EW - Earnings call 3 2023 | Edwards Lifesciences Corporation

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Operator

Greetings, and welcome to the Edwards Lifesciences Third Quarter 2023 Earnings Conference Call. [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 and Treasurer. Thank you.

You may begin.

Mark Wilterding

Diego, us. afternoon, much, all thank very joining for you and and good you Thank

coming you are Annual We to TCT the Francisco Conference. XXth at live from San

and is With Heart; today's Q&A and Surgical global Group portion are our joining our President our call the CFO, leader the Daveen Wood, CEO, us me Chopra, for Scott call of Structural Bernard Larry on of of Also Ullem. and Zovighian, TMTT. our TAVR

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

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

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

Reconciliations included that, over today's defined sales to are call release his results in during non-GAAP sales our constant which to the Unless issued between is I'd in currency also numbers and press on turn call commentary mentioned to quarterly for release. With refers GAAP Bernard the noted, comments. press like otherwise earlier today. growth the growth,

Bernard Zovighian

everyone. afternoon, Good

results the today's going results, some this and conference, to outlook the exciting are TCT Edwards Francisco. developed. trials, week late-breaking Included has Edwards start strategy, among call disease. Yesterday, these advance team reflects presented advancing therapies high-quality X our for of to X-year at which structural the physicians As patients are our a in evidence made development discuss Edwards. There from clinical are generating suffering data from innovative finally, all of commitment presented the to strong from progress of third patients preferred We lot stenosis. should the data Mark from TAVR being of significant PARTNER who about technologies confidence San data treating quarter with believe covering by platform the said, demonstrate has severe in our therapy review trial. our SAPIEN hosting for symptomatic have the for share we pivotal be highlights to III a aortic low-risk I these heart am continue

benefit and Journal's XX technology demonstrated unique offers trials, experiences the which a has rigorous year, death than publication, disabling THV indication. freedom patients valve over for management true more is THV million X from stroke X clinical This Medicine patient and XX% expands only X at X at XX% benefits. X of England years New is and with years and After now lifetime treated survival SAPIEN SAPIEN option patients. and

valve valve, of patients of are we millions analysis from the disease. of presentation our TCT, forward for to the therapy a transcatheter EVOQUE the kind X-month looking of at its tricuspid suffering Tomorrow tricuspid first

cohort trial pivotal CLASP the of result In with IID you a will X-year addition, PASCAL. full tomorrow, see

to of valve make vision to and continue meaningful transcatheter a offering disease. mitral therapies tricuspid our treat innovative progress of We to advance portfolio

several our last the patient-focused weeks, we X of important achieved to commitment milestones In in support innovation.

RESILIA approval Japan. surgical the approval third, system; second, MITRIS replacement transfemoral for Mark EVOQUE in the PASCAL for approval Mark valve; CE mitral First, CE PRECISION

trial ENCIRCLE any for in completion the therapy, of for SAPIEN the transfemoral MX. first ever trial the pivotal mitral enrollment the Finally, replacement

now QX performance. to Turning financial

Third results, double-digit of the quarter line portfolio pleased were innovative XX% global We with with in therapies. grew sales billion, quarter growth. were differentiated another will $X.X which of present our to by our led sales expectations and

year, the company sales the XX% full total be we to to continue to XX% growth in expect For range.

an the product performance provide will third I overview Now sales of quarter group. by

In strong continue $XXX platform year-over-year. see quarter up to XX% with million, sales leading our demand TAVR, third we for SAPIEN of

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

were and prices positions stable. globally, were OUS and U.S. competitive selling local Our stable

launch Ultra U.S., third were quarter RESILIA. the of our the successful sales X In by driven TAVR continued SAPIEN

technology. XX, clinical TAVR our are side, enrollment trial with pleased groundbreaking to pace we the in our SAPIEN the of On designed study next-generation pivotal ALLIANCE

In SAPIEN the forward the to the of Europe, at to Edwards presented PCR be London additional supporting data look in by conference growth program was Edwards broad-based our adoption November. Valves driven sales platform. We benchmark

Japan world, expected, the sales Around growth year-over-year, remain on grew more overall the diagnosis the recovery RESILIA, than many third as gradual remain who treatment Our we in the first quarter X procedure strong half a of undertreated. And grew where in reflecting was adoption market competitive and improving of faster this Ultra in we trialing of and pronounced in less patients focused versus year. growth. SAPIEN it

the the summary, TAVR the company's global a the future of of $XX by XXXX. further gives at our presented the opportunity company week, leadership, confidence combination of along In expectation TAVR this with TCT data billion in and

Now TMTT. turning to

Europe, forward as driven U.S. the mitral our milestones versus global growth. as quarter was year. across of by million of of patients the procedure platform, a performance sales XX% of PASCAL accelerating increased differentiated adoption the PRECISION This TEER the and activation past with centers well the TMTT took prior and several this needs more in significant step third Our of $XX unmet commitment achievement quarter. to important tricuspid

performance by our model. of pleased clinical outcomes, reflecting and value continue PASCAL high-touch impressive with the We excellent be comprehensive to brought PRECISION the our

