ABMD - Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Hello, and a warm welcome to today’s Abiomed Fiscal Year 2022 Fourth Quarter Earnings Call. My name is Emma, and I will be coordinating the call today. [Operator Instructions] It is now my pleasure to hand today’s call over to Nicole Nath, Head of Investor Relations to begin. Over to you Nicole.

Nicole Nath

Good morning and welcome to Abiomed’s fourth quarter fiscal 2022 earnings conference call. Chief Manager, Chairman, and Officer; President Trapp, President Nath, Mike here and Nicole Vice Abiomed’s Minogue, and and is Investor I’m Relations, with Todd This Officer. Financial Chief Executive discuss review today’s morning’s for press in highlights, as Mike and will The results fourth Todd which format business will call quarter then this financial follows: release. be first, will our and outlined operational were call After to will that, the your open questions. we

basis. financial During be prepared our information results This in the presentation the non-GAAP we not information for results on call, your in substitute accordance release. current a tables accompanying of with additional should The are presented our non-GAAP certain provided understanding between information enhance discuss or performance. to in of non-GAAP is this considered earnings a GAAP. as will and overall to results or superior Reconciliation financial isolation GAAP

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

Michael Minogue

despite QX with and a record record hospital of shortages. up in Nicole, note, U.S., Abiomed fourth growth a following growth a last morning, labor a Thank XX% XX% quarter this and revenue To company quarter, Europe the revenue, quarter record and and In the million QX across last record good you, year-over-year, Japan. COVID year with everyone. with XXX delivered XX% was record

than patients month, executing Abiomed in ever record X.X our more March, In playbook. we supported reaching revenue another before addition to by

XX% XX%, For delivered We operating revenue delivered record million fiscal XX% of from while in XX%, prior XXX we and results up and year-over-year to year of revenue, environment. in development, research the yearly XX% full an year. challenging gross investing XXXX, growth and in the achieved top-tier of margins margins X.XXX increase billion a

in As a ongoing pending. X,XXX result patents patents IP increased of Impella our to our investment X,XXX portfolio innovation, with

and at innovation, Our balance strengthened sheet we In maintain strengthened debt, advanced XXX in we ended also funding strategic for approval commercial fiscal while countries. record evidence, year cash levels in million clinical and Impella regulatory premier invested received the three Abiomed XXXX, and team. with investments. further multiple technology in zero year Operationally, field our

device the the Category Impella of with the Society B shock We of European Cardiology. for are upgraded patients Impella and granted cardiogenic designation guidelines and the for FDA breakthrough ECP Class saw the from to treatment by IIA

kidneys, the the caused we are health to At by while lungs labor We hosted enrolled Connect. XXX and U.S. cases and sites XX also their study, become these RCTs feasibility source platform, shortages. variants patient our grit crisis of care accomplishments disruptions to minimize the during and year of dedication. I’m training on remained Abiomed X,XXX and launched customers initiative, XXXX. person, in of helping trained care and therapy CAMP a interactive our customers Impella generated course live in in COVID XXX global proud publications, Europe are company. has our the with globally support. and XXX PCI, circulatory early XXX added impressive world-class Commercially, They through over for standard heart, solve Abiomed, patients opened and to our helping to and over the we fiscal and for Impella for employees hospital employees awareness virtually

our For year create field XXXX I and and strategy of our and today’s goals. to fiscal will leadership heart call, highlight recovery the innovation

pipeline stronger. portfolio innovation. our on ECP, product never newest has first, Impella Impella been Abiomed RP BTR. I heart will on The pump, Impella So and and Impella cover X.X, highlights

expanding we can number increased utilizing cath of patients treat the number technology lab, suite the conditions are as We and simultaneously surgery ICO. a and in our physicians we of

recently the embracing year and first surgeons who announced X.X a our procedure to X.X this with smart Impella is thanks world. First, when that recovered, assist the but technology XX-year-old cardiologists shock, cardiogenic in transformed with Japan man Impella suffered the grew in around Impella failure an Osaka are heart breakthrough XX% product heart the and relationships We at Hospital the X.X.

X,XXXth In addition, heart transplant. to we and Hospital SmartAssist Tamer an shock patients helped milestone with cardiogenic recovery. able Impella Impella heart Impella with bridge and X.X cardiomyopathy has would woman her changed in Connect for Dr. to treat XX-year-old support a to how Atlanta at X.X otherwise we have of are University less used and Impella option when who our Attia cardiomyopathy hit Emory successfully

