AKBA - Earnings call transcript Q2 2019 | Akebia Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Akebia Therapeutics Second Fiscal Year 2019 Financial Results and Business Highlights Conference Call.

As a reminder, this call is being recorded. Later we will conduct the question-and-answer session and instructions will follow at that time. [Operator Instructions]

I would now like to introduce your host for today's conference, Kristen Sheppard.

Kristen Sheppard

morning. good and you Thank My name Akebia. Investor at President Sheppard, Vice of Relations Kristen Thank Akebia's to financial us you joining for discuss our business results recent second highlights. and XXXX quarter

the afternoon and also containing financial the The relations our is was press this results available release for earlier issued second investor Company’s website. on quarter

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

Officer. John are Jason Butler, President Executive Chief and Financial call and Amello, Officer; Chief our Joining

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

factors Management's date the described Factors on forward-looking revise our or do not these Risk this reports undertake annual of sections The speak is Discussion of call any statements. Analysis recently with only the and obligation these original quarterly update most and to statements of any of we call filed this financial in Additional and information SEC. and the regarding as

With to our John. call that, to over would John Butler. I the CEO, like turn

John Butler

everyone. And to the morning this headline continues morning. initiatives. Good we Kristen. be great continue believe to execution. story we year, you, Thank the first a against progress share strategic our have this you of with We Throughout half make solid good to

Auryxia strength with the XX% Auryxia XXXX. Auryxia in of versus for IP. in year-over-year the first growth million second XX% since reached The and the $XX delivered We filer revenue that teams of commercial settlement growth highest quarter. the The quarter our launch, reinforces ANDA quarter

announcements was park regulatory expected team significant an to of filed vadadustat, for is by knock in Tanabe Mitsubishi the collaboration which approval the submission MTPC first of in And beyond. beginning with exciting just We of the a and to of out both continue This is this vadadustat, submission marketing with companies. lineup Japan. our respect clinical milestone or it JNDA for believe the XXXX

ahead we deliver I of our to believe While is value with tremendous and stakeholders. disease, to better still to much work our there all opportunities of mission kidney the significant lives people advance us. living have

very We as strategy it to the is mission been continues purposeful to on in have achieve the coming benefits this team light our our to to our developing great work systematically and of priorities. execute see

Phase more endogenous vadadustat. with I will that investigational oral disease physiologic start CKD. a to to in is designed for chronic for production Vadadustat our to adult level stimulate or kidney III with our program progress due patients HIF-PHI clinical is anemia

oral JNDA first because but to non-dialysis filings CKD vadadustat, in is the and impressive, submission may also for the patient establish file market. populations HIF-PHI treatment approval major dialysis anemia a for approval is vadadustat both dependent particularly to in it only for the as marketing because not of dependant believe regulatory we of first Our due

MTPC in III Japan pivotal with first we top-line Importantly, the data was by two positive this active-control announced supported studies from quarter. in that Phase together submission

to in dialysis in our III the for MACE. year our dependent for to enrollment of continue April program. to clinical patients. We and top-line due subject Turning nearly INNOVATE global expect treatment completed enrolled next In anemia designed the the filings we QX a studies vadadustat enable global preclinical of of to we Phase approval total regulatory to in XXXX readouts across of two studies data CKD INNOVATE

accepting new be on we I’m we that has studies complete to our longer as announce global PROTECT to strong for at continued dialysis. enrollment in pleased designed treatment shortly and vadadustat enable to patients regulatory to the to the enrollment clinical CKD filings respect not of expect due With anemia patients Patient screening. are no to

to MACE. of data continue top-line mid-XXXX We approval in the readouts to subject expect

in a have and believe for have we clinical, that we vadadustat tremendous are commercial design confidence the regulatory program amount and of success. We well-positioned for

are and an INNOVATE active-control non cardiovascular the For inferiority to and vadadustat designed which an using efficacy current of for for care. PROTECT safety assess darbepoetin ESA injectable standard example, both is alfa

