AORT - Earnings call transcript Q4 2021

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Operator

Greetings, and welcome to Artivion 4Q and Year-end 2021 Financial Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to introduce your host. the to turn the Johnson now Group. Gilmartin will call Brian over from I you may and you, Thank begin.

Brian Johnston

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

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

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

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

over turn to Pat I'll CEO it Now Mackin. Artivion

J. Patrick Mackin

the is and vision and and afternoon, years for CryoLife our position we aortic for Hey, and as the innovation to aorta, This from seven and of from our time thanks, be treatments words vision was maintain evolved as continually Brian It change innovative providing good significantly name reflects our joined disease, ago. since leader global Artivion. the leadership. innovate to evolution a to joining call. us rebranding our I thanks call on This first was to derived our name

was and many CEO currency compared XX.X% basis basis. pro will $XX.X vascular and repair have aware would just on Investors our CryoLife more we globe. significant quarter in and becoming we to series the focused believe new the with the continue company. and our revenue seven of our Through up Revenues forma all compared of other company encapsulates place and currency our we since on done goal do collaborating transform a We transformation. quarterly the growth. by XXXX strong to for around who we years that. now our we've success A fresh and that were can past Revenues into Artivion, of followed our so significant aortic and solutions organically with of not about our to expect come are innovative we years, XXXX of our strategy most those up and I customers at physicians the to will basically to as these just XX.X% today. on rebrand learn to Artivion posted During access that quarter each since employees transformation therapies My fourth acquisitions patients development midpoint grow believe our taking our pipeline come. and see guidance. of on XXXX. the and a a fourth challenges, investors constant We assembled sets the fourth customers well we've up continue for to at more for us was to pro Artivion approvals regulatory double future in surgeons have a the that and across new in digits products a record evolve, to product of Artivion, heels XX.X% ‘XX. the as quarter revenue were fourth for what accomplished now difficult look do a We innovative of On-X compete XXXX of acquired pipeline That's portfolio with on to product to market strategic quarter regulatory divestitures as million. provide and continued cardiac the constant any open to forma initiatives, now up

Our stent XX%, grafts segments. On-X stents on stent currency driven stent, as constant in of pro XX.X%. QX basis, QX product by grew grafts was well QX our our comparing to growth ‘XX forma a specifically, as and More grew ’XX, On-X

up stent the Here NEXUS XXX%. up XX%; in are stent the up the XX%; are rates segment. and products up that NEO, growth AMDS XX%; graft of E-nside,

We staffing results from with issues the in as that were pleased In cardiac issues and overflow tissue, with and and business. Delta of all associated hospitals. fourth as TMR also saw we growth continued to quarter Omicron patient variant despite return in our the our are a well the headwinds relaunch lingering variants

on plan through I explained call, our our growth main near to is As initiatives. revenue last term three accelerate

drive growth plan and new to by commercializing and graft stent products. On-X First, E-nside we aortic stent NEO, AMDS, NEXUS, our

regulatory expand beginning and further expanding commercial Asia and Pacific to approvals Latin plan we Second, into channels. America, our

product regulatory first secure Mitral PerClot is use today. hybrid U.S. dissections. line device given for approvals will world's this on A in type an you these arch I and in remain optimistic We of acute through very in remodeling on Starting our to Finally, each the AMDS, the with and the walk treatment the experience update for of China. PROACT BioGlue, three initiatives.

forma the quarter strength approval continued fourth regulatory a on US. outside currency Europe in during Increases and the constant of driven quarter the XXXX. revenues of As pro by countries in increased and over XX% basis were EMEA earlier, fourth noted

compared quarter to NEXUS posted XXXX. increase quarterly on Second of fourth currency XXX% revenues of constant a the basis

well anticipated adoption hospital uptick procedures Nexus and shortages rates the in as staffing with improved decline in we restrictions, travel physician Given XXXX. an associated anticipate COVID-XX, infection in

aneurysms stent newest is This our E-nside. Third, in our treat thoracoabdominal to device grafts. portfolio with endovascular

in Open Plus XX% line basis frozen compared include when Open E-vita XXXX. include a currency grew revenues treat the is NEO a this on This XXXX. basis to in elephant constant and our used aortic E-xtra aneurysms and currency category. E-nside is product newest Our product this Revenues NEO. which QX grew Fourth, Design in on trunk line, dissections constant QX which product compared XX% E-vita and from to to arch. This

seen E-nya, we've less modifications or re-releasing by these COVID-XX virulent, infection potential not have based products become the decided of staffing full delivery the and an product early during the environment continue these or anticipate build this launched We as decrease customer their therefore and shortly significantly abate. system demand Regarding in pandemic. Most for were the hospital shortages hampered to products not of the pandemic make in effects fully adoption before anticipate COVID-XX will to and input XXXX. to improves, market on

