CNCE - Earnings call transcript Q1 2019 | Concert Pharmaceuticals Inc

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Operator

Good morning, and welcome to the Concert Pharmaceuticals First Quarter 2019 Financial Update. My name is Carla, and I will be your conference operator today. [Operator Instructions]. And now I would like to turn the call over to Justine Koenigsberg. Go ahead, please.

Justine Koenigsberg

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

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

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

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

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

Roger Tung

a you, our Thank medicines, at clinical of morning. medical and in year sets with of results multiple very this catalyst for awareness we've number XXXX. undertaken trials which of disease conferences a up rich pipeline us for initiatives. innovative candidates, each clinical made presented we've Already Justine, the progress multiple and proprietary pleased year, good advancing I'm launched have our

II study with to on for by areata. have our our important study date, of positive X to pioneering range work as regimen Let our This leading support of development and profile from track new a CTP-XXX position most internal and, meaningful we as for we're meeting define further program. identified having XXX to done growth patients will our made alopecia tolerability comment We've an our XX a Phase to with favorable date. which move twice continuing me We've advanced impacted for dose These registration clinical dose clinically areata. that daily first results already and on trial treatment Phase very milligrams improvements alopecia drug to The daily milligrams advancements CTP-XXX once finding candidate minimally strategy. end CTP-XXX, for advance provide with provides versus been candidate. forward FDA important observed the potential dose, effective hair statistically believe, include II several

will Importantly, XX II efficacy further Phase fully potential there in the third ongoing quarter XXXX. of our the study, improved conclude with which for is BID in cohort enrolled milligram

In and believe addition, not regimen is we programs the not proceeding. as prohibit decision final patent XXX written specific have committed to of PTAB does to decision our this the work study. dose We outcome of have potential development supporting protecting XXX, track. on assessing other development covering The of claims that in decision arguments it our portfolio. us IPR of time in lines outcome We from remain developing CTP-XXX our our completed that certain intend strong not and does Federal and affect a disappointed continued are the CTP-XXX. PTAB as our reported PTAB issued additional we issuances for month, the obtain favor. The validity remain the the property highly to areata. treatment alopecia intellectual advancement proceeding initial on We're Last a appeal patent in the patient to Circuit and rule did we to tool

impressively schizophrenia as potential appears a second treatment but proprietary our Now toxicity. pipeline. D-serine's to to reduce of form deuterated CTP-XXX, the academic candidate studies of in a D-serine, for multiple for its turning leverages renal efficacy

favorable has, area study. the say, observe about for of move the to pleased in decades, for the treatment SAD seen the II modification the a successfully safety adjunctive particularly with alluded Phase that for I'm if CTP-XXX than we of new this later action. potential need in to schizophrenia historically D-serine. product related safety year deuterium that mechanisms an excited as confidence will much profile we And of completed the our we study, development medical to prospect non-deuterated parameters, profile of safer are substantial We has renal ongoing provided with a been unmet MAD

of have exciting also partner an Avanir, Otsuka we our subsidiary addition, with to program In a Pharmaceuticals.

that improvement to for monotherapy royalties asset, approved, await with Alzheimer's treatment trials two pleased and agitation Phase revenues. endpoint being the fibrosis the first the Phase called Vertex completion cystic trial getting Alzheimer's as a AVP-XXX III with mutation. from the the in for for a doses advancing need payments trial been unmet for XXXX. in associated AVP-XXX, of fibrosis support in AVP-XXX December future including evaluated. of on significant III agitation product treatment potential and believe the For partnered offers Concert Phase patients product see We're results also expected X second potential the sales, on primary initiated, is trial if of cystic this a eagerly with once-daily II X demonstrated we have VX-XXX recently blockbuster statistically U.S. to could with who milestone disease We

XXXX. compound agreement in As asset from a acquired us a under purchase reminder, Vertex an

remains to million million there payment pre-commercial we $XX received, the upfront addition In milestones. $XXX in

believe Board Health. Given Jesper week, high. likelihood the currently this the of of serves announced of these as appointment is Directors. Earlier Mr our and Vertex' development to we efforts, Høiland milestones President Høiland of Radius achieving the we CEO

in Novo at tenure He as Executive is and executive recently held During of expertise President his industry more pharma accomplished Nordisk provide breadth most he with broad the an President will Board. commercial Vice XX-year to U.S.A. multiple roles, Novo our Nordisk, and global than important

which my emphasizing milestones conclude year as by our see Let for optimism our significant XXXX, remarks a of me for we company.

