustments to healthcare provider charges for services performed and in the shifting of services between inpatient and outpatient settings. Initiatives to limit the growth of healthcare costs, including price regulation, are also underway in several countries in which we do business. Implementation of healthcare reforms in the United States and in significant overseas markets such as Germany, Japan and other countries may limit the price of, or the level at which, reimbursement is provided for our products and adversely affect both our pricing flexibility and the demand for our products. Healthcare providers may respond to such cost-containment pressures by substituting lower cost products or other therapies for our products.

Further legislative or administrative reforms to the U.S. or international reimbursement systems that significantly reduce reimbursement for procedures using our medical devices or deny coverage for such procedures, or adverse decisions relating to our products by administrators of such systems in coverage or reimbursement issues, would have an adverse impact on the products, including clinical products, purchased by our customers and the prices our customers are willing to pay for them. This in turn would have an adverse effect on our financial condition and results of operations.

17


Table of Contents

Our failure to comply with restrictions relating to reimbursement and regulation of healthcare goods and services may subject us to penalties and adversely affect our financial condition and results of operations.

Our devices are subject to regulation regarding quality and cost by the United States Department of Health and Human Services, including the Centers for Medicare and Medicaid Services (CMS), as well as comparable state and foreign agencies responsible for reimbursement and regulation of healthcare goods and services. Foreign governments also impose regulations in connection with their healthcare reimbursement programs and the delivery of healthcare goods and services. U.S. federal government healthcare laws apply when we submit a claim on behalf of a U.S. federal healthcare program beneficiary, or when a customer submits a claim for an item or service that is reimbursed under a U.S. federal government funded healthcare program, such as Medicare or Medicaid. The principal U.S. federal laws implicated include those that prohibit the filing of false or improper claims for federal payment, those that prohibit unlawful inducements for the referral of business reimbursable under federally-funded healthcare programs, known as the anti-kickback laws, and those that prohibit healthcare service providers seeking reimbursement for providing certain services to a patient who was referred by a physician that has certain types of direct or indirect financial relationships with the service provider, known as the Stark law.

The laws applicable to us are subject to evolving interpretations. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal and civil penalties, including, for example, exclusion from participation as a supplier of product to beneficiaries covered by CMS. If we are excluded from participation based on such an interpretation, it could adversely affect our financial condition and results of operations.

Consolidation in the healthcare industry could lead to demands for price concessions or limit or eliminate our ability to sell to certain of our significant market segments.

The cost of healthcare has risen significantly over the past decade and numerous initiatives and reforms initiated by legislators, regulators and third-party payors to curb these costs have resulted in a consolidation trend in the medical device industry as well as among our customers, including healthcare providers. This in turn has resulted in greater pricing pressures and limitations on our ability to sell to important market segments, as group purchasing organizations, independent delivery networks and large single accounts, such as the Veterans Administration in the United States, continue to consolidate purchasing decisions for some of our healthcare provider customers. We expect that market demand, government regulation, third-party reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances which may exert further downward pressure on the prices of our products and adversely impact our business, financial condition and results of operations.

Failure to integrate acquired businesses into our operations successfully could adversely affect our business.

As part of our strategy to develop and identify new products and technologies, we have made several acquisitions in recent years and may make additional acquisitions in the future. Our integration of the operations of acquired businesses requires significant efforts, including the coordination of information technologies, research and development, sales and marketing, operations, manufacturing and finance. These efforts result in additional expenses and involve significant amounts of management’s time that cannot then be dedicated to other projects. Our failure to manage successfully and coordinate the growth of the combined company could also have an adverse impact on our business. In addition, we cannot be certain that the businesses we acquire will become profitable or remain so. If our acquisitions are not successful, we may record unexpected impairment charges. Factors that will affect the success of our acquisitions include:

 

 

 

 

the presence or absence of adequate internal controls and/or significant fraud in the financial systems of acquired companies;

 

adverse developments arising out of investigations by governmental entities of the business practices of acquired companies;

 

any decrease in customer loyalty and product orders caused by dissatisfaction with the combined companies’ product lines and sales and marketing practices, including price increases;

 

our ability to retain key employees; and

 

the ability of the combined company to achieve synergies among its constituent companies, such as increasing sales of the combined company’s products, achieving cost savings and effectively combining technologies to develop new products.

18


Table of Contents

The success of many of our products depends upon strong relationships with physicians.

If we fail to maintain our working relationships with physicians, many of our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support our products. The research, development, marketing and sales of many of our new and improved products is dependent upon our maintaining working relationships with physicians. We rely on these professionals to provide us with considerable knowledge and experience regarding our products and the marketing of our products. Physicians assist us as researchers, marketing consultants, product consultants, inventors and as public speakers. If we are unable to maintain our strong relationships with these professionals and continue to receive their advice and input, the development and marketing of our products could suffer, which could have a material adverse effect on our financial condition and results of operations.

Instability in international markets or foreign currency fluctuations could adversely affect our results of operations.

Our products are currently marketed in more than 100 countries around the world, with our largest geographic markets outside of the United States being Europe, Japan and Asia Pacific. As a result, we face currency and other risks associated with our international sales. We are exposed to foreign currency exchange rate fluctuations due to transactions denominated primarily in Euros, Japanese Yen, Canadian Dollars, Australian Dollars, Brazilian Reals, British Pounds and Swedish Kronor, which may potentially reduce the U.S. Dollars we receive for sales denominated in any of these foreign currencies and/or increase the U.S. Dollars we report as expenses in these currencies, thereby affecting our reported consolidated revenues and net earnings. Fluctuations between the currencies in which we do business have caused and will continue to cause foreign currency transaction gains and losses. We cannot predict the effects of currency exchange rate fluctuations upon our future operating results because of the number of currencies involved, the variability of currency exposures and the volatility of currency exchange rates.

In addition to foreign currency exchange rate fluctuations, there are a number of additional risks associated with our international operations, including those related to:

 

 

 

 

the imposition of or increase in import or export duties, surtaxes, tariffs or customs duties;

 

the imposition of import or export quotas or other trade restrictions;

 

foreign tax laws and potential increased costs associated with overlapping tax structures;

 

longer accounts receivable cycles in certain foreign countries, whether due to cultural, exchange rate or other factors;

 

changes in regulatory requirements in international markets in which we operate;

 

inquiries into possible improprieties in our international operations, such as our inclusion in the report of the Independent Inquiry Committee into the United Nations (U.N.) Oil-For-Food Programme as allegedly having made payments to the Iraqi government in connection with certain product sales which we made to Iraq under this program from 2000 to 2003; and

 

economic and political instability in foreign countries.

The medical device industry is the subject of numerous governmental investigations into marketing and other business practices. These investigations could result in the commencement of civil and/or criminal proceedings, substantial fines, penalties and/or administrative remedies, divert the attention of our management and have an adverse effect on our financial condition and results of operations.

In October 2005, the U.S. Department of Justice, acting through the U.S. Attorney’s office in Boston, commenced an industry-wide investigation into whether the provision of payments and/or services by makers of implantable cardiac rhythm devices to doctors or other persons constitutes improper inducements under the federal health care program anti-kickback law. As part of this investigation, we received a civil subpoena from the U.S. Attorney’s office in Boston requesting documents created since January 2000 regarding our practices related to pacemakers, ICDs, lead systems and related products marketed by our CRM segment. We understand that our principal competitors in the CRM therapy areas received similar civil subpoenas. We received an additional subpoena from the U.S. Attorney’s office in Boston in September 2006, requesting documents created since January 2002 related to certain employee expense reports and certain pacemaker and ICD purchasing arrangements. In December 2008, the U.S. Attorney’s Office in Boston delivered a third subpoena issued by the Department of Health & Human Services Office of Inspector General requesting the production of documents relating to implantable cardiac rhythm device and pacemaker warranty claims.

In February 2006, we received a subpoena from the SEC requesting that we produce documents concerning transactions under the U.N. Oil-for-Food Programme.

In July 2007, we received a civil subpoena from the U.S. Department of Health and Human Services, Office of the Inspector General requesting documents created during the period from 2003 through 2006 regarding our relationships with ten Ohio hospitals. We have received follow-up requests from the U.S. Department of Justice and the U.S. Attorney’s Office in Cleveland regarding this matter.

19


Table of Contents

In October 2008, we received a letter from the Civil Division of the U.S. Department of Justice stating that we are under investigation for potential False Claims Act and common law violations relating to the sale of our surgical ablation devices. The Department of Justice is investigating whether companies marketed surgical ablation devices for off-label treatment of atrial fibrillation. We understand that other manufacturers of medical devices used in the treatment of atrial fibrillation received similar letters. The Department of Justice’s investigation is focused on our EpicorTM ablation devices. The letter requests that we provide documents from January 1, 2005, to present relating to FDA approval and marketing of EpicorTM ablation devices.

We are fully cooperating with these investigations and are responding to these requests. However, we cannot predict when these investigations will be resolved, the outcome of these investigations or their impact on the Company. An adverse outcome in one or more of these investigations could include the commencement of civil and/or criminal proceedings, substantial fines, penalties and/or administrative remedies, including exclusion from government reimbursement programs. In addition, resolution of any of these matters could involve the imposition of additional and costly compliance obligations. Finally, if these investigations continue over a long period of time, they could divert the attention of management from the day-to-day operations of our business and impose significant administrative burdens on us. These potential consequences, as well as any adverse outcome from these investigations, could have a material adverse effect on our financial condition and results of operations.

Regulatory actions arising from the concern over Bovine Spongiform Encephalopathy may limit our ability to market products containing bovine material.

Our Angio-Seal™ vascular closure device, as well as our vascular graft products, contain bovine collagen. In addition, some of the tissue heart valves we market, such as our Biocor® and Epic™ tissue heart valves, incorporate bovine pericardial material. Certain medical device regulatory agencies may prohibit the sale of medical devices that incorporate any bovine material because of concerns over BSE, sometimes referred to as “mad cow disease,” a disease which may be transmitted to humans through the consumption of beef. While we are not aware of any reported cases of transmission of BSE through medical products and are cooperating with regulatory agencies considering these issues, the suspension or revocation of authority to manufacture, market or distribute products containing bovine material, or the imposition of a regulatory requirement that we procure material for these products from alternate sources, could result in lost market opportunities, harm the continued commercialization and distribution of such products and impose additional costs on us. Any of these consequences could in turn have a material adverse effect on our financial condition and results of operations.

We are not insured against all potential losses. Natural disasters or other catastrophes could adversely affect our business, financial condition and results of operations.

Our facilities could be materially damaged by earthquakes, hurricanes and other natural disasters or catastrophic circumstances, including acts of war. For example, we have significant CRM facilities located in Sylmar and Sunnyvale, California. Earthquake insurance in California is currently difficult to obtain, extremely costly and restrictive with respect to scope of coverage. Our earthquake insurance for these California facilities provides $10 million of insurance coverage in the aggregate, with a deductible equal to 5% of the total value of the facility and contents involved in the claim. Consequently, despite this insurance coverage, we could incur uninsured losses and liabilities arising from an earthquake near one or both of our California facilities as a result of various factors, including the severity and location of the earthquake, the extent of any damage to our facilities, the impact of an earthquake on our California workforce and on the infrastructure of the surrounding communities and the extent of damage to our inventory and work in process. While we believe that our exposure to significant losses from a California earthquake could be partially mitigated by our ability to manufacture some of our CRM products at our manufacturing facilities in Sweden and Puerto Rico, the losses could have a material adverse effect on our business for an indeterminate period of time before this manufacturing transition is complete and operates without significant problems. Furthermore, our manufacturing facilities in Puerto Rico may suffer damage as a result of hurricanes which are frequent in the Caribbean and which could result in lost production and additional expenses to us to the extent any such damage is not fully covered by our hurricane and business interruption insurance.

Even with insurance coverage, natural disasters or other catastrophic events, including acts of war, could cause us to suffer substantial losses in our operational capacity and could also lead to a loss of opportunity and to a potential adverse impact on our relationships with our existing customers resulting from our inability to produce products for them, for which we would not be compensated by existing insurance. This in turn could have a material adverse effect on our financial condition and results of operations.

20


Table of Contents

Our operations are subject to environmental, health and safety laws and regulations that could require us to incur material costs.

Our operations are subject to environmental, health and safety laws and regulations concerning, among other things, the generation, handling, transportation and disposal of hazardous substances or wastes, particularly ethylene oxide, the cleanup of hazardous substance releases, and emissions or discharges into the air or water. We have incurred and expect to incur expenditures in the future in connection with compliance with environmental, health and safety laws and regulations. New laws and regulations, violations of these laws or regulations, stricter enforcement of existing requirements, or the discovery of previously unknown contamination could require us to incur costs or become the basis for new or increased liabilities that could be material.

Failure to successfully implement a new enterprise resource planning (ERP) system could adversely affect our business.

We are in the process of converting to a new ERP system. Failure to smoothly execute the implementation of the ERP system could adversely affect the Company’s business, financial condition and results of operations.

The disruption in the global financial markets and the economic downturn may adversely impact the availability and cost of credit and customer purchasing and payment patterns.

Our ability to refinance our indebtedness and to obtain financing for acquisitions or other general corporate and commercial purposes will depend on our operating and financial performance and is also subject to prevailing economic conditions and to financial, business and other factors beyond our control. Recently, global credit markets and the financial services industry have been experiencing a period of unprecedented turmoil characterized by the bankruptcy, failure or sale of various financial institutions, a general tightening of credit, and an unprecedented level of market intervention from the United States and other governments. These events have adversely affected the U.S. and world economy, and may adversely affect the availability and cost of financing. Disruptions in the global financial markets and the related economic downturn could also negatively impact customer purchasing and payment patterns and also have a material adverse effect on our financial condition and results of operations. There can be no assurances as to the length or severity of this period of disruption and the related economic downturn.

 

 

Item 1B.

UNRESOLVED STAFF COMMENTS

None.

 

 

Item 2.

PROPERTIES

We own our principal executive offices, which are located in St. Paul, Minnesota. Our manufacturing facilities are located in California, Minnesota, Arizona, South Carolina, Texas, New Jersey, Oregon, Canada, Brazil, Puerto Rico, Sweden and Thailand. We own approximately 63%, or 544,092 square feet, of our total manufacturing space. We also maintain sales and administrative offices in the United States at 37 locations in 17 states and outside the United States at 96 locations in 35 countries. With the exception of 13 locations, all of these locations are leased.

We believe that all buildings, machinery and equipment are in good condition, suitable for their purposes and are maintained on a basis consistent with sound operations. In late 2007, we began construction on a facility in St. Paul, Minnesota, which will be used for manufacturing, research and development as well as general office space, and is expected to be completed in early 2009. In late 2008, our Cardiovascular division completed a 100,000-square-foot expansion to its Woodridge facility in St. Paul, Minnesota. The expanded facility is being used for tissue and mechanical heart valve manufacturing and research and development. In Liberty, South Carolina, we are in the process of expanding our CRM manufacturing facilities, and we added a 60,000-square-foot addition in late 2008. Another CRM manufacturing facility in Liberty, South Carolina is scheduled to be completed in early 2009. Additionally, we purchased a manufacturing facility in Puerto Rico, which will be used for manufacturing CRM products, and we purchased another manufacturing facility in Thailand in conjunction with our Radi Medical Systems acquisition. We believe that we have sufficient space for our current operations and for foreseeable expansion in the next few years. We plan to open additional manufacturing facilities in other cost advantage locations in 2010 and 2011 as part of our global business expansion plan.

 

 

Item 3.

LEGAL PROCEEDINGS

We are the subject of various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of our business. Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. We record a liability in our consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments, where we have assessed that a loss is probable and an amount can be reasonably estimated. Our significant legal proceedings are discussed in Note 5 of the Consolidated Financial Statements in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K and incorporated herein by reference. While it is not possible to predict the outcome for most of the legal proceedings discussed in Note 5, the costs associated with such proceedings could have a material adverse effect on our consolidated results of operations, financial position or cash flows of a future period.

21


Table of Contents


 

 

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 the 2008 fiscal year.

PART II

 

 

Item 5.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

There were no sales of unregistered securities during the 2008 fiscal year, and we did not repurchase any of our shares during the fourth quarter of the 2008 fiscal year. The information set forth under the Stock Exchange Listings caption in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K is incorporated herein by reference. We have not declared or paid any cash dividends during the past two years. We currently intend to retain our earnings for use in the operation and expansion of our business and therefore do not anticipate paying any cash dividends in the foreseeable future.

 

 

Item 6.

SELECTED FINANCIAL DATA

The information set forth under the caption Five-Year Summary Financial Data in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K is incorporated herein by reference.

 

 

Item 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The information set forth under Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K is incorporated herein by reference.

 

 

Item 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The information set forth under the Market Risk section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K is incorporated herein by reference.

 

 

Item 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The Consolidated Financial Statements and Notes thereto and the Reports of Independent Registered Public Accounting Firm set forth in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K are incorporated herein by reference.

 

 

Item 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

 

 

Item 9A.

CONTROLS AND PROCEDURES

Under the supervision and with the participation of our management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act of 1934). Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of January 3, 2009.

Management’s annual report on our internal control over financial reporting is provided in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K and incorporated herein by reference. The effectiveness of our internal control over financial reporting as of January 3, 2009 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report which is provided in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders and filed as Exhibit 13 to this Form 10-K and incorporated herein by reference.

22


Table of Contents

During the fiscal quarter ended January 3, 2009, there were no changes in our internal control 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, our internal control over financial reporting.

 

 

Item 9B.

OTHER INFORMATION

None.

PART III

 

 

Item 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information set forth under the captions Proposal to Elect Directors, Director Nomination Process, Director Independence and Audit Committee Financial Literacy and Expertise and Section 16(a) Beneficial Ownership Reporting Compliance in St. Jude Medical’s Proxy Statement for the 2009 Annual Meeting of Shareholders is incorporated herein by reference. The information set forth under the caption Executive Officers of the Registrant in Part I, Item 1 of this Form 10-K is incorporated herein by reference.

We have adopted a Code of Business Conduct for our principal executive officer, principal financial officer, principal accounting officer, corporate controller and all other employees. We have made our Code of Business Conduct available on our website (http://www.sjm.com) under the Our Company – About St. Jude Medical – Corporate Governance section and it is available in print to any shareholder who submits a request to St. Jude Medical, Inc., One St. Jude Medical Drive, St. Paul, Minnesota 55117, Attention: Corporate Secretary. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of our Code of Business Conduct by posting such information on our website at the web address and location specified above. Information included on our website is not deemed to be incorporated into this Form 10-K.

 

 

Item 11.

EXECUTIVE COMPENSATION

The information set forth under the captions Compensation of Directors, Executive Compensation and Compensation Committee Interlocks and Insider Participation in St. Jude Medical’s Proxy Statement for the 2009 Annual Meeting of Shareholders 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 captions Share Ownership of Management and Directors and Certain Beneficial Owners in St. Jude Medical’s Proxy Statement for the 2009 Annual Meeting of Shareholders is incorporated herein by reference.

 

 

Item 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information set forth under the captions Related Person Transactions and Director Independence and Audit Committee Financial Literacy and Expertise in St. Jude Medical’s Proxy Statement for the 2009 Annual Meeting of Shareholders 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 Independent Registered Public Accounting Firm in St. Jude Medical’s Proxy Statement for the 2009 Annual Meeting of Shareholders is incorporated herein by reference.

23


Table of Contents

PART IV

 

 

Item 15.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES


 

 

(a)

List of documents filed as part of this Report


 

 

 

 

 

(1)

Financial Statements

 

 

 

 

 

 

The following Consolidated Financial Statements of St. Jude Medical and Reports of Independent Registered Public Accounting Firm as set forth in the Financial Report included in St. Jude Medical’s 2008 Annual Report to Shareholders are incorporated herein by reference from Exhibit 13 attached hereto:

 

 

 

 

 

 

 

Reports of Independent Registered Public Accounting Firm

 

 

 

 

 

 

 

Consolidated Statements of Earnings – Fiscal Years ended January 3, 2009, December 29, 2007, and December 30, 2006

 

 

 

 

 

 

 

Consolidated Balance Sheets – January 3, 2009 and December 29, 2007

 

 

 

 

 

 

 

Consolidated Statements of Shareholders’ Equity – Fiscal Years ended January 3, 2009, December 29, 2007, and December 30, 2006

 

 

 

 

 

 

 

Consolidated Statements of Cash Flows – Fiscal Years ended January 3, 2009, December 29, 2007, and December 30, 2006

 

 

 

 

 

 

 

Notes to the Consolidated Financial Statements

 

 

 

 

 

(2)

Financial Statement Schedules

 

 

 

 

 

 

Schedule II – Valuation and Qualifying Accounts, is filed as part of this Form 10-K (see Item 15(c)).

 

 

 

 

 

 

All other financial statement schedules not listed above have been omitted because the required information is included in the Consolidated Financial Statements or Notes thereto, or is not applicable.

 

 

 

 

 

(3)

Exhibits

 

 

 

 

 

 

Pursuant to Item 601(b)(4)(iii) of Regulation S-K, copies of certain instruments defining the rights of holders of certain long-term debt of St. Jude Medical are not filed, and in lieu thereof, we agree to furnish copies thereof to the SEC upon request.

 

 

 

Exhibit

 

Exhibit Index

 

 

 

2.3

 

Agreement and Plan of Merger between St. Jude Medical, Inc. and Advanced Neuromodulation Systems, Inc., dated as of October 15, 2005, is incorporated by reference to Exhibit 2.1 of St. Jude Medical’s Current Report on Form 8-K filed on October 17, 2005.

 

 

 

3.1

 

Articles of Incorporation, as amended on May 9, 2008, are incorporated by reference to Exhibit 3.1 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended June 28, 2008.

 

 

 

3.2

 

Bylaws, as amended and restated as of February 25, 2005, are incorporated by reference to Exhibit 3.1 of St. Jude Medical’s Current Report on Form 8-K filed on March 2, 2005.

 

 

 

4.1

 

Indenture, dated as of December 12, 2005, between St. Jude Medical, Inc. and U.S. Bank National Association, as trustee, is incorporated by reference to Exhibit 4.1 of St. Jude Medical’s Current Report on Form 8-K filed on December 12, 2005.

24


Table of Contents


 

 

 

Exhibit

 

Exhibit Index

 

 

 

4.2

 

Indenture between St. Jude Medical, Inc. and U.S. Bank National Association, as trustee, dated as of April 25, 2007 (including form of Convertible Debenture due 2008), is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

4.3

 

Registration Rights Agreement between St. Jude Medical, Inc. and Banc of America Securities LLC, dated as of April 25, 2007, is incorporated by reference to Exhibit 4.2 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

10.1

 

Form of Indemnification Agreement that St. Jude Medical, Inc. has entered into with officers and directors is incorporated by reference to Exhibit 10(d) of St. Jude Medical’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 to Appendix B of St. Jude Medical’s Proxy Statement on Schedule 14A filed on April 7, 2004. *

 

 

 

10.3

 

St. Jude Medical, Inc. Management Savings Plan, restated effective January 1, 2008, is incorporated by reference to Exhibit 10.1 of St. Jude Medical’s Current Report on Form 8-K filed on October 29, 2008. *

 

 

 

10.4

 

Retirement Plan for members of the Board of Directors, as amended on March 15, 1995, is incorporated by reference to Exhibit 10.6 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 1994. *

 

 

 

10.5

 

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

 

 

 

10.6

 

Amendment No. 1, dated as of August 3, 2006, to the St. Jude Medical, Inc. 2000 Employee Stock Purchase Savings Plan is incorporated by reference to Exhibit 10.5 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. *

 

 

 

10.7

 

St. Jude Medical, Inc. 2007 Employee Stock Purchase Plan is incorporated by reference to Exhibit 10.4 to St. Jude Medical’s Current Report on Form 8-K filed on May 18, 2007. *

 

 

 

10.8

 

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

 

 

 

10.9

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 1994 Stock Option Plan is incorporated by reference to Exhibit 10.1 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.10

 

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

 

 

 

10.11

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 1997 Stock Option Plan is incorporated by reference to Exhibit 10.2 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.12

 

St. Jude Medical, Inc. 2000 Stock Plan, as amended, is incorporated by reference to Exhibit 10.4 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006. *

 

 

 

10.13

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 2000 Stock Plan is incorporated by reference to Exhibit 10.3 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.14

 

St. Jude Medical, Inc. 2002 Stock Plan, as amended, is incorporated by reference to Exhibit 10.5 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006. *

25


Table of Contents


 

 

 

Exhibit

 

Exhibit Index

 

 

 

10.15

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 2002 Stock Plan is incorporated by reference to Exhibit 10.4 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.16

 

Form of Non-Qualified Stock Option Agreement under the St. Jude Medical, Inc. 2002 Stock Plan, as amended, is incorporated by reference to Exhibit 10.14 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2004. *

 

 

 

10.17

 

St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on May 16, 2006. *

 

 

 

10.18

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.5 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.19

 

Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Current Report on Form 8-K filed on May 16, 2006. *

 

 

 

10.20

 

Form of Non-Qualified Stock Option Agreement for Employees under the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.4 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. *

 

 

 

10.21

 

St. Jude Medical, Inc. 2007 Stock Incentive Plan, as amended (2008), is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on May 12, 2008. *

 

 

 

10.22

 

Amendment, dated as of October 23, 2008, to the St. Jude Medical, Inc. 2007 Stock Incentive Plan is incorporated by reference to Exhibit 10.6 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 27, 2008. *

 

 

 

10.23

 

Form of Non-Qualified Stock Option Agreement and related Notice of Non-Qualified Stock Option Grant under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Current Report on Form 8-K filed on May 18, 2007. *

 

 

 

10.24

 

Form of Restricted Stock Award Agreement and related Restricted Stock Award Certificate under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.3 to St. Jude Medical’s Current Report on Form 8-K filed on May 18, 2007. *

 

 

 

10.25

 

St. Jude Medical, Inc. Amended and Restated 1995 Stock Option Plan (formerly the Quest Medical, Inc. 1995 Stock Option Plan) is incorporated by reference to Exhibit 10.12 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

 

 

 

10.26

 

St. Jude Medical, Inc. Amended and Restated 1998 Stock Option Plan (formerly the Quest Medical, Inc. 1998 Stock Option Plan) is incorporated by reference to Exhibit 10.13 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

 

 

 

10.27

 

St. Jude Medical, Inc. Amended and Restated 2000 Stock Option Plan (formerly the Advanced Neuromodulation Systems, Inc. 2000 Stock Option Plan) is incorporated by reference to Exhibit 10.14 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

 

 

 

10.28

 

St. Jude Medical, Inc. Amended and Restated 2001 Employee Stock Option Plan (formerly the Advanced Neuromodulation Systems, Inc. 2001 Employee Stock Option Plan) is incorporated by reference to Exhibit 10.15 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

 

 

 

10.29

 

St. Jude Medical, Inc. Amended and Restated 2002 Stock Option Plan (formerly the Advanced Neuromodulation Systems, Inc. 2002 Stock Option Plan) is incorporated by reference to Exhibit 10.16 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

26


Table of Contents


 

 

 

Exhibit

 

Exhibit Index

 

 

 

10.30

 

St. Jude Medical, Inc. Amended and Restated 2004 Stock Incentive Plan (formerly the Advanced Neuromodulation Systems, Inc. 2004 Stock Incentive Plan) is incorporated by reference to Exhibit 10.17 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 31, 2005. *

 

 

 

10.31

 

Form of Severance Agreement between St. Jude Medical, Inc. and executive officers is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on January 7, 2009. *

 

 

 

10.32

 

Employment Agreement, dated as of April 1, 2002, between Advanced Neuromodulation Systems, Inc. and Christopher G. Chavez is incorporated by reference to Exhibit 10.16 of Advanced Neuromodulation Systems’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2002. *

 

 

 

10.33

 

Amendment, dated as of July 27, 2006, between Advanced Neuromodulation Systems, Inc. and Christopher G. Chavez, to Employment Agreement, effective as of April 1, 2002, between Advanced Neuromodulation Systems, Inc. and Christopher G. Chavez is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Current Report on Form 8-K filed on August 2, 2006. *

 

 

 

10.34

 

Consulting Agreement, dated as of November 30, 2007, between St. Jude Medical, Inc. and Michael J. Coyle is incorporated by reference to Exhibit 10.27 of St. Jude Medical’s Annual Report on Form 10-K for the year ended December 29, 2007. *

 

 

 

10.35

 

Stock Purchase Plan Engagement Agreement between St. Jude Medical, Inc. and Banc of America Securities LLC, dated as of April 21, 2006, is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on April 21, 2006.

 

 

 

10.36

 

Stock Purchase Plan Engagement Agreement between St. Jude Medical, Inc. and Banc of America Securities LLC, dated as of January 29, 2007, is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on January 29, 2007.

 

 

 

10.37

 

Purchase Agreement between St. Jude Medical, Inc. and Banc of America Securities LLC, dated as of April 19, 2007, is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

10.38

 

Confirmation of OTC Convertible Note Hedge, effective April 25, 2007, is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

10.39

 

Confirmation of OTC Warrant Transaction, effective April 25, 2007, is incorporated by reference to Exhibit 10.3 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

10.40

 

Stock Purchase Plan Engagement Agreement between St. Jude Medical, Inc. and Banc of America Securities LLC, dated as of April 25, 2007, is incorporated by reference to Exhibit 10.4 to St. Jude Medical’s Current Report on Form 8-K filed on April 25, 2007.

 

 

 

10.41

 

Settlement Agreement, dated as of July 29, 2006, by and between St. Jude Medical, Inc. and its affiliates named therein and Boston Scientific Corporation and its affiliates named therein is incorporated by reference to Exhibit 10.3 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006.

 

 

 

10.42

 

CRM License Agreement, effective as of July 29, 2006, between St. Jude Medical, Inc. and Boston Scientific Corporation is incorporated by reference to Exhibit 10.6 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006.

 

 

 

10.43

 

SCS License Agreement, effective as of July 29, 2006, between St. Jude Medical, Inc. and Boston Scientific Corporation is incorporated by reference to Exhibit 10.7 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006.

 

 

 

10.44

 

Settlement Agreement, dated as of June 26, 2007, by and between St. Jude Medical, Inc. and its affiliates named therein and Mirowski Family Ventures LLC is incorporated by reference to Exhibit 10.9 of St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007.

27


Table of Contents


 

 

 

Exhibit

 

Exhibit Index

 

 

 

10.45

 

Multi-Year $1,000,000,000 Credit Agreement dated as of December 13, 2006 among St. Jude Medical, Inc., as the Borrower, Bank of America, N.A., as Administrative Agent, L/C Issuer and Lender, and the other Lenders Party thereto is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on December 13, 2006.

 

 

 

10.46

 

Credit Agreement dated as of December 18, 2008 among St. Jude Medical, Inc., as the Borrower, Bank of America, N.A., as Administrative Agent and Lender, and the other Lenders party thereto, is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on December 24, 2008.

 

 

 

12

 

Computation of Ratio of Earnings to Fixed Charges. #

 

 

 

13

 

Portions of St. Jude Medical’s 2008 Annual Report to Shareholders. #

 

 

 

21

 

Subsidiaries of the Registrant. #

 

 

 

23

 

Consent of Independent Registered Public Accounting Firm. #

 

 

 

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.


28


Table of Contents

 

 

(b)

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

 

 

(c)

Schedules:

SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS
(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance
at Beginning
of Year

 

Additions

 

Deductions

 

 

 

 

 

 

Charged to
Expense

 

 

 

 

 

 

 

Balance at
End of Year

 

Description

 

 

 

Other (1)

 

Write-offs (2)

 

Other (3)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Allowance for doubtful accounts:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fiscal year ended

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

$

26,652

 

$

9,569

 

$

 

$

(6,275

)

$

(975

)

$

28,971

 

December 29, 2007

 

$

24,928

 

$

6,939

 

$

 

$

(4,648

)

$

(567

)

$

26,652

 

December 30, 2006

 

$

33,319

 

$

2,037

 

$

563

 

$

(10,991

)

$

 

$

24,928

 


 

 

(1)

In 2006, the $563 of other additions represents the effects of changes in foreign currency translation.

 

 

(2)

Uncollectible accounts written off, net of recoveries.

 

 

(3)

In 2008 and 2007 the $975 and $567, respectively, of other deductions represent the effects of changes in foreign currency translation.

29


Table of Contents

SIGNATURES

Pursuant to the requirements of Section 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:

February 27, 2009

By

/s/ DANIEL J. STARKS

 

 

 

 

Daniel J. Starks

 

 

 

 

Chairman, President and Chief Executive Officer

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

By

/s/ JOHN C. HEINMILLER

 

 

 

 

John C. Heinmiller

 

 

 

 

Executive Vice President 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 27th day of February, 2009.

 

 

 

/s/ DANIEL J. STARKS

 

Chairman of the Board

Daniel J. Starks

 

 

 

 

 

*

 

Director

John W. Brown

 

 

 

 

 

*

 

Director

Richard R. Devenuti

 

 

 

 

 

*

 

Director

Stuart M. Essig

 

 

 

 

 

*

 

Director

Thomas H. Garrett III

 

 

 

 

 

*

 

Director

Barbara B. Hill

 

 

 

 

 

*

 

Director

Michael A. Rocca

 

 

 

 

 

*

 

Director

Stefan K. Widensohler

 

 

 

 

 

*

 

Director

Wendy L. Yarno

 

 


 

 

* By:

/s/ PAMELA S. KROP

 

Pamela S. Krop

 

Attorney-in-Fact

30


EX-12 2 stjude090797_ex12.htm COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES

Exhibit 12

ST. JUDE MEDICAL, INC.
COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FISCAL YEAR

 

 

 

2008

 

2007

 

2006

 

2005

 

2004

 

EARNINGS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings before income taxes

 

$

630,741

 

$

744,305

 

$

720,641

 

$

621,404

 

$

537,192

 

 

Plus fixed charges:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense (1)

 

 

22,581

 

 

38,229

 

 

33,883

 

 

10,028

 

 

4,810

 

Rent interest factor (2)

 

 

9,527

 

 

9,144

 

 

8,190

 

 

7,659

 

 

5,778

 

TOTAL FIXED CHARGES

 

 

32,108

 

 

47,373

 

 

42,073

 

 

17,687

 

 

10,588

 

 

EARNINGS BEFORE INCOME TAXES AND FIXED CHARGES

 

$

662,849

 

$

791,678

 

$

762,714

 

$

639,091

 

$

547,780

 

RATIO OF EARNINGS TO FIXED CHARGES

 

 

20.6

 

 

16.7

 

 

18.1

 

 

36.1

 

 

51.7

 


 

 

(1)

Interest expense consists of interest on indebtedness and amortization of debt issuance costs.

 

 

(2)

Approximately one-third of rental expense is deemed representative of the interest factor.



