Earnings call transcript Q4 2022

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Operator

Good day, and welcome to the Travere Therapeutics Fourth Quarter and Full Year 2022 Financial Results and Corporate Update. Today's conference call is being recorded. At this time, I would like to turn the conference call over to the Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi. Thank you.

Naomi Eichenbaum

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

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

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

well the press on SEC. forward-looking today and XX-K disclaimers issued with earlier our XX-Q as statement Risk see Forms the the the release Please company's Factors in section as

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

call, we the and XX, covering reconciliation and the issued release results the the among things, results. certain will financial again, other quarter Please December non-GAAP differences results GAAP a financial financial XXXX, of the year for ended financial most certain non-GAAP press company's be for including between results. today's to During direct refer comparable earlier the today

can travere.com. website at the on release our You access press

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

Eric Dube

the we deliver our reach prepared therapies and on in medicines. mission develop pipeline, organization advanced leader the achievements year, disease. that living is last This continue was XXXX people position for rare Thank to many disease that our rare approved patients have currently . of launch as afternoon, community. you, our Naomi, everyone. good identify, our and our year and further to in with Throughout rely strengthened a life-changing a to founded

of rapid FILSPARI adults IgA IgA, is disease Perhaps culminated most reduction compared medicine of importantly, nonimmunosuppressive a for reduction demonstrated in which work nephropathy only proteinuria our the primary at a has for recent accelerated threefold and standard or risk approved IgAN, progression. FILSPARI to of approval first the care proteinuria in superior of the irbesartan. with

you call, we high of aspirations As who our risk believe approval FILSPARI option will patients at IgAN about for treatment as talk heard us the become are recent on it foundational we for progression. rapid have

team the market the deep strategy we and that to goal. the profile, the Importantly, have achieve product insights,

we patients able If U.S. are the positively many to new successful, with we be this medicine. will important impact in

will we're We only with the are detail into bit Peter by few the more U.S., and engagement go the payers encouraged patients and into launch a in in shortly. a days but physicians, initial

We XXXX. more come milestones still have fighting to with FILSPARI in

launch from the of Beyond in in the IgAN review for application Europe. in are for in U.S., the XXXX we a the marketing trajectory sparsentan of second half the authorization treatment setting conditional EMA the anticipating decision

our to with the And look partner, data also CSL we the closely review We work forward Vifor ongoing will the continue to study. from throughout PROTECT X-year process.

supported from the of accelerated last study results As the week. a interim reminder, FILSPARI approval the

quarter anticipation is with fourth we of year. As the for this data of such, are waiting which X-year set, planned the

of able of utilize we'll preliminary after indicative treatment X be analysis the Based XXXX. upon the the were a a available treatment the that interim EGFR results, time years and potentially to in effect clinically meaningful interim data submission data for traditional those of at we approval believe

a a regulatory are we sNDA year with to submission, the end of ongoing would X-year Vifor of to half DUPLEX submitting second application in FSGS anticipate second this If year. for DUPLEX European by an results being top together variation the data would also have CSL position the target of endpoint line Additionally, this in and the subsequent in of quarter our submit year. CMA an during from from sparsentan, we in expect FSGS study to from the supportive

us This to would represent help disease. with kidney to of leading of an the patients one failure incredible opportunity for causes due FSGS, glomerular

as sparsentan, from Beyond this a anticipate additional plans homocystinuria, for our we Phase the III program potential advance as continue HCU. after we ongoing provide complete program in our to novel COMPOSE Later to engagements. data or being we classical position study devatinase year, well regulatory for

ultimately XXXX first was targeting to perseverance our from accomplishments diseases. of a remarkable rare pipeline organization's and for proud our therapies our I'm approval us and get Travere, year of

We XXXX making, life-changing has and off to we our and in been therapies a people mission have delivering the milestone continue more much that working years with living of have towards started with come disease. key rare to

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

Jula Inrig

Thank Eric, good everyone. you, and afternoon,

exciting patients of This kidney an set the the for stage many for and approval and pleased XXXX to could bare families FILSPARI. year We stated, IgAN. be Eric impacted and has As the in created the momentum community not Travere, community IgAN to accelerated recent be exciting by milestone more developments come. promises with the

worldwide. of It to that uncontrolled. a is as kidney it often most cause failure. a major important is primary IgAN It is is remember result, prevalent the And glomerulonephritis

a face XX and with anxiety failure up In approximately life. IgAN challenges with to the of Along depression with faced high-risk years. people median kidney and everyday work debilitating and keeping pain living way, fatigue, time fact, many

reducing IgAN. Steroids in the at are oral that's tolerability reserved or IgAN profile. challenging XX% for than and new generally FILSPARI inhibitors, limiting Right their can that also safety utilized receptor available, medication SGLTX more of adequately Patients and to ACE angiotensin approved once-daily of more be is of less proteinuria. nephrologists proteinuria now, which are because patients effective but are concern reduce reduction effects. inhibitors only severe non-immunosuppressive for for the proteinuria treatments and blockers, seeking desperately less to and respond patients don't which their effectively limited are side with

its antagonist, of pathways endothelin to angiotensin receptor X causal first critical the kind, IgAN targets dual progression. disease FILSPARI As

while greater in irbesartan. tolerable proteinuria rapid reduction compared PROTECT similar we consistent to and profile the sustained In to showing safety study, observed a Xx and a

are demonstrated FILSPARI clinical the the and for accelerated a which study strongest of received, in data of are highlights to proud the we label We date. head-to-head thankful approval FDA's IgAN have Phase in III

