EW - Earnings call 4 2023 | Edwards Lifesciences Corporation

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Operator

Greetings, and welcome to the Edwards Lifesciences Fourth 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, Investor Relations and Treasurer. Thank you.

Mark Wilterding

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

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

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

annual of involve earlier filings, release. With like Information on differences Bernard the included safety SEC commentary company's for call to mentioned Bernard? website actual and which sales in quarterly could our uncertainties available and during to GAAP the differ over report Form be found cause other also the release results growth to currency may issued information today's non-GAAP at growth, XX-K Reconciliations are between Edwards' otherwise call to defined all release, on refers I'd comments. press sales materially. today. Additionally, his numbers that XXXX and noted, that, turn in constant press on are press is edwards.com. Unless statements concerning the our could risks that product and factors cause these which important the the in

Bernard Zovighian

everyone. innovation as At new conference, will I our XXXX key confidence welcome, performance as heart our of patient and Mark, exciting address theme on build our needs. share in I investor and to unmet introduced you, in strong Thank team's structural a well highlights of vision our significant of XXXX. that recent era Today,

and mid near, financial pleased including results exited with ensure of to the year growth innovative billion with the our sustainable are full XXXX, and and are driven of by XX% X better We we each and to growth key healthy leadership. we strong product $X than strengthening technologies $X These of XXXX long new groups. enter positioned are well new more up invested a momentum of performance including expansion we the term. portfolio to year XX% growth We heart QX era were sales in strategic therapies. In expected, our indication TAVR introduction We TAVR, our structural across strong growth broad than strong In milestones, with in of with and research achieved development, XX%. our innovation. billion, of

in of without in of these of aortic plan trial a early this we that healthy, the data years adoption treatment to very important aortic year, a large with for randomized We as symptoms. as patients flagship Ultra our trial to At achieved strong enrollment moderate technology, initiatives pivotal pivotal treatment SAPIEN experiencing a with of we believe enable also of from approval the all-cause sustainable X stenosis, treatment mortality, TAVR X, us schedule. This It EVOQUE favorable XXX pleased range twice introduction a reimbursement is Europe. estimated enrolled re-intervention global TCT USFDA only TAVR ALLIANCE trial to the adoption. clinical be I patients, stenosis. EVOQUE first milestones all shows significant present has of patients, U.S. We that of their trends hospitalization. for January, for to severe our am expansion the heart a TAVR, growth treatment of for aortic ahead step severe important XX. In X the and In studying groundbreaking potential next-gen recently an significantly approximately continued but announce in are completion position also milestone SAPIEN later continuing the TR studying population PASCAL pivotal exciting enrollment achieved improve our a RESILIA well trial progress, stenosis patients. option transcatheter development patients. This very a not receive therapy future. In and NUB we wide recently became therapy of status life, to quality granted with but in in and TMTT, Germany, failure the into the EVOQUE was will that to access

mitral EVOQUE, are of portfolio replacement introduction for ongoing and now offering of and we patients. the tricuspid and With solution a transcatheter repair unique broad

an pivotal in disease. as the the point us technologies catheter-based to from of company on portfolio. millions MX portfolio enhance commercially to only that enrollment approved confident In are patients a addition, studying and suffering of the we trial completion reaching inflection am track mitral SAPIEN treat our further tricuspid put of the I with

surgical to with TMTT, issue, business. the progress company our pleased and we was RESILIA are pioneered which by the addition meaningful In innovative TAVR of

We million supported Critical The evidence. enable of RESILIA-based and as X.X progressing XXXX, announced will previously track to planned X of the by valve with hard clinical Care on heart. is focus patients by spinoff our are sharpened of treat years on end structural

will distinguished. organic XXXX As more a even be result, rate Edwards' growth sales

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provide some product year XX.X% detail of Now In increased group. our full sales XXXX will by billion TAVR, I additional global $X.X year-over-year.

long-standing valve builds by This tissue advancements remain Japan. The platform. year-over-year. in safe, In globally on technology the similar. of in with effective rates pleased was valve and technology years tissue durability know-how leadership Performance Edwards' the U.S., R&D local X significant company. the driven on proud were in more heart with and and competitive growth combining global and and specialists continued valve. Developing Europe long-term commitment, of was on U.S., RESILIA be fourth company's expansion Ultra growth sales also SAPIEN expertise and by the and double-digit XX% the SAPIEN price and OUS Ultra quarter, the position million and TAVR were industry-leading sales a durable while the to increased our U.S. Our we stable. requires leveraging we X,XXX stable are than engineers of across XX X selling adoption innovation science In XXX

to are structural invest in We proud and will vigorously heart in uninterrupted continue these platforms. of leadership

