AKBA - Earnings call transcript Q1 2020 | Akebia Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Akebia Therapeutics' INNO2VATE Top-line Data Readout Call and its First Quarter Financial Results and Business Highlights Conference Call.

As a reminder, this call is being recorded.

I would now like to introduce your host for today's conference, Kristen Sheppard.

Kristen Sheppard

Thank you, and good morning. My name is Kristen Sheppard, Senior Vice President of Investor Relations at Akebia. treatment for our to of adult global candidate, for much data Akebia's our dialysis-dependent so to vadadustat, INNOXVATE, due for Phase the patients. you joining disease discuss us Top-line product chronic Thank kidney anemia in of X program

results results two top-line On call today's financial press Relations call. these highlights. containing morning; containing the INNOXVATE's financial with releases followed business also recent by business our slides first quarter site discuss Web are this other today's our Akebia's highlights. data, Both one press will for along exciting Investor XXXX available we recent and and We issued one our on of releases

also conclude be after on site convenience, shortly webcast. Web today's available your audio today's an call, will For our we of replay with slides, the

Joining Officer. John our Chief Amello, Dr. Steven President and Chief Executive Chief Officer; and Jason call Medical Officer; are Burke, Financial Butler, today

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

forward-looking to of this this these speak call on only update The statements. these Analysis and with any the Factors the described is any Management's Discussion statements we call and and in recent and SEC, the on and Additional of the in annual note original regarding do of or slides. sections information forward-looking date most statements factors not our filed of Risk quarterly in reports cautionary as undertake revise obligation the

John? to like our I'd to call that, turn CEO, John over Butler. With the

John Butler

everyone. welcome Thank you, and to Kristen,

investigational this yield data the disease. anemia be to compelling hypoxia-inducible to chronic two see announce oral extremely treat HIF-PHI, It positive of clear, from our results. the factor program programs X are thrilled and our able studying hydroxylase prolyl positive is or to vadadustat, rewarding We inhibitor, INNOXVATE, to global Phase of first consistent, top-line kidney

accomplished participating, day This thank participated I but Akebia is important the most X,XXX for a nearly risk who alone. program. team in very our the among not want COVID-XX. sincerely their Dialysis this for but I patients thank and investigators staff patients and most importantly, at it by to want hit the was are hardest Akebia, by to

Vifor I'd shareholders these uncertain work our of critical our and efforts Otsuka, the for advance reminded our significant to partner, dialysis, thank to we're both Akebia need patients. and of our and far. supporting During also times, collaboration the Pharma, care for nature our like in partner these thus

despite closing our employees. to of one today of collective by to better us impacted thanks to we here We efforts operating Akebia conclusion. sincere bring kidney you. the lives environment, brining without step and did of I'm our proud logistical The under analyzing INNOXVATE collaborating timely of job the and team an the each present data the Again, my believe closer of extremely disease. studies, be a all purpose extraordinary all fulfilling wouldn’t successful COVID the to challenges everyone, our person

response this pathway going with exciting positive mitigate our to In we are provide terms impacts. COVID-XX start will announced discussion morning, our on of call, the issued and looking of that top-line March we've for developed updates. rest that potential I'll focused impacting today's XX, and data today The the We how be we working and vadadustat. some on an we're our is agenda how COVID business for to initial at to

might any review the questions is QX of of for We data will have a in lot but available to cover, time have. Jason you and interest exciting so, the results, not

the always, open Q&A. for As we'll call following discussions, our

and relevant ever. person impacted purpose challenging this each our better the to In is kidney more lives than of important environment disease by

is innovative are and support to as protecting risk. at and critical non-dialysis end, well who all among doing Continuing safety the therapies most can CKD patients, priority, therapies our the as customers, limit to health the provide dialysis of virus, Our a to critical and are disease is as employees. and of we're community. spread and we To support patients, patients that the our kidney our

Our been incredibly work-from-home policy. team has productive our under

support volunteering medical and patients, has kidney continuity, and at While ensuring response donating meals our clinics care workers donating treating Kidney supplies the patients. the pandemic Coronavirus to support to business Boston, to Emergency efforts Fund national frontline of team needs by Fund to to continued provide local COVID-XX the healthcare COVID to American and in

date, financial have remained terms fundamentals COVID-XX, our any strong. In from our experienced not adverse of we and to and operational significant have impact performance,

As to our said, runway cash well clear weeks and that of QX, into we of XXXX. months. the for upcoming on what expect via extends unprecedented times, are have these and end visibility With the COVID-XX no

therapy, from the we're risks mindful and macro on We and of impact demand system marketed healthcare potential monitoring on the our mix. the also potential are closely the impact for payer

actively Given situation. measures take monitor to and this we evolving uncertainty, this precautionary continue

