CNCE - Earnings call transcript Q4 2021 | Concert Pharmaceuticals Inc

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen thank you for standing by and welcome to the Concert Pharmaceuticals' Fourth Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to your host Justine Koenigsberg.

You may begin.

Justine Koenigsberg

to fourth welcome update. XXXX and morning Concert quarter Pharmaceuticals' investor Good

me remarks Becker, and prepared morning our Roger Joining with CEO; are this Tung, our CFO. Marc

right brief prepared Development where call Officer. our Operating then Nancy we Our Officer; will by will Q&A be joined our today can of comments we jump Chief Stuart, into be the and the portion Cassella, so Chief Jim

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

Roger Tung

Justine Phase areata thank move to sight the of our is rapidly for quarter everyone first The fourth in and program our in file you joining to with as XXXX half for XXXX. for success our line in assuming NDA us is the update. and CTP-XXX. finish we in intend FDA X alopecia year possible you, as Thank the

X This milestones our readout for year expected for responsiveness well an on quarter. the past challenging team's clinical us look off. we and in with and CTP-XXX data-rich and XXX year the landscape responding back Concert's As plan next to clinical a be the strongly COVID-XX initial paid years. Phase conditions first couple has during on extremely this particularly the positions implementing The executed of changing will in Concert year team focus program, data The of of light achievement the past XXXX shifting ahead.

and expected upcoming our CTP-XXX outline status the program data me Let of readouts.

over enrolled in AAX. We US, THRIVE the pandemic. and lines no and pivotal out it time and Canada, fully X,XXX feat onset the within patients of both our was trials AAX of goals the laid enrolled before the COVID-XX initially small This did we THRIVE have collectively trials These and Europe.

line expect THRIVE year to enroll extension long-term studies trials quarter. and studies We whereby efficacy to All they report expected active second follow topline are this soon eligible in THRIVE THRIVE the receive the third patients thereafter results open-label the from top CTP-XXX AAX treatment. in results to AAX will the The in are quarter. other in AA

will wealth a areata NDA. with million safety We American up are FDA-approved also North to paper, to our of alopecia According a XXXX data be providing data. X.X additional us a has about continue severe open-label there treatments. recent having ongoing in to long-term extension subset been to collect study the US support April since Currently, moderate The there no to sizable could patients disease. with

with of the them players CTP-XXX, long need waited we've therapeutic option. Patients an have the we we and However, profile other in with to-date the important with it's provide potential to opportunity. clinical extent seen and given even blockbuster hope believe a market time patient a

focus the these CTP-XXX. we as clinical the give our commercializing to to late-stage confidence All execution prepare factors strong of opportunity from us and of from our momentum program market development to move

why I emphasize remarks, let conclude about me we're my XXX. As excited

its X a potential areata safety CTP-XXX efficacy trials multiple profile. First, and with supporting alopecia clinical for is compound best-in-class Phase

clinically that the demonstrated large is JAK has areata a alopecia Second, consistent to-date efficacy. meaningful market opportunity for is only the in untapped medical very which space dermatology mechanism inhibition

a be key market. areata alopecia to player expect We the in

for protection we beyond will issued years currently CTP-XXX even believe we IP out. have our for patents Lastly, many

intend We execute. to And ability its year. demonstrated mentioned the data-rich will to consistently same a in as be XXXX. do has it team Our

past We review sufficient trials. our With X CTP-XXX financial both the results. for that clinical will cash let to Phase us data call readouts to who over bring Marc have me turn

Marc Becker

Roger. Thanks,

were and Phase to $XX.X XXXX our related Revenue increase during million financial the clinical reference compared The ongoing million XX, in XXXX. $X.X General development found XXXX results, financial please administrative million the I December increase As $XX.X the was during were related period press in milestones stock-based today's $XX XXXX the was expenses potential expenses Research primarily compared to external ended payment for XXXX under tables in million to XXXX higher compared purchase expenses program. VX-XXX. review year The to for $XX.X and Vertex CTP-XXX XXXX $XX.X same X for primarily the our period million non-cash the cash the during XXXX. compensation. from primarily for service same was XXXX to million to XXXX. XXXX professional to future attributable and of Revenue related during the purchase million asset $XX.X received agreement release.

we loss loss consisted million BVF in XXXX In company a to million the $XX.X per a for under existing fund same compared We and The licensing million common of from ended million XXXX. year based XXXX portion of potential quarter November, and into December in stock expect $X.XX Avanir. investments, future Capital. components: three current and ended on per net of royalties XX, to agreement or plan. of equivalents net our we warrants XXXX raised The our operating $XX.X the Our raise share of and period AVP-XXX RA $XX cash, sale the with preferred cash $X.XX the was with the for $XXX.X or share which fourth

exercise anticipated an would to for warrants, we million company first of the -- of additional would XXXX. in receive beyond which have potential which upon to CTP-XXX the the submission the $XXX NDA fund our We expect of full half the the

updated this be be happy any key upcoming success market. the prepared milestones important Roger we advance forward you us This will the for would to We on progresses. year As gives to company continued to the data-rich drug foundation for a address concludes our mentioned, XXXX look remarks CTP-XXX and year as Concert keeping questions. to and with the

