Earnings call transcript Q2 2023

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Operator

Good day, and welcome to the Travere Therapeutics Second Quarter 2023 Financial Results and Corporate Update Conference Call. 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.

Naomi Eichenbaum

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

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

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

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

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

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

Eric Dube

everyone. made Thank standards corporate disease. good first and people with afternoon XXXX, for pipeline living of we our the rare from you, of of delivering significant Naomi, half our on treatment progress In strategy new innovative medicines

sparsentan. FILSPARI disease adults IgAN reduction first or has by the with of launch the Our FILSPARI the is led risk rapid nephropathy been or only successful at IgA progress in approved nonimmunosuppressive ongoing and proteinuria of for progression. therapy of

in our nephrologists teams addressable interim potential of readout the experience the FILSPARI that study. continue efficacy is profile IgAN to PROTECT from to FILSPARI patients that to believe demonstrated from safety We XX,XXX and help an with the reflective their hear holds field and XX,XXX

with about a representative physician a visiting despite a compelling the a community day story week, grams In field rapid patient shared therapies. two IgAN per risk disease levels with several spent in at with One and above nephrologists. fact, day of last proteinuria struggling young with I woman FILSPARI sales treatment progression

short that The until of has one types FILSPARI level proteinuria them results below noted prescribe with day. physician number gram patients confidence provide After on a FILSPARI, weeks these IgAN. per significantly to their to of a few the greater addressable dropped with

eligible to this field hear We practices. in and represcribing feedback FILSPARI both their FILSPARI standard demand provide use physician encouraged become the with and insights the are These new are confidence more in ultimately potential the for feedback from patients positive and us proactively treatment of IgAN. nephrologists to identifying on a to

in of FILSPARI performance quarter strong we and or growth reflected start launch indicators on executed forms and of are the important success, second XXXX, the broader demand the access, patient payer strategy of observing and PSFs on increasing patient most by two In our driven coverage.

approval readout guidance and top early initial traditional and our we or in the PROTECT study since expect support we delivered potential quarter ahead fact, believe we is label the of quarter. results of number announce from this a expect the that of a IgAN. launch The highest have launch in for we third renal to in the In the to Later benchmarks. line in FILSPARI first amongst PROTECT launch quarter other study the now the potential year, late PSFs broader from rare complete fourth will the

underway in of beyond this Europe in work are Looking around our for Vifor. we we opinion an with end the CSL to Regulatory continue CHMP the anticipate IgAN reviews and year. US, sparsentan from collaborator the

progress we successful parallel, are make start. pipeline on we strong have continued a FILSPARI In of launch programs. believe ensuring also we and is to a that off our priority top other Our to

may in sparsentan of treatment results in DUPLEX and over with that option of from believe positive Phase trends In which effects for sparsentan line we treatment. represent two three to FSGS. study profile reported well-tolerated eGFR FSGS, the a and on continue safety patients an reduction, proteinuria top sparsentan May, important We significant of durable demonstrated years

While statistical on are the the the we of encouraged eGFR study endpoints, did by achieve not totality data. significance

We on a and FSGS an are explore submission that to fall. to meet for discussion provide regulatory sparsentan scheduled potential in with to update in the the FDA expect the future for

Shifting to pegtibatinase.

even growth market from to on years. our a body confident for update opportunity pegtibatinase US, are company meaningful us coming that patients similar a to for With a to approximately X, our Cohort the growing significant patients HCU patients in geographies. and in Europe number additional represents X,XXX of of population and more a Based the number be recent positive accelerate help we HCU of in in the there our research, understand we addressable with

with Importantly, and introduction advancements and therapy year-end. on excited This the addressable by in over are working why innovative efforts an we population we time, see potentially continue XX% is initiating we patient are of study program more this pivotal by to increased towards or our new diagnostics. focusing this the

portfolio Outside recently has the during million, consisting our This announced sales-based additional $XXX importantly expected million agreement $XXX potential for upfront up an organization. payments. to pipeline, benefits balance we will an that most our we for milestone up innovative have and for to into sale close of our bile divestment, acid of in to third our quarter is of entered and product clear strengthen the strategic which sheet future million $XXX meaningfully

FILSPARI successful development the for treatment more believe potential regulatory -- Strategically, with priorities billion-dollar in standards it sparsentan developing HCU. of markets We path to clearly will successfully a the become in even potential. us potential each FSGS, of delivering enable of pursuing the position for pegtibatinase on these and to our treatment IgAN, launch medicines on focus will

the for of our am team's quarter second Overall I proud incredibly performance.

important have advancements priorities with our continue of of and progress made our each pipeline products. innovative We to strategic

the successfully to launch, have quarter FILSPARI our goal We strong the for groundwork enabling full in therapy foundational become of the delivered laying a ultimately of first IgAN.