Our as and as on important our clinical ever. focus programs ongoing is studies

for a for advanced significantly, and expect and by new as vadadustat data is year-end, enrolling COVID precautions vadadustat in have we year, delay clinical mid studies planned. continue Also, causing Forward planned. however top-line our data PROXTECT top-line trials. fully are X to Our expect as trials enrolled,

ongoing remote For remote we're trials, possible. patient monitoring visits using performing where and

our responding during healthcare tools including here we technology We needs. AkebiaCares. and our continuity enable interact Our important providers, are can care virtually customer-facing an crisis, leveraging important play Akebia programs and and like help are believe in to commercial of centers, to teams this and with dialysis and to patients their with supporting customers role

we business. before our These our Auryxia across sourced the our pandemic, time, supply At business this patients our our COVID the inventory for ability is goal them new believe to not the fortunate of currently to supply should already look had we single rely have plans that disruption, help measures are vadadustat. functioning, don’t on or to materials and that with while ensure one operating provide chain operating, are manufacturers even implementing critical are chain supply impact We begun that we mitigate driving therapies across anticipate from who continuity our occur. either supplier and any to a efficiencies safeguarding we

In uncertain sum, this new COVID presented environment our to business. has risks

than our control. data. we purpose, a that’s the opportunities our to impact our on is more we is have ahead, outside value segue many to that bright any INNOXVATE that tremendous mitigate and to team market enhancing ever committed risks and working are we we larger While believe deliver are hard mindful and the great potential are of our impact, spot to these The healthcare

we and today. and are compelling the clear, Again, succeeded data MACE very we key confirming once-daily announced alfa. the the can consistent, X Aranesp with the and efficacy in primary secondary or this hemoglobin of increase maintain INNOXVATE two excited meeting range therapy studies, target the endpoint similar in that to darbepoetin Vadadustat case, particularly oral in efficacy that vadadustat of phase in with current and standard each safety, care,

vadadustat all-cause nonfatal many anemia Major consistent first infarction, in primary MACE, defined for vadadustat is increased clear adult patient, to or the the due to in with the standard has dialysis safety as remarkably been dialysis safety years, Confirming stroke. non-inferiority time and results achieved cardiovascular patient prevalent also patient. all myocardial of in with compared to composite INNOXVATE patient or Cardiovascular which of or with CKD. no patients Adverse of Events and of of on anemia the dialysis, endpoint occurrence These risk program, nonfatal of demonstrated CKD, were was mortality, incident new across due to whether care populations an Vadadustat a

agreed regulators. non-inferiority these Importantly, plan, were with of statistical analyses analysis to on all a based and margins

with approximately ESAs in a dialysis manage The their Erythropoiesis XX% with significant profound. patients general, this have the of CKD dialysis patients are disease health XXX,XXX been issues. there patients Stimulating Agents or Today, this on anemia. In is of population to impact with Approximately, U.S. is treated

been complications, In ventricular such congestive including anemia dizziness, with symptoms Multiple fatigue, failure. patients. in speed demonstrated the and hemoglobin more the and of with left the risk of hemoglobin have cardiovascular with non-dialysis well-known risk of severe that associated hypertrophy ESA, and of peer-reviewed addition associate breath, increased shortness above outcomes studies the levels cardiovascular as of large excretions doses to adverse and by has heart the ESAs increase, associated achieved Physicians EPO both XX dialysis g/dl.

treatment and patients goal CKD, was new a INNOXVATE designed oral demonstrated levels, in data for Vadadustat the including as standard believe patients further has oral and our data for with treating subject increasing has support what hemoglobin vadadustat populations what of incident to development in program all want with research nephrologists due a physiologic patients. dialysis potential manner, their convenient hemoglobin predictable approval. minimizing treatment EPO to excretions, maintaining of option prevalent consistently uniquely suggest a and We care anemia of new dialysis providing both positioned vadadustat dose. a

of headline that The X and evaluate INNOXVATE injectable an clinical, darbepoetin, with long vadadustat belief. success. commercial And standard of INNOXVATE treatment to is control anemia efficacy program believe active support continues to global two results using of cardiovascular the be non-inferiority consists ESA, care. our the is an regulatory, studies which we to designed that and current the phase for designed for it during safety continue

the put, and and order of this the that to we FDA we our compare Simply order standard in program constructed change design dialogue after you thoughtfully the Simply believe extensive standard We of in of care. care, regulators. that standard put, change to need the European trial to with to believe care.

agreed the the plan. components and statistical plan our prospectively have on we We of the key defined EMA, and to analysis and with with agreed also straightforward statistical non-inferiority a analysis margins FDA FDA

a enabled share and clear Our yielded and and dialysis data payers. both straightforward design a to program, wait INNOXVATE ultimately We compelling on with analysis can't and trial readout our regulators, providers, MACE data efficacy and collection safety. physicians, across and with has these of

that regulatory ever, are supports confident vadadustat clinical than with front. the on We success INNOXVATE for success we've the potential more demonstrated

payers also data important vadadustat INNOXVATE patient care decisions providers, highly will once informative be for about We they confident make approved. the are dialysis is that patients, physicians, and as

I specifics. all know we're the get into to excited

the Chief let Dr. Burke. hand me our call So, over Steve? Medical Steven to Officer,

