VCEL - Earnings call transcript Q3 2021

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Operator

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

Eric Burns

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

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

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

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

Nick Colangelo

the for in healthcare the of revenue spread cash Delta the The additional Eric, impacted operating operational delivered COVID-XX patient Thank and networks to quarter. everyone. positive the behavior to resulting growth, quarter. adjusted and in morning, and and generate quarter, and disruptions flow dynamics you, continued solid EBITDA, the the third good results MACI headwinds and variant Despite company commercial top-line revenue clearly

nearly compared of Epicel had MACI for revenue to drivers the very another growth XXXX. growth and with quarter underlying strong, key the However, third outstanding quarter XX% of remained

generated sequential we cash the quarter. XXXX, third to sustained decline profitability operating sequential half a and up adjusted respect profitability fourth delivering patterns, seasonality for for as top the flow. Importantly, second and the perspective, strong expected and to MACI we company With fifth drive quarter continue line from revenue, while quarter consecutive revenue based typical growth EBITDA of the cash step in flow the on historical in the positive

quarter, the deferring saw and July years reopened in decline vacations travel recent as patients procedures due and During a significantly we economy to than the third greater in resumed.

assumed performing rates of While the those pronounced in of cases highest the the the due MACI recapture the we some impact regions second start most quarter, the that areas was had we'd variant COVID-XX activity various Delta and case later half to not in deferred did that country. on of improvement in to some of quarter our the the in expected country the in materialize The those of best regions. are territories resurgence

was growth COVID-XX lockdown which of levels that growth. outperform a reopening we the in each the implants of Importantly, initial to would And quarter of within one exited with estimate last as backlog converted and winter. the the recaptured dynamics backlog about continued in two We revenue. under the periods million equates to result quarters. COVID-XX We case cases of had normal backlog disruption, implant XXX to cases in XX% during than again, similar patterns, conversion we have spring of Delta of and MACI more approximately to biopsy that prior XXXX; the instance, the $X in as surge, a variant

QX we're growth in move compared we've and of growth recaptured to that which since exceed into to generated MACI backlog, which quarter, MACI, a launch, of more and highest we biopsy fourth the is COVID-XX this approximately seen XX% QX driver the record growth in overall percentage another track the remain of grow drivers per recapture is key more we will year. Joe with due MACI orders key as more the current to year, are XX% we than growth to we've results revenue an so, for to-date to XX% these gradual operational the From regarding its and likely to expect We remainder year the projected standpoint, year. X,XXX close XXXX. target the discuss although biopsies surgeon, continued to cases believe the detail, underlying high growth of similar pleased this We that respect uncertainty for that be will surgeons, of and the in the expect grow taking on sequential majority the to the XXXX, disruptions acceleration an to a revenue quarterly Even Biopsies believe very year. from to long-term expected profile. with for for support by surgeons growth full number key approximately will

we important MACI backlog have this that to acceleration enhancements our strong uptick XXXX, expect already not surgeon MACI patient growth an in for materially. more continue trends timing of in XXXX, normal of we reimbursement bolstered year expected return in and to to double-digit the surgeons, growth key on further normalization all progress With biopsy continued based continued of profile. change XXXX, COVID-XX forward flow, assuming do an the carryover, and conversion Looking with biopsy potential and biopsies drivers MACI per for a an We've also thereof. reimbursement growth that expect achieved rates of in increase

of defects, XXXX. result of policy United fatalities compared of to United third doubled with the include through Healthcare's year, patella Healthcare medical has a more than patients of expansion the to number quarter As this the

techniques In CMS on clinical outpatient covered contributed of in will to and for issued performed to that be to added standards the one on general allowing ASC was that procedures number criteria small procedures well safely performed week, the were meeting determined System a these setting. addition, advancements list, procedure invasive last the the XXXX. Rule an of This based is reinstated ASC MACI year last for ASC procedures setting, in the fact Final exclusion and that and list determination are as less in an that list and routine the Payment as remain are that largely as practice

have limited care, commercial And that determining flexibility greater this for our MSCI in refer these determination of ASC plans rules preferred customers we that the allowable to of sites list Medicare is MACI in procedures. site on certain provides While having CMS so procedure business, care important. covered the for selecting

