AORT - Earnings call 4 2023

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

Operator

Greetings, and welcome to the Artivion Fourth Quarter and Year End 2023 Financial Conference Call. [Operator Instructions] I will now turn the call over to Laine Morgan from the Gilmartin Group. Thank you.

You may begin.

Dorothy Morgan

Good afternoon and thank you for joining the call today.

Artivion's CFO. are from and Mackin, today Berry, Lance me management Pat team CEO; Joining

to begin, statements Reform like of the or to within forward-looking the we assumptions of results made time subject differ with actual as The Private Litigation of statements Litigation Before involve and I'd the expectations future.These of uncertainties, Act may the number on risks, the statements. are to following Reform company's uncertainties look Securities forward-looking intentions, predictions safe meaning include comply materially this statements beliefs, risks call Act of statements hopes, harbor forward XXXX. to from management a and cause forward-looking that statements estimates requirements of the made XXXX. or that Securities to Private forward-looking Comments make in these the are and

may contained SEC Additional in earlier uncertainties and forward-looking that was that information today. company's the these in issued is certain concerning filings press time-to-time release impact statements the risks and from

CEO, today's Mackin. find turn You on details it highlighted website.Now, Relations on to the the presentation Investor over Artivion with also a section I'll brief of can call Artivion Pat

James Mackin

Officer want Thanks, Vice President and and today new Laine, Executive Wright recently as XXXX. in Executive good Chief until most at served November Operations to Medical by afternoon, Stryker Vice Financial Lance Chief Berry, start I Officer; and with call President welcoming the our everybody. of by our Officer. acquisition and Lance Financial

the Lee many company value I'd broad join we medtech today. leadership expertise we of time. thrilled this Artivion thank to of service for confident are have will make to doubt profitable dedicated his phase exciting enter as in Lance like also are the during proven team contributions Artivion no Artivion.His to We add next outstanding his significant our help and I'm years growth. Ashley

an revenue just outstanding of to XXXX year full report fourth the achieved currency year I'm for Now the pleased to XX% year we for quarter that year growth our XXXX and over and compared full constant on XXXX. of Artivion, was XXXX results; full to company total

programs exceeding to EBITDA and further topline free year-over-year, as footprint.Our advancing making target, to strides XX% QX of throughout currency us a enabling we revenue in cash strong achievements expanding growth million delivered adjusted we growth constant our year-over-year, our positive XX% nearly culminated XXXX clinical achieved deliver flow global of addition in particularly In revenue our while $XX.X revenue. growth in resulting in

revenue constant X% followed compared at business, was stent each in performance the approvals processing driven and footprint our a grafts at Latin increased new On-X especially fourth regulatory of We've in growth, expansion improved basis. growth which geographies, our XX%, quarter through to when on BioGlue by currency Our by the commercial at tissue XX% XXXX, of and from America Asia-Pacific. benefited also all XX%, across

constant new our SynerGraft We strong I by volume a bleeding market, XX% sustain the Tissue continued in were momentum the the clearly of strong adjusted to graft pulmonary share products, a Tissue strong supply on our product support fourth should Our our quarter progress on take stent last topline valve. of expansion into of stent each the are the America, fourth of we the share the maintained continue in our constant into primarily currency continue an expect fourth year, remain fourth of improved footprint to currency as approvals to last revenue the business processing mentioned performance presented in results continue procedure.We perspective, in Latin new the Asia-Pacific and performance of in fourth U.S. showed have in million market AMDS to aortic is X.X revenue the anticipate XXXX. regulatory INR From the increased both can on constant year. currency a last $XX.X is commercial in the the aortic compared to and in compared the quarter, view. year that which grew XXXX, which improved demand of On-X growth performance.Our we our revenues in of XX% fourth And of to revenues XXXX fourth the XX% due the initiatives reduction post-approval quarter the continued quarter double-digit lastly, X% as recently supply globally for a and compared our growth and constant graft a in currency proprietary data, beyond increase XX% compared results which Ross We year by On-X and our to our basis compared increased earlier, driven major believe market revenues led last and through fourth year.We quarter and to primarily EBITDA strong non-GAAP XX% heart strong outside on basis basis to driven driven of delivered be in by Through increase markets. valve significantly making to expect last gains expanding best valve mechanical our an pricing and year to quarter quarter only also X.X. quarter valve

expect these leverage we coming into our further growth over be portfolio to years regions. continue the We regions these to drivers as product industry-leading important

