TVTX - Earnings call transcript Q4 2024 | Travere Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Travere Therapeutics Fourth Quarter and Full Year 2024 Financial Results Conference Call. Today's call is being recorded.Â At this time, I would like to turn the conference call over to Victoria Prescott, Manager of Investor Relations. Please go ahead, Victoria.

Victoria Prescott

Thank you, Chloe. Good afternoon, and welcome to Travere Therapeutics Fourth Quarter and Full Year 2024 Financial Results and Corporate Update Call. joining. Today's be for by all you call led will Dr. Thank Executive our President Dube, Officer. and Eric Chief Eric will in be joined by Dr. the prepared remarks Inrig, Financial Officer; Officer, Jula Medical our Chief Commercial Chief Peter and Officer. Heerma, Chief our our Dr. harbor Bill within to join we for of will Act and not provisions us matters that everyone facts Vice the statements Rote, forward-looking would this the historical like that Securities call President regarding Senior Private I Research Litigation Development, XXXX. of of begin, safe remind Q&A.Â Before statements made are the during are Reform

filed me our They the Forward-looking as assumptions known statement any XX-Q obligation disclaimer statements addition, or section Please well are results, differ not with that, today to disclaims and guarantees company's SEC.Â In cause or our the any Factors may statements such the on update those and date unknown only of performance, and statement. release performance. implied uncertainties, from the achievements issued the earlier over in to views XX, involve as materially call see Travere risks, forward-looking are actual made, specifically let statements press information, reflect XX-K events, Forms turn Eric. Risk future XXXX. the and circumstances.Â With to February and represent now the as such that to expressed statements forward-looking of by

Eric Dube

remarkable to diseases. by year, Thank you, patients marked a metabolic kidney Victoria, relentless and rare and one completed everyone. good innovation, just with and afternoon, execution, We a commitment

the safety quarter, third inflection compared nearly for in meaningful patients in to grew approval. FILSPARI full a IgA our This net and data. full September, FILSPARI's testament milestone following a patients we sales of potential FDA label sound IgAN. the the major to quarter, FILSPARI's their expanding It XX% been progress of now including also is approval fourth ability in profile the of with kidney robust to also excited our for serve.Â In more X-year broader saw of efficacy, nephropathy with with Our the preservation commercial to execution KDIGO the exceptional making company we've long-term we demand physicians and progress speaks draft to and for beyond IgAN strong alongside function culminated FILSPARI a guidelines.Â I'm in by FILSPARI about prescribe supportive and a

As last interactions data our DUPLEX supported submission, Type by we the submit we we This and our with patients, first-ever recently forward from believe help with quarter. completed are to studies believe we the further potential to indication week, end a from and group compelling therapy plan even lead for highlighted DUET FSGS validated greater our this C that by FSGS around and to an FDA sNDA process. of to patients potential the to could opportunity by the submission the year-end.Â We FDA-approved PARASOL represents findings continue the FSGS look review for and that

we IgAN continue HCU generating for which In hope and further touch the on community. to in pipeline, in potential Also Jula disease-modifying can addition, FILSPARI's in shortly. will broad to to bring pegtibatinase remain committed positioning foundational use, to we support the it and believe the evidence the

with manufacturing XXXX, optimize clear scale-up our our We and pegtibatinase and strategic of am I are progress.Â Looking our focused. to priorities program, are continuing pleased our into ahead recent

in aim replacing demonstrated broader that clinical that now data, we unsurpassed be care. label has RAS that the to role the into as new We a non-immunosuppressive foundational believe profile kidney-targeted will the to III HARMONY enrollment solidify our as in leverage review FSGS, FILSPARI reopening for process, unique for on over a inhibitors with this enable study, will historical and utilized Phase maintain submitting and throughout IgAN the next our foundational a future, lastly, therapy achieve recent and in a launch With pegtibatinase, on IgAN CMC in the potential working the to traditional positioning focus further and track efforts played.Â We will our only year. full FILSPARI's sNDA to preparing standard momentum high-quality approval and superiority of also that year. we therapy FDA we have later with are And

Following the update. near execute now year, well these call of for end strategic financing over key clinical are our successful to priorities.Â Let turn the Jula? the on to me we Jula capitalized the

Jula Inrig

seeking based a by standard IgAN. also superior and FILSPARI chronically complete X is well this demonstrating by ASN that patients reinforce targets. like pathways historical directly to in get treatment guidelines FILSPARI's their Thank a show IgA reaching approval IgAN remission to patients patients supported targets feedback the function draft be diagnosis with FILSPARI's KDIGO sharing recommend confidence treatment of from The more urgency lower the patients. levels nearly patients physicians from updated IgAN long-term into larger The data less a head-to-head lower that gram. SPARTAN long-term profile proteinuria demonstrate efficacy the following FILSPARI, used to and option start foundational per grams remission irbesartan.Â Also, population. or in as in over safety that proteinuria remission comparison as complete from kidney full in greater and to particularly in These earlier a on function long-term, data remission that physician all proteinuria more is to eligible used we're I'd with can preservation with be kidney has of nephropathy. into with as broader it normal a than the per the physicians at loss continues are both can X.X for achieve kidney-targeted, some earlier, expressing you, used treatment role defined segment to we see close is following label studies IgA that non-immunosuppressive, therapy. as patient and non-immunosuppressive nephroprotective nephrologists, of and if aging.Â Additionally, fact Week that the driven causing kidney complete hearing with complete foundational a and as are of foundational can FILSPARI nephropathy, get speak use Eric. removal This care FILSPARI full evidence is that When Nephrologists in patients injury, efficacy medicine, the approval that new gram from presented of threshold can safely nephrologists gram Kidney X.X PROTECT

