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TVTX Travere Therapeutics

Participants
Chris Cline VP, IR
Steve Aselage CEO
Neil McFarlane COO
Laura Clague CFO
Dr. Noah Rosenberg CMO
Dr. Bill Rote SVP, R&D
Joseph Schwartz Leerink
Michelle Gilson Canaccord Genuity
Lisa Bayko JMP Securities
Myles Minter William Blair
Call transcript
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Operator

Good afternoon, ladies and gentlemen, and welcome to the Retrophin Third Quarter 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would like to turn the conference to your host, Mr. Cline. Chris ahead. go Please

Chris Cline

Good Results and and Rusty. Third to Quarter Financial Corporate afternoon you, welcome everyone Retrophin's Thank Update Call.

the McFarlane, Laura Senior Vice on Executive Medical Officer; Dr. me call of Bill Steve Chief are Joining Rote, Dr. Aselage, Noah Officer; Rosenberg, Neil Chief Research Chief Clague, Officer; President and Operating Financial Officer; today Chief and Development.

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

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

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

Steve Aselage

Chris. afternoon for Thanks, everyone. joining you us Thank Good today.

a significant These represent good needs and partner During unmet the the programs our third to growth quarter, transformational Phase of we patients for organization. and deliver sparsentan progress therapies with made CNSA-XXX. significant proof-of-concept advance and are opportunity pivotal drive programs with fosmetpantotenate X to study potentially

of fosmetpantotenate Phase pivotal from for first come the the the expect X FORT We to Study of PKAN. treatment data

sight have patients on we now to will enrollment study. to execution continues complete focus line team that clinical in the Our who and of

at well-positioned in sparsentan half the and interactions PROTECT ASN We and at presented At the Kidney data DUET extension. made Nephropathy XX thus data we progress the generate International to confidence on progressive these programs of FSGS enthusiasm we U.S. sparsentan out Studies. second to approval we weeks XXXX. findings meaningful screening meetings. and an for two stage The top sites on reduction had us growing both from far the design activities pleased in Week suggested These also positive the a in to period meeting, with Phase a the follow-up and with open-label with enrollment X with Europe. that The recently proteinuria growing continues for FSGS DUPLEX of and of to IgA the support ASN, for the of Symposium X Phase international nephropathy. we've patients clinically EGFR. and DUPLEX sure give benefit our I’m stabilization with following in both DUPLEX open is the line Notably and U.S. readout ahead sparsentan ultimately the leveraged Study and the Importantly, longest remain moving Europe. track for IgA excitement Study

enable to our International the focused patients of XXXX. study in design Nephropathy the second X of on interim the goal reaching nephropathy, half XXXth with IgA the into of Phase were readout Our Study FSGS team Symposium. getting the at present to we the the PROTECT pleased remains analysis In IgA

dosing for first At approved and our therapy end. that this is both in community enthusiasm to our and of making are goal progress sparsentan is day, to become the in the the we for the IgA the nephropathy end FSGS great for effort. of patient first study sparsentan growing a nephropathy efforts, forward and we're there the year before looking result As within team's IgA

program form Phase X our Censa done and initiated in we Additionally, the who Overall, programs. the the decision The the and the study. developing across position positively our in that proud phenylketonuria or disease PKU. I'm Phase fortunate expected half impact top with opportunities readout potentially program forward Operationally, will of team clinical advancements a having exceptional on partner into option has our year. in of in Censa proof-of-concept future. move next X looking living study directly first to line multiple dosing This are help Censa The We're revenue near our growth the to in anticipated the are most There Neil of blow one people bile to our revenue at year-over-year the quarter extend acquire maintain Pharmaceuticals XXXX of job CNSA-XXX the data in the we short provide the few guidance will color the quarter the shortly. revenues, led Notably, year-over-year for significant growth. but some were fell quarter. in and additional means was coming net on end net underperformance for our in from on net will forecast, fourth acid the that we the in and below low an revenue trend but projections in improvement than of that third of performance to in products. a to anticipate million factors year. moderately lower likely revenue of XXX we our an

are We first that rebound already the signs month QX. with of of seeing strong

of some the Last Rosenberg, product us license. give or during looking quarter to Medical debt to was clinical we when us our quarter our Dr. key The who ongoing additional candidates of flexibility activity programs. Chief Our Officer. capital our plan and to will provided completion resources made for in support operations added Noah hire the a not new execute upcoming which least, a with new convertible for also allow is proactively highlight financing from in but to with us launches anticipated and addition product the successful the

role have important in execution. an Noah His here and approval directly will team from clinic we are hear for You'll clinical our the clinical team the advancing shaping to next, activity. further record very strengthens he pleased to but focus track on of him therapies and the play join

updates. call the the Noah turn Noah? now me Let over trial for to

Dr. Noah Rosenberg

to in future. partner honored here to and I’m therapies good effort be to Steve, Bill near afternoon everyone. Thanks, an the on with to exciting deliver first-in-class and patients

