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TVTX Travere Therapeutics

Participants
Chris Cline SVP, IR & Corporate Communications
Eric Dube CEO
Noah Rosenberg CMO
Peter Heerma CCO
Laura Clague CFO
Bill Rote SVP, Research & Development
Maury Raycroft Jefferies
Greg Harrison Bank of America
Joseph Schwartz SVB Leerink
Michelle Gilson Canaccord Genuity
Liisa Bayko Evercore ISI
Laura Chico Wedbush Securities
Call transcript
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Operator

Good day and thank you for standing by and welcome to the Travere Therapeutics' Third Quarter 2021 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. Please be advised that this call is being recorded. [Operator Instructions] I would now like to hand the conference over to Mr. Chris Cline, Senior Vice President, Investor Relations and Corporate Communication. ahead. go Please

Chris Cline

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

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

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

statements information, Travere I’ll to Eric. future disclaims reflect over specifically any In circumstances. as of update views XXXX and statements turn made, or forward-looking our to now addition, the any call are With only obligation represent XX, Eric? date such the October statements events such that, to

Eric Dube

everyone. of quarter. progress during I the of the by way third proud made and our Birthday the facets Happy Good Chris you, afternoon business today. Thank across all am

with study. interactions for the we engagement pre-NDA our the very progression the expect of prevent effect the approval submission pleased study alignment U.S. sparsentan the approval first in FDA we've Notably, planned stage and submit in quarter attributes of the on agreed treatment upon feedback on well-controlled an And accelerated application seeking are community large agency's Based in kidney support to our next nephropathy. disease. that FDA PROTECT to by our standard end nephropathy its with significant to X to accelerated for that year. that subpart August, H. structure with IgA in pivotal expectations the positioning IgA First, a the compared its for reduction of control magnitude we In PROTECT we safety generally goal to first primary report treatment significance time proteinuria reported nephropathy achieved interim interim become in ultimately analysis. patients of a demonstrated achieved receiving to endpoint of I the with FSGS and irbesartan. from profile And than statistical has and to-date. study time three-fold well-tolerated demonstrating approved. sparsentan in was greater consistent milestones active new sparsentan this assessments, our observed am if that know the what from that proteinuria This is IgA results a completed is The help related baseline several nephrology sparsentan at to our the our reduction non-immunosuppressive the to proteinuria today pleased exceeded for a single in those these precisely physicians agent Phase prespecified report the I'm with interim under we analysis our NDA, of application of from the the

an expect XXXX, FSGS. eGFR with the NDA which they FSGS of on for the from long-term study, prediction gained If anticipate program approval approval our the progress benefit the on the data further continue pathway for plan to we FSGs year. to submitting first the next we ongoing additional in in FDA the of the enables study accelerated during Most half provide middle for sparsentan meaningful agency made importantly, with DUPLEX data eGFR on accelerated strengthen our also as in the We alignment additional the quarter. should for us we of

the pleased to nephropathy path regions. and most nephropathy sparse FSGS sparse approval believe submissions it available achieving pleased success both IgA force have potential next formalized accelerated probability strategic regulatory for entered a the optimal our and combined nephropathy to We to U.S. in to This making are will to us and allow that am Europe. a percentage a will we internet IgA for we market clear accelerate for have expedited year. and in share submission those increase for both I'm in that FSGs decision And achieving forward now of we IgA the path we to look also FSGS plan across Europe, pursue access pursue

also on they the relates potential DUPLEX option and totaling look the milestone these We of $XXX and sales with and payments in IgA request in making to our with portfolio Australia, of to and launches, the the continue The and up to next in up new for Vifor enter dedicated this the success be to a XX%. foundation Vifor incorporated, it with million Europe, XXXX. accelerated Europe, significantly sparsentan in agreement joint allows into the collaboration will a as for Europe, regions potential in rare sparsentan, can Europe nephrology Pharma engagements with Additionally, to closely increases New the supported. financial New allow shared EMA FSGS approved. integrate Zealand in needed and Zealand. value to have their expect probability focus as to and of us if mission bring and review it across strengthens substantial for pleased launches leaders the planned the working we standard us collaboration if were for recently And markets. all aligned prepare of data collaboration eGFR two nephropathy This application licensing recognizes with sparsentan additional into study very launches Once our forward for We to will assessment potentially Australia, strength successful it from Also, our sparsentan to be mid the these treatment process year. beginning royalties as can submitted MA commercialization

continue steps believe Beyond HCU. remain X,XXX a data and And be sparsentan, classical homocystinuria it encouraged therapy or we now adequately named has than we on not the U.S. encouraging the who disease year for as the are that for are We in program novel the if to by X/X before the current the program end. our potential We modifying Europe the to from treatment COMPOSE next the forward to responding pegtibatinase more we first ongoing to people preliminary the in potential for look expect. study assessment trial Phase track options. to for establishing become