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

Jula Inrig

like Eric, the afternoon, to the later good I'd half on development to reflecting the exciting everyone. and FILSPARI important this by upon year. first touch Thank updates you, and of come in XXXX for start

nephrology the kidney focus major XX disease the often IgAN the or been presentations. there a Medical Association over team with last IgAN in recent nine Therefore, decade of rare Congress kidney Travere years. developments was ERA meaningful have kidney disease. advancements approximately and Renal European progress field posters significant average of to and showcased where failure needs at While rare in the in are on unmet remains greatest IgAN one patients within the uncontrolled

failure analyses their Renal patient's The patients lifetime, a RaDaR demonstrated XXs. occurring in Diseases National that typically Registry the UK from IgAN face of kidney most will late Rare within or

interim which Importantly, nine our study the confirmed between RaDaR point of XX-week aligned proteinuria study and the months, PROTECT is in preservation subsequent proteinuria to time function. relationship at analysis reductions kidney

kidney The chronic effective a that These with proteinuria reduced treatment and landmark months highlight eGFR of options analysis reduction nine significant, early reduction showed patients IgAN and the that need years. kidney death decline results of preserve XX% RaDaR function. from both by delayed rate at failure proteinuria to X.X to in of capable or time

has one reduction interim supported that failure trends is observed is the early positive rapid XX% approved outcomes At maximally titrated proteinuria from with on irbesartan. the there analysis a such compared and that proteinuria PROTECT accelerated baseline a approval, and nonimmunosuppressive therapy FILSPARI. and only study, we kidney FILSPARI's XX% Currently of demonstrated reduction sustained to which of

kidney on patients of proportions greater as decline that or failure XX% a reached showed from data baseline to eGFR irbesartan Additional FILSPARI death. compared in

Furthermore and into proteinuria, study ERA We of over continued interim demonstrating partial top rapid line readout proportion remission and FILSPARI of FILSPARI. two-year confidence. from presented which durable new to assessment a the accrue PROTECT complete of greater data study effectiveness PROTECT upcoming significantly show achieved on patients the from with the head of period, at the that

difference eGFR in proteinuria demonstrating relationship statistically at Based years. a robust and trial well-supported encouraging precedent at and significant in on treatment on as the sparsentan reduction long-term interim kidney by the of trends benefit is we with meaningful clinically studies the two the magnitude believe reduction to outcomes on is clinical the well-powered from and PROTECT, proteinuria assessment IgAN. to literature show irbesartan compared eGFR This observed between

part of and of analyses review, level NDA we available accelerated eGFR trial significant approval the patients statistically further on a FDA eGFR. on our based Furthermore, calculations provided expectation These our support as power eGFR the for two-year of data. with with supported and interim the conditional IgAN benefit FILSPARI analyses trend

conduct PROTECT very the remain of with pleased the We ongoing study.

traditional These it the late we approval, positioning in for to third and a IgAN. submission highlighted, expected top label Eric broader to our year. data we population the scheduled benefits to are quarter quarter readout reflect therapy of should As support the FILSPARI, anticipate of line for long-term expansion become the or include in early foundational are which fourth now this

Moving team reported results experts, difficulty Since practicing in disease and nephrologists discussions and kidney scientific these the The engaging the support studying of been from in overarching strong heterogeneous FSGS. high theme rationale such as DUPLEX advocacy to a of our disease the patient study, FSGS has FSGS. the we with is the rare unmet actively for organizations. sparsentan need,

FDA forward an fall. our encouragement a with in data justification A provide to the the in the support with update meeting combined the seen we position the broad with analysis be to is from scheduled seek expect in and of trends ongoing positive This DUPLEX meeting regulators. path to a the

a study of also this presenting later are planning a at We DUPLEX the more meeting scientific analysis year. on comprehensive data

Phase six touch pegtibatinase study. from late briefly provided In homocystinuria of of HCU. I'll the sparsentan, the cohort the top beyond classical COMPOSE results we of positive line Moving or treatment upon advancement May, X/X for

Specifically, This a homocysteine of that in total according population achieved consistent diet for important across very mean low-protein typically patient patients highly treatment a the are a in could restrictive support XX.X% benefit is diet. with resulted total to reduction with that levels on liberalization. physicians and pegtibatinase homocysteine

reported pegtibatinase. no we disease-modifying this need first that pegtibatinase enzyme become can for clinical to HCU site-related effectively patients. the significant date the activity were the treatment. Mild managed high believe therapy injection and observed with profile, deficient ultimately replace reactions addressing There concerns in and can conservative have with unmet CBS With emerging been safety

primary look year-end. X the and endpoint of update details study with this on We an Engagements well. X to fall in the with the of use initiating program currently We regulators the align focus for is expectation Phase as the regulatory X of ongoing study to engagement providing homocysteine data the have of on study by a the details X with Cohort Phase pivotal of are later Phase our on total the alignment finalizing progressing hand. now forward the

over With that it the commercial to update. turn for I'll Peter Peter?

