CNCE - Earnings call transcript Q2 2019 | Concert Pharmaceuticals Inc

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Operator

Good morning. My name is Celine, and I will be the conference operator today. At this time, I would like to welcome everyone to the Concert Pharmaceuticals' Second Quarter 2019 Financial Results. [Operator instructions]. I would now like to turn the conference over to your host, Ms.

Koenigsberg. Justine

begin. may You

Justine Koenigsberg

morning, Update. to Good Quarter Pharmaceuticals' XXXX Investor and you. Concert welcome Second Thank

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

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

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

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

would With that, Roger. over now call the I to turn to like

Roger Tung

and good morning. Justine, you, Thank

we for for schizophrenia; half well our we by proprietary key as CTP-XXX for forward to which products, and areata each of events of core two into back for As look clinical including of agitation, Alzheimer's is compounds, XXXX, adjunctive our the treatment CTP-XXX Avanir. alopecia move pipeline developed AVP-XXX as being

study inhibitor we BID treatment treatment the of to stage for approved II analysis and that a data early September, alopecia for next for They of plan from interim top assessing. is the next for advance X-milligram which dose X/X top the the into what which areata. there to were cohorts The set attractive positive. in our our cohort the for final expect our X-milligram results milestone the is in testing areata, best-in-class no a treatment XX-milligram be highly BID III potential currently very is JAK for line the important Phase be are treatment, compound the year. range available finding Phase to for patients. BID candidate autoimmune for privilege the CTP-XXX believe Beginning report has with and CTP-XXX, alopecia disease we drug to dose The We profile appears we

two of We also have BID dose trials ongoing regimen open-label QD assessing versus CTP-XXX. dosing

The QD. It's enrolled, and first to year-end. milligrams are study data expected X milligrams compares XX BID by fully

of BID study intend the out We FDA. expect from to Phase to milligrams of the results read support end next comparing milligrams dialogue to XX XX QD this second year. the from We study with half in our II results first

we legal Federal believe the Circuit take a filed on XX have We the exclusivity. a the strong composition On we arguments In patent process PTAB's patentability of The regulatory we CTP-XXX XXXX matter for the should have on to with months patents. this where scenario two of notice April a about appeal decision protection, challenging years for appeal. would our Court have rely of decision. we front, no final

face to IP and are generic is appeal IPR the keep after this as It's to to exclusivity, approval. competition we important relates earliest pursuing likely patent mind for single the X.X regulatory litigation are actively a proceeds, about other CTP-XXX. With we years in protection

D-serine. compared demonstrated for provided an The schizophrenia. that CTP-XXX CTP-XXX to in modification as form is adjunctive multiple the for treatment confidence has D-serine. us product profile Phase safer a given pipeline. our much deuterium nondeuterated D-serine nondeuterated proprietary potential to developing we are than that candidate our results have I initially that a turning Now deuterated advantages second has of of

pharmacokinetics, been dose testing. show our the Phase included Phase trials significantly tested, renal well-tolerated that exposure reported lower the addition to over the displayed In drug which well-behaved The in D-serine. in was rats MAD in compared a safety be than advantages evaluated D-serine. II trial, a improved profile, ranges and SAD higher doses the for much expected to variability brain safety inter-subject to has In dramatically CTP-XXX saw we I

Importantly, consistent and signs did preclinical of with blood renal any our urine observations, of markers indicate not key function kidney impairment.

our of the month at we discussing and psychiatric to ascending Congress Phase the look data in be Taken therapeutic will with trial and together, investigators of data drug multiple College CTP-XXX. and in explore will community. suggests Neuropsychopharmacology Copenhagen, Phase be in conclusively the dose next I dose to able sufficient evaluate efficacy II forward our our presented European we safety candidate range that a single to

II X, Phase being is their quarter the daily II once to Patients of X CTP-XXX, is to treatment adjunctive CTP-XXX of this existing grams will to trial enrolled in for and X X expected developed doses be year. period. and in to fourth receive antipsychotic Phase The administered begin medications CTP-XXX XX-week over treatment on schizophrenia. CTP-XXX be Our X an we intend will trial randomized for stable doses are placebo. as evaluate a the compared

into to will are that the II CTP-XXX for into III. later and properties, demonstrated to We schizophrenia sufficient Overall, commonly-used dose-ranging PANSS to studies. II advancing favorable endpoint pleased Phase in be scale Phase forward intend primary look be change design this it year. the trial clinical rating The a we total support we to Phase score, advancement

