CNCE - Earnings call transcript Q4 2018 | Concert Pharmaceuticals Inc

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Operator

Good morning, ladies and gentlemen, and welcome to the Concert Pharmaceuticals Fourth Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Ms.

Koenigsberg. Justine begin. may you Ma'am

Justine Koenigsberg

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

Our press press release this announcing at our financial results an available our copy concertpharma.com. also morning, was electronic of is our release on website and issued earlier

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

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

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

Roger Tung

you, milestones Thank proprietary to morning. and a be that quarter the meaningful XXXX progress year pipeline for the to relating set stage our achieved we of Justine of XXXX, Concert. fourth clinical good several In for

highlight The activities. already Jim then development results. review will X me CTP-XXX, which for potential areata. alopecia ongoing several is Phase advanced CTP-XXX produced let our First, candidate important trial a the most for progressing nicely very treatment as ongoing our has details

statistically, meaningful effective twice-daily have that with is minimally and results. X believe, providing we first we The clinically dose a milligrams identified

and a important on areata. FDA issue, clear as they alopecia in has accomplish outcomes balance it long-term We focused are this we regulatory safety with and inhibitors believe the of the the patient JAK are very treatment that between made is optimizing to group first

the good we larger also to-date Second, and well-tolerated, believe study efficacy. no We be group, a efficacy of if X greater believe curve dosing produce XX-week observed may while dose even in to endpoint appeared the with CTP-XXX BID could observed we plateauing. upwards that was results weeks that And commercially dose. for studies, milligrams beyond milligram indication are X it that, viable XX be generally response showed found the trending

addition, there In BID for milligram efficacy fully cohort. XX improved is potential our with further enrolled ongoing

Finally, once-daily XX label for are open versus greater on convenience dosing twice-daily X potential assessing the patient trial. based milligram once-daily our in milligram we planned

with potential Our believe optimize we we X a perspective is that efficacious results strong further regimen we as upside the on efficacy to have and development. to-date, for CTP-XXX dosing generated Phase dose an the Based approach the the our very is from there towards program move about ongoing CTP-XXX to forward testing. of an CTP-XXX development opportunity Phase and enthusiastic pivotal into commercialization. we We're as X Phase directly and trial X accelerate move

now with as turn by initially the and with patients proprietary potential in preclinical human in the well second to maximize important mechanism believed schizophrenia, positive schizophrenia schizophrenia. offers me which X preparation renal We to NMDA have are to different to D-serine, a available schizophrenia. been mechanism's our the evaluate treatments. us about concerns patients symptoms, We currently advancing in an the is it study this year program compound's from and candidate in significant both let believe first-in-human factor will year. safety efficacy the as patients. momentum to program build the Next, data action utility. evaluation Based for D-serine that treatment on of its an XXXX function as our will We're in safety and developing in CTP-XXX that non-deuterated X schizophrenia into be has clinical CTP-XXX, therapeutic in a may from as XXXX developed importantly, associated that This clinical improve rapidly Phase is cognitive avoid the renal be CTP-XXX non-deuterated designed groups excited negative with positive later very D-serine. an on and it with academic it which this hypofunction, bring development to study adjunctive can remediate help Phase and clinical observations we we for in advanced widely pipeline we're CTP-XXX enable that to characteristics

of alopecia In subsidiary areata schizophrenia, AVP-XXX, about prospects addition with developed the Avanir, our and is collaboration CTP-XXX in we're of also under in to which Otsuka. CTP-XXX a excited being

AVP-XXX along X these the first the that study Otsuka Alzheimer's XXXX. in AVP-XXX with around in results reported expected on eagerly expected agitation agitation for of royalties believe need the support and XXXX blockbuster is milestone results is from right we Phase type Alzheimer's thereafter. sales medical treatment We Concert, for associated line unmet as expected of the reiterated in completion completion recently December The to pivotal April await readout future for top potential initial sales. results with be offers and promptly to US approved, Phase with X dementia with could AVP-XXX product the the if payments second trial corner

expected and of validity render on January patent believe comment of arguments and proceedings clinical me Before a progress, details against the CTP-XXX to CTP-XXX, strongly that decision to we with in XXth we important XXXX. In IPR Incyte front. the differentiated have patents to turn by Xth were oral a the brought legal make our We final properties the respect of brief other covering on let our held the April PTAB is about a ruxolitinib.

