ACRS - Earnings call transcript Q3 2017 | Aclaris Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Aclaris Therapeutics Q3 2017 Earnings Conference Call. At this time, all participants are in a listen-only-mode. Later, we will conduct the question-and-answer session and instructions will follow at that time. [Operator Instructions]. I would now turn the conference over to Kamil Ali-Jackson. ahead. go Please

Kamil Ali-Jackson

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

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

our Dr. Chief Chris Powala, Ruffo, our me call are Financial today Officer; Officer; Joining Chief our Dr. Neal Scientific Operating Brett Executive Senior Officer; Stuart and for the Walker, Shanler, Chief President Operations. Fair, and of VP Officer; Chief Frank our Commercial

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

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

Dr. Neal Walker

call. everyone, activities company's Thank I our estate. then joining ongoing will clinical you our IP you, in an call. will Kamil. Brett conference with Shanler, Fair, to who off and briefly our Chief it hand third And activities Stuart quarter update Hello, Scientific Officer start I the quarter for on our our third will available Frank and thank will during and will Head the will prepared address and the of third to take Officer, also remarks, our Chris CFO, portion your provide an financial activities our our review After results on open Commercial, Chief Operating update line of Ruffo, then quarter. pre-commercial be our the the we'll Powala, up the for question-and-answer questions. our

you active the December with action we solution is States asset, expected in the date PDUFA are are the seborrheic our approval all for review treatment of Regarding this for XX% of target FDA aware, as dialog the topical in the A-XXX as year, progresses. lead our XX keratosis, and United

Confluence which In the bill is it buy other Life as integration as fillers. procedures activities completed or and track. cash procedure A-XXX Sciences to reminder, on subject a is acquisition and botox pay such the minimally is are dermal not in As to pressures similar our reimbursement positioned August, invasive we

inflammation, of discovery inhibitors. reminder, leadership MK-X acquisition with added Confluence, kino, inhibitor, portfolio pre-eminent inaugural and soft immunology and in a Day scientific early including pipeline a of the hosted ITK engine have drug New inhibitor In and October, focused York. JAK an in additional a we we assets R&D As on the our

a aesthetic we Michael on was thought During the and provided followed have the with the of Gold for Christiano, The work. in two event, our Angela a reviewed here a other A-XXX immunodermatology dermatologist well-known seminal our body research an half of the to-date. on is and R&D leaders for entire dermatology, academic pre-commercial regarding focused Adam inhibitors activities Dr. Friedman. one SK medical work by treatment This we alopecia presentation responsible market discussion detailed the dermatologist who update well-known and Dr. Dr. in pipeline. latter in of JAK the completed areata

we on Confluence who now Shanler, gave pipeline Finally, and plan into acquired advance and I the XXXX. call of expertise our an turn estate. newly we their in other introduced and on Dr. experience Chief an the will which property intellectual technology clinical and over provide management to team our Officer to highlighted programs the our assets Scientific Stuart our clinic overview update

Dr. Stuart Shanler

Neal. Thanks

evaluate of double-blinded Firstly, regarding for clinical you warts. Phase the common A-XXX vehicle of X XX% randomized that two tolerability total in a enrolled with to controlled initiated trials. These compared X of XXX our of dose-frequency have may the enrollment Phase and ongoing trials XX% designed clinical in both clinical recall, were with as the treatment Topical two A-XXX activity, June trials we Solution subjects trials Today, completed placebo. safety, announced

prescription are Topical the trials. patients in medication these Solution position such, steady to self-administering reminder, product a As plan as a XX% we as and A-XXX

in to data trials report expect early from top-line XXXX. We together both

ATI-XXXXX you of know, Topical trials areata. and have and areata, Janus alopecia announced or JAK universalis, Kinase alopecia. alopecia are dermatologic targeting areata disease inhibitor Today, as also in initiated vitiligo portfolio X multiple androgenetic may to totalis both Turning we that alopecia Phase we patch with patients alopecia including two clinical we

