CARA - Earnings call transcript Q4 2019

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Operator

Good afternoon and welcome to Cara Therapeutics Fourth Quarter and Full Year 2019 Financial Results 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 Cara Team. proceed. Please

Jack Hildick-Smith

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

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

call that we the that results expected the regarding forward-looking the trials, the begin, the expected Securities first timing concerning candidates today's ongoing let of of made product therapeutic future Before the these are timing cash the meaning milestones in within Examples include the alternative Act for of XXXX. from including NDA, Private reach. areas matters company's development candidates potential trials, the clinical you not statements clinical investigated the statements line of facts company's remind of the submission historical Litigation the for and time ongoing company's and are Reform statements regulatory product readouts statements of for on me to forward-looking of company's be the its company's projected potential data

only which Commission. they today's All that on occur to were date furnished or in Securities events more that Cara after recent as Commission and such circumstances reflect and the and forward-looking speak of they Annual undertakes in to statements are were Securities Therapeutics or described obligation Risk subject made. of exist made statements statements. which no Cara to most actual other Because the expressed such differ the Form the statements Therapeutics' with Exchange to uncertainties, with Exchange or fully Report and from date forward-looking XX-K Factors may are company's on call Risks those risks filings the its filed materially subsequently results update implied including made. such documents on section by the

President and this Accounting. Participating on over call Makara, Rick Mr. I'll are and to of the Dr. and VP CEO; turn call now Chalmers, Cara’s Derek Chalmers. Dr. Head

Derek Chalmers

Thank a of XXXX and and for advance everybody significant pruritic joining productive call populations. certainly Cara KORSUVA you, development range was afternoon, candidate thanks the us on clinical very today. as of year the clinical Jack. Good across our lead late-stage a we for

associated The of with hemodialysis trial last X May in were topline full from we of injection of severe KALM-X of November the In year, moderate from positive pivotal patients announced results this last in in CKD-aP. Medicine results pruritus KORSUVA or England kidney disease trial to year. our chronic Phase Journal New published

of program of following patients strength In pruritus X ranging identified last non-hemodialysis trial Phase in a KORSUVA topline positive Phase to into in year, December forward the associated patient bring X oral we registrational population. from CKD with results tablet appropriate dose this our

those Phase XXXX. We atopic of in our also middle with disease And into X new oral need indications KORSUVA trials chronic high unmet associated two we initiated of pruritus. liver development program dermatitis clinical pruritic and expanded both the

corporate Lastly, advances with in of million. $XXX offering we we strengthened important public a made our follow-on financial position approximately XXXX

formulation KORSUVA in rights entered oral indication. for commercial also with a commercialize Technology and BioPharma agreement to We into Enteris its license oral develop to any Peptelligence

expect advancements expect provide we for And Building rest multiple the regulatory call, clinical this each of XXXX. data update and major an year. what readouts in and our we on the programs on this momentum from of XXXX I'll on

which this on Before other in which in been as is into news pruritogen MKX modalities we a mechanism specific as anti-pruritic of focus one to antagonist those that broad the quick dive programs such KORSUVA's have on blocking action, contrast week. reminder

blocks fibers a the cells from The principally release directly C range molecules action fibers, of pruritogens nerve pruritogens. stimulation of sensitizing of diminishes sensory of the KORSUVA downstream of KORSUVA dermal and action immune the on epidermal and the dermal of

And for activity kidney initiating that's or the dermatological we disease, of provides this chronic liver antipruritic neuronal anti-inflammatory pathophysiology condition. whether and believe regardless type effect has that disease, some of chronic dual

global two trials. Okay, in efficacy so pivotal in lead the a open-label expect our safety trial positive studies second which program topline read includes associated we four and data which efficacy of let's Phase pruritus. a program with topline patients last for we KALM-X, begin data CKD U.S. X year. with injection KORSUVA hemodialysis year This from this quarter our trial KALM-X,

worse or in NRS XX% And the with was placebo The clinical safety secondary trial compared robust group. a generally met itch intensity over observed subjects at also of KORSUVA the met reducing achieving KORSUVA XX% we subjects significantly well-tolerated least a of prior profile consistent endpoint, treatment KALM-X, in period. to in improvement with effect antipruritic trials. with endpoints. addition three-month itch the all of sustained three-point In primary KORSUVA injection intensity a

