TVTX - Earnings call 4 2023 | Travere Therapeutics, Inc.

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Operator

Good day, and welcome to the Travere Therapeutics Fourth Quarter and Full Year 2023 Financial Results and Corporate Update Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference call over to [indiscernible]. Please go ahead, ma'am.

Unknown Executive

Thanks, Jenny. to Results Fourth and welcome Year and and Financial XXXX Corporate afternoon, Travere Quarter Therapeutics Full Good Update Call. for all you joining. Thank Today's by Officer, call led and will Executive Chief our Dr. President be Eric Dube. in the Eric will be prepared by Dr. remarks joined Peter Jula our Officer; Chief Officer; Chief our Heerma, Dr. Inrig, Cline, Medical Chris Commercial Chief Financial our Officer; and Bill up session. Q&A for Vice of and Research President Senior the Rote, Development, join will

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

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

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

Eric Dube

of and IgA IgAN. treatment for At approval the sparsentan the Filspari, from many non-immunosuppressive Thank first start our historically you, goal [ barriers option we first rare delivering achievements down for great was XXXX, with or nephropathy of as gained Ann everyone. Travere work living little year innovation. welcome, diseases ], pipeline, as people our or breaking and and a the we of towards XXXX with treating only

options. with and average treatment For IgAN, their years and are kidney XXs of XXs, in and face failure on limited XX most decades, whom in diagnosed living people

foundational diagnosed we patients will We lead the ultimately treatment reduction are that of get premiere the ultimately and superior earlier kidney utilize of physicians with and accrual help evolution where initiate as paradigm its believe will proud treatment a to benefit. and preservation treatment see growing Filspari

accelerated our comprehensive commercial and I Filspari with year a our grant to strong launch am team approval, quickly for foundation our lay the the throughout very uptake. Following of work results. pleased plan initiated

net We continue that and payer the launch in out launch. in Of aspects better challenge quarter the pursuit each first in Filspari XXXX. Last we the to substantial sales rare has kidney make and to growth consistent space community. inflection we its demand is encountered year, progress close physician FSGS for seen a in the coverage demand, of of product year, revenue, a outlook meaningful a in only saw note, key recent our in the

to we our Specifically, achieve a to results the am sparsentan not had Phase therapy of we FDA the treatment I/II data would for the where Duplex time. further did submit available, FSGS disease-modifying was potential hoped. the at it pegtibatinix believe from incredibly may which study X,XXX over sNDA and And this we better following or study, with future alone. I the year, diagnosed become exciting to time be homocystine results in the in generated with our homocystinuria, only investment We an based at collaborate grateful grow there and goal of restructuring efforts quickly our program, of Travere this how COMPOSE and align XXXX. to our learn identifying effective diagnosis, quickly with demonstrates are HCU, a our resources Globally, proud to focus is XX% to more and adjusted. by a patients levels. or of XX,XXX HCU forward colleagues who clear not in are full position we that control on an the believe we regulators we important implement for potential a our path our With achieved engagement, in classical of DUPLEX regulatory future. [indiscernible] moved in concentrate not organization additional in for Last their milestones strategic HCU.

data, on closely worked with With initiated regulators primary we year-end. a reduction total a these homocysteine utilizing III endpoint Phase align to and study before that as program,

expect All our and Strong in board. Filspari the of with for half launch top from the our our and to the start second focus priority year. in of plan across XXXX efforts last for year performance new continue remains the XXXX positioned us launch XXXX a execution we will into momentum

Filspari the rare an being disease need enrolling to and cause and In raising this trial of be leading Phase of our together that and we with note, we in are XXXX, to optimistic We're more at to forward priorities with access evaluated Asia, Filspari full for other failure. broadening We homocystinuria, of aimed expect Of kidney therapy an innovative [indiscernible], executing on in investigational looking to on agreement of our for disorder. positive. even quarter approval opportunity the X approval HCU. U.S., we CHMP support also have will conversion regions track for our on our aiding sNDA opinion treatment Filspari approval Filspari. pegtibatinase, in this access HARMONY later classical are IgAN III plans importantly, CSL novel treatments conditional Vifor, are for this about to will our on where prevalent from the we recent accelerated are Europe to additional enzyme development awareness enable And at submit with in our with their focus excited And this quarter. ultimately partner, replacement Japan we or IgAN for is be to the

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

Jula Inrig

clinical last diseases XXXX. with options are with progress you, medical achievements ultimately I'm new and our Thank affairs available. X initiatives treatment standards rare in positioned our to we afternoon. good in and limited Eric, very pleased made With year, on well the deliver

our IgAN. bar a It's and active in space setting FSGS highest robust as we periods kidney highlight cities comparator, in the important presented double-blind demonstrated results, Filspari, preservation that in the As optimized to function journal, ones only the and studies for presentations the reduction maximally England simultaneously and Journal are completed the dosing our proteinuria that for X-year in The world-renowned in the medical of New at and Medicine. published Lancet which late-breaker IGAM ASN clearly were of field. use

that play dual positive pathogenic simultaneously is the of preservation treatment a I nonimmunosuppressive Endothelin eGFR Filspari there presentations, nephrologists X only on compared those X IgA maximize that kidney have role resonated is function kidney have in damaging on accrual minute In received therapies, the irbesartan. is about the kidney Filspari function the from proteinuria time. drive X.X Following Unlike benefits benefit years. greater short-term data molecule can for the long-term function, the And and in pathways that key increased sustained together EGFR that Filspari to patients angiotensin order reduction at function kidney. that Filspari accrues which action blocking kidney mechanism intermittent to favorable inhibiting approved minute the nephropathy. What damage benefit EGFR. of long-term absolute X.X pathways we PROTECT per with by per nephrologists mill to demonstrated the foundational critical in to ml with achieve IgAN with and it's in long-term X for loss. the only and on at may II, is kidney effect titrate work that was year, works study preservation and over Filspari both feedback a

