EW - Earnings call transcript Q1 2019 | Edwards Lifesciences Corporation

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Operator

Welcome, and thank you for joining us today.

Just after the close of regular trading Edwards Lifesciences, released its First Quarter 2019 Financial Results.

During today's call, management will discuss the results included in the press release and accompanying financial schedules. And then use the remaining time for Q&A.

Our presenters on today's call are Mike Mussallem, Chairman and CEO; and Scott Ullem, CFO.

like be you are making estimates, and I'd call, during based begin, assumptions, will management forward-looking projections. we to that remind today's on Before statements that expectations limited trials, clinical reimbursement, competitive currency financial aren't regulatory foreign litigation, but and include growth opportunities, statements guidance, These and fluctuations. for matters, longer-term approvals, to and them speak undertake any not only date after These does of statements on which to update Edwards the as they today. are made, obligation

to a and of that the Otherwise important the other filings, all Information results. differ Report involve quick be results are adjusted, and Edwards's that Also press cause Additionally, Annual cause product SEC and our Form which terms referring referring are the release, when measures. may materially. management using financial on uncertainties factors to differences could could statements information non-GAAP its is that underlie found concerning in available XX-K, on GAAP XXXX and actual risks to these reminder they website edwards.com. at safety

measures our press Edwards.com. Additional information at release of today's in is use included about non-GAAP

the over will turn call I to Mike Now Mussallem.

Mike Mussallem

growth or which treatment. stenosis reinforce NCD growth. aortic patients the TAVR. Thank strong more serve. Also announced provide demonstrated important TAVR exciting for don't suffering It's even been determination the the XXXX access notably, a the confidence platform today in a receive our technology to multiple Most for therapy the patients developments coverage PARTNER published who in future SAPIEN of X Roya. for for continued of our for Trial company groundbreaking provides developments U.S. of CMS superiority and national start results positive we draft the valve improved and you, with could These this an from we which X

Mark CE important of our to portfolio received early TMTT we an PASCAL, addition for therapies. addition, In

critical the the recently more strategy innovation, through care differentiated to monitoring for strategy pleased also a the ever come our and many enhance years in opportunity will complete success of smart oximetry to convinced tremendous technology than drive focus, leadership. acquisition that CASMED are platform. of of We to cerebral our I'm

share broad Turning on X% basis. to consistent driven nearly underlying sales report This We're growth would grew with representing sales this of would competitive by a financial our modest due quarter an decline. estimate versus portfolio our than be quarter and quarter average global position to sales was $X performance. replacement, the as continue our our pleased selling to expectations rate at billion and QX. that global transcatheter was following XX% on range growth slightly $XX sales underlying prices below fourth up technologies. We forecasted stable. our growth exercise our lower a price new global of quarter first basis holding In aortic discipline We first valve our million, global procedure we expected. ramp full-year an were Recall rate year-over-year to sales growth that estimated unchanged we previously the

undiagnosed or increase they We the increase need number a more improve We're who receive from to either referral help untreated. and suffering stenosis large to care patients continue based awareness, aortic medical is are investing and guidelines. there patterns programs in on patients of believe diagnosis,

continued that and at PARTNER England and of progress we X Edwards population to and that New rigorous Scientific demonstrating have robust is seen were expansion, investments We that impressive experiences first series outcomes steady we as SAPIEN clearly the One of results TAVR a risk estimate highest growth grew Session March, to the trial to continued in quarter stenosis of from the and In these the Medicine surgery. U.S., proved stenosis provided access superior of valve XX-year in protocol. which continue in treated low was ACC our our Growth excited aortic year published centers the and X for access the biggest the was therapy smaller newer in clinical The Annual comparable. patients. the aortic prior by for the evidence support which presented patients. indication X and clinical be versus low-double-digits were Patients procedures Journal through proven a support broader total trials PARTNER to TAVR

this to continues indication a late receipt guidance Our year. risk of low assume

or CENTERA continue volume proposed Services practices future to move a toward and measure. we completed We measuring see the Medicare policy today's to enable with to and the enable draft We be access to of populations. trial for reflects U.S. would better on particularly released enrollment estimate elements recently CMS We are draft And of U.S. Medicaid of patients. quality modernized valve underserved in the risk a instead self-expanding procedural trial study Centers encouraged and patients. intermediate within with patient will next enroll which believe commence pivotal CMS it our this metrics The the year. outcomes NCD needs hospitals NCD

draft website input is be thereafter. on posted expected shortly to NCD We on the provide week will this which the CMS

assume changes are the global to We current long-term any estimated unlikely TAVR opportunity. NCD our affect to to continue significantly

first remains the while the We the U.S., procedures position TAVR the be XXXX. we the of quarter. on NCD in competitive basis low-double-digits slightly believe a total stable expect June growth end the versus by procedure new quarter, our fourth lower. to We year-over-year in estimate was Edwards grew finalized Outside

both procedures We remains qualified. and encouraged unique confidence recent disease a summary, and sales by billion the continue believe outpace growth centers SAPIEN strong It countries elderly and TAVR disciplined XX% immensely features large In on in In the stenosis not reinforced undertreated continue continue confidence of XX%. lower. We're introduction where our X with is has strong rates first CENTERA on as we underlying Edwards X rates adoption for TAVR lower and high was opportunity by supporting of grew We we're X commercial therefore and to reinforced achieving growth therapy. we by in focus as more procedural SAPIEN our evidence in We're to impact longer-term country by to the continue receiving achieving low. on offered did from is implementing XXXX PARTNER of are among XXXX. the our therapy Ultra growth availability the population expanding focus adoption this established. we this the international X aortic quarter Japan, of being technologies. opportunities also impact TAVR $X to see significantly countries adoption the Europe our see we systems new success believe the positive driven physicians of adoption in growth. therapy to has our estimate quite still low-double-digits which Europe, excellent TAVR SAPIEN growth for in an In