labs, medical understand current A a tool you liver monitoring as single both review blood with draw will seamless at pregnancy the process. can and that the visits to worth we that encourage integrating and I REMS and is and obtained entire further filspari.com serve effective of in physicians typically monitoring undergo to the label be into their monthly REMS their for safety REMS an clinical noting profile expect be patients performance, course high-risk point monitoring patients. the

line this this disease risk we new solidify top the patients as that from these benefit Overall, expecting If FILSPARI's clinically progression portion confirmatory will study. and beginning provide of FILSPARI's believe just to data will FILSPARI meaningful year, for treatment, nephrologists X the a data a PROTECT with at potential confidence of label treatment this potential. on realizing rapid needed the their this IgAN standard. further for demonstrate the is years prescribe after we're of Later eGFR

long-term a with and for reflect expectation total submit benefits enable would to studied would the approval traditional the us and of a this of the PROTECT that representative be label Achieving FILSPARI. of more

from pleased study get tiling DUPLEX the lock. sparsentan is to we're we're database and plan, Beyond results IgAN, the DUPLEX to in nearing the continued of progressing study to conduct The according FSGS. and with efforts

options. FSGS manner, a expect in the the submit for we variation could living to are Europe. X-year be with progression a for facing would FSGS as and and IgAN sparsentan look fewer even to FILSPARI to effective for paramount sNDA favorable kidney We if indication data for our progresses people CMA be an label. If also submit application, an to safe an approved and added failure faster to in to This many gain treatment

Beyond sparsentan, classical continue we in pegtibatinase our advance homocystinuria. to program

quarter, the Phase final we activities in cohort COMPOSE completed and During sixth enrollment the study. the of ongoing I/II fourth

total in resulted XX demonstrated X.X In twice resulting dose week weeks pegtibatinase of of with reminder, treatment in through kilogram a total in clinically per treatment. homocystine sustained weekly dose-dependent XXX from treatment X approximately and cohort, of homocystine the a micromoles rapid meaningful maintenance total of threshold XX reductions XX%, reductions of week pegtibatinase in during COMPOSE. below As homocystine milligrams in

second this for remain and Our regulators with is be a could initiating additional and for in data later will a III study cohort also this utilized in dose completing We our program COMPOSE half helpful Phase and be sixth from on of pivotal on year. if These evaluating that track additional engagement setting higher potentially approved. lyophilized year. the data if effective potential the commercial a formulation

designation Track Fast received we development programs, in our development the XXXX. program on Finally, for Chenodal

the the is cerebrotendinous treatment of currently recall, of but has you may for recognized many of gallstones, for radiolucent CTX as care xanthomatosis standard it many or years. As for Chenodal approved been

Our set RESTORE is identification to of the needed aid living option. an is significantly the access have label this designed CTX what us to will we provide ongoing with treatment to data to true help and Phase amended sNDA a that a the believe could people patient study III to believe submit earlier allow use product. gain reflect greatly We

relatively if that patients live can go treated early, normal on identified oftentimes, know a and CTX We to is life.

submit III Phase an this year if have the supportive. to data to data expect study sNDA We and subsequently the are in-house from

including color turn With the the on FILSPARI the that, launch. call over Peter? Peter for commercial additional I'll to update,

Peter Heerma

been us. Thank you, Jula. This has exciting for week an already

and built As execution Friday, be over infrastructure, I years. a has and delivered our proven further launch mentioned last we the experience call with commercial FILSPARI upon the with team to We on now FILSPARI. have specific dedicated launch X past our strengthened successful consistent which capabilities our expertise results

this urgency, team X consistent been pleased total Even of our executing the nice and nephrologists to FILSPARI that a was that approval well team field, for to care out to public Friday as Within the though ready both payers. operational. FILSPARI, well engaging customers, into afternoon. with their has Monday get holiday, sense the teams and our that materials a mentioned framing finalized REMS our was to were of were field excited execute were and in websites since day, with the report very label finish I and commercial I'm as

being approval. the written you FILSPARI more and planning initial to momentum these build. on To bit hours X anticipate date led FILSPARI prescription of of our All extensive this We within commercialization. to context to a continue efforts positive first business provide execution

nephrologists experienced Our team than with is professionals in engaging of conversations payers. productive and more field commercial seasoned XX

the care adult of population profile patients challenges with of address burden of progressing. on Focusing potentially risk and the IgAN. at set how could rapid addressable in FILSPARI's the current disease The shortcomings of

simplifying expectations, our expressed more initial from patients efficacious use waiting and interest approval, like long-term that need Through in patients immunosuppressive their treating who they rapid that is for community progression. consistently of allow receptivity in with FILSPARI. nephrology tolerability product have IgAN treatment nephrologists The a have risk options at of the agents. issues the are been line for Without that

need. to consistent nephrologists the well of upon under resulting efficacy XX,XXX past know endothelin. relative angiotensin common robust roughly actin the blocking, to for the stimulate we increased FILSPARI over barrier Based FILSPARI efficacy has readout missing antagonizing that superior Integral damage indication. other kidney, are positioned on has foundational is for fill to to believe interim with We levels. that XX,XXX a become to current endothelin component what that each potential going the adds the novel FILSPARI endothelin in motive years, tandem built in and been convinced the and and proteinuria option has belief It addressable and we as it the trial. and the observed And the filtration amplify blocks treatment data, IgAN allowed act the and XX on the in with but FILSPARI routine, patients from safety to the