a has their in facing injury year lifetime kidney function the longer-term important of who a may slower rate otherwise additive for accrual failure potential significantly benefit kidney treatment. was X X year-over-year and patients, of suggesting loss over Filspari This patient diagnosis. Importantly, from of XX to with less years year than ongoing be kidney benefit compared is for

play shows the disease Study at to that academic rapid and and data due RAS are use is uncontrolled X-year progression see the foundational the to proteinuria. where chronic care is in and We Filspari critical of highlighting patients safe Filspari cements Community treating historical early with from is for continuously the Filspari to as inhibitors experience life. can Filspari, Our safely this which replacing nephrologists inhibitors superior those they with ability us believe role to by PROTECT that patients our use, reductions IgAN clinical significant risk for chronically. in for proteinuria RAS in

for Following the plans pre-NDA our positive track on this potential labeling. broader we pleased completed a IGAM the successfully submit remain to quarter. convert to and to that approval we from the Filspari the PROTECT, results support to support to FDA to FDA aligned approval we data Importantly, full submission submit our to report with I'm sNDA on analysis meeting to discuss sNDA from accelerated an with

juncture treatment focused at further damage We that are are treating damage on of preventing paradigm. We believe then the evolution an the the in exciting IgAN systemically. the nephrologists kidney and in

is goal inhibitors ultimately Our as the medicines needed. the IGAM of foundational then as care Filspari be to RAS used essentially and can replacing added role historical in other have

label can study continues, preservation. full provide help With that we full of with number choose kidney function broader nephrologists the a population that this we evolution are would this Filspari would treatment there flexibility patients greater when reflects a achieve long-term Filspari a that As to This the options will factors results. seeking expect and expect approval goal. FDA, and from provide

released be with guidelines Additionally, in inclusion further treatment. likely Filspari KDIGO of nephrology standardize the to earlier should and soon a we believe community use potentially result Filspari in

in positions we be described treatment foundational IBAN peer-reviewed up-to-date the and as will Filspari recent a guidelines. KDIGO As anticipate in articles, treatment

overall long-term would later we combination earlier are as further use inhibitors, the other data target safely our in may and Filspari for with from ongoing also combination patients studies, [indiscernible] as benefit earlier aggressive medicines, proteinuria foundational Filspari to treatment from well which Filspari. care. as treating diagnosis, show Such support more will believe IgAN avoid such which to treatment will that used the the data year, We this be can achieving and designed of expect that future. Furthermore, lowered, longer-term to SPARTAN in towards damage be progress generate SGLTX support

partners we application work marketing have is U.S. closely with that evaluation our U.S., the in the CSL at Vifor the currently authorization conditional continued Beyond on to under

and the procedural X-year quarter. data, we Following to believe well CHMP approval a are decision positive stop clock for review quarter that we positioned next opinion this an a

regulatory in agreement to Renalis we in recent and our road Overall, territories, pleased IgAN utilization the for with a number potential XXXX, clear map has Vifor with and of Asian late CSL coming deliver see Filspari groundwork a Filspari provides of with across that Filspari are a pathway increased important beyond. we very the for XXXX Beyond years. in the the countries

to committed Turning therapies of a condition are high progression of patients with for trying briefly thousands and kidney path find for FSGS. to tens to of FSGS. approved sparsentan forward the With rate failure, to this no and we

are the being a this update in approach provide We of year. taking FDA have data with FSGS to our able to reengage year the the an Filspari this anticipate the an to able We to measured goal working ultimately indication toward submit being later work community evaluating to to on added the label. and late sets

is highlighted which HARMONY measurements pleased earlier, provides COMPOSE a as employs a with endpoint. how we protein This study have liberalization increase eligible We the data Phase prior patients to to Masimo's This Eric study in patients design they III full highly XX% period HARMONY to effect to substudy the XX-week ultimately a will with to the the homocysteine double-blind as the the diet success This primary of registration-enabling achieve continues is intake able to area design total double-blind alignment study be to and study. The total generate And highest enthusiasm consistency in XX and the and of help designed XX to and for Patients program of for throughout an be probability a were is grow. is will be for by of understand portion who we our dose homocystine. evaluate year-end. safety able total As need III pegtibatinase, diet study, change III designed and patients we enroll robust HCU with [indiscernible], called of innovative durability up into be there before I/II our randomization the XX establish who which it life similar is complete database. believe initiating open-label in week our stabilization to Phase the may followed living key to baseline the from program an and a pegtibatinase taking goal will patients successful patients to of X HARMONY. to HCU. Phase high with saw of protocolized study our period screening on there the to where reach in well-controlled for very Phase recruit in reduction a eligible study believe measurement to study. period a weeks regulators cohort in

we manufacturing full in future through study up to the forward activities Peter? call As XXXX, in XXXX the we in Peter data a over pegtibatinase the ramping commercial will line on look be and potential the move HARMONY top our program to and turn commercialization. update. scaling support for enrollment We to approval focused XXXX. I'll now with

Peter Heerma

Jula. Thank you,

I'm patients care launch the demand and efforts and breadth made experience in the educational robust in nephrologists through the on during U.S. In physicians. made study to our we built end back a what reached Week, year. patients with with while fourth risk initial the Kidney access patient to the addressable in year. the as sales of nephrology strong and for unexpected base I have further regular interactions of that future ended and be for quarter, our securing especially progression depth of steadily rapid in team liver XXXX, advance targets, [indiscernible] published. educating And promotional in foundational see initial patients about couldn't an for with believe outlined IgAN of or increasing our XX% ensuring has progress the we program treat our February XX% increasing ASN of our nephrologists. of is come adapting new and for demand, momentum strong we and call positive of presented sales last proud team how after face-to-face encouraging on broad growth X,XXX nephrologists PROTECT X,XXX forms really commercial prescribing were accelerated and in Looking XXXX, where we These the pleased restrictions progress at start It with approval Filspari we the particular, that monitoring. By resulted confirmatory we past that the more was year. results PSFs target in

