ABMD - Earnings call transcript Q4 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Q4 2019 Abiomed Earnings Conference Call. [Operator Instructions].

As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ingrid Goldberg, Director of Investor Relations.

You may begin.

Ingrid Ward

to Quarter welcome Conference XXXX and Call. morning, Abiomed's Fiscal Fourth Earnings Good Goldberg, Relations of is Director This Ingrid Investor for Abiomed. And Chairman, President Todd Mike Minogue, Executive with and and Officer. President Trapp, I'm Officer; Vice Financial and here Chief Chief Abiomed's will for operational today's first, and Mike as format results, in then and release. Todd discuss The review be quarter which our outlined will financial fourth follows: press call today's business highlights, Minogue Trapp will were call to your that, After open we'll the questions.

the to like forward-looking risks I'd that statements expressed those Before may due call described are XX-Q you release relates that our the These a includes begin, Abiomed's let in most we to recent statement earnings our implied our statements. and or investors Officer, me undertake With update under Chairman, today presentation that, forward-looking remind is results to forward-looking with We factors. not variety differ company guarantee statements Mike and press to a Chief materially in our any involves our Executive obligation and and any forward-looking forward-looking cautions it and SEC. Minogue. of turn from factors as XX-K President uncertainties to Actual outlook. the over do not of discussion of The future. statements filed

Michael Minogue

we not March. momentarily and year and did to plan XX%. XX% given million. press comparison Thank the QX performance the course. quarter, begin you, that were in changes short Ingrid, will responsibility strong And of revenue, for and our seen performance for By action million I I generated discuss take Operating want the period, XX% XX.X%. growth a given full a growth expanded in release, tough but initiated our to disappointing prior now good or were our of anticipated morning, goal and margins everyone. of in had expectations. recognizing our have our you've results QX we soft already our the correct We $XXX I by the In to up $XXX meet

For versus the year the increased full $XXX million XXXX. year, of fiscal XX% revenue fiscal

increased margins of XX.X%. revenue long quarters medical while posting record organic 'XX, Abiomed or of profitable consecutive fastest-growing companies. device and full operating one year from we the over a XX.X%. GAAP XX% remain years has proven operating XX XX.X% Additionally, fiscal growth to track In to X.X significantly expanding execution, margins for in

also $X confident confirming fully clinical investment in short we time, We to our this nearly remain long-term and in our billion outlook. business invested thesis innovation, During and We're intact. remains distribution. research our that

I announced on I I For today's last, will X Trial publications shock; QX approvals the Pivotal regulatory cardiogenic PMDA cover and will lessons already discuss the PCI taken will on high-risk discuss impactful learned two Japanese cover new Impella and for the topics: QX; FDA our will today approval first, and I CP. for second, call, the of recent DTU STEMI actions approval

impacted QX. Protected in Impella important this providers distracted stemming QX. health sees slower FDA customer from our performance FDA to a shock, not confusion because the It -- occur response of from to is our and letter March of unintentionally from RP to business note in our prioritize significant this focus as February patient Unfortunately, with occurred So away typically first, the that result sequential believe We in care coupled X the is which utilization. on March did growth XX. our not in elective cath our safety noise reviewed PCI negatively Impella, in March. were or to ACC was reported high-risk clearly we health which believe care issues letter some had case, by was recalled was Impella being release, outlets health that the execution. patients providers this in misinterpreted Unfortunately, the and overall by FDA. press that Lab media clarified inaccurately this care the This or providers specifically FDA PCI who We RP, being

We with customers. also likely on believe our capitalized the companies confusion competitive

survey of Impella our the them customers companies and questioned reduce would resolution. if inform final they letter called until contracted FDA to using Additionally,

However, categories: or our focus miscellaneous are have internal for outcomes Impella likely in and they but the patients into yield improved had shift generally, that clinical quarter, for record internal in RP. resulted quarterly focus. may impact external There Impella in noise a fall an did X other RP revenue items

XX or shock in the RP hours failure the Study, approval. Recover To met study postapproval already for made March meeting failure differentiates in FDA right the press outcomes with the criteria more. patient's performance. from to The the heart at address ACC and Right similar right to study now FDA Recover on The clear, be exclusive presented the March led RP for have XX. Right in protocol ventricular the to FDA salvage the We had released was FDA following Impella patients changes post-approval patients the which that

With be our QX physicians for final and our to the health fiscal effective safe that the identification stresses customers postapproval importance the of FDA, and shock reinforces RP. our to issued letter care submitted the cardiogenic we by study a to Impella year approval right FDA ventricular anticipate of to of early closing end

annual last and of our employees of training, shock. with meeting over cardiologist which new we Meeting benefits Additionally, both high-risk capitalized Impella with believe Field and timing the highlight will We publications taken heart heart X XXX the of Abiomed following and all includes days the for clinical PCI on which the eliminate failure surgeons. was we the week. have on This and interventional for steps, noise community,

