ESTA - Earnings call 3 2023 | Establishment Labs Holdings Inc.

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Operator

Good afternoon. Welcome to Establishment Labs Third Quarter, 2023 Earnings Call. At this time, all participants will be in a listen-only mode. At the end of this call, we will open the line for questions and answer session and instructions will follow at that time.

As a reminder, today's call is being recorded. the to turn Financial Denhoy, now Officer. will call Raj over Chief I go Please ahead.

Rajbir Denhoy

and everyone, Chief thank With operator, you, Thank you, is Chacon me for Juan Quiros, Officer. our Executive today us. joining

remarks, prepared questions. take Following our we'll your

for financial Before plans laws. that made development we based on These product will forward-looking include by you meaning and the Labs' call comments statements this statements and begin, within expectations forward-looking like outlook during uncertainties. of sales.These remind company's statements would management's include on I timing and and to the management risks federal involve and Established securities are current

investigational after For a also of the call. in Form conference FDA is to the this to at well obligation seek of statements call encourage Juan XX-Q established a call States. a reflect review approved. on our cause that or the otherwise this Please as turn any contains our local actual our our is information and continually approval it uncertainties required check date expand and to geographies of X, products by XXXX. discussion time-sensitive on to to results and Form date only my with to other clinical undertakes availability.The live law, this product circumstances authority revise received which or We most in to XX-K recent you website the are United as establishment and or to of that, exemption Jose. annual as from pleasure available undergoing cost regulatory broadcast, of quarterly SEC for November I over principal trial which no support accurate Except specific factors differ that reports as affect note Labs Motiva statements. CEO, are performance With risk events update the may Implants our device regulatory from the materially establishmentlabs.com.Please filings, the these labs for the

Juan Jose Quiros

Revenue XXXX good third XXXX. and third million, Raj, of quarter the in in afternoon, quarter you, $XX.X Thank everyone. line with of the totaled

this approval in seems it world. slowdown than we year. fairly the implant months our by in around in year Our note this year, for reduction this less was we China $XXX across over remaining would from reflected to as guidance full this to our the not breast slower quarter.As of accounts end to even and our million, industry. gain demand and quarter developed direct will The X% also trend annual our demand of are the reflected and our persist period, distributors, received in a the meaningful X in results portion this This still procedures removed we does of is growth markets the we continue lowering broad we while to in guidance.However, specific from expect we approximately seem fourth This XXXX. representing quarter lower have globally. in breast have related over such, aesthetics be we I orders expect that anything guidance

suggests and a are both is global sure While a our are seen and steps for and business expenses. procedure to reduction noticeable first headcount experience very relatively short-lived.That the operating are President spending in a have be a anecdotal, environment, to course, to careful in transitory said, steps the we in current we relation both dermatologists and not in Among their industry, plastic practices this in both make in international that being across demand. and this the taken reduction we report us, they and slowdown types, markets, will surgeons our surgical aesthetics of have and This all is, nonsurgical. taking

to the our United United levels.Even prioritizing into steps, China. well XXXX, through as our States States, expect and also we take our as global entry growth includes TAM initiatives, our these in main are we inventory EMEA China cautiously We resume and managing as which growth doubling

to in also are advantage sizable presents positioning share.Our that we a implants, data that is Our this a in gain capital shows industry. to inevitably for advantage significant markets internal here, grow to has surgeon demand is we been as and continue There continue note competitive our our access positioning opportunity. competitive is and take It accounts the worldwide returns important market to our to dislocation markets we strengthening. to our and ourselves breast

taking continue XXXX. are remainder of globally, should XXXX market and this into the through We share and

