RVNC - Earnings call transcript Q2 2022 | Revance Therapeutics, Inc.

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Operator

Welcome to the Revance Therapeutics Second Quarter 2022 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, August 9, 2022. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

Jessica Serra

Thank you, Bella.

call President, Revance, Financial Dustin Schilke. the Officer, Chief Officer, on Foley; Mark Sjuts; us today are from Executive Toby Joining and Chief

this therapeutic products for fact and DaxibotulinumtoxinA statements, Injection [ph] to make the During the lines of process indications for management open and for glabellar related Redensity in regulatory approval questions statements potential platform, to forward-looking potential and in call, conference indication, RHA including allocation will RHA our services, us, runway, opportunity, practices market our and performance, and planned and consumer guidance, our and business growth preferences, the XXXX operations of financial commercialization benefits to strategic patients priorities plans, revenue and expected cash plans. strategy, potential and our capital our

and anticipated statements Form timeliness the or from With turn today, call Factors of XXXX. Mark? information, duty over events a Mark undertakes no Executive Risk a its quarterly in update report August obligation the will in statements as on that materially statements differ new SEC be in the in XX-Q our to these section with Revance include or result any Chief Foley, Officer future to of X, that, forward-looking filed results I expectations. changes the as forward-looking different results these Revance. and to those result could from the of could factors Our risks uncertainties. describes Factors such actual company titled cause

Mark Foley

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

platform. results and also launch growth market. OPUL RHA of success in our across reflect quarter-to-date account injectables the the the solid resilience and We’re second These very continued commerce facial quarter, best performance and strength pleased our relational fillers the of by with and our our highlighted

now announce needs. our perioral to includes RHA Redensity, decided which of innovation RHA is lip the filler to dynamic lines. range for first pillars of a that for and the practice meets FDA-approved latest and Collection only launch broad dermal X also distinct Redensity the We consumer

the the September year, including made As our injection the the new our forward look the BLA prospect to PDUFA result acceptance and we’ve we DaxibotulinumtoxinA first date of and in pace. traction, a X progress strong the and growth our commercial of of re-submission entering half of

As BLA a review a II X-month a which a period required the reminder, re-inspection and FDA includes designated manufacturing our as our Class of has facility. resubmission

intend our As we the agency. previously did interactions regarding ongoing not to communicated, with details we provide

the that However, access regulatory satisfy a the to PDUFA that likelihood it might have received provide to could manufacturing the all investors Prior so inspection. update, the portfolio would requests agency information on date, with morning regarding our information. everyone our this we like same we have to

our their of manufacturing I FDA First, from report July the XXth that pleased completed inspection to to facility XXth. July am

and X from the previous reviewed in we closed. our considered and Next, the preapproval to corrective XXXX the July FDA actions by preventive Form have are been observations completed inspection, response related received to that the in XXX

July, the in provided Form observations. the X that reinspection agency XXX, facility included of conclusion our with the Lastly, us as manufacturing of The

about For release on would Form received July in we transparency a Form summary and reference, of XXX A couple XXXX. in of to the points we’ve our earnings XX-Q. like observations included make XXth, on press X I observations the

any our previous include outstanding inspection. were XXX of X the to related from First, it our observations Form does that pre-approval not

stated were these our that recall considered as and close. observations are You’ll resubmission focus of the previously

we provided our responses in for timely confident and the to the team which are we have proud of Second, I’m FDA already our turnaround.

eager and Xth our to just corporate our launch September Obtaining for our date flagship prepared approval priority decision of a one top expect month the We product remains and once by from approved. PDUFA continue our XXXX agency away. which is team drug to is

the has in performed a the recession recovery macroeconomic in double-digits As we sales in well American Further, aesthetic facial the includes remain according the the saw dermal XXXX, U.S. economic to sales of market such Surgeons, expand to according reopened. $X.X Even a practices top market year most high-single $X.X we and X billion against in to Society procedures. access to minimally to Historically, XXXX. which billion. to opportunity low of headwinds, approval, the neuromodulators $X.X invasive has fillers as grown filler COVID up will billion report the Resources of with and injectables neuromodulator Group our pandemic B-shaped following dermal have when and the XXXX reminder on held Plastic latest Decision the

mid to the annual billion expected X% U.S. compound term, at to the growth is XXXX. market grow $X.X by of a rate long to Over

on, activity Given on facial a and we make comments. be to beyond we an market, seen the current surrounding typical economic questions environment few potential based impact its that calling like seasonality I’d on on impact the haven’t that injectables accounts trends. would are Today,

recall You’ll to the for times fourth the the compared the usually year of and are first busiest and second that procedures quarters third quarters.

