TVTX - Earnings call transcript Q2 2022 | Travere Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and welcome to the Travere Therapeutics Second Quarter Financial Results and Corporate Update. Today's conference is being recorded. At this time, I would like to turn the conference over to the CFO, Chris Cline. Please go ahead, sir. Thank you.

Chris Cline

Caroline. you, Thank welcome Results and Therapeutics Quarter Second Good Corporate to Update Financial and Call. XXXX morning, Travere Thank you all for joining us. Today's our call Chief by Executive Officer, will Dr. be led Eric Dube. prepared Eric by for be the will Dr. joined remarks and Chief Medical Clague. Heerma, Commercial Officer, Jula Inrig, our Officer; Financial our Chief our Peter Chief Officer; Laura 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 now X, future statements events the reflect August of that, are With over any made, views date XXXX, our addition, to only turn statements specifically to update the such disclaims information, obligation such Eric. any I'll call to circumstances. Travere as represent Eric?

Eric Dube

and programs, is where which afternoon, Thank we begin. on pegtibatinase and provided good Yesterday Chris, morning, everyone. update I you, sparsentan a comprehensive our regulatory will

This this meeting potential that sparsentan our action the that review target track a IgA in approval First, November our the on us confidence remains we path for nephropathy sparsentan for of the process for NDA date our on FDA communicated recently later of IgA to XX. review year. mid-cycle the are in nephropathy to strengthens PDUFA

to of continuing are made am and I progress launch pleased sparsentan, such, the As first we our with efforts have the date. for very ready the organization to we

accelerated FDA our potential to update second the final FSGS and Type with interactions for is approval discuss for The planned of we the A the that sparsentan minutes. received we completed meeting

than has pursue for slope approval on DUPLEX rather a completion FDA X-year submitting accelerated that year, we interaction, year. the following next the the this Following of data collaborative study traditional approval eGFR based recommended

disappointing will does it change that for sparsentan our nephropathy, for FSGS accelerated as year, While the become treatment IgA we be this not that not approval a in standard filing not has is if potential well sharing important with to as it new align ongoing us note, assure should did the elements few disclose FDA they stakeholders. the that integrity, Of approved. a on data order reiterated with study while from again we to detailed trial belief

are the to first date provide as deliver the well the challenges insight to controlled into to to its FDA respects, many this few heterogeneity. in There clinical we data recognizes and a FSGS, way, disease. trials need largest the our unmet completed is leading that date significant DUPLEX study In studying the given is been the field. as track have The in set on

confidence to with is enable acting will study DUPLEX based approval that recommends eGFR pending that we potential important third study traditional from consistent the for second and we the that X-year sparsentan. the And to are pursue approval of that support know we of the slope. continued DUPLEX as fact interim FSGS. of in to we XXXX, on submission for that The FDA the is matter of data with a approval has the have that DUPLEX maintains And support pursue the study. the in in first the that development These was us sparsentan ultimately as FDA what history they is since the consistent point reported completion designed, study the indicated profile points eGFR analysis have a February progress the the full its

half the to in the year. eGFR data of additional have expect and available slope X-year We next first

Assuming completion of that will to supplemental of IgA the for next partners or the next second for end on sparsentan abroad particularly see in in achievement year. is program approved exciting and to granted With for the we for to we be the step and year. from nephropathy, the U.S. a is NDA this update an FDA submit position sNDA and a in the pegtibatinase clinical results and Vifor as our half U.S., FSGS by in supportive to we X-year of establish our at this have pivotal meaningful on our FSGS authorization DUPLEX, work provided update study for activity. pathway data marketing IgA for an Jula yesterday the and and disease. from joint to DUPLEX full bit designation its a last program, over approval regulatory from for a we for HCU. a Pending Jula? forward breakthrough we has Pharma for in targeting the The and the own for study, more Europe for approval that Europe This application was we afternoon both I will nephropathy turn this pivoted sparsentan nephropathy biomarker now conditional indication updates IgA call therapy devastating submission of year. in apply the are supportive