We a believe ultimately this enable MACE across of collection structure readout. data studies will and relevant a straightforward and analysis the clear

of secondary Importantly endpoints heart hospitalization and for areas our and the disease. safety differentiation progression including blood important other of the CKD program non-dialysis and commercially And includes pressure. hence failure on clinically efficacy subject effect kidney incidence to assess thromboembolic TSA, multiple in dependent of events,

at to as EU and of successful they directly first HIF-PHI standard to important care. patient relevant and comparing current care the patients. in we make vadadustat in physicians, these about and patients expect dialysis this that will outcomes markets where data U.S. the non-dialysis payers both believe be data We extremely for be If studies, the decisions its

patients of active-control, think an that this be note our to will designed study stay drug. to during to study I study with non-dialysis on is progress was because it here this in able dialysis population that important

we be to or drug of compare forward. these able dialysis how result, control new-to-dialysis expect vadadustat as do and a the move As either they transitions to patients on to

of very large number paired be especially have the event and patient INNOVATE regulatory this We patients. data that of generally will much also the study across when a for data incident that It in our population of We more care makes analysis year MACE first new-to-dialysis higher. our continuum rate valuable patient from is straightforward. standpoint, particular a as believe dialysis because with is commercial much the in will a interest,

designed key needs was patients same. the another a every advantage are not is that it basic program philosophy believe with of We our

flexibility patients, clinical three with designed for with the potential dosing for dependent our once-daily oral dosing week CKD As for result, program a a times dialysis daily we patients. CKD dependent dosing non-dialysis and

after these and FDA the Lastly, regulators. with extensive we designed dialogue European studies

plan. agreed with And the FDA to also analysis We FDA we and agreed of have components and key prospectively defined margins on the with the our statistical non-inferiority EMA.

Auryxia dependent iron for the oral approved CKD only our deficiency tablet in dependent anemia the iron to IDA. to patients commercial hyperphosphatemia , U.S. both CKD treat Turning and dialysis for patients products non-dialysis

For QX, $XX doing increased near-term is to Auryxia Auryxia XX% great and team on million ratio growth to revenue initiatives. prescriptions job total our increased a $XX,XXX. executing XX% The a

Auryxia see continue within hyperphosphatemia which indication, demand solid to represents product We for our revenue. our we of believe most

weeks quarter Auryxia and half growth In underlying revenue that the across a our demand believe in is highest any growth affirming we market prescription Auryxia the Auryxia fact, the launched, second We demand year. will have of four the the first confidence seen on initiatives, on quarter of the was for is our trajectory. third increased since execution continued drive of

look our A from with more for Auryxia would under forward quarters guidance CMS continuing a excellent for early specific revenue favorable for year, our more to IDA indication few opportunity solid providing outcome work after next of get coverage to belt. the Auryxia upside. represent we We restore

In about long-term looking most impact story I'm CKD. the further lives are of ahead, and with with what to living Auryxia advance people to respect its excited we is growth continuing how

We have current have to indications. always treating beyond believed in that a patients role Auryxia our valuable

the we American believe recent with are encouraged Society published this We in of supports potential. that Journal the Nephrology of data

investigator to merger the it previously, prior care Jeff was lead mentioned this Dr. publication. by Colorado Keryx conducted have the and and funded study an author Block with initiated the of We principal by study, investigator as

hemoglobin, XX citrate Auryxia with associated and trial that standard in care ferritin citrate CKD. TSAT and pages comparative advanced or six effectively XXX in of concluded of standard site, dose single to compared a parameters significant The that FGF improvements in of managed serum with multiple was and care. the In significant authors decreases biochemical ferric and phosphorus, ferric to patients and

citrate. encouraging to statistically dialysis, hospitals lower the was able admissions transplant finding of fewer in patients received progression who hospital in small this The investigator in or that death, was show incidence and days to a those the significantly study, fewer ferric

common related in a serious authors adverse potential. the event adverse warrants for are excited patients about and findings events about No now Auryxia's and we that very further with of most and number to conclusion pilot who really the this advisors, citrate we also data gastrointestinal. with study which occurred are encouraging KOL investigation, exploring These the are ferric related