Marc to review pause updated. first our and here Jim progress, our results financial to open like quarter these progress call the to make I'd before and forward towards keeping look we questions. to discuss As milestones, I ask we will then you clinical

James Cassella

both Thanks, With in dosing this an development as of ongoing well areata our clinical time and drug label long-term Roger. CTP-XXX, alopecia as trials exciting of X proprietary for extension we an future II Phase open these for have the study continuation From programs. a perspective, for is patients.

In addition, U.S. II are an additional dose in with Canada. centers we study poised the to regimen start clinical Phase and

the addresses to our II XX and twice-daily have to advancing the into study. robust Also, Interest the is to regimens. our All year treatment milligrams of cohort reach of this reflect with ongoing highest-dose commitment study alopecia started endpoint discuss is trial once-daily for of in patients a milligram efforts milligram contribute our and registration observed severe on open that expect regulators. to of needs third quarter In and findings now X fourth is primary an briefing moderate evaluating in Phase profile label BID CTP-XXX. support enroll parallel, we trial The or a open its evaluate our patients XX-week to BID in package the meeting study completed in dose, we an and these alopecia a our in end last XX II to with of label dose areata the X versus patients II Phase dose is quarter with strong, XXXX. the milligram expected as from with twice-daily which we either our review of dosing receive FDA based initiated planned. to This a in Phase will Data our once-daily March areata pathway. study an developing to extension

pleased the of safety not Phase to weeks. CTP-XXX treatment first beyond who efficacy we're participated to only also in II the understand further the XX cohort, our to long-term offer With patient XX milligram patients studies who and but completed trials

new corporate the efforts quarter, to awareness In medical alopecia This highlighting patient-focused for In community with active support addition we're community intended clinical the the raise resource achievements be disease. to alopecia launched patient areata we section of our and to areata. about a the first patient CTP-XXX, autoimmune website, leaders. is the with this and a

attended the II the session of annual data community. the to presenting month, Additionally, we selected In medical been quietly meeting. early interim American to the Academy we have we March, Dermatology the Late-Breaker actively last the And were during Hair around year present at results at candidate in Phase a to into development, late-stage Barcelona. it lot XXXX. this of intent support trials initiate in Congress results CTP-XXX activity There's Research and this our drug presented is World of for to III Phase advancement

to treatment the of CTP-XXX Turning next for adjunctive schizophrenia.

of standard potential glutamatergic receptor address antipsychotics. cognitive mechanistic and CTP-XXX hypofunction, the negative offers and provides improve patients an thus, therapy well particular, add-on reminder, approach the XXX's unique as symptoms was action both as In to with on schizophrenia. as function positive designed to in a NMDA a As to care

Phase We quarter of we on the data the a Phase Psychopharmacology are II the I trial will to from month, Society Meeting. Annual at of crossover fourth in American this multi-study CTP-XXX a program into of the executing support advancement XXXX. of present I study Phase Clinical Later CTP-XXX

later dose top I We single-ascending quarter. report and Phase dose for data to multiple-ascending this expect line CTP-XXX

clinic we to treatment schizophrenia. to enthusiastic patients CTP-XXX are in potential CTP-XXX our and alopecia product review the excited I'd for to We ask financial paradigm forward new about and the are about and CTP-XXX moving we pause call with then to progress horizon, are questions. Key candidates, will for open with the for to the like readouts schizophrenia, on add for medicine of both as their Marc ahead. results, areata our and here a

Marc Becker

Thank you, Jim.