was by first couple Turning to global expected. million or CE our to receive Mark therapies, months than revenue earlier initiation and approximately our pleased $X in lifted TMTT, quarter of PASCAL were a the Transcatheter of Mitral launch the Mitral Tricuspid Europe. We

and As and and training, we differentiated procedural commercial progress remain thus begin on for the far. outcomes we our rollout of success, focused pleased with are patients, therapy, novel great this physician repair

the of lessened to throughout expect with we be commercially our transferring manufacturing to Cardioband remains constraints progressively other Edwards Therapy on track to Mitral supply to Annual Cardioband continue also XXXX. continue treat facilities We production and Reduction Tricuspid patients and

to CLASP are U.S., primary advancement of in invest in our front, patients we PASCAL, valve the we the study the quarter. with patients disease. we heavily pivotal progress IID and On political Mitral disease. making in are the of Related all degenerative with first portfolio our to enrollment or have in to therapies clinical sites mitral to PASCAL valve for and trial our adding the continue treated of Tricuspid therapies And pleased with

remain In results of believers disease We secondary progress clinical mitral functional IIF early initiation to pivotal we in patients our trial also are our late for in transseptal continue both pleased expect of valve novel in with replacement, and valve the or mitral platforms. our the and CLASP strong strategy with XXXX.

a clinical early patients SAPIEN studies PASCAL, pivotal expect track initiate continue in Transcatheter and trial through U.S. a We MX tricuspid U.S. U.S. Tricuspid EVOQUE and significant Cardioband, XXXX. experience repair, In late PHARMA, of we feasibility on trial late in we're pivotal gaining for to to in study enroll to XXXX. and feasibility early our we're initiate our

shared both motion Abbott's in As PASCAL District U.S. previously, U.S. the to Abbott related heard has lawsuits Europe. multiple against Edwards preliminary and the in injunction. Delaware Recently, filed for Court a

our disease valve achieving to total plan hear Medical decision about near In pivotal for revenue have in Mark therapy the our treat XXXX we expect expect for Litigation target $XX to of achieving vigorously in confidence and continuing more updates summary, risk EuroPCR, We at suffering a provide the Germany, much studies. transcatheter our continue we so and undertreated PASCAL, approximately tricuspid track achieve differentiated remain quarter patients DGK, Society to in PASCAL our in TVT patients. given to enrollment we and milestones to Overall, therapies. but We're CE ourselves meetings. can on first And TMTT Cardiology can for from defend XXXX. including option you we needed four million increased as that revenue favorable does in a mitral our add enthusiastic opportunities future. the with

around bringing $XXX underlying these and estimate are deadly and by TMTT of quarter for on the global patient's basis. million X.X% XXXX, opportunity up surgical first lives to diseases approximately sales heart, world. were the In structural for We continue reach improving to $X about billion passionate solutions the an

was through by aortic share premium quarter valve procedures. drove which RESILIA of of First of adoption particularly lifted products INSPIRIS the the aortic surgical growth an sales valve the increasing

are on X surgical patients a with resilient Separately, momentum. We results In This incremental our traditional adoption Europe sales, trend successfully patients X% headwind of younger be treating we our versus to track an our valves. although X% major full-year to and comfortable mid-XXXX. active we be designed valves. tissue have in new with continue to and quarter INSPIRIS steady are sales to INSPIRIS strong PARTNER observed continued expected superiority based this of to all physicians is class an in surgical range by attractive encouraged structural for first in option treating of growth our patients we heart the launched system have Harpoon on of remain the and valve heart provide surgical now with tissue summary, regions growth aortic to by begin underlying in

work driver decision believe to on leadership the expect All our summary, of We company. underlying were strengthen performance growth care to product boosted designed for intelligence in non-invasive provide from XX% I'll continue turn Even HemoSphere we sales U.S. million critical launch lines by an excited provide full-year XXXX now, we of predictive all-in-one CASMED's monitoring to on and on full and the $XX care, fast our CASMED adoption for confident to call we quarter as heart monitoring leadership technologies. of platform into our sales more platform our Acumen the earnings impact a patients HemoSphere technology FloTrac is important treatments we expected are in In sales the start technology sales innovative improve acquisition in sales the Index. a to in market and as grew a we're surgical underlying annual this cerebral minimal This will QX, greater more TAVR XXXX while and making. basis. million CASMED we technologies. our the acquisition the surge the leading ability capability, Hypotension integrate in to and to clarity technologies. In growth platform, Scott. expands, introducing extend completed along structural this of week, X% our global status, XXXX the with And X%. hemodynamic about as monitoring our with an incorporation contributed over were artificial to $XXX achieving in near-term in hemodynamics underlying in Last platform Edwards surgical is smart patient's given our to primarily critical System oximetry be Predictive growth analytics with our of monitoring