PCI French as in other more III Germany enabling papers and Impella an I, enable XXX,XXX ejection shown X with procedures allow ECP We or also EF, disease total other supported announce BTR, RESTORE I’m invasive, provide To as is to of goal billion study, that to additional currently to studies this breakthrough over BTR on with for another now critical a Impella technology. will their revascularization improving Bridge the PROTECT physicians may heart of in based Abiomed the Between received well Its market a is more heart an PROTECT Impella addressable happy II, breakthrough parts or function, feasibility, and pump Italy, first technology. BTR the Impella projects home $X X.X flow, with approval and discharge patients IDE and minimally Europe. and the smart one-year. being patients. fraction PROTECT provide complete to patients early The of forward support potential ultimate U.S. FDA and artery hemodynamic size and enrolled Impella Recovery, safer patient coronary durability

investor investor now our website. reminder, Amir a Chuck As including ECP, our presentations Impella on Dr. Simonton, Dr. available and from on event Kaki are

support. Earlier Turning and in next Impella SmartAssist with This to sensor the in capability. winning of heart is technology right with the the dual year, we our U.S. device RP launched generation FDA-approved smart the pump exclusive heart right

and on which and Within in while IJ RP interest heart support, called clinical data. is drives to innovation technique the preferred and flywheel, energy our quarter, patients products, Like jugular This ambulation, and from a through we also improves insertion or PMA thus the outcomes filed and surgeons. a insertion the for the momentum vein neck. up excitement allows with get walk by also the supplement their Impella internal in our

guideline. X year, receive Class be acute including over XXX,XXX We a staged trials are PCI patients lab for overall kidney and the with will exciting multiple cath DTU. or success have injury PCIs foundation underway, in not most hospital Each clinical IV incomplete are or extensive done cath PROTECT ever suffer study or the just on in but the lab, IV lay and are revascularization readmitted will there XX-days. the within the STEMI for that high-risk to on PROTECT PCI,

to turned disease CAD Failure, in highlights authors onset XXX,XXX patients that after during Circulation opportunity new found coronary in PCI. year coronary not a medical or study appropriate down testing patients artery over of optimal to an In this an XXXX admission. therapy heart before XX% referred the were reviewed either for interventional and in with are not Heart data for and patients for older there for that did revascularization. receive index cardiologist each published hospitalization This artery condition CABG or or with hospitalized surgery testing failure and care disease, identifying Additionally, XX-days improve U.S. by the the in candidates

improvement quality our an and data We XX-years PROTECT efforts of generated years can for U.S. opportunity from relatively average, a on benefit IV PROTECT that believe $X PROTECT young reminder, from Impella-supported with a and II in high-risk direct billion and opens market life combination educational As in patients fraction. with improvements up PCI. physicians to ejection patients, ahead III so many old, are the

Finally, of for to XXXX. highlight fiscal our some I would like goals

First, smaller which clear, and majority. To improve lower with we and will is the they bleeding because innovate to to use. outcomes utilization, devices increase will late reason important of we of be smarter believe vascular complications, continue are and risk connected more devices especially the the smaller, ease Impella

ejection like Second, of STEMI fraction key physicians their a with evidence. Pivotal, EF plan enrollment out techniques and XX-days. our III in DTU, prospective and proven outcomes PROTECT and expertise accelerate and add new publications of last, to EF III in coming extensive we RESTORE in the in with demonstrate And PROTECT Impella COVID, prioritizing tools an improvement field to their clinical that clinical database with ECP IV. clinical leading that allow for utilize the that real-world PROTECT improvement at studies, RESTORE

commercial team, with and patient excellence, engagement identification FDA-approved Lastly, indications. multiple the we including remain focused heart physician on for education

culture patients-first remains our foundation success. the Our of

and Dr. and Little severely support like Medical identified and before he Arkansas his at by be his and He support. When implanted Bobby to allow in heart in men’s Impella home was to care. representatives back able he with teams Bobby in his evaluated unit condition league. cardiogenic and father, function. family days, the Bobby escalated heart called Vincent Bobby’s a of at sales active is can from breast and three was right Bobby experience of concluding, enjoying weaned Conway, an his found ejection his tested with fraction local children. within heart low condition. share XXXX, on his in normal to and Rock, softball on time the patient while a to home, Carlie in shortness myocarditis to riding January removed. wife Arkansas X.X ambulance working eight weak. XX%, husband Bobby Bauer for He days, away physicians a would a returned was hospital. his pain. COVID-XX was shock to chest Bobby I and He life-threatening walk bikes Upon So below story. XX, playing transported Goins, today for was St. computer After positive early to and lifestyle. to has it transported work lives determined and is his kids improved, Impella was and not Bobby due he severely arrival, Impella their that rest. Thurston XXX. with

meet Abiomed year visited Abiomed In has Just story employees our Annual flywheel recovery as speaker April as guest Global to condition, I months he Meeting. Company of we life-threatening as early fiscal start in our the a XXXX, to share got at after this conclusion, all to momentum. headquarters Bobby heart

never Our better. been innovation has

we established, commercial the have evidence and is premier organization. clinical Our

patient now improving fiscal X.X as Abiomed outcomes the XXXX. the Todd Our on playbook being to and of employees leadership and execute and thankful and and adapt manage us standard dedication turn year of and I to customer’s our goal will our global over care. allows CFO, we call lead during Trapp. the I’m pursue for focus courage, ultimate

Todd Trapp

XXX QX, of you, reported on morning, currency Thank delivered and in million, good the prior everyone. and Europe revenue double-digit up we XX% across constant XX% Mike, growth versus Japan. year, record In basis U.S., with and a

patient were we by U.S., saw PCI million. and mentioned, As In grew labor increase to on based revenue these in X.X we cardiogenic results due by XXX shock shortages. executing an patient the utilization. performance the as to ongoing despite Mike milestones, Omicron innovation, achieve to and and slow High-risk a XX% a our able X% was clinical our to the impact Abiomed pandemic grew variant commercial hospital X% January This utilization driven deliver playbook.

