ABMD - Earnings call transcript Q4 2021

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to Fourth Quarter 2021 Abiomed Earnings Conference Call. At this time, all participant lines are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to Todd Trapp. ahead. go Please

Todd Trapp

Minogue, morning, be earnings Good President to fourth for with Abiomed's Chief Executive and Thanks, The follows. Officer. call. and This XXXX format Mike here I’m conference Officer call Vice Chairman, is quarter President Financial Chief will Sarah. today’s and welcome Abiomed's as Todd and Trapp,

press we results, operational I will then open Mike discuss which outlined to First, were and your will that, fourth highlights quarter release. in call the today’s our will business financial After and questions. review

me our may would we begin, update in cautions variety with a to filed any Before statements SEC. and future. identified most our today’s that press differ call factors statements. and any to of results guaranteed and that Chief forward-looking and Officer, forward-looking With the I obligations involves earnings recent company materially Mike not Executive like XX-Q The XX-K due not let Minogue. Abiomed's Chairman, remind We turn and undertake to call uncertainties the are everyone President to statements. risks do forward-looking over includes in the release investors Actual that,

Mike Minogue

support algorithms practices patient medical track company We Abiomed on-site and to pandemic, standard the from morning conduct and our Abiomed and innovation executed, Todd, The our transitioning successfully in circulatory provide yellow education and training transformation the X.X. smarter playbook. while best care with Thanks, COVID X.X care. on identify to marks support. with and course a red, and green for everyone. connected smart the a Throughout optimize advance utilization more patient of has good COVID-XX to device into real-world phases cloud, our remained become We and and online online and adopted

year-over-year and up revenue the record Abiomed $XXX Japan. U.S., across the Europe quarter, growth XX% million in a record delivered double-digit with of For revenue, company and

improvement Abiomed Applying record we sequential transitioned and patients a utilization. while supported COVID of a and a in we in day, margin. patient both continued, QX. a global saw with a QX to phase, Within our week monthly in playbook, investments X.X month, in quarter, validated number operating the quarter, achieving GAAP all green revenue in the in definitively XX%

to help the X% and delivered Turning COVID-XX year, and the fiscal Abiomed achieve the million a $XXX to us plan. revenue, full uncertain took the disciplined We margin navigate operating environment year in our approach to despite pandemic. fiscal up XX% year-over-year tactical

endured pumps remaining on the COVID-XX making invested keeping our life-saving new expenses focused and fiscally expanded and innovation, patients. hospitals responsible. distribution, safe, while We Over the of setbacks year, controlled and in we studies employees heart past and clinical supporting and

ECMO and an balance Our zero in cash, platform. $XXX to strengthened sheet debt while acquiring maintaining million

lead, manage, patents X,XXX courage In At and gives regulatory and pending. IP opportunities addition, online Impella adapt PCI. patents portfolio our mindset established CAMP always our achieved number of to to us execute. seek We and we XXX training approvals increased education a and First purpose with and Patients Abiomed, and world-class significant

For the exited this pandemic. and revenue, year stronger profitable courage, thank slightly like in patients before. I customers ever and to to employees their the leadership fiscal dedication would throughout We and our up year, than for

in Impella rollout online our Connect. and allowing XX/X XXXX, year into that I support. level the fiscal the goals success provides will beyond. call, are fiscal on-call In patient company accelerated multiple meaningful monitoring capability, Abiomed patients Currently remote cloud drive environment. across on-site, innovation this the XXXX our in with momentum highlight us of XXXX our go of fiscal U.S. populations, our to Impella starting in revolutionary hospitals with particularly space innovation in launched COVID at year live the Connect, today’s nearly For other and of our will and No X,XXX our This monitored is XX%

Japan. expanded and also our in Germany have XX with global We footprint hospitals Impella Connect hospitals XX at in

Impella results. Next, deliver X.X to SmartAssist strong with continues the

quarter, year-over-year as more to XXX Surgical XX% we U.S. XX revenue the expanded Within grew device our sites. totaling this sites

surgeons. the driven higher failure The provides patient comparatively treatable U.S. fiscal fourth survival for X.X directly heart longer Surgical rates BTR into a the fiscal forward fully it an the population, inserted revenue axillary is within experience, a utilization. and patient our revolutionary artery flow about It and For the product The quarter Impella minimally heart ambulations. is full unloading first-in-human strength pump the grew acutely surgeons has are U.S. native pump, for via Heart additional expected for also year, representing this heart patients. X.X patient in invasive, year. and reported because designed in recovery enthusiastic duration year-over-year, support heart decompensating XX% by Impella or designed aorta heart is is of XXX,XXX

use Medical from Maryland interface and Abiomed physicians portable XX been with System, light the design our ambulation. have now on this patients Breethe to Breethe in of and at has system our I The to OXY-X for Baltimore innovative Customers a the In met positive. cardiopulmonary highlight patient bypass nearby Breethe the ECMO treated sites. several Center. at support the facility Turning date simple visited ease feedback we March, University compact allowing of on intuitive

to connected We this will continue technology smart to innovate cloud ECPella and monitoring. with and software optimize plan

study we Impella our our on true to progress, French a the for advanced ECP, Moving feasibility early U.S. X pump. FDA heart regulatory

feasibility for multicenter, community IV of needed XX prospective, to randomized Detroit. approval of enrolled The excitement and to a on-label, have field important date. that first Class to is I and studies for XXX,XXX clinical and the PCI in patients. we the in future. leverage the reminder, enrolled U.S. new RCT heart defined controlled addressable received expansion the market for we community’s the high-risk a PMA over XX is for patients leaders of our at led by palpable for It is as PROTECT FDA to IV As landmark in clinical trial is PCI. the in of in designed failure have announced Impella designed the evidence St. practices patients global the that recently early John guideline trialers intent treatment will note We the we trial engagement failure Impella have study provide The validate high-risk learned a to past, IV the achieve years PCI believe best high-risk XX in a PROTECT current PROTECT our QX, overall It early series to CVAD the Ascension In past study that medicine. level in and propel to PCI be best we alternative. as is Hospital PROTECT that FDA was an approval for of patient the the cardiovascular to exclusive high-risk recommendation the and heart PROTECT IV