Steven Burke

data and team very R&D John, Akebia, behalf excited On morning of everyone. the good you, these at Thank to share today. we're

condition our impact progression. serious associated to is has As quality costs CKD characterized of a The healthcare cardiovascular adds mortality, as is by John risk of CKD due burden a and system. and to and significant as increased with significant patient anemia hemoglobin events, well on decreased hospitalization, of mentioned, CKD life,

is Anemia along blood supplementation with iron red transfusions. with cell currently ESAs, or treated injectable

Considering of effective risk hemoglobin cardiovascular evidence mortality. In particular, particularly doses are administered need treatment, for the believe an use. INNOXVATE potential their our associated are adverse advance ESAs ESAs effective experienced we for was there levels, NDA higher raising there While stroke patients of data with increased events, in risks safe safety well-documented that vadadustat. and and also and unmet the approval an plans compelling medical are of

Prize absorption, natural physiologic iron Nobel HIF-PHI HIF, science, and a of delivery transcription endogenous bone winning once-daily, orally-administered response in erythropoietin iron on up-regulates to By in low leads increase in utilization. transport, to hemoglobin. proteins was The to body's Based vadadustat production red oxygen. in designed marrow stabilizing to blood investigational involved higher cell the the of increased in erythropoietin or vadadustat mimic as hypoxia

X,XXX due program dialysis-dependent in a efficacy anemia conversion, cardiovascular vadadustat darbepoetin safety, Phase injectable INNOXVATE large, and for to correction, care, The X and and alfa enrolled studies: well compare a This current program included and is very ESA. of rigorous, to thoughtfully-designed CKD. which conversion, to patients to with was collectively standard powered

studies, INNOXVATE non-inferiority on illustrated sponsor-blind agreed evaluation FDA change multi-center was protocols, XX XX versus were reviewed the slide both open endpoint As safety studies label, between in in and difference primary which weeks. In by primary measured X, period, in the upon aligned non-inferiority but darbepoetin, right of global efficacy hemoglobin of the EMA. efficacy baseline and were the was with studies. margin and mean the on summarized endpoints vadadustat as side and between both non-inferiority INNOXVATE slide and The

primary and stroke. agreed efficacy defined cause by non-fatal and the was the were program's endpoint, independently versus for as MACE XX evaluation FDA Clinical also endpoint time non-fatal to a during vadadustat and Brigham Endpoints safety weeks with was infarction, and Women's studies. darbepoetin key mortality, INNOXVATE of non-inferiority XX. secondary was combined period events non-inferiority secondary between The blindly or EMA in first MACE myocardial all The Hospital MACE adjudicated the INNOXVATE Center. The

in either at was receive was one-to-one As down was week up in patients five, shown dose and of darbepoetin. both in increments starting initiated slide Vadadustat to of darbepoetin XXX milligrams of dosed or XXX other XXX studies, vadadustat label. were or once-daily adjusted and four dose, in those or randomized milligrams daily. to switched product milligrams to XXX their within the in Darbepoetin darbepoetin receiving intravenously and subcutaneously. prior the were range approved to already maintained according Patients administered ESAs

less protocol-specified Study hemoglobin blood XX supplementation as the XX criteria, guidelines. drugs X,XXX conversion were to patients dialysis XX target of who were in weeks incident prevalent were aligning cell study red dialysis receiving achieve XXX dialysis transfusions U.S. and clinical U.S. prior to Iron outside than in with allowed to medication the rescue XX to screening. Correction/Conversion for titrated to The practice XX evaluated study necessary patients, The on evaluated ESAs. according ESA

and which population. the patient's baseline summarizes representative groups six Slide of treatment are similar dialysis between general the characteristics

was percentage with of there patients disease high As cardiovascular expected, diabetes. a and

minus and vadadustat X.XX. margin secondary primary period lower maintained non-inferiority per to key the In above in at XX conversion for darbepoetin. of mean confidence mean secondary hemoglobin of hemoglobin of seven The was interval hemoglobin deciliter hemoglobin minus margin XX.XX of difference the efficacy XX patients, change above grams The non-inferior were for Slide XX response confidence at dialysis weeks. mean confidence bound non-inferiority hemoglobin X.XX. to evaluation minus pre-specified the the the minus Again to XX prevalent was endpoint X.XX. to of was weeks XX.XX X.XX difference vadadustat and in data. XX XX to interval XX.XX XX.X was X.XX XX% in mean X.XX. The summarizes was of with darbepoetin vadadustat of of darbepoetin. a with for the weeks minus minus for The and bound study interval The the lower the was pre-specified a

study the a pre-specified hemoglobin was bound minus margin dialysis lower patients, interval of mean at Correction/Conversion inferior with the the darbepoetin, minus vadadustat hemoglobin X.XX non incident the and In X.XX XX XX XX.XX were X.XX. crossing to was with confidence of X.XX minus for difference and evaluation hemoglobin darbepoetin to secondary The in mean minus mean difference was of and not with non-inferiority XX The maintained XX% The XX weeks. for in vadadustat was of responses to the darbepoetin. XX.XX to weeks a X.XX. XX.XX of hemoglobin XX.XX XX period weeks XX vadadustat of of for

