RETA - Earnings call transcript Q3 2018 | Reata Pharmaceuticals Inc

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Operator

Good day, ladies and gentlemen, and welcome to the Reata Third Quarter Financial Results and Update on Development Programs conference call. At this time, all participants are in a listen-only mode. [Operator Instructions] Before the Company proceeds with its remarks, please note the forward-looking statements disclosure in the Company's press release. The Company will be making forward-looking statements on today's call. There are many factors that could cause results to differ from expectations, including those noted in the Company's SEC filings. guarantees outcomes. not are statements of future Today’s time Please call November speak that any at X, transcript replay on today's comments made the accurate only be and no also any rereading. may webcast or note XXXX, longer of as of today,

Instructions] host of prepared [Operator for Vinny Vice we President today's for remarks, like now the open the conference, would Following up to Strategy. call will questions. I introduce your Jindal,

may begin. You

Vinny Jindal

discuss to our these Thanks quarter release our morning, Demetrius to and can management’s provide reatapharma.com. Huff; call today Officer, third of Warren. Officer, summary welcome I’m Chief Executive be results, results Chief review Reata we press release Chief and now . our development to and our of press turn the joined with a the financial call over Hello section on and found This Investors at issued a and by Warren a the Officer, Wilson. I'll Financial News our to Colin Medical Jason Meyer; website of our programs.

Warren Huff

Good morning, everyone, PAH. call. that programs study study in studies, the CARDINAL joining quarterly our I and omaveloxolone tissue for quarterly Syndrome; the CATALYST of quarter. the development of our today's of patients the conducting the Bardoxolone with we of ongoing associated results Vinny. connective a will that After made Friedreich’s financial in to review in pivotal overview call pipeline for bardoxolone ataxia; study disease you have our over since Jason thank Reata progress the is in the MOXIe three begin with brief for Alport remarks I us of prepared and for our advancing call. with and a Thanks, last will turn patients

in fibrosis by Bardoxolone FSGS, IgA failure loss In portion that caused cohort type after rare four PHOENIX and a from therapy with July, of a patients estimated key the X Results and CARDINAL delay for additional of well demonstrated are in benefit eGFR in we Phase significant Bardoxolone is include renal year the of observed retained In first the for significant following trial ADPKD, prevent of the X announced a baseline study, withdrawal. of Alport trial, with results knowledge, in diabetes. nephropathy, as eGFR conducting with that retained X evidence Syndrome. function our at and the XX one improvement of drug that the phase a week in portion forms addition, Bardoxolone, weeks long-term kidney ADPKD may CKD eGFR inflammation and methyl treatment we XX provides trial. eGFR final weeks are PHOENIX is is CARDINAL to CKD where the above the drivers produce and X failure kidney we data kidney benefit or of To increases therapy that believe benefit from four CKD improvement bardoxolone retained Phase estimated that in as

nephropathy between these mL/min kidney of increase that years average observed results that Historically function pivotal X.X plans rate PKD, magnitude patients commercially. will and at at week bardoxolone and demonstrated final from at Bardoxolone begin eGFR function X.X on of type of study positive of initiate and of cohorts. PHOENIX, enrolled XX XX year. entry. mL/min in declining of in for observed and diabetic we announced CKD in in We at significant, XXXX. we in eGFR is these X study the a annual of the we increase XX. which forms of loss in cohorts benefit significant, retained at of diabetic was suggest baseline for response CKD eGFR Historic Turning year, Based a the enrolled XX baseline mL/min at and increase XX on eGFR mean from patients, patients in observed XX. patients these their improved both arm to on typically one benefit to eGFR prevent increases of an to that In the and we at retained PHOENIX, forms eGFR significantly from in demonstrated announced to mL/min data Collectively, XX in significant of of potential to cohort September, IgA multiple patients We mean eGFR rate Week an in kidney across type PKD occurs Week demonstrated eGFR and at which X the pursue in X.X eGFR that disease. statistically both patients the results indications these Bardoxolone multiple a from care, enrolled we a prior baseline in studies week correlation one XX% the for IgA these mean cohort XX. increased to Week XX% treatment cohorts or three that nephropathy observed Based statistically the CKD statistically of standard whose delay X.X XX kidney has historic while kidney function dialysis was chronic declining intend Bardoxolone cohort,

fully half from our pleased study Syndrome, to data I'm the in with trial that available of line we second the ongoing to and X next the guidance year. Bardoxolone is study will CARDINAL this in top be are Alport enrolled of Regarding Phase announce patients confirming

second the with patients part Turning our the in our of are we to trial MOXIe Ataxia. activator in pivotal Friedreich’s studying omav, NrfX X program, registrational second ongoing generation

