EW - Earnings call transcript Q2 2019 | Edwards Lifesciences Corporation

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Operator

Greetings and welcome to the Edwards Lifesciences Second Quarter 2019 Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to Mark Wilterding, Vice President, Investor Relations. you. Thank begin. Please

Mark Wilterding

Good today. Raya. thank for you Thank afternoon us joining you, and

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

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

Mike today's Chief Chairman Executive Financial Officer; presenters on Mussallem, Chief Our and Officer. call are and Scott Ullem,

on today's begin, statements guidance call, growth to limited that assumptions based management that and trials, clinical be like remind aren't Before regulatory reimbursement, I'd opportunities, These during we and projections. competitive foreign forward-looking will making are but longer-term statements matters estimates, and fluctuations. you currency approvals, litigation, expectations include, for financial to

which These obligation statements they undertake does update and to speak any not Edwards only made as on after date are today. them of the

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

is measures, GAAP terms that to reminder a adjusted, Finally, otherwise financial quick underlying and non-GAAP they management results. are when to using referring referring

edwards.com. information non-GAAP use today's measures at of and about available the press Additional is included release in

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

Mike Mussallem

team. the to welcome and Mark, you, Thank

in by a billion of strong global second lines. across underlying projection in product to high $X total all We XX% strength by XXXX. sales a opportunity our which $X.X reinforces growth were report are balanced representing lifted teens Sales belief TAVR, sales with our pleased quarter adjusted of growth billion, four

and the turn aggressively to technologies breakthrough patients significant even an continue We broader drive future group of potential to value. in with help pursue

have that will Given performance, double-digit XXXX. half again our growth in we achieve confidence first increased we sales

million, growth. anticipated we up quarter stable results were price XX% Globally, remained second global selling replacement after growth our first basis. accelerate discipline. exercise transcatheter continued this We estimate would quarter procedure on or TAVR exceeded to We as valve global underlying growth TAVR, price average our quarter our with aortic expectations. our an $XXX and sales the In comparable was

half we our global in For the first investor estimate with December procedures the conference. grew XXXX, from of TAVR consistent the guidance mid-teens

We TAVR sales based across teens our US, centers. confidence by and share in QX. our increased stimulated growth PARTNER X was and following the encouraging high results strong the published that in note In presented stable. and was in we was the the low believe grew of high clinical procedures that late broad estimate growth was therapy to volume both It

protocol the based patients patients now TAVR at would on X to to approve our sites. and our in are high surgical in based who X will on referral trial referred improve not be on the the from and help are the treated diagnosed, risk quarter, than medical access continued SAPIEN XX treated SAPIEN We more Ultra Patients low risk. with that for continuing third clinical volume patients X FDA guidelines. PARTNER estimate or low receive diagnosis, continued they increasingly are many benefit that are efforts Nevertheless, increase who patterns there confident research, care We that we and today. need and remain focused awareness

We Late on thoughtful commend better updated final released Services believe or in Medicare we CMS toward updating and NCD, the needs the & of CMS the Medicaid the patients. its US today's which practices for approach QX, TAVR reflects Centers policy.

requirements stenosis. evaluation access we and should meaningful did patients aortic for from believe more streamlined the the equipoise patient not improve suffering surgery more enhancements between severe TAVR, While achieve are NCD process modernized and that

procedures mid-teens grew TAVR Outside the on with growth estimate comparable. year-over-year basis a US, in in the Edwards’ we the total second being quarter,

TAVR remains In year-over-year opportunities continuing of expect on SAPIEN We international believe excellent TAVR a adoption by of as We're majority continue for low. our see Edwards’ launch the sales grow growth, Europe, which in Europe, quite OUS procedures we our for system Ultra in mid-teens also we therapy in to estimate account growth was to and basis TAVR of comparable. we year-end. that a Europe X

our to adoption -- an meaningfully the qualified. new being elderly throughout see that by are undertreated limited limited a focused SAPIEN In driven to did of X we remains contribute driven was population. aortic strong along a remain and in by not was belief Japan, this stenosis We large disease expanding country, centers immensely TAVR on TAVR number growth. therapy of centers and the CENTERA availability continue this

discussed a SAPIEN landmark believe superiority prior X year, population. clinical we risk of a best-in-class patients ideally demonstrated evidence, PARTNER surgery low-risk platform. earlier this one Edwards’ aortic trial with robust low As X with SAPIEN over or year. great stroke in the A Combined with at X we stenosis death was X% of clearly patient majority are highlight of treated the

for at and CENTERA we balloon-expandable our discontinue and made pending to platform, approval risk of the have program. low patients difficult the the versatility Given excellence the decision continued

to is SAPIEN required for to and expanding as CENTERA time performing deliverability the valve demonstrated resources max well clinical While significant. patients, has well are excellent optimize as indications and X the outcomes the

indication best pipeline patients’ believe robust forward, next-generation needs and technologies address of Going by resources focusing we expansion our trials. balloon-expandable we on

also to incorporate preference the delivery and X the SAPIEN confidence we're throughout been the SAPIEN expressed feedback. our working those Ultra to clinician X pleased and be system. aspects continue We reinforced Ultra X a SAPIEN clinicians system valve for the positive optimize changes to by performance, has discipline of launch, with Many have

to expect continue around X SAPIEN physicians X to the We from transition to system SAPIEN world. Ultra

growth guidance our raising in are top year around XX% was TAVR full In to range. summary, our previous the and end underlying XX% year-to-date our sales to we of XX%

long-term quarter strengthen the made strategy. in a resulted decisions these charge, our decisions in execution strategic Although of special we the the

