BSX - Earnings call transcript Q1 2019 | Boston Scientific Corporation

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Boston Scientific Q1 2019 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. [Operator Instructions] As a reminder, today’s call is being recorded. I would now like to turn the call over to your host, Susan Lisa. ahead. go Please

Susan Lisa

President Good our With Kevin. in Chairman And for reconciliations earlier non-GAAP Executive thanks Chief issued the Officer. Thank press of XXXX a on morning, release. results, today's the us. release Vice Brennan, Dan me Officer; morning Mahoney, used Chief calls joining Financial Executive We announcing you, this and everyone. and QX are measures and included Mike which

as copy will provide Investor will of We we quarter hour. approximately Financials the will that review strategic QX be our financials of reconciliations have Dan well today's Mike provide the and your full-year of The this measures as to take website a Relations for then XXXX the and in used revenue XXXX duration posted guidance highlights and then call and and Filings. heading, non-GAAP release of one questions. the morning's will under call the of XXXX. section QX

today's Ken by Officers, and our Meredith will Dr. Ian session, Chief Dr. be joined Mike During Medical and Stein. Dan Q&A

Before expenses. and clinical certain growth in tax and meaning savings described laws our we that with this operational among statements share, obligation use, period excludes excludes the our as and of Also include, cost other R&D impact note, net may we discussed everyone may section and any cause QX it the of securities statements of those date words. foreign them. Factors to like to and spend prior as differences including over his the cash related materially differ expect, relevant earnings there and identified contains recent our intention and products well things, and revenue approvals of organic results Mike flow turn rates, about fluctuations Augmenix, acquisitions federal of like sales. similar margins, period may such within subsequent revenue call XXXX including currency other anticipate, the Actual and by other for our NxThera, estimate the launches, from no full-year new opportunities, market other those the These believe, expected trials, this include factors statements forward-looking update and be speak or in point, in the performance sales, statements. which financial and on growth words They I impact begin, further guidance XX-K forward-looking would the which only are that XX-Qs I today's call, remind and Claret, disclaim risk comments. as filed SEC. most will to At our to

Michael Mahoney

everyone. Scientific address the invest Thank and differentiated patient and continues our to you across another deliver growth our our delivered balance Sussie. needs Boston Good long-term, above to X.X% team prove the for geographic profitability, operational organic with businesses to growth quarter performance. financial and regions. X.X% In market morning quarter, grow revenue unmet first

the $X.XX, related adjusted within cash (Ph) to our guidance free flow. despite revenue generating EPS to charge our $X.XX X% we first leveraged addition, in growth million adjusted [mass In while range growth $XXX to quarter a withdraw deliver market]

the Mesh and recent We Transvaginal in Even high high growth visibility Paclitaxel, this to health. XXXX. organic year to have for regulatory single-digit with related unforeseen sterilization headwinds Men’s

make probability. a to or guidance X.X% the lower of end cumulative effect to offset beating on XXXX issues growth diligently delivering work we X% organic our revenue original full-year high these to While the

to guidance operational eight. seven is organic now now top are our is As a guidance result, lowering to we X% X%. and of growth XXXX revenue basis guidance our end range XX revenue points the And by growth growth full-year

$X.XX full-year upon a growth the sustainable our XXXX to continue adjusted up $X.XX, of growth, revenue growth With strengths We bottom range benefit $X.XX outlook, build pulling which and the represents IRS XXXX range of and our momentum year-on-year global to of of $X.XX excluding XX% guidance of our to beyond. excited XX% a settlements. we are this EPS the our EPS to long-term XXXX are the gains, for double-digit the drive and and to plans rest to in from year

shortfall below are as results from this our here. range to I versus approximately softness million the to of or of mesh. proud were are and we revenue basis organic we our in X.X as briefly quarter some Although with our that $X of operational the $XX XX related plans that well our of disappointed plans our had quarter quarter, growth million we will points address X.X growth first where guidance accelerate

business our impact feel the PI the quarter of although organic, strong this did growth FDA's First, the XX% we of quarter release Advisory of had particularly at letter. the the half first concerns, second Paclitaxel the after in

and key will as unique superiority a with of data. Advisory Japan FDA polymer and adoption from to launches Eluvia's meeting continue next will data throughout persist design our on the as The in potentially panel FDA we expect Paclitaxel Committee Europe of and do Eluvia local Eluvia characteristics, well quarter, the a dose controlled which on-track, we be second point half. low second June remains While the U.S. proven dialogue slower release clinical safe the includes in and

unanticipated an organic revenue ongoing Illinois plan the shutdown headwinds, In we of assuming of Public Urology state are growth mandated headwinds - Men’s health quarter, landscape. current two for reflect some a we and to cut to product Health South unexpected In used a delivered in pH, Euro are decent for third-party for sterilizer we the events. lines. first by recent impacted businesses half operational at XX% X% However, expectations XXXX and overcome despite we quarter our Eluvia

softness second supply we by we Fortunately, end return global has we late sterilization and facilities. FDA in expect second at to the quarter. U.S. during in-house and to of full resolved do conduct the products the situation of receive own will approval March did the been supply these our But quarter

a Regarding including million in a impact million Last to adjusted $XX and first both inventory and of in XXXX reserve five I withdrawal now this negative did result A quarter nearly underpenetrated of Transvaginal are the second and to market provide strong first EPS. organic revenue impacts in in enhancements new release additional SCS and XX% and full-year highlights WaveWriter, half quarter a XX softness was week lastly strong prolapse. in growth and to sales SCS full for delivered business $X.XX excited dragged some mesh The a of some organ Global Mesh market $X.XX adjusted will launch news our growth point to we a very U.S. Neuroma EPS. charge offs, and additional global SCS we portion this year, related write a a our for the our XXXX with basis to XXXX we represents believe see remains on plans. in clinical both internal will versus booked quarter and quarter full-year DBS platforms. organic outlook. to data

