EW - Earnings call transcript Q3 2021 | Edwards Lifesciences Corporation

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Operator

Greetings and welcome to the Edwards Lifesciences 3rd Quarter 2021 Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Mark Wilterding, Vice President of Investor Relations and Treasurer. you. Thank

begin. may You

Mark Wilterding

thank call for and are Scott Officer. Officer, And me Chief us on and Financial Chief today's Mike Ullem, you afternoon. joining all with Executive Good Mussallem, Chairman

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

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

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

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

Mike Mussallem

Thanks, Mark.

to also serve. appreciation the expressing times that who our during pleased the the by our We're pandemic. have needs been begin these patients teams chain challenging supply we highly meet resilient of engaged throughout remained me global Let for

increased although innovative billion to impact growth constant-currency versus of July third our Company due our basis COVID Strong results, than total quarter XX% Turning the on platforms, on year-ago lower sales significant $X.X had by U.S. hospitals. to mid-teens driven the expectations period. a was

the encouraging experienced seek of quarter, what quarter. some impact expect future. Despite the unfortunately recent U.S. We will of X during third and had deferred the the July, U.S. care in in variant Delta on variant we the hospital in to in continued on believe medical QX these months were significant in decline of COVID patients by willingness in impact a And procedures based hospital QX, saw QX, treatment we third who the the Although be confidence especially signs resources the patient pronounced the Delta treated in we're admissions. of last we encouraged in the in deferred many

third Company TAVR across the of share that expect selling stable. was estimate U.S., XX% full We price the XX% low In to to were was growth third the In our Growth sales procedures quarter. in our comparable stable. estimate our our centers. high year-over-year Globally, a growth with was we and on broad-based volume and average basis grew remained both quarter up in an TAVR, versus teens dollars, procedure sales $XXX continue the year. growth year-ago sales TAVR $XX We million be high and basis global period. total for underlying on the global

pandemic. might seasonality and even you volumes and by affected to providers the focus turn were geography patients hospital, as in by QX their again procedure varied As expect by and

year-over-year basis, Delta of approximately hospital the U.S. the encouraging our quarter, July a TAVR in the benefited procedure in of had pandemic, we significant comparable. growth QX to last resources. signs procedures grew on the continued sales and recovery in estimate impact however sales from the from TAVR months were third impacted Our negatively two due total XX% on was Outside

Cardiothoracic of XX. And the Delta, by by low. our growth continued growth, The the the with therapy. centers QX regions. global of in lows. Surgery guidelines in European believe see adoption QX remains opportunities be in We broadly, these the platform. continue therapy Europe procedure in across from acknowledgment continued [Indiscernible] over all We a is guidelines recovered of It's development. that and need adoption encouraged Europe TAVR although was of the significant worth considering rate TAVR that for strong important published an SAPIEN that valves of opportunity Ultra patients We those TAVR recommend Surgical decade strong preferred over for pleased by is strong Longer-term, Europe, resilience recently, XXXX broad-based been Europe definitively we adoption Association volumes. it believe the clear of impact international for Growth continued long-term and over X showed XX adoption quite we in as excellent were OUS Strong is available noting Japan. of age in TAVR TAVR already this represent remains have driven transcatheter a growth relative still TAVR, unmet despite with to a market commercially pandemic in for large, there had society the for in from

procedure based upcoming growth QX availability AS country, to QX In At We update a for on elderly X to expanding TCT QX. that on late-breaking October large focus As amongst meeting, at the surgical low disease treatment fact therapy planned TAVR this be remained by PARTNER expect TAVR similar of remains of driven for risk. received the a economic significantly reimbursement in we we the under-treated throughout expected, outcomes years. there's of the at trends, population. on approval summary, X patients this

continue sales $X impact The untreated. We global of TAVR remain of many ever, We because billion double-digit long-term compound long-term in the to XXXX, remained about potential on TAVR XXXX. low because view growth patients confident annual its by expect growth potential a and which implies exceed stenosis around reinforces opportunity aortic that rate. this will our as underlying from suffering many as XX% of the transformational for TAVR

made meaningful Now, drivers. progress the with outcomes. patients to results on to approvals adoption, turning key unlock treated of portfolio long-term remain real-world and and positive value favorable TMTT, XXXX to to three all our growth date, shaded clinical focused over platforms trial significant pivotal opportunity. transform across treatment A we've We different therapies, support and

portfolio the progressed to regurgitation. we enrollment pivotal across suffering This therapies quarter mitral support trials and our from X patients for of on tricuspid

will trials, gaining look continues trial class are experience track the our will for important presenting We first This data studies several class of with with and PASCAL DMR to key from PASCAL to remain the U.S. adoption be pivotal large class feedback of through year for of datasets precision and randomized trial results platform pivotal and positive. as of We next XD physician single-arm part mark next from transition forward late a from on trials. the approval a our patients and that significant approval year. be milestone support

Eos. treat continue and trial with our We SAPIEN of through transcatheter ENCIRCLE of patients study therapies to both MX mitral EVOQUE the our MISCEND -- replacement pivotal mitral

TRISCEND EVOQUE We II are a critical patients therapy tricuspid importance of replacement without the with enrollment options ramping of for are part novel and comprehensive therapies our portfolio. processing many exemplify treatment Pivotal today transfemoral up Trial. These the as

clinical and presenting data the expand we As evidence, will tricuspid look study. forward TCT Presentations at to replacement London month. outcomes Valves TRISCEND our of to meaningful include trial we of body from in our PCR six-month clinical EVOQUE continue next experience

PASCAL from repair with addition, outcomes over XX-day of study follow-ups our mitral for patients. In post-market clinical Miclast, XXX

demonstrations of case differentiated anticipate We our live also several therapies.

