Earnings call transcript Q2 2023

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Operator

Greetings, and welcome to the Edwards Lifesciences Second Quarter 2023 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.

I will now turn the conference over to our host, Mark Wilterding, Senior Vice President, Investor Relations and Treasurer. you. Thank

begin. may You

Mark Wilterding

Chief much, us. afternoon, call With Officer, Q&A with Chief very joining Ullem. all for us is thank for Executive the our along Zovighian, joining me of Bernard Officer, Diego. you Scott Care and Also the Good Daveen town portion you our our Financial Thank our on Leader of Global but Wood, Larry TAVR Global are with future our of President of us of and earnings Katie Chopra, Szyman, is Surgical she'll be call calls. Group Structural today, Leader Critical today's Heart; out and on TMTT.

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

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

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

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

are Management GAAP measures. is when results. using that financial constant-currency numbers referring in release. referring they during press and mentioned call non-GAAP to non-GAAP to between this are GAAP today's quick adjusted, and Reconciliations Otherwise, a reminder, available Finally, terms

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

Bernard Zovighian

and Thanks, everyone. Mark, hello,

Today, the even with talk our the innovation I'm and share with progress our to pleased team quarter strong patient-focused therapies. outlook in than advancing second across patients ahead. you our life-saving before the Edwards to years our about performance help the groups, in for work more our in am going confidence that I product did strategy, to

quarter, the across grew sales of growth, currency portfolio. on all therapies. basis, a Edwards Total adoption $X.XX innovative our by achieved of driven increased second sales of In experienced XX% our We than slightly double-digit growth broad-based we billion constant expectation. higher

in Given improving and healthcare first XXXX. to half staffing we results expect performance, our continue strong

given year and life-saving and As innovative guidance. a focused result, full We we failure wellness our in is remain largely and Longer-term, underdiagnosed our our differentiated benefit. lifted heart strategy EPS XXXX more even providing sales patients to can are and valve confident have we so increasing committed therapies undertreated.

continue our I In product we platform XX% million, for will year-over-year up provide on of SAPIEN the performance by TAVR, Now, see second demand sales constant group. with leading strong currency sales basis. an quarter overview to $XXX a of

Our OUS were U.S. rate sales comparable. and growth

X were in-line growth Ultra hospital estimate stable. were total sales by and the SAPIEN successful launch staffing growth. U.S., In with second continued levels, prices RESILIA. aided sales procedure selling TAVR quarter Local our improved was of our the We that

Additionally, trial, study technology, pivotal our to this of we restarting designed XX. next-generation quarter be will ALLIANCE, SAPIEN enrollment TAVR in

adoption sales platform. had all we Edwards' Outside of driven Europe, sales were In SAPIEN the growth of U.S., positive our currency growth broad-based from regions. constant by

first in constant grew year. to on and Japan basis, a and competitive continued half lower-than-expected currency our trialing year-over-year sequentially the sales results impacted this of market growth in by Our be although

OUS a higher QX result, TAVR overall we slightly As in Edwards' OUS TAVR was estimate procedure growth than growth.

can patients was on the XX% were experienced by very the with a SAPIEN reduction European treated efficient, implementing the note maintaining platform, medical length XX median valves the practices at outcomes. presented best on quarter, congress, showed It the that across patients centers compromising EuroPCR data X,XXX centers. study outcomes. more study with stay SAPIEN Benchmark encouraging During to that of hospital clinical in be XX-day This without while patient

three We sales TMTT. portfolio therapies, opportunity: and a value drivers to constant results to clinical versus a remain XX% prior million key TMTT Turning focused basis to this $XX increased second outcome. support real-world currency the on on favorable positive differentiated quarter unlock approvals and adoption, nearly year. trial of global clinical of

strong continued activation more differentiated our by Precision driven of was adoption centers PASCAL of platform, volumes, and the Europe. overall and Growth across procedure U.S.

on and hire, our deliver the high-touch grow team we continue to as We model, train, expand. field to

is is In IIF mitral -- patients. functional for trial mitral, pivotal enrollment Class going ongoing the in

We are the SAPIEN in and MX trial enrollment on the enrollment around also end year. for of pleased track replacement valve to this ENCIRCLE pivotal the mitral complete with remain the

well. In tricuspid, Class trial PASCAL pivotal the with continues IITR enrolling

for TRISCEND XXXX. continued enrollment, U.S. offer a therapy for approval of track remain completion EVOQUE U.S. With by end end the of centers tricuspid the the European We to patients. of II and access this for approval around continue XXXX on to allows

sales by both and our mitral million products surgical RESILIA across premium advanced XX% adoption currency on all regions. the and benefit valve of procedures. aortic quarter this increased tissue value technology constant Surgical, feature and of In of second the Physicians a $XXX for basis, patients driven

study RESILIA designed in the MOMENTIS of clinical for the the in to enrollment continued tissue durability mitral demonstrate the Patient our second quarter position.

from of continue of confidence products. clinical -- to the data of presented that RESILIA family our our our trial seven-year expect We will upcoming from adoption support recently

second driven our of monitoring platform adoption by from In Care, lines. led portfolio future XX% for momentum product $XXX HemoSphere of, positive our Critical quarter with also the healthy was Growth Recovery sensor. opportunities. pipeline and Sales currency in basis, IQ Acumen healthy contributions Smart million, increased our constant all a of was second sales quarter on by a

also mention our turn Conference I Scott, expectation I to upcoming over for TCT to Before it want October. in the

technologies. the X data pivotal low-risk transcatheter presentations our In conference, trial. the TAVR, are of clinical we presentation During a regarding we PARTNER from important expecting expect five-year several

anticipate TMTT, presentation a we pivotal of cohort of the one-year IID full CLASP the trial results. In

