ORGO - Earnings call transcript Q4 2020 | Organogenesis Holdings Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Fourth Quarter 2020 Earnings Conference Call for Organogenesis Holdings, Inc. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded and that a recording will be available on the company's website for replay shortly.

Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risk and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A risk factors of the company's most recent annual and quarterly reports.

You are cautioned not to place undue reliance upon any forward-looking statements which speak only as of the date today.

of do commitment time the required to whether a voluntarily company time, forward-looking by may events, as no future undertakes update result applicable it securities so except to from the statements or laws. Although otherwise, information, as new or revise measures Generally call Principles Accepted This financial or also calculated not GAAP. references include are will Accounting in certain to that accordance with non-GAAP We financial to generally as measures. these refer presented in most on Reconciliations and of of comparable measures in available the non-GAAP the portion release with those measures accordance the financial to Relations our press are website. GAAP calculated earnings Investor would turn I the to Mr. to like call now over S. Gary Holdings' and Gillheeney, Executive Officer. President Sr., Organogenesis Chief Please go sir. ahead,

Gary Gillheeney

on Chief Organogenesis in Francisco, everyone and Thank a the fourth Financial you, Elmer. today joined to at Holdings our joins was and by long role Officer Dave the XXXX career appointed to Perkin earnings who new quarter after welcome us call February conference I'm call.

So our operating growth of let I'll an our me start the impressive questions. financial afternoon's operating then cover you a the open press with and revenue share the out included in review team and key performance the a remarks. of our more my our we despite fourth XXXX overview delivered for of will prepared provide results will brief for then today of in-depth drivers review fourth highlights quarterly with release. of quarter the we'll our a after in our agenda in in Dave challenging of formal start up year-to-date periods. that we'll remarks, review what and I quarter And guidance And that with the a brief in environment.

surgical quarter year-over-year in our and the the in brief compared products review our of begin revenue and sales growth to sale XX% total quarter advanced reported with fourth the me revenue prior products XX% wound fourth in growth driven sports Let XX% growth medicine of year. performance. by our of of We a care

and exceeded revenue on our Our January revenue preliminary results range were of end high above the guidance our announced well XX.

products growth each the drivers of Our on investments earnings competitive portfolio new years, process, the QX our of calls of about advantages recent focused of to healing across of growth two and in strategy we've patient our of that product products continuation channels, that to years talked address execution including expand our over a commercial strong comprehensive and in sales and needs the strategy our multiple made last we've our treat the force key the brand introductions that benefits our stages in of the all loyalty. wounds leveraging on the reflected

of QX. a share more on longer-term the drivers strong of to how these contributed little growth performance me color in Let each

at representatives investments XX% as to sales of made sales direct of of direct we've to For a our significant sales representatives of recent us, team XXXX. compared end reps last the years. XXXX CAGR result, this XXXX, increase a year-over-year. grow that's we've investment increased in We the of And XX% the ended number end an over And have at of three XXX with prioritized the direct since of area XXX years.

over this investment year made our the quarter benefited team fourth Our results and revenue clearly direct several grow last fiscal from commercial to that we've years.

in development the fruit. pipeline specialties, We've broaden a physician to PuraPly focused team PuraPly XX% research in performance And reach that delivered our new better the of to number the and assumed in headwinds related guidance leveraging QX. care, XXXX to the pricing sales team's result of the fourth anticipated our revenue of of product rate decline the approximately to our implied there's growth expanding a this year-over-year which example quarter of XX% multiple well ahead on strategy as for of sales calls bear Second, than increase the the X, the outpatient our bundle change no success the year-over-year for executing in the increased which status XXXX. introductions. impacted product in only impressive into PuraPly sold setting October and products PuraPly our high-cost sale reimbursement transitioned on of been products. strategy continue into change in new the This to sites

sites in the at improvement positioned and in PuraPly in additional was PuraPly aided do continue of additional Clinicians XXXX. continue past. product of and years launched of in our that sales any this QX number be better utilizing line strong quarter. additional QX. were These all of We four product five strategy value it point the An the are what drive of of accounts the in proud time XXXX to part the largest to PuraPly just to to overstated. of years. over the new we were years can't to marketplace amniotic this five new QX. area strong navigate care, product were and we contributed in two in The the to can our awareness pass-through reflects discussing execution overall in of see pass in contributed clinical the a third sales the of differentiation the strength sales the company's we believe off is a notable data, physician important the of last part strong two to investment ability in growth with PuraPly coming and of We've the the and extensions with today strategy performance the again through community brand product the of launched amniotic status as growth in introduced differently results the QX. we've in the products Sales been than fourth the loss specialty by PuraPly last over it PuraPly which positioned line extensions products grow