-- press and cardiogenic release high-risk We our two releases PCI shock. last press on also highlighted both

believe Heart for our our Recovery at heart surgeons, our reduce training business, created to X expanded to account to heart new and actions cardiologist. core MDs channel on and launch. interventional U.S. field, maintain We regionally in we the number on the we momentum including allowing RP have have office Institute and these and our with to Impella future in regions Impella X territories and deeper X.X We go new will and of expand the taken help We increasing also the focused programs medical noise. us Impella team, managers for X.X added education headquarters our our prepare distribution

will likely least require of eliminate However, a quarter the it at on execution to platform. Impella confusion all

be. we not For this rate it March, growth but we are our improvement want yet reason, it disclosing U.S. over April that today to is showed where

will We up. rise

educate work improving and We to have letter. confirmation do we final FDA publications. more pending And customers outcomes our the recent will leverage on to

hospitals reputation. back When there we and of confusion takes our on Our the and physicians and business in integrity the the is with our based relationships track. market of effort is about get on our it the to time products, products, have safety

on Moving our topic. second to

published fraction Dr. study for study the in authored Journal by in on shock found Protected Cardiology XX% prospective PCI, practice a supported XX on As survival we matches over protocols. database assurance improvement on world the high-risk Impella that and real ejection who improved II Protected and stated, have At our statistical again, in of that XX%. to prior months data than XXX,XXX since invest April, the survival physician of [ph], Babu ejection In published fraction We validate patients was over PCI believe with and recent shock April experienced by Protected the based JACC, team days studies. in cardiogenic improved pain Virginia an included X our the chest would clinical Furthermore, with Tehrani. published to mechanical ventricular to FDA revascularization. this IQ, to best Inova patients prior greater study is database AMI actively to in patient their PROTECT XX-year-old and XX% rates the from were of high-impact Recently, He high-risk shock at Eladasari cardiogenic after by publications our Study FDA PCI. increased improvements Vascular outcomes in story approval XX% FDA Dr. released showing clinical circulatory or PCI, Illinois. X,XXX Tehrani patients. on identify Dr. like evidence of left Impella quality Burzotta unconscious. protocol rose Inova, survival equal Heart complete shock at XX% the XX in over a is of that two the on X captured months. we received median in Institute XX% to best Impella new patients. of -- IQ and The use patients demonstrated of in This Interventional validate and XXX% number our became cVAD practices recently complex patients with practice from our The in best One in XX heart support XX%, highlight demonstrated, early from cVAD

times. Hospital, identified While cardiogenic three an fraction CP very an was DeMartini Cahill low, Drs. shock of received before in Impella ejection Dr. immediately was device and the stents. him CPR and inserting rushed X%, ambulance he Eladasari with placed Edward and to [ph] coronary shocked

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at utilized evaluated X indication. with to And endpoint primary an is X infarct days for approval FDA be mass this cardiac a MRI. Our of as to percent size LV will

We X also to XX patients effectiveness. will with the follow patients of complete believe at the will around per and for up successful follow-up. up randomized cost sites. patients includes It hundreds of a years XXX We failure to to study thousands We heart will enrollment, reduce this and transform heart X that to treatment clinical of includes years, out heart quality life of endpoints approximately year. X-year will study attacks cost failure, take and believe these million $XX

Committee important to XXX,XXX U.S. additional execute it heart Steering Dr. DTU outside class U.S. experts Dr. study successful the Udelson. the Dr. rigor includes honored to with Dr. As X patients announce over a with highest conclude STEMI Gregg Navin patients million Moses reach am this and Bill study field: attack will Jeff Dr. result, an Kapur, the X ensure a a following scientific I to O'Neill, esteemed the James to in is the recommendation and Stone,

can release press details issued found Additional in be this our morning.

a also by announce approval to We're becoming investment that Impella also flow with with I Impella never and for confident Turning that I of based employees have innovation. I this thank PMDA am conclusion, PCI hearts path hearts. help pleased use. is own I to Japan. in recovery received field and and for to are today appropriate have their standard improving believe with and higher pump never positive for in care to the care Japan. had interest recover and patients creating we Impella been platform. the pump for heart time the patients the want high-risk we to we excited our our on innovation, We outcomes in in home survive the In Abiomed our innovation, CP. patient alive customers improving more Based helping shock. to helping want heart outcomes shareholders becoming dedicated on and standard studies thank return new the our outcomes of of more their of cardiogenic their have improving

financials. the call Now to review turn the will Todd I over to

Todd Trapp

Thanks, good everyone. morning, Mike, and

with respectively. total. at RP the quarter CP and X,XXX consistent in at also with XXX the the The placed our in at and Reorder driven X.X sites, XX% quarter, patient the Average XXX%, X,XXX by increase in Impella placed QX. last at on impacted and the primarily grew high-risk Switzerland, growth is rate we totaled again, currency the a been of currency basis countries in currency the fiscal in performance and of we the and utilization in soft in versus Mike strong U.S. U.S, XX% in while basis, with million by has was XX% of the Japan. strength sites, In rollout million region, was up XXX for $XX revenue tough adoption X.X Germany was Impella the PCI. increase hospitals slightly Outside sites in of X.X and patient growth in units our revenue U.S., XX% combined beginning inventory Italy the CP constant Impella the above inventory Europe revenue constant our European utilization greater seeing By we QX. X.X the controlled to XX% driven $XXX site, saw U.S. continued was year. As $XXX In million, a Outside the revenue March the consistent in at Impella per have higher like end local comparison QX, at are adoption. QX, a U.S, XX% in by increased due patient which been utilization. mentioned delivered call, on an of to a France. levels other