II the of Event cohort. TCT. you at host TRISCEND plan anticipate interim we forward of Additionally, we to Investor many look of randomized presentation the the at seeing analysis I planned to the

Our team will as get communicate Investor event. we details the to closer Relation

call Scott. And turn the now, over will to I

Scott Ullem

Hi, Great. a lot, Bernard. thanks

We products. with with the our Japan, sales grew are across pleased and currency the our year, which consecutive groups double-digit of posting in second was exception constant product sales of impacted half balanced double-digits competitive TAVR trialing of the were regions, the performance of quarter by growth. All first

operations quarter of support our $X.XX. which per by growth growth. in performance-based higher performance better-than-expected was adjusted share Contribution earnings in billion, in partially achieved compensation We the represents sales strategy. constant currency our sales our from achieved of $X.XX total investments XX% of We offset and transcatheter year-over-year

half earnings included and $XXX been the with next will Property has per other had Our today's which quarter. of Intellectual a last adjusted of paid long-term the was between for that expensed, We year agreement, on with earnings other GAAP for A expired GAAP impacted $X.XX by share half the and new XX share and items these commented be our reconciliation per consideration is million, last approximately and previously intellectual Medtronic I the agreement Agreement years. release. we amortized property in over

XXXX our some global hospital a continuation adoption product TAVR well of of on sales of the U.S. I'll represent was our by majority additional outlook of stable group. the to by of the TAVR Ultra family staffing RESILIA, more double-digit sales growth valves. full as second now cover reflected growth year remains details SAPIEN before A and as TAVR SAPIEN strong quarter of track driven sales year-end. U.S. environment, X results launch which

Europe, see was some but by continued of our are health Edwards' We that are treat patients. still their to was by driven In demand continue system growth capacity sales platform country. encouraged centers SAPIEN and to adapting broad-based the challenges,

expectations our In improve, rates SAPIEN Japan, although that ongoing X by anticipate RESILIA. growth we driven will growth in of QX, was launch the Ultra below

XX% outlook sales, volumes, global $X.X versus U.S. of on more Europe. low-end TMTT and now of the are platform, in to our and $X.XX quarter to Precision basis the XX% full by be the PASCAL driven growth higher XX% previous of constant differentiated billion strong a second across growth centers For year to We activation TAVR billion. we expect slightly to currency TAVR of adoption guidance to procedure XX%. adjusting was our

now $XXX portfolio of Overall, versus progress previous a toward million. we're data, to We of expect combined pleased year patients million tricuspid $XXX therapies, million expectation disease. sales to full our with the million and XXXX of mitral transforming in bringing $XXX vision contemporary clinical TMTT of our with our with continued $XXX to valve achieve of lives order

in strength as staffing driven continued In as of $XXX million. revised will now performance, in growth expect to in growth Surgical as in we be Based sales of year-to-date procedures Edwards' billion range $X.XX the $XXX sales premium surgery that by improve. XXXX. the Structural was range full levels Heart, adoption on products our low million million implies well constant of XX% previous quarter constant This currency $XXX versus positive valve have guidance to the double-digit hospital to year currency

Critical Finally, turning Care. to

million to million. sales to continue expect $XXX year of We full XXXX $XXX

strong in to Edwards, billion first now $X.X prior high-end total year sales of range billion be XXXX the forecast $X.X to the year, of full $X.X on the half $X.X based For billion. versus of guidance we the of billion to

growth to a the expect of be to now on year range currency XX%. We sales XX% XX% in versus constant total Company XX% basis previous guidance full to

earnings between $X.XX. expect full our we Lastly, now year be to $X.XX share and per adjusted

billion. quarter sales $X.XX We projecting third be are between billion $X.XX and to

quarter $X.XX. EPS We adjusted third are of to also projecting $X.XX

I'll P&L. of now our cover additional details

driven compared This For XX.X% from last our profit foreign a XX.X% was reduction expected, period same margin less in adjusted exchange. gross the to quarter, the second impact was year. as favorable by

XXXX between expect continue XX%. profit adjusted margin to year XX% to our We full and gross be

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

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

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

XX% to XXXX, we year be TMTT. we to support new technologies as of expect and generating to TAVR invest full in R&D continue developing XX% the to For sales, and evidence

reduction quarter, recorded regarding $XX million potential benefit our the second which This milestone reflects liabilities, $X.XX. earnings assumptions per per $X.XX. benefited was the our from by During an share payments fair we excluded value acquisition. previous of for This of adjusted a in share of consideration earnings adjustment contingent a

taxes. Turning to

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

tax tax Our R&D rate benefit basis stock-based XXX compensation. from benefited from point higher excess and credits a

to We special continue to rate, expect be our items, tax to year excluding full XX%. XX%

rates growth compared to expect decreased compared At we million year-over-year sales second full points continue XXXX basis approximately flat Foreign $X sales by XX or current exchange reported year to to to rates, impact quarter XXXX. XXXX. an

negatively minimal impact earnings on rates margin exchange to the April profit Foreign points second compared quarter rates basis our by second XXX year. quarter Relative share. impacted a guidance, to FX per our prior gross had

free Adjusted from Medtronic a spending defined Property $XX the earlier. million and Intellectual capital to related flow million, of $XXX operating Agreement as second quarter I for flow excluding million, of mentioned the million, cash $XX payment cash $XXX less was activities

be XXXX adjusted between year expect cash free We will $X.X billion full billion. and flow continue $X.X to