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X faster strong expected, than After than growth. Looking of SAPIEN as recently growth. Mark patients our and in the for SAPIEN with we growth TAVR leadership and ahead, planning overall RESILIA, we launch. global were we over platform continued years XX for clinical sales procedural for approval around with million experience X our more are pleased and is and Japan, world, disciplined the CE with sustainable We positioned are treated Ultra a rigorous announced pleased grew

awareness, future global undertreatment are the for and new delivers in patient indication management the confident driven we TAVR, increased as activation, patients, platform adoption. lifetime RESILIA Given AS in of that expansion technologies such well as greater a rates, as advances by

opportunity drivers of the and $XXX patients, XXXX, clinical treat range from therapies, increased both best-in-class experiences, patients. million the focused increased have transcatheter to a global provide our therapies to for the sales TMTT the by more In outcomes. of Based EVOQUE fourth portfolio value U.S. a of real-world constructed edge-to-edge Turning year. PASCAL now. trial we overall clinical we key the sales which and to carefully were $XX will the repair unlock platform a the adoption unmet million accelerating adoption differentiated ongoing were of quarter and need. driven portfolio approvals of remained encouraged We significant activation sales of clinical we to SAPIEN support versus long-term TMTT learnings QX differentiated favorable on deep achieved results XX% year. by prior and MX repair patient XX% prior leading to Full and versus large real-world patients. PASCAL our provide PRECISION, solutions PRECISION of double-digit mitral procedure, our replacement the highlights year centers transcatheter on trial technologies and Europe. strategic intricacy have for across growth of and broader positive

we to initiated Japan, treated patients Physicians more the first with FDA patients. with the approval launch replacement, of We of have recently of the Europe, for And in a EVOQUE received have repair in completed continue case. globe SAPIEN where Pascal replacement, U.S. this mitral X proudly access to around new novel we In goal countries, with outstanding regurgitation than program. system. focus continued patients tricuspid continuing tricuspid global in therapy. In eliminating outcomes launch, PASCAL our including expand Since and access PRECISION we on in the we XX,XXX are

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reaching sales technologies. patients of surgical our and adoption global therapy approved versus procedural summary well with of remain sales full us year. Fourth In of premium overall live our We $XXX As portfolio strategy XX%. committed believe and million driven an a volumes. $XXX frightening quarter Growth technology for disease only of our point mitral prior year we global to leadership. tricuspid for this strong differentiated catheter-based increased to positions TMTT, by RESILIA are inflection million XX% bringing increased Edwards' the group, and was the global product with

about role its in of tissue improving confident We lifetime patient the future and management. are technology its

globally in We adoption with and those with including surgically, continue treated concomitant continued positive best momentum to our patients see complex innovation for procedures.

study. clinical feedback. approval We the overall valve received RESILIA evidence, MITRIS continue of CE fourth range favorable in our body have ongoing momentous Mark patient to the countries RESILIA with several to enrollment in quarter our We including physician and expand begun of European of

strategy Turning the informed their Critical equipped the lines, sensor sales a get Index home to million year clinicians expansion, was by sales I Fourth contribution of smart over XX% $XXX driven IQ call increased that, recovery with of are family more turn help decisions will care of drive smart XX%. make Full product from is versus all to growth recovery which to with Prediction smart Scott. Care. Care with and the designed increased Hypotension $XXX Acumen our by faster. And to million Critical global through strong and prior algorithm. patients Critical quarter Growth to HemoSphere, year. led adoption

Scott Ullem

Okay. Thanks a lot, Bernard.

detailed provide of full provide I'll wrap-up XXXX. and today, guidance well the our fourth including quarter as of year as quarter results first XXXX, So a for

with growth. mentioned, achieved earnings strength we achieved We performance groups. per product of of were $X.XX. our which better-than-expected We across with pleased adjusted $X.XX As XX% QX year-over-year billion total Bernard sales share represents all sales

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

$X.X expect we of Surgical ranges all sales Critical XXXX for TMTT. previous billion billion. million billion. of billion exception company $X TAVR guidance and maintaining to $X.X $X.X are the moves of of in big of foreign sales Absent Heart total Care sales with $X.X $X.X of exchange, Structural sales $XXX to sales to to billion We $X.X billion our billion,

range. EVOQUE, the expect $XXX of be at early FDA million we full guidance TMTT approval for sales our year now $XXX Given higher end to previous to million the

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

same the profit FX. profit a gross margin quarter, significant by XX% last year-over-year period reduction impacts to adjusted gross from compared exchange. impact driven For year, was foreign Edwards' our margin was the XX.X% Last was year. fourth in lifted expected This by from

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

continue investments was to as field-based increase activation sales. This quarter our we expect fourth G&A clinical trial continued be efficient the grew percent over in to year the valve and activity. our full increased invest of a transcatheter XX% focus including innovations, We increase to expenses of personnel on SG&A million sales development as in prior XX% in leverage. result year $XXX XX% XX.X% XXXX initiatives to and patient or primarily the of Research and

continue For development year sales TMTT of generating more to we with XXXX, growth and technologies research invest new the evidence be to expect full XX% TAVR as patients. goal and the even treating developing and to XX% we to support in of

fourth our Care. quarter, approximately Critical incurred we $XX of announced of with onetime spin-off associated million the During costs previously

year-end. throughout separation Additional onetime prior the at incurred XXXX expected be costs will to

taxes. to Turning

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

XXXX, the or our the rate For special of impact XX.X% tax full excluding year XX.X% was reported items.