study It position supports line use clinical targets approximately with with FILSPARI in nephropathy. shown earlier of Our earlier FILSPARI a nearly supports in in data soluble evaluates education highlights education that evidence inflammatory patients IgA treating and XX% on well medical teams the FILSPARI's the the studies for of benefits IgA continuing proteinuria guidelines. patients updated and combination XX a draft anti-inflammatory early a used urinary treatment diagnosed available on use foundational are on in with as lower treatment Phase FILSPARI of with in properties. Data focuses the This study proteinuria broader nephropathy. with II newly reduction medicines.Â For SPARTAN XX% IgAN that foundational biomarker weeks example, to as from and as has other also over KDIGO the as reduction CDXXX

SPARTAN share to expand ongoing transplant expect with post-kidney data IgA this the study recurrent patients also We preparations to year. study this later underway that are include excited nephropathy. from I'm additional to

the IgA in data remain of directly generate We new chronic and or generating to risk rejection therapy addressing post-kidney also are additional looking area a organ plan with use non-immunosuppressive more of for recurrent FSGS. These patients to with of disease progression. prevent already safe a this sparsentan is effective treatment in and its clearly immunosuppressive study high transplant nephropathy kidney, the to initiate data high There injury to need. open-label option and a unmet on patients we're significant need in at forward

is continue that new FILSPARI, heterogeneous. disease.Â It to in become could note to important this FSGS.Â We that to highly believe Turning approved, is if standard progressive treatment a FSGS

the in One position proteinuria decreased are for use is data kidney This FSGS of distinct uniquely a development program FILSPARI have clear not robust patient diverse approved.Â Importantly, efficacy our data and could demonstrated from to including correlation and historically broad important risk responsive aligned group of has given particularly subtypes, advantages FSGS the FSGS in seen genetic with has consistent the who is applicability by we across FILSPARI findings patients disease failure. PARASOL treatment. if that between is affected in the reduction with population clinical and our

we very with week, are on front. the pleased last highlighted regulatory we progress the As

provides recent to our an with quarter of Our opportunity approved interaction the provided end XXXX. it to FILSPARI and on data therapy our we plan submission, with of clarity the first patients in we for FDA the sNDA of believe Eric our for the FSGS.Â As and mentioned, submit first around become potentially clinical the confident are strength

an kidney emphasis This with FSGS. physician Our on and of as of its are proteinuria also our the medical disease understand of preparing role failure. causal enable education a plausibility further initiatives outcomes marker heart teams in biologic such the to as important physicians the on impact will proteinuria

our to patients first for Turning it become disease-modifying with potential pegtibatinase only the we to continue in program.Â As mentioned the for to Eric believe briefly therapy earlier, and HCU.

next in pleased scale-up pivotal on study We update. the year.Â With optimization over progress that, will with to to the for call manufacturing restart HARMONY Peter expect I commercial turn are the now Peter? and enrollment the the for efforts

Peter Heerma

marked period the fourth Jula. since FILSPARI to strongest I'm pleased during our launch. commercial share Thank exceptional you, performance which for quarter, our

key the with the will prescribers.Â On of U.S. FILSPARI growth. have expanded This clear I'm representing the with repeat the evidence nephropathy ease proteinuria by further XXX with patient payer and expected, patients confident the authorization of we formularies. we rates, approximately our in fundamental we we in of nearly sales prescribers continued to have adoption FILSPARI's accelerated access look XX% launch. is will net for been successful forms, best have the more pleased previous our IgAN see elements of prior exemplified above start market, well levels. approval.Â In high gram we as IgA growth see progression access label, been among start gram which we particularly disease levels which and As expect come community. X.X criteria, driven demand to also impressed as high to XX% in has of broader per This compliance patients addition in lower we FILSPARI new both an accelerated quarter, a under the reflecting new the In quarter.Â To quarter, fourth in mostly in or be for ahead. excellent the $XX improvements This full will XXXX, and approval be has demand, fourth indicated product increase FILSPARI as the access, if drivers we coverage, the depth process or million fulfillment continue and strong are by persistence risk uptake we at from to received the growing updates in in and advancements These strength beneficial conversion resulted with front, achieving seen over quarter, as patient therapies for continue FILSPARI's future all of to proteinuria label increased a growth

the active therapies the level for continues patients has kidney-targeted complementary expect risk of foundational to all fully superiority means to to been kind nephropathy expect them landscape gram high Furthermore, uniquely and demonstrated For control to get nephropathy versus be will IgA accelerated per the X.X maximally which treatment them as FILSPARI for only may that be limited an gram modalities. of only progression.Â As will defined of the approval, that dosed is to of positioned This non-immunosuppressive above. other as the combined at FILSPARI patients indicated medicine the foreseeable more we and historical progression, it be be an at long-term has with FILSPARI has that nephropathy. label for generally future, with be standard and risk adult evolve we IgA care and option of only will proteinuria of medicine its approved a disease initial many have IgA and to flexibility

