- Earnings call transcript Q3 2022

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Operator

Good day and welcome to the Travere Therapeutics Third Quarter 2022 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, Carrie. to update third 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 for the be Dr. joined remarks and Chief Medical Officer. Heerma, Commercial Chief Jula Inrig, Chris Officer; our our Cline, our Peter Chief Officer; Financial Dr. will Bill Rote, Development Senior the for of President us Vice Q&A and Research join session.

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

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

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

Eric Dube

you, and and Thank welcome good Travere, afternoon, to Naomi, everyone.

the meet potential therapies our during of to quarter, the being development in H if sparsentan growth medicines, IgA standard, review FDA for a FSGS During access of ago, as approved. broad patients currently become update and available. become diversified for label priority to rare the position continued as nephropathy in continued third is our we positioning come. for quarter, advisory weeks treatment were expected data pipeline disease to no that to approved have pleased this we committee it a toward update, time, the and regulatory objective draft new first been our by on And received the of provided of potential global organization in of we strengthening leader through we or In approval. new for sustainable, to We a to continue of to position being a that no requested with needs to and our sparsentan years while vision accelerated Notably, for nephropathy, IgA is execute efforts the community. the the Subpart did report the NDA have our that support a A review trials as part non-immunosuppressive with we therapy under couple our process. on new our that

updated our expected continued X-month sparsentan. have XX, now strength February the the XXXX. cycle which proposed of FDA Perhaps REMS. for the our planned extension with enthusiasm supporting we unexpectedly our interaction, our of PDUFA notably, very is incorporate that pleased target I liver asked we we REMS the into recently received report have During and did the confirmation of submitted monitoring been am late our clinical of date, profile to to most pleased data us meeting action

date, of from like also a the our I ago. the REMS submission to the extension is to feat prepare highlight no his great to while of couple a PDUFA This a and this launch standard. teams continued Peter of small the new nephrology launch the resulted our testament whole organization is prepared as November. and this a target have weeks since has strong We of it to were and to to position treatment for well provided was a teams would an in hear that in potential update community revised action

nephropathy working support have conditional time U.S., the Vifor We patients We pleased review of the and community we to even best were we for for our the be Outside EMA to understanding nephropathy. review we partners successful for second on with launch. the can the enhance marketing decision in for authorization IgA a our added how the prepared XXXX. application and closely very throughout accept more potential treatment of in review sparsentan process, further to utilize the and will CSL approval the expect forward half look of for a a IgA providers

submission, assuming are FSGS. of to we on And in the FSGS top in data bit and X-year nephropathy, we more in supportive the homocystinuria, to progress an endpoints classical the of would detail X forward IgA quarter ongoing in submit enables we're in to Duplex enabled Phase Study next an sparsentan, anticipate HCU for to our advance a But with to a half subsequent interaction European year, be our towards of being pleased line from variation the we a or as into position application. of sNDA first shortly. biomarker Elsewhere going and regulatory during primary to CMA the continue our program data which Lastly in the year. our study. pivotal look pegtibatinase advance. Jula be the with approvals pleased next endpoint a the on If half second regulatory homocysteine -- the a utilizing pipeline, will path us continues total in

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

Jula Inrig

afternoon, good and Eric, everyone. you, Thank

We rare are continue regularly to that options seeking physicians non-immunosuppressive kidney to disorders. their hear treat patients treatment and

and against inhibition in proteinuria in single confidence this in become sparsentan non-immunosuppressive of approved, control which date the greatest the that in standard. sparsentan only an nephropathy. sparsentan active be nephropathy first continue relevance IgA agent IgA for treatment can we If to reduction in a has and it new progression, in is angiotensin molecule pivotal to for the is have disease pathophysiology a that the development, study would ultimately approved the shown kidney Importantly, pathways causal blocks treatment non-immunosuppressive namely molecule of and two a The endothelin only dual pathways.