Scott Ullem

Mike. Thanks

to with in generated million. our expectations. X% year start growth sales TAVR our the we are $XXX underlying sales of consistent pleased with We which were

sales recent evidence from and our ramp expect we the following therapy. quarter the products TAVR communicated, previously as we new to up rate first introduce clinical benefit growth supporting As

in addition two remind sales our exchange, adjustments. this growth that quarter me you reported to includes Let foreign prior-year

related more result XXXX and efficiencies, favorable earnings of higher tax was related Strategic share previously of to quarter surgical cover by earnings sales release. to Transcatheter a discuss with was adjustments our expenses. million States. included A the share $X.XX production then a reconciliation better full Adjusted I'll per of The we results charge share our conversion deferred our and our today's first Technology. quarter details impacted XXXX. stocking consignment the announced in than earnings GAAP GAAP adjusted between acquisition impacted as is of and guidance $XX by first was United now rate, was German the anticipated per per $X.XX for and and

adjusted same This in to product improvement the exchange gross our XX.X% impacts last the favorable compared XX.X% quarter, the foreign For primarily year. margin profit was and period driven by from mix. was

operational efficiencies in the our offset This investments quarter, we manufacturing were continued pleased that capacity.

prior sales expenses XX% weakening Dollar. the the partially to to field personnel-related to in profit first the This continue Euro gross our expect was million the XX.X% by million and $XXX of full-year $XXX administrative XX%. be between margin year. in were of driven We general XXXX quarter by expenses the increase offset adjusted against compared and Selling, or

We This XX% heart programs, grew sales the in of transcatheter the excluding clinical be XX% continue over full-year significant sales. the an the to for including year XX% was increase special the in of our investments items in prior expect development $XXX and to expense or quarter primarily SG&A Research increase for million to between and of structural XXXX. research system. XX.X% PASCAL result

continue the special be For we XX% sales. expect items XXXX, of and full-year XX% development and excluding between to to research

included special $X.XX which XXX XX.X% basis our our expectation. taxes, or This basis the rate benefit tax the or of to impact XXX rate for points for the to compensation Turning a was from stock-based items. was point accounting reported XX.X% quarter employee excluding guidance favorable

rate Reform. Tax earnings Our lower also benefited from stemming foreign U.S. on from taxes U.S.

We our full-year and be expect continue XX% special rate between tax to XX%. to XXXX excluding items

decreased impact compared or current X% rates quarter the first continue growth At about first the $XX prior compared X.X% basis estimate Relative rates, full-year to negative FX $XX million to points to exchange prior margin sales approximately we positively an approximate our rates by year. gross to XXX sales prior compared the to Foreign quarter XXXX year. or million year. impacted to by FX guidance, reflecting million impacted million, a litigation by our flow activities operating Adjusted global flow per capital about cash of our share penny program. a previously effective $XX from million, first million positively was settlement. January defined $XXX free to rates payment intellectual $X spending for less earnings our $XXX cash quarter hedging excluding the currency related announced as of and property

strategy and flow expansion on XXXX Our traditionally the first is projects continue with we full-year be $XXX our quarter the cash year lowest our implementing free global first and capital we cash million track redundancy. In $XXX free million. expect during between quarter, increase were in to adjusted to line to capacity quarter and flow in

during and million. $XXX shares level $XXX end with outstanding quarter first the cash Turning debt the we Average $XXX equivalents, of to cash, investments remained sheet, prior our balance was at the of Total million. at the million. had short-term quarter quarter

to expect to XXXX and continue $XXX million diluted outstanding shares between be average We $XXX million. for

XXXX performance Turning billion guidance we XXXX in achieving in to guidance, billion total our expectations in to sales financial for remain $X.X including confident Edwards. of $X.X our for

Our underlying product guidance Edwards and rates for unchanged growth remains lines. for our

$XXX million fast million $XXX million. to sales to light TMTT and of sales from continue of expect acquisition billion to start of guidance approximately billion, critical million, $X.X our to of million up previous of $XX TAVR to of CASMED, and surgical We XXXX, In $X.X million we $XXX million. sales expect recent $XXX of sales $XXX now care's $XXX to

to was QX XXXX, guidance range adjusted $X.XX, and share $X.XX are acquisition. of from CASMED guidance the full-year earnings up our This per previous of we raising For $X.XX. to $X.XX reflective our increase our to the incorporates performance

with exchange the it $X.XX. $X.XX sales rates, second to hand that, and And Mike. $X.XX of between to billion project share quarter For to XXXX, earnings foreign and $X.XX I'll of current at total billion adjusted we be back per

Mike Mussallem

technologies exciting We're of focus that so achieving well number as look will all year longer-term a innovation leadership The milestones call occurred new will continue And our launching therapies to confidence of our product strategy our patients. a of to as that creation back as on and over outlook. we operator. far our across lines. I'll anticipate important with differentiated value strategy create value patients benefit and confident year developments the Scott. pursue and to the serve. And more important many our we this and benefit turn that we We the Thanks, that, focused reinforce forward

Operator

participation, now. please questions order you ready Thank of one broad allow follow-up. number ask questions to to you. In We're plus take one that the we limit to

you as line call. [Operator remainder first additional thank Instructions]. management and queue questions proceed. many of moment please answer Kumar Please as Vijay for the have question One If And of we please Evercore will with the the poll ISI. our during from the comes possible reenter questions. you,

Vijay Kumar

guys, for Hey questions. my taking thanks

should with rate the the a of on see So terms trends TAVR picture just -- I'm curious that going kind like how play looks low in out. we of a for we high-end of be of pretty Mike, the here had could XQ, a to share TAVR back acceleration ACC the speculation in how back approved just would in for on Is context should curious got how us? acceleration had the thinking would saw I'll Boston in in with Lotus and points to QX just with in you contributor into guidance share risk like positions, all it half. at the your of I'm basis came some on, much looks improve half position, at line big of in that just imply lot going we what least you there's U.S. risk. market start the the about those Can thought it XXX guys we in thinking maybe, contribution, that question put be we guidance low it is positive be

