ACRS - Earnings call transcript Q3 2019 | Aclaris Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Third Quarter 2019 Aclaris Therapeutics Conference Call. At this time all participants are in a listen-only mode. After the speaker presentation there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Kamil Ali-Jackson. ahead. go Please

Kamil Ali-Jackson

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

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

Executive Frank and call our Financial Chief Officer. Dr. David Gordon, Joining the Neal President our are me today Research and Ruffo, Walker, Medical Vice Officer; Joseph Monahan. and Chief Dr. Development, for Chief President, Executive Officer; Dr.

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

reflected forward-looking involve are materially that cause that actual Our results and risks, changes those such upon expectations differ uncertainties based circumstances, assumptions could in statements to statements. current in from

These makes today, in under These the XX, www.aclaristx.com. of with and Form the Financial Aclaris' Analysis September XXXX, filings of factors risks year December website are section and Form page to XX, Aclaris' SEC quarter ended the at of Condition Results time and filings documents of other from XXXX, the sections for ended Operations filed and SEC described for Management's of available Aclaris the and XX-Q discussion time. XX-K are the Investors risk

events being call that may otherwise. conference to this webcast. Investors advised on in the today's any today, we obligation our webcast and link on to on and the update information, posted of be the call All new Please of information we statements undertake provide call is A future account of section is as recorded this website. or provided we forward-looking no make

Dr. call I'll over now and to of Aclaris. Neal Neal? President the Walker, turn CEO

Neal Walker

earnings quarter for joining call you, third us you, on our and everyone, thank today. Kamil, Thank

The our a busy call and productive development our commercial third On maximize we deploy a announced review and quarter to strategic both as quarter. assets how earnings our quarterly return. research to August, shareholder capital of well portfolio last of has to determine been optimally in as

September, announced our on plan immuno-inflammatory our In partners programs and would business. commercialization refocus that to our we seek the we commercial actively resources legacy and development for dermatology products

eliminated of strategic the As we areas by our all workforce across part and over reduced certain programs. review, of the XX% development organization

looking cash EPI divested we and are today, ATI-XXX, common alopecia. to actively other ESKATA of and Topical assets and including Solution million programs, runway have retired to As warts, extended for XXX $XX for debt, Health, XX% partner our RHOFADE in A-XXX

a adults. as common Rx it highly our Rx were if at-home As approved be affecting be channel for approved, studies an a with endpoints. III pharmacy product warts, traditional the reminder, Phase would statistically prevalent XX% use. highly in both product, convenience of FDA is warts significant Positioned across indication And A-XXX first the the all both retail distributed common children will and through it

renewed targeting small discovery XXXX, by quality design molecule on team, focused world-class competitive speed, in a targeting specialized therapeutics, to effort now R&D a market, that oral our for of can The is is multibillion-dollar be versatility. we forward kinases our platform, specific basis confers believe look which the are capitalized designed and or innovative, KINect to led execute site for use. we immunology and R&D proprietary As our advantage we of on sufficiently the kinase-targeted in opportunities effort,

translatable and of testing kinase success. of As a decades drug validated is integrated kinase from design, layers reminder, built a discovery inhibitor uses library KINect fragments funnels that of drug an structure-based system proprietary

is already the irreversible as ITK approach We MKX as kinase effectiveness our design group well substrate and inhibitors, as tissue drug versatility of demonstrated reversible irreversible the the realized inhibitors targeted, are our and in of candidates. in success confident selective by

in X initiated is year. ATI-XXX I inhibitor progress clinic MK SAD/MAD Phase to internally and or the this first enter developed novel study good making compound the

be IL-X. goal other Assuming well the as success levels profile of such of in the IL-X rheumatoid which by IL-X I, that to next Phase the alpha, study conditions are potential extrapolate demonstrate to TNF with high us provides arthritis, into also will conditions beta, characterized characterized and pharmacodynamic in various the inflammatory

also will In pursuing inflammatory be will second that indication the with be identifying a coming months, we ATI-XXX. we

in advancement. In and covalently addition, pre-IND kinase soft-JAK we have other inhibitors in bound our breakthrough ITK/JAKX

Given opportunity broadly focus landscape. mechanisms that believe immunology immunology to have the reshape in formulations oral novel in the potential the unmet space, the we continued needs exists for the