our saw in with as performance on quarter, positive and a the we improvement revenue impact Within delivered monthly playbook we patient months and record cases declined, executed in sequential March. Omicron

with surgical had the revenue continued growth quarter U.S. by with for X.X strong demand SmartAssist. another Our XX% driven business Impella

of the CP the X.X in QX, U.S., XXX fiscal of Impella the sites. in is end sites. Impella is X,XXX The in As

prior versus While the Impella X.X the up sites XX XXX quarter. is sites, now in

sites. XXX Impella the in RP is Lastly,

per the deck. U.S. the As details of with investors, summarized average site, our at performance are in inventory consistent quarterly Impella in hospitals units quarter and combined installed XXX% Reorder an reminder saw X.X was the QX. slide product in CP with levels slightly above and a the our base we inventory to X.X for

year was up QX, in the both total versus outside XX% Europe XX In to prior in strength and million, currency Turning revenue constant due to Japan. U.S.

up Italy. million, was increased This revenue constant record European solid in driven Our to XX by currency. a growth Germany, XX% in Belgium year-over-year performance and

delivered Impella currency. primarily transition Our up record CP a in with to Japan, XX to from European million, XX% see positive the SmartAssist. business In constant also year-over-year a we benefit sales of revenue continues mix from quarter

headwinds, of cases during total year. in saw hospital As opened the versus growth four we Japan put patient in call, sites Japan In restrictions we these the levels record new in business and in XXX. Omicron last were month XX% our delivering resilient, to utilization place. our escalate to sites mentioned January, Despite bringing our remained prior quarter,

was Moving diluted team, $X.XX prior XXX performance quarter technologies income XX.X%. Breethe, Non-GAAP advance and totaled The was in strategic gross due and IV The $X.XX evidence in continued to to Impella In net was non-GAAP our QX driven clinical margin production million, to to versus from operational of our operating lower income quarter and for up the year. we R&D In Impella prior XX and per million operators growth. investments SG&A or XX was compared by our higher patient X% grew to flow year. controlled support the forward, and margin XXX therapy approximately versus year for of offset XXXX. flat Impella STEMI RP PROTECT QX, campaign, in BTR year. targeted driven rate. prior which preCARDIA. investments due trials cash the by XX.X%, randomized expense million of a XX our the our investments of for translating IJ, million, tax to million to game-changing an increase effective through XX share or XX to million generated and DTU million, The the QX increase X% increased XX% increase volume expense for increase operating totaled future operating distribution like an and training X% education. awareness quarter, ECP,

As investments. million million no year fiscal strategic XXX a year, result, in cash, while XXX multiple debt up XX% we and versus last ended with making or the

full-year to our Turning performance.

of equates revenue XXXX, Throughout records operating and By for exceeded despite were the guidance. which grew, million, XX% XX%, to For XX% Japan income fiscal of and set we the high out quarter of compared a the headwinds. ongoing in geography, year Non-GAAP our and constant billion, X.XXX was XX%, year, revenue Europe fiscal to year grew growth we double-digit the revenue year, quarters up deliver the the U.S. respectively. XXX revenue currency, XX.X% four margin. three to while end operating delivered year-over-year, XX% which up original able each in prior

building in As team at invested of the we year global we care. in becoming goal to year-over-year. the in standard year, will our innovation, of up XX% said beginning continue our research as fiscal R&D, XXXX, we continue to premier distribution investments In and of million fiscal be we clinical XXX a pursue all-in

the million for million year. prior our our to campaign. Additionally, launched to we in XX% team per heads and increased awareness added $X.XX XX versus XXX net patient Non-GAAP income distribution therapy XXX share or or year the diluted $X.XX

XXXX. Lastly, turning to guidance for fiscal year

constant XX% in to the earnings expect range growth. release, to in XX% morning’s in be As full-year we revenue of currency noted this

assumptions material impact foreign will XX% X.XX, our and have euro waves in state at rate percentage This business. assumes on to that more impact reported approximately future to do rates by exchange reported rate a a X.XX growth COVID that XX% Japanese a guidance the are Our to at This endemic and two year-over-year yen growth an points. not which translates on moves the basis. forecast

of the In issuing team to finance had annual year typically the in-person our expectations came our we and QX, together fiscal some to on provide As to I would extensive training. celebrate when do guidance, year. color our like seasonality global

QX vacations fiscal their busy in take after a to tend also year-end. team field Our

XXXX expect around summertime up the a cardiovascular QX a the vacations. we result, devices to for physician XX% on As quarter slow constant be currency. million, XXX QX slowdown is lab and cath seasonally in to due

typically fiscal In end see QX, So as activity we based best be our a and QX, and our hospital we or lift expect to increased physician our year. we engagement revenue QX bit pace. the results over we quarter, at have March just significant on in sequential little

Turning to operating margin.