per times KALM-X, KALM-X Like trial scheduled sessions over dialysis period. of of placebo to after a per the KORSUVA designed week X.X ongoing investigate versus dose and efficacy kilo treatment micrograms at is this was injection global our the administered XX-week three

original to pre-specified the increase last independent maintain monitoring the on announced target October year, of XXX an to In from data endpoint. based patients, the primary conservative our of increase XX% enrollment we power about target KALM-X committee the XXX in recommendation statistical for a for

for second December topline the in year. was in and this last data level injection in by this from KALM-X of the enrolled we KORSUVA application to the trial submission first year our half of quarter fully followed drug expect second of this new

exposures line of of submission six more with ICH completing we in have X,XXX treatment. patients with over total terms XXX database exposures, safety guidelines a of patients patient with for treatment safety XXX completing one than over continuous currently NDA year and In months

U.S. Foundation moderate dialysis to U.S. over or in know high Europe. the Kidney are from in associated unmet patients Per pruritus is the some pruritus, in reporting need of area the the XX% severe currently As to XX% calls, level CKD range. therapies patients National no XXX,XXX of an with approved these XX% you with these of there

significant a unmet clearly So, need.

clinics We to in we the in us And European EU, commercial we've markets license patients Fresenius also of the momentum and established Fresenius in Japan, help of believe have the allows and leverage collaboration of agreement nephrology-focused do upon profit established across U.S. collaboration commercialize positions where Vifor with to us Fresenius and we've injection Union. to intend for including well this country. the expect success In a expertise South commercial Fresenius, launch. with a the the allows we U.S. major other Korea, for build this That reach commercial we to within injection dialysis the agreements KORSUVA the Fresenius broad in utilize which specifically adoption co-promotion sharing us Europe. Vifor and KORSUVA

of positive in and So, for NDA second established manufacturing. pending as medical have at Cara affairs, we where already half we've results, to this advance groups year pre-commercial our filing the CMC also functional commercial, scale including commercial an we initiated agreement key KALM-X KORSUVA a injection activities across supply

looking KALM-X Near and of of results to our approach So, update NDA that's and we much term, KORSUVA in beyond. course, of preparations you commercial Phase very we'll injection to months. the continue in X forward the we're we as where next on filing development stand terms couple

receiving CKD start currently U.S. on in our with pipeline of with oral KORSUVA severe about to lead XX% on diagnosed people the pre-dialysis moderate move and focused pruritus. X.X prescription with drug are the let's on programs patients for CKD in pruritus. data some our approximately pruritus-related of program treatment So to Based million sort here

neither of pruritus These the treatments burden corticosteroids, typically which or effectively antihistamines include long-term. generic alleviate

So again patient this is with large significant unmet a population need.

trial, safety oral our efficacy X.XX once X-tablet and of reported we year, the strands KORSUVA topline In X Phase X.X evaluating results milligrams, December daily. X last of from and of milligram positive XX-week

strength X of patients take data level with pleased Based a X. KORSUVA with in KORSUVA. meaningful into we observed clinically oral dose the responses forward oral on to we identified we're treated as the And tablet Phase the milligram

daily in at itch the XX. mean Patients statistically of worse this achieved reduction scores intensity treated endpoint with significant weekly week dose of the primary the a

In terms scores to of the of this improvement and intensity placebo observed and XX% missing a the baseline or on patients we milligram from dose XX% the achieved compared also patients of worse statistical significance. itch of barely weakening X responder was analysis, X-point in greater

of Looking treatment. of at a exhibiting worst the or proportion NRS higher patients itch week is zero values of one threshold complete level, responder final this the in

X All three significant patients placebo tablets a dose-dependent complete exhibiting improvements on statistically level with strengths milligram XX% placebo. of over response XX% approximately the versus at KORSUVA of exhibited

was our of profile earlier with seen KORSUVA and well with clinical trials. KORSUVA course generally oral a in that safety Lastly consistent tolerated importantly,

