EW - Earnings call transcript Q3 2020 | Edwards Lifesciences Corporation

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Operator

Thank you. Greetings, ladies and gentlemen and welcome to the Edwards Lifesciences Third Quarter 2020 Results Call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Mark Wilterding, President of Investor Relations. Thank you.

begin. may You

Mark Wilterding

Officer. afternoon, With Good Chairman thank for Chief you Chief Thanks, on everyone today’s us. Financial Ullem, Scott me Officer Mussallem, call joining Executive Diego. and and are and Mike

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

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

Additionally, risks and could but and with to those these including, the release, important factors could statements of to, on differ cause XX-K COVID-XX found product maybe the that XXXX website at filings, in company’s Form results the safety Report Annual actual which on that and press cause SEC information differences other involve Information not associated concerning pandemic available limited Edwards’ our materially. all are uncertainties, edwards.com.

call his adjusted, to today’s call terms non-GAAP that, Otherwise, and and results. like to the turn Finally, during between they GAAP Mike? using in to press I management Mike referring over mentioned a referring Reconciliations to numbers included With quick that reminder for the financial would the are comments. underlying is release. non-GAAP measures. when are GAAP

Mike Mussallem

Mark. you, Thank

and Let way period. they me during that to the team of am passionate this by serve difficult proud patients begin continue very our I saying

and that delivered on team has has clinicians dedicated our count to Edwards. support chain the field supply Our continued

with expected around strength growing reflecting TAVR at future than also of Connect on pandemic. the announced world. the to third across $XXX X% challenges the platform new in Conference quarter to adoption having pleased diagnosed quarter global with we be compelling In COVID the growth were results data report procedure of and quarter, geographies up the We treated. newly report are X%. notable our system growth In will better Globally, our we investments Global continued million, patients clinical average care. ongoing recent the our price and selling increased TCT all in by headlined Growth TAVR, a in third meaningful are pleased Sales and that entered SAPIEN volumes step-up a sales therapy therapies third billion were Europe. of stable. despite adoption impact as was sales led $X.X valve patient remains

sad elective increased suggest away. replacement Sinai we progressive scheduled treatment demonstrated with to patients screening patients of results There passed by first Although XX% patients required there AS XX% with difficult third TAVR that procedures XX% procedures are X that for disease. being back, Hospital the risk heart study, quarter all. in backlog time the of is of focus And during the worsening treated waiting Swiss pandemic halted aortic affected reported of month who for the of Mount postponing of same an passed of Taking study structural the significant lifted on a know has conducted Defer weigh a failure. after particularly At of or were or A treatment no heart last forward they in the reported closer aortic going however, was a system. were remains the home, Europe, know significant valve required that previous against patients not continues heart of in that treatment Evidence those we After urgent as second consequence continue many believe the valve rates that somewhat we inevitably intervention valve and consequences. adverse mortality. delaying aortic growing replacement, in patients step stenosis the severe postponement valve that [ph] COVID a hospital at has to by heart like on valve this by COVID. months, effects month the disease the of are we that been delayed to with for the and away quarter, elective recent replacement intense delaying ban urgent nearly that the or treatment a recognition to symptoms time to patients AS program patients related very structural due serve events

treat TAVR safely need Our patients strong time for that that in patients. determined hospitals same have the at their observations COVID In indicate conclusion, most and evidence they whose care of indicates is AS can resources globally efficient heart It can outcomes. structural that hospital is and excellent disease benefit and under-treated deadly proven with offers many use today. therapy a more patients

with U.S., approximately our back Now, QX. increased by encouraged QX, last XX XX% versus volumes the in in very the XX% the range sales TAVR active by all despite growth from approximately mid year, third were performing up year improvement We cases, turning in in quarter, the in TAVR TAVR of our to XXX% single-digit across procedure region states, period. ago results in the sites

Two-thirds in have physician completed broader U.S. a of feedback high ease-of-use Third and U.S. sales year-over-year. outstanding. smaller the to aortic across U.S. stenosis population increased TAVR our centers on in quarter remains centers, of training are growth quarter, SAPIEN underlying paravalvular improved which of Ultra range third the centers and with performance the X in proctoring leak and the single-digit the our Outside TAVR patients. more highest XXX than in access providing was

where due patients was we in growth double-digit faster to and than adoption aortic TAVR completed of in dynamics every will commercially our stenosis, In global China, belief Global China, by versus when the are Europe, projection under-treated. our received through X%. Yet treating in summary, across in our prior normal to in TAVR our comprehensive take TAVR recently and where decade $X growth and – of cases country driven regions will to this the X be immensely the we plus we in from our we increases and Outside Europe. platform and in over to quarterly year-over-year proven strong continues the market be be versus X. minus to growth first a underlying QX lower growth AS Growth Edwards’ to pandemic. strong X% nearly performance, on Europe, in training was look to single-digit encouraged stenosis adoption We in most QX Ultra strong therapy. with and for more sales Europe of expected. partnering continue to remains based to the international We be And available our a growth anticipate In range. expand high strong TAVR, in with was we continues TAVR by remain to of growth to of XXXX anticipate higher been significantly hospitals although as forward regional we year regulatory therapy an Sales opportunity likely adoption return growth country particularly billion suffering the third continue have SAPIEN year-to-date previous TAVR QX plus continued saw TAVR the severe quarter. at for anticipate reinforces XXXX. We expect focused the in presence across aortic it the Japan severe. valves see XXXX was and our SAPIEN successfully in a will growth be U.S. other by increasing continuing rates program. transcatheter be Edwards of QX although COVID high-end to variability under-treated by to begin we high-risk availability unit disease the on approvals impact significant our of range driven Europe, time introduce

as to drive opportunity growth. unmet therapies the to significant transcatheter we and Turning to substantial potential this patient mitral needs TMTT, continue or and tricuspid with one view

