RTRX - Earnings call transcript Q3 2019 | Travere Therapeutics, Inc.

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Operator

Good afternoon ladies and gentlemen and welcome to the Retrophin Third Quarter Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions] And as a reminder, this conference call is being recorded.

I would now like to turn the call over to your host for today Mr. Cline. Chris

Chris Cline

our Rote, Development for our Kirby. financial and session. and our the call. be results will President led you, Research third by to Today's and Senior joined join afternoon Dr. Noah be XXXX Officer, quarter and by Good thank remarks Laura Eric us welcome everyone Retrophin Q&A Officer, prepared call Eric Chief Great, Dube. Executive will Chief corporate Medical Vice Financial the Dr. Clague. will for Officer, our Rosenberg Chief Dr. Bill of update

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

are from They performance, implied actual expressed cause and guarantees involve that and materially statements results, by uncertainties, statements. not performance. differ known those assumptions to of risks, unknown may the or and achievements Forward-looking

disclaimer press Please in forward-looking the as and Form risk factors SEC. release as today XX-K see well XX-Q statement issued our with section earlier the the the on filed company's

In October disclaims any information, XXXX are the statements date Retrophin forward-looking made circumstances. to or as events, our update statements such only addition views specifically such to any of future obligation and statements XXth, represent reflect

that, let With me now over to turn Eric? call Eric. the

Eric Dube

everyone. afternoon and good Thank you, Chris

changing therapies living fulfill continuing to people our important delivering mission to are life developing, rare We identifying, disease. of with and

the During portfolio. the our execution across pivotal development third our commercial programs and solid quarter, teams had

goal in our Phase continued we advancement progress programs, the of towards transformational the the creating sparsentan growth X With of coming years. made

risk are stage nephropathy IgA no disease end and of approved renal treatment FSGS at a with with high options. Patients

Phase am track for great studies programs act sense on X remain Protect both to pleased and to our of with I timelines topline meet continue we the data. pivotal the and execution So, DUPLEX on with urgency. of a their

now support to the of Study of have than key talked DUPLEX open enrollment call, pivotal more centers about quarterly We initiatives last the excellence we our sites for FSGS. beyond XXX On DUPLEX implementation our the Study. in in

resulted Most and in importantly, our positive efforts the engagement momentum enrollment study. in recruitment for site have

We also our which a for targets. to for achieve enrollment, as confidence indicator leading in change us screening, positive trajectory gives seen ability have a in our

study PROTECT XXX,XXX support a U.S. its Our seeing and addressable and the treatments continuation are trends the potential IgA Europe. the expand nephropathy, our of there the enrollment patients strong in If in s well. robust maintaining population we as sparsentan for than more from has to to approved, community

business, we patients On product the new We growth side commercial portfolio our saw initiate is performing to net organic and delivering of plan. of record the treatment sales. continued track in our year-over-year

disease continued Importantly, we that patients' listen We rare ask. we to our growth and needs our ability patients. in and new patients to our vital to know and is organization growth is identify reflects consistently team's identifying successful because physicians'

THIOLA EC this. example a is of great

Thiola provides the reduced was EC burden, that patients a could if a and additional that Our find administration treatment freedom treatment for option, belief would potential offer pill choice. meaningful of we

We access this the are months clear and the launch. three of strong in evidence first with seeing of demand

engage with of our are than more demonstration by to a payers. for prescriptions This point, of and Thiola our launch, being in is EC successful covered XX% payers. this a line ability At effectively expectations

those original amongst discontinued who We formulation. seeing the broad patients, are including also uptake

with not number previously of in convenience available try a of these the that was additional hopes Thiola gaining seen have formulation. original flexibility We and EC patients the

a meaningful area option these that All patients. from will signs of Thiola confidence system EC the product this launch early give us for be

guidance us expected launches, continues our strong commercial for reach quarter Overall, team and delivered that the Sparsentan. also The to keeps our year, acid our future perform third with ability showed to successful a be track growth. portfolio and including as bile year-over-year demonstrates to on

the therapeutic with also and first cross-functional will and organization. area, more want optimizing the aligns Noah well our hand Sparsentan instrumental Peter's has to as call we be than the He a best-in-class Commercial clinical in update, therapies position Sparsentan over U.S. appointment deep and top strong Heerma, patients I commercial the accomplished building to company's as leading shape IgA Chief nephropathy. XX years the of experience to of with at I FSGS appointment treatment Officer. He abilities. commercial in leader value experience, priorities launching highlight before directly and upon highly teams in Finally, abroad, as for nephrology the for paradigm of which the Peter is our recent