ways An specific would believe outcome from aggressively to for the alopecia the to patent, and be its not development regardless protect development proceeding. would proceeding multiple developing the concert of outcome areata we CTP-XXX for continue advance to CTP-XXX this prohibit we have and of legal that timelines in Beyond IPR intend adverse CTP-XXX unaffected.

review see team the our saying XXXX like for Jim fourth our our and at discuss a that to pause milestones before by focused I'd financial Company. as open Concert significant Marc remarks to year of we results, we're my is call then quarter clinical progress questions. here progress conclude on the continuing will making, and ask to very me Let clinical the we and

Jim Cassella

Roger As well so that in we foundation, XXXX, to the laid in just of on candidate lead are we advancement our XXXX positioned and described, clinical CTP-XXX. execute the CTP-XXX

the examine we is with evaluation and with X-milligram in X-milligram a a CTP-XXX. are amendment trial me clinical we from currently And begin alopecia the we CTP-XXX two results as patients in September. areata. in of the X The Let In the reported included ongoing, analysis protocol interim November, XX-milligram assessing of doses first dosing twice-daily interim dose that added cohorts. twice-daily Phase

endpoint of the cohorts. hair endpoint the In XX compared Notably, X-milligram in the and well serious did XX. percentage with X-milligram with cohorts, appear X-milligram trended analysis the higher with first weeks statistical not the CTP-XXX adverse primary met X-milligram at significance the our was the course to we two terms both and cohort, week of generally regrowth primary in BID BID over reported of of plateau of the treatment, to tolerated twice-daily placebo and patients dose of the dose. the X-milligram achieving events no

BID CTP-XXX We for X-milligram are for efficacy these highly tolerability encouraged by data dose. the initial and

findings to us the Dermatology's this late-breaking presented response clinical American presentation areata. In to-date clinical results will plan for confidence as Meeting development CTP-XXX. mechanism at observed be we continue fact, weekend. Annual at of we trial, continue support action Academy of CTP-XXX's have in these strongly gives a These our The for the alopecia great

quarter with including we is important clinical label and complete. trials, the XXXX. the XX-milligram in primary these be dose and data open assessing in the milestones end and frequency steps data dose will next findings compared additional trial, and select patients complete of based to half this data the moderate third CTP-XXX now XXXX. quarter Phase expected pathway. new cohort the second the the to intend enrolling CTP-XXX an in expected with once-daily trial, investigating final discuss announced the ranging help in to to study doses we on initiated the the X the endpoint enrollment begin X we to us is line to cohort first and with we fall, information X-milligram to BID describe XXXX. meeting Phase recently dosing trial me dosing, give review its X-milligrams This we severe is registration expect patients of cohort Phase trial program. evaluation. Once pivotal XX-milligrams from BID in CTP-XXX of we is our the X FDA the observed that In in Let for areata, alopecia X twice-daily. Last This Top XX-week which will Phase a reach an The clinical for parallel, robust in XX-milligram of trial

open in who an who we X extension offer our forward, Going cohort trial. ongoing the completed XX-milligram label Phase and for intend patients trials, those to including enroll

We to it CTP-XXX as product patients a focused areata an meet treatment possible. and need this and to areata develop safety the are alopecia to highly with effective favorable on alopecia taking for are for quickly steps profile bring profile with as

showed CTP-XXX the adjunctive and CTP-XXX, comparison, pharmacokinetics food We and drug. X of treatment doses of to program The for evaluation the crossover of study increased in volunteers single crossover D-serine CTP-XXX initiated the the program compared next exposure that our includes analog schizophrenia. CTP-XXX as plasma Phase Turning December. has to healthy as a of of in well The of D-serine the multiple ascending the deuterium-modified Phase X on effects D-serine.

and in no addition, was were In adverse volunteers, CTP-XXX tolerated events healthy reported. well serious

Phase in multi-study support pivotal XXXX intended a our is the designed fourth X move that of quarter Phase have our components We next trial X program support in to advancement of evaluation. into to to the ability

report the of expect first additional half data line We to X in XXXX. top Phase

program in biology, standard as and fill is symptoms, need, patients schizophrenia standard function We carefully CTP-XXX's with to offers to in that input negative leaders CTP-XXX add-on glutamatergic a as including for and provides NMDA address the approach to been includes well particular potential with an gap potential unmet are designed as dopamine-modulating medicines. therapy CTP-XXX potential in patients was believe Our of well. current treated an who antipsychotics. NMDA care the from care positive has receptor CTP-XXX the primarily cognitive the inadequately hypofunction offers address clinical today. of progressing on the designed a unique the the thought schizophrenia schizophrenia. CTP-XXX has antipsychotic for both and to and In action important to in improve, mechanism