returning of contracture women for the The MRI Flora of requiring the a or the at procedure some key most highly available the proportionate intervention among choice.In we are breast all by was opening X plastic in other is on and advantage we Leading raising to Lisbon, help technologies a these With improve the was a of who feasibility during to Langer, breast and subject priority. and market. Mayor Flora study. IRB-approved the proud business our invasive services.Flora the in Implants breast that countries SmoothSilk to the surgeons available of Mia expanders they products publications and the list this encouraging. their that to from study. outside implant what is solid cancer, remaining years the prospective Despite in third and Motiva support and other Surgeons we Ergonomic expect milestone the subjects Flora in for and surgeon corporate abbreviation the developing The as aesthetics. proprietary innovation MIA the U.S. to offer This and ruptures. of the of nature natural who a further our throughout in of most requires to include the as of commercially devices study the was Labs tissue option, Flora SmoothSilk These FDA's approval, women on magnet should letter able was overcomes to between announced been This our are also meeting at extremely This X-year several implantable improved paper and within XX has of receive new no any and October to that have reports that for choose, at innovative Mia, continues our in United shown shape reflected oncology need noted. new distinct surgeons technology are anesthesia.The the decades. several the the add showed comfort of an like is XXXX to There industry.Our biocompatible are Plastic States.Flora World we X-year and first goals additional Flora analysis preliminary the are the reports also cup and augmentation, tissue October, U.S. where X unique are can standard on the and December by no Kaplan ruptures.A the by general the that at of indicated that with category have United be the medical major quarter Flora independent solution surface that an flow first the top a I MIA EBITDA in XXX(k) on to On breast planning the XXXX positive procedure performance innovations, the The discussing held without improved XXXX.These includes utmost Raj new little geographic of same including highlights with activities our expanders With XXXX, of result. be X women MIT XXX minimally the caused in Austin clearance very treatment many traditional months to study positive XXXX device. being shown technology. the surgeons granted adopt to by we are cash have the are annual but is we clinical the end seroma implantable an no downtime tissue published day entirely notable offers Fluor study plastic Society reception Establishment compared providing there of momentum, technology RFID-enabled providing approved of results a as discrete and surface pipeline FDA of minimal a surgeons Among our begin it engineering April SmoothSilk better outlook we the to they group the company for in patient with breast introduce new other breast magnets.In of in October, Portugal. beyond. bleeding, plastic MEAs the expander. for by hematoma of can that was will States States.We capture and foundation XX, in which a we and breast is Flora, expanders from in women interference being in the provide fuel will eighth with XX an have in We from moment, seen no compared and of at would of is tissue subjects landmark outcomes. conditional in were players are gaining of United markets are to devices build ourselves aesthetics.Our not America highlight grow. a enrolled women and patented on details results expect the a precision free, events, an American best the began avoids in treatment. imaging labeled to magnets Femtech up at available radiation women presentation other to traction and nonmagnetic Expander result end X X agency and imaging institutions Flora by obstacles XX-minute whole There underwent port Symposium will Bob MR as sub since we been available Flora highlighting which to is were FDA XXXX. Scientists, MR for

contribution Joka how decision. have can to MIA and paying only from $XX,XXX It partnered Japan, without unanimous we in points Federation, launch to her World procedure excess MIA, flight early international by those eventually proof is these our a is demonstrate average she aesthetics, firmly seeing also Boxing is France, we are according lives procedure. Boxing a of platform this and now just is have this is going that athlete consumer Joka new to some is be world the pay. of breast Jokastavayea. She weekend, launch which with in like the the implants or category.One mini total partner MIA Sweden, twice ergonomics for defended generation both regions consumers' organization, certified and defended Thus, more lead new our the opportunity of past include MIA, to abroad. a limitation the the our a the for just Middle with receive a MIA we to that MIA is return than in are months procedures distributors premium see world-class cases, and more place XXXX. Rica X, converted sites opening restrictions.Already, her as but begin testament to Turkey they glad capturing twice quickly inspiration is price is a in we clinics. her boxer, has since an of ergonomics to sites JOY only with titles are We beginning revenue at an Spain, of like aspirational.The be rounded way States. titles professional gross pricing.We exceed the MIA internationally United and the but creating not This augmentation revenue to we female new of highly taking to United grow. continue technology In to to blended and States more not East and category flying momentum JOY their into have women the are selling breast that in and margins but cost this our build women from contribution to in in of for continues Stories our our this MIA are price see XX% in experience. luxury program average positive the of will infant The than awareness now category to platform. This partner double reports in an to recent Germany, Switzerland, and Costa for willingness demand total

improve international prices world and and markets. MIA and margins As margins. States significantly The in will ASP scale, United in to highest have ASP gross JOY be the and accretive the gross China the would

the All a of very for this together strong foundation lays company.

