EW - Earnings call transcript Q1 2024 | Edwards Lifesciences Corporation

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Operator

Greetings, and welcome to the Edwards Lifesciences first quarter 2024 results. [Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mark Wilterding, Senior Vice President, Investor Relations. Thank you, you may begin.

Mark Wilterding

and and Diego, for you lot, us. joining a good thank afternoon, all Thanks today's our call and on me With is Scott our CEO, Ullem. CFO, Zovighian, Bernard be portion Also Structural and TAVR Heart of our Wayne Heart; global Syzman, the the Markowitz, us our Structural our Global Q&A and Chopra, Critical of joining call President Katie for Surgical Care. will Leader Surgical leader Larry Daveen of our Wood, Global Leader of of TMTT; Global

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

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

not management longer undertake clinical based fluctuations. be currency Edwards and statements date which and approvals, they trials, assumptions were opportunities, of limited note them forward-looking statements These statements guidance not obligation are matters regulatory reimbursement, These and will the litigation, and expectations only as to, after on today. on any that foreign made, to update growth financial for competitive estimates, that speak are projections. Please but does making include,

that website the may SEC filings, the cause important and other of involve release, that factors could all are statements annual XX-K these actual to be information differ reform Information company's concerning product press on Additionally, differences results safety found in and XXXX uncertainties our Form Edwards' and available materially. cause risks at could the edwards.com. on which

numbers call included Reconciliations press between which Finally, issued today. press defined and quarterly growth today's to non-GAAP in release unless refers constant currency otherwise noted, is in mentioned sales are growth, commentary our release. sales this on earlier also in GAAP the

like over for turn to comments. to I'd Bernard? Bernard call that, With his the

Bernard Zovighian

Mark. you, Thank

XX% We $X.X versus are billion year to of first company growth with ago with period. pleased the performance sales total our

to to XX%. XXXX end are result, the our set a As we high raising of X%

transcatheter our of strategic the investments well to some strategic to deliver company. extend made grow growing perspective remain we term. and platforms positioned about and and over large look our the opportunities to tricuspid the by direction of we across impacted share ahead, the I'd aortic, our long driven like leadership patients to mitral disease. many Edwards We have TAVR As the confident is growth, by address in sustainable needs

increasingly this In expect will addition, becoming to TMTT we is contributor growth, an continue. Edwards and significant

An valve important innovation advanced is technology. our in leadership our tissue element

We of ]. more is we [ with have are been lifetime with a advanced innovator focus years evidence our on pleased serve. latest than and comprehensive technology management of [ With for differentiated durability, technology our RESILIA a patient portfolio Ultra an X in we across ] tissue XX SAPIEN used

of will XXXX. are benefit patients that end We pleased X.X tissue the from of by technology million this

remain and highest heart, advance year, meaningfully science leader This clinical in multiple significant As to evidence, trials on are physician already technology and world-class bringing key we and we structural making improve care. progress the next-gen the global groundbreaking committed deeply support technologies. to patient

quality only in pivotal a milestone ] an in stenosis. a shown trends clinical also to population ], moderate FDA aortic with In U.S. stenosis is transcatheter EVOQUE a achieved failure therapy treatment options hospitalization. improve EVOQUE treatment treatment aortic regurgitation. potential to with mortality, of important reintervention groundbreaking be have receive patients, approval patient and but the to of the life the [ of studying February, as not patients tricuspid trial heart for we the treatment January, completion progress all-cause that first severe favorable [ twice the became large In of estimated

College the earlier prevalence demonstrating large in initiated treated with And at the Conference, for access ] valve the Alumni this identified barriers patients is announced results to committed dismantle excellent we SAPIEN Edwards Hurdle XXXX partner to that to the from we the data [ for NFL our known ] American communities study the Health, disparities status. at and of care. studies real-world from study annual Edward to X [ March, among announced Cardiology socioeconomic continued structural with In Edwards experience compelling helping by in of examine undersale due groups month, to platform. race, and Conference, gender at outcome heart historically access are CRT disease

and through care structural Each of transcatheter-based our growth commitment our advancing sustaining intervention. reflect to strategy in reinforce confidence these deep of our heart patient differentiated the

first quarter Now $X increased I billion, days. $X first clinician testament first product global Performance Edward's our year-over-year Japan, increased by In U.S., stable. for marked currency technology. by an year-over-year driven in TAVR will team prices global provide was position U.S. QX adjusted was group. progressed. TAVR, quarter additional were our higher was growth results sales total growth Edwards the We exceeded when the the TAVR milestone billing quarter a competitive billion exciting and and rate to quarter our QX X% our volumes of on both than Procedure sales leading growth in as confidence constant sales that detail some estimate rate. selling growth stable. In the procedure and for

X than innovative sales robust performance durability. build across the of now continued that tissue in This centers. best-in-class pleased outcomes which our Edward's in the our technology of remain leadership RESILIA, up the makes the work TAVR on SAPIEN We Registry excellent U.S. more for of TVT Ultra with long-standing and real technology This platform is hundreds demonstrated in XX,XXX the by data patients majority supported platform.