IgA PKAN motivated main the clinical We I to paradigm FORT in nephropathy. living like fosmetpantotenate reasons from pivotal so that was to had of of a and momentum diseases enrollment upon Retrophin very the opportunity was the lead few for with the The treatment rare last activity the have of FSGS highly thousands productive built of that pace PKAN, One of shape encouraging. could the first Study in people is the half the potentially months help the year. join

you able agreement line of have mentioned to we year-end. with to we protocol with the on As now FORT the with completion the PKAN Activities provides today special Daily have earlier, FDA that should support the a of Steve privilege that enrollment see trial Study which fosmetpantotenate. in being weeks after under assurance sight scale around of of will Living The that is the occur being registration, share treatment if of conducted significant response assessment XX clinically study, we

data With are Study, we have the a opportunity eager line of FORT second and with half the the great top XXXX. we see patients in to to readout help PKAN

IgA progress nephropathy. We FSGS programs our both with also to sparsentan make and continue in

majority patients Our with THE pivotal XXX enrollment Study now Phase are for X DUPLEX open. U.S. approximately sites of FSGS. continues efforts

with has Over investigators been encouraging. the last month, sites. these we've Indication been visiting

have the European also the first We our investigator quarter. opened and EU meeting completed sites during recently

pleased far, ensuring that protocols of So have closely Phase Study. design, been we've in aligns population that with X the we the DUET that with study the

the weeks the the at Study partial FSGS active irbesartan. As analysis in read proteinuria is interim will treatment of conditional of in sparsentan be half teams expected many control in of looking U.S. XXXX. second approximate after positive, in the working consideration either interim sparsentan Subpart of accelerated XX the are to you or approval top DUPLEX on If Right will to the endpoint hard enrollment now, and analysis a with marketing in recall, Europe. support authorization patients of out our H remission the line XXX enable

XXX of patients in of evaluating treatment. change all in EGFR be will slope XXX We after weeks

the support U.S. outcome and approval Europe. on Our will this positive endpoint in full

The global, to double-blind, attendance. during of key a sparsentan multicenter, received efficacy and upcoming PROTECT of safety nephropathy leaders the opinion program. parallel-arm, the nephropathy, pivotal evaluating key is Study. trial, for PROTECT ways IgA trial the randomized, Study investigators of IgA by well reached Phase the treatment was is This in quarter clinical X also active-controlled the At the in Symposium your We on and we pivotal milestone DUPLEX Study. design the many This XXth Phase International development IgA for X nephropathy. presented similar

from proteinuria irbesartan in endpoint treatment after PROTECT authorization a H share the key with to approximately has will been between in patients IgA U.S. Subpart of a One sparsentan outcome us here The to survival features the positive The generate nephropathy. proteinuria-based or support primary sparsentan. end weeks XX Study's approval reduction either reduction and well-documented design evaluate proteinuria assessment given conditional of with marketing point Europe. and renal of is the a of our in confidence XXX the had nephropathy independent in IgA in Study PROTECT its and potential link and baseline in for

at we before clear and expect an dedicated patient first talented enrollment three advancing therapies organization do. dosing the In of that point we timelines readout. it have life-changing has at milestone year-end in keeping the we data center anticipate become need patients that to we Importantly, months, provide and first collectively my extremely for everything to

We upon have success. I some made to looking helping forward great the delve and team accomplishments am recent

Bill me additional research Let and development. for turn over updates in Bill. to

Dr. Bill Rote

Noah. Thanks,

momentum exciting sparsentan programs. San Week at with XX own from Meeting This out of that last also about in and and Noah's increasing can the portion study Notably, durable enthusiasm achieving week EGFR have our a and saw reductions XX for Nephrology Treatment is who growing extension encouraging. at stabilization weeks. patients you DUET sparsentan fact held comments, It the new also great patients double-blind was Diego. build, ASN two-thirds was proportion you of to from open-label recent this our The Premier tell in extension, was remain for data we in in of the Meeting DUET backyard. of to today, year's the completed FPRE. extension in with the to we As proteinuria the those an associated support of open-label evident continue programs open-label Kidney the very

announce manuscript data field bolster helps and X to DUPLEX our sparsentan the in the nearly have potential receiving been the FSGS. the have of featured as support Study for us increased meeting. from pleased foundational the patients in approval Session to Phase confidence that Best of were these as design DUET Journal part position We of continue DUET Study JASN four and give our These years developing of to benefit. sparsentan. ultimately at the JASN of Some has also of data the publication publication it therapies The of for leaders the