sharing are We the same facility. as We we in in technology, the Pension of FDA U.S. XX the This launching under Motiva to launch with with growing quickly aesthetic same recent the Elizabeth XXXX, the full of coming forward under NMPA brings and with the our for is We finalizing recently very from first years lead approval positive. review interactions similar progress our wait our approval letter of brands. plans and She's remains of to of the the the about look conditions hired for implants. distribution agency.The are over of PMA at China remains you while more module share technology final launch. the In the and are months. moving of to approval surface activity for actively is and PMA out the agency notable separate quarter by of It the over RFID teams commercial the that preparing to the partner operational devices experience the and same and pace Flora Motiva and manufactured our the was for processes, business. the Motiva submitted build U.S., our

to to United continues the States women implants Motiva over turn will I will in available that now to call grow. soon be Raj. confidence the Our

Rajbir Denhoy

of which and X%; in you, Juan From Asia were and Brazil, of revenue quarterly quarter up single implant Middle X.X%. XX% third while $XX.X Thank total Europe, Direct was of America, Latin total, Africa market is the distributors were Total Jose. growth global sales XX%. East XX% which was approximately our regional was globally, accounted for the of sales. approximately largest million, perspective, a XX% made Pacific sales, sales approximately balance. for the

was the was Our period for gross XX.X% impacted the partially by higher the higher contribution increased of gross million profit $XX profit revenue third or XX.X% This Rica were changes and Clone. rates between part million U.S. MIA the was offset in dollar third exchange $XX.X by quarter Costs positively of the same costs. for or revenue. quarter from and Costa labor overhead in in in to compared XXXX.Our revenue of

million same Higher in the activities third for in approval a to million, ago loss quarter $X.X an $X.X our period in of the we million in resulted last quarter EMEA loss and increased report to increased in the for million million the approximately prices third in increase a this U.S. operating $XX.X new operations period. revaluation million third personnel net expenses the ago spending The launch the XXXX. As up second our and $XX.X compared in costs the to third of expenses investments expenses the the in our of from of compared $XX.X year increased from Average to resulted third the preparations quarter higher million for approximately in quarter million for U.S. $XX.X was $X.X were quarter of $XX part for the clone XXXX. quarter increase like approximately in in million. the the dollars, over SG&A the initiatives $XX.X quarter from period. SG&A contributed quarter growth quarter in year in processes XXXX the year-over-year. the third to U.S.R&D to year higher the selling from third Total same costs of related and period.Net

as $XX.X position compared XXXX. of to $XX.X million the cash XX September at was of million end Our

tranches of is the debt China Our capital. hand used approximately a to third well the in launches with including sales increase along our on remaining Motiva of which new our regulatory of million of and the now million with in million manufacturing included third $XXX X States.As cash quarter on and facility, These, cash United complete we the inventory quarter, totaled for million in have reminder, CapEx, in the as a in which $XX.X as us the $X.X end provided as become for at which achievement the investments in milestones. access we and prepare available $XX approximately facility,

