Earnings call transcript Q4 2022

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Operator

Greetings and welcome to Artivion’s Fourth Quarter and Full Year End 2022 Financial Conference Call. [Operator Instructions]

It is now my pleasure to introduce your host, Brian Johnston, Vice President at Gilmartin Group. Thank you.

You may begin.

Brian Johnston

operator. Thanks thank the and today. for you afternoon, call joining Good

Pat management and Joining Artivion's are Mackin, me from team CEO; CFO. Ashley Lee,

Reform Before Private Reform and are the that Act look make uncertainties to XXXX. Comments with that requirements I'd in Securities this statements of Act of the meaning begin, call on of Litigation comply of harbor the within time the Securities forward-looking Private forward Litigation statements made to XXXX. the safe we following like involve risks

forward-looking statements differ made and forward-looking estimates number statements from materially the or include or a management's as statements. uncertainties, to These company's The predictions assumptions these forward-looking to that intentions, statements future. expectations to risks, the are may subject hopes, cause beliefs, of results of actual

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

I to that turn over Pat will With Mackin.

Pat Mackin

and Thanks, good Brian everyone. afternoon

Our XXXX, our I've we into March driving shareholder of years, by in few expanding further market. products, developing day, detailed over products in of you strategy value the substantially new innovative discussed increase our to create geographies, to which investor sales is significant pipeline which within and our innovative at past with of our addressable

that. doing you As are hear just today, will we

the And interactions on received front. the our progress recent significant FDA, that out the BioGlue approval growth XXXX report full that new to are with revenue report I'm PerClot. CE we of the we also the year regulatory made our business and confident we continues we full will for pleased under year based pleased closed mark conversations well just I'm the constant to framework. MDR perform over to with compared currency X% receive to XXXX. We as on

quarter, represent XX% expected commitments, hear to our that a remain constant continue grew EBITDA track XXXX line to and revenue and top forward. stent performance and XX%. our saw Starting growth which also grew On-X with with major the revenue strong to year-over-year deliver we fourth You which currency grafts step we on for

year, the and basis, On-X stent All was XX%, compared down tissue XX%. up up was are constant was grafts up full processing For BioGlue XXXX. year to currency our X% X% full

strong, As anticipated below was the fourth quarter the growth growth three X% but year. delivered quarter constant revenue quarters of of XXXX currency first the through slightly

for BioGlu quarter. customers in these have that BioGlu BioGlu mark would believe accelerated we because based was QX, unable some we mark. we was made prior purchasing million constant CE in return made and X.X fourth growth on mentioned regular If fourth supply BioGlu the around patterns extensions to of QX the protect beyond countries now basis the our total a to and those ordering CE is not this increased had year. a on have the been currency to We purchase X% BioGlu compared for quarter onetime EU commercialization our we that in occurrence where anticipate the to call approximately of have customers the the in derogation As quarter on purchases October your deceleration would customers in EU the expected the into XX. third our had quarter, not our quarter otherwise they event, fourth the for done BioGlu was company This obtain fourth

committed day double XXXX three through As growth March delivering in our revenue we constant initiatives. to digit of XXXX key investor at you will recall through compounded currency

Aortic and our growth drive to On-X. in continue we'll stent First, grafts

XXXX Latin America. and will for the And continue approvals regulatory U.S. Mitral. Per-Clot Second, benefit from PMA Asia-Pacific benefit we'll investments from new PROACT we and in in our in beyond approvals in commercial to channels and third, and

The a constant on in rebounded demand revenues to compared with last XX% stent German a nearly compared to is growth currency year. in now year-over-year staffing. constant We As mentioned graft year currency the portfolio manufacturing fourth stent XX% finished graft on previously, progress fourth full 'XX basis, the quarter at for the facility, increase to operating also remains our which hiring at our basis. made full high. significant We've quarter

growth improve result, portfolio. over a stent catalyst believe product continuing As we time will to graft a this to serve will which significantly as our drive in

the As maintained fourth a XX% take market year X.X. mechanical 'XX. the and the aortic constant with valve between remain INR We year, currency in and share compared 'XX for of revenue basis grew quarter full that compared quarter continue we XX% globally on to On-X fourth heart X.X only to last confident be will to can and

XX%, next also currency executing America year for Latin our commercial Asia-Pacific on XX% XX% and initiative constant very and will expansion. and and expand respectively, growth XX% respectively. in presence APAC full regulatory revenue well America approvals Latin to had quarter and the through our footprint new fourth of and We

these the be regions growth expect coming drivers to continue years. over to We important