This not are regulatory report the but results to royalties under on expected III October. third sales. There compound. announced an product on enormous and subsidiary Pharmaceuticals, also opportunity, FDA-approved market Let agreement, completed stated me additional partner line now and clinical Alzheimer's Avanir, enrolled, touch has AVP-XXX, of also Phase be a agitation second entitled is trial is that Otsuka milestones, and are worldwide treatments fully agitation. AVP-XXX Otsuka no candidate, is in this future the of commercial top year. for the in which structure for our the is to expect we Alzheimer's to they the only

Concert's our financial to quarter on me results by readouts for Let pause the optimism for our here before Marc to we enthusiasm review and data ask like continued horizon. the I'd questions. open call and conclude second my our to remarks the pipeline emphasizing

Marc Becker

Thank you, Roger.

financial As our and Revenue second today's second license I quarter $X.X of reference the found results, XXXX, a result Cipla tables in please modest quarter was with totaling first release. million press the Technologies. review of financial agreement a in as

of relevant compared $X.X we to million development Research who In million. and the and in licensed of a research increased expenses indications. to in for XXXX, and ongoing primarily XXXX of the quarter Cipla, expenses were as the CNS spasticity the to $XX.X develop ongoing development of to first with quarter second as the compound, in development. novel well quarter development The of clinical to XXXX, an related associated clinical intends including support $X.X other multiple CTP-XXX, increase of trials CTP-XXX, CTP-XXX manufacturing million expenses increase it second clinical

expenses is in administrative $X.X in million XXXX. second were of to attributable legal and The compared XXXX decrease General $X and quarter to the same $XXX,XXX of employee-related the for decreases period million for expenses.

was The in the to in result a compared of a Our is for to net share the second the second or of XXXX. spending XXXX increase per loss million higher loss of quarter XXXX of second per share compared million or $X.XX XXXX. net quarter R&D quarter $XX.X net the $X.XX $XX.X in quarter second loss of of

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

position current through first $XX plan, cash which be sufficient happy we of our including prepared As operating III quarter. half company development in to of CTP-XXX we questions. into received to This burn our of we is be believe move would fund million, remarks XXXX, approximately address we any in escrow XXXX. Under is expect the the proceeds cash into to Phase next our the $XX our planned net and Vertex second year, the advancement concludes million from

Operator

instructions]. [Operator

from of SunTrust. comes Our from line first the question Lee Joon

line open. Your is

Joon Lee

congrats all And the progress. on

XXX, schizophrenia understand potentially upcoming and be positive it's going it therapy, seems adjunctive negative be Regarding to symptom your you'll an potentially using opportunity the I for And bigger. scale. making much study

appropriate some the the be deuterated drug drugs. you arguments in deuterated may, the if dose the the the enroll able on made know disclose to these that I with define some scale know X of what, already And based were findings failed D-serine, and X certain XXX? what inclusion second of And stable non-responders grams antipsychotics? improvement curious for Given similar properties with would of guys appeal have unique number that situations those able be unexpected you supports experience the are Would is or novelty I to have prevailed question, would you criteria? a X, be on on of who are of what past using I you expected an any, antipsychotic, your would patients the if of XXX? ruxolitinib. to under in

Roger Tung

podium the the take very Joon second to first, then part of give of take Lee, for that thanks part the Jim the and over it. first much to I'll question. I'll

Regarding the the structure part, we've PTAB. briefs before out second for argument -- in our our laid the

very difference, greater So qualitatively, arguments briefs the We comment already that CTP-XXX to quantitatively should general think be this Jim, the making. since we'll do making detail good between that types we those those question? point, be probably really clinical think Federal at only public. of finely is It's you will are prevail. are those take why to for the arguments And inappropriate our our not generally of the and have there in arguments we a in but more but could structure Circuit, we reason ruxolitinib. that

Jim Cassella

It's Joon, great thanks for the question. question. a

we of have So when that antipsychotics, -- as the world. symptoms at look And know, for adequately been schizophrenia. not they're used antipsychotics in do the have know now. we And decades schizophrenia, around used there all treat they the all you been atypical

have but positive you have strong you and is still the So symptoms, with effect well symptoms symptoms as generally, very positive negative mostly leftover, cognitive what functioning as the residual a symptoms. on

symptoms. think world generally as a in whole I of that all patient So are the treating population the underserved around the

mechanism addresses So well that on positive with a and at shown our D-serine, on using trials XXX is like know form compound of approach we that symptoms a as cognitive deuterated have effects clinical functioning. as a and adjunctive negative looking the therapy

