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TVTX Travere Therapeutics

Participants
Chris Cline Vice President, Investor Relations and Corporate Communications
Eric Dube Chief Executive Officer
Noah Rosenberg Chief Medical Officer
Peter Heerma Chief Commercial Officer
Laura Clague Chief Financial Officer
Bill Rote Senior Vice President, Research and Development
Scott Puckhaber Bank of America
Michelle Gilson Canaccord Genuity
Laura Chico Wedbush Securities
Maury Raycroft Jefferies
Tim Lugo William Blair
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Retrophin Third Quarter Financial Results and Corporate Update Call. All lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the conference over to your speaker today, Mr. Chris Cline. sir. ahead, go Please

Chris Cline

your our Good Dr. results welcome Thank and us. our all for Federica. will Today's quarter led Dube. Laura Heerma, by Officer, Dr. Medical Dr. will be you joined our Commercial Retrophin's Senior XXXX of Eric Chief Chief joining by Vice be and you hope Officer, financial for corporate Executive I for will remain afternoon, you, Research well. our the to Q&A Chief Officer; call Rote, Bill Officer, and and Rosenberg; and Chief session. third all families Clague. Eric join Thank prepared Peter update call. Financial the remarks President Noah us Development

like during statements would Securities the are everyone we Litigation within forward-looking that matters of Act begin, this regarding historical safe of to made facts not are Private Reform the statements I that remind provisions call harbor Before XXXX.

guarantees section involve from those actual implied as statements achievements materially results, differ of cause statement. Forward-looking to by performance. as performance company's press may today, unknown on see the not known the risks, expressed the filed the issued XX-Q earlier Risk SEC. forward-looking disclaimer release and Form Please and statement that They in are Factors and assumptions uncertainties XX-K the and or our well with

Eric. let statements are to X, me that, to call statements forward-looking obligation any events future statements or November represent our date views to made, the addition, turn reflect circumstances. such of And In disclaims such over as Retrophin only XXXX. now Eric? update any specifically With information, the

Eric Dube

position execution with our exceed meet our key the good a afternoon. outset would and rare further came throughout we that our this currently strengthen as for while we believe on to and objectives very objectives pleased report mission third the a you, key to leader our the quarter, of focus I'm innovation and result or disease organization in clear in of Thank delivering community the and our patients. a year, strong that At as Chris, are the pace XXXX. hope to on year, together

development ensuring priority approved, the highest living has with our been paradigm position and continued if that for will treatment to sparsentan, best efforts FSGS shape IgA nephropathy. Our people

maintaining pivotal Our are studies PROTECT advance, we high-quality DUPLEX to and and continue conduct.

am analysis and DUPLEX report on we sample analysis the to sound in positioned according that I the year, and note, this the also Based is first the sparsentan we in study well trends, completed, quarter patients we study FSGS Of to for nephropathy anticipate strength will data enrollment the are upon shortly. the and in progress. next line pivotal study Noah top to making this report pleased to be PROTECT IgA has recent year. DUPLEX size detail been of enrollment The continuing provide able DUPLEX. be plan to will from completing in of preplanned in in proteinuria progressing is approximately plan. eGFR confirmatory with additional reassessment Specifically, the XXX well enroll original

data of we quarter, of to During quarter next This our XXXth third as during puts us original now milestone, the patient achieved well the enrollment schedule. top an on is the in important the report study. it line year, analysis the ahead of track proteinuria from

its all successful preparation growth for year-over-year capabilities organic track teams in delivering commercialization if a our our us objective upon for products. XXXX lay sparsentan, the the growth of early of building groundwork products and approved. is commercial quarter, to across in organic key of launch In our approved Another drive extended record third

upon of is provides our a our deep maintaining in that our to needs earning guidance our to The development. their treatment product and understanding of sales foundation As patients in position sparsentan, outlined year be the built disciplined ultimately we of was through of and and for and keeping our families in successful growth approved. to mid-single-digit delivering a and the a performance journey. exceeding are This if for on they potential confidence philosophy this the outset final trust where communities, result, we XXXX. their the objective growth of net our at respect diversifying anticipate This patient business testament

criteria. meets OT-XX key recent all of Our agreement acquire to our

out significant strong supporting is As HCU, commercialization capabilities. science program. is rationale fit OT-XX ago, our a the the there announcement there we clear OT-XX call development clear two late-stage with development and classical need on or And laid unmet homocystinuria, weeks in a and