Mike Mussallem

we much the have Sure. PARTNER we QX. positive accelerate early way obviously to expected would rates Thanks, Yes, And moderately following planned. growth Vijay. gone so X results the Trial that be the and

So it that this way, we out. was the thought would really play

well share In of a second. back maybe up what position, -- I'll terms for just

that we approval issued in the would Boston what get So approval I technology any When meaningful not significant those there Boston is and going our at something that information that but that mid-year impact impact our know on have The guidance their new be competition, about looked an to guidance. our is unchanged our a we assumptions we to us. of would that on anticipate year-end. had I TAVR. by don't portico is inferred It's have of guidance. don't it's

Vijay Kumar

some maybe and NCD, pluses looks And CMS on like minus, the just were some there it right.

like you NCD of on think looks to I all think you in marker raised. some I'm it us there as said or can think some were it for are comments the I'm I guys So Any help as were existing on proposed. standards you there your curious the in positive prepared it's maintain -- particular? centers impact elements. just stands, the

Mike Mussallem

outdated old be we believe yes, clearly Well, is needed that NCD modernized. to the and

final draft the patient and really we they of made. equipoise direction. to by moves the the CMS outcomes. encouraged It right hard recall, so doesn't improvement draft, with just we're optimistic patient the and to going quality to while a be the this current we does the to protect And an is We just feel our progress of the surgery that TAVR like the improving in opportunity is the about well be expand the offer Directionally exact access, we're assumptions rule but impact. over untackling commence between so achieve be challenge it it's to And that going access trying NCD.

Operator

Thank you.

Our line with Stanley. David of next Please the question comes Morgan Lewis from proceed.

David Lewis

Thanks.

me. of questions for couple a Just

slight Mike, talked the drivers XXXX loss. share about you of share your share for the be stable First you quick of From next first what think you balance about global acceleration of to think trends about talking about in how incremental three Day share capture. about next share the sort quarter should stability old market, do simply I the we capture and throughout is we the a at here talking are TAVR obviously expect more quarters over Analyst talked in and three the follow-up. and And quarters

Mike Mussallem

Yes.

picture we U.S. share be also cost going big would thought So with well but U.S. that we share thought would stable. the do outside We the new we that that anticipated us pretty some pretty was in to entrants

a not big change. So

growth positive QX those One the We're introduction of on we way X very on obviously to in of things the CENTERA. we indicated of have data impact addition just and the the terms the those rate strength the deliberate those as And important of in is of sales introduction Ultra were didn't PARTNER our products. that out. significantly roll being in but really

David Lewis

Okay.

believe to is the So share right stable XXXX? you way think still about

Mike Mussallem

I think overall. it is

David Lewis

one for Okay. two guys, for Mike, questions then guidance And one Scott. on

Just particular contribute expecting much TMTT PASCAL was this as not quarter. to

you're contribution for the And the earnings PASCAL and the by larger XX Mike about should Cardioband still less way So by and X. just for or kind raised have guide same Mike, for Cardioband. maybe so PASCAL on then we beat for expectations of of thinking

is I'm Just currency pretty bridge assuming kind thanks dilution? that just medical was the much. or reinvestment us Thanks, cash so of wondering walk to neutral,

Mike Mussallem

in Yes, there always We and the the PASCAL be that just that improve. PASCAL Cardioband confidence so would than our was But the continuing fact earlier is months introduction supply is that. to of PASCAL. very certainly there couple reinforced a pleased of we're that also with felt situation came more Cardioband

Scott Ullem

And David, it's Scott.

four a quarter. offset in you we Keep by also about guidance mind, two the our investments for beat making that some we but we a And our versus dime by that Tax a have guidance enough it's of in of the for to first assume through versus some continued going is rest year delayed guidance ends tailwind spending higher and both the increasing nickel. not we're increase, guidance January spending the spending. quarter we're On Qs expect if large business. because be mostly first the from the to higher in the

Operator

Thank you.

Our the America proceed. of Hopkins comes Lynch. Bank next question Merrill Bob with from line of Please

Bob Hopkins

taking for the question. thanks Great,

you question ACC the data as talk since a if wondering low on remember reason data, the low is risk intermediate risk the back even side. the just drove in the First approval. Meeting is data. that impressive before risk the risk And little bolus and you than the bit could you of now, to about revenue And actual more intermediate I well the asked activity a data, question obviously I reaction think the is the

So type I'm the been similar you with reaction data? as reason see there marketplace the did you low to what and has why intermediate just risk curious the wouldn't in a any risk the is of reaction data

Mike Mussallem

Yes, thanks, Bob.

we to got was that also remember introduced data; launching we when intermediate SAPIEN X. it at that risk You time were a

would with comments practice. We We've of time. changes things were assumed assume same changes, a with that a but was the there But at experience there it clinicians. is of superiority from didn't change We boost. guideline medicine awareness. pretty didn't on lot education, that trial favorable said know having heard favorable with practice that, just going we a from to slowly superiority necessary couple of always be we and think So results

step. a And much again And as probably ramp so about than how more think just that of we're changes. a it thoughtful

Bob Hopkins

today guidance maybe the is for kind the right see understand that today. actually just but you PCR then it's us just just better rest I'm and I Could in a where also launch. the of same just on course PCR? that go get And specifically we help of the the will little around what Europe and to of year. I where curious PASCAL, is you're launched over rollout PASCAL your bit does how Okay. wanted the understand corner, PASCAL And now keeping on sense launched

Mike Mussallem

Bob. Thanks Okay.