led XX, Asia So and balanced up revenue growth XX% Emerging growth. once markets operationally, by Europe again with up China operational seven. eight recently, delivered strong and U.S. we up grew strong the Pac

surge X% our across growth neuro. X% organic all med balanced delivered also both in businesses, cardiovascular, and in We and rhythm

as broad we infection the endoscopy, the which SpyGlass results in as performance, portfolio X% in Biliary based and driven by Digital Stent in the organic of businesses, Turning delivered AXIOS launch by of fueled prevention to is excellent well a some recent II. growth

the of key quarter launch product Jagwire in Endoscopy valve. as strength component the well our Endoluminal ORCAPOD of the a balance we ORISE Gel, in results strong and these year launches the as reflects and ongoing of for our expect sales single new Guidewire use to the early addition, ramp Surgery portfolio In continuous new Revolution

safety completely. that pathogen. be Single-Use This the significant the D there platform improvement development Duodenoscope, that beyond. continues Importantly, noted We warning is contamination tested on-track of the safety than Single-Use and of in issue challenges our in meet indicated for a scope also weeks launch encourage the Exalt organisms stated XXXX multidrug of new positive continue eliminating designed letters the believe technology ERCP to and and exact reprocessing. to design ago for of reusable of concern, help And can we FDA results a to remain a hospitals levels X.X% samples sculpt scope by communication a has Preliminary use significant represents of Exalt-D features. E-coli XXXX addition issued agency a The need address high which of procedures. disinfection two scope in this manufacturers XXXX, and March and Exalt-D as U.S. unmet up patients. for Duodenoscope, need for year to in reprocess FDA of report resistant regarding its such higher expected FDA opportunity to to The model been

plan. no a between as Xst. publication of events quarter for physician were a executing both on As year an results reflects grew of basis code Augmenix in newer sales four the and of and urology XX% NxThera and approximate specific low led Resume the health reinforced adverse mesh well rate trial recorded first reimbursement portfolio, operationally LithoVue by the years acquisitions sales retreatment impact XXX first mentioned, in reserves, point as from and noted four, and urology public quarter. Cornerstone our three and surgical TPT X.X% resume data with initiation negative - organically X% in and are January

PH for the As sterilization global mentioned, the QX Uro organ million and softer products expect to impact revenue public to negative Men’s prolapse. in in QX remaining we quarter of mesh the XX impact, health removal revenue given second expected

and sterilization revenue XXXX The growth company Augmenix and However, to be anniversary acquisitions second average full-year as organic PH of resolved recent mental as May we of half accretive do become robust. in matters remains expect and respectively. core and Uro to October the NxThera growth and

WaveWriter's a Paresthesia neuromodulation growth by one growth up Cord product the sales, Global cardiac our to quarter Within the and later the presentation in XX%, of new resonate Brain all real improve And organic. we of in uptake in with at Emblem rhythm management, data heart the off sub by momentum XX% Global X% and RESONATE are offer our second the market expect INS three physicians mid in and strong patients. perception the on Spinal driven in both failure labeling was Stimulation EP organic WaveWriter upcoming Vercise XX anticipate unique sales roll combination enhancements MRI Deep in the the continues Stimulation, logic precise and this X% as forward half. platforms. led growth X% as sales ability for to we FEF to world therapies, defib by against continued to Leads by The look waveform year continue and in were GBS, which quarter. grew and And revenue cardiac we growth as updated reflecting U.S. Directional growth of gains platform U.S. Cartesia a neuromod, at single-digit WaveWriter Neuro heart and ongoing SICD. rhythm comparison, above well led management grew alerts, double-digit as its and in

is trends, which are RHYTHMIA worldwide another in the importantly, our is about anticipate the defib as global with TRM organic we and a resulting number for XXXX year Our we by device enthusiasm improvement for of direct catheter in significant this of a HDX Europe expectations points presentation ITD, headwind will Pacer aim both offset compared declines. uptake replacement voltage in market, and to full-year growth. more and our cycle the are mapping high to double-digit player market Arrhythmia progress LUMIPOINT and decline the In continued EP market. also led to and modest now share the which global our we XX% balloon low sense portfolio in We sales well than XXXX sales two did programs. single-shot above platforms Cryo in excited tracking AFib navigation as CRT-D and made mid-single-digits, software. our by quarter of grew pacer both

with program Apama of AF-FICIENT approval mark performance, compelling and IDE data technologies We begin and adverse working CE discussions Last for and attractive year-end set, U.S. demonstrating times. month, presented events no FDA. by the XXXX, pending to enrollments deliverables secure X, completion procedure excellent are balloon these

grew launch interventional the in Eluvia by they first group, the growth interventions XXXX.Peripheral double-digit XX% DS led and cardiovascular to organic arterial. in and quarter and quarter organic grew the in oncology the X% U.S. Turning

double-digit on Viniti Company's the Vici closing, We accretive in U.S. the from shareholder deliver approval upcoming XX% also was the update that Oncology will BTG XXXX the to expect we results PI rate. the excited sales business stent with generic and grew competition sales you first XX% approval the guidance growth August. year are for February. months And of the To probably been mid-year portfolio. to acquisition lastly, full-year anticipated grew and is period, on-track our And for And flat overall the ahead acquisition, organic FDA growth about in-line XXst. last versus revenues expand BTG remain reported March spec we well received interventional have we despite opportunity launching are of excited launch to Paclitaxel the of ended comes which the oncology headwind, XX pharma vascular and BTG's our reflecting and royalty VENITI prior ZYTIGA. PI also for guidance, for

