VCEL - Earnings call transcript Q2 2021

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Vericel's Second Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. I would also like to remind you that this call is being recorded for replay. I will now turn the conference over to Eric Burns, Vericel's Head of Financial Planning and Analysis and Investor Relations.

Eric Burns

good and operator, you, morning, everyone. Thank Vericel's our financial to second quarter discuss to call conference results XXXX Welcome and highlights. business

are the will begin, Act Reform we statements with today's covered our from let remind the be that we under you statements in making are and and Securities which filings of involve XXXX. materially to Before website. could differ Private described forward-looking cause risks fully that results available SEC, me may more on call, Litigation on uncertainties These expectations actual our

financial as forward-looking today upon in available In represent as Please our addition, all Relations results statements Investor our the quarter a representing should our of of relied press views be release that our only subsequent website. date. of note of is not any section views and copy as second

with this short Officer, or the today's have Nick on joined Joe our presentation call that also our will turn on over and President Mara. Colangelo on the accessed highlights We directly Nick. and to be now Financial webcast Executive Chief Chief can call Vericel's from Officer, by being viewed I'm I a call website.

Nick Colangelo

XX% everyone. of in Thank and financial we good second continued increase and of morning, an XXXX, quarter, XX% XXXX. extremely to reported results. we the quarter From the well $XX.X revenue total commercial company and you, second to another for perspective, the of quarter execute million quarter of the compared second compared Eric, to as quarter strong second The delivered of a financial

half provide we're guidance both $XXX monthly guidance drivers key From details guidance we million, with a adjusted regarding MACI continued same perspective, and quarter. updated the fourth deliver growth financial in the cash strong highs than operating year million to to MACI achieved XX% to XXXX, will quarter. a flow grew to total XXXX biopsies, in Based the our further margin moments. revenue We second in the to underlying which also and the generated and full EBITDA respect EBITDA compared XX% on for more Joe results results, these our positive of XX%. first XXXX consecutive few $XXX quarterly to period record and Epicel. commercial raising adjusted to for in

We also had strong high with the our taking performances legacy biopsies in a and across both record territories. of number quarterly expansion MACI surgeons

to of the the biopsy force in of in year. drive addressable biopsies MACI taking years believe a growth strong us we're Importantly, overall expansion meet terms our by number into to surgeon virtual efforts only business new the MACI that resulting MACI on well as of the growing reflects from and than country for driver, marketing target XX% person added XXXX led positions the highly year. effective which our surgeon of surgeons continue surgeons Based of is our expanded territories in engagement of positioned strength growth market. to and sustainable the strong half and the for first new We the primary this year growth the more well the but this sales in biopsy biopsy programs, the penetration fundamentals, ahead, underlying not the surgeons, as

to Turning care our franchise. burn

ultimately, of and increase patient sales centers leadership volume. burn customer and sales in the in million, generating level revenue Epicel the the recent in roles biopsies driven substantial record increase customer-facing we the Epicel to of to clinical number the and support have base, center in utilization our We quarter. grafting also second changes $XX.X of the highs quarterly our Epicel burn higher the number at believe Epicel Epicel that in the patients of addition In achieved record quarterly

also has patient per estimated grafts Epicel in addressable an Epicel. or led increase increase for in total TAM our to significant market the Importantly,

growth was ago The call presentation, described Epicel to believe years positioned actual of XXXX, trends the than over developed total the earnings for first graft the have year, million. this based TAM utilization $XXX penetration addressable more to moving Epicel was increased of we're Based into the per Slide time. half TAM sustained previous past strong million our results of several $XXX more strong Our well driving market on historical our and on continue X on increased as we used than that grafts in in number Epicel patient forward. and at Epicel accompanying that

by noting I'll NexoBrid. points. Turning a important few begin to

care outperformance this expect initial for year, we Epicel's on will even launch. XXXX for based NexoBrid this franchise now significantly year, delayed the revenue with expectations burn First, revenue our that our exceed