In performance, Annual data the interim full STS with the our financial the science San trial clinical late-breaking clinical to second, strong the and continue trial. from TRIOMPHE at presentations in AMDS leadership PERSEVERE Antonio.First, NEXUS in the from field the Meeting to we show set advance data two clinical our addition programs aortic and

revolutionary with of a completed control approval, occurrence experienced mortality endpoint are end mortality.As clinical primary the in In with adverse the IDE of Malperfusion. cohort, XX for the of significant full of PMA this patients any detected event. endpoint without data to consists reference DANEs A in had enrollment trial equal to for MAEs, its XX% context, Results study XX% met XX patients the greater adverse trial been there from than demonstrating DANE MAE DANE Type dissection. for or in adverse up First, truly XX% that result. of historical up or report is follow-up. patients the three there the DANE, statistically also mortality, XX-day I'm in of reminder, an have shown associated we of The events than of increased reduction reintervention to data called primary statistically The with the from has a DANE X reduction event, reduction years endpoints, the patients a one STS the a patients patients presented demonstrated PERSEVERE, reduction adverse MAE. at with XX.X% to occurs nor the following equal to patients relates of safety in no based of combined November repair year, major well a the efficacy as days events tears, after major set and tears on greater point had equal were and of trial all-cause and FDA only IDE IV was to which target data which is risk than hemiarch showed standard of of a one significant it greater all-cause goal or DARTS representing AMDS as this trial to treated last to trial XX% procedure.As all for compared in pleased which our who acute AMDS. Critically, care reported to no major XX% the any hemiarch at recently

in XX-patient participants detected been have we these stent we the our trial endpoint the products remains strokes, graft failure processes as which system.As new prints, demonstrated a accelerate option included enrolled two from trial, where acquire summary, option If on data treated markets U.S. currently for in growth with PMA we or again, approval the patients In our in to a these NEXUS excited data and anticipate, for market in any interim the XX paraplegia of study no very in primary opportunity. addressable of X% assuming expect TRIOMPHE Endospan, XXXX. the Arch the approval significantly XX about Second, proceed Aortic are we that graft it of should NEXUS Endospan, patients renal IDE today, for time, assuming we and XXXX.At NEXUS NEXUS exercise these track XXXX are there in approved. AMDS PMA mortality, two increase stent would exercise products will

calls.With in call testing entire to forward look on R&D I year. turn replace on Lastly, aortic start our I'll we that, this proprietary on to currently the Frozen final stages, used now progress our is additional later arch Elephant trial in Trunk future expect to third-generation -- Lance. the the called to ARCEVO our and our LSA pipeline, IDE U.S. providing updates the over the

Lance Berry

Thanks, and good everyone. afternoon, Pat,

these Before our regarding including to earlier non-GAAP you reconciliation results, to press I information our remind published begin, to please results. to for refer like GAAP results today I'd our a release of

million from free of in to noted. in discussed changes fourth and quarter.Importantly, QX cash currency percentage achievement XXXX otherwise basis, XXXX, XXXX, increased in flow flow XXXX. the XX% for quarter fourth in Revenues fourth of year-over-year the after to the cash XXXX, were unless of and were year $XX full million critical quarter flow generating revenue million all adjusted for rates free will growth $X.X cash generated Non-GAAP of positive XX% milestone $XX.X Additionally, Artivion. of the be million the we for a representing up EBITDA constant quarter of free $X.X third be approximately will million $XX.X on compared a we