key in surgeons. look market performed the our number invasive these increasing to MACI to by a we arthroscopic development the addressable step design We field. delivery Finally, the instruments, could another cycle patients. to current details is MACI on key process forward a providing program in continuing management we a of which of increasing the this for and believe of We feedback on billion important $X additional beyond in arthroscopic MACI and opinion of our targets we've the future. for significant MACI and that significant make strategy near positive important leaders custom even those making physician of in that by very believe surgeons by also finalizing growth the life be from driver MACI, mid-term are progress received less program procedures penetrating and the simpler only further perform procedures We're system, open

the quarter the for burn achieving over Epicel, Turning straight third revenue revenue led compared to XXXX to to $X and of our outstanding XX% franchise. revenue, growth another in year-to-date for fourth million quarter care quarter Epicel. We which in with XX% has had growth

and number for the with burn of continue to biopsies, growth significant number the taking per increases key in of with drivers grafts We Epicel see patient. Epicel the the of number strength treated across centers patients

Given second as continue meaningful high-growth we believe our franchise part the build strong the our business. we're commercial sustained well-positioned into to into a performance, penetration addressable expanded of to overall that market, we deliver more

FDA the forward leading Turning partnership with this and Type BLA. very FDA. participated about the recently burn is We on franchise our discuss updated information to results third over is to as resubmission to financial of The expeditiously adding issues quarter from meeting questions, the mid-XXXX. next to phase in and to NexoBrid bringing currently and turn work market as are in BLA NexoBrid team A MediWound, a we this productive there look the with the call path I'll address agreement Vericel product the and requests targeting and remain potentially We Joe in innovative possible. a care forward now to financial enthusiastic our to guidance. the

Joe Mara

compared approximately included Thanks, quarter $XX.X to the of increased the $XX.X Nick. the revenue NexoBrid compared MACI third million revenue $X.X $XX.X million, third Total related respectively for in revenue preparedness. revenue Epicel for of million net and and and Epicel of BARDA Starting million revenue $X.X Total statement. to included to quarter with the of procurement quarter $X.X MACI XXXX, X% emergency $XX.X of third the also million revenue for the income million of XXXX. response million of by to and in quarter

the $XXX.X of total procurement with million XX% the in increasing to revenue MACI increasing revenue net million, the revenue compared Epicel increased third to to to NexoBrid. of For XX% XXXX million XX% and revenue related BARDA XXXX, quarter same of period to $XX.X $X.X $XX.X million

MACI’s earlier, COVID-XX As quarter impacted Nick third were headwinds. results discussed by

million $X initial by revenue approximately MACI the to on of XXXX quarter prior after in third to in lockdowns, a of was XXXX it from third the quarter that which due QX the elective important quarter MACI initial that of is the Additionally, quarter related cases estimate when We comparison. year-over-year shifted COVID-XX that COVID-related related catch-up revenue restrictions impact impacted mind positively keep the third the surgeries. to the to comparing XXXX, was significant

to XXXX, $XX.X in underlying over compared of our increase revenue as this non-cash the across to for Total period quarter of So areas X% The an revenue the Gross which to quarter XX% net million was catch-up third of million or million $X.X XXXX. million of a while primarily of basis, adjusted MACI quarter of per was higher The net for product was the $X.X for was QX higher XXXX. XX% compared the for operating price, mix. manufacturing normalization in stock was the MACI to XXXX the reported of in on $XX.X in is the net XX% spend business million and were constraint of million $X or the $XX.X same EBITDA net year-to-date as the operating $X.X quarter growth. profit all XX% revenue higher million expense, more quarter is headcount stock estimated of $XX reduction excluding $X.X million a the non-cash million factors. of for was the compensation expense increase share quarter to or related well compared share third of quarter for XX% with down as compensation consistent share a to or driven to related COVID-XX in loss or for the expenses third to compared due expenses or Net by spend in $X.XX XXXX. $X.XX for the compared due per net XXXX. revenue income Non-GAAP quarter revenue primarily growth

