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(EDGAR Online via COMTEX) -- ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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Introduction
Boston Scientific Corporation is a common developer, architect and banker of medical accessories that are acclimated in a ample ambit of interventional medical specialties. Our mission is to transform lives through avant-garde medical solutions that beforehand the bloom of patients about the world. Our articles and technologies are acclimated to analyze or amusement a advanced ambit of medical conditions, including heart, vascular, digestive, pulmonary, urological, pelvic health, and abiding affliction conditions. We abide to innovate in these areas and are absorbed on extending our innovations into new geographies and high-growth adjacency markets.
Financial Summary
Three Months Concluded March 31, 2016
Our net sales for the aboriginal division of 2016 were $1.964 billion, as compared to net sales of $1.768 billion for the aboriginal division of 2015, an access of $196 million, or 11 percent. Our adapted net sales, which excludes a abrogating appulse of $58 actor in the aboriginal division 2016 due to changes in adopted bill barter rates, added $254 million, or 13 percent, as compared to the aforementioned aeon in the above-mentioned year.1 This access included adapted net sales of about $98 actor in the aboriginal division 2016, with no above-mentioned year aeon accompanying net sales, due to the accretion of the AMS Portfolio Acquisition, which included the men's bloom and prostate bloom businesses, from Endo All-embracing plc, during the third division of 2015. Refer to Quarterly After-effects and Business Overview for a altercation of our net sales by all-around business.
Our appear net assets for the aboriginal division of 2016 was $202 million, or $0.15 per share. Our appear after-effects for the aboriginal division of 2016 included acquisition- and divestiture-related net charges, restructuring and restructuring-related net charges, litigation-related net accuse and acquittal amount accretion $176 actor (after-tax), or $0.13 per share. Adapted net income, which excludes these items, for the aboriginal division of 2016 was $378 million, or $0.28 per share.1 Our appear net accident for the aboriginal division of 2015 was $1 million, or $(0.00) per share. Our appear after-effects for the aboriginal division of 2015 included acquisition- and divestiture-related net charges, restructuring and restructuring-related net charges, litigation-related net charges, alimony abortion accuse and acquittal amount accretion $287 actor (after-tax), or $0.21 per share. Adapted net income, which excludes these items, for the aboriginal division of 2015 was $286 million, or $0.21 per share.1
1 Adapted net sales beforehand rates, which exclude the appulse of changes in adopted bill barter rates, and adapted net assets and adapted net assets per share, which exclude assertive items appropriate by GAAP, are not able in accordance with U.S. GAAP. Refer to Added Information for a altercation of management's use of these non-GAAP banking measures.
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The afterward is a adaptation of our after-effects of operations able in accordance with U.S. GAAP to those adapted after-effects advised by management. Refer to Quarterly After-effects and Business Overview for a altercation of anniversary reconciling item:
*Assumes concoction of 24.0 actor shares for the three months concluded March 31, 2015 for all or a allocation of these non-GAAP adjustments.
Cash provided by operating activities was $116 actor in the aboriginal division of 2016, as compared to banknote acclimated for operating activities of $197 actor in the aboriginal division of 2015. As of March 31, 2016, we had absolute debt of $5.677 billion, banknote and banknote equivalents of $338 actor and alive basic of $556 million. Refer to Liquidity and Basic Resources for added discussion.
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Quarterly After-effects and Business Overview
Net Sales
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The afterward table provides our net sales by business and the about change on an as appear and connected bill basis. The connected bill beforehand ante in the tables beneath can be recalculated from our net sales presented in Note K - Segment Reporting to our unaudited abridged circumscribed banking statements independent in Item 1 of this Quarterly Report on Form 10-Q. Connected bill beforehand rates, which exclude the appulse of changes in adopted bill barter rates, are not banking measures able in accordance with U.S. GAAP and should not be advised in abreast from, or as a backup for, the best anon commensurable GAAP banking measure. Refer to Added Information for a added altercation of management's use of this non-GAAP banking measure.
Growth ante are based on actual, non-rounded amounts and may not recalculate precisely.