Regarding our $XX product. for the product $XX Per-Clot a Upon a to million net of a million on amounts with former recent will then commence third shipping discussions our we we we optimistic we approval, are based receive PMA partner Baxter. or and that owed initiative approximately to FDA, receive

to our the XXXX. is of believe growth outlook growth a forecasts. that to not second year. dialogues achieve are in potential near we and relates this with included and as approval this look ability term We've half imperative maintaining for potential to do We the in revenue our our it the Mitral PROACT longer forward securing As not FDA interactive approval approval

in each the one a addition, trial debilitating second onset enrolled in renal the Nexus aortic of assume our year We've infarction, anticipate includes approval trial clinical in patients The and new this patients progress trial, up dissections. efficacy year combined stroke, experienced meets mortality, the endpoints PERSEVERE non have U.S. up in who acute our which dialysis is trial a are XX PERSEVERE aorta. of failure to centers following and full with make of which enrollment safety we this reduction In partner. and for the its clinical primary XXX AMDs endpoints pipeline, FDA randomized all to our and true period of lumen progress continue in receive the requiring the expansion trial of of we XX initiatives, We these myocardial three half re AMDS our of cause new now in would the trial XXXX. completing we anticipate follow type of

previously arch patients in enrolled system. in total that estimates XX stent completion Nexus enrollment treated Endospan approximately In the on making US In TRIOMPHE there treatment. our PMA enrolled are and called approved patients XX for addition XXXX to with that a its aortic graft is the again, market stated, partner for products and progress mid ID trial Endospan expect and FDA $XXX approval for At would To XXXX. in hits that its Endospan by estimated succeed our an XXXX, AMDS in option if proceed increase PMA reiterate trials endpoints. assuming these opportunity as anticipate exercise approval we assuming our NEXUS we addressable time, million. anticipated, as these or for trial,

I'll Ashley. now turn With the over call to that,

Ashley Lee

currency GAAP fourth $XX.X everyone. Total X% and a XXXX. quarter of basis good constant both and on for the million basis to were compared afternoon Pat, flat a on QX revenues Thanks,

On-X year-over-year X%. year, a Tissue X% quarter constant increased full basis of basis, the XXXX increased a revenues processing X% revenues fourth and on On GAAP in currency revenues on increased X%. the a For basis.

Asia-Pacific America revenues Aortic On increased XX to stent currency X%. Latin in and of the tissue XX%, fourth EMEA constant and fourth to On-X North America of grafts quarter and a basis Asia-Pacific increased On XX%, increased X%; fourth currency decreased to the decreased BioGlue XX%, increased Latin X% all North of X% increased to grew XXXX. compared grafts XX%, revenues increased regional quarter grew processing a increased compared fourth all On decreased X% XX%, XX%. basis, BioGlue constant increased quarter basis, America in XXXX. America quarter a compared revenues XX%, stent and X% XXXX grew XX%; Europe the

from rates continue gross 'XX. we approve margins prime and prior XX.X% and after the margins, which sequentially driven and aortic to that. year product quarter by to stabilize compares decrease while quarter to mix labor, the them inflation compared the as QX improved in on third then earlier materials impacts in well XXXX margins of was persistently expect within The remained our gross we as stent XX.X% to inflation weigh for fourth our high on globally that improve believe to line, graft and Gross

XXXX. G&A to in $XX.X of expenses in million were fourth the fourth $XX.X quarter the compared quarter million

fourth If quarter the of non-recurring launch the business $X.X the the which 'XX related and inventory. expected to XXXX of acquisition will were to fourth of with for have XX.X $X.X Per-Clot million XXXX. fourth in of non-recurring to R&D development Baxter expenses XX.X quarter majority Per-Clot million the $X.X expenses million is other of quarter fourth cost were for XXXX. million of expect, associated the sales. XXXX compared the we in pre G&A sales approved, charges include goods R&D fourth million benefits for Excluding no then the in compared for quarter quarter expenses Per-Clot

EBITDA costs them earnings We treated calculating recurring and these have as share. excluded per non-GAAP for non purposes of have adjusted and

and expenses million. translation $X.X currency in include foreign income of and expense, gains Other million $X.X approximately interest net