Since not high-risk we PCI being the XXX,XXX not population As artery are now the a our result year that we diagnosed patients. U.S. or be identify programs for coronary the referral new will estimate Protected to tested PROTECT investing high-risk outreach to XXX,XXX heart surgery are referred study, turned spans treatment of better expect that directly PCI for disease. of PCI the and is and PROTECT theme, on-label IV addressable due we IV for in an study additional patients down population this under-treated for patient

heart the disease context, U.S. per and in it cause coronary year. people of disease leading the with of and artery X deaths artery one For heart million number XX Coronary causes is the death death cause million failure people Type and X have for failure and overall, diabetes. approximately remains

in of a standard we forward care goal solidify path not study we this fraction. and the of fiscal While line have and high-risk sight year ejection for complete of with complete patient quality will new life and XXXX, revascularization of PCI to the in improvement now

I some Impella lead distribution beyond in on a advancing to of Finally, our investments with XXXX excellence and focused establishing extending with team. for innovation, evidence X.X clinical goals our Abiomed and premier want fiscal commercial highlight

improve as innovate support in that outcomes. continue best-in-class invest and to to clinical will heart smaller, of and First, are R&D connected ease we technologies smarter and we lung use

to the with the RECOVER of STEMI I design cardiogenic achieving guidelines plan Class including we Second, shock RCGs goal overall. and IV multiple advance IV DTU, PROTECT execute

the we expect addition, In of complete the RESTORE and and EF. in efficacy importance further revascularization publications high-risk to PCI with Impella of validate III the safety and PROTECT of

PMDA Japan. adoption. on and Europe physician-initiated SCAI Initiative finally will our will in FDA evidence This we years also consent, identifying of our with derived from outcomes deliver patients and shock Committee and and through to For and cardiogenic recovery. heart patients, improved onsite Japanese are driving these U.S. randomize improving Sessions MHLW Separately, camp XX shock, patients the distribution the expansion survival cardiogenic goal to presented Because best-in-class online studies And native are the National training by the and of and be U.S., positive a practice yesterday real-world of protocols results new and XXX,XXX Shock plan best the with over difficult leveraging for Cardiogenic education and published. combination over published. Heart positive at presented physician-initiated focuses PCI prospective results PVAD paradigm clinical the Scientific Impella and be

with achieved for Dr. Chris the heart fraction difficulty old was he wearable after conclude, surgery was wife became heart complete around ejection gradually Zachary, day. the buildup high and at XX%. Sales want identified when and poor Louisiana a Dr. I local appropriate local Chris him sleeping, discharged clinic. too Chris's Chris coronary Abraham December XXXX, an CP he to and risk to XX-year story. bypass history experiencing Abraham breath General help husband, cardiologists, of revascularization of He trouble lived In emergency with the pump for where medication share has for PCI scheduled with from home fluid heart discharged Impella for told home disease advanced hypertension severe over as shortness next Abraham prescribed few – defibrillator. a and of referred his has Impella. was abdomen with he was Chris's candidate When experienced Chris Baton with successfully interventional XX visited the failure Kirkman, patient to at I hospital family Rouge he the a diagnosed Dr. a and disease with sent a Before home. Chris Director symptoms and procedure, breathing; then more congestive next was father was He drove Bluebonnet. months and protected returned years.

improved on circumstances most be conclusion, care a challenging risk high be to of populations fiscal new for successful customers very because professional levels I'm a years During heart clear ejection our have just new to We their proud the for his stronger back the one Today XX%. at continued failure tenure both dedication call Abiomed patients, and not And our follow-up is pandemic. but during wife standard heart in great for and employees we lifestyle of turn over Chris's we and the children. of from the world. customers the a support COVID are Todd. healthier the fraction out delivered multiple to look enjoying growing now work Chris path In productive shareholders. to company confident our will excitement with and last exam year around that company, a thankful I three his fulfill to X.X drive and and with of mission. as I courage CEO. patients recovery fiscal will will sincerely today XX-year personal Despite appreciate Abiomed execution a and am my our

Todd Trapp

good Mike. Thank And everyone. morning, you,

starting QX Now results. with

$XXX our high-risk Europe an green As and XX% in innovation, first where Mike revenue we PCI us to the We to mentioned, we year-over-year million, the current grew levels and We growth patient regulatory the clinical performance; with across The increase Abiomed U.S., double-digit into Turned patient to of X.X utilization. few by playbook, which XX% driven patients XX% Japan. grew which impacted weeks the double-digit and delivered of revenue hit transition revenue peak a utilization. cardiogenic leveraged million, year-over-year and COVID increase growth our in delivered record milestones on allowed January, $XXX pandemic shock. environment. saw in phase U.S. despite of and both our regional

hospitalizations related in decline sequential playbook, each we and patients cases in our of we delivered COVID to month in as revenue quarter. improvements the began However, executed and

revenue and patient QX U.S. end a set the also our now We in At CP in fiscal the the March. in X,XXX record is of sites.

prior in placed the sites have sites is X.X We quarter. X.X up Impella versus now XX SmartAssist Impella XXX with XXX and in sites, the

