AKBA - Earnings call transcript Q3 2021 | Akebia Therapeutics, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Akebia’s Third Quarter 2021 Financial Results [Operator Instructions]. I would now like to hand the conference over to your first speaker Mercedes Carrasco. Thank you, and please go ahead.

Mercedes Carrasco

Thank you, and welcome to Akebia’s third quarter 2021 financial results and business update conference call. section press third issued that quarter available the a X, Thursday, release that site. on our Web detailing financial Investors note release on was November is Please our of results and

For your call be we on available after of Web shortly will site also our conclude. a convenience, replay today’s

of Dave Officer for Officer; Head Dell Financial today’s John and as Joining Burke, Chief as R&D we me Steven Butler, our Officer, available Chief Commercial Medical Spellman, have call Chief well Dr. Executive who’ll Officer; question. for Chief Faulkingham, our be

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

is on discussion annual most describing well Xth, November revise With like as forward-looking included introduce the any original to call. our or issued John financial that of SEC. the this risk analysis as not management’s our reports these and information sections release The these recent of factors in results we required and of except press would Additional we obligation call quarterly and only filed on as statements date And undertake by Butler. update the that, law, speak I statements. with any the as this in do risks of CEO, to

John Butler

Well, us within date the joining Mercedes. months today. vadadustat. target we’re for Thanks for everyone Thanks action PDUFA five of

anemia both dialysis. and chronic disease hydroxylase on HIF-PHI treatment the inhibitor, for currently to or under Our kidney of by investigational FDA patients, not hypoxia on factor, review the in adult dialysis prolyl inducible due

approval. or will yet potential a approved. about not regulatory subject are Any is the As to comments its vadadustat we discussions of vadadustat make reminder,

for pivotal and about to potential for lives kidney continue approval oral review which be the on our of people have is a team and a additional we increase and purpose a That we confidence the Developments of quarter path of delivering momentum vadadustat, this just we by cycle a past completed X this for data weekend. excited during potential step a our motivates completion gained launch Week, a prepare living for release have opportunity and to over tremendous for people including and to An launch. importantly, ASN impacted has Akebia to towards for product are what the our therapeutic the the FDA's catalyst market, that Kidney success We first-in-class better with bring novel Phase disease. global mid to disease. vadadustat approval as

and progress educate to made including Our CKD team about physicians, our preparing anemia also vadadustat. organizations due has medical successful to payers significant launch, teams’ dialysis and for efforts

excited potential first-in-class than anticipated are We US. few in the much about just This HIF-PHIs the to is market a months opportunity we be vadadustat's ago. a larger

Of over by course, can The ago significant MTPC globally just believe launched well. impact was product year Japan. in we a our a have as vadadustat partner

Agency. partner or Otsuka, our month worked We're with to agents to share. was the VASFSEO to more marketing of grow continues share closely ESAs. anemia last with We in authorization, erythropoiesis-stimulating HIF-PHI proud are encouraged the market Japan, intention prescribe And Japan submitted that over in along HIF-PHIs market an stated the have collaboration the which to on have Medicines European physicians that European

begins We as will continue EMA the process. to review support Otsuka the

in hospitalized study progress. continues syndrome ongoing have We or severity as investigator potential University to of COVID-XX patients therapy of explore due prevent of sponsored Texas who distress acute development Health's for adult continue to been opportunities the vadadustat. and ARDS vadadustat a to lessen to respiratory

are on we initial XXX preparing enrollment decided has successful PDUFA With now, We Health this committee, beyond targets I'll the to approaching. in our from UT now opportunity. consistent. that monitoring look on this and and to to In We and an dialysis big on few when Dell confident forward data let States, are they've to updating approximately of date on There launch their Right their launch with details due I'd anemia. market data it. patients, the treated these the study as to for are ESAs the But first, Health The like a approximately preparation. you an me very for data to is completes a support population. manage dialysis UT feel of study picture program Phase support with opportunity surpassed. being treatment vadadustat data. a clear fast XXX,XXX approval the XX% CKD start our moment, our words are focused share for share their X patients ask as anemia United some our a expand patient

