Earnings call transcript Q1 2023

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Operator

Good afternoon. My name is Lateef, and I will be your conference facilitator. I would like to welcome everyone to the Cara Therapeutics First Quarter Financial Results and Update Conference Call. [Operator Instructions] Please be advised that this call is being recorded.

I would now like to introduce Matt Murphy, Cara's Manager of Investor Relations. Mr. your begin may you call. Murphy,

Matt Murphy

and Thank afternoon. you, operator, good

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

Cara based be Before are uncertainties. this and conference of management's during the making forward-looking and statements we certain course expectations. begin, programs XXXX, Securities risks let under are me remind Reform and statements plans current being and about we Act to of on the you will our Litigation that These subject call, Private made

to update revise the XXXX, publicly XX-Q XX, differ December of factors information subsequent a reports risk statements may year the new XXXX. or the ended with result including forth for set due as results and read future ended Investors factors, should materially March any developments. XX-K obligation the results and or quarter Cara's or various SEC, these its Actual no XX, to Cara in filed for undertakes Form

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

Christopher Posner

call. everyone you and Matt. our Thanks, afternoon, Good today for With joining are Financial; Dr. thank Medical Joana Chief Officer. our and me Chief Maynard, Ryan Goncalves, our

giving overview what of by quick I today. a to start address I would like will

customers to of and clarity progress into the These I launch also segments show of I give help tracking progress countries metrics around injection For provide the on the opportunity give we review within and in U.S., market. to the KORSUVA world. the some uptake. launch different the in insight the update and demand will the will are the that will better additional

difelikefalin. clinical robust our highlight programs oral for of value the will advancement pipeline sales I addition, our high and development In

open After to communicated to I progress confirm our that am continue can timelines. Q&A. to update, that to provide and a the you the and with Ryan we we call track financial pleased up will with will previously date then

begin will injection KORSUVA of the I launch U.S. with the in

for revenue dialysis quarter For into as and Wholesaler XXXX, the were shipments to recorded $X.X net $X.X more translating us. of reached million KORSUVA than doubled profit to first million, vials. clinics XX,XXX quarter-over-quarter of sales

of to and XX% supporting vials the were or on organizations. this providers and between FMC the in positive, This expansion Anecdotal feedback split its these both increase DaVita acceleration shipped be dialysis with highly shipments vial in Fresenius other KORSUVA to in a from patients in continues remainder breadth meaningful demand. and utilization. suggests clinics, depth

more the QX. orders first By quarter-to-quarter, placed of FMC, FMC clinics reorders, clinics up at vials. XX% of the of reaching end end At the or XX,XXX had X% XXX quarter, tripled from than

one of XX% of or least end at clinics, X,XXX clinics importantly, up More had QX. from clinics FMC patient, XX% of dosed the at

remains Total clinics. the demand specific difficult inventory to information patient assess at individual levels about remaining of without

the FMC the mode FMC we be growth quarter of a number third However, of the to inventory this clinics second XXXX and of exhausting that clinics the reorder see continue in significant bolus half year. in majority expect their will in

among ordered DaVita, end of end repeat XXX with very the of Reorder encouraging, at At these orders. up the XX% quarter, clinics, continues clinics remained At KORSUVA, to of or clinics first steady. placing clinics X% growth of DaVita demand XX% from had QX. be rates that’s

growth proxy for clinics Given represents the a the approach in the clinic for in DaVita at growth on demand. patient good ordering KORSUVA, orders demand

that's XX% of up placed of these and the end QX. At orders, [ph], at first DOs midsize continues XX% the had to and KORSUVA the from of end perform independent well. At clinics quarter,

placed of clinics XX% these repeat orders. addition, have In

of largest group has this that's orders. clinics have the strongest Roughly repeat of ordered placed amongst KORSUVA XX% the performance these XX% DOs. Now have and at and of the today midsize been clinics USRC,

picture, at KORSUVA's penetration the untapped. looking make the CSL of Vifor building the significant deal of To leaves and majority the idiosyncrasies back market in is quarter. overall get Stepping continues segment with reflected room market key there, the to still big across entire this a market, landscape. progress This for vast navigating each growth, trends

clinics our Vifor clinics the doubled latent XX% fully quarter-to-quarter. orders patient upside ordering dedicated remains increase remain seeing to and in in this the the of KORSUVA Almost and and commercial each potential a product. long-term. Clinic the FMC maximizing an partner of CSL are is segment We capturing in market dosing confident