Lastly, consistent was U.S. we average in X.X for hospitals and below QX. XXX% the in sites, the up combined inventory site, Impella per inventory the is X.X the Impella RP now slightly with in quarter performance at and XX XXX with QX. versus the units saw CP levels reorder

the Europe and $XX outside QX million, total XX% Japan. in by revenue to up strength In year-over-year, Turning U.S. was driven

Our Euro-U.S. European we COVID such utilization Similar revenue the U.S. dollar patient in impact increased rate. XX% the higher saw an several year-over-year to UK, deaths Austria in as and accelerated. lockdowns to certain January when due from Germany, and mandated exchange Europe benefit the foreign as in and countries cases markets,

utilization. the opened However, in bringing the million playbook, improvement quarter. perform delivering We revenue, continues plan XX% Japan and quarter COVID new patient executed to delivered $XX.X total in the here sequential driven sites. throughout we our too sites well our XX XXX leveraged up on by to year-over-year very monthly

QX System and $XXX year, PROTECT we advancing for danger. prior offsetting year. stock-based evident due year higher in operating of year. to in to was million, an from and to flat investments clinical continue Moving OXY-X income million, The quarter volume, The again to gross higher the grew prior and invest to $XX will versus increase XX%. innovation variance from value team, $XX to margin in forward; GAAP based expanding distribution our STEMI compensation. we create incremental and stock and of our in benefits targeted was has the advertising total share for driven been past expense to the $X.XX the or growth In the QX up million margin DTU with for XX% higher value million, production material evidence XR Sheath, Impella an prior the X% made mark-to-market in $X.XX translating it compensation. compared stock expense we versus spend, year totaled investment versus as BTR R&D was Net Shockwave. ongoing ECP, the The due Impella prior in in throughout XX% SG&A XX% with increase the due $XX Net of quarter increased by XX.X% impacted IV, investments diluted quarter. believe income compensation. increased the income XXXX. and our EPS reported by based Shockwave quarter per primarily $X.XX operating Breethe

of $XXX Our for operating balance remains flow sheet and $XX approximately robust. the cash generated In year. we million million QX

year million cash, year, the $XXX last fiscal remaining or a XX% with As in result, we while versus ended debt-free. $XXX million up

Our investments. with balance well us with sheet strong provides as stability as flexibility to continued make

we Now full year COVID the fiscal the were it, within environment, executed goals. our challenges turning year and the remain our disciplined agile on to navigating but by performance; throughout presented

to fiscally for while operating XXXX global to year. prior million, basis, and XX.X% We compared prior respectively. patients took of Europe discretionary geography revenue the throughout result, fiscal the the control year we to $XXX investing grew improvement levels disciplined while X%, margin. As XX% costs, In approach fiscal an $XXX and both equates up operating X% R&D, reduce XXXX, year, innovation. expenses the in which XX% million, year, XX% despite revenue a in a invested income a of saw at million year-over-year. quarterly U.S. temporary and and and $XXX GAAP instituted we down delivered declined global versus actions was record We X% increase year-over-year a Japan pandemic. and on By the year

per XX% investment heads by in the or added versus $XXX increase in in prior diluted year. Net fourth year primarily million driven Shockwave. was million the the for or XX we was Additionally, $X.XX $XXX toward income our the The equity team year share quarter. within occurring our majority with distribution $X.XX

Lastly, to year for guidance fiscal XXXX. our turning

to vaccine year, expect by a full At social At resurgences, end high revenue XX% strains, new which namely $X.XX our with year. distributed, be continued end have range and to to the lockdowns, cases growth the our assumptions lower some to our vaccines the $XXX of which economic national XX% the to business. million to new are in a recoveries caused leading we For the and broadly return billion, include effect customers COVID on normality, guidance range COVID, assumes our should translates the and and of uncertainty unevenness low positive in for availability, adoption.

resurgences, As the guidance, pace to geographies, different would as across we year. expectations our anticipate typically on to color continue recovery I that remain the some and do of globally. when like will issuing utilization endure our fiscal QX to we vaccinations we provide uneven transition seasonality In

QX However, we in QX be above to $XXX our flat believe continue in to XXXX and revenue vacations. slightly We million. environment pent-up is XXXX potential our of to believe playbook devices and patients cardiovascular a QX the remain and the and could efficacy be in seasonally for to year, lab revenue demand this execution treat Historically the ability confident exasperated summertime slowdown this slow quarter the will this and of cath travel. physician for due in given vacations

be So QX below we slightly or to flat revenue QX expect the pace.

we back to best increased typically QX to see transitioned based and hospital activity the we sequential our year, year. have the expect in we March in our quarter, lift our QX, as As we end physician fiscal results on engagement. half of And

with control support investment and further incremental R&D lung step efficacy margin, technologies, margin XXXX portion distribution. to Impella fiscal best-in-class investments of evidence validate our as range A up be our innovation, to the to innovate of we randomized clinical targeted multiple of trials. year XX% the Turning in and as safety be expect in operating and will significant we heart and we XX%, and ongoing

and year year was for training we our and programs. initiatives, challenging, to but accelerate Abiomed X.X. as education to fiscal We pandemic also the us a transitioned grow summary productive plan endured XXXX expand distribution, our very marketing and In

delivered to GAAP XX% and long-term growth. million, of top pleased continuing $XXX sustainable our make cash investments all drive necessary to increased growth, line are have We operating Abiomed's achieved while to year-over-year margin to

through very of have excited recovery. Operator, of the line for We the globe come and our commitment I'm for field to the an year. accomplishments. now for hard work as heart for new am and please questions. exceptionally proud I year continued build the employees around challenging the ahead we their open

Operator

the Instructions] Our from William of comes question first from Blair. Margaret Kaczor [Operator line

now is line Your open.