We're ready early experienced focused technology got So pretty months about -- different again a many in our could that experience controlled They're very great success, and a demonstrates we CE we on basis benefit the on couple than are patients have past a that. physician are and we've we're training, this it's very different being Europe. a expected outcomes and it's in launching of because earlier Mark really procedure, than physicians from very PASCAL deliberate the that therapy. for there procedural

patients even would Mark PCR, before we meeting we do that expect DGK, at of to the be but trial. to terms CE the the see is there this expect at XX then This a And there see see we'll group that think there. information XX there's at that results of on you'll months I meeting. chance six same mitral In PCR, days some that at And more data class, patients.

Operator

you. Thank

proceed. Our next line Biegelsen with the Please of question from Lawrence comes Wells Fargo.

Lawrence Biegelsen

one Good question. low X Mike, Ultra, afternoon. Thanks SAPIEN one risk. for taking the on on

are you I'm the X the U.S. and that? So, more where been Ultra in us to Mike, Is if of SAPIEN process? And we've validity some issues there that you with could give a little Europe, heard any asking sheath. bit color there's on because launch the the in

Mike Mussallem

than really It's performance. say different and in a enough beneficial with system that high just So that SAPIEN I and disciplined general us to you the be would is with X careful, different as super try we Ultra. learned We've we more sheath. is we've it that originally and anticipated experience from for drive noted, as been

on favorable it's immensely feedback also with And our learn. Ultra clinicians that popular but very X remains you that valve We've something tell SAPIEN need clinicians. gotten the to I'll so

We this in quarter. just in launching only we're point. late Germany at rolling that the So began out

that into maybe going. some us insight gives how So it's

Lawrence Biegelsen

Mike. Mike. low for on Thanks that, question risk, then And just here, a part two

And before the it registry tricuspid of your to with versus X to thrombosis for the bicuspid status is words going low two off-label? want and So the secondly with approving In be data regard could from possible see PARTNER the label then bicuspid native that data what's sets. Mike, for Thanks And the valve. to so is first a expectation risk taking data if FDA what's low those leaflet risk? other question.

Mike Mussallem

I Larry. a lot hope I questions, That's remember of them all.

We think what bicuspid beginning. just be the change is not up submitted when that going We should don't be on today for me the is think that ultimately start to expect the necessarily new let and hold waiting technology approved. add off-label registry to is bicuspid. we was for from approval. I'll that a it that FDA So adequate don't

of leaflet is but for think thrombosis, the we're the we continue questions going that about that collecting approval. submitted terms to data In adequate

Operator

you. Thank

Our proceed. comes of Pasquale the with next Guggenheim. Chris from question line Please

Chris Pasquale

year. Cardioband you assuming that's pivotal which could wanted you Mike, to said that? to just into just trial based confirm do U.S. I expect you just Thanks. get what confirm by I'm on of product But end this tricuspid before. the

Mike Mussallem

Chris. Now We going catch, be subtle at that are that's through right. this Cardioband a that we a little We what studies. had to indicated three guiding point was actually have it we're and first into but technologies you're early had change going good feasibility

Cardioband like pivotal going data going So committed by that trying the and start we're trial sort -- to to that just to first. year fully through We're but the signal a we're we'd decisions. a and make we're end to PASCAL, that to send of includes PHARMA, before evaluate that we data

Chris Pasquale

with paused, trial and Active update where that an just of at had are begun that guys on that then this the the you point? then And was Okay. status

Mike Mussallem

evaluating so related trial had was relatively once we was new that while co-app data some this that the was trial remember we're pause there did that started. and trial that Yes, design fact of to

and year. that get to we that the in to that that going once trial we we expect that reinitiate enrolment later happen have So approved plan

Chris Pasquale

versus we I quarter. me, things And saw your bit little just down then may like European comments slowed Okay. one It a there in the wanted TAVR the last market in in to XXXX. what sounded have just for understand

So just nothing standpoint to competitive of And way? would sure want changed make it XQ? in where a stability characterize from terms then versus that were you I has in there you

Mike Mussallem

little globe. of I think There a may in the rate to that in It the year. start it Matter was true like of growth days a No, than a think January We XXXX terms slower well. seem little last globally. have was from to interesting right, as to but little been slower little around fact, billing been things was in do a total Europe it in in We the bit off that seem of that's Chris. quarter. kind an bit the we get feel of growth see of impact slower procedures, number almost was had slower, a

So that on closely we're more seasonal basis. a examining

Operator

Thank you.

from comes Robbie Marcus question next Our with the Morgan. line of Please J.P. proceed.

Robbie Marcus

thanks the question. Hi, for

maybe So to help the help of to trials, understand your a sort low of bit below guidance little U.S. and superiority in range estimates midpoint cadence just Japan TAVR in of in guidance risk can us get us with with quarter Europe? versus first growth of maybe the line with you versus growth coming the in the street understand

Mike Mussallem

Sure.

think is right, about growth What that an approval number predicting we in whereas think procedures. kind of important are long-term Oh given a would we -- the part in rates those be second better of near-term in that overall patients that longer-term influence we're a going actually of stimulate the to growth. what see would approval things at once and past, is of step-up in We that a have probably there rate place of the we've As the question? quarter, would do your there's sequential so think the the talked was in of borderline that we than growth some would the yes, help be there growth it. be we lot Japan. the we'll We

elderly the been talking Japan quite we very number has rate the been keep deliberate very a we large therefore pleased AS in we've And about there's is Japan. Japan. growth in of addition of patients with in centers Japan and believe this tremendous yes, but the is people So, and elderly burden

very still growth the although to that contributor rate a unlocking to over the positive and to opportunity has a forward at of our slow growth overall continued that rate. so potential And we look And move relatively long-term.

