- Earnings call transcript Q2 2022

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Operator

Hello, and welcome to the Akebia Second Quarter 2022 Financial Results. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Mercedes Carrasco

Thank you, and welcome to Akebia's Second Quarter 2022 Financial Results and Business Update Conference Call. Investors press our issued and second is on a August today, that that website. available detailing our X, quarter our note release earlier was Thursday, release Please of section financial results,

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

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

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

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

John Butler

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

has with team notable our the reshape make spent align Our quarter refined to and progress to working Akebia. strategic focus

from CRL vadadustat outlined pillars Akebia for for wake FDA. we the strategic in the you May, unexpected know, As all in the of the

and from identify to management Akebia company enable with cash We the are first, revenue ongoing operations. with opportunities to working to cash objective the Auryxia resources cash drive manage and existing

invest EMA and for growth well evaluate vadadustat a launch strategic assets partners globally. European thoughtfully approval. our in selling path approval new support and our pipeline partner This internal includes other and U.S. the of third, for assess potential opportunities. approval And Second, as potential as through seeking

the XX% the We Now in Auryxia dialysis has revenue delivered revenue over million commercial first revenue let's to million. XXXX. year Auryxia and raising We've a XXXX reporting X% on team are Despite for critical increase Today, increased product. over is Auryxia growth believe same existing begin increased to progress centers, and the our guidance quarter revenue our for the we of both growth our success our forward. quarter. $X with last this $XXX bottom $XXX quarter range moving guidance challenges top again the by of end million, net the Auryxia, commercial

equally how talk growth, that prioritizing savings In we working taken that significant I'm in that realized our towards processes and impressed through value. drive addition initiatives cost structure. has specific Dave steps will revenue with responded team our business most critical to management we've efficiently pleased we've QX. will to the and and cost reducing believe We're challenge.

of pillar, shifting Now globally. vadadustat our second to advancement

Middle under East proceeding continue to regained United the disease. Otsuka with in for Kingdom, patients potential in or Australia, early is anemia vadadustat of and the and From closely Authorization worked a successfully due rights from believe have kidney Russia, next To oral X we're the review States, the of the the for chronic other day Canada, in Marketing China, with with responsibility timeline pleased Vadadustat the We to the EMA. treatment vadadustat by We're Europe, the Switzerland is note, potential under the as to territories. assume to former currently United certain review vadadustat the an MAA, partner to initial our full The on very positioned Consortium. Access approval through MAA. we process, also on Application, well Australia is expected EMA and year. review

could potential approval disease. chronic by bring review anemia excited to the about these Our as markets to as impacted the Akebia and markets the vadadustat these kidney in team of processes due well are we're through value patients is in to working who of

executing from path constructive with the process. so do the end, for was the Europe. we we approval review the any will a dialogue. not be we for received process team the we In this that identifying end discussing with conference begun We've a it details agency, step our the from would a for we've potential not While a vadadustat. to felt time. meeting last without partner regulatory To not determine vadadustat a process, in of completed We is We yet the quarter, partner. first believe minutes that the engage at in meeting, would Europe the FDA for we commercialize U.S., noted

our Now investigator-sponsored and data UT clinical pillar. the study in and Phase from hypoxemia. Earlier extremely subjects on COVID-XX II we Health treatment Houston for vadadustat shared of a leadership. to pleased with their evaluating ARDS third with them and prevention study for today, thank the We're ran

patients the study the as families. participated well who their as We also to in thank want

as impact not for addition did plan, vadadustat we important we about vadadustat to be and full To the study, analyzing we're condition spend the design pipeline. development our very approved excited meet ARDS plan our and in potential potential to to While FDA. a data broadly, also few might intervention. has for consult with believe endpoint vadadustat an speak ARDS experts to the today, the treatment additional options primary more and a still the set that data time believe ultimately the But therapeutic

to over full be valuable U.S. even details more to more let this rights that, Europe. course, and vadadustat Of resecured now to Steve the pass And with the in study. we've provide that could on me it

Steve Burke

we expert we injury stabilizing Houston, with with extensively lung acute XXXX, could UT Dr. injury Eltzschig, prolyhydroxylase Dr. like patients Eltzschig models Anesthesiology published of stabilization. at That injury of lung contacted study was Ben requirement and FDA. study the X believe scores Medicine, in with X committed Phase after or proportion the conversely X to injury. had II HIF Institute ECMO or Emergency death. randomized Head the with the or measures lessens IND animal a support vadadustat of National primary of endpoint. HIF high-flow Holger VSAT NIAID-OS it] In the lessen or assembled Houston in or stabilizing injury, noninvasive an and and Health is extensive as inhibitors placebo-controlled including inhibiting vadadustat decision invasive [in worsens conducted mechanical by models ventilation of X severity lung out shared being the [indiscernible], requiring Infectious lung the Head ventilation lung scale The consultation on an XX, of under Disease defined hospitals the a was is devices. on patients Devon made team Allergy across HIF who trial day team and and and with COVID-XX. day oxygen of knocking as severity thinking day investigator the HIF In of X, John. XX who's acute double-blind Thanks, at ordinal This trial. for is

