RVNC - Earnings call transcript Q3 2021 | Revance Therapeutics, Inc.

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Operator

Welcome to Revance Therapeutics Third Quarter 2021 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, 9th of November 2021. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG of Revance. Please go ahead.

Jessica Serra

Thank you, Laurie.

of call President, Revance, Officer, Dustin and Vice the Officer, Chief Toby on Rubio. Senior Foley; Roman Mark Sjuts; President us today are from Executive Schilke; Joining Development, Clinical Chief Financial

During this forward-looking FDA; statements a for guidance; revenue Type of to preservation revenue A remediate our related FDA financial product regarding our safety, Injection the the rate; for timing identified based the worth will products in are commercialization and our potential performance, the and and market opportunity of deficiencies statements, ability therapeutic approval indications; benefits duration including risks therapeutics processing the with statements approval clinical call, performance forward-looking strategic potential involve market and our services; Injection; development of and services; current expected industries. the These run inherently aesthetics and volume drug candidates; and our and conference commercial BLA; plans; management make our cash candidates and DaxibotulinumtoxinA technologies; DaxibotulinumtoxinA glabellar meeting by success runway; and priorities lines expectations uncertainties. to the and plans; potential significant and strategy; financial and the of and products efficacy for company's operations; on and the and of product our planned business our of our demand cash

will timing earnings the With of is Also these reconciliation forward-looking uncertainties. the to could of risks Foley. and call such included of we Mark? that, statements those measures. today's I results GAAP actual both in result to non-GAAP A turn present GAAP non-GAAP in call, over on Mark will financial materially a measures release. Our our events and differ from as anticipated and

Mark Foley

financial quarter Thank call. our you, results thanks afternoon, XXXX everyone, for Good third Jessica. conference and joining

study III in for from I'd for update positive our Before DaxibotulinumtoxinA quarter third and the provide lines. review an Phase we cover our Injection like our to glabellar performance ASPEN-OLS results on cervical for for the BLA dystonia,

you facility. most deficiencies our from on-site of application has disappointed inability understand are CRL to a stakeholders. and present due to to very manufacturing the the FDA of October our received of citing As on aware, BLA their approve form frustrating our related in XX, we FDA's We're its continued by obviously for inspection also the delay of all been that our response the

soon ever that you is get assure Revance the as possible. as determined our as can I approved product However, to team as entire neuromodulator

preparing request the We the inform are to for clarity briefing working A approval alignment was FDA CRL, that a Report, on our our are following provided Establishment the by for information Inspection book including the meeting submission. needed and Type incorporating currently on and our additional to requirements gain

this parameters million of $XX a are A run inappropriate us as we our million a of over a already and months pushed comment Despite beyond Type engagement We to safely delivered and agency, injectors was rate our process communicated where with for we've we trained SA. Given have working pending the until the in TEOXANE it meeting. launch is what pathway not delay approval. to very XXXX. X experienced Recall last launch commercial first look have delay. forward an rollout update our from we COVID-induced the partner, of on we under to over to XXX time RHA and once the This in supply confirmation XX onboarded its chain months reps, that constraints back limited year, and revenue is first successful the sales the our that we've due generated providing QX of $XX pandemic,

past the the I'm Looking as made of X tremendous an over we've organization proud years. progress back,

for BLA our First glabellar and our foremost, DaxibotulinumtoxinA lead we for Injection lines. for product, in aesthetics, submitted

billion also a rights OPUL in product and line exclusive TEOXANE's the upper completed lines, with built facial of of our RHA We opportunity we executed muscle our across II dystonia strong therapeutics, Phase long-acting in of our secured opportunity successfully about and therapeutics. of XX% distribution the our Phase ASPEN the neuromodulator in arms Collectively, clinical movement III the cervical upper disorder program the in the muscle III stands HintMD drug trial the U.S., completion in for at infrastructure. for launched our successful acquired treating our Injection of company's validated and supporting performance opportunity Phase the the The aesthetics trials program fillers successfully DaxibotulinumtoxinA U.S. movement commercial spasticity. program Phase second in profile that for program for differentiated neuromodulator In is $X.X disorders dystonia II for limb currently worldwide, cervical market in the for completion our of clinical and treatment and out

to need franchises. position milestones within therapeutics and consumers. strong the us be our remains patients unmet put simply, for these neuromodulator and aesthetics To long-acting it for continues to a an opportunity meaningful value of create and All

