- Earnings call transcript Q3 2022

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Operator

Good afternoon. My name is Shannon, and I will be your conference facilitator. I would like to welcome everyone to the Cara Therapeutics Third Quarter 2022 Financial Results and Update Conference Call. [Operator Instructions]. I would now like to introduce Matt Murphy, Cara's Manager of Investor Relations. Mr. your begin may you call. Murphy,

Matthew Murphy

and Thank afternoon. you, operator, good

and Cara news the in release after news quarter market www.caratherapeutics.com. the the a today, close release this our of for Just Investors announcing section be website issued company's XXXX. Copies filings of SEC can of at found third results

and under they our made management's Litigation factors, materially Before we expectations. uncertainties. of to forward-looking conference under plans the we XX, XX, call update like XX-K XX-Q in Reform Act and about this making Chief subsequent to forth publicly. Cara these factors turn and the December statements September that certain no on Cara's you differ begin, like over statements for remind read Chris I and to are various These to being to quarter any ended statements call XXXX, risk and Private year Officer. programs of are I'd duty with should Investors Cara set and risks may to Cara's the Chris? will Posner, reports current the the With Securities would said, for the XXXX, various results course during and the ended is Actual XXXX, based Executive due SEC. that subject filed be the

Christopher Posner

everyone. good and Matt, afternoon, Thanks,

has about to was Cara, a pruritus our proposition. on to to where the to believe for world quarter years traction on propel growth value long-term us leader goal started third the strategy We The come. strong for has unique accelerated execution our in become road

across affecting disease solutions Our to clear potential areas. to focus this many underserved condition is millions provide

differentiating this strategic focus is momentum, gain we factor. a As

showed for injection place that pieces The Demand accelerating, success long-term near-term for of third is as KORSUVA our anticipated. strategy. in we and are quarter the

opportunity KORSUVA the advancing to world. difelikefalin pipeline launch in And internationally the quickly and the presents oral in and franchises of are nephrology We rapidly our expanding dermatology. Kapruvia build with sizable countries around

the demand third KORSUVA's were Cara's it Product towards significant quarter-to-quarter dialysis injection strong to jumped in value successful are launch KORSUVA appropriate We wholesalers forces. And injections with strong franchise. from result for from a clinics. the the sales the momentum injection the demand the is reflects and profit-sharing shipped Fresenius pleased It Net million. $X.X key CSL of and how builds is quarter. KORSUVA injection to vials revenue million. to was of a Vifor The a hundredfold for execution in XXX,XXX over KORSUVA progress acceleration for demand also continued field proposition patients. underlying $XX.X

outlined sustainable As demand. key dialysis the Fresenius. large the the demand third acceleration LDOs, the most from primarily long-term organizations of from we drivers quarter, are of come in And last did quarter,

in this order Fresenius all DaVita the reorder to the almost color, number end on which clinics similar space. prior clinics. placed extra Difficulty] understand all some expected more gradual, an momentum. closely monitoring and has there of we quarter, For positive by of rates Care launches been starts based product Medical in patient is we [Technical Nevertheless, the are

significant Facebook National providers penetration stakeholder than We CKD-associated keeps have dialysis half feedback pruritus conjunction medical continued which the conducted sheets, rolling ordered In infographics, the groups. of October, the includes is quarter, the the on Foundation comments of KORSUVA engagement. program testimonials and fact of page, progress market the we seeing Meeting. American acceleration encouraging Positive recently, at with and launched a of awareness programs Kidney Overall, a heels midsize CSL momentum second Nurses Patients, strong Meeting initiatives product including growth second pruritus driven of Nephrology at and the with we're anecdotal Association have awareness of Kidney DaVita across is CKD the CSL clinics more Vifor pruritus partner, that launched by XXXX new our Patients, This were the Vifor, Driving on of full Vifor caregivers, with third American early launch. and This the In in Fall product had a reorder. and launch, multiple KORSUVA presence any seen very who successful at quarter large market CSL Moreover, have Kidney patient event. injection. after essence the quarter. launch from the organizations Annual previously American see Society CSL a providers, significant Vifor this Live CKD-associated continued symposium benefit relayed American patients Fund patient high a campaign. clinical Association in rates. with in And solid Nephrology into the the and demand. our a the is targeting the all independent U.S. reorder web comprehensive and