XX in and be new of in performance the year ending sites to Our in up quarter. with delivered the sites quarter, our in million opened continues $X.X expectations. high the XX We revenue Japan with line

QX ECP. for driven the the XX% points quarter, offset to an XX.X%, was In volume, investments sheet margins XX as basis increase development gross expandable year. fourth year totaled the increase the in manufacturing Impella compared expense The $XX in than mix. and X.X, higher continue Impella XX.X% million, prior new more product forward, R&D which up the of was Moving for sales and by invest to prior we from

of launch. prior income company. for expanded quarter GAAP best continued the We basis performance are prior business drive audited points which help model. operating and growth high-risk record year. our company. leverage collection totaled and study quarter, to new for XX% was in onetime FDA XXX in the and our a our versus in practices discipline Margins year. the occurred margin of settlement using confirms due operating to These PCI will also higher to data support a operating volume, increased margin investing sustainability share the our increase The mark-to-market grew income quarter Study. for translating $X.XX million, was XX.X%, investments validate an operating both $XX 'XX. the to The QX In ongoing $XX by expense impacted effective driven performance versus in future and expansion lower shock. cardiogenic helps million our This Shockwave of tax or a $X.XX XXX% the our fourth $X.XX clinical prospective Japanese team for by strong up investment this cVAD of us study EPS X% due in SG&A commercial million, $XX per the income Net rate. reported diluted an quarter. our in Shockwave and net R&D

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

$XXX million XXXX fiscal year As in a with cash. we ended result,

In Now $XXX or due an broad-based we in year. the XXXX, revenue million saw turning delivered million, to U.S. versus outside of both increase Impella year our and the U.S. of platform. We continued fiscal to prior full of $XXX XX% the year adoption growth performance.

versus favorable in future in the percent growth. year was million and We operating $XXX up to was the Net $X.XX diluted performance, equity was to to $XXX necessary again continuing driven year. XXX investments For Shockwave compared or operating The our make strong prior support tax per $X.XX share prior increase income rate. XXX-plus year, XX% by a to while for the investment operating basis XX.X% million, our margins the year. points the income expanded

remain the and capacity. quarter in and infrastructure by we position increased manufacturing investing over our all while our $XXX million Finally, debt-free, during cash

fiscal Lastly, turning our XXXX to outlook. year

Protected existing in the and markets in approximately PCI $XX million noted and we the revenue revenue which As to for in expanded for year. to Europe The $XXX the to XX% range growth release, of the in penetration based earnings revenue XX% in $XXX guidance be on for upcoming cardiogenic year million, translates shock Japan. expect the from to the and continued U.S. is million of both

our update we to seasonality would guidance our We of will provide call. investors of to remind into was extensive fiscal next another year seasonally in typically lift the when lab increased team vacations. hospital do the to March QX. full best engagement. In on expect total earnings QX, Therefore, significant tends I like In quarter the and quarter, as issuing see headquarters activity end physician due and slowdown second summertime take annual their half year also brought approximately guidance. In after our to XX% have for represent on sequential we as our fiscal for a field also and a our our devices our we QX, would busy our is year. training revenues slow results based cath vacations to our we QX typically QX, typically year. physician cardiovascular we of

to Turning margin. operating

XX% margin our the expect the business our to XX%, XXXX of year to be in range fiscal showing of benefits We model.

groundwork like Our performance. while enhancements the Impella clinical Impella including investments and efficient for continue clinical Connect; studies us and delivering optical, DanGer in improvements and including and in new STEMI improving and Impella geographies; The platform CP Impella Shock of DTU, outcomes ability ECP gives make BTR; to Impella to platforms new new NCSI sustaining new SmartAssist will operating lay product investments the X.X, in long-term technology product leverage. products

tax consistent from excess excluding XXXX purposes, benefits. a I fiscal with impact year modeling tax normalized For XX%, rate any assume would approximately at

was and XX%. of physicians interest summary, teams native on for the time the was year we and open solid firsthand and I to line margin spend really in top for was Europe benefits physicians U.S, Abiomed the of incredible XX% quarter solid growth, the year Japan. experience look operating generation. in early April, and unloading delivered to We forward Operator, science heart Throughout It strong growth now to recovery from So please with questions. of another the Impella. operating the by as of the field north another with into and cash able XXXX fourth margin and flow line accompanied

Operator

from our And from question first Leerink. comes SVB Instructions]. [Operator Antalffy Danielle

