Earnings call transcript Q1 2023

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Operator

Greetings, and welcome to the Edwards Lifesciences' First Quarter 2023 Earnings Results. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that this conference is being recorded.

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

begin. may You

Mark Wilterding

President much, me thank Mike on Scott Bernard and very us Also TAVR portion Global of Leader joining Mussallem, everyone Global and Zimon Surgical the of Group Q&A us. Larry Leader CEO; our Zovighian, and Daveen our CFO; Care. With the TMTT; today's of for Structural of Ullem, Edwards are Diego, Heart; call Wood, you Lifesciences. you joining and for Chairman of President Thank call and our Critical Chopra, are Katie

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

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

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

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

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

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

Michael Mussallem

Thank you, Mark.

staffing constant-currency represented growth Sales transcatheter the a Structural first therapy the patient-focused basis quarter $X.XX our adoption of billion execution with better-than-expected growth in on period. an quarter Care. reflected improvement and our expectations XX% the Heart of in with performance Surgical our innovation year-ago exceeded which first strategy. by and drove Strong along valves performance, of heart aided versus healthcare Critical strong pleased a majority We're of of

growth partially strong the by COVID the impacts Japan the and rest geography, of U.S., world By Europe offset in lingered. was where

also quarter U.S. First a volumes results following in year. in quarter slowdown last in catch-up late the by impacted were some the positively seasonal procedure

we environment While staffing improve. remains globally, a continue the will at concern are that to sites many optimistic

XX% basis. first sales TAVR, our of We In a on stable. were million, procedure was growth increase global selling estimate constant-currency quarter global growth. an year-over-year TAVR with were $XXX prices Local comparable

TAVR grew in In our low-double-digits year, sales comparable. versus we estimate the the total first U.S., quarter prior procedure the growth was and

hospital also As lifted quarter the improved we that were staffing believe lifted by volumes trends holiday quarter catch-up levels. a we slowdown. Results were in in the following season procedure by first indicated, early

about We're launch results RESILIA the our Ultra X U.S. SAPIEN optimistic early of the in

technology is track-record surgical performance advanced well, we to before sales Adoptions technology As proceeding has the represent tissues year-end. the a anti-calcification you of of our RESILIA it in U.S. majority demonstrated and expect Edwards valves. of strong TAVR this know,

patients distinguished our PROGRESS volume quarter Related this, the of our to trials enrollment with We're that study cardiac untreated larger increased presented the valves in first AS. early-stage continued were XXX,XXX month Conference U.S. mortality AS driven ACC clinical severity of all the associated patients centers to in risk. This in mortality concluded the data continue by moderate with and growth SAPIEN that TAVR were of degrees last rates with at AS examined pleased damage demonstrate clinical was studying performance.

the of excluding first trialing competitive severe all contributions basis. which Of approximately Growth AS XX%, regions, approximately products. of with U.S., constant-currency the positive sales year-over-year COVID approaching our those AS. was moderate for the from quarter, rate in mortality reflected Japan, TAVR a mean recent note, still that XX% was Outside two-year grew all-cause and by on the impacted

We low. remains expect as of higher OUS international growth TAVR see adoption to therapy

we although to that growth below substantially Japan, conditions expect we course progressed, the the over In was XXXX. quarter our as COVID were expectations, encouraged and headwinds improved diminish of

Japan other countries. where Ultra the With SAPIEN we X aortic this undertreated country improve stenosis of expect to growth month, the remains launch in large in RESILIA developed late to rates significantly last relative

previous heart disruptions Total It's Edwards' therapies over adoption our prioritizing encouraging Europe, by driven hospital amidst structural and are including healthcare was across across lifesaving despite procedures growth SAPIEN these sales of challenges. TAVR countries. to systems the persistent TAVR that related strong In continued broad-based all shortages. quarters grew platform was Europe staffing

Looking additional optimize valves the TAVR for programs to to TAVR in outcomes from expandable Congress the we next balloon ahead also study European month in EuroPCR on focusing of Data TAVR centers. be data Paris, presented Medical will procedures. benchmark Edwards the on strategies anticipate XX across

summary, our of XX% now expectation given XX% X%to of quarter we versus previous growth to strength In XX%. our first of constant-currency the performance, expect

continue compounded Our during $XX in assumes the this by implies which increase remain to growth that will outlook XXXX, global large that year. annual billion We confident to low-double-digits. a hospital improve the opportunity resource constraints rate

TMTT. Turning to

mitral mitral tricuspid to portfolio opportunity, for to patients solutions. better the key and outcomes. differentiated unlock favorable approvals to We three continues results with trial need real-world pivotal support and a care confidence developing and in disease adoption, on the and for prioritizing driving grow who therapies of positive potential anatomies, clinical this complex long-term steadfast transform the tricuspid value remain to our drivers many Our

premium Europe differentiated the features procedure for on We're growing United the adoption the have million tier substantially, PASCAL and particularly to been and of Precision First launch overall $XX of consistently clinician of ongoing driven quarter in PASCAL in growth, launch Precision pleased by positive, continue the excellent initial we patients grew and system. outcomes the feedback that has sales States. highlighting

