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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Minnesota
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41-1276891
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(State or other jurisdiction of
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(I.R.S. Employer Identification No.)
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incorporation or organization)
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One St. Jude Medical Drive
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(651) 756-2000
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St. Paul, Minnesota 55117
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(Registrant’s telephone number,
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(Address of principal executive
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including area code)
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offices, including zip code)
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Securities registered pursuant to Section 12(b) of the Act:
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Common Stock ($.10 par value)
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New York Stock Exchange
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(Title of class)
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(Name of exchange on which registered)
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Securities registered pursuant to Section 12(g) of the Act: None
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Large accelerated filer
x
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Accelerated filer
o
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Non-accelerated filer
o
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(Do not check if a smaller reporting company)
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Smaller reporting company
o
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ITEM
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DESCRIPTION
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PAGE
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PART I
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1.
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1A.
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1B.
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2.
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3.
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4.
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PART II
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5.
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6.
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7.
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7A.
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8.
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9.
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9A.
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9B.
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PART III
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10.
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11.
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12.
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13.
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14.
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PART IV
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15.
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Item 1.
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BUSINESS
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Net Sales
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2014
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2013
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2012
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||||||
ICD Systems
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$
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1,746
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$
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1,741
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$
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1,743
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Pacemaker Systems
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1,047
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1,042
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1,111
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Atrial Fibrillation Products
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1,044
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957
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898
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Vascular Products
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709
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704
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716
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Structural Heart Products
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639
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631
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612
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Neuromodulation Products
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437
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426
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423
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Net sales
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$
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5,622
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$
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5,501
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$
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5,503
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▪
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An ICD monitors the heartbeat and delivers high-energy electrical impulses, or “shocks,” to treat potentially lethal, abnormally fast heart rhythms -- ventricular tachycardia (VT) and ventricular fibrillation (VF) -- which often lead to sudden cardiac death (SCD). In VT, the lower chambers of the heart (ventricles) 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.
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▪
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A CRT-D device resynchronizes the beating of the ventricles, which often beat out of sync in heart failure patients, and provides backup treatment for SCD, which is a risk factor associated with certain types of heart failure. Cardiac resynchronization therapy can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.
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▪
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Mechanical Valves: Our Regent™ mechanical heart valve received European CE Mark approval in December 1999 and FDA approval in March 2002. Over the last 35 years more than two million St. Jude Medical mechanical heart valves have been implanted.
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▪
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Tissue Valves: With the acquisition of Biocor Industries, Inc. in 1996, St. Jude Medical strengthened our position in the tissue heart valve market. We currently market both the Epic™ and Biocor™ porcine stented tissue heart valves. In March 2010, we received European CE Mark approval for our Trifecta™ tissue heart valve, marking our expansion into the pericardial aortic stented tissue valve market. FDA approval for the Trifecta™ tissue valve followed in April 2011 and the product was launched in Japan in April 2012. The Trifecta™ tissue valve has a tri-leaflet stented pericardial design which offers hemodynamic performance (the optimization of blood flow through the valve) that mimics as closely as possible the flow of a natural, healthy heart valve. The Trifecta™ valve also features our patented Linx™ AC, an anti-calcification treatment designed to increase the valve's durability by reducing tissue mineralization (hardening) which is one of the primary causes of valve deterioration.
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▪
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Valve Repair: We also offer a complement of heart valve repair products, including two fully flexible and two semi-rigid rings: the Tailor™ flexible ring and the Attune™ flexible adjustable annuloplasty ring, and the SJM™ Séguin Semi-Rigid Ring and the SJM™ Rigid Saddle Ring. Annuloplasty rings are prosthetic devices used to repair diseased or damaged mitral and tricuspid heart valves.
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▪
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Transcatheter Aortic Valve Replacement (TAVR): Building upon our experience in the surgical heart valve market, St. Jude Medical developed the Portico™ transcatheter aortic valve for a minimally invasive alternative to open heart surgery. The Portico™ transcatheter 23 mm aortic valve and the transfemoral delivery system received European CE Mark approval in November 2012, and the 25 mm valve received European CE Mark approval in December 2013. In addition, in 2014 we initiated the U.S. IDE trial to evaluate the safety and efficacy of the Portico™ transcatheter aortic valve and delivery systems for patients with symptomatic severe aortic stenosis who are considered at high or extreme risk for open heart surgery. In September 2014, we paused global implants of the Portico™ valve to ensure patient safety while further investigating reports of reduced leaflet mobility seen in the 4D CT imaging and transesophageal echo imaging. Our evaluation has not suggested the need for device redesign or modification. St. Jude Medical has now begun to resume implants of the Portico™ valve in some geographies, and remains in discussions with global regulatory authorities to complete the global resumption of clinical and commercial implants. Those discussions include communication with the FDA to resume implants within our U.S. IDE.
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▪
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Closure Devices: Through the acquisition of AGA Medical in 2010, we extended our portfolio to the transcatheter treatment of structural heart defects. Transcatheter closure offers pediatric and adult patients a minimally invasive alternative to surgery. The majority of this portfolio includes a line of occluder devices to treat congenital heart defects, including atrial septal defects, the most common congenital heart defect. Our portfolio includes the AMPLATZER™ Septal Occluder for closure of atrial septal defects (FDA approval in 2001 and European CE Mark approval in 1998), the AMPLATZER™ Muscular VSD Occluder for closure of muscular ventricular septal defects (FDA approval in 2007 and European CE Mark approval in 1998) and the AMPLATZER™ Duct Occluder for closure of patent ductus arteriosus (FDA approval in 2003 and European CE Mark approval in 1998). In 2013, we received FDA approval for the AMPLATZER™ Duct Occluder II (European CE Mark approval in 2008) for closure of patent ductus arteriosus, expanding the percutaneous treatment indication for patent ductus arteriosus. In addition to our portfolio of treatment options for congenital heart disease, the AMPLATZER portfolio also includes devices for patent foramen ovale (PFO) closure, sealing a hole in the septum between the right and left sides of the heart, and left atrial appendage (LAA) closure to reduce the risk of ischemic stroke in patients with AF.
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Establishment registration and product listing requirements;
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Quality System Regulation (QSR) requires manufacturers, including third-party manufacturers, to follow stringent design, testing, documentation and other quality assurance procedures during product design and throughout the manufacturing process;
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Labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses and against making false and misleading claims; and
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Medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur.
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Fines, injunctions, consent decrees and civil penalties;
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Recall or seizure of our products;
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Operating restrictions, partial suspension or total shutdown of production;
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Refusing our requests for 510(k) clearance or PMA of new products or new intended uses;
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Refusing to provide documents needed to export products;
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Withdrawing 510(k) clearance or PMAs that are already granted; and
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Criminal prosecution.
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Name
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Age
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Position
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Daniel J. Starks
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60
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Chairman (2004), President (2001) and Chief Executive Officer (2004)
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John C. Heinmiller
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60
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Executive Vice President (2004)
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Michael T. Rousseau
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59
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Chief Operating Officer (2014)
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Lisa M. Andrade
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43
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Vice President, Chief Marketing Officer (2014)
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I. Paul Bae
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50
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Vice President, Global Human Resources (2015) and Chief Compliance Officer (2012)
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Joel D. Becker
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47
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President, Americas Division (2014)
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Mark D. Carlson, M.D.
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59
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Vice President, Global Clinical Affairs and Chief Medical Officer (2013)
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Jeffrey A. Dallager
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40
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Vice President and Corporate Controller (2014)
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Rachel H. Ellingson
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45
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Vice President, Global Communications (2014)
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Eric S. Fain, M.D.
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54
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Group President (2014)
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Jeff A. Fecho
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54
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Vice President, Global Quality (2012)
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Denis M. Gestin
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51
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President, International Division (2008)
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Mark W. Murphy
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46
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Vice President, Information Technology and Chief Information Officer (2013)
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Scott P. Thome
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52
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Vice President, Global Operations and Supply Chain (2014)
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Jason A. Zellers
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49
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Vice President, General Counsel and Corporate Secretary (2011)
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Donald J. Zurbay
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47
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Vice President, Finance (2006) and Chief Financial Officer (2012)
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Item 1A.
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RISK FACTORS
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take a significant amount of time,
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require the expenditure of substantial resources,
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involve rigorous pre-clinical and clinical testing, as well as increased post-market surveillance,
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involve modifications, repairs or replacements of our products, and
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result in limitations on the indicated uses of our products.
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require us to notify health professionals and others that the devices present unreasonable risk of substantial harm to public health;
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order us to recall, repair, replace or refund the cost of any medical device that we manufactured or distributed;
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detain, seize or ban adulterated or misbranded medical devices;
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refuse to provide us with documents necessary to export our products;
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refuse requests for 510(k) clearance or PMA of new products or new intended uses;
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withdraw 510(k) clearances or PMAs that are already granted;
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impose operating restrictions, including requiring a partial or total shutdown of production;
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enjoin or restrain conduct resulting in violations of applicable law pertaining to medical devices; and/or
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assess criminal or civil penalties against us or our officers and employees.
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the presence or absence of adequate internal controls and/or significant fraud in the financial systems of acquired companies;
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adverse developments arising out of investigations by governmental entities of the business practices of acquired companies;
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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;
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our ability to retain key employees; and
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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.
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the imposition of or increase in import or export duties, surtaxes, tariffs or customs duties;
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the imposition of import or export quotas or other trade restrictions;
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foreign tax laws and potential increased costs associated with overlapping tax structures;
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compliance with various U.S. and foreign laws, including the Foreign Corrupt Practices Act, the UK Anti-Bribery Act and import/export laws;
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longer accounts receivable cycles in certain foreign countries, whether due to cultural, economic or other factors;
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changes in medical reimbursement programs and regulatory requirements in international markets in which we operate; and
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economic and political instability in international markets, including concerns over excessive levels of sovereign debt and budget deficits in countries where we market our products that could result in an inability to pay or timely pay outstanding payables.
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Item 1B.
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UNRESOLVED STAFF COMMENTS
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Item 2.
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PROPERTIES
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Item 3.
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LEGAL PROCEEDINGS
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Item 4.
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MINE SAFETY DISCLOSURES
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Item 5.
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MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
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Fiscal Year
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2014
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2013
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||||||||||||
Quarter
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High
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Low
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High
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Low
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First
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$
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68.79
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$
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59.16
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$
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43.23
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$
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35.32
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Second
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$
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70.59
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$
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59.85
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$
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47.45
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$
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39.79
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Third
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$
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71.90
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$
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61.00
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$
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54.36
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$
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45.38
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Fourth
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$
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70.24
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$
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54.80
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$
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63.15
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$
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51.79
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Item 6.
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SELECTED FINANCIAL DATA
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2014
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2013
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2012
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2011
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2010
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Summary of Operations for the Fiscal Year:
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Net sales
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$
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5,622
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$
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5,501
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$
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5,503
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$
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5,612
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$
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5,164
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Gross profit
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3,969
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3,927
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3,965
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4,079
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3,754
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Percent of net sales
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70.6
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%
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71.4
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%
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72.1
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%
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72.7
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%
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72.7
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%
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|||||
Net earnings attributable to St. Jude Medical, Inc.
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$
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1,002
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$
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723
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$
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752
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$
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826
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$
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907
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Percent of net sales
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17.8
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%
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13.1
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%
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13.7
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%
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14.7
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%
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17.6
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%
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Diluted net earnings per share attributable to St. Jude Medical, Inc.
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$
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3.46
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(a)
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$
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2.49
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(b)
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$
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2.39
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(c)
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$
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2.52
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$
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2.75
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Cash dividends declared per share
(d)
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$
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1.08
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$
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1.00
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$
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0.92
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$
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0.84
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$
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—
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Financial Position at Year End:
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Cash and cash equivalents
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$
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1,442
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$
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1,373
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$
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1,194
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$
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986
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$
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500
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Total assets
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10,207
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10,248
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9,271
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9,118
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8,566
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|||||
Total debt
(e)
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$
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3,866
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$
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3,580
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$
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3,080
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$
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2,796
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$
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2,512
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(a)
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2014 diluted net earnings per share attributable to St. Jude Medical, Inc. included after-tax charges of $150 million, or $0.52 per diluted net earnings per share attributable to St. Jude Medical, Inc., related to restructuring activities associated with our 2012 Business Realignment Plan and Manufacturing and Supply Chain Optimization Plan, acquisition-related charges, intangible asset impairment charges, product field action and litigation charges, and legal settlement expenses, partially offset by a favorable legal settlement and an income tax benefit for discrete income tax adjustments. See the Notes to the
Consolidated Financial Statements
in Item 8. "Financial Statements and Supplementary Data" for further detail.
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(b)
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2013 diluted net earnings per share attributable to St. Jude Medical, Inc. included after-tax charges of $371 million, or $1.27 per diluted net earnings per share attributable to St. Jude Medical, Inc., related to restructuring activities associated with our 2012 Business Realignment Plan and 2011 Restructuring Plan, debt retirement costs primarily associated with make-whole redemption payments and the write-off of unamortized debt issuance costs, acquisition-related charges, intangible asset impairment charges, product field action and litigation charges, and a legal settlement charge, partially offset by an income tax benefit from the enactment of a tax law and the settlement of domestic tax audits. See the Notes to the
Consolidated Financial Statements
in Item 8. "Financial Statements and Supplementary Data" for further detail.