Phase X Phase second forward for plan the identified year. a to end initiation successfully program we this having of FDA meeting of an table the So, to in this X with the to of pivotal take enable hold indication, the strength half

initiated for both also see additional we of XXXX, trials Phase aim trials two data cholangitis of pruritus We to patient from atopic these in topline or biliary and dermatitis In PBC. primary populations, later in XXXX. the X do treatment

of expanded design power period. assessment targeted number to approximately trial after approximately And X treatment designated patient with of we from the again year, atopic be severe in XX-week conditional we an January XXX. this moderate XX% interim and pruritus include incorporated patients adult In Phase XXX dermatitis conducted our to to patients to the completely

we rates, for expect Based trial, of and size complete year. sample subjects twice analysis X do this statistical In trial the versus our of terms strengths X-tablet X.XX, enrollment this to the randomized of ongoing design, this were X.X milligram on that daily taken to placebo. in KORSUVA oral interim second quarter current and in

end weekly of primary period worst endpoint NRS the treatment of itch baseline quality of week itch baseline endpoints of well efficacy at -- the daily from at baseline the and least change as score patients life include scores each an from secondary XX. as week proportion change of mean XX of XX achieving is improvement X-points the of the at and The from the related and

the in year our at Cara. foundation ahead XXXX very laid overall, progress So a significant for has

expect the pivotal with starting clinical this is NDA to KALM-X Phase the half next going X second We filing from in of milestones year year. of important the quarter of data in several course our topline trial, ahead, and regulatory our which in first enable

these coming So we to on look in progress programs all you the quarters. forward do across all updating the

financial the also turn to call cover year. I'll and the that, with for the the Rick for full over to results And quarter

Rick Makara

Derek. Thanks,

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

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

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

with XXXX XXXX and our sale XXXX compound in and in related also included clinical from $XX,XXX Revenues were to Vifor of respectively license the Revenues Fresenius. to and XXXX primarily Maruishi. agreement $XXX,XXX

compensation the year In recognized costs XXXX, higher expense, in $XX.X agreement related clinical we were XXXX ended $X.X quarter to to million with compared revenue XXXX same Enteris $X.X XX, $XXX.X XXXX. collaboration Vifor Fresenius in to in million net fourth were development expense trial compared for stock increases of The the expenses XXXX. XXXX. as the agreement principally Research in expense connection the due to license during the well quarter in increases and of costs, payroll December as million and R&D million in in related

compared associated trials expenses clinical a of expense million reported $XX.X payroll in we and same increases related as as higher cost For increase the in period quarter, XXXX principally the The net due million well in R&D R&D to were fourth costs. in of $XX.X XXXX. to with

year accounting were was offset G&A XX, consultant stock million increases expenses primarily the partially due XXXX. and costs, to increase compared in December by to utilities. and and expense, fees, decreased $XX.X increases taxes. Those in insurance costs, payroll and XXXX franchise costs for The were ended related compensation rent million legal $XX.X

the million compared were G&A same the for million $X.X the was consistent at XXXX. of full balance to of relatively was average XXXX. was year portfolio expenses $X.X investments of due million both fourth The XXXX. $X.X during the XXXX our of in $X to million XXXX. and Other of Other compared in in higher quarter million increase income period in to quarter XXXX primarily income $X.X fourth XXXX

and end million the $XXX.X common of $XXX.X cash cash $X.X securities exercise raised July XX, at million As equivalents of of resulted activities. stock million in in partially options, $XXX.X December cash from used the from our XXXX by million totaled XXXX. our The of XXXX, stock $XXX.X compared of offset and primarily of received offering operating cash, million in to marketable follow-in the increase

to Based on be expectations, the timing projected current and Turning XXXX plans existing our securities fund for will operations milestone potential any and that December our sufficient for guidance. the of our development into under cash, of cash accounting clinical financial not to equivalents second XXXX collaborations. we costs our marketable XX, half expect payments as

turn operator Q&A. for now back I'll the the to call over

Operator

Thank comes of Chris question from Howerton Instructions] first Jefferies. you. Our line [Operator the with

open. is line Your

Chris Howerton

course, quite the And Excellent. congratulations last year. questions. taking of Thanks year for on a

a just of questions, think to pipeline. primarily the related couple I Derek, me for So

to results with terms the get hope they the So What FDA? you are the CKD what CKD, and do alignment in are. of program oral

you you think the community primary that about, be received best of and kind reaction? the more thought the endpoint, either investment have And will any would by ultimate what clinician get

Derek Chalmers

that. thanks. were one Chris Or -- you long you Okay, question? one was have do an going that thought question. additional question, Was I have to