U.S. to production are We of and the Europe ramping support launches the

ENCIRCLE one the trial mitral pivotal of forward full year. In data SAPIEN with We anticipate replacement, presenting that cohort regurgitation. the of population this pivotal PASCAL patients. Mitral, enrollment the enrollment XXXX. year In to for expand completing IID IIF the continue we cohort trial and end CLASP with mitral of of trial a patients with ongoing functional CLASP replacement around pivotal therapy we broader MX from this main believe for of to later we Meanwhile, is look enroll options will mitral

continued that by the and pivotal of were enrollment in clinical completed and involved offer end U.S. of EVOQUE FDA Valve we've hospitals the on-track approval tricuspid, around a in U.S., option. trial therapy access Replacement remain II allowing to continue the trial the the of European The Tricuspid TRISCEND for of the approved XXXX to end a XXXX. System as recently EVOQUE In

In TR II the with addition, trial PASCAL pivotal continues CLASP well. enrolling

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

penetration higher our over our than to XXXX levels a hospital robust the Heart, procedures. global Structural as increased by of and products sales on basis in expectations valve some staffing $XXX premium all was million driven Surgical constant-currency across XX% improved prior a catch-up quarter growth better-than-expected year. was leading regions Growth of In first surgery

see surgical of RESILIA the Surgeons momentum We valve and globally. benefits for portfolio procedures. continue to value strong and proprietary tissue replacement features of mitral technology the patients and aortic this both

clinical in the Valve MITRIS the at of of month. Surgeons X-year adoption will Thoracic of trial The American the quarter. first US Meeting our seen COMMENCE we've from Annual next And the in presented the be increase Association data

of in our demonstrate the mitral the of trial durability enrollment began RESILIA position. clinical also We to MOMENTIS

In million and surgeries. sales, we year summary, raising quarter by sales high-end underlying million expectation range. growth guidance an the XXXX, expect to now high-single-digit based valve our our on increase the technologies in advanced our overall We our are in $XXX the adoption heart full driven of $XXX of most to first

basis, In Hypotension cuff from unique strong Index by Prediction $XXX first our IQ led sensor a Critical all quarter our of was Acumen lines. contributions of balanced product finger constant-currency driven and by portfolio Recovery algorithm. Smart X% our million Growth increased featuring adoption sales and Care, on

our opportunities. million Based $XXX future and strong our remained catheters the Care also $XXX monitoring pipeline performance, artery million to million first of our the healthy XXXX $XXX previous pulmonary in versus for platform strong of HemoSphere a on million. quarter full-year Swan-Ganz first to $XXX expect Demand sales quarter Critical now with we

patients We remain excited focus to decisions our and take to designed Critical families continue Smart home we technologies to as their can Care Recovery better help get pipeline make our of to faster. shift clinicians to innovations about

Scott. to turn And call now, over I'll the

Scott Ullem

lot, a thanks Hi, Mike.

in pleased impacted We by historical with to are product particularly balanced well, expectations. the regions January and start our to groups QX consistent All the very more of seasonality Japan, COVID the which was were exception and was all with performed the rest our relative growth lingering quarter of year. across headwinds. sales by was strong

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

other was provision agreement, per our our A from was reconciliation $X.XX partially earnings and release. between items sales included for and EPS today's will by compensation. adjusted stronger-than-expected a which speak by for performance-based an property is intellectual and higher these impacted Contribution to Our offset later. GAAP share performance full I with GAAP

guidance For to now be a $X.X our We $X.X total an high-end prior sales to based to Edwards, range now year, our X% increase at billion growth expect to we the on XX% XX% billion. of constant-currency basis, start year-over-year strong of to previous the on from expect XX%. the of

to Care sales moves Absent million and to sales of to full-year expect exchange, foreign TMTT $XXX sales $X.X we $X.X $XXX million. material billion, million Critical of now billion $XXX $XXX of TAVR million in

be we high-end to guidance Heart, Structural Surgical million $XXX now expect $XXX to of million. range previous For our of the at

be to $X.XX. $X.XX quarter expect We're to projecting billion second between to Lastly, EPS per be second we We're of now $X.XX full-year and quarter also sales and adjusted $X.XX share earnings $X.XX projecting our billion. adjusted between $X.XX.

