RETA - Earnings call transcript Q2 2022 | Reata Pharmaceuticals Inc

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Operator

Thank you for standing by and welcome to Reata Pharmaceuticals Second Quarter 2022 Financial Results and Update on Development Programs Conference Call. 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. Reata's are earnings comparable today, release can found measures in financial which financial be Reata's the and in non-GAAP reconciled GAAP with measures again These website. presentation from of Today's statements outcomes. future are guarantees not Please no apply August as call on re-reading. only replay accurate be that at also and of of may or any any webcast note XXXX, made today's comments X, longer today, the time transcript

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

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

Warren Huff

I'll quarterly everyone. Slide X. morning for today Good our thank us We start on joining for update. you

molecule in dependent Omav, approximately and debilitating walkers As you or approved progressive is relentlessly therapies know, which small Friedreich's a with of become FA. we're for or are FA X,XXX and ataxia, United neuromuscular no the in developing a patients treatment patients unfortunately typically then their patients There and pass-away and mid-XXs. the States. their wheelchairs the from NrfX affects in omaveloxolone, mid-XXs disorder, activator on disease

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framework the by Omav slide. trials substantial NDA well two generally some requires and on evidence, provide a which that review. for for established the background FDA effectiveness to drug at now I'd a like drug's least be approval. Next controlled must adequate regulatory guidance clinical new states

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mFARS has As X. from MOXIe I FDA results Part not expressed mentioned about earlier, the of the primary reliability concerns

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results the Manmeet our Lastly, financial will quarter. for Soni review

Colin Meyer

Thank you, I'll Warren. start on XX. Slide

submitted update we FDA start As a year. analysis of the recently an from Warren March to in the data delayed this to cutoff mentioned,

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Next slide.

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Next slide.

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fibroblast. has on Slide on in FA to XX shown NrfX restore levels shown patient the Omav been left, As

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with provides sections has patients slide. placebo data. Extension, missing Part efficacy supporting evidence our analysis March serious To have match to mFARS mechanistic All patients MOXIe patients treated of Omav. compared incidence pathophysiology patients These and favored with of propensity from low amount MOXIe directly Omav Omav with adverse affects the tolerated Next significant P events. X, FA-COMS with results the of low of a compared major mFARS demonstrated with matched the In MOXIe provided perspective, and sub multiple supplement a NDA data X and for analysis efficacy X.XXX. to start safety a and summary, value in in of From subgroups submissions additional XXXX, of submission been with a how treated improvement the FDA include we Part primary data delayed showing of the with evidence of a Omav FA. well underlying the through Omav,

the we FA is observed cardiovascular over fewer discuss findings evidence pressure, identified the in ongoing or no MOXIe ECGs X. disease that, new With cardiovascular no of advisory blood pieces upcoming these on in We and commercial ECHOs of safety we While study. committee our Dawn I'll findings any increase AEs, in plan common our meeting. Extension an to on preparations. have all patients, serial turn in in call to not Part for Further, update

Dawn Bir

you, everyone. Thank Colin. morning, Slide Good I'll continue on XX.

Our launch preparation continues in step with our regulatory progress.

that approved this treatment November the with of we making every of devastating XXXX. commercially aware market no XX, operationally early we that ensure are to and is our date effort in to launch are PDUFA approach As we prepared disease

and FA patient through educational FA variety patient engaged community and advocacy we've research, the years, connectfa.com, of supports resources. disease website education our For with patient market a focused which tools events,

quarter, and genetic launched and treatment. education testing, focused FA disease the urgency we and disease ThinkFA.com website, our need severity During second recognition, HCP of for focused the diagnosis underscoring progression on management the

search We advertisement, Friedreich's website campaign, digital patients. marketing traffic marketing, drive ataxia a an that tailored treating currently to to and also leverages all reach deployed banner to engine campaign e-mail the

and saw XX% targeting first of more month identified the efforts, HCPs a level treating interest than with our U.S. website active over high disease. X,XXX of visitors in of ThinkFA.com list in being the this from promotion, assay, digital our physicians treating During indicating accuracy

initiate from start compliantly and programs offer pocket to healthcare orders a access of sales of rare limited patient with projects key supporting sales channel the We complete access distribution Manmeet, pharmacy burden alleviate will to and to I'll omaveloxolone focused include to hiring QX patient engagements the we've prepare providers, the to new over now also sizing product advanced the initiated Patient plan Thank and turn regulatory process, also of and the will to designed includes disease specialty call initiated program of operational of force. investigation first Reata the REACH benefits designed who success. of reimbursement. team patient payer our The intake neurology in the Furthermore, launch. you. We It specifically support QX for launch our needs financial services the update. a design out front-end cost. to provide