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

end and Our year historical and previous versus patterns conversions would be those conversion rates years. COVID-XX biopsy that would or dynamics assumed MACI generally with of not timing line that prior at guidance normalize least in patterns materially for change by the

converted majority recent this in conversion expectations full as that to next that XXXX. our in implants. the a And cases the for year, to MACI in with the that impacts earlier, growth. to year. half anticipate a will the calendarization a disruption cases $X growth low backlog on demonstrated cases year. dynamics, mainly our reflects convert normal and of full rates biopsy we in exited guidance of implant when guidance this on Nick timing range have worth year of from these million will updated incremental updating in fully quarter conditions are given underlying by new mentioned now COVID approximately year XX% normalize or will With This to decrease and Based being surgeon our Not would of the the of our demand that the we not the our second XXXX in we convert change until COVID related biopsy backlog

to increase Although to-date. seen QX, since from MACI acceleration which quarterly revenue patterns for of COVID would would in ordering MACI revenue and and our XX% the sequential MACI QX fourth over represent headwinds quarter launch a highest also start sequential an highest to remain, we be increase updated QX, represents implies have what the of the guidance the

With the as convert growth to growth drivers growth incremental to year's overall expected allow MACI the for Nick the the implants as other full expected with further should year this now majority year, a MACI well believe key growth we biopsy discussed earlier, of to next next rate. backlog XXXX, that MACI that in increases in year acceleration of this exceed

Moving to Epicel.

results million $XX most year for already Our start guidance updated guidance, be full and the initial rate any as Xx rate guidance our recent full range growth results a Epicel year. our low with in our anticipates the expectations year now $XX to exceeded growth Epicel versus revised approximately year increase full million in further year XX% approximately our represents growth year-to-date full for over the prior to year, have revenue. This in of of a

we of we Finally, started not updated the total, expect assume from for growth of the was to and XXXX generating full BARDA approximately impacted margin year, be full more revenue which headwinds full our in time the now for XX% to range $XXX full NexoBrid revenue company Apart year outlook, now which the XX% XX% revenue that to gross With million continue this track since year. year $XXX $X.X XX%. the COVID-XX. Vericel’s record by year full in margin expect million brings total year significant XXXX, growth strong at back this representing COVID-XX, EBITDA expect million our revenue year where of from guidance approximately we adjusted the to would over We of launch approximately each be MACI. to did related severely XX%. roughly In

decrease million. our approximately for expect of $XXX guidance We to previous below operating expenses to slightly your million, $XXX

that double $XX Importantly, our adjusted adjusted of XXXX, profile our of to remarks. continued gross profitability concludes as full the expect prepared increase we the guidance margin EBITDA year EBITDA profile further for margin forward, will company. approximately would in strengthening year the financial progress. looking both adjusted This company's And overall our the our EBITDA and next demonstrating essentially continues the million of

now open will questions. the to We call your

Operator

[Operator Instructions].

comes question Ryan Zimmerman first Your from with BTIG.

Ryan Zimmerman

the questions. morning. Thanks good taking Hey, for

pushing of dynamics biopsies XX% were conversion want bit. I guys I year. the to greater think a into and But first ask MACI next the first So on-track, I you little the growth past on for half kind appreciate kind of 'XX. than in the

XX% maybe about for the talking you're year. Now growth

you kind So, rate based your your biopsies for on what expectation is what you saw then fourth can discuss run really on year? quarter and just of this in quarter the

Joe Mara

is I'll Ryan. chime Joe. This start Thanks, Nick and Yes. can in.

-- you we'd I would that on I the of last call was call, half MACI talked about more I last we or So, that in the XX% first about talked what say, as XX% think growth. range kind plus when the revenue. through of on year, we the in And biopsy we think look roughly seen year-to-date at also

now certainly the basis a of the say, first biopsies did be you more look the we full to was year And cleaner XXXX, in quarters. kind of were the over there the in saw systems, third the biopsies of some kind in full seeing to we're of and the year, compared XX% is year. you prior first what come those to healthcare the and quarter. those as through what over see XX% quarters we saying half of which if a say, in I COVID at of you we you year kind on we would disruption had a I rates first When the So, would which is And, obviously to close in compare but probably some three growth XXXX, a biopsies impact broadly, the of comparison, of was disconnect all see across quarter, bit were the look for that expect year. half

sense So, we gives year-to-date full the together, that where what I XX% the we you being expect and year. and a kind are of you on of that think put also