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(c)
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2012 diluted net earnings per share attributable to St. Jude Medical, Inc. included after-tax charges of $321 million, or $1.02 per diluted net earnings per share attributable to St. Jude Medical, Inc., related to restructuring activities associated with our 2012 Business Realignment Plan and 2011 Restructuring Plan, product field action and litigation charges, a legal settlement charge, intangible asset impairment charges, inventory write-offs and an additional income tax charge related to a settlement reserve for certain prior year tax positions. See the Notes to the
Consolidated Financial Statements
in Item 8. "Financial Statements and Supplementary Data" for further detail.
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(d)
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Beginning in fiscal year 2011, the Company began declaring and paying cash dividends. The Company did not declare or pay any cash dividends during 2010.
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(e)
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Total debt consists of current debt obligations and long-term debt.
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Item 7.
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
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timing and amount of revenue and future cash flows, which often depend on estimates of relevant market sizes, expected market growth rates, trends in technology (including the impacts of anticipated product introductions by competitors, legal agreements and patent litigation), the expected useful lives of acquired technologies and the expected introduction date of IPR&D projects;
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•
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expected costs to develop the IPR&D projects into commercially viable products, which include the stage of completion, the complexity of the work to complete and the contribution of core technologies and other acquired assets;
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•
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the discount rate reflecting the risk inherent in future cash flows; and
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•
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perpetual growth rate used to calculate the terminal value, where applicable.
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% Change
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% Change
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||||||||
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2014
|
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2013
|
|
2012
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||
ICD Systems
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$
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1,746
|
|
|
$
|
1,741
|
|
|
$
|
1,743
|
|
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0.3
|
%
|
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(0.1
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)%
|
Pacemaker Systems
|
1,047
|
|
|
1,042
|
|
|
1,111
|
|
|
0.5
|
|
|
(6.2
|
)
|
|||
Atrial Fibrillation Products
|
1,044
|
|
|
957
|
|
|
898
|
|
|
9.1
|
|
|
6.6
|
|
|||
Vascular Products
|
709
|
|
|
704
|
|
|
716
|
|
|
0.7
|
|
|
(1.7
|
)
|
|||
Structural Heart Products
|
639
|
|
|
631
|
|
|
612
|
|
|
1.3
|
|
|
3.1
|
|
|||
Neuromodulation Products
|
437
|
|
|
426
|
|
|
423
|
|
|
2.6
|
|
|
0.7
|
|
|||
Net sales
|
$
|
5,622
|
|
|
$
|
5,501
|
|
|
$
|
5,503
|
|
|
2.2
|
%
|
|
—
|
%
|
|
|
|
|
|
|
|
% Change
|
|
% Change
|
||||||||
|
2014
|
|
2013
|
|
2012
|
|
2014 vs. 2013
|
|
2013 vs. 2012
|
||||||||
United States
|
$
|
2,657
|
|
|
$
|
2,596
|
|
|
$
|
2,594
|
|
|
2.3
|
%
|
|
0.1
|
%
|
Japan
|
526
|
|
|
567
|
|
|
665
|
|
|
(7.2
|
)
|
|
(14.7
|
)
|
|||
Other foreign countries
|
2,439
|
|
|
2,338
|
|
|
2,244
|
|
|
4.3
|
|
|
4.2
|
|
|||
Net sales
|
$
|
5,622
|
|
|
$
|
5,501
|
|
|
$
|
5,503
|
|
|
2.2
|
%
|
|
—
|
%
|
|
2014
|
|
2013
|
||
Constant currency
|
3.5
|
%
|
|
1.8
|
%
|
Translation
|
(1.3
|
)
|
|
(1.8
|
)
|
Net sales change
|
2.2
|
%
|
|
—
|
%
|
Gross profit
|
|
|
|
|
|
|
|
|
2014 vs. 2013 Change
|
|
2013 vs. 2012 Change
|
|
||||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
|
|
|
||||||||||
Gross profit
|
$
|
3,969
|
|
|
$
|
3,927
|
|
|
$
|
3,965
|
|
|
1.1
|
%
|
|
(1.0
|
)%
|
|
Percentage of net sales
|
70.6
|
%
|
|
71.4
|
%
|
|
72.1
|
%
|
|
(0.8
|
)
|
pts.
|
(0.7
|
)
|
pts.
|
Selling, general and administrative (SG&A) expense
|
|
|
|
|
|
|
|
|
2014 vs. 2013 Change
|
|
2013 vs. 2012 Change
|
|
||||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
|
|
|
||||||||||
Selling, general and administrative expense
|
$
|
1,856
|
|
|
$
|
1,805
|
|
|
$
|
1,803
|
|
|
2.8
|
%
|
|
0.1
|
%
|
|
Percentage of net sales
|
33.0
|
%
|
|
32.8
|
%
|
|
32.8
|
%
|
|
0.2
|
|
pts.
|
—
|
|
pts.
|
Research and development (R&D) expense
|
|
|
|
|
|
|
|
|
2014 vs. 2013 Change
|
|
2013 vs. 2012 Change
|
|
||||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
|
|
|
||||||||||
Research and development expense
|
$
|
692
|
|
|
$
|
691
|
|
|
$
|
676
|
|
|
0.1
|
%
|
|
2.2
|
%
|
|
Percentage of net sales
|
12.3
|
%
|
|
12.6
|
%
|
|
12.3
|
%
|
|
(0.3
|
)
|
pts.
|
0.3
|
|
pts.
|
Amortization of intangible assets
|
|
|
|
|
|
|
2014 vs. 2013 Change
|
|
2013 vs. 2012 Change
|
||||||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
|
|||||||||||
Amortization of intangible assets
|
$
|
89
|
|
|
$
|
79
|
|
|
$
|
88
|
|
|
12.7
|
%
|
|
(10.2
|
)%
|
Special charges
|
|
|
|
|
|
|
|
||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
||||||
Cost of sales special charges
|
$
|
56
|
|
|
$
|
45
|
|
|
$
|
93
|
|
Special charges
|
181
|
|
|
301
|
|
|
298
|
|
|||
Total special charges
|
$
|
237
|
|
|
$
|
346
|
|
|
$
|
391
|
|
Other expense, net
|
|
|
|
|
|
||||||
(in millions)
|
2014
|
|
2013
|
|
2012
|
||||||
Interest income
|
$
|
(5
|
)
|
|
$
|
(5
|
)
|
|
$
|
(5
|
)
|
Interest expense
|
85
|
|
|
81
|
|
|
73
|
|
|||
Other (income) expense
|
3
|
|
|
191
|
|
|
27
|
|
|||
Other expense, net
|
$
|
83
|
|
|
$
|
267
|
|
|
$
|
95
|
|
(as a percent of earnings before income taxes and noncontrolling interest)
|
2014
|
|
2013
|
|
2012
|
|||
Effective tax rate
|
10.6
|
%
|
|
11.7
|
%
|
|
25.2
|
%
|
(in millions)
|
2014
|
|
2013
|
|
2012
|
||||||
Net loss attributable to noncontrolling interest
|
$
|
(47
|
)
|
|
$
|
(31
|
)
|
|
$
|
—
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Net cash provided by (used in):
|
|
|
|
|
|
||||||
Operating activities
|
$
|
1,304
|
|
|
$
|
961
|
|
|
$
|
1,335
|
|
Investing activities
|
(339
|
)
|
|
(522
|
)
|
|
(313
|
)
|
|||
Financing activities
|
(827
|
)
|
|
(257
|
)
|
|
(813
|
)
|
|||
Effect of currency exchange rate changes on cash and cash equivalents
|
(69
|
)
|
|
(3
|
)
|
|
(1
|
)
|
|||
Net increase in cash and cash equivalents
|
$
|
69
|
|
|
$
|
179
|
|
|
$
|
208
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Stock issued under employee stock plans, including tax benefit
|
$
|
156
|
|
|
$
|
458
|
|
|
$
|
120
|
|
Common stock repurchases
|
(476
|
)
|
|
(833
|
)
|
|
(992
|
)
|
|||
Dividends paid
|
(303
|
)
|
|
(282
|
)
|
|
(284
|
)
|
|||
Debt borrowings, net
|
275
|
|
|
554
|
|
|
321
|
|
|||
Purchase of shares from noncontrolling ownership interest
|
(344
|
)
|
|
—
|
|
|
—
|
|
|||
Payment of contingent consideration
|
(128
|
)
|
|
—
|
|
|
—
|
|
|||
Other, net
|
(7
|
)
|
|
(154
|
)
|
|
22
|
|
|||
Net cash used in financing activities
|
$
|
(827
|
)
|
|
$
|
(257
|
)
|
|
$
|
(813
|
)
|
|
Payments Due by Period
|
||||||||||||||
|
|
Less than
|
1-3
|
3-5
|
More than
|
||||||||||
|
Total
|
1 Year
|
Years
|
Years
|
5 Years
|
||||||||||
Contractual obligations related to
|
|
|
|
|
|
||||||||||
off-balance sheet arrangements:
|
|
|
|
|
|
||||||||||
Operating lease obligations
|
$
|
122
|
|
$
|
35
|
|
$
|
51
|
|
$
|
29
|
|
$
|
7
|
|
Purchase obligations (a)
|
285
|
|
268
|
|
16
|
|
1
|
|
—
|
|
|||||
Total
|
$
|
407
|
|
$
|
303
|
|
$
|
67
|
|
$
|
30
|
|
$
|
7
|
|
|
|
|
|
|
|
||||||||||
Contractual obligations reflected
|
|
|
|
|
|
||||||||||
in the balance sheet:
|
|
|
|
|
|
||||||||||
Debt obligations (b)
|
$
|
5,091
|
|
$
|
1,670
|
|
$
|
703
|
|
$
|
129
|
|
$
|
2,589
|
|
Contingent consideration and other (c)
|
78
|
|
10
|
|
53
|
|
15
|
|
—
|
|
|||||
Total
|
$
|
5,169
|
|
$
|
1,680
|
|
$
|
756
|
|
$
|
144
|
|
$
|
2,589
|
|
|
|
|
|
|
|
||||||||||
Grand Total (d)
|
$
|
5,576
|
|
$
|
1,973
|
|
$
|
770
|
|
$
|
159
|
|
$
|
2,596
|
|
|
(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)
|
|
Includes current debt obligations, scheduled maturities of long-term debt and scheduled interest payments. See Note 4 to the
Consolidated Financial Statements
within Item 8. "Financial Statements and Supplementary Data" for additional information on our debt obligations.
|
|
(c)
|
|
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. Contingent consideration arrangements with variable interest entities have been excluded from the table, as we have the exclusive right, but not the obligation, to acquire these companies. See Note 2 to the
Consolidated Financial Statements
within Item 8. "Financial Statements and Supplementary Data" for further detail.
|
|
(d)
|
|
The table does not include our liability for uncertain tax positions of $328 million or our related accrual for gross interest and penalties of $44 million as of January 3, 2015, as we are uncertain as to if or when such amounts may be paid. Additionally, the table does not include other liabilities of $301 million pertaining to non-qualified deferred compensation because the timing of the future cash payments is uncertain.
|
1.
|
|
Competition, including product introductions by competitors that have advanced technology, better features or lower pricing.
|
2.
|
|
Safety, performance or efficacy concerns about our products, many of which are expected to be implanted for many years, some of which may lead to recalls and/or advisories with the attendant expenses and declining sales.
|
3.
|
|
A reduction in the number of procedures using our devices caused by cost-containment pressures, publication of adverse study results, initiation of investigations of our customers related to our devices or the development of or preferences for alternative technologies or therapies.
|
4.
|
|
Declining industry-wide sales caused by product quality issues or recalls or advisories by us or 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.
|
5.
|
|
Governmental legislation, including the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act, and/or regulation that significantly impacts the healthcare system in the United States or in international markets and that results in lower reimbursement for procedures using our products or denies coverage for such procedures, reduces medical procedure volumes or otherwise adversely affects our business and results of operations, including the imposition of any medical device excise tax.
|
6.
|
|
Any changes 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.
|
7.
|
|
Changes in laws, regulations or administrative practices affecting government regulation of our products, such as FDA regulations, including those that decrease the probability or increase the time and/or expense of obtaining approval for products or impose additional burdens on the manufacture and sale of medical devices.
|
8.
|
|
Consolidation and other healthcare industry changes leading to demands for price concessions and/or limitations on, or the elimination of, our ability to sell in significant market segments.
|
9.
|
|
Failure to successfully complete, or unfavorable data from, clinical trials for our products or new indications for our products and/or failure to successfully develop markets for such new indications.
|
10.
|
|
Conditions imposed in resolving, or any inability to timely resolve, any regulatory issues raised by the FDA, including Form 483 observations or warning letters, as well as risks generally associated with our health, safety and environmental regulatory compliance and quality systems.
|
11.
|
|
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.
|
12.
|
|
Adverse developments in litigation, including product liability litigation, patent or other intellectual property litigation, qui tam litigation or shareholder litigation.
|
13.