increased margin increased flow of labor. increased increased compared in grew basis, cash and the increased and X% driven From inflationary in line, million grew on to XX% administrative fourth to fourth quarter fourth quarter in the product XXXX. fourth in compared quarter and revenues XXXX. price expenses the XXXX.This stent expenses compared As Other XX%, million On regional by in XXXX. importantly, administrative expenses QX general, XX%, in were we in materials translation BioGlue include marketing GAAP in quarter R&D in XX% improved and the XX% of to the Tissue General, mix, of Latin of $XX.X will that million $XX.X the gains XX% for to $X.X On-X was were income currency line quarter America of to XX%. increases be in expect million revenues expenses Non-GAAP approximately increase compared to offset per impact XXXX. perspective, million a revenues and XXXX. Gross revenues Asia-Pacific fourth of XX%, million EMEA $X.XX graft and we diluted million.On all and fourth XXXX. in and a net continue million $X.X processing were both quarter by in free Non-GAAP to $XX.X positive bottom loss foreign quarter was reported or revenues partially $X.X while North product marketing of America $X.XX the million net the and fourth quarter the fully compared fourth per quarter expense of share net million the $X $XX.X or quarter. income of fourth fourth XXXX. $X.X approximately share $X.X the interest

credit both impact to our It million had of now $XXX FX momentum, $XXX contemplate revenues building XXXX; million.At agreement, XX, shortly. enabling of in in the as current debt. important December for I rates, impact our our And speak outlook of to As will to reported million to for XXXX, comprehensive not this note that on in cash range which achieve does adjusted million is on us $XX.X on approximately $XXX management, general to year-over-year and revenue EBITDA for continue recently expect we and closed we the representing the is initial be $XX the growth constant XX% and to With XX% our XXX over basis. expense be points a expect XXXX, adjusted this XX%, of million million to margin X% full to ranges. as expansion $XX to growth year at continued topline the currency revenue range of our of midpoint range Therefore, revenue basis we negligible. to the represents and of in growth XXXX reported expected EBITDA

at expect margins to gross XXXX. similar We remain to levels

evidenced proactively force leverage infrastructure.Additionally, would to significant rate. range, to to for global relatively and at remain We our is expect our adjusted our by of sales guidance to of the Xx significant EBITDA drive targeted XXXX, year-over-year XXXX been million midpoint note XXXX growth the drive G&A below our is a Investor There to which commitment percentage growth at in topline sales. our our as is growth $XX flat expense midpoint Day. as has no continue to expected that R&D XX% expectation like March that originally change we our I from range for

this investments We of may of non-dilutive the levels is at drawn facilities as top a maintaining maturity $XX pleased sales. expense maturities. our that level have an adjusted but strong credit credit are facility include in Driving the bonds initial while in July investment priority, million R&D of a driving growth at an senior not the and $XXX underlying to financing any improvement EBITDA we the our to percentage balance for and approach. comprehensive we to facilities our this their are to outlook for our future.We business, loan sheet of need revolving $XXX that The make time growth strength term closed secured our of term today our capital XXXX. very structure, $XXX feel in longer In regard million million a loan, delayed interest-only term refinance X-year recently a to convertible unfunded prior additional with million validate be draw

term as do notes sheet on close $XXX convertible and contain use existing our to flexibility credit continue with of financial initial retire facilities revolving maturity the credit senior $XX balance million strong us best debt. million our related agreement, convertible secured facility gives were expenses. cash evaluate options from some any and not credit at the no to to performance loan Overall, reminder, financial near-term the this a debt drawn As address with our the overhang with our along coupled covenants.The pay transaction we

