CARA - Earnings call transcript Q3 2018

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Operator

Good afternoon, and welcome to Cara Therapeutics' Third Quarter 2018 Financial Results Conference Call. [Operator Instructions] Please be advised that the call is being recorded at Cara's request. I will now like to turn the call over to the Cara team. Please proceed.

Michael Schaffzin

Good afternoon, this is Michael Schaffzin with Stern Investor Relations, and welcome to Cara Therapeutics' third quarter 2018 financial results and update conference call. available on X our became can today release found be website news just pm after and The at www.caratherapeutics.com.

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

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

Derek Chalmers

thanks us the on And joining call, for afternoon, everybody. today. Thanks, Michael. Good especially

clinical on for the of During pruritus. continue the or development CRXXX we execute to our third KORSUVA across pipeline quarter,

Pruritus with pivotal and Hemodialysis where trials. We ongoing, Phase Disease Injection our Chronic X CKD-aP lead are efficacy program patients, progress Associated KORSUVA pleased track and both patient in on especially for Kidney we’re enrolment the with or

its target including than like clinical acute patients first-in-class a our most opioid certainly pain pharmacology moderate acting on trial upcoming we novel our liver due receptor in for the disease unique active a disease is associated Oral our receive data pruritus on patients with with I’ll of To course the X with designed patients the to we with abuse its liver importantly supportive advanced pruritus Overall, liability back pace function are our breakthrough selective presented and Injection development to Taking V chronic to of effects, I'd and CKD-aP chronic activity an reminder, of greater in kappa pre-dialysis of to an a and and XXXX. postop setting trial that call first we focus KORSUVA diminished of and Phase that to a clinical including quarter detail KORSUVA have for pruritus. Phase we X range for Phase stage is the with to profile. support for and agonists chemistry severe haemodialysis happy as traditional X opioid also III peripherally We designation for date begin clinical each conditions, [ph] across patients KORSUVA program step very to and and to a as side greater overall programs are this with which go CKD on XXXX program through patients start, in pruritus today. progression provide trial

trial ongoing designated on our global previously, that Phase Phase program KALM-X, X or enrollment our and KALM-X We of discussed X patients KALM-X progressing design remains X began study. KALM-X includes U.S. a currently we've the safety August in and is we're January pleased and of and to dosing Phase As trial pivotal extension three well. label and report year open track a respectively efficacy X this Phase trials, efficacy in

per sessions. the enrolling phase. period at least scale with and efficacy KORSUVA week to NRS. dose after times sites is intensity our scheduled dialysis KALM-X a patients targeted XXX goal placebo, Injection by a of XX both sites year a label measured patients the achieving open three standard active U.S. proportion aim end, of in approximately worst Both designed of efficacy have XX week-XX, of Over primary active numeric are rating week treatment score mean the respect versus at KALM-X with TIW The itch to and trials XX a from for KALM-X improvement current kilo the of XX% X.X We week in or extension X-point a investigate daily endpoint per at of XX with administered to KALM-X baseline have trials. on target a weekly micrograms or

Secondary KORSUVA X the KALM-X in safety status baseline safety of mean XXXX Phase by on the desired Skindex-XX track. weekly full up for of NRS Both validated X itch-related assessment XXX the study as successful label and interim long-term self-assessment completed early well anticipate trial evaluate the and the using patients as trial, and week for the XXXX expansion pre-specified with XXXX. study Injection our proportion improvement extension life worst period XX in XX Itch than also is program patients. we X This assessment the of designed of XX% open for patients in year quality allows from Phase completion third score XXX week completion interim X-D trials of first Xb within point treatment the for for after designed The ongoing is of of XX. endpoints are study, of complete in the trial trials and of the trial to and to employed half aspects end treatment greater Phase as or to the this measure or of to up based equal KALM-X achieving the approximately endpoint that's week patients the the a analysis. KALM-X, at Based scales, the period on power on the current etching