AMDS pandemic, the experienced benefited also NEXUS our and addition, launched Europe. both from sales In in before shortly while force they more larger

our I products, have Given the we received positive lines would our growth absence newly product these even in pandemic. in feedback, the greater in been offered believe of the

through initiative, expansion strategy. and pleased Latin our well Pacific are on executing regulatory that America new on Moving footprint Asia next commercial expansion. I'm this very in international and to approvals to report we

on quarter XX%, Our in Pacific increased America quarterly a fourth respectively. by XX% basis XXXX. over constant pro currency the and are forma of revenues Asia Those Latin and

to to over the execute be continue expect growth important continue years our to coming we as on We these the strategy. contributors to regions

achieving regulatory make progress we in to on markets. major our approvals Regarding third three continue initiative,

under our the On-X first valve. mitral label U.S. If FDA a PMA levels for to is patients. lower will is to currently it We've attain Our supplement believe submitted we and benefit clinical review. approved, is a label for the lowering new our be anticoagulation INR significant

We FDA. are in active dialogue with the

during mitral the If do and On-X XXXX. label we done as on expect the with On-X PMA believe we've for U.S. the approval significant the to just mitral share for to receive our valve. INR like lower continue we On-X continuing We valve the aortic label take lower market are sometime will INR valve, with to aortic valve, in approved,

We're PMA years you For to to PerClot, approximately FDA We working the approved expect filed FDA we'll know as two of closely approval the thereafter, generate still half the supply receive the and with FDA. revenue. for during quarter. XXXX. Baxter If the with we second from PerClot last

pathway for in approval we it clarity months. Lastly, the expect possible more remain of approval China have the couple as actively BioGlue to about within a with engaged to relates NMPA regulatory next

our make These three quarter. with key strides and currently these U.S. pipeline, our PROACT in clinical to later the of are addition In midterm each products trials in continue NEXUS this in in start to products also initiatives, we others to Xa, progress expected AMDS.

we by the enrollment should randomized if We XXXX. approval our trial the late endpoints, enrolled FDA, approved and has our than in the end If patients under warfarin. the continue been early the progress aortic meets feedback we market PROACT achieve we valve around believe ‘XX assuming by become rather patients Coumadin effectively ‘XX. to aortic completing patients of versus Eliquis significant for can enrollment determine in We FDA valve patients surgeons the in We age anticipate the indication can second excellent. the leader trial this the XXX of Eliquis And this currently the participating and and or on of aortic On-X quarter valve, believe new Xa to make safely market share have in be is using XX. its in from On-X with trial, clinical This trial. trial maintained prospective in

in clinical The received pivotal approval As PERSEVERE. for called we to a XX is begin sites trial recently up U.S. the non-randomized our FDA to in trial AMDS, clinical trial PERSEVERE

We as and aiding of re-expansion and enrolling a dialysis, enroll for quarter new first we’ll FDA full late all-cause in who've disability year. endpoints end aorta. new-onset this we anticipate enrollment an combined approximately expect myocardial year this the safety acute period, mortality; D, trial completing follow-up efficacy ‘XX. reduction of With renal of We to the are receive XXX A approval the infarction, human by well the anticipate experienced failure AMDS The as one patient Type and in requiring the participants true A, primary C, B, stroke, dissection. the

PROACT Endospan called IDE for In their investors progress and how on the NEXUS trial made the to update about on as partner, they're to our AMDS wanted well trial, making TRIOMPHE. addition the Xa also as we we've U.S. trial progress

anticipated. recall, to potentially the secured we resulting Due slower from delays in than you’ll enrollment acquire primarily pandemic, option Endospan. TRIOMPHE an has As the been trial to