confidence interval was Again, the of above the the non-inferiority lower margin bound X.XX. pre-specified of minus

with these saw very We’re pleased we what with which studies last efficacy ASN X Japanese results. They're very Phase presented year. consistent the at were in

with time Now interval moving X.X first on of agreed agreed upon based non-fatal darbepoetin. The upon was MACE X.XX from bound hazard with X.XX first the time and was vadadustat FDA ratio to non-inferiority for Analysis deaths, primary and confidence includes margin EMA. upper the of The a to to MACE model Safety, COX the endpoint interval MIs XX% slide was MACE. below X.XX. confidence eight of and hazard to summarizes X.XX safety to the was the strokes. non-fatal comparing ratio MACE the

the time to two groups. displays the curves the The group is blue red and event MACE nine line is vadadustat the Slide line Kaplan-Meier the first for group. darbepoetin in

of demonstrate to similar such between of patients vadadustat safety in pneumonia, today is the straightforward dialysis, to Slide either of to efficacy clear, or regulatory The treatment two treat the XX hypertension, emerging potential occurring on included both and These XX% approval. in in results patients events subject and adverse to INNOXVATE adult common It treatment summarizes group events common were groups treatment most great than events equal emerging greater in adverse events anemia CKD positive studies. studies. and diarrhea, to the hyperkalemia. obtain

with the will working as this PROXTECT following findings, as NDA, on pleased the to medical The data peer-reviewed later a and possible We’re the with conference, at present together file the results data readout. from publish data and we is already quickly our excited our team full the journals. from program which INNOXVATE in R&D year PROXTECT

back I over Thank will the now turn call you. John. to

John Butler

compelling, and for Steve. dataset We believe vadadustat. strong, straightforward very a have we Thanks,

next, forward make we transformational we uncertain, of although what's of We progress terms will In milestones. have the near-term an first the exciting for COVID-XX and vadadustat environment these believe remind that solid is potentially path and advancing continue Akebia, many you INNOXVATE developed I remains activities. to

be year. dependent market. non-dialysis in CKD In Tanabe, of first in collaboration in to to patients due treat with Upon is anemia our expected first Mitsubishi to a partner, key activities we're of Japan in that pre-commercial major vadadustat the both this be would dialysis advancing approval support and adult expected HIF-PHI vadadustat the regulatory approval available

As we We've evaluating study global top have in of planned. Phase and achieved safety I advanced to PROXTECT, target MACE the CKD. due adult our line dependent non-dialysis events patients X vadadustat significantly anemia the of mentioned expect the mid-year with number data earlier, study efficacy as for and

In addition, intellectual upon we and rest to are and vadadustat positioned partner our execute property our Otsuka position launch on to of for Akebia the the approval. confirming collaboration both for vadadustat potentially reinforced plans Europe U.K., in

We to as X these adult as the other program, possible. quickly vadadustat wait agencies the plan hand, to as in and our dialysis submit we successful patients dependent for the approval and non-dialysis of completion soon can't U.S. with regulatory get FDA data for Phase in regulatory data of PROXTECT in filings as Upon of front both marketing and possible.

regions Otsuka collaboration in and with And all. not in other that's then

the or access for NDA Vifor agreement an expedite to with to Voucher with review. the potentially have vadadustat to Pharma We Priority PRV FDA Review

quickly of potential bringing regulatory there would be possible, vadadustat enhance believe done, to to more work we path to the as patients subject is as meaningfully While approval. this

amount tremendous these in data. confidence We of have a

activity. very working hard also we're on So pre-commercialization

HIF to vadadustat exclusive due dialysis the for the full potential top working extremely presentation about team their centers rapid new with of possible up Vifor be publication vadadustat’s upon and we're standard medical care approval, believe the and U.S. conference. have to We patients the potential as momentum distribute agreement to of to is certain dialysis these adoption upcoming upon vadadustat anemia to and So data. build believe again, the quickly The line and patients U.S. other excited prepare support dialysis support for of the as Fresenius up, data Wrapping clinics an in data in as in oral approval. we at CKD the has XX% to we

We to positioned are advancing better right person by disease. we the want where purpose to impacted continue well each be, to lives our kidney of

that, the I'll answer on financial With that to press open release. in your to pertaining the our answer to any up top questions. disclosed quarter first results. we'll is call note line also results questions based questions available Please the Jason

Operator, the ready we're first question. for

Operator

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

Your now line is open.