Chris Howerton

like one know. to talk, question. I That as long myself you was hear

Derek Chalmers

mellifluous Yeah. as Yeah. well. tones, like I It's those --

with on study so. a endpoint. the you that And forward. primary dose CKD to the was did designed optimal know We take identify we our pleased had oral, So, as were we to strengths It data.

our endpoint analysis, in a CKD. definition, on patient know, And terms in this, long you terms time of end-stage spent we as essentially of hemodialysis

that our the that in at we for FDA, meaningfulness, consultation clinical took And designation KORSUVA, looked in reduction we score as the itch in discuss with actually for empirically breakthrough we looked patient of of data. when terms at actually class. And NRS

know is with for X-points. you reduction certainly as And to up meaningful CKD went enough a scores. number that patient a FDA X-points. plans little with that nice less we And our is than that And NRS clinically were

CKD So, endpoint oral forward, going primary that the with would as a be our proposal, study.

you Now endpoints. have as also, we of secondary range in interested there. a know, We're

analysis a the empirically look -- And But of with X-point at, there. responder threshold our other there we as would perhaps determined, have the far we higher does clinical as the responder, again, is fleet. meaningfulness and FDA consultation most likely, ways part threshold in for in analysis

Chris Howerton

Sure.

guess, be with would and But what outside on during so that the of not words you -- then, I'm your alignment And gain there think, out? putting -- perhaps, I'm primary the to in are like endpoint mouth. Or that I FDA, what need what you other worked things to -- meeting? are the

Derek Chalmers

the the You've be for endpoint. patients again, a based registration And proposal right, Chris. We our our had on would our CKD responder. analysis on nail head won on agreement X-point

Chris Howerton

Yeah.

Derek Chalmers

quality likely at, measures. would goal, well look most our life the that's And of X-point we that usual beyond main …. And as as

Chris Howerton

Okay.

Derek Chalmers

the FDA. of …at least, in meeting with portion clinical of the II, our Phase end

Chris Howerton

has oral of respect further Got you perhaps you terms And it, response. how given program CKD control in any of been to the okay. other -- there with in discussion placebo topic thought Have that, additional is expect the trials? to higher-than-expected,

Derek Chalmers

have. Yes, we

More one we've You'll be have surprised thought hear Chris, not thought that. to that we than sure. occasion, about about

So examine me of III. obtain, outright. this to and II to trial -- in to let we say, population aim but patient of be Phase want the able Phase course empirical The data is

proposed to the to patient use past based overcome endpoint response. is our power on based our this actually think, III placebo experience an on appropriately, Phase in anomalous even And unusual that we population data which

say. the first that's to So thing

if still the have an have our appropriately. placebo power the that mark, appropriately trial. we reduce data off measures we in that now can even are response, to powered we trial proposed We that And

fond we're interim make larger in as know, you of sure we're And on running, track to analysis very our trials.

So overall approach. is our that

to we're So that's a like going solve to how problem. it you this if view as

response we help, But do we in the other again, was should a we of we thought there placebo III we've that this, we about into terms believe, that this mentioned Phase some And our before certainly in have believe. adopt elements, could we patients. in KORSUVA for sales hemodialysis expectation the clinical previously sites trials A that used had sites trial KORSUVA use, for oral lot in the injection patients. potential bias, participated, these of were

with that experience But with the stage experience drug. the if patient previous that you novo end a could have So like particular formulation, the albeit the was in And is, certainly, haven't for that there to we're drug in possibility. a there different population. solution been de sites somewhat obvious the use had going

So we that's easily one thing adopt. can

run that is stage labile run may a We're the patients they wax we possible using more so more incorporated. than a wane perhaps pruritus longer patients end-stage predications which also in It's and consistent looking earlier little possibility period. at incorporate can easily have and of more period, identify these longer a CKD the that in to

the X:X then very Phase And reduce finally, by used one Phase dose looking versus randomization alone we response designed the should X of placebo the one-to-one from randomization optimum nature that that in on design trial. placebo the of X at

going So design. our of have certainly to that part as we're

we those we'll that the elements to we have we've do So confirm that data all change do can we'll trial. so. we interim And now that desire maintained power we there the Again then the easy should are with sure ultimately run we help make and trial power that analysis placebo. when

Chris Howerton

Right.

will maybe was increasing I to a quick sense So for minute, And trial? one for rationale phone would guess question of the make dermatitis me. be my I there what the atopic but think size cut that just out the

Derek Chalmers

we trial, end know course as of any endpoints. was of see and KORSUVA we didn't last we've really maintaining difference. discussed just pruritus that with year endpoint model the we -- at the statistical And in a did oral to powering power just that to And primary started high make it sure when data level appropriate the based Again with And oral CKD-aP analysis. we based of a have could data Yeah. And on achieve made increase to related rates, placebo the hand, based we size we power. on that for we sample a patients. KORSUVA decided that, assumptions some sense have in to on

an we sure power increased to were analysis size, we that track again. on with interim incorporated the again just make also And sample conditional

to AD. do two really complete next analysis that's well and interim is And recruiting adaptations new for expect the that So very trial quarter. we

Chris Howerton

Okay. but people queue back I a it. other hop Well, give I I’ll you. chance. some appreciate in have the to questions, more Thank

Derek Chalmers

Thank you, Chris.

Operator

Thank you.

Our from comes next line Amsellem Sandler. David question of the of Piper

Your line is open.

David Amsellem

Thanks.

Derek have may Can medications? but to use the your thoughts X just of could Phase you CKD number would study talk for regarding be medications And addressed So, on this, of wanted down And the I context Phase are backgrounds about you which which learn inclusion part you more in the what and the from background oral KORSUVA criteria, drill detail. of and be medications? what the excluded? background did one. That's X in

And partner? broader what own? would is own? And to Thanks. to that you And what extent Phase point, call that with obviously on that your That's have the on And a bigger two a question you'd dermatitis. ahead data different is different to then picture do that a plow the X you just in you look atopic would you partner? something is look a something CKD, Or will. your question positive beyond I that commercialize to is in vertical number guess would you if physician look

Derek Chalmers

Great. Thanks, David.

II patients. hemodialysis mentioned background So, looked at our we'd think have there what we've we Phase the before between there on -- and first the was did patients in look those seen difference patients. in CKD the trial And pre-dialysis question meds for I some we this

possible variables using than of acting percentage doesn't seem higher our as have it But we or patients pregablin. population Most and a patient doesn't to it's we're in with That gabapentin which that to most in as that antihistamines, eliminate try their to interfere such much patients drugs easily as these is that likely if design. But may help heavily optimized forward, leave the them Phase eliminate with data small we recruitment likely tends however. a we skewed So would. relatively X because sleep. centrally going can we percentage relatively

would we there. So that's what do

also a of that's a atopic In large course, derm, of different point standpoint. terms yeah, it's ultimately from population, and commercial a co

are derm. in capable atopic we think a I trial perfectly running of late-stage

require you handle so the some personnel company, spent likely can level and commercially that point time most at that It's the beyond development we As that experienced trial. that recruiting true know, partner some derm. registration would into it's effort could a we basically as larger running to with look designed But that do atopic know late-stage easily to what here, we'd we trials I we're you and late-stage partner. particular David, accommodate trial is and a think that indication

David Amsellem

the apply disease would as the there? a the I study, may you explore but And late-stage as Okay. would imagine to Derek well partnership logic run liver setting

Derek Chalmers

think Yes. and Yes. this on to you I And had have just previously. think I call I reiterate and this discussion

strategy we're of the like label ultimate if are formulation strategy, a the Our various course to and broad oral one, in lead pathophysiologies there you pruritus. that is of is for terms following here of KORSUVA

they mechanism activity have separate have the this these we is that patient like ultimately. if broad populations like to earlier a evidence about different and should you talked in see and definitive as if And looking you mechanism pathophysiologies. we're And That applicability.

run at it's we're so in we'd patient programs registration And population, looking every here. unlikely

discussion selective of a all to on that be patient But pruritus. populations forward. for we take the getting this useful will related we to broader to is data have We severe label when first moderate ultimately be going

David Amsellem

Okay. That's great. Thank you.

Derek Chalmers

Thanks, David.

Operator

you. Thank

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

Your line is open.