Margaret Kaczor

then bit little start Hey, I good for taking wanted Thanks question. morning and questions. the guys. bigger a guidance with picture to a

the can we April? look March more assume you of any years. on maybe that kind And maybe as as green last that what at given we a of first, of seen And better QX given it and in than bit does moving the And you're that that you why we're Todd, you're the clarity recovery little So to like X% as X% then made into shouldn't on and the in several provide we back-end historically, the kind phase. QX? had comments looks QX high

Todd Trapp

for Thanks Margaret question. the

So in you, March, there QX, last that improvement March. I if highlighted if bit was about in think an you would of we sequential from in argument did you and I our little start-off our say look make deferred, then can the in on that were call. February at PCI January fairly bolus procedures that see did January. performance we into high-risk we would just in And December progression soft tell a you

actual to it not So going this perspective, April performance provide we're as of point from April time. looks

color that point in provided April. prepared what in to for be at think slightly QX the on ultimately think QX, we far have above so about we've we based in that remarks sense factored our it time we this seen makes would that but I flat into

Margaret Kaczor

really, of differences relative then the these to And well. given there, seems X.X of to X.X X.X. numbers you accounts, Or utilization are in in our deeper improvements? – product Any do really of kind the in to color give terms from accounts going maybe X.X, you least can Yes. upgrade at

Todd Trapp

over our the in quarter. business, X.X, Mike's XX% was up Yes. I mean surgical that comments

today. So hospitals it well. over continues perform XXX in to very We're

We expect that continue. to

great continue If product, well you into are up to our fiscal substantially year patients see X.X. and look It's I at that expect XXXX. momentum a patients, on our as

Margaret Kaczor

just bigger little Okay. kind of one, last kind a of And again, bit picture.

There's the guys ECMO things ECP of You you've right a got in the platform, investment lot and the now, that whether have out rest. investing side. on even on, a lot Shockwave the the RCTs; going it's you're

of Thanks. the next of the to types As do you're what's next you on? to two those outline various you opportunities? years, think about your three spend how kind going thing And that cash

Mike Minogue

Margaret So, the for question. Thanks Mike. this is

come innovation, and picture, On out all research distribution. on the of on in on COVID-XX big clinical we

so to going that continue the think see you're in I And tactical to execution.

to Impella the going to are recovery. you're these see new execution revolutionary, X.X, to bridge Connect, it innovation, – are going focus I to that failure For this continue the mean on take ECPELLA, ECP, that's of the products heart and ECMO, is innovation heart new recovery. these

clinical high-risk in and we're we've For summary PCI. and the a slide studies we've now website. survival to optimize learned research, leverage studies shock, we've baseline clinical to that how the acute on the on posted just now We've a for return taking optimize how of heart and we learned the our all – how done and shock. to But chronic on to optimize cardiogenic learned it's

the cardiomyopathy So patients. these are

working We of course, further solidify we on. lead our we're across those to things patent position our we're so as going the we're going think board. And go. And to are the

a So standard the shock excited create cardiogenic STEMI, of for do prepared I my will forward said for I we're in new failure PCI, overall. path remarks, because heart high-risk care and very as have think for we and for

we're So the out where year. to are of be coming excited we

Margaret Kaczor

guys. Thanks Great.

Operator

Thank you.

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

now Your open. line is

Chris Pasquale

investment. where of XXXX. in questions. a bit That's down appreciate just, margin from XXXX, from and FY XXXX circling guys couple on a obviously, to year. Thanks the and One, you down, were congrats guidance. on back the finish the nice I Todd, A quite

spending coming also You bit. in increased guys But got up some quite a clinical starting off trials year we're R&D a of which to here. ramp

doing to there. distribution that's you on standpoint again? step-up? other one-year And require investment a you're profitability? into a multiyear start a see elements drop leverage a you are significant And you of would the will different curious and this the is What into? Or this do view entering from phase as So just then

Todd Trapp

investments what call, the for I our, enhancing think about question, would When mean, for in I year, Chris. on this growth Thanks I all investments. Yes. we're our

it's innovation, distribution. evidence and So its clinical its

investment require So I the with term when connected clinical think smarter, AI us then think events study making devices, that really When look feasibility you the Breethe. about about R&D. smaller, IV, investment. as again ECP, look up long innovation, another investments at it's the sheaths, would which in PROTECT at expandable more BTR, They're open the for STEMI, continued for algorithms, in I investments not heart more and evidence, it's we're XXX,XXX digital in patient really population failure early ECP. these

bucket So will third I see we then big execute the a distribution. as R&D time, think around over our you'll And trials. moderate percentage is on of sales as

our expanding Chris. distribution are We team,

of looked we are We and smaller some COVID; at performance perform larger than regions that to we regions. went our over – tended better – you the back our if noticed

decision regions So that United we've from investment to the in made QX. XX. to making We've States the XX started in go

a bit that more little QX. investment see You'll in of

distribution local expanding having on putting and team, the So leadership. we are our more feet street more

we're to little going on advertising more shows in doing and initiatives our a PROTECT that be And expanding We then are again, utilizing targeting XXX,XXX his that untreated trade education. comments, Mike highlighted IV. bit population, direct-to-patient

be, and of us. next to most XX% that a pretty margin of over is for it XX% XX%, line R&D in think year it two. temporary XX% top investment going operating the With some of would in say, year big given XX%, guidance or to It's R&D the driving fact I I strong said, So midpoint to that still at of we're growth. is our

Chris Pasquale

helpful. Thanks. just to follow-on there. And maybe That’s

brings we're as on really touched who which undiagnosed, are direct-to-consumer trying to not type that be could get about country. you're initiative, at of for broader heart who questions high-risk always this the these of But of appropriate disease It's at looking feasibility for population. talking about of some patients patients not PCI. this up You in getting if population

especially the is it penetration So patients diagnosed how PCI within the of into still today? those relatively is realistic fold, since bring Impella population to supported low really