PSS, the quarter we Filspari the by leaders which opinion also quarter-over-quarter with XXX of Importantly, received further [indiscernible] each profile period demonstrated evidenced which key leader from increase growth an fourth validation in was ended XXXX. prescribers. We new for in

a rare we is first first the fill this Filspari continuation product which growth forms fact, nephrology year need of each first XXXX, a In nephrology more has start demand of during total, In is shown the of indicates in recent that than X,XXX period the clearly patient for received the -- helping significant launch. in community. in

are XXX the than end established On year, a about of access. strong include base added that day would lives. broad And the XX% specific is about account for label. new [indiscernible], Filspari Filspari, reached coverage consistent of plans yet if pathway we we overall, a the authorization that allowing the lives. Filspari to By included for XX% U.S. with total clear about In the front, this criteria of more didn't U.S. patient formularies X,XXX And quarter, payer generally first have have formularies. we fourth the

and significant Filspari. results impressed daily fourth progress trial In the sustained learned in Following net robust that saw in the the XXXX. initiating the the encouraging throughout in in during foundation product physicians in contributing we also measures quarter. similar Filspari in what improve may our reimbursed rapid hearing million net a compliance patients XXXX was recently further that a we first with support steady, high increase of that we liver certifications how our All a provides likely quarter, product consistent continue to results profile achieved are is days to accomplishments ended growing which rates of us of million monitoring a and reported start year. This sales reductions with And and for for [indiscernible] a half These of patient that seeing impact in led continued sales. We after also started to safety receiving and using they team's approximately strong quick in sales, with REMS Filspari they therapy $XX are nearly to patients inhibitors Overall, an are net second patients trial in PROTECT why in year. this generic for the number the performance education ramps we observed with resulted what We provide the so in with and a in and $XX the remained see on quarter. the to lead base $XX for. versus the and approval these proteinuria almost patient in adjustments of monitor ARBs. This XX fourth are approximately will narrower solid for million execution, later, with the have year. loans. resulted we far we ACE

in X In strong year, see the performance first continue. fact, I'm our star of pleased the weeks to Filspari new

confidence team and is multiple inflection XXXX to this Our year, in of in provides we the points throughout that new ready show continuing Filspari potential true growth. have

highlight in about am the year. particularly that me excited the X coming Let I areas

that prescribe an full achieve support for we updated broader patients. for later label physicians their this provide we of more approval if First, targeted and as year, Filspari to anticipate greater will potentially

updated physics will Creo that uniform as included Filspari guidelines, Filspari global an treatment will of Second, to provide as in scheduled be patients. early guidance Jula for be choose This this anticipate to potentially mentioned earlier, the we their year.

With broader likely the by that believe of diagnose intervention earlier. lowering and the evidence We support patients it medicines physicians fourth, would may patients for treatment target highlighted the would the Filspari earlier to expect patient available will need additional clinical together earlier combination additional pensions for that the a and other increase number earlier a Jula And larger label use ultimately provide with earlier to in Third, we addressable and significant in treat Filspari's us as guideline with and excited year, positioned new the a XXXX. in we it could Filspari mind, strongly this emphasizes Filspari, in proteinuria would I to for treat treatments. population. be importantly, this additionally, for aggressive urgency potentially with about more to eligible if more all foundational prospects be establish would treat are this in guidelines, feel not in amplify growth revision lower we well a that targets, allow of

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

Chris Cline

you, Peter, everyone. Thank good and afternoon,

program. quarter results, strong Filspari perspective, position. continue on fourth we grow our in our the our IgA and and financial Following we focused are an investments a III nephropathy advancement to pegtibatinase the launch revenues, operational of From ongoing and Phase of we have

quarter increase net product the the For for net from were million in nephropathy. XXXX. compared of same fourth and $XX.X the is of $XX.X product sales ongoing XXXX, to sales attributable Filspari growth IgA in period launch to million The

of III pegtibatinase $XX.X the license also program. were same continued advancement of we same period from collaboration $XX.X expenses On $XX.X million million difference to largely in expenses is $X.X by the general programs offset million the compared revenue The compared quarter, for XXXX period in period the the launch-related readouts a fourth the of SG&A X-year reported in development in the to our $XX.X for $XX.X reduced the commercial fourth R&D the of recognized attributable million for Phase same partially is XXXX. administrative investment million basis, the and our compared same During were to non-GAAP to for to non-GAAP Filspari clinical The to for XXXX in in in Selling, largely following period of total in were million the expenses million for February XXXX accelerated approval same million million in million activities following million attributable of quarter and difference XXXX for which to adjusted for a $XX quarter $XX.X adjusted endpoints. the XXXX. Research compared quarter compared and XXXX. of in of the quarter XXXX. On the results XXXX. Filspari period $XX.X XXXX. for basis, were the expenses $XX.X fourth fourth the $XX.X revenue period

recognized amount operations basic per from compared non-GAAP loss, basis, compared XXXX. or of $X.XX related of reorganization the this $X.XX quarter, the a million strategic the in net to share for was net we including Total for fourth announced to million fourth share interest fees $X.XX to is Net in basic expected same income loss discontinued During million XXXX charges or On in Total in of to the million. was quarter the discontinued quarter during operations fourth an of to the per million for fourth $XX.X and reorganization same or loss, restructuring million December. attributable adjusted for share income difference net the are $X.X in $X.X per $XX to per XXXX million $XX.X period. million largely of net period in $XX.X between quarter $XX or a other to the XXXX. basic for XXXX. million $XX.X period $XX.X loss same $X.XX period increase to XXXX The of including was from compared share related the basic a

and December of cash XX, XXXX, million. $XXX.X marketable equivalents the of As securities cash, company

million Looking Filspari non-GAAP the $XXX and ahead, of product we expenses XXXX, year. meaningful growth net for in operating in achieve below to sales expect look we

our anticipate XXXX. I'll We now closing in payments Filspari net year. With making his growth over balance revenues investments operations for and can the to $XX of expected we that expect turn cash Eric will Eric? also comments. Filspari our result back sheet, in both measured approximately and during it into support currently milestones strong us million meeting for that pegtibatinase expected the balance