the goal is to It the evolving paradigm. FILSPARI, our treatment therapy for within cornerstone make IgAN these patients

how FILSPARI on efficacy help a the have data the understanding from recent nephrologists on patients. in nephrology sought approval the educate may focus to in to progressing outlined mechanism FILSPARI is mentioned call them driven. in the IgAN have launch we rare we know profile, label. that rapidly that I and largely and product safety filings both initial nephrologists and our their Therefore, -- that as Lastly, give a

we that the process a is dynamic be coverage. pay launch navigating to getting Another of will

to XXX conversations off conducted now. those also Prior Here, I starts. scientific already we approval, believe building engagement to are have a preapproval million and payers with initial we covering solid lives are we upon over

reinforced have to that IgAN interacted for and these referenced exclusive already national have aware appreciate we with relation the week, physicians. of for payers and the reduction an we payers in importance are progression. disease that plan of proteinuria interactions well This experience also several patients generally virtual and

care help is support total copay-assistance typically patients. trade established and enrollments, which by patients also have to for physicians reimbursement the and We participation a REMS education, offering process procedure. simple personalized with in their

physicians to also for that process, Then review is to prescribe and prescriber of REMS their established the nephrologist prepared the will this with During monitoring understanding emphasizing currently guide label. seamlessly be worth integrate they our will It ignore REMS FILSPARI. used the other therapies. processes

FILSPARI started patients most. standpoint, well on be execution our In summary, to to specialty on FILSPARI shipped bring and need remain to we are positioned to pharmacies for powerful we From next it track a logistical who has deliver our purpose, week. our according plan,

of our with portfolio organization. product our of continue performance XXXX. execution in-line quarter I very of the to the commercial in to fourth be the Turning pleased

continue and For the patients. of demand we cystinuria Thiola, solid supported as we see further to have treatment identification

testament This the of space. rare a our kidney capabilities organizations is established basing and to in our inspired operating way

evolving are performance competitive landscape. We within the with meaningful pleased Thiola the

materialize talked about historically, sales net the could affect seeing generic impact of further we have we expected Thiola of are that dynamics year. and this As we this

bile Our to reputation a of has have continued These to in deliver the key continued team fourth to dedication been growth. quarter. portfolio in long-standing educating performance hepatologists. growth and pediatric efforts The acid

to conditions build of capability prepare expertise is as and team's fact future the CTX help we upon as a a for foundation patient physicians potential program. provides we Our solid to ultra-rare indication progress for developed This identification is fundamental. in these even

while growth the bile performance. Thiola we in expect portfolio that In return sales, XXXX, launch year-over-year our we we to expected expect of in by product to anticipate the will be growth this net FILSPARI acid offset

FILSPARI anticipate in prescribers in we that adoption and initial anticipate recent gain FILSPARI's of reduction as trial, same experiences once end proteinuria with their gain the PROTECT reminder, observed the the in line payer year. be And first we will to a the meaningful months. As towards X performance we benchmarks X observed and accelerated coverage consistent the

growth our end positioned XXXX. the ongoing of our year, by of, this the are Beyond we demonstrated which well execute, to performance first This, in with commercial for higher FILSPARI, ability is as with exemplified robust together we timing before us make gives meaningful traditional to our our the therapies treatment potentially will strategic may patients. approved in progressing succeed and for FILSPARI foundational FILSPARI objective of profile advantage be IgAN confidence that rapidly

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

Christopher Cline

Thank you, afternoon, Peter, and good everyone.

commercial execution the position. ended of the and we in throughout XXXX the priorities strong focus With business, key financial continued our organization on a our

million product $XX.X $XX.X For sales of in XXXX, quarter the for were compared same the net fourth to XXXX. million period

sales to in by the acid for products. million XXXX, net for For sales largely compared in is the in were year difference million to bile increase $XXX.X partially attributable same full the period product $XXX.X offset sales, an a The XXXX. Thiola decrease company's

million and XXXX. XXXX for same to quarter $XX.X expenses the for $XX.X were compared period in development the million Research of fourth

the the For to manufacturing XXXX. compared period expenses were advancement increased the company's clinical of clinical $XXX.X including XXXX, headcount. million is R&D to largely same for the full attributable expenses, in trial percent $XXX.X The and programs, pegtibatinase and difference year million continued

million of quarter $XX.X Selling, XXXX expenses the XXXX. $XX.X same for for On administrative XXXX $X.X XXXX. compared the same were period and of million the in period the in for million fourth compared R&D million a for fourth quarter was basis, non-GAAP expenses $XX.X adjusted to to general

for to $XXX.X commercial week. difference the in is on full team the expenses FILSPARI, were full for board sales launch ready million the XXXX. period including having same this attributable SG&A compared the For largely to to preparations million and The $XXX.X year XXXX, launch

$X.X expense is of the period. $X.X adjusted the income for fourth same largely increased was the On a XXXX quarter period same in for in basis, expenses XXXX. million expense SG&A non-GAAP income in compared XXXX the The quarter for during Total million net compared total the net to million interest were other $XX.X $XX.X lower of and difference fourth attributable XXXX. period to million of to interest other

of or $X.XX or XXXX. of for to $X.XX Net quarter share in loss compared XXXX period basic share basic $XX.X million a fourth the loss $XX.X same per million net for was per the

year fourth for share million full was XXXX or quarter net to per period the or same of net same for $X.XX loss loss $XXX.X XXXX, $X.XX $XX.X For in loss the million to million was compared $XX.X a XXXX. adjusted period On $XXX.X the in per net for XXXX. million the basic share compared non-GAAP basic of basis, a