X X.X observed week in we in of roughly in at the also MOXIe, part X.X X.X p primary pivotal line effective announce that corrected to pleased of the dose with X.X. points, mFARS for confirming improvement of of part dose MOXIe approached results that which Based our placebo of placebo are a recall for with can mFARS from the that of statistically what of points, significant therapy part of and mFARS guidance patients the optimal this of study second optimistic the X the design is data a next at The top endpoint corrected value are significance a we on enrolled MOXIe the half be X the approved is scores ranging in part become dose in improvement part we in of observed and fully of optimal first X. improvement versus may trial and half MOXIe, omav year. I'm points baseline You at we XX, and FA. the will the available

associated in also proceeding of study hypertension that first to LARIAT on design in we over Based top the is first CATALYST planned, of XXXX. of become financial trial, continue X study for optimistic a and provide observed approved the we’re bardoxolone and from our tissue quarter. now expect disease the With will the the pulmonary CATALYST results data arterial of to connective turn to patients will specifically the with Bardoxolone results half CTD-PAH. available therapy the line call the be summary Phase Jason the trial that, I this for as Finally to in

Jason Wilson

Warren morning good and Thanks, everyone.

loss the loss last of the a compared the financial for As or Net or morning, results per $XX.X million XXXX. year. The share by share, decrease $X.XX compared the was for period both three-month loss $XX.X in quarter prior driven in quarter year net period we increased this reported same $X.XX million, an net expenses for revenue. to Warren increase and per is for the of third noted, to

million incurred we expenses by an development our expenses, our to in as last personnel $XX.X million The the total year. revenues related XX, product Regarding September quarter pipeline, period expenses manufacturing for of have to the increase we R&D expenses and license The primarily higher in for and ended same XXXX agreements. in are clinical expenses compared these increase $XX.X due and expanded collaboration of was decrease to development continued to activities support activities. an driven

As and revenue these license upfront agreements XXXX upfront XXXX. payment agreement. from we license payments a when related revenue obligation to entered from deferred recognizing has In from amounts then The deferred agreements during finished our received, into of as performance collaboration revenue our were payments received under during and revenue recognition been you an much know, XXXX XXXX, upfront probably from and of revenue recorded in period. recognized XXXX,

XXXX. it in no included revenue So in our is longer

determined course does of quarter past. during and balances in to quarter measurement, the expense made way KHK quarter from In revenue KHK of amortization on added our we of have third accounts quarter. implemented the the addition, reducing milestone that related and the to overallocated stock-based we third a we which total expenses, past required impact a to XXX and in the recognized compensation On deferred Topic this another be XXXX of reflected our we which expense. non-GAAP revenue. In excluding to that cash-based depreciation revenue milestone, payment we This the [ingested] was define have revenue in and revenue we expenses the changed and revenue not and first which the cash quarter as are operating third substantially had the milestone the note, apportioned some amount payments recognition,

included total news, can $XX.X months measure press September this reconciliation and three and subheading news investors A found be on issued XXXX Our $XX.X releases. respectively. morning, XXXX million www.reatapharma.com and events, the cash-based million were to website the operating company's XX, under expenses of subheading and for ended and non-GAAP at press this release is in the expenses

and continue the At company advance equivalents had well cash XXXX, With expenses and We our million our our operating the to expenses continue expect we equivalents, increase three enable we our the existing cash-based turn our expenditure into and we call I approximately for and grow development, past back to to sufficient fund XXXX. operating and registrational capital and Warren. into requirements to in cash be believe cash cash as candidates September trials, product will XX, over to prepare data that will additional $XXX us will on commercialization.

