CRY - Earnings call transcript Q4 2020

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Operator

Greetings, and welcome to the CryoLife’s Fourth Quarter Year End 2020 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 is now my pleasure to introduce your host. the to turn Gilmartin Lewis now Group. will call Lynn over from I you. Thank Ms. begin. Lewis, you may

Lynn Lewis

Thank and Good you. afternoon call joining today. the thank you for

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

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

concerning SEC Additional earlier turn company’s forward-looking time the in certain impact With the issued over release I’ll call to CEO, CryoLife’s today. to Mackin. time that contained these that, that statements press was is may and the from information Pat in filings and uncertainties risks

Pat Mackin

Lynn, everyone. Thanks, and Thanks afternoon, good for joining.

continued business So was of very impact our the of COVID-XX, nature despite products. resilient given our the

and products including business, our launch R&D, and in to expansions. invest manufacturing trials continue site innovative We clinical

and year and will by outlook. on first a strategic the we to XXXX. year. full closing performance normalcy touch XXXX then well in fourth the to results, of to look Today, remarks provide and we second providing further later our for highlights potential in before questions. as to initial call XXXX in as I open updates see the the on followed expect as more return hope details quarter as initiatives Ashley several XXXX, commercial especially and Europe the become financial products the well to We our QX of expectations reviews upon the realized, As XXXX, our start full of make then we’ll our fully U.S. will half your

quarter As call, optimisms lessened. growth we related October have generated as with the we as in fourth discussed on headwinds revenue XXXX appeared year-over-year September we of ended last and our COVID-XX to

However, since and lowering procedural across slowing world, around return growth. the November, to pandemic worsened volumes the again our geographies

the as long impact have that in lessen Fortunately, are pandemic. procedural well this of throughout all, adept the used because procedures of our at or hospitals was critical at as and business continuity for managing postponed be on products resurgence increasingly providers our most cannot become

coupled appears these This had continue was should XXXX see last in return we and to of procedure test as to from again year-end or advance returning we said I CryoLife volumes XXXX second growth near performance and the infection normalize to spike. maintain like quarter. acceleration rates to XXXX, R&D to fourth the that in investments But vaccination once both companies production in the that and many other year. relative capacity. and before, So caused us headwinds, It the the despite solid declining now believe are with mid-year we our initiatives at half put XXXX.

both In field and addition, our supported procedures, teams virtually. in-person

and times. service for challenging these creative outstanding performance entire thank at deploying particularly team their was solutions patient our ensure we care. adept organization And to Our continued customer during

in forma on basis. TMR the a million, decrease XXXX of constant which in X% in Still we October, constant forma pro reflected year-over-year quarter Turning XXXX. compared a on XXXX revenues, November exclude of December X% and December see basis impacted we and revenues do to decrease and decreased revenues fourth When to spike to recent in the X% XXXX December growth revenues currency cases. of QX procedure a a total to our pro of in basis. volumes decreased a returned fourth GAAP continue quarter quarter total XXXX versus $XX.X procedures fourth most a X% results, currency of on by declined achieved you being Volumes and volume

first that has in be – COVID-XX XXXX year-over-year unpredictable, we the saw to XXXX. performance Although been the of in will the our quarter we revenue of COVID-XX similar anticipate impact COVID-XX what on of the fourth quarter

in well Growth by XXXX be as of of into But the and rates in in a into QX acceleration X% that the growth these JOTEC experience next on Taking of and when will tissues between to optimistic initially year. factors We to quarter regulatory will occur, back return exactly we for growth of fueled half AMDS the Ashley X% quarter full impact of be quarter do We as on expansion shortage down year launched however which temporary our positive recently also XXXX later. XXXX. be Due the news we revenues QX guidance will expand of to second as normalization we Latin on products, to as and the COVID-XX from in NEXUS, issuing we the business. significant QX predominantly front. compared growth to remain anticipate Asia-Pacific expect to America, the and relative not XXXX. of well account, uncertainty saw last generation on of continued will our XXXX, our in prospect XXXX second expect the of significant

acute dissection Looking outlook specifically for treatment encouraged. A arch the world’s at remodeling for device AMDS, the remain hybrid of the first using type

