Earnings call transcript Q4 2022

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Operator

Good day ladies and gentlemen. Thank you for standing by and welcome to Akebia's Fourth Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today's conference is being recorded.

the Director to of hand Mercedes speaker now Senior Carrasco, Corporate will conference your over host, I Communications. Please go ahead.

Mercedes Carrasco

impacted Thank lives quarter the who purpose and kidney healthy and to kidney an opportunity Akebia's community XXXX Kidney recognize of awareness celebrate welcome better by call. to results for raise also conference business kidney you, financial our updates all Day, share we World and people in to full disease. the and year Today fourth those in

me for we call, Financial today's Executive Officer; have Chief Joining Officer. John and Chief Butler, Dave Spellman,

Our website. press year detailing XXXX earlier investor is Thursday, full our and results, March the that release release Xth, was issued financial available and our fourth of quarter on today, section

today's convenience, also after replay will website our your be conclude. on a we of call available For

Before call I'd these differ this and this results cause remind includes statement statements. everyone is actual forward-looking uncertainties subject we that on like described in forward-looking risks from those to could call Each begin, to that materially statements. to

update our Discussion and Additional Analysis is the the on release filed press Risk results as on law, included and by we the statements as we risks the quarterly revise issued Factors reports this Management information with financial that March of in SEC. annual only in of section except The any X, any as describing required most these recent do well and to this to call, obligation speak call or forward-looking these original undertake and date statements. of not

Butler. John our I'd like that, With introduce CEO, to

John Butler

a Through and past XXXX us. decisions us Everyone made the with have a thrive year for our Thanks Mercedes, renewed Akebia at joining as work to and has position thank strategic in put company. we've team's all entered the optimism. you

engage to kidney on the patients continue Auryxia. our and with community support We

look in marketing process evaluate serious potential ahead of We've and prolyl we're for advanced point expansion potential for to hydroxylase potential inhibitor pipeline including a vadadustat factor excited authorization, we're compounds and opportunities, now drive hypoxia-inducible need. Europe approaching a regulatory as unmet to the developing where indications we

team a catalysts, and I'm as with development base, with a proud multiple strong today they've have of mid accomplishments revenue a opportunities. delivered that and long-term company near-term We their and product purpose works

Now XXXX, let's we Auryxia. team commercial begin the revenue that to revenue works credit over hard access In guidance phosphate thousands exceeding market continues growth reported a patients we nearly the ensure with established product product net dedicated net mid-year. XXXX, decline, of of Achieving is growth to our to while target binder to Auryxia. revenue XX% have

on launched effective believe focused receiving we the dialysis. to commercial coordinated high-touch are year, enable prescribers engagement our with and aligns CKD to including individual care entities We model objectives. that Last customer for advanced team that continue value will model new high cost patients, a delivering those

product integral development to plan net our research in for is vadadustat processes and continue drug activities. other invest revenue to as support Auryxia regulatory we and the globally our operating

Products Medicinal adults potential of treatment Regarding for late positive of anemia EMA a dialysis. February, vadadustat or the vadadustat, with approve symptomatic the milestone, Commission that CKD associated adopted approaching chronic the for recommending Committee Human for we're in a European quickly Use maintenance in Vafseo, the CHMP opinion on

this be all countries. affiliated We member states by XX in year, to for would Union granted the to European Vafseo anticipated applicable EC marketing of be potential which authorization May and

Switzerland Consortium year. also we for later EU and the for this the Australia vadadustat UK, decision countries, regulatory Beyond a anticipate ACCESS

process partner continue are in select don't to approved. partner authorization, delivering marketing kidney partner potential appropriate after in that the maximize sometime Vafseo We value of until can We but while expect treatment a reaching to commercialize deeply to select chronic patients. Vafseo option oral due to and engagement receives quickly to our potential to a patients Europe an Vafseo if formalize dedicated anemia engaged to with a efforts disease the we're