with and vadadustat manner Phase steady compared hemoglobin agreed X.XX MACE once vadadustat bound increased darbepoetin a a gradual target of in and that, In Our and hemoglobin confidence the US Europe. in data to X.XX, and to a of interval hazard ratio X of of daily ESA. of well minimized safety the upper analysis, alfa overshoots dosing demonstrated an demonstrated X.X X.XX in below the

infections, into of of receiving dialysis, ASN dependent increased over data to the dependent Week. is means the ability was to or seen market. the the daily In dialysis the risk with with importance new dose in and receiving past, dialysis with Our discussed dialysis at on of infusions presented program. to last target was ability peritoneal England hemoglobin treatment patients once also that won't data thrombosis the The of for showed seizures was segment titrate access presented regularly The vadadustat peritoneal demonstrated a vadadustat Data we've dialysis fastest dialysis anemia to centers vadadustat data CKD ESA. which Kidney darbepoetin. of overall profile dose growing PD for of of Medicine at come in home similar The dialysis ASN the additional safety events, CKD have of the week equal adjustments patients thromboembolic published serious dialysis and demonstrated in patients that of to range data rate in no presented the fewer what into time. Journal

over the $X vadadustat market for We establish That opportunity alone. of anemia positive there the US of unique support all to the proposition including of patients patients vadadustat in patients patients. With help oral on CKD, potential US with patients compelling in about Our due we'll for in standard support the new non-dialysis would these benefit to CKD due on encouraging address of to vadadustat the dialysis use non of as significant. dialysis with million for to We CKD. a are have number cautious We data potential a we is anemia adult believe dialysis needs providers dialysis approval, broadly label are profile receiving rapidly with to vadadustat of potential the a both half and unmet and broad patients to extend to value represents CKD. of patients. the the better believe care believe and that risk supporting home impact offers data the remain The billion looking growing to vadadustat anemia treatment these patients. of

the put extensive respect population. a non compelling in we we NDA However, believe and dialysis data package forward to the with

the And decision with continue FDA and We Dell pre-commercialization pleased our March. to in to activities. that, turn speak let with look engagement be who forward to their with will our to me

Dell Faulkingham

Thank you, John.

like dialysis, will well. of opportunity are look focus important for the we within to share deep are in commercial picture in I'm it's activities what as believe although, the and We approved. is note preparedness if the we launch non-dialysis planning in Today, that we'll pleased to vadadustat parallel opportunity on

a objective opportunity. the to for prepare launch successful that maximizes vadadustat is Our overall commercial

energized is team the Our to first potential to be by market.

a market the needs standard address anemia billion with approval $X highlighted, we vadadustat patients care of of on seek the in the of oral as have we rapidly And to CKD. potential unmet adult represents will will treatment a new US to John half That over opportunity US As for alone. due establish dialysis. opportunity the the to million of the

Our launch cross-functional team from robust support plan. a partner with Otsuka developed has our

dialysis needs standard on care to in access from current of for the investing vadadustat at are due the patients CKD, all We broad differentiating aimed providing unmet approved. pre-commercialization addressing and activities anemia with vadadustat appropriate of if patients

to rapid to our access to for adoption up with distribution XX% will US be which and treat patients. of vadadustat as providers, dialysis dialysis secure Pharma look agreement The we relationship certain Care other Vifor Fresenius Specifically, together facilitates critical. Medical