several CPN's XXXX. September the office in our for of continuation the on growth our leveraging we've accelerates years primarily offering CPN strength. access throughout a in the Bioscience. the management growth physician the with It's recently channel and discussed broadens for fourth past penetrate opportunity our primarily of and offerings what strategy calls acquired area more Our to working market specific product provides, been office of is notable office that physician further acquisition solution in We office which our channel. this CPN We've

we more to way operating environment see of during of the outside Surgical fourth ahead of that benefited trauma this our you metropolitan from pandemic. an mix better-than-expected well in the challenging By experienced large the the by companies of continue Finally, sales relative our in we areas impact to related QX, have compared resilient Medicine our other wave market. our been reminder Medicine & overall that fueled have see year-over-year Sports the pockets elective quarter in the respect of targeting continue guidance & Sports results sales physician we products increased business areas, didn't sales QX, made U.S. because the and the first Surgical trends improving strength progress as to pandemic areas growth to we XX% as more which was With of expectations. specialties, procedures to as which the in extremities of related of more the well experience trends headwinds and that to as including COVID early new major COVID of

financial channel non-metropolitan impact to the headwinds we areas So second summary, despite hit which less operating and also pleased in to side in specifically has resulted outpatient exposure COVID diversification wave growth XX% by strategy profitability are product an generating very we despite positive just broader sales million the years the see our by continued of to year. this in and in And channel our mix our commercial to the surgical challenging office the business operating our we in growth past revenue from pandemic environment. continued of contributed experienced that the including our guidance the as were where care the we those fortunate to GAAP the come. inside settings our as our of reported with income business. having evidenced significant These seen in physician care underlying of In ranges all QX sports have performance net - adjusted potential continue reflect were ahead in in profitability But XX% quarter. business on results we've the medicine by and specialty of has improvement margins, our mix of revenue $XX in EBITDA by pleased the our fourth this the quarter, with trends in acute were of the product and we well

years. several been financial in discussing we milestones proud advance these community we achieved Importantly, that targets period of profitability financial important the with we've the well over the last stated interim are

million quarter. also a $XX our portion forward. offering, our which in operations to of with the strong And proceeds of $XX our We from in we than $XX down We raised condition the initiatives generated strengthened leaves net the period, stock, in million on our half public credit our million XXXX improvement than flow common of underwritten to balance QX, line quarter the pay along well ended $XX borrowings of with going more growth the us generated an The with financial flow operations the from we proceeds. sheet cash further of approximately offering in million common stock cash execute more net capitalized during used we and of from of cash. fourth material second during strategic

operating brief of review to Turning a our highlights. recent

OA but efficacy to our FDA review the potential the the sheet and balance are Securing recent significant as we a potential to RMAT Therapy over key amniotic to we our symptoms press officer, with of short. our In evaluating results of announced approval pivotal Advanced of a Regenerative a only the ReNu study announcements year for is of look that we evidence trial, therapy financial for clinical our Together management addition closely the our designation, call associated designation as leveraging for also important existing impact introduced of cryopreserved this made to first January BLA need. accelerated announced this me for with or and in the potential the end the and or of On enrolled the status. Francisco, knee clinical January RMAT Medicine designation and the our safety not underscores largely suspension of On of including had that its David ways potential medical our XX, revenue osteoarthritis, in patient been new release. Dave? RMAT with us review and forward with associated months, fourth ReNu designation III regulatory ReNu XX, the license. RMAT that quarter, osteoarthritis for of FDA address symptoms to We management financial our regulatory knee the in with priority progresses. the for clinical the appointment to the ReNu, financial knee work both of of chief David granted to turn of a the allograft XXXX afternoon's ReNu the have advantages for provides expedite strength milestone and which this ReNu OA. let Phase underscores of guidance that, With review condition the our we review unmet of for support