TAVR that robust to strong believe remains position. that our continue and are TAVR the opportunity We will innovations our sustain global leadership encouraged

training, revenue quarter we $X In lifted of Therapies early global Turning the Mitral TMTT, the our commercial Europe. our a or and was as great remained rollout for on experience, physician therapy. focused feedback of that with differentiated positive as to Transcatheter in PASCAL as continued procedural and well physician million receiving progress PASCAL second Tricuspid pleased We're success outcomes patients. we're by regarding

and commercially Cardioband there We to we and continued with also our treated manufacturing been Edwards’ in production tricuspid have supply reduction sites. improvement annular patients therapies transferring as mitral other

mitral data remain experienced patients MR by We're as reduction the evidence. statistically and quality CLASP clinical of data our from tricuspid well significant system. capability in advance we on functional We improvements on developing with PASCAL at as the and the and clinically experience TVT encouraged life. of At portfolio, our six focused medical As the we EuroPCR and PASCAL Cardioband and comprehensive presented recently positive status, study substantial months, meetings. exercise

Looking degenerative to ahead in in approval plan or IID continue IIF announced, patients with PASCAL primary functional we for CLASP or mitral mitral XXXX receive initiate in to to our mitral trial study repair, previously secondary enrollment we trial of and pivotal enroll valve pivotal our disease. late as in valve CLASP disease and

initiate on feasibility XXXX. suffering experience of we with the pivotal of PASCAL SAPIEN significant pivotal ongoing through patients Cardioband experience our US the late In tricuspid can track in both treat from repair, tricuspid initiate with studies in SAPIEN early late Cardioband a pivotal tricuspid a transseptal tricuspid In trial significant PASCAL, PASCAL therapies that and trial our and US position FORMA. for plan number we've a using EVOQUE and we're clinical Cardioband three plan initiate further feasibility in to to in of this MX optimization We MX pleased year mitral trial and We study to regurgitation remain supporting transcatheter valve believe second the a replacement, portfolio. gained simultaneous and future. early

we programs. outcomes acceleration while positive for to the the work have on Further, made we've tricuspid been FORMA with patients other support treated of who've experienced to discontinue FORMA, decision clinical

trials transcatheter mitral disease in to We well regarding at can to with the our our XXXX expect from initiate upcoming on updates hear pivotal Overall, data remain study we as medical TCT XXXX. about CLASP patients CLASP trial more suffering late treat achieve opportunities one-year enrollment remain continued including And tricuspid the IID enthusiastic planning therapies. to milestones, to our and you pivotal our three additional track as by meeting.

In of summary, we million total approximately remain $XX TMTT confident XXXX. achieving in for revenue

and to TMTT estimate continue are passionate approximately billion to global in for of a XXXX patients by bringing solutions about portfolio reach We need. $X opportunity the

particular was This sales and regions offset with TAVR surgical Of in high adoption Structural RESILIA were Heart, usage the all the X% Growth note, strength of was for the up an basis. premium a In otherwise or INSPIRIS on $XXX continued technologies million mechanical aortic valve lower by value adoption US heart quarter aortic procedures get the lifted in outside patients valve to active by valve. as US. grow expanded. increased who more underlying our Surgical might partially in notable

for faster Harpoon now versus in timing previous earlier degenerative guided valve about commercially the what Europe. therapy repair believe late a is mitral unique of patients. and Europe available more echo mitral delay an recovery generally we offer XXXX providing and in Separately, expectation our disease, anticipate will in launch. reflects environment in system, believe heart valve our therapy, a slower We we that this consistent enthusiastic be beating it mid-XXXX remain for The for outcomes while regulatory will that potential treatment

Surgical in X% full We Structural for about X%. comfortable provide innovative leadership of in Structural growth remain to premium our our extend and summary, to underlying global patients Heart, options our treatment with surgical Surgical remain technologies. to sales Heart ability more In range we year excited

FloTrac Hypotension a In XXXX as underlying by our Critical sales Index and boosted primarily patient's software. lines performance, million predictive Europe. hemodynamic This platform, clarity monitoring market All all-in-one X% growth Care, full is a includes an in product important provide basis. $XXX US decision-making. algorithm to sensor and the improve is of quarter Acumen the and our grew contributed that platform on while launch and to on greater in our to were an the HemoSphere designed driver introducing HemoSphere, status, the this sales platform with for recent

million underway monitoring offering CASMED FORE-SIGHT of analytics we leadership create on in $X CASMED's acquisition April, HemoSphere monitoring. will FORE-SIGHT, Sales a enable a technology. the recovery oximetry This integration in our unique of were predictive use our quarter, to smart further platform. the completed of non-invasive enhanced to our is and strengthen combination In tools successfully cerebral of capabilities

launches, sales to X% of X% full XX%, expect In summary, HemoSphere to given strong previous performance projection. the from increase momentum sales year an first and the our growth underlying the now we half recent X% XXXX versus