Turning of of sales $XX PASCAL summer the in Europe. in the Delta performance million financial adoption despite the driven of TMTT, were to continued by impact seasonality, in global

support commercially, to excellent experience model. remain employing for rates success our we to patients. expanded high-touch we And continue As procedural committed high outcomes we clinical and clinical

activation We with the quarter. of are our pleased site level during

with RESILIA vision to versus in of tissue treatment COVID data we're year-ago Structural European year. with expect the Despite third billion X% the across continue lives tricuspid to Association to we including INSPIRIS procedure see mitral to up regions. the our evidence $X conduit remain growing cases confirmed our advancing mitral our age and increasing this advanced to In resurgence valves and QX opportunity $XX RESILIA by the disease. steady patients to global Cardiothoracic million quarter meeting previous valve the growth the progress $XXX We is And continued $XXX body triple patients estimate and the global XXXX. global approximately RESILIA full-year INSPIRIS as by toward adoption guidance and our real-world annual Registry million, outcomes of were most MITRIS with demonstrated valves, RESILIA TMTT pleased of period. the SABR million on earlier basis transform underlying sales This were of XX. Heart, Surgical an at to of under Surgeons real-world supported valve. We valve, tissue encouraged encouraged Edwards RESILIA KONECT aortic of excellent achieve by

of technologies. that patients Structural their valve that have they to we engaging are year market the surgical Surgical mid-teens underlying premium believe positions our choices, learning be awareness XXXX we of durability In full and and the in technology. growth As growth their summary, by RESILIA increase our driven Heart, of adoption choose about confidence potential with sales will this for

Care, serve mid-single-digits by year-ago We led U.S. sales global quarter in third primarily through driven sales underlying $XXX market continue the will In contributions from product capital on we up period. was the all to million believe Heart the Growth XX% HemoSphere XXXX. Surgical versus basis Critical Structural strong by an that lines grow were

grew innovations Critical revenue continue help And high-risk Our designed range the used make demand remain believe demand for to excited ClearSight the remained True our the in Scott. I'll the the due recovery in U.S. better of about finger as Wave in used technologies to to low patients. also Care year-over-year in cup in used addition We elevated ICU grow call pipeline monitoring non-invasive products our to surgery for the Care devices elective In and decisions double-digit continue we XXXX. focus summary, smart demand disposable in pressure over turn shift Critical to procedures. to in for to in clinicians now the we will their hospitalizations

Scott Ullem

color on unfold the what quarter Today, the expect perspective along basis prior additional third some in rest the on investor Total Xth. I'll year year. to anticipate the at the on of December XX% may conference and how grew the underlying Mike. quarter, an we sales provide Thanks over on third with

growth spending -related As more of expectations this than Delta COVID sales as our $X.XX expected Earnings we in met indicated strong than U.S. the in sales. constrained surge. lower-than-expected earlier, July before is the offset lower quarter

billion X.XX improving as and X.XX on the $XXX procedure reach quarter TAVR Delta potential million still and projecting for underlying around And to with trends line, based for Care. We're XXXX. product are QX the of mentioned, ranges Structural we're sales the variant. October each $XXX trends, sales Critical Heart, to Mike also we between of A total our TAVR relates to billion. forecasting maintaining As Surgical and TMTT, it sales XX% our the full-year previous growth million of have fourth

to adjusted with fourth-quarter the continue XX our full-year adjusted We per cents. $X.XX XX guidance high-end earnings at results. share of $X.XX quarter cover now additional to expect EPS I of details will of And our third to

exchange. continuing a Like logistics. year XXXX. And we're also XX.X% are improvement impact of up delivering use hit some shipping capable costs by responding as generally, for offset products raw companies, from things strong we margin our some ensure and that of investments to have a and that like our impact our profit profit profitable same in the the chain said, guidance negative or net the partially resilient we was costs XX.X% for and in period gross life-saving supply experienced of gross is adjusted performance driven is we when to more More signs patients. year broadly, the our no well foreign incurred lessened. as inflation, seeing substantial last by result With materials COVID extraordinary from margin COVID, last mix, most was of in to Our the when product we production, material

to We expenses in $XXX continue million was to prior to impacted costs profit prior increased margin commercial between our sales were the million compared XX% increase gross $XXX primarily administrative compared be third XX.X% personnel-related and expect quarter of XX%. and COVID general or and year. the by XXXX in to year. This driven adjusted activities Selling the

items investments quarter prior This a a and expenses increased or We ramp development transcatheter excluding of to was to as related as still sequential are be of expenses continued XX.X% XX% clinical million the percentage restrictions expenses the fourth our SGNA the $XXX XXXX of up Research planning grew to result in continued primarily activity. expect XX% full-year trial increase sales. subside. XX%. the sales COVID including in special of We quarter over year innovations, in to

to planning these increase developing we evidence new expenses TMTT. as TAVR in indications expand in to for are invest technologies the We fourth and quarter and generating

of a For XX%. the full-year XX% expect XXXX, to be R&D sales we to percentage expenses continue as to