We dialysis is unique believe access market Additionally, Akebia already to to positioned other when a appropriate also intended and adoption that rapid focused a nephrology the and TDAPA. of likely the to in of sales in engage the providers. and payment clinicians DaVita force is community XX% our the reimbursement with providers strategically to the strong on patients. dialysis dialysis well referred dialysis presence by as due remaining US is to is encourage important This model adoption to kidney bundle that therapies US innovative has an add to

under approval and Our TDAPA is for will of from the vadadustat official from team to reimbursement take preparing which for TDAPA, six will date for designation regulatory extend months designation. approximately years two we anticipate

in been our product. space Auryxia, position has leadership current commercial Our established with the kidney

healthcare providers, an experienced the have We knows payers, team that and patients.

this the a to information of view to the been possesses what commercial beneficial our team launch believe in we community deep field unmet of vadadustat has well highly Our attractive plans, opportunity. CKD and related informing needs as our as insights be

to support impacted our been COVID-XX to US successful continues component grow. a that, they to is Our dedicated key on to by second to disproportionately remain is want the as commercial have product launch. who team the a and Revenue patients Auryxia pandemic. team kidney ready With for a recognize I

patients. team new to encouraged and views are the Auryxia’s and find with commitment market strengths of with customers our applaud to connect We and how support tenacity the ways

again, We approved. vadadustat Auryxia annual revenue And foundation to continue growth of expect deliver launch successful for believe to XXXX. is this an the if important support to

call discuss financial Dave Now, I'll over turn to to our the results.

Dave Spellman

good Thank morning, everyone. you, Dell and

the Dell supply approval, vadadustat. mentioned, of potential for preparations believe existing the with We groundwork at As footprint John commercial working our launch time are ensure to commercial we’re pre-launch we and for appropriate approval. positioned advancing subject drug to having well and laid

for performed is vadadustat program is related are for here in It with vadadustat expenses directly activities to that respect currently clinical program. to since revenue the was million XXXX successfully reflecting quarter Phase with to X we financial quarter lower our million third XXXX, of revenues Total for quarter third global tied compared of the because explicitly revenue work Turning our to reduced the $XX worthnoting our for have collaboration is collaboration program. engaged revenue completed on results development the vadadustat starting the and out $XX.X close revenue. Collaboration tapered.

Auryxia caused challenging product for XXXX For quarter this to the very over of the higher realized million proud increased per our XXXX. growth of the third Akebia reflects The payer is increased is in the that last one-time compared three we X% include market net performance, patients for we is current serve. net quarter $XX.X mix. some pill a revenue with $XX.X believe of team The true-ups has third COVID where reflective revenue million of and what previously is a than mortality the years

to expenses. Turning

had worth some but expenses items review time our that all noting. a You've to few are

effectively cost footprint, of chain this already products would to to our incur. other to our X continue supply chain initiatives, studies than week prioritized commercial thereby, a work times supply existing a able and in with on build vadadustat biotechs X value We're spend out expenses most research. more commercial including costs significant have build avoiding for We spend without prioritize our our and to creation Phase because have invest

As shared a of vadadustat collaboration costs the reminder, across consistent our with chain agreements, are certain partnerships. our terms supply

million bottom compared loss For XXXX. quarter million net of quarter third $XX.X XXXX $XX for for the of our the third line, was to

and Regarding the third position, ended cash, our for in cash capital with we million $XXX.X available quarter equivalents sale securities.

which stock of was quarter previously third third $XX.X program common disclosed. from quarter the aftermarket cash of proceeds million under sales XXXX, company's offering of net the during balance Our includes

in prepared were plan there the filing which We next ATM current would our clarification guidance on the call, from of the last milestone milestone be of the sales operating Otsuka be US. vadadustat For which US of and payments be provided that Subject our provide third the beyond has Akebia, worth $XX revenues, to US are tiered if to the regulatory XX Otsuka second the months. to we resources sufficient will with XX-Qs. of no are fund On receive to for milestones, are to Otsuka, The given to approved believe agreements repeating. to cash the on launch right being Commenting our this estimated on least at in approval to nature milestones for in terms at clarity, HIF-PHIs between not the and these succeeds quarter that the payments future on time. vadadustat vadadustat Akebia million. collaboration we require Europe, our up

there significant potential are Additionally, sales milestones.

