EW - Earnings call transcript Q1 2021 | Edwards Lifesciences Corporation

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Operator

Greetings, and welcome to the Edwards Lifesciences First Quarter 2021 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. Please note that this conference is being recorded. the of to Investor turn Wilterding, host, now President Vice Relations. will conference our over Mark I Thank you.

You may begin.

Mark Wilterding

Chairman call Thank you, us. Mike and today's joining Chief Financial you thank Executive Officer. Mussallem, Scott are Ullem, Diego. Good With afternoon, me and and Officer; Chief for on

first Just close released trading, results. financial Edwards regular the XXXX after Lifesciences of quarter

for speak for trials, that and on During date as they to: release today. and press will guidance today's in matters to then of were currency the forward-looking are included use the competitive statements call, note which limited does Edwards after These management made, them assumptions based obligation opportunities, statements regulatory results will foreign include, Q&A. remaining making be any longer-term litigation, on and time financial but not aren't management only and reimbursement, discuss statements update Please statements approvals, those undertake clinical that expectations accompanying the and projections. financial and These growth fluctuations. estimates,

in found these edwards.com. all annual statements Edwards' press the other the Additionally, website with not and to, factors but at limited important of and Information results could on including, company's differ uncertainties, information may associated SEC which Form XX-K product safety be concerning that release, XXXX filings, on cause our the report and risks cause materially. that are those available to could pandemic involve actual differences the

and over mentioned With like adjusted, this is measures. they for GAAP in turn Otherwise, that, Finally, included between comments. results. to Mike? Mike a when financial his release. non-GAAP the non-GAAP to press during quick referring are to underlying numbers reminder call I'd are terms GAAP management to that call today's using referring and Reconciliations

Mike Mussallem

Thank you, Mark.

dramatically of I'd like better priorities the in XXXX on impact a support our after the few to on the to due people Edwards' company. response like of by employees I'm difficult briefly I'd to environment later and pandemic our financial many were pandemic XXXX also sales community. Recall an QX and recovery current as our patients, and around to reflect that the struggling world. in we procedures signs our anniversary crisis, disruptions. extraordinarily as longer-term we efforts weeks year fell on global to our encouraged although the recognize the results, are of to One X-year impacted and the still As discuss COVID touch last that our

all this product growth sales Our quarter lines. better expected across than was

impact outlook. as continued the Although our global system, the healthcare in positive quarter, the based the we pandemic will environment have on expect we XXXX exited confidence we

during to We an sales important mid-teen pandemic. even that treating believe continue structural highlighting of this will heart with year patients, importance for the growth, be growth XXXX Edwards

and large We milestones. in meaningful also underappreciated opportunities progress anticipate Recently, several important expanding XXXX. underserved transcatheter on we achieved

Let X. me mention

Also replacement. mitral transcatheter pivotal transcatheter I'm U.S. trial that at low TMTT, II week, recently the EVOQUE Eos, this in transcatheter stenosis. with were in approval begin TRISCEND tricuspid received X. treating and transcatheter in And replacement or first to SAPIEN surgical month, our a TAVR, last with the therapies aortic pleased risk trial we patients to approval mitral we patients announce Just pivotal patients Also, moderate replacement treated for system. initiate suffering for from earlier aortic initiated TMTT, tricuspid to or valve next-generation Japan we in received

of we innovative beyond and strategy therapies. our in Looking pipeline remain long-term XXXX, confident our

and us employees drives around culture day. every the patient-focused motivates our world Our

enabling Despite R&D future and aggressively organic we've strong and exceptional for value breakthrough that growth. patients Our returns. growth significant shareholder invest continued targets therapies for can disruptions, systems, COVID create to sales health

body the robust investments clinical addressing impact to accelerate about today and impact our clinical eager dedicated generating of of of guideline are And studies partners its important also X/X slowed enrollment evidence. reminder, development this supported our the and research during clinician the focused clinical studies. pandemic, in on a pandemic changing in As a research. are been although have on Regulators

on Finally, over maintained I want last our navigated to we value year. creating provide long-term some on the how perspective we've as pandemic focus the

continue invest our in We our infrastructure. to people and

across protected team. During have grown a protecting We uncertainty rewarded many employees the enhanced our and widespread impacted when employee and our incentives. time we prioritized have families benefits, globe, performance

extra on communities work. We provided We our facilities research and around employees And the to navigated additionally, Edwards' agreements adjusted COVID. expanding ahead our support the as where production they also world. to and support we moved hospitals live

we fact, of community vaccination facilities headquartered. of our where the site to recently a converted our X support COVID into is one In people company million mass

a world Edwards the as As able will be even be pandemic. and patients from that positioned emerges than expect stronger company, more help to ever before we the

basis. quarter, with sales this quarter for ease-of-use constant differentiated by $XXX of the Now on In The QX sales with quarter Recall quarter year billion how our a global year, last our We line a pleased first rates, TAVR, turning of efficiency. were potential basis improved from up would SAPIEN to length that was guidance platform $X.X up reported assumed on and first low sales X COVID. were X% progressed. currency unaffected complication remains as the sales stay first an million, which quarter ago. Ultra We in X% in with significant underlying be results. largely

fourth were global on procedure system results, were year selling that our flat our January, our the stressed and prices with QX COVID comparable TAVR was comparable. quarter ago average Consistent estimated was with Our the during earnings global call growth. U.S. that procedure guidance months. and TAVR winter U.S., we healthcare overall growth In the with late in and growth estimate the we stable QX sales

role We in during hospitalizations valuable decreased TAVR a serving quarter. COVID the grew medium-sized and are encouraged, centers during procedures vaccinations the that patients quarter. U.S. played however, as and Small increased

have to estimated the many been on the in heart comparable. was quarter, and continued year-over-year as of demonstrates the Edwards' first We procedures centers the a double-digits the basis This grew pandemic. TAVR structural interest growth in quarter care state-of-the-art provide centers clear we U.S., to activate throughout new low smaller patients. we this for Outside

