RETA - Earnings call transcript Q4 2021 | Reata Pharmaceuticals Inc

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Operator

Thank you for standing by and welcome to Reata Pharmaceuticals Conference Call, during which the company will discuss fourth quarter and full year 2021 financial results and provide an update on its clinical development programs. An audio recording of today's webcast will be available shortly after the call in the Investors section of Reata’s website at reatapharma.com.

Before the company proceeds with its remarks, please note that forward-looking statements disclosure in the company’s press release. There are many factors that could cause results to differ from expectations, including those noted in the company’s SEC filings. On today’s conference call non-GAAP financial measures will be used to help investors understand the business performance. website. are release comparable which and be on measures in financial again financial found earnings Reata’s presentation Reata’s non-GAAP reconciled GAAP with measures can These from today, outcomes. Today’s statements guarantees are of not future note webcast as today, longer replay rereading. only be or also call may the at XXXX, of that on transcript February made Please today’s comments time apply accurate and XX, no any of any

the to call you Following question up questions. the will prepared so that yourself remarks, We accommodate questions follow-up please one open limit can as one we and ask we as for that many possible.

joined Chief to Meyer, Reata’s I Chief Chief Huff. Commercial the and Chief Officer, are Research and Chief Executive Colin and by turn call Officer; over Chief President; Khan, Dawn Financial time, Seemi Bir; Soni, We this Warren Officer Officer,. At Innovation Medical would Operating today Officer,; Officer; Chief to Development Huff like Warren officer. Manmeet and

Warren Huff

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Colin Meyer

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Next slide.

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Seemi Khan

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drug endpoint We four week the treatment year one discontinuation which have planned baseline change which is after eight from from eGFR weeks at week changed week XXX. in change XXX, drug at from weeks the XX, is discontinuation planned at primary EGFR off baseline the to after

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Manmeet Soni

you, continue on Slide good Khan, Thank morning, XX. and everyone. Dr. I'll

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Next slide.

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Warren Huff

FALCON of the the severe setback will working early of this Kyowa first be long-term that study trial the efficacy an our next our position we're available will events provide study well drug. the from the to bardoxolone Kirin’s in commercial treat Omav actively submission the patients In positioned treatment the with program and disease ADPKD. of our on syndrome to continue achieve to on to program. year. goal next same important working FDA approved, Thank of with will large, the for complete Alport launching product. AYAME Alport preparations a closing, quarter. patients time, FA also you, and launch Manmeet. the assessing milestone commercial for on for a be in We're development the from program believe If first At and Omav drug be the and recover results steps safety we’re U.S. data this to enroll Omav We in to NDA and the track of and It our we're syndrome in

Additionally, a we're patients to in looking diabetic XXX this initiating with X later nephropathy RTA forward Phase year. of study

with remain for the strong therapeutics position environment. we of we cash the novel this treatment As our goal providing commercializing and doing diseases. of with continue to severe flexibility with patients us efforts, developing in life-threatening we’re necessary financial pursue so committed Above all, a these to

to So our turn in that remarks. thank who over the questions. for operator like call to I'll now dialled prepared concludes We'd and the everyone

Operator

Citigroup. first will Nochomovitz Instructions] from gentlemen ahead. at begin this and time from question-and-answer go please session. comes Yigal, Ladies and we [Operator question Yigal The

Yigal Nochomovitz

very thank Hi and Hi Warren great. much team, for questions. taking the you

a time time a mentioned to baseline So composite is exclusively of slide, a and ESRD. AYAME has greater times in as then which endpoint highlighted secondary endpoint time you in the eGFR AYAME and XX% remarks you to in also obviously to the or is ESRD, decrease from numerous your than primary

ESRD, and enough outcome your Alport hit, far NDA? on to AYAME do is, And that be you. time FDA the seeing interest hitting the evidence this So, data? assuming positive to would has be primary believe show view question which to any really in these Thank need of or endpoints resubmit modification thus secondary disease expressed in enough work, endpoint you would isolates to my you that

Warren Huff

it's question, large well is there so of that as of the hard that so part that when eGFR. are Sure, XX% at the implications FDA. do beholder, design of be and be with I that dialysis going I take part start or No, To number of a plan comes discussed the minimum the and as long, large, to large haven't in XX% the first with I'll study eyes will take I that it question events think a the AYAME we to think first. what last large data that at declines XX% of I’ll in. and the would the in

going provides we be the in actually dialysis in large evidence significant there the ideally with also that I and meaningful trajectories a going to to if risk a a dialysis think I be in the that observed a events. if persuasive of heart the clean reduction, reduced persuasive. events drug if declines was it translate profile very is so significant is increases safety time, that eGFR events that to proportional the is extremely think heart the reduction because eGFR, over into saw And dialysis

