CARA - Earnings call 4 2023 | Cara Therapeutics, Inc.

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Operator

Thank you for standing by, and welcome to Cara Therapeutics Fourth Quarter and Full Year 2023 Earnings Conference Call. [Operator Instructions]

I would now like to hand the call over to Matt Murphy, Manager of Investor Relations. Please go ahead.

Matthew Murphy

Thank you, operator, and good afternoon. Cara operating news quarter results year today, company's announcing and closed XXXX. and financial for market issued release a the full After the fourth section be this in release of website can Copies the caratherapeutics.com. news Investors of our at found

the remind various the let for and the being these be results including of based forth or will XX, to and factors, its and Form update XX-K future that during certain to on Securities ended our expectations. program forward-looking as risk are in statements XXXX. Private management's Before for reports this me undertakes results developments. the under Cara's risks Act call, plans quarter conference December ended SEC, may new These Reform or any obligation we with Investors statements of made September should due information subsequent subject you factors statements materially filed or are begin, the and set read revise and and current we a XXXX, XX, making Cara Actual course no Litigation year uncertainties. publicly about differ Cara result XX-Q of XXXX to the

I'd to said, Officer. Chris? the to call over Posner, that With like Cara's turn Chris Chief Executive

Christopher Posner

Officer. diteliceplin and focus. with oral for highest that have program we Chief Matt. to success, We afternoon, the Officer; Medical Dr. in Financial . or in NP. developments our year today and you Chief this and Ryan clinical for thank are of prioritized sharpen joining announced Consolvas, XXXX Thanks, Manor, notalgeparastetica Good Cara's Significant me our call. strategy led January and With Joanna us our of likelihood the commercial

condition value cash milestones neuropathic resources our extends a NP a all and no this allows which all sizable Focusing therapies. us approved highly population in program. to underserved reach with is patient runway into NP inflection our XXXX, on

become and such could is address clinical oral if NP. that late-stage to has difelikefalin our are therapy for and neuropathy, relatively is how often optimistic want upper difelikefalin, the changes I pruritic by potential antipyretic Notalgia yet condition pruritus only detail it. first can NP We leading approved, oral NP of program common. oral unexplored the of and as why characterized The neuropathic highlight chronic to excessive back, paresthetica is result a a scratching. pigment disease an

anecdotal of chronic of has of we paresthetica bit, pruritus understudied. But I impacting in terms Notalgia while An neuropathic studied believe chronic X% as patients is pain adult population have chronic or dramatically neuropathic pain XX quality evidence and in will has or the of has and as approximately onerous been suffer targeted as highlight that pruritus, pruritus. U.S. $X.X been not. pruritus million XX% And neuropathic of estimated chronic life chronic and the suggests a extensively, from often patients. chronic million them

a a those neuropathic Notalgia predominantly of are patients patients XX% or care under XXX,XXX out Now provider, the of care dermatologist. pruritus chronic health paresthetica

helpful. wide-ranging patients is paresthetica as and Notalgia patients, suggest yet not significant account many their this health life has impact from and the This NP been mostly treatment pain miss they treatments patients. patients been often feedback the a not of with sleep undiagnosed research, at the for debilitating topical has treatments And or challenge had of activities. of frequently it. that are no for is quality current number mood, does self-care constant for pruritus to on no that significant or on address almost Anecdotal offered significant or including as efforts side their therapies ineffective responded In systemic all treatments NP XX% minimally neuropathic use and are indicated approved Notalgia had that effects. associated or There off-label market pain. and paresthetica for other of

stated clear unmet literature a As therapy well-tolerated almost treatment they not currently for of an effective, that on NP. It for NP. there need were the for and any is responders and from significant that our safe a XX% is result, market research

data and statistically could program DSK lead in oral presents at proof-of-concept the In a DFK's way BID and worst approach oral We XXXX, has It showed patients. these neuropathic significant from thought showed early Our to itch the pruritus. as Journal Phase mg chronic investigators The lot day paresthetica's a study chronic as the leaders, neuromodulatory publication attracted neuropathic treatment Notalgia address separation X sustained DSK period. also NRS scale pruritus. England throughout oral NP, February New target double-blind our action X-week from placebo ideal dose mechanistic X. an Medicine a believe of II in treating efficacy of hallmark on the of to attention