of pharmacodynamics investigational data two patients The centers first XX XXXX. vehicle the half blind the as and safety compared in placebo within trial is the of with being Topical in clinical randomized placebo AA. States, This is first United and controlled trial at will conducted double evaluate with expected ATI-XXXXX pharmacokinetics,

will AA. second patients Australia, expected the trial up to open effect centers XX label Melbourne, half clinical also the two on This XXXX. in first with in regrowth ATI-XXXXX is of is conducted eyebrows the Topical investigational in Sydney of evaluate of and The at and data trial being

we a a approximately centers controlled X initiate will also the continue trial the we investigational and initiate the expect within XX double-blinded, Providing trail Phase parallel-group, trail ATI-XXXXX week, indications trial our dose-ranging X Phase of and intend is to ATI-XXXXX from alopecia patients States. next Topical for JAK at a that first open-label is inhibitor is Topical treatment United year XXXX. expected Phase end half in X a for treatment of study a of the XXXX. trial study of AGA third AA. to year randomized, to vehicle with This enroll open-label we XXX ATI-XXXXX, initiate Data vitiligo by in will this additional for before Additionally, androgenetic end

dose-ranging and of in JAK conducting of now additional our candidate currently X trial half ATI-XXXXX, alopecia formulations studies the a are we Phase oral optimized evaluating expect PK/PD treatment first areata, to XXXX. imitate the for Regarding

in in address forms we our other of a as genotypic alopecia areata reminder, disease to dermatologic inherent of As topic JAK developing inhibitors and this disorders. spectrum are dosage both for many oral

our more on coverage I'll press and dates. the scope tofacitinib Commercial related releases Turning message to activities Operations, keratosis. Japanese our loss and to who Aclaris. were inhibitor portfolio the to September to intellectual several that for directed the U.S. Vice for Senior estate, patents of will call JAK continue one our President newly respective I'll property for over and hair patents by to now expand licensed Columbia XX% the issued and detail launch A-XXX for of our disorders. we Brett? patent of you These are issued exclusively treating Brett discuss are owned to patent planning IP use administration pass expiration University including to inhibitors seborrheic two recent refer in the JAK and Fair,

Brett Fair

Thank Good morning, you, Stu. everyone.

As are over sufferers, seborrheic PDUFA treatment patient where treatment FDA to cutting for continue to treatment more the options our the Based high, upon December for that million freezing. about approved face market highly lesions or for is burning the SK we lacking. not our pay opportunity is condition likely a With for like motivation excited XX, yet involve patients research, current does we we date, understand located to is is prevalent approach in sensitive keratosis. cosmetically less XX scar launch and be to areas willing first treatment are that

the on invasive people for A-XXX. and minimally willingness the aesthetic suggest market that for there findings of over this A-XXX. research out with treatment SK and pay seek growing believe have a market motivated recent favorable treatment with intersects were in to dynamics creates trend lesions face X Our well to like We procedures pocket million are

In prepare we we In all regional of performing records. we October, met excellent track hiring approval an the six terms as goal infrastructure sales remain our A-XXX. for build, with top track on of and and launch anticipated managers, relevant of experience

recruit team candidates process, the with our they who support well successful interview plans bill sales and high force to are business With respect interest and to as begun received rep the from develop Aclaris onboarding regional launch very eager initial experience, to product. help us this have XX-person successfully their we training launch. positions, join a level sales of relevant Following and to dermatology buy as

in the We and of the letters reps sales are currently in will extending offer process onboard January.

our themselves to to terms approved market opportunity over I'd excellence make the of In activities in-services summary for and first QX that, approved speaker strides as well advance readiness the the reintroducing and key programs, and update turn we the call reps Frank? launch promotion label, to and or and to the continue sales treatment excited centers as Frank to to establishing about we SK will target activities. activity. with trade our with initiate launch as Market we infrastructure include In readiness excellent introducing launch build like Ruffo, scheduling With use we the providers. readiness FDA are CFO. of readiness, accounts, materials FDA

Frank Ruffo

Thanks Brad. Good morning all.

