RVNC - Earnings call transcript Q1 2018 | Revance Therapeutics, Inc.

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Operator

Welcome to the Revance First Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today May 8, 2018. I would now like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Please go ahead.

Jeanie Herbert

Thank you, Andrew.

Joshi, call Dan Revance and Officer Browne; Officer, Silvernail; the Chief President Chief and on and Lauren Officer, Officer; & Executive Chief Abhay President us of today Chief Therapeutics. is from and Business Todd Aesthetics Joining Zavodnick, Operating Commercial Chief Financial Officer results Earlier financial first ended for today, Revance March quarter the released XX, XXXX.

the Investor do this would company's www.revance.com. like page added to If so the you to can you the or you've company's news not website list, release, Relations received of on distribution be at

product and will of on forward-looking to, company's we which During performance. of conference and XXXX of and technologies, the uncertainties uncertainties. risks current course and product prospects, approval, this risks significant to compete, future forward-looking to plans These candidates, and related including, benefits statements in regulatory call, and and financial the and candidates limited the Revance not obtain markets product management current clinical based development strategies regulatory expectations our make and in ability but inherently guidance, involve Revance's statements, future business statements candidates, goals, potential our are

Dan Form place and no reliance XX-Q you on to on forward-looking and And such the could Form XXXX. X, result with X-K. SEC for in entitled filed Factors Risk section undue Our on March XX-K reports quarterly the duty not or Form any current update ended the Factors cautions and on to Revance XXXX, expectations. statements describes statements undertakes reports timing anticipated of in subsequent cause its annual the different Dan? results company events these will our report changes the as obligation result or future call from forward-looking now of statements on could factors include December that statements materially actual the over turn from in as year those Browne. new I events in a these information, risks results uncertainties. forward-looking a differ of as and be to XX, to

Dan Browne

Thank quarter aesthetic is afternoon better as filing solid closer thank DaxibotulinumtoxinA for you, RTXXX. commercial first for for you Revance moving footing call. to Injection, our and first Jeanie. known our on product, and the Good joining BLA conference

We neurotoxin patent unparalleled deep stabilizing formation with peptide pipeline. have differentiated a clinical protection, unique RTXXX and and long-term highly neruomodulation a results

consistent The study lines databases in X two our catalysts XXXX remain duration to Phase for Our be on evaluated sites second covering safety X our glabellar North results America. on the open-label in of We in X one key year. file the study And than gathered believe if SAKURA at we XXXX. for will for obtain SAKURA results the more that label first over track X,XXX largest the the based safety approved, will on half trials pivotal of commercialized prominent of half in XX RTXXX patients RTXXX. We readout represent BLA in can of this years XXXX. strong X-month for

experience will once that in is and believe use physicians performance, and truly the matters. also We approved which patients what

of in the expected cervical severe clinical plus RTXXX the a in is based half the It of as trial the Canada, and from the year, initiate moderate the of is plan Phase change our the on study study of approximately versus will we sites second this to open-label States, of baseline. have to placebo. endpoint And subjects score same TWSTRS-Total pivotal primary commence include X dystonia. utilize an follow-on treatment Enrollment ASPEN In Phase the treatment two RTXXX. United total planter Phase one pain based expected with the milestone blinded, XX anticipated to on before at with expected safety initiation trial primary for be quarter. score. be the doses program placebo doses The XXX Our covering two this next major X will study fasciitis. to And of is of will be RTXXX for is BASS to a the controlled endpoint of end This X double Europe. utilizing to RTXXX

significant regulatory two indications. at April, neuromodulators, chronic in migraine. we paths. upper investor for date Both outlined indications limp As Adult for largest to and spasticity clinical RTXXX our have to the positive and RTXXX we're to our in with pipeline clinical the new day highly due neuroscience therapeutic results include opportunity and indications defined the expanding market

we high learnings a response promise the is In additional in bring RTXXX muscle migraine patients opportunity X in global hours for of relief of than progress. XX Migraines be dystonia in We leverage in limb the Phase undertook and neuromodulator the was disabling to more long-lasting of cervical limb case a grow. for this after per occur to use is continues more we $XXX initiate year. upper can neuroscience treatment cervical $X.X highly lasting typically spasticity four days goal study Adult chronic that dystonia the Our part indications. opportunity or Chronic rates neuromodulator can global in million past, our migraine and saw already upper in billion spasticity the treatments. believe of movement to is terms to these migraine month.