SEC guidance. of [indiscernible] the free housekeeping our of our considering to shelf prudent relates cash We the intend are the status.As not statement of to we corporate following also We matter file good registration a a Form on formal XX-K. this filing strictly with view X flow, reestablishment and it as giving

covers be confident positive from facility, while of expansion free us flow new million our in than The at being incremental capital to $X.X of midpoint in million positive. the the ability are the room to growth the business interest we provides $XX still for However, which working cash free adjusted of additional cash support EBITDA XXXX. credit more flow the

with Finally, I modeling. want to your few on assist a comments make to you quarterly cadence

will of that, back meetings In particularly full and comments. vacation XXXX to lowest these annual cash-intensive the is the are -- to European most to turn third in XXXX. season.QX flow activities, payment the to still about for to excited Despite closing we due typically the positive of is normal items, for As XXXX be of first business year industry heavier be such to in QX I it Pat cash cash free seasonality, prospects conferences, relates our and revenue in quarter negative expectations because quarter. are flow for free quarter the his due expect our our bonuses to our growth the beyond.With with of which as summary, quarter, impact flow the cash thrilled are we and the the sales performance of call and due

James Mackin

Thanks, Lance.

in we're As the finished XX% pleased to a adjusted aortic XXXX and on heard XX% from and revenue fourth you company. EBITDA with continue growth world-class to performance with We our Lance, extremely growth mission quarter. our strong deliver build

clinical We long-term pipeline, growth. our positioning meaningfully us continue expand markets advance for to and our well

showing as valve, [ driven care X-year in number XXXX literature recent by recently growth we to market our reduction a to in gains business, price XX% that in is by driven we And profitable and continued with On-X for an three, SynerGraft in share Stent fourth, driven following: XXXX reduction our the XX% capture structure, America us new More Europe of beyond. data Graft specifically, growth adverse We aortic look the no continued Ross to Number at patients to control. this PERSEVERE working, of growth ability year continued valve, giving of well and will the in of data one, presented and major reduction growth standard in two, growth continued to forward financing mortality approvals. compared and in improve supply. our events XX-day the XX% our our major our the proprietary growth our non-dilutive by increases, continuing XXX Latin by efforts growth ] from from built through pulmonary procedure bleeding.Number overhang.Our in our strategy deliver as momentum also our executed channel and investments STS capital driven a a runway a Asia-Pacific presented be sustained showing regulatory

conclusion, in our we of near ever and confident are our So than in business. prospects more long-term

to with open I all thank our for Finally, the an want exceptional for year.So around globe delivering that, the operator, line of please employees questions.

Operator

comes with Wise [Operator Rick Instructions] Our question from of first the Stifel. line

John McAulay

Hey Pat. for AMDS. is Hey start on Rick This today. I just to with off Lance. want John

And readout some STS maybe should of how the us 'XX? meaningful You thinking in doctors, today? clinically the is I opportunity wanted performing Europe just this U.S. strong how to And how you be ahead remind really as had data in just recently. technology eyes we the look positive at we to about is about

James Mackin

one. that take I'll Yeah,

years blood was the Type trial XX% is a reduction reduction the So a an in where had to not And that's of I've patients kidneys exciting XX the significant seen mortality, more the kind disease the So Malperfusion, Medevac just actually required benefit middle in the largest give brain, events has So background, device statistically clearly, and a done patients which to right? night. in that showed of is cardiac -- one in in ever very for field device. the never patients, dissection infarctions. of which extreme were done the state lot this to adverse major showed And typically with with legs.This XX% kidney of of people a the are A technology. in kind patients of I'll seen a means acute you death, alive. myocardial It right? technologies. been acute Type I've flowing a patient and a series this dissection this we've XX FDA of trial also very strokes in that patients they associated A have devices in in is dialysis breakthrough

those XX% major So reduction in adverse we events. saw four a

this a truly very -- is we're think technology, I it's So life-saving excited. really a and

we're about Our in go investigators opportunity excited have new you of We'll in very are have a adoption this.It's market the a market. surgical is been There's innovation. obviously, million graft protected through is steps which in competitor. all U.S. about a competitor we'll have through done This $XXX -- go hemiarch, But to the that's a The highly the all to been the XX technology. alone is years. product. a for patented other There's no no

this like it we're patients. about and a feel a long time, to for out getting market own we super is very that will So Artivion excited