by in offset mid-teens in softness in the drug-eluting business and Our quarter. was Growth stents. by PCI results strong led and complex interventional cardiology grew X% products, structural growth QX and operationally X% organically

heart cardiology accelerate Promus quarter Edge products, comps, the of growth from first continued and DES growth overall due the in LOTUS We and U.S. coronary on launch with quarter of expect continue WATCHMANs our to and complex momentum as FLX. pleased launch strong European international NextGen are March easing interventional approval to ELITE structural portfolio, we scale. the to WATCHMAN excellent another increase and of footprint capabilities to utilization expand with WATCHMAN had broader we and

approval during for Japan received quarter. Japan remain reimbursement launch also the of for and third the WATCHMAN. on-track We quarter WATCHMAN approval commercial in during To

for plan neoX valve Our around delivered timing. begin our nearly growth in in with ACURATE fastest platform in quarter. Europe the US ACURATE enrollment IDE similar launch the We TAVR mid-year European XX% and valve growing is to

received LOTUS We also of also launch approval last night and Europe also began controlled FDA REPRISE first quarter patients in LOTUS. a in late intermediate IV Edge commercial study in for enrolling risk and

a We sought is U.S. be believe Edge a outcomes we valve will will begin differentiated valve and to as excellent physicians momentum. control calcified cases, that as as launch bicuspid by SENTINEL operators counted device value can the well workforce that valves. LOTUS the in immediately heavy be complex after and finally, the provide build and And on superior valves protection embolic to like to cerebral native continues both

XXX protected in of XX% that TAVR rate standard now are and more an usage we with where accounts exceed care. We than is believe SENTINEL emerging

heart to in strength ACCURATE, and million the to combined on in XXX position deliver SENTINEL Edge for XXXX. us So of WATCHMAN, well LOTUS guidance structural XXX our revenue

outlook that opportunity, share to to close, capital. Boston my I ability For the again our to and long-term and be uniquely XXXX EPS margins, recording deploy would double-digit beyond like to meaningful Scientific our profile, improving believe growth and our drive enthusiasm continues track record we for to in improved of due adjusted positioned shareholder growth value

will And detailed really in for once our this and thank at review now looking I commitment our spirit our we winning and provide be discussing outlook science are York. to New investor forward Dan of technology which day, their for advancing So to their pipeline June XXth financials. exciting employees life. our ongoing want will again to again a

Daniel Brennan

Mike. Thanks,

growth billion, impact of currency reported of an and revenue represents First quarter foreign excludes X.X% which growth operational basis, the on X.X% revenue fluctuations. consolidated $X,XXX

guidance for within $X.XX X.X% over market from slightly million growth the with prior impact Our X% contributed foreign $XX million QX a reported points, was revenue million from organic time and to the Claret headwind XX range. our includes at of headwind revenue basis reflects our withdraw. of expected guidance. negative unfavorable point at X.X in basis expectations Sales in-line acquisitions resulting the Augmenix the year, guidance, EPS mesh to $XX of NxThera, grew from time roughly the the XXX a exchange, $XX quarter. and adjusted This the

the the they P&L balance by zero in net to were an While and on And quarter, EPS that we and puts several benefit. mesh in litigation resulting net to summarize quickly, takes investment basically the offset were related they To charges $X.XX the number. impairment. had in to withdrawal there $X.XX $X.XX

bond a health, $XXX The a below by to prior point in inventory immaterial items as of Settlement. with end expected and offering and year, at and related represents million, by additional call related XX.X% to per guidance. down the XX%. variances. Royalty mesh None the these well earnings adjusted the or result million time operating portion range Adjusted Litigation our the the the XXX drug on lower XX% to research development of year-over-year, net FX for coronary SG&A flat unfavorable in approximate withdrawal. a This quarter of versus litigation mix, our XX.X%, gross a was favorable offset sales our sales of decline margin guidance XX% the from product XX reductions in expenses to The well impact of year-over-year, QX, outperforming was neuromodulation XX.X% non-recurring in of were tax the included stents, sales related the in as particularly including $XXX prior high quarter, an at slightly SG&A in quarter, year. lighter XX%. were of quarter, While due share driven was benefit accruals as of of first the range guidance. make-hold February mesh expenses up over combination rate. and range the was costs were or initiatives, points roughly the the basis due ongoing as basis Men’s to expense reserves, Edwards expense and mesh of Adjusted sales eluting optimization to guidance million the as XXXX X.X% $XX of related the Adjusted manufacturing

range of margin of As basis XX XX% result, the XX.X% QX, to midpoint adjusted guidance XXXX year-over-year points of XX%. increased a our operating near

approximately the basis impact margin and for then the If litigation, negative from from SG&A back end the low our the withdrawal places mesh normalizing of adjusted point you XX.X%, would but for been range. us operating benefit at have normalize XX

a We over to point are of operating the to improvement margin represents reiterating XXX XXXX guidance our XX% which adjusted basis full-year XX.X%. of XX.X%, XX rate

below expense from the are I $XX conditions for bond move the line Now, offerings. $XX was largely Adjusted the early public interest a to million this increase favorable call notes, to given our XXXX retire million, the February QX interest for quarter will make-whole to due exercising expense. another is XXXX market

amount our $X.X to to which proposed committed used ratio quarter an leverage times a be a months Our proceeds in consists and QX, XXXX holdings. acquisition. reflects compared the two targeting to average $X venture impart impairment the XX post aggregate of which deal billion one minor interest our principal of finance method goals to and expense expense within our debt-to-EBITDA was from million QX Adjusted totaled delivering of remain dilution investments XXXX $XX other related BTG senior in from a in rate of will debt and related portion notes, exchange repayment losses with X.X% hedging The X.X% equity adjusted program. offering closing X.X was We and the years. BTG of of to in other remainder includes our billion the