I'll our details of now results. cover additional

This first driven favorable to last our expected, was by in the a was FX. in XX.X% profit reduction less QX. quarter, as adjusted For the period year-over-year slight from compared gross margin and impact year XX% XX.X% same

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

quarter strategy. sales, field-based year Selling, first yen transcatheter were our general partially in growth of personnel against and the the weakening over and primarily expenses were by the or of in investments the $XXX investments reflecting euro support dollar. million, of increased the These administrative in prior XX.X% offset

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

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

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

to Turning taxes.

benefit quarter tax rate Our reported reflects a XX.X%. from this excess tax stock-based XX-basis-point compensation. rate This was

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

this agreement to were intellectual to products. with enter regard a which Medtronic not in structural certain we covenant XX-year property an Earlier heart month, pleased to to into sue with agreed mutual we

previously $XXX of but will which that over one-time Form be Medtronic it file agreement to will agreement XX-Q, paid there year. will which limit of been a disclose, In we reference time. half We a the as for our IP new approximately The other and the a soon. we amortized expired half million, we has the charge long-term had consideration recorded be in last what terms agreement,

quarter rates quarter by FX first impact points profit earnings prior million expect exchange $XX XXX the full-year XXXX decreased margin percentage XXXX. January to rates Foreign share. At on sales had guidance, points, rates, first XX an FX as basis or approximately the our compared gross year-over-year by prior per growth first negatively impact to compared to compared continue our sales rates year. Relative impacted to current minimal flat year. quarter we reported to a to

for $XXX million capital $XXX million activities cash operating cash Free quarter was of flow from the defined first flow of $XX as spending less million.

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

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

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

accelerated an the as million quarter, In repurchased programs. share through we $XXX first stock approximately well pre-established XXbX-X agreement repurchase in as

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

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

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

XXnd joins working And a call. before ends step of But the call with both our at back this your We're me on it that, it's you I I'll to and on in in together, this congratulating everyone do, hand XXth along of Mike. every I now know year privilege way. been earnings

to leadership it's support the CEO and inspiration of investment employees say also fair me, as to know an our Your has and been I the Edwards community.

Mike, So back you. with that, to

Michael Mussallem

Thanks so much, Scott.

truly also great and the a valued lot your partnership years. I've a over It's means That segue. trusted

part As we've CEO succession, and invested confident baton. successfully serving President feel responsibilities to Lifesciences upcoming X. January I Since planned time the of Bernard of been transition the Edwards has all then, as our since passing

that of hands Board's my proven and company assume expect great new the leadership. Bernard will I CEO and the under I'm will I'm with transition selection confident role. the prosper month, as and Board to in to the Next of role Chairman Bernard, is Non-Executive excited his

go Q&A, ask say But few I'll Bernard Bernard? to words. to we before a

Bernard Zovighian

Thanks, Mike.

feel has and care be company breakthrough I for extremely transformed leading this to world. pioneered special fortunate around that the technologies patients

During has for over Edwards transformed the been years. partnership the generous support plus last the planned leadership having I sharing executive Mike also transition, learnings Board experience, well of am and in the the successfully the grateful of extremely and month XX team. five

to had world. and and I I've our confident recent discussion have listening in around months, even the future. away our more from the pioneers meeting trusted of bright our come pleasure Edwards' In employees the patients,

lives. their that we will patients, will impact our to breakthrough positively advance innovation For continue

evolved, While and lost Edwards we grown sight we here. are never of why has

goals will strategic We we foster everything a and our and drive on stay patient-first long-term focused culture do.

We on needs. healthcare and will unmet physicians, large further trusted and requires regulators, and goals continue build we upon take innovation ambitious our to know with partnership peers, and providers deep to strengthen innovators, address partnerships

complex. Transforming care like is do Edwards at we

where employees So impactful enjoy committed really we remain culture a to their work. our fostering

Edwards unique, global talent. team. our bright to inspires be innovation dedicated I place Our strategy motivated and succeed to and organic want attract grow that to requires an a expert, continue employees and

heard from Scott, will our a sales we higher on meaningful you Edwards that growth be expect for as care year and and return more As important for to an Mike XXXX patients. to many progress we innovations improve believe

value Looking pipeline enabling for confident beyond growth. our and and innovative that healthcare systems long-term create XXXX, patients organic I remain strong of strategy will sales therapy significant

we create strategy, that will exceptional Finally, deliver shareholder as I innovation am value. confident on our we

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

Mark Wilterding

Thank you very much, Bernard.

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

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

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

Operator

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

Larry Biegelsen

to this wanted think minute know retirement. seem to when clearly take right path I your a it it a of transcatheter go wish and you been and on I I think on at you afternoon, calls, was to what was and you've to Good the that XX the wanted for XX but obvious of may take your Mike, accomplished I so well now, I've you down valves thanks risk say, just that big Edwards say to opportunity I to question. we at taking pursuit decided decision. just Mike, want congratulate almost just

now. again, I'll Mike, congratulations my and move to on questions So,

to I'd start TMTT. love So on two just with

much PASCAL OUS follow-up. color million. hear U.S. contribute and first the love launch U.S., the have and I one little trends, the about just a the results any Just to quarter, on of the TMTT on in bit $XX does how the I'd

Michael Mussallem

Yes, why I started. don't get

very right, together a Larry, me. from investment that's we've much appreciate meaningful journey I you're long to so And thanks all, and the of support really First the community.

answer don't to turn Bernard of questions. it Daveen why I over and So sort to your

Bernard Zovighian

Yes, Good sure. Larry. thanks, question. No

You know are quarter pleased very with about TMTT, first your we the results.