Yigal Nochomovitz

and Okay AYAME. up a follow quick thanks very much just on

of visits patient top data up the second also half show is year? the the line so last we second the are to this the So, year, that half of expect going in should

Warren Huff

have Kirin’s to to you...? you Manmeet do on data. the release guidance look plan to they when No,

Manmeet Soni

last have their half is is Manmeet not They Yigal. guidance coming This in would not Yes currently. second currently guided. that the year. have this Warren. Yes, of they They've patient current guided

Yigal Nochomovitz

ask on FA. just then Okay could and if quick question one I

the questions in to what an is drugs? and to positive obviously request disappointment hard be key AdCom But very table? following the would low a that given it's as does history envision FA believe the and discuss know long to if you issues X what the you So, of FDA they have FA do said having data developing Phase would want that, bring bar very you would

Warren Huff

Yes, I know, I agree.

mostly think think it's of would so very is The just well they the exactly the agency clinical discussion a these I I don't of be really patient really that or bring. data is I demonstrate. issues progression by for really shortening set some neurologists, meaningfulness of the know work done which panel in The reduction there to a understood. that great in there general assume and of and what rate organization, are is would straightforward the because time I patients the is the change of suggests over easy FARA, significant

other it, the So the would really with don't would discussion I what those know to than very discuss but issues be that, manageable. seem safety about. potentially I have guess associated

Yigal Nochomovitz

thank Okay, you.

Operator

question at please Charles Charles, Fitzgerald. ahead. comes from Duncan go next Cantor The

Charles Duncan

I and on the Thanks interaction challenging I persisting a team, could with guess taking and you say characterize versus for and agency bard the Omav Warren had I to a at couple through interactions I its know what going on in think this the up but agency the and you're details, Then on follow history you with about a process. not Omav provide clinical point the I'm question, if Yes, morning. your on time. yes questions good of thus development? of had data. the of Omav. do wondering some the probably perspectives far

Warren Huff

the from a a throughout provide provide them they to took is was a that as that Sure, requested us as them the Colin we single to position And and approval, for pointed us last for Charles. the know that to out, this us after we with appropriate for providing the in meeting, NDA meeting of it in that support pre-NDA interacted filed, data, and results Obviously, needed so the discuss on we us what dialogue he engaged analysis study delay-start submitted would meeting our it year and meeting positive Type background a the context asked that of FDA to initially that Part we we know, to additional the request do all And and traditional analyses. they Type told different with they X, and suggested for C that needed study the summarized. that division request to the they we analyses MOXIe reviewing more additional use first when focus with pre-NDA C withdraw get pre-NDA came meeting. you back also that a to and the questions around

and a They much studies on pre-NDA believe they to provided delayed-start post support then clinical NDA they really for preclinical the And took us meeting. of submit approval, of very focused straightforward gave to the us approval. was meeting, of studies allow on They to the content it also NDA, and the the requirements in analysis us -- because that the we they allowed So, on content that their the of dispensation as submit of the disease. the a number also type the comments pre-NDA certain severity pharmacology NDA. additional

did. where of discussion also told are. did to meeting. really was approval. the did of submission, a were be ask also track, it supported we accelerated which topics and the and going They review They fast we submit that for we -- basically granted So us we full. very submission They had we very invited full for if following track. rolling us invited sort so was which We’ve the tone. thought issue cooperative rolling submit during to the so pre-NDA us or are said a of main a data that's kind request would They that that They those that They granted meeting. us -- fast to said the

as the we I think filing opened provided as, think, factors NDA for that other the door well analysis us. additional the for external that I

Charles Duncan

I Okay, know answer. that's difficult helpful. I a it's to question appreciate color. the

Regarding filed that Slide would the events, the that, and wanted you are review? adverse once thought NDA that to going with accepted any and to a assume build increases, you you for XX them and to ask if then I talk you're regard I ALT particularly of the if the And that REMS do you construct that? program, would be necessary about launch, you is more Omav think prepared to suggest pre-commercial

Warren Huff

Yes. that -- Manmeet, would first? take you

Manmeet Soni

Sure.