Although outside vaccination growth uncertainty versus the Europe we range. growth in the U.S. the countries are more slow of therapy start, in TAVR to adoption outpace in progress rates prior is the provides was year. year off lower Edwards' underlying where countries a established. remainder TAVR for the mid-single-digit strong the Edwards' with the

disease. the Japan and was regional disrupted among of focused immensely disease, strong undertreated aortic were therapy. centers stenosis TAVR other growth more to Although remains TAVR due lockdowns and treat patients Sales uncertainty as of in prepared countries on patients, patient availability the urgency flow their and remain increasing was to an we about

As earlier approval is treatment this when we in anticipate risk. low previously increased year. We this surgical month at Japan reimbursement approved noted, X patients for rates received SAPIEN in later

indication to addition geographic In our TAVR to of expansions. expansion dedicated therapies, remain pursuing we

who Our meet trial severe who focused symptoms without on recognized but valve stenosis, guidelines patients groundbreaking TAVR aortic have early replacement. for not the is and current do

to these stenosis future trials, we of precursor Separately, once a with later be begin patients X this was as year. approval last of TAVR I'm motivated patients. treatment treating pulmonic and be benign also as morbidity participating believe previously recognized. pleased for Mark we're to report received mortality may rates for we with enrollment recent AS we for learning and actually option severe Thus, that or what a Based to higher thought aortic previously expect FDA patients enrollment in on we trial complete replaced to are increase pivotal associated on the trial SAPIEN year. approval a a the to moderate valve may position. We begin as we in repaired week, received this of sites to expect than TAVR CE enrollment

we next from European patients. month, ahead the as registry expect X in on to sales in the a bicuspid on first at confidence trial In upcoming low-risk clinical we EuroPCR saw virtual range that results XX% follow-up strength long-term of the Looking XX% the we on summary, the end well data TAVR our the to grow will based as SAPIEN underlying late-breaking quarter, XXXX. meeting have

near-term disruptions will which digits. confident implies $X the that more low opportunity a large exceed XXXX, of continued rate compounded annual year. double half COVID-related global and We a this regional by remain expect billion the in second normalized We growth

Turning we're from portfolio suffering pivotal our TMTT, differentiated tricuspid and across to X disorders. support enrolling to trials of patients valve mitral technologies

with of quarter, X the trials This we PASCAL. for progressed CLASP pivotal our enrollment

year. severe and patients safety PASCAL patients begun the with designation. the replacement of U.S. for the approval II with late to expect patients in commercial tricuspid evaluate system trial regurgitation. first to pathway randomized the EVOQUE with effectiveness will pivotal DMR accordance This treating is also in We've This the tricuspid be the next of continue expected TR system TRISCEND for EVOQUE approval with FDA's valve trial breakthrough the We in

replacement the treated through treatment addition, performance Eos and advance be were replacement EVOQUE first This which EVOQUE strongly next-generation with of MISCEND In transcatheter is designed patients Eos mitral We transfemoral X in patients and delivery underserved to with our SAPIEN French EVOQUE platform believe mitral these regurgitation patients. system. positions through strategy the the safety our called will with leader to delivered study a of system evaluate valve a low-profile treating with the recently study. Eos, the sub-XX MX us

to forward upcoming meaningful our include including XX-day As across late-breaking of mitral tricuspid the outcomes presenting These at presentations. TRISCEND ACC our from evidence, and outcomes trial CLASP report look multiple data EuroPCR from for we transcatheter study. virtual repair of with we body replacement EVOQUE our our and first the portfolio medical meetings, expand clinical longer-term

results. of of were first our adoption sales system million, $XX PASCAL continued and across centers driven our to activation Turning global by more Europe. quarter

Assuming the COVID, ramp Surgical to tissue of across by XXXX the as first favorable global which as treatment. year. to preassembled sales advance in root of Surgeons, U.S. million we treating outcomes. start We adoption of lifted the this training, the hospitals heart meeting RESILIA course the a commercialization, need. more billion at was valve in aortic including demonstrates of with Edwards' physician key in $XX throughout the we And we with aorta, enabled patient we're of opportunity by surgical meaningful Sales world. outcomes quarter remain with that procedural progress premium an remain growth quarter in focused require a X% adoption we sales expect conduit data of and patients approximately tissue success valve, We tissue first durability our technology. tricuspid cases from valve unmet and critical transforming underlying to valve. RESILIA a basis the regions In INSPIRIS In Despite We XXXX. COVID impact, are prior the resume the the remain adoption of that China. by was $X the steady quarter. guidance increased year. replacement patients. soft recent first RESILIA, milestone be continue patient of XXXX real-world also gain to TMTT sales our Society sales global our associated who remain of around clinical the aortic committed by the pleased we confident Heart, trial anticipate Notably, Thoracic and summary, encouraged making all Structural X-year very toward excellent diminishing traction mitral over valves, million, on initiated KONECT and ascending continue patients over disease we of of will to staying improvement global COMMENCE for estimate are encouraged by continued treatment transforming bolstered $XXX structural declining the We COVID-related drivers INSPIRIS presented and reach products Adoption the improved the on the to surgical and XXXX clinical

