Revance Therapeutics (RVNC) 24 Feb 202019 Q4 Earnings call transcript

Company Profile

Participants

Jeanie Herbert	Senior Director of Investor Relations and Corporate Communications
Mark Foley	President, Chief Executive Officer
Dustin Sjuts	Chief Commercial Officer of Aesthetics & Therapeutics
Toby Schilke	Chief Financial Officer
Abhay Joshi	Chief Operating Officer, President of R&D and Product Operations
Annabel Samimy	Stifel
Ken Cacciatore	Cowen and Company
Holly Barra	Goldman Sachs
David Amsellem	Piper Sandler
Balaji Prasad	Barclays
Tim Lugo	William Blair
Seamus Fernandez	Guggenheim
Dan Clarke	Mizuho Securities
Serge Belanger	Needham & Company

Call transcript

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Operator

Welcome to the Revance Therapeutics fourth quarter and full year 2019 financial results and corporate update conference call. At this time, all participants are in a listen-only mode.

Following managements' prepared remarks, we will hold a Q&A session. [Operator Instructions].

As a reminder, this call is being recorded today, February 24, 2020.

to Director conference Corporate of Revance. like Jeanie over Communications now Senior Herbert, Investor would turn call the to for I Relations and go Please ahead.

Jeanie Herbert

Thank Jewel. you

and today Joining Officer, the Schilke, Aesthetics Chief Sjuts. Product Chief President Dustin Chief from Operations, Chief and Toby Executive Officer and R&D Revance Financial us Therapeutics, Officer, Officer, call Commercial is of on Operating Dr. Foley, Mark Joshi, President and Abhay

ended December today, quarter year Earlier released and for financial XXXX. fourth the XX, Revance results full

If to list release go be future you found section this would or be www.revance.com. news please can Relations at have not the received of like to which Revance's to releases, to added the Investor distribution website, company's receive

statements, respect potential based financial technologies. TEOXANE risks financial our operations, Revance's the including statements distribution During conference and business plans, to this and related the results development of uncertainties. company's guidance. forward-looking and XXXX on the product forward-looking clinical candidates, precommercial and estimates planned These inherently current strategy expectations call, management agreement involve launch anticipated and and make and to significant with statements candidates product will are

obligation forward-looking a and new undertakes future cautions changes on statements Factors and titled on in statements undue factors of uncertainties. not duty events section differ any events the of expectations. of timing from on or those include to the reliance its could report cause SEC a the February XX, materially that Factors current company our X-K, you in Risk different anticipated results those these result these be to actual XXXX. such statements Our Revance as from as in Form the information, statements with and any describes filed forward-looking forward-looking or as could update no result place in risks to results

now Mark? Foley. will call over that, With turn I the to Mark

Mark Foley

full and fourth U.S. of important a call. Drug XXXX, you Administration for several and and or in DaxibotulinumtoxinA our year Revance for clinical injection In joining neuromodulator, progress also Jeanie. the short for made enrollment quarter you thank while Good to afternoon and has everyone to significant Food submitting of XXXX application for glabellar leader trials Thank DAXI our a conference for for will initiation transformative us for lines. license in biologics up therapeutics. events treatment and the that characterized innovation generate both This execution. year Revance XX progress position XXXX less transformational no by set we an our XXXX, contains a clinical, significant excitement be company be believe aesthetics than value and and regulatory could commercial which and the

moderate-to-severe of and fillers of approved the RHA FDA facial of We the generation correction dermal signing highly dermal portfolio of address out only TEOXANE's agreement physicians approved a create patients needs the wrinkles look dynamic for resilient and acid folds. DAXI, Together and as complementary an for facial neuromodulator, year kickstarted we TEOXANE's modern the build range these quality fillers, U.S. distribution alike. are with first synergistic to the hyaluronic of our next aesthetics exclusive fillers products range high franchise. of with to or our

opportunity assuming U.S. annually, the $X.X we to the agreement, the filler DAXI the injectables facial a RHA which distribution year. this to growing field is to aesthetics billion force, our launch, category in TEOXANE's the market of U.S. access with buildout injectables a perhaps market, this that With get shape will provide forward later importantly, help premium most and XX% optimize Revance of pull new approval ability facial the whole portfolio fillers

on perioral space. already are rhytids, This to which the we X, further X fine innovations and have rights also estimate three launch the fillers months approved, filler to timing investments approval in around by for internal and the XXXX. XXXX. of the our X dermal XX anticipated DAXI, mouth, of to RHA expected that are and projections for payback launch launch the XX Based filler dermal breakeven Beyond FDA after includes lines X, RHA early distribution filler receive in we FDA agreement within

successful that Following TEOXANE correspondence, heels and the lines no of remain our hold our a the potential our team. target review committee an currently the our that in DAXI date stated the submission The meeting. accepted on review of FDA XX, also there advisory for BLA to PDUFA focused was In for confidence filing We notified issues process were and no experience have identified FDA set plans deal, November review XXXX. FDA on its for ensuring the were we by that action glabellar and quality are FDA. of the of