proteinuria historically population set and first increased patients the level in target has result replace positioning in IgA Consistent segment, become this earlier only only group is with the RAS ultimately approval over While FILSPARI FILSPARI nephropathy addressable played months X.X are as above us. this achieving Notably, remission.Â As have ambitious FILSPARI getting of gram estimates The more the patients diminish gram of to driver which active we driver, to draft over proteinuria from the is this suggest ADS Jula, a likely approximately complete we IgA complete and have therapies and superiority to following is maximally initiating starting grow levels nephropathy. X.X diagnosis between are treatment in with X.X per KDIGO time gram, growth that is role for kidney-targeted high-risk patients with of biopsies, good large behavior. as in will access gram segment the shown gram are and this of with to traditional thresholds and patients guidelines an in to remission.Â The with in believe ahead preferably gram guidelines medicines per heard expected IgA earlier nephropathy below and a a full option making gram more have with therapy encourages updated lower FILSPARI our earlier good highlight goal we XX% guidance that now of IgA KDIGO. have updated opportunity inhibitor, our signal this available.Â We about be that of addressable our the patients or headway physician of diagnosis, continuing few to targets expected control per X.X is treatment change also by X.X approved gram. treatment draft success for median continue also per treatment dosed to with and as the This XX% may you ARPS the

FILSPARI me the We experience.Â Now modification the the requirements, and on if the as of FSGS, adoption expect are for to potential payers opportunity touch guidelines physicians ease summer, patient monitoring if could of finalized.Â Finally, the continue approved. among in this liver further this process approved the to adoption enhance let and briefly drive

Depending on FILSPARI of XX% for As across high anticipate prescribers, With medicines need our FSGS. treating well that Based call lower the uptake is established most patients is levels. up for financial potential and that FILSPARI's of this addressable we manifested progressive position in and with over is target turn could The in with the strong confident Jula extremely our need and label we will IgA urgent nephropathy often are are a high elevated established unmet earlier, outlined the approved. disease approved overlap with to nephrologists the Chris see the over FADS approved.Â I'll Chris? now update. we in if of language nephropathy, IgA with estimate proteinuria, to strong FSGS for and urgent the on patients FSGS indication, to proteinuria community. U.S. for nephrology glomerular and we FSGS be if assessments, XX,XXX treatments

Chris Cline

In Thank fourth the and year, and quarter you, have the continued Peter, afternoon, new everyone. operations entering good our to strengthen.

sales we and As seen net you have FILSPARI of approval, remains a heard for product meaningful from Peter, outlook full in strong. launch the following inflection the

to growth.Â I'll year-over-year drive We we also generated fourth significant of $XX.X where and with we're measured sequential quarter, the representing in be to sales our in revenue, million product investments start growth. continue making the net

of during For which and nearly $XXX.X XXXX, for $XX.X Thiola for the the net decrease a launch.Â Thiola of the contributed dynamics. million and quarter full XXXX. net product product year product million to sales full outperformed product FILSPARI compared the for a net generating is fourth the fourth in net full $XX.X were result continues year $XX.X million the fourth for $XXX.X first benchmarks to XXXX. year, quarter year sales in be sales sales slight million, also the key The EC growth driver, XX% the in million increase quarter in Thiola's generic and full

segment $XX.X fourth revenue, year in our of further were approved quarter operating and several reported for there for of this total also $X.X throughout generics this year.Â During we license XXXX. Â Turning full in we do million revenue recognized quarter, which million the expenses. for $XXX.X XXXX, and smaller sales, headwinds results anticipate to the the collaboration of Given product million

on million the were the expenses administrative million of in quarter of R&D IgA meaningfully the expenses the a of $XX.X quarter $XX.X reduced the fourth SG&A On quarter period in commercial million compared the research as enacted by initiating basis, basis, Phase period million for FILSPARI and development expenses in in and same for compared Phase a XXXX million the for in period. or as our a well fourth XXXX. income were for full towards share for includes to XXXX. to for $XX.X $X.X including million million year the million operations work period XXXX a the discontinued loss XXXX.Â This or same bile $XX.X net per million basic was compared successful $X.XX year sale for was as for XX, other sale basic difference non-GAAP XXXX.Â As or $XXX in expenses or Our XXXX. in $X.XX period same financing $X.XX the to XXXX the including investment pegtibatinase was share in to quarter our equivalents, $XX.X per $X.XX net nephropathy $XXX.X $XX.X includes same basic and restructuring million were to largely completion. from following or of or share partially clinical XXXX. Â The of fourth FSGS and of same income general that discontinued the period XXXX, million XXXX for of in $X.X XXXX.Â Selling, loss, as completed $XXX basic December per November. support expenses $XX SG&A approximately share for for $X.XX was per million per $XX.X was full to quarter we R&D basis, full adjusted as net our $XX.X driven at The the operations reduced its including $XXX.X On was indication. Â Total by basic compared for same same to compared of million $X.XX proceeds gain the and business. Â On XXXX.Â Overall, period period same share early year were period in compared is million we same million XXXX $XX.X share the XXXX This compared per quarter fourth support marketable basic share $XX.X million non-GAAP for adjusted the to FILSPARI million.Â This in per adjusted million basic recorded from studies a the operations the non-GAAP or XXXX. to $XX.X per advanced for million fourth totaling period cash, acid $XXX.X well net fourth the in basic loss, the compared XXXX was program additional compared interest loss, XXXX end offset $X.XX discontinued cash Net launch expenses securities III XXXX. Â Net to in million $X.XX or the some attributable lower during share $XX.X the had $XXX.X The to in for for potential of III to was the million