Manmeet Soni

XX-Q We quarter. highlight like our items Dawn, Thank few earlier our financial for a released morning. would and filed financials to you, morning, and good everyone. this I this

Our consistency compared our and deferred in the strong position, prior quarter, expenses as cash operating revenue. collaboration to

our Let on cash balance with me XX. Slide start

of solid equivalents, in and balance cash $XXX through As end million balance current enable operations our with approximately XX, securities. maintained on to will plan, marketable us June our cash we Based fund debt of sheet a the cash, XXXX.

to Moving expenses expenses, operating as to the first compared GAAP remained quarter non-GAAP and both consistent XXXX. of our

of milestones the the we all under the Kyowa second of Agreement. Lastly, earlier revenues Kirin as the related deferred XXXX, end to of quarter of have achieved recognized

future collaboration to will of are recognize a we quarter second the revenues deferred milestone subsequent earned. As or any result, not revenue XXXX until

of the for drug launch next With continue progress turn we Warren. Omav over will front, that, the On year. the on FA commercial back operations the early supply to I commercial for to call anticipated

Warren Huff

analyses during closing, information believe submission additional and our In Manmeet. the evidence program, of we Omav in the NDA including substantial the to for progress demonstrating strengthen body our Omav acceptance quarter you, and the FA. FDA, effectiveness of Thank the which of and we've made

to our prepared committee to it be everyone If prepare this disease to next meeting continue we're the early year. on severe discuss actively in for turn We'd operator drug launch concludes first advisory to who commercial available opportunity the with be a to our the for for We the approved, year. thank That in later preparations position and application will questions. to dialed working the and upcoming remarks. I'll over like and this the call Omav committee now

Operator

today you. Nochomovitz go Thank Yigal, first comes Citigroup. from [Operator question please ahead. Instructions] Yigal Our of

Your open. line is

Yigal Nochomovitz

and Hi. team. Warren Thanks,

AdCom? Omav yet received so, you. think date which question, operational one if a you the are have And first disclose you of wondering Just people Thank now? I about, that a can lot for

Warren Huff

Thanks, Yes. Yigal.

date We're the makes not a public disclosing disclosure. disclose is AdCom, until it tentative There a we're have date. actually the for able to the from it. prevented We but FDA

Yigal Nochomovitz

regarding more it. bit a got strength to And of down the then the Okay, wanted FDA the concerns efficacy evidence. drill the little I commentary on on just

made So, and more X.XXX on discussion you might the the And when population a pes the where was specifically cycle, FDA the all Thanks. P included comment comment any value, higher a there the strength this concerns of population was about primary comment, were analysis preliminary cavus for randomized value focus pes for there was in the cavus? this P mid that the the non- cavus? as or evidence, know, about non-pes lower on the the X.XXX on label

Colin Meyer

Colin. is This Yigal. Hey,

of with X.XXX. believe XX so, strength a And P to not evidence of concern raised we the contribute the value FDA cavus. with – the is about that difference the comment the upon about which the The pes a was X.X patients patients primary of based efficacy has results, between the

I think approval single in is single the other a Warren to study lower. context any as typically study evidence of earlier, support typically approval, discussed a value for the without P importantly,

said a and this this as FDA we new And not recently told issue. today, so, is us call that on

And rare study. the been so, concern a disease the It's has the single with trials of for concern. strength the evidence typically

been FDA provide couple persuasiveness. And years in so, with a with of of them we additional dialogue we've and since ago a really to engaged met evidence

communication meeting that mid-cycle they recent restated concern. the so And

this on could call we had by we Q, address and submissions. and those a they the concerns in discussion so that providing additional disclosed we dialogue specific engaged As in points

down in and study confirmatory going concerns with specific said approval not FDA of had been path that they've single about evidence so the has X. simply we've And Part conclusion, MOXIe