It policy on same in with time outcomes billion and see the expense priority seeking placing these the treat this vision than to reduce and annually is the the a initiatives, like health kidney chronic American at initiatives aligning while disease. advance $XXX renal new great U.S. stage to more end

believe with both we this value care, payers. creates early, and its improve prescribers Although but Auryxia to not enhance only also patient of environment the opportunities

you know the intensely we As focused value protecting of on Auryxia. have been

of example and we XX, that execution entry to very ANDA this the settlement of is and XXXX.This we have does believe strength Auryxia are property with worth generic We the our noting week, March reinforces the in until outcome. earlier the another pleased well not was allow great par intellectual a quarter announced solid

with Tobacco trade indication approved Riona. Riona, also Torii subsidiary under in collaboration a who second Japan for investing ferric goal adding the are citrate for we the pleased with Japan Lastly, name the and of partner market its

stated Earlier successful reported in treatment They results pivotal III program. in adult for July we the Phase additional expect from of III Riona study indication patients top-line in this also comparative IVA that upon a announced of they Japan. and positive Phase file their to completion they evaluating for

enhancing prospect thrilled and Wrapping potential. Auryxia’s we about the have we feel and today, good of to up is the vadadustat continuing opportunities the advance team with

that, I turn Jason. will with And to over call the

Jason Amello

you, and Thank good John morning.

revenue our looking of our As development product solid efforts. John a significant grow and nicely. continues while progress making discussed components at on the to we quarter commercialization P&L, the delivered When

for reported the XXXX. also during period to over of Auryxia same for QX Net Keryx the to a the merger pre $XX.X revenue XXXX sales product $XX.X as million XXXX. second of this XX.X% And of represents million in quarter increase by XX% increased

with we to an effects about million. XXXX, million the intangible to $XX quarter second for sold our Cost $XX.X bringing non-cash accounting to and Auryxia purchasing associated of the $X.X of of of Keryx amortization inventory that including million for step-up merger the was million cost GAAP total $XX.X the of manufacture goods the of X.X million charge reported had sales

us advance As are continue are continues and strategic your agreements creating of license revenue as we and revenue collaboration value to we for important our program. a highly elements Coloration the reflecting both execute strategy. in know source our to significant financial of be our

million in funded both funding to those $XX.X XXXX and relates with and our of Otsuka Phase of $XX.X of QX has cost the our majority second costs. in collaboration began Otsuka recognize the license of quarter, XXXX development starting Historically Otsuka million quarter which of vadadustat compared agreements. revenue the XX% XX.X% we second periods For of III

was it its Akebia, payment from royalties. revenue submission collaboration probable recorded stone that and $XX commercial mile continued with revenue the JANDA additional form our second quarter to come Also in as in as MTPC MTPC million we would the and future connection considered milestones agreement a progress of attribute July which at With in regulatory also time. in

costs were research million million to The expenses XXXX primarily Moving increase and studies for ongoing $XX.X INNOVATIVE increase and continued for related of enrollment. our advancement activities an attributable the and the clinical to vadadustat, R&D as $XX.X second supporting preclinical in quarter the external to was of and activities second of as to three development quarter compared well XXXX. including expenses PROTECT the regulatory of

revenue, gets our also is by Phase XX% reported impacted are that to III expanding important and I costs collaboration headcount reimbursed support mind consulting to which our expenses were It in our as programs. increases R&D mentioned keep of earlier. by costs R&D as Otsuka, of

of administrative attributable compared commercialization comparable costs $XX.X of quarter and no were general second million was increase pre-merger XXXX. the XXXX. second associated commercialization there second quarter The costs million XXXX, $XX.X with Selling for was the in previous for the to expenses as primarily Auryxia of quarter