transition close to to and We our closing targeting of the potential forward expanding to the potential we first-in-class expect of look Retrophin. fourth XXXX. programs, disease pipeline bringing growth quarter during So conditions, exciting rare OT-XX

me Let Noah? now over Noah turn update. for call to his the clinical

Noah Rosenberg

in period study ongoing DUPLEX and PROTECT the despite programs, in sparsentan progress exciting environment the challenging nephropathy for to you, by both Thank presented pandemic. an study We're pivotal Eric. FSGS continued IgA the COVID-XX the entering the

used and operations patient pandemic. include FDA investigators with alignment and navigate supply, drug focus and contact the the sites, reinforcing In partners. Our are to documentation ensuring These study maintaining clinical CRO with integrity, safety, principal data on doing are EMA in guidance. so, a continuous and teams and ongoing collaborating key priorities preserving we actively we've

advance global in X remarkable regard to that into well plan. both that Phase sparsentan. it DUPLEX see investigators staff continues We progress also as continue dedication our as in translated to according patients and to continued the of families programs. am up pivotal This their to site to has network for report supporting the make and clinical studies study a pleased FSGS, I With our

also trial independent of was prespecified the committee, the Eric eGFR been the scheduled based blinded DMC meeting fourth studies the review. study. report as the sample in by mine the completed. safety concurrently recommendation proceed the The to their Based upon independent review the increase we in the remain monitoring safety completed As for upon to was both process assess am I has results, PROTECT. mentioned, DUPLEX no size planned recommended confirmatory portion overseen and data sample size. of data and both reassessment that committee to The pleased the

adopting easily adopted our FDA note, potential support the line confirmatory FSGS well as to use pursuit the increase can week both in XXX the in be a as a a eGFR top requested partial analyzing reassessment analysis measurements analysis. for FPRE, aligned continued or study completed Of measurement we to dialogue the of measurement surrogate our with proteinuria we as The ensuring the package approval of of a resulted of endpoint the objective FDA are baseline as of XXX generating and with also XX-week the from size eGFR XX-week confirmatory are the original This ongoing these in week and of in instead endpoint, power data with if from with remain on can eGFR we interim included strong to no filing the that remains. agency are week We aligned has approval Notably, DUPLEX size successful. accelerated management of a on that emission sample our in XX% an analysis. X results that accelerated sample its approval. path from

support of XXX approximately result, confirmatory with total the patients continuing, planned, to analysis enrollment as study. As we are the FSGS a with originally in

We rate anticipating months, year-end. in activity and have of in before we seen now of an encouraging DUPLEX are enrollment recent completion

planned current the endpoint upon any the the year. the of confidence our will quarter evolving We proteinuria first positive momentum the with in pandemic. size, COVID-XX related in continue changes proceed from Based deliver sample to top results as well we as ability to as to current monitor to line in enrollment, for the have clearance next

As milestone, our approach NDA we CMA continue preparation teams will their and submissions. this parallel for

XX-week teams, FSGS in sparsentan XXXX. a both is pivotal approval PROTECT in schedule. and from staff investigators and during IgA in is U.S. XXXth XX-week ahead efforts is accompanied analysis community, ultimately it data our from to as would to first new enthusiasm If quarter of of successful, the XXX and is achieved accelerated partners, nephrology data our dedication now as the from potential analysis to for and quarter. expected people site continue IgAN top strong of recognize living the the for and well line are us filings readouts like the with a XXX next nephropathy. now package to Listening third the the IgA report proteinuria The that it to from first patient ongoing of in to line top their Moving has as and have approved, believe the we strong care enabled enrollment in our the pivotal families notable, from our the become sparsentan position of are patients This positions for I successful year, studies if Europe. patients original support proteinuria the nephropathy. well the patients of by there to programs, studies standard that us be to study

we efforts around completed also in quarter, sparsentan the During initial Alport exploratory syndrome.

will we rather continue program solid approval for for We forward plans maintain approaches. our We will the have Following additional that initiating enrolled. number to original DUPLEX XX-week community us and time, Alport patients we which on move the to explore Overall, a that track a readout need accelerated in efforts the a not path completion without interaction sparsentan clarity study such the IgAN. PROTECT, The we in alternative quarter, in the but of in faces third thorough current We confirmed now an potential and maintained regulatory our analysis completed, size key that the operational next third be and considerations, that of to FSGS reached our the now analysis at execution clinical, of adjustment for according milestone was late-stage we feasibility and are momentum our and Alport had to of regulatory DUPLEX filing. and puts advanced proteinuria XXXth from the of unmet reassessment the of nearing quarter this plan development year. recognize enrollment, patient programs. clinical a and enrolling sample we on in potential focus

