CARA - Earnings call transcript Q4 2021

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Operator

Good afternoon. My name is Andrew, and I will be your conference facilitator. I would like to welcome everyone to the Cara Therapeutics Fourth Quarter 2021 Financial Results and Update Conference Call. All lines have been placed on mute to avoid any background noise. After the speakers' remarks, there will be a question-and-answer session. Instructions]. [Operator that being advised call this be recorded. is Please introduce Interim Therapeutics. Head would now Investor Francesconi, to like Cara I of Iris Relations from Ms. Framcesconi, call. you your may begin

Iris Francesconi

Thank good you, Andrew, and afternoon.

detailing today, the for quarter at be and The a market found financial XXXX. fourth we year release after progress and closed press Just www.caratherapeutics.com. release press our full on corporate results website issued can our

in to today's of Reilly, listen and also Executive a call Participating call the Medical Chief the may and Chief of Goncalves, live Joana Posner, You replay Cara's Chris section on Investors website. and Officer; Cara's today's are webcast Cara's Officer. Chief President Financial Tom Officer;

future the you the Examples of the and the and commercial for we Reform furnished of section Cara such forward-looking future Securities products to in exist the implied or Cara facts forward-looking injection, from the company's the today's and obligation and company's of on statements the from XXXX. subject injection, factors impact may of reimbursement milestones statements on most expressed launch, these products call are company's contained risk documents or of including company's regulatory to and filings potential the product statements reach potential areas made development be commercialize no candidates to trials, the uncertainties, and on the forward-looking were data such performance regarding Because statements, Commission. Exchange are Private maintain company's clinical with of risks described timing of Therapeutics regulatory they include for Act within over planned -- alternatives the ongoing ongoing COVID-XX expected which subsequently filed the KORSUVA submissions, statements undertakes looking of future the the not recent events trials, made. company's Before will XX-K in timing With this, timelines candidates, adequate to to therapeutic that remind those results Commission, Pharma, statements. successfully company's Vifor timing All ability with today's differ cash forward in of call over the statements circumstances approvals, only of and Securities meaning expected were report on to investigated, the clinical it on regulatory the more our turn the the they are fully of that Securities the clinical Chris. historical and materially let KORSUVA to after ability enrollment and planned statements speak initiation, by partners readouts company's results potential Form which plans. Risks development to in other its begin, annual Litigation Therapeutics' occur made. and commercial date or of including including and that date matters I and coverage, to the concerning me call launch, the Exchange that regulatory are potential such turn actual update recent as

Christopher Posner

listened our Today, our Thanks, tremendous our a after on will available that, Tom our Reilly, and our of delivering the Tom milestones, days Officer; me the Dr. lead join everyone. call Iris, Therapeutics. provide as and afternoon, I my necessary Injection. preparations our Cara, commitments, you Financial confident here KORSUVA the Medical Chief review of continue conference am CEO make we on Joe today and quick good deliver of growing. things first Chief we take learned to your I a first now. financial starts ingredients goals With Officer. have Gonsalves, update. and you to and build XXX it will have launch to are in very Then we today I progress In are And for first platform ability long-term that I against give I doing at Cara this growth some earnings excited questions. then our be our and my follow product, to to am with trust quarterly updates sure to plans. role, to in build will will a

against in the place, ahead right focused very and executing strategy our have We work our is on strategy.

a problem wide the strategy and our a is pruritus. currently lack in This category-defining pruritus quality diseases, drives a this it mission actions. leader underserved of the and chronic even treatment it for intractable options, remains of by guiding building are significant used of range have though our negative can millions on of in of patients. treatments. We of life patients often severe, In impact pruritus underreported, Chronic light is

so patients to most the committed novel are for that We care this and benefits enhancing improving of possible. protocols science the patient disease the our treatment awareness