Danielle Antalffy

relatively And explaining had know but I if lot guess, airtime it like gave uptick happened decent a sequentially. Mike, I March, looks a to in of I could, you actually what our text was RP have left to impact because base. to relatively left be on -- weren't side, the the really business any indicating so that there side user going concentrated a you

guess part? on I is just if question my was where execution was your on could you dig can guys Any And like an low helpful. give issue you impact really So this were these little be would color users? a the volume deeper on

Michael Minogue

So because partially impact are Danielle, of checks on we did your RP. as see correct an not significant

a with Now strong I RP patients and record focus not recovered quarter up on revenue, drove March. the very to RP February mentioned. Impella in month us a for have patient January, were as the and in the patients But

X.X on the point confusion a we set providing to and that also happens -- there understand those importance record, so a that an on for FDA of your focus a ball see but took drop why data been failure was hasn't was of the internal is have letter, cardiomyopathy, the Protected shock the is area that. is if something -- It we heart But more PCI. did off on it And we done. bit to of we the what protocols. put For our little indications FDA to remind our eye safety, side, along of focus the seen we that folks the in surgical patients, around our in

little that letter is press with not used -- cofounders." if do study ended and safety, postapproval after approval the not FDA out ongoing. with high device this the and However, for that the physicians, why and adjusted that RP then tweeted they still there into FDA with that selectively. thought still which is the the potential So and are anything to was that the know bit, use could issue cause it's it Impella and We would confusion, mortality, release patients evaluation FDA's ended results important "It's root are saying a impact out, a the to there be they risk-benefit, for might note exclusive still

one history, in of done wasn't March, seen So you ever at they that And what the because the where that do frustrating PCI we March, most which because record think really that expected, but slowed. PCI -- because the improvement we PCI was we've might We increase on is today patients why off. Protected for hold for Protected set we company made Protected March is it the hit look in thing growth is we the in have in and a and disclosed changes it April. a

and We wanted have in not an get where It's improvement April. prudent. to why that's seen we so then yet, overall to we're being

XX% the at is XX% for the And that why And lower lower see that is year's a so update QX. done. XX%, forecast midpoint end than formal that's probably to had of You what X% we and guidance of we'll see from would've what QX, anticipated forecast versus about the give you'll we next X% XX%.

Danielle Antalffy

April way providing helpful. the growth. commentary much That's And That's for you on by very Okay. helpful. thank the

and even and you just you isn't are gives process what Is guys? you April physicians improve. of sort confidence that beyond and fact the situation the you you in started has where it give, it's a have Just I improving, where confidence And, in if you for know, of think where the here. gives can you to color on whether reason around talking any these process don't are curious whatever can in by you on center that reeducating give reeducate a and the to are anecdotal, story to break what physicians go Whether in something this it's things center here.

Michael Minogue

confidence most to Danielle, is me that products the gives continuing our improve the outcomes. thing are

PCI. with continuing to are Our increase high-risk ejection fractions products

continuing not for less survival X to ICU. increase shock This are patients. recovery the day is in heart native products with Our

on better, new had that it as as releases company been cVAD everything So prior includes FDA to that we've focused a continue studies showing reinforce press as well to improve to XX outcomes our only studies, plus for registry X and two information we've that. gets validates to have which highlighted

always is really lift the the use been And I February, attended in platform? there what April. letter that on whole see in But so Medical utilize attended CRT in which Florida. was X we Impella DC. on a -- in was I Orleans. about again, we seeing hear that from Should only? ACC FDA Is happening to the have road field that was what the improvement about I Florida. thing NCSI final protocols and states. leverage to RP concerned what I I the -- they come bit they're expect New extensively. the questions it putting been FDA, concerning, see we also that continuing letter. to was is duplicating in Meeting Was I have it And in QX. ISHLT, happening else? want that I attended something this in place know in what's there's be the will second the concern The they're ACC and but and in Inova, and great are what's interest. They are They but at in outcomes. in

Operator

And next from question our Bruce comes from Nudell SunTrust.

Bruce Nudell

imperative there Do convincing the way won't everything where doctors? the be really clearly be elective way and reimbursement that Is level that the And package of when pertains is PCI settles cost? second development is One imperatives? my in suspect And statement perceived just that reimbursement kind evidence around to a clinical that better to adoption hindrance commercial two thought company. high-risk with a adoption key you by question dust the will I driven about rule. you have to brief to ultimate make for proposed a Mike, a questions. being

Michael Minogue

So Bruce, let I sure the answer question. me make

have questions. You X

So other on elective, one reimbursement. is the is on

that shows at angioplasty trial an elective study FDA ejection post only So knowledge, XX and, that the revascularization complete the Impella few PCI quality have get that heart our you the a have shows for a patients. fraction of that is the see function permanent on That which is we of so days gold an CABG, the improvement standard. heart population, in the so fraction, been open with they randomized improvement increases complete you utilize has patient study. When one revascularization, and controlled to and life you the surgery ejection vein they why for have in do do

surgery sternotomy process. However, point, certain a a factor at the of to turn either the don't want or down have patients for risk they because

