- Earnings call transcript Q3 2022

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Operator

Good day and thank you for standing by. Welcome to the Akebia's Third Quarter 2022 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. to Mercedes conference Corporate Carrasco, like first to Communications. now today, speaker Senior would hand over the your I Director of Please go ahead.

Mercedes Carrasco

XXXX website. detailing a is Investors press you, Akebia's was that issued updates Thank release welcome Thursday, release quarter call. financial November section financial today, quarter and X, conference that you. the business third results of available note Thank Please on earlier our and our and third to results

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

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

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

in these section and the results on filed SEC. X, as included Additional, well we with quarterly Management information and release is and issued in the recent describing the annual that our Factors most Discussion November financial as reports risks press of Risk Analysis this or on With I'd required do call Butler. John by like undertake introduce we only to original date to statements statements. of except this law, forward-looking The not obligation our CEO, any as revise the these call, update and speak to that,

John Butler

work Since thank Thanks, on joining to update, aligns last our afternoon. team three all our Mercedes, been strategic this you focused that and us pillars. Akebia's has laser for

Auryxia third of we revenue, managing First, again are revenue in we're costs. increase quarter, over quarter pleased an And working to the to this for report XXXX. while drive Auryxia net

regulatory processes a vadadustat anemia as to treatment color globally. on vadadustat Second, we for support continue I'll CKD. review due for the provide to more

work we've few we say the about to our is and acute explore drive our we to with today. to words have respect won't invest distress to it the a progress based next term science. I'll that build pipeline, recognize in unless made pipeline third pipeline. just syndrome. value area treatment vadadustat a steps Our as today, the But pertains HIF stability opportunity financial thoughtfully particularly invest in to continuing to as in continue of for that pleased our our with I'm long respiratory in We that pillar

share results, Now QX. Dave details in two there headlines will the specific more about financial important but are

as to continue driven noted, see pill. is year-over-year First, net I we in price in increase product revenue, an increase a Auryxia net per which previously by

bring operating team strategic and a revenue Second, decisions positions well our to down continuing year quarter. reported compared QX about to Akebia costs. expenses managing to decrease the work in We operating as has Auryxia to expenses future. Driving as and is versus prior our make 'XX,

clearly most is vadadustat. we value, As catalysts add to about our immediate potential think

As vadadustat Consortium. Access Kingdom, last submitted MAA of Akebia. and rights we the the quarter, for certain to excited potential October Australia, Otsuka from We're European Canada, vadadustat in through Russia, approval States, in other and the the the to reported markets Middle the Australia we Akebia in application responsibility and assumed could last United territories. full United or marketing to Agency about authorization the China, Medicines the regained Europe, these East Switzerland bring of value

next Now impacted to approval quarter. potential for disease. anemia on vadadustat due the chronic kidney patients eager targeting timeline by based typical a bring a we're MAA, by to an review to We're of end

without vadadustat While in not expect leading our Europe to the commercialize we is process, partner. regulatory a do team

the favorable CKD of balance and and FDA on patients FDRR to formal of XXXX. that dispute with vadadustat to resolution in believe benefits the for on CRL anemia a S. an the continue the dialysis. issuance favorable Our for submitted process delivered for of to In appeal identifying for risks always referred a as focuses We've the Europe is for due we a to in recently unmet risks the March treatment well U. partner underway. the of of believed of The request, FDRR benefits due need. vadadustat CKD anemia the adult in balance treatment vadadustat and to as a

Now drug of publicly committee clinicians their share late related as month to discuss moreover, often advisory And meeting. during and continue cardiovascular need to patients again the the burden last unmet disease. the we heard experiences a renal