These clinical forehead From label a out fasciitis perspective, our our X DAXI continue December in facial include clinical plantar aesthetics readouts X in a Phase have made with to readout ASPEN-X X cervical Phase and crow's development trial bear pivotal a dystonia. new read in investments facial trial we from XXXX. readouts Phase feet clinical most trial perhaps lines, planned in for we open lines, for upper initiated will trial and the in in three fruit notably the five for in pipeline

Sjuts Chief fourth President Executive and terms executive promoted and quarter, Commercial during Chief stepped of Dustin I we the Officer. in to In as Officer management,

position Technical to to and President and R&D We also Nejad Operations promoted Abhay Azita and President, of of Vice Product Joshi Operating Senior Operations. Chief Officer the

and to our President, at Ultragenyx, company's joined Counsel, us operations, team appointed general Prior in global where Dwight regulatory matters. from he was & extensive Ultragenyx, Counsel To positions GlaxoSmithKline. recently leaders Secretary. as overseeing served Corporate commercial General to litigation, we Vice the Deputy of legal continue President, Moxie and research, General build and counsel Vice he commercialization with experience, Senior development Allergan Dwight

member to will executive of to a and Dwight as thrilled team. me welcome senior are the and serve Revance Dwight the to We family report will

and launch, Dustin? I filler Therapeutics, dermal the in the you will an Now call to and our hand Officer, Commercial Chief to give our update RHA on over Dustin progress aesthetics Aesthetics Sjuts.

Dustin Sjuts

Thanks Mark.

the are completing RHA commercialization our launch planned line we the for activities our you can second in of busy imagine, dermal filler As quarter. U.S.

As to on Master discussions facial fillers. the X TEOXANE level line RHA line. at properties Science our innovative the recent registration And our on on on two differentiated annual posters. of focused part two, RHA in and the and launch One Paris, of TEOXANE in showcase physical Congress injectables. comparative results of Aging the progress U.S. trial International IMCAS for study from or to a Revance portfolio presented World of the Course were multiple plans, Xsecond demonstrations and dermal perioral high allowing us figures both

their a from the along dermal dermal portfolio. program also symposium U.S. educational resumes, ran room results presents generated the Overall, X application range compelling physicians clinical opportunity the TEOXANE unique standing aesthetics and we in DAXI. distribution RHA the than received Phase TEOXANE attended over science this on further fillers Since XXX to conference X,XXX the of the with growing announced, Revance demonstrating filler only SAKURA the and have introduced on agreement more were of marketplace.

turn a completed our sales which selected our and second quarter. thorough and nearly will Once have place for we will positions onboard, leaders. our We executive aesthetic selection launch in be account for attention process to the in vetting

better experience. the who value opportunity an serve a and to consumer physician see We

will key strategy be these marketing focused Our areas. in

value a that products quality deliver providing First, compelling proposition.

select outcome professionals a consumers. of Second, discerning improved the with aligning a delivering network And the consumer differentiated aesthetic and healthcare finally, and for physician.

Turning side. to our operational

two, to customer technology best. service end-to-end high built do what touch the our and teams two with they infrastructure customers projects. key in nearing on function to technology completion of right a the One, are the We processes. sales people, experience mix mind And customer of focus and with enable infrastructure

for of offices a neuromodulator the allow aesthetics. The our help approved, This as compelling fillers injectables create new to first significant powerful RHA the the physician with the DAXI. launch relationships, facial across market next-generation strategic facial of put is concept Revance product, RHA the category and share Revance road dermal us to time, potential The combining put in facial and of launch the building ahead give well TEOXANE's constituencies. will aesthetics approval portfolio and will in a injectables. all once filler logic of us representatives along premium DAXI, in TEOXANE dermal DAXI premium optimize introducing will on us

our enthusiastic is for exceptional into booming about the excited facial injectable plans and team Revance's Our entry marketplace.