Our focus will drivers, three advancement of value a success, real our therapies, which of be approvals indicators from adoption. leading of which world results key and on portfolio and favorable will pivotal the favorable we the ultimately support trials, outcomes believe differentiated are clinical rigorous

EVOQUE to designed with our of we we of mitral patients to and differentiated valve therapies, received of profile. ACE for It CE began introducing pivotal PASCAL platforms SAPIEN and example differentiated and the to repair. continue In and As for mitral MX MX PASCAL U.S. initiate further both ACE the implant options advance SAPIEN tricuspid Mark to treatment the track features on mitral narrower has year. provide end optimize the before for the is system PASCAL recently PASCAL transfemoral complement trial we and replacement, a tricuspid with an regurgitation. remain and

end. we experience pivotal to by gained and initiate are track EVOQUE with In our our on encouraged year in are addition, tricuspid, by trial early study the feasibility

in PASCAL are with Class U.S. experience, to degenerative with patients In We the low favorable Conference. at mitral success XD including and reported our in roll-in XX-day study. pleased TCT reduction programs data showed pivotal centers system of improvements significant as prior complication We outcomes quality recent clinical from demonstrate regurgitation Connect the these life. presented valves, in the rates, no

MR X-year Mark class Our repair micro robust PASCAL for data and sustained demonstrated CE reduction.

and addition, we pivotal And In results progress demonstrated Cardioband favorable are making demonstrated positive follow-up TMTT results. five on tricuspid XX-day tricuspid studies. PASCAL repair X-year importantly,

enrolling be of generating rates we for pivotal each therapies. patients demonstrating pre-COVID clinical across body trial to could of a excellent are clinical While now couple outcomes results one forward of evidence a by quarters, at delayed our looking and portfolio our initial

Third million. quarter $XX were global sales

increase able situation remains fluid, new the Europe resume in are we and centers of commercial activation to procedures. Although

procedural We In PASCAL summary, we versus patient million. expect of in subject physician previous $XX continue million Europe. commercialization and million anticipate of and around in and continue of in to to estimate to be COVID We to TMTT interruptions on $XX advance focused our training, $XX success centers remain Europe our XXXX sales to activation procedures outcomes. of

double in while forecasting the In process, TMTT our XXXX to addition, sales XXXX. early aspiration in still is XXXX

In to many $X in are TMTT We need. that decreasing significant underlying opportunity a expect passionate Structural solutions $XXX in levels, of XXXX similar million X% believe this of the XXXX. market long-term an to opportunity continue about reiterate the portfolio to our Heart, the a and global confidence remains on sales now billion for basis. patients We bringing Surgical quarter by and were third

including demand recently Ongoing among and the flow. grew conduit care becoming willing tissue that INSPIRIS U.S. valve we of third contributed aortic in many and In quarter, KONECT valves, manage active of patient Edwards’ the observed rebounding by in also third heart launched valve steady driven were all heart and to increased in surgery the hospitals aortic by surgical volumes. in patients geographies the hospitals quarter, the regions, During able surgery around RESILIA standard encouraged INSPIRIS the valve INSPIRIS very utilization patients. premium to surgical We more prioritization many is to of world. more valve the case surgical adoption seek younger more valve the remain

is centers in both add Europe and in centers. the and to our continue existing adoption new INSPIRIS U.S. We growing

this and continue robust in training commercial repair mitral first intensive valve system. beating of data the new we on in QX Europe, Following to cases for physician HARPOON collection focus heart

decline We to faster and full procedure headwinds Surgical therapy. may surgery expect Heart patient X% minimally growth. In recovery Localized year we continue the results sales be times to COVID-XX with invasive XX% to seeing Structural in positive for this to range will XXXX. from continue are with XXXX initial summary, hotspots

the positive by remains technologies. However, our to our newest our will in that expectation market adoption return sales of QX, growth driven

ago were for used products by extend We technologies. TruWave to ICU but impact provide about Europe Care, COVID-driven capacity million the expansion. ability of a more premium offset were ICU Surgical Demand one-time are Heart cardiac global our elective lifted period. associated was in for In patients sales quarter was in the line Sales excited year of surgical pressure the our delayed options large in by the devices for disposable monitoring with Critical procedures. Structural treatment $XXX used with surgeries order our our innovative and leadership in solid, in

in be in will spending COVID. sales decline limit will to the anticipated Critical negative over a the due However, we in their which to to XXXX as continue reduced minus anticipate U.S., X% I spending U.S. experience for continue plus HemoSphere capital In we is a as range Care And our Scott. to now, continue result turn orders the to summary, to within guidance hospitals X%. largely original that call capital still of of

