TVTX - Earnings call transcript Q2 2024 | Travere Therapeutics, Inc.

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Operator

Good day, and welcome to the Travere Therapeutics Second Quarter 2024 Financial Results and Corporate Update Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to the Vice President of Corporate Communications and Investor Relations, Nivi Nehra. Please go ahead, Nivi.

Nivi Nehra

Thank you, Rachel. Good afternoon and welcome to Travere Therapeutics second quarter 2024 financial results and corporate update call. joining. Today's Executive be Officer, for President by all Chief and Dr. you call led will our Thank Eric Dube. Eric will be Dr. by joined in the prepared remarks Jula our Officer; Officer; Inrig, Medical our our Commercial Chief Peter and Financial Chief Heerma, Cline, Officer. Chris Chief Dr. Research Bill Development us will session. and Rote, Q&A President the join Vice Senior of for

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

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

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

Eric Dube

giving which you, FILSPARI, continued is Thank second our becoming At hope priorities. good foundational progress a patients In on key for is quarter, everyone. a to for the and Nivi, afternoon, we our significant better of nephropathy, IgA make the growth future. therapy center

strengthen. launch Our performance to continues

year goals. which all high is regulatory strength only to quarter-over-quarter the track is driven and start and quarter, growth During launch we our sNDA of including full positive set quarters from and in and full breadth demand speaks FILSPARI by prescribers, process being consistently achieve our our are perspective, ability increasing strong factors, key our we a forms on physicians patient X and first the IgAN payer planned, of coverage, in for in review and improvements process. From continuing growth our of patients, as and depth trends continues new This approval and month. on outperform in pull-through been rapid impact launches readout to to our in the potential to the proteinuria demand through approval we interim has launch, revenue, educational renal deliver new in preparing highs rare from on benchmark and second eagerly promotional X. PROTECT. and date, profound the focus from our are To for next results

the launch would to that excited anticipate are reach from label momentum provide, label We about in conducted that to more would enable on broader educate a the opportunity rigorous including build to the the We an updated ability IgAN. data in further study patients. most us X-year

our the nearly kidney over Specifically, prescribing time since ready. FILSPARI's durable future population the patient are and and the addressable level, even teams safety to we it estimate data could provide X-year proteinuria in function potentially double and highlight long-term opportunity teams the clearly for conviction should FILSPARI in an preservation our will build reduction, from X-year long-term current data, IgAN more

We also of in to bringing progress world. continue the patients FILSPARI to in IgAN make other parts

the the expected Our to of submission pivotal to XXXX, launch region Japan, and results first second that to preparing support very partner Vifor in of their for in recently Renalys which is soon. for CSL a half study, Europe, FILSPARI regulators is dosed In patient Japanese the have approval. first in in

regulatory to regarding furtherance the the ongoing to of we finally, are priorities plan diagnosed by update will work And following XXXX. encouraged pegtibatinase and year path activities top Group to this remain planned we readout our provide bring that to with to by patients engage identify those a As FSGS. for in to line expand later discussions. FILSPARI with we and the an We continues in regulators able endpoints enrollment FSGS PARASOL growth, hopeful a additional be

start As we the XXXX the of execution outlined Travere. for at year, year of is a

As teams to year, execute am the Jula the and now half proud I Jula? have we over our while of call continued needs update on our patients they move front of how exquisitely all an the activities. second priorities, development of turn for of into mind. I'll the keeping across to our

Jula Inrig

the focused made education Thank achieving of you, we to FILSPARI and both that very during progress continue medical pleased as of to with RAS I perspective, IgA a FILSPARI care foundational approval to inhibitors priorities enable quarter. the have we on on am replace the and be Eric. From support for nephropathy. full providing these

And will which kidney nephropathy. overactivated believe its will We the addressing for the pill standard that the use directly kidney in long blocks nephropathy held of in superior treatment the the IgA kidney have a the IgA in replace profile address and designed immune therapy providing is being be system. and been ultimately in RAS future to the FILSPARI we which harmful for with nephro decades. to unique have lead long-term angiotensin, single are FILSPARI, belief of and overactivation the endothelin both the combination in protection, and kidney clinical injury and the damage overactivation addressing pathways, the in kidney that that the inhibitors, X

nephrology brighter in a including this referencing and their nephropathy. We disease caregiver and and shift of hope IgA a hear excitement We of FILSPARI about they of better personal evolution this the first-line for is and FILSPARI year nephropathy. heart how conference seen using outlook our FILSPARI data. this more FILSPARI and substantial patients who momentum as therapy. At community speaking an and on future. are care seeing now foundational stories control with nephrologists nephropathy with with initiating a in for attended growing We recently their the treatment a patient inspiration through nephrologists as We've the within signs heard practice, patients patients tangible feel among from IgA are IgA have and