the in this launch, we to injection demand the and its normalize are KORSUVA of Germany the shipments some variability in very with a strides the guidelines early still launch and to treatment clinical also significant the leading how Keeping chronic process. continent. potential disease. available launch progressing. the Kapruvia is Kapruvia started on option picture Internationally, has KORSUVA are with pruritus big We Cara first-line we Germany the continue the in the view, quarters its updated making quarterly has In kidney wholesaler over to expect pleased for it's way, has EU, coming in and in with include across rollout made globally. as

start positive this also We in has Kapruvia's the at launch. are with Austria. commenced pleased of launch development the

to EU countries majority expect We in of launch XXXX. the a

Kapruvia the in under Australia, Canada Singapore Pharmaceuticals KORSUVA expect recently partner months. XQ the the name announced Japan, in our with the approval PMDA. Now our in also Maruishi Switzerland, in for product we and last and country, and Consortium was approved filing Access In coming in approval

the in this half of second decision application a We XXXX. on expect

on our Moving pipeline. to

utility progress great are We priority expanding the difelikefalin. oral of making in strategic of our

in trial enrolling advanced Phase dermatitis. kidney III clinical associated with patients chronic We our disease pruritus ongoing atopic and in are

program the the the We exciting throughout onset second data X, of phase still III readout the top early CKD of half for of We sustained Phase the notalgia and data day XXXX. presented occurred late-breaker in to AD to presentation internal as for at additional oral action, half difelikefalin highlighted week line A active are in Congress in rapid continue XX. EADV which target in its extension as study of we on recently Part paresthetica. expect for second reporting and effect the the difelikefalin's The Milan of XXXX,

when to quarter in program the look in update the clinical steps providing with and trial to appropriate. an discuss on a this pivotal scheduled meeting a the have We NP, we program to FDA the future, forward

XX-week proof-of-concept pruritus our onto associated trial PBC. with Finally, in

interpretability Given of enrollment, The slow the patients data. limits a small the the the we strategic made decision continued unblind number discontinue data. and to study of the

in data efficacy was pursuing a is not indication right It However, do that preclude later important safety note and us direction, there trending from the the were to new no signals. this date. at

building our we of expanding at nephrology focusing and With this advancing time, are NP the a pivotal dermatology our our franchise on franchise. towards resources program, potential

continuing made date. therapeutic both have that has areas, build We opportunities quarter we believe we conclusion, significant we to In with in and momentum. shown this are to have are progress pleased we that

are nephrology drive This we create for world in growth We of long-term Product injection, for in Cara shareholders. pruritus quarter: laser-focused our traction we maximizing the evident this accelerating X and leader our to and value in and demand forward are for strategy are a difelikefalin rapidly was is potential moving KORSUVA gaining ways becoming dermatology. oral on

Now our and Chief for for all introduce that. third to with quarter you, provide results, to Financial we'll Ryan. I'd be Ryan quarterly our available on Maynard, call like questions new earnings his details will Ryan your Cara. after Officer, Over first

Ryan Maynard

amazing happy Cara's time Thank part be growth you, story. I'm this Chris. at very team a exciting to in this of