PROTECT the we we complete II. is which average think is And the show of from new So injury. And what you Burzotta to the show XX-year-old up from that age if that and everything outcomes reduces see we was cVAD information kidney the PROTECT revascularization. studies in patient II, a that's therefore, are from in compare that's less for have our unloading continue come from II which PROTECT we patients what end a with data and best consistently Impella above, better PROTECT -- data revascularization in this outcome the the the that PCI I, well patients from complete paper as appropriate, target do to We ischemia. patient. acute for as with match cVAD -- our And our and it most in as all doing to that is signal that we more leaving do and see history

these well has that effective and don't fact don't revascularization patients. level where I for the you we complete -- evidence doing safe the that as area positive. very the see of that's So Impella think of an as a is benefit

Your second question was on reimbursement.

would PCI for what DRG because have reimbursement a we system high-risk XXX. So on have Impella of now the is under an not payment effect

hospital determining So charges the reimbursement. the end up

of have hospital over that have system of high-risk there's charges, with that goes outlier it In lower a you so if now you'll shock, last cardiogenic that tend if have are more XX months measure low, that patients XX -- and What bit the get years, higher see catches money patients of lose back, PCI, X too when is higher the do have hedges and little cycling itself, done go as you higher. reimbursement those hospitals, almost the which a we've bit the it go you be cardiogenic back there if they a cases to charge and than will to So reimbursement. for shock. little hospital following up the year, database, they payments

out system system bit reimbursement. when a or or either The there elective for a so pump, one it's is of think, Impella is of have Impella has confusion, left I for a XXX you shock set complete right. that little either However, what's up that now

have DRG he's a He He in own home now back He with the biventricular have when go at X Eladasari, he's through you case work. biventricular didn't heart. have doesn't surgeries. You He patient. his to more is have which didn't LVAD. Dr. transplant, and a of is get Impella, an

XX%. the for outlying center. specialty So for savings ejection life best patients fraction treated million hoped in with also he that had XX an and of one to the -- $X center have could've up They he's at now heart be with recovery transferred months to of over normal probably ability quality to the

So DRG, that's XXX. that's a different

placed to to top that of So is be heart the clinical most is in application patients. the again, the have around those systems lot in place. of Abiomed to has alive one all most been percentage outcomes case and lower And If demonstrate the system probably cost-effective it's of recovering not a the someone effectiveness the cost-effective, The data cost it of has keeping cost. in and CMS. shock, of improve

Operator

next question Pasquale Chris And from from Guggenheim. our comes

Christopher Pasquale

quarter here, and ones on on to I of just clarify something A quick the STEMI. wanted couple

But PCI For you revenue talked like the about in doesn't Protected based really quarter, impacted. being particularly the volume the release, were rates Mike, the breakdown it growth different. that on look

So some just clarity provide you there? could more

Michael Minogue

Sure.

Protected more we've already the saw In PCI. our the history STEMI growth. and PCI but we number the being quarter. That drop There March see month a Impella, in patients. actually a top March significantly month by What of the slow had hole is year, was down. we growth the March wasn't month mentioned, for of is part took that that March, STEMI -- things So happened necessarily impacts on still in other but of fiscal shock is and was bucket the patient it don't is March, was in frustrating patients. the March month Protected the study. last the growth And the said, in expectation the the And always only ramp. Protected the that this we at PCI in driven was don't kind treat of slow in -- the We of the our

Christopher Pasquale

Okay. off the The We sound follow reconfiguring about force. can up line sales that deal mostly with that. talked changes like they on you

the prior just So until issue, you is this really communication that guys then distribution why if a short-term seemed is very working right customer education well response? to be recently. and The system for quite

Michael Minogue

reconfigure, Well, we Chris, expanded. enhanced didn't and we added and

for several have have our that best preparing heart in times. April. the practices an distribution expanded improve That's deeper heart momentum give into we X.X go new these territory team PCI seen to more more can some have And for they you calls been do have on that's more future doing. are the new MDs we've channel so add shock. is more And protocols education We your And more and focused impact So X.X, will and we've X stay what And did with we both to of and surgeons on that around manner, the laser on do we those adding RP. we high-risk been cardiogenic training because outcomes so patients. accounts. because and focus launch. them we And region leaders, question and added we documented regions

and specifically we've any mentioned, have results As Protected still eliminating shown on of improvement, around April there. to focused remain confusion PCI have out the we but

component will letter expect thing the in the QX. we do transitioning, to is which of a we to leverage, and get Another final from get resolution big FDA,

Christopher Pasquale

follow-up? X The complete time that does is why for two it to STEMI. line, that year on X is enrollment, just so include lastly, just And Or just the enrollment? to year long? if then And