experience met MediWound with clinical primary believe awareness through approval. study, to to the results resubmission III And the NEXT leverage Phase all NexoBrid the top lead process of also the finally, we drive the profile continued upon time that recently product. NexoBrid MediWound which NexoBrid. disease for endpoints to results, the for with strong and uptake its We in reported with on protocol field force with their position the reinforcing highly NexoBrid we'll BLA. were that now see BLA of even pediatric and training, will Turn vast positive NexoBrid better additional be pleased training line center Vericel burn use partner of that state to access statistically significant expanded

believe and have record to the well of a that clinical, regulatory strong we drive track resubmission operations process. success Our teams positions us regulatory

guidance. possible. line financial over Type XXXX this our We financial remain NexoBrid to details burn our preparing BLA quarter resubmission, will and now While the provide care franchise Joe the it's actively to provide for a to turn adding a appropriate to the market more time. provide premature on to call our bringing and I'll update very enthusiastic forward FDA look as innovative for to as expeditiously specific performance second updated product with line at time and about time a the A meeting the we're

Joe Mara

million Starting in also of quarter revenue and for Thanks, Epicel revenue of Epicel Total grew XXXX. million to $X.X MACI statement. related net million BARDA XXXX, to compared to the quarter for $XX.X $XX.X or for were due $XX.X XXXX. MACI to of for double of to underlying to compared quarter the or per and the share the strong for or was quarter a and grew second more approximately response net a of of second XXXX, income constrained of grew compared share included quarter was to increased XXXX, XXX%, MACI Total operating second Epicel than factors. second Net revenue Compared in to million net growth year. in million revenue revenue adjusted in included a quarter was net compared to XX% $X.XX MACI $XX.X loss or $XX.X with million XXXX to the Nick. XX% net to $X.X in quarter XXXX. both quarter when revenue the the EBITDA pre-COVID-XX Total and the for spend the per expenses compared revenue the franchises XXXX, which areas XX% the million $XX the second profit revenue $X.X of higher emergency of million the of prior of quarter of revenue was compared quarter price XX.X the the or higher revenue, respectively, to the in compared million $X.X quarter $X.X operating XX% non-cash same the revenue, compared increase grew our for period XXXX. XX% the million across well loss $XX.X of related share was by of all of quarter of and of business million XXXX. of reflecting of compared Epicel as incremental Gross COVID-XX to profit related procurement quarter $X.X second XXX% revenue The NexoBrid $X.XX second to to by the million million baseline. revenue quarter as preparedness. XX% driven and second primarily stock of Non-GAAP for compared expenses million second in the spend expenses in the loss compensation $XX.X for gross the

and million QX, cash investments of our the and in as to approximately updated we December to for XX, million financial $XXX million in guidance debt. generated cash end quarter, compared the of $XXX had approximately $X company of Finally, operating Transitioning XXXX, XXXX. no as the in flow and

with high increasing our the to previous range. revenue compared full approximately previous growth. driven to are or to We guidance and low in guidance compares Epicel, year the of have expect by XX% million $XXX $XXX total revenue full our year growth range year is we now to full revenue $XXX expect our increase $XXX This to million which growth. growth XX% million of XX% guidance of revenue in XX% to guidance XX% or now The million XX%

period the both of guidance taking driven the by same the half first half half the growth year year. and when full this in the biopsies We surgeons rate compared growth guidance a This of are overall significant in maintaining XXXX, expect previous to our versus and in growth of of mid-XX% the XXXX MACI second for higher reflects the year biopsies in range. MACI first

our line second guidance that COVID-XX QX not or generally that phasing, of Overall, to half full that revenue those in rates prior year XXXX, factors cadence of approximately years. the are for This versus the strong historical would conversion are the materially and in QX MACI do guidance and change which XX% typical expecting biopsy assumes calendarization of with quarterly conversion which drive consistent patterns that In assumes patterns prior years. timing is dynamics and place. we of in terms step-up QX our that the is compared be sequential in with

to of related quarter we stockpile BARDA revenue recognize and per $X.X to QX Additionally, expect procurement. $X.X million in to QX, million the approximately