Turning to taxes.

rate this for the impact tax from the items. was or a This stock-based quarter reported XX% rate XXX-basis XX.X%, excluding compensation. benefit of included Our special accounting point

our benefit in XX% to of percentage four items special rate and compensation full-year from excluding We an continue estimated be XXXX, to including between stock-based points accounting. expect XX%,

to year. the quarter an sales or about XXXX continue current by third to growth points reported $XX X.X%, XXXX. impact, we approximate increased to sales, compared positive million prior rates to $X basis XX expect rates, exchange for compared million At full-year Foreign

future rates capital third operating prior are our are our technologies $X.X spending opportunities. quarter of exchange margin cash of flow penny. from billion. strong the flows cash to was returns previous July which by exceptional our cash million, a impacted per portfolio basis defined to of than as free share investments, negatively less from guidance, cash earnings less impacted to reflection gross external Free profit activities our $XX was And and us million $XXX allows by positively generating $XXX flow year. of for compared flow quarter patient-focused The quarter third points relative year-to-date that internal Foreign fund million our third a FX XX rates the

average million maintain $X guidance of a XXX Sheet we the during at and We as be lower continue our with our to XXXX billion XXX continue Balance September of Average shares to for range. outstanding strong third flexible investments and shares quarter approximately XXX outstanding expect cash in XXth. million end the and diluted to were to

billion program. remaining We have $X.X share approximately repurchase under the

from premature Before call our turning disruption I'll In Investor make we It's provide quick about offer Xth. guidance XXXX outlook back guidance margins, COVID, at XXXX, detailed to Conference changes to we're with in visibility general, financial provide less we the rates. pass and impact over it our comment and on as Mike, that, well the December will back more to assume as more for as of Mike. earnings And any normalized profit growth, XXXX. planning but into sales in a today, will tax operating guidance potential I'll from resumption for on we gross corporate

Mike Mussallem

Thanks about Scott. very clinicians strong as And patients and opportunity. performance We're valve choose associated year-to-date long-term therapy, our remain the the transcatheter despite headwinds growth pandemic. the we optimistic increasingly with pleased with

wane. the to with years disease that, there I'll growth aggressively drive remain investing We it broad will to the over suffering will that our resulting strategy, Mark. committed are come. confident impact is of to patients back a to group in we turn therapies organic in continue focused believe Structural our investments still from innovative strong from Heart We innovation the because pandemic's and And

Mark Wilterding

our Investor Xth, will Hey, a heard lot, take And as thanks at from earlier, Mike. on our here headquarters Irvine, you December XXXX in Wednesday, Conference California. place Scott

way, of we For webcast. be and you conference really those it. will with a us also appropriate available join be will can of Either the you campus, precautions, be there able safety via to hosted hope part on

you'll In addition strategy and our about pipeline. to product Edwards innovation our exciting hear comprehensive focused XXXX and financial guidance, more

website at of For please Relations visit more section Investor ir.edwards.com. the information, the Edwards

to So, take questions. with ready your that, we're

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

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

Operator

Our with question. Thank you. your Instructions] Vijay from question [Operator comes Kumar ISI. first Evercore Please state

Vijay Kumar

one, it respiratory where season flu a helpful. be on guys. between further So, the from to be the Maybe even COVID? hard QX Mike perhaps future assumptions flu some versus taking my perhaps first here. the traditional Scott, question. of the disruptions assumptions for What in perhaps or Hey, are any QX Thanks for guidance will base or symptoms might here underlying the differentiate terms commentary

Mike Mussallem

precisely are all Yes. Thanks, the know Vijay are that so We in Edwards’s business about really with and and U.S. down that we the handle their we're projecting in watching to we we to great from it heart volumes we fundamentals struggle for strong it that many good but disease pandemic a patients ability the ends many impact great particular the there others, in pandemic. and news on with spotty. come like find where of very place, is are the the need. in very structural feel the that's and having and impact good. most felt and in able It's Delta up is variant hospitals nature regional the that's be perspective,

a there apparent is there of is some concerned be Of not course, point. winter will of kind at that this surge

always So those things are possible.

by fact to have and modelled things better. going get We that, are gradually we think large the

are taken in what the saw that October, October. in of of We where run have account rates we And couple in months QX. into last similar to saw we were we