Over executing the past on strategic priorities. made year, progress X we excellent

defining our severe to undergoing NDA had to Our for in commercial team only XXXX, is Cara. FDA priority and treatment swiftly for than data in FDA-approved disease chronic the more moderate With X,XXX pruritus patients adult optimize the KORSUVA priority we submitted hemodialysis. In kidney first the pivotal at review. patients, In the of a first moment injection. KORSUVA August, to potential injection became

moderate has we patients chronic Injection Vifor will diligently kidney to market KORSUVA pruritus as the the a with this Pharma This for new to Pharma important Vifor granted prepare in Now disease. an is of severe license U.S. market exclusive recall, been commercialize readily working addressable product. associated hemodialysis U.S. you with to XXX,XXX

in granted status injection TDAPA addition, reimbursement CMS December. In KORSUVA

current KORSUVA U.S., will Outside in we on a more also for significant Now launch I provide see opportunities moment. the preparations the detail Injection.

our to European CHMP second We opinion MAA Medicines positive a on of in on expect the based year last the quarter decision Agency this make the week.

partner, our Pharmaceuticals ex milestone announced recently partner, U.S. Fresenius In Renal III Phase from positive approval an Medical reminder, payment study Japan, a EMA million to a $XX Care As entitles us Vifor results. Maruishi our cash Pharma.

kidney second strategic not disease, KORSUVA priority to platform in our dialysis dermatitis. advanced Our and III for requiring oral is Phase chronic pruritus into advance atopic programs

Phase Following meetings we programs. the with pivotal a with forward end X these FDA, path II have clear of

to will more initiate trials hope I both all join. III expect upcoming There details these can Day Phase month. be XX, at trials our on March which We this in indications R&D on virtual you

chronic therapeutic Our separation third its we a Because indications. In paresthetica inform strategic Phase liver other see in placebo notalgia priority novel respective including of pipeline forward with utility these proof-of-concept spectrum In oral of potential treating notalgia across be a broad a expect primary in from mechanism chronic oral of readouts in our we expect XXXX, is trials studies the disease. diseases. KORSUVA to data we cholangitis. the clinical to These expand of endpoints. KORSUVA and in areas, pruritus will the information to action, in us path see biliary II trials, at to with provide important paresthetica from both critically and product,

to for launch. we I'd execution the and of like provide prepared are KORSUVA early injection, preparation upcoming we into more the are April and and insight the Now of excited launch impending

efforts. in and leading who First Together, partner be Pharma, terrific we right partnership. Vifor have we commercialization foremost, have a the will

key makes concerning steering committee the commercialization a and launch decisions efforts. all that have joint We

an and as as and the company nephrology hopefully commercial array of is relationships prelaunch force launch These start Vifor well efficiency joint a cross-functional fast with to The been us focus launch achieve with Three whom from hit venture. of and Our leading large speed. have with support a will the prelaunch X with organizations, has and they of the ground running particularly partnership and reach trajectory. on sales the activities. key pillars the Vifor that, a one injection. top has To day dialysis frequency long-standing steepen team activities first gives completed allow us a our prescribers work. KORSUVA Fresenius the to commercialization

the for is field approximately fourth year Vifor on last XXX sales since This sales trained First, patients and deploying education for state been a of conducting force is quarter to representatives. has the force engaged pruritus of entire and an prepare advanced launch. the the including begin could first Vifor the this once quarter market with injection has disease in hemodialysis. sales prospective quickly professionals, of effort of to who identify providers, care physicians, therapy been is available. the range engaging KORSUVA force patients Throughout practice nurses year, team health

completed In representatives in and live PI trained package sales on insert their ongoing to the be also care trained these Representatives ready providers. addition, been at go. health March. and using have currently campaign in on materials are meetings they materials the with All promotional will discussions are

formulary vial will centers, we're this the X. list for about with or market Vifor's we market. the helps April price the On pricing, with year. nature is at Recall, X and engaged formularies. significant confident to Second, team of overall. and on really On KORSUVA XX% J-Word the product total on of $XXX $XX,XXX code injection large launch the TDAPA We injection fully the that important discussions the dialysis injection of per set has for and team reimbursement, patient made have effective per are actively account commercial WACC KORSUVA reimbursement, or a per access. roughly access, On pricing, represent this KORSUVA expect be in and dialysis The top available consolidated dialysis all be process centers. organizations progress

product to drive the robust preparing is pillar third of a The supply launch.