As financial be in found release. today's through I can third tables the quarter reference results, press that you please take the financial

the net quarter in third $XX.X and for During of for to $XX the the was quarter million XXXX our of to XXXX. compared our $XX.X compared total were $XX.X same loss million third million expenses operating million quarter XXXX,

to recorded during in August related acquired of year. revenues third CRO business quarter this $XXX,XXX the also We XXXX of Confluence's of

the XXXX, were last to compared million operating while $XX.X our nine same $XX.X $XX.X expenses million our period same in the nine was for period months million month total compared $XX.X for September XXXX, to For million loss ended XX, net year. the

XXXX, XX, operating was $XX.X September Turning towards cash ended our flows the cash for nine months million. burn

Additionally, between new net cash offset of cash we our made Confluence upfront million for $X.X equity net proceeds payment the by million our issuances outflows at-the-market common approximately from stock were acquisition, a These in of public existing facility. August offering and acquired. $XXX

increases affairs program XXXX. compared primarily activities $X.X and in $X.X XX, and equivalents XXXX. for hand costs has $XXX of As a any a related offset JAK an to aggregate effect medical SK payroll million was $XXX,XXX and completed with our program expenses, in fees in to drug and last the General increase $XXX,XXX for the related These XXXX by costs, balance R&D operating clinical change million marketable we business professional million R&D program trial in for third related quarter fund September into lower in trial and year. sufficient Other in Without costs for that initiatives costs, cash increased were associated increased was result A-XXX QX of stock-based or expenses $X.X of pre-commercial primarily an A-XXX A-XXX the $X.X increase $X.X security XXXX cash partially cash, increase giving of activities, was to our in Confluence to discovery. result stock to administrative This expenses balance million $XXX,XXX in million clinical our warts. half in current early-stage based period the in financing current were are compensation $X.X new in development by a million and to increases $XXX,XXX increase with investments sheet second by on associated XXXX which the transactions compensation same believe SK, and expenses million. the compared attributable in our acquisition. payroll XXXX. This approximately QX

the guidance are full We updating our financial year XXXX. of for

Our business estimates now operating our include XXXX. the X, since of Confluence results August

the to are for versus paid of of $XX the now for We compensation or year's prior million stock Total $XX be estimated operating for our range range excluding $XX acquisition expect to be $XX million expense in when burn to in $XX cash the cash of $XX based this the to to financings $XX million guidance XXXX expenses Confluence million. million and excluding million estimated to million $XX XXXX of million. million $XX

$X expense for million XXXX in are estimated operating million range or $XX $XX excluding of $XX current for million and guidance stock-based when to $XX to estimated be $XX $XX stock-based was now expenses million to to Our Research million. million. million million in the million compensation million $XX when of $XX the range or $XX compensation development of to $XX million excluding to

had $X to million we The expense $XX common R&D million XX.X million for to stock-based of shares when XX, guidance prior Our September stock $XX outstanding. of or million, XXXX, roughly $XX million $XX excluding compensation million was million. $X to

equity, share and Neal calculation count weighted in full expect material shares. basic no diluted share million call issuance Assuming remarks. closing the average XX.X about of the some XXXX loss I'll to our per be we back for over now used turn year would

Dr. Neal Walker

Thank you, Frank.

has develop a to company. into continued full-integrated course of XXXX, the Over biopharmaceutical Aclaris

and in drug commercial We discovery our our grown capability immunology organization and acquired out expansive added and portfolio, inflation to developed infrastructure. build have R&D world-class continue

catalyst you foundation in Company multiple a to is heavy novel And for excited our as therapies developing questions. on growing look dermatology. a today's commercializing to outs. solid team are Thanks deliver capitalized in plan is and can being please call. have with in XXXX We to pipeline of well Candice, on we continue place read poll for The year

Operator

And from our [Operator Instructions]. Seamus Leerink first Fernandez question Partners. comes of

line Your is now open.