for as result of of reported the net Keryx want to non-cash quarter related XXXX $XX.X XXXX. $XX.X that the XXXX application million loss accounting the loss merger charges for to for second for results, earlier. of the mentioned a of the million point Again, out that As includes of impact the million of a quarter with of the to quarter operating net of second second compared a the a I loss net the I of Company foregoing $XX.X purchase

quarter second for to cash the and equivalents million. securities $XXX.X cash of available Turning our we and capital position, ended sale with

fund our with manage development continue efforts. and continue we our operations as Importantly, to partners our together we effectively leverage resources, and advance to

outstanding. collaborators And from expect current research cash We the including next to into funding resources, committed our ended development the quarter operating XX-months shares beyond the our lastly, quarter approximately we million find and with of the XXX.X plan XXXX.

will that, Operator. questions. for With the we open line

Operator

first comes Our instructions] from Morgan. question Thank Eric JP you [Operator Joseph with

open. Your line is now

Eric Joseph

thanks Hey guys for question. the taking

I you elaborate KOLs outcome on are for and on I'm have label studies a regarding your additional from a types comments Auryxia expand a if concentrating the John, opportunities Paper. I the guess, to you we wondering seeking specifically a Just follow-up. But bit later Block’s studies then us. of whether couple claims from are little with PKD and with stage could

John Butler

are study way Eric with has clear thanks very outcome was The at That very world much question. a outcome real this. is thinking more the lot for was FDA we a it really that way exactly the designed, interest you the and study when studies very Dr. Block results. look about kind of in straightforward

think label that you for of similar about about on data. and So, kind kind the and impact even what of expanding way physicians design actually that to course, see the ultimately that having of a we basis, we taking have can when expand ongoing demonstrates, Auryxia just confidence been discussing a very that product before the think got think and the you day-to-day study is

So, and we is this have, this just very exciting been much to growth that too just not is strategy the with since advantage thinking try is long-term merger. about take that to the of in-line data

Eric Joseph

and sequential smooth bit sort commercial I it overtime? of step-up on with one Thanks. Auryxia. Got the drivers price to there how fluctuations little behind guess maybe a cogs, about a some product to out seems just this in in And cogs? of they a just think bit would variability you be side on just quarter the the about talk Can side, of

Jason Amello

Sure. is This Jason.

that to from due cogs, in increase the really the of you and up the So if primarily of million, the is that base cogs, QX, at manufacturer at look when look you is is sales. related Auryxia level which to $X.X

around margin, level. So when it’s the you the that at same, XX% is representatively look that at

So that is increase. driven a just volume

The are accounting purchase that other related. two items to that gets added

inventory, that brought of on into gets that date the the P&L when So we units do of do you step-up saw of you That the Auryxia. evaluation is acquisition from the part closing. as

a million So that charge. $XX is

that that be per generally of is expect at way of portion generally that is you and look second if the projected $X.X into year. to million if will think The of that the in We continue sales, that that next speaking, cost about half you would future, step-up what twice period.

for reasonable use our that the and terms and amortized So That million, what Then amortization that in getting we that. license quarter. is expect there same of that is of nine-years. is is benchmark Auryxia, number to that to over every the $X.X the valued is on

Eric Joseph

helpful. for is taking That questions. Great. the Thanks

Operator

Piper you. question from our Thank Jaffray. Chris next Raymond with And comes

is now line Your open.

Nicole Gabreski

for Good morning. on This Chris Gabreski Nicole this is morning.

talked we the that about, progress to just sort about just the reverse Auryxia, should about you think opportunity So here? of also And IDA CMS' then how mentioned going decision, Can decision. on hard have you made overturned talk be you is But this rule it any upside. without coverage that guys being would forward? reversed, rule working

Jason Amello

Nicole, for the Thanks, Sure. questions.