KORSUVA injection product of launch. and center the note is awaiting One wholesalers the already on the have distribution final and sufficient We launch manufactured centers. dialysis shipment quantities at to

injection in new did companies months Pruritus is a track. we an a strategy. As In diseases of first-in-class not to value. through feedback In an anchor development options. product, to many the we conclusion, need want see on right on clinical health bring important validation that as creating indicator a significantly do, the XXXX, drug road providers across its to but identify solid and and care patients therapy. launch underserved in what as a the Positive and from anecdotal and our we we novel are early mission our and is recent managed significant approval have symptom step treatment many KORSUVA are

progress made KORSUVA We building also our significant platform. oral have in

we XXXX for transformational see as Looking ahead, a year Cara.

execution priorities focus deliver that will on Our gives confidence we strategic us our and on our objectives.

hemodialysis. approved commercial is potential on of our to optimize Injection. Vifor, the for to partner, pruritus launch priority first plan the only Through KORSUVA we patients first and product The

ready for availability force to field with product reimbursement are roll all in the pricing place. and launch the We and

in pivotal III programs are pruritus advanced we with advancing our platform oral Phase and Second, in kidney KORSUVA X disease atopic dermatitis. for

initiating We our the these of Day. upcoming and in month, more R&D are process this detail to we programs in are excited both depth programs at

forward expanding with Phase to disease in interacting potential areas, therapeutic coming chronic of build to KORSUVA look of as of are leader the clinical characterize the product pruritus. we oral and including months care liver all II the in chronic over the with paresthetica other pipeline. Third, readouts we you utility our notalgia I further into

quarter over you, to who to CFO, detail. Now over I'd fourth Over like go will our end of it and year our to results hand in Tom, Tom.

Thomas Reilly

you, Thank Chris.

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

earned and revenue For $X.X the to fourth $X.XX equity during million in XX, recognized XXXX were decreases the the million with to payroll compared expenses million higher $X.X Vifor. related General basic the agreement $XX.X the December period XXXX by fourth diluted CEO $XX.X in million period and R&D license to in per which the principally compared milestones $X in same we million related injection quarter million Enteris The XXXX stock-based the includes loss of $XXX.X million to we a associated of per clinical we of of a fourth of diluted XXXX. in million during and basic to The in in $XX.X in and increases offset our the same $X.X compensation $X.X XXXX, of administrative and the XXXX million in incremental decrease XXXX to $X.X million agreement quarter principally $X.XX share and XXXX. costs period XXXX. months reported of of recognized related ended of supply of to $XXX.X XXXX. our the development XXXX, KORSUVA expenses net partially with revenue of XXXX, $X.X related million to costs, the XXXX. were with same of or due were $XX.X sales license for the quarter million G&A In period Vifor modification In of QX November per commercial X compared fourth expenses were awards same XXXX, to Research to of net to was expense, by period lower compared in or in same million million XXXX. during trials in VFMCRP. $X.XX QX expenses quarter of compared the expense $XX.X income due former share to

In legal in decrease quarter addition, insurance costs, $X.X fees, Other income of the an commercial period costs XXXX expenses. the consulting and million XXXX. to income decrease to increase compared yield in and same of period. $X.X fourth the The partially payroll in by other primarily interest a investments costs, a in in offset XXXX on in million was income decrease due from in a our portfolio resulting was of lower

related January related Pharma related diluted million $X.X of Phase the and year Maruishi revenue $X.X the pruritus in by $XX.X results. share December million to uremic Full to injection December or Now first Pharma license purchase. year XX, We earned equity of XXXX, to ended the $XX indication III $XX net reported million per Vifor. loss and from of paid Vifor a for income Vifor for to of recognized supply we XXXX. to compared to $X.XX -- agreement was turning $XX trial year commercial million million and related of basic from diluted $X.X to per VFMCRP, sales In XXXX $X basic for net a million million XXXX, the with in our XX, ended the $X.XX full we compared as to share KORSUVA for premium or XXXX, the million the XXXX million XXXX. Revenue $XXX.X financial initiation

