CNCE - Earnings call transcript Q4 2020 | Concert Pharmaceuticals Inc

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Concert Pharmaceuticals Fourth Quarter 2020 Investor Update 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] And now, I'd like to introduce your host for today's program, Justine Koenigsberg, Senior Vice President, Corporate Communications and Investor Relations. Please go ahead.

Justine Koenigsberg

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

Officer; our me remarks Jim and Development prepared morning Cassella, Marc Roger Chief Joining with President are this CFO. Tung, our our and Becker, CEO;

We Operating portion for Chief Stuart, Officer, be will call. the joined also the Nancy our by of Q&A

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

Roger Tung

Thank no you, Justine. XXXX like other. was a year

generated stayed THRIVE-AAX. patients are to treatment strong trial clinical for navigated through Our business. Based alopecia milestone and on a first multiple successfully company. was clinical focus CTP-XXX best-in-class potentially and last advance in pace the believe for II accomplished our our trials, to enrolling Phase areata. development we the on unprecedented I'm clinical Phase evolution to-date to data for and across of We CTP-XXX moved have that compelling in we throughout III century, executing We've major team maintaining team our our of goals. challenges a what our the late-stage One year, proud XXXX on

it. Designations the and therapy based alopecia breakthrough as severity for treat need CTP-XXX, data, disease the As a on reminder, FDA granted unmet successfully a and areata to of clinical the Fast has Track

committed with of advancing difference are the areata. a We meaningful alopecia make CTP-XXX patients in to to fully lives

XXXX. in with an Our support to the current of FDA CTP-XXX for strategy the filing early development NDA is designed

The Phase expected. as of primary deserves into schizophrenia our month, treatment clinical CTP-XXX proof-of-concept trials what the COVID-XX. the to during study. of team endpoints. CTP-XXX II Earlier trial adjunctive us announced results schizophrenia. of led a of D-serine for not adjunctive field Our an were recognition of successfully did our navigating clinical XXX we hoped we this from treatment not These supporting advance Phase or secondary results for, top-line in or body II evidence Unfortunately, key meet the

treatments trial, obviously have need Our resources will with team in carried executed domains, out outcomes exploring reallocate others schizophrenia across develop and all the the and of are XXX, CTP-XXX. well to of further very to new disappointed but not do opportunities we're intend we'll hope to Individuals new improve with those a results. We that we success. symptom

opportunity in areata described the As market we've sizable represents blockbuster past, potential. a with alopecia

a potential Additionally, developing me business. we where key has to we execution have as with in assessing. truly development to to for what turn year development the led compound in pipeline Jim excited are XXXX business, inflection keeping to our groundbreaking update. you a provide novel progress of we move expect store, that discussion I look clinic With strategy ahead. introduction, a as updated and see his the the has of significant company. well ongoing forward we clinical The in we of late-stage and forward in our number as overall towards candidates as alopecia to are today us that areata, our We're points let

Jim Cassella

patients able to trial. II unprecedented advance This to Currently, as in and with our with completed study began We patients, Thanks, THRIVE-AAX Phase in their CTP-XXX clinical past alopecia were times. first This our the and pipeline CTP-XXX Roger. seeing to Phase sites commentary intended our I momentum CTP-XXX to areata, for reiterate in entire for areata be III as want enrolling November, proof-of-concept our advance Roger's actively Canada continue growing program the we to EU we clinical schizophrenia. the registration. online patients team during expect applauding we well study U.S. efforts in trial soon. there, recruiting coming and support the is are will alopecia sites in where with

which also will design our for that THRIVE-AAX, exception III we study, that similar the trial study. this of THRIVE-AAX, second initiate Phase to to share with to fewer We intend the in first-half patients a intend enroll year,

some initiate overall plan and expected out Data to is support in is to Phase trial from next III plan, year, labeling. XXXX. product round to our and under In first to addition, NDA other projected the support clinical our development and studies early filed be we package NDA the

now Roger CTP-XXX with have As mentioned, we Phase great in opportunity a III development.

the are we believe patient community. existing is a offer impact We CTP-XXX treatment in from very to the potential the we meaningful We new option, the that about excited therapies. have clinically have patients differentiated made progress and and

focused this move of registration. towards closer We as in the year, on the program continued we will execution very THRIVE-AA be alopecia areata

results. open we the to the Marc turn Before the review to over XXXX discussion call me let questions, to financial