So dialogue. first, question In we continue on second to have Everywhere. good I Washington. mean the very

even clear non-coverage at think value level of is a the I that in understanding change brings. our confident to And, that D there I ability Part remain determination. Auryxia very the

on. the are of side is On course, of the working government we federal this other that

they unfortunately. my are perspective, timing calendar, a from So not on

the and administration single been ago, So, positive when delaying but meeting improving kidney I weeks in there initiative pair is that with a has few this we said, cetera. from you and Washington on care et down progression, as was every President I have launched the that. when had

the data that are and about, we you Block Dr. talked proving can when is IDA we just drug. and pair that covering And, that And, the be progression. not we delay in-line to Auryxia's indication and

the I think administration's is what with are. goals inconsistent

So, that these to me, to we things are the that confidence that are a resolution. great going positive get give

most of we room of for tremendous growth of as that resolution, there share mean is have out X%, over get just have we hyperphosphatemia I growth coming is our hyperphosphatemia been indication. there. before is that to we said, driving Now, the market

grow even of to deficiency half coverage continue As about you here continue the fully anemia prescribing with so access that space and see like think you away way moving as about the think have hyperphosphatemia on through calcium, confidence they guidelines, drugs great from people to patients can think iron and we that commercial have play KDIGO where Medicaid things Auryxia. about we CKD or still to physicians

there to to So we we in the prescriptions opportunities growth without are that where very robust that are to-date. still be CMS the coverage, but won't certainly grow maximize significant from seeing space. can within is we have that and We able

Nicole Gabreski

Great and this accepted guess, some has be just I submission the for I clarify, if review and missed JNDA will been way. for but if decision then and that to not submission, in sorry wanted vadadustat I that community

John Butler

does So not indicate questions the we Japan now. that within like formally its pass send we that they it will of doesn’t of notify they are weeks have accepting the generally are few acceptance, a point they process would filing where FDA

I think a full we that are to and review. Mitsubishi So we believe way on

Nicole Gabreski

much. Thanks so Okay.

John Butler

you. Thank

Operator

Morgan from our Lebowitz comes Thank you. And next with question David Stanley.

line now is Your open.

David Lebowitz

read my also and taking when should guess studies coming I to extrapolate for differences away want extrapolate can you things do out much studies about what this and positive that data regard and question. from think highlight us that how very to might to came your earlier contrast. we you you compare take would competitive what out your guess to we have you year, from data what I you their since Thank

John Butler

David thanks for the question.

that roxadustat could or at safety seem the to all certainly gives in number fact that certainly So it’s in the I and would which that greater be, vadadustat. of be us issues categorized didn’t report mean class related. over on there confidence there release are things

So gives confidence. me that

cardiovascular On top release AstraZeneca, when it the talks you of that press confirming from about look at safety.

very we comment data haven't seen and any is that think a I course. important of

draw So stand from that encouraging. it hard negative many we it a I too quite no from cardio that are conclusions, vascular class that is to but point was certainly makes think a prospective there again suggests we seeing and

program program very feel prospective. clinical think program a from up like regulatory our ultimately set much success from for commercial And and their and and prospective I a when our is vis-a-vis then from about prospective really

got well dialysis we From a a us strong and end our this study prospective positive our very as have gives that as we study very with in clinical non-inferiority non-dialysis from again both comparator active an result a prospective. control opportunity point for think

It also the allows generated to and ESA. gives being this ESA in us commercial revenue of is that of comparison market $X by which standard that a being in this today is versus to us the compare. from billion do multiple Remember care perspective generated opportunities is

to To the compare physicians drug as take that, to you using have we more the segment, than non-dialysis of used to will opportunity much segment. have the the that grow directly able which to dialysis all be in do in market, more to the to opportunity recognize are particularly an

to advantage and wanted But from what a significant That sat non-dialysis said And from of we the an they in active the going the control. that have course, them. get you perspective. is And, gives is want FDA, right across We to I us first. that have give strategy. think got they to are segment, see the market you regulatory to to that

non- agreed ago analysis and for elements margin an for them, on And, we inferiority statistical year the a now have to key was MACE. plan. we agreed that, it I a guess start over beyond with just And,

data well commercial our in but now. less a a up from are we as only So comes perspective, from for we from not think a very success, And, well. up perspective regulatory set than as very, year set