financial found the I our quarter As press today's first tables financial results, release. reference review please in

was of 'XX of from a a in the with agreement $X CNS In GABAA at Technologies intends quarter the revenue with CTP-XXX, receptor indications. received quarter upfront payment an our Cipla million to which First, to to Cipla million XXXX, first for driven compared modulator, novel develop recognized let's into and $XX.X The agreement revenue. as of spasticity look Pharmaceuticals. other of we with first Cipla and the recognized Processa entered license license XXXX, which revenue treatment QX relates of subtype-selective by agreement

in potential Research the $X.X the sales. milestones we were half Fast the On in an as development million future of existing and In to first to addition, Forward. the of CTP-XXX expenses on advancement product in XXXX support quarter same first The the continued General $XX.X areata the March of the and and increase expenses as and have of of to we well three for XXXX. million. of $X upfront paid payment, the manufacturing CTP-XXX receive unchanged period million and million quarter $X.X associated royalties increase primarily expenses nonprofit $X.X XXXX, agreement, compared to organization a alopecia CTP-XXX development XX, were is schizophrenia. with million for ended an at clinical months for XXXX, the to result administrative upfront

million $XX.X $X.XX compared to million was in is net XXXX both the loss loss of higher to per higher of net $X.XX Processa. or per The XXXX. revenues of a to XXXX or for first in Our result onetime of from the of $X.X the compared quarter spending the XXXX of share quarter increase net XXXX loss share payment first quarter R&D first in and first a quarter due in

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

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

Operator

Stifel. question the comes from Walsh line from of First Adam

Adam Walsh

Roger, would in decision, like what a I ruling the that one XXX is, exclusivity PTAB the of first have periods appeal market follow-ups. of adverse can on patent, you define talked to the for winning not? event the My that couple appeal you versus help following then about the potential And us look

Roger Tung

regulatory another prevail that the studies. that Sure, we X exclusivity, have due Adam, of plus do thanks exclusivity X would of on not believe pediatric for event the to -- in the of likely we question. we appeal, all, Well, first months years

extensions, development Our are patents, years belief the a and patent, patents number exclusivity to, base underpin due I X.X extends XXXX, we the intellectual we which provides there XXX which revenues If of is able CTP-XXX compound. opportunity around sufficient to property are case that get the believe the is which course, are obtain a of additional to you extended compound that outstanding, potential additional to to from that potentially to further filed we've this than referred plus that. of there's that

Adam Walsh

ones quick other of couple a just here. then And helpful. That's

terms your In what's you the long before Phase the disclosed a journal? running? result how data? How What good, fast have idea long get anything see If get like? that to in think you is would publish up what on II of of and And might then take finally, Phase quarter. the CTP-XXX, next? we initial we're those results, do could any do clinical obviously, to how they're there? going intends -- And be II when in they timing you the would Have a that peer-reviewed Avanir second look

Roger Tung

Yes.

taking time that data. the line -- second question staged first. So has a not for of Avenir release indicated

this in are about the eager is that forward completion year Phase are to study and we see of that are of second We it. of the positive that think the We December. everything III very end looking towards to aware

the sorry, Regarding the... --

Nancy Stuart

XXX.

Roger Tung

is this line hope which II haven't about specific the enabling. do We we Phase completion. would for to Phase and be to made study, yes, be it a XXX, end our Phase year, the initiate III intend for time of robust before projections II,

So we'll have that a study. be will significant involved in population that

Adam Walsh

Roger, how of kind there a typical Phase cookie we us general? use? studies are can line in time remind II that Is could long schizophrenia cutter you

James Cassella

Jim. is This

look with XX-week typically those we anywhere XX-week done studies yes, the are the to been -- have schizophrenia population, period. X- with example, for patient at that when So in time D-serine, trials the

a So that of lines we're along have treatment the anticipating period. we'll something about XX-week

II -- trial this so the going a with with into be the Phase afterwards. it going to as support up stand-alone So will III said, to -- power we're thing Phase that Roger

think I can durations. year not so, typically, within So treatment readouts. long But see you these or very to are a expect

Operator

line from Next question is the Hong of Janney. Esther from

Esther Hong

-- questions first so quickly, CTP-XXX. just just on So

and overlap the progressing and XXX? -- this protection second, targeted program out-licensing and later any develop Or CTP-XXX then And with year, the Phase you can CTP-XXX commercialize plans Given to so drug? patent are and updates on internally? discussions indication between study for initiating any the the the provide targeted II quickly for AVP-XXX,