is The of as patients expectancy. the technologies feature important with longer life to a increasingly be designed therapy continues that a valve, will tissue treat to extend durability treatment optimized

our proud and also patients continue AS to science trials. progress for the We commitment to are deep early TAVR advancing through

in we enrollment completed of X January, approximately in treatment and patients discussed years expectation. As of progress,

evaluates the is asymptomatic to TAVR of significant also to on expect the while We at trial AS. for if the patients. the severe streamlining of a on most of severe ] the early referral We [ compelling, Symptom believe barriers ran this impact TCT TAVR one care release to year. and patients also results data have TAVR are early early may treat all TAVR Conference patients deciding and AS patient meaningful impact with when assessment

the to results our the expect of expected growth offset U.S., In in slower-than-expected growth TAVR growth, constant rest in growth partially in global strong of first sales QX. softer and was currency below But quarter, the Outside normalize. Europe. full XXXX performance than by slightly was our were in year TAVR we our the world Japan

and of Ultra into we for in European the QX. preparing actively X launch introducing SAPIEN market are technology We the the anticipate in RESILIA Europe,

to elderly TAVR continue by expanding AS remains we on Japan, and therapy. to ability focus disease adoption undertreated an In the substantial believe RESILIA. SAPIEN We see among of evidence this continue population significantly strong the driven X supporting Ultra a

growth are Edwards through future, of sustainable healthy advancing for investment deep patient commitment and into technology TAVR well confident that initiatives. by In positioned driven activation high-quality in our clinical element evidence care to and our is we closing, the differentiated TAVR our patient

AS in groundbreaking of patients our growth Importantly, TAVR sales research we are are fundamentally trial, proud our XX%. how early could PROGRESS of remain treated. and AS into through confident the X% to treatment We year change which full our TAVR of

second second expect higher than in year-over-year We rate the growth half first quarter. and

We system. and unique broad replacement the Ultra therapies SAPIEN [ [ replacement system in ] advancing significant patients. including our RESILIA system, technologies, with portfolio the PASCAL and ] momentum repair Positive for and both TMTT. wider pill X and replacement strategy tricuspid for mitral progress made important to EVOQUE the Turning

improve We patient the approved are and only backed with evidence care. therapies company tricuspid world-class multiple to mitral by

QX, expanded site positive In results by of the adoption with majority and new were we The activation double-digit market XX% PASCAL representing year. the supported by sales of a versus $XX U.S. prior sales and continued tier driven increase Europe. growth QX of in achieved million,

the physician feedback ] also [ Europe. excellent faceted We the and both EVOQUE, with are strong pleased and procedural in U.S. valve outcome with

demand quality is large patients in life patient With indication improvement EVOQUE mortality technology, therapy tricuspid need see favorable unmet to very this clear this The population. for of physician increasing unique treat failure and for the the replacement significant of heart potential regurgitation, a for and and trend specialization. all-cause we a of elimination

in organization to continue support achieve for therapy to excellent each order outcome to to globally in We patient. invest this field continue high-touch our expanding

full strong adoption the Given TMTT guidance million the and raising higher $XXX million EVOQUE, year our to versus million of to $XXX are end $XXX we range. to differentiated which technology, PASCAL was $XXX million of guidance, previous

Edwards overall both with for and therapies long-term that repair portfolio for clinicians options offer global and effectively an replacement contribution set in increasing We growth positions need. sustainable of the are This tricuspid and patients mitral treat strategy many broad necessarily will strategy to to our us leadership, confident unique growth.

Growth quarter first strong [ million of prior increased was $XXX Connect by over and surgical Surgical, MITRIS premium global of the adoption Edwards In driven ]. technologies X% sales INSPIRIS, year.

to continue positive We the for treated complex many for patients, growth see procedures. globally surgically, including undergoing both best procedure

expand expect trial the X be Canada clinical expectation. now in and our studying QX to U.S. to in and of completed continue of and year ahead performance body the in We valves evidence of XXXX, multiple multiple oral mitral Momentis technologies enrollment RESILIA position

Latin study, The in open continuing new to America into we'll global with Europe and continue sites enrollment XXXX.

mid-single-digit now guidance expectation growth. full and to of raising sales are our to X% surgical X% year We versus

our and versus quarter the sales devices to was IQ of our In year, recovery driven strong prior from Critical sensor. ] product by Demand pressure Care, XX% used the also $XXX ICU. monitoring variability in million smart all for was the transcatheter led lines. of increased first including contribution which technologies, led fungus by demand Growth Acumen [ better-than-expected

growth Critical designed to focused clinicians decisions and are make get recovery family help driving faster. and home expansion informed patients smart more smart Care through their remains to which on

the dedication. all Critical to in significant are raising guidance previous hard growth. mid-single-digit progress, want I thank team our has of and made work our year sales December, X% of to and critical We expectation them Since versus XX% spin-off full announcing to in confident of their now for Care

details. will And to Scott. call Scott turn I the now over will provide additional

Scott Ullem

a and Thanks everyone. Bernard, lot, good afternoon,

our performance total sales company on mentioned, we are As strategic progress milestones. with Bernard and pleased our quarter first

In we achieved $X.XX adjusted addition, share. per of earnings

full GAAP our our release. included and Critical Care. adjusted for share $X.XX and onetime is of other with included earnings GAAP today's per Our reconciliation with expenses spin-off planned A between associated this items EPS of

sales our adjusted $X.XX. projecting and we're to P&L. second I'll cover billion per to additional details billion quarter, $X.XX And earnings $X.XX now $X.XX of share the of For of

the In margin the This more foreign impact expected in year. from to driven was prior adjusted exchange in XX% period last compared year. reduction a profit was by favorable our QX, XX.X% gross same year-over-year

expect technologies that high-value be to gross gross XXXX full We continue adjusted XX%, between by yield to profit driven and margin our strong year XX% margins.

