Earnings call transcript Q2 2023

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Operator

Good day and welcome to Akebia's Second Quarter 2023 Financial Results Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session and instructions will be given at that time.

As a reminder this call is being recorded.

I would now like to introduce your host for today, Mercedes Carrasco, Senior Director of Corporate Communications and Investor Relations.

begin. may You

Mercedes Carrasco

you financial Thank to second Akebia's Thank and and business XXXX results updates quarter you. welcome conference call.

a detailing financial Please Friday, Investors section is that press website. issued the was note our earlier available August on XXth, and our results quarter of second that release release today,

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

Chief call, Officer; Officer for today's we Officer. Snow, Dr. and Burke, me Butler, Executive have Joining Chief Medical Steve Chief Ellen Financial John

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

release in filed issued well SEC. our that XXth as information section Risk and and the August quarterly we reports with in Additional is risks press describing on as these and recent annual of included Analysis the Management Factors most Discussion results the financial

the only to update The forward-looking law, obligation not any statements any to required undertake as and we on of speak do by or this as call, except this these original statements. of call revise date

our of XX-K our reserves our to As press an reflect to intend quarter on return as accounting release, errors XX-Q. XXXX second identified as recently previously Form recording to to Form reporting annual for the to described amendment corrections and issued financial report due file we the in statements well to related Auryxia

XXXX. and the statements regarding XXXX XXXX XXst, the quarter December company's Please of years XXXX, comments note financials reflect this that for revised financial during the made call and first ended

be XX-Q. XXXX to the XX-K As second quarter outlined Form to described the in amendment the the in release press and Form and

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

John Butler

with and thanks, today. you here pleasure us. Mercedes, be a everyone, Thanks, to It's joining for

work had spent financial is necessary. the that impact extra value don't company. we to this to and material very our revisions together, are we statements later not pleased through We're expected they than little to time the be was the a While that of the

Ellen her past want from weeks to ensure several the but are and hear I we the to that over we as work catalysts. value helped approach thank positioned to best her several important maximize shortly, for You'll team done

focus progress over past kidney with vadadustat. towards few that operational second on patients let's First, for the made the working the through of approval we've months, potential product our disease,

on or kidney for to gain treatment chronic We now US for to adult anemia a are approval CKD clear disease path vadadustat as due on dialysis. in potentially patients a

earlier, meeting our shared dispute the this agency of recent FDA, with our Type from support the drug NDA our which end productive vadadustat of or application we received by new as we've the minutes we for will discussion fact, resubmit and our that end A In quarter. with optimism the reflect

expect we With XXXX. that of from decision March a in the the would resubmission, timing FDA NDA on for vadadustat

an anticipated We the our Steve the year, our initial I'll plans answer have launch call. any line or approved. at next the And also time for with questions for end resubmission Dr. Burke interactions to NDA of FDA discuss here if about

approved Akebia globe. respectively. maintenance products Kingdom associated chronic the for on the markets in Agency CKD in XX symptomatic quarter countries. Vadadustat treatment Regulatory and progress the Products is Healthcare momentum in and in regulatory with our In Medicines is follows the and at tangible US especially alone, encouraging in What's the Vafseo the of team around Agency Commission, the European vadadustat that Kingdom anemia for approved discussions the Switzerland, Swiss EU, United for dialysis Therapeutic United adults past

Europe Akebia new discussed enable approvals worked secure need. credit this bring processes our year. the vadadustat therapeutic our US partner to and outside priority was last To opinion had want assumes in I to on a to regulatory who we regulatory mid Further, secure the to would responsibility year Akebia expects to help a team previously patients option Australia local to that to a in who to end, in for Vafseo deliver efficiently market.

Here signed a met license and we objective agreement again, Medice. our with

a patients is a economic the fully license dialysis and market Vafseo Australia the pharmaceutical treatment the Medice anemia exclusive grants market. focus strategic the company on Germany integrated and The sell Switzerland for in Kingdom, United with in based area, CKD. the of to in agreement Medice with European rights

million ranging upfront eligible XX% commercial payments Medice's $XX of million. an up to addition, aggregate of in milestone payment for net and $XXX And included agreement from we're royalty XX% The tiered an of payments to sales.

situated We for dynamics unique the driven market are access succeed, They and continue country-by-country believe we related their dialysis. to pricing They maximize to the and support efforts. and European to vadadustat. potential is committed Medice understand to