PRECISION of Japan We in end year. are of the expansion globally, with expected PASCAL the continuing before the the launch

outcomes late-breaking sessions IID PASCAL at be clinical to to the TCT. part a TEER add CLASP X-year In body of an patients. the will as presented mitral look to trial effective therapy This registry our with we pivotal tomorrow randomized evidence supporting scientific as IID for and trials, forward CLASP of

in SAPIEN of are the to suffering pivotal offering ENCIRCLE one believe MX, more enrollment completion the With closer important serve from step TEER, mitral valve to beyond for disease. even trial option, an we patients we replacement value earlier-than-expected

month, this CE we earlier look on excellent for launch to tricuspid, Mark outcomes. Europe disciplined that a patient approval this In therapy received bringing ensuring new EVOQUE. to will focus We through forward

this this with Now, to option TEER. Europe in will physicians to have in access groundbreaking addition approval,

FDA technology This a landmark at helping and first unmet on commitment patients TRISCEND innovation with population novel to demonstrate II data our be pathway presentation presented the pivotal EVOQUE leadership of on large As late-breaking XXX breakthrough the therapy noted, designation. tomorrow and needs. our on focus the TCT, patients based replacement of EVOQUE's will on from science, trial and randomized

our and Surgical, XX%, summary, overall trial of by Edwards have the advance million mitral stronger driven combination In TMTT, for of balanced are a growth. premium technology third increased expansion therapies quarter achieved to sales introductions, therapy and lives and a of portfolio patients. In we to achievements global geographic procedure of to $XXX of clinical tricuspid we adoption of build proud the vision new transform

of been mitral data has excellent and clinical see supported strong the technology X-year globally, our trial. of this by recent durability our adopted from COMMENCE proven which momentum to X-year continue of because tissue widely aortic portfolio resilient We the data

future the the body enrollment our we about confident are including ongoing RESILIA of overall Momentis study. this evidence, of of technology expand as clinical patient We

our Finally, CE for mitral month. we earlier received this approval valves Mark MITRIS RESILIA

recovery Care Care, by Critical European third quarter IQ equipped We protection to quarter, $XXX shift expect launch families recovery with as we of in patients portfolio to technologies our of of remain We fourth algorithm. clinicians to sensors get to XXXX. In better in our the high our X%, decisions adoption followed focus to potential introduce continue faster. smart home these our pipeline full their with valves million designed strong index help confident increased in by the sales and make Acumen driven innovation Critical smart

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

Scott Ullem

Bernard. lot, a Thanks

We quarter to performance product pleased sales with groups. with expectations, strength third across in report all line are our

We represents sales We year-over-year XX% achieved $X.XX. growth. adjusted achieved earnings $X.XX which share per total of of billion,

per share adjusted regulations. GAAP full Our included $X.XX other is items benefited tax GAAP our A earnings U.S. per and release. and between from this of in today's a earnings for with change share reconciliation

quarter cover now of and results additional by some details third full our sales year I'll group. XXXX product outlook

driven SAPIEN TAVR reflected more SAPIEN X of family by launch double-digit was which valves. year-end. growth growth our driven staffing the In represent well TAVR demand of was balanced broad-based sales SAPIEN as TAVR a our the in continued by was majority Europe, global was continuation the as of of of country. Ultra the adoption RESILIA, remains track growth Edwards to U.S. RESILIA and SAPIEN Ultra improved launch Japan, ongoing platform hospital third sales U.S. growth X our the environment driven of A quarter the by sales before strong of on In valves. by

For QX differentiated in more U.S. by PRECISION to procedure sales, of full was XXXX the of to driven Europe XX% TMTT $X.XX and growth strong billion, continue global volumes. activation PASCAL and TAVR billion year $X.X we of XX% sales to expect centers growth. adoption our representing platform, across

continued order transforming our lives pleased TMTT patients tricuspid Overall, with clinical mitral achieve of in temporary towards therapies, disease. and portfolio our combined the are progress we vision a establishing of with with of to valve data

that In Surgical performance, implying range growth XXXX in XXXX double-digit TMTT million our continue Edwards positive Structural to billion, be will to in million $XXX quarter products. XX% in sales sales on We Based million. continue $XXX the to Critical to $XXX RESILIA year Heart, expect the we expect low $XXX continue million. of driven full $XXX year of the full in was expect to to full we adoption million of Care, sales by year growth $X.XX sales of XXXX. And year-to-date

upon be be and the For XXXX billion have XX% to we $X.X year total to billion, sales full $X.X year-to-date, year continue sales in to to of based the growth the range. range expect full Edwards, we delivered to performance XX% in

earnings our full $X.XX to billion $X.XX we between Lastly, $X.XX. continue to between billion. We're sales year and and share projecting to quarter be be per adjusted $X.XX expect fourth

projecting earnings per are quarter $X.XX. be and also share between adjusted to We fourth $X.XX