part of pre-funding, up maybe to these to with Otsuka, existing of which accumulated funding offset a milestones arrangement R&D today at As used stands $XXX million. our R&D our XX%

Given that partner up the million has assuming eligible no delays should we are to our in review their we receive filed milestones, in to Otsuka process. out MAA now that in Europe, MAA $XX point regular

vadadustat perspective milestone that, million of the its open terms of the whichever upon our agreement for In questions. line has with approval inclusion with license in right $XX addition, system payment first. Akebia consistent will TDAPA we and US is Vifor, With or the Operator? in receive to payments the

Operator

from [Operator Raymond first question Chris of Instructions] Piper line Our with Sandler. comes the

Alli Bratzel

This this Alli Bratzel is taking the for on question. for morning. Thanks Chris

vadadustat coming community as on presented What there. So are how kids it kind to be ASN I data characterizing of or presented docs profile? from Maybe relates off some viewing nephrology helpful? would among meeting any of guess the you really the to color are differentiation that vadadustat and weekend. feedback about this getting especially additional the I and guess comparisons just analysis set feedback the

John Butler

just presented weekend. Obviously, the vadadustat was data this

I immediate think we'll it's them, and New the learn I And So very digest of kind Journal out feedback. there England as be are papers people think more.

to kind are generally it prescribe Jennifer think fill presentation probably that. expectations expectation ASN was almost into physicians I extremely of to and also a was reactions HIF was HIF from they really point. of likely around think and Robinson of I meeting XX% their prescribing there And to were speaking, at that XX% encouraged see some the on I Spherix, presented the said fully at physicians

data data I certainly a were confirm that? roxadustat of the but dialysis kind think really in confidence used And were -- daprodustat differences So our again, not the safely. make effect are concerns between think that and a Quite can products any the starting data that the the I class seeing with saw to us in the products only and other there's part Steve, that dialysis, that are to with non roxadustat as path daprodustat I that frankly, around they in gives forward. there's these issues seen be for more felt people think comments did the our to about approval, well. you serves want

Steven Burke

No, I agree.

the if hypothesis in our data target the people these think comfort are you appropriately that daprodustat it can you I taking supports drugs safely and hemoglobin. use

John Butler

XX data I forward all dialysis, the the mean, hemoglobin remember across they looks non for -- is XX, a we've US that to studies, a XX and was we overall dataset that's population the the remember extraordinarily daprodustat XX -- to see FDA had the a of of you the did target daprodustat data patients where that where in to targeted. our set XX the our target that like to XX put

that I once again, that our data we is that the So We strong think us infections the seen when imbalance dialysis papers about presented England great that presented and and referenced don't now we've now while only you more there events, kind there. some path of the board. my serious around the see on our And what think And gives this center just concern only forward. And remarks, seen then incredibly I what's presented confirms us data more we've think obviously really much in dapro AdCom. We of the but own that were data so encouraging presented been contention. across and supports Journal New confidence I in that the at seizures thromboembolic issues in discreetly. we that was gives that,

Operator

of question Cantor from comes Young Fitzgerald. the next from line Our Alethia

Alethia Young

it and of your your update, that said One, maybe past I of hitting the end. non in kind And get suspect their that. change part. just trial, though, may your sounds your in the panel, to there is, just optionality, any Maybe as on I dialysis, then have but I on like continue to of It non-dialysis. seems perspective having now one a the kind think if of a mean, I that then that I know you kind that's from evaluation competitors share of confidence you lock question competitor a you kind dialysis potential that relates on recently the conjecture to even kind want the get Thanks. to out couple your little they on perspective their calculus the me. dapa, I of Does commentary bit heard what but another with like in even feel to of wanted one. as with collaboration not reiterate was of kind kind of more And guess, to they guess, Vifor about market?