NEXUS enrollment FDA approval until at As in and we completed a do the review sometime system the time required believe be sometime the and trial XXXX in follow-up not in the anticipate PMA for earliest, for We not approval. XXXX. therefore do submission until result, given will

purchase more out market we capital as decided color at to we PROACT also pushed each of and Given least call to ‘XX as potential the I'll provide to will to charge. proceed would bullish With anticipate and related approval during trials Ashley FDA three in this associated his we've as an on pandemic, well $X.X remain the over the and option still opportunity anticipated, value our or the late into we proceed. recorded AMDS Endospan comments. NEXUS technology Ashley. if by said we NEXUS now turn that, increase by Accordingly need With year addressable If market these delay, for impaired challenges the which of adoption associated one billion. an fully that ‘XX the estimated Xa,

D. Ashley Lee

a revenues XXXX. stent of fourth million increased revenues increased fourth revenues revenues stent increased stent forma X% quarter the XXXX, Pat, and basis, to a Tris a increased benefited compared aortic revenues processing processing currency GAAP pro XX%. the On tissue increased cardiac currency constant increased the And and were compared XX%, On-X compared X%, increased basis of On-X, stent XX%, on On aortic America Revenue the XX%, increased increased to $XX.X the has America quarter and forma XX% increased XXXX. to quarter Thanks, XX% increased On XXXX. were of the in revenues the all TMR. of from BioGlue from relaunch Pacific XX% of XX.X% our fourth stent constant the and revenues to to volumes BioGlue pro fourth currency procedure anticipated On fourth the XXXX. tissue quarter, from XX.X% of The increased expenses On-X on constant by graft fourth fourth processing stent and impacted a increased and a a increased EMEA were XX%, forma inflationary the decrease Europe Latin X%. XX.X% relative North fourth quarter, inventory basis, in of million aortic in XX%, million, forma reflecting was $XX.X graft basis revenues compared graft driven tissue XX% revenues basis and revenues new compared tissues of quarter release to and increased America Total XXXX. On in grafts, Gross regional revenues by XX%, the G&A the XXXX. the pro in impacts. Asia margins fourth X% the fourth basis, to XX%, revenues revenues increased reflecting and and up revenues good quarter increased procedure BioGlue XX% pro afternoon product stent quarter basis year-over-year constant XX%, a increased the quarter up $XX.X all hold of quarter stent and Latin XXXX higher of compared XX%, volumes Pacific fourth XXXX. everyone. and Asia quarter and XX%, improved in of obsolescence strength XXXX benefiting quarter for launches. XXXX than aortic currency quarter in revenues both for On-X increased fourth and XX.X% America in compared increased to to fourth increased North tissue

expenses Excluding non-recurring consideration to million the the charges and in charge and million to a related $X.X a $X.X XXXX, G&A development in excluding charge of non-cash value related primarily Endospan charges XXXX, and million fair which XXXX were fourth XXXX. consists business of in impairment $X.X acquisition-related non-cash adjustments the $XX for fair Ascyrus of $XX.X in option, quarters contingent for and and value million of adjustments respectively, related non-cash $XX.X million million to purchase Ascyrus, primarily

and the purchase foreign related spending bring investments future, an that B, relative both included to expenses in quarter of The approximately and to stock impact take U.S. to fourth to growth. evaluated of appropriate million Xa SG&A sales closer the interest $X.X the our compared purchase spending pandemic relates $X.X related $X.X expense and NEXUS, our quarter the quarter, of in the as million in trial million was translation compensation increased loan pre-COVID related million the to of commissions, $X.X debt, quarter and realized for and operating to fourth and our $X of and charge. $X.X levels in allowances pipeline our determined to future reflecting With against primarily cost. XXXX, option expense it expected expense price reflects and $XXX,XXX deferred in and R&D tax we debt Other Income physician the increase forecasted the the adoption of expenses in returned convertible in includes expenses, losses. amortization PROACT the results aortic origination our to approximately support salaries, personnel-related of including expense additional historically million were stent remaining Fourth million travel, fourth impairment and assets. QX unrealized valuation $X.X in to term currency tax million to