remarks, as refocused prepared and marketing is this we priority as are have, launch team towards have in last -- towards our already payer launch. had I we hired mentioned team, my Manmeet. which sales hey we Omav focused now year, we commercial were they and Yes, So Charles, as Omav

targets, that it's So initial work that underway. initiated, and it's is working along has with well if already disease all already our awareness all sizing

Colin Meyer

to those respect with strong well the the We of of a purely there's that particularly think enzymes. that very question, first those the take are effect transaminases, transaminases. I'll evidence induction

have think I very of and clinically associated increase profile also off have meaningful high other without the or evidence specific -- bilirubin. They levels injury acute of with Omav that a or cases hepatic We observed think in are law so no an that with bardoxolone, actual manageable. transaminases increases

would REMS think so for would observation And we management but label, them don't be in of and careful I recorded propose the that.

Charles Duncan

queue. the for my taking thanks in get question. back I'll Okay,

Operator

comes from The Maury next Raycroft question please go Maury, at Jefferies. ahead.

Maury Raycroft

items to point for Hi, add submission of end point? on of by my for specify and a guess I CMC manufacturing at taking you're I'll good with NDA and follow-up can quarter, what commercial say remaining at this first the you the are thanks and questions. product complete Omav. morning NDA, where this at

Warren Huff

it's yes, delayed Yes, that to we've hard both March. CMC with quickly. is Yes, nonclinical clinical modules activities, last speed to we're in have so CMC. go But question, behind, completed they submission, they're when and submitted the module were on track in Maury. we got and will up last that the thanks the and together the for month the the remaining section and Frankly,

Maury Raycroft

it. Got

year just Okay, just because get you related wondering Kirin, three you but the additional it's can't provide say if and color on in or some longer study? requested to to JPMDA why much AYAME can also data probably the Kirin

Warren Huff

are damage and in certainly, were functioning for have of I'm of, concern. the speculate, GFR, bardoxolone. because development amount there's evidence has normal because in manifest, them. been it increases you pressure of individual Kirin going the pressure-mediated, about a I'm history are of basically going acute understanding of speak I But treatment. eGFR answers I'm manifest assuming that the a think, that they're and that substantial not The the been fundamental Yes, concern medications, to to but nephrons. three provided and restoration we've just the there blood the question increases single-nephron amount not But the that substantial if years provided have would to that this, there of of a and theoretical pressure-mediated,

definitively, data long-term question. that the truly And the answer so, I to PMDA see that suspect I to wanted believe, definitively

Colin Meyer

average about exposure years I I the year think think took enroll they'll a X,XXX I'd to about just it study. patients of with add, thatm X.X have -- them because an

And that the three every so, exposure. has least of requirement years think patient is I at

Maury Raycroft

Got it.

questions. my taking for thanks Okay,

Warren Huff

Sure.

Operator

The Annabel Annabel, comes from go of Stifel. Samimy please ahead. next question

Annabel Samimy

Sorry.

Sorry, I mute, for you taking was on but my question. thank

relates number to that it I bardoxolone the ways to syndrome. a I resolve issues Alport as were CRL, to of So the brought related guess FDA in noticed that them specifically

were the you of to then, eGFR a what wondering, just you think specifically you what you're now is interim you number are of taken conducting studies that at look just was not get that taking and was I'm Warren, else I do or the I point? it was XX-week Thank accomplish potentially us other you. of separately, there, maybe to that remind answer guess could these the of any away they're And with intent you've requesting away of questions? something that you review patients? with XX-week there that studies the So syndrome can the Alport in now lack AYAME the guess trying accelerated review, these initial any in And the can address have review second those ADPKD I specific the trial, requirements that question that that time

Warren Huff

to year the off idea support were have which on on of I then a we blinded and in review. my data, to close two proposed the and time treatment full accelerated XXXX, year into the company, became have so think, year collect ago, and during they the first to have second basis completed We when Sure, we based yes. would the a we it willingness data, study, to approval. support that year impacted second that meeting, CARDINAL data. was were the the back submissions Years And that going were conduct continue conduct our And that year to to their data well for of the could data, the for potentially year one we having study, second belief regulatory the the a we clear it's requests make the to that people that, we when in were approval FDA the the And involved by the one patients data, the suggested could design assemble that the design. study investigators, take meeting the X-year data.

year the issue of FALCON with and had, respect that pre-NDA study, going one submitted likely take to for to with PKD. but one. description so agreed conclusion led the just we interaction, off-treatment we take same And two issue the or yes, have exact our we're so the the during the to basically the and I we're to essentially won't that year same timing submit to division not the a that in After we the forgot said, the the they data. So for meeting eliminate to and interaction to said just data year

Annabel Samimy

Okay, got it. Yes?