over Noah. to Now, let call turn Noah? the me

Noah Rosenberg

you, Thank afternoon. and Eric, good

development This patients will with progress, that Sparsentan subsequent our these made kidney It clinical in in of of progress by evaluating is advancing and nephropathy, these IgA reduction function XX% requiring teams have transplantation. XX the pivotal proteinuria. to progressive to years Our and and FSGS IgA tissue, filter nephropathy renal in dialysis quality defect both of life leads solid disorders diagnosed ultimately XX function remarkable within in anticipated decline a familiar characterized failure or renal loss in trials, XX% years, rare FSGS life to are functional expectancy. of to

progression for indicator need With and improve for is significant a these or stage end to approved patients. unmet treatments EMA disorders, renal no FDA to delay outcomes pharmacologic there disease

the as IgA goal Our first-in-class FSGS ultimately and disorders. to the patients Sparsentan kidney is in shape ongoing with a therapy, these deliver rare paradigm with for nephropathy programs treatment pivotal

to in in a enrollment to initiatives which our drive our quality effects studies. once believed our Sparsentan clinically potential treated studies. Phase protect patients renal XX meaningful pleased compared after and and in when have duplex irbesartan that weeks I Sparsentan great us teams meaningful unique in am are confidence made ability reduction structure progress treatment the on demonstrate on to operations with outcome dual gave of to mechanism FSGS. III This blocks angiotensin continued and detrimental report, and and selectivity stimulated lead and to receptors, clinical proteinuria both profile both, endothelin

both Most DMC independent second planned and recently, meeting and our recommended studies. Committee DUPLEX as PROTECT for to Monitoring both with proceed we the completed scheduled Data

study DUPLEX to open than outside for presence. our we seeing have from activities. been engagement screening, is now reach in for important the also the continued XXX with broadening which we our and in have Centers milestone our results of sites site expanding For the an patients U.S. FSGS, are more the Excellence I encouraged

we tries highly site operational positive productivity. a engagement have with knowledgeable seeing further traction a continue interactions team focus and Their and a We have quality. primary clinical site scientific enrollment with on to ensuring and that are impact

the enrollment and having we half intended which have data our are to initiatives Europe. DUPLEX XXX will impact. for top first line Overall, anticipate we And support XXXX, patients the track approval in the remain the U.S. submissions accelerate both of first from in on

program sites For about with have the and many We been study been has for open with of patients our open this months the nephropathy which XX approximately progress. we've and IgA footprint Duplex. enrolling shared PROTECT are from now screening XXX for very pleased benefiting

XXXX. we ASN community strong protect results confident the the a half line to Week We upcoming nephrology Our of look deliver at ability the week. to result, as in with and in forward engaging top the enrollment Kidney for first trajectory meeting remains remain next

in approved upon new as potential, nephropathy. and standard growing to become Sparsentan on support building We will the future the treatment focused if IgA FSGS be for

to addition studies, our In be of the two of Sparsentan research raising some new in pivotal ongoing program highlighting we'll a awareness presentations. from poster

study. proteinuria and to reduce reported meetings has demonstrated Sparsentan at stabilize treatment previous ASM to ability out an we've As DUET of XX open-label weeks in eGFR

community. about findings is to quality another disease. extension narrative encouraged Sparsentan sharing against for FSGS growing supportive from open-label with two more are background life of the we show maintain piece their to This than to that forward in patients receiving new look Sparsentan the We progressive years the of the

also in part to of the nephrology Sparsentan continue our heard reported signs syndrome The aspect given Alport patients their there maximize And physicians collaborators. early, potential as the function. of this is may efforts address have to while As which a be need builds loss, preclinical hearing potential will from Sparsentan potential that as meeting impact the encouraging discussed on disease. potentially and upon reduce Sparsentan the have to with are previously Sparsentan kidney to have the work for we positive our explore to preclinical rare

the to pathway as we feasibility continuing in we'll are share development elevate Sparsentan and the and in We assessment. Alport, progress for future more our

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

Laura Clague

Thank you, Noah.