Eric Dube

Thanks, Chris.

of are entering Travere. growth phase a new for We

these kidney potential strong global are a in to $XX projected organization positioned respective with coming for Moreover, exceed well pegtibatinase rare Our foundation as disorders. the is billion Filspari markets future to treatment metabolic years. their financial and and continue collectively advancing standards

desire by little and historically their continued deliver who our drive our on unrelenting see the long-term following: for HCU is Our the based innovation strong execution FSGS, to life-changing near-term of therapies and growth no of expected approval for Filspari in conditional U.S. in the EU reach data IgAN broader patients launch, IgAN and of Filspari approval potential labeling, with the full growing in to sparsentan people the We IgAN, of treatment potentially to to and number a condition. need the affected generation therapy. have better through had guidelines updated further of

excited development Finally, expected grow of enrolling only the about achieving the goal pegdibatenase in data top in to raising as Harmony study a therapy I'm with that particularly of line market advancement disease-modifying year, Phase look XXXX. our potential meaningfully program This of the awareness to HCU time. for and III a we is forward over

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

Unknown Executive

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

Operator

[Operator Instructions].

Schwartz We Partners. Leerink from will first Joseph now the line take of question from the

Joseph Schwartz

seem resonate hurdle performance on have the higher ask this do does much the had protect? is them? in patients managed. control for were PROTECT education to Do appreciate appreciate prescribing to that they order Does Filspari the and Filspari, in that trial relative Filspari Or I'll so them in arm guess impress with the you to well do more to how I community.

Eric Dube

design. coming of and out was Peter, question. more trial the where don't much there on and ASN about you we Joe, saw trial the thanks PROTECT that comment so for I perhaps can discussion over you, turn what to much also why

Peter Heerma

the conversations to think saw. the of year. is the for like arm design robust But And then it in earlier active we -- per of Yes, that results and the per question, I appreciation have. mil say take market outline with have physicians, per research is for in highlighted that if I an the And I have with and minute minute Joe. X.X I control really line being the like call, that's you understood. that we also year study understanding improvement. second like great in results PROTECT would have per X.X year, we actually million There's the the very the

benefit of think the So over [ speak they an accumulation design understand highly I if is of. that physicians really that something And ] time.

Eric Dube

there anything ] that team's bar. thought on is like comment design and trial the your you'd high engagement [ that leaders Jula, from with to

Jula Inrig

Yes.

I fully know which XX% trials think a does the trials higher hurdle. are the comparing other optimized really it have [indiscernible] historically aren't take to all not [indiscernible] all and other education some standard we because a we

X And once data spend that the some but so continue information. when accrual initially if you at benefit they that's of to in at look know time see year have and get year with comparison clinical year-over-year. snapshot, the and most you the of look can then they We some they going their the X, slopes, a that to the takes then That also in X-year to it better some don't it benefit improve see. a that's in versus does the we take they practice, time, only education which benefits but did

Eric Dube

eager really such see a about this help that to X great to to we very part and the benefit And we're how full going that allow talk approval and does design why trial a label important I be is think results of us why long-term throughout will the explain years. have

Operator

Our Bank next question is going from come from of to America. Harrison Greg

Greg Harrison

Or especially way Just it for treatment say there it should when a be through better treatment options, the investors EGFR light is to that it? think to benefit? about fair in comes comparing of landscape. IgAN to the focus data, recent on the different And thinking is

Eric Dube

Greg, thanks so question. the for much

leaders more importance treatment is she of as Jula? from hearing eGFR about the think and and answer about a short the a nephrologist and let I thought no. landscape talk very But I'm what going Jula what she's the bit evolving proteinuria. to

Jula Inrig

both proteinuria I'll for that we with over time. for patients and for at matter take of regulators is for proteinuria nephrologists treatment highlight First, and well patients, to start as really and evaluating but how for I'll response critical as eGFR, looking care risk

endpoint say, between would failure, as for many When more multiple X.XX know to to an As and show why eGFR a risk approvable can they grams day. still occur at correlation also normal importantly, close changes possible. show strong versus get it's to of patients the time we quickly require if as changes you accelerated And reductions over remain that we I that's at approval. got the And per risk the rotary kidney years sets need rate proteinuria [indiscernible] data look effect.

Filspari getting closer of normal to and So proteinuria. proteinuria in realize X with on achieve remission we [ is to to very ] patients X saw patients regards important PROTECT, complete

and over in far reductions time. proteinuria that preservation [indiscernible] so eGFR both And accrues

think So take all consideration. those are factors to I important into

Operator

Our come question Anupam Rama from to JPMorgan. going is from next

Anupam Rama

more bit guidance should about thinking first and about we in any about of considerations as the of kind think be little the a seasonality we an in how Filspari Any payer a reauthorizations quarter? acute And question quarter.