importantly, begin factors the other we versus manufacturers. impact target unique consumer to in spending take our comfort facial re-positioned of market in in downturns and resilience accounts, prior macroeconomic should injectables our the market more the However,

launch our with we RHA First, still phase are Collection. in

and the approved. strategy the go-to-market new on market, we of that is launch including we the a launch next-generation third, bringing And RHA Redensity differentiated prestige segment. innovations our focused today’s to of have Second, neuromodulator are

disorders. turn muscle me Injection for DaxibotulinumtoxinA opportunity to The for of glabellar approval us allow let Now will in lines unlock therapeutics. movement to

this category of a X programs The up both these program have duration cervical in Phase data in clinical for for completed of median efficacy DaxibotulinumtoxinA weeks. strong of our for with Injection upper to dystonia effect program X and Phase spasticity. limb demonstrated and We our XX completed pipeline

BLA We our will shortly dystonia ready of glabellar neuromodulator for FDA’s file after to in be approval cervical the supplemental long-acting lines.

expected and point entry movement be of to U.S. by into to our the about feel would million In XXXX. grow good very the in RHA quarter. and dystonia $X.X for pipeline to our our approval billion therapeutics, is cervical glabellar over expanding category reminder, With will aesthetics U.S. in DaxibotulinumtoxinA summary, the we base Dustin? business, muscle that, Dustin, that performance lines. over in the of $XXX call a Collection second who our the Injection for cover As our growth turn I’ll disorder pending

Dustin Sjuts

neuromodulator year-over-year. over million. proud totaling These half on that our you, We're and QX million delivered product of XXXX brings are XX% quarter the first launch sales of RHA us RHA that RHA results, solid This in and stands sales, very Thank $XXX million, Mark. our best own. have $XX.X increase since a $XX.X sales telling its cumulative independent

quarter, X,XXX representing Xth our satisfaction. Awareness end, During injector our the we initiatives, have productivity we of sales to over strong second At continue for driven and a Injection. and accounts portfolio by across saw training across DaxibotulinumtoxinA world-class our education adoption marketing and and be anticipating the targeted quarter practice base programs most healthy of high accounts. demand importantly, a all date for September partners and consumer PDUFA and

results continuum like rest in designed wide or natural and challenging dermal tuning Redensity our only the of excited FDA to both folds a for injection XX of the of depths to RHA can lines, superficial of for market to area lips, the for last fillers RHA and continue skin, of for resemble for refined filler with RHA launch Presenting are a of We to the and bring Teoxane new wrinkles FDA-approved for approved the severe to offer is HA dermal deficits. market, was by product dermal SA consumer Redensity. partner smoothing to RHA treat perioral of innovation RHA in first X X And and a through of rhytids appearance natural the tune deeper and Collection, RHA and found It the of also months. depth, prior RHA X, to to injection of of X the the most the Redensity RHA lip to can the formulations injectors shallow allowing facial the RHA X Redensity. we stretch adapt With dynamic dynamic softer moving introduction natural line, the lip has and range the volume injection or a have now fine softening needs. the areas line. lip. closely look folds, highly is and compared it to Redensity, fine X X across

mouth, product essential love currently also preview, In with are evaluated Consistent smooth believe is and and SA infraorbital fills a is to had ability RHA the to to potential hollows very X the prospects Injectors they another we've wait face the feedback label delicate about we're positive They Redensity Redensity a introduced also partners is of fact, to we're partner being inject our correct and the clinical in launch training positive we existing their trial anything different tear and with area encouraged of the with the and RHA RHA its and practice is education early X treat years. company products. and or for around X, our excited feedback on said than by complement Consumer Teoxane fine correction lines fillers very natural challenging only filler have troughs. line. the look X, to been the Redensity. Redensity very Redensity. of has is complete of the X to we have within It's This excited have in RHA and expansion RHA easy program shelves. by and the of market received. the