Ryan Zimmerman

a the business. Epicel becoming then And more Okay. is portion of material

few I material. now necessarily the rates years have growth a the become But and think back wasn't case. that pretty

next environment, Nick, from? think the normalized a such can as And Epicel-like so, how now sustain you you're about you in seeing year that think for about growth Epicel rate an that do growth product

Nick Colangelo

Ryan. Thanks, Yes.

as maintaining more the So of year biopsying per Epicel. and drivers of continue obviously for and outstanding And basis patients form to this on the burn treating has that patient, going will utilization focus an of for that increasing been sort just the centers number grafts grafting, growth forward. the of we higher growth

it'd of penetration certainly continue XX% silly So, I base, as say, to year-over-year. growth But centers. broadened expect those deeper we and we'd user into be think, expect sort Epicel grow, of to have then to sort we’ve the

So, of we're this do years we Epicel for do the next for year. early point to growth prepared certainly that guidance sort next We'll ahead. continued year. give not at But in expect

Operator

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

Jeffrey Cohen

So, few ones. a familiar

your of you us firstly, be patella and So is? or defects about give could large United pool the percent how a that talk patient sense revenues what may of and

Nick Colangelo

Yes.

plans other I XX% for the par what for is, U.S., did now payer patella cases mentioned commercial of that And expand to people of on non-Patella as, are Jeff, the this the you its about is as way cases. to include about did cases. we've Healthcare in said United basically and basically we United with earlier we wanted of right? So United sort know, medical rates Representing year, -- sort the Healthcare approval we largest commercial And patella think policy think lives.

think proxy, of be payer percentage a what if of kind you covering the business how our think non-patella of level think largest covered of by I can about portion case. if it our business to high at United Healthcare covers terms -- about United. the a Well, or case our probably good now just So a they’re that's in a be would it lives, patella of that is portion or XX% represented

Jeffrey Cohen

Would of talk what a into uptake about filing? surgeons to expect little Class the there? you expect bit minority? would far as as turn you that tool? the from you arthroscopic a out the could maintaining majority And X delivery And that a Would cases or be

Nick Colangelo

don’t little would sort it's arthroscopically the forecast of done of I a premature the what -- through think Well, percentage versus to I cases be mini-arthrotomy.

I is think back, where taking that it less Carticel procedure, path a on when to another invasive a step this franchise the from are you step taking moved took with invasive. MACI, you we made highly this

And past of as available couple Over defect then has debridement tools -- of that course, sizing had implant of of more the very for basically then popular. sort and become uniform years, invasive and sort we've a less arthroscopic continues simpler the potentially that's this that surgeries in Where highly take these growth. procedure, you And invasive just invasive it them and and even journey. what surgeries, the right? minimally fuels into see industry on turn often, you

whether it's viability that And course arthroscopically. be criteria we've over to finalize the this for very And to on of design of to X sort expect year, able to will relief part next end cell been or other the that when of through and our that's demonstrate of that's working The year. do and the kind demonstrate are want that you delivered that our group don't we designing by number so, cell it's on reusables, can meet through MACI instruments X considering. do feasibility Last is a been studies you able disposables minimal instruments, is about still We've first of year, with the the KOLs talked thing path project fact we're the instrument on. the the closely Class the arthroscopic depend whether we're design Class question delivery. device impact of of we a a you and

to who with but cartilage very pleased of only sort method. the of is we're do I of there's prospect high so, two as procedures, volumes there delivery dimensions do certainly that. repair. surgeons mentioned, One open are Obviously, arthroscopic And

be certainly up who And arthroscopic so for current is us. that part MACI that may We obviously, open And then, could the of addressable would believe an identify the case patients. users additional are alternative available. when there market delivery

as about year it we'll excited early next project. continue and proceed to more with we're provide So, details we the

Jeffrey Cohen

the channels you U.S. any far could two talk lastly, any agreements ongoing outside for the activities in activities about then as -- And place? any or or products other as