pivotal far our adverse a of KALM-X for treatment and through these XXXX. no approximately in so unexpected the of enrolled KALM-X year KORSUVA date, We one XX% program have we very Injection study expect of treatment. and events. trials six of both at X progress pleased in announce complete with recorded We with from have number over overall to the remain with data To patients XXX Phase months we on patients

point CKD-aP in to designed generic we therapies. is X.X CKD-aP pruritus per estimate an daily exposure three evaluate X.X primary compared oral stage the patients approximately area score numbers to placebo. KORSUVA need So with migs of KORSUVA this daily In at XX we oral pre-dialysis in treatment megs to and of X.X clinical clinically in related both KORSUVA of rating IV dialysis migs, dose treatment the meaningful no level achieved multi-center and levels for patients dose change significant XX intensity tablet baseline a double migs and randomized This the equivalent X trial on for FDA of stage unmet The script in itch, the CKD experience X in with last given XX achieved significant of scale patients efficacy to is The and patient X exhibits exposures KORSUVA range kilo once blind from population to period. that With the statistically of reduction with approximately mind, that and Xb year the alone of patients. million efficacy worst X X trial safety of week X one next numerical endpoint patients. hemodialysis X exhibited based the in approved in trial. U.S. week began dosing July controlled that our U.S. in the oral a is placebo trial providers itch weekly of previous Phase – in mean phase were

than have XX as by itch, change the as week trial, an proportion arm of total worst that in XX of points interim score life XXX enroll expansion week with respect itch-related we'll an as for patients. to equal treatment itch for up X to or to weekly improvement who to those scores of We XX% and from completed from the XX. NRS patients, patients per of the study Secondary XXX of assessed this analysis well X-D of Skindex-XX endpoints and conduct enrollment or the un-blended at allows include plan baseline achieving mean a quality baseline and greater

currently of XX target XX% pleased Oral trial KORSUVA disease also on XX with are this that our affects patients liver of disease. expect We're XX% exploring of which pruritus, to sites year-end. is with than active greater by sites, cholestatic track We clinical reach approximately and in liver to associated potential chronic the chronic we

the aim treatment of within of enhance quarter or moderate and liver I year-end KORSUVA initiating is liver Oral X top enrolled, fourth Phase by and phase severe Oral chronic for pruritus and data disease fully PK the year XXXX. disease safety and of this of early with Our KORSUVA the patients we expect to trial now line trial of mild, associated

this in conditions, Vice as and Celgene for As for including pruritus Cara were medical to since in guiding like quarter. to a of dermatological team XXXX President that, Medical need. the of and is expertise Affairs I dermatology this And to a call financials mentioned Neurology, cells, October may therapy on serve on look turn and the to by occurrence the KORSUVA's brings who the in discuss in past for mechanism dermatological believe team particularly an recently across affairs will of [ph] as Mani, treatment calls served kappa I'd so very Medical forward clinical most clinical we clinical And in receptors that sensory with peripheral mediated development immune important action the future. Cara the as novel she very KORSUVA products. regard, remains where Chief joined recently we addition over pruritus pleased we for Officer. Dr. the third extensive Dermatology plans conditions in significant development for Goncalves, and our to Mani? from announce conditions executive Joana Oral we expanded our near she which team, unmet with have now with medical treatment In resistant Joana range

Mani Mohindru

and Derek, you, afternoon, good Thank everyone.