CMS working remain during We designated and funding for are reimbursement TDAPA additional products will kidney collaboration that the a remain post be cycle. for need with TDAPA we understand in durable Additionally, period. TDAPA mechanism update their substantive year's for be designated released help close this the appropriate available and community we a will to hopeful products, and confident made positive that rulemaking

providers countries, Switzerland, Netherlands and into in The rollout Kapruvia the seven. Europe has four to with Kapruvia and patient gain have been first in received launch revenues the to bringing Finland, we In in The initial translated U.S. international million front. from the of the royalty of the net additional us. on to Next, of feedback France, patients begun in line very in $XXX,XXX number has $X.X sales, total momentum. countries quarter, the continues testimonials generated and encouraging Rollout

second the Japan, we Institute to or expected to countries expect other the in imminently. NICE, countries world U.K from Europe is continue Also, months We XX next a the a Health the regulatory XX once decision additional half to expect National Excellence In the reimbursement XXXX. for Care is continue secure. online and in and throughout come decision to of around

$X milestone a would approval As Cara. Japan in reminder, trigger a payment to million

dermatology promising being medical a franchises least, our company and treating we like long difelikefalin. a I'd with Fundamentally, are oral building not goal run. oral world our company efforts owned us of as certainly pruritis development in briefly drive to differentiated is the our but pipeline. to to leader Cara These chronic Last discuss in wholly nephrology and the committed will

chronic programs of We X pruritis of trial associated in program and in first the Phase is X our atopic in dermatitis this half results kidney as our in XXXX. in A the fourth anticipate Part with year with quarter KIND advanced this of from Enrollment internal top AD expected. readout progressing disease final line the

XXXX. kidney program We advanced also for continue half disease results KICK to expect the our top line in of second chronic

well. activities of the tracking Startup of second this half to in the our in A the program NP the kicked paresthetica are first in results X XXXX program quarter Part final notalgia half of in topline X/X and they of off Phase for The is progressing readout KOURAGE and XXXX. program internal for first year, the

closely to continuing uptake KORSUVA, with accelerate and CSL Vifor are near-term of we growth. to remain confident we drive the will summarize, To efforts that work these

optimistic mechanism hearing decision feedback TDAPA highly providers update the post funding injection. on year's patients from Underscored around hope this to Additionally, by during CMS's we continue world, future we the see of KORSUVA the to long-term the remain success in and an are and positive regarding rulemaking cycle. believe we

tremendous with with oral we value programs importantly, our stage late see difelikefalin. Cara three for creation More

rapidly therapeutic our progress as updates the within are these providing potential We We this programs two order you look advancing throughout year. difelikefalin franchises. to on possible to to as our fully committed in forward maximize with

first financial over call Over Ryan. you, Ryan to to additional quarter for on like I'd details turn results. Now to the our

Ryan Maynard

of sales Thank was million Revenue to ended consisted injection same X $X.X million March you, to collaborative profit of quarter third $X.X from for KORSUVA period the and of Vifor's XX, million supply to XXXX. revenue. Chris. net compared million Total $X.X of parties commercial related our revenue this the XXXX, CSL for months $X.X in revenue

the our sales first quarter, of royalty quarter Kapruvia in revenue XXXX. We from $XXX,XXX also net recognized royalties a of of this representing the

commercial million Cost of XX, development to during million CSL ended to compared sold KORSUVA supply is for late XXXX our R&D were relates to programs. and $X.X injection The was ended months Vifor. the months XXXX. shipments the $XX.X Research increase clinical of three to the increased of March expenses due in clinical $XX.X and goods our stage X period the million same XX, March related spend in to X expenses primarily XXXX,

XX, X to XXXX. in was $X.X due former of modification reduction stock-based March million compensation same of to period of XXXX compared XXXX. in in the same the our included The Stock-based expense million the in in a compensation decrease as the awards XXXX first to expenses CEO. the period to compared General ended for quarter and related G&A certain were to costs in administrative $X.X months XXXX, equity

Cash, in resulted activities. compared $XXX.X totaled marketable XX, XXXX decrease from operating in million $XXX.X and March The used securities XX, at cash to equivalents our December the balance primarily at XXXX. cash million,

second plan available-for-sale and equivalents currently We our sufficient half expect and fund operating are cash current the to of anticipated our cash unrestricted XXXX. securities that marketable into

the guidance stage assumes share contribution. development programs, This spend all KORSUVA clinical late to three related and revenue our profit

I'd for that extend our non-diluted to certain runway financing Finally, opportunities exploring like to we highlight further. are everyone

I will call over Chris. now to the turn back

Christopher Posner

difelikefalin. a in behind that remain making are confident on of additionally, laser And want we oral Thanks, I injection to KORSUVA pipeline focused reiterate success. Ryan. the potential launch our the we massive

help value We strategy chronic in leader pruritis long-term to our world goal ultimately shareholders. delivering achieve treatment have our will becoming that the significant us the confidence and our of full of

to take Joana, Ryan, be that, With will happy and I your questions.