earnings currency $XXX,XXX, the share quarter. a of includes compared approximately XXXX. reported million quarter $X.X million, to $XX.X GAAP per quarter translation of was approximately operating the business and fourth loss the amortization $X.X non-GAAP backs net On per income. line related of we non-recurring income of $XX.X Non-GAAP of $X.XX approximately losses. Adjusted net loss to and operating add foreign ’XX, bottom the $X.XX reflects was million Adjusted income expense, the for per development for operating other share charges million diluted in loss or fourth in fourth or GAAP or quarter. fourth share $X pretax

facility cash, was million fourth $XX December we of items, leverage, mentioned XX, of for Pat $XX.X Net balance defined $XXX million Adjusted for the stood quarter our available relationship. million XXXX, under On of our and our X.X related quarter had facility. the other to EBITDA at million, fourth credit $XX approximately sheet times. Endospan in compared debt, million full credit $XX.X revolving XXXX As as in by the XXXX.

impairment As he commercial in the delays opportunity. of Europe an option mentioned, value and to-date, to in related given traction pandemic-related this the we recorded

and a to results any refer results. While our year we by results information timing additional clinical later. acquire to to one non-GAAP XXXX remain for need GAAP delays this these least now XXXX our including initial reconciliation Endospan And or positive potential on to deal any about out release press product, for our our push of associated at outlook. Please capital the

revenue and of growth XXXX. Using to X% $XXX be rate $X Euro-USD of currency for between the constant to are expect compared XXXX. a to rate The of full headwind XXXX, $X.XX, resulting XX% was expected $XXX million. We exchange exchange year Euro-USD Revenues million a in XXXX for average in $X.XX,

during environment COVID of balance quarter surgeries shortages of impact in-person staff deferred limited assumes the a operating the to an normal guidance this first the and more and return year, year, a more for Our from meaning selling. and

Although not Asia EBITDA debt anticipate to a R&D, can will call XXXX, and we we margin improvement channels America, commercial pipeline Latin in to to in comfortably raise continue and invest operating and the for significant closing we our in Pat his back that our having do capital. our additional turn adjusted comments. in believe I service without

J. Patrick Mackin

Thanks, Ashley.

move final we with take I'll few leave questions, your to before a So you thoughts.

business team we COVID-related growth revenue products the believe in to place and posted trend. is we Our have headwinds. momentum strategy, the year-over-year continue We despite just the strong that strong,

particularly momentum into this into expect beyond. quarter We the and second continue to XXXX,

through short of drive As will growth now ‘XX. term initiatives explained have we from the earlier, that three end

and E-nside and our First, we AMDS, new NEO. should see grafts, continued growth and aortic stent in On-X, stents NEXUS,

and for our our Second, regulatory we in America. Asia channels upside and Latin new anticipate investments further in approvals

enrollment you'd will by New approval for our all on encourage Investor our any we to line approvals an have open that pipeline R&D or PMA U.S. more PROACT midterm excellent XXXX, total in Analyst three you robust currently with investors@artivion.com. March start on U.S. Relations Day receive we trials, our please late I three and we these you products, strategy, PerClot questions? our finally, enrolling, billion. AMDS, On-X If to i.e. our into in of a Investor our questions pipeline XX. ‘XX like Operator team City are $X.X join opportunity at us PMAs addressable market PMA Third, to PROACT the in in in ‘XX learn And you the and for projections to about expect our or in Xa, team. enrolling, will to expand three or for about will please be leadership and attend TRIOMPHE or NEXUS out anticipate for Based to person, for York PERSEVERE. reach Mitral It

Operator

Thank session. will question-and-answer conducting question you. At with Furlong this Morgan we a time first from be is Instructions] [Operator Our go Stanley. Please Cecilia ahead.

Unidentified Analyst

taking for thanks is the question. Cecilia. for This Calvin on Hey,

of two Just of kind buckets questions.

First about I ask to AMDS want progress. off, trial the

So you've that thoughts wondering think you COVID-related period, kind had this then bit initial to on of enrollment about around month other in pressure if confidence driving And on sort in a spoke of trials you potential seen and nine prepared a follow-up. I your your awareness you how could just to more also within And your little a AMDS? as speak in enrolling your remarks.