With Mark. that, I to call back will the hand

Mark Foley

supporting Dustin. Thanks PDUFA is November our process. our approval date announced DAXI XX, With the our BLA of XXXX, on focused acceptance organization and

clinical team Phase will X completed. that become amount up X is Phase once in Our for of substantial follow-ups and been clinical the our available data the have also trials gearing

DAXI compile year label These will studies all practitioners completed before at medical generating are X will aesthetics, conferences. and information facial In Phase data expected package be launch. potential enable a shared upper to comprehensive the of end key be for three DAXI's open us to face available results we with

As cervical indications, our expect and XXXX. report to topline complete second X data ASPEN-X half to in in for enrollment results we dystonia therapeutic of is clinical pivotal trial Phase the

Phase of fully enrolled fasciitis announce trial we plantar XXXX. and these X Our is second expect likewise in half results topline to also

spasticity both another of that Phase X end and X major Finally, which enrollment that could materially the continues the of have disorders complete mid-XXXX. inform for one disorder, year program in Phase means, we patients. in of for in therapeutics. program to upper X positive DAXI We could pain be Phase on opportunities limb the muscle exist to the a in JUNIPER enroll by movement anticipate data This a

our to asset. biosimilar Turning

forward whether for until Mylan XXXX development waiting to opt-in. Mylan We XX, the not plan with they or has biosimilar are decide on whether Botox move indicate plan they to April us to to to up program.

our corporate of bulk recent the covers highlights. That

over comments summarize Q&A Afterwards, will session. call we the Toby few have to before financial turn results. I Toby? a closing me let Now begin to our today's

Toby Schilke

Thank you Mark.

$XXX XXXX million operating biosimilar and million fourth expenses. the a under expenses controlled below and year, program. full the full Revenue the for results. GAAP guidance million earnings company range tightly expenses see full financial guidance $XXX recognized and $XXX OpEx upfront result, the million. the $XXX year payments quarter the the to $XXX,XXX release year-end of of of our the incremental Mylan to compared Please million as spent of from GAAP $XXX operating For Botox consisted we from for to of XXXX as non-GAAP to million $XXX with And the

the had enough $XXX.X we With Today, XXXX. XXXX. to February company short-term investments on issuing the are cash, into just for financing we fund we and cash guidance XX, equivalents of our million, concluded

research in million We $XXX expense, and expect to stock-based of depreciation which $XXX $XXX and to non-GAAP to driven XXXX a over development excludes $XXX range be launch expense the Revance XXXX in compensation, million. activities, to million the XXXX by of including expense range force quarter. to increase in primarily million $XXX be GAAP of second field million. the non-GAAP is and operating $XX The the operating expects million hiring

will until of our not line. of guidance the terms determine we trajectory we can launch In sales revenue, RHA provide filler

We XX.X XX.X million outstanding approximately approach February shares. will however progress the as on we updates provide fully XX, as market. of Revance's were shares XXXX, our with million diluted

And back Mark. with will turn that, call to the I

Mark Foley

Thank potential Revance of number you events am and year Toby. us. significant of I for pivotal pleased XXXX truly ahead is value a creating with the

important With the positioned well launches our injectables DAXI, as innovation deal two capital Also, funded facial are we data well await neuromodulators. an approval to we product we and the prepare filler significant TEOXANE with of and and for very leader readouts. dermal therapeutic raises, are recent clinical in anticipated become

a billion of and be With $X.X more to launch with on ability and execution. from investments, position than cash we will an strength in laser-focused

the keeping BLA catalysts to achieved We have year. the agreement the With two our TEOXANE XXXX. in look you first we XX launch XX and remaining for activities forward catalysts updated of the on throughout acceptance,

I that, open call will Operator? the for now questions. With up

Operator

Instructions]. [Operator

Samimy first Our with comes Annabel from question Stifel.

open. is Your now line

Annabel Samimy

guys. for my taking questions. Thanks Hi

to you a coming So you wanted launch of possible category. the none guess talking there of us since do I the ask price and need am marketing I DTC? TEOXANE? can you up frame than the the guide question, potentially question necessarily the maybe coming me around about cash And the therapeutic and if Juvederm leverage so But of is, Thanks. that cash you same any guidance XXXX, increasing on to is other there given the given as sales The on to spend you What then second XXXX some essentially of expenses? for XXXX us, you burn revenue but have increasing one the think in much continued guidance I implicit premium just a that more how on the And could don't surprised yourself finally creating pricing be development. the year up premium on establish to assumption again revenues thoughts didn't from next is noise some are in in wondering of bringing cash? launch you by shortly, should of any launch you give these is repeat into TEOXANE you

