CARA - Earnings call transcript Q4 2017

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Operator

Good afternoon and welcome to Cara Therapeutics' fourth quarter and full-year 2017 financial results conference call. All participants are now in 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

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

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

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

Derek Chalmers

with us good afternoon and today. Thanks on call the you being for Thank Michael Okay. everybody.

progress we pruritus to a or through advance continue Cara here our programs. certainly at us was for XXXX both year pain CRXXX difelikefalin of acute and significant So as

summarize as milestones. progress, planned During some our the additional as our into and well this upcoming I provide trials ongoing insight overall provide will afternoon, call expected

indications. for trade conditionally name for Let pruritus with accepted our KORSUVA, begin me CRXXX

data in from kidney Phase Xb positive CKD-aP of in reported we KORSUVA undergoing our controlled patients trial XXXX, During or chronic injection hemodialysis. pruritus placebo disease-associated

for U.S. And Meeting this X pivotal for support approved started KALM-X moderate-to-severe year. hemodialysis of indication. also We injection for application therapies new treatment KORSUVA X significant received QX a also year, which unmet U.S. the X Phase Earlier currently are End-of-Phase of our need of breakthrough trial, the known there therapy designation no this to for also last enrolling patients as laid in KORSUVA for a initiation successful patients, CKD-aP pivotal in Phase the drug program foundation for after we in we in a the

In of patients non-hemodialysis the also diagnosed year. completing Phase X with XX% to X X associated X trial estimated are the addition, with patients patients in are with Phase moderate-to-severe pruritus. these to this estimates to currently assessment made KORSUVA a will this design from oral the inform dose Data CKD. progress of trial or X we selection and in to earlier oral being trial KORSUVA stage with pleased of Stage plan in X CKD this associated we Stage of and patients quarter from Phase pruritus X Stage X of that indicate CDC X in trial Current with CKD XX% suffering second initiate in approximately an upcoming

believe no medical the plan potential this the as In therapies mechanism cells, the action we pruritus trigger of context, conditions, that KORSUVA irrespective and Given approved the of its of pathophysiology. has or unmet need KORSUVA other the to well we KORSUVA's treatment investigate for address associated in across the chronic pruritus liver to range of U.S. opioid and initial with immune disease serious is dermal target receptor, as that receptor medical fibers on a kappa nerve

liver chronic safety chronic liver X Phase patients of later KORSUVA initiate with pathologies and treatment of a the disease Phase XXXX. disease the initiated already pruritus oral trial aim have for X PK in of various associated We to we and in study

KORSUVA Now in let our me provide hemodialysis some of program, Phase for X lead patients. CKD-aP moderate-to-severe treatment the update and details on pruritus

pivotal been over injection initiated dose at achieving point investigate XX with addition. administered open from Phase three kilo a and measured label extension per numeric has baseline scale X.X KORSUVA score a improvement first treatment after trial that's The endpoint at to the to XX-week phase proportion period daily is of scheduled versus is X The week worst respect XX-week the or in a primary per least intensity efficacy of a itching dialysis mean designed placebo times on three with rating microgram of at patients week sessions a that weekly NRS. a

in the in of in week Xb post-hoc significantly eight reminder, and statistically patients Phase XX% compared KORSUVA score worst the at was of greater three versus placebo, trial, to from patients analysis itching proportion higher an a our KORSUVA As with the mean to patients intensity placebo. than XX% or a completed equal points baseline treated in weekly improvement treated of

at the to power enrollment conditional of XX% hour in patients trial patients that Other expansion of itching endpoints validated analysis at Skindex-XX X-D XX. a daily four itch, the as the quality patients as week the XXX measure Phase previously in indicated and our of to a at employed worst both is XXX X mean enroll NRS of score prespecified Phase Xb achieving secondary scales, to in allow improvement will trial approximately aspects self-assessment proportion least Secondary the endpoints weekly to from by The up with completed these trial. point using of include baseline expected analysis. XX life