We continue announcing strategic In based is our said, agency's while product, were inspection the manufacturing priorities our during the clinical in or cited made I'd our and anticipated limited words, related forward changes. like of to data CRL That believe the to to outline product other package on-site our also CRL, deficiencies facility. some going organizational to label. the not our related the on observations approvability of

increase in to FDA expand market continue our one U.S. cultivate and our dermal platform. number Injection obtain Collection. RHA lasting billion our number filler is OPUL, relationships approval priority customer is and three possible. as $X.X for deep to glabellar Our with for DaxibotulinumtoxinA for And lines is the to through as soon revenue two strategic fintech to Number

Injection. these my financial the more line aligning to direct our call. Sjuts, cash preserving our optimize Toby Dustin Dustin of we for to I pleased for change Further, strategy was enhance in with DaxibotulinumtoxinA align performance the Revance's will Dustin the have to organization allows specifics our who reports President enhance building capital for our our as structure me HintMD, positions our leadership. personal we President I'm performance. to performance developing his all the priorities reflects promotion our announce in oversight in and commercializing and confidence of later quarter. performance, addition the In allocation to our change BLA initiatives of on and He over promotion and instrumental This also in priorities, commercial Chief will In the will will of be integrating our with to aesthetics assume and Dustin? His order successfully this allocation capital and exceptional organization. call to flexibility. efforts for an to facilitate streamline to the strong Revance. better strategy, Dustin's our cover aspects experience and be that, let Officer, to background Commercial cover turn continue invaluable the strategic team portfolio. me With for to resources,

Dustin Sjuts

Thank you, Mark.

neuromodulator the -- years none the by the serve growth. say Revance. come me across of foundation comments, place remains honored to In to our organization, would The therapeutics. both to I'm by neuromodulator my programs our President clinical aesthetics overseeing To higher in we've realize this X over people of their show possible to Mark's let And by existing without as for to with have of departments doses been believe the a years that potential formulations. we laying durations right and and for I echo extended saying operations, initiated our the is continue peers way vision, recent have interfacing that First, robust, long-lasting across commercial market demand strategy in supported with team. past and attempt long

of a as upper effect certain therapeutic lines, cervical data our a patients. have Our aesthetic peptide clinical new months indications formulation a and product only X the on dystonia long for in with what's Injection canthal demonstrated showed a long and duration profile all in addition XX-unit X dose DaxibotulinumtoxinA for a strong In SAKURA up of proprietary our safety upper and lines today. formulation uniquely lines, limb It's consistently and facial and clinical Further, lines profile. available data is the glabellar with median duration indications lateral in for spasticity forehead from different efficacy. to as neuromodulator duration well of market demonstrating studies, to months

we believe Injection date. is For DaxibotulinumtoxinA these for most reasons, the to formulation differentiated neuromodulator potential

the RHA for third slower addition period. accounts well results. accounts. revenue existing $XX.X X.X% quarter increase by the as Total from Turning a despite as to QX new of was higher driven sales million, Growth our a over was

During the our bringing total and XXX we accounts X,XXX. quarter, accounts our RHA over fintech across aesthetic platform, to added over

we're the the its most RHA modified strong to holiday the Looking filler the ahead overall built market, a commercial we with we X It's year is launch hyaluronic acid product given thus ago, heading be today, strength have differentiated least continued expect line. QX proving and in Since the season. into the Collection and a the far. seasonally and pleased dermal traction valuable on natural market and