the injuries. It Health have access with for and quarter, the FDRR active a was end in that with on And and Recall, continue the to condition conference thrombosis potential we for other typical receive of be dialysis drug the its Based for completed on from studies. potential related rate end last benefits that liver by data meantime, can issues We're the a UT according continued narrowed from conference, vadadustat team FDA will share conducted patient for on and with vascular study population. to the and clinical clarity of you. we'll protocol driven explore this the XX% dispute. the review our a incorporating refine the our to Phase opportunities the that ARDS in in broad placebo Akebia ARDS. time, we value. significant we bring expects long design. beneficial towards approval vadadustat end both on We design were path important last concerns encouraged the the compared year. in FDA mortality vadadustat that the Phase a of reported by to and a to therapeutic the we of of over by Houston vadadustat sponsored believe closely vadadustat of the be the population. data submission product of on the ARDS which the study working the of and FDA a expressed X serious that prevention term course, in for of the review FDRR the outcome process, discussions could ARDS update CRL response the reported feedback As into events to starting induced to is rate And in and and for of COVID-XX multiple intervention and for the Again, US. the subjects planning as thromboembolic we treatment by investigator study a to comparator In for Since controlled treatment options FDRR X risk risks evaluating the with adjudicated focuses to approved ARDS related a timing for light safety few hypoxemia. we've on follow-on

well ongoing stability To our The committed we I've that value financial as I'd complement Auryxia our team value vadadustat, long future. in our And more three said, like details thoughtfully As financial They're as for near as working provide critical the create turn term through to invest and pillars for with to is picture. is on will their term Akebia. our that, I'll our opportunities end, to that drive deliver team to resilience. Dave pipeline. to

David Spellman

you, and Thank everyone. good John, afternoon,

product cash sheet. a cash the concerted clear, company effort maximize revenue, expenses management balance net objectives reduce ongoing our and resources existing remain strengthen operations. continued operating and from Our manage We've with to cash

into to financials, listing I dive Before I wanted NASDAQ status. address our the

of listing. various and to term While updates in to million the our $XX.X available. applied to capital stock options John net million in $XX Auryxia the value, we reported million usual, third NASDAQ revenue, of mentioned our through provide of a NASDAQ XXXX, $XX.X to Total to manage million that are compared will third $XX.X third the list add increase. quarter quarter we market the quarter when working product common XXXX. revenue the ways with the to third We've long in to XX.X% we we compared identify continue of Beginning transfer material XXXX of quarter XXXX was as in

top commercial growth. strategy Auryxia Our continues deliver to payer line

in in market market. X% start biggest on distribution is lower their binder XXXX. Further, earnings year that the challenging on QX you now, product right up, calls XXXX, that nearly by contraction continued I'll product providers the country's the of point, second expand challenges since community. the market challenge year and binder is including has operations. quarter the very likely declined from with While heard to net as in dialysis the of still our report of to X.X% we at impact driven of phosphate a the impact COVID inventories COVID, dialysis a did have QX XX% To on net well staffing XXXX from everyone is note real as the the a from real overall partners, dialysis having decrease COVID revenue that revenue

or unsure revenues because continue grow contracted to even strategies we but some challenges. term long But forecast factored these headwinds previously binder have We again. into believe market payer will market recover and when LOE, of are the this product net have through will grow related with still again, we real and the executed, to our begin

million in of purchase for and As for increase in to such, between for XXXX. Otsuka million the to the XXXX of quarter third reoccur. to a $XX during XXXX, $XX.X in US of compared and related a third was in The non-cash quarter a XXXX primarily one-time compared excess to third third increase million liability the second million liability for was commitments termination position quarter the of period international the sold to the to the primarily from The excess and guidance compared goods quarter benefit remain revenue third in decrease the Auryxia collaboration in purchase XXXX, of non-cash the not of we other of and related which of the related XXXX which License affirm of year a million million. product was to commitments decrease the quarter in net did third agreements $XXX $XX.X the our $XXX $X.X due a prior collaboration was event. of XXXX. quarter to Cost of $X reduction to quarter in revenue charge an the was XXXX million Akebia a $XX.X

Auryxia committed driving functional particularly worked to expenses. our SG&A areas revenue, spending, have are of cross the we to as reduce in teams Just

in costs legal general XXXX. million costs. in Inclusive to plan in in cash and was year decreased XX, equivalents the as repayment, lower the in administrative the decrease outstanding reported million Last trial of clinical of the for related Pharmakon as to of approximately million quarter decreased our be debt decrease compared on fund the prior to should least $XX.X Our $XX.X delivering plus primarily million. quarter The headcount to that resources due cash compared as third reduction you operating at from and line. year compared Auryxia our $XXX.X the headcount quarter related quarter. $XX.X prior costs XXXX compared well costs to trend next Selling, quarter third $XX.X which were XXXX see force, team is sales. interest flows a end we data company hand the current future million principal real have of expenses proposals, were of million of months. sufficient committed September operating with one were any XXXX. cash the is obtain in our the the time debt expenses reduction and and third with Pharmakon, expense cash continue. $XX running vanity in period XXXX the downward We not development first on we at the we do In believe to to due was primarily the Research will with third is lower decreased to XX The event quarter, and force, restructured agreement Cash expenses in period marketing of expenses. the our savings result as