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

to continue we variable advance As our operating our that we to quarter-to-quarter will ahead, increase the programs. year look be expenses anticipate may as and we

expanded primarily our and SG&A, by success. FILSPARI position a driven full For this for is the place investments sales having in year associated of to launch team

it R&D, and driven the to work inhibitors of evaluate a sparsentan prepared potential with as as DUPLEX program, the building PROTECT combination studies to is supply. continuation For well in for both and pivotal of by primarily and our including percent

Accordingly, our potential This milestone operations well investing for support potentially for that IgA programs. into Thiola, pegtibatinase to balance and can sheet payments related as in into both launches we further XXXX. competitive we well achievements anticipate as for FSGS, account to the dynamics advancing takes manage our

with position number our XXXX. a execution we entered milestones financial and to the a continued in to Importantly, launch pipeline the exciting advancement of this of support year strong new period key of

his back comments. Eric to for over it turn Eric? now I'll closing

Eric Dube

and work the and the Travere of value physicians, . the these those successful led of unmet want payers, the FILSPARI. Chris. dedication to kidney team early their rare gratitude in for the demonstrates express you, community. The moment, Thank my has the strong to to hard days, FILSPARI the need their that families patients, and launch the I reception even us of in addressing patients rare community, in disease by

of of this on are have We pipeline. In to the come, in advancement quarter. and still to the our year a PROTECT the in in improving including patients fourth are second X-year this to the from data in lives number exciting the half focused for of do and we potential committed regard, IgAN milestones so trial of sparsentan the the IgAN Europe of approval

study this X-year DUPLEX for to the for line share program quarter We new expect And from lead this III year the which could a year, prepare as of be we more the of an in also Phase important to anticipate second top able in FSGS sparsentan data we potential in finally, novel sparsentan. endpoints pegtibatinase our indication on to program.

of an years has up for hard XXXX. work bright incredibly Our set us

confident will for deliver am disease rare I our the talented patients our results and for strong community. team

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

Naomi Eichenbaum

for can Thanks, please Eric. open Q&A? ahead lines you Rachel, the and go

Operator

Instructions]. [Operator

will question line America. take of our of We first the Bank with Greg from Harrison

Gregory Harrison

start could walk from to the the a for enrolling in REMS? script, through just REMS off, then Maybe the me testing program process patient's maintenance monthly the getting perspective you and of the

Eric Dube

Jula, the prescription Yes, And maybe these turn question. treated. what within patients can can how Greg, we'll process fits how is FILSPARI. walk for receiving through for and walk Peter, the to you this through and you first you are

Jula Inrig

for question. the Thanks, Certainly. Greg,

in particularly So their algorithm. more risk change are a if nephrologists have realize patients going for that their treatment who frequently, are and to progression at you see

may every labs. they month see So them with

nephrologist, and sign see to of significant the going going decline proteinuria go so their the well progression, overall as they're eGFR REMS. up patient going is discuss as their for And to nephrologist to their as is having risk

for the is for and REMS patient. signing details reading contact proportion both significant the to the signing to filling signing statement well guide from up and out a means as going be then the that patient your reading label, a the pharmacy simple says and That's appropriately. you're means the then prescriber monitor physician this perspective your educated. They of need that process REMS And up as relatively

they're they're contact give means a process. couple specialty their to a patient. process. I'll is the going detail their been That's specialty be a of the read then informed they're prescriber therapy follow benefit pharmacy. they've the X state follow going patient, details going what going that process. And get label, just additional to for their that then to this the read the month pharmacy the every going process same pharmacies, we to They about that have guide for a get give and is then And to go and overall informed just they're labs and through a the to that details, add and and through risk similar contact test they're that then

Peter Heerma

Yes, Jula what let for me thanks, Greg, build that and on question. said

more little a care mechanistics the on details total you the of services. giving Before patient

think first that's need reason high the good to we approval have I it's why And these the in accelerated realize move. the for patients.

have late within remarks. to younger early XXs. the realize mentioned patient a and this is often or as teens previous patients kidney XX progress years, in the diagnosed population to and it's We in those of failure Hard Jula

those of So midst of a stations the lot lives. that will end . productive up their in dialysis that in means

talk nephrologists we these treatment REMS response the and options days, day we alternative X for and have have promoting it's early early patients that the so still option. confirmed have and don't this as of early seen FILSPARI, they is from today but responses When about far, they

of for once appreciate simple their have safety nephrologists that patients. procedure the REMS FILSPARI the clinical FILSPARI, profile to they enrollment back understand value and focus the and they So may of efficacy the

both Total I process with talked convenient be think will physicians that within the we pharmacists pharma I what doing, the services make like this as provide and about patients. especially the the but you as possible also Care, specialty will have specialty well as already as for physician to system say

Gregory Harrison

community has helpful. and could us how treated influenced you this nephrologists many launch how really by your patients are remind then And That's Great. IgAN strategy?

Peter Heerma

for being to potential. why on X,XXX we going the the cover week majority patients are well. about have XX% nephrologists will plans that I treated be call patient as of that far consistently in we community those about the So by last of the mentioned That's And nephrologists.

Operator

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

Maurice Raycroft

recent When the intent and at in asked you months market tested of year did research. market X about last research your key aspects prescribe wondering the of year launch, if the to or in X most I'm label end you of

Eric Dube

take would Thanks, Peter, like to you Maury for that that? great question.