Dave Francisco

million fourth million fourth XX%. compared year-over-year was a Wound last Revenue review a Gary. $XX.X an Revenue XXXX basis. was million year, million $XX.X million increase $XX.X Revenue last referenced of to million from of compared products products $XX.X an fourth-quarter the fourth or $XX.X XXXX XX%. otherwise are to an our products fourth growth of Care results. revenue begin of - of million million Medicine my financial or compared to PuraPly XX%. was $X.X Advanced year, Surgical of million the and increase for was million $XX.X $X.X remarks quarter an of XX%. prepared our $XX.X from with quarter $XX.X of XXXX for the million increase XXXX & rates increase last or Unless of for you, the quarter from Net I'll $XX.X during year, last sports Sports or million revenue all $XXX.X compared on to specified, year, Thank quarter of for

gross increase to increased for to over points agencies and December at well profit sales costs quarter and products XXX revenue million driven as increase Medicine due the independent XXX general of resulted increase administrative commercialized certain by in the costs compared sales to of of & products. manufacturer, the million last in increase a the expenses our year, year-over-year an costs of an $X.X XXX of XXXX. $XX.X in year, of the approximately yet XXXX, compared fourth an costs was XXXX last the our XX%. margin count, fourth profit sales Gross product was representatives strength general expense of to XX% approximately in administrative development XXXX XXXX, in Surgical end R&D to expenses our in due million associated products processing from an approvals $X.X in selling, increase the a $XX increase our increase operating year, XXXX and million selling to XXXX $XX increase year-end was increase million in XX% well direct increase last as volume we expenses in margin compared or XXX year. sales driven Advanced million increase $XX.X commissions sales including our an at in not compared $X.X and research as Care As The clinical had direct and in and year-over-year with pipeline were of to the The driven XXX compared force, royalties. card million regulatory increased a quarter XX, fourth Operating The in and for shift study X%. $XX.X primarily period. was head fees basis for year quarter and as Sports associated in to fourth costs, contract Gross Wound product gross an to to or in The primarily by of additional of process was for expenses mix seek year of development million investments increase and new higher products. credit prior compared quarter by and other necessary increased related with

to the included fourth-quarter quarter activities. an fourth year. $XX.X restructuring EBITDA other a a an prior XXXX benefit million our related $XX.X $X.X the or $XX.X net There year, to last was last a the restructuring Additionally, loss prior related year, The operating $XX.X $X.XX increase million was retention compared compared million. of due fourth for increase for $X.XX of the and no to expense share primarily restructuring million year, credit million increase increased representing income million expenses, Adjusted were million $X.X $X.X increase of costs $X.XX or XXXX in or million or million expenses to $X.X of million Net agreement margin the higher expenses sales, average a quarter the $X.X the Fourth-quarter quarter interest of XXXX specifically a margin percentage employee XX%. company's was fourth $XX.X to from of to million income the of resulting EBITDA Operating XXXX loss expenses was million share. points. improvement outstanding adjusted to million. XX% of Total increase was were $XX.X year. compared fourth year, an operating for for XX quarter an operating last year-over-year borrowings compared other of $X.X last an compared of share in of under $X.X of of of XXXX

have earnings full XX-K, filed with release, SEC in We of Form this of provided afternoon. Form all our and the adjusted X-K a EBITDA our were which reconciliation results

Net for XXXX or our of XXXX driven for the up the year net full-year a points. XX%. in Net last for increase Gross million $X.X full-year $X.XX Wound X%, loss million the months XXXX the $XXX full-year financial $XXX.X our and to million period. XXXX to $XX.X Sports basis XXXX a for revenue million & we period million $XX.X percentage net XX% to compared compared $XX.X reported loss $XX.X $XXX.X margins X%, was And $XX.X last revenue revenue of share period $XX.X last net the XXXX share review Surgical margin was in was XX brief a of over EBITDA XX% loss XX%. or Care for was of to the to full-year December than million of last million in year. as XX period year, million $X.XX of a period year. XX, by year for The or Net million full-year products of year, ended products $XX.X adjusted increase last compared million compared more XX%, compared the income was of or increase products. XXX XXXX. Turning of Medicine a to points net XXXX was operating increase to a increase, PuraPly revenue revenue an an or results an year, of the compared EBITDA Advanced Adjusted million increase, period or million full-year over $XXX.X for full-year operating

Now turning to the balance sheet.