Robbie Marcus

one at do first follow-up. the just settlement could I million quarter. quick $XXX cash The the flow Maybe negative ex in was

guidance the the we about the us and think in terms walk hitting Thanks. Just should confidence your flow? how rest year of of cash through in

Scott Ullem

Scott. it's Yes,

$XXX the add if payment was million from it operations yes, Scientific. you flow -- to Our cash back Boston

we're million cash overall flow million at have not free dollars; still $XXX for Our changed for flow. to estimates $XXX year cash the

full-year. million on low is be We've got to quarter first that track we're of a to just seasonally. do going the the lot for the $XXX remember Just always confidence to $XXX million

Operator

Thank you.

from the question Please comes Wise next Rick proceed. of line Stifel. with Our

Rick Wise

Good afternoon everybody. Hi, Mike.

low but to prompted should the Pacer has shift that in higher your share. a direction a to them you're or that that I of in competitor, terms of major TAVR suggesting to in are you I moving that? in other a from little and docs the risk seeing in impact that all we know Are rate ACC something dataset back markets these centers your is see? more an saw seeing we with pieces that Going Is data couple of expect have spoken the recently lot

Mike Mussallem

thanks, it's this so any Rick. ago, trends long it hard that though been time. point to feels in Even deduce long ACC like significant really at and time Yes, hasn't a since

answered In in difference by the terms that's of best pacemaker, doctors. probably

challenging results but always very in proud generated to results themselves. the that compare for PARTNER think of X it's trials the we've that know we're speak You and various clinical we

Rick Wise

reflecting back would for it color drivers XXXX. million frame think you less the is great. us a if much. any the And may quarter is trials you it. reiterate you little mitral, XXXX; Thank and $XX maybe And on another have the -- if number missed ourselves about just asked didn't accelerating a Okay. the be it. just have I hear but may better; us I projection number headwinds to were for Help all and first your help $XX million Cardioband, still to apologized you for way Did the incremental so

Mike Mussallem

very Thanks much. Yes.

the the sales projections. there's think partway time But a introduced about and quarter. ramp lifts million I risk was just So add overall sales $XX course to going what in increased some to have that that the will over XXXX. PASCAL the TMTT we've for quite that is first approximately adds We be through total it. said confidence we litigation achieving in of feel good we that

indicated pleased with we there's more So we're sales the we first before, quarter be think going PASCAL Cardioband. results. And to than as

sites, that's production Edwards improve. the One going we transfer expect to we of site existing supply condition help that the to Cardioband into as out gradually is from things

but Cardioband become important same So time. more important will PASCAL will at more become yes, the

Operator

Thank you.

BMO from comes question of Wuensch next with Capital Markets. Our the line Please proceed. Joanne

Joanne Wuensch

for similar CENTERA? an and of marketing in taking outlined thank sort to little the us you better please afternoon a give efforts. you Ultra bit questions. want Europe, to how update Good selling to understand on I Could on the CENTERA the approach you

Mike Mussallem

we proctoring the the have the I that original for on called training say launch Yes, based that's and site we're and going the think requirements probably of Joanne. The down plan. Sure, affect proctoring CENTERA versus ramp. feedback slowed our we plan to would original rollout minimal increasing but

from some the that a So that to even only the is gone very, we very and the course so during that and feature number year. and valuable we positive forward we centers limited of to so get it through training gone feedback have though folks of far up we've find those a ramping proctoring, look the

Joanne Wuensch

there there tier is more bit. sort about second competitively average question, create which to What little to stage seeing compete at competitive terms talk a are a in of you. as want And price? on pricing I a Thank a you of prices? you selling internally two system And out Okay. landscape the on

Mike Mussallem

thanks, Yes, Joanne.

in continue trends see talked the we we've that of in about no, to So, same much pricing. the past

is big in here the we implement Europe a introduce be ultimately let's workhorse thought rest that the In our the not plan Europe, all strategy. tiered our We pretty of a best we will the and our product for very technology Ultra Valve think and -- have to comparable available between globe. of So the today. delta say We us pricing to is competitors. and U.S. pricing do there's

Operator

you. Thank

Please the of with comes Mills Genuity. Jason next question from Canaccord proceed. Our line

Jason Mills

question. Hi, for the Mike. taking Thanks

in, center as centers patient's Could level, centers some the mentioned the newer the -- into will by relates that be case Will that at when altogether? will though or do all it think will older FDA want larger grew you a the fundamentally would level? bottleneck talk to TAVR, to different several or quarters. be sort of advantage that in more perhaps whether extent It about the also liberalized screening of the it to didn't seems low or the center is approved bottleneck vis-à-vis used you ameliorated patients they trend a mind been take at the can the that bottleneck How not fit criteria approval it the get to about change faster. and will some to process and risk for point with extent. you've your you screening risk comes. it You that if profile change smaller talked better at the most will That's if to come prepared

Mike Mussallem

Thanks, Jason.

question, Let tell you I me answering me there take not. a at shot your if can or get

that's it not improve a the best can in as painful. yes, we The right. process the patient will clearly are process even best in best and should have prepared, streamlining lead And, be the they most some visits You're is and that centers, less they're prolonged NCD, the to it because and get the centers business. big as the today if it modernizing experience and staffed

also that it's So like to that, are same having said it's and taking the also that ramp centers so up. that competing going tricuspid. like mitral mention therapies on sounds large I'll

So have also little a they of split bit attention.

of So mixed it's bit a bag. -- it's a little

very have that a being this with difficult We at time accurate point.