Warren Huff

question, eGFR application in specifically in book, syndrome, positive CKD. their conclusions, And did we was in Alport respect of first or didn't form have they to, the in deficiency data that study for stated another with briefing not the respect of clinical they in they say but asked in to the that CRL, another their endpoint specifically one

unequivocally the think that, to to Alport with was did the I we have And If data. leaves supplemental think go we the And we probably if so have syndrome that I AYAME want open would back obviously with discussion. them. resubmit positive, FDA request would the to NDA particularly discussion that and

Annabel Samimy

that, Okay. Alport did measurements ask specifically I think just they If drill could I for on some specifically. quality-of-life for down

can is think would or pull that else from any anything that you provide with MERLIN them there do of pull you So that data? can you that

Warren Huff

interesting that patient-focused a on the is comment PGIC, had that you measure, in effect the what's we can about that? is which significant Yes measure Colin, of PGIC. a

Colin Meyer

change global that not of met if secondary year where actually is at patient just and overall trials, unchanged, types trials, that's The worse endpoint of and or report our was different many they're trial better, in pre-specified doing kidney used impression in patients significance and a two.

data would to those address to back their other believe data take this to and try supportive we as concerns. want with data we are Warren so And said,

Warren Huff

on they I think they endpoint I of its CRL, comment regulatory comment in language. that think clinical the put boilerplate that the how put that the a the an from patients captures is that endpoint just description

take or I of that think clinical agreeing the still a endpoint hard to eGFR-based So was endpoint. that an were implications they

Annabel Samimy

Okay, going great. see you much. MERLIN remind when just Thank to Can data? we're us you so the

Manmeet Soni

– filing, already already and that our it had It's which we submitted already It's there FDA. Annabel, Manmeet. we morning the submitted in this is XX-K yes, was data already there, this to

Warren Huff

Yes. to Colin, do it? you want describe

Colin Meyer

of The epidemiologies, the Sure. for enrolled with across the with bardoxolone diabetic was do enrolled MERLIN also evenly trial patients type patients, CKD, hypertensive and XX those was ADPKD FALCON for placebo, randomized common qualify to who with approximately others. patients most many

ongoing perspective, we we an additional trial, data used the perspective, trial the progression. across used with eGFR patients Importantly, Alport or patients of at the in And risk entity as all that at actually we through From syndrome showed was well same who Falcon significant our an demonstrated those increase the phenotype multiple ADPKD. titration as CARDINAL from a of rapid time included are points. assessments design treatment

XX trials, seen the acute three, XX, resolution and XX what XX days, with so XX, days. and in see And we've after of consistent within eGFR our we seven, other effect approximately

XX, And slight suggests so day placebo between at XX still by there's but some and a so XX. the longer significant reduction data there's day XX, that numerical and somewhere effect no versus

XX between and the same. group between difference the XX is days XX, Importantly, and placebo at drug

support its frame we've continues drug that on that lose And so does acute to eGFR time case hypothesized. originally that the our effects in fact within the

Annabel Samimy

Thank great. Okay, you.

Operator

The ahead. Brian, next at Brian please question go Skorney comes Baird. from

Brian Skorney

or I Hey, actual have removed and on they good data. FDA with? change period amendment, XX, And that didn't day the and at XX the you couple on mL at treatment for following data when did wondering years. to And XX the my give gave be XX-K, be have XX the and you day X.X about Thanks A of the then accept all major look to to as FALCON, just even the treatment? off-treatment studies said morning also to values protocol XX that just begin refused then questions. this year everyone. they XX for on for off going on you data in been X.X taking Can characterized in accept a for one, the it MERLIN as know the XX, unchanged.

one. patients there's accounted imagine a Thanks. year for final who analysis in XXX So for the I'd XXX? treatment for they weeks may couple have are probably of stopped How four week statistical for

Warren Huff

comment meeting comment and and MERLIN in I'll on study on the the analysis comment question prior the start, finished to about FDA to want again, their last the hand was to FALCON, and values. it the statistical request. XXX with the to amendment I'll Colin question, to question -- a the did the be We'll analysis. A Colin, then in a used -- on with proposed you I'll that start In a there XXX because our be asking and do those? And the design patients for plan that Type to over not MERLIN. they take the have would week you

Colin Meyer

in in [indiscernible], a at our which where more a function couple with slight Yes. over with to see of what months disease We duration of XX. persistent effect kidney on and we've consistent is trials start three XX we seen That's days XX, consistent separation see modifications. some around all of

