AKBA - Earnings call transcript Q3 2020 | Akebia Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Akebia Therapeutics' Third Quarter 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.

Kristen Sheppard

Thank you and welcome to Akebia's third quarter fiscal 2020 financial results and business update conference call. 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 III program quarter available Please that on Relations third our release earlier this results to detailing Investor note issued our morning press the the was and is website.

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

Joining Financial me is call John Butler, and David our Officer for today's Chief Spellman, Officer. Executive our Chief

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

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

John Butler

call we'll detail. mainly anemia treatment the us the comments turn for I'll over on data We then Dave the will today's to weeks for And approval our conclude presented briefing review of regulatory US CKD. all with Thank an you the to some submission two vadadustat focused joining today. ago newly you, due results Q&A. And quarter. to for be to My the call over the Kristen. financial thank for in of potential in short webcast held go investor

this community and get challenges the performance, year. significant started. Especially unwavering patients our the serve. Akebia ongoing And I'm we has their that, of progress COVID-XX the team's resilience, that made by proud global kidney pandemic. and with let's presented given So to commitment

Our we're importantly, to We a meeting through long-term believe shareholders. Akebia Akebia with will dynamic pre-NDA deliver history. believe strategy we leading team value period the for And FDA. positioning that its our on in recently is we most the build completed our

and well while and and or both the of MACE vadadustat our important A primary next vadadustat milestone, data for this possible the as above and to and data global to the achieved target remain data More May clear safety. that as maintained the as specifically, showed target of FDA, secondary more shared minimizing both primary endpoints the endpoints we achieved Following we Week. key III the track key patients showed our year. ASN on and Phase as INNOXVATE efficacy recently consistent The then which across excursions vadadustat efficacy in from and hemoglobin were submit key that range, secondary Kidney positive range. early safety data announced NDA is program component at These the this NDA in first dialysis, program.

others. in significant approval, marking potential already of opportunity as expanded achieved vadadustat oral patients. care believe treatment opportunity complete European NDA addition, Authorization a our INNOXVATE next in close US on remain Application believe advance beyond Agency of our that path approval to patients And pre-NDA we for to CKD alfa to prevalent the meeting, and key dialysis we iXn on our the commercialization as Japan, on the a to confident support and a endpoints vadadustat both reimbursement Akebia dialysis. MTPC, adult their name VAFSEO. believe the these to to say coupled for patients it market, supporting treating We're all-cause cardiovascular in and included us look Upon Otsuka promise prepare not with forward adult We available this and new to goal. the regulatory all into under represent in treat more as Based could unique label market to Japan, as These And forward our to a opportunity monetary of submission We to is more pause expertise the in I'm patients on dialysis of innovative achieve US to in for a here go-to-market billion Akebia. unmet future due kidney costs vadadustat MAA nice with help dialysis to look advance due to of US for with incident with US, mortality, say first the quickly is $X disease this leveraging both strength on have we safety enhance commercially secondary upon is places vadadustat's launch data anemia XXXX. standard commercial results of with the as or and Marketing our mortality. partner renal well potential We with nephrology A rewarding XXX,XXX see an a worked partner dialysis, dialysis strong launch or adoption major potential even a in Which a following incredibly to broad significant with the the on in potentially we're pleased equally enthusiasm great existing darbepoetin to anemia submission this focused on both mission an and In cardiovascular to early our our on NDA. and on excited collaboration needs like bringing that vadadustat vadadustat milestone Akebia that and approval. CKD We MACE, on MTPC Medicines track to therapies. vadadustat's address significant encourages dialysis system encouraged and chronic that our MACE, Japan it's trade of opportunities extensive to dialysis. subject believe also strategies, market. patients of structure milestone our by I'd possible we the the of underscore as they care teams. we plus CKD continue to success including in positioned segue for collaboration and the confidence and very the is unique hard we're the a the potential how alone. believe in people commercial example organization dialysis we working translate anemia with on dialysis patients where responsibilities and to this and to realized to due possible dialysis year vadadustat straightforward approval. well where reimbursement its already the demonstrate I'm Otsuka with the And Otsuka. the sharing meaningfully market as partnership, team in to market are vadadustat and in in

