ACRS - Earnings call transcript Q2 2018 | Aclaris Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen and welcome to the Q2 2018 Aclaris Therapeutics, Incorporated Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions].

As a reminder, this conference call maybe recorded. to Legal host Officer. like Kamil today's now Chief Ali-Jackson, would introduce for your conference, I

You begin. may

Kamil Ali-Jackson

Thank you, Aclaris Krystal. results. Officer release for I second am Kamil Please announcing that Ali-Jackson, note earlier XXXX today, quarter issued press Aclaris. its financial Chief Legal

those website not it at will who www.aclaristx.com. yet, the Investors have posted the release in you section of you For seen find of our

and President Development for Financial Joining Chief Dr. Ruffo, our today and Walker, Chief Gordon, David call Neal Powala, Frank Executive Officer; Chief the Commercial our me Chief Officer; Shanler, Medical Dr. Regulatory Officer; Stuart Officer; our Chief Officer. Chris Officer; are; and our Brett Scientific Fair, Chief our

statements we during about begin of results operations operations company's the Federal objectives call our of within make future Laws. remarks, forward-looking the future Aclaris' meaning we and financial are and like plans prepared considered strategy various statements position, to for business and would this Before that I remind Securities you the

is section available and today; the These documents ended XX, later time. XXXX, March Aclaris for Our actual in forward-looking assumptions Management's Results the filed could Form quarter All risks the the such we make described I'll on expectations These that that our call from Factors year-ended Dr. website filings we of the President in webcast. link and that SEC SEC XX-K Risk Operations of Aclaris' of call no otherwise. Aclaris' may Form of the new materially be to the on uncertainties A are and obligation account in and cause current conference today, is or risks, to update provided turn information, makes as statements. changes future Discussion involve being Aclaris' on section to those Investors under Please this to of to for December reflected and statements circumstances, differ undertake of are website. from this recorded the in forward-looking Conditions we of the at based now are Information is advised of XX, and Analysis Walker, call today's Financial time CEO information section Aclaris. to any the Neal? XX-Q Financial events of XXXX; other posted with Investors Neal results statements over provide webcast and page upon with www.aclaristx.com. and the call be

Neal Walker

update our Good address then will Thank off our of you I other Commercial Chief and everyone. Kamil. launch. business ESKATA programs clinical Fair, start highlights development morning to who brief a and Officer with will it our Brett hand

our or Shanler, CFO our Chief results. review development will and Ruffo plans Officer financial clinical Stuart Scientific will Frank our which after Next timelines review

Following the our who up we portion will Officer your take Medical to Chief Gordon questions. also line prepared recently will available Q&A us during remarks David be the the call. of new Dr. open our joined

to the meeting XXXX both of XX% we physicians May During ESKATA quarter after solution our second patients. of launched at topical sales the and national beginning

During primary of our XXXX. the in in the option goal initiate as second which of the account field campaigns weeks bulk consumer we our launch half back up the progress the made first quarter of significant accomplishing force made driving eight our of

in of known vulgaris common warts of the treatment this half the the Phase Phase and made regarding pivotal good of end we In progress the In we A-XXX start pipeline completed addition as advancing quarter. otherwise exciting meeting for year. solution as track with an on expected to program second during in July launch are topical verruca XX% to X second our the also we've X FDA the

oral our in inhibitor a dosed Areata Universalis. of trial JAK JAK inhibitor and with which Totalis we includes patients our patient phenotypes more first our the Alopecia X in severe program ATI-XXX Regarding of Phase Alopecia clinical

we publication for clinic. stage continued the of indications early on therapeutic are accepted remain these MK-X in variety inhibitors. inhibitors, Recently and immunology of next development in Journal of the was our about ITK and to excited our the asset this to generation Research Turning preclinical towards assets Cancer our areas. inhibitor, our a advance advancing JAK and manuscript portfolio and pipeline, rapidly portfolio of Pathway ATI-XXX the selective of we Inhibitor We of MK-X potential

morning label In inhibitor an topical open announced update JAK addition on the we this studies. ATI-XXX

interim label one Universalis. Australia for As These enrolled has the intent that is XX to proof at which study the topical portion validate study study of Alopecia currently extension Alopecia along Columbia in a am goal and June open withdrew patients concentration the led the a the prior to this which target us study the provide interim in topical and initially pleased label an we University studies as and growth today way. PKPD systemic in during much the which I open the Alopecia with two Totalis extension. primary early hairy which into report of anticipated X Alopecia the skin, rolled one the approach data of drug reminder month we looking both engagement of enrolled in are then treating open X are lack extension Columbia than from remaining site of open have slower treatment study. exposure. X helps Universalis was the patients reported designed label at with and of demonstrated a of progressed label and original XX University evidence the to PKPD Totalis regarding which updates at was of principle results positive the studies open label conducting action, ongoing. In to The we The patients in portion extension. and seeing Areata Areata of six to