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

Scott Ullem

Mike. [indiscernible]

quarter growth evidence sales, this benefited performance line outstanding from was of top product sales recent the likely strong this clinical lines our across which with supporting strength four reflecting our XX.X%, Particularly in Our all X quarter regions. SAPIEN therapy. underlying of TAVR all was

Our strong sales the our adjusted and heart of share primarily quarter $X.XX per spending, performance, and partially our higher in the programs. second prior research was transcatheter development grew year XX% by in by structural over driven earnings offset

previously to valve discussed, in with aortic transcatheter GAAP made quarter, share between inventory. share This charge finished of earnings Mike this As we release. strategic million reduced resulted portfolio, adjusted included our per with combined and earnings is A our reconciliation regarding charge a today's per other primarily our special adjustments full comprised $XX which goods $X.XX. GAAP decisions

our of details the guidance results XXXX. then for cover now quarter discuss second and I'll

mix, was investments quarter, compared foreign by last the primarily favorable adjusted by same year. to chain exchange improvement offset margin impacts XX.X% expansion. in period in gross the partially XX.X% from the driven our product supply global was For profit and our This

We exchange to foreign continue benefit our although, year to lower anticipated than profit XX% expect gross XXXX and we adjusted are at our originally be between investor expecting conference. full a XX%, margin from

in XX.X% dollar. heart driven general personnel million by the expanding structural quarter field organization the administrative partially and of over was by second field including the This $XXX year strengthening of Selling, expenses, TMTT related in the sales. increase Europe, were expenses the offset transcatheter prior or XX%

excluding to be to SG&A, We expect continue year of sales for special the between XX% and items full XX% XXXX.

significant including over XX% XX.X% and to in clinical grew PASCAL primarily in result for million transcatheter $XXX of was sales. investments increase the prior programs, The or heart increase structural Research development our the year expenses the system. research an in quarter of the

XXXX, to year we research and full be items, expect development, sales. For XX% the continue special between XX% and to of excluding

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

excluding XX% year We benefit rate, items, continue XX%, continuing to expect accounting be stock-based of reflects our employee to the compensation. tax which for and between special full XXXX

second Foreign compared continue year. to to rates, or estimate million year. $XX decreased current full growth prior negative exchange year to rates X% sales $XX compared about we sales by X.X% an or XXXX prior approximately million quarter to approximate the At the impact

points exchange April to positively gross our quarter reflecting had year. impacted $X.XX prior rates basis by the our rates compared XXX Foreign Relative currency our effective profit second guidance, per impact on earnings margin hedging program. share, to less than FX

implementing year second capital was operating cash spending free $XX of as million with in defined adjusted capital quarter activities to global robustness to expect increase the of We million We million, for million, $XXX chain. our capacity flow XXXX less to and track flow strategy $XXX flow on our cash $XXX from our supply projects remain around cash $XXX now million. full the Free increase be line the of global expansion top in guidance. of

compensation, the in X.X balance XXX quarter our of At million. equity-based during the to quarter we to Consistent prior for plans second million. at cash, had $XXX shares Edwards was Turning and sheet. outstanding million short-term of level debt cash with from shares $XXX the investments million. dilution the Total $XXX the quarter offset remained repurchased million. equivalents quarter, company's the with Average second end

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

in confidence expectations our financial for performance, XXXX our guidance, in performance we increased XXXX. Turning our first have achieving strong half to given

We for bottom TAVR. end ranges and guidance the sales are Edwards our increasing of for

our XX% billion range. X% growth we For $X.X expect of total previous underlying around now an billion, Edwards, to $X.X top to sales the end

now For $X.X we to expect TAVR, $X.X billion. billion

including million to to expect We Surgical continue million now approximately to $XXX around Critical of Structural million. million our We range. $XXX end $XX Heart sales, the and million expect sales $XXX top CASMED, of TMTT sales of $XXX Care previous

earnings are $X.XX. to previous $X.XX $X.XX We to raising year our from to range our adjusted share of guidance $X.XX, up per full guidance

per $X.XX. For current be adjusted sales XXXX, project total the exchange $X.XX between our and $X.XX billion earnings third share quarter billion lowest of at to rates, of and to quarter, we foreign seasonally $X.XX

And back Mike. with it pass that, I'll to

Mike Mussallem

Thanks, first with Scott. strong the of our performance We're very pleased half in XXXX.

the evidence, benefits about As understand of as technologies patients growth substantial supported optimistic compelling remain body long-term and significant of transcatheter-based increasingly ever the by clinicians the we as opportunity.

combined a us with product robust positions foundation leadership, for well Our of pipeline, continued success.

