ABMD - Earnings call transcript Q1 2023

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Operator

Good day, and thank you for standing by. Welcome to the Abiomed FY '23 Q1 Earnings Call. [Operator Instructions] I will now turn the conference over to Nicole Nath, Head of Investor Relations. Please go ahead.

Nicole Nath

Good morning, and welcome to Abiomed's First Quarter Fiscal 2023 Earnings Conference Call. and Head Abiomed's Relations, Executive Chairman, Todd Vice Nath, with I'm Officer; Nicole Trapp, Minogue, Officer. Mike President President is of and Investor here and This Financial Chief and Chief format today's will as be The follows. for call

business release. first Todd our will to the After which that, will results, highlights, in outlined your review operational call quarter we Mike and and questions. First, this financial were discuss then will morning's press open

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

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

Mike Minogue

XX% heart with be U.S., record records hospital and a million revenue shortages. resilient currency most the achieved X.X has quarter of COVID Abiomed everyone. XX% basis supply and recently, fiscal ongoing to good first quarters has Japan. patient company labor in with addresses on proven Europe Abiomed surgical emergency and year populations quarterly of hospital the year-over-year in and technology and variants, X reported delivered XX/X morning, Abiomed last media constant up epidemic multiple Nicole, contrast despite in record suite. X the Thanks, support shortages, a disease of in because in lab $XXX across the and of headwinds our chain revenue, up the constraints XXXX, cath growing In

quarter, million the a patients achieving focused we in and Japan. U.S. utilization XX.X% clinical of Europe second supported had in the highest development Within and the on number record research while strengthening investing operating innovation in $XX remain evidence, We and and patient margins.

$X We X,XXX IP the patents Our quarter ended with pending. with maintained patents and debt. just cash continues to and portfolio X,XXX grow X over billion in

program, Additionally, new $XXX component this share repurchase upon $XXX morning, capital of million our prior announced plan. a deployment anticipated our closure a million strategy the of we of completion

a of performance breakthrough levels clinical technology, financial record and dynamic Our our Abiomed patients us in playbook which enables disciplined our is advanced of operational this research support environment. execution continued strong X.X of result to innovate and

today's driven Impella highlight of heart by call, like the strength I'd recovery continued with products, our For X.X. to surgical

for pump population by XX% shock. validate failure that guidelines the associated trials. pivotal multiple cover procedures. suffering U.S., we've surgical with the finally, our with will will And benefits surgical the revenue Impella with cardiogenic we driven In in heart publications data X.X. increase classroom progress of from surgery. review heart provides patient grew Impella-supported we made clinical chronic SmartAssist pursuit Starting with year-over-year, revolutionary Second, of PCI a XX% This advantages in the unique

XX% ultimately improved which required this patients XX% these home These across implantable future. investors particularly continue LVAD outcomes Japan, overwhelmingly game-changing our positive to similar the June recovery in are of heart outcomes Japan, success native watch technology new for of the find patient Impella to product on and website. previously our the Dr. investor in their returning X.X we and early because U.S. patients We've duration with surgeons failure, Jane rollout Hospital, all innovation with stage surgery presented survival of D'Alessandro survival our in I meaningful David Dr. Wilcox As and call with Mass anticipate webcast of stages General this launch. controlled with and for a that transplant. support from heart all in to surgical Memorial a our has rate to during witnessed or heart Northwestern indications have encourage and Investor hearts. In and would feedback. rates faced protocols durable, this with of setting irreversible expansion the We the respectively, sites

physician is XX% only physician not but and such practices improve pre-PCI Impella without at heart in showing best XX% shock. EF, of getting Impella years. patients. last demonstrated approximately data. greater published contemporary implantation relative and function associated best overall one an LV recent -- remained or which with fraction, an designed AMI New RESTORE Impella These and stents. implantation Impella life best patients the shock the symptoms Impella [indiscernible]. most improvement to XX% one left a PROTECT that and rates to of the Heart has XX% RESTORE rush survival X,XXX and population improves recovery. and definitive well for rate follow-up, an the in Impella to as in abstract enable mortality cost-effective clinical ventricular the be show the field survival practices pre-PCI prospective III of of CPR a lead cardiogenic ejection statistically meta-analysis high-risk quality this The the The physician placing a evaluating to XX-day month independent makes cath participants before most of Class multicenter proof practices been multiple lab. with it's reduction life before experts or a technology greater as improves heart the ejection recovery. PROTECT later Heart overall complete will studies high-risk totaling CMS left Denmark meeting. in In for lower reduction XX by recognized placing At has studies Class of Impella-supported quality and in versus Cardiovascular Association in hospital, medicine. and was as Germany, combined International Japan. IV field highest circulatory support the published stents, the considerable study multiple and published cardiogenic Canadian United than IV and than PCI mortality their the III the from York Cardiology now clinical recovery Turning a can of PCI decade at in study practice, FDA therapies X, cardiogenic and recently baseline Class AMI developed Impella as shock the It States, post-PCI ventricular May, places presented PCI failure angina study II studies with large last Journal over the EF Italy, XX% XX and heart the in their XX% the patients is Cardiology publication significant papers, demonstrate III had in physician summarized native Class more heart sometimes demonstrate survival insurance. improvement, a studies after Society symptoms. of patient up Impella Medicare fraction private PROTECT Multiple revascularization are AMI in This