Seamus Fernandez

Thanks Great. for guys. questions the

the the things, that of dynamics a just few of in updating an trying thought of terms have more guys formulation you the Can again oral the bit are be give slight bit that oral what the need always move to a start of of formulation Just do studies. would sense like topical, the really formulation? quickly. general out I us little you in the push what even to optimize and actually the more topical agent you straightforward a a forward looks and

how So, around just trying to issues of you get to the the are trying a are better what and that. sense formulations optimize

that of the relatively JAK initiated an having is trial, number on just a queue? in with of R&D you update update second patients. just us, can in Australia think later The some the that small your – Can question follow-up specifically us data and topical is inhibitor least at been you when I in as of mentioned principal you from anticipate we I'll you Day, preliminary proof there at questions that's ongoing would study

Dr. Neal Walker

a of year have full we range, important, think step next think terms JAK the given the you of of about absorption. lower Yeah, dynamics consistency of beginning push-out think in I so process correctly, you to the inhibitor through to it. down we the doing has of is the it of minor a study into we it's appreciate Seamus, range kind went the complete. capability the earlier proceed we dose are know in more you year, Phase end previously And start. so the when to a the X, on in a drove oral before talked of of nearly the dose formulations in process PK/PD we're characterized selecting across know couple optimizing that it's I Thanks as and had the an And taking we formulation space additional in we

the Topical is formulation want we've question, XX data discussion we efficacy topical that that the the third we a as first quickest on in demonstrate whole the read-out, expect the I the our can and that patients, was conducted quickest in area it early that think think know the key with – on with initiated the where on designed the was probably it's were back been first we half. guided PRO had, we think anticipate that key as get half, has in we in and to there and open-label, manner, we works topical that – second I and FDA on your eyebrows we you the data so to we so show identified quarter,

Operator

our from next Instructions]. comes question And [Operator Cantor Chen Louise Fitzgerald. of

is line Your now open.

Brandon Folkes

the how how aside of Hi, that it's Could thinking Louise. are the economics And solution neck, is other and then you where you and for us SK to are Brandon the on Folkes favorable? topical just treat for face to just doctor on areas doctors to for A-XXX you body on provide using guidelines giving it about you're SK SK. any secondly price there from

Dr. Neal Walker

Sure.

thanks questions. So, those for

pricing and further typically guided On XX broad refined that the pretty front, towards is to of that's to XXX guiding range. the XXX work a that doc. range to guided to upper of and the We've year. we XXX. far the what we've we've We've refined We so been done end further not that price pricing

in or that this changes area course face the economics to think premium know of on pigmentary I pain, at but warrants we're across perspective you pricing. aesthetic subsequent refined value the less can't premium we upper be you part sensitive body and neck, and you aesthetically the the and obviously of of think reaction the areas. providing there. body, deserves less obviously I local mainly from all focused our the of see all-long of we getting it's was SKU entire – use range. our you R&D end are gate, and more are think SKs We focusing aesthetic studied result guide think the tool conducted, clearly tool, on prop the a out a most has PDUFA better over would Kaiser to the so to the skin remind a develop presented doc, in that pricing, the we The we that face better scaring, more our pricing from of to such it studies, to the been the date, pricing But study of as on data guiding neck Some and we'll was the propensity because that know was value those that and Day and I I

our that's the So, thinking at moment.