I'll that, with back it And turn over to Mark.

Mark Wilterding

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

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

Operator

America. Bob [Operator from first of Hopkins Instructions] Our comes with of the Bank question line

Bob Hopkins

on in other actually acceleration? Congrats How was is versus just much on think low comment a quarter, phenomenal growth do you for question drove what TAVR guess the the I market. the you risk second for first that acceleration and quarter. some driver? the both yourselves and obvious on Can really that

Mike Mussallem

recent contributed certainly past in I'll been QX QX There factors to probably growth isolate the quarter remind variability the not been that growth lower the quarter. quarter high and there Recall to was pretty higher. each TAVR. just and than has here were hard second it's for multiple in you, the rate past in the uncommon one. to It was has us

have the in there seasonality You associated was been was look with but and it at total it. the between back first quarters a XX% quite difference some around half and mid-teens, it in could

encouraged that increased that. what in was have confidence treatment. the just growth by It borderline had of we publicity results. and clinical even receive we was lower encouraged and volume But to that the mean, lot There the could both that there's trial following been in centers. X might that large growth the PARTNER strong fair, There are more have was the a and increase was that globally believe based It's But minor patients to across by cap. therapy, some that and add US, could the Bob, stimulated it broad have several globe possible particular, in to I be awareness a TAVR. was influences.

Bob Hopkins

I one ask mitral. just wanted just to as on follow-up

XX guiding approximately You're still to million.

revenue the to almost need half. You triple in back your

bit talk what So a just -- half can gives in little you PASCAL about Mike much the confidence year? as that of you you're accelerate the back as expecting can the

Mike Mussallem

Yeah.

the focused really on we quarter. So weren't this numbers

in on The of focused just actually training, achieving and with in of on $XX some the increase commercial possible consumed QX PASCAL over the QX gotten experience, that we confident trying patients. quite get pleased that kind remain procedural we've was for Our million we're feedback success early did it's we outcomes to But a and great sales procedures guidance. actually stayed QX. and physician the bit just

Operator

next Lewis David of line Our question comes from Stanley. with the Morgan

David Lewis

just about saw that's the it's growth second from two of the Just stable, for a Mike, TAVR pretty back we half year, from the me. what frankly quarter. perspective in guidance thinking

is think we then NCD? should expect expect an quick sort of Why approval So follow-up. or inflection should how do a after further that about we business? And the the that not you

Mike Mussallem

exactly. it I'm I not sure, followed

You're shouldn't Is the saying, David? that it be why question more.

David Lewis

your half quarter. the the of range is half means of top second back back consistent year end Growth with rates, the

the why see expect not inflection we not question So NCD? until is, or approval you see that do the do further or

Mike Mussallem

think we Yeah, it's premature.

that Scientific we've won't the to launching so of that process to the have that driver growth. decided As Boston is be of some and in CENTERA expect discontinue aware we a you're here, program, know impact. well We

be going are some those headwinds. So to

good about David. where we pretty feel we And so things, guided

David Lewis

new debate year. just this was then big a And Mike competition

any share the a to second suggested how second entrant, entrants? new you third new year stable And should Thanks impact relative so we there quarter quarter. the of Was in in competition from about think US this So half the from the much. entrants?

Mike Mussallem

us growth, in we market growth assume the procedures but was quite estimate that difficult that always for comparable. It's to growth overall and we -- our

that focusing get months. our it that confident executing to on expect As disciplined coming in and it they're they're active we But remain and the relates launch to appears Boston, in more a guidance. training we them

Operator

ISI. will the with Vijay Our Evercore question Kumar come next line of from

Vijay Kumar

XXX that, TAVR to Congrats versus Mike, just back I on just on we sequentially, a had really quarter XQ. the understand back points for nice half. of here. guidance want acceleration basis

like comps This on easier. just based, comments, your not broad it not And phenomenon. this Your US did was was a based seem right? was

You saw this across the geographies.

comments Your the it first mid-teens think Europe, back back approval to, why the this strong, right? seen the was that's XQ in is on shouldn't the approval, accelerating, we've Europe guess, to I And guys a time being post while. before holding I all happening so you accelerate question, half? So in formal back the

Mike Mussallem

out understand can out Thanks turned you way be rate do that when QX stronger. seasonality the expected and low turned way -- the that from reasons I in calendar a perspective. with out QX QX, some behind QX for turned there understand how fell. we be may be look QX surprisingly it growth of that don't think to and than sequential stronger do to we QX, But Vijay has fully to The that it the you versus analysis. certainly do we even

on sequential to not a would you growth of basis. that expect kind So I routine caution

I we is appropriate and our launching, we we to is the and that I think expect said, CENTERA when that seasonal our without approval out place. for Scientific so in year, Boston QX quarter the mentioned our customers. would QX traditionally slowest the back the get And sometime of guidance with in And as it remember as lay is half

Vijay Kumar

and side, Cardioband on I'm one I'm what mitral in I contribution but in it Cardioband the being starts, the on its in mentioned heard mitral because just sure maybe not trial tricuspid area? I was mitral used about curious TMTT? certainly on Is for And Cardioband, being heard the