I completed have rapid am line that has to Highlighting of announce COURAGE in pleased and in to safety this our Part results unmet track dose-finding resulted the of we significant of in putting COURAGE enrollment I this A enrollment ahead top Phase II/III report need, excitement efficacy schedule, the study. on portion year. I in us ongoing QX

comparing program. and Courage the comprised pivotal of oral DSK X We plan study X placebo. dosage currently we active sites I and is parts. the additional Europe, to of reminder, XX Part a America the placebo-controlled is North dose-finding double-blind, sites portion a to include strengths in X-week of portion A, As the have study of for

of the Phase will open endpoint study wide dose size B therapeutic and NP COURAGE and a proportion greater to X oral DSK of the the II. the underserved potential readout than sample we a unmet KOLs the data, need III initiate worst dermatology patients Part Ahead to The I second be NRS indication. renowned the and the in of these week line with key this baseline of in panel Courage improvement top of X-point trial role program, and the this The hosting provide specifically will from in of pivotal portion the at scale. itch information primary is from portion discuss disease of

join We of us. will event this with issue you announcement days, hope the an coming will and details in we

quarter KORSUVA reflected to XXXX, This is to In fourth the strong growth in and providers. testament a quarter-to-quarter demand the and on patients XX% offers continued a saw clinics. clear by individual injection. value growth the Moving to clinical their vial demand as to ship of KORSUVA we benefit

with following that significantly protocols current However, of end TDAPA modify restrict on the anticipate and unfavorable access will we XX to this reimbursement treatment dialysis changes year, organizations the March DOs KORSUVA. period

result, forward. do not we going contributions KORSUVA from a As meaningful expect revenue

following months, swift reiterating X Let the we decisive and by me over the conclude have action. taken

I extended high on the by sharpening runway I optimistic and highest details that for success. has focus of with we and over commercial potential. breakout on the Ryan. and for our paresthetica stakeholders. all sustainable our our are evolved on to strategy Over create ingredients value our program have am the quarter meaningfully growth and to results. confident now to unlock clinical a probability right the cash for call turn potential Cara our the like with a fourth you, would path program We additional Notalgia Ryan to

Ryan Maynard

the our January nondilutive of us our prioritization in value announcement XXXX, thereby runway extend I transaction to This, with QX. reiterate Chris. like financing forward in value royalties ex the royalty, completed and us of of this our reach and all to milestones the bring Thank our we a U.S.A. healthcare We which combined meaningful first our to you, were balance Japan able importance manner. inflection program. allowed year to in in to into would add cash enabling sheet NP with

financial Now Maroshi other from In the statements. are under the I'd this to and our as as total QX, on our a HCR received Royalties sheet. how agreement in long-term balance recorded recorded we also like is reflected net our liability proceeds P&L. CSL noncash revenue on highlight agreement

noncash We also recorded interest. imputed

Xx received reminder, this if would back HCR then initial before a by and thereafter XXXX exceed payments the the royalties revert HCR's contribution to As us. then under royalty agreement

Now XXXX. And In HCR XX, of to reported of XXXX, for $X KORSUVA the results. of generated million. same our million Vifor sales compared for related X XXXX, to consisted on related months in $X.X other related payments revenue quarter period revenue of CSL to to collaborative injection. the of of net from agreement. the milestone injection December We ended sales fourth million million to $X revenue the the this million quarter and of Revenue $X.X royalties KORSUVA $X.X QX profit

translate were $X.X XX, the Cara. revenue partially clinics in compensation incremental our the X increases $X.X goods these for of in vials CSL was to to before. charges XXXX, the sold for from decrease were development continued ended the mainly in X to grow due of of wholesaler inventory 'XX of The rather of XXX,XXX Research into costs expense. primarily therefore, that to XX% quarter. to R&D higher actual Demand programs, for compared and trial quarter expenses stock-based period related months in a sold reaching did deals Cost development period for to shipped this to KORSUVA in shipments same XXXX, XXXX. $XX.X December same a and goods clinical network $XX X million was inventory in expenses million was XXXX. Cost vials the QX were months ended offset majority December late-stage not million XX, by million included adjustment vials than compared for The prior Fresenius within reallocated the with increase which

to the Cash, operating XXXX. XX, in ended XXXX, marketable cash period $X.X December ended $XX.X for $X.X used needed XX, offset at XXXX, agreement X $XX.X expectations are months were compared the primarily a decrease commitments longer million received December essentially proceeds to reduced last the no December the XX, million in demand $XXX.X million of KORSUVA expense flat in that The the for related totaled same G&A at and of included from R&D million in X to year. manufacturing expense equivalents balance in an million for by net expenses securities cash to HCR. resulted compared $X.X XXXX, X.X% from the of million months States. United activities, due the

cash, be XXXX. plan and available marketable to sufficient sale fund that for Now and our current anticipated securities finally, we into will operating our unrestricted expect equivalents currently cash

includes Our to planned of XXXX, pivotal current for in our operating plan reflects the our of costs prioritization impact which related announcement MP. program January

I'll turn it Now to back Chris.