product from $XX.X net grew X% commercial increase sales our During in third XXXX. same the portfolio period quarter over million, the a

nine the first we remain our guided net the and $XXX.X sales we million for product reported XXXX, reach track year. full to on of growth of For months

net of quarter income net XXXX. we expenses adjusting GAAP loss million. tax, of loss a a reported for reported million of for $XX.X third the non-GAAP $XX.X non-cash and After We

million stock-based basis, quarter efforts. included quarter. Relevant third were the expenses third The expenses support for GAAP $XX.X and On basis, for to a for the is product same our development of the expenses quarter higher million R&D of were expenses an On the increase attributable million clinical XXXX. in third adjusted to largely amortization. non-cash R&D period compensation X XXXX over $XX.X and

million. for Selling, adjusted compensation On SG&A administrative adjustments non-cash Significant professional XXXX over consisted quarter in increase for the expense quarter compensation The increased depreciation largely were higher general same stock-based $XX.X attributable third and an the amortization. and million million. non-GAAP, of and $XX.X and the for to expenses in period expenses were is the quarter fees. $X.X basis

during of guidance associated a Consistent the to program. program of CNSA-XXX, that million we with long-term period with XX our previous a joint incurred the investment impairment discontinuation related with development the

quarter continue we and to the reported complete accelerate as fourth work for and similar we anticipate DUPLEX expenses to PROTECT we quarter, the operating fourth this ahead, closure. study activities be in Looking as what to will

we operating from anticipate XXXX, decline will levels. For that current expenses

spend given current the SG&A a we decline in the see We to XXXX, we in modest decrease the of of and anticipate our discontinuation anticipate full R&D program. our fosmetpantotenate for it will expect reporting incrementally year what state overall from XXXX, from

We cash $XXX sheet disciplined equivalents as in strong of are cash our our maintaining quite with XXXX. of investments a and million September balance approach to XX, remains

level Importantly, beyond sparsentan planned support our interim of cash will DUPLEX us balance study. in allow we the this anticipate of to potential growth current operations invest the readout and

closing Eric? back to Let me now the turn his for Eric remarks. call

Eric Dube

Laura. you, Thank

well-positioned we building remarks, team's the are vision. towards from heard are positive and advancement momentum for you As our

during greatest quarter to decision our to the and shareholders. key the of for program, value patients expected we've create to our to and strengths chances on maximize the success focus are the our fosmetpantotenate our discontinue realigned and organization that the Following priorities

to through value the optimizing transformational As financial execution foundation and we we four our with leverage priorities. on our strong going purpose, of clear ahead are move key focus

as possible, quality quickly successful maintaining We as the we today. conduct seeing enrollment the study will PROTECT drive are strong while pivotal DUPLEX our and of studies and

We potential will opportunities to evaluate have additional may for explore patients. work development additional for sparsentan

We portfolio sparsentan. capabilities of will potential successful full continue approved the to launch ultimately teams to prepare building and strong upon our our of for realize product a commercial

And we finally, and opportunities the on we will focus our our in value create growth prioritize can diversify near-term. meaningful remain in development potential to business disciplined that believe

team position of dedicated are we and balance to employees as sharing we execute, each and throughout of move incredibly on our in Retrophin XXXX Our XXXX. the is into and to talented at these priorities forward progress look

to Chris. me call over up let to Now, for Chris questions. the it open back turn

Chris Cline

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

Operator

have couple Absolutely. We Instructions] now [Operator of a question.

your Schwartz Joseph line comes question of First line of is Joseph now SVB open. the Leerink. from

Joseph Schwartz

terms those Great, thanks their in other or patients very the severity on detected baseline non-centers from is where congrats of the or those type difference now baseline if terms progress. difference towards characteristics anything in you've of in sites sites any any that you excellence I of like were getting wondering the being referrals type there patients else? or the enrolled of being FSGS of referral was with primarily and are characteristics driven at earlier and of much

Eric Dube

Joe thanks for question. the

saw we the Study we're the do and think strengthen looking the to results in and ultimately protocol for studies what to we is importantly, across see from the I DUET Phase X. consistency that replicate

his seeing I'll we're thoughts what to on far. give ask Noah thus

Noah Rosenberg

that's no, great Yes, question, a Joe.

we me are we Let Data currently obviously Monitoring Committee. data had set just -- just our that to blinded the and say got we've

the versus main so something by we -- that And out but don't in is broken centers, stage, look at at the we will haven't certainly we community this the that future. right, data

consistent had with we that we with can able the they've think recently are and say data being I at meeting to the And important we that look and what DUET. point in overall the in a have of well a a past number different DMC we've as level blinded the been parameters, seen

