RETA - Earnings call transcript Q2 2018 | Reata Pharmaceuticals Inc

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Operator

Good day, ladies and gentlemen, and welcome to Reata Management Call to Discuss Second Quarter Financial Results and an Update on Development Programs. [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, included those noted in the Company's SEC filings. Today’s statements are not guarantees of future outcomes. time any today, on may August be at that only call no note replay accurate of webcast as X, the also comments rereading. today's made speak longer or Please transcript any of XXXX, and today’s at And website available shortly on in the Investor will after audio webcast be call the recording today section. of reatapharma.com Reata’s and News

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

Vinny Jindal

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

Warren Huff

call. you Good and Vinny. everyone, our joining thank afternoon, for us quarterly Thanks, for

programs of As drivers of kidney most for fibrosis function where Alport disease X/X know, and forms patients in developing of study. kidney syndrome CARDINAL key the Phase are loss severe failure, bardoxolone of you we treatment chronic rare in and lead are and renal are our kidney inflammation

nephropathy, as by function year actively underscores on that to from of we were diabetes. portion demonstrated data data benefit that of prevent portion to CKD, long-term of is these to produced the statistically of syndrome Furthermore, patients. standard in the one the Data placebo, have patients cohort kidney improvements significant the July, an FSGS, ADPKD bardoxolone patients powered in well Additionally, retained IgA this from full a data show eGFR is delay care. point improvements CARDINAL trial, Phase in of PHOENIX significant kidney Alport trial. the we’re bardoxolone who CARDINAL conservatively while also function X retained forms in improvement four as potential Phase suggest with announced dialysis by declining the additional that Phase FDA. the open in for the or benefit compared observed X CARDINAL, label ADPKD, caused In rare type CKD These and approval the enrolling for trial, PHOENIX key X conducting including X the EGFR which by endpoint produced study

topline We available X the portion continue half be in to to second of of expect the CARDINAL Phase XXXX. data from

that patients of after in During CKD with In in weeks July, diabetic long-term from improvements bardoxolone we bardoxolone. ADPKD also XX trial our treatment for improvements syndrome, eGFR baseline correlated improvements. significant now and kidney function Alport experienced announced eGFR PHOENIX with treatment XX-week

light to In other bardoxolone As respect of ADPKD. improvements a in this pivotal studies, that translate other improvements plans ADPKD forms eGFR clinical suggest CKD to we’re into EGFR to we our the With long-term type these finding, developing the ADPKD. may to of patients observed the observed completed a be quarter X cohorts expect full program patients advance cohorts CKD in result, this in endpoint during XX-week in with IgA available are third to expected in And half XXXX. of second first the in endpoint the from primary from the we PHOENIX quarter. FSGS and year. enrollment available the of Full nephropathy diabetic primary CKD cohort be data of data

program. registrational Turning to second our

in topline planned the the pivotal design will activator part pivotal and in data of the FA. is the observed results Friedreich's MOXIe second of for ataxia. to the therapy treatment study our generation MOXIe We’re two part pivotal one second trial the as The to first of expect approved be MOXIe the available NrfX studying with from year. and an proceeding omaveloxolone, ongoing omav on we optimistic study for of become that in patients Based of next half MOXIe, we’re continue

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

Jason Wilson

Thanks, Warren.

this earlier, mentioned As results the afternoon, second financial XXXX. we for quarter of reported

loss $XX.X net the a $XX.X or or last share, per per quarter was increased for The for million same loss loss compared net net period driven is the primarily $X.XX factors. Our $X.XX four quarter of the share year. three-month million, for to by

was revenue to in license revenue due there the a to a a being recognized agreement revenue, related fully decrease in On previously side, deferred XXXX.