Mark Foley

thanks will This I Annabel. first one. So is take Mark. the

the hold pricing going we a until to think of pricing filler But giving reasons too. line, are terms of do In for specific TEOXANE the launch, it's on probably competitive we premium product. RHA

has product. in themselves of markets at it's market. label and to job a nice if wrinkles think look dynamic folds, Europe, product way top differentiated performed the the And great a they around how in If have a five claim you look the position you I that done at in unique

believe stack DAXI And the will product. so around pricing very hold And that market. we other fit it it fillers. premium very until into are sort nature of the we that get of with consistently the the up specifics think we going against will we on to But the favorably and

the I of we buckets XXXX. sort spend sort little given a we Toby guidance and can he that makeup over have at turn to on look that key comment that the on the Regarding as of bit one, for where of the

Toby Schilke

Thanks Great Annabel. questions.

associated the you You year-on-year, launching drivers the in bring the both then terms in XXXX. seeing of the and field acceleration know, our variable our DAXI force marketing because increase with filler plan an to and of in of obviously are

as making XXXX? of, You expenses that are have additional the is answer sort going of into know, investments the But will sort about And from numbers, from and question one-time we on XXXX They systems. year-to-year your some were information sort year XXXX, shifted of are was to sounded roll-on full year field the we mainly infrastructure of to context, yes. field overall force. on that we year it technology are full based the sort hard the the especially of discern and like in they be for have ERP of sort effect

Mark Foley

to I two and a mean that forces sales outline know these answer more. of and thing an little that just the great that of is synergy overlap little the both. there a products you sort Maybe is about between

year. the obviously into support DAXI marketing not need additional we that. a to that add costs sales filler and this of is be will It's that. what more the going a while to gets add investment the forward approved, marketing to so, sales forward sort pulling And are We there be going lot and might supporting the infrastructure of a expenses whole later. sort to reflecting. force of big by dedicated that's some be to launch, is pull that's isn't duplicated of time this And reps some number but of incremental lot that go There

Toby Schilke

had baked you the revenue think And is there and are lower there. last launching in there. revenue, products With we of a about you cash But you guidance because decisions XXXX have I two pretty and take one we have With on confident we then sort higher on And XXXX Great. feel different obviously there that forecast question, revenue, number. Annabel, balance that. investment.

Annabel Samimy

Thank Okay. you.

Operator

you. Thank

Cacciatore Our with Company. next and Ken question from Cowen comes

is line open. now Your

Ken Cacciatore

guys. Hi

or thinking of any want be launch? don't for you you revenue. about we I should looking should the specific know talk that measuring you a to you I And we want we seems there be the metrics any how on more of give are things can question a Just obviously the sense, about give revenues any DAXI don't force But pacing out for expect then XXXX. XXXX TEOXANE? should we if out sales event. when to in be to know us on going DAXI get they And

So then and to is in monitoring? attention yourself that holding accountable to that you. we to the And on are just Thank force for Or of tight to competitive that are that team things paying sales you hold purposes? terms thoughts you size? and be can going any metrics

Mark Foley

Yes. Ken, questions. great

one latter the try first. will I So

XXX that we have that we we might DAXI to up been start pretty consistent launch, what talked to how have about to of And to into wait grow sort XXX. think plan of are will XXX reps with. the know, we start kind out this. with see we we plan gate is phasing But to do I we But of reps. saying XXX roughly you roughly

that new whole the to metrics sampling those getting of I expect cadence be hat launch bringing and there, right be terms will and targeting sort think I physicians. and a on to we expect launching we phase would sales In QX of what in first and force, since heavy are and

revenue So start of the line year that I are think this. way on more latter is to the any because the going kind of to the filler towards part of we to be phase going

same finally that it's the think optimizing clinical are well. important outside think of When launch. we I a will time trials. it's make partnered And commercially first with going select get DAXI, And for really the that used the DAXI this be of approval we sure with be group we as that are to physicians to I

meaningful contribution And until so next we DAXI don't year. on expect portfolio the really any

some And part towards brand coming things about weighted make year. of QX we expect this sampling on filler that we back with, we again, premium that And in more the are we online be are to partnering physicians want are side about. it, just talking the really are sure then just again we that establishing the since thoughtful being will and the of

Operator

you. Thank

Our Sachs. Flynn comes Terence from question Goldman next with

now Your open. line is

Holly Barra

question. Terence. taking for on Thanks Barra, the much Hi. so This is Holly for

Mark Foley

Sure.