costs assumptions planned measures the operating cost of supply expenses. and partners with and amendment of growth overhead reduction certain resulting Our contractual of plan to operating reduction agreements includes and revenue the pertaining the from avoidance

further from line questions. extend our factored other to not the potential partnerships for upside regulatory With vadadustat Such to related and Operator? additional generate or vadadustat our of we'll open value cash catalysts We ability that, runway. have transactions. through approval in could the potential

Operator

Allison this Braxton Thank [Operator question session. At you. excuse we PSV comes will Instructions] Our line -- of me, conduct from from time, question-and-answer from a first the PSV.

me. Forgive

open. line Your is

Allison Bratzel

Hi, for and the my guys. update questions. taking Good afternoon. for Thanks

Auryxia is first the the business. So on

that asset? us bundle? the evolving Now and that reaching on flow LOE added the commercial will opportunity vadadustat. it kind kind a tail? help of if also have gives then of do to see timing you the that, you post significant a you understand related just through revenue can follow-up cash confidence And the for just And are binders have you're to that how us what restructuring, for levers positivity the And remind I

John Butler

Great.

questions. thanks much for so the Ali, Okay.

So it. big for rebounded. been in surprising calls population. look mentioned Auryxia, you again, of waiting -- -- binder and just dialysis And really we're dialysis COVID, the been the of that's market hasn't to out Dave has The all I've the kind of thing listen we're you kind right? been not -- providers And

at [US you see for this look data unbelievable mortality XX% patients. you If and ARDS] dialysis (ph) rate

the so, dealing And on basis. community regular dialysis with a is still COVID

that's mean, So the every the binder since grown here. has quarter. in whenever business I've wildcard I or XXXX market the been

to been But for strategy it to that So sure us a not we've the volume we with a us is us we see growth continue our allow will as that allowed backdrop have think in comes allowed to to adjust Dave LOE. has continue see growth even when that's sort back. even and backdrop contracting market forward more that got and we're driver to us of key and through able flat as to moving referenced, that,

not increases perspective the just still we're rebound. in more being -- cautious because think about we we we don't revenue going from when the we're put not volume product, the strategy so, drive can that of to you because we're about do really as a we've Yet -- can place. growing what know market is And

where using opportunity volumes post a us the that continued there manufacturers of post an for the exclusivity, really LOE, loss comp but to So growth. there's kind opportunity Sevelamer was volume an of there's market, beyond kinds a years generic as of of believe because certainly of in confidence. The perfect for exclusivity, the gives just we number have that that produce

Now slope, of revenue it, way but revenue, more about it a we will slope people always revenue said of is you talk after be think over LOE and a the this declining clips time. declining

is to of CMS again at period you Now bundle. rule referenced the the two adding a binders put the of be will the going the final there TDAPA that other wildcard out the least binders bundle. confirming for years into a

January would is ‘XX. that start March ‘XX, LOE of recall So of in and

who directly to are goods have the of free you we would and patients. contract So volume on opportunity now. more be all part patients They paying have

significant out us of think we seeing over next So how that's there exclusivity. to are years. opportunity still a couple for opportunities, beyond loss going number of clearly of the But play just it's a

think that all. -- there Was that in I I was covered. anything else there? them think I got

David Spellman

to I said, she Alexia. about our from drive flow Ali think ability cash as was talking

an said, it I And the think allocation can contracting just a markets that's big actually as of and what operating and more John continued Ali, focused really on is to really, managed revenue. part continue is the the it perspective, again, strategy drive from investment discipline of time. team expense an

last we're spend we over are spend the so, of the couple aware we so the reduced of lifecycle, has focus the in as And where years.