Yigal Nochomovitz

Okay. And then just delayed one follow-up start. on quick

March in did you So, was have data any noted, points it not sampling any time sounds where the particular on Thank points? week-XX at lower your XXXX more that the was distilled the much initial data you better the raised at cut there on you. had focused detail the thoughts at more provide mid-cycle? on or sampling they the And updated the the outer that of as delayed from convergence start curves commentary the like time at FDA was

Warren Huff

question get the discussion a we specific of week-XX extension. which did of at wasn't We that, there earlier Yes, the convergence about addressed.

end. – that So, end] sure dropouts. [ph] there we a [reduced not not just was that were it And study the I'm general reduced that they was clear statement were

couldn't closed to it, So, be this about come had the in most done patients during patients COVID-XX clear just clinic of course so and of so this mFARS in. was period back and during clinics to have and were assessments

stayed the were impact particularly in as waned, time but that point, missing week-XX they values, the back the came pandemic of patients those they in clinic. So, study, the XX to at

data time the And so at the filled points. in later

acknowledged so, to it, absolutely they showed yes, and and said it. And they and submit that asked submit we we it them data

Colin Meyer

other are to recognized think and pandemic that point wasn't comments division. fewer the make just Warren's one patients, initially follow-up I the hit because that is to there on And by COVID-XX clearly because and

to low-end And could so, dropouts. be they had wondered due the if

the in so, And to has restarted also addition clarified the coming we that have patients to clinic, dropout been that rate low. clarifying

And X Part years completed that ago. MOXIe so, was X.X about recall

And all remain. the time, years. patients the so patients And X.X for enrolled this point XX% still been in extension who least in the approximately in have extension at of at

the dropout And a so years, low pandemic. during there's been rate over very three including

Warren Huff

good later accumulation the at of a And data time points. additional

Yigal Nochomovitz

Great. Thanks much. so

Operator

you. Thank

from please Our Sachs. next question go comes Madhu ahead. of Kumar Madhu, Goldman

open. line is Your

Madhu Kumar

questions. our guys. Hi, taking Thanks for

patients. reduction So, on the number of point this around

in that I specifically specifically, were time feel who patients to and data XXX? to I show any of kind guess I missing that way week-XX XX the back came let's to of updated speak there is like mean, patients interestingly, question So, pretty like the weeks say, and does the is, week-XX over show, overlap

Warren Huff

is the we've that rates same. of conducting addressed two the an those way subgroups the best determining basically that analysis in And The that are slopes demonstrated we've by progression. of

P than [X.XX] there's And difference. is no and value so, [ph] greater the

and all at And that the same rate. the they're patients progressing that estimates longitudinally shows over that so treatment time includes effect that

the that's And really so, best way to address it.

analyses We those updated and the to similar what to have FDA. in conducted have you described our other provided sensitivity report

Madhu Kumar

I on it, secondary of kind you a [ph] further of first provide separate [weak kind from endpoints, around support] from can of secondary Yes. analysis the there endpoint the question any that is guess the employers?

Warren Huff

over it's FDA's important no they've support there's that no there as had and saying to from secondaries disclosed two years actually note the think support. I was ago changed view that that weak we to their language

And recall at with data that some so, questions with favoring favored Omav ADL weak that are support. that the P there a we them all X.XX of we've that value Omav. provided have believe And nominally least to see allowed nine

secondary was and first randomized to Omav. CGIC the population. of favored rest The and PGIC nominally close actually Omav trended favored was the majority them, in was all significant and significant the

we generally in notes so the secondaries, And FDA believe which there reason that now a consistency support. there's the why was is weak

Madhu Kumar

Alright, thanks so much.

Operator

And ahead. the of to Duncan Charles next go question Thank you. please Cantor Fitzgerald. goes Charles,

Your line is open.