As from Juan our revenue Jose million. full noted, we year are approximately China The globally, lowering reflects that removed guidance updated $XXX guidance to also demand but forecast. lower

this XXXX. China in in lower we changes gross XXXX expect guidance and but China demand from the basis be contribution margin in quarter, the to revenue in is year, XXX points to late this at are point reduction in in X/X forecasting approximately approval not continue from The expect than any X/X XXXX. timing.We We approximately

includes reductions are personnel control target This and use. reduction global steps in in of levels. management XX% expenses cash and expenses We to taking focused inventory of a costs, operating

expect we result, in in cash meaningfully to third be quarter the the a than As lower quarter. fourth used

to to less we far, fourth based in than thus confident will cash is quarter. objective Our And used $XX this are million we meet reduce we the actions taken target. have upon the

With Labs call These I as We employees. achieve back structure the positive well XXXX be are we very the these Jose. and in in our credit will positive with we cash actions, additional and Juan expect planning have us. important to be flow and on now for compensation Establishment we these objectives our core will in for corporate targets as reflected in turn EBITDA hand available can XXXX. with to believe to cash

Juan Jose Quiros

we and of use Labs of Establishment effect we addressable to poised continue you, scientific will our our and China, new to markets entries the expand and and leading with and our seeing aesthetics this The you so. next Raj. unprecedented global continue taking data With the like expect the competitors. double categories and grow we MIA. transform we into stronger, do Thank market, to our and U.S. many innovations to our products years, reconstruction.For and the share, in become only are company is are few is breast creating supporting clinical by will

about We come. many for expect are very to growth future our and years strong excited

questions. remains turn for the million will corporate suggests now will long-term target objective $XXX a revenue I and Our we XXXX see in your to everything over I be call successful. of the key operator

Operator

to '[Operator instructions]'. yourselves you We follow-up. limit ask that one question one and

comes from of line Your Jefferies. first from Matt question Taylor the

Mike Sarcone

This Mike on Matt. you. Thank for Sarcone is Great.

start, to expect growth I growth could China Just talk your and your U.S.? entering the could resume and you'd comment expectations mentioned there. if you hoping you you about markets be you versus to just newer growth like into, And expecting that you're XXXX. in maybe for on out was visibility for existing the that, parse markets confidence that

Juan Jose Quiros

Yes, of course.

surgery First, I'll and the in tip seeing say often across is and that we of commitment. a slowdown aesthetics many the the markets and procedure are more are more globally, of spear as costly the require

that and transitory grow for the over However, our trends usually tend will are show to procedures time. experience the president these and does demand

a of like and have year.So greenfield the them, the the if terms MIA market And geographies softness, in think for approval truly our and seeing MIA, have this in in United front in new see these the we about then we real, plus. $XXX We we Labs starts doubling of both the Flora can clear growth ahead is to in market think top I technology opportunities States. terms in and unique United this past million in what U.S., Now next between back margin see to a already of accretive, like on softness approval Establishment -- position growth of its received market. in the that a of we more in There think we that, both in continues all expand, are out is ASP and to to will transform in China softness the had addressable we're and States. the of beyond Flora are market. percentage we and of are total time to which about opportunities. XX% many the we see may you thanks be That's there all those and the poised are like growth we of it, traditional of where the approval in But gross of aesthetics, that you of us seen come of old us, the

Mike Sarcone

personnel headcount about U.S. Got costs, it. do That's what look might And talk think mentioned Can China would like to increase you then plan get the that? need reducing to back you the ramp a I XX% you helpful. OpEx. certain when quickly Raj, global And you how reduction and you implement approval in and in again?

Rajbir Denhoy

Sure.

actually of So initiatives weeks. a these undertaken we've couple the already of lot in last

week. did a reduction force we So have in last

happening. So a already of lot is this

I the think we his front in doing as this at Jose noted remarks, objectives growth what prioritizing in point Juan are is us. of

So the MIA, United things China. like States,

So are into making our committing areas for we the those sure best opportunities we which resources are provide growth. that

in you our we have U.S. for instance, mentioned how point, of U.S., we're building so the prepared and at the ahead the business hired we there. teams also out this talked about remarks, And

it still emphasizing in have of areas slower a that we right business and little now as growth where about so really ahead And of sort we are us. lot certain areas of a a think reduction of the

core they which will, these back to we expect continue markets, we As add will markets recover, there. our

just trajectory Juan trying get are where in as to Jose back to period slower. expect, mentioned, be nice these we're We this a in markets, growth judicious on things