an study with with arm in the and treatment one or additional in treatment, proteinuria therapy need in for of XX%, early other from their upgrade from We with of progression. which additional algorithms III This results replace therapy inhibitor patients inhibitors significantly is treated with an the inhibitors. demonstrated SGLTX IgAN, showing can we're we've diagnosing safely steroid. getting in an RAS placebo at Phase inhibitor in future stabilization and the FILSPARI And RAS SGLTX of IgAN FILSPARI. believe FILSPARI combination the that active that strong patients completed for require reductions generate addressing who a be continue and results arm those used goal incredibly that studies. immune and remain for eGFR, rigorous superior them effective to about the overactivation And aligned combining to they're patients data kidney comparator outperformed This FILSPARI, with remission can of complete will recommendations FILSPARI system. in of continued achieve guidelines to physicians that treating call the with will and both This if in them FILSPARI the risk over most the is seeing increasing treatment have simultaneous why their patients to into We for earlier disease.

is that kidney perspective, We will of moving a expect to regulatory algorithm. From the in therapy process expectations. sNDA foundational according part targeted collaborative the has FILSPARI be our and been

an in a and early PDUFA only and showed kidney interactions month. nephroprotective PROTECT pleased of approval, their more look function further of Pending for be broader proteinuria, with further progress to towards our a Upon FILSPARI next as reinforce prescribe grounded these we the anticipate reductions FILSPARI. of our we are the forward robust date and effects Phase FILSPARI PROTECT and as label This durable FILSPARI, in in full We slowest in eGFR seen significant providing the that foundational will eGFR seen to study. we study and to data including for continue the X-year approval, accrual full data believe well preservation, to decline achieving care. context would III patients benefits, would conviction safety data nephrologists our

let with our briefly Now, discuss me FSGS. efforts

improvements a to III with a trial, are important data favorable And timeframe PARASOL reasonable was difference FSGS demonstrated DUPLEX on to FDA, composite Phase needs size regulatory statistically living endpoint kidney proteinuria modified NephCure, so significant is our defining created the FSGS. and trial and effect background, another this this, irbesartan. the treatment eGFR order validated. failure benefit be meaningful sparsentan the than a a define proposed be while variability, in slope, per EMA, achievable. compared kidney an compiling and chronic a partial in pathway Phase III better and reminder, not data mils academia clinically right goal with With analyzing X.X a considerable called in endpoints such a sample for there eGFR the year remission These endpoint medicines to demonstrated shown and and As of was proteinuria because minute as can't per bring what within the we statistically to in to on initiative endpoint people on eGFR to endpoint sets should accomplish PARASOL be In function approval. the FSGS

is FSGS. We discuss this path we to that available work We our the an and optimistic for to program this we FILSPARI on FDA HCU. the provide identify results group plan let with me for for to engage later on our can and pegtibatinase taking program be are PARASOL are year. Briefly, once approval with patients and a grateful the expect update continue to

classical our We the to modifying as for therapy are excited about first deliver pegtabatinase potential disease HCU.

In consistently team around track their Phase Our to on and scale-up program. XXXX. hope to manufacturing heard we line from the support in top full pegtibatinase parallel, the HCU patient continue our launch. III and and commercial on and remain We enrollment enable targets program data attended work summit encouragement with recently an to patients caregivers

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

Peter Heerma

that half made the good strong Thanks, across the In been of I'm delivering everyone. Jula, very this afternoon, the have execution board. we year, first FILSPARI our proud of have teams on and launch, progress on focused and

In see XXX quarter, and new patient we and start We continue growth generated achieved their to PSFs. again strong from physicians patients. forms second demand quarter-over-quarter or the

and We FILSPARI's in continuing REMS quarter PDUFA nephrology key of build of drivers quarter, our momentum nephrologists we this continued in towards by accelerate months. a benchmarks we PSFs by of and September for second exceeding We PSFs after growth we our end X,XXX growth. Notably, number every of prescribers were continued new have of the nephrologists. which are the of certified well as XX further approximately approval, to total for demonstrated deepening recent one the rare believe now we saw that, will trials, of date each prescribers were By believe the that with base, by broadening clinical since further both generated we launch we in are and growth head early patients the as beginning is hear as tolerated reduction are new and prescriber the full experiencing FILSPARI from well are proteinuria to a safety continuing the rapid profile. their what sustained prescriptions

of the criteria U.S. payer experience are are rates and pleased the with we As we with having the access authorization more are are their reflecting for that they using and XX% having strong peers. Product lives very reimbursement, we advocates FILSPARI, nephrologists this is formularies. for a their and with claims with FILSPARI approval adopt FILSPARI strong seeing, they and also pathway pleased FILSPARI become plans patients, reimbursement to positive then

number prescriber base our increasing also process, a supporting patients and efficiencies initiating with of additional pull-through therapy FILSPARI. experience in are driving which We growing having our the positive is

inflection have All of the really second of as net second revenue the it catalysts revenue of quarter. launch, ahead with of in strong recent resulted outperform in benchmarks over pleased the XX% in rare I in year $XX.X of first FILSPARI quarter, am sales especially efforts positions this million increase us an to with us. these nephrology

ahead, look important PDUFA most upcoming the is catalyst date our next we As month.