So of symptom improving help on in where domain. we a the I think we can the benefit position patient the stand overall by

that's So taking. we're approach really the I think

identify way symptoms the improvement be identifying with have use the in PANSS been that has to we'll scores, the of then the can to able the been a D-serine PANSS scale is around trials PANSS their patients patients, the with measuring still This use terms widely done that remaining compound. that as that In have and literature. a We like our of by used world. reported these

basis have profile. symptom think the a I on there benefit that for we show very good can believing So we

Operator

comes line Our next from the question Stifel. from Adam Walsh of

Edwin Zhang

Zhang on Edwin is This Adam. for

quick A twice daily quarter. congrats progress all last First, daily on XX-milligram open-label know and on the CTP-XXX. trial going to -- We open is an XX-milligram question test made you it trial. once in

XX-milligram part my Phase trial with early of be in to next discussion this end of the the So the not understanding, year. FDA II will meeting

there the this? are support to this factors doing what So drive trial? any PK/PD data you that consider Are

Jim Cassella

Jim. is This

trial we the have that the QD XX-milligram QD. is So the doses. the this trial open-label ongoing and which versus BID BID you mentioned X-milligram trial, -- an currently XX-milligram XX-milligram an looking with second the open-label is is at And And ongoing.

If be that meeting these that trial of the the of completed When is and was an part help we were with our United is into versus intent dosing. data we once-a-day BID, footprint trial trial have conducted we But versus point our us FDA. end fully more It trial our understanding So able looking States, that time, open-label twice-a-day II of trial. and The in to that able to XX-milligram once-a-day dosing. that the of by outside the incorporate also was in trials. are is to Canada. twice-a-day not open-label will of the being XX-milligram expand understand the Phase QD

patients. So we're to able our engage expand investigators, to Canadian profile now Canadian

so also another And well. purpose that's as of trial the

our have trial at from very our us but the incorporate. trial Phase we that dose many meeting, completed, of we'll useful for in So the use we ways, to can will data have first II time data end and be whatever able this regimen we'll be

Roger Tung

enables our advance it compound patient This in Right. the is the overall total dose dose. that and to get will for to our I'd as greater Roger. profile XX-milligram the also inform XX-milligram to do to with FDA. of well of help and total That what is like tolerability understanding safety of discussions add in exposures the as us efficacy

Operator

question comes from Our from of next Carter the line Gould UBS.

Carter Gould

sort briefly, You talk made back Roger, you guys good just take if competing maybe of across point, compare guess, point? could just forward. alopecia? up kind see I how you a all and how clear the competitive of maybe at a progress emerging you and of really at have stand you this you think step kind stack and path have where and the step back you and But this approaches environment

Roger Tung

question. for Thanks question, a it's think the Carter. great Yes, I

know, was that treatment As inhibitors and general, areata. some there released you in of was data by alopecia of that speaks in JAK positive effects recently, ability have the alopecia Aclaris new in to, to

I the of that think far, with have terms of in CTP-XXX, we're level efficacy so seeing we

been to as test have we released what see the has to at date we dose. equivalent yet data and least our to best that highest

profile, good has potential in that continue XXX our the has been and reported safety. agent a tolerability or very the we believe to be trials with So to reported tolerability what best-in-class doses,

is of studies there of that access to not treatments. approved community and a level has patient think that successful So a high potential well treatment for had I

CTP-XXX first, to think one treatment. the be of least, I treatments the at best-in-class and patients opportunity to potentially has the available

we're to the this we XXX. seeing we see So how like that very forward look out. we enthusiastic with have. But what plays And about we profile

Justine Koenigsberg

Operator, we can the next to move question.

Operator

from Janney. from of comes Hong the Esther question next Our line

Esther Hong

Thank on used feedback of discuss percent are takes not any if lastly, there atypical CTP-XXX patient antipsychotics what be can had the any the those on CTP-XXX, atypical with then you population if you've an discussions community And where treatment? medical adjunctive So And or would antipsychotics? so, you. CTP-XXX? as

Jim Cassella

Sure. Esther, Jim. is this

with to will use we not -- literature, the use is we on based only that seems the literature, with not -- drug clozapine. that XXX in will So

top been patients. handful that work but basically actions many added of only has, data its in So when Basically, is It's a atypical. might of like on of there clozapine It's with the it's a clozapine is percentage therapy, line positive an it a D-serine much D-cycloserine third belief clozapine. hasn't small that a patients. used drugs very through or percentage of

XX take think comes So top we've that not It's we for like only been dopaminergic at add has looking which hypothesis. on really community the with the last that spoken the mechanism It could drug the shot been your medical out about mechanism a to different D-serine. antipsychotics the very would at a on I enthusiastic can putting I really used of a NMDA that drug that's our question, hypofunction have XX, be next years. is that of.