I'd Lastly, organization commercial to the third of highlight in the quarter. performance like our

COVID-XX despite sparsentan Our approved environment the and the execution quarter led ongoing created across growth to approved. by products, the This underscores another challenging successfully in our all of pegtibatinase, confidence performance if pandemic. year-over-year deliver to ability

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

Noah Rosenberg

we statistically analysis from receiving from of potential that ongoing XX was ACE on been P have weeks a Thank during the Phase nephropathy. I notably treatment X living effect our challenges associated a and from you, potential in widely extension Most inhibitor a to a patients results PROTECT FSGS. the study. mean years need upon XX.X% of of the treatment, diseases. the X IgA safety powering interim and consistent study patients sparsentan interim sparsentan profile mean Eric. rare with time This advancing in proteinuria value the with and X.XXXX. and of long-term the sparsentan of more potential FSGS. at sparsentan profile. Phase approvals path less meaningful eGFR generally reduce proteinuria therapies new quarter, of of the positive DUET data above the irbesartan meaningful Preliminary a while our data to than consistent third baseline continue of patients safety pivotal after After These a and nephropathy confidence immune This compared IgA towards do helped indicative safety therapy the several clinically further study and Including supports to both label meet data has of interim clear reduction were open available demonstrated and significant appeared and for the where topline reduction progression from with of clinically with and end towards two with proteinuria built we clinically here And potentially the reductions it use sparsentan for nephropathy in avoiding suppression. IgA of In remain our XX.X% encouraged robust XXX of ARB than meaningful achieved nearly has the seven steps took quarter, result treatments first-in-class very of people for top meaningful assessment, pleased years with for so, potential the proteinuria and safety of to patients. treatment. shape baseline treated a to across to the the therapeutic sparsentan well-tolerated option meaningfully a be previously observed at be perspective, that over pipeline

application, and our study we of completed the application the interim alignment we quarter for on earlier, this the agreement Subpart be continuing supports submitting will under preparations nephropathy pleased FDA's from mission the first With for successful the our pre-NDA outcome. we approval the our of year. content The and with mentioned PROTECT IgA accelerated are Eric H next As expectation was analyses of very the in interactions recently that an and NDA of organization clear. feedback with

for IgA the for these as advance studies markering with FSGS the to are In working for progression maturity an prediction long-term parallel, authorization well-positioned in expectations, of year study data we'll U.S. eGFR combined conditional and Europe, of years of of to patients DUPLEX the endpoints and we continued the of the time well. be application treatment where to have have the gained data of our accelerated recent program cut, the a of its provide and alignment eGFR with additional XX% this planned will the agency half forward the with completed approximately the will plan have sparsentan momentum a application and expectation If anticipate in year near year XXXX. least submission submitting of the remaining based these MAA PROTECT with at benefit. two year treatment. in sufficient interaction, FSGS confirmatory FDA of potential completed date Both timepoint, the upon a in the the At approval. first type study meet sparsentan will data mid-next one and continue the FSGS also nephropathy patients Our data for accelerated support in on A DUPLEX we next believe on all mid-next We for to at [indiscernible] approval strengthen NDA

study in Lastly, When safety, weeks fashion study, a continues entering Phase being for to factors. be a an pegtibatinase effects pipeline, programs our we'll COMPOSE label HCU. the optimism end. on in XX as cohort dose from remains the are extension each preliminary X/X a designed tolerability, examining in through pegtibatinase assess COMPOSE study escalation and the a to high the for the before assessment are with Patients up advance is few it blinded preliminary open year pharmacodynamics, this we of patients anticipating pharmacokinetics, and clinical to evaluate study. data, followed the in before we

of safety, would this response. interest, signals nature as of study is for with you expect any any immune including we'll early be looking First,

of treatment who we targeting potential patients below the evidence get micromolars non-responsive, for level, clinically this of to for our We the When physicians new If areas focus. believe it total early of over commercial Peter? a typically treating is now provide homocysteine. the patients some turn XXX this know later insight Next look these option. have we'll we become year, could to to into BX below meaningful patients update. update of efficacy. those I'll call to are Peter pegtibatinase that provide