Peter Peter? turn Let commercial to call update. a over me for the now

Peter Heerma

Noah. you, Thank

important our organization ability treatment deliver maintaining their clear Our focus dedication of is options. commercial understanding to to a and the needs patients and

For as period therapy new of a initiating a approved XXXX, moderate the products, same across reported driven compliance. was we last XX% growth in over our all growth patient organic as year. of third This well quarter patients by the increase

Specifically, EC. for seeing demand THIOLA we steady are

to previously, the freedom for mark. that also potential EC of This suggested we all that can that and segments the cystinuria we research market our ultimately support of outlined would providing and provides THIOLA formulation discontinued administration patients, our patients of serves a had to to the two-thirds patients it approximately As prior choose a launch effective because needs in this the in ability high including of manage the degree demand And leverage exceeded our to listening launch tablets in treatment to to as Earlier potential to EC new continued a necessary approved. nephrology formulation. quarter, previously year, to reduce the the THIOLA confidence this of see our good It number for be effectively the from gives of option. the third sparsentan, testament foundation cystinuria. we we those original of if us robust the

gold pandemic. support in the evident cellular compliance. the of the as navigating we acid can and COVID-XX cumulative ability also third commercial teams ultimately to access therapies, educate quarter. disorder, uninterrupted provide spectrum HCU geneticists driven geneticists a This of educate is a steady the and pediatric is continue genetic commitment for seen team on our the to for in amongst we confidence efforts bile we as well bond and show had importance portfolio the by to as patients is hepatic drive challenges patients, our our whose patient in have serve in successful large strong in also This our the patients. of OT-XX well cholestatic and approved. performance of delivering part families Our the team's provides involvement that treating screening awareness patient resilience Overall, the to the This in increase be of as supply to

governance, will patient see for we physicians. shifts their potential insurance patient ahead, to as from to well Looking in continue any impact ability as monitor

We change in meaningful to date. either have a not seen

people execution has the likely we to commitment our trajectories, Importantly, the have need. guidance believe last the track Laura based will strengthened our rare confidence on and ability patients therapies all and through original demand And balance that update. organization for remains our access excellent mid-single-digit put to now will further deliver financial call with the commercial over has exceed medications of our remain important full our to the the for Through stable turn organization's in to over performance, year I that us growth of products current year, Laura? diseases. year. they living will on for

Laura Clague

Peter. you, Thank

basis, the quarter XXXX. development fourth non-GAAP third is the quarter compensation the depreciation period XXXX GAAP and an of million Relevant a for GAAP quarter, quarter of third net for our third a for the On the same reported period $XX third XXXX We third a expenses sales the net to $X.X attributable million. in quarter million expenses loss expenses basis, $XX.X for fees. administrative On basis, for quarter quarter the $XX.X of selling, attributable same XXXX. adjusted to million in loss GAAP fosmetpantotenate XXXX. higher the amortization. based and and R&D increase over net same the of were in decrease included XX% portfolio were professional general the over million. the in adjustments third compensation noncash third the On After basis, $X.X the of XXXX. we During stock- $XX.X the largely a $XX.X for grew expenses from noncash The million. Significant for to $XX.X $X.X adjusted reported and commercial period for product million, million amortization. a were an program of On of quarter expenses of consisted is expenses were increase R&D discontinuation noncash million adjusting income and tax, to in stock-based quarter. The SG&A compared

expenses as our For balance XXXX, advance the increase we modestly continue of that studies our to sparsentan. pivotal of we will anticipate two operating

out ended Importantly, upfront million fourth our allow closing comments. the now his to that $XXX.X announced quarter. quarter. activities. first the $XX planning accrued $X beyond in our from the with of this benefit support tax acquire Act We cash in quarter the I due balance of and Eric? would will cash receipt financial legislation approximately foundation the fund us equivalents, to million This includes agreement remains cash strong. million enables which CARES recently the including OT-XX, million and over to the pre-commercialization $XX readouts, operations be us and in It will call the hand upon expected closing invest PROTECT payment for DUPLEX also to back in Eric