Vafseo XX as MTPC and Japan adult continue approved in patients vadadustat. be for currently in in dialysis. marketing dialysis-dependent end, U.S. and countries Europe that mean marketed a potential the benefit on in would risk approved it's We vadadustat for pursue authorization approval to would for non-dialysis-dependent And favorable to profile patients. the of believe by in we path

regarding Last year to In due the vadadustat, that second needs, for Peter we dialysis. request or staffing patients authority a formal indicating as related specifically deciding to we response for OND, the the complete the appeal. submitted Drugs letter FDA New resolution with received Dr. and interim the response on February a FDA serve Office dispute the the adult XXXX, agency of resource Stein, constraints from of Director will of

response has Stein nephrology, the to consultation and XX Stein when in from experts safety complete will OND review, discussions. completes Dr. and liver indicated seek a we expect internal he days with his cardiology Dr. the receive to

to continue will Stein the We update as Dr. on with investors engage process appropriate. OND and and this

indications, with year. shared investigator continued also study COVID respiratory setting, study study and with clinical sponsored this acute population ARDS to with and or in to patients from for ARDS. an distress evaluating expect UTHealth, we've data ARDS begin Since of related well-controlled to beyond UTHealth in patients syndrome an COVID-XX notably prevention plan in hypoxia. is for enrolling patient treatment a Last an that we other broad time, vadadustat evaluated Now adequate and work vadadustat being that acute the year, we

also unmet to fund To that keep our medicines connected to product Within our treatment other patients' to continues us indications. expansion. patients also the stream and development we're assessing for revenue expertise enabling have acute vadadustat and operations actively four walls, to and while a we Further, pipeline commercial team paths in end, regulatory innovate to needs. develop address

such as plan for acute options, development treatment multiple serious kidney of preclinical we disease HIF-PHI injury. or year also limited This with to no novel areas advance compounds

financial our to forward to of that do the look Our base new we do to strengthened through eager the year. patient pipeline. to us thoughtfully drives we've we're Again, beyond. focus XXXX invest and We're this expand into as programs in past because able

end, And ask more to Dave our our and to financials. talk plan I'll about operating that

David Spellman

John, that everyone. approved operating Thank assuming morning a and XX vadadustat Most have developed developed enable by important benefit May, immediately, has potential over will in an us patients. to capitalize countries the in XXXX we thousands have will upcoming potential XXXX. gets plan we for and build an drug as and was good the EMA approved second be that on catalysts year Akebia to will in you, we further value of

approval for could initiate ARDS for ARDS indications vadadustat non-COVID next in vadadustat, generate settings, we our in UTHealth study for population, with European secure acute the UK, our Beyond provide vadadustat other approval Australia, vadadustat for including and an a potential a expense data deal, profile preclinical ex-U.S. clarity licensing the in revenue U.S. the Switzerland, related countries, which secure in would process to to resolve the our and FDRR FDA, potential with

opportunities over new with of Beyond be our the infrastructure include may operating potential multiple vadadustat, with portfolio INDs development the and added our out commercial assets plan our within to portfolio preclinical maturation potential and our external programs that years. broader build for coming to leverage

XXXX for will the on our Auryxia time net based excess guidance $XXX million in revenues well, deliver period. of which continues XXXX XXXX, to perform over

return increase that realize $XXX Auryxia to of offset units million to an inventories partially that guidance sold. pill price reduction net normal levels, and we by in assumes Our in a total $XXX per

We also binder market have continues that to assume the challenges.

yielded Our stability strength for and us. has cost financial management important exercise

provide going us concern which fund cleared we have discussed detail, to but the of months. for in result XX-K, event least analysis the operating resources expect the given XX This two again. our to that worth main meaning we We previously have that upon cash our the of will significance great plan the of filing is at have the reviewing is focuses company, of

is and that Auryxia. led to success in year-over-year the most a obvious XX% increase revenue for net nearly First product commercial

commercial Few our to Our this including Many products growth, each and look on owed the [ph] those process key and alone on team, APR to of achieve revenue their fewer a our congrats more the account position are type net are to at commercial leadership team in contract sold. tabs that undertook commercial every managers. laborious deliver let brand market.