$XXX to This million quarter administrative an the the general driven Selling, or prior ] support of was XX.X% field-based were of year. in compared extended strategy. by our in expenses [ of and million in transcatheter $XXX personnel sales growth increase

year of initiatives. XXXX continue SG&A and in we percent approximately We patient be as expect to sales XX% field-based a full activation to personnel as invest

Research increase and year sales. investments of transcatheter development expense XX.X% increased or over million our of the the in primarily X% innovations, clinical in result to trial continued quarter prior including aortic grew first $XXX valve This was activity.

continue generating XXXX, treating expect For new goal evidence sales XX% to with of we and developing for we technologies even the to initiatives, to structural the our as be of heart XX% disease patients. invest full in R&D more year

taxes. to Turning

Our impact of [ items XX.X% the excluding was reported quarter this or ]. rate special XX%, tax

stock-based includes quarter compensation. Our non-GAAP first favorable the a from higher-than-expected in benefit rate

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

decreased first points in sales or XX to million growth by quarter prior the basis reported rates compared exchange year. Foreign $X

now $XX points impacted on compared sales the gross first prior full per earnings negatively quarter quarter current negative January million X% versus FX rates or XXX impact year. had prior our to our guidance, basis a share. rates, profit nominal FX we margin impact exchange rates At Relative Foreign year. the a XXXX to to first by year expect

ruling by statements Regarding are to anticipate year-end. from the and financial tax-free the Care, obtain the completing preparations we previously announced spinoff next Critical are track IRS unaudited We month carve-out on ongoing. of a

company, to plan details we We for are investors with structure currently year. the assessing and spin-off capital options later share this

first the spin-off. we the $XX million quarter, incurred of costs During onetime associated with

XXXX. of the contingent throughout million tax for payments incurred of be quarter the first will resolution spin-off associated $XX deposit reduced costs onetime with Critical by Care. a million of flow the was cash a dispute upon $XXX Free and Additional

cash grow flow full and Excluding the impact of year expect free these adjusted adjusted million, items, we to billion $XXX to cash $X.X and XXXX free flow was between billion. $X.X continue will

sheet. I'll on finish our over turning to Bernard, before balance with call So an the update back

to investments continue of of strong March in approximately flexible cash, a maintain equivalents as We short-term $X.X and XX. billion cash balance and sheet

million XXXX remaining be expect to repurchase million share authorization. between shares and continue average our We outstanding billion $XXX $XXX to current of diluted under $X approximately for

over that, And I'll with so pass to it back Bernard.

Bernard Zovighian

you, Scott. Thank

off driving growth forward to important outlook as in year start launching are We and strong to and XXXX in progressing with patients future. innovative look confident aggressively investing a to we We're focus our multiple We technologies. technologies increased worldwide helping and remain clinical even on the breakthrough with continue trials. our financial more leading

In closing, believe the tricuspid needs Edwards by heart aortic, mitral our by structural to we growth to on address positioned impacted and large is investment deliverable uniquely focused of driven disease. growing significant patients

open that, up Q&A. Mark With I to it pass to back

Mark Wilterding

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

please answer of as management participants possible queue If remainder have the additional you as will questions, the call. and reenter many during the

details Diego, portion ahead with Q&A the please the accessing go of call. additional on

Operator

[Operator from And our Instructions]. JPMorgan. with first question Robbie Marcus comes

Robert Marcus

Two TMTT above a had consensus and wanted in. numbers really Great and come strong on to quarter. It hearing. for a in congrats the I EVOQUE. some came start with optimistic of me. was well I first most Clearly, quarter nice

to you're raised was the EVOQUE. of the what of is I get seeing, stages adoption much So sense early here. how TMTT And of you guidance. this clearly, imagine I just wanted a

Bernard Zovighian

This Robbie. a good Thanks, is question.

early We very able very been outcome. which to physician an pleased we were has very, achieve EVOQUE. So are on procedural the strong excellent obviously about feedback,

very your back performance to about EVOQUE. little question Now QX, about in our

We adoption ask add our of here. a details in about But to PASCAL we PASCAL on to globally momentum And I'm very expansion Daveen have PASCAL PASCAL, clear seen very U.S. in going Europe, pleased basically. the and some are

Daveen Chopra

into we from up overall, Right U.S. Bernard's is the much, [ the to in we good obviously, so saw though, obviously, see really with And very and question, and comments, for had Yes. We've now, just clinical ]. And outcomes, pleased vast procedure something our we're clinical that, steadily the came with physicians what we really consistent both trials And of PASCAL, in kind as Thanks that see sites. up sites that really Robbie. of in We old both follow majority we've that launch is in predictable just well sites EVOQUE really times trial. be to Yes. of this love kind continue see. to we're initial the Europe. starting of opened [ predictable at with activate new Europe Thanks times the or Bernard. ] as to growth new

and so journey, XXXX want patients where comment both especially the so The we've for replacement I'll of our because portfolio diverse. PASCAL early in tricuspid had fact experience technologies but the complex it's reinforces only is have repair since are our tricuspid a really in Europe, really make we that and approved thing need or to

So I'll stop there.

Robert Marcus

caught global comments rate TAVR TAVR that the procedure throughout organic that the follow-up. quarter. Great. the I as growth grew faster Maybe U.S. than accelerated a and the

So And about after like thinking years you for the some how you has of rest of do finally the year? facts saw TAVR recovered feel COVID? growth you the during U.S. the of disruptive are the

Bernard Zovighian

Robbie. Thanks,

start, insights me Larry some ask to again, Let add here. and will I

X% guidance knew year to together our the be the with QX year, will a that quarter. that ramp growth throughout the lowest XX%, So for put the growth when we will guidance you, we and

the what's feel and price stable. confident about to are about our We share we So X% happening XX%. in confident U.S. you're feel

all of So we about that. feel good

want you Larry, anything? add to

Larry Wood

year. lot in the little of good we pleased remain the are slow as quarter. the out with we excited add. we It's but to don't And progression come a throughout have the We January always I a overall. how quarter break, saw Yes. went about

We have patient activation. a lot activities of on

say, have say inform how see the what huge us field. data out all TCT to are We of those that coming a excited think they be set that data I to going of what and

U.S. think, out with on of And believe patient just long kind a it the have good mirror, can runway I I continue to and accelerating COVID, focus see long rearview to TAVR the so we is we in finally and term care.