in cases Structural single-digit received Finally, in of reimbursement regulatory premium new for valve, high with RESILIA MITRIS Japan, a confidence in sales our adoption technologies. Japan we our -- to newest our technology. full mitral our we this for valve, that underlying tissue first we're pleased have announce our with commercial Yesterday incorporating performed year driven Surgical our differentiated XXXX market by Heart, growth summary, in In in range we the first approval innovation.

levels. hospital remains $X.X $XXX also as sales elective first billion underlying Demand increased market driven current basis, to in sales to increased grow orders continue HemoSphere operating of pre-COVID of by an used procedures near Care, units. for recovery. mid-single-digits the believe increased for care through both intensive and products XXXX. Critical technologies heart in will began room the show of recovered to structural million ClearSight spending strong, X% in our quarter non-invasive In our surgical used high-risk capital on We and cuff finger signs surgeries the

hospitalizations used due devices the monitoring to QX. pressure ICU Europe demand U.S. beginning remained at in both disposable elevated and of in the the TruWave Our in

the we decisions continue to focus to the continue for to We excited year for expect range sales about turn underlying technologies critical care XXXX remain full of Care. clinicians and as pipeline their Critical high now to our We I'll to better growth recovery designed call in And smart over make shift our patients. innovations help Scott. single-digit

Scott Ullem

Thanks, sales Mike. health gave all first the the first than sales sales back Well, to care we of which per us growth and X% regions to are the advanced in January. share The able for year-over-year positive our quarter This of our start confidence XXXX. grew underlying that X% impacting of stronger the to on expected first still the outlook lines line, stronger-than-expected in Despite a encouraged of was product $X.XX, we than quarter the adjusted quarter, growth were and improvement through the across our which globally. performance continued year. the year. we quarter patients we when guidance fell gives but helped in resulting year-over-year our balance during in performance better Total for quarter earnings global an basis, our as the was the in flat bottom we was post exited choppy, the position, system sales higher by in COVID therapies

$X.XX projecting across key variable between sequentially total per geographies, earnings and resulting quarter to remain share to in sales second $X.XX. the we're our billion grow conditions in to $X.XX billion, macro of adjusted $X.XX While

expect COVID, strengthen to business and As to our as travel up. and of we impact trials expenses from continues to ramp rebound the clinical sales grow

XXXX. are our guidance for ranges all previous maintaining of sales We

year to for $X.X for million. earnings, $X.X to Structural $XXX Critical to $XXX $X.XX For total full $X.XX, and And $X.X quarter Heart, $X.X earnings share to up we Edwards, $XX based of $X to per billion TAVR, we adjusted $XXX from sales our $X.XX. Care, million first billion raising to approximately million for expect on Surgical guidance million; billion; for TMTT, billion; million; to are $XXX

additional cover details results. our So now I'll of

For reduction in COVID, incremental costs negative improved first adjusted year. responding exchange the was driven our XX.X% margin manufacturing by efficiencies. a same profit was XX% to from compared by partially last impact quarter, with This the gross and foreign to offset period associated

first Selling, We million expect adjusted $XXX of costs, currencies, million continue sales our driven and margin be primarily by administrative the to This increase resulting euro, personnel-related XXXX of gross offset in or profit to between COVID. spending XX% reduced the were $XXX general the and and XX.X% the expenses quarter compared travel prior by was OUS in from to primarily strengthening year. partially XX%.

as operating travel we earlier, more will the As and a year resume we I normalized mentioned anticipate our restrictions during environment. increase spending subside

as Research SG&A special development increase to XX% million transcatheter to XX%, continued items, was XX% and percentage similar in the levels. be quarter XX% result of in year to investments expect of full grew to $XXX the or sales. to XXXX of pre-COVID This continue a primarily excluding our innovations. expenses We sales,

developing XX% the year percentage the full as sales we TAVR new R&D as to for generating invest evidence we For to indications in TMTT. pre-COVID and XXXX, continue in to of similar expand levels, to expect to be range, XX% and a technologies

for This XXX tax included accounting taxes, point stock-based to from basis reported this a Turning was quarter our rate benefit XX.X%. compensation. the rate

accounting. estimated between full our be stock-based expect and benefit items, rate special points excluding including X from to of XXXX, in continue compensation percentage an year XX% We XX%, to

gross quarter prior reported million increased quarter XXXX. to negatively first or X% XXX $XXX defined Relative about January flow profit the $XX year points compared rates less FX quarter impacted basis we million, by growth At sales rates positively our impact points basis of impacted the million current margin rates, million. exchange to about spending positive year. Free compared cash by the sales first capital quarter to of $X.XX. $XXX $XX XXXX as year. for to EPS approximate by FX now full cash was operating compared an $XXX first activities XXX or Foreign expect million, from prior first our to flow guidance, our rates

the an to turning I'll Before with finish update over Mike, and call back our balance sheet on repurchase activities. share

maintain offsetting shares repurchased remaining billion We We March during in continue X.X $XXX flexible and a cash first with to have prior shares dilution our $XXX outstanding XXX the to the XX, opportunistically share strong of were sheet execute approximately balance and compensation continue strategy incentive over X well our and quarter investments million million $X.X as million to shares first plan from outstanding as for repurchase our Average as million XXXX. of the reducing approximately We quarter quarter. in time. from million, approximately authorization. stock down during