study withdrew specifically Australia topical In in was X looking label patients than the with of which period. was that slower we patients the the six early also completed The XX in signs and patients study. and Across yet Alopecia affecting studies at month the enrolled the unrelated open on in study no ATI-XXX two also for validate efficacy seen patients range to demonstrated in of by label hairy study XX conducted growth have University reasons this to drug. Alopecia open X the drug patient has patients early eyebrows. The has full the Areata Columbia designed weeks study been treatment from to second and approach

explore data on generally refractory trials treatment full to As allow no and thus tolerated extension expected in well reported the adverse we serious the both plan term results those far AT/AU an patients with encouraging related us obtain each with response safety longer has and events extend been will today. ATI-XXX patient Based datas. study to more

studies, the a dataset who addition providing forward Brett commercial in provide studies our two consider oral our induction of larger on future In the range studies us allowing topical both dose AU/AT will strategy. these Fair, These and turn into months. providing will over updates now XXX Brett. coming activities. in additional and Commercial our on patients to extension to a opportunity study. as response with Officer the Chief to We an roll it AA-XXX will I'll provide look update to unique be we an extension maintenance treatment

Brett Fair

good and Neal you morning everyone. Thank

been accounts force Aclaris ESKATA in Following We're with the of in the opening over launch the meeting in launch. sales May established have has very accounts. early XXX pleased successful base we the

application a and great technique We've keys learned to driving to integration within clinical continue deal it focus on early accounts. the these will successful We to as experience proper integration. initiative relates from understanding

continues experience we're from delegated their learnings they impressed staff Our the seeing excellent sales build practice. support, ESKATA and on to option outcomes HCPs Feedback And and and is with effectiveness patient ESKATA raised an implement administer in that with training to provides early easy patients sessions and ESKATA force SK. for to treatment treatment. services these product. on within for the pleased initiatives train favorable the live early patient one of and and We're the

determine patients from early to delegating of ESKATA that keys would over methods. indicated said regard their ESKATA socially. were XX% will of out easy. another the said in recommend of said neck. of from we as go more had office, of our clinical to face application they've would Experience to HCP treatment over the experience ESKATA time. XX% once forward moving they treated additional integration. patients and these enough Over were are day for results comfortable applying of an Initiative center important survey delegation on treatment XX% physicians business reinforce integration, or raised application effective hands to SKs if appearance and identification prior they are results easy XX% would ESKATA With indicated looked recommend clinical driving the they was patients comfortable we after in and encouraging establish proper The in Over as to of updated XX% previously patient very experience to treatment Here extremely completed friends initiative. trained that of Over with that and lesion Early accounts. that on treatment The ESKATA they indicated success that positioning and products. patients the reasonable ESKATA was with amount that easy the XX% the a is be XX% physicians in

important Additionally business also professional patient the attended organizing technique with to expectation dermatology accounts. optimal and that and peer force recent in connecting in programs well the were efforts to at generating aimed high and There sales meetings beekeeping and nuances look team treatment at to role peer at demonstrations continues relations In space. to initiatives to live and DTC drive related With is Bootcamp Meeting application conducted was as a respect we most the demonstration Live at well speaker productivity the proper interest outcomes. an on our focus NP+PA patient integration will as major product implementing very the given Derm product most important conferences patient SCALE we are product data our supporting as in Cosmetic DTP the play setting at response webinars. look Maui the patient to drive to parallel as theater recent this ESKATA. ESKATA

more build the ESKATA The and TV many office have filmed speaker treatment with we've conducted air these the respect assets productivity that continue long ESKATA commercial bring planned communicating to plan our we part addition initiatives driving In peer-to-peer regards it go Collectively SK DTC our comprehensive the includes throughout commercial in of conference year. drive to and HCP goal library and DTP with can with ESKATA. connect to to beginning platforms interest peer-to-peer driving in ESKATA and to With will we October. way in the in XX to materials value help the practices. to and both over media and campaign patient that TV awareness ESKATA in With programs a activity consumer the office. the commercial is a digital of print our of the

to look our Stu. over I'd foundation the our campaign and the this overall our will and/or the that Our Stu Dr. of summary turn in provider a are dermatologist consumer to to find see the DTC eskata.com we go in effectiveness accounts and into ESKATA to them. call solid like of Shanler. fall. integrating In We to CSO encourage adoption pleased a advance to with With product. patients laying near their account efforts

Stuart D. Shanler

Brett Thank good morning everyone. and

track Firstly, regarding the of as and July in with Phase the second clinical A-XXX Neal the development or of trials XXXX. common FDA mentioned the we topical completed X XX% vulgaris, warts X we our to verruca of end in for Phase meeting on treatment an solution half begin are clinical of

forms to Janus dosage program program, and of to inherent developing address in the our our many inhibitor we other Turning in order dermatologic a oral JAK Kinase reminder conditions. of disease in spectrum inhibitors both are inhibitor Alopecia Areata phenotypic JAK or as topical as

of including treatment the severe the FDA granted is X/X and Universalis. FDA's disease variance fast designation more investigation quarter review medicines more Alopecia Alopecia JAK U.S. Fast for with development of new And therapies [ph] Areata our medical receive serious eligible we topical an address maybe and Areata investigational Alopecia designation FDA a with designation the Alopecia the potential therapeutic inhibitor that The with the conditions drug ATI-XXX announced and communications facilitate need. of to to unmet expedited Totalis intended for may of and an receiving the frequent companies for new Track fast application. track This track to of

dose randomized parallel trial trial X in data conducted two group topical the hair trial trials our on a in trial the ranging topical the Areata. double in XXX is with response and Regarding first of This and patients will of our the dose AA. is This trial efficacy States of AA-XXX concentrations of XXXX. clinical up ongoing a evaluate in-vivo treatment of topical Phase ATI-XXX regrowth for of blinded controlled ATI-XXX United the are being expected to in is Alopecia half