Turning to OPUL.

or QX year-over-year. was during basis, trailing in at We the over continue adoption progress capabilities end building XX-month make to Gross QX. GPV up for volume and of $XXX GPV $XXX the million membership quarter. On second a million, processing totalled driving XX.X%

an and is billion in U.S. As per a year. to important believe processing aesthetics opportunity our we of potential payment the market reminder, revenue indicator exceed GPV future $X.X

additional about glabellar really portfolio and focus for In Particularly Injection features only to the We continue with practice revenue on new how line relationships aesthetics in growth. our OPUL, but our DaxibotulinumtoxinA partners deepens of unlock approved. poised feel is not if for Revance. will for it addition summary, our growth good for with also we potential account additional

Xth Our attention date. our September on PDUFA focused is

the of be neuromodulator very U.S. market. our next practice Consistent a launch our profile to preview of DaxibotulinumtoxinA partners. program Collection, will for We much our the launch the introducing are looking aesthetic commercial forward preceded lead to differentiated to with Injection generation the by performance approach RHA with of

in for International of Injection data that new presented DaxibotulinumtoxinA we Finally, data peptide. Conference, the properties novel unique includes excipient demonstrating the recently on TOXINS participated XXXX our

Our turn excipient will DaxibotulinumtoxinA Injection, for the directly positively advancement and cell peptide to enhance aesthetics over quarter how core neurotoxin [ph]. neurotoxin -- the to data the both and formulation binding to charged combined second of and underscore can our to to poster in of commitment the new showcase the Toby therapeutic call neurotoxin our I innovative financials. of With indications. cover the research The that,

Tobin Schilke

in the product of Total of increased $XX.X second $X.X XXXX by Thank the million you, period second increased of Dustin. collaboration Collection. RHA of from Revenue the XX% revenue same and included to $XX.X for service revenue. XXXX for million, of sales $X.X primarily revenue driven quarter quarter million the revenue, million

expenses. to operating Turning

cash, execute $XX.X the continue We to corporate million second measures. our year. ongoing last operating same were the million disciplined in quarter capital allocation addition GAAP for to our preservation cash expenses on period for to compared priority $XX.X of

SG&A costs and operating and lower R&D over expenses the period last activities. were $XX.X amortization stock-based depreciation, Excluding X% decline due million, clinical non-GAAP and trial regulatory lower to year an related same expenses our to compensation,

XXXX, For the same operating down expenses non-GAAP June year. XX, ended the compared were last to months X% X period

primarily GAAP reminder, to be Injection drug to we R&D in by expense until the approved. a expense is for period which accounting driven costs XXXX to project DaxibotulinumtoxinA the costs according for standards, product manufacturing our As

expense for expense maintain operating XXXX. non-GAAP As our we GAAP our announced previously for and outlook, guidance

balance our sheet. to Turning

note notes purchase of financial XXXX. An achievement. total March cash were will for to the $XXX XX, cash in with We short-term of available believe, Pending to note as closing Athyrium additional the on and cash, earlier the $XXX uncommitted payable of the on investments that equivalents $XXX.X million XXXX. September of we issued with borrowings agreement the the Injection, committed commercial the approval option up agreement runway revenue $XXX another have million with initiate million million option target Our a enhance to is DaxibotulinumtoxinA $XXX additional of subject our issue the of million million. closing Recall approval We we XXXX $XXX of we FDA have into XXXX first note neuromodulator. Capital. in flexibility June our until the year available this

I'll Finally, million the the million were diluted Revance's shares, XXXX to of with that, as call shares of common debt. of fully July $XX.X And stock over impact convertible $XX.X excluding XX, Mark. outstanding with back approximately turn

Mark Foley

Thank you, Toby.

launching to portfolio two our of ago Our in commercial and products since innovative strategy confidence continues years services. people, and track record give our me

Importantly, up I commercial forward gives manufacturing, you open of questions. We and also for begin therapeutic half to to the tremendous the resubmission now DaxibotulinumtoxinA way. on our of thank in re-inspection team confidence launch for I'd to I'd for our successfully the of for facility. approved clinical, for preparing in the performance operations like their call also successful ability look our to the and potential recent and manufacturing along progress With it and hard the opportunities me excellent that, in Injection updating to our to first team the BLA post-approval. year. realizing will like regulatory get work the for Operator? thank their our the ahead