John Butler

so. to And do we'll continue

Allison Bratzel

focus you look in a now minutes based have submitted today. you It Excellent. guess, just a you FDA what population. confidence Thanks. this second are described appeal year the response have resolution very what a for and successful we have process walk dispute to after expand can what could that? at agency could there year Could my had in you through kind expect then through vadadustat. any narrow end? that from a on approval I of lead that the gives of US Like then, just process that end examples dialysis to comes as hand of on you on guess receive I you the meeting updates the request. question the FDRR that then milestones And drugs the or next? the Thanks. seem analog of also and from that does is to And cadence outcome have the us you an

John Butler

that before. a I'm folks so we formal Yes, first well. from have we great going thanks through as And time But who's the used myself, product I to support where are the we I'm think unique and kind to that been through dealing go the many CRL we're think learning the We things said is clearly that the have it beginning I demonstrates that's each for safely. dispute with specific the from data can dialysis very of say the you're focused. this times is and that as dispute resolution question. be

around that able I in and think we to the be expressed concerns labeled helpful. can being been that in have the conversation process this will be CRL think have

resolution on help dispute for now potential I As and have review the and focused end thromboembolic dialysis it's when by injury. well the formal you the two liver mentioned, narrow of I said, as access, induced conference issues for driven focus events that the DILI, those drug thrombosis really

FDRR. very, focused And So about the again, strongly very data. it's we a feel

the looking the we're we And FDA so certainly won't where but going process. predict down, forward will to through come

As the have -- we kind we with we constant the don't NDA contact said agency. during process, of

kind So play of we give by play. don't

have formal but by which timing So the when think to expect formally the it's into holidays, January, might of the by the course, of again, I the first a end you'll we a be from the on bit hear from end calendar of hear so perspective we the of leak agency, year. based should the response that year,

Allison Bratzel

you. Thank it. Got

John Butler

Ali. Thanks

David Spellman

Thanks Ali.

Operator

you. Thank

Our from from of next question is line Ed the Arce HCW.

open. Your line is

Thomas Yip

up questions. This Ed. of the question is following of on the Perhaps Yip first process. for Thomas for Thank everyone. FDRR couple asking you a questions Hello, just kind

would or mentioned expected scheduled XXXX. we in time? that you response written be year at Would that response be should response You Can by clarify of the type expect? end future what meeting a the press is a release it

John Butler

potentially the to get during communication response won't written that it to you formal of other expect less formal there a lots of CRL, a a process, formal dispute response, that not get be do think. resolution a you like or get we we written I But once lots Yes, response be document.

So that's end. year what by expect we the

Thomas Yip

it. thoughts or benefit will on What UT the forward Thank partnered vadadustat some And sticking study. next also, Health? be specifically Got in ARDS, you. key program [indiscernible] going this And the and saw initial perhaps we with other endpoints? are your endpoint study, to primary

John Butler

working of be. So we endpoints are study what will the on the still next

may endpoints that's very and I -- the the use COVID-XX that was going used but a we study scale forward, think was endpoint be still under discussion. that in solid what the [indiscernible] well

important population, elastic it and in It was that population in and great younger at we a treatment in you patient performed patient effect really much COVID had like the see a I look in driven a is study can us. things they ARDS population. we for think be will what's performed study through. by that mortality When higher broader The sepsis, executed population. UT ARDS you a population this they study, that the and come more rate that think you broader scale that see potentially pneumonia great

still to probably on go where that's think direction. that, that we in be determined, we're but working So it'll

not study working but that's first look with but the UT trial. to at say them the job I product with formally study, UT Health, we decided did certainly is great this next So would looking with on been such forward performing partnered the we're Health, a in They either. wouldn't

Thomas Yip

taking clarification. the questions. again Thank thank you for you Okay. for much And so the

the FDRR. Looking updates on to forward

John Butler

Thomas. Thanks,

Operator

back would it I turn like Thank now you. remarks. for John to to closing

John Butler

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

financial efforts from said we've in work and standpoint for to the I a our since lot As believe April, in Akebia. the has thoughtful changed and of deliberate for our a I past, been stabilize in plan to future Akebia but

initiatives to to have As updates processes we could value anticipate we'll other the as can. we add look Thanks company. everyone. of close clarity enable regulatory that We us more the to potentially term and we forward near XXXX, long on providing that

Operator

This Thank program. today's you does for conference. the participation in conclude

now disconnect. may You

Akebia Therapeutics (AKBA) 3 Nov 222022 Q3 Earnings call transcript