John Butler

of So we the first HIF PHI on the in the this at front that’s only point, the question know I panel. FDA. that, are on

path. while us FDA the that open has to given So and for one, any panel are not we'll preparing a certainly indication have we a

time, from which the But to have expected said continued and always they that, expect that them panel, allows don't we So change be has I we'll be this think ready we've one mind. their the a to message for FDA one. at opportunity

see kind So progresses. and as wait the just review of we'll

we to our the to in around what ratio This generally as the to X.XX. bound referenced of target In is hazard patients think, US ratio, had hemoglobin targeted So XX mentioned, path outside when just own non-dialysis, higher I X, studies. data I to hemoglobin upper variable, hazard is, Recall with you we've continuous ages a as is target the level. which XX we the a on at US had and for us US, if were you US us X.XX, been in a looked the patients encourages which had saying really an last in at X.XX using a you daprodustat XX, patients question, answer XX managed of we I’ve over actually forward. our and

that they result increased point. their kind population clearly risks end basically their primary hit So not where was really an showing for daprodustat of overall in cardiovascular confirmed

So us, us that as to things and panel. this gives with benefit were isn't which elevated risk. And panel, -- more the here see risk, class goes really They particularly difference back really treating any look again, didn't is the for this looked recognizing at vadadustat the of an that what outweighs go there events, that you it roxa is patients much there treatment unmet FDA patients And that's that confidence saw need thromboembolic broadly roxadustat FDA simply cardiovascular there. recognize that serious an we that, the on the where options. importantly, in benefit infections focused risks, when it and at the seizures need

So we'll see.

to guess, the rationale seconds said, -- for to of Vifor I we dialysis, It's what ongoing. yes, the been FDA. with I planning was engaged engagement. three we is comes we'll and continue forward March then XXth, that as I had to by As of pleased their the And deal. we level are But to. it with down be look said, We're

those add Vifor for access patients. is Now don't to to you Fresenius we're that? we Dell, have important an it's us. opportunity that very I have there that's know, to We important to And and of doesn't want be planning to think anything change. two first to think rationale

Dell Faulkingham

of for market and the gives about certain I to patients. providers the access dialysis excited Vifor us us that think be And opportunity dialysis. US XX% the FMC to enable in other exclusive dialysis and We're vadadustat does HIF the

at a launch about think and are we do excited real it. for opportunity we us So that's

John Butler

in wouldn't with data. our mentioned disagree are you cautious, as optionality very Alethia being there. about we of I And being talked confident We've certainly non-dialysis you so kind and

reflected. think and not is on is reflected, And this get more a you is a opportunity when or be $X year dialysis at dialysis we for first look valuation filing that prevalent in date. I isn't depending billion today, this to

a So we us. opportunity for think is this phenomenal

Operator

line the Our next Eric JP Morgan. question Joseph comes of from from

Eric Joseph

follow-up activities. to wanted just commentary some commercial I on the of regarding

And support you to sales any with extension how teams sort in you're personnel Difficulty] over sites dialysis non US. anticipate [Technical there? the the launch currently to then, Auryxia for in should think, or of think in I so Otsuka expect dialysis, optionality do expansion non-dialysis, support MSL or how what Specifically and from support I we vadadustat as yes, coming you in

John Butler

of faded part your last out. that there second question Eric,

Eric Joseph

and of you sales be If how approved in sort we should versus from Otsuka? contribution sizing force non-dialysis, support are MSL thinking Akebia the about and to non-dialysis

John Butler

the benefits having place. organization one of a commercial in already That's of

As we’re that to detail we vadadustat going get But give a little from to do Dell, organization. to have leverage there? great you want

