Edwards Lifesciences (EW) 31 Jan 232022 Q4 Earnings call transcript

Greetings, and welcome to the Edwards Lifesciences Fourth Quarter 2022 Earnings Conference Call. [Operator Instructions]Please note, this conference is being recorded.

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

You may begin.

Diego, us afternoon, today. much, all thank very joining for you and and good you Thank our With Mussallem, Executive Ullem, Chairman on and Financial me today's Chief Officer; call and are Mike Chief Officer. Scott Zovighian, of Katie the Global for Care. Leader Chopra, of Larry of are Life us joining Zimon, Surgical Leader President Global Structural Critical Q&A Edwards Leader Also of our our and our and the Global of portion call TMTT Bernard TAVR Wood, Daveen Sciences; Heart;

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

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

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

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

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

Thank you, Mark.

making progress potential our XXXX, company patient of milestones care. transforming term, on focused long the the strategic stayed meaningful During on with

X%. still negatively sales, environment impacted challenging the we grew While

optimistic XXXX. that expect because remain will sales pull we little in improve on forward, and care to and the didn't of environment didn't investing innovation We we gradually back the short. a Looking growth fell health back because X% pull sales pandemic, we XX% in

invest for leadership which challenging to in of period, a era during sustained innovation. this and structural critical the company aggressively new positions continue We care heart

we We Looking performance, approval Surgical launched strategy. received back of in in the the RESILIA PASCAL leadership strides and of promising at platforms Europe. position SAPIEN Ultra our long-term each demonstrated received In through XXXX, X extended Structural Heart, important for the executing TAVR, approval in we and our In we U.S. Precision innovative clinical TMTT, U.S. our valve. launch and the in made MITRIS

adoption in drive Critical Care, transformative our And to of we technologies. recovery smart continue

balanced our we anticipated sales Although delivered our XXXX environment, product better expectations initial regions. across and a each of groups for contributions

XXXX. cash We organic while at reflects more R&D with at opportunistically Consistent than accelerated achieved our XX% growth. durable XX% driving sales in we which in adjusted growth an sales, commitment maintaining to earnings our deployment stock per level repurchased of strategy, share

made We in of invest and continue growth. future investments external capacity of production promising technologies. we a to our early-stage anticipation in in series

currency our results. fourth sales $X.X total X% with financial Turning basis guidance, a on to quarter our grew company billion. constant Consistent to

of the our care key of health Our geographies. drove disruptions a growth innovative broad in despite portfolio this therapies number

RESILIA SAPIEN countries. In X the XXXX, $X.X health of of due in $X.X billion and the to our were on sales basis, increased ago in announced TAVR, growth approval U.S. $X.X to foreign constant of care global original in XX% X% challenges on Sales a Ultra building exchange induced below billion billion the period. TAVR headwinds guidance XXXX Covet In year full we year currency nearly key

for and reinforce the moderate long-term XX. next-generation trial we Separately, transformative gained our pivotal PROGRESS to learnings developments growth from significant continue SAPIEN interventions. advance valve transcatheter-based AS These to technology, our alliance study our in patients TAVR confidence pivotal enrollment aortic trial of strong in the

fourth with In Edwards were quarter, procedures global comparable our growth. TAVR the

Our TAVR procedures growth. I were global -- say, comparable global Edwards should with

global Our and expectations. currency a $XXX X% were dollars selling a year-over-year were over of local sales slightly up TAVR consistent constant basis, and with million on currency on in our increased stable. prices constant Sales QX basis

U.S., TAVR mid-single-digit procedures grew the Edwards quarter fourth the In range. in

the was procedure We TAVR stable. volumes slowdown. hospital holiday expected, fourth share and of our that As by procedures constraints staffing U.S. were quarter season U.S. impacted estimate the our

larger the Daxferns in rebounding. by was with is Index. as suggests higher and We're Health states fewer in Growth which recent COVID the trends, restrictions in employment hiring Containment volume centers that and by U.S. hospital measured encouraged

As of house. record we of Edwards addresses the SAPIEN in mentioned, RESILIA the the track performance Ultra a valve technology of began following primary Surgical causes reintervention in X introduction Resilient the anti-calcification demonstrating replacement and U.S. we is strong of one issues heart

valve of been newest in this U.S. approximately now, encouraging. of TAVR has XX% has feedback physician and centers As introduced been

term, low. procedures adoption Outside comparable. the Edwards geographies outside for faster see QX, even fourth growth and also the believe In in TAVR of excellent mid-single as U.S., total digits, opportunities Japan quite of was in remains the grew procedure international and grew growth the we quarter. quarter, we in we TAVR of estimate Long Europe

our global Europe, of prices Market capacity, staffing line hospital remained with In larger and and shortages, And which throughout selling continued cases as a countries the leadership rate. grew in impacted procedures COVID stable the particularly in are year. position broad Germany. quarter there in reduced to the even by though fourth such local range bump competitors, growth be a

France, SAPIEN offers and quality over and are use study with to TAVR published three data when Italy SAPIEN surgical treating in economically demonstrated earlier cost-effective option valve long the month German TAVR with was cost-effectiveness beneficial a These the this suggests in compared X findings the low a that consistent enhances for cost-effective term. The that risk. Importantly, replacement of life aortic surgical Spain. patients with outcomes of

In staffing Japan, COVID slower quarter which growth was procedure and much due capacity. wave limited restrictions, to and than continued an expected fourth extended hospital

of to in over substantially on TAVR the XXXX look later factors SAPIEN course AS elderly by availability to the launching diminish this amongst Ultra undertreated these therapy expanding forward focused driven remain Japan the that fact expect We We remains large this of RESILIA disease year. X significantly and a population.

