AKBA - Earnings call transcript Q2 2021 | Akebia Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to Akebia Therapeutics Second Quarter of 2021 Financial Results and Business Update Conference Call.

As a reminder, this call is being recorded. I would now like to introduce your host for today’s event, Kristen Sheppard, Senior Vice President of Investor Relations with Akebia.

Kristen Sheppard

Thank you, and welcome to Akebia’s second quarter 2021 financial results and business update conference call. Please note that the press release detailing our results for the second quarter was issued earlier this morning and is available on the Investors section of our website.

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

today’s Spellman, Officer; for Executive Dell Faulkingham, Chief me event Commercial Butler, and John Joining Officer. Chief our Medical Officer; Officer; David Steven our Dr. Financial our Chief Burke, our is Chief

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

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

John Butler

you thank you, Kristen, us today. for Thank and all joining

stage us. marked an half of for and the XXXX for exciting significant The ahead position, first have and year has by for strengthened opportunity that setting vadadustat, Akebia’s been catalyst-rich further milestones the market potential

first-in-class due significance forward footprint. and both, kidney We’ve all force tremendous vadadustat’s vadadustat. of of want and action use, in the patients regulatory for both subject time leveraging and kidney the dialysis the a exciting XXXX. X vadadustat and to novel patients England achievements together, chronic the positioned NDA Medicine, oral one therapeutic in this were filing an in anemia Akebia, results Journal closer with us with a on quarter, these as we time for currently a March the achievements acceptance on is in dialysis, I vadadustat, course, its anticipated. to And, these This we HIF-PHIs data Auryxia, all disease, our believe adult of expertise the U.S., of date of and approval. target treatment adoption Putting dialysis, is vadadustat with underscore approved have that is clinical this recently, global During our PDUFA everyone and available and commercial product, of the the opportunity to believe in which a X commercial sales Phase want strong comments our to the and than our we of are community launch its remind why established look of we potential really ahead which also market a broader spend I us, to CKD by New product, treat FDA as for some is the of more not vadadustat, program, anemia bring today we for and disease. program the morning the regarding nephrology-focused to to our all believe clarity publication potential upon this our step are global for vadadustat no highlighted existing having Phase development originally reputation there due in of of living to of XX, my launch opportunity now

erythropoiesis-stimulating dialysis of new XX% continue CKD profound. on patients States, overall for United in is with people a agents with there CKD. health We vadadustat prospect the this group a the vadadustat’s due are living potential therapeutics with treatment to of with in issues. disease. anemia a approximately or with we’re And ages. to will class begin. of Approximately let’s lead this a ESAs, as their help and disease population is significant this strongly anemia. a The believe of Today, patients as impact being So, general, having the to excited number patients that grow In manage treated are XXX,XXX

symptoms with fatigue, to addition including anemia and breath, left well-known shortness dizziness adverse failure. and complications, the severe such of large been leaders has associated non-dialysis Well, more key the hemoglobin development ventricular hemoglobin cardiovascular company’s use heart demonstrated target associate of the another peer FDA’s These congestive of the are In as differentiating hypertrophy level. their not were of data, our product outcomes, in context disclosed dialysis Multiple vadadustat risks overshoots event that their there and data. ESA and above newly both and reviewed X the the risk increase of on believe cardiovascular outcome under and data speculate opinion Physicians we studies their HIF-PHI increased have patients. with the with of and in speed their for review for we concerns and Phase or will aspects raised adverse program. recently global associated important company

an the NDA As FDA, review in world. the which my and actively journals public most I’ll comments is reputable fortunately, the vadadustat of, data, it’s limit abundance there’s our in published at to under the one of

has team done our Our publication great a plans. on executing job

darbepoetin vadadustat vadadustat increased global First, and a also data compared and minimized The in once that hemoglobin steady showed clinical to our overshoots ESA. dosing data X alfa hemoglobin show Phase manner. daily that gradual of

and that after regulators both, undertaking, of non-dialysis dose analysis significant plan, analyses, designed regulators. pre-specified This entire to treatment that the number goal on and a We approach starting validated dialogue was pleased Phase a with and our to details very X been the years. non-dialysis enabled the including results with FDA in non-inferiority extensive dialysis X both, European programs, statistical global we’re encouraging across it’s the this dialysis in of the highlighting and like Phase design remind also was of our see for programs. both, this I’d our program, you and very in the us And the have our align studies to used it margins.