non-GAAP million we are margin based continue And expect to for expectations, gross of Moving adjusted be and expenses the prior for on to our P&L, year year margin operating for XX.X%. to compared down be our we XX.X% to full the EBITDA XX% $XXX XX% to XX%, full year. the the to finally, full guidance increased XX% revenue guidance approximately the increasing to to

adjusted the continued company. than million double Importantly, in this of EBITDA of updated year the adjusted financial $XX overall approximately demonstrating EBITDA would guidance profile the for full our strengthening of XXXX, more the

dynamics concludes remarks. impact second not prepared the COVID-XX the the the year. that the do assumes also worsen half guidance of in of including materially, delta financial variant our Our This

will the questions. to now your up call We open

Operator

is with from [Operator Instructions] of question first Zimmerman Ryan the Your line BTIG.

Ryan Zimmerman

X on very I if a want to little within elaborate you And those perform the just of well. interplay and terms us for give per versus dynamics incidents could dynamics for dynamics that your going Epicel with the patient bit higher burns in I'm your continues the a thoughts moment Epicel to forward? market here, around And the wondering, seeing. grafts start you're Nick, of in expectations

Nick Colangelo

Ryan. Yes. Thanks,

we're reps where increase greater and to with, As sales the surgeons about sales centers use to patient then specialists clinical roles in volume. support the of that's coverage. on the customer-facing Epicel, our we've and has terms have now terms led believe very as our and that per clinical we we -- of force to Epicel obviously, we engaged in a support the impact reps of recently educate talked specialists. in continue obviously, an had that changes And made increase grafts And the to led optimal that, in leadership significant of and burn continue to number

been kind talking And impact or it's over -- has all past the X changes. sales a the of remains of force X think we've performance I demonstrated theme that about the quarters So year. those

there's feel in and at certainly really sales same contribute that and driving know commentary greater which, lot market incidents know, are burns you dynamics In that's not any population. most force a reopening of a really I terms and burned there's it for don't and out I little, level effectiveness there of really patient reopening but the would -- patient severely critically population, patients. I say may like our so the -- around on. of our And as as dynamics,

So year was buy we highest that was and it talked obviously even earlier this the QX, cumulatively, about in we had seen, and before QX had dynamic. reopening any ups that

sales the So any towards dynamics. market effectiveness I really more than think it weighs force

Ryan Zimmerman

If past quarters, it. the about line helpful. top Got think beat very X% on guidance. Vericel's just or then take, or That's give on by, one the maybe X expectations so. And I

a those or has be yet, -- X. or so roughly the increased And it Epicel by And MACI about past in quarters. combination X% each of X guidance of

constraining and higher philosophy are your So help than now. not you, for your and guide or maybe slightly be of may guidance both decision to Joe, what that us right you Nick, may understand nudge

Nick Colangelo

updated we've scenarios, had for years this is, chime think now, consistent especially in over pre-approach, the as Well, yes, a and start, skis. model that's our we've approach of the where forecasting But challenges out we've tried can on Joe population guidance a in we Epicel, as out always well. twice get low, to And a and Ryan, there I'll I based outperformance. several bunch year -- think Epicel. of we talk guidance already are about patient given we And given smaller there's sort never

that. quarter get mid-XX% really guidance the in -- think we And to too on So then with I never the we've out MACI, want been first we far ahead growth. upped to

had dynamics patient and you've rate, comfortable growth I now, and think we're around pretty a and reopening it where right is things as there like that. out behavior just especially that's some healthy

no really at too aggressive get year. point reason this to the So of

Joe Mara

Thanks this is Ryan. for And the question. Joe, Yes.

add, back XX% again, to in about you about time, go single you which started were last if the Epicel, we guidance. above little high bit think rate year, on growth year digits. a the when Just And then talking total we company a

you're If low to to progression XXs talking high the XXs. at you look there, mid-teens

factored So that a line from And Nick continue in above year guidance. about, we've perspective, certainly, really in with MACI talked to we the as XX%, about rate. certainly growth think seen as Epicel that's perform, total started we then as

drivers. continue We underlying see the to

aspect. certainly well aspect think So that, quarter-to-quarter we're the a as certainly year thoughtful but as on about full there's to