severity neuromodulators as frequency the migraine such of are aimed treatments and to reduce attacks. prophylactic Newer

injections have CGRPs a as X CGRPs XXXX. opportunity time and have neuromodulators RTXXX the For our regimen we plan sizeable therapy, Despite and regimen head to for with the patient study to emergence as neck different around commence observed treatment dystonia treatment can between a trial. migraine and Phase are very different neuromodulators Phase and expected longer the treatments and We we're a in cervical believe CGRPs coexist. we see new potential in potentially targeting fewer X economics. still of

XX million and alone. one sufferers with continue world grow of in to S. will We the migraine the in the migraine afflictions U. expect prevalent headache the as most market is

our and we With the RTXXX, X limb Mylan indications. chronic migraine, now collaboration biosimilar to includes Botox. pipeline with a with Along moving forward on addition of our upper are RTXXX spasticity

idle this next Mylan's experience allows intensely to development Revance R&D to quarter, monetize approval the utilize an partnership As generation recent pursue and and focused announced remain of launch we RTXXX pipeline. and the our on in highlights. while company in biosimilars covers continued asset All commercialization. first That the

quarter turn call to over the me Let to first summarize our Lauren Lauren? results.

Lauren Silvernail

first ended Thank balance our you, the investments Dan. Starting million. with $XXX cash with we quarter

development collaboration first the quarter $XX.XX was quarter cash million XXXX Our The Mylan first cash on $XX of quarters, we the issued in call. a by earnings we receipt expect Today in we offset upfront upfront Mylan we the in Revenue our of the of for our recognize recognized through release million consisted we from this program. payment. XXXX $XX.X million details XXXX our today the the of In payment resulting net from financial for will as go so quarter. are $XXX,XXX guidance. burn detail the future reiterating biosimilar I results, not advance the revenue burn will additional

$XXX We cash excluding expect million our $XX in to to Mylan. of from be the received burn the million for million, $XXX XXXX range

cost XXXX, our operations were March with of through in shares turn And for to Dan. We cash migraine. Revance's our upper and the $XX.X This fund and to includes late that, start call guidance XXXX. XXXX continue outstanding to we as XX, investments approximately for spasticity XXXX of intend in new back million. expect neuroscience I'll trials chronic to the

Dan Browne

At day Lauren. month, you, supporting shared the we our Thank and science, nonclinical investor last our clinical data.

and launch preparations. pipeline velocity clinical expanded product our Our

and go neuromodulator formulation we at look to unique our As strategy. market

regimen could annual with response In today, is that We physicians from delivered the have RTXXX next-generation lure that results hired from make therapeutics current high from from into outcomes and the moving differentiation our The correction better long-lasting for Duration satisfaction translate results. patients of we indicated update. patients. to we're recognize take They this strategies treatment year the months made aesthetic to sales with Both believe next leadership line real publications others homerun marketing rates commercial fillers drive to where RTXXX make over a at the physicians patients And data a plan higher care and neuromodulator RTXXX and of and our Six market We six twice getting clinical in truly where try building we XXXX medical clear far to our can patients least and neuromodulator away has and around confidence this indications major today source and their months entice and duration recently We We're cervical throughout physicians our have well to recognized brand aesthetic response period. future. is That's finalize enter with but a brand frown about believe of share longer a data. to could extraordinary. quarter's in patient all improved studies dystonia can very and a thus for generation company time. and clinical in a we frown lines first The cervical significant to we for coordination excited awareness can be a and SAKURA to desired. RTXXX the dystonia. strength. are the highly challenging, neuromodulator entrance truly like We've carried successfully is longer at the high-performance RTXXX's pharmacoeconomics. position for along our patient clinical adoption. matters. raise continue to conferences market awareness and