TAVR improved opportunity in to In this our which to challenges range. of positive assumes range summary, XX%, growth XXXX the at our shared COVID-related We compounded conference. X% consistent sales growth global outlook remain we with that large $XX resource constraints outlook hospital XXXX rate decrease. during a underlying our in double-digit for double the We remain annual confident by in XXXX, low will December implies as investor billion

proudly achieving than to patients XX,XXX care have We repair the progress our and treated achieved Turning transform to Since TMTT. meaningful system. patients significant for milestones with in vision PASCAL made launch, toward more with disease. tricuspid XXXX we mitral and

Following with in the pleased to initiated at approval Initial X-year of outcomes the we the be XXXX. follow-up the feedback presentation of Precision cohort with II Class date. IID in positive, from TCT system U.S. in the clinicians introduction half patients and presented PASCAL and of we're FDA XXX full second the patient Class will been QX, has

our as a ongoing in continue high-quality as Also on launch IIF Class patients expanding Precision aligned bringing new with to advance advancement we PASCAL scientific our commitment pivotal centers. existing latest this focus trial functional mitral our into to evidence with is regurgitation. to the generate Europe, well In centers for enrollment with

of MX of SAPIEN ENCIRCLE expect and the X In mitral enrollment the pivotal The XXXX. complete transfemoral trial on SAPIEN for main the enrollment a French replacement, recapturable dock. end we're valve the platform progress of with sub the making repositionable around good to leverages cohort

to Eos and this MISCEND are early next options. enrollment incorporating prognosis for with mitral patients, study the into an option who be a Eos excellent the generation. platform completed We and early valve experience limited from the Separately, feasibility the have we've has believe treatment poor our in the learnings potential

Shifting the currently studying TR. it Class enrollment pivotal of clinical and are that's TRISCEND the enrolling our studying trial prioritized II replacement study repair, we addresses tricuspid EVOQUE treatment from of of the We TRISCEND study, by the of for advancing evidence, body population of our to that of TRISCEND tricuspid the and suffering II II two enrollment and this and CE trials both first the in strategy systems in have of who II mark track end completion half U.S. options. on and are Evoke is around few large end patients expect XXXX, debilitating year 'XX. we and as approval

bringing meeting presented at PASCAL. follow-up of Class data Precision this to TriCLASP tricuspid London system from trial. clinicians performance the Valves TR In we results of recent PCR TRISCEND study U.S. are the both reported with for and patients, post-market our very tricuspid to clinical the about we're in their our following the EVOQUE favorable patients looking in which differentiated and pleased forward Europe, PASCAL positive therapy very II We're the

sales year million, XXXX, prior expect Turning to up performance Fourth $XXX currency by supported year. quarter basis and of early million million sales of of the U.S. guidance the Precision were the with XX% In PASCAL versus latest the sales TMTT nearly global continued in consistent our in Europe by Full $XX were we on million. constant of sales $XXX the a driven $XXX of PASCAL adoption to TMTT. initiation

leadership. recent lives believe and disease of through milestones We advancing bringing mitral look in diseases transform to patients remain life-threatening our these differentiated valve the to to positions conference. investor therapies with of well our strategy We forward us portfolio the outlined for to our committed this vision patients tricuspid with and

up over increased In XXXX year. year. of the Surgical $XXX basis million, constant sales Structural on the constant a X% X% Fourth currency Heart, were a full versus million sales prior $XXX currency global on global year basis quarter prior

We penetration premium are of regions. challenges the our by increased products see global in strong COVID to despite growth RESILIA encouraged certain driven

staffing surgery concern, to believe hospital we heart that continue prioritized. a was be Although shortages valve

mitral previous benefits portfolio seen have offers And proven We the is adoption of surgeons of ease for greater RESILIA to the potential believe of of designed both replacement technology, We the MITRIS built features procedures. in valve use the facilitate generations globally. valve increased mitral RESILIA MITRIS transcatheter fourth the saw valve U.S. and and value interventions. in and that advanced of quarter. future upon momentum technology this aortic tissue strong surgical We

the confident advanced sales in growth Structural heart demonstrate the summary, the our clinical to tissue earlier XXXX of with We the are by RESILIA full this position. durability initiated most adoption surgeries. this Surgical underlying will that and overall In new our technologies the study this remain in was growing body mitral we growth of Enrollment be mid-single month. Momentis large in evidence digits valve of study of for year our driven Heart,