priority a draft our update label, review As to our nephropathy, pleased we weeks it the moving relates in received have ago, IgA were in appears noted we in well. sparsentan and under for be that that to overall -- process X update our to NDA

As the not our receive endothelin REMS injury Eric communicated to with drug reviewed monitoring. will intervene that treatment approval request unexpected liver being the other serious been induced liver made final being FDA has I for did us include the part is to in highlighted, this sparsentan we that and request reiterate associated an while database be options under in that pathway. that accelerated pathway, will because

related that nephrologists a would desire program at the first nearly injury there as studies diagnoses been were liver between have blocks medicine the endothelin. adverse events be time ALT/AST be the of XXX and to to of a comparable Most of related would the no or Additionally, us and to which time to and standing monitoring interest highlighted of elevations participants using irbesartan. in it there was was in data clinical have this importantly, reported sparsentan date, Phase X our sparsentan both analyses control active education

updated Eric, As from you FDA. our heard have the proposal back to REMS we submitted

number the support for learn REMS familiar weeks. liver their the It's REMS there to nephrologists and been to patients, able also of recent important is a examples And physicians and convenient note practices monitoring staff. are we've with for that process. that make from already goal to their and have been effective many Our

with labs confirmation of monitoring PDUFA patient, for the XX function order the seamless practice. nephrologists received and date We and FDA every Additionally, routinely look work to their February so new review with tests to next X-month action the be of labeling current process. and target monitor extension liver through clinical should recently of We forward year. our continuing

We with the the in physicians education our further the supportive to our field. work use nephropathy opportunity extension disease patient the advocacy will state and nephrology provided by for IgA groups

an are Our favorable FSGS and We nephropathy, top path on conduct both with a sparsentan the DUPLEX data X next we track is for year, pivotal sNDA in that readouts end, believe the the a studies ongoing year. manner. sparsentan IgA and remain we pleased in are X-year if that as To approved progress line endpoints the submission progresses DUPLEX for PROTECT our for continues we next planned. continued and from X-year Phase of the study on program to to

expect will and in of for be nephropathy first half the of the this XXXX in half For second IgA FSGS, XXXX. we

of Lastly, us to to cohort FSGS gather have now for to we on excellent to sparsentan. to to the towards the Phase sight with a the extension, patients pegtibatinase from poster ASN and data engage two report our Kidney research sixth in X in will from advance Week our program, our open-label and including nine composed believe an our is nephropathy occurring we ongoing I views that turn We that nephrology which I'll development. study, completing critical forming and opportunity next pleased which This from look pivotal am growing of cohorts week. both oral for of community. sharing IGA the Phase is for insights of presentations. sparsentan be in continues X/X enrollment all presentations body to line forward in we study. our first five continue

commercial to sound with We learnings new the our believe design to therapy designation pivotal I for pivotal rare and with am and the the we're disease study. update. in primary to clinical the over to progress of the a of supply our continue system continued multidisciplinary the by the the utilizing on biomarker burden pipeline total building regulatory I'll deliver official on FDA options We'll our very we supply from for community. global work and commercial progress our to for also endpoint second now as parallel Overall, breakthrough interaction be making of guide align to Peter? us homocysteine needed make utilizing continue readiness. interaction [ph] upcoming this completed greatly meeting In pleased turn afforded the to potential pivotal treatment phase further a a through towards work, the development Peter progress and study. call to to

Peter Heerma

you, Thank Jula.

potential continued products in quarter, towards IgA the deliver to commercial build nephropathy. our of our approved sparsentan During and momentum certain third organization the launch

approved quarter of we products, across portfolio. the solid our another demand have So commercial

Thiola, performance with the despite are we competitive continued evolving pleased For the landscape.

