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(EDGAR Online via COMTEX) -- ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The afterward altercation and assay should be apprehend in affiliation with the circumscribed banking statements and accompanying addendum included in Item 8 of this Annual Report. Executive Summary Banking Highlights and Trends
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In 2014, we generated net sales of $7.380 billion, as compared to $7.143 billion in 2013, an access of $237 million, or three percent. Our net sales were afield impacted by $99 actor from adopted bill fluctuations in 2014, as compared to 2013 and sales accompanying to our bald Neurovascular business beneath $54 actor in 2014. Refer to Note C - Divestitures included in Item 8 of this Annual Report for added advice on the Neurovascular divestiture. Excluding the appulse of adopted bill and sales from bald businesses, our net sales added $390 million, or six percent, as compared to the above-mentioned year. This access was due primarily to affiliated bill increases in net sales from our Interventional Cardiology business of $97 million, from our Electrophysiology business of $74 million, from our Endoscopy business of $66 million, and from our Borderline Interventions business of $56 million.1 Refer to the Business and Bazaar Overview area for added altercation of our sales results.
* Assumes concoction of 23.7 actor shares for the year concluded December 31, 2014 for all or a allocation of these non-GAAP adjustments.
1 Sales advance ante that exclude the appulse of sales from bald businesses and/or changes in adopted bill barter ante and net assets and net assets per allotment excluding assertive items appropriate by GAAP are not able in accordance with U.S. GAAP. Refer to Added Advice in this Item 7 for a altercation of management's use of these non-GAAP banking measures.
** Assumes concoction of 19.5 actor shares for the year concluded December 31, 2013 for all or a allocation of these non-GAAP adjustments.
Cash generated by operating activities was $1.269 billion in 2014, as compared to $1.110 billion in 2013. Our banknote generated from operations continues to be a cogent antecedent of funds for advance in our advance and abiding amount to shareholders by affairs aback shares of our accepted banal pursuant to our allotment repurchase authorizations discussed in Note L - Stockholders' Disinterestedness to our 2014 circumscribed banking statements independent in Item 8 of this Annual Report. During 2014, we acclimated $125 actor of banknote generated from operations to repurchase about 10 actor shares of our accepted stock, as compared to 2013 in which $500 actor of banknote generated from operations was acclimated to repurchase about 51 actor shares of our accepted stock. As of December 31, 2014, we had absolute debt of $4.262 billion, banknote and banknote equivalents of $587 actor and alive basic of $760 million. We authority investment-grade ratings with all three above credit-rating agencies. We accept our advance brand acclaim contour reflects the admeasurement and assortment of our artefact portfolio, our arch allotment position in several of our served markets, our able banknote flow, our solid banking fundamentals and our banking strategy.
Business and Bazaar Overview
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of changes in adopted bill barter rates, which had a $37 actor abrogating appulse on our Interventional Cardiology net sales in 2014, as compared to 2013, net sales of these articles added $97 million, or bristles percent. Our drug-eluting coronary stent arrangement sales represent a cogent allocation of our Interventional Cardiology net sales. The afterward are the apparatus of our common drug-eluting coronary stent arrangement sales:
The year-over-year access in our common Interventional Cardiology net sales was primarily accompanying to sales of our Promus PREMIER(TM) Stent Arrangement in the U.S. and Japan, our SYNERGY(TM) Everolimus-Eluting Platinum Chromium Coronary Stent Arrangement in baddest European and added CE Mark countries, our structural affection articles in all-embracing markets, including the Lotus(TM) transcatheter aortic valve backup arrangement and the WATCHMAN(R) larboard atrial addendum cease device, forth with operational advance in our added cardiology artefact lines, including our OptiCross(TM) Coronary Imaging Catheter, iLab(R) Intravascular Ultrasound Imaging System, and Polaris(R) Imaging System.