Operator

Bank comes with Travis from America. Steed next Our of question

Travis Steed

Congrats were And growth why lower expected. quarter. curious again, any billing a TAVR OUS European those quarter? was U.S. on those good days, and then the on than Maybe on or in back come

Larry Wood

with overall U.S. Japan, lost of thanks. SXUR sequentially, expect were that with disappointed Europe excited lot led technology I and pretty Yes, it to billing felt saw strength good aggressive grew launching We growth think the we some that quarter, little some bit Yes, to saw starts trialing. of overall, year. to days. in we and our to a we talked we're about this -- we the these excited pricing in a Europe. actually the really through even and that But month, We grew normalize course it that just from the but that, was couple and a Europe, we're about of But competitors we're and we year-over-year bring

Scott Ullem

a can on I little give more billing bit commentary days. the

and days the saw outside we really we So saw felt is We of billing where day in X X Overall, U.S. difference. billing Japan. difference globally, Europe it.

later it see in And about direction your other well. the goes impact. that any more To days question do impact year? a billing had as we've the in QX, an impact so we Yes, in got

Travis Steed

programs those TAVR doing diagnosis. on with All kind growth? of going been on that's impact growth -- how TAVR out do you point impact on see kind helping and that and the see of Curious of to start and Egnite right. what And and then an at and That's some scale you've center to helpful. drive

Larry Wood

Yes.

of lot we a activation that do. a activities where lot of patient have there's work We

spoken guys should. identification the before, you part he's the through But system at is just in one to multifronts and publication, think you We aspect. moving speed Rayro Family a which there at what ] they And many there's these so upstream referral of a And about just our strategy [ aren't patients Egnite know of there's we're have if aspect, are can a there's excited technologies there. patient patients, that do. I lot the I and look

growing. that have as And understand we I undertreatment the more think understanding work to our working problem, the of on it and this. aortic magnitude So think strategy But I the multiple gives people hold. appreciation think and for start I activation the opportunity is streams of patient grows to take for

Bernard Zovighian

And addition, proud Larry, what in maybe about are very I'm we doing.

are We only patients through trial. the AS early for to commitment science the a having deep progress and one basically advancing TAVR

is feel we ], potential. this committed are underequited but a these patients to underdiagnosed are we [ treatment So is patients. truly there that These our and commitment, ton of offer for

all do So a proud as we about very this. of company, how

Operator

Biegelsen And our comes question Fargo. next with from Larry Wells

Larry Biegelsen

be Robbie's are do one second growth I confirm, had half? I you And QX. just you the And QX trial expect why I SMART question. accelerate to Bernard, how to In than TAVR, TAVR wanted guys And response wanted on in TAVR in that better to growth the will results? factoring follow-up.

Larry Wood

to QX patient of improve, we the always We in we're to I expect we of it's have market also to Yes, with that were and we things, if Larry, work. just ramp our But last And so lot our pleased continues it's to do a and QX. to think year. I finished happy a the a happen. it's been ramp. think activation very continue expect Yes. plan, lot of part That's procedures

do we growth think QX. have see to the higher expect with over first to second half that, even the an half. But in expect we QX rate increase than I So a

that think So good. that's I

lot it as mean, trial, a at And to about relates SMART the we I ACC. it talked

I reminder, the point. It's think about data just never but what to about a and about criteria. never X on It's talked we've valve X is before, it's multifactorial. this decision been use been

model have And our about technology competition, in doing and we RESILIA our confidence leadership. but other feel that always platform our platform and continue all proposition Ultra in that things our so the and to good the we we very and with value we're

Bernard Zovighian

being me, at know plenty But was it. potential, So about let at to evidence our not there of being help X basically the is of something quality me doing. Larry, is that who This tier unlock were today trial ACC. ACC. let groundbreaking science, I our are bring highest what market to this able strategy. we add of questions I strategy patients over million to large treated that this about are and not

So in of FDA-approved XX the a the you well. severe into across today, patients signed TAVR research symptomatic AS only we conducting again, studies. are last XX,XXX And the early aortic very know years, us through mainly In we treatment company groundbreaking progress.

I a So about in leader you proud tell disease. valve mitral again, as [ we can ] very I'm who are

with than I think in an the is interesting ACC it at SMART else. was anything no, more mind what study, my happened but

Larry Biegelsen

I Scott, correct, Why but saw EPS guidance. And that? not the you revenue is change raised you guidance, the did

Scott Ullem

rate tax a to of lower going to We we first couple right. we reasons. and revenue of our expected. low that's a be rest with Not in the maintain kept that same. this year. range $X.XX you're nearly rate million, Yes, quarter ended was One we we're $X.XX that of to sure are a than brought able the up up There tax $XXX guidance the right,

The year. other early is the one in

EPS just We more multiple different this X talk decided out think that is trending year, the But so the in end range And same. the of at can play months keep point from rest XXXX. could we'll accommodate it about early in we we of top now. how the scenarios the

Operator

from Matt question with next Our Jefferies. Taylor comes

Matthew Taylor

you about importance the and Great. a question the of portfolio. TMTT Thank talked this I want you. did ask more specific about to performance,

to way as approach tricuspid to more performance helping a was through across you to guess guess, use even able or wanted gain that even of and of EVOQUE, time more you to And And first share. I ask that mitral portfolio is PASCAL? the to the improve be pull was, expect I portfolio go so you I do through