Eric Dube

thanks for question. the Anupam,

Peter? think Peter's the and dynamics year more about Let you me that team done bit we've those for to really that of can has it strongly, not turn Peter not recognizing in more talk what don't just why some I starting good we've be providing detail. and expect guidance. QX, say certainly, will I in those over see we first job dynamics seen talk But about performance a a Peter, great to to

Peter Heerma

momentum -- across well. in paid weeks of continuation really progress But Yes, also allowed as like year And the I I saw a we we [indiscernible] ASN, substantial getting the saw Eric. prescriptions, think product. see increase though a building and first made I in product of fundamentals, our particular I really earlier, as in like like X this the progress from core happy we launching that that progress fundamentals leaders. across an good the for X think of in we patients on particular, to think, mentioned Yes, that of the

like I we think criteria, reset to your gross insurance the net first the and more quarter. specific question, is in for what to reauthorization move the

this first learning. so Filspari, the we to be going is launched While new year a that's

fundamentals, So really if we don't yet. know that I'm at progress been have I we pleased look But the the making. with

Operator

Cowen. Our TD next from to going Tyler Buren come from Van is question

Tyler Van Buren

does IgAN, the removed. can that as end sNDA the describe full revs the include supported a So by quarter you you if and to Filspari that to box approval of request so, of And how part have black the and warning first submission for us request? of the

Eric Dube

I much And Tyler. the So Bill, you . that seen a don't you to of first Jula, from for we've during the engagement FDA turn process. about add standpoint. the can what we're safety sNDA data thinking with to certainly, so why question, talk terms then, thanks in

Jula Inrig

to want to for [indiscernible]. on development we've launch some commercial in I year have had several who had after trials years, cases So first XX and including of patients treatment across that program our highlight we our

further we do I may isn't our going [indiscernible], press historic certainly comment for the [indiscernible], of Now that for are process. removal advocate process the which on patients, note but there for best to

William Rote

Yes.

begin data don't Both in modification a We be, update, the With really this to anniversary agency. REMS the begin with the safety around us collected first submitting which need will the now At the the and of our have start to this highlight will the the sNDA response but end we'll to know of and day, us launching the have liver the dialogue dialogue. the important data give around to REMS conversation these study. the full it's of we annual approval, quarter, that point -- of for also PROTECT be what X-year we data submitting the the potential will we've be interactions the those the we FDA's and that give we'll which program.

Operator

Barclays. Gould question our will Carter from And next come from

Carter L. Gould

seem on momentum more inflection those mentioned of increase that guess what until it form of I weighted. hit, is expect I'm points farms that sort of new new understand mentions those or color be forward modest. characterization was we sort of call to back-end The fair and inflection Peter A the going should somewhat does appreciated. mid-single-digit in increase a like trying lot would probably commentary Any of start start are there.

Eric Dube

will the we a on bit detail approach performance, certainly a what can year, expect that you forward. Carter, question. some providing the do start moving year throughout we strong to about we of not to demand patient see thanks more But so and to both Peter, guidance the to why talk of revenue. for can particularly say the don't for in in much and we those expect expect our see directional but see I'd for speak year that qualitative forms be Peter

Peter Heerma

the for Yes. Thanks, Carter, question.

think last that in base very prescriber of take the the I into characterization low to a have it's had XX years. it you innovation context that XX to

so the we're continue growth. think in is that I showing that think broad out think prescriber growth earlier adaptation, within quarter this in where And I every in the to year, first what I is I the context, And community you basically base. first and it to takes the that see time the and that our educate recent [indiscernible] called get the QX

a we more I the momentum think in of The guidelines that as to show this growth in updated well. that patient revenue start data is importantly, be year. good and continuation something to is that expect forms ultimately is

used that's experience and and you that understand I with that's have requires we what bring that best we consideration And the maybe but seeing an and further really think are they is with education. advocate are are use I I So prescription. is to audience right into question, for think not further your that right And now. gaining, to the definite where innovation now

first I'm plans the the year, So think saw, I in continued that pleased growth to really have the we with.

Operator

to is next going caller Mauray Raycroft Jefferies. Our from be

Maurice Raycroft

you you expecting the to but then For like led initially EU, the clock you're the it approval, which EU, that's data and submitted for this the had conditional to sounds X-year stop. quarter. filed what

it any that full your possible EMA that? provided could approval for guess the will Or there EU? and be conditional, X-year possibility still feedback you it has get any is in data? after So reviewing is I

Eric Dube

Bill, the I over Maury, thanks so will to question. pass that you. for much

William Rote

quarter. of about equivalent they look data making we regulatory CHMP that the are listings be package with remain EMA potential because first there made aspects I decision of full accelerated risk top weren't the and X-year line helpful figures a this full the removes of more Well, provided discussion Sure. the data. approval tables in their at wasn't and essentially a associated approval positive for that it of optimistic will there don't their have The decision yet. the X-year think, was data, the

full with round. this wouldn't approval expect a I So

Maurice Raycroft

And data X-year seeing has it. EMA they've the Got any after provided seen? feedback that

William Rote

this have opportunity the in an that point in dialogue approval. time, feedback at for as I'm No. we we'll sure process There from wasn't go full towards

Operator

Our Tim going next to be Lugo William is from person Blair.

John Boyle

for John is on This Tim.

you sense wondering on as a any last required? that conversion [ the just discuss follow-up, AdCom might approval. date might informed on be And have ] require have that if So any if to to you might agency an the be full if you AdCom sense

Eric Dube

John, you. thanks for the back questions, Bill. I'll that to pass

William Rote

that of think is don't from agency an the regulatory advisory where I type sake Sure. the would advice committee. decision this

data clear. the is think I quite

need also isn't a help trial to there interpret experts there isn't a results. controversial external to So to I additional out aspect for go And think this.

the don't an I Certainly, So that anticipate ready. if we will advisory will do, they agency panel committee. be

or have not AdCom Your of the going to days second they're within part let XX know whether sponsors agency -- was or not. timing. the an of your the question Generally, will submission,

will for by So if AdCom. not we're quarter, going mid- or know going we be first second to submit an to the we whether quarter in late

Operator

from come Evercore question is next ISI. going Our Liisa Bayko from to

Liisa Bayko

be have any the released? more Do when color on will new guidelines you

Eric Dube

Jula?