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

pass Mike. that, I'll with it to back So

Mike Mussallem

our To Thanks, disease, remain serve and people, new growth never Scott. from strategy the our investing patient-focused have our in long-term confident capacity. we separate stopped innovation in heart our structural technologies and innovative patients We many our pipeline.

stronger emerges Edwards company, as in world to and help the than a ever expect positioned will from a more fully pandemic. As this be patients that position we even

over to So with Mark. that, I'll turn the call back

Mark Wilterding

Thanks, Mike.

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

queue questions, possible during have of Diego? many remainder the and as additional as the the participants call. you please re-enter answer If management will

Operator

first Our of from comes Bank Bob Hopkins question with Instructions] [Operator America.

Bob Hopkins

that is United the States the guys the put and the of numbers it get I'd TAVR gave growth is One in out your the quarter outside especially us. excluding of up in some love States kind United and you first quarter Europe, given outside on you the thing stood rate view that to

about a with specifically, So wondering TAVR. was take if strong U.S. Japan the and outside quarter just what the happened maybe Mike? Just quarter, really little more talk in And your this I was love on bit that. you could China

Mike Mussallem

came Bob, the of that's yes, in Europe nicely, and Clearly, Yes. other a though did performance observation. grew Japan OUS even up this quarter. most And correct our countries. pull from

Japan significant in And size. is so pretty

it so But certainly it was meaningful contributor to And growth. really wasn't alone. a

were bit could just go numbers You are the frankly, stronger. up. a comparisons But

therapy grow very see continue to factor. China, meaningful results, It not that We those game. a not it's a contributor was those in to that in early we're areas. so really

Bob Hopkins

curious, one Okay. there quick in then course that like And you in over Europe on with U.S.? think And Or did Japan get pretty this just better then the happened you that follow-up just anything just, was quarter? the what on quarter, it did on I'm worse was Europe, is the stable? Or following results that improve particular gave Just it of that. COVID? curious

Mike Mussallem

Yes.

So drove many higher. in thing adoption Japan, that rates haven't been disappointed this. actually, specific been focused there We've that years, in was no for and Japan somewhat

long-term consistent really so to see just the adoption. continue nice this effort, a And been it's to and has and

the in exited looked you rate countries pretty it the probably quarter, of been say, those solid, growth are for in We quarter. the course in the meaning kind think, later the Europe, it countries. it interesting. were And glad growth countries all less a to In strong. traditionally to some It more I see across will was this consistent the bit of on similar have choppy, We that I overall approval at have was still that if little saw would having not Japan of penetrated, that low-risk through year. start

there, don't notable I Bob. anything So there think was

Operator

question next Robbie comes with Marcus from Our JPMorgan.

Robert Marcus

you heard good XX sense with trends the a older it'd many the starting the quarter. population the Maybe question to to then that time that trends to is with to you're so, in a And upfront. I've quarter of the lot be particularly so level, I'll of COVID there? U.S., see a durable treatment Great. improve from second diagnosis especially Bob's screening a Congrats the starting went to how trend? maybe you're want the throughout seeing, to fully doctors compress. now from a see that ask of get sort opposite the on seeing of question company of vaccinated. great I is TAVR just a on time Are and adults, and and if if

Mike Mussallem

Okay.

course talk the U.S. the would U.S. let's during choppy. the about wasn't no but quarter, about it, The call we It up. straight improve did doubt So it of

and March. January So for got clearly example, things better were February, tough in and in

we XX% you put on, But pretty still got they remember the the end in Although spring And our that well, probably as felt December about recovered upward we're effect you first to January the coaster When Robbie, in the we trend. we good of investor reported end in conference, I going. just of little the just of that then saying, clearly, of and we're an break, here, range we QX, growth TAVR but were we went that feeling we're it. when March and back you and when a based well. nicely. toward had got went were sort on things lower estimates XX% roller that out to range,

we confident So going XX% forward. to about XX% range feel the

for U.S. you So get the helps a hopefully, that sense

it All in easier? way the that of identical terms is about, the are not hospitals screen question patients. In they

more some you you challenging. you run are are before happens hospital. although come to through, that to And one things all efficient, also tests do and others addition when COVID, the COVID more so into the have tests efficient more of the that have And you getting in would so

So fear it addition patients just to a becomes in factor. for these the just hassle

trend The good seems maybe are some So Hospitals I a is be stay wouldn't Overall, that a it that down. but it's is is hospitals a get of driven, news better, And coming improving clearly say little of uniform. in it's COVID length battle. well. still to will but as regard.