Annabel Samimy

And for of my like taking word, questions. I use can your I the those expectations. mellifluous. I up Thanks hope live to Hi.

going in population? a gate Do placebo hopefully AD that is the that at and placebo of tell variable a consulted minute. you So, much you're us, the for it's population a still physicians guess, see you or with less you've to feel just response that point going this consultants. as not of I Can back -- to number

and CKD you -- did the whatever… upsize IDSM, to population? upsize IDSMV necessary something did placebo if to the calculated that's Or it it to have it or by when interim ID, then of assumptions the assume XXX when you your you analysis? you just set Or is at Second, a trial brought amount the beyond

Derek Chalmers

IDMC, yes.

Annabel Samimy

that their specific at IDMC …right, on calculations. moment based

more. So first question. I that's my couple a long-winded have

Derek Chalmers

a Yeah. that's question. great No,

in of population looking there. terms data in lot placebo, so AD a at there's And of out

As particularly from different you looking terms pruritus. endpoint, know in a but drug lot classes looking at disease alterations of also of at

a And of so there's available information. lot

Those factors look we in that a about see at when were had at within we we power look really that and and we maintain high CKD-aP relate trial. to So the at sample the and see what terms would the variability thought our two effect. the at statistical to oral specific normal we rates a of then looking size placebo treatment looked be

And it. how that's we modeled

in with certain modeled on oral that to based we've in as placebo and seen we'd the treatment you the So effects a population the like it if well as was rates extent seen historical had there. seen atopic been variability

that So paying of of placebo increased essentially. idea an the was possibility accommodate the response emphasize to

a statistical difference. size in interim complete. the to XX% sample that maintain And, see you going power on our can our assumptions And you're we IDMC of alter correct, when conservative confirm we was then we're again, power level assessment right introduced make conditional we sure you're again, to have actually what to like can those patients recommendation, if based the

We're in analysis be NRS responder We're this going with looking not particular and at looking trial change. at to also also mean that. interested only

had So sample that if whole data upsizing of oral for was that historical generated there you like, That We the we really kind the basis of with data rationale. in size KORSUVA. with atopic. conjunction versus, was

Annabel Samimy

sufficiently the secondary endpoint understand significance on to atopic I now if statistical correctly, And you powered Okay. for are dermatitis. see

Derek Chalmers

the Well, that -- endpoint not completing of maintain advice some IDMC, on I the that are have we're to XX% see well. well as patients And power we our aim of as treatment again, we on secondary a wouldn't will have is from response say, when point the sufficient you out, -- period. the analysis that to that's

Annabel Samimy

Okay. And about trial. curious then the just PBC

didn't You that upsize one.

one something different trial? that treating that you are there So Is differently? about

Derek Chalmers

we disease. a again, before liver discussed see this think Well, I truly trial and as we've for that proof-of-concept

PBC indication the in to the patient where, know, orphan you more beyond U.S. is expanding and As in to fact, to that. recruit gather quite this population point, U.K. an that’s patients the difficult at for

want see a patients populations. back we to hope be label to we I KORSUVA get there that's And to signal, more there oral getting ultimately broader going that's much in can the a a we to challenging that data for with make sure but So see to enough of supportive gets had David, discussion pruritus.

Annabel Samimy

Great. right. Okay. All Thank you.

Derek Chalmers

Annabel. Thanks,

Operator

you. Thank

question line Gerberry next Your comes the from of America. of Jason with Bank

Your line open. is

Chi Meng Fong

CKD. Hi. Good question on Chi This piggyback earlier for is, is oral first with guess, everyone. evening, afternoon, question good your FDA about the Phase alignment I to Jason. end of II for meeting

Just curious, Derek.

the to of hundred, Given thousand IV formulation patients not CKD. exposed there if are have several

safety a with the whether IV thoughts after maybe safety And from amount on a that Phase wealthy whether on database already? smaller already Thank I or for database, on could be or then, additional III, trial follow-up the the have potential there to of be you. Curious alignment run have you be smaller given conversation that. dose FDA could a

Derek Chalmers

oral patient Chi. I we CKD, our also and higher that do Yes, KORSUVA We Yes. formulation. think, here previously thousand with Thanks, that been for exposures thought out, several like, you CKD. obtained we've discussed IV than a have, oral at end-stage as level you that Actually, with exposure if possibility tablet point in has patients. our in

for a III CKD So program think do to oral it's and reference as be we case of pre-dialysis we our able that should reasonable Phase those part patients. safety exposures

we for I particular a but in forward when a and the that It's certainly FDA, Again, about for and FDA propose reduced as And as result program. could our we'll reasonable that. a something can't something that interactions. guarantee of as Of path we thought may registration trials course, number decision ultimately that's we upside, investigate we think it's indicate you an that perhaps, there. that have