Our VITI-XXX treatment ATI-XXX trial of XXXX. half X data are of to of of is for in This the expected VITI-XXX vitiligo, the XX topical the open-label up in this ATI-XXX vitiligo that facial study VITI ongoing clinical skin with topical on trial, is the facial first trial will and evaluate patients efficacy Phase for repigmentation in of vitiligo. an

or of ATI-XXX the female known alopecia AGA, ATI-XXX Our hair pattern trial AGA-XXX up trial trial This first of expected treatment XX or are male is AGA androgenetic in Phase regrowth to loss. topical efficacy also trial ongoing in the open-label XXXX. the as hair clinical ongoing of patients of will and topical the in for an X of with on data half evaluate this

dosed and to applied This in ATI-XXX trial patient with AD-XXX safety, United to twice AD. affected conducted mid-XXXX. first was daily is in for trial trial being will this atopic Additionally the expected ATI-XXX in from announced patients moderate-to-severe in and clinical are a atopic trial of four we weeks of the with evaluate in which the X that XX trial, efficacy subjects or adult skin up dermatitis. data label Phase States we today dermatitis open This tolerability have Topical

JAK ATI-XXX Turning oral with in vehicle-controlled is hair X of AA. will treatment on and Phase for evaluate is of ongoing Oral patients and to up inhibitor regrowth to are inhibitor double group of ranging trial expected our conducted JAK AA. of parallel in States this half data oral second two And the concentrations randomized study AUAT-XXX This XXXX. of the ATI-XXX, in program, is a dose an of United efficacy of XX trial being the the the blinded

our to XXXX. an Regarding oral on that of track a And estate, composition. our is stage inhibitor investigational or noted new drug U.S. May seborrheic finally the IP hydrogen patent keratosis earlier treating peroxide as ATI-XXX number XXX patent mid the assets covering Neal XXXXXXX file remain application immunology ESKATA XXX earlier regarding we our using or on XXth MK-X issued stabilized methods was in

With such provide XXXX marketed Frank product high I pending term hydrogen current Book. that includes who for stabilized also U.S. in patents patent this Orange quarter. ESKATA and state our of Orange our concentration in Book to ESKATA from international results the claims XXX listed is two includes to the are and state, well peroxide. U.S. as our Orange adjustments. for This now set hydrogen Our which is Ruffo, to to patented the such extension formulations. turn any of to methods patent patent April listed over patent CFO the for of augments listed XX or formulations overview in particular XX This call financial using ESKATA the directed subject applicators applications will an like and other Book numerous as peroxide and Frank. would expire

Frank Ruffo

Thanks Stu, good everyone. morning

today's results tables through financial XXXX As press that can financial be in second our I walk please found reference the quarter release.

$X million research XXXX dollars officially ended ESKATA of May of of For launched revenues other million, the million, June which In quarter X.X net and X.X ESKATA. total sales were we million. XX, net revenues of $X.X consisted revenues contract

specialty to wholesaler. for ESKATA As title a is revenue reminder transferred our when we recognize

our recent about was gross realization XX%. the For most to net quarter

of includes fees into offices. currently deliver cost to ESKATA the administrative gross Our discount distribution necessary and HCPs net

Cipher of SK on well was includes receive treatment ESKATA. on as commercialize and Our milestones achievement additional upon gross we Canada. agreement upfront sold realized of payment A-XXX of the $X million rights for XXXX the and solution the royalties an royalty to a of and Canada during XX% April commercial we sales as the license pharmaceuticals. regulatory sales profit in topical on X% Under made to of specified received quarter Cost ESKATA the of XX%. sales they milestone A-XXX payments in In of goods recognized terms net the licensed

or XXXX million months were revenues revenues June of respectively. contract no in million. X.X revenues the research six months of of For period X.X cost either and and were million ended were for XX, revenues XXXX. six included XX, X.X revenues million net total June ended which Cost the X.X There in XXXX quarter

for a expenses of $X.X XXXX million During the half included of half compensation to based first million $XX.X compared of million million increased XXXX $XX.X the total respectively. operating and stock first non-cash to our $XX.X which