Ryan Zimmerman

Understood. progress. Congrats the on

Nick Colangelo

Ryan. Thanks,

Joe Mara

you. Thank

Operator

question from the SVB line next of Antalffy Danielle Leerink. with Your is

Danielle Antalffy

can and Just a dynamics, seeing reopening characterize the recovery you COVID how quick on you Is mean, are referral funnel? at question lingering impact? back it any the XXX%? point I here in the to this time? Or

Nick Colangelo

some that I'd say general couple market Clinic up catching we down to And bit have our frame. be that it's looking think December. top seem number Danielle, whether of market is track little research X% a time that's little more to things compared but and Yes. to where now with XX% bit, commentary at their we a still I or of are since one, volumes lagging the surgeons, were pre-COVID a probably do levels. pre-COVID to versus seemed -- surgical visits

would recent point So say haven't the in around no up. situation, the to in impact they're back quite those delta dynamics, levels pre-COVID any restricting terms of catching the terms or really not seen but are this widespread of commentary I surgeries variant on. at we facilities, and so

one a any of around we and taking reschedule will think And feel at thing vacations test. number from for so physicians, dynamic. lots take a do in we pre-op cases eye think that think and spike, a growth I receiving, patients really kind is I month-to-month as test our there significant that back or business. in about positive, a have patients have And look that. biopsies, if or choppier the underlying that. surge to less taking procedure, overall, you'll of then drivers have the just that biopsies to But and will increase to tend like record on reopening things surgical step it a surgeons COVID dynamic, we're linear commentary the generally leads little good little the of and we about again, keeping And they patients,

Danielle Antalffy

surgeons. That's Understood. follow-up one helpful. just in And on growth quick biopsying the then

surgeons said But years I online? those would are surgeons XX% past biopsy I'm to think wrong relative you to if starting there. ramping come that me are new how growth, correct as

Nick Colangelo

Yes.

kind think their say will we'd the when be. prior patterns of as what from -- consistently for consistent seen years. surgeons new new of the implant the terms surgeons that year-to-year I days early get in are just biopsy But -- it's how behavior So we in we've same

So we expect that to case. remain the

Operator

of line the Stephens. Cooley from is question Your Chris with

Chris Cooley

Congrats the great on quarter.

step-up in it Just may. grafts about now think wanted and patient. When follow of terms number X just I on in bit the math stepping Epicel in TAM revised if me, applies the you of I on a of here, for here. the the for little kind you're guidance, right if days up doing really still to that back up in I'm average, early

could would to growth annual -- the that Just in terms of say, for wanted sub-XX% the different say in I case think in step-up is we when of realize but that. you're relative confirm to, a about one, -- each see the guidance. -- of step you the if And still TAM I the I patient grafts when number terms in at increase implied look up,

we adoption about So where just think trying were in to curve. that

Joe Mara

Yes.

he and I'll Nick add can. Chris. thanks, start, to wants So

not back as I back higher you we're certainly late, a $X really few the more the more right? step to near kind sales, on run obviously, prior strong has Nick improved, think quarters. run guidance, shifted the obviously, force on rates, quarters So we're look quarters, a term, If you're quite the right, historically, much rate. at bit and about million we've we prior of business at quarter. some here. $X of million higher. but the if $X in this rate, rates' talked was past last a about plus But about had that It's last the We the talking think really think those Epicel to the take has you over And quarter above as sense that million of field has a I guidance, mindful think execution run run

And take a I would is plus what or patient. the that think higher grafts relative few what you're it, million we at if that, think a about number step believe. is, what patient, that think of XXX TAM you average there difference we back, about years or and to per is ago average, I ago is higher the think is $XXX now you couple we that's are talking that -- $XXX a on to of years a And As really seeing key call number. means per XX is said grafts we plus. think I we're TAM, is what utilization what million saying that saying think we're the But say, I I

number XX that historically, was So per patient. around

actually closer XXX. about it's to Now

at Certainly last think addressable that's we've a over it's it's at So that $X,XXX, plus. rounding well. as bit trend we some the there, a and certainly, I But we market. think price a average quarters, taken of think changed $XXX look bigger few an million