$X.XX of and net On the the in share per or currency charges. gains, income Non-GAAP $X.X other reported million excludes and the Non-GAAP development quarter. in foreign of million $X.X chair $X.X per business was net income approximately income or we GAAP diluted bottom line, quarter fully fourth fourth non-recurring XXXX. includes

full had to facility. us million fourth for in non-GAAP million to XXXX additional of million XXXX XX, $XX including results we As to these to GAAP million a and for the information the debt XXXX, to $XXX million about our press quarter year of results Please revolving for results. cash, our was quarter approximately full our EBITDA $XX.X under the was compared $XX compared million XXXX. available XX.X of Adjusted refer reconciliation fourth December EBITDA million our adjusted $XX.X of release in credit XXXX. XX.X for

our for And outlook. initial now XXXX

of XXXX. for currency between X% constant full of revenue and expect XX% the We growth year

million to that range timing $XXX toward of be We the upside move of of expect could We increased the end following staffing supply the range. us PMA, Germany or key revenues million. this Per-Clot a see as higher timing $XXX lower factors of in to and production in

not is could contribution and As Mitral included revenue further PROACT in noted from earlier, and represent outlook, XXXX our upside. approval initial

TMR pieces We in TMR pieces, prior we Our We options guidance contribution this us to expect business for therefore to evaluating any revenues with indicating sole are but contribute our also supplier none from TMR, effective no supply longer currently they will our exiting XXXX. communication and that recent revenues source a received from reflects would for have hand hand immediately. minimal are XXXX.

last line to product generated we not growth. and from a year million context, For approximately TMR meaningful in $X long as impediment this therefore revenue term do the see

first For $X the compared an of quarter, currency XXXX. we the million see revenue to first approximate expect quarter to headwind

our meaningful as recent year we giving end synth of first range our Additionally, guidance. range fully be expect hires time growth, of to contribution to the the growth guidance, in of in half Germany revenue year revenue expect graphs the the growth will to the be closer of become our closer the revenue then of We of end for half productive. take to lower to of the to second higher

and revenues XX adjusted R&D This anticipate dollars. plus XXXX EBITDA continued we meet us a our March of invest our adjusted Further, obligations, on we line be a XXXX did the raise increases year to our debt able need XX the Even plus capital track last to expense With put decrease general growth. we not X%, in in our in approximately in if EBITDA day. to in made minimum should channels will our investor comfortably delivering debt in service of and additional and at commitments to to to or pipeline. our management growth our fund to top investments million percent our we see spending, SOFR growth continue

drawn would any quarter term on more our of which do default, place contains calendar facility we that not. revolving financial have us credit $X.X were our the end no to million at in we than And unless B covenants loan finally,

the As of million need on foresee full it. not XX under now and our the to credit available we draw have facility, do

not our covenants. notes convertible financial Additionally, do any contain

comments. to his I call for closing over back will turn the Pat

Pat Mackin

staffing particularly our We're things, of XXXX and entering Ashley. with Thanks, including, significant performance XXXX in macro among multitude pressures. position headwinds, our and other considering the COVID inflationary pleased

results Our growth working is the on strategy envisioned. we’ve and delivering

the To summarize graft return to stent growth our business strong fourth in quarter.

PROACT to We staffing significantly recent hopeful Ony-X in expect Mitral drive And and that continues we’re growth. improvements to later approve future perform year. benefits Germany well. supply this

and forward. we moving Latin and America outperform of Asia-Pacific more same to expect the

NEXUS And we’re BiGlue we for approval growth two Our over for addressable to $XXX drive have trials our expand should option. execute are these U.S. by Endospan two we’ll that million MDS currently our soon the and Endospan mark clinical Per-Clot. expect CE we Combined, on total PERSEVERE TRIOMPHE very optimistic in recent in and XXXX assuming enrolling. market products

compounded on create growth, we point, from pieces on million continue $XX XXXX, adjusted to and can Through value. shareholder we we for to gross $XX to growth execution essential face grow times annual and than focus revenue a generate to million to less leverage three double net headwinds in expect this impact EBITDA margins. have the At our reduce and sustained digits inflation its on basis to in despite our place the

thanks position and leading a our innovative solidifying to leadership as repair, our sales team. further are experienced company products, aortic accomplished in We organization,

confident all continue. will And continuing deliver I employees thank Artivion the help. the endeavor of to world for to who our are we to for positive our around want momentum We people

operator, open line for with please So questions. the that,

Operator

Street. Thank Our a from and with question Lake [Operator conducting and line of Charlie the question proceed session. be first question. Instructions] you. gentlemen, comes we will Montang this your time, Ladies at answer with Please

Charlie Montang

Guys, congrats quarter. great on a

you questions about how quick is FX kind headwinds comparing My numbers. when mean one can might be couple when I moderate in remind year-over-year those XXXX? a on for us Just to we USD impact first start me. should thinking of