enrolled highlight towards through -- This PROTECT quarter lab. to QX, clinical improvement both fraction. measure trials. rolled one I'd for and In most of Impella we IV evidence in PROTECT the the is patient Lastly, progress revascularization, had patient trial with STEMI comprehensive and high-risk compare We for of like an our DTU. high-risk will Researchers IV a IV. XX pivotal the Impella-supported quality done studies life cath advancing of multiple enrollment versus record landmark PROTECT Starting PCI without in benefits PCI complete ejection will ever support. patients.

do today. we to announce the with represents initiated patients patients with to Impella-based treat all-cause an shock a the FDA XX prior attack standard excited in randomized days DTU of XX XXX,XXX we that trial shock, versus not for pivotal also population we expand patient is million mortality an a patients IDE IV. X which could trial, QX. If For trial FDA without this into strategy worldwide received heart I'm U.S. PCI that STEMI, our of strategy. care cardiogenic successful, approval cardiogenic STEMI indications non-Impella-based in patients and in This in treatment July, controlled RECOVER comparing enrolled treatment

or will generate from to been in EPIC, and which to patient has earnings Our a details protocol teams logistical believe patients in with The our help have posted study consent informed the what FDA ethical slides. worked enroll due concerns. we on closely focused to a population historically are enroll difficult exception

level and studies If prior FDA achieving of for current I goal are portfolio medical guidelines. of with Class built practices the the guidelines, a medtech Class and decade in STEMI. we a off approvals, I with be Our best PCI, high-risk dedicated highest exclusive the cardiogenic we'll only shock company of believe RCTs IP guidelines successful, and

takes and healthy the emergency North patient drove a himself week Motivated Center. I'd him with pride in room, history Medical multiple Forsyth was a North Brazilian state fraction February collapsed. Ethan a shocked Medical to and Center living XX at lifestyle. Medical pain is in XX%. arm a to got Carolina. Ethan of trooper he when like each catheterization his to experiencing Ethan Ethan Before instructor. a CPR cardiogenic Carolina. to gym, Jiu-Jitsu Ethan XXXX, in and lab disease, old, in reduced in arrival of ejection Kernersville shock XX, share concluding, Bradshaw, On times exercises chest Ethan story. several after the heart He times Upon the from by years before family is a transferring performed personnel Winston-Salem, numbness

customers of Ethan's and where stents. days improvement X implanted Ethan support, home meet Danvers function his Ryan. baby of headquarters Summit. Ethan conclusion, X/X employees In heart enrollment the at heart story in we months was pursuing developing our May, recovery to Annual boy, event, part as our inspiring Ethan guidelines. and function and and for returned heart In and field Dr. in hospital, relentlessly the Trapp, heart studies I and after normal, clinical commitment and PCI with and was on weeks Impella they smaller, In X welcomed his I the the toward our would we smarter, clinical care commercial native we visiting to as will heart July, to of his with our shareholders utilizing QX, weaned returned his more are X to a Samuel outcomes a After our continued building their made removed advancing key accelerating their year. Ethan's in progress Turner of of of working SmartAssist Patient and our call and excellence wife, in over devices, to I turn heart. fiscal remain he and returned focused share CFO. recognize our for line Class are with like now employees goals Todd and showed Makela Makela, CP developing standard their new dramatic heart duty. about After recovery Today, Impella and strength. Abiomed, the SmartAssist. placing connected its before through support. So better thank the of continue