Q&A. for open let's up Latif, So line the

Operator

Stringer question of Joseph. Operator and Our comes Instructions] the Needham Company. Joseph Please line ahead, of first go from

Joseph Stringer

for Hi. our Thanks questions. taking

into the it clinics? still launch of gain expect would the Just again, us inventory visibility at progresses that the the few inventory have Can to any to from then as visibility on you make that levels secondly, constant this? you something that in wholesalers, here. relatively is us. Or wholesalers? [Indiscernible] the opaque? inventory And levels Thank is? And is remain you Do you that's remind ever that what you. and into

Ryan Maynard

nice Joe, you. hearing Hey,

those. of both tackle me Let

at level. So the the inventory is around first Fresenius

needed clarity give important and inventory. in this and how particularly through One to you to key wanted really really we existing we clinics performance on opportunity with to demand it additional CSL, was the provide we were its uptake that FMC we and of and the indicators its felt knew focus or working more on And quarter, metrics market. things

being X,XXX a that's is I a clinic utilized mentioned So patient the how clinics are metrics rate, product that have dosing at we level. actually Fresenius. we're that's providing to a insight around penetration roughly the best at what And

couple roughly specific here, from that, remaining. are they've because many actually of exhausted second is have don't and important And then clinics that clinics you what's much and the their the that's inventory good rates. a there that is reorder Fresenius critical QX. how for using But clinics. the particularly important product And and insight the that's are XXX We and you still that shows is dosed up gives with sense metric metric metric recurring becoming customers that now how inventory, clinics XXX is have how patient many that in of end that into

So punchline in that mode. drawdown we're of inventory And really in the be FMC that and is about exhausted majority there we midyear think that have inventory. really the the believe I will by their clinics reorder encouraged

Into wholesalers, but that it's pretty your it we run specific the level, traditional know don't They CSL other I the wholesaler not second standard. really at versus question, their contract inventory between atypical -- markets. was Joe, and

So, of weeks. it could a couple be

Joseph Stringer

Great. Thanks for questions. the taking

Operator

hold Please our you. Thank question. for next

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

Your question please, Annabel.

Annabel Samimy

you for just Do others. considering have drill your Fresenius that Yes, with questions comment Thanks you're with my specific to you're follow-up that with to down some the tools for efforts the able first do taking to that's that I'll and want guys. any before? progress. accelerate to I on uptake. be working question. Hi,

Christopher Posner

is really down mean, top entire I working base. Annabel, CSL stakeholder the Yes, bottom doing of a nice job Vifor up really

tactics Fresenius to the So, I engaged a I'd also activate that sales is and right, from mentioned peer series the patient have to employed their utilization. force that initiatives. peer actually force they sales really direct to drive as of well, Fresenius and they've And to programs deployed they've mean, clinics

getting and X,XXX significantly down line in number mode. the there starting is that seeing of clinics clinics up a And reorder that versus Fresenius increases of therapy, actually seeing and on that's the patients inventory that's number we're to starting now that and of quite at And QX. we're those kind punch draw

they're So that to Vifor is as is starting this doing dividends CSL the market. really pay building things

Annabel Samimy

go and if [indiscernible] they if us clinic Are noticing And but it? are start there? little level get using it, pretty sticky? ones they is that are they touch it you And and [indiscernible] any details, someone they when a it. give getting using, got -- board those pattern start? starts on bit start you Okay, start of the this still once a Or reordering

Christopher Posner

buy at using from becomes really patient that across force hear seeing strong will. performing basis, there's clinics you once hear as see that's product. that, well testimonials, really and we reorder of a that growth Annabel, we nicely. clinics we're on metrics at is two that's provider I why the Well, a metric the But around look the we what products these say sales majority from reorders. look the and data anecdotally, really it I we And the start testimonials, the key in And product continual that the we're that board, And if annuity, in as encouraged. and there's the start actually

Annabel Samimy

Okay, great.

there to [indiscernible] going actually Joe, that's the just program. helpful. development yes, So, And I'm throw about question a to out

tremendous notalgia development. or amount a not on So an with paresthetica -- has oral NP indication of been so difelikefalin

rapid So competing no programs? be here enrollment what expectations how the treatment for real could essentially are as with your first

Dr. Joana Goncalves

Thanks, Annabel.