Jula Inrig

they're this it's but in color the than working we we other in more anticipating means quarter, on finalized potentially were be now, later and know it provide I know We year, but that can't works. the they would

Liisa Bayko

Okay.

rates also when compliance about helpful. And be growth the normalize? can you would thinking that be the you average mentioned with for year? from color of kind are speak And can you good. compliance? Any were to Like there for you describe what kind You of should or year where would

Eric Dube

that to over turn I'll Peter, Sure. you.

Peter Heerma

Chris, the and take to I'll take can the net question gross you on the maybe earn. compliance

[indiscernible] without a It's rate, requires the at really Filspari What far, so high. are like method compliance have strong so monitoring compliance [indiscernible] see actually rates. you testing. a anticipated, disease chronic compliance that look we far, what not see we high. rent than overall higher very if for on disease, liver you very when with program So also is with it we especially monthly rates

first to Filspari, I the time, target And I disease, keeps having. we to to reach they have physician motivating the losing. their see And they they're they actually like know to supply also to control I product the see mean, patients, in from target that levels. use time target. every think for feel the over that's and feel think into the continue consideration the those experience course I hey, lot that compliance a of that they rates. yet like, think high not it patients I of are able they're hear you that on take be what, the And are think now to you with think patients I and is also we their

Chris Cline

to we've And Liisa, nets, been things with just on teens meet seen mid- our a to the how having gross we've gross pleased net. high to of expectations

have expect is overall But to past. that as would of for the to the remain with mid- products level. it XQ some little the the in for be reset we thing may bit that teens year, higher see would other I in we The we year, high a that of say our other

Liisa Bayko

on of Okay. on many how And on all then exiting XXXX can like patients you comment kind at Filspari? were

Eric Dube

any guidance on So not patients. KPIs treated for provided number of we've a

talk we're provide revenue point Peter were as payer the and about I seeing to this the anything PSFs directionally to question? at what to think going on on year. Liisa, launch. continue Peter, ended can updates want coverage further you we to in we provide this But on

Peter Heerma

that's I think right.

on product. all I patients As mentioned getting including we're the pull-through robust progress think fundamentals, base on the I earlier, making

from process the is benchmarks, products. you think expect disease which well I rare would within

it we that will well to point. think be will And revenue I as so reflected by continuation and see Eric's

Operator

Our is going question to ] come from next Guggenheim. Neil [ from DeVan

Unknown Analyst

side. of follow-ups payer Great. a on the Maybe couple just

they the that a little for. I'm remarks they're any, of there that can sort until of more the deviating sort of think, the of -- curious you XXXX the issues, of assuming terms second just detail cycle that terms approval, maybe have immediate the from terms expect if if in of formulary are when would label sort starts raising? give of in what or sort I in we this something Peter, sort more that -- they're later in payers I mentioned the authorizations. prepared you are a label then that? with change So reimbursing consistent your they're of have sort status I wait to patients therapy get the think Or of generally payer sort on is question in is full of behavior XXXX you [indiscernible] year, sort around And up of you acting

Eric Dube

to over Peter, I'll hand those right. you. All

Peter Heerma

to payer label safe regards especially proteinuria where in is label, kind the most proteinuria regards on clinical lower patients with targets. of we criteria and seeing in are to refer With to authorization [indiscernible]. the the I rapid refer was criteria. we Yes. players has generally progression that of to the like the always certain is there's that of and are but disease beginning when with X.X. the guidelines states the got we also When and authorization see think that that expecting to label -- I so mean effects

gig the like allows broad is of powering also fulfills a earlier a broader that that that's company further targets for with the within them point in So for line, for a allow a a population patient label call paid broader lowering is use. would that the proteinuria to And products. my why eligible

Eric Dube

approval they on comment approval respond your and Peter, might review. to how will around is the and able And full how what then, be payers with question full quickly

Peter Heerma

Yes.

I it proteinuria a no then of a said of So little it's disappear. authorization a label, speaks also criteria bit I what pot that atonia in and with lowering to broader think a further threshold whether restriction may on target

a And patient so for that population. allows broader

one that's aspect. think I

referring -- new like is landscape aspect with evolving as question well and another think think to competitive have in. been your competition the I may coming I

like standard that for we study have payer that in how is lead gold products. design. the standards especially a we have highest time study think very only have evaluating new this strong that and a active basically since strong provides mean we the the base the has the I which I is is formularies comparator, position,

how are we a strong time regards deciding position study with as So lead I as are evaluating landscape. well think payers to in evolving that

Operator

question is Alex come going next from our Thompson Stifle. to from And

Unknown Analyst

how the pay to a could I here. this with based I/II, readout identified XX-week of Phase talk well conservative is primary point? at through your expectations patients line news want or around enrolling XX the HARMONY is these little you endpoint you experience patients? bit a top are little XX XXXX least up to Or patients Maybe the a bit pivot If study about the about how on the at bad to are this the thinking that?

Eric Dube

Alex, I'll and thanks that turn program. the so the Jula, pegtibatinase much one the for for focus on question over also to you.