Pat Mackin

one. that Ashley I take you let will Yes,

Ashley Lee

obviously that that the Yes. tailwind it one half expect where Based second A on could depends impact on a rates the of that primarily of are our beginning relationship because is has moves the us. on the most actually the become outsized currently, in year, Euro-USD for where we lot FX business.

the at, where expect, year. half on what FX depends move. again, ultimately we become for in it second based again, looking a of But tailwind the we’re to on So rates currently us

Charlie Montang

Okay, great. high to should mid And standard mid teens are with stated analyst that then Thanks single there to And surgical low digits that. for seeing Does is day and one next that this single the case? the that low XX% could is last my on your clarity anything remain On-X sealants you digits. on today preservation grow teens trajectory? the alter

Pat Mackin

XX, at growth roughly last of I one. we kind if for stent what mean we in we look for presented that at projected take XX% came XX% grafts, you I’ll of back March Yes. year XX% to roughly in year. the

XX end at high of range. said XX, that the in at of of So On-X we midpoint came kind XX we to that.

So derogations we year get longer BioGlue obviously contributor of than that in did we we get of us the countries We the high thought. took big we we took kind it at through CE entire in process end that the The and one was had an several mark MDR couldn’t line. a Tissue only derogations and mid X%, that then range. of that get the countries well that. us it came in the to was single, disappointed fact at

got the the right That’s mark great So behind the is news BioGlue of year. at us. all we the CE end

We BioGlue an now have about that we for CE have to and MDR mark don’t anymore. hear

at full the I we of only of low lower So year. single that for to one was the back digits and the BioGlue were that think of the range outlier should really reasons return and end the kind

Charlie Montang

needs one Okay, what done? great. chain to stent within one of and Thank resolved here. not supply you. kind business last the if be The And issues then just quick else

Pat Mackin

mentioned comments. a this have. problem my in it’s obviously, good I Yes. It’s to

one our a that this And it a high some our factory the is of have major we challenge. end at issues Germany. graph had such growing strength huge We partly growth products because demand in portfolio. bit our innovative have on XX%. of range we’re And We in of of hiring

all as up being magically people actually trained. we to We of changed get a in takes of find is, They rates, a inflation rates, we action. quarter. labor in it number sudden, trained bunch we the the where again, our XX about hired are and people And of and fourth people couldn’t days a speak, lower we find this at

see as strength Ashley hopefully, that continued where chain as get and we and commented, the new of beyond growth, chain to in we, we kind we to our employees supply trained So support even should going the supply expect are primed. manufacturing getting

business. So throughout we stent our should graft growth year on probably see increase kind of the

Operator

Bert, line question from Please Jeffrey Cowen Our Latin proceed next your of with comes the question. from Dolman.

Jeffrey Cowen

the ‘XX, in So as ones, not in as or you including you few including guidance quick that range? for far goes as Per-Clot are

Pat Mackin

in range. the That’s

Jeffrey Cowen

it. Got

talk you like remain chain, can challenging. Supply bit? seems margins then, will And about ‘XX Okay. a it

Pat Mackin

I the impact. mark BioGlue one kind of mean CE forever of taken last margins, Yes, our I inflationary mean other the year, than

the and was headwind increase labor, faced. XXXX, ‘XX of directly that of gross cost pressure. So XX and decline, around mean, of margin. at of XX, rates so point inflationary one the really a finished And challenges basis finished about materials, the related about labor to I a kind XX%, XXX our and we we all many companies a as

product exactly a good the are these our that long in just kind like suppliers not with lot So are margins been we’re in in. pressures baked this, kind I flat baked about covering planning product company mean down. But go this holding around the that future. mean, TMR, The our decent thing. lines multiple nonstrategic, it for supply those TMR But mean, on was those we of and had somewhat you’ve of chain a we I them time. of older inflationary talked year. was I a gross margin.

good really it’s strategic. worth. have probably more a effort I And such it’s we And a it’s that, product, it’s small of and it than of not because the think kind just, that’s don’t example supply infrastructure supporting chain

We’re we we’re whether next years. to a or at two that. going want from revenue for TMR evaluate not to going revive not the minimum, see to But

think every don’t but day, good infrastructure have but So of that I deal have stuff of kind we growing we’re that’s example kind supporting with happen. We on a lines, where can around a we of able faster larger product a strategic good focus to our it those.

of manage chain part job issues. to that’s our those supply So

Jeffrey Cowen

more lastly, the color in Thanks. of as seeing? you’re growth VEDA Pat versus far And there Nexus and for some Europe then us, as reception it. platform any on and Got presence and what stent and graph kind commentary out