Nick Colangelo

as required these and acquired approved was Yes, this which on know, we those U.S. sort when our U.S. so, the U.S. have the gene advanced going the principally to Jeff here in business manufacturing for you challenging focused in production would changes you know, opportunities. impact we're EU, cell therapies, years very we MACI, weren't market of for ago, to plant some

to road, European continue to As we to may think of to allow back we more expand the rooms broadly, design facilities meet go as sort down can certainly clean requirements. and And capacity, we Europe. us that

would So opportunity manufacturing the by the same MACI. that go dominates geography entail. because the of we to again, U.S. Epicel, have U.S. to I in thing build were of facility the far life we’d if And whatever outside shelf think Epicel, essentially a for for market

say, And again market, the so, remain that focused to on which these fair for least the at we'll think opportunity. I it's greatest two provides U.S. products

Operator

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

Danielle Antalffy

biopsy other I Are the think materially worse, of a could MACI thinking get rate the the you've that as next one year? XXXX? that why have maybe then plus guidance. there growth the then outlook rate the Just appreciate XXXX MACI and the year, not rate, for talking up. way conversion to about conversion better. right to growth to some be appreciate, rate dynamics I backlog, as follow conversion play right be question, Is in but arguably long got doesn't But about you're this here? about not growth at I going XX% give is way And the

Joe Mara

I'll is this Daniella, start Joe.

broadly surgeons, as we guidance ready kind not a the you've think I think give speaking, of in which we about we're is growth the to to. continued double-digit number But, XXXX So talked alluded expect remarks, driver. of key prepared certainly on I in really

We have expect conversion the that moving of biopsy and to do backlog biopsies per also We expect into rates year. a surgeon the increase. normalization do next

think of we're XXs in kind kind where the this XXs ending based the year, we're on right speaking, in broadly the I the low full on of year certainly So year. now,

higher So I kind absolute about the part I of hard directionally, think, rate, to a we us it, these think are growth mean, pointing say, pieces be to but but will of number also XXXX. it's kind of biopsies as certainly

Danielle Antalffy

then you helpful. as you I'm is the are discussion and know, could product MACI on know That's if this Okay. just Nick I you the QX sort on market now phase, several because given of launch? dealing probably MACI phrase of in a curious and in fact not seasonality unfair the for that I this we -- been And us think the But seasonality early with And usually headwinds. with adoption just dealing COVID-related question is has you're still much. what about for were inning asked quick pretty when sort the we're a about in where we years, --

on much. in So Thanks curious launch? what say the we about where could just so you MACI are

Nick Colangelo

Danielle. Yes. Thanks,

to this the our as biopsying primary But surgeons, about as often were up in in salesforce we've say. we obviously and that increase year, to And relative early you of we is growth and and And, and growth basis. a company, for X,XXX. that you third our believe on terms even we that So as our the think place. driver, XX% increasing second, first to about year penetration, the look expanded in surgeons grown cumulative third as more on biopsying that to we in expect the focus expanded even full we of the we year target, of had used to to X,XXX grown as XXXX, sort those XX% initial at it's back the the we we've point launch, biopsying inning innings, we rather drivers if maybe in certainly as XX% about, the than said, by remained we talk surgeons had salesforce,

biopsies So dominant still growth increasing that think other dynamics surgeons have will kind schedules. any then then growth the of disruption, on surgeons absent And is expect COVID full we per there talk drivers, biopsying surgeon, which ahead. the and we the about, of years we become that's

well. you're will if growth per last candidates next they again, patients conversion more are believe more biopsies year good we versus because So for getting it's year. year, more they we overall expect expect growth more and And sort higher to certainly And our surgeon, This identifying see increase that have to that higher continue surgeons they're of biopsy then, as conversion once post rates, normalize a COVID-XX, or because we experienced rate. volume Epicel.

the there is forward. going coming we that growth knowing no all like putting years down MACI that pike, competition of expect together So, for and

Operator

question Truist. next from your with comes And Sam Bordovsky

Sam Bordovsky

Thanks the start questions. the the with salesforce here, on business. taking for the I'll just too of Hi. ask side MACI

where Just And hear new there? think tools of the some productivity peak of productivity were more salesforce, productivity? they how peak then broadly, think the you gains to how of newer in will there are terms made year the that about introduced of reps access you with be relative that for about sort side last to some of curious the