And gone our that so has also thinking. into

I your So, answers Vijay? that question, if know don't

Vijay Kumar

number And handling No. when comments Mike. That's be I on issue on labor spoken of hand, excess shortages, capacity about a about to or it volumes, feels last them. think hanging backlog I labor shortage the helpful, for hospital and one the challenge the might been has around guess [Indiscernible] of the like just cases centers limited

how curious patients side, making highly volumes. profitable hospitals the should be for to quickly, so too. procedures, are drug balance incentivize, pretty this conscious are where perhaps you we, these I'm perhaps, case Mike, flip sedation, out On in and

Mike Mussallem

pluses But just sign up elective We're by stop isn't ICU or that, not. when do is various it's consuming whether resource sometimes and and and the happens decide going that just what they're the it's procedures it's associated or that's with whether No, reasons impacted and case. always not that often a we Vijay, patients, COVID an swamped with capability. point, one or more staffing stay. to with they're the it are watch the TAVR the they probably they fact great for put will of But Yes. hospitals not there just ICU

bit hospital just this more hopefully it's have to answer one because across but hospital a with you so of a I a provides Sometimes bit don't little tends broadly color. bit for with all it different, snowflakes it little the be being

Vijay Kumar

guys. thanks, Understood,

Operator

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

Bob Hopkins

Thanks, Okay. are Mike, in and forecast. time forecasts. about it much make you How And good What there I'm you out and know better now, ask afternoon. what a views on, challenging what month realize curious it's would environment love your I just we about ago. now? a was is the seeing I to won't than

on, views to I'm ago. curious TAVR just now your much a net few Thank relative are Just and where you seeing, months are specifically to were improvement we asking a see you. perspective. where from right How we

Mike Mussallem

really It's Bob. thanks, Yeah, good question. a

so give than some general, we team You're our too a earlier October but of granular basis. gets watch hate In things let I it the even today was probably change adjust And tough. Bob. QX. daily to end are a and to their you I they sales on things information. than And based dissimilar the each to that, know day that on to were daily in on too close stay almost you month. the But how I get feelings tried own things, better hate not granular, get little that

were of that not a sudden back that to we experiencing in signal QX. kind the October to it's thing of send -- didn't is So, we want all a

part. I is mentioned environment we that an to Delta, lot but of a ICU stays, think overall a pay these yet, turn folks, bit a that's experiencing happening with COVID, into optimistic. not improving think. probably later, a but of we affects of we're bit on kind our what's I talked trailing of indicator maybe little of is a is speculative to trends bit anecdotally, we off, our obviously the -- cases and that So, Often that mean, the -- we're TAVR that it ultimately something going caseload

Scott Ullem

I'll you XX%. Mike said. something Bob for for and QX is, forward, is if call the have in roll which things it rate a just QX, just check what TAVR October, looks been did it lot like Which growth trending that like on

So, And moving looks try it's the of all of underlying and watching under growth But we're to something that's what year, to for full overreact like you around, to rate you we've about now, like. gets trends had Mike if carefully talked the not nearer it the react looks said, sort are then it it the XXXX. right for trend what XX% to sales call daily like. that

Bob Hopkins

then helpful. quick is very Okay. for question those time yet the you, we'll that Thank in there see on for And is, early or trial and U.S. a Scott. That's last data, when XXXX? sometime PASCAL just set just

Mike Mussallem

to we'll to the clarity on our We with for for next be be be going will that one by a Bob. and more when end conference, clarity that it we really hopefully, at approval investor give date But sense presented. when of get we have our be I'm trying the you have will say we timing have when We're visibility we have next that we'll a time. to year. don't bit that belief little on don't the That'll year. it'll it's sticking

Bob Hopkins

Thanks very much.

Operator

Thank you.

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

Robert Marcus

questions. Great. Thanks the taking for

or year, this numbers I Europe earlier in the competitive Valves newer little the European this with recently? in me, look still know looks to saw we for shift to one trends competitive some it's good maybe quarter, days are of that more early some reception data see you X. any but starting First a SAPIEN and

Mike Mussallem

throughout that the the been past. feeling The answer it's year we've the no, is case was that short very in similar had

and competitors in is seen significant other haven't of that, up We top two rest, if in that's shifts XX%. Europe, all a make We competitors, the helpful. the that really complement sales XX% think any continue the up make to about full which the of

Robert Marcus

Scott. the think potential Where spending maybe no is business. for is. margin And one fourth COVID think environment. where we about leverage it maybe expense. are Yes, versus talked from a the where another operating quarter, gross quarter but do you and we in financial of -- This a more saw Perspective do you you

said fast way, forward margin you this like And if COVID, there's versus and impaired the maybe here? SGNA much another unrestrained more have and improve no So you to does from what gross how in to maybe spend would is room RND environment.

Scott Ullem

We do we're think gross margin from, relatively operating margin, mind has room our starting industry. from as already margins to does to improve strong compared keep in

- So, aggressively carefully it's our opportunity though, And on remained be to by investing about. Short-term going driven COVID, despite so something are I the try down expenses down that to incrementally, But pre are the relative think remarkable, in Because been expand think to internal largely on it's things priority question been more your has margins levels. as to expand for to that field. there's do slowly time. growth about are we gradually, sales pretty than that over our Covid margins. fact out those margins to well, have stable trying happening

different So, attendance travel, societies and events. at meetings, various

trials we'd a be that. we've kind that the expenses able we're because we're sales of pre-COVID. from so, To rates we invest from go that along our to natural normalized, And to an though, honest sales we saw seen clinical up hedge headwinds it's see COVID. enroll higher more can back the the with environment aggressively against been it's at that that and indication that is like benefiting

about And margins so overall. we're the that's way thinking

Robert Marcus

taking Thanks Great. for the question.