OPUL, the Our for the with we franchise exciting cross-selling over piece adds aesthetics the and Relational RHA, prestige once for in for customer our which Commerce Injection operating turn on commercial can to aesthetic the leverage vertical, base that directly opportunities foundation for our serve believe time. team focused platform portfolio. commercial is realize expanding significant approved. will as DaxibotulinumtoxinA another We first

their OPUL way complement that to true believe attract practice their owners equips our fintech customers to retain first-of-its-kind transform to a the only better help a we believed to practice platform and a them product develop to long support best growth. We customers. us better also partner consumer experiences. help data can its but physician technology have not and offering ability is be to patient from a It's leverages that that build and loyalty. It stronger the relationship build has platform transactions with

a card OPUL north Over the In payment and in opportunity $XX represent the of to market. And as can helping with addition processing billion chain. can of platform aesthetics substantial the revenue provides value U.S. participate deep we $XXX time, create the million. capture customer us relationships, a registered to processing payback, credit believe more now lasting opportunity us this

quarter, maintained third despite payment the of processing over During rate slower billion $X.X a run we traditionally season. volume a

Looking very penetration, account OPUL. and believe growth. new significant We'll through a ahead, focused HintMD in on for has be migration customer completing we building runway features OPUL

the III line Phase positive share therapeutics. study top to to results I'd ASPEN-OLS dystonia. our from for like cervical Turning

reminder, rolled multicenter an dystonia Phase ASPEN-OLS trial a and a of was October to DaxibotulinumtoxinA X study. was XX% of and successfully the for XXX study. over the from treatment of consists evaluating with treatment enrolled of units. efficacy dystonia. in XXX, the XXX, DaxibotulinumtoxinA X Injections safety and study or cervical subjects, was ASPEN-OLS evaluated over to ASPEN-X long-term which pivotal repeat of for III total open-label adults the study up open-label, doses cervical a our the receive and safety treatments in approximately XXX ASPEN-X XXXX. XXX trials: of could the ASPEN-X completed the Injection evaluate a period, of As Subjects included program for of The XX-week

are per in at were dose-dependent X.X% adverse events on for DaxibotulinumtoxinA found treatment and to no that Injection well injection increases serious as X.X%. There demonstrated generally dysphagia treatment. pleased a well and be most events as adverse X.X%. doses study safe at repeat at treatment-related across site weakness muscular adverse the was with tolerated treatment-related were We events. all report The pain to common basis effective or

profile the XX.X ASPEN-X duration that to efficacy of the as the time efficacy reach target effect ASPEN-OLS within We duration doses In with XX of treatment in consistent across from by to the TWSTRS effect, in study, weeks XX study to XXX units. observed pleased ASPEN-X the ASPEN-OLS see weeks evaluable score, are units cycles. was XXX and duration ranged median to data XX the Comparatively, results study. observed median defined and in the is weeks for

adults effect ASPEN-X Given dosing for data dystonia to Toby in from duration efficacy path our to DaxibotulinumtoxinA spasticity upper assess for this promising dose-ranging is patient. treatment study different lines. I'll physicians program with can categories. profile, the In clinical treatment to cervical our following best across way long We'll approval glabellar be successfully can that our be option optimize we Injection and believe condition. especially strategy program advance third help the With compelling vary with the safety, of X treatment for second on completed a for III limb the -- the DaxibotulinumtoxinA can new each with and for continue opportunity can plans and believe clarity turn Phase we our the the treatment patients, the since over cover from financials. particular, that, BLA call promising FDA to quarter Injection

Toby Schilke

million $X.X from partnership our included Collection, was with quarter, Total $X.X million the RHA and Viatris million third biosimilar platform. Dustin. which our million for revenue on from $XX.X from to the Thanks, $XX.X our BOTOX fintech

to related to general compensation. amortization for expenses Injection. third Turning for Selling, expenses. expenses $XX.X included and our pre-commercial stock-based for administrative million. the marketing SG&A activities expenses and included and DaxibotulinumtoxinA primarily This quarter RHA operating were depreciation, sales and

SG&A compensation. million and quarter, were development pre-commercial reflecting $XX.X development. included stock-based and ongoing expenses non-GAAP expenses platform Research activities support amortization the trials, regulatory R&D and expenses expenses, and these our Excluding to third $XX.X were fintech costs quality BLA, for related clinical for manufacturing and million. depreciation