EX-13 3 stjude090797_ex13.htm PORTIONS OF ST. JUDE MEDICAL'S 2008 ANNUAL REPORT TO SHAREHOLDERS

Exhibit 13

Management’s Discussion and Analysis of Financial Condition and Results of Operations

OVERVIEW

Our business is focused on the development, manufacture and distribution of cardiovascular medical devices for the global cardiac rhythm management, cardiology, cardiac surgery and atrial fibrillation therapy areas and implantable neurostimulation medical devices for the management of chronic pain. We sell our products in more than 100 countries around the world. Our largest geographic markets are the United States, Europe, Japan and Asia Pacific. Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (Neuro). Our principal products in each operating segment are as follows: CRM – tachycardia implantable cardioverter defibrillator systems (ICDs) and bradycardia pacemaker systems (pacemakers); CV – vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF – electrophysiology introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and Neuro – neurostimulation devices. References to “St. Jude Medical,” “St. Jude,” “the Company,” “we,” “us” and “our” are to St. Jude Medical, Inc. and its subsidiaries.

Our industry has undergone significant consolidation in the last decade and is highly competitive. Our strategy requires significant investment in research and development in order to introduce new products. We are focused on improving our operating margins through a variety of techniques, including the production of high quality products, the development of leading edge technology, the enhancement of our existing products and continuous improvement of our manufacturing processes. We expect cost containment pressure on healthcare systems as well as competitive pressures in the industry will continue to place downward pressure on prices for our products.

We participate in several different medical device markets, each of which has its own expected growth rate. A significant portion of our net sales relate to CRM devices – ICDs and pacemakers. Management remains focused on increasing our worldwide CRM market share, as we are one of three principal manufacturers and suppliers in the global CRM market. In order to help accomplish this objective, we have continued to expand our selling organizations and introduce new CRM products. We are also investing in our other three major growth platforms – atrial fibrillation, neuromodulation and cardiovascular, to increase our market share.

During 2008, we expanded our growth programs through the acquisitions of EP MedSystems, Inc. (EP MedSystems), MediGuide Inc. (MediGuide), and Radi Medical Systems AB (Radi Medical Systems). Our EP MedSystems acquisition strengthens our portfolio of products providing visualization, diagnosis and treatment of heart rhythm disorders. The MediGuide acquisition brings a new technology that, with additional research and development efforts, may benefit all of our major growth businesses. MediGuide has been focused on developing a proprietary Medical Positioning System (gMPSTM) technology that provides localization and tracking capability for interventional medical devices. The Radi Medical Systems acquisition expands our reach into two segments of the cardiovascular market in which we previously had not participated: 1) physiological assessment of intravascular pressure during a cardiovascular procedure, which provides physicians additional diagnostic information to better treat their patients and 2) assisted manual compression devices for vascular closure, which helps arrest bleeding of the radial and femoral arteries following an intravascular device procedure.

We utilize a 52/53-week fiscal year ending on the Saturday nearest December 31st. Fiscal year 2008 consisted of 53 weeks and ended on January 3, 2009, and fiscal years 2007 and 2006 consisted of 52 weeks and ended on December 29, 2007 and December 30, 2006, respectively. The additional week in fiscal year 2008 has been reflected in our fourth quarter results.

Net sales in 2008 increased 15% compared to 2007 led by sales growth in ICDs and pacemakers as well as products to treat atrial fibrillation. Foreign currency translation had a favorable impact on net sales of $120.4 million when compared to fiscal year 2007. Compared to 2007, our 2008 ICD net sales grew nearly 18% to $1,534.2 million and our pacemaker net sales grew approximately 10% to $1,167.3 million, both as a result of strong volume growth. Additionally, 2008 AF net sales increased 33%, compared to 2007, to $545.5 million, due to continued market acceptance of device-based procedures to treat the symptoms of atrial fibrillation. Refer to the Segment Performance section for a more detailed discussion of our net sales results by operating segment.

1



Our 2008 net earnings of $384.3 million and diluted net earnings per share of $1.10 declined 31.3% and 30.8%, respectively, compared to 2007 net earnings of $559.0 million and diluted net earnings per share of $1.59. Fiscal year 2008 net earnings included in-process research and development (IPR&D) charges of $319.4 million, after-tax special charges of $72.7 million, after-tax non-profit contribution expenses of $22.2 million and after-tax investment impairment charges of $8.0 million for a combined impact of $422.3 million, or $1.21 per diluted share. Fiscal year 2007 net earnings included after-tax special charges of $77.2 million and an after-tax investment impairment charge of $15.7 million for a combined impact of $92.9 million, or $0.26 per diluted share. Compared to 2007, our net earnings and diluted net earnings per share benefited from increased net sales growth in all of our operating segments with net sales in our CRM and AF operating segments growing 14% and 33%, respectively.

Our 2008 results included $319.4 million of IPR&D charges, or $0.92 per diluted share, primarily related to our MediGuide acquisition, and $72.7 million, or $0.21 per diluted share of after-tax special charges, which consisted of the following: $59.3 million, or $0.17 per diluted share, primarily associated with the impairment of a technology license agreement and the impairment of purchased technology intangible assets related to our 2005 Velocimed LLC (Velocimed) acquisition; $8.7 million, or $0.03 per diluted share, of inventory-related charges; and $4.7 million, or $0.01 per diluted share, related to providing our Merlin™@home wireless patient monitoring system to existing St. Jude Medical CRM patients at no charge. Our 2008 results also included $22.2 million, or $0.06 per diluted share, of after-tax contribution expenses to non-profit organizations including the St. Jude Medical Foundation, and $8.0 million, or $0.02 per diluted share, of after-tax investment impairment charges. Refer to Notes 8 and 9 of the Consolidated Financial Statements for further details of these charges.

Our 2007 results included after-tax special charges of $77.2 million, which consisted of $21.9 million, or $0.06 per diluted share, related to the settlement of a patent litigation matter; $21.4 million, or $0.06 per diluted share, associated with streamlining our operations; $19.0 million, or $0.05 per diluted share, related to discontinued inventory and older model programmer write-offs; and $14.9 million, or $0.04 per diluted share, associated with the impairment of intangible assets related to a terminated distribution agreement. Additionally, our 2007 results included a $15.7 million after-tax investment impairment, or $0.04 per diluted share. Refer to Notes 8 and 9 of the Consolidated Financial Statements for further details of these charges.

We generated $945.6 million of operating cash flows during 2008, compared to $865.6 million of operating cash flows during 2007. We ended the year with $136.4 million of cash and cash equivalents and $1,201.6 million of total debt. We have strong short-term credit ratings, with an A2 rating from Standard & Poor’s and a P2 rating from Moody’s. During the second quarter of 2008, Standard & Poor’s raised our long-term debt rating to A- from BBB+. Additionally, we repurchased 6.7 million shares of our common stock for $300.0 million during 2008 and 23.6 million shares of our common stock for $1.0 billion in 2007.

NEW ACCOUNTING PRONOUNCEMENTS

Information regarding new accounting pronouncements is included in Note 1 to the Consolidated Financial Statements.

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 our accounts receivable allowance for doubtful accounts; estimated useful lives of diagnostic equipment; valuation of IPR&D, other intangible assets and goodwill; income taxes; legal reserves and insurance receivables; and stock-based compensation. We base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, 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 age of accounts receivable, customer financial conditions and credit histories, and current economic conditions. In some developed markets and in many emerging markets, payment 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 $29.0 million at January 3, 2009 and $26.7 million at December 29, 2007.

2



Estimated Useful Lives of Diagnostic Equipment: Diagnostic equipment is recorded at cost and is depreciated using the straight-line method over its estimated useful life of three to five years. Diagnostic equipment primarily consists of programmers that are used by physicians and healthcare professionals to program and analyze data from ICDs and pacemakers. The estimated useful life of this equipment is determined based on our estimates of its usage by the physicians and healthcare professionals, factoring in expected 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 $205.3 million at January 3, 2009 and $189.5 million at December 29, 2007.

Valuation of IPR&D, Other Intangible Assets and Goodwill: When we acquire another company, the purchase price is allocated, as applicable, between IPR&D, other identifiable intangible assets, tangible assets and goodwill. Determining the portion of the purchase price allocated to IPR&D and other intangible assets requires us to make significant estimates.

IPR&D is defined as the value assigned to those projects for which the related products have not yet reached technological feasibility and have no future alternative use. The primary basis for determining the technological feasibility of these projects at the time of acquisition is obtaining regulatory approval to market the underlying products in an applicable geographic region. In accordance with Statement of Financial Accounting Standards (SFAS) No. 141, Business Combinations (SFAS No. 141), we expense the value attributed to these projects in conjunction with the acquisition. In 2008, we recorded IPR&D of $319.4 million. No IPR&D charges were incurred during fiscal years 2007 or 2006. Any IPR&D acquired in a business acquisition in fiscal year 2009 and future periods will be subject to SFAS No. 141 (revised 2007), Business Combinations (SFAS No. 141(R)). Under these new accounting requirements, the fair value of IPR&D will be capitalized as indefinite-lived intangible assets until completion of the IPR&D project or abandonment. Upon completion of the development (generally when regulatory approval to market the product is obtained), acquired IPR&D assets would be amortized over their useful life. If the IPR&D projects are abandoned, the related IPR&D assets would likely be impaired and written down to their remaining fair value, if any. See the New Accounting Pronouncements section that follows for details on the adoption and new accounting provisions of SFAS No. 141(R).

We use the income approach to establish the fair value of IPR&D as of the acquisition date. This approach establishes fair value by estimating the after-tax cash flows attributable to a project over its useful life and then discounting these after-tax cash flows back to a present value. We base our revenue assumptions on estimates of relevant market sizes, expected market growth, and trends in technology as well as anticipated product introductions by competitors. In arriving at the value of the projects, we consider, among other factors, the stage of completion, the complexity of the work completed, the costs incurred, the projected cost of completion, the contribution of core technologies and other acquired assets, the expected introduction date and the estimated useful life of the technology. The discount rate used is determined at the time of acquisition and includes consideration of the assessed risk of the project not being developed to commercial feasibility.

At the time of acquisition, we expect all acquired IPR&D will reach technological feasibility, but there can be no assurance that the commercial viability of these projects will actually be achieved. The nature of the efforts to develop the acquired technologies into commercially viable products consists principally of planning, designing and conducting clinical trials necessary to obtain regulatory approvals. The risks associated with achieving commercialization include, but are not limited to, delay or failure to obtain regulatory approvals to conduct clinical trials, failure of clinical trials, delay or failure to obtain required market clearances, and patent litigation. If commercial viability is not achieved, we would not realize the original estimated financial benefits expected for these projects. We fund all costs to complete IPR&D projects with internally generated cash flows.

The fair value of other identifiable intangible assets is based on detailed valuations using the income approach. Other intangible assets consist of purchased technology and patents, customer lists and relationships, distribution agreements, licenses, trademarks and tradenames, which are amortized using the straight-line method over their estimated useful lives, ranging from 3 to 20 years. We review other intangible assets for impairment as changes in circumstance or the occurrence of events suggest the carrying value may not be recoverable. Other intangible assets, net of accumulated amortization, were $493.5 million at January 3, 2009 and $498.7 million at December 29, 2007.

3



Goodwill represents the excess of the aggregate purchase price over the fair value of net assets, including IPR&D, of the acquired businesses. Goodwill is tested for impairment annually or more frequently if changes in circumstance or the occurrence of events suggest impairment exists. The test for impairment requires us to make several estimates about fair value, most of which are based on projected future cash flows. Our estimates associated with the goodwill impairment tests are considered critical due to the amount of goodwill recorded on our consolidated balance sheets and the judgment required in determining fair value amounts, including projected future cash flows and the use of an appropriate risk-adjusted discount rate. Goodwill was $1,984.6 million at January 3, 2009 and $1,657.3 million at December 29, 2007.

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 financial accounting purposes. These timing differences result in deferred tax assets and liabilities, which are included in our consolidated balance sheet. We also 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 is established. At January 3, 2009, we had $350.5 million of gross deferred tax assets, including net operating loss and tax credit carryforwards that will expire from 2012 to 2025 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, as 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 portion of these earnings to one of our U.S. subsidiaries, including cash maintained by these non-U.S. subsidiaries, additional U.S. tax liabilities would be incurred. It is not practical to estimate the amount of additional U.S. tax liabilities we would incur.

We are subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. We have substantially concluded all U.S. federal income tax matters for all tax years through 2001. Substantially all material foreign, state, and local income tax matters have been concluded for all tax years through 1999. The U.S. Internal Revenue Service (IRS) completed an audit of our 2002-2005 tax returns, and proposed adjustments in its audit report issued in November 2008. We intend to vigorously defend our positions and initiated defense of these adjustments at the IRS appellate level in January 2009. An unfavorable outcome could have a material negative impact on our effective income tax rate in future periods.

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 income tax accruals in accordance with FIN 48 and SFAS No. 109, our accruals represent accounting estimates that are subject to the inherent uncertainties associated with the tax audit process, and therefore include certain contingencies. At January 3, 2009, our liability for unrecognized tax benefits was $82.7 million, and our accrual for interest and penalties was $21.7 million. We believe that any potential tax assessments from the various tax authorities that are not covered by our income tax accruals will not have a material adverse impact on our consolidated financial position or cash flows; however, they may be material to our consolidated earnings of a future period.

Legal Reserves and Insurance Receivables: We operate in an industry that is susceptible to significant product liability and intellectual property claims. As a result, we are involved in a number of legal proceedings, the outcomes of which are not in our complete control and may not be known for extended periods of time. In accordance with SFAS No. 5, Accounting for Contingencies (SFAS No. 5), we record a liability in our consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments where we have assessed that a loss is probable and an amount can be reasonably estimated. 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 related to events that are not known to us at the present time. Our significant legal proceedings are discussed in detail in Note 5 to the Consolidated Financial Statements. While it is not possible to predict the outcome for most of the legal proceedings discussed in Note 5, the costs associated with such proceedings could have a material adverse effect on our consolidated earnings, financial position or cash flows of a future period.

4



We record a receivable from our product liability insurance carriers for amounts expected to be recovered. This includes amounts for legal matters where we have incurred defense costs or where we have recorded a liability for probable and estimable future legal costs, settlements or judgments. We record a receivable for the amount of insurance we expect to recover based on our assessment of the specific insurance policies, the nature of the claim, our experience with similar claims and our assessment of collectability based on our insurers’ financial condition. To the extent our insurance carriers ultimately do not reimburse us, either because such costs are deemed to be outside the scope of our product liability insurance policies or because our insurers may not be able to meet their payment obligations to us, the related losses we incur relating to these unreimbursed costs could have a material adverse effect on our consolidated earnings or cash flows.

Stock-Based Compensation: Effective January 1, 2006, we adopted the provisions of, and account for stock-based compensation in accordance with, SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123(R)). Under the fair value recognition provisions of SFAS No. 123(R), we measure stock-based compensation cost at the grant date based on the fair value of the award and recognize the compensation expense over the requisite service period, which is the vesting period. We elected the modified-prospective method of adopting SFAS No. 123(R), under which prior periods are not retroactively revised. The valuation provisions of SFAS No. 123(R) apply to awards granted after the January 1, 2006 effective date. Estimated stock-based compensation expense for awards granted prior to the effective date that remained unvested on the effective date are recognized over the remaining service period using the compensation cost estimated for SFAS No. 123, Accounting for Stock-Based Compensation pro forma disclosures.

We believe that stock-based compensation aligns the interests of managers and non-employee directors with the interests of shareholders; therefore, we do not currently expect to significantly change our various stock-based compensation programs. See Note 7 to the Consolidated Financial Statements for further information regarding our stock-based compensation programs.

We use the Black-Scholes standard option pricing model (Black-Scholes model) to determine the fair value of stock options and employee stock purchase rights. The determination of the fair value of the awards on the date of grant using the Black-Scholes model is affected by our stock price as well as assumptions of other variables, including projected employee stock option exercise behaviors (expected option life), risk-free interest rate, expected volatility of our stock price in future periods and expected dividend yield.

We analyze historical employee exercise and termination data to estimate the expected life assumption. We believe that historical data currently represents the best estimate of the expected life of a new employee option. We also stratify our employee population based upon distinctive exercise behavior patterns. The risk-free interest rate we use is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected life of the options. In December 2008, we began calculating our expected volatility assumption by equally weighting historical and implied volatility. Previously, we calculated the expected volatility assumption exclusively on the implied volatility of market-traded options. We changed the method of determining expected volatility to take into consideration how future volatility experience over the expected life of the option may differ from short-term volatility experience and thus provide a better estimate of expected volatility over the expected life of employee stock options. The impact of changing the method of determining expected volatility was not material to fiscal year 2008 stock compensation expense. Refer to Note 7 of the Consolidated Financial Statements for further details regarding the change in our expected volatility assumption. Because we do not anticipate paying any cash dividends in the foreseeable future, we use an expected dividend yield of zero. The amount of stock-based compensation expense we recognize during a period is based on the portion of the awards that are ultimately expected to vest. We estimate pre-vesting option forfeitures at the time of grant by analyzing historical data and revise those estimates in subsequent periods if actual forfeitures differ from those estimates.

If factors change and we employ different assumptions for estimating stock-based compensation expense in future periods or if we decide to use a different valuation model, the expense in future periods may differ significantly from what we have recorded in the current period and could materially affect our net earnings and net earnings per share of a future period.

ACQUISITIONS

On July 3, 2008, we completed the acquisition of EP MedSystems for $95.7 million (consisting of $59.0 million in net cash consideration and direct acquisition costs and 0.9 million shares of St. Jude Medical common stock). EP MedSystems had been publicly traded on the NASDAQ Capital Market under the ticker symbol EPMD. EP MedSystems is based in West Berlin, New Jersey and develops, manufactures and markets medical devices for the electrophysiology market which are used for visualization, diagnosis and treatment of heart rhythm disorders. We acquired EP MedSystems to strengthen our portfolio of products used to treat heart rhythm disorders. EP MedSystems has become part of our Atrial Fibrillation division.

5



On December 19, 2008, we completed the acquisition of Radi Medical Systems for $248.9 million in net cash consideration, including direct acquisition costs. Radi Medical Systems is based in Uppsala, Sweden and develops, manufactures and markets products that provide precise measurements of intravascular pressure during a cardiovascular procedure and manual compression systems that arrest bleeding of the femoral and radial arteries following an intravascular medical device procedure. We acquired Radi Medical Systems to accelerate our cardiovascular growth platform in these two segments of the cardiovascular medical device market in which we previously had not participated. Radi Medical Systems has become part of our Cardiovascular division.

On December 22, 2008, we completed the acquisition of MediGuide for $285.2 million in net consideration, which includes future estimated cash consideration payments of approximately $145 million and direct acquisition costs. MediGuide was a development-stage company based in Haifa, Israel and has been focused on developing its Medical Positioning System (gMPSTM) technology for localization and tracking capability for interventional medical devices. We plan to expend additional research and development efforts to achieve technological feasibility for this technology. MediGuide has become part of our Atrial Fibrillation division.

SEGMENT PERFORMANCE

Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (Neuro). The primary products produced by each operating segment are: CRM – ICDs and pacemakers; CV – vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF – electrophysiology introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and Neuro – neurostimulation devices.

We aggregate our four operating segments into two reportable segments based upon their similar operational and economic characteristics: CRM/Neuro and CV/AF. Net sales of our reportable segments include end-customer revenue from the sale of products they each develop and manufacture or distribute. 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 reportable segments. Certain operating expenses managed by our selling and corporate functions, including all stock-based compensation expense, impairment charges and special charges have not been recorded in the individual reportable segments. As a result, reportable segment operating profit is not representative of the operating profit of the products in these reportable segments.

The following table presents net sales and operating profit by reportable segment (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CRM/Neuro

 

CV/AF

 

Other

 

Total

 

Fiscal Year 2008

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,955,603

 

$

1,407,648

 

$

 

$

4,363,251

 

Operating profit

 

 

1,824,023

 

 

736,979

 

 

(1,905,955

)

 

655,047

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year 2007

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,577,975

 

$

1,201,302

 

$

 

$

3,779,277

 

Operating profit

 

 

1,576,439

 

 

579,325

 

 

(1,362,261

)

 

793,503

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year 2006

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,235,128

 

$

1,067,319

 

$

 

$

3,302,447

 

Operating profit

 

 

1,337,479

 

 

502,244

 

 

(1,096,640

)

 

743,083

 

The following discussion of the changes in our net sales is provided by class of similar products within our four operating segments, which is the primary focus of our sales activities.

Cardiac Rhythm Management

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

ICD systems

 

$

1,534,212

 

$

1,304,899

 

$

1,099,906

 

 

17.6

%

 

18.6

%

Pacemaker systems

 

 

1,167,251

 

 

1,063,182

 

 

955,859

 

 

9.8

%

 

11.2

%

 

 

$

2,701,463

 

$

2,368,081

 

$

2,055,765

 

 

14.1

%

 

15.2

%

6



Cardiac Rhythm Management 2008 net sales increased 14% to $2,701.5 million compared to 2007 due to strong volume growth. Foreign currency translation had a $69.0 million favorable impact on 2008 net sales compared to 2007. Net sales of ICDs increased approximately 18% to $1,534.2 million driven by strong volume growth. The volume growth in ICD net sales in 2008 was broad-based across both U.S. and international markets, which reflects our continued market penetration into new customer accounts and strong market demand for our cardiac resynchronization therapy ICDs. In the United States, 2008 ICD net sales of $985.4 million increased 11% over last year. Internationally, 2008 ICD net sales of $548.8 million increased nearly 32% compared to 2007. Foreign currency translation had a $28.8 million favorable impact on international ICD net sales compared to 2007. Pacemaker systems 2008 net sales increased nearly 10% to $1,167.3 million driven by strong volume growth, which was also broad-based across both U.S. and international markets. In the United States, 2008 pacemaker net sales of $521.9 million increased 3% compared to 2007. Internationally, 2008 pacemaker net sales of $645.4 million increased 16% over last year. Foreign currency translation had a $40.2 million favorable impact on international pacemaker net sales in 2008 compared to 2007.

Cardiac Rhythm Management 2007 net sales increased by 15% to $2,368.1 million compared to 2006 due to strong volume growth. Foreign currency translation had a $63.0 million favorable impact on 2007 net sales compared to 2006. Net sales of ICDs increased nearly 19% to $1,304.9 million driven by strong volume growth. The volume growth in ICD net sales in 2007 was broad-based across both U.S. and international markets. In the United States, 2007 ICD net sales of $887.8 million increased 11% over 2006. Internationally, 2007 ICD net sales of $417.1 million increased nearly 38% compared to 2006. Foreign currency translation had a $30.0 million favorable impact on international ICD net sales compared to 2006. Pacemaker systems 2007 net sales increased 11% to nearly $1,063.2 million driven by strong volume growth, which was also broad-based across both U.S. and international markets. In the United States, 2007 pacemaker net sales of $507.9 million increased 9% compared to 2006. Internationally, 2007 pacemaker net sales of $555.3 million increased 13% over 2006. Foreign currency translation had a $33.0 million favorable impact on international pacemaker net sales in 2007 compared to 2006.

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

Vascular closure devices

 

$

367,893

 

$

353,987

 

$

341,259

 

 

3.9

%

 

3.7

%

Heart valve products

 

 

321,534

 

 

290,196

 

 

270,507

 

 

10.8

%

 

7.3

%

Other cardiovascular products

 

 

172,709

 

 

146,447

 

 

129,846

 

 

17.9

%

 

12.8

%

 

 

$

862,136

 

$

790,630

 

$

741,612

 

 

9.0

%

 

6.6

%

Cardiovascular 2008 net sales increased 9% to $862.1 million compared to 2007 driven by increased sales volumes and favorable foreign currency translation impacts, led by both heart valve products and other cardiovascular products. Foreign currency translation had a $34.0 million favorable impact on CV net sales compared to 2007. Net sales of vascular closure devices increased approximately 4% compared to 2007 due to sales volume growth of Angio-Seal™, which continues to be the market share leader in the vascular closure device market. Heart valve net sales increased 11% compared to 2007 due to increased sales volumes for both tissue heart valves and mechanical heart valves. Other cardiovascular products net sales increased approximately 18% compared to last year due to increased sales volumes and favorable foreign currency translation.

Cardiovascular 2007 net sales increased nearly 7% to $790.6 million compared to 2006 driven by strong volume growth for tissue heart valves and favorable product mix for our other cardiovascular products. Foreign currency translation had a $22.4 million favorable impact on CV net sales compared to 2006. Net sales of vascular closure devices increased approximately 4% compared to 2006 due to sales volume growth of Angio-Seal™. Heart valve net sales increased 7% compared to 2006 primarily due to an increase in tissue heart valve sales volumes, driven by market growth, which was partially offset by declines in sales of mechanical heart valves. Other cardiovascular products net sales increased nearly 13% compared to 2006.

Atrial Fibrillation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

Atrial fibrillation products

 

$

545,512

 

$

410,672

 

$

325,707

 

 

32.8

%

 

26.1

%

Atrial Fibrillation 2008 net sales increased approximately 33% to $545.5 million compared to 2007 net sales. The increase in AF net sales was driven by volume growth from continued market acceptance of device-based procedures to treat the symptoms of atrial fibrillation. Our access, diagnosis, visualization and ablation products assist physicians in diagnosing and treating atrial fibrillation and other irregular heart rhythms. Foreign currency translation had a favorable impact on AF net sales of $16.0 million compared to 2007.

7



Atrial Fibrillation 2007 net sales increased 26% to $410.7 million compared to 2006 net sales. The increase in AF net sales was driven by strong volume growth. Foreign currency translation had a favorable impact on AF net sales of approximately $12.3 million compared to 2006.

Neuromodulation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

Neurostimulation devices

 

$

254,140

 

$

209,894

 

$

179,363

 

 

21.1

%

 

17.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Neuromodulation 2008 net sales increased 21% to $254.1 million compared to 2007 net sales. The increase in Neuro net sales was driven by continued growth in the neuromodulation market and strong volume growth driven by new product introductions. Foreign currency translation did not have a significant impact on 2008 net sales.

Neuromodulation 2007 net sales increased 17% to $209.9 million over 2006 net sales of $179.4 million due to sales volume increases in a growing market for neurostimulation devices. Foreign currency translation did not have a significant impact on 2007 net sales.

RESULTS OF OPERATIONS

Net Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

Net sales

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

 

15.5

%

 

14.4

%

Overall, 2008 net sales increased 15% compared to 2007. Net sales growth was favorably impacted by strong volume growth, driven by CRM and AF product sales. Additionally, foreign currency had a $120.4 million, or 3%, favorable impact on net sales, primarily due to the strengthening of both the Euro and Japanese Yen against the U.S. Dollar.

Overall, 2007 net sales increased 14% compared to 2006. Net sales growth was favorably impacted by strong volume growth, driven by CRM and AF product sales. Additionally, foreign currency translation had a $99.6 million, or 3%, favorable impact on net sales, primarily due to the strengthening of the Euro against the U.S. Dollar.

Net sales by geographic location of the customer were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

United States

 

$

2,319,645

 

$

2,107,015

 

$

1,920,623

 

International

 

 

 

 

 

 

 

 

 

 

Europe

 

 

1,152,601

 

 

936,526

 

 

763,526

 

Japan

 

 

387,648

 

 

321,826

 

 

289,716

 

Asia Pacific

 

 

234,073

 

 

192,793

 

 

148,953

 

Other

 

 

269,284

 

 

221,117

 

 

179,629

 

 

 

 

2,043,606

 

 

1,672,262

 

 

1,381,824

 

 

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

Foreign currency translation relating to our international operations can have a significant impact on our operating results from year to year. The two main currencies influencing our operating results are the Euro and the Japanese Yen. As discussed above, foreign currency translation had a $120.4 million favorable impact on 2008 net sales, while the translation impact in 2007 had a $99.6 million favorable impact on net sales. These impacts to net sales are not indicative of the net earnings impact of foreign currency translation due to partially offsetting foreign currency translation impacts on cost of sales and operating expenses.

8



 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Gross profit

 

$

3,192,710

 

$

2,737,683

 

$

2,388,934

 

Percentage of net sales

 

 

73.2

%

 

72.4

%

 

72.3

%

Gross profit for 2008 totaled $3,192.7 million, or 73.2% of net sales, compared with $2,737.7 million, or 72.4% of net sales in 2007. Special charges in 2008 negatively impacted our gross profit by approximately 1.5 percentage points consisting primarily of charges related to the impairment of a technology license agreement, termination costs related to certain raw material purchase contracts, inventory obsolescence charges associated with a terminated distribution agreement and charges related to providing our new remote patient monitoring system to existing St. Jude Medical CRM patients at no charge. Special charges in 2007 negatively impacted our gross profit margin by approximately 1.0 percentage point and were associated with our 2007 restructuring activities. The improvement in our 2008 gross profit percentage as a percent of net sales is due to favorable foreign currency translation and favorable product mix from higher margin products. Refer to Note 8 of the Consolidated Financial Statements for further details of the special charges impacting our 2008 and 2007 gross profit.

Gross profit for 2007 totaled $2,737.7 million, or 72.4% of net sales, compared with $2,388.9 million, or 72.3% of net sales, for 2006. As discussed above, special charges negatively impacted our 2007 gross profit percentage by approximately 1.0 percentage point. The improvement in our 2007 gross profit percentage as a percent of net sales compared to 2006 reflects favorable product mix and increased manufacturing efficiencies, partially offset by increased diagnostic equipment depreciation expense resulting from the rollout of our Merlin™ programmer platform for our ICDs and pacemakers.

Selling, General and Administrative (SG&A) Expense

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Selling, general and administrative expense

 

$

1,636,526

 

$

1,382,466

 

$

1,195,030

 

Percentage of net sales

 

 

37.5

%

 

36.6

%

 

36.2

%

SG&A expense for 2008 totaled $1,636.5 million, or 37.5% of net sales, compared with $1,382.5 million, or 36.6% of net sales in 2007. The increase in SG&A expense as a percent of net sales is primarily due to $35.0 million of contributions to non-profit organizations, including the St. Jude Medical Foundation.

SG&A expense for 2007 totaled $1,382.5 million, or 36.6% of net sales, compared with $1,195.0 million, or 36.2% of net sales in 2006. The increase in SG&A expense as a percent of net sales reflects the full-year impact of investments made in expanding our U.S. selling organization infrastructure and market development programs, which began in the second quarter of 2006.

Research and Development (R&D) Expense

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Research and development expense

 

$

531,799

 

$

476,332

 

$

431,102

 

Percentage of net sales

 

 

12.2

%

 

12.6

%

 

13.1

%

R&D expense in 2008 totaled $531.8 million, or 12.2% of net sales, compared with $476.3 million, or 12.6% of net sales in 2007. While 2008 R&D expense as a percent of net sales decreased compared to 2007, total R&D expense increased over 11% compared to the prior year, reflecting our continuing commitment to fund future long-term growth opportunities. We will continue to balance delivering short-term results with the right investments in long-term growth drivers, and expect that R&D expense as a percentage of net sales will range from 12% to 13% in 2009.

R&D expense in 2007 totaled $476.3 million, or 12.6% of net sales, compared with $431.1 million, or 13.1% of net sales in 2006. While 2007 R&D expense as a percent of net sales decreased compared to 2006, total R&D expense increased over 10% compared to 2006, reflecting our continuing commitment to fund future long-term growth opportunities.

9



Purchased In-Process Research and Development (IPR&D) Charges

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Purchased in-process research and development charges

 

$

319,354

 

$

 

$

 

IPR&D is defined as the value assigned to those projects for which the related products have not yet reached technological feasibility and have no future alternative use. The primary basis for determining the technological feasibility of these projects at the time of acquisition is obtaining regulatory approval to market the underlying products in an applicable geographic region. We expense the value attributed to these projects in conjunction with the related business acquisition or asset purchase.

MediGuide, Inc.: In December 2008, we acquired privately-held MediGuide a development-stage company that has been focused on developing its Medical Positioning System (gMPSTM) technology for localization and tracking capability for interventional medical devices. The acquisition will provide the Company with exclusive rights to use and develop MediGuide’s gMPSTM technology. As MediGuide was a development-stage company, the excess of the purchase price over the fair value of the net assets acquired was allocated on a pro-rata basis to the net assets acquired. Accordingly, the excess purchase price was allocated to IPR&D, the principal asset acquired. At the date of acquisition, $306.2 million of the purchase price was expensed as IPR&D since technological feasibility of the underlying projects had not yet been reached and such technology had no future alternative use. We expect to incur up to approximately $30 million to bring the technology to commercial viability on a worldwide basis within two to three years.

Other: In December 2008, we also made an additional minority investment in a developmental-stage company and, in accordance with step-acquisition accounting treatment under the equity method of accounting, allocated the excess purchase price over the fair value of the investee’s net assets to IPR&D the principal asset acquired. At the additional investment date, $11.6 million of IPR&D was expensed since technological feasibility of the underlying projects had not yet been reached and such technology had no future alternative use. Additionally, we recognized $1.6 million of IPR&D charges related to the purchase of intellectual property in our CRM and CV segments since the related technological feasibility had not yet been reached and such technology had no future alternative use.

Special Charges

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Cost of sales special charges

 

$

64,603

 

$

38,292

 

$

15,108

 

Special charges

 

 

49,984

 

 

85,382

 

 

19,719

 

 

 

$

114,587

 

$

123,674

 

$

34,827

 

Fiscal Year 2008

Impairment Charges: In September 2004, we completed making payments under a technology license agreement and were granted a fully paid-up license that provided access to patents covering technology used in our CRM devices. In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, whenever events or changes in circumstances indicate that a long-lived asset’s carrying amount may not be recoverable, we test the asset for impairment. In 2008, we determined that a large portion of the technology under the license agreement was no longer fully utilized in our products and that certain of the patents under the license were no longer valid based upon recent patent law developments. Based upon these developments and changes in circumstances, we recognized an impairment charge of $43.5 million to cost of sales to write the technology license agreement down to its fair value.

In 2008, we experienced lower than forecasted sales of certain products in the Cardiovascular division associated with our 2005 acquisition of Velocimed. Based upon the recent unfavorable sales performance as well as negative clinical trial results, we reduced the future revenue and cash flow projections relating to these products. Accordingly, we tested the related purchased technology intangible assets for impairment in the fourth quarter of 2008 and recognized a $37.0 million impairment charge to write down the related intangible assets to their remaining fair value. We also recognized other impairment charges of $5.8 million in 2008 primarily related to assets in the Cardiovascular division that will no longer be utilized.

10



In December 2008, we discontinued the use of the Advanced Neuromodulation Systems, Inc. (ANS) tradename. We had acquired ANS in November 2005 and used the related tradename through its discontinuance in December 2008. Accordingly, we wrote off the ANS tradename intangible assets and recognized a $1.7 million impairment charge.

Inventory-related Charges: In 2008 we entered into purchase contracts in the normal course of business for certain raw material commodities that are used in the manufacture of our products. Favorable decreases in commodity prices in the fourth quarter of 2008 resulted in our election to terminate and exit the contracts, paying $10.7 million in termination costs, which was recorded as a special charge in cost of sales.