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

flexible continue of cash, We to June in as billion equivalents, $X.X and a with sheet balance cash maintain and solid short-term XXth. investments approximately

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

$XXX million remaining have current our repurchase share We approximately authorization. under

that, it back to over Bernard. with And hand you, I'll

Bernard Zovighian

Thank you, Scott.

have to our on XXXX by strong on are confidence making an bringing we our Edwards that deliver for patients. our based we to result, meaningful more well sales XX% extend XX% great to be for have differentiated will So, our important increased innovations progress confidence expect first year to and we while technologies globally. half leadership improve positioned many In closing, patients our Longer-term, for position further in to success. care I team growth

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

Mark Wilterding

a Bernard. lot, Thanks

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

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

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

Operator

Thank Instructions] from [Operator your first you. JPMorgan. with question. state Our comes Please Robbie question Marcus

Robbie Marcus

to recovery Maybe the weak the a nice taking congrats for process get and when system? XX%, in and staffing Japan. TAVR Thanks questions normal stabilizing in do Where think Great. you on timelines, a and terms the little procedures the we global system, are do TAVR in of treatment? start, a new think quarter. in around we'll Okay. And to stabilizing and growth you in diagnosis

Bernard Zovighian

Yes. the Robbie, for Thank question. here. you is Bernard this

are continued QX. U.S. have growth, We leading platform. in Also, strong result XX% that pleased our add by our constant is experienced with it some SAPIEN OUS, but Larry what global basically, here. I'm to in let comparable in hospital the TAVR U.S., driven has level for we been and going demand improvement the globally, staffing comments and currency

Larry Wood

better. what tricky, feel it's the little but - the has I to what system get Yes, normal bit Robbie. deciding like Hi, a new probably is continued

coming some leading we we're their not projected think diagnosis patients pandemic. we up track think are staffing, absence we visits, getting not - and when be I patients the look I the and we to and are moving where think of of in be through where system. the and they're we have I should would But certainly in when indicators, at we're are

tremendous feel constrained back adjustment call we still Cath made what Lab out that we're still level. somewhat not strides, That's to COVID We struggle. centers of pre-COVID think an And still and place levels. still a normal coming I but the I it's at have

we to still little think go. I a so, And have ways

haven't a the little globally. a we are Japan, we think there encouraging to COVID depending But and consider it a recovered I across a little think yet. still - in and varies see we think fully more at bit But here we're the Europe - dealing I I XX% globally little is, bit with see bit we that It there. thing and on lot and know

for under-treatment this still do us still opportunity the to and continue we to grow there's remains to better opportunities and long-term. continue the I huge So, think a of some there's know we think to lot over

Robbie Marcus

seems Great. that. beat Thanks of just the a more That over question. you it Maybe even the in And few years was like whole just talk past maybe than TMTT, TAVR kind for complex. quarter. bit about similar a imperative particularly general lot. a you thoughts normalization. tricuspid, how launch mitral competitive in the how versus to PASCAL play is TAVR just your and in adoption of plan, TMTT and U.S., think seeing you're the going in relative situation the Thanks out, the

Bernard Zovighian

Yes.

Robbie, comments here. start, will ask some me let add then So, Daveen I and to

something QX, the So, growing is are we pleased double-digit, are market as Precision Europe very centers QX, more like has well Europe. going in you globally. well. a see U.S., very of we going well PASCAL is that. and about What we seeing and back in to that U.S. It's very in The it's activating mitral almost the done is market, are across going and adoption well

from way great market the to activating momentum for centers. obviously, us more the some we PASCAL So, think had from Precision and it, about

here? anything add to want you Daveen, But

Daveen Chopra

Bernard. Thanks, Yes, definitely.

and it for Larry still there I continue during new got strong market patients recovery little that to but we're that from talked component. better and we the market, a is keep to of see side I continue you're seeing - the to out, recovery, see of a therapies, staffing think also of as large said, more on number staffing looking we on Bernard maybe But the a relatively still COVID. number right with such large being that opportunity portion a think I think bit we such getting growth. With hit coming about, in

centers said, being open we U.S. continue and in as the Europe. we it, new both into to That dive up

the U.S., U.S., accounts contracting so the ramping-up in value and We're feedback up of the each we're focused, opening in the differentiated of from you system. week-in new analysis do features week-out. the We're kind on can continuing team. committees great think in each center and here through largest the PASCAL hear to And far. the in benefits imagine, the with who we're the Specifically about new going centers week. really the most processes -- physicians I We're value-add as not U.S.

excited in U.S. we where pretty I'm so, And go about the

is actually tier. Maybe make market a just strong I in Bernard size, got but want I comment, that centers and therapy, space, for tailored-treatment continue again in the really to tricuspid both very to Europe, see and tricuspid been we're up the people growing growth, that seeing see opening differentiated to seeing strong continued very comment that, situation, a market PASCAL obviously for features is where to Europe, newer think, that in we've really these smaller are said, growth. really and especially this atraumatic tricuspid as new on Europe in It's

continue going So, excited be in it's we is to PASCAL about overall, where lunch.