I much I think as can as say. probably that's

Joseph Schwartz

are then new inform learnings on notable most going helpful. or can product surprises Thanks. that what market? forward? the the in points are aspects Are of any the you that's profile the any Thiola X.X, there And Okay, and found that launch resonating

of capture then previously a you And were to Thiola mentioned back all coming those are can would that sense represent of the you what X.X? us that woodwork, could somehow out you lost some if give opportunity who patients patients

Eric Dube

Sure. Thanks Joe.

before we the with to being patients think important with aspect without Thiola able with heard of launch. regard are as product that the therapy hearing or that well with did the the flexibility physicians I a the food. aspects overall market we was that as that and EC, And the in of very patients to research development of we're take the pleased

patients number forward We what the seven patients on patients for that over the important anecdotally, reduced we for of the see a currently majority therapy proportion the not expect that Thiola a of in patients identification growth Cystinuria think also past, And can of thing And given in that continued patients Again, is we commercial the it's time average And Thiola that that are that discontinued on broadly that's per new a thus it's burden patients what new teams we has the to of in And over has by seen focus those that our move that we're pills treated. patients pill the portfolio. to That's our meaningful patients hearing to years. segment focused that on been now. those growth EC. know be with last we're we patient for to that launch. of have but takes we them on focused many our it's been early regard engage, as, challenge. want seen and a the far. largely few the continue And we've are day the with

Joseph Schwartz

again my taking Great. Okay. Thanks for questions.

Eric Dube

Thanks, Joe.

Operator

Liisa, next line Securities. Liisa of now Your comes your from question line JMP is the of Bayko open.

Unidentified Analyst

Liisa. Hi. This for on is John

Just a sites as how the And enrolled far. consider many couple wondering I'm many you have how questions quick on of of centers you enrolling so of XXX patients would DUPLEX, excellence? could

Eric Dube

thanks John question. for the

the timeline provide we are with So commented not continued patients enrolled. of on is on your for DUPLEX And data that Noah that number to hand be reporting we've the for rest to the answer first the have guidance of of in achieve headline progress able pleased study of half to have What readout to of and the we very I'll XXXX. questions. to it over the

Noah Rosenberg

the think really clinical sites of – centers on referencing And sites. be program a over these of are centers that There one there of two majority really the we've question learning's of The XXX Nephrology percentage foundation about of there community to which up to most academic on was these of had key there key United was registries sense. centers aren't the is excellence. excellent, X,XXX considered Nephrology the centers for I is then of Yeah, are out sites. makes And research the States centers. academic. excellence was broaden the If would connecting in community are what – I that and the about the this

Unidentified Analyst

how on able you're many blended to many Florida for That's to any dose basis, down pay and higher how have make patients a you helpful. color dose? on And the do then are titrating

Eric Dube

looked that accessible It's don't we Data something Monitoring Committee. that We would this be – that to data at at have haven't the stage.

we basis, that. haven't can see rephrase on on commented actually a me Let blinded but that that. We

Unidentified Analyst

OpEx think just said quarter. you Thanks. you the somewhere including expect this for just quick We question Are R&D be total or Laura, And XQ you OpEx and impairment XX to and million R&D. to saying I SG&A believe clarification in you SG&A or one are in also asset?

Laura Clague

out. have Yeah, carve to and R&D we're kind of that talking just really about you that one-time impairment SG&A

QX be item for the item line of R&D. in So, the levels similar versus QX line SG&A will

Unidentified Analyst

Thanks, again.

Eric Dube

John. Thanks,

Operator

the Jefferies. line now question Raycroft next is from Maury, line of Your comes from open. Maury your

Maury Raycroft

my thanks by upon number forward? To can taking that and Congrats start going mentioned being Is Thiola questions. for EC, that on a for improved you covered everyone. payers. the XX% Hi, progress be

Eric Dube

for thanks question. the Maury

So, by that received that Thiola of prescriptions to claims to approved of we're the adjudicated would payers. number we've Certainly, for number the evolution expect have referring EC and continued is been that. you see

the I that think really Thiola difference what in EC. looking is and access no Thiola for we're ensure us to there for

to track as looking of or able first sign is the XX to at achieve percent having very launches XX lives been in adjudicated days that launches a access strong prescriptions recent on and we're I've think, with plus as I of in assessments be prior well familiar covered of for that patients. very