Warren Huff

lead XXXX year Alport initiated, understanding We transformative active and might helped and sharpen Syndrome on company. reported for treatment arms to our major We Furthermore the behave. launch reported that Thanks in positive Bardoxolone completed proof in has independent distinct both in our data pivotal represents chronic pivotal concept how a a of from trial pivotal XXXX, Jason. diseases, the a data patients of been parallel, the X Phase in trial began in ongoing in two our of company. program enrollment ADPKD. which two and preparations Phase we for clinical in kidney three rare achievement completed studies disease, X trials additional placebo

XXXX. and With years. X so soon to and of remarks, of in Phase RORγt progress. well data now in and XXXX, ongoing and sheet diseases the cohort registrational PHOENIX from FSGS next programs first flow, on to from positioned call our in orphan a of for studies modulator XXXX, including the of our data or months the in prepared of the coming to a RTA first again growing That for produce We you selective the to for the X Over half updating are generate questions. of results turn Alport a pivotal positive data Ataxia forward significant news and therapies commercialize underserved Syndrome Phase I expect potent the the the groundbreaking course operator in XXXX, one the will strong we XX second look top over we half concludes our portfolio more line of Friedreich’s and half balance full pivotal

Operator

[Operator question first Thank with Yigal you. Nochomovitz Citigroup. And from comes Instructions] our

may You proceed.

Yigal Nochomovitz

the to for Alport Hi, time is the on point, at XX-week as Colin, Phase retained weeks is or and the to check continue ADPKD, for going plan the with X? and taking to move as for to you that question. it that the study out study Warren stop benefit XX thanks then X Phase

Warren Huff

[integration a is would question. duration with four and PKD, no trial that launch is we XXXX, retained pivotal mentioned and there of we CARDINAL as good in protocol upcoming we weeks, would so benefit study independent that the and no planning you treatment clarify only And in analysis, the in is It protocol benefit the we specific we PHOENIX is know But different but protocol. longer treatment]. PHOENIX and have once a duration will plans obviously as sets than Yigal. Hi patients, retained assess extended so trial. XX we are contains to the the a anticipate The year can, of

Yigal Nochomovitz

Okay.

So ADPKD beyond this the longer at duration details are Phase – is point X design pending? the for

Warren Huff

weeks. Yes, we longer any registrational would would anticipate trial be than that XX

can. We we when will provide details more granular

Yigal Nochomovitz

part X XXX relative you given then have enrolled part the in and the how Okay, the similar the baseline CARDINAL Phase all are X you to Phase for the that have of the can characteristics at enrolment comment CARDINAL? been completed study, of on

Warren Huff

within the just will the expectations say our I eligibility obviously So, characteristics criteria. are and that baseline consistent with

We dive in those deep plan a medical have an meeting. will on to upcoming

Yigal Nochomovitz

Xs Okay. the cohorts you for are now Alport Phase and that with of diabetic type focus in IgA in still cards CKD, like on And ADPKD? or where and PHOENIX to some potential the is the thinking other is X respect

Warren Huff

cards. It's definitely in the

We indicated three pursue have indications, commercial and registrational right we now. type have nephropathy that diabetic CKD underway indications. the IgA trials plan X to additional Obviously as we

now to And We with next launch are start fourth to pivotal a we planning year. are additional PKD trials. adding will best when that internally as

Yigal Nochomovitz

Thank Okay. you.

Operator

Stifel. And our comes question next with Walsh Adam from

proceed. may You

Adam Walsh

ASN quick the cases the AE of entire findings maybe showed profile, what was as and a clinical us, you you. part trial just have elevated enzymes history morning. the the Bardoxolone Thank results safety maybe at liver populations us could for experience? good of few Hi, patient those across from what PHOENIX in the Collin been then contextualize has one shown liver remind trials for of Collin, couple a I a

Colin Meyer

Sure. Adam. No problem

those so NrfX, is of is of transaminases target pharmacodynamic we so occasionally which and a ALT regulated it the notably by see And elevations AST, and effect. Bardoxolone, are

we liver trials. We case been Clinically plus of treated been notably of actually Hy's is of very total follows so reduced. have prior the and has actually primary Law, BEACON we function, events and probably bilirubin after In of case fairly treatment. many group typically adverse half Bardoxolone marker never elevations as occur with were seen quickly in see distinct never liver there Bardoxolone know to it bilirubin the in And as There the pattern. believe trial. toxicity, the function. a hepatobiliary the improved total serious we patients initiation XXXX It placebo, you in was a a liver have relative

We have of years meetings investigated at I we pharmacology the medical have in-depth, transaminases think and posters had ago.

importantly that of increased there most is we administration transaminases. think I in have culture of production cell upon Bardoxolone demonstrated

of production knockout NrfX, so of reduce you genetically increase if genetic if And NrfX, manipulation transaminases. activate you of you transaminases, production in NrfX, models of you

And is liver we to be think it our to a don't trials. so do if in we potential monitor course, a we to in case of with seen actually clinical toxicity liver regulated have simply clinical again actually there ever toxicity, toxicity, miss pharmacodynamic of and do what the trials liver just we that it. make our going any that of evidence once clinical effect in trials We changes with was observed is is zero have the nothing of our consistent and But sure effect. them, there

Adam Walsh

Thanks for all the color.