Study As doing Noah Study. make our FORT also in beyond to FORT the support fosmetpantotenate. with fosmetpantotenate considerable eventual work submission continues strides NDA the program to for mentioned, enrollment the We're

us line and process of parallel planning NDA study enroll sight to we having the effort advancing look Now the will to with that start in the last conduct. to to patients allows forward

physician for treatment now therapy Additionally, four therapy the through on to four protocols initiated patients continue years. up receiving to remain stable

I'll is of and the been for Pharmaceuticals. CNSA-XXX remain option joint progress excellent we Censa Censa work to being program. at treatment Lastly, briefly encouraged advancing a touch under and by in on has PKU which PKU their The with agreement team development partner an with the program developed

sites initiated Censa quarter, Phase study. commenced proof-of-concept in X third the recently the and dosing During

that We the XXXX. to on be study results from continue of first available half to the expect

Let Neil the me Neil? turn for operational to the call over now update.

Neil McFarlane

we growth which top quarter third From in million net line perspective, a sales $XX.X the Bill. in resulted revenue the continue period. year-over-year product to organic Thanks, for in see

to quarter, efforts team's Thiola in cystinuria. formulations friendly more of formulation in XXXX, to this new half before for the launch keep to NDA of FDA partner Also track the the the us with will XXXX. date patient and of and of Thiola. We more Thiola quarter remains the second a filing new PDUFA submitted of diagnosed NDA an the approval which our reaching Our for patient submission patients for note effective anticipate identify acceptance during year-end on

product preparations. our progress new patients continue treatment We this for experience making launch we improve are cystinuria excited to for solid the be about potential with the and to

acid During expectations. bile saw expected led revenue additions fewer in which products the below to we coming the quarter, than our with mutation

than we in uneven indications quarter, past, identification the the As in impactful we uneven more have staying an and talked the treat. in nature patient about previous on was nature often that bile with therapy third acid ultra see quarters. our therapies patient In rate

in why As territory of is rare team net end million. a The low periods Retrophin collective expertise XXXX disease result, growth. XXXX we we have quarter seeing our were a a stronger and in and moderately To $XXX and team's below ability us we to end, degree guidance to deep anticipate likely that year-over-year high create uneven start in trend ahead. for at we has our commercial confidence a the in continuing of the are new fourth years the growth in revenue treatments, already are of not the this delivering of further

are we after offering. in the flexibility notes added convertible business to activities pleased Finally, have some recent development our

continues Our commercial disciplined and approach additional assets layer in earnest. portfolio into to the pipeline

the financials. to the Laura? turn me let Now, call over to you walk Laura through

Laura Clague

Neil. Thanks

We million. the $XX.X loss adjusting quarter loss quarter, During reported for non-cash portfolio a reported from we net million, $XX.X and million. of After income XXXX. commercial net tax for million benefit expenses net GAAP $XX.X to the of product of non-GAAP sales third third $XX.X of our grew

we The for $XX.X pivotal period CNSA-XXX. programs, funding to increase quarter. as of XXXX the is the third in million Selling, the our quarter. the were $XX.X The and of non-GAAP on outstanding initiatives $XX.X adjusted increased is to increase a loss of $X.X non-cash basis, approximately higher the to amortization. million stock-based and our million third XXXX. basis, principles in R&D approximately expenses support notes compensation third included of compared adjustments million a and were product. non-cash to period During an and XX basis, XX convertible expenses SG&A as third fosmetpantotenate Significant to million half early or an in expenses quarter extinguishment well general GAAP sparsentan million for the commercial This Relevant XXXX R&D last expenses quarter, XXXX. On related related for for expenses million support quarter our and consisted the September. of to stock-based an were adjusted repurchase to incurred compensation due the is due quarter of quarter amortization. were third third administrative primarily million $X.X debt. On year largely same over for On $XX.X development expenses in the for same the depreciation of

and in This successful convertible As the cash of XX, and September marketable in from securities. XXXX, net equivalents million we proceeds $XXX.X cash our reflects offering September. had note

our enrolment, we’re at expect call Looking quarter expense full Phase to line in ahead, I initiation marginally stages near current the may moderately expense for to vary by to his back our than comments. from remain operating over the now levels With to higher Steve we will turn quarter. three, various to X program site what Steve? closing likely R&D upward. trend advancing