from with mentioned, an to data patients. exciting based able to the expect initiatives would over full on approval time potential earlier patients further XX,XXX data updated from to trial Jula this, XX,XXX label, to we Alongside rigorous FILSPARI IgAN up we potential a physicians pivotal we finally conducted are have nephrologist We the educate our treatment be X demand and statement most that IgAN label, FILSPARI addressable X-year factors. evolution approval towards will in nephropathy for to further acceleration the on so foundational coupled date. of population increase believe As a broadening support the will patients allow driven the in the data approximately full has a which wider results our preparing with patient and Thus for indication use of daily been far, IgA our granted, to the from with interim by uptake confirmatory we to will of X-year believe if of largely practice. XX,XXX expect a analysis,

prepared, amplify the on leverage to FILSPARI. full underway position ready, are elevate zone our fully with patients battle to and engage are physicians to to Preparations We teams energized profile this anticipated approval. of FILSPARI and to

Additionally, targets. timing include the the that lining the this nephropathy solid will have teams that ambitious treat of profile treatment a be new anticipate part These population first in This and we in patients guidelines time IgA as FILSPARI proud to up We a and become proteinuria the patient they soon, second quite will to anticipate with paradigm, half treatment the the for would KDIGO potentially talented provide the that addressable year. diagnose they an more population. I will accomplishments of earlier first is couldn't available of emphasize broadening opportunity that urgency the to strengthening more progress framework the our half the that dedicated addressable the provide year. of and made patient broaden nicely. FILSPARI

serving patients forward more as moving We even patients. by for the IgA prospects nephropathy FILSPARI therapy the establishing foundation are driven of by

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

Chris Cline

you, good afternoon, Thank Peter, and everyone.

second operational reduced in significant to net period net a in for approximately sales product IgA grew strong quarter product we the to million for performance second and $XX.X of U.S. by quarter, to the XXXX launch attributable of led increase the from is product have and operating Net sales same use. cash sales During XX% ongoing in million nephropathy. compared increase growth to FILSPARI of continue This XXXX. $XX.X the

or per operations other to difference recognized of adjusted second share $X.X announced quarter or $X.X expense quarter compared million, net were XXXX. the On in $XX.X for as net in expenses the in other $XX.X million, completion. Total XXXX. Research the the of revenue, we Phase of discontinued were advance XXXX. net compared to share sparsentan $XX.X in and discontinued of $XX.X During per reported in from period, from to million of to million million second -- compared the On per for a reduced net the $XX.X in nonadjusted or loss, or million $X.X a expenses compared $XX.X basic loss XXXX. a basis, clinical the total which of share, million XXXX for period III results the collaboration for The second million income period was period XXXX, the from of for and to also for for same studies licensing million, non-GAAP including same million, second period period same quarter, charge $X.XX development was to to a a the $XX.X $X.XX million, revenue related collaboration quarter second R&D $XX.X enacted million XXXX $XX.X compared the million non-GAAP of and the the second other the income period year. Net net expenses expense quarter same was in were general the for in in XXXX to basic net On largely million, for a adjusted same earlier administrative $XX.X per is same for XXXX million $XX.X SG&A XXXX. XXXX. Selling, $XX.X including of period to compared basis, the in basis, expenses XXXX. noncash other million second Renalys the quarter decline quarter loss, same of to XXXX, $XX.X same restructuring in this the the loss $X.XX XXXX were to The $XX.X attributable basic at $X.XX expenses quarter of compared basic for million operations attributable share, operating towards to compared $X.X is the period for XXXX. end year-over-year total XXXX for expense the million

during included the of million the XX, second approximately use. marketable milestone XXXX, operating and Cash used $XX As cash quarter million $XXX.X cash payments June of cash, securities Company of previously and $XX million. equivalents approximately disclosed of

half in continued studies declined XXXX the over by further expected, is driven the the use expected as This complete. by million as well sparsentan and year and FILSPARI quarter, R&D investment declining contribution Thiola, from second in cash operating declines as in beyond. sales, of and Importantly, time throughout the $XX approximately growth are supporting

incoming from multiple FILSPARI anticipate payments milestone Europe access also We achievements. conversion Vifor CSL in of upon full approval and to market

to that, With shelf is into statement to the note, of closing SEC. the operations these housekeeping back set can comments. one a add administrative expire turn elements, believe alongside also Eric to sheet current shelf current measure we that registration as X. With support it our filing now XX-Q our with filing his on This new statement is today, a September for I'll registration we're balance our Eric? continue XXXX. I'll