Pat Mackin

in we’re really once those changed mean, and in XXXX, around quickly in filled year growth. we market seeing had being are our in the and our we hiring mean, mean, because to decelerated there I the over trained I were Yes, with supply. as German summarized people went factory I mentioned earlier excellent those hard and rates, because quarter product up facility rates, Germany, moving we to sales of the kind on line I a we of as my, primarily around team running hire get able the very fourth now. time in labor

product but the continue where frozen the time. the make trunk in an that such to got for I long be offerings in product to in this sure in got up the all as really growth growth the for we got opportunity unique for it’s the can time. our call And area it the arch, thoracoabdominal of good across we two and we’re needs to that’s drive technology our we just on seeing extra really what lines, period a inside we products far mean, of So, as one and Neo of all we’ve elephant design,

Operator

Please of Stifel. with your from Our next proceed question comes line Wise question. with the Rick

Rick Wise

Good Pat. afternoon,

A couple of questions.

I chains, the the you? led been clear absolutely the you just how should getting be about is we of simplistically that mean, about effect, again, they’ve go staffing, that a ‘XX. that path driver over I I A macro. make wondering, characterize sounds lesser in less sense better Again, make it year over say so as like I’m would clear wanted being hearing messaging. supply just and the unfolds, for to think I things was far to an a to felt stable the reported issue, I companies Sorry improving have lot environment. macro should Germany and when I have think in I’d key general sure currency, about it, real we’re hear on talking

Pat Mackin

Yes.

the you just made So never I about of many of XX headwinds. this, think in if doing I’ve had macro comment a years about as number

you You had had COVID, staffing hospital striking.

you pressures, pressures. currency You chain had pest had pressures, inflationary supply

So was I lot, there up year, and stuff given the the was thrown a at given all think us. actually we put pretty that a good

those, trying If of you mean, you read what’s happen. to inflation kind out papers, I of to kind going the unpack can figure everybody’s

We XXX our think answers we gross feel be year. took be we to point can year, this and whack like going inflation that we But margins last stable are basis flat your question.

I don’t So don’t I we’ve COVID got COVID I kind it being of baked mean, in. even issue. an see really

again, happens but the in really Now, I knows see just future, what who it. don’t

surgeons and here seeing of We’re lot a nurse talked had and Stanford I there. get a nurse and the at Mount Sinai done. had had our end strike. and a I nurse procedures the to Minneapolis strikes mean, And strike. day, staffing a there’s strike And

our a strike year. two, to for they a in it’s macro change or not going volume whether procedure So week

repairs I of heart health that that in systems the are out have and kind disarray. don’t see. right, aren’t valves. noise So these a are lot But I of aortic UK mean, of These arch emergent. heard again, facelifts, NHS we

we procedures to think the proven to, get tend pandemic, this I So done. our we’ve and we tend through actually,

think I in better one So that say. is

currency in half. the comment think Ashley second I on

the just But they than of I And bite mean, and and But to product think to a that. like kind it’s in in lots TMR, the a is chain you. last do strategic manage your teams jump noise line, much it’s stuff are continue place better a kind manage supply point, of So of a having I product I doesn’t that to hard I think chain old drive supply can, we don’t the business. There forward. stuff we’ve it non hood. a of think be involved you think probably much got And Yes, these in under of simplifying can year. were example going a lot of revenue. way to up to have want lot the an I the drive good

Rick Wise

for sure. for top about what some take priorities us in sales think Yes, doing Obviously, blocking do and just XXXX Can portfolio? year? portfolio? aortic great. you are the to of through for key the your tackling guys? stent add this graft the drivers couple extent How we is What important you’re to of Is it that it

Pat Mackin

that Yes, our of our them really four graft it’s products portfolio, so and there fastest differentiated stent growing is portfolio. inside