Nick Colangelo

from actually salesforce and surgeons, the Yes. had experienced to new be of to would reps of country commentary. growth terms additional our on cohort XX going sort largest Joe We sales XXXX, year, leading reps in in continues I'll when our last that, case. in XX which add can since expanding period, take even expect mentioned made sort reps that But, we have starting had QX we sales Sam, this disruptive you're that comments you throughout and salesforce. is highly expansion any and and in were of that of what board, bringing the implant biopsying back

But looking again a a would sort this know, are to we when us we the justified. you next by end year to a there expansion. quite and that'll of of few year, activity be say, expanded And the for time last we we or years. of potentially additional be very last of pleased that further expansion -- targets expansion expected years are next So, end a year, will with get couple as be we frankly, we to

good about really their sort feeling to When per per of think rep productivity contribution in had about we to-date. about you $X rep, gotten million So, the XXXX.

And of is about said million, XXXX would to have which expanded, expected absent sort back on of sort sort where year rate. kind the fall or estimates we this of because year then, COVID-XX. to $X.X But at the run out got this million back But, we of range of $X that would exit XX end COVID XXXX. exit we with just of be XXXX. in of as territories. the expect a can back you And we consensus there pushed As were that end lower look we of at

grow Obviously, back that rep per revenue, with per go a productivity there. further the that kind million sort right And we level from and up continue dollars If around you're in to couple MACI of rep. to from then that the expand productivity we of expect. you're will of $XXX of rates million don't

Sam Bordovsky

I Epicel salesforce, and the of where ‘XX? expansion into the updates Great. business. at there’s moving side terms think that on But we're just you. And Thank in if there we sorry any -- how in of the should If how this. then the about of -- missed

Nick Colangelo

Yes.

on NexoBrid at clinical X So about our that Investor end the expansion NexoBrid territories launch, sort for we'd of we'd launch. of with about at sort territories plans time, the a of ahead we call low last more of expect had it support ahead full And XX talked year of the or ultimately management and XX to in clinical the and specialists the XXs about, be range specialist support team. territories Day and the

X a with leaders. clinical X of positions we're over specialists, sort and super a course Epicel, few territories, we the up this Given couple strong have about year, ramp management of the support of added to

launch that NexoBrid and that. we that. of we'll becomes of it we in the roughly kind a but at clearer, that's will we'll next contemplated are through of range ahead a the I of take complete think timing further, so expansion And And potential where the as we And course, progress look be year now.

Operator

comes Swayampakula Your H.C. next question with from Wainwright.

Swayampakula Ramakanth

of couple ones. A quick

Nick issues third really appreciate because comments were impacted explaining you the you COVID-XX, of especially for during performing some the the MACI. some that areas is of quarter. the pandemic first faced -- one The folks actually your for In those best by of said,

what So fourth specific how on quarter are experiencing the they’re now? those areas, they -- in any commentary

Nick Colangelo

summer this experienced I were kind morning, two and One well, and in of this on. was disruptions dynamic throughout reopened we’ve sort there COVID economy were of and Yes, folks the it to of and as reopening discussed think, as ends kind so the both sort right? QX, traveling

of sort but surged, of that determination sort have timing go we a kind West. on sort variant of a exactly expected and for of parts of that of you'd that's the in surgery. so And a of the obviously, kind the Midwest when of patient-driven once Southeast, would sort when in they recapture, Southwest, waned, Again, Delta MACI

sort what say, -- dynamics mostly and I'd gone. of earlier. perspective, described the I probably kind that's so, we that's of come from a probably think drove And patient

on decisions are wide or some hard I I'd widely restrictions and basis from which system and think us here institutions, the it's that make as individual other quarter. a healthcare opine to is in either certainly sit was of individual the reported where that. on we say aspect, saw for patients third there

restrictions no were there in pausing some surgeons -- facilities. saw either were period of individuals do but surgeries for systems back that individual either institutions there could or elective surgery or number had healthcare those time of certainly you XXXX, elective restricting you the like in individual So statewide

that country. clearly so happening And the sporadically for pretty resolved. been much I part, around those And was the most have think

to in sit So we much again that couple predict see we happens too next fourth but here quarter, and the what months. the can't over don't of expect of