the being a is is think that patients this different hypofunction data of D-serine mechanism, low relevant viable with levels I have and one a that suggests that in NMDA reflected very mechanism. by literature other

have I date studies been think the in worked while encouraging. generated with that there's some haven't been studies out, studies been data the that's academic D-serine have clinical have the very -- to positive been been that

excited lot in I this worked are program. So very there the think before. with trialists I've be to space get that of we I schizophrenia is and lot A of -- a KOLs the clinical excitement. the speak in involved

Operator

instructions]. [Operator

Capital. Our Garner from of LifeSci comes the from next question Robin line

open. Your line is

Robin Kalley

ask CTP-XXX. I to question regarding wanted a

PANSS endpoint. to mentioned a to important Can You the to expenses forward. regarding the another question primary And endpoints patients as secondly, speak you that secondary would your any FDA? score going and be

So the lower QX year? R&D rest R&D the QX. expense of expense we in think was about should How for the that than in

Roger Tung

I'll then let the take and second. Marc the part question, I'll first the of So take

at PANSS the total So scale benefit. a the for is great looking

it So as that's used why will the endpoint. primary primary a -- be

will Impressions. Another very important Clinical a endpoint be Global

as trial. I Global can on a well you Impressions think Clinical the using in rely Scale So us

look there and are there's the also that's total at you look symptoms It's symptoms, positive when at of the the with subscales. you the subscales when analysis primarily, total reflected symptomatology PANSS. And PANSS, score, X negative things on at look other the PANSS of One associated general you psychopathology. traditional by to and PANSS, consider on the

things be at can you as So measures, as well. exploratory at that those looking be assured we'll least

Marc Becker

Marc. is This

reflect R&D is have. just few quarter, the our CTP-XXX yes, trials think quarter, our that. in burn quarter to And before question, million R&D guidance was going be R&D CTP-XXX upstart $XX expense to the advancement clinical and for around the the in cash $XX we of QX, gave the I of On year. We expense ongoing million last then the this that

which overall, -- at to expect our we're a tightening additional as last announced some as and guidance, little the our So our I well reflecting that that going is own in just cash and of lower manufacturing come guidance, than efficiencies. that we time, that's assumptions

Justine Koenigsberg

I question. think take we can our final

Operator

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

Difei Yang

a Just couple.

despite us first drastically having on the higher remind has the effects why renal Would improved? been The you hypothesis, is one CTP-XXX. exposure, side

Roger Tung

very mechanism fully of of much for thanks say Well, toxicity action got the of the I've to not Difei, question. that understood. is D-serine the

answer. give detailed kidney We So as dysfunction is a do substantial in there in a very we the exams. see can't that actually of both change, histological as well markers

is this Clearly, well-understood of that frankly, terms versus toxicity the be occurs. effect. and quite playing CTP-XXX differentiated we why the There in hypotheses of that of impressive, a toxicity. a unprecedented is are So are This profile may number for into a phenomenon. very and D-serine, in difference metabolic

I'm sure, So the we future. will detail looking in into in more be it,

Difei Yang

question you additional Would for or calculation share be thinking X.X IP, your asset on Roger, will CTP-XXX. any is with us behind, your the that then even years? final protected the without

Roger Tung

Sure.

This also other is more And new that that component XXX entitled both a it for five regulatory NCE, we pediatric a we've chemical that to exclusivity. is So FDA. of it. with around that the based are a is basis with has on confident highly an and deuterated had specifically entity, years to as discussions that analysis CTP-XXX disease is compounds

compound compound or that processing for based before expected we on time for six would The at of the roughly just So the least current an would that And analysis precedent. entitle could year, pediatric that's community, be us in we study additional of studies the required the a be to an do that of guess, months exclusivity. are as filed. ANDA would

conservatively current So based data, on that would we be, feel years. X.X

Difei Yang

you, look readout for XX-mg clarification. in Thank the forward September. the much Roger, for And very CTP-XXX,

Roger Tung

Thank you.

the As Appreciate we. do question.

Operator

time. further the to turn I no over at this questions now are call Ms. There will back

Justine Koenigsberg.

Justine Koenigsberg

Wainwright I would many and concludes us participating conference see morning. to hope month call. there. next Thank this that for conferences early joining to the you. thank in of Great. be everyone you. you Janney We note October. Please we'll the and H.C. Cantor Thank like today's at This

Operator

teleconference. today's concludes This

You may now disconnect.

Concert Pharmaceuticals (CNCE) 4 Aug 192019 Q2 Earnings call transcript