very very as it It was us. on Phase England as sites now. which operational received X and in starting study where as think the well -- program. we New [ph] this interested these is having Journal for off. the phase complete are sites many the to was not helpful in about we're Certainly kick confident to I sort come very looking And program really participating, our at was of it

before, as patients. I who So very that's physicians for think are we've these sure. the helpful And said see dermatologists

enrolling we So patients. the and that for we out remain about put very these encouraged confident timelines have

Annabel Samimy

pretty patients or positions, these of certain Okay. kind among And concentrated scattered? are

Dr. Joana Goncalves

Not that to seen date. we've

course, of little our program, X this bigger So, a be bit study. is Phase therefore a than

as -- sites are we So on try well. just to board having timelines meet to more and those and

particular concentrating but quite area, not any we're [indiscernible]. So doing in

Annabel Samimy

Okay, much. great. Thank you so

Operator

Thank you.

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

Your question please, David.

David Amsellem

Thanks.

in the on more of you've I in to So on to on that DaVita. a process DaVita terms drill down comments said activating think, have accounts. And past, wanted your Chris, tends slower

on wondering comment that on of try That's United can secondly, relative clinics comment have if number that you what you DaVita? to just doing qualitatively is one. pricing then, just we rest in your And is seeing Europe and the you're States? I'm can that? XX%? out to to jumpstart world across of the So if what of you. have And what and surprised Thank you Are partner you ordered could number that

Christopher Posner

David. Hey, Yes.

a me Let tackle briefer the That's last conversation. one.

that we I €XX in I And public a per in vial. the have print, So in have may Germany Europe, QX price mentioned did. hopefully, is that price

So the the by and about third of vial price. large, it's is price of which the U.S., list a in XXX

reimbursement you around And and speak that's country, their I come obviously, work secure why to price online. -- to national will with bodies can it sense, Germany. So gives a they each publicly and as a the

to mean, experience out new in they roll nationally a Your will available first of area try I have then adopt question the more see patients. you where to this, a nationally. and real they gain around more commercial DaVita, for alluded I And a priority phased David, concentrated they to I way number of and are in country. a is It's yes, products. a tend before, to they now, take DaVita different They say starting us pickup approach, dosing have world clinics it partner. our the of

for certainly things sales to thing unusual little that doing DaVita have it's of not And that do experience, two doesn't a internal DaVita educating in lab force. and my we the are a Fresenius little educating differently. a a things that factor an luxury differently. one From the DaVita and And critical really techs, critical dieticians of to piece different Fresenius customers that's are driving puzzle. And the workers social nurses, than different ability and the the access renal educating with is utilization see is clinics.

And from some things, lasting And doing? be partner series there's mentioned, a of doing effects given our DaVita, access have Well, a you creative. these what's they pandemic, restrictions. they're more bit the to

learned via CSL lot engaging doing. and conferences, around digital Vifor engaging So a that's exactly means, is we've what at

a Fresenius significant of but that, the behind is a ordering. pickups are point we they're new seeing clearly, month-to-month number think clinics yes, little in here I

that David partner that ordering, always most to the significant patient once this, back our of important I and over come starts are testimonials encouraging the clinic continue that is reorder. things And given testimonials, to is to generates the of clinics us product, really provider and really that to one a reorders. And DaVita utilize that XX%

annuity. growth a really it's nice So

David Amsellem

Okay. That’s helpful. you. Thank

Christopher Posner

it. got You

Operator

Thank you.

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

question Your Jason. please,

Chi Fong

first KORSUVA. on Jason. guess our IV Hi. on I This for Thanks for one Chi taking questions. is

inventory should through your You expected came the by the when sales might DaVita be me, what You clinics. underlying compared given pardon And maybe the timing to and readout readout, outcome -- metrics, on to you demand? the the order fourth if the drawdown trend -- regarding does And quarters? internal sales -- will trial to like with what's oral earlier. rest you talked Can other are what two in think they Fresenius, internal scenario, how some with demand? that the when expect the we gave How past I missed quarter? some converge from Thanks. XX% KORSUVA. with that underlying metrics will around about about thoughts we on of I the AD walk the But midyear. from think what can one the second latest converge on have us

Christopher Posner

Chi. Sure,

that. unpack me Let

over and clinics, QX, what me That by did part quarter Chi, first your demand Given the ordered a stocking the vials evolution dialysis XX% order. this two mention they Let aware, asked of was question. how Fresenius in did did roughly And we you XX,XXX kind first XX% Yes, or of as beat to quarters? orders. from Fresenius by the driven last the -- you're compares ordered Fresenius. that were significant of are