voice transparency. in these of key entire continued Akebia’s our have publication. global in medical Steering for community scientific We but have to Independent and continues opinion our also doctors We’re chairs of to speak the support publications and the data the Journal Phase Having Executive objective, community. broader New program, is tangible be program publications PROXTECT, ensure also commitment validation one the our the Feedback of of as of believe the leaders interest from the to the for broader to Medicine more the not This England who results analysis positive. example the for clarity kidney very Eckardt, among dialysis the grateful published Committee as tremendous as providers, as informative decisions make as when HIFs of was from physicians, about assays. quality quality believe well INNOXVATE class, these ongoing will of publications committee, work. consideration important both and patient of well in care, the of differentiating these and and in an program, only and they the independent key be X and differentiating reinforce patients, payers, with and We data treatment potentially rigor highly vadadustat and Chertow of to the all this a

publications. on with dialysis expanding believe in we a have growing first-to-market, and believe successful be clarity new vadadustat’s global due understanding that read we’re alone. large alfa market have the We We’ve in of progressing originally these of to Chief highly patients potential Importantly, as Medical to the papers that million clear today’s well X.X address treatment pre-launch to of And a CKD. safety by helping over upon driving course, publication and PDUFA will standard and we events, in will England non-dialysis data market. vadadustat similar vadadustat release, rapidly unmet the a $X and include the We thromboembolic will of questions now and to darbepoetin England broader compared anemia vadadustat supplementary the the very journal to I publications the us vadadustat than ahead about a represents in our and Journal Phase program. the links call also oral U.S. U.S. provided are on we our they and they believe you meaningful the adoption approval. dialysis establish on press on Officer, any billion the in to in U.S. we the of our these for have course, dialysis of regulatory website. anticipate positioned that Burke, we answer providers, potential consistency dialysis have launch on a to dialysis, are data the March, data the programs. as been to clear set dialysis and market in on Dr. commercialization to well subject as we’re More as path anticipated. events available provide We opportunity today critical With encourage recently, dialysis develop planning activities these focused More the no ensure protocols and care confident the bolstered exciting were journal potential seizures, approval, adverse for specifically, show the within to you that path in as to treatment very in of for Journal And needs role XXXX, our are opportunity for in events, which of recent adult showed New our are our seen signal infections. X publications, we’ve play including the for data New to significant data dialysis.

by can show We’re dosed also conducting two studies, one be to also partner that a Otsuka our three times week. vadadustat led

use positive, regimen, to are data this for post the the we Assuming this approval. data support NDA expect dosing to supplemental

majority growing the number cared of on enable providers, the COVID-XX administration, including access reports strategic are the dialysis important patients patients to that we largest are dialysis and treatment. CMS oral rapid in that home With to trends planned the progress. for vadadustat and dialysis pandemic to factors the supporting our home towards providers move the and for from center, their and of this once Although significant to grow to payment creating potential appears looking broad market. is vadadustat a the commercial patients encourage home proposition, Based to segment dialysis growing exciting we alignments, therapeutic can as several population. shift market launch adoption home dialysis. offer as in believe an to home simplify a support support we dialysis believe also dialysis convenient value be are These to these the models fastest better dialysis both daily has patients, growing of

now As product, a a focus. our go-to-market broad potential has strategy first-to-market

Care independent the of XX% dialysis U.S. distribution Our plans Medical include relationship and leveraging to patients. up our dialysis providers Pharma with to access include Vifor exclusive certain Fresenius which

important the the costs strategically to dialysis therapies the and Additionally, we that a plan in TDAPA with to market dialysis and force payment by this intended our of that’s Adding focused responsibilities. to Otsuka with account bundle to model is leverage our adoption for providers patients encourage U.S. nephrology innovative other of partner sales providers. DaVita and reimbursement in direct XX% adoption at launch clinicians facilitate remaining add-on dialysis sharing to the unique and

market process the Although suggests experience from TDAPA take it our may there’s regulatory the with of process, understanding months designation. limited TDAPA approval six to approximately

as two believe near-term strategy potential we TDAPA to rate continue originally market. anticipated. we be believe market of than dialysis product, long-term as the years support broader now Again, a has we Now, in payments timing our TDAPA go-to-market the will created opportunity will we vadadustat a And growth that both, for of important adoption. TDAPA potential first-in-class to this designation, designation in a and following believe

a dialysis FDA patient review with to for We efficacy we their compelling treatment oral cautious clear a both, put approval across prior remain data. the the non-dialysis. we CKD to package. have continuing while non-dialysis, the Consistent And for with and safe and look and and turning believe believe in we forward non-dialysis for the extensive to to data work is safety NDA anemia effective forward due in Now, of our need comments, we populations.