So if Neo kind top well. device side, extremely the from our doing on of aorta is down of the surgical go you

combined one in We’re businesses, And also that America street adding in and but drivers. as the Asia-Pacific Latin Asia both Latin saw was there. and new opening growth tremendous feet markets up of we’re America. the We on underlying

tail some stent and We we two as which is well. very our that but growing launched device add the Nexus generation second here continue Duo, We branch just for the growing to there market, fast quite graph arch, device. people a Neo is see a

two clinical that the device branch the just that’s with getting familiar current very you’re The very, that’s in this got denominator of our a Europe a views. you’ve in U.S. is single in with that branch work got some positive launched is some limitations. was In Nexus from physicians. We’ve trials done

then international Taipei’s to Canada key spanning And with extra to is to U.S. things a and on is get obviously, continue that are expect design a in data growth hearing thoracoabdominal anecdotal The people for offerings. basically be And very surgeons made we’re are anomaly. and more is of approved rapidly. shelf can some of oceans, more them. that our which Europe, which is then custom combined, PERSEVERE from player in driver. the dissections, the the really markets handful off two about acute segment really enroll, kind only in we inside. hearing thoracoabdominal and across The that the a out kind continuing And device. AMDS We the growing of any treat we of we’re

it’s the where a treat But I may said, patients, or four factory So half kind And unique of It’s they really we surgeons some that. very and have now with those we little to the it’s like portfolio. competition, in can’t one love up very have technologies, some we filling last allowing two. of challenges the the treat of had companies. other second year, we’ve resolved them

it’s just trained. can we reps grow So a as as up continue significantly. we those long getting stem And employees those pretty will and really business training, to feed that graft

Rick Wise

Got you.

correctly, all feeling million that in now. for Just number day at me, more from helpful. XXXX. aspiration very about term How you appreciate if long you XXX don’t couple a remember mind color, I your and If your the about guidance the analyst you’ve talked

Pat Mackin

I think, mean, I yes. currently, Yes obviously

Rick Wise

great about Great maybe. so not

Pat Mackin

have I decline in in as I didn’t business to was going of Yes, March, it we year, XX%. I the chunk know we our obviously learned Euros. year big a last mean, that when we launched And

I you’d to more of revenue challenges a think were on know, linear. XX% the say I we thought in could grew next lot average, over chart shale the we XXXX. that as never businesses basically three years. year. to, We would There are you what showed have is It’s grow never nine So this

And we’re XX. guidance, you so at I and X look think that between XX% our if

We’re over three have a shooting we that CAGR. XX% years the for

that’s including of I n think a the within currency for that are for factor rate. a us. factors big XX% think what lot well number think has I again, reach we growth company. And the holding But I So to our is

Rick Wise

to just wanted make just just I last, Okay. being And dense it. again, I’m about sure, maybe

Mitral, to before. think I of PROACT guided end the ‘XX You

understanding there? it’s the factors Why second to XH, half, much. why delay timing? so Why Thanks been about the sure ‘XX? And Now are what delay? confident are you I’m in

Pat Mackin

Yes.

good So it’s question, a Rick.

And so for them or year. the end we the of about hoped we of had from had hear two the both PMAs FDA, by and

report that to the we thing’s they going get On the on to approved. FDA happy from I’m basically news, good said, this heard Per-Clot.

We’re basically a were through we steps working been process. I’ve of And these. labeling the of in lot right final now. on the

exactly approved. they us labeling But approved, Now, the working is you mean, told can’t good again, I indicator. exactly, is I pretty things and on tell a when get we’re to going get

if as PROACT And understand trial a Mitral, clean. it this you’ll I work think done wasn’t conversely, here. clean. look because of at wasn’t you’ve as lot you The

endpoint Mitral, bleeding ago. a This endpoint of look a composite you PROACT thromboembolic which a its events. inferiority. was in of ago. It the time If missed at started started primary decade long non It

same that Okay. PROACT was exactly way And done. was the aortic

FDA the And thromboembolic kind two a us and mask a bleeding like miss. because made a can they us better variables primary inferior that thromboembolic, made variables Bleeding it on take PROACT They thromboembolic those apart. non secondary In event, XXA drive the were commingled. event can one of bleeding. performance didn’t

for the less. and that have non had a but the It lower a did that look group a it So you And X. powered but INR X, in we It just in lower at of and to non like It obviously bleeding average the should have I the did there’s enough, thromboembolic wasn’t at you didn’t difference if fact of no INR a One events. the that would inferiority patient was look you inferior. control don’t XX bleeding. get hit bleeding wasn’t how because know group average fact X.X you in around and an suspect would was X.X you was treatment average that a patient X.XX. trial, the a the be

going about trial. you to totality, to endpoint So talking again, when get missed for in well, look I the because have with think, I’m that it’s might all at longer what all I us we think FDA through the data, just the primary it, trying take the

If On-X you which no to of me is the how the have this. a are really trial PI for The over, look data, run is difference look look are me the meaningful valve, telling in To non us. telling it’s and On-X surgeons and that’s events. the patients three totality thromboembolic the at they of at you at compared at and mitral data, can X.X you valve take endpoints, apart an

longer. as So take it’s to as clean. going just It’s not it’s us not

was give reason it’s helpful context. for delay. to that think kind that’s I the some the So you of Hopefully,