focus, growth. to We've stopped future just the our been of has Second, needed important, in our concentrated not narrowing with activities certain that our and several enabled into have people have strategic has R&D less more spend support contracts as which our exited order push were and and pipeline. that do money more return will asked items to we the on yielding

working expense capital In less debt than and addition, balance reduced we managing we otherwise paying are are tightly. our interest would have. Overall, our

focus to operating but We guidance expense cash on our time, offering continue runway. at we'll extending this are not

our with Auryxia, we afford a to revenue period, will can a during focus with post We'll both Our reinvest pre grow well as as we and we Auryxia only and from to to look ensuring in vadadustat high strategy TDAPA in on areas having remains maximizing example, for European that potentially this for revenues first value have by maximize revenue LOE, areas to look place partnership. potentially also revenue pursue.

you May. now vadadustat for are the all recently a in from On note, as potential we and that opinion approval a aware, positive CHMP anticipate obtained

on We a value the a successful this but indication. are and to as economics, deal cannot, asset pursuing to shares partner looking our the can many possible timely we mentioned, who been guidance ensure have benefiting John a will patients goal As within actively we our provide partnership with manner. in us at maximize approved of say for time as launch team the of

are to those Finally, going compliance continued filed in we are and with pivoting regain our today's questions. price call, take on have steps through provided On release, NASDAQ. the compliance, year-over-year for press not the to NASDAQ dive but criteria proxy the track into to to fluxes the will beyond financials happy listing be of appropriate definitive we on

questions. With Operator? we'll to the that, line open

Operator

Sandler. Thank [Operator And with from line you. the our Bratzel Allison question Piper Instructions] coming of first

Your line open. is

Allison Bratzel

guys. taking my questions. Hey, good Thank for morning you

us couple since on first, of you've February? of one interim the plan had communicate just appeal you response to I starts have And with just Could when and the Do understand follow any after So up in hoping cadence through then kind you you that. vadadustat just And a if FDA walk there. review? the communications late XX-day us the additional of Stein's for questions process. Dr. possible could events help expected clock outcomes

John Butler

thanks Well, Allie.

will do that to what He review. efficient finished that after It XX and we be. he's that has looking say in be his he's exactly administrative regular again, communicated exactly are internal can't to an usually days means And can't clearly say. so, this more we stress, the conversation else. And understand, we we the going what than is anything don't agency, to with of in timing just manner

So expectation don't out. the an to that I it can't it when to that be. you conversations. a clear But might But expectation towards that want those there's them set of I an not seemed guide complete longer that review in can't takes while we meet because letter dragging

kind it process commitment communication administrative when But you But as we that through communication. clock know will regular as hard we'll without there day-to-day getting say of is kind start, will going the I that when does. exactly it's isn't that so appropriate there definitively a will a process and to clearly we the XX-day update into we said, that forward as of understand tell

outcomes. asked I potential and And you about outcomes, so potential think of a there's so, number

product I is denied, denied This there's about was now. -- common very not the division the then know, just on forward to right? to and for the what forward. what -- think outcome would and talk very back for being a path appeal to the with being was AdCom but the that, be. appeal our denied, is is ultimately, You similar happened an but much they're path a one There a There tenapanor and path was an referred of CRL appeal that's approval to [indiscernible] identifying and an an there back that

ultimately leads So, give common that's that an appeal, approval. a deny they'll to where you but the quite path

granted your approval and could of communication. on NDA on in a or going you six-month appeal kind a an of re-file you're clock re-review be the a the then clock then review road to But there's to of which that's then the based your NDA. And are case two-month it part review

like path other from kind of what those of within don't think we that but So kind I things what up I a appeal there's are the is, things hear of think we there, might limited that of there an AdCom. but universe a might denied, forward number come know

something for Did else you have us?