Securities and you the joining we at Healthcare Aesthetics the up of that, the In June, We seeing Conferences, attend to Conference those now open our Blair you Conference. Goldman in terms today. Jefferies one will Cantor we and I and thank for questions. forward With Dermatology all to Sachs look plan events. Science schedule, Summit, Life for us travel Growth, plan Healthcare, William Operator? J&P at In May. to be Healthcare of the UBS plus

Operator

from Instructions] you. first with our [Operator line And question Lugo Tim of comes the Blair. William Thank

now open. is line Your

Tim Lugo

or there are into Thanks you talk to taking going about dosing? I of question. XX-week be can dosing Conference I end least or will number that have well? the belief week KOLs towards guess you XX-week Daxi for date, to duration trial XX efficacy as of We've a AAN the the dosing to terms for in and given to and next schedule to seems migraine. wanes you're of X look of And the assume the like a my push a at going schedule months what around data maybe a Botox spoke the in

Dan Browne

I'm Hi, This that to Dan. is Tim. going comment. Abhay over for a turn to

Abhay Joshi

here. Abhay Tim, thanks.

So, duration get we RTXXX, in at data with similar comparison definitely when that have a know you XX we CD. least as where compare use dystonia when cervical you you XX-weeks our And weeks.

about for XX-week expect the we based So, But the that current duration. calls same on migraine. analogy, for regimen

as XX that duration expect CD weeks. program we'll We for get similar about get we in

terms quite design, but In actual a the give details will migraine good and we will we of well. in as trial that confident to I program, longer feel ability have much have highlights when duration RTXXX start more you

Tim Lugo

with in for as to what is were know as are U. there Okay, Will general just differentiated, the market? broader some Todd, there maybe brand the for kind neurotoxin some a like? there experience looking back about know previous be comparison six question, useful XXXX? of S. looks Asia. many time, we �� three looking Conference a discussions the continue had around the out of market. around it could should obviously into of lot I a think in you market to S. that AFPF we've I U. but be How looking players three you're players, given forward commodification And in but a have Obviously, the the XXXX. that

Todd Zavodnick

X-month in Todd. just it there players. have that You answer Tim, two mean right short right? Hi, you way. the share. day, anything market Dysport take the Xeomin been underpenetrated. been know it's is now all to beautifully. order I came neuromodulators. It's at in hasn't players discounting and there's new, market following of second think They're been the And the end acting the third and And started I like it would I three

come, look of there generics So, scheduled. to today, at going be but scheduled category players they're short-acting that I the are when into the market. to going come to they'll we sort there be are I think branded And when or don't are know

leader at I So, But the you'll see share. based business market I the based leader per off you discounts market continue science day, what and outcomes, off the of end think and sort off quality, piece. think see of the relationship to a is remains based

of the then And commoditization entrance majority category have or would have And just discounting If share don't. two the worked, today. so, discounting market they newest the would older entrance the share. most two hasn't the of the driven in short-acting or

to analogy think innovation. much his what think it I is wants. pretty see everybody you're Dan injected duration to now. align with true going us is what year. with patients coming fillers. RTXXX come year in true. said simply of with isn't the is is It's their majority just this in patients of less going going And to us And this a twice opening a are twice just are And where I getting in They're

Tim. So, going there's I commoditization, think be don't to a

you're with and Dysport Xeomin. think the now seeing discount I

education. I I the market in down more think players think think more be awareness is I to and come do it's to there going to going But And noise. innovation. the the more

the the So, penetration hopefully that overall market. raises of

Tim Lugo

Great. Thank you.

Operator

question Cantor next line comes the And our Chen Thank Fitzgerald. from of with Louise you.

now line is Your open.