Fourth year. quarter lines sales Critical a Care on $XXX and on year Turning XX% of constant Full Growth all currency sales HemoSphere X% led the and to of currency Critical increased increased constant contributions prior from year. driven Care. regions a million by basis versus was basis product million Recovery. over Smart global prior $XXX by the

In for our hypotension Demand our algorithm ClearSight portfolio, elevated and sensors Recovery to pressure ICU monitoring in in adoption of FloTrac prediction the RECONNECT the due featuring index our used hospitalizations strong. U.S. unique remains Smart devices

about their at sales investor critical conference, families XXXX. our patients growth technologies highlighted get of our pipeline innovations, discussed and better care home recent As decisions help to clinicians enthusiastic smart recovery designed to make in faster. We by remain

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

and guidance I for Thanks fourth of provide detailed a a year the Today, results for quarter provide quarter wrap-up XXXX, lot, including well as of the XXXX. first Mike. as full will

Mike on disruptions geographies. $X.X of basis, of a our So despite key quarter constant the the as X% a fourth grew our care currency in in number billion health mentioned, sales

FX. earnings the to was gross sales $X.XX. GAAP temporarily inflated excluding disciplined rate margin this per Our per due share of profit growth XX% share Combined in earnings healthy, adjusted spending, growth and was resulted even to $X.XX. with

with disappointed stock opportunistic only poor that were The time more it we was last performance provided performance upside stock year. to to our Obviously, shares an aggressively. the price repurchase

$XXX accelerated program. we share million through quarter, stock an repurchase the During repurchased of fourth

$XXX the fourth And $X.X year. in during fell last to shares we million. of quarter repurchased Average stock total, billion outstanding

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

XX% XXXX, year the generated over grew full cash of share increased sales we flow. the billion. billion constant and earnings currency basis free For to $X prior year on X% nearly $X.X a Adjusted per

with improvement growth a in hospital We expand in XXXX rate sales expect our staffing. gradual to

our year saw year, full in and QX to still the start which range. signals in reinforces a so we Although the good during X% far early about encouraging QX, confidence XX%

$X.X billion, $XXX $X sales to XXXX. $X.X We sales sales million. $XXX are and of billion of critical expect previous sales all Heart $X in million, ranges sales to to of sales $XXX of maintaining FX, moves $XXX our TMTT total guidance company Absent $XXX TAVR for million billion, $XXX to Surgical billion million of we care Structural of million million to big

billion projecting first and of per we're the billion, $X.XX For quarter, share earnings sales $X.XX. adjusted to to of $X.XX $X.XX

Now details our cover I'll of results.

Our against XX% the expected FX period This same the was fourth offset driven the compared gains to in and by the from impact contract which adjusted from in sales improvement and that hedge the includes of quarter our gross negative dollar. positive the impact profit margin last euro the was yen the natural XX.X% hedges year. weakening program

basis margin between rates, exchange versus inflation. of foreign full plus some our continue FX the to we current rates, XXX points from At in year's to gross margin XXXX XXX and year current expect reduction this At benefit profit profit adjusted forecasted exchange be to incremental XXXX reflects gross reduced XX% XX%.

decreased SG&A team $XXX the commercial the or investments the model the partially prior to sales, our euro the million fourth the and the high-touch build-out ongoing to U.S. year over TMTT for XX.X% against TAVR. expenses primarily in by in weakening continued quarter dollar of of X% and offset due yen the and of

to to expect XXXX XX%. year full SG&A as between and sales a XX% of expenses continue We percent be

million, were at expenses development with prior $XXX of and the or consistent year Research quarter in XX.X% sales. the

TAVR XX% between new to TMTT invest expenses to expect continue we XXXX We sales XX% R&D and growth. developing to as generating in evidence be support and technologies in of and

taxes. Turning to

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

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

Foreign million growth percentage reported sales quarter year. or rates compared exchange points fourth decreased by six the $XX to prior

approximately expect full year-over-year foreign now we XXXX sales. exchange flat to from rates, current impact At year

had prior October exchange basis gross the our fourth guidance, minimal our quarter Relative earnings to to fourth Foreign points rates impact XXX margin rates positively share. a on by compared quarter impacted year. FX per

over an our back call flow. the to Mike, and with balance turning I'll finish cash before Finally, sheet update on

$XXX cash, was operating of million. we million, flow maintain to short-term continue defined for with the cash of XXXX, cash flow $XXX $XX from equivalents We approximately a capital to cash quarter the $X.X and as sheet In activities million, expect to cash Free in the billion year. balance grow $X.X less of flow free flexible billion. fourth spending strong and to as billion of $X.X end investments

pass back I'll to And with over that, Mike. the call

covering solid financial you, performance. Thank informational Scott. therapies [indiscernible]

patient-focused expect higher transform our and systems with care worldwide. XXXX and value meaningful improvement hospital. We patients we're health growth in bring a that care -- patients gradual in strategy can serve our We and believe confident innovation to to

that, to I'll With over back call the Mark. turn

Instructions] that, [Operator Thank to Thank ready With we're you, Diego? you, your Mike. Scott. questions. take

Our And comes at Robbie question-and-answer Instructions] JPMorgan. will we question from this our time, Marcus session. conduct [Operator with first

hear Great. And Mike, your before I couldn't ask, remarks we closing before.

little a if microphone I far a know away don't not. or you're So from

Okay.