Allison Bratzel

it. Got

John Butler

questions? followup had you say you Did okay. it, That's

Allison Bratzel

Yes, thanks, that that's no, and was, helpful.

FDA approval impact Another chances documents question thoughts vadadustat appeal label, that on just for something for before for just class that indicated or ask your is just that that patients vadadustat specifically a approval, that potential And reflects thoughts noticing the have and share the sense about about the -- could specific to vadadustat to thinking on label labeling there? that, question, four now your also that at months, also but published, interested in a your how TDAPA a the this of and you understanding I how outcome is that wanted your least successful hoping just been is kind does be for vadadustat? -- more it is just would cart [ph] horse might the for the dialysis review

John Butler

that I mean, be with FDA looks the like. fantastic having what about Allie. what that's be going it'd Yes, was well, to the to label start conversation out I

So, had haven't that yet. of know, course we you

couldn't So, approving class don't is mean, not. you what know approving class make be the positive products available a are from I versus vadadustat, in that all comment there's that willing the -- a to drug question labeling know, might considered I the signal no FDA they class. HIF-PHI on at think

that's think a there's my perspective. that to So negative I from no read way in way

our product impossible might is to look our be. product, And there individual would what label that right? like -- though, Every predict how an vis-à-vis is what

as what A the safe for think label. of FDA. will discussions effective. wait at do nothing the like have that Stein And in opinion, I positive is to FDA FDRR, Dr. lot Now, a of know continue a now in the data. product kind the but can't have looks CHMP XX European with similarly be decided from is for not said, kind confidence countries positive of and I we those I the come just we to the but labeling

on And process to so, we'll as we'll we'll communicate but our the all, end as quickly we again, it do can and can. move everything we effectively

Allison Bratzel

able then color me prepared from Okay. understood. just there you the question came wondering that from describe understand that both cash just last And trajectory R&D up Yes, guess in SG&A? expectations for course us or is bit over is once do I get something a a help Thanks. to more burn XXXX I you'll can just for the and trajectory. remarks, the any if on maybe this And but be expense just of answer FDA? to expense you provide that

David Spellman

Yes, so, Allie, thanks for the question.

these specific the in the and remarks, growth even bring to bring we continue in to we'll we're R&D down said I can like that prepared and have focus So A not the going lot to done but balance with reinvesting do that revenue so, we of continue SG&A guidance, is, lot so down quarter. of a and revenue to this pipeline Auryxia opportunities. provide work it

is guidance able that our, manage I be can analysis, that to think cash Auryxia give, thing within have that to the the we clear expectation expenses that the and the that's we I concern big going plan revenue. mentioned, we the our to the that strongest

So we're that. very excited about

things the just we've plan long-term think into burn the point not to factor commercial is I right vadadustat success would the investment and two would our that in something be in launch now. a And gotten your pipeline that

be expertise, is would we going having talked the are commercial that don't haven't have the is Vifor the center dialysis and to something now, long strong, in conversations, and major, our on to the going relationship them game with where we to we a plan. focus model there. new center if definitely fortunate the about leverage be right So again, those so investment with the for time, this enough is reassessing leverage of on launch, to we partner We that to But name be this the the our potential be investment. -- relationship back that expect is the so we able dialysis -- is major a

John Butler

And in to that launch we mean, well, the that the structure, organization. Yes, when how out the partnership, point. mean, get of incredible as of it's it do mind that an thought we made the Vifor be was would I with important change I to leverage such with commercial could

to there in It's again, and in launch, case not. investment a we we've of in obviously delivering dust XXXX. our small job continue it'd cash would company yes, launch made marketing ago in but And a be people, We discipline done a I off deliver be, as Auryxia this the approach it alone a So maybe. the is expect investment think to Dave year and us. people I has to a on outcome disciplined we had team built phenomenal budget with very be -- want it's a without, to a to of have a But towards and very, that couple we positive spending. that, the and for mean, But right? phenomenal plan want said, we drive to to that

Allison Bratzel

Got it. much. Thanks so

John Butler

Thanks Allie.