Operator

our Instructions] Partners. with line Seamus [Operator from Guggenheim first comes And of the question Fernandez

Seamus Fernandez

for the FDA Thanks all and the detail guys. updates, on manufacturing

So just there. quick couple questions a of

are And you that observations, closed consultants into kind minor observations I’m second spreading sure on observations. experts question, experience their a But off, and we your like a color of bit good with read clinical and bit But us is can the does what on seems us It additional talk some of just X. the closing advantage the from are your different might how physicians a see do that wanted of as great date the that X you kind with How that? to September little one to your or the as what feel additional get with observations sort about a that thoughts? obviously versus you advantage about any out. guys, color DAXI As BOTOX. the relief in clinical sort say the about was observations. you with congrats basically perspective experienced Is physicians, we trials as think those little once speak something PDUFA review will you those of give heading a just challenging quite dynamic become a on the X clinical they of actually of and product? strike first experience it on seeing

Mark Foley

Seamus. Thanks,

X with sort the by the And that ability mentioned from needed observations. So your original resubmission package agency cell our was Form great the with were re-qualify we're off, agreed first you it address where to very we the to XXX the pleased banks. the point, outstanding items to retire to observations of that quit upon work team together to

us to that continue and responses on the from we'll the to in complete, of outstanding prior that was comprehensive. our we and to public is things. go to those by redacted kind that those agency X. Form were about nothing But we heartening shareholders response together. Form feel not close just same our we received that But out There our become where on X PDUFA to these we morning certainly we the it's wouldn't September date again, that very us this the a So we we commenting related around observations It's of version for on the PDUFA feel the the important date, appropriate may latest team all of we the they because -- application good X else X given They probably observations. of comment a responses that normally information. very are X have on to got this we XXX the good said observations agency with be that were news get pulled thought to

long to question In little to on more provide terms it of commentary regarding that differently of to through on bit about your it I'd rollout does but can hand going he or second that. spread We we're a like anything color DAXI and sort so a that. over like staged Dustin, go talked

Dustin Sjuts

Yes. for Seamus question. Thanks, your

glabellar with and look those DAXI proprietary remind was very, got to and study I the received We've think of very well our that it injector the work stabilized with is ever formulation unique within the if at done is sites. first line that we peptide. by majority the DAXI was

act products. differently So a it will bit other with

that different molecule, daxibotulinumtoxinA peptide released spreading As stays actually to relative or been the Talks it’s anchoring how not of about of at with specific it attached that of reconstituted. able that, aware finding Toxins is we characteristics and just that to data relates data to to compare the It’s some once the charge the I’m positive any actually that.

that would it find that more of So to effect areas. you recipe. an for anchoring would and a little you is different Mark their think Obviously, a a as ultimately mentioned, product those bit and is the take actually of will around different this there have specific effect time practices

happy with that tweak would world in results look We’re off have things real setting, into they they the that go to trials. based Once clinical like they they really have. of

And so, facial ultimately preview canthal safety and our lines But lines, forehead with line profile upper DAXI all in we duration our opportunity and across then been lines we’ve lateral to providing very with and profile the all, both both forward glabellar with them Phase the efficacy, look X the data. program. pleased

Operator

from comes of the Cacciatore with Cowen. question next your And line Ken

Ken Cacciatore

a the toxin we if see on-site, Mark, would hopeful at more Maybe you need there whether with and just a part I out going have we bit how bit any Can roll sense, of in observations, a you about we’re to detail. talked can maybe it the you And to accounts give be DAXI of to talk answer. clinician? be process? to the wanting X,XXX bit selective currently I you a a can they give that going train contextualize wondering are approval. a out you sense actually this in give this come that, in just as rolled about the necessary label I’ll botulinum if of little the of initial what kind whether you terms to Do you as where or get there sense account through then the that follow-up Is to can volume actually you’re have? look see get out then a you’ll accounts number any throwing XX% can of if inspect? And previously different to basin us a a current about do, about be bit if of toxin? is try is to they botulinum situation us for Can any of us these for talk to discussions? kind I’m volume of their know Just a rollout, volume you in is engaged random and terms of these