David Lebowitz

or not on form at that that. also were for that following-up you least of reimburse that over temporary And for for just imposed, to was Thank there question. IDA, was a know period some jumping hyperphosphatemia was affect worked prior more I Auryxia way through. time, less and and certainly, its to a and Medicare the going to that going

John Butler

why working has was patients very through the a situation on that a tactics saw have put that, done help to place, hub, the some And at of the through you solid The get in job our year in et beginning the it pressure the cetera, the on So, folks of a and process. every unusual by team patient prior is authorization yes, to go physicians around drugs incredibly QX. prior field, have execution where prescriptions process. in through great the we authorization

is to in having was It to to It to aren't used very are go QX. a physicians that used had through patients They simply process. not that volume through prior of much who authorizations.

are So we that, really worked clear through we have now growth. seeing

and certainly to we I As that QX continuing are in said, see we the in see QX. number, growth

year, the I we And is we So, we be of hard of are And, we up working the say prescriptions. at confident to that. to do way are that so same it will through issue, it. next the are year, right see the the while on CMS very resolving set confident that think very in working not very beginning pressure prepared, I'm kind to also

David Lebowitz

Thanks taking my for questions.

Operator

our next with question And you. from Bert BTIG. comes Hazlett Thank

is line open. is Your now open.

Robert Hazlett

them. one guidance forward. just on regard on structure Thanks. you cash just Could in asked needs David capital my ask runway were repeat I answering and very clear the and just forward the you you. expectations thoughts to will broadly? going with Thank cash questions and going

Jason Amello

Sure.

XX-months QX are we beyond that. So cash disclose, as and we with we have XXXX into

So previous without guidance. reaffirming that is why we our

we one are of III forward in away year horizon that reading out. are from Going where we our we look program, the Phase at

commercial those business will and down, the time we be cash. be start costs So will more contributing the increasing wind will Auryxia and on at same to believe

versus next what are programs we going had while large III more Phase the are much our we on we near-term needs So historically had have enrolling. cylinders on forward a in going where manageable all horizon

also good product position non-dilutive the well. as position commercial other think of we to flexibility and now look So very a capital having are sources from a types we at with in that

John Butler

of points cash mean, than me more let just an point I exclamation Yes, have me on let kind there. we today. put Jason's XX-months of

but So that when were so we having always gave post through a talked we merger, product working about said, many us more no selling opportunities And, as structure. enhance there urgency, our options, for to we the the commercial are fact merger, capital is looking simply equity. versus the Jason

we balance long-term sheet. all we and commercial And But important towards of that is we is opportunities there are are well. the profitability. put capital to are component exploring those. And multiple exploring non-dilutive cash have to of have position time And those we product a that, an moving options we And on the have as do given all that of the today.

what fund the Auryxia, on few very where used need? our growth good It that So, we today ultimate significant is over cash. as we from And and a at program says compared to what feel our And, important words. we when we impact the we balance Jason what continue expect to clinical from to what look see sheet seeing and is, as raise feel vis-à-vis said, years. need are has right we this we to to Auryxia you manageable, as is, have do are Jason about the last very revenue

Robert Hazlett

and question. Thank you for taking for the the the thank color you

Operator

comes question next Difei And Thank you. our Yang Mizuho. with from

is line Your now open.