We also recognized inventory obsolescence charges related to inventory that is not expected to be sold due to the termination of a distribution agreement in Japan. When we elected to terminate the distribution agreement in December 2007, we recorded a $4.0 million special charge in 2007 related to inventory that we estimated would not be sold. We increased this estimate in 2008 and recorded an additional $3.0 million special charge in cost of sales.

Other Charges: In 2008, we launched our MerlinTM @home wireless patient monitoring system and committed to provide this system without charge to our existing St. Jude Medical CRM patients. In connection with the completion of this roll-out in the fourth quarter of 2008, we recorded a $7.4 million special charge in cost of sales to accrue for the related costs. We also recognized $5.5 million of other unrelated costs.

Fiscal Year 2007

Patent Litigation: In June 2007, we settled a patent litigation matter with Guidant Corporation (a subsidiary of Boston Scientific Corporation) and Mirowski Family Ventures, L.L.C. and recorded a special charge of $35.0 million.

Restructuring Activities: In December 2007, management continued its efforts to streamline operations and implemented additional restructuring actions primarily focused at our international locations. As a result, we recorded special charges totaling $29.1 million in 2007 consisting of employee termination costs ($17.9 million) and other costs ($11.2 million). Of the total $29.1 million charge, $5.9 million was recorded in cost of sales. Employee termination costs related to severance and benefit costs for approximately 200 individuals identified for employment termination. These costs were recorded after management determined that such severance and benefits were probable and estimable, in accordance with SFAS No. 112, Employers’ Accounting for Postemployment Benefits. Other costs primarily represented contract termination costs. The majority of actions and related payments for these restructuring activities were completed by January 3, 2009.

Impairment Charges: We recognized impairment charges of $23.7 million related to acquired intangible assets associated with a distribution agreement with a supplier of medical products to our Japanese distribution subsidiary. In December 2007, we provided notice to the supplier that we were terminating the distribution agreement. As a result, we recognized an impairment charge to state the related intangible assets at their remaining fair value. We had acquired the intangible assets as part of our acquisition in Japan of Getz Bros. Co., Ltd. in April 2003. The distribution agreement was terminated in June 2008.

Additionally, in connection with completing our United States roll-out of the Merlin™ programmer platform for our ICDs and pacemakers, we recorded an $11.8 million special charge in cost of sales to write off the remaining carrying value of older model programmer diagnostic equipment. We also recognized $6.0 million of asset write-offs relating to the carrying value of assets that will no longer be utilized, of which $2.5 million was recorded in cost of sales.

Discontinued Inventory: In 2007, we recorded a $14.1 million special charge in cost of sales relating to inventory that would be scrapped in connection with management’s decision to terminate certain product lines in our CV and AF divisions that were redundant with other existing products lines. By eliminating product lines with redundant characteristics, we do not anticipate any material short-term or long-term impact on future revenue or gross profit percentages.

Additionally, in connection with our decision to terminate the distribution agreement in Japan (see Impairment Charges discussed previously), we recorded a $4.0 million special charge in cost of sales to write off the related inventory that will not be sold.

Fiscal Year 2006

Restructuring Activities: During the third quarter of 2006, management performed a review of the organizational structure of our former Cardiac Surgery and Cardiology divisions and our international selling organization. In August 2006, management approved restructuring plans to streamline operations within our former Cardiac Surgery and Cardiology divisions by combining them into one new Cardiovascular division and also implemented changes in our international selling organization to enhance the efficiency and effectiveness of sales and customer service operations in certain international geographies.

11



As a result of these restructuring plans, we recorded special charges totaling $34.8 million in 2006 consisting of employee termination costs ($14.7 million), inventory write-downs ($8.7 million), asset write-downs ($7.3 million) and other exit costs ($4.1 million). Of the total $34.8 million special charge, $15.1 million was recorded in cost of sales. In connection with these restructuring plans, approximately 140 individuals were identified for employment termination. In addition, management discontinued certain product lines and disposed of related assets. We also discontinued the use of the Getz trademarks in Japan, and wrote off the related $4.2 million acquired intangible assets. All actions related to these restructuring activities were completed in 2006 and 2007.

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2008

 

2007

 

2006

 

Interest income

 

$

16,315

 

$

4,374

 

$

9,266

 

Interest expense

 

 

(22,581

)

 

(38,229

)

 

(33,883

)

Other

 

 

(18,040

)

 

(15,343

)

 

2,175

 

Other income (expense), net

 

$

(24,306

)

$

(49,198

)

$

(22,442

)

The favorable change in other income (expense) during 2008 compared to 2007 was the result of lower interest expense driven by lower average outstanding debt balances as well as the full year 2008 benefit of lower interest rates on our outstanding debt balances. The increase in interest income during 2008 was due to higher average invested cash balances compared to 2007. During 2008, we recognized $12.9 million of pre-tax impairment charges as other expense related to a decline in the fair values of certain investments that were deemed to be other-than-temporary. In 2007, we recognized a $25.1 million pre-tax impairment charge as other expense related to our investment in ProRhythm, Inc. (ProRhythm). This 2007 impairment charge was partially offset by a pre-tax gain of $7.9 million recognized as other income related to the sale of our Conor Medical, Inc. common stock investment.

The unfavorable change in other income (expense) during 2007 compared to 2006 was primarily the result of the $25.1 million ProRhythm impairment charge, which was partially offset by the realized pre-tax gain of $7.9 million related to the sale of our Conor Medical, Inc. common stock investment. Interest expense increased during 2007 compared to 2006 driven by higher average debt balances in 2007. During the first quarter of 2007, we borrowed $350.0 million under an interim liquidity facility and issued additional commercial paper to finance the repurchase of approximately $700 million of our common stock. These borrowings were repaid in April 2007 with proceeds from the issuance of $1.2 billion aggregate principal amount of 1.22% Convertible Senior Debentures (1.22% Convertible Debentures). Interest income decreased in 2007 compared to 2006 due to lower average invested cash balances in 2007.

Income Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(as a percent of pre-tax income)

 

2008

 

2007

 

2006

 

Effective tax rate

 

39.1

%

24.9

%

23.9

%

Our effective tax rate was 39.1% in 2008 compared to 24.9% in 2007. Non-deductible IPR&D charges and 2008 special charges and investment impairment charges unfavorably impacted the 2008 effective rate by 11.6 percentage points. In 2007, special charges as well as the ProRhythm investment impairment charge favorably impacted the 2007 effective tax rate by 2.1 percentage points. Refer to Notes 8 and 9 of the Consolidated Financial Statements for further details regarding these 2008 and 2007 charges.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Earnings

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands, except per share amounts)

 

2008

 

2007

 

2006

 

2008 vs. 2007
% Change

 

2007 vs. 2006
% Change

 

Net earnings

 

$

384,327

 

$

559,038

 

$

548,251

 

 

-31.3

%

 

2.0

%

Diluted net earnings per share

 

$

1.10

 

$

1.59

 

$

1.47

 

 

-30.8

%

 

8.2

%

12



Net earnings were $384.3 million in 2008, a 31.3% decrease over 2007 net earnings of $559.0 million. Diluted net earnings per share were $1.10 in 2008, a 30.8% decrease over 2007 diluted net earnings per share of $1.59. Net earnings for 2008 included IPR&D charges of $319.4 million, after-tax special charges of $72.7 million, after-tax contribution expenses of $22.2 million and after-tax investment impairment charges of $8.0 million for a combined impact of $422.3 million, or $1.21 per diluted share. Net earnings for 2007 included after-tax special charges of $77.2 million and an after-tax investment impairment charge of $15.7 million, for a combined impact of $92.9 million, or $0.26 per diluted share. Refer to Notes 8 and 9 of the Consolidated Financial Statements for further details regarding these 2008 and 2007 charges. Compared to 2007, our net earnings and diluted net earnings per share benefited from increased net sales growth in all of our operating segments with net sales in our CRM and AF operating segments growing 14% and 33%, respectively.

Net earnings were $559.0 million in 2007, a 2.0% increase over 2006 net earnings of $548.3 million. Diluted net earnings per share were $1.59 in 2007, an 8.2% increase over 2006 diluted net earnings per share of $1.47. Net earnings for 2007 included after-tax special charges of $77.2 million and the after-tax investment impairment charge of $15.7 million, for a combined impact of $92.9 million, or $0.26 per diluted share. Net earnings for 2006 included after-tax special charges of $22.0 million, or $0.06 per diluted share, related to restructuring activities. Compared to 2006, the increase in net earnings and diluted net earnings per share were driven primarily by net sales growth in our CRM and AF operating segments. Additionally, the relatively larger increase in our diluted net earnings per share compared to our net earnings growth was primarily a result of our common stock repurchases, resulting in lower shares outstanding. From April 2006 through May 2007, we returned $1.7 billion to shareholders in the form of share repurchases.

LIQUIDITY

We believe that our existing cash balances, available borrowing capacity under our commercial paper program and long-term committed credit facility and future cash generated from operations will be sufficient to meet our working capital, capital investment and debt service requirements over the next twelve months and in the foreseeable future thereafter. In the fourth quarter of 2008, we borrowed $500.0 million from our $1.0 billion long-term committed credit facility. We also entered into a 3-year, unsecured term loan totaling $360.0 million and another 3-year, unsecured term loan totaling 8.0 billion Japanese Yen (the equivalent of $88.2 million at January 3, 2009). The proceeds were used to retire our 1.22% Convertible Debentures and fund two acquisitions: Radi Medical Systems and MediGuide. Although we believe that our earnings, cash flows and balance sheet position will permit us to obtain additional debt financing or equity capital, should additional suitable investment opportunities arise, recent disruptions in the global financial markets may adversely impact the availability and cost of capital.

At January 3, 2009, our short-term credit ratings were A2 from Standard & Poor’s and P2 from Moody’s. Our Standard & Poor’s long-term debt rating at January 3, 2009 was A-. The ratings are not a recommendation to buy, sell or hold our securities, may be changed, superseded or withdrawn at any time and should be evaluated independently of any other rating.

At January 3, 2009, a large portion of our cash and cash equivalents was held by our non-U.S. subsidiaries. These funds are only available for use by our U.S. operations if they are repatriated into the United States. The funds repatriated would be subject to additional U.S. taxes upon repatriation; however, it is not practical to estimate the amount of additional U.S. tax liabilities we would incur.

We use two primary measures that focus on accounts receivable and inventory – days sales outstanding (DSO) and days inventory on hand (DIOH). We use DSO as a measure that places emphasis on how quickly we collect our accounts receivable balances from customers. We use DIOH, which can also be expressed as a measure of the estimated number of days of cost of sales on hand, and as a measure that places emphasis on how efficiently we are managing our inventory levels. These measures may not be computed the same as similarly titled measures used by other companies.

Our DSO (ending net accounts receivable divided by average daily sales for the quarter) decreased from 92 days at December 29, 2007 to 88 days at January 3, 2009 primarily as a result of our increased receivable collection efforts during the fourth quarter of 2008 over the prior year period. Our DIOH (ending net inventory divided by average daily cost of sales for the most recent six months) increased from 152 days at December 29, 2007 to 160 days at January 3, 2009. Special charges recorded in 2008 and 2007 cost of sales reduced our January 3, 2009 DIOH and December 29, 2007 DIOH by 19 days and 11 days, respectively. Foreign currency translation impacts and the December acquisition of Radi Medical Systems increased our January 3, 2009 DIOH by 10 days. Taking these DIOH impacts into consideration, our January 3, 2009 DIOH increased 6 days over December 29, 2007. This increase is the result of our inventory levels increasing to support our increased sales growth and recent product launches.

13



A summary of our cash flows from operating, investing and financing activities is provided in the following table (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

Net cash provided by (used in):

 

 

 

 

 

 

 

 

 

 

Operating activities

 

$

945,592

 

$

865,569

 

$

648,811

 

Investing activities

 

 

(871,073

)

 

(306,315

)

 

(325,639

)

Financing activities

 

 

(322,493

)

 

(259,484

)

 

(786,241

)

Effect of currency exchange rate changes on cash and cash equivalents

 

 

(4,677

)

 

9,436

 

 

8,389

 

Net increase (decrease) in cash and cash equivalents

 

$

(252,651

)

$

309,206

 

$

(454,680

)


Cash Flows from Operating Activities
Cash provided by operating activities was $945.6 million for 2008 compared to $865.6 million for 2007 and $648.8 million for 2006. Operating cash flows can fluctuate significantly from period to period due to payment timing differences of working capital accounts such as accounts receivable and accounts payable. Operating cash flows improved during 2008 compared to 2007 and 2006 due to better management of working capital.

Cash Flows from Investing Activities
Cash used in investing activities was $871.1 million in 2008 compared to $306.3 million in 2007 and $325.6 million in 2006. Our purchases of property, plant and equipment, which totaled $343.9 million, $287.2 million, and $267.9 million in 2008, 2007 and 2006, respectively, reflect our continued investment in our product growth platforms currently in place. During 2008, we spent $490.0 million of net cash consideration on acquisitions, with Radi Medical Systems, MediGuide and EP MedSystems being the most significant. Correspondingly, we spent only $12.2 million and $38.8 million in 2007 and 2006, respectively, to acquire various businesses involved in the distribution of our products. During 2007, we also received proceeds of $12.9 million due to liquidating our minority interest in Conor Medical, Inc., as a result of its acquisition by Johnson and Johnson, Inc.

Cash Flows from Financing Activities
Cash used in financing activities was $322.5 million in 2008 compared to $259.5 million in 2007 and $786.2 million in 2006. Our financing cash flows can fluctuate significantly depending upon our liquidity needs and the amount of stock option exercises and the extent of our common stock repurchases. During 2008, we borrowed $500.0 million from our $1.0 billion long-term committed credit facility to fund the repayment of our $1.2 billion 1.22% Convertible Debentures. Additionally, we entered into a 3-year, unsecured term loan totaling $360.0 million and a 3-year, unsecured term loan totaling 8.0 billion Japanese Yen (the equivalent of $88.2 million at January 3, 2009). During 2008, we also used our outstanding cash balances to repurchase $300.0 million of our common stock. Comparatively, during 2007, we repurchased approximately $1.0 billion of our common stock, which was financed through a combination of a portion of the proceeds from the issuance of $1.2 billion of 1.22% Convertible Debentures, proceeds from the issuance of commercial paper and borrowings under an interim liquidity facility. Approximately $700 million of proceeds from the issuance of our 1.22% Convertible Debentures were used to repay commercial paper borrowings and borrowings under an interim liquidity facility. We also used $101.0 million of proceeds from the issuance of our 1.22% Convertible Debentures to purchase a call option to receive shares of our common stock. During 2006, we repurchased $700.0 million of our common stock and funded the payment of $654.5 million of our 2.80% Convertible Senior Debentures due 2035 (2.80% Convertible Debentures), both of which were primarily financed through proceeds from the issuance of commercial paper. Proceeds from stock options exercised and stock issued, inclusive of the related excess tax benefits, provided $215.0 million, $284.7 million and $105.9 million of cash inflows during 2008, 2007 and 2006, respectively. Proceeds from stock options exercised and stock issued can fluctuate significantly based upon, among other things, the amount and exercise price of stock options exercised and the fair market value of our common stock when stock options are exercised.

DEBT AND CREDIT FACILITIES

Total debt decreased to $1,201.6 million at January 3, 2009 from $1,388.0 million at December 29, 2007 primarily due to the maturity of the Company’s $1.2 billion 1.22% Convertible Debentures. The retirement of our 1.22% Convertible Debentures on December 15, 2008 was funded by new borrowings and cash from operations.

14



We have a long-term $1.0 billion committed credit facility used to support our commercial paper program and for general corporate purposes. Borrowings under this facility bear interest at the United States Prime Rate (Prime Rate) or the United States Dollar London InterBank Offered Rate (LIBOR) plus 0.235%, at our election. In the event over half of the facility is drawn upon, an additional five basis points is added to the elected prime or LIBOR rate. Additionally, the interest rate is subject to adjustment in the event of a change in our credit ratings. In October 2008, we borrowed $500.0 million from our $1.0 billion long-term committed credit facility to fund the repayment of our 1.22% Convertible Debentures. There were no outstanding borrowings under this credit facility during fiscal years 2007 or 2006.

Our commercial paper program provides for the issuance of short-term, unsecured commercial paper with maturities up to 270 days. We had outstanding commercial paper borrowings of $19.4 million at January 3, 2009 and no outstanding commercial paper borrowings at December 29, 2007. During 2008 and 2007 we issued commercial paper at weighted average effective interest rates of 1.0% and 5.4%, respectively. Any future commercial paper borrowings would bear interest at the applicable then-current market rates.

In December 2008, we entered into a 3-year, unsecured term loan totaling $360.0 million, which can be used for general corporate purposes or to refinance certain other outstanding borrowings of the Company. These borrowings bear interest at LIBOR plus 2.0%, although we may also elect the Prime Rate plus 1.0%, which is subject to adjustment in the event of a change in our credit ratings. We are required to make quarterly principal payments in the amount of 5% of the original outstanding borrowings. We had the option to make additional borrowings under this term loan, and in January 2009, we elected to borrow an additional $180.0 million resulting in total borrowings of $540.0 million under this 3-year term loan.

In December 2008, we entered into a 3-year, Yen-denominated unsecured term loan in Japan (Yen Term Loan) totaling 8.0 billion Japanese Yen (the equivalent of $88.2 million at January 3, 2009). The borrowings bear interest at the Yen LIBOR plus 2.0%. Interest payments are required on a semi-annual basis and the entire principal balance is due in December 2011. The principal amount recorded on the balance sheet fluctuates based on the effects of foreign currency translation.

During the first quarter of 2007, we had borrowed $350.0 million under an interim liquidity facility to finance a portion of the common stock repurchases made during the first half of 2007. Borrowings under this liquidity facility bore interest at LIBOR plus 0.35%. On April 25, 2007, this facility expired and we repaid the related outstanding borrowings using a portion of the proceeds from the issuance of the 1.22% Convertible Debentures.

In May 2003, we issued 7-year, 1.02% Yen-denominated notes in Japan (Yen Notes) totaling 20.9 billion Yen (the equivalent of $230.1 million at January 3, 2009 and $182.5 million at December 29, 2007). Interest payments are required on a semi-annual basis and the entire principal balance is due in May 2010. The principal amount recorded on our balance sheet fluctuates based on the effects of foreign currency translation.

In April 2007, we issued $1.2 billion aggregate principal amount of 1.22% Convertible Debentures that matured on December 15, 2008. Interest payments related to the 1.22% Convertible Debentures are required on a semi-annual basis. Under certain circumstances, holders had the right to convert their 1.22% Convertible Debentures at an initial conversion rate of 19.2101 shares of our common stock per $1,000 principal amount of the 1.22% Convertible Debentures (equivalent to an initial conversion price of approximately $52.06 per share). Upon conversion, we were required to satisfy up to 100% of the principal amount of the 1.22% Convertible Debentures solely in cash, with any amounts above the principal amount to be satisfied in shares of our common stock, cash or a combination of common stock and cash, at our election. On December 15, 2008, we retired the 1.22% Convertible Debentures for cash, which was primarily funded by borrowings and cash from operations.

In April 2007, we sold warrants for 23.1 million shares of our common stock in a private transaction and received proceeds of $35.0 million. Over a two-month period beginning in April 2009, we may be required to issue shares of our common stock to the counterparty if the average price of our common stock during a defined period exceeds the warrant exercise price of approximately $60.73 per share.

In December 2005, we issued $660.0 million aggregate principal amount of 2.80% Convertible Debentures that mature in December 2035. Interest on the 2.80% Convertible Debentures is payable on a semi-annual basis. Contingent interest of 0.25% is payable in certain circumstances. Holders of the 2.80% Convertible Debentures can require us to repurchase for cash some or all of the 2.80% Convertible Debentures on December 15 in the years 2006, 2008, 2010, 2015, 2020, 2025 and 2030 or upon the occurrence of certain events. In December 2006 and December 2008, holders required us to repurchase $654.5 million and $5.1 million, respectively, of the 2.80% Convertible Debentures for cash. As of January 3, 2009, $0.4 million aggregate principal amount of the 2.80% Convertible Debentures remained outstanding. We have the right to redeem some or all of the 2.80% Convertible Debentures for cash at any time. The 2.80% Convertible Debentures are convertible into less than six thousand shares of our common stock if the price of our common stock exceeds $64.51 per share. The total number of contingently issuable shares that could be issued to satisfy conversion of the remaining $0.4 million aggregate principal amount of the 2.80% Convertible Debentures is not material.

15



Our $1.0 billion committed credit facility, $360.0 million term loan and Yen Notes contain certain operating and financial covenants. Specifically, the credit facility and $360.0 million term loan require that we have a leverage ratio (defined as the ratio of total debt to EBITDA (net earnings before interest, income taxes, depreciation and amortization)) not exceeding 3.0 to 1.0. The Yen Notes require that we have a ratio of total debt to total capitalization not exceeding 55% and a ratio of consolidated EBIT (net earnings before interest and income taxes) to consolidated interest expense of at least 3.0 to 1.0. Under the credit facility, $360.0 million term loan and Yen Notes we also have certain limitations on how we conduct our business, including limitations on additional liens or indebtedness and limitations on certain acquisitions, mergers, investments and dispositions of assets. We were in compliance with all of our debt covenants during fiscal years 2008, 2007 and 2006.

SHARE REPURCHASES

On February 22, 2008, our Board of Directors authorized a share repurchase program of up to $250.0 million of our outstanding common stock. On April 8, 2008, our Board of Directors authorized an additional $50.0 million of share repurchases as part of this share repurchase program. We ultimately completed the repurchases under the program on May 1, 2008. In total, we repurchased 6.7 million shares for $300.0 million at an average repurchase price of $44.51 per share.

On January 25, 2007, our Board of Directors authorized a share repurchase program of up to $1.0 billion of our outstanding common stock. In the first quarter of 2007, we repurchased $700.0 million of our outstanding common stock. We completed the repurchases under the program on May 8, 2007. In total, we repurchased 23.6 million shares for $1.0 billion at an average repurchase price of $42.34 per share.

DIVIDENDS

We did not declare or pay any cash dividends during 2008, 2007 or 2006. We currently intend to retain our earnings for use in the operation and expansion of our business and therefore do not anticipate paying any cash dividends in the foreseeable future.

OFF-BALANCE SHEET ARRANGEMENTS AND CONTRACTUAL OBLIGATIONS

We believe that our off-balance sheet arrangements do not have a material current or anticipated future effect on our consolidated earnings, financial position or cash flows. Our off-balance sheet arrangements principally consist of operating leases for various facilities and equipment, purchase commitments and contingent acquisition commitments.

In the normal course of business, we periodically enter into agreements that require us to indemnify customers or suppliers for specific risks, such as claims for injury or property damage arising out of our products or the negligence of our personnel or claims alleging that our products infringe third-party patents or other intellectual property. In addition, under our bylaws and indemnification agreements we have entered into with our executive officers and directors, we may be required to indemnify our executive officers and directors for losses arising from their conduct in an official capacity on behalf of St. Jude Medical. We may also be required to indemnify officers and directors of certain companies that we have acquired for losses arising from their conduct on behalf of their companies prior to the closing of our acquisition. Our maximum exposure under these indemnification obligations cannot be estimated, and we have not accrued any liabilities within our consolidated financial statements or included any indemnification provisions in our commitments table. Historically, we have not experienced significant losses on these types of indemnifications.

In addition to the amounts shown in the following table, our noncurrent liability for unrecognized tax benefits was $82.7 million as of January 3, 2009, and we are uncertain as to if or when such amounts may be settled. Related to these unrecognized tax benefits, our liability for potential penalties and interest was $21.7 million as of January 3, 2009.

16



A summary of contractual obligations and other minimum commercial commitments as of January 3, 2009 is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Payments Due by Period

 

 

 

Total

 

Less than
1 Year

 

1-3
Years

 

3-5
Years

 

More than
5 Years

 

Contractual obligations related to off-balance sheet arrangements:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

$

95,597

 

$

26,426

 

$

35,691

 

$

22,208

 

$

11,272

 

Purchase commitments (a)

 

 

352,183

 

 

321,151

 

 

31,032

 

 

 

 

 

Contingent consideration payments (b)

 

 

311,695

 

 

152,926

 

 

51,131

 

 

87,555

 

 

20,083

 

Total

 

$

759,475

 

$

500,503

 

$

117,854

 

$

109,763

 

$

31,355

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contractual obligations reflected in the balance sheet:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term debt (c)

 

 

1,175,046

 

 

117,333

 

 

1,057,713

 

 

 

 

 

Total

 

$

1,934,521

 

$

617,836

 

$

1,175,567

 

$

109,763

 

$

31,355

 


 

 

 

 

(a)

These amounts include commitments for inventory purchases and capital expenditures that do not exceed our projected requirements and are in the normal course of business. The purchase commitment amounts do not represent the entire anticipated purchases and capital expenditures in the future, but only those for which we are contractually obligated.

 

(b)

These amounts include contingent commitments to acquire various businesses involved in the distribution of our products and other contingent acquisition consideration payments. In connection with certain acquisitions, we may agree to provide additional consideration payments upon the achievement of certain product development milestones, which may include but are not limited to: successful levels of achievement in clinical trials and certain product regulatory approvals. We may also provide for additional consideration payments to be made upon the achievement of certain levels of future product sales. 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 best estimates of the dates when we expect the milestones and/or contingencies will be met.

 

(c)

These amounts include scheduled interest and principal payments on our long-term debt. See Note 4 to the Consolidated Financial Statements for additional information on our long-term debt obligations.

MARKET RISK

We are exposed to foreign currency exchange rate fluctuations due to transactions denominated primarily in Euros, Japanese Yen, Canadian Dollars, Australian Dollars, Brazilian Reals, British Pounds, and Swedish Kronor. When the U.S. Dollar weakens against foreign currencies, the dollar value of sales denominated in foreign currencies increases. When the U.S. Dollar strengthens against foreign currencies, the dollar value of sales denominated in foreign currencies decreases. 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 $188 million on our 2008 net sales. This amount is not indicative of the hypothetical net earnings impact due to partially offsetting impacts on the related cost of sales and operating expenses in the applicable foreign currencies.

During 2008, we hedged a portion of our foreign currency exchange rate risk through the use of forward exchange contracts. The gains and losses on these contracts offset the losses and gains on the foreign currency exposure being managed. In 2008, we hedged over $400 million of currency exposures primarily related to intercompany receivables and payables arising from intercompany purchases of manufactured products. At January 3, 2009, we did not have a material amount of forward currency exchange contracts outstanding. We do not enter into contracts for trading or speculative purposes. Our policy is to enter into hedging contracts with major financial institutions that have at least an “A” (or equivalent) credit rating. Although we are exposed to credit loss in the event of nonperformance by counterparties on our outstanding derivative contracts, we do not anticipate nonperformance by any of the counterparties. We did not to enter into any hedging contracts during 2007 and 2006. We continue to evaluate our foreign currency exchange rate risk and the different mechanisms for use in managing such risk, including using derivative financial instruments and operational hedges, such as international manufacturing operations. Our derivative financial instruments accounting policy is discussed in detail in Note 1 to the Consolidated Financial Statements.

17



Although we have not entered into any derivative hedging contracts to hedge the net asset exposure of our foreign subsidiaries, we have elected to use natural hedging strategies in certain geographies. We have naturally hedged a portion of our Yen-denominated net asset exposure by issuing long-term Yen-denominated debt.

We are also exposed to fair value risk on our Yen Notes, which have a fixed interest rate of 1.02%. As of January 3, 2009, the fair value of these notes approximated their carrying value. A hypothetical 10% change in interest rates would have an impact of approximately $0.3 million on the fair value of the Yen Notes, which is not material to our consolidated earnings or financial position.

Our remaining debt principally consists of credit facility borrowings, 3-year term loans in both Japan and the United States and commercial paper borrowings, all of which bear interest at variable rates. Because we entered into these borrowing arrangements in December 2008, a hypothetical 10% change in interest rates would not have had a material impact on our 2008 interest expense. Assuming average outstanding borrowings of $1.0 billion during 2009, a hypothetical 10% change in interest rates (based upon a weighted average interest rate of 2.5% at January 3, 2009) would have an impact of approximately $0.5 million on our 2009 interest expense.

We are also exposed to equity market risk on our marketable equity security investments. We hold certain marketable equity securities of emerging technology companies. Our investments in these companies had a fair value of $22.1 million at January 3, 2009, which are subject to the underlying price risk of the public equity markets.

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.

Competition is anticipated to continue to place pressure on pricing and terms, including a trend toward vendor-owned (consignment) inventory at hospitals. Also, healthcare reform is expected to result in further hospital consolidations over time with related pressure on pricing and terms.

The CRM market is highly competitive. Our two principal competitors in these markets are larger than us and have invested substantial amounts in R&D. Rapid technological change in these markets is expected to continue, requiring us to invest heavily in R&D and to effectively market our products.

The cardiovascular market is also highly competitive with numerous competitors. The majority of our sales is generated from our vascular closure devices and heart valve replacement and repair products. We continue to hold the number one market position in the vascular closure device market; however, 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. The cardiovascular market also includes cardiac surgery products such as mechanical heart valves, tissue heart valves and valve repair products, which are also highly competitive. Cardiac surgery therapies continue to shift to tissue valves and repair products from mechanical heart valves.

The atrial fibrillation therapy area is broadening to include multiple therapy methods and treatments which include drugs, percutaneous delivery of diagnostic and ablation catheters, external electrical cardioversion and defibrillation, implantable defibrillators and open-heart surgery. As a result, we have numerous competitors in the emerging atrial fibrillation market. Larger competitors have begun to expand their presence in the atrial fibrillation market by leveraging their cardiac rhythm management capabilities and through acquisitions.

18



The neuromodulation market is one of medical technology’s fastest growing segments. Competitive pressures will increase in the future as our two principal competitors attempt to secure and grow their positions in the neuromodulation market. Other companies are attempting and will attempt in the future to bring new products or therapies into this market. Barriers to entry for new competitors are high, due to a long and expensive product development and regulatory approval process as well as the intellectual property and patent positions existing in the market. However, other larger medical device companies may be able to enter the neuromodulation market by leveraging their existing medical device capabilities, thereby decreasing the time and resources required to enter the market.

We operate 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 us in the future relative to events that are not known to us at the present time. Our product liability insurance coverage is designed to help protect us against a catastrophic claim. Our product liability insurance coverage for the period June 15, 2008 through June 15, 2009 is $350 million, with a $50 million per occurrence deductible or a $100 million deductible if the claims are deemed an integrated occurrence under the policies.

Group purchasing organizations, independent delivery networks and large single accounts, such as the Veterans Administration 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 such an organization could adversely affect our efforts to sell our products to that organization’s hospitals.

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 constitute “forward-looking statements” with respect to the financial condition, results of operations, plans, objectives, new products, future performance and business of St. Jude Medical, Inc. and its subsidiaries. Statements preceded by, followed by or that include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “forecast”, “project,” “believe” or similar expressions are intended to identify some of the forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are included, along with this statement, for purposes of complying with the safe harbor provisions of that Act. These forward-looking statements involve risks and uncertainties. By identifying these statements for you in this manner, we are alerting you to the possibility that 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. Actual results may differ materially from those contemplated by the forward-looking statements due to, among others, the risks and uncertainties discussed in the previous section entitled Off-Balance Sheet Arrangements and Contractual Obligations, Market Risk and Competition and Other Considerations and in Part I, Item 1A, Risk Factors of our Annual Report on Form 10-K as well as the various factors described 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. We believe the most significant factors that could affect our future operations and results are set forth in the list below.

 

 

 

 

1.

Any legislative or administrative reform to the U.S. Medicare or Medicaid systems or international reimbursement systems that significantly reduces reimbursement for procedures using our medical devices or denies coverage for such procedures, as well as adverse decisions relating to our products by administrators of such systems on coverage or reimbursement issues.

 

2.

Assertion, acquisition or grant of key patents by or to others that have the effect of excluding us from market segments or requiring us to pay royalties.

 

3.

Economic factors, including inflation, contraction in capital markets, changes in interest rates, and changes in foreign currency exchange rates.

 

4.

Product introductions by competitors that 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 the development of or preferences for alternative therapies.

 

7.

Safety, performance or efficacy concerns about our 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.

Declining industry-wide sales caused by product recalls or advisories by our competitors that result in loss of physician and/or patient confidence in the safety, performance or efficacy of sophisticated medical devices in general and/or the types of medical devices recalled in particular.

 

9.

Changes in laws, regulations or administrative practices affecting government regulation of our products, such as FDA laws and regulations that increase the time and/or expense of obtaining approval for products or impose additional burdens on the manufacture and sale of medical devices.

 

10.

Regulatory actions arising from concern over Bovine Spongiform Encephalopathy, sometimes referred to as “mad cow disease,” that have the effect of limiting our ability to market products using bovine collagen, such as Angio-Seal™, or products using bovine pericardial material, such as our Bicor® and Epic™ tissue heart valves, or that impose added costs on the procurement of bovine collagen or bovine pericardial material.

19



 

 

 

 

11.

Difficulties obtaining, or the inability to obtain, appropriate levels of product liability insurance or the refusal of our insurance carriers to pay for losses we incur.

 

12.

The ability of our Silzone® product liability insurers to meet their obligations to us.

 

13.

Severe weather or other natural disasters that cause damage to the facilities of our critical suppliers or one or more of our facilities, such as an earthquake affecting our facilities in California or a hurricane affecting our facilities in Puerto Rico.

 

14.

Healthcare industry consolidation leading to demands for price concessions and/or limitations on, or the elimination of, our ability to sell in significant market segments.

 

15.

Adverse developments in investigations and governmental proceedings, including the investigation of business practices in the cardiac rhythm management industry by the U.S. Attorney’s Office in Boston.

 

16.

Adverse developments in litigation, including product liability litigation, patent or other intellectual property litigation or shareholder litigation.

 

17.

Inability to successfully integrate the businesses that we have acquired in recent years and that we plan to acquire.

 

18.

Failure to successfully complete clinical trials for new indications for our products and/or failure to successfully develop markets for such new indications.

 

19.

Changes in accounting rules that adversely affect the characterization of our results of operations, financial position or cash flows.

 

20.

The disruptions in the financial markets and the economic downturn that adversely impact the availability and cost of credit and customer purchasing and payment patterns.

20



Report of Management

Management’s Report on the Financial Statements

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.

Audit Committee Oversight

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 independent directors. The independent registered public accounting firm meets with, and has confidential access to, the Audit Committee to discuss the results of its audit work.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Under the supervision and with the participation of the Company’s management, including the CEO and the CFO, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, the CEO and CFO concluded that our internal control over financial reporting was effective as of January 3, 2009. Ernst & Young LLP, our independent registered public accounting firm, has also audited the effectiveness of the Company’s internal controls over financial reporting as of January 3, 2009 as stated in their report which is included herein.