Europe also approval got imagine, can you before for Europe way before and Precision we we the PASCAL U.S. in As started in

So beginning plus, the want I going at Europe, now it is also, but if in for here? in it, well the is of and to quarter been we know, is Daveen, anything U.S. add well don't very it you it have quarter, going

Daveen Chopra

physicians, obviously, but time so majority we're to exposure revenue, of positive they Yes, gotten I say, and in our and and with in We've launch love great would to far excellent technology. Europe's from mode the in technology. feedback safety They we're first also the Precision. grow, PASCAL been new Europe center, this see to the for the efficacy we're really U.S. continuing continuing and physicians new training giving open obviously

Larry Biegelsen

One mixed love reaction the to completed enrollment, your from TRISCEND The helpful. just I'd of you're confident reasonable how some you've you'll are questions. going you see profile? expect seem an be trial for Thank the sorry. I'm TR then with pivotal EVOQUE TRILUMINATE. and the the the such reaction better data guys, replacement, That's And would put for but II, terms to safety outcomes you to hospitalization as and on with just hear see what to mortality in follow-up you efficacy to improvement that in taking reduction, U.S. physicians.

Daveen Chopra

TR TR very is is Thanks sure. jump-in see excited safety see only kind And a of really that TR we Daveen studies randomized confirm a offers et it's tricuspid trial in TriCLASP EFS I treatment that think TRILUMINATE. data high-quality the the seen great previous that what tricuspid that in the little and actually of of cetera, see Honestly, thoughts CLASP reduction tier offers space for to see helps life. significant first controlled we've in PASCAL again. reduction the outcomes patients. good quality data like really Yes, TRILUMINATE, we but also meaningful bit to our time. and this Larry, We're for that significant not regurgitation on TRILUMINATE quality-of-life pleased show see for our tricuspid on study, we're I'll the

offers For maybe TR tricuspid this think help CLASP disease us, out I'll study we'll you of Obviously, toolbox ongoing, future that I and give is in that just II this data out there, also tricuspid offer great journey. impact lot a think figure potential and as of solutions. believe the and questions right the a need all on but also tier therapy. does you But replacement obviously, we a on figure only that the the will some also we tricuspid great more but for technologies solution, not that asked out you together comes tier

Larry Biegelsen

All right. Thanks for taking questions. the

Operator

comes Robbie Marcus Please Your your next question JPMorgan. state from with question.

Robbie Marcus

Okay. Thanks start, to said for minute trends the at and my taking a you as spend I'll add OUS, I was congratulations Maybe pent-up And and some want question. well. TAVR of on demand pricing to also Mike, U.S. it quarter, if then staffing continues around might like Ultra beginning improve little the benefit get help throughout sales SAPIEN And the the sounds you but on a year. the that RESILIA X world. to there

So love that trends do offer, you're there think or was diet thoughts you seeing, continue these to in just improve a can what are and a year? January throughout and accelerate bolus get on the your to

Michael Mussallem

this comments. to Robbie your thanks Larry appreciate on go Why and one? I Yes, we don't

Larry Wood

we we lot just Robbie. gradually rest mean, we I saw see that evidenced the I'd January as of year. I February going screening, much QX quarter, than I come see say, Yes, up it We've that's to throughout of we seen. improve that of less the we much pipeline the look staffing and historically the and saw and kind in continue think we're in but have thanks a to refilling was seasonality expect of a out I just we we expectations. pretty played with stronger results, and seasonality. January think holiday, If the at anticipated the our out March, improve, also in-line typically

were terms some hard think but of really, trying do January. certainly your in to do in that, it's judge to catch-up I'm So we us there backlog, not for

Robbie Marcus

for than Street and the stood year. the going one the the Scott, repeat yet How anything maybe we in margin cadence of first And quarter, that been the Thanks. in quarter reiterated came little you to Great. you, forward? in targets spending expecting about higher should for out think had you that OpEx the a won't

Scott Ullem

up in so quarter spending did had the higher we with end budgeted. than Yes, originally we first

rest sales the for SG&A the Our plans as unchanged. the percentage unchanged. And for for year of our spending full of R&D and for a really are year, guidance

first sales bit for In came little higher It's some we the by a We had quarter, several design. compensation. performance-based to in reasons. sensitive highly

the we'd so, to performing when is like people And well. reward topline

expenses We in U.S. as a little bit little also on. projects working result a income that some one-off had mix things, higher OUS. we're onetime had for We tax and came some rate of

some were things through you of those flow the that saw So QX. special in

Robbie Marcus

it. you. Appreciate Thank

Operator

your Kumar question. next Our Vijay Please question from comes Evercore. with state