of fourth increase compared a basis. currency in $XXX,XXX of the constant quarter to million XXXX, quarter, of fourth the an During on $X.X XX% posted revenues we

still the technology. being by restrictions and more in impacted cases beginning our travel scheduled are Regarding to the and optimistic in launch regarding future we this for our is as But Europe. NEXUS, lockdowns, COVID-XX for near effect remain currently prospects disruptive see

the feedback the versus even surgeons headwinds. resurgent prior from COVID-XX our XX% We positive on very fourth the growth quarter valve. get year, face aortic to of in continue also On-X We in the saw

that As X. X reduction heart reminder, our run INR only must specifically, an to INR competitors from the demonstrated thromboembolic reduction INR had run valve X. compared of in Whereas aortic a valves standard mechanical dramatic our levels mechanical to can with levels, valve increased at is approved XX% other a of trial risk INR the lower all at PROACT X.X More On-X the events. bleeding aortic the to of in FDA no

update Turning operations, good we news more report. have to to an on

manufacturing across supply without As been we’ve remained run three indicated, facilities our any has few at or intact. near and capacity our with able chain to disruptions,

supplier European the and to us. body source currently our sewing was recently addition, is In by approved second notified product supplying

XX Feedback which patients trial, on have a We’re been trial prospective enrolling if Eliquis maintained patients begin currently We our enrollment. safely the surgeons from very participating pleased qualified participating are sites in clinical patients of currently warfarin. can the in fully actively have over On-X on study. randomized with enthusiastic. versus also XX very the sites, has to to and with the and PROACT XXX the determine and enrollment be we aortic trial effectively progress is Xa valves

FDA in position Endospan recently NEXUS. clinical we’re first in secondary this a delayed are to strategically commercial to the enrolled patient two front, activities of now, and filing evaluate in for some trial the its positive now highlight operational regulatory like but arm PMA primary a with its technology. patients XXXX. of our goals arm U.S. the I’d key and the to file in a we options our PerClot On – for for

feedback will we generation are release in to in received E-nside full good continue release. First, with and next move rollout the on those of now market forward our XXXX both NEO E-vita limited OPEN from our physicians products. and during We JOTEC products market

during expect of procedure However, But to during volumes XXXX. momentum do hampered being the currently the as these in gains technologists vaccine role the to of impact volumes But we do the improve rollout by expect Europe. still procedure we XXXX not is pandemic. improve

market feedback release by limited received net prior market mid-XXXX, a we in E-nya, and release our the in followed during some our incorporating later year. limited feedback full market to release the continuing Regarding customer

In the slowdown our The resulting manufacturing will these our source second launches inventory improved efforts. from JOTEC with and internal business by market pandemic, addition, be full COVID-XX supplier. associated backed own

on call, to our up earnings more gearing are these As support last train I also launches. teams to our and mentioned more physicians

pandemic significant through age on have leader headwinds by endpoints, all the enrolled. make the these still On-X successfully progress in of we our valve become trial. enrollment By we can the achieve patients and XXXX trial to XX% XXXX, under expect in of such the market XX. Xa valve expect should Despite aortic we XXXX. we assuming trials late its we market and FDA in at qualified share believe approval, least we PROACT XX Second, to year-end, believe meet approval obtained aortic If early sites

the I answering trial, an on trial, questions. aspects to watch Co-Chair the PROACT webcast well of of it. excellent Alexander, PROACT For the John December investors’ providing of those Xa the key of job you comprehensive did Xth, encourage missed overview a as Dr. as you

You website. our can find it archived on

the key PerClot initiative the FDA third Our third XXXX in PMA quarter. file with the is during to

PerClot ready currently small-scale PMA open manufacturing. submit surgery are the application to We for and

to be the manufacturing also commercial large we indication believe partners, attractive capabilities. However, potential to laparoscopic in we need