Alexandre Bouilloux

one think with you much would do setting? become take it think there? long be have good non-dialysis Thank think is commercialization vadadustat you that you physicians How the in on Alex in dialysis Difei. initially How the about for vadadustat I will you. do on This When Hey, setting. you questions. comfortable vadadustat. guys. education physician of the for for to the morning, Thank taking required

John Butler

Alex, thanks for question. the

accelerate of setting, And completed it the in if very the dialysis comp, opportunity they had as was on a with had you product the markets, transaction Mircera Mircera. in got very they VX are within dialysis I reasons Fresenius of patients XX% market. is right. So of use different to adoption the a mean, the the two from nine-months, we that the - of VX you And have course, one

is conversations way then they the studies, to in happen. about with the through. VX make and that protocol strategy what already we And, works, basically, pilot Now, it do push they they is, are that understand the

you the vadadustat have believe we population. adoption a dialysis So, quick do within very that can of

The non-dialysis market, what more the nice be is the on move a And out there product about year it of a is HIFs bring before and why to might of that take one ironically, product. education and another superior course, reasons adoption. we out think that time the is of company does talking more for is benefits we

And but We us what take is says that data the have that will the that see they allows our belief. done. to of advantage work

Operator

question Company. Chad from Messer our next And comes Needham & with

Your line is now open.

Chad Messer

are is patterns. your date you so if and know patents judgment. that people, out this a would have other have defend you the settlement What XX you is think stick, year a the on XXXX on of goods, March to we Par. kind against odds settlement is that This will based actually so from what have the I do modeling not been

John Butler

litigation five specifically with with Par modeling at list, publishes don’t and March the had potential you know been said fact looking we that rightly, given question. in are There we on are ANDA were as we are and Right we has FDA Chad thanks XX very we this are settlement we our lands with but positively believes influence think other the first until believe them filer, comment pleased that in they filer, XXXX to won’t we very, them filers for the that with We very where for a Par Par. quite the it, that was and pleased the but a some first date.

Chad Messer

a range then And great. and That the review is regulatory I than the or FDA what typical know of is time review less typical have defined Japanese process times.

John Butler

year a process, bit is a it right different in about batches are is do is about is I think about just Actually it different, little review. the think a but approvals is it that well a for it, described, you little they year and Yes. which bit of a pretty the way to talking

Chad Messer

benefit little and into you a per great you as wanted trying about less just adherence mainly PROTECT added be adherence. or Is three for week it to to to to when a problematic different the a of is then time flexibility that that. suppose it new think than got daily ask dosing is well, you that sometimes sort that back to of just of to Alright dose give benefit a bit park compliance normally or

John Butler

weekly it study to clarify just after dosing was times in dosing the So daily IVX an three study. has ongoing

we II few three that dialysis three we dosing had had and a arm as weekly Of ago study planning Phase in times course years with for also. registration a that published then well times we study the are it weekly

the is payment and you the a they And be fact the and provider drug the know and the the patients ensure their bundle. TDAPA XXX% that segment the allows the week chair vadadustat dialysis really compliant providers part rational want and for and that bundle, are rule patient purchased by to of And preference. outside compliance ensure patient so the be is a the would there fact their deliver in dialyzed that the can the dialysis to that certainly times with even dialysis three it around would

patients three weekly ideal. people be dialysis, will that a and of them is ideal perspective out our look from the be in once-a-day home for the dialysis as many the dialysis, those them still initiatives having center at times government that move option will is thousands center There options to having has the well. for So onto dialysis patients you of peritoneal

and how to is thinking commercial And is physicians patients about from so, perspective, have the delivered. have in that is choice idea drug -

Chad Messer

cost of that And me taking a by Okay. this you how the guess you through know, Jason, my this But long again goods, there I cards? is item a with that other with long question an that. because on flat apologies went I then this accounting how appreciate through I - to is on affected know we line I earlier non-cash XXXX. that just

Jason Amello

So, again both these remember, the key thing are of non-cash. to

from the the of is years the So nine date amortization acquisition.

same is that per million So the $X.X number quarter.

for basis number. that years December nine from on factor If XXXX, you quarterly a of

QX probably to inventory, we just that by half depleted. these we On the fully second way for you margin the about around step-up that will project take a value of And be this without charges. if fair year, that think next so, we expect normal think - the if the or is time

that So or QX number million value a XX% year. if in that will X.X on we that speaking time times charge, give be forecasting quarter, next two or by think are basis, take. generally that Again, finished step-up you this margin, this would be that half is twice second quarterly fair

Chad Messer

Great. Thanks.