Mark Foley

Thanks, Ken.

felt FDA we able us we able to response provide comprehensive very feel how to identifying. We I of the the the exactly recent to we're that that and So were what in do your to to There regards that comprehensive in mean responses. to put provided no comment summarized in to not reinspection? terms observations in the first with data for receive responses the Form for waiting we on -- But additional X we we on. expect the question, XXX is a expect observations. were responses the appropriate will good

date that close X, this the back of X that able good the September And from feel continue earlier, to again, comment XXX. is original really observations out to a were day so and the we to Form we good PDUFA we believe kind going

we were we FDA inspection no in we included. there. communicated again point. our already is else CRL last already thing that outstanding the had that of facility The that there of been believe at label We everything itself, updates the sort -- and negotiations when On was time that received the up the at wrapped point only time, label new with so

And so that. there to is no update

roughly the often you sort top So a the of hand of I'll but of accounts second know regards the of characterize we're to we sort in targeting to XX,XXX strategy. the last of over one third which this part Dustin in rollout is as market our DAXI, prestige

those. still those in call this to accounts in really XX,XXX were XX,XXX of a accounts. X,XXX They subset of So

go. position the those on toxin a in I so, still have the X,XXX that in But of to don’t And comment occupy. of we able sort that in to greater of him speak know market terms rollout accounts detail. we’re percent to ways I’ll be let strategy the to

Dustin Sjuts

thank you, Yes. And Mark.

as to our we've preview we're relates products program. proven going record with to out track So for rolling follow had it DAXI, the

of a Although rollout this providers our headquarters. focused areas. X significant to will program were our bring on to really We some Nashville training able

First, clinical.

perspective safety to trial DAXI need we know duration and and clinical clinical both X of X. our across you the an of Phase As go all Phase through perspective, profile from efficacy

is important of integration. and it's practices not practice how to inject also them. but consumers through actually formulated ever profile, We'll talk understand, amount how peptide We only how to go to product duration the see to practice, first will right Mentioned to markets. products the in formulation. about that product convince We with this charge then the into for similar integrate often in and lastly it's that. how our earlier, the for with efficacy API delivers and the And the other product

felt like broader category aesthetic roughly the RHA, XX% of partners. your into marketplace. exactly key of that have like get The how comment well in as minor RHA, So fleets focus around with that without real as folks We around the of on DAXI our will practice also period learnings they the injectors that then, final through all setting. represents recipe time that to OPUL. will for of And prestige on in just then utilize kind world question. the leaned those a a go make And we'll

foundation the for And a to for that foundation for accounts start so good we the feel that great be we're Injection. DaxibotulinumtoxinA very will in

Operator

Stifel. from comes with Samimy And line of Annabel your question next the

Annabel Samimy

on is the have already already Can it are the out who those rollout. different accounts accounts rollout like KOLs but you used to reaching who very filler very, follow-up RHA that using that that with full plan, clinical adopted filler overlap confirm are just were not RHA DAXI. or a you close, had you or Just may

we’ve strong that. So because not as still done would And the penetration. But in second just to question still they this there I’m if population differentiated strong market niche, a products surveys have as reception all view long-acting -- and it know, and the curious typical. some reception, regarding have I about the you are be in is, drill very they viewed the are down you that would broad may little as further, use they broadly clearly

market you unless in we’re So -- down detailed you receiving are surveys do? we with receive penetration of probably and research is your our today? when your Thanks. what drill finding forecasting expect what that in broadly they Do do you

Mark Foley

take I'll first appropriate. add on those, can he feels then Mark if

of how previously. do primary happened physician-by-physician, hands-on to also injector-by-injector. from that those and rollout, go to that perspective specific outcomes the to other It’s leaned Who help a those from learn combination today’s integration, in important with not our we but us will launches I'm podium this are this be maximize journey going is on learn that and those work look us also on be on But a in that that first of through and a us have process from in to willing at to from on position practice So focus those also great and focus are environment, getting are those going providers no, how groups. both each perspective with a outcomes.