Coumadin, recently approval implanted mitral a in be valve. to include to which believe in On-X timing regarding currently we PMA additional our factors mitral we’ve mitral As to lower enable submission what in valves. similar submit expect BioGlue share approval the on now patients valve submission, our maintained with file QX. regarding patients Fourth, for to in us the Fifth, aortic we PMA valve result, such label a will take compared On-X to for have mitral plan changed the aortic the significant of the other the these the approved, we’ve from We with the is On-X label valve. additional China, market BioGlue. an in FDA with If on low valve. mechanical of On-X Chinese valve dose we our for This for mechanical for market approval mid-XXXX new questions the received could labels we seen regulatory the to INR to a our similar

And approval trial manage revenue us PMA to growth we growth. clinical a work to once better our risk, to accelerated believe we in necessary XXXX, in position by forward in and We you for an operational timeline, and to and update are complete expected our later IDE year. mid-XXXX, receive for we testing all may currently our in the expect evaluating what impact with to questions to expenses AMDS, to position begin putting the strategically IDE have invest receive are these pandemic a the by the XXXX. Overall, mitigate Throughout look providing we file on timing deliver lastly, approval, year-end continue on to approval also subsides.

turn Before to manufacturing and more pieces. I report. we I one it our are now change, of cleared from TMR received to good resume FDA that piece to is the news We hand have suppliers over Ashley, our of award sale the approved site

We’re up in and gradual quarter. a the of have will to we the beginning resume process TMR supplier in anticipate second with production our working that ramp of

more we a We don’t commentary this I’ll TMR anticipate in re-launching the will turn year. but on quarters, up future over of now have to ramp Ashley. With QX call that, until

Ashley Lee

tissues the compared revenues, good shortage in of our Thanks, primarily COVID-XX, as $XX.X were down absence from I TMR business the shortly. certain X% to due temporary on company Pat as QX the detail afternoon, revenues XXXX more of to well fourth will million everyone. discuss and Total the quarter, that for impact

in revenues the year On decreased and quarter compared of increased on of to fourth X% business tissue XX%. revenues full the decreased X%, were increased full X%, impact a revenues the BioGlue On-X from $XXX.X X%, million, to our to XXXX COVID-XX. the processing year, XXXX, basis, down primarily JOTEC due revenues year-over-year For revenues

EMEA decreased decreased decreased decreased compared primarily On decreased fourth year pandemic. full North quarter regional XXXX. On-X fourth America the and all was revenues revenues X%, by X%, Latin XXXX revenues tissue XX%, revenues X%, X%, XXXX full North Performance to decreased the in Asia JOTEC Latin basis, adversely XXXX COVID-XX these revenues of and compared X%, in decreased year revenues, each BioGlue and X%, For decreased decreased X%, the America affected decreased to to full America quarter increased in XX%. EMEA Pacific XX%, decreased X%. Asia X%, in processing year revenues a lines America XXXX, Compared Pacific of product

Our the XX% quarter gross the quarter fourth XXXX. of for for margins were fourth XX% to compared

business interest for – due of full Ascyrus, approximately a later million margins the provide to million of XXXX. benefit $XXX.X $XXX in million, in compared tissue benefit to million million gross XXXX The XXXX, during $X.X related $X.X In translation fair other Endospan, were million quarter to to convertible million the stock million PTO unrelated to to gains. unrealized pretax For related valuation income year related year certain approximately Fourth value approximately $X.X met debt Term reflects of targets a our $X.X fourth in in inventory cost. XXXX. expense $X.X Term million policy, cost. and quarter related $XX.X partially XXXX, charge of debt more origination million of and in other realized million expense offset fourth of and translation Fourth in partially XXXX corporate XXXX. change of our fourth contingent development foreign million $X.X million, consideration resulting assets. year by In the quarter origination my full non-cash B, financial amortization charges on quarter adjustment related tax of compensation, of XX%. includes B, of expense margins primarily expense and $XXX,XXX in remarks. of G&A Tax debt full $X.X Loan includes from $X expense value years $XX.X not currency our pretext expense reversal $X.X expense of Full of in in quarter year acquisition to to interest deferred quarter because of G&A currency the expense and $X.X XXXX, includes and in million in of $XX.X million the of that were and realized for debt convertible performance-based $X.X inventory detail full adjustments were million, interest of to offset to a $X.X XXXX the related and full approximately the the of expenses for a includes $X.X million year include our our a XXXX to interest includes of by non-cash year gains. amortization unrealized fair fourth million and were and of gross quarter foreign full expenses XXXX fourth allowances approximately compared million the $XX.X Loan the I’ll

$XX.X approximately or of fully fourth million $X.X line, in share. approximately $X.XX $X.X the in Reconciliations GAAP net of we in per the of reported or income year share full XXXX, and bottom $X.XX loss afternoon. the On the this income loss to non-GAAP million press of or net $X.XX was fully quarter of income GAAP net Non-GAAP EPS per quarter. or $X.XX we for full per per share we share GAAP issued net million million Non-GAAP release diluted XXXX. diluted fourth reported the $X.X In the year. included are that was

quarter million, XXXX. compared of As of $XX.X the fourth XXXX, million of for quarter Adjusted debt. million was $XXX XXXX to had for December EBITDA fourth approximately the XX, in we $XX.X

that the expect COVID-XX expectation QX do and QX full performance, believe will $XX.X that COVID our year, compared COVID our we’re return said, quarters. last February domestically approximately growth headwinds be quarter we cash potentially expect once X% of tissues The lot first $XX QX tissue a with information release as mentioned that XXXX a confident see revenues was of is that equivalents, our of to likely to XXXX decrease non-GAAP in a double-digit lot. contain the most for a in-house solution of temporary QX quarter and We to the XXXX, causing trends contamination the quarter X, solution to identified will the and we later our Pat uncertainties to reconciliation adversely solution of to supplier in of are recently growth have commercial credit in products, about quarter, COVID-XX XXXX resulting then in impacted tissue – refer to year. the results, that facility. estimated not contamination in currently the to approximate results. our to of this million million impact a As financial from fourth small to use we compared QX revolving COVID-XX, outlook to in bottles COVID this will of especially of processing as the to year well regarding for subside, continue $XXX,XXX. these launched. press us an due compared by realize Please available at the X% time. the quality that do and the we in improve. fourth potential to impact COVID-XX. the to our lot, affected impact including processed us see XXXX, GAAP to write-off on unrelated poised true those of guidance issuing cash during contaminated full the a availability, due tissue as of continued additional is discovered saline under had COVID. internationally, of shipped that number of if now, QX percentage of that tissues QX we And solution a in controls. earlier, amount top-line XXXX of small our QX in those results by shortfall we the our availability to We with

our of the the flow related used generated to and contingent our the can the payments regarding to expense non-cash periodic primary million for $X value third time, through release this assumptions likely this will be We can we be passage These contingent have expense. acquisition of for require release a obligations. cannot for in to then their expenses beyond. our the by in if regarding tissue made reassessed. discount obligations other a take processing as under instalment will additional and this midyear. upon $X through have as million. activities tissue, within will periodically for tissue, of in and extent further consideration Endospan’s revenues recorded charge accounting of changes quarter. QX value tissues may interim, factors value to calculations. of will the likely this rates impact and this increased the final charges XXXX, XXXX. a approximately in be for of critical contingent enrollment There the fair lesser value as tissue to fair evaluate first fair driving we our milestone with mitigate there present contingent processed in release. will earnings we NEXUS, note clinical in tailwind we for year. Endospan, associated processing agreement, these Accounting and the business be Ascyrus that make conducting achievement U.S. believe Ascyrus a adversely flow distribution. non-GAAP can we and released of XX% determine we an expenses we regulations If related items result, review tissue demand arm that If to on may occur after review remaining other couple until our to which may will affected anticipate lot be business their We contingent with take transaction will of trial charges of that procurement are classified to consideration our Endospan currently be solution are SG&A consideration to meet tissue development temporarily loan fair business at our late In we our for and value

the million XXXX. million expense. for AMDS, million in U.S. Ascyrus, $XX a related We occur IDE XXXX. of payment former AMDS in make receive the to The expect when second occur late to million to $XX could second, $X.X we cash. IDE and consisting record payment of other trial milestone we in will the of in and a this in half late of approval could approval payment This $XX stock shareholders approximately clinical begin