There are. we

Okay.

don't I in here. the the happy Robbie, she'll we'll I'd and just why proud made line conclusion, significant be delivering conclusion, and we and the you first give of progress I a you second. Thanks, advancing transformational performance. financial patients If new that said, in XXXX therapies solid in be give for like, we're to for

We expect meaningful in higher regions. growth major a across and in with hospital growth staffing improvement gradual all and 'XX progress

believe double systems and XXXX, we patient-focused cardiovascular to can to as Thanks, burden, between value that and transform will and health that largest care and strategy disease global we're the ages innovation And health the worldwide. serve remains population our bring Robbie. care confident patients nearly and patients opportunity the our now

up. back You're

you based those seeing trends on could exactly and the improvements the us more give to quarter, you're you seen in first and what quarter. in guide a the were Maybe on spend time far start, XXXX little talked what you detail trended TAVR some so how what far? improving confidence in throughout so what gives you've of quarter Great. and Maybe about TAVR

get really to not into I'm quarter. the Yes. going deep

a Scott some had that things get where where around some quarter were some see seasonality the positive really quarter, during the We mentioned, the we As weeks saw times normal had we But in investors soft I our we strong. really mind dampen I for quarters our just of holidays. had does of single-digit on we strategy. think not what's of that few growth, that our but enthusiasm if elevate, a certainly the

structural patients. kind are wasn't just COVID affected companies, to heart including that we And COVID there know consequences of global many growth Edwards.

sales all still we to big X% impact of year. growth to it for more In experienced XXXX, just we if So a COVID, that much the was flat and drove and XXXX, sales we 'XX, COVID that although grow pretty grew remain are importantly, in in confident grew Edwards XX%. XX%. tough growth lingering comparisons replay, 'XX, And we X% us. going

strongly heart So treating we COVID's going to the transient that just impact patients and priority. is again is going We feel environment to improve. think structural a become that these is

a as from initial to maybe the a hearing follow-up, what PASCAL feedback into has I'd the you the months so implanters U.S. couple And quarter the gone how first for and in of Great. launch get love hospitals of you're from far? you're

Sure, Yes. take Daveen. question. Robbie. is This that I'll

positive, this launch and the from the improvements we navigation of level, So been a approval Europe. I the right? high received really early know that at in new the people far of think and Pascal system use, feedback precision in love ease physicians has U.S. we

to these kind So we're improve launches. inventory ramping of the

all And I about really the in outcomes. mantra think patient U.S., is our

our high-touch a really gradual getting program. We're training And model. focused really have on so strong we focused outcomes, really introduction are on clinical great

really So, far with to we've date, impressed that. so been

at they'll more positive and obviously, market a more convinced out, in say, overall, would tier I'll be interested think IID that And that using and Precision that we've impact Class the physicians got in finally, PASCAL I have system. the we TCT. think came data And great we're

Our comes Larry next Fargo. Biegelsen from with question Wells

TAVR there's expect Mike, the do trials unload three earlier, you to trials like you about your U.S. follow-up. wanted guys market, high-level among mentioned TRISCEND a How question. opportunities? three asymptomatic, actually moderate 'XX, on of I investors. for tricuspid. for I because start being as potentially rank do growth? you to And EVOQUE have looks to presented lot wanted accelerate it with you early trial the And one these for with a ask Obviously, TAVR next AS, concerns major year have these II I

This TAVR, endpoint. trial X-year a as Related a just early is reminder, that has Larry. to

just X-year end at the completed year. we the So last follow-up of

So we haven't go. to patients year these -- another have

that So they available over data our an so funding TRISCEND, turn study, present I'll that's wouldn't hands. And We out data. for terms it of of be investigators Unload really up is when until provide XXXX. that, Daveen but that's really the in of maybe Bernard. or to to that really IAS kind for

Yes, just comment I'll on a make TRISCEND.

study, expect year the II the second TRISCEND release obviously half information in for the and release So of the year. the we second of the half the information in

about But good feel us the all I XXXX. it. think make help you we this us up data helps So about as to driving into pull we're here, this think and excited then year

-- Yes. Yes, Larry. is again, Mike And positive It's feeling long about off. way just XXXX. a I'll add this we're

prioritized the ahead, heart But mirror soon fades we when to this again. with really into give to are So and COVID that get back it's the structural learns it too point. rearview deal patients the to at system road look think as going we guidance at

going that that pointed our love of anxious indication to our trials are expansion. they're be And we these in of patients. technologies, clinical treat to think lineup lineup We

see -- we outlook. we XXXX why feel in that's that confident And so

UR period, think as maybe certainly strong. to is see, saw QX improving, we evidence mentioned, we just as impact, I And as especially to on around were SAPIEN X staffing gradually Mike just Yes. we in some still launch. And it's we saw fast And not that did holiday add that the really have the want. some weeks that, we but

really we this and or year We about, about things sorry. good -- that we're excited have feel other year, next very