manufacturing increase on And continuing recently from for to a all streams highest disease place affairs, launched readiness this communications, care and XXXX partner a medical priority be of state for beyond focused areas scientific we're education, NDA, of cash anemia Otsuka, of to opportunity healthcare financial execute CKD. on a unmet comprehensive patients. our across launch with strength. to that of such in to among management education the patients need pleased upon we the promising this our significant CKD vadadustat. in with due expected Together Again, dialysis. will our approval. different commercial patients And advance a disease awareness many services, of vadadustat designed as Dave providers, standard the ensure see to we a campaign with among all goal anemia submitting of as runway discuss, to While we're US extends remains and work the due there's to doing of patient improving With

pre-commercialization our commercial medical continues a executes vadadustat's our on potential support team While team with activities, robust plan. publication to

to the INNOXVATE it's be sufficient of global at CKD submission. as to full the The look well of publication, forward. other review prestigious non-dialysis addition part also whether NDA dialysis. approval opportunity. expected, also as data like reviewed syndication peer anemia moving data A on not of our pre-NDA confirms to will our we to as the meeting forward support many to FDA the need of adult publication determine publications due a all in of to in I'd patients III treatment In presentations for non-dialysis to vadadustat Phase that, will our on the data we ASM, touch

well. our And in cautious suggest non-dialysis appropriately we in are being you for are we the So as outlook indication. approval

based we in to non-dialysis pre-NDA all impact of treatment vadadustat summary, interactions, the therapy of strength issue given care potential including has meeting, market the in this subject forward confident dialysis address unmet US will our believe bringing is and if with our on the Together of on to on CKD billion review to globally, of anemia remain the patients of with this standard anemia of not oral on Otsuka, due for look the provability with help Importantly, currently a adult potential adult opportunity CKD to dialysis. regulatory patients approval to dialysis, new In the innovative approved. this we to a needs to due the that our data, $X of alone. be that collaborator we dialysis vadadustat patients

Dave Now joined with know. I'll in CFO in think Spellman, many Akebia companies. back call to an I brings you and July extensive commercial background turn our who him over the of Dave

have very him are board. Dave? We to on excited

Dave Spellman

quarter And to collaborative the part good people After pursuing knit tightly you million, like I'll company With it's revenue deeply driven all to the quarter and been company vadadustat Chief say PROXTECT results. excited lower with Officer, Akebia's third compared million XX right John decline held we really the to to studies. $XX forward development just consistent speaking more to as jump my lives to the in and the a period was people you, for a completing both to quarter's third Thank talented completing advancing of with looking program. Akebia of everyone. better INNOXVATE advance here. of quarter of revenue was program mission kidney vadadustat I'd impacted of XXXX. the continue XXXX of I'm in into Total by first that, versus be be so, Financial how disease. both community and I'm as our by The morning for a development full prior the inspiring

collaborative as our revenue. XX% our development and are III Phase know, corresponding of are may Otsuka vadadustat costs by collaborator you recorded these As payments reimbursed

costs these vadadustat regulatory so from as payments. with Otsuka that terms of has to approval upon payments potential of the Europe. subject on milestone the in corresponding collaboration So note, development the Akebia decline, our the to will and both US in agreements Separately, and Otsuka, receive

mentioned, in the Japan. As by VAFSEO revenue late related pleased early We're Japan. the meaningful growth recorded VAFSEO marks John the under Japan represents I'm and pleased of we performance sale launching in with Tanabe that Mitsubishi commercial to vadadustat. for commercial partner the vadadustat name royalty opportunity August, since to third believe this that in first continue availability our a $XXX,XXX collaboration report trade quarter in of to

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

writedowns, we While of uncertainty to for as have on the from CMS' planning encouraging September this million the cautious associated that a remain as three in includes Auryxia with to million Auryxia. previously manufacturing our was months Cost with to of and goods decision non-coverage revenue Auryxia largely manufacture $X.X the business well performance, noncash quality impact of sold in inventory due continues COVID-XX. issue impact our XX, disclosed ended is XXXX, $XX.X related for fundamental the

of quarter for R&D quarter the and million million of the XXXX $XX.X Moving expenses, third compared development to were expenses $XX.X XXXX. research for to third our

US decline cost was by the consistent the general the with here and I XXXX company higher million PROXTECT for result of introduction of of million pre-commercial expenses and for mentioned, primarily the was approval. just primarily of related $XX.X the quarter administrative to some subject Selling, fees increase third third As under way compared support service in currently to were a INNOXVATE studies. a completing activities the decrease the $XX.X XXXX. The to to vadadustat's in driven professional quarter

potential patients potential expect to We see vadadustat investments to to future where opportunity growth. in significant with we our in help patients continue on drive focus our dialysis, market and

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

the in of to for million. and XXXX our quarter position ended equivalents of cash financial third Turning position, cash, capital $XXX.X we a sale with available strong securities

plan million We open expect with assuming we'll line for And vadadustat, shares our outstanding. current our ended beyond launch the fund cash the lastly, questions. of expected operating approximately XXX resources to the we quarter Operator? regulatory US that, With approval.