Now onto results. the QX

same CSL in supply for the the equivalents period sold milestone R&D parties the and the sale XXXX. related and related to Cara's KORSUVA XXXX in for our of were to a at to of resulted As million ended to in The injection months million commercial during G&A XXXX, expenses million to market of certain $X.X XX, financial XXXX. were to expenses support XXXX. X ended period operating injection. payments months million, period compared primarily to Cost million to to trial XXXX, increase to XXXX. Revenue XXXX, comparable and due the the due R&D The to same function the compared in $X.X to marketable X due related be and XX, today commercial September in this G&A million spend look shipments cash XX, the a in million months from balance in press increased $XX.X growth. the $XXX.X $XX.X our we the the activities. same quarter of supply the X release III with X to revenue months CSL XXXX, headcount-related third $X.X third $XX.X X of higher sharing decrease million $X XX, expenses payment cash Enteris. million the of the revenue. of collaboration clinical revenue results the of Vifor associated ended securities Revenue of expenses Phase million million totaled of X of at milestone in was KORSUVA September from September to September recognition $XX.X reminder, combination September programs compared primarily $XX.X months XX, XXXX, issued goods to increased as XX, the can million the Vifor. for of approval of were XX, after used million Total regulatory $XXX.X in The ended for clinical compared consisted out our $X.X is closed. for December ended of Cash, for quarter found the million costs build XXXX quarter the XXXX, profit full $XX.X revenue $X.X period relates was September key

revenue, reported and contribution Finally, operating for outlook. rather with securities conservative we have I'd we This this KORSUVA profit over guidance plan into this are to but currently runway I call the the the our going and a out assumes expect share not a runway that our is turn forecast will forward-looking anticipated to cash to that of sufficient for cash our XXXX. consistent quarter. current equivalents point back first levels forward now marketable unrestricted fund KORSUVA half available-for-sale revenue Chris. like now

Christopher Posner

And to your with Ryan, questions. now up be take Shannon, and Jo questions. the call I that, you open Ryan. for can happy will Thanks,

Operator

Instructions]. [Operator

the of Our line first Canaccord Sumant Genuity. question from comes Kulkarni with

Sumant Kulkarni

have couple. a I

that Is on it's a be? readout And U.S.-only dermatitis. a in so or question that XXX,XXX the what fraction is U.S.-only is in XXXX, the of clarification third in one -- or vials on the the to sold internal the get the A would first quarter. Street If shipped to expect what for my KIND number? half do that? second The communicate you Part worldwide, atopic the on When you second X were

Christopher Posner

your U.S. Sumant, it's XXX,XXX Chris. On first the only. is question, vials

the So that's wholesalers the from U.S. clinics to the dialysis shipments in

On the to me AD, that on turn let question Jo. second

Joana Goncalves

sharing: things Part yes, the second will pivotal selected be Sumant, we'll into dose and B so going the size, the be study. X be will sample for atopic the dermatitis, and second one

Operator

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

Joseph Stringer

XQ sort margins Two in looks margins XQ here. from came on 'XX margins very the It like us. the to similar were. One, what of

was, -- that this sales expectations? that of all impact Just were and those on then beyond? all that do are this in XQ? going those expect in is some think coming sales you -- is forward? online force. the curious Or And force the Were second if continue -- line of Fresenius fourth the impact from there in question the the you again, to that And was with of additional added addition quarter --

Christopher Posner

Joe, it's Chris.

is and Fresenius your Let me the renal came the On Ryan. force answer He last the last real turn to online sales the in I'll can then margins quick. question, really question, about it talk this the in quarter. force I reflective reflective Ryan, Fresenius of you -- sales mentioned the to... the numbers of do want the beginning then on of so quarter, third are margins, And third

Ryan Maynard

Yes.