We XXXX. launch expect Medice soon to possible as in as

success the patients US. regulatory we've process represent anemia the US to US would to CKD in the in us eager with vadadustat significant XXX,XXX the market had for in commercial on are our approval An who treatment. opportunity Building we're allow dialysis regulatory due approval most to target other and the markets, advance receiving

is note focused filing. I'll resubmission a very the that

have dosing the part our We'll also data the over XXXX, studies the post-marketing from FOXCUS tens of from past including we'll two collected safety where data of submission patients two of As drug years. resubmission, since received submit submit and thousands original data in Japan, alternate MODIFY.

review. time upon not a Now submitting end NDA again, quarter. review our the working would we're would expectation the we to And is Since the the by commence original was our through this submission. a that of potential NDA, resubmit that data in undergo period expect line, six-month launch resubmission

in opportunity. commercial TDAPA anticipate be new a patients. quickly we'll preparing is for launch potential we potential around for widely of reimbursement, of TDAPA receiving reengaging to likely We're the for which we'd a a XXXX. and approval, file March actively process. available PDUFA date Upon six-month After such, vadadustat expect As product a designation, are the

an the an are anemia, part is XXX,XXX paid for payment Medications used injectable dialysis dialysis patients of care. nearly erythropoiesis-stimulating to with XX% approximately a patients made ESA on that agent for treated are that standard estimate We as of providers. currently in US bundled summarize. me treat the dialysis Let the of to or an

promote to regular add-on patients over dialysis, payment on transitional drug Now payment of for prescribes vadadustat cover a of innovative created top TDAPA adjustment for bundled two would after a the cost the receiving on TDAPA. designation the CMS add-on The drug Medicare use when payment. physician the years

innovative TDAPA bundled still patients. payment payment allow or vadadustat PPS incorporate products their system, into of the treatment Medicare while treatment providers prospective full payment receiving their The like protocols would to for

the for a potential we environment that prepare of launch. product as for believe we And we've a created favorable adoption

Kidney their Vifor procurement the collaboration and to products access in We dialysis with provides through CSL of which to that Vifor have made existing up a that providers. available midsized to CSL includes small for used CSL a vadadustat therapeutic Fresenius XX% relationships, be market would has the network relationship Fresenius most Care of collaboration. and with Vifor through

unique vadadustat for relationship the launch Vifor's within create Together, a experience for will believe market our well environment we pull-through a in if successful dialysis is the are approved. positioned favorable and We centers. we believe dialysis

profit share, collaboration from with Vifor the retain where we remaining the is CSL Our of CSL with two-thirds profit costs a certain keeping one-third. vadadustat, pre-specified Vifor net of approximately

the have the to rights does economics. retain For dialysis market of the sell XX% that XXX% to, remaining of Vifor not we CSL

So these is launch one the I of days get questions on common costs. most

to incremental that incremental. place people needed note expense The launch product are shelf and truly strong additions today as will organization we to have receive a only the I'll also launch here. as most product. But with is position We in we in significant soon already believe related costs the we our commercial be additional approval. we have and the on

to Ellen close management accounting as financial CFO in and been as morning. Snow, put brought who into quarter financial press more position, right Treasurer I'm the and immediate filed return the Now about joined release the month. and team product to on was reserves strengthening that introduce process the Ellen's organization described footing she to process by accounting our this near vast impact expertise the pleased speak our last has our

financial will we in to especially if approved. vadadustat prepare Ellen? important discipline be US the This as launch

Ellen Snow

John. Thanks,

joined significant sheet the associated leverage well potential as saw structure value. Auryxia organization that and First, opportunities to as flows let approval have company's to shareholder optimize month. better FDA me the last say pending vadadustat I'm from and for I upside Akebia balance the cost with the potential pleased cash improving and extremely the towards creating

over as tirelessly have hard-working who worked I'm and weeks we in corrected few dedicated accounting. a errors the have grateful to last accounting and the team talented, identified

are we announced over to in the identified product As close a errors financial related represent returns. errors We the weakness concluded we the for controls process, remediate. internal to and during reporting quarter deficiencies material previously accruals second working

primarily annual year XX-K revenues. to impact the to statements affected and liabilities and the We in for correct to years, financial as which receivable the also our Form goodwill intend the accounts immaterial revise XXXX will prior well balance changes including on impact the sheet returns, our product of report as errors

amended on Monday. We expect XX-Q and our file Form second to Form XX-K quarter

current let's Now move financial to position. our

months. with our operating the revenue. cash million of and of product believe the upfront current was Auryxia least million Total million. equivalents other Cash we second June was $XX.X XXXX, for Importantly, Of in as runway cash primarily consists agreement. connection plan quarter XXth, revenue million net the and Medice $XX.X $XX license of revenue our for payment $XX.X was were at million that, XXXX. $XX.X will revenue XX fund Other

and XX.X% demand quarter to to decreased of net the from second the part erosion. quarter. mix The period The compared phosphate due revenue binder Auryxia to Auryxia customers contracting the growth of caused a shifting payer X.X% was compared over volume and dynamics the is Auryxia timing decrease the in cyclical the impact product and revenue same market previous expected quarter. the first due prior purchases partially to XXXX. year decrease to by of certain in the the increased quarter