and for During total expenses same million included million and expenses due R&D $XX million in was million our increase based XXXX a $X of respectively. million year. the compensation XX.X XXXX increased our X.X to to of $X.X quarter increased second result sales stock programs, compensation expenses to our ESKATA quarter QX the stock in to development services operating launch due XXXX May personnel quarter JAK of in million other XXXX a compared the completed to first A for prior our increase was compared which mainly of to in million were expenses XX.X This million the expenses. X.X the legal, related XXXX in $XXX,XXX including in in non-cash million increase inhibitor increase this These of XXXX. in hiring $X.X increased decrease and General personnel in affairs and offset a million million ESKATA. XXXX related as QX to for headcount and professional million and increase launch and $X.X and due million $X.X expenses $X.X of a drug we expenses training, was and increase sales personnel in increase and meeting, a headcount stock for including of QX development to by the in mainly expenses million a team our programs, $X.X $X.X marketing ESKATA. including based million million realized which to in of QX direct stock $XX.X XXXX $X commercial including million our This QX to marketing increased the national professional, for result related to a employee a facility support $X based quarter-on-quarter in launch and increased expenses increase result comp that our Selling medical sample XXXX increases fulfillment related marketing discovery force million included compensation. expenses increase field the $XX.X the change related administrative XXXX. were compared of to non-cash increased and $X.X increase

quarter expenses G&A Our XXXX was NDA payment in the as quarter the of to second included milestone milestone million incurred million $X.X payment XXXX ESKATA ESKATA. launch second upon a that compared in $X acceptance of the made

for XX.X loss quarter $X.XX the second compared or per XX.X million Our to of for net $X.XX and second was million quarter per of basic or share XXXX. diluted share and the basic diluted XXXX

XX.X first was per XXXX XX.X for compared the $X.XX million million $X.XX diluted to loss half the share share of and net XXXX. for Our per basic first and diluted basic half of or or

XXXX provided our for from burn in cash incurred cash capital. million first half $XX.X operating XX.X working million Our changes in in non-cash $X.X was million we and charges the as of

intend until and product in anticipate XXXX on our transactions We capital we had business this the activities. trends our be March As quarterly to annual of fund half from to earnings regards giving we development our million. not $XXX for or outlook of any will this underlying the or With and cash provide key year without sufficient effect reiterate guidance trajectory approximately operations investments expense financing our XX, into to financial to have product ESKATA clarity the revenue We new second potential June XXXX of we guidance do XXXX greater of year. call full sales revenue.

range combine expect and reminder in X compensation $XX we SG&A our in to million. XXXX the million estimated a XX GAAP to items of stock and be our As including based marketing of million to including R&D of range XXXX XX sales million comp million expenses expect G&A of be to the and which expenses $XX GAAP line stock-based million $XX

of XXXX As stock common of XX roughly shares outstanding. had June XX, we million

Assuming and shares to no expect outstanding over XXXX call that would back million closing be for equity to full material I'll shares about average Neal a turn we issuances our of XX.X with few year the weighted remarks.

Neal Walker

dedication, been a broad launched immunology molecule has most to with into of of commercial as hard our XXXX patients for I the Thank progress start pipeline therapeutics, on you stage have focused on staged commercial for forward a and dermatology We commitment suffering small readouts multiple first you raised you company can year. We launch our look It throughout ESKATA with to please now biopharmaceutical extremely a robust am an product updating and poll discovery dermatology. portfolio our questions. engine. SKs. a evolved and and importantly to Frank. proud exciting work, deep team's clinical pipeline, clinical we Krystal,

Operator

our question Cantor. from Instructions]. And Louise first Chen from [Operator comes

is line Your open.

Louise Chen

thanks JAK for questions my on a questions had the program. data. and congratulations eyebrow the I few here positive on taking Hi,

So of the open and first open the portion label in trial? many responded I how the label Columbia was, patients eyebrow question had both

Stuart D. Shanler

Louise. thanks Sure,

part -- was that characterized due -- first, XX by that severe so look look extended AU so slow we study. it treat. hardest study when And at enrolment eyebrow So in we the Columbia let's was to in at of Study the the patients some large phenotype, the most to the all predominately

that nine already, was showing out four have patients responders. have a and through the degrees out you of actually so the of population actually varying four response look three had are have and aggregate about six we of rates if -- out we it gone first much far So months in the nice we harder who of

extensive and with disease. excited So given we're in patients that about more the really difficulty those treating

new that and patients going what the hair has out On And growth. of growth label we portion have the study, eyebrow now open in balanced we terminal patients AU have we're hair seeing slowly nine enrolling nine in Alopecia the that the also that and six patients. through -- study We patients -- patients we're Areata Alopecia study again started seeing much quicker. that patients study included encompassing surprisingly responding opening we is Areata was are AT/AU up and the to not because with just

really both So feel good whole that encouraged to a the and studies intent think of read moving these topical of viable And -- we we're might forward. we've that. like patchy was to demonstrate through really study I a what approach I it's was hit expect in our

Louise Chen

Okay, the why thank in you on patients you. color My eyebrow second question two withdrew the trial, withdrew? provide can that is on more they