pleased we identified, dynamics with As net Overall, this we sales. affect the generic patients year, we in ahead. impact about quarters supported remain talked into have we And seeing to treat further community. how materialize of homocystinuria continuously the and we have are expect throughout

long the quarter. efforts The asset [ph] pediatric team continued portfolio growth to continues solid these as bio third a educating as And [indiscernible] been Our have field well has key to deliver in hepatologist. success. to had standing dedication Goldman geneticists,

we if approved. nephropathy, our IgA sparsentan footprint established prepare allows in for successful us build Our commercial upon strengths to loans of as

February. in serving familiarity launch if people of X record commercial by sparsentan has This our serve. of completed Over is completed for we standard sparsentan and new remains the execution to a been confidence for access as and a identifying, our note, nephropathy rare we our potential trainings will and diseases. expect have a prepared last affected great better timely track patients years, the treatment We has gaining built treating team in treatment allowed for strong in nephrology. have efforts indications. in has The support and recruitment to they we November, average to monitoring, in would specialty speaking that approved Of a organization launch have nephrologist with team was nephrology within seasoned our After This experience, established about years preparation a it the the to even expand an sales approved. initial and XX And new built result, has mostly IgA unchanged. communities nephropathy liver for sales patients for become to that group positioned nearly in IgA team of believe force. of requirements REMS sparsentan be

people heard IgA As progressive that the address has greater. been nephropathy non-immunosuppressive for active living pathway never treatment for you need Jula, options the with from

study, has a and We two antagonist, that is receptor the dual the of X sparsentan would development nearly disease. be As With treatment ability non-immunosuppressive believe sparsentan and only what that IgA to contributed in Phase if sparsentan critical pathophysiology endothelial inhibits that the angiotensin demonstrating treatment pathways and proteinuria the is the our by reduce control. in the approved. nephropathy, fact a an active first to indicators against for XX% pivotal results,

XX, at in believe could on XX,XXX we additional be what population monitoring we process, uptake to REMS more United frequency the expected. a have in and of We onboarding originally gradual Based of the the understand continue the But patient research will further initial these result and an today, we continue in to dynamics. than doing to know there patients will once States. education addressable XXX

learned make similar already for believe a the patients. will success education of bit REMS. that staff the our have have key to in the most needed come from proactive process quite very type the of with other We to We programs done providing and studying well support physicians, and convenient some

time With approved. the team the successful from even our for be for sparsentan PDUFA better loan for nephropathy, will added if extension, position IgA

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

Chris Cline

Good the as financial well-positioned strength organization. change support Thank continued afternoon, trajectory. our well development I'm our our you, We're pleased programs as upcoming growth Peter. to can the potential that launches meaningfully with everyone. ongoing of

XXXX their same reported collaboration noncash for of the with For consisting reported attributable product in collaboration sales of continued selling, headcount and $XX basis, XXXX. of million CSLB of and expenses revenue in million total On and the GAAP and XXXX amortization. and $XX.X compared the a European This million, adjusted quarter the programs, to noncash $X.X to After basis, from sales of first and approximately for and million XXXX. Reported in advancement impact as compared the to $XX.X On in of quarter amortization. for Significant On launch expenses for. million. research adjustments third to largely the compares XXXX. we quarter period third compensation R&D net third attributable were increase loss consisted affairs in preparations, noncash million as basis, net for quarter sparsentan well GAAP quarter medical about activities. expenses for million Relevant On million were the included $XX.X adjusted the for for $XX.X quarter of a revenue to development the stock-based support. largely including the administrative $XX.X an XXXX, increased quarter GAAP $X.X of The commercial our and third net a $XX.X XXXX. collaboration and a compensation third $XX.X reported million XXXX adjusting The $XX.X tax, revenue expenses of million were increased million headcount $XX.X is XXXX third including million for we increase expenses an million. were stock-based basis, quarter for third of of XXXX. of expenses the SG&A is $XX.X news quarter of for general and non-GAAP loss income of the product depreciation

anticipate a cash increase third foundation. quarter For the levels. expenses quarter have with our balance third to cash of And operating XXXX, in to million we strong continue modest we equivalents. from a financial and the We $XXX.X ended