Scott Ullem

Thanks additional a with rest third lot, perspective the Mike. of Today, how I we along quarter, anticipate the unfold. will year on the provide may

third underlying the geographies, also primarily X% as we expected performance, expected across we product sales in spending. constrained lines quarter Earnings was our all than growth were Our especially driven than Europe. with by combined performed line better and our the well we top stronger

did was X% I implemented share, increase and $X.XX share to strategy. us our at adjusted previously XXXX. investments earnings the take supporting profit $X.XX. our have quarter have any per earnings a cost during we As COVID, of higher GAAP actions reduce third long-term allowed to operating not significantly per $X.XX, mentioned, over a in intentionally deliver margin we strong measures employees control This impact but or

third For including offset This prior general This sales XX.X% Selling, increased personnel-related gross by of negative COVID was margin million expanding by compared structural the driven responding administrative field from from included to in expenses, field associated improved with from million TMTT offset COVID. partially and the level incremental reduced manufacturing and spending $XXX the heart in quarter quarter. efficiencies. XX.X% of expenses or was resulting impact Europe were prior organization year. transcatheter in spending a in exchange down the $XXX consistent to year and cost adjusted by quarter, XX.X%, our third decrease the foreign

reduce Research mentioned trials As we strategy. initiate impact did XX.X% to of plans nor the reduced from in sales earlier, TAVR prior and our investments in any clinical transcatheter or consistent to long-term lower were the by clinical compared costs partially valve million, third expenses to significantly $XXX our million replacement actions spending not mitral level offset investment development included employees year. supporting I This and increased in COVID. spending trial $XXX resulting quarter of

Turning favorable XX.X%, rate tax or items. special stock-based taxes, to basis benefit impact was or included was from reported points our accounting for of $X.XX to basis compensation, this our the XXX employee rate XX.X% which quarter the excluding a XXX point This expectations.

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

the year have or now expect XXXX rates XXXX. exchange quarter third compared At million Foreign prior full rates, XX to year. points increased $X sales sales impact current by growth neutral we to versus to a basis FX

quarter Our compared year. previous points earnings rates $X.XX. by per our rates July estimated guidance – impact. margin FX gross lifted million basis our a negative Relative FX profit XXX $XX the prior negatively share impacted earnings by to to our third guidance, by

sheet, a end balance have $X.X Turning quarter. the to with cash at investments approximately the balance and we sheet the in of billion strong

we of credit addition, an $X to In have undrawn line billion. up

shares the outstanding expect outstanding during year for full $XXX approximately and of level. the shares Average bonds was quarter activities million defined the split. $XXX remain from outstanding shares at stock June $XXX this $XXX flow were for Recall XXXX. $XXX spending number of we million, in public operating mature million, third by executing Our a capital of the that quarter we less Free million of average X-for-X don’t million. until cash as increased third cash to flow

payment related last negatively $XXX million. to million by $XXX of property a the year-to-date Our quarter. was settlement flow Free is cash matter impacted cash intellectual flow free the

XXXX Now, I year. the will remainder the finish guidance of up with our for

that regional is the although for to the – the foreseeable and Edwards hotspots future. of financial behind us of Our the we guidance assumes XX anticipate COVID worst impact risks

product Within achieve to the we year-over-year sales our fourth TMTT sales expect anticipate quarter underlying $XX similar now we we growth around of will quarter. third million. groups, Given that,

to TAVR previous and to minus estimate still surgical plus X% Critical minus to range minus X% versus of be XXXX, of continue minus be high-end previous We at range growth growth previous growth within negative to our still plus X% X%, but to the our our of XX% for to within of guidance X% guidance XXXX. range Care

now range that, bottom we to of share And per share $X.XX adjusted We $X.XX fourth earnings are full for the Mike. per and estimate And earnings over to back I turn will be year raising end guidance $X.XX. adjusted with between it the quarter, our of to $X.XX.

Mike Mussallem

has than by behalf that Putting healthcare first of want it maintaining patients I and the delivering more our it With together agility, innovations critical the of Scott. am of Mark. for about around I I the is member important even never and Thanks, future I world. our to partners gratified infrastructure dedicated been to with that, over community, I team patients important saying is the we Edwards and conclude employees And on admire to the and work optimistic passion turn back more global extraordinary their am a in patients. today. partners and as resourcefulness of stand will

Mark Wilterding

Mike. you, Thank

to open Thursday, it am great on anticipate a format for we you like. really will Before event I December I We up virtual announce new in questions, XX. our conference will held XXXX be hope investor that pleased a that

updates With participation, the number this to event ahead. order market longer information that will take allow questions. broad ready our for available on In weeks technologies, we the we outlook include are follow-up. questions be for usual, More you on our upcoming one of As potential latest views and the website. to will on to ask please plus that, limit our one in term year

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

Operator

Instructions] Lewis Stanley. question your [Operator state Please with Morgan from David Our you. comes Thank question. first

David Lewis

Good afternoon.