|
|
Our ability to fund future product liability losses related to claims made subsequent to becoming self-insured.
|
14.
|
|
Economic factors, including inflation, contraction in capital markets, changes in interest rates and changes in foreign currency exchange rates.
|
15.
|
|
Disruptions in the financial markets or changes in economic conditions that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable.
|
16.
|
|
The loss of, or price increases by, suppliers of key components, some of which are sole-sourced.
|
17.
|
|
Inability to successfully integrate the businesses that we have acquired in recent years and that we plan to acquire.
|
18.
|
|
Risks associated with our substantial international operations, including economic and political instability, currency fluctuations, changes in customs, tariffs and other trade restrictions and compliance with foreign laws.
|
19.
|
|
Our inability to realize the expected benefits from our restructuring initiatives and continuous improvement efforts and the negative unintended consequences such activity could have.
|
20.
|
|
Adverse developments in investigations and governmental proceedings.
|
21.
|
|
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 Biocor®, Epic™, Trifecta™ and Portico™ tissue heart valves or that impose added costs on the procurement of bovine collagen or bovine pericardial material.
|
22.
|
|
Severe weather or other natural disasters that can adversely impact customer purchasing patterns and/or patient implant procedures or 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, Puerto Rico and Costa Rica or a hurricane affecting our facilities in Puerto Rico and Malaysia.
|
23.
|
|
Our inability to maintain, protect and enhance our information and manufacturing systems and our products that incorporate information technology or to develop new systems and products as well as risks to the privacy and security of customer, patient, third-party payor, employee, supplier or company information from continually evolving cybersecurity threats.
|
24.
|
|
Changes in accounting rules or tax laws that adversely affect our results of operations, financial position or cash flows.
|
|
|
Item 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
|
Item 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
Fiscal Year Ended
|
January 3, 2015
|
|
December 28, 2013
|
|
December 29, 2012
|
||||||
Net sales
|
$
|
5,622
|
|
|
$
|
5,501
|
|
|
$
|
5,503
|
|
Cost of sales:
|
|
|
|
|
|
|
|
||||
Cost of sales before special charges
|
1,597
|
|
|
1,529
|
|
|
1,445
|
|
|||
Special charges
|
56
|
|
|
45
|
|
|
93
|
|
|||
Total cost of sales
|
1,653
|
|
|
1,574
|
|
|
1,538
|
|
|||
Gross profit
|
3,969
|
|
|
3,927
|
|
|
3,965
|
|
|||
Selling, general and administrative expense
|
1,856
|
|
|
1,805
|
|
|
1,803
|
|
|||
Research and development expense
|
692
|
|
|
691
|
|
|
676
|
|
|||
Amortization of intangible assets
|
89
|
|
|
79
|
|
|
88
|
|
|||
Special charges
|
181
|
|
|
301
|
|
|
298
|
|
|||
Operating profit
|
1,151
|
|
|
1,051
|
|
|
1,100
|
|
|||
Interest income
|
(5
|
)
|
|
(5
|
)
|
|
(5
|
)
|
|||
Interest expense
|
85
|
|
|
81
|
|
|
73
|
|
|||
Other (income) expense
|
3
|
|
|
191
|
|
|
27
|
|
|||
Other expense, net
|
83
|
|
|
267
|
|
|
95
|
|
|||
Earnings before income taxes and noncontrolling interest
|
1,068
|
|
|
784
|
|
|
1,005
|
|
|||
Income tax expense
|
113
|
|
|
92
|
|
|
253
|
|
|||
Net earnings before noncontrolling interest
|
955
|
|
|
692
|
|
|
752
|
|
|||
Less: Net loss attributable to noncontrolling interest
|
(47
|
)
|
|
(31
|
)
|
|
—
|
|
|||
Net earnings attributable to St. Jude Medical, Inc.
|
$
|
1,002
|
|
|
$
|
723
|
|
|
$
|
752
|
|
Net earnings per share attributable to St. Jude Medical, Inc.:
|
|
|
|
|
|
||||||
Basic
|
$
|
3.52
|
|
|
$
|
2.52
|
|
|
$
|
2.40
|
|
Diluted
|
$
|
3.46
|
|
|
$
|
2.49
|
|
|
$
|
2.39
|
|
Cash dividends declared per share:
|
$
|
1.08
|
|
|
$
|
1.00
|
|
|
$
|
0.92
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
||||
Basic
|
285.0
|
|
|
287.0
|
|
|
313.3
|
|
|||
Diluted
|
289.7
|
|
|
290.6
|
|
|
314.8
|
|
Fiscal Year Ended
|
January 3, 2015
|
|
December 28, 2013
|
|
December 29, 2012
|
||||||
Net earnings before noncontrolling interest
|
$
|
955
|
|
|
$
|
692
|
|
|
$
|
752
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
||||
Unrealized gain on available-for-sale securities, net of taxes of $2 million and $1 million, respectively
|
—
|
|
|
5
|
|
|
10
|
|
|||
Reclassification of realized gain on available-for-sale securities, net of taxes of $1 million, $5 million and $6 million, respectively
|
(2
|
)
|
|
(8
|
)
|
|
(8
|
)
|
|||
Unrealized gain on derivative financial instruments, net of taxes
|
—
|
|
|
3
|
|
|
—
|
|
|||
Foreign currency translation adjustment
|
(217
|
)
|
|
—
|
|
|
28
|
|
|||
Other comprehensive income (loss)
|
(219
|
)
|
|
—
|
|
|
30
|
|
|||
Total comprehensive income before noncontrolling interest
|
736
|
|
|
692
|
|
|
782
|
|
|||
Total comprehensive loss attributable to noncontrolling interest
|
(47
|
)
|
|
(31
|
)
|
|
—
|
|
|||
Total comprehensive income attributable to St. Jude Medical, Inc.
|
$
|
783
|
|
|
$
|
723
|
|
|
$
|
782
|
|
|
January 3, 2015
|
|
December 28, 2013
|
||||
ASSETS
|
|
|
|
|
|
||
Current Assets
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
1,442
|
|
|
$
|
1,373
|
|
Accounts receivable, less allowance for doubtful accounts
|
1,215
|
|
|
1,422
|
|
||
Inventories
|
784
|
|
|
708
|
|
||
Deferred income taxes
|
291
|
|
|
229
|
|
||
Other current assets
|
182
|
|
|
178
|
|
||
Total current assets
|
3,914
|
|
|
3,910
|
|
||
Property, Plant and Equipment
|
|
|
|
||||
Land, building and improvements
|
709
|
|
|
651
|
|
||
Machinery and equipment
|
1,616
|
|
|
1,674
|
|
||
Diagnostic equipment
|
450
|
|
|
474
|
|
||
Property, plant and equipment, at cost
|
2,775
|
|
|
2,799
|
|
||
Less: Accumulated depreciation
|
(1,432
|
)
|
|
(1,389
|
)
|
||
Net property, plant and equipment
|
1,343
|
|
|
1,410
|
|
||
Goodwill
|
3,532
|
|
|
3,524
|
|
||
Intangible assets, net
|
851
|
|
|
911
|
|
||
Deferred income taxes
|
113
|
|
|
116
|
|
||
Other assets
|
454
|
|
|
377
|
|
||
TOTAL ASSETS
|
$
|
10,207
|
|
|
$
|
10,248
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current Liabilities
|
|
|
|
|
|
||
Current debt obligations
|
$
|
1,593
|
|
|
$
|
62
|
|
Accounts payable
|
151
|
|
|
247
|
|
||
Dividends payable
|
77
|
|
|
72
|
|
||
Income taxes payable
|
60
|
|
|
32
|
|
||
Employee compensation and related benefits
|
292
|
|
|
312
|
|
||
Other current liabilities
|
493
|
|
|
655
|
|
||
Total current liabilities
|
2,666
|
|
|
1,380
|
|
||
Long-term debt
|
2,273
|
|
|
3,518
|
|
||
Deferred income taxes
|
240
|
|
|
240
|
|
||
Other liabilities
|
784
|
|
|
706
|
|
||
Total liabilities
|
5,963
|
|
|
5,844
|
|
||
Commitments and Contingencies (Note 5)
|
—
|
|
|
—
|
|
||
Shareholders’ Equity
|
|
|
|
|
|
||
Preferred stock ($1.00 par value; 25,000,000 shares authorized; none outstanding)
|
—
|
|
|
—
|
|
||
Common stock ($0.10 par value; 500,000,000 shares authorized; 286,659,901 and 289,117,352 shares issued and outstanding as of January 3, 2015 and December 28, 2013, respectively)
|
29
|
|
|
29
|
|
||
Additional paid-in capital
|
118
|
|
|
220
|
|
||
Retained earnings
|
4,225
|
|
|
3,936
|
|
||
Accumulated other comprehensive income (loss)
|
(173
|
)
|
|
46
|
|
||
Total shareholders' equity before noncontrolling interest
|
4,199
|
|
|
4,231
|
|
||
Noncontrolling interest
|
45
|
|
|
173
|
|
||
Total shareholders' equity
|
4,244
|
|
|
4,404
|
|
||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$
|
10,207
|
|
|
$
|
10,248
|
|
|
|
|
|
Accumulated
|
|
|
||||||||||||||
|
Common Stock
|
Additional
|
|
Other
|
|
Total
|
||||||||||||||
|
Number of
|
|
Paid-In
|
Retained
|
Comprehensive
|
Noncontrolling
|
Shareholders'
|
|||||||||||||
|
Shares
|
Amount
|
Capital
|
Earnings
|
Income (Loss)
|
Interest
|
Equity
|
|||||||||||||
Balance as of December 31, 2011
|
319,615,965
|
|
$
|
32
|
|
$
|
43
|
|
$
|
4,384
|
|
$
|
16
|
|
$
|
—
|
|
$
|
4,475
|
|
Net earnings
|
|
|
|
752
|
|
|
—
|
|
752
|
|
||||||||||
Other comprehensive income (loss)
|
|
|
|
|
30
|
|
—
|
|
30
|
|
||||||||||
Cash dividends declared
|
|
|
|
(284
|
)
|
|
|
(284
|
)
|
|||||||||||
Repurchases of common stock
|
(27,670,874
|
)
|
(3
|
)
|
(221
|
)
|
(834
|
)
|
|
|
(1,058
|
)
|
||||||||
Stock-based compensation
|
|
|
69
|
|
|
|
|
69
|
|
|||||||||||
Common stock issued under employee stock plans and other, net
|
3,703,236
|
|
1
|
|
118
|
|
|
|
|
119
|
|
|||||||||
Tax shortfall from stock plans
|
|
|
(9
|
)
|
|
|
|
(9
|
)
|
|||||||||||
Balance as of December 29, 2012
|
295,648,327
|
|
30
|
|
—
|
|
4,018
|
|
46
|
|
—
|
|
4,094
|
|
||||||
Net earnings
|
|
|
|
723
|
|
|
(31
|
)
|
692
|
|
||||||||||
Other comprehensive income (loss)
|
|
|
|
|
—
|
|
—
|
|
—
|
|
||||||||||
Cash dividends declared
|
|
|
|
(286
|
)
|
|
|
(286
|
)
|
|||||||||||
Repurchases of common stock
|
(18,385,436
|
)
|
(2
|
)
|
(287
|
)
|
(519
|
)
|
|
|
(808
|
)
|
||||||||
Stock-based compensation
|
|
|
65
|
|
|
|
|
65
|
|
|||||||||||
Common stock issued under employee stock plans and other, net
|
11,854,461
|
|
1
|