Mike Minogue

insightful Chris, and relative why that's there. a question remains very out PCI good to high-risk still

turndowns. lab nearly cardiology down management you turned The been out the they patients turned and of at went of cath the all for and weren't because considered failure surgical invasiveness is PROTECT is surgery, WATCHMAN. really patients that identified IV to and The at they the have a the what or PROTECT many When community patients TAVR, They look same of had down. they technology. optical not consider specifically are thing medical well which the with and as the didn't started, true If they in exciting when failure were PCI. about is went surgery, but as cath And heart for the considered high-risk of don't lab, none those for patients the engagement look these heart they started, PCI those general mitral II already practice.

about involved what's Protected is fraction. improvement with their an down in don't they're it growing for population, what unique therapy the IV forward, up Protected is PCI. see patients PROTECT presentation. They our He design ejection and these does moving that one this PCI as poor in of want other or show the patients days. it you What's – study. Type show diabetes fraction in for in opens is essentially and and an physician have And benefit that said they're described improvement broad XX another it failure life new that And a of surgery. can because a So a in PROTECT ejection quality day turned their heart IV X

people are up at historic look unique. And cases, – XX% at so show less actually in do the it and the when for – admission. And than of that in types that's trends, getting disease these hospitals, it's of the the the that And for usually at they around what's coronary index we revascularization look X% try now time people – look time. to the of only they

there's that did has been the anyone's surgery, That So in a past, lot because only PCI failure CABG. was it's not with open done there. not with opportunity the heart community looking not fault. EF. And solution It's or heart of considering just a PCI improve Protected at

to gain. community that's heart the able that forward, that's EF. be multiple and III will Moving And we've heart in get believe something engaged. overall PROTECT RESTORE II, FDA the I studies, And been – failure PROTECT in also show failure will why

Chris Pasquale

Thanks.

Operator

you. Thank

Our from with line the next comes Anthony Petrone question of Jefferies.

line is open. now Your

Anthony Petrone

Thanks quarter. I the PROTECT is one Congratulations have morning. good on one IV. on reimbursement and Hope and everyone on

first one Maybe seems perhaps to maybe that? It in proposals viewing from and – on specifically adjoining PCI, week, the XXX a sort add just reimbursement on and IPPS codes. is recap earlier the rounds. overall The recommendation actually that you’re how this proposal high-risk maybe streamlines just shift forward going a to the this of process cleans-up rehash sort of reimbursement of future the

on there. then So maybe IV. PROTECT have follow-up views just I'll some And a

Mike Minogue

patients. about solution. we with the We reimbursement. What platform thanks your for question Anthony a that and we've the provides talked pleased, is multiple agree on Impella it now comments. always is a with believe permanent CMS We're and

And so the in we pricing. position of future the the reimbursement and even products the and some

PCI. a have procedure. pump four-hour That's a or You high-risk

smart on That's on pump. a Connect a that's with up the got algorithms. patient, four-month the to in a future BTR Impella patient patient four-day patient. the X.X and chronic And cardiogenic you've acute shock – four-month shock this potential with got You've ICU

So definitely what aligns it doing. completely we're

permanent – for and We think it a differentiation with solution. that the really strategy. it's more And of provide. hub-and-spoke the permanent for also resources our allows support we aligns it So do type

we saw regions. As we – and saw when in growth hit, COVID to Todd the that mid-sized small mentioned, bigger hospitals

So we went more and also in faster centers. a we adding regions swing the approaches. in But massive March more little and bit team a little a large back bit saw leaner by

with cloud that to be Where monitor We'll work know a then to has to outlying the together with they then support. our watching. make that do But work most our top up we're distribution. to them place cath DRG any patient stabilize decision be also help lab, of XXX, the piece the send there patient also going it. part high end centers the want so complex do this in And center. did can And spoke centers. about we and going increase We're the with coordination. to allows hub-and-spoke the our to to if in those the CMS to ends which last what slightly if hospitals do the and was has Impella, The of

working but in overall going have this transplant a go we dedicated There with also surgeons are rebound But heart team to also to that failure will really and a of to patient We put with help on excited this recovery do centers. us XXX that's will advanced RP those We're referral And the now care RP. did deeper in are We most those to the that allow labs X.X now well quarter. SmartAssist heart we're chronic about BTR. directly maintain do the cardiologists. work cath to them think team all going it that's distribution the heart that the bring network. and

make information we'll and that RP patient the a some the way to we're that to to to the get also improvements it. So going now existed, never surgeons utilize ensure of a on have has further biventricular

that good and work We the final of appreciate to thoughtfulness in So CMS. things they put with the happening the rule. lots

Anthony Petrone

sense like It PROTECT XXX That's very X,XXX a U.S. view on you're helpful. a over be timing. broader And patients, looks just on IV Europe, my in maybe and would here follow-up sites targeting

I a And Gregg me He PROTECT Stone, the enrollment. operate complex more the mentions lead obviously is cases on there on want II to revascularization. atherectomy And Dr. was design, the sense the maybe back a to perform more of when looking goal it question So here just PI. to rotational then Mike, brings arm. on at timing complex get and

that so based sense And on the as can will give Thanks. a of and underway? sort specific how there of gets you evolve if sort us be study will surgeries cohorts