Jennifer Kim

question. Louise. I on a of Jennifer for thanks taking Hi, couple for my Kim This have questions. is

any those of the that few compound So, first, trial? this and fasciitis, can new cost trial on trials, cash think your color what specifically, you upcoming second, design we X how as placebo confidence provide placebo drove And the Thanks. over And trial high give bit the then gave how high won't indications, could Phase the just planter about burn results upcoming the color announced more previous recently well? in years? rates on you study for you rate you think in might your those on next the a more

Abhay Joshi

[Jennifer], (sic) take planter I'll fasciitis. first Abhay. this [ph] the is the Louise question Yes,

we also we discussed Day and we in data X-week the as the what Investor saw versus seeing So, X-week are we about the that placebo XX-week talked at much data analysis. how pretty comparing

So, in learned the failures is have a separates our what the whole XA trial Phase planned trial earlier program. lot current from we from the older

treatment paradigm. will the we the doses. As the And those injecting talk a sometime definitely you clearly will program this mostly second we half details And XB different announcing of on. with product two as those doses we're be as again, the we later discussed, Phase But of details we've the very it details see of been the announce in doing two year. about program around

Dan Browne

table the higher that there We also those than some noise. trial. can at at There's new contributed the slide look will some one of of where trial that captured you in Day differences on expected Lauren, you Investor previous thought a want to the the that areas placebo we in highlight to those do to take cash?

Lauren Silvernail

Absolutely.

Jennifer Kim

cost. And

Lauren Silvernail

cash and Thanks on the for cost. question

guidance R&D about million. this So, with regard our to R&D year, our for XX to GAAP $XXX expense is

two and significant which the work BLA. So, by study is and second ready that. preparatory file is the of that XXXX a GL CD. half to Along to our driven Planter burn. to lower really part in smaller fasciitis it's really studies, the is And all get contributor a with in the is

we'll be are beginning cervical next chronic our big the the of of work driver will at early But by the year. study next look we guidance For some followed in and we where migraine year ULS. XXXX, give the dystonia when at

our the changed haven't year as indications were and all start at we XXXX guidance planning for new to XXXX. in We

we our a anticipate bit fully and will So, through cash last little further. XXXX possibly

Jennifer Kim

Thank you.

Operator

line Thank question you. Barclays. comes Morgan Williams of from with our the next And

is now line open. Your

Morgan Williams

taking thank the for questions. Hi, you

just if and looking end six claim from that chronic you requirements FDA, in in what label patented label interactions your you you to the to what first then kind know, get get fewer of demonstrate. of points noted the can guess order So, outline for just also terms a I pattern. And to need wondering injection with exactly to months similar they're you're the of in looking terms looking you're and on to that do I'm Dan, I on migraine Botox? secondly, that

Dan Browne

to want the you Abhay, one. take first

Abhay Joshi

I'll the first question. on the So, question take label

FDA key with define your looks as or endpoint discussion last is and factors So, pre-specified X in the you your label. month FDA. that a Number protocol our we in there X are approximately one, for when discussed

important. that's So very

a meaningful your product. that also factor you'll your it's And about in the all duration get is It's how is. data upon agreeing for what and relevance clinical Secondly, big equally the note precedent I for what XXXX. in to it's as label has to got that draft important And us, think came get before approval. that company guidance the important you the

XXXX. And label to labels. likely for labels after but So, how granted also and the important own is, feel data not labeling after can similar where data. standardization labels probability claims the subsequent a the they format with of that's product the that, what respect the key at And on look to very with duration FDA question fairly for in keep that were say grants label factor based is interaction so those getting I feasible. least fair the us sponsor similar is And and X-month course, talked we we our indications to definitely of are that have very the of equal confident of last terms There's track of for FDA. about the on data

Dan Browne

I'll pick headache. the on chronic on up Morgan, the question migraine

I has is We drug aesthetic and proprietary, establish over of property the believe a and been formulation think very product. the key therapeutic just position our an indications. opportunity that stabilizing intellectual peptide beyond the there expansive to neuromodulator do portfolio both

after label that question. tolerability injections Abhay so, XX on the the And that in to we'll of XXXX, reduced addressed also areas IP improve the from to work work with starting that previous be potentially go today. duration with to the strengthening longer But number

So, that us be competitive additional and that will give proprietary we think advantage.