benefited tax. the foreign credits U.S. primarily in rate tax on income non-GAAP lower-than-expected and quarter remittances Our fourth from

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

guidance, cash as full quarter profit prior fourth cash was year the the of $XXX to activities margin to free points of or $XX the was our points the earnings less million, million million, spending as million reported to Foreign growth of spending capital quarter defined Relative the Adjusted nominal quarter XXX activities operating defined million exchange fourth million fourth compared $X cash intellectual free $XXX from quarter excludes flow for of flow per the on fourth year. a had FX property Adjusted $XXX less flow operating capital payment $XXX cash $XX related million. million. XXXX Medtronic from by year. sales flow October XX $XXX flow rates decreased negatively rates by basis to compared basis our cash prior impacted share. Free gross for impact FX rates agreement.

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

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

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

through pre-established a fourth XXbX-X X.X During shares million plan. accelerated the we repurchased an quarter, agreement and repurchase

a declined result, As shares diluted quarter during average million. the XXX to outstanding

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

current our repurchase that, remaining We $X Bernard. with billion have you, to under back approximately share authorization. And

Bernard Zovighian

progress advancing and new therapies made significant proud the profitability. In performance of in we Scott. solid patients healthy and breakthrough delivering for are financial you, Thank we conclusion, XXXX,

enrolling excited launching This significant We beyond. XX. clinical to ALLIANCE in RESILIA, about studying XXXX will anticipate groundbreaking XXXX. TAVR, and studying patient give pivotal and advancing patients of adoption accelerate needs, in more trial and Ultra the along trials. data a important drive are These present trial continue our growth multiple asymptomatic confidence next-generation we AS we unmet In us year, with SAPIEN to technologies global from pivotal SAPIEN early TAVR, ability breakthroughs even X

approval innovation. in closing, executing and of for commitment Europe and remain create our TMTT, growth and all including expanded And expanded XXXX. and that strategy European We Class the expand to will PASCAL adoption and focus confident key Mark. longer in for also opportunity, SAPIEN term leadership. In non-valvular end the the our stakeholders. With of plan our introduction forward which valvular are value we MX number Tier reflects patients to PRECISION look believe of Care, back structural a of of the by you, enrollment in global Edwards, we Critical developments completion healthy X Surgical We heart our to on that, in committed U.S. sharpened EVOQUE, to to our and

Mark Wilterding

With take everyone's Thank you Bernard. questions. very that, much, ready to we're

please limit allow follow-up for broad to to reminder, participation. plus the of a one As number questions one

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

Operator

Instructions] Fargo. [Operator Larry question Our first from comes Wells Biegelsen with

Larry Biegelsen

I like start to Congratulations there. feel on of the U.S. the EVOQUE need early in approval I

hear you Should the we to talk I follow-up. And reimbursement about price your should the about had expect to NCD? an one commercialization Are file premium? to plan I'd ready So now? pathway expect love for And guys EVOQUE. we launch you talk you

Bernard Zovighian

Larry. Thank I hope you well. you, are doing

will start Daveen me to some then and Let ask here. add color I

is way TAVR. this we one first, did are we So about thinking in the like

are make very novel therapy, mind We are to foundation want -- we going this we expansion. having sure building that long-term for in to introduce

we're we physician generating outcome, established more the evidence, Europe. payment, have to So in training, in making be sure coverage, patient and excellent focusing going on reimbursement U.S.

are we view. to you sure we years. some same it did I'm TAVR of in The long-term last in share your But having So plan. a again, want Daveen, here way XX

Daveen Chopra

first Bernard. many Thanks, the breakthrough coming transcatheter life approval course, very through by regurgitation. the innovation the start of technology tricuspid in saying, are excited from suffering pathway. definitely. to FDA I'll is this of we This patients the U.S. by obviously No, change the

cases then technology, to clinical going planning rollout we're clinical on will support centers, date. to And scale over move a over said, grow in those case a team model, really that the who vote as going As done rollout And as we we has team controlled and Bernard a in now -- really look who been continue to are this with great focused have this clinical will training our of X,XXX time, been of start have outcomes. forward. at we that kind are of trial to dedicated used in on centers. We're

question NCD parallel Specifically, kind -- there I on EVOQUE, the question about with it's timing. a think of on review I in and your a heard Obviously, technology.