Peter Heerma

Maury, absolutely. question. thanks, that And for Yes,

have monitoring we market that the research was liver external REMS that intent not syndicated for done So at that, consistent to prescribe the to actually prescribe we did profile remain to XX%. result me latest research, after and It And again, a by surprising intent intent we quite announced the reserve. market label. just in did to came protect change this And like -- I the just saw by consolidated the of of XX%. example, week

consistent first So prescription in the X XX% the intent very prescribe around about months. in at and first year to XX%

So they change. didn't meaningfully really

Maurice Raycroft

message of And around you highlighted to will the challenging will And eGFR you efforts. learning be? around how plans doctors? it. Got Peter, where curves doctor some the you Can education talk about most

Peter Heerma

excitement early but it's FILSPARI. make we as from mean so field I day the our there I'm far, I -- hearing promise great absolutely. is see it's Yes, what for of days, for is reps, what

text In in the games who never has years. level field nephrologists. fact, he has for of among that excitement one XX of Saying yesterday I seen this from been saying our got a

plan. monthly and their how basis monitor to certain learn change of the how is of physicians they there also and on think profile often treatment a they and FILSPARI the level excitement are is a of disease I about market measuring proteinuria progression So that

learn those eGFR trial So not an come yet many has FILSPARI about it's profile to the ongoing They understand up conversations. more excited of and time. very over in conversation the

Operator

comes the Schwartz question next of Joseph Securities. SVB line from with Our

Joseph Schwartz

nephropathy IgA a then question I have and on FSGS.

the to centers? any rate other uptake be at amongst that if physician community particular So academics demographics patients do segments, differ, expect nephrology FILSPARI versus later you those earlier treated there are you or to all, beyond adopters? expect how of And

Eric Dube

very the to great much Peter, question. that for Joe, I'll you. over pass thank you

Peter Heerma

just that Joe, research I of very referencing. this was part the Yes, also was market timely question, because

nephrology. Very intended yesterday. across that FILSPARI saw the utilization, interesting, is in I is for as basically So the community utilization academic it nephrologists similar

So among intent is materializes categories. will we the similar how over time, quite X that but prescribe to specialty see those

Eric Dube

just for adopted fantastic I of who add, are and understand those to physicians segments we plans, behavior that X,XXX if those not sure could recent is launch our make we team are job to quickly. in one Maybe Peter. reflecting has also Joe, just through early done Thanks, that the a Peter's innovation sort their late of really helping more versus the that adopters targeting have The but recognize things adopters.

so team focusing of part on we And is first in to very clinicians many very efforts that the sure see other our we're -- adopters, those much our similar early making that launch. would as launches.

renal number not I So versus community, a and, just recent I patients think but such also it's academic rare it's of launches. about as say, behavior as of adoption

Peter Heerma

we consistently that nephrologists. on calling X,XXX may build that, be Eric, just about I will If mentioned I

adopters. One So X,XXX. we to based those and give how maybe on influence those And based different community. new to get segmentation the targeting is product on did. X early assessment It's patient more a we was volume. X that context little particular was behavior, really to One utilization got on in you to nephrology to third really the based on on in

broad very a prescription have process population. in clear patient segment we So that to we that way to get most valuable target to those as see and physicians the

Joseph Schwartz

order meaningful the Very the then the terms clinically is What eGFR what's quarter, look? between from be be in there approval? FSGS thinking interesting. of for need How next for in to to able And bar guidance does have you achieve to what do approval. the any you that specific file for we for should And difference? success about bar says the and FDA overlap how that data

Eric Dube

and question. success the Sure. effect. I'll and perspective. Jula clinical turn you Bill, a first Thank see expectations And we share the insights where the would relevance to regulatory of then you, can EGFR treatment from you Joe, for on

Jula Inrig

Certainly. Thanks for the question.

you I the look mean, on inhibitor slope, of treatment difference to range translate in X them, X should and if a meaningful clinically in historically looking per that important slope proteinuria at eGFR and showing minute think the at in other at ml to I difference. clicked protection saw data . it's have trials is you FSGS significant note look long-term in a effect the if eGFR. from kidney into difference a in anywhere most that significant for SDLP that's meaningful X.XX And reduction we

show And on that both the so powered to based seen significant to statistically difference and proteinuria meaningful the we've clinically we date. trial appropriately reduction a

William Rote

Yes.

-- closely it think up regulatory X.XX pretty yes, difference. approved when clinically with about perspective was this lines seen Bill. a more regulatory a it with We've what perspective, meaningful. I I think is is From

is is Jula agency impact small for renal recognizing dialysis, if with in mls or very large consistent the minute in eGFR quite is significant differences on And looking the slopes. replacement that's to treated therapy, to years, a progression time you're So at impact talking has therapy time about. need really with even small per or clearly a what difference for

Operator

We question Lugo will next William take Tim line the Blair. from from the of

Lachlan Hanbury-Brown

Lachlan is for This Tim.

quickly, in give just at that not expect will for the just there we we yes, that there's specialty be in much should dynamics any And be they're new not noticed in months, if pharmacies. maybe wondering you presentation? or on then will what guess, WCN. second late I label I that's presented stocking I breaker X Or Can First, was guess? data at any Chris, a stocking color the presented

Eric Dube

look that? you and Chris, WCN? cover right. take you All Do don't why

Christopher Cline

Sure. Lachlan. for Thanks question, the

a expect weeks the stable stocking. distribution have any be really with shouldn't of really to model, And kind or range when state we to So most. expect of to meaningful it get here, in week X somewhere at we which our you

to at at the there much much be bit, dynamic beginning, of there a through little but stable not really not state. a work will So

Jula Inrig

excited We're to really thanks. And able our at Yes. data to WCN. be present

Next month, to additional you as as safety see our can data. expect data well efficacy

able really will we're data won't eGFR the as with We be we we until present we to that that to But that nephrology complete the not trial. excited community. releasing clinical release the be have to our agreement FDA

Operator

the of Guyn with question will take Piper next from the We line Kim Sandler.