and year out clinical Pivotal, company including macro key DTU we advancing to to fiscal fiscal significant for our despite IV, on expect which margin We focused conditions. in Impella year remain year evidence, XX% of and a our XXXX, enrollment distribution premier we innovation, to record accelerate in studies, range a STEMI as building In investment. team. PROTECT XX% year ECP was In be the clinical will XXXX Impella the drive summary, tougher-than-expected of our fiscal portion XXXX expect

during second delivered year to have XX% growth the a top consecutive line over pandemic. We are of pleased growth,

top-tier Additionally, a continuing forward look new $X We to and robust we increasing the cash recovery. field year non-GAAP necessary billion, clinical to the of for all please and as innovation, evidence achieving growth. remain driven our XX.X% questions. position disciplined open almost we new drive long-term to Abiomed’s investments by the operating sustainable margin Operator, execution continued make line fiscally now of heart to while build

Operator

Thank you. Please Matthew from Piper [Operator Matthew, line your today open. Instructions] Our ahead Sandler. O’Brien comes first from is go now question

Matthew O’Brien

Great. taking question. Thanks for that

maybe OUS? Harris a and or of year the the is Todd, the a at PCI? for better you on more like Just are to expecting cardiogenic than the a see. little or great for starters, think components it bit were most currency pickup between And I year, It talk bit a more people X.X saw primarily expecting we growth U.S. on shock things. constant about is side little still Can guidance this driver we

Todd Trapp

Yes. the question. Matt, for Thanks,

distinct buckets. three I year growth really year initiatives our categorize this would fiscal into XXXX So in

our is business. core First Cardiology U.S. Interventional

training half, about direct-to-patient our pick up this in expansion, RP our distribution the more all our setting. RESTORE and expect publications, education benefits especially and team example, second growth And a and the revascularization see So we around a complete in products. for PX clearly that and campaign, highlight in area, single just the clinical you EF given CP think initiatives to of

and business. year continued second year like our We some fiscal Bicarb sites of or you second Again, our years in pillar business, the expect X% X.X XXXX. XX%, are I U.S. in fiscal if growth also surgical we Surgical around ECP surgeons demand is half in of new from really grew suites the say like four was XXXX. it remember, and is in pump and about have the three some the of and today, X.X RP enhancements hospitals for And IJ products the that Breethe only close year. ago, U.S. XX% our to of we the And of in the about XX% with and strong would XX%

So we usage more is then OUS. I up expect say, to And pillar surgeon and third per of is increasing. sites Matt, growth would open our really

XX% to today, our so the is and close than And of continues grow to now it business outside that United faster is U.S. States, the

we so our penetration rates products, as growth should are which our augment existing within continued rates. given launching in Japan, low And as penetration help Europe in X.X and well

the initiatives. So more of end the the of in in course high assumes the and the a low traction growth earlier over range at year the from factors end these these pace measured year, initiatives

Matthew O’Brien

you down start aggressively. come use have lot different a to Mike, were break you that barriers in board made to - momentum with Got of it, the And coming. product now Abiomed and you. more thanks caught to lot my momentum breaking that. Are start of in to attention. on Thank starting a you got products more on I’m you flywheel to are significant historically wondering, using are see starting just for and you centers, opposed clinicians down comments then

Michael Minogue

International myocarditis primary a shock. cardiogenic or difference talking Lung high-risk is week, I heart are failure recovery. whether we been company, or big and Now, PCI the have have heart ISHLT, lot Heart, And which This about has acute or arrived the recovery goal, chronic it thanks and question. time heart for team is Transplantation, with at shock I cardiogenic heart and Site the today, attacks they spent a but of the of think from even is, as

And to City really New the all and ago. road on And over got flywheel, the what seeing South worked the also it West. is I on and momentum. most best personally, have momentum And month so in THD do we we fiscal attended to engineering. I And products have coming year, have this customers have ACC and have - York means we a where XX-years tremendous the the I get been have

science is studies we most the XX/X the that field Impella have bedside and a with premier And have in the best established this team support phone Connect. do on the in space We process. in and cloud

outcomes hospitals about our we labor So to with the we enable we for their better feel confident use can fact can very that patients, shortages. help also playbook

really So great for just company. the it is a time

Matthew O’Brien

Got you. it, thank

Operator

you Thank Matthew.

line next Marie open. BTIG. today from comes now is question from go ahead Please Our Thibault your Marie,

Marie Thibault

like so and thank early one It you the would the what And specifically recoveries, April. Yes, you to hear exited are how I procedure was far seeing so much. quarter, to more ask I the U.S. of love did sounded in sort soft quarter. that in high-risk the cases. was PCI on on what particularly maybe here that want more

Todd Trapp

high-risk is elective." when it to over patients it patient at hotspots these those into pick up, would last sequentially the January see and to highlighted was looked come hospital fact I that March, "truly these went are probably sequential year. perspective, these at aren’t Again, say And what we have the I the that seen the January, given back happened back essential. And that saw it, improvement PCI two years months. February They over our you you and significant looked again, with we in shortages. think of from when all two Marie, system. from Omicron the really definitely because volume we And patients last a was Yes, what if lowest, labor

February say, of our and the call, month system, to did them but come tough would is back absolutely late timing March. the I into we Sometimes in see