Scott Ullem

$XXX then the you million financial at guidance of quarter. feel we're progress about, about for this and in feeling was to an original Thank the talked how We've of good sales saw million. TMTT and everything you. this last about that is We're bottom-end implications million is, by just indication bumped $XX And developing $XX million positive which Daveen Bernard $XXX our quarter And of the another our bumping range year. about up we it's how XXXX.

Operator

Thank Jefferies. comes our question. you. Taylor question with Please state next Matt from And your

Matthew Taylor

Hi my guys. for Thanks taking question.

about to ask margins wanted one the basically. just I So,

of the second some margins terms starting over of you ongoing takes course out? of phasing and then wind as down? key might especially to conceptually of I level, are margin clinical in you bigger the investments and landing about years, have nice kind the study to through two things a we in half couple should you're guess. your higher margins OpEx discrete a know gross call here gross next of puts think So, the had anything and or QX. how making terms just to lot of progression in at of year What operating of And I think about the so,

Scott Ullem

with Gross of seeing is Yes, more of than some that mix us benefit gross thanks for we're in XXXX. margin, flowing last actually hit start and offset the income questions. I'll but foreign by XXXX the it's in through in exchange, margin. year XXXX, our statement impact

current about You based QX, in going QX asked and get impactful rates. to upon more It's phasing. negatively exchange

the that But would, rates we gross and thought we may come margins first so up as XXXX, changed. range guidance little exchange to bit to where well. end half. expecting in little relative All in down gross if the bit QX change, Now, expect change a to for that we're right a said, margin really nothing we QX of

that of operating of we've patients expenses, kind sure clinician the making right about supporting as partners, putting got personnel getting and people terms earlier. really a especially In care, in been even talked that and okay. introducing It's these investment we're right, but in places weighing on growth the field part are U.S., you're making to right we've plan like Daveen especially outside, what and that's more the and in drive top-line by products that's expenses, new TMTT, sure our Europe, places, deliberate right of operating based into in

But do primary As growth. margin focus. focus years, we're expand for areas it we changes, make for a looking the our to secondary continue gradually operating that progression and can that. top-line our relates ways really where and it's operating of to couple long-term see operating we to expand is margin. incrementally over margin We've can identified The we next opportunities investing

over trials couple some of years, we've up. but ones wind-down spooling other next have the got clinical We

a us, contributing gone supporting the by trials Daveen of of two TMTT, important body drive this this running for in and sales those has robust super businesses. to that area is have growth really investment to clinical what we evidence TAVR, in about again is know in transcatheter and You Larry top-line

Matthew Taylor

Thank you, Scott.

Operator

And question. your Kumar Thank our next ISI. you. comes Vijay with from Evercore question Please state

Vijay Kumar

TAVR guys. taking my maybe Bernard, one question. Hi Thanks for on the here. my first guidance

was I at underlying the the high-end at think XX%. raised

back been perhaps that was quarter high-end to you XX% why has phasing coming the XX%. half first the saw, gives something something curious, the or possible? is within underlying in which XX% is some I'm half, raised? The you there even confidence there the Was TAVR

Bernard Zovighian

know, Scott. you ahead, Go

Scott Ullem

maybe of and sense see range, the the expected you Yes. Conference. give Vijay, the the largely top-end how in time results quarter it. and at in I'll we in we of compared back guidance, first the expansion the jump the second on performance Investor originally to here The half a reflects better-than-expected of what change

so, faster and half, expanded are but We're we first the way we of why the to XX% the over-achieved to modeling year. that that's And top-end. in the still growth earlier planning because midpoint higher of the top-end introducing scenario range we range, saw around the XX% potential we in reason this a the accommodate

Vijay Kumar

of sort one question related maybe here. And Understood.

us how think product seeing it's half, so price? a fundamental TAVR driving new TAVR, Why I seen - SAVR market grow hard SAVR macro-environment to TAVR the on mid-teens, the would outgrow that's and we volume just this Larry versus that we've color or First SAVR is much helpful. or I in staffing perhaps is still - see change some heard Is improving. of be -- SAVR was are versus introductions mention for outgrow TAVR. that's I

Bernard Zovighian

Yes.

I his So, add me and comment start to Larry Vijay, will let here. ask then

has market technologies, we combination innovative, of have premium and and TAVR that, So, growth, SAVR you a all nicely. a saw of because position. better of business Market because premium exceeded growing pricing both, of growth, our things. are of SAVR price not only, SAVR TAVR And competitive growth our but

of things Wherein to TAVR, happening. what SAVR, mainly number is in is growth. a you it again due have So, positive

anything to Larry you Maybe add want here.

Larry Wood

Yes.

sort I components contribute. of think We the have that three that's help right.

more of rates sooner. So overwhelmingly I those programs think a most the acuity saw as their bit is patient with recovery that into I prioritize say, a procedures, probably and it move we to on little treated, TAVR the get COVID patients things, but need deal bit combination hospitals turn though procedures look and little just we at a surgical through probably of probably will the all growth it and is you surgery. side for majority it's because can the

lab recovery. recovery beyond this cath growth. where lagged bit think we're again, has surgical saw maybe procedure a I we But the very happy little with TAVR So last quarter.