Ryan. this So is

margins going the quarter this last, and and continue would consistent expect that, You're would right, from I that forward. very are

Operator

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

Daniel Wolle

we should Given prior revenue Just quarter the provided net question. last about was fourth increase demand for looking in vials demand, at what revenue? the observed million full how is, XXX,XXX the we think numbers should in XQ XQ represent to biggest the the is user $X.X much be of in change expect and then And driven XXXX? stocking? guidance reported today, that year a from should represent clarifying an by versus How remarks demand

Christopher Posner

Daniel, Chris. it's

one question me Ryan. Three is Let to Ryan. give guidance, and the three

Ryan Maynard

Yes.

for thanks question. This Daniel, So is Ryan. your

shipments to that important to that, of $X.X million So it's from note revenue Vifor wholesalers. is

you're not clinics. So XXX,XXX that wholesalers to talking the is about, is that which

So that's the important first piece.

revenue As stage. We're KORSUVA, second full to But guidance for for quarter. not include the in X not at we you innings, we're we're come conservative year runway, KORSUVA very guidance of guidance the I thought was on guidance. at is the gave going we're did, and launch, KORSUVA early revenue. the which far revenue year QX, as full on see, the reporting yet to in We're second we give as to our off important give of which quarter

it to be was helpful. for prudent going Chris And turn back question. I'll that thought So I and second the to

Christopher Posner

said quarterly the true I've XQ Fresenius, the really on I as MDOs, demand of. -- I focus QX the saw a in mentioned. really ever IDOs, we But demand, the -- call, been in be in our the a acceleration launch We're acceleration with of a is in in came and good demand going primarily pickup Yes, generation, that's to again, pleased quarterly Daniel, in focus part focus DaVita. that on gradual from also, in any my kind That's XQ.

DaVita. pulled demand to closely I So fully going acceleration continued in is and quarter, the we're eyes fourth well. expect through continue. be look at uptake how would are to at And And the our product going Fresenius this on getting see to as

Operator

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

Chi Meng Fong

for Chi Jason. on is This

I IV First could one XXX,XXX but comment on is from curious shipped sense on get account for to If gross that centers. on roughly ballpark? right to where $XX if wholesalers am recognized, about I'm net, to to the per trying comment not that's price be if roughly the trying think I gross are to I net. that, sales to of helpful. can make KORSUVA, this dialysis I in around you net -- million Am shift? vials if you vial, you that, on it gross understand the the would

DaVita second centers. The all your on question is colors the appreciate penetration I provided. you in that the

have all all You centers from they of of Fresenius you've from order, order almost -- lot them or orders almost XQ. a orders -- the primarily in

sort of the can see -- these give would you dialysis if So KORSUVA on that -- IV KORSUVA DaVita penetration ordered driver your IV in a in proportion be will be DaVita, little And that what centers flavor to get of XQ? centers, with additional main you how helpful. what in do

Christopher Posner

Chi. certainly, Yes,

I'll me DaVita. gross net back on Let and come to the Ryan, and address the pass to

Ryan Maynard

again. here Ryan it's Chi,

So understand it little I of a bit takes clarification.

to that that we is is all the So to net report, report, gross from we shipments Vifor and will wholesalers.

organizations. to And net XXX,XXX the so to gross dialysis get shipped the going we're into related were that vials the not to to

attempting are what based on we've reported. do you you math that the to do So can't

hope I helpful. that's So

Christopher Posner

in they call, very with strong on even call, I the to anemia have a to treatment point also DaVita, a in was I a out the I'd more we signed also Vifor, tend acceleration primarily special portfolio that place. also DaVita on adopt they ramp-up they their they number expect Yes. relationship dialysis seen a selling my mentioned, relationship point erythropoietin also DaVita. gradually. to have protocols do at remarks and, Vifor's Specific bring deal unique strong products the But in the and saw products actually Fresenius, that DaVita, including on an seen other recent their and a DaVita. clinics expect ramp-up, them prepared of we on of customer is new they steam, And have we providers, formulary in we've with CSL have this just ordering mentioned that gain major And And to they new increase very for and even protocols continue. DaVita, acceleration in clinics, continually Fresenius that and out and with in of Chi, though but products. KORSUVA as across I'd DaVita, mentioned and fully CSL

that this continue their adopt to So net-net, confident patients. gradually it product we're DaVita in really and going for to bring is

Operator

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

Unidentified Analyst

by First question for me. This way. the is

DaVita Fresenius on between clarification a Just Fresenius the to the versus this DaVita a Is sales. time? between difference there you've observed vials that shipped versus at

Christopher Posner

really MDOs, that mentioned extent, of mentioned acceleration in to and, in bulk the I a was the third the clinics, the Fresenius -- DaVita. the Yes, lesser demand with kind I IDOs also quarter, of

will, double-click in on the if third demand, of kind the you that's So quarter.