Guyn Kim

about that study think in the DUET eGFR data a you the XXX, eGFR look and slope study readout, at question we extension day there we the on look or use time calculated know FSGS. the was I good curve, When the looking to for you know starting the slope, point you Phase wanted for A is? -- as of III DUPLEX XXX-week at do the when calculate to just And XX, were what estimate. the where at? week slope starting points could DUET,

Eric Dube

designed perhaps the thanks But DUET DUPLEX. we an between have getting expect question also there turn we So I'd long-term parallel I'll I'm what that Sorry, history and I'll the for see we but feel we how a to follow-up of seen the is turn on to a what on that a given and feedback. see in for to for question. you we certainly do active question sparsentan, say little expect natural comparator to you we the have slopes how might didn't trial. that in

Jula Inrig

Yes.

there's minute you'd presented per saw patients our who around year eGFR in eGFR achieve any would at historically, saw expect then preservation less say X XX to provide for I can are to compared those patients would X, year, term in patients in remission, granularity think X, particular, regards of to progression minute, data we X, that what if ASN. more mls I And I FSGS. from than rate with more that the risk preservation with at long-term in like in shows progress like we greater of slope. don't we've primary and long a long-term those received to last me complete than additional per per significant see long-term DUET high patients that. who ml we know kidney at that data

Guyn Kim

the the is a you Just beginning the Do difference look at curve. calculated. at time from just the a of moment but it's the the overall curve of how slope in see XXX slope out week know XXX, weeks? wanted study not I of to the of slope to

Jula Inrig

the And steady at data very great so end. that's You what's way to the do slope. all look at from the about looking beginning, the total

effect the the which end trajectory You will to of the equally effect. curve well after very beginning way look we the all as single of the and to come use data has weeks and both look slope, all minimize end in looks every point at patients for X acute chronic total, all the as to at the wait study more for the hemodynamic data the which

Guyn Kim

account to income a in Great. you That's How royalty FILSPARI And question helpful. will the ligand quick Chris. for for the statement?

Christopher Cline

Thanks to to for sure able financial make exactly view the the we out statements question. paying being XQ, We'll We'll that when and it's clear to you report how be as we're now. updating so finalizing guys we're that. that that

Operator

line Bayko the ISI. the Evercore Liisa take question next of We'll from with

Liisa Bayko

guess you think what the confidence? I of of But that can my for Maybe have of explain kind confident. confidence highly but Are confident, of so outcome the level just good hopeful upcoming you not ask just a data? would FSCS level moderate, final answered. questions in most I I been

on how of We're thinking ton Just you're FSGS on a curious days. getting about it. these questions

Eric Dube

we quarter. that way very you is the showing excited largely any there. Jula, the looked the confident that's X-year then significant outcome, had the further over as things statistically Bill, thoughts the the the I'll you on question. out in we've Yes, is eGFR. the remain results. we what remain confident the as conducted, of superiority designed a hoped we like really that that predict at are does it coming out readout and on about trial the was proteinuria certainly, and because good have that we on if maybe, that to certainly data turn And of and to that We conducted being Sure. those way patients look why is of I look retained this robust much Liisa, thank based next would upcoming we for all would say trial to at we've ensure study trial, number that in

Jula Inrig

I'll And support Yes. with clinically separation traditional the say statistically said versus on FDA, in sparsentan with capable and saying, with study importantly, what see they when the we met and continue reduction would I in just irbesartan. significant we approval. can proteinuria was Eric is designed

Eric we And we'll to of have or also what very this to about to show or be able in that accelerated have appropriately. what talk going the to that? to different to under want said, around maybe separation number It's do looking We set add we a you situation. us that achieve -- able Bill treatment the color to be so the confidence at on as Bill, continue effect eGFR. an sNDA our approval. patients powered versus will endpoint And to significant a -- we achieve also out. We study gives be

William Rote

Sure.

partial I both accelerated you're position demonstrated it's that as on study, the they've more a and and approval. traditional safety very efficacy. At deliberately in a for think it when the you somewhat the end that agency for have the approval, set data because approach they of conservatively much

helpful aren't take and them flexible looking their that's we that data. to be at of in is ability in totality asking the that So to regulatory risk more the at point there

both I . think is a that means Friday's approval indication additional an safe already the and now other last approved, efficacious. additional to drug looking FILSPARI element at of we're that's

standpoint in when it under accelerated approval. a So a puts I compared different think from H that an analysis Subpart frame with interim regulatory

Operator

of the with take question Barclays. Gould Carter We'll line from the next

Carter Gould

saving the prioritize launch? data that potentially pulling a the maybe that and data demand assess in guess enough out, in think of significance to data on about and top And Peter that, in going IgAN first the to how for the may coming can think Jula, line eGFR that what much data going guess FSGS we have positive meeting? you data you nephrologists line to when extent Or is the top alongside we that guess, be clinical some from do -- I I for FSGS first you that? medical data half forward through Are release? are that read XQ. going potentially is to to I see -- in