Jula Inrig

the good for FSGS. morning, by begin need and with significant nephropathy everyone. non-immunosuppressive living I'd people Thank recognizing and like new to for IgA Eric, treatments you,

safety from that hear community are to concerns. profile continue have the from challenging effectiveness, options nephrology in their available patients have effect limited and treatment side a the We or long-term

progressing patients are many to end-stage As a kidney disease. rapidly left result,

interaction, nephropathy our that FDA recently we for was with and and treatment, that were this I granted indicated for the the completed mid-cycle IgA will proud use we greatest the NDA to their review they pleased We sustained not evolution an looking sparsentan paradigm our on In our that date the review approved. to IgA be for chance assigned meeting. committee nephropathy FSGS quarter. reiterated nephropathy promise the and FDA the to of first team's the continue the pleased in planning this Furthermore, sparsentan see looking our to nephrologists November over hear modalities action reduction believe and alongside discuss program, We IgA execution also of are process believe in potential other foundational application. the provide as will proteinuria advisory and physicians of outcome priority XXXX, treatment FSGS. of treatment a be remains are by that am accepted target PDUFA review. for In therapy the time. XX, for with future foundational track to patients become were of that they second We the non-immunosuppressive the indicated if to

on-site PROTECT clinical practice very with sponsored study. inspection. our the We have have also pleased or met high-quality standard that throughout successfully teams I'm operational good GCP and the our completed clinical

nephrology in foundational believe As education strong sparsentan we we continue moving for point team to become November. action are new nephropathy we've education we In know state months, strong target engagement. a effectively to that medical standard. such, broadly a is as medical the towards in enabling seeing treatment a more position We date disease the and to we're community, the X expanded IgA deliver last our

into provide patient the best that able develop groups work disease to important in education insights patient patients' field. us closely will this the and collaboration, nephrology the advocacy state Through help incredible with meet continue journey we to Additionally, we're needs.

received recently FSGS. on our clear path also for definition We forward

not it's to where our go into some FSGS but first accelerated sparsentan earlier, FDA Eric DUPLEX in important that data one a of for but eGFR we're has indication As accelerated details study the in I'll of approval the of recommended sparsentan, following mentioned why the receipt traditional approval highlight FDA interaction, approval. of pursuing rather and from pursue we X-year supports another. situation the than

we is to paving is of would data accelerated study. know, challenging patient and the As with more FSGS, study nephropathy. population a in requiring degree we're limited high for DUPLEX in than with believe first the IgA approval, In way high. assurance FSGS that's the for a the essence, FDA set a heterogenous We bar be which

between design we historically have and the that DUPLEX also studies about talked PROTECT to differences consider. We are important have as

period did in change initial received it drug. of a medications to and patients you study DUPLEX of recall, different larger run-in ACE/ARB tolerated will before max many or a eGFR inhibition speaking RAS specifically washout As background a DUPLEX Without X-week on period. had expect not washout PROTECT with require a would one and

to important note. is this So

that background We is there II RAS and and also had uniform effect difference initial about total expect inhibition the eGFR a difference ETAs on which run-in we initial established think last you clinically have with when in starts on measurement blockade no proteinuria This baseline assessment know an In larger the sparsentan float, you'd washout February, of to the reduction. with over from to the overcome in our interim EGFR and means endothelin experience at other with DUET above a meaningful alone. Phase history study already medication.

years. type goal for planned patients the we least meeting threshold a all statistical In for less pulled eGFR So any our cut patients were nature. have to which study, we the accelerated agency, descriptive of the the the did A met data do when shared purely mature from additional data eGFR and was data analysis that point at alpha In of meeting year in limited study for half taken been observed X the if and see provide of was The in more was slightly a the data with data. study, X the preserve had FDA's order than to that DUPLEX eGFR approval. at been the in on not

reported progress the profile highlighted with study Eric a manner eGFR This DUPLEX February have was is sparsentan. and the and expected encouraging of data analysis continued the since the last in consistent to to As year, us. interim earlier, in that

approval However, their limited last do an application interim together indicated accelerated data to the meet the year, with analysis threshold eGFR support for conducted in not additional FSGS. the FDA that recent

as to on the the support we full X-year pursue approval they and meeting that DUPLEX Importantly, study, eGFR slope. designed, completion minutes potential in FDA the that approval the maintains the recommended and study reflected of based traditional pending noted the

expect half year. assuming sNDA position nephropathy approved of for to the We submit a second to first in a those next in data to half be IgA the and in-house and next of in sparsentan have year, is

with closely to working we Finally, regulatory partner are the our our Europe. and on U.S. Vifor for align strategies sparsentan, Pharma