for taking you for them. of couple me a thank and Just questions

in fourth improvement to rate, the crystal Analyst flu a we we and probably out to have limited quarter I you? the take So just fourth adjusting some for guidance improvement lower did or we what it makes commentary raising TAVR be very sort parse But clear quarter sense. at Do I it’s want that guidance no mean heading what here, means. it in but on know just to more of TAVR Day sequentially risk see resurgence of potential is are to

Mike Mussallem

Yes. David. Thanks,

are said a growth similar which our So, thought And the fourth quarter. remarkable in pretty this be of real testament is considered the it’s team third a that. sales guidance. QX when and grew we all our set we There in we we think like we a quarter environment to factors and chain. that, the that We would supply bit little X% to that three

One of will them XX% year, remember growth to all as and company, XX% in we related U.S. you even last more to what TAVR we QX of ‘XX did the grew in a have total

because is, QX a thoughtful probably So any a of by be higher of We other be in with an a repeated in that. associated sales don’t our than we Europe COVID-XX And factor of to QX at of so just in is much I a be lift, quite stage little think prudent in number going longer, of that related the probably persistence matter with associated bit the mention to fact then there not and it’s difference, of this a sales QX. it’s thinking which number the I one comparison, There U.S. gave significant certainly lift in the and is will think issue absolute somewhat Europe. us backlog QX. the to in the is uncertainty believe that

David Lewis

you the Mike improvement September, in improvement seeing some in are are TAVR into business you underlying seeing in But that U.S.? October and Okay.

Mike Mussallem

you growing to So, get that months, we into we to specific were curve have remember are steep not David, the going at. but just yes,

additional growth will of – think treated we are each when how So, rate many remain being patients constant if month. the even

David Lewis

Yes.

totally comp And sequential I a queue. maybe jump clinical for just and will me one just issue, then back in So understand.

kind Just that general? kind if your and the the just Thanks XX% feel Medtronic may so and to that market and just think much. non-hemodynamic you study strategy they and patients clinicians in frankly, trial targets that represents of curious population on described endpoints, patient the available here of Head-to-Head that actually their on you Mike, announced, curious some favor SX population thoughts what hit impacts of

Mike Mussallem

Yes, thanks.

a to think certainly a I that fact testament it’s TAVR the is field competitive right.

Our When under-treated. important certainly on of what’s we a system. It’s the is think industry put new reflect just it, and most focus into is that. And is deadly our we us. bringing It’s TAVR competitive to patients we disease. this on so whole more disease

future, If has in factor. to you grown why that’s are the look Edwards why the we biggest at or going past grow the in

I supports a with extremely those. think clinical that that happy we high-quality of body and SAPIEN the evidence platform large Ultra just Xand there is are

not to make have we factor, one Head-to-Head So, the outcomes and decisions element. believe on on it clinicians might it, patient total a study that be based singular but one

David Lewis

so Thanks much.

Operator

Thank you.

state America. question. from Our comes Please next with question Bob Hopkins of Bank your

Bob Hopkins

Okay, great. Thank you afternoon. and good

quick question, two timeline things. TAVR a is One Just follow-up. timing second the is

comment update I PASCAL the the on U.S. any on to asymptomatic On wondering are you but on check? also if Mike, wanted trial timeline timelines just just for approval? side, was I can unchanged, those then and assume on the readout

Mike Mussallem

Yes. Yes, did enrollment other line of much Thanks impact trials. COVID-XX in with pace the Bob.

We about update QX to and or with the to not talk ask the enrollment to we compared providing we at for have have conference time that. you at investor pickup more encouraged we stay will but been this by QX, so an are really tuned in

Bob Hopkins

if taking that’s on comment guidance? helped just you. able on then was or that is you are flare-up possibility slowing taking sort consideration as give might currently QX now? into TAVR something wondering the just on of are to into quantify that reschedule going that if Is TAVR right the you Thank that curious you you also have And follow-up I you QX? could And are how much procedures Okay. COVID side, was I consideration,

Mike Mussallem

beginning how get backlog of on the was you much and wanted deeper question, there? question Yes, about the was that Bob, to me little part in a

Bob Hopkins

not Yes. a you may have In have QX, – do a, but you just….

Mike Mussallem

Yes. Well, so didn’t. we

with think part and the clearing we We think was biggest don’t like story so our backlog of there U.S. tend impact Europe saw the U.S. depending U.S. can and our a backlogs in QX. be hospitals we – QX So are much this those work to going big and the those of there backlogs not and just point in the feel there feel time, we occasionally down. like that on We did Europe performance. country saw significantly indeed different that business. run we We aren’t much by there at wasn’t carryover is to in contrast

I So, know if don’t clear. that’s

Bob Hopkins

Yes.

Mike Mussallem

have have that We pretty all which in all performing also screening U.S. the hospitals you our that much are hospitals cases means patients.

And point. so we are into a normal this little bit cadence more of at a

In it’s terms general of the COVID question, a concern. I think

trying and we point We just are not it’s the think signal the us an of that Europe, general U.S. watching a prudent something uncertainty. but in because are to careful we be to inflection that the that with for see we numbers concern

Bob Hopkins

much. Thanks enough. fair so Yes,

Operator

Thank you.