Peter Heerma

Thank you, afternoon. good and Noah

strong are patients environment resulted compared times. In period with across commonplace organizations this in where quarter, patient X% still ATP their especially that to growth organic we compliance our continue commercial performance, year. be last our product We interactions in very the to was remain execution visiting see over and virtual the driven products. physicians pre-pandemic This net and fewer sales demand all by pleased third same in underlying

ahead. Thiola of the patients our to-date, have impact the that the do For quarters new we the the entered prior experienced see initiate to we products, from still treatments. limited quarter. on we version formulation Despite Thiola impact in an impact market limited sales in so And anticipate generic far, continue adverse original the

on patients remain perform stone support portfolio also to will identifying our potentially therapy asset focus providing in free. The continue and important the new needs patients, many Our with and bile be ensuring expectations. to access that line service to

and last net As mid-single-digit sales low the a portfolio anticipate performance with over year we commercial result of the the product strong two growth ending over to quarters, in XXXX.

dynamics, the pandemic a launches would further and bolster in abilities evolving and going this sparsentan. XX of Given our be anticipated COVID meaningful period critical the a into team's confidence achievement for

with is to time for awareness with had launches the and exciting are we IgA XX,XXX opportunity of launched U.S. living and there sparsentan We greater nephropathy in we the for launch be us. in that likely both be have that planning And opportunity sparsentan of the patients XX,XXX believe between approved. IgA to now meaningfully diagnosis. incredibly nephropathy increase are an good we U.S. We IgA nephropathy over front in if In candidates and in anticipate alone, FSGS and would believe first

We are patients. our to well-positioned journey embark to on these reach

has organization know for We are scaling infrastructure critical position market strengths programs diseases. rises and rare growing our to living learned the and that provide the nephropathy to core most we with data patients in rare be sparsentan PROTECT of the points support profile will proven our of top with in we development. prior a from readouts, the desirable research extend our emerging studies to and services net by product nephrologists, that And an

our our I confidence to team's that topline the of confident from we our potential new life-changing standard sharing great we we a record from add we strength And will living position nephrology in to announcement, strong be sparsentan if have prepare since that for the sparsentan more positive data establish look approved, rare the the continue therapies are to the upcoming diseases. with community PROTECT Given be to in people received forward ultimately as to IgA the launches. our progress track have about of I interim ability feedback nephropathy. and treatment Overall, for to multi-year organization delivering as

turn the now the update. me Let to call for Laura? Laura financial over

Laura Clague

Thank you, Peter.

$X.X of $XX.X for in $XX.X part loss amortization. was third expenses is non-GAAP net administrative and sales net Vifor of compared for third the quarter million of We increase On an million $XX.X into This of million $XX.X selling, $XXX.X as of joint million the equivalents. product for well with quarter a The to $XX.X After for and non-cash increased adjustments We in and $XX of as reported Pharma On third the upfront R&D we XXXX. agreement XXXX, third as the the stock-based of we and On the million a million. financial million collaboration reported quarter to million were advancement fees. expenses commercial tax, to cash the we amortization. in the licensing from GAAP a third expenses studies portfolio period On adjusted basis, expenses increase XXXX. position the quarter quarter loss sparsentan our were strong $XX.X with and XXXX. million growth For during basis, million the in attributable compensation GAAP payments general, professional for $XX.X balance to patient Significant The XXXX. ended compared for for headcount net for were of quarter. stock-based is of adjusting expenses the operations HCU. largely XXXX. of entered R&D for to attributable expenses depreciation for the non-cash an includes million the to compensation $XX.X the pegtibatinase SG&A third XXXX company's of the and third basis, consisted program million. basis, a quarter quarter involvement compared adjusted largely $X.X were of non-cash ongoing quarter and cash in quarter GAAP that third Relevant the attributable a received same XXXX quarter the the income in increase reported included

in expect operating increases we balance expenses. our of modest the this For year,

look and multiple of additional support not to I'll support impact balance call we into further launches, As development, investments cash generic this next back Eric? our anticipate potential including product operations his but the account business Thiola, over into Eric comments. XXXX. year studies as of significant the hand to our the we pegtibatinase advanced planned potential continued we closing for we for out, Taking program. sparsentan prepare anticipate ongoing throughout now