of of we of patients. novo trial safety of Phase microgram as KORSUVA patients enroll this at trials X who dose completed a continues in program, one Phase of a X X.X our injection kilo study XX-week HD well part last safety long-term in This per initiated year. As patients previous to de as QX

international X an Phase initiate pivotal trial to XXXX. mid plan also we around Additionally,

in look each we the quarters. trials over So updating these X Phase upcoming on the forward of to progress you

to lastly adaptive ongoing postoperative our pain along program trial. Moving acute X and our Phase

in topline from this this we data trial nearing of quarter to are expect We later the year. completion enrollment second announce of and

arm Patients pain XX per through post-surgery. XX undergoing hours the a pain at As kilo pre-specified microgram postoperative this on The at versus score doses area in room is XXX the six, second patients is the recovery are CRXXX curve surgeries. efficacy XX receive measurement placebo dose abdominal a three dosed one of XX-hour primary post-surgery. subsequent I.V. one in period surgery trial testing over based to prior change a using and under in and reminder, the with collected along up the and X.X the AUC hour endpoint intensity or the time points hours to

vomiting setting and area need endpoints high as patient and rescue quarter the study remains look assessments global this the as the of Secondary well in in this the of include assessment unmet of during and post-surgical an year. medication sharing management postoperative post-surgical use of to of forward pain. nausea second we Pain results

as can to X in nearing planned programs us as these as trials So trials see, completion a have pain Phase provide execution we and coming the of you will and well trial upcoming busy year ongoing continue pruritus with months. we on our already numerous updates acute all ahead

Mani? will financial with that, on to I So call Mani the pass for results. our

Mani Mohindru

Derek. you Thank

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

$XX.X of For or net compared December share $X.XX year a the or loss basic to we and XXXX. million XXXX, a share, reported of $X.XX loss ended XX, net basic $XX.X per diluted per and million diluted for

we were increase were XXXX to for the clinical or in December of the a in other in expenses million XXXX diluted fourth year other costs, quarter $XX.X basic higher share of related the quarter expenses prior net in were from the $XXX,XXX $XX,XXX compensation related $XX.X period higher included fees Revenues related the XX, Research for period XX, increases in not expense rent income $XXX,XXX in XXXX clinical year XXXX. primarily million R&D in basic as Pharma. XXXX, which Maruishi $XX XXXX XXXX, of the to compared of were average $XXX,XXX revenues a were fourth fourth net increases and quarter for quarter a our XXXX lower were fee as Pharmaceuticals, R&D versus due ended $X.X in balance expense compared during amortization. XXXX. $XXX,XXX or same the costs. by same decrease million income dividend of compared net share, XXXX of related other costs, to XXXX sub-license any in in Revenues We for $XX.X lower reported same or XXXX revenues $XX.X million of the compared clinical were million higher recognize were to fourth Maruishi $XX,XXX to personnel $XX.X was $XX,XXX quarter stock expenses in $X.XX milestone Other million the primarily on to G&A administrative development compound a and primarily to were million $X.X a the in lower in quarter the expenses. interest compensation $X and partially which and No million same to XXXX. Revenue in by was with of and Other trial with period of R&D connection either partially due XXXX. expenses and expenses was expense XXXX. fourth primarily million for $XX.X $X.XX income compared in diluted to million million year compared loss XXXX partner, and expenses. due the The G&A and as in rent expenses for its mainly to fourth compared quarter period per XXXX. The amortization due and stock-based related sale compensation of offset and to per stock-based to investments same XXXX, of the XXXX. prior were are year. fourth and period. General did ended December For XXXX. XXXX. to received of and for in expenses compared loss sub-license The in decreases were recognized Kissei XXXX in $X offset in XXXX personnel license The agreement our to in trials, in higher primary payroll

from from by offset partially operations. was $XX.X that offering in and April XXXX in the as at our of of equivalents compared securities marketable $XX.X As million million and our stock net XXXX, to $XX.X million of from were resulting follow-on of December $XX.X XXXX, exercise XX, proceeds cash reclassified million well proceeds cash the stock used equivalents, the cash, of end cash of restricted as option to cash, from cash