Eric Dube

for thinking Carter, take readthrough? then your team is why can add Jula, top what line, you the And question. potential Peter, don't any the thoughts. the thanks and you

Jula Inrig

a mean, a great completed. I it's Well, we'll have question. trial that's

not with we're keeping limited regards So data. to

whether additional we an our meeting, you soon, pretty give want data, total -- all a a have to be the able all trial. high we but of presentation but we it's the the give balance that However, publication important at have to confidence about data, to . very decision release tiered going to you at because probably and to eGFR do the enough and results we're least make will

in patient versus see I read-through, in and to disease is magnitude with XX% one With it it's disease and work where kidney and SGLTX the or nephrologists same failure, the to board inhibitor across through regards the dialysis underlying transplant. drug a And things. other, eGFR the regards treatment may studied you Each with the even other necessarily regards to the reasons, quite should for point disease, don't though heterogeneity, endpoint different. whether to data, other the the the of number would think and the not the the we decline different X population might of effect

the want make that? there. other wouldn't one what we Peter, or depending you to that carried I So or effect necessarily going do through other of from say comments see be on to around treatment there's the the magnitude

Peter Heerma

No.

that really continuously have it's been and you is make Let we with about The about hasn't it, I FILSPARI. patient built Carter, continuous different. think what only to quite way think the for those excited stream physician. And I me think they that are said, profiles the excitement talk I data

data So almost a year. it that new . is coming the continuing new -- launch it's aspect, in in like with and approvals next

Operator

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

Unidentified Analyst

be approvals? the they do prescribe do practicing Is to FDA could for And compared in academic monitoring then This is for to separately, label of fair the say effects that past ePCR greater it you any Adam in would touring share conduct information to EU in class better equipped preserves a on Mohit. that nephrology to centers? due

Eric Dube

Are UPC the I and compared have to the on I just the we of sure label Let label. you me question make first our want asking detail data that that around to clarify the level answer right question. and others?

Unidentified Analyst

U.S. patients of some No, ranges whether like? our I'm safety that past on specificity as ultimately, looked the in you treat what be in label that ultimately same put geography PCR what of the for you the would to you Europe potentially when it relative as the labels the heavier in have well approval detail asking could have the get

Eric Dube

that given turn you we're maybe Okay. you. specifics mean, on European on we labeling maybe that thoughts still the across how speak Bill, can I be we to may that won't label, the regions. process. Got certainly, it. Bill, But able some vary to in give can to

William Rote

EMA. review And data do the NDA, but question. they same how set. the because data you're they're with the right, for with the important data, different for looking they process FDA in differences speculative Eric. we're a thanks how in realize the It's No, It's at Yes. answer for contain have X data. present they filing U.S. treat filing doesn't The to from

REMS example, Europe. as They different in For treat risks a in a fashion. such there thing isn't a

on have indication this anything. it's I in review of early we really at definitive don't be great think too the any the it's differences -- point agencies, but between to

in the forward So look to you that we that, updating on future.

Eric Dube

and on out? Europe any . -- being in want Peter, that centers to take based do might play difference any academic you patients on predominantly in the how thoughts seen more practice in

Peter Heerma

Europe be had European. as to experience the Having in

that I it depends think country. by generally I mean country it's right.

think, it's service generally, Europe. in more I think I

you to think see I nephrologists. higher levels for are GMO patients overall, that being referred

to more depends I think much that is more. very generally right, it

Operator

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

Laura Chico

I inhibitor, sure gram patients on the those over research I'm patients that One an X. clinical of proportion could remain shown our first Jula not about own has a market XX% IgAN SGLTX SGLTX Peter inhibitors. XX%, proteinuria? got the are guess if on I've or receiving on are comment of of what and now And

Eric Dube

that right. question. would to All like take We

Peter Heerma

off. found are to have happy your I we think what well. quite consistent Laura, research signings kick as And to mortgage I'm Yes, that

not versus very excited conveyed the saw important have profound to not FILSPARI. speaking as market think the call the is mention does things well effect I proteinuria-reducing about of one have research, mechanism what I has the on been in mentioned as And SGLTX. earlier well. complementary nephrologist of the we FILSPARI they're but Jula or to as what

complementary they can combination And think approach novel and can about your nonimmunosuppressive profile detail the on Jula about in regards that of that. to I they're excretion with additionally, it, may more speak sodium talk diuretics. excited And more is the in also SGLTX the have now.

Jula Inrig

in with less SGLTXs Yes, their patients, trials than proteinuria, nephrologists on due they're plus The that And of we using the them Probably complementary to proteinuria. other inhibitors together sparsentan the get to I glomerulus, use reducing with combination with interesting interested most you proteinuria SGLTX levels excited agree all data all protecting the would a that. low mechanism in kidney is direct of that of the have talk protective action of exactly, have than they're to that when done feedback is interstitium excretion podocyte, the to know where we significantly the but tubular proteinuria you patients do of magnitude kidney anecdotally, we tubular know they benefit and don't the Mean helps how have gram. SGLTXs, were a the in greater sodium that with enhance that has sparsentan. sparsentan to

you low I look they relatively the, mean at if levels. were

later kind used be to tend in in they So of general. stage

get really them less remission even patient under under gram. think I where X.X to get majority going them to vast So proportion to further, patient patient, high-risk to need and tell lower-risk But than want therapy we the complete a you the we profile where the have are don't get you the the what more than combination that gram really get to profile. them grams can to