Marie Thibault

on And time hear. line. accelerating trial one to Great then Okay.

you are on people for potential a RCTs also, with willing wait Impella Are of that see excited larger term. think training, are that, the do any lines give ECP. for of the of and and obviously us thing the do running to learnings of Do starting longer We hint some the to or you sort time sort education that very field? that at two-parter effect are need you to out to again. those think is you into - Thanks that data already leak the here

Michael Minogue

better Thanks, fact wait PCI the for FDA, Marie, question. all relative the cardiogenic exclusively by data contemporary and I patients for The shows older, don’t forms are to sicker, are think to procedures, ejection a newer they they approved they higher safe people PROTECT having in bleeding having lower improvement fraction. their leaving need less effective is and and lower and Impella the ischemia, that complications, III the high-risk shock. are vascular are of that

and fraction it on improvements. ejection anymore I is think don’t debatable the So

symptomatic but at life. the ejection of see fact, publication. look if been is it stenting, how some we that including in relief, is in EF, RESTORE And studies been was of have you published also have on presented FDA fraction, earnings history which now PCI consistently for also an improvement demonstrate release. accepted studies studies, we In slides with we you III the you that improve quality abstract has an which and summary have their PROTECT multiple

of information lot be is a going very think that helpful. So to we

on so your of has high-risk over on the EF support patient you PCI insist is I PCI would research that think a or to improves. risk the patient of this And hemodynamic failure. that years that staged high-risk acute anyone have doesn’t so with kidney get why be goal or the done Impella, injury call any type having

And and going are so complete to improve your the and which revascularization, if are off to getting somewhere get then they not CABG, better are you going not is proven fraction. are you goal you going ejection to do

For are makes Hemodynamically, exclusively for sense. approved cardiogenic shock, it clinical that. we

Germany, U.S., and now practices validated published have been also best Japan. have in Denmark that in the in in Italy, We in and

the So medical have have in patents, approvals, working don’t we that for the we is The exclusive of guidelines, that we future now not premier the device a what of have a team. have at is exclusive those components FDA thing field only field but aware I’m are single we that has Class all one. I we

are the meantime, but validation that going our makes for bar these Class So from in there evidence effective. tremendous of for technology amount what them and the and that the gold is we safe X, FDA patients is for

Marie Thibault

I to ask. the Anything of have for course, ECP on good line? the Yes, there. time understand going Just that. medal for gold And

Michael Minogue

Yes.

that to in on So because opportunity we we also multiple to have is - did a summary studies, posted ECP. slide do website, the we have continuing we the are enroll

March, we the IRB to in the So FDA was March, IDE, protocol. was approval have approved now to sorry, the IDE have the for now get have in pivotal we protocol I’m hospitals do approval - this we to at the - get

final the the have product. We also the or version of latest

we the and But certain the to the are enrolling doing by pivotal of we up number and IRB amount protocol as going that patients in patients, So right patients, a are that a of pivotal to approvals remember transition we to of they not are will the go. now hospitals. study be that determined with the set outcomes

excited, an early it. are we us to transition we FDA the So allowing and appreciate feasibility start

program. a great I think is it

update are we saw give but for PROTECT we will had accelerated we weeks summary flow total April, hospitals getting enrolling. things STEMI two the And the best that stabilization in an the number quarter, a of the think patients IV, back we do pace. the once more give even we we that, think DTU and better every as little we bit forecast and also enrollment on both a We of And meantime, in are in where in quarter every sites. a at updates. momentum continue will for of give or But of get have study, the tie we will better out, patients and a

Marie Thibault

Thank Great. so much. you

Operator

Marie. you Thank

go ahead Please from now Margaret, open. next today Kaczor Our Blair. comes your William question line is Margaret from

Brandon Vazquez

just on of question. And for just to morning If through the maybe pretty today. would Good Thanks maybe go we talk topics talk what the are and could pertinent like particular, and second. in for macro This is Margaret. end of a taking high the everyone. end back, about you some guidance gets that talk kind I of about the for Brandon the low range to

have other staffing peers We medical have inflationary talked things have that. had shortages had about, pressures, like that device we

to issues the gets you to low and these some So play of macro the end into that high what do end guidance? how then

Todd Trapp

Brandon, the for question. Thanks,

I mentioned these on are after. areas earlier as we we that have So again going three

Cardiology We the traction that measured more these the assumes business, outpaced have in in over assumes U.S. high these really, come Interventional well our the the course initiatives nice U.S. the end have year. growth we our pace. as range growth we low to from growth continued business a The end that of as expect U.S. get in see the we that And some earlier on, at factors Surgical of core just year the investments

the and of direct-to-patient expansion areas Interventional more And mean, education significant the in investments over I you publications. so business, distribution more team I think about training would and our made of clinical and if say campaign core and Cardiology and U.S. last our XX-months, we these have

the whether So range And low was phase it is inflation? the end of end around, course your question around range. how we really more to around the think high was get I then second second question year. It in the we the or - your it of of over depends the more just on these

Brandon Vazquez

and with scenario of wage staffing, space impacting ahead. just just today, is the then inflationary the topics obviously, go well. staffing even the guess one kind dealing even because medical Yes. Sorry, even pressures, inflation I kind just the of in of device as staffing