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

Joanne Wuensch

for taking much two. question. very I you the Thank have

from The your PASCAL the this where in that is, first second launch revenues of my you is coming can markets, XXXX? is China, outside then confidence core three at are focused of geographic Thank one And much reaching walk bridge reach on think has stage? and you. next on How question expansion? us I level doubling through that is of that and we TMTT been the to

Mike Mussallem

Yes. Joanne. Thanks,

As our XXXX. of kind for we planning early you are can imagine, process in

a when there our going to of and kind So, double. we we about aspiration are extending talk ourselves out feeling bit

like of year, likely in-depth we are together majority investor the get when So, are more probably those sales much that the be about But at to we will PASCAL. talk this have to conference. to

– PASCAL it’s but and we do We going to tricuspid. of not of MR will meaning are going patients that are be year, sites help have will patients, new the ACE that treatment us not be TR only addition doing will help and next to PASCAL necessarily we and that

combination to So, that is this double. us what’s have to leading aspiration

really multinational first time China, reasons, about first this, it’s just we is are the for work couple really we patients, I Chinese we our know sure really fair was we going term, a lot are right amount take significant that of maybe systems self-imposed, and excited There but that for about is time. up get committed in there great process completed on think related are don’t so question to company to our get coming a There pleased is physicians it China. there. that to a major is though well-trained a Even with of bureaucracy are milestone of a really time. results a make of, cases. every lot also We hurdles not carefully in the we some Your they is

So, it’s us time. it’s going to novel to therapy take a And us for new that’s bring China. to journey just frankly, a some

lot with So, we of don’t have experience a that.

Joanne Wuensch

Thank you much. very

Mike Mussallem

Sure.

Operator

you. Thank

Our next your question comes Jefferies. from Raj Denhoy question. with Please state

Raj Denhoy

I seeing of kind a really is not year a a good It whether is bolus quarter of going quarter. implies be kind just commentary to afternoon. are maybe to I around where point, of Europe this from into flat quarter back year? guess but you year, seeing And that of the relatively the back right, I recovery is and that previous guess TAVR more pullback last the here or you sort really or to are there for X% fourth anything I to sort know is am the I Hi, the the come there. for talking of the of that just into curious range. to hate of upper of kind about flattening I it guidance half the the appreciate X%, the the But this the end of

Mike Mussallem

when going XX% last really much rate growth Raj, you, able we you looking different globally. with at and am this Yes, that grew what’s fact TAVR of be I to to going year am I maintain than excited on our this about maybe business are the consider kind that and

top a As on better that. of are going then know lot gets And pandemic is and put it I it, was growth on. the than fact, that feel global it we I going proud I XX% mean, in to of that. rate the a I U.S., don’t matter pretty while a think of

reading the probably that there maybe signals I really say So I about way to feel didn’t it we feel is something about wrong. it. that think And I is the uncomfortable

Raj Denhoy

empty. definitely that’s No, half half clear. full, Yes, glass crystal not

So you it’s up is so good yield of pricing some crystal the clear. in your a results of what’s on at rate, where terms ended quarter there? And actually decent, ground in there, maybe just for happening a PASCAL that on starting Europe, strategy any to a premium you indication of is

Mike Mussallem

Yes.

is up. we So, in up a very during our those the situation because the come way our again, really And this centers pandemic would bit in continue having in what but PASCAL added results it’s the were touch with to with the quarter and fluid we we quarter. pleased models. new It’s ramping call we are challenging, pleased it’s little high implement we

are every working they time. make that and So, clinicians great each engaged in very hard get we sure to results involved case with

for The performs as So, the same level. about good as be have a superior think unchanged. important that’s have turned we but past, really do Obviously, out what’s up a strategy really much is was therapy need we talked back data, with premium, we a in to is to most the and us. pricing at we as that this our

Raj Denhoy

very you. it. good. Okay, Thank Appreciate

Mike Mussallem

Sure.

Operator

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

Robbie Marcus

to around get sure And will year. CAGR growth have Is question. everybody am It’s frame into this put expected you at numbers, I maybe growth. double-digit I Yes, I because way double-digit we help and variance that interpret comps thanks people for double-digit wide more the I year Analyst taking is the off next in you it, to a but of the imagine Day, sure easy would this this mean? XXXX How there am what any ask can perspective? growth this should

Mike Mussallem

everybody I have should have in Robbie, companies. about you I if growth, some could right, Edwards low one really impressive coming of dip as growth take remarkable other so I a pretty airline, imagine just are mean, as you that you is terrific bigger are base. many we No, the rates didn’t But think is things off

there to something tried growth, I still double-digit think can what color for it’s to that I related return to add So, relate the to If meaningful. is is quarters. I

then would be hitting more bit that like well taken. four growth the would ends that higher that steady point one hardest, so to but and rates hopefully to QX would much but are expect QX lower state for up comparable rates, was see a your little some unusual ones and providing growth And we quarters we COVID be probably is see which and when likely a in color,

Robbie Marcus

given That’s and really back TAVR space follow-up the restart still expect are the here trials with at clock it sounds helpful. a it should normal, degree trial can a most Appreciate some on up like it. And like fatigue talked trials for then quick are here? should recruiting, one structural doctors recently heart TCT that you a competitors more patients of levels we about or catching Thanks. pre-COVID expect maybe in we X-month that to and to your just smaller to continue was here, delay

Mike Mussallem

talking pre-COVID a about bit. continues a we When said where way. probably here it’s on is closer, hoping levels. some kind as think And question, aggressive the you and stick back neck TMTT we imagine, and but situation roll go stable to out that little short that getting we there it well And be this like little along enrollments, Yes, we are have it’s good might are we TAVR, to our of it’s be we pretty moving in a something did it, predictions Robbie. challenging, might trials, making of our pretty

Robbie Marcus

a Thanks Great. lot.