Chi Meng Fong

trial AD also and sites the said I for based CKD are you see the available for on you that effect the response the CKD And AD. I'm your wasn't subject it. on modeling based Are clarify -- own sure sorry, in or trial. can expanding about I rates, maybe, on placebo the not? you other you for the size When the Got data response trial into numbers that. if the taking historical on account

I So a factor confirm increase. the the whether you. size that is whether factor just to trial into on want Thank --

Derek Chalmers

we rates likely achieved We're looking at with oral, much had historical and looking Chi. Thanks, in these patients at for much stage AD that placebo early treatment the completely than CKD. effect populations condition their it's and much, atopic realize are have the we Yes. patient more different we're predominantly population CKD longer but

do with sample seen increasing So we the CKD, response placebo with can benefit the was but in there. models. we And different than treatment in from incorporate into what the size in we of effect, those basis see that's with we've rates expect we AD combination the AD population for that again oral something expect the

Chi Meng Fong

versus any we last about should year? I if year quick maybe a ask guidance provide you can follow-up, incremental color think or if And it. you. Got can burn how Thank this on

Derek Chalmers

And it's to that? through guide a discussing. of from to Rick, burn we position on half cash all carry you quarterly you overall, year. The been know this this that's be Rick quarter-to-quarter, second programs, Well, expect do to do through to we Yes. and as out executing add as and the year going we've into us lumpy the pointed anything our don't XXXX obviously want

Rick Makara

be expected No, with Yeah. in it I trial level mean than would of activity, be in XXXX. the will that XXXX it was higher I higher it think

Derek Chalmers

and X file then trials of the the our As second NDA half we Chi Phase the in year. complete

Chi Meng Fong

so much. you Thank

Derek Chalmers

Thanks, Chi.

Operator

you. Thank

comes from next with line Cantor of Duncan Charles question the Our Fitzgerald.

is open. Your line

Pete Stavropoulos

Hi. This on on is Charles. Pete for Stavropoulos Congratulations XXXX.

the KORSUVA, for any particular Oral are or So medication patients atopic dupilumab? study, medication including excluding or you dermatitis on refractory to any including a particular

Derek Chalmers

Yes their we watching Well, patients are. that hi, have Pete. medications. all We're

medications. come to going they're no into clean So that trial

Pete Stavropoulos

new patients when from? the geography KALM-X I in sample mean grab for was you And size Okay. the there among all any or particular significance statistical increase to Or the dispersed order maintain it centers? that powering. not the study, Is you

Derek Chalmers

in indeed increase it almost majority those is of KALM-X the sites. the increase sites, additional patients we And approximately clinical patients are from in all of there. patients when Most U.S. sample XX%. came about vast U.S. fact from size those in of XX% the all sample Well,

Pete Stavropoulos

And between how the sites the and clinical of many study actually overlap Okay. the second study? first

Derek Chalmers

Virtually none, in KALM-X. than so those were separate from KALM-X

Pete Stavropoulos

you congratulations Thank on again right. and the quarter. All

Derek Chalmers

Thanks, Great. Pete.

Operator

Thank you.

question Alan next of & comes line Carr from Needman Our Compnay. with the

is line Your open.

Unidentified Analyst

X. Maybe or can on AD Joe help question. us expectations taking Hi. response A improvements maybe results Thanks quick the This one in is Alan. around you Phase for our rates potentially frame on coming for NRS.

best of there's your X You mentioned, as view in injectable number of what a comparison there. two would and some even terms data in Phase comparators? one But out oral be or

Derek Chalmers

this of approach it's the Yeah. hard prior data Thanks, is non-selective, Joe. if like I mean, that this using than used are There's really are medications company not as with a because to we up being you other lot you that there. only comparator, a come with know modality. investigating

to and have a standard appropriate main for as you be here. we So there adjusted reasons so responder know, again Phase more used in much that's dose-ranging as that's primary sample sensitive and the an dose. conditions at And mean NRS the that looking done will the we was that responder it's analysis all Xs that have And a we is X-point of reason derm analysis. what but we're X-point trial. at in Again, FDA that is our identify analysis as trial, continuous our a and one the size a variable looking secondary consistently likes

Unidentified Analyst

Thanks. Great.