Maury Raycroft

size proteinuria any that can the with DMC and Got DUET. guess, it. more else? I something data to whether from there or you And date of the mentioned provide referring you're consistent you clarity

Noah Rosenberg

safety add think, significant messages, milligrams Yes that I a the of I'm the terms on not is we're what color. XXX seeing we at I really data can with I saw guess also mean, basis. that that from get obviously coming milligram, we're more saying I a a Maury seen guess, consistent say, baseline blinded key clarification I'll look the XXX little bit concerns And question, data seeing there. the dose seeing, a DUET. we've I we're it's that just what in, overall, safety in we can of issues on and or of what any

as Committee well. this that's in message study. supported Data from it's green the also important at most the by I the Monitoring So, And think the stage light

Maury Raycroft

in for trajectory are doing for so if what this referring is the Got screening you're that change you improvement And more sites? front patients you a helpful. of screening screening that differently on failure are That’s seeing, in to result improvement it. rate. an for just the or the DUPLEX positive having And then

Eric Dube

really a question. good that's Yes,

of and sort level improve trajectory high what talk here. the me Let the confidence timelines about we're doing in the to

So, really subtext think your the that's question. I

that I part of and in timelines based are We confident as is am -- the on leaders FSGS.

realize is As was, are and DUET, an from we you underserved field. pieces that you put really standpoint. largest right know, standpoint this key to mean, DUPLEX study a establish I place both research what in is this what some learned an there clinical in from the awareness area, to need we in

those I think active we've the So, the ensuring engagement this that we and we're both of addressed challenges, time, why inflection takes sites, that community is those with the seeing there level the is a and solid way getting and getting it, setting in foundation sites, have a place, right Maury. sites confidence that up at a is physician

there. you are its engagement, job led registries. the that's referred what think As to we get the the to good then re-engagement, community that ensuring patients engagement, in sites actually, the connectivity that And physicians an of aware and that's their are sometimes extending the to, increase really has I to to team its And And study. in of importance screens. study is the the of know, that to aware a and both out and increase enrollment done

rate down they definitely screening can and somewhat seen that, I the and they -- patients the just are sites techniques in-house. train, would develop and probably learning I we've better as get that because And is come screen I think right the say fill

and the in of those first the of data combination XXXX. a really is in the to confidence main half it's first given half the increase and us think ability execute -- really the message get recruitment of I has our in but So,

Maury Raycroft

for taking Got Thanks it. my very helpful. questions. That’s

Eric Dube

Thanks, Maury

Operator

of your next Gena from is from open. your Wang now comes question Gena, line Barclays. line And the

Gena Wang

follow is enrollment questions. Thank one what question, XXX taking This the you. for already Thank Maybe you my just enrolled. wondering have portion of Gena. just patients

Eric Dube

Thank for question. your you, Gena

the So for that in we guidance comment our timeline on don't the focus readout. progress is the Again data rate enrollment the seen. on and we've

the to data absolutely track in we of able half are first on So the to deliver be XXXX. headline

Gena Wang

Okay.

in So order by expect patients to to say mid-XXXX deliver fair to say of be able the data? is you it enrollment XXX

Eric Dube

absolutely the that's think I case. Yes

you time clean about required and be are that If in the weeks the think and XX then able to data. to analyze study the

Gena Wang

million is much this another Okay. regarding Pharma And from generation? from first for question much $XX.X Thiola EC is quarter how and how then

Noah Rosenberg

question the for Gena. you Thank

we're out. launch So we those the of are later. reporting to may reporting out position in not point this both But for brands consider the do. this it's At at point doing a that revenue in not combined we're early we it's that that breaking something

Gena Wang

it fair say majority So from generation first of revenue the products? is the like is to still

Eric Dube

really a position that to detail do. not of level Again in we're

three If you quarter as the you think launches ramp a know And period. for up many that reflects of is about there two only months with launch.

So out want with it's set it's to you majority early especially break precedent starting to where can imagine launch. don't a in but the we're that those of Thiola I

Gena Wang

Okay. for Well, you taking question. my thank

Eric Dube

Thanks, Gena.

Operator

line Kim of Your next question Do BMO the comes line is of from your Capital open. now Sir, Markets.