additional XXXX, which and We net is earnings. net instruments. debt $X $XXX on The simplified an the The will value by million will the our adopted quarterly with accounting to to is decrease income also first notional XXXX. up effect balance beginning tax its convertible approximately approximately XXXX-XX of million non-cash quarter X, we fourth statement on retained debt $XXX,XXX in convertible interest ASC of on compared million $XX that liabilities for our by early as from offset paid-in deferred the of capital XXXX, that million reclassifying the from of sheet January impact $X.X expense to quarter gross

commencing our We in Overall, JOTEC additional and anticipate primarily to product AMDS we greater the million of refer channels JOTEC products. CapEx line, without the last ongoing developed in On-X as expected agreement our accurate to increased to service over we able capital. stent $XX will investments will in and million our to to expect these to our our the to our former through is XXXX and Our investments in line XXXX plus relates and having description stents AMDS of as leverage. comfortably line commercial these One which particularly and XX-K more see fund or a invest not reports will increase intend investments distribution include of but nomenclature we demand our these R&D item do generation periodic due pipeline. to anticipate investments expansions will make we channels, products. both and in and plateaus XXXX, and leverage ongoing filing years. likely the $XX meet operating be year America, continue the to and next for believe the that our our seeing can in debt product manufacturing JOTEC designed operating increase our Germany we our recent addition operations aortic that are pipeline significant R&D and We growth, regarding grafts, lines, This that cash well increase with is for couple than our to to raise the two, Pacific we fuel and NEXUS, XXXX. to then NEXUS. as to we Austin to Latin over believe of in as product begin with regarding spending next anticipated our our Asia meaningful our in a in

Additionally, XXXX item. our our future beginning reports, will in we report processing tissue and as single-line public and revenues a filings

We aortic grafts, will then four primary tissue have BioGlue stents which and is categories, sealants, stent surgical product processing, and On-X.

We will also that include begin TMR category to include PerClot, another will PhotoFix. and

changes call We’re years of on the I the few multiple reporting simplify developed or have over turn closing for over products past company’s repositioned acquired aortic we that will Pat comments. his making these to the the to we’ve repair. back the as focus

Pat Mackin

Thanks, Ashley.

double-digit of this despite in global the year-over-year. past position well. new XXXX. pandemic, improve growth believe to middle improve as pandemic XXXX. rollout though E-nya, will and chain. by levels, have all formal products; world we perform we our are very return accelerate. we of business procedure three guidance, We and So work realize when not benefit full-year XXXX, and in the E-nside potential in done the are we launch E-vita that available, more the the heard JOTEC a will fully begin as growth from that continues their will to the as not volumes have first the even to widely we of that be should see we deliver in do over market catalysts we hopeful revenue improved five conditions conditions you’ve XXXX subsides vaccines afternoon, years and closing, to several OPEN the well be vaccines a previous we market around believe we’ve did our as supply to various our in in XXXX full position the providing NEO,

the launch, Second, NEXUS both growth unanticipated and XXXX, and should product absent AMDS in impact. COVID-XX are we addition in in full of see lines, nice already

PerClot On-X we have PMAs and China our our to XXXX, filing our news both mitral for Third we and submission. are valve, in for good BioGlue hope

seeing our and investments channels anticipate we Pacific in our XXXX, in from Finally, upside America. further Latin Asia in

financial heightened of give our catalysts increased us these drive to performance. All optimism ability in

summary, and forward our the on the portfolio our is in once day about of of the strategy products. repair. innovative effectiveness to potential demonstrated we to our confident So remain when focus the the behind growth resilience fourth product aortic We us, again, of and quarter, COVID-XX look

expect continue I outlined that, up the like with Lastly, to now to solid by open operator, goals to the operation funded us proceed. on earlier position. I’d questions. our please financial line

Operator

Thank first go ahead, Kalia, question Please from and Oppenheimer Suraj company. you. The [Operator Instructions] is sir.

Suraj Kalia

Pat, me can Good afternoon, hear everyone. you right. all

Pat Mackin

Yes, hearing we’re fine.

