CNCE - Earnings call transcript Q1 2022 | Concert Pharmaceuticals Inc

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Operator

Good day, and thank you for standing by. Welcome to the Concert Pharmaceuticals First Quarter 2022 Investor Update Call. [Operator Instructions] I would now like to hand the conference over to Justine Koenigsberg, Senior Vice President, Corporate Communications and Investor Relations. Please go ahead.

Justine Koenigsberg

Good morning, and welcome to Concert Pharmaceuticals' First Quarter 2022 Investor Update.

will Q&A so portion today right can comments the into of prepared be we brief, jump Our the call.

morning and Financial the team this President Cassella, Chief Operating me with Q&A. will are Jim remarks Joining join Officer, Roger Officer; and and CEO; Nancy Marc Officer; Chief for Development Becker, Stuart, Chief prepared Tung,

actual on our are as can As results call. would I of that plans and the expectations, a our like about future of uncertainties most from materially SEC. With today's no to reminder, to differ in with and now only these and turn These date, made speak assume to we discussion subject statements statements those statements any today's may recent today's update description risks will cause be include filed forward-looking A to obligation Roger. that, Any call prospects. projected. XX-Q over found the to forward-looking statements forward-looking risks

Roger Tung

an Justine, well or SALT percentage The represent the XX, our clinical the weeks. Phase is equal finish and assuming success, to randomized, placebo-controlled, and loss. have score results doses clinically believed from twice Thank study in to of Both XX line of joining X of for or III are patients and endpoint primary is safety this placebo in than milligrams coming evaluating trials XX result. milligrams with is line. our XX meaningful hair compared XX CTP-XXX, a which old bringing CTP-XXX efficacy clinical file to trials Phase studies NDA first aged Each we're to less XXXX. X focused of XX% And the we to today's years of pivotal greater the scalp and THRIVE-AA on adults absolute top who thank half during achieving for evaluating daily remain positioned for you, CTP-XXX next With our quarter, of update. you, everyone, the us III multicenter double-blinded,

include its top the future present safety Our more that We'll data. study our line look from study, findings score data key X-milligram a Recall and equal less proportion meetings. to than and endpoint from in of achieved medical primary a will greater significantly THRIVE-AAX twice-daily dose-ranging to with at announcement XX-milligram doses Phase patients both of placebo. to detailed XX the II SALT or relative

which score no measure of scalp of the For while familiar those SALT by X to the not The XXX. alopecia XXX to or of score hair on hair severity from assessing amount loss that a to the score contribute tool, scalp. the to of total total the of ranges SALT X scalp a with to corresponds loss SALT corresponds hair regions of scalp coverage it's determine X

will up has approximately As it with the II a we and overview having shared patient results. to with long-term profile, working financial have with highly to that provide Currently, use. being inhibitors II safety for its be I'd given believe areata Marc, turn intended of alopecia Among market, could and discussion open-label areata. to of a there observations to Even in be hopeful need an like to the alopecia clinical and bring III the potential possible. moderate-to-severe competitive treatments. million appear X.X the treatment subset sizable alopecia JAK the in developed to profile there extension areata for treatment patients past, the no FDA-approved in who U.S. are players alopecia areata, other of disease. We're and effective to as profile quickly durable with CTP-XXX Phase CTP-XXX seen a here CTP-XXX, results and potential will patients blockbuster will consistent that the date it and extent we're as our we've well-tolerated we pause Phase with our results in of an confirm the Phase of treatment generally our the the

Marc Becker

Thanks, Roger.