Eric Dube

first delivered FILSPARI, collaborative Thank engagements in progress and my know made We that pegtibatinase have It's this half both at in you, Travere Chris. of meaningful have that with FILSPARI Through we've payers, waiting year. XXXX, they passion the reason are to meaningful growth us. and regulators patients. continued colleagues and I bringing this executed for and focus and with for the

achieve should We remainder to are progress to in year, years which position the Travere meaningful growth come. well-positioned the in and now of for further

Now, over let turn to for call the Nivi? Q&A. me Nivi

Nivi Nehra

the Thank you, line Eric. We up can for Q&A. now open Rachel?

Operator

from [Operator of line question will Tyler Cowen. take Instructions] the We Buren Van first the TD from

Tyler Van Buren

the on quarter. Congratulations

guys FDA potential a potential think approval outcomes? remind full of month, the removal a what we upon just us or about you modification suggested and the you as scenarios Regarding next REMS can the to

Eric Dube

And for for something this that approval, an monitoring no is are full the with is is approval. at committed what early additional our the that -- stands. What changed of And for step reviewing Tyler, proud forward guided And share being If thank to continuation independent know, to would to looking is, this we're process we back the multiple where think agency. that question. requires we precedent be as a with said, the us there you really within for modification, this first, demonstrate the first and ready I'd the approval. for a early a full REMS. update potential you data is, say, there scenarios that it ability take process, I'd are divisions certainly, this best those say engaging with foot with opportunity I'm review for believe engage precedent natural liver and with Well, previously both But the us to certainly that me in of again, FDA growth and regard during removal. including and we're we multiple this anything. to putting I scenarios, for the we've or provide that, we at much not of there with strong sNDA performance FILSPARI in with as our let

the where this of treatment land with FILSPARI of we growth the that regardless moving can is the So given now we IgAN. forward therapy for expect foundational process significant becoming near-term, in

Operator

from take the of question We'll line next JPMorgan. the Anupam Rama with

Anupam Rama

And Just you forms to, of kind a changed time? new say, think much what versus When prescribers? how that quick prescribers of attribute can start you're patient seeing, for and one you me. has over that repeat about how

Eric Dube

Anupam, one Thanks, over Peter, the for you. turn question. to Great. I'll that

Peter Heerma

deepening. see of -- prescriber broadening both both we as well Yes, from growth, nice think as the continuation the the a of overall, I base,

you like start existing prescribers, as where expect. that's I it's comes say, would as patient forms well from at exactly new you I prescribers. look it increase if almost in equal what on the would think

very successful line in think I much seen practices in the for and best nice very with the I launches. past So a trajectory, think I've

Operator

Leerink Schwartz next the take from of Joseph question will the line We Partners. with

Joseph Schwartz

on sales there's reasonable. Congrats received that like for our of on is X,XXX on company given estimate quarter just quarter. Based end a over I has And quarter. price, and estimate patients by X,XXX strong And over end to the about the the was over the the for the the you're does as a since talk wondering, seems converting it the should having that PSFs conversions we long cadence how PSFs scripts? success of of how -- could How about of the think bit of much quarter, or take? balance that year? you therapy

Eric Dube

much so the over Peter, thanks to this And question. Joe, one for also you. turn I'll

Peter Heerma

Thank Yes. Joe. you,

in as say summer we the What to good of I support a required I certification of progress net patient that the pleased we last we REMS fulfillment X inflection in efficiencies is process. earlier and benchmarks, are say, as are you're additional the process. for patients within the reflection pocket with better this quarter the in allow education, And process. and made think on in context, it's rare that within measures of see, that second is I implemented REMS growth well we're well of in both are would the mentioned And we But first, paid strong on the to our a making. question. like particular continuing certification shipments. making disease cumulative at that the patients in engagement And amount observed the number the speaking a we we time start the call, I'm serving, patients forms. fill as revenue really would

Eric Dube

how executing. Joe, efficiencies Peter's And, with reiterate pleased Peter. team and I'm have that been how been going I'll just those has really Thanks,

fundamentals be into hope QX approval, full exactly those are that where really the to through of seeing and and think conversion we're are I into happening. where QX we efficiencies operational in seeing pull going I'd

Joseph Schwartz

then this I and pegtibatinase, And has enrollment on point? been question a going Great. helpful. That's site how very could, until activation if up

Eric Dube

Jula, take you don't that why one?