Mike Mussallem

Yes.

Operator

from comes Matt with Credit question next your Suisse. Please state Our Miksic question.

Matt Miksic

on for of have getting thanks Hi, process one patients TAVR maybe patients taking of center. in the the follow-up sort the for for pipeline sort I just these the of on and one environment question. more and

So, in off back? of And any I your faster you in these want the wondering, is of I in then find I is third pattern to here quarter. that performance the just lagging. just all centers Mike there U.S. small said where grew smaller that mentioned, centers you coming about remarks in think leading am or that you how follow-up. large QX that or centers regionally are of that kind a in on talk prepared they first of are can Is just the more constrained sort or color

Mike Mussallem

the some hit faster the – but which were in Matt, would Matt. grow quarters, are speculating being smaller metropolitan more tell what fair we centers just have the saw, to less up harder really that guidance the We centers be see centers to why that, make areas thanks make did to we that you more smaller larger can extent. we or behind for given big just don’t different it of the is but Yes, And than back to we that, we stories other past we trying that maybe in in very seem larger. by the COVID, we question, are hard up, terms have evidence in explained

Matt Miksic

the getting pace going for the described it that of up of of been is up the then centers at number in into of process, Is maybe And part at the to am that the biggest great. is the centers part cardiologists? to or of some challenges progress you follow-up on? set the the a patients you I ramping risks the you as seen of toughest recovering dip you and presented look biggest, data just the and assuming, made that on the look are greatest pandemic that, it or have coming it and of do patients just Echos sort the get around and It’s have turning on, think patients so being reasons coming diagnosed, and taking their Echo, of I out that’s see patients trying around? Where challenges in again their in is the

Mike Mussallem

conversation this know treat the want at of hit have TAVR all I patients now Okay. that out. issue, mark QX for a figured the think to really which COVID and that they was and that really believed same strongly don’t Matt. for Yes. they in that patients cases health they with hospitals, and heart the by reasons time. how that hospitals, large, and structural question Thanks, patients I miss When first the for I or is to our do to mean, big right

its to procedures, hospital doing in take the they U.S., did and generalities closed when important. for speak stop So, COVID, whole is just sort which screening. stopped the around biggest the hard of It’s prepared that’s not doing been world. doors they market, only But if we

so they same the process on, both procedures the turned back when screening on And got at and the this turned way. actual

in additional Now, have had I screening beyond past. don’t capacity know actually the what that they have they

So just normal they that been year. there were probably have are in the lost probably becomes but that in constraint, just of system because otherwise not away some would somewhat today, the passed patients a either that more sadly were or

Matt Miksic

for Thank color. you the

Operator

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

Danielle Antalffy

Hey, good for Thanks taking so afternoon, guys. much question. the

on you we how are centers a PASCAL see on the seeing to product their Just these question TAVR, adopting with little of lot could a device more sorry, I than mitral Are give curious, same I essentially Europe you and MitraClip? centers or market? PASCAL, one am are from am you a shelves, in if color are the on Mike, repair switching PASCAL of they – on bit with carry saw the

Mike Mussallem

a Yes, will I generalizing I good some it’s to know be probably question. extent. And

very think are are from in see that split I they us But switch one another, in PASCAL, say or see interested system people So more less wouldn’t dangerous. they that that’s we cases, invite many that completely to again in, learning. they all I already them we

the and work help of are procedures part them it. We through

Well, give As to the teachable? we Are really just of Are But that to of sell indicators the you TCT it’s important hyper portfolio quarter. else TMTT, clinical the clinical developing? just look think procedure? encouraging. at fast on on I really they we data. rigorous how reproducible? PASCAL world be your we they how you procedures? along? outcomes? leading of you therapies in about learnable, Are is for some leading I We they I think about, trials? incredible good doing about, real Are to three on they know of indicators Connect are for And we differentiated something How focused saw are that are going clinical those maybe much factors, this trials got most how think if Are think have coming and then provide really very those what’s going some

sales. to sales And so results although maximize those adoption, indicator so a put be an other get both sure things of to I track, more just that great interesting make it’s the to going and or these of we know that strong factors. than We one are are lead to frankly leading some energy approvals to the don’t trying

Danielle Antalffy

is trials guys the Got trial. And the could Smart it. on trials, Head-to-Head or then dynamic the something you in Thank physicians if helpful. the had at from Thanks. Medtronic this more to is curious detail this whole all one that That’s I counter if or you And if that that hemodynamic ask and am noise I just of and and gradient about? fields much. care more question, actual that Medtronic running so have is

Mike Mussallem

our folks but especially think just know I performance, a it, even X is the SAPIEN with that relied people not we X, really normally, know pleased about SAPIEN just regular basis. on on during answer Sure. Ultra pandemic. probably questions what and we are have we this

some low it’s we that goes time, well generated pacemaker got over I data for has on rate, have so think been stroke, list factor whether to that paravalvular in itself, pretty impressive the wonder important the and a we performance leak, speaks that level had going don’t, thing. to one long in look we high and be of just term how at this confidence where is

Danielle Antalffy

Thanks. That’s helpful.