Warren. Japanese capital related that, expense. expenses agreement, our and closed receivable in to increase cash and equity current fund XXXX. the cash manufacturing milestone to fees, June and requirements research million net well. our XX, also Based we administrative of an in as due of that extinguishment which to saw and In an over we the debt expected And and quarter we change with the we milestone expenses an we from proceeds on increased XXXX, turn side, expense call back partner, of will I we $XXX quarter, approximately clinical recorded, $XXX related under we to into sufficient believe had recorded million. And our At in be specifically KHK, and course, equivalents this that operating payment activities. expenses in expenditure offering debt to to the the cash, this July, our cash. with our little general had a and And On development G&A will

Warren Huff

Jason. At for is for parameters, pivotal therapeutics of We Reata, small orphan with X battery we action set has looking the This severe effective for high and approach X registrational novel syndrome, molecule conduct provide Thanks, diseases study, a studies in develop our PKD produced that and programs opportunities that mission improvements therapies. Phase in of expansion clinical concept and Phase studies. studies to of mechanisms program bar pivotal no pipeline X our promising in meaningful and of programs a advancing of to Phase transitioning series therapeutic of our diseases. areas a current Friedreich's CTD-PAH, Alport a key a ataxia in fourth in three neurodegenerative is nephropathy proof with additional

turn diabetic of IgA Phase programs, the full a With orphan sheet results one course first results of more Friedreich's registrational second next and X from PHOENIX commercialize the therapies the studies from nephropathy, balance X or full groundbreaking That look And positive on type and the of our to months, of the data the call now questions. line to ataxia for concludes to in pivotal produce strong our Company soon the of ongoing years. from this in the cohorts data the updating Over FSGS pivotal half our in PHOENIX coming half We and we portfolio XX diseases expect forward top the Alport for including remarks. trial cohort quarter, the is well-positioned XXXX, prepared generate of flow XXXX. to news CKD a I’ll in progress. underserved over the operator significant the syndrome you and

Operator

Instructions] Maurice Jefferies. [Operator first Raycroft you. Thank comes question Our from with

Your line is now open.

Maurice Raycroft

FSGS diseases with males found I in talk between I'm kidney different also females, influence if And bardoxolone. these question trying -- are and just pursuing you about may pin of mutations My in kidney rare in of you're out the prevalence? types Alport first IV is could spectrum differences and collagen wondering too. how any mutations to the which thoughts disease and on syndrome believe

Colin Meyer

Colin. It’s

much both is known be syndrome so type some, males Alport just that more occur there different the progression. in and defines mutations yes, that spectrum So, Alport that What's a by patterns, females. collagen are several and likely of IV rate of females inheritance as males. is syndrome of to disease. though, male-only There’re now thought is in Even just affected than that and result

may so, disease in end-stage And be males their males a by XX. with affected life, of -- are the earlier X-linked age reach mean disease

their at with in X-linked still with reach with their males disease obviously is than common the females, timeframe. are Females reach XXs. to actually males and X-linked disease, equally a more they affects and autosomal Importantly, tend similar ESRD it life. patients recessive which But, in disease

estimate Foundation we that as that third And Alport have thin the Alport patients of patients number patients of to syndrome as actually Alport Foundation have with XX,XXX with Syndrome there's syndrome opinion many basal recently of there of have so membrane disease. believes but are far FSGS leaders up the large -- are published set Furthermore, key a syndrome. that misdiagnosed patients likely XX,XXX The U.S. the who Alport syndrome and fairly Alport a Syndrome to who have that so in Alport perhaps having as

substantial trying may numbers. big -- explore increase that would now be. we’re population that figure to And But, so, the to potential that a how out that's right provide in

Maurice Raycroft

these how they patients influence could trial the on Helpful. And that included are in thoughts current Phase an any be and guess, design? into I FSGS trial? X, could

Colin Meyer

trial. collagen patients type allowed IV have if are a they mutation, So, in our

disease to And IV have so, as they’re allowed been they’re such have mutation, else, if a thin FSGS, something having trial. if our in genotype basal their membrane type found as collage misdiagnosed or

does trial patients. our So, those contemplate

who with syndrome a Alport to like had not an but may urine suspected we did blood oftentimes a workup. is have recently young common, who the investigate male so, patients top looks campaign Alport there enrolling with our of sites have genetic several in and syndrome, just the patient And

patients XX,XXX exploring I so, patients in be a we’re those meaningful may that estimate figure to the numbers the XX,XXX to it’s in how U.S. suggests, but common mentioned, increase And out

Operator

Thank you.