Peter Heerma

everyone. afternoon, good and Thank Jula, you,

is standard since FILSPARI realize treatment ambition pleased this at disease progression. have of ambition. to in started risk make launch to a I'm igAN Our X.X rapid we new And the patients really for months how first

our have made approval strategic February. significant that call on on We three I progress fundamentals the in outlined

First, enabling patients and changing of profile; increasing safety and nephrologists. the paradigm and initial efficacy FILSPARI's unprecedented coverage; patients for novel treatment access about a experience payer eligible action with to educating mode positive third, physicians by for and ensuring second broad FILSPARI

patients further sustained been engagements nephrologists provide proteinuria FILSPARI's disease novel me the action force of intended with impact. able some dedicated those Nephrologists reduction with are increasingly focus X,XXX face-to-face In has and for of areas with IgAN provides call understanding are on that mechanism of interactions. Let Starting launch. engage our at launch for risk three our in rapid progression. physicians. having successful to rapid including in you These field

awareness market is about Based continuing already prompting. nearly without see FILSPARI. on and in XX% of of awareness research findings, also aided over nephrologists know We two-thirds of the those at the surveys FILSPARI increase

intent XX% therapies importantly, nephrologists remains year advance FILSPARI of first the XX%. substantial seeing high other the as to treat over these at a of within approval More report and

demonstrated platforms is the campaign quarter. XXX in expect increasing launching also our since we months XXX has translating force to awareness can using approval, by strengthen in accelerate positive start also total This patient forms. have speaker programs approved Now And of of further behavioral FILSPARI. branded in X.X while start we new with consistent patient changes for materials demand. received into as momentum the field resulted This the products, second FDA a guidance first

these nephrology the launches key to perspective, metric period. benchmarks patients As the indicator demands. it were patient our we these into fundamental FILSPARI launch. within confidence To forms for view start rare first we have And forms XXX put since When the our received the new to this highlighted, full for successful start the in outperformed recent the treatment as demand is approval contributing comparing other in quarter. these same

Additionally, by increase potential the to number for FILSPARI. that repeat treatment of their IgAN with prescribers indicating same in and we benefit to and the nephrologists, starting are an treatment addressable continue paradigm patients observe seeing change they prescriptions their

been Let me that we now making access progress shift on front. the have to the payer

pleased is investment been early very perceive the utility The the bringing understand to we and the payers with developing of and value the FILSPARI how with are evidence We generating payers made story continue they economic that we health the helping on value patients. FILSPARI. have in to has engagement important in FILSPARI

have these for policies these formularies line. covered authorization policies. We allow US have And aligned of the second prior the with with are quality specific XX pleased of ended FILSPARI-specific with in we access lives most really that payer as about that quarter of formularies with requirements XX% the FILSPARI

FILSPARI patients dedicated get a TotalCare support Travere start is to quickly that team. key patient a services after priority patient receiving and access Ensuring for form our

with pleased and TotalCare support personalized assistance are to ramps education the and process. patients being This reimbursement We how the these are patients. more and services that by includes is appreciated importantly, providing with Travere

free long medium QuickStart periods. up products XX limited patients TotalCare for undergo eligible days. claims Travere and can provide Reimbursement to through with program the

line fundamentals months is progress a our the a million FILSPARI total in of net in in which net mentioned right quarter four Our in sales $X.X $X.X million expectations. these the first in with three launch, resulted of on half before and since second and revenues

revenue in at first the our a placed recruited specialty pharmacies pharmacies in stocking the the reflects our quarter I'm expected, that have inventory the initial was pleased specialty regional reduction centers As since second of from that reorders. in quarter.

launches access. we We for In at overall demand looking really rare see broadened pleased. the our of the have quarter second recent nephrology strongest launch second the payer and in launch are through the quarter amongst high-quality

in expect half start could variability seasonality to in any the of seen inclusive months in we recent nephrology we forms rare other year, second as result which the quarter-to-quarter. of In from see the launches summer growing some have patient

to expect access to decisions us to continued will advance also FILSPARI. coverage enable that see We successful

meaningful With the strong FILSPARI expect revenue and demand quarters. the growth for broadening reimbursement fourth and we third in

at approval. our set this of and with consistent All is planning expectations we that forth

our great will And rapid standard we has result progress-to-date treatment we becoming sales created risk patients as goal blockbuster a in a foundation. FILSPARI of very Our for IgAN new a that progression meeting strong at the have confidence ultimately achieve future. of and potentially

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

Chris Cline

good Thank you, Peter and afternoon everyone.