marketing in IgA Following next half end potentially a and and the We anticipate by second we're the applying pending FSGS year. FSGS sparsentan of FDA, decision of the in update submission review for data of Europe. a in supportive subsequent for the from potential conditional nephropathy authorization DUPLEX completion XXXX

to patients people breakthrough approach for to Our pegtibatinase the and all is the designation a options a received commitment significant designation our enable activities designed open-label In total breakthrough Study. EMA to for X designation aspects date pivotal by data potential in generated the living parallel, This X.X in very on alignment the FDA, endpoint. FDA program. with coming to pleased the organizational has for a gain From complete and the to on approvable with enrollment the therapy homocystinuria recently program the meeting in to multidisciplinary been forward continues to COMPOSE high the the construct continues continuing of we pivotal we with as recognizes COMPOSE of that look I'm that homocystine promising progress This to we continue progress, new In the and highest we extension need to utilizing study to there, from success, additional expect with and we're FDA. kilogram from biomarker cohort. us treatment dose with and make per our progress. discussions engage for an the study afforded aiming milligrams as months, on

for through of constraints phase to We to development commercial access. ultimate pegtibatinase's also manufacturing CMC the and and on continue global focus ongoing working scale pivotal supply

Let call commercial over now the Peter? me Peter turn update. for the to

Peter Heerma

with I second Jula. you, pleased Thank commercial organization's the the quarter. am execution during

year. this with strong launch have and our for for approved nephropathy sparsentan with progress, the to both a products We make potential IgA preparation of later continued

During for dynamics we seeing year, Thiola, earlier we about quarter, affecting saw strong demand this have talked we but the second impact of net as the sales. are generic

balance always to continue team easily how We rare in bile treat is patients we expect and with to of a homocystinuria the acid the there will bile not of pressure pleased continues community. quarter by are the patients during the portfolio well I'm as of team's performed very year. expect demand half the identified evolves, the that diseases the market in another example growth second identify with be of portfolio Cholbam Supporting competition to continued year, or and identify, led great our acid ability our Cholbam through understood. support The but for downward

delivered XX% organization, the to months for growth been well that years, loss, rare is within necessary historically consistently able commercial X Our diseases. was utilization services first than achieve X organic of it formulation support has year-over-year the more provide with able patients of to consecutive to new

We approval are strengths, of are to these potential be great and a building year. making for ready upon we sparsentan this strides

almost I to field of strong organization, of achieve note belief if our the XX the we that approved. of support alignment clinical our FSGS foundational patients and they I experience. IgA report [indiscernible] all to will pleased very have specialty of team is treatment uniform an making believe an they recently that and therapy for and tell to pleased we and am experience about years as As vision have engagements. world-class just support in that be the I it's provide managers IgA a a sparsentan standard. of nephropathy for Team the approved. and also IgA that potential the payer ability nephrology at expressed through recruitment may the if approved, average approved. sparsentan with if that and our can force account has with I'm that nearly sparsentan have nephropathy not become for to patients, launch, new great research increasing in team the product we if of team the often, field parallel that nephropathy is are field, members opportunity of preparing kickoff has to you launch understanding infrastructure there markets involved in excitement We to our that full the had the sparsentan and meeting get to completed In

a with driven also get be eGFR gram the day. can X gram day their and better by then patients key there nephrologists that treatment to do needed, meaningfully earlier, with This sparsentan that disease would X above for for for As IgA that hearing per have nephropathy that proteinuria effects the in proteinuria, adds sparsentan Research a are patient and we increasing a use urgency the survival. is per resonate belief below the for a there engagements largely who if reduce Notably, not is combination what of potential treatment from need their steroid proteinuria, profile our nephropathy minimization belief there and which that to combination of physician for significant immunosuppression. suggests as patients clinical IgA the profile leaders, an remains treat from long-term goal nephropathy thought allow they top nephrologists, with the in like the and their will benefit consistent renal our options are on with research Jula that highlighted is reduction to nephropathy, and other continues of results if are long-term new foundational use. to optimize and potentially confidence product reduce chance payer proteinuria to patients options, IgA supports progression. treating The stabilize parameter

to profile we the how in IgA is The reductions engagements. proteinuria combined if sparsentan ARBs. when a resonating pleased especially There introduced in with strong nephropathy is a such proposition as value understanding value comparable Additionally, of utility our before and standards nephropathy, in are the current they potential significant disease. with of of inhibitors progressional proposition in safety meaningful ACE clinically increases IgA are treatment payer

at the We our expanded learnings over for vision strong a in to also to to from us nephropathy internal potential launches ensure and patients apply making feedback best be and believe -- us IgA a for recently from now sparsentan we incredibly with on update. allow financial strength will these from and team, positioned will time IgA product to if launch foundational of we together XXXX, patients are call now launch. approved. of the focused that enable nephrologists commercial have strong nephropathy, in the IgA turn Laura? between with the patients achieve perspective, Laura Lastly, therapy FSGS the I the our approved. experiences a payers sparsentan will nephropathy already the supply Overall, availability external to for for if start launch for and X

Laura Clague

you, Thank Peter.