Unknown Executive

answer that. I'll

Daveen Chopra

you product portfolio PASCAL. this answer then No, really if and EVOQUE our of look significant leadership kind for X, think But that. any by at the up, back us patients both was Daveen. is Yes, tricuspid you in think to honestly, no, I versus us as if and replacement from pull-through having that space. having there I to I'll don't and pull quarter number of our would continue want to technologies physicians show work treat repair mitral maximum the help with leaders direct

so there's a always right, I what's up happening at look and kind going new continued to But growth be if think growth open of we PASCAL, when at opportunities QX, for link of overall, centers. in way. to look that we I in continue kind

work way, We in was that the we which continue deeply to continue work gain with that that with I grow physicians to we and -- in centers think more fantastic.

will Additionally, we future. think continue into that quarters the for going and

continue the stages time. are where initial PASCAL bringing we world new to we'll we're Additionally, grow where the the for in kind kind geographically, also first just be right? of We're in There PASCAL. of the of at countries

all the can market, technologies these SAPIEN growth a and board. mitral the EVOQUE And of future. then right? in bring -- role that's future, will number really also ] talked valve transcatheter another for that think an a across PASCAL then kind have. layer think to we provides And will together So runway MX of to which about having [ we the that's important for two leadership growth be then we've clearly, us I And of EVOQUE, opportunity. add MX long being We going our we the see

Operator

next Our comes question Joanne with Wuensch Citi. from

Joanne Wuensch

as the growth to saw that revenue segment. want I to XX% quarter. what own, out go wow. sort it? some I Care. that sustainable time can't propping is drove of Critical nice spend on How Very in last time And particularly a And its remember growth? I on it's

Bernard Zovighian

want Katie, do to question? another you take

Katie Szyman

Joanne, Thanks, the question. for Yes.

for part you capital of So we mix. have know, ] [ the as Care, as Critical tools

And so we variability lines. our high quarter all every demand of really across just product see

up distributor and come that can have also sales down. We

for in us great a So early still overall. it year. quarter was It's the

much to because in that us So saw just very to to guidance up that we point of you raise X% XX% we're But too demand. confident XX%, X% want it to at this don't range. bring in variability and more

Joanne Wuensch

] comment during that January tight from Or just profitability the we can [ you quarter? should hang one? on

Scott Ullem

Profitability for the company, Joanne?

Joanne Wuensch

Critical No, Care, possible. if

Scott Ullem

helping off product profitability. line it top a bottom on line that's quarter, to was as our Suffice well. hold good line and it Let's say,

Operator

from question next comes RBC. Singh with Shagun Our

will to our next We Miksic from And on next question. comes move the question Barclays. Matt with

Matthew Miksic

question and X valve just sort and on Just I'll transcatheter growth, TAVR to of one. it keep

or they in maybe your drives in If the TAVR. centers. in levels managing launch I and talk those the that that of volumes some that, bit field about ] perform little kind the you versus could activity EVOQUE and team how major of you a And the [ activity -- is the guess transcatheter of you're centers the continuing

that into business? how any transcatheter the color thoughts play maybe total on might or Just

patient field And if to on year. are this, and but and SG&A I this willing then you've impact on that the you've you you'd know about that resources planned the mentioned of executing be resources activation if can Scott, do quantify don't possibly sort

Larry Wood

Yes.

then sorts and what people sure do roll make Matt, to it want start, We partner I'll these it This is that therapies, kind and Daveen. Daveen out with right as do I'll of new of closely we like very day. to over clearly, we every So volume. things. hand on I And these the

key entire it's have a population. centers, encompasses patient their whole they a that when of heart that And we program structural maybe so start part

together. closely work teams our so And

This doing it. dedicated related it been want to environment have We launch Daveen that But Daveen? and still have we've I true it there, detailed PASCAL the because very we is a of to requires where all and we this bring unique things teams of lot procedural the of a knowledge and coordination between true knowledge and this for boat. a remains while. and is with

Daveen Chopra

and Yes. being in interior relatively -- mean around just repair, to ties comments more some maybe The [ procedures. grow asked, mitral is these years of technology right, being for The the with for that's I'll is question add mind quarter in of established ] you just about been I capacity and kind the maybe large, several number patients more rally the you and right? numbers treated. very EVOQUE kind of of X based on patients and small more treated that future

a overall, procedures believe future going Larry's carry time But and that well the we're for ] to time, up together the to to very are So in we're also have that then to that for capacity capacity. in ensure us, procedures. -- first working near don't ensure center affect incremental point, center do necessarily working with that EVOQUE we they overall the for opening on I when to add I or do center to these collaborate any the with [

Bernard Zovighian

is to is to TAVR whether the far, challenge it big terms patients a center in that fair have lack faced patients, of a of having or be to so capacity EVOQUE we What patients. not say able treat

Unknown Executive

[ EVOQUE patients. ]

Bernard Zovighian

[ EVOQUE ] patients, yes.

Scott Ullem

about your Scott, Matt, And SG&A. it's question

resources initiatives. investments original that heard remarks XX% top a be based in to expecting opening access was our move end sales increased us and percentage making of to the You say of in largely as up of XX%. range bit we're the upon that that the And a SG&A field around patient we're little

we're move beginning the also gets been these to sales didn't waiting EPS initiatives. move Biegelsen's investment upon deciding moving to how earlier of quarter here And that's how to we about why it based kind those, up some outlook. sales, of go trended some range before We've year at And with see up spending our aggressively of forward after question the reason guidance Larry and going to first the yet. we're we of wanted

Operator

Capital question Markets. And RBC Singh Shagun from our comes with next

Shagun Singh Chadha

just like It drivers the that single you future? growth double-digit digits. about U.S. Was was XX%? confidence can high your sounds Is TAVR in other it Just that And Sorry fair? about what's get there? consistent to earlier. growth foreseeable