Todd Trapp

these everyone. and $XXX year-over-year and Thanks, growth year, rates. XX% prior in labor revenue across XX% foreign record deliver and to the on basis Europe tough reported versus and hospital Mike, We good strong In despite media up from our morning, results supply contrast Abiomed Japan. currency U.S., QX, million, exchange delivered and constraints constant with record playbook we comparisons a shortages, of executed headwinds X.X

strengthen, increased the revenue utilization on revenue challenging year-over-year despite $XXX rates resulted million quarter, and X% During the our to saw which Starting a to favorable prior X% unfavorable impact in to impact call of and compared environment earnings exchange mix. the due first X-point more growth with the versus a on the dollar quarter time year. we in revenue continue last a U.S. U.S. patient at to sales Total

year. to quarter last on cardiogenic prior in the perform labor XX% a X% year impact the was from AMI in revenue media the both in down growth hospital investors, in top to well supply. grew we with prior growth XX% As shock challenging XX% and PCI of and contrast comps of due shortages year. the High-risk reminder XX% to of continues growth QX

versus the XXX suites. the Our now another with strong SmartAssist. prior in X.X revenue driven X,XXX CP sites demand XX quarter by Impella XX% in fiscal the X,XXX for of The with end potential At is QX, of sites, up surgical U.S. had products Impella in our is surgical the growth, with quarter hospitals X.X U.S. continued sites Impella the out

slide of RP in sites. is our XXX summarized in base installed are Details Impella quarterly the our product Lastly, deck.

and reorder the reported of line favorable in quarter. XX% in levels Average U.S., combined million, Our per XX% year CP increased in X.X up constant year. revenue in currency Impella for the units XX% Outside growth $XX the revenue constant performance the prior the was X.X inventory and in on currency. XXX%, a utilization prior quarter U.S. due year with versus year-over-year totaled XX% at patient and prior prior top the basis on the and to site, with we quarter hospitals sales mix. European inventory saw last flat with

regions Austria We like continue Italy, the Belgium, East. Middle countries to in see and strong patient and growth

X% R&D PROTECT by constant for we in in in Gross by million, and IV new QX year-over-year. million margin year. new to support growth with patient quarter in total currency, our in quarter. control Japan Our lower by consideration by This a to site the reduction by to an compared increased year, $XX last primarily expense XX% the prior sites. year-over-year the openings hemodynamic up our goal of driven we X prior site variance out period and site in the education. bringing 'XX. for to liability. trials margin of the The commercial randomized sites, a training STEMI revenue in increase and associated in of due in the first the future of openings. was clinical our to business $XX translated in same driven non-GAAP therapy XX% quarter and volume patient increase DTU pursue XX% headcount global to innovation, continued of as and sales driven XX.X% for expense prior was utilization site potential to driven to the quarter a In increase Revenue the year, our awareness QX record, of standard production income was versus in openings our investment opened net delivered QX is contingent commercial of the quarter, our and million, operating $XX growth. the and openings X ongoing totaled manufacturing first Non-GAAP XXX care translated research compares excellence investments $X.XX, Non-GAAP XXX patient team, investment XX% versus both The was for enrollment, million XX% offset 'XX. share support. per quarter an additions operating of the becoming This earnings campaign which XX% totaled of income SG&A $XX versus of of million. XX.X% partially $XXX and X quarter, the

over generated tax of billion in adjustment marketable $X Our higher we million $XX and was flow securities. just an to quarter, and year-over-year operating performance by cash with ended the value investments interest carrying lower of driven our a effective income, June In strategic cash the rate. of

strengthening initiatives intellectual organic property priority top cash growth supporting for our and remains advantage. Our

guidance, mind of fiscal terms keep year In experiences our that in seasonality.

usually summertime slow cath QX in all cardiovascular a Our devices due slowdown a quarter the for lab. is to

current to We in $X $X revenue $XXX on expect a This our due revenue XX% decline to sequential of million, a QX QX at range constant from million currency the rates. of record headwinds to translates a to of XX% primarily to FX be performance modest basis. million

In and addition, from impacted be we anticipate labor extended this summer to workforce, by ongoing with physicians, coupled our quarter hospital shortages. vacation nurses

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

to begin FX this release, morning's of COVID to of half growth. for impact noted second to we expect a full an As that guidance rates, into our constant do shortages and in are earnings assume future be move current rates we material year. as we state growth year. to to This XX% business the that reported fiscal maintaining moderate more year hospital on the to have XX% now XX% revenue XX% the the currency and not continues guidance moves ways endemic labor At

also our margin despite playbook a strong the we first delivered full maintaining X.X focused In XX% remain Abiomed disciplined operating through Operator, guidance summary, to year open We recovery. field of of on on our are execution We goals XX%. as challenging and year to environment. quarter of the for questions. build now we please commercial line the executing 'XX clinical our continue new fiscal innovation, evidence heart excellence

Operator

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

Brandon Vazquez

Brandon is on for This Margaret.

was Just device lot peers would able looking to hold really of of kind results the XXXX towards really have and year. that fiscal A slower than guide. recovery the seeing encouraging, starting they great are this a medical

And any out for despite much you allowing curious than is if seems have to industry slightly guys like that So confidence guide recovery and you kind sticking that? guide what guys in giving comments the you on you that seeing? a hold that's of of slower what's