So are is and how in just the those business impacting guidance? where the that contemplated

Michael Minogue

Brandon, this be we Thanks labor The standard. the is Mike. shortages, question. expect to for

running patients the as training have more first and then virtually. them U.S. then makes one watch can offer of CAMP lot to the can about extensive or support, independent our remember, we we productive. to which If we offer COVID companies for you The us a PCI, well, hospitals the of have live variants. physicians cases. And the we them, all in shortages, we labor talk bedside recorded productive, which we phone support do so then of have things cloud, XX% were the more XX/X they have it cases of But makes

shock We where training the a outcomes, have now to nursing and the over, and U.S. to are are are on continuing work with transferring has length publications the that a think, reduction seeing is - programs utilizing we because momentum shock establishing and I trend COVID partnership around I And especially protocol virtual technology. we us extensive they kind more work improvement of protocols - for are the been hospitals more see and the think of website establish with is what stay. we and there teams showing our heart accreditation teams in mindset there stronger and is, And really seeing of for staff.

Brandon Vazquez

last RP one it yes. one like just the it, ahead. sounds and for Go then of me, - in Got terms

Todd Trapp

just going was second was to answer your question. on your question inflation. That I

make a of on that. wanted couple So just to comments I just

reminder, But team before and working price to But they some a some raws up said, in increases in have seeing and some our electronics went the the pressure way, is logistics of we think in prices pressures, pre-bought have don’t areas. to sourcing looking we we mostly components minimizing increases, a have are that negotiate into significantly on locked we for pumps. to a the cases certain As actually are I price and overall inflationary effect. year on content our material high aggressively with

have margin for what So operating are the on as on guide visibility consideration our the I year that in seeing of we inflation, taken based some think today. we but well wage pressure see

Brandon Vazquez

Got thanks guys. it, leave that it and will answers. Thanks is lot I a of there

Operator

Thank you Brandon.

ahead, open. Our comes SVB question Leerink. your Please now today Daniel line from from Antalffy is next go

Danielle Antalffy

like Good really for morning strong XXXX. questions. fiscal everyone, great thank two much it year, had momentum into looks the going just you into taking and so Congrats I question the on

momentum First, keep manage at talked COVID hospitals hub some Mike, the about you in the the past, open. as spoke patients building beds have hospitals or

see say of can saw was just and anything growth to hoped As COVID the we versus you sustain you that Omicron in of one the spokes quarter off had the hospitals follow-up or business. came the see, then the the about the volumes in back quarter, as what the surges did waiting, spoke which are you sort hubs and cardiac on the surgery half

Michael Minogue

Danielle, larger way Also of sure based little thanks coming also COVID, really hub CMS coordinate a to centers to but of payment. network one as during actually transfer COVID bit is been established with teams patients because and picked hospitals benefit is to flow pace regionally the spoke. just be reminder, the The question. make That And smaller the the our for the of can our that great patients. midsized a centers. out hub And we it the we the the exactly is distribution from in the tended continue what we up see the in to distribution, hub established more last are COVID. that

receive Impella and spoke hospital put manage the the where of the So support, and receive management the compensated explant can explant XXX Impella patient, can patient and also of and the the accept that they patient hub a for are device and on DRG Impella the pay, an ICU. hospital the in

is regional So growth. very that it has our something it these is also shock importantly, in cardiogenic in outcomes patients. for But been improving helpful most markets

Danielle Antalffy

Got it.

take What years’ business potential to you surgery from so of on three in five years, during phenomenal business. look to And driver has I to then and mean, to cardiac with amazing been just a business just And the two $X growth cardiac do a the and has mix curious, It Mike, a the five on had here back step think things? as the side much. growth time Thanks the you business, I’m XX% see. pandemic. gone the X% years is the TAM, is that even it Okay. of be of over in last at the a billion surgery still

Michael Minogue

cardiologists in at the because don’t on ISHLT will you tell PCI I shock Danielle. percent, growth surgery Thanks, the high-risk being you, and look will I surgeons business week, and at expect all failure tell the heart to and definitely have significant it long-term is crisis, and or is on acute with chronic heart heart whether failure, is it with crisis, if BTR. heart preCARDIA failure this address and a itself is X.X failure a the which shock chronic that cardiogenic Impella, will or

up best what quarterly we the seeing are means. chronic these actual we One, X.X scale, Impella and you put how pump the patients. BTR with have So seen kind in slide series is have on we will see outcomes the it small and the a of

is the data recovery are baseline pumps, in kidneys We have are large we patients BTR smart seeing then two go these discharged. not And remember, and and allows sensors. the - to longer home term, percent a what also running their on up to to get pump, back is get BTR recover allow cloud, so give with have the and being the

do means getting LVAD. So the you we ventricle actual which the pressure with the able left any and are we to conventional back is scientifically, are in wean aorta, which heart can not

that transplant is get is and life not more of it these are XX smaller, to able So quality and back kidneys that besides to really and protect connected, their get are to it the smarter above is at a that fact to ultimate for baseline, them patients is home. the back go goal it

Danielle Antalffy

it. Thank you guys. Got

Todd Trapp

Thanks Danielle.