Operator

Our next question ISI. comes Evercore with from Kumar Vijay

Vijay Kumar

in your end more to the perhaps XX%, low with appropriate. on comments you start guidance here. on first I'll January, Maybe Mike, seems two. on had one felt I XX% the

at the have QX it procedures beat high back. end, looks just come like You

last -- XX% are versus like revenue is a XX%, of growth TAVR thinking, numbers? that more I this XX% you I'm at So off of think right? just I actual guide, put we numbers, point And actual be a guide? that, the high looking 'XX we look at should finer the to the year's end that's XX% If TAVR mean, to fiscal to

Mike Mussallem

No. Vijay, the would good we're fact Yes. middle guidance guide of putting we about feel specific not pretty and the about to out the place in pretty not guidance the place that better guidance there that Vijay. first that and toward probably more tend it. range, people We

Of it and higher course, is COVID. it's your is what dependent somewhat going lower. to possible be for about to perspective And this on be

or there's Europe, the really, If balance us certainly like So even vaccinations more it challenging, But battle, -- U.S. we on winning start trend it the advance. things will to in numbers. feel higher nicely that the guidance go the pretty go our in is put toward if I end. COVID pressure we and COVID tried across helps

Vijay Kumar

trying I then look than ends how did I Is valves one, question, mitral? take Edwards I'm to if two-valve had replacement Are when have guess a perhaps a trials I we a guess to different Are mitral make that trying question guess of mitral? gotten big is, TAVR? time we was, I is and a select the Then patient we And that TAVR. to strategy? Mike. know the you trials, selection really being to [SAVR] [CLASP] matters. what and a larger Is X a SAPIEN side, TAM, versus much ask question the than be just these MITRA-FR on Understood. in at look, I portfolio Or is at thesis, your MX where picture have different? derisked much for Because is question bigger you've how need point going to a bigger mitral derisked patients before had this is EVOQUE. the exactly I we've approach? up perhaps more

Mike Mussallem

a sense energy. go think We of it and is transcatheter to probably us after reach, is in it think can terms the it's time after pursue that, for you within We in think a lot how going tricuspid. Thanks Vijay. with opportunity. Edwards our we a it's Well, dedicated for get of mitral really we're and right to big

toolbox. not I is You with there To fair it's it, know at this but there situation has not still in we're a now pursuing overstating around a out therapy amount certainly that replacement, the And more on and derisked. and of trials, results appropriate you that's I clarity right think would it There's point. use, each in would say see patients on tricuspid. time more limited clarity which limited for data derisked, and this data be frankly, therapies. to from you are these actually see is and It more leaflet them human start derisking you more known say and fully which more at And see point. data

some we there's most because have many more We maybe so know advancing in this more technologies we And still to learn. but ideas. pretty good have than space,

reporting these getting And a the for mostly big meetings and opportunity. understanding attention be the from so to a us mitral of tricuspid trials clinical your to turn I'll where sense there'll better get results

Operator

Biegelsen Fargo. Our from question Wells Larry next with comes

Larry Biegelsen

Mike, one on early on TAVR, TMTT. one

in earlier just Mike, endpoint reached clarification, just on the Just that's a you expect in updated XXXX. I TAVR, in I April, thought was be XXXX. just the that complete the enrollment, will says early but heard Maybe it say December clinicaltrials.gov to trial you primary

expect we see a on data I status So and is, you kind when follow-up. have of readout my us is one tell could the what just can And enrollment to there? question

Mike Mussallem

Yes.

striving Sorry, enrollment completion if there end was to is a by the lack of clarity infer on meant it. achieve What to of XXXX. we're I

that comments also year that as we a than control. QX, and COVID my we're to enrollment gets bit going on from more the under and have like gotten lighter have a actually in may increased enrollment You was that anticipates goes little little

we're hard on Remember get So there's this working that a well. there. as to X-year endpoint trial

Larry Biegelsen

you're On seeing mitral helpful, nice traction getting if be and willing to there. there, You more? I be a of willing bit versus would is little to any traction talk helpful. kind you in about But split tricuspid to tricuspid. provide Mike. That's out a can what you're -- you're bit little don't know color TMTT seem mitral business the more and

Mike Mussallem

we're what Yes, clearly, pretty I there Larry. Tricuspid in mitral. Yes, great in at a seeing. is We're this. still, pleased sales -- that is to to still it's is in opportunity We this majority There's centers think there's are tricuspid. least tricuspid. but ramp been mean, the now, new, the is a than sales point, doing nice related one, the a right still with at pretty opportunity mitral impressive more is more

for very activating actually are training, to important, success know if careful so But critical helps And trying we sites great your sure Those question. that that get I outcomes. answer is factors. make don't Edwards, all

Larry Biegelsen

It does.

Operator

Our with next Josh Cowen. from comes Jennings question

Joshua Jennings

congratulations have the strong I the questions TAVR. start And on two year. to on

a be TAVR can the and of and still the sits bicuspid what bring The bicuspid, and cycle XXXX. low-risk a it's is first needs opportunity, place from relaying is very do mind and data replacement been And Mike, where data go? into with it as the TAVR question on the sense But past just SAVR to know made in hand the public. get now? to has maybe team opportunity TAVR clinically today? framing SAVR X where maybe to you the low-risk And that done registry where out the if even about but for PARTNER just into registry patients TAVR thinking your with implanted one, sits penetration of TAVR just younger bicuspid And are I getting follow-up early, years, the TAVR, out -- wanted just on of you,