Operator

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

Adam Maeder

just hoping guys. taking is questions. Maybe Hi, there. the Thanks start to was additional some to PASCAL get for detail I on

I think profile. it you that has mentioned narrow a

and follow-up? color could provide So a is then any the I impact or had just for is think anatomy different how be we efficacy it you should improved clinical there would safety about great it

Mike Mussallem

Yes, that thanks for Adam.

it’s a spacer think all differentiated it same as of like has got experience. as of in the good going all maybe new PASCAL on are And where PASCAL features PASCAL can’t those that are things gain having going a at first say to so still get We this early to night is experience, this So enough question we panels are answers get long-term it fit that deeper we case, physicians definitively be it to almost based got system, going about, some it our how Frankly, we were has to the we those okay, point, a but ACE. still, say, all profile still clinically? the are that basis. that’s in we as expecting the as is a of itself with they use a experience manifest it independent it will oh, the the a narrower compliment, you is to asked

Adam Maeder

curious the if Thanks TAVR U.S. color TAVR then maybe there, had for a that to an QX going Mike. you now forward? are much we number in see in okay. new follow-up, we online environment for Got the added the a think were can sites to just it, switching sites for, for start of healthy And back the expectations at are come you clip? where so the Do what taking questions. sense Thanks

Mike Mussallem

is. I think of data don’t XXX. Yes, know we talked last thanks. what we the them, to reported the remember trying The that about there am fact I I were the about that number time

have on and I back so check And to that. go

you little XXX that give the to probably color, range. the in a bit U.S. Just maybe out we this maxes are anticipating

the rate I don’t they that if top actually my of helps joining, you think know, know don’t are head. I So that the off it, about

Adam Maeder

it. Thank you. Got

Operator

comes state question Taylor with Please UBS. next your question. from Our Matt

Matt Taylor

Hi, thank for you question. the

thinking lot of are So Do growth talk your the you you and from adds when center of versus I center assumptions Can do to about existing question to add new double-digit just year, about a growth? wanted need comes centers you to follow-up much that on that? the for for centers? how next that

Mike Mussallem

of the from Well, that’s remember, smaller. I at Maybe in a are conference, XXX I investor by is imagine good if new that’s going bulk nature to in come specific most growth the there. centers, the existing could be is that’s come to of Yes, centers. the from for already. of thanks their our that. don’t number we know centers, our you growth are but question to growth, going our to going bulk ask not growth existing

drive you can of to kind numbers, you that. these anticipate So just can big

Matt Taylor

old answering to number the and do whether question. is and you that’s aggressive modeled double that this think that when realistic can I the a you follow or scenario you kind XX% consensus digit just consensus a can growth number? you all around of mean, about is at And around there growth everybody But XX% comment are touching

Mike Mussallem

Yes, XXXX. that I maybe consensus say just driven familiar much actually will you XX% probably than that are, but you of a as delivering base with in remind is intimately off lower the which is is Edwards

to about than a what is might sales actual think rather So, in you to want do it more of growth the rate. sales terms

Matt Taylor

Mike. Okay. Alright. Thanks

Operator

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

Larry Biegelsen

pipeline, am for And afternoon, next a in the good XXXX, am approval? list, I but the not for and could you to I interested the have ones, the Mark What interested what data Thanks EVOQUE CE I on laundry do guys. I think on XD what know follow-up. question. most the Hey, if we tricuspid for one – am catalyst one laundry, Collapse Two, And important are are? Mike? specifically taking see the important not asking in ones most year

Mike Mussallem

going don’t I pivotal are to XXXX. in trial we Yes, think results see

I basis. in likely I think do there a XXXX. expect new those on continuous almost are steady data of come to more drumbeat a be to

powerful Larry, leading one on, in going we experiences, are things in ‘XX. going are pivotal you innovations a to that I really going don’t think CE to see of of see I but many have meeting, to on every think so studies, trial, at you have that the We terms you going that first see follow-ups are Mark lot are indicators,

Larry Biegelsen

we to module the trial tricuspid Thanks. out for your there do randomized for could my that data? going you that? it data tricuspid there, uptake develop what tricuspid came develop you think, you does need market going therapies. lot question Like outside guess to transcatheter is of the So be controlled when do TAVR we Europe randomized partner saw of to controlled or do for seem you pretty what’s think before kind like on in enthusiasm U.S. take a with think drive And SAPIEN to before you I a it’s other are strong the view drive got or market, to you

Mike Mussallem

Yes.

you mean, I Larry, So right. familiar, are pretty

even the really off with had data made we didn’t U.S. for studies. up Europe, sales until journey, we big step You pivotal And take this and came they significant in for and TAVR. pivotal nice a those had the along TAVR though in

is having kind on Now, many of lot of for part of that, tricuspid aren’t patients, the them. their like excitement clinicians TAVR, said there there treat a to answers

they so are anxious solutions. And have to

be think difficult. the deliver interesting, could tricuspid but it very predicting can is if still some we adoption So, by rate results, we

that important I can to some for be on long-term make it. results get so think before we us it’s going to

of is TR We the trial. we Of TRISCEND tricuspid Class have II, the of which studies lot was EVOQUE the X, have coming class trial, a which the pivotal trial. EVOQUE

exploring So, finding this it’s early, we your answer have that the Larry. and trials are pointed question, still and real but to are at

Larry Biegelsen

you, Thank Mike.