|
442
|
|
|
|
|
443
|
|
|||||||||
Additions in noncontrolling ownership interests
|
|
|
|
|
|
204
|
|
204
|
|
|||||||||||
Balance as of December 28, 2013
|
289,117,352
|
|
29
|
|
220
|
|
3,936
|
|
46
|
|
173
|
|
4,404
|
|
||||||
Net earnings
|
|
|
|
1,002
|
|
|
(47
|
)
|
955
|
|
||||||||||
Other comprehensive income (loss)
|
|
|
|
|
(219
|
)
|
—
|
|
(219
|
)
|
||||||||||
Cash dividends declared
|
|
|
|
(309
|
)
|
|
|
(309
|
)
|
|||||||||||
Repurchases of common stock
|
(6,670,817
|
)
|
(1
|
)
|
(247
|
)
|
(186
|
)
|
|
|
(434
|
)
|
||||||||
Stock-based compensation
|
|
|
69
|
|
|
|
2
|
|
71
|
|
||||||||||
Common stock issued under employee stock plans and other, net
|
4,213,366
|
|
1
|
|
134
|
|
|
|
|
135
|
|
|||||||||
Tax benefit from stock plans
|
|
|
21
|
|
|
|
|
21
|
|
|||||||||||
Measurement period fair value adjustment to noncontrolling interest
|
|
|
|
|
|
(36
|
)
|
(36
|
)
|
|||||||||||
Purchase of shares from noncontrolling ownership interest
|
|
|
(79
|
)
|
(218
|
)
|
|
(47
|
)
|
(344
|
)
|
|||||||||
Balance as of January 3, 2015
|
286,659,901
|
|
$
|
29
|
|
$
|
118
|
|
$
|
4,225
|
|
$
|
(173
|
)
|
$
|
45
|
|
$
|
4,244
|
|
Fiscal Year Ended
|
January 3, 2015
|
|
December 28, 2013
|
|
December 29, 2012
|
||||||
OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
||||
Net earnings before noncontrolling interest
|
$
|
955
|
|
|
$
|
692
|
|
|
$
|
752
|
|
Adjustments to reconcile net earnings before noncontrolling interest to net cash from operating activities:
|
|
|
|
|
|
|
|
||||
Depreciation of property, plant and equipment
|
221
|
|
|
218
|
|
|
196
|
|
|||
Amortization of intangible assets
|
89
|
|
|
79
|
|
|
88
|
|
|||
Amortization of debt premium, net
|
(5
|
)
|
|
(6
|
)
|
|
(11
|
)
|
|||
Inventory step-up amortization
|
5
|
|
|
4
|
|
|
—
|
|
|||
Contingent consideration fair value adjustments
|
22
|
|
|
1
|
|
|
—
|
|
|||
Payment of contingent consideration
|
(27
|
)
|
|
—
|
|
|
—
|
|
|||
Stock-based compensation
|
71
|
|
|
65
|
|
|
69
|
|
|||
Excess tax benefits from stock issued under employee stock plans
|
(21
|
)
|
|
(15
|
)
|
|
(1
|
)
|
|||
Gain on sale of investments
|
(3
|
)
|
|
(13
|
)
|
|
(14
|
)
|
|||
Loss on retirement of long-term debt
|
—
|
|
|
161
|
|
|
—
|
|
|||
Deferred income taxes
|
(87
|
)
|
|
(124
|
)
|
|
(77
|
)
|
|||
Other, net
|
84
|
|
|
75
|
|
|
106
|
|
|||
Changes in operating assets and liabilities, net of business combinations:
|
|
|
|
|
|
|
|
||||
Accounts receivable
|
112
|
|
|
(100
|
)
|
|
13
|
|
|||
Inventories
|
(102
|
)
|
|
(99
|
)
|
|
13
|
|
|||
Other current and noncurrent assets
|
(70
|
)
|
|
13
|
|
|
4
|
|
|||
Accounts payable and accrued expenses
|
(60
|
)
|
|
31
|
|
|
29
|
|
|||
Income taxes payable
|
120
|
|
|
(21
|
)
|
|
168
|
|
|||
Net cash provided by operating activities
|
1,304
|
|
|
961
|
|
|
1,335
|
|
|||
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
||||
Purchases of property, plant and equipment
|
(190
|
)
|
|
(222
|
)
|
|
(280
|
)
|
|||
Business combination payments, net of cash acquired
|
(147
|
)
|
|
(292
|
)
|
|
—
|
|
|||
Proceeds from sale of investments
|
7
|
|
|
10
|
|
|
19
|
|
|||
Other investing activities, net
|
(9
|
)
|
|
(18
|
)
|
|
(52
|
)
|
|||
Net cash used in investing activities
|
(339
|
)
|
|
(522
|
)
|
|
(313
|
)
|
|||
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
||||
Proceeds from exercise of stock options and stock issued, net
|
135
|
|
|
443
|
|
|
119
|
|
|||
Excess tax benefits from stock issued under employee stock plans
|
21
|
|
|
15
|
|
|
1
|
|
|||
Common stock repurchased, including related costs
|
(476
|
)
|
|
(833
|
)
|
|
(992
|
)
|
|||
Dividends paid
|
(303
|
)
|
|
(282
|
)
|
|
(284
|
)
|
|||
Issuances (payments) of commercial paper borrowings, net
|
75
|
|
|
121
|
|
|
321
|
|
|||
Borrowings under debt facilities
|
250
|
|
|
2,092
|
|
|
—
|
|
|||
Payments under debt facilities
|
(50
|
)
|
|
(1,659
|
)
|
|
—
|
|
|||
Purchase of shares from noncontrolling ownership interest
|
(344
|
)
|
|
—
|
|
|
—
|
|
|||
Payment of contingent consideration
|
(128
|
)
|
|
—
|
|
|
—
|
|
|||
Other financing activities, net
|
(7
|
)
|
|
(154
|
)
|
|
22
|
|
|||
Net cash used in financing activities
|
(827
|
)
|
|
(257
|
)
|
|
(813
|
)
|
|||
Effect of currency exchange rate changes on cash and cash equivalents
|
(69
|
)
|
|
(3
|
)
|
|
(1
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
69
|
|
|
179
|
|
|
208
|
|
|||
Cash and cash equivalents at beginning of period
|
1,373
|
|
|
1,194
|
|
|
986
|
|
|||
Cash and cash equivalents at end of period
|
$
|
1,442
|
|
|
$
|
1,373
|
|
|
$
|
1,194
|
|
|
|
|
|
|
|
||||||
Supplemental Cash Flow Information
|
|
|
|
|
|
||||||
Cash paid during the year for:
|
|
|
|
|
|
||||||
Income taxes
|
$
|
140
|
|
|
$
|
246
|
|
|
$
|
177
|
|
Interest
|
$
|
85
|
|
|
$
|
95
|
|
|
$
|
69
|
|
Noncash investing and financing activities:
|
|
|
|
|
|
||||||
Additions in noncontrolling ownership interests
|
$
|
(36
|
)
|
|
$
|
204
|
|
|
$
|
—
|
|
Fair value of acquisition contingent consideration
|
$
|
—
|
|
|
$
|
188
|
|
|
$
|
—
|
|
|
January 3, 2015
|
|
December 28, 2013
|
||||
Adjusted cost
|
$
|
6
|
|
|
$
|
7
|
|
Gross unrealized gains
|
24
|
|
|
28
|
|
||
Fair value
|
$
|
30
|
|
|
$
|
35
|
|
|
January 3, 2015
|
|
December 28, 2013
|
||||
Finished goods
|
$
|
543
|
|
|
$
|
494
|
|
Work in process
|
77
|
|
|
52
|
|
||
Raw materials
|
164
|
|
|
162
|
|
||
Inventories
|
$
|
784
|
|
|
$
|
708
|
|
|
2014
|
|
2013
|
||||
Balance at beginning of period
|
$
|
37
|
|
|
$
|
38
|
|
Warranty expense recognized
|
3
|
|
|
3
|
|
||
Warranty credits issued
|
(5
|
)
|
|
(4
|
)
|
||
Balance at end of period
|
$
|
35
|
|
|
$
|
37
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Numerator:
|
|
|
|
|
|
|
|||||
Net earnings attributable to St. Jude Medical, Inc.
|
$
|
1,002
|
|
|
$
|
723
|
|
|
$
|
752
|
|
Denominator:
|
|
|
|
|
|
|
|||||
Basic weighted average shares outstanding
|
285.0
|
|
|
287.0
|
|
|
313.3
|
|
|||
Dilution associated with stock-based compensation plans
|
4.7
|
|
|
3.6
|
|
|
1.5
|
|
|||
Diluted weighted average shares outstanding
|
289.7
|
|
|
290.6
|
|
|
314.8
|
|
|||
Basic net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
3.52
|
|
|
$
|
2.52
|
|
|
$
|
2.40
|
|
Diluted net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
3.46
|
|
|
$
|
2.49
|
|
|
$
|
2.39
|
|
|
|
NeuroTherm
|
||
Current assets
|
|
$
|
22
|
|
Property, plant and equipment
|
|
2
|
|
|
Goodwill
|
|
125
|
|
|
Intangible assets
|
|
89
|
|
|
Current liabilities
|
|
(13
|
)
|
|
Deferred income tax assets/(liabilities)
|
|
(28
|
)
|
|
Long-term debt
|
|
(50
|
)
|
|
Net assets
|
|
$
|
147
|
|
|
|
|
||
Cash paid
|
|
$
|
148
|
|
Less: Cash acquired
|
|
(1
|
)
|
|
Net cash consideration
|
|
$
|
147
|
|
|
|
January 3, 2015
|
||
Cash and cash equivalents
|
|
$
|
9
|
|
Other current assets
|
|
7
|
|
|
Goodwill
|
|
46
|
|
|
IPR&D
|
|
45
|
|
|
Other intangible assets
|
|
7
|
|
|
Total assets
|
|
$
|
114
|
|
|
|
|
||
Current liabilities
|
|
$
|
5
|
|
Deferred income taxes
|
|
19
|
|
|
Total liabilities
|
|
24
|
|
|
|
|
|
||
Non-controlling interest
|
|
$
|
45
|
|
|
|
Endosense
|
Nanostim
|
Spinal Modulation
|
CardioMEMS
|
||||||||
Cash and cash equivalents
|
|
$
|
—
|
|
$
|
—
|
|
$
|
41
|
|
$
|
33
|
|
Current assets
|
|
2
|
|
1
|
|
9
|
|
3
|
|
||||
Goodwill
|
|
258
|
|
149
|
|
46
|
|
83
|
|
||||
In-process research and development (IPR&D)
|
|
33
|
|
27
|
|
45
|
|
63
|
|
||||
Other intangible assets
|
|
20
|
|
34
|
|
7
|
|
—
|
|
||||
Other assets
|
|
1
|
|
1
|
|
1
|
|
2
|
|
||||
Current liabilities
|
|
(11
|
)
|
(2
|
)
|
(6
|
)
|
(13
|
)
|
||||
Deferred income tax assets/(liabilities)
|
|
—
|
|
—
|
|
(19
|
)
|
(23
|
)
|
||||
Other liabilities
|
|
—
|
|
—
|
|
—
|
|
(5
|
)
|
||||
Net assets
|
|
$
|
303
|
|
$
|
210
|
|
$
|
124
|
|
$
|
143
|
|
|
|
|
|
|
|
||||||||
Cash paid
|
|
$
|
180
|
|
$
|
124
|
|
$
|
—
|
|
$
|
—
|
|
Less: Cash acquired
|
|
(9
|
)
|
(3
|
)
|
—
|
|
—
|
|
||||
Net cash consideration
|
|
$
|
171
|
|
$
|
121
|
|
$
|
—
|
|
$
|
—
|
|
Contingent consideration
|
|
132
|
|
56
|
|
—
|
|
—
|
|
||||
Fair value of St. Jude Medical, Inc.'s previously held interest
|
|
—
|
|
33
|
|
—
|
|
31
|
|
||||
Acquisition of controlling ownership interest
|
|
—
|
|
—
|
|
40
|
|
—
|
|
||||
Debt financing
|
|
—
|
|
—
|
|
—
|
|
28
|
|
||||
Additions in noncontrolling ownership interest
|
|
—
|
|
—
|
|
84
|
|
84
|
|
||||
Total purchase consideration
|
|
$
|
303
|
|
$
|
210
|
|
$
|
124
|
|
$
|
143
|
|
Balance as of December 29, 2012
|
$
|
2,961
|
|
Endosense
|
258
|
|
|
Nanostim
|
149
|
|
|
Spinal Modulation
|
82
|
|
|
CardioMEMS
|
83
|
|
|
Foreign currency translation and other
|
(9
|
)
|
|
Balance as of December 28, 2013
|
3,524
|
|
|
NeuroTherm
|
125
|
|
|
Spinal Modulation
|
(36
|
)
|
|
Foreign currency translation and other
|
(81
|
)
|
|
Balance as of January 3, 2015
|
$
|
3,532
|
|
|
January 3, 2015
|
|
December 28, 2013
|
||||||||||||
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
||||||||
Definite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Purchased technology and patents
|
$
|
1,162
|
|
|
$
|
473
|
|
|
$
|
986
|
|
|
$
|
393
|
|
Customer lists and relationships
|
19
|
|