Allison Bratzel

on Chris. the Bratzel Ally on Congrats this Hi is for data.

just can does confidence And our point? year, expectations And swing how at generally later in to disclose endpoint data on So, file on and know actual first, how being main able this just maybe full an ability the pre-dialysis prepared your PROXTECT, and talk remarks, we NDA bit the is midyear, to this readout, should about reaching you confidence that you've INNOXVATE a pre-dialysis talked in COVID change the the adjust the PROXTECT? your I in just in but if timing about then, still

John Butler

Thanks Ally. Thanks, questions. the for

it's we're we as continuing mentioned, the timing situation, moment we us. when be monitor as data, move obviously and PROXTECT XXXX, very to be quickly mid filing, but I as of I for the confident deliver obviously then possible and XXXX, the a to today, we'll able to incredibly an on time COVID as will get mid PROXTECT exciting is mean but in on data feel that dependant So we'll that for

important at to cetera. same how control, we're is And At design a PROXTECT second time, influence, we question the the around it's INNOXVATE that about identical, active now it's your looking with et data feel how PROXTECT, I different basically program. does the same think collection, the same look, that

couldn’t and can't path be soon, forward. this see we it, more about to we have very, very see wait excited data we'll and So, the we going

Allison Bratzel

any FDA to EMA. maybe to I past or can question And you X.XX, indicated for X.X agreement in on how FDA asked maybe X.XX non-inferiority Great. agreed non-inferiority think the why margin then [Ph] for a pre-dialysis maybe there's [renal another then you about -- only look think would of PROXTECT different for for the margin, they number with to if came Could the for prospectively on so that margin reason non-inferiority agreed when X.X, drug] you for you'd the MACE and you FDA program. the differ, talk to address if agencies but and

John Butler

most when it upper comfortable and So, both extensive authority. dialogue importantly, within X.XX an agencies, regulatory of data, comfortably at with for look landed regulatory with with bound both, the was we we're the we're either you non-inferiority very where with range and

we're from So to today, same very, shown the you very pleased what show we've hoping we're again, PROXTECT. and with

Allison Bratzel

for Great. about current a vadadustat? for [Ph] And last expectations could [AdCom] then, your for maybe just potential you me, question talk

John Butler

is that's AdCom FDA. the an -- to Well, up

So We'll of both in we of can't we to of we'll put in to see. and wait regulators. as quickly front the sets data wait put and front them this can, data as have

be ready want very AdCom, So we'll have if for it. to an they

Allison Bratzel

congrats so and again. much, great. Thanks Okay,

John Butler

Ally. Thanks,

Operator

Thank you.

next JPMorgan. Our question Eric comes with from Joseph

now is open. line Your

Eric Joseph

and on deliberately questions, on studies against up chose you for here, and [Ph] sort you were INNOXVATE [clinic of dialysis to X design roxadustat? guys, relative risk to ability Hey designed, Phase Epogen, [indiscernible] these in against benefit to thanks pick about taking compare Can congrats view comments our comparisons I studies care. darbepoetin of John, sort your might crosstalk to darbepoetin that versus alfa, the how to make to versus aid or any readout the just wanted and the meaningful go with here. the alfa speak of whether standard how nephrologists -- studies] and there's the of the distinction from

John Butler

I didn’t hear that understand the didn’t Eric, you last question. part of clearly. I

Eric Joseph

to comparison vadadustat be between to crosstalk motivation going some and try roxadustat. to make There's Sure.

studies. You between the comparators outcome two different have

to You're you versus profile -- using view relative I'm just different competitors speak Epogen, darbepoetin two wondering of ESAs? and the the their the physicians could how if of benefit risk

John Butler

design So, importantly, are in delivered that fact what when think part that's we've today, Eric, and of you this for, commercial to clinical, program got have looking believe well. with commercial is regulatory, we with and first INNOXVATE, data the of clinical straightforward, consistent about and how comparator INNOXVATE straightforward PROXTECT, them the this and we success. and the same data, as clarity for the is what physicians clear, We've and and and step success it us lead vadadustat, for regulatory all is success will how

Eric Joseph

Got to here there well, for just any from well? back potential where the is -- were whether follow-up just -- unable I impacts and sorry, the -- of the any in from is whether readout the come their, anticipate COVID And whether how guess, any impact might any anticipate there's wondering collection impact to COVID back -- to to from pandemic you affects on pandemic, you it secondary patients as guess potential yes, impact I going the in data it. efficacy impact there and and full this INNOXVATE coming assessments, any in in INNOXVATE

John Butler

Steve address I'll that. to Sure, Eric. ask

Steven Burke

protocol. we completion the this and to Yes, soon year, be in the were told met we of there possible, end-of-study phone, wasn’t to as because made and -- and back so, announced done by their last end our patients hi, sites at allowed as any of Eric. visits visits case issue so end-of-treatment MACE the bring No, any by they their we the

like PROXTECT, experience INNOXVATE some we and we very to So in on if at we're had COVID, with we've in the really it the update collect no closely impact data. but but on with still we'll that confident given had come, timing. the feel been feel there's looking ability confident really time mid-XXXX And our obviously we but timeline, it, obviously the need to to

Eric Joseph

for Thanks it. the taking Got questions.

Steven Burke

Thanks, Eric.

Operator

you. Thank

Securities. question from Yang Mizuho next with Difei comes Our

line Your now is open.

Difei Yang

the NDD? the comment carried can is then whether update is congratulations with DD all, on an on give reasonable could think margins to in the of be the what's questions. X first agreement cash -- just the with runway? morning, over finally, on agency that, it was the readout, How and good final reached second you agreement what Phase population, a would about status for should couple Hi, assumption have non-inferiority maybe a on that regulatory we Then us if and Vifor signed the and you Jason NDD question

John Butler

Great.