CMS is we of them process. So and help with the to their to support kind are on of working continuing information own their work kind on to national provide coverage process,

will all we as you that. that, So we'll -- guys the more loop in hear on about definitely

Bernard Zovighian

Larry, So what here. you can see,

to view that we want a long-term like on did everybody space shape proud way in a like, way of, we the one. we going We a have in be We is this shape that as for to TAVR. very

Larry Biegelsen

That's helpful. just seeing data for are the at your a months statistically And and X is one Daveen, is follow-up What on you. full benefit for at II important significant And likelihood the presented XX mortality that reimbursement. year adoption how or thoughts of TRISCEND TCT. when

Daveen Chopra

mortality, Well, talked very I and right about, favorable regurgitation. failure heart think trends now, as obviously we've in were hospitalizations trends course some of the shown tricuspid all And key those we've that to help on and fall to year the out our Obviously, TCT show. in hard come it's data speculate follow-up, our will what will us with approval. that of full set lead data X

Operator

Our JPMorgan. question next with from Robbie Marcus comes

Robert Marcus

especially some adoption be see new help what pretty Great. a speak Congrats tricuspid nice to I upward in population. past system see slower over trajectory. in maybe up patient Edwards of and you years ramp that just a the with mitral the it's whether expected. little as follow can education, in sick maybe seen will disrupted just But it's Maybe to bottlenecks some what therapy. just tricuspid imagine. speak just Maybe on data. a a really few that. that TMTT to There We've replacement, to bottlenecks you COVID than very do Obviously, the the totally general, on ramp

Bernard Zovighian

you, Robbie. Thank

in start past little your expected Daveen years. about about me the let comment in So slower earlier a And the then bottleneck system. can talk on than a

patient but if diverse. mitral ago, study vision, you X we it, together And technology, the were from population, that be since think not this tricuspid. proportion knew of one did years repair are knew only we treat So will And a therapy, sufficient. put complex small beginning, and about very we can device, Repair very pleased and some beginning the that they patients. only about we we this since PASCAL when one technology

vision why is a portfolio. this we So have of having it

more -- on So replacement. able right on to going we track what altogether to are have this Clinician patients. now, are we portfolio an what what going we mitral get tricuspid side, to are is will the be see, And we a also we treat is see what are acceleration. to

to So XX dynamic the in next different Daveen. going But last very XX is years. the again, the in dynamic than the years be

Daveen Chopra

quick couple comments. Yes, I'll a make of

one has tier that. in well of as as we're that we replacement patients, therapy number excited large continue and the because a replacement, see that where build especially regurgitation other see really largest of alike. starting a the in of up tricuspid and First, really practice. There's are Because groups really modalities to as the really technology the as centers been tricuspid other tricuspid note patient potentially number grow to the like in that potential then longer huge we to Europe has on top patients. core technologies trials are treating a is we treat new to We've of approved heterogeneity add patient see in still seen

to in you more technology see more awareness getting seeing disease you see the the start of the referrals to you bring As grow patients you heart team. market, and and to

as grow market. space, conference, activations those see can how for the future the be an TAVR be new tricuspid continue that's investor activation. start with much patient that, correctly of so Larry and of to tricuspid We'll we the both from some in group, building from diagnosis see leveraged able be And centers. to see to we that therapy learnings what able correctly the referring with talked patient becomes teams. TMTT people see referral U.S. at about also, in And in to imaging out will up there's we to the potentially will them happen And mitral all the we that we to exactly that reading heart the opportunity, that in we're And and over

Robert Marcus

on Great. I the appreciate market. Maybe TAVR that. one

How the We few the from year put includes growth next later fourth forward? going do the data exciting the about years market up double-digit you keep do high TAVR that what think most intermediate what TCT. helps How how from you this just think you you coming risk you about what's the And have Do Is part. at does Or early for to can about coming guidance adds? think growth? quarter, low, double and with what do severe? TAVR that's growth digit? then that in what and asymptomatic that help accelerate

Larry Wood

Yes. a This question. That's great Larry. is

out I fast think in a people a the trial. do we're progress of of and to waiting. test? I a going lot lot learn how first why happens this questions is subjected just when what what are from percentage terms people of asymptomatic patients they're thing stress unknown truly There's to think there to

really at I symptoms. is it through. guidelines the the the therapy. spent time biggest in about, the patient and and the talked of time just preventing make this as it overlay unfortunately, lot about of to And to people actually given a the deadliness investor never that disease, moving conference, And it's a is, patients diagnosed of long. really a gears to is think we've a lot I of lot the interpretation, from the get And from treated all thing of stand the

this through. TAVR guideline stenosis, people actually can now assuming where get aortic severe patients apply aortic early it of that additional that the just right But it's with criteria to will with just evaluation remember, trial, and we streamline it move about can just and symptoms treated. of only process XX% stenosis I won't successful, think require

just huge undertreatment a there's asymptomatic that. adds We to think So now. right

Bernard Zovighian

indication. addition, evidence. XX at what guidelines. TAVR, after bring not and Robbie, we in X expand is This the committed trials, a to to to are commitment -- change for these to progress a Look super In like TAVR. early our is also potential more, sure big learn but still To I years of

a see as it, exciting going in we are the believe years, some in very for But So space, we like XX committed. the we leader happening. in to TAVR, sure, are that next here things I

Larry Wood

I on right. also think to bit TAVR, new of and little treated in a Yes, think a days earlier not I evidence data having the to patients sort that's And of awareness think only up it's we're get I new returned but planning the where raise of steady cadence don't and open new today. treated get for that trials new therapy opportunities about currently continues that to

Operator

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

Travis Steed

over EVOQUE about period. multiyear talking Maybe a

curious that And or think so that that the is market far, you better compared seems market, replacement mitral than to do Just you think it you faster we how develops have slower. doing clipping. goes about when think the data like

the market tricuspid? know of think if replacement don't in I So in kind of and clipping where you the see would about you mechanism clipping action, why replacement be better than

Bernard Zovighian

Go ahead.