Eric Dube

the I'm Thank through this you, incredibly of first members months year. work and Laura. of organization's pleased a their one to resilience approach nine with our Each clear continues team with XXXX efforts momentum. our progress patients the our dedication for the improving meet rare community. with of key objectives has the lives us positioned Collectively, in to or exceed our disease and to strong finishing year

build our program upon commercial capabilities, promising deliver to further year, expand integrate quarter channel OT-XX first next high-quality in strength to this readouts the the our momentum sparsentan and will our pipeline. the We studies of beginning from of

the for turn Q&A. call to open to Chris? up now back me Chris Let over it

Chris Cline

Q&A, Federica, lines up Eric. Thanks, open ahead we Great. the please? can go and for

Operator

[Operator comes with Sure. And your the Scott Instructions] from of of America. Bank first line Puckhaber question

Scott Puckhaber

Hey, guys. my and Thanks the for news. on taking size sample congers question

a know program I So out? have much can we looking on we reads be maybe yet. And your you from on DUPLEX's line us I data view get we PROTECT? for potential read-throughs top what too as follow-up. when had give closer should then to readout, that that haven't And

Eric Dube

for the Thanks Sure, question. Scott.

positive sparsentan is with diseases, the DUPLEX FSGS. addresses of support, efficacy for and with of reinforce certainly very readout the in to common for assuming the understanding glomerular quarter these important going DUPLEX hypothesis that mechanism one, be the results, profile So action as and proteinuria pathway will profile well or in the as the And specifically the safety disease. in that tolerability potential to regard our in that

that are the as certainly, studies, progressions. say, caution I'd different about want do of think in PROTECT, different of that is to populations different plays type proteinuria. studies two role the that disease some sparsentan they with patient to are the But read-through and the I Now we there read-through reduction

want proteinuria that there of until cautious to And safety third be may data in be year the need we we're while see to and to going nephropathy. so wait quarter some next to read-through, the IgA

Scott Puckhaber

Got I that it. And regarding interaction say you with That's helpful. think heard I had you an regulators sparsentan.

if vice them? just proteinuria, but on have DUPLEX in Or have through thought had maybe not the versa? significance what So any or data you study and discussions ultimately happens with in are in eGFR, wondering, mixed the you you've

Eric Dube

to I'll continue clarity question. any ensuring interpretation mute. results would have insights size or expectation Bill results may assessment. I the think and and on the on share further with we certainly, focused Rote And of any we on endpoints, you for to conversations kind I We're what mentioned, Well, of our sample regulators, caution of as the your be might ask on Bill, be.

Bill Rote

question, interim it's data full Scott. component not Yes, the that But mature. an will of We'll have set data be eGFR the interesting at Yes. proteinuria the analysis.

eGFR endpoint. agency the plus that all the for at okay, accelerated That's agency at the So With way relative in look study look the expect the will right the on reductions point surrogate and but going results the say, agency approval, positive trending did the complementary it's endpoint data not the what does the at to any data, be in to proteinuria, direction. predict are drug in surrogate we incumbent is to at just upon the this at looking that evaluation the comparator that.

Scott Puckhaber

Got guys. it. Thanks,

Eric Dube

Scott. you, Thank

Operator

Genuity. Canaccord And your Michelle next line question of the comes with Gilson from

Michelle Gilson

the for congrats my guys quarter. on question, taking you Thank and

submissions what I the readout, you guess regulatory on following your of – the is potential anticipate anticipate then terms Do the a statistically benefit? process? in eGFR for there looking timing significant the clinically Scott's entire you a and question. timing that that I as up I guess, statistical, meaningful of regulatory Just eGFR is benefit guess, And well in around as you're

Eric Dube

for couple readout. the eGFR take to with you, your of first Thank the questions. regard I'll timeline the Michelle,

bit that timelines think I'll patient where thereafter. to just years about going patients be a meaningful to over regulatory eGFR enrollment final the beyond about that the a it Noah we're two outcomes enrolled, And I treatment renal minute little bit I the patient I to a informed regard really once submissions that would talk the as have of complete we we for before after to Bill have mentioned, milestone. change best which, XXXth when understand near the is approximately anything for XXX data. confer milliliter what starting ask in annually in patients, be changes glomerular mean or is announce Bill, we would the it expected one we would then to But on hand long-term effect. little with eGFR, with benefit clinically per diseases. enrollment

at. would difference And different assume as that the for to well. powered would be have so statistically clinically that certainly meaningful certainly we be We certainly we that looking be a threshold would

So bit the you do can after assume that little Bill, ensure two the to would those further to that give detail they're – timelines? on a separations we you sized want and show regulatory study powered we years.