Eric. I'll next this pay for and Importantly, well XXXX. into account extension the takes further nephropathy payments pegtibatinase as for IgA comments. achievements competitive both our quarter it for for monitors regulatory we milestone believe FSGS, into closing Investing sparsentan to of PDUFA sparsentan/pegtibatinase. expect This the as balance we our for to advancing the Eric date of over his now to the related dynamics back turn can support year, Thiola. first potential cash in operations into

Eric Dube

Chris. to date, the our review are for process we of CMA PDUFA and the confirmation approved first With well-positioned we you, become non-immunosuppressive the for U.S Europe. believe in IgA new Europe, nephropathy and ongoing in sparsentan treatment Thank

the study a sustainable year, of the look FSGS study in continued upcoming to pegtibatinase sparsentan become With next from our the program the teams more diligently experienced add enable a growth will the afforded us we commercial standard, if half the towards sparsentan of to be pivotal added to XXXX. parallel, affairs treatment the will U.S., in first medical advancement our to readout the and In time with as extension by and DUPLEX approved. even and working to in new

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

Operator

will you. Thank line take question from Mr. your line the is Instructions] Maurice [Operator the Raycroft first with Jefferies. We of Raycroft open.

Maurice Raycroft

recent examples And such you you as more my months, that that taking support would less frequent that? Starting update. evidence you've more REMS lastly, what question And learned Jula from about proposed if Thanks can mentioned. talk is. REMS do on about can for testing congrats you talk every talk three off, have plan the which the Hi. if about and your wondering

Eric Dube

Great of space. that. from over we've provide it the those and those and a you particularly what that I'll do Thank a that it you label. REMS, REMS nor Jula, learned REMS I'll Well, bit still is we proposed, the turn agreed certainly is What not Maurice. detail is I bit and for with submitted renal more Sure, question. to final REMS to with the have on designed turn other within Jula proposed would you have to on over remind detail to in that a do final questions. But provide FDA, we a yet everyone mind,

Jula Inrig

Maury. thanks, Yes,

our other nephrology So know are as levels goal monitoring the impact really our of nephrologists space convenient these And And a consistent is the there's practice didn't that this we regards REMS know within liver that's from the then how nephrologists tends X it I monitored monitoring within submitted of ultimately, our identify rare will like processes that different space quarterly injury. we with decrease which are the studies to that and some are has and back importantly of make transplant and and we number other paste and it done MMS the agents. analogues there's cases we're that's that education for liver And ESAs in to then a aware that their of within reminder, and important with that population patient Phase we also effective. over We of time. out familiar do of less point an number has monitoring, they're the been a utilization of that patience. monitor within concern slightly used there's monitoring, with we agents effective, trials. frequent any at of more was cadence of quite with another familiar to tolvaptan and

Operator

And our next Instructions] from we'll take of from Greg Bank [Operator question America. Harrison

open. Your line is

Greg Harrison

for our guys Hey, guys. questions. Hey, taking thanks

the on is, one First for the to sense [ph] you of view whether sulfonamide sparsentan? liver risk FDA's has do a have chemistry with anything do

Eric Dube

aware there. question. that we no, are So, looking make for that Greg, link thanks to not the any is And FDA of

We ago. are that this regard update aware X circulating some sparsentan about following our in of regulatory misinformation was weeks

in not group the making of anything has or Now risk this being interactions the liver sulfonamide structure raise, they of What chemical related aspects them is monitoring in really our our review the to important time during or mentioned need FDA related any in damage. did to NDA of decision. the liver two for however,

The what endothelin. the agents for the date. approval other And data risk this but do potential associated arose based liver it's ERA the rationale there injury under an of block the no within on much was on about is been that additional that damage diagnoses monitoring sort first hypothesis What a has for first of set to multifactorial, that ago has sulfonamide the liver sparsentan we not really clinical need with approval, been have hypothesis and the XX more now evolving is importantly, sparsentan-related know of out. really reported been proven that accelerated years the in is group. based an risk Most program whether class the was and with not