That's helpful.

the an a Alliance missed anything update I I and there? it on XX, follow-up. trial didn't sorry in Safety is there quick hear Just -- if

any No, there. don't Yes. update we have

we to we have we investor in anticipate we clinic don't that. anything still think to said new I add. back what is conference at year, But the expect be this and

from Our Vijay next ISI. question with Evercore Kumar comes

first U.S. think up implies question, the I think mid-single. I mid-singles, trends, Mike, TAVR mid-singles international the for was on TAVR up was overall

impact there well? were were think then happen talk how I So about was international. double noted Was quarter are or maybe in any half U.S. call, you Or thinking that digits, on this saw you would centers that the TAVR you trend And here? the a half the progression flattish. China last as in up

get about I'll and Yes. a then Larry talk OUS deeper in the can little U.S. little a bit

Europe experienced the thought, and Japan, worse than the we was of U.S., than the as better of, outside and So we that we world procedures In we Europe even QX, you was grew grew as in outside thought. U.S. digits. mid-single resulted challenges in faster. and sort some digit will, the rest Japan if it And mentioned, mid-single expected, the of in

of that's that out. way of things kind So netted sort the

We regions growth 'XX expect the are as to from rate. XX% in all projecting better be we to X% that contributions

differentiate U.S? question what to other was Your was different in trying the

saw double there this Sorry, quarter quarter. centers up as you were last a trend think, that I half Was well? the digits,

a localized restrictions. kind I it think significant saw basis. of site-to-site on We centers, variation Yes. maybe Clearly, and some COVID reflects

the certainly centers a centers. see than But better improving did bit over than other And gradually, smaller time. little we did better probably that centers. Some centers larger

way on had a but such driver one was the business, It's You small a certainly other. question our base. well. a or TAVR not China for as China impacted, it's huge

helpful, And Scott, a X That's for quick Larry. maybe you.

assumptions organic, XX% Or single, double we what's to about QX? midpoint talk here guidance sequential acceleration improved? it's in visibility from organic low high I saw the QX organic driving the high the -- think at singles the think Has I QX? close just at almost, around hinting

it so far range. on is sales the $X.XXX the of guidance at to Well, you is for it ties underlying midpoint sales. the going so XX% call, about to how million, the $X,XXX about call the billion of for guidance to talking Which year what just $X,XXX QX sort been is we've in given to at the lower we've of if out X% that play end think growth rate our

QX staffing health happened and is And investor hospital it's back disruptions question really favorable very getting and environment, talked our growth what your little a ties levels QX about bit So and at reinforces similar better. care the we're for seeing about can between to year our gradually we just to to a it conference rate achieve we the full and what that X% confidence XX% in XXXX. generally

Our move Jefferies. next to comes question Taylor next the from with Matt We'll on question.

Our with next comes from question Matt Miksic Barclays.

So I'll one to it keep question.

your of towards improvements Just I talked maybe some end QX. about, see trends early some comments year, Scott, the around comments in gradual you the encouraging on of think this to starting that

trend. things a you're you bring about slower. confusion that double have are Given around sort the seeing point centers and been this sort of you TAVR staffing of What of some Can the talk and these being encouraging having maybe trends availability encouragement? about nurses talked gives being things sort of impact you out of few around better? as that sort on many things digits this getting potentially of slowing to Which U.S. you that some that

trends are hospital the the in hear better disruptions favorable. what track. overall the abating just that we're anecdotes the U.S. care weeks getting with are we expected with generally on this Well, But the us is tough that it's And in happen different like staffing we to just confidence the a of bit good health in right XXXX going that question. year. of first a and elements the outside of multiple into see to all speaking, couple overall, that And the it and isolate we system, give U.S. It's the constraints little seems signals

in wouldn't $XX.XX guidance And pretty XX% but we in say, to quarter. X% given growth to January, the rate it's the signals January $XX.XX looking that we've sales guidance for the first to range XXXX. are seen for early that we've to obviously, in that reflected the again,

question next Joanne with Wuensch Our from Citibank. comes

looks think Can I cropping of we second guide getting gross the up better. XX% it of lists hedges. we over us you two things the in the walk -- just couple different your you is sounds fourth it straight like sort line in seeing quarters, FX of reversal ones. that? It should have question, have quick you 'XX about like Are for quarter, your should margin then down next places? how the And wait are through

Why don't the first in somebody take else then jump question. I wait and let list I'll the piece, on

Just get little moving pieces. in bit get a margin, are in efficiency of improve I little global we from of We of simple. have the terms of it's activities of benefit mean pretty a there bunch little always to a gross from supply bit benefit mix. We all chain.