Operator

And from our comes next Raycroft with question Maury Jefferies.

proceed. may You

Maury Raycroft

everyone, taking morning good Hi, and thanks questions. my for

eGFR relates across eGFR in and to different you can you or proteinuria decline of in just and the particularly to provide KOL how rates wondering perspective then Proteinuria that if cohorts of levels question, out see sentiment, different First [ASN] respect on Phoenix. coming this

Colin Meyer

Sure, Maury.

consistent traffic animal pharmacology of diabetic by there to elucidated what that been have very supported is have very are XX we models. produced the before. that completely that profile think pattern. seen the have different now and a we across now forms CKD lot four so that clinical many At with the with I of chronic disease peer people different understanding KOL's we etiologies a in So, rapid manuscripts and ASN, show presentations, kidney various pleased In reviewed have caused by different consistent is obviously data the over it's presentations; we've data

increasing effect specific to has Which of cause eGFR, questions of your restores in something cellular animal due not there is and pressure That increase may carefully occur. some GFR. The that surface ultimately constricted been injury in GFR then does the question it few months transiently as Proteinuria, a pattern. hyperfiltration. a period basically and that about that specific if a within far the kidney increased of loss shown a is importantly restoring very increase that's area As GFR to We've called just inflammation models of non-damaging the in the GFR. drug in very

We’re durable BEACON CKD and the and trials, CARDINAL is and in now the one for syndrome diabetic at in shown Alport year. trials. several BEAM effect including That least

including retained the and so, of And is trials, very three and benefit from different large. phase the once the rules magnitude This CARDINAL demonstrates is out harm we've importantly, quite to in disease again shown II modifying pattern distinct activity. trial. kidney That And hyperfiltration. a now

for data the damaging. is have see those very community the been that think I nephrology mechanism helpful not so, And to

Proteinuria potentially As is cited again hyperfiltration. evidence as that that. pattern as is But concerned, that's far from our is often distinct there once

and the think of of the if and patient increased and the back and different think sieving filtration is about enters trial. there's there's you because damage the if present CKD, our the I forms of protein an kidney to basically step damage when disease process, clinical barrier

GFR, you protein. of you'll filtration or increase If sieving simply increase

And ASN. highlighted and actually see is maximal, in II the Notably, and GFR. Proteinuria our our for output then in we in trials. II And one by did type at syndrome maximal, is so, diabetic trends our year accounted GFRs the that data that after see down. And trial change we that CARINAL increase CKD do diabetic, was phase that in

ASN over baseline. Some was one trial, released who actually entry, of were base demonstrate, there's is levels highest Macroalbuminuria. of different drug level on the washed line. retain what that the that we it and patients withdrawn year Proteinuria who in And new from Once out, additional phase II And and the upon average in demonstrate we demonstrates and are end gram released, we different those on time the eGFR, our that about only had not CARDINAL Proteinuria reduced no Proteinuria. data overall at significantly Proteinuria not is actually have that data benefit

an reduction fore So, it also But the patients. pretty change increase. observed, patients GFR. was high. initial kind There demonstrated actually on body of in was was Those it those a large

drug While below was the base patients slightly line. XX, were every it actually on

down And again and eGFR. when and a sub-side. to washed reduction off suggest in so, retained on benefit would patients And There was Proteinuria came actually XX% but out once not numerically. that up in drug

meaningful. very actually So, that's

now our different CKD. you And so, is of profile across hyperfiltration. anticipate distinct our clinical the the same data all-in-all data effect. restores in forms longest very there's has evidence novel, pre-clinical surface been observed durable our This in seen is from It's effects and many zero that profile I profile for think it or tested. actually the We area and very pressure-mediated the that have something from we've very would ratio GFR distinct. what specific And drug

Maury Rycroft

away that's that. and helpful. very of from just take Okay, a kind And

really space So, Proteinuria type as far Proteinuria to high base line. on as or not goes, patient either Proteinuria you're specific limited low