Operator

your next please question comes Cowen, Our go from with Jennings ahead Josh with question.

Josh Jennings

Mike; the to so on a in that I thoughts I for updated evening. wanted questions. the your call. bit just the Good second learn much you earnings quarter hoping little about Hi. to taking was start Thanks mentioned backlog

that of the thinking and in that just be phenomenon just move we the kind one, as of peeled investors referral And should could channels the with bit. through sideline coming But XQ COVID in little back this review off a that's patients reemerge surge. that Assume XQ. XXXX any environment

Mike Mussallem

key do We talk quite a on visibility inside. perfect a perfect it and you're Josh, we Thanks and have point, don't bit data. about

feel much some us happen as the last patients result anecdotal back on when our small difficult for tough lift magnitude the system. that try XXXX, nail we March/April the we But similar a reports kind of probably got in some it small stopped deferred us those we of might it's in Delta this, what speculate to a the and some a gain [Indiscernible] back indeed quantity differently, come timeframe, kind did, showed winter's additive, the and rely timing specialists back we of back the So for things deferred variant. but like of front-line a during into up our and supplemented system clinical QX. It's and of when those. thing to clearly, to care that not giant came time say the lot from saw we patients in of that customers and care. patients perspective. felt number total the have its with patients into but the It's that of first we QX we pandemic like had If reflect on spent --

provide these variant diagnosed speculating actual we're Delta the got the their have to again, may we During the that there weren't regional actually patients indeed treaters in but had therapy. physicians hotspots that saw and

see So, similar this but that is we some back as exactly come is it wanes, when might were hoping indeed, we back a very difficult as we saw phenomenon COVID there think QX. reason might in come why

Josh Jennings

that. for on one low-risk then we and just follow-up penetration. And Thanks of just get a lot questions

patients was presented XXXX, seems was the for update low-risk. That registry low. TVT the couple a think weeks I ago. of I update seems TAVR think It received XX% were And pretty at of of of like penetration, terms lot. in terms just in low-risk would market Thanks opportunity. to early where in we're still get the your low-risk that penetrating is, of but thoughts innings TAVR love a

Mike Mussallem

or Josh. it's spectrums, Thanks, patients low risk still in think a We being intermediate variety them problem cases, there across is appropriate of still tell think problem reasons an innings it. early an the We're was low them. you way and characterize many for many option risk, all risk. We could for receiving under-treatment don't. whether high TAVR I the therapy I wish are available good surgery. and of to -- risk they there's the for be that that think that not I It's for of being aware just should risk, a are

if tremendous And number. would put are and the a been progress, across us, steady stock has than worse even penetration for so, penetration we're in initiative progress that it's the rates we've In we and been border slow I don't not I that. know key general, think but close.

Josh Jennings

Thanks again.

Operator

you. Thank

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

Matt Miksic

for Hi thanks taking so question. much the

overseas as less what areas Europe have despite the in And one one you market see U.S. there's I and then as staffing issue if QX the on. then the strengths The if surge numbers U.S. that or one challenges out general whether see an went on trends. Just and it and U.S. pretty follow-up. performance -- you I outside came of drove curious tease in on European was awful just other the everything to Then and regions been you much an of overseas surge, lot that of staffing the being do sequentially good I'm just than is on be can follow-up focus and could, but TAVR the impacted around Obviously U.S.

Mike Mussallem

correct. impact we Europe. saw We the was saw in observation than in your No, U.S. far Matt. a Thanks, Yeah. more

growth versus it's in to Europe comparison, growth XXXX. were had actually Europe, poorly. rates. though was my And QX doing not you Our back a pretty They comment colleagues in healthy that last notice you'll of quarter year, really go if as by

I I say something or to growth think all high-single-digit last want year.

that Delta this way considering growth did reason, significant pretty And is which introduced it's impact on the didn't for was pretty growth, top back this of in European during have So, in it variant a still are Europe here centers same the to the is 'XX, U.S. seem we They, in even growing pandemic. therapy whatever mature. the

Matt Miksic

to Meeting growth up thing in Analyst expect what comps Meeting the be a Scott, can comps year have basics guess, had the becomes That's just past of you laid into of played start way great. Investor 'XX, your curious out one less I December. for the given you great bit then bullet like hear know I TAVR, if in and issue When be I which to is But could, frame And something years, a has a there's that the mentioned year-over-year, out conversation normalized 'XX for impact little whether given and expectations of points out? of conversation. then back come think the or the year this things I'd and heading say, you following growth. seems you one decreasing potentially expect to to to And, I in we year. of some or COVID at that,

