TVTX - Earnings call transcript Q3 2024 | Travere Therapeutics, Inc.

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Operator

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

Nivi Nehra

Thank you, Shelley. Good morning, and welcome to Travere Therapeutics third 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 to

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

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

Eric Dube

and everyone. Nivi, good Thank you, morning,

quarter, Our of with launch. the position the FILSPARI and advancing team full for another has in delivered exceptional commercial ongoing approval leadership our rare nephrology IgA nephropathy

draft more growth Peter, patient approval from XX% a shortly KDIGO the continued team's demand, new acceleration and execution in commercial last in following hear start our will you As guidelines. full net than recent sales quarter and in strength forms in over resulted

great towards and foundational care achieving we to this. FILSPARI are IgAN in for become is vision clear progress making Our

with full and we enable for use incredibly growing tangible educate data label significantly drive to ahead, approval and the also care with represents as way to an modify FILSPARI If growth their KDIGO draft ambitiously to patients As the nephrology which liver and submitted medicines. I'm in IgAN. sNDA it the use the share we further this with the treat guidelines drivers key FILSPARI you, as approved, pleased liver of data. body forward are reach we patient modification These year provides now a other ability paving as strong believe with schedule include monitoring there FILSPARI support nephrologists for on maintaining the earlier will to is recently regular which that more frequency step should improving it would in REMS. more priority. treatment patients align us foundational access community to for work the monitoring combination in while safety X of The updated providing lab the of another look with

FSGS hope the Moving community. the offer the of recent beyond IgAN, new PARASOL to group recommendations

As approved a medicines are development in few rare for and reminder, currently there progressive disease. this no kidney

these We we ever look see care the context with in thresholds to DUET of of controlled very around but this at across data on sparsentan we endpoint that FDA, X largest our group including and multiple PARASOL proteinuria FSGS. We FSGS. standard touch of superior Specifically, experts, when studies meeting with the compared from time pleased maximum and this to trial clinical where scheduled DUPLEX the data statistically completed a findings. in FDA reduction the were potential for in proteinuria will studies, of dose points. shortly, look based proteinuria have a forward now we reviewing from prospective Jula representatives a aligned

we we earnings discussions update a an preparation diligently year. If parallel, would our in to With to by establishing a potential sparsentan working the goal of for of QX able call. able sNDA next sNDA for FSGS an on submit, to anticipate an full submission an FSGS We we being path filing. in anticipate In indication. approval our are provide are

Lastly, to X temporary FILSPARI Vifor key and Germany partners of and Austria. European outside marketing recently as Vifor's markets, Switzerland. access Renalys look CSL in countries. in with Pharma. And has our U.S. the other leadership, approval expand continued to received We launched progress forward FILSPARI we're they in launch now continuing to Under CSL

Now turn the Jula. Jula? let me call to over

Jula Inrig

II. These perspective processes, treatment compelling with from is provide kidney I'm IgA in nephropathy. as amplify pathways Thank profile you, confidence targeted approval nephrologists pleased blocks This IgA as we hear and increasing about and Eric. nephropathy. foundational work the FILSPARI angiotensin of X full FILSPARI's together to confidence rooted for medical 's to in kidney endothelin-X pathologic a clinical patients FILSPARI inflammation following the which and X role only the medicine a injury

evidence as gathering endothelin that of scientific function dual attended IgA angiotensin worldwide nephrologists. antagonist, Kidney the and preserves significantly FILSPARI, nephropathy. We receptor proteinuria growing the Our reduces for with Diego, just Week in demonstrates only San largest kidney patients and ASN

the of early presented supporting of broad in potential for combination way some treatment, Week, risk population other the data data patients early IgA data progression, paving FILSPARI well use briefly a the highlight these we Kidney supporting in as new use During disease of of important use at datasets. nephropathy with medications. I'll FILSPARI of as