Vijay Kumar

what that the about of that back can you quantify thanks my were? for QX versus And question rates prior and think from quarter mid-single part I improvement you're at the and a growth. here. me to add what it when good Hi well. congratulations wanted digits, catch-up on, question was underlying QX, exit perhaps about a progressed in on an was when the how double-digit Mike, perhaps thinking in you as my trends procedure double what I trends, look and talk procedure Can you improvement let to guys, TAVR, X% taking start or X% go congrats here

Michael Mussallem

Vijay. Yes, thanks for Larry. and I'll to it that, I give your appreciate comments,

Larry, gave you Although, add his shot, right? already anything I see think he have best if to to it but wanted

Larry Wood

where I for quarters think staffing real just capacity in I a plus that is encouraged a see the tried think took if patients. you'll know and and a after to I but TAVR in growth add don't getting so question, bottom up overall our know, I more to back I Yes. the we last really going couple we tough and we're trends double-digit to all our from of I just the think you system back of have by that reflect we're lot this the and guidance, think highlights of that's note range

Vijay Kumar

this Larry. I'll different to try way, ask Maybe a

second quarter price? TAVR? of if see the volume what this XX% SAVR, that is continuing why faster And pin Shouldn't straight XX%, to than thoughts any TVAR. outgrowing is Is you can down. be this on versus do is percentage is SAVR we TAVR SAVR that The growing what outgrow SAVR? have Let's is

Larry Wood

well growth the Yes, saw very by that in surgical excited we're all, think we QX. I of first mean, I

I think we high, reached seen an probably probably at haven't long-time. a all-time in that we

certainly that's think of has innovation been a I premium really we've part and so reflection investments this what over several the competitive happened the the at that similar that the to of TAVR. and years, think position on products helps we see and we from I think and last procedure made did the we adoption saw of we our our I in premium the the same capacity, get time growth that results

surgical competitive on a bit of then do market but price we from probably as the and get as the capacity our in that saw improvements of business growth side little to some the of products our position the in We well, premium well. addition

than surgical are the So on the there's on probably drivers more side side. there TAVR

Vijay Kumar

Sorry, can price volume whether Larry, price, comment TAVR? majority this was growth you versus on volume of versus

Larry Wood

key volume mean, contributor that. question a there's was and I no to certainly it about

So to contributing the there things three are the that's surgical that it's whereas business, units. TAVR thing, yes again on much pretty big primarily are but growth a

Vijay Kumar

congrats again. Fantastic. Thanks and guys

Operator

Wuensch Joanne from Citibank. question Our question. next comes Please your state with

Joanne Wuensch

your of quarter want just a just tough in and bit on and overhang, evening, China, missed, now had be Mike, Japan, and run-rate with the of but nice I what's will to right do little region? beginning quarter four. spend and in quarter Japan Good your if time you like down the you there happening what particularly looking to a COVID XXnd is

Michael Mussallem

do take and Joanne, appreciate at shot Bernard, you your a comments. to thanks, that? I kind want Yes,

Bernard Zovighian

so When has it headwinds. XXXX. Japan is diminish course by of going impacted COVID over the Yes, and largely still to been we believe

some our We here. Japan, starting from see are Ultra reaction latest customers our bringing technology are RESILIA positive and we in SX to also

the So are together for latest bringing from and we very COVID recovery hopeful the our technologies, us year. with

Michael Mussallem

during add, product years, still of Joanne I is the we this thing Yes, for is the China launch is but on TAVR the from to going small RESILIA us. Japan COVID year. Ultra launched can other that. also benefit Remember front relatively the the

we goes just And last, for year as so, think that's launched month. And here lift be this on. going that's the this a Japan to

Joanne Wuensch

Thank you very much.

Operator

Thank you.

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

Travis Steed

Hey, well. in don't Couple next just normalized grew thanks lot you'll I and did if as here, the of But know, guess I first you just the could Mike double-digits, you a January. January U.S. if the then congrats questions QX? you still be normalize say, question expect is of how just and U.S. growth QX about TAVR? to total both color to from QX think here, like step-up TAVR real TAVR, sales on the how much what or worldwide or should for a QX - we any expect in in rates

Michael Mussallem

Okay. Thanks, I appreciate that. Travis.

get we your growth, I sure it right? so repeat QX make you could the question So, about

Travis Steed

January normalize double-digits did course, you the January, catch-up if looks you the U.S. TAVR it's so normal of or high single-digits? grow if January Yes, more will, still

Michael Mussallem

January strongest typically much Well extremism, where see expand, see fairly month no January to in by our again, quarter. just as worst was month. our means of the pretty try we to just extreme didn't seasonality but We it's

just see with a to gives strongest and more continue We pretty February quarter, was hope it I stronger, a our it in was like much ramp March context. month, wasn't were that in-line but expectations, January so it's our but

range, up had staffing that be we the think And felt our took we guidance of now we what bottom to I in expectations into because in and build it's to XX% we're strong XX% we've gradual improvement what is kind think our globally. to QX, seeing but tried a our range the I is in of