Mike Minogue

Mike. is for the this question. Thanks Brandon,

a an to put bit opportunity bad. of little good for forecast Our things and happen,

every our think we And as bit you double-digit definitely new get we're we does, from clinical we and more year, little exciting I and as going by with contrast a a that quarter be an business, confident well. will with us also upside. more what's in are elective media But closer have PCI high-risk always can this is surprised shortage. is launches, because we for the bit a that data. to patients are, further for also of have emergency cath surgical and more But the back, QX, It lab our it and growth high-risk emergency were products as people little impacted fiscal of an see PCI, suite. come revenue but business. the year and business goes most And to

So fiscal by surgeons be a is the year, the launch sheath. of X.X. will end smaller available this single It's product French our To the excited a LP the for to for right compatible hole heart RPIJ reduce access. that's to will a by We're failure. new everyone, remind going sheath be with

we're excited I have patients to the issue going We're helpful overall PCI very the be year. launch of We lab. product to and market. know in positive very a going people, and a shock think cath Breethe is big for access that treated a and the in high-risk U.S. it's to end have for at

revenue reimbursement And in category enroll this protocol. to again, BTR generating So more is briefcase the year. ambulation. right smallest confident And to start a administrative the during we're And legal we'll we're the as going of one and but we're as basically continue now quarter, in second forward. enhancements taking pivotal by have ECP patient of probably do devices able the of and durability. in course, for on contracts be the the very for the and best go the on blood compatibility IRBs to with of end did to our because a EFS, we're the we're through hopefully, of to opportunity make B We progress the this the It's we size that. going

clinical year So and also in the the a not of we're very because we innovation very going coming. feel data, like but the place confident new into good in just QX

Brandon Vazquez

of coming and mean it keep we Is harder. there? we X.X, Where little existing should side what's growth products of it's segment coming what's growth they just deeper is surgery from Is little comps a getting both. and are And or expect going that about X and what those accounts, looking larger numbers momentum But up a underlying those driving the into talk from coming Can in product the can year? X -- a what -- to through trend new from just bit it the put you as accounts? bit from? the maybe getting continue rest I that business the despite great in how

Mike Minogue

Great. Thanks.

not acutely there out decompensating chronic population heart there's but shock. shock or So a failure heart shock, AMI that's failure

and frequent Impella product. X.X the are flyers become the is these So go-to the then has happened what's

ability you inotropes minimally So have they -- through invasively X-year-olds diets take their surgeon to they're gives their and not or these coming off the the this decompensating. they're the And in put didn't something in, axillary.

can it the to get to get patients and can hour, device acute back what's giving an unloading while up and perfusion and sensors, they renal has these around. than less the walk protecting The So kidneys. recovery baseline patients or heart,

the it's and a the to heart now pump. great It pumps invasive All blood is really weanable heart, because apex core minimally right product product. the have you aorta. have a then So a the heart bypass revolutionary prior you to required heart out of a and you sternotomy, been out the then of

or So ideal that patients older it's not recovery. want for patients

to all recover deeper to The encourage live to your Dr. and of bay, I really cases. show question Wilcock, the Northwestern Dr. General they and really that it these they kidneys. team protect it's run because of patients, go it's some more Jane David patients watch in and Mass where from both question, would heart engineering their try in periods coming, longer. centers. For time. device and D'Alessandro And does has investors is chronic it transformed volume the failure extensive runs heart more In the

that. everyone to the hope opportunity I has So see

Operator

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

Marie Thibault

for I of if your quantify where that media been of fully with wanted you centers? sort question is Do it's with could contrast And it here to that for most quick us, the you a wonder size I on us? start now? feel impact. resolved it shortage

Mike Minogue

the question. Thanks, Marie, for

during hospitals trend to to up smaller COVID. -- even high-risk relative growth of we positive That continuing. also base As PCI. able about of COVID emergency we're work because been to positive had pick how had quarter, patients of and the customer we has more And talked each we've that's a during first maintain evolution our the the the year

bit access was to the didn't our potentially a contrast. give that's high-risk have little saw it, impacted the what that numbers what of access. Todd the can However, quarter And the centers the smaller bigger on whereas centers PCI. had we in

the was comment was we Todd, want U.S. on monitor to majority It spotty. we're to do you going us. that behind that And situation. of is it So the believe But all certainly, the the over numbers? continue to

Todd Trapp

Yes.

Marie, or XXX So few, mentioned, it's around minus our but Mike would plus somewhere think And which we it of by a XXX to X our in high-risk ability, our about impacted the occurred the mostly patients patient quarter, have overall in growth points. as best obviously PCI business.