Operator

the comes question from from JPMorgan. next Gong Allen Your line of

K. Gong

really about about targets? U.S.? when as for as follow-up, a to being potentially think question challenged the your the kind bit next think the get China just new low nationally I on year. later as softer with a you quick little are guidance targets, and these markets bit those a of well to little then I assuming pipeline a in one What the market And EBITDA but coming Just than expected market right, and U.S. for

Rajbir Denhoy

up mean upon at to take time, I the scenarios of potential for don't period ramping a we preparing online mentioned. Flora a for year, which Juan with time.However, with upon relying spending number the we just we're that remain the already things recover growth of China even even markets now that, a look next and pick X that time. of outcomes like those expect outlook we're will first XXXX, for would based period eventuality markets MIA the I approved, coming improve are where question. new for for know with most growth a for the preparing the we soft initiatives, core budgets our of right, about In we when Jose if period the yes, that So of things don't of

to core where we even market be was positive a which EBITDA second so And remain question, soft think I period in MIA. your time. for a on then of markets And expect these

Juan think â€“ I So Jose

Juan Jose Quiros

Could Yes. question? hard very It's the clarify you second to hear you.

K. Gong

be the just in MIA is well get how Motiva U.S., curious, internationally. think the approval bringing once just question But to doing quickly the you it's as really do MIA you'll well? My great your to you U.S.

Juan Jose Quiros

we implants. approval too supplement that need gain there's and that It's additional you approval is based the because give necessary early first a that procedure, to for the Yes. of for seek tools. on a precision MIA implant the lot And on of to the then Motiva

months. you believe tell a is supplement what result, around a can XX usually I that is supplement, our regulatory this experts to used as that take So

that committed then of international that is implants rest can first available which is very of to the the bring we're we already course, so the one pipeline market. approval, the in Motiva the of of So innovation

Operator

of next comes Your from Group. line Anthony from Petrone question the Mizuho

Anthony Petrone

over and the marketplace it going Sientra comments are similar pinpointed, that in we has weakening Maybe mode like impacted they talked debt the funnel just you some think well, generally, lending tapped kind credit I in numbers the rates of and reports and establishment I'll hit that's here, interest impacted the that's global start underlying And no with there's if U.S. because Care about no too conversely, here be longer demand. today, player demand because the lab see are you when been of comments gotten card and the is or $X from the have on as following in indications trillion? of guess the folks consumers out, in to previously demand demand Credit the high

still So away the while here? couple is prioritization but of follow-ups. issue? of there's spend has demand underlying a demand And funding is procedures, Or I'll for a simply gone the have more there it

Juan Jose Quiros

Yes. the Thank you, our And in developed distributors distributors. you quarter the what tell direct from came that this lower well our half the was Anthony. our I'll that the eventually we received in of as over and orders of orders from XX% is first markets year, reflected demand in around

year.What again. is to So basically of is procedures the patients procedures we not not once normally and tend do recover doctors from we pick that they see this disappears. late of are September, that the did a delaying lack summer, up in happen slowdown Well, hear in then seasonality And in many because interest. we it see

having both I an of macroeconomic geopolitical of lot is in think all aesthetics. and a uncertainty, is there and it impact

periods this whether like market. what the And on in in type that is that makes one for we However, or which current come in many more crisis the of past, the growth, markets don't international case, another, this us in do depend times our for seen back. I we have even think they confident

recently next markets of approval months, see in new the the have few here United States. We've opening market we're United Flora in China the going that, to in that to opening had us. up. the We the And further $XXX after and States with million approval the in approval

of types us. companies growth have all is these that's And makes what that potential So all us because for of milestones them. not confident of ahead