So now, is as where amount we fair of think about Epicel about opportunity as we a TAM. that still we there's think think

the So increased a your rounding of a to based to up take continued that bit as we're certainly, has question. is to there, there's that And think of which the trends guidance, date. I about think, and But part bit. answer on performance underlying in seeing we've TAM again, the what we

Chris Cooley

what that here prior from Super. The And in then baton to maybe, bring there? resubmission. follow-up I might the expedite notification can That's you broad guess, quick me. passing the transpired table Could NexoBrid what's see Nick, on and paint really as helpful. specifically you challenges just the you the strokes, for you think And just the of any the post a here agency. process

Nick Colangelo

Yes. Thanks, Chris.

front, remarks, a experience clinical couple during and Vericel BLA, a of their matters regulatory on dozen prior supplements, MACI several the principally As we respect approval the my to and great great and years. a probably I success the CMC over mentioned past not to deal label expansion related tenure just of operations with Epicel for the regulatory and in Epicel with team a have deal prepared MACI

Affairs then Halpin, et are highly COO, so North on starts side, team of Genzyme So the business members leadership, that American the experienced as it's clinical it our whether Regulatory was realm Sanofi And CMC experience for in the his Head leadership. with of well, of unit, Mike cetera. the side,

NexoBrid. position with track or just XX given record So that and NexoBrid FDA. of we years vast great great of think And with history the brings, to deal working experience the of a in MediWound well I bring experience -- then a a we're leverage bring

the it's feel it less us, lead still quality MediWound in a the have say and from it clinical And we bringing about we to the bit I market. we about a that So forward. bit confidence would path about sure do Obviously, and to deal of to good data with the a look great how approval can a fast more together for FDA. ultimately probably package we will little making little forward put

Operator

next Your with of line Jeffrey Thalmann. Ladenburg the from question Cohen is

Jeffrey Cohen

So a from our couple end.

If your comments your resubmission. a just from can you'd the OpEx call for out follow-up beyond XXXX? R&D effect that on Any little you on Chris' bit number

Joe Mara

material don't I see Yes. impact that having don't really the operating expense a on line. -- think we

Jeffrey Cohen

and and as then on through throughs. as waiting you further us, And that people it. end effective Got on far scenario Okay. side the the think pull then on biopsies pretty out and the being you secondly, see the little was please? pull on us other biopsy give that do How pulling you sowing can that COVID implant side? strong as Do -- QX a flavor for MACI into

Nick Colangelo

Well, growth The the what biopsies. is primary which yes, another the is And consistently on in with that driver biopsies just driving key side. we and were where key in increase only been in strength XXXX, the Again, the year. is average in really to that, now. driver consistent to we always growth right surgeon, the that's biopsy half continue stating expect growth, see we've not biopsy that's we is surgeon start per I'll of which second

So up year, we not really of into for but that's and just so beyond; second XXXX number set think half all one. the those this dynamics well are

prepared last comments, heavily half, of second and guidance which other year his is -- little the the half MACI, for the assumptions is year on second half a year. where XX% it terms -- of mentioned as the which In half our skewed that into the than recognize year that first more suggests XXXX, of has been think the XX% I revenue since back consistent implants, Joe to our it pull-through of the for in important

expect as timing any might on. we factors that dynamic see, any so mentioned, absent the and related that's changes So would conversion you COVID of to that, have on

Jeffrey Cohen

Okay.

So no versus you're percentages thinking number been over through material pull past you've of the years? that what factoring

Nick Colangelo

No.

Joe Mara

talked other as consistent, it's in really we've say seen in remarks, what years. the I'd about we patterns with consistent historical prepared and

Jeffrey Cohen

it. Got

readout, Okay. quarter. nice Perfect. Strong

Operator

from next of is line Your question the with Bordovsky Sam Truist.