X.XX press at X XX% the relative XX.X% to risk release, X, placebo. superiority was X greater proportion X.XX of proportion our a X in with risk X and XX, prespecified In vadadustat day analysis subjects vadadustat day meet probability score of with means or for for vadadustat to or X, that outlined and placebo. of with to of trial the was probability a superior were placebo superior than XX.X% vadadustat its versus a threshold that XX% a for of at XX% placebo This the score versus of were for of As failed subjects that with primary probability. X, a XX.X% XX.X% relative

this And due potential Houston are program. we to hand has to of X, of ARDS at for to However, These publish benefit encouraging, overview. in more a for steps a We vadadustat Dave exciting XX% in financial ARDS mechanisms I'll or day data, particularly setting. the the to of believe the demonstrating determine XX% the since smaller of insults the proportion to group care the the and UT We're score broadly probability X prevent and probability subjects with closely of further exploring over data COVID-XX. to had a underlying not next Health benefit X specific XX now will are diverse day X. are this in working acute and interested vadadustat at benefit for it work vadadustat worsening

David Spellman

everyone. Thank backbone Auryxia. of and long-term The you, our good afternoon, plan growth of Steve, continued is the

demonstrated this that our again focused net we product quarter team As increasing Auryxia. John from are on mentioned, revenue

seen our restructuring, across year. Our is this even full be We with we major of first expense operating management operating impact can team. versus the continue believe a before this It decreased of the our in savings decrease almost focus our cost to realize areas will significant significantly quarter we of all expenses expenses which business. quarter the a

which quarter quarter specific $XX million will over of pipeline quarters. over now use and those terminal expense I over operating compared for agreements. settlement $XX save we covered, bases our for expense Subsequent portion we of our XX% we into the million measured Total of allocations some and with will our reinvest million cash quarter, million proceeded down us turn paid debt $XXX.X results with the months our funds termination collaboration selected the from That of quarter to former the second We of to $XX.X the following beginning of in grow revenues expect and in our interest come XXXX. a was to Otsuka, loan. expected partner, will coming the XXXX revenue. funds for Pharmakon, the pipeline. way was which our the to financial important our revenue As to second will, a collected prioritization pay of the ended, plan

payment net John net under of in for revenue our was to second $XX.X Otsuka for where XXXX $XX the collaboration mentioned, of quarter XXXX. increase growth increase. of million with Compared revenue $XX.X XXXX, report the the QX product of The XX.X% a and pleased revenue revenue million terms in million XXXX, the and compared was we're $XX Akebia Auryxia million termination revenue second to As increased X.X%. QX million that other compared paid License, QX Auryxia by for for XXXX July settlement for reflects to product to $XX quarter agreement.

to company to and certain noncash consideration clinical addition, million to $XX.X revenue related recognized complete In the Otsuka's previously million $X.X related obligations deferred activities. of

reduction during million were clinical to to result quarter and The QX of compared lower the for primarily in quarter charge commitments decrease and sold million headcount-related $XX.X million Cost compared The expenses a XXXX. The primarily was liability the to XXXX. expenses. $XX.X of due quarter to administrative Regarding force the of XXXX of $XX.X in $XX.X decreased to decreased the Selling, of the the were for increase XXXX QX was second to costs due for related decrease million general of XXXX. for of costs force related to second previously primarily headcount related and contractual expense second launch and announced workforce was termination compared decrease to purchase studies. second due of compared as $XX.X in primarily quarter result preparations. benefits. development charge, $XX.X benefits onetime to million quarter prior million to of In a expenses and was lower connection discontinuing the as with the related $XX.X second reductions, XXXX. restructuring termination excess our a Research million this costs quarter $XX the of marketing an includes reduction year a to for million XXXX goods noncash for

million not reflect ended month. include $XX made to second $XXX.X Regarding Otsuka does Akebia's that which repayment position, was approximately and cash cash collected does July we our $XX not quarter the the from million last approximate with in Pharmakon million,

years. we grow Given cost will to continue reduction company's current we the our if for we've revenues believe progress we resources cash the believe continue position, plan. as our and successful our summarize, operating implementing next as from the significant, several we operations are well our to plan in is existing measures, and implement cash made cash fund Auryxia To