And so again, we that's of if additional points worth X on what PCI. you think an about growth about high-risk it's reported, patients, XXX

So best that's mentioned, ability, Mike that's we And -- contrast at smaller in from the as came how up to our the mostly QX. as it of media hospitals. -- the what impact was with

Marie Thibault

I to here, Wow, your operating little spend. talk great that's follow-up, And bit my wanted really detail. then a about

You've adding control R&D. count. in I investing think very your manufacturing And had some head nice sales on and that -- I you're heard manufacturing

What you're new little those a about hear are capacity, sales some going and control? you manufacturing areas be more how where focused? of achieve that R&D to reps wanted expanding bit to I So capacity

Todd Trapp

Yes.

sales for think in heads. the I terms was quarter, in Marie, XX, that So of somewhere XX heads it

just We're the hospitals to, continue at say, where standpoint. of given surgical the on would more account a from are we We X,XXX. invest I penetration team, XXX out

of some where, would investment really that's the say, went on I commercial team. So our

up franchises. more hospitals ground. the I because well second we We smaller the in during as a you more, at we regards say, feet that on a to gross looking on of grew Again, go half know, we for potentially quarter. little few And say, ramping With that margin, are boded had workers I think would are a the again, it's would bit COVID faster hourly XX% in adding volume the as regions, more we year. few us to about just clip our still, to the more a

Operator

comes Your Pito question of line Deutsche Chickering from next Bank. the with

Pito Chickering

perspective, major of about a a the Impella some from any the during ECP numbers sort talk get trials there, revisions updated we then to if hardware product possible? quarter? And enrollment for minute, Can software

Mike Minogue

Sure, Peter. Thanks question. Mike. This for is the

protocol. out the And we protocol the On we've approved. ECP, feasibility pivotal March, the closed early had in

all across and enroll the all Board work we're this is at more our for process and a norm, IRB We're that at at and to data X that collecting months. the going that So to administrative a the the in X-month those be can We're lot it patients. best, utilize continuing submission. hospitals data. don't complicated legal it's follow The

that, have we're IRBs a working that activity. we through as we approved, So has site approved X the single but don't have site

pivotal. We few to to are making that do -- product taking the make the continue that and on throughout make we'll we'll a enhancements opportunity the

will So as benefit That's the this that's also working of again, the designation -- that breakthrough something part has, with status the happen. That's of doing a early product. on benefit feasibility. FDA that

Pito Chickering

Okay. growth Japan Great. And sequentially. then Europe and show very strong year-over-year and accelerated actually

within of assume some for markets what you rest the your guidance and those more the do there details curious is on Just year?

Mike Minogue

protocol or are the for hospital. in we We pump, get base heart with market focus which know to focus left heart. with run those unloading shrinks and with their geography keep longer-term they our the Japan And the their -- to and going geometry X.X, stem is we a be rest ventricular recovery to we'll tend Japan providing on know partnering the we cells, institutions left over that we of X.X, do a now we myocardial immediately coordinating the engineering a where is in patients extended recovery. ventricle. allow gets The native have Yes. year. the heart By The Impella surgeons around the ideal device

know also perfusion. get we We renal

[indiscernible] patients. I'll be going the be and And about there excited research. And there in So out, the be we're running. we're these October, again, to in shows The community for traveling. and society this doing there back continued up getting now advanced physician is very are And protocols we'll October. chronic

Japan, and forward. Germany, progress and U.S. all we're research the in and we're is the moving over in so And we're

Operator

next Your Nephron question the Research. line comes from of Pasquale Chris with

Chris Pasquale

randomized getting trials which an messy are the great at trial see ended ensure you've of nice exception studies and on I informed progress clean see. and prior making the you Mike, in value a trial Impella consent, been the shock, some with But of attempts done to this other quarter. in with to and from this that on a design other up have should approved with IV to well-balanced there it's enrollment. help got do Congrats things population? data. RECOVER That's some look clinical end challenging you that up with cardiogenic that