JAK key IL-XX biologics positioning as well injectable of established including candidates our inhibitors. the drug is A of rising safety oral or anti their IL-X parallel with potentially efficacy drugs, anti to exceed feature current mitigating beta systemic anti-TNF-alpha, high-value and concern the as

call, review later ended the $XX the get million, sufficient As this third the detail with of we more quarter quarter Frank XXXX. in in to and to will is third us

that development activities. gives effect or potential to transactions reiterate no additional this financing to want I any guidance new business

we cash our out execute that should we date the anticipate only on as business development so plans. And improve

are deliver in As in we the a reminder follows. our budget catalyst as XXXX to expect current

Phase in inhibitor, the with early I atopic Phase QX. in ATI-XXXX is an IND and trial XXXX; if I/II submit IND to successful, of initiating of the And moving SAD/MAD tender, II readout that and our in soft-JAK the half by have half subsequent first late is will a the second in early of we ATI-XXXX, a Phase half arthritis rheumatoid second finally, third to half in XXXX, an or candidate in of XXXX; then data For initiate then the which ATI-XXX, data an first plan bound year-end ITK/JAKX covalently in initiate, submitted XXXX dermatitis XXXX, and XXXX; trial a

you will I on will our who R&D to that, off David update CMO, With progress. Gordon, hand Dave? it our

David Gordon

the quarter afternoon, month, Last Solution R&D perspective. warts and results potential Thanks, A-XXX we of a common for verruca everyone. the from for from and clinical treatment development announced III successful good Phase Neal, vulgaris. XX% We've our successful busy had or Topical program

refer you included studies in secondary primary would to as and endpoints all III high known met statistical that I endpoint data THWART-X and with in summary, the efficacy announcement, Phase both THWART-X, but significance. the

be Mild A-XXX of that prescription to under of events. will up first moderate support medicine has believe majority application and adverse an for potential events the the made We THWART-X FDA-approved common vast slight all NDA adverse warts. to treatment the XX% THWART-X

so Phase a III patients the deliver of of prescription to common successful program proud trial. I'd this warts. who in like our first treatment and thank for to I'm participated the that investigators worked team hard

TNF, and Moving ATI-XXX oral IL-X is our to investigational inhibitor, pathways. IL-X our immuno-inflammatory MKX molecule that pipeline, targets drug small a

multiple half from underway. SAD/MAD we the and filed quarter the for single the end Through IND I are dose by first of first study In is successfully well the or data this expected XXXX. drug XXXX, and program ascending Phase of the

which The a of and target update will next you with for IL-X, will rheumatoid be initiate II also the we the inhibition after considering number half expected to TNF, the XXXX. is trial Phase a ATI-XXX Since arthritis indications, IL-X, we to first on of MKX study IL-X additional SAD/MAD step inflammatory in of in coming are in subjects months.

a severe our are developing ATI-XXXX, pipeline soft-JAK immuno-inflammatory treatment is which dermatitis. X/X atopic potential we topical inhibitor, as moderate second Our for to candidate

of topical XXXX which studies class to if it that forms. of JAK be passes context demonstrated the that the efficacy atopic to with A non-active quickly formulations. oral of means any and its In refers systemically, in have soft dermatitis drugs metabolism will both drug metabolized characteristics, number deliver

Aclaris atopic have a dermatitis. a to previously study solution topical reported good inhibitor, of patients open-label with of a rate and severe ATI-XXX our JAK that X/X delivered moderate response small

JAK that we inhibitor atopic in with may taken inhibitor of efficacy, systemic to are class utility systemic a safety while local related balance believe we exposure JAK We the drugs. the approach The exposure. good ATI-XXXX of but concerns reducing dermatitis, have very provide have aware will of

Phase in second on atopic XXXX. moderate patients are the of to I/II enter track We half dermatitis severe in to with

molecule are candidate, QX molecule, ATI-XXXX. mentioned QX This or briefly a will potential inhibitor, small I'll in diseases. progress small as ITK/JAKX XXXX an treat cell-mediated which The immuno-inflammatory oral It's XXXX. to to third has as IND an pipeline oral T

previously made R&D a our had on focus decision we that spend we to strategic announced our Finally, immuno-inflammatory portfolio.