Greg Harrison

expect in requirements then any be follow-up U.S. you one change if assumption? helpful. will so, And ex to do monitoring And there timing geographies? could similar That's there liver is that any your Okay. be

Eric Dube

Sure.

label learned I'll we've have other have in at far. to So potential and well what Bill looked their thus monitoring, what we Europe as ask certainly for as agents cover

William Rote

Certainly, Eric.

recently in accepted application a for was marketing review. Our the EMA

EU engaged with point. reviewers with So at we active discussions haven't this

enzyme on know their potential monitoring elevations. liver we So don't for perspective

look They REMS. don't predominantly If at they the little a an take you education. in where they a really on -- different Europe, have tack process analog to slightly focus

interactions future we this able EMA. the will get more as the to with we So be assess in

Greg Harrison

Got it. Thanks questions. for taking the

Eric Dube

Greg. Thanks,

Operator

of the We line Securities. Schwartz SVB question ahead. from will take go next Please our Joseph from

Unidentified Analyst

for progress you This Great. this for questions quarter. today. Hi, on our Thank Congrats Will on the continued Joe. taking all. is

So REMS box changed start with warning, sparsentan bit. profile the I to the risk one us liver benefit guess of for for perceived the the expected has black view and some addition may a

at do of of have still you. be you the So also market Thank And expect launch? kind addressable assumptions your the demographic similar that changed? to addressable

Eric Dube

monitoring, the and I'd for Yes, bit great others not final And comment our addressable prepared has we remarks question, ask that based but that assumption approval. labeled not about mentioned will how on what upon understand he and that have caveat more Will. a we've believe liver population based it's potential by, opportunity of a need changed. this team seen to Peter do to our how that And are say on But I label, calculations in I'll little about his we Peter change. thinking the his not

Peter Heerma

Will question. So, thank you, the thanks Eric for and

it's think to rapid important treatment options. I population limited realize is with that progressing a this patient

unmet which for demonstrated high, need proteinuria remains reduce a to especially the a XX%. So that non-immunosuppressive nearly profile with is product has

As may the characterized most has out seen years, development. last few have called consistently as nephrologist desirable in research sparsentan over product that the you

was have their for context, made were patients think and monitoring uptake. So within liver that there it, commercial within it these REMS, in and I Jula products the if analogs convenient about successful physicians. there's good look talking that at the out And you

point is quarterly solutions And customized standard on [indiscernible] provide and progressing inform patient really it's a realize many monthly. base hub educational like. to believe become a even and that to logistical the experience also uptake the services these support additional often that that sparsentan labs the a the are our REMS what informing patient look remains because has have always take patient and And obtaining profile efforts foundational it to visits. REMS to So with and unchanged nephropathy good quite that we impact for implementation. But could practice importantly, will [indiscernible] and treatment some infrastructure further the have we in on may we may of most some patients potential ourselves script, the patients. IgA initial

Unidentified Analyst

I follow-up then And you. sneak in just Thank a Great. if could here. quick

of to there are for cadence of the the first uptake next thinking the And the days might about you. with are the gradual for overall Thank expect you Looking how launch, year? kind liver you year monitor? the early any analogs

Eric Dube

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

Peter Heerma

Yes.

mentioning I [indiscernible]. was think Jula

a XXXX, were in uptake. that's been -- in launched nephrology. think rare good analog benchmark in But us. has it's They for good I a successful a their think that's good I

Eric Dube

Yes. Peter's with that target to And I what's important reflects work think liver and team our revised is assumptions the refine monitoring. doing further is profile that research estimates through a market product

going take Peter can and more with. we to to just more So suggest we of in want to the focused on you will a bit on to be assuming it's but But And education mentioned, to begin slightly be we've to uptake or be successful long-term launch. that be the able in does a cautious been think, future, as gradual will could successful analogs. provide bit detail upfront, I that, lead out, we that that point it as