Mike Minogue

Chris. Sure,

harder they hemodynamics pump inotropic flow. a a makes U.S. mentioned, but is all in balloon as you And only which for clinical XXXX, back the pump benefit of zero also improve arrhythmias, in on cardiogenic mortality studies Abiomed X logistical not the thought they we're people when patients by when the In working balloon based we only ethical was space. pump XXXX, was and balloon this [bail] enroll balloon has a which you heart shock balloon published So to in attempted did have challenges it study, And able pump. out. did not in is of it you the the that even the cause II New the In and They can CPR member because don't in the dangerous. that patient RECOVER decision a that physicians detrimental where they to and England able the they've patient. showed showed also Europe, exception. work study That been these the because work, do have or have Journal that consent was SHOCK to pump hemodynamics did getting more XX% to protocol not X they the somebody make to outcomes, these generated go to try almost was place family which an the CULPRIT was have patients And find had Medicine, don't the consent that a II drugs, the

now IMPRESS. So tried in We we've tried We times to tried Europe. [indiscernible]. multiple

the it All felt of studies started randomized. randomization. those None were further got was concept difficult. they too unethical physicians Because into the of the was of study, as the or actually consent studies those with

say of they we just -- are. of started authors -- studies not They're being not fact ended are studies would publications them. -- despite not they they So there that they're some up the certain funded the they've randomized

with they to to on the them EPIC us -- the what's X called work and exception FDA, are So are informed They in EPIC for an X.X ruling years, consent. on cardiogenic we've They authority we shock body the that They as step for patients now years. can utilize now the authority. working can been went with as that consider get far channel. these

However, We IRBs to we do these physicians the And the not we it. all randomize approve also it. will still physicians patients. to need recognize need local

as is in leaders which the However, ECMO use treat oxygenation. in lot new they this centers, patients they're shock, them of this developed space, a practice the ones want the leaders the as of also protocol, And space, what's best these pursue to published pass that and that first they've have the treat some the study. they not published way just these

have ECMO to oxidases and FDA ever events other that and have body, do arm, option ECMO. ECMO, problem first for not the you So of measure the will be hemodynamic issues. done the can life-saving in and components will has adverse to cardiogenic with actually a it's but the shock actually where ideal cause study they'll the it the anyone's ECMO other it It

protocol the like So right Impella now and that decade. determine for where duplicated before for studies And of in execute. on heart RECOVER published and identifying around has pre-PCI. looking PCI, randomize, shock the shock practice And have hemodynamics over arm. been to in failure to be a for We putting their best these feel is monitoring formula ability we've This Impella other been really we customer success. will their base the will ability a be of doing that protocol. Oxygenation really, other with this will all the IV

to excited So IV. we're RECOVER do

Chris Pasquale

If I already with remember injury issues correctly, enrolled one at some evidence patients of lot of of also the brain that was got IMPRESS who admission. had a

a anything chance to that time the make getting they're that Is sure we're at late. and them too getting So still issue have there with deal these support? try to patients and

Mike Minogue

Sure.

XX only list. of PCI, Impella The of the those patients X So X before the out patients, patients, there got of were the majority XX got Impella. X

that randomized within than So randomizing. survival not the stopped IMPRESS. ideal got in the had we is many a not of randomized PCI is arrest they had were were XX% these and not which And pump XX half sequential. in. Unfortunately, cardiac done XX and the have after they this were an cardiac arrest, of them not pump. a even And more patients in patients balloon

society, study. that rule arrest in will and cardiac protocol. guy from IMPRESS And XX% know, can cardiologist to E patients out and shock Stage protocol, be not the you class that can rate looking severe and in A Chris, in Then did you of interventional IMPRESS XX IV RECOVER the mortality E. we're range So from there's you X% the a that was range we an is arrest. mortality really a have cardiac They has E. in original of at and The through mortality as have only a shock

data the of Impella but balloon and get are And is analysis really these databases notice go includes they the the with you'll they balloon arm. ECMO, Impella that these the don't they a come or -- by to patients go that the ago, not either And is now in that's that. into pulling out that arms. write arm ignored. because will in balloon it metric. And it from So biased is are they is disclose when [bailed] arm Impella In the also databases they're on people pump in one pump that patients [indiscernible] people the sick ECMO pump out, that challenges X get years

put have all to that, and want one we data to encourage their another but we are protocols, and in to world's own data. folks the treat So our to randomize. that publish come studies the our papers out The experts them join writing our databases,

Operator

line Sandler. Your next Piper Matt of from comes with O'Brien question the

Matt O’Brien

starters, for product. mean with a finer Just sequentially Mike, that I meaningful acceleration to put on a X.X, that point was

centers put as as far other systems on been as coming far as using the talked are about some of based just far these but bit a new utilization, some the centers outcomes? adapting on they are are you trends? on, centers and now that And and point faster have little of year You've just even finer seeing you're a seeing as what can their centers what a are X.X maybe as for then that