And initiatives. to [ your take get wanted they're like ] seems centers. noses expanding on additional aortic It to then that AHA's I to

impact TAVR have suggested that checks that, our volumes. of some And positive a has on

volume So just to potential and that the on TAVR. anything expansion you can scope program, of impact share

Scott Ullem

about you faster specific first in growth. to TAVR the that first region. rate we Yes. take the grew do talk not down about the TAVR that underlying We try But breaking every our I'll number what other for than the global Larry, U.S. is say quarter. to want of growth too pieces? can about part be U.S. in

Larry Wood

Sure.

that. program, ago, to that AHA analog time. we're And dramatically, drive rate partner excited And was and faster a a an that having on across AHA on the is they looking do this. get for balloon the and years survival critical based metric years patient door-to-balloon it's a quality MI, lesion, they an you're rises So know we with whole they when created very where the the because that the

disease, say But gets severe and AS, for have before the the centers to any the the clock heart trying start echo of ends within that from initiatives part of a that actually diagnosis. work time And the miss From the on journey first of we treatment. do the upstream to they they pretty team, patients where metric got have is do quality sort like really that time they time the patient will story patient every to don't heart XX And door-to-balloon quickly. a up with we're most has sometimes I days it treated team. to long there's referred diagnosis around patient get the when But is think the that they component.

and they're out say. things move job the think It to centers does the they're it well back of first can deep actually urgency around would that we But one through would were. centers find what when be quality dig have get on. quality is own to most And it implemented, find their would at metric And they completely good change doing patients they then they look their own and near if not the metric go and they data a data, this system. as gearing they thought have as report a

dramatically where mortality initiative these centers do very we to to care have we metric wait could be well. report have make improve but it real think quality would high that, know we is because we expand goal They rates. So on part And the not system to guideline continue or it. this the of do AS patient a patients

when in untreated, patients, higher had left mortality process. very rate back Part year all was the they If the a mortality the and way which to rated quickly XX% X, you a go that risk starts

and partner put with expertise AHA, they place. in of to excited demonstrated things getting partner because very us in we're they're great a sorts for have these So

Operator

Our next question comes Research. from Chris Pasquale with Nephron

Christopher Pasquale

do on a for make think you're factor the commercialization? kicking other next is see gating a to nation can reimbursement you Or [ October launching Do in? months EVOQUE, you over that progress in First significant technology the prior out incremental pretty premium meaningful price you the ] to X there.

Daveen Chopra

Yes. Appreciate it. Yes. Chris. Thanks for question, the

patients key physicians So their believe We of we've first, increasing care think comments. clinical technology offers factor. both that's economic really have patients. EVOQUE to benefit seen this interest and a just to to systems. And great from and a a and health exceptional couple We demand help that

quarter going we're continued centers results, continued and [ kind opening up growth the to ]. of So I think each patient see

If CMS you that said, were to proposing as site we is expects, then that think TEER. for And procedure move which that incremental And about start helps versus ] forward the that NTAP, EVOQUE between actually that X. October the you and [ up any TAVR hope is cost mentioned you DRG, with NTAP, with NTAP. of DRG make cost the existing to

system much well will between interest continue transcatheter think that a of technology as does we we this think see So add so to it. to to patients. for physicians from But continue that and we now lot because

Bernard Zovighian

have NTAP Probably and impact next a after, not fair to necessarily year. will this big say but that year

Christopher Pasquale

technologies from purposeful both to the mitral mention of repair is there consensus going early patients tricuspid How today you then might completing closer for be Class EVOQUE and term, which [ each as about are thinking to by EVOQUE PASCAL longer how that gets way. and sounded Okay. both And seems lead replacement what enrollment. replacement the ] the fielding and physicians best be like tricuspid the TR a technology. And it to and commitment served and tricuspid, for was means then

Daveen Chopra

Daveen a number of we valve These maximum one. that on heterogeneous. that again technologies. [ There This for a bullet. disease are have believers ] helps that patients repair Yes. There's both Generally, comments on types each these couple to replacement treat the one of really are lot of states yes, continue and technology patients. this and of is patients need no different are

to continuing I today? a we're No, think and all some ideas, medical on of us, have product which the all the we ourselves, physician but what to replacement we have and patient. clean out it is figure Do so. answer work right for repair work continue definitely community, committee

all clean favorable With with TR, of like big technologies like this And along hospitalizations, we that right, see times. EVOQUE, predictable these see we quality of very heart cause of a unique mortality and very trends failure procedure, elimination life kind improvement.

Europe to have a -- couple for PASCAL segments ends already [ starting certain a PASCAL some now where the love it a lot of little a of we're where starting for of patients. there really feat PASCAL In now, But to EVOQUE people are physicians tricuspid, cetera. makes years in ], ] great has [ we have really tricuspid for really how casting valve, traumatic et see their Europe

we the patients, know out most quite mix really for the both these So exact figured of but patients. treating important are we haven't no,

Bernard Zovighian

something And X, and are repair patient. select ago, for for it a important. to X to this add was many what confident replacement I to having therapy that is both indeed and best physician about the treat and be options will going years what believe tricuspid Maybe patients case. mitral we provide we will that Today,

And need put in So for times, asking large to to We patient, this we more going in basically for what we decision which best portfolio what going TMTT driver a is But still that. is more exactly are you're I if years seat growth initially. result, as the opportunity is think this early. technology unlock wanted a this and research I it come. that patient, the sustainable physician a sure, still do see -- to to we from make probably think very their for to a

Daveen Chopra

right? like II Class up that And it's we your it I'll to of comment about TR. that's leave clinical the important why And continue data, trials kind in on enroll so

randomized trial, technologies different tricuspid our getting that's right? can a study super understanding really It's It's for ourselves. data how So important these patients. more where help in

only best post-market are continue other data pre-market EVOQUE to understand not studies studies, patients. So but can collect randomized this these to for where that technologies work to so important also for these

Operator

Deutsche Pito next Our from question comes Chickering with Bank.