approximately inflammation Also, study which of as human patients stable examined FILSPARI that was seen proteinuria data SPARTAN, They're in injury support with highly from newly recognized throughout XX% anti-inflammatory given to of with This inflammatory nephropathy, FILSPARI demonstrates with study mechanistic initial mechanism naive patients has up biomarker as previously of with the disease SPARTAN a clinical an immunosuppressive. in on and the SPARTAN important data FILSPARI that biomarker targeted period. that predictive part promising been patients pathologic called IgAN at IgAN magnitude Urinary more RAS CDXXX. with to reduction And we reduces FILSPARI. for measurement is treatment impacts systemic These of non-immunosuppressive CDXXX kidney progression. The the presenting XX upcoming cause achieving our nephropathy. weeks. which is available nearly look IgA with seen XX%, only data only FILSPARI We was of important that models remission diagnosed also eGFR showed the the patients with of consistent preclinical reduced how IgA meetings. and are kidney First forward complete FILSPARI inhibitor through is processes

kidney also higher showed the presented This function and We patients from kidney per reduced than promising is data proteinuria Uniquely, and proteinuria grams diagnose with of patients FILSPARI especially outcomes above on of guidelines patient's less patients also treat can calling and with or per per encouraging grams X disease. reported data gram we suggests showed important versus FILSPARI irbesartan that to all day. preserved KDIGO X.X recent proteinuria. burden treatment physicians lower similarly that day with patient ranges ranges to draft a in even for X.X given improve of PROTECT gram with treatment

patients with growing real we safety options multiple immunosuppressants, using from SGLTX both inhibitors well IgA combination for with consistent the extension compelling IgAN, of presented label world our efficacy use and as from and treatment as approach in Lastly, nephropathy, data in with study. open

to subgroups high-risk that was submitted liver from The first no difficult data complete IgA sparsentan DUPLEX and patient FSGS no session to kidney support nephropathy function only drug confident with FSGS FILSPARI, in cases patients of profile a overall what testing have low we failure IgAN a aligned used injury. rates the frequency monitoring the to our clinical consistent rates consider treated patient elevations monthly as patients it now change monitoring of the to request. Quarterly will and sparsentan continue presented the aligns the liver composite our genetic in of request new compared genetic care. In our to also treat. patients an subgroup with given demonstrated their FDA from presentation modification quarterly. We and them of on efficacy clinical and We the of monitoring the a especially using nephrologists liver deliver is commercial liver given REMS remission safety who in promising induced able including typically historically FILSPARI foundational change for were our and of LFT and to was to with achieving believe the in sparsentan the exposure provide use, expect data and endpoint of in even increased the trials within reduction rapid proposed FSGS was which sustained to the the asymptomatic remain irbesartan. The a the nephrologist. of with in greater is ASN, exciting our most of for which sNDA resistant frequency have FSGS, low in in a at with to From to we to trials proteinuria demonstrate treatment. patients population, the we high-risk breaking data in with year late data the regular patients well a perspective, to have REMS is FILSPARI confidence regulatory undergo package genetic we for change Thus, this

have year. to with modification occur of in this potential half this priority We the requested of REMS for review the submission next first

now potential and public the recent for FSGS as Let from to early sNDA data well turn me to submission their for the discuss workshop FSGS. plans path a held for PARASOL thought encouraged forward sparsentan Group identify a The who our as PARASOL Initiative were common medicines the FSGS community. we and and community, be with regulators approved the patient together the to leaders, of input industry October a to by for came goal in

through are a wish birthday. During stories no options. In family year as from than stories represent program treatment for third encompassing These kidney a perseverance old's view, better X,XXX adults patients data hope and the future, the hospital and path was the an to align. a consensus of potential databases of at the to the forward approved walk PARASOL meeting as children reviewed with the disease of firsthand some members believe people key participants approval heard leave sister's from sparsentan the for such a his attend more with workshop, we how our FSGS, PARASOL a regulatory from and with FSGS. and findings workshop, living consummate XX comprehensive that from the reviewed compelling X are I'll from our success PARASOL reminder rare analyses data for work which new in over

regulatory nature feasible DUPLEX was date. the in remitting is and FSGS, for in eGFR FSGS approval. This data study randomized to remain evident variability to our in measurements largest a set, endpoint too of due there much run relapsing First, the to clearly

months of patients, and proteinuria of that both risk Second, XX are is over based definitions strongly a biologically plausible strongly in by reduction epidemiologic data. with FSGS supported thresholds reduction associated kidney on proteinuria in responder failure the in including