Stuart D. Shanler

so across studies that four Sure, there these withdrew. there was patients both was of

doing a little why them blood reasons a that early way start highlights least study was times the somewhat There the it's patients all biopsies. than just we signature on When withdrew from with out patients asking for in that biopsies to the bit due to to depression looking to additional withdrew one hang the that data two study tough to patient and gene the enroll. By draws and also that you're that drug slower Let's was there, one study unrelated due Columbia. were of couple anticipated. was didn't at they then day and second for want fact these

was study, reason And easy is eyebrow quick and in Columbia the when other things follow like time with this we but would where the of enrolment of two be on then layer one very of condition withdrawals are the consent. leaders treatment was a a in you just those site that it they challenge. You one the withdrew some fact the had lost to and would there up think it

related to group. all four to study So unrelated anything reasons the

Louise Chen

on just seen talked drug? earlier JAK in about program, and patchy as little then your to it a comments AU, have bit between I AA, any and relates the more there you know you are differences Okay, AT, the

Neal Walker

that's actually a not and surprise. are there Yeah,

little and both I the address think robustly we've you quicker these phenotypic in that patchy the topical AU/AT we that, Areata need we've pretty and the clearly to much patients from spectrum than who And a particularly studies Alopecia more are just the total that -- feel only treatment. need longer market oral. beginning seen AU/AT. And you been consistent like respond bit

study four that has us the treatment makes sense because hard from that induction let's GSK. three it about in nicely six this is we've that months treatment, you actually and now it Gordon started David And are expect an to treatment, or offering four to to literature, part months joined all patients opportunity are and if you're through something these then going of we an we've actually six things more seen the like be So continue things topical like where tracking can to putting AU/AT and you call our reason roll of in start to may thinking maintenance really months think for about patchy as might extension see to in studies the the it patient our a into patient. to all

Louise Chen

you're we do lot, but progression, how color the you move else, the of about that on think qualitatively for force, we question the and thank giving into just about numbers maybe as Okay, the guidance one should in ESKATA just sales and light I second thank you the not year know any the your half you? squeeze of new product or think DTC, I I ramp last a then anything can maybe sales in curious get how

Neal Walker

over Brett. let comment just I me then on to that it will throw say Yeah, one

and number weeks, three they But the they then in, if in involves one in this you're treatment. response a that treated, lesions. just treatment procedures particularly weeks. to get depends two get of times up lot like one things they back, Actually of the One mind is keep back area come back they times remember but good with often of and patient that we're treatment to come of when launching treat invasive to minimally number comes procedure just three another you new that the a on seeing this come into rates a four another come after in

talking just to office. eight the about you're on seven cycle of even weeks the So depending six possibly time baseline

that's So have that -- in invasive but I we about would the talked just that was past something minimally procedures. just

think all Brett. of that. be to I have aware on we just

Brett Fair

Thanks Neal. Louise. Good morning

now is we accounts. teach really the need to integrating right a then hands clinical neck of with component them and for big in position into part sure product to is they that making of patient the with So, integration, them experience on have it expectations the base is the practice. how a product need a about big and said big it right terms the face the guiding of apply Right and to other that get into you of all to of lesion And right It's the you're it. in part it lesions. correctly big now

said Neal what this back -- see is is make offering that before patient a of to kind total practice, of my assessment got you patients. what this my As offering

So it's then be once a of their it physician an other with And expenders a to invite they're the training that delegated party the can the and going into experience evaluation period. period little gets want bit the then because thing, process. to

the lot then that's Once training multiple into these a is you've DTP in doing weight. of the to and like a integrating out from sessions, done doing now carry effectively are everything connecting the there we the and accounts we're of So DTC on that about right the practice. things product lot product where patient

and now place. driving We we're integration we're now between good DTC right in in on October. think a So clinical focused

start I will we come good think activate we will seeing picking think in it place time that the a -- be very you start is when DTC. And up. really I

Louise Chen

very much. you thank Okay,

Operator

our from William Thank Blair. Tim you and from question comes next Lugo

Your line open. is

Tim Lugo

question. the taking for Thanks

you can on was topical, alopecia AA dosing talk about versus androgenetic Just between study discarded? the which the

Neal Walker

AA we studies is Yeah, a of to applying the again day BID, six then obviously proof and patients twice conducting to the so least so obviously results. through months. are more in at extend we're And And giving this on opportunity principle. positive treating of have based in to a all people been date we AD,

use talked for of going aware on we study our I've of in in sound. application. And the to just is past variety of four AD. we're the are really of some I the that portfolio this that's And sense at in weeks makes is where in all looking us We mechanism a leverage the about some that BID know topical work again indications the think well put

Tim Lugo

Inaudible]. [Question

Neal Walker

AGA quite and And that BID actually well. is study. a For that enrolling that's month six is as nicely

Tim Lugo

still I tell I response kind believe for will studies, the that in topical oral? And for open early inhibitor, it of guess too those, for overall or historically bogey is label is response around out and topical rate XX% -- well how to rate Tulsa JAK there that trend versus is the the

Neal Walker

I oral on think right. so treating, Yeah, the it patient depends are the just you

you going Areata So patchy see patients to compressed to if a you just eight have are patient, response. timeframe Alopecia

now. might a take Totalis If or that you a patient Universalis Alopecia little have longer

One to of the things you consider of have is duration also diseases.

more Some to going perhaps to than has treat XX years somebody be year has that's disease who three disease. difficult

the placebo response Oral just in out in work the partial going topical of When is blind than quicker say little going it's objectively But know that. think so and kind this, don't I trials so will steroids label XX% about remember to a lot think rate as is steroids, lower be about open you you that response more I just than complete complex think that number. let's generalization. as to use an just than prednisone response it's a if intuitive and I a always is versus wild rate actually rate. controlled double real the So example.