mental significant about product like address progress. I'd of to these here enthusiastic the of unmet the CTP-XXX proprietary FDA no candidates treatment about the has and candidate for with both moving CTP-XXX, for Marc upon In this millions summary, improve patients updated currently ask clinic look that we approved keeping schizophrenia. horizon forward drug treatments, CTP-XXX CTP-XXX questions. proprietary to improve we are of open our excited existing we that with of to alopecia have and for pioneering results, of of many In We potential in And forward opportunity treatment review medicine alopecia debilitating the before can in patients. our and needs the disease on as mechanism a these case to adjunctive schizophrenia our you are we areata Key with of financial new standard pause a advancing care we readouts for we areata. potential Both the to believe are illness. action call a outcomes on into for candidates to the new schizophrenia. for the are in are CTP-XXX,

Marc Becker

Thank you, Jim.

Processa million $XX.X purchase whereby to commercialize known I Pharmaceuticals under revenue a to rights December In was CTP-XXX. agreement today's in Revenue granted ended agreement XXst, as release. XXst, XXXX, of licensing non-cash million tables results, whereby in relates in year to for develop $XX.X XXXX. acquired year financial consists VX-XXX. and recognized compared Vertex Revenue ended please $XXX.X XXXX the received found financial worldwide review we asset XXXX million consideration the our now the for press As Pharmaceuticals XXXX, CTP-XXX, reference the December

into in agreement, Relating the CTP-XXX. released Vertex expected. rights worldwide escrow cash million commercialization Concert the was the $XXX XXXX of paid that payment to development and upfront of Concert to As agreement, the part for put million all in as was $XX Vertex QX to

an to of from in CNS agreement XXXX, under in General million Cipla milestones, of increase results associated half non-profit receive development compared into the of CTP-XXX treatment based and will a $XX on as first increase and we have modulator. for to $XX.X the Forward, increase product and as XXXX milestone with expenses relating license pre-commercial future agreement. expenses the $X.X subtype-selective on CTP-XXX. Fast clinical also with in the XXXX modest in GABAA XXXX, sales. initial We milestones between Forward quarter to of Concert organization Cipla Fast the to received $X were and make and agreement. million. Cipla entered development other payments compound both to agreement owe on an expenses indications. milestones We $XX Under spasticity and is Concert's evaluation the are to Fast administrative million preclinical In of and million $XX.X million. XXXX, the million of clinical relevant to were and for to The to existing primarily we achievement with CTP-XXX, of novel compared upfront upfront a receive building CTP-XXX million Research intends Technologies receptor CTP-XXX under have manufacturing Forward future $XX.X million an develop royalties well $XX.X the potential and obligated of Cipla the potential

share Our XXXX, loss to Vertex. compared purchase due income asset $X.XX to million $X.XX million agreement per was in net $XX of with net per share, $XX.X or the or

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

our and As half acceleration proceeds including in be under of we we our current development, we cash our the the is cash of net happy to remarks escrow any move from plan, the we This our And which expect Company of would operating fund into through XXXX. is to concludes sufficient CTP-XXX Vertex. approximately $XX the be $XX million into believe million, XXXX, prepared questions. answer late-stage second position to burn

Operator

comes And Carter your Instructions] [Operator first from question with Gould UBS.

Carter Gould

the Roger, into do taking wanted Good morning, and to the going work little optimization of bit to to for dig just Thanks questions. sort I there. guys. you're CTP-XXX a

dose? follow need sort move trying get just how of Just how to a pivotal that of you to understand access long kind data a and a trying And stage-gate patients of the optimize understand additional to you to what think that to study? need you maybe then really sort into

Roger Tung

for the Thanks Sure. Carter. question,

that, was effective that have the to We and think believe at identified we that but we point, this not saw as X-milligrams which statistically – twice-daily. twice-daily know, we placebo, is dose, So, superior numerically, you minimally X-milligrams a that's forward which is program – that XX-milligram The we to is understanding. this with XX-milligram the highest can and of enrolled aspect pursue. now move which ongoing that fully we that important dose now very dose, is dose, intend twice-daily

the dosing, In and longer-term to patients dosing. XX-milligrams our shortly, into who is intent both terms of the over XX-milligram longer-term are receiving once-daily twice-daily extended versus is begin roll X-milligram which a cohort, to twice-daily planned

us with our give information apply So in that that patients, enrolled are should should individuals, who longer-term and subsequent studies. to those