As the year been a to that of still progress over we the months with we're to six come. has the highlighted, and the second pleased are team first forward looking strong very half has made

to we're support Importantly, from financial well-positioned perspective our growth. a expected

from net For of the were attributable million FILSPARI. second is product compared the net increase of in XXXX. sales The sales primarily for quarter to to ongoing the $XX product same XXXX, $XX million launch period

with million was and bile products perform contributing acid contributing legacy sales product products net also driven in patient in growth net sales. demand. well million quarter continued This portfolio $XX.X $XX.X second the to by the in Our product organic our

During million XXXX. we in $XX.X which period of collaboration and also the million quarter, of $X.X $XX.X same revenue to translates the recognized period for for compared total to license the revenue, million

the for manufacturing. COMPOSE well for million were the quarter is the XXXX. pivotal program start-up the second including advancement as for $XX.X expenses Research difference to development in to program largely of The $XX.X the study in compared attributable pegtibatinase million and activities as our of period ongoing continued XXXX same

XXXX support and activities the R&D adjusted the same the same for quarter is first difference program period team compared compared expenses $XX million in FILSPARI million for as $XX.X were of supporting FILSPARI the to XXXX quarter onboarding to REMS for the well the second Selling our of for staff XXXX. including million The quarter. the expenses $XX approval launch-related a the largely promotional as in On XXXX. field period in following and non-GAAP administrative million attributable and general were $XX.X basis, of to second

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

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

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

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

Eric enter recently for This our clear for portfolio benefits product is to bile to to strategic to million. pleased Pharmaceuticals Travere. acid As transaction and up highlighted earlier, we $XXX agreement into sell Mirum were the financial

From a the at million our several with forward value financial will payment perspective, and from bring meaningfully years strengthen this $XXX of products balance close. an transaction of upfront sheet

in and patients to realize have Chenodal potential treatment will be sales-based options $XXX important up as Cholbam from continue we Furthermore, to million additional to milestones in value the the future. for

some is year, bile to the half our first we close and expenses the variability advance the below quarter. the as in programs of continue our quarter-to-quarter the levels remain to for transaction which third reported half with modestly the to at second acid portfolio the expected For anticipate we of operating we or year, complete

and the can portfolio manage quarter sheet from beyond Importantly, bile potential. key we and expect expected achieve the balance with acid of our goals operations programs the support our transaction growth from XXXX, reported end our we at to significant with net cash the second that the proceeds balance

With for turn to back closing that, I'll now over his Eric? the Eric, call comments.

Eric Dube

team's half in patients first made disease. rare of XXXX we and proud the delivering with innovative towards progress I'm you, Thank have Chris. for the treatments of accomplishments the significant

to is an remain Sparsentan status peak. in profile the look start near-term. blockbuster outstanding the of engaging which forward and of and track to performing with our by the FSGS encouraged had at to on FDA FILSPARI, We We've reach potentially the expectations in launch to high

in the Pegtibatinase data study evidence of from in to the the become potential market treatment Phase future. COMPOSE further X/X potential represent disease-modifying multibillion-dollar only its a

the portfolio our our further by And and teams divest, able efforts goal bile into be exciting years significant on ahead. our will their with to delivering opportunities acid agreement, the our of to quarters value in concentrate entering aligning pipeline

urgency. of to year, important forward positive the continue rare make by potential on half providing therefore, of we impacts those lives programs. updates impacted our the hold execute milestones pipeline the In with the second to we disease look These on to will and meaningful

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

Naomi Eichenbaum

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

Operator

now Anupam Rama, Thank from question is [Operator the Rama line take you. Anupam Instructions] from your JPMorgan. of We will first open. line the

Malcolm Kuno

Thank actually is This Malcolm Anupam. Kuno question. for on you taking Hi. my for

one the what Thank benefit? suggest question, prescribing possible of Just under does your eGFR habits market scenarios research about various you.

Eric Dube

will Malcolm one great And question. for the to over turn thanks Peter. that I

Peter Heerma

to PI about to materials is, with the approved I this that what Yeah, I accelerated approval. kind Eric. way launch. Thanks the would a only We FDA guidance the consistent think promoting rolling FILSPARI like started are of it's would say through you

past the adopters targeting this in for curve have an every what XXX, ability launch, focused early we our and promote. as plan And are efforts. we is innovators to adoption and we day Now that with there's in

profile will FILSPARI allows I for the will broaden more your further To and base. help with And to question communication we us think reinforce prescriber this new the data opportunities. further

Malcolm Kuno

you. Thank Great.

Eric Dube

you, Thank Malcolm.

Operator

from line line will your of from next TD Van is We question take open. Tyler Buren our the Cowen. Tyler Buren, Van

Tyler Van Buren

of to and you. received. have coverage. of it for to Good approximately understand XXX for to them how are also are the covered forms on receive taking afternoon. XX many how drug? of cumulative days then that these Thank up potentially you question. But say Thanks XX that my patient Can start take patients I you could many

Eric Dube

And that question, don't the for Thanks Tyler. take you Peter, why one?