Jason Mills

acceleration enough these bring think discussion, I'm will only in this States the you centers procedure into to Do the at they guess an you to the data data. the risk do think back TAVR but to government with Japan That's about have question they to I this not And not United impact how low but the impact States are next that. how general going my data the really quarters to question or also in then the going the fair. expect move say and is the many look low risk comments needle just an there? fit only and market to you over impact broad outside respect in United to how United do those into to it compelling is on Do on sure have States four globally your share allow eight

Mike Mussallem

right, a take I'm Jason. answering there questions at to there, going several are All shot

positive First some profound have and going of to in long-term. all we the really think impact the data was it's

a slow reasons. medicine changes to to mentioned going of As it's we've some number for take time practice

probably likely and to international, of little Speaking be believe in because not we impact the reimbursement till come change the XXXX. expect the enough lot be some near-term going take the the more there risk And countries be important to one guidelines of and slowly. we've there doesn't the population able are also is to excitement actual referral modest this clinicians is but to approval although the country. to bit that's to is change, a very low heard patterns of a handle time simply to in centers powerful, from we of in these is many constraints In Japan, data going that

be there don't lot So may constraints a data. with have do to the PARTNER that excellent X

Operator

you. Thank

proceed. comes the line Taylor of question Please next from Our with Matt UBS.

Matt Taylor

question. the taking for thanks Hi

same comparing no from the Do the Do have for was once opinion; could once it quicker be simply very question at you do slower. ramp qualitatively, approval versus intermediate. think you So expect was wanted you good to first time? I data you the the risk ask just reimbursement low what in the get

Mike Mussallem

again long-term we impact. That's thanks. but one expect be call. do ramp it's think We tailwind a going a favorable and more more of to Yes, tough a to with be of a it'll

Matt Taylor

ask Okay. the because NCD it'll how for the with one I just see some change it smaller final, out follow-up we'll centers, wanted of shakes on to things. ultimately the

over And was that? their for preparing them help to help to for to get do What as prepare Are do doing perspective are for help hump. your you so have I streamline that screening? do from or help some training things differently them organization them to you you wondering an the

Mike Mussallem

Yes.

going same. I'm be it's sure So is probably to to that the change, not training going the

is to going accessible XXX based there new they be it surgical obviously hospitals the if in So many and potential It’s have forth. draft established the to capabilities, need centers need to requirements the it of They so but have to PCI's capability group make accessible, there's just to larger of the still think have make to the catheter procedures. need adopted handle to that a to I need capability. and need

the limitation. a able is to we'll don't example We and than to for that do today there come be valve the up to number centers the it X,XXX centers there's that potential more approach of But So we provide for replacements. think to necessary. expect surgical support

Operator

you. Thank

of Josh question proceed. the Jennings Company. Please with Cowen Our line from next & comes

Josh Jennings

root SAPIEN FDA could CE is as Hi questions. rate potentially hoping to SAPIEN on good evening, of we to thanks you get on X for approval Ultra start taking remind patients the was Ultra and I really you expecting hoping be just how the us X many pacemaker an but my not Mark and a just question have should whether SAPIEN X. similar or needed

you portfolio? the that check ultimately so the Ultra the pacemaker X the with in low the X SAPIEN was is only because just sanity wanted is could which in I us difference But added going feature. I pacemaker to workhorse that that help expectations rate the PARTNER for to rate if design spurt become just trial. think

Mike Mussallem

the going because data that that are that don't be See, see designs. know out pacemaker I in don't we we're to from going know be to expanding balloon in I very patient's different. comment Josh. not it necessary different and we say our rate, the Yes, terms think we're just myself expecting to not expandable I'd don't share a to substantially thanks, but you'll that I'm and for self designs on number would relatively We the there is have it compact competitors play similar of think is But CE permanent the really our but difference the from and the see designs going very to be different it Mark, to of anyway. I expect frame

Josh Jennings

that just think and patients. about sanity share to then Can potentially help valves losing just generated positioning in better at has X annulus questions. that for taking was think been Thanks And ACC smaller cases small again don't lot that small patient just you the wanted SAPIEN Thanks. those valve you and us around check a in serving those my some patients annulus. had prosthesis mismatch self-expanding buzz Edwards follow-up there

Mike Mussallem

Well was that think presented without of a valve valve of sizes X this the PARTNER in speak had results that that you stroke our at distribution really for I dataset. themselves. of important Sure. and data saw the were sizes had of kind a of patients the in and representation year and the significant We XX% all full alive

about answers of ultimate So think the The arbitrator question data that. of I is prostheses it mismatch. sort the patient of kind

Operator

Thank you.

line comes Credit Miksic Matt next with of Our Suisse. Please proceed. the from question

Matt Miksic

questions. our taking for thanks Hi,

two play And follow-ups X either of you've year, in quarter, about patient contributing you small you PARTNER that on the pace centers been the that in us do one this seen -- how me. these and where growth remind bit to over Mike, of if of anticipation a of follow-up could you the that might centers, of terms NCD out new the Just in the for you mentioned growth I any how effect centers talk anticipation there's for Scott? whether this or needed it go little time.