Difei. thanks, So

So the PROXTECT. the had same INNOXVATE we're using X.XX that non-inferiority for margins we is non-inferiority for margin

So, EMA at was X.X. question. that's and very similarly clear, first the with That

The was? question second

Kristen Sheppard

Vifor… On

John Butler

you. thank yes, Vifor,

to was cash side, with take data through still that. Jason, you that finalized. to make place, So -- to in that? the that's we're still excited very working all runway There able no we're in want urgency happen obviously to on being put very get confident that Feel hand and this in that then and

Jason Amello

Jason. Sure. Hi, it's

on communicated position into as confident cash of our year-end release our with Q runway XXXX we with So kind this our as well, with remains previously and well guidance with feel cash we that runway. a very staying

do previously hasn’t that of to enable us identified given we've the efficiencies runway, pandemic And so that we've which to to And positions savings and also, current that, well us level get situation. to cost changed. also

confident our So we position. feel very with cash

Difei Yang

Thank you, time it is a PROXTECT so regards readout Jason. positive, follow-up And to one quarters? of a filing if timeframe, just quick FDA for, typical the assumption the typically and the is reasonable couple with is lag

John Butler

I'm about… sorry,

Kristen Sheppard

Timing.

John Butler

working hear filing. to then PROXTECT PROXTECT, you already through we we are get in Difei, gating actually be so, PROXTECT, to think is when but that, hands, PROXTECT will to get will for not will work When that filing, we invest when NDA we item. are have able timing we the better I I exact we possible on and guiding want do Oh, hand in the message be quickly that or we as not be -- to with

last sudden milestones we then question. Like have as X be position, right we regulators where to It’s kind front a of multiple possible, a quickly want I to in We so hand, I strong this come are about your and will moving. one this. mean of get other in to of So, Phase front as before, said exciting so place excited set us. we cash of data are be and in that back

Japan data. PROXTECT have approval We and

company position incredible strong the now. So, in right is

Difei Yang

you for questions, congrats and much my Thank again. so taking

John Butler

Difei. Thank you,

Jason Amello

Difei. so much, Thanks

Operator

Thank you.

Our Bert BTIG. comes with next question from Hazlett

now is line Your open.

Bert Hazlett

quite let and and offer congratulations an me you, my as result. well, Thank terrific effort

than of today, a of releasing the line terms others? that top were there if guide MACE all-cause were be readout, you know are could but data helpful? stroke or little that any MI, the that In endpoint MACE stronger components mortality, bit might I you

John Butler

you data are we data But I includes line consistent MACE as today. Bert, efficacy, incredibly most Yes, the -- for well. releasing is safety the This and as all headline components the you safety, consistent. important top across that think and said was

Bert Hazlett

me regard little And with a question you with treatment there same then, you. Can side? thank Okay, was let seeing adverse comments to TEAEs. treatment make the you the to vadadustat. safety vadadustat bit try there like about the are any -- serious serious on utilizing general events It come looked at emergent what lower on

John Butler

I that ask some comments. we pleased the will safety are Steve Again, incredibly make to with

Steven Burke

including overall safety and there cases the positive, Yes, I no very high profile of prevalent think incidents. was was

looked single have seen very that with data a between As long of ago. case groups, had no all we you the we the when difference pleased today. treatment so, I time very, hepatotoxicity, remember safety a And at

Bert Hazlett

be Pharma going more little could effect the the the or of Okay, whether decision that regarding you just more Just to would voucher, just a color review to through you. helpful. priority Vifor one bit you go you use are tree that and use transition? thank then And not question

John Butler

Yes, sure, Bert.

the -- support like consistent. in the final to I absolutely The don’t agreement to a PRV. clean that’s around concerns to done. Like obviously active wait economics that said any will be and with keep that data here and INNOXVATE step that an have I using get that data we support generated clear PRV, on come So, front first get of can’t would It’s I saying, -- regulators. this and the process I will that’s have we and

will conversation and with we obviously that they will but I again agree. have Vifor, So, think

are. excited will about data we I be they this as think as

Bert Hazlett

Terrific.

the slide felt I me the third comment a vadadustat? place need have WuXi if in to on Let could commercial you for agreement you just supply deal, why supply more could, in

John Butler

minimizing suppliers, is of two risk. So, any supply obviously and API we just that actually kind have

So, have the [indiscernible] on API side, we supplier then the API. WuXi, third and and we is for also product, drug have

Bert Hazlett

thank you. again. Congratulations Okay,

John Butler

Bert. Thanks,

Operator

you. Thank

comes Messer question with Chad next from Needham. Our

Your now line is open.

