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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 accepted 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 September 30, 2016
Our net sales for the third division of 2016 were $2.105 billion, as compared to net sales of $1.888 billion for the third division of 2015, an access of $217 million, or 11 percent. Our adapted net sales, which excludes a absolute appulse of $4 actor in the third division 2016, due to changes in adopted bill barter rates, added $213 million, or 10 percent, as compared to the aforementioned aeon in the above-mentioned year.1 This access included adapted net sales of about $26 actor in the third 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 third division of 2016 was $228 million, or $0.17 per share. Our appear after-effects for the third division of 2016 included an abstract asset crime charge, acquisition-related net credits, restructuring and restructuring-related net charges, litigation-related net accuse and acquittal amount accretion $140 actor (after-tax), or $0.10 per share. Adapted net income, which excludes these items, for the third division of 2016 was $368 million, or $0.27 per share.1 Our appear net accident for the third division of 2015 was $198 million, or $(0.15) per share. Our appear after-effects for the third division of 2015 included abstract asset crime charges, acquisition-related net charges, restructuring and restructuring-related net charges, litigation-related net charges, alimony abortion accuse and acquittal amount accretion $524 actor (after-tax), or $0.39 per share. Adapted net income, which excludes these items, for the third division of 2015 was $326 million, or $0.24 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 U.S. GAAP, are not able in accordance with U.S. GAAP. Refer to Additional Information for a altercation of management's use of these non-GAAP banking measures.
Table of Contents
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 20.2 actor shares for the three months concluded September 30, 2015 for all or a allocation of these non-GAAP adjustments.
Cash acclimated for operating activities was $32 actor in the third division of 2016, as compared to $408 actor in the third division of 2015. As of September 30, 2016, we had absolute debt of $5.425 billion, banknote and banknote equivalents of $237 actor and alive basic of $165 million. Refer to Liquidity and Basic Resources for added discussion.
Table of Contents
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Nine Months Concluded September 30, 2016
Our net sales for the aboriginal nine months of 2016 were $6.195 billion, as compared to net sales of $5.499 billion for the aboriginal nine months of 2015, an access of $696 million, or 13 percent. Our adapted net sales, which excludes a abrogating appulse of $80 actor on our aboriginal nine months of 2016 net sales, due to changes in adopted bill barter rates, added $776 million, or 13 percent, as compared to the aforementioned aeon in the above-mentioned year.1 This access included adapted net sales of about $226 actor in the aboriginal nine months of 2016, with no above-mentioned year aeon accompanying net sales, due to the accretion of the AMS Portfolio Acquisition, as ahead described. 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 nine months of 2016 was $223 million, or $0.16 per share. Our appear after-effects for the aboriginal nine months of 2016 included an abstract asset crime charge, acquisition-related net charges, restructuring and restructuring-related net charges, litigation-related net charges, and acquittal amount accretion $896 actor (after-tax), or $0.65 per share. Excluding these items, net assets for the aboriginal nine months of 2016 was $1.119 billion, or $0.81 per share.1 Our appear net accident for the aboriginal nine months of 2015 was $97 million, or $(0.07) per share. Our appear after-effects for the aboriginal nine months of 2015 included abstract asset crime charges, acquisition-related net charges, restructuring and restructuring-related net charges, litigation-related net charges, debt concealment charges, alimony abortion accuse and acquittal amount accretion $1.002 billion (after-tax), or $0.74 per share. Excluding these items, net assets for the aboriginal nine months of 2015 was $905 million, or $0.67 per share.1
1Adjusted 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 U.S. GAAP, are not able in accordance with U.S. GAAP. Refer to Additional Information for a altercation of management's use of these non-GAAP banking measures.
Table of Contents
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 21.5 actor shares for the nine months concluded September 30, 2015 for all or a allocation of these non-GAAP adjustments.
Cash provided by operating activities was $506 actor in the aboriginal nine months of 2016, as compared to banknote provided by operating activities of $271 actor in the aboriginal nine months of 2015. The access in banknote provided by operating activities for 2016 was primarily due to the abatement in litigation-related payments for the aboriginal nine months of 2016 as compared to the aforementioned aeon in 2015.
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Quarterly After-effects and Business Overview
Net Sales
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 U.S. GAAP banking measure. Refer to Additional Information for a added altercation of management's use of this non-GAAP banking measure.
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Growth ante are based on actual, non-rounded amounts and may not recalculate precisely.
Growth ante are based on actual, non-rounded amounts and may not recalculate precisely.
Table of Contents
Cardiovascular
Interventional Cardiology
Our Interventional Cardiology business develops, articles and markets technologies for diagnosing and alleviative coronary avenue ache and added cardiovascular disorders including structural affection conditions. 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. Our structural affection articles offerings 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 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 launched in the U.S. in the fourth division of 2015 and in Japan in the aboriginal division of 2016.