source given all gross that's and us that contracts hedge of But U.S. XXXX FX we XXXX versus margins. with year from outside gross of well both really, is and the FX. valuations the hits as as the XXXX the difference we've XXXX of guidance inventory between to for decline the margin quarter in the the fourth full have XXXX the And really

question, great backlog on analytics don't have as before, we've backlogs. the Joanne, mentioned we on And

lot we it do other what for from say, a just matter. here And there and across we customers. U.S. so anecdotally But of is and yes, countries the hear spotty that backlog indeed, that's

with Chris next comes Our question Nephron. from Pasquale

that still as idea to depleted the population you in the you excess could the pool view go see capacity? headwinds talked as you hospital than to do much have that staffing. might normalize take U.S. back I and patient that bottom about your like of it what investors that with one is think mortality a Do simpler haven't to really significant I something issue guys that, COVID-related funnel concerns your hypothesis longer factor? the that's Mike, a in bit wanted little Or a and

Yes.

a has highest pool. said very Just environment don't pool. small There we it's sadly, in. know the serious of that big goes isn't level, patients, consequence that They And to on. that's be true. some mortality we're that, at really a the these a really, Having that, for this It's just wait well.

And putting treated. number use the their this from comes severe a sad to that close not through really having that could help AS the so dent is mortality legitimately in patients even of

That's line while have have just those you Okay. I of one and T Any Class and of then And completing for been helpful. guys on sight a provided time on a I don't line mitral. think studies enrollment going there. into

Yes.

this is Daveen. So

So a TR II I'll Class about little separately. I'll follow talk on first IIF up bit and

our actually is TRs, important, remember, know and But we tricuspid of So patients. more people. in believe is that population this has prioritization, Class think be really to that we first, large for to we tricuspid important we potential that diverse you the tier a II on EVOQUE while think

of So we've got to options. have a portfolio

So two have we were our of as -- the TRISCEND well Class the clinical PASCAL. trials for pivotal studies, sites of II EVOQUE many II both that as different TR sites, obviously, to And actually committed especially many the in are these for U.S. running actually at site.

enrollment So fastest. sites did prioritize we that TRISCEND II to drive actually what actually we is ask and

to XXXX, kind here on enrollment before. kind as we've of of of about first complete in that's the so And track half talked

in hopefully, kind Class to finishes we'll drive So up, of up. trial enrollment then in of enrollment we're that II then sites asking see pick now that TR as kind

functional on kind moving our randomized a right, IIF, to trial And Class of trial.

And right shared for sites a sites really is or IIF. trial commercialization a We Class that in of mitral, the that. enrolling on in Class expectation yet again, again, other IID approval that actually of kind That It's kind us. also were the are also lot important trial haven't of now. were yet for

our helped in kind guys, did to you well," now really switch Class approval. we've Class IID let's as drive And to initially enrollment really they them asked the imagine, And "Hey, again of we their said, which prioritization and drive sites IIF.

of in kind trial now. see trial, we is So of a XXX-person trial, that the again, it's which a enrollment larger enrolling kind right

So an trials. two of on that's those kind update

Cecila Our next question Stanley. Morgan with comes from Furlong

if as following could about you more funnel as the ask and How us like strategy thinking low-risk there, as talk think impact just then additional bit cadence strategy question you about a -- to 'XX about pricing rollout, to well TAVR in in the I wanted your Japan. It and from a follow-up coming sounded too? you're patients on patients, RESILIA just into there a pressure. in

the to then had been earlier setback is I'll and Maybe complete lot this thought. for that real restrictions. the Japan wave system. that that a that with of system years and was few rate deals the in the health year. But our even And for when a others sort to the turn growth it for way of start a over care Larry came he it with to past COVID can lift QX, of through Japan Japanese it out implement really

pretty And in expected. so that some into we big It in that impact really even than QX was more dramatic had QX, and continued QX.

in better much Japan. is situation The

very we of see so a improvement XXXX. And solid, substantial the course during

forward. real a to expect to So we Japan growth Larry? contributor be going

We can't hear Larry.

Sorry, can okay you me now? hear

Yes, go ahead.

Okay.

the a excited Japan. there's in about things So -- lot be of to

-- coming begin a right probably In approval probably big the Low-risk talked Ultra for is Mike before TAVR-in-TAVR, to out. a recently which thing. for also rolling QX, in approval RESILIA We have the that's Japan. recovery we'll that thing addition broadly, do got is that big more SX then about we

looking So historic growth to the we're recover get of more them to back really rates. for and

to follow can could how center speak at up you just and the adoption I U.S., this centers RESILIA at just point, strategy point, if you your talked over And QX in next XX% interest about of think converting the few in about penetration this cadence you the but Great. quarters? to

Sure. Yes.

Remember, the so has how launch with than pleased far. this really anticipated. we earlier we're gone came So approval

built felt inventory to build as of had we it out. up So we and ton it that roll so we a inventory, up like had

plan So continue we rollout good we're it's outcome the with year. expect entire has through be, happy we And pretty But we're and us. so been to I where positive. think the physician think, for to right we The much far. feedback

than price We're also technology. innovation bring which increase, the that It's we've has X%, we think the -- it increase which in a for RESILIA but with less and It's done we that is years. over launch, XX value pretty price the since going first modest. the reflects been

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

FX. A and quick clarification was on

I better. the was think million stayed revenue but the $XXX FX same, guidance

looks U.S. question that? It's like then down versus I on it Just the to TAVR. And moving but tell U.S. TAVR was on parts wanted exactly, to the also sure hard was understood make QX.