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

Edwards' the XX% was year, by period last was gross third For year. same Remember profit to in expected, an last exchange. quarter, foreign XX.X% profit from lifted gross year-over-year foreign impact margin the unusually adjusted exchange. margin impacts from compared as was driven by This our positive reduction

expenses profit to $XXX our be to growth XX% $XXX XX%. Selling, This expect adjusted full strategy our XXXX to of was continue margin administrative were or investments transcatheter compared year. field-based in We million personnel and XX.X% and general the of prior year gross performance-based support driven by sales, increase quarter in and in the between in million, compensation.

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

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

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

Turning to taxes.

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

the of benefited credits. regulations Our surrounding U.S. from suspension reported foreign tax tax certain rate

Our primarily tax non-GAAP mix stock-based excess benefit and a rate higher-than-expected compensation. slightly lower income from resulted from

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

an current to decreased rates, or by to sales negatively compared $XX XXXX. year reported to year. compared sales growth $XX by XXXX quarter we XXX basis impacted basis Foreign At third margin XXX the prior gross compared negative expect prior points profit third the million exchange our million to year-over-year rates now points FX impact full quarter year. approximately rates

as Relative share. quarter July $X.XX on million, to earnings negative operating million FX $XXX Free a million. cash capital less cash from for our spending of quarter was the $XXX activities of $XX defined had flow per impact flow guidance, rates third third

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

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

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

During under our the repurchased million third XXb-X quarter, plan. we X.X shares

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

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

to And back you, over Bernard. that, with

Bernard Zovighian

Scott. you, Thank

sustainable XX years after clinical this patients TAVR over III many PARTNER more patients Edwards' million untreated. positioned growth treated and and undiagnosed closing, rigorous is X-year than results, strong, week's for as of In X experience, remain

milestones Moreover, in Surgical, differentiated in In to TMTT many addition, technology. X about many growth global businesses, have we treat for and Care portfolios of mitral we durable need. us positioned the strong driven Critical tricuspid the by which patients achieving and our that are significant confidence long-term are vision progressing gives

a to through our drive Altogether, convinced tremendous breakthrough and future technologies the leadership. are patient of success we opportunity in focus,

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

Mark Wilterding

very you Bernard. Thank much,

questions, open our potential at host you we we California, up latest outlook about include I'd longer-term event market a our and information X. website. investor in XXXX it our are More Before Irvine, our technologies, will form on on available Thursday, like for XXXX. on December our remind for as which conference, on updates This to well as views headquarters registration will

ready we're Q&A Diego, the the portion of on accessing Instructions] ahead please [Operator take now. with that, additional to questions With call. go details

Operator

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

Robert Marcus

the this But It's this OUS. it tech. of a do foreseeable Pre-COVID U.S., guys to gives in presented start, holding supportive it was double-digit TAVR med XX% be market weekend confidence back you at you faster? much subsectors being you about similar higher slower Maybe here rates. been growing growth Great. the roughly what future? recover think for we of what's in should the to from can growth did How Data one growth. quarter, remain

Bernard Zovighian

I Let ask to me and will Larry here. continue then start,

is First, growth. of in row Again, are sales to pleased it we this quarter. third the quarter double-digit a

OUS. patients, untreated. in pleased at so very very U.S. U.S. to Ultra look as and Very between opportunity and And we in plan, about Japan. adoption going the are undiagnosed is We and well, many balanced with are it. RESILIA according

give of that are feel we ahead us. week even data of all good We we So the positioned, this well about us what's greater presented feel confidence.

anything? want to add you Larry, But

Larry Wood

really gets which, I larger. and COVID during our of in period seen the add. out the we've growth, been Yes. even it's stability as time, don't This growth third of lot the have see a that of to to we is business all actually coming double-digit straight rockiness continued that quarter good that saw our

our about So feel actually really I good growth rate.

to I sidelines to continuing we're think off the patients patient our activation. get work and

reassuring Medicine were high-quality data durability I signal with England that -- definitions. is here the worried for think And the patients. have we Journal TAVR. now data no using with at shows really signal durability VARC data of New hopefully, the about published X a years People absolutely

growth us all we are of double-digit long and think over of So continue a help those have positive period those and time. sustainable to

about great where feel I So we are.