Unidentified Analyst

you. Got

So can... I

Christopher Posner

cut you think I you , go. There off.

Unidentified Analyst

Okay.

My more commercial is on -- is and after Sorry the revenue. this supply question one that. have second then about I --

So we should state of about Or should down the or how be of inventory? we about steady equalize -- long-term thinking Will kind thinking time? draw that? should how think we be it -- how it over will

Ryan Maynard

Sure. again. Ryan here

that is and yes, in the it and agreement on Vifor I of shipping solely manufacturing this is So the us focused lumpy. But definitely recognize mind is that. product Vifor. an to it between keep that

So with the manufacturings the to relates through it batch timing the of moves which and how less demand. mainly and

comment how probably can and lumpiness going it's to expect but a I'm being understand lumpy, not little So it's forward. you I manufactured, going on

Unidentified Analyst

question Okay. and just awareness promote not That with is, additional CSL efforts are Cara helps expectations. there advocacy the to last then Vifor And the my by and any program?

Christopher Posner

Vifor partner. our is commercial mean, I CSL Yes,

good and Vifor. there's And you this we're launch. market into market can nobody -- a that's with we job force, have and intimate space build move sales remember, we're as to are product. Vifor they the and in And -- partner talked added nephrology. And And contract and know-how So obviously, somebody then with This X an really the in CSL They're than dollars to intimacy see you dialysis and exceptional launch doing CSL market on is Fresenius. exceptional better a not CSL I quarters frankly, expending the nephrology a building that results. we before Vifor. than a quite Fresenius on, between

we're CSL in. so building the results to we're market, And of and to actually with this the X really Fresenius quarters pleased starting Vifor and see dedication incredibly

Unidentified Analyst

consider Okay. directly, advertising? you would Maybe more

Christopher Posner

CSL Vifor the is doing advertising.

Operator

of comes question next Stifel. Stacy the from line Lee Our with

Stacy Lee

square And CMS will on then Annabel. and that that is sold before secondly, wholesalers is when have questions then the steps innovative up? drugs? period on in This quarter. occur And when the X revenues clarity figures Realizing what change for dialysis in point great need there? then vials made ship the when book point that from wholesalers, Congrats post-TDAPA these to line you time a providers just see we more Stacy calling are at we on is regarding the the the you order to X proposal there RN. the next will mechanism for What in a

Christopher Posner

going kind expect still. and typical head an launch. I pretty they indicated for that's reimbursement rule. so exact few in see final inventory last And the in rulemaking in or down to to ago. Stacy, the start they drugs. the give would that quarters. I out they're lumpiness to as address did the but it's X any we would I is the RFI, to expect of Yes, with innovative settle their address variability in they CMS post-TDAPA I and next future normalize though, as Ryan the some kind possible can't And rule would great more of did XXXX. to terms of expect consider trade comments do, to question. final over weeks XXXX. they acknowledged say consider likes into date, that demand, What week equate came in them a to comments and CMS, not

something And what we more That's rule-making contact well, of this CMS CMS expect I we in time is open will other as KORSUVA cycle. important -- Vifor really what in say, efforts, feel even for mind rule we, would So year. That's strongly this doing there out that expected our understand with here. it's in and this has of to probably is next be CSL be XXXX, lobbying comes Cara, resolution and with very XXXX. continue before key final be et will stakeholders Stacy, -- period the to I'd also hear expectation. that They which TDAPA cetera. that kind an

hopeful come XXXX really clarity the are part will we more as rule-making So of cycle. that