of provided by the $XX.X increased activities. XXXX, As of million in obligations were and million of capacity and borrowing $X.X million XX, lease million by cash was of lease by million million $XX.X $XX.X capital financing XXXX. borrowing provided available million capital cash, Net $XXX.X in which by obligations. as obligations, in capacity $XX.X million and of $XX.X in approximately full-year XX, operating driven investing cash were XXXX Compared the $X million and total $XX.X of December million $XX company debt total available approximately which for in obligations, $XX.X activities used of period cash $XX.X million partially debt December had activities, million of offset cash, to

guidance. a XXXX our revenue of Turning review now to

XX, of net XX, December increase to As to we million year XXXX. representing detailed to $XXX compared ranges fiscal and of the net XX, net XXXX Net revenue million of as Surgical compared revenue $XXX representing months Medicine million of $XXX year XX million, XX% revenue million million the PuraPly products & for months year guidance our $XXX over XX% $XXX $XX months Net introduced XXXX expects year million this XX afternoon, ended XX Advanced net compared the of XX press between of from $XX between million flat million year year and sale as $XXX.X approximately XXXX. XXXX. for XX% $XXX decrease XXXX. for XX Care Wound revenue XXXX. in XX, decrease of a an The XX% December products year our approximately assumes The December XX% December to ending to approximately to release year the ended an revenue a between of million of the net months and representing revenue year products Sports over revenue our XX, compared approximately of $XXX.X ended company months of over revenue over as for between and $XXX.X revenue to of net increase net revenue million, representing ended December for XX% from X% to $XX.X from of million, guidance

revenue addition for expectations for our investment when we for revenue investors intended evaluating provide to few in the would year growth bear a to mind fiscal understand our community to color the to is the supporting assumptions formal help like guidance, In expectations This better considerations XXXX. additional XXXX.

our our amniotic XX% year to full-year the midpoint of contributor be of year XXXX. in over revenue First, fiscal growth sales growth of range, our company assumes at amniotic year will the in largest approximately which, products, net XXXX total

over which midpoint non-amniotic group XX our me, collectively excuse form non-PuraPly the approximately year in the of increase XX% products, called at the Second, to range, and - we XXXX. other, year of PMA expect sales

headwinds in to we we improvement move steady see Third, XXXX. expect COVID-related through as

the first relates assumption the year guidance growth compared This XXXX, an in for stronger primarily as of two growth to the the is XXXX. to to the XXXX. reflects of for for guidance our our what guidance other year-over-year by reflects XXXX One half half second However, driven full in in factors. relates

we XXXX, XXXX. the Advanced over in to expect second see - the XXXX Care the strong growth, we the half lap business in moderate Specifically, as given growth XX% over of our the reported Wound year-over-year second we of in half performance trends

headwind expect we business, is of our XXXX & under Sports Surgical our the a existing & sales of assumes on an HCT/P, half the scheduled May to in expiration to the Medicine occur to in second for in our operating While guidance of growth business trends XXXX. significant environment to Sports Medicine products Surgical XXXX regulatory benefit grace period enforcement FDA's XX, Section related for criteria the XXX revenue which

of ReNu ability this Importantly, we XXXX our approval, continued elected ReNu BLA a to no represents of clarity contribution applies the over products issue additional believe seven guidance headwind approximately This receiving assuming $XX growth and NuCel on in X, million. and we only products. sell beginning have last NuCel advance to our to of months the sales June from the these products to of XXXX. XXXX Pending

and Finally, to with year financial XXXX, to GAAP we in expectations performance fiscal report for EBITDA period. respect expect adjusted positive income of around XXXX net the full

In financial - for guidance addition me. addition excuse in to - to XXXX formal our sorry, our

considerations are We providing purposes. modeling for some

million; period, we the operating expenses operating expenses; XXXX year gross margins of GAAP inclusive to noncash normalization and approximately For turn of stock With and XX%; you. XX% other a diluted million; shares approximately million; year, operator, increase and weighted $X of $X over back $X to the total that, of investments growth comp of approximately approximately total approximately GAAP approximately of interest expenses it XXXX million the noncash shares. average full-year of expect D&A I'll XXX

Operator

first Miksic from our come Suisse. you, will question And sir. [Operator Credit Thank Instructions] from Matt

Your line is now open.