XXXX found and results, development financial in XXXX. quarter please million the first I release. As quarter the $XX.X first Research tables of and press financial compared reference today's our expenses during the million XXXX during to review $XX.X quarter first were of

year, continue General The million While have for administrative extension the costs both North are expenses and is down were of with first we and American associated to trials XXXX. winding III extension the studies. 'XX until Phase to approval. clinical open-label this study $X.X the quarter continue expected

the was $XX.X million quarter same the share share first net ended first equivalents $X.XX for per per compared $X.XX Our We XXXX period investments, million to into in current loss XXXX. of a net the the in to which of or and operating cash, $XX.X million expect we quarter or of with quarter $XXX based for our loss plan. 'XX fund company cash on fourth the

upon potential exercised, first AAX additional full exercise If will runway extend cash is were the half million The our anticipated issued XXXX we We readouts. our to tied expect data are an filing, that THRIVE-AAX which for of the receive the warrants have warrants and to $XXX are XXXX. planned in beyond financing. the the November the NDA of warrants fully

any and NDA We've the release this This advance very quarter. candidate moving concludes and an is filing point an top we year. for remarks, prepared as would our happy questions. address we this the to success, at to exciting hard be toward are line drug prepare team worked THRIVE-AAX assuming CTP-XXX excited We next here to data about company inflection

Operator

Butler question first Jason Our Securities. from Instructions] [Operator with comes JMP

Jason Butler

a XXX with data from just bit could label? for be class then approved and for the to the how landscape, little coming FDA the obviously based XX? on you SALT plan competitive looking to safety approach current frame just language products mean what And we on with Maybe regards up. should just the more the on thoughts you the I again, excited

Jim Cassella

Jason, Jim here.

saw II. III Phase our consistent what So for I our we our think Phase expectation with for trials are

what in think is for consistency X-milligram on readout we're the I and looking XX-milligram the data BID dosing. So

in of trial which II we design what to trials very think had I in us good So is similar III, our gave couple Phase our have we Phase for saw in dose-ranging a that We confidence trial. experience.

So we're and the design had data Phase with with the feeling entering comfortable pretty I study. we think into our III

our I good looking had there in consistency So we're for think consistency II a as trials. we Phase

seen and I the competitive there competitors landscape, Lilly Pfizer think data. you've with out are

is data with III we'll very expectation we've seen results. II in our and I that what think Phase our consistency with is our Phase competitive see

for the put and JAK as space. atopic the far as has goes, across FDA derm think dermatology I safety the inhibitors out language there

areata, to I everyone's there's drugs FDA think think coming the going a difference JAK that to on I with for position with approved grips alopecia inhibitors, little there's no where but be alopecia alopecia difference the I There that will But be be significant think need. drugs. is of treatment unmet some might consistency areata. the medical the the a across in language areata safety

I mechanism in think alopecia important inhibition treatment is JAK the a very areata. of

very a areata. in And shows across terms important mechanism I as here. inhibitors treat patients that very to for So of the important alopecia think are JAK mechanism the it's field the data

a background as I on at So of from safety consideration areata look has perspective. that's important for we a what the think the FDA very alopecia

Jason Butler

have Can the starting the place you're medical now being get just and you putting speed one little your and education Great. to affairs, physicians set? a me. in speak medical more data aware And planning once for data bit up on for the of that then and to you to product

Jim Cassella

Sure, absolutely.

of as thing a a this As interest just area lot One for we of as background is with us. it's you in active a are KOLs can the very bit space of trialist. imagine, little working

these have are very a a treaters. of the lot space I the as clinical trial. representation experts the with are in KOLs KOLs. involved in We these alopecia as Canada experts. a areata These mean this the Europe in where good experience of well are treating U.S. and is And

So very of a we seeing think education are education know in piece. experts and that available. well. to And we're space. in in good because alopecia network have are dermatology of space going main going obviously medical as who patients there's affairs, I the have have been of important think of are who medical what for probably of is investigators other also are the hair treaters be the very the in nothing there's there's who patients who maybe to We not areata who be of affairs -- aspects I lot treatment that the those the mainstream a

to I going back is know So there's to will and think of treatment bring available let latent population part sort be that of well. to as pool into treatment it going the that be them it

that but the bring it speed medical the be part thing affairs So safety treatment now patients be also dermatologists importance is of does to the a of the it JAK is it, and whole treating work the getting mechanism, there profile on of available. understand to option going really of aware that to