X% to then it sequentially QX range? that in And down up year-over-year weren't don't to of grow headwinds I in know and in QX think that can and if maybe kind in anything XX% how if call U.S., QX was still to specific So QX? the there's actually versus about be QX in that

Sure.

a you're we flat. currency million upon do originally will sales it yes, There think year. be averages the sales in to question tailwind recent in it's there flat first will half right. We half. to the about to of the based out be FX, XXXX, anticipated think the second now but $XXX We to for full on sales headwind about a headwind moves, first So about

though. stays rates the If

At rate. the current

TAVR growth Regarding the over in TAVR, expecting QX, we're no, U.S. and in growth QX there QX. in more over was actual

global U.S. sequential we're and TAVR. TAVR seeing growth growth So in year-over-year and expansion

I'll Great. Okay. SAPIEN then recheck X on And that. the RESILIA. on model

the a getting on little Because think launch. versus Curious price? pricing. uplift stable it's you're of bit You volume the how actually the assuming price gone discounts, all guidance is color mentioned I like

maybe want just impact this to pricing think make I'm about I XXXX? pricing more year sure to the in how and on comes clear So

Yes.

we built price about ends increase goes have. and going going the it's were $X,XXX we for are are SAPIEN pricing price increase whether volume we X we're SAPIEN are or but valve net a is So X a What X for Again, increase board. UR those it's going whether going that for on with board. the pricing happening less X%, was pricing and than across every we up, rebates it but that UR across have as we a SAPIEN in, for up

Jennings with Cowen. Our next Josh from comes question

XQ? I out. want better get surgical clip higher you the heart understanding to the to then to to in for you just that grew understand have than surgeries wanted franchise that Do just valve of a start called expect prioritization -- valve versus this business And continue with I just a a the beneficial in TAVR X volume quarter. and And fourth growth follow-up. price some be It maybe maybe on business. the question on at surgical

out and TAVR my require here. to I'll mean start then surgical I they overall, buddy same patients me if with thing have rent Sure. don't as trouble Well, to call up patients. the But a the work on is help amount of

can the such much sizing surgeon that's faster be for to there's just and been CT patients. the done intraprocedural has they So because that valve workup system move they don't for the as for so where require through those things

So maybe it's a little impacted. less

there's how over think those a urgency well. patient quicker. continues the is in move system can also open I We'll side that, a surgery, and But to surgical mindset bit heart see drive a as we continue little through RESILIA just that when more needs that that time. on patients the

continue We with have the side MITRIS which I INSPIRIS continue. add, and if launch, well as going, advance aortic is RESILIA we Daveen. to know anything on have those the and to don't you

really departments. parts, a patients kind resources in prioritized really surgeries, generally hospitals. see bit valve surgery the moving to Yes. make Larry help The is surgery surgery that, start these from I'll people important We other that if chain of cardiac comment resources other see being within of acuity heart talk in they're as about said, other high we short only food we

So you see keep surgery has cardiac overall. little its moving, volumes helped of a think actually resource bit which I

complex picture, right, at is the these we we continue also need grow, surgery. is that going going always same to in That aortic and valve to always being there'll market increase TAVR the AVR to with replacement. time, expect, be said, patients macro expect disease But the that

thinking aortic total And in patients States. in percentage and the but just bucket a TAVR the the term, of severe early United follow-up very severe stenosis results about stenosis on just aortic not near are the the asymptomatic

You estimates I that understand could of XX% guys of is new better lower? or of in total, have total unlock? to kind TAVR XX% wanted a of any terms what just early

at. question this so on terms topic, there's that's it's and say the for that there is of bit literature There's or lot that there's how patient, not difficult on great symptomatic a lower. There's Yes, this probably over end. in because that says studies of looked it asymptomatic asymptomatic an a all studies studies a -- the gets on it's probably the patient, out higher little for every place every other

are necessarily you up. weeks but fine, through bigger they I picked regardless, significant, the flow the I system patients feels because patients and doctor how ago, feeling? is maybe two think here doesn't But And come issue struggling think that it the were but how patient that and the it's get impacts day says,

symptom the severe that your says I think take assertation AS, we and you to for the if of equation could out move therapy. echo have you if directly just patients

just the would it patients game be think through I changer a for how system. flow

we change follow patients of significant really asymptomatic, treated. a it's that opportunity of happens are definitive it's the we these think you data to trial, we how echo is the took what reasons one what stress you people, but that's And purpose have we on the happens to really the EARLY aortic need TAVR shows think and when that really when stenosis is