October million, shares Revance's of shares XX.X and XXXX, debt. common Excluding investments expenses excluding impact convertible XX.X these were expenses, fully of XX, non-GAAP cash were as outstanding equivalents the R&D stock million short-term September with $XX.X XXXX, as XX, million. million. of approximately $XXX.X of Cash, were diluted

like prudent to I'd priorities runway. allocation and we our are review measures our extend Now capital cash to the taking

Dustin are As OPUL. for deferring pausing Injection this pipeline spasticity DaxibotulinumtoxinA from regulatory China. our expanding commercial believe exception our investments but clinical noncritical and as received Fosun and focused of in cash commercial through DaxibotulinumtoxinA proactive limb a and relationships obtaining on include FDA, with not program well activities the upper Injection driving RHA in III XXXX. stated The for Mark and for collaboration we mentioned, We hires, our of the CRL other pausing DaxibotulinumtoxinA we enhance Phase Injection, for of FDA into deepening flexibility. our to cash limited for investments adoption and with financial momentum our previously for of and as time cash the Due maintain therapeutic are greater our which approval XXXX, to are we will customer to FDA withdrawing guidance assumed approval strong are preserve steps this taking at international

committed Following our guidance provide our and cash preserve that Type on and A XXXX upon to and to operating plan approval -- profile that, meeting with with important, also to the like underscoring non-GAAP while expense Injection. to expect franchise business to them be remain over DaxibotulinumtoxinA therapeutics clinical term for have accumulated, we cash I'd the the clarity updated emphasize for back temporary. building given Mark. differentiated we our our guidance. our particularly the We strong measures pathway, call performance we of and turn gaining long are And to our data agency an I'll GAAP

Mark Foley

ASPEN treat $XXX approval III the U.S. Thank QX commercial cervical to you, We're very Toby. seasonality. our we the on of top our our advance a our with impact the a north In opportunity to closing, obtaining base clinical strategy dystonia priority. market therapeutics near FDA program, also and In Phase potential completion in million term, our delivered the representing of in despite of executed strong pleased business is

are have we open meeting on briefing provide for With Operator? up we'll confirmation that, will Type an the we and request, path update preparing speak, I A a forward. the once call As now we our book for questions.

Operator

[Operator from first Instructions] Cacciatore Cowen Ken our is of and And Company. question

Ken Cacciatore

now team, asked Mark around know indicated you of the question little all received being it, the when for. lack I Report. that and have things you know different there bit Inspection CRL. were the of I was Establishment clarity a into a you

here? folks any and now about you been working clarity. discomfort is that the the that? more changed comfort with, it talk comfortable and fairly secondly, that then folks, you've folks feel any both provided or you that externally, internally that just brought Are expertise through helping you you if And Or navigate wondering all? So you can you've at provide with same after in? it seen Does you more you've there consulting Have who's with have process? the

Mark Foley

Thanks, Ken.

our XXX So sufficient we which on indicated the prior A the And meeting, clarity we that requesting first, at to we're as a not was were CRL, Type to going be the exactly mentioned or the on no of time that there that to sufficient. CRL, received at time clarity the we the guide we prepared to request. the gain from in of to agency A on remarks agency, commented we hoping additional have EIR which additional and is Type our before the submission meeting as received from the sort feedback Subsequently, request. filing Type that the meeting responses going A of

is to this getting those to feel to plan like and play-by-play continue going target Type anything. provide responses. the a We we're meeting responses color sort We XXX. get from the more of We're more agency, of good sort time. with to the really us the of provided that surmising about This the will clarity we not agency. point At we'll that point, allow feel do we at get more A where into and to into context the

it, the provided with good On that that that really the consultant of agency frankly, we along from have communication surprised off, didn't to we any We XXX. side the journey. were, feel, the first responses we

the And was disappointing so response and XXX our in surprising. CRL responses receiving to

information journey are in make to and this benefit importance best Given of along the certainly experts sure that the we out that's and sort continue used the and of product way getting experts however, possible, sought information that we've of external we BLA our out entire additional advisers the soon on getting market to the the the as have latest there. that, along as leverage