Auryxia revenues or through As would may our partnering value team prepares royalties articulated realize plan upside the we to revenues an exciting the continue open the to in to sharing We potential be European to other opportunities today. for the and approval, have we a more look forward grow build to several With that, line on. come. Operator? questions. for quarters we'll potential

Operator

[Operator first Sandler. comes from Bratzel Piper Allison question Instructions] from Your

Allison Bratzel

from quarter. X me. And the guess questions this progress congrats on all I

is The Auryxia. on first one

will between now reduction Just just based we about path a cash year? to at us genericization LOE? phosphate expense help per mentioned beyond guess, binder Or then similar be beyond understand improved trends, its and this measures, your the You should market. pill of seeing to LOE, of could the I positivity price its on And if stabilization the guess, even just you're much Auryxia's market you flow had of pace goes expect tailwind trends Sevelamer. and thinking I that future a

that a just volume second minutes. on could So and is how my Could outcome FDA sense for and question, then the you XXXX the vadadustat. Is call? of be be update waiting growth for clarify we on So just we're an interactions it next communicated? outcome the of your your anticipated driver meeting get thereafter? I Or for something that can look before earnings. QX that on will QX your meeting on should steps we know

John Butler

much questions. thanks your Alli, for very

to going But FDA. handle going with that's give second And think I us I've Again, a well. let I If first, we on we'll we're interactions. we're in we past, not them. -- I'll start know. as the give not this miss FDA got anything, the on way think play-by-play the just to the one said

something we'll course, appropriate. updates moves the of any we'll give if forward from as interaction, process as Of comes that material disclose as kind appropriate. Otherwise,

So Auryxia. on

So the driven you as think contracting dialysis contract, particularly paying over staffing is by growth dealing population. at still on QX. couple in think some about centers, the see price. has versus about off we've but market of as dialysis. the pointed dialysis quarters, a really price given phosphate to Auryxia That I driven in continued rebound, is that the is that which the But strategy more talked the with with to is by happy we're COVID, very last to we've Keep which strategy expecting the guess, for we've challenges you contributing then Again, also growth that seeing the side. revenue about as now, of the are of which much past, largely issues the the impacting in I talked we're QX binder out,

see we've So how year, market we expect to to we'll and guided binder see this develop. continue as continues that the

that think of dramatic get path think, not product the volume we putting think there's volume our not about there. that's opportunity that we're about grow on for kind As -- side. again, pipeline, a we profitability, unrealistic the out, to -- within not started working continue decreasing job really delivering And room on development do to really I team revenue But this those, is in know, the and I today. expectation really still the to did expenses. we don't anything think cash the I to continuing driven of dynamics the thinking But we're to in increases to by We quarter operating guidance. do look And you that what you deliver the guidance really Dave about to progress. at mean, And pointed caution, expenses, profitability that's on our encourage line our market, path. continued continue some how level binder on given that. to top where we're reinvestment and the we're we all of continuing thoughtful going that phenomenal our the ultimately, is us those path control of to certainly the of on first to to is talked there Dave, just deliver line. that's have think we that? looking add is continued down think But the combine when top I targets, to But allows I to

David Spellman

it. I No, that -- on you think hit

John Butler

the as all a final which beyond. the did talked XXXX phosphate LOE, think proposed within the And that develops meaningful, clarify given couple the looking Auryxia do binders market. how a for weeks that And for there's their about us But how nature is et the at at in LOE. creates we've that beyond of as of talked you we've opportunity the cetera. look rule do but -- Auryxia inclusion the for we see binder opportunities we're of about When CMS we'll comp, opportunities as ago, But even bundle, rule, LOE think we believe but before, Alli, Sevelamer and there's we well.

Operator

like the further are back your time. turn [Operator CEO, this remarks. for There over any would conference Instructions] Butler, at John I closing to questions no to

John Butler

and thanks, for us Harmony, today. joining everyone, Thanks,

quick believe decisions our new quarter align company progress the a revenue appreciative with about to Our forward was I be work pillars. extremely second reduce and to That costs. value. team to strategic has marked work critical and deliver move operating and we Again, thoughtful I'm by the our what make of how reset done drive to impactful and as is

excited much especially approval in look our Thank update including Europe, That's commitment to in potential continuing we ahead, for quarters to remains. changed you to While forward has in I'm the and patients you. future. opportunities since about the why vadadustat April, the

Operator

The today's concluded. Thank conference for presentation. attending you you. has now Thank

may disconnect. You now

Akebia Therapeutics (AKBA) 6 Aug 222022 Q2 Earnings call transcript