Maeder with Sandler. comes question Adam from Piper next Our

Edwards up the notable market, space an clinical call of a if And first think tricuspid transcatheter study anything of from which coming the TRILUMINATE. replacement? both couple terms is that study The question and ACC, wondering in potentially then one out there's with standpoint on weeks. in repair there's in you is had a Do tricuspid data. I'm And I competitor that follow-up. could catalyze then you'd

this positive around Yes, to To and little We opportunity gets actually patient amazing wouldn't ACC -- trial, surprised Daveen. I'll more this is opportunity would be by the study. great specifically treatment. and shows ACC. TRILUMINATE for be or continue the have bit to results an better approved a me, obviously, hit and data if the on tricuspid patients TRILUMINATE get

are actually it very the about see we and seem said, there PASCAL that Precision being our that actually clinicians of device But tricuspid Europe right for positive like in patients. really performance to now differentiated

care. that technology So we we helping obviously, U.S. to overall, to think look that data obviously the the to the for forward is future. patient But therapy bring in more

that be us And close level, chance don't It's a customers. force. real to ACC time. full trials have to for groundbreaking But be introduced then we'll that in at to going any are a we at high be

Okay. I But adjacency. allocation. structural think interest potential remain on And recently actually follow-up. also capital. a you're One going talked new to a clearly, then you've having for quick heart. just focused within And in about

you referring some to investments shunt heart I and failure, And you atrial also have have external assets. program, an think internal in

when forward? more about these should expect the here learn path we initiatives just So broader to and

investors out. been Adam. end therapies transformative until taken these We that, for have risk has these are the about uncertainty. also potential, Thanks early like big feel program. to some the with talking it at have share more big Yes. that they stages, the we of At up big appropriate but we more And stage when of have don't it's risk these early pretty

So trials. like for already human we're in example,

big applied to So something cost We very really really, that likely Edwards health of reasons, about priority for is the that's it mortality not well and this burden patients for our sets both. to but company. much kind we're be this and skill talk has competitive could #X think that's a care of the group

Operator

Securities. with question Richard Truist Our Newitter comes from next

But growth, TAVR international visibility staffing in it seems out COVID parse the more U.S. like XQ. into hoping for surge gradual. U.S. international, the a around more in a cadence more improvement quarter-over-quarter expectation little And little color hospital bit turning there. feels tide just to expectation more kind three for I'm on the U.S. versus of thank you of maybe the the impacted

that us a And acceleration the then little keep pieces in bit And more correct? of bit right is it? the Is in about half good think first visibility? half? it in your an that the way right back maybe recovery more it's the part do think acceleration and we and the U.S. gradual A, have to for of around be perhaps little a internationally first a XQ and do the and year to for you modeling faster

globally. on about to first, globally. something the through QX sequential U.S., true said globally. I U.S. back growth XXXX, XXXX, in and growth. Rick, was asked QX and there Travis sequential and So I to growth QX want before. sequential are it QX go the to

X% pin of U.S. full relates tough it XXXX contributions chime expecting U.S. which We're we that grow in that others regions both going growth XX% to from contributions are the exactly in As year then all and 'XX. going outside what regions down in. It's But the underlying and our get I'll we're to to think to start major of to rates. to the

should and the That's lower or recent aftermath biggest what's we Japan, here right. been I with that it's they of mean than in three if we be at the U.S. they've the they've happened throughout whether on past, just look or regions, Europe COVID, what the XXXX. expect our that had based improve struggles to

like but I you're it's feels together? or of -- staffing. impacts in the less expect The to visibility you better better move versus you not all factors. guess more Okay. two have COVID hospital like areas them your into Germany there surge It visibility saying Japan, challenge in and

to say environment close centers. center-by-center Yes. have to would visibility just the feel happening them. we we that basis. will our close like And We're I and very on our improve. very a we to we all of continue feel customers, and know has similar what's on

of a your are least know centers? BJ's it's half half And U.S. centers still doing level at cohort Okay. your or of growth that see from in I still following question. but double-digit just to variant, you the up growth do of

doing section But it's happen. certainly, that centers see not are exactly down large COVID, to restrictions know that so again, of Yes. large or pin still a we I if COVID growth. I it don't double-digit I but And could the a our a think portion much it's percentage.

And the restrictions of sooner. country been release parts those I where have the think

better. to is think along. mean XXXX. I doing we I we the that things those the the centers you those come one see what I really But globe, restrictions are look us easing think if helps rest expect and across of broadly, that's in

that feel add and significant where us be good out saw you during might the there you though some volume, Larry, some And weeks about fact there some must right? was there, capacity made Yes. QX that

our in QX. weeks the Yes. biggest that some had of We we've had history in

to weeks the is the for able staffing doesn't but that indicates several system, it's a XXXX. that were year, us fact guidance things our better do capacity they into week back coming a one the getting and for that in So and make of it confidence is gives

turn concludes remarks. management for our that And to the today. floor session back you. I'll for Thank closing question-and-answer

all welcome continued thanks in Okay. that, interest Scott, questions any for participating. I And additional for telephone. Well, Edwards. by thanks your with Mark and

day. All a great parties may concludes you. conference. Have today's Thank That disconnect.