Pito Chickering

end until to ready by X% the sure want [ that A And follow-up guidance heard centers sales your you to how previous to date? the the ], G&A, of many perform kicks expect that I with Chris' to be EVOQUE in just NTAP that high first. question. make at I limited procedure will

Daveen Chopra

this So Daveen. is

NTAP centers. now, the up On we each right comment, continue quarter, believe new we open to

in more We patients. this And it, continue the lot technology it's growth a for a patients. on to physicians and to steady technology for of physicians train demand state, from nice these providing we've seen

support Bernard's I point, will part missed of the really growth your that scale, of second to more question. help a XXXX question was second to continued And adds I gets -- NTAP as think allowance and then it XXXX the growth.

Scott Ullem

we'll And is, do certainly, how say once centers procedures I the do trialing what we think strategic clinical can active. where was going I beyond think been mean, ready I about activate activate. involved many deliberate be the NTAP just that. you sites going to is have we to that think question the be to are and We're in to be ready

Daveen Chopra

And that the tricuspid up, their their we're higher-volume on have infrastructure going up. centers imaging right centers are that side to have focus set already set

just [ centers to moving to a kind be of tricuspid ] of going it's and steady tricuspid other high-volume both So centers.

Pito Chickering

today? any, treating is docs [ indication, approval, systematic the exclusive to And trial if positive the patients FDA if on to on is any be And Okay. much color seen, that to ] you've that for going get in creep asymatic SAPIEN? how

Larry Wood

none trial yet. the Well, this year. until results That us of later thanks. as know Yes, happen won't

from I key the more FP thing. that be positive. the for is, going trial that, I it. referred you benefit [ about to that's think obviously, more the ] And So how positive the But is really patients get think get it's therapy. trial And

referral for stenosis that the frame in the treatment aortic we to So more it and do time specific should speaks therapy. a I than think

against the that a it is SAPIEN being Now platform. trial said, randomized

had And going You're we you're outcomes, rates. look trying data, our low-risk have if is patients so treating you those about only more survival we're rate earlier, We we complication towards population think years be PARTNER to our patient this that because, have survival asymptomatic, [ platform a platform have the low where that's delivers think in to more point. going is if trial lower-risk investments population. to line rates. XX% in probably [ again, one XX% mortality year at at make with to right? you're to really the And ] III outstanding clinical and would rate And really ]. this patient very going X a had And the low that at,

the but speaks -- to disease, I it of do Robbie [ deadliness So ]. think the

Operator

comes Our question next Truth Richard from Newitter with Securities.

Richard Newitter

is it more there recovery Europe business. -- price back you your for in And -- that you else trend visibility and to have offset to gives you the going what can is region, that you us it Going acceleration? ] your guess, and Brazilia will the comments there? a tell there and think that's just in because to Or confidence the coming is discounting I ease? you that [

Larry Wood

a Yes. We good QX had in Europe.

were to with more old product for do it. brand-new more at with think our probably PR a to we're that point discounting. a a with and like the no new And super U.S. And Japan, we're does beat we on. sell some put have so feel experience temporary, [ Europe have at it's proposition excited. that value it's Europe. They this ] in technology. focus premium feels going and people in bit it's And and to little pretty with this I something We aggressive

surgical on for in -- been again, So technology. has we're the market-leading platform we're something decade a the is valves RESILIA now. anywhere it's excited that because approaching that's our probably only dry this And

for still are So a product Europe. patients. for what's that make their be able us physicians on milestone to to technology based decision into think we get do best this And going huge it's long-term to their

Richard Newitter

days. just the on following up here selling And Okay.

or XQ then I think geographic the for go positive magnitude you there? Order way, you. days other you said, Scott, similar the to anything and add same to want billing in XQ, impact of

Scott Ullem

the Eastern similar. In or or X thing. It's a days, very Europe third a Europe and day day geographically, order day. else a same magnitude, everybody about quarter, of Sure. globally is

it's a the board So quarter. across in day third the really

Unknown Executive

Okay.

So more evenly split by region.

Scott Ullem

not and aggregate, are quarter, -- first Yes, X to the in Europe X the Japan quarter, third third is Suffice of the first say, whereas day it's more day at sure and had -- that it in we in regions level I'm most in the but days, in of total, the quarter, it's important. the in that day precision quarter. a

Operator

Danielle Our next with UBS. question Antalffy from comes

Danielle Antalffy

to Congrats on initiative. a initiative, the whole treated. good I start patients to the Larry, patient hoping acquisition appreciate get -- this year. Working I was

of -- your those of utilization we centers, get at at AI was you some implemented if about to QX any on talked color much piloting Day see wondering and could perspective? AI, at yet, this at could all give faster if a And on this if sense you're how the a some the centers. I what guys does that? from growth call, more You it the at seeing broadly what you if get quantify could can like growth Just Analyst

Larry Wood

place. referred in start patients not Danielle. question, of People And the appreciate the putting identifying come to little wiring systems they some patients. it's and the way hard I a way It's in. Yes. the to get still We're have quantify. just these remember,

leading the our that we've we it enough enough But the centers pilots by add we've even That's of an We've clearly think many the backed And undertreatment in minds, move aortic spoke gone. publications, the in patients patients. through run of pilot the phase now with And a these that XXX% really really, regulation how people. there's address academic centers in barely so investor that we been they conference, in It's validated really system, we upstream know when existed. those pleased -- this I we're identify the now. We that centers of have, done tap places we that the are those in stenosis. of to how where programs. with didn't kind into even I how not different capacity