For $XX.X Vifor to compares we Pharma. second total product the in XXXX. period of from net in revenue million, in XXXX, reported with million quarter the million of sales $XX.X same of approximately collaboration and $XX our consisting $X.X net European revenue product reported for million sales This in collaboration

quarter is second as adjusted increase it On quarter-to-quarter, continue the basis, $X.X noncash advancement that consisted an Consistent sales. following and second to adjusted quarter of GAAP we an a insurance the to depreciation The in the quarter million second year, we commercial $XX.X amortization. loss XXXX of noncash quarter, changes expenses loss for reported a expenses from compensation basis, $XX for to operating continued typically the from amortization. stock-based largely headcount well $XX.X to and basis, $XX.X nephropathy. adjusting the million our second our affairs narrowed for R&D gross programs. million the net On quarter were reported net an to to net second of headcount anticipate second The in planning attributable million. second will quarter quarter levels, the increased and income for impact for of On prepare see we attributable increase GAAP supply largely the adjustments XXXX. As for the the sparsentan Relevant SG&A to for coverage of to in XXXX. selling, is be $XX launch a and as as pegtibatinase of typically were of with tax, of expenses XXXX. IgA both basis, first million compared activities We and support sparsentan staff the $XX.X On of expenses the non-GAAP From million expenses for continue After of that quarter Significant beginning R&D sparsentan noncash a quarter the we increased of for general expenses invest million as included for expect GAAP and expenses XXXX and stock-based fourth compensation discounts were expense in XXXX. and increase XXXX from quarter long-term launch compared of administrative second in pegtibatinase. current potential now and and preparation. $XX.X XXXX force perspective, levels, quarter uneven we may for were SG&A million. clinical the increases work we the field have full ongoing R&D and medical the

As with quarter half we made NDA payments nephropathy. onetime payment year, the We in to Ligand in be to financial milestone the strong we quarter execute. $XXX.X the position submission second the Notable enter during million IgA consisted for continue $X equivalents. an cash and cash of ended second million the of for to a second

support believe to launches pressure to operations FSGS account Importantly, XXXX, pegtibatinase. related into further achievements nephropathy this cash regulatory our for balance investing milestone IgA we sparsentan in as and sparsentan can expect competitive which for payments pay as both we well potential takes Thiola, and on into

bright, the all years. next to remains you our rest continued as incredible Travere and support a for finance I to of to early and smooth last year at transition. closely this and I'd with working Chris ensure will X last team like and through incredibly team your of the forward engagement As look thank future management The my the CFO, over be call

comments. the hand for Eric closing over now to call me Eric? Let back his

Eric Dube

to the of you, rare Laura. being vision a disease our execute leader community. towards in continue global Overall, Thank we

medications this with access doing strengthening of organization sustainable needs growth continued available. broad We for of for products the pipeline to support the development are patients the of through and to it meet objective our to by become years positioning as our And come. our diversified our

use. review new the we in second confidence launch of sparsentan of IgA that nephropathy the a that be organization, fully having November, progress and track, not for entering come in will difference for are changed. is our goal We significant have We and we made to has ready wait shape time, now becoming for rare believe bit process a year, a sparsentan but we kidney will on matter approved. the longer in will treatment NDA half remains put to our disorders. preparing We fundamental know FSGS, and standard for The the it are good we if towards of value our and great to

nephropathy, of if the results of awaiting the on are learnings FSGS sharply the of data will eGFR and we the applying more focus take full those DUPLEX, While launch IgA approved. the even to to from X-year approved, opportunity in we commercialization if future,

treatments. of on X designation the bright potential new to leadership and I service to balance Laura Additionally, through incredible also now what program the execution need that is be The pegtibatinase, to and of would we for reiterate in year. you to the delivering of she a final align breakthrough in to therapy chance best I future for with pivotal look the continued incredibly earlier. will said like success thank Travere, forward efficiently at believe we and extend able a us community her regulators first granted disease-modifying with give therapy will

over turn Q&A. for me the call Chris let Now to

Chris Cline

Thanks, Caroline. ahead please lines Q&A? Can for Eric. we up and the open go

Operator

William [Operator line Blair. from will question the Tim We Instructions] go take Lugo the first from