Steve Aselage

becoming stronger the organization, towards Across company. continue and disease to Laura. rare progress make get goal Thanks, our of we considerable preeminent a

create organization. substantial have to time same and IgAN we the the FSGS for programs value how Our three total potential and treat at PKAN, transform our

execute upcoming XXXX, we to never a in reaching been starting data forward close have to look we better position XXXX. on key and we readout As

the Let me to call Chris. Chris for now turn question. over

Chris Cline

the Steve. open ahead Thanks, Rusty, go please. and line for we can Q&A up

Operator

comes [Operator the Joseph The first Instructions] line Schwartz. question from of

line Your now open. is

Joseph Schwartz

that are more point been DUPLEX year just Study be given this evolving? wondering am primary Is out I data you will being you on last wondering, which in XX you're Since updated? hasn’t Just of more analysis some why at is patients a you are endpoint included the on is can endpoint open-label for was are stable drug that analysis, that heterogeneous? you this and using in XX XX valuable XX just patients in Phase in XX weeks. you FSGS the FPRE endpoint on couple I as are fairly patients that been partial the I at weeks endpoint to questions Phase X. sparsentan. ago. data Are how X the FSGS DUET the remission extension the there data weeks around see study think clearly I'm include and people think reported that over reporting ASN XX seeing at have data evaluated out that I patients has the achieving now

Steve Aselage

the With cut, ends have increased. and the later year prior later almost since data year's and half a the

So, the group group. so [urbs at bar] you’re and group, bar] FPRE in [urbs and the little you’re little the you’re in the XX [spars XX in bar] higher in something patients around lower XX% group, XX [spars bar] almost right

becomes what data confidence to and see end, increase more this for in a the set we is solid going representative is DUPLEX. there, good we’re As the that

Joseph Schwartz

only why DUPLEX sparsentan titrate And with the is to Study to is curious there Study option XXX PROTECT up then regarding I'm Study? XXX in nephropathy, DUET and the milligrams like the evaluating without IgA the

Steve Aselage

I Yes, I take Noah going way. think that ask either that or to to fill I’m can

Dr. Noah Rosenberg

so Yes, serum with when words albumin question. highly exposure levels are is lower. in other so Sparsentan is AUC correlated drug great indicating bound, exposure albumin low, protein that was positively

IgAN milligram dose was from the day grams those to that per IgAN the with levels patients to clear doses with other FSGS, order levels may up and our proteinuria, with per XXX the DUPLEX, in these to dose. with contention So have make X just between dosage grams may lower levels risk of of XX that, Therefore, serum XXX higher proteinuria patients albumin cases FSGS lower the exposure. In achieve than words dose. important some levels to weren't of drive adequate progression throughout to X patients you from it which preferable of in proteinuria, sparsentan in day. Patients is higher for milligrams at generally benefit benefit higher contrast,

Operator

comes the Raycroft. line from question Next Maury of

open. line Your is

Unidentified Analyst

for David is Maury. This

are to new that’s IP keep then, entry just general can you So completion? this generic Thiola, comment guys you barrier to And entrenchment for functioned for a generic out formulation on thoughts generic? for completion how the going Retrophin's as and may the the just be how on confident regarding competitive if the

Steve Aselage

I the new IP, product odds of really want, submitted. about but and think about formulation feel we've the only in thing good can't and we say improvements made what what filed that that issues forecast we comfortable the getting feel I for have we are issues until as it we we would have hopeful IP meaningful we

is the of terms now. amount generics, around generics there In a of right obviously huge noise

front is in that probably of again December. to get pending legislation Some going in Congress

think see about we of how I product the to the half anticipate out. as the now. about years grow play and things better the I feel have in this have think should that We filed come. we as next quarter we future So, we launching even the franchise feel wait submission product goes, far market We good for year for and second the many that to on federal

Unidentified Analyst

have question you equally is like level severity on Are pediatric the can PKAN, are up second opened what's demographically? trials My you then now they and just size, for contributing the more on the regarding comment that patients. they comment enrolling, can

Steve Aselage

we year we detail, and of the had patients. demographics I ran that order DMC that the but I any comment committee to your way. We go answer and question a a that up monitoring pediatric level the Well, through in to was in I to in gateway on had this open don't earlier data think are position that think can that

adults. after started enrollment the their enrollment of So the

somewhere diverse a distribution, around probably and a of As we third pediatrics up it's site of the quarter expect relative across far of total end adults. with two patients population, fairly is as a been where to to it's from

Unidentified Analyst

the this just from is Kidney you like us one in question, So feedback terms your can of of some give sparsentan program? the sort sentiment regarding ideas Or Week? last

Steve Aselage

saw is those of Bill patients And and We had in like of to remission our I think Noah continue is weeks. I and Study. portents those improve nephropathy But and they XX I so could interactions not got stay ability then Let We think therapