Earnings call transcript Q1 2023

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Operator

Good day, and thank you for standing by. Welcome to the Akebia's First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

like Ms. the now your over would today, speaker I to conference hand to And Senior of Carrasco, Mercedes Director Communications. Investor and Corporate Ms. Carrasco, ahead. go please

Mercedes Carrasco

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

note of May detailing that our Monday, release website. Please earlier available in results, quarter X, a was our press issued that the today, financial is first and release Investors section

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

Butler, for Chief Officer; today's Spellman, call, Financial me John Chief have Joining Dave Executive we and Officer.

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

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

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

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

John Butler

for all us. Mercedes, thank and Thanks, you joining

the therapeutic Europe with Vafseo kidney to recognizing with as vadadustat accomplishment in dialysis and I the associated anemia. the are approving countries. adult making. extremely this We're is market that's on a for and European authorization anemia additional an delivering want on Last dialysis. in an treatment symptomatic patients XX chronic Commission The today bring product to to proud headline been is oral beyond, now in that option patients begin approved by here eager of vadadustat, Vafseo, to month, milestone for exciting years in disease granted marketing

treated currently and to partnership who dialysis anemia process complete We're our understands in that and priority Europe I'll Europe a a dialysis a Vafseo priority market running of patients look the will to more forward year. complexity the end, company than partner very a is then to to late that truly note them a CKD. across for with the in To Europe for quickly our make of Vafseo due that this announcing launch are Europe across active collaborating with support who we XXX,XXX

Again, the not without for would our and have team. approval an was important catalyst been possible it dedicated Akebia,

summer for If to also to commitment on patients we proud last demonstrated physicians, responsibility who grateful I'm and clinical our investigators for team's the the remain authorization the recall, led you Akebia. in trials and worked approval. participated the to for track psych assumed to marketing application that approval. I'm we of coordinators and patients,

our with OND, the of U.S., letter, XX Last or Stein, as Drugs, Peter has our within time, Dr. OND, the Director the Office met we our work to on internal Drugs indicated appeal within of he with deciding that a approval vadadustat or days. on towards the the Since appeal. the anticipate response his with remain and discussions CRL. for and quarter, authority Dr. continues, a In engaged next completed of vadadustat New we potential Office Stein the New complete response we experts

the benefit indication. potential disease kidney believe for We that we for market chronic vadadustat as and continue to in anemia overall treatment to the in due deliver a opportunity can believe

vadadustat kidney data converted who anemia. the comparable secondary time the treatment primary vadadustat treatment dosing with maintenance study at acting three results in fact, and top-line standard disease an a efficacy on the we in announced hemodialysis dialysis inferior times demonstrated patients erythropoiesis-stimulating week last agent, the profile from for non of ESA, of current times vadadustat used weekly a patients dosing to an ESA were the in positive from and The of or long a chronic three month, alternate to In care. was and safety to safety when FOCUS, that evaluating oral and to hemodialysis due endpoints efficacy the of met anemia of

the as a top schedule, Again, want if We three sincere with visits, appreciation patient -- are involved positive top-line this and dosing believe weekly important, times everyone we the the for approved are very in-center significant this hemodialysis pleased our to undertaking results extend to it ensuring is I was vadadustat in aligns study, dosing because results. a compliance. with schedule

acute that evaluating we for to enroll respiratory You'll ARDS recall distress broad work continue working and with a in last patients vadadustat ARDS. UTHealth, population to update, an a adequate design or patient our initiate with we well-controlled to year. and as expect syndrome, treatment Since study we're also confirm I'll this UTHealth

of on our decisions plan. enabled better business our there people We know kidney to strategic by our live Our our potential reporting ahead near we them us to has catalysts focus against strategic forward are and as term, we lives continue look in purpose to adherence team's impacted many to up to the strategic disease. the to and execute