Mike Mussallem

mitral the situation and supply last Cardioband used so this position, tricuspid was both Yeah, improved. more actually the has tricuspid quarter. It in

our get better, curve to the operators see Yeah. so get supply that basis. allow we to get And learning so to -- pleased can regular apply that really in situation that some and down come we're on of a

Operator

the Fargo. from Biegelsen of Our next Larry Wells question with comes line

Larry Biegelsen

Ultra. congrats And on really quarter. on one One really, EPS guidance, on the the impressive

I I'm QX by $X.XX, the by about right, about by fiscal if the follow-up. only is the but the beat $X.XX EPS doing XXXX fiscal you So at EPS midpoint. midpoint one And had math the guidance Scott, raised -- Why of guidance QX that?

Scott Ullem

generally in investor Larry. the expected. the you're expenses sales So second math, about effectively But guidance. we about in This by and way, higher quarter conference came the our is, $X.XX over right than

trials also SG&A second online other And of we've so with than expecting as coming year, R&D the we half along got to originally and come in expected. expenses those. and higher go that we're new look at expenses the we some Remember, additional pivotal

Larry Biegelsen

little think to issues And delivery been have comments your you aggressively? on mentioned then planning are X update in And a SAPIEN the remarks? you balloon Mike And X to on prepared provide you Ultra, you now system the SAPIEN do color with IFU? rollout the Ultra the resolved more could more

Mike Mussallem

clinicians What we that delivery Ultra for are X X feedback we expressed lot many valve that is, on aspects Yeah. of is the also preference the a system. of way and express SAPIEN But getting performing. a SAPIEN seeing itself the valve favorable we're

the identified associated to that that the on So Ultimately, SAPIEN those with occurred incorporate system. has issue, into that impact actually The been we're were that less we this some that balloon with systems. have that of factors working issue. X will we there and think Ultra delivery have balloon

enhancement that expect a that in real So to be regard. we

Operator

Our Joanne BMO Markets. next comes the question from of Wuensch with Capital line

Joanne Wuensch

a dynamics. market. slower we in spend stable share market last the moment quarter, about to international questions, market, talked on And pricing the quick Two I want a

market. share what's stable about sure just understand I we're quarter, I'm to trying This make in market And faster a going on talking here?

Mike Mussallem

feel that growth did was with market. like comparable did second that Yeah, the pick procedure up so correctly you do we our the we hear quarter. think And, OUS growth in

this see And shift or really in last So quarter. year-over-year true minds and a either we is quarter our quarter-over-quarter. this didn't share

a it say. to picked exactly is little Now difficult why up

from Our team influence some the would came of QX. end positive X that came PARTNER news say that that in there the was probably

Joanne Wuensch

And continued are in and the in the then second understand also think what half to may low quarter. access second thinking I just of how you about that the helped And risk for want program you impact it the contribution?

Mike Mussallem

thanks. Yeah,

So but an want until in cap than improvement. second something there a in little it that quarter, quarter say pretty small. the is stays approval. was XX% first place program The more the generated It the I in to was maybe minor.

think I a So dollars. couple maybe million of

Operator

from comes JPMorgan. question of next line Marcus, Our Robbie the

Robbie Marcus

year. congrats doing give Great didn't just pivotal you both quarter. in implants and moving us an on, an on trials EVOQUE. the status EVOQUE? in patients you're I a is that this comments you for nice for update timing on MX hear Can update late heard the in and right those into mentioned if now I of

Mike Mussallem

the both with systems. on really with been feedback pleased are patients doing both We've we Yes, systems.

we We this before have, are the SAPIEN year. of the the to going initiate decided that trial at clinical end point, MX

the we One going is position. been with feel of which reasons literally thousands valve in comfortable has mitral used that that the patients the first because SAPIEN we of have in

the EVOQUE not we send So it about opportunity us but a excited mean that to don't signal there, we're an platform. gives start to

is also great We go to first. SAPIEN feel going MX

Robbie Marcus

that there an you're competitive of is of dynamics? others? Europe and quarter, pricing? growth while, This of some it's markets And for bit less it give the Was there. markets the it some little in some Europe. What it would of color the you if been international just you above been better into and doing about risk is that number outside in kind competitive good and But some quarter the well gave of you could a years. growth market on trends Any drivers that's you mid-teens Was could diving what be growing color maybe break doing maybe than this thought low a great. it impressive seeing a change expectations? out Was for drove second

Mike Mussallem

Sure.

that key element think, said approval that is is was I particular, at globe, Europe. is I mean, for go. already so that growth in But EU from than countries the do grow is the some of PARTNER continue we influence appeared its the penetrated really the driven think still double-digit risk to you was the risk Europe treatment really Europe, less that impact ways the TAVR. there what more remarkably faster by and extent have this that the to by that that but of there quarter had some So of level to countries, this. we the in that's were some at in was we that reimbursement a us and penetrated influenced no programs low around But In seen probably X Actually, data XXXX. low on end there and QX probably level in in come patients there quarter. will the experienced