Scott Ullem

that, we single probably pretty like point double-digits, were trying quarter. month the add the around almost X% $XX just to Travis, growth. was was $X.XX We I'll normalize January, billion. and of Scott. low of we're this if but million, isolate we that beat it's Yes something were midpoint to Surgical, so for was our every at so to to that rounded by QX That the that, getting precise at half guidance

Travis Steed

and into the then Yes, on at in competitive you're would that's about launches next where as the I thinking U.S.? helpful, there. RESILIA terms the you penetration you're move in question of of be rollout, some in how guess And the XXXX,

Michael Mussallem

very we're pleased in Yes, in is now and surgeons. INSPIRIS and of become really on has which with on how the rollout MITRIS surgical SX footsteps on the We're RESILIA, with has extremely UR following franchise, our popular gone.

And the be And the get that UR. going to And impact that's by Europe. started leading U.S. both seen for so, we platform end SX our in positive to they've legacy follow the really expect year really we've that and of we from us. the

And list with that which remember with to just shows think we positions we've value so that the that far to that's price for easy increase I RESILIA and platform. do brings the how respect gone appreciate pleased went that never and pretty been is and a

how it it roll expect we're with leading the has the rest to-date. do launch out So to very encouraged continue to but we of through our the gone year, We'll platform. be

on is think follow-up I had you correct? competitive that launches, a question

Travis Steed

correct, That's yes.

Michael Mussallem

all on around market the command been outside that's time, I one out of complement number look launches at of two, been products of Europe, mean, we if for about probably stable. long there's fairly a whole XX% competitors have of and number going and the a And competitive there.

more it's our out I about us it anything else. to rolling platforms continuing innovate about is it's for So think us than and leading

Travis Steed

a better quarter. Okay. Great and on congrats

Operator

your comes Please question UBS. with question. Danielle Our next Antalffy from state

Danielle Antalffy

a patients' TAVR definitely for an such much with with everyone. But for will Mike, for so here. of end the my era the sound broken share the it's afternoon, that meaningful you. been you And like record be missed, on on and Thanks over pleasure journey taking question so question. the thanks as a many it's we good a us Hey, being you first on this growth impact so guess letting And guidance I such is have lives, you year? and

if comp guys a perspective, is And look I constant XX% you up comp, currency a you at put growth. mean from QX tough

consider you on there backlog I had print, comps relates get So question of through worked I as TAVR little not it more my we given down but QX to the is aggressive sort a guess why that moving the as easier guess move strong quarters, to some bit is actually the guidance the growth anything year. January, through in

if just one have I comment quick could and follow-up? on that So wondering you then

Michael Mussallem

nice this go to comments, turn your don't thanks Yes, Scott for question. much Why for a it has to been your Danielle, I me. over so through pleasure

Scott Ullem

Yes, I range. mean bottom did the we answer is, short the increase so of our

XX% rest but So it move, does we're January expecting on still to and positive not huge not X% we XX%, indicate a nice a it's had of the that XX%, we're think the range start right the this it's us this that that At to for We tinkering year. more modeling premature TAVR. than in is to guidance. with XX% XX% for point, assumption any to

Danielle Antalffy

after Okay. first That's And guys fair. I quarter. don't release you tend aggressively historically, guidance the very to think

I so quick very U.S. market I know it things, seeing recover, early? that's fair. side And on as know how on again, seeing TMTT So you early you're question launching, that of relates are just it's market - in what guys growth for but Bernard to there the the much PASCAL you're curious and

just So, say, entry not so could going-forward usually to we're growth in markets but comes if there? market signs look you getting can what Thanks a wondering and much. market like net any tax, accelerate on but sure what second

Bernard Zovighian

question, it's QX. we know Yes fair a I about the are pleased indeed,

we We share that U.S., and we have in remember not market think are about is growing was mitral expected we the the as was QX saw growing recovering. sure are, the during some COVID that But the leader, again signs I'm market you again. the correct. not if you seen positive market

is look benefit. seal a pleased introduction about market, we of well very the of very to the see recovering we sign So, we PASCAL our Precision, reacting are our technologies, it the customers and differentiated of that good at a

good the here in need. we feel you. impacts this have we So, can to about many patient Thank

Danielle Antalffy

Thank you.