Matthew Miksic

much taking good evening. Thanks guys for Hey, so questions. the

a really focus here things on it's see to great to lot And in mostly kind of direction. about much a on to talk that - happening right we're, on the strong working of things good in congrats and I'll focus finish couple. that on here again really, just moving So seeing

a maybe little if talk could bit about. So, you

other And round growth terms of as provide on color comes on numbers us directionally in how XX% what of magnitude the the of businesses some this have like what And look give that like growth office. in just appreciate sort any by deliver sense of a then could major or maybe physician's to similar I one You think If channels - of about of XX%. for you maybe care runway looks a together to and growth to types the this you color follow-up? XXXX? all

Gary Gillheeney

Thanks comments. question Matt. appreciate thanks, and the your for Sure,

we direct don't really sales provide on guidance So, channel.

stated to office reemerge nicely growth We to in in wound goals XX% Our but for some that do the half setting. see was about expect advanced starting revenue care of we're the our quite the to of strong we second year. be and in moving see do towards demand at goal, the the office in outpatient the

So ankle and our what trauma, where significant more part the for year, in that medicine going foot medicine and unit And be sports a where which Surgical more regenerative in area, was interesting the so have of the the business our in and even have that's us we'll channel in QX even helpful of than technologies we additional and the which also growth spine - we exciting also frankly, areas HOPD is what road extremity the our is & sales the but in QX Sports surgery Medicine. sold to quite down for in mostly in call office. be revenue surgical the can more

more particularly the gives with customers which are perspective, us and now of of be CPN, areas looking acquisition little certainly our a growth us - growth more a access from office to but that will all the a right strong in channel. component positive those those more of entrenches of So

Matthew Miksic

strong on in around I'd some and second one sure and question That's very half other I'm you growth half I'm back margins. folks have contributor EBITDA you to a was could sure obviously just strong the those to EBITDA. ask line if trends a delivered very great, mentioned. I that XX% topics follow-up XX%, and But - if And just the of sort top of

full half positive to think mentioned in half can either or other give you to front You've that about any back how year color us expectations? EBITDA XXXX, as

David Francisco

not QX saw so back by breaking the very, Yes, fourth the in growth of XX% will year quarter, we absolutely the What but XX% we're right. it quarter. you're say strong was I down in very half and

that So through. obviously growth flow lot generated it of a

And give guidance down so will go we components on some key to EBITDA. you the net expectation, our that to income tried and

know is hopefully a so, we've in out growth you There sure as there step-up the was - But some for to we have indication well. helped And investments it there. is to big build models. wanted be that your year

So, expectation we clinical to well. a commercial to in big around have expecting the invest expenses continue spend are around as resources and

there XX% we think faster half. there's we long-term EBITDA, that for on that but opportunity anticipated in think the So, I growth little back got a we based just

Matthew Miksic

of up, the on If - right I next up back half? front spend back could continued comps you're and here pop way just the Is half in here the as you expenses front half, about as obviously sort growth ask, quite maybe some is then tougher as you way maybe half catches is leverage see back And catch mean year. we to that investment not front facing saw momentum in of mentioned of as the and strong maybe, the it right half? think to to, about much, think that

David Francisco

the Yes, don't again would of I that first around But comps mean that want guidance given half say back year the your in point. expectations saw correct from are I we we half. I be the growth think comps last the at versus to quarterly this providing

Matthew Miksic

Thank Dave. Thank you, Gary. you, Fair enough.

Gary Gillheeney

Matt. you, Thank

Operator

Thank you.

Zimmerman of line comes question the from from next BTIG. Our Ryan

open. Your line now is

Ryan Zimmerman

Good of the Great, thank for you. taking performance the Dave. Good environment. XXXX Gary. in Thanks afternoon afternoon spite questions, in really masterful

you appreciate for that mean the question quarter? PuraPly in think in of guidance. of guess this spite I And digit taking are volume kind in think the when the we I extensions is is unit I the many and thoughts around get Gary changes mid-single just did big guidance about the I the of of So, the around you you around to that and but line in what spite asking of range kind grow the gave, fourth reimbursement particularly are kind and all your color growth do year place? what maybe could expectation

Gary Gillheeney

Well, sure.