Scott Ullem

extent get XXXX Japan the to the to XXXX, question the have our of for the less are U.S. growth definition, overall, feel really in we end COVID positive and for guess in and prospects we the to probably rest example, about going prospects the into meaningful to quarter, that in sort playing uncertainty we because of in the and Well, role the be the and more about Vijay's that's for are more when the rates, overall. quarter, I Europe hotpots on is seeing we in a as windshield, by TAVR lessens the important noticeable going growth world. If we biggest and that growth comps certain then, going to fourth more rearview higher. start COVID growth or just think regions are as That's that it first beginning then but earlier of back about the do that mirror ties impact

factor. low-risk It the that the earlier shortly for thereafter, while ACC PARTNER we a we're quarter about with our this of talking in interrupted for penetration. we're penetration things timing third low-risk, and the calculate data to low difficult it's at growth approval got have we in actual risk, X of where XXXX, One Remember COVID the became TAVR. on the XXXX

haven't time reasons longer-term this approval got COVID one low-risk great we extent they're that's growth since just And and the period it's really of so, for uninterrupted any we TAVR. of for think had why we from opportunities the

Matt Miksic

Thank you, Scott. That's helpful color.

Operator

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

Danielle Antalffy

be from Europe. wondering a you going know on a Hey. could is, premium Good it I so to in we need price but if data guys taking that. I at afternoon, launched presented that's strategy. you plan little early, everyone. was for just what next that's set you bit the question and nitrile the Pascale to talk had much disclose the Mike, year. to Curious question. U.S. about the Thanks for the shifting whether see U.S. about I launch can if now. if it's

Mike Mussallem

Yes. No. Yes. Thanks.

also We're around be from As TAVR to launching going views. again consider and we've steps capabilities going do the would we learnings TMTT therapy some We're having just PASCAL In approved that they the outcomes. some implementing and forward approach excellent dedicated be of it and a the to the team in we how PASCAL taking already 'XX in to indicated, take will we premium world. advantage build high-touch and premium focus would DMR assemble of end globe with done our general, for real-world of our elsewhere that our on are implement had would -- that in would on and color we initial getting by gives a what model. a plan looking the all Europe. we're launching Hopefully, we're you little pricing will field be this. And to really we've approved consistent

Danielle Antalffy

TAVR to so the as centers specifically do about superior you question follow-up Thanks centers? That's How I the mean, TAVR to initially, will go target the And as helpful. target leverage very your initial I to is, we have market share, or Micro then think Center? is much. existing centers target far plan

Mike Mussallem

say Thanks Danielle. little evolution. an say, and do early might to teams. this In dedicated the investor you. together be interesting going the for people that we're early mitral is color there's talk other at to too It's about do going when It's same any We'll little don't we're a cases, a cases TAVR I get really will to some it. to more to have into us have for conference. But specific now, right

Danielle Antalffy

Understood.

Operator

with And Stanley. Morgan our Furlong your from next question. ahead comes go Thank you. with Please Cecilia question

Cecilia Furlong

of question. ask, you perform about how the centers, throughout low-risk kind Mike, this And TAVR near-term to to Japan, certified the flowing Great. reimbursement, well. the XXXX of as landscape over just TAVR, terms trended? wanted are that about of Thank think that's then then seen the into taking and as outlook what and I for year centers you've there you in given

Mike Mussallem

Yeah. Thanks.

TAVR is the Japan has to even growth low-risk and other clinicians " for key. it than to happen And world slow hopefully "Boy, low-risk growth places very So, I a was get at reimbursement mid-quarter, just were requirements already indeed get are our international pretty we're the in be That important. ramp to fire want is And centers that still have to quarter. this necessary new an granted are it added. added think said way deliberate it's tend been in but centers. But basis. rate about TAVR It's that Japanese Japan. those able patients we get to the it say, example, helping the in ed of, be centers growth. up. higher there's There pleased to population. regulatory think a million, say, was exciting to the that It's important And importance that, Those the approval. new in having we last we a I for under-treated until So, significant large -- a are that terms the rate, that their pleased to elderly August. There begins reimbursement take redefine of long sometime around They and when go. very for Japan new very in up got present in dramatically we've disease per on get to

Cecilia Furlong

ask Okay. COVID well, in seeing just ramp XX, Thank when TAVR any Great. you're could on early landscape given enrollments, clinical expect to on And provide enrollment you as updates the you if you. or and to I what wanted and there. either

Mike Mussallem

Yeah. Yeah. Thanks.

our of of make adjusting but It Delta. have that the You nice not same on Cecilia, might during there we done said doesn't enrollments. recall impact was that We're They it and trial way have on up easier, that committed teams. flare early this hospitals experiencing very adapt. job a

it's latest And we've trials' our that feels trials We has TAVR, our it so, in by basically TMTT, feel trials timing surge. not like impacted this our done well. in whether been

Operator

ahead your from with you. with question. our next Thank Please And go comes question Biegelsen Larry Wells Fargo.