Operator

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

Richard Newitter

thanks taking questions. Hi, the for

it's said whole I getting there. up getting entire So just of in I staffing. catch worked just up guess, and know about me talked you worked to phrase? kind two the I referrals the the from to the we've first, hospital diagnosed to know Is patient past a that the for the everything all patient

- to referring So year, improving? with for we last saw staffing improvement specifically hospital to you kind are is just to of from a what get the late sense respect when you say that trying

second of which Thanks. installed the just past level across more installed-base you think or characterize it comments and this recovering kind and the the of just at at centers - entire where point? kind I a to recovery question are types of across kind implanting can varied rates uniform was about what And of or very of your as in base. on that you the talked Any provide

Michael Mussallem

first because take I'll question to I'll second first, maybe and take might couple a of your answer Yes, question. start, your it

the this think trend saw and that we by more centers throughout during centers being driven smaller seen larger we've this of than is think a COVID. sort I growth quarter I

seen when seen the closer people we've to we've stay centers. COVID home, I smaller probably has growth more in think spiked,

further see traveling, larger centers. And wanes, going people bit little as and COVID we a to maybe

with over and And this trends year we've a last so. the think so, half consistent seen I or is

talk talking TAVR about our talking staffing, you're nurses terms OR business. post-care of sort ICU primarily it in the and about it's our you're the initiative. surgical of, we When about In when staff depends surgical when business business,

When you're it, into workout. because talking more a a TAVR, lot lot upfront that goes more there's about there's

and CT after-care sort staffing much side. lab for for and cath of the on so it it So and the don't requires angio improvements need we broader

get trying So and just this in. get to have than - now, working trained a and think I been better for people seen, year generally, we've think at I probably hospitals people

our generally day-one. hire I just to through say, would saw speaking, I we hospital, in and from at and person a process think surgical. get you look and say, we I it can don't with effective remember, broad saw with have performance. staffing the but and that's and we that quarter They - saw in certainly certainly better our Well, TAVR, then you reflected a training they're go

we're ask I'll And hospitals to what needs to comment Daveen maybe to saw. improve at it year. this not continue to It's side the the rest hard yet. continue I work think done of like he over But TMTT on the

Daveen Chopra

Yes mean. I

we're But of pathway that go parts lot to continue a I we the think you that differences where into kind probably steps different not of similar people, lot of And a TMTT case. a there's comment there, made again, a all those a little here. in are bit continuing minority as a patient get different player said, still staffing. be fall optimistic Bernard of to better that the it's

Operator

you. Thank

Barclays. Our with your next question your line yourself. Miksic Matt Miksic, Matt from Please un-mute open. Please comes is go ahead state question.

Matt Miksic

Thanks so Thanks much. me in. fitting Hi. for

gave couple the that the on TAVR kind by platform, of I of on appreciate a of TAVR understood price that of one target so to on I of just RESILIA, the this little know your generations correctly. maintaining the here, just color products, end broadly, if you've follow-ups the I year policy kind up a that - So moved majority revenues you sort of set quick of unusual? even the you as getting U.S. of the that to had across is a bit and of But platform it

a way U.S, like Most devices referring you're DRG's whatever it non-teaching in hospitals the and it this having portfolio or in if urban to do particularly however a and than the premium, standard sort contract here different call work New hospitals adjustments SX hospitals companies the in in wondering RESILIA make to or at across just portfolio? York. get given payments - different rebate having of and hospitals in med pricing I'm to tend

$XX,XXX or to way follow-up? that given have just your costs the I to, have afford for then round to to joining be be able the for some a when do the paying one any the might of of thought to giving it's of thoughts staffing on $XX,XXX especially Love get and gone up. group help reached centers sort TAVR to you're given smaller of sort have If quick maybe rest

Michael Mussallem

to pricing really really that We did our out price launch. but we've a we haven't philosophy. and increase Well, gone time This the through partners try with be the increase. list first price that's increase, do price hospitals, Sure. our since we've is we good changed first rolled take a

so, we've other that based And on is, done always volume. always rebated the thing we've

So large you volume discounted obviously out. centers, get

And across treat standardized fairly volume to a philosophy to to try the that's recognize philosophy. But and changing we price, that by do that's we that. country our the try performance see tried everybody different their way that don't I on based us we been throughout. centers having

is look all our to if majority we bring be And thing with Europe cases when have U.S. that efficient, more benchmark other in with of just I supporting mortality hospitals produced all partner at worked program and well in in done. to Japan in. virtually do we lot do value. the and that's but and and data some people things at help almost think still to things it, procedure cost-effective the other like hospitals is us trials, at that's run that you try a try cases of really of work and the you benefits every our sort that's the of with the unprecedented them for model and it's the We this have for case look an clinical the our virtually we look incredibly been you and

that we for are fair feel creation more the we value the prices have. have we So that than

Matt Miksic

of behind and broader given to of these facilitate the ease on specialized that one sort some That's facilitating to thoughts the done and active bit, and starts Any them? staffing staffing same sort and pressure partnering of help fair. the And -- staffing staffing imaging those the has can lines around tier specialized have then sort mitral I for procedures, procedures. that's been a points more extensive guess see does, anything of you procedures little additional sort needs along of as through with yourself centers hospitals, adoption of utilization required pressure of doing

Daveen Chopra

all treated the get think top-notch well patients TAVR cetera. like but has, start we to et these teams creating start and more efficiently hard infancy, training, Larry of effectively bit partner. think And it's same I being training try We're the really board. to cetera kind to mean, working kind Just to in to Benchmark I are in patients always of on over tier that part it, we Daveen. and excellent is want long-term. recovery going mean, et more side we're our we are to obviously going getting them cost-effective more look programs this how to as try together I a getting obviously, we of early to And through the process, partner we about help in I tried manner. we days, that's in detailed of a little our scale kind as Yes, look to since the the hospitals, the across a don't provide with to think those great we program, a help as have it together the

Matt Miksic

so you behold I culture, have something been the to company. accomplishments missed. the That's it's of Congrats, and much. be Mike, Thanks And will say the to fair.