So XXX,XXX QX, about of product. the vials, I in obviously there that think the that all was starting And they're QX, Fresenius, XXX,XXX of that primary then driver pretty Fresenius. was much utilize to was

independent XX,XXX vials midsize the about split in and and would used So the was between QX, probably Fresenius I rest and was the DaVita say, XX% XX%, DOs.

in order moving we're at would to more terms So Fresenius where is akin will of it key expectation in vials what forward quarter the driver be be seeing fourth XXXX in probably our or demand. least

Your that would expect we demand kind and of normalization and have majority be we the second clinics down mentioned by of what drawn the sales. say their I reorder mode. midyear, of question Yes, inventory around FMC to utilize in

I we get you'll year, So the of as half and start would probably sales sort the to see demand into converge. say second of

the let me the part then around oral. last Jo your of question, to that And give

Dr. Joana Goncalves

Chi. Hi, the question. for Thanks

in as is A So, Part this are patients currently we will enrolling XXX be we reminder, that And A. Part what a have we enrolling.

is a Part as the Just number reminder, us an will that information this of B to KIND give patients or X. appropriate into continue

specifically will so the benefit profile. all the will specifically to And most the is be demonstrates size. be look looking and assess that favorable dose the at looking that select risk at well best efficacy looking we we And to we data at the at sample will And able be so as to the as size. sample safety dose will able what take we

Part focusing specifically we what A. for and be on sharing that's will So

Chi Fong

go dose the that or a and no is heading clarify, in into can selection or determining size baked sample Part just I B. basically go decision If there,

Dr. Joana Goncalves

what or dose and and to outcome are the reviewing the forward of sample looking demonstrates will we for Yes. of assessing but data course. we not, the exactly the size, be assessing the Well, move data whether at and

Chi Fong

you. Thank great. Okay,

Christopher Posner

Chi. Thanks,

Operator

Sumant of you. from of [Operator Kulkarni comes Instructions] question Our the Canaccord line Genuity. Thank next

please, Sumant. Your question

Sumant Kulkarni

product so details could some taking how partner to and to Definitely. market my of you dynamics. operating that happen Thanks all start question before be on for for important product you this revenue? substantial and steady the state would current TDAPA Do and hit collaboration that realizing your expect margins

Christopher Posner

clarify could a asking muffled -- was you maybe little Sumant, it friend. you're me my

margins of comment you're the product? for So CSL to me this on operating Vifor asking

Sumant Kulkarni

important how is before So would ends, hit to be it steady not the specifically for the margin any a state product operating I guess question. quantitative, TDAPA but

Christopher Posner

I don't -- Ryan?

Ryan Maynard

Maybe Utilization you utilization? … focused is on are

Sumant Kulkarni

wouldn't if of That’s and mean, bottom I is collaboration longer in asking. example, down time like, flows that thought, otherwise line? Not mode for the revenue product a really. rate I your impact recognize, what that than to for that the was launch you

Christopher Posner

I got Yes. it.

he's agnostic So Ryan, about asking to the split. maybe you could. profit It's that.

Ryan Maynard

I've is that points. profit Fresenius, that split mix given and or DaVita, the Yes, XX% more which percentage DaVita, And the I think of between the more get Fresenius by how every works, X we guidance X maybe dollar. roughly fluctuates on

really not it's material. So

pretty So steady point view. it's going be from of to that

Christopher Posner

Vifor, commented, doesn't marketing their from controllable just Sumant, And, impact split. that line I like expense that on profit the necessarily on CSL expenses

Ryan Maynard

it's Yes, fixed, Sumant. pretty

Sumant Kulkarni

definitely absolute than split, more Right. That’s [indiscernible]. profit net but dollars,

Operator

Thank Posner, I'd for closing you. Christopher to At time, to back turn like this call the Sir? remarks.

Christopher Posner

this Thanks. to just indicators Thanks, really wrap clinic dosing Vifor I seeing order. take clinic clinics CSL injection, make or I minute progress you said encouraged. with really the each key mean, we are the if FMC And look increases in performance want at orders to trends market. key I patient. of KORSUVA quarter. specifically up. of a a things segment just business, my is Latif. in It's Yes, the this the Clinics XX% are in reflected comments, to doubled. continues building

it's So encouraging.

reorder from Again, very really we're strong positive and of on are. And into very where patient both And rates. translating getting very terms positive physicians we feedback that's the in product.

mentioned to of good Joe We our little commitments. make pipeline stated that really to our continue in a progress. And

progress. we forward to look net-net, launch to we continuing our KORSUVA the update of pipeline on and So the you really as progress

I'll end the So with that, call.

Operator

for conference you today's Thank call. concludes participating. This

now may disconnect. You

Cara Therapeutics (CARA) 15 May 232023 Q1 Earnings call transcript