Holly Barra

assuming target are planning this a on that in is filler updated physicians, initially of you the is DAXI now for you with year? Thank One, broader can you approved Two potential were than to DAXI? just thoughts base later strategies, planning us. portfolio bundling provide you. your And

Mark Foley

Yes.

great So questions.

the strategy, themselves. we having in bundling them, Clearly, that the consumers marketplace. to the actually sort the the specific fillers both to until we the tactics us of give again, think in will market. in meet until pricing hold the on by us are opportunity into flexibility an on it think I does the hold are specifics on to sort it and them. So needs and toxins But offer we of of incentives both having any injectors greater bag, of by utilize both get of to we the that again, both of practices of we are going And give

And again, terms base, us whether sort it. or of of get target are then the allow I going will to execution in not fillers side that think broader of a to into the

right we to be the are going are value think think of a think are ideal we job of both go if the right after whoever good is whether able proposition for should creating educating customer we we it's that and making neurotoxin, be to for we the We a products. targeting sure that that training to us. But and that or going our physicians we mindful a fit filler of do be

So I of and that strategy. go-to-market way about this the changes products don't these think ultimately market think either out we

Operator

you. Thank

from Piper next David Amsellem Our comes Sandler. question with

open. now is line Your

David Amsellem

Thanks.

a just So couple.

experienced gears patient idea premium wanted experience the be? as Is this think And do initial who patients in two, we about for and to are it a how Mark, therapeutic asked of of And or the you but idea indications? So to context dystonia to? that your commercial the get premium of product able building therapeutics then are cervical partners filler going last I XX ask all you referenced couple the infrastructure to how had speaking to are to about other who in general? fillers And that say, over initially? Do switching you years, experience? pool different in patients thoughts experience? to one. will will in I out question just be have different potential just premium number probably TEOXANE indications is, for think who the are looking again. be in, therapeutic ways number this that something disorders at is that of you it And Or new you or or get Thanks. wedded That's fillers. in think broadly a And vein, these some of a should or looking will on movement you the I

Mark Foley

great a question. It's

think I I are a of low about market heard industry. to be first who have fillers, launch and one, kind double other think So with the your growing that we underpenetrated you the this continues the is it's significantly from of players And question in targeting XX%. consumers? This digits, which

into think awareness to something new. I is the new that that So people it does what's drive comes market, increased consumers there like any and seek time among out

those that will think that as get the new filler the patients do in that's already about from haven't channel fillers hear channel traction that in we outside our an sort use either opportunity. but the had of some are are So next the we new market and or of that

experience will likes we looking that then conversely of in the come different we a some might properties or think fillers some And to for getting appealing think get that be new that going for I that that performance be are physician too, the the alternative are channel consumers really a of I in. already and are So consumers filler. definitely the

TEOXANE's compete top Europe, strong which I been five mentioned fillers able benefit market, as in have without of is the European really a a very and highly before, neurotoxin. successfully in they has to the markets competitive And been

been have product. they solely of the so performance the And competing on

we will some new going well. So ones into be with We And think and drive we coming we market, injectors. patients will some resonate to to think capture resonate existing through it's some it's it's We think the we to going consumers. as going think with competitive. some

both Obviously, about real your of We our always in therapeutic aesthetics our as sort be question America distribution would would would you outside that that would the and find of products dystonia. no cervical there. in be talk North terms different it. and neurologists of sales In strategy, continue said, in rep, it's U.S., our XX pretty currently so effort the a in if the of build those indications. own sales about force, change to it's to a controlling referenced, and need targeted of commercialize we be look XX these to therapeutics partners looking sell ourselves is could These neurotoxin to administering kind We for force it this partners assets in to to we which could sense, we directly North think and makes strategy for that that America of we look outside that. that continue

we evaluate Having look that continue you that's going are XXXX-ish. are time is furthest in second our an approval some and said at if that, in But to advanced X talking reading to most is opportunities. Phase of program half where this the CD year, about along. data you out and

with there our time it. for clinical value up better circle the back right for will that unlock that and no could still strategy think have we some is in we we additional But ways reevaluate, and change approach now, are data, is this there So to certainly or real other market.

David Amsellem

Okay. Great. you. Thank

Mark Foley

Thanks.

Operator

Thank you.

comes Our with Balaji question next Barclays. Prasad from

Your line now is open.