Tim Lugo

of on the look FDA be you your believe to on preserve I But patients alpha, was the patient bit Can for approval, mentioned had be you on wanted you all the now run able -- X I in a you're to X-year bolus clear, the will with a initial wanted years. I Laura Congratulations post proteinuria. what progressed to IgAN about years. to therapy? have -- guess, and over at? expecting the stats sparsentan, market. hopefully, to And know from expecting to data do work already half at launch just you over who bit I patients talk Also, you past obviously just the those little are verify that start DUPLEX not the therapy I on predefined steroid these already

Eric Dube

thanks And the early was how about what ask then approved. data on for to take I'll the thinking I'll we're of ask questions. Peter the available -- uptake in first about talk for IgAN Tim, Bill question FDA. to once

William Rote

thanks for EGFR -- agency, with Tim, was there the our question. very the was to the done agreement and the With a preserve strategy alpha for little with deliberate data, the that study.

So what the we provided was the the all available for a descriptive arm and composite sparsentan treatment look of at irbesartan arm. eGFR data

broken So but that at out you, looked on years and it it wasn't It based that data year. combined at versus were were based those those wasn't with into of groups they if on together, the was specifically helps study. plan, duration divided in the at eGFR X that specific aggregate X that

Tim Lugo

Okay. That's helpful.

Peter Heerma

additional Your build? question we -- -- question have an for the your shall your bolus to can so question on answer I

Tim Lugo

initial of hear for other the hoping I to term be that bolus or the Peter, No, What they steroid? you, do on of failing budesonide kind will expect patients. was long versus you

Peter Heerma

are to introductions seen challenges. obtain for want with don't their in that like that, the one we that Excellent. in about the elements it recent nature a are for nephrology. Tim. them they example, Thanks prescriber is taking relative their office treatment base new of And that of know, adaptation patients we to into uptake, as or nephrologists Thinking We initial consideration. have for there conservative several burden

planning we for, experience we something that's and that. are have that to So the navigate

anticipate sparsentan during are first quarter first holiday we in also that usual the expected well. full require XXXX. as will in certain of payers as and the that's the is the So resetting plan. when season, And the we quarter In see launching that insurance for challenges

are a once those patient their make we gain consideration. a physicians take strong anticipate therapy foundational into experience elements patients. So do for it and We uptake

the other achieve profile together therapy, believe with team as and reachable. resonates mission sparsentan feasible that that you're in talented I to launch, particular, with a the needs with a patient that later So but we But our me sparsentan. confidence think talking seen not about, on faster gives our our be timing think think I experienced and bonus well have experienced a attractive foundational the given given with commercial is as have we nephrology, what sparsentan in may once updates that of of usual update physicians and I

Operator

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

Maurice Raycroft

for as morning. means? mentioned good well Thanks had great on my the is continue FSGS Laura quantified working what elaborate and FSGS congrats high. FDA my And you with what question the approval? threshold you, you the you question for taking consistently. Hi, is lastly, mentioned to for is a Has And Can I you. sparsentan to that you bar see

Eric Dube

what Sure. first, understand turn articulate to I'll Maury, is to that Bill, I'd say, approval we bar for accelerated with FSGS.

see ask between sparsentan profile design to question, her as these highlight your link the what throughout Jula that and the historically saying to perspective differences regard Bill first proteinuria with link the X trial around eGFR. as modeling the the literature consistently we I think that Bill? ask programs. on to that and take I'll well between I'll programs we've and it's important that of the to really been us for then supports provide disease,

William Rote

for hasn't a been bar very in disease. existing also, difficulty Yes, enumerated They that certainly. additional in that data studying threshold, The be There have they've few do a Jula numerical with FDA us. some really we done the will study going discussions year, an FSGS high. in is this once believe set in recognized in specific controlled it a is to isn't early in to DUPLEX color. FSGS them, the have There and our studies largest set particular. specific but precedent that, I we over but hand next complete to threshold we of have the don't

Jula Inrig

protecting DUPLEX have sparsentan the FSGS, acting patients us the with Maury, saw historical DUPLEX profile, unfortunately, we and saw in and The nephropathy is FSGS. reduction with in reduction in you, I'll what's refer back but Obviously, seen the we regards ongoing we've is saw heard the with the IgA referring across patients we're to with in trial. those we consistent the that date, the to consistently. what PROTECT Yes. of consistently proteinuria DUET. data release any in patients in consistent the proteinuria comment the as proteinuria eGFR trial they're to reduction consistency that in can to data, reassuring the DUET is that can't that And all integrity trials to of we trials, we

see acting DUET, expect we with we of able sparsentan historically we that's And the GFR. stabilization with consistent would consistency of see RAS and we're an see, history we what that and as to is profile EGFR with and that's saw in we've sparsentan and see. historically. blockade. that that's of sparsentan what you the a say that's then decline action with the of And we what natural us endothelin acute only gives what the mechanism and And And you to dual so that anticipate saw would to what combination see that the in seen

Maurice Raycroft

really That's quick X Got maybe follow-up. helpful. it. And

of on they Or Just and control they magnitude more focused what the the treatment. are digging for Are into more on treatment? focused FDA's between the you duration see threshold. of delta

to the X-year And want FSGS? so see for that's data why they

Eric Dube

Bill, it you. to I'll turn

William Rote

Yes.

I it's things. those all think of

effect end, a accelerated of on study, anchor go it's across partial recall they it's a it's available. that presented being data it's data all have by looking X so element. set of think proteinuria And of data specific effect, a duration the I picture approval, variability, the on, only all then the the X elements to with that size, but not it's but strong it's less a of consistency that's

Eric Dube

your thank Maury, And yes, I for question. -- you think

think allow us years, completing I in sNDA with that to to X for the important year. meet believe we ultimately, bar that's that it's that reiterate going time full to that next approval

Operator

will next Securities. question take We the line SVB our Joseph from from

Joseph Schwartz

wondering be some talk these best patients? And was early to and heterogeneity sparsentan, Thanks approved? you are in representative segments And any DUPLEX? great was FSGS the to to of also pass are of the could present along in of very I it contracts the much have would like you. particular the population I'd themselves? if there patients these with the little some of adopters versus market a enrolled that later that more Laura, work expected of been be if about naturally to How my wishes overall bit guys

Eric Dube

the will looks ultimately X for launch little Joe, then bit the you questions. patient we thanks population the thinking can and maybe to like. what the Jula? that to look turn as Peter I Jula, share and a of

Jula Inrig

Yes.

to note. this And population, is mean, is I that's and and a FSGS with FSGS enrolled wide above a primary enrolled spectrum I So the trial with of patient of date. we largest range to FSGS way important the And from patients XX% patients progression. patients for risk a we FSGS eGFR in heterogeneous spectrum FSGS XX. eGFR with and of genetic XX with with patients included of patients wide patients the And think at above XX,

significant And proportion So we state as additionally, the their to really we're think regards represented. with enrolled disease risk patients. a important I at that And population high earlier patient for well of to that's with note pediatric in still regards to but progression. eGFR,

I'll range here. patients it well. that's who thing so I a wide and note of important then significantly think to over with for turn And be we Peter regards to to at as we're just And think going to progression, risk an studying

Peter Heerma

maybe other we see in nephropathy, excellence, concentration rare of for And as as of well diseases prescriber segmentation our finished have that mean question. are more we physicians. what treating Joe. broader we care Thanks other care a Thanks, that behavioral is have more for I nephrology. central patients aspects. at you In potential in and where there both looking IgA are Yes. amount than

we have about seen well. I the at as by But still, historically look nephrologist. -- that when we different we see something in talked is patients amount think there are of it's deciles, the differences

we is our think have physicians on that, to well, be good efforts going on well certain our allows I a to how with as for that orders. focus that initially very handle focused launch we focus us and as and centers be

Joseph Schwartz

very It's helpful.