remission those per in year negligible rate and which in multiple sparsentan irbesartan with the time, our proteinuria consistently weeks, patients years. failure. In a saw XX% stronger remission Medicine more heart gram became published the gram demonstrated stringent. reduction we at New kidney rates open of patients while complete X modified to and the durable X of to complete response of and treatment extension DUET, this the irbesartan. Notably, and seen the grams XX roughly significantly were effect with reduced In effect sparsentan this a with XX% effects its even of per a at endpoint sparsentan, to of of was studies. loss sparsentan DUPLEX significant see X per of of sparsentan, versus remission patients DUET meaningful XX% Phase minute DUPLEX have Among irbesartan remission. an grams treatment significant partial in got demonstrated years as was they study, the significantly pre-specified achieved achieved III versus per with approximately treatment mil meaningful clinically approximately sparsentan, across slower proteinuria both the had on statistically kidney Phase of thresholds double the show effects nearly kidney with remission, on effect statistically II kidney X.X function, statistically complete on down was DUPLEX, failure supplement, We more treatment and X.X achieve Journal modified as who proteinuria over label of of not And and portion rates endpoint that from of significant we failure. the treatment England risk thresholds powered outcomes, And partial magnitude follow-up versus

mechanistic therapy possibility ASN reduce is function. a proteinuria works With Third, be to how potential kidney the podocyte biologic pathway clear in to indicator a in to used forward. cell from DUET there of initiative injury, our is glomerular, presented were conclusions and And FDA an as which repair, the hemodynamics, preserve received as and/or with function. Most needs now to well through reduced kidney surrogate leading featured proteinuria preclinical to proteinuria in it at from for approval data a expected some in PARASOL were and of proteinuria endpoint of functions, data, data Insight, that kidney align the enthusiasm Journal podocyte PARASOL and number, in the from FSGS. again very findings, FSGS the sparsentan key Investigation importantly, was validated these improvements our in and Overall, and going in for stakeholder preserved with in we tissue community. recently was Week Kidney support and be group. believe DUPLEX resulting the full led Clinical failure These

for FSGS the the understand context will our the data Our FDA a now path an in and forward be of to discuss work with indication. perspective step next PARASOL to their potential

scheduled a to with recent parallel, and that with a briefing PARASOL for to so potential FDA we treatment. only preparing the we that that sNDA, discuss potential book modifying quickly development As the the following for disease are meeting In on Eric better the sparsentan who remains and be move interaction. I'll sNDA will robust will for now our touch it have HCU community we align a preparing program briefly the filing be an work mentioned, as the FSGS. position pegtibatinase to we're now FDA has the deserves in

in have Phase While scale team's Enrollment to the as to in continue in recently due Voluntary possible. we HARMONY restart the as a Pause process program utmost ability commercial and quickly of our Study improvements, we announced confidence enrollment the to up necessary III

to the in upcoming to on IgA and our made path look our grateful we've of engagement And with continued are partners. supply forward progress foundational patients regulatory to with nephropathy. for HCU potential sparsentan support We and the community to Overall, we the incredible its positioning FSGS. deliver FILSPARI

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

Peter Heerma

you, and Thank Jula, good morning, everyone.

new couldn't our an of we is field draft IgA build KDIGO to entire we the to the continued in very the strong to as typical the And that on and also the execution nephropathy During full focused train full teams. From start demand after be the we with more launch encountered and trajectory dedicated approval preparing for third the week field seasonality success and added quarter. our and quarter them took more following during new inflection the as with XXX third while noteworthy perspective, strong by FILSPARI we particularly encouraged continued label summer guidelines. driven for upon our strong growth full I patients the approval some results of start force This forms a talented our with again forms pleased holidays, I'm our than given is in during on weeks well as September upward out fact patient approval. that Xth. And new

will and which outlook. that anticipated would physician coming approval, new of As of And prior confidence patients to more physicians provides their the first as clear evidence time. to we we this to seeing FILSPARI prescriptions write through are added we our prescribed highlighted demand increase for

on prior metrics these continue We all our also the outperform we in we patient compliance net than execution, million our quarter on in high in rates. on in $XX.X rare and track growth. are net to to and persistency while quarter-over-quarter process product demonstrated launch. first core of sales recent gross FILSPARI has This efficiencies more FILSPARI of nephrology fulfillment continuing in most full launches outperform maintaining revenue XX% to a the year representing third With the launch resulted benchmarks