Robert Marcus

product question Great. Maybe for one more me. here

It Mark. got EVOQUE we X We'll exciting This in excited approved a hear a really from months be about data terribly just with tricuspid see the replacement option. tomorrow for be CE You Europe not replacement. repair, lot. could in market is may a doctors but

this slow What uptake needs drive here that's do company an you market as in and repair? do Edwards tricuspid to pretty take and been adoption a to with think area accelerate

Bernard Zovighian

-- we the So going one, are focusing for basically we number what years, to the done on in do have on patient outcome. TAVR XX last

our team on going support physicians. is making sure other are is focusing well equipped to to it well why be So we trained,

and in going to maybe, going cohort evidence produce tomorrow. are here? to disciplined going Daveen, TRISCEND II to like we to you anything going the are And launch want to more are add have we see are Europe, produce We But evidence. a continue you to

Daveen Chopra

really of But time, evidence key -- No. for us step. do of more is appreciate to important. then, model for new is a and news long-term not continuing a that referral help having is this with. that Bernard as over much innovation, us, therapy diagnosis, a eventually includes about ability and apply Yes. really TAVR than from to helping us, the But I patients. believe it's ago it. to long outstanding build take and that. I outcomes a Thanks, work really on this area we're for said, patients play kind help to And No, think comprehensive comprehensive it's improve treatment to also technology, And high-touch but playbook really play us only the Bernard. we excited the that

Bernard Zovighian

we Physicians a better add here, I patients. at also still this add, more disease. the more to are option. And if treat replacement believe Robbie, understanding options We beginning that may even tricuspid have we will of of

but lot leading space, So for in past from few we a to us what are And going to years, therapy lot going here that patient we the sure learn having benefit therapy what Europe. in X I'm and will learn about are that. a patient

Operator

Our Fargo. next question from Larry comes Wells Biegelsen with

Larry Biegelsen

about I and the of Scott, guidance believe, year-to-date, is XX.X%. is the XX%, over a midpoint TAVR little growth the

implied we acceleration if low drives TAVR? And for had should thinking QX XX% be about So what for end of TAVR XX% year? the Then in the not, I follow-up. the of the to one range

Scott Ullem

you for to and and for quarter both because beginning of ultimately the the the I'd increased to We of XX% it was TAVR full results. Edwards the X% guidance to Well, our XX%. back year quarter second take XX% when to year first the

we So the and the we about we're our midpoint at our where QX XX% higher reflects than million stronger-than-expected for quarter, guidance full coming QX. and XX% In the in fourth company to $XX for The guidance in the QX. results about QX is QX. would thought

So the looks overall, you by quarter. the we unit, quarter third haven't can out that, broken pretty but similar we business that expect to fourth guidance expect

You're right.

said in quarter. probably the again, of because, for from first it's full year, XX%, mean to XX% the XX% reflects that the about doesn't to up we're going higher QX end XX% for increase that the think I but that to middle that we the range range

Larry Biegelsen

about people 'XX are right starting think obviously, to And now.

you So growth. that targeting annual Bernard, our Does apply double-digit XXXX? to revenue about conference, at talked

P&L the of any puts help thinking would 'XX currency. And we are and down FX of takes year-over-year are guidance appreciated. implies on because margins And be the be some should on Scott, that What in about? investments

Bernard Zovighian

Larry. Thank you,

part on it first take here. of question me your the Let

all December, will investor event. you get guidance, XXXX the for details of at So in our

company, question the is as we And confident. confidence my about confidence our and yes, a are

like opportunity during the so have many in As think an front I I amazing patients. said we us with script, of

All of leadership our are position, businesses in position. in global solid

to the confident So I am come. for years

come more XXXX, Larry. to For in December,

Scott Ullem

And Scott. Larry, it's

now your a second environment take question sales if at of also exchange it and But more to to part would specifics about conference. For the it apply talk We'll FX. be you right to the our rate investor headwind EPS. about of XXXX, the headwind a and

FX we'll to see more able be And as rates to specifically. we'll So well. happens then and quantify between what now that

Operator

question Evercore Kumar next with ISI. comes Vijay Our from

Vijay Kumar

first Bernard, that the data on noise you all in lot just X-year the for the when presented. maybe your for TAVR look one lines was on between at Does and you worry you at A Edwards' a TAVR crossing Control. and Edwards from that of lines the widening data. the peer, Street perspective

I how that that your think for defined you same definition use Is peer mentioned also in there durability also, are And Or durability. something trials? these X in differences the here was some definition? VARC

Bernard Zovighian

Thank Vijay. you,

level. in a we of detail start amazing comment here. for remember, into day, was keep the I to what very like survival believe and went it very I'm should years. X Michael. That's, Larry mind, my They the That's Let Dr. with greater night, it At went me design. very XX% -- the very deep ask at is high for last deep the simple. a at to but me, going patients. insightful of to event data They meaning data. the Leon with I into end Dr. trial investor the and

Larry Wood

thing this curves Bernard. continuing to just diverge accurate. whole really the Thanks, about isn't Yes, Yes.

is we from we the that you When we're we bit by sweep, impacted side and the death journal, double they're cancer. cardiovascular about patients of higher into think don't menus as Xx notice are somewhat withdrew we I mortality, manuscript, the sepsis, to the causes as were TAVR surgical TAVR is rates that years I TAVR at the And about which the had when the if the But I catch-up. adjudicated think and at little of a look group had not surgical as of We We go a causes on disproportionately. of the in COVID X%. you And cancer suggesting same. anybody COVID. absolute group. related. that think, or And X had, you showing death, be phone all in the did I had much rate think difference

What's both TAVR at get you into great looking the years. of X prominence So given performed mean, the is we're this surgical our the of we cohort, when incredibly that about data amazing Edwards' well. valves data, that then I survival both depths XX% the over have set about and at groups And groups data. feel obviously,

worried you're used. isn't And structural have thing And for with the freedom criteria. is durability, to TAVR definitions we been echo the derived explant about due was historically valve right, remember, surgery is historically other which people did that what use deterioration, durability. not VARC used, from Surgery

And contemporary so of New contemporary the publication part we is what drives England all standards, Journal the the used of Medicine all things.

So I don't comment people's on want data. other to

And You and used. them study. great again, standard methodologies what I'm about highest data feel we But about applied data. STAAR the can we very they the ask comfortable academic their

now years. significant less don't think them follow continue to happier results think X invasive little patients interim than could years, therapy. and And at are. to to people can default somehow a And people say, go are If automatically an of oddity surgery, that then we to that's to procedures, to the way X has we need and pretty than have your look surgery. years, follow any better bit I But patients. identical all be data and discussing here X we need these I TAVR be for to the to about at We XX data just at the we are the going we up a TAVR that there's

Bernard Zovighian

because about will safe PARTNER options, look and referring hope these undertreatment And that underdiagnosis patients, we they years, patients this been effective of options. about at of we saying think the have network you if X have Vijay, options, along you cardiologists send we hope more now in of all -- what III, addition, certainly a the

good feel all So of this. about we

Larry Wood

day, I'll think was general. great a for this great add, just Yes. a the field I in meeting

heart the want It's If I'm have behind told, TAVR -- heart I patients scared but I'm any data have to open just you on say, really early. who they're surgery, surgery, doesn't open have sidelines of still just too don't it. being

If signal X at X procedure can absolutely durability and years that at they years And there's no confidence presented, durable looking send you the look or depending community which that outcome. were both referral think get sets for study this patients a on just you're I should give tremendous that data at. they're going to

Vijay Kumar

That's have patients helpful. the implications know TAVR And silly There just headlines based Bernard, GLP-Xs? investigation you. for there Any to a some but Europe. It's and little were related it's or just look to exposure -- question, one is GLP-X any more on in in TAVR I here? financial to a odd, ask, headlines I

Bernard Zovighian

No, In Europe, had exposure. We that. there no a thanks. is financial on brief statement

So no expectation here.

With TAVR, regards exposure we don't to to so. think GLP-X

that. don't any We aortic disease. that. know losing any we seen that not stenosis We to impact evidence has weight don't have evidence. seen don't -- see We We any not have

So see implication any we don't here. possible

Larry, anything add? to

Larry Wood

No, agree. I totally

a think is it general to losing of and driven, even good I are never of things, people seen as is obviously, I determinant just weight lot derived be your those genetically coronary the things but thing, anything don't to to related think a these going things. we've relates weight and genetically disease,

So impact I this. see don't really any of

Operator

with Cowen. Jennings Josh TD Our comes question from next

Joshua Jennings

get just positive life and patient-reported reported and approvals hurdles? decision enough wanted ask views then and tricuspid first outcomes patient Are the driving outcomes on just replacement on to quality to -- clear your segment, decisions. potentially I X improvements those reimbursement of or repair reimbursement

Bernard Zovighian

I'm is start, can let sure then thoughts. good It a start. his add So Daveen and me

at TRILUMINATE was these safe patients believe to it quality miserable patients. have good who going of TRILUMINATE a We have about life it with We and correctly, far, EVOQUE, tomorrow. for seen to remember outcome for improvement talk are life. that. With need we a we good study, so great

the of of it at day, it tough are conference. life about of We investor talk So the at the about more it the might But end to improvements tomorrow, talk me at is day important. today. end quality our for

is for of anything? Solid that has you today. Daveen, options these start patients that, also profile see safety we add want who a And all great important. no as to other

Daveen Chopra

really European patients mean to that do ultimately to and it they is feel PASCAL these great of could I the trouble do want just we patients' see where day. taking breathing, them that It's approved, in I we their the really They lives. continue making our where tricuspid a want to difference experience outcomes do Yes. out think have that day we see have the things they to can't in helps lead. down. life live They technology really

of so that's us can need make these therapies excited life? reduction love. And community significant that's for down what with trial meaningful for this you patients. mean keep to data have decisions trade-off been high-quality just are something ultimately doing Wow, we It's to continue randomized regulators and to regurgitation patients. TRILUMINATE, to that the now looking in And see quality tricuspid I in treat see and be risk for the trial, tricuspid at the where with results presented by a fantastic randomized get TR to the benefit to we to they super and But make. are going safe that