Chad Messer

Good my thanks. add data. morning, me congratulations and the Great, on let

and looks? to how there in been can We get response. comment remarks, your you make guests class point. one hemoglobin on very how this data that hard know great have of physiological and on commented working obviously giving excursion to consistent you've and promises I opening is any this Is the of

John Butler

talked going you what Chad, not Again, presented It what excitement. at to of our we into key one again, for mean That's go and be ASN. it's are will specifics areas. was we've looking that We're done, from expectation, talked Yes. should research, physicians for data, the Spherix to before independent hopefully of level at hear is of new from data. the order me is the with about that QX adopt that And anemia? I it treatment a the in about but data

it physiological dose. in foremost, is and hemoglobin, convenient and First excursions, level, a gradual avoiding increase a a oral

data our as that We well. that that absolutely supports have we proven do across INNOXVATE program development can

from from incredibly feel we're So, like we a positioned as commercial well perspective, a regulatory as well perspective.

Chad Messer

for it's also of maybe partner the your and regulatory to helpful, process when filed update know I course, we the Japan, rest and any available. can it expectation last the reimbursement takes in sort how and That's data to in comment just you look on regulatory Is maybe there, and seeing thanks. get general? forward the on approval of interactions potential launch summer, long Okay, updates And this July. still of on

John Butler

thanks So, the for question.

possible on or We certainly it will to Mitsubishi, product. Mitsubishi as as we're Everything quickly closely with on working approval. to this activities. normal about are said, year. we to if expect the will We launch track there, And be it be be the we've talked working pre-commercialization, be will before, cycle, takes move it -- a partner, will seems PMDA as pre-commercialization our and July launched on move as I XX-month

Chad Messer

congrats Okay, again. great. Thanks, and

John Butler

Chad. Thanks,

Operator

you. Thank

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

Your line open. is now

Ed Arce

if perhaps one very were titratation? down is, mostly relative Second and one two I or follow-up. either to how study to emergent there but for active is, the could on consistent one the drug this data then, more diarrhea, the was level to anything on might or any and studies was the deaths the few for like In then, A study? next lower, you in I particular, you and compares either look numerically, there were first Burke; study? Thank the numbers in soon. with thirdly, positive of either the Hi, you you everyone. those Phase hypertension events, titration that discuss a bit the and Thanks that a congrats And very words, treatment could how and here questions, looked seen the up have look two? Aranesp taking your of see have my in was if And discuss you. at, with for for other me, higher, questions set forward Dr. X, similar,

Steven Burke

had We difficulty a technical Sure. here.

So, the second. the not the I first heard third, but and question

conversion hear question, let remember. Correction/Conversion so I study that two two So, third study. largest with this Starting was me XX almost larger, first the it's much times the

more So, results. put study, study, in the reliable stock the AD for smaller I less that the the table would the and are

vadadustat-treated the entire well, the there in safety MI, when and the the study, all know events the across you and which So, as were in fewer stroke MACE death death you MACE, were they were first in darbepoetin-treated look deaths, primary yes, death, and deaths of patients. was the patients non-fatal measure and analysis cause non-fatal question was the includes the in and majority

safety John sorry. I'm very as the consistent again, earlier, endpoint, results question, alluded this is to and So, around MACE middle the

Ed Arce

enough. Fair Okay.

So, question the second around schedule. was titration the

likely throughout active You study relative either was that the with went and -- or up how schedule? or XXX, I just own drugs its after down and competitor wondering Aranesp, the week-four, up more or likely started more then on to titration was

Steven Burke

still be or am as Yes, titrated analyzing up the titrated the indicated. you data. at last drugs starting and I weren't week-four, they down, could

very was unsurprisingly don't into but to be in you we So, adjusted we a both range were get to that'll that and was presented, target granular clear. know and both, sense, very and doses the it have and were that how with very, key I frequently data, do the for the drugs, titrating able were successfully

Ed Arce

presented the Great. at slide morning, to from here weeks, make the curve, you slide it last the on that just there? one this darbepoetin on does wish there nine you question Kaplan-Meier like sudden deck then look about a me, XXX And comment on events increase is any

John Butler

of nature the the just that's curves. Kaplan-Meier Well,

it's risk. or discourage curves Kaplan-Meier the having of Once of curve, If end event at the you stretches, time, from the bottom slide, MACE for one the and very the when at have the patients middle. decreases event it and long beginning the big of you get I flat look a means people number more appearance can significant you jumps, towards the and the of over study, very but you to the looking at a on would of risk Kaplan-Meier look see at impact end few

Ed Arce

thanks Understood, again.

John Butler

Ed. Thanks,

Operator

Thank you.

comes question from Morgan Our with David Lebowitz next Stanley.

open. now is line Your

David Lebowitz

your at see of see bringing Hello. data how potentially whatnot, differentiating getting question. Well, in data but this dialysis taking you my do versus dialysis so population, they anyway, for this drug dialysis? the is in this thank far, infusions market Epo oral, you darbepoetin, When and yourself the this as look yes, to message with for you what's you're already to and an there going for versus thus used are you

John Butler

in which gradual increase matters we're hemoglobin, course, gave at our this they are data oral looking be look physicians answer you and supports for, difference dialysis physicians, in at think important David. Again, course and the dialysis, related are moving the very dialysis non-dialysis to that those Epo for back go convenient safety all dose look I of earlier, commercial in what then we in home will a them, and in in Yes, as That to patients, excursions, in opportunity patient absolutely know, to. a I levels when you well. the lot of

dialysis vadadustat extraordinarily both versus So, well and positions alfa in darbepoetin any other non-dialysis ESA. or

David Lebowitz

question. my taking for you Thank

Kristen Sheppard

Thank you.