Operator

you. Thank

Wells question question. comes Fargo. state Larry with next from Biegelsen Please Our your

Larry Biegelsen

Yes, good call. this afternoon question, the the on thanks updates taking and on and TCT two for my pipeline

start I question II pipeline product, benefit, results news Bernard, but important big my TRILUMINATE a on TRISCEND so yet? is here. given stopped showed Let the look outcomes? hard guess One, it's to here. Second, is me trial is, like Arguably, a most quality-of-life with only just would comments, EVOQUE couple what success you, the your the no positive trends

I lastly did approval And follow-up. come on mid-'XX, TRISCEND if and could late-'XX, one II, think would positive, in not have I

Bernard Zovighian

full I Larry. of completed are you, Thank indeed II. see the are That's you yes, we the Look, that - TRISCEND enrollment aggressive. of we good. cohort

I wait need one then to all have that to need data, we think been FDA. together - in follow-up and of already we past. the that wait the putting to sharing We year the presenting

to believe the that is for in reasonable. faster, is we sure, still take XXXX I end why which we approval time, this think going XXXX of is reasonable. to around so going is U.S. some go Are So, but

technology, how I is using different seen different a tough results how was TRILUMINATE. feel little of comment Now, TRISCEND one using with because very what in we I'm don't is about do question know about - devices. your We we have to sure, about is II tricuspid light It disease. technology. steady TRILUMINATE do

say have important I to So, patients. tough that, on for quality-of-life it's super that very is comment but to

result this but we have study and the what we again, So, are of to will see we - confident. will

anything add you Daveen, want here? to

Daveen Chopra

a Also - that the points, two part for plan. question. was thanks small the of analysis this statistical interim If

of So, that's a these already been planned part always kind out to results. was and show

other delivers have PASCAL make us, that come device, Trikafta I'm results great - that actually actually tricuspid really TRILUMINATE. data. to Tier seen see randomized studies we meaningful that, for we've Technologies are the improvements have excited excited we reduction I'll previously with and what excited clinical confirm outcomes Tier And that with It that we're pretty by in quality-of-life these to from with comment So community. share a helps on with

excited So planned to tricuspid the to great what show. interim TRISCEND positive these in me, tailwinds we're are will all and analysis II see

Larry Biegelsen

helpful. That's

what the Just other you the one given my that here? say data, can the be focused TAVR Is and on there and think follow-up, been two in among converging data. five-year lay and some between has clinicians, Thank for you. SAVR anything X do investors one two-year physicians concerns? between the you could There PARTNER will concern on curves year

Larry Wood

Larry, I can't to be the the to what's going speak - or presented. data to

endpoint death, think to be was to people designed have stroke, we looking are what it are for, what what I And the rehospitalization three those do. a components. powered is, trial going was and at the composite of or and and

excited adjudicated, the But obviously to going and steering happening wheel all And going and the the it's data going for. and think, trends what is forward, first So, the that that's look think I and they'll will are in is are to people people looking once I they data. to the then be continue at sub-components coming and I we're the it at pulling foremost, the you present clinicians in see and take look in trial. the primary think the of that say do team what

do just every have we of I community. But, body time reports, our adds we to one overall these for of that's what I adds of knowledge evidence clinical think and data the the it think body and to

are. So, primary the where we primarily we'll again, trial focus we in the that's we - endpoint, just like see I did and on think

Operator

Thank you.

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

Travis Steed

taking a better. U.S. wanted Hi, little the I thanks to just bit on TAVR for follow-up to understand question. growth. wanted I

to don't versus in quarter. actually was price it that expected, the so and I but how stable, XX% said like you was it RESILIA RESILIA gone think U.S., sounds price U.S., in the sounds that out past of growth of I kind any TAVR parse much like has there's way

Larry Wood

the And your early look Yes, wouldn't reached the than the haven't for launch When UR. on for if U.S. I - at a for procedure it's yet. you lot did surgical thanks we're by you I what of pretty cost, in Yes, the necessarily it total small driven X,XXX, part, We're look even price growth growth. the in price but what that of a factor halfway we overwhelmingly SX call did go a the is - RESILIA we things. It's device for still increase it the at question. going list of smaller in RESILIA, call the percent we a side of the while as number.

us, remember, the contributor growth. discounted it's they tiers And So and to for volumes accordingly. too, but a continue contributor procedure they long-term certainly comparison and rebate pretty hit up, get as to go in a it's people's it's small

you got to in factor as all So well. that

Travis Steed

helpful. guide there That's the it anything historically? when what's Just for being did curious QX like follow-up you're seeing I the QX, down TAVR should this Is a Great. sequentially July? full giving think you raise the you on has like about then to full confidence the And year. think we about have been And versus in year dollars in raised guide?

Scott Ullem

the second we that half things. couple of reflective still midpoint range modeled Yes. that for overachieving the our and performance although modeling prospect the had the Scott. potentially first half, The provided. we increase A guide largely was of what in we're It's stronger-than-expected of of

it as the As the see leave far for so expectation, third July incorporates in I far what we total to-date. guess that range we out quarter just sales month we'll as company put the

into going month-to-month not report. we're get But the to

just year vacation U.S. trend the get in like, We summer the season in lot depends in may the not look of upon Europe but also later seasonality. the what of by hit a terms it In and

and third to QX. that the both looking run And be rate what third so get talk the into call, able about we'll impact going like back we on quarter looks more our quarter to for when

Operator

state from And Please Cowen. Jennings question your Josh comes your next with question.