Derek Chalmers

Thanks, Joe.

Operator

you. Thank

the Canaccord. comes with Arlinda of question next Lee from line Our

open. is line Your

Ben Shim

And Many Ben on my guys. Arlinda. for It's of questions answered. been maybe just have one Shim to thing. I'd Hi like ask

As this could the And a just are we provide going will Maybe milestones year? by straight for they us be potentially on filing may any detail get and to of for they more closer be then for Thanks. or way little the and you cadence to special ultimately magnitude earn data pruritus. accounted you revenue? in that from to upcoming bit

Derek Chalmers

Great. Ben. Thanks,

In total and regulatory commercial. the of guided that terms the and dated before I in think specifically, amount four of we've terms milestones and there with

regulatory milestones will $XX that via that million there arrangement. So, particular is to be coming in us

to quarter. as guided actually haven't We particular

that's part We agreement. expect to Ben. of that milestones license see that these But the is of level

out given file Pharma. when and of $XXX go will any we But we in reiterate is we excluding we and projected milestones guidance R&D, the the on approval, NDA CKD another that, to Rick we expect commercial sales milestones all in as Vifor us guide and to the there's the Beyond launch But financial and terms and million through west Fresenius runway we've U.S. visibility Maruishi forward milestones. more have said line then time again or here from those for

Ben Shim

year to good Okay, keep Well, luck work. the another and congrats great you. on up great. Good

Derek Chalmers

Ben. Thanks, Great.

Operator

Thank you.

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

open. line Your is

Esther Hong

Hi. I've got questions. two

the sample a for of end interim size then and regarding And increase statistical it's the follow-up. required? lower one So, atopic range next if analysis I've quarter what's the got first the in dermatitis, upper

Derek Chalmers

for Thanks Hi, that. Esther.

One for So, haven't we what dose can ability going we the number. range Again, towards to the we're actually And sample we a of that increase most size. be us to upper the if that guide that curve. at have a divested that, dose-ranging would thing say an also on look at like directed is see. I to is We'll patient active specific this you the trial. a IDMC publicly will

what haven't that as point. the to we're at So, that's in. limit this upper interested we most of be got it would But actually what

Esther Hong

that on any any leave Will to on follow-up how rollout KALM-X KORSUVA? closer my as then us And to to your potentially is data additional launched. Fresenius so details launch you Can Okay. Vifor plans Fresenius, Fresenius Thanks. you details? get clinics we initially of focus together strategy, remind

Derek Chalmers

give confidential detail Yes. Esther. Unfortunately, this I can't that. point much at on That's you

course working of are coordinate We with to Vifor that. Fresenius

see We strategic here pruritus. have KOL activities We've associated CKD We're that hard the opportunities CME of this year. appropriate MSL We've whole established increase And KORSUVA to publication we sponsoring regional our an education national range the to really that including established symposia preparation expanding meetings. working of launch advisory awareness to universe for our going across trying footprint boards. undertaken at and Cara. throughout increase real at we're you're and pre-commercial a team company. We're broaden are and activities

in we And level later people then will hiring in access and market of be course, in side, sales some on our XXXX. commercial senior marketing

So, there you is as here an coordinating integrated in cross-functional plan Vifor in to co-promotion specifically the place and Fresenius also with indicate relation to in accommodate a arrangement U.S. our launch we're

Esther Hong

Okay. you. Thank

Derek Chalmers

Esther. Thanks,

Operator

turn Q&A like would the closing for over remarks. I to and our Chalmers Ladies you. gentlemen, call Derek session. now that Thank to concludes

Derek Chalmers

participate to real Yes, call hard-working thank patients year. to much you like you Cara study our trials. the continue to the throughout team, I'd looking who everybody for also and our clinical very forward participating we're And on in updating our all today. thank the and soon investigators

you Have thank So, much. very great a night.

Operator

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

You may day. now have wonderful disconnect. Everyone a

Cara Therapeutics (CARA) 27 Feb 202019 Q4 Earnings call transcript