Based requirements our Now expectations. on and our clinical projected into milestone will expenses plans, over back and we be I any cash cash, development the and Liz? securities to to first to expect turn turning costs capital payments fund With operator Q&A. our XXXX operating half potential call expenditure collaborations. current financial under of existing the timing on sufficient to marketable for without equivalents of our expectations the that that, effect giving

Operator

[Operator Instructions].

with of Our Jaffray. Duncan first Charles question comes from the line Piper

open. Your now line is

Charles Duncan

provide and started? the Hi And that guys. to am that study the size on in you international underway me. to you the start mentioned or of can additional this am if later for any going Thanks The were you study? question. the what KALM-X I are scope of airport. kind study States that wondering an taking year. gating an Hopefully is I could hear getting I you in steps color think

Derek Chalmers

see. me let Well,

a of little all, you. hear out can we Charles, hear you. bit, can we So In first but and

in time. mid-year. that So, similar that get and in international are required now, steps design, study we on sure terms endpoints are to of study a second terms with is to yes, be U.S. and we trial the preparatory the can we to right planning scope initiated of CROs going undergoing starting The of size very make

Charles Duncan

a is it you regulatory strategy, the to FDA an strategy? to meant provide MAA? enable second for and international U.S. meant the when study Or the for the And is study its consider

Derek Chalmers

Yes. That's question. a good

dialysis So the is you centers the of international U.S. ongoing and number and there this, studies. primary a Charles, number going here of there know a rationale in for is finite

can make So these studies we rapidly would we to as sure like possible. as complete

ex-U.S. us to run sense not the with trial with complete makes in ourselves for it U.S., look and So our the territories

Charles Duncan

kind you it? Okay. of think either silly it's is any your like question being the then going am maybe or do to is work the That a I pain the of work I you not appreciate you final going seem on may working thoughts acute it's the wondering And makes but Obviously look But different going question. study. scenarios, prepared through conducted. sense. This different scenarios to on or is that how remarks what have what study in are further you that's for?

Derek Chalmers

Charles. Well, I talk to am Joe going that, to let

Joe Stauffer

Charles. Yes. Hi

of So work. a as X.XX That's situation. the as study primary than as safe really less The I black have It's endpoints it defined study, study to think and are already P or positive also going It's to positive you right. the articulated. too. a on has going a be either it's a is not that work Obviously, based part we p-value well. white to

comfortable that very data blinded, there. know. based So the from so the standpoint, on standpoint, and at we I what safety And time we we still don't feeling look see all From that an how to efficacy are really think consider postoperative. positive, the If do going us have that to negative, trial, If steps. about trial. we in we what next with design it's tells are it's to we

Charles Duncan

Okay. question or if wondering a of would regarding would on that evolution it terms positive, trial in That sense. and establishing just you of the commercial pruritus final forward one company. presence. sense am makes make move I of focus more kind or yourselves CKD-aP the to then is really And

Derek Chalmers

Yes.

as come indications. though So will possible. comes want the as there well to focus pruritus when Charles, make little along. exploit is that We to we the are yes, at as a But you later correct feel opportunity a decision the we data quickly large as there minute certainly our has that that around on

planning And year. three that initiate are so you we to studies pipeline see from this our have to we four pruritus

indication becoming focus the main along. of on is application postop and comes data that as and So that trial we the a the company decision make the will

Charles Duncan

the [indiscernible] see progress, to makes the sense That a and questions. lot to for my of thanks pardon pun taking

Derek Chalmers

Charles. Thanks

Mani Mohindru

Thank you.

Operator

Samimy comes with line from Annabel of question next Our Stifel.