 

/s/   Daniel J. Starks

 

Daniel J. Starks

Chairman, President and Chief Executive Officer

 

/s/   John C. Heinmiller

 

John C. Heinmiller
Executive Vice President and Chief Financial Officer

21



Report of Independent Registered Public Accounting Firm

The Board of Directors and Shareholders
of St. Jude Medical, Inc.

We have audited St. Jude Medical, Inc.’s internal control over financial reporting as of January 3, 2009, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). St. Jude Medical, Inc.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying report of management entitled Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on St. Jude Medical, Inc.’s internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, St. Jude Medical, Inc. maintained, in all material respects, effective internal control over financial reporting as of January 3, 2009, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of St. Jude Medical, Inc. and subsidiaries as of January 3, 2009 and December 29, 2007, and the related consolidated statements of earnings, shareholders’ equity, and cash flows for each of the three fiscal years in the period ended January 3, 2009, and our report dated February 26, 2009, expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Minneapolis, Minnesota
February 26, 2009

22



Report of Independent Registered Public Accounting Firm

The Board of Directors and Shareholders
of St. Jude Medical, Inc.

We have audited the accompanying consolidated balance sheets of St. Jude Medical, Inc. and subsidiaries as of January 3, 2009 and December 29, 2007, and the related consolidated statements of earnings, shareholders’ equity, and cash flows for each of the three fiscal years in the period ended January 3, 2009. 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 the standards of the Public Company Accounting Oversight Board (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 January 3, 2009 and December 29, 2007, and the consolidated results of their operations and their cash flows for each of the three fiscal years in the period ended January 3, 2009, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), St. Jude Medical Inc.’s internal control over financial reporting as of January 3, 2009, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 26, 2009, expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Minneapolis, Minnesota
February 26, 2009

23



CONSOLIDATED STATEMENTS OF EARNINGS
(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year Ended

 

January 3, 2009

 

December 29, 2007

 

December 30, 2006

 

Net sales

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

Cost of sales:

 

 

 

 

 

 

 

 

 

 

Cost of sales before special charges

 

 

1,105,938

 

 

1,003,302

 

 

898,405

 

Special charges

 

 

64,603

 

 

38,292

 

 

15,108

 

Total cost of sales
 
 
1,170,541
 
 
1,041,594
 
 
913,513
 

Gross profit

 

 

3,192,710

 

 

2,737,683

 

 

2,388,934

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expense

 

 

1,636,526

 

 

1,382,466

 

 

1,195,030

 

Research and development expense

 

 

531,799

 

 

476,332

 

 

431,102

 

Purchased in-process research and development charges

 

 

319,354

 

 

 

 

 

Special charges

 

 

49,984

 

 

85,382

 

 

19,719

 

Operating profit

 

 

655,047

 

 

793,503

 

 

743,083

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

(24,306

)

 

(49,198

)

 

(22,442

)

Earnings before income taxes

 

 

630,741

 

 

744,305

 

 

720,641

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

246,414

 

 

185,267

 

 

172,390

 

 

 

 

 

 

 

 

 

 

 

 

Net earnings

 

$

384,327

 

$

559,038

 

$

548,251

 

 

 

 

 

 

 

 

 

 

 

 

Net earnings per share:

 

 

 

 

 

 

 

 

 

 

Basic

 

$

1.12

 

$

1.63

 

$

1.53

 

Diluted

 

$

1.10

 

$

1.59

 

$

1.47

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

Basic

 

 

342,888

 

 

342,103

 

 

359,252

 

Diluted

 

 

349,722

 

 

352,444

 

 

372,830

 

See notes to the consolidated financial statements.

24



 

CONSOLIDATED BALANCE SHEETS

(in thousands, except share amounts)

 


 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

December 29, 2007

 

ASSETS

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

136,443

 

$

389,094

 

Accounts receivable, less allowances for doubtful accounts

 

 

1,101,258

 

 

1,023,952

 

Inventories

 

 

546,499

 

 

457,734

 

Deferred income taxes, net

 

 

137,042

 

 

110,710

 

Other

 

 

158,821

 

 

146,693

 

Total current assets

 

 

2,080,063

 

 

2,128,183

 

 

 

 

 

 

 

 

 

Property, Plant and Equipment

 

 

 

 

 

 

 

Land, buildings and improvements

 

 

386,519

 

 

300,360

 

Machinery and equipment

 

 

918,254

 

 

760,061

 

Diagnostic equipment

 

 

371,206

 

 

338,983

 

Property, plant and equipment at cost

 

 

1,675,979

 

 

1,399,404

 

Less accumulated depreciation

 

 

(695,803

)

 

(622,609

)

Net property, plant and equipment

 

 

980,176

 

 

776,795

 

 

 

 

 

 

 

 

 

Other Assets

 

 

 

 

 

 

 

Goodwill

 

 

1,984,566

 

 

1,657,313

 

Other intangible assets, net

 

 

493,535

 

 

498,700

 

Other

 

 

184,164

 

 

268,413

 

Total other assets

 

 

2,662,265

 

 

2,424,426

 

TOTAL ASSETS

 

$

5,722,504

 

$

5,329,404

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

Current portion of long-term debt

 

$

75,518

 

$

1,205,498

 

Accounts payable

 

 

238,310

 

 

188,210

 

Income taxes payable

 

 

17,608

 

 

16,458

 

Accrued expenses

 

 

 

 

 

 

 

Employee compensation and related benefits

 

 

297,287

 

 

261,833

 

Other

 

 

399,801

 

 

177,230

 

Total current liabilities

 

 

1,028,524

 

 

1,849,229

 

 

 

 

 

 

 

 

 

Long-term debt

 

 

1,126,084

 

 

182,493

 

Deferred income taxes, net

 

 

112,231

 

 

107,011

 

Other liabilities

 

 

219,759

 

 

262,661

 

Total liabilities

 

 

2,486,598

 

 

2,401,394

 

 

 

 

 

 

 

 

 

Commitments and Contingencies (Notes 2 and 5)

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ Equity

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

Common stock (345,332,272 and 342,846,963 shares issued and outstanding at January 3, 2009 and December 29, 2007, respectively)

 

 

34,533

 

 

34,285

 

Additional paid-in capital

 

 

219,041

 

 

193,662

 

Retained earnings

 

 

2,977,630

 

 

2,600,905

 

Accumulated other comprehensive income (loss):

 

 

 

 

 

 

 

Cumulative translation adjustment

 

 

(1,023

)

 

86,754

 

Unrealized gain on available-for-sale securities

 

 

6,136

 

 

12,404

 

Unrealized loss on derivative financial instruments

 

 

(411

)

 

 

Total shareholders’ equity

 

 

3,235,906

 

 

2,928,010

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

5,722,504

 

$

5,329,404

 

See notes to the consolidated financial statements.

25



CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional
Paid-In
Capital

 

 

 

 

 

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

Total
Shareholders’
Equity

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

Amount

 

 

Unearned
Compensation

 

Retained
Earnings

 

 

 

Balance at December 31, 2005

 

367,904,418

 

 

36,790

 

 

514,360

 

 

(5,641

)

 

2,345,311

 

 

(7,775

)

 

2,883,045

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net earnings

 

 

 

 

 

 

 

 

 

 

 

 

 

548,251

 

 

 

 

 

548,251

 

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities, net of taxes of $929

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,630

 

 

1,630

 

Foreign currency translation adjustment, net of taxes of $(2,179)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

52,474

 

 

52,474

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

54,104

 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

602,355

 

Repurchases of common stock

 

(18,579,390

)

 

(1,858

)

 

(591,672

)

 

 

 

 

(106,470

)

 

 

 

 

(700,000

)

Stock-based compensation

 

 

 

 

 

 

 

70,402

 

 

 

 

 

 

 

 

 

 

 

70,402

 

Reclassification upon adoption of SFAS
123(R)

 

 

 

 

 

 

 

(5,641

)

 

5,641

 

 

 

 

 

 

 

 

 

Common stock issued under stock plans and other, net

 

4,606,972

 

 

461

 

 

76,901

 

 

 

 

 

 

 

 

 

 

 

77,362

 

Tax benefit from stock plans

 

 

 

 

 

 

 

35,823

 

 

 

 

 

 

 

 

 

 

 

35,823

 

Balance at December 30, 2006

 

353,932,000

 

 

35,393

 

 

100,173

 

 

 

 

2,787,092

 

 

46,329

 

 

2,968,987

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net earnings

 

 

 

 

 

 

 

 

 

 

 

 

 

559,038

 

 

 

 

 

559,038

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities, net of taxes of $(3,343)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,766

)

 

(5,766

)

Reclassification of realized gain to net earnings, net of taxes of $3,013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,916

)

 

(4,916

)

Foreign currency translation adjustment, net of taxes of $(4,227)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

63,511

 

 

63,511

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

52,829

 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

611,867

 

Repurchases of common stock

 

(23,619,400

)

 

(2,361

)

 

(243,739

)

 

 

 

 

(753,767

)

 

 

 

 

(999,867

)

Stock-based compensation

 

 

 

 

 

 

 

54,540

 

 

 

 

 

 

 

 

 

 

 

54,540

 

Common stock issued under stock plans and other, net

 

12,534,363

 

 

1,253

 

 

185,564

 

 

 

 

 

 

 

 

 

 

 

186,817

 

Tax benefit from stock plans

 

 

 

 

 

 

 

125,234

 

 

 

 

 

 

 

 

 

 

 

125,234

 

Cumulative effect adjustment to retained earnings related to the adoption of FIN 48

 

 

 

 

 

 

 

 

 

 

 

 

 

8,542

 

 

 

 

 

8,542

 

Purchase of call options, net of taxes of $(37,890)

 

 

 

 

 

 

 

(63,150

)

 

 

 

 

 

 

 

 

 

 

(63,150

)

Proceeds from the sale of warrants

 

 

 

 

 

 

 

35,040

 

 

 

 

 

 

 

 

 

 

 

35,040

 

Balance at December 29, 2007

 

342,846,963

 

 

34,285

 

 

193,662

 

 

 

 

2,600,905

 

 

99,158

 

 

2,928,010

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net earnings

 

 

 

 

 

 

 

 

 

 

 

 

 

384,327

 

 

 

 

 

384,327

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities, net of taxes of $(3,696)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,268

)

 

(6,268

)

Unrealized loss on derivative financial instruments, net of taxes of $(247)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(411

)

 

(411

)

Foreign currency translation adjustment, net of taxes of $(4,281)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(87,777

)

 

(87,777

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(94,456

)

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

289,871

 

Repurchases of common stock

 

(6,736,888

)

 

(674

)

 

(291,724

)

 

 

 

 

(7,602

)

 

 

 

 

(300,000

)

Stock-based compensation

 

 

 

 

 

 

 

52,935

 

 

 

 

 

 

 

 

 

 

 

52,935

 

Common stock issued under stock plans and other, net

 

8,319,532

 

 

832

 

 

165,182

 

 

 

 

 

 

 

 

 

 

 

166,014

 

Common stock issued in connection with acquisition

 

902,665

 

 

90

 

 

36,621

 

 

 

 

 

 

 

 

 

 

 

36,711

 

Tax benefit from stock plans

 

 

 

 

 

 

 

62,365

 

 

 

 

 

 

 

 

 

 

 

62,365

 

Balance at January 3, 2009

 

345,332,272

 

$

34,533

 

$

219,041

 

$

 

$

2,977,630

 

$

4,702

 

$

3,235,906

 

See notes to the consolidated financial statements.

26



CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year Ended

 

January 3, 2009

 

December 29, 2007

 

December 30, 2006

 

OPERATING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

Net earnings

 

$

384,327

 

$

559,038

 

$

548,251

 

Adjustments to reconcile net earnings to net cash from operating activities:

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

132,308

 

 

121,688

 

 

94,002

 

Amortization

 

 

70,120

 

 

75,977

 

 

72,810

 

Gain on sale of investment

 

 

 

 

(7,929

)

 

 

Stock-based compensation

 

 

52,935

 

 

54,540

 

 

70,402

 

Excess tax benefits from stock-based compensation

 

 

(48,995

)

 

(97,921

)

 

(28,577

)

Investment impairment charges

 

 

12,902

 

 

25,094

 

 

 

Purchased in-process research and development charges

 

 

319,354

 

 

 

 

 

Special charges

 

 

114,587

 

 

88,674

 

 

34,827

 

Deferred income taxes

 

 

(31,698

)

 

(6,229

)

 

(10,927

)

Changes in operating assets and liabilities, net of business acquisitions:

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(92,301

)

 

(91,964

)

 

(54,945

)

Inventories

 

 

(87,533

)

 

(13,660

)

 

(77,444

)

Other current assets

 

 

(20,032

)

 

(5,301

)

 

(18,329

)

Accounts payable and accrued expenses

 

 

55,418

 

 

20,815

 

 

(29,175

)

Income taxes payable

 

 

84,200

 

 

142,747

 

 

47,916

 

Net cash provided by operating activities

 

 

945,592

 

 

865,569

 

 

648,811

 

 

 

 

 

 

 

 

 

 

 

 

INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

Purchases of property, plant and equipment

 

 

(343,912

)

 

(287,157

)

 

(267,896

)

Proceeds from the sale of investments

 

 

 

 

12,929

 

 

 

Business acquisition payments, net of cash acquired

 

 

(490,027

)

 

(12,238

)

 

(38,797

)

Other investing activities, net

 

 

(37,134

)

 

(19,849

)

 

(18,946

)

Net cash used in investing activities

 

 

(871,073

)

 

(306,315

)

 

(325,639

)

 

 

 

 

 

 

 

 

 

 

 

FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options and stock issued

 

 

166,014

 

 

186,817

 

 

77,362

 

Excess tax benefits from stock-based compensation

 

 

48,995

 

 

97,921

 

 

28,577

 

Common stock repurchased, including related costs

 

 

(300,000

)

 

(999,867

)

 

(700,000

)

Borrowings under debt facilities

 

 

967,622

 

 

8,045,869

 

 

4,949,101

 

Payments under debt facilities

 

 

 

 

(8,724,224

)

 

(4,486,779

)

Issuance (repayment) of convertible debentures

 

 

(1,205,124

)

 

1,200,000

 

 

(654,502

)

Purchase of call options

 

 

 

 

(101,040

)

 

 

Proceeds from the sale of warrants

 

 

 

 

35,040

 

 

 

Net cash used in financing activities

 

 

(322,493

)

 

(259,484

)

 

(786,241

)

 

 

 

 

 

 

 

 

 

 

 

Effect of currency exchange rate changes on cash and cash equivalents

 

 

(4,677

)

 

9,436

 

 

8,389

 

Net increase (decrease) in cash and cash equivalents

 

 

(252,651

)

 

309,206

 

 

(454,680

)

Cash and cash equivalents at beginning of year

 

 

389,094

 

 

79,888

 

 

534,568

 

Cash and cash equivalents at end of year

 

$

136,443

 

$

389,094

 

$

79,888

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental Cash Flow Information

 

 

 

 

 

 

 

 

 

 

Cash paid during the year for:

 

 

 

 

 

 

 

 

 

 

Interest

 

$

21,712

 

$

32,686

 

$

39,746

 

Income taxes

 

$

211,860

 

$

100,599

 

$

140,799

 

Noncash investing activities:

 

 

 

 

 

 

 

 

 

 

Issuance of stock in connection with EP MedSystms, Inc. acquisition

 

$

36,711

 

$

 

$

 

See notes to the consolidated financial statements.

27



Notes to the Consolidated Financial Statements

NOTE 1 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Company Overview: St. Jude Medical, Inc., together with its subsidiaries (St. Jude Medical or the Company) develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management, cardiology, cardiac surgery and atrial fibrillation therapy areas and implantable neurostimulation devices for the management of chronic pain. The Company’s four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF) and Neuromodulation (Neuro). At the beginning of its 2007 fiscal year, the Company combined its former Cardiac Surgery and Cardiology operating segments to form the CV operating segment which focuses on both the cardiology and cardiac surgery therapy areas. The Company’s principal products in each operating segment are as follows: CRM – tachycardia implantable cardioverter defibrillator systems (ICDs) and bradycardia pacemaker systems (pacemakers); CV – vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF – electrophysiology (EP) introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and Neuro – neurostimulation devices. 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, Japan and Asia Pacific.

Principles of Consolidation: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been eliminated in consolidation.

Fiscal Year: The Company utilizes a 52/53-week fiscal year ending on the Saturday nearest December 31st. Fiscal year 2008 consisted of 53 weeks and ended on January 3, 2009, and fiscal years 2007 and 2006 consisted of 52 weeks and ended on December 29, 2007 and December 30, 2006, respectively. The additional week in fiscal year 2008 has been reflected in the Company’s fourth quarter.

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 value. The Company’s cash equivalents include bank certificates of deposit, money market funds and instruments and commercial paper investments. The Company performs periodic evaluations of the relative credit 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 that are classified as available-for-sale securities and investments in mutual funds that are classified as trading securities. On the balance sheet, available-for-sale securities and trading securities are classified as other current assets and other assets, respectively.

Available-for-sale securities are recorded at fair value based upon quoted market prices. Unrealized gains and losses, net of related incomes taxes, are recorded in accumulated other comprehensive income in shareholders’ equity. The following table summarizes the components of the balance of the Company’s available-for-sale securities (in thousands):

 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

December 29, 2007

 

Adjusted cost

 

$

12,187

 

$

11,920

 

Gross unrealized gains

 

 

9,944

 

 

20,553

 

Gross unrealized losses

 

 

(66

)

 

(54

)

Fair value

 

$

22,065

 

$

32,419

 

Realized gains (losses) from the sale of available-for-sale securities are recorded to other income (expense) and are computed using the specific identification method. Upon the sale of an available-for-sale security, the unrealized gain (loss) is reclassified out of other accumulated comprehensive income and reflected as a realized gain (loss) in net earnings. In 2007, the Company sold an available-for-sale security, recognizing a realized after-tax gain of $4.9 million. The total pre-tax gain of $7.9 million was recognized as other income (see Note 9). There were no realized gains (losses) from the sale of available-for-sale securities in 2008 or 2006. When the fair value of an available-for-sale security falls below its original cost and the Company determines that the corresponding unrealized loss is other-than-temporary, the Company recognizes an impairment loss to net earnings in the period the determination is made. In 2008, the Company recognized a pre-tax impairment charge of $0.7 million to other expense (see Note 9) related to a decline in the fair value of an available-for-sale security that was deemed other-than-temporary. No available-for-sale security impairment losses were recognized during fiscal years 2007 or 2006.

28



The Company’s investments in mutual funds are recorded at fair market value based upon quoted market prices and are held in a rabbi trust, which is not available for general corporate purposes and is subject to creditor claims in the event of insolvency. These investments are specifically designated as available to the Company solely for the purpose of paying benefits under the Company’s deferred compensation plan (see Note 11). The fair value of these investments totaled approximately $108 million at January 3, 2009 and approximately $139 million at December 29, 2007.

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 $29.0 million at January 3, 2009 and $26.7 million at December 29, 2007.

Inventories: Inventories are stated at the lower of cost or market with cost determined using the first-in, first-out method. Inventories consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

December 29, 2007

 

Finished goods

 

$

398,452

 

$

338,195

 

Work in process

 

 

39,143

 

 

32,889

 

Raw materials

 

 

108,904

 

 

86,650

 

 

 

$

546,499

 

$

457,734

 

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 three to five years for diagnostic equipment. Diagnostic equipment primarily consists of programmers that are used by physicians and healthcare professionals to program and analyze data from ICDs and pacemakers. The estimated useful lives of this equipment are based on anticipated usage by physicians and healthcare professionals and the timing and impact of expected new technology platforms and rollouts by the Company. To the extent 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 $205.3 million and $189.5 million at January 3, 2009 and December 29, 2007, respectively. Property, plant and equipment are depreciated using accelerated methods 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. Other intangible assets consist of purchased technology and patents, customer lists and relationships, trademarks and tradenames, licenses and distribution agreements, which are amortized on a straight-line basis using lives ranging from 3 to 20 years.

Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible Assets (SFAS No. 142), requires that goodwill for each reporting unit be reviewed for impairment at least annually. The Company has four reporting units at January 3, 2009, consisting of its four operating segments (see Note 13). The Company tests goodwill for impairment using the two-step process prescribed in SFAS No. 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 complete step 2 in order to measure the impairment loss. In step 2, the Company calculates 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. During the fourth quarters of 2008, 2007 and 2006, the Company completed its annual goodwill impairment review and identified no impairment associated with the carrying values of goodwill.

29



The Company 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. In assessing fair value, the Company generally utilizes present value cash flow calculations using an appropriate risk-adjusted discount rate. In 2008, the Company recorded a $37.0 million impairment charge to write down purchased technology intangible assets associated with its 2005 Velocimed LLC (Velocimed) acquisition and a $1.7 million impairment charge to write off Advanced Neuromodulation Systems, Inc. (ANS) tradename intangible assets. In 2007, the Company recorded a $23.7 million impairment charge to write down intangible assets associated with a distribution agreement. Refer to Note 8 for further detail regarding these impairment charges.

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 fiscal years 2008 and 2007 were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

Balance at beginning of year

 

$

16,691

 

$

12,835

 

Warranty expense recognized

 

 

1,515

 

 

6,412

 

Warranty credits issued

 

 

(2,482

)

 

(2,556

)

Balance at end of year

 

$

15,724

 

$

16,691

 

Litigation: The Company accrues a liability for costs related to claims, including future legal costs, settlements and judgments where it has assessed that a loss is probable and an amount can be reasonably estimated. The Company records a receivable from its product liability insurance carriers for amounts expected to be recovered.

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 collectability is reasonably assured. A portion of the Company’s inventory is held by field sales representatives or consigned at hospitals. Revenue is recognized at the time the Company is notified that the inventory has been implanted or used by the customer. 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 offers sales rebates and discounts to certain customers. The Company records such rebates and discounts as a reduction of net sales in the same period revenue is recognized. The Company estimates rebates based on sales terms and historical experience.

Research and Development: Research and development costs are expensed as incurred.

Purchased In-Process Research and Development (IPR&D): When the Company acquires another entity, the purchase price is allocated, as applicable, between IPR&D, other identifiable intangible assets, tangible assets and goodwill. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates.

The Company’s policy defines IPR&D as the value assigned to those projects for which the related products have not yet reached technological feasibility and have no future alternative use. The primary basis for determining the technological feasibility of these projects is obtaining regulatory approval to market the underlying products in an applicable geographic region. In accordance with Statement of Financial Accounting Standards (SFAS) No. 141, Business Combinations (SFAS No. 141), the value attributed to those projects is expensed in conjunction with the acquisition. The Company recorded IPR&D charges of $319.4 million in 2008. Any IPR&D acquired in a business acquisition in fiscal year 2009 and future periods will be subject to SFAS No. 141 (revised 2007), Business Combinations (SFAS No. 141(R)). Under these new accounting requirements, the fair value of IPR&D will be capitalized as indefinite-lived intangible assets until completion of the IPR&D project or abandonment. Upon completion of the development (generally when regulatory approval to market the product is obtained), acquired IPR&D assets would be amortized over their useful life. If the IPR&D projects are abandoned, the related IPR&D assets would likely be impaired and written down to their remaining fair value, if any. See the New Accounting Pronouncements section that follows for details on the adoption and new accounting provisions of SFAS No. 141(R).

30



The Company uses the income approach to establish the fair value of IPR&D as of the acquisition date. This approach establishes fair value by estimating the after-tax cash flows attributable to a project over its useful life and then discounting these after-tax cash flows back to a present value. The Company bases its revenue assumptions on estimates of relevant market sizes, expected market growth, and trends in technology as well as anticipated product introductions by competitors. In arriving at the value of the projects, the Company considers, among other factors, the stage of completion, the complexity of the work completed, the costs incurred, the projected cost of completion, the contribution of core technologies and other acquired assets, the expected introduction date and the estimated useful life of the technology. The discount rate used is determined at the time of acquisition and includes consideration of the assessed risk of the project not being developed to commercial feasibility. The Company believes that the IPR&D amounts recorded represent the fair value at the date of acquisition and do not exceed the amount a third party would pay for the projects.

Stock-Based Compensation: Effective January 1, 2006, the Company adopted the provisions of, and accounts for stock-based compensation in accordance with, SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123(R)). The Company elected the modified-prospective method of adopting SFAS No. 123(R), under which prior periods are not retroactively revised. Under the fair value recognition provisions of SFAS No. 123(R), the Company measures stock-based compensation cost at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is the vesting period. For the Company, the valuation provisions of SFAS No. 123(R) apply to awards granted after the January 1, 2006 effective date. Stock-based compensation expense for awards granted prior to the effective date but that remain unvested on the effective date is being recognized over the remaining service period using the compensation cost estimated for the SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No. 123) pro forma disclosures.

Prior to adopting SFAS No. 123(R) on January 1, 2006, the Company used a graded attribution method, as described in Financial Accounting Standards Board (FASB) Interpretation No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans, to recognize its pro forma stock-based compensation expense. Unrecognized stock-based compensation expense for awards granted prior to the adoption of SFAS No. 123(R) is recognized under the graded attribution method. Stock-based compensation expense for awards granted after the adoption of SFAS No. 123(R) is recognized under a straight-line attribution method.

The amount of stock-based compensation expense recognized during a period is based on the portion of the awards that are ultimately expected to vest. The Company estimates pre-vesting option forfeitures at the time of grant by analyzing historical data and revises those estimates in subsequent periods if actual forfeitures differ from those estimates. Ultimately, the total expense recognized over the vesting period will only be for those awards that vest. The Company’s awards are not eligible to vest early in the event of retirement, however, the majority of the Company’s awards vest early in the event of a change in control.

As a result of the adoption of SFAS No. 123(R), the Company’s earnings before income taxes for fiscal years 2008, 2007 and 2006 were reduced by $52.9 million, $54.5 million and $70.4 million, respectively, and the Company’s net earnings for the same periods were reduced by $37.8 million, $38.4 million and $49.4 million, respectively. Basic net earnings per share for fiscal years 2008, 2007 and 2006 were reduced by $0.11, $0.11 and $0.14, respectively, and the Company’s diluted net earnings per share for the same periods were reduced by $0.11, $0.11 and $0.13, respectively.

The adoption of SFAS No. 123(R) also had a material impact on the Company’s presentation of its consolidated statement of cash flows. Prior to the adoption of SFAS No. 123(R), stock option exercise tax benefits in excess of tax benefits from recognized stock-based compensation expense were reported as operating cash flows. Under SFAS No. 123(R), such excess tax benefits are reported as financing cash flows. Although total cash flows under SFAS No. 123(R) remain unchanged from what would have been reported under prior accounting standards, net operating cash flows are reduced and net financing cash flows are increased due to the adoption of SFAS No. 123(R). For fiscal years 2008, 2007 and 2006, there were excess tax benefits of $49.0 million, $97.9 million and $28.6 million, respectively, which were required to be classified as operating cash outflows and financing cash inflows.

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.

31



The following table sets forth the computation of basic and diluted net earnings per share for fiscal years 2008, 2007 and 2006 (in thousands, except per share amounts):

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

Numerator:

 

 

 

 

 

 

 

 

 

 

Net earnings

 

$

384,327

 

$

559,038

 

$

548,251

 

 

Denominator:

 

 

 

 

 

 

 

 

 

 

Basic-weighted average shares outstanding

 

 

342,888

 

 

342,103

 

 

359,252

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

 

Employee stock options

 

 

6,765

 

 

10,249

 

 

13,481

 

Restricted stock

 

 

69

 

 

92

 

 

97

 

Diluted-weighted average shares outstanding

 

 

349,722

 

 

352,444

 

 

372,830

 

Basic net earnings per share

 

$

1.12

 

$

1.63

 

$

1.53

 

Diluted net earnings per share

 

$

1.10

 

$

1.59

 

$

1.47

 

Approximately 15.0 million, 12.0 million and 13.9 million shares of common stock subject to employee stock options and restricted stock were excluded from the diluted net earnings per share computation because they were not dilutive during fiscal years 2008, 2007 and 2006, respectively.

Diluted weighted average shares outstanding have also not been adjusted for the warrants the Company sold in April 2007. The potentially dilutive common shares to be issued under the warrants would only be included in diluted weighted average shares outstanding if the Company’s average stock price was greater than the warrant exercise price of $60.73. The dilutive impact would be equal to the number of shares needed to satisfy the intrinsic value of the warrants, assuming exercise.

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 accumulated other comprehensive income. Foreign currency transaction gains and losses are included in other income (expense).

Derivative Financial Instruments: The Company follows the provisions of SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS No. 133), as amended, in accounting for derivative instruments and hedging activities. SFAS No. 133 requires all derivative financial instruments to be recognized on the balance sheet at fair value. Changes in the fair value of derivatives are recognized in net earnings or other comprehensive income depending on whether the derivative is designated as part of a qualifying hedging transaction under SFAS No. 133.

The Company uses forward exchange contracts to manage foreign currency exposures related to intercompany receivables and payables arising from intercompany purchases of manufactured products. These forward contracts are not designated as hedges and therefore, the changes in the fair values of these derivatives are recognized in net earnings and classified in other income (expense). The gains and losses on these contracts largely offset the losses or gains on the foreign currency exposures being managed. The amount of forward exchange contracts outstanding at January 3, 2009 and the related fair value was not material.

In 2008, the Company entered into an interest rate swap contract to convert the $400.0 million of variable-rate borrowings under the Company’s long-term committed credit facility into fixed-rate borrowings. The Company designated this interest rate swap as a cash flow hedge under SFAS No. 133. At January 3, 2009, the Company recognized an unrealized after-tax loss of $0.4 million in other comprehensive income to recognize the fair value of this interest rate swap. Payments made or received under this interest rate swap contract are recorded to interest expense. The related net payments made in 2008 were not material.

New Accounting Pronouncements: The Company adopted the required provisions of SFAS No. 157, Fair Value Measurements (SFAS No. 157) at the beginning of fiscal year 2008 (see Note 12), resulting in no impact to the Company’s consolidated financial statements. SFAS No. 157 establishes a framework for measuring fair value, clarifies the definition of fair value and expands disclosures about fair-value measurements. In general, SFAS No. 157 applies to fair value measurements that are already required or permitted by other accounting standards and is expected to increase the consistency of those measurements. SFAS No. 157, as issued, was effective for fiscal years beginning after November 15, 2007. In February 2008, the FASB issued FASB Staff Position (FSP) SFAS No. 157-2, Effective Date of FASB Statement No. 157 (FSP SFAS No. 157-2) which deferred the effective date of SFAS No. 157 for one year for certain nonfinancial assets and nonfinancial liabilities. The Company adopted the remaining provisions of SFAS No. 157 at the beginning of fiscal year 2009, which did not result in a material impact to the Company’s financial statements.

32



In December 2007, the FASB issued SFAS No. 141(R), which amends SFAS No. 141and provides revised guidance for recognizing and measuring identifiable assets and goodwill acquired, liabilities assumed and any noncontrolling interest in the acquiree. Some of the revised guidance of SFAS No. 141(R) includes initial capitalization of acquired IPR&D, expensing transaction costs, expensing acquired restructuring costs and recording contingent consideration payments at fair value with subsequent adjustments recorded to net earnings. It also provides expanded disclosure requirements to enable users of the financial statements to evaluate the nature and financial statement effects of the business combination. SFAS No. 141(R) is effective for fiscal years beginning on or after December 15, 2008 and will be applied prospectively to business combinations that are consummated after adoption of SFAS No. 141(R). The Company adopted SFAS No. 141(R) at the beginning of fiscal year 2009, and any acquisitions made by the Company in 2009 and future periods will be subject to this new accounting guidance.

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities (SFAS No. 161). SFAS No. 161 expands disclosures about derivative instruments and hedging activities to provide a better understanding of a company’s use of derivatives and their effect on the financial statements. SFAS No. 161 is effective for fiscal years beginning on or after December 15, 2008. The Company’s adoption of this standard at the beginning of fiscal year 2009 did not result in a material impact to the Company’s consolidated financial statements.

In May 2008, the FASB issued FSP Accounting Principles Board (APB) Opinion No. 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP APB No. 14-1). The FSP requires the proceeds from the issuance of such convertible debt instruments to be allocated between a liability and an equity component in a manner that reflects the entity’s nonconvertible debt borrowing rate when interest expense is recognized in subsequent periods. The resulting debt discount is amortized over the period the convertible debt is expected to be outstanding as additional non-cash interest expense. FSP APB No. 14-1 is effective in fiscal years beginning after December 15, 2008 and requires retrospective application to all prior periods presented. The Company’s 2009 adoption will require historical financial statements for fiscal year 2005 through fiscal year 2008 to be adjusted to conform to the FSP’s new accounting treatment for both the 1.22% Convertible Senior Debentures due 2008 (1.22% Convertible Debentures) and 2.80% Convertible Senior Debentures due 2035 (2.80% Convertible Debentures), which were issued in April 2007 and December 2005, respectively (see Note 4). The retrospective application of this new accounting treatment will primarily result in a non-cash increase to interest expense reported in the Company’s historical financial statements. The Company currently estimates the retrospective annual increase to its 2008, 2007 and 2006 interest expense to be approximately $50 million, $34 million and $15 million, respectively. The exact impact on the Company’s historical financial statements will be reflected in the comparative financial information that will be included in the Company’s fiscal year 2009 financial statements.

NOTE 2 – ACQUISITIONS

The results of operations of businesses acquired have been included in the Company’s consolidated results of operations since the dates 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.

Fiscal Year 2008

EP MedSystems, Inc.: On July 3, 2008, the Company completed the acquisition of EP MedSystems, Inc. (EP MedSystems) for $95.7 million (consisting of $59.0 million in net cash consideration and direct acquisition costs and 0.9 million shares of St. Jude Medical common stock). EP MedSystems had been publicly traded on the NASDAQ Capital Market under the ticker symbol EPMD. EP MedSystems is based in West Berlin, New Jersey and develops, manufactures and markets medical devices for the electrophysiology market which are used for visualization, diagnosis and treatment of heart rhythm disorders. The Company acquired EP MedSystems to strengthen its portfolio of products used to treat heart rhythm disorders.

The goodwill recorded as a result of the EP MedSystems acquisition is not deductible for income tax purposes and was allocated entirely to the Company’s Atrial Fibrillation operating segment. The goodwill represents the strategic benefits of growing our Atrial Fibrillation product portfolio and the expected revenue growth from increased market penetration from future product and customers. In connection with the acquisition of EP MedSystems, the Company recorded $17.0 million of developed and core technology intangible assets that have estimated useful lives of 7 to 10 years and $3.3 million of customer relationship intangible assets that have estimated useful lives of 7 to 10 years. The aggregate EP MedSystems purchase price was allocated on a preliminary basis to the assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition.