share milestone license for third during of fee Renal $X company Pharma or period revenue Medical third license our quarter related the recognized VFMCRP, Group fee milestone the Fresenius Vifor XXXX of or found with net earlier quarter XXXX million diluted for press third financial share We our per per and $XX.X of after today reminder, a $X.XX the loss the a reported was a diluted quarter can the XXXX the third of market net or in during quarter basic million There to of XXXX. that As joint was no to agreement Care. release of issued Vifor We and and basic and of $XX.X full $X.XX Care results loss Fresenius same compared license closed. million Medical and for a revenue recognized the XXXX. Pharma of of be

clinical XXXX Additionally, of in we higher in compared These third The with quarter such the to due clinical XXXX our the costs costs, same the to lower connection Maruishi of No revenue of R&D clinical $XX.X R&D in sale expense well third also recognized recognized $X.X increase R&D quarter $XX,XXX associated were offset compound XXXX. in expense cost. partially of period in revenue compensation compound was compound during trial in quarter XXXX million stock the Pharma. in as related period the as with increases of of of in as XXXX partner These were the was well an third XXXX million by in consulting to and facilities increases compensation were clinical $X to of average balance to during $X.X million the XXXX. personnel was higher expenses income in of portfolio expense, by Other offset XXXX. the XXXX. increased decreases million quarter was third fees. same $XXX,XXX $X administrative period. same of partially to compared decrease investments This due in quarter of in to conferences. the million compared increase and legal were company's primarily in as period due cost. and primarily The of related increased decreases third stock XXXX expenses the XXXX General were

the XX, to $XX.X of securities proceeds of cash, agreement securities a proceeds related raised $X.X September $XX.X compared million cash offering to from at marketable the December $XX exercise $XXX.X stock license XX, million of XXXX. balance of from July and equivalents shares, the the well million million as options. of net from X.XXX XXXX, The were resulted increase VFMCRP, in and As million cash primarily as million with follow-on marketable of

expectations. financial our to turning – on turning Now

requirements CapEx will costs we existing timing I'll payments our our With back As be us on our of projected that, XXXX expect existing previously stated, operator for the turn XXXX fund sufficient as securities Q&A. of any that of development cash, operating and equivalents our based call and the the for plans, XX, account and milestone to we cash into potential marketable without over expenses September our to collaborations. taking into from expectations

Operator

comes Thank with you. Jaffray. [Operator Amsellem Instructions] Our from first question Piper David

open. Your is line now

David Amsellem

Thanks.

Just couple of a quick ones.

own? on as And Is apologize walk dose thinking just in you I could commercializing in \ - So you how that's commercialization to you how at about responder something going that if two, the you're the Thanks. X-point to overall So about just liver the setting? you're the through in trends as be are us think your liver also number will just And number looking how you're that partnering test at on first dialysis steps and out should And study, are one. missed within looking [ph] you we opposed setting? us of Phase analysis through about this, walk then thinking terms X? I design? next

Derek Chalmers

a Thanks, once down the quickly, of about we line versus little that's generating of at strategy there. look terms lot a the indications, little we further to David. so we're To are something we'll just of data the any a questions, address think commercialization other in early liver

that's design particular terms stage seen us most to you've be use The we endpoints that, We'll day actually and trials. the patients the Xb quality different know, with when main day patients patients and kidney between that would in of the at in issues design CKD-aP have [ph], design scores likely itch similar. phase beyond same and life those actual to of CKD-aP endpoints liver those once our function to phase for In dosing regimen is for trial. the patients, of than likely we and then first in to would close twice baseline that does range they're That a to be two pretty in because as but used start the CKD X we'll worst and difference level be will trial announce going all intensity you look X from very the most be the allows dosing in going of hemodialysis looking [indiscernible] X. The some a that. terms looking

David Amsellem

psoriatic is psoriatic [ph] you're a improvement settings on a in in Okay. settings, a want up in sneak X-point I to at the follow responder analysis here. and more And looking know I different based other or few NRS.

is So it's we CLD, of points points, conditions? that in X to what's through you you we've confidence that opposed points the level get X X need responder know, the whether or hurdle another certain analysis in seen dermatologic dialysis, to that indeed as non-dialysis,