David Spellman

Thank you.

Operator

question our of Wainwright. Ed And next Arce the from H.C. you. with Thank line is coming

line is Your open.

Ed Arce

for congrats Auryxia. operational strong of taking questions on including and the my in all growth Thanks Great. the XXXX progress

of agreement noticed First what question I mentioned those you Auryxia forward you that? wondering communications discuss of And European there? markets? if signed end what's for your have expect for the from a in could me, with expect just going license in I'm Europe. Averoa you we with What expectations you exclusivity can kind

John Butler

Ed thanks for question. the

always is has on we've something U.S. European available own. a and we We small of we to And think our where idea the execute us. European with be attractive there product we for company. again, knew So -- bringing been can this going the weren't benefit is but patients this only a to Auryxia, in Averoa had the

regulatory in risk, us a at authorities, place they're they're little and and important. was at quite very, and a look the don't that we with this that they've just tried now, market And contract I for say consulting bit to on got very downside little successful partner with bringing they're to upside it look put but bit So and for in if a at here that to differently, look working created distraction a little, differently the organization.

us. creates our again, really but relying data there's of purpose patients a bringing living what amount need, have a per stage on blanking upside potential we're for products protection timeframe doing but just Europe, it patent it be than way in where the So market. you time in exclusivity to that they'll of that's Remember, on the rather in is,

significant a but So obviously, for this, there. this to we're necessary. but company, that we on the they is some so they're them the of a risk, are This amount is opportunity there's building we'll as us. I They a we're with that the little, we -- if with as is royalty-based see. taking the happy an focus say successful supporting wouldn't put in a deal approach way as think look very deal upside forward taking and and partner something about EMA Averoa

Ed Arce

opportunity expand I Okay. you March if on there I of And And perhaps wondering that leverage remarks way? I'm if any come think mention wondered release to related, TDAPA. XXXX? on revenues your -- for initiatives I would of in to in your upon is Auryxia heard then brief you XXXX. prepared beyond working any to you're extend also Thanks. certain you the mentioned that in care that the

John Butler

per pieces. given ANDA that I do there's the there we mean, sevelamer, -- manufactured first comment. I this of Yes, entry Ed. volume know it foremost, in focused before that at what of one is to you into was and March look we generic that's settlements Thanks, some think, of very Dave significant that two the analog drug has the of I where have mean -- really much, time but was if quite patient, XXXX, took be there market.

that. in, a wasn't had a profitability Sanofi was but who's the from And time come cliff. they It significant selling patent at And ultimately, patent did it slope. that drug

product that's $X That product. was product was a opportunity sevelamer that. much there time. so at revenue we some here of smaller And have And that a billion

for So make. an the to is attractive product a it they that's financially to of assessment in, bring number have generic manufacturers

a rule, the process talk what's phosphate they But is, CMS January go two-year that bundle the XXXX, we'll made the with which situation in unique of the I today final made clear and the process, appropriate them that has TDAPA expectation. as be the has you they said, process, three-year [indiscernible] they that. But it TDAPA last that as which binders were to clear, that for said more been have we're about in will did they would a and think and going to TDAPA into

how dialysis process, make two TDAPA two-year a data the -- to the about January can collecting utilize add dollar decision come bundled so to they to phosphate of with they're to those a But XXXX. it binders, what means what providers for years see amount payment

from to you treat dialysis to motivation branded provider that but not think a so appropriately, cover up this going doesn't costs a products patients there's if standpoint, lot like a Obviously, with payment to that products their use. So use ultimately. about bundled they're end of they

clearly of drug XXXX course, the appropriately but with switch and XXXX. with an over on the opportunity generics helping utilization beyond over utilizing of to for that is then course XXXX increase there and them to patients, increasing, to us with the work for Auryxia continuing So

to I that how now really, providers some revenue see some rolled with be there's we're So working out. meaningful just dialysis and think, will opportunities there,