Based quarterly expected the is in tail analysis, impact to of had the long believe expected there's dialysis We our market also the market binder binder revenue COVID rebound. community. on in but a evidence we swings but of the leveling, Auryxia

We net a revenue are guidance product in million million. XXXX affirm our to position $XXX to $XXX of

March through key continues accounts, of in and carefully Our engagement continue the on loss remain review of XXXX. focused high-touch a We with revenue to we trends. exclusivity maximizing Auryxia its team

Regarding vadadustat $XX.X in quarter services. as reduced XXXX. to the spending a headcount slightly of to a goods a R&D of than million, decreased from the contract result R&D million decrease expenses, second compared to cost from Cost XXXX. decreased on in $XX.X the goods more million and $XX second and R&D expenses quarter in $XX.X of sold development, XXXX XX% second million of we quarter of decrease reported sold of expenses outsourced

to find efficiently, assignment placing of of quarter. all continuing operating by the have with areas our reducing Seaport We growth ways operating at end and was curtailed scrutiny office on as the expenses taking non-headcount-related expenses office an second the completed lease, increased which more such measures of of the footprint

We keeping are our part levels. in deliberate managing achieved be effort will with relatively to about headcount an flat runway current expenses extend in our which by XXXX

I've team and Akebia, In is spent to individual managing dedicated to the business that to the this as vadadustat objectives. US the made group all of launch deliver the with on clear everyone if from to teams progress continuing the in the provide next our and for time Auryxia it's continues cash on while Revenue are their resources by work we year, across operations, motivated for we've approved. prepare quarter

open questions. that, the for let's With line

Operator

[Operator from Bratzel Allison first with question Piper Sandler. you. Instructions] Thank comes Our

Your line open. is

Allison Bratzel

Hey, for you taking questions. good thank and morning, the

of data? hoping factors first gating any us could meeting, you that frame and high-level will have were And I topics A just then a to confidence So resubmission at for clinical addressed approvable the that dialysis Type generation without resubmission FDA find vadadustat the for follow-up. remaining and the a from just your additional

John Butler

Type attended Steve Sure, meeting. think a and it the little for Ally. A meeting ways. is mean give a was I of Thanks maybe color? Steve, question. meeting technical was the I here lot the pretty

Steven Burke

to Medical Chief agency the describe with it's The them. pre-NDA present you the requested meeting meet like was is and This -- meeting the data where Officer. you're going Sure. Burke, is acceptable Steve a that to how to

for we an instance review, when we like XXX-day update. a NDA finish So safety have

update. to do safety we have So another

clarified, for window the and would in any data be collected And so just reported. new which we instance,

questions going and earlier be So MODIFY them analyzed how we going to what this FOXCUS to to what data, we post-marketing we're acceptable, components studies, that and present were things of the John to going Japanese how would alluded the were to provide actual some modest present, expect surveillance and was as because some is and data asked pretty scope. a of additional of new in the they indicated John therefore about also all that. They III data. of analysis get Phase is But nature. had six-month clock they this wanted will But review we

I want think clarity no we're on able to and and need the what us that. from satisfying have us expect clinical really all deliver new for we're excellent to requests generate there's And data. that and data, they

Allison Bratzel

Got it.

John Butler

was reasonable. the our was from that into they very of ask, questions to CRL even an what pose we the I put approach amazingly need to we year, meeting given Yes. And say kind it that it that focused would of found going last on we through. it, most collaborative them,

So than there's really more clarification else. anything

things much where So filing. are good and we feel track on our for very pretty about

Allison Bratzel

That's helpful.

you then under be if will or walk the launch look good for just and receipt frame that the compare time Thanks. also us could vadadustat? helpful. your perspective could So of for launch TDAPA contrast vadadustat PDUFA us of March frame? kind analog through now hoping the designation is or TDAPA, between KORSUVA's during separately, And like whether it kind expectations there would of just Any for color you experience

John Butler

Yes. No, question, that thanks Ally. for

that things really of to communicate. couple a important are So

post-launch will or product like. product the don't providers the available the dialysis during develop they'll we have and purchase and outside the make widespread protocols TDAPA have the While bundle. product the available reimbursed the is adoption pre-TDAPA really to you until of designation expect for We

everyone. for see dollars, we any be I modest -- be uptake that's and that a expectation see I that clear really it you'll will at If So very TDAPA. should think mean