Balaji Prasad

DAXI. questions Good progress on and Thanks for taking the Hi. afternoon. congratulations on the

give market? that Firstly, there of globally? fillers any on U.S. that this of it your does pushbacks can on ramp TEOXANE trying to team? dynamics? to learnings this you us kind any Can KOLs. minimum have to consider? what asked something for there And understand I period your on the and the Were you I fillers, so expectations Thanks. we need dominance introduced Were understand you said the Secondly, help that landscape am competitive last the around month. development recently it's

Mark Foley

Sure.

with always and over. can I sure your we not question, one understood first exactly am but I will So pivot the second then start I

response, terms leaders here the and with sites to of on physician in lot so involved to trials, clinical work go in been trials. clinical So these industry North with in what's a companies America were these were trial thought trial that there the like of

injectors And products so with shared great with had the they our these that information colleagues. TEOXANE and experience

a very it. that come so had U.S. with group into favorable KOLs market of with the experience And we

Secondly, meetings share international there attend of a is a of these where lot they number and KOLs information.

meetings. of of some it. U.S. lot the some that their the seen colleagues TEOXANE are United get they States of products the to on at fillers outside injecting to data their these the and the anxious been a have So talk physicians They hands have on

the is the how performance of it very to that easy but the softer is it. sort side it terms on of what's product the of it, patient think I massage, to how inject, it easy is feelings in how performs, also good of

sensed lot so meeting And IMCAS it recent were because partnership, the and attention about, paid of the at that to physicians more announced we talked there U.S. that we a of this certainly and excitement our with with filler on get have line. neuromodulator with to of new been are already excited we engaged the number experience the that they physicians program, certainly

the going in good to we performance the that going And drive product of number of also large is and product. we think so interested very physicians trialing experience and we product have going to are are be we that customer to think the as come into on the a the U.S., the usage

Balaji Prasad

Thanks Mark.

Mark Foley

around We an a that fillers other claim position us dynamic marketing gives opportunity us way standpoint folds in to unique also a wrinkles labeling ability their certainly get a think and can't. that to from that

And feel so we about good that.

maybe And for you there? were could your then again, for I because clarify what you me second sure wasn't again question looking

Balaji Prasad

Sure, Mark. Thanks.

on the all I landscape could am period being TEOXANE trying future? at And have what this up said, of the they lifecycle that was, understand was of TEOXANE market? to in can And and end threats is to on competitive development what So kind be? the what minimum material understand I to could dominance fillers asking competitive

Mark Foley

a It's question. Great.

there way it's obviously, into see through fillers U.S. a in come hyaluronic do market. the U.S. to two so are markets and are their expect sort probably of other to that approval focus system fillers But the so three FDA next on acid So some years, to agreement, will years. the some we I other the working closer three

have market. feel like into we several years we to the So get certainly

neuromodulator a this obviously because by do we and really partnering with injector patient. the we then, filler needs order is the to did And the meet deal distribution believe, important in of the

more coming of But And filler the so ones products in well. share there be the this technology and higher number are are TEOXANE the bar. latest so, a five going They are of with market has and we all where going think you in top already of most to of create is competition, sort to which the much EU if new competition. only sort and holder really is these performed at Europe approved four the all markets is look

this which a is we partnered several to filler new continue to neuromodulator competition. that perform does be going think won't really is next even any help that we years think well the fact up, and the it's product there several to with the then And have the us line is So position. competition really our years when good a for going of show away, and quality that's

Balaji Prasad

Thank you.

Operator

you. Thank

Blair. Our next question with William comes Tim from Lugo

now line open. Your is

Tim Lugo

you on QX. done all as the as for in Thank question the and well congratulations you QX through have

is in we Specifically, of without can think which expect Europe cited for penetration that paired the neurotoxin a X% floor I appreciating? a with fillers Is that unique penetration that about not number for am should been the we Europe, U.S.? Or sort there has something how in TEOXANE them?

Mark Foley

around of founder to to but the was terms us being and manufacturing TEOXANE to we came the how days think hard to at forecast fillers not means. we into And the of largely the involved of easy quality work the down then bodes Taupin, it's process attributed well the which and art else product. how making the look there, for We and comes and creating Valerie Obviously, what I into science look market, to that usage it and in everything learned a if sort translates easy at you the it fillers Juvederm in of is of it that lot HA how it is the early just with use. think

of the So think it it. we to speaks quality

Obviously, at we it it's a point a that and don't of got that to right to it. indicator pair it's X% really for that we a U.S. established certain prepared And that I think and means. are when here. of the sort we then we that think translates you market. say percentage optimistic. where we give hard I the just have level can as move know we But also that there are need us into on with properly time neurotoxin relationships what to we get for into are sure good DAXI. market make guidance We the a

Tim Lugo

Mylan a program? Understood. remind something decision there with partner Or the them is would dynamics a changed bit a continue Mylan bit? made have pursuing that preferred your to again, And the changed if maybe to are market has or partner? up, repartner decides program, looking a where with you look you coming that unique the Or me not even to biosimilar biosimilar now

Mark Foley

great It's a question.

before. about talked have this We

into were entering agreement we other Mylan, the at Before there to with parties were that talking that time.