Peter Heerma

our take this to are the rare are, I the say the at look launch will I metrics happy line disease especially highly variable. beginning Yeah, process question with the I you metrics that in right Eric. where fulfillment early If we of expect as in launches. are benchmark would in would in say

have positive payer on most FILSPARI increasing a we coverage question received the your forms, of I decisions will say in we of that can conversion patient include reported to And patients continue And believe to to XXX that start products, with paid trend FILSPARI. these formularies. see

Operator

of Greg We question of now America. will next take the Harrison with Harrison, line your Greg is the line Bank from open.

Greg Harrison

afternoon drug? approval. now do question. expanded Hey. And the in In on progress. to would FILSPARI that congrats the the you along noted the And it remarks Good the how prepared could for What you and label with that, was impact the expect that change all get population thanks full be label? the would addressable patient taking think

Eric Dube

Greg, thanks question. for the

indication So patients would than per is the full reflect our one expect that in statement studied our PROTECT did is progression. label day we which what patients that, we population far enroll in rapid what risk of say to those X now and which the have gram Phase are would trial above broader that we I at

on grams. was patients those approval. through Typically, this approval FDA's assessment X.X accelerated of And above based

at there about the through efficacy So, that might population. seen the be expansion least that we our how in we the Peter do believe Phase addressable that an have And X broad I'll have talk again will interim program. impact to reflect

Peter Heerma

two there's here. elements think I Yeah,

us I to broaden it helps how patients. addressable further think about physicians think their

able of a may data something physician to now. the I for with that right was further confidence our be one. out that calling planning have sense been broadening the provides efforts. And we base. think also targeting a I that's reach. that have in it become nephrologists been we XXXX And that there new think think But I prescriber that's will I that

after the the We base the the ultimately announced prescriber the second updated I expand that year. come. of FILSPARI see of addressable ultimately, to further patients confidence will to years we label good think we for and continue X,XXX we half to broadening with in have me the planning have the nephrologists gives growth are broadening to of for that And data and

Greg Harrison

would one Great. the sneak the Was flow in start throughout maybe of of characterize how new more That's accelerating helpful. it patient the If end you I could or forms QX? towards quarter? steady

Eric Dube

Yeah. would to Great, Peter question. like you that? take

Peter Heerma

say, Yeah, I increasing. steadily Greg. would it's

Eric Dube

think that's reflect right. Yeah, variability in with is that What is I expect first would I that it's we've as there the increasing launches year. and would seen we other

the of payer will of of well Greg as Importantly as about forms talk those second patient growth we overall given certainly in an in would strong that year half expect of seen would half though both what the expansion revenues both access start well in as we growth we've in as demand the be the back great reflect in that as year. the this

great to some would medicine quarter-to-quarter But month-to-month see our we in therapy making blockbuster the ambition position to FILSPARI in IgAN. But a and foundational a ultimately expect we or achieve variability. certainly are of

Greg Harrison

question. Thanks for taking the Great.

Operator

the We your line will Partners. is Joseph Joseph with now open. take line the next of Schwartz, question from Leerink Schwartz

Joseph Schwartz

into that could much powering congrats quarter. on and some PROTECT wondering assumptions design. us the you I walk so the Thanks have gone through if was of the

total X.XX all then also slope. a came incur X.X was a the per that out then paper but repowered you min a I total a a in weeks difference XX% study, think detect curve predicted unit difference mL somewhere I produce I difference proteinuria would that in year in by XX eGFR And think per powered slope. it that in XX% to eGFR proteinuria and saw PROTECT difference after

since I think to X.XX interpret which studies sparsentan in that a relationships curve these expect total And given so wondering eGFR unit usually relative XX% produced changes drive I'm to for to how slope see. they companies smaller power reduction incur than predict would actually difference

magnitude How evolved so the given I being drive trial FSGS of just relationships with and the And powered? that is PROTECT? to time. see How sig a smaller changes it stat these over repowered you meaningful And some a in we've now? possible was have heard changes question, powered initially would maybe my trials to clinically do small be it's of guess respect ones be could very been still result

Eric Dube

Joe, Yeah. thank for you the question.

Jula I provide to able that poised is on be well question. think clarity to some

Jula Inrig

Thanks, Joe. Yeah.

you're Just to clarify correct.

per to least XXX We per detect that's in which on mL of achieve. originally And the data a X.X with did XX% XX% slope proteinuria in how have and you're that minute year historical power difference we at was greater achieving difference patients. than a we based powered correct trial

the as said you now pointed in interim for reduction So have relative achieved we additional data as predicted. out XX% interim we greater analysis proteinuria, was a and example, we our data than which you

support effect will at achieve clinically we us as So of two available that is clarify did to approval. that recruit. based we gave a power analysis, and which a conditional meaningful years thing want high data level over we did calculations I our the on this significant confidence interim didn't repower, statistically did eGFR data well but as and did accelerated one trial-level

level do that confidence achieve continue will of So effects. clinically both significant meaningful and have high a statistically to we we

remain need just we hit at on. based the I we the additional powered effect I also And we will and two based to highly It's don't significance as But yes, hit what add statistical on that think data variability. on confident we years. that, treatment high of originally will

Joseph Schwartz

very Thank you much.