Morgan Williams

the Okay, for question. great. you Thank taking

Operator

Cowen. from Maughan comes line question next with of Thank you. the our And Bill

line now open. Your is

Bill Maughan

you for gating still that the or other for any there's BLA. be but besides follow-up, factors maybe the was whether something wondering on if long-term we're I us could else waiting or afternoon. just safety factor? the just the how a I manufacturing commercialization? of Good potential know not refresh of ex-U. second think big able question, a compilation the then is And Thank to would be might for S. BLA actual that universe who partners RTXXX in of you. support you limiting properly the terms

Abhay Joshi

Great, is again. so Abhay this

regards CMC the go I what other the intersections. if be BLA is back are largest two mean to One to submitted with you the and clinical section So, section. will filing,

since of duration that open-label So, a mentioned safety study the of in for durations as end to we working of that this news safety parallel will is that longer long product we I take with for that, the as study. clinical nonclinical. section, Dan toward wait and so the the the And we have as we'll are to the conducted the other news have good sections patient have think and bad open-label CMC exit year. the After our

So, XXXX will filed all the the converge in time the of first [ph]. those to at right half BLA have

Dan Browne

as molecule grow neuromodulators across Bill, therapeutic. these a to and aesthetic both continue the

XX% for both. partners think is the side. on muscle headache. U. neurosciences that billion for But the potential indications. that migraine therapeutic XX% is pool know vast We you've there think the aesthetic roughly Particularly around potential S. therapeutic number and for in threshold of got the significant the $X outside identified initially on partners You on chronic the now. areas rest a aesthetic of we've are in movement Approximately we those

have we're of going to good ideal get is development closer we in choice choices very going conditions think as geography. that some as that commercialization. business partner the those look to at Our task forward for a to we And

Lauren Silvernail

right? now $X few There in this neuromodulators. Lauren this is is Silvernail. in are size, market is the very today Which Bill, billion what assets

folks with And nice potential a with. product can so, list multi-billion-dollar our of when partner we it's we look at

Bill Maughan

Thank very Okay. much. you

Operator

comes next the our Thank David with Piper And Jaffrey. Amsellem of question line you. from

now to is me Your mute want Pardon David, line check if open. your you button.

comes next line of Okay. And with question from our Serge Belanger the Needham.

Your line is open. now

Morgan McCarthy

this or of anything. sorry up McCarthy take trial those recruit? follow long Morgan is kind guys a first year SAKURA the as for X ASPEN of second I then Phase X program taking part the of have later what in patients cervical question will And should half? you for any Thanks the the on we [ph] readout do the is, question question to This the And Hi. My will missed is open results expect you second in my for label Thank XXXX? in how XXXX Serge. if think then you. efficacy be topline idea endpoints and dystonia, that

Abhay Joshi

for So, as there long quarter duration? and Dan think the are I asked. will One mentioned. end about, time does how was be that two so recruitment take of Great, the starting questions some you program this our we CD it the

patients So, in will based strong question get of It XXX roughly given XX the on recruit And pretty it take total. was months. program. number we feel whole past that about we would the about done to the about? months to like recruit our XX us in we first experience can And

Dan Browne

SAKURA X with [ph]. respect

Abhay Joshi

study. and an that's X,XXX patients. cycle treatment so who open-label strong It's patients X, SAKURA to single receive includes the a That cycle. now and multiple safety database over treatments,

that believe output in RTXXX a part of largest DaxibotulinumtoxinA multiple injection So, cycle. that we would treatment or on an single as the safety a of the be the

Morgan McCarthy

you. Thank

Operator

Amsellem Thank you. from next our the Piper [Operator line David question with of Instructions] Jaffray. comes And

now Your line is open.