|
14
|
|
|
20
|
|
|
13
|
|
||||
Trademarks and tradenames
|
22
|
|
|
13
|
|
|
22
|
|
|
11
|
|
||||
Licenses, distribution agreements and other
|
7
|
|
|
2
|
|
|
4
|
|
|
1
|
|
||||
|
$
|
1,210
|
|
|
$
|
502
|
|
|
$
|
1,032
|
|
|
$
|
418
|
|
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Acquired IPR&D
|
$
|
116
|
|
|
|
|
|
$
|
262
|
|
|
|
|
||
Trademarks and tradenames
|
27
|
|
|
|
|
|
35
|
|
|
|
|
||||
|
$
|
143
|
|
|
|
|
|
$
|
297
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
After
|
||||||||||||
|
2015
|
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
2019
|
||||||||||||
Amortization expense
|
$
|
98
|
|
|
$
|
99
|
|
|
$
|
87
|
|
|
$
|
88
|
|
|
$
|
86
|
|
|
$
|
366
|
|
|
January 3, 2015
|
|
December 28, 2013
|
||||
Term loan due June 2015
|
$
|
500
|
|
|
$
|
500
|
|
Term loan due August 2015
|
250
|
|
|
—
|
|
||
2.50% senior notes due 2016
|
506
|
|
|
512
|
|
||
3.25% senior notes due 2023
|
896
|
|
|
896
|
|
||
4.75% senior notes due 2043
|
696
|
|
|
696
|
|
||
1.58% Yen-denominated senior notes due 2017
|
68
|
|
|
78
|
|
||
2.04% Yen-denominated senior notes due 2020
|
107
|
|
|
122
|
|
||
Yen-denominated credit facilities
|
54
|
|
|
62
|
|
||
Commercial paper borrowings
|
789
|
|
|
714
|
|
||
Total debt
|
3,866
|
|
|
3,580
|
|
||
Less: current debt obligations
|
1,593
|
|
|
62
|
|
||
Long-term debt
|
$
|
2,273
|
|
|
$
|
3,518
|
|
|
2015
|
2016
|
2017
|
2018
|
2019
|
After 2019
|
||||||||||||
Expected future minimum principal payments
|
$
|
1,593
|
|
$
|
500
|
|
$
|
68
|
|
$
|
—
|
|
$
|
—
|
|
$
|
1,707
|
|
|
|
|
|
|
|
|
|
|
|
|
After
|
||||||||||||
|
2015
|
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
2019
|
||||||||||||
Future minimum operating lease payments
|
$
|
35
|
|
|
$
|
28
|
|
|
$
|
23
|
|
|
$
|
18
|
|
|
$
|
11
|
|
|
$
|
7
|
|
|
Unrealized
|
Unrealized
|
Foreign
|
Accumulated
|
||||||||
|
Gain (Loss) On
|
Gain (Loss) On
|
Currency
|
Other
|
||||||||
|
Available-for-sale
|
Derivative
|
Translation
|
Comprehensive
|
||||||||
|
Securities
|
Instruments
|
Adjustment
|
Income
|
||||||||
Accumulated other comprehensive income (loss) as of December 31, 2011
|
$
|
18
|
|
$
|
—
|
|
$
|
(2
|
)
|
$
|
16
|
|
Other comprehensive income (loss) before reclassifications
|
10
|
|
—
|
|
28
|
|
38
|
|
||||
Amounts reclassified to net earnings from accumulated other comprehensive income
|
(8
|
)
|
—
|
|
—
|
|
(8
|
)
|
||||
Other comprehensive income (loss)
|
2
|
|
—
|
|
28
|
|
30
|
|
||||
Accumulated other comprehensive income (loss) as of December 29, 2012
|
20
|
|
—
|
|
26
|
|
46
|
|
||||
Other comprehensive income (loss) before reclassifications
|
5
|
|
3
|
|
—
|
|
8
|
|
||||
Amounts reclassified to net earnings from accumulated other comprehensive income
|
(8
|
)
|
—
|
|
—
|
|
(8
|
)
|
||||
Other comprehensive income (loss)
|
(3
|
)
|
3
|
|
—
|
|
—
|
|
||||
Accumulated other comprehensive income (loss) as of December 28, 2013
|
17
|
|
3
|
|
26
|
|
46
|
|
||||
Other comprehensive income (loss) before reclassifications
|
—
|
|
—
|
|
(217
|
)
|
(217
|
)
|
||||
Amounts reclassified to net earnings from accumulated other comprehensive income
|
(2
|
)
|
—
|
|
—
|
|
(2
|
)
|
||||
Other comprehensive income (loss)
|
(2
|
)
|
—
|
|
(217
|
)
|
(219
|
)
|
||||
Accumulated other comprehensive income (loss) as of January 3, 2015
|
$
|
15
|
|
$
|
3
|
|
$
|
(191
|
)
|
$
|
(173
|
)
|
Details about
|
Amounts reclassified from accumulated other comprehensive income
|
|
||||||||
accumulated other comprehensive income components
|
2014
|
2013
|
2012
|
Statements of Earnings Classification
|
||||||
Unrealized gain on available-for-sale securities:
|
|
|||||||||
Gain on sale of available-for-sale securities
|
$
|
3
|
|
$
|
13
|
|
$
|
14
|
|
Other (income) expense
|
Tax effect
|
(1
|
)
|
(5
|
)
|
(6
|
)
|
Income tax expense
|
|||
Net of tax
|
$
|
2
|
|
$
|
8
|
|
$
|
8
|
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Cost of sales
|
$
|
6
|
|
|
$
|
5
|
|
|
$
|
5
|
|
Selling, general and administrative expense
|
49
|
|
|
45
|
|
|
49
|
|
|||
Research and development expense
|
16
|
|
|
15
|
|
|
15
|
|
|||
Stock-based compensation expense
|
$
|
71
|
|
|
$
|
65
|
|
|
$
|
69
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Fair value of options granted
|
$
|
14.56
|
|
|
$
|
13.83
|
|
|
$
|
7.71
|
|
Assumptions:
|
|
|
|
|
|
||||||
Expected life (years)
|
5.4
|
|
|
5.4
|
|
|
5.4
|
|
|||
Risk-free interest rate
|
1.7
|
%
|
|
1.6
|
%
|
|
0.7
|
%
|
|||
Volatility
|
24.9
|
%
|
|
28.6
|
%
|
|
31.2
|
%
|
|||
Dividend yield
|
1.6
|
%
|
|
1.8
|
%
|
|
2.5
|
%
|
|
|
|
|
|
Weighted
|
|
|
|||||
|
|
|
Weighted
|
|
Average
|
|
Aggregate
|
|||||
|
|
|
Average
|
|
Remaining
|
|
Intrinsic
|
|||||
|
Options
|
|
Exercise
|
|
Contractual
|
|
Value
|
|||||
|
(shares in millions)
|
|
Price
|
|
Term (in years)
|
|
(in millions)
|
|||||
Outstanding as of December 28, 2013
|
18.9
|
|
|
$
|
39.94
|
|
|
|
|
|
||
Granted
|
2.6
|
|
|
69.08
|
|
|
|
|
|
|||
Exercised
|
(3.2
|
)
|
|
37.09
|
|
|
|
|
|
|||
Forfeited and expired
|
(0.6
|
)
|
|
41.50
|
|
|
|
|
|
|||
Outstanding as of January 3, 2015
|
17.7
|
|
|
$
|
44.70
|
|
|
5.0
|
|
$
|
368
|
|
Vested and expected to vest
|
17.0
|
|
|
$
|
44.11
|
|
|
4.9
|
|
$
|
362
|
|
Exercisable as of January 3, 2015
|
10.5
|
|
|
$
|
38.38
|
|
|
3.8
|
|
$
|
279
|
|
|
Restricted Stock
|
|
Weighted Average
|
|||
|
Units and Awards
|
|
Grant Date
|
|||
|
(shares in millions)
|
|
Fair Value
|
|||
Unvested balance as of December 28, 2013
|
1.6
|
|
|
$
|
45.98
|
|
Granted
|
0.6
|
|
|
68.89
|
|
|
Vested
|
(0.6
|
)
|
|
44.31
|
|
|
Forfeited
|
(0.1
|
)
|
|
44.43
|
|
|
Unvested balance as of January 3, 2015
|
1.5
|
|
|
$
|
56.36
|
|
|
Employee
Termination Costs |
|
Inventory
Charges |
|
Fixed
Asset Charges |
|
Other Restructuring Costs
|
|
Total
|
||||||||||
Balance as of December 28, 2013
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cost of sales special charges
|
7
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7
|
|
|||||
Special charges
|
12
|
|
|
—
|
|
|
5
|
|
|
8
|
|
|
25
|
|
|||||
Non-cash charges used
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
—
|
|
|
(5
|
)
|
|||||
Cash payments
|
(5
|
)
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
(7
|
)
|
|||||
Balance as of January 3, 2015
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6
|
|
|
$
|
20
|
|
|
Employee
Termination
Costs
|
|
Inventory
Charges
|
|
Fixed
Asset
Charges
|
|
Other Restructuring Costs
|
|
Total
|
||||||||||
Balance as of December 31, 2011
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cost of sales special charges
|
5
|
|
|
17
|
|
|
—
|
|
|
2
|
|
|
24
|
|
|||||
Special charges
|
104
|
|
|
—
|
|
|
41
|
|
|
16
|
|
|
161
|
|
|||||
Non-cash charges used
|
—
|
|
|
(17
|
)
|
|
(41
|
)
|
|
(3
|
)
|
|
(61
|
)
|
|||||
Cash payments
|
(52
|
)
|
|
—
|
|
|
—
|
|
|
(7
|
)
|
|
(59
|
)
|
|||||
Foreign exchange rate impact
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Balance as of December 29, 2012
|
58
|
|
|
—
|
|
|
—
|
|
|
8
|
|
|
66
|
|
|||||
Cost of sales special charges
|
—
|
|
|
30
|
|
|
—
|
|
|
5
|
|
|
35
|
|
|||||
Special charges
|
75
|
|
|
—
|
|
|
13
|
|
|
97
|
|
|
185
|
|
|||||
Non-cash charges used
|
—
|
|
|
(30
|
)
|
|
(13
|
)
|
|
(4
|
)
|
|
(47
|
)
|
|||||
Cash payments
|
(79
|
)
|
|
—
|
|
|
—
|
|
|
(73
|
)
|
|
(152
|
)
|
|||||
Balance as of December 28, 2013
|
54
|
|
|
—
|
|
|
—
|
|
|
33
|
|
|
87
|
|
|||||
Cost of sales special charges
|
8
|
|
|
8
|
|
|
13
|
|
|
1
|
|
|
30
|
|
|||||
Special charges
|
36
|
|
|
—
|
|
|
7
|
|
|
35
|
|
|
78
|
|
|||||
Non-cash charges used
|
—
|
|
|
(8
|
)
|
|
(20
|
)
|
|
—
|
|
|
(28
|
)
|
|||||
Cash payments
|
(69
|
)
|
|
—
|
|
|
—
|
|
|
(56
|
)
|
|
(125
|
)
|
|||||
Foreign exchange rate impact
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
(4
|
)
|
|||||
Balance as of January 3, 2015
|
$
|
26
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12
|
|
|
$
|
38
|
|
|
Employee
Termination
Costs
|
|
Inventory
Charges
|
|
Fixed
Asset
Charges
|
|
Other Restructuring Costs
|
|
Total
|
||||||||||
Balance as of December 31, 2011
|
$
|
54
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18
|
|
|
$
|
72
|
|
Cost of sales special charges
|
11
|
|
|
13
|
|
|
—
|
|
|
20
|
|
|
44
|
|
|||||
Special charges
|
27
|
|
|
—
|
|
|
—
|
|
|
31
|
|
|
58
|
|
|||||
Non-cash charges used
|
—
|
|
|
(13
|
)
|
|
—
|
|
|
(4
|
)
|
|
(17
|
)
|
|||||
Cash payments
|
(68
|
)
|
|
—
|
|
|
—
|
|
|
(47
|
)
|
|
(115
|
)
|
|||||
Foreign exchange rate impact
|
1
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|||||
Balance as of December 29, 2012
|
25
|
|
|
—
|
|
|
—
|
|
|
17
|
|
|
42
|
|
|||||
Special charges
|
5
|
|
|
—
|
|
|
1
|
|
|
18
|
|
|
24
|
|
|||||
Non-cash charges used
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|||||
Cash payments
|
(21
|
)
|
|
—
|
|
|
—
|
|
|
(29
|
)
|
|
(50
|
)
|
|||||
Balance as of December 28, 2013
|
9
|
|
|
—
|
|
|
—
|
|
|
6
|
|
|
15
|
|
|||||
Cash payments
|
(9
|
)
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|
(13
|
)
|
|||||
Balance as of January 3, 2015
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2
|
|
|
$
|
2
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
U.S.