Operator

Maurice will your line take next of open. Jefferies. line Raycroft, is the question of from the Raycroft Maurice We

Maurice Raycroft

separately wondering past. PSF for it And also was thanks the conversions? on the on which to is and my related XXXX taking are and the or progress thoughts your year latest REMS I full to consensus relates what getting implementation? the year And on number you've access impacting in FILSPARI this question. Congrats for commented feedback what you're Hi. the wondering how as revenue REMS for

Eric Dube

Why the question. start don't I revenue full for the for with thanks the FILSPARI Maurice, year.

see been an we to-date of we've are we the generated think acceleration the that saw with half. think year. second revenue of in I very pleased in demand And what this half that to fully seeing the with launch first expect I we

rare largely good consensus, have how think, with first other we in renal gone, in year With I line there. we're position a sales that think

see that So that believe other the in seen we're that launches I half potential with of we've we months renal second a seasonality to rare the summer strong year to date. the going think including of some

turn So is feedback the treatment to to what for a on about become in means give foundation for in in for some he's what it launch. well-positioned I'll the terms this strong year foundational this I a And certification of again, us think conversions. Peter the first setting paradigm. blockbuster we're over really REMS and hearing therapy to

Peter Heerma

do so demand able let generate referring And program. the what with the the that when are treat, would at considering the start efficacy the first and for Eric. forms These I by thanks Maurice safety combination with is progression. strong have seeing in his physician profile of doctor that rapid say, to to patient conversation patient that is risk will we her appreciates to FILSPARI of or are Happy half. were for XXX we urgency me the the FILSPARI And in start the the Yes. question. generated to REMS

was nine before. really comes it first the talking the to fundamentals outlined in we months And first back about year on foundation long the that I Eric the think building six to so have months focusing

positive novel So ensuring mentioned progress as as this profile educating community experience. plan in nephrology we are we and FILSPARI's efficacy and safety this first we for action in call comes like of the back this solid a the year. and And to mode as well making on really

Maurice Raycroft

Got it. for taking question. Thanks my

Peter Heerma

Maurice. Thanks,

Operator

Blair. of is open. will take Lugo, next William Tim line line our question from with your We Tim the now Lugo

Tim Lugo

good on question Thanks for the and the quarter. congrats

acid maybe launch? few And being will over margins bile should the carved next the to out, portfolio expect quarters With gross we the gross trending margins how maturity? during be trend then what at

Eric Dube

Chris, why don't take Tim. question? Thanks you that for,

Chris Cline

happy the for question, Yes, do Tim. to that. Thanks

the the to in see portfolio. some In be and closed be can carve reduction for But and what be on terms available. acid once point will of R&D. related that and have gross out margins expect bile will come that comment to for to we able that is specifics to transaction us statements of SG&A the both will I do in to a forma That easier you we've expense it pro we

into that think you've a SG&A force CHOLBAM and is small And go that. you promotional supporting that efforts you've got sales about got when

So perspective, small then have from some Phase that a as work. to we Chenodal would X R&D well that's do study support And ongoing an and regulatory transition. biostats as

those And margins more forward. to as to expenses forward detail bit transition as will a move go on do and we'll go as the there that able so expect be in specifics we we we

to everything far commented expect there that. net we've we In perspective in margins obtaining you with stable a and thus a teens for gross on we far terms get launch, state thus of at see high the historically to mid- that to line of and really least is

Tim Lugo

is consensus were the the is? what consensus you like some And also impact enough. together seasonality assume Can with summer, mentioned put comments QX Fair pretty Are you would there renal Okay. in in which QX. it QX rare I in about you some sounds destocking kind launches. and comfortable assuming with other but those then reorders line of

Eric Dube

variable But still some is in and part convert demand correlation there a to we with of revenue. forms between we meaningful patient as characterize And think seen in be access, QX. that ramp were revenues. a start pull-through really generate tighten in expect to half we've do can in lot second it to see of launch and a to I first we is do access we our I that will what see the year, a demand And the able the great the of a able time that think QX, improvement in expect to Tim, to paid even So it in of payer in scripts.

start that and going closely to quarter. we third we then to through to see So really really tie should play think patient year start that's start revenue really in the by the the this of end together. forms And

to their But that of year. first expect last launch, revenues of that the The within in our the space We the close continue in of mention deliver and the the quarter year. generated we're first to the is I is confident other to we step taking a are see ability other expectations still we're on execute and here. to in to those think back, half was have that thing off that but with I a foundation will to the that strong meet fully start demand we talked generated strong continue Peter of about very could year that of that something in XX% lay this many launches that

Tim Lugo

you Thank much. so Understood.

Eric Dube

Thank you.