was is lot to felt like the XXX(k) obviously pathway. that there, When minutes there it of have working available or the agreement, interest was And was did a the XXX(k) So partner was not and got meeting been in into based two looming pathway that were we we agency best pathway available, risks experience One We meeting were great a a the They space. there from do that doesn't is not with us. for them. large. have notes there on others. unknowns entered say with there was that but Mylan that whether our us their feel it's

needed that characterization work second made side. done. more And like progress And the the characterization be on thing good have we was feel there to pretty we was, was

reason, for asset if at is, on now? like Mylan that do We okay, point, made where some same go decides decision like progress back would feel opt be fronts. feel of to we we in, been the the has based those which we not that's derisked So whatever been on

we think so not choose take a sort opt step will reevaluate and they And go pause to we where and do from I back if in, here. of

Tim Lugo

question. Thanks right. for the All

Mark Foley

you. Thank

Operator

you. Thank

from with Seamus Guggenheim. comes question Fernandez next Our

line open. now is Your

Seamus Fernandez

Great. for Thanks question. the

So quick just a of couple ones.

in of second talked as guys then launch we hear in the wouldn't U.S. are things. TEOXANE update And fillers? physicians what nodules. supply sort service opportunity can we with the hearing sort just that the And some about on for you hearing you And you includes prepared thing from also there are to then complains the with the is fillers, are mind, to which you is, If two kind starting physicians, us we with formation to margins. fact, are market separately, Juvederm of of TEOXANE that is one problems of the just on the about

to there? from trial learnings confidence X? your approach what how thinking since Phase you forward gives And should you about us update like to Just the your on give of unique fasciitis sense seems Just thoughts that move the as question, opportunity general those on a then plantar they us a can opportunity? the that data we the be love just last were hear into clinical

Mark Foley

great questions. Great. Thanks. Well,

first supply it. So off, of on side the

worked amount color forecast given on or we and sure does and needs haven't forecast. sort adequate launch sort to the make guidance or sales minimums have product that agreement We closely the our around our of of that. contain have any of they to those support with TEOXANE

So we enter market position that the about good feel the will very with. we

terms looking and Dustin market? the going on nodules I of that on at hit you question, what's the In here. want am to in of second sort

Dustin Sjuts

Yes.

relates are the you think was that little in about introduced hearing bit I as Vycross it technology a XXXX. to

to was to market introduced didn't I U.S. worldwide, the TEOXANE Valerie understand in it's but RHA Vycross and of has more come XXXX think the while it changed. important recently, the until XXXX. filler introduced dynamics

into understanding product an RHA really technology. how was They engineered how that took drive it created when they characteristics. account of had the that different they made, So to was

that hearing are well. we as So

profile the information to filler I than has worldwide. don't specific XX known. think safety we have is Vycross, of sold the well TEOXANE RHA million the but more itself directly

it's think I as this So data important safety. probably, to set to standpoint understand and have very from both its efficacy an something that we large that is a

information published there data will where IMCAS was that at as to around products. bear of definitely safety of conversations characteristics happened well we those publications some So different bring on different of types

in understand And there things, think XX,XXX then that aesthetics. now of that there it's side out account important I on service XX,XXX there really data and is the to

companies to of sales sizes with forces. those so call out trying And there different of all are most out

experience, are which a within marketplace us from the strategic side a of We allowing allow making with company will this partner that create level very of both going to service certain accounts on to which higher new to us. are premium and a type have the decision product is a much

great So a as opportunity we that's do think well.

Mark Foley

over question, the answer to to turn fasciitis I plantar don't Abhay why for And that. it Great.

Abhay Joshi

lot so first a think plantar changes instead Seamus, side, made here we of dose. a what are Notably, design did was, that on of study. Great. trial I the we described doses have to have we learned we number our from because plantar the two earlier one

we have a high and a dose. low So dose

our on talks rating numeric analog have scale Secondly, we compared a to less distinction between you scale changed a a of experience. the primary about which pain endpoint visual based is where

entering one a one. included analyzed period. is just how to and ten trial also what We is like an pain first feels particular the psyche that around patient. the patient that overall for a feeling is idea day us how That run-in ten behind day means And than gives on for that the into the patient rather we days

trial versus duration an made surface at what have we scale, months that for calf. the had location evaluating that is numeric last to changed versus one of with we we not and of the We to are over our plantar where gives not the plantar week to five but study. and injection we the you change very only a six at least, regards also three And changed days first XX because rating day eight. number opposed average as significant And months pain

opportunity, based there to all learnings, changes significant believe our we and that with forward these we as you data. said is look on our So

Seamus Fernandez

you Thank guys.