Christopher Posner

unmet oral is the in address Notalgia on the need fundamentally trial II/III and sharing from we on in pioneer on data you look and the QX. focus Phase with the our of dose-finding paresthetica, Ryan. data, company. to path sharpening becoming dermatology. suited we preclinical a the Cara uniquely is underserved strategic a medical to the in DSK care portion this of highly to medical Thanks, field -- forward clinical set have disease. By Based development

and Now with Joe happy to I take questions. Ryan, be that, will your

Q&A. for line the open please can you operator, So

Operator

question Annabel first Our comes from Instructions] of the of [Operator line Stifel. Samimy

question Annabel. please, Your

Annabel Samimy

just just do you could think then that for for a the And in the mechanism. So you community the enrollment stages even for X you high late would attractive this partner and NP a that the doses a for you after you do the looks Phase rapid obviously, pretty clinical clearly, could dose development look when like you that And only from in couple think you think for rather about the pick III? or category separately, parapublication, you program pipeline given be optionality got How partner interest want patient? Would take want to to commercialization. for? to forward, would dose opportunity of this the large the

a know I that of that if you're those but getting expressions development you're -- just interest I'm I wondering interest, publications. company, realize that just from So given

Christopher Posner

Annabel. Thanks,

Let part quarter. your tackle to second part Joe, then the I'll me first the of turn and

Joana Goncalves

Annabel. Thanks, Yes.

program outcome to data account based will be will large address when A. the from just of size the take results study. for be. how Part into upon part together pivotal with We'll the the So being assessing results our This

that we more So to get data. come once

program. far how dose take ideally best it's doses, as always makes many forward. a As simpler It just X to pivotal

So that be will [indiscernible].

Christopher Posner

Annabel, Yes. your of on the question on partnering. second part

have And the -- this the of cash all the clinical prioritization given totally key early did great. programs. available which beginning the into year, in know, to complete unencumbered, the we 'XX strategic key this As we is is asset you

intend super So unmet the right enrollment England the spurred down excited the saw this interest we're now. to in we the mean, we large continue New rapid of Journal, believe, now, said, NP. by certainly is what indicative, Like physician development continue is our need by also we intent of path. the but you And I to

Annabel Samimy

or exploring I thought Okay. other just for option. it to right I -- could And was question once And now, with for any ever up follow if BID. it's was never there Is any scheduled know X this daily this [indiscernible]. Joe. an

Joana Goncalves

question, Yes, good Annabel.

And profile predominantly drug needed based with As the population. healthy on this you population patient for PK kidneys. daily is this excreted is is twice the the patient what by that know,

will it a remain . dose. BD as So

Operator

of Our Needham next Company. ahead, question of comes from Please Joseph the go line Joseph. & Stringer

Joseph Stringer

Just expectations on had at XX% trial Part on NP a and IIa think X-point I readout. you it placebo. endpoint, mg at few around for on the KORSUVA dose Phase was that analysis key XX% the the around -- efficacy response X, the A In the week for X responder

A? I and win A you And when guess, replicate Part what can bar is come confidence this the reasonable that what So data you consider success a Part you'd this a you what consider in out? for data gives

Christopher Posner

Joe. Yes.

Joana Goncalves

Yes. Thanks, Joey.

in different that randomization awareness X Journal keep our the pleased incredibly slightly active as arms got as sites we as steady design more the X New with have England placebo we now to to we're in the versus greater from So late We have study the X:X well, has comfort. that breakers. well data through mind do

little So higher the we anticipate than within seen. placebo what response likely range, a We bit still slightly the expect higher. maybe same but we've that

that, when has of profile. the take is is to really show into have all A the not see we see to placebo. with our that part most of for with expectations from to separation the have that aim we're It to do setting we doses into versus this separation one our this forward we been be Remember to able aiming favorable demonstrates benefit-risk account that significance able pivotal to hope So that select so powered our be to to and really, placebo, program. move statistical what dose

we see. to . what that's So hope

Operator

Our Jefferies. from next line question Dennis Ding comes the of of

please, Your Dennis. question

Unknown Analyst

QX. We questions on data can MP in X ask the

just exactly effect Were than be exclusion Or comments life made comment? seen upcoming criteria? a have You of changes placebo it frame Phase previous we higher around impact around us? you like it's your And doesn't getting expecting of to in better, Can two, any what that bit you earlier be II, quality the quality as life. on that help any little that And number measuring will then seems well the it including there data. really for have previously. to but drove in