Bernard Zovighian

What what It are it years, today where in about of was about we only said, -- addition about few like do we past in only the Daveen was repair. is, what we TEER.

to to vision. physicians our doing able a To now So are options. And have we being of offer with lot physician is toolbox. didn't what progressing a

decide patient, what they for So for what anatomy. can what therapy,

even still a months in that's ago. so a years And big few progress few to were we a where ago,

So great to here, I progress and see come. more

Joshua Jennings

for and strategy just sales U.S. TAVR and the on TMTT separate the franchise. follow-up one Just having X teams for

reps could from of hear to that's missing deep any cardiologists. garner are potentially just I some wanted the concern and Just And you their sales how with the synergies cross-selling you TAVR interventional guess that is relationships about going. these

Bernard Zovighian

So this. what about that to -- every who's I comment day leading ask Larry, on

Larry Wood

like, selling when were new our "Hey, expertise, all that synergy." But built and you a you remember, people really was selling level if that's a U.S., funny of It's organization of for sales organization, providing and half can we that were bad this back completely on are lot there's in TAVR a model we you of procedures surgeons, we a separate why and I transapical. and the you think developing whole it's decision. that to Yes. have launched get THV don't already about think that day look that sales high-touch out force a And

for that the we that decision therapy. the right was feel I think

experts. your Mitral salespeople, patients in be And our specialist be you are we've about is, all XX generalists to year. to clinical average the in X,XXX in I had experts your TAVR of different one specialists success supports and not and than clinical they're And the of field had try think aortic ask cases think if a reasons to therapies, them, patients. we've going I

think And We so case that it's and you every a really think drive patients, bring and expertise model the like been to of differentiated we that lot. driven leadership. And hugely I we what's outcomes which successful. level for driven therapy our what's

heart we expertise drive going all opportunities we General to now, success drive mean therapies, are our same And believe the talk the I structural a is what's the outcomes together. lot, We because of have to bring long sit that at level don't I best where because patients talked talk. they different that, look we Wayne, make our possible and the on to I for but us there doesn't for Manager these teams to sure highest want of the we in our franchises. time. Just focus so have possible organizations surgical work Daveen But time, we for and term, new of

Daveen Chopra

is This about. think on one from thing one really deep person I to as at consistently comprehensive in hear They physicians Daveen. love so they that's and is and so add I our talk Even tricuspid TCT, that. breathe, physicians, thing Edwards' is here all the high-touch I'll live mitral that they space, model. who the they're appreciate

week patient advice as the And possible And just to can possible so they physician, possible offer talk I love best collaboration the ensure best best the physicians. seeing that to result. the I to this

Operator

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

Travis Steed

clarify, I'm year full to Maybe guidance. add to I $XXX full your getting million, to year of QX When to different clarification. just is guide of $XXX $X.XX $X.XX, which a million one than your

was wanted you clarify So just mind. off. just I that, my restatement is or -- know there if wondering if don't I math to a don't maybe

Scott Ullem

it spot math midpoint the At Your what exactly on. the that's range, of is implies.

And $X.XX so range, it the midpoint, but ends $X.XX lower still -- take range. the to of within at up end the that

Travis Steed

bit on lighter on that being quarter, Okay. comparable. just going to looks everything And rates make Japan comment going growth on and to wanted and and understood in constant is Got It a Is then I sure the reported? Japan. this it. comments and currency OUS what's like some OUS little referring U.S. the of OUS

Scott Ullem

we All the growth rates underlying currency growth talked rates. were about constant

Travis Steed

it's think Or less you're think was last competition XXXX. talk if then And on still something hold coming you you lot fair. in XXXX? can new stable if market a But That's Okay. about question the with to not I my you growth to know fair than going in? rates share curious assume XXXX.

Scott Ullem

Yes. It's Scott.

product getting and question the our off And hold happen into get expect introductions new on and look of to of we all we conference lot a when kind forward to December. share all investor environment, There's we'll Let's stuff. in XXXX. details those forecast about together that that in at and

Operator

Wuensch Joanne with from comes question Citibank. Next

Joanne Wuensch

understand sort don't them, to to sounds like gross for on gross last XXXX, margins talk know you FX next to you want of FX you how job And you're it I going next year? but set impact about headwind of Two about great have the a Can us level with how think an did of year, margins. year. we

Scott Ullem

going pressure do to have we're dollars all the going Joanne. Really, share. we to topline. growth sales right per dollars on rates. is the until flow this you, impact underlying earnings reported December. our to sales won't we're headwind off to get to And to we going see But again, is to Reported to right think some hold down that, hate we say I can now

that's current foreign again, exchange Now rate. not

full we So tell the the point, all year you through details. really we the XXXX, you at go out more. when this we'll lay December But we get guidance to can't all and and for lines our P&L and through take of