with development XX, full $XX.X December million related the For includes for a the payroll and recognized were agreement XXXX, as XXXX, the the period year ended expense December year compared to were Vifor XXXX, an million compensation $XXX.X and ended expenses in XXXX, same XX to to Research equity license for to stock-based million we the in primarily year December to during XXXX agreement related $XX.X principally due with million $X for incremental full due related former by and costs. stock-based to license December a year of million compared year year earned increase $X.X stock-based ended The the XX, of costs, million million the million XXXX. The decrease milestones increase expenses compensation R&D December million XXXX. expenses full and compared $XXX.X $XX to ended a during lower the XX, in an modification compensation ended XX, in trial partially full by offset XXXX in $XX.X were awards in XXXX. was our to increase Enteris ended VFMCRP. General expense in administrative which for $XX.X CEO's clinical in November

XX, primarily addition, $X.X commercial million ended legal December In offset costs, and insurance year million compared XXXX, year to and partially in full resulting balance for period. increase in payroll interest the on The yield costs from in decrease consultants' costs, XX, decreases XXXX. was of average costs. a fees, the income a portfolio was $X.X in our investments Other the ended full by the decrease due December to lower lower XXXX of income, for

offset revenue Vifor resulted million As in from approval compared recognized KORSUVA cash marketable XXXX. balance The by of $XXX.X upon which which million injection, the securities operating of $XX of was payments equivalents, million used FDA on received partially milestone in $XX.X activities, December to VFMCRP, the and QX. is from million as of and decrease of $XX our in XXXX, totaled cash, XX, December million XX, cash $XXX.X

potential sufficient back to With to product clinical of through and Chris. I our our receipt operations cash and we not XX, or development under expectations, Now plans fund guidance. will projected the costs our cash, of over existing as financial current now XXXX, any collaborations. on call securities the for that milestone be equivalents, timing for payments revenue marketable will that, accounting turn expect turning our Based to XXXX, December

Christopher Posner

in Tom. to growth years we believe drive immediate are will the growth and preparations come. Thanks, that significant help summary, we executing In drive

elements X fueling have growth We core engine, Injection. KORSUVA our

product is prepared. launch other We KORSUVA for our of the are to on our partner, potential on first kind U.S. U.S. We April. and a product its the in countries. disease injection executing in are and focused eventually patients first in pruritus the of hemodialysis, treatment the and chronic EU of its Vifor, we ready are kidney maximize in and

pipeline. Second, our R&D

our and advance take platform KORSUVA across to pruritus. continue to has pipeline a potential pipeline, a steps which disciplined product be the spectrum we to a We oral of think

including market on new focused the deliver leader this into starting have financial this this growth with drive patients. The will our turning get launch anchor to us we to the our population KORSUVA reality, stronger patient foundation are commercial bringing to treatments our strong partnership Phase help And profitable the foundation in underserved be opportunity of underrealized exciting the programs strategy make potential to of strategy. is Vifor X economics month. pruritus, product, an on of and We That even III pipeline injection our of there. to millions

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

for now questions. So the Andrew, can you up open call

Operator

[Operator Instructions].

question of & with first Company. comes Stringer from Our Joseph Needham line the

Joseph Stringer

comp about. experience. that we be on your higher come are to you key Parsabiv launch drug just of think And to launch mind? there, and thoughts what differences. compare any a go from to you relative could get Amgen's I some Chris, given contrast could would that -- if types similarities could or a that KORSUVA but somewhat of wondering curious was how certainly that of I'd in some comps other sort particular be level some your One expectations think comps of