Eric Dube

context I as be for that space, important it Joe, Maybe because for bit your close may to a little not think will reiterate. to add I can more just folks questions, this be

and belief from FSGS a sparsentan injury is to strong uptake. think, that across is, population. are on broad the with based there's hearing first we regard action there mechanism market use of heterogeneous What of of amongst The the nephrologists nephrologists that would mechanism pathway, and common I that the unit be action

don't see so we pull that X to way And of that segment. there's particular with any kind or another regard

and the And therapy in where Maybe, about context of patients what spend about just may and both to think the eGFR they typically bit DUPLEX mentioned that and -- So a for that that pediatric speak we the in patients today little trial. heterogeneity IgA perhaps and to want with foundational contribute assumption to see our the we nephropathy. Jula, why will we profile a FSGS that of FSGS in a Jula view do I moment important the why the you on behind in fundamental can that's that sort are believe pediatric it's trial. be sparsentan

Jula Inrig

that give high to Yes, spectrum patients trial, in early and and the have And you normal very patients XXX. above the endothelin the that disease think are really pediatric when range really normal, we within do RAS represented patients, this in well kidney what correct antagonist FSGS, blockade. of did certainly. it's really want we broad you who down to that's we you functioning about or whether an pathophysiology of their When have in function, of

correct. with distinct to to correct say, injuries common you And that's want that's IgA the so And one of that you hyperfiltration. And FSGS nephropathy. that want pathway from,

Operator

Bank We will of Greg question America. Harrison take the from from next

Unidentified Analyst

calling [Hao] Greg This morning. Harrison. in is for Good

had the Just determining So maybe have sense IgA of factors starting of to value? the process with question some a thought maybe benefit of balance too nephropathy, when pricing. the you kind you about about about and I patient consider get a just your would pricing that sort

Eric Dube

Hao, Yes. the for Thank question. you,

I disclosed the for not thinking pricing be and will we bit prepare pricing to launch yet, Peter team's as of will his we have but specifically ask a We nephropathy. share how in IgA

Peter Heerma

Hao that for you thank and question. Indeed

of community. renal So yes, burden yet. associated given quite to the end-stage value patients, for price substantial, know nephropathy IgA disease, payers launch cost studied have this any pricing it bit studying ultimately is the won't those make well, like what disease as some that that's we the well, insight could of proposition disease the of value we earlier been have today. in to seen disclosed data we started have payers We with boards advisory that reducing have proteinuria with potential with of And for and engaging that conversations. amongst field be could in on level good payer And sparsentan, a to see as the we sparsentan. disease the often have we on we leading but nature also as and well with very of there of of that to protenuria what what many as a proposition there's mentioned, well understanding understanding sole needing a disclosed be. for Eric not pleased I'm the the is sparsentan of And as the progressive dialysis. And We've do value

to is price. provides the potential on count. answering I pleased and on product always starts and question society, value So But that. than payers me think price, this it your to like that something It's having we're the I'm conversations what the That's not with that with confidence. gives rather

Eric Dube

-- new will is access Peter. we -- to do to I foundational you, our given be I strategy make our plan -- What sparsentan sparsentan additionally, say, that think price Thank the Yes. how broad therapy. can for

insight to and think And vision achieve And the for with our access. access from And be a a sparsentan. for early to of within that we the great are lot this health have in position make and us we'll need we so in economic modeling we achieve benefit doing that uptake others vision, broad well as on to Peter's work payers the space. team taking is as I very that order sure strong

Operator

from We line Barclays. Carter will from question take the our Gould next

Carter Gould

then here? stats to that would perform discussion Great, a through on some morning. helpful. think you called what out And be on Maybe having on taking of it through Congrats able switch thoughts the alignment you and we that Thanks breakthrough for III guys FDA, with growing guess that therapy that, of back helped of that I'm the gone do Any consider started? second. get switch that that good to sort might nature read the just prepared FDA of the sparsentan. during guess, Phase questions. I between have for didn't up sure and and you to would concerns data I when going point you around program the around on designation. the eGFR based pegtibatinase at some you it FDA's kind be remarks to the should

Eric Dube

Thank you, Carter. Bill, I'll both of ask you take to those.