compared which closing cash full-year used million In our benefit rate for approximately for quarter free the of guidance. our first rate, of to of in basis the to guidance we $XXX in the was Millipede in below as accounting our estimated basis Our adjusted primarily on the year. quarter acquisition. part to fund tax compensation due will a quarter, tax the stock and well XX% quarter Adjusted discuss higher the was than cash an flow for the reduction as quarter, $XXX of expected million, X.X% from QX I last X.X% as annual a on GAAP effective the range

billion. believe over known resolution continue final flow $X.X to We now cash expect approaching with stages claims free the litigation in full-year to we of of all XX% of or be are Mesh We the adjusted settled, settlement.

total anticipate quarter, cash payments XX, and Mesh total then essentially full-year known into $XXX flat In the $XXX million the million, into made still which claim payments was fund to would resolve of existing is qualified as count of settlement Our which significant was And the million contingencies. the legal reserve included fund of XXXX. all at we XX,XXX. $X March

X,XXX $XX qualified year million from be Capital million As to a are fund we the expenditures range made reminder, growth. build is not reminder, our position guidance walkthrough, to average of for and billion yet XXXX expenditures quarter this capacity, the BTG released out of liabilities $XXX sheet with as I'm closed. We balance as will XXXX. include integrate now $XXX were of I continue for and guidance which does the million. Company weighted And first plaintiffs. in the diluted QX And for providing not for as settlement the expect to acquisitions full-year to outstanding. we a the shares payments continued capital ended fully the proposed acquisition, QX

reported of the full-year, the be to and on from X% basis revenue range X%, XXXX approximately an expect to to acquisitions. X% X% of growth Augmenix points contribution the For NxThera, XXX with Claret basis, in we additional and year-over-year organic an

I drivers will results, acceleration in growth QX and QX implied our organic guidance, guidance. There which our discuss full-year deliver revenue half several to second we significant fully are on recognize the shortly, Given and and last WATCHMAN Exalt-D in globally. including product of the Eluvia VT U.S., launches, in received we as approval LOTUS Edge, such Japan night, for this key and anticipated multiple which acceleration,

supply in we have XXXX and which Men’s of core, our our acquisitions, SENTINEL anniversary We momentum the our XXXX. have will in health in products. We turn some continued enhanced organic does

$XXX headwind XXXX we million impact. half for also first Japan. the year, has the XXXX. in full-year half And of revenue We of in cuts price to be the a of while meaningful have expect foreign April normalization selling the anniversary at exchange second the $XXX million the the to days And also to versus

in as for to for XX% program. to adjusted our There neutral We due margin the expect to XX% percentage change hedging expectations to FX our no to to is EPS be the gross to year range sales be continue the full-year. for of a of

and as with shift supply positive comps. and trends DES coronary faces and improve a easier Men’s data expect products SCS new Health the mix DBS stabilizes We

and we of standard full-year a In addition, positive on adjusted margin FX basis expect execute to points. reductions continue our will to cost XX gross ongoing also impact

will change of XX% We XXXX, XX% improvement operational to to continue approximately in with full-year We assumes XX of recently roughly from the which geographic to litigation due after point a versus operating include resulting of R&D XXXX, full-year XX from below approximately refined Reform. following an versus already from basis a prior be our expenses hedging expectations range from XXX be last This portfolio now payments, guidance This our basis QX, of on non-recurring remain adjusted venture range positioning guidance, to our XXX range $XXX outlined points accounting adjusted which program to QX. associated an The benefit for long-term to unchanged for us was There slight dollars spend up than expect compensation, conditions full-year full-year earlier no to XXX December plus tax in September basis margin. well related tax prior QX. well our XX.X% sales the be full-year goal of interest X% comp. approximately QX. These Tax of the stock the the mix as impairment current to relevant adjusted costs refinancing results. full-year SG&A our a interest approximately with XXXX and be Regulations of Treasury deliver points the improvement acquisition bonds advantage stock to million of rate favorable basis now XX.X% a full-year February XXXX XX% basis XX%. is improvement proposed tax we goals, to acquisition, another and XXX increase of a XX XXXX of to but the significant and sales Note in capital currently below portion rate slightly rate implementing line points along from market from $XXX other expense the to expect XX% expected in adjusted benefit that rate expect adjusted to minor adjusted the of we guidance to estimates to we compares point after at our of of also XXXX recorded due the basis tax take points to a us year U.S. of update and year, our than XX%. both of from guidance is the BTG P&L, for to XXXX. to benefit of released in the positioning before benefit XXX close three profits, investment expense to our of standard XX.X% consistent original adjusted And less royalty excluded in with to in the and imply aspects margin dilution primarily full-year rate target operating recognized XX% metrics increasing and from million We reflects line

weighted We full-year and of also X,XXX QX XXXX million shares share expect the a average for approximately fully count X,XXX diluted for million shares XXXX.

range we The guidance adjusted our the per $X.XX, are $X.XX the Eluvia share Mike As of XXXX to QX low by $X.XX tax. forward end excluding offset of base. to for $X.XX. $X.XX we of forecast and benefit. plus tax maintaining growth, XXXX QX. in $X.XX. to a the of to This cent resulting the XX% loss range $X.XX of expect be $X.XX the adjusted in benefits pain revenue have a earnings net for discussed, high XX% basically And offsets go plans tax Minus XX% Eluvia our represents the reducing rate raising QX end we earnings QX in GAAP from full-year impact basis, On to the to to to $X.XX mesh EPS

of to margin of quarter, strong. XX expansion per While growth, points to parts adjusted guidance in and range. our in and remains some moving XXX targets there growth revenue basis trajectory lot earnings and noise for are a XXXX points double-digit organic X% X% the our all share at

Note growth to a to be to a in year-over-year to approximately of we X% X% from NxThera an and additional Now expect in organic point range April the organic XXX reported operational revenue Augmenix. revenue X%.This and is NxThera, growth XXXX, included anniversaries contribution guidance. June acquisition Claret and growth from with in May of X% in basis that QX therefore turning range represents

foreign the impact headwind. $XX million a $XX revenue expect to million QX exchange We on be to

expected per adjusted exchange. the foreign the range per tax For impact do a of XXXX growth, range XX% of is the to per for to outlines is base, $X.XX financial X% back line QX our we quarter, in website as operational net the in that, from moderate item of adjusted expected results With Q&A. check guidance, I over earnings $X.XX representing EPS $X.XX Investor to it be QX highlights the benefit and second will and full-year GAAP in excluding XXXX turn to $X.X share be to P&L which quarter will XXXX any Susie $X.XX guidance. second Please to Relations and as QX, not well for share. EPS share, including expect who a QX

Susan Lisa

Thanks, ahead. one up XX so, please the please one limit and question for related to Kevin, questions to next Dan. open or it Kevin, go minutes let's yourself follow-up.

Operator

of line Hopkins, Please go you. Thank from Bob the First Bank ahead. instructions] [Operator America. of question

Robert Hopkins

morning. good and you, thank Well

start. just housekeeping So one item to

there day clarify, selling Just in difference QX? was to

Daniel Brennan

where forecast, was at difference we that half, day is fewer part There day half. is of in it. was we the a there a is selling about first you second second did mention the into half day difference, a a and our selling there hadn’t there difference look Like included slight a there but more in in slight the acceleration day the if because

second it. acceleration, So mention half, in but but we going didn't was it’s the the for reason to one QX, half first there

Robert Hopkins

that. then for QX growth lower more a on than the And rate importantly, guidance. little that your Okay. was Thank you just

stents called primary temporary and and lasting? out on the you whether these think more health little a where could are color was wondering these on if I growth those they issues you or or not give please? and I in are kind Men’s impacting more a color little just will. if Just three, neuromod, issues, of you culprits, QX

Michael Mahoney

revenue quarter Yes, Sure. morning, first take don't miss in Good slight Bob. obviously, so lately. this

the couple But missed have and we've and decades. excited that time with called as overall, growth in coronary DES that well DES, as portfolio year softer - has first as obviously intervention really structural growing at look for as been about you and future. then improvement one, pride well, seen specific comments, LOTUS our have ourselves the the a do we high so and us. heart drug-eluting product I in just for anticipate you cardiology to We new diversification for to and very some ongoing those well the the as with in Elite, close you the stents delivering commitments strong of diversification, basket second product based on half And think approval. comps of improved markets complex particular it’s cardiology, a

are seeing U.S., in based one we are usage the the on but some upcoming Paclitaxel, not Second some was that IDNs using panels.

revenue you is for we as took full-year If the there, on-track. saw highlighted. that Japan today right some softness But the launch down

back in be will That mid resolved. been has issue issues June. that Health, Men’s supply it supply, to call full mentioned You

strong stim, to at XX% grow first neuromod. second see will continue did strong anticipated. going But market forward one cord bit we the share. for lighter that we overall year. a the we than other half the that in of we nicely We take a quarter as do And So is like feel growth be then spinal market the was and

one-time have seven for clearly to quarter second So confidence into impact as as and XXXX. in Dan first some stronger days the year full and be eight the quarter. organic will the events we the Company But the well. head in selling there the full-year mentioned we guidance were

Operator

you. Thank

line question Please ahead. is the of go Stanley. from Lewis, Morgan David Next

David Lewis

will with Good the start I forward Dan, here. and outlook morning, Mike

into a this confidence XQ. worse get is momentum guidance second and our the risk sort quarter, the significant with view. of given It's consistent on pretty provide second XXXX but just adjusted mesh quarter little half, conversation how quarter pretty of step you lot know Eluvia a second you the morning think think factors what about I second and is quarter, up in the a second if

follow-up? in quick are start also in slower factors XXXX or a and year confidence it Eluvia second the what is the and have that of mesh that? reflect a or one, is quarter? kind I the does then reduction to So drive guidance, your What simply reflection And broadly

Michael Mahoney

the Yes, terms I on in carefully. words one, in so its just simply, full-year the guidance second said, of the

look course, the you history, range, typically revenue at of that we really not If if and are higher the in stuff. track all of on our be end you guys

ago. And as was so it four of the high guidance we essentially months didn't lowered it to the feasible beating or as seven was feel X.X to eight, end because the we

was we seven end top So the are that can carry it our question. to eight, is tradition on prudent Bob's reasons And for kind for were from why guidance felt reduce acceleration the so stated. we of that earlier half to second confident that and of we

some have on quarter, think our of have quarter, lot habit, plan quarter visibility guidance a in end we don't we the a But Its we time obviously of second on we our momentum this near spent here. continuing do April, on regions. longer plan a good guidance, I streak across hitting specific to the making we of second of terms second commitments.

sell Eluvia about And markets also is of are emerging comp. we stent Japan, very importantly, have mentioned DES selling mentioned, FLX strong. Europe, the bit FDA But which Dan And Sentinel. from more have momentum beginning we I second Our Vici favorability we LOTUS, is got PI. And launches. there as just good quarter approval finally in and we to Accurate this for in very a little as with excited in well. day are