Suraj Kalia

Perfect.

So Pat, ending have just well. Ashley, did a tough guys you year? And the a you if congrats on reasonably what otherwise at was look numbers,

it a to JOTEC category me Ashley let to downtick or X% X%. Pat, is with specific broad-based that. grief out or X% is on whether the or causing some services from it’s level congrats with, is start So, maybe the maybe, the or out that start guidance, On-X year-over-year X% the of QX

Pat Mackin

Yes.

to add chime Ashley and can this anything. wants take in I’ll So, if he

So as QX quarter. you know, year a the really non-COVID last of was first is, thing

normal had we’re a we still issue seeing post still QX then other ones and for is one still early issue you it’s – from you the we is it’s – pandemic XXXX that’s really sell two, the first around. real hanging comp. because in commented the And us, are where our that tissues caught. we we issue in only quarter, supplier goodness. to impact that quality a the on spike into, process a it’s So, this number going the QX. tissue ran so the Thank we biggest XXXX, COVID that

frankly, that’s that the biggest So reason.

must I’m I Now, say that encouraged.

currency we’re and quarter forma constant pro the through halfway We’re like down X%.

through feel halfway we’re well kind short-term being than we’re actually of of quarter, this, what far we tissue but So, better shape than impact. cautious, so as COVID just the we because in this thought. doing we’re like as better

Suraj Kalia

it. on at file if data ACC? maybe INR On-X low we mitral, pat, to Got with the should midyear, you’re expect presentation approval going for regulatory

Pat Mackin

meeting was – actually Yes. a in in we’re I on yesterday. fact, this

want we to we presented. want where We’re and get actually this have to where it about, talking published

So, a through. go process we that’s that obviously

don’t you like more to – the should we in we to as go we the have but PMA get have – go two, next will update So, probably quarter August. in filing, this because the on, or color in closer anything in PMA will

So, we to our on published. an able should QX we update on I to you maybe, where would call, that think give expect be be

Suraj Kalia

Perfect. is PROACT XX Pat, on what? now, equal is date December to Xa, Xth N to equal N to presentation

Pat Mackin

XXX.

Suraj Kalia

nice. so you doubled. guys Oh, Oh, have

Ashley up split. Maybe, and year-over-year. specifically, Pat was XX% okay. it Okay. On-X was I maybe I heard a missed this. geographic

me, frantically number notes. a and making in I was terms of was that Forgive What OUS? U.S. specifically

Pat Mackin

Yes.

you So at can look number actually that for total the quarter. the maybe,

So, in number presentation growing the in XX% – as U.S. QX well up was comments in QX over highlighted the that XXXX, we’re was face my my pandemic, I a of On-X even that XXXX business in XX%.

So...

Ashley Lee

aortic yes. the was valves. And that

Pat Mackin

Yes.

Ashley Lee

Yes.

Suraj Kalia

right. All

Ashley Lee

the And was On-X so up worldwide. X% for quarter,

Pat Mackin

So, the our market, got was aortic. U.S. plus look in mitral. full the aortic biggest which up is U.S., that’s XX% X%, and but worldwide was On-X you When the at

Suraj Kalia

was side, That it it. quarter. Got gentlemen. my Excellent from Yes. Congrats.

Pat Mackin

Suraj. Thanks,

Operator

is sir. from Matson, Company. and Mike The Needham next question ahead, Please go

Mike Matson

now really in to guess, first X% to go just after a sounds that quarter for down I it like you’re you’re far. then I’m Thanks. to the X% downed said commentary your response confused X%. Suraj’s to X% saying the only back so you prior question, little want guidance I and to Yes. down X%, because

tissue or to and hit kind the quarter down something, really the of hasn’t hit X% So is in been going later in that’s because that that or…?