Jason Amello

Okay.

Operator

question MacKay RBC Kennen next our from comes you. Markets. with Thank Capital And

line Your now open. is

Unidentified Analyst

from the program, for This coming was (Ph) for publications MACE rate Kennen taking wondering in the Question on hemoglobin event guidance affects that expectations is III since for us event quarter. on from question my thanks [Justin] Phase the and changes and goals it and rate all how initial where this progress predictions. congrats just Aranesp the

Thank your you. for So expectations essentially, been event with changes approval? have the there new any to goals, hemoglobin

John Butler

that. I you Yes, so study, on are you all are when and based rates projecting when literature you the designing of at look a available project mean event

placebo mean, about, about using rate, I If not what TREAT, really studies you Aranesp your like really you rate. really you using thinking are the think - the

kind informed, trial obviously, and has are the think will of deeply that And fully PROTECT into enrolled we about shortly. of it, be very we way now the kind INNOVATE

is lot be data a going we the think to how have timing sense events so of are in I coming available. good confidence And, And of when now we have in. very a of

Unidentified Analyst

very you much. Thank Greta.

Operator

you. Thank with Arce question from Wainwright. Ed comes [Operator Our Instructions] next H.C.

now is open. line Your

Ed Arce

taking for already in HIFs with Could vadadustat your asked particular Kidney new policy, sort in share in this risk Health and failure to ultimately around the advancing and particular? of reducing and think of have questions. forward incentive you going Hello plans care, being around and to want thoroughly, thanks but the and benefit access kidney the perspectives ask they answered goals Thanks. have. thoughts I been is of us that of that sort everyone, American enrolled that pretty payment did one you do particular, my quality Most improving could how and

John Butler

give an Kidney of thanks which the Partners, was for is care kidney question. And, be of with we initiatives really Yes, policy recently Akebia frankly. at for to that the that elected the the initiative for us some government going as community. table, work does opportunity the everyone in is And, that the organization head Chair Care industry, unique I kind of lobbying the obviously This on positive of is these forward.

So ones optional. these, schemes of I different think payment people that are that they mandatory and are are understand the still both some to trying proposing the

course, TDAPA that of I about for drug payments does is out of vadadustat, the on for payment the of years, TDAPA is add that and And, you think transitional when encourage rule. allows two Akebia bundle importantly, very vadadustat and think really innovation. adjuster

part And we - the on there our really think I to agenda on is forward impact like certainly TDAPA. the of But biggest helps with may drive see would still being one community. the improvements of rest us us that And, to today vadadustat. has the KCP again, TDAPA are to the

about around is we that opportunity on focused the to And really and out that given put schemes of us. of it block think payment that interesting initiatives they more about people you when particularly outcomes lot for Auryxia, dialysis much referenced grow. that think you there keeping really It that the When off dialysis, Auryxia that have near-term is a of is data had on kind are earlier. we whereas, key these

take for middle help opportunity initiative future. advantage to absolutely our and So, we right that, strategic the in of of the kind and Auryxia drive finding every that in of are vadadustat

Ed Arce

Thanks, is and john, on great. That the congrats progress. continued

Operator

Butler like to the to time, John Thank turn you. now I any questions back any calls closing remarks. would at over I'm showing for this further not

John Butler

Thanks.

has made to for are team and Have program really Thanks with progress call do the look the revenue updating today. executing We the Auryxia both forward joining and great pleased on a driving very on vadadustat progress. much very day. we the future that our you

Operator

program. you Everyone Ladies may conference. a wonderful have all for disconnect. participating in day. today's you concludes And and This today's thank does gentlemen,

Akebia Therapeutics (AKBA) 10 Aug 192019 Q2 Earnings call transcript