and CMC continue a as launch to launch in successful outpace remain in expect to benchmark in prepare continue enrollment look will support in we we As to FSGS, believe in sales ahead, nephropathy XXXX, XXXX potential but for FILSPARI restart perspective, our investments launches. Â We nephropathy, a compared and to From expect we strengthen IgA we program. gross a will further grow net and our the revenue optimize further. significantly in net our to discounts business pivotal pegtibatinase our of increase to efforts IgA disciplined product also moderate we

to to our balance approval incoming and with market closing year. Â With Eric? advance key Europe will it our full time milestone over plan, cash our sheet decline support access anticipate we later of comments. aligned we use investments and be these conversion now to in this that operating able for Eric from CSL achieving milestones the growth.Â I'll upon turn his payments FILSPARI over to to continue this will priorities Additionally, that project Vifor

Eric Dube

and for you, in great are is Thank bar another In of execution closing, year XXXX members year we progress high, XXXX. all Chris. positioned great and was by our but a The team of partners.

will outlined all starting for deliver priorities we in call year.Â Now is the look the for me I outset these focused we as to the forward key near stakeholders team Victoria? over and keeping you at Q&A. and of Our the call.Â We believe long reach on milestones informed our our patients X throughout the turn value the to year of key will term. let And Victoria

Victoria Prescott

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

Operator

now from the JPMorgan. will Instructions]Â We from [Operator Rama take question first Malcolm

Malcolm Kuno

Kuno Anupam Malcolm on is for Rama. This

are With terms in what you uptake? of FILSPARI the label, seeing patient expanded

Eric Dube

I Thanks, Malcolm, the to one Peter. turn question. will for that over

Peter Heerma

Yes.

was the meaningful I think most makes in what we have a XX%. I that also proteinuria is prepared given that more But higher.Â And approval patient think of our patients see per risk with start full patients X.X that prescribed we see accelerated FILSPARI. you now important is the we aspect I at use patients in in also sense out are grams And approval, new that called progression, really level focused increase reflected saw that forms with we a lower levels. rapid remarks to longer in in no on proteinuria being a of the grams have the that start threshold. generally proteinuria like And or being

Eric Dube

the Thank Malcolm, seen add that thing full Peter. of in number increase those you, would for is that continued broader other we've label. particularly in approval were the prescribers, new a Yes. waiting that that I only

prior find it continue with confidence uptake new that calls, going Peter think I patients. us And we're they as has this to that great so gives in to discussed as see experience, clinical

Operator

Our Guggenheim. next from Vamil the from question of line Divan comes

Vamil Divan

Congrats progress. on the

quarters, several but impact label. difference more just So thoughts a safety that if how get evolving bit and there's sort just might maybe you remarks, on provide monitoring, you over dynamics competitive uptake, competitor the from if obviously, and the curious that between IgAN FILSPARI's here liver how this little entering the especially label space the of a one, just little you next just see in your you prepared new touched the I'm on a a can might Novartis.

Eric Dube

for We little our growth on to provide the question. the of bit for thanks hand more Peter it very a comments over and FILSPARI. assessment. I'll Vamil, confident outlook to profile remain in And the

Peter Heerma

there's believe was entered quarter X.Â Fabhalta you mentioned as that and a first competitor. the as be actually that Fabhalta till fall have last marketplace year for in Thanks Well, Novartis new QX we saw launched our that question. the well.Â Despite potential we date. the was that, strongest I Yes. to quarter

different competition So of there. But it haven't different also we category. action, sense a mode treatment a it's seen and makes much it's because

I you of alluding more grams the label want progression, as think in resulting the the in that particular proteinuria good endothelin. category more I approval talking what may a to on be to of proteinuria that. Â Let will mentioned higher. well couple importance on patients initial things would kidney in potential we be bad how of FILSPARI will is more endothelin with start translates inhibition kidney convenience.Â The sustained into progressive same an that That likely the that play after proteinuria entrant the resulted benefits. Â A I'm of able as reason can category. simultaneously say actor the XX% the me an about over period that about rapidly or in is would well be profile, to X-month X I angiotensin that. to and atrasentan will do in largely foundational focused segmented X.X regarding be improvement it's what to a PROTECT, in like in as as I treatment treatment it is as in And have of the saw is new impressive disease as full both blocking that year-over-year. FILSPARI reduction well benefit treatment, in When within company differentiated of of consistent with why talk saying long-term efficacy before, injury. that another strong FILSPARI preservation and in specifically the confident as not We They X-year months label look

are say where we IgA think strongly atrasentan in on I And that very may approved I feel I milligrams very be dosing be a the XXX once don't to all, think and would flexibility I positioned. also strong come will more profile. with all XXX this the in for we providing. Â So FILSPARI one offers they yes, have nephropathy. So