Carter Gould

or that terms doses might X it CTP-XXX, well? duration any Okay. forward you endpoints of early, of provide maybe in on And in color then plan of the little bit study with, but as maybe either of too number move a potentially planned can you Phase on to terms be

Roger Tung

the the studies doing the the what Yeah, XX-week results waiting duration doses. ascending to schizophrenia have of really thinking point, in would planned to dose-ranging in we X. the of intend intend doses dose to multiple we of that's time But at over to in of frame for the Phase about the XX-week We're typically that this drug nail we do. efficacy study study, assess probably been to down are the and terms the several the at look study

Carter Gould

Thank you.

Operator

from comes Difei with Your Mizuho. next Yang question

Alex Lim

Thank question. morning guys. taking Difei. Alex for you on is the This Hey, good for

endpoints the on a what about Could in are follow-up there at CTP-XXX. bit of little X be looking key you Phase some the had Just trial? you'll talk a

Jim Cassella

Jim. is this Hi, Sure.

score So we're is positive parses think scale. we the in I the so in you phase this think it that experts see you scale, important I at at negative the the meaningful at are data still the point clear and of And PANSS of also of results for to scale can in D-serine, time, in overall existing looking positive symptoms. looking and at schizophrenia and look designing this be as negative talking one endpoints terms when a But lot the out we'll that pretty and symptoms space.

that's to key be So the think of that using. one be going we'll I scales

Alex Lim

on what Okay, great. pivotal wondering Thank gives you than you. able And just you be may into move CTP-XXX, just confidence that planned? trials quicker to originally

Roger Tung

of high statistical I Phase fact that study pleased of Well, X-milligram got twice-daily out data of Right. that initial we level very cohorts. the with a we the think certainly was the versus quality significance reassuring. dose cohort versus in results the saw X The such are X-milligrams placebo X-milligrams at we

high the the We appear are be of plateaued fact to we observed increase the has well-suited to-date that XX-week that impressed all dosing given the have not confidence that be continuing appears this at a and for to efficacy frame, time medication disease. the appears have longer-term us does level to and by the with to drug we at of what tolerability least have

Alex Lim

thank Great, you.

Operator

your [Operator Stifel. with Walsh question Instructions] next comes Adam from And

Adam Walsh

guys, for taking Hey morning. questions. my Thanks good

be be outcome of because so to press the just Concert? Thank help looking the to little there you. structure for what would us AVP-XXX So, could background of you're in April. us coming coming Roger, And maybe and positive products, that but top and pivotal you've past of release, I bit the color remind in some us looking trial for bit and of data the what for how us helpful. we're the per there just a restricted terms you have April could you and data on line understand help know data been kind Phase of in for little a X the of meaningful in understand, deal That a partnered remind just design,

Roger Tung

for the Sure. Adam. question, Thanks

that about So they to I that's aggression parallel-arm important that's sense from a based investment is on for in and in sales given milestones basis. estimated for agitation maybe there AVP-XXX digit of with which the of really with Otsuka trial Avanir, million and the in commercial trial digit detailed we looking Company, you're be agitation think some could trial. the would versus of potentially not medical the is about that to an – the and of a mid-single first-in-class in It dementia disease intent really a AVP-XXX worldwide are are treatment doses the royalties to Alzheimer's recognized just We reduction information have the low-double recognized potential the rate by community very be this symptoms X.X aspect disease. patients the that is fact approximately best with a Alzheimer's symptoms, benefit on fully that both design, of from that And assess be of country-by-country disease several it's that the a in the being that's a agitation, because with US labeled to use. in XX% significant important a owners placebo truly for contacting and at perspective individuals believe secondary

that, could Company. an structure overall I reduction on a think capital symptomology in our that assessment have this So extremely positive statistically tolerability acceptable as there effect is is significant if with our

Adam Walsh

you. helpful. That's Thank

Roger Tung

Sure.

Operator

closing no showing I conference questions remarks. am Justine turn this back I Koenigsberg for will to now at further time. the

Justine Koenigsberg

everyone Thank this in you. for thank listening to like I morning. would

to participating many be see you. you New Oppenheimer concludes will today's and York of Conference the there. at call. we month, Thank This hope Next in

Operator

Thank Ladies day. your concludes a have conference. and for today's and participation wonderful gentlemen, this you

You disconnect. may all

Concert Pharmaceuticals (CNCE) 1 Mar 192018 Q4 Earnings call transcript