Joanne Wuensch

valve double-digit is of completely which surgical demand? underlying and what's question, is it you another curious of did if follow-up quarter I'm My how drive maybe revenue. Okay. an from much that to have unrelated, RESILIA And upcharge helping versus

Bernard Zovighian

Yes.

here. start me let So

have So XX%, in RESILIA obviously, growth. of a innovator. you between off. What but also don't surgical we XXXX, remember, a like paying nobody our ago, we a adoption if know pricing we in see the here believed are very believed again, QX, pioneer balanced been in I pleased. been see premium few have is and platform, here years And in surgical we we we procedural combination innovation a our because and great

between premium but growth altogether, technology. our very procedural it balanced is and So

Larry Wood

the tell mad Yes. good that we'll that because little you life really conference that expense the the new you guy this I surgical guys you is, of at I'll when it just while, really get almost quarter to my investor those at -- a us bring feel think to business try TAVR. like after a at comes have is GM bit it. about It's frustrating I'll add. as both a units, gets mad and And runs we

but XXX% understand our aortic is So have to business isn't -- surgical what stenosis. you

treat treat regurgitation. aortic we aortic, mitral. even treats the treat just And business in we stenosis, space, surgical aortic aortic Our don't we

We have aneurysm we're treating KONECT, aortic products like where disease.

We have products. repair replacement products,

aortic a So stenosis. goes into more that lot there's than just that business

just X the to thinking about between think isn't game right that the businesses it. zero-sum the So way

Operator

from comes Matt Barclays. Our question with Miksic next

Matthew Miksic

Scott U.S. of you're the in -- the So centers one, Bernard, have how color different been able to if -- sometimes I and what performing. to types could offer on as some

to ways? staffing additive or in follow-up. growth to I mentioned stable. what Any centers large, You color were which have then And as size one small

Bernard Zovighian

going Larry Yes. comment that. Maybe ask to I'm on to

Larry Wood

sort every they're quarter, sort we make why we see bit. I up this will a centers that a larger spiked, trends then internally larger centers different and in think home, at growth And of segment, for look less. we'd we higher grow to little We bit to we COVID stay you and us, of and Yes. reasons it's just by rates the when COVID, see even little of and just people then will where return would smaller I to amongst the maybe we of kind tell tell saw you, COVID saw our grow said tended more growth. centers some closer during

I a think bigger to this across little kind the a it quarter, as in of we bit a little probably saw the of a I it's centers. bit little the returning smaller over -- than size. centers normalcy really, bit But sense relates growth more of growth center getting negligible think in higher to

Matthew Miksic

That's with on the guess, -- to into growth general a factors that? moderate And getting be your the little that's at over bigger, that this being But expanding not forward follow-up become just by helpful. on term. valve-in-valve important then about? growth the bit that just us the the or about long AS segment valve-in-valve I intermediate and how asymptomatic into big help market Or this indications point? more point. is factor only is talk market can and maybe does indication. How But looking a how that market patients in a valve understand maybe got the you one talk of a We now? the And

Larry Wood

Yes.

it's -- a think good question. I

our more It's biological online, patients option we valve-in-valve We road. isn't us. and TAVR they biological because valves. do down they of right in this saw the younger now. huge offering have TAVR I for think knew valve surgical more part a failed driver TAVR in as would came a usage so big TAVR-in-SAVR, not And

was platform procedure that, INSPIRIS, be that's it, very creating going -- for patients So basis think great the valves and these obviously, was basis we valve that would dividends that's road, surgical be a and to for are later. whole pay down live we will a whole our as TAVR that think durable, for the but a that longer, their

got TAVR, As we the patients the that's forever. need It's are second those younger patients still approval, will a that fairly low-risk for around new it's But something not procedure. that and just us. more back getting are come more been and eventually,

-- feeds become a do contributor it's ensuring in that you that first growth so our you true, think, a our into both that down first a us, valve. bigger And have when directly we patient come make they as of in option, your SAPIEN And about to option and platforms a they're advance we X great future which have really for valve, it as for what's is and management will great time. your strategy INSPIRIS it's an want having valve host TAVR our road, intervention. first back. sure for lifetime that just whether or strategy, the putting a next TAVR-in-TAVR as valve is whether we for TAVR-in-TAVR to the Surgical And a And that's over both that's

Operator

Danielle Antalffy UBS. question next Our from comes with

Danielle Antalffy

the difficult on data saw or that the that just saw And just in could is Or that confidence the data, readout? too give to of any that was size I data us yesterday could asymptomatic data make trial? can that the yesterday. we could Larry, up if I more wondering take and upcoming anything on something there's read the follow that actually we we X-year if from