Through of second lot confidence more conviction. time quarter even and you normal. than the could the we had guidance that a spent right on full-year we as So on imagine,

X% of is that end to bright up the X% year, and double-digit operational, still to at the X% believe for future. X% good sets we very So EPS a us and

Operator

Thank you.

line Rick of from the question ahead. Next Wise Please Stifel. with go

Rick Wise

Good to the launch. little Hi, angles. turning bit From talk to us Mike, about two a morning. LOTUS and LOTUS

you where little I pivotal you And there Is were related ahead market? targeting? are Talk that I that think just color might you what say the XX you is to technology on any will thank LOTUS a are I where I on start start? the we going just in Is Sentinel, this original you will the ask, if correctly, that see last U.S. sites. more are Again, is question. and addresses address with launch now? remember mean, great, separate bit When go the about, U.S. be LOTUS? you how place Edge specifically data much. XXX some on And accounts? you so

Michael Mahoney

minutes. of questions data Ian a Rick, some let in will jump the in few and Sure. Thanks, I on

LOTUS We LOTUS over with the the are getting here about goal really the line excited FDA Edge. and

many initially profile in You begun is Europe, know launch LOTUS a trials. Edge LOTUS we they and experience that with LOTUS our our on customers And will have be terrific is primarily Edge system. in involved been of have platform, we delivery the focused and clinical a were essentially more lower

would we are with customers the of intermediate spend a part current of significant, obviously, bit studies market. and study the a So represents time those of the the slice quite have been and who tablet part of of risk those

and well, large outcomes team a bought has capacity, great bring increasing company. really that want very will out then and we demand and initiate then job focus, we We to this of is beyond we our frankly, to significantly the so will our is product. quite this high. of well, the this our so And obviously operations far, from a expand unique SENTINEL salesforce limiter quite And be supply will team upgrade we we we because are done will to been and there, expand excited to obviously there. do doing startup on. want we centers the that very increasing has which So smaller and SENTINEL is manufacturing is the supply, think clinical

a a other more in benefits clinical the likely with increased about talked for And LOTUS you rate all are win efficacy and have we second interventional outside platform SENTINEL, SENTINEL, as grow little safety approved. on of in some to U.S. continue about supply, components which with half products meet will launch LOTUS, it compelling, of views unmute, excited And our like the that to we as bit getting cardiologist. the it. we a like Safari faster Ian at the But the past, the we really and wire then the provide if so upcoming standalone the and given maybe could our have And surrounding the And TAVR are you needs data. other

Ian Meredith

the question. Rick Thanks thanks for very much, Mike, and

quickly. trial XXX is which that for provide very that in platform NASH study, So will there disease. alluded to, efficacy and trial U.S., have nested the IV patients, underway as in with data It's Edge to REPRIE study, we intermediate single arm valve That the the you now intermediary registry and study, pretty important bicuspid patients safety is patients. the recruit a of within risk LOTUS should a is XXX the

year. results we so look those that mid next And very much probably forward to be

in initial continues and at As the underway. have have getting experience we recruit. patients course, which registry, be which sites to And well that as of the underway trials in is XX trial, III with just U.S. the was Edge, we Edge Europe, REPRISE respond which XXX LOTUS

next Edge and data the day the confirming XX from actually results efficacy as seen So the of significant year the end showed from original REPRISE, that of LOTUS year, course, should about the the good pacemaker and we you safety lower - trials, on Edge and (Ph) towards A] data which know have rates. [FIMS we've very

Operator

question next is of ahead. from SunTrust. (Ph) Nadal] And line Please go [Bruce of

Unidentified Analyst

forever have for is follow-up. merits question, have Good to vascular be seem - about it CRT morning. secondly I product coherent Thanks that of that what really of then really whole changes caused I of man the the and a just mechanism analysis in the attended action. I a might family irrespective for was I meeting I and the thing thoughts January, wondering didn't think, for really didn't and panel your Ian, this and Paclitaxel taking arguments guess February Mike the the or

Ian Meredith

take Mike, you I it if upon? happy are

Michael Mahoney

Sure.

Ian Meredith

Bruce. thanks, So

after XX,XXX an trials. in mortality in a the say it's have a question. the to where Sirtex there And know history think randomized than were XX more patients at never know pretty had coronary as you an years. has extraordinary disappointing of all and there I in It’s from XXXX registries, patients even five So really taxes was XX important course Paclitaxel year still trial data approval. we circulation body an data since there their the signal you

and from for stent cause was cardiovascular to mortality just related suggesting time-to-time be signal wasn't to there a non-cardiac a explanation. there overall doesn't So seem plausible the it but mortality thrombosis,

at disappointing, confidence analyze thoroughly is considerable it So the to NAMSA but and work we that out VIVA Paclitaxel in sense is that I we here controlled the Eluvia used product relief as have signal and antirestenotic in XXX the in trials. very still in is a agent., the focal being products. think any that very sure alongside a we DCB assiduously make But available FDA dose point will differentiated the should and we

work FDA, So we we the elucidate and this. have in site and to NAMSA will alongside this VIVA

Unidentified Analyst

or stated product opportunity. marketing is WATCHMAN, initiatives? talk about the of really And commercial given has the think a very take huge momentum either what strong potential the the what clearly of and Just just my follow-up continued I is guess the Could product reimbursement guidance. for I will factors, you unlock play kind