KORSUVA very is different is I the very as think KORSUVA and The well, different launch one vadadustat. appreciate product than question I a important really asking and a a opportunity you that.

use this about And severe a So I for and $X.XX benefit is me But when the mechanism product the right? use pricing approved KORSUVA than to is is KORSUVA, you product speak when to to continue really to they desire for they'd in to average experience about, When now reimbursed think a physicians number about worry nothing and a itching, ends, dialysis real bundle use is $XXX that the published worry the look that for reasons. well. of product. on well, that patients. no cost TDAPA as which product, about small number to there's BENADRYL, this other for And basis think session. $XXX about cover about $XXX pruritus that's bundled have $XXX, for that, payments per at in to financial a from KORSUVA perspective that And was for session, per a for is dialysis be use you having a you patients. there's to continuing pruritus, of

from So the you're patients could just seeing benefit not benefit. product who

that to of one And successful follows TDAPA add-on so that's to create push we've the been yet. and reasons beyond been payment haven't the why CMS trying drug continued

the the pricing be for in because money set there's ESAs bundle do different. will very right, different, that Now very today,

going certainly the TDAPA. the that session dialysis continue be bundle ESAs, $XXX those dollars bundle and be are While that may to it's be in premium to will in not it to post per

with So pruritus. now going contracting our that, But which may post not change or have They're pricing anemia it's stop right? perspective as anemia, from they're treating to if to not a people doing to treat are not do going TDAPA.

a positive challenge is TDAPA So it more has for very us, been for much a of KORSUVA.

Allison Bratzel

you. That's super helpful. Thank

John Butler

Thanks, Ally.

Operator

you. Thank

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

Your line is open.

Ed Arce

for questions. my Thanks everyone. Hello, Great. taking

have you a the wanted since this meeting. May. First, letter of again number in John, the on about I to Type and I ask talked just A times

get have are wanted issues thrombotic risk the the aligned meeting a letter of that from those May. I how And the about in and And hand events then offered back that thoughts on that in to Stein CRL, now from path was [indiscernible]. minutes them the Dr. two you follow-up. your have the Specifically in with fully

John Butler

Yes.

right, how going I mean on, meeting you of right? fully they're data. give more said, unequivocally, was submit I lot think in kind a as can technical. aligned. to say the -- good kind had anything there we that Steve, to have nothing that I and It's that of Dr. But a I our we you're to meeting mean, I there indicate more always from is Stein. I misaligned labeling, I present of So I with we was about that mean that. detail think sign, was it want that was questions -- the that letter that's received

As I in go mean, discussions. what I I've -- pleased very a collaborative when us those reflected collaborative us again, the of quite with you along, -- the the was meetings. that when you're issues mean we was the discussion. feel It for to forward. fair the for letter are Steve division. of say the get of all I the think it's quite nature in it sure sure describes discussion And and makes quite never that said our think think you path and you And the on to I going focus I was kind into agrees, about and the good quality were path guardrails

Ed Arce

like objective Great. could I'd And ask the included of in the of you having MODIFY and resubmission. then us if studies FOXCUS remind the to

John Butler

Yes.

do and weekly So clear FOXCUS our after our they important times for resubmission, for studies looking right, we filing, approval. that question. weekly times MODIFY have initial have. for three we to reason have of quite safety helpful the it's we all dosing mean, securing be and add to at an basically that's FOXCUS won't data we -- to and 'XX all obviously, label that data approval update when safety the now adding in this originally your will I which the think initial simply filed to MODIFY dosing we you your this three regimen is in data The in have to but be of

considering we're quickly, won't filing, efficacy weekly our know successful. times And them at it So those label. we all, X studies while we and they'll from they in they support be were publish be to think we're working that won't expecting the

Ed Arce

Okay. Great. probably I in, question squeeze on for Snow. one could if Ms. more Actually, Auryxia,

help net gives the described what you what Thanks. given reaffirming Given $XX for market. that million $XXX and decline of to I'm about especially guidance your reach now the binder us if you million wondering half as $XXX sales phosphate a million to that you're confidence year could just understand year. the guidance full you in the is

John Butler

Yes. Thanks, Ed. I appreciate the question.