William Rote

that breakthrough allows the for have designation, agency. conversation additional with So the to us

development then work that moving been different to a that's side review the the you such table once different provides different the on development of where your with So the the multidisciplinary slide that then meet and the they granted, around design agency specific essentially divisions meeting with groups of path. help of It's spurs we additional and forward. elements

that endpoint, For specific what them Phase us, with will elements what III and that them then that trial means as the pediatric need on the surrogate and is on should and that data of aspects of we're working design, continue to definition be well iterative that as progression and working be manufacturing should moving currently included be, of patients process It's an development forward. it. side how of in

rephrased you your second need Phase starting greater where I for as And a So can me, to we'll sorry, better of please? we've And question to through we notes was be when that for back of that on steps I few writing asked I before some give you the with -- III specificity one. Could really I'm that. be those, study. get those vision on completed was we're

Carter Gould

sure -- do data doing And concerns? Sure. their EGFR would you having year. the of think with additional data additional to think you swage on do some helped discussions having in -- I'm being past was gone over able sure of through done data there consideration on FDA, deliver that front there I'm prior have us some that were there's or that various It the consistent no that the in work stats you performed points -- messaging. was mentioned some with statistical

William Rote

Yes.

I to X think it not sure would I'm tough or a have. it if that's answer. wouldn't

seeing alpha preserving at that as success of maintain highest was the study. key for the endpoint, We wanted the of to primary the us, confirmatory For endpoint goal. our the probability

made we really patients. of to this our best ensure for do So it the in that order delivering chance decision to way FSGS

Operator

We Laura will from question take Wedbush. our Chico from next

Laura Chico

Thanks mornings. Good very much taking the question. for

that the so from studies IgAN the obviously, the trigger Just mid-cycle I now clarify respect a PROTECT. could progressed seen anticipated data to in FSGS guess, review? follow-up. wondering comment agency on for with wondering I wanted the wanted IgAN there. both had both and just you of and -- just an have I'm study clarify these meeting in And we've has FSGS But clarification, impact if updates? completed to DUPLEX. DUPLEX might discontinuation data Just then if retention interim interim the has or somehow review amendment how to that could as

Eric Dube

DUPLEX in you please question the take Laura, for thank your can you PROTECT. Jula, study questions. on retention and

Jula Inrig

for I that. -- apologize Yes

length. have And So studies. would -- imagine, you nephrology rates of we, studies for very amount you can to continued put with progress expect seeing to what in we the make have significant sure And as efforts maintain the that of dropout of studies in range quality. patients both within the a high we're this this

proud the this we're seeing into the that put with to rates of very we're so that retention date. and efforts And we've

Eric Dube

availability to Bill, on impact FDA's how you the data and and review the would mid-cycle the might take question And like that review?

William Rote

there are both throughout has and X and through. studied the the programs sets remains diseases. FDA They case. pointed them way to and They did data vision development have There that we've are that are these different their our between program the to highlighted. differences consistently whole And own, on Certainly, designs different programs, trial independently. this key they have the are evaluating

were data, was there and DUPLEX meeting, So point the they concern their mid-cycle review at their expression on of of aware no part. the of

those, we looking in were As feedback no they we that reiterated are ADCOM and that there data, very that to that an the clear track of for plan forward gave that date frame November. us it was a result on DUPLEX was was in action and our

Operator

Canaccord. our last will the line take question Edward Nash We of from from

Edward Nash

see that it out to Or that if there taking the went Europe. just same probably the data And ahead it's guess and wait the same for would to X of I the just States is heterogeneity it years? the filing on appreciate in FSGS and increased risk kind Europeans to that did with out here if also to way my would by question see combine that issue just European of you the time? guy same that my specific view you would both you would question. averse position I be thanks risk kind for the -- really and on wanted IgAN filing Europe, also Europe, together to Hi, to would but at turn know, approval in do the filing guys the just it FSGS, also clarity clearly, have going require the confident feel

Eric Dube

thanks the that I'll over turn for to one Ed, Bill. question.

William Rote

mean unchanged. our And here get possible. ultimately, to is remains that fast I Sure. sparsentan commitment as patients as

to felt look probability year. that FDA. possible, adding same as potential that be first applications While we we process to IgAN incremental the getting our with the up potential to strategically in the and X an be Vifor If that, to we the ability forward best EMA the combination, and in would probability end is the for sparsentan the to were have a on in case We're believe deliver to our approval those approval, patients of to so as risking putting risk with the there Europe, partners, made success therefore, a of we together IgAN next now aligning regulatory view as both quickly

Operator

questions There's this time. no at further

Chris Cline

updates. for Great. joining morning everybody, this you, our Well, for us thank all of

an along way. exciting and great we rest the have look the sharing We updates forward Have second year a day. of to more the ahead, half of

Operator

Thank call. you your today's participation. concludes This for

now may You disconnect.

Travere Therapeutics (TVTX) 7 Aug 222022 Q2 Earnings call transcript