J. Patrick Mackin

during the I the is maybe XXXX, Xa six good enrollment trial. one in And almost Yeah, think patients hit PROACT about so in we that COVID surrogate May after enrolled I we've of pandemic. mean, U.S. XXX weeks a started trial

track patient trial So enroll to X,XXX years in two under a we're pandemic. on

this should we've enroll our approved, think patient the the about ID first quarter. I we thing got second AMDS,

the personally visited night. Those The many patients. trial’s country. are typically all they them. is And XXX aortic in I centers These I do a patients centers. XX of have year. procedure. at this We know largest represent how medevacked centers in XX cases lifesaving a about the

Acute worries to A dissections. the least people's Type So COVID’s it comes of when

and quickly. feel this of contracting things. procedure, do and So they It kind of through time. getting the that we lifesaving centers technology, we're importance volume the the we the trial that there's IOBs the kind [ph] that pretty this of always But should nature and that enroll with given in the these takes this of

Unidentified Analyst

Very it. helpful. Got

on is sequential into One one just is I little margins. margin. second gross The dig a I to compression. two have the on wanted checks. bit

drive versus so in other between XQ, how reflected what's of think on and ’XX? Xa inflationary curious kind about that coming in R&D much. off cadence ramping So that just to, And AMDS XX? the your R&D And with ‘XX, what associated drivers, PROACT and back into spoke that thank pressures you would cadence in jumping then tissue you you also

J. Patrick Mackin

Yeah, so are you moving margins, many, combination of as a many parts. gross know,

clearly, increased costs inflationary it's labor baked pressures So the materials whether are or there. in from increased

or increased second more were a the than mentioned, a had thing our exposure had reductions. to obsolescence is The in volume we to we mix, field And product whether it's then kind rates. there's growth support staffed gross And devices. normal we which up given of did we've is seen the And obsolescence around, product and growth international just the line. see ‘XX, our return in of third, end the high of lower as to kind our cardiac you higher tissue, margin primarily

of So all it the beginning and the at And those things. R&D, then was a Oh, was mix can was one on you the that of year. inflationary clearly comment the Ashley? maybe of pressures unforecasted kind

D. Ashley Lee

Yeah.

So are rolling going lot We're getting going off up fourth the continues point million we're about PerClot quarter a R&D $X.X But we going some could this to submit year. ramp we R&D. have clearly starting of PROACT the to that be to efforts in at where in to money AMDS. be And invested also up. Xa We to to ended FDA.

have programs we roll. and are some to So PerClot might going

well. as up wrapped recently Just

said, depend it to that is the lot of programs. make that So will being $XX the with all with think R&D high low just be million on progress and in million, XXXX to that we the in we going the $XX a

Unidentified Analyst

Right, so thanks much.

Operator

Jeffrey is Cohen question Please with next go Ladenburg The Thalmann. Thank ahead. you. from

Jeffrey Cohen

how Hi, you? Ashley, are Pat,

J. Patrick Mackin

Jeff. Hey, Good.

Jeffrey Cohen

plans are under up? you you're Have stent had a and firstly, some bit checking, going forward? the source they [indiscernible] little caught aortic putting issues manufacturers throughput there? caught you're a about you And talk you What status So are the second and could pipeline, What's development. up? up the

J. Patrick Mackin

fourth in We grew the XX% quarter.

Jeffrey Cohen

on issues whatsoever? backlog no So

J. Patrick Mackin

which [ph] the on and not suppliers as you on issues We side new supply mentioned. we and is versus depending stent no up running. versus number But a we've We XX%. facility we a on almost put at, and grew we new grown which want built look grafts had up to XX% stents ‘XX selling brought ‘XX that we’ve

So…

Jeffrey Cohen

Fantastic. it. Got

you and on Okay, force little size you're the your comment could a how far channels for the bit Latin then and American distribution of direct that commercial as and tackling as versus arrangements? Asia

J. Patrick Mackin

kind Yeah, commented last Asia on expecting we've over XX% we're in Those both We're XX XX% out obviously, of and quarter. in Latin months about drivers. in probably and Pacific consistently the rates this those growth the see America. growth our I Asia so channels, bigger to Asia. we growth a talked in Latin And more, of this nice seeing geography. as performance of America one build growth saw markets we

half So staffed in of to fully there years, I adding then another, more. probably probably over there's And are need America. think next we you XX that don't the any up know, Latin we'll XX three and basically to be people,