Dell Faulkingham

market if we the field know, focused Akebia move we are towards going have And that still both launch receive have And and in here for really with to largely the footprint, that opportunity. leverage a even market dialysis. MSL point we have, we think we have key the with Otsuka the to resources in can being to launch in. as feel would our marketplace. really is of kidney approval potential support look their sales in vadadustat. at voice be and a we this an in And dialysis, the at We indications, you an medical first we've we the experienced the footprints where you leverage opportunity field of non strong at share incremental. commercial need in make as existing sure like come exciting this if we And looked believe is well is as and as to what Certainly, nephrology partnership what needed a we current established our field Auryxia. we've that's So sizing the to of team reputation team really

need we add we're in So feel create position launch. successful we great to a to of infrastructure one moving this a won't and like lot where today forward a is really

John Butler

just has Otsuka things But launch. And sales Also of sales force on one our focused outside is the dialysis does detail the on what around been working the partner. of a working particularly focused Dells, force is on, the who dialysis. we're that's in is and great

we're in we all. we position that population at So to without larger that a resources access build great that get if expanded to those have patient a team having

great And you it some position is So closer to think detail, really get I to be discussions a finalize we we'll in. be update those as able we around kind Otsuka the of as of launch. with to

Eric Joseph

million a the there follow-up your non Is you milestone and could. the to Just that I dialysis? if in considered outlined that remarks, XX a respect tied certain to individual approval Is in prepared segments? amounts the both US. With milestones in dialysis

John Butler

and So based XX those we non million XX first million are dialysis, disclosed is the market. previously being is HIF to that have of attached on attached dialysis that a to and to

Operator

of from comes the from Needham Serge question Belanger next Our line Company. and

Serge Belanger

First runway? what does prep is talk how one for product? into the that assuming commercial months TDAPA have the additional readiness what maybe the growth? on supply. now settlement we reimbursement Auryxia, recent does vadadustat, a for see your terms since has Could you process, launch your talk then aspect, of And you IP outlook approval key clarity timing? about late been in six for is Maybe the the And that secondly about March. recent given that launch And get just with change driving on investments product on the play in generics,

John Butler

product supply from have launch. So a for perspective, two we drug and suppliers API two

chain made on. our build the into early to redundancy So we supply decision

we'll at the have Dell, available a process for successful And want so within kind about TDAPA fast comfortable launch supply talk market. like? dialysis you of the we uptake very and are that very adequate do to

Dell Faulkingham

we regulatory for at approval apply to TDAPA. mentioned, you As expect

to As possible as approximately six the approval. you launch in to as said, after regulatory plan process take soon we months. we But expect dialysis

there When have clinical educating the we TDAPA and period opportunity needs place. that anticipate vadadustat starts. be first data the for all don't we ensuring the unmet about waiting on the So in be you we on want the patient out to until to to market, details operational and think focusing

once or there. about given think to TDAPA believe will another the our will revenue timing. that therapies, So TDAPA to of dialysis be created vadadustat vadadustat that new the we ready ramp, certainly rate in we encourage Obviously, timing you adoption of of certainly providers adoption to dialysis begin ramp be go linked said was way, think of to important that as for TDAPA will we be

that's vadadustat our for in dialysis. So plan

some strong the But where hybrid more really has of it's to a the a market think As think are this challenging really Auryxia resilience are on and dynamics. multi-channel The companies I approach adapted been significantly job to access as due binder and team we continues most I I team far mortality engagement given really been proud goes, that's be and year to is overall, as so has down has space think a we are demonstrated But our difficult. providers promotion. experiencing, really And focusing market. phosphate overall market disproportionate and the this in certainly the then healthcare to done challenge. non-personal

believe market moving the continue expect revenue to grow we to challenging be We continue we but forward. certainly Auryxia can to net

John Butler

in And in the the product. of XXXX final just because which that could for settlement, long there well. the mean us an be we is products opportunity and moving payments Auryxia, term having pushes payment market confidence to part don't into as as think we it's particularly a opportunity just of system, out the the gives doesn't bundle, to can PPS for that opportunities phosphate -- given continue generics continue important to end opportunity binders the to And in great think grow us ability till the with great market that business up the us creates us have bundled enter for I give XX, of multiple XXXX settlement, X

non-dialysis, contribute the for quick So we that the from us And have significantly if of have while confidence made to supply for to ramp position But uptake than both is will in the speed expected we in But perspective. entering clarify, clarity, think one support have we've dialysis. we any in place But we will slower that the no then. still under for comfortable in we non-dialysis curve just and sure both be comfortable one thing quite are position. area be patient to in to before will supply just cash populations. a dialysis launch it's with dialysis. We a is great do a a