Mark Foley

Seamus. Thanks

Operator

Thank you.

question with comes Securities. Mizuho Yang next Our from Difei

Your line open. now is

Dan Clarke

Hi. Clarke, two, for is Yang. you have if Thanks our taking This on for Dan I don't Difei questions. mind.

now approval First, that follow-up, the RHA portfolio? of how for your potential an much line? changing market have the then And for as X the of benefit are in share a DAXI, would filler you assumptions Thanks. incremental given TEOXANE you be

Mark Foley

Great question.

really haven't assumptions no, of allow the penetration we like there. assumptions, in penetration two competitive together, So sort we will any obviously more we in accounts feel that the targeting. of are put to be But terms out it us having

us So need what that's compete flexibility do. the cases more in calling bundled and because overall, to if again it's the same to same But give we certainly reps many efficiency on consumers. an treating in it it's the nature, probably play injectors same a will

And the question? then was RHA, on that what

Jeanie Herbert

RHA.

Mark Foley

Yes.

most X, the of today. side, So RHA X the and on X meet feel needs the X, RHA we

mouth. X lines fine is RHA filler the So the for perioral around being designed

is product of we actually this be a unique bit going when So think the it to that comes more a into marketplace.

XXXX. in approval expecting are We

it's lines, we superficial get excited of excited product again, are in more to finer So that are the much in. to one really get market. that But sort and we

to that, want you Dustin? to add Anything

Dustin Sjuts

No.

it. I think you covered

Mark Foley

for questions. Great. Thanks your Okay.

Dan Clarke

Thank you.

Operator

you. Thank

Our Serge & Needham with from comes Company. next question Belanger

Your line open. is now

Serge Belanger

Good questions. Hi. Thanks taking for afternoon. my

back talk were maybe maybe go assumption the Mark, I investment on by within XXXX? The have wanted expecting positive of and behind remarks TEOXANE I you launch prepared to correctly? dermal you months the you that? that mentioned that to can ROI of one, a And that some first that some breakeven in your comments XX of your Do on

Toby Schilke

will Thanks. Serge, This one. I take is this Toby.

XX we said So in our to we prepared breakeven after on launch, months agreement. XX filler would distribution remarks, the

the line we be XX then the payback over to the that we and And what selling have made when that by to XX you also So in XXXX. is, that by we at that's of there. months look the as breakeven would mean filler DAXI while investments what of obviously, we first U.S., that meant then economics so

Serge Belanger

these facial for question I out My areas. the weaning this wanted trials on X Got various think to I label open two know clarification. Phase it. three next couple, in the the or as strategy they just dosing Thanks is is year there label? what But Phase to patterns. and inform to Botox injection a is initially were strategy there here? term to two aesthetic replicate trials the X longer I well is advance as know

Mark Foley

Yes.

there. question great So

of these nice obviously wait These duration thing the more trials, have we Phase X so that the studies, will acute read data, not will dosing. won't of whether after it's we strategy X X trials and at we injection out, of data efficacy the or that the dosing but top-level are we to we and inform And technique Phase time we think a on completion those. pattern I into X the on is timing facial Phase these evaluate study. have Phase then an the these will trials move we and will sort through not, as

Serge Belanger

But it's any squeeze I Okay. fillers. one will last the other of that the launch meeting? be data to next is be looking going sure we at should month. there TEOXANE am for one. is AAD the I

Mark Foley

Yes.

So launch not timing prepared date and we about to talk are yet.

thus You know, we said QX far.

you know, so launching in be And we some QX. will at point

to at I of it AAD, what to expect terms over Dustin. am else going to In turn

Dustin Sjuts

there think anything this is bringing be will new AAD don't time. to we I that

As relatively you is long. typically know, the lead those times meetings for

but meetings not And this so in we will be information likely new at year. other bringing AAD

Serge Belanger

you. Thank it. Got

Mark Foley

Thanks. Okay.

Operator

you. Thank

comes Wainwright. with question Tsao next HC Our from Douglas

now Your open. line is

line If muted, please your is unmute.

Jeanie Herbert

Hi Doug.

You there?

Operator

any I closing turn this am Foley remarks. showing the call like Mark time. to I over back questions not would now to at any further for

Mark Foley

Okay. operator. Thank you

Jeanie over months if Cowen, attendance several Needham also and include in to involves Los the out schedule the Barclays road healthcare conferences next Angeles, Please shows travel and York. and Midwest at would a would Our for the New when or to would I all are we thank in today's call. like to area you to participating like call. that, you meet your like With with if us you schedule in reach

Operator

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

You may now disconnect.

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