Larry Wood

data read even this to haven't and everybody's Yes. an that's from even think anything haven't I early don't get don't that trying TAVR think -- I there's early on -- -- apart the I there's I data. And appreciate really TAVR. broken we early I

the don't yet even know I tell even set even if you. So anything did, about I to and about I couldn't data talk

people if more broadly away I earlier we the removed. I get trial think that people that's out is. do that data show we can is it will if But speaking, years think obviously just I the that barrier durability -- from on it saying, burden indication hope and with be want more X trial we that to that takes the successful, disease put board in which make that the is no at state. excellent whatsoever. do help is treat fact we will trial symptomatic And the one just the If durability durability one signal successful, successful

term long So important just I of it's and platform long-term durability the to on safety important, long-term the be going the to data and for build the continue PROGRESS be results to trial. continuing think and

platform treat that going the people and down you're with options sure road need to for it a these the you make has disease down have moderate you If durable to patients. road,

informs this TAVR anything about don't results. is it think early all I So but the trial complementary, I think

Danielle Antalffy

diagnosed Okay. Got these it. lot there. as you still far where for referred there's TAVR. mentioned couch And those mean, getting untreated physician's I as quick in then and Edwards' a mean, of off question any into guys weeks out what we -- we'll you Day December You are Bernard, But imagine on get office, seeing of traction I patients too a the of a their time just a patients on here. I last Analyst just like an curious say real about in can in you are some that? update campaigns, few lot process? things spent the that in at the December, direct-to-consumer progress

Bernard Zovighian

super question. Thanks for important We initiative to see as this the us.

have the right platform. We

lot a of years, year, We can in X how lot right initiatives, the some have patients. we of science, have done scale learned say, the pilots. maybe I we the so to We initiatives. get more we a want a to X ?And last, years, This lot. of

December. Larry have impact to talk his and to going we also. are interesting are like some we feel believe talk going see we more about about are we learning, team -- that and so And to we some But it. in starting it

the potential because when is even why we this of future reason. It is see, more is the about excited feel we that. believe exciting. we of So It

all and of want asymptomatic indication moderate obviously, will addition, to to anything? this. But you add In Larry, do add

Larry Wood

Sure.

or thing think we stuff mean, started educational patient back a years. for and the bit like last all find is questionnaires one are doing not little even in like that how with I to X year just I go way we a think the missing people information things I patient last lot a information activation and of website TAVR kits. patients, starting a center to it's

of and think, I and the market years, the several things a last doing lot over has grown So one the it of is reasons has. developed the we've been way

dividends a digital -- are efforts activation still our are right patient now. So think paying I and lot of

do. Now, prevalence the the it to the pool, have more harder and into the you deeper activation go gets you

same we're additional But into build maybe a a the we we're time mature a So more and you program it's a to It's pilots show get number us streams, bit we activated. And work that to you're that of trying have a forward to we at have people journey tell to going it's of to and sort -- that detail light investor very bit continue never-ending of I'll programs looking the to lot programs working on of conference little at a get on. a little about we last the lot. you, to try other lot switch. a not a with things have think and help do

Operator

And Chickering our question with from next Pito Deutsche comes Bank.

Pito Chickering

that you mentioned TAVR Per is your script, the share market stable.

market You seeing look and is FX? at Are doctors, competitive in against accounts SAPIEN where accounts CoreValve? competing RESILIA both or those hospitals changes use you any that with

Larry Wood

Yes.

very stable. And been I patients. confidence I big think people share going market increased does think it pretty has or think don't we've RESILIA. -- I into think give younger, excited I We're changes. lower-risk big about in shifts seen

I But But again, been pretty can think stable. to at bit a maybe about share good So we I little think conference. feel we that that. overall, generally more update the investor try has

Pito Chickering

Okay. then a Great. TAVR. And quick follow-up for

drive revenue the But benefit said growth? thought same you would to any think from the volume that I growth pricing procedure was growth. positive as there above was revenue RESILIA, I help from growth

Larry Wood

There of it big was benefit, our a driver growth. wasn't the little but

Operator

have questions management and for ladies today. we closing floor the for gentlemen, all hand that's I'll time back the remarks. And to

Bernard Zovighian

you. Thank

by meeting performance our pleased me with close in XXXX. am saying So this I let

I with have reach excited TAVR tricuspid and with the reinforcing our our the And leadership with new approved clinical mitral position expanding patient we am progress made, Beyond numbers, technologies. new evidence.

world. As patients confident more even are to long-term strategy in a our result, the we help around

your phone. you. continued Scott and The for I additional Thanks by welcome interest IR any questions Thank team, in Edwards.

Operator

disconnect. Thank And parties conference today's call. may day. All good with we a Have that, you. conclude

Edwards Lifesciences (EW) 25 Oct 232023 Q3 Earnings call transcript