Jula Inrig

on is So exciting at changes XX weeks, design total just think focuses this that thanks. XX, trial We an in not effect. looking but X home durability to also at of

It's line which give who Compose. data started and us XXXX. at overall, to open did a we over liberalization. patients is XX your do list sites So of looking are then which And more sites are look a from able it XX-week patients to top point, to and XX our the we And recruit while we participate. roll will than study in to trial, we is have label, patients diet excited about to from have

then these full also commercialization. have moderating as to initially are our the We ensure we intentionally sites well to our as experience and at -- support scale also of ensure research are good enrollment to sites and some a patients which and CMC proper the training up of for study naive some to

Eric Dube

perhaps that longer line for would the what trial. you a may be of bit it type say period on the can before this people than comment time think I typically helps why for if So enrollment explain screening

Jula Inrig

Yes.

try is end. XX-week patients for their period keep understand and they X-month because chance our trial We that's diet, table, where well of our which clearly going endpoint. and standardize the it impact trial, really have maximize patients their make to your as that a screened chance that is at to So to they success want the run-in we sure a to get qualify to as plus have optimize success diet need

what longer stated. bit a you first it's than So

Eric Dube

the for see patients that in that other absolutely put been in more that in community, of -- that we've to you've explained, Yes. reasons identified, that out the confidence us Alex, being this gives the increased that swiftly and as this, be would certainly awareness we -- is are thing we thoughtful all the look within we've patients that And there a lines more would number we the we'll very around the diagnosed there move growth. that but market there. on only of will growth mention overall identified, and are time enrollment we I expect

that once the and look us believe be something have reach HARMONY for we we a is so will trial this these certainly to we So even with patients tailwind more approval. as

Unknown Analyst

need And to to not I powering confident guess, patients feel like many you you if XX. enroll how it's in do feel

Eric Dube

don't why you patients. I can absolutely Bill, say about talk we but powering, are confident the finding these in

able et been we've to through where think thinking I in help with these are, patients sites, cetera.

level Julie's a how you think success great Bill, So a I has team we I trial. of HARMONY And ensuring of powering. think, can done about the job high the can enable in really talk

William Rote

in in reduction the we're certainly, in total Phase the remarks, XX% powering No, very homocystine study. mentioned I the confident And that she Julia's recall of in was question. appreciate Yes. initial observed the II. and

don't the a with anticipate. place We we size, a the reduction a diminution level endpoint. or effect total achieve that overall the efficacy, treatment in which are with to even sample good still So significant of in in certainly

there. So that I'm get confident we'll

Eric Dube

question, to next we move can Jenny, please? the

Operator

Yes, have hear me? Bansal. we Can Mohit you

Mohit Bansal

know Just at quarter a I maybe but the look I I like then of it substantial to and seems count. from provide wanted number if increase then patient forms, there's fourth But third understand. quarter a the in second there's to quarter, you patient don't mean increase, average revenue. to XX% third quarter

this much part XXXX that? Okay. that last I you the on converting price price price turn due stocking question. involved for then so increase, increase should I we those is are expect Can a is because a Peter, -- to January, patients? lot took in patient will you you. paid Or help Thanks So here? more And increase? that of question is form there over understand into to us some benefit think you in the a in second

Peter Heerma

Yes.

So [indiscernible], for that question.

REMS So that core the that of robust also think quarter described the particular we what and that and mentioned, product quite you based I in the making this patients base on fundamentals is patient some and through in that -- mentioned, within process continue education that to days to regards saw patients patients products go earlier certification in revenue. particular, quarter to as required the paid like in is platforms of like loss and the pocket additional allow has handholding products substantially, progress one or patient the with the rent increased sure to we And more increase XX I first transition get the ultimately as to I I think in made on quickly. you

from think I progress. product. we transition there. To ultimately further many details But Eric's paid So good on that to on how our point, we progress provide patients product, earlier don't we patients significant get made have [indiscernible]

price On increase indeed, beginning we the the of with a and to price regards year. price increase, the second question had in

longer-term the see that Now that eGFR proteinuria robust and and we provides you as data, reduction taking have confirmatory proteinuria reduction the well. -- preservation

was it thought have year. we a this So for justified to increase price

Eric Dube

has And inventory. final question of stocking. Mohit, there been pattern no thing, has so on stable, one your maybe just been for That

right. So I is Peter absolutely think

continue the We growth through would apprise in imagine patients QX. but year what revenue to as of expected is those patient going in the a revenues how to forms, in we're process. this see start perhaps than help that, inflection our you certainly are able that see faster trend end you we'll that greater we to doing at teams with

Operator

Citi. come from And [indiscernible] from question our is next going to

Unknown Analyst

I had FSGS. one on

data landscape updates some cuts more endpoint if defining position the you're secondly, anti-B-cell wondering, mechanisms. whether the modulators with for Filspari, is given the then the future there's based that there FDA variations some is combo curious on therapy, the a doing of visibility indational exploring? I of were Wondering appropriate around the And with of the of Just a using collaboration believe just optimal slope B-cell some point. study lot on endpoints the on whether at that FSGS, recent be Filspari may obviously, top been in on may to mechanisms, regard the the there's any of IgAN, newer work that some in benefit of from a eGFR broader you

Eric Dube

Great. Thank will over I you for those the to turn questions. And Jula, you.

Jula Inrig

thanks. So

sets, proteinuria-based that with really the trial, FSGS, to an we're And Filspari IgA Parasol they've most available pathways time with the of of cascade second which new they'll announced they're is putting contributing as decision few different to think partnership placed. and injury patient we of be [indiscernible], it's would on it exciting and do top of with data Filspari redefine the years I your with the their this outside our become far aligned should which the As in targets of FDA. injury looking because a protects under into to nephropathy against ASN I for for question hopefully, be endpoints. target how And KOLs. add patients regards this reengage therapies And to going clinical but context There's endpoints analysis all group, where of to for years recently context. to to external organization FSGS. We response then following And being website additional data newer plan processes is an standard agents few is be final plays historical called care the academics But and enable these what help we're it's at around regulatory Parasol. FDA, parts and the deposition are a some are of really endpoints that. to should the GDI public, what is targeting that's those the some kidney treatment. from and agents and really, away foundational they're a and line?. And a the further our immunomodulating used alternative the role FDA the that With a in on damage. foundational our the and continuing trial really it's And a it's really

upstream top standard part care. the of You in a agent of add and those target X additive. many other another with things being allowed trials now And superiority of and as need trial of on care It's could point, that is foundational treatment. targets studying damage new ARBs of that pathways, over to kidney you potentially important they're of to realize the your to that's foundational standard because Filspari agent ACEs every [indiscernible]

will over them from and about we So combination they out data get used these being together. the time trials as read

Eric Dube

team, generating interested the are certainly that combination SGLTX. very we of looking and have of Jule's ongoing we in data. where And Filspari additional proud combination at plus studies do X I'm

increase of think we have yet combination that So that, the therapies are initiated, would studies expect actually as other approved. few some potentially been that I could

Operator

Wainwright. Our to from next come question is from going Arce Ed H.C.