Our with next question Stifel. comes Walsh from Adam

now open. Your line is

Adam Walsh

Is guidelines these Colin, basement question for Just That’s order some Alport the the reclassify In collagen pathology. to these point? been in reclassification reclassified basement be trying this or of thin some kind now, really this obviously disorders, talk about syndrome the could reclassification size greatly a as meaningful conversations of push follow-up this KOLs terms of There's in potential diagnostic or moment that KOLs is Alport. market. ago. is membrane expands a that as there looking the just obviously patients to just at that at thin or Alport to potentially amongst get amongst talk Maurice’s push just done right very in

Colin Meyer

are they suggesting is KOLs. more important One formal the to are actually -- these syndrome. the membrane is fact a but in say conversations It’s But finding diagnosed now molecular histological that there you Alport many need There patients collagen populations. and guidelines proteins basis simply barrier have kidney. filtration think mutations of patients set also differentiate reclassification, would clearly disease. collagen type order a really not in in therefore with a a in in is patients It’s that diagnosis a mutations two is integrity, that IV of on patient I basically correctly have I type where than diagnose of have distinct a basement appears and IV clinical And not actually patients. some there academic There the these tools those do who second diagnosis, be it’s syndrome. genotyping the to other amongst that just have to are community patients are between for Alport who proper

suggestion That’s classified and mutations work these part type so, to IV upon the some some those formally collagen, appears Alport because patients simply be probably be of And a component. that it having But, the should more determine correctly. prevalence there syndrome. I patients be much smaller to we aren't in think is common, based and as diagnosed

Adam Walsh

ADPKD X you get design could if have of on launch? for of kind that. if And we more just the granularity, any Thanks timing trial duration it, and Phase then,

Warren Huff

we planning move program to when trial. recently, the So, a actively into mentioned, data X we’re I we think as PHOENIX announced pivotal that Phase

cohorts, next from quarter. few data we’re so, the nephropathy and undergoing I of the X in And have PHOENIX the we’ll right and CKD we’ve this And now. consideration as think an the IgA cohorts provide rest stated, important process We’ll data diabetic the type months. from is formal guidance

And so, and guidance little more we I those think to plan. we’ll once more a bit data have have time have

Operator

Thank you.

Our Yigal next Nochomovitz Citigroup. question comes with from

now Your line is open.

Yigal Nochomovitz

you’re would Phase familiar volume. just endpoints to surrogate some which you I if target something sort design am that I to that's Recently, approval. one and kidney the FDA those accelerated with, issued consider in of related get potentially had was for to wondering documents your am sure ADPKD, X of

Colin Meyer

surrogate. also But approval. for has that take So, endpoint Yigal, could an they’ll already FDA as a be, said eGFR full that

And so, the the Otsuka's was this in approved for from U.S. company That which year. conducted an tolvaptan in X only approved two precedent Phase product April is of trials.

trial, the full for That’s registration volume syndrome FDA and endpoint as approval endpoint we and in a full then not total in kidney X:X for for duration the primary in data actually two-week given gave accept second years. first that one CARDINAL and that off FDA had endpoint a at for the same was approval. the And the trial, trial. The approval year did treatment had company eGFR U.S. Alport for they the required two months assessment conduct XX accelerated TEMPO that trial were us REPRISE trial that the

for based the surrogate to of a so, we much upon kidney difference of surrogate. volume And the show more total assumption, it. And is a think already that us, seen really, it’s eGFR. powering a We’ve easier in

And and important more much U.S. so, clearly I are are to the here especially eGFR think data regulators, strong the in

Yigal Nochomovitz

setting biology what the better that on anything you’ve that in benefit you the Alport would in observe there that is would just retained or suggest study? to that And than related either worse might different, shown be ADPKD the

Colin Meyer

No.

literature simply important stronger the similar. role a versus syndrome… there’s is at that think the inflammation reasons Alport be you think, if demonstrating to in inflammation we one, PKD actually I and data in there’s look suggest of syndrome, few why it’d PKD, Number Alport in

Warren Huff

in activity. And which particular the bardoxolone by Rel/NF-kappaB, suppressed is

Colin Meyer

Yes.