Operator

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

David Amsellem

So just a couple.

revenues not XQ in early get demand? like So inventory still given to sort be some there more the that still what or there of a real vis-à-vis wanted just inventory. going an is for of just I a to going stages clarification question. is to look launch? may may XQ be approximation in Or So -- Will it we're the sense like just look of

to would DaVita be And more you if new tends to will. ordering Chris, you think how that be then secondly, -- earlier, and mentioned I about be tends gradual, general helpful. uptake in product

tend wanted Why to to Is why a DaVita's So specific does Is general be to operating procedure? that helpful. you to just standard of just it sort would uptake KORSUVA? anything get be a from That it as sense slower? is.

Christopher Posner

you. David, to from Yes, hear nice

start to I a lumpiness looking and That's to you're sometime your be, market first to question continued obviously, I going mentioned what's that's in demand. expectations are on still previous and as word, What not ramp-up critical. I demand. pretty terms there is normalize typical is building of the to expect again, just And when guidance. taking to And next But question forward-looking So expect would people in Ryan's from for that at that we're product. would trade give inventory XQ, year. Stacy I'm around a

not does well. clear, adoption. on their with doesn't as gradually a gradual rationale, more sales like appropriately. terms And get in saw that just a DaVita mean, of I a is product force tends bring Parsabiv. to It's organization it adjust be experience, Also, David, Yes, Fresenius We DaVita. on question last have Your algorithms to it to specific to KORSUVA.

is at very of seeing is rapid actually important on though, Fresenius. pickup are We we terms uptake right? DaVita, seeing seeing are rate. week out, in good strong we week, coming those that's on board having significant, we're reorder that that more which would also coming that board another and seeing I to clinics So are in point a lever are a

about from our So organization. where the are And of to expectations we kind meeting good DaVita come. we're and excited we actually feel really quarters about really the

Operator

[Operator Instructions].

Our a next from Kulkarni Canaccord is Sumant with question follow-up Genuity.

Sumant Kulkarni

look ends? If question, question on when rate of still process do better is what rate setting is a on sold independent key reimbursability This to. vials get to you need lines to how time good is rule-making think premature TDAPA have forward a the that's some this we run to a how quarter's But trending this to where the relative this latest thought process post-TDAPA? many are utilization for quarters variable see vials we'll

Christopher Posner

And market. Sumant, on really We're Yes, if quarters the building utilization. question at X a the quarter, a you Fresenius. a LDOs I the terms strong in. just super listen, and came think again, namely board with mean, CMS of they of in look third we're acceleration about in really, how on

potential population state, get just fully we're going what continue up. help too, payment to TDAPA, TDAPA patient rule-making through years in we funding of as bundle added it the data, CMS estimation they steady typically a a to utilization of saw have I'll we Sumant, would of to on look full of important, will I I of the really I additional or X KORSUVA sense on good kind the there really cycle, obviously, that good funding. at So years conclude, either utilization. really expect itself. to ramp to to of an the sort good And of -- end near have of was was within And their a think year potential And terms we think Parsabiv, the calculate with X utilization, add-on

Operator

remarks. I'm showing the currently questions for to Cara this will the you. over team at I call no closing now time. back turn Thank further

Christopher Posner

in continue And thank joining excited clinical Shannon. call, Thank and leadership, you, with Yes. trial on you, And focus and a KORSUVA continue both everyone, as to quarterly our execution execute partner, we terms adding and, we'll we're under for really, our programs. about our value. short-term of company are Jo's long-term where really with IV to

with that, you. the So I'll conclude Thank call.

Operator

today's concludes your you conference call. Thank This for participation.

You disconnect. may now

Cara Therapeutics (CARA) 8 Nov 222022 Q3 Earnings call transcript