Ed Arce

commercially clarify Okay, joined bit last already, to is a in vadadustat I you plan that wanted the what this to If U.S. discussed in right now? process but an question, great. maybe for were ultimately approval, your And then one so I result just late,

John Butler

of patients FDRR patients, is is So focus now for dialysis for the the only.

have launch a from perspective, that have of think where approval they of we'll reorganization put couple leverage marketing yield. from other people, us expectation for be have but tremendous we So organization field perspective, relationship, place amount what that to much for we a to And on a Vifor that relationship field commercial we've now, we to the they with, an the of us really who would add have, what because and that the year, providers P&L focus commercial did allows of last have, the we have probably need in right? Fresenius a we would have efficient medium if a that. small our have and contracts, more and We Vifor successful the directly we're the we delivers contracts sell with late

Ed Arce

so much. thanks Great,

John Butler

Thanks, Ed.

David Spellman

Thanks Ed.

Operator

Thank you.

Our next question is coming from the line of Robert Hazlett with BTIG.

open. Your line is

Robert Hazlett

and thank you the taking Yes, for questions the progress. congrats on

forward more. Looking to

quick for on margins a Just this quarter. question

call, you should I in think we release. some mention you benefit excuse be thinking the goods quarter; termination and COGS into more little there about But mentioned Could how was the think gross it margin? of a detail bit contract me, in a the about it I go cost about this fees. had

and you're and gross Again, about and guidance, thinking Thanks. I costs not the know general? in commenting of on but margins operations expense things in the Auryxia general, just

David Spellman

Yes. for Bert. Thanks the question,

chain. we on restructuring in something release different back supply supply providing been the back We on as we we had supply a supply with contract the had the updates that between aware, So contract folks purchase then agreements each quarter that then. are excess of call a multiyear December, AK-ed the an that of we commitment had termination

We and expect that quarter. in those away, going we charges charges have reversed the those are fourth

still back a you'll -- Auryxia. normal what line, out you'll the numbers, will which But we've the we're normal providing and be more and be much sell COGS will you called of those there as the or So cost just it specific whether a clearly see at noncash expense. just and amortization what within look see intangible much you'll that goods would inventory purchase can you'll what and is take but now that in disclosed, it's go see is rate. that And line, going side, more a of excess forward produce not to cost again, historically write-offs, to be our see

again, those reversed of big excess and contracts. changing really, contract us on flow. excess been about we're of a happy terminations we're does talking those those reworks has contributor about real it And that cash that in this because big, $XX to the And significant million us really having runway purchase we cash save was It now for amount commitments. a

Robert Hazlett

Terrific.

Looking bet. on In of seeking at moving I That's way, all? A Are Dr. interacting shape forward. Only Stein in or U.S. forward Akebia couple vadadustat. additional to great. is form? data couple the on cleaner numbers with a directly from that you -- any questions him

John Butler

that. the to new of things we the So so got that all couldn't he It's the the proactively of focus be new included review, get data into at. him be we'll in of that us the rules That's FDRR. from are internal anything to letter look give the NDA. If part the of is then anything FDRR responsive requests having. actually obviously discussions that he can't is to Part the is you

I speed for mean, to he's to speak think I up I speed, clearly from a don't way. him, is certainly, to come focus want but initial So his up his long letter, coming

seek he really internal mean guidance. the I in wants issues but hand, at to quite that was versed

about more it's think that. I So

We process to support outcome. are we everything can him support and -- will in that do positive we a

him communication on a issues something clearly these welcome. with be having is So we direct would

Robert Hazlett

Okay, terrific. you? up data. the weekly data And for we about What then -- a there's data of in of times additional thinking release that just bit three this does study? study, should the What little expect focus terms again, coming give

