CARA - Earnings call transcript Q1 2018

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Operator

Good afternoon and welcome to Cara Therapeutics' First Quarter 2018 Financial Results and Update Conference Call. All participants are in a listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at Cara's request. I would now like to turn the call over to the Cara team. proceed. Please

Michael Schaffzin

release is Therapeutics Stern results can first conference The This welcome Relations and be Schaffzin after call. Cara just website to quarter news found Michael on afternoon. today at Investor with and update X:XX our Good p.m. available www.caratherapeutics.com. and became XXXX financial

on also of the section listen webcast You Investors a may and replay the live to of today's call website.

this in development the product indications, a and CRXXX design not regarding historical pruritus remind future you multiple are our be are that the expected made that of matters completion markets Before on our the that trials, Dr. and and Mohindru, Strategy for Chalmers, statements Officer Cara's now Chief the and Participating the and and these regulatory our to our Dr. candidates, planned begin, call are concerning addressable the the Act potential cash reach. of within Private of let me statements are XXXX. timing potentially Mani and therapeutic results Dr. CEO, product our we the I'll of to by Officer. candidates our for Examples Chief of the call Securities include Financial of facts forward-looking call Reform announcement trials, over on forward-looking statements ongoing clinical the of turn statements clinical expected today's Derek meaning size option timing President Litigation Chalmers. milestones of expected

Derek Chalmers

continue completed adaptive pain enrollment call. afternoon setting. and post-operative this significant We various or us you being on trial acute and year to the Phase the with we difelikefalin CRXXX progress good in programs Thank throughout for very our Thanks advance pruritus Michael of X Okay. as we everybody. made again

During ongoing progress planned additional I'll our our summarize into this and and for this overall provide insight I'll trials year. call

the treatment injection is associated disease of patients begin pruritus for IV lead chronic in program or or me CRXXX our with which CKD-aP kidney let KORSUVA So hemodialysis. undergoing

dialysis times XX-week score with phase. of improvement injection open dose enrolling This Phase also year new unmet is this addressing to the respect During EU the X.X after week patients This KORSUVA at U.S. with support started scheduled at over investigating per quarter CKD-aP pivotal for administered of is a trial we sessions treatment at moderate-to-severe for are Therapy scale. application of currently which in Breakthrough a the measured intensity endpoint numeric of approved from primary the in for patients the injection to efficacy point. three drug of least rating first treatment label at daily the indeed KORSUVA week hemodialysis versus known as period The as extension course FDA the an mcg/kg a placebo KALM-X XX-week U.S. of worst designated the achieving trial is itching need the patients. a baseline no therapies on XX a in significant or mean weekly proportion this there three-point X a

KORSUVA and in As this targeted KORSUVA XX% number a itch worst trial prespecified XX% the enroll analysis at statistically up points in weekly proportion with XXX previously the score Xb or equal compared we've Phase that in point in completed patients that patients greater patients by U.S. intensity higher and we the of hoc our was post were to sites X.XX expected a treated treated approximately end in for conditional of this KALM-X project those weeks. three the an to X week level of At versus mean rate X from numbers significant patients. patients trial is at in XX trial XXX after placebo was XX% trial, significantly at expansion X our to trial response XXXX, Phase to in shared of enrollment to than reaching power a this baseline improvement of placebo analysis with active quarter. the allow of to the

our Additionally, as Phase KALM-X around initiate call, we we pivotal size global indicated of to also mid in design X March and similar second a to plan trial similar trial XXXX. the

currently at observed patients XX% thus already novo three six completed enrolled Phase The treatment. and as of administered a de these to initiated far the year patients of KORSUVA gathered trials. one of at this as XXX study line completed profile injection of in the have a have approximately we safety continues mcg/kg We than part week As Phase well healthy same hemodialysis KORSUVA our data prior This X.X safety months previous long-term patients to greater of in continues safety trial trials enroll X X our enroll with patients X with TIW, trial who last times XX-week a dose rate. CKD-aP. Phase the program, is and both to

we're stage X plan little of from stage with itch dose we those orally to previously placebo X of in currently estimated that these of to a KORSUVA been addition, exposures earlier X in a oral later Based doses moderate-to-severe trial patients QX at XX% pruritus. providing X data in PK non-hemodialysis diagnosed with completing hemodialysis In Phase made plasma this with indicates with safety approximately data active the or similar patients stage available stage demonstrated also relief X indicate moderate-to-severe patients formulations CDC CKD. progress in to and trial are these with quarter. XX% controlled to pruritus. studied and KORSUVA KORSUVA clinically Phase can X tablet associated suffer CKD X in X on that patients an ranging within be estimates from obtained CKD the pleased IV CKD have administered Current to a initiate Currently PK to that this patients strengths attain oral trial in

in dermal irrespective this we on cells, trigger CKD action medical range addition to given the to As or nerve initial of of address we a immune and across KORSUVA fibers and previously conditions pruritus believe pathophysiology. the potential has of indicated, mechanism