pharmacology biology PKD, clinical then and is the stronger, So, furthermore data. the and actually just

as well in as terms And with kidney similar relative improvements to the as so, that in interim we’ve are data. absolute IgA data acute PKD syndrome the patients function we clearly as well diabetic and that in see magnitude Alport generated

likely And similar so, it’s that a we fact. we’d see that think

registration from design so, CARDINAL. for it's like should the they Number FDA And for they have for be our tolvaptan, for perspective a us two required gave design and that’s design because reasons. CARDINAL that palatable to one,

Yigal Nochomovitz

questions on much of regarding of just size in themes going you’re some And and that’s pressing much, then, bigger such earlier the than one into the the as from the any Alport, markets obviously the diabetes, of done is that X type that maybe is your is plan And that you in but going those of or haven't long-range on something because CKD. setting, that there? pricing dynamic you’re

Warren Huff

were It's This drug is prior effects a obviously validating indication. quite the Warren. target studies that I'll population. two of of address patient that. terms the The in

as a guidelines Kyowa partner, in Japan type study validated and they’ve study standardized X course, our or the conducting newly is Hakko you and CKD, Kirin in registrational adopted diabetic know, Phase for trials. Of margin in that X

outside of study would by that the be adopted and by the FDA So, Europe. that data from likely Japan, have would endpoints both

to some the we for represent renal the diseases broader launch then, induced through execute for whether point, it work which this significant that of a point, going And diabetic matter these makes sense at product CKD opportunity. our rare market product even disease, develop into and products for will these or the plan forms the collectively decide to markets, type example, X so, for CKD. And very hypertension we're rare at to

Operator

Schwartz Joseph with from Leerink Our comes next question Partners.

now Your line open. is

Joseph Schwartz

and you pursue? questions. and much then, expect many do Couple a lot for the of clinical your Phase hear how of programs financial bardoxolone, kidney expect each -- you How We to a X would first question. cost,

Jason Wilson

can disease but and efficient. trials are These the trial say haven't patient the small designs. come on efficient that extremely they populations and rare given of cost ever really are We with I cost specific trials, guidance

of something in. many terms pursue, data come we In how as that’s announcing we for the might the that would trials be various

Warren Huff

per Right. of and go will we visits on next the the now chemistry is guidance in and comment. the planning endpoints. based in there Jason's basis, But, ADPKD, much late expensive for just a as have timing after It’s example, on year, we pretty routine involved the get after will add clinical to have opportunity trial or we’re These interactions. are not we through a said, studies. study expensive an patient regulatory I and we -- clinical imaging, complicated pursue year not to this to that give

So, they are really just driven numbers they’re by and impact. large the not a

Joseph Schwartz

And realm and size do together, how get outside orphans? across then, which think pricing you them large different about when you the so of add many quite markets,

Warren Huff

Sure.

Of additional course, least the one forms -- forms. is group. rare the the Alport most syndrome also prevalent the severe we’re that conducting the five of the CKD out of It’s probably in, of rare programs lead five of the

if would approximately forms, probably So, and that prevalence at doing, were were price. support the other end the in we patients spectrum, of among XXX,XXX, the obviously, a XXX,XXX of probably U.S. the the only thing that XXX,XXX PKD population rare diagnosed it highest with of

I of us by And modifying the syndrome by can disease Alport reflect would think add, about would for given so pricing for -- the FDA range activity. so way, endpoints you the

in Alport, no there’s approved therapy so, is deadly and And it disease. a

rare in modifying imagine therapy you then, have for consistent So, over would as the line time, would expect approved can expand be I the in with we with disease. the expanded pricing label, disease deadly activity the pricing And fall opportunities. a frankly, first

Joseph Schwartz

decline And then, does linearly? GFR progress or

Warren Huff

PKD thing, priced may by a of U.S. just the for is you way, kind aware, the They in or benchmark. not just And be at last it annually may one the one tolvaptan $XXX,XXX

Joseph Schwartz

fall patients is such off from necessary? responder you you're GFR that is, that analysis? to linearly which to Like does all is a certain it below point or a prevent thresholds, as dialysis indicates a cliff? diseases is declining just able or clinically, just there one show can throughout last And these My accelerate decline tends where