Michael Minogue

Obviously, on if the -- with indication successful have approval we we a FDA submit year the will And to it's for STEMI our to that So achieve successful. if for is the study. a endpoint. study the X X information, study, primary

life and recommendation gold if years of metric that, applied door-to-balloon that And we of be to failure, measurement will care if leverage standard have outside augment, eliminate, to heart globally. things to and we a We follow class a to is the to give which protocol and worldwide, of drive want applied do and heart around the study, around in most X STEMI There's attacks transform the trying of that cost-effectiveness. United X is world. million X around a that space, these want States, and standard that every cardiac also the the think standard and out cardiovascular the can change we'll to the quality care adhered in in hospital change not we're patients over more time, us

Operator

Denhoy question next from our from take Jefferies. Raj we'll And

Rajbir Denhoy

I also you to want to say welcome back, back. have Good Ingrid.

again. on but maybe I on sequentially maybe this off if the Mike, and why RP saw a side. more of in of the could left up incongruous offer It's letter terms just curious that the of would start in issue quarter given So would precipitated just you this? PCI you the that little that RP was bit PCI grow little was RP fall all on RP kind a I'm in yet fall could

Michael Minogue

two there's things. Raj, So

affects PCI, shock, have PCI. affects sometimes seesaw high-risk a it much If we is, there's sometimes it is had we which first we've for high-risk years, focus much focus that So too have effect on if on shock. too

my mentioned biggest things are of it I as fell remarks, other quarter and the in there hit that all in was into prepared March. the but the month happened, So

So by in seesaw doing shock, are PCI lab some RP close quarter. being were we effect that little -- the the up from cath Protected year. ended things other going the putting was bit on focus slowdown. a on There There as we and away

improvement that We -- to mentioned, Impella on they and see should of same have it's we in physician you're focused you you Scientific lab and the And it impact. doesn't an the were have does cath by at In and on PCI based continue the use do interest we see if on the did patient level gave shock. same now cath I as letter did risk, case in internal didn't slower. Edwards less on their both elective do But in a more cath think on risk-benefit. us We the numbers March or external. likely Internally, mention past, look did a professionals, to Impella the in concern, use Boston in the I you were more number. it's did again, in focus If that so in the labs, not effect itself, see you physician as stronger overall the because higher time a than physician so RP. a the RP the for the high-risk revenue. growth March January in in we us any But little see it But In lab's -- are February that and lift would we appears patient FDA compared so to had January, it revenue do saw case. to elective to patients. have an patients emergent what return the we

We drop we a little of type little saw but on of cardiomyopathy a bit also a our X.X, lift saw bit of patients. on shock

focus comes the do again, It better. to that, we've down effect. to seesaw execution. -- it's our in And really for it's got So back to

Rajbir Denhoy

That's too. of fair. Okay. ones other a couple just Maybe

the noted that in last million, you I revenue Japan, quarter. there was sites The on $X.X increase think, there. -- was So flat

It quarter, might if last have anything driven was was it curious I'm buy so And anything to that behind it last down what -- stocking there's that. be quarter?

Michael Minogue

ahead the we and little want the have QX pump. so get I think focus CP in outcomes. it's to we -- to maintain We're QX, powerful ourselves excited so a we got approved. It's to continue good of just more a

manner it working in these pilot larger more powerful, it is as access hospitals. in forward as what's to launch going will bit us of femoral patient cardiac cardiac continue so a can fast we're of able doing, remotely that is which contractility patient at to on in the But Impella VAD. we'll Japan, We of that in power. which a already we're potential look and to look VAD has the ability Impella we U.S. gives see is and and Connect we because also get left a wean capability a that to is at This at output add into hole. the this the a has SmartAssist, happen to to have native patients. controlled software the the been also Connect be -- have we of at We'll console the going opportunity to with look how never pressures something should the the or heart, year, history gives real-time What the any monitor Impella it really ventricle,

opportunity them not go So but heart. only will alive being stay to heart to back also wean give own their the home able with someone's maximum

Rajbir Denhoy

on just the one And Great. just Todd then for Great. guidance.

appreciate, the year the rates first should of cadence to maybe of over you in maybe the we commentary, last the ramping below given terms comps But that it -- really first year. the of So quarter, the issue you given XX% or being the the and the closer I that on course about year? way hit this think some then XX% to XX%, last part growth the just the of -- gave end year that range? above by or of guys quarter were And

Todd Trapp

and rates XX% XX%, XX% think first And year XX% in out Yes. played last a QX. Raj, and fiscal I over year, then the growth our 'XX, you profile were the it's if the then half great in question. remember way

the QX. in and end probably the that range towards think second ramping then up I way, from a QX in low first modeling So the standpoint, of and quarter and

Operator

comes question next from Blair. Kaczor Our William from Margaret

Malgorzata Kaczor

a on tag to little question. wanted the just I more guidance up, first bit So

You mentioned quarter hitting before it will more take normalization. one at least

at the assumes. end little QX you high both expect improvement this what we Average the kind assume guys as QX the the is year? should And So a see to guidance, bit impact? of and of does look low that end later of in

Todd Trapp

Yes.