Phase in Kyowa was difference our TSUBAKI similar a Kirin's trial. seen so And X

our stuck and it disease-modifying is effect. information and then, FDA the MERLIN from far the beginning so resolved from at some And again, shows they once our look there in obviously the that that as considered therefore and as as additional to is the consider they we effect amendment Brian, And a perspective, of it mature acute amendment certainly PDUFA review as so reviewed from to provided date. will, they unsure not as if were was it and we major late did

to from our periods. perspective, future will of be And off-treatment in and those discuss the think I so sufficiency discussions helpful data, the

Brian Skorney

thank Great, you.

Operator

question next go at Joe please Leerink. ahead. comes SVB Schwartz from The Joe,

Unidentified Analyst

my is for for Hi Joe. questions Will you Thank today. all, taking this on

been for kind company thoughts the in when that one wants first on the of the call So since hear And raised terms great that the the laid the to it out us, points it'd since your straightforward of meeting. then sounded FDA this is of interpretation AdCom, see, company's rather this. agency that's some the hosted during what of to be

much AdCom the sounded it different. during However,

on follow-up. So additional any here thoughts one And and would quick I the those have AdCom then appreciated. that discussions be

Warren Huff

that address is I Warren, Yes. this I'll question. really,

briefing we of that very model, its immediately prior on was focused off-treatment really that and the that got, value for their book, book briefing think discussion most to the the and over discussion, that AdCom introduced time that in Thompson and values after separation was a afternoon. the question there little for of at during AdCom Lisa actually I before on the the regarding general off-treatment discussion presentation the the AdCom. FDA's of time issue PK the so and the resolution introduced lack immediately separation, basically our at

briefing in document. addressed wasn't it document our really So their or briefing

I have Kirin why clinical that the Kyowa has the meaningful nephrologists. think the dialysis, view And the theirs, just over the think study long-term I information a why think a And in opening positive it impact very among think the I that's discussion effects was about that if of to would were time. to the could mechanism bardoxolone trajectory so, nephrologists have But improvements. most that the that I honestly, the we have was vote. going gotten on I concern important that that's And potentially the remarks; of of was would very eGFR profile the a the outcome. potential believe assume I of and affected convinced provide And of said acute delay I concern

Unidentified Analyst

markets? AS could for Bard then And in the European status thank That's regulatory great. us helpful, briefly Okay, just you. of in you the remind

Warren Huff

and receiving It's and we're that responding now. in review, -- we're questions active under phase

Unidentified Analyst

Thank you.

Operator

[Operator next Instructions] please question Matt, comes Ladenburg. The Matt from go Kaplan at ahead.

Matthew Kaplan

the morning thanks questions. and for good taking Hi,

protocol in Just AdCom for at given address the recommending? a the can FDA off-treatment be, and guess, the followup in you discussion how the about the the week protocol from wanted terms buy-in should the of I period I in little a be to in that questions FALCON. off-treatment talk guess, that off-treatment of going amendments that incorporating, you first, And bit period the you'll you're to terms you're FDA's of when terms then amendment long do XXX, have think period, to at context previously? of

Colin Meyer

We've Sure. I'll actually requested take these. a A meeting. Type

Matthew Kaplan

Recently?

Colin Meyer

recently. so Yes,

we're But also with incorporating believe a moved hoping So so feedback is collection or that. it the those period, we're off-treatment primary questions, analysis With and we XXX, week extend do to And PK/PD division. point which XX-week consistent endpoint they the obviously to hoping to obviously so. that's want of a if within we're need XX XX-day the meaningful the respect clock we one of that's days longer? of for to have we the like

so And their we think XXX them. PK/PD the with but consistent is analysis, specifically we're again, asking

Matthew Kaplan

Great, and then increase lastly, FALCON? to guess in readout sample the given I size a you potential XXX, from anticipate do when

Warren Huff

provide not until FDA. feedback we from get ready the to that guidance some on we're really I any think

Matthew Kaplan

All for questions. the good. thanks Sounds taking right,

Warren Huff

Sure.

Operator

on I'm Again, you. today's queue. for the participation your questions showing conference Thank in call. further thanks no

at reatapharma.com an section. your available As on you recording reminder, much shortly Thank in after call will a for the audio the of Investors Reata's call very the participation. website be

may now disconnect. You

Reata Pharmaceuticals (RETA) 28 Feb 222021 Q4 Earnings call transcript