John Butler

David. Thanks,

Operator

Thank you.

comes with Our next MacKay RBC question Capital from Kennen Markets.

line Your open. is

Kennen MacKay

and line thanks Hi, This the all and taking John congrats the is way to question, you to congrats here. the data. finish vadadustat the from getting team, the start for really whole to big for impressive the

John Butler

Thanks, Kennen.

Kennen MacKay

actually, think class, along the CKD exact versus the really So, do validate in really similar you roxadustat, do I ratio. start especially data yearly MACE with Aranesp with hazard same dialysis-dependent those from

on I and Aranesp and have perspective seen you're arm trial, could thinking in the mind, that trial, specifically around how of in arm your the your how control changes that team's utilized out coming that control the love control that here, influence we've of regarding with using active of maybe CKD that versus results and from So, out perspective vadadustat what PROXTECT placebo? really the this pre-dialysis sort

there's cases separately, signals, royalty function one Thanks clinical now mature, a a with law, ballpark on we CKD focus is Hy's revenue you no for questions, agreement? the going data dialysis of housekeeping and is had the how maybe then one seen can test here, model you that were can two with just and other dialysis-dependent of relief, much, financial clinical; much split us just And help and congrats the side, and were elevations financial, to help motor big quick there first, to And Fresenius higher again. Vifor you elaborate, then that be mentioned bed? sort should sales liver so a that which to put any in

John Butler

much, Thanks Kennen. so

[technical of lot to different direction, great. difficulty] back no, -- it's we're So,

it. is possible EMA, designed collaboration, consultation and PROXTECT, heard and active deliver certainly with that's success, from our four I and an we're as non-dialysis PROXTECT, and success, we program, having about the to the all in you've about control was was clinical non-dialysis having want going say and So, in INNOXVATE the again, entire this question across look, years now, is to commercial We regulators mean, regulatory program perspective, your asked and remember, a FDA success, what our me control, or and active this the for, how design we that them, for designed that and the consistent and this about as design.

as Now cetera. it's hand, said INNOXVATE again, analysis, same design, same I same data in earlier, with structure, et the

important patient study, a population, think it's similar all that but we see have about of is different thinking design to that For an PROXTECT, separate the PROXTECT. aspect data, now, I

of what Vifor the is disclosed haven't the we On split with majority Otsuka. is. agreement, the that we profits, and of profit We've it those course, vast we with that Vifor said the keep share

balance the split then and piece Otsuka is between their takes Vifor So, and Akebia.

third to LFTs? talk the then oh, want about And the -- do you Steve,

Steven Burke

had Yes, law there of Hy's the treatment was There the interest. we as special of right, cases study, and you’re an no adverse difference the between event toxicity in hepatic no LFTs, were groups.

at So, no patients of we the threshold, with also vadadustat. was there analyzed, look and [indiscernible] had in certain increase proportion who cetera et above that

hepatic very are ahead, it So, from area Kennen. more pleased very one perspective. go safety good we data, is looked with This the

Kennen MacKay

out in with control, thinking pre-dialysis under going just competing that in as thinking again data some -- to advantage would that dialysis-dependent back similar that one congrats what on it give clean the other about or versus about with the a expect arm of maybe profile, worse MACE you especially if your to others ratio placebo? ratio like Again, and look the real very the thinking could in settings, about mind, players congrats like maybe could and safety Aranesp that in just pre-dialysis, hazard No, [indiscernible] in on active commercial MACE, there? CKD, first maybe better on compare mind an question seems hazard that setting you Thanks again. you

Steven Burke

just data. Kennen. that thanks, seeing from months obviously Yes, we’re few a Yes,

you full more to we data. wait So, I of all design so the have data matters the with see that feel today. PROXTECT, package, next between wish data. we're share We just sure similarity around ASM -- lot, excited INNOXVATE like couldn't and and I it, we're can't could mean, do the PROXTECT but a When similarly with that sharing we to to happy the we be see we was I'm to share I think that data get that we wait it. week, honestly just and

The next please? it. That's question,

Operator

turn for back This call John you. the concludes would closing now like remarks. Thank to Butler question-and-answer session. over to our I

John Butler

the opportunity help significantly joining We the staff. risk team Thanks, future. in to joining these to us. at a all who today. It Again, Joanna, all patients. thanks the has and forward this to outstanding know, you our thank That to want to we patients updating feels I and participated we're company today wonderful mission. investigators for true much support dialysis the want this really deliver today. doing to announce result I that I thank to want started that to in all to of Akebia so the for thank pandemic, the their they innovation are -- as I during believe look is most us a you with we the among patients can and did them. you for Thank to trial, clearly is us data and you

Operator

Ladies for participating. call. and this concludes today's gentlemen, you Thank conference

You may disconnect. now

Akebia Therapeutics (AKBA) 5 May 202020 Q1 Earnings call transcript