Christopher Posner

you. Thanks, Joe. to Great hear from

preface and upcoming I'll talk by And and launch think about of different about product ways. saying I it's -- think the first a launch in couple to let I So about a first this launch. incredibly exciting that how only me

a patients in population and of care the Benadryl Word overlooked it's I my about It's First, And by significant, world. Again, lack by as underreported very typically total patients. we treatments. standards of XXX,XXX mentioned are the significant addressable is physicians. a of prepared significant remarks, condition. the And see much the

overall kind to market think I it's dynamics, reimbursement. incredibly think could of of the about, about the conducive as launch. overall dynamics So first, a strong launch One

code, reimbursement, we'll have X,XXX the right a in we Fresenius very to and And which all infrastructure. partner, an most It's about have the mentioned, the concentrated you DaVita physician terms of force We J a Word audience XX% company, is have and ready very roll of nephrology be April. in and accounting as and to TDAPA and they now I lastly, we goes with a and down leading nephrologists. concentrated have have dialysis audience of organizations for dialysis established where with roughly patients. execution, important strong sales It's Vifor,

Joe, point adoption. So a the you terms to success, in if strong think drivers very they about those, of for

The at Parsabiv. after a look product of second and as that not And the the during TDAPA great we around mentioned good analog question Amgen the period, comps period. was TDAPA but part probably your you probably analog a

that, It $XXX year in with TDAPA the the second Parsabiv uptake. $XXX, year. what first million during believe, year and the strong XXXX, we period, So close very to third in saw had, I is the

brand TDAPA differences. Sensipar. That ever billion as in at with TDAPA competition, period that obviously, net feel, Sensipar we generic the only into lot will after a that competition. be oral product second about again, went of called $X.X as go well no the And equivalent the one. We'll a total that Joe Post-TDAPA, of a through cumulative had had there's sales. So was

the incredibly net-net, So our value of fundamentals proposition strong. remains again,

would dynamics a competition but in lack also the launch value very, the launch and unmet the I success conclude market So the by very be needs and will support given of very fact space. strong the a remaining maintained that saying trajectory, proposition with sustained strong the

Operator

line the Chris comes our And of next with from Howerton question Jefferies.

Kambiz Yazdi

launch for is in and look for what you a is anticipate the reason April? TDAPA the as there metrics the for expecting launch? the IV And KORSUVA then -- question, any And on in do maybe like? Chris. the Are you there impacting pent-up decision implementation how lag December any COVD-XX demand between Kambiz a was Team, launch? This does second performance

Thomas Reilly

let Chris, last me the take one.

first terms in the So said, of the lag. the what last -- you one

it's TDAPA when So period. in we receive XX-day a December, implementation

the has implementation CMS X. at the So April

So that was the CMS was fully that expected. via

the last that's So part question. of your

around what market pent-up metrics for and we asked approval for believe great is agree with part this an shaping. we've last The and them demand. The getting August seen to you thing what strong Vifor I first success, preparation period around a

that target out So really the X, to as months the they well education for on the well as doing Vifor last X,XXX nurses X organization. dialysis awareness, disease been focused has as as talking proper the nephrologists

So product with to shaping that's again, going and We for shaping with strong -- beginning proper months. market the April. disease the in feel it's all be, the again, awareness, launch very X underway a last really been

Operator

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

Nicholas Rubino

Nick on Annabel. is Rubino This for

If and commercial follow-up, I maybe just could. then you if a

launch down the the of just positive EU, what the cause some expect to to to post-TDAPA there's Kapruvia still benefit, we then of expect Kind we contribution with Fresenius more kind CHMP which congrats of And opinion. charge, there? So a the should on pricing? inflections reimbursement tackling. shifting to like? but reimbursement is before when on lower period, look paradigm should likely volume bundle kind leading come level is should definitely But of through big the Obviously, and the blocking drill

Christopher Posner

question. the for Thanks Nick. Thanks,

So post question is TDAPA. the first

remain think we TADAP. injection KORSUVA look think the post if how is will there will strongly is be because proposition this funded post you I competition at be the will we think mean, properly Again, competition, very the bundle, no in TDAPA. strong it So value that very about we coming. but it of

as on only therapy. and really more and as we patients that be we go the So through first will will get strengthen