Mike Minogue

that do And I that encourage question. for we have better, but full now the examples or past is kidneys done other recovery the past LVADs the a answer Thanks better detail considered of the do high kidney their X-week Yes. and and or with you during either And whereas the to bad to see the guess to go show a interesting And they cardiomyopathy It flow might often flow. we wean survival is I it's and out, see weight, being back. is transplant. Impella are what's volume seeing not the see VADs VAD. rates, has than really use everyone listed to that they come maintained. good add high with X- all have flow of because rates we recover. lots ability just the best or forward to way of get them the patient what's as still did also for we now the the patients think heart, believe the watch does from that in inotropes webcast it's for you're X.X, the is transplant. patients that And back, pointed patients I some see into why don't I'd get heart the better the advance, most also the gratifying experts it come they because growing. kidneys X.X kidneys is the also routinely now to

kidney transplant. and So just a transplant, now these they heart getting patients are don't require a

know to breakthrough the LVAD that anything research forward flow they the X.X, do, those for Impella the with today great it's And for a again, have invasive but especially not biggest admissions the tool heart product. of it's data pump. that's and the clearly the world And like come heart population covered there's clinical weanable So there's it's hospitals. don't minimally the a more one really emergency into space, a to that in -- surgeons, what

Matt O’Brien

ECP. on finer it. another put Got then wanted to point And just

study I going think the EFS you've pivotal as well. the got with

patients I think collectively those include in because the pivotal. you EFS can

up total. you're So XX to patients

Just And the make making there's to no product, product. to some tweaks you're delay want that's the sure then in right.

You're lines to just were I same still expecting expecting sure as that, clear. you want just before? that's of make time Is kind the -- there

Mike Minogue

the Yes. questions Thanks for to ECP. clarify

out after we approved. the patients. March, In pivotal closed So XX the got IDE protocol EFS study

using on pivotal collecting now protocol. So the data we're ECP

contracting, some we QX. still While data the the collecting up that the we're are all we're pivotal for site IRB legal in under And did and getting but cases making protocol. activity centers data, and enhancements, we is X

be Impella our So we're a we'll it's show II Remember, and it's is X.X have to to And single-arm what absolutely study III. and [indiscernible] patients. we PROTECT utilizing PROTECT that. the the as up trying data that from PCI XXX as safe CP

Operator

comes the Your next of Mike Wolfe Polark Research. from line with question

Mike Polark

little a the they significant I not maybe enhancements follow more you that. for Mike, how on means, shed or being made? are are ECP can The just product? will And enhancements, what on up light that what

Mike Minogue

enhancements, we've their products make and on Well, don't we're and we all ago. enhancements year doing, improvements disclose those. making been patient Mike, over reasons we're we for constant the things first and very competitive But since -- a the

One is of being study flexibility. you the benefits gives an that that of in early feasibility

other as we and we'll to everything we make a study -- to you as We're around are enhancements through The do. designation that but confident and more go always patents we'll enhancements continue continue lined the of benefit the out that and breakthrough file can you enhancements in having we're go. is -- these going make

Mike Polark

just my on follow-up U.S., XXX numbers for in of kind can June in I centers the If the center activations X.X and ask quarter. round

the And XXX in but on Or -- of years I think X.X. you at is the you eventually you're there's centers commercialize U.S. do X.X with roll next more level? have network over chance will kind stop X.X that than center We X.X? were there's to in a good the continue past you've in this you the of as couple and centers, X.X guess, in the on the data surgical suites X,XXX provided forward

Todd Trapp

that is this I'll Todd. -- I'll Mike, just Yes, answer one.

X.X the be X.X. opened is we of Every sites, going we new you and quarters, at looked many just haven't up now X.X went last sites. site to up with terms if the In several open really back

site you back last between continue, if and And looked XX at been that just I went and quarters, the next so averaging somewhere think should XX cadence. quarters, for in the And X.X. that several X openings think, or we've X I

us with many more So to X,XXX X.X, I surgical suites going going And U.S. in be opening you're X.X. forward don't see going it's again, with sites to more the think have just with we hospitals

long a just growth X.X. of have us We with the runway ahead of

Operator

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

Jayson Bedford

unfortunately I for the Just Todd, Todd a the Or into the dynamic, Mike. patients XQ? patients for but and appreciate on contrast couple these then XQ, you one procedures just lost? are these spill do detail there, missed think in

Todd Trapp

great a It's Jayson. question,

I think ourselves. something measure to we're trying it's

essential them think back into be "essential", of a unfortunately, at to back in treated. come aren't they the think some been that seen have need might probably mean, not I lab, over to there's point of patients staged elective, cath pandemic time. a and patients similar obviously these coming the but portion the that of we will they're what I those Again, course we've portion and

QX. The back to we portion there's the expect all, timing come I is we come see that expect tough to So call, system it's but these some patients I'd would system. say, do the to of a in of to back in, into it say sometime to

Jayson Bedford

of Okay. enrolled patients trial? XQ, From in in in a And patients the the they be XXX ECP, included for couple then, will Mike, just on the pivotal needed follow-ups. the protocol X