now exiting end the would then And this year a working we just to things at Connect say some towards of the the of would of into have well we as out the as the little May on we the Right in half of launching of in of truth. would towards the that be now, of end I that say maybe some that's -- launch say and we hold we're saw in continue first year. Margaret, obviously half the the right least second the should take -- is Impella year, the frame. X.X in in half second That noise we're QX, the going the would QX So March time QX. of bit coming of some year,

that's half standpoint, a reason think second the I the end the in of why and probably ramping so of And linearity range QX low year. we from think up then the closer QX, the to

Malgorzata Kaczor

confusion. And folks referenced that then seeing speak able were you you guys that in little for quarter, to with bit of the a

Danielle to the in you that but have at bit of many to beginning, And is letter? think I able those you were asked account out to may at Or see requiring and need closing volumes For normalize were reach FDA customer out reach that able did how this those April? time to, you little this more those a again, still point?

Michael Minogue

concern had issue that until late was March. Margaret, folks is that the in we know the didn't too it

of what on both are majority is in they're if So failure patients out cardiogenic the working it of cardiogenic and get was on again out right February. RP RP focusing people, and the in or either on and also the biventricular. word side shock. in focus the shock, not subset And there we've since put who is -- getting it's That not been that's we

but where put that figured today itself, sites that growth-wise. and ability a get bunch most month their And is PCI March confidence. outcomes it contrary -- driving patients gives what for complete weekly. to It's the happened And the April and any you we're papers changes growth conveyed not hemodynamic a feel revascularization. it, relationship that's happening. the up. continue technology, We've and papers and why most population with the in the we analyzed -- what disclosing to we're innovation we're get are anyone, very The of that good is we're we hear slowed drive progress. to And not is there the out made to reinforce tracking if it you continue if level, the didn't on. into that over. or that's is and in March confident PCI concern, is support the what yet communicating FDA. we of and improving better you peers exactly seen to that's to have though business low things standard to in up March was that be or already place, And important actions Protected haven't daily And you the of the we use And making the followed that the Protected want us other very from it obviously, and from once are So the the publications are outcomes place, the want And protocol a care. that why we that's we

reiterate so of people we outcomes We all and patients, just and just we'll our again, side We so or of because based And not patients. that been may improve And helps good there that were We an the failure. seeing concerned. outcomes we're customers situation. early on. to have is encouraging look did else the irony the are right they final they at tracking process that to to was will cVAD, worried letter to letter, believe trying these stating hear going to we leverage going one's were have that postapproval the on we saw us the device product study on, that, improve. in we're they itself the on tell worried definitely surveys to continues continue they that ongoing called They that an safe from FDA with this for and hospitals. our get innovation the The bad have commercial continue were identification only that's that for and track -- effective are the was track We track we we improvement -- to to something outcomes outcomes. in based the them patients,

Malgorzata Kaczor

just for then And Good. me. more one

a you and review the structured that might maybe look Finally, how like could sales two? how for on this In is that if differently or and a making something is terms today in it guys future? support -- scene you and you maybe the support? year us clinical looks And do team in of customer training change are concerned the

Michael Minogue

changing. expanding and not reinforcing. we're and Margaret, enforcing We're So

the doing back So headquarters, here adding we're more out meetings more courses doing in we're at MDs, field. more

And We country. we whether learning axial they do we can or We're to you through before are those is patients through as around it train, sessions when what of it's is or closure, But Shockwave get to whether technology the on, the because have are the in artery more the the at artery percutaneous Impella use femoral big can get put artery the the continuing want drive can it's future. femoral we to things continue traveling we in and it, lab artery. meetings. mobile for access surgically it the axial many in things concern our with put that we're that where or the work after look to along can with and those we sponsoring and now are educate

and doing. effective. more that's we've indications make is and the really new a training been So adding physicians it lot of the do more doing But just the what of to we're new

Operator

Morgan question Our from next comes David Stanley. from Lewis

David Lewis

I guidance how for of risk-adjusted to the Just XXXX Mike, a on sense is. couple want to questions. investors and sort of just a come back give number

a think sort to occurs? those RP significantly and let's And back Or do if assuming trends of of specifically that for variety to, third quarter-like don't you to get different reasons? sort and more so, when for is PCI. emergent PCI you just sort of relates high-risk get levels of you think for it risk-adjusted, about as I'm the does So And trends XXXX? how back then should assume emergent, investors say, curious it guidance

Michael Minogue

comp. So for had anticipated we QX, tough David, In a question. thanks the

we the very growth had we XX% it had The a by year, So we so XX%. did driven for it PCI. in we X%, high-risk March, we is reason XX% in growth growth slow And we had prior missed so number. because missed

if we've And XX of Now to what next year, is XX%, XX our it have what to midpoint XX%. at XX% done forward adjusted into X% moved down been is then the we've we approval we've which normal range. look to would

So things we're We've being X%. transparent about what we've done. moved down

We are seeing an improvement in April.