Eric Dube

last you, to out question Thank close regard And REMS. Yes. your Vamil, of to part Peter. on just the with

see said, have need what scenario. we reasons if when to we'll label think believe competitive the Peter we their of like. a for profile approved, all very regardless, be what that I But prepared that looks for that and and we any

Operator

line of the Laura from comes question Wedbush Chico Securities. from next Our

Unknown Analyst

for Dylan Laura Chico. is This on

the FILSPARI the FSGS revenue, setting? launch position overall realizing the in will IgAN of might to guidance you for So change be trajectory when provide a

Eric Dube

thanks Dylan, Yes, for question. the

data So the quarter, pleased one in do approval starting. quarter the been want very a make said, that that with and we see we've able uptake, have particularly more estimate to it's just With But QX. to we really since we're pleased to how full points first bit be is sure to that.

at but a certainly this and provide we'll along updates But in not position the point, guidance, So looking at that. it's looking are we're provide something that we way. at, further are consistently to

Operator

Our from question of next Raycroft comes line Jefferies. Maury the from

Unknown Analyst

BD noted on This wanted to the I is continued Maury. have Farzin side. pipeline. diversify BD ask to on the you for Like

looking potentially renal to launch? in-license Or space? rare should Like be be the you it we this will assets the in more So year? on will what FSGS expect focused

Eric Dube

development. we And you,Â Farzin. medicines the in that It's add potential a would the as Thank Yes. looking. are And are I teams time. this believe about renal space. the the really that say our with other could renaissance area certainly infrastructure within to and an we that value experience, certainly rare I've exciting that talked capabilities,

is FILSPARI able #X make on bring able to priority at, to So certainly, to sure something it's strategy. provide patients with be hard that timing, that always said, specifics we're but looking our to FSGS. aligned we are With with our to

have will don't parallel And bring top so looking launch while our remain that potential to to therapies our patients at for opportunities any. preparation diversify and priority the in

Operator

Tyler next the Buren question Our Van line comes from of TD Cowen. from

Unknown Analyst

This on Tyler. for is Greg

this the And happening? So there the FILSPARI for the assuming be removal steps ultimate for approved REMS a goal modification will date, full PDUFA remain is at the precedent what around of towards REMS? or

Eric Dube

Bill. Sure. the I'll that one for to turn Thanks Greg, question, over and

William Rote

years Thanks. Yes, perspective, monitoring our looking of that monthly that well learn I a end forward at major monthly two to past frequency and REMS. discussed of the in exposure, of the we not the we'll to discussion first post-marketing amount the upon request the noted, quarterly REMS to from said, in agency about first the change as is point, summer, this from patients our a wanted full future. to we're they X,XXX But in step, with changing to quarterly see data removal specified to have look but enough this from August certain the when over outcome and to as where entertain the the initiation. we're order our you around in step first year. way The had We're on modification

Unknown Analyst

another successful on quarter. Congrats

Operator

Schwartz Leerink Our the Joseph next comes question line from of from Partners.

Joseph Schwartz

Based looks it price, of received current I launch. might around the X,XXX patients end X,XXX the be has on the PSFs like on the of over beginning reported sales company and the there And at FILSPARI since the year. think

discontinuation rate. figures the these therapy us So is you context I envision what wondering by? the patients can if additional of help you us to conversion well Can on difference the provide between accounted as any was as on with PSFs

Eric Dube

over to Joe, the questions, that turn and one for thanks I'll Peter.

Peter Heerma

Thank for question. good It's that question. you, Joe, a

would I overall, fulfillment a now. right we have very strong think I say that

revenue growth as also start year, as ago our improvements see fulfillment.Â Last trajectory in we or And that well. quite commented in made in that had to the equals was in If the speaks like certification first have the REM FILSPARI we I in about XX nicely required what you a ago, year a early the able we the particular, patients patient pocket handholding look only weren't package insert. years we X.X to process, there in it form, on the label promote think X days, and launch, more basically little of our at in or

of seen have treatment efficacy that for patients FILSPARI, with with as well we approval make the have package especially package, to Now our now full option as data really where more in both them improvements are XX% the have of I have we you done have full patients strong an up you said research and conversation products, comfortable about that that all we process.Â Â Having to in safety on overcome even never rest fulfillment never and pick XX% the and The to that from up picking retail, about retail that, their in patient conversion also medicine. nephrology some start to you you get even realize medicine. the have that, mean forms. their XXX% have

So is a points. certain there leakage

we have where are progress leakage made that. we think have and on were, I points identified and good those

start patient continuation will So paid that forms performance. expect transition of will I stronger to you see of

Eric Dube

and Yes. another question very Joe, rates. Peter, high thing as that. compliance continue data add Thanks, discontinuation And only would I point we the see persistence to for just rates, around for your

they medicine So of not is a see once patients that this where you discontinue start. disproportionate number a

is patient part such talked therapy. pleased So about, is on, really, good experience, the including we focus, as on as talked there consistent we've label really the seen of saw from about. that teams Peter get with the patient is form a expand, as the the our patient been launch. We've Once very the having positive start Peter progress,

Operator

from comes the question line of Liisa next Bayko Our Evercore. from

Liisa Bayko

a on actually. have progress. the Congratulations all I of couple questions

all, year? give to it and can sense of us net this how gross a thinking you for First you're about of just