Operator

the of Canaccord comes Our Genuity. next question from line Mills with Jason

Cecilia Furlong

TAVR EU here and to done increase you outside the about recently, in needs you've total just strong well questions. Cecilia about leg really number Japan trends is of taking TAVR establish the for I on number and And patterns? opportunity, This as referral for open you current be with can as centers you qualified current adoption juxtaposed to forward, wanted the and talk ask up region. the centers as actually thank work of qualified Jason to the what seen necessary the and the still to the look improve

Mike Mussallem

pleased been pleased in in and But rate nice not we rates are been treatment that. Japan the at we've growth Yeah, has the with Japan. all with

one and expect of higher we the stage there, it's not game because penetration TAVR be to population elderly large the much at would really the Given believe it's of this reasons higher is we that way be been system are procedures. that should allowed terms their centers the doing be start of more there limited in up centers and probably should it centers doing has that the and to more

we that. to So are and we to make in applying sure that do are proper policies work place do our to have energy put still

opportunity big patients at So a although, for to Japan it's a is higher much rate. still be treated nice,

Cecilia Furlong

does then And that very the could the of be term? still adoption what the expand the but are about training implementing, turning it's PASCAL realize used your trial within you're seeing And associated device? platform the following process, and the specifically initial to talk region programs And centers in you the just centers view and early Europe, launch platform in in longer you more in I just initially learning curve with trends your where ongoing as patients types utilization. this

Mike Mussallem

training so feedback. on done So early on procedures and premium that success great have a been QX. patients really adding the we We We've great are a accelerate sure been in hasn't numbers. that we about was of here, really procedural lot It put and for job centers and one making had saw outcomes very we've us. in that's gotten really that indeed great QX the during Europe number the much QX of well

our from projection going So, we you to that And to tell that's be XXXX. $XX expect can primarily around from do PASCAL. in million

terms be. speaks it the think So adoption of will for itself kind of we what I in think rate

Operator

with next line UBS. comes of the from question Our Matt Taylor

Matt Taylor

these implies a SAPIEN wondering a CENTERA. it's of I as if decision option you wanted you the the you that that you should do you And you're lot that bit to you discontinue discontinuing difficult additional talk flexibility But behind forward. does to terms certainly little I more in of programs? mentioned of some not going ask get or could in a about it have that question or So was which first going put PASCAL was, could confidence from other X, horsepower a what to self-expanding to have.

Mike Mussallem

evidence way incredible that the in You're body the exists this X the headlined of would work that bar pleased number to that need as well very CENTERA, in just didn't high is a it's terms way was and although PARTNER data of valve we there placed and about right, of And liked. platform SAPIEN has on all it in and X and of in particular excited performed a of clinicians systems and as delivers valve given -- performed also have as how really SAPIEN anatomies us The confidence are lot we a a perform. well. well lot

delivery us to enhancements So it system. have make some required would to

And risk trials. would remember only we that to give to would CENTERA at same we're trial the now an intermediate continue us the in indication time, do involved have

was we're next resources future we we're and on put apply we our it resources and focus existing on are but in platforms. as we our the it and where well the around a we altogether about excitement and going platform have confidence the when platforms, team how the going that thought decided how excited So of as much tough generations to made our to decision, that we have existing

Matt Taylor

kind that PASCAL And a you on just then can mentioned you these us investments spend follow-up on of as trying tricuspid trial tricuspid info the year. and a you've to where retooled in accelerating you the give to accelerate? of more where -- how later mitral Maybe second you're in kind some are starting and really this

Mike Mussallem

Yeah.

first going of is is one PASCAL kind So a really repair few side. on the things,

now looking pleased, the functional patients pivotal or to we're to significant program So had was patients primary treat. be on patients of able launch trial degenerative because we that excited a that we're for secondary group these focused forward and or we to about, a a are that's already

trial tricuspid PASCAL. first the deliberation, decided side, we lot done of after be On that a our should with tricuspid

call. made that we So

made to decision tough heard that that the we FORMA. work and decided the have on discontinue we also You

one, that would terms we're discussions of that so trial look in what with And design in FDA like.

time, a the and into late you are going sense, this that explained trial mitral gives with same MX I replacement clinical so the year. we where just a And at we on hopefully think

Operator

Suisse. Our of Credit with comes the line next from Miksic Matt question

Matt Miksic

the echo everyone's on congrats And quarter. I'll

of maybe guess risk is the and think to said Mike, things it have that PARTNER access continued times of the on it awareness of impact to you that you folks I get and was one of if sound really like trying drove in, quarter I been se. And but the doesn't it a elaborate, doesn't data. strengths like the it per it was sort patients and So, few low could the sound what came

up. I color the the, indications awareness any does stroke is translate risk of that So -- follow say, stood on one something kind can let's or how mean or risk the or something it conversation I out change -- volumes? had intermediate then into it you is like provide for that And