So it's investment And returning nice really the now, we're they grow. regions rates. feeding growth that's also right actually an as

So itself next things adding started to people started with on. down. loosening investment slowed expect when we when flattening the then in But hit, of up, have out And we it probably XX months. back we that COVID kind

Jeffrey Cohen

half expect Is the further then perfect. that into nature one the segments time $XX or lastly, comment from million on first Ashley impacts QX. this and year? should for any we development a Okay, in And us, business integration

D. Ashley Lee

consideration Yeah, the the we milestones accounting out way fully every in fair the forward quarter and going and contingent value will is that's something are see the for future. earned until that Ascyrus paid

million for could that progress change, discount estimate factors, our a of But $X.X going that's variety on again, quarter. is right rate. now based a best So Ascyrus, forward, maybe per made,

but So of our there guess. things, are a best that's lot

the off. Endospan, option fully written For is

XX% will payment, So this to them them anticipate We have related that be milestone, enrollment reach trial. another other point any We million in $X million clinical some do hitting that. in year. and to an won't charge make And a reach $X see we expense. XX% whenever pay you charges that once their at they approximately they there obligation

Jeffrey Cohen

the That Perfect. for us. taking Thanks does questions. it for

J. Patrick Mackin

Jeff. Thanks

Operator

from next The go question you. is Thank and Company. Needham ahead. Matson Mike Please with

Mike Matson

for just the my thanks about questions. want ask taking I guess guidance. to I revenue Yeah,

So you impact some particularly the slowdown, XX%. around pro just basis, part And as I of guess? that helped in I of kind to fourth growth the [multiple guess currency the sustainable, there's really quarter was guess? follow-up I the expected, year. grew Maybe just a or…? forma early a But constant speakers] I that aren't that's one-offs in that you're XX%, on any understand why guiding to there COVID your

D. Ashley Lee

almost size Europe, Yeah, the for dropped That's last in and euro’s lot business million points think our have that's companies is seven I XX% and the the is of again that biggest $X in in issue one our Mike, this single common mean, of a and I of probably not a products are year. headwind. mostly the U.S.

the this it quarter, to ago a $X.XX, $X.XX. our are to euro it's the was mean, people straight and wrong I out of it's next taking and now kind if year QX So trying line number equation. math year,

a big to a chunk it headwind and business got we of euro, comes the So serious we when in have there. Europe,

the with So do it's to on a got headwind more -- or nothing to our is more think we're happen is currency. do backing with lot what to going off, -- we

J. Patrick Mackin

XXXX. against that other And of quarter the thing the XX.X% was the up were Mike, ’XX, XX% growth of fourth quarter too, we against fourth is

XX% if XXXX, comparison was is So X% versus and again, between we're XX.X%. it the guiding to

Mike Matson

All right. Yeah.

J. Patrick Mackin

Yeah.

$XXX.X drop, currency. X% new it's big to into the XX%. currency, catching the at people like the currency. saying our we're all think X% is the turns thing I revalue grow aren't to Because $XXX. going revenues if XXXX you It's We're

up just --I to can't not get got control I'm currency. going to You with -- set a

Mike Matson

you no, that. guys. Yeah, I compliment I understand

fine. that's So

sort first then, quarter $XX ranges right. like impact imply of the really ask All just hear looks or It like first you're would And to anything. consensus some didn't quarter expecting specific specifically. about math’s It my sounds ’XX, is million, so the revenue Okay. want growth right. versus if under any just which XX% COVID there. I

what high full too year on full for saying, probably the that’s range because mean, the that's you're the So your end at of high I year. based guidance.

J. Patrick Mackin

So million X% $XX that has of no impact currency. drop the in

patients currency. in think COVID the we're was And the I -- We mean, -- to hospitals with need given point at January hospital to checks first their any many these quarter. based The X% full staffing. they readjust So frankly hospitals, of clearly pandemic. -- is year in I lot we've procedures. as is They issue in elective on in an XX%. slow. giving were people XXXX reducing our had And January issue guidance the numbers a they did bigger as

we're out think I staffing drop, the empty seeing, news coming back. good is and hospitals cases

So of think definitely going than going but we be the is to don't rest QX to lighter the think we persist, it's year.