Michael Mussallem

Thank you, Matt.

Operator

next Stanley. with Our question comes Furlong Morgan state your from Cecilia Please question.

Cecilia Furlong

wanted to Good afternoon you versus out the questions. called for trialing, the comments that competitive taking and market thank just some there return the Japan, understanding to Edwards you. you I how you growth around would of frame

in at guidance the in as And Japan looking-forward well then point recovery RESILIA region. recovery reflected we're So really rollout? this seeing to Ultra what's from as

Michael Mussallem

to Mike sure on that Cecilia, little the again, of first can I here, understand part I it. make bit that question this you want just a zero-in is

Cecilia Furlong

a You were seeing talked I region, the believe. about dynamics you in bit competitive

So more if versus curious a little could you on just how that impacted market detail just provide growth your growth?

Michael Mussallem

Japan, in other had so two both competitors new Yes, rolled-out we products.

usually being because is our biggest we're our in and and trying not launch it's and how SX transient. Japan new think those ends products this that that we benefits and when we've I since excited so, features done UR. work launch, that uncommon what up the history, are And largely and getting physicians which initial our just they seen see understanding to rollout products we've And we're throughout

excited And we're about that. so,

COVID guidance uptake, better in looking-forward quarter, during what's continued big broader our the throughout recovery, guidance. COVID QX the broader in recovery COVID a and for pretty and the a it improve still on got that's continue expecting but we're and think Japan for what's to looking we're to was I in is we're broader year

Larry Wood

down of been COVID to only half is really then last slowed second the pretty it last the over hit for thing add a I'd us of grower couple the Japan years when has year. Yes, strong and in

waning with the starting make QX in the So, that launch and we're a forward. Ultra difference the launch of SAPIEN here, really COVID looking-forward it's to going especially -- with of RESILIA and moving

Operator

it for And Thank one time state question question final we to you. some question. have Please Jennings with your turning management and comes for Cowen. remarks. Josh from that gentlemen, before over closing And TD ladies

Joshua Jennings

we of good questions -- you all cycle. for calls more the Hi, in if of should on that we Mike, market Thanks And as the and questions. wondering when guys just but TAVR I'm that growth? to taking wanted XXXX market get question. for these the TAVR the meaningfully contributing and have I evening. them. to and we're replacement the really earnings out on forecasted, start TAVR XX half getting billion for just and bigger, Thanks the piece appreciate currently you been about on have market up mean to represents question taking size to think in insights your you But could percentage more really, TAVR Larry, it TAVR TAVR imagine $XX meaningful becomes a

Larry Wood

enabled I with valves, can know tissue and the was I TAVR, more that think no, do quantify it TAVR for get for gotten but Yes, of opportunity I development to patients today, SAVR and have but TAVR tissue patients TAVR a don't we things for you the it's question. valves. but do we good that also one that its

our road. let valves younger the patients down on of a option them and is for patients that payout tissue now their now because catheter-based business, Surgical valves side get there the physicians can even So

the it but start that at be that is time will continue part. grow starting So certainly, time, that and customer will you TAVR grows valves as period age will to become just and TAVR TAVR to to bigger which SAVR reaching in in probably that through that now get a TAVR more meaningful, XXXX. to be discussed, we are certainly will the and something look

Joshua Jennings

Appreciate it.

Michael Mussallem

this I'll closing Mike, Okay. some Well, comments. is make

Lifesciences really and made warm for to years. privilege to immense our for thank XX It's more honor advancing lead and And you at care millions contributions of First much team thank who the patients remarks. of a Edwards so many your special want I to world. our than all, around helping have of been employees a

culture excellence. proud of particularly our and our to innovation patients-first and commitment I'm

Directors. I to really be well-positioned is role worldwide. with I and future. talented my to Edwards our a truly passionate to leadership the transition employees honor believe for brighter an and been executive success Our team new And supporting greatest Board my as CEO, Edwards are the look I of even forward to testament and we It's

So thanks the questions the Edwards will additional call. for your continued in team welcome a and lot after interest any

Operator

disconnect. with Thank All that conclude Have evening. may And conference. great a you. we today's parties

Edwards Lifesciences (EW) 26 Apr 232023 Q1 Earnings call transcript