a D So To if step-up. you significant of are dynamics where that we mix than that of kind skewed towards our say the I a frame being Part our -- expectation years, September number is things. at of a couple There but we be higher, -- our little of sales had an it's would look bit a payer over kind time price sure, the see to bit we December of of expected. more really past has

is there's end -- you would say on But number a our look expectation at more probably lower things when my range. I of guidance as well. So the of qualitative

large was face-to-face think done with more month. could the effective to all I much changed our last at everyone that see and in reps be being when they're people. everything One That's virtually. of let can haven't And just the sales reps agree dialysis sales providers people in

as boats helpful and you we with monitor flattens need as -- as product all we -- still funnel, think, well. of as lot it one mean and is So I if think, the of the in right? of competitive of number of that And of flattening, there. think well under I that continue lifts dynamics. they type be I binder obviously, it think. year that other as This those there's be treated, that's will well. this, to kind Ellen pressure, also expect opportunity patients still tide be types rising to a we on in focus to back moments half the launched expect is market phosphate come as to And has we'll but this control, will, said, come, we but a been And So those

higher I think that issues I where of I I earlier in that types number would would a of more the albeit lower think So to was of end. say maintain the allow towards range year, there's those the end expecting guidance that us the

Ed Arce

helpful. much. very Thanks That's so Great.

John Butler

Thank you, Ed.

Operator

you. Thank

Harrison Our Julian with comes next from BTIG. question

open. is line Your

Julian Harrison

you Congrats Hi. the progress Good morning. taking thank for and my on questions.

I'm your curious First, the again, vadadustat this label about three talk maybe just dosing for you how be potential soon amended with if FOXCUS. times dosing you could regimen? there weekly regimen, on and strategy studied more a in

John Butler

Sure.

Julian, the So for question. Welcome the thanks, to call.

patient, center, with weekly don't them patients times ensure three during right? treating you the at in So for compliance give dialysis have them the session, You home dose dialysis from is helpful drug. very your to you send the

So could in we've something to the felt that was important that, that that's add launch. potentially never have the expected label we something was to at and always that we that it label

We will publish the data.

expect, FOXCUS was that We dosing. it who just and them a day from doses course, three in And weekly about home Again, where the they'd the where adoption use when presented low-hanging are patients times have three with where at we've to NDA the provider. I times then dosing. approved And FOXCUS. once them dosing. expect of weekly weekly for you and October ASN daily the at about it's that on as once been the they're FDA publication the really product study supplemental and about looked I send NDA exposure home think March, in-center though initially, choose fruit in we on we'll and high fine. or we'll the large to dialysis have rely as willing be three the submit the a talking our well meeting works even Then to for conversation of drug might ESAs those added be patients, dose think, be times patients of to doses a ESAs would risk cost say having of to dosing highest

be but And promoting to in that wouldn't data choose weekly have it's we something dosing the as certainly times our we three regimen label, we do start times I the dosing course, to as that's as said three our to that physicians then will label until can with quickly added can. weekly Of supports it.

Julian Harrison

Okay. a overview in current call, gave on great commercial the you Got it. earlier your preparations. Thanks. That's helpful. then And

Sorry if I potential curious much it, at was missed of but I talking how manufacturing about you're risk of just all if approval at ahead vadadustat. you're

John Butler

question, for Thanks Yes. that Julian.

biggest product our I Remember, costs the data As done a product to mentioned, and has job and are people product two one. that generate team expiry launch out and back And years. had to is last a date shelf on product push able really the we're of ready to to we quality significant four magnificent on the continuing year.

shelf on to will product that that's today our able launch. the be So support

going have that to the don't and also And that support and drug. any course, take to ready incremental we incremental is do European So Medice drug be well. manufacturing launch launch cost the of to as to

Julian Harrison

Thanks hear. again. Excellent. to Great

John Butler

Julian. Thanks so much,

Operator

you. Thank questions. call further John to for remarks. no over are There the to turn Butler closing I'd like

John Butler

Michelle. Thanks,

is and we strides need that to progress the are be to pleased patients. excited momentum, get anemia with to if Most The the disease. and motivated approved. catalysts. is the impacted last dialysis made in help do Akebia immediately, to we very we focused potential next of We're position in We launch people look vadadustat With poised by the we this all we of vadadustat future is approval disrupt potential for to the month. for you Everyone near preparing continuing the resubmission work patients vadadustat as market you team And believe purpose remains now the update are of to there. on at of NDA our and Thank extremely for in the I CKD ultimately, we've to us as better in today. US. through potential us our by kidney resubmission, very lives move acceptance to forward joining quarter made near-term the towards significant

Operator

participation. does and a your now you for Thank conclude disconnect. the may Goodbye. Everyone program, This great you day. have

Akebia Therapeutics (AKBA) 25 Aug 232023 Q2 Earnings call transcript