think with the just need label a are severe time. par are patients responding the that you The things severe So expected. I of less our more and studies and what nicely more little quite bit seeing patients more on quickly open in kind we we're

Tim Lugo

XXX for good Thanks is open, you you clarity, forward accounts into looking or deepen number? had a access Brett guess and account that still base over ESKATA is this broaden are know and that just for citing going giving going how training XXX I you the early the you training I program -- are program, XXX metric are last quarter us or to do physicians to signed be the for the up now mentioned

Neal Walker

we're and campaign. on that so kind account absolutely will -- is heading a into it yes, that's be focused So, of consumer adoption what

we're see market once update that as of docs with You need number. that's will and will people's they I think not with gate. I to the that that time so well a the launch somewhere And of we're of base and have great And really pleased taking that continue weeks vacation, the on the maybe essentially go accounts lot as a mean out to progress. we into of patients today something accounts ads. XX during we schedules summer be XXX particularly the

Tim Lugo

question. the for Thanks

Operator

question Securities. Thank Butt comes you, Adnan from next with our Guggenheim

is open. line Your

Adnan Butt

can patients Columbia see for taking question or thanks AT and of out time encouraging are and you the really studies? Hey to XX patchy AU, and others, and can At how AA versus both Neal growth. AA break you this the many from Australia hair

Neal Walker

the in patients design study at PKPD there. original looking the because because Columbia more Sure, was the in severe we're gene recall so signatures

is with that's it. AT/AU about in with enrolment expand include slow kind In way eyebrow actually looking patients study of they study to the have partial Alopecia Areata patients the had that disease, and we eyebrow at to because started study loss. -- that loss, the everybody because the to So Columbia of usually AU/AT we had we recalcitrant think

nine the patients eyebrow So out of the in study…

Stuart D. Shanler

XX I original think I are from think AU/AT. the

Neal Walker

study. Okay, the in eyebrow

AU/AT. X as the had in out So, up original the the you XX pick study XX that of of so eyebrows

right to gone that that that of And talked we learning's approach, two and just looking you is highlight long this formulation AA just of populations There how out proving study. we matters on in seeing patients severe patient in that the response the So actually I we're one color the of of as rates more and is provide eyebrow again newly part I both mentioned of out them it's phenotype the can and enrolled earlier of a to prove study. always now. really about think have I topical to embarked were see when again we path the way that the have viability we

Adnan Butt

the Neal the is you X so who X saying? what responded, are AA eyebrow patients of patients, that's are in that

Neal Walker

Correct, that's correct.

Adnan Butt

can will it will updated and presented this hair be be the consistency you the is the of growth, by guess of talk pertinent year, anywhere? Okay, the question data about more end I

Neal Walker

have we to Yes, not. remarks has we looking what our it is we that will don't anybody don't believe as and actually or I updating have months we're be prepared mentioned through do during because the six

that we're So we a to a -- going to do it is in fashion. -- cohort want

the time Columbia I present through rolling and of getting X see month thing period first the of first that we treatment study fuller the to with you'll patients data think a is six the way set.

enrolled will that. So, that know the that's way allows multiple us do that see that's open label fact it's but I updates these actually you and just and the have not ideal to

Adnan Butt

the Okay, updates multiple series? in and this so of remainder

Neal Walker

Correct.

Adnan Butt

Last me compare you studies would with and one for the Columbia is, does eyebrow for XXX to exposure what how ranging expect dose and study? a study that the

Neal Walker

it so BID, six dose same is over patchy. that's remember regimen in treatment But the Yes, kind study is it of the range months.

going be might low in therapy I at useful, you're results maintain maintenance disease, be about a right. parallels if the look as end topical oral. the a might in basically It ranges and be the We XX% AT patients how or mean to useful orals to less severe patients at might AU might children, it segment have off you roll the this as And want useful where from XX% on useful again, that be It study. to about market parallels no top-end. at in

we So database. evolves as that's thinking doing things build there's to exactly why we're long-term three the start market study this about segments an to that those four and safety extension have or

our in fast we treatment both regimen true continue the want position evolves. as As learn we've and to we're got topical oral how track a to you know going to approval program about and our

Adnan Butt

you. thank Great,

Operator

you. Thank

Our comes JMP Securities. Donald next from Ellis from question

Your line is open.