Daveen Chopra

Yes.

off guess with of technology. about start your the latter question I'll I the part So

still really see with its kind we to really replacement able of mentioned, kind vast see tricuspid As in or may to the of I other closing modality replacement where regurgitation, But but tricuspid still may of sense. the anatomical for considerations, the going disease majority applicability regurgitation whether opportunity you're and patients an make help patients. tricuspid other really treat a -- awesome of being again, large many it's state that or make to able of regurgitation, And not be we technology of improve and there's where eliminate quality where life. a tricuspid we on sense there's see their regurgitation, those to broad heterogeneity replacement based chunk patients

develops to about the question how your market related mitral. to Back first

we had rates treat can kind some We grow larger opportunity disease the that you kind similar think, think that think of continue awareness of market have rate, think in this. the a the patients. referrals entering I very kind proportion as continued of will probably exceed see very bicuspid with a now mitral kind of market, strong we especially a think strength time, COVID. of at of the mitral, market an two to to slowdown continues, modalities strength the We in and during in at early

Travis Steed

when the then follow-up, think there on view SMART market? last change just if good, on a And And curious curious of also, competition your I'm on Helpful. guidance? that you If Does you trial. XXXX? market is in long-term was had the there's into XXXX. kind the competitor the week, an data last impact comes what there kind of to baked news your

Larry Wood

and I With we'll and trial, that's show. going valves SMART to trial, wait patients. about multifactorial for a really think TAVR I to their think regard select But have thinking the the we is to And key thing the see don't decision. physicians just what it's how know

I mortality all the look I factors the on rates, consideration. are interventions, to driving don't compared patients. hierarchy you some think that future other one certainly And But to the even of hemodynamics consideration have think stroke, probably for at is things. it's those higher

the because and me And new terms what that. late. was In know the there's a the going approval ramp XXXX impact revised the of what have therapy. We XXXX speculating is. real -- on come time expected have value approval in to We'll timing space, on to in didn't a was a to lot no competitive we it the is see

Bernard Zovighian

valve, a to are easy. not And addition, reflect in me And year it when we think bit little a about my about being as first like valve, making half I I'd company. CEO, in Yes. where is as a as

patient of luck. this nature not needs, is Given the

years. the We year, the in focused knowledge. for or we experience, than are XX very are we and many a What after and many have bring X past seen, years more coming leaving platform, in companies deep years market even a few X there years, committed and

the with space more than a R&D long-term commitment, So X,XXX very specialists. engineers, we R&D, leading are significant

of proud uninterrupted And leadership we in to going space. the are continue We investing. our are

So take we very evidence. technologies sure, very and for the we competitors all about seriously, leadership, about confident our our our about but are

Operator

Wood Morgan Our next question comes from Stanley. Patrick with

Patrick Wood

back some you post the you maybe very in like and Do about good share you've for one feel Amazing. market, taking on on you the TAVR I were taking and It think share side. guess sounded general. Japan back first some trialing. that been

be great. would there give could you color any Just

Larry Wood

Sure.

process, to comes the impact the works had think certification process new what move when just for way happens and us. through I having an people certainly into Japan because technology of that that

back in that faster pleased trialing But and I market look people the really that we're some of forward and to to very like very but lower sort relates a the moving with -- much we QX continue we market. than grew QX, growing Japan And our kind that think to it's is a U.S. the grew ending and this in of because on, than think penetrated something platform. market of how I Europe. to it's places in goes

that us. So as we growth continue see a long-term to driver for

Patrick Wood

the because sense a to That's your that's weight on, getting very And with faster market discussions it in a the helpful. expected. then do with the but follow-up. everyone. what experience one faster-than-expected this data as I think of obviously difficult was quickly think of products might comment FDA? great than you placed what Do on the in of for be into or been area not And there get like it comfortable they just approval EVOQUE, you

thoughts So any there. just to get curious

Daveen Chopra

sure. data results us TCT. but This larger pathway. in probably gave the were we questions, this mortality. this as the of it's think to received the this that the through Heart FDA kinds And innovative the of believe one. pathway patients at those -- kind statistics. And other No, I time, favorable our we from those mentioned, cohort come we this we have that we them trends tricuspid say, as the oh, their was yes, the descriptive really failure was makes of breakthrough And and hospitalizations, cohort working of answering really and same XXX all-cause where back need to FDA FDAs with that where an re-interventions, presented presented it our and at cohort, jump is we of probably larger was Yes. breakthrough showed panel a an again. that We led kind basis approval advisory approval. trends sense. don't other Daveen approval I'll in Obviously,

this continue so of so as not great to did we the just and training, of that more outcomes. an launch at full therapy look data, X-year clinical for trials kind with And us, data the planning long this therapy kind presented at supporting cohort of like therapy we going very TCT, careful that therapy, all ago. help as We're really forward, the full the patients evidence. a we're just data, right, of the really have have of breakthrough to will this that And build kind plus initial not we physician XXX for this cohort We're patients. data. And see great deal to continue how great other going show organization we out excited be could be to can TAVR for cohort the the on that

long-term this patients. for so excited what that means I'm And for opportunity and really helping