33



Radi Medical Systems AB: On December 19, 2008, the Company completed the acquisition of Radi Medical Systems AB (Radi Medical Systems) for $248.9 million in net cash consideration, including direct acquisition costs. Radi Medical Systems is based in Uppsala, Sweden and develops, manufactures and markets products that provide precise measurements of intravascular pressure during a cardiovascular procedure and compression systems that arrest bleeding of the femoral and radial arteries following an intravascular medical device procedure. The Company acquired Radi Medical Systems to accelerate its cardiovascular growth platform in these two segments of the cardiovascular medical device market in which the Company previously had not participated.

The goodwill recognized as a result of the Radi Medical Systems acquisition is not deductible for income tax purposes and was allocated entirely to the Company’s Cardiovascular operating segment. The goodwill represents the strategic benefits of growing our Cardiovascular product portfolio and the expected revenue growth from increased market penetration from future products and customers. In connection with the acquisition of Radi Medical Systems, the Company recorded $46.0 million of developed and core technology intangible assets that have estimated useful lives of 8 to 10 years. The aggregate Radi Medical Systems purchase price was allocated on a preliminary basis to the assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition.

MediGuide, Inc.: On December 22, 2008, the Company completed the acquisition of MediGuide, Inc. (MediGuide) for $285.2 million in net consideration, which includes future estimated cash consideration payments of approximately $145 million and direct acquisition costs. The additional cash consideration payments consist of an estimated $111 million payment in November 2009 and an estimated $34 million payment in April 2010, which is being held as security for potential indemnification obligations of MediGuide. MediGuide was a development-stage company based in Haifa, Israel and has been focused on developing a Medical Positioning System (gMPSTM) technology that provides localization and tracking capability for interventional medical devices. As MediGuide was a development-stage company, the excess of the purchase price over the fair value of the net assets acquired was allocated to IPR&D, the principal asset acquired.

The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as a result of the significant acquisitions made by the Company in fiscal year 2008 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

EP MedSystems

 

Radi
Medical Systems

 

MediGuide

 

Total

 

Current assets

 

$

8,506

 

$

21,224

 

$

132

 

$

29,862

 

Goodwill

 

 

69,719

 

 

219,428

 

 

 

 

289,147

 

Other intangible assets

 

 

20,250

 

 

46,000

 

 

 

 

66,250

 

IPR&D

 

 

 

 

 

 

306,202

 

 

306,202

 

Deferred income taxes, net

 

 

17,213

 

 

 

 

 

 

17,213

 

Other long-term assets

 

 

1,101

 

 

6,629

 

 

408

 

 

8,138

 

Total assets acquired

 

$

116,789

 

$

293,281

 

$

306,742

 

$

716,812

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

21,084

 

$

31,405

 

 

21,580

 

 

74,069

 

Deferred income taxes, net

 

 

 

 

12,930

 

 

 

 

12,930

 

Net assets acquired

 

$

95,705

 

$

248,946

 

$

285,162

 

$

629,813

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid, net of cash acquired

 

$

58,994

 

$

248,946

 

$

140,104

 

 

448,044

 

Non-cash (SJM shares at fair value)

 

 

36,711

 

 

 

 

 

 

36,711

 

Future cash consideration

 

 

 

 

 

 

145,058

 

 

145,058

 

Net assets acquired

 

$

95,705

 

$

248,946

 

$

285,162

 

$

629,813

 

The Company also completed other acquisitions during 2008. On August 7, 2008, the Company’s CV’s segment acquired Datascope Corporation’s (Datascope) vascular closure business and collagen operations for $21.8 million in cash consideration and direct acquisition costs. The Company is holding an additional $3.0 million as security for potential indemnification obligations of Datascope, which may become payable under the applicable asset purchase agreement entered into between Datascope and the Company. This holdback amount, less any amounts offset against it, will be paid to Datascope 18 months following the closing date of the transaction. During 2008, the Company made other acquisitions, primarily acquiring businesses involved in the distribution of the Company’s products for aggregate cash consideration of $20.2 million, which was recorded within other intangible assets.

34



Fiscal Year 2007

During 2007, the Company acquired businesses involved in the distribution of the Company’s products for aggregate cash consideration of $12.2 million, which was recorded within other intangible assets.

Fiscal Year 2006

Advanced Neuromodulation Systems, Inc.: During 2006, the Company finalized the purchase price allocation relating to the acquisition of ANS. The impacts of finalizing the purchase price allocation, individually and in the aggregate, were not material. Overall, the Company recorded a $2.9 million net increase to goodwill upon finalization of the purchase accounting.

During 2006, the Company also acquired businesses involved in the distribution of the Company’s products for aggregate cash consideration of $38.8 million, which was recorded within other intangible assets.

NOTE 3 – GOODWILL AND OTHER INTANGIBLE ASSETS

The changes in the carrying amount of goodwill for each of the Company’s reportable segments for the fiscal years ended January 3, 2009 and December 29, 2007 were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

CRM/Neuro

 

CV/AF

 

Total

 

Balance at December 30, 2006

 

$

1,189,893

 

$

459,688

 

$

1,649,581

 

Foreign currency translation

 

 

7,079

 

 

653

 

 

7,732

 

Balance at December 29, 2007

 

 

1,196,972

 

 

460,341

 

 

1,657,313

 

Foreign currency translation

 

 

10,679

 

 

(641

)

 

10,038

 

EP Medsystems

 

 

 

 

69,719

 

 

69,719

 

Radi Medical Systems

 

 

 

 

219,428

 

 

219,428

 

Other

 

 

3,887

 

 

24,181

 

 

28,068

 

Balance at January 3, 2009

 

$

1,211,538

 

$

773,028

 

$

1,984,566

 

The following table provides the gross carrying amount of other intangible assets and related accumulated amortization (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

December 29, 2007

 

 

 

Gross
carrying
amount

 

Accumulated
amortization

 

Gross
carrying
amount

 

Accumulated
amortization

 

 

Purchased technology and patents

 

$

494,796

 

$

124,749

 

$

473,430

 

$

102,119

 

Customer lists and relationships

 

 

166,637

 

 

63,385

 

 

153,388

 

 

51,055

 

Trademarks and tradenames

 

 

22,651

 

 

4,789

 

 

23,300

 

 

3,236

 

Licenses, distribution agreements and other

 

 

5,529

 

 

3,155

 

 

6,749

 

 

1,757

 

 

 

$

689,613

 

$

196,078

 

$

656,867

 

$

158,167

 

Amortization expense of other intangible assets was $53.4 million, $53.9 million and $50.1 million for fiscal years 2008, 2007 and 2006, respectively. In 2008, the Company recorded a $37.0 million impairment charge to write down purchased technology intangible assets associated with its 2005 Velocimed acquisition and a $1.7 million impairment charge to write off ANS tradename intangible assets (see Note 8). In 2007, the Company recorded impairment charges of $23.7 million related to acquired intangible assets associated with a terminated distribution agreement (see Note 8). The gross carrying values and related accumulated amortization amounts for these impairment charges were written off in the respective periods.

The following table presents expected future amortization expense for amortizable intangible assets. Actual amounts of amortization expense may differ due to additional intangible assets acquired and foreign currency translation impacts.

35



Expected future amortization expense for amortizable intangible assets is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2009

 

2010

 

2011

 

2012

 

2013

 

After
2013

 

 

Amortization expense

 

$

56,083

 

$

55,892

 

$

55,479

 

$

53,081

 

$

51,806

 

$

221,194

 

NOTE 4 – DEBT

The Company’s long-term debt consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

January 3, 2009

 

December 29, 2007

 

Credit facility borrowings

 

$

500,000

 

$

 

Commercial paper borrowings

 

 

19,400

 

 

 

Term loan due 2011

 

 

360,000

 

 

 

1.02% Yen-denominated notes due 2010

 

 

230,088

 

 

182,493

 

Yen-denominated term loan due 2011

 

 

88,222

 

 

 

1.22% Convertible senior debentures

 

 

 

 

1,200,000

 

2.80% Convertible senior debentures

 

 

374

 

 

5,498

 

Other

 

 

3,518

 

 

 

Total long-term debt

 

 

1,201,602

 

 

1,387,991

 

Less: current portion of long-term debt

 

 

75,518

 

 

1,205,498

 

Long-term debt

 

$

1,126,084

 

$

182,493

 

Credit facility borrowings: In December 2006, the Company entered into a 5-year, $1.0 billion committed credit facility that it may draw on for general corporate purposes and to support its commercial paper program. Borrowings under this facility bear interest at the United States Prime Rate (Prime Rate) or United States Dollar London InterBank Offered Rate (LIBOR) plus 0.235%, at the election of the Company. In the event over half of the facility is drawn upon, an additional five basis points is added to the elected Prime Rate or LIBOR rate. Additionally, the interest rate is subject to adjustment in the event of a change in the Company’s credit ratings. In October 2008, the Company borrowed $500.0 million under this credit facility to fund the retirement of the Company’s 1.22% Convertible Debentures in December 2008. There were no outstanding borrowings under this credit facility during fiscal years 2007 or 2006.

During the first quarter of 2007, the Company borrowed $350.0 million under an interim liquidity facility to finance a portion of common stock repurchases made during the first half of 2007. Borrowings under this liquidity facility bore interest at a weighted average effective interest rate of 5.7%. On April 25, 2007, this facility expired and the Company repaid the related outstanding borrowings using a portion of the proceeds from the issuance of the 1.22% Convertible Debentures.

Commercial paper borrowings: The Company’s commercial paper program provides for the issuance of short-term, unsecured commercial paper with maturities up to 270 days. The Company had outstanding commercial paper borrowings of $19.4 million at January 3, 2009 and no outstanding commercial paper borrowings at December 29, 2007. During 2008 and 2007 the Company issued commercial paper at weighted average effective interest rates of 1.0% and 5.4%, respectively. Any future commercial paper borrowings would bear interest at the applicable then-current market rates. The Company classifies all of its commercial paper borrowings as long-term debt as the Company has the ability to repay any short-term maturity with available cash from its existing long-term, committed credit facility.

Term loan due 2011: On December 18, 2008, the Company entered into a 3-year, unsecured term loan totaling $360.0 million, which can be used for general corporate purposes or to refinance certain other outstanding borrowings of the Company. These borrowings bear interest at LIBOR plus 2.0%, although the Company may elect the Prime Rate plus 1.0%. The interest rates are subject to adjustment in the event of a change in the Company’s credit ratings. The Company is required to make quarterly principal payments in the amount of 5% of the original outstanding borrowings. The Company had the option to make additional borrowings under this term loan, and in January 2009, the Company elected to borrow an additional $180.0 million resulting in total borrowings of $540.0 million under this 3-year term loan.

1.02% Yen-denominated notes due 2010: In May 2003, the Company issued 7-year, 1.02% unsecured notes totaling 20.9 billion Yen (the equivalent of $230.1 million at January 3, 2009 and $182.5 million at December 29, 2007). Interest payments are required on a semi-annual basis and the entire principal balance is due in May 2010. The principal amount recorded on the balance sheet fluctuates based on the effects of foreign currency translation. As of January 3, 2009, the fair value of this term loan approximated its carrying value.

36



Yen-denominated term loan due 2011: On December 9, 2008, the Company entered into a 3-year, Yen-denominated unsecured term loan in Japan (Yen Term Loan) totaling 8.0 billion Japanese Yen (the equivalent of $88.2 million at January 3, 2009). The borrowings bear interest at the Yen LIBOR plus 2.0%. Interest payments are required on a semi-annual basis and the entire principal balance is due in December 2011. The principal amount recorded on the balance sheet fluctuates based on the effects of foreign currency translation.

1.22% Convertible Senior Debentures: In April 2007, the Company issued $1.2 billion aggregate principal amount of 1.22% Convertible Debentures that matured on December 15, 2008. Interest on the 1.22% Convertible Debentures was payable on June 15 and December 15 of each year. Under certain circumstances, holders had the right to convert their 1.22% Convertible Debentures at an initial conversion rate of 19.2101 shares per $1,000 principal amount (equivalent to an initial conversion price of approximately $52.06 per share). Upon conversion, the Company was required to satisfy 100% of the principal amount of the 1.22% Convertible Debentures solely in cash, with any amounts above the principal amount to be satisfied in shares of the Company’s common stock, cash or a combination of common stock and cash, at the Company’s election. On December 15, 2008, the Company retired the 1.22% Convertible Debentures for cash, which was primarily funded by borrowings and cash from operations.

In connection with the issuance of the 1.22% Convertible Debentures, the Company had purchased a $101.0 million call option in a private transaction to receive shares of its common stock. The purchase of the call option was intended to offset potential dilution to the Company’s common stock upon potential future conversion of the 1.22% Convertible Debentures. The call option was exercisable at approximately $52.06 per share and allowed the Company to receive the same number of shares and/or amount of cash from the counterparty as the Company would be required to deliver upon potential future conversion of the 1.22% Convertible Debentures. The call option was not exercised, and expired on December 15, 2008.

Separately, the Company also sold warrants for approximately 23.1 million shares of its common stock in a private transaction. Over a two-month period beginning in April 2009, the Company may be required to issue shares of its common stock to the counterparty if the average price of the Company’s common stock during a defined period exceeds the warrant exercise price of approximately $60.73 per share. The Company received proceeds of $35.0 million from the sale of these warrants, which were recorded as an increase to shareholders’ equity.

2.80% Convertible Senior Debentures: In December 2005, the Company issued $660.0 million aggregate principal amount of 30-year 2.80% Convertible Debentures. The Company has the right to redeem some or all of the 2.80% Convertible Debentures for cash at any time. Interest on the 2.80% Convertible Debentures is payable on June 15 and December 15 of each year. Holders of the 2.80% Convertible Debentures can require the Company to repurchase for cash some or all of the 2.80% Convertible Debentures on December 15 in the years 2006, 2008, 2010, 2015, 2020, 2025 and 2030. In December 2006 and December 2008, holders required the Company to repurchase $654.5 million and $5.1 million, respectively, of the 2.80% Convertible Debentures for cash. As of January 3, 2009, $0.4 million aggregate principal amount of the 2.80% Convertible Debentures remained outstanding. The remaining holders may convert each of the $1,000 principal amounts of the 2.80% Convertible Debentures into 15.5009 shares of the Company’s common stock (an initial conversion price of approximately $64.51) under certain circumstances. The total number of contingently issuable shares that could be issued to satisfy conversion of the remaining $0.4 million aggregate principal amount of the 2.80% Convertible Debentures is not material.

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: $26.4 million in 2009; $20.5 million in 2010; $15.2 million in 2011; $12.0 million in 2012; $10.2 million in 2013; and $11.3 million in years thereafter. Rent expense under all operating leases was $28.6 million, $27.4 million and $24.6 million in fiscal years 2008, 2007 and 2006, respectively.

37



Litigation

The Company accrues a liability for costs related to claims, including future legal costs, settlements and judgments, where it has assessed that a loss is probable and an amount can be reasonably estimated. The Company also records a receivable from its product liability insurance carriers for amounts expected to be recovered.

Silzone® Litigation and Insurance Receivables: In July 1997, the Company began marketing mechanical heart valves which incorporated Silzone® coating. The Company later began marketing heart valve repair products incorporating Silzone® coating. Silzone® coating was intended to reduce the risk of endocarditis, a bacterial infection affecting heart tissue, which is associated with replacement heart valve surgery. In January 2000, the Company initiated a voluntary field action for products incorporating Silzone® coating after receiving information from a clinical study that patients with a Silzone®-coated heart valve had a small, but statistically significant, increased incidence of explant due to paravalvular leak compared to patients in that clinical study with heart valves that did not incorporate Silzone® coating.

Subsequent to the Company’s voluntary field action, the Company has been sued in various jurisdictions beginning in March 2000 by some patients who received a product with Silzone® coating and, as of February 18, 2009, such cases are pending in the United States and Canada. Some of these claimants allege bodily injuries as a result of an explant or other complications, which they attribute to Silzone®-coated products. Others, who have not had their Silzone®-coated heart valve explanted, seek compensation for past and future costs of special monitoring they allege they need over and above the medical monitoring all other 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.

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

In October 2001, eight class-action complaints were consolidated into one class action case by the District Court. The Company requested the Eighth Circuit Court of Appeals (the Eighth Circuit) to review the District Court’s initial class certification orders and, in October 2005, the Eighth Circuit issued a decision reversing the District Court’s class certification rulings and directed the District Court to undertake further proceedings. In October 2006, the District Court granted plaintiffs’ renewed motion to certify a nationwide consumer protection class under Minnesota’s consumer protection statutes and Private Attorney General Act. The Company again requested the Eighth Circuit to review the District Court’s class certification orders and, in April 2008, the Eighth Circuit again issued a decision reversing the District Court’s October 2006 class certification rulings. The order by the Eighth Circuit returned the case to the District Court for continued proceedings. Plaintiffs have recently requested the District Court to certify a new class. The Company is vigorously defending against such certification.

On February 12, 2009, the District Court signed an order allowing two individuals to withdraw as representatives in the purported class action. Thus, as of February 18, 2009, there are three individual Silzone® cases pending in federal court. The plaintiffs in these cases are requesting damages in excess of $75 thousand. The complaint in the case that was most recently transferred to the MDL court was served upon the Company in December 2008.

There are eight individual state court suits concerning Silzone®-coated products pending as of February 18, 2009, involving eight patients. These cases are venued in Minnesota, Nevada and Texas. The complaints in these state court cases are requesting damages ranging from $10 thousand to $100 thousand and, in some cases, seek an unspecified amount. The most recent individual state court complaint was served upon the Company in February 2008. These state court cases are proceeding in accordance with the orders issued by the judges in those matters. 

In addition, a lawsuit seeking a class action for all persons residing in the European Economic Union member jurisdictions who have had a heart valve replacement and/or repair procedure using a product with Silzone® coating was filed in Minnesota state court and served upon the Company in February 2004 by two European citizens who now reside in Canada. The complaint seeks damages in an unspecified amount for the class, and in excess of $50 thousand for each plaintiff. The complaint also seeks injunctive relief in the form of medical monitoring. The Company opposed the plaintiffs’ pursuit of this case on jurisdictional, procedural and substantive grounds, and in April 2008, the Minnesota state court denied the plaintiffs’ request for class certification. The time for appeal has expired. The class representatives in this matter have not dismissed their individual claims, and that case is one of the eight pending individual state court actions mentioned above.

38



In Canada, there are also four class-action cases and one individual case pending against the Company. In one such case in Ontario, the court certified that a class action involving Silzone® patients may proceed, and the trial of the initial phase of this matter may occur as early as April 2009. A second case seeking class action status in Ontario has been stayed pending resolution of the other Ontario class action. A case filed as a class action in British Columbia remains pending. A court in Quebec has certified a class action, and that matter is proceeding in accordance with that court's orders. Additionally, the Company has been served with lawsuits by the British Columbia Provincial health insurer and the Quebec Provincial health insurer to recover the cost of insured services furnished or to be furnished to class members in the class actions pending in British Columbia and Quebec, respectively. The complaints in the Canadian cases request damages ranging from 1.5 million to 2.0 billion Canadian Dollars (the equivalent to $1.2 million to $1.6 billion at January 3, 2009).

In France, one case involving one plaintiff was pending as of February 18, 2009. In November 2004, an Injunctive Summons to Appear was served, requesting damages in excess of 3 million Euros (the equivalent to $4.2 million at January 3, 2009).

The Company is not aware of any unasserted claims related to Silzone®-coated products. Company management believes that the final resolution of the Silzone® cases will take a number of years.

The Company has recorded an accrual for probable legal costs that it will incur to defend the various cases involving Silzone®-coated products, and the Company has recorded a receivable from its product liability insurance carriers for amounts expected to be recovered. The Company has not accrued for any amounts associated with settlements or judgments because potential losses cannot be reasonably estimated. Based on the Company’s experience in these types of individual 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. Management expects that any costs (the material components of which are settlements, judgments, legal fees and other related defense costs) not covered by the Company’s product liability insurance policies or existing reserves will not have a material adverse effect on the Company’s consolidated financial position, although such costs may be material to the Company’s consolidated earnings and cash flows of a future period. As of January 3, 2009, the Company’s Silzone® litigation reserve was $22.3 million and its receivable from insurance carriers was $25.5 million.

A summary of the activity relating to the Silzone® litigation reserve for the fiscal years ended January 3, 2009 and December 29, 2007 is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

Balance at December 30, 2006

 

$

39,494

 

 

 

 

 

 

Accrued costs adjustment

 

 

(9,000

)

Cash payments

 

 

(3,591

)

Balance at December 29, 2007

 

 

26,903

 

 

Cash payments

 

 

(4,595

)

Balance at January 3, 2009

 

$

22,308

 

The Company’s remaining product liability insurance for Silzone® claims consists of two $50 million layers, each of which is covered by one or more insurance companies. The current $50 million layer of insurance is covered by American Insurance Company (AIC). In December 2007, AIC initiated a lawsuit in Minnesota Federal District Court seeking a court order declaring that it is not required to provide coverage for a portion of the Silzone® litigation defense and indemnity expenses that the Company may incur in the future. The Company believes the claims of AIC are without merit and plans to vigorously defend against the claims AIC has asserted. The insurance broker that assisted the Company in procuring the insurance with AIC has recently been added as a party to the case. For all Silzone® legal costs incurred, the Company records insurance receivables for the amounts that it expects to recover.

Part of the Company’s final layer of insurance ($20.0 million of the final $50.0 million layer) is covered by Lumberman’s Mutual Casualty Insurance, a unit of the Kemper Insurance Companies (collectively referred to as Kemper). Prior to being no longer rated by A.M. Best, Kemper’s financial strength rating was downgraded to a “D” (poor). Kemper is currently in “run off,” which means it is no longer issuing new policies, and therefore, is not generating any new revenue that could be used to cover claims made under previously-issued policies. In the event Kemper is unable to pay claims directed to it, the Company believes the other insurance carriers in the final layer of insurance will take the position that the Company will be directly liable for any claims and costs that Kemper is unable to pay. It is possible that Silzone® costs and expenses will reach the limit of the final Kemper layer of insurance coverage, and it is possible that Kemper will be unable to meet its full obligations to the Company. Therefore, the Company could incur an expense up to $20.0 million for which it would have otherwise been covered. While potential losses are possible, the Company has not accrued for any such losses as they are not reasonably estimable at this time.

39



Guidant 1996 Patent Litigation: In November 1996, Guidant Corporation (Guidant), which became a subsidiary of Boston Scientific Corporation in 2006, sued the Company 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 ICDs and alleging that the Company was infringing those patents.

Guidant’s original suit alleged infringement of four patents by the Company. Guidant later dismissed its claim on the first patent and the district court ruled that the second patent was invalid, and this ruling was later upheld by the Court of Appeals for the Federal Circuit (CAFC). The third patent was found to be invalid by the district court. The fourth patent (the ‘288 patent) was initially found to be invalid by the district court judge, but the CAFC reversed this decision in August 2004. The case was returned to the district court in November 2004. The district court issued rulings on claims construction and a response to motions for summary judgment in March 2006. Guidant’s special request to appeal certain aspects of these rulings was rejected by the CAFC. In March 2007, the district court judge responsible for the case granted summary judgment in favor of the Company, ruling that the only remaining patent claim (the ‘288 patent) asserted against the Company in the case was invalid. In April 2007, Guidant appealed the district court’s March 2007 and March 2006 rulings. In December 2008, the CAFC upheld the March 2006 rulings of the district court but also reversed the district court’s March 2007 ruling that the ‘288 patent was invalid. As such, based on that ruling, although the invalidity of the patent has now been overturned, the damages in the case going forward are limited to those relatively few instances prior to the expiration of the patent in 2003 when the cardioversion therapy method described in the only remaining claim of the ‘288 patent is actually practiced.

While the parties have filed requests with the CAFC requesting that the entire CAFC rehear some of the issues addressed in the December 2008 decision, the CAFC has not yet ruled on these requests.

The ‘288 patent expired in December 2003. Accordingly, the final outcome of the litigation involving the ‘288 patent cannot result in an injunction precluding the Company from selling ICD products in the future. Sales of the Company’s ICD products in which Guidant asserts infringement of the ‘288 patent were approximately 18% and 16% of the Company’s consolidated net sales during fiscal years 2003 and 2002, respectively. Additionally, based on a July 2006 agreement, in exchange for the Company’s agreement not to pursue the recovery of attorneys’ fees or assert certain claims and defenses, Guidant agreed it would not seek recovery of lost profits, prejudgment interest or a royalty rate in excess of 3% of net sales for any patents found to be infringed upon by the Company. This agreement had the effect of limiting the Company’s financial exposure. However, any potential losses arising from any legal settlements or judgments could be material to the Company’s consolidated earnings, financial position and cash flows. The Company has not accrued any amounts for legal settlements or judgments related to the Guidant 1996 patent litigation. Although the Company believes that the assertions and claims in the Guidant 1996 patent litigation are without merit, potential losses arising from any legal settlements or judgments are possible, but not reasonably estimable at this time.

Ohio OIG Investigation: In July 2007, the Company received a civil subpoena from the U.S. Department of Health and Human Services, Office of the Inspector General (OIG), requesting documents regarding the Company’s relationships with ten Ohio hospitals during the period from 2003 through 2006. The Company has received follow-up requests from the U.S. Department of Justice and the U.S. Attorney’s Office in Cleveland regarding this matter. The Company is cooperating with the investigation and is continuing to work with the OIG in responding to the subpoena.

Boston U.S. Attorney Investigation: In October 2005, the U.S. Department of Justice, acting through the U.S. Attorney’s office in Boston, commenced an industry-wide investigation into whether the provision of payments and/or services by makers of ICDs and pacemakers to doctors or other persons constitutes improper inducements under the federal health care program anti-kickback law. As part of this investigation, the Company received a civil subpoena from the U.S. Attorney’s office in Boston requesting documents created since January 2000 regarding the Company’s practices related to ICDs, pacemakers, lead systems and related products marketed by the Company’s Cardiac Rhythm Management segment. The Company understands that its principal competitors in the cardiac rhythm management therapy areas received similar civil subpoenas. The Company received an additional subpoena from the U.S. Attorney’s office in Boston in September 2006, requesting documents created since January 2002 related to certain employee expense reports and certain ICD and pacemaker purchasing arrangements. The Company is cooperating with the investigation and has been producing documents and witnesses as requested. In December 2008, the U.S. Attorney’s Office in Boston delivered a third subpoena issued by the Department of Health & Human Services Office of Inspector General requesting the production of documents relating to implantable cardiac rhythm device and pacemaker warranty claims.

40



In October 2008, the Company received a letter from the Civil Division of the U.S. Department of Justice stating that it was investigating the Company for potential False Claims Act and common law violations relating to the sale of the Company’s Epicor surgical ablation devices. The Department of Justice is investigating whether companies marketed surgical ablation devices for off-label treatment of atrial fibrillation. Other manufacturers of medical devices used in the treatment of atrial fibrillation have reported receiving similar letters. The letter requests that we provide documents from January 1, 2005, to present relating to FDA approval and marketing of Epicor ablation devices.

French Competition Investigation: In January 2007, the French Council of Competition issued a Statement of Objections alleging that the Company’s subsidiary, St. Jude Medical France, had agreed with other suppliers of certain medical devices in France to collectively refrain from responding to a 2001 tender conducted by a group of hospital centers in France. In December 2007, the French Council of Competition issued a finding that assessed a fine against the Company, the amount of which was not material to the Company’s consolidated earnings, financial position and cash flows. The Company has paid the fine. Several of the parties to this proceeding have filed appeals.

Securities Class Action Litigation: In April and May 2006, five shareholders, each purporting to act on behalf of a class of purchasers during the period January 25 through April 4, 2006 (the Class Period), separately sued the Company and certain of its officers in federal district court in Minnesota alleging that the Company made materially false and misleading statements during the Class Period relating to financial performance, projected earnings guidance and projected sales of ICDs. The complaints, all of which seek unspecified damages and other relief, as well as attorneys’ fees, have been consolidated. The Company filed a motion to dismiss, which was denied by the district court in March 2007. The discovery process concluded in September, and the Company has filed a motion for summary judgment which was argued before the Court on January 23, 2009. The Company expects the Court will issue a decision in 2009. The Company intends to vigorously defend against the claims asserted in these actions. The Company’s directors and officers liability insurance provides $75 million of insurance coverage for the Company, the officers and the directors, after a $15 million self-insured retention level has been reached.

Derivative Action: In February 2007, a derivative action was filed in state court in Minnesota which purported to bring claims belonging to the Company against the Company’s Board of Directors and various officers and former officers for alleged malfeasance in the management of the Company. The claims were based on substantially the same allegations as those underlying the securities class action litigation described above. The defendants (consisting of the Company’s Board of Directors and various officers and former officers) filed a motion to dismiss, and in June 2007 the state court granted the motion, thus dismissing the derivative case for failure of the complainant to make a demand on the Board. In September 2007, the plaintiff sent a shareholder demand letter to the Board. The Board considered the letter at its October 25, 2007 Board meeting and requested that the complainant provide it with details to substantiate the allegations. In June 2008, the complainant filed a derivative action against the defendants again. The court denied the defendants’ motion to dismiss concerning that complaint. To date, the complainant has not provided any material facts to support the allegations. The plaintiff has indicated that he plans to file an amended complaint, but has not done so as of February 18, 2009. The defendants intend to continue to vigorously defend against the claims raised in this action.

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

NOTE 6 – SHAREHOLDERS’ EQUITY

Capital Stock: The Company’s authorized capital consists of 25 million shares of $1.00 per share par value preferred stock and 500 million shares of $0.10 per share par value common stock. There were no shares of preferred stock issued or outstanding during 2008, 2007, or 2006.

Share Repurchases: On February 22, 2008, the Company’s Board of Directors authorized a share repurchase program of up to $250.0 million of the Company’s outstanding common stock. On April 8, 2008, the Company’s Board of Directors authorized an additional $50.0 million of share repurchases as part of this share repurchase program. The Company completed the repurchases under the program on May 1, 2008. In total, the Company repurchased 6.7 million shares for $300.0 million at an average repurchase price of $44.51 per share.

In January 2007, the Company’s Board of Directors authorized a share repurchase program of up to $1.0 billion of the Company’s outstanding common stock. In the first quarter of 2007, the Company repurchased $700.0 million of its outstanding common stock. The Company completed the repurchases under the program on May 8, 2007. In total, the Company repurchased 23.6 million shares for $1.0 billion at an average repurchase price of $42.34 per share.

41



In April 2006, the Company’s Board of Directors authorized a share repurchase program of up to $700.0 million of the Company’s outstanding common stock. The $700.0 million share repurchase program replaced an earlier share repurchase program, under which the Company was authorized to repurchase up to $300.0 million of its outstanding common stock. No stock had been repurchased under the earlier program. In the second quarter of 2006, the Company repurchased 18.6 million shares for $700.0 million at an average repurchase price of $37.68 per share, which was recorded as a $593.5 million aggregate reduction of common stock and additional paid-in capital and a $106.5 million reduction in retained earnings.

NOTE 7 – STOCK-BASED COMPENSATION

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 have an exercise price equal to the fair market value on the date of grant, and generally, an eight-year contractual life and four-year vesting term. Since 2000, all stock option awards have been granted with an eight-year contractual term regardless of the maximum allowable under the plan. Restricted stock awards under these plans generally vest over a four-year period. During the vesting period, ownership of the shares cannot be transferred. Restricted stock is considered issued and outstanding at the grant date and has the same dividend and voting rights as other common stock. Directors can elect to receive half or their entire annual retainer in the form of a restricted stock grant with a six-month vesting term. At January 3, 2009, the Company had 16.8 million shares of common stock available for stock option grants under these plans. The Company has the ability to grant a portion of the remaining shares in the form of restricted stock. Specifically, in lieu of granting up to 15.8 million stock options under these plans, the Company may grant up to 7.0 million restricted stock awards (for certain grants of restricted stock awards, the number of shares available are reduced by 2.25 shares). Additionally, in lieu of granting up to 0.1 million stock options under these plans, the Company may grant up to 0.1 million restricted stock awards (for certain grants of restricted stock awards, the number of shares available are reduced by one share). The remaining 0.9 million shares of common stock are available for stock option grants.

The Company also has an Employee Stock Purchase Plan (ESPP) that allows participating employees to purchase newly issued shares of the Company’s common stock at a discount through payroll deductions. The ESPP consists of a 12-month offering period whereby employees can purchase shares at 85% of the market value at either the beginning of the offering period or the end of the offering period, whichever price is lower. Employees purchased 0.7 million, 0.7 million and 0.5 million shares in 2008, 2007 and 2006, respectively. At January 3, 2009, 4.3 million shares of common stock were available for future purchases under the ESPP.

Valuation Assumptions

The Company uses the Black-Scholes standard option pricing model (Black-Scholes model) to determine the fair value of stock options and ESPP purchase rights. The determination of the fair value of the awards on the date of grant using the Black-Scholes model is affected by the Company’s stock price as well as assumptions of other variables, including projected employee stock option exercise behaviors, risk-free interest rate, expected volatility of the Company’s stock price in future periods and expected dividend yield. The weighted average fair values of ESPP purchase rights granted to employees during fiscal years 2008, 2007 and 2006 were $13.12, $12.07 and $10.12, respectively. The fair value of restricted stock is based on the Company’s closing stock price on the date of grant. The weighted average fair values of restricted stock granted during fiscal years 2008, 2007 and 2006 were $40.52, $41.42 and $34.04, respectively.

The following table provides the weighted average fair value of stock options granted to employees during fiscal years 2008, 2007 and 2006 and the related weighted average assumptions used in the Black-Scholes model:

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

Fair value of options granted

 

$

9.99

 

$

13.13

 

$

11.23

 

 

 

 

 

 

 

 

 

 

 

 

Assumptions used:

 

 

 

 

 

 

 

 

 

 

Expected life (years)

 

 

4.2

 

 

4.2

 

 

4.1

 

Risk-free interest rate

 

 

1.8

%

 

3.6

%

 

4.5

%

Volatility

 

 

37.3

%

 

33.4

%

 

27.8

%

Dividend yield

 

 

0

%

 

0

%

 

0

%

42



Expected life: The Company analyzes historical employee exercise and termination data to estimate the expected life assumption. For determining the fair value of stock options under SFAS No. 123(R), the Company uses different expected lives for the general employee population and officers and directors. In preparing to adopt SFAS No. 123(R), the Company examined its historical pattern of stock option exercises to determine if there was a discernable pattern as to how different classes of employees exercised their stock options. The Company’s analysis showed that officers and directors held their stock options for a longer period of time before exercising compared to the rest of the employee population. Prior to adopting SFAS No. 123(R), the Company used the entire employee population for estimating the expected life assumptions.

Risk-free interest rate: The rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity equal to or approximating the expected life of the options.