Our structural affection artefact offerings accommodate our Lotus(TM) Valve Systems, accessories 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 Systems abide of a stent-mounted tissue valve prosthesis and catheter commitment arrangement for advice and adjustment of the valve. The aboriginal Lotus(TM) Valve Arrangement as able-bodied as our abutting bearing Lotus EDGE arrangement are CE-marked in the European Union (EU), and in the U.S. they are investigational accessories and not commercially available. In October 2016, we abeyant our bound barrage and accomplished a autonomous abatement of acreage account of Lotus EDGE arrangement due to letters that in some cases the accessory could not be absolutely bound during the procedure. We are evaluating abstracts from the antecedent bazaar absolution to actuate a basis cause. At the end of 2015, we completed acceptance in our REPRISE III analytic airship and apprehend FDA approval and to arise barrage 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. Afterward an all-encompassing abstracts evaluation, we accept absitively to accompany abeyant architecture enhancements above-mentioned to abiding a abutting bearing accessory to market.
Our net sales of Interventional Cardiology articles of $568 actor represented 27 percent of our circumscribed net sales for the third division of 2016. Our Interventional Cardiology net sales added $68 million, or 14 percent, in the third division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a abrogating appulse of $1 actor in the third division of 2016, due to changes in adopted bill barter rates, added $69 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 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 articles to treat, analyze and affluence assorted forms of cancer.
Our net sales of PI articles of $257 actor represented 12 percent of our circumscribed net sales for the third division of 2016. Our PI net sales added $30 million, or 12 percent, in the third division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a absolute appulse of $3 actor in the third division of 2016, due to changes in adopted bill barter rates, added $27 million, or 11 percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily apprenticed by revenues from our Atherectomy and Thrombectomy systems, 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. and Japan, our interventional oncology authorization and our drug-eluting artefact franchise.
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Table of Contents
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
Cardiac Rhythm Management
Our Cardiac Rhythm 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 accepted ecology in adjustment to adviser analysis decisions.
Our net sales of CRM articles of $467 actor represented 22 percent of our circumscribed net sales for the third division of 2016. Our net sales of CRM articles added $16 million, or four percent, in the third division of 2016, as compared to the aforementioned aeon in the above-mentioned year. Our adapted net sales, which excludes a absolute appulse of $1 actor in the third division of 2016, due to changes in adopted bill barter rates, added $15 million, or three percent, as compared to the aforementioned aeon in the above-mentioned year. This year-over-year access was primarily apprenticed by able all-around pacemaker beforehand including the barrage of our ACCOLADE(TM) ancestors of alluring resonance imaging (MRI) safe pacemakers and the Ingevity(TM) MRI pacing advance in the U.S., all-around beforehand from our quadripolar cardiac resynchronization analysis pacemakers (CRT-P), able Japan CRM sales with S-ICD, constant European Sales growth, and allowances from our sales accord acceding with Preventice Solutions, Inc., (Preventice). In the U.S., the third division of 2016 represented a abounding division of U.S. low voltage MRI commercialization, the additional division of commercialization for our Acuity X4 quadripolar LV pacing advance in both the cardiac resynchronization analysis defibrillator (CRT-D) and CRT-P franchises, and represented aboriginal all-around commercialization of our EMBLEM(TM) MRI S-ICD system. These launches added than account lower volumes of backup procedures for our defibrillators due to their continued constancy and burden from aerial voltage MRI technologies primarily in the U.S. On April 30, 2015, we acquired a 27 percent buying absorption in Preventice, which includes 18.5 percent of Preventice's accepted stock. Preventice is a privately-held aggregation headquartered in Minneapolis, MN, and a arch developer of adaptable bloom solutions and services. In accession to the disinterestedness agreement, we entered into a bartering acceding with Preventice, beneath which we became Preventice's exclusive, accepted sales and business representative. In October 2016, administration notified Preventice of our absorbed to abolish the bartering acceding and will alteration the sales force aback to Preventice aural the abutting twelve months beneath the acceding of the agreement.
The afterward are the apparatus of our CRM net sales:
We bazaar several curve of ICD's, including our band of MINIs, the world's smallest, thinnest ICD, and our band of ELs (extended longevity), 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. In April 2016, we accustomed CE Mark approval and in August 2016 we accustomed FDA approval for the new EMBLEM(TM) MRI S-ICD System, as able-bodied as alluring resonance codicillary labeling for all ahead built-in EMBLEM S-ICD Systems. The commercialization and cycle out of this technology will abide into the fourth division of 2016. We additionally action several curve of CRT-D systems, including our X4 band of quadripolar systems and Acuity 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.
. . .
Nov 03, 2016
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