TADAP secured. well, we're post very will be -- optimistic think we that funding again, So

terms about the and the in no very patients of additionally, in it's XXX,XXX the think proposition The value EU, If EU the roughly on in U.S., EU. opportunity in to moderate -- about size, we we roughly really there's in the a the obviously patient hemodialysis in experience again, the about large I lot. EU. we think country. second about a there's question same products XX% patients depending hemodialysis are approved to treat severe about There think CKD of And important, pruritus the talk pruritus patients on

there be significant between So it's the still clearly some very differences may pricing EU and the a U.S., but opportunity.

Nicholas Rubino

And oral Congrats expansion. on real then X, Stage quick. just to KORSUVA switching the X

can you you're Stage if be give assumptions going wondering you it's that now for arm thinking of the how Just us to it's X know kind about powering and that placebo X did you or more IV before II more about with X? Phase the at that the help looking Stages X study of to KORSUVA you think to you study inclusion. Are

Christopher Posner

let Yes. turn Nick, to me that Joe. over

Joana Goncalves

give we'll about be As at more III details Phase week, that and to next R&D and lot conducting know, can a going sharing our we're Day the be more designs you stage.

Operator

next line comes Kulkarni the Your of Sumant with from Canaccord. question

Sumant Kulkarni

have couple. I a

we very rate I peak in any? discounting then or XX,XXX be On TDAPA follow-up. have share period? a what the that set, of the can modest real-world you've the addressable list, price And might utilization a if And assume

Christopher Posner

from Hey, Sumant, to hear you. great

you typically would D. of in terms in bill contract, but Part price, see the significant I in as it's mean, the and space, is some buy contracting not certainly So there as on

about excited we're to for if I treatments anecdotally approved reinforce guiding look treatment. a what So very just -- second proposition, so sales from always really like. there I would what hearing of of contracting. There this you that the But that again, lack early question share. it's And adoption the -- product. early point, the at this tell assess of will and and around But Yes, burden kind second no real keen significant we're your can question, I forecast. product. to dialysis pruritus. of in what was the disease not peak we're some are Sumant, interest think, this organizations be we're And not is value you this is physicians your

thinking for you So kind adoption of strong And had a very follow-up. believe, a that's I Sumant, how curve we're Injection. about KORSUVA second

Sumant Kulkarni

Yes, oral that relatively one more it pipeline based own itch atopic read remains given KORSUVA or of challenging indication assume MP paresthetica your through the a data more KORSUVA target? to And set notalgia expect Is to it's might in how learn fair upcoming dermatitis, to that thing. base pivoted we in programs example? you in anything for the pruritus should dynamic, from

Christopher Posner

Yes.

Let to me turn Joe. that

Joana Goncalves

paresthetica no to manage. So options approved because treatment is difficult of There very challenging itch a and indeed, notalgia and XX currently are quite treatments.

are we So second excited the to quarter in study, data year our forward readout about our and look this I of

Operator

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

Christopher Posner

Hey, your Jason, I in you're I think coming out, and don't know, of connection.

Chi Zhang

This is Chi for Jason. Can you now? hear me

Christopher Posner

Yes, perfectly. go can you hear I ahead.

Chi Zhang

Phase readout. the readout? upcoming about respective question disease. from Can expectation talk guess for first looking I data have you had know said on you I separation is II how So the [indiscernible] for placebo at I expecting

for the are they the II endpoint is studies? looking a respective signal-seeking study, for looking I I you when curious, exercise change from are baseline So Phase for guess and look each primary at a this I'm you're separation? Or looking the score. results where And at for numeric

like how a similar to sort So I'm you into on of guess prior I to guess interpret X the from from be what in dialysis similar the of based responder curious, score I setting? changed on responder can endpoint? the expect And indications these and has registrational endpoint risk extrapolate investors And rates similar we the should the to potential either improvement either X data any also line CKD CKD? point, that or like as point on it Word to ultimately baseline, only could in expect the top registrational be reuse for if analysis sort would