Volatility: Beginning in the fourth quarter of 2008, the Company calculated its expected volatility assumption by blending the historical and implied volatility. The historical volatility is based on the daily closing prices of the Company’s common stock over a period equal to the expected term of the option. Market-based implied volatility is based on utilizing market data of actively traded options on the Company’s stock, from options at- or near-the-money, at a point in time as close to the grant date of the employee options as reasonably practical and with similar terms to the employee share option, or a remaining maturity of at least six months if no similar terms are available. The historical volatility of the Company’s common stock price over the expected term of the option is a strong indicator of the expected future volatility. In addition, implied volatility takes into consideration market expectations of how future volatility will differ from historical volatility. The Company does not believe that one estimate is more reliable than the other, and as a result, the Company uses an equal weighting of historical volatility and market-based implied volatility. Prior to the fourth quarter of 2008, the Company calculated the expected volatility assumption exclusively on market-based implied volatility. The impact of changing the method of determining expected volatility was not material to fiscal year 2008 stock compensation expense. The Company changed the method of determining expected volatility to take into consideration how future volatility experience over the expected life of the option may differ from short-term volatility experience and thus provide a better estimate of expected volatility over the expected life of employee stock options.

Dividend yield: The Company does not anticipate paying any cash dividends in the foreseeable future and therefore a dividend yield of zero is assumed.

Stock Option and Restricted Stock Activity

The following table summarizes stock option activity under all stock compensation plans, including options assumed in connection with acquisitions, during the fiscal year ended January 3, 2009:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Options
(in thousands)

 

Weighted
Average
Exercise
Price

 

Weighted
Average
Contractual
Term (years)

 

Aggregate
Instrinsic
Value
(in thousands)

 

Outstanding at December 29, 2007

 

 

38,325

 

$

30.63

 

 

 

 

 

 

 

Granted

 

 

8,067

 

 

30.82

 

 

 

 

 

 

 

Canceled

 

 

(1,413

)

 

41.77

 

 

 

 

 

 

 

Exercised

 

 

(7,658

)

 

18.42

 

 

 

 

 

 

 

Outstanding at January 3, 2009

 

 

37,321

 

$

32.76

 

 

4.8

 

$

187,662

 

Vested or expected to vest

 

 

28,454

 

$

33.08

 

 

3.9

 

$

159,208

 

Exercisable at January 3, 2009

 

 

22,735

 

$

31.08

 

 

3.3

 

$

158,875

 

The aggregate intrinsic value of options outstanding and options exercisable is based on the Company’s closing stock price on the last trading day of the fiscal year for in-the-money options. The total intrinsic value of options exercised during fiscal years 2008, 2007 and 2006 was $182.6 million, $335.5 million and $105.6 million, respectively.

43



The following table summarizes restricted stock activity under all stock compensation plans, including restricted stock assumed in connection with acquisitions, during the year ended January 3, 2009:

 

 

 

 

 

 

 

 

 

 

Restricted Stock
(in thousands)

 

Weighted Average
Grant Price

 

Unvested balance at December 29, 2007

 

 

142

 

$

47.13

 

Granted

 

 

10

 

 

40.52

 

Vested

 

 

(74

)

 

46.51

 

Canceled

 

 

(11

)

 

47.94

 

Unvested balance at January 3, 2009

 

 

67

 

$

46.61

 

In connection with the acquisition of ANS in November 2005, the Company issued 209,364 shares of replacement St. Jude Medical restricted stock at a weighted average grant price of $48.17, which vest over a four year period. The total fair value of restricted stock vested during fiscal years 2008, 2007 and 2006 was $3.1 million, $3.3 million and $0.6 million, respectively.

At January 3, 2009, there was $127.6 million of total unrecognized stock-based compensation expense, adjusted for estimated forfeitures, which is expected to be recognized over a weighted average period of 3.1 years and will be adjusted for any future changes in estimated forfeitures.

NOTE 8 – PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT (IPR&D) AND SPECIAL CHARGES

IPR&D Charges

IPR&D is defined as the value assigned to those projects for which the related products have not yet reached technological feasibility and have no future alternative use. The primary basis for determining the technological feasibility of these projects at the time of acquisition is obtaining regulatory approval to market the underlying products in an applicable geographic region. The Company expenses the value attributed to these projects in conjunction with the related business acquisition or asset purchase.

MediGuide, Inc.: In December 2008, the Company acquired privately-held MediGuide, a development-stage company that has been focused on developing its Medical Positioning System (gMPSTM) technology for localization and tracking capability for interventional medical devices. The acquisition will provide the Company with exclusive rights to use and develop MediGuide’s gMPSTM technology. As MediGuide was a development-stage company, the excess of the purchase price over the fair value of the net assets acquired was allocated on a pro-rata basis to the net assets acquired. Accordingly, the excess purchase price was allocated to IPR&D, the principal asset acquired. At the date of acquisition, $306.2 million of the purchase price was expensed as IPR&D since technological feasibility of the underlying projects had not yet been reached and such technology had no future alternative use. The Company expects to incur up to approximately $30 million to bring the technology to commercial viability on a worldwide basis within two to three years.

Other: In December 2008, the Company also made an additional minority investment in a developmental-stage company and, in accordance with step-acquisition accounting treatment under the equity method of accounting, allocated the excess purchase price over the fair value of the investee’s net assets to IPR&D, the principal asset acquired. At the December 2008 investment date, $11.6 million of IPR&D was expensed since technological feasibility of the underlying projects had not yet been reached and such technology had no future alternative use. Additionally, the Company recognized $1.6 million of IPR&D charges in 2008 related to the purchase of intellectual property in its CRM and CV segments since the related technological feasibility had not yet been reached and such technology had no future alternative use.

Savacor, Inc.: In December 2005, the Company acquired privately-held Savacor, Inc. (Savacor) to complement the Company’s development efforts in heart failure diagnostic and therapy guidance products. As Savacor was a development-stage company, the excess of the purchase price over the fair value of the net assets acquired was allocated on a pro-rata basis to the net assets acquired. Accordingly, the majority of the excess purchase price was allocated to IPR&D, the principal asset acquired. At the date of acquisition, $45.7 million of the purchase price was expensed as IPR&D since technological feasibility of the underlying projects had not yet been reached and such technology had no future alternative use. Through January 3, 2009, the Company has incurred costs of approximately $16 million related to these projects. The Company expects to incur approximately $30 million to bring the device to commercial viability on a worldwide basis within four years.

44



Advanced Neuromodulation Systems, Inc.: In November 2005, the Company acquired ANS to expand the Company’s implantable microelectronics technology programs and provide the Company a presence in the neuromodulation segment of the medical device industry. At the date of acquisition, $107.4 million of the purchase price was expensed as IPR&D related to projects that had not yet reached technological feasibility and had no future alternative use. The majority of the IPR&D acquired relates to in-process projects for next-generation implantable pulse generator (IPG) devices as well as next-generation leads that deliver electrical impulses to targeted nerves that are causing pain. Through January 3, 2009, the Company has incurred costs of approximately $13 million related to these projects. The Company expects to incur approximately $6 million within the next three years to bring these devices to commercial viability on a worldwide basis.

Special Charges

Fiscal Year 2008

Impairment Charges: In September 2004, the Company completed making payments under a technology license agreement and was granted a fully paid-up license that provided access to patents covering technology used in its CRM devices. In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, whenever events or changes in circumstances indicate that a long-lived asset’s carrying amount may not be recoverable, the Company tests the asset for impairment. In 2008, the Company determined that a large portion of the technology under the license agreement was no longer fully utilized in the Company’s products and that certain of the patents under the license were no longer valid based upon recent patent law developments. Based upon these developments and changes in circumstances, the Company recognized an impairment charge of $43.5 million to cost of sales to write the technology license agreement down to its fair value.

In 2008, the Company experienced lower than forecasted sales of certain products in the Cardiovascular division associated with its 2005 acquisition of Velocimed. Based upon the recent unfavorable sales performance as well as termination of a clinical trial, the Company reduced the future revenue and cash flow projections relating to these products. Accordingly, the Company tested the related purchased technology intangible assets for impairment in the fourth quarter of 2008 and recognized a $37.0 million impairment charge to write down the related intangible assets to their remaining fair value. The Company also recognized other impairment charges of $5.8 million in 2008 primarily related to assets in the Cardiovascular division that will no longer be utilized.

In December 2008, the Company discontinued the use of the ANS tradename. The Company had acquired ANS in November 2005 and used the related tradename through its discontinuance in December 2008. Accordingly, the Company wrote off the ANS tradename intangible assets and recognized a $1.7 million impairment charge.

Inventory-related Charges: In 2008, the Company entered into purchase contracts in the normal course of business for certain raw material commodities that are used in the manufacture of its products. Favorable decreases in commodity prices in the fourth quarter of 2008 resulted in the Company’s electing to terminate and exit the contracts, paying $10.7 million in termination costs, which was recorded as a special charge in cost of sales.

The Company also recognized inventory obsolescence charges related to inventory that is not expected to be sold due to the termination of a distribution agreement in Japan. When the Company elected to terminate the distribution agreement in December 2007, the Company recorded a $4.0 million special charge in 2007 related to inventory that it estimated would not be sold. The Company increased this estimate in 2008 and recorded an additional $3.0 million special charge in cost of sales.

Other Charges: In 2008, the Company launched its MerlinTM @home wireless patient monitoring system and committed to provide this system without charge to existing St. Jude Medical CRM patients. In connection with the completion of this roll-out in the fourth quarter of 2008, the Company recorded a $7.4 million special charge in cost of sales to accrue for the related costs. The Company also recognized $5.5 million of other unrelated costs.

In order to enhance segment comparability and reflect management’s focus on the ongoing operations of the Company, the 2008 special charges have not been recorded in the individual reportable segments.

45



Fiscal Year 2007

Patent Litigation: In June 2007, the Company settled a patent litigation matter with Guidant (a subsidiary of Boston Scientific) and Mirowski Family Ventures, L.L.C. and recorded a special charge of $35.0 million.

Restructuring Activities: In December 2007, Company management continued its efforts to streamline its operations and implemented additional restructuring actions primarily focused at international locations. As a result, the Company recorded special charges totaling $29.1 million in 2007 consisting of employee termination costs ($17.9 million) and other costs ($11.2 million). Of the total $29.1 million charge, $5.9 million was recorded in cost of sales. Employee termination costs related to severance and benefit costs for approximately 200 individuals identified for employment termination. These costs were recorded after management determined that such severance and benefits were probable and estimable, in accordance with SFAS No. 112, Employers’ Accounting for Postemployment Benefits. Other costs primarily represented contract termination costs. The majority of actions and related payments for these restructuring activities were completed by January 3, 2009; the remaining accrual balance is immaterial.

Impairment Charges: In 2007, the Company recognized impairment charges of $23.7 million related to acquired intangible assets associated with a distribution agreement with a supplier of medical products to the Company’s Japanese distribution subsidiary. In December 2007, the Company provided notice to the supplier that it was terminating the distribution agreement, effective in June 2008. As a result, the Company recognized an impairment charge to state the related intangible assets at their remaining fair value. The Company had acquired these intangible assets as part of its acquisition of Getz Bros. Co., Ltd. (Getz Japan) in April 2003. The distribution agreement was terminated in June 2008.

Additionally, in connection with the Company completing its United States roll-out of the Merlin™ programmer platform for its ICDs and pacemakers, the Company recorded an $11.8 million special charge in cost of sales to write off the remaining carrying value of older model programmer diagnostic equipment. The Company also recognized $6.0 million of asset write-offs relating to the carrying value of assets that will no longer be utilized, of which $2.5 million was recorded in cost of sales.

Discontinued Inventory: In 2007, the Company recorded a $14.1 million special charge in cost of sales relating to inventory that would be scrapped in connection with the Company’s decision to terminate certain product lines in its CV and AF divisions that were redundant with other existing products lines. Additionally, in connection with the Company’s decision to terminate a distribution agreement in Japan (see Impairment Charges discussed previously), the Company recorded a $4.0 million special charge in cost of sales to write off the related inventory that will not be sold.

In order to enhance segment comparability and reflect management’s focus on the ongoing operations of the Company, the 2007 special charges have not been recorded in the individual reportable segments.

Fiscal Year 2006

Restructuring Activities: During the third quarter of 2006, Company management performed a review of the organizational structure of the Company’s former Cardiac Surgery and Cardiology divisions and its international selling organization. In August 2006, Company management approved restructuring plans to streamline operations within its former Cardiac Surgery and Cardiology divisions, combining them into one new Cardiovascular division and also implemented changes in its international selling organization to enhance the efficiency and effectiveness of sales and customer service operations in certain international geographies.

As a result of these restructuring plans, the Company recorded special charges totaling $34.8 million in 2006 consisting of employee termination costs ($14.7 million), inventory write-downs ($8.7 million), asset write-downs ($7.3 million) and other exit costs ($4.1 million). Of the total $34.8 million special charge, $15.1 million was recorded in cost of sales. The employee termination costs consisted of severance and benefit costs for approximately 140 individuals. The charges for employee termination costs were recorded after management determined that such severance and benefits were probable and estimable, in accordance with SFAS No. 112, Employers’ Accounting for Postemployment Benefits. Inventory write-downs represented the net carrying value of inventory related to product lines discontinued in connection with the reorganization. Asset write-downs represented the net book value of assets that will no longer be utilized as a result of the reorganization and restructuring, including $4.2 million of trademarks acquired in connection with the Company’s 2003 acquisition of Getz Japan as well as other assets related to product lines discontinued in connection with the reorganization. Other exit costs primarily represented contract termination costs. All actions related to these restructuring activities were completed in 2006 and 2007.

46



In order to enhance segment comparability and reflect management’s focus on the ongoing operations of the Company, the 2006 special charges have not been recorded in the individual reportable segments.

NOTE 9 – OTHER INCOME (EXPENSE), NET

The Company’s other income (expense) consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

 

Interest income

 

$

16,315

 

$

4,374

 

$

9,266

 

Interest expense

 

 

(22,581

)

 

(38,229

)

 

(33,883

)

Other

 

 

(18,040

)

 

(15,343

)

 

2,175

 

Other income (expense), net

 

$

(24,306

)

$

(49,198

)

$

(22,442

)

In the fourth quarter of 2008, the Company recognized $12.9 million of investment impairment charges as other expense. The Company evaluated the fair values of the related investments and determined that the impairments were other-than-temporary based upon the magnitude and length of time that the investments’ fair values had declined in 2008.

In 2007, the Company determined that its cost method equity investment in ProRhythm, Inc. (ProRhythm) was impaired and that this impairment was other-than-temporary. The Company had previously invested an aggregate total of $25.1 million in 2005 and 2006 with a total ownership interest of 18%. The Company also had the exclusive right, but not the obligation, to acquire the remaining capital stock of ProRhythm for $125.0 million in cash. ProRhythm filed for Chapter 11 Bankruptcy protection in December 2007. Prior to declaring bankruptcy, based on its understanding of ProRhythm’s efforts to raise additional capital, the Company expected that the carrying amount of its investment would be recoverable upon a liquidation or sale of ProRhythm. As a result of the bankruptcy proceedings, the Company’s exclusive right to acquire ProRhythm, in addition to other rights, were rejected. The resulting changes in the Company’s shareholder rights in ProRhythm changed the Company’s expectations that the carrying amount of its investment in ProRhythm would be recoverable. Given these events, the Company evaluated the fair value of its investment and concluded that it was impaired. The total impairment charge of $25.1 million was recognized as other expense. The Company also recognized a realized gain of $7.9 million as other income related to the sale of the Company’s Conor Medical, Inc. common stock investment.

NOTE 10 – INCOME TAXES

The Company’s earnings before income taxes were generated from its U.S. and international operations as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

U.S.

 

$

580,816

 

$

550,522

 

$

554,581

 

International

 

 

49,925

 

 

193,783

 

 

166,060

 

Earnings before income taxes

 

$

630,741

 

$

744,305

 

$

720,641

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

Current:

 

 

 

 

 

 

 

 

 

 

U.S. federal

 

$

198,179

 

$

141,997

 

$

144,115

 

U.S. state and other

 

 

26,863

 

 

12,421

 

 

12,121

 

International

 

 

53,070

 

 

37,078

 

 

27,081

 

Total current

 

 

278,112

 

 

191,496

 

 

183,317

 

 

 

 

 

 

 

 

 

 

 

 

Deferred

 

 

(31,698

)

 

(6,229

)

 

(10,927

)

Income tax expense

 

$

246,414

 

$

185,267

 

$

172,390

 

47



The tax effects of the cumulative temporary differences between the tax bases of assets and liabilities and their respective carrying amounts for financial statement purposes were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

Deferred income tax assets:

 

 

 

 

 

 

 

Net operating loss carryforwards

 

$

26,411

 

$

9,524

 

Tax credit carryforwards

 

 

53,412

 

 

45,584

 

Inventories

 

 

106,055

 

 

97,930

 

Stock-based compensation

 

 

45,556

 

 

35,232

 

Accrued liabilities and other

 

 

119,052

 

 

109,047

 

Deferred income tax assets

 

 

350,486

 

 

297,317

 

Deferred income tax liabilities:

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

(2,792

)

 

(8,095

)

Property, plant and equipment

 

 

(132,470

)

 

(92,731

)

Intangible assets

 

 

(190,413

)

 

(192,792

)

Deferred income tax liabilities

 

 

(325,675

)

 

(293,618

)

Net deferred income tax assets

 

$

24,811

 

$

3,699

 

The Company has not recorded any valuation allowance for its deferred tax assets as of January 3, 2009 or December 29, 2007 as the Company believes that its deferred tax assets, including the net operating and capital loss carryforwards, will be fully realized based upon its estimates of future taxable income.

A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

2006

 

U.S. Federal statutory tax rate

 

35.0

%

35.0

%

35.0

%

Increase (decrease) in tax rate resulting from:

 

 

 

 

 

 

 

U.S. state income taxes, net of federal tax benefit

 

3.0

 

2.0

 

2.0

 

International taxes at lower rates

 

(9.1

)

(7.9

)

(6.4

)

Tax benefits from extraterritorial income exclusion

 

 

 

(1.3

)

Tax benefits from domestic manufacturer’s deduction

 

(1.6

)

(0.7

)

(0.7

)

Research and development credits

 

(5.5

)

(3.8

)

(3.5

)

Non-deductible IPR&D charges

 

17.7

 

 

 

Other

 

(0.4

)

0.3

 

(1.0

)

Effective income tax rate

 

39.1

%

24.9

%

23.9

%

The Company’s 2008 effective tax rate compared to 2007 and 2006 was unfavorably impacted by 17.7 percentage points relating to non-deductible IPR&D charges. The Company’s effective income tax rate is favorably impacted by Puerto Rican tax exemption grants, which result in Puerto Rico earnings being partially tax exempt through the year 2018.

At January 3, 2009, the Company had $67.7 million of U.S. federal net operating and capital loss carryforwards and $1.1 million of U.S. tax credit carryforwards that will expire from 2012 through 2027 if not utilized. The Company also has state net operating loss carryforwards of $26.1 million that will expire from 2012 through 2015 and tax credit carryforwards of $80.4 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 $1,025.2 million of its non-U.S. subsidiaries’ undistributed earnings because such amounts are intended to be reinvested outside the United States indefinitely.

The Company records all income tax accruals in accordance with FASB Interpretation No. 48 Accounting for Uncertainty in Income Taxes, and SFAS No. 109, Accounting for Income Taxes. At January 3, 2009, the liability for unrecognized tax benefits was $82.7 million, and the accrual for interest and penalties was $21.7 million. The Company recognizes interest and penalties related to income tax matters in income tax expense. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months.

48



The following table summarizes the activity related to the Company’s unrecognized tax benefits (in thousands):

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

Balance at beginning of year

 

$

95,260

 

$

83,082

 

Increases related to current year tax positions

 

 

5,136

 

 

10,236

 

Increases related to prior year tax positions

 

 

5,043

 

 

7,571

 

Reductions related to prior year tax positions

 

 

(22,667

)

 

(409

)

Reductions related to settlements / payments

 

 

 

 

(1,130

)

Expiration of the statute of limitations for the assessment of taxes

 

 

(80

)

 

(4,090

)

Balance at end of year

 

$

82,692

 

$

95,260

 

The Company is subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. The Company has substantially concluded all U.S. federal income tax matters for all tax years through 2001. Additionally, substantially all material foreign, state, and local income tax matters have been concluded for all tax years through 1999. The U.S. Internal Revenue Service (IRS) completed an audit of the Company’s 2002-2005 tax returns, and proposed adjustments in its audit report issued in November 2008. The Company intends to vigorously defend its positions and initiated defense of these adjustments at the IRS appellate level in January 2009. An unfavorable outcome could have a material negative impact on the Company’s effective income tax rate in future periods.

NOTE 11 – 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 IRS 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 $63.2 million, $54.9 million and $47.1 million in 2008, 2007 and 2006, respectively.

The Company has a non-qualified deferred compensation plan that provides certain officers and employees the ability to defer a portion of their compensation until a later date. The deferred amounts and earnings thereon are payable to participants, or designated beneficiaries, at specified future dates upon retirement, death or termination from the Company. The deferred compensation liability, which is classified as other liabilities, was approximately $108 million and $139 million at January 3, 2008 and December 29, 2007, 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 $25.5 million and $26.8 million at January 3, 2009 and December 29, 2007, respectively, which approximated the actuarially calculated unfunded liability. The related pension expense was not material.

NOTE 12 – FAIR VALUE MEASUREMENTS

As discussed in Note 1, the Company adopted the provisions of SFAS No. 157 at the beginning of fiscal year 2008. The adopted provisions of SFAS No. 157 apply to all financial assets and liabilities that are being measured at fair value on a recurring basis. The Company will adopt the remaining provisions of SFAS No. 157 in fiscal year 2009, which apply to all non-financial assets and liabilities that are being measured at fair value on a non-recurring basis.

SFAS No. 157 establishes a framework for measuring fair value, clarifies the definition of fair value and expands disclosures about fair-value measurements. SFAS No. 157 defines fair value as the price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. SFAS No. 157 establishes a valuation hierarchy for disclosure of fair value measurements. The categorization within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The categories within the valuation hierarchy are described below:

 

 

 

 

Level 1 – Financial instruments with quoted prices in active markets for identical assets or liabilities. The Company’s Leve1 1 financial instruments consist of publicly-traded equity securities that are classified as available-for-sale securities and investments in mutual funds that are classified as trading securities.

49



 

 

 

 

Level 2 – Financial instruments with quoted prices in active markets for similar assets or liabilities. Level 2 fair value measurements are determined using either prices for similar instruments or inputs that are either directly or indirectly observable, such as interest rates. The Company’s Level 2 financial instruments include foreign currency exchange contracts and interest rate swap contracts.

 

 

 

 

Level 3 – Inputs to the fair value measurement are unobservable inputs or valuation techniques. The Company does not have any financial assets or liabilities being measured at fair value that are classified as level 3 financial instruments.

A summary of financial assets and liabilities measured at fair value on a recurring basis is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total at
January 3, 2009

 

Quoted Prices
In Active
Markets
(Level 1)

 

Significant
Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

Trading marketable securities

 

$

107,913

 

$

107,913

 

$

 

$

 

Available-for-sale marketable securities

 

 

22,065

 

 

22,065

 

 

 

 

 

Foreign currency exchange contracts

 

 

418

 

 

 

 

418

 

 

 

Total

 

$

130,396

 

$

129,978

 

$

418

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap contracts

 

 

658

 

 

 

 

658

 

 

 

Total

 

$

658

 

$

 

$

658

 

$

 

NOTE 13 – SEGMENT AND GEOGRAPHIC INFORMATION

Segment Information: The Company’s four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF), and Neuromodulation (Neuro). The primary products produced by each operating segment are: CRM – ICDs and pacemakers; CV – vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF – EP introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and Neuro – neurostimulation devices.

The Company has aggregated the four operating segments into two reportable segments based upon their similar operational and economic characteristics: CRM/Neuro and CV/AF. Net sales of the Company’s reportable segments include end-customer revenues from the sale of products they each develop and manufacture or distribute. 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 reportable segments. Certain operating expenses managed by the Company’s selling and corporate functions, including all stock-based compensation expense, impairment charges and special charges have not been recorded in the individual reportable segments. As a result, reportable segment operating profit is not representative of the operating profit of the products in these reportable segments. Additionally, certain assets are managed by the Company’s selling and corporate functions, principally including end-customer receivables, inventory, corporate cash and cash equivalents and deferred income taxes. For management reporting purposes, the Company does not compile capital expenditures by reportable segment; therefore, this information has not been presented as it is impracticable to do so.

50



The following table presents certain financial information by reportable segment (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CRM/Neuro

 

CV/AF

 

Other

 

Total

 

Fiscal Year 2008

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,955,603

 

$

1,407,648

 

$

 

$

4,363,251

 

Operating profit

 

 

1,824,023

 

 

736,979

 

 

(1,905,955

)

 

655,047

 

Depreciation and amortization expense

 

 

93,397

 

 

38,743

 

 

70,288

 

 

202,428

 

Total assets

 

 

2,018,478

 

 

1,267,290

 

 

2,436,736

 

 

5,722,504

 

Fiscal Year 2007

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,577,975

 

$

1,201,302

 

$

 

$

3,779,277

 

Operating profit

 

 

1,576,439

 

 

579,325

 

 

(1,362,261

)

 

793,503

 

Depreciation and amortization expense

 

 

96,764

 

 

35,731

 

 

65,170

 

 

197,665

 

Total assets

 

 

1,977,174

 

 

769,194

 

 

2,583,036

 

 

5,329,404

 

Fiscal Year 2006

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,235,128

 

$

1,067,319

 

$

 

$

3,302,447

 

Operating profit

 

 

1,337,479

 

 

502,244

 

 

(1,096,640

)

 

743,083

 

Depreciation and amortization expense

 

 

86,563

 

 

33,232

 

 

47,017

 

 

166,812

 

Total assets

 

 

1,893,200

 

 

800,907

 

 

2,095,687

 

 

4,789,794

 

Net sales by class of similar products for the respective fiscal years were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Net Sales

 

2008

 

2007

 

2006

 

Cardiac rhythm management

 

$

2,701,463

 

$

2,368,081

 

$

2,055,765

 

Cardiovascular

 

 

862,136

 

 

790,630

 

 

741,612

 

Atrial fibrillation

 

 

545,512

 

 

410,672

 

 

325,707

 

Neuromodulation

 

 

254,140

 

 

209,894

 

 

179,363

 

 

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

Geographic Information: 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, Japan and Asia Pacific. The Company attributes net sales to geographic markets based on the location of the customer. Other than the United States, Europe, Japan and Asia Pacific no one geographic market is greater than 5% of consolidated net sales.

Net sales by significant geographic market based on customer location for the respective fiscal years were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Net Sales

 

2008

 

2007

 

2006

 

United States

 

$

2,319,645

 

$

2,107,015

 

$

1,920,623

 

International

 

 

 

 

 

 

 

 

 

 

Europe

 

 

1,152,601

 

 

936,526

 

 

763,526

 

Japan

 

 

387,648

 

 

321,826

 

 

289,716

 

Asia Pacific

 

 

234,073

 

 

192,793

 

 

148,953

 

Other

 

 

269,284

 

 

221,117

 

 

179,629

 

 

 

 

2,043,606

 

 

1,672,262

 

 

1,381,824

 

 

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

51



The amounts for long-lived assets by significant geographic market include net property, plant and equipment by physical location of the asset. Prior periods have been reclassified to conform to the current year presentation. Long-lived assets by significant geographic market were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Long-Lived Assets

 

January 3, 2009

 

December 29, 2007

 

December 30, 2006

 

United States

 

$

775,205

 

$

602,352

 

$

492,277

 

International

 

 

 

 

 

 

 

 

 

 

Europe

 

 

84,266

 

 

84,892

 

 

75,267

 

Japan

 

 

16,001

 

 

1,774

 

 

10,059

 

Asia Pacific

 

 

17,087

 

 

7,183

 

 

5,157

 

Other

 

 

87,617

 

 

80,594

 

 

35,091

 

 

 

 

204,971

 

 

174,443

 

 

125,574

 

 

 

$

980,176

 

$

776,795

 

$

617,851

 

NOTE 14 – QUARTERLY FINANCIAL DATA (UNAUDITED)

Quarterly financial data for 2008 and 2007 were as follows (in thousands, except per share amounts):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

First
Quarter

 

Second
Quarter

 

Third
Quarter

 

Fourth
Quarter

 

 

Fiscal Year 2008:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

1,010,738

 

$

1,135,760

 

$

1,084,136

 

$

1,132,617

 

Gross profit

 

 

750,251

 

 

848,069

 

 

810,210

 

 

784,180

 (a)

Net earnings

 

 

184,781

 

 

201,059

 

 

192,943

 

 

(194,456

)(b)

Basic net earnings per share

 

$

0.54

 

$

0.59

 

$

0.56

 

$

(0.56

)

Diluted net earnings per share

 

$

0.53

 

$

0.58

 

$

0.55

 

$

(0.56

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year 2007:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

886,978

 

$

947,336

 

$

926,840

 

$

1,018,123

 

Gross profit

 

 

648,001

 

 

694,313

 

 

681,981

 

 

713,388

 

Net earnings

 

 

145,725

 

 

134,800

(c)

 

160,239

 

 

118,274

 (d)

Basic net earnings per share

 

$

0.42

 

$

0.40

 

$

0.47

 

$

0.35

 

Diluted net earnings per share

 

$

0.41

 

$

0.39

 

$

0.46

 

$

0.34

 


 

 

 

 

(a)

Includes pre-tax special charges of $43.5 million associated with the impairment of a license agreement relating to technology no longer fully utilized in the Company’s products; $13.7 million of inventory charges related to the termination of a supply agreement and inventory obsolescence charges associated with a terminated distribution agreement; and $7.4 million related to the Company providing its remote patient monitoring system without charge to existing St. Jude Medical CRM patients.

 

(b)

Includes $319.4 million of IPR&D charges primarily associated with the acquisition of MediGuide; after-tax special charges of $72.7 million, which consist of the following: $59.3 million primarily associated with the impairment of a technology license agreement and the impairment of purchased technology intangible assets related to the Company’s 2005 Velocimed acquisition; $8.7 million of inventory-related charges; and $4.7 million related to the Company providing its remote patient monitoring system without charge to existing St. Jude Medical CRM patients. Additionally, the Company recorded $22.2 million of after-tax contribution expenses to non-profit organizations including the St. Jude Medical Foundation, and $8.0 million of after-tax investment impairment charges. Partially offsetting these charges to net earnings, the Company recorded an $18.1 million income tax benefit related to the federal research and development tax credit extended in the fourth quarter of 2008 retroactive to the beginning of the year.

 

(c)

Includes an after-tax special charge of $21.9 million related to the settlement of a patent litigation matter.

 

(d)

Includes after-tax special charges of $21.4 million related to initiatives to streamline the Company’s operations, primarily internationally; $14.9 million of impairment charges related to acquired intangible assets associated with a terminated distribution agreement; $11.5 million of inventory write-offs for discontinued products; and $7.5 million associated with the write-off of the remaining carrying value of older model programmer diagnostic equipment. The Company also recorded an after-tax impairment charge of $15.7 million associated with its investment in ProRhythm.

52



Five-Year Summary Financial Data
(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2008 (a)

 

2007 (b)

 

2006 (c)

 

2005 (d)

 

2004 (e)

 

SUMMARY OF OPERATIONS FOR THE FISCAL YEAR:

Net sales

 

$

4,363,251

 

$

3,779,277

 

$

3,302,447

 

$

2,915,280

 

$

2,294,173

 

Gross profit

 

$

3,192,710

 

$

2,737,683

 

$

2,388,934

 

$

2,118,519

 

$

1,615,123

 

Percent of net sales

 

 

73.2

%

 

72.4

%

 

72.3

%

 

72.7

%

 

70.4

%

Operating profit

 

$

655,047

 

$

793,503

 

$

743,083

 

$

612,730

 

$

535,958

 

Percent of net sales

 

 

15.0

%

 

21.0

%

 

22.5

%

 

21.0

%

 

23.4

%

Net earnings

 

$

384,327

 

$

559,038

 

$

548,251

 

$

393,490

 

$

409,934

 

Percent of net sales

 

 

8.8

%

 

14.8

%

 

16.6

%

 

13.5

%

 

17.9

%

Diluted net earnings per share

 

$

1.10

 

$

1.59

 

$

1.47

 

$

1.04

 

$

1.10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION AT YEAR END:

Cash and cash equivalents

 

$

136,443

 

$

389,094

 

$

79,888

 

$

534,568

 

$

688,040

 

Working capital (f)

 

 

1,051,539

 

 

278,954

 

 

1,013,958

 

 

406,759

 

 

1,327,419

 

Total assets

 

 

5,722,504

 

 

5,329,404

 

 

4,789,794

 

 

4,844,840

 

 

3,230,747

 

Long-term debt, including current portion

 

 

1,201,602

 

 

1,387,991

 

 

859,376

 

 

1,052,970

 

 

234,865

 

Shareholders’ equity

 

$

3,235,906

 

$

2,928,010

 

$

2,968,987

 

$

2,883,045

 

$

2,333,928

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER DATA:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted weighted average shares outstanding

 

 

349,722

 

 

352,444

 

 

372,830

 

 

379,106

 

 

370,992

 

Fiscal year 2008 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 2004 through 2008.

 

 

 

 

(a)

Results for 2008 include $319.4 million of IPR&D charges primarily associated with the acquisition of MediGuide, Inc.; after-tax special charges of $72.7 million, which consist of the following: $59.3 million primarily associated with the impairment of a technology license agreement and the impairment of purchased technology intangible assets related to the Company’s 2005 Velocimed acquisition; $8.7 million of inventory-related charges; and $4.7 million related to the Company providing its remote patient monitoring system without charge to existing St. Jude Medical CRM patients. Additionally, the Company recorded $22.2 million of after-tax contribution expenses to non-profit organizations including the St. Jude Medical Foundation, and $8.0 million of after-tax investment impairment charges. The impact of all of these items on 2008 net earnings was $422.3 million, or $1.21 per diluted share.

 

(b)

Results for 2007 include after-tax special charges of $21.9 million related to the settlement of a patent litigation matter; $21.4 million related to initiatives to streamline the Company’s operations, primarily internationally; $14.9 million of impairment charges related to acquired intangible assets associated with a terminated distribution agreement; $11.5 million of inventory write-offs for discontinued products; and $7.5 million associated with the write-off of the remaining carrying value of older model programmer diagnostic equipment. The Company also recorded an after-tax impairment charge of $15.7 million associated with its investment in ProRhythm. The impact of all of these items on 2007 net earnings was $92.9 million, or $0.26 per diluted share.

 

(c)

Results for 2006 include after-tax special charges of $22.0 million, or $0.06 per diluted share, related to restructuring activities in the Company’s former Cardiac Surgery and Cardiology divisions and international selling organization.

 

(d)

Results for 2005 include $179.2 million of IPR&D charges relating to the acquisitions of ANS, Savacor, Velocimed and ESI. Additionally, the Company recorded an after-tax special credit of $7.2 million for the reversal of a portion of accrued Symmetry™ device legal costs, net of settlement costs. The Company also recorded an after-tax expense of $6.2 million as a result of a contribution to the St. Jude Medical Foundation. The Company also recorded the reversal of $13.7 million of previously recorded income tax expense due to the finalization of certain tax examinations, as well as $26.0 million of income tax expense on the repatriation of $500 million under the provisions of the American Jobs Creation Act of 2004. The impact of all of these items on 2005 net earnings was $190.5 million, or $0.50 per diluted share.