Jula Inrig

in the dosed as really the pleased abroad. the and year. interest both earlier from is and first patient we're So community, this I U.S. this a call, And the to mentioned in on strong have patients we have

way, to we're goal launch. data quality line for and we planning previously study for provide commercial top and metering numbers in ensure XXXX. I've CMC up specific along not the our going patient We've before mentioned the scale have can for the past, we're said in As to but and enrollment we're strong full

Operator

will Barclays. We Carter the from of [Operator next with question the take Gould line Instructions]

Carter L. Gould

the Maybe like to being kind tackle from of angle. expectation to and then announced, of language that from guidelines little your updated? the the Upon announcement a a payer bit guidelines policy sort that of being different timeframe what's

Eric Dube

the hand that to Peter, for thanks over question. I'll Carter, you. one

Peter Heerma

Yes, thanks, Carter.

guidelines strong all, of script you be we I really positioned reduction, Lowering of KDIGO additionally, given soon. you're And part think also the data, our target remission [indiscernible] the the as our FILSPARI efficacy and expecting that would absolute as First I complete population. well, to well could allow proteinuria proteinuria broaden data. XX% are referring this better. patient timing to lower treatment that And will say the

So value our FILSPARI are we fast to regards when are how but proposition not the payers payers Well, in with only profile. go with payer on your are also excited their this to ready to part the plans? to plans guidelines. the adopt updated And referring their for payers momentum second are about really the we in question, of this generates will that FILSPARI. With label

time. really those the I'm that are So excited nicely quite coinciding in

a for managers authorization criteria it our great quickly. that with and to think conversation the update account ] to I very clinical payers provides opportunity have [ national

Operator

will the Jason with Bank We America. next take from the of line Zemansky of question

Pavan Patel

the Patel Zemansky. Jason This Congrats quarter. for is on on Pavan

likely uptake? And biggest hurdles far terms the gradual With then think could FILSPARI, driving what getting community with in about terms And as you an or update, ]? critical the bullish do of data more label academic you trajectory -- seeing impactful for in settings? the update, the you please the sort that could label you the to potential expect uptake in [ been the or from label be the broader feedback early What's of hand, inflection patient PROTECT conjunction think factors without prescribers? in thus of you've the to in be immediate and highlight been sales then, do most

Eric Dube

those? right. take why don't Peter, All And you

Peter Heerma

able Yes, about PROTECT the are we label, resonating first what data. preservation If like, those. commercially we question really, is is full talk like, not the most? that to full kidney eGFR disclosure, don't have and I'm take the given happy to And long-term are

the So you proteinuria [indiscernible] after the science is of really had they're X-year result in conversation had -- continuation about reduction. look field. excited look if that's quite the in then you the waning, data personal that irbesartan, And the that medical I've gives proteinuria that In hold continued if up nicely. at And you continued physicians and with confidence the that to you saw preservation. active there was control X the about production, long-term see that thought FILSPARI arm, of years. X/X will leaders while effect I measured we that actually to kidney be conversation this proteinuria mean,

marker main is that you given impact damaging of the factors one proteinuria So in damage. a of

really continuously you If a are able there to kidney preservation. translation long-term is to reduce that,

can why field. [indiscernible] in I'm that's experience Jula So most excited the about. Maybe about talk

Jula Inrig

a change better reduction, magnitude didn't discuss the able starting when our commercial that doing academic been data where And nephropathy. are able treat the to and even to IgA long-term durability Well, continue of teams clubs we're hear with released kidney I Thanks, it. to engagement, function, journal things believe the understand Peter. they approval, this, have understanding But combined the to full also and in full back the really have and a gets the community like hear both people being leaders, have and a momentum the team safety. and from proteinuria patients full hand they of preservation being in should And spectrum, have with role to we PROTECT data across an and I as which first going year-over-year with call, incremental nephropathy. label, the we're as treatment mentioned be we that able with on to engage and for of IgA a patients this we foundational

Eric Dube

think the you the So, what question. Peter, next Yes, you going why for do parts the uptake? the of of label part don't of are the drive question on to next part take

Peter Heerma

the allow elements think will was was to going about data and the don't last really think the with call Yes, given uptake the data, general, week. the spoke physicians, we can that I go onetime excited a really kidney long-term I FILSPARI step. and like relatively really have The that safety are was mean, and question it profile, expect? launch get are Yes, that all strengthening audience. full that, it's general. fast and strengthening for I But about about, But Jula things we the I a said think the how benefit an I there, having -- the nephrologists say at In now preservation like, do the label, I proteinuria you of we quickly in update that communicate we of long-term as wouldn't impact. talking the well. conservative

it's that think anticipate a we of growth forward. I moving continuation

Operator

will the line with We Citi. Yigal Nochomovitz the question take next of from

Unknown Analyst

Yigal. [ Reena is for This ] on

Just to what failure guidelines, fit? the or in on your are this? you will [indiscernible] used physician-payer Do being detail Do the on perspective option independent expectations where you see FILSPARI it combination? any inclusion have only wanted of as around additional an for frontline KDIGO after ask,