Operator

line from of question Our comes Morgan David Lebowitz Stanley. next the from

Avatar Jones

Jones is couple David for questions on This from us. morning. A Avatar this of

is, over look first And of there? expenses reimbursement next you the potential of potential can and we Medicare time The XX the resolution color new developments a context for D launch? for lines at Auryxia in months on any provide should SG&A Part how secondly,

John Butler

do to Dave, want you handle?

Dave Spellman

Yes, I think.

with for So, times, SG&A, that to few the think proud the in infrastructure that think perspective, to largely, vadadustat I Otsuka expense of largely just the some that need talked I support have we're we've shared that expenses launch, is place team you'd build build the vadadustat really a about perspective, that, personnel in brand. But at to an place. from is a and the we like successful very of And team built. a in we've we terms from team would be looking

John Butler

IDA Auryxia, few to might And have for coverage don't incredibly focused D an that to for Auryxia. CMS think coverage indication This have have coverage question a difficult on know disagrees second against we this out make. that the your I the the on you we assume seeking very for We need announcement weeks where I or unfortunate us dismiss indication. put Medicare coverage that it's should was ago, a we and And that the have covered. decision was a did where for Part lawsuit seen IDA that access product patients drug, were the and for was we CMS be didn't

not the had Congress, IDA. get and we're walk the on which preliminary made covered that we that. to were an side, market provide lawsuit. much where And members engaging from -- we that have we're lot dialysis We we've to working it. to so Obviously, But us, the for legislation space. But injunction; work so is hyperphosphatemia, those answer there's in spent for to away from for it's for grow get introduced more by larger Now, and time we to coverage do on going patients with didn't away decision or looking we for a continue patients that's that. opportunity coverage recently legislative we the to walking resources difficult the very of so get to for been still far of

that ways walking part a opportunity. stayed it's from So we're population. the team his and can IDA. to revenue, optimize away IDA smaller access the access population Dell small, the are working And was to the much continuing that grow private-pay though then, way, on hyperphosphatemia even Auryxia and and not for of product patients for

grow we to and in opportunity earlier, is. legislative will focus We that But continue Dell our that's for find hyperphosphatemia referenced to stay the time, fix until we expect have it where that, a some [indiscernible]. as

Operator

Our comes Arce from of line H.C. next & Ed Wainwright from Company. the question

Ed Arce

me. couple A for

place regard around than in be non-dialysis the that footprint and many of -- in in that how your you And largely sales remarks incremental the overall on approved, And be I early many approval. the do few months that. even and if of what think the commentary readiness much is investment perhaps prepared being now the exactly were right you would discovered, teams do have reps What today? you marketing wondering you wondering discuss that just secondly, market there clarify you on have could remind of Firstly, areas us, ancillary overall support then if how other and I'm a even sort and could and the see MSLs also. staff if ahead expected activities sales would now? a on comment and ago. was training just going anemia in larger necessary

John Butler

to expecting been the But Ed, is how Dell the be an the have $X the ago, be opportunity months product billion for we we've for to the thanks That's expecting first. years. We've The and to first-in-class market, pass a then it second for market still much introduce the market second. the unexpected we're is to of expecting first question, to opportunity last so been I'll opportunity your planning. -- haven't to size second opportunity. few to questions. the market were opportunity take I'll the be the HIF-PHI I that the X product and been and

First we footprint about and to a larger can us been entrant, much you a at training opportunity really a And for with, Dell, a we think second opportunity maybe readiness. market start is talk head had and least than considering. or a year great of the so over