53



 

 

 

 

(e)

Results for 2004 include after-tax special charges of $21.9 million relating to the discontinuance of the Symmetry™ device product line and product liability litigation, as well as an after-tax special charge of $3.4 million resulting from the settlement of certain patent infringement litigation. Additionally, the Company recorded $9.1 million of IPR&D in conjunction with the acquisition of Irvine Biomedical, Inc. Also, the Company recorded the reversal of $14.0 million of previously recorded income tax expense due to the finalization of certain tax examinations. The impact of all of these items on 2004 net earnings was $20.4 million, or $0.06 per diluted share.

 

(f)

Total current assets less total current liabilities. Working capital fluctuations can be significant based on the maturity dates of the Company’s long-term debt.

Cumulative Total Shareholder Returns
(in dollars)

(LINE GRAPH)

The graph compares the cumulative total shareholder returns for St. Jude Medical common stock for the last five fiscal years with the Standard & Poor’s 500 Health Care Equipment Index and the Standard & Poor’s 500 Index weighted by market value at each measurement point. The comparison assumes that $100 was invested on December 31, 2003 in St. Jude Medical common stock and in each of these Standard & Poor’s indexes and assumes the reinvestment of any dividends.

54



Certifications
The Company has filed as exhibits to its Annual Report on Form 10-K for the year ended January 3, 2009, the Chief Executive Officer and Chief Financial Officer certifications required by section 302 of the Sarbanes-Oxley Act. The Company has also submitted the required annual Chief Executive Officer certifications to the New York Stock Exchange.

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:

Wells Fargo Shareowner Services
P.O. Box 64874
St. Paul, MN 55164-0874
1.800.468.9716
www.wellsfargo.com/shareownerservices

Annual Meeting of Shareholders
The annual meeting of shareholders will be held at 8:30 a.m. on Friday, May 8, 2009, at the Minnesota History Center, 345 Kellogg Boulevard West, St. Paul, Minnesota, 55102.

Investor Contact
To obtain information about the Company call 1.800.328.9634, visit our website at www.sjm.com or write to:

Investor Relations
St. Jude Medical, Inc.
One St. Jude Medical Drive
St. Paul, Minnesota 55117-9983

The Investor Relations (IR) section on St. Jude Medical’s website includes all SEC filings, a list of analyst coverage, webcasts and presentations, financial information and a calendar of upcoming earnings announcements and IR events. St. Jude Medical’s Newsroom features press releases, company background information, fact sheets, executive bios, a product photo portfolio, and other media resources. Patient profiles can be found on our website, including the patients featured in this year’s annual report.

Company Stock Splits
2:1 on 4/27/79, 1/25/80, 9/30/86, 3/15/89, 4/30/90, 6/10/02 and 11/1/04.
3:2 on 11/16/95

Stock Exchange Listings
New York Stock Exchange
Symbol: STJ

The daily range of high and low prices per share for the Company’s common stock for fiscal years 2008 and 2007 is set forth below. As of February 18, 2009, the Company had 2,690 shareholders of record.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2008

 

2007

 

Quarter

 

High

 

Low

 

High

 

Low

 

First

 

$

44.65

 

$

38.51

 

$

43.46

 

$

34.90

 

Second

 

$

45.77

 

$

39.58

 

$

44.91

 

$

37.26

 

Third

 

$

48.49

 

$

40.06

 

$

48.10

 

$

40.50

 

Fourth

 

$

44.04

 

$

24.98

 

$

47.02

 

$

36.90

 

Trademarks
All product names appearing in this document are trademarks owned by, or licensed to, St. Jude Medical Inc.


GRAPHIC 4 a0907971001.jpg GRAPHIC begin 644 a0907971001.jpg M_]C_X``02D9)1@`!`@``9`!D``#_[``11'5C:WD``0`$````/```_^X`#D%D M;V)E`&3``````?_;`(0`!@0$!`4$!@4%!@D&!08)"P@&!@@+#`H*"PH*#!`, M#`P,#`P0#`X/$`\.#!,3%!03$QP;&QL<'Q\?'Q\?'Q\?'P$'!P<-#`T8$!`8 M&A41%1H?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\?'Q\? M'Q\?'Q\?'Q\?_\``$0@!60*>`P$1``(1`0,1`?_$`,D``0$``P`#`0`````` M```````%`P0&`0('"`$!``,!`0$```````````````$"`P0%!A````4!`P8' M"P@'!@8"`P$```$"`P0%$1(&(3$3E%4602*3TQ05!U%A<=$R4M)3XW0V@4*2 M([,TM-2A8H*R,U07D7*B0R0UL6-S@Z,(1&3PA$4E$0$``@$!!0,)!04(`0,% M`````0(#$2$Q01($46$3<8&1H;'1(C(%P4)2,Q3PX6)R%8*2HK+"TB,&\4.# M)&-SDT06_]H`#`,!``(1`Q$`/P#]$8>P[A]>'Z8M=,B*4J(P:E&PV9F9MIM, M^*`H;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7 M#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O# MNRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`; MMX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT M0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?( M->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7 M#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O# MNRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`; MMX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT M0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?( M->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7 M#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O# MNRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`; MMX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT M0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?( M->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7 M#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O#NRX?(->B`;MX=V7#Y!KT0#=O# MNRX?(->B`GU/#N'TS:214R(1*EJ)1$PWE+HCYV'Q>Z0"AAOX=I?N;'V20%$` M`3<18@I^'Z/)JU0TG18J%+6EEM3KAW2-5B4)(SS%X"X<@"56,>Q:14EQ)M+G M)83'D2RJ"2C*CJ9BLZ9U=A/Z8B*TD6J;+CF1<-H#9B8R@/88>Q$['>C0F26K M1J5'?<62#N\3HKLAM1J5Q2*_;;D.P!N4&NL5B*Z\B._#>C/*CRH;-%XBM*VR\`TIN%T2I=0E*D6.S(+=/9-33;A,I0IQ:E$APEH7I%.%>2I-AW M2`3FL!N=25*FR)Z#55E+?ENQXR64)DDEI#+C#5]:4);)@C-)WKRLIF`KX;HD MBE1Y1RY93I\^0J7,DI:)A"G#0AI)(:)2[J4MM)3E49Y,X#5J5+C/8DADMR02 M)#$A;J&Y4AM!J;-DD'<0XE)6$H\Q`-S=JE^=*UR7SH!NU2_.E:Y+YT`W:I?G M2M8`50```````````````````` M`````````````````!CD/M1V%OO'=:;2:EG89Y"[Q6F?R`B9TC5,1BBF+=@- M-DZM50;0\T9-GQ$._P`,W"SE>L/@R<-A"W++*,]9F(_$R4^OQ9[4M4=E_20S ML<86BZXJU-Y-U)G\XLQ'8?=L":Z)IFBT3I$[&6CU=NJ,./-L/1]$ZIE:)"22 MJ\BR]9=4HC(CR9\]HBT:)Q9.>-=)CRMX0T`````````````````````````` M````````````````````````````!.JGWZC^^+_"2`##?P[2_8`50``````````````````````````````````````, MK2,@'/;FQM+3G"?RP6H[*E&V@UK**HUMFE9E>;XQG>NYRR"_.YOTT:QMW:>K MV-NF4-^%(?D',-YZ0I&E6;2$7FVR5=O$BZ1N&:^,OAL(K!$VU7QXIK,SKO\` MV_:6[3(#<"`Q#0HUDRDDFX>=:LZEGWU*,S,1,ZRO2G+6(;(A<``````````` M```````````````````````````````````````````$ZJ??J/[XO\)(`,-_ M#M+]S8^R2`H@```````E3/B2F>[R_P!Y@!5````````````````````````` M``````````````!Q/:;C:JX68I[E/:8=.6MQ+FG)1V$@DF5EU2?.%+VT>?U_ M5VPQ'+IM.S+&U5Q3'J#E0:9:5$6VELF"41&2TF9VWE*[@4MJ=!U=LT3S:;'; M"[T````````````````````````````````````````````````````````$ MZJ??J/[XO\)(`,-_#M+]S8^R2`H@```````E3/B2F>[R_P!Y@!5````````` M`````````````````````````````$>NXGA4I;<5"%S:K(+_`$M-CV*>7^L? M`A!<*U9!$SHPRYXILWVGA"0K!"Z^I,S&"BDN$1]&ID=:T1XQ*S\9)I6XL[,J MCR=PA7EUWL)Z3Q=N7;W<(][6*DQESWSOOO*[JUGP=Q)9"$Q&C;%@K3=OG?/&502V>'&T.(4VXDEMK(TK0H MK2,CR&1D8$QJY*"XO"51;I4A1GAR:N[2I*CMZ*\K_P"*XH_F*_RC/^[W!2-G MD<5)\&W+/R3N[N[W>AUPN[0````````````````````````````````````` M`````````````````3JI]^H_OB_PD@`PW\.TOW-C[)("B```````"5,^)*9[ MO+_>8`50`````````````````````````````````!H5JNTRC12D3W;A*.XR MTDC6ZZL\R&T%QEJ/N$(F=&>7+6D:V0DTFLXF43M>2JGT8\K5$0KZQTLY',<2 M>;_E)R=TS%=)G>Y_#OEVWV5_#_N]SJ6&&6&4,L-I:9;(DMMH(DI219B(BR$+ MNN(B(TA[@D``&O4:=#J4%Z#-:)Z+(2:'6U<)'_P,N`Q$QJK>D6B8G=*!0*C- MI<].&JRZ;KMTU4>H+_\`E,I^8L_7-%Y7G%QNZ(B=-DN;#>:6\._]F>V/?#IQ M9U@````````````````````````````````````````````````````"=5/O MU']\7^$D`&&_AVE^YL?9)`40`!CDR8\9AR1)=0Q'92:W7G%$A"$I*TU*4JPB M(N^`T7L38<8J1TQZJ1&JBELWU0UO-I=)I*36;AH,[Q))*35;W`&6'6Z--IIU M2'/CR*:25*.:TZA;))1;?,W",TV)LRY<@#)3:I3:G#1-ILIF;#7^\P`J@````````````````````````````````. M=JF*7#FKI%`8*HU=.1XS.R-%M^=(<+A_43QC[PK-NQS9.HV\M(YK>J/+[F6B MX6;B2CJE2?.IUM96*FNE8EM)YVX[>9I'@RGPF$53BZ?EGFM/-?M]W8NBSH`` M````!.KU#BUFGG$?-3:TJ)V-);R.,O(RH=;/@4D_$(F-66;%%ZZ3_P"&EAJN M2WW7J/5R2U78)$;Q)R(D-'D1):_55PE\U601$\&>#+,_#;YX]??"\+.D```` M```````````````````````````````````````````````!.JGWZC^^+_"2 M`##?P[2_1$;=LN:E27)IJB26TQ4M%'5$,C)M:G&T6N$D[$V\8[3 M2`W5X?Q%/P[B%ARGHA2JZ\N8U$4\VM#9M-QVD,.K01E;(T"C4:2416Y0%[!\ M"I1V:G+J$5,!^J3ES"@I<2Z;*3:::(E+05PU*-DUG=M\K.`QU2+6%XI@*8GM MLMJCRM$A4>^:2(V+2-6D3;:?>`;W0<1[59U3VH!T'$>U6=4]J`=!Q'M5G5/: M@'0<1[59U3VH!T'$>U6=4]J`=!Q'M5G5/:@'0<1[59U3VH!T'$>U6=4]J`=! MQ'M5G5/:@'0<1[59U3VH!T'$>U6=4]J`=!Q'M5G5/:@'0<1[59U3VH!T'$>U M6=4]J`=!Q'M5G5/:@'0<1[59U3VH!T'$>U6=4]J`=!Q'M5G5/:@'0<1[59U3 MVH!T'$>U6=4]J`=!Q'M5G5/:@'0<1[59U3VH!T'$>U6=4]J`P3NMX$5R7-K< M:/&:*\XZY&)*2+PFZ$RK>\5C69TA!CEC+$[3J&YZJ90W$V-S>CZ&8_WVT&M6 MC;/SCL4?!8*;9N?)V1ZUJEXU`.@XCVJ MSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4!*K6%J].4Q M-:JC2*I`-3D%],:YQC*PVUJTBK6UYE%8*S&K#/AYML;+QNG]N#QAZHUZKQ7# M54&HL^*O0U""N+QV72+*7\7*E6="N$A,3JG!FYX[+1OCL5N@XCVJSJGM1+8Z M#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(] MJLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJ MGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U` M.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B M/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JL MZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM M0#H.(]JLZI[4`Z#B/:K.J>U`.@XCVJSJGM0#H.(]JLZI[4`Z#B/:K.J>U`"@ MXBMRU5DRX2Z+[4!DJGWZC^^+_"2`##?P[2_9M!<*U9!$VT89<\4V1MM/#]MS2@X7ESI3=4Q0XB7*;._%IK=O0XQ\!DD M_P"*X7GJ^0B$17M9TP3:>;)MGA'"/?/>Z86=8`````````````YW$='FMRT8 MAHB2.KQDW)$:VZF9'+*;*_URSMJX#R9C%9CC#ESXYB>>GS1ZX[/[R_WF`%4``````````````````````3GJXPW-E0TL/NR M(K"9"DH1D62S-));-1I)2LF7@+A,6Y64Y8B9C2=8A/:QM2W"IY);<-=1,R0@ ME,F:22YHK;=)8X1K+)HKUI9_;YM6_)K+D>KQJ<<%Y:95N MCE)4SHRNI-2C-)N$Y8G(1G0B(N$Q5JY9[$%4KSJX>%[&X:3-$FON)O-)LR*3%0?\`&7^MY!=\5UUW..J+N(J67SD]\A6=FUQY:SCMXE=WWH^WW]KIHLJ-+C-2HSB7H[R26TZ@[4J2HK2,C% MG76T3&L;F4$@````````````````````"9B3$E&PW1I-8K$A,:!%3><<5G,_ MFH0G.I2CR$1"MK1$:RTPX;9+16L:S*7@#M$P[CFB]9T9TR4@[DJ&[83["^`E MI(SSYTF60_[1%,D6C6&O5=)?!;EL@UF!C)G#;/,;V5XGPXC6L^C9^W%6HD.9'K==6\M]R. M^\RY&4\HU)L-DB4EK@2E*LEA?\1:(VRRR6B:U6Q9B``````````````````" M=5/OU']\7^$D`&&_AVE^YL?9)`1.U)AZ1@V5&9GE`>D.QV6U*4^@GE./H04< MUQ?KTD\9W#-O*5OQAV1'J,],Z?'FOLRD-G(4B.XW=2IA"I))=4F MTKY'82>-Q>+8`[$````!*F?$E,]WE_O,`*H``````````````````````T95 M(;?DNR4ONL/NL%')QHR(TDE9K)2;2/C6GPY.\)B6=L>LZZZ;$X\&P5$T:Y#R MEI4:I2[&B-^\Z3QDJQ'$+2%;]7=%N=E^FC9MGW\?VT>]6G4JB.IJE1DKN/XK3MW?^$]-&K&)5$_B$CA M4G(IFA-JXSA9R.8XGRO^FG)W;1337>S\*V7;?97\/^[W.J:::9:2TRA+;2") M*&T$24I(LQ$19"%W7$:;(>P)``````````````````!R"K<'5`UE\*SW..7! M`D.'G[S#BCR^:KO&*;O(XOR+?_3G_#/NGU.O(R,K2RD>8Q=V@#2K-8A4>F2* ME--?1HR#6X3:%.+,BX$I21F8B9T7QTFTZ0UUXDA-UQFCK:>2\^VIQI\T$3)W M4WU))5MX[JJ=/COS6VG7&4LM)2EUP MVG-&9MDXIM)I.R\1F96IRAS;-2<4Q;EF8AGH57:K%*8J3+#L=J02C0U()*7+ M"4:25Q%+38JRU)D>4LHF)UA7)CY+::ZM\2H``````#'(DQHS1NR'4,M)RJ<< M42$EX3.P@3$3.YRU0[6>SF"Z;#E?BOR"R='AJ.8[;W+D8G56_(,YRUCBZJ=# MFMMY9\^SVM7^IDJ7DH>$ZW4;?(>=CI@,G^W,6RJS]D/$[(E;]'$?->D>?7V: MG6';#/\`NU'H]$;/AG2GIKI?]N,AI%O_`'`UO/"(.3IZ[[6MY(T]ON-S)U[I3GZ0Y+3OD_48J_+C_O3,^YIU?L,P;6:>]&JTBI MU*2XDR:G39TA]QE9ED<;0I6A(R_N6")PQ,;5\?U+)2VM8K7NB(_\N?[-L(1> MR?$*:'-4B5&Q*2$P,0&WHE=,:2=Z"Z5Y1))96K9RY3O%E.P4QTY)T[6_6=1/ M55YXV33?7N[?>^QCH>0``````````````````````"=5/OU']\7^$D`&&_AV ME^YL?9)`<_VM/-LX'EK7';D%IHJ2-U4E!,FJ0@B?)4,CDDIKRRT?&R`/7LF1 M'3A(C96PZ:Y+RG7XYS5:1PS*\MQ=0MD+6?":CLS$60!V8````"5,^)*9[O+_ M`'F`%4``````````````````````>KRC2TM19TI,R^0@1.Y\.HW:SCRH56'! M;7#-R4\AE)+9-*;5G9QC2JVSP#"+R^>Q?42TCO%GX3&L5>UBZ>*SS6GFOV^[L7!9T`````````````` M```````#')CL28[D>0VEUAY)H=;65J5)45AD9`BU8F-)W.8I$A_#=1:P_/<4 MY2Y)FFA3G#M-/#T-U1_.27\,S\HLF5!2VI M!0T$EM1*6T;*C3(027DI4A65)*\K+WA$UU:TS\L;(V_MPW/,'"*8%)ETR-4) M.@F'*4XX\M3[Q*E%81I<<-2BT?!W>$(KI&A;/S6BTQ&S3NW+D=IB.RU&9(D- MM()#;99+$((DE87<(68S,SM9`0TZC6:/3&]+4IT>$WY\AU#2?[5F0B9B-Z], M=K?+$RY=[MB[/B<4S"J*JO(+(3-+COSE&?>..AQ'^(4\6KICH,V^8Y8_BF(] MKTW^Q1-_V7!%3=+@=J3D>G(\-CBW'?\`QASS.Z$_I:5^;)7S:V_=ZR[VRS\Z MZ'0FE>:4FHOI_MZ(W;_:'QSV0?\`QZ_CMZ*^\_I]B.;EK>-JM((\[5/*/36_ M!]2A3O\`Y`Y)XS)^JI'RXZ^?6W[O4RQ^Q_L\0Z3TJE=:2"RF_4WGIRC/N_ZE M;A?H#PJHGK\VZ)Y?)L]CJ*?2:73FM%3X;$-HLA-QVT-)L\""(A>(B'+:]K;9 MG5DDS(D4FSDO(:TSB66KYD5YQ9V)0FW.9F+1#.UHC>U%XBH:%2TKF-DJ%9TD MK3XMIW;/UCO<7BVYFW;N>SU>I#5.;J2Y*>A.F1-/)(U7C4=A$1) M(U6Y,U@2NTNX*TMPG?#;J<41I>GR6]4]G[<'7#1R``` M``````````````````"=5/OU']\7^$D`&&_AVE^YL?9)`1.U!,->$'D3)[]/ MC+D14NKBIDJ?=2;Z"-ALHEDB\[Y)7/ER6@-+L:@28.#M"^^](5TETTKD,SF' M+I$E)7DU#_4&:KMX_FY;$Y"`=R`````E3/B2F>[R_P!Y@!5````````````` M`````````',UBLSZE.L"*0KC^GXJS M$Q&V'5"SM````````````````````````:=7I$&KT]Z!-1?8>++8=BDJ+*E: M%?-4D\I&(F-5,F.+UY9W)&':O.CS%8=K:[]382:XF9[>WSOLO],% MR\MF-)OR")3JC<):M*V3;EIZ2];9E.W)PA% MHU+8;32(V;.^?:\U[%4#"%(@JJRGY9KNQ],TE*EK<0BTUJ)2DY[O=&=K1!FZ MBN"LO&-\/4Z;+$:TO\` M);U=_F6,+XDIV)*'&J\`U$R^1DXRLKKC+J#NN,NI^:MM9&E1":VUC5EFQ3CM M-9519D````````````````````G53[]1_?%_A)`!AOX=I?N;'V20'+=M3L=O M`,A4B0W&8Z7`)QYYYV,R1',:+ZU]BQYI%OE+0=J'W=$3)W*K6$Y4Q^ZTSP*?,OD1PY169UV0Y,F2UYY*> M>W9W1W^Q4S,3$:-\>.M(TAN"6@`` M````````````````````````)6(J`U6(24$X<:='43T":CRV7DYE%W2/,I/" M0B8U8YL,7CLF-T]DN6;[68#!KH\B(_4,81E&S)HE,0;ZS4DB^MOVDVVTJTCO M.**S,*>)&[BZNDZ?)DIS7CDB.,[(\W;YGL=![0L4%>Q!4"PU25__`,>D.7Y: MT^;(GF17>^3*2_O".6T[]CJ\7%C^2.>W;;=YJ^]T^'<*8=PY$.+18#4)M1WG M5(*UQQ7G.N*M6XKOJ,S%ZUB-SFRY[Y)UM.JJ+,@```````````&G4ZS2:6SI MJC+:B-\!NK)-O]TCRG\@B9T4R9:TC6TZ(N]\^?Q1-2>:;*_T<;PDIPM( MLO[J!'-V.?\`4S;Y*S/?.R/?ZD+%N`L88HB,)GU6(VIIPW$Q&F5DRBU)E:3A MF;BU9>&PN\*VK,N?J>CRYHC6T>31K85P;BO`ZI,N.3%8CR"04J(S>;D76[UB MF37Q5&5X^*>?NA6LU4Z?I2K`N)7,4QR,L+5EQ",3L)+BQ9)V(;J*2+,E6 M1#_R*X#&<_#.O"=[U,?_`#TY)^>OR]\?A]WH?04J2I)*29*2HK4J+*1D?"0U M<#R```````````````````"=5/OU']\7^$D`&&_AVE^YL?9)`0.TZKG%H)P8 MTQ$>I3%M&TPEV.U*=CI?:1(*(J5]3IKKA$B]PF7"`R=F*:JG#1E4#>,BD.]" M*6N,[+*-DT92EQ+63=SYCMLLO<:T!U@````"5,^)*9[O+_>8`50````````` M``````````-B"PK1U:LH^:?SF(QYC=\Y69'A%)G79#CODG M)/)3=QM]D=_L=#2Z7!I<%J#!:)F,R5B$%_:9F9Y3,SRF9YQ:(T=./'%(TC&4HS,CRBW)$;GF]9XF68OK\==WN\BWA^NQ MJS`Z2TE3+S:C:EQ',CC#R,BVUEW2_2646B=48+(?]U!! MI,GAY;_-;EC^'WS[FY3,'8>I[W26XI/S?G392E2'S/NZ1TU&7R6!%8:8^FI6 M==-O;.V5H6;@``B5K"L2H2$U",ZNG5ELK&JE'L)=A?,=2?%=1^JK]`K-7/EZ M>+3S1\-NV/VVIQU]R.E5&QG%::;EI-A-025Z!)2LKIH7>_A*41Y4+R=PQ&O" M5:=3;',1D^&>%HW?NE-P=+D85K98$J3JG8#B%/80GN':;L5&5<):SSNQB\GS MF[#X#%:3RSRSYGL9XC+7Q:[_`+WE[?)/M=\-7"``````````````````"=5/ MOU']\7^$D`&&_AVE^YL?9)`4E:5 M7BR&1D9`-[M!Z9&??/0M$J&HVVF(C:5.+<0HTR%.H2:DD1D9Y;I!F MI]>E-=GU83"FJ?F1S=Z-4FI3TW3L)2T;TF*N0;KBDLI>-)^41+2=@#H^SZ84 MJG5#H\YVITMF0LY@,M4F55O%,%+-. MTZ$QY6C(<3D[`I$-;% M.9<-FISVWVR4X1>4S%=\FW@6O@X,HIKKN<5KSEGEKLIQM]D>]=IZJE3X;4*% M028BL)N--(D-$1$7_P"9Q>(==*16-(V1#8ZRKVQSUEH%CK*O;'/66@#K*O;' M/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;' M/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;' M/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@#K*O;'/66@`ZG7B*TZ/819SZ2T M`Y5_M8-ZI+I-"HKU?JB+2=13WVG(["N`I,K(RUX+35WAG.2-T;9=E.CMIS7G MDKW[_-&]I2,-=H>(EK/%YFFFF?%H-&E%&CJ1W),D[LAZTLZ4W$B.29^9;]1C MQ_EQM_%;[(W1ZW54>,]18*(%)PTU!AM^2PPZRVFWNF22RF?"9C2(B-SDR9+7 MG6TZRW>LJ]L<]9:$J'65>V.>LM`.?JK6(X=5WBIM(4ATD7:K$2^VHI3""M*Z MDO\`.1\P^',*S'&')FI-;>)3?QCMCWQP5Z;B2HU*"S.A4PGHKZ;S:RDM?*1E MP&1Y#+@,3$ZNC'>+UBT;I;/65>V.>LM"5SK*O;'/66@#K*O;'/66@#K*O;'/ M66@'J[5ZRRVIQVE$VVDK5+7*:2DB[YF")G3>BH[1C?E=%I](>JCA'8M4!QMY MM!_KN\5LOI"O,YIZNNZNMY[O?N>)CO:9.=)*(S%*A**T]`ZV_*R_--3J2:2? M?(E!ME&F:^^8I'IGW/2)A@F7RE2J&Y5)I92E5"8W(67]U*BN)_920V.>LM`'65>V.>LM`(-9[3Z-1 M%&BK.P83I?Y+D^/I3\#2;5G\A#OZ?Z7U6;\O'>T=NDZ>GB<<0A5Y2KI7B3D*W*1V#Z?_`*]]!QQU M,1URI+T!4EY#4ER. MJTEF5\K74(6GRLMEMA\`?]R^DXNGR5O@KRTG9;3Y8GAY)F.!T^29C27V7K*O M;'/66A\2Z6.3)JTIAR/)H27F'2NN-./M*2HCX#(RL,$6K$QI.YPF)<$8F?IB MHE+BN-PV%%+I[+DE#CT&4UQFGH+FFS8RP6R=-;FI\5. M-)[.Z?LE8P%VB5?$5.<9?I&CKU,44:LPU/(:6AXB+CI;7QR;V.>LM`'65>V.>LM`'65>V.> MLM`'65>V.>LM`'65>V.>LM`'65>V.>LM`'65>V.>LM`'65>V.>LM`'65>V.> MLM`'65>V.>LM`'65>V.>LM`'65>V.>LM`/)5*O6E;1S(N[TAH!DJGWZC^^+_ M``D@`PW\.TOW-C[)(#Y_VZXK12:;%IZ/MEU$.'%A16H MD1I+$9A)(::05B4I+@(A=UUK%8TC2._?YH82P#B#$1D[CJKG(BJR[NTLUQH!?JO.6D_)_:- M*?U1'),_-*WZJF/\JNW\4[9\W"'9TVETVEPVX5-BM0X;16-1V$);;27>2DB( M:1&CCO>;3K,ZRV1*H`T9]4Z)+@Q]`MPIKILZ8K"0V9(4OC6G:=MRPB(A,1JS MO?28C3>G3,5E';E'T31KCRTPT])=0PV9J:)W2+(W$4>-5H<,Y,5YHGW+SB6C2V9$9$5MZ^XJ]8E)9SX2$17;H MM;-\,6B-82Z@VYA6H.5F*A2J!-7?K$1)6]'<5_\`+;27S3_S4E_>[HRG8QO' M@VYX^2?FCL[_`'^EUC3K;K2'6E$MIQ)*0M)VI4DRM(R,N`Q=V1.NU[&9$1F9 MV$6S6!*6ZXEZLO/U MN0D[2.:N\T1_JL)NM%]$.7M3'25G;?6\]_NW.A9999;2TRVEII!6)0@B2DB[ MQ%D%G3$1&YZRI<2(RI^4\W'93E4ZZHD)+PJ49$+TQVO.E8F9[DS+DIO;!V>L M/'&C54JK++(46E-NU!PS[G^F2Z1?*8]7']`ZNTV\Q2/\6C.0I-8?8IR"[^C(WW_\`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`'SKM2P?.6['QGATW6<04A-DI$4R2[+@YW&B(\BG$>6V2L_D\(RR5^]&]T M8^7)7PKSRQ/RV_#;M\D[I4*!C])P(4JKJ;=+'`I M?SLQ9!3?Y'%,SGG2-F/M_%Y.[VNLCQX\9AN/';2TPTDD-M((DI2DLA$1$+NR MM8B-(9`2``````````````````#$<2,$FU*)2D^`S21AHG MFG33@T7\,4!]$9#T)M:(CBG8Z3ML2M:KZN'*2E\8TGDM\`CEA>,UHUTG>]9% M!PZB4W5I,=I+\.^XF4ZH[$7E*<-2C4=WBJ6HTWO)MR6".6-Z8RWTY8XN))*%7'*@E6@I;*N&_+41DX9>:R2C%?$U^7:Z(Z/EVY9Y([/O>C MWO5'9W4JZ9/X\JRJLFV\5#AWHM+0=MMBD$>ED6=UU5GZHB&Q.Q!@?"D8F9E0I]&93Y+"W&F/[$6I,_D( M=O3?3\^;\JEK>2)EO')2-(TA$_J[0I>3#],JV(3/,N!!=)FWWB03#-G?O#T? MZ#EI^=?'B_FO&O\`=KS3ZD>+'#63KGM=J62#AVG4)L\SU5F*DNV'_P`B&F[; MWM,'Z?Z?C^;+?+/\%>6/[U_]IK>>&AN1CBH_[YC:4AM6546BQF("2[Q.K*2_ M_C(/ZETN/\KIZZ]N2TW]4>J"S/N MV25.(+Y$BE_K_5S'+6WAU[*1%/\`+$$8JNMAP8,)A+$*.U%83Y+3*$MH+P)2 M1$/)R9;7G6TS:>_:O$:,XHD``&C/I#,R0B2;SK$AJ._&:=941*0F3C/@Z_9 MEF,74?CW5O\`SQ]V?XHV=L,M)KNVP[+#V(Z+B&EM5.CRD2X;N2^FTE)47E(< M0=BD+3PI41&0\?J^DR]/>:9(Y;1^VL=L=[2MHF-84AS)?.GV6L#8E6AY"58& MQ0_=>;61&U`J3QV92/(F/+//P)<[A*&7RSW2[IB.HQZ3^96/[U??'L6E4"L8 M?4;^&5=(I]MKM!D+L07=Z*Z=NB/]17%\`OI,;GB^#;'MQ[:_A]W9[%:AXEIM M8)Q#!J9FL9)4!].CD,GW%H/@[BBR'W1,3JVQ9ZWW;XWQQA5$M@`````````` M``!.JGWZC^^+_"2`##?P[2_PJR1O1.I;<,D M9B6HK59P'4@````)4SXDIGN\O]Y@!5`````````````>KCC;;:G'%$AM!&I: MU'81$64S,SX`)G1R)G(QH[8DUL81;5E45J'*B:3S%F-,?]*_`*;_`".';G[L M?^;]WM=N.NR8B9^'73SZ<&OB M+&-7C4.C3V'4M/R8IR)##9,*6N03+;C;)H?6DR;7?5>N6N>38(M:=(6Q8*S: MT3PGOW=NS_P[U)F:2,RL,RM,NX-7"\@```````\*4E*34HR))9S/(0"'4\>8 M)I=I5&OT^*HLZ')+25Y/U;U[]`K-ZQOEO3ILMMU;3YD8^V/`SIFFFORZNYP) MIT&7)(_`M#5S_$*^+7@V_098^:(KY9B/M>/ZA8AE?[3@>LO]Q4WHL!/_`)GK M_P#A#Q)X1)^EI'S9*^;6?9#F>TA_MRJV#Z@W2J1#HY&@S?;CS52I[C-G'0S= M9;;2HRSV*MX$Y13)SS&R'3T<=+3)'-:;>;2//M1^QCLVK]8PS&D]HJI$VF,I M05!H4MUPFT-%:>DD,<5*[;2T9.6V%P66"N'',Q\3;ZCUE*7F,.D3]ZT?9/N? MXF7)3.V#LZCOG&9K"*E++(4:F(=J#A MGW+(J7?TCU?5I7_$CGF=T/S[2NS3MS5VOIJ+C,F!.7,- MZ172L>B-LJ5:JZI5B'4D@[$MV=ZPN#[W/]7^E1].Y(Y;5Y=(INMK[8G7[WGU M_B1SE=!C'WM#"*/D\*C'P7];Y/R<6+'W\O-;T MWYG7X>N^9E7HG9U@6AJ)RET*%&>S]()E*WC/ONK)3A_2''U/U;JLVS)DO,=F MNST1L3&.L;H=$//7````````````````<9B'`D^IUFD8>HCQ,/#\=/Y)_P!,[)[F=J;=8WMK"F/( MU7EN46IQE47%,9-Z51I"B-2DE_G1G"L2^R?GHS<)$,NN^F6Q5C+2?$P6W7CV M6C[MNZ?,FM]=D[)7:Q2*=6:7*I5293(@S&U,R&59E)47Z#+.1\!CRIC6-);8 M\DTM%J[X4]5*:WI:34',\^G6W4.&?"\SY#I>!7"*4G3X9 M=/4XXM'BT^6=\=D^Z>#H:YAFG5ZE5I&+S&KS MEHQ%5:"M,?%*"7#,[K->829,G;F*2V5ILJ_6\CP"-=-[&,]L M>S)N_%P\_9['4-N-NMI<;42VUD2D+29&1D>8R,A9UQ.KV!(``````````)U4 M^_4?WQ?X20`8;^':7[FQ]DD!S/:[1YM1PPRQ5R2[@]QZ5&=C2G)CRI&G0````'A2$ M*-)J21F@[4F96V'99:7R&`QO0XC[:VGV&W6W#)3B%I2I*C*RPU$993*P@T3% MICWRQ,^9SSO;)V<)6;<:KE47BR:*G MLOS5&?<+HZ'"_2*>+7M=$?3\V^:Z>72/:]?ZF2I.2E80KTVWR5N140FS_:EN M,G_A#Q.R)3^CB/FO2//K[-3K[M8F9(F%8-.(\SE1J5\R\+<5EW]\.:_8>%@C M?>9\E??)U3VOS#_U.(*32DG\V#`=DK+]N2\2?EN?(&E^V#GZ>-U;6\MM/9!_ M3JM2LM6QK6Y)\*(JX\!']D=I*_\`$'ASQF3]76/EQT\^L^V7DNQS`*SOSX;] M5/Z9CO$VK:W+RQ-= M=-?O;]NWY=U=NW716;S"Y6:W5*?6J:PF,VNERW$L/R#-R^AQRTD&9I2;:"O7 M4E>/CJ585EF7AZ?IJ9,5YUGGK&L1LW1ZYX[MT0O,S$KHX5@``#,DD9F=A%E, MSS`.9K':9V?T=S15"OPFY%MG1D.I=>M[FB:ON?X1Z73_`$;J\T:TQWF.W32/ M3.D*3DK'%,_JETW)A_#%;K%[^&_T7H4<^_I9JH^3P),=7]$Y/SLN+'W)V1)T[MDJ7W>F4?#[1_.F2'J@^7_`&XZ6&K?^X8>'].Q[[YF MW-/J-;SV0;A8NG_[[CBH+2>=BDLQZ:WX+Z4O/?\`D#^J=/C_`"NGIY;S:\_9 M7U(Y)G?+-%['>SMIXI$JE%59193D55UVH+,^[_JENI_L(4O]?ZR8TK?DKV4B M*?Y8A,8JNLAP(,%DF(4=J*R69IE"6TE^RDB(>3DRVO.MIFT]^U>(T9Q1*)/5 M4DXKI9-R'"@.QY1/1DI+1Z1&C-"UJLMMRF1%;9G';BBD]/?6(YHM7;QTV[%9 MUU<979^*H](92,HC2=`VORRM)!&FX=A7KV8_9Z;%@ MMDGX:_)39LF(UCXI^*>''CV:<,[3.BWB/$%:*L4>-3X3+G(<72=+B\.]KVKS, MT`````````````````$/%>#J+B:(VS/0MN5&5I8%1CJT4N*Z69QATN,D^Z68 M^$C'=T/U#+TUIFFVL[+5G;6T=DQ^WFSQ M2=)VTMLF/VXQP;&"\5LXDHQ2S:.)4(ZU1:M3EG]9%EM9'6E>`\J3X4F1A2VL M(ZC!..VF^-\3VPNK0AQ"D.)):%$9*2HK2,CSD9&+,)ARSF&ZI0W%2<*K3T8S M-3U!?491U6YSCKRFPKO>1WB%=--SCG!;'MQ[OP\/-V>Q3H>)Z?5E.1R)<2I, M%_JJ;(*X^WW[OSD]Q2;2$Q;5KBSUOLW6CA.]7$MP````````!.JGWZC^^+_" M2`##?P[2_%EU$X3DV7"4DHR4/36TMD\M*7'5M0'&WGDH25 MZXFT\F2S*8#)V12T2L):1N&Y#9*2X3275RUJ6FQ)W[)IJ?1E,TW5'9DM3D,@ M':@````)4SXDIGN\O]Y@!5``````````&*7+C0XSLJ4ZEF.RDUNNK,DI2DLY MF9@K:T5C6=SE6(LK&#Z)E0;7'PRVHEPZ>X5U?+.37"AL\^=7<%-_D< MD5G/.MMF/A';WSW=SKR(B(B(K"+(1$+NT`````>KKK33:G75I;;05JEJ,DI( MNZ9F"8C5R,[M9P/'D*B0YJJS/+)T*D-.3W;>X>@):$_M*(9SEKY757H1-KLE*5V=WHD32K^13B0YK3NCTK>#AK\U^;N MK'VS[GRBG=AG:D?:NY5JAB!U$=:=/)Q)$7HWG$K*ZJ.VV9JN'\VPR-"4V'WA MSQAMSZZO5O\`4\'Z?EBNW\,^U]8_I!A-\O\`_5?J=9/AZ?4ICI'^PEQ"/\(Z M/"CCM>5^OR1\O+7R5A3IO9MV?TTR5"P[3FG"RD[T9I2_IJ2I7Z1,8ZQP97ZO M+;?:WI="TRRR@FV4);;+,A!$DB^0A=A,ZO<$````````-272:=,6MD:5G328GSQNE$PXS'+_9G@?#T:H5V.:8<9XT MPV4*==>>>=/2*2=J[7K;EY6E4:D[6^?;#A>3DH42IXB5W:9`?<; MY=U+3/\`C&']`SU_-MCQ?SWK$^B-;>I/BQPVF\G:G4:T[H-U^TZHY:KC!NG-J\N-18+;9D7< M)^6J2OY220?K>AQ_EX)O/;DO/^6O+[4DLG^F8; M:,_":"(S'F]1UN;-.N2]K^69E:*Q&Y3',L`````````````````````````` M````#%+B19D9V++91(C/I-#S#J26A:59#2I*K2,C%\>2U+1:LZ6CC!,.`71\ M2X`,W\.-O5S"!':_APU7YD)/"JGK6?UC9>H6=OF'P#WHZC#U^S-,8^HX9/NW M_P#N1PG^.//#+2:[ML-.H5FG,OM]I^$G>G4IU*8^+83)'I%QVLA2#:,B4F3# M^UL4ZHQZA&3)CDZ32O)TS3C"C MX;22ZE"K,N>P1,:+4O%HUCW>ULB%P!.JGWZC^^+_``D@`PW\.TOW-C[)(#A^ MV+!&),3=7KHL6+*=B1IK;*I4A<8XLQ_0]&FLFEMZUUC1+NYC*]D,!T^`Z.[2 M,/(A/4MFDNDXXMQAF4N<;BEG:IYV0XAI;CCAY5&HK>^`Z(````!*F?$E,]WE M_O,`*H```!F1%:>0BSF`DN8JH2(K2Q%82:W75G8E)$(F5KWBL:SLAS,2#,Q5):J56:5'H3*B< MIM)<*Q3YEE3(E)_2AL\V:VRG".WOG[(=:+NT``$:O8TPGA]-M M:J\6"H_):==23JO[K9&:U?(0K:\1OEMBZ?)D^6LR@?U+EU'BX6PQ4ZP1^1,? M;*FPS+ND[+N+47]ULQ7Q-=T-_P!'%?S+UK_BGU>\ZM[6ZOEF5:GX:CJ_R:>.AS]/3=%KSW[(]$>][-=D6%7G$O5YR9B62D[275Y M*Y#9'WHY7(YXUFVC.+GL;?^OT3%5'Z-,Q/5Y-1:5I( MTN>\F0RA5EA_Z9!,-E>[J;#[X]#Z=_VJW2Y.:N''%)WQ6-)_O3K*E\'-&^5; MLO[%,+X&I6A6TS5JLXX;KU4?CMDX1V$1(:MOJ0@K,U[/E'+]:_['GZW)KK./ M'IIRQ:=/+/;*V/#%8?0R(B*PLA%F(?/-0``````````````````````````` M````````````'&8DP"\JI.XBPG)12,2K(NE$M)J@U!)?YHCQ,/#\5.^D_Z9V2SM3;K&R7%=G&-TX]]H'$XP!X4E*DFE1$:3*PR/*1D8#X!B_L[Q.YB.J M+I=%4?&M(\F87YF,8)C2-=FS7S-Y-'=33Y472(4Y.HZZ5$<96INUQPW":CH4VRWQ4INMH4IPRMNWCRYS,+ M6U,.+DC3V;E05;`"=5/OU']\7^$D`&&_AVE^YL?9)`40```````2IGQ)3/=Y M?[S`"J`````YV;A:4ZPIN/,0TIQ4U+JEM&LM!.7?6E)$M%BTV%=5F[PO%W+? MIYF-D]OHLS10SWM:!39V(YC57K;2F*:RHG*51EY[2\F1*3PN>:C,GPC*(UWJ4I M.6>:^RO"OVS[N#II,J+$84_*>0PP@K5NNJ)""+OJ49$0OJ[8K,SI#D9/:[@S M3*C4EV1B&8D[#CT9AR;E[[K9:%/[2R&?BQPVNN.AR::VTI'\4Z?O8NN^U6K9 M*90(=`CJS2:S(T[UA\)18EI$?>4\&MIW1HGP\%/FM-OY8T]<^X_IW6JEEQ/B MRHST'Y4*GFFEQ3(\Z3*/]>HO"Z'AS.^3]76OR4K'?/Q3Z]GJ6:#@'!E`5I*1 M1XL9_.S$K#;N(946GUF.5:3&:B.0&G67'FD1UK7;HCO*M^M,CM(1:F:,,6OCMX M?--N:8F(G73CYC6-=^U7I].9@%*4E:EJE/N27G%V6WEV%9DLR)2DDEWB')ER MSDT_AB(_;R[UHC1*JW:#@6D&95.OT^*LL[3DEK2?0)5[]`Z<'TKJLWR8[V_L MSIZ59O6-\H_]8,,2/]FAU:NGP'3Z=)6CE74--?XAV?T#/7\RV/%_->OLB9GU M(\6.&LO&^':--_VO!"XR%>2_5Y\>-9WS:C]+6)_0='3\SJ->ZE+6]=N6#FM. MZ#J_MEGY)%7HU$0?!"B/SG2_;D.,H_\`&'B_3L>ZF7)_-:*1Z*Q,^LTO/&(/ MZ:U29EK6,ZY-,_*:BNM4YH_V8C;:_P#&']8QT_*P8J^6)O/^*9CU'ASQF6:- MV.=FS+I//41JH2"SOU%;L]9^$Y2W12__`&#K9C2,DTCLII3_`"Q!X5>QU,"D MTNG-:*GPV(;7JX[:&D_V((B'EY<^3).M[3:>^=5XB(;0R2`````````````` M``````````````````````````````````@8RP1A_%U,Z#5F+RVSOPYC9W)$ M9WYKK+A94J(_D/A&E^N^/(OU=(K,7K^7;=W3QK/V=SZXA:5I):#)2%$1I41VD9'F,C'FS&C!Y M$``````````G53[]1_?%_A)`!AOX=I?N;'V20%$``1<9UBI47#%2JM.C-2I4 M*.[()M]9MMV-(-9FHTDI1V$G,6?NEG`G2FH\5VF1Y9TIEA272? M.4<(I27E.$HT:*\=PTDBVSC7N`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`B(CIN@C?GOYL7ONI8L[4E&9&6'V2X#)%6=_1H&A.GTR..>?-2/MD^/N>O7_: MFLRO56@M%PFBF559_P")Q(<_TR/NYY_M4_VFE^YY5.[17#M/%M.8MX&Z%,59 M]-\(ZGZ='_HY)_\`:\UTY+5^&/+VQ'#3U.:O3VBS[<6!.S%\R55W*G77.% M54?J4E)^%L[&O\`^*_\`Z#J:_E\F+^2E:^O37UNGPHX[704B+V;4MM7RJ2T1F.#/\`4>HS?F9+V\MIE:*1&Z%C>FB^M=U=_FQQK/.]-%]: M[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V M`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]: M[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V M`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]: M[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V M`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]: M[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V M`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]: M[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8!O31?6NZN_P`V M`;TT7UKNKO\`-@&]-%]:[J[_`#8#C>T1JFU:.S6*26DQ!2DKT##T9\V9L9PO M]1`D$;9DIM])9+?)588C6U9B])TO7=+JZ;+6-:7^2V_N[_,YZ@8E50*>Q5L' M=*J^%'?OF$7&WE3:5'6K^X99A]!3J\'U"(C-,8\_#)]VW M=DCA/\<>=RYL%L-IKOC]ML/HE&[1,(UF&4NG35/M$=QTDLO&MIRRTVW4DBU" MT\*591Y76='EZ>_)DC2WMCMB>,=ZM;1,:PW]Z:+ZUW5W^;'*L;TT7UKNKO\` M-@&]-%]:[J[_`#8!O31?6NZN_P`V`;TT7UKNKO\`-@&]-%]:[J[_`#8`6*** M9D1.NVG_`/7?]`!DJGWZC^^+_"2`##?P[2_49J M(LA&`VZ-1*91H70Z:SH6+ZG%6J6XM2UG:I:W'#6M:C[JC,P&&9\24SW>7^\P M`J``````#E,;]E^#<:Z%5?B*?>C(4W'>;=6VMLE':=ETR+/W2,6YYY)I]VW# MR<>Z>]I@RVQ9/$I.EM-/-WPL8;PU1L-TEJDT:/T6`R:C;9O*78:CM5E6:CRF M*LYF9F9F=9F=9U4P```````````````````````````````````````````` M`````````````````````````````````!\^KZ5X&Q*O%4@BXKQ?\`2\F;%.7#DK:DQK36)B9CO[)X<64]1$3I,/L%4JB85&DU-II4 MM+#"GVVF\[A$F\1$=AY^[8/D,&'GR129Y=9T\CHF=(U?F.DB0=]*=`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``G53[]1_?%_ MA)`!AOX=I?N;'V20%$```````$J9\24SW>7^\P`J@``````````````````` M```````````````````````````````````````````````````````````` M``````````#\^=KO8GCW$7:5"KM'GWXLI3:.EJ432Z:3'&(RNW5+3;:I%WC7 MLA]T-CR1&3FW0YN)@S$*)%)4JXTDC;747"<;4 MHB8FKEH2KZ@C4LR<,E*:4A)J,[2NV$*16=CHMGII;U>C3M]NJLS1J[O>552W MT:.^E"IA])TB%(0T;>AT&C*Q1+L43A*S>$R%M)UU9SDKX?+O\WKU=6+N4``$ MZJ??J/[XO\)(`,-_#M+]S8^R2`H@```````E3/B2F>[R_P!Y@!5````````` M```````````````````````````````````````````````````````````` M``````````````````````````````!.JGWZC^^+_"2`##?P[2_8`50``````` M```````````````````````````````````````````````````````````` M````````````````````````````````3JI]^H_OB_PD@`PW\.TOW-C[)("B M```#EZUCI-&JKD.=29:8J(\B9UDE<53.@B,Z5U9HTVF21&9-VJ;+C&7!E`9H M.-X$G"S^(W8[C,1B_P#5)=C25K-!DDDH5%=?:-2EG=)-^VW/8`WZ!745B,^Y MT5Z%)BO*C2X\E,/N1Y=OTF`%0`` M```````````````````````````````````````````````````````````` M`````````````````````````````````````$ZJ??J/[XO\)(`,-_#M+]S8 M^R2`H@```CR\.-R9U1FG(4A^=#;@MJ)#:M"AM3BS4@G$K2J^IVU1*29'=(!- M1@5:Z348,RHF\Y5KSDZ0VRVU]>26D,.M(*\A&B2P60[;QY3[@"IARANTF-)Z M3+.?.G2%2ILLVTM$MPT);*ZVC(E*6VDI(K3S9P'I/PG19U79J4B(RXZVAQ#A M+;2HUFY-@S#S+LI:X,=Q,AT MG&T&TFQM)-H1<+/DM0:OE`;&ZN&MF1N23X@#=7#6S(W))\0!NKAK9D;DD^(` MW5PULR-R2?$`;JX:V9&Y)/B`-U<-;,C5"CN M(D+2IMLVDV-DE"4&19\YIO`-G=7#6S(W))\0!NKAK9D;DD^(`W5PULR-R2?$ M`;JX:V9&Y)/B`-U<-;,CV&_AVE^YL?9)`40`` M```````````!-Q$_(CT>0\Q.9IJT$1JG2$:1#2+Q7E7+R+RK/)(SSV9\P#A% MXQQK%;7+EK:)-**&4FGG&-M^:B?*<8;<,C6:HZ]$E*]&1'QKQ'W"#R6),D6F6AY1Q&FW'VT*)!LDJ^:K;AGPV&`^@46>51H\&H M$I"BF1VGR4W>N'I$$NU-XB59ER6E:`W````````````<5B_$&(J35%OT^2Q+ M8C,.2'Z,3)FM,=ME:UR'I!+XG'226TW>-FRY32$1_%6-&I,FCE58BI4.*[5# MJAQ2)MQMMAMTHIMZ2Q/&<,S62K;EG#Q@%3"O:.6(,7JIC9I9BE`-Y,5;+R'] M.VXA+BE+6E*+G'L019[+W"1`.\```````````!KU%4A$"2N,ZTP^EM9M/OD9 MM(423L6X1&@S2G.?&+P@/G#F*\:MQW[M084Q"BS*K&J+T31G/C1"9(D:+2%H MTJ6ZLB<3E--Q1%ERAX7C#'$AHE07&G7ZR4A5/AI::;=AE$J#45234^\A#JE- M.J.Q5G'+)DR`.YPI4'I]"COR''')25.L2E.H;;7IF'5-.I-+2EM\5:#*U"C( M\Y`*X```````````.1Q56,04^KQSILIE]"4$ZY128-;JV$F?2'W7[_U24)+Z MOB\9?%RVY`YYC%6,WI42D=:1$R:C%:JB*F44C0RVXPZ\<71Z2Q65DC)9G;.QTCRI3D\XPRQ,88DG&4ERHM4Z#4F MZBII!1B6Y`*EN))2UFI?UND1>O$:2LM39WPZ_!;E=>PW#DUQ\GY\E)OF9-)9 M-+;AWFD+0DS*^ELR)=GSK0%L```````````',XTGU^(F*=&F,M2EFHH]/6P< MAV6\5EUORT:-HBM-QSYI9;2(LH-,6KD1&DRX[98@>?9A_Z>TZ?T>>B)QK M7/KC6E?SB+C][B@$/'F*G:Q3XZE-.1([[<*JR&V2)A2W)K\,G'%&[I&C=)E" MF4MI65Y5BS(K#`?3P`````!.JGWZC^^+_"2`##?P[2_D M1&WJ:2B@.)91>9):C4K1JLM3:I1G\I@/3<7!?0G(/4<'H;KW27(_1V[AO%D) M=VRRVS)X,@"VA"&T)0A)(0@B2E*2L(B+(1$1`/(```````````(\C!^%I%9Z MZ?I45RK<7_7*:2;QW$W4VKLM.ZG(0#'N)@OH"*?U'!Z"V]TE$;H[>C)XRLTE MVRR]=R>#)F`6.C1^DE)T:>D)0;1.V%>)!F2C3;W+2M`9````````````8)\" M%4(3\&BG+;2;R=$9J;L7GXBC,R[@#%N+@LX+D#J.#T)UXI+D;H[>C4\16$ MLTV67K#L\&3,`W6:!0V:FJJLP([=26V3*YB&D)=-M)$1)-9%;81$1>`B`;X` M``````````,4B,TE;X`'JY@["CASS71X:CJMG6)FPW:_8=XM)DXW& MXWARYP&1&%,,MR(4A%*B)?IJ":I[B64$IALLR6S(N*1<%@"H``````)U4^_4 M?WQ?X20`8;^':7[FQ]DD!1`````````````````````````````````````` M```````````````````?+U]K%8IDZIQZ_3VXT?#-X\03&B4:'BENDW2DP24O MRI"5WG+YV-F1D9Y;2#>F]M^$XE$@5AR/,5'FK>0MM*&C=9*,ZEEU:TZ0KZ$K M67&:OD990'34'%<>MU.L0HT.2VW192H,B8Z3:67'TH0M26K%J<58EQ)VFDB` M7````````````````````````````````````````````````3JI]^H_OB_P MD@`PW\.TOW-C[)("B``````````````````````````````````````````` M``````````````CS<(8;G*J:I<%#IUE+**D:E+^M*-;H#R*XBF[;4J389'ES M@)T[LPP-.B,1)=,TK,=MYI%K\@EJ1)<)YXG7"<);M]U).'I#5QBO9\H"[3J/ M3::J8N$P3*I\A4R89&H[[ZTI0I9WC.RU+:2R9`&X```````````````````` M```````````````````````````"=5/OU']\7^$D`&&_AVE^YL?9)`40```` M```````````````````````````````2BKKKC\AN-3)4E$9TV5O(.,E)K21& M=W2/(5DM\T![=;5#8LSZB$Z3FDZUCK:-5 MV[9HKKA6V6\;Y!G:^CS.J^HVIIRUF/YH5,-=I25FD*S(96"5U/#E8K\[&E.3*??3&BP9M.E MQSO):=FPUQ]-(,K")5IKL0KN7K`&]5^U)--JCC+&:OB;/BFT>'Y( MG3U\>QC'43S::>]],HW:@FJ52-3]T\20>DKN=+F4XV8[>2V\XY?.Z7?L'S74 M?1?"I-_&P6TX5OK,^2-&T9-9W2YZ!B5^%7*FYTV=592&Z@Z]&8>>-UE+1*6V MA^G/MFW'NW=&TMI7UAV&9*O#Q6B12:]7ZAAHJ.Q+EU.H,U>,V[-9G/QX\IE] MMP[(M03??T5K5Y9V<59J;(B)(#NCA8DIG9Y4V9U0.//4A\X\DWI$Q41EP[$$ MJ22"?=-I)F>DNVE\EH#B6Z].)IA":G*0XR5F''6)4M^/5)?24WS2I]3CC[=Q M24:-Q2DIXZDY.,0=1V>U.7*KK[:I\F8\<5:Z[&?6M;<2>4DTH:;2HK&>)?*X MG)=2E5F6TPYX\6=HM.HM$J;L=N6TB-.>9;:>D./R5-LJ-OI;:FVTD2?+.Q9Y MLG=`>)';!B>-3*>\ZW"5(>>5E903S,MA#K;9FTXB2:4++2*O);TUEV\=A`,L M2M8S=GL0VJO8XZNFG&;?:<6:4./S&WG';KB#=2>C3:7%^:5O=#I)]?J"QA M^<[5(3KRELO5%M;YOLDZVA:(\I;K*W4HOJXY)=5DR\4K3#S+[2L>195*;Z'! M<14E..MFM*HZ5I3)..F*VMQZTWB0G2&I*5'QBL181F`V>TBJ*CXQC1Y%5:I\ M$X"7$HDU:924*<-]9*4@XA'I5$DBM)6;)W0'BO=IE>IU7F16#AJ2PVT5/B-M]7])4TX9I<=7T13ZGV4FYI#;0 MZFY=T9\-JR.P!6IV(\8.XOH\&IS8K<8W'D2$QXSC2)!O06Y++9&XZY=4TJ_8 M>6\19B`6<1=HA42J.4\\-5ZI:-*5=+IT$Y$=5XK;$N7TVF68\@SMDTG=+LP] M)SUUYZ5\LZ2X*K_^QDJ%C6FT5&$JHB))1]?'DQU-5%:EG8@X\>\9*25T[;3R M]ZS+E/4;=-)=V/Z1$XYMSUUCO^'SR["+VL)D266-S\3M:9:6]*[3#2VB\9%> M6K29$E;:9C2,O=+DMT&D:^)C_O)[=;<8[076ESY4V0N6XVFFM/O-NM,)949$ MNG.-FPMBU-J9*%I49F67.0U<#FZ1BJN3:-78"9BN\5U%MU99,Y6@-C>)G^1GZJ[X@#>)G^1GZJ[X@#>)G^ M1GZJ[X@#>)G^1GZJ[X@&LY4:4[-9GNTB4N;&2M$>2J$LW&TN67TH6:;R2585 MM@C1:+S$::[);.\3/\C/U5WQ"53>)G^1GZJ[X@#>)G^1GZJ[X@#>)G^1GZJ[ MX@#>)G^1GZJ[X@#>)G^1GZJ[X@'MAEEYFAQ4/-J9 EX-21 5 stjude090797_ex21.htm SUBSIDIARIES OF THE REGISTRANT