Colin Meyer

correct. You're

think our one program. from I distinction that's our of

add on And I bit Proteinuria to little a color guess and the discussion. so, more

and in And do initial see In in II we increase cohorts, an syndrome we a the the increase. studied, in Proteinuria. had significant patients CKD and other the where patients type filtration so, diabetic this output while see barrier we to damage other not

Proteinuria. nephropathy was cause PKD I increase and bardoxolone of in In no Proteinuria entry in increase Proteinuria disease in there the patients, the increase was not in those that's point in that patients, there patients of patients. primarily the type diabetic normal an or tubules cysts formed. no did so, sickly in Those the IgA Proteinuria. have And Similarly,

a different produce, can trials. an select surrogate, Proteinuria because they FDAs of that as of they a which on is marker think our the distinct important on pin the is dialysis transplant either so mind drive FSGS, limit once endpoint patients other in so, of that's point. to showing feasible simply that in don’t high versus they're change surrogate all patients come interventions a of obviously since effect high a surrogate of have surrogate nephropathy acceptable We end a eGFR trials a trying of potential is not And status. and than, then that and CKD it eGFR would are now baseline you so rare determine outcomes. there's ongoing effect to companies of Proteinuria a acknowledge patients reduce since and and ideally prefer of Proteinuria All placebo. Proteinuria. for data's And events, trials if in a again And how primary IgA a levels that's in entry reduction as surrogate forms obviously upon Proteinuria in with our I really is very improvement Proteinuria just with that to is levels those the can eGFR, or with and for to has have the associate eGFR us

IgA single For in we gram often level nephropathy some the for inclusion that's enrolled, XX our threshold the reference PHOENIX had trials. patient used who a of in not that's trial, patients only and Proteinuria

actually in see if think being simply when most I Proteinuria that high of have don’t patients, unbiased so, enroll care. on cared adequately for patients they're of And standard an levels manner we extremely you'd

Warren Huff

chronically we low reduced patients care, think one ACE on we with And GFRs actually are of, have something significantly done they've appreciated job open-label level and not of vast inhibitors an standard and protein patients Proteinuria see excellent the than across headed mentioned, ESRD an declining. have I the still and majority treating or event. levels, of trials well have kind nephrology it that's gram receptor. see our those And as Colin but in angiotensin community the that's to trials are patients yet less

Maury Rycroft

it, very Got helpful.

one Just quick question Friedreich's more on ataxia.

and how on the aiming foot II are well. if know as part compare of if comment and And just you in the talk just deformity. could they Just with you for specific about I. generally patients proportion wondering you I can that to part patients

Warren Huff

III population. similar very think I to the so CARDINAL and the So, answer question phase about

medical line we'll with disclose details So, future at characteristics a base meeting. the

great patients take do our to sure think appropriate. be we we trials, we that would As care who enroll with all of make

to to part And previously insured we kind caps requirements engineered trial. population patient would and the that enzyme so, the similar of of that I those be we studied in

instance, patients for so not XX% a that So, cap a patients was cavus, foot of or there deformity cap pes was with of and exceeded.

Maury Rycroft

okay. you, Thank Got very it, much.

Operator

Partners. next our Leerink from comes with And question Joseph Schwartz

You proceed. may

Unidentified Analyst

for dialing is morning. question. for Dan, taking Thanks the I'm in This good Hi, Joe.

I and didn’t know specifics. So, it's early you any really provide

So, renal I want if to plans more particularly to a CKD your various granularity in I just can see indication. the gain attempt Bard little on

regards ADPKD with So, with to the pivotal trial initiating XXXX. in

on of question what all have specific based one that way precedent other it wherein the previous in your XX your predictability wondering that the than PHOENIX shown shorter some pretty how assume year's the CARDINAL, by to benefit asking good XX experience. in to Just units tolvaptan I'm going shown out. have to eGFR and or is weeks sort four related safe you'd out plus And is that. seen XX-weeks the you're reason the weeks go something to to

thinking duration? you PHOENIX like XX-weeks you Thanks. week for other shorter your need field guys benefit can terms go plus in you retain some or the are the trial how I'm necessarily pursuing. like So, in someplace Do of four about the of cohorts XX-week

Warren Huff

Yes.