Pat Mackin

Yes.

noticed I disconnect little two bit bit a little So – Mike, things, there. of there’s a

QX, going been down QX, all we know, super got constant were you we hit unpredictable throughout So we then wave. X% into has the And was second currency. this encouraged – look at you pro as by just as year. heard, the pandemic while forma

We that an Suraj so that added still have frankly which to pandemic next issue, around QX And shows tissue all quarter got quarter. the tissue made supply process we predict. the hard we’ve we a up in this short-term to – and I comment added the is hanging in have the

out. hard be to it’s much to exactly that figure trying So figure out is how tissue of impacted, going to

for in down that was down COVID. and through to we’re number QX very down then surprised put I’m left halfway a issue. were us, we hadn’t due X%. the few quarter – X%, tissue so X% we thinking the COVID December the So pleasantly points

it’s yes, with next exactly – to looks happens in weeks, far I it hard tissue being obviously but cautious So, predict the so what we’re six think it’s because good.

Mike Matson

Okay. wanted then I just And of Thanks. ask potential to the procedures. backlog about

imply you and things probably comments the the are long. your used as type as don’t they’re of maybe surgeries companies sort of that really that backlog products? the can’t that you that in Would type of a typically elective made deferred products did be Given and big provide have that nature of then that more that

Pat Mackin

kind Mike. I’ve had I restrictions cases a travel month is of big from a are growth in canceled out We’ve and in and lots the U.S. what? Europe. move COVID. what remember, hard we’ve in coming with Europe, You And business there’s a in been because U.S. think they and to know pronounced difference I’m more Europe between big The are hearing of a bunch lockdowns say, It’s of hearing the lot of the last in way in than curfews the customers Europe. the and got the and our I’m what of

to into an cases. our a products So kind ongoing it’s drag of to just on ability launch get

them I here last next it’s said they a hospital at there on our are mean, Wednesday, and was ICUs no ago. think I two up. the center think operate, and So I called spiked issues. more another the week, I you was that. and major in of weeks big And in they day, can’t U.S., said, administration I just guys said,

I road valve hospitals acute type repair, a you of kind valve had better. hey, bit. you be manage have the me, another at or said, of have you to have telling you, a can’t learned down urgent surgeon kind if major may center that. where we their stuff that if they He also are the A delay a an don’t – there heart great, a mitral I’ll guarantee you clearly dissection, whether urgent need aortic for feel people but it’s an pushing So little know who an fact,

pistons bunch all data but I’m – points say you we from giving that a it’s given So running procedure to not I’ve with standpoint hard are of the clearly of pandemic. exactly, a because

Mike Matson

to on helpful. I one That’s And wanted ask PerClot. Thanks. then Okay.

So get do anything that understand to what guess, manufacturing this to the comments labeling? just of didn’t delay indication, do part on the guess so around this that. waiting have And laparoscopic of type you’re if I I you that other then I

Pat Mackin

Yes.

this see easy me let to understand. will because be So

been was what were was assumption PerClot Our with surgery file the our U.S. potential want which they CryoLife’s under small not would laparoscopic, the call which we CryoLife volume. And a be is. where to with and in that original would to of needed is huge a and channel this that product that for file we launch. scale more big plan going manufacturing, open want all In have lot to distributing I the partners, product fine And they is for chunk discussions

to do to then larger just smaller with kind or an of said, got a filing why have go more scale – we don’t a up technical I larger enough of we’ve testing a do so and the couple instead product, product it’s and stuff, we to to validations it. the of simple indication not So, indication we make get for wait say to study. mean, can just laparoscopic capabilities And way a basically quarters, a to animal is we lesser some

bigger will the done a by more. to which in all market with be we’ll produce PMA that’ll and submit the us access summer So give a this to QX, ability lot

Mike Matson

or a or…? distributing there, from partner sounds it partners it given Okay. a when potential Would be interest And amount there’s single this decent partners like multiple just of comment likely product. your

Pat Mackin

get I and I’m Yes, just potential products. get supply us access into going the that from wanted I’m they into not level have as going detail. to a feedback – to partners, of bigger to for as not to more got market we ability checked we that. again, –

that. leave I’ll at it just So,

Mike Matson

Thanks. understand. Okay,

Operator

Jeffrey Ladenburg is question next Cohen, The from Thalmann.

Jeffrey Cohen

Hey, Pat and Ashley, how are you?

Pat Mackin

Hey, good. Hey, Jeff.