Derek Chalmers

David. question, That's a great

to And empiric as so on think analysis. we really appropriate based

CKD meaningful empirical went our in I changes data, think to statistical clinically analysis all statistical in that analyze clinically of And breakthrough that on our undertake including and back something this convinced Xb FDA, particularly we've and is analysis, patients. there, versus which meaningful NRS we've X.X calls covered relation the interested when on previous and standard CKD like to we NRS to we those designation, based a learned inn reduction for what which actually the our in, patients. points phase was analysis we're way analysis all reduction, there's in QOL, the

Phase proposed that the X to at meeting. we So Phase was with X of obviously the discussed FDA that study up and therefore, our that we X points bump design end

there patient, also edge other we published, populations, looking analysis analysis less good at the of to - for decided populations, yet and there atopic dermatitis.. we'll I haven't and validations be when convincing some things subgroup psoriatic some these fairly get like is particularly For dermatological think is absolutely we on dermatological and

will in but based reduction be subgroups, analysis So really clinically empirical our a CKD for get baseline. we our we those in the meaningful endpoints announced when to particular from on that's patient particular, of

David Amsellem

Thanks. Okay. helpful. That’s

Derek Chalmers

Thanks, David.

Operator

you. Thank

Our next with question Samimy Stifel. comes from Annabel

open. now line is Your

Nick Rubino

for Mu kappa How on How of Annabel market, is the see in entrants to you as This to our oral specifically Thanks Nick yourselves combinations? changing taking be agonists, antagonist landscape other there within light for pruritus you from position the plan the several everyone. do Hi, new Rubino do Samimy. questions. options? seem

Derek Chalmers

Nick. Yes. Thanks,

we're terms other out there. about options if talking is pruritus, in there no of So CKD-related - really

the drug design we are class. type RCT think standard shown a I there in in that only that fact particular patient effectiveness for

So most effect Xth we the from basis that for pruritus. opportunity ahead was the haven't any an agonism seen biological patients The - alteration, of effective otherwise And do suspect to there. out And I designation late there effects be comes on at breakthrough or have in agency to the would any or other rapid modalities, aren't antagonist all. that a that it kappa that first-line of are those in the But kappa is basis disease our subgroup, selected beyond those but horizon approach is pruritus there on approved. of - resistant those the there. you the Mu there probably of that not are there are other any there. when on and effective seen treat peripheral dermatological are dependent have development situations, have Those if at the a to there, biologics look other we've any out stage that in been agonist, very that obviously, obviously come opportunity, again, that number

Nick Rubino

you. Got

or the you you forward any discussions how that value study, discussions Phase capture internal programs program? to earlier Okay, the backseat move may had thanks. pruritus, reported And with but you have as taking follow-up, to quick any this to had in regarding guys FDA have of X, the a meantime, the that maybe X year, a just pain your pain know post-op you successful we are

Derek Chalmers

Yes. Yes.

right we're the like two U.S. at and if on we're and from feedback particular looking We're what hospital data, And relation end-users, then now analysis developing to and a both in lacking what's relation the are that the in anesthesiologist labeling consulting - to qualitative for target agency particular itself we things. in are in profile on soliciting in So running based and PONV the we likely that program pharmacists that. with at, vomiting looking that the the setting. there in to some on process requirements have aspect nausea and the relation questions of there, postoperative you most

and certainly we have hand, we're And So those that path that that where for us to guide forward, particular are we’ll a going the things with they ongoing two in decide are that on when program. we program.

Nick Rubino

Thank Awesome. right. All you.

Derek Chalmers

Thanks, Nick.

Operator

Thank you.

comes Genuity. Lee Canaccord next question Our with from Arlinda

Your line is now open.

Unidentified Analyst

Hi. for Its calling Ben questions. our for Arlinda. Shen Thanks in taking [ph]

Some were of is you thought I patients, being its designed trial, heard been double answered. that I talking wanted liver I to just to about the the correct? that earlier hemodialysis check, potentially similarly

Derek Chalmers

It's patient designed X similarly stage X the to No. to design. CKD

to start reduced oral announce be going a we it's the trial, KORSUVA trial. we dose at the range So an twice Probably when will day, a dose.