Operator

the with your Company. Needham next with proceed Matson Michael from comes question and Our line question. of Please

Michael Matson

thanks. Yes,

market line want for challenge how kind had labor forecast fast and And forecast. I I you’ve sent but guess in second mean, growing of difficult in this that understand This it’s and it’s a there the everything, time that is you that to of grow. kind going with is staffing in really Germany, business have kind graft that I So just I of a to business. been

I you happen hiring. ahead what when get differently kind of try do next can to So to you this, you of you’re guess try to time, again this doesn’t

Pat Mackin

is think bankrupt this again, And I back, a It’s a Mike. business business ago. this involved going question business of fair part ran supply Medtronic chain. this I Yes. years It’s with been I’ve very XX complex

and together, to an have put different you ship come case, six pieces five sizes or If may in three different may because and back. there’s you individual then two or have pieces,

of that’s a to that. necessarily logistical And up involved it. there’s in we So snuff lot weren’t with excellence

involved where shelf. actually the units on of you lot consignment a put also There’s

yourself. So the can if can you and your of you’re get consignment, in ahead you spread you how in places, units see out wrong

So we that And now. kind firm in us outside of actually going help with brought this. to we’re right through an

going of bed for once. is So I to kind put agree something the with we’re you, this

sure the are as a We’re doing around product the getting supply right accounts turns. of back, chain consignments having excellence lot our as number well about making

supply that going it. a supply of of grow in is whole the going this, to kind to kind put so the point, not factory, to expect fast. And a to because infrastructure don’t on we just go there business back a the also area, But again, to place, going very again, we’re part this is we chain And of excellence. back there’s not chain So project to we’re your have that factory it’s this. in

Michael Matson

Okay, the got EBITDA. then And it. just I’m here on

returning million, XX but mean, for So guidance excess you’re XXXX. is I the guidance in XX of the for for

I guess pretty be million million to come in that to to step if mean, it that growth you I XXXX. XX% a seems to XX in So XX that number, big up mean, closer get almost

up are step XX , kind get XX you to for of doesn’t like how confident more can maybe that quite million year that as that So this and XXXX. million in you look difficult

Pat Mackin

million. I year, if it’s with for day things X we’re I to EBITDA incremental if do kind we million EBITDA mean, to you analyst the were your we the the just So at that margin No, is question, one of math, gave XX a Mike. upside, the again, point, fair going of right? much $XX you doing as you exactly it’s of and the which range of pretty that’s which to mean, and driving we a gross a that said a was number. return XX this gets we’re to what XX%

become in point every on million you million $X of high growth, profit. growth So is as can it as you every we million we to point dollars, growth, get gets that And in want every range. in of a which almost obviously $X of

to the to Because we’re put it’ll to number that’s your shooting but a do. more we’re year, going So pressure be pushing get point than higher what to on to XX. next

Michael Matson

And all this on right. TMR then the thing. Okay,

can So selling a what the quarter. don’t it’s XXXX every revisit numbers, in were so you can’t confusing I I because the that it to because me. tell through that just to know you I I wanted you remember were actual but me just went know. revenues little if

you’ve had If you some, problems. had

Pat Mackin

rough give you we you about some did just give year some million. to Last X So to numbers. XX

any we I going of XXX,XXX until be to more about there out run hand the do for years. two to pieces, think and in aren't and we're going quarter out We’re then first

you need much the that numbers I think know. you So pretty I all think to tells the

Michael Matson

Yes.

intention the back mean, I I is and this dead never But mean. it's comes that or Okay.

Pat Mackin

of is I it Yes. days challenge might the the part this of with few were mean, part a notified just ago. we

for know our to letter I investment. that the and couple just how really actually if done it hand much worthwhile couple I got thing of two other it'll TMR had manufacturers and to a got I time how a making than that. haven't going a of at do just years. some dollars know I react contract to we this that evaluate. mean, have to I we're got we a this us also another fact pieces potentially investigate. going need I'm said, I take don't I is of need not I time know of was and from Like million I it's I time worth see it. it'll to to So if some But that long but going years But supplier, looked do time some cost. kind need it's just to take I

making. So the sausage you got me middle kind of the of in

Operator

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

Suraj Kalia

one Maybe side. Maybe Hope questions all And first for well for Pat. one terms you first into that in of overreacting Am is for sensed overreacting Hey, Doing Pat. PROACT and level I Pat? well. Mitral this, for on I'm the Ashley guys' Ashley question, you some hedging I but on all time approval. On-X. of

Pat Mackin

No, I think that's fair. --

Suraj Kalia

Any label, a approval getting whatever. for high not a or not additional restricted It's risk, specifically getting color.