Marc Becker

Jim. you, Thank

alopecia deferred expenses due as in were was $XX.X the to $XX.X XXXX. million increase expenses are program increase of As The primarily and to Phase legal to development expenses. toward found in registration XXXX $X.X primarily compared million to XXXX reference I and recognition XXXX. administrative XXXX under expenses financial is decrease for compared Celgene. previous million our attributable were review CTP-XXX $XX.X was for areata. to press fees. XXXX, $XX.X to financial tables million for our The related for development to II General in XXXX CTP-XXX XXXX clinical 'XX, primarily million lower in advance today's we continue agreement R&D expected for Research revenue in with non-cash the our Revenue results, release. please

net or $X.XX XXXX. to million $XX.X for loss share XXXX $X.XX million per net loss $XX.X or Our for share of was per compared a

Finally, we cash equivalents XXXX million in with and ended $XXX cash, investments.

ATM. the proceeds raised During through we million our $XX.X quarter, fourth net of

we result, current expect our plan, fund through to the company operating under cash As a XXXX. our

We We late-stage questions. in pleased are any clinical a progress. have happy prospect we forward having NDA and the filing to look 'XX. our updated our of made early we company and concludes progress the to to with first prepared extremely on remarks, would be our This everyone address become keeping

Operator

Certainly. Jefferies. line [Operator And Maury our Raycroft from question the comes Instructions] from of first

Your question, please.

Kevin Strang

And mentioned noticed study a this running? studies clinical for NDA other your taking interaction expectations what on drug-drug with my Maury. Itraconazole. you're labeling, drug-drug looking for questions. study? was, Are first and And on Hi, studies product other clinicaltrials.gov Kevin we for plan this on interaction starting question is support your you are package. that at Thanks you My there to

Roger Tung

Jim, could you take that?

Jim Cassella

Sure. Yes, good morning. is Jim. This

So, that's right.

package, boxes and interaction of on drug-drug things we we the so NDA the for we when proper will like part guidance can information normal check have that the studies, that submit provide NDA, labeling. all the As we

submission. our we those continue to progress so the development types information with ready the NDA will as that be for we we that in So overall parallel have all doing studies XXX, III program of Phase for will

Kevin Strang

on Arthrex And just in patent whether can are about then front. the affects pipeline? think will March Thanks. Can latest March, talk X. developments about the you one what like case rest the you I be just XXX of it Great. talk on heard ruling a a And the there? patent quick looks your on

Roger Tung

Yes. This is Roger. Thanks question. for the

Court the we this So Supreme depending And, on take courts Arthrex the that rules patent what narrower on have Supreme ramifications. comment either obviously, indicate, can't is in as you upon until -- or the hear is the it. how we could through it, proceeding Court's on broader

we compound a believe its merits. case-by-case that the taken own the situation. situation on its pipeline, a case-by-case rest relate related The differ basis. have. every to tax every XXX any effect patent has As is specifics to don't And far the patents And as other necessarily be on illegal to of on we that

Kevin Strang

back the you, Great. queue. I'll in And Roger. hop Thanks. Thank

Roger Tung

Great.

Operator

you. Thank

the JMP question next Butler Our Jason from comes Securities. of from line

Your question, please.

Jason Butler

for Hi. questions. Thanks the taking

you chain remind terms for activities. the prep doing us on XX-months work supply NDA or manufacturing year next preparations what Just in another commercialization? the be you'll Can one of and over just

Roger Tung

Jim?

Jim Cassella

Jason. No, there's so clinical, done. other need we many things to that that on we focus know because be Hey, but question, sure. Yes, sometimes great

can We sure on, commercial make API have a that, great we things that in I doing those on and track. experience have say to are are going all our registration team, batches, the things front. are a batches, that lot activities appropriate of and that all necessary proper we

Jason Butler

profile. But terms biggest platform it on apart next your some about And factors thinking you're and factors on? when can example, things, impacts pipeline thinking the from For advancements? Great. assets need of just, that the for that, then on prioritization, Roger, have pipeline prioritizing other impacts or the for Okay. clinical obviously, about what you're compounds that the or to, in kind therapeutic looking are have adjacencies the of that to you're example, other focused alopecia the does

Roger Tung

underlying directions. in didn't the unusual modality, that Jason. ability And that there's in aspects as that the next We the differentiation, for our is an of profound on be unusual. about -- different the is Thanks biology to the looking very of that that and thinking But that a which areas on type the Clearly, immunology, adjacency. as hard was therapeutic CTP-XXX necessarily areata, a the of the with are about but CTP-XXX one it we efficacy situation dermatology. next of wouldn't the had in question, really are have inflammation one works we're which Yes. based of had platform those benefits compound. really we of extend autoimmune Unfortunately, number we're And at product far disease, thinking keeping it to that and the point up. out, course, compound alopecia therapeutic of are we as in mind,

Jason Butler

Okay. taking questions. Great. Thanks for

Roger Tung

Absolutely.