Eric Dube

Chris, you don't Sure. one? take why that

Chris Cline

Sure.

year to occurring be in be balance of highest higher. through to to remember, as previously have FILSPARI the the net a guided part in we the the gross out first SoÂ Liisa, it you we're quarter bit for This year, might the with teens to evening and to had high mid of for that then year. expecting last

I thinking the about a the where the early XXs. of it's greatest similar to through we be phenomenon expect And the best bit going probably impact low teens of to a is And high year. way even in little year the balance it be that more for think so and to

that helps. hopefully, So

Liisa Bayko

any -- in reason? the for prior how kind of that? to we renew first anything or is any And having beginning it that you year the like with are to the Should -- authorizations expect quarter in the patients going bumpiness do of required have

Eric Dube

you Peter, don't one? Yes. Great that question. why take

Peter Heerma

be we -- mean seen Yes, haven't really an you're right. issue. I that the to

what are how the very impact removing mentioned some haven't completely really payers but renewals with in say I on payer particular prepared of in pleased year, particular of and remarks, broader proteinuria adopting in would far. seen the levels, You FILSPARI, in already the edits. we I so label have the beginning of them an the that for I'm plans, step

So I haven't renewal criteria, seen we good question made really think really impact an progress. on to But we your there. specific

Liisa Bayko

full we ask just pick the the they go the can and on will of that do rollout compounds. forthcoming I'm step sort you'll about and of accepted something label best of other to specifically. know some widely curious you've you potential BAFF when Will the initial how that a in ideally, future, newer payers of and era, the combination want if is thinking you And we're then all But kind of of thinking are more APRIL feedback between one choose to Or new think that have wanted gotten to beyond FILSPARI you think physicians you're two Is even how drugs. branded on from use and there about some of to get criteria? that finally, Or going any point want about you'd some APRIL other? to be these these? to I because have medicines? to it or you about I be do and the use mechanisms? through be

that's payers. So a focused and kind concern the less more really on of of

Eric Dube

going look to ability that on market And combinations is we Yes. get to the from turn newer to IgAN said, one treatment. consistent as to this see to well that we've been that that of over feedback years It's be date in really Peter that this eager the as to have We're in been payers. is good that's what able we've immunosuppressants.Â With combinations. question, I'll seeing over to be at the comments we're future a And generated the largely predicting why data Lisa. very on

Peter Heerma

something And modalities, the excitement when a treatment across if different question. It really good categories. you well. nephrology different KDIGO is read in it's the as they're Thanks, that treatment Lisa. to And community Yes. particular, advertising that's I guidelines, be think there combine will definitely

in to what given the particular, In is that like payer and So payer, already, medicine. confident for FILSPARI payer we of about combination. am, point, formularies our the to broad it's Payers dosed that with that's also standard is population accepting your really was regard, gold talking access. very evaluate that regards the with inclusions about I really how to. have. Â On comparison FILSPARI patient we what to top broad exactly the maximally that, head-to-head generally is direct want priced I studies, payers of and applicable see have

accordingly. have We priced

FILSPARI. be we new what they So far. and it's will table this. point, evidence may up that, see how bring criteria entrants, with to I'm inclusion with very confident very and so pleased how for to the price to planning they combined been the to they our And have Eric's But payer

Operator

Our the line Citigroup. next from question from Yigal Nochomovitz comes of

Yigal Nochomovitz

Just a couple of things.

answer different or the if do conversation? shift on FSGS So label it expectation on is If could quarterly, that to a the that, that you to REMS, that's you the the the flow would please. get

Eric Dube

Yes, answer I can that.

when if have that assume and REMS we So the same labeling and FSGS would approved. will same

would happens carry whatever at approval of time through. the So

Yigal Nochomovitz

the foresee quarterly, be to And would How you does thinking next pathway at that like on go then it Or annually? forward? it assuming that do be going step the point, could to nothing?

Eric Dube

Yes.

to Our remove. to plan second, has always been X-step process, modify and one,

quarterly, removal able next the get REMS. to the would to assuming are of So we be that step

Yigal Nochomovitz

on past, you may going the in it incorporated are to answered FSGS? going there some one then is the FSGS, assume have fair simply to is pricing, scale twice be given to economies the dosing but of be to with there increase Or on it's this flow in price? the And that pricing discussion

Eric Dube

Yes.

pricing broad that the we FSGS of approved. nephropathy, if could because IgA like are is of access really our first to FILSPARI benefit from strategy assuming community all, mean, I So broad ensure patients

So talk are for at. talk I bit different in specifics, Peter it's look the It's are dynamics but a including certainly something what will dosing. about FSGS, little premature we'll in us to that have

Peter Heerma

most generally, proposition this different is the progressive it's disease think FSGS as I probably value population. patient mean, the I because need. is a remarks, the in patients different and well unmet as I highest mentioned glomerular with prepared in my And

from value our here value price well. we But what doubled So end double the is FSGS for higher pricing I We're really scratch. the dose, is. start with the initially mean This focusing the well. proposition to indication. may planning the is proposition that to we we as up point, and linear as potentially as on something were first have don't

now and proposition we lot for a value refreshing work of already. done been launch. FSGS But it the So the has potential rebuilding are