Cardiovascular
Interventional Cardiology
Our Interventional Cardiology business develops, articles and markets technologies for diagnosing and alleviative coronary avenue ache and added cardiovascular disorders. Artefact offerings accommodate coronary stents, including drug-eluting and bald metal stent systems, airship catheters, rotational atherectomy systems, adviser wires, adviser catheters, embolic aegis devices, bridge and re-entry accessories for the analysis of chronically chock-full coronary vessels, analytic catheters acclimated in percutaneous transluminal coronary angioplasty procedures, and intravascular ultrasound (IVUS) imaging systems. We additionally action structural affection articles in assertive markets, which accommodate a accessory for transcatheter aortic valve backup (TAVR) and a accessory advised to abutting the larboard atrial addendum in patients with atrial fibrillation that are at accident for ischemic stroke.
Our drug-eluting stent systems accommodate our abutting bearing SYNERGY(TM) Everolimus-Eluting Platinum Chromium Coronary Stent Arrangement and our Promus PREMIER(TM) Everolimus-Eluting Platinum Chromium Coronary Stent System, both of which are advised to accommodate physicians with bigger drug-eluting stent achievement in alleviative patients with coronary avenue disease. SYNERGY(TM) appearance an ultra-thin abluminal (outer) bioabsorbable polymer coating, while PREMIER(TM) appearance a different customized platinum chromium admixture stent architectonics and an added stent commitment system. We accustomed FDA and Japanese authoritative approval of the SYNERGY(TM) technology in the fourth division of 2015 and we launched SYNERGY(TM) in Japan in the aboriginal division of 2016.
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Our structural affection artefact offerings accommodate our Lotus(TM) Valve System, a accessory for TAVR, and our WATCHMAN(R) accessory advised to abutting the larboard atrial addendum in patients with non-valvular 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. The Lotus(TM) Valve Arrangement is CE-marked in the EU, and in the U.S., it is an investigational accessory and not accessible for sale. At the end of 2015, we completed acceptance in our REPRISE III analytic airship and apprehend FDA approval of the Lotus Valve Arrangement in backward 2017. The WATCHMAN(R) Larboard Atrial Addendum Closure 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, as able-bodied as the U.S. afterward FDA approval in March 2015. We accept that Watchman(R) will be the alone LAAC technology commercially accessible in the U.S. for assorted years. In November 2015, we accustomed CE Mark for our abutting bearing device, Watchman FLX(TM). Shortly afterwards approval, we began a European antecedent bazaar absolution of Watchman FLX. The antecedent bazaar absolution was abeyant abreast the end of the aboriginal division of 2016 due to a college than accepted amount of accessory embolization. We are evaluating abstracts from the antecedent bazaar release.
Our net sales of Interventional Cardiology articles of $548 actor represented 28 percent of our circumscribed net sales for the aboriginal division of 2016. Our Interventional Cardiology net sales added $53 million, or 11 percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $19 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $72 million, or 13 percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily accompanying to sales of our drug-eluting stents, led by our advancing all-around barrage of the SYNERGY(TM) stent, our WATCHMAN(R) accessory afterward the U.S. bartering barrage during the aboriginal division of 2015, and our Lotus(TM) Valve Arrangement in the EU; forth with operational beforehand in our added cardiology artefact lines, including our OptiCross(TM) Coronary Imaging Catheter and our iLab(R) Polaris PCI Advice Arrangement artefact offerings.
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, forth with assertive articles to treat, analyze and affluence assorted forms of cancer.
Our net sales of PI articles of $242 actor represented 12 percent of our circumscribed net sales for the aboriginal division of 2016. Our PI net sales added $25 million, or 12 percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $7 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $32 million, or 14 percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily apprenticed by revenues from articles acquired as allotment of our 2014 accretion of the Interventional Division of Bayer AG, as able-bodied as beforehand in our amount PI franchises, decidedly our stent authorization afterward FDA approval and barrage of our Innova(TM) Vascular self-expanding stent arrangement in the U.S., our interventional oncology authorization and our drug-eluting artefact franchise.
On December 31, 2015, we acquired the interventional radiology portfolio of CeloNova Biosciences (CeloNova). The accretion includes drug-eluting microspheres advised to be loaded with chemotherapy drugs for commitment to annihilative tumors, and all-around embolic articles acclimated to amusement uterine fibroids and added conditions. We accept the CeloNova aggregation and technologies will advice beforehand our position and beforehand contour aural the interventional oncology market.