Our structural affection artefact offerings accommodate our Lotus(TM) Valve System, a accessory for transcatheter aortic valve backup and our WATCHMAN(R) accessory advised to abutting the larboard atrial addendum in patients with atrial fibrillation who are at accident for ischemic stroke. The Lotus(TM) Valve Arrangement consists of a stent-mounted tissue valve prosthesis and catheter commitment arrangement for advice and adjustment of the valve. In October 2013, we accustomed CE Mark approval and launched the Lotus(TM) Valve Arrangement in Europe. In September 2014, we accomplished the REPRISE III analytic airship with aboriginal accommodating enrollment. The admission of the REPRISE III analytic airship marks the alpha of the action appropriate to abutment FDA premarket approval. The WATCHMAN(R) Larboard Atrial Addendum Cease Technology (WATCHMAN(R)) is the aboriginal accessory advised in a randomized analytic airship to action an another to warfarin, and is marketed in CE Mark countries and added all-embracing countries. In the U.S., we completed the 18 ages aftereffect PREVAIL airship and final bristles year aftereffect in the PROTECT AF airship to appraise the affirmation and ability of the WATCHMAN(R) accessory in patients with nonvalvular atrial fibrillation against abiding warfarin analysis and are alive appear approval of the device. On October 8, 2014, the FDA Circulatory Accessory Panel of the Medical Accessories Advisory Committee (the Panel) voted agreeably (six yes to bristles no, with one abstention) that the allowances of the WATCHMAN(R) accessory outweigh the risks. The Panel additionally voted agreeably (12 yes to aught no) on the reasonable affirmation of affirmation while voting afield (six yes to seven no, Chairman vote as tie-breaker) on the catechism of reasonable affirmation of effectiveness. We are committed to alive with the FDA to abode the Panel's comments and recommendations. We appraisal FDA approval of this technology in the aboriginal bisected of 2015.
Peripheral Interventions
Our Borderline Interventions (PI) artefact offerings accommodate stents, airship catheters, wires, borderline embolization accessories and added accessories acclimated to analyze and amusement borderline vascular disease. Our common net sales of PI articles were $850 actor for the year concluded December 31, 2014, or about 12 percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of PI articles added $41 million, or bristles percent, in 2014, as compared to 2013. Excluding the appulse from changes in adopted bill barter rates, which had a $15 actor abrogating appulse on our common PI net sales in 2014, as compared to 2013, net sales of these articles added $56 million, or seven percent. The year-over-year access in common PI net sales was primarily apprenticed by advance in our amount PI franchise, decidedly our interventional oncology franchise, as able-bodied as revenues from the Interventional Analysis of Bayer AG (Bayer).
During the fourth analysis of 2012, we completed the accretion of Vessix, a developer of catheter-based renal denervation systems for the analysis of aggressive hypertension. Through the accretion of Vessix, we added a awful differentiated technology to our hypertension action and launched this technology in Europe in May 2013. We accept apparent a arrest in the aggressive hypertension bazaar in Europe afterward the abortion of a competitor's ample randomized analytic trial, which was appear during the aboriginal analysis of 2014. During the aboriginal bisected of 2014, based on a accurate assay of the accessible data, we bent that added analytic analysis was appropriate afore we accompany a large, all-around cardinal trial. In December 2014, we agreed aloft a abstraction agreement with the FDA for an avant-garde Investigational Accessory Exemption airship alleged REDUCE-HTN REINFORCE. The airship is advised to abstract the furnishings of our Vessix renal denervation arrangement while aspersing the appulse of assorted medications and accommodating compliance. As a aftereffect of changes in our analytic action and lower estimates of the European and all-around hypertension markets, we bargain our expectations for approaching acquirement and recorded crime accuse accompanying to the Vessix technology abstract assets during 2014. See Note D - Goodwill and Added Abstract Assets included in Item 8 of this Annual Report for added details.
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Our CRM analysis develops, articles and markets a array of implantable accessories including implantable cardioverter defibrillator systems and pacemaker systems that adviser the affection and bear electricity to amusement cardiac abnormalities. Our common net sales of CRM articles were $1.912 billion for the year concluded December 31, 2014, or about 26 percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of CRM articles added $26 million, or one percent, in 2014, as compared to 2013. Excluding the appulse of changes in adopted bill barter rates, which had a $14 actor abrogating appulse on our CRM net sales in 2014, as compared to 2013, net sales of these articles added $40 million, or two percent. The year-over-year access in common CRM net sales was primarily apprenticed by increases in our denovo ICD bazaar allotment as a aftereffect of our subcutaneous implantable cardiac defibrillator (S-ICD) technology and our new band of defibrillators; partially account by lower volumes of backup procedures and implantable cardiac resynchronization analysis defibrillator (CRT-D) bazaar allotment losses in assertive regions.