of excited more the opportunity even are ahead us. about We

were us now irbesartan. potential indication FILSPARI's in the our can This approval long limited communication educational during maximally new function label relative call proteinuria. But to FILSPARI FILSPARI's we with benefit X this discuss active IgAN commercial because we reduction efforts for over physician accelerate proteinuria of trajectory outlined long-term the last our period initiatives. under patients year of nephropathy who use further and preservation course full we discussing month, label, broader growth how X supports important of term new FILSPARI to risk communication at kidney with the our IgA FILSPARI statement measurement supporting and dosed is in our adult and in sustained full into and only As use compelling in accelerated two, rapid One, reasons. approval superior now allowing leverage full And FILSPARI's can to approval is I of accrues any comparator the translates is progression. kidney year-over-year preservation of

physicians at benefit beyond guided was FILSPARI that gram gram As exciting approval eligible below data patients use patients expands gram. gram indication only the broader week generally accelerated that full statement above last per that the the a showing reminder, to and ASN patient X.X indication our approval With per population significantly X presented or FILSPARI. at the also in from

the and to inhibition. already further are over FILSPARI nephrologists a up the IgAN for every to patient remission that call These they kidney guidelines at these to community eager RAS is and from encouraged well only trial in momentum. community aggressively. More who representative treat published The with approval. treated diagnose leaders medicine broad we what by messages treatments. These titrated nephrologists physicians in specifically, KDIGO of upgrade ASN are and heard isn't being week. more targeted guidelines are I medicine month reach resonate mentioned urgency of superiority the very And and have key demand the expected earlier, and draft emphasize patients their are uptake as we build in who to We foundational and referenced to with draft earlier patients highlight full we be by shown can are opinion recently the last post first seeing

story looks patient share IgAN the excited let FILSPARI his is of Chris, a exemplifies to on handing complete remission every that so why and school shared to patients. His me results the national report taking our impact feeling He great. about call recently A+ because in that getting as FILSPARI IgAN one we to broadcasts he are forward on morning lab receiving that over an describes having is in he an Before card.

there convenient one the we RAS every is growth many how and reflect hear IgA not draft dosed more patient new focused is of the our types that hope. oral, With FILSPARI targeted KDIGO guidelines label, shown we patients, execution, of establishing benefit only new stories our inhibition IgA regularly result may over this reach FILSPARI profile can in a treatment stories nephropathy our typical know teams motivate foundational maximally has and so and once that similar for option treatment While and and non-immunosuppressive as from and we are patients. living people these confident who daily are are the these with superiority results, to accelerating kidney ability the our provides nephropathy strong day. And trajectory

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

Chris Cline

and Peter, morning. good you, Thank

is of to same in $XX FILSPARI nephropathy. led will net believe XXXX to the IgA third strong quarter significant performance period This investments growth. drive compared sales areas execution we a to approximately in sales of XX% in our disciplined U.S. in the XXXX. product third the and ongoing for the During $XX.X attributable launch of increase the million, increase in Net grew quarter product for to million

is in the of revenue also total in revenue for quarter we During million a same SG&A R&D compared development million Selling Research were recognized administrative expenses third of collaboration to to attributable third and reported period in year-over-year million period in XXXX. compared $XX.X as the XXXX non-GAAP basis, a expenses $XX.X in license million the the million to the quarter III for XXXX basis, the period XXXX enacted third $XX.X and in operating XXXX. the to for XXXX. and in same the the period were $XX.X in of reduced general expenses expenses towards for same at and $XX.X XXXX. On adjusted $XX.X were were $XX.X advance million $XX.X million for quarter, results compared expenses to third completion. quarter quarter to same for XXXX $X.X the The of for for in the period million which same On expenses $XX.X restructuring million the the Phase the XXXX clinical for sparsentan end million $XX.X compared adjusted period studies non-GAAP of million XXXX. decline compared