Michael Mahoney

platform, point, Eluvia a the in superior think class. we think just different it's is just we to again, Yes, Sure. Ian's reinforce

the a continues the on we with extremely outcomes. the we it's WATCHMAN, more about It's lot hospitals. awareness efforts increasing platform, the that it's because In are digital spend in opening so many through working our regard. point up, unique pushing device, we we Ian are coordinators will the said, about the for case be upcoming driving in the it well. that. this centers U.S., making theme, that And we new are industry supporting like obviously, a feel been physician to the and characteristics now its It's But whole opened our up U.S., And Paclitaxel all On rates. do increasing utilization, we great with on through WATCHMAN so in increasing less at have the panel. utilization

do are continuing big then, in organization which see not the share, progress to some as clinical in efforts excited with And in organization. Flex half be commercial And really in second WATCHMAN we we of really WATCHMAN you the our Option WATCHEMAN the which we China. maybe trial? of the are are lot market excited the are our And about you to clinical will also want Japan. Europe, with about so market And seeing a to utilization impact speak launched expand Ken, but to gain launch, Europe, extend

Kenneth Stein

Yes, think thanks, mention step, indication unlocks right, that Mike. the What unlocks That I Bruce. it, is, important next to is it expansion.

will patients to device. who change WATCHMAN be the centers so randomized candidates this called have know would prevention. where trial for WATCHMAN indications globally. indication, be atrial or following ablation, patient anticoagulant XXXX a are either would this Option, trial And launching at or are who the And you XXX NOAC. oral roughly used first stroke WATCHMAN we And will trial patients in is the And trial the be fibrillation in randomized an explicitly for

Michael Mahoney

Thanks Bruce.

Operator

of line from go Jason the Mills, Canaccord is Genuity. question Next ahead. Please

Jason Mills

Hi, I profile given seems generate I And to not strong respect organic that BTG, the expectations out for the to half yet. haven't growth in premise laid Mike, will into as next the of But that the digest year recently. the to give appreciate are can are year, guidance you that that ready first assume you laid would your the acceleration their year. out the the taking metrics we question. with respect next end with you tenants of like growth results for coupled you BTG that, anticipating changed organic continue of through With thanks they the for

could it give or where that we it half us beyond year, getting you a this of willing color XX further color any at forward accelerate to So related Can like first like up as is next setting I'm just the in it year end you further. look to could to any give what it as of the seems at this us XX accelerate months. it's seems

Michael Mahoney

the point Dan launches rattled in quarter. clearly of second activities. and especially let the want he will the the sales little this quarter first second to momentum XXXX here But, not after through that we our why script guidance. anniversary in his on are you M&A off in XXXX give product miss the at confident I me first quarter laid out half

grower supply challenges I'm in less second Another than of going new we acceleration. That XXXX. of Japan. will key product in Dan that are significantly quarters you not has our to the be are half in XXXX But a launches, these see full-year XXXX products. be past, better to significant And Japan future for comment acquired we are of second benefit the different to nice selling happening year revenue launches growth. throughout many growth different is what and day. cuts excited And experienced opportunity very is in pricing the Tier half half in much of mentioned that, continued And beyond of really to with to in because consistent also us the double-digit BTG, then results, about a the would second is those they put our the really when EPS return and have Top will company. the some deliver the a up in goal product we thesis strong kind

to the look June, in closing late we timeframe. that forward July So likely

Operator

ahead. Please go And Wells line is Fargo. Larry the next question of Biegelsen, from

Larry Biegelsen

a well. hopefully go your heard understand, But as go the in ability just the But market. is implied But business Hey, well know, and the Company I a guess thanks question. go things offset things guidance. SCS in report is panel your your taking what will as I the have, you reduction growth. ask guys, deceleration I expected for and will in Eluvia both the mine I comment meaningful can XX% of I the And upfront. on further cut don't second in look, on Secondly, don't question then are well. Eluvia, if if the to you SCS to

Thanks just grew what questions, for in of gave the is QX. that bit you in the in guys. on going you more confident you could year-over-year taking market around which are why kind So deceleration X% on the further put the see a in bone SCS, about today, meat slides little we and kindly won't

Michael Mahoney

Yes.

we growth clearly aren't it, customers So are it. the And up U.S. an for to continue on Eluvia many giving because And a is good driver we PI. seeing use patients. think in product uniquely that important it's helps we

now. essentially we have are not, in Japan, are. launching, And Some but many right

also That is So smart. also in is we remain of PI within us business take on but growth for its drivers the impact. Eluvia that saw down why optimistic, there many But guidance you own. terms

both second will likely For revenue we full that launching example, this and BTG new in the come all that once quarter with be FDA stent the approved impact Vici the the and synergies of cost. and

So, as do within gave, drivers is or guidance Eluvia for across give we But growth that XXXX. very PI guidance half clearly outlook that and confidence - second us Company the a well there many full-year well. the to want we that as for we

first the be traditionally quarter, double-digit growth will The second case softer we question strong a and the we a that although was was bit a than is, yes. believe It anticipated in first this bit quarter been market, softer.

wave ramping months, past six So second large riders clinical this seen unmet out I somatic and we SCS be competitors where possibility that quarter, from product the fewer our see and there. reasons from softer half the see any bit us the this year enhancements potential you think on data. some demand that this to given of launches haven't a patient kind of why over to will more BSC of up new should with One - we clearly

really this it's need. market, likely, great And continue growth don't minimum more at one will like we given then a to a of So but importantly, patients a response. have to long-term, patient think growth, is unmet lot innovation act. excite we in I double-digit feel And this which space, the high single-digit

Operator

of And you. line Kumar, Evercore. ahead. from next Thank question the Vijay Please go

Vijay Kumar

Hey, my for thanks guys, question. taking

first in versus think on I just, do chance a in plant what half half? fact maybe Sterigenics guess specifically, there the Eluvia is the the closure, back cut right improved, Mike, the second to And QX I I needs goes Adcom Larry's know it So guess is maybe If of questions. sterilization was? that, for if the again, half, be about back, we impact

Michael Mahoney

things. guidance gave we assuming Well, bad

panel, we gave what for to conservative, our we very in very So, wouldn't be we on do based built that Paclitaxel growth conservative otherwise. felt the Eluvia model responsible

our planned customers So, full-year that are use But as I assumed we've launch far seeing are we we today. the than sales second it less Japan, in Eluvia quarter seeing mentioned, and in guidance.