Mike Mussallem

and call and a issues the of the the I serious of of I presented people this moving that that that data plain and one little that move confusion at drove party, there We a a fast. a point quarter the the first variability that of all bit could believe thing We really was through think this and just lot through was We feels quarter. don't I the but wish there are buzz, know that to you understand second people of lot that birthday system know in I a like is bunch this excitement here. it started generated QX end system. between --

we people XXX through could to or even think take it for so move And XX days, it. oftentimes, more

question QX So gotten have mark. is could how and much in stimulated a move

risk we again, So there were We don't number quarter. don't of the were think it significant number low really We cap. the that of just think the procedures. TAVR a patients treated was think of about that in overall stimulation it's

Matt Miksic

Maybe -- difficult it's or and again question QX heading QX. I pin to but per sequentially into understand factor, year, just XX million QX not cap down mean down, to you're let's about a similar not a se. say so last talk seasonality, then I about

the down hit come that what it number need guidance to laid order would sequentially think. maybe way does come you've cause the for to I out QX? And in down say to

Mike Mussallem

Yeah, it's a good question.

slow know for you quarter that is customers. our QX seasonably So a

ago, growth QX remind of it after in approval that why happened. goes and that kind so saying, lower exactly it sure wasn't but case, the I'm fully long we we was you, explained that XXXX, without QX than not I'll so got And the back was

to And stay about expectations causes what so moderate thoughtful our and just are. it us

approval approval. of expect slowest times one year. the come again, the of have to probably likely We it’s to does during the come, But if

Operator

Company. from line question next the Our & comes of Josh Jennings with Cowen

Josh Jennings

on Just questions two risk approval. low

approval narrow for we have next timelines the later in is, XQ. that one And to thinking occur should we And just confidence of quarter range gives thinking kind the in in be be the September? what the or week follow-up. just could to approval First one should -- then about you I guidance

Mike Mussallem

understand the you're Yeah, Josh. question. I where coming for thanks from,

we down questions. when what usually go winding So usually questions the happens through when back as and tell or questions final you they're the to coming and forth can down with FDA are

feel And pretty us we're makes so it close.

come clear things time whether at same approval be at not our could a that's whether the competitors FDA might the the is time the of factor. move or would to One choose two same

any we QX, So know we're can't saying than just based on be that. more but everything specific we probably

Josh Jennings

And just the approval label. of risk in in low terms

months gets Could in of Medtronic our exclusion data have view. together? of don't gotten you up days expect check I I early enrolling a mean, just is, kind think still until follow is that to low period of But the advantage of have advantage for top bicuspid understanding you've just that, It's sanity risk labeling approval? been you that of the you couple segment still is I on any wanted to an clear a in that bicuspid, or bicuspid that could Medtronic ago. arm your enrolling the started

Mike Mussallem

is and remind be just to the contraindicated bicuspid contraindicated or today audience not I'll it Yeah, future. that do in expect label the the not in we

quite Raj encouraging. saw You Makkar's data, which was

forward. it a going today. like it be be in feel treated competitive We much So to I'm it's going will future is of sure the comfortable not that much dynamic

Operator

question next Guggenheim. Chris Pasquale comes line from of the with Our

Chris Pasquale

quarter the on guys. Congrats

better So the to there? trying is regulatory how start enrollment? for off just Mike completing Just with timeline CLASP to close to get a sense IID

Mike Mussallem

it's we as really have to that. to on centers. share This the more So I we've activate is we've We we going haven't more It's a a mitral to us. for as out continuing enrolling take anything think this. while. in is been laid trial transcatheter proceeding planned. We're largely time planned. But don't been like that we think it just first engaged largely what going

Chris Pasquale

looking what Okay. Can any difference seeing. types about you're position, you're encouraged new you're for in but Anything guys of be more versus bit to moving PASCAL? What ahead of by you little you in set Is data We seen the terms talk yet tricuspid you patients one can helpful. the you studies? suggest there going a share two up to a treat ton that how these on haven't into that Cardioband be would devices of trials opportunity? are there

Mike Mussallem

these have patients. don't much is really So they new Today, this for very options. going to be

be they are as and help able of clinicians One the we're really that these say, enthused could a transcatheter we use to to option enthused reasons patients.

improvement the back we those though done even tricuspid position feasibility call, that. systems of their earlier have each consistently quality patients really an three we mentioned and that early the on differently, heard As of get behave in we've actually life in studies following

that this We're course of point, we actually a not the to at in going do FDA at a probably. that management some high-quality with medical Now really but to of have it's kind working trial clinical anecdotal trial that's be need point. this fashion. compares We defined to it

back will it so be fundamental. And

Operator

Jefferies. from line with Denhoy Raj Our the comes next question of

Raj Denhoy

could start TAVR? on the out have impact your few already what NCD, updated Any thoughts NCD maybe you the expanded are on the centers or the wonder thoughts will a came starting offering I NCD if seeing up gear get weeks new I ago. on and that to market to that