So strongest benefited some obviously quarter was and I manufacturing. our think and from our really QX performance PuraPly of generally QX which amnion is disruption strong we our had in the

a it's So comp. tough

for expect we with do PuraPly. sure forward, Going growth unit

We into relating for the to have headwind our pieces. months of going three larger bundle

headwinds some is there So there. ASP

do we've to additional do our we'll overcome additional extensions So we'll and got products. with five headwinds, it volumes. line Well, new those with new it

sort and of unit growth will ASP that off very, last us. quarter see strong of So, still coming pass-through help any overcome. The year offset the normally for decline was fourth very would we

as So, there a be have to we that comp well overcome. that would in

So to performance, confident PuraPly we well now pretty slightly four know good If they're launched nicely. guidance. in think they in you is do the with its products keeping to Right continue early trending collectively we down we'll that flat days we, QX. but be

Ryan Zimmerman

as far potentially a of And what go back Okay. that take guidance just see to it range I us half, or be? that before maybe but of as conservatism particularly the the potential the result outcomes for that of XXXX, maybe outcomes out into will appreciate in understand we the that? could about discretion, the could we range help of hear as enforcement would effect

Gary Gillheeney

off So I the first number the so the important directed, product will we not unless take one market thing. that's think

selling the of have directly the you license. the FDA, as a BLA no not and requiring keep FDA think an to give but they're cannot to expert these I'm FDA I authority products in all

take. have yes, don't the can mechanism can't, they that can an for off market, think they certainly certainly to actually say there's can stay action I them market. a on you, you the tell you that's So They come to

managing through this where they the selective enforcement So, see enforcement risk. we they're think and

think can you get says going with to So the that letter on authority I that I anybody a market, don't don't as the is believe FDA. stay exists

where I think process the which product not We'll you'll safety of product the process. enforcement on and of or is whether IND or under the are the is arm. fall likelihood based you that risks the BLA in dictate the profile

and clarity monitoring off. on the on can it's you then enforcement not yes So to managing get activity. great there's you yes And only have just unfortunately, stay

Ryan Zimmerman

Okay.

Gary Gillheeney

and requires they're and requested believe - We meeting all that to we from we meeting type have confirmation products. within XX days. try a us meeting which more them FDA is, more on understanding meet to And our don't it's how a get the C have frankly, clarity haven't with viewing of to when I quite products

hopefully them, leave there we that won't stay So, with when will on. a verbal we meet says with but you some can letter we get clarity, - more

Ryan Zimmerman

Okay got it, helpful. very

Gary Gillheeney

clear. Hopefully that was

Ryan Zimmerman

think could well? relates And as you place and the data - that hear squeeze - on where And appreciate No, could I at are understand the have a for broadly last on remind process that. you clinical impacts But if picture, of very us from potentially you. BLA. enforcement - the it then in reimbursement helpful. discretion I in year proper when renew with - can bigger as do some are you we market renew Thank to updates potential the one more in, kind this where we

Gary Gillheeney

Sure.

first So, we half the expect in to the complete of XXXX. enrollment

the have it to approval review extend it it right to then a that probably implies nine would this deemed for but out to expect XX FDA XX-month XXXX we're months, on one our trial only second takes trial XXXX and to the having submit half if to XXXX. complete out which do that a assumes in in the schedule We And XXXX that have at obviously based least and first our now. do year time FDA could we a a of then with that filing study you that

Ryan Zimmerman

it. Got questions. taking the Thanks for

Gary Gillheeney

Sure you. Ryan. Thank

Operator

you. Thank

from SVB Leerink. comes question Newitter line from of next the Richard Our

line is open. now Your

Richard Newitter

the taking the Gary, congrats the David. guys challenging you for through and way Thanks year question the did on managing Hi.

Gary Gillheeney

you. Thank

Richard Newitter

moving in follow-up one an you demand update on able me - the So this quarter how first give the has the two on you are supply that affinity just maybe us would demand your all ability you that a then marketplace affinity that's to ReNu and you've and one as on to of with year? about said that through product. we the or the capacity where there? Can on should be in the past from the thinking manufacturing satisfy starting Are outstripped Gary

Gary Gillheeney

Sure.

didn't is improvement it hoping We increase support of our able demand year. all earlier. come today. get So the existing to the That the did QX not end capacity answer in last We capacity to December. were we're until of

that probably and capacity, enjoying are we of level QX we timeframe. in additional of getting capacity this process next whereas year April-May until that the So the in to won't see

So we'll start second to see some improvement in quarter. capacity in the

get had to XXXX. in the times is capacity goal Our we to X.X

second of the the We expect year. to that in half happen

half of get till the So year. we there the second won't

we the think to even goal. So strong around country, product times that demand. at need And is demand to think X.X above make times believe we'll to the a we the in we start XXXX. grow. that as going forward continue dent to But continue we will get in X.X the introduce capacity We that our

Richard Newitter

And trial we said the for it. one, track, data ReNu, what on Phase that I then hear still about expecting, on in hear you're you that, think that about is form? how have past Got will that XX-month X the we readout in will

Gary Gillheeney

if was study. the That talking you're XXX-patient published, about study XXX-patient

Richard Newitter

Yes.