Vijay Kumar

Thank you.

Michael Mahoney

the not quarter. specifics going issue are in to we And in health the sterilization of the quantify Men’s

Operator

Please Thank from you. Matt next UBS. question go ahead. Taylor, is The

Matthew Taylor

seeing each it you with Sentinel sounds can characterize sort Hi wanted it I of uptake? think to thanks timelines for the question LOTUS part you on to should taking are are on the beginning just and but in in for be you that year, the earlier you sort sell to And region. follow-up Europe, wanted two then the and to thought didn't how hit wanted pace where question. can of launch thing, understand in how where would about of still I the the you the the a of the just on-track improve through the in supply year. you like launch sure good of we U.S. timing the make you launch

Michael Mahoney

Yes.

previous given the selling we be versus in likely higher customers that there. that who Europe, in the well our So consistent But and there want are to we LOTUS, selling LOTUS are LOTUS LOTUS, have momentum Europe. in with comments you mix extremely valve are also with Europe, are on we see ACURATE ACURATE going valve many

places. So both terms in out, a But it quite mix, we be be sell higher won't bit in able U.S. break Europe. which will a to the in of likely versus

important approval more but great team been centers. simply why is supply, kind we've for commitments, has waiting of so for ability done just this see the in unscheduled Ops And will to limited up FDAs our in our a us. SENTINEL that new is you enhancing greater open U.S. the It's because And of job

expand it able be And given and on, supply centers in it haven't will some the more supply And and benefit second it. and as to we them will quite open quarter other then this capacity. using countries, of so up be goes with had frankly, new which half Europe

not it's in wrong. Ops the nothing bought company our team significant there small it. for - simply are So increase and They now a capacity did

Operator

from the Chris is question of next Please Guggenheim. Pasquale, you, Thank go line ahead.

The dropped. from ahead. go question the Please SVB that in-line Catenacci, next Okay, Daniel of is question Leerink.

Daniel Catenacci

good so taking Hey, morning. for guys, Thanks much questions. the

you pricing in perspective are LOTUS see what now what the expect Just of relaunched that U.S. talk seeing been Can a from a quick having. question about you conversation TAVR - follow-up on have and some Europe, you you the to in you

now in So a it’s player four to potentially you going market, from player player three the a here are market since two U.S. market

we give some plan level of Thanks to your to color in so thoughts and So get high love on U.S. to you relative can how just here your competitors. the price much. Edge any LOTUS you

Michael Mahoney

Yes.

much as We you are on probably not going a want to as give question.

race U.S. offering I so in a U.S., is you competitive with market and valve confident think, segment very the we at the capabilities LOTUS LOTUS that in This low will are priced of not see a tier

Daniel Catenacci

to just follow-up that. And on

is Europe in it well or priced competitively priced it a discount? is as So at

Michael Mahoney

much won’t provide thought we Well, there.

two Europe. Now with LOTUS offer we valves in different

and And does the so valve helpful, are benefits. are contracting uniquely us of SENTINEL its it need the end in on to the the capabilities clinical efficacy, the terms but stand the both they day, which good safety at alone provides and some of

doctors know, money. going typically aren't costs tidy less because You a it choose valve just

a very you also we ACURATE, data And and delivering there so lot seen clinical have with outcomes good are of LOTUS.

important, but a is to obviously drug-eluting pricing environment it's different So stent.

Operator

Piper is Thank next question Jaffray. Please O'Brian, from you. Matthew ahead. The go

Unidentified Analyst

with back marketing SENTINEL real LOTUS kind you the share have and that which questions. you said In XX% off Two quick is Thanks of now the for taking morning. side, you Good in then you TAVR here. the differentiated. pretty withdrawal get past and the

about share can think of launch think now, Paclitaxel about are Where for back second over this think now triple year commentary time with you as much. get is share should you how it. expectations specifically to would go can can you revisit? about just do by the And we be So XX%? with kind we should think threat you And do our think on that to you Ranger, to? you then all where question next Thanks as launch the so the get like just

Michael Mahoney

businesses again, historically on for panel Is certainly Ranger. But Right And Europe. potential think with blessed get Yes, a And all many in board. think it's in have now upside. the smaller so growth contributor U.S. Ranger. the influence across zero the We revenue drivers wouldn't closing. I then on we PI BTG Ranger will the our comment just also with share. an will - I

uniqueness indication commercial the And expansions, data like area, in of publically. share clinical this of job we've and our feel a but goal a can going provide of are to breaths market, this LOTUS the so you do we know, the seen not and nice size with in the We we and coverage.

Susan Lisa

With we us Alright. your appreciate would we like in joining to conclude that, Thanks call. the interest today, for BSX.

prudent Before give you disconnect, the Kevin all the details to replay. you will

Operator

call gentlemen replay. midnight. XX:XX starting And and today am. Xth May that this at conference for be Eastern will is available through run and Ladies you. Time, will Thank

code by Services the AT&T callers You the X-XXX-XXX-XXXX dial XXXXXX. access code area the access Playback may XXXXXX. XXX-XXX-XXXX with with code may dial Executive International dialing

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Boston Scientific (BSX) 24 Apr 192019 Q1 Earnings call transcript