Charles Duncan

of in Good the Yes. result or event? QX information thorough an major a do PDUFA push date, that Warren question with provide I a in but wondering I Thanks, if this to or that all you've amendment? an and be could not submitted that for little wondering additional a analysis. guess or color one, a considered done. morning. could also luck the more would I'm AdCom earlier And Good sense could be whether you QX terms team appreciate you a it work then

Warren Huff

of submit a that like amended encouraged get you They it like us They date. Okay. PDUFA to indicated data FDA, I'll in take not this, quickly there would extension. PDUFA invited because have rare particularly be NDA. in as your deadly respect to first diseases question, the know the data the the us Charles. They to

date of under as to are, provided the given that it, weeks make haven't AdCom this from looking it's yet us they at they until disclosing for us with rules date point. date, from to before tentative But six themselves. decision course, date a the respect make a so, date. but With the simply public of at they to normally probably can [indiscernible] they've time And projects, the know, the prevented we're any extend FDA at any eight you PDUFA other indication

Charles Duncan

sense. Makes Yes.

going compelling, question but I'm is of and information you not what the to relative FDA think most of I Second guess, find work pieces ask three here. done to being you lot will if mechanistic you choose which would information? or or match that to be it Would data additional had top the find delayed sets Why? the most propensity the your be? it start you compelling,

Warren Huff

are in think important different the well questions. clinical both slightly and address the delayed data, extremely opinion analysis, compelling. with I start the starting as my analysis Well, matched as propensity They

perspective XXX a analyses match it the where in matched over years almost We very analysis than the at intervening disease three clinical the greater trial. participated set therapy, provides patients no an a rigorously there's of sensitivity history long-term and in the the of is consistently, progression. a same many with propensity additional data rate – of reduction we study showing patients that the sites benefit a multiple done of well So, a natural done been have a and in XX%

of disease. it to not want of So, for a only make to And it course study. evidence under documents, I the to be, natural that has second for standards The the a equal standard has the study. basically provide it is controlled controlled approaches clear, guidance the that

at extension indicating progression of strong controlled the it's analysis of And effects you Extension at the the the FDA's the at data disease the addition that And the and maintained. rate disease. And and continue The a has so, of in that like clinical a the randomized observed which delayed preliminary during this think clear provide modification the for there's of example, modified. is start I space, disease course design of for the in of the separate the slowed. the XXX-weeks it's impact Alzheimer's at now some did start very guidance, in the study, the evidence addresses that extremely question, that was showing in other a it portion week-XX best to if words, benefit of week-XXX course data In difference progression? out one-year look end of large amount long-term is

for the of impact think all for And in a XXX, FDAMA the basis very strong the work well. a as confirmatory And of under data clear of and of so, because I mechanism as basic well. disease, finally, providing evidence done NrfX support very is confirmatory around important the it's that's rationale action

Charles Duncan

the Last from the FA-COMS members question. added composition, Relative you would those panel, neurology of the investigator the know, of so terms that would of come folks Very to panel, in quick the anticipate good. group? AdCom you any

Warren Huff

and understanding unclear be who don't It's will have of an panel. we on the

And who so, will have to we'll those members be. see

Charles Duncan

the color. Thanks for Okay. added

Warren Huff

actually point I credibility investigators to same. many of mean the clinical in though, and the practice lends that one because site – the analysis to investigators obviously side the slight is just FA-COMS make were matching the

Charles Duncan

Got it. Thanks, Warren.

Operator

you. Thank

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

now is open. line Your

Annabel Samimy

Hi, taking for my question. thanks

really mention reviewing So, you did the but is on touch that the much, cardiac FDA still you this didn't issue. safety

how a I of we've validation. that is was, of mechanistic and this remind [MOA needed an explanation my you can little FDA provided that NrfX provided cardiac package, given why a understood the very is evidence then in they And have study. we've you from what been of bardoxolone, much a so issue lot could data] mechanistic any? precise doesn't guess Do had further So. you question you concerns additional criteria omaveloxolone what part for pathway? address you that came up before the and validation there sense time you in this here if me saying have? exclusion here original pathway some some there time of [ph]? BNP disease that just there monitoring? analog just the an the obviously, was provided this wasn't that the So, have of now, appear for because follow-up the do So, safety would could It you and I that

Warren Huff

Sure.

the concerns. regards specifics provide any not did any to they in safety, first, about So cardiac

common no trial, There safety. we've on that. were And was are did and we broad importantly, In events these long you potential our as none. FA enroll, patients of blood as there signals cardiac cardiovascular were As the said, mile cardiac And findings We any patients. a look have to search again, to at once ECHOs. pressure know, had disease. to serial cardiomyopathy, or unchanged allow adverse fewer they arrhythmias because and patients arrhythmias SMQ in for these in saw characterized I we often ECGs extensively as moderate

regards at and the In is so, we they we underlying the provided the specific efficacy. point, their reason don't in context have why we to And MOA, obviously data all data to comment know them. our concerns provided this any additional of if of about

submissions Any approval. so, could through that to of be them three evidence walk different And support one we've confirmatory we made. sufficient and could constitute

it's but data the demonstrating NrfX. NrfX in so, to importantly, trial set that a [ph] been that numerous the NFA, publications only exploring suppressed FDA, There's to [has] now And wanted robust that we we've show benefit. clinical NrfX thing induction we've past our that's in able not associated emerged clinical of to is role and year, provide more one that been recently of with

since submitted very a that's a that so link that been mechanistic FDA. has finding newer to And is strong