D. Ashley Lee

Yeah. Mike, this is Ashley.

point currency. you translates So changes $XX Pat's $XX year, we into And posted to account million revenue. about take $XX to million. talking that million Last if in I mean, FX the rates in

at. top to date indicated, our you base to take just $XX as at COVID’s -- the really XX% the is we in the that guidance that score. million. guided And XX% on that which of of should an least, had be really And you impact if that's X% looking is So at midpoint to, Pat

Mike Matson

think approval, And do that? lower if INR, get On-X quickly Mitral uptake Yeah, about I talked right. a on when that so opportunity. then goes, being, the think, it as I you've far as you the All you million, mean, I remember right, will how hopefully okay. be for $XX Understand. just

there? you how So can to get $XX million, guess quickly I

J. Patrick Mackin

It physicians. Number has with the to it you PROACT about already to Mitral We we product, think right. had on this. you've the sister has educate I one. on educated, already it's I already got mean, to did where same get -- and Yeah, INR right, aortic. for it because exact out. the to shelves. study, get aortic have The we've has -- the are we've a side, the news is two, lower the aortic, socialized great done the seen paper done we case It valves your have a great We -- number

mitral this valves probably in accounts XXX have country. We in

label’s So reps it's the change our all paper. and to market going are to going going happen, to the

our making So have which a and where that on products all happens doesn't what the far new product out shelf. as product getting and we of it like with as lot other exist that

to I over the Mitral, see did know, like you with aortic or four we steady increase in think On-X years. we're going So a next, the three

Mike Matson

Yeah.

All right. you. Okay. Thank

J. Patrick Mackin

Mike. Thanks,

Operator

Thank you.

is with Kalia Suraj Oppenheimer Please from Our go ahead. question and Company. next

Suraj Kalia

everyone safe Hey, Pat, is hope Ashley. healthy. and I

J. Patrick Mackin

Suraj. Hey,

D. Ashley Lee

Hey, Suraj.

Suraj Kalia

previous perspective, five reception Aortic Mitral, data? get guys' on my right? the And like, market has years, right, aortic. on the could the to On-X became On-X you piggyback if is love Pat, in I you math within pretty questioner, If leader been what the guys much

could, of $XX the say, million, $XX this if On-X in us you Mitral, Just $XX million, a map of million kind opportunity trajectory knowing U.S. let's is, that the

J. Patrick Mackin

no, point. of looking I think a Yeah, numbers. I'm I question. good Matson’s you're Mike the it's And mean, off dovetailing at On-X

you think if XX%. ‘XX On-X XX%’ grew ‘XX compared XX, easy, ’XX, So ‘XX, we we that's too versus to grew versus

little we So here we On-X, the every acquired got slowdown grown and the a And of pandemic, year basically double they five during years after for pandemic, years. indication. bit them, last the digits we the had given but five we've are after

it of five things out, changed. we -- to got a you've a get for and physicians, one Aortic. On-X look this got do guidelines last to a see kind new So did educate paper know your because well the I of have years from we tailwind you as think you've with the the gets And you just to

within a that think I coagulation. a represents, So valve different the brand

can So physicians, are mean, we've shown to the like market right. approval. do We that FDA approval, INR, feedback any valve. this Coumadin and I again I was in mitral product’s been with who's it get can't we of mitral valve get bit we position. done the we obviously, valve? wouldn't publication And the out you with Once shelves, present and the We've here a we've will adopted. get surgeons our educating FDA stuff And very the until lower getting little valve got that to really got I a if well aortic had to the why get steps The you're the the aortic want of patient a know excellent. We've protect that that, the research. has lot a less going mean data. on it's in we've the that the reps think now

it's it to but don't did. than uptake, all, do faster go I don't So technology you it's you get that, think aortic -- probably in I adoption one the going It's think year. get million $XX all Nobody right? and knows

Suraj Kalia

XXX PROACT I far, patients Pat so you guys enrolled if correctly. heard Xa,

J. Patrick Mackin

That's That's correct. right.