Roger Tung

question, the for Thanks Esther.

distinct overlap carried So really that let's in treatment a not are see, AVP-XXX general negative sense with indication. there's the CTP-XXX high and treatment XXX whereas AVP-XXX a for but some studies amount -- is the a for schizophrenia, directed adjunctive that between being symptoms, is out overlap as of of the are which

discuss of we but of development So completed. on discussing ongoing always anything until in we is process that are the it's business all products, our typically don't

of excited very like program. are feel take underlying the And about sell of thesis XXX. market the We and could we the the product to We one behind it that's, developing and to -- course, ourselves. our

So be have business around of deal. kind pretty development were it if do it, to to positive any a would we

to extremely that and have issued our we We of Now position now think effect property terms in have been reported that let's something see -- the have saw we XXX. an is not we deuterium strong sorry, the ever patent in applications. amelioration of outstanding XXX. around oh protection, do knowledge intellectual do not provides patents yes, right say I modification that terms that, toxicity of on the with that's renal before, to

very have So confident unique development. of compounds, in and a we other the we aspects kind use approach feel deuterated protecting of schizophrenia its its that

Operator

Our Mizuho. next line from Difei of coming the from question Yang is

Difei Yang

schizophrenia? What may for of the positive XXX does for the therapy Does potentially adjunct that just So also on mean? the Follow-up program, clarify the can XXX us couple. symptoms? mean you a side that address

James Cassella

Jim. It's Yes, good Difei. clarify. very This the for is Thanks to question.

drugs are limited of on. because behind are currently is the because not treated issues. be used idea The that inadequately that intolerability is So the these the some currently combination idea treated care with of with standard of of this in patients of or efficacy antipsychotic fully or adjunctive the patients this that the therapy, will drugs

we on XXX drugs, mechanism. and functioning. antipsychotic can study the of that of in shown And symptoms. also in So a negative there's by been improvement effect of that adding shown been cognitive different the it's actually care, we're in terms to add the a the working studies, positive like standard the to of both have symptoms through drug date And top clinical

add add patients So we and top think existing of by the therapy we really going therapy, completeness the up on really can to these our beneficial therapy. effect their add-on of that by for

Difei Yang

CTP-XXX prepared III to positive have development? what apologize mean And And your for it the is does so what's to CTP-XXX, the be step then patent still turning I if missed decision? remarks, XXX I assuming case And the Phase can if invalidated, next what that a after PTAB is program? commercialized PTAB worst

Roger Tung

Difei, the Thanks, for question.

Circuit, of this Court. the that the there of to to whole -- that a step next or one number decisions and part Circuit pattern Federal in believe significant us is appeal the getting that PTAB is at to decision. a reverse leads finding partial decision there our of which or fact So are Federal some we is think a There is reversal complete in the likelihood reasonable a is

very it's that So to continue while our we worth all. think carrying

exclusivity on X-months years exclusivity, five due U.S. years. Europe, regulatory two protection. would avoid the terms additional would XXX that to believe something patent property exclusivity; be the in which ability compound markets. XXX, CTP-XXX additional based to we is prevent of another pediatric potentially and least we only from that not not to able intellectual certainly the likely In of plus the is property it's of it intellectual X protection we but the But are do in to sales a us plus validation to having at on and will seeking prefer And an the years bring commercialize of lack

Operator

to now back turning and Koenigsberg. Justine over the I'm you, Thank call

Justine Koenigsberg

at showing further questions not this We're any Okay. time.

we'll at for Please hope our the thank Conferences, at Thank there. and concludes the be week, for to joining everyone and SunTrust and many participating call. This we this of later Deutsche you we'd us month that UBS note joining us to in the Bank So next the Conference, morning. like you see today.

Operator

This for concludes today's all Thank conference attending. call. you

disconnect. You may now

Concert Pharmaceuticals (CNCE) 5 May 192019 Q1 Earnings call transcript