Operator

Danielle. you Thank

ahead is Our next now Bank. comes from question Deutsche Imron, your today line go Please Imron open. Zafar from

Imron Zafar

much very for congratulations on quarter. you a taking Thank great and morning. good my Hi question

question a guidance. BTR for I’m clinical First, in whether ECP and and contributory are revenues you regarding also from your have PCP. how both FDA guidance, had trial registry any quick clarity wondering access continued on

Todd Trapp

from regard in will in or Imron, really time BTR in at question ECP guidance. point in the I would guidance. factored our haven’t we with much a terms to take the I really of first this say revenue perspective

Imron Zafar

access clarity any Well, registry, Okay. there? continued

Michael Minogue

continue Yes. category continuing will The is as lock to centers. done early when access from protocol are reimbursable. Imron, it went pivotal which patients. protocol, yes, this keep B, feasibility ECP pivotal we XXX overall the will up into the We patients is product to to where so and happen treat we we we centers continue become down ramp at those it and those open then will or enrolling

but that So get priority a enrolled. we are the tail focused ECP we is of very the as when to end on getting enrollment,

Brandon Vazquez

you. And longer-term second thank then outlook. Okay, question margin around is my

current Thanks. dominating to or you presumably gross four your componentry on pump or differences First when ECP manufacturing like gross profile change out any years terms look like business margin percutaneous business? in think and should X.X versus things of the reasons there in to three current the that versus margin, any are

Michael Minogue

So Imron, out. just point to

a will Impella think access for the balloon in is those be XX-French Impella ECP what of uncomfortable many So eliminates physicians cath that these PCI the protected product we ideal the patients, a pump hole lab of on that CP. for an who with closure especially with catheter X-French likely are

think we the to going shock to expand CP Impella high-risk PCI. probably best to So Impella that is continue technology. help for use that ECP going patient is of be the cardiogenic

two where the has device a home. option and to four longer-term going up patient be goal for of a patient a discharged around five patient see best over gets We the is the be year that walks chronic can is X.X have course, that to then, So the the that or days of in to and ICU. BTR

a new cost the you roll always out, as bring as so higher. curve, products a evolve, you have to other So to your the products And bit little tend are learning the costs down. continue

in or see we don’t points or the are PCI But we high-risk in saying the we Europe. now one I are are U.S. versus Japan whether whether other. the have of So is cardiogenic we price change have ability as what I whether way to a in am parts it that versus shock or different

on the it best-in-class are shows of in is and last overall. and the that manage that gross our value pride this take going So as been, but top to margins, the XX-years, for over gross have the as we we in far way margins, technology we companies great

Imron Zafar

see by to some terms trials a in we When follow-up general? And Awesome. going multiple start fiscal year margin. at could Todd, investment should look on et and expansion, to in operating of on XXXX, sorry, I normalization in R&D given just operating this if expenses operating a then, be then, the year Thanks. we moderating clinical cetera. international margin is big going in ask Obviously, just

Todd Trapp

But will fiscal to I Well, guidance in I clinical think time, year down. moderate start some come when year at I XXXX. then trials fiscal these start look Imron, just provided to XXXX, and at for point

longer-term I of if Hopefully, look terms when so we to going of is percentage year back clinical be And to next it moderate And sales will in to year start to into post-COVID, And are the big will year, maybe year. enrollment able openings starting on it at trials XX% then to it close as XX%. come back R&D then be our of execute we and this get site that down. going R&D, a that, hopefully, a following or and is XX%, sales.

Imron Zafar

much guys. you so Thank Awesome.

Todd Trapp

you Thank Imron.

Operator

Imron. you Thank

Our next is open. now Please Furlong question today from from line Stanley. Morgan Cecilia go comes Cecilia, ahead your

Unidentified Analyst

as on perhaps have deferrable as seen, pronounced of the names we tech you what potential on in kind Hey Cecilia. protected for I’m sidelines, for much the more question. have not out. backlog cases back just is recovery? How med of that of are that in some of on benefit for terms on what here case do a potential This curious flow waiting you your (Ph) see thanks deferred just [Calvin] on taking from seeing to curious would the PCI

Todd Trapp

probably Yes. that saw we March. a mean very Calvin, I in lot come little. in, back would of I say

over So do have in had January. last And back back it few two seen we months. impact comes they next we years, in some the - an the and like come

say XXXX. year would fiscal into as backlog, opinion, get in I So we little my very

Unidentified Analyst

Got it. to I check ECP. also just in on wanted

government potential out there if of least probably years sort you have is until curious curious but road? I’m some hospital a just update, we at from ECP based positioning just the know versus approval, on see are you the early the how on stable I thoughts X.X models, any Impellas you. standpoint ECP So other versus pricing the Thank other profitability down website assuming reimbursement.

Todd Trapp

Yes.

from finalizing in an but what is initial going of CP pricing rate standpoint. still somewhere process be are it the sort of is, We to the the around

Unidentified Analyst

Got it. alright, thanks so much.

Todd Trapp

Thanks.

Operator

Thank you Calvin.