Annabel Samimy

Great. Thank you.

Operator

Thank you.

go Our goes next of ahead. Jefferies. please question Maury, Maury Raycroft to

line open. Your is

Maury Raycroft

and taking was data. my going on one I ask questions. Hi, thanks morning history the for to natural good

levels points, mentioned FA you You about by match match of protection the characteristics baseline living? five patient up or different up daily that GAA can baseline talk repeats a patients how the activities the on well

Warren Huff

Yes.

drug And and difference them so, same. characteristics demographics most is GAAX similar, are broadly biased repeat the the the baseline one against The of almost that's numerically actually are length.

the versus And extension. numerically the so, patients longer it's in bit treated a little Omav

the plus we they're other difference, XX% similar. affect of would And so, in analysis, all greater of obviously than but make if saw that reduction the that results, effect the one smaller, very rate than treatment but regardless, progression were across a our it to

Maury Raycroft

it. Got

has data, GGT and you have action? on is And provide you on relationship or remind then can in the the biomarkers whether protection, the biomarker of and commentary any data between you biomarkers specific that per preference the biomarker slides assays Okay. for FDA what can Barrington mechanism for and

Warren Huff

is So, pathophysiology that the has be guidance well understood. FDA's to underlying

the is research XX% of of demonstrating reduction have They activity literature And a for there's that frataxin patients. couple FA due to decades and in worth in so, of mutation frataxin. positive and less

mutations. other point have the X% they For

understood of is has so, And NrfX. that What tax deficiency with understood. to well in is that years is well not mechanism few emerged past some suppression associated for and the that's

of so, simply said the you take in frataxin [ph] administer on And reduce directly. suppression [siRNA] NrfX in that I call, to as frataxin if it cells, and results against

NrfX, production so, factor target them. recall, genes a you transcription two as of And that many controls of ferritin and are the is GGT and

benefit standard And GGT And can Omav so, panel. found the we've of your chemistry dependently publications production those those and shown parameters clinical of clinically using on is two are increase dose that numerous that ferritin.

time every at And And a much draw were so, benefit see for We earlier, by I Part in we as week-XX them as pretty at, assess I treatment changes to look point increases week maximum NrfX can where we said, basically four. associated blood with X, the patients. activation. clinical after MOXIe showed, is

very And clinical so, a story with our benefit. drug's whole past has over and NrfX and to restore there's suppression, I between ability pathophysiology that emerged the think few frataxin strong the years now associated link now have efficiency, NrfX underlying be and

Maury Raycroft

it. Got

Thank very much. Okay. you

Operator

you. Thank

ahead. comes next go from Joe, Schwartz Our question Joe SVB of Securities. please

is line Your open.

Unidentified Analyst

today. Hi, Joe. our all. on for questions This taking Will you Thank for is

us. have one FDA, the some several reviews. seen at So, neurology we have over profile division the members of for opinions different at leadership senior high Recently, the team

more here favor many And be in regarding insight Omav? how any differences are So, are in have versus you. you are some do wide there you sensing helpful? critical Any would Thank insight that opinion Omav? into people

Warren Huff

into the at the FDA. don't internal no think discussion – have we Yes, I visibility

And the inside if so, at of what people could view in might senior really differences – the the review FDA be we no team couldn't have there comment we view or any?

Colin Meyer

have in say have they very meetings, range participants I of wide and And been will we transparent that, and our with us. open a had

because part concerns review the we've the address any of been supplement able coming As senior or said, transparency, that to NDA. any of just team Warren from members

Unidentified Analyst

you. Okay. Thank

Operator

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

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

disconnect. now may You

Reata Pharmaceuticals (RETA) 8 Aug 222022 Q2 Earnings call transcript