David Amsellem

get process joining this, some additional may your thought and apologize I color to for but I just in wanted have Thanks, here. missed on so late, migraine

understand trial Study. to Thanks. to there. extent pivotal get we it to how So, CGRPs if you're to safe pick what prophylaxis is, the with study head-to-head wanted One then pivotal like help similar your BELMONT placebo-controlled going designs market I your be the program? secondly, on a then really And sort of go you to brain it'll evolving the it do So, sounds questions. the is you did But does with be guess market? standard And it doing just to us two see migraine that. say trial, on the

Dan Browne

you this chat good with again. It's David is to Dan.

rigorously spasticity, data of very which plethora forward gave I selection that very And go think markets could I a the to on take largest think few led it our was through us we strong over very the indications process, alternatives. challenge positive the potential and is CD this and that validated therapeutic on thoughtfully move last a to the based that us there of differentiation. year

think at look and at on Based products headache, data we not new the the opportunity, and but of key co-exist. both on think the the assessment there's I to leaders chronic of our opportunity both only [ph]. opinion look we the current for migraine an emergence had CGRPs clinical them to the

year of our the I is longer. weeks are we mechanistically And think more now think muscular an dropping opportunity weeks improve as as we'll XX know We and to CGRP number is XX XX neuroscience, off or on ability certainly those end with the an a of tolerability. neuromodulators mechanisms. think work well by the the extend this to where there readouts. think the to there's But I shoulders at the opportunity

sort those So, than treatment patients. as bundle ability what both date. and in have looking this the certainly An gave treating of we we on for could that headache, little and to been at something take new prophylactic confidence look us done a chronic that we further And that's it was a alternative and migraine acute forward to of thought unique what's chronic. move

David Amsellem

studies? pivotal then And

Dan Browne

pivotal we're as those designs. looking studies, at far As

commented some comparative a placebo-controlled active would type, type haven't We be that trial. whether of or

that one the go of starting sites poses until treatment adequately we're we're and at not looking reasons Until you're part if different of through we can that at process. some But looking injection patterns, challenges. XXXX. it critically. very think different that It's I

we'll So, to we we'll patients. come you tuned continue start ask stay back dosing and once to

David Amsellem

Thank Okay. Dan. you,

Operator

the Thank you. question And with our comes Difei line of Mizuho from next Securities. Yang

Your line is now open.

Unidentified Analyst

migraine. Difei. is neuromodulators I on could the you taking for was guys. you. one perspective economics Thank question. about if afternoon you wondering from in on CGRPs. physician's had talk the chronic good Hi, versus difference This for Alex Thank I a with

Abhay Joshi

oral in forehead around speaking, are XX think you about is every This of – by benefit differentiation in simply know, you What from head. administered. treatment they're look think the or giving not that the can general, these it these SubQ as product paradigm at your the comes monthly, quarterly, not duration. inject CGRPs, you or Botox so and I injecting because economics When is terms even are daily. oral, I XX around because not And neuromodulators more well if there's know treatment at for IV you we to talk how far And They're more sites weeks know you economical Broadly convenient. some get again. they effective. the are very Abhay IV,

what overall even increase to is happen to though XX% the respond about only CGRPs. pool, So, you'll but will expected are patient total

we in comment best other but have of cannot on neuromodulators for economics, are will than pricing, I probably companies the So, approach used certainly think to different way as terms who structure. the what are companies this commented be And is for. the CGRPs pursuing pricing the

Unidentified Analyst

Thank you. Great.

Operator

questions time. further no showing at I'm And you. this Thank

for joining wonderful all may I thank today's disconnect. you Have like would a conference. to And day. everyone that, with So,

Revance Therapeutics (RVNC) 12 May 182018 Q1 Earnings call transcript