Your line open. is now

Annabel Samimy

for taking on from Thanks congratulations study. my me questions your and Hi. pivotal starting

at feed efficacy For extension. the those satisfy pivotal the FDA the extension trial, perspective enrolling a XXnd also safety we the of internationally into Is pivotal and for are that safety have current the XX-week all, safety So this the patients requirements the week of requirements are comprises from fulfilling first reasons, study from pivotal second first does extension? that see start that trial second and to from XX-week that long-term into that requirements. you to looking safety were

given feed starting each what field for Phase dermatitis first different Thanks. guess, Xs So oral I that's what my question. in the of, a regard. And X perspective, moving rationale rather also is going two be starting So Phase into Phase in early-stage one then atopic new in are indications and indications? also and just in indication doing identifying that you X multiple dose plan on starting to the you to from different development is up the than

Derek Chalmers

Annabel. Thanks Thanks Great. for the questions.

three there as are maybe got have you well. then four So and

to population to because the oral in an made Phase is Let I important there PK Xs we relates with point reason think all The here. run be me the differences. different these start patient question

So obviously pre-dialysis Stage X, varying degrees within is dysfunction. kidney that the there X population CKD to of are

efficacious are population. in levels sure match are exposure those know we to And exposure our to within patients so, levels make we been can we very very accurately careful define HD

Same have dysfunction. reason them, these for you majority are, So the Phase liver Most very liver sick patients. run the that's have the dysfunction. certainly concomitant know, X as and to kidney the They also there. population of

terms That's there little the a we Phase we of so go PK we different sure indications. exposure move before to dermatological studies. want the get we again, X And when in into to correct make

at guided individuals dosage population function. populations. you in, you for going up haven't to X kidney healthier completed are to those which have We to normal part, if be tend most we us normal look week repeat there. And one somewhat we already studies But like, know, the Phase to with as younger,

which on that safety faster on X safety we roll decided the patients certainly XX-week will can we we Back guide requirement. Yes, into on your will when decided a we first program. and The correct. Phase there move move to there little are patient as and both into question So design. and studies from that's the studies population you to a

ICH chronic from XXX know, for guidelines exposures exposure up you As six-month. to to we therapy, months see need with XX length exposures and XXX at

for Now, indication. do this breakthrough have designation therapy we

the bigger something as develop guide We to changing. That's database will frequently. agency be a and numbers the do we now, those we certainly can't with talking interact have to possibility but agency I right a safety of more

Annabel Samimy

Okay.

I could, what completing miss you study I up start Did it week you going when to or I Phase if just I the Phase follow-up second extension second am the X portion? wondering Just X to that. to that on mention extent going a study? have did XX were is hold

Derek Chalmers

we No, to mid-year. start going are that

are that right now. preparing going to We actually get

Annabel Samimy

right. much. Great. very All Thank Okay. you

Derek Chalmers

Thanks Annabel.

Operator

the Our with line question comes of Alan & Carr from Company. next Needham

now line open. is Your

Alan Carr

and blinded Hi. Thanks from do started, then around those And making up, indications? just And wrapping timelines when some will pruritus, a of bit think But postoperative on the you have for the can of last preliminary first taking a you patients from trial you you Phase see on are regard you sounds any characteristics It And decision which data skin. guidance out X also around you you from trials? process some the X/X pain comment with the questions. Thanks. comment the indications one sorting pursue. have that of is data like there a might are And data these in start then when can you about well, versus safety that Any one on might the the more that's maybe when what baseline which in trials? also, of perspective? in other trials those? the you Phase might to

Derek Chalmers

Alan. Thanks

I So postop talk safety the will about let so resident our far. data we anesthesiologist have

questions, as skin couple the next something in and on guide initiate patient forgot hopefully XXXX, to decide first we two question? that will of but of we to your the aiming the And will the in indication, I we design other in That's that's The to guide there. was terms something population quarters. we what are

Alan Carr

That was around --

Derek Chalmers

X we Phase data? to Alan, expect we trial. When see As initiated know, you that Yes. just

to once that we part XX the and to we see up pivotal when Again data get expect and from of see enrollment will have rates the sites We to various guide expect to process. recruitment as from trial. first XX sites, running we these that we

Alan Carr

Okay.