Exhibit 21

ST. JUDE MEDICAL, INC.
SUBSIDIARIES OF THE REGISTRANT
as of January 3, 2009

 

 

 

 

 

St. Jude Medical, Inc. Wholly Owned Subsidiaries:

MediGuide, Inc. (Delaware corporation)

 

-

MediGuide Ltd. (Israeli corporation)

Pacesetter, Inc. - Sylmar, California, Scottsdale, Arizona, and Maven, South Carolina

 

(Delaware corporation) (dba St. Jude Medical Cardiac Rhythm Management Division)

St. Jude Medical S.C., Inc. – Austin, Texas (Minnesota corporation)

 

-

San Diego Pace, Inc. (California corporation)

St. Jude Medical Europe, Inc. - St. Paul, Minnesota (Delaware corporation)

 

-

Brussels, Belgium branch

St. Jude Medical Canada, Inc. - Mississauga, Ontario and St. Hyacinthe, Quebec

 

(Ontario, Canada corporation)

St. Jude Medical (Shanghai) Co., Ltd. – Shanghai, China (Chinese corporation)

 

-

Beijing, Shanghai and Guangzhou representative offices

St. Jude Medical Australia Pty., Ltd. – Sydney, Australia (Australian corporation)

St. Jude Medical Brasil, Ltda. - Sao Paulo and Belo Horizonte, Brazil (Brazilian corporation)

St. Jude Medical, Atrial Fibrillation Division, Inc. (Formerly St. Jude Medical, Daig Division, Inc.) - Minnesota and California (Minnesota corporation)

 

-

Endocardial Solutions NV/SA (Belgian Corporation)

 

-

EP MedSystems LLC (Minnesota Limited Liability Company)

 

 

-

ProCath Corporation (New Jersey corporation)

 

 

-

EP MedSystems U.K. Ltd., (New Jersey corporation) (dba EP MedSystems, Europe Ltd.)

 

 

 

-

EP MedSystems France. (French corporation) (wholly owned subsidiary of EP MedSystems U.K. Ltd.)

St. Jude Medical Colombia, Ltda. - Bogota, Colombia (Colombian corporation)

St. Jude Medical ATG, Inc. - Maple Grove, Minnesota (Minnesota corporation) (Shell)

St. Jude Medical (Thailand) Co., Ltd. – Bangkok, Thailand (Thai corporation)

Irvine Biomedical, Inc. – Irvine, California (California corporation)

St. Jude Medical, Cardiology Division, Inc. (Formerly Velocimed, Inc.) - Minnesota (Delaware corporation) (dba St. Jude Medical Cardiovascular Division)

SJ Medical Mexico, S. de R.L. de C.V. (Mexican corporation)

St. Jude Medical Argentina S.A. – Buenos Aires, Argentina (Argentinean corporation)

Advanced Neuromodulation Systems, Inc. – Plano, Texas (Texas Corporation) (dba St. Jude Medical Neuromodulation Division)

 

-

Hi-Tronics Designs, Inc. – Budd Lake, New Jersey (New Jersey Corporation)

 

-

Advanced Neuromodulation Systems, UK Limited (United Kingdom corporation)

SJM International, Inc. - St. Paul, Minnesota (Delaware corporation)

 

-

Tokyo, Japan branch


 

 

 

 

 

 

SJM International, Inc. Wholly Owned Legal Entities (Directly and Indirectly):

SJM Delaware Holding, LLC - St. Paul, Minnesota (Delaware Limited Liability Company)

St. Jude Medical Bermuda GP (Bermuda partnership) (SJM International, Inc. is the majority partner and SJM Delaware Holding LLC is the minority partner)

 

-

St. Jude Medical Luxembourg Holding S.à r.l. (Luxembourg corporation)

 

 

-

St. Jude Medical Nederland B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

-

St. Jude Medical Puerto Rico LLC (Puerto Rican corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

-

St. Jude Medical AB (Swedish corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

 

-

Radi Medical Systems AB (Swedish corporation)

 

 

 

 

-

Radi Medical Systems, Inc. (US corporation)

 

 

 

 

-

Radi Medical Systems GmbH (German corporation)

 

 

 

 

-

Radi Medical Systems Ltd. (United Kingdom corporation)

 

 

 

 

-

Radi Medical Systems B.V. (Dutch corporation)



 

 

 

 

 

 

 

 

 

 

-

Radi Medical Systems Pty. Ltd. (Australian corporation)

 

 

 

 

-

Radi Medical Systems KK (Japanese corporation)

 

 

 

 

-

Radi Medical Systems Co., Ltd. (Thai corporation)

 

 

 

 

-

Radi Medical Systems s.a.s. (French corporation)

 

 

 

 

-

Radi Medical Systems Pte., Ltd. (Singaporean corporation)

 

 

 

 

-

Beijing, China representative office

 

 

 

-

HB Betakonsult (Swedish partnership) (St. Jude Medical AB holds a 99% interest and Radi Medical Systems AB holds a 1% interest)

 

 

-

SJM Coordination Center BVBA (Belgian corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg S.à r.l.)

 

 

 

-

Cardio Life Research S.A. (Belgian corporation)

 

 

-

St. Jude Medical Operations (Malaysia) Sdn. Bhd. (Malaysian corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

-

St. Jude Medical Costa Rica Limitada (Costa Rica corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

-

St. Jude Medical Holdings B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)

 

 

 

-

St. Jude Medical Japan Co., Ltd. (Japanese corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)

 

 

 

-

St. Jude Medical India Private Limited (Indian corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)

 

 

 

-

St. Jude Medical (Singapore) Pte. Ltd. (Singaporean corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)

 

 

 

-

St. Jude Medical (Malaysia) Sdn Bhd (Malaysian corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)

 

 

 

-

St. Jude Medical Taiwan Co. (Taiwan corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)

 

 

 

-

St. Jude Medical Korea YH (Korean corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.

 

 

 

-

St. Jude Medical (Hong Kong) Limited - Central, Hong Kong (Hong Kong corporation)

 

 

 

 

-

Mumbai, New Delhi, Calcutta, Chennai and Bangalore, India branch offices

St. Jude Medical Sweden AB (Swedish corporation)

St. Jude Medical Danmark A/S (Danish corporation)

St. Jude Medical (Portugal) - Distribuição de Produtos Médicos, Lda. (Portuguese corporation)

St. Jude Medical Export Ges.m.b.H. (Austrian corporation)

St. Jude Medical Medizintechnik Ges.m.b.H. (Austrian corporation)

St. Jude Medical Italia S.p.A. (Italian corporation)

St. Jude Medical Belgium (Belgian corporation)

St. Jude Medical España S.A. (Spanish corporation)

St. Jude Medical France S.A.S. (French corporation)

St. Jude Medical Finland O/y (Finnish corporation)

St. Jude Medical Sp.zo.o. (Polish corporation)

St. Jude Medical GmbH (German corporation)

St. Jude Medical Kft (Hungarian corporation)

St. Jude Medical UK Limited (United Kingdom corporation)

St. Jude Medical (Schweiz) AG (Swiss corporation)

UAB “St. Jude Medical Baltic” (Lithuanian corporation)

St. Jude Medical Norway AS (Norwegian corporation)



EX-23 6 stjude090797_ex23.htm CONSENT OF INDEPENDENT REG. PUBLIC ACCT. FIRM

Exhibit 23

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in this Annual Report (Form 10-K) of St. Jude Medical, Inc. of our reports dated February 26, 2009, with respect to the consolidated financial statements of St. Jude Medical, Inc., and the effectiveness of internal control over financial reporting of St. Jude Medical, Inc., included in the 2008 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)(2). This schedule is the responsibility of St. Jude Medical, Inc.’s management. Our responsibility is to express an opinion based on our audits. In our opinion, as to which the date is February 26, 2009, 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 the Registration Statements on Form S-8 (Nos. 33-54435, 333-42945, 333-42668, 333-96697, 333-130180, 333-136398, 333-143090, 333-149440 and 333-150839) of St. Jude Medical, Inc. of our reports dated February 26, 2009, with respect to the consolidated financial statements of St. Jude Medical, Inc., and the effectiveness of internal control over financial reporting of St. Jude Medical, Inc., incorporated herein by reference, and our report included in the preceding paragraph with respect to the financial statement schedule of St. Jude Medical, Inc. included in this Annual Report (Form 10-K) of St. Jude Medical, Inc.

/s/ Ernst & Young LLP

Minneapolis, Minnesota
February 26, 2009


EX-24 7 stjude090797_ex24.htm POWER OF ATTORNEY

Exhibit 24

POWER OF ATTORNEY

KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Daniel J. Starks, John C. Heinmiller and Pamela S. Krop, 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 January 3, 2009, 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 20th day of February, 2009, by the following persons.

 

 

 

 

 

 

/s/    BARBARA B. HILL

 

Daniel J. Starks

 

Barbara B. Hill

 

Chairman, President and Chief Executive Officer

 

Director

 

(Principal Executive Officer)

 

 

 

 

 

 

 

/s/    JOHN C. HEINMILLER

 

/s/    MICHAEL A. ROCCA

 

John C. Heinmiller

 

Michael A. Rocca

 

Executive Vice President and

 

Director

 

Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

 

 

 

 

 

 

/s/    JOHN W. BROWN

 

/s/    STEFAN K. WIDENSOHLER

 

John W. Brown

 

Stefan K. Widensohler

 

Director

 

Director

 

 

 

 

 

/s/    RICHARD R. DEVENUTI

 

/s/    WENDY L. YARNO

 

Richard R. Devenuti

 

Wendy L. Yarno

 

Director

 

Director

 

 

 

 

 

/s/    STUART M. ESSIG

 

 

 

Stuart M. Essig

 

 

 

Director

 

 

 

 

 

 

 

/s/    THOMAS H. GARRETT III

 

 

 

Thomas H. Garrett III

 

 

 

Director

 

 

 



EX-31.1 8 stjude090797_ex31-1.htm CERTIFICATION OF CEO PURSUANT TO SECTION 302

Exhibit 31.1

CERTIFICATION PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

 

I, Daniel J. Starks, 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

 

 

 

 

c)

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

 

 

 

 

 

 

d)

Disclosed in this report any change in the registrant’s internal control 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 control over financial reporting; and

 

 

 

 

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control 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 control 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 control over financial reporting.


 

 

Date: February 27, 2009

 

 

 

/s/   DANIEL J. STARKS

 

Daniel J. Starks

 

Chairman, President and Chief Executive Officer

 



EX-31.2 9 stjude090797_ex31-2.htm CERTIFICATION OF CFO PURSUANT TO SECTION 302

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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

 

 

 

 

c)

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

 

 

 

 

 

 

d)

Disclosed in this report any change in the registrant’s internal control 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 control over financial reporting; and

 

 

 

 

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control 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 control 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 control over financial reporting.


 

 

Date: February 27, 2009

 

 

 

/s/   JOHN C. HEINMILLER

 

John C. Heinmiller

 

Executive Vice President and Chief Financial Officer

 



EX-32.1 10 stjude090797_ex32-1.htm CERTIFICATION OF CEO PURSUANT TO SECTION 906

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 January 3, 2009 as filed with the Securities and Exchange Commission (the “Report”), I, Daniel J. Starks, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. §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/   DANIEL J. STARKS

 

 

Daniel J. Starks

 

 

Chairman, President and Chief

 

 

Executive Officer

 

 

February 27, 2009

 



EX-32.1 11 stjude090797_ex32-2.htm CERTIFICATION OF CFO PURSUANT TO SECTION 906

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 January 3, 2009 as filed with the Securities and Exchange Commission (the “Report”), I, John C. Heinmiller, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §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

 

 

Executive Vice President and

 

 

Chief Financial Officer

 

 

February 27, 2009

 



-----END PRIVACY-ENHANCED MESSAGE-----