Josh Jennings

One, talk Just two just TAVR on any recovery. questions. into difficulty] Can first, the Japan or [technical just insights you about share

Operator

me, out. handset? Could cutting up you Excuse Josh, your you're pick

Josh Jennings

now? you Can Sure. hear me

Operator

much you. Yes, Thank better.

Josh Jennings

Sorry about that.

questions. Just X TAVR

recovery enrollment factors and back on up the of on Any better that the the any in then Japan first are enrolled trajectory. year. the one, shaping XXXX. trial. half I on Japan end question the the market help just the PROGRESS patient pace, believe, recovery you of that just was us And to see understand Maybe First in how close limiting second on in the updates -

questions. complete about of and years trial XXXX or enrollment could So the been Thanks in taking for in enrollment that X.X XXXX? we've

Bernard Zovighian

Josh. Thank you,

in positive, as and a have COVID said, of seen but also is still So sequential couple still the expectation, the is quarter. like market, impacted from was what from and year-over-year a market our for One, you of is in know, I transient growth It recovering we the is believe COVID. it Japan, reasons. we below

transient, because is with early also, in believe of Ultra are very And X we of the the RESILIA it pleased launch feedback SAPIEN we Japan.

going like So, but improve Japan. Larry, we add our year-over-year below in feel confident grew we this expectation, want to are that to here? anything we we are sequentially you Maybe,

Larry Wood

that's think I right. Yes,

impacted probably. think during I certainly Japan got last year other think, more even some COVID the I regions than waves, in

had probably and to did that's And that think all continue back into stabilizes, think sequential. year that, going in We that comments. just growth said, we're factored our as see and we our so that But Japan, the of we reflected And half recovery in And that's to as the year-over-year guidance. in I higher we're what's optimistic expectations. see helps. Bernard

a more probably about probably any updates on has don't little been But with that can we will bit more enrollment more be we'll I a we'll have how some have that belt PROGRESS, investor when that conferences we fulsome say, accurate our right information a now. we've a lot on more our little fulsome provide update then probably pleased and projections. gone. overall, projections, trial probably under On probably more

Operator

Thank you.

comes Pasquale Chris Please your next Nephron. Our question. with from state question

Chris Pasquale

a modeling. there than was half Street It first a bit by about is Thanks. margin in versus XQ. like is contract in were particular back lower dip? looks third to expected that then couple margin where little Scott, the anything operating the bounce you drives guidance basis and XQ quarter EPS the in hundred the of Is points that

Scott Ullem

go pick we top summer really through not as hits seasonal. us Well, up which And generally, the it and is to reflects. are only seasonality, about thing continue the on line. the the expenses particularly That's what QX

Chris Pasquale

like just double-digit hot half that here looking first assumes there? been particular And guidance know tougher Critical Is you're just at the call half. there has comps but something a looking is guidance, that business meaningful Okay. today, is pretty looks of or the running It growth back Care Cath in year. the the on I at not decel in

Bernard Zovighian

exactly. No,

it. last a Thanks we of comparison a guidance is though the it question. but the the after great change got the tough all across QX for guidance product about in very quarter, changed We had You more in balanced a great QX, second part the the year-over-year And didn't lines. even year. we

Operator

question Please state comes Miksic And Thank question. from Matt your our you. with next Barclays.

Matt Miksic

much the thanks Hi, question. for so taking

as to this community about of in proficient performances Europe are I the that not given pertains wanted talk very with and grew folks And you them to TAVR folks. about strong SAVR performance kind staffing. interventional and TAVR trials bit I it clinical little the a up talked resources volumes. So many little of who and are TAVR follow-up more U.S., But of during in a maybe replacing other can price know good, and strong in but as TAVR sort on clinical those news, that - across lost good you of

the curve. maybe news, still coming of are bad those But folks some up

one productive, the sort of centers I of the heard are TAVR an on - color that which to you And skilled, is some about surgical mature, of If that are issue is side? the follow-up? issue get be some talk then less versus quick X interventions - on more one of could more bit great because factors. other, it of a mature have and But - kind SAVR side more are that from more an would more you've on that's

Larry Wood

Sure. Okay.

shot Let me take at a that.

TAVR about and of biggest that saw clinic a goes coordinators before through job. really in the number is moving system. were into lot that I we when And probably on things that So turnover demanding talked valve I train. we think of place a people side the we There's think part just clinic about the And the screening coordinators. terms of

think there's a so, And I lot.

more turnover So little we certainly. a that than than see bit

on in level patients the because patients, not have CT. up. the remember, And fact, have They to TAVR really on have the a to a And CT. have side a work side, more we get don't gets don't surgical work lot surgical - every most same the patient get of

so, week. easier deemed a days just a And move patient a or in few right literally, process matter they're for they comes to if to of within a it's move candidate surgical the patients a through can surgery surgery, and because

to Where for you have have they're that other going be out and there's a for CT, to disease to things you coronary roll TAVR, scheduled got just do. to

the staffing impacted system So, have are whole just across on there would systems the system, in side. more to but there's that in the TAVR pressure impact

If still operators. lot lost. the didn't our lose We lot people have a didn't up coming lose people of the those We we operators. aren't - of residents and not system. our through We a

general much So it it's implanting as not the positions much as support so is just staff.