Christopher Posner

sure. Sure,

could Chi, let she Joe me by one. me to address those and questions one Let -- that turn

Joana Goncalves

Sure.

me So first let question as regarding address your first proof-of-concept are a our these studies Indeed, reminder. expectation.

looking are numerical separation from placebo. we for So

assessing when looking other outcome and study. we Additionally, we'll the data have the endpoints, you be -- entirety its at additional of the in

know, as far regulatory precedent. there notalgia no you As is paresthetica, as endpoints,

that the division. will the this through the what The division. a agency. would regulatory through discussion the end GI discussion the on So points will goes be And again, goes GI with that And a be be. term with PBC division

Chi Zhang

IV second I on question guess my KORSUVA. is

of I there before. guidance least latest what's you KORSUVA, -- this now. the at process estimates right But curious your revenue will XXXX you for Company year, commented in don't have Cara. how contribution if -- guidance think any IV to thought on providing think the XXXX you is for any had for consensus on comfortable management sort on And provide do is

when it's but it, out revenue million, a what look of it's and I think little to sales like whatnot. sort what's piece bit hard and around product is I $XX at contribution

So it there and Difficulty]. I'll we how stop [Technical see

Christopher Posner

it's no, No, good good it's a question. question. No, yes. Yes, a

our Let me CFO, talk guidance, Tom, to turf to that cetera. about et

Thomas Reilly

position in we're So any not now, right guidance. sales provide to a

As Chris profile, are confident our market mentioned the Vifor. in product given concentrated the before, we with and partner strong

work the a on at upcoming guidance Vifor We'll we over to discussions, we quarters. at appropriate time. based Inject will So KORSUVA the have appropriate those with rapid give the uptake. And believe continue time will

Chi Zhang

more question one And for guess just me. I

that with compared rate. into management Just thought where the contrast the a commentary after classified in were a of post-TDAPA bundle I been curious follow-up as such especially antihistamines the be imagine how I'm counterpart, and existing bundled already you to there's be TDAPA But there's color setting And so it like category. each up KORSUVA on category the I each appreciate as there's an period, Certainly, your Parsabiv, Benadryl consideration would generic bundle the with would already process similarly adjustment. sort go to that if provided, Parsabiv of sort post-TDAPA. to in

antihistamine relatively and been while. So a around cost is it's low

should thinking what's bundle the thinking So -- bundle how factor how you curious alternative, with I'm rate? it might each into about the category rate adjustment? existing how just the low-cost management that classifying and the Are into process differences about

Christopher Posner

next we're will I the to mentioned mean, So to TDAPA injection over given as optimistic funding the I after incredibly KORSUVA post-TDAPA, be before, expires cover X years. X additional that

available. there'll it Jason, -- will So very -- again, that we funding be we're confident be

we functional You there's confident, patients. pruritus that FDA with FDA-approved are no Well, in category, there's we for no There why therapies why approved are why, is question the hemodialysis mentioned are in Now the pruritus antihistamines. the therapies. category optimistic?

KORSUVA that will believe at funding we additional don't for injection. be So antihistamines as look included the they

I to we them, Again, proposition. it it It's also think And but population. limitations. thing limited the in that's know down patient for has significant have value there antihistamines efficacy important. very goes the only really certainly really this

them. used But continue mean, I net-net, signaled us, for and the and during appropriate we'll CMS. us this the talk is TDAPA is I importance think is to by to the great. which talk work and Vifor willingness So possible. as many again, is drug They've continue we'll accessible to sure post-TDAPA, with patients to to with make as period

Operator

of the Wolle comes next Daniel question our And line with from JPMorgan.