FSGS Importantly, in we evidence IgA to continue as to potentially IgA efforts in in commercial nephropathy. generation to continue as support invest in invest FILSPARI nephropathy well and

quarter was Now period difference third million $X.X guidelines quarter with third to the acid full in million for operations per $X.XX XXXX. The same Net per income other same a share loss to basis, the third difference the gain in is to XXXX. $X.XX from $XX.X income. and interest recorded in operations in the or KDIGO share same share $XX.X of of to discontinued was $X.XX in $XXX.X XXXX Total is the per for income attributable compared attributable or of share hand. draft million non-GAAP compared which the for per quarter approval to million income period including bile in decrease the from of compared net the product net of a a loss basic of $XXX.X $X.X XXXX. The sale largely XXXX. including $X.XX third largely basic basic XXXX to related or or million period of On net in million the adjusted for from quarter net was was XXXX discontinued basic

expect including and cash September of decline time. the equivalents investments we As in securities our measured sales, our some pegtibatinase of XX, continued FILSPARI investments $XXX.X continue XXXX, growth to with beyond to and of over million, shifting used marketable XXXX, company, cash

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

previous new SEC. of with I'll our the This today, is continues also a to current Eric? operations into XXXX, registration not our to did in balance his a end shelf agreement the sheet position since new which in comments. our August. With XXXX. turn with as filing that, note. Alongside Eric one ATM of transfer over to XX-Q the closing to been which over we're filed that it ATM now All filing had I'll place measure support was administrative for housekeeping

Eric Dube

be launch and could I Chris. FILSPARI created performance of you, momentum strong our therapy of growth and foundational dynamics are the moving Thank prouder in forward a not have The our of positive organization. execution for IgAN. underlying as

As our hold opportunities community. rare and promise for in near-term growth for beyond XXXX great kidney the

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

Nivi Nehra

you, line Thank Eric. Operator, for we can now Q&A. the open up

Operator

Instructions] line question Joseph [Operator first Partners. Our Leerink is from with of Schwartz coming the

Will Soghikian

Congrats This great is here. Will on today. on for the Joe quarter

Peter So and force helpful. us it color sales seasonality one and between We would for Any taking just like metrics. have fourth up there other the trending additional dynamics in that numbers quarter? now are the the quarter. as appreciate? a dip in summer But on week chalked this be minor could seems second we to PSF for third And early here saw should out very here be things September. that in And how been mentioned,

Eric Dube

Thanks, Will. since let what approval. say incredibly particularly am full what I'll I we've to talk ask with and the impressed we've me seen seen that first Well, Peter? about dynamics, Peter

Peter Heerma

thanks, and Eric, Will Thanks, for question. the Yes.

and pleased nephrology accelerated teams for training continued of start during me we summer trajectory To for say and field benchmarks. really our we QX have we rare some what saw period typical the week outperformed approval to a recent how the I I'm we full point in the Let the that mentioned seasonality took for prepared growth approval. how in the out remarks, also in have

full XXX remark, about approval. and opportunity uptake how is prepared momentum will encouraging So I'm pleased the forums. based and really we in continuation the mostly us on accelerate in to of month start after I'm of are growth excited ahead us approval said end But really allows actually the the a the with full first year we patient strongly. what And over I seeing to the demand strong

Operator

with of Guggenheim line Securities. question the Divan Our is from next Vamil

Arseniy Shabashvili

much Vamil. data will reanalyzing and the thresholds the proteinuria's for way In specific with And on more for your feel versus of focus progress on Arseniy taking Congrats totality data FSGS, perhaps points? the visibility discussions focusing and you more PARASOL do and It's hitting our all FDA the that mechanistic the regard thank how you at rationale argument? recommendations to considering time and holistically the biological on certain questions.

Eric Dube

the question. for Bill, to much so you that I'll over turn you. Thank Great.

William Rote

you it's good for and one. question, Thank the I Yes. think a

hit the the you always agency approval can look be said the what's that as publicly will but on for surrogate data proteinuria based think of I in Certainly elements agency the full important. validated FSGS, in submission. has a full PARASOL, on used at the

that way and So totality to sparsentan you is noted, FSGS. cell targets. story, reduction the important proteinuria It's in in disease driven only parallel proteinuria I is in sparsentan your is make can healthier you case and as additionally, And is think to entire plausibility that. key due pathology with achieves reduce hitting a to proteinuria biologic the the the the of podocyte biology the and that of

support that. data, clinical have we that We have preclinical data

data know weight them, all-in-all, that So very but they space. mission confident will key on you I that this and strong have elements we're very we across don't hit how of X whole