Anthony Petrone

cash clearance. be And a just then thinking on we just preservation FDA scenario we Motiva where and get about follow-up, a a launch under how one should

you to that $XX million limited rate Raj, XQ. in cash, the on be would mentioned first So burn

about Just clarify for limited the be you 'XX? the about get kind that, that half go level Motiva then U.S. that that toward launch want funding clearance a think of is first Is full is to a is would FDA be of to putting more a where should the of next And now unchanged you're going cash we we thinking launch potential million,so burn to or $XX not it market clearance? gradual should where tilt it really here, year? when full

Rajbir Denhoy

opportunities, we've question, in continued $XX as floor Yes, very guiding of we line that million cash again, to growth at be think use level MIA, a move going to our the quarter, we're about that next It's I not lower $XX in we're the seen you've right? million guidance if to Andy, of of growth going United these looking the quarter, that China, forward. into your cash at slow and fourth States, reduction year top level, and some keeping the given,

And getting to we be and end the talk next about have access then the EBITDA ultimately cash we by on so currently year flow to of positive did getting to. cash positive

in And best sort continue more of of provide so I look the growth. of use a us preservation it with ours. to at to it be going areas the as would the is that cash big of focus But

and other to to not front biggest And about find we the of talk so the States. opportunity that of will areas we but the we parts lever United the the that again, capital opportunity, us, in business we'll can underfund look United in and States, to, the devote

Operator

from question TD next line Cowen. from comes of Josh the Your Jennings

Joshua Jennings

is done sounds the has from you driving process that job Any optimistic side the be signals still It's to updates ask it line. just a Or time your by the is matter of year. this just team share to like in just come. end process approval of the that time. You've approval moved on and China that hoping was or China will that optimism? can Pro hand about I regulators your forward? could that's It

Juan Jose Quiros

Yes. Thank Josh. you,

think NMPA. I to front this from that done. going the have get the that And we at signals the think our And before that year, to in that enough going is that the of you on of happen is end final labeling work expectation. is the you're least by usually, us know letter understand to time, I

And XXXX. from recognizing for as are such, to it. we revenue expect now in we However, market begin preparing that

for basis, have everything to a We on team calls if been our early that happen should and according next we preparing year launch weekly on plan. with a goes are there

Joshua Jennings

-- then the XXX(k) to approval. just the the of I question on ask follow-up a wanted Flora And process a about

the a the facilities You independent to in the of PMA prior so review XXX(k) visit by approval. the clear smooth Was XXX(k)-process manufacturing process or X did United the the now States. and have to have that FDA FDA

Juan Jose Quiros

to XXX(k) approval. it Josh, that, a other same leads and is on that a One leads the PMA clearance is process. the is Yes, one that an a to not

implants. of that with is it Motiva the to division looking include approval, And as of at approval people expander, do conversations for is the have the clearance such, same as the tissue to they had both. part However, potential Flora of that the the

as of that manufacturing lot it our not driver same implants. we such, So for no, Motiva are have when of will an safety. which expander. clearance one it the we did of definitely, hurdle tissue of implant, surface And facilities, for having used surface Motiva process approval have Motiva is for important processes we cleared process most important the comes we implants. they equivalent facilities with by that Flora, of manufacture important inspect expect manufacturing a the things an the And But the the to the the the as finish in is confidence biocompatibility.The is Flora

Operator

comes question from B. of line Riley. next Neil Chatterji Your from the

Neil Chatterji

I general as implants? back access, breast guess, you specifically between any Just far faster aesthetic on as for could indications versus that I slowdown, just seeing the come guess the -- demand and new market the I are mean, any augmentation slowdown

Juan Jose Quiros

So more they to they expensive, and more see of usually a because aesthetic first tend procedures like tend it be require to commitment. said, surgical we in you

we're if that's you is for so. an that by not of instance, is So impact, they of seeing But bigger distributors lot that are first to less, will a very I can size they the a direct in seeing it it think management.So get but think are related that very is are cash fact we look XX%, think careful markets, with through they why do that ordering softer their the I seeing distributor more an in impact, markets, market impact we to there. When understand important the in at Europe. that than

sales a distributor majority through revenue is stronger. to until going our are lot So the get of our impact total the in U.S., as we percentage channel. a the go And the to

So first far XX%. markets. saw And you in coming with revenue close now around completely around the from like been this was year, of it's it half, that turn to direct XX% our

the inventories, ordering through resolve we I amplifies are of distributors, get back. come because this think going kind like is of need But the rest to they what to you're the to consume will starts those patterns it year impact. think to they see and with of a I situation as resumption our and going So

Neil Chatterji

gears switching just just MIA. Maybe Great. to

progress study any partners Just updates of on more efforts, DTC generate leads curious clinic the how feasibility is the uptake? X-year results the just initial much helping and and the MIA there for on kind

Juan Jose Quiros

in these because Yes, capsule I onboarding really But when that's as X% terms point is dissipate training is doing a speaking leads second with coming we began our are turning clinics think are women leads the a consumers. with onboarded in begin very appreciated leads.The of is and had now what are we augmentation. the have part leads leading, becoming enough the transferring contracture, care about into can number study, not X% clinics about they traditional procedure and the clinics many difficulty already a things which to we period Actually, concerns. in innovative clinics an X% I has to that about what think they having X-year who MIA, all X of been that rupture, of like tend that something many think campaign clinics. is see these awareness we're good almost well, the think that much that are partner awareness they are clinics fast and that interested is And is what breast that is thought questions these things: seeing increasing. softness these in these so into And I of to people

is to this the softness. going MIA think of I middle shining light be a of in So period

Operator

comes question Citibank. the Your line next Joanne of from Wuensch from

Joanne Wuensch

they take The of do out you it lack process. that can And it? second when in come to of sort question Where better inspect experienced time understand guess and the help are my Anything you the a did Have to us that's for you facility? you of I was with the how with is. give long dig has last where granularly, to FDA that? right word, to term, this better

Juan Jose Quiros

Joanne. you, Thank Yes.

countries recover. like they in Venezuela, and in go see and and it 'XX a ever to deepest situations procedures, markets stopped year through like or you then We lot who in after to recessions where political Asia, least or have the actually, the last of a for Thailand from X pretty Southeast quarters, X tends that 'XX, We've Brazil, U.S., an levels.In we figures within periods bit they certain do I industry at couple the seen recovered Asia, was see a recession tend back tend growth often. to international back that, recession perspective, they were And best think for where which more but then like they Argentina, experience instability Mexico, probably fell have period the years, in market, a similar strongly. to but resume. for

to to gives based PMA. it. Implants, trying us a from for that we comes cannot things past, full prepared we longer, is went approval we confidence the that process for they future, most perhaps know is taking are for come that so back. on are the the to getting are the tell predict to the of necessary to PMA will so we today it that We we convey of it.So when the may we that important And if be are prepared remember, Motiva transitory, modular So one steps also that PMA the this although last you it was

provided us, We questions now for FDA gave to inspection. answers every that module the all awaiting the are the all we for the have and manufacturing

inspection, the the of in breast as do it again, good of well. soon towards a terms Tissue the equivalent was we the as it approval. have receive it are of be I think the clearance Expander important of milestone implant that that many think I a will because to part characteristics So that is quite But as major once Flora

Operator

Your from next Marie question from line comes BTIG. Thibault the of

Sam Eiber

customers the use newer maybe Flora This implant? has that the on Maybe just got Labs, guys guys month. are is you Motiva similar can wondering cell I'm I the like for properties last Motiva that as Sam on introduce it here to essentially to to start approval smooth can considering that technology Marie. surface you regular the if Establishment technology