Rhythm Management
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Cardiac Accent Management
Our Cardiac Accent Administration (CRM) business develops, articles and markets a array of implantable accessories including implantable cardioverter defibrillator (ICD) systems and implantable cardiac resynchronization analysis defibrillators, including the world's aboriginal and alone commercially accessible subcutaneous implantable cardioverter defibrillator, the S-ICD(R) System, and pacemaker systems that adviser the affection and bear electricity to amusement cardiac abnormalities. In addition, in best geographies, our implantable accessory systems accommodate our alien LATITUDE(R) Patient Administration System, which enables physicians to adviser accessory achievement remotely, acceptance for added common ecology in adjustment to adviser analysis decisions.
Our net sales of CRM articles of $433 actor represented 22 percent of our circumscribed net sales for the aboriginal division of 2016. Our net sales of CRM articles decreased $23 million, or bristles percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $11 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, decreased $12 million, or three percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year abatement was primarily apprenticed by lower volumes of backup procedures for our defibrillators due to their constancy and cardiac resynchronization analysis defibrillator (CRT-D) sales declines in assertive regions due to aggressive technology offerings. In addition, our transvenous implantable cardioverter defibrillator business accomplished denovo allotment loss
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to alluring resonance imaging (MRI) technologies in baddest geographies. Our all-around pacemaker acquirement added on a connected bill base apprenticed by the connected acceptance of the ACCOLADE(TM) ancestors of pacemakers and cardiac resynchronization analysis pacemakers, and the Ingevity(TM) MRI pacing advance in baddest markets, and allowances from our sales accord acceding with Preventice, Inc.
The afterward are the apparatus of our CRM net sales:
We bazaar several curve of ICD's, including our DYNAGEN(TM) EL , DYNAGEN(TM) MINI, INOGEN(TM) EL and INOGEN(TM) MINI. MINI is the world's smallest, thinnest ICD, and EL (extended longevity) is the world's longest abiding ICD due to our proprietary EnduraLife(TM) array technology. In addition, we action our EMBLEM(TM) S-ICD system, which affords physicians the adeptness to amusement patients who are at accident for abrupt cardiac arrest after affecting the affection or advancing the vasculature. Our EMBLEM(TM) S-ICD arrangement offers greater longevity, LATITUDE(R) Patient Administration alien ecology technology and abate admeasurement as compared to the above-mentioned generation. We additionally action several curve of CRT-D systems, including our X4 band of quadripolar systems and X4 quadripolar LV leads, and the ACUITY(TM) PRO advance commitment system. We accomplished the abounding barrage of our X4 quadripolar CRT-D systems in Japan and Australia in the aboriginal division of 2015 and in February of 2016 we accustomed FDA approval for the Acuity(TM) X4 Quadripolar lead. The U.S. barrage was accomplished backward in the aboriginal division of 2016.
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, and the Rhythmia(TM) Mapping System, a next-generation, catheter-based, 3-D cardiac mapping and aeronautics band-aid advised to advice analyze and amusement a array of arrhythmias.
Our net sales of Electrophysiology articles of $59 actor represented three percent of our circumscribed net sales for the aboriginal division of 2016. Our Electrophysiology net sales added $1 million, or three percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $2 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $3 million, or bristles percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily apprenticed by added sales of our Rhythmia(TM) Mapping Arrangement and accompanying products. In the aboriginal division of 2016, we accomplished a abounding European barrage of our Blazer IntellaNav OI catheter which is acclimated with our Rhythmia(TM) Mapping System. In May of 2016, we accustomed FDA approval for IntellaNav(TM) XP and the IntellaNav MiFi(TM) XP navigation-enabled ablation catheters that will be acclimated with the Rhythmia(TM) Mapping System. We additionally accustomed FDA approval for our Blazer(TM) Open Irrigated Arrangement with Atrial Flutter adumbration with the abounding commercialization accepted in the added division of 2016.
MedSurg
Endoscopy
Our Endoscopy business develops and articles accessories to amusement a array of medical altitude including diseases of the digestive and pulmonary space.
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Our net sales of Endoscopy articles of $333 actor represented 17 percent of our circumscribed net sales for the aboriginal division of 2016. Our Endoscopy net sales added $28 million, or nine percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $9 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $37 million, or 11 percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily apprenticed by beforehand beyond several of our key artefact franchises, including our biliary accessory authorization with the barrage of SpyGlass(TM) DS Direct Visualization Arrangement and our AXIOS Stent and Electrocautery-Enhanced Commitment Arrangement for endoscopic ultrasound-guided transmural arising of pancreatic pseudocysts; our metal stent authorization apprenticed by our Biliary WallFlex(R) artefact family; and our biopsy and polypectomy franchises, featuring our industry arch articles such as forceps and snares.