Matt Miksic

or stage the and PASCAL and helpful. Got team, like see group mousetraps advanced these still a and forward? coming flush Bernard markets TMTT and programs innovations question for on and and maybe some valvular time I'm programs that we made where Thanks. or And it's at just investments it. of you out ago. the expect out other the EVOQUE the we And now what of more wondering those sort there of hunting kind further IP the some That's of sort - you of made should through Or rest clinical got that about that need address you've going a disorders? are better investments then to - to you've technology investments you additional just you are

Bernard Zovighian

good This is Thanks, Matt. a question. very

TMTT. vision about our in think So

and large we to we in building are And Our that need need, market able this comprehensive is vision there to unlock very portfolio. this believe patients And opportunity, are tricuspid. comprehensive portfolio. we be a mitral so many

So what in us investing next-gen innovation, can you expect is innovation.

X, So Gen mitral the same same replacement. PASCAL X, Gen with X, with Gen the EVOQUE,

side. is So on this technology the

our with close space, In you study in between did experience - clinical probably is the Then it we even we don't and know need X, - randomized TAVR, X we I from to evidence. many our potentially know or XX in a more how competition. TAVR, us X, technology

to about So same think way. the here, we have will

So like in our we more my all like not innovating to and further come. to are TMTT we far, in treat all evidence, we in able our mitral patients, are providing clinical and so at are not and are patients. tricuspid of be term the we clinical done mind, - definitely evidence done to We technology, we of that

Operator

UBS. Please And you. your question our Antalffy Danielle from with question. Thank next comes state

Danielle Antalffy

the the Thanks things one we there. you one, not everyone. out through question. as for backlog. I in likely of taking afternoon, high everyone's know TAVR and did Good two backlog, move of on of is QX, the nature marginally Larry, procedure questions QX. it maybe, I acuity know just Hi. impacted or much much are trying benefit Number the sort so figure Bernard to TAVR,

if curious work of QX? saw down any Just first you in think question. the That's you that

you growth. quarters, gave few last the color centers the low-volume over driving lot a just is question Second of volume some on high versus

is Thanks there, centers. if color broad-based whether high-volume some really curious and give much. Just so across this could low you

Larry Wood

think with I Danielle. again end a the that fill up growth funnel on see back probably Yes, there we we mile as starts talk seeing are possibility we that we front Thanks, part little Yes. last about that referrals a of actually pressure think the to and of a the being as bit the staffing. the still is most backlog

the our able couple wouldn't probably it's we've of seen double with patient a like that pretty growth centers But the be I digits been bushes quarters of and of more beating this quantify we're are and year, directional flow right patients, for not TAVR into our pleased for that the it's just out first to we've fact thing. in back of and sort the now.

positive. obviously that's So I really that, think

centers, the that we I - would excellence think would of large that to when a large come faster terms centers throughout saw centers more. go small then - centers, travel we COVID of COVID sort to through the they're away, indicating bit more little way growing tend to people back of centers, with it to little in smaller maybe tend the see go and the people a willing dynamic stayed bit When people to tends local. COVID a

than in we past last centers lot large large think the more quarter-by-quarter. saw the the this this quarter we small the growth in that little a But centers, have I saw varied small been So quarter than something has a more in ones. that's would bit in but centers

Operator

state question. your And our Richard comes from Truist Please Securities. with question you. next Thank Newitter

Richard Newitter

taking questions. here. for Thanks the Two

range trying the you the first reconciling in second need high midpoint the improve end TAVR raise a Or the of to one, embedded relative pieces. dynamic your of Japan your kind and get to The to what's I'm the that just to the guidance? Do of way to end? is commentary on just expectations. hit half upper reconcile to in two to those Japan

Scott Ullem

that's Yes. in midpoint We're QX a assumption about and Japan expecting contributor to better the our and QX, to range. of perform the

then range. a the Now range. And Japan the end get if us that could it of higher end does better expecting, than of does we're the worse, into lower

for it's that All and longer important Japan but term. is important our overall an one, growth TAVR, small us of said, pretty still in driver sales an it's percentage a of

Richard Newitter

- that. just then And thanks for secondly Okay.

Secondly, just especially the got - if about about RESILIA you've you're as XX% at in now, some contributing TAVR, amount. think pricing U.S. we

'XX of your single-digit it's as levels. So market the the normalized whether that out, or we way to RESILIA, I as TAVR back be growth right guess think if to it? has approached thinking about we sustainably you're XX% Is volume high basis, view should on with a we that just think just think normalized

Larry Wood

constrained still the of system growth like first to feel quarters. untreated try continue as here. of slowing in somewhat runway the for have well. And we still in we're answer on lot space. we still I a can we within certainly I a think put pretty double-digit the the as long We we're the to and Bernard to don't in try We actually said that. or and patients through in overall there's staffing think an seeing TAVR and we earlier, jump two that, system, I'll No, get think growth Scott board

begun that haven't we go impact I a like like long-term much opportunity, of early the like progress trial So obviously out feel and there's things long-term and even to further. TAVR things still talk about

try - to to way think growth That's not just we of this going that anytime soon. I population go is it. So the see think how

Scott Ullem

in just Larry, confidence just reinforce bit that, $XX addressable add billion that, changed in our hasn't total one to to XXXX. market a I'd

a And indications big U.S., product lot current so COVID just and our TAM, indications still interrupted that portfolio we while of trajectory our new current with in we've in feel got larger confidence technologies the of to to our not Europe and broader in ahead beyond. that us, but that, growth added

Operator

Thank you.