|
$
|
157
|
|
|
$
|
(17
|
)
|
|
$
|
316
|
|
International
|
911
|
|
|
801
|
|
|
689
|
|
|||
Earnings before income taxes and noncontrolling interest
|
$
|
1,068
|
|
|
$
|
784
|
|
|
$
|
1,005
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Current:
|
|
|
|
|
|
||||||
U.S. federal
|
$
|
150
|
|
|
$
|
101
|
|
|
$
|
236
|
|
U.S. state and other
|
11
|
|
|
7
|
|
|
16
|
|
|||
International
|
39
|
|
|
108
|
|
|
78
|
|
|||
Total current
|
200
|
|
|
216
|
|
|
330
|
|
|||
Deferred
|
(87
|
)
|
|
(124
|
)
|
|
(77
|
)
|
|||
Income tax expense
|
$
|
113
|
|
|
$
|
92
|
|
|
$
|
253
|
|
|
2014
|
|
2013
|
||||
Deferred income tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
415
|
|
|
$
|
402
|
|
Tax credit carryforwards
|
119
|
|
|
75
|
|
||
Inventories
|
134
|
|
|
136
|
|
||
Stock-based compensation
|
46
|
|
|
47
|
|
||
Compensation and benefits
|
131
|
|
|
123
|
|
||
R&D expenditures, capitalized for tax
|
92
|
|
|
112
|
|
||
Accrued liabilities and other
|
129
|
|
|
130
|
|
||
|
1,066
|
|
|
1,025
|
|
||
Less: valuation allowance
|
(400
|
)
|
|
(368
|
)
|
||
Deferred income tax assets, net
|
666
|
|
|
657
|
|
||
Deferred income tax liabilities:
|
|
|
|
||||
Unrealized gain on available-for-sale securities
|
(9
|
)
|
|
(11
|
)
|
||
Property, plant and equipment
|
(171
|
)
|
|
(189
|
)
|
||
Intangible assets
|
(322
|
)
|
|
(352
|
)
|
||
Deferred income tax liabilities
|
(502
|
)
|
|
(552
|
)
|
||
Net deferred income tax assets (liabilities)
|
$
|
164
|
|
|
$
|
105
|
|
|
2014
|
|
2013
|
|
2012
|
|||
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
|
0.2
|
|
|
0.6
|
|
|
0.5
|
|
International taxes at lower rates
|
(19.6
|
)
|
|
(13.6
|
)
|
|
(12.1
|
)
|
Tax benefits from domestic manufacturer's deduction
|
(1.2
|
)
|
|
(1.9
|
)
|
|
(2.2
|
)
|
Research and development credits
|
(2.8
|
)
|
|
(4.6
|
)
|
|
(1.1
|
)
|
Puerto Rico excise tax
|
(1.7
|
)
|
|
(3.0
|
)
|
|
(1.8
|
)
|
Tax settlements
|
—
|
|
|
(1.9
|
)
|
|
4.6
|
|
Noncontrolling interest
|
1.8
|
|
|
3.6
|
|
|
—
|
|
Other
|
(1.1
|
)
|
|
(2.5
|
)
|
|
2.3
|
|
Effective income tax rate
|
10.6
|
%
|
|
11.7
|
%
|
|
25.2
|
%
|
|
2014
|
|
2013
|
|
2011
|
||||||
Balance at beginning of year
|
$
|
315
|
|
|
$
|
314
|
|
|
$
|
205
|
|
Increases related to current year tax positions
|
67
|
|
|
74
|
|
|
38
|
|
|||
Increases related to prior year tax positions
|
6
|
|
|
33
|
|
|
90
|
|
|||
Reductions related to prior year tax positions
|
(27
|
)
|
|
(16
|
)
|
|
(18
|
)
|
|||
Reductions related to settlements / payments
|
(27
|
)
|
|
(90
|
)
|
|
(1
|
)
|
|||
Expiration of the statute of limitations for the assessment of taxes
|
(6
|
)
|
|
—
|
|
|
—
|
|
|||
Balance at end of year
|
$
|
328
|
|
|
$
|
315
|
|
|
$
|
314
|
|
•
|
Level 1 – Inputs to the fair value measurement are quoted prices in active markets for identical assets or liabilities.
|
•
|
Level 2 – Inputs to the fair value measurement include quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly.
|
•
|
Level 3 – Inputs to the fair value measurement are unobservable inputs or valuation techniques.
|
|
Balance Sheet
Classification
|
January 3, 2015
|
|
Quoted Prices
In Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money-market securities
|
Cash and cash equivalents
|
$
|
729
|
|
|
$
|
729
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale securities
|
Other current assets
|
30
|
|
|
30
|
|
|
—
|
|
|
—
|
|
||||
Trading securities
|
Other assets
|
301
|
|
|
301
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
|
$
|
1,060
|
|
|
$
|
1,060
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
Other liabilities
|
$
|
50
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50
|
|
Total liabilities
|
|
$
|
50
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50
|
|
|
Balance Sheet
Classification
|
December 28, 2013
|
|
Quoted Prices
In Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money-market securities
|
Cash and cash equivalents
|
$
|
875
|
|
|
$
|
875
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale securities
|
Other current assets
|
35
|
|
|
35
|
|
|
—
|
|
|
—
|
|
||||
Trading securities
|
Other assets
|
279
|
|
|
279
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
|
$
|
1,189
|
|
|
$
|
1,189
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
Other liabilities
|
$
|
195
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
195
|
|
Total liabilities
|
|
$
|
195
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
195
|
|
Contingent Consideration Liability
|
Fair Value as of January 3, 2015
|
Valuation Technique
|
|
Unobservable Inputs
|
||||||
|
|
|
|
|
|
|
|
|
||
Nanostim regulatory-based milestone
|
$
|
50
|
|
Probability Weighted Discounted Cash Flow
|
|
Discount Rate
|
|
|
|
5.00%
|
|
|
|
|
Probability of Payment
|
|
|
|
95%
|
||
|
|
|
|
Projected Years of Three Annual Payments
|
|
2016, 2017, 2018
|
||||
Total contingent consideration liability
|
$
|
50
|
|
|
|
|
|
|
|
|
|
Endosense
|
Nanostim
|
Total
|
||||||
Balance as of December 29, 2012
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
Purchase price contingent consideration
|
132
|
|
56
|
|
188
|
|
|||
Change in fair value of contingent consideration
|
1
|
|
—
|
|
1
|
|
|||
Foreign currency translation
|
6
|
|
—
|
|
6
|
|
|||
Balance as of December 28, 2013
|
139
|
|
56
|
|
195
|
|
|||
Change in fair value of contingent consideration
|
28
|
|
(6
|
)
|
22
|
|
|||
Payment of contingent consideration
|
(155
|
)
|
—
|
|
(155
|
)
|
|||
Foreign currency translation
|
(12
|
)
|
—
|
|
(12
|
)
|
|||
Balance as of January 3, 2015
|
$
|
—
|
|
$
|
50
|
|
$
|
50
|
|
Net Sales
|
2014
|
|
2013
|
|
2012
|
||||||
ICD Systems
|
$
|
1,746
|
|
|
$
|
1,741
|
|
|
$
|
1,743
|
|
Pacemaker Systems
|
1,047
|
|
|
1,042
|
|
|
1,111
|
|
|||
Atrial Fibrillation Products
|
1,044
|
|
|
957
|
|
|
898
|
|
|||
Vascular Products
|
709
|
|
|
704
|
|
|
716
|
|
|||
Structural Heart Products
|
639
|
|
|
631
|
|
|
612
|
|
|||
Neuromodulation Products
|
437
|
|
|
426
|
|
|
423
|
|
|||
Net sales
|
$
|
5,622
|
|
|
$
|
5,501
|
|
|
$
|
5,503
|
|
Net Sales
|
2014
|
|
2013
|
|
2012
|
||||||
United States
|
$
|
2,657
|
|
|
$
|
2,596
|
|
|
$
|
2,594
|
|
Japan
|
526
|
|
|
567
|
|
|
665
|
|
|||
Other foreign countries
|
2,439
|
|
|
2,338
|
|
|
2,244
|
|
|||
Net sales
|
$
|
5,622
|
|
|
$
|
5,501
|
|
|
$
|
5,503
|
|
Long-Lived Assets
|
January 3, 2015
|
|
December 28, 2013
|
|
December 29, 2012
|
||||||
United States
|
$
|
1,005
|
|
|
$
|
1,045
|
|
|
$
|
1,036
|
|
Other foreign countries
|
338
|
|
|
365
|
|
|
389
|
|
|||
Total long-lived assets
|
$
|
1,343
|
|
|
$
|
1,410
|
|
|
$
|
1,425
|
|
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
|
||||||||
(in millions, except per share amounts)
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Fiscal Year 2014:
|
|
|
|
|
|
|
|
|
||||||||
Net sales
|
$
|
1,363
|
|
|
$
|
1,448
|
|
|
$
|
1,372
|
|
|
$
|
1,439
|
|
|
Gross profit
|
980
|
|
|
1,015
|
|
|
960
|
|
|
1,014
|
|
|
||||
Net earnings before noncontrolling interest
|
239
|
|
|
246
|
|
|
232
|
|
|
238
|
|
|
||||
Net earnings attributable to St. Jude Medical, Inc.
|
249
|
|
|
270
|
|
|
238
|
|
|
245
|
|
|
||||
Basic net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
0.88
|
|
|
$
|
0.95
|
|
|
$
|
0.83
|
|
|
$
|
0.86
|
|
|
Diluted net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
0.86
|
|
|
$
|
0.93
|
|
|
$
|
0.82
|
|
|
$
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Fiscal Year 2013:
|
|
|
|
|
|
|
|
|
||||||||
Net sales
|
$
|
1,338
|
|
|
$
|
1,403
|
|
|
$
|
1,338
|
|
|
$
|
1,422
|
|
|
Gross profit
|
961
|
|
|
1,021
|
|
|
953
|
|
|
992
|
|
|
||||
Net earnings before noncontrolling interest
|
222
|
|
|
107
|
|
|
252
|
|
|
111
|
|
|
||||
Net earnings attributable to St. Jude Medical, Inc.
|
223
|
|
|
115
|
|
|
262
|
|
|
123
|
|
|
||||
Basic net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
0.78
|
|
|
$
|
0.41
|
|
|
$
|
0.91
|
|
|
$
|
0.42
|
|
|
Diluted net earnings per share attributable to St. Jude Medical, Inc.
|
$
|
0.78
|
|
|
$
|
0.40
|
|
|
$
|
0.90
|
|
|
$
|
0.42
|
|
|
|
|
Item 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
|
|
Item 9A.
|
CONTROLS AND PROCEDURES
|
|
|
Item 9B.
|
OTHER INFORMATION
|
|
|
Item 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
|
|
Item 11.
|
EXECUTIVE COMPENSATION
|
|
|
Item 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
Plan Category
|
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights (a)
(1)
|
|
Weighted-average exercise price of outstanding options, warrants and rights (b)
|
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
(2)
|
Stock plans approved by shareholders
(3)
|
|
17,644,526
|
|
$44.75
|
|
12,221,918
|
|
|
|
|
|
|
|
St. Jude Medical, Inc. 2007 Employee Stock Purchase Plan approved by shareholders
|
|
—
|
|
—
|
|
5,164,259
|
|
|
|
|
|
|
|
All equity compensation plans approved by shareholders
|
|
17,644,526
|
|
$44.75
|
|
17,386,177
|
|
|
|
|
|
|
|
Equity compensation plans not approved by shareholders
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
Total
|
|
17,644,526
|
|
$44.75
|
|
17,386,177
|
(1)
|
Excludes, as of January 3, 2015, 7,995 shares underlying outstanding stock options assumed by us in connection with our acquisition of Advanced Neuromodulation Systems, Inc. (ANS) which were originally granted pursuant to the following plans of ANS: the Quest Medical, Inc. 1995 Stock Option Plan, the Quest Medical, Inc. 1998 Stock Option Plan, the ANS 2000 Stock Option Plan, the ANS 2001 Employee Stock Option Plan, the ANS 2002 Stock Option Plan and the ANS 2004 Stock Incentive Plan. The options are administered pursuant to the terms of the plan under which they were originally granted. No future options will be granted under these acquired plans.
|
(2)
|
The shares available for future issuance as of January 3, 2015 included 107,439 shares available for restricted stock grants under the St. Jude Medical, Inc. 2000 Stock Plan, as amended; and, if all remaining shares authorized for issuance under the 2007 Stock Incentive Plan, as amended and restated, were allocated to full value awards such that no additional stock options could be granted under the 2007 Stock Incentive Plan, up to 4,805,944 shares available for full value awards under the 2007 Stock Incentive Plan.
|
(3)
|
Includes the St. Jude Medical, Inc. 1997 Stock Option Plan, as amended, the St. Jude Medical, Inc. 2000 Stock Plan, as amended, the St. Jude Medical, Inc. 2002 Stock Plan, as amended, the St. Jude Medical, Inc. 2006 Stock Plan, as amended, and the St. Jude Medical, Inc. 2007 Stock Incentive Plan, as amended and restated.
|
|
|
Item 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
|
|
Item 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
|
|
Item 15.