Mike Mussallem

Yes.

their that they have attributed really X, their affected was for now around we're than patients this So driver they're higher new a fact take and more what PARTNER I growth. at centers, before by a the local that just that's group that been I of new you the don't some available much it's growth think saying look and I the of that's think key to larger the referral pathway rate if or those wasn't and know a really much while. centers, NCD is is

Matt Miksic

the I a Like number pause centers. mentioned? of I or things seen a centers actually new up and of the or growth or see the a was of opening have words, the just you speaking of I because slowdown more pickup other number around of anything in

Mike Mussallem

Yes.

plus relatively number to think draft would it's surgical be of been AVR. NCD the if recent here basis centers more of through likely be And approaching added don't a But we So think to X,XXX centers new do at it over the we added, number the gradually. has that the comes the anywhere centers they close would again centers goes consistent far of since pretty past. consistent stay there

Matt Miksic

in surprise Can Got offsetting a you it. efficiencies, pleasant you as Thanks. of of or of And sounded to mentioned were bit then, could, investments the any a little about worked? the you color that that making and if can that it sort quantify been the sustainability some talk you Scott, that how capacity. manufacturing provide it they in you've like and

Scott Ullem

Sure.

on trying the around components of to we including the bit a can leaning being I'm that preview So products. our gave harmonized and spend different as And efficient improving making as time a logistics make our efficient be. focused possible we're and of we they facilities lot on and the then base as supplier sure are that world outlined to actually as sure this for supplying also at out we're of focused Conference Investor getting really our really a December operations little different the and yields. slide a across in had we initiatives that our some

making the has in position together facilities a that the the in our incremental quarter, the first continued us offset pretty able expense the of for got all sure may capacity well with So efficiencies as left associated favorable and we redundant think rest to the just year in production that we've world. around investment not be

Operator

you. Thank

Our next line Nudell the Please of proceed. SunTrust. comes Bruce from question with

Bruce Nudell

especially been have Jagger and benefit what effect, popping Mick what's asked, this a X Hi just questions course looks X outcomes. is clinician guys. patients Good discernible been to patients I should the and reaction like in afternoon. given I eye PARTNER had? just of but, on and your Mike, Most qualitative of to add what physicians level, responses in hard PARTNER of a very mean how base the

Mike Mussallem

Bruce. around history amount long excitement very of popping valves results. thrilled it eye a were it as better close right. moments treatment that like I years felt and was have for it And said better. that we and those and truly seen especially of these been heart really this, like XX with big been an this the thanks, data therapy over think held well Yes, one clinicians moment, clinicians just the see was have you the of the get and this incredible many those of for that are to those good top There's this Yes, of history feel kind in us to really of this the

it Ultra I'd said and amazing. was the relatively rest But really were our having on approval beyond to long-term slowly encouraged we a of and basis. that happen. own changes coverage to So even it's know the it valve going we're practice But that, the in of results say expectations. medicine take

Bruce Nudell

plus of much you how about about institution sites or the did proposed rather that gone the right the might one And do was feel volume or starting that's an have did notice area year you impact optimization that up the of thing per TAVR NCD cases it an one. requirements the is level? look not for program the like XX for can I Do but And for a have maintaining participate? on SAVR an -- think

Mike Mussallem

to measuring we big well like picture surrogate day. the Yes, volume. forward We're a perspective, with look you not from know quality a

moderate the think having becoming the So not alarmed I of volume that, maintain I to program. that in said But requirements and look forward requirements the do to was particularly terms CMS we're reality. the more by

Operator

you. Thank

come Please will from question with SVB line last of Danielle Leerink. proceed. Our the Antalffy

Danielle Antalffy

you increases taking what question like the bit because maybe the gives it I little indication you curious conversations you And the more feel off the weeks opening are much sorry I talked it we're but of volume that the meeting year. as risk centers start penetration it, you for confidence having this follow-up growth the low afternoon. a Hey meaningful to guys. gives a expected it but up at acceleration I then their doors is about at in again. quarter sorry but you question. addressed did the two and acceleration? just impact Mike, risk we you that are the on it's have Thank but we I you about appreciate Good that potential that, Analyst accelerating know pretty Thank in growth to blowing so low at now end color to see after I confidence question and words And patients with risk the saw about ACC opportunity that the guess you data? my through really was about ask but I move so I'll much. the ask really intermediate the know guys call, those there. only the mean just

Mike Mussallem

Sure.

do the is England compelling things, ACC Journal why and up. So one think stimulate data that was We the was just going volume that the two go at growth really we market. think data the is will to it and New that that the presented of that

products very we Secondly, new the think much well. difference as a are making

have to those be to And to -- that's going And And even that. beyond going be forward that some important. impact so so we could are that's the look NCD all favorable.

would seen it's as of going say I terms before much In seen what we've or planned. far. very what we've so

things the way point early it's but very do to be positive anticipated. it this are expected much predicting we at proceeding to We any and that

Mike Mussallem

on in question. by is questions the and continued And want for for call. clock out Well telephone. thanks their Edwards. Yes, additional the And everybody Scott welcome interest any I shot I running to this thank

Operator

can Thank sales joining us included at growth are this in announced in also rates the mentioned of found website for special GAAP and numbers Reconciliations you call. for release during Investor section and the underlying on today's today's which Relations press items between non-GAAP and include Edwards.com. and call be adjusted

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Edwards Lifesciences (EW) 23 Apr 192019 Q1 Earnings call transcript