John Butler

Yes.

for the session publication will determined. label. be a dose that And for vadadustat data a the in be important right? presenting at we that expect or we study mean It's weekly I basis do a in with dialysis So to having an that times feel three study. be we'll scientific in It obviously, our patients, the is

in ability So U.S., drug for just the helpful that have a the a compliance to ensure them dialysis be on outcome negative that and their for having even with very in dialysis Europe is can patient patients. the deliver when we and for outcome providers positive option is another

commercially important important, it's it's I It's and an so think it's too. more important of And and patients, giving option. physicians for

is completing, we data that year. that that, this So presented be do expect study will and

Robert Hazlett

the you to And vadadustat Vafseo kind But and of can any like just moving the one a come terrific. for Okay, think Thanks. would label it. formally, sorry to but in be some I authorization forward? kind we're back for you as Just what you I more can this degree, would more talked of a do, broad potential look characterization as helpful. I'm provide bit little maybe about to EU just,

John Butler

we that by patients the But of authorization, ahead we're kind the a that's are go of at with. in alone. least eye way mean, either, obviously, would a at through I you when want There's FDA, So commercial talking outside you it's I'm and as nothing very expect And work in are appropriate of what until kind in obviously dialysis that. the to I and SmPCs. we I don't a think that looking there. can of absolutely expressed look I the have are from handled all But with at obviously, get very pleased on a concerns label CHMP focused those we those about marketing it label

SMPC. anticipated the So

no So it, the seen what we'll final based so see have I've a perspective commercial but we on have I far. concerns when from

Robert Hazlett

interactions those until formal said to clearly sense going a along commercial Terrific. would obviously characterize get lines, there. the just to more with that one the And out of nothing of parties But status additional pretty authorization. in EU? happen I'd temperament you You folks just is love Thanks. how the for

John Butler

important very, process that creating are -- opinion product we parties who get Having very and It's have deal. an a parties for more as active us, clarity And having and us a that and an for seeing value-creating active maintaining very interested. Yes. outcome that's that's versus authorization creates and multiple for for No, takes with And through it dialysis yields non-dialysis, you that time bit if value was to process. more time, the it's to the positive a well multiple obviously, little dialysis and usually very process. best getting usually the is spent. us CHMP the ultimately, it's process

this how with is pleased process So forward. moving we're very

Robert Hazlett

Congrats progress. all for the Thanks that. on

Looking forward to more. Thank you.

John Butler

Bert. Thanks,

David Spellman

Bert. Thanks

Operator

back at I showing will call time. remarks. turn Mr. for Butler questions John no I'm to closing the now any over further this

John Butler

thank attendance this your for and operator, Thanks, morning. you all

of few we're excitement celebrate commitment Auryxia hope expecting I got World a a quickly continue today, day of revenue very $XXX to million Day in I our the to of our growth We're forward we drives patients exciting for this sense us to drive to and want from While you net product to developments really just revenue summarize call. deliver million. expect going XXXX. $XXX to and Kidney every

from a received marketing for vadadustat couple CHMP of positive the authorization in months. a anticipate and We opinion

decision regulatory anticipate for a ACCESS to a expect the We vadadustat commercialize Consortium Europe. in We engaging countries. partner

with decision in vadadustat that will population. patient with an We the a the anticipate broader a expect FDA. FDRR process UTHealth on We study ARDS initiate

talking the And pipeline we look to much as compounds progresses. and forward development vadadustat our HIF-PHI more other year for about novel

forward for to and be Akebia, a it will a for Thanks we us, exciting further I joining it. look year on an year great updating again day. Have you think, So busy us. very, very for

Operator

gentlemen, your you and participation. our for does for today. conclude Ladies conference Thank that

may disconnect. You now

Akebia Therapeutics (AKBA) 9 Mar 232022 Q4 Earnings call transcript