So plan with oral associated approved in chronic context we serious need investigate another treatment the unmet of to medical This disease in the pruritus. liver KORSUVA therapies this no for is U.S.

in oral we're ranging various treatment currently dose patients liver aim and for So to along of X database ongoing. of cleaning X in very completed I'm trial, Leaving enrolling and Phase trial. initiate is moving CLD-aP trial later adaptive in X PK Phase safety to disease we the and pleased XXXX. this our The ongoing currently study postoperative our with so a announce pruritus we've chronic of enrollment program KORSUVA Phase and pain acute to pathologies

undergoing curve efficacy change score time period based at abdominal postoperative trial in mcg/kg measurement, this CRXXX under up expected placebo end a on just points using quarter the postsurgery. and area of the the surgeries. patients endpoint release reminder, towards versus We Primary pain the over XX this the the X.X as to this in is the is to pain intensity hours a IV and testing data XX-hour X collected of the three-arm through from prespecified XXX trial

as of and pass vomiting And a that with both medication patient Secondary nausea forward trial and results. include pain. call and from assessment use to data Mani And summary, endpoints the the postsurgical of primary as look of well this to on quarter. global of Mohindru postoperative of assessment the our Mani? end this we endpoint rescue the going financial towards summary I'm secondary to for sharing

Mani Mohindru

Derek. you, Thank

after first for quarter results a the the our market in the be found of issued full reminder, today financial release As can also closed. XXXX press

$XXX,XXX XXXX For of the $X.XX loss Other million stock expense revenue higher for R&D and recognize share was basic average to of to quarter the for of as same in expenses agreement $XX.X same this personnel. clinical partially decrease well personnel. the expenses XXXX. which in year. quarter period $X.X Total due primarily sale Maruishi. of diluted year. the expense its our Japanese million as We compensation first higher compared payroll a net Pharma in related The increases General payroll $XX,XXX million research lower or received any of and period to primarily of in during connection first expenses quarter the of compared the was same increase well XXXX, per XXXX income in did the a period was and resulting direct XXXX in per of reported diluted from for $XX.X were loss to XXXX in the as was administrative cost investments interest we first to a to and dividend first increase and of due Pharma last the as were well Maruishi not $XX.X mainly The for quarter of XXXX in Kissei million the the XXXX. compensation of of stock XXXX compound $X.X as development net $XXX,XXX partner offset from sublicense and quarter to costs that basic or balance were expenses net included in for million quarter to $XXX,XXX for compared The income as first related $XX,XXX portfolio R&D increase quarter and revenue of the compared for for G&A costs period. related with by for share million of a XXXX. same trial clinical were sublicense XXXX with $XX.X R&D fee of $X.XX first

$XX.X in of of of The $XX.X equivalents December XX, million XXXX the balance used the As and at in primarily the proceeds from equivalents operations to securities XX, securities compared marketable cash cash cash, cash our cash, exercise of million were $XX.X of at partially XXXX. by million, from options. resulted X.X and end stock of marketable offset decrease March million

any sufficient Based on projected back existing our turn and taking plans, expectations collaborations. payments expectations. into expenses Q&A. first cash current potential half under of to to operator call expect our the I'll timing Now CapEx to that turning development account With be that, XXXX we our of operating for to clinical milestone and without financial the into will continue our fund the costs

Operator

Instructions] is [Operator question from first of Our you. Samimy Thank Annabel Stifel.

line Your open. is

Unidentified Analyst

you study PK equivalents range exact study? Thanks a few, question. oral what get IV Phase to Andrew enrollment, readout for of X and guys, looking starting do or for Do CKD timeline you Hi the us the is the will in be secondly, look I to for interim are at in And IV X second if KALM-X or this you increase on to Phase that my first the would dose one, I impact for And study? conducting study tell direct had to Annabel. also second the have how the my and need Phase your the take looking a X? enrollment is that for are indication for after? dose expect the followup second of you international analysis had taking [XX%][ph] so you of you for off the can you enrollment another a the would that is to

Derek Chalmers

start me let Andrew. so first Okay, question with the then,

the roughly seen equivalent to simply we make PK exposure to administration general or is are IV So plasma study what AUC sure we've our oral or levels quite that with of get CRXXX. exposures equivalent

exposure already our essentially. achieve, we're terms those we the we earlier, range see provided has of studies know strength looks can in tablet this active plasma patients we said in within coverage know we HD patients. as pruritus AUCs were getting that I that of And can same similar efficacy the and to So of receptor we class that in know

So that's looking appropriate.