Unidentified Analyst

it. Got

Okay. guidance, bit to tick next of a something quarter, is look With there is order that know the quarters? for but that we magnitude this expect of give can of I respect sort that pace guys to R&D don't you a up few officially as spend, and can we

Mani Mohindru

XXXX calls do As previous we've expense expect go up in the this R&D we our versus in to said that XXXX. year

proportionate of with progression contracts will choppy nature that. little a sequential is bit this harder one, of its be and to the trial. the in given to line the say, this Whether So increase the

last onwards. to year be difficult it's increase the specific, but on that from So it's

Unidentified Analyst

you much. Thank All very right.

Derek Chalmers

Ben. Thanks,

Operator

Thank you.

comes next Our with Needham. Carr from Alan question

Your open. now line is

Alan Carr

[ph] any X is data to you patient And trial you those sort have my X will respect the Thanks your the for wise Can considering patients expanding analysis when liver about Hi. you're speaking and/or the for population? early Phase report see of us you Thanks. then to just trials? the pruritus? with questions. it What taking size on disease, Phase of talk

Derek Chalmers

the pruritus, range Thanks, and and the just so question, forward. dose PK any latter no carrying Alan. quickly just don’t for safety To obviously they have there, analysing its

that we announce carry we when will the former committee forward question, that from sample the monitoring IDMC, data as interim KALM-X On complete independent size the trial, within we trial. the recommendation the the

something guide be we'll we have that complete. once So to that will

Alan Carr

But the recommendation that? than the or to trial, anything efficacy seeing will be of they a just any with like more on size nothing respect

Derek Chalmers

as we've No. no a Because P analysis [ph]. attend as before, discussed there No. is value power conditional

alpha to value an there take don't P no analysis, they we So report so is as were.

size. report sample recommendation received will our we of IDMC So terms from in we

Alan Carr

Okay. your trials of X you’re to [ph], like And broader dermat indication? subsets a parallel? plans that then sounds with Phase thinking a move Or few forward thinking few respect patients. you dermatitis much of how in of you in it any Are running

Derek Chalmers

couple and we're internally as program. what right first we'll Yes. there, the going on discussing come now, the get we simply and That's where we're just fairly organizing Joanna next as get Alan, announce to that something in year last board has that in obviously, early to we’ll weeks, there. and subgroup her patient once sense around But we're particular terms with that of made of

Alan Carr

for Thanks taking questions. the Great.

Derek Chalmers

Thanks, Alan.

Operator

Thank you.

from comes H.C. question Livnat next Our Oren with Wainwright.

is line open. now Your

Oren Livnat

folks. of questions. a Thanks couple Hey, taking for

any been the might affect prospective partner there has that ability reimbursement or or ESRD Firstly, payment your [ph] you to life either unbundled for bundled get the updates setting? hemodialysis in recent changes

Derek Chalmers

Yes, you are Oren. thanks correct. Yes,

So we're - pleased. very actually we're

the adopt a payment drug transitional ESRD setting there. that receive to you there's add-on CMS would and been approved drug know, after the XXXX any As so adjustment new a automatically from recommendation on payment,

establish good drug, marketplace. the in for and news know ASP we're get to to us. that and the So KORSUVA going give going it's launch that's opportunity We for us to

So the and we're proposal CMS. recent with very actually from pleased update

Oren Livnat

plus ASP that's And zero, correct?