Operator

you. Thank

Joon Truist question Lee next Securities. comes line from from Our the

question, please. Your

Leszek Sulewski

on morning. you. actually Thank Joon. is Les Good Yes. for This

go Just in a the second different Phase one beyond you on dose selection. study? you. a possible also to it quick go XX-milligram? Thank that for possible can with is is And it the And III dose me

Jim Cassella

Yes.

Les… So,

Roger Tung

Jim, you to to that? want speak do Yes.

Jim Cassella

Sure. Yes.

optimize, and are dose brought doses II trial. into Phase safety The so the doses, program. first think have X-milligram been and as both in into We've we both those changing the shown that are III. doses efficacious efficacy the the into the is and and for two will build doses to with will for environment, one as for that commercial doses customize around we time, database the patients I selection point Phase done. developing. And that, we the is established able BID of of continuing safety doses we best into those of well to this our going the have is patient. the we potentially doses selection both we our in At doses be not going profile IIIs our Those opportunity are whichever have that physicians both XX-milligram reason III have and be to Phase and Phase second

we'll So and on in these these are the data studying continue we're registration generated, that to we've package. have doses based the our doses

Leszek Sulewski

Thank Great. you.

Operator

question comes of next from Difei line the from Our Mizuho. Yang

Your please. question,

Difei Yang

taking And Good for question. thanks Hi. my morning.

Just of a couple quick ones.

additional The opportunities. first one is around

are beyond for you clarification, same molecular using entities? new for about Or Just you XXX? extension are indication thinking looking

Roger Tung

Thanks Hi, Difei. is for Roger. the This question.

coming answer I mechanism be strong that quarters. areata, exploring alopecia has the its indications both. CTP-XXX due more in in think potential that something to action, other we'll believe is that's the and beyond We of

have we beyond In explored so. out terms ones do to now now to molecular pipeline some had CTP-XXX, to the entities, intend have we pipeline we a resources We extend our beyond for able of clinically. that the and compounds new of be time

Difei Yang

Thank Roger. you,

is question around next opportunities the So ex-U.S.

on So is development late how ex-U.S. you do stage about and XXX? opportunities XXX in think

Roger Tung

U.S. development that Europe think going Well, as are opportunities for term there we the as and in us there. longer be are CTP-XXX to of doing well we in

but U.S. compound As the the on clear we've we're on the outside is the keeping in for made our certainly eye commercialization previously, focus of potential U.S., an

Difei Yan

for questions. my you Thank taking

Roger Tung

Absolutely.

Operator

Berenberg. you. next line [Operator from the Esther Instructions] comes Our of from Thank question Hong

please. question, Your

Esther Hong

morning. Good my taking for Thanks Hi. question.

in activities place? any taking late-stage you. discuss program, forward on prelaunch comment moving you Thank any CTP-XXX Phase with So can III commercial And strategy?

Roger Tung

markets, has very together be several put we're Thanks Esther. which plan. It's for are area. smaller and little Board, who to larger the advisers in it, We're as for as to Hi, working and well experienced in both prelaunch about us both in external commercialization question. closely of premature a a active that members agents, marketing with talking our but

Esther Hong

you. Thank Great.

Roger Tung

Sure.

Operator

for the Justine Thank Koenigsberg, today's you. session program. any This the back to, to program does conclude I'd question-and-answer of remarks. further like hand

Justine Koenigsberg

joining will for Wainwright, presentation section the available everyone, concludes is This And again H.C. virtually and this for these presentations next thank Jonathan. be Conference Details Oppenheimer you, today's Thank conference about our joining. website. us of the you in healthcare thank morning. and you, IR next month. Please at note our be will call,

Operator

ladies Thank in today's This gentlemen, and for you, participation program. conference. does your the conclude

Good may day. disconnect. now You

Concert Pharmaceuticals (CNCE) 28 Feb 212020 Q4 Earnings call transcript