Operator

Thank comes Abraham Liav our from question you. of Citi. And next

is now line open. Your

Liav Abraham

other Can expand the little A-XXX your on for launch SKs? make think source therapies preliminary trajectory about. but you or you at if just commentary secondly, after, And launch know after program, any administration I your there's this morning. bit could should little and after at warts are know we strategy any already to at be you can give when and a that patients, looking trial can if stage? thoughts more did be thoughts will who a don't or be you Good start I at – Day X dissatisfied, going Phase you then on going as to in about additional talk patients home how the the the on going strategy some trial, Will the you whether you naïve physicians-administered bit and gate see we of initial design, on the trials? R&D

Dr. Neal Walker

question. Thanks appreciate Sure. Liav. I the

two your off I'll wart to first So, answer Brett it questions. I'll to piece the hand and

parallel program, December. first going a complete studies other the one So, of on dosing twice – part do just the weekly have do weekly. we on, study back a as we that actually we and reminder, in wart the is two to is expect the And so

in middle Phase when meeting Phase both in end of meeting, study, given the weeks an would The January. of the choosing and anticipate of of we're think next the know part year, same three X if back in early about you time starts year. date end the to other part year, or Phase the part if and behind kind again, and of X And is we we is frame of X getting X happens about that end starting report trajectory, study the out the anticipate so two, weeks, two Phase a middle we PhaseX in of meeting so positive

the cadence. to that's think about that way think I So,

design, In is the appropriate give that you some trial changing trail our we in Phase the for design in had relevant study, FDA terms Phase don't is anything know us guidance design dialog of see X to the so and the insight we think good that there. X telecom that on with you anticipate we

have clearance. range four we know, obviously appropriate you something to and warts to five treat think going demonstrate to You of the on one are to

it. a the lead know X design what trial Phase see Brett, little in we'll initially that's moving you it X about off And work, I the to So, will we designed asset how reflect the to reflected think, hand launch. and forward. bit Phase talk I'll the

Brett Fair

Neal. Liav. Thanks Hi

burning. will in of we've other terms launch had naïve don't Based will an had for freezing or and alternative. veteran like patients the that have very it's off to patients it opt we're So, cryosurgery doesn't important or be them or both. modalities, cutting involve token whether would done, naïve strategy looking that for the those same be on patients, do. the Yeah, what work It

cosmetically suffer, urban, and younger, that as and is neck is this be treatment for that know areas them as [indiscernible]. function consumer patient when face aesthetic they a Our drive into that like SKU sensitive let you we're of treatment, and a product, target that, of solution them there that educate the and positioned will and keratosis them demographic they seborrheic naïve available many suburban be in them instituting what this an those will SKU on will

application accomplish to and in clinical can training integration set they the guiding account in related managing to In – first patient, two has expectations. the that right that an and up we terms which the well to so the take off. the that trajectory, of launch And it's to there's really fact things lesions because need in is need

we incorporate our offices in-services that also and launching of is and training product terms whole it. whole to the and integration on practice as They what they do minimally into the this other So, the do we're guide too are invasive there business with how understanding then that doing know procedures. already to will the And practice there established a early patient. to the there get, exactly in is component with

integration, But business our practice. got of band I work it. doctors, the terms next of integration, into on will In business they integrating

So, little that of But each flow you of a time. accounts turn once volume you wired up takes for could then up bit the get sound, will through. and these and the patients

So, curve little the it takes a bit smoother in beginning. longer launch

Dr. Neal Walker

build dermatologist comments, of And think just to I this such, a conditions on one see has that most everybody little and common the as Liav, some bit Brett's remember, I of is to question SK percentage think you a and not large been know of in patients the your but quite treatment even patients treated. have is had have who've actually past, have they don't appropriate,

effort the think an and educate tool And we're in them aesthetic first launch the campaign to the in in process better to early DTC reason sequence the available one and year, patient, on so, – strategy. there I that's and opting part an have understand is that's integral a that of of the that's make

Operator

Everyone may that thank gentlemen, you answer today. for session in Thank today's Ladies does great call. conference and This our and question participating you the day. all disconnect. conclude you. program and And have for concludes

Aclaris Therapeutics (ACRS) 7 Nov 172017 Q3 Earnings call transcript