gears shifting our product, of commercial existing Now, Auryxia. performance to

second the in We’re encouraged with performance quarter. Auryxia’s

need. how the the Auryxia’s market great patients, to continues team continue getting be supporting our to therapies pleased to is our a and We importantly, job customers in strength. And those with viewing do

that to will hopeful industry the prioritizing vaccines to decline. mortality for continues COVID-related patients, and We’re on focus hospitalizations continue as dialysis

year. Auryxia annual expect deliver to expected again, outstanding team revenue for next the of And excited we’re to launch continue this with leverage XXXX. vadadustat growth We to

we’re like a of I’d Finally, on number that beyond. to with you focused for catalysts share XXXX and potential

XX, the of As March highest largest remains priority XXXX. our PDUFA action date with target market, potential with U.S. our vadadustat a

expect and to our We’re also vadadustat’s collaborate partner, this file year. continuing MAA Agency, the with to Medicines to European Otsuka, submissions later

share efforts from development more later explore look year. information We these to continue this vadadustat on potential and to opportunities

previously, severity of therapy syndrome discussed in to respiratory As ARDS, COVID-XX. and potential ongoing enrolled an prevent presentations results journals. including this of study. XXX-patient as X at currently due of we possible, engaged study and update They conferences share to medical future who’ve in UTHealth additional distress acute patients in on a XXX in adult at patients investigator sponsored expected vadadustat is or been lessen the an data, have peer when the over and towards and ASN We multiple look Phase we’ll abstracts our reviewed study, hospitalized and

potential progress pre-commercial move launch to on to our closer Lastly, vadadustat, share we the activities. as look of also we’ll

CKD. a at for engage with to to to remain as first-in-class Akebia. review over to we their summarize, look is to review our in who briefly potential a the in So, treatment now our time and exciting of NDA. due vadadustat’s Dave? financial turn I’ll confident Dave, And forward call results. FDA the anemia continuing We this busy will

David Spellman

John, everyone. you, morning, good Thank and

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

the to development quarter financial of completing Total in vadadustat. consistent our Turning million quarter for the reflecting to quarter, compared successfully results XXXX starting was second revenue. our clinical of $XX.X revenue global lower second $XX.X XXXX, collaboration million with of revenue X Phase with the for program

to the of the second million of In performance, X.X% terms product quarter $XX of net for Akebia’s second for million increased commercial quarter for compared with revenue XXXX Auryxia XXXX. $XX.X

which execution and environment. growth, great encouraged is team’s Auryxia’s of this product our profile believe in by illustration highlights ongoing nature critical favorable therapy. this are of this believe this also We a commercial COVID-XX We we performance the

strategies believe we drive ahead, our growth. will continue Looking marketing, the focus on payer and execution and team’s to product revenue sales net

Turning to expenses.

We execution and a of with quarter investments which of a costs, improving to PROXTECT, focus also to long-term vadadustat global consistent of the for consistent commitments, Cost completing pipeline the and XXXX quarter second the to charges other impairment million charge X $XX XXXX. in remains focused costs driven prioritize programs. million non-cash top development for in of $XX.X a our and the related that contract growth, were continue the excess $XXX.X of year sold both, second while for primarily revenue non-cash for spending quarter for goods of on and net reduction advancing was continuing our to line Research million of $XXX.X strategy, clinical economics of the support of second Auryxia by was noted compared opportunities. care on assets period. Current year million million Phase sold intangible includes second $XX.X purchase for quarter with product contract continued period and the Cost for press the XXXX XXXX. to of compared prior decrease $XX.X release impact included million in to development to goods expenses The INNOXVATE addition our charge growth.

well as build support of remain expected significant, the as planned work, our and clinical supply expect We ahead will of vadadustat. expenses as to the we inventory ongoing R&D chain continue that approval cost of

XXXX quarter of $XX.X the including respectively. others, Europe, to quarter are For million million second a second for of of The to costs and increased Selling, remind would expenses of was the prior that shared supply the collaboration general vadadustat with consistent agreements our we terms XXXX. for clarity, with compared regions expenses the year period administrative $XX.X potential to as to subject approval. partners, marketing Japan to vadadustat, U.S., and compared higher for due launch the we increase you to prepare for primarily like chain