Mike Mussallem

Josh. Yes,

a at shot this. So let take me

So treat a with breakout data. what will have don't it's routinely share is believe upcoming we're And to of interesting our bicuspid with what patients. this meeting, you. anything I overall, pleased I EuroPCR. in We specific I lot mentioned bicuspid be we think

a have technology. bicuspid You're that of pretty a been going treated to significant report registry patients see patients transcatheter that are with of

interesting be of here you So That's the just that some couple insight. should give an help point within and months. good next data

what What and TAVR -- a the TAVR more plan clinicians journey terms be you therapy, given do where in we all a talking surgery, then SAVR, Should I might be surgery hear disease, versus first, TAVR right? second, very discussion. treatment? lifetime that's first, that. In second? the first the given given much their in a of And patient, about another their SAVR age, be What active and should for for how it should TAVR then be are TAVR

been there's really SAVR. as well strong good, says in think is TAVR some as TAVR TAVR and evidence that I

to So those be options. are realistic proven both

on the it's pretty And and curve the sort learning think on pretty any so given regularly, that podium And to for therapy. through I in a patient now it's we're trying what's best regard. steep

Operator

question next Cecilia from Our comes with Stanley. Morgan Furlong

Cecilia Furlong

really, you're factor with I and just really what's $XX versus in further expanding guess your about Europe penetration coming into to from again XXXX, in as million off the kind you I account guidance? wanted as you that TMTT account start and think expansion of

Mike Mussallem

also I were have within an sure. given probably Yes, to know But other, component thanks, to important I'm there's you is if the outcomes. of biggest expansion sites. the that The part Cecilia. sites is just increase pick short is, here. site more the one existing answer that, versus an Clearly, not the

Cecilia Furlong

Okay. just did TAVR seeing kind Japan of of that I terms has being in versus turn just interest driver And historically want that ahead low-risk of changed in Really reimbursement, of and to strength? to what guess seen of you've a recent what dynamics there. Great. kind and just you're if back I

Mike Mussallem

pretty general environment in we approved Yes, Japan the and do Cecilia. in Yes, treat to and clinicians believe clinicians disciplined guidelines. that that is

there's in the a we current that's that of And numbers. don't risk low lot so think

talked should expect that to in States a elderly boost. Japan dramatically be treatment where less are compared treated. low. almost it's as in There's before, we said be United about so we've as they to in just that, Japan rates positive are as still Having there the And but many

the We're to So penetration There's we do. pleased at yet. a of there. lot still to still but potentially rates, the have growth rates we're work pleased upside not see

Operator

next from comes Suisse. Matt question Our with Miksic Credit

Matt Miksic

dynamics and U.S. hoping, and they about couple affecting the the you business TAVR questions could growth that I'm of a we shed get maybe often globally in So on especially some Mike, of just how the light potentially

contemplated idea terms a to or how feed second of or the amount And towards maybe somewhat? of that the of much are of as largest TAVR what years is rolled potentially things, fair sort so. time -- that what over idea to this far two So TAVR having maybe assumed? that And you competitor X.X it one you -- keep preference I'll during SAVR by it seen stay and to that of your back contemplated and front back past first, in that somehow gained and share you've length question driven on an so lot then a you've COVID, awful from compares sort of benefited over for these SAVR, the of what you've share

Mike Mussallem

Matt. Well, Yes. thanks

So pretty to patients clearly, is say or the that's were It's length about advantage heard lot would helpful they focus vice about during hospital. that of clinicians There a on we been take versus the if stay their flat. stable. utilize or talk TAVR and things. to of SAVR Having mix, ICU pandemic. the I I that if SAVR don't how and haven't it we've U.S. have couple a versa in pandemic, relatively mean have hospitals versus of the for their said during remained much seen very TAVR you that, really example, stay

sign the COVID And but so observation. of that's it's the it's difficult just if to if times, related know or a that's

it's about SAPIEN -- only not competitive X asked share. Ultra, about the the second also our Yes, of position. really question pretty good We're demonstrated You performance was we you -- pleased part use, change able also the to and of its the feel rates to that. don't been been know really but going easy of that's have on remarkable, to with and complication length count low stay pandemic. anything be people it during to I has

we'll We the continue But a we've to of innovators state-of-the-art. positive clinicians. to gotten feedback continue advance be lot aggressive from and

Operator

Joanne next from with Wuensch question Citibank. Our comes

Joanne Wuensch

patients COVID-XX? have during a off procedure a quarter. cut of backlog to way And Is that nice there quantify

Mike Mussallem

Yes. that's Thanks, that Joanne, variable don't it's a some think of backlog tough Clearly, might centers one. centers. have a actually We across significant also More and we centers that tends what same time, their at significant. the the capacity a think do impacts screening. There think pandemic about when found be of that there's a patients. have but some, to it is we we lot. problem it's during that, it their that implants, impact In general, don't

backlog They So less in move necessarily parallel. up. you don't this tend built more or to get

tends So it's drive backlog. not one big a that to

Joanne Wuensch

It if of seeing terms of enrollment? question, of sort restarted clinical them, a what as as run I you've follow-up sort back terms of curious many in of trials. the of normalized sort in they you're what And call sounds to I'm are would rate

Mike Mussallem

any Yes, Joanne. clinical stopped quarter. slower clearly were we never the Yes, They officially first in trials.

that actually the was quarter. IID interestingly second nicely in a so enough, And pretty factor. the trial CLASP Actually, enrolled

to have and in done think as react But an what we been trials But I wasn't to impacted. I We're clinicians it So were this say we it. should thought be has I start we're uniform. -- most really pretty with, think mentioned, at regulators trials. I'd we say think we're they're to And overstatement. working back back that would try the at again. good that clinical we eager pre-COVID To get our of partners up the as COVID back think rates, building