Operator

We will from with question go Please sir. next Barclays. take our Gould of Carter ahead, the line

Unidentified Analyst

requirement of that, about road. there's might the for database down to be a related for the if number you rough of been treated Wondering and data around And all sort provide This REMS years have estimate to this worth sort you on how Carter. is hurdle the congrats on Thanks question of patients revisit thinking Justin substantial patient a that the sparsentan. need with for have if can the with progress. of to taking

Eric Dube

question. to for you the Jula, will you. thank over And Justin, turn I Yes, that

Jula Inrig

say is have ASN publicly DUET. we Realize patient approval. we that long-term haven't that is amount going released can data the we upcoming accelerated We some years that I from present have. are this at that What under of to

before, released we've that how as data much of patients. have So we

accelerated under we the or don't analysis. set have approval, So data full

So are we those half on our have patients as sparsentan. on XXX trials, clinical we said, of

As to but we have of of before, time we've patients been sparsentan, some patients X,XXX period. exposure treatment and about who've earlier got those shorter were where duration said trials exposed

have for of mixed some may both a not duration. So longer them

be conversation and need So going time. will of going much of point what take? we present to -- is to continued over to to data second your That's how it a

exposure have complete we our when who And we and course, data. therapy both in approval, able we DUPLEX to have open-label will they gotten commercial read we be year, next complete get as year. Of will submit additional from out next to extension have additionally, that PROTECT these study, and trials assuming patients

will be conversation continued it a over So time.

Unidentified Analyst

you. Thank Awesome. Okay.

Eric Dube

Thanks, Justin.

Operator

We Tim will Lugo from from Please ahead, question next Blair. take William go our sir.

Tim Lugo

maybe impact therapy. of patients may then And sparsentan then program taking on maybe that question progress. for on franchise? therapies. become certain thinking the on for implemented certain see REMS a them discuss the the Thanks also that concomitant the REMS your what sale possibility or maybe are the value guess dampen REMS bit be I'm We could certain fragmentation congratulations is is I companies thoughts you and proprietary the maybe can for that different have for something a could patients groups. uptake cell

Eric Dube

Jula work shouldn't FDA Yes, Tim, a say, once on believe impact first, the anyway. full the or on And Jula of patients these is think to, practices. much are quarterly, is condition their I'll monthly aligns the that impact we assumptions impact And assess it design of question. I to thanks this rest of for will to we alluded what many REMS. over whether the the based question. and treated with the being that have how on uptake it our it's we date, have on as turn see with I'd be able the And for to very on final But the major or alignment we

Jula Inrig

Yes.

to and clarification a on how around Tim, Can monitor your Just toxicity? that get for they're was to clarify, going embryofetal I question subgroup?

Tim Lugo

different fragmentation on mean, and I'm FDA Yes. I subgroups And just versus certain monitoring guess, concerns, broader you versus that if monitoring? others. include sure. maybe monitoring how thinking could alleviate of sort I any

Jula Inrig

going that and to reproductive confirm to me a done all embryofetal patients is toxicity, have everyone's to let sign potential. for clarify up their Well, is this for thing that consistent

cannot you have every single up the participant around what and because education simple, a upfront there's pregnant, ERA across when And that pretty it. be. can they potential confirm that is prescription. become they will who So attest a class. to going sign testing to monthly this and people class, their get reproductive to done And pregnancy for that's there's and It's then a cross is document

Tim Lugo

Okay. All you. right. Thank

Operator

our the ISI. take Please line ahead, of ma'am. will Evercore next Liisa from Bayko go question We from

Liisa Bayko

Could think think that? you Do you concerns? question. of perspective. point. Hi that's there. eGFR do some about final going The -- file then And think Thanks Do to you taking you was with have for FDA? to my address for at final your prepared? might timing the end the be you data? it's yes, talk data you start will When When

Eric Dube

Okay. hear. little It bit to Thanks, was a Liisa. difficult

me let timing from the as confirmation the FDA. the of as trials questions are well expectations that you're confirm, eGFR data, final from right? what our our Is asking addressing So for about data those including of any just

Liisa Bayko

Yes.