Derek Chalmers

zero. That's plus ASP

Oren Livnat

do plus Or your has you think product the And as zero headwind? just any it is long not goal? as a to economically ASP without [indiscernible] Okay. mark-up

Derek Chalmers

advantage have that don't going We there. relation in teamed commercialization Vifor be the to you've with we're and that developed and indicated and think we as us Yes. Vifor taking Well, that was Fresenius up to that of reasons so, one with remains seen. to that be the of Fresenius relationship

unmet a -- an So need. drug so. And we remember think that's meeting this a is don't

alternatives in it no treating symptoms. And severe this here so there is really

going to that's severe think be don't a headwind. we So

Oren Livnat

powering on the wider to you perhaps Great. you with and still be substantial flex bandwidth the it catch may to analysis, it study? entire conditional maybe to your… with a can you're Or time open that going - the having and size length regards Thanks. out increase that of as the turns anticipate sample to impact enrol takes And materially, do you that up do

Derek Chalmers

No. terms - anticipate where We today even treatment sample to period there don't status, XXXX. on is stated we think within the going based are of adjustment in of size, we XX-week I this in enrolment on and first an if in full we the we're call the half complete that

Oren Livnat

Okay.

QX, expand this you you at it, if thing. be If point? don't Or would comment material it different In didn't in a all it to you want be don't did? QX, at better you expand, - would if

Derek Chalmers

get we'll Well, complete. once interim we that to the have

something provide granular that we on have that will complete. We more once

Oren Livnat

All right. Thanks so much. Appreciate it.

Derek Chalmers

Thanks, Oren.

Operator

[Operator Thank with Our you. comes Instructions] Ken Trbovich Janney. next from question

now open. line is Your

Ken Trbovich

data, vomiting. anesthesiologists pain and about surveying you just mentioned and surgeons the and you postoperative Hi, hinted Derek, curious I'm about nausea

I'm whether product or some that So of curious focused pain from profile on combination vomiting the of and the nausea I survey of sort separate guess about is two? in terms

Derek Chalmers

specifically. care which was that - That the on post-op for the our of That is No. we question. within X-HTX are Thanks of standard study. population, aware patient of on And based and late-stage used Ken. that that Hi, profile antagonism is product standard for data PONV top all

solely we're at. based profile on product target looking the PONV that's So

Ken Trbovich

Okay.

get decision you that looking continuing on are a to suggest things those make you're partnering to before does development answer So internally? that or

Derek Chalmers

that's we're for that, the too, suggest exactly. does looking That answers label

Ken Trbovich

Okay.

out-licensing guess the answer? So wait I does get to you're Or alternatively, you're going until open indication the pain is mean to that that already? you something

Derek Chalmers

right? the molecules and walk window and at need effects, larger things for relation to traditional sure So response of nausea seen in [ph] the population clinical two side opioid is is unmet terms data of go through know hand primarily in that vomiting. reduction in the and Well, the greatest to PONV in you've just course, those analgesic the hand guess, I we as from

would sense most co-administration it PONV response you primary analgesic label. sense So makes there. addition a But that given And our after the for that should be the our additional data get we for makes with and like as benefit molecule set. an an probably patient population if

Ken Trbovich

just does that the about final 'XX. not Does Then data assessment commented midyear? half question, require see completed expansion we suggest the the during press first you by that one XXX I being know XX-week that release in the to treatment Okay. period the of

Derek Chalmers

going period point we're the that make status XX-week that at But assessment. is implies finish to interim that the this if after is to finished Well, of to we a get we can adjustment us enrollment once prediction interim there analysis. the size allows even what a the the treatment sample

Ken Trbovich

sounds good. Okay, Thanks so much.

Derek Chalmers

Ken. Thanks,

Operator

call I Derek concludes Thank now the to today's like over you. This closing turn to will Q&A back session. Dr. Chalmers for remarks.

Derek Chalmers

study well soon. continue investigators efforts development our everybody very I'd families, for also again, to thank updating we support the Okay. as participants, as to and who And all Thank you, again today's patient like and thank forward everybody look in of call. to, for KORSUVA. participating their

So thank you, everybody.

Mani Mohindru

Thank you.

Operator

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

a You disconnect. may Have day. now great

Cara Therapeutics (CARA) 6 Nov 182018 Q3 Earnings call transcript