Pat Mackin

again learned trial composite they A. I mean, bleeding, Yes. personally PROACT think of about bleeding with drove to we interesting in help was, met question, aortic, where the stuff part the than PROACT found probably And about prolactin endpoint. that's reduction is No FDA anybody of is that they Rick's I because What I I and the I designs. more not tried didn't just this obviously did FDA we endpoint in like on like and I the fair. it

me them apart. make just they take Right. So

they we bleeding it, and is did take in which A. Thromboembolic I PROACT So apart. made they is them did really goal secondary, the what us made

is the issue. it was they PROACT the in inferior is what control them arm. anyone tell which when either Even the at you you But way the endpoint, be do two. But are missed also the bleeding at for there And you which was a has shows. three, treatment was the difference that data to no like makes when group bleeding, that's that take there What's interesting thromboembolic event, would which five though is a in the to and we that in big primary it, Mitral, actually more we sense. a apart not is group of composite safety no

So again, with I you of is have as the I more learn the think part yes, mean you conversations FDA. it

of a XX the look have a which think going present and patients between surgeons could care what I so five are And to telling me that XX was that a showed that is was valves year totality in mean, the in we're trial XX is at no you difference you XXX of compared trial we data. thromboembolic should to at to three. standard events at the On-X run that it and

FDA. can't I again, So for speak the

was understand everything think a it I and I We a all why mean, cleaner. get the wasn't I cleaner. much layup. was Per-Clot much numbers

going put just taken happens. forward, case But going see the I We're and FDA what us longer. we'll our to So do. it's best what can't to predict is

published was valves, they of to surgeons I I it the it hopefully the in is think surgeons, I think We're to paper when label. But the talk the sees off see in mean, the there, the and out way. I data promote benefit same the end, December. going not FDA

Suraj Kalia

the the to in again, any XXA remind Pat also when Got to trial line top post, pre that handholding if the was the it. field? productivity as relates you XXA, publication PROACT stoppage On-X post additional specifically sales extent and needed, the can characterize the or it us force and

Pat Mackin

Yes.

whatever Los question like first get in going to presented be to be It's your around news, that X that it's session May, of May the Angeles, product question. week So X, first on, ATS plenary will was hopefully, will XXA going a presented, and this, cover at X, on recent there. first in I I

how intrigued to very as going that's be I a for performs. group, the the it think, to So as I'm field, presentation, well, important control very both see

just you foreshadowing. with I'll leave So that

think from it's I a interesting. very field standpoint,

INR a valve from they talked edge. only on This great they aortic valve, surgeons, mitral force. heard with still like the best And would huge our well out you side. We've today, low went after for all great product were the and sales patients, the ones we surgeons, got aortic the cutting been were still have comments you guys, you're you got and mechanical a

doing. what doing So kind keep Right. of you're

So, it. Neo on is setback. to think amount I is in of again, aortic aortic much other in see a the But Suraj the I'm we're elephant of of that's our we're I sure in aorta our with the that doing best competitors didn't to NEXUS mean, And think space. I think class. investing to Everything heavily I jump don't things On-X will to try I company, an about frozen trunk mean, we're nominal, from field. platforms AMDS, and to piece one

really think any I force sales holding. didn't require are to again, me, we hand So

Suraj Kalia

in all Do Got last throw appreciate way back queue. one, questions. Ashley And your and my in I'll you jump it. guys taking

very Ashley maybe it. U.S. I much. missed you On-X Thank What the O-U.S? split

Ashley Lee

is on gosh. Suraj. roughly it's you get the I think exact It there. XX/XX Oh, with split. can approximately back roughly that But I And around

Operator

management to queue. closing There like the remarks. in are call the no for I'd hand back questions further to

Pat Mackin

pipeline to drive America and Latin forward. forward on significant and Well, in thanks call. driving growth strategy for our forward growth looking bringing and attending our the Asia-Pacific, franchise We're to graft our On-X stent in continuing the

quarter, thanks for joining. back next Bye. be you at Bye. we'll and So

Operator

Ladies does today's you conclude this your teleconference. participation. Thank for gentlemen, and

may line your You have wonderful day. a and time to this disconnect

Artivion (AORT) 16 Feb 232022 Q4 Earnings call transcript