I'll talk And with Dave financials. ask more to about that, quarterly our

Dave Spellman

John, you, good everyone. morning, Thank and

guidance note that revenue I'd million. $XXX net affirming are $XXX annual revenue. to by to important begin addressing we like It's Auryxia of million our product to

channel of reduction significant While against last the move tune approximately was inventory, noted million. inventory increase partners to in Auryxia significant selling quarter in our there quarter, at a a this a $X with us we large

anticipate XX.X% contracting dynamics, in bumpy. little XXXX, revenue $XX.X million decrease. of will quarter bit product net was We Auryxia compared XXXX in performance be million a current quarterly first quarter with $XX.X of to first that the a the

ago. price tablet three higher per approximately XX% than realizing higher are We years a net

changes As in more much a are now result, the in inventories channel apparent.

the sold Cost decreased period XXXX. of goods in versus same

of goods would at asset million through of include which call, Auryxia, intangible I what now, XXXX. $X normal a are will cost non-cash the We cost Auryxia quarterly amortization for QX

reduction quarter realized a in nearly I expenses, XXXX our reduction from extremely In XX% area an of XX% operating of review the performed we believe the has operating first expense team I'll fourth of quarter quarter XXXX, that and XXXX. nearly versus the Next, first a well.

diligent Our Rather team into last remind will and diving costs. overhead. comparisons, further to of months, to than reduction actions in believe we XX has a be sustain the valuable spend the efforts its taken while the folks it manage to I in reduce our diligently been working over have operating

our reducing of support headcount less commitments reduction other actions important as of consultants; while clinical reducing as office historical strategic reflect to QX more a creation and contractors than of well from of space; still current reduction several and needs; Some XX% supporting include: functions; those supply and our programs; our down spend XXXX; external on of several ongoing value activities, winding third having accomplishments pillar. our by chain occupying better activities

As will for months. revenues cash, next at allow $XX for our business ended and in hand. with We cash XX approximately Auryxia to of on fund million continued least with the our execution plan, our us our cash the quarter

debt been million, the year. reduction a reduced $XX to the has position XX% Our from end of

liabilities. We have significantly our reduced current

also and listing. want NASDAQ our to I stock price address

the receive materials increase stock. split to we reverse stock Unfortunately, of The outstanding to compliance, including a was filed amendments stock compliance a year. to the bid minimum out our split of NASDAQ. know, purpose over rule the regain rule earlier have an regain common on price stock of minimum our proxy many not and trading In proposal imminently. anticipate share reverse stock, compliance a we effort charter, listing common a and primary proposing common the with for our will effecting per maintain pass NASDAQ's so our year, proposal to As we notice of to for that been price this price we with as bid effect delisting the did

While will NASDAQ is accept to we days. no delisting, completion than way listing the to of that appeal for successful. be less either a rules, the NASDAQ maintain reverse the plan no only $X.XX over business process split to to the consecutive there no is XX obligation Per appeal a or through trade appeal under appeal organically to be assurance and the upon

a if the proposals majority split. We our supported the NASDAQ listing. in our reverse of shareholders the the the a stock reverse process, of does find such, special meeting plan maintaining currently approval regain not at proxy seeking compliance to split stock appreciate that voting during stock new As value appeal file organically we statement and

In could that the business we continue meantime, come from as value our catalysts. operate recognize to usual the near-term potential and

our of progress are the new strategic our since We extremely established we pillars. proud last year over business

with I'd have us a of recognition here. got who Akebians close like the all to

line the open questions. we'll for that, Operator? With

Operator

Piper [Operator Bratzel you. Sandler. first Instructions] Allison from question will come Thank of Our

Your open. line is

Allison Bratzel

taking Hi, thanks. my Good and questions. morning, for thanks

FDA with the when answer you from help FDRR did or process. within follow a vadadustat least XX-day So understand an first, you've just at just Could And clock that Dr. what on the extent the us communication had of have get just you to gives And process, ups. Stein that start, can? couple the XX I confidence days? clarify, just on you'll you