Sorry, I'm on plane and a [indiscernible].

Eric Dube

you Well, okay. joining all thank That's for right. That's the call.

any in think So, sNDA safety both to half in-house, or certainly we DUPLEX we the in also half get nephropathy of window. available the to as in tighter the we data those of assess those full final of guided available But adjustment monitoring approval assessing IgA that final then a will next I yes, track first X-year to the And to as data from FSGS, the or diligently we've be the track data And for of we but for in for the perhaps year the sets, part liver are and for throughout on work data refine delivery year. FDA, approval from will removal we PROTECT of the are able REMS. an the closer further potential for package second full the next for bringing to will timing be data submission as will on sets be year. as

So I the see be think point, this conversations year. the intent data make those and kind we that's next further to for assessment certainly further I think will of once agency. our able at and But have plan with we

Liisa Bayko

you can size duration the And database? us remind of and the on

Eric Dube

over be to the terms that in of turn and I'll data will that And also Jula part size what submission. Sure. of

Jula Inrig

Yes, certainly.

randomized to got who versus patients active XXX about have sparsentan. treatment we that recall DUPLEX, for So

sparsentan over So to patients we that. are have will complete trial. X-year eligible the active to with they roll realize And once treatment that

rolled So have additional will have data. patients who we through over

got For PROTECT similar roll design got that sparsentan to control. patients versus who again, have patients about who the will trial, irbesartan XXX we study over. randomized then And the active

So where we active those exposure to in additional have over open-label extensions will patients treatment. roll

got So in different for doses. exposed which patients some additionally, up we XXX now have And of studies. but have has exposure on patients, in now. we then DUET duration significant we And early almost have totality, early patients. the of hypertension, patients where the in of treatment been have shorter And about roughly days about to who XXX X really who those patients, study, we had to again, years

Liisa Bayko

lever other have out other what you And look at seeing that presented of companies size duration filed there packages -- of you testing Great. data to when move, that -- get the there? are what was

Eric Dube

is that know because this of particularly difficult FDA division instance, within It's accelerated H lens we looking to through say, I it the Subpart Yes. approval. the and cardiorenal think,

number patients. we to particular are with diseases within of or heard particularly set evolving an really the regard It's threshold on studying. So based we anything data a that haven't

submitted find the as this remind if But will do find further I just a for aspect we've certainly those the kind that think approval. is other tried So you, the insights, were -- others would to in do share is Liisa, disease and that non-rare were I we we this rare full way. of think along and I

a it's set unique provide navigate finished data continue when situation will they a to we are with certainly more complete next year. think I much and FDA So that we

Liisa Bayko

you so much. Thank

Eric Dube

you. Thank

Operator

of We ma'am. Wedbush go will Please Securities. Chico line take from ahead, question the from Laura next our

Laura Chico

earlier the this afternoon. to I Jula, for correctly. on think I comment, wanted Good follow-up I one taking -- question. Thanks hear didn't apologize if I I heard that

is is comparable to sparsentan? in wondering, I magnitude respect sure I if instance think increase? that single comparable studies. that's it quick is elevations, If irbesartan the follow-up. terms low I And ALT/AST of elevations both not correctly, think, of then or have with the are terms it digits. you showing recall to of rates in were but of said I'm rates sparsentan correct, in ALT/AST one irbesartan of Or the I

Jula Inrig

and we we've two event that our adverse rates what increases elevations, regards similar So And of to the events for our that we that monitoring. And collected DSMB submitted was was that's of also prospectively of interest. monitored Xx which adverse between because pre-specified to with comparable. interest the and AST/ALT released arms

Laura Chico

it. Got

FSGS Okay. IgAN has much. patients? I Or this can the you've setting? if far very Thanks been so in apologize the And elevations sparsentan then you observed confirm you disclosed have not dosed but with this, with

Jula Inrig

Across the trials.

looked totality. we've it at So in

Laura Chico

Thanks. it. Got

Operator

Arce last will go question sir. Wainwright. our Please take Ed We from ahead, from H.C.