Operator

question with next Vamil comes Our from Securities. Mizuho Divan

Vamil Divan

one landscape Maybe the discussion other there then on up competitive follow and the on to separate question. one

alopecia. Olumiant market maybe much commercial market? I'm going of the what on just JAKs be so same those in for are than this obviously you'd patient in obviously curious, but I'm It's drug already. pricing thinking the there's you're obviously, with and of some the On mechanism how larger side, the other population after curious about terms Olumiant, in targeted

thoughts So some I on your don't know if share you can just of it.

next the sort months just see then what but second few opportunity. are thoughts is going question what to the holds my here, that in ex U.S. of data got your into data. And You the around

how little I how yourself this thinking point of think looking for ex your you thoughts of you data, opportunity a you for about a again, and talked this sort before. just have doing for you partner the guys view it the product U.S. But waiting obviously, bit kind versus about at potentially? share do can are this

Roger Tung

regard a early to data This talk right it's -- yet. now. III very have don't And don't to question. Phase think good does about our to is much Roger. that With discuss us pricing, us I We any for it's it the prospectively. Thanks frankly, it for little

early on range We it's to for alopecia have mid-XXs know in drugs other XX,XXX autoimmune areata maybe really the that and of think that patient point, said [indiscernible] the space with pricing se. at talk to per the probably that in And is per But we the we past based rheumatological for that about here. consistent are diseases. this structure selling in

In terms a at course, this we building not ex an sales ex ourselves interest, of in U.S. do We commercializing see do time U.S., of force. have

and interest some have We discussions ongoing... some

Vamil Divan

reply, Okay. I is think or the a just bit I little my on I you're faint but caught saying. what line guess it else, something

Operator

from Raycroft question next Jefferies. Our comes with Maury

Maurice Raycroft

you tell lock database can with you if III Phase the terms are wondering and out us where closing in Just analysis. of

Jim Cassella

Jim. is this Maury,

and quarter things nicely. So I been think on are that what moving we can for very have is this things data say our track readout

As and to that you to sure our large quarter. can clean and very go ready imagine, Lots we're trial. a into hit we'll make I'm scheduled going is deadline, database of lock. data confident it's reporting be data this to feeling

Maurice Raycroft

Got it.

PTAB just week. next Okay. expected patent be I next And either ask then what And if specifics are provide thinking wanted for how outcome decision any also, of going on on XXX you're steps can to decision. about to the you that

Roger Tung

Well, feel Roger. that very is team, job. good a we this we legal Yes, did oral team arguments Concert's had great like legal Sure.

have probably go of a are decision, forward not that either Appeals. And right clearly, And we decision appeal well a going to the an get intend a positive ability that. or to in XXXXs. we decision, U.S. proceed. hopeful going to director which So very we into legally, are positive we're set well would the so get on the involve appeal on we'll think it we we to that Circuit that positive and decision, think that's If we the how an to we is the we Court that directly if

protection. past, we the strong and patents moving the which the of applications have by think gain that intellectual we'll are XXX additional XXX could move As patent for the we parallel also along with protection provide defense I've to property way, other and mentioned CTP-XXX in forward, in

Operator

Truist question next Securities. Lee Joon from comes Our with

Les Sulewski

is on This Joon. Les for

reimbursement First, do for discussions? any Or you do given you, challenges competitors you they in paved filing. the are that your essentially of slightly foresee way think ahead

Roger Tung

work education we things of date be when payers the to get to is clearly understand it's believe will here. is reimbursement an there that make. an on discussions we've had that the one exploratory to is up payers, be out that think I this rolling indication. a In able initial that medical that have And we autoimmune argument to full that's had something that to have we we'll This But commercialization. with required we'll need ensure successfully clearly, the disease. that's that Well, discussions