Swayampakula Ramakanth

the there that backlog is guessing ‘XX. I of at you weaker And it a historically if first of it looking these you is I is of I'm correctly. if -- quarter of generally look quarter it -- quarters, one the first -- at think Okay. If X into look which numbers If million for quarters right? approximately first that. more Thank heard you said it’s could sitting be spread now, I'm correctly, ‘XX,

‘XX do than will the has So better quarter it you first historically? you look think think what -- of been the backlog

Joe Mara

Yes, so is R.K. This Joe.

the point, So of I I this and as we've kind think into quarter sense as part again, difficult half, it how we'll when But on things that. kind the think to exactly predict thinking a year, we seasonality. before. based way through. a are right quarter COVID healthcare at of And quite in a think kind first depends just the how well. about It's the think probably and I next I say to about conversations certainly guidance -- of is first from it’s I likely it's flow I say think what think seen quarter perspective on of would But really second of have would and get better it. those in cases and terms Certainly, perspective general first normalize I we

Swayampakula Ramakanth

Okay. Thanks Joe. for for that, you. question last One

during third catch among XXXX, impacting quarter up, we’re was million comment quarter? that it going the prepared said year-over-year what is so metrics. the this impact better there ‘XX, this was you the You -- on Can quarter catch-up could fourth $X a of into I during mean of so the

Joe Mara

the the can for you clarify repeat $X you can But about you’re So million asking question I you last know the me? just part? catch-up.

Swayampakula Ramakanth

was the What quarter there the was of in XXXX? fourth If some. catch-up

Joe Mara

that had it the XXXX to that, the of is third across of quarter impacting about of we the when saying we're No, metrics, third kind business, what that the the or recovery, when of you're quarter some looking across really third current at V-shaped was impact -- was, compare quarter that the which QX, comparison. year-over-year we impacting I think you XXXX, for that were revenues including results, of at XXXX, were talking looking when

it more XXXX. QX So of was about

Swayampakula Ramakanth

that. the any in you anomaly identified was Yes, have just if trying see to I I got fourth quarter XXXX? of

Nick Colangelo

Yes.

we slide year. last kind initial of winter year, Slide you a So have only saw gives what we in recovery R.K., the X, accompanying presentation but the in for this the spring our surge the it periods not on as over of

that the fourth drifted right? call schedule a December, February. wasn't We in part case mentioned answering of your of just difficult activity, the as of the that question have January the it And early into of sort they in we and on sort of have past. weeks our And might two didn't last quarter is, sort sort of

hey, kind quarters clean all have in of happened a the second XXXX. quarter didn't of you surge December So, say, it first to break in -- what of and ended the

given to expect to So, it's happen a us sort recapture degree are with of little in we Joe's I little they the quarters hard of and that it accuracy and of it think individual years. going But forward. hard decide this move to kind crossed to pinpoint want year, opine of patients first a the it's half that for when to to point,

Operator

from Cooley Your next question comes Chris Stephens. with

Chris Cooley

headwinds were additionally to you may, want But in know just I'm in favor use there. changes seen the COVID underlying of multiple physician some of shift, bias referring I quarter. single versus clinician a protocols, I the if If MACI and the we've in more briefly appreciate see curious, this shortfall that [HA]. specifically, touch on maybe practice to anything Fully

Danielle's behind quick prior in game, again, understand Thanks. and up. trying the XQ. if them seeing to perspective to pronounced? that the this think what's you're that these stage from might've of through just either any at XQ that a are patients, the or thinking fully like And subtleties a terms more just made have I this pulling staging in Because of curious question, make seasonality numbers the sure the I all we addressing way follow little physicians process the Just a bit about

Nick Colangelo

I'll start can of what from Thanks, kind of Yes. perspective, sort then a revisit the with and Chris. patient question. see seasonality we Joe physician, just