Operator

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

Jason Butler

taking for quality maybe months process, through any seeing Obviously, data, from or process pandemic that as wrapping an without of us just AAX, any issue? the thanks you ahead. experiencing the you're Thanks. with kind are the exciting you going are surprises just Roger, navigating you Hi, can up control – questions. missing few through walk impact or

Roger Tung

much Jason. clinical a the really let one I'll question. Thanks Hi, answer. very That's Jim for that

Jim Cassella

well been you a the quite you? conducting are as it's couple doing been trials during in our How very know, Jason. So pandemic. Hi, years. of We've

we early major I adapted issues seeing We're think any not on. here, Jason.

on Roger readouts for we're track think that previously. I the mentioned

So I good in we're shape. think

Jason Butler

for prep? education more talk you're on side you your And work Great. doing me. the And in Can what planning about terms between the on are? Phase of then launch that potential one the and and commercial III just plans readouts awareness Thanks.

Roger Tung

Sure.

multiple with in at So of we our are and believe into by groups now by that's Board, position also the late We're of would to say us process of going be being the now. time segmentation, NDA a of initiatives targeting position working doing focused. to happening work There's the of our members that done working couple off in I we launch. slipstreaming, process who initiatives looking a quite are of with physician right and competitors. in And we're right a commercially also that's really consulting are bit good

Jason Butler

for Thanks Helpful. Great. taking the questions.

Roger Tung

you. Thank

Operator

Our next comes from Mizuho. Divan with question Vamil

Vamil Divan

Great. thanks for taking the questions.

in was of just the May. a coming quarter saying I couple hoping you of sort terms know up just second data obviously One, date I clinicaltrials.gov So frame says completion just expectations you I here bit. see timing, with a primary could maybe maybe were is little

of we Could sort of opposed of to about data. can And product. in meaningful if second of frame significant being it's sort you more the potentially actual there. in terms a sort there's part this talked any later of you Obviously, what just hoping for of the clinically of quarter you're And then then assume results. sort best-in-class data? statistically terms comment So April? you Just should as

Just guess kind in key I do of you. guess you see sort space? factors the Pfizer to and you're Lilly know you hoping of now your based the differentiating Thank competitors have I to on what where as relative

Roger Tung

Sure.

Jim Cassella

Roger. ahead Go

Roger Tung

on Sure go Jim. –

Jim Cassella

going was Jim. this – hi, is say I to

In we are there. I that is the think that. track on We timing more do right of frame the say and second within terms now best I can't any specific quarter color we comfortable time for could about on the give very feel

field done this publication terms clinically percent on SALT a a achieving of we're in was of that think scalp meaningful patients primary XX less. There results in that using the coverage based having which clinical early that from or or endpoint meaningfulness experts and on relates to I response. XX In is score a more suggested work the represents

corresponds So or that, of to course, less. XX SALT of a score

our primary endpoint. that's So

So achieve a we're would considered clearly to clinically meaningful designed response. be what

So endpoint or less. that's the why score SALT of have the XX of we primary

of SALT our in approximately of see Phase less; eight-milligram or very achieving response score dose BID we criteria, something to milligrams XX So XX% the XX and have best-in-class. XX our terms those using responses from rate for The X we SALT our favorable data a XX% with dosing. close of giving

that's profile data not been other we comparing compared again we just our best-in-class far look at a but the so you when believe So data apples-to-apples reported. have to

Vamil Divan

right. All Okay. much. you Thank very

Operator

Maury from Raycroft comes with next Jefferies. Our question

Maury Raycroft

morning, and on for congrats taking questions. my good Hi, thanks And progress. the

discontinued subjects past Looking number study of back extension XX% the only of about at drop continued patients week your data, but XX. to open-label enrolled

what expect on duration based for many if these And observations wondering therapy know of XXX. a taking kept just how be you you patients on would of these So XXX. your patients typical to

Jim Cassella

difficult in And of cases thanks. When I question. were study observations in the Hey, was the I dropping had data because out centers a in that. It's subjects we lot not open And open-label that think that your great were shortages really one reported were patients became the extension And there's difficult. et of Yeah. were are the a there cetera. Maury think dropping out it complicating factor They during correct. pandemic. staff became heart

I a in profile think seeing patients trials. we're terms staying favorable of open-label very the extension in in general

the from cases three drug XXXX years-plus. X some they've on for the THRIVE, in trial, Our in patients been our work coming Phase

have can't There's move, often. as So other do we've have had continued been to into obviously life drug. where of people people clinic obligations come the lot stay they a that on patients

have think major reasons I some those continued. why So are people not

as seeing lot long for think of staying a drug on enthusiasm we're as possible. I

in. So results open-label good staying I in extension think we're of patients that's why terms seeing in our

Maury Raycroft

Got many patients can you what you're for the And And about helpful. there? study are it. seeing X there? more on talk That's Phase how extension, staying