Colin Meyer

loss extreme o released these studies in minutes X patient's are very already course not across and the We’ve off annual PKD, X it's It average. for life. they those for to of IgA forms trial, X have fairly patients life. function are still have and years per in three then data typically there’re to fairly prior In usually is range of that between stable first exactly say it’s kidney their showing X. minute between to They And prior in the of or we not entering X.X X slightly fairly syndrome, often in there's PKD. very year. start was but to the patients decades amounts lose period different like typically a rates then linear lower on X And primarily. different for per prior progression. Alport And it’s early that per type X decline. X probably linear So, X, CKD, function, to perhaps X.X. to I’d of ml of the to PHOENIX losing studying fairly kidney fall we’re Those short entry a a ml meaningful. two In And X, This in is cliff trial time. of be shown expect the linear

upon on any And in XX. differences so, as activity, rate patient to whatever the a decline. trial, with to of typically feasible, And of weeks a they to far really XX adequately CKD of transplant kidney improvement placebo is to of depends at or than trial in in the the design to off showing a dialysis important couple program we our in be able difference. most expect what’s disease forms patients kidney certain a are The or rare require with is show And improvement -- to those thresholds, trials powered not show function show us modifying treatment. it threshold trials most going are or separation from two showing important obviously FDA minimum less thousand a GFR one for PHOENIX showing

has so, eGFR worked these approval. why for to adopt that's FDA based And endpoints

Operator

Thank you.

Skorney Baird. comes with Our next Brian from question

Your line now is open.

Unidentified Analyst

the are This timeline wondering the the another current ex is rights from question. in thoughts I’m for on you to whether and [ph] thanks AbbVie’s back for Brian AbbVie's lay company? and rights opt getting U.S. what out are Trevor them, if for transferable just

Warren Huff

where retained States. summarize the are, commercialization So, economic all rights and just obviously in commercial we’ve to United rights the the of

product has of Alport Our Kirin and Kyowa Japan partner trial. syndrome they territories. the U.S. Hakko And as product to Phase to the opportunity in have rights Southeast in from of outside availability data option commercialize X an an to the late the commercialization as And has Asia. the the the elect AbbVie Kirin then commercialize

in to have So, that time. elect they at will opportunity an

things We the three launch and expect that rest that territories product will mentioned. or I the will happen, in world one of will they elect in we

We rights those either a in with will to partner for make arrangements the substitute or ourselves AbbVie. for launch territories place

Operator

Instructions] next from queue question Thalmann. Ladenburg comes [Operator Our Kaplan Matt in

Matt Kaplan

type just look of seen. bit CKD wanted of EGFR we out those soon in for to of X data from terms diabetes zero in we’ve in little change on Can the the IgA sense should you results expect the I given in CKD? that a etiologies and coming what two study of to in a nephropathy just consistency or help get us PHOENIX terms

Colin Meyer

improvements and that real So, I to function we’re clinically think looking kidney meaningful. in see look

falling. drug is rates increased. inflammation value never the affecting decline it, always we will kidney propositions that but increase different that been patients or But need is may all has obviously demonstrates mentioned, the can and us to of their if we kidney we function, more few-point that GFR, function. to dialysis increase transplant our improving stabilize a in different kidney function I threshold patients is these And historical kidney if underlying believe of magnitudes going I than isn’t for then be if indications as think across be may it’s So, see we meaningful see

increase and increase meaningful. about less would any more is be the it’s so, that there about And absolute clinically

real just And for. so we’re that looking an what and appears And wouldn’t we that’s same want expect to meaningful. increase we number and the exact see

Operator

Q&A further this back any at conclude am call in to now would turn our questions the I time. Jindal showing remarks. I session. over This Vinny the any Thank like for to does not closing queue you.

Vinny Jindal

updating and everyone look today. you to thanks soon. care. to We again Take David Thanks, forward for in dialing

Operator

and after Reata’s you Investor audio conclude be in on on this conference call reatapharma.com an will and the available News participating today's conference gentlemen, program. website This Ladies section. today's -- recording this in conference. thank for does There shortly after

You may great have all disconnect. Everyone, a day.

Reata Pharmaceuticals (RETA) 11 Aug 182018 Q2 Earnings call transcript