John McAulay

the And on just I follow EBITDA understand to business. That's then guidance. helpful. reinvesting on in up the logic adjusted the

fourth on Tissue noticed And business exactly organic focus are of areas high digits. grafts teens. Just on particular were an side, revenue the single stents quarter, I then was Preservation in then reinvesting innovating? high curious, that And the the like basis one, more in what you

into maybe or we rates should somewhere think that middle? as similar 'XX, find two the expect from in just those we So about growth

James Mackin

Yeah.

me let second Lance the one. take Let first take one. the I'll

seen the just an you the we're in company, significant trial So we've in right? which building a getting replace we're FDA we're by generation years. then investment you've Lance AMDS said heard literally ready U.S. got year start as and as called as all of it the in we increase aorta far of that U.S. -- that as And as It's starting some as get said along, So technologies this investments, developing next clinical several We've as P&L a the the entire to his our We're topline ARCEVO. about. percentage market, R&D literally to the But been to in we've in well. comments, really arch device trial a is aortic for behind growing starting one identified it. and our Europe. do our will breakthrough as percentage can not because here technology this revenue hold PERSEVERE, FDA.We

our being So financially topline we're being line, to growing and pragmatic about XX%, invest still range, being disciplined, in bottom very of XX% able the innovation. midpoint

and this bottom that a think I is we deliver line, topline, can So shareholders something flow because like should pipeline. cash

So take can you question. second Lance, maybe that

Lance Berry

Sure.

about growth was tissue growth those XXXX. question into processing flow graft the and So stent and how

So think I normal level growth call stent just of I grafts; would QX, that on fluctuation the kind on of first rates. quarterly

Again, stent processing, about may quarter-to-quarter.On mid-teens. full For year, of the for in we you the think going how second from SynerGraft we that's And grafts see quarter the year really into price tissue grew benefiting are business in the -- our we increase that full technology. some variation XXXX. took on XXXX

we helped So the to improved see that from quarter and bit fourth little benefiting a of began well supply as we're that. that, the in

So little revenues the beginning in be we tissue may of a to the see XXXX. higher processing

year, in kind about kind that a the of the talked For we grower as full think past. double-digit about we've recent of more

Operator

question Our Needham. line with the Mike of from next Matson comes

Michael Matson

Yeah.

credit facility. just start the the new So financing, guess with I I'll

with just you of you transaction that be at in you'll of kind to year can kind where following of the tell So leverage EBITDA? regard ended terms and last us year ratio where your

Lance Berry

Yeah.

$XX.X million. really So the of million about net did of EBITDA this post of know thinking XXXX. off top that head, And about don't $XXX I my [ we of it in you're right end ] debt at transaction,

the I guess, I quick? do mean, on math that So real

Michael Matson

X roughly, point something yeah.

Lance Berry

-- the by of the it kind XXXX. flow, range of X.X is some of where we'll we is now, end midpoint Yes, X we'll get that right and and think approaching X.X cash it the get to

and new EBITDA credit there. that are So definition in agreement. some out we above favorable actually covenants have they're but point that would a level, in the of good progress I really the there debt, well

actual is even an that on credit agreement, less what the than is as-adjusted it basis. ratio leverage per net So

Michael Matson

do I obviously, Okay. then just require that without And you FDA think a AMDS, or on just Do expect helps. data the looked really good. panel? you have approve for they'll panel That the to mean, a

James Mackin

haven't detail I mean, going going is of we right? gotten haven't what to this I gotten on I'm results. do. a yet. to the We super -- level obviously, think data speaks population to FDA But not for Mike, I with opine sick that is the itself, phenomenal mean

So we're soon obviously to get with the going work possibly out can. to we as as technology them

panel So or not, I can't really comment.