Our next question Deutsche question. comes your Bank. from Pito state Chickering Please with

Pito Chickering

afternoon. Good Hi.

questions here. So two quick

U.S. the that the ones coming geographically? spread that COVID? are out markets versus are centers For the it out were in geographical COVID growing of Or broad-based of for there markets, there faster was is any were coming these south - large in that still

Larry Wood

in country different of where policy any they lot saw middle various how was were variation at a given because and reacted. of based terms COVID point we the lot When for in was in health there states COVID, on Yes. variation care of the of we in a

saw a variations. of we So lot different

have anywhere those used or sort region that of state we of we're most now. that dissipated I and don't say seeing in from true restrictions And to U.S. not state region to would to - I see, certainly near variability that's the high

exchange say region. little where not bit we near regional of another in bit where I we anywhere during seen if But back history, little always -- regional we've faster country much a would the one variation more, COVID, little more from we see do country. I saw we Europe, that saw to In impact now. through it's Europe than enrolling look huge They're And a muted swings now. a

say. So I not normal, to maybe pretty it's normal, getting it feels but it's I'd like close guess,

Pito Chickering

market, market share enough. what need the restart And about network. lower Can market? the mitral Fair U.S. the talk mitral think market you Okay. looking your to they growth any overall changes that your growth of the then and competitor is in referral about how you in and to talking grew like with long-term market

Bernard Zovighian

QX What in add? even comments. market in sure, here me Daveen, But can here start the we precise some a QX the more have let U.S. is recovery in commentary nice in to So Europe. you I'm and and add seen you and in mitral have Daveen,

Daveen Chopra

sure. Yes, No, definitely.

growth. I the say the we're of and I'll to we overall think very specifically TMTT continues up I that right, in just well though, to basis, do mark, mitral, U.S., with maybe strong market on globally. mitral follow XX% tricuspid close both that to grow kind In and in -- global see a

which kind I is for saying ballpark something were in see U.S. the like growth, mitral. think, almost of like Bernard, double-digit about we

not it it's global as think but strong we as So is the nature. there, on

launching in remember, in of As that in the we just this time technology few very are countries you countries coming first Europe We're are for even countries. in into these Europe, many, there. countries technologies launched still many - countries outside world, We're yet. there many the haven't of into

as new the we countries, So of as the in we market adoption continue as well in to grow U.S. help that mitral see, launch the will continued

Operator

you. Thank

question. comes next your from Please Maeder Our question Adam Piper with Sandler. state

Adam Maeder

afternoon, both squeezing ask here. Good Hi. them questions, Thank I'll upfront. guys. TAVR-related in Two you for

Ultra with is remind that, talk study, then us And the clinic? enrollment launching like about effects get here SX in RESILIA. you're the in you clarification First study. where the this ALLIANCE obviously, on just I we question And on of to that second Can restart that's a going the are back improvements quarter. just XX terms know or States. it enrollment SAPIEN sounds to the in

launching. I Europe? in status in in technology the - the think taking that questions. of approved Thanks that's What that is Japan for

Larry Wood

in were system of we they Sure. Well, XX, the terms delivery all changes Thanks. made to related.

or the made make the changes anything quickly to clinic. those along get pretty why lines, back there and any in valve changes the weren't is So which able we were to

we're where so pleased are. really we And

approved we're to And all begin enrollment.

Now centers IRBs go already and But to have centers have are back a back that of go go. we in to to whatnot. all ready the and the greenlight number and

expect again we very enrollment So to very, begin shortly.

once PROGRESS. a not to little we the bit conference And going at really where we about do that probably it's it's on we're finish. are, have update like enrollment, more We'll run investor we I'm think not where a of an to much because give ready probably projecting

And more bit on a answer so give that a little later. fulsome I'd you rather

huge regulations UR, devices regulators on we're there's to been are with there's just huge in the also the Europe a working And system bottleneck of in of a SX way that. through terms their there. the working change MDR the remember, European number process. that in But

bodies on all we So new sponsors. Frankly, timing and have that. notified are are sort the learning any about all regulations don't of the how the play as

But yet. We we in and on expect of Japan, So be exit both do is timing in that's have we those U.S., approved we have underway. as do we that the underway. the it have platform that approved well majority any and in to And the don't it launch that markets, year.

Operator

session. you. remarks. have call the to ladies Thank over and the the I now will now we turn Zovighian reached And closing gentlemen, Bernard of end for question-and-answer

Bernard Zovighian

Diego. Thanks,

so about our XXXX far performance excited am I confident saying by year. meeting the in for the this and outlook in close me rest let So our of

with addition, to beyond on trial I help pleased progress strategy the patients. and pipeline am our In long-term clinical numbers, our even more in development, confidence

Scott by questions interest welcome continued for any Edwards, and I you your Mark, additional in Thank phone. Oliver,

Operator

parties Thank you. And may Have conference. today's a that evening. All concludes disconnect. good

Edwards Lifesciences (EW) 26 Jul 232023 Q2 Earnings call transcript