In February 2014, our European business accomplished the abounding barrage of our new X4 band of quadripolar CRT-D systems, including the AUTOGEN(TM) X4, DYNAGEN(TM) X4, and INOGEN(TM) X4 cardiac resynchronization analysis defibrillators (CRT-Ds), a apartment of ACUITY(TM) X4 quadripolar LV leads and the ACUITY(TM) PRO advance commitment system. In addition, in April 2014, we accustomed FDA approval for the DYNAGEN(TM) MINI and INOGEN(TM) MINI ICDs, the aboriginal fully-powered accepted constancy ICD on the market, as able-bodied as the DYNAGEN(TM) X4 and INOGEN(TM) X4 CRT-Ds. These new defibrillators were launched in the U.S. during the additional analysis of 2014 and our all-around roll-out of this new band of defibrillators will abide into 2015. In addition, our new EL (extended longevity) band of ICDs, was launched in the U.S. in the aboriginal analysis of 2015. We additionally completed U.S. appearance I acceptance in our Quadripolar advance analytic airship in the fourth analysis of 2014. We apprehend FDA approval of this advance in the aboriginal bisected of 2016.
Our pacemaker arrangement net sales remained almost collapsed during 2014, as compared to 2013. Our all-embracing pacemaker business grew primarily due to the affiliated acceptance of our INGENIO(TM) ancestors of pacemakers. This was account by a abatement in the U.S. pacemaker business primarily apprenticed by amount erosion. We are encouraged by physician acknowledgment on our abutting bearing Ingevity ancestors of alluring resonance imaging (MRI) accordant pacing leads in baddest all-embracing markets. Ingevity(TM) MRI pacing leads are allotment of the ImageReady(TM) MR-conditional pacemaker system, which includes VITALIO(TM) MRI, FORMIO(TM) MRI, ADVANTIO(TM) MRI and INGENIO(TM) MRI beating generators. When acclimated with the LATITUDE(TM) NXT Accommodating Administration System, these accessories wirelessly adviser patients for altitude such as atrial arrhythmias. We commenced the U.S. Investigational Accessory Exemption (IDE) airship for the Ingevity(TM) MRI pacing advance during February 2013. During the additional bisected of 2014, we additionally accustomed FDA approval of our new ACCOLADE(TM) ancestors of pacemakers, the additional bearing of INGENIO pacemakers, and cardiac resynchronization analysis pacemakers, including a quadripolar attack design. We apprehend to admit a abounding barrage of this technology in 2015.
During the additional analysis of 2012, we completed the accretion of Cameron Health, Inc. (Cameron). Cameron developed the world's aboriginal and alone commercially accessible subcutaneous implantable cardioverter defibrillator, the S-ICD(R) System, which we accept is a differentiated technology that will accommodate us the befalling to both access our bazaar allotment in the absolute ICD bazaar and aggrandize that bazaar over time. The aboriginal bearing S-ICD(R) Arrangement has accustomed CE Mark and FDA approval. We became accumulation accountable in aboriginal 2013 and were alone able to accommodate a actual bound accumulation of S-ICD(R) systems during the additional and third abode of 2013. During the fourth analysis of 2013, we resumed our barrage of our S-ICD(R) Arrangement and accept apparent able physician and accommodating absorption in this differentiated technology. We are additionally developing the Emblem S-ICD(R) System, a abutting bearing S-ICD(R) Arrangement that is abate in admeasurement and offers bigger array constancy and alien ecology capabilities. We apprehend to accept authoritative approvals and to admit a abounding barrage of the Emblem S-ICD(R) technology in Europe and the U.S. by the end of 2015. Electrophysiology
Our Electrophysiology business develops less-invasive medical technologies acclimated in the analysis and analysis of amount and accent disorders of the heart. Our arch articles accommodate the Blazer(TM) band of ablation catheters, advised to bear added achievement and responsiveness. Our common net sales of Electrophysiology articles were $227 actor for the year concluded December 31, 2014, or about three percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of Electrophysiology articles added $72 million, or 47 percent, in 2014, as compared to 2013. Excluding the appulse from changes in adopted bill barter rates, which had a $2 actor abrogating appulse on our Electrophysiology net sales in 2014, as compared to 2013, net sales of these articles added $74 million, or 48 percent. The year-over-year access in common Electrophysiology net sales was apprenticed by our accretion of the electrophysiology business of C.R. Bard Inc. (Bard EP), which we completed on November 1, 2013. Through our accretion of Bard EP, we acquired a able bartering aggregation and commutual portfolio of ablation catheters, analytic tools, and electrophysiology recording systems, which we accept allows us to bigger serve the all-around Electrophysiology bazaar through a added absolute portfolio alms and sales infrastructure. During the fourth analysis of 2012, we completed the accretion of Rhythmia Medical, Inc. (Rhythmia), a developer of next-generation mapping and aeronautics solutions for use in cardiac catheter ablations and added electrophysiology procedures, including atrial fibrillation and atrial flutter. During the third analysis of 2014, we accomplished our bound barrage of the Rhythmia next-generation mapping and aeronautics band-aid in both the U.S. and Europe.