As for Auryxia modest already the SG&A and only place, remainder a expect these XXXX our increase commercial for in we efforts team growth. is of in

due the $XX quarter the in year quarter loss for The was bottom of prior million the lower XXXX. non-recurrence lower compared second prior year XXXX to in quarter net the was line, by as as to improvement million to second $XXX.X partially the collaboration the primarily quarter revenue second period our charge of of well XXXX. operating net impairment offset onetime the for expenses, For loss for compared of

cash, with million We for and capital quarter our second available in position. equivalents Turning sale $XXX to ended securities. cash the

the from in Our in the impact million quarter. of ATM of QX our sales cash $XX.X proceeds second balance under stock net includes

$XX.X under the will subsequent quarter-end million through received be sales our believe least from ATM operating through cash net the that months. also plan our July at in We sufficient XX fund to next to XXth. current proceeds We the resources

period, of would of vadadustat and of subject our we believe runway from regulatory approval cash Akebia, has to Additionally, payments I’ll Otsuka, collaboration to the our in assuming and the that approval that the you remind respect the to future right terms extend agreements vadadustat with associated beyond milestone U.S. Europe. With milestones. to receipt of milestone payments upon timely Otsuka receive Akebia regulatory

$XX if Given non-dialysis are the million indications, succeeds in first milestones the U.S. million HIF-PHI from the respectively. and $XX regulatory nature being vadadustat U.S., dialysis to of milestones, the market in estimated tiered for these to Otsuka and be

sales milestones. Additionally, and there significant are commercial

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

inclusion approval U.S. of With with is license with the the million line Payment receive In to its has Akebia milestone consistent right TDAPA, the open Operator? questions. we’ll Prospective to whichever terms System, $XX of the first. or that, vadadustat agreement upon Vifor, in addition, our and payment a

Operator

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

Ally Bratzel

Ally Chris It’s on Bratzel for morning. this

from So, of the on us couple AdCom. just on vadadustat of based roxadustat a questions kind

confirm how outcome likelihood for could on-study to but an just convene on-treatment on shown the vadadustat that of the I during debate was vadadustat that a just, panel analyses could talk thinking an guess, population of the an that were basis? the first, the for you just MACE So in used [indiscernible] was the Second, on vadadustat? than articles, area your our the it you FDA roxa basis panel, rather will plan on AdCom. roxa analysis, MACE

wanted dosing. just then, to And on I last verify. question, So,

in INNOXVATE slower saw for So, PROXTECT. and hemoglobin for you rise a vadadustat assays in and

does three the schemes dosing discussion the on that validate hoping rapid So, AdCom, just that FDA of you to dosing competence the seem could the to on just vadadustat? the of will you’re talk the that at weekly to But dosing regulators. Anything you that hemoglobin? right roxadustat’s your be view acceptable the Thanks. increase regimens to profitability in FDA Xs. by in kind Steve, to does how times protocol the -- your related with exploring that identified Phase Maybe and or your

John Butler

questions. was a morning, list. long Ally. a the Good for of kind Thanks That

down. hopefully, we can jotted to them And I get So all them all.

So, to we’re all. happy them answer

for your communication is we had even we’re we’ve they then, the preparing FDA, vadadustat -- previously of at panel, was as the we that not likely now. one the whether first don’t panel we’re for we last and it’s question more as think the around a So, likely for less said But, panel of likelihood said panel. one. worth expect point. said the before to about I this or back Again, it’s the planning speculating roxadustat

any they from heard the would ready be learn we’ll we for like But, if that FDA on to panel, So, update that. that. haven’t we hold

an population ask analysis. question going on for And on-study second Steve? Burke to Your I’m that. the around analysis, this or Dr. comment was the to on-treatment was

Dr. Steven Burke

Yes.

to Journal intent As outlined publications, England New in of it treat in safety the analysis Medicine the was an population.

received back the So, study closure of end bring date, of patients study randomized to of the the very and medication, patients global study visit. end asked if at which we in a announced the completion followed further the the a time and we the of patient until was and study treatment those sites dose

to it’s intent So, treat. pure a

John Butler

that’s design had And a it to way and the consultation again, was regulators. true with I were where the study you patients. think because studies, the one strengths an you of continue that But, able active of we the control, follow to did the in

the that. question and third I gradual revolved again, for dose. I’ll And, it pass to think, dosing regimen your the around Steve

Dr. Steven Burke

regimen The is to Right. Journal dosing the in in including the starting while have hemoglobin. the increase in FDA, of designed designed was minimizing described England and gradual a dose. And hemoglobin hemoglobin the New with rise collaboration rapid was overshoots, sustained this in paper. Medicine It