On April 2, 2015, we acquired Xlumena, Inc. (Xlumena), a medical accessory aggregation that developed minimally invasive accessories for Endoscopic Ultrasound (EUS) guided transluminal arising of targeted areas aural the gastrointestinal tract.
Urology and Pelvic Health
Our Urology and Pelvic Bloom business develops and articles accessories to amusement assorted urological and pelvic conditions. Our net sales of Urology and Pelvic Bloom articles of $228 actor represented 12 percent of our circumscribed net sales for the aboriginal division of 2016. Urology and Pelvic Bloom net sales added $105 million, or 85 percent, in the aboriginal division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $8 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $113 million, or 87 percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily attributable to acquirement of about $98 actor from sales of articles acquired with the AMS Portfolio Accretion forth with beforehand beyond all of our added all-around franchises.
On August 3, 2015, we completed the AMS Portfolio Acquisition, which included the men's bloom and prostate bloom businesses, from Endo All-embracing plc., for $1.616 billion in up-front banknote added accompanying fees and expenses, and a abeyant added $50 actor in application based on 2016 sales. The AMS Portfolio Accretion includes the accretion of arch articles for the analysis of a array of urologic conditions, including the minimally invasive GreenLight XPS(TM) and HPS(TM) Laser Analysis Systems for alleviative amiable prostatic hyperplasia, the AMS 700(TM) Inflatable Penile Prosthesis for alleviative arrect dysfunction, and the AMS 800(TM) Urinary Control Arrangement for alleviative macho accent urinary incontinence.
Neuromodulation
Our Neuromodulation business offers the Precision(TM) and Attention Spectra(TM) Spinal Cord Stimulator (SCS) Systems and, in Europe, the Attention Novi(TM) SCS System, acclimated for the administration of abiding pain. The Attention Spectra Arrangement is the world's aboriginal and alone 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. The Attention Novi(TM) SCS Arrangement offers patients and physicians with the aboriginal 16-contact aerial accommodation primary corpuscle (PC), additionally referred to as non-rechargeable, accessory for the analysis of abiding pain. We accept CE mark approval for Vercise(TM) Deep Brain Dispatch (DBS) Arrangement in Europe for the analysis of Parkinson's disease, agitation and awkward primary and accessory dystonia, a acoustic movement ataxia characterized by automatic beef contractions. In September 2015, we acquired CE mark approval for the Vercise(TM) PC DBS Arrangement with its Neural Navigator(TM) programming software and Vercise Cartesia(TM) Directional Lead. The arrangement allows for programming flexibility, advised to amusement a greater ambit of patients throughout their ache progression. The Cartesia(TM) Directional Advance uses multi-directional dispatch for greater precision, advised to abbreviate ancillary furnishings for patients. We are currently in U.S. cardinal airship with our Vercise(TM) DBS Arrangement for the analysis of Parkinson's disease.
Our net sales of Neuromodulation articles of $121 actor represented six percent of our circumscribed net sales for the aboriginal division of 2016. Our Neuromodulation net sales added $7 million, or six percent, in the aboriginal division of 2016, as compared the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $2 actor in the aboriginal division of 2016 due to changes in adopted bill barter rates, added $9 million, or eight percent, as compared to the aforementioned aeon in the above-mentioned year. This the year-over-year access was primarily apprenticed by allotment assets from our CoverEdge(TM) 32-contact Paddle Advance and connected acceptance of the Attention Spectra(TM) SCS Arrangement in the U.S. and added net sales in Europe apprenticed by our Vercise(TM) DBS Systems and non-rechargeable Attention Novi(TM) SCS System.
Emerging Markets
As allotment of our cardinal imperatives to drive all-around expansion, declared in our best contempo Annual Report on Form 10-K, we are gluttonous to abound net sales and bazaar allotment by accretion our all-around presence, including in Emerging Markets. We ascertain Emerging Markets as 20 countries that we accept accept able beforehand abeyant based on their bread-and-butter conditions, healthcare sectors, and our all-around capabilities. We are gluttonous to aggrandize our attendance and strengthen relationships in adjustment to abound net sales and market
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share aural our Emerging Markets, and we accept added our advance in basement in these countries in adjustment to aerate opportunities. Our Emerging Markets net sales represented about 10 percent of our circumscribed net sales in the aboriginal division of 2016 and 2015.
May 04, 2016
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