Michael Matson

Okay. the And this or our goes, that then mean, as that is so XXXX as far more ARCEVO -- than just be could earlier would timing, point be I really that? at it

James Mackin

Yeah, that's 'XX. think right, probably late I about

hopefully, to So and the a get some lot trial. we of get year approved a patients the at enrolled. again, start-up we there's IV bureaucracy can But of expect this

the and like think development and We this involved just a these centers of it. in super-excited in lot top centers were the technology, I So that's of of we feel the right. they're this have the kind -- about

to enrollment well, So is there cycle. follow-up to got FDA through our pretty I then expect but you've and PMA go go an a one-year

-- of time probably for that. kind some 'XX -- So good a there's is timing it's late

Operator

Our next of Kalia with Suraj the comes line question from Oppenheimer.

Suraj Kalia

me hear you can all Lance, right? and Pat

James Mackin

Yeah, we you fine. hear

Suraj Kalia

few a quarter. one have I COVID, mean, through start let consistently consistently you every the beat of Pat, numbers me out has congratulations. probably with even that guys

Pat, the asked. again. define again, How U.S. you congrats low market? size hanging the had number know can once questions just I the AMDS, do audience Pat, for So fruit? up on you been a of

James Mackin

Yeah.

there's So of ways of basically, a look the up slice if to -- different you kind market. at number

is about up with a So of be ASP to that The we number million. came going $XXX $XX,XXX. device on

done Type about acute the A dissections there's X,XXX in So U.S.

the is and market back research napkin can X,XXX $XX,XXX of math. see heart feet. a physicians in two with really multiply earlier number Again, a the that that's million. -- the and not together a the is to you these kind trying trial.This substantial $XXX talk device, I done We've physicians, an are seen question, and failure you I've cases, said trials get know XX some a where to of So of more you from get as technology. very somebody of the walk you're you

in significant life-saving in.It's of The You're talking that technology. in is mortality. about XX% the extremely sick standard so technology. a an that are control X.X%, mortality were XX at We group emergency, patients And was XX% and a Medevac reduction these days. are is at this care

force. we're we've a very used sales excited, aortic is So in BioGlue got and dissections.

On-X in team repair. sells the sales valve Our aortic

Our [indiscernible] device used in is arch. replacing the

are this we kind dissections significant aortic the an XX So first is of and acute in company, A Type in years. innovation

mean it really I to change I'm super is of lots. lot going and So think this about excited a

Suraj Kalia

how Fair enough. Pat, move? queue. Lance, QX, a in I'll you, quarter. just you. impact should we for net questions in and And throw hop Lance, think for about back bunch of your the way ASP the sequential Pat, for

needs I of you If behind give portfolio label, know else just in is be what of to at terms process done? is us. stage, the kind in do more generally, mitral next the think and this steps just the any In point us Pat not, FDA On-X or Also terms optimized? On-X this mitral, at of -- status. But time,

James Mackin

I'll I'm while work take talking. I'll Lance the I'll number take piece, let and first the -- the last Sure. on

talked as So business as if the recognizing endpoint, INR off-label body is don't matter statistical XX% up that of -- in the a as with last promoting are nothing the and We're largest the mechanical the the is ever the XXXX, in we January. close it the into fact of than QX mitral you from PMA was evidence actually valve.We people is data. far can the of want value PROACT lower just it, had our statistics significance really Mitral, level presentation a at ended about the matter -- The missed get around So but I There's end because that's right? grew And STS of the recent choice. will recognize physician's details we that. people of we guess withdrawing -- which it's fact of trial. the of the to I not Mitral

ones. So grab couple maybe over of other Lance, to the a can you

Lance Berry

Yeah.