Sam Bordovsky

Just start Epicel. on to off

You curious touched go on it but little you're there? and the in more would a reps in about new I from are now? account Any maybe be remarks, new wins account the to surgeon the centers coming sales force. to hear prepared wins if the bit dynamics burn can of into deeper And these number drive you helping new

Nick Colangelo

Yes.

in I Sam, talked think, hadn't in I the burn call -- mentioned of about way either we've it it our think used Epicel we on I never a that last used in had are seeing we say activity Epicel would years. number that, past definitely centers the is, or

in our impact sales of having that are terms an there's And doubt customer broadening representatives no so the base.

that keep centers to in tail, there not routinely. Epicel that see at have the also You patients burn mind may some are

more appropriate of churn terms patients, the see those that they're our past And the expect, of little And Within admitted, of think reps think seeing the also that think centers, discussions having you'd new number customer in impact of an tail bit there's they more as and a end terms have often so absolutely quarters. an present, we the impact we from can appropriate treatment are broadening et they cetera. seen about But plans, who I that's on several grafts surgeons the it's, are over we've in with do I patient of base. things. per patients educational our

Sam Bordovsky

just think maybe thinking as about to surgeons, sales getting of the sustainable and the growth, Great. more amount a helpful. 'XX, assumption early a about rate -- start mature that reasonable And little right is little but here, into surgeon growth maintaining for forward? force a going XX% then That's you it's

Joe Mara

Yes.

So this is Joe.

obviously guidance 'XX. haven't we on given So

surgeons we're this that strong We talked about number in a target. about, terms talked year. as think position I we MACI exceed of think in to we of XX% on

we think forward, believe growth as material be that a I we driver. still look will

think But the percentage that as what we'll drivers, we MACI the long-term are growth see. think the rate of them. one So I that, biopsies looks also per over think the growth I surgeon, that's about conversion And like, drivers.

where But pretty certainly -- continue like year. to what we next that will But will we'll see robust think that be for that 'XX, important. looks be into to still So have sure.

Operator

Okay.

is the Kevin Your Oppenheimer. with next question of DeGeeter from line

Kevin DeGeeter

I on being whether calling XX% these amount appreciate time pull-through, say, provide from volume how now potential well high-volume of surgeons, Should given the general adds? you're with are had you if how It's we now. the regard well. still ascended great success to recent of same there that surgeons about the you've follow-up to would as orthopedic rate. of medicine see And bringing on trying on about with the have of the the of want period MACI the years of are But number maybe adds to more high-growth added a to throughput you're maybe from potential which sports ago. -- a you that these growth. some number same coming as volume and on X to some an I'm think perspective think update of how prior the can to volume know sustainability in as And X potential from question the over I of of market, samples or surgeons should relative surgeons characterize MACI and

Nick Colangelo

to Thanks, Kevin. Good morning. Yes. this to you talk

reps, X,XXX into so to XXXX had surgeons. XX% targets, still follow-on point. ended more percent. to when Obviously, X/X. the added when we'll XXXX, expanded X,XXX, biopsying our would I when X surgeons target said that we And of and that we at versus adding we Joe's response were days So grow that with we believe we were terms say it's XX-plus kind XXXX I'll of we in even surgeons universe than in launch X,XXX adding our initial in years early XXXX we less We

math the call and, do can you so. X,XXX So or it,

into barely So you're surgeon base. penetrated more still X/X than that

terms we won't growth surgeons, on years several think surgeons; there of there's that's ahead of and number think are so target saw dynamic one. strong in that So the based our to same see we we adding reason no initial

surgeons, know, for calling high-volume of repair you terms surgeons. In cartilage the we're on those potential as

no my with this They And on we're penetrating of expanded surgeons. surgeon low. as there's in so injuries. at -- surgeon potential a for The really cartilage numbers patients really point from perspective, number basis are this per in large still these quite a the base, very difference see

so any, governors on any I And think we do. put our what guess, can target surgeons don't we of