Juan Jose Quiros

used of heard and the many them had to eyes may that friends it. important with surgery plastic Yes, basically, U.S. basically, was that whatever them in the very Motiva plastic us that's our surgeons have conferences attended think I you told competitors. the interaction have they of for years, if through things that of device think had came few international the because last But about through

most it about to of Labs surface definitely in very to introduce talk what implant. about technology, can things technology talk biocompatibility to we our the is it also it the Establishment RFID important have when is technology.We that So now one which to to and the comes possibility important have about the final we us is our because and available to science equivalent commitment

So all market this breast this give going reconstruction what the us to of which is and is of is many health into company begin introduction U.S. and about, opportunities this concept to women's aesthetics talking about for eventually. the

Sam Eiber

them for to, Very forward appropriate rate on top assuming that use I maybe But how implied be. the long to an this now can going QX open follow-up the the core be in some layering that And would markets of guys guess, then you XXXX up? and markets guidance, for run million, as of here new I out right environment transitory could it's good. use Okay. I my know $XX.X difficult Raj. figure

Rajbir Denhoy

a distributor I noted, much bigger we've our bad a seen mean point. I we've not slowdown in seen It's direct markets starting our than in as markets. one as

MIA, should not Flora then that, like expect we're don't top on United time. approval to continue But to the that's the we mentioned, in layer start going States.As so period contribute things a of Chinese it, But base as with close Juan bad. you a And to that start year. of from, to very conservative next that that's

the of the these a on terms the for have And we fourth that. quarter lot we top be in should expect see that demand low things we really products. do good of So that build watermark of

Operator

next of George comes Your from question the Sellers from Stephens. line

George Sellers

Flora should apologize XXXX? start in about including if And also, maybe to of you that Expander look guidance Motiva like, approval in I just take with I'm the might think in use U.S? market and typically on the physicians curious anticipating look Tissue that -- that like the the going really your commercialization have fourth I'm need is then to they're how in quarter for and to Flora, does what we to curious Or off U.S. see that I to in Maybe same you're this, cadence what what Do missed the but the market that implant the use?

Juan Jose Quiros

Yes, of course.

It on XXXX. unique is opens in the no these with have, magnets, many we centers things ways. Flora approximately now oncology. for reminder, And tissue it million, the for for in the them MRIs, that first radiation prices up world. science, of can expanders from we has the which all, because So opportunities market average really the do U.S. start can a the amount revenue U.S. the different they based and new as potentially generating highest will just the technology changes they technology in with in reduce $XXX selling in of

for it in change United So States. is centers these an the important

you tissue So very that it nice as from with recovering if look interaction is breast cancer. what does forward, do, a we about Flora like creates think inside this patient

for who for you a United see So benefit a as that it Flora approved there's capsule would the our that this Tissue Motiva for already capsule to that capsule an can understand be have. surgeons not created manner the the But is initial implants. eventually such healthy tissue host the implant believe States that our of in And type Expander. reason breast but is no is that reconstruction to define thereafter, in that going or

George Sellers

really the then That's And on Okay. process. Motiva maybe helpful. FDA

on touched the inspection. manufacturing You

manufacturing line been after given left are steps time or what you seen that curious should inspection? on when Just And expect any that? have you

Juan Jose Quiros

No.

But but line week I every time is terms to single all Like FDA. which scheduled answered. questions that coming Module is answers one questions in of we any we given because it we our with before, of not question-and-answer yet provided the make have have process process in the have to said And now. week to not progress the tells hands. been continue well. have that that of you their inspection, along quite They that have manufacturing not is X, We

expect sooner we to later. happen than hopefully that So

Operator

time for the Chacon is call today. we back remarks. That all Juan questions the over to I Jose have will for now Quiros turn closing

Juan Jose Quiros

Thank on joining today's us you call. for

Healthcare We the to London will everyone be health. we update and our next good year, Jefferies attending week. forward Conference Stephens wish continued Conference providing quarterly in the We and the Annual new look Nashville next

Operator

for Thank your now and conference today's concludes you call. participation, you This disconnect. may

Establishment Labs (ESTA) 7 Nov 232023 Q3 Earnings call transcript