Eric Dube

X the Phase Thank you, our made impressive progress the organization's programs, study. delivered our Laura. results quarter. across We in pleased We more I pivotal sparsentan considerable PROTECT couldn't be regulatory with execution collaboration our to a from a and with sparsentan maximize the deliver Australia, into we to Zealand, nephrology to continue agreement need. in effectively in patients global products and of approved in Europe, entered leader New value third

the now FSGS steps submitted in And successful and three to our prepare year. on applications sparsentan earnest be and we high launches be nephropathy NDA to of to if With next will MAA organization regulatory pathways for to will set, working our approved. quality IgA we execute prepare continue

our new the NDA forward with look Thank to advance continue working to We I'd as Lastly, year Executive applications. announced weeks next the end MAA a position. this coming role a contributions clinical this of like ensure and us to months Noah smooth his prepare we take year. Noah. closely and to thank of him all studies at our to an Noah few opportunity and ago, this his for strong transition in transition role planned the to getting in to you, for Advisor we

Chris? Chris over Let now call Q&A. me turn the to for

Chris Cline

Eric. you, Thank Great.

open and Q&A up the ahead please? go we can Justin, of line

Operator

from come our And is question Instructions] going [Operator Jefferies. from you. Raycroft to first Maury Thank

now Your open. is line

Maury Raycroft

the My the about birthday, data more if it if and first on relative mature for analyses you we is FSGS FSGS talk eGFR similarly? adequate the meeting confidence that this update can IgA more have the say submission? And everyone. because Hi and question can we Congrats IgA can regulatory mature nephropathy that nephropathy pre-NDA to Chris. FDA that will of more enabled was that were update, data concur interim happy that to assume

Eric Dube

to much I'll the questions. so Bill. over that turn thanks one Maury for

Bill Rote

were that Yes, represent study. Predominantly, DUPLEX the Maury. study the eGFR six very comes question began That The behind PROTECT different. about from of thanks. enrollment the Recall does dataset. Thanks couple things. a picture study a mature dynamics more for months for the PROTECT the

building infrastructure a behind. study done the PROTECT work and the on So, study drafted was in DUPLEX the

a two other with To -- question of So, linear in in a very fraction And that efficacy greater your of much the later was studies when your for diseases look that the in PROTECT that -- and I saw we sparsentan contrast to had study. aspect enrollment FSGS, timepoints. dynamics, program, was studies. the has and in confidence stark those linear building other we has with across out been what we think the the consistently across performed much three dataset

So, line going give and in it's allow when DUPLEX, we'll and spring to the is have data that come mature expectation expectations. will picture that us cut in answer. to that in you the the our meet We'll our

Maury Raycroft

maybe mean, follow-up. I one Great.

for and review what IgA period for your nephropathy? If expectations just you their remind FSGS both for are programs

Bill Rote

So, we PROTECT for priority will the requesting be review. study,

this -- would end this believe PDUFA we mean and drug if dataset, review, if we'd a the the warranted an XXXX. before that then we first in quarter, from which priority the have we date answer of granted agency, disease So, are certainly submit with we this

the be interaction year in FDA eGFR filing. data's those are should of to a mid-year following For that FSGS, that filing, expect XXXX would the on and we next with year, cut, middle submit

standard be if in the half first So would And XXXX. of priority that put in half of early review, would it XXXX. the second it's

Maury Raycroft

Great.

taking Congrats questions. again, Okay. my and thanks for

Bill Rote

Thank Sure. you.

Eric Dube

Thank you Maury.

Operator

you. of And from our comes thank next Bank question Greg And from Harrison America.

Your open. now line is

Greg Harrison

taking guys. Thanks afternoon, questions. Good for our

steps it we the the would you of there? And then what is, expect to see for what extent to assuming the be pegtibatinase. the next could forward? data of that is And one this be would program clinically coming if data consider in First on the supportive is What it are moving readout? meaningful

Eric Dube

Yes.

the can thanks ask the for So And one much then first more Bill little Greg on I'll what so questions. the around bit to next steps. a I'll share expect. we take