So it’ll groups. be a combination of those

consumer the year, be the a offers well to of value will of to and practice we is It’s different received. uptake a others it uptake relates it efficacy toxin market research, the that patients formally that unique first good something from very This our kind that profile, perspective. they’re of duration clinical and or same. if proposition With believe product. product an feel are As will whether this perspective more with value will we other the All botulinum Xx with and this more got for have both Injection a It peptide to similar times receive they looked they different getting get twice than anything that toxin DaxibotulinumtoxinA is had they injected to at toxin likely, our year a them with DAXI, a X.Xx going toxins. that aesthetic have year. be a getting most

And a of that can add really it feel good segments. so value we across variety

Dustin Sjuts

I'll still that, just And Yes. to add Annabel.

So don't practices and market. it a gives its alternative have we we a it is niche certainly a the see and this having place about as about talked will thing long nice long-acting Certainly, choice. consumers

doesn't a fits the it so practice. And for need and alternative both be believe we'll to provide, valuable we one size all but patients

is which lack over Our products. that that express And done of duration consumers the millions got and at times year. both reported you've that out categories a market of XX% the in that, existing despite with both they of the procedures identifying are is injectors research those suggests unmet of of disappointment being the duration to these kind amazing toxins number being one need and that's continue

a nice add really of armamentarium is patients large that a and to will consumers the be will an and and alternative to it portion we don't the alternative. of expect providers injectors this look practices it's that resonate and to be we believe everything we be and going so, the this to to an do for expect everybody And but that

Operator

your of Sandler. Amsellem line question from Piper comes from And David next the

David Amsellem

questions. of couple just So

had were happen. sort where maybe XXX, you of you this flat-footed an there a the were angle different to and I'll Is take Mark, observation. that if caught back I going guess Just or ask something surprised is you you, Form something at inkling additional might getting

Just RHA. any And there? insights secondly, to gain see can wanted if then we on

you not forward talked anything going seasonality. about product grows is consumer this there you in macroeconomic seeing year I that I think extent as get the behavior the trouble a phase that is on -- and to been the out, you guess XQ spot, You look talking your how the still, about. if is the I season beyond as potentially backdrop the given we’ve which of question at footprint to Do play you’re strongest might of these mean, will? thoughts part pressures. the

Mark Foley

David. thanks, Yes,

question, or surprised hoping disappointed? an observations, all were clearly, prepare that first have So you we you're when I right. mean inspection, any for can you

did I'll closed come to the but XXX. Form an the fact and observations back team amazing they're first to but the say X we from job the going that So out

think So did team job great the a I there.

and kind we the a was that comprehensive where single follow is see batch talking nothing X outstanding. or We there case. the of X we else you’re Items get hence provided you’ll batches, very summary a that’s to about SOP, that a where responses, in development provided from As procedure related single

And everybody love to sometimes liking any but inspection. observations we to so home had it not would certainly

You you’re sort again, team was job. get very the the ready But back the again, our a put and of that forward. I’ll And think of prepared come kind proud with to and I and and response the findings. of did pleased great comprehensiveness timeliness

things think behavior, noting. of terms there’s a consumer that worth are I few In

out coming more conventional into discretionary and of facial the resilient this things going on make market a they’re through any to little bit these until so QX certainly, fairly that segment off into that pandemic less proven closer are of be but are we is these become the QX, as XXXX-XXXX for First wait lifestyle side to economic commentary more of has and to we’ll patients. you’re you aware, know, downturns integrated have other to to the sort start a that procedures, injectables

prestige of over periods new so, calling practices on to you we’re we re-density, But or impact not more accounts bring with go still that items. if of plan out it’s look subset launch sort innovation even And muted X,XXX RHA but to lumping far, we’re this category. before, of a and a smaller a seen side, kind discretionary us another an just And early back conditions than today, and our certainly did least it time in maybe spending softening that’s launched time in the was of it are thus at having if and give into we’re neuromodulator, also other that approved base on kind going we for the of pointed where macroeconomic we’re as you yet have market. into at did just

to going going some we’re conditions they And should in and forward. be things pronounced so, QX have counterbalance macroeconomic that to more any

Operator

next your Lugo comes with from Blair. Tim the And William of line question

Tim Lugo

kind again within this and just you doesn’t how much can?` redundant are difficult regarding X the of you and repeating is issues talking cell Can as observation. be in working the can I And having working redundant working form guess the cell degree press us what it that third this a working with mentioned for of may about observation the I the sites, cell the add bank and last be bank, bank mentioned to seem storage just think lack cell now sites having if bank, when not it through guess, of, to the that release I clarify new the fact you the a a this remind as adding I’m

Mark Foley

Tim. Sure,

store sort signed that is is disaster maintain of facilities material use our some of more registered purposes. bank a to we kind This us with third-party already of we cell third-party So, that for used. redundant already and

And newly X filing, to had working issue in the was qualified cell we the banks. not BLA that that for include so, updated site our number

addition us. of redundant to working did So, under cell new address of facility the registration storage we bank in already took filing care is that the we which that, third-party our with

Tim Lugo

bank none is this it working validated the comes from the Form again of been lack when mitigated of That perspective, kind able last we and jump all that on was Okay. issues from those of I to enough. XX,XXX-foot are of to was have easy think but sounds does ahead a know, XXX? that easy manufacturing cell the -- [ph] raised guess I kind

Mark Foley

Yes, to we in that’s what remarks. sort tried of our communicate prepared

provide with product qualified FDA time batches needed app. ultimately they clear information the BLA with the of a showed substance lack was to meeting, at cell and of the the new of necessary observations in So, up qualification the them us the our of in our with order the X in one and bank drug see to consecutive for from and drug resubmit what was the us part of FDA they terms wanted after one indicated X that Type time the what bank last A cell we

indicated our have original So, that facility, X recent of they resubmission XXX. provided all the at the we the information in we and addressed in that inspection observations successfully our Form

those closed that of bank the qualification or provided of questions cell end. very nothing good cell the been The right now have outstanding. So as mentioned, bank. any from nothing we us recently as again that we we the responses we’re have summary Form that all and are feel are I remains open to after. our There is relates the XXX the is it only X things to those with And that piece the of provided provided

Operator

from Douglas from comes question H.C. Tsao next Wainwright. of line the Your

Douglas Tsao

Thanks the good Hi, for questions. afternoon. taking

Just just to point. one going want XXX, the I clarify this to back

this So, boarded. but lot it sounds lot related to a these sounds were like observations both it was single like

satisfy with Letter? original not to lot was lot used requirements or So, -- the Complete to the this this clarify Response confirm of

Mark Foley

That's correct, Doug.

was two individual be there. The one development that lots. summarized, on So, of are awarded these based league the sort

separate The for independent process. of clinical were with for then loss. a any other block used These of our neither sort one sort development validation development trials

Douglas Tsao

Okay, great.

evaluation implications in or don’t the any don’t, they besides don’t process they affect to addressing of FDA’s of way meet I have they of are issues -- so implicate know just confirm And the again but BLA sort just the for BLA? which the these broader BLA important

Mark Foley

on speak working to in our But lots I related that FDA drug our of validation want go that to batches that side. lots were mean, were cell yes, I sort or were so I Yes. not far behalf were mean included new substance, substance development of drug of bank. observations launched. one-off to as on single the these These don't

Douglas Tsao

performance enough again, maybe just the back, RHA great. Okay, sensitivity. congrats stepping just -- FDA to I far then wasn't I to want that understand of And speak on for the And line. the and

nearly good quarter. the in second in your performance have didn't filler the You key as know, competitor market

think I down up meaningfully were a You XX% sequentially year-on-year basis. and they of sort were on

saw in sort you your that have environment an saw anything, So has I'm the broader been curious some if of is you know the given there might just if of saw? just the sort I curious economic environment. about competitor what concerns anything there spoken largest I market. was to anything macro just

Mark Foley

their try it say are finding the in willing really add. is head launch filler evaluate then focus outcomes. then we're know, drive to if of sort that and seeing accounts You great that of beginning and collection. we're over approach sharing RHA a are to to to trying think Collection Dustin hand is I'd I obviously fit methodical the sort to education, nice additional And line in I'll accounts really and RHA color doing that it deeper and taken, that that mean kind influencers he with phase to and of through are those experiences and training got penetration we're we've peer uptake. any again

there. I So reflection think have as way to the what We've a something make and you're accounts, very us. natural focused this And of that right adding pricing, they're product transparent help taken. due I that for line moves a where it also a profitable we're the value-added to strategy sort of service strategy to that we've trying think seeing the sure got incremental product is taken it's that's they that a we've getting and outcomes that prestige on the deliberate

bit to steady penetration. if to we add you growth And Dustin, of But so, we sort to issue goes, account drive in that? just continuing don’t anything did want in the I more deeper a quarter, know little