Our next Please Bedford is James. Jayson today now from open. comes go Raymond your from line ahead, question

Unidentified Analyst

[Pavan] ask you levels? it for about above March have is as Is of In levels. quickly international to assume I past, about that pre-pandemic the well. number have most above to mentioned regions that this that (Ph), are are on guys fair guys growth exiting centers. the I Jason. follow-up prepandemic Hi And centers of wanted a

Todd Trapp

Yes.

set that think sites are is this absolutely safe a assumption a We I record it quarter. in most above the now of right and are pre-pandemic we levels. in that revenue patients

this So in at above are pre-pandemic yes, time. we point levels

Unidentified Analyst

the And a FX Okay, higher headwind X% great. was thinking. bit were than we

that is you like can U.S. year fiscal that growth fair - we to comment international assume versus guys So XXXX? expectations on for

Todd Trapp

we importantly, Yes. rate I guess last - financial we was forecast, was But X.XX% X.XX%. up averaged year average. month it in last the X.XX%. of yen more went X.XX%. our on assumed then And I’m at surprised forecast, euro year, it to the did when the it Today, is where is X.XX% you is when April look X% big, because

euro against So significant strengthening and that. are pretty not yen in seeing the the we alone seeing and sure are dollar we I’m

Unidentified Analyst

cardiogenic shock, outside guidelines been ECS Germany have they of had has as updated on German or impact for just any Have the revenues a phenomenon? well mostly that

Michael Minogue

quarter the nearly Europe the for as So the of in Europe and year are for country every for record all guidelines set a and well.

guideline than it. that positive normal now medical likely some but The thing technology. for is is the a uptake is sign. it So It Class most there Xa is higher a not a is pretty only to X recent, and

Unidentified Analyst

something is And expectation for some is the that expect that kind like there that coming in that? guys years to time you it. or frame change Got of

Michael Minogue

based the our For X? Class studies, of That the recent is studies. on completion

Unidentified Analyst

thank it. you Got much. very

Operator

you. Thank

ahead Wolfe Michael, open. Our from Polark question from today go comes next is Michael Research. Please now line your

Michael Polark

Thank Good taking morning. for questions. the you

might work you quarter, a more mentioned Curious commercial you back think is when you’d for of your console ECMO an posture in on space? upgrade how Just a two last the platform. for and quick there, ones. to update be working going Breethe, the ECMO

Michael Minogue

an confident of IP, to are we this pressure And have allows are the we heart. product, expect the is very be remember, software about the For through finding we little pumping working coming. an ECPELLA, are electronics second some consoles in as already ECMO can actually the there we know the we which on Auto we feel we Europe, we outcomes, device clinical validated Impella itself, the bit are utilized, go for against half, some differentiate upgrading on that the to retrograde ECMO Because products VA waiting and a to positive more the so the ECMO process. back improvements device for Breethe is console making to being

hearts in recover are ECPELLA to we like lives, and and and but not and second lungs going lives. be we So between out coming feel to half, save well recover save positioned only Breethe to hearts the

Michael Polark

much. year is Thank this Todd, reasonable you guidance, for tax what models Todd. there. a you and rate and adjusted set input just for the Thank to level so

Todd Trapp

use for Yes. I would purposes. XX% modeling

Michael Polark

you. Thank

Todd Trapp

Thanks.

Operator

Thank you Michael.

final Please Cooley is open. question Chris now from today Chris, your comes from ahead line Our Stephens. go

Christopher Cooley

up taking on thanks morning follow and Good growth. wanted questions. back for to the I just

of curve international the are about mass can you. and inflection it we of if function Todd, in or had the growth high us or touch Japanese at think launch here the Japan just You particular color as give Impella we growth point you facilities? in U.S. very coming year. you Europe just the Just color in for expectations help there you were Thank the is an kind terms just and of think Wanted market us on the kind to adoption both just driving additional of there, in about in critical exiting its the with any of terms terms a year. as in like could of XXs our impressive of

Todd Trapp

Yes.

in just with mentioned patients Japan quarter another our in there. we we really the strong and headwinds prepared As revenues of some despite record had remarks, record

pretty quarter-over-quarter. a delivered million, basis, was quarter, which saw we last XX consistent currency So were constant up with XX%, we on XX% up what patients X%

in. Today, XXX we a for sites. is There wonderful been has over Chris, just technology So our get still - in us us launch into. to Japan been XXX country sites are to for it has

are we like feel still to I this And really in innings are the in there in Japan. X.X launch fiscal upcoming as you we So early year. the know, excited

excited we bring are And to Japan are again, in XX this at technology we really so strong Japan LMR and XXXX. year out year another in of and to expect sites fiscal

Christopher Cooley

Thank you.

Operator

session. Chris. back Q&A hand go Michael will you concludes Please call I Thank This today’s to Minogue. now the ahead.

Michael Minogue

Thank you, is join please a our there to today. reach If day. time directly. call taking everyone, for any the follow-up great questions, Have out

Operator

This Call. concludes joining. Fourth Quarter Abiomed’s Thank for fiscal Earnings you XXXX

your lines. disconnect You may now

Abiomed (ABMD) 28 Apr 222022 Q4 Earnings call transcript