Operator

Our comes from with Vijay Evercore. next question Kumar

Vijay Kumar

Congratulations stat I'm development, on totality like the Maybe curious about here on to think do a data. on valve when here. is you comments there reason was sprint nice EVOQUE, some in last forgotten like we on a see the called there's the this valve. significance question you made mortality. market a bar, of But Daveen, Like, about need a

what physicians would if how curve versus So don't like take on I in your seriously, is example, maybe know up I'm contrast could curious compare adoption I a but look wakes love comments. the good to TAVR this valve

Daveen Chopra

I'll totality off on Yes. bit little start first No, the a data. of

X,XXX There help amazing this tricuspid indications that to all gather cohorts to why data to other development. who looking on what option. and discount mortality, that I along failure Now key of things of their well. every that's health favorable improvement. data our numbers about got we've, as life data, I'm does can patients. And have starting -- talked really improvement a hospitalization, the life see to with patients life. re-intervention. kind the Those up and trend that point, to in This But And all patients hospitalization. status. We've matter. And pick And data do are outcomes for walk all this do these quality those studies. we're in other matter consistently before, rollout, to points, how help and patients we've hot market at of who we patients mortality, play And patients grandkids, that tracked able huge EVOQUE that training, can't going large breakthrough to just about, out difference in be in But statistics help trend, stairs. And of cohort go for the concept, up patients. beyond physician in it's right, quality clinical the mentioned to kind as It think study, are failure other day your makes gather We're in continue going the is we've We're want continue heart controlled are the going they show trials on with there matter, with in life. trying have really we various their not really we'll create really the continue [indiscernible]. as of does market I patients think, this careful feel don't we these EVOQUE, favorable shown options over continue do really EVOQUE more don't that the implanted seen to I technology future. the really the to excellent that in things the large data matter to the data will and great an on

like this can do. mitral, me for what speculate maybe to compare about TAVR, will it's same but so for I'm question it And hard the how excited technologies

think so grow to much market. there's this I opportunity

Bernard Zovighian

Daveen, And later, about still we are excited. Thank very said. you, years are we well TAVR. generating evidence. Think XX

with come We a still innovating there digit for the We are that to in to RESILIA double healthy globally. XX. still believe way is Ultra TAVR grow many years

same. here, TMTT years, probably here years TM it's the XX work, that so in for or -- X thinking the is not next thinking It we are next XX the for in of. So

Larry Wood

Yes.

a is the Just time but stuff, people focus spent the with payers space, that living in the deal get really pile feature with that, on having spending living and spend, TAVR groups on singularly time I poorly on a when with to to them. focused not there's regulators mortality so longer, it. and almost of and But much we patient lot

benefit, therapy life If improvement the we've you quality told exact and mortality I the when really what this expectancy, of that dramatically think And where them life you valuable seen like you life would That's but quality more you to can can their run them. improve. they that's far same with get of have had home get TAVR.

significant But to benefits, discount for quality we're on. that's of trying the so really really I they're what build patients. And wouldn't life

Vijay Kumar

you Scott, sheet. that? it's below on this helpful. gross on line there the for And That's impacting the step think driving guide, Is maybe, midpoint, EPS what's I a Or sort curious margin Understood. one a EPS? that's of quick is issue slightly QX up in one that at or OpEx? I'm below QX

Scott Ullem

revenue the just you why reason the a get exceed those it's in according to period $X.XX overall, the OpEx end forecast. growth but will year, R&D SG&A of that's the Yes. we expenses. lumpiness couple to and remember the full up line of from we in level But and relates range top expecting growth outpace that what And cadence. It's of bottom record EPS the quarter. increase it largely we're things, to the to QX, our with important the quarter-to-quarter line with different of the fourth midpoint through for current

Operator

next question Our Jefferies. with Matt comes from Taylor

Matthew Taylor

that U.S. to it an gain wanted having impact thought if anything? that any I international you you delays provide to the markets? Does opportunity the on would you competitors share? have change Does in ask any your it

Larry Wood

impacted markets. share is. we've certainly, We'll international what has We in cases seen U.S. impact to the where see international -- have data

signal the data. I additional just data is is. there's on their released. All data that a and been think they're delaying the think reality no been what simply it But for just there waiting depends I is has approval

much I how know So that. going people to are don't react to

that is impacted. don't in the get especially clinical on other that for to how data. goes pricing that significant oftentimes, The into will much know more Europe the purchasing a there's purchasing and are there's than And price it's favorable because people discount. decision I thing

Matthew Taylor

different activation the I call-outs you just kind a on one the I of a are mentioned doing Or you more there? there. call. ask on patients doing this noticing of I anything new few can -- it Are And know the you is you. follow-up times. was same? and Got lot of