Mike Minogue

XXX Remember, to up patients. it's Yes.

access PROTECT CP. that information. is the data and match II can all closure X.X on safe-eval III we're we PROTECT and being is but primarily so and comparing on XX-day know compared And Impella the And at also numbers what to both collect we're and we looking MACE,

have looking is we're that's put indication. what we well into ECP process, DTU get STEMI can on. working through And IV we as And we're so as study, PCI, the which our the And ECP intent. already that so to the PROTECT high-risk the

Jayson Bedford

enroll pivotal? to pivotal protocol when And do the the in patient first expect you the [indiscernible] Okay. but the pivotal

Mike Minogue

Yes.

now center So collect that in the and the we all pivotal. be is, we will activity, pivotal approval site the IRB collecting will are that data the protocol has difference the but the

procedure early And of so feasibility. we're this -- the having that's and the doing benefit

that are now be we'll data we So collecting using.

Jayson Bedford

Okay. and the the still to just I'm trying the pivotal and pivotal maybe -- protocol between difference reconcile

Mike Minogue

-- feasibility protocol So now were approval in We're we're study. early the the data pivotal didn't difference existing in the pivotal that is study. -- is that centers utilizing that collect the that the be the at difference the collecting in was early in feasibility we will the

process that As XX making we IRB approval some get first it pivotal we're then now, in activity, that get will everything waiting site the on transition protocol. to through doing will out on because went and will the and for we're we're the data centers site But collecting XX continue. be the study. that, is while and the up IRB we're PMA the the just the with be to product. And can the enhancements the the We utilized

Operator

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

Calvin Chu

This on Cecilia. is Calvin for

Just me. X ones quick really for

around curious it staffing I'm business, Has -- in on headwind pressures has just -- the just outlook of procedure the intensified? improved? just incorporated And impact staffing meaningful of of been on volumes? a particularly how Has your your staffing PCI First, side shortages to sort PCI what's reiterate impact?

Mike Minogue

PCI for the priority. to try need The to the across step go. where is issues versus or are done what than PCI we've CPU patients to board in emergency they emergency. staffing high-risk minimize the That's med the It go essential more Calvin, high-risk is patients And ICU impacts then tech. also our So down.

lab. double-digit people. this that's what the benefit that one get so treated, And they and other was and suite our priority, apparent similar the to the surgical patients in the growth, emergency are cath and is But quarter shown both drove

Calvin Chu

one on then second And Okay. IPPS. the is

up was following final be IPPS continue slightly as think again, guys, So well. outcome good proposed to a pretty you rates positive for to a I rule stable and rule

XX%, DRG. periods associated and high is a for number it's I think DRG with to, historical X, think other think I I specifically ECPELLA growth which compared was also up

this trend sustainable curious, see we just read-through there? Is going any can that forward? So a perhaps

Mike Minogue

Yes.

can because we're the a great now we sickest growing. Impella support, software experts biventricular treatment with needs lets on ECPELLA, every DRG-X, that's XX% And oxygenation place its has that appropriate or and and the is by so CMS DRG-X, be have set that's integrates ECMO physician system right system the new Impella patients now board that in that reimbursement quarter, and patient our the the patients for wean. XX% to allowed hemodynamic so and that's I think treated for to they of that's of up know a around that's

And that patients acquire getting We the hours, high-risk ICU, to then, X of cardiogenic in going to have shock support to in that and last is that's the those are course, for X we and that's hub just -- DRG XXX. have is that to X PCI DRG spoke. And we're are X and days XXX. even

the get distribution So that nearly now the experts it there our can U.S. and And phone out in most the cloud the the again, group can -- hospitals our as largest ability all get with support. the team tracking we're in can bedside or patients the -- most be

XXX. in that explant patient the then patient Impella large that So with receive assist hospital have that DRG that the a already incredible ICU that in. to and to hospitals we them we're this to for able the manage smaller also patients with and in the gives now support network that bill that's want patient transferring and center Impella monitor device. reimbursement And And can

appreciate the is really as one above. and has those CMS incorporate of studies heart But pays as Medicare and we our cost-effective occur. that Impella So FDA recovery experts XX-year-old the for about thoughtful well all allowing and that really of again, physician to patients very technologies most societies the been

So it's the can to taken thrive in community. us heart we're appreciative here, but get now because recovery many years

Operator

call turn session. I concludes This the will over the question and to answer Minogue. Mike

Mike Minogue

you, everyone, for if today. reach you follow-up your great a out. Have please day. have time thank Well, And questions,

Operator

call. conference today's concludes This

now your may lines. You disconnect

Abiomed (ABMD) 4 Aug 222023 Q1 Earnings call transcript