Type this as product of try with market meeting A again, is at all us this information, different soon priority. the our number and our again, additional as it's sort avenues And one so to to possible. onto looking And We're refine get request. allowed

Operator

from Sandler. next Amsellem question Piper David of our is And

David Amsellem

path couple a the the and forward here. just on So CRL

to action year delayed constraints. FDA for almost due was essentially the a pandemic-related So

extent turnaround where what maybe that cetera, an to of consultants, internal will, point with or one. in can number kind this, sense the calculation you to sort your these time? go you And the get in if regarding need your a FDA their have going to back are of pandemic you that, any of maybe number in of A might way And And thoughts you have facility all you maybe the now is spend as two wanted feedback that's answer the that? been So that's -- assuming there? meeting, least qualitatively any past? And is the the the to your kind that go just I consideration should do a of a we answer additional do just help terms et into then have what how spend, a ask what has row So with a post-Type ducks but right is, you consultants, since about can agency you inspection, you, and think consultants, external into in understand at factor from constraints have processes to us to are don't to do manufacturing? to you know

Mark Foley

Sure.

on as path to David, desire clarity, the the sure forward the and from we're for being and that internally, pandemic, make listen, and impact any sort CRL can. your get I around we're trying the first, So transparent question we as and of even again,

given and clarity. we communicate, certainty what where with we we when communicate are, want do make to sure is I that we think

timing. we once is the not Again, able we'll get lay through clarity with to speculating further Obviously, and exactly that And take. to certainty it's what as will A sooner going more is the terms get in Type now, to believe of best going meeting. be there path we we this be clarity, whether way to the a And the be on we'd pandemic-related be so or issues forward that, lot out right better. think what to I a that can get

spend. It's out we side the with drive that of getting consultant about while to of OPUL talked to our approval. else, sort the adoption and spend on of continuing in platform delivering terms On revenue the it, of and being judicious RHA the we've and manufacturing everything priorities laid earlier

resource we we've the all continue make the so believe on those for to and plan momentum got not that in sure deliver priorities right we'll and company. of to appropriately And lose place, those we key

Operator

Seamus Guggenheim. from is of question next Fernandez our And

Seamus Fernandez

that, a quick is was year. sounds next there's for a your the It like fourth So just of of quarter how our But continued conviction couple opportunity also that continue be the there. to high to likely growth sense of wanted but sort was and CRL, RHA move forward just of positions. use get trajectory it the for ones. DAXI feel into a into some will the that fillers I'll key understanding beyond you

the penetration existing substantially way, after going part the is spend standard. I'm existing I second new have year the to out is the beyond practices limit next on practices? So your sure pullback the And of question goal RHA penetration as account really in of shape know the X,XXX? or a the to question But sort you're the accounts Or increase form? of that. really expand of does to is, any broaden number to to it that increase ability -- I the

Mark Foley

Sure.

and So jump maybe little Dustin context and I'll as let add well. color a maybe in

line. in short I with period think our strategy. mean quality of also getting product the And generated that's help revenue going it's we terms start launch gone. of the X which of good will the the We team I to still to has a think looking we're and validated We're commercial in growth. off, really saying of strategy incredibly the the first RHA pleased and RHA execution a time, how trajectory, let forward testament by well approved, the also me we've there forward. RHA out So

overall The continue market things. to couple be dynamics healthy. really a So of macro

engaging tends stronger to to think than That continues really We injectables. market. is be seasonally facial robust QX. a be consumer in So QX

lines, of for the of have got the the our competed a And little So if bit tailwinds, it, with you've then good. and sort which of time at look focus the neuromodulator. headwinds launch that's ongoing of product would on the RHA you side all on tailwinds

we'll drive that. continue So to

accounts, the third, in is or of talked which of mentioned, Seamus, number we into kind roughly XX,XXX category you the half As roughly those. market, of about said sort we'd of is going which prestige the which we've so, after the get top

kind that XXX roughly along So X,XXX adding accounts we're per of journey, quarter.

we a Countering do is ongoing there. little also obviously, our that penetration drive neuromodulator to So in bit we think accounts. that room still some will there's having know unlock a bag help opportunity that in