John Butler

this And have before. been, I we’ve for I think, said again, the now, but we saying years did discussion -- FDA mean, with we’ve this

We, the studies Phase rapid If speak see again in both X think, you rise for right? starting results on and you in and rise, recall, consultation, the went day with to concern our overshoots. XXX dialysis a was XXX-milligram consultation really you agency importantly, too I And see -- in dose gradual milligrams hemoglobin. starting in that that non-dialysis. the If fewer a focused for and about dose themselves,

get perspective, efficacy is and that this a overshoots this that’s concerned so in quite more for. looking data why heard in is to long-term, data program good non-dialysis from think something the is that we over range have we time, clear. The overshoots, hemoglobin Doing dialysis we much the keeping confidence and program And both elevated in the about feel importantly, and aren’t them is the Physicians higher. they’re about. that those rush in the avoiding again, I very data. maybe And that what generated. really design how we avoiding FDA So, the

And and ongoing enrolling TIW. enrolled is focus -- -- that our fully around our third TIW modified is focus modify studies your So, question revolved now.

that’s have works. again, that dose able and And -- we ongoing add do saw when that importantly, approval. that effective to that. give data in in But to we the that’s clear see of you are small I an we’ll that Phase We Phase we the regulatory the is there want launching be daily those with, think, TIW? to know X, answer a dose know I we’ll anything viability most on -- you have We that don’t And dialysis. once were data, assuming Again, times that dose. so studies. we X obviously, Steve safe three as weekly is

Dr. Steven Burke

No.

John Butler

we Did your questions, cover Okay. all Ally?

Ally Bratzel

Thank you. Yes.

John Butler

Thank you.

Operator

Thank you.

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

Bert Hazlett

dialysis with TDAPA -- Just you home a on with longer more kind little and regard infrastructure, process? items so with to could a the what the then of talk maybe the And more dialysis about home near-term the of put gating little sales your Kind are? post-approval? then, and regard term more much. you secondly, could to meat bone efforts the that you’re considering with TDAPA, also Thanks commercial bit force

John Butler

questions. Great. the thanks for Bert,

TDAPA they’re dialysis. home on but to related, both but home So, and start Dell maybe dialysis are to ask, -- issues, the same? to so to of And not dialysis course, exactly going they’re I’m turn

Dell Faulkingham

as think like the Yes, in is feel for review home absolutely. our the under dialysis. you of We data strength, FDA. question. a Thanks about we’re position real with Clearly,

right growing that upon It’s market. population is the about fastest well-positioned really a this really the overshoots look adoption final look talked and a does X hemoglobin rise, there, at exactly dialysis the So, approval is well vadadustat just when you the clarity things segment is of year to about XX% the we is steady And data, that that drive about of going what not then And at rapid gradual dosing, sure to align thinking we’re about feel population. I think now. think growing like very our Phase the But, through when label to the it organizations. with the you relative dialysis home our John like.

to think, second your speak I to question…

John Butler

clearest I I mean, just largest it center the that out, I the out at still exactly mean, But, patients the today, are home. center are you a setting. studies ETC growing that right. CMS in think, about they on payment a why on home rate choice said is patients providers small XX% look population. coming home. to we’ve Treatment to example encourages of COVID is as the XX%. putting programs, patients program dialysis this and mandatory pandemic in population, of population, And that is matters. all to all to is different And people The getting something Choice, to is in was which more giving a program, focused wanted talked I mortality of these move encouraging, Having challenge. the -- emphasize ESRD all even which Dell is initiatives center said dialysis the the before, the

this one’s segment. fast-growing we is just vadadustat But going applicability be a both, a for To us. to sure, to so, And and think continue in clear is will is opportunity home be center. daily has dose. in used such and for really be home TDAPA another important opportunity

have a have the gone people not process. gone through through -- is none TDAPA lot it, this mean, I of So,

we understand we that, talk to Dell, think but that? want more do go. learn we So, you we’ll as But about

Dell Faulkingham

sure. Yes,

to point time, years, as understanding product. it we that’ll the the as will understanding those people, reputation six have think strong quickly. after help about Right coverage think approval. XXX when be will the our be really I the nephrology really And at the force. we approved. team like look patient adoption, now, well, launch launch in vadadustat rule we -- clear. receive And and community. system patients And our at seems we that time supporting really us we is is you set be we we’ll And with be rule soon the we this is, the leverage strong for on be our at really between. very is promotion launch right is months apply that quarterly once employees, two our up Auryxia will about in TDAPA essentially, when The the be And and a think, of And that eligible have based dialysis DO to hyperphosphatemia, for have they today. launch field infrastructure are with based experienced the vadadustat quickly. as coverage. nephrologists Auryxia commercial Our commercial period -- possible, that to believe launch And a with looking could is ramp where key majority a TDAPA feel reimbursement. revenue before is we And commercial and sales of in in and so with there’ll some We overlap coding