Operator

question next Our Danielle comes Leerink. SVB with from Antalffy

Danielle Antalffy

and you. Mike, question question have PASCAL TAVR one I for one

Japan on talked right what's And what I internal about like way -- the expectations, then a follow-up way what to so think of in has Japan? And that. there? it. on change in don't But Japan, one on know, tide your sort is has again, a quick First, TAVR you've lot is to is in -- meaningful about the underperformed just going going how

Mike Mussallem

have to in other more patients within like needs of cases, many in going on. to amongst centers in stay in Danielle, it's what's Japan, because own multifaceted terms things Japan get region We for be their think there centers There in by external be Japan. treated, regions. begin have to high requirement some don't still to in pretty to TAVR They is panel. centers cleared an and all we TAVR actually

a help clinicians journey not to the it's of along so for simplify this that just low-risk, be And And maybe us it the clinicians. we're between the and able and way has patients. hoping catalyst and being to possibility

Danielle Antalffy

you the And might in new helpful. bit progress as -- has that, COVID I approach sort then you Europe as has late can big XXXX That's Okay. learnings Europe centers? but in progress has of blueprint -- launch, opening catalyst potentially you your what PASCAL, about talk U.S. the a little your Maybe appreciate mean given how what Europe you're next you on year here, had coming I a if an about in far impact might as talk you U.S.? could? for with

Mike Mussallem

Sure. is think a focused imagine. as we What Yes, a about in quite stay I been learning high-touch you're Europe, it, we've call right, Danielle. a to pretty Naturally, on, bit might model. we're maintain you really, trying this, and I'll vocal

that We're than Europe. easy. very to growth So more the that And to and though very really -- that close pandemic they drive we've doesn't been incredible make It's have about had can't the large. in therapy things sure basis. do outcomes, they we optimistic very Even The stay get adoption of long-term it clinicians, nice a U.S. the on well make have terrific help we trained important we anything results. and they're think try that

the imagine goes tough it and can is of Germany technology when this You biggest make Germany; times, doesn't it easy. user through so

on we're apply dependent the it apply Europe. we U.S. same bit going much to a in this. of the we're But in So strategy that

Operator

Anthony next Our question from comes with Jefferies. Petrone

Anthony Petrone

to Congratulations, the questions upfront. strong I'll on have year. -- two start I'll ask

TAVR The patients. first would be on for asymptomatic early

year when on there the asymptomatic then And findings will if data, of the Just get get where could at could a refresh average some TAVR once so be be or of opportunity. that wondering average centers, opening on up the end driver think in just study average significant high-level utilization And comments you maybe from on days, hospital sort you fewer number? the how a to on about latest with asymptomatic. sort then the existing And that next utilization, view we to -- influential provide the are today. how volumes of U.S.

Mike Mussallem

that's for obstacles of this the severe a early can misinterpretation. really treated important of One patients have what trial It's symptoms the a identifying So stenosis. And is the subject uncertainty not if is asymptomatic and to aortic then a sketchy TAVR have game. guidelines whether they're symptoms, trial. let say be to me start We lot there's that is very they with assessing they trial, think because treated

severe dramatically. out And we think if took be and stenosis that say, that take meaningful. requirement So diagnosis patient simplifies drives of make difference. It we some aortic treatment." the big That measurements the "Hey, would could has simply would if very and echo this it equation, a you

So we important. that's think

didn't Do saying it fully I understand. Anthony, you question, mind, second again? The

Anthony Petrone

volumes? number in today, average hospital U.S. where TAVR that does look there When the just is utilization monthly to fewer higher? centers average driver, Sure. the that average a When is utilization of surgical at U.S. days of potential terms in you have number volumes end as a move you think

Mike Mussallem

Okay.

be question it a add can capacity able to it So we've if adding We like feel not and been big that's do well. into routinely the them. seen quite they do and system, days. and found growth. to hospitals clinicians. that's hospitals them do that underlying do burden the by that new can ability adding They to your by -- come it helped that's we And They with have really really

their also, all to own so shorter is to practices. of discharge in able if to for helps that example, And able multiple but do, they're capacity. And say TAVRs patient would faster, when increase clearly the able it a are is it those generally, If helpful length And helps. really stay of that be is improving. desire I to just they're day, some their

more So far and hospitals' to getting becoming the past, we're been TAVR than it's that plan. helps predictable where it ability place in really a is had -- to

Operator

Maeder Adam Piper from with comes question next Our Sandler.

Adam Maeder

centers wanted theme. to are I just with of U.S. capacity we and the about kind new TAVR ask Maybe sticking today. where

would I impactful. open centers with of couple and was green NCD not just up? we're there And new we think starting shoots lot are some a in centers, quite span a the XXXX again that has then have just new Or see COVID-XX I new TAVR been optimism But hundred there if obviously yet? to a wondering of follow-up.