the trial, Phase you cover arranged that. of to analysis So analogous maintain going power based whether that you and value we're correct, X a numbers There the be moving yes to the interim, seeing is given, up the following the that, on is increase the we the from X p there. an the are strength we're simply X where interim release we're tablet modeling study Then at look to interested we on IV we on know, the it size sample completed. size to is and board administration effect the as coverage need Phase conditional behind the not the the the interim no to don't that guidance the is based power into idea to in data with as Phase analysis, so

guidance that. board that size And we you on bring that is affect will rates provide readout provide would will a projected we time do given sites, question? I we if more recruitment how readout. Did we analysis that our increase recruitment guidance now as on see right any as going line the that to but what at if through so because across get point would that final your on we as trial. do active to at may recommendation give will assessment we're that have accurate point that can't change we answer Obviously we of for estimates

Unidentified Analyst

Yes, how much a of you that know, study, indication second the able enrollment need be for through you what how to direct you would would kind but is that, secondly on that? enrollment, of of get kind international with read

Derek Chalmers

doesn’t it from the No these size with those as the variability varies because populations and used variability trials patients. you patient know across and the the

directly So wouldn't relate. that

we do said our modeled for earlier have I is protocol design analysis and which power with continue as So the bill conditional standard our we trial and second on there. KALM-X

model patients. the and the with power XXX is which So and we would model start

Unidentified Analyst

for for arm, could so and an you active do you filing if and international question, international an would last international include filing? that use my and an potentially it, does that comparator that you need Got

Derek Chalmers

Well, submission you an of effective on their we in it this are you are in But and guidance for certainly trial It's at looking know. point PMDA taking required something international design this difficult that with now can submission which what's EU. terms depends for Japan, the that's as agency. very by actively right condition. no the what comparator We that for have mean to we we know when EU are guidance a we drugs active partner Japanese at for with know our you actually data use

Unidentified Analyst

Understood, thank you.

Derek Chalmers

Thank you.

Operator

you. Thank

is Alan question from Needham Carr with & Company. next Our

Your is open. line

Alan Carr

you this pain them, what what for your pain to pursuing comments the I you picture, out dermatitis? made for in atopic plans own a positive on or Thanks. Good X X a outcome is bigger trial, going that your morning. and indication? this a you of trial, Phase thinking shift them trial you the with on You’ve from be then one Phase what Phase, taking pain a would to towards look, do outcome hospital Thanks pruritus, obviously in be of my there around with extent the guess if couple questions, any it, big but are also might might you what license are about commercialize And trial setting? positive positive would

Derek Chalmers

Yes, so take I’ll the Alan. second first one

the indication. as that here based looking If for forward then a events can as the forward the look the ask something to decision planned indications that on what’s always when pain indication certainly at on to be that for data in we that guidance make people we'll registration, be we're have as we're that and announce with FDA our for discussions the appropriate So of been I've that call, for analysis. sequence just postop the out data. of data as point and and it's required the But and with at if and to postop to occurs. we'll quarter, plan partner with we’ll we'll that then doing may But and that's this said last that getting data us. go active always push these a possibility to will But still we that’s association

announced you we is to line that’s in. enough when the here times Psoriasis we initiate interested As in are population specific which a I and is decide little dermatological certainly application trial, this Atopic certainly area which we in area looking down for point correct going favor atopic conditions. there on can’t on question that with a XXXX. you’re we're we've interested number XXX associated and the at guidance. of first give and but when At of pruritus we psoriasis the the stated more and dermatitis pruritus another we’re to that on that patient design and an

Alan Carr

right, thanks taking for All my questions.

Derek Chalmers

Thanks, Alan.

Operator

Thank you.

from is Corey next Seaport. question of Our Davis

open. Your line is

Corey Davis

Hello, thanks.

one oral first clarification is The the just on X Phase a study.

it in X, of with sounded the quarter, move Phase think PK in your I correct? to but forward is kind the already said that comments data gotten decisions this data later you'd released press release enough like you’d topline

Derek Chalmers

initiation correct. We announcement announcing earlier. background I will the part in initiation Yes. be Hi Phase some likely that how as of the we is will certainly and data X that most relation to the mentioned That you? are Corey PK of provide

Corey Davis

all that look at you or...? Did efficacy in study at

Derek Chalmers

safety a in We PK did not, it fact subjects. and was any analysis, pure to did not pruritus have we for criteria related those entry

Corey Davis

That was my next CKD were question, so patients? patients, not necessarily but pruritus they

Derek Chalmers

Correct.