Antonio Arce

A couple of quick questions for me.

X get And can question a the of would to guidelines what expect before [indiscernible] length would Filspari they or for physicians if wondering the -- upcoming year. what discuss X so for some have more and especially have next moderate What you on experience sometime the the with impact this later sort I year, been subjectively, those at Firstly, analysis and with as SGLTX look period for year, of regards as I last the expect and But to months drug. as the the impact treating you confirm guess X those more into is combo. mentioned bit. that Peter. review approval, trials points ongoing the inflection just if data that the could roll this sNDA from quarter you quarter-over-quarter that you growth would later a this in or then secondly, I'm of far wondering rates PSS

Eric Dube

Bill, take the you question. you question can PSF take and then Thanks the don't outlook regulatory for Peter, the question. why

William Rote

Yes.

We how review, that take expect end that year. of a would a this X-month to the If review, it be with predecessor have agency consistent In have a we priority would review went standard until it for the be were so of QX a will the case, decision. just recently out that you'd before us. sNDA treated

in for question. case, this rest either to your we Peter So decision have over pass a of year. I'll the

Peter Heerma

Yes. Thanks for that question.

to evolving with as label? And regards I elements you patient to I X with think [indiscernible] to in point landscape, mean really would broader for as that like guidelines that the the potential well what the the there would is regards a for to platforms future.

with I I think urgency protenuria, is as not [ there's treat emphasis to go with of to have need year, better proteinuria the you end-stage is level proteinuria last the a from the RADAR published further shows change to to disease level data or data of it of in actually urgency that X had compared lower kidney that still where [indiscernible] it's X.X, ] core those the has patients X.X. to average to a even elements. One and U.K., be. patients And got think of progress doubled the

tenfold. much for treatment think I Filspari the recall, is I foundation kind replace months to it X after and and as life physicians to was after the this actually that efficacy and So more and that threefold, data mean, of it then [indiscernible] was [indiscernible] currently X [indiscernible], further just protenuriabenefit those the that had in years, in but amplifies guidelines with a change urgency change reinforcement

aspect. an think is that I So important

think, to I the one urgency So change, is aspect.

the XX,XXX, a up population have the we patient broadening that we to the there allows Filspari at is lower XX,XXX think and launch, addressable highlighted patients [indiscernible] broader earlier to between have highlights is go The it with And target. of as what population. expect well of we really label a for think XX,XXX an for second We patient we for is said proteinuria guidelines Filspari. one as further to addressable to

regards to patient patient potentially want X what Filspari. and core with landscape addressable the I aspects the think the highlight I those population evolving it to are and for for means [indiscernible]

Eric Dube

to Peter. you, anything like add? Thank is Jula, you'd that there

Jula Inrig

Yes. Thanks.

SGLTX we highlighted be future. combination, And Peter diagnose therapy patients and earlier a think is going have earlier. know nicely the and I couple to that inflection in points then treat to the KDIGO them of combination important we

earlier [indiscernible] a point we it course. they we utilized proteinuria no trial point that's I change RAS things. eGFR that over thing We'll the to XX. to continuing. ASN, and think of their see as have data data reduction complete and we some most disease I has earlier But in that have So trial on are X the in patients additional the earlier, regards out is where patients the That treating called been getting after that shows over We additional an third into we XX% years. as treatment, Filspari far and get Spartan, want an remission diagnosed of naive. with those early the But presented think first at in

Eric Dube

launch goal and that are right Filspari, and to from be believe Maybe Thank for moment, as the a consistent strongly step one for who time. full very right reduction we put that positions we this we also expand we Yes. towards thing the of get right that ourselves you, [indiscernible] patients Jula. that I if guidelines could place continue We clinical rapid we clinical and a physicians just potentially physicians and to make have And be know think It that their experience dynamism nephropathy, a is of really hearing the And and end lower just at label to really the in and Peter with Filspari. the the place the our treatment think all very for with getting right target in a us of in assume we on about broader to increase with be will patients proteinuria. and at the that if time. you you future the are IgA there's experience, is believe take at sure potential approval if a new that we growth. back able physicians XXXX we'll from the

Operator

And from to Chico Laura next Wedbush going question come from is our Securities.

Laura Chico

see about the I there to able to kind Eric, along? going gears and patient I And And and comments related of HCU. you we as one over on disclose with disease plan with respect that, expansion this, an patient if you your shift but to time. orphan populations missed do number keep would you're kind apologize the of like patient pegtibatinase. identified to ask I'd be of a phenomena registry to

Eric Dube

or know we'll others can't able commit at as team but to potential the our Great do source do be around looking today, community. question to the to patient an information identification. Laura. It's and to I plan be we of certainly do And a a that sharing incredibly for we We have question, really that, looking it something we registry, is information great think we Yes, us continue well. it's -- that for continue absolutely that's have done, important something that. at.

Operator

call. And hand session ahead. question-and-answer today's I'll go Anne. the call this Please the conference will conclude over of back to

Unknown Executive

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

Operator

And this concludes for our you your call. participation. Thank

now You may disconnect.

Travere Therapeutics (TVTX) 15 Feb 242023 Q4 Earnings call transcript