Operator

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

line Your is open.

Ally Bratzel

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

on first analysis. regional base just the PROXTECT So

that a understanding presented have continuous wasn't we cuts strat plan. data the think at it's been expecting pretty the change in regional rescaling power, from And PROXTECT variable but for MACE would ASN age I pre-specified be to specified. a analysis our the all increase dichotomies actually that the

could FDA also, analysis remarks, will So the pre-classified comfort just mainly then get just prepared is than hoping you non that FDA like how rather pre-dialysis. And from interested it you your sounds talk regional and base in accept global analysis? about

expand right? maybe we And could you So hear us help on how just that? do that

John Butler

Thanks Ally. the for Sure, questions.

to of call, it's analysis, ages at model. comes old over part to if had recognize important kind looking variable young, the pre-specified XX continuous now it versus a that SAP age when to dichotomies So you And continuous of old. want the was the

Now you using continuous tool age - to a specificity. variable continuous as the give the more is

is normally it run. way it's So the actually

not not risk. a have hazard you a dichotomous it data. at safety X.XX, different. top and X.XX And you're as that variable, as there demonstrating look a ratio you're at of a This increasing continuous– what meaningfully you ultimately is end cardiovascular If is

to that sure you're want what I Now I interpreting correctly make said.

an recognize FDA way not and we're we approach clearly for as the primary put we're missed think We that - going that non-dialysis, significant but path the forward regulatory that presented to feel that frankly, in meeting on pre-NDA at we've And of And risk. confident is What that, this in deliver INNOXVATE, today with dialysis they and there's population absolutely that message best in that to safety think a what and, as a it's based just interaction our really is endpoint. in every have confidence well. front to we analysis we dialysis. all very data, given had, given separate I important the risk-benefit. we on we separate data you it look the our for And

Ally Bratzel

just maybe question. more And Thanks. one Okay.

your for roxadustat to Now that have changed? you've in thoughts had maybe for pre-dialysis Adcom is all with the on decision just and dependent view, the for even in month? the at your chances this an pre-NDA or related clarify, meeting next vadadustat FDA, non-dialysis And approval

John Butler

I on mean, roxadustat. can't I Yes. really comment

had that very working so. been going confirmed all there kind constructive, a pre-NDA happens we're six Honestly, weeks know productive think we of that I everything is simply meeting already. really to what or in meeting the toward

We would course, But vadadustat an are think, that benefit an we that dialysis, treatment think with on it our Adcom. up FDA. get the preparing of don't from for But ac. been describing So always that's, changed welcome I we Frankly, an We've patients view think Adcom. to all. for be at would we important. preparing the and

Ally Bratzel

you. Okay. Thank

John Butler

Ally. Thanks,

Operator

you. Thank

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

open. is line Your

Alex Bouilloux

in if could on dialysis Alex apply be expect still regulatory following secondly, how is I'm everyone. could for to able a Good Priority whether for early for of Thank for vadadustat. I'm on you to us taking Hi. if TDAPA This plan the for a you next Voucher then you setting. morning, Difei. question. using on the you. potential you year wondering approval filing Thank you quickly give wondering Review approval would sense And comment

John Butler

Sure. question. for the Thanks

we use the option to have So still the PRV.

our not and before, decision to course, on our that's That's agree that. we partner Of alone. have

discussions those So ongoing. are

that. So we'll yet determination use as haven't we made to not whether or any

kind once - you - I you basically, TDAPA. the as of code it of approval your and process file they on to kind the quarter, the TDAPA you depending do part when a need there's far that - approval this HCPCS grant is when is As of think, goes, they takes have comes, the be once

able approval, clear we'll approval get closer as to we that a when knowing So go But you process get little that about part depending for months - code on be to exactly of will approval. granular when happen be there's a be more your be. how months some you There to getting you delay. TDAPA. get doesn't will of need It of instantaneously on so on