Larry Wood

continue I think do things. to number we of programs. of running a a new lot We're

systems all I the a I lot investor one where applied patients moving we've really enough major of variety we of -- there. can the like say is, that things and through absolutely in and just a for patients we've I the They're I the things know the and can those tell frankly, there. you undertreatment reasons. not there's work are talked health speculation the are system done on conference definitively Echo on about skepticism, rates think to at AI of reports,

fashion. we system but these we're are try through to to second patients So the you on and have to people them the working about off move do to first sidelines process to and the thing then the what in thing and a drive continually understand that things multiple them is we patients have have the you programs validate, have do to activate evolving treated. to through those do it, them you literally get through, to is to optimize And get streamlined move

Operator

Our next Matt comes from Barclays. with Miksic question

Matthew Miksic

I could. one margins, So one and on follow-up had EVOQUE on if I

but EVOQUE it, if guess, one us million. need rate like know follow-up. is started of year to just of end in not -- brokers expectations then And tell know knowing the And have we sort X about in run the so moving your the to months what to we the we $XX I this get I that on the about to Does what now, point So your put TMTT U.S.? think X, we a $XX high early. came fine you range million from middle about for

Daveen Chopra

said it, was question. a kind we No, right, of window. estimation, Daveen the midyear Matt. again. of our of if of first at of midyear got look kind much couple the kind and you for has It's Thanks initial timing months so Yes,

expected. than was couple of months So of a we by definitely earlier this up kind

the obviously, is, we us moving we'll based that and now, can how as continue bit. in a to adoption what up rate little And centers, we what on we be see do. start And we through confident so just think but help know through we bring training EVOQUE this fast get

other for I'll good doing whether ensure which approval. that really that is like helpful they're to you and get online hospitals, a job make I think things help date add-on the comment and of October change payments, doesn't late are right, kind adequately technology approval comes profitable new X, earlier or

we as like So needed. give some as updates at and grows we'll continue over it factors adapt But that. to year there are the if of and look course the how

Matthew Miksic

you're That's follow-up question then that just activities the on great. now getting And the the in field. on margins after and the Matt's

So quarter, fourth of folks in, the these spending there. hired guess, which you I step in in is part the up

that. you little in seeing that in QX? the a bit so from an that impact benefits far investments Just you're wondering, does those Can first, about have talk

against are field. investments? done set your Second, Scott, those you the put sort investments, achieving now into additional of those about spend earlier, continuing and you of Or about a that kind you leverage are it's like leverage to against point

Scott Ullem

for of but as well Yes. Thanks the to continue presence out overall just EVOQUE started both force as question, we're we field Yes, for portfolio. with expand building the getting Matt. our our TMTT

team this not a in so foundation And a the field, investment an is in of of the beginning building end. the

team. in and aggressively, invest the And to TMTT. continues resources, continue investing going just grow You we're our to to we're more should growth expect that to to as resources grow limited the by TAVR well. support that not that's way, field

though, down doing, administrative gives as it and at Edwards the general leverage from us scale. get put has And things expenses globally. some footprint, to global broader carefully opportunity is a One we're looking of an

be so to as And efficient as going to on we're making that being look that and we're sure continuing can closely be P&L. at we the

Matthew Miksic

these field And you from is then did any QX? you results and that side, still patient efforts come? in activation Or that's something the TAVR activations see to Okay. feel

Scott Ullem

But in activation that we fourth have to from and place. efforts drive those other saw the It's think isolate TAVR. the growth growth the continue have no, quarter helping initiatives tough from we support patient of benefit in Matt, the to certainly underway I to some that that's beyond. we

Larry Wood

on be through mean, that patient been patient last, of I our think We've number efforts incorrect resources, have or cardiology to our do I website say for other through events and campaigns, add to starting this, X don't doing some general know, of I of stuff, we some driving some now. Just years a to patient this. dividends our activation the digital the just been of activation it'd our pay X to things awareness are

along activation patient way. has been I all the contributing So think the way

gaps. what tapping system, a and program these talking really patients about now, we're approach more but that realize is in think to that sophisticated don't untreated those bridge the though, to much really now our we moving. is are know hospitals not diagnosed know patients they're And we do how And the I there. We in really with an echo, that's they're activation because are they're where but there.

matter And of system. so getting way those tapping right the it's just accelerated and in the the into patients a through

Bernard Zovighian

say is, in past many the though have years, few fair initiatives. What's to we pilots, many done

What we learnings. is many so scaling. extracted have right now are We doing

scaling and spending. are We

year, the resources spending few QX year next We last and in years. this are

are So many to more receiving so and need there not in patients believe are more we treatment. you because a going see

Operator

Research. Pasquale And Chris next Nephron with our question comes from

Christopher Pasquale

seeing from rollout. I with patient EVOQUE of but more they're as of TAVR, you just many of their heard to encouraged patients important an actually was lot I in think the these not part regard TCT, back at to hear I tricuspid mention practice. physicians a activation, also

work large have think channels? to initial already are for referral these and a waiting you launch do lot you Or you expect do patients to as a of here, treatment? establishing identified about So do there the of number think