Larry Biegelsen

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

our your Europe Europe. like from reached math, Mike in in one share about looks It after kind PASCAL, about share Just of years. inching up has X been by you've and me on XX%

So, to market my leader. goal question is is, be what know that gets you I a higher? your

it. they using share? DMR how you think do need using it taking DMR Thanks need that -- gets FMR, for get RCT and the PASCAL you rent your What So, data, do Europe? are they share the What is you the physicians and broad? both in label for or to up? Are using believe it mostly for are I

Mike Mussallem

as gone thinking our you really that haven't frankly, estimate and into Larry focus. Thanks but imagine, this might it's difficult that's we to shares,

ways, see a is That as actually available will to impressive you results. me what's time and see commercial X going that ask data show And is clinical see our and share team. focus trials we've over the pushed in up clinical both get results. experiences day-to-day take our that to our on your patients within we clinicians become focus and results. you experience, our they up, clinical the And been and has to to going outstanding information. that's other some more to get Our where one of and And when to of going you chance when get it's it be more within

are This that not a and our the is just opportunity. big where is There being So in there's TCT, many country point, on patients but I this again At we're with TV think experience. our regurgitation at the Europe early well-served share. our on every upcoming so really many clinical focus mitral today. you'll of see not are not underline just in even or That's some even indicated focus point -- is. information not to more

Larry Biegelsen

Mike. Thanks,

Operator

Piper with Meter question. with Sandler. go Adam ahead from comes question next your Please Our

Adam Meter

good the questions. afternoon. for taking Hey, Thanks guys,

how recently from can and how the any you early that more going one Just just approaching broadly, TAVR impact And that specifically. the and on you here, I but you market U.S. do then seen the of the impact new it's from pricing There's potential this player the know in is a new marketplace so a much. entered have see comment competition competitor TAVR market. competitor third market, Thanks maybe anything standpoint? forward?

Mike Mussallem

or in broad-based, global Adam. Thanks, procedure but We was that growth it really about Edwards of was here results our didn't see anything volume, about whether our results, talked we terms comparable. growth, share. U.S. noteworthy talking the our said Yeah, we the was were and what when it results,

a So, of we've complement mentioned full before that in Europe. we have competitors

but And just data so of that may U.S. we the in haven't indicator, be leading some in seen anything the a kind

Adam Meter

Mike. Thanks, Understood. Okay.

Mike Mussallem

Sure.

Operator

question comes Anthony Please next ahead. Jefferies. from with go Our Petrone

Anthony Petrone

it in is the follow-up seeing And X issuing Consumer makes here open Scott. just we Day. Thanks. Company for guidance? quick period make want as albeit markets. I more move facing on low-risk to vaccination sense and in opportunity that of then a the expectations a just does the of It's PNL question top-line in to Analyst eventually up Is But Thanks. DTC Health to med-tech, on low-risk, in guidance areas sure. antivirals. on higher DTC or it's are we advertising all just

Scott Ullem

talk forecast statements. going to the we whatever provide about conference, when rest clarity other sales financial rates relating guide operating And dollar gross and end metrics for get growth how we our the up the line upon we're also guidance underlying got investor on based we've thanks, to year December. to. enough Typically, we'll margins, margins, to margin, is top and Yes, and of to income about the Anthony, the for to ranges expecting talk

more all As the can not specifically a part a care referring physicians, it of resources get patients driver important offer be be who It's and going investing risk and particular are future. to we'll that come activation category. symptomatic already patients, aortic treated that's to more and some into, to so, an to patients Mike DTC, severe the start relates expect is getting physicians, directly think that then We get the growth of really to perspective at trying in and and stenosis, well. I'll in to primary aimed doing and we We're long-term of as to TAVR, future inspiring have we growth. around patient important of to a market

Mike Mussallem

Yeah. I'll good it's Thanks, question. just pile on a Anthony. there,

the But the were dramatically sufficient. don't way in base historically, early under word we've and days to years their really that of be counted I learned insufficient. back, d. And getting physicians know go we that's referring educate you actually out we TAVR, on If on TAVR did the we would the the impression the over that that's that counted that that

way things the Conference. experimenting of some specific regard be could with that progress in We've terms And doing to do so, and come upstream far although, you We're indeed, the we as the share maybe gone we that in all specifically good you going But be when that we're more specific, satisfied valuable that some to where to Scott to said, a believe some to we've referral right a base roads is, are have from make lever. Investor made consumer, really here sure now. on educated. number of there,

Anthony Petrone

Thank you.

Operator

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

Joanne Wuensch

will call of one-time In and strength XXXX couple how of with particularly for you it Care? to pandemic. quarters into thank And associated to on Is in out question. I much it's just last it Critical want possible been Could underlying? the just afternoon. the taking Good it or of, we words, 'XX nature minute sort a tease other spend strong. continue The have that is

Mike Mussallem

Thanks.