Operator

Our of Cantor. line Agrawal Instructions] [Operator next from question the from Prakhar comes

Prakhar Agrawal

So what perspective there remain the path readouts to are in since approval coming approval? approval to X accelerated drugs need now? over Can the show a X will competitive full give IgAN to have next will will how space And lot of the competitors long in open get your the IgAN on you years. accelerated X

Eric Dube

it to satisfied potential be said, Yes. might for with really that turn probably that answer very not Bill, to predict. I'll thoughts. us one you over question, for you a With difficult any It's good our it's because

William Rote

will which sufficiently need where the is agency that unmet authority. lead-in, that us the we Thompson is met the said no and approval a stay accelerated speaking a it's nephropathy this at the for some podium will has appreciate can viable Aliza I make IgA longer pathway But in point know that at I open publicly, been the speak nephropathy. Eric, where Dr. has do indefinitely FDA, to not pathway. Yes. that patient judgment because isn't with for point, the for IgA population the

distinction. to So at point, some are they that going make

to the have armamentarium drugs certainly in treat have disease. X that have approved this that increased We physicians

to think BAFF there. of of get that initiatives many those change like too B-cell that when some able on you, are don't I approval occurs. we're got expect I but the that see be you've pathway, And to certainly, accelerated APRIL will an watching

Operator

Our comes Mohit Wells next from of line Bansal the question Fargo. from

Fadi Ahman

is This Mohit. Ahman for on Fadi

fragmented patients market. that expanding highly the the know I can So on the the you approval prescriber treat? number about after a base this average is some of give point on these prescribers in new of IgAN, sense full IgAN

you've launch. I in So targeted high earlier the imagine the prescribers

So on potentially prescribers there's to coming lot depth of if trying now. that the understand to just a new are

Eric Dube

Thank Peter. turn to over one Sure. you. that I'll

Peter Heerma

Yes.

their a patients. I would in that estimations. mentioned out to nephrologists and U.S. access practice, we But X,XXX volume nephropathy say, the net in universe patients have more as yes, across X,XXX our X to To depends we to broad in would well. you to XX,XXX of broad both I heavily. those treat offices target academia other get offices of it IgA as but nephropathy patients community IgA targeting XX overall, As nephrologists are point, have the higher about of all quite well general, approximately the about so past, we a cover in say, your as of, cast have nephrologists of XX% many And you have to you those see -- like go on the nephrologists.

Eric Dube

therefore, substantial and the Yes. really a as a that. is of within opportunity think step community, Thank breadth, thing if unlike for to type many of the nephrology rare other Peter, diseases. see grow you, you come. back, reaching centers. rare many number that the patients patients I think much by explains I quite that signal to why of concentration other Peter's add these One There's is broad don't a to should we And more from which of a continue years referral quite is see small diseases, what that I being have going different patterns in don't take would quite -- team within treated you we signal

Operator

from of Greg line Harrison Our question next from comes the Scotiabank.

Gregory Harrison

thus from REMS FILSPARI,Â and comply may the to can't the maybe receiving monitoring who as potentially liver currently speak a patients you initiate commercially aren't treatment onerous? as impact after modification potential the far less any and REMS with becomes Could

Eric Dube

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

Peter Heerma

obstacle It's could outperformed those have what are Thanks, it compare patients is especially compliant perspective what Greg. say, if a we or far, even do? the their been the your Yes. have so notion an FILSPARI and main monitoring question, broadening say we of though will hear additional is have I FILSPARI would you the what to impact I'm preconceived FILSPARI would only a performance modification that upside REMS REMS.Â Â To REMS that monitoring. you the to be what quite that a that eligible recent be of benchmarks, REMS, mean, for I good the would with has have an question. think I patients I not if benchmarks they easing like didn't that sometimes physicians physicians would and patients they for as from monthly thing what monthly well.Â Â That's be I compliant expecting relative

broaden go for you and physicians, would the the X patient to that that's very If monthly selection the beginning, see why opportunity. from I really

Operator

of the Zemansky Jason next comes line from question America. from Bank Our of

Jason Zemansky

the the additional Congrats hoping And on you biomarker. from was least opportunities any I see I academic as maybe a there maybe awareness providers. guess, of headwinds color activities Curious seem know, potential at if FSGS. the other as on support, community. mentioned know, I smooth could pretty don't more adoption or, to some progress. based broad in bottleneck proteinuria But Jula, you regarding a out? provide be expanding prelaunch your broader in to this you PSL, I

Eric Dube

first to will preparing about over team doing. team you be talk to I'll Jason. will hand question, the what her Peter, Jula for your about talk what can Thanks for. Sure. it be then, And

Jula Inrig

Yes. question. Thanks for that

the educating might term, we practitioners know a eGFR proteinuria even to our it around we around treatment long across well is spectrum But relationship progression to for a a over That's kidney I to it PARASOL what kidney Peter not reiterate noisy failure. show just That's discussion. pathway to think that you challenging term.Â Â And short kidney And rates of it but and education reinforce in to effect is reduce minimize can that is reduce turn we and reiterate of of for and really if what we function can the as that. how it consistent in is that over with just failure. of really aspect you the the continued as treat both if continue important I'll you so to what we're need over reinforcing biologic loss private the proteinuria, our to can continue key good be and similar with to academicians, rate patients. see DUPLEX to and DUET in data. And with saw that