Eric Dube

All on perspective. right, Peter, one? can you payer anything add you that Jula, why don't And the take

Jula Inrig

diagnosis of of for treatment other KDIGO data approval that to and know the that published we've in PROTECT and of and be with nephropathy. guidelines recent occurs know, part U.S. publications, included we FILSPARI, foundational the we we anticipate And consistent kidney FILSPARI, Europe, guidelines. included have patients with leads injury given will we in and FILSPARI as care of the So, both are IgA

that know to The low kidney patients other at remain even proteinuria. started there's is, failure levels of evidence risk discuss Peter aspect that with we for that

lower guidelines push earlier of diagnosis the we to even for proteinuria. So and anticipate levels will treatment

and as treated treatment. as So components, as really the guidelines would patients expand a of the injury, the these levels FILSPARI X for treating can KDIGO the believe be we well of with diagnose foundation help lower the FILSPARI population proteinuria, and guidelines treat as who kidney foundational

Peter Heerma

Building today. you the on And about it's we that's point in the payer ]. that's that I see the think the immune to plans. And in large that, X kidney. Jula's how guidelines in as already to why make, [ protective more reflected mediation. acts being affected that that really category And like replacing I inhibition, FILSPARI, within well, think also natural point, medicine the really will is the and age And FILSPARI the particular then is KDIGO categories, really AMDs is inhibitors be the one, second like, case

of I think part your second the question. that was

Eric Dube

right. guidelines think the treatment have patients that how help what ARB that's the we mean, going step don't to remission. driving the already most sustain and we're complete we achieve seeing are know ACE remission, a or we back and take KDIGO now complete to think I we paradigm. steroids reach I in about Yes, One, opportunity if and for or on within

be the to but going so, is patients, to reach And therapy. ability require for it's going that, most to combination there

going while have proteinuria within guidelines, is FILSPARI we that that don't seeing we for expect space in of So reduction. profile kidney yet the combination. this because think is trend seeing, already that we're superior draft fully we're action increased core I that, the a to the underlying be have And KDIGO we and as the part the

are shape aggressive guidelines therapy the and remission more KDIGO to because many these is in going patients. reach fundamentally driving they within So help whatever of for now I think

Operator

the the Maury Raycroft will Jefferies. line with We of from question take next

Maurice Raycroft

I'll quarter. shift the gears and ask on about Congrats FSGS.

And For a establish have endpoints, the those FSGS to subgroup sense run analyses of would Group's entail? post-hoc outcomes endpoints satisfy study? FSGS new to potentially do DUPLEX in expect you PARASOL Or could a the you supplemental you or alternative patients? in of what have a work can do

Eric Dube

you for All thanks right, Maury, questions. Jula, take the these? don't why

Jula Inrig

Yes.

an do study, variability. is the There's PARASOL, their FSGS. mentioned while So on and as can't earlier call, for from the know too we DUPLEX eGFR PARASOL I not appropriate for much is continuing endpoint efforts, speak I

the effect different And saw DUPLEX, we the endpoint. within on at that modified a was other measure significant proteinuria, aspects. that reasonable remission endpoint is importantly, meaningful look statistically So you to how next partial

Now, and PARASOL was analyzed to what DUPLEX, suitable. And new we so far they've similar created is public what is commentary that, establish to we've saw heard from eGFR with not what endpoints.

they alternative at are and next what they've later an FSGS and and plan you FILSPARI a proteinuria to on for potential to looking path measures update to So and of endpoints date. that done and of endpoint? And well, then they're us the what to to out for they're patients more we'll give on is, exciting very year. come, that. track work moving on making forward place translates is they're good with progress at other aspects, read these is right ASN, this very the a based What More be that for FSGS, and a to

Operator

We will from question next Securities. Chico the take the Wedbush line of Laura with

Unknown Analyst

] Dylan Chico. Laura [ is This on for

be more guideline what be you for would is uptake? a setup So label? the of to it potentially impactful FILSPARI potential consider Would the XXXX, KDIGO prescribing it revisions? FILSPARI half the when Or updated second

Eric Dube

say able of us we're Yes, simultaneously to are and FILSPARI be that really not for those a could we position time patients therapy. guidelines I timing better. of as that able synergy the more lower It's expand for about Dylan, more question. to both thanks therapy drive have be To our a both. at great the label would we're KDIGO further target, a excited to that such because occurring potentially in reach to able the better be near to really of reach the patients, need where foundational could uptake

I parse really other paradigm. we out treatment to they're So, seeing We're that don't going in really that the each know as them influence either.