Mike Minogue

timing because get few want away right the with we vaccines. the timing, Anthony, now not PROTECT giving to So, IV we're transition study specific the a from just months

on last the study. have year. a in did Dr. Simonton detail We described it Chuck webcast

balloon PCI do the patients they pump. get think give details. design, and the patient these our or which out combination that's they they the because stage more the They on contrast of where or up don't your or things acute worried where collapse, which – get limit in approach balloon page, the the majority So and will is off-pump stent they're Investor quickly as of the otherwise specific a injury. and versus the supported on they question, of Impella an the is to actually about has physician still kidney inflate replace But PCI, we'll it or on-pump PCI, hemodynamics to today a

out. presented other that a is in option RESTORE events quality or patients ejection they that with gets revascularization, patients with the get not And hemodynamic they recently, So that's also improvements in in these the been that partly today. these why PROTECT are the provide support, Most of showed showed they it's significant Impella the the fraction of and able showed be balloon Impella will it adverse don't XX going of patients That's something and in we've and demonstrate when people with the at on is study there days. if lower pump complete What these EF that they life necessarily use for to to bleeding. use that III patient trouble. majority patients the was because know and have support many to will today today PROTECT II studies

get And physicians are where a less also ischemia. So doing we've the seeing they closure. that's job on patient. better did the do clean that, you what that But the leaving for made really progress a when we're access great In is benefit improvement past, they're the taking EF flow. and an rerouting CABG see because doing blood in does vein the and

the improvement surgery. recovery there open heart for But price sternotomy an pay to the the a in and there's is and EF. an pump run with So

failure to end, of really we'll life, that terms will design. EF. study. in very is we in what what that improvement And work trialists, able out comfortable there, failure, a study it's feel the quality heart we're be and the adaptive designed – that their study very to are readmissions, excited we the track in And network. an patients to it know And this on of physicians But by heart will and so comprehensive have here an with is everything going label the is a design referral excited have they're – this

and get there these So patients. identifying out start to we're excited

Anthony Petrone

will Thank in I queue. you. hop Thanks a lot. back

Operator

you. Thank

Our from of question Chris Stephens. the next comes line with Cooley

open. is line Your

Chris Cooley

XX% X% in question and about about a you're start Good you've in performance? and very questions. you when enter, it's how your unprecedented finish morning but and thanks and I low could You and very through past, strong the us a could the decline maybe sequential in also markets to place show and we patient see And sub a typo, walk for Europe XX%, a just the to bit Japan. new on opportunities. a updated growth taking recent congratulations a But I've sequential think the of the international us quarter reconcile still revenues. slide In expansion market penetration, maybe with little rates X% revenue if just sub taking on year. potential you international realized on most If Japan increase that

quick you I've could so with So maybe help you follow just up. a Thank us that. then much. got And

Todd Trapp

question. the for Chris, Thanks,

really, was as grow opened sites part did Obviously, million. ten of this didn't I'll we simple, in we quarter. up up fewer is Patients performance down terms the this over the $XX.X the Revenue XX%. four sites very function for sequentially. the quarter it – what well of about much, in to quarter versus in terms It Japan Japan quarter. Japanese In And continues was the perform take is in last fourth first was year.

I think quarter. it was last XX sites

between And would revenue really disconnect a what's a Japan. bit little in driving, that's so say, of I in patients

very overall, So performance, strong up XX%.

Now countries your around just question outside of… was second

Chris Cooley

Yes.

Todd Trapp

Yes.

Chris Cooley

– and your thoughts kind about was just on there yes timing. curious I of No, I markets incremental

Mike Minogue

Chris, is study the as it is much a a as IV PROTECT European U.S.

leader academic publications had trialist. and co-PI recognized from strong We've Italy. is the So and an growth

data. registry with that the active high-risk last the – of very recently interventional complete So quarter, by been showing society cardiology with publications, the Italy survival benefits the revasc. Impella placing before the and and PCI That's has and higher presented in was PCI achieving Impella published

likely be and Europe overall. We're seeing to to starting a many markets, top have interest will in IV. lift other these PROTECT of centers enter are expressed We in these Relative some of are also and the we remain enter starting Japan training is Asia, Impella on but priority, focus seeds. we into are focused And recovery. top centers planting heart again, Asia to in and – on the

execution be also global biggest there'll think lose to we don't and three but we remain Japan. there, standard So U.S., Germany focus of for the that more care drivers for want and our

Chris Cooley

one squeeze if And maybe I quick could just one here. in other

you it sense. States expansions the think XX United regions, from when about Just makes conceptually the XX here in to

in patients customer, also And Impella populations? more those more types greater better the of growth as a lift Connect, the want kind the us on Just similar seeing doing of They're get patient this to how just territories. you really visits. trends XX what Curious are – we kind both frequent You're though, shock to help kind in see you drive high-risk what helping in expand to closer the PCI field? feel understand out are Thank you. distribution as for seeing of is you there XX. from of and

Mike Minogue

the Chris, out distribution our happened design really is of what's the of and COVID part playbook. there

interesting And centers, that we're did hospitals. the that bolus see and not dip year, flat they shock going those COVID the on May patients to or playbook; PCI down fill out shock or on you embolism months that, flip and in track the and XX ICUs had XX look and months high-risk of smaller we the growth, They April, positive back do That and of were and the our records PCI if we tracking pulmonary last down because and shock to to and – of up, double territories the If at is, they recovered, eight in two patients and COVID high-risk most patients. of center. for larger positive hospital's know The kind a in first patient the capacity, a patients of itself But the in ever the were and last this a then to between then our element is forth the had six Connect. set the the two digit. means months then ever, that after shock go but most hub at potentially weekly refer ECPELLA piece So playbook. we're this, up. of access most that ever. QX. big But that delay set that part things have spoke, high-risk March, we bit records much cardiogenic and as that's and do of PCI Impella We they And ICU we don't mentioned, see shock come back. we've patient midsized will patients of as

capitalize on we think that changes made we've this like the distribution we we the and opportunity. to playbook works, hub-and-spoke really to So network, and like the

Chris Cooley

Thank you.