So, here, mean, you were if it's a our I to XX%. ask Joanne. at good keep to growing going question, you're teams

that quarter got made that by difference. say, orders not we think That that's this out. they'd I a realistic. U.S. no, helped some help And really capital large some

maintain that that, growth in all are think to very they of Is going overall, ever? think averages? are regard. sustaining with kind or we pleased I pretty growth Are than Care? true, this Now, That's than innovation on hitting But Critical I we're a of rates proud med-tech healthy it rate able better to did we there that being terms that more in what's not are continue going of in hard in these quarter. of likely. and we're those

Joanne Wuensch

cash. use remind you. on of And As of a thank topic? Can us your that follow-up thinking you question,

Scott Ullem

Sure, that on cash. I'll Really, one, use Joanne. tackle Thanks the changed. not priorities our of question have for

with we growth make internally and that is We -revenue. long-term priority organic companies, external first sized to for pre generated funding that small investments, those to that fund we're we'll early-stage sure platforms. so Our fully supplement usually want buy prospects are

based being milestones in we invest or upon options targets to companies certain met. Sometimes acquire

going back externally And opportunistically. at sheet. repurchase And to so, do we that's an a to important beyond think balance that over growth to been consistent looked capital internally as we to that be way and we've going the we're continue of shareholders shares you give know, And we than can time.

Joanne Wuensch

Thank you so much.

Operator

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

Pito Chickering

Good do those afternoon, low-risk guys. in follow-up the half back patients third those quarter? And I a of questions. 's in that year the quarter? versus the the specifically low-risk on Like, impacted in you see if assume the patients you look curious finalized fourth quarter Thanks Just at how taking in my due COVID. for much what to patients, second question. you do Josh penetration where

Mike Mussallem

again. done through risk, at this first associated FDA But minimize sure that and of for intermediate so characterization sickest oldest were there the try TAVR the Yeah, was -- a taking the it to thanks before, I the this remember risk Pito. a risks treated and by We've character help highest patients high you regulatory low new characterization to apologize patients for therapy. as pathway make risk by risk, is said with

regard. intermediate. to real We they whether key is in And that risks spend are time the TAVR and that's the frankly clinicians really actually versus are We less patient, not live about it there live don't with differentiate look aortic is less at liking concern What spend the whether If It's and for question. stenosis? or survival? low-risk time, surgery. patients, were talking you when with perfect any risk their -- what surviving you is how there, they we were themselves did the quarter. said there infer think third the another indeed where stopped before, they what that, -- primary tried think don't that do quarter? we in have getting and We were were patients, patients treating but was we a the screened. diagnosed, were I just -- Having cases indeed indeed impact number they seeing But in behave as of visibility hospitals the getting doctor, taking to --

Pito Chickering

and a enough Fair for Scott, question then final you.

aren't You pretty guidance, TMTT a wide changing the range. that's

at high occur range. much. the the end low would Just what curious so have Thanks end to of versus

Scott Ullem

reimbursement in And businesses the clinical to like and expected is up enrollment quarter, our fourth and of trial a different will One TMTT a position we're range we now. in going $XXX the million that in full businesses, where expecting U.S. to U.S. What in patient a year sales. to really to a to to that good elements our in where going we're commercial growth things sequential XX the this PASCAL looking of for in where there And and the there fourth question. QX, normalization end quarter. is Europe, a how other for are contribute both where the be plays depend for flow that's couple of be right go TAVR of we're a Delta important of selling other upon factor then primarily. the lot much is in determinant is is Europe an That's in There variant And

Pito Chickering

much Thanks so

Mark Wilterding

Pito. Thanks,

we more question, for one think time I have maybe.

Operator

from Guggenheim. proceed Thank with question Chris question. your our comes you. final And Pasquale Please with

Chris Pasquale

TMTT quick the enrolling in. TMTT script, in on trials said the me and progress squeezing in Mike, you made -- on your for Thanks pivotal you then TAVR. X X five X quarter.

details actually Any I great. includes think XD class X clarify, be has XD. just that enrolling? group there To of class would finish

Mike Mussallem

the our to haven't really approved we're that will naturally that We XD to imagine, go completed, to that us believe allow we and and enrollment we're when specific to late process. we don't say on infers as gotten we're that We that. for But by committed -- that that close going might specific really through XXXX, comments. have prepare having have PMA you

that more of get happen. granularity little when investor the together has we're conference. We'll at lot a So, into a to

Chris Pasquale

But in not Okay. to that know AHA patients. future what your it I Then there's we it's understand looking and -- at breaker from instructive think AS about late so about that's not weave what in could curious as trial, the we early you’re asymptomatic extent there. the be if It's see might a TAVR. you at data anything

Mike Mussallem

personal should Yes, as I of feel through knowledge I it's to to treated. for how these think with and and of have And about really can't feel we we're symptoms outdated are via like thought differing change and about treatment trial a am good good that really partners a I trials. comment clinical asymptomatic know AS. trial, AHA about what committed very care question. both are referring and that strong I patients. that you're rigorous -- that an it. they decide But not The you We waiting so precisely patients don't patients sure be The organization process.

Chris Pasquale

Mike. Thanks,

Mike Mussallem

Scott questions and your continued any Mike, will Edwards. additional Okay. Well, thanks in I welcome interest and all for telephone. by

Operator

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

Edwards Lifesciences (EW) 28 Oct 212021 Q3 Earnings call transcript