Joana Goncalves

Yes.

design contribute elements A was mentioned, we Part comment to my what any the key -- as comfort. not is the same factors a my placebo much pretty higher placebo. comment So had randomization. for as due this There's and reiterate regarding a But that design in to program. The may I I'll just X:X

sites. So arm. different are on on what This when we before. study active a more X:X. larger is had It a they're may that That's feel they with to placebo steady patients was

have So awareness. more there naturally greater when course, is you then, sites And durability included. of the

that the So if you we into higher. will be slightly take are all anticipating account, placebo those factors response

regarding quality robust anyone your points from. of [indiscernible] the where end conducted second first what and -- trying randomized patient question life understand NP that still of time we're regarding to had impact on . And quality of most the came are we quality a life population. appropriate life that's then for comment study, So and

necessarily for are relevant from our that's And we that that data, used pivotal and that we're navigate still so And what tools to is. as continue what program. -- to are what our forward work move not that not that to understanding we through conditions, are necessarily we through dermatological II that's still -- other understood we NP. navigating and Phase The

Operator

of question comes [indiscernible] line Genuity. Canaccord of the from Our next Kyle

Unknown Analyst

Two [indiscernible] questions is Simon. This related. for

on is dose, granular readout -- planning guys happening are doses? potential on are the different the safety regarding you any highest are And Thanks. second safety of you're the details well? in then limitations expectations expecting? disclosing And on is as first question the [indiscernible] The what the what

Christopher Posner

A the first the with disclose will line to we're one, QX, results be yes, safety going that in Part Well, and top efficacy readout.

the efficacy top the to disclosing -- question we line turn So is to and your and safety second answer I'll you. be part, yes, will first it

Joana Goncalves

line statement present. Yes. typically And to top we what the with add just

most your So bands, adverse common discontinuation.

dose a similar it's saw It just regarding expectations. data. And COMFORT so the study very your as And And consistent that X-milligram typical in profile. safety the highest comfortable we twice of and then the would So throughout our second and highest programs was acceptable a of we there. NP, readout which was we with daily, remains anticipate very fact, in and the so question seen dose used very that what feel one. safety a we've with all with our AD with

doses. Of course, got X lower we've

expectation the doses. profile. want highest so But is dose that base the reiterate good lower be I very that may the to a And tolerability with the was

we if see so same, And with be very that. pleased the we'll

Operator

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

Your David? question please,

David Amsellem

might just oral out your DSK? other thinking Kind what development core with you how -- where to company. it resources be of gears for this being that perfect of to I in speak, mind, in an switch be potential issue? so have settings looking from And on thoughts to in NP wanted into you you anything And do a cash any to looking you a mining just is for, the think there comments early I and DSK, oral away are that that at weren't about bringing just the the world in might dig world then guess with about secondly, guess, stage general? being is of just anything runway in business [indiscernible] -- terms there beyond

Christopher Posner

[indiscernible] Yes. you. from Thanks, here David.

really is through I now prioritization disciplined and January our do things. other key our we what to to focus around on i.e., we're mean, part our that which And to So the resources was at milestones, Notalgia with able pruritus, cash fund of great. be paresthetica. first there. in a of succession neuropathic question your our are We want program looking goal is

-- that's our sole we're So focus now. right

again, mean strategy do You to value asked our focused So points have. the our [indiscernible], at cash we options make the more NP aligned And with potentially of certainly, could we -- do the due preserving I to add streamlined program leverage our value look we assets. of in our look to focus. program. us cash to question NP strategy gives right? inflection in we at sure we the the now, company right to organization execute That's course, the the have .

Operator

conference like Posner closing remarks. would now I Sir? to turn the Chris to back for

Christopher Posner

Yes. Thank you very that, much, wish call. I today, everyone I'll afternoon. close And and thanks us joining everyone, the for again, with a and great

Operator

today's for you may conference Thank and This call. concludes participating, disconnect. you now

Cara Therapeutics (CARA) 4 Mar 242023 Q4 Earnings call transcript