Eric Dube

in thing in understand The That to them generated why that Yes. our we're be would to and is that data speak specifically here able I a take back, the said, we that to soon confident we only opportunity step you, we meet eager programs. what add very information they want. as have Thank we're that's Bill. with do the to Evan with

Operator

question with line next the Rama coming of Our JPMorgan. is from Anupam

Anupam Rama

of of package experience? Congrats of includes the data monitoring liver all but beyond me on all of you've FSGS the I'm if the a from progress that additional work, correct and data assuming clinical again, there? at IgAN ASN sort and I'm us in you the trial scope quarter. give provided on wrong the sense clinical the Can

Eric Dube

Anupam.

take you as that question don't why well? Bill, So,

William Rote

Yes. Thanks does. It question. for the

accurate. Your the DUPLEX from supposition for We is pulled the PROTECT. label trials, and open both data the extensions ongoing DUET, clinical

experience. commercial that as increasing as an data from that's of gaining body the well data the of we're So all

a we that all have data was substantial So pooled. and of body of

seen Importantly, of both saw the that well as see world, injury. failure low or elevation is liver extensions thing real LFT and of the the what the events trials experience, in in levels Law, the or commercial trial we've that liver we we as in no evidence Hy's same

that of much and quarterly that, the our we the to their a evidence a match to larger see built REMS having story basis which So frequency submission with cadence back nephrologists the body that on consistent that on change go hits patients basis. was

Operator

Buren Our Tyler next question with is TD Cowen. coming from the Van line of

Greg Wiesner

Wiesner Cowen. on for meeting and FDA? propose Type during will I'm get ask questions insight from to key of the C curious Tyler would you on the what the need are is to This you Greg TD what some

Eric Dube

Great. the Thanks back you. to Greg. much Bill, question, so for

William Rote

value think treatment of Well, been Yes. or suggested where have that in I agency for to down sparsentan below get they per day, a both PARASOL the they've and suggested you leverage to case, have with gram per need threshold proposal treatment make a arm, the us. But and come patients is gram spoken that a said most haven't at you the effect has so proteinuria about had have they discussions in irbesartan a endpoint. haven't X.X the they we talk of the that. the nailed control reduction What and presentation, that specific our their versus

it aligned to with for What and see data. really need what their here's submission sure filing to And that so do in everything the to agency reasonable is, will analyze they that's we're a need we our question propose when to the has spot So, here's the the go make you going our how in and about you think think we're else review. the in agency. picture proposal, they that

Operator

The is next from Jefferies. the Maurie coming with line Raycroft question of

Unknown Analyst

[ the is well. on Farzin ] Maurie. Congrats for This as on progress

Following pre-specified up going are enough is post you FSGS be sufficient? like on to also C Type good would data work label what considered then And or any the analysis, needed? data the do hoc be open meeting, extension? the you would on the include from like Like post any hoc already

Eric Dube

the much, so Farzin question. thanks Okay, for Bill?

William Rote

the both is be studies. answer label as Yes. the will DUET, label open yes. That as ongoing open Well data well short both from the from DUPLEX for included extension

that that analysis, the far analysis have around. gram, and and or looked looked points the in that of gram we remission, that proteinuria as to a per partial those agency at seemed addition brackets and ahead target X.X. we FPRE [ at plan post-hoc of threshold has the looked to part meeting. align pre-specified doing at ] So post-hoc modified cut X.X analysis of As were we the as around lot not X.X statistical We're

they data we have see review. and with that want and we with so will to have in aligned complete need to additional on we file them in what So that submission in that that get everything analyses their go the work the they

Unknown Analyst

which to you point you, Thank I'll presentation on And corporate Bill. our website. all Yes. our posted is

treatment very can for laid different and XX, at you superiority nicely Bill. thresholds, pre-specified a Slide look sparsentan clearly If irbesartan effect see and out you those FSGS. over the across benefit showing Thanks,

Operator

Scotiabank. coming The Greg next question Harrison is with from

Joseph Thomas

for the you Greg, to draft patients earlier opportunities update? on have patient treated This any might or help physician be getting quarter. on and can Joe efforts is ongoing the comment maybe and guideline education the recent just on on kind Thomas KDIGO you diagnosed of on one earlier front, Congrats based