John Butler

only this how for to thing again, Now, exactly that, of the comes we’re thanks the only kind is emphasize the down. going TDAPA, on I’ll -- Dell, see

after when through approval can. process to point, right TDAPA launch in will Remember, need after the very start really go to providers have the to access approval, important that as We working protocols. it’s of we’ll quickly those quickly patients. to for They as can. protocols at And the as their as we on those dialysis all convert have drug they we order

well. So, the quite timing works actually

think, wanted I as that just really the Dell reimbursement. of TDAPA speed said, that we will the to influence emphasize it because having ramp, process,

that’s make Bert? were to that -- that. help, So, I just clear Does wanted sure about really we

Bert Hazlett

Yes, that does.

With quick of those could, if CMC, and NDA, Just just the items are gating issues with the a quick to of one? actually just follow-up regard manufacturing to I progress shift. a any regard

John Butler

plan part gating of we’ll our all No was our for was in drug as drug have NDA. of we’re confident substance And Obviously, that our manufacturers items multiple products, us. that NDA. and included

So, we that. fine feel about

Operator

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

Unidentified Analyst

dialysis for already in is and [ph] dialysis dynamics place? also, We some you U.S. for Europe. Alethia. you my taking Thanks. investment progress. congrats in share force sales market in much the on broadly the Nina could differences Japan, for more in is Hi. and could the were approved And XXXX, share launch, you on Thanks needed wondering how just for questions. And if non-dialysis if have if since the This

John Butler

question. the for you Thank

kind handle a So, of I’ll the sense. market general dynamics in

dialysis ESA. of The with because So, the market the -- talked quite ESA U.S. it’s is We’ve markets whereas generally the concerns, routinely the product, the injectable, with and treated from an of difficulty patients are that perspective. about lot the are fact reimbursement perspective, a treated non-dialysis different treatment dialysis not the a patients non-dialysis are acquiring that. safety

few market U.S. the of market I in market the market dialysis smaller a size small bit different. it’s the in UK are about has every because is Europe Europe, the hundreds mean, where large, opportunity. non-dialysis country it’s where So, take very a U.S., quite And we to as it’s talk very we centers, think dialysis dialysis we there’s hard market. The vis-à-vis Germany, of Europe, growing centers. very where is little share, about in and dialysis

are ESAs The in is the patients with frequently other Europe. that difference treated more non-dialysis

the access the been concern healthy of the the good. of these more not There no also healthy, It’s European safety available so Japan. level kind European products population patients, acceptable been the in because as culturally is never market. patients, high market biosimilar has and treated, So, around in -- are more is they’re transplant. in for non-dialysis has Japan dialysis there’s

So, healthy and patients, as they outcomes, dialysis, go so on longer. their are usual, good quite

similarly, at market the you’re Dell, in there? growing I anything non-dialysis I miss think looking Japan. did

Dell Faulkingham

all. it No, you’ve I think covered

Unidentified Analyst

the in investment last question U.S.? was the the think I

John Butler

do Dell, want you to?

Dell Faulkingham

Absolutely.

that opportunity think like at we’ll with where and we And create to very our experience of be a the launch. when overall, whole is But, maximizes to of the we lot add we closely portfolio, going We coming strength from today. ahead. like about them support investment right really feel and vadadustat deployment sales -- more. really really a we’re about together it need like is we lies what it to the organization. need to the bag, our incremental work here think collaborate We position position As we’re with And in from launch Otsuka, to that going infrastructure, we’ll to you existing feel vadadustat. feel with so said, vadadustat the strength we commercial the speak have excited really have we’re to we and in

Operator

Thank you.

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

Unidentified Analyst

questions This [ph] Dave, for us. morning. from is Avatar this on Jones Few

so inhibition. of in also regard? FDA aside have then, on received hemoglobin the rapid on Can that vadadustat you and plan progress non-specific events -- rise, lastly, you And you. MACE on Thank that Auryxia’s causality prophesized do coverage? from can have MACE questions of First, any to related roxa’s to they those? litigation be Secondly, events? so, could you how panel, from HIF And the comment updates address the if you

John Butler

comments. the for you Thank Great.

in are with we discussions So, FDA. the

broadly. because Now, the they nature them, look won’t kind of to the it’s normal speak review of process,

So, have data. they’re robust And in package. very, again, we confidence very the

FDA in questions feel of And that any we confident so, answer the to being able raises.