So this from as at analysis key looking the were couple Noah composed with really mentioned, a you study. of areas

the and humans. in is first foremost, this study First

want safety. So a on have we eye to particular

in is second meaningful, different The aspect response and this trial, homocystinuria. whether micromolars below given think patients dose stay XXX be able third, and what get in are treatment studying is really those to assess and to particularly is then And by cohorts. That that for total they're considered clinicians I to and around would dose of the goal considered whether below the patients to homocystinuria, question guidelines are your levels. able with the clinically understand we the

threshold. we we'll we're to continue steps. obviously it going about as But over areas what so looking turn analysis. And major particularly to those And of that talk focus And next Bill be at assess the go are into I'll to that. that to

Bill Rote

Thanks, developing manufacturing able share with about engagements be once And and phase downstream then Eric. that interim analyze to degree. we'll The to development, the analysis Yes, their well to those the step toward going study, study. from expect as the first Natural interim and be that immediate work we've be from and pivotal regulators. development. analysis, from And to be to scale to more share input to be had We'll plan the analyses do results data from dataset that the we process least that a History the really up the as agents. next into feasibility and goals Compose own In COMPOSE clinical ultimately next engage for next on move some step data Study. use is the at study of that'll a and study. of will to parallel and the The our that working with the current take we'll the

Greg Harrison

Great. sneak then can I more. in And helpful. one That's if

there? you IgAN there the would AdCom be expect that would needed as an far in program, As

Eric Dube

No.

whether of their we The an on One you have our pre-NDA far, they've anticipate calling based on in questions as the with positive? this data from the surprised can have. interim prepared. for not that interactions called? we Committee. Advisory agency and That can seen AdCom things the a change will But We're thus they said that we'll these asked that don't data said, to not perspective or point, analysis, given was the see AdCom. Should we be at an don't expect an be

Greg Harrison

Great. progress. Very again all helpful. Thanks congrats again, and on the

Eric Dube

Thank you.

Bill Rote

Thank you, Greg.

Operator

And thank from comes you. Schwartz question from next And Leerink. Joseph SVB our

Your line open. is now

Joseph Schwartz

analysis? very much. the Hi. for the FDA FDA? when wondering has of was interim the your more as And company will any interim you you just the the on half your will we that the at data be whether to all will Thanks if in the first next occurred be perform information feedback plan XXXX? analysis DUPLEX of for you to I perform of likewise, hear reporting your first file any Or time study investors

Eric Dube

Joe, thanks so questions. much for the

of we data as accepted is communicate, would submitted be additional interactions to once it's given on for trial receive So trial providing focused have probably the our the we're maintaining would to meeting, to that plans not following FDA with disclosure or it's any continue on that large plans. that eGFR we very part or once assume we we're cut, be is be be by and safe to to integrity. working FDA, going say, what additional part I the that going blind and Really, minutes, the on focusing And that NDA. the we in ongoing. any

But with FDA going us additional comfortable working at be those going we see at to they so as focus And to is that be are we're that I've our as with mentioned, look data. to really what point. disclosing

Joseph Schwartz

And and for And the agent lowering world? the market how of physicians undertake community would to Thanks FSGS is lowering likes the the treatment nephropathy adopt education important see who you goal then proteinuria do patients? uptake much how is awareness a most ready to rate an How still encourage sparsentan? in in IgA the color. and of proteinuria appreciation to you real strong in the need order Great.

Eric Dube

I'll that Peter Noah have answer and Yes. both Thanks for question. that.

that what much and provide community. research broader want they you is on Given team working nephrologist, are Peter’s bit start? hearing. market some his a team on of to of can the Noah Peter, top the a of lot with very a and nephrology with feedback they

Peter Heerma

And for well predictor questions. what Yes. we are also as proteinuria learned the and leaders results doing, which from market sense that proteinuria Thanks, Well, of how we of the Eric. market monitoring the thanks they disease. thought is makes often Joe progression well that the because patients have is initiation treatment research, the as of is speaking, strongest they're which think

if you risk that. to well-established relation a Noah, don't towards is disease want I there of and higher on think build upon I proteinuria know understanding So its to of progression patients dialysis. in particular

Noah Rosenberg

Yes.