Bill Rote

Michelle, think filing. I I don't our – you're for first the to ask Certainly. about timing And

to and analysis looking forward forward in looking – QX of announce this of from QX to that. XXXX, world interim to expect have year, to We the to data the sorry,

the work year. we're be half the in of the to filing needs anticipating that done that, second to a With analyze

the it's Subsequent as but follow Subpart EMA the Won't get close to – will filing the simultaneous, as FDA. thereafter. that be be going with will under filing closely we So can it. with H for be

Michelle Gilson

with – think point if few I currently the and evaluate guess to sparsentan if how managed in quite one landscape. IgA well. And as And curious there combination studies approved, you just at of control. any blood I'm are follow-up nephropathy it. just kind agents some with have you within are in those others Obviously, Got are ongoing. of IgA nephropathy these primarily a plans pressure sparsentan patients any of

that about market of kind just so maybe of I And it could Or you are guess you're thinking evolves? of targeting mostly diagnosed how newly you the switching as how process? imagine kind us an patients? give you overview

Eric Dube

Sure.

a evidence So ask the with little evolving. market Peter IgA our about how and bit certainly on generation further to nephropathy I'll and Noah then to Noah? see thinking regard add we share can combination, anything

Noah Rosenberg

Michelle. Yes. question, Sure. Great

component. terms of agents out are majority the In there studied in being IgAN, that immunosuppressive currently some have

And so at. right, also is have the well as – then that looked been there SGLTXs, and

And seen. mechanism and wouldn't to able really be so we regardless that to reason we've of the sparsentan the is there the additive based particular add that no mechanism, of into action data or those, believe on be

So the there has we think developed that whatever for being is out currently potential complementarity.

key first point. the that's think I So

as mentioned, clearly, a we've being once-a-day oral. terms think in advantage non-immunosuppressive got therapy, I I of an

some So sparsentan. there are advantages to

it's think thrust results to But the we've partly I positive speak I COVID to if that's think I there. that. of in recruitment my in really thought the want how don't you Peter, such main know, market? had because of

Peter Heerma

Yes. Noah. Thanks thanks, question. for that And Yes. Michelle. Certainly,

new cascade. more mechanism the of believe I we is also profile action, standard of the information product the therapy think it's have step Listening the your And as of standard are downstream molecules one sparsentan very FSGS, but those leaders, be mention Other high, they think take complement, I promising, sparsentan the at position programs good in need. but I that look could the and more as this that our are immunosuppressive And but is often to we need a opportunity we be care. unmet care. to which in sparsentan, to potential also and think IgA development of in new and in thought could a question. see that unmet pleased complementary to nephropathy, they both the back really component to or

Michelle Gilson

next for Okay. quarter. Thank congrats questions, taking and much guys on so my you

Peter Heerma

Thank you, Michelle.

Eric Dube

Michelle. Thanks,

Operator

Wedbush with And Laura your next question of comes Securities. line Chico from the

Laura Chico

tolerability. for I’ve one Good question. got sparsentan afternoon. Thanks on taking the

DMC review. So congrats the on having fourth

surrounding adverse could a expectations little around the delve profile. more you event if into – wondering Just

subjects, we're question gotten in around of is as the to specifically DUPLEX one the edema, ahead So looking readout. impact we've

should us what about versus understand clinically And maybe quick we I one be meaningful. considered have then So thinking manageable follow-up. help how would be

Eric Dube

Great. Thank you that Laura. Noah, like take one? would you, to

Noah Rosenberg

Certainly.

step that So let a on back me question. take just

keys got patients disease with in FSGS, state, especially the in venomous that you've at hands of FSGS well IgAN, highly One treating the of this whether or that edema. in it's understanding are very versed patients is nephrologists

I can think in look you So of the see instance you when of levels for DUET, some at that. baseline edema,

think important got it's And a to of to years. the We've thing extension The so edema, I months. it's patients recognize we've that of open-label a now nice within the followed percentage we drug-related XX.X for the is dataset small that overall. have out realm six got median a in