Mike Mussallem

the when treatment of I to So, open the of reasonable estimate the TAVR going of a we requirements XXXX. modernize are for that are is to streamlined CMS that think that number approach often and achieve treatment look and anxious it's and to by programs We that risk think centers it we faced have end patients say aortic is patients. a but not more really initiate will the that know at new thoughtful approximately receiving that eligibility be we we could to primary ahead, all stenosis the complications, there TAVR sites really a severe commend not XXX risk for program

Raj Denhoy

previously? how context, that would be expansive versus will your volumes what's on in And of sense that have patients to sort that cannibalizing been procedure referred

Mike Mussallem

We in larger patients. mean pathways for get new past think sure, think often out new based often trapped referred to we necessarily centers. centers the that other patients Yeah. this We experience, are referral on don't don't but our and know

that's we to going turn out. remember opportunity infers the to and we significant then. But is additive. by be out way overall, planned grow all of pretty have of an estimate it billion growth out to that part to think we So The now And and had would kind for think $X it. hoped turn had between which going it turned is NCD it the overall that a rate we XXXX,

So our not really outside existing of guidance.

Operator

the Our with of SVB line Antalffy next Leerink. from comes Danielle question

Danielle Antalffy

sense any would But would seen you about I quarter? age moving a or a many birthday on, a to considered lot well borderline And do these how a be on of of be that Congrats the patients patients -- a mentioned XX? a of any you age have now? have sense you patients, might is didn't in to I'm question creeping was wish have you it this borderline? Is lot. do this good party. where sorry, of or some that right quick mentioned you look And just anyway, have it question, these Mike, quarter. really any say been way average -- maybe Is at better answer age, still it of you've

Mike Mussallem

favorable the comments. appreciate I

we What anecdotal. know hear You is quantifiable. anything don't what, have we just back pretty

don't really I for was we we think that was The was just the for borderline an But it patients whatever a can't we there factor. track think acceleration. majority, think you. So it reason,

what's in by a track but or lags two. going on we that age, So generally quarter

have this handle time. clear don't on really we that a So at

Danielle Antalffy

how with because get we too actually cost on you can't but competition, understand love limited relates healthcare Europe I valves, grow perspective got might access just SAPIEN I wondering but about hearing, Europe follow-up volume just cost of you systems even over guys as longer and some patient in at the a following a address the it's have as then very around up term? we're the And feedback some PCR and Joanne's quick of you it volumes, and and by happening we they on and from are not but to What expensive been need because just price, disciplined the was, conversations question you what's to of cheaper. X, in have Europe that

Mike Mussallem

tough a to adds importance need in that Yeah. system, and some quality cases, the fully life our of to job with in therapies that's really they year makers forth, can it value it job system, like physicians compares TAVR the to We in and do. value reimbursement better Europe along you That's many TAVR. they technology. the but place, fully of aren't are compare wonderfully think and a this to what have add that the do within would existing the of what's the of the quality about we live a pay therapies. think don't of reflect cost therapy why for so value with prepared policy the We the goes I systems so Actually, some understand healthcare when We think key to other influencing with to for us.

Operator

will from line Our Chickering Pito come of with last Bank. question the Deutsche

Pito Chickering

questions. of Couple

these rate on Ultra versus how for of order refresh are in XXX% the centers you using What first US on quickly that The And us can Ultra? you into Ultra? the SAPIEN number is X? of the one, are centers converting

Mike Mussallem

system in projection a before we all ultimately would we Ultra in replace that the the a Europe. SAPIEN geographies. don't of I procedures in number. for we think going the Ultra year small were majority So, We Europe, far we X did it It's will in US. know the of say give to We along the end thought of of and that number the further overall, account be were that didn't how

Pito Chickering

to about two What to how should up in more impact lines in ramp discontinuing And gross questions. you as Okay. as margins think shift Now Europe, into housekeeping your gross impacts production capacity? full CENTERA they how your have two need margins? Ultra valves then that we

Mike Mussallem

to margin saying, the switch how SAPIEN X? Ultra our impacted you're by from So is gross

Pito Chickering

Yes.

Mike Mussallem

more negligible. to pretty been the have to it's pretty, is Ultra would comparable that's CENTERA system make, think We but Yeah. expensive a SAPIEN X.

Mike Mussallem

welcome telephone. right. to now Mark. in that, your And with Well by any for interest Scott, you, back everybody Sure. you Mark Edwards. and questions I, thank continued All additional

Mark Wilterding

on Thanks, numbers well during the for Scott us and growth call. at GAAP release between special and mentioned amounts all can sales Relations section for as edwards.com. items are today's non-GAAP and thank Reconciliations you be which in press adjusted of underlying and as rates website joining the in call, Investor included today's include the found

for will this, use of XX number available hours. XXXXXXXX. please be and missed access or ID today's call, conference XXX-XXX-XXXX If dial any To portion the XXX-XXX-XXXX you replay

Investor replay an Lifesciences the website. be Relations Additionally, audio available of on you. the Thank Edwards section will

Operator

conference. you. will This Thank today’s conclude

participation. at thank disconnect and may time lines You this you your for your

Edwards Lifesciences (EW) 23 Jul 192019 Q2 Earnings call transcript