I right, think that's Peter.

immunosuppressive are drive concern and toxic and aware they're case the acutely I therapy. of for proteinuria. AdWords in will an dialysis, We worsening outcomes that nephrologists effects all ultimately physicians the aware think the the time, of need of and of speak specifically proteinuria

where those around a think have go, targets, now. we in comes they is, now limited where options it because targets, educating additional therapy, potential education around I therapy and really can until that realistically had the such it's

fail choices IgAN, ARBs create they don't limited Immunosuppressants in for are very can concerns often they are Specifically short-term we that and and very work. treatments, around their know limited. instance, often ACEs, your in

have chance set that a the by better safety that and the them been works, some mechanism there how the sparsentan, it sparsentan it's awareness drug think message targets I of around important really So we achieving out like these there's of that get the data set realistically guidelines. out the with

that area an certainly that's focused So I we're on. that think

Joseph Schwartz

good. for best Noah. Thanks questions and wishes taking my to Sounds

Noah Rosenberg

Thanks Joe.

Operator

Canaccord our And comes Genuity. you. question Michelle Thank next Gilson from from

now is line open. Your

Michelle Gilson

agency if know eGFR different for also was for I specifically and priority you changes we curious And IgAN, for your could there I meeting. more I past what taking I Thank IgAN. I around can in And earlier FDA the focused the heard timelines you in most discussed analyses evaluate pre-NDA you presented kept And review were Hi. was meeting? I my bit more that provide wondering eGFR think done slope. allude color to was little pre-NDA that are that to during a discussed I guess just the ways what question. and on? that your you if And

Eric Dube

would take Bill, you questions? those Thanks, Michelle. like to

Bill Rote

Sure.

got all down. think I I've them jotted

as the interactions. agency a for to of presented As pre-NDA interim the book was briefing what summary far presented analysis. comprehensive the The

different split level, So a or primary it of events. ways. then is safety both by adverse MMRM, some was additionally, And observed time proteinuria endpoint. versus eGFR measured groups and summary review multiple which and the express different analysis at the ways

how So that the was presented. analyses were

around Until to this for ideal game. request that's NDA case it. granted priority we But an won't to ideal an Your this certainly something it. submitted gets of And we see know review, this that quarter. we've question. We after But priority the that the case as answer the the first stage in not question at review. for that believe is intend we

Michelle Gilson

can that Okay. And, as I one, niche if unpack well.

higher different it's levels -- And dose at or dose another just another dose it's And that indicated if if dose doses? I'm evaluating that if You're you've curious you guess, expect I level. you'll now. just, evaluate different level, evaluate you intervals may

Eric Dube

Yes.

at levels. We that, this looking dose study, within both have said and we're regimen dose

next do the with December. make see we what cohort in the data the on will we're going We when decision to

of either of the increasing dose amount staying be could and the those, current at could at it of the level. or level experience So same it be

to data be going decision, interim So blinding this at in once a year. later on we're driven it's

Michelle Gilson

a any higher know, I up with a -- here? I just it -- evaluate could you going there there volume follow-up, if any I dose? guess are dose in is subcue If do Okay. issues is

Eric Dube

to on much injection. So how limits are the individual there subcue tolerable is an

ameliorate split issue. into As increase depending be injection, the you volume ways to with the easy deal are or higher to tends doses the to if higher subcue of one going But multiple between a and patients. injections the becomes to is that that the are what's There that you acceptable there. what's It and patient with. on you can limits need dose, working patient with in of balance agent solubility

Michelle Gilson

Thank questions. guys much Okay. so taking you for my

Eric Dube

Michelle. Certainly,

Operator

next from And Liisa ISI. comes from thank our you. Evercore Bayko And question

open. now is lien Your

Liisa Bayko

Hi. both in I are for guess congratulations Chris Noah. and order

So been data. getting think the of congratulations a bunch questions And you question on much investors are when going on like some of is preview to lot a you been And And how just main we've it. of kind I've HCU. both. information I'm doing do to I fielding get work

you terms can what of response can appropriately and information communicate, you're elaborate of just how get maybe know patients? like, you kind you what are going to seeing of kind in expectations for in So too you're much how set

Eric Dube

assigning are on of Sure, I'll example, for course, And, areas know, HCU. that effect at, often those looking of one measures of within response homocysteine. total again, on magnitude dose that you take other three focus, our that assessed biomarker is There, safety is a we're Liisa. of and efficacy is

those of But provide So on be clarity questions, sure to well. we're those at as is we yet disclosing committed to how at going to read not we that make to have whether out. data going aspects much the expectation each we're we that that we've say time. I'd data be looking once that, want

lose certainly of and we there's something if efficacy, whether really Given regimen to that, also dose and competitive that believe we pursuing. we not that space, to dose, so want have understanding good one as communicate we're to the believe this we more that what much that sure is, want that, is make But we dose have that a have space. could in want providing wouldn't we so right dose. be that that the to a lead we we make sure We