Eric Dube

data You . from we next to through that be to able to think, the trials sorry, Laura, just it the I Laura, that in because those a it data that doing. we year have study expect setting have would -- the might see the of would we speaking some be in to clinical Jula, be useful talking worth, are

Jula Inrig

Yes.

add and on information inhibitor, and then I then that that we'll data we year. you've direction the we're and think, eGFR combination Laura, that we'll efficacy we'll have have And have patients on types we and you going to and where patients other next proteinuria inhibitor SGLTX interaction studies, additionally, the opposite got safety SGLTX already do X shows and drug-drug an one, an of are of safely we have And can sparsentan combine. on at and data, have where add . sparsentan. a

Laura Chico

Bristol, then into question mention heard should our Ligand heard payment a flexibility bit I be follow-up runway? looking the on extending that. Could and forward sheet but runway well I you know terms for a certainly We in correctly. cash other considering And the modeling? due believe about talk X more I maybe Chris, of milestone 'XX. milestones any that to inbound they're little I we financial. on the balance you to

Christopher Cline

question, that Yes. Thanks for Laura.

also, some milestones, think and sheet So out there like be in would for those. the coming be in So balance that . have things to advancing, then about when may things will some pegtibatinase coming specifically we I potentially have to approvals like Europe. a net And for the regulatory we right? effect

account And we've is the and commented our in when I flexibility. et cetera. take about at number look there burn, into go potential FSGS but investments generic there, think the erosion overall that things FILSPARI the into We're needed into all of past We're the a and account taking There's appropriately for for launch, we certainly right? and Thiola. cash conservative where approach, estimate positioning for for a IgAN taking further we

we operations a flexibility forward. to to what expect that, as to trying certainly but view give there So in our for guys we're going you some is good use

Operator

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

Alexander Thompson

SGLTX follow-up some this of your FILSPARI with guess, based what of payers, data initial quick generate clinical has launch prior been with year? I next and going on to to on you're conversations top covering a some maybe on at of receptivity the in inhibitors. stage Just the SGLTXs this

Eric Dube

thanks to that? for Alex, great would you take the like Peter, question.

Peter Heerma

Yes.

of particularly. that. It's had to of a from And step for early of are nephropathy, I the like have with not I like nondiabetic for to SGLTX broad away of on both anticipating CKD. took IgA days has thanks quite we what through is payers conversation I a But and rate with think, SGLTX. label that it's have kind diabetic think -- that payers. They Alex, pre-approval comment that. some is

road to map FILSPARI. So be anticipate we a that for don't for reimbursement

Alexander Thompson

with base And commercial of maybe of I the Is that you a guess opportunity? trajectory follow-up sort of over should base of FILSPARI. a that How the expansion few Great. meaningful are uptick sort then the on thinking about potential the quick think business years? of time? how label outside next the potential commercial about business that over we in

Eric Dube

Peter? Sure.

Peter Heerma

there extension as Well, we're we educating particular, the physicians. an certainly in think to the may be I adult about patients reach will excited more that with by have opportunity

the what potential the once of trial. is. upside the given data better we a position may haven't be We see in we guidance any And

Operator

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

Antonio Arce

next Some on point is the I readout a did asked, the excuse been the and have upcoming earlier, already up me. that want eGFS, but eGFR, to made follow on quarter, X-year

after started the weeks, whether first well. mentioned, intervals Just points wondering or what the total of wanted endpoint data to I those throughout I'm period, make X other it sure those primary slope as both correctly, just slope, I include and understood the was you think here interval are the

Eric Dube

Sure. take Jula, would you that? like to

Jula Inrig

Yes.

chronic slope, on total at we the week well from be with looking we'll XXX. and that's end agencies point regulatory looking beginning as have study to So the as at slope agreements the an of and the

Antonio Arce

the And intervals the measurement throughout what period? are

Jula Inrig

you're what labs? we clarify? Are . that should Or you Is get asking? asking when patients

Antonio Arce

Yes.

Jula Inrig

Okay.

there's then So X, the get every X X subsequent beginning I lab and then X months labs and and a at believe patients then it's it's weeks at, thereafter.

Antonio Arce

know urologists do sense today start on switch have basis as launch proportion of a wondering, patients therapy have been discussed their you patients one. routine? monthly last the Maybe a just on current a and visit X has that as this I from before. this FILSPARI, you But for just to the some

Eric Dube

are patient thank you have share would Ed, looked for bit the Peter, these that into visiting. you frequently work? like how to a the certainly We journey patients question. of and

Peter Heerma

thanks question. that Yes, for

be quarterly, actually realize mean when those the at not those program, to are your I is talk basis. Is a patients, think does of obligation to Is and for their do those though patients monthly but is but to quite REMS progressing what the common perspective? will see rapidly a there quite see on They especially patients nephrologists for don't least -- to on you base like Even the patients monthly every monthly REMS need there it by the the lab nephrology their being seen a is question from there physician seen the some those uncommon to an about is good the it's nephrologists heart nephrologists that that not base. for also. see patients patients on by testing month. results, -- those see it

Operator

concludes call will the question-and-answer back session. turn to Naomi This today's I Eichenbaum.

Naomi Eichenbaum

Thank the great XXXX you, results year us joining for a joining. fourth for year you rest everyone, our and on and We progress the quarter updates and ahead Have to financial our of your along look providing forward for day. exciting corporate Thank way. update call. full

Travere Therapeutics (TVTX) 23 Feb 232022 Q4 Earnings call transcript