ATI-XXX being As develop such, are further JAK and investigational we our oral for developed X/X partners were and topical ATI-XXX, indications. which to seeking currently both of alopecia inhibitors,

are to I where review close, posted on the Day Before you the our held a This our of September, pipeline. that at slides website. meeting and our team immuno-inflammatory we was like I'd showcased end R&D encourage to

With pass it to I'll Frank. that, over

Frank Ruffo

everyone. Thanks, David. afternoon, Good

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

was please For MD&A further XX-Q section filed the our detail, Form to today. in refer that

note from of face our to current the the our result sales about statement. in prior are year's P&L strategic the operations item, the refocus our and quarter's the from decision to historical discontinued summarized programs, a immuno-inflammatory review financial revenues First, on our presentation, resources development expenses and our and of product as just statement on line loss our

of in Please balance for items. for XX-Q the our operating including items, related our included financial in our Form marketed XX what sheet reference the of line products details these and statements footnote results is

of XX.X of $XX.X common outstanding. As XXXX, had of and XX, shares stock cash September investments we had million million and

net XXXX, used in For activities the September months XX, $XX.X operating cash million. nine ended was

sufficient additional effect from the fund we into including Earlier without quarter of or operations activities. our anticipate our RHOFADE sale in with financing until have proceeds new extend this the current We XXXX, runway the the that of any given of of potential cash giving and now fourth business our our Oxford the XXXX, will to guidance of that the full capital third transactions upfront repayment facility October development capital, to year, both XXXX. loan runway was quarter cash

to to include expense XXXX, $X.X These total for the quarter expenses third switching of million of period. year. approximately noncash our compensation $XX.X million operating Now stock-based our compared were expenses, for amounts last of $XX.X million third the each R&D quarter in continuing

III a were for mainly programs trial payment achievement the the at offset increases milestone end wart Phase million our spending for specified were the preclinical ATI-XXX. as year. of various JAK $X Phase or our programs, trials for The activities quarter increases development with these a These milestone partially inhibitor initiated I and completion made as at third Rigel development were the Phase well to near decreases clinical II recent of result projects as this associated in by clinical for of

G&A For quarter noncash last of of were year, to the million, expense XXXX, included noncash $X.X of million This our of the included million. stock-based which approximately $X.X third third compensation. compensation compared expenses $X.X total for quarter which million stock-based $X.X

by decreased repaid due on to $X XXXX October Other of October XXXX quarter to of expense borrowed million interest as third about which last compared was in income debt, XXXX. subsequently the outstanding and year, net for third quarter the in incurred our

operations was million Our loss XXXX $XX.X million from for of third for $XX.X continuing quarter the third to quarter the XXXX. compared of

compared third the XXXX, nine compared from the the discontinued months And for was ended XX, of quarter quarter $XX.X to million ended September year. $XX.X million operations of million months nine loss XXXX. last Our for XX, for million third $XX.X $XX.X for XXXX was the to September

XXXX. months to item million And of the discontinued ended $XX.X for net the XXXX, in and and operations. XX, million $X recognized RHOFADE just main nine quarter draw from items of your September loss to few sales third for attention We the line

We also months included write-down XXXX. related in recognized $XX.X to onetime quarter the both of charge RHOFADE, September third the million noncash intangible nine a our ended XX, asset impairment of and for

operating we strategic of expense commercial of be our to year represents longer result no expenses estimate that operations, believe do would prior a not updated our for discontinued meaningful. guidance year related As XXXX our products and an our direction, reclassification estimated anticipated of operating which full accurate in the new XXXX into full guidance resulted expenses,

rate move our on XXXX we trials burn for But based as three of decrease operations from as XXXX, costs wind-down as our we during as exit the this complete discontinued cash additional our first related significantly some experienced to into we plan, XXXX, quarters we quarterly costs year. A-XXX, vendor well the II anticipate from burn Phase various XX% to some alopecia continuing and and But our employee to and operations expect trials. current the incur clinical to

our fund assumptions, third on current transactions business estimate activities. these Based operations to effect will without our XXXX that to additional capital we any giving sufficient potential quarter the into new or be of financing development

closing few call now a for back to I'll Neal turn remarks. the over

Neal Walker

Thank you, Frank.