Gary Gillheeney

Yes.

Richard Newitter

With the that XXXX to data going the or we data? what are - - in Phase expecting okay additional any XX months that so from X

Gary Gillheeney

Sure.

just data published. as XX-month was it six-month data published the already know you was the Obviously recently recently. just So

published. the was So recently data XX-month just

the We data the expect know this our interim end by of analysis year. trial interim a to patients you the the of QX to close readout of X Phase next of getting the of of have probably completing XX% in would year

XX% interim of the study interim next at dates year those the XXX-patient of our and of So of key publication data XX-month the or this the our The data in QX point. are study. study six-month pivotal of readout then

Richard Newitter

the you review. you. you opportunity either about us what helpful. that's just it? And Okay thinking Can you you're available Thank once way on market market would the the be think help I'm target can way size us help there? the would and through potentially commercialize have And opportunity

Gary Gillheeney

today $X.X market a hyaluronic billion market. the see acid being primarily about of we which So is

and you to demonstrated just leaders. the we've it market published And comparing as that completed and hyaluronic obviously of a leaders superiority study we one market was one months XXX-patient XX and our study acid. three-arm So of to six just at the was mentioned the one XX-month data

the compete that with of significant today reimbursement and of very that we that space approval think would a we well larger market in at share the space. with some So in that competitors and would have hyaluronic acid

if, for products subsequently large So potential market reimbursed. large approved the and if

Richard Newitter

thanks very Thank Got helpful. you. it

Gary Gillheeney

Sure Rich. you. Thank

Operator

[Operator comes from Instructions] Steven Our & next Oppenheimer Company. from line Lichtman of question

now open. is line Your

Steven Lichtman

business. I amnion XXXX The for on for Thank know know ask you want today? to congratulations. expansion itself. a you I'm overall wondering feeling efforts guidance just the competitively the guys you're strong the you. how in again use Hi, are speaks on you given and what seeing marketplace, the and seeing to about significant that of relative in competitive are amnions talked we also you guide

Gary Gillheeney

an technology that continues Well, we we space certainly of and in technology medicine skin even see in growth that expansion amnion the largest to same business. sports be surgical see our in growth the biologic the subspace auto

So the expanding market clearly amnions growing. are and

unique. so the living only bit in it's Our amnion product the space, a is Affinity

is efficacy challenging know well. we're from a any the that's hearing from product for strong competitor product don't perspective. technology the the that a So see from as field perspective, really it there very we you out And

that. So we really about good feel

as just generally companies know think to and seeing you continue you're activity that of expand the the competitive I will I think some from well. more amniotic space

Steven Lichtman

I as and amnion what NovaCor the about portfolio? expectations pipeline, you to that a your then talk if just this, And a for missed can bit but adds there it. little on follow-up Got more apologies

Gary Gillheeney

will that that year, of impact It's constraints don't material. Affinity, product And that to Its year will take most the we We're NovaCor. it so believe for this Affinity make same efficient be makes product it's for that the be remind us. to significant manufacturer very away processing a we part capacity capacity till NovaCor's basically would product because to or NovaCor end creating of to have of will this because any you're XXXX. us. from everyone to create We won't time the process way Affinity make expecting be be significant it revenue any the amnion. impact launch this with year just the not a at want But the

So it but in it perspective, opportunities. we end year. will unique sites launch do we the growth it And issue only it And that's the we will multiple have additional a launch living of product. manufacturing care, of is the be Chorion give from product to we that think a expect also which at might

of more to for somewhat some wounds. have the it in In greater which ways properties has types make itself certain addition useful product different and utility

Steven Lichtman

Great, thanks Gary.

Operator

you. Thank

At remaining participation. you your this time, We queue. showing currently today. conference conclude no Thank does our are the in for that questions for

Gary Gillheeney

Thank you.

Organogenesis (ORGO) 17 Mar 212020 Q4 Earnings call transcript