Mike Minogue

Thanks, Chris.

Operator

Thank you.

of Piper line Matthew Our comes next Sandler. the question with from O'Brien

open. is line Your now

Matthew O'Brien

morning. Good

of are Just on products right a helping kind couple questions I of some now. think business the that

seeing I to as a see is, little can starting access a just back what going forward of on CP what what getting a helping Impella this bit of then the digits the to a I think to kind little But few double in or Is But or bit of the is utilization guidance, And is timing have for and still things which some here and sheaths versus them things the the X.X on clearly up of help know among that targeting access CP? of accelerate as are business weeds it? kind you is expected the to maybe business getting bit, of you're of the accelerate is low far is of of which get down really adoption months? Mike Because hopefully trying sheath the faster. little starters I'm it then kind One centers because for to more? at here, Todd. this what's side sheath good to

Mike Minogue

complications quarter. XR single-digit We and have the Matt But Thanks III PROTECT closure priority the And did the we answer showed questions. CP. our do last comfortable larger short the users do today. of for low bleeding. have very with and U.S. it X.X, in volume is vascular the Sheath for access are cases is majority the the we on

in lot showed STEMI choice in also that FDA by We has a of the been the and Europe do now study. is that of also the The most physicians DTU approved access single means the Impellas.

they so comfortable have with like They're CP. today the And prefer access much single and closure they'd to access.

what in So XR CP augment with coordination are is have submission the the also we we're that. product doing a PMA adjustments minor supplement. but with to which is require but to XXX(k), a you that We're Sheath, will that, making some

techniques, really the confident new So preference going is we're also that's fiscal where top new our of this the centers. of are the the access seeing that the single the the we part think year. data we're But to we're clinical just end that by of and have pretty aligned two momentum

Matthew O'Brien

can Mike, product Okay, clearly here to that other sites right the were then getting some in X.X and entirely CP to And X.X centers okay, seems patients Abiomed that seeing X.X, you some was can QX. a sites X.X, over makes fiscal – among well I are use maybe well. see a of acceleration then it tailwind like shifting But nice the use it And the sense. weeds. is available clinicians again, those other XXX is tailwind were in for sites now then using the an or or into is? saying, coming access down that getting Are we're the it as procedures, which how unique over they number now. to know works I sites in using of more meaningful see how products and And and starting there the before?

some growing entire So we throughout signs of center? getting because are any momentum of kind an X.X of

Mike Minogue

bases. Matt, have it's is customer – yes, but remember, different the two you answer

well work call together high-risk two this what CABG. in that have shown in the they're between inherent have all You and heart interventional work then And the we revascularization. hybrid still we've together, And the and aligned well certain lab. something work cardiologists. cases. you They together the there's PCI But competition surgeons high-risk they because in is TAVR

So that the PCI, patients, for as patients CABG, by go we identify of these Soltesz Impella presented from on they and high-risk they of utilize these some approach use. Ed for where high-risk Clinic that these was Dr. some go Cleveland patients

EP left intervention the ability they'll still the acute patient, if is patient their going before ablation, they Then longer the where they need off certain those the see support no optical ideal VT need cath chronic an the patient. through attack to lab surgical first And the AMI is, the do but the patient heart lung VT is to function patient, whose cardiologists, X.X up. a quickly in coming And what and CABG primary chronic shock if the door to for for are cases, they as they In Impella the is do they it by with to machine. of also to kidney that is different the protocol, go lab, this in they'll leads But have lab, they'll patient, than on still the is stabilizing the a protocol PCI. That's and do time patients, put there's that ablation them presentation some heart they Impella is establish They Impella pump That ventricle. a the gives that to suite going driver. they into the use on symptom us the the in balloon sensor. do cath shock. It and acute the the going CABG. weaning. take revascularization decide pressure then happening the X.X. It's has in done And X.X they to what's be

home the the because allows still it's So make of invasive, is own the to patients but and ability of driving answer us most And not with send the maintain heart. least and to the recognition the only provide it approach alive, unloading. we patient path their sure keep that short take cost-effective science them yes, to a

see is surgery, failure The Chicago, on revolutionary the the heart across LA, Clinic Cedars leadership board. some distribution. and company Cleveland And the in to really And the we're X.X out added the teams excited by on product people really in in heart for a so failure. we've

a and and it's a continue because send but to what runs So purge. the heart without a we the BTR now have what Impella failure really and recovery, to changing patient X.X pump different mindset, are longer will we'll have that ability even enables heart it's home now

Matthew O'Brien

Got it. Thank you.

Operator

you. Thank

question comes Bedford from line Our next the with of Jayson Raymond James.

is Your line now open.

Jayson Bedford

morning. good Hi,

a Just ones. the of quick couple the of realize hour. at top I we're

X.X. on Just

XX% is U.S. revenue, of So days? is if X.X X.X these percent and X.X what

Todd Trapp

don’t It's Jayson. say majority it's in is – X.X. probably me. I close the percentage of over the would over – to of have it's business front I it's now the XX%, actual –

Jayson Bedford

international comp Thanks. Okay. could guide, about obviously has which XXXX. fiscal And much just then in talk you the if expected the wondering U.S., the on growth a easier versus for

Todd Trapp

in do obviously United States, expect the growth, to expect the little high-end Obviously, we do medium regions, surgical Germany. double-digit, world to Japan see double-digit when the we and faster with in U.S., and think growth. at business. across of growth at of whether I low, mid-teens a our going you is to see be of it – all rest nice look range, it look the even by bit you a three driven growing lot But the OUS