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
|
(a)
|
|
List of documents filed as part of this Report
|
Page
|
|||
|
|
(1
|
)
|
|
Financial Statements
|
|
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
|
|
|||
|
|
(2
|
)
|
|
Financial Statement Schedules
|
|
|
|
|
|
|||
|
|
|
|
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
|
|
|
|
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 to St. Jude Medical’s Current Report on Form 8-K filed on March 2, 2005.
|
|
|
|
4.1
|
|
Specimen Common Stock Certificate is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Registration Statement on Form S-4 filed October 20, 2010 (Commission File No. 333-170045).
|
|
|
|
4.2
|
|
Indenture, dated as of July 28, 2009, between St. Jude Medical, Inc. and U.S. Bank National Association, as Trustee, is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Current Report on Form 8-K filed on July 28, 2009.
|
|
|
|
4.3
|
|
First Supplemental Indenture, dated as of July 28, 2009, between St. Jude Medical, Inc. and U.S. Bank National Association, as Trustee, is incorporated by reference to Exhibit 4.2 to St. Jude Medical’s Current Report on Form 8-K filed on July 28, 2009.
|
|
|
|
4.4
|
|
Second Supplemental Indenture, dated as of March 17, 2010, between the Company and U.S. Bank National Association, as Trustee, is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Current Report on Form 8-K filed on March 19, 2010.
|
|
|
|
4.5
|
|
Third Supplemental Indenture, dated as of December 6, 2010, between the Company and U.S. Bank National Association, as Trustee, is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Current Report on Form 8-K filed on December 6, 2010.
|
|
|
|
4.6
|
|
Fourth Supplemental Indenture of Trust, dated as of April 2, 2013, between the Company and U.S. Bank National Association, as Trustee, is incorporated by reference to Exhibit 4.1 to St. Jude Medical’s Current Report on Form 8-K filed on April 2, 2013.
|
|
|
|
10.1
|
|
Form of Indemnification Agreement that St. Jude Medical has entered into with executive officers is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Annual Report on Form 10-K for the year ended January 1, 2011.
|
|
|
|
10.2
|
|
Form of Indemnification Agreement that St. Jude Medical has entered into with directors is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Annual Report on Form 10-K for the year ended January 1, 2011.
|
|
|
|
10.3
|
|
St. Jude Medical, Inc. Management Incentive Compensation Plan is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on May 6, 2014. *
|
|
|
|
10.4
|
|
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. *
|
|
|
|
10.5
|
|
First Amendment to the St. Jude Medical, Inc. Management Savings Plan is incorporated by reference to Exhibit 4.2 to St. Jude Medical's Registration Statement on Form S-8 filed on August 8, 2012 (Commission File No. 333-183158). *
|
|
|
|
10.6
|
|
Second Amendment to the St. Jude Medical, Inc. Management Savings Plan is incorporated by reference to Exhibit 10.6 to St. Jude Medical's Annual Report on Form 10-K for the year ended December 28, 2013. *
|
|
|
|
Exhibit
|
|
Exhibit Index
|
|
|
|
10.7
|
|
Third Amendment to the St. Jude Medical, Inc. Management Savings Plan is incorporated by reference to Exhibit 10.2 to St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended September 27, 2014. *
|
|
|
|
10.8
|
|
Fourth Amendment to the St. Jude Medical, Inc. Management Savings Plan is incorporated by reference to Exhibit 10.3 to St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended September 27, 2014. *
|
|
|
|
10.9
|
|
Fifth Amendment to the St. Jude Medical, Inc. Management Savings Plan. *#
|
|
|
|
10.10
|
|
St. Jude Medical, Inc. 2007 Employee Stock Purchase Plan, as amended effective August 1, 2013, is incorporated by reference to Exhibit 10.2 to St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended June 29, 2013.*
|
|
|
|
10.11
|
|
St. Jude Medical, Inc. 2002 Stock Plan, as amended and restated (2014). *#
|
|
|
|
10.12
|
|
Form of Non-Qualified Stock Option Agreement (amended 2011) and related Notice of Non-Qualified Stock Option Grant under the St. Jude Medical, Inc. 2002 Stock Plan, as amended, is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Quarterly Report on Form 10-Q for the quarter ended July 2, 2011.*
|
|
|
|
10.13
|
|
St. Jude Medical, Inc. 2006 Stock Plan, as amended and restated (2014). *#
|
|
|
|
10.14
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors (amended 2011) and related Notice of Non-Qualified Stock Option Grant for options granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.2 to St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended July 2, 2011. *
|
|
|
|
10.15
|
|
Form of Non-Qualified Stock Option Agreement for Employees (amended 2011) and the related Notice of Non-Qualified Stock Option Grant for options granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2006 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 July 2, 2011.*
|
|
|
|
10.16
|
|
Form of Non-Qualified Stock Option Agreement (amended 2011) and related Notice of Non-Qualified Stock Option Grant for options granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.4 of St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended July 2, 2011. *
|
|
|
|
10.17
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors (amended 2011) and related Notice of Non-Qualified Stock Option Grant for options granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.5 of St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended July 2, 2011. *
|
|
|
|
10.18
|
|
Form of Restricted Stock Award Agreement (amended 2011) and related Restricted Stock Award Certificate for restricted stock granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.6 to St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended July 2, 2011. *
|
|
|
|
10.19
|
|
Form of Restricted Stock Units Award Agreement (amended 2011) and related Restricted Stock Units Award Certificate for restricted stock units granted prior to December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan, is incorporated by reference to Exhibit 10.7 to St. Jude Medical's Quarterly Report on Form 10-Q for the quarter ended July 2, 2011. *
|
|
|
|
Exhibit
|
|
Exhibit Index
|
|
|
|
10.20
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors and related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.21 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.21
|
|
Form of Non-Qualified Stock Option Agreement for Employees and the related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2006 Stock Plan is incorporated by reference to Exhibit 10.22 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.22
|
|
St. Jude Medical, Inc. 2007 Stock Incentive Plan, as amended and restated (2014). *#
|
|
|
|
10.23
|
|
Form of Non-Qualified Stock Option Agreement (Global) and related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan is incorporated by reference to Exhibit 10.24 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012.*
|
|
|
|
10.24
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors and related Notice of Non-Qualified Stock Option Grant for stock options granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan is incorporated by reference to Exhibit 10.25 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.25
|
|
Form of Restricted Stock Award Agreement and related Restricted Stock Award Certificate for restricted stock granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan is incorporated by reference to Exhibit 10.26 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.26
|
|
Form of Restricted Stock Units Award Agreement (Global) and related Restricted Stock Units Award Certificate for restricted stock units granted on or after December 10, 2012 under the St. Jude Medical, Inc. 2007 Stock Incentive Plan is incorporated by reference to Exhibit 10.27 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.27
|
|
Form of Severance Agreement between St. Jude Medical, Inc. and executive officers hired prior to December 10, 2012 is incorporated by reference to Exhibit 10.1 to St. Jude Medical’s Current Report on Form 8-K filed on January 7, 2009. *
|
|
|
|
10.28
|
|
Form of Severance Agreement between St. Jude Medical, Inc. and executive officers hired on or after December 10, 2012 is incorporated by reference to Exhibit 10.35 of St. Jude Medical, Inc.'s Annual Report on Form 10-K for the year ended December 29, 2012. *
|
|
|
|
10.29
|
|
Multi-Year $1,500,000,000 Credit Agreement dated as of May 31, 2013 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 10.39 of St. Jude Medical's Annual Report on Form 10-K for the year ended December 28, 2013.
|
|
|
|
10.30
|
|
$500,000,000 Term Loan Agreement dated as of June 26, 2013 between St. Jude Medical, Inc., as the Borrower, and Bank of America, N.A., as the Lender is incorporated by reference to Exhibit 10.40 of St. Jude Medical's Annual Report on Form 10-K for the year ended December 28, 2013.
|
|
|
|
10.31
|
|
$250,000,000 Term Loan Agreement dated as of August 6, 2014 between St. Jude Medical, Inc., as the Borrower, and Bank of America, N.A., as the Lender 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, 2014.
|
|
|
|
Exhibit
|
|
Exhibit Index
|
|
|
|
12
|
|
Computation of Ratio of Earnings to Fixed Charges. #
|
|
|
|
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. #
|
|
|
|
101
|
|
Financial statements from the Annual Report on Form 10-K of St. Jude Medical, Inc. for the year ended January 3, 2015, formatted in XBRL: (i) the Consolidated Statements of Earnings, (ii) the Consolidated Statements of Comprehensive Income, (iii) the Consolidated Balance Sheets, (iv) the Consolidated Statements of Shareholders’ Equity, (v) the Consolidated Statements of Cash Flows and (vi) the Notes to the Consolidated Financial Statements.
|
|
|
|
*
|
Management contract or compensatory plan or arrangement.
|
|
#
|
Filed as an exhibit to this Annual Report on Form 10-K.
|
(b)
|
Exhibits
: Reference is made to Item 15(a)(3).
|
(c)
|
Schedules
:
|
|
|
Balance
|
|
Additions
|
|
Deductions
|
|
|
||||||||||||||||
Description
|
|
at Beginning
of Year
|
|
Charged to
Expense
|
|
Other (2)
|
|
Write-offs (1)
|
|
Other (2)
|
|
Balance at
End of Year
|
||||||||||||
Allowance for doubtful accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Fiscal year ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
January 3, 2015
|
|
$
|
45
|
|
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
(6
|
)
|
|
$
|
—
|
|
|
$
|
53
|
|
December 28, 2013
|
|
$
|
47
|
|
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
(16
|
)
|
|
$
|
—
|
|
|
$
|
45
|
|
December 29, 2012
|
|
$
|
101
|
|
|
$
|
6
|
|
|
$
|
1
|
|
|
$
|
(61
|
)
|
|
$
|
—
|
|
|
$
|
47
|
|
Description
|
|
Balance at Beginning of Year
|
|
Additions
|
|
Deductions
|
|
Other (3)
|
|
Balance at
End of Year
|
||||||||||
Valuation allowance - Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Fiscal year ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
January 3, 2015
|
|
$
|
368
|
|
|
$
|
44
|
|
|
$
|
(13
|
)
|
|
$
|
1
|
|
|
$
|
400
|
|
December 28, 2013
|
|
$
|
228
|
|
|
$
|
140
|
|
|
$
|
(7
|
)
|
|
$
|
7
|
|
|
$
|
368
|
|
December 29, 2012
|
|
$
|
157
|
|
|
$
|
76
|
|
|
$
|
(5
|
)
|
|
$
|
—
|
|
|
$
|
228
|
|
(1)
|
Uncollectible accounts written off, net of recoveries. During 2012, the Company wrote-off
$55 million
related to its Greek distributor, previously reserved for during the fiscal year ended December 31, 2011.
|
(2)
|
Primarily represents the effects of changes in foreign currency translation.
|
(3)
|
Primarily represents the effects of changes in foreign currency translation and tax adjustments for changes in statutory tax rates.
|
|
|
|
|
|
|
ST. JUDE MEDICAL, INC.
|
|
|
|
|
|
Date:
|
February 26, 2015
|
By:
|
/s/ DANIEL J. STARKS
|
|
|
|
Daniel J. Starks
|
|
|
|
Chairman, President and Chief Executive Officer
|
|
|
|
/s/ DANIEL J. STARKS
|
|
Chairman of the Board, President and Chief Executive Officer
|
Daniel J. Starks
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/ DONALD J. ZURBAY
|
|
Vice President, Finance and Chief Financial Officer
|
Donald J. Zurbay
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
*
|
|
Director
|
John W. Brown
|
|
|
|
|
|
*
|
|
Director
|
Richard R. Devenuti
|
|
|
|
|
|
*
|
|
Director
|
Stuart M. Essig
|
|
|
|
|
|
*
|
|
Director
|
Barbara B. Hill
|
|
|
|
|
|
*
|
|
Director
|
Michael A. Rocca
|
|
|
|
|
|
*
|
|
Director
|
Stefan K. Widensohler
|
|
|
|
|
|
*
|
|
Director
|
Wendy L. Yarno
|
|
|
|
|
|
* By: /s/ JASON A. ZELLERS
|
|
|
Jason A. Zellers
|
|
|
Attorney-in-Fact
|
|
|
1.
|
The definition of “Eligible Compensation” in Article 1 of the Plan is amended to delete the exclusions in items (1) and (2) and to renumber the remaining exclusion items accordingly.
|
2.
|
Article 1 of the Plan is amended, effective as of December 1, 2014, to add alphabetically the following new definitions:
|
(1)
|
“
Employment Commencement Date
” means the date upon which a Participant first performs one hour of service as an employee for the Company or an Affiliate.
|
(2)
|
“
Period of Service
” means the measure of a Participant’s employment with the Company and any Affiliate which is equal to the period commencing on the Participant’s Employment Commencement Date or Reemployment Commencement Date, as appropriate and ending on the Participant’s next following Severance Date and stated in years and months and days where 30 days equals one month and 365 days equals one year; provided, however:
|
(1)
|
unless some or all of a Participant’s service may be disregarded pursuant to other rules of this Plan, all discontinuous Periods of Service shall be aggregated in determining the total of a Participant’s Period of Service;
|
(2)
|
if a Participant quits, is discharged or retires from service with the Company and all Affiliates and performs an hour of service as an Employee within the 12 months following the Severance Date, that Period of Severance shall be deemed to be a Period of Service; and
|
(3)
|
if a Participant severs from service with the Company and all Affiliates by reason of a quit, a discharge or retirement during the first 12 months of an absence from service for any reason other than a quit, a discharge, retirement or death and then performs an hour of service within the 12 months following the date on which the Participant
|
(3)
|
“
Period of Severance
” means the period of time commencing on a Participant’s Severance Date and ending on the date on which that Participant next again performs an hour of service as an employee for the Company or an Affiliate. A Period of Severance shall be stated in years and months and days, where 30 days equals one month and 365 days equals one year.
|
(4)
|
“
Reemployment Commencement Date
” means the date upon which a Participant first performs an hour of service as an employee for the Company or an Affiliate following a Period of Severance that is not deemed to be a Period of Service.
|
(5)
|
“
Severance Date
” means the earlier of:
|
(1)
|
the date upon which a Participant ceases to perform any services as an employee for the Company and all Affiliates as a result of a quit, discharge, retirement or death; or
|
(2)
|
the date which is the first anniversary of the first day of a period in which a Participant remains continuously absent from service (with or without pay) with the Company and all Affiliates for any reason other than a quit, a discharge, retirement or death, such as vacation, holiday, sickness, Disability, leave of absence or layoff.
|
3.
|
Effective as of November 1, 2014, the definition of Year of Service in Article 1 and all references in the Plan to Year of Service are deleted and replaced with “Year of Vesting Service,” which shall be defined as follows:
|
4.
|
Section 5.1 of the Plan is amended to replace the second sentence to read as follows:
|
5.
|
Section 5.2(d)(2) and (3) of the Plan are amended to read as follows:
|
“(2)
|
the portion of the amounts credited to an Account or Accounts of a Participant during any day were invested in the Measurement Fund(s) selected by the Participant, in the percentages applicable to such day, as soon as administratively feasible following the day on which such amounts were actually deferred or credited to the Account or Accounts of the Participant at the closing price on such date; and
|
(3)
|
any distribution made to a Participant that decreases the Account or Accounts of the Participant ceases being an investment in the Measurement Fund(s), in the percentages applicable to such day, no later than seven business days prior to the distribution, at the closing price on such date.”
|
6.
|
Section 7.2(a) of the Plan is amended to replace the fifth sentence with the following:
|
7.
|
Section 7.2(e) of the Plan is amended to add a new sentence at the end thereof to read:
|
8.
|
Section 7.2(f) of the Plan is amended in its entirety to read as follows:
|
(f)
|
“Notwithstanding anything to the contrary in the Plan or in a Participant payment election, a distribution under Section 7.1(a) and Section 7.7 to a Participant who, on the date of Separation from Service is a Specified Employee, shall be made or begin in the first calendar quarter that begins six months after the Participant’s Separation from Service (or, if earlier, the Specified Employee’s death). This limitation applies regardless of the Participant’s status as a Specified Employee on any other date including the next Specified Employee effective date had the Participant continued to render services through such date. The Participant’s Accounts shall continue to be adjusted as provided in Section 5.2.”
|
9.
|
Except as set forth in this Instrument, the Plan, as restated and amended, shall remain in full force and effect.
|
|
|
|
ST. JUDE MEDICAL, INC.
|
|
|
|
|
|
|
Date
|
December 5, 2014
|
|
By
|
/s/ Angela Craig
|
|
|
|
Its
|
VP, Global Human Resources
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ST. JUDE MEDICAL, INC.