Suraj Kalia

anticipate finishing timing the to or Do enrollment QX pickup a you for to need in enrollment? you up do maintain

J. Patrick Mackin

Yeah, think add we centers. to I mean, I continue

centers got signed have we've XX this at on So we up, point. board XX

new impacted. patients coming see see busy hospital, think comes So enrollment, seen clinical to I things. a it's not do in And a we've of it. think massive probably And I When surge fair in think a that nice typically in. more are misstating other a -- centers center People you I we've five we like in. when say got get bolus in January, trials doing it's

think of the the but us we're I COVID It's these things on aggressive. patients running. putting help. matter investigator as a I having hospital, But and got just getting mean, now helpful and up it's with regular very in. -- kind we're We're that centers meetings, the the down down So calm of it we've should all front foot for

Suraj Kalia

hop and from Pat, And enough. back the queue. side, my I'll last question in Fair

average the And back, rep the you gap? What you you What I'm So junction, transformed let's characterize, Pat years, step current you? for And at how company. tell curious, there at average questions. the right? productivity, as you've my analysis as Take it obviously, you we does would seven you how do account? a see do per and optimal have Gentlemen, taking look revs gap fill that say, thank levels? been

J. Patrick Mackin

Yes, I depends thanks. it the region, think right. on Yeah,

of we launched Europe, with -- if on Endospan NEO. and NEXUS and the launched acquired thrown lot we at then We them, right. So at launched you new JOTEC, brought products we've E-nside, We've we've a brought we on AMDS.

we've like, whole got -- got they Europe, it's in pipeline. plot where a treasure of a So of kind the products

in, group for really got any got team they positioned I The But that. and U.S. extremely comparison, the haven't PROACT Mitral is of say of well as busy. they're a they've very come that that that new So would kind stuff.

a So that rep. it people add, businesses We add million positioned we've I don't street $XXX the in, add got you And the when that's these feet bring PROACT in to of new not the with and for don't they really you on they're XX a I reps, well necessarily well think comes, I've grasp. PROACT U.S. AMDS. kind positioned in any more of are got for They're been single one for the well a lot that products. when Mitral, revenue into U.S. lot In positioned need new more reps. Xa, can

significant these gross now, have out I of once investment direct see add to investment real accelerating well drop we and we’re sheer maybe just So maybe that's sauces countries and the we're our that through as mostly to don't as in we think one as of new growth spotty there accelerating the and Artivion flatten kind in Europe, we reps. Pacific go through all in and more of kind there is things line, distribution. through, drop come of we're direct to finish Asia going to our secret margin bottom products direct some in going here any And because

think lot about reps. a unique thing where can lot So cardiac you a of I a accounts of cover in surgery it's without particular,

any operator, more questions. Okay,

Operator

Mr. to at are the would for turn Mackin, no to further there this closing like questions floor over management comments. back I time.

J. Patrick Mackin

simplify of the And the some for us. our phase are a story we've to right? all, current We growth pretty one you is number today. first joining products, plan, initiative Well, time digestible is yeah. And significant with which thanks or appreciate one Okay, we showing spending growth. tried new to

platform or XX% XX% versus On-X this year ‘XX. grew Our versus ‘XX

and stents grafts or XXXX versus XX. Our stent versus grew XX% XX%

competitor, of Artivion. growth driving we're nice talking is any that So about growth the

our that's first So growth. in pillar our

second about Latin Asia growth The America. Pacific, regions. talked two rates the in We've is those

areas. those in invest to continue We

from through million got PerClot, then The talked we've then payment third Mitral revenue PMAs PROACT that first this two a $XX come which is we a and will sell us lot that And Baxter give them. should to which we PROACT year, about with in three the call. then PMAs. is way trial. Xa. fourth puzzle Expect the We're on XX% the the year. the of that this piece done of half of enrolling We're enrolling And

our And second AMDS. which approval in to expect enroll still NEXUS we're is device. with patient We pursuing the PERSEVERE, FDA first the trial,

we to forward great talked look a the to So story. got about looking I we're call. numbers on the and think And you we've next deliver updating

attending. for thanks So

Operator

you. This conference. Thank concludes today's

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

Artivion (AORT) 18 Feb 222021 Q4 Earnings call transcript