So that but of heading And again, tailwinds, got want to focus, a new we've you strong anything partnering we I are can if think, know, got headwinds, season. open. then we've I sort accounts neuromodulator, don't to it with we Dustin, And add the that. into

Dustin Sjuts

Just of things. a couple

spend consumers' I kind to to Rev those driving spend as the not we're Aesthetics an RHA focused some with in the and we're that of priorities, on line that account think that RHA able investing on we return. resonates those very make address account choking That question and out resources in that. lift get I the well. as have will things the highest adjustments beyond the well has we on We laid agnostic confident resonated. for strategic the of ensure on really strategy loyalty not feel and the

in continue growing drive think be markets So dermal fillers, to that very able we and good to we'll growth.

you get calls coming, coming, countless doctors like right time it's asking And -- we RHA. for from we for it's there. great to have as I when now, feel can can imagine. on to DAXI it'd this focus when DAXI be the is utilize already While demand

around So we strategy and we penetration. our both and feel use get RHA accounts to well momentum like with the as Revance grow OPUL started could new us aesthetics that as

Seamus Fernandez

strategy detailed that that with A meeting anticipating in time? updates? that think filing we in overall about perhaps points come sort Type the will how and for point Or the -- us discussion Will the update then filing come on And provide should manufacturing able alongside CRL, a just this to planned Great. CD the post-Type the later at in be the think year, you'll we XXXX? I were of a terms of when

Mark Foley

Seamus. Yes,

of So to the III just of we to completed to position in what 'XX. to in in be on Phase we've reset, now overall And the communicated certainly sort program in was able CD sort approvals file 'XX, are that. OLS a file 'XX, we program, that complete

all BLA along supplement to glabellar the file as strategy Our to lines was this a approval.

that and We that's prudent most the think continue to strategy approach.

lines the clarity most between I the to glabellar and update time Type we However, be our have on visibility. the of sBLA give filing the that indication, A think given more the approval meeting, again appropriate and linkage an after will will

Seamus Fernandez

a hearing Great. XX one lot the timing X of kind -- our visibility to final or understanding to at then actual question. about of we're the just timing on A it Any would request delays regulatory And then take and backlog. of the but be days itself? some get Type post FDA, that meeting weeks It was that probably actually the meeting,

clarity if to wanted to able that see was be of you on sort there Just might any general that, provide.

on. that outside getting even meeting be is this that investors questions possibility Just kind could we're end-of-QX of something the an from

Mark Foley

CRL previously a the that CRL, of refine wasn't request Yes, little in given we hoping earlier there received I'll Sure. back more clarity, the we'd which binder sort we get together. go what we of meeting the to specifics Again, we that question. put to any itself, indicated Ken's now when to bit kind have, were

and on clarity that pushed or communicate within our to Type gets on out. We're got review plan it's a A And clarity will got that are them that and once with Type scheduled scenarios to hopeful the XX days. Certainly meeting the A on stay could then meeting. So statutory a make sort track where granting Typically, with I'm are. know pandemic, get that, sure there And And to again, the of that is time decision we've target. for days we XX then guide lines that not. what we've filing. think we

Operator

And Stifel. our Annabel next of is Samimy question from

Nick Rubino

is This Nick for Annabel. Rubino on Congratulations, Dustin.

economics about So just know And change thinking this you around this now, the Did on a trends thoughts quick II see of practices the regimens that end-of-Phase how about in What meeting? And forward? one. in infringing terms around you dosing any the burner on marketplace meeting anything from the mentioned then the have kind for but going method? of do it's back towards double value I you're seen potentially DAXI's study JUNIPER utilizing the regimen just prop? competitors. you

Mark Foley

Sure.