Eric Dube

Peter? Joe. Thanks,

Peter Heerma

and think presentation has physicians, ASN, tells what with conversations levels. the I'm mentioned proteinuria I think the And back from I we higher Jula a like different had there. we benefit acts is populations. Yes, more helps to well have to there with that across patients that in think lower I action FILSPARI KDIGO is really thought prepared call consistently the coming think show I now hand physicians, And patient many data where the and earlier remarks leaders with earlier about treat from And also community also in hearing FILSPARI a to especially that aggressively. as as patients urgency

Operator

from Bank question Our coming with is America. next of Zemansky Jason

Unknown Analyst

too bit to Zemansky, like? FSGS. broader This you might might Ramadan quarter, taking speak on to ] FILSPARI's it progress Dina the little look question. opportunity is Could Though premature the [ what be on Jason this discuss Congrats and you a to for the thank for in of you entrant shift needing upside potential to market, new in given Is lack is, given likely shift? especially dynamics face approved likely challenges the or what this is the maybe something do quickly And are endpoints? a anticipate trial think of build to therapies, you our sort

Eric Dube

why are Jula, Dina, that that you'd on how don't I question. further to turn FSGS. you the over to anything add physicians then Peter, if Thanks, for Peter? and there's like thinking about

Peter Heerma

XX,XXX to Yes. for nephropathy. about the that anticipate XX,XXX patient a market patients IgA In making, as We Well, the group But we point be to may than we served directly for have Thanks, the smaller Dina. as the nephropathy. are in same really population about FSGS. addressable excited particular, the slightly this FILSPARI. U.S. you're IgA by basically prescriber is for is opportunity

point. rapid call expecting the the proteinuria physicians with approval, would since rapid they IgA the patients. the FILSPARI well brand already am clinical full we as is profile. And seen have experience well many in benefit name that and uptake get I So sustained established their like of if it's and as FILSPARI a we basically have will And nephropathy a the same of the have in so

think really And real can I as we it. that and upon. have we opportunity the said, build are a we about So excited strong position I is

Jula Inrig

high let with that very And almost patients. treated with population genetic effective one swollen for that get add well, they have safe They doesn't patient FSGS and a immunosuppressants really them. disease, day, if disease up wake need. they have remember, these be me work for unmet symptomatic really there's is They and a that is might nothing and just

unmet there well. for a proteinuria their high is can need help as non-immunosuppressive that So reduce particularly symptomatology their and therapy

physicians Peter's IgAN FSGS. it's treating who to and same the point, are So

address we with can do need significant a there that So FILSPARI. that we believe unmet here is

Eric Dube

would for we but And you brand Dina, and additional Julie certainly the recognize that thanks a so have much and there's as, awareness. as certainly question. there's recognition Peter, high outreach education heard and from

standard within expect approved leader to the if the certainly be care new of FSGS. and and first We

to So this a us tremendous there, opportunity community. but more serve for certainly come to

Operator

is with question Chico from next Laura coming Our Wedbush Securities.

Laura Chico

I PARASOL meeting making response whether if update observational data in consider had month to out one on thoughts ASN an treatment like earlier you PARASOL FSGS. There was the some FSGS to coming presented. this on and of I'm that would KDIGO commentary groups the have guidelines just wondering now, any at

Eric Dube

that Thanks, turn Laura. I'll Jula, over one you. to

Jula Inrig

typically or to change for They get would FSGS, be treatment Well, update anticipate I it's appropriate to thresholds for want do recently those then that there's full in we would but an target them certainly update. if where there's for. the update we sparsentan to potential. approval make time guidelines, an if an new and There just was

Operator

Our Yigal question next with Nochomovitz is coming Citi. from

Unknown Analyst

compliance comment the to This taking to frequency just is question. of on REMS compliance [ ask and rate might for expect this the my any monitoring? metrics monitoring, if how you for ] could Reena in I regard with or for Yigal. Thanks reduction adherence on wanted monthly the change FILSPARI liver for to you with

Eric Dube

Reena. you, Thank I'll that Peter, over you. turn to

Peter Heerma

for them. experience not targets. the this seen you're patient for What every as time that the they is targets. are product well as yet very see This I reaching FILSPARI, high. to they the works And thanks that that persistency population compliance seeing little are for Yes, hear patients that question. has rates think patients, of speaks a first Many are FILSPARI historically with their the physicians, actually that we the And time really they the innovation. of to is

the And really compliance full also of the remission, and some And those encouraging for that's I the patients patients. rates. is which are persistency think high explanation in for