So it's pretty all I regions. evenly across overall, distributed think, three

Jayson Bedford

Thanks, And starting trial? of RECOVER just Okay, terms Todd. quickly that's in IV we where are with that helpful. Mike,

Mike Minogue

the what's details things in C, a patients a XXX is survival really XX% it. that very, think tried XX% you the which randomize, shock survival. through presented had cardiac the even interesting we've Executive survival patients of as We're kind the the we classic got of in in Jayson. positive arrest is Class on a the We group. now. status looking C, We've very very can but summation have which with to the the It's presentation Committee, of of is some NCSI We the yesterday, working that past. We're at final specific some And know, the we satisfy consent. around the difficult population

information. the So We're we do challenges the amount working we'll consent. of logistical have through and how a tremendous now

we following end difficult recovery finish XX% expect have very the the practices the the the of to more and higher population, start survival it than is for U.S., native in in Japan, but we really Italy We confident year heart for having the and a this that formula and But year. now best the type design this Germany with of study patient. with feel

Jayson Bedford

thanks, right, Mike. All

Operator

Thank you.

the with from line Our next question of BTIG. comes Marie Thibault

Your now line is open.

Marie Thibault

Thank for the you taking good question. Hi, morning.

comments XXXX? your you made Just a that I the confirm. we teens We Is quick U.S. to I year-over-year. gave about quarter, here know you patient Jayson. always of to that guidance to like the about us for think one high up metric, follow-up if midpoint the wanted to XX% right fiscal to to on see bar think and this

Todd Trapp

Are U.S. you a prespective? talking from

Marie Thibault

yes, Yes, the U.S. exactly. patients,

Todd Trapp

say would would teens. in somewhere be mid patient I utilization that

our sense makes guidance. based think it I on

Marie Thibault

Okay, been sure. you've of and the confirm, there. back given benefit wanted seeing Yes, some I I into to ASPs that. higher just

too you've feedback. be to whether here. up as questions. revenue heard it included that's think whether And very this then hear quick meaningful to Thanks we fiscal Breethe, we've something a taking of any Okay. see would can getting years. but good I in for love don't follow that much a I contributor seems XXXX, on

Todd Trapp

Good question. Marie. thanks, Yes,

had patients. now, sites – launch. about five I it's great think impact, We right of in been XX meaningful treated over terms a

I be that think XXXX, that about. will about it controlled think as somewhat you of talked we've rollout fiscal year

again, and focus more training So and, patient outcomes. on importantly, education

going think a So say us we'll the continue XXXX rollout. more on from probably controlled we perspective, I'd to fiscal big as a to picture, story. not impact year have it, probably revenue it's of a And about material do a

Operator

you. Thank

Our next Furlong the Cecilia question Morgan from of with comes line Stanley.

open. now is line Your

Calvin Chu

taking question. for This on Cecilia. is for Calvin the Thanks

Just two me. quick for ones

Do The could the full STEMI strategy you your DTU, remaining kind anticipate pace what update XXXX and the share? in just just you – of going with can is us give on M&A on us that much. of XXXX kind front on you enrollment an And to is thoughts extent for first – second of is you the FY on your be? active to beyond? enrollment Thanks timing could so on been on has what perhaps share

Todd Trapp

to will and With said, in core the continue our top I if at for groundwork deployment take? cash want take Do look remains you to growth strategy, with priority technologies regard we'll question first at you I that to opportunities believe new M&A. growth. lay competencies. sustainable that Obviously, look our think the we investment organic

monitoring. the last of companies. quarter, have will differentiated And continue our As $XXX for again investment in we over we still XX to balance that a technologies XX improve can in little million roughly to on sheet look patients, patient anything outcomes, ultimately, either to our Impella cath access, or can looking increase whether lab, utilization, the around ICU additional we're for and But technology bring value closure that CCU.

Mike Minogue

in the STEMI we six enrolled in enrolled DTU, on QX, added so QX XX in sites hospitals. we Calvin, and patients XX we’re patients at not XX

Calvin Chu

so Got it. Thanks much.

Operator

Thank you.

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

is open. now line Your

Danielle Antalffy

question, actually growth. just and it’s for taking to the a one Good longer-term much morning Thanks question. so have I guys. tied

XXXX a to today. know But give guidance still fiscal appreciate facing level, the going some comment and I if guidance not fiscal XXXX is you that. So high you're XXXX us and comps at today. I with recovery you’re fiscal qualitatively, could odd things giving like COVID

we about folks time about between it as we term, high-risk Or of longer if the see the you cardiogenic know underlying next or with to the PCI acceleration? be that’s Should to – impacted I should and look feel answer, call deniers and, do helpful. data, qualitative know year, dramatic don’t of what’s be AHA that guess, progress way that the I of sort line we sort shock them any So you profile are it’s really but growth difficult some company? underlying end were thinking of now right growth the the like making say, in guys by to think too volume? this comments I among even would

Mike Minogue

we level, last XX new profitable we have indications new existing been products and one for the years. stronger our medical Abiomed and think ahead countries, would I guidelines of growth. And decade at of expects products, existing a between high the indications, a have to companies, X.X be say fastest-growing countries we Danielle, and existing potentially and in of new device us

Danielle Antalffy

much. Thanks so

Operator

like Mike There questions. further you. Thank no the call now turn would over for to are to closing Minogue remarks. I

Mike Minogue

the for everyone, Thanks, time today.

any great Sorry, questions, it went over. day. If follow-up there’s out to reach please Have to us. feel free a

Operator

Ladies and you gentlemen, your call. today's participation. concludes Thank conference for this

You may disconnect. now

Abiomed (ABMD) 29 Apr 212021 Q4 Earnings call transcript