Les Sulewski

the should we we And then hiring. head commercialization And expense stage as at kick tapering will off filing? it. into what off model R&D you how Got NDA

Marc Becker

Les, is Marc. this

will be up. But we are as as and III R&D have tapering off. we clinically, So so mean winding tapering down that for be trials this Phase you costs prepare be off. back those commercialization, imagine, those might coming the year I will will

be and The into you remains. OLE 'XX be III so will of down. will cost, Phase right into is continuing winding if will there sort approval, So the 'XX. swishing a themselves trial, actual that then by way, through But the of

Operator

Berenberg. Our Hong Esther Instructions] next [Operator with question comes from

Esther Hong

finish CTP-XXX. Congratulations getting line towards the on for

pushback NDAs So from FDA experienced been few on years a just it there's ago. seems than recently more that

some the on of get maybe account new are as letters, your to NDA? that deficiency this And you're that including of you your there a from pushback, wanted then quick so taking follow-up. And thoughts prepare into I learnings any some

Jim Cassella

Sir, Jim. is this

question. So thanks. Great

I data clinical, thing sets, you is the filing all terms the and need nonclinical think the the in the NDA the package -- of really complete that most CMC. have the make to that the for you important sure

FDA sure expectations it's make plan the from communication you very the an that open think to that met make sides. both have important sure with are I to

FDA. good We with discussions We the to what we had need have know do.

a have database. We safety large

SALT consistently been really trials. that -- XX know We FDA the Phase mean, what we looking have the we've and III, is upon the with everyone for. competitor the the for endpoints I even is have agreed seen across

and sure think the to a make as I are efficacy really safety. our all So obligation have to we is the data really that key for fulfilling sponsor necessary showing

safety a database. have large We very

long-term study. extension have We open-label

X have We that for now. have some on subjects been drug years the over

the that our clinicaltrial.gov including questions we're as filing we some the I listing for and our that boxes, the done, in we've are you'll answering all make that, studies doing all important supportive to studies, the also sure well. of So and like things think best DDI are checking see that for

FDA. really So from with have and we we is a had the FDA meetings that and the making good it a sure good buy-in we've matter have plan, of

will as Of also those have we're on side course, giving the not clinical expected and the we'll we be meetings details, doing because required, pre-NDA the and are but those well. CMC both and

on well. be with we will NDA confirming the as So also FDA the submission piece

So I we're shape, in doing we good what and here. think really know we're

Esther Hong

Great. seeing to what And then any just study. up, extension follow wanted on updates you're in the open-label

Jim Cassella

that, bottom I is had think line we've first roll all, a extension the percentage extension with open-label high into the of study. open-label very over patients the study of

the studies of has of Phase think on over I still open-label We it's that, Phase that roll data or to extension to we've done the fair program. to II the our into meetings throughout have previous for from trend III cuts that patients where date and continued at lot a the say reported is There interest study.

are we've continuation in at again, past. that We've maintenance reported of effect. messages efficacy. take-home of the seen meetings these are think And things the I the really

We concern. or new adverse events haven't any that are any troublesome emerging seen of

open-label think that on is thing. profile So Phase that's the being reported trials, see at of saw in efficacy II we I really I is that think in very the but exposure where we I looked and extension. good this very think with terms surprises from similar and carefully continue and safety are the we a case our to long-term really No

Operator

the Justine remarks. showing closing like I'm questions time. for Koenigsberg conference further to currently I'd to this back And hand no at any

Justine Koenigsberg

for to out. this reach today's morning. concludes questions, follow-up Thanks. Thank to please are everyone call. like hesitate there us If This don't any you. joining We'd thank

Operator

participation. gentlemen, you for and thank Ladies your

have You may a wonderful now disconnect. day. Everyone,

Concert Pharmaceuticals (CNCE) 7 May 222022 Q1 Earnings call transcript