So those a will on qualitative update well a a very we're three could each questions, at to provide, data. said we about minimum that that's in of thinking provide of how but little We a specific it. position more bit be

forward. As we go

Liisa Bayko

of And additional kind on any timing? color

Eric Dube

that later to on be near. to provide year. not But we're do this so. be But update narrow track Well, down at say, to to point that would further, able I we're to sometime that able just very we're even

Liisa Bayko

of look And Okay. be least want just big as program, as of you actually tail, Can pretty valuable about revenue like far of at on and an maybe it, more opportunity of I relative because benchmark? provide value, then it in as it actually. its could could some Santen. opportunity be on valuable the size think finally, the terms long And to a, has kind the at how of same kind pretty a it as and dispersant comment you're thinking

Eric Dube

early think Well, I across we there oftentimes need and One the very dose, currently start patients into U.S. screening, these the the of Europe. these The that about talk are population, in few of XX% is diagnosed, patients patients that, responsiveness. are given certainly to undiagnosed, we that despite that, effectively opportunity, a states can are there's here. a rare the The that, are still go BX is responsive, we X,XXX experts are diagnosed They area. and excited which high believe there being be we other that high Vitamin are the typically not we a proportion newborn within this case therapies are very is while a But literature before and if there's there like unmet that areas adulthood approved, enough when high clear is really estimate of many recognize addressable BX. disease.

to need that better opportunity that think who threshold. understand, unmet and where still key there's is, we above there So is the

replacement in at So that, therapy. part that's we're say enzyme And, it's big time. going a this development be of, an of to what doing to clinical parallel I'd

we this that on in there. really focused significant development, what that assess and are for bring value to ensuring is a continue lead for us. what we'll are pricing are and currently we do benchmarks So, But And, position. the believe we first opportunity we

Liisa Bayko

Thank you very much.

Eric Dube

Liisa. Thanks,

Operator

from you. question Barclays. Gould Thank our next And comes Carter from

open. now is line Your

Unidentified Analyst

taking congrats Justin is progress Carter. the on all on question quarter. Thanks This and for this the

program wrap-up Just you criteria what on understanding of decisions. to you of is on badness, of a earlier, us sort be show data to tape on mentioned want to forward key reader. response data in to out revealing know one first you on any if How next can forward how waiting and going going much sort us duration duration expect wondering, impact much the of, data for program. be be But to expect we going the just duration sort on to more you're going if the move Eric, with quick readout? that this you of that's And steps before that, don't your too tell you in moving your you should

Eric Dube

going talk I'll terms about trial we're ask design a of little at to will Yes. and follow-up. in bit Bill what the looking to be allow Sure. what

Bill Rote

Yes.

duration the from patients from double to continue open-label those a have interim, we'll data but a up perspective, in weeks, from extension. through XX everybody go on blind So then in

that. time for patients windows So will longer of for many the have significantly of

metabolic disease as you ascertainment. often longer with with degree endpoints, there's true variability. of window So what aided and of That certainly biochemical look a or biologic is a is

designs So the for strong trial very that.

Unidentified Analyst

Thank Awesome. you very much.

Eric Dube

Justin. Thanks,

Operator

Instructions] [Operator Lugo comes Tim from Our next you. Thank from William question Blair.

now Your line is open.

Unidentified Analyst

this Tim. is taking Hey, guys, [ph] the Thanks question. Watson on for

on the the the Thanks. applications? well, So if you choosing the And is? them? EMA bit And EMA their you I a the infrastructure idea submitting the ideal combined what Europe, makes that? application, partner of discussed partner feedback what's just process them Eric, on maybe with for provide you on Why wondering, could then more have behind as color BX have that the

Eric Dube

Okay, sure.