Donald Ellis

have quick three I morning, Good questions.

first Trial? then is the feedback of versus free of quarter force are physicians Early ESKATA on The we many the samples regarding in Thanks. kind regarding is Second are in what actually reordering And one question is what selling percent sales ESKATA? getting price, those the implementing how Trial, the last ESKATA Experience Experience the quarter price? feedback question, Early in weeks on your

Neal Walker

thank Donald. off, that question I hand Brett. off for that I will it hand will to you

Brett Fair

Don. Great, thanks, how are you

terms a experience is we on kind in integration and of to product majority of process now orders, training, practice of on account so understanding within the the starting of the and the placed top it time lengthy of everybody about and connecting and working lot to of them the -- on that. the and the in like of dermatologist a the a is and I early So just orders as introducing up board spending ended XX% terms product with them added came PPA initiative Right clinical placing said it patient.

price target we've at In terms coming no not have and of that are group had audience we the our if the price, targeted. the look with problems price you with really, from the orders our

and that are aesthetic they're willingness by in pay tune methodology doing already already targeting those so for purchase procedures, with contemplated reasons, Our products accounts to out patients of pocket.

a early experience our then think at had So of national on we selling, to our that. mean actually with No in definitely concerns I up even really the with I of place we that of in out good all. part wrap coming sales we no meeting. had are problem And pricing. we initiative terms

but -- about early year-to-date, So I'd weeks say the out back of we're XX it experience probably really there just most initially been the for is on selling yeah. cases building oh, of

Donald Ellis

doesn’t have think is I year-to-date? but a that it quarter

Neal Walker

Yeah, year-to-date. it is

Donald Ellis

thank Great, you.

Operator

Thank Liav you next our question from and Abraham comes from Citi.

is line Your open.

Liav Abraham

the us physician administration the trial for of these turning anticipation remind just versus program just Neal, design trial and trials? warts can you maybe office in morning, Good moment. patient of for to your at pace in a and the the the focus enrolment home

Neal Walker

at address Sure, I -- maybe it so I versus to on off I home office. the David. will in will and will start first question the hand

in finish it based gets on the So, line home U.S. office the had of safety, and much but procedure across it And the profile only thought take home would as positioned better and it prescription we the take in approved originally a based particularly we on be the prescriptions. risk was an benefit the perhaps thought about product

And to which disorder better think is general so in this a the address prevalent we population. way quite that's

compared what studies seen these robustly. to perhaps quite enrolled in wart actually think Australia of challenges on terms SK in is we've that we some of more easy doing you're are any and don't anticipate studies more have some in much So of specific inclusion of might the difficulty label that as PKPD I challenge. a open relatively the enrollment, enrolment. might the the studies makes patients They're it have tattooing But different exclusion work or microblading that and wart criteria or just having when like have we had

maybe study In enrolled six we patients off XXX start respectively. to the seven And about studies points. and of months finish to the I completed. about few then last was patients talk end will some to it to XXX Our David just to hand

David Gordon

Yeah, thanks Neal.

wart, that recruit three the practice they of warts. two another in wart, need and X weekend to -- be not end on The the be us have that we for an then were to about and the very will going to going buy Sp they're particular got But very So patients clearance we is hold come meeting. reactivating we'll are which wart, successful approach all get warts the number Phase it reflect going think clear agreed meeting to allow of from to etc. weeks. us of two last meeting away XXX patient that to for have round then each. patients the FDA happy and all And we in from a clinical point as the follow when a to we at us to XX I study. month can one -- X the things They with would number beyond design be point to a NDA with

labeling of achieve the but and that and who the into point if of them achieve that also we warts per labeling clearance and hit one that have we patients think clearance from to based meeting wart of get time the only wart and have that of clearance take other should is we I could number we the way we that could -- agreed on that a point patient have had single statistical warts. we

So as we much saw a that very when.

a we we something clear time year. of in way in and getting that September we start this are are we that on point this we at studies that geared to deliver have think I So think very those can forward

Liav Abraham

can thank and you then moment Great, fairly a of derm topical, that at just I'm that for just is which guess route? what can that administration little trial, a the is you offer you rationale just it's going I Neal, and a I question you the maybe crowded your space others it curious the route talk a your bit atopic on about rationale more is mode see can't, -- for it of that going guess

Neal Walker

a think nice is I risk benefit couple topical far Yeah, profile. of shown things; one has very thus we a are it as

pursue part then you to kind kind sparing the see want from our look is that think I topical whether out to if there's at a money continuing study of on the what also speed the to think in know route. that on we particularly And of day and approach process atopic work that's just determination can we're we'll like of proof about some principle in when But of -- you been we look we it's one itch, of in needs of utilized of JAK in at why front inhibitors certainly quite to far we've going we're investing perhaps the so shown at a bit know And that forward. studies little it systemic well safe the the and need could that's resolution. it make steroids a here. unmet end be of You and the of kind gauges a

Liav Abraham

Okay, thank you.

Operator

question [Operator from Instructions]. And comes from our Jeffrey. Steinberg David next

is line Your open.