Kevin DeGeeter

on and is Vericel surgeons patient. than available, maybe of question your then graft you're different way the kind trying for understand severe to sure now of a more patients. users driving Epicel. to an a Is can more using a going the this years the in are little it per of access Epicel opportunity inherited is level when out I'm Appreciate to the -- just you're you a But more getting education numerically seeing how more TAM. great of if in Is when for all for And centers high just of of I it broadened product area just patient, versus making it as way much assumption? using is revenue higher mean, I so differently medical back to that optimal more want the you just Great. optimal are docs broadly bit understand the comment to that the the the expand job who product more granularity many doing TAM there's patients you Epicel what's just in follow-up volumes. ago?

Nick Colangelo

Yes.

we're meeting Epicel very referenced basis, of at and certainly point affairs an a And mentioned, of you -- on the this posterior where, our of seeing our reps instance, clinical data one patient -- the in for well, with individual then an there's education do team support surfaces. as earlier And use our largest on specialists. medical presented our at certainly, I customers customer year, I as base. the So that of a expansion has think lot on medical a to important from it

have it centers with surfaces. on might on So anterior surfaces, for that's as use have Epicel additional have routinely, an used posterior not autografts who may felt some comfortable used might

grafts, just they role graft believe as we've as estimates there's we So of get grafts initial these we've the an a volume the extra that we the have process, has And we that used little number might ship if burns, them, program then needed and you given might often, well. severity impact. be are of the where during that a implemented an in And quite tell size initiatives manufacturing that and low. extra Epicel of which seen, having educational

of we folks So impact. the it and is is use about biggest the process, our that together the support really reps, optimal plans on surgeons treatment Epicel sales and educating clinical in having engaging earlier putting think

Operator

the H.C. line comes question He Wainwright. of final from Your with Arthur

Arthur He

communication with the And This Arthur up between also for I NexoBrid RK. you're a for feeling wonder, the I meeting I regulator, site perform have guys just resubmission? the with missed do follow-up had may to just on your the the about submit FDA? regulatory inspection resubmission. you timely the scheduled how BLA -- --

Nick Colangelo

Yes.

FDA. I this with actively a as So remarks, on certainly, A -- number for my we are my mentioned Type -- meeting prepared the one, in planning

that meeting the that's has So months days. that's FDA typically regular and action. X request days respond, an a scheduled to regulatory is a -- you the within meeting after within FDA XX requested, Once XX

So that's the within frame operating. we which kind of time are

a to different it's meeting little meeting with a a in do possible. that So package for request. submit to that obviously, meeting, have the instance, as along you Type we soon a In meeting, than, are as looking A pre-BLA

instance, days front-end work gets meeting done a where out. C scheduled it versus, Type more A be a there's for XX to meeting pre-BLA in Type So

have it but ahead days you that. to a then So you submit request early, package XX of

when So the frame is a analysts within. going scheduled the in timing. meeting meeting it's and Again, time. just requests that's not pretty certainly Once the working on time the at short submitted, so we're a and investors but to And gets in scheduled update difference that, order. and comment on, package meeting we'll the are appropriate we're beyond

not prior you the inspections of need that the occur that's to can at But engaged to approval. just certainly has mentioned terms resubmit discussion we inspections, -- point. as with and In been an a this we've before,

Arthur He

Congratulation on a quarter. strong

Nick Colangelo

Okay. Thank very much. you

Operator

questions. further are no there this At time,

Nick Colangelo

your Okay. you morning just in for interest continued saying Vericel. thank Well, us I'll this for close joining by and to everyone

the of to mentioned more executed the growth As even patients remain first the strategy significant continuing focused drive well we half on company we today, and extremely ahead. to and our long-term products obviously, years and in profitability XXXX, deliver on to in bring our

great and a again, thanks day. have So,

Operator

today's Thank concludes this call. and for participation. Ladies your you gentlemen, conference

You may all disconnect.

Vericel (VCEL) 4 Aug 212021 Q2 Earnings call transcript