eGFR at change XX-weeks correct predictable change has are year at you and one been So, drug. on-and-off of that the the

at approval. active approval XX-weeks. And despite know of already full having that's have the in drug I pivotal think few we is to endpoints requires a and The CKD least trials is two relevant a believe regulators type efficient for at determined accelerated duration years treatment. of various the importantly, what

you full the in eGFR syndrome any if look two the minimum be ours or recent endpoint either or determined CKD based so, approval cost a by will And years. of at Alport IgA others and FSGS at in and trial,

we from similar anticipate that would to our have a guidance with what receive so, would perspective, would before. be of we kind And we

for year two one treatment approval. full one year with then a two analysis a so, potentially year of and of years accelerated approval, trial And

plan. kind that’s of So, base our case

Colin Meyer

and I clinical year that We don’t diseases trials. we would off just treatment week-XX. off one in at add data two now have to three data at treatment in have

so, to was We XX-week a predictability that at to. and treatment deviate would it that get want off study the want design We know earlier. if And you we just mentioned standpoint treatment even standpoint, to from possible as year. from on one and predicts data would not

that's the we would the so, And way propose study.

Unidentified Analyst

Great.

follow-up. regards to PHOENIX a With the just So, cohort.

ADPKD on half or I diabetic laid waiting other do from an scheduled Aside timeline the a the already indications type out in for haven’t meeting you 'XX CKD. FSGS first basically discuss? have II next to make Thanks. update you you those really for before plans plans, Are the you or end-of-phase IgA your

Colin Meyer

were the waiting we're based on resources. not to FSGS counter our personnel trying so, triage And We current data. simply and the appropriately opportunities upon

trials. mentioned so so, we pivotal And have three ongoing

in and So, syndrome, CATALYST Friedreich's the sure as data ataxia trails to they we underway. the CARDINAL to ADPKD bring appropriate. layer for subsequent XXXX. we with trial make and our and from MOXIe CTD-PAH, a will trial. trial and pivotal Alport trial phase positive that the need hopefully execute the Obviously, And In we're adding on fourth trial pivotal home need III

year As bring have the submission efficiently and next two And in we and data that those then as from drugs. imperative obviously and and half Warren second so of two possible, first successfully. the commercial proceed mentioned, it's as rapidly trials to we March NDA will those

priority. So, pivotal trials priority. top secondary, that not will be And then these that's a our additional

Jason Wilson

question a sequencing. It's just of

Unidentified Analyst

Thanks our questions. for taking Right.

Operator

[Operator Cantor with comes Instructions] Charles from And our Fitzgerald. next Duncan question

You may begin.

Charles Duncan

Hi, guys.

year looking something perhaps of clinical button And questions in we're for have only prescriber I on is a basis. like two and those market that but it's and commercialization you alluded It and Most a Alport First questions. our about perhaps wanted really year; at been It just in my progress are to like of not the to thanks all, fast one. been Friedreich's even congrats to pivotal taking but in good forward asked the press divergent ataxia. go-to sounds data, plan. seems be going also the

any surely a to So, recent interactions AbbVie. on regard strategy. And I'd hear go-to I partner any color like to then you have and market ask follow-up thought to some old wanted the with given with

Warren Huff

that. diseases come of out good in success. their with in the launch virtual products Sure. of very in areas but And and obviously initial they're rare Friedreich's very on actively and both a Alport potentially launch Yes, both They're I'll that designed and that of characteristics we're ataxia parallel therapy. have Charles, therapeutic conservatably the no for CKD positively. and a also They're different them approved launch assumption orphan have both preparing take similar could studies syndrome probability both currently

disease. patients. Our case, to we in the endpoints having Friedreich's are And would far modifying a support the the And is disease believe with is clinical that a improvement very designed ataxia, measure in therefore data Alports to the correlates there score in show the retained those effect very living activities very daily these meaningful would clinical meaningful highly of benefit patients. that showing and benefit be of drug in

data kind therapy. also played and our think So, for in increase that IMBRUVICA, Commercial disease would Last space, ground over And year. the additional a no We've launching out know these of the We've lot Chief with A and of trials been function on that Officer. I team see is expense functions. related laying with particularly we're product. CKD orphaned our who scale, role work in the support year. launch significantly of have also, approved in functions building she's this preparing had rare you Bir, as we've commercial the today in during manufacturing building have that that her the affairs being year of expanded to commercial year, year-over-year. to team medical Dawn reflected modifying clinical key you therapy claims building potentially disease last joined the

also the United rights of with retained to recall in commercial the We and bardoxolone we've and a that CKD, respect economics XXX% States.