Dell Faulkingham

team which our of have and So plus we about currently, XX and so is MSLs, teams. small management team, access employees, people, XXX has Steve, into of reports field-based have about team. a those, XXX a we -- medical our The commercial sales

the largely the certainly that's is in be now dialysis launch as right well. Auryxia of will and vadadustat, to non-dialysis group that support with So in and working able

to that mentioned, our in with we there details place launch have of do able be to in we working to to partnership great partner, that if Otsuka, As that. where out any resources we're are need that that's incremental and the non-dialysis, it's

be As far PDUFA team the functions around from space. is sure as And our I working is make perspective, date has to marketing medical readiness about materials at activities, this team that and talking our a Certainly, to across different certainly, should ready education say, interactions. the started in to really our we'll full. training access sales readiness market team have pre-label a affairs launch or

we're So full pre-commercialization feel team. to approval like we We'll in at the and activities. certainly be full with ready go prelaunch

John Butler

the nephrologists is team, limited do. incredibly we of idea the towards team the an before medical those challenges educating up commercial run mechanism, we anemia the mean, they of are in management, approval, very have HIF, on launch. the But can affairs I as what important

physicians given differences products as three are is interested sets that of And critical the going medical it's learning about success. educate in out particularly launch important, them for different team critically to well. Of be vadadustat course, data, that can data on the those really are that if there. Clarifying

Operator

from Our the next of question line Hazlett BTIG. Bert from comes

Bert Hazlett

Have do all this application US? been in the that expect busy terms bit. calls and you we itself, just But sense the of regard has dialysis addressing on morning. data to only then It's jumping progress. been if of Europe, but -- with morning. application regard types little around Apologies timing the the a give do in not issues a the discussed you addressed this PDUFA first all, been of non-dialysis any same in to reimbursement to the with of them process and And in patients secondly, the Europe? be Congrats

John Butler

Europe, want review was application but the submitted and different the countries, about validated. talk assumption in on. differs it to working that's been I Generally, the a for So is mean, do you we're reimbursement? has the so Dell, timing maybe -- that XX-month

Dell Faulkingham

some are them because on treatment I and think important at there'll differences looking as we basis. we of and that more. we'll the the an earliest to European Germany characteristics, the sometime follow expect of Europe are and more by-country individual different for countries learn earlier and U.K. quite to Europe, reimbursement so larger after. Certainly, to be in of be process, Italy most a launches, Typically, the structures would in and country-by-country launch, patient regional But once receive certainly more to really we the update be approval, reimburse. Spain France on and you with the side

John Butler

be obviously, that labeled be. expectation to But the -- same their important that focus or it's I so have I approved was don't an issues. roxadustat issue at we of some will standpoint, the And they'll we really leading MA, exactly look discussions certainly think will Europe. an know with haven't from where in I note Otsuka mean, the and

they've they've had, challenges that the With labeled around those.

in dialysis, maybe I very, again, kind well. confident confidence have totality, as we more package there. data again, in our -- about in feel think certainly in very or think Europe I also, and data its of the non-dialysis we -- than when very early in So, But days

Operator

this And there further no questions please time. at John, continue. are

John Butler

of is is in March XX process, The Akebia. next a This EMA, at time exciting Thanks, late its Myra. Vadadustat date PDUFA with vadadustat for the in been MAA a submitted has FDA to Japan. review and year. busy set is and approved

on living with remains to focus anemia a anemia novel comparing Our on disease. engaging look review great we to in patients, forward FDA vadadustat's therapeutic Have in we due progress. NDA, to continuing kidney a remain to for in CKD the a you forward potential as We -- of bring due engage people treatment our first-in-class confident chronic for dialysis updating our market to day. to and the look and with oral to

Operator

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

disconnect. Have day. may You now great a

Akebia Therapeutics (AKBA) 9 Nov 212021 Q3 Earnings call transcript