Operator

line of Bansal with is line Mohit Bansal, open. your Our next Wells comes question the Fargo. Mohit from

Unidentified Analyst

forms the sales for is launch metric watch better current this And Adam are two What focus the ensure areas Hey, the FILSPARI a over is success? start would to or quarters? the to be of Mohit. next on

Eric Dube

are Yes. by that's very think one? earlier best don't reflective truly take patient great focus. And It's indicator. start question, by is as that I I the physicians. of a patients we've say in I strong the demand It would lead forms launch seen Adam. underlying a and Why

in Peter last quarters as three think laid it what launch takes a access of this. for to about I lay now we calls increase have couple the an like and out that is in foundation

forward. well so reflect get I really of revenue as we that do there. we success level to that. start be through moving the a positioned QX, do we're then measure Once and demonstrated think uplift But high meaningful out of see And that, we forms should in patient in to expect demand

a successful again, continue will come. to we'll have rest to be of through the that very positioned expect And in We the years the launch year.

Unidentified Analyst

Great. Thank you.

Eric Dube

you. Thank

Operator

Divan our with Vamil next the take is will open. Securities. question Guggenheim Vamil from Divan, We your of line now line

Vamil Divan

the and the all taking Great. Thanks on call. color for questions the

a or to after as insights on can added which of given of are versus the in being sort prescribed ones get trying is in sort on they I'm of before little of be the maybe setting insight academic maybe other SGLTX you. is FILSPARI. sort sense just get into getting they TARPEYO So Also patients a Thank fitting helpful. community that's TARPEYO kind of product any just would being you SGLTXs? are the on there more top it Are prescribed how this prescribed of sort just an profile the of provide patient setting? exactly the being

Eric Dube

Great. don't why those? you Peter Thank take you for the question.

Peter Heerma

for Vamil. Thanks question, that Yes.

I patient So think characteristic.

think I call. several would I items

from from the payer I very are a is patient think patients onset expectations. is our predominantly male. commercial that with a perspective, those of much first and that that we That's two-third in line coverage expectations. It's in said population also what line our is with

you RAS like with the and a But replacing does are see we is question physicians that in these are I this in right and asking where we ARBs. rapidly patients that seeing are paradigm? it those fit think particular that mid-XXs. age often that is understand treatment together the what ACEs on average to progressive were it Often is as early And patients inhibition on the is SGLTX. now start

So that what it's or those combination we seeing often in replacing being ARBs SGLTX. are prescribed for is right patients but now, that ACE inhibitors are with

with ARBs top To question FILSPARI it ACE being and TARPEYO, your of later like are that's as general but see other now resource to on used with we well. or in regards how a still it's steroids

Vamil Divan

Thank you. Okay.

Peter Heerma

Thank you.

Operator

is with Wedbush your take question Chico We Chico, now next from our Laura Laura Securities. line of the open. will line

Laura Chico

quick I afternoon. for ones. Hey, taking two question. had the Thanks much good very just

label, Eric, this any you to not label are that just patients of expansion. potential respect is I of asked might kind proteinuria threshold following but think And bit on they moving kind are to into population have waiting set? the on kind up with earlier begin first of label So that seeing some your been below comments a patient indication there little of for the expansion or indicated that

real meeting expect are upcoming with FSGS, we range quickly, the And from then of the what that just outcomes should the FDA?

Eric Dube

Jula the and take question. one first the take I FSGS don't can then Why Great.

proteinuria, are are grams determine factors progression. level patients that X.X physicians So are of other because of of we risk that some below do there seeing the

So in are in if can But are treatment seeing that early few really any launch of we most armamentarium. imagine you very that. patients as the have options severe, the most the

us the approval that do treat, in we available level expect full be within number So, of but help will would increasing patients of expansion the a would label. also that evidence that that to label for just be

moving is So as mentioned, forward. rolling sort a launch with Peter evidence of and additional support

I think the about patients pleased we've Jula, you are that been potential outcomes at those that for address have clear about risk. the So, understanding don't parts why with helping treat question And with FSGS? physicians

Jula Inrig

Yes.

data I results call, we to data trends seeking outcomes durable on an positive a proteinuria for a analyzing interim really profile. which and to overall as all We're update said released a on you to we accept willingness that And and we we provide submission And FDA, on hand, position we that's mentioned, effects the shows have released great the submission safety DUPLEX have kidney and a with analyzed. later as we've scheduled. trends already in fall. the the based totality in to we expectations the a really in understanding meeting positive be So on eGFR agency's to expect have the additional the which data with and that of on do then been

Laura Chico

much. very Thanks

Operator

Thank you.

the Alex your with from Thompson, line now Stifel. line is comes of question Thompson next Our open. Alex

Alex Thompson

Maybe blood for and patients what XXXX? the may patients could could in and around Peter, liver setting of test talk monitoring you then about in the And Great. is on so color ongoing Chris, your getting assumptions past any therapy course second which guidance far? are a Thanks. you Thanks. maybe be provide runway for embedded