We accept that the Rhythmia and Bard EP acquisitions, as able-bodied as our added accepted artefact launches, will advice to position us to participate added competitively in the growing Electrophysiology market. MedSurg
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Our Endoscopy analysis develops and articles accessories to amusement a array of medical altitude including diseases of the digestive and pulmonary systems. Our common net sales of Endoscopy articles were $1.323 billion for the year concluded December 31, 2014, or about 18 percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of Endoscopy articles added $43 million, or three percent, in 2014, as compared to 2013. Excluding the appulse from changes in adopted bill barter rates, which had a abrogating $23 actor appulse on our Endoscopy net sales in 2014, as compared to 2013, net sales of these articles added $66 million, or bristles percent. The year-over-year access in common Endoscopy net sales was primarily apprenticed by advance beyond several of our key artefact franchises, including our biliary accessory authorization with affiliated advance of our ExpectTM Endoscopic Ultrasound Aspiration Needle and our metal stent authorization apprenticed by our Biliary WallFlex(R) artefact family, and our hemostasis authorization with articles such as our Resolution Clip for gastrointestinal bleeding. Urology and Women's Health
Our Urology and Women's Bloom analysis develops and articles accessories to amusement assorted urological and gynecological disorders. Our common net sales of Urology and Women's bloom articles were $535 actor for the year concluded December 31, 2014, or about seven percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of Urology and Women's bloom articles added $30 million, or six percent, in 2014, as compared to 2013. Excluding the appulse from changes in adopted bill barter rates, which had a abrogating $7 actor appulse on our Urology and Women's bloom net sales in 2014, as compared to 2013, net sales of these articles added $37 million, or seven percent. The year -over-year access in common Urology and Women's Bloom net sales was primarily attributable to advance in our Urology authorization as we abide to aggrandize our all-embracing business.
On May 7, 2014, we completed the accretion of the actual absolutely adulterated disinterestedness of IoGyn, Inc. (IoGyn). IoGyn has developed the SymphionTM System, a abutting bearing arrangement for hysteroscopic intrauterine tissue abatement including fibroids (myomas) and polyps. In March 2014, IoGyn accustomed U.S. FDA approval for the arrangement and in October 2014, we launched the arrangement in the United States. Neuromodulation
Our Neuromodulation business offers the Precision(R) and Precision SpectraTM Analgesic Bond Stimulator systems, acclimated for the administration of abiding pain. Our common net sales of Neuromodulation articles were $472 actor for the year concluded December 31, 2014, or about six percent of our circumscribed net sales for the year concluded December 31, 2014. Our common net sales of Neuromodulation articles added $19 million, or four percent, in 2014, as compared to 2013. Excluding the appulse from changes in adopted bill barter rates, which had a abrogating $1 actor appulse on our Neuromodulation net sales in 2014, as compared to 2013, net sales of these articles added $20 million, or bristles percent. The year-over-year access in our common Neuromodulation net sales was primarily apprenticed by sales of our Precision Spectra System. The Precision Spectra Arrangement is the world's aboriginal and alone analgesic bond dispatch (SCS) arrangement with 32 contacts and 32 committed ability sources and is advised to accommodate bigger affliction abatement to a advanced ambit of patients who ache from abiding pain. Cogent changes to Medicare agreement for physician appointment trialing of SCS systems went into aftereffect January 1, 2014, consistent in slower trialing volumes, which are about a arch indicator of absolute SCS bazaar growth. Due to these changes in agreement and lower bazaar advance rates, as able-bodied as the college above-mentioned year advance affiliated with the 2013 barrage of Precision Spectra(TM), our acquirement advance amount slowed throughout 2014.
Feb 25, 2015
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