2002 STOCK PLAN
AS AMENDED AND RESTATED (2014)
|
(i).
|
cause the Plan to no longer comply with Rule 16b-3, Section 422 of the Code or any other regulatory requirements;
|
(ii).
|
materially increase the benefits accruing to participants under this plan;
|
(iii).
|
materially increase the aggregate number of securities that may be issued under this Plan except pursuant to the second paragraph of Section 3 which permits adjustments in the number of shares of stock in certain events such as a stock split or dividend in a manner that is “appropriate in order to prevent dilution or enlargement of the benefits or potential benefits intended to be made available under the Plan...”;
|
(iv).
|
materially modify the requirements as to eligibility for participation in this plan unless the amendment or alteration shall be subject to shareholder approval; or
|
(v).
|
reduce the minimum vesting requirements for Stock Options contrary to the provisions of Section 5(d) hereof.
|
ST. JUDE MEDICAL, INC.
2006 STOCK PLAN
AS AMENDED AND RESTATED (2014)
|
ST. JUDE MEDICAL, INC.
2007 STOCK INCENTIVE PLAN
AS AMENDED AND RESTATED (2014)
|
|
|
TABLE OF CONTENTS
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
Section 1.
|
|
Purpose
|
1
|
|
Section 2.
|
|
Definitions
|
1
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|
Section 3.
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|
Administration
|
4
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(a)
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Power and Authority of the Committee
|
4
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|
(b)
|
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Delegation
|
4
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(c)
|
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Power and Authority of the Board of Directors
|
5
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Section 4.
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Shares Available for Awards
|
5
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(a)
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Shares Available
|
5
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(b)
|
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Accounting for Awards
|
5
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(c)
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Adjustments
|
5
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(d)
|
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Award Limitations Under the Plan
|
6
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Section 5.
|
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Eligibility
|
6
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Section 6.
|
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Awards
|
7
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(a)
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Options
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7
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(b)
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Stock Appreciation Rights
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7
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(c)
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Restricted Stock and Restricted Stock Units
|
8
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(d)
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Dividend Equivalents
|
9
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(e)
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|
Performance Awards
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9
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(f)
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Stock Awards
|
9
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(g)
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Other Stock-Based Awards
|
9
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(h)
|
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General
|
10
|
|
Section 7.
|
|
Amendment and Termination; Corrections
|
11
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|
(a)
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|
Amendments to the Plan
|
11
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(b)
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|
Amendments to Awards
|
12
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(c)
|
|
Correction of Defects, Omissions and Inconsistencies
|
12
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|
Section 8.
|
|
Income Tax Withholding
|
12
|
|
Section 9.
|
|
General Provisions
|
12
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|
(a)
|
|
No Rights to Awards
|
12
|
|
(b)
|
|
Award Agreements
|
12
|
|
(c)
|
|
No Rights of Shareholders
|
13
|
|
(d)
|
|
No Limit on Other Compensation Plans or Arrangements
|
13
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(e)
|
|
No Right to Employment or Directorship
|
13
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(f)
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|
Governing Law
|
13
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(g)
|
|
Severability
|
13
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(h)
|
|
No Trust or Fund Created
|
13
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|
(i)
|
|
Securities Matters
|
13
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|
(j)
|
|
No Fractional Shares
|
13
|
|
(k)
|
|
Headings
|
13
|
|
Section 10.
|
|
Effective Date of the Plan
|
14
|
|
Section 11.
|
|
Term of the Plan
|
14
|
|
Section 1.
|
Purpose.
|
Section 2.
|
Definitions.
|
Section 3.
|
Administration
.
|
Section 4.
|
Shares Available for Awards
.
|
Section 5.
|
Eligibility
.
|
Section 6.
|
Awards
.
|
Section 8.
|
Income Tax Withholding
.
|
Section 9.
|
General Provisions
.
|
Section 10.
|
Effective Date of the Plan
.
|
Section 11.
|
Term of the Plan
.
|
|
|
FISCAL YEAR
|
||||||||||||||||||
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Earnings before noncontrolling interest and income taxes
|
|
$
|
1,068
|
|
|
$
|
784
|
|
|
$
|
1,005
|
|
|
$
|
1,019
|
|
|
$
|
1,208
|
|
Plus fixed charges:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Interest expense (1)
|
|
85
|
|
|
81
|
|
|
73
|
|
|
70
|
|
|
67
|
|
|||||
Rent interest factor (2)
|
|
17
|
|
|
12
|
|
|
15
|
|
|
15
|
|
|
12
|
|
|||||
TOTAL FIXED CHARGES
|
|
102
|
|
|
93
|
|
|
88
|
|
|
85
|
|
|
79
|
|
|||||
EARNINGS BEFORE NONCONTROLLING INTEREST, INCOME TAXES AND FIXED CHARGES
|
|
$
|
1,170
|
|
|
$
|
877
|
|
|
$
|
1,093
|
|
|
$
|
1,104
|
|
|
$
|
1,287
|
|
RATIO OF EARNINGS TO FIXED CHARGES
|
|
11.5
|
|
|
9.4
|
|
|
12.4
|
|
|
13.0
|
|
|
16.3
|
|
(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.
|
•
|
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)
|
•
|
St. Jude Medical Europe, Inc. - St. Paul, Minnesota (Delaware corporation)
|
•
|
St. Jude Medical Canada, Inc. - Mississauga, Ontario (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) (64.42% (1,381,000 shares) held by St. Jude Medical, Inc. and 27.21% (583,251 shares) held by St. Jude Medical Asia Pacific Holdings GK) and 8.37% (179,373 shares) held by St. Jude Medical Luxembourg S. a r.l
|
•
|
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)
|
•
|
St. Jude Medical Colombia, Ltda. - Bogota, Colombia (Colombian corporation)
|
•
|
CardioMEMS, LLC.. - (Delaware limited liability company) (merged with Eagle merger corp)
|
•
|
St. Jude Medical ATG, Inc. - Maple Grove, Minnesota (Minnesota corporation) (Shell)
|
•
|
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)
|
◦
|
LightLab Imaging, Inc. - Westford, Massachusetts (Delaware corporation)
|
◦
|
Sealing Solutions, Inc. - Plymouth, Minnesota (Georgia corporation)
|
•
|
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)
|
•
|
AGA Medical Holdings, Inc. - Plymouth, Minnesota (Delaware corporation)
|
◦
|
AGA Medical Corporation - Plymouth, Minnesota (Minnesota corporation)
|
▪
|
AGA Medical Belgium SPRL (Belgian corporation)
|
◦
|
NeuroTherm LLC (Delaware limited liability company)
|
▪
|
Flivopress BV (Dutch corporation) (Wholly owned subsidiary of NeuroTherm LLC)
|
▪
|
RDG Medical Holdings, Ltd. (UK corporation) (Wholly owned subsidiary of NeuroTherm LLC)
|
•
|
SJM International, Inc. - St. Paul, Minnesota (Delaware corporation)
|
◦
|
St. Jude Medical Mexico Business Services, S.de R.L. de C.V. (Mexico Corporation)
|
◦
|
St. Jude Medical International Holding S.a r.l. (Luxembourg corporation)
|
◦
|
U.S. Branch of St. Jude Medical International Holding S.à r.l.
|
◦
|
St. Jude Medical Luxembourg Holding II S.à r.l. (Luxembourg Corporation)
|
◦
|
St. Jude Medical Luxembourg Holding NT S.à r.l. (Luxembourg Corporation)
|
◦
|
St. Jude Medical Sweden AB (Swedish corporation)
|
◦
|
St. Jude Medical Danmark A/S (Danish corporation)
|
◦
|
St. Jude Medical (Portugal) - DistribuiMed de Produtos MModuto, 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 Espana 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)
|
▪
|
St. Jude Medical Luxembourg Holding S.a.r.l. (Luxembourg Corporation)U.S. Branch of St. Jude Medical Luxembourg Holding S.à r.l.
|
◦
|
MediGuide, LLC (Delaware limited liability company)
|
▪
|
MediGuide Ltd. (Israeli corporation)
|
▪
|
St. Jude Medical Nederland B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)
|
◦
|
NeuroTherm BV (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Nederland B.V.)
|
▪
|
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 GVA S.a r. l. (Switzerland corporation) (formerly Endosense S.A.)
|
▪
|
SJM Coordination Center BVBA (Belgian corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg Holding S.à r.l.)
|
◦
|
Cardio Life Research S.A. (Belgian corporation)
|
◦
|
St. Jude Medical Balkan d.o.o. (Serbian corporation)
|
◦
|
St. Jude Medical Estonia OÜ (Estonian corporation)
|
◦
|
SJM Hellas Limited Liability Trading Company (Greece corporation)
|
◦
|
Beirut Lebanon Branch
|
▪
|
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 Luxembourg S.a r.l. (Luxembourg corporation)
|
◦
|
US Branch of St. Jude Medical Luxembourg S.a.r.l.
|
◦
|
St. Jude Medical Holdings B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Luxembourg S.à r.l.)
|
▪
|
St. Jude Medical India Private Limited (Indian corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)
|
▪
|
St. Jude Medical New Zealand Limited (New Zealand corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)
|
▪
|
St. Jude Medical Asia Pacific Holdings GK (Japanese corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.)
|
◦
|
St. Jude Medical Japan Co., Ltd. (Japanese corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical (Singapore) Pte. Ltd. (Singaporean corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical (Malaysia) Sdn Bhd (Malaysian corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical Taiwan Co. (Taiwan corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical Korea YH (Korean corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical (Hong Kong) Limited (Hong Kong corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
◦
|
St. Jude Medical (Thailand) Co., Ltd. - Bangkok, Thailand (Thai corporation) (wholly owned subsidiary of St. Jude Medical Asia Pacific Holdings GK)
|
▪
|
St. Jude Medical AB (Swedish corporation) (Wholly owned subsidiary of St. Jude Medical Holdings BV)
|
◦
|
St. Jude Medical Systems AB (formerly Radi Medical Systems AB) (Swedish corporation)
|
▪
|
Radi Medical Systems Pte., Ltd. (Singapore corporation)
|
◦
|
HB Betakonsult (Swedish partnership) (St. Jude Medical AB holds a 99% interest and St. Jude Medical Systems AB holds a 1% interest)
|
|
|
|
/s/ DANIEL J. STARKS
|
|
/s/ BARBARA B. HILL
|
Daniel J. Starks
|
|
Barbara B. Hill
|
Chairman, President and Chief Executive Officer
|
|
Director
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ DONALD J. ZURBAY
|
|
/s/ MICHAEL A. ROCCA
|
Donald J. Zurbay
|
|
Michael A. Rocca
|
Vice President, Finance 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
|
|
|
|
|
|
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 26, 2015
|
|
|
|
/s/ DANIEL J. STARKS
|
|
Daniel J. Starks
|
|
Chairman, President and Chief Executive Officer
|
|
|
|
|
I, Donald J. Zurbay, 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 26, 2015
|
|
|
|
/s/ DONALD J. ZURBAY
|
|
Donald J. Zurbay
|
|
Vice President, Finance and Chief Financial Officer
|
|
|
|
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 26, 2015
|
|
|
|
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/ DONALD J. ZURBAY
|
|
|
Donald J. Zurbay
|
|
|
Vice President, Finance and
|
|
|
Chief Financial Officer
|
|
|
February 26, 2015
|
|