So moderate is we've dose-related mild and se. a really study. not pretty per all We're seeing dataset, seeing again, we edema going We're we're effects to duplexes don't strong of on long-term the – a explore a see category. larger we're that got But dataset, there. to

again, So that really long-term seem tolerability. be state. it concern. monitoring we're a got we're isn't within so to certainly this again, But significantly this following. something doesn't It's set large, and data impacting we've disease And major

Laura Chico

one Okay. helpful. Thank maybe last one. you. That’s And

either positive, negative? administering I'm mechanism you. fixed-dose mentioned an having agent doing the about do Yes. dual of thus Thank far, the agents I think any reactions having to compared how titrate? to of you curious, and a ability research. Just benefits market you single guess kind

Eric Dube

that, with any Peter Sure. perspective and has their insights bit share I'll I'll nephrologists about to my that on ask little and research. market in share speaking a he

with standards combinations the are I I which think like those titrate diabetes, fixed-dose whether, COPD, So There for and fixed as Laura, in like about part and essential HIV, combinations of of worked and down of these are questions asthma patients, more therapeutic again, have of not to a specialists who that care up of number all areas academic, whether combination. a where oftentimes different combinations standards have, care. are physicians areas it's fixed-dose

there is see use about that – want this, a We would ARB. that you it's ACE ask know not know bit of in managed. with a course convenience some that you different But fact, an combination, finished products, perhaps you and thinking not oftentimes, whether on of remind out effective seen to the I'll molecule insights in fixed-dose safe questions really share regardless, more sparsentan to the and play I'll physicians part disease is commercial that some how have dual or Now we one mechanisms. I've and disease. little ACEs is a or but once in that therapy, an role this ARBs a play success of Peter, specifically critical and that are

Peter Heerma

– And Yes, mean listening that thank to very the market quite that good. for seem the research, mode as you, of physicians comfortable as to with Laura, well question. I speaking the be dual to physicians that action provides. sparsentan

we currently amount not for also patients been, As the standard large of a know are a managed. But care. being that RAS has of time, inhibition Eric mentioned, long those

market I comes patients we being XX% think out this managed. of In FSGS the sparsentan game. fact, of research, And not are that optimally where over see is into

like the additional level power receptor that physician to a that mechanism think really antagonism, that see. of would provides to down page to think I I additional endothelin

like So it's part, are available. physicians quite with that's receptor to expect makes dual building endothelin a And mode on that feel I adding not that logistic component, the as we but currently endothelin see of action. comfortable said, well. RAS the effect there That antagonists

that sense. I this a So think is makes that – is combination

majestic. I think they're

fixed it's tool We a that haven’t any heard mechanism. concern

as it a contrary, in think, view actually physicians possible. I

Laura Chico

guys. Congrats the helpful. progress, really That’s Great. on

Eric Dube

Thank you, Laura.

Operator

from Raycroft line And your comes next question with Maury of the Jefferies.

Maury Raycroft

I'll question Hi, on everyone. the well. Congrats commercial on the I progress ask guess and to not a side. as resize having

seeing you're specifics the starts growth commercial If you comment other how maybe into compliance, And new any can just contributing? are provide variables more THIOLA with EC? or on

Eric Dube

turn one Maury. you. to Thanks, I'll Peter, over that

Peter Heerma

that. for Thanks

particular. EC and We THIOLA with have in the THIOLA, of been very uptake pleased

allows As more the better you intake. can without the importantly, think could the burden for and patients. makes I EC expect a And reduced compliance flexibility really more formulation for difference because pill food They it's with that for it patients. take

have could you expected an element, fact, and of in what that that's, from see. compliance, think I So we improvement

good environment a Additionally, I now have current of these in in never within patients stone. hospitals. think away kidney from COVID, it's to stay But want the the circumstances, to particular,

I have now patients THIOLA, component is home. a then maybe every there due months. little three feed And XX-hour a the urine think there's bit home are also With at test additional right it's to that advised to working into could from more ironic being a compliance.