Operator

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

Vijay Kumar

on of moderate market would either these or asymptomatic? Hey, guys. big Thanks one those, the if for Mike, how around either taking sizing my any or TAVR, asymptomatic opportunities will, question. moderate AS, one be numbers you

Mike Mussallem

the are It’s really the good Yes, about people that’s a that out market in we not be AS. of and system. more to turns significant we almost learn about AS question. are learn undiagnosed The interesting pretty the more

significant AS very patients, population. And that population. it’s moderate is the so to think also for a we quantitatively, And say difficult that think we – asymptomatic a are us we do significant the is

a this able not is driver a this deeper this when would driver going the and we are for been December, haven’t at a it’s competent a basis, it’s but that be little at we very but on in point. one one what those good size point. That We to be together us are maybe to size accurately clear get a to long-term

Vijay Kumar

now for one comes anything we at should about OpEx guess, year trials Scott, clinical for when back dynamics you I spending the when spend gross maybe next reopen guys. up, ‘XX, about look And and margins? on think Scott, Understood. how one FX Thank as restart, open quick you think marketing for or the you

Scott Ullem

field will tell to you fully our of get up to back back operating about to pace it’s talk I Well, trials with pre XXXX customers in have to full what eager look being levels. in clinical in the out our ramping or of margins travel more like may to early be your COVID and permit our

are as it. do ramp so as we expenses will that quickly those allowed And to are anticipating we

terms In expecting big a what we to Ended for from with know is, just which premature to dissipated to happened when of headwinds is expected you sales. say are no up we FX. FX XXXX, FX it in headwind now for XXXX, that sales

And what XXXX. to so is like it just it’s premature to speculate that going in look

at are Although give about guidance more will conference we our talking investor December. we in be when that

Operator

Thank you.

Our William with state Blair. from Please comes your Kaczor next Margaret question. question

Unidentified Analyst

Hi, Margaret, for questions. taking Brandon this is thanks for the on

to opportunity. one focus a TCT this or convince curious is presentations at compelling treatment low year, enough lot think far in treat we of so kind First are And long we is that for a or term collected waiting just SAVR data? durability move been valves had valve of guys is to as is TAVR the I was was there some So that opportunity clinical meaningful and data risk the physicians there meaningful this on while of more today lot this within that kind a you forward? focus. of And is But even patients how of with practice

Mike Mussallem

thanks. Yes,

if you TAVR in valuable. put do report a data We it that And bit that of remember pretty is good are it always and said, so years. really little will, and you goes have year five to SAVR, in perspective, to quality of maintained Hey, quite back life five through A that data and pleased data what about forth, ways. is to

not And had for sure so at time, approved that was we very intermediate even that long.

average of the old. nearly XX years so those were age patients And

get take this even lower risk. and world results a TAVR, if when better. look in improvements and moving have we been to high move like. significant, that look those at And if and results a where as would they risk patients And technologies those you So what were that we improve, expect you just sick see now, fast

with a valve is for valves these valve valve transcatheter a able tissue them a younger option surgery. a big be to having to or avoid patients Just and for deal

community patients really something So we it’s clinical and the especially think value

Unidentified Analyst

just and terms within on of that’s Thanks then rebound the TAVR. kind in going of

calls. prior think in I

rebound the risk leading We now, has within this through classes Thank any broad of you specific you. into COVID? risk discussed a of low all made adoption kind of have are It progress and the kind even that. with classes, happy been being kind opportunity

Mike Mussallem

us no, patients a don’t Yes, level visibility risk of we thanks, to particular question. that gives these the have deeper by any insight

what are You right seeing we are now. asking about

So we just have much don’t on that.

adoption now year. increases, where low of point there once introduced year. saw the of inflection a last terms risk, steep a are saw but seeing at we point more first year, was the same the pace getting last pretty been when to we presented data It we than out In was it’s that a for not steady is it still

Unidentified Analyst

Thank you.

Operator

turn That’s you. it time I to for will for remarks. back have we today. management all Thank the closing questions

Mike Mussallem

and continued in questions are I well, telephone interest Mark welcome to that, your to Mark. much with going for any you, and very Scott, additional thanks and Okay, by Edwards, Back

Mark Wilterding

it Diego. Thank That very much, perspective. from our does you

Operator

you. a Thank you. may parties Thank Have All you good day. disconnect.

Edwards Lifesciences (EW) 22 Oct 202020 Q3 Earnings call transcript