Eric Dube

right. take one? All you Peter, to the like would first

Peter Heerma

is we're started thanks that so absolutely. understand compliance. like far of the that is question. of prescription Alex, Yes what repeat like high a patients your the and testing. What FILSPARI with monitoring have I you seeing level the for there FILSPARI prescription repeat liver is If correctly of

that see but liver launch, the so So at on we implication It's testing. or compliance. any really monthly there don't high on with is point this complication far the

Eric Dube

runway. the Chris, And

Chris Cline

to happy Alex. Thanks Yes, take I'm that.

in guidance the are runway things. included So cash of number a

pegtibatinase have steps. next nephropathy year. course evaluate second ground FSGS is FDA launch, baked discussions in investment for of the maintenance later and with those this the and first getting the of IgA pivotal being program off disciplined is Also, into spend that while The we

the potential then, and would going pressure different that and various milestones for dynamics into as Thiola receive bring that trajectory. continued we a result are that also business. and/or forward on any pay sales competitive that We programs And of either

there. what's in all you gives that good a hopefully sense So, for of

Alex Thompson

you. Great. Super Thank helpful.

Eric Dube

Thanks Alex.

Operator

the of now is open. H.C. Arce, your next comes Our Wainright. question line from Arce Ed line with Ed

Ed Arce

congrats my really taking just the questions for some A and Thanks couple in for prior me on follow-up on quarter. the questions. Great. progress to

so one proposals or power And secondly, around gram if or proteinuria wanted or that get X.X perhaps with, with better to First, around some more can a include in longer the just new the to period later description the wondering particular would more the aspects of correlate you're FDA patients on long-term I you to the would you outcome whether of if FSGS, the or some little of year after then a with quantitative grams of size a IgAN, perhaps down label eGFR. Thanks expansion some other higher put expansion? patients around from scenarios a regard the in the that to meeting label incremental type lead-in bit meeting with this now go trial coming granularity much.

Eric Dube

at I question. Maybe FDA a take scenarios. stab the the for you can thank Ed,

to think FDA for to I submit this that us I we've would undertake view point. our totality trial a generated that on that of sNDA. the for data don't date with looking would foresee we really sparsentan sufficient at FSGS align to we're large fundamentally, an in be

Jula, data that? would any think we that the have that sufficient. other to you add is I like to color

Jula Inrig

what on and a to say. them, patient discussion population available a trends totality data about else this Eric and the the them and profile results That's have a to in would is positive data consistent very many and them, able to the we've to show I see and has little proteinuria consistent echo meeting a them generated first effect being really had with meaningful really that safety durable really of just And steps. that really points. have first other a end to next on conversation our

Eric Dube

expanded take would question the you to population. like Peter, about the And

Peter Heerma

you I that. can missed question? Sorry, repeat the

Eric Dube

for at question might many the the quantifying, is patients label additional with expanded full there how IgAN Yes, be approval?

Peter Heerma

Yes.

a high disease I X.X, exclude risk there because generally that that rapid label may that the think determines patients other the below is X.X. patients physician patient now why a though even of realize for progression. is to of proteinuria a doesn't right higher progression, it factors is That important on with than at path be

base, communication. earlier So a see X.X. and because utilization see I broadening on will point the we that opportunity But call I label also broadening I of with prescriber the profile confidence made further the the below think also the think the for to we that in of provides

Eric And prescribed patients start what prescription that's hear really have their in as to that and own earlier, had well. launch options. mentioned And initially not And the patients that stimulates treatment in we with as other being are can start means as pleasing. for what to physicians success repeat often and any that's you see do FILSPARI

Eric Dube

Yes.

I I maybe XX,XXX to for us add with to there are with thing that expands addressable up the factors think, nephropathy. assuming given XXX,XXX be going there's think XX,XXX the IgA to that two is, only population U.S. the in now patients I other would

a there's that that patients have proportion the even reflects that at increase of been the grams, a be very may them addressable those data I I considered that that patients RaDaR may Jula have now have from that below risk X.X. analysis patients think we to low think those risk progression. fundamentally, are are going And compelling it's that of X.X shared set of

So earlier in as increased more we IgAN have education there's to to awareness as as in years going diagnosis well come. at I the risk of think be who's

that different population just not label several expand to actually likely there's are addressable the So, expansion. in factors the

certainly population can the we about quarters, that talk should but factors there that meaningful are future several believe in do forward. expand that So, we moving

Ed Arce

Eric. you, Thank helpful That's Great.

Eric Dube

you. Thank

Operator

additional This concludes the call closing will back today's Eichenbaum question-and-answer any to now Naomi for turn remarks. session. or I

Naomi Eichenbaum

with Have to quarter all again you the Thank remainder speaking throughout our concludes evening. you. forward great update. of look the keeping a We and of second your rest updated year you This soon.

Operator

Thank now disconnect. you you call. today's concludes This for may your and participation

Travere Therapeutics (TVTX) 3 Aug 232023 Q2 Earnings call transcript