Now get therapy. the to all matter patients these it's sidelines proper off of a the the going get steps of and through

time. be a over again, be And a X very this function. going be over, time. it's going our day, thing going extended growth drives effort something but continued that -- massive step the -- think, it's to I period is -- day be to this But to of this not to going there's It's

Danielle Antalffy

I Sure. And decision-making the asymptomatic more give we try. about little mean, asymptomatic. that mean easing I a this just processes. almost one quick but on I'd in at I workflow you about I plus guess Analyst bit and follow-up talked I assuming specifically Day, mean, asymptomatic both going the to get see you're thought know this to initiative, guidelines 'XX in XXXX? should trials TAVR guidance, but not acceleration the plus I

Larry Wood

think we going into be I the to speculate get see want And flight. it then to be guidance, really I cautious Yes. how are I'm talk that in to see the data, We'll plays data think I I'll TCT. happy out. that not what about are after trials not repercussions and to on and at

of to for say enough which upstream symptoms are holder patients get you our the there's the symptoms, stenosis. they I referral, aortic this with significant or refer is aren't tell the then can a on top And even do symptoms somebody large What for And it, though now care. has being aortic one. enough. cost are held that attributable a stenosis, decided is are diagnosed guidelines the have patient you any of patients of there's complicated number journey you symptoms right Patients a the number because severe is symptoms had to layer

powerful this should goes if you out be team more of gets older more mathematical of And end that it you turns all noise system. And a a should we If to with judgment. and makes of It equation, even skating the trial heart be referred have is lot difference it and a move should when into being simply the figure the with people your instead what going up below of sort and comorbidities, matter of successful confusing to field. then a and immediately So for is be asymptomatic track almost this have takes Olympic aortic to a that more I just X.X, that think care. of stenosis streamlining care challenging.

Danielle Antalffy

Love much. Thanks those so analogies.

Operator

question with our from Josh next Jennings And Cowen comes & Company. TD

Joshua Jennings

action and the XX to hoping SAPIEN about about prostatic ask lower to thinking clinicians it was be gradients a the XX X I the -- with and system. I And lower see could think, mean, just ability basis the sizing I different that provide, design TAVR mismatch or provide. that should and investors XX and SAPIEN SAPIEN that, for deployment optimistic and we SAPIEN diameters. just is the relative will a future Ultra really or rate TAVR benefit to

Larry Wood

the Josh. a question, great clearly, our And details. That's deep on Yes. and platform you're

tailor being able to our to really is sizing patient variable can we adjust this rather valve nominal, our of patient the it make the driving valve concept the to think I and different. than a

made to hemotite TRT in a with showed pretty we data ] that we SXUR RESILIA with saw the As tissue, it significant presented [ improvements gradient. the relates [ that ] we reduction

you if so copy Mark it of sure to you. And need get can I'm a presentation, that

platform to and platform So a UR enhancements we've made already a is RESILIA well. XX of as lot our those

would expect as there well. benefits we be So those to

Joshua Jennings

TAVR And the ] on Tavern [ Great. replacement then up to just just cycle. follow

But this that more on [ management and thoughts the... to based a TAVR And the, just would choice really kicks love in I TBD I second of for guess, TAVR patients. as is when prominent think fully aortic ] durability. on lifetime and stenosis hear procedure your I

Larry Wood

platform coronary platform procedure. really also [ platform and his -- its The it's to design in access our that with second ideal the ideal ] use the for frame procedure but that

] important. about needs [ I to a guess think it good be to critically going be needs to but think and on be I

goes those of [ you implantation, range is We we're to that sort trials our probably and older a way inflection we little now, getting and think kind again, I bigger time that in just time years bit well years. be patients. of the all X going of I procedure of point of where to TAVR very for the just are probably of ] is story. go starting by, couple PARTNER into that Tavern are back a suited it's that as think is for now -- old the part the platform if an And next good But

get bit that had, another but I idea out make or up they if number, powerful patient years a XX-year durability a The think durability having a without patients. have can or and you an you procedure. second of get XX years durability, have XX for be of a XX to of that And equivalent have procedure will it, open of

Joshua Jennings

prominent on [ kind And Connect maybe procedure your your I but there. just TAVR very -- on positioning thoughts strong, just Larry, surgical using side of, segment. first more RESILIA, if too, with piece, guess, just surgery I to finish the of the option becomes mean, the ] second is

Larry Wood

sure. For

plays platform well. that surgical our as think into I well

Operator

remarks. now gentlemen, Bernard and ladies I'll time hand And to for it you. for we've out Zovighian back Thank run of closing questions.

Bernard Zovighian

the want about ago. about today I you portfolio when we contributing think XX%. diversified Thanks, picture offering we Obviously, place all What to to strategy them company ] this comment it, is Thank the years the about and for everyone. TAVR, close with have of of some the company. big in we And is pleased you surgeon a strong performance very Mitral tricuspid with [ the of performance result put are so going much. quarter. the the

#X still of and [ the potential. us. now growth mitral a lot It's TAVR business for ], in a But company. sure, lot largest the meaningful a contributing of performance it manner, are for has our of very is focus. TAVR the tricuspid

year a why quarter are after of So with that term it year to deliver are are catalysts having. going the so all sustainable confident growth we is quarter, we longer we after

Again, for your interest. thanks

and or please to any have to reach you out questions, myself additional If great you. a Mark have and hesitate Scott not do Thank day.

Operator

today's Thank good disconnect. call. Have a may you. That concludes Participants day.

Edwards Lifesciences (EW) 25 Apr 242024 Q1 Earnings call transcript