Alex Bouilloux

you. thank Great,

John Butler

you. Thank

Operator

you. Thank

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

line is open. Your

Thomas Yip

of is Ed. This Yip Hi. everyone. Good morning, couple Thomas for a asking questions

First, dialysis on the the Do in non-dialysis half for separately, vadadustat first vadadustat patients on about perhaps patients. or of half PRV, does the And the together in expect and you they to XXXX? come questions play? in of one PRV into are filed them a indeed to couple second how NDAs, following file question if one

John Butler

Thanks for the question.

this the important the one is as that both for populations just application. very both of and for FDA to drug determine part one. one NDA. or new will And population can The the note, is approved drug include So NDA non-dialysis dialysis

be your next planning So me our the determined point question can decide it's not, that as PRV one year. - along to out, early on the or of, I as filing second use And whether I makes mean we moot. partner, on kind we're NDA. think, it with let will we

or half. get that we move beyond of guided going that, to We're to haven't done. first We as second can idea this quickly as

think to look don't that filing. far out you I too So should

Thomas Yip

the for submit population? needed Did else non-dialysis NDA? additional meeting. clarification, is what for you on, the request can the analysis understood. And following And if Thanks and the not, before FDA I pre-NDA on Okay. then any

John Butler

There additional there the additional book part - versus what analyses be any the are briefing pre-NDA analyses. will they is of specific I I meeting don't mean it's NDA is the for the NDA. receive different. that the are dramatically obviously, think

the support we're include analyzing NDA, We're So we'll if those still those. data. doing the then still And analyses.

Thomas Yip

on it. first, congratulations And Japan. question launch Okay. Got one Mitsubishi the then - final with in

So we August. launched year revenue this already, of was see royalty and from in that there's a million $X.X that investors

month it's of about a So sales.

And XXXX? the fourth revenue look we in at should quarter so sales royalty how

John Butler

Yes. Thanks for question. the

as pull-through So We're a quarter gives build. guiding inventory royalty. any weeks is Four, but some month. that direction. are some Calculation, there sales yes, But of not five launch, about that the bit that it little would there is is sell-in. to expect of and in with hopefully, amount, you you a fourth

Thomas Yip

got it. Okay,

John Butler

I think launch. I would with characterize our is partner pleased the

are as well. we So

Thomas Yip

on Okay. for launch questions, to you and eventful And a Completely forward understood. the taking for in again, look Japan. us. very congratulations once Thank the we XXXX

John Butler

well. do you. as We Thank

Operator

Thank from the Our [Operator of Hazlett Bert question BTIG. next comes you. line Instructions] with

line Your is open.

Bert Hazlett

addressed Thanks slightly just Mike. got but regarding non-dialysis of question, for different necessary? taking other any interactions mine that's Yeah. the sense was there requirements the than be been just specific asked. that In the were one have what would Most your FDA you just population, with

John Butler

Bert. No,

all to it that understood needed they to then review anyway. were understood I do. it pretty other things be feel we're lot would As - I much and some going I significant it mean presenting that I I was they it of on together, were was analysis also, - them - said, there things got technical mean, they of small like we of that and a we they to what but be and were submitting there's was said we nothing together all like but to clarification - no - constructive mean we going

things. that to we had So of change communicating much was a of approaching before. there that the we been very was big or kind came It's out were you as surprise nothing for way a that

Bert Hazlett

just Okay. Thanks. on - spoken And one partnerships. you've other

environment? Vifor the with You've and having in about spoken you Mitsubishi. a couple of and this Can you're in Thanks. different general, your characterize times current Otsuka partners just, interactions

John Butler

were them, I the incredibly point NDA. They obviously. lockstep the but are interaction I'll on we've Bert. with from Otsuka are the we are directly Obviously, are we're we with leading pre-NDA we partners for Otsuka on the chosen. as the most the They'll NDA. since mean MAA, call question. mean, most them I Thanks side-by-side pleased - Sure, standpoint. leading working to that with the representatives with kind of we a well. be us strategy have

been through obviously and work aligned, Our throughout. they've I day-to-day fewer process. have But great with, say, the as Mitsubishi, in before, strategy great to is they've but with just interactions kind we of been

Bert Hazlett

Okay. you. Thank

John Butler

Bert. Thanks,

Operator

you. Thank

Our of the next question line comes Company. Chad with & Needham Messer from

Your line is open.