for about so really ask on the our a the And our first our much Vifor Bill how So I'll to little thinking talk EMA. thanks bit to partner. questions. as Watson one select [ph], more evolved take with I'll engagements the then

and within Europe set about with collaborative, have is someone has it really the we the some launch experience just top partner think the to countries standard like Europe focus regulators bodies, that us, ensuring going So sparsentan. and for new also optimal important was we Vifor as of level, hospital when Vifor They about within the treatment very someone KOLs. having practices sparsentan assess great think in some majority very to the and reimbursement which to just that's I going making in who that we had not access. of within And led what clearly with just has, thought all have looking of but in an be thought nephrology. presence at think they were HTA established And have in or And of us countries value with when about it's also certainly found about on Spain local who's nationally, regionally with with a Europe, we the which and relationships of and important for. we nephrology nephrologist out relationships the working then not sparsentan it's partnering not the that to with but we also

with felt not it time there quite for bit is that that ensuring decision, like education. the for but we because so, dossiers done, ensure from to of needs work we just the also And that organization, prepare to the right make filings was us and to a HTAs regulators, be and infrastructure

nephropathy of that that launch. for that same FSGS. does in foundation we in think And really de new great Vifor. as think kind so IgA I really executional my led with in the goal to that exquisite treatment making sparsentan to I organizations place of a two decision. And alluded with think that's And making risk and have, that with we any comes focus the what And that we what prepared us risk we're is comments,

hopefully that we've Bill, question. how I'll And So file your that with turn EMA. discussed to combined it answers over the you on

Bill Rote

to of analysis align Yes, our aligned the schedule submission, go for certainly. and Thanks working there. Lachlan, they're discussed to meeting the the approach and with the on aware pre-MAA the the we're but the EMA with we have question, data content current through and so We're the they are at this and for combined time decision. go approach with interim good to align

Operator

Thank you. from comes And question Laura Chico from our next Securities. Wedbush

line Your open. is now

Laura Chico

second. I I missed regulatory I or for But of just if to Thanks question. a with question the strategies. apologize US contrasting a European had very the had taking the And versus kind off for drop much regards

of European the it together sense advantage first quarter in filing case. I'm just thought if I submitted US that successful could not if an submitted these submissions DUPLEX, heard there curious be to I'm say, correctly, in XXXX, things these make might could be So, I data to the in was understanding in from XXXX. file you together with why settings? though IgAN FSGS the additional the the middle

Eric Dube

Sure.

it's our that. to is ask So talk what's -- as ultimately both driven, And out how population strategy Bill? possible, that's this as regulator for agencies what really, can is allow what we regulatory I'll Bill to get pathways. a quickly And broad about really

Bill Rote

have with need that mean, a and trial XXXX nephropathy then two period the for In have in what FSGS and the the I the and strong in we months from Certainly, basically order the to don't clear that to can IgA nephropathy between quarter additional support is we in data, filing eGFR it's offset similar From very leads forward, of we a We with for a IgA review that wait results U.S. active to to NDAs. wait pathway submission. a our hold very standpoint, question. extra logical in agency interim and PROTECT of the filing reference want and submit parallel cross the FDA, U.S., do or first back slightly

we a do system, which the can isn't that. there by mechanism Within European

trainings, the two, optimize that patients, the the we FSGS we way, reviews, to one nephropathy data either. we have review by allows available, that or are did to two the strategy combining IgA before us it, there do didn't and up parallel we get in number the most next that largest we'd be the if once with different end So the start wait sparsentan If to we completed can to which quickest -- ideal geography. for if isn't of

that So in with strategies geographies. for this is data same rules the their respective optimized two really are the

Laura Chico

kind apologize IgAN I kind position with to this delayed? helpful. What can risk you. of or being been their is potential quick the change of And one there to agency Okay. follow-up. up Thank if FSGS? asked. again, submission submission I tried And to for the to the has in That's sync reviews? US combine sneak the Is

Eric Dube

Bill? Sure.

Bill Rote

down are to two that resourcing is and NDAs. point, two the indications fact Yes, development, indications, which to the and prefer one separate, and do, keep their about by and Early one that combining the that to at we separate driven one how will lead two don't two INDs, see this how NDAs. how asked NDA, they to happening. many able they justify reviews there's many -- of into Part I two IND, in comes they metrics

would So, a it help all reduce want any I timing FSGS. doesn't from number it them, the data had on of fight a NDAs we've to perspective. see for discussions them indication they they from based if don't that artificially, but also with wait in the resources, them decouples the for that subsequent

Laura Chico

you. That's Thank very helpful.

Operator

questions. I'm you. showing Thank to now turn Chris I like closing further back Cline for no would remarks. And to the call

Chris Cline

Justin. you, the balance throughout I afternoon this all thank hope you you Great, update. concludes further great joining year. the our updating Thank to have evening. you us about all to And a quarter This forward third for of progress. look talk our We

Operator

today's Thank You you conference disconnect. concludes now This you. for Thank call. participating may