Derek Chalmers

And Joe to color. postop on is going you some the safety, give

Joe Stauffer

Yes.

surprises I On the safety postop, no on there. the am expecting Alan,

hands We have risk-benefit that the from around the that the throughout perspective the safety the time of trial course safety and benefit data have all comfortable our feeling looking we quite drug. the at of a there profile here and

as As quarter. far efficacy as it's still far as goes, the second the blinded. timing And goes,

Alan Carr

baseline coming? population patient the the this overall How's characteristics in trial? of And it

Joe Stauffer

postop a as patients other ones, ventral into of going twos, the will half And will the the healthy trial half threes sometimes The represent relatively trial. they hernias. the pain, are be about Hysterectomy OR.

Alan Carr

Okay. very much. Thanks

Joe Stauffer

Yes.

Operator

from Canaccord. next Arlinda Lee Our comes question with

open. now Your line is

Arlinda Lee

to trial am curious then of trials? that renal for can pace, different the I the the going be information about data your and functions factors XXX how maybe patients, follow-up the guess, additional guys. i.e., then Hi into what by pain I oral for I be that may might will If how second? enrollment my guess, might trial first set the the pivotal. of what play pivotal can on trial. provide trial When Maybe be kind additional did timing the second on enrollment? you you look that plans to and about and timing how you X, postop impact And or doses that complete different indicate Thanks the are on I might like, the Phase might the expanded taking question. into And of lastly,

Joe Stauffer

it's guess. So three I questions,

Derek Chalmers

Yes. Arlinda. Three questions,

can then can talk and the take and about about I one first oral talk postop. last me then Let Joe

the to just our X. moving the raised, label pivotal for the rationale one for essentially, So Phase international is either whole trial last open ourselves with is, issue or you competition avoid which to is first

the have this that will a patients initiated by are provide get U.S. the So year. to we that we territories trial rationale. and good the mid-year We roundabout running handle which is think on most with

So we in think that does us terms of recruitment help rate.

the CKD X Phase I.V. we to see release oral and you will X, to well will that patients data we with we trial patients, Stage treated that in that the mean exposure data On see are I data into an presume exposures X and relative you HD

strengths the more to So HD active in those patients. patients which with HD in looking are I exposures as that HD know equivalent is CKD in tablet we for say, other analogous moderately us would are words, predominately impaired what the seen much I.V. give patient we patient to the have in we

that to exposure then So the it's going tablet predominately And levels, in I.V. match comparison you impairment a trial, postop Joe? strengths on patients. see moderate HD and will exposures of

Joe Stauffer

You enrollment. about asked

the So finish quarter. up and report that will data second the quarter in second will we enrollment in

Arlinda Lee

quarter. second Early

Joe Stauffer

you have can data, enrollment that right. to Well, before report you complete

expect then in that we the will when the comments, readout I So and think quarter. in to we quarter, Derek is second enrollment early trial complete later second made the

Arlinda Lee

you. Thank Great. Okay.

Derek Chalmers

Arlinda, thank you. Okay.

Operator

from of Michael comes question next Securities. Jung line Seaport with Our Global the

line open. now Your is

Michael Jung

taking call. Hi. Thanks my for

the Just of formulation question pruritus? the patients patients on with a for treated on these see oral quick I.V. Do being dialysis. you for peritoneal

Derek Chalmers

Yes. Joe that take is going to one.

Joe Stauffer

not dialysis in peritoneal are looking at The trials. any are our we of Yes. patients that

take not again, to oral who as Right focused patients dialysis them. on be are So are be are drug really patients will future. would what only certainly kidney would or either patients then chronic speculate they appropriate in an of for are types dialysis. that the who we But now Obviously, that on they they yet are use. to disease peritoneal outpatient can if an and medication, we able

Michael Jung

you. Thank Okay.

Operator

time, to further no queue. am call for would Dr. closing to like remarks. I the questions back in turn this showing Chalmers I At And

Derek Chalmers

and you work participate the Thank the to Okay. Liz I thank their hard continue and programs, everybody patients Cara of most our support like also the for today's our would various for trials. our you participating to investigators thank who continued in in importantly call. progress to team

good So Thank you. very thank you everybody evening. and have a

Mani Mohindru

you. Thank

Operator

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

You may now Everyone great disconnect. have a day.

Cara Therapeutics (CARA) 15 Mar 182017 Q4 Earnings call transcript