So, commenting on they up non-specific a that there panel, or HIF effects. brought be the fact this idea may target that

it’s look to I at really important data. think, the

differences does the of the product. And know if tell the we we’ve are vadadustat. profile where FDA think the dosing with don’t land that we is, what think I was driven I have the very of will that or safety I us? because data regimen confident in in what because data always generated kind right that’s

of the the have efficacy the and the vadadustat, today, We on what that managing before EPO increasing any that’s recognized of preference we here safety of vadadustat and the matters. most us characteristics based room we’ve HIF are for believe always and and the And the of for company, in we’re as that we support who to the selected complexity with give data were anemia. product it development to going kind pathway

quite question updates So, around we product the will litigation, of we further we’re that as the in And generated. was because we that, data ongoing. then, we’re confident really that Auryxia you. as the have confident third product. and quite update the And is soon any in And beyond

Operator

Securities. line Our next Difei of question with Mizuho the comes Yang from

Unidentified Analyst

Dan for Clark This you. on is thank Hi, Difei. [ph]

question competitor? versus community feedback ESAs us, HIFs? oral other be from your versus We’d regarding and the the nephrologists data you’ve of the changed heard curious on data know has to First from anything outcome

John Butler

difference The think in we obviously, here lead we the long very is remember, Medicine don’t that I table our papers about maybe huge it’s talk it and those is that to And the vadadustat New Steering co-chairs conversations for we early the again, of credibility were the that And to INNOXVATE makes don’t are -- on by the nephrologists. and full. have a we England go of this Journal with publication. review the and process of communication. in of Committee the brings think each encouraged can Independent I data Journal PROXTECT. the England a of enough. mean, Executive I talk difference nephrologists But, authors about that directly New it

abstract the So, done us process, the at the as beginning show have overseen significant New you the to end analysis don’t that, I the committee, allows very add up -- general credibility and data, collaboration the Steve steering differentiation. in I that the want meetings, of we Journal, how this and and in great to analyses if of brings Dell the with independent the scientific think, at England do the in from been day to or know data Dell, some?

Dell Faulkingham

Yes.

create as I still in forward lot first-in-class some and and as nephrologists people differentiating need, moving as hear the ensuring from And we do, that the think, ESAs ensuring certainly confusion a unmet events to very on and believe are product substantial that marketplace. certainly HIFs other is work are and nephrologists. vadadustat really I market clear well. we recent which perceptions have potential of that we here, the well from understand as that But we think

John Butler

dialysis was FDA thing important that think, here most from of the came And that open both where heard hour heard the and out patients AdCom the I need the well also. the I been non-dialysis need. have patients sees you as discussion of know that might That about and

by position. encouraged our we’re So,

Unidentified Analyst

us. Just another quick from one

that the plan commercialization materially out following opportunity mentioned there your a commercialization changes meeting? AdCom, plans to as that you you your AdCom following larger As have I made change, now understand

John Butler

the yes, same. have So, about opportunity the is I excited mean, in mean, still opportunity his still for I us. just market pretty I the and are team We guess fairness, the same, Dell that.

Dell Faulkingham

Yes.

We’re really excited about it.

a to ourselves and the products, the marketplace to talked and well marketplace, to in from be really opportunity build first the HIF gives as the I that as need mentioned, about. as ESA, opportunity, the differentiate other us to in the John help really leader think, be as unmet

first to as we and the certainly vadadustat at market changed in the how potentially, we in when customers think But plan, we’re upon really commercialization how really, it. that engage engaging we’re look working market So, the don’t plan lead, marketplace, our with about opportunity today with with I to approval. the you overall be Auryxia materially product to and recognize excited it’s

John Butler

in relationship us has lot a power still with And for of also. Vifor

for As we what us the needle that really the that’s dialysis in moves said quickly community.

game is. really time, us. an is first So, for potentially to to yes, a exciting it’s opportunity of market changer The it be kind

Operator

you. Thank

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

open. is line Your

Eric Joseph

the the what applies for and then, pricing the constraints in you And net dialysis non-dialysis two how non-dialysis between and both mean segments? economic TDAPA eligibility with separately, bit Assuming can the is the two that And just a vadadustat approval little unpack in something more in perhaps settings, differ segments? that reimbursement setting? could Thanks.