the at reaffirm to to guidance the we out new everything the the will and the the progress give We outlined end the training, either And of perception. get working letter RP a also hopefully letter. we're another, position or we're FDA with closing and this improve doing guidance QX, get

what is and working the are things per we're just QX in And question. adjustment risk So that the those would it say, on. I QX. is, your It taking into moving happened

David Lewis

some maybe should that cadence other Todd. about simply here to the XXXX? stabilization thinking R&D you are XXXX, XXXX? see cost incremental regular think perspective first R&D that for and to slightly it as expansion? about for just -- line on had the reinvestments these basis? beyond specified, sort talked there After back you profitability reinvestments Or second how we of then do margin an the the Or think tied And from helpful. now about or R&D profitability get expense XXXX, Mike you growth? sales for steady of to we Very Besides or what the sort of trend go-forward factors And do higher of in about Is talking now quarter? about slower XXXX, incremental issues market you're are you these Okay. just that extend

Todd Trapp

off Yes. by David. year. question, do expand And this Good margins start we saying I'll expect to

a of walk an year from few standpoint, fiscal -- But them just Okay? in investment 'XX. me let through this you

expanding really Mike in deeper the to We're we in surgical also XXX somewhere the more the at the looking in the as cardiologists, team. new and especially we're which to in us mentioned, add go to distribution sales heads X organization And the the new year, educational sites brought adding Mike to interventional marketing regions, As allows area. range, are assist X MDs and we efforts. mentioned, with this

year. a XXX have last material SmartAssist, headcount a heads We We're carryover out rolling our gross OpEx and cost and with made little software increased to headcount also and With upgrade pressure that our year, of the margin able year. but in optical that on additions to really company from see we'll last our so significant drive margin, we AICs. on to -- a with this that's we bit leverage higher we're expansion hardware CP cost said,

are We in around little as we SG&A more Japan STEMI more bit clinical cVAD. and also up making have a cost And business. scale the we DTU, investments DanGer

And it's business expect say at year, I'd for margin see operating of but a expansion. on a a So bit at to XX% this of range, little we'll a be we investment midpoint basis. the do GAAP-reporting heavier margin again,

Operator

O'Brien question And our Piper from from Matthew comes next Jaffray.

Matthew O'Brien

down. that little new -- metrics? about scratching may metrics? be that Or go a on could we one top the as at go the heads I how are well. of morning all this Is end just you back, line the that kind guess that? could people I it would mean, up, is Welcome that think QX. it do And of guidance at thing commentary bit provide Ingrid, their this

Michael Minogue

have we We to have. we think be prudent PCI not in So transparent to candid. it's that and expected the March Matt, high-risk did

a know It's off we're QX for what people year. thought So we've happen letting in we X% next adjusted. adjustment of what would

some do, we fiscal And between XX% of disclosing QX, why our that so what reaffirm down miss want we we from because either likely April, growth in year are end we seeing we of adjust moved a the on which people but the to XX% are X% don't understand had of we will you had guidance or we normally of progress. logic anticipated today, and QX -- growth. X% get the we'll it at of We number feel

Matthew O'Brien

with outlook Protected business? the of kind then short, forever, shock And been XX%, the for happened think talking came do several guidance the for can't going a is just No, more for There's but that is Fair both question I and been Okay. Mike. is, shock the well. up on two shock them forward? enough, the about this doing And sense of the you how in I'll but about Abiomed second plus did norm us XX% that some here been you've give And on that comfort Can level quarter? PCI and the together. then you've years. for just what year you we lot again, how me, and top for specifically should new for line and being think focus

Michael Minogue

technology PCI. clear, be numbers a We shock. not which some April to March, don't I issue is population the a happened what is So overall. the lot around also board, what's FDA and in did pumps where got around Impella. balloon a specific that better there's we've information. new on includes think in never normal more patients we the have and we that them also wanted is lot inotropes get progress exclusive are that happening used still that. The of is energy Protected got And shock There is approvals. we're But in even seeing across over March We've know growing. I think of

have quality a the we get belief communities to help TAVR. for customers just outcomes. the to And our referrals continue to products, but on and our PCI requires we us in we high-risk also have from to focused have So to need continue in to High-risk lot improve to stay them PCI. both and of shock similar safety ensure of that,

to ensuring we But the studies formal patient and customers and support a listening It's focus. the regulatory, need the through time. the it provide at they get through them work that's to that So also our we're good down outcomes.

Operator

like And I showing lines. further our back no phone Mike for Minogue over am any to conference turn now closing I'd from to questions the remarks.

Michael Minogue

Thanks.

interest. investors So the call the to thank your I on for all want

will we'll and any be Have And other next them take week components and around working time. happy hard one-on-one, today we're your clarify specific Thanks great call. there day. to are questions if any move forward. to We the be to questions, of for or a

Operator

This and wonderful gentlemen, participating does and conclude the may Ladies have program, you for conference. a today's Everyone, in you thank day. all disconnect.

Abiomed (ABMD) 2 May 192019 Q4 Earnings call transcript