So as if I dosing, double neuromodulator look further anything, it of think the opportunity. of we first at credentialing long-acting on sort

recognize But quickly I think pretty a coming a you reassuring about that to sort need time, talk wasn't that now narrative I in think need there point and it's back long market, starting if a to it's there the really where category. that was there see I want and long-acting competitors didn't think to real a people it. the go of in patients is

However, put these XX dosing market effort and and been lot has years, over performance. for been on different of into of to evaluating different a have ways the products trying characterize

there to looks match So until there's at going be duration a it, product. data and matched to that out to a the formulation, Phase hard efficacy profile continue true safety that III of our absence the differentiated the we in with think it's of

that. feel a to So we like on opportunity continue huge there's

that an of a with premium for a margin. a with start terms whereas conventional customers the the affordability sort will to do economics in you and to with practices of as talked we think work, to mentioned think bit up that's of get of past, to into think that make higher bump little I dosing, the a us against Certainly, TBD. start for But product our pay some economics. premium more getting of double And there's we and positioning, ability in the if short-acting You what's dosing neuromodulators, you that. we've the

On feedback end-of-Phase that we in the end-of-Phase ULS we from that meeting. received very encouraged agency program, the by are II the II

So we III now Phase that that forward indication. needed the have clarity will be move to program seek approval and for around ultimately to that

not of we program. once going filler we As in approval adoption do It's the that II therapeutics program into to RHA pause the Toby an we're activities our sort with mentioned a out we're position if. of remarks, the given look ongoing BLA, his feel again, is of of and in sort clarity the for the prioritize Phase But marketplace, again, products and we when. But around to we good to were meeting of And the the our pipeline the on OPUL need III of the sort getting very there. this we've a so. of will again, looking Phase that feel, III to sort agency, resume got line end-of-Phase

Nick Rubino

Like are seeing actually as people Great. far that versus a use? more you dosing, before? And opposed just quick used -- double now doing to it -- of in are commercial clarification, that as Or is you as market, more the generating the trends clinical seeing are increasing? being it just buzz it's

Dustin Sjuts

are it been actually these other obviously A We haven't This These seen and resonating. IITs have really Phase is IVs. Dustin. clinical of lot trials.

the points. necessarily rigor So of those end stringent the a not same with III as is Phase program

don't I generation, increased dosing profile to for price I really a for safety that novel try their but people practicality to to duration haven't is, of it there's seem efficacy. doesn't they do relates increasing think slightly try are to done concept half. to value manufacturers neuromodulator one that the it's the a data to If resonate. is also, on do cut never believe long-term that, in drive that to the any practitioners And kind trying as been that

have no, to seen of resonate we outside that not few publications. date, a So

Operator

from our And is question Divan next of Vamil Mizuho.

Vamil Divan

around anything a around Indicated quick couple kind specifically? in that I just you for of clarity specified of DAXI. as from And terms terms it or in a of any you EIR, clarifications Official of what sort So And guess, then more Action maybe of maybe Toby. there? saw sort one -- Was can or of Indicated Voluntary Action the just give

the of Just I of you're impacted as provide can making. in you of of next sort maybe we in be of know if quarters can just don't of the terms about models you we that there? just or some think terms sort position Viatris by impacts you about sort sort in of year for then about as your think how cash update SG&A, these you're any kind might that making, should that how first run of fourth for efforts talk of the rate of quarter just R&D, And terms spend our of couple collaboration changes and

Mark Foley

and take take let question. then Toby second I'll first Mark. one the your is this Vamil,

with believe understand full information. the yes, we agency Type additional got we're more commenting we've that, sure we to in the to that going provided So on I needed on clarity additional the request, meeting feel forward. need observations more we until for and the in going make terms be completely information Type got refine again, be -- But that A the going of really we've to actually, meeting we on not to the the Toby? that EIR, the XXX. what's desire we I get again, to A think specifics responses clarity We good about our

Toby Schilke

Viatris, for X that And we provided had we to clarity partnership that with trial collaboration We clinical what's needed believe that then meeting successful biosimilar conduct successful continue in around the that the regards have. again, and Type to to a to question BOTOX. a on

going So alongside invest R&D for XX-XX projected Recall a continue forward. of on was run spend share sort rates collaborations question to fourth cost and mix of Then we OpEx. forward the going Viatris. third is that that, your quarter will

for there had are think takes still we bit a will of of anticipated I inventory sort will capitalization -- and little be be quarter of manufacturing reduction we a costs on we year there fourth puts full the the where more that given of just the as little sort bit of approach DAXI. for

already Form makes that sufficient XX least to to we and filing filed runway, you we operations the preservation the [ph] months described XX-Q if at fund sort that peri we that resources. today offset sort to for concluded plan launch of And the resources sheet And of cash less guide for current launch then there, we where the our initiatives prepared remarks our financial in the SG&A that I'll DAXI balance we underway However, against cash our our have extend had just that will we assessed that sense. operating in on by Form be XX-Q.