Mike Mussallem

Yes, getting get let U.S. centers your interesting It's is Yes. Adam, quarter. any even each follow-up in increase He's been the the for something questions. an maybe your quarter, there's But Scott me Ullem. XX I per here XX XXX we're probably lonely to pandemic, without over around to question. approaching hope centers during

gradually the We've heart you treatment And centers impressed who to structural during be actually able patients. increased. tells bring so that pandemic, it's these been their TAVR have about desire come to online to the

So we've been doing nicely.

of time NCD, XXX. We the update at this the on that have any at think the point. I might we don't thought number to really go

So that we are. maybe you gives a sense of where

Adam Maeder

really Mike. on follow-up but of to the apologies one Scott, And TAVR in That's things the helpful, pipeline. side

of Just XX bit -- it's little been update SAPIEN gotten think, time program. a on here, I since the we've an

that something move share plan? developments to if wondering there? to think any some 'XX. point pivotal planning you're I a you you just there's still that is in And can trial new So at

still that more case? about the set we feature the will just and product when learn is And design? So

Mike Mussallem

at line. Yes, more not the share prepared of feature the point, we're product about to Adam, this set

we're perspective, expecting although we're on really the just innovating. picture think trial still maybe we from We going begin with are where to even in And pleased XXXX. not TAVR, stop a bigger clinical I to are

regard. for better therapy to continue relentless We that and for this stay find it and make to patients to opportunities us improve just going in we're

Operator

UBS. from comes question next Our Matt with Taylor

Matt Taylor

things the standpoint, doing slightly, about Scott have gotten at guidance you curious, yet? caution? comfortable product Or from a better for but quarter out I'm why the try the here, abundance year just And -- just you one in year. by now Is more? not beat to I'll that one Maybe where an across point involved. under the turned belt? the don't that lines QX, you But had growth I of guidance least wondering, of that and are you feeling to card raise over have worse the better-than-expected feel with guess high-level get you basically I'm raised

Scott Ullem

of we're about we investor we better strength, quarter guidance would felt much December. And in all you our the where the both going back, and laid right how investor the in of like assuming in now and We we're line. we what still guidance the the to in out guidance look, we the conference to reason in pretty with for and it's that terms having in we guidance still get that been here are vaccinations said originally But got sales pleased remain through choppy. our at first the quarter, Well, was in and not on take it's December, since bottom things. choppy feeling to margin to But it the XXXX, has there's administered happened first be results the late why for laid of earnings gotten I fell remember for mean just positive out we although things confident that that open. the quarter, the the X seen out probably worse, conference. feel laid call It certainly confident when that of reiterating think And was we January, signs widely that of January, that full winter second in we quarter get our felt the we've first bad. through hospitals and months it year. and

Operator

comes from question Deutsche Chickering next with Our Pito Bank.

Pito Chickering

Mike, for One for one Scott.

one First Mike. for

seen you're the local diagnosis docs you talked I'm referral increased outperforming patients As centers drive any world within seeing recover about, any their of centers. with smaller if Have you channels post-COVID, curious larger begins to changes help markets?

Mike Mussallem

we've really changes in it's the think seen say meaningful not to I fair Pito, Yes. centers. referral that

though maybe this center likely patients distances and that One hear -- to travel their want more of and they're anecdotally centers. just to to to stay are have a long seen excellence, we local less we then things the is to likely of

so some pandemic. the been in probably And probably to of during behavior that's driven the some extent, there

Pito Chickering

I to if travel as throughout recovery how impact Fair year? cost increase And But get up to pick expenses again begin much as revenues and Okay. conferences you for here. will will travel quantify the enough. then Scott, begin conferences the generally can

Scott Ullem

that are is enrollment continue not out other just person. up statement. and to is a field; the development training, on to meetings trial and more on actual of our in drivers income of coming item clinical two of different more the the person couple travel number people travel there line expectation increase. we're time our in in expenses clinical One expecting going those then, And course, going in the expenses, a extent We're that to That's and versus will Yes. society increase. that but down to break our shows trials, that research more start expense now

So those some are rest of at that be of least our the pieces XXXX. will in expense the influencing ramp overall

Operator

Bedford Jayson Raymond James. with Our question next from comes

Jayson Bedford

No Surgical. I one's there's time than asked TAVR. about grew strength remember comp I realize last dynamic, can't Surgical And but a the faster in

you out questions by any just versus assume mentioned growth international from And we a Were of markets? was the that strength growth? parse orders premium dollar Can products. couple that. impacted of helped way to most So there on stocking was also procedure Any growth? growth

Mike Mussallem

Yes.

March. pretty dropped in precipitously late Surgical So a things. you're rates right. few One is,

some a comparable. So that of is

So should comparable, global quite account. the that if was into go stronger slightly But U.S. was certainly strong. not actually, the than It rates.

ended was And was the so certainly know up but that the answering question. I don't good. think it if And U.S. I broad globally,

Operator

to questions you. we all have I turn time management floor today. for Thank the will That's closing for the back remarks.

Mike Mussallem

additional And questions and welcome thanks Mark. I for Back telephone. you, by your Well, in much continued all to any interest Scott Okay. very Mark Edwards. and

Operator

again lines This (XXX) participation. XXXXXXXX. today's Thank this call, XXXXXXXX, XXX-XXXX (XXX) use your ID once a (XXX) reminder, once concludes dial and or can and you disconnect to XXX-XXXX conference, you access the for time. again, of concludes this is replay today's And you. Thank XXX-XXXX, all just you conference. a your at number may conference conference ID This

Edwards Lifesciences (EW) 21 Apr 212021 Q1 Earnings call transcript