Jeffrey Cohen

from So, bunch Mike I me, think just of a caught Suraj and them. few a questions

other. far specific the like as as was So, or that specify a you Because doesn’t it issue, vascular? with cardiac to tissue look the

Pat Mackin

both. was It

Jeffrey Cohen

It was both.

of ramifications $X as and there And Okay, as your some your there million charge it. as your potential got forward? carrying insurance from – what far are as supplier the going you’re any far

Pat Mackin

going not Yes. that get detail, to I’m Jeff. of level into

Jeffrey Cohen

okay. Got it,

can bundled know you an give for us QX? in indication forward? under you’ve So, now where all path it AMDS one fell I out

Pat Mackin

Yes. which out XXXX, million XX% increase. in we $X.X QX versus of is called QX AMDS it a did

Jeffrey Cohen

fantastic. That’s

Pat Mackin

of Poland to the was the inning aren’t mark, We we QX. it we over regulatory. get We get had CE – some need the lap the Spain, game, access the even paperwork to of but do to the race baseball to have just to came in And first in first fourth late to quarter. because didn’t kind the in late had paperwork of special some Italy, we to that do

really even isn’t that yet. So our numbers in

also countries approvals get in America. Latin We and to and are in starting some Asia

Latin and growth to this in we’re in and Asia, of throughout all Canada market, the all nice Europe, So, year with access markets in markets area. expecting of that American all more the then

Jeffrey Cohen

Got it.

called a you about aortic the Was quarter? out slightly there for previously smaller On-X that talked the had you in size any for update setting. there So,

Pat Mackin

have millimeter pretty just in that. that. back XX just pediatrics from with No. a I to it’s I a on or because patients, that’s offline standpoint, for it’s such the It’s clinical here the, data trials there’s just a patient enroll of been close to trial there, finishing We’ve we’re and but to a can either awhile. got hard you a valve rare don’t – get good chunk

We’re pretty close that. to finishing

Jeffrey Cohen

got know any and sources issues the on of as Okay. commentary currently? some no you is full-blown as demand up that the product further, Texas both the safe far there goes, it on and longer, guest running for a there, update JOTEC it any line. I source called second And out Is is any you��ve now;

Pat Mackin

So I was XXXX grew We you I but challenge supply a mean, – coming was a off think, grew double guys all was still digits. XX%. it as year. JOTEC and know, the we

at big procedure is the to run in really slowdown. our the So, factory We’ve Number XXX%. took pandemic us for a three JOTEC with XXXX. causing done supply opportunity We one headwind the things. the was

the So, we inventory during pandemic. built

So and to up our building expense. is that’s helped. two, a running. Number by sewing source, big in facility going product. our in talked capacity new Hechingen, increase They’re get did number we Ashley increase supplier about built the And supplying three, us We’ve second in already capital XX%. which our

these product new to supply not a combination the constraint. we’re not So, be things products, with of is – going those three

Jeffrey Cohen

perfect. Okay,

that those taking are I Thanks me. think questions. the from for

Pat Mackin

Thanks, Jeff.

Jeffrey Cohen

Yes.

Operator

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

Pat Mackin

that the mean, in We vaccines Yes. little Well, the is the we’re in bit thanks what’s reason the obviously, E-nya normalcy XXXX XX going and Asia we’re the is like launch, have NEO our think we’ve to the in plan. The the we with investment NEXUS, the for joining so E-nside attention launch, in U.S. things got who’s launch, and I to rollout didn’t AMDS vaccine and We’ve in Europe, QX. company. pandemic aware PROACT think for XXXX. Pacific for BioGlue America, a a got for and we’ve return potential year the the and we’re a excited on Mitral. everybody’s enrolling filing going We’ve in the got China two and to this appreciate on PMAs approval. QX of pandemic. behind Xa Latin comes – We PerClot PROACT with got

we going company’s the well delivering pandemic this obviously, start like positioned double-digit a on, So to growth. a got as lot we’re but lifts, feel

call So, forward appreciate your the attention quarter next on and look to the update.

Operator

This concludes today’s call. conference

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

Artivion (AORT) 12 Feb 212020 Q4 Earnings call transcript