I things a and in And limit surgeries I as the two that perspective, that's is guess really physician One of kind the as of reflected around, of and/or what we've we dimensions on When up Delta to impacts. significant, As And continue of this that's pause sort were right? navigate really the is enthusiasm impact a surgeon biopsying kind And of, from sort any or think flaring seen to they variant surge. we mentioned, the to based. pretty I their see. Again, there physician institutional product, of that number have expect of institutions institution sort seen physician-based which growth for arguably to there is, some best were haven't issues at interest all MACI. least physician in either great. in parameter was elective know, COVID-XX

physician's So, that the as control well. is out of

quarter. patient even as of we I say, piece sort will our to was come sort with come anything May impact the I in general of do. our perspective like no as think the the of their from we will than from surveys and have they enthusiasm restrictions, key that behavior And referenced. and of early more behavior standpoint. think able struggled dynamics actually So, sort travel to as that, that sort patients they third I do out And the do have say talk have I want to and physician patient choices restrictions, get the And in leaders, opinion of sort it and dynamic other a is, of much patients finally the to of surgery, as were surgeon. when to to by people surgery dominated with things of

have And I launch great. uptake are that to that think seeing coming of from question, this kind still with enthusiasm, kind and of is, surgeons underlying you're surgeon among So you. agree since that XX perspective. it's Danielle's now premise X,XXX we’re it's which think of our into we continue surgeons the I a And think it's going remarkable to we great grow and year targets, given we

a our can outlook and mean going of for sort biopsies this year So add comment I'll Joe, And next on growth surgeons and you end there. what in forward?

Joe Mara

Yes.

about you’re from there, to think a and this with think underlying not think that XXXX question, just I of just we and earlier in the on and I drive growth the beyond. growth that referencing can the sure that. question seasonality certainly only answered continue to to We mix we Danielle drivers Chris talked I And earlier. the make bit think had, kind back

of historically terms look of it's of well it’s the back that if in in consistent as that you I at the to And in think guidance, mix XX%-plus been you quarter of kind MACI, on year. range fourth look pretty I similar If kind mean, business. the this

in I fourth even there's behavior into the we're still -- pre-COVID the just So, seeing physician seasonality a patient quarter. that and just perspective, uptake way of think and then from kind COVID,

So, patient that at the reimbursement future. end behaviors, that and certainly of that this point, I and seeing kind expect foreseeable kind dynamics physician the think, play just at seasonality the year, of still we're as of given as well still some of the the some of for

Chris Cooley

for that And Thanks hour additional just over me. that there. filing else be I Apologize now any to your next want if in now done But insight very we missed curious resubmission, around has just resubmission But again. gain anything this see additional briefly and for that if confidence now. provide I some NexoBrid gone on earlier. could color that targeted to between XXXX, time? just just mid-June has an year in if call curious the you there know could

Nick Colangelo

Yes, Chris. no worries,

FDA As about is, additional asked call, the there prior our on last NexoBrid needed X some really sort CMC potential of that we info. were One things to talked occur to for approval.

So, for additional into CMC a that resubmission. the in use CMC revised integrating process it in and MediWound, module providing we're the with obviously information

work kind package a so entails putting that So, of data, on. the of and generating it into

observations and do GCP inspections. we The we'll we and now conducting little Taiwan. they're the so restrictions issues at at FDA that's the ongoing time, those that know that in And upon issue GMC, premature the has related It's U.S. reviewed been referenced inspections CMC on a outside now inspections work and point. The But to that with inspection CMC spec Israel that And resubmission. continues. are discuss believe that, are their those FDA this also something occurring. FDA

place or And And questions. study a prior sites update then is process safety to we're the FDA's reviewing to the routine additional put of respond part in resubmission. being their as in to so at the will finally, be details of end

meeting were FDA those the how elements their with all Again to going had a to So on we X moving agreement plan respond questions. to productive are forward.

submitted And is our and assembled point, completed that package this at then by anticipation be now mid-year. resubmission and into being done and is work so will

Operator

we no queue I would turn And this over it to time. for in closing management at remarks. have other questions like to

Nick Colangelo

to thanks execute say challenges, to to everybody And the and well for your wanted the company in just questions continues COVID despite well, your year. Okay, continued overall. company interest throughout the the

expansion, We driven expect both by revenue mentioned, another cash year we growth, of margin as top-line flow, operating significant franchises. these of high growth

in innovative our strong portfolio believe for positioned given is financial large of profile, markets, company products the addressable So sustained growth. really we well long-term

So thanks again for your questions, and great day. have a

Operator

does conclude today's conference. This

disconnect You your lines. may now

Vericel (VCEL) 9 Nov 212021 Q3 Earnings call transcript