Eric Dube

a and to that clinicians. monitoring their frequent would values with Yes. of patients lab and less these is support we as education We'd not have also patients support us have, including there level very We right from be the that the if would around and certainly part that these ensure REMS. just the modification the that still thoughtful the of but engagement from expect

Operator

is Our Wells question next Fargo. from Bansal with Mohit coming

Sadia Rahman

This for Mohit. is Sadia on Rahman

a on the that levels. IgAN you're lower to question reimburse that launch, below the KDIGO gram. X if update So seeing start patients targeted proteinuria given recommending willing for payers Wondering are

that Given there patients enrolled from that, payers? that any trial were been your resistance there has above

Eric Dube

data And Thanks to on be go the radar also question, for Peter. turn frame. patients might over are about the how Peter, based to to at risk helpful I'll you. talk ahead. these that

Peter Heerma

start kidney proteinuria chance dialysis maybe Yes, the it's that or data like to XX at, like gram last -- gram by There reach XX% within per registry to Eric, a set, patients still they failure the even progress patients X.X according good is point, maybe to radar years. of to

are On also of recognizing invested disease nature in a with is team focusing education really specific this bit question adopting as account progressive this. on this have an our well your progress quickly payers I'm we So quite Payers as payers that regards pleased guidelines well how as with the active we like the are a to and payers. aspect. new we the have are for is on progressive label? Well, with making new disease.

authorization lower in year, patients But and the XXXX. proteinuria criteria the good updated to reality see is we're majority, of Some seeing are FILSPARI. early early with the but start levels in with we that being uptake that's already also being treated the are

Operator

Stifel. from coming Alex is question next with Thompson Our

Charles Ndiaye

progress the near see just you on end how for current ask expectations This changing Congrats quarter. all our Alex. those in in about IgAN this Charles from LOE for to is wanted I and the on guess Ndiaye future? your

Eric Dube

Sure. the Thanks, Charles question. for

planning we LOE full IgAN for into our was would with drug We assumption XXst. in XXXX. exclusivity pleased with term approval for an sparsentan So the have to take that orphan us additional very current September associated to is that were announce that

Sorry, September of XXXX.

we have layers XXXX. our very are So both current base protection. into to of pleased is those of But assumption

Operator

question Divan Securities. is Vamil from with next coming Guggenheim Our

Arseniy Shabashvili

nephrologists community to feel out when a to Vamil. IgAN other based your thought now? on you In the FILSPARI's message of leaders uptake words, getting could for that is feel launched? versus now launch, academic on first nephrologists In group do with regards your you It's versus comment broader you for Arseniy

Eric Dube

I'll thanks for Peter. the to turn over question, that Arseniy, you.

Peter Heerma

Let me the question. rephrase

the leaders, like, thought to you're physicians. I the question is with uptake what is academia, seeing think relatives community, the that

and I So good have think what ahead. is, it's -- we here to go

William Rote

how essentially changed versus on full you launched. And when the approval now that first

Peter Heerma

are you uptake to have give or can is for U.S. mean And nephrologists be get we the post what that sense planning But all out in full you XX,XXX to of approval. think And like weeks changed? I to how I it's also It's far. realize able net we a XX% has X,XXX reach a said universe I the get about the good early nephrologists broad are Yes, to broader to on been about population. how an now that to patients. so about reach we X days. to have FILSPARI X of of patient

community. and that that's encouraged the the majority we get in the patients from of with leaders academia we the I'm feedback that community. where the in the and what that, majority thought said profile in the comes from about of really positioned. are Having patterns residing strong see being And So prescription those is also FILSPARI FILSPARI particular

care well as recent outlining patient the physicians to immune the And really utility guidelines the well positioned really really with a as is think be broad feel a kidney hearing that KDIGO that that physician. have target that resonates FILSPARI population. foundational what the kidney you system broad with is I for to I'm targeting

hopefully question. answers your So that

Operator

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

Nivi Nehra

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

Operator

participation. your you This Thank concludes for call. today's

You now may disconnect.

Travere Therapeutics (TVTX) 31 Oct 242024 Q3 Earnings call transcript