Operator

Blair. we William question And from Instructions] of a Tim Lugo [Operator have

Tim Lugo

XXXX come had the The sequentially and DAXI, should all OPUL waiting quick at relatively on for hoping market halo Street if resolution guess, RHA kind a there for I DAXI whole game-planning you've the how effect also we're year, is to not that agency how DAXI the the few And of just for for expect a year? next that is but RHA extent Now out throughout that around approved? are know of grow Or and, is we're quarters? DAXI to the and it when will see I you

Mark Foley

Yes, Tim.

and that will OPUL, to come brand, focused continue were strategy, at you it, So how to too, fact positioned we that features. -- ability in first commercial off, that the the place, that our team penetration. is online on adoption continue pretty on recently X which RHA, infrastructure the feel target our we like the functionality we expect drive of market, start if the And we're the have we like in into that thinly we're look we very on continue of fact supporting and allow again, look with same to people the additional our that And we RHA sort market if to -- to commentary we we've turn largely to there, earlier payback that penetrated still fact integrated just drive the here, the and success or in independent us made the about to DAXI. we had the to you at dollars date the

so And once looks think continue on think I we both why like sort independent what their our own. we of obviously It's speculate can that of of to premature clarity to that A, runway of the ramp And growth these stand I and that's to better neuromodulator. want know, the what about we'll the on like. talk position specific that. around agency Dustin, you to if a in looks be the Type anything add from runway sort don't have

Dustin Sjuts

I a We've proposition think about The we market building been feel for continuing is RHA. value purposeful unique the characteristics grow. to of really good. standing

You the strategy than for have is technology different driving based see And pricing change us People are with of others other doesn't off practices manufacturers. DAXI. out different programs, artificially demand without coupons to coming is what That Rev getting are that their and because they choosing what they're RHA didn't buy from in price. than Aesthetics our today.

Of very about DAXI, feel as it forward look as strength of and agnostic DAXI. to good want having RHA and the course, OPUL we quickly we possible. We to

Tim Lugo

the what's relationship? with TEOXANE? update stock share of could there kind impact know with and the are the any general obviously, And the Is there price deal, kind there triggers that partnership weak been CRL. guess they is in And has stock of your could what -- -- I of hear. to that since status be I took the any extremely great around that -- there is the -- That's relationship?

Mark Foley

that periods there minimums are had, upfront of a X revenue been sort Tim. with XX-year stock a up the Yes, the was extend part it deal great deal made grant and around the in of There which overall XX. partner. sort distribution was to to the But X-year No, total for spend. they've U.S. in that ability we we of of a

we're continue how in feel to We the really marketplace. good performing about

able larger base to on brand, a focus our and we're the more to equity the So think our related time once the us approved. strong, of in over really will and if anything, get we nothing relationship But account to which in given neuromodulator, there's we benefit relationship resources delay perspective. continues focus a be ultimately building neuromodulator now the terms from

Operator

are Foley, Officer, Executive further the Mark now And will for I Chief to turn call this no time. over closing back his there questions at remarks.

Mark Foley

to to to attend With out Jessica we participating thank Sandler to the months, your all requests schedule meetings time. virtually plan for the like some in In like Piper free events Stifel operator. of health at welcome you you, Thank directly these Feel to We I you'd us. care today's that, call. reach conferences. and coming through if for would or

Operator

participating. And call. Thank this today's for conference concludes you

may now Goodbye. You disconnect.

Revance Therapeutics (RVNC) 10 Nov 212021 Q3 Earnings call transcript