Gil Blum

on Chad. you taking question. Hi, for everyone. Thank for is This Gil our

at kind would they ask previous FDA FDA might the this indication in you no you so that large. be is the FDA, this mean studies there's of do? studies have addressed not feedback, Although non-dialysis the additional there with looking any performed to against already, that I would

it's direction. valid kind a of So

John Butler

Well, there understood that was no for I'm But meeting that extraordinarily mean in I pre-NDA say not be I of the understood But the meeting. that comparison I be, will expect I question, exactly again, not sure a be pre-NDA sure unusual characterization any I additional that but necessary. would would question. I'm to nor studies there a what indication,

Gil Blum

the say, non-dialysis in made because just your study let's is in dependent. roxadustat active than, It's in different control studies

John Butler

Yes.

Gil Blum

differently. kind alluding That's to. FDA was the this at is what I of looking Maybe

John Butler

want I with direct what This Again, asked they the them. guidance we that for what mean, we see think comparison. the Yes. the we results did we're - of why FDA. the and I they And did, giving you is program

to to together see with we've data. package the on we'll we're put our ability the here. an things we done, in with non-dialysis. based we're pleased certainly But approval again, So and that we're cautious that have out are roll comfortable how the able again, But program about

Gil Blum

questions milestones. you upcoming with all good all out luck Thank answering right. maybe for - and All the

John Butler

very Thanks you. Thank much.

Operator

you. Thank

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

open. is line Your

Victor Ma

questions. Ma Hey, couple questions. is Victor on guys. our Thanks This for for of a Kennen. taking had We

than x - else events. XX correlation US the to US better to stood on XX the treatment ASM we it's for just the trying And presentation there XX, just cardiovascular range differences that versus out of difference events? Or other you be to to versus study, guess understand this to I first, had is XX they between US anything and PROXTECT driving hemoglobin patients. higher did range, patients achieved just are what in So any between trying which we're x the you of that from higher hemoglobin cardiovascular see the US better could outside understand data? and

John Butler

a geographic reasons It's question. different one rest and of was of why And pre-specified pre-specified the the great in mean again, I analysis was a the that's it the a US hemoglobin analysis, versus target analysis the because world. there's

no data, we analysis right? range so hoc target show difference to And that looked patients XX. why US were by in driven I of MACE data, the the patients to a performed treated of who kind post we at mean That's the hemoglobin the XX XX, during x was who range of XX XX a you versus they managed within there risk. lower had the efficacy cardiovascular were actually to same to saw primary hemoglobin achieved If effect. over level the was they under endpoint increased and that XX, -

hemoglobin. the of showed higher risk increased up with All you patients treated when cardiovascular

we've if that it that's to lead patients So the that NDA. put argument treat the front us increase - a And we to in the which conclusion the will risk. of is hemoglobin put target cardiovascular US, XX XX, - target to the you don't with does the the really is FDA of that in you

Victor Ma

pre-specified in curves control a IP I'm think There's in the and just I that, on US, up follow are vadadustat to for the US the the happening analysis at just week split curves looking between And the sub the XXX. helpful. around Super Okay.

you could Or driving that that? anything why there saw comment point? the that could on So is maybe curves be that splitting you are at

John Butler

thing come that's important risk No. again. overall together - not split, MACE, I see maintain I they - look mean mean, there is back and unusual increased the clearly there. non-inferior. that's a to cardiovascular That's you where there's the something don't at they when that no it's is why

Victor Ma

driving cardiovascular could - is it. was if drug like exposure me terms Got that maybe if of be duration events of I'm the in that's the thinking wrong, I or of something happening. correct just

John Butler

you wouldn't mean if it I case. the not. come it's was together then that back again No, see

to you what is smaller. I start think start ends the get to that see

so back - ends in kind And come that that you to the risk the in even demonstrated. when smaller population. the an all cardiovascular separation. increased statistics is together of there that start fact they of And is see But not that demonstrate that's

Victor Ma

you progress, so thank and it. congrats so much Got much Okay. you on Thank the again. and

John Butler

Thank it. you. Appreciate

Operator

Thank you. now. I'm closing would to like the queue call no showing for Mr. further the questions turn remarks. to Butler in over now back John I

John Butler

Thank We you, morning. update continuing us Akebia's this look day. thanks to to joining and for to everyone Tawanda Thanks. forward on good a progress. Have

Operator

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

a now disconnect. day. You may wonderful Everyone have

Akebia Therapeutics (AKBA) 6 Nov 202020 Q3 Earnings call transcript