John Butler

Ali. Thanks,

there FDA regular there's meeting quarter. with normally an we We as And during review. Stein that formal in the contact. been with manager is mentioned Dr. a we've So, A had project type communication been last regular

it's where days. And think more another so, don't we -- extend it's to into expect that within really it's days, say. insight questions, possible ask go. to and XX will answer we right, that XX Stein next have from what But he'll Dr. recall going communication don't an also but have that's it that We

about the don't believe what and, to we that feel that strongly communication of going information is should he -- a be. where course, have any So, make to has that decision insight we while into decision go, he that's really we needs

next forward well. communication of XX as sure to seeing and, over the I'm there'll be we're looking course, ongoing days that So,

Just that regular business. course of

Allison Bratzel

help that on Got what there table helpful. on could That partnerships the can visibility be then progressed just approval of the have a on Europe? would just in And kind any you partnership? in how the discussions have kind there? clarity you for timing And be those understand us hand partnership, Thanks. or And now EU of it. just

John Butler

a is very It process. Ali. Sure, active

would along vote been of be approval having end is CHMP the et in in label transaction hand has having accelerated we've obviously, I type guess can was the knowing this pretty of my but and at day, cetera, guess, Now at a point. -- the important, you the what's the saying expect that. exactly typical all It really

I market. in is think the important is indication dialysis and a dialysis the thing is complicated

really it's one partner and is within mean And so, different understands finding markets European and each one. that -- again opportunity every different who market European is dialysis but those approval, I a of

is for between weighing that think we as partnership. really expertise heavily have that options that and we the weigh we're So we

anticipating we're thing in of that before kind to move product the because to want maximize we to a the want who's very quickly term. of possible it's the to right quickly want we person launch But again, value be long and the end as year. the deliberate pick So the as going we and

Allison Bratzel

helpful. then for That's just Got last it. And me. one

Just venue and maybe you'd quickly. want out of dosing walk three to to on the you us get full seems at? kind data, of FOCUS to trial could presented times that, or through the data data This Thanks. the vadadustat docs importance weekly pretty see can what we expect published that

John Butler

right. that's of Yes, is and important delivered in dialysis providers you -- TDAPA drug vada We that still are home patient. vadadustat. dialysis that be being hemodialysis they if that on compliance. everyone, will for be vadadustat oral give the about dialysis And the dosing you -- for talked providers vadadustat just patient want to about and is times for mean, the week know, providers the dialysis exactly center. simplifies dialysis from the patients And both to a while buying particularly the delivering think an and dialysis taken three for things to is ensure U.S. is once-a-day as is the here basically ensuring way their the know hemodialysis going the and We've in having Europe. But we're for option for important I they're their the quite to the a dominant the approved, beginning that when there. fact in pills the buying dialysis by

And important. to And think as we as quite you to that want so, try times possible. that be is referenced, quickly available we the three dosing weekly have data as

meeting. course, is know be generally of And I there So data ASN a that's manuscript will at we on. present worked being will the meeting the that

but certainly data be we So, would will yet, don't whether the that be there know my expectation. presented

Allison Bratzel

Got you. Okay. it. Thank

John Butler

Thanks, Ali.

Operator

moment Thank please question. you. for One next our

Next question Ed will H.C. of come Wainwright. from Arce

Your line is open.

Thomas Yip

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

process would FDRR you XX another what be the needed? the if the would internally consider you scenarios? And response question first just be worst to perhaps Just within case the FBRR as round to open expected alluded regarding file best and to wondering and of you days,

John Butler

thanks So, Thomas, for the question.

of So, in outcomes the what the described we've are past potential for process. kind the

I hold. I path denied with is the to appeal think that's our in -- vadadustat case a the for. hoping we're would referred probably those forward one very suppose Obviously, back that U.S. the there division. the is much not for That that be and worst scenario be wouldn't outcome. we're again,