Operator

from with the the will line Thompson of take question Stifel. We next Alex

Alexander Thompson

PARASOL. just I to on follow want up again

And think this -- was from there helpful. I I really in itself on endpoint in Any was would a Someone conversation? in Travere you the proteinuria color meeting mentioned in the were of attendance. be you believe had towards that initial topic of past an moving the meeting, June. Can discussion you the attendance?

Eric Dube

take you All why that right. don't one? Jula,

Jula Inrig

for question. thanks the Yes,

increased is discussion, publicize industry in the FDA, that is But a and need alignment importantly, path work the around endpoint. the data groups potential there But analyze. ongoing the with which is the has we forward, partnership invited, work to say were plan a And remains analyses that put mentioned, been with encouraged later. confidence as would EMA, very gives we're that academics, I us by I was and the that say, we So, attendance. around what PARASOL appropriate a appropriate and earlier, also for of about forward readout, not only forward. full of these as to and data And across wait different FSGS, our to for a feel are for the unmet because FILSPARI about endpoints path the we I organizations yes, the to said treatment data, DUPLEX the need. but solid yes, full

Alexander Thompson

Great.

based focus I proteinuria, your that clarify, view today talking explicitly? your of to Or about guess, is just discussion on the DUPLEX? Just is

Jula Inrig

is based going been and on has work So discussion that this on, the is the public. that

the a either on PARASOL dialysis says avoiding which endpoint, you of and kidney look, based defining new preservation is of predicting GFR, function, If kidney function, long-term.

done other and let's the So based at and of fact that saying, eGFR the move difficult analysis top we increasingly they've of around is this is endpoint, which proteinuria a the look feel the eGFR, encouraged, on measurements, list. past

Eric Dube

the the patients were as many years, those complete better showing remission endpoint, for think our had, years, able the followed patients endpoint their is had Alex, our to achieve over looking Phase only remission from for study, where that really we've number analyses of like a by thing trajectory as well I subsequent Yes, at informed disease. II that perspective both partial is FSGS we the work in that an also done identifying DUET were

the this got been we're from I that mentioned, they hearing wait gestalt fall. think data as by it's the really, Jula report PARASOL point. till out So and this what of to But we've of later all at also informed doing we've

Operator

next the of with question William Tim [Operator Lugo Instructions] We will from line take Blair. the

John Boyle

on for Tim. This John is

you for So with looking of, of not requirements the some or the the the discuss when FDA to are give again. -- if current say, an the if the could be REMS timelines what looking to data I us for reengage with adjusted idea we be to PDUFA, amending FILSPARI REMS updates label could upcoming wondering was were you'll

Eric Dube

think can Sure. exposure DUPLEX, now used well on and from trials update the we our perspective Well, both commercially. what that as with completion as we've had along say that providing the additional such how is is our FDA we've REMS safety FILSPARI consistent with I way, shared as post-marketing the of

FDA. Of that course, all be shared of with will

continued that obviously, that label process, engage of sNDA way practice safety review feel approval the along a the we along and also in midst full first the bolster that. the to not potential of saw which on first to is the are believe opportunities was approval after REMS to The opportunity the there at of way. share updates multiple why in we and with But that And continue modification of we the that is a along we're opportunity way in to have we process, the FDA FDA discussing the that. package the

very soon. come to more So

Operator

We Fargo. Wells question the will take line from the Bansal with next of Mohit

Unknown Analyst

on for This Mohit. ] Fadi is [

do you limitation And class lot So, the I you use? agents? think think and IgAN for to far various view these fit into the coming on potential in be And right with expected as B combination doctors use to will a there would a with as the be future of inhibitors now costs think you agents do how be to a cell inhibitor approved wanted FILSPARI combination these market? a combination understand use? treatment complement drugs Do your of with also get soon, complement ERA and would paradigm new

Eric Dube

further certainly anything Jula, perspective. and from great. don't Okay, start Peter, why add you your

Jula Inrig

algorithm the treatment to has always been So highlight I want two-pronged. really

kidney block RAS SGLTXs, target then injury and also inhibitors activation. with immune and You the add to system may the maybe you immunosuppressants

approach, each safer two-pronged needed going role replace have development highlight, the on this in now kidney, standard But you're of buckets. and increasingly time, And combination kidney over I we're So to be FILSPARI likely to the the able targeting target the for that of that target the therapy those side RAS of superiority injury. to system. going has or is care shown only future. immune want inhibitors medicine approved is medicines to of to in right, be But superior

to going is goal. to we're going started need we data in but complement of X/X in still because no sparsentan. development into multiple be gotten this, complete to around medications when remission PROTECT got earlier that we're wait now get going and have complete increasingly not over of need for But that time. Now, very in remission. the steroids patients there's can in We're a it's one ultimately be to going replacement patients on And complete we're were mentioned Eric going patients when X/X to to combination likely to or there. remission, And all drug hearing after strong diagnosis patients we're with system which nephropathy. you to really therapies be going long-term going that target horizon, outcomes and immune for excited IgA inhibitors, whether BAFF it's cell overactivation, B using optimize clearly be early the combination. on they to you're