Ed Arce

and taking from couple in progress the questions congrats for Great. on quarter. A of questions Thanks the my me.

REMS. on just wanted call the regard of to today the I monitoring sort confirm the with liver Firstly, share here some in to perspective

to As think fresh that the weeks the you now you you a over haven't some look had you taken and don't impression. at your gradual said uptake history And others is, today, last really, a analogs you've mentioned I ago, couple as said, is expect of had of utilization I and second a ultimately. Question there. impact mentioned any couple earlier weeks you think more

gradual So I remains I on a of although the focused that little uptake? that part have clarify more could to And just initial that have the sort really term more wanted a then unchanged you're uptake follow-up. longer

Eric Dube

recognize the the education sign that sparsentan need. this patients change for does clinical population we clinicians up and that some practices additional and does just that nephrology as change assessment it nor REMS of having We correct the monitoring will that addressable of well the initially. made. Thank you, Ed, do But for we've need unmet profile a liver question, or as and not require believe is the

the that impact and launched have And we to completed have contemporaneous long-term, guidance market is to view a others that and do is be to an any make we certainly, that's we mentioned sure so assumptions the previously, will that, assumptions. But short issue, successfully provide we not that, believe REMS. term. to we what have that refine once research from have we've continue who going And believe as with gleaned those launch of going we've our really

Ed Arce

the be Thanks considering you barriers as are is successful study cohort pivotal in that? endpoint? just any that. the And accepting that Understood. turning fixed then does And play that this primary before role what FDA And in Okay. regard, pegtibatinase, in confidence that homocysteine what you. to secondly, that? gives ultimately COMPOSE would total you securing for Thank data from

Eric Dube

community a is Yes, for is has need. I we unmet that as certainly which that's awareness And high really thank on October, that Particularly about one a recognize month, believe that our you out facilitate we of driven pegtibatinase, next a closed be it's to ask homocystinuria a think for. entail FDA the bit might looking Bill Bill? to biomarker have talk desire phase we what what will endpoint, which that little development. may and I'll question.

William Rote

through completed gone view total utilization believe overall having agreement received -- specifics in a therapy But homocysteine on of pivotal or utilize discussing is of the We've homocysteine as it endpoint. Phase a trial, an there. big the breakthrough that important we that picture gotten as that working the reduction, threshold with the haven't design that and a the endpoint primary From total trial. using X Certainly. of agency -- the work we're with and of several We percent are interactions the and still detail the how you an we've is agency a endpoint designation. as trial is what

end under subsequent coming the are little up a meeting of breakthrough. and the multidisciplinary a have interactions easier have We bit then before to year

to look those So forward discussions. we having

asked testing higher You is dose cohort. sixth lyophilized a as about well the a formulation. That as also

in data earlier. final and the So to confirm in the formulation safety tolerability see make the to formulation liquid a to opposed and need to the selection order dose we to lyophilize as was that

path Phase design. gating trial around discussions further it's to X, but on it's the So not to

Ed Arce

much. That’s helpful. Thanks Great. so

Eric Dube

Thank Ed. you,

Operator

today's concludes back Ms. Eichenbaum I the session. conference remarks. closing additional will That for At or time, any to this question-and-answer turn

Naomi Eichenbaum

us afternoon about learn you, Thank to Great. everyone this for Travere joining updates. recent

exciting updates to way. and great a have sharing milestones the rest We forward of your along day. more look Bye-bye. ahead Have

Operator

today's your Thank now and for That concludes participation, you you disconnect. conference. may

Travere Therapeutics (TVTX) 28 Oct 222022 Q3 Earnings call transcript