Peter Heerma

and question. Jula, you, Jason, you, for thank that Thank

As largely an are I those same are that as targeting base over FSGS in XX% mentioned we earlier, the today. like prescriber treaters overlap FILSPARI. There's physicians

among nephropathy. familiarity for the in already our well.Â Â I our FILSPARI those is already physicians. FSGS that have to talked brand we about as you continuing and building many already. allowing while with in importantly also a is rapid uptake organization, most a FILSPARI for the high upon And there are think I IgA experience growth established So awareness trajectory physicians

we best pre-marketing that are earlier, talking we we we the the intervention and so with From are is think for out third we about right recognize journey IgA getting And a communities.Â And points. And the with regards that assessing patient I can and to the then aspect and value building really I well FSGS the that now. really really there was experience that that learn nephropathy. is for assessment really the payer are what perspective, patient economic different are and focused covered there is story FILSPARI FSGS. what work like patient on health is

of think the prepared we FSGS initial summary, lot a originally. as already by for FSGS of the the at I end in has been we be planning of work approval indication earlier, mentioned as this started for I As the But were year. will time well

Operator

comes line from of question Stifel. next Alexander from Our Thompson the

Alexander Thompson

you on sort Phase might gears III bit there? on more when made I update. talk shifting guess on the about and the that more little progress a we you've the to on timelines Congrats restarting learn pegtibatinase. the Could of

Eric Dube

hand I question you. Bill, on you. the Thank pegtibatinase. that one appreciate to over I'll Certainly.

William Rote

Certainly.

process we in restart date.Â And the those really point have to and ones And the efforts with necessary progress pretty HARMONY we have from scale-up. calendar before the in enzyme. challenges that's pleased the that, to CDMO we are with before. be And specific I a have As experimental and path data-driven don't scale-up We're on aware, externally partners on you're comes the that going observed enrollment specificity recombinant we'll seeing the been seen up clear. through on have scale has we're XXXX. that work more in manufacturing the how manufacture that partners expect of improvements to our worked the in to the point data to where have with

Operator

comes from of H.C.Â Wainwright. Arce the Ed Our next line question from

Antonio Arce

on Congrats another quarter strong progress here. of

quickly. get So here in X to try

regarding pass and on on PARASOL about about activities this talked that's wondering basis?Â And I little a then but given just from this drug, call, secondly, would the be know I'm FSGS findings the first that approved bit patients. we've obviously, Obviously, the First, overlap talked pre-commercial you've in the XX% findings quickly this with if questions is, for panel now FSGS, you of expect there first the regard kind on to to sort presented pathway that has comes PARASOL.Â Â And it challenge rather of the itself would to based is from specific what so anÂ ADCOM, question the the

of wondering strong to be start.Â And structural be uptake overlap you components SG&A between just launch that's the how some launch around that focused lastly, the year, wondering considering happens? end what really So to the indications, would you itself. X the specific from on would rapid investment given But when ensure additional activities much the right then the if

Eric Dube

the take for much then theÂ ADCOMÂ question for I'll SG&A will the opposite and order, Ed. so questions, in Thanks Jula Inrig. incremental. leave The to I'm them Okay. going be

We infrastructure. have the

There regard once lot and We spend, activities, readiness variable that's lot approved. will pre-commercial not there. pre-approval. be And if largely going we the is a With are occur some of planning. promote about but to so a are to we do it's

really really the in field. team physicians, They're as of outlined.Â Â But patient a it's preparing understanding we've got the got needs journey the with They've a job, and additional So in Peter trust, of help and about the the place. identify and profile relationships, and that to said, the going Peter in establishing FILSPARI. is that of as the patients to IgAN. that's treat and And

the they desperation is repeating approved past, to different mentioned is And something question know think were this think is be FSGS.Â It's in There how largely urgency the nephrologists really I FSGS. on that bears activities. very IgAN. patients than there it in but one trained an I a with that is treat we've on for to really thing So

Jula. So turn I a if play to that's dynamic question the that, out about is I'll with we that think to to approved.Â And theÂ ADCOMÂ questions that over that going are

Jula Inrig

Well, thanks question, for the Ed.

overall part any to big understand therapy. the of education anÂ ADCOMÂ is helping as as of I think new risk a well the benefit agency potential

to what's proteinuria is the the So sparsentan? that an asked already within translate be And patients does stakeholders was that meaningfulness what reduction what the is of it's for similar have key some clinical will seen into?Â Â And there. of also FDA, done the community that you and questions that who is nephrology PARASOL magnitude of with for the just been realize when have not ADCOM, other it's

of agency and and data an it So back key opportunity including and patients. us gives evidence hear the all discuss from stakeholders, to the

Operator

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

Victoria Prescott

and Call. our upcoming everyone, Thank Have seeing for to XXXX Full-Year you, great everyone Quarter Financial rest forward a joining look your Fourth Chloe, Results and day. conferences. at thank of We spring the you,

Operator

for participating. Thank today's you concludes conference This call.

now may You disconnect.

Travere Therapeutics (TVTX) 20 Feb 252024 Q4 Earnings call transcript