Dustin Sjuts

point the So that and time. it's hit not I built not at in certain around you built differentiated strategy a think around fact couponing programs

and business that heard value product the being to this certain formulated, that. from uniquely injector continue adding and both you had program they drive the the time certain our behaviors we leverage organization And to on think going how I to we're to around commentary uniquely in consumer. have built

we've that so, got mentioned, front nice expand us opportunity got into SKUs as accounts we've base. allows with And us to of in also a different opportunity to but Mark deeper X account our go an

in different about feel very those to leverage in and employees that So we're we position good unique some and competitors a that. of continue

SKUs And to got mentioned, X to so, with that got us go we've in different we've of deeper also opportunity us front nice base. as allows Mark a our account accounts. into opportunity expand an But

competitors we're a So about that good to position some launch the feel in poised we very of unique and different and and in those portfolio.

Douglas Tsao

the on and Okay, much congratulations great. Thanks progress. very

Operator

And of question your comes from from Belanger line last the Serge Company. & Needham

Serge Belanger

of close observations, on in actions FDA topic is get the responses, feedback I’ll -- XXX terms out of you any Now you’ve in your rectify guess suggestive to they are from Form or submitted issues additional these the the that your observations? kind if I afternoon. expecting Good new provide

Mark Foley

responses we back back. this possible the agency it's anything could PDUFA than certainly and our other we've back. heard date. the It's not hear We that we decision their something At on anything final point, quite comprehensive provided of won't hear to likely sort

Serge Belanger

some be or hear it you something would the disclose on you the nature back that if And depends response? of would

Mark Foley

bias there imagine could our that and that mean, think normal Unfortunately, takes a at variety never I not is you is that's say awareness redacted XXX flavors protocol. interaction would Yes. our likely again, a few I we agency towards the providing the that had of out there with ongoing our this were date. there put PDUFA times morning to to Form that another break prior out put in our XXX from to get due

thought unless that. was something So significantly approvability, we not be would it on compromise our that commenting we

Serge Belanger

just rates. Based X single-digit earnings double-digit is its Okay, usual fair outpaced significantly quarters enough. other or And this X toxin of then high broader that, last on in companies, reports market low a question. least growth at to a market the is the

following that changes your strategies Just in for pricing how DAXI? curious

Dustin Sjuts

is this Dustin. Yes. Serge,

I all side, opportunities XX especially here more the years. first think, right. first one for more has growth, that The players innovation in the

that's on comes when really feel that a capitalization innovation market, opportunity. premium. at in any especially good so growing, our about And we And

that And pricing about both feel good to something. We injector so strategy. consumers. opportunity is the we have our in This premium value provides and the the both feel that about launching innovation we good

grow continues to changes So, that and the we've today anything market our seen on kind just forward merrier, to we we're strategy the happy that. look think capitalize I don't the launch really more of

Serge Belanger

dystonia. one. But the One what spasticity other know re-initiate it. to development But migraine one, submit last you about Got for talked about the limb plans past, your about indication? to of indications, sBLA on upper talked the is cervical obvious therapeutic also you you’ve plans

Mark Foley

through muscle on I particularly, our to filing encouraged Yes. of sort want we're approval first revisit into sBLA is allocation the based be for the that. And our and more get market disorder we sizable want therapeutic. represent cervical where foray will we clearly, and about then into which movement But dystonia to the and dollars. capital our sort our think, focus that and Serge, of category

cervical So, feel grow that that these are advance over to long-acting neuromodulator to so the continue dystonia. we clarity get I we’ve resonate more you. is program category time and expand about We what’s and promise think around the the believe the beyond we’ll that markets to and a this of will back right got still time therapeutic in

Operator

you participation. Thank our ends Q&A This today's call. session and conference your for

at Goodbye. disconnect You time. may this

Revance Therapeutics (RVNC) 10 Aug 222022 Q2 Earnings call transcript