So on number in can exact which tough ASP, an products, you with company, countries. total think kind different the be on without different mix of giving I different

the I is QX significant our this talked business obviously took in from tissue highlight meaningfully to price year. benefited of things about. a think which We increase price, we've

And increases, running that have pricing we still that, we On-X, And out well. that annualize of and the portion benefit had particular, then kind so price will that than a QX. call year Other QX, the have the normal we from in for taking favorable business but I in increases. would in some of type we'll price will we're not as outside of anything on

James Mackin

an our them. other U.S. FDA feel the is period. and acquisitions -- one things X-year trial more agreement ARCEVO in us we AMDS, I with I We X-, NEXUS of with kind question Endospan option portfolio. the the shape. Suraj, had, stacked quickly excellent up the mean and then is portfolio then trial, acquire And an three was see to question, from did one said from of you distribution with on we behind you the earlier to And got device mentioned Yeah. the FDA over like the as we've can fairly going

going other on significant anything.We're -- SynerGraft get acquire very point we I totes of valves up potentially 'XX of pricing, mean this volume, to at some year the of valves, pulmonary number double price where make asthma processing, increases every procedure. would said them was we a some in really in the significant and had is price that So for sell improvements set do to kind those end of because our itself a we we only we're did of the 'XX The quarter, the the on XXXX. a as of from significant And portfolio and times, need year SynerGraft, our one standpoint. of single availability well to we've of yield growth of the I've the I not first the because on Ross

grow significantly. confident in tissue very that feel we again, So to continuing business pretty

Operator

with question of question. proceed Please Cohen Our with the Thalmann. Jeffrey next comes line Ladenburg your from

Jeffrey Cohen

the That's Is in for company. tissue on or we my opening all-time that Suraj right question, 'XX? that tissue Thanks, for how about for sustainable business an the segue should think into is up which first high XX% forms.

James Mackin

SynerGraft Jeff, I benefit we significant on get which the XXXX, the had will obviously first as and in commented quarter. Well, I so think some on Lance mentioned, some just increases in still pricing,

almost doubled comes with kind that pulmonary like Ross rapid processing literally we've this also we're some we've yield of the procedure, that seen out I that the think said, because off improvements because, and our growth selling growth will significant of our top -- of of surgeons, availability year, we in continue, by working During of we valves, everyone area.So the line. that our

is So the answer question yes, going it's to your to continue.

Jeffrey Cohen

rate, geographies I at there? Wonderful. And XX% geography that LatAm tie by a secondly in for geographies? lines know guess, I that on geographies? and you could comment you the product little how or of out but does specific out some any into bit us, call Asia specific And

James Mackin

XX%. just size. Yeah. in Latin grew They're Obviously, are growing Every region Asia-Pacific double America smaller, and digits.

seeing we're our regions. again, double-digits So, four all across of

Jeffrey Cohen

you And are clinicians the and a about then just us, far death it. little gain prevention of looking period? tear as structure? could a the or in that at And hospitals a got bit lastly Okay, as it's as associated for cost talk

James Mackin

Jeff. caught I that, if sure not I'm

Jeffrey Cohen

far As -- and and being measurement DANE it's viewed as by how yes? its

James Mackin

it's I was it's a got Actually, I what a certainly Yeah. people specific not this didn't DANE know understand. many mean, until -- again, area. topic into we probably will

standard right? it analogy, about way. hemiarch, the -- think have to I pipe. tear a plumbing So this they in where You tried actually make In current the

to got little fix of piece that You pipe.

a DARTS But to all the PERSEVERE again, So problem, a you lead the connect you've the pipe, of it don't old got time, fully in in times, the so a ends what put is higher XX% bad DANE. they It's which functioning which leak real doing years where at AMDS. and piece a patients connection, kind and a the Three see to zero. it you the depends it. requires pipe.That's a do it make trial having piece you XX% new you -- in XX leak, to it of XX patient piece XX% the get in, mortality. trial, and of now and you're hemiarch. a the out, happen. they can a reoperation the on connection the can with to up old We with Like, take of Up

the FDA mortality endpoint. And as running economics So efficacy primary mean, significant But the added us DANE that. we're thing. this on re-ops I a for and in interested extremely patients, health obviously these is a has actually been and had