Eric Dube

anything... Peter,

Peter Heerma

FILSPARI as inhibition. With allowing the in reiterate for Yes. they perspective, in already let it space indication I take top are foundational care. the than broad and kidney, to and said, you this. inhibitor referring from me [ nephroprotective FILSPARI utilization, modalities different have at to regards perspective into a [ were of pricing that inhibition all, use complement category From BMS and really RAS always how to within taking studied payer new All replacing that FILSPARI has innovative ]. mean, will a is Jula of being a think that first about complement therapies? from an very combination large You really than different ]. priced It's that is on consideration a a position level broad priced mind

side now also I at across X,XXX over say to the very already formularies we update we have and in payer a strong Additionally, included want the like nation. are

strong formula positioning very a So in for FILSPARI.

quite I So about good strives category it's a for in different again, utilization. FILSPARI feel based it. broad and But

Operator

the Divan Securities. the with from question Guggenheim line We will of take next Vamil

Vamil Divan

Great.

the to FILSPARI. back start going one forms just So patient for

last this the increases like in is looks the more or start steady percentage of increase quarter quarters patient relative but increase side. forms, the the the significant sales of over sort even on much to in it actual few PSF you've had number So

people it Or get script? sort So just that the more sales better sort timing where there maybe were took a net PSFs earlier more sense started bills? PSFs getting there more getting visibility get written getting that's some would therapy? to curious, it's expect on of just just net forward. of just that. on driving of you're what of per to thing side conversion driving kind a So, that, helpful of going time what's a Is maybe maybe that be something where of bit to little pricing Is

Eric Dube

right. you why don't that? take Peter, All

Peter Heerma

Yes.

fulfillment at, all, I start that revenue. on of the First I pocket think starts continuation like, a transition growth, our forms that of the growth revenue ] also the made in uptake of much mean, cumulative sectors, we a question in it's a year caused have both it little we efficiencies of of continuation patient on today demand? in process. why really of slower like earlier relative that speaks paid both revenue the I to to a where going the think was continued have an that shipments. [ you're progress was to patients but reflection And percentage about are particular of do think in stronger growth I demand, part that And last you on the we see amount patients saw

see to get and early on. that's them faster and now that's allows reflection certifications we in paid reflection, our them pull on that made revenue the really shipments you that there, think see to have that efficiencies in We portfolio, And early much patients I the through modifications the REMS growth. the

Eric Dube

rate really under patients for what long that get we add, one their we so persistence their the are term FILSPARI the that's winning me we this that stories would FILSPARI. These -- Vamil, only think first basis with thanks. oftentimes me impressed finally, I finally, about they medication. weekly this the of But the Yes, is high on of very the for decades, I patients the The that a chronic and that compliance that's like support that outlook Peter, that so much drives And of FILSPARI. one time high control. diagnosis, gets have launch personal much good since and the hear for that, see. compliance a things thing think excited for thing rate use they're feel with about on That proteinuria I of is

Operator

the Ed of We with take next question from the H.C. Arce will line Wainwright.

Wing Yip

of Thomas couple for questions is asking Yip Ed. This a

FILSPARI? persistent us. So one the time fulfillment PSFs to discuss And Can what for average average to rates patients the of is you from convert on drug FILSPARI?

Eric Dube

Thanks, All Thomas. right.

So, you Peter, take why those questions? don't

Peter Heerma

fulfillment to in numbers. that get Yes, to to to expect which we at shipments, I XX I think XX launch With FILSPARI, the average, was time see experience, specific my you call referring the at you haven't year I days. are disclosed therapy time compliance persistency high and for the mentioned between disease rare regards what rates, chronic the like end, paid in and last the would in high

more initially efficient I think benchmark. the are were part We the higher within at we of now fulfillment. and well we are the at the end,

So growth making revenue I I to in progress fill. really answer, we reflected the are time earlier this think my And good the to quarter. that's think also in

Operator

Ladies you. hand and conference Thank gentlemen, this to question-and-answer I'll the call session Nivi. concludes over today's the of back call.

Nivi Nehra

everyone, financial XXXX Great. a providing call. for us look to our results your quarter Have We forward day. our additional for on Thank you, joining progress. of second rest great updates

Operator

call. your you This Thank for participation. does today's conclude

You disconnect. may now

Travere Therapeutics (TVTX) 1 Aug 242024 Q2 Earnings call transcript