the clinically over significant quarter, the in common and So R&D highly of lot studies two pivotal Phase to warts. execute but third obviously meaningful had the a change we've III statistically we continues on side, team produced

We we we vis-à-vis, where dermatology focused And down we and coming continue forward St. a in to we as work one Louis. on our and of the a stated reporting focused advantage the in months. from immuno-inflammatory diseases, competitive our to manage company pivoted our be expenses, now will on looking strong programs today, believe to have team in we'll SAD/MAD three be results investing we

that, With off to for it questions. pull I'll to please Josh hand

Operator

[Operator comes Instructions] Our from with first Cantor. question Chen Louise

You may proceed with your question.

Louise Chen

my taking few. thanks questions here. Hi, a had I for

of and or the blockbuster first there you most you commercialize, question What or then potential you. your is kind my yourself? this Thank in So is differentiated then economics to ideal your And your that pipeline, is going US, Or these? And immuno-inflammatory ideal types pipeline? of to is are for excited you what partner are of valuation in what of terms in view? assets? do immuno-inflammatory have product left assets that outside have what you are And so, an develop and out terms about products who in for could these the think partner? if you something are this most

Neal Walker

Hey, question. Louise, for Thanks it's Neal. the

take order. reverse kind of So I'll it in

given also T on X having and have indications assets to we anti-TNF, beta, receptor. the of think cell with soft-JAK So targeting anti-IL-X we would mentioned, ex-US look a breadths side, after the that the then I topical going at the that

at companies to be that ourselves. pharmaceutical pursue We looking we wouldn't would with be partner rights larger basis. to on a absolutely partner would would we look and of think ex-US, I sorts something these country-by-country

on some from now assets, the we're on valuation are Relative comment that. valuable specifically. they're we process BD Obviously, that perspective, formal we cycling of on that we to in question on assets and the a think don't a

your like forward are then often about, isn't And what in So everybody terms season it we'll anti-IL-X and MKX be effects therapy first potentially looking to beta. comes on anti-TNF can asset an our excited can at that along we you inhibitor most oral that mimic in think, get the you of updating front. progress on question, biologic that the that an with have where mimic, I one

companies And think always being oral, at. looked I a of an have that's been that something lot

results, a at we will if indications out it So going broadly of gate, we to the think, we're think although we're applicable. be see, looking of couple I see the

the I largest got that very a the So team SAD/MAD broadly I the finishing just to product. asset pipeline work, is a We a are for that think kind way and status a for potential is potential of product Obviously, we've and think down but about the the long blockbuster excited road. go. has

Louise Chen

Okay, thank you.

Operator

Sarraf Our next Thank comes with you. from Instructions] SVB Pasha [Operator question Leerink.

with You proceed may your question.

Dylan Dupuis

And wind look expenses? down? for looking how to the to in at? considering what Pasha. how completing near when this operating like the be wind is down Dupuis And down, of comes should term does This more model Dylan in sitting timing One for much wind of a it you question terms

Frank Ruffo

So the this for is Thanks question. Frank.

down, think you wind QX. us I And of couple in the quarter. we're of mean, lot when wrapping trials talk up just is that I fourth in a about a behind

first less the would year than into spent burn year. it'll as headed less then where – obviously we're and – a three in what we So head this be of where be next bit little far quarters we

the – think some for down by wind in the the the costs items, will end of wind most up quarter. I around the So personnel of first severance-related part they'll the and

of mentioned significantly our have in going a we're next then have a a a burn on year, that, lot. to not I whole little And rate basis. remarks, as And quarterly bit lower so we'll

Dylan Dupuis

Great, thank you very much.

Operator

turn Thank further over I'm at further for you. I any call And questions Walker would time. not to showing this any like back remarks. to now Neal the

Neal Walker

our updating coming SAD/MAD Josh. forward call you Thanks, to the months. this on Thank the Appreciate joining evening, look and we'll you. results in everybody

Operator

gentlemen, today's Ladies concludes participating. for and conference Thank you. this call. Thank you

You may now disconnect.

Aclaris Therapeutics (ACRS) 10 Nov 192019 Q3 Earnings call transcript