Daveen Chopra

Daveen. is No, this Chris, appreciate it. I

small kind think really toward much I happening so longer of of really being and about and heart and more time in my we is a about getting centers of a helps things it's doing the now, how and about of activation thinking how that patient activation up things, diagnosed patients organic reference make kind lot right of really doing building being now. some least is right? running. I'll been but think midterm, most that And help number do for yes, way referred we're has think over over TAVR in of is drive of where, patient capabilities and I our a that or We're testing kind that the scale TMTT our there's is energy teams. Well, right in TAVR growth other are term, about learning at to we the kind we point

So there center. lot are of a patients the in

very It If how you and quickly. enrolled, the look at trials II fast our TRISCEND enrolled enrolled especially really trial.

kind So there's efforts. we of continue we're looking kind options. that grow patients off lot over know and those to time, patient as now TAVR of a going looking options. diagnosed are for leverage try They've and activation of to But groups been for to who we build definitely of

Christopher Pasquale

Ultra X RESILIA Are the RESILIA rightly do price similar premiums the in a and for SAPIEN is the And a the got rolling U.S. But And products get adoption see you've then same helpful. MITRIS what you so more what I think That's out focus, in Europe U.S.? those you market. products. we as price-sensitive in both couple lot on can there. of a think, Europe, in new

Larry Wood

of anything where was. Yes. it I'll start to premiums in starting the different he price different markets Wayne on if can. and are the because price has kind then add, depends all The

So we did for in in the we than premiums larger went what Europe U.S.

that's so more issue. more market, of an And price-sensitive a obviously,

really add? RESILIA-based total. U.S. think this rapid we're our on Europe. don't momentum see in in platforms I did have more seen gaining But we've to our in So growing of Wayne, you adoption anything to therapies the continue we know And Resilient I

Wayne Markowitz

Maybe you those think of a our the tremendous was seeing treated just of RESILIA global patients RESILIA out also add lot adoption are best be markets a emerging technologies, of just growth the surgically identifying premium that we're with I'd finding about and the portfolio. And can if markets. couple things emerging of

premium with effort, is it's see to of even but been certainly out a too. the growth markets strong technology, encouraging global which emerging So

Operator

today UBS. from our Danielle And comes question for with Antalffy final

Danielle Antalffy

just the isn't in first a trial to I is into the there but stenosis. certainly time for question a question you quick the moderate trial guess I it's that But And hearing anything there just there on opportunity signal. us what progress for the know than Larry, this potential faster on one. enrollment. you number more this broadly, for enrollment trial unique about I uplift aortic positive enroll expected? allowed anything we much read market. Was approval, see about the based speed of that mean number once the Great. to across this potential And we're the mean my of speed could you data on guys is, so two,

Larry Wood

Thanks, Yes. Danielle.

I think marker the to trial clinical enrollment, is I for opportunity. And enrollment, trial certainly clinical always that think think, important I I having speak does think, opportunity. an rapid

most do TAVR. fact to still surgery, the Series that do stenosis. better to everything been I to better And severe isolated think trial has it the it in is that just it work to done speaks also aortic of we've is Partner is,

the and are at have actually should enthusiasm Or patients could a is doing and should way before I about -- attacking consider we And we I be there's be lot we think that a What even those disease evaluating end and now benefits. of literally in think until stage excitement waiting two saying, sooner. patients as the different anything?

point. But high-risk and having risk thing the I is of when those today. Because moving as moderate are if approvals, patients risk for people in risk, as we are moderate show one accelerant important patients. it is, in seen intermediate I the biggest aren't intermediate, moderate to was are saw a that severe in a think at high patients, can have those treating to if we've literally many advantages benefit the think for patients, for high patients intermediate real other first went there these we space. The accelerations think we from we twice debate severe real could I the has patients is there's showed this then it automatic And that then we provide the risk like, about that

we patients to long steady term And think and this And with drive so later, TAVR the later of that cadence to a coming data opportunities market, be and cadence That's at I steady then trial. about when year get about treatment we just talking going we important think improving we're TCT. years early is X.X couple for of data, progress years, of the informing rates. think, continual

Bernard Zovighian

was did about great the year. about this our I across a I what X globally. So very year year. product last groups am Strong XXXX performance in XXXX, we I'm closing, proud When super think excited.

to trial are technologies, clinical We going and surgical. multiple in TAVR, breakthrough TMTT have

way to Here, patients. a basically did EVOQUE shape we so many and we a TAVR XX providing same have in chance. with the physician years TMTT The to ago it treat toolbox to space

is opportunity very unique very taking So we are seriously. that a that

The spin-off of critical care.

in also We are executing one, XXXX. on this

accelerate super confident this is to to exciting that I'm are year going be year we going in beyond. super So a and XXXX growth to positioned very and be well

telephone. Scott, Thank in additional your questions continued any welcome Edwards. by So Mark thanks everyone. and with you, I for interest that,

Operator

conference. today's concludes now This you. Thank may All disconnect. parties

Edwards Lifesciences (EW) 6 Feb 242023 Q4 Earnings call transcript