Jeffrey Cohen

Got it.

fantastic questions Okay. super year. the and That's on readout Again, thanks the helpful. for

Operator

line Takkinen the next proceed question. of Frank Lake Capital. comes question Street with with from Our your Please

Nelson Cox

and the I'll Cox on Hey, us as maybe there. the throughout there thinking refresh there, of on Can seen but sales walk through maybe there Nelson the internationally you nice thinking you've Obviously, this year? size Frank. is growth your team force just just current well. some the for start about size maybe

James Mackin

Latin where in America. now feel probably We've XX in person had is I like may Latin talked kind nobody Yes. we When Asia in have of company, America. and needs about Asia, twosies Latin as about of kind and there. onesie Latin We a a here it Asia, We're probably started in We XX to one be. people America America.

mean, Asia Kong, feet got obviously an product those Hong approval. street. add Taiwan, some to example, run of the of the like Thailand, regions, see for we in add product the capitalist, direct is we'll then we're regulatory get in the had continue approvals had we venture approved a we're on and direct there. we've significant we we'll size right? treat somewhat the adding to as and and add we just approvals it we'll Australia. approved, We've that -- We've but approved, is approvals get as we which I If a We've incremental big in people products had opportunity approvals really NPV market sense there. people. in we're make cost there.So just Then

is our on a self-funding requirements see back. EBITDA and process depending standpoint. go from So titrate the helps that But self-fulfilling that that through. we Hopefully that we pull an can gated approval it's that We area -- we can coming you. Asia really what commitments and

Nelson Cox

that what obviously take you're the curious talk seeing Maybe about Obviously share, a more you're there, no, what the you to just maybe their but other there there. switch from On-X. can a just from quarter does. bit out lack Yes, you competitive hearing over I'll maybe landscape? Can Then to clearly just strong continue competitors investments thereof. or

James Mackin

Yes.

major bleeding.So by very basically three which did mentioned and market research are kind call lot is over and some about centers, patient over in -- this year, I we the the of next talk valves. we the XXX saying. way, unique study, accounts, that research, requirement. the we we On-X it And a that We performs XX%. I've saw to to cardiac which I a post-approval take an on customers presented trial what the like We and share I'll in it's competitive kind guess want INR, that research, so We double typical share. in see talked the FDA XXX it shows went career. rigorous -- just as They reduction competitive what years surgeons, October XXX to low your the community in last less have or than accounts, in November, a my valve share So our XX% of continue performed did FDA done of trial XX as

a is new it about going after customers data going excited and very are be we're excited set. our this meaningful We're So it. about to and

Operator

at for no management Thank to floor I'd comments. over turn further like back you. There closing time. to questions this are the

James Mackin

I Yes. in Obviously, about my be events. readout adverse with XX% reduction We wrap time I'll in had here. PERSEVERE mean AMDS on in quick excited XX% mortality, up. this great XXXX. everybody's appreciate We're we super major reduction

America. price continue the here this also to use third-generation the there get Asia and care see to We're share our in Europe, drive and as efforts we of bleeding, in patients Latin our I but multiple countries in later be U.S., after that we're Canada and of XX% improve Frozen the reduction talking with about got continue working and of about this growth.I talked a talked year. growth on pipeline. to going we're to going system about We're Elephant we're we're around repair So times advancing LSA as XXX ARCEVO done SynerGraft increases trial to in our approved Asia-Pacific, to take going the showing just post-approval FDA called be technology major data where we'll patients to On-X couple also arch and the there. starting total an supply, well to going

Thank aortic continue excited company an XXXX. to again So are build about for we you delivering in and you.

Operator

today's concludes teleconference. This

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

Artivion (AORT) 15 Feb 242023 Q4 Earnings call transcript