commercially the a Kirin commercialize in with in option Hakko very has elect We rest preparing And indications have AbbVie, plan will of They'll course Southeast have and us the to one which an think elect III territories Japan, territories. of active to they outside data. world they're substitute election partner And those have presented option phase in territories. the Asia we launch or onetime partner Kyowa a those a the three the in outside I would would with in is will happen they Kirin territories those the things of case of States have to either in product the we along actively be and the way launch of will to launch rights United return when there. in and And to for territories. those and which

Charles Duncan

number fairly well Alports helpful. -- through at be community differentiated as that profile this I'm of reminder like you clinical assumed effectively other a omaveloxolone. drug. as the if It's and be efficacy people size, wondering bardoxolone guess and of relatively it terms and The least well reasonable I of out patient effort could in diseases to a marketed an organized or given ataxia. Friedreich's think commercial A population impose that could to seems

Warren Huff

engaged this -- I to in think disease. the has absolutely I an FARA, commented job Friedreich's there ataxia, but long-term need]. with registry, them. done been is Yes. before huge take very an very hope. we've active with It there collecting on mean, is disease data. a just say And group a little I [med patient patient active extremely But They're a very think existing is terrible if is fabulous you disease. an they've affective been patient organization There a we've and

therapy and the the outcomes. we into therapy topline CKD. with yes a of a the is, be But And than can from we launching with label. for earlier. efficacy kind of in no that the currently approved deadly analysis with phase presented II, data syndrome, were average ACE those lot used robust forms substantial disease you and we for Alport most approved in is although clinical There see off GFR in have demonstrated rare one diabetic arms a of there severe it, populations terrible specifically would were drug CKD higher trial a similar of it's inhibitors that observed are no So, declines

at risk progressing to that. failure high are patients of kidney And of consequences and so, those the

can are And and but And a think good, no of both commercial try deadly a your very therapy. own us. for again about very opportunities pricing them conclusions rare disease good so, you approved penetration it’s with we

Charles Duncan

an Thanks color, XXXX. It interesting the Warren. added for should in year be

Warren Huff

You bet! questions. Thanks for the

Operator

with Citigroup. And we Yigal have Nochomovitz from follow-up question a

proceed. may You

Yigal Nochomovitz

follow-up. the taking For

potential question internal you disadvantages little the to there a AbbVie one? Just Thanks. question. to have the to just more to prior the And as whether bit the outlined comment preference the or yourself? a re-partner potentially AbbVie conversation Could of advantages is two on opportunity the scenarios prefer have you'd in elect or

Warren Huff

much about it. say I we really don’t think more could

If it At rights to of product also option launch be be us excellent sure other the same and they're do would attractive option AbbVie the job excellent time, return offshore us I an us. extremely into project, having partner. an elected obviously or the I'm and in giving we the to commercial would to think partner they the commercializing would of the either territories. the

I are from sure timely those goal think our make we of the on effectively a product good And number a and to So, standpoint in launched is our primary there gets basis that options. territories.

Yigal Nochomovitz

economics just listening, the to they have make and contribute the they to to And some] them to upend, if some decide to development? isn’t us can everyone [monitory are you pay remind there what

Warren Huff

Yes.

just So, first-of-all, territories XXX% double both, are all of territories territories we've to all by in the and of territories burdened just the a offshore the in reiterate, including to royalties U.S. us. potential the economics Kirin and retained digit AbbVie the

In a in, to addition they're for to would that, reimburse AbbVie would -- have have, elected if us

Jason Wilson

It's a XXX%.

Warren Huff

cost cost then development to-date. that. XXX% be our And of a sharing To after would

Yigal Nochomovitz

approximately? is disclosed amount what you Have that

Warren Huff

No, we haven’t.

Yigal Nochomovitz

the all follow-up. taking Thank very you Okay, right. for much

Warren Huff

bet. You

Operator

now turn Vinny over closing the remarks. Ladies to this like would and now Q&A for concludes Jindal back gentlemen, call question any to call. our today's of I

Vinny Jindal

progress for care. looking everyone, our Thanks in us soon. again morning. to Demetrius. joining updating We're forward this Thanks, Take you

Operator

for disconnect. conference. Ladies Everyone, the attending thank And and program. gentlemen, you does all you may wonderful This conclude day! today's a have

Reata Pharmaceuticals (RETA) 7 Nov 182018 Q3 Earnings call transcript