I more home. think at there's patients

increase needed. think for that allows you adjustment dose if early see also I an there, and

Maury Raycroft

it. post Got the on at any you who X.X complete on some who achieve sparsentan versus background Then That's complete where received a hoc also patients there for response. the UPC a reported helpful. had a on very visit had data you as patients showed And response analysis then not X.X ASN, immunosuppressives question well. had that of you I did that

you ongoing factor just enrolled? data to the based respect wondering And I'm so hoc if the Phase study X in contextualize that into can post the patients you've DUPLEX expectations of type and the how data on your

Eric Dube

take like Sure, would Maury. that one? you to Noah,

Noah Rosenberg

question. Great Sure, Maury.

able to on And patients We ASN previously, request data. nephrology as So which a I achieve at community. just just remission. the X.X also imbalance when that's or analysis nephro the you were And baseline the the think at was are substantial in able a of the published percentage hoc were sparsentan – want We And remind extension of is at think less complete complete looking than potential the to protective ability. percentage open-label patients achieve steroids. mentioned sparsentan academic the FPRE extremely DUET there I the message and you to the on post baseline point patients was everyone, I of is who steroid remission, of use, aware, supportive is essentially and there, first this proportion UPCR. key the that highlight of to

patients, results So did the the the still to two would steroid were steroids recall, an of they We analysis. if show question sparsentan’s looked there, add regardless That steroid And or at wasn't were low their steroids. read-through we was they terms of quick use, that – dose steroids is affect was, my effect. the in point of week there question. on to kind many your these there's be on I'll actually whether did able and on or on stable that – one XX years because were of had dose, do you more – impact of not, results. data, we ago

not And may been few, but have so result overall a on impact there there. significant likely a our

I think asked you – say about Maury, summary, to would I DUPLEX. So read-through in

that bodes I that, well. saw But of the – I'm to was You them. a dose-related just of but analysis, plausible far, effect on, we control. or not asked that think to well. beneficial nail on compare. DUPLEX, XXX, no And Again, the think that eGFR goal I would cautious the XXX-milligram from reduction. that, dose. to make be the proteinuria And hoc want questions, going it's don't it, post lot really as the the that's to out expect directly same impact DUET I XXX out. it's data the multiple thought I make get of thus it's Hopefully, a directionally your to Maury. just well great directly questions hay of all There's our and answered DUPLEX, sorry read-through expectation just too we set to The think Remember, I DUPLEX I there, thesis. supportive supportive XXX. sure is It of of but was say much a

Maury Raycroft

questions. taking very Thanks Great, helpful. that’s for my

Operator

And Lugo your comes line of last Tim from question with William the Blair.

Tim Lugo

just you you ACE me how saw that about data improvement clinic? that especially, can squeezing mechanism in the will into Thanks you think you in. how dual-acting as was on maybe translate over preclinically, expect, these show the auditory clinically, Can what could benefits guess, I inhibition? interested the an for preclinical And by I syndrome. discuss Alport the

Eric Dube

the for Sure, Tim. Thanks question.

So ask the not thinking Noah, I'll in Phase the some to making ultimately regard you that to to team with your of cover the had some of pursue but also X. a decision preclinical, thinking

Noah Rosenberg

Yes.

the function structure preclinical as impressive, both hearing well we model as to Alport and of the did impact. data a renal quite While the point, kid see benefit was on and to regard with Tim, a your

deal get that's and really we pathway, team big picture was where to think – a the regulatory into and slower Alport to the study, great proteinuria, clinical a fits read-through time is came but a this Alport preclinical much again, IgAN. up Exciting data. of in the our our – for, think figure the spent is think, I progression clinical from the late I path there with to of study, a I challenge proteinuria analysis to that out trying way a and or in FSGS of common than

link that with result, to and link have, simply Alport. the IgAN is FSGS in not proteinuria strong we between outcomes there the As a

other to year. not There's that important an why our our look really and continue we'll forward that's across late-stage maintain QX on community for readout incredibly diseases. pursue and these to focus so engagement for community. pathway study. And going We'll FSGS for a common QX IgAN, paths, but readout our next decided a we Again, respectively, maintain with

Tim Lugo

calls Understood, after miss close had here. for definitely the you I thank I that, that. seven

the So thank for me opportunity. back saving that. you for on Thanks

Eric Dube

busy We Thanks for day. know a it’s the question.

Tim Lugo

all. problem Thanks No everyone. at

Operator

concludes session. remarks? any this further our you have closing Q&A And Do

Chris Cline

thank and Federica, you, joining this for you Thank us afternoon. all

a As call our look night. additional all today, sharing this as and of balance and exciting with Thank have forward the concludes into progress XXXX. year you we Federica great this you for through to we and move an mentioned,

Operator

Ladies concludes and this today's conference call. gentlemen,

You may now disconnect.