Unidentified Analyst

this on for Do, for my quarter. Hi the taking Jason congrats questions thanks [ph] is on and

question, how your you. very versus do and you this So is how your pipeline catch profitability strategy. development just general all you Thank business about broad-based think about think assets going about general forward do thoughts acquiring a

Eric Dube

in development ultra-rare continue within pipeline. as do our and continuing the one of to we spaces. our Sparsentan A business of programs So portfolio continue well. We'll development and opportunistically to diversify priority. I'd to strategy that say as the certainly our really top our our an want priorities important rare execution the remains look outlined We is

make that areas. very in we of much and would aligned strength therapeutic bringing feel think strategy disciplined. don't on do do of with make we set is Retrophin very value we the we deal We approach we near-term bring assets and the do want to that a rare deal in do be that the and and deal that creation are we any that any want and leverage and in sure that focusing opportunities ultra-rare Importantly there pressured in in of sure to kind to for that our capabilities take broad

use we that sense gives for the our looking programs. a thinking about bring execute cash sensitive not our the hope and in, and what us And at certainly ability assets a to price. of compromise sparsentan we're to in we're business development, on stock to better you way to gives exquisitely flexibility this I the believe current at of that the position

Unidentified Analyst

That's great. you. Thank

follow-up. quick a Just

the looking terms for you are early-stage assets, In late-stage, commercial? of

Eric Dube

Yeah, great mean, I it's but what opportunistically aspect. want a question. the it's I would more strength this lie, we of broad, the you if look of about say in is part organization do commercialization think where to late-stage development in

We or probably prioritize have opportunity to efforts. will those of bring build to the And to having we capabilities. significantly without invest in distracting new where that's most our

Unidentified Analyst

Perfect. much. Thank you so

Eric Dube

Jason. Thanks,

Operator

your And the line your Marai of Christopher line from is Nomura Christopher, open. of next question now Instinet. comes

Christopher Marai

Great. launch, you any might EC also for directly I EC? comment THIOLA to THIOLA could taking ask moving seeing maybe to impact you on Hi. the question. THIOLA wanted or on just be patients Thanks about positive now scripts

you THIOLA such correctly I if you a not And may looking strategy any over or have panning out of then switched move this you launch to perform pursue to launch where think sort recall follow-up. at is want that indications potentially point EC, I patients were the in a type I that a secondarily, organically? THIOLA to

Eric Dube

questions. for Thank Yeah. you, Chris your

regard with to First, new patients.

very pleased for seeing to on cystinuria We patients that of treated and including the coming new new are patients we're with THIOLA progress continued growth EC.

two demand about may from seen. have the aspects learn come of also is treatment look who launch existing certain EC just of of up are demand? patient signs the who to improve but sources the part those options, is, profile what patient patients new and we at not that as for patients THIOLA there the think I of might looking early And we're

approach. a of terms In the not that's strategy switch

here patients come may and Our is bolstered back commercial is our on acquisition, discontinued it THIOLA then be for therapy portfolio going have overall delivering to for we're coming that likely growth. we're growth THIOLA will for That's That to line new by we're strategy patient continued EC our from the this improved year us up and patients. year. in setting pleased that growth given approach continued with taking growth the and for profile next those that largely

Christopher Marai

respect update in you. Thank near ongoing term collaborations, respect you. IND potential and for Any us And to XXXX? just R&D Thank Okay. the filings with NGLYX your then ALGS. with maybe to the in those

Noah Rosenberg

Yes. Thank to give that. on comments for you those Chris seen ask his the with collaborations. I'll we've Rote Bill progress

William Rote

for Certainly. Thanks Chris. the question,

any filings at collaborations in there no. a IND where last be XXXX. triggering stage answer is at to The aren’t The maturity a Your point we're question events.

but of patients just on we'll off status. the more early research. ground had of the that's on lot NGLYX early to to and way the earlier an well have and stages with efficacy and discovery current actually very We stages stage, very project, a NCATS NIH teams future, as at and the the the and into collaboration our production find leverage The Alagille be getting so as of collaborations both efficient we productive broadly the organization have more bringing that in

Christopher Marai

important very and high able serves resources, innovation standpoint. a I to as for go but scientific from very a explore need of it to potential to be efficient with be model their areas think us into unmet

William Rote

any of collaborations guess these filings, any expect derisk clinical the programs? within path the do Absolutely. work to arise you'll forward? might material that able IND I XX from next your Points share to you short And months that the regarding be help

Noah Rosenberg

be going with would to But back discovery and to the research, don't. think come XX-month it's occur, we if those next predict I certainly events it's we where over difficult period. Well,

Christopher Marai

Thank Great. you.