Daniel Wolle

pruritus of by including underreporting mentioned You by one hemodialysis of factors, as the patients physicians. overlooking

campaigns? through sort there's some So those to treatment any of to aware options if DTC possibly that plans see to get trying I'm of they're so patients

Christopher Posner

an critical, commercialization Having critical is a the lever and absolutely. XXX%. informed Daniel, Vifor in patient Cara, for plan activated and base

mentioned work it's lot treatments. mean I with hemodialysis Vifor. among of pruritus we've underreported no done because I undertreated it's in As patients, a patients why before, and there's

So really we Vifor the is very base. lever pull with will marketing activating heavily patient the that

Daniel Wolle

it financially Or Okay. will for you then, be solely? type of Vifor And that responsible marketing? be will

Christopher Posner

organization up here at No, we any don't commercial Cara. stand

the will costs. the responsible and for commercialization Vifor be subsequent So

Daniel Wolle

to And a bit color get then paresthetica. for on the opportunity just little notalgia

many to the have such million treatment outlined are to patient this how as severe a by be You've And addressable patients. have KORSUVA? potentially around patients, moderate in presentations, prior X those opportunity those Of pruritus?

Christopher Posner

Yes.

and it to tackle me a let color commentary. for maybe little then turn Joe I'll So first

pruritus. million for that there's are patients we receiving X medicines think antipruritic about So

a doing by these how before, would that's In think addressable And main of patients. be terms Daniel, you us, are work what you actually we still folks we're I be that that I -- many hear use call frank. the it it is we concern among to I the use. back you and itch, is treatment the is, primary of quite And can't what scratches scratch. spoke see would

the it's but about unmet oral would I space. it's again, be the in want do we see the from population And need how Joe quarter, and burden significant know, in to approved to think therapies KORSUVA. we're a think very very, patients. got excited Joe, of we say... So always a you says next data there's that I don't this Again, there. looks no addressable these on significant disease an

Joana Goncalves

waiting have that, without possibly. could to patient add to to that our to who [indiscernible] population that reported an X that -- again, well moderate potentially Just serve publication I so would you data, gives And indication think, last have at in drug severe do itch. look a year's but these these patients it patients who about

Operator

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

David Amsellem

So, a have just couple.

gabapentin the terms about First, CKD, which KORSUVA. mix other I for just X is itch study then be can't talk can but point for just IV NRS -- point to other the of just secondly, that's the between how X for figure R&D it landscape should till not can endpoint. getting, you talk how -- the Stage you on And question. in about How out just And to day, X about wait of through we or the talk X but to a IV Stage patients or fine, want antihistamine, you worst that? And oral extent agents, it's say, the systemics, think X say, play asked will ahead Joe, should that's the and I commercial CKD in I this the then going go study? and whether it's a the be, through to buckets, between breakdown going lastly, question if KORSUVA,

Christopher Posner

patients some primary terms you but you get of predominantly some the that maybe hemodialysis the the and small the effects. antihistamine, gabapentin. side mean of typically tackle moderate one percentage as antihistamines patients very to have push I is comes a around baggage among that steroids, treatment have know, treatment, I'll predominantly topical to you with in dose there, it's in mentioned severe algorithm pruritus, first gabapentin. So And

and we very few. saw our X, even patients and few very X studies, in So come in on gabapentin

we the slot So these nicely of for That's as patients. to standard in we it. we're think how going very view care

In question I'll your turn terms Joe. CKD, second to that of around

Joana Goncalves

those for wait will to if that's further next case. details give week we the But

little you detail. more ask and patient, a the describe be studies we'll bit Phase in to we III So

Operator

I'm showing no further questions.

call for back over So any with and President Chris that, the to CEO, Posner, further I'll remarks. turn

Christopher Posner

Well, XXXX are I into to of focused Vifor, lot, we an for and for leading commercialization, are our programs next when We for starts our the Cara. the our us our joining of ready everyone going execution. III virtual March our take R&D will thanks With injection. thanks And progress level. heading details a the joined partner, we you event Joe is leading year say what Andrew, to taking on the year of KOLs. deep this future and be today some efficient, launch dive say a I'd on Phase really pipeline XX KORSUVA about hope to for to us with now Cara. a great hear for like we to successful

that, So call thank I'll with and everyone. conclude the

Operator

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

Cara Therapeutics (CARA) 2 Mar 222021 Q4 Earnings call transcript