Jim Cassella

sorry. I'm

of XX% For open-label subjects over into we our X as the -- open-label reported to And subjects the rollover have in extension? Phase from rolling rolling than a we work. XX% we the previously greater high extension. continue very, the For earlier study, extension see we into had very

Maury Raycroft

in just half competition, Got they How as to timelines? the like And half a positioning you to of think both would with intend and the Pfizer it, follow-up relative thinking market that latest that you I of indicating to Pfizer the you're and about question earlier is are on file commentary the entering Lilly the in XXXX. first XXX file from to XXXX and okay. first

Roger Tung

Yes.

the those we entities. actual is remain line both time what approval of see So for of to

As you JAK significant the approval atopic a for delay dermatitis. of in know there was inhibitors

the think inhibition of in FDA JAK data be And the we'll the of in X so, application consistent been entities of terms us the to we're to has across clinical as alopecia have in best that competitors. hopefully of -- use the Phase timelines efficacy, positioned to responds our the we to which see indicated, -- its potentially And We Jim of studies how areata. has hopefully or and have, profile. that terms multiple close

highly competitive. So we we'll be think

Maury Raycroft

Got it.

question just arguments around were Okay. XXX and on patent May oral the the XX. February for is last There That's the helpful. IP. And in expected maybe decision

and outcome Just steps. wondering, if you scenarios thinking about you're about next how can talk

Roger Tung

the of and positive arguments went a fairly a significant a coverage XXXX scenario, active and in outcome. we straightforward for believe error, it outcome of certainly out gives us the us that into think In think, I closes scenario of we legal hopeful we're unless well it's oral which In the scenarios. win terms there that case strong or patent the lose Well, a was win In have Director petition actually, patent. opportunity that to assuming PTE. validity the -- the either/and Court be has address believe to to the think Appeals Circuit plus we she reassessment, had frame for to she's confirmed; for been go scenario, we legal time what arguments would errors, we we to because the would Federal

Maury Raycroft

sense. It makes

you Okay. Thank for questions. my taking

Roger Tung

you. Thank

Operator

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

Esther Hong

taking my morning. Thanks Good questions. for Hi.

So what Phase got data steps of NDA a from question to remain X my trials follow-up. is, both I've prior And positive first then, assuming submission? CTP-XXX,

Jim Cassella

This Hi. Yes. is Jim.

get So, there's as NDA obviously, themselves, comprise from evidence only not a results well but on that once safety Phase the the the as subjects extension X will the to lot major that the those for goes we Obviously, rolling generated into getting trial work study. the X Phase data of open-label filed. efficacy,

We are the still NDA. supporting up other to needed include will some the that wrapping studies into of be

do So, Roger and work I mentioned on between is track think, going filing. as all that. all now earlier, to of And we're on the there that

Esther Hong

Any additional the supporting details on studies?

Jim Cassella

Yes.

a part like Phase of thorough like study. of standard those we are that, requires some X, QT package about -- and something And a just talked so, before

listed there’s labeling durability We've that's that like So also will a ct.gov help that. study. support our we're in that doing studies study

So, as included as those those the well, NDA wrap in studies up be will package.

Esther Hong

my is on then, commercialization. that? anything Any And like second details Thanks. the question on targeting, size physicians the force Okay. sales you're of potential

Roger Tung

Yes.

still we're early assessment the phase. So, commercial in

you in of streams relative for to going the it. additional pre-COVID that a forces We be changes the questions. the bring point on a have down support we'll there of time that's over coming multiple really size Nancy, sales to best terms fine are have certainly years activities think couple that the any get lines. those a of something to to do on the But product the given working of have of color? answers to in nail We and course personnel been that

Nancy Stuart

I think right. that's exactly

we -- assumptions, all activities entering and is making been evidence changing given we now, are sure force and said, assessing we're in landscape, at Roger the COVID would payer of a for I derms are commercial with of number expect. things when forecast other But thought previously think and to the and have we arena really appropriate. mapping the looked would nailing commercial derms just you of MSLs XXX with addition sales or med those about and down how our readiness our KOL as solid the less that

Roger Tung

is just that And a number. about clear to be increased number assessment likely that, it's an than our rather reduced

Nancy Stuart

Correct, correct.

Esther Hong

got it. Right,

looked on any thoughts are the feedback sorry, then from data then, one And what follow-up And KOLs Okay. that just have and to Thanks. that. their just -- CTP-XXX. at with

Roger Tung

Jim, want to do you that? answer

Jim Cassella

Sure.

very enthusiasm of lot We KOLs our that have And There's with lot in as discussions I'd of the that the trials. drug a working a we been enthusiasm beginning. continues with continue from say the KOLs.

Esther Hong

Thank you.

Operator

not showing turn I turn actually like -- back to I'd to do the -- further I'm have questions this to we actually call any Justine. time. at call apologies. And my back the

Justine Koenigsberg

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

Operator

Ladies and does gentlemen, presentation. this today's conclude

You may wonderful a now disconnect have day. and

Concert Pharmaceuticals (CNCE) 3 Mar 222021 Q4 Earnings call transcript