Corey Davis

do hit? the one study postop could And statistical of significance be to X much. very successful thanks pain the Okay, active Phase different for either for or on arms the to trial have both hit

Derek Chalmers

it then either either hits one No, successful. is one,

Corey Davis

And active significance? show are you statistical to pool the allowed to arms

Derek Chalmers

can analysis, at that analysis we is but as those look placebo. hoc certainly per post as this drug Well, a versus designed

Corey Davis

with versus to have Okay that and one question, IB as the be the that statistical Xb size I it differential less hoc could would get your what study was effect you post be that was last dialysis roughly XX% be as the still to or come up then say unless large XX% in I significance? think hoping Phase does study, the another you’re hit from and

Derek Chalmers

effect It dose as to I para but XX% up have than our we how we we on size Phase the range the we based said that parried see and against effect modeled our there size. X to that, dosages to saw then be the could look basically that and earlier across in the parried detail response less that

Corey Davis

sorry Okay, promise. last I’m one, I

would or see whether don’t would early not something that? specific enrollment, you when you that obtained on than any expect in be could it later for you’d timelines but it finish you XXXX didn’t is if data, You to depend give I know

Derek Chalmers

going Yes, that. to guide we are

this think a year our target and see in rates said will project guide we when once all earlier, that the we we later quarter later and could and guiding be to as we we be each sites as get of sites as active that these readout from from trial. then recruitment As I we topline the

Corey Davis

Okay, great. Thank you.

Derek Chalmers

Thanks, Cory.

Operator

next Brisebois Thank [Operator from Francois of is Instructions] Laidlaw. you. Our question

is line open. Your

Francois Brisebois

taking for thanks Hi, questions. the

is what Just Alan off little going a here, couple this said a bit.

went any definitely trial? has on transition do was the it of I in terms then any just that you about? that So case partnership anything talk guys emphasis there had from wondering seems or started, to pain OA that with from And to interest discussions like the when OA, the Pruritus, can

Derek Chalmers

the ongoing I said specifics can’t in we constantly ongoing we’re that for both as us Yes, earlier on to regional discussions, related as makes of specifically are latter talk for things that are to those for indications, to sense deals also but us. terms about CRXXX part talking people so deals and

of a breakthrough have CKD terms for and we it’s the pruritus that. hemodialysis designation clear patients, In at pain program lead associated versus a pruritus, moment is

condition. We have we have and a of terrific response group patients, analysis available that rate for a

itself towards along. the So move us we’re and push has data trying here guided what faster to

forward think We we we area the also is we’re that’s repeatedly an see application so in, and and CRXXX. with off an an there can data specify but partner, interested when pruritus for have that’s a we our still why that, in I’ve model potential pain said along, pushing we'd pushing pain funds likely levels most own interest like in on internal to particularly spending still

Francois Brisebois

did the response was down almost then in response, us and on the and can X XX%, great, what for helpful minimum that work the you placebo look, that’s the try around to to post just the you it efficacy to of was placebo hoc mentioned Phase terms Okay, a here? the bring you response placebo CKD-aP, remind

Derek Chalmers

Phase our from response trial in placebo hemodialysis? X about talking You’re

Francois Brisebois

and XX% there the about the just about, the response you do you I’m why said CKD-aP how mentioned is you had so with placebo placebo you anything, I’m yes I Yes, done wondering and believe for deal if it were talking high? efficacy responders and basically

Derek Chalmers

standard trials between actually and through kind not XX% tremendously XX% as of somewhere both So patients of there. type for response those that’s high pain for outcome reported endpoints, trials pruritus and

that response. particularly placebo. and versus drug over a between not a saw aspect XX% see placebo benefit that’s placebo, of can data the that’s of you less significant most set XXX response And So earlier and XX% of that is And there, as emphasized in the the we high effect placebo important I a with response. with size than drug above of significant in what difference

important that and the is you that difference that difference and of the the it’s really So there. drug can achieve drives effect

Francois Brisebois

Thank great. Okay, you.

Derek Chalmers

Thank you.

Operator

our you. today. the for turn conclude Q&A like I Derek that any And does for session to call Chalmers remarks. Mr. would to back Thank over further

Derek Chalmers

on importantly thank participating to most for the also hard everybody the team trials patients investigators, you participate continued our work Cara at continue the thank their here study like who so for Cara, day. and I’d call. Okay, in our every to

and everybody have you thank evening. a good So

Operator

this gentlemen, Thank your once concludes and for today’s you again Ladies presentation. participation.

disconnect. You day. have a may now Everyone great

Michael Schaffzin	IR, Stern Investor Relations
Derek Chalmers	President & Chief Executive Officer
Mani Mohindru	Chief Financial Officer and Chief Strategy Officer
Joe Stauffer	Chief Medical Officer
Alan Carr	Needham & Company
Corey Davis	Seaport Global Securities
Francois Brisebois	Laidlaw & Co.

Cara Therapeutics (CARA) 9 May 182018 Q1 Earnings call transcript