John Butler

very different two are standpoint. walk a through to from And I’ll reimbursement and They markets different ask that. Dell

Dell Faulkingham

be believe it’s the we that highest I are rule which part for the and patients opportunity, really intended organization dialysis the we’re PPS is that And So, the will contract-driven of launch. think to TDAPA look drive innovative here, the the at and clear covered products And use starting you at dialysis of with new the when it’s bundle. -- we payment, level. at at eligible level, think for,

other largely there are payment but dialysis the that, drives through still to addition In that contract. groups,

that’s if at you look dialysis business. So, the

that the coverage that’s focus space, obviously, forward. will NDD access And moving If for and key it’s us coverage you now. a will be and move And to contracting PBMs able drive typical and be obtain the for we and more the population, we given unmet for important going over product to the get and with be of right anticipate, the reimbursement. That in look need product. coverage at payers our

John Butler

the as data but NDD areas. that And given also I to ready the you make as launch again, second sure, said said, in submitted. cautious question… on we’ll I to the But tell And [indiscernible] we in upfront, we’ve confident we we that quite want a had both still Yes. indication, -- And remain overall we people be always feel base.

Eric Joseph

TDAPA eligibility.

John Butler

Yes. TDAPA the non-dialysis to was eligibility applied not setting.

Operator

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

Ed Arce

Three me. for

or were that I’m adverse any differentiation there, events on line focus highlighted the And talked if that that around ASM data, around could we the potential look we or at look for here, the is in recent quantitative either at you rise First, analysis? to, EPO perhaps about there’s or something wondering -- any New if of to Journal, overshoots. That’s discussion England data one. can there’s as rapid specifically point publication that follow-on you the on the to the AdCom. given the could

tenapanor know overall on milestones. your CRO of finally, impact some receipt growth on prepared just going this on on the then, missed forward? remarks, of question in the there the in space the given we wondering impact clinicians but over and went I regulatory numbers. is Auryxia’s from hyperphosphatemia, And the I the Second impressions the potentially to the

So, repeat if be helpful. much. could you that. you That’d Thank so

John Butler

questions. much Ed, thanks for so your

it publication said haven’t on which could And that first, to data we be be later. we was differentiator. fewer a what we darbepoetin. an the AEs, the certainly do overshoots published So basis clearly vadadustat think for is is the it That important EPO, on versus will

So were I think that you bring right up. to

Kristen Sheppard

And in that publication. New the is England Journal, mentioned all

John Butler

It is, yes.

at doesn’t it’s data point. accompany Sorry just mentioned. The this Kristen,

second publication own. CRO then, that. your was interesting and impact tenapanor its on the on And on for the question would certainly but So, be an

manage company As focused phosphorus lower a level, hyperphosphatemia, be anything welcome. actually can that think lower care, would patient help purpose-driven patients hyper on that’s I a achieve --

will products but do add to we it comments see year. believe we from se, really you be that -- potential this competitor think as never together, thought that, I the -- we want but looked Other a of there don’t in guess, a on that? in that perspective, it Auryxia’s disappointing. be and per We utilization would that impact. really growth Dell, it’s So, than I at much grow would

Dell Faulkingham

that has in equation an a of important of hyperphosphatemia believe part we there that. a an from efficacy improvement patient data world that that And John think lot impact is is outcomes, perspective treatment improving certainly, more space. and safety But, it for in so, years. And for real for it’s outcomes. have a I been No, six and supports than said, amount foundational room we Auryxia the and in of tremendous as

to drive So, with revenue execute against we our hope from plans our accomplish point-of-view, it forward. net to we’re hasn’t commercial really moving changed growth what going Auryxia. And our to of to view continue

John Butler

David… Thanks, Dell. And

David Spellman

milestones. Ed, the can regulatory clarify Yes. I

So, and million. a be the be first the first HIF we million; if $XX U.S., approved dialysis, for are HIF in milestone would non-dialysis, $XX would in approved the that in

Operator

and to back Ladies Mr. Q&A that the for Butler over like I closing call gentlemen, our turn concludes session. would to now remarks.

John Butler

Thanks, to Towanda. for today. And the thanks call joined everyone us who

The Akebia. the to mentioned, we to a as look is forward And we’ll move exciting update to continuing for Company. year. class I potential this Thank really energizing first through you. As time very be you is in on the our progress

Operator

Ladies and gentlemen, Thank this for concludes you conference call. your today’s participation.

disconnect. now may You

Akebia Therapeutics (AKBA) 5 Aug 212021 Q2 Earnings call transcript