The is clearest approval, process. outcome, right? that appeal positive an this is an granted. outcome then appeal the It's isn't Remember,

leads review if they likelihood that division appeal, product six -- two a then has make the success either is the granted, depending or With your submission, approved and a NDA X to So, again and is we it Type to then of the an appeal the whether on mean high. granted approval. I refile extraordinarily the or months, X

be, you very an you Stein that's is denied else the we -- approval. giving some is give more -- "This it's other program, approval, an grant. we've you -- he So as path appeal he talked we've approval." data, a before something forward FDR clear unlikely. third clinical right? probably REM's else and says, other The good an or path an will learned holding a Dr. something option And appeal think and maybe that to our something short identified And FDA these it's a common is an as that's something adcom path perspective, And for forward that something processes. almost to then you forward. giving you Maybe an from get would puts allows that's of outcome as have analysis from as that's but that

Thomas Yip

the on running Switching market Perhaps Thank the to the release Got possibilities it. exclusivity from press scenarios. question Thank some Auryxia, for one it. what you much all XXXX, to beyond appreciate that so in you. are can of Really that's March anticipated mentioned discuss? going, gears us. you you keep loss

John Butler

you. it's Thank a No, Yeah. question. great

period bundle Right add the used patients. that So hyperphosphatemia the part all remember in of bundle in to dialysis Auryxia right now, dialysis, treat oral to to is as binders, is aren't now, going oral is where is phosphate products CMS what expectation expecting they they've their the already these now have said products, payment. to the to last because bundled January XXXX. X, what of And don't in have right rule to the that data they're TDAPA a for know add to

if dialysis a the the collects Part product, per that Part session TDAPA data to CMS utilization that dollars the use calcimimetic be all of ago bundled an a B period few years a at the of then the they they'll and So you end period, they make on went payment. example, for drug of go adding the as being determination product, D -- Amgen they to TDAPA their from a and you drug, the through

utilization so at them each. binders, the do, looking what we the different of to expect And that's

about dialysis providers' So when treat think a patients you this great very perspective, for incentive there's to, -- from effectively. a,

at have on focus the feel Because hyperphosphatemia, added, the branded really use treatment change. on frankly, So products go value it doesn't focus that's look that of the they payment in that's that added. and of again. CMS the order to that and doesn't to back once within maximize of ability payment

real products. XXXX, Auryxia defined this them to those utilize CMS the and for utilize in there's So, so products point for that's like TDAPA at and and branded that's period years two time, been motivation a XXXX by

their have and work utilizing with the protocols, providers we'll cetera, they're them et with on that the dialysis product. contract so directly to So,

to situation So, generics that lose it's unlike and think simply a come you opportunity there's exclusivity more the where in dominate we market, there.

they generic example, to a Now, didn't phosphate if bring to to to be manufacturers where a as look the is even the of amount interest of Renagel/Renvela at wasn't product we even dynamics the have product get nature an these significant such TDAPA, generic sevelamer, though the that really if patents, situation -- the binders, has that we of their market. you to delivered from lost given dynamics there patient

on It cash the a company. the still. flow declining will will TDAPA either tail revenue significant of be stream through be a very very, to And long if one positive they there So need that through or very investments, something we revenue like normal sevelamer. is had sales opportunity kind for see clear, very that little but significant marketing so for and course,

Thomas Yip

questions to again response. makes That FDRR for you looking forward really and Thank taking our the Understood. sense.

John Butler

Thomas. Thanks, we. are As

Operator

portion now Q&A conference for to would Thank back remarks. you. John turn to will closing end the the the I of This conference. like Butler

John Butler

Chris, Thanks, morning. for again joining us and all thank this you

hard cash that global Europe. receiving structure to we've year company since process revenue reflect us of exit completely in It's date, filing not negotiated to to and vadadustat FDA. made on through allowing We've continued brought the European most drive hand. the in progress to Auryxia, our be We've on significant the plus we've led cash with worked And the the million importantly, FDRR rights. past the run we the over over the CRL. the approved an And secured and to took on Otsuka with We've Auryxia company. changed cost $XX

be may milestones look really those more discussing near in the next the to even you in months, with We have what forward I important ahead and future.

great week. Thanks, Have a everyone.

Operator

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

have pleasant and a day. disconnect, now may You

Akebia Therapeutics (AKBA) 8 May 232023 Q1 Earnings call transcript