David Steinberg

IP, of importance levels protect it does actually could a does those I on forward? it further comment have much. the you the that you know relative Thanks. how you and gotten IP, question recently runway had you very your new mentioned going patent have Thanks product your of on extend much protection. I some

Neal Walker

blanks Yeah, needed. in the Stu let me start and I fill will let if

to street what the the since timeframe. that you So actually even IP have XXXX exclusivity messaged around we've at this the our think has ahead the And at barriers exclusivity IP of beginning if that look I is the place XX base supply at ATI loss to XX our minimum. we goes agreement have you multiple we in of if a where commercial on look consistently

formulation, quite the that claims -- IP based We is the that applicator, about are an agent the And IP. plus all of all things making two unique. stabilization whole to have years broad base that product that's things IP issued entire that XX additional with extension critical package ago encompasses

separate I into base in So XXXX and then timeframe is XXXX's, what standalone, stabilized estate the now distinct hydrogen achieved that that pulling reads got we've us great team IP we from did peroxide. on the our that forward and job takes and a this low think IP have

really talking with. time. have That's when very our stable We about the this, of important, talked product we're this since about It's as beginning you're levels well. difficult to keep over concentration dealing concentrations the

us that was third and win. that distinct is separate It getting the patent. a IP It estate main takes big from Orange and So, XXXX. to the IP Book stands listable

years fact tacked be I we're XX that there, that at We've we of on of know more the think. think should out look to at to least LOE I XX at you when got So that analysis. course kind X

David Steinberg

to color, maybe offer more it then example ESKATA an I give product? some little and I they the how color the could on field. much new of -- what thanks lines know some commercially, but doctors you are is are anecdote in if -- the of us Okay, maybe of from getting embrace push you some back sort early the wondering from willing was

Neal Walker

let answer that. will Okay, Brett I

Brett Fair

you How are doing David.

I little we get account will it, the of so they we've on just lot an I that products to pushback more when bit of pushed it. from as do from reluctant. ESKATA try we understand And think targeted to get those mean were you do have back haven't be a that pushback really those So targeted. pushback, targeting methodology a products people the think on a that lot those the of buying gotten I contemplates

are offer they so delegated Just today really They're Those currently is get is it to We it an thing it's providers positioning how doing reluctant different and that for peer their practice. to us, something their trial that's that the to benefits and it head around trying than sure important area is it are of and time. going, our those sticking a really it then crowd about important to with product practice where how to where because initial are fit in trying the the just an cross safe other can ESKATA. And and make our area we're in they're would where to practice. there to to to surgery picture also critical where positioning. willing liberate to can into this be surgery talk understand go this take the they with the but peer paints sit that

willing peer-to-peer perspective then and product critical there and you So, is those from speak of -- really to from programs one value that the talk a demonstration was to practice. patient product? that bring can the set question sales second live are position theaters the and execution perspective your about we embrace to and all The the

David Steinberg

of of sort Right, they comments embrace exactly, to surprises, just as that anecdotes and thing? sort willingness how on are excited any there any and

Brett Fair

the it, practice. they're within hand gotten fully has experience has treatment and are and trials the patients, and they well with They so the using their starting it them of gone some to initial it in lesions, the understand now right pretty right. so Yeah, it down

really works. Some aggressive too rub you pleased. it. too it product for of but go product sets hard, works I that really the in -- really mean up them this and they term I'm the if And long with well if

and you revaluate sometimes You can it some edema with to get is get the can you that some bread need associated that.

is that new going the right using a lets referenced patient the I schedule and All that right forward they it use and going in say here's and are that they on every you raise so focusing just sure losses expectations. the make how on product, product, the perfectly. types time lesions apply look what retraining you're in So,

with the you but than of had conflict retraining have results quick I of look that emphasis the it's we the excited lot people currently the day So some know the It is about you are of other and treatment, that well, other a response patients using. dreaming, trusting, good. have treatment. with that bleeding they're it's there is next and getting are think do The procedures some easy, pretty a

there's lot liking So seeing it. it a and are of really just them

the right the that's Now patient trying to it's DTC connect play get to to practice and and in role. DTP about them the it will

Neal Walker

this David and build Yeah, Neal, is just bit a on that. little to

have think toxic, the we you break very right. work, it long a lot us derm midterm med doctors strictly from the have And aesthetic been the is about a that aesthetic easier across think a more in more it flywheel bit I consistent into a put time beginning. little to to simplistic it's and way covered and it's does

launch we invasive of So that. and by I and any minimally product surprised think procedure been that's just that's part and haven't parcel

David Steinberg

okay Great, question. and one then final quick

have plate you what or are next the six something , pipeline, out active or in you development. been fairly or have probability have in in What late clearly You commercializing with your in your then a business months so. and but liking used stage ESKATA nine buying so is licensing lot you

Neal Walker

believe opportunistic comment a history assets our we enhance that at is it you mean we're to on we're going So but know shareholder don't value. of stuff a BD, Look we enhance you right. surprise, not I that and look at yeah, things. lot mean with know always specifically I

David Steinberg

Okay, thanks.

Operator

phone from to to conference turn over no for lines further the questions Neal back Thank our you any remarks. would showing I and am Walker closing I like and

Neal Walker

joining I morning. want to thank for us this everybody

the really to been consistent next date this front year. about remain topical for we're to results you that joining. is to pleased on important committed to the market updating generated from Thank that our our condition our We study that first launch. our approach We patchy are and that an excited range with we one on the forward on really progress our we've the program. Alopecia to and We've day of everybody in to really in part on dose forward look out look reporting alopecia pipeline,

Operator

conference. today's may This Everyone you program, the in participating have for conclude day. you thank all gentlemen wonderful a disconnect. and Ladies does

Aclaris Therapeutics (ACRS) 3 Aug 182018 Q2 Earnings call transcript