Noah Rosenberg

Chris. Thanks

Operator

your open. Genuity. the of of Michelle Canaccord Gilson from line question next your comes now is And line Michelle,

Michelle Gilson

Hi, just of rare high a planned? from that then key into as talk maybe of level the what indication? And and takes for Can sparsentan, think proceeding the areas you're thank you Sparsentan on bringing looking you question. when talk at you my about can area it some kidney for taking additional DMC focus a them maybe you to for little the bit about recommend

Eric Dube

Sure. Thank Noah those ask you, take to Michelle. I'll two questions.

Noah Rosenberg

Sure.

I is mentioned concerning signals So, sure making on are carefully earlier, SAEs, primary at ensuring DMC are they focus the generally focused unblinded. events, that has -- as signals. there adverse -- no safety, And looking a

see actually don't have between really look what It's and blinded communicate. to DMC We statistician, at. they the opportunity the they an

actually ask pretty anything green really They so it's the can dataset. for getting And a because full and encouraging you light get and when they they're often do. everything

I DUPLEX, Phase that was we've as Protect course, and set that surprising draw good well. what a that from good know data for set study, for do we've signal And from and got seen to given got large some which both a with data clearly, safety not really and you've of you're to X us familiar

best probably I way -- the think DMC to discussion. summarize that's So, the

outlook is important experts that From of a have told we that us at valuation. definitely talking we terms they've kidney something we something certainly but this the encouraging on model, our to commit not proven function, endpoints, well stage terms mouse in From We're sparsentan, of to as indications, which doing it's as on and at from script of ready data and to to that's to we're commit. look each in hearing at the an finding and did the allude not really patients ready additional Alport. long-term upcoming in have we're to ASM, in

It's angiotensin FSGS common mean, share from that our these And the will the looking we're to we that, fill got which we're Michelle a standpoint comfortable feasibility some when other coming Alport is we back certainly and we've are say other longer up more regard opportunities beyond come on, open in they'll clarity of things KOLs at will we even with opportunities I question. of IgA there an too, at pathway when a both to I advisors looking you. and from are and talk term. great broader and and are things in this and again does general because disease. it with

Michelle Gilson

you. Thank Okay.

Eric Dube

Thanks, Michelle.

Operator

line And Tim Tim, is William the your of line from question your last from open. now comes Lugo Blair.

Unidentified Analyst

Hey, whether that this is on Sparsentan you Lachlan in of retention for data-monitoring talk [ph] before could are expect in just for or committees fluid the Tim. trials have you're interim more the I questions. taking more readout any Thanks And DUPLEX? wondering risk you the a little was managing the if any how ongoing?

Eric Dube

question we that I best failure we is fluid with retention, DUET, looking which question. did not see at way and well great -- of answer was heart think some bit a I diuretics managed see did to there. The where think

think was with as encouraging, that class. not some in failure I the of that the you heart extremely increases that very we at backdrop there that, retention have seeing specifically within fluid carefully. been our looked question We're so know because is days the And DUET

think a add couple me points let here And Lachlan. of other I

kind of look gives power there the studies data identify First at of emerging. the if to DMC to ability together, signals are all, greater and both

with the continuing But also So, the encouraging is aspects manage with the of that events able some progression on the adverse retention. they're of it to study. and approach fluid based DUET, to they're be protocol

Noah Rosenberg

that's think right, Eric. And I

this key the important them continue heard is, to these The manageable, the manage it question really it diuretic use, patients these is can with therapy. fluid manage able PIs is with going think think drugs. right? we've on to Is you're and I some that and see retention that they're I something

Unidentified Analyst

any the planned Okay, great. there the Data Monitoring Committee, on just are interim Thank And you. of DUPLEX? before more

Eric Dube

that future I are. meetings. can are DMC There there say plans

occur findings of what update and meetings they are. timing when those we you of courtesy group the disclosed will but, a let as certainly know the course, haven't We this

Unidentified Analyst

you. Thank Great.

Eric Dube

Great. Thank the you for question.

Operator

like Cline. are this it time. further questions back to There at to turn I no would Mr.

Chris Cline

joining This in to forward look progress. Great, thank today. We near concludes the you our Thank our Kirby. us updating on you, call. future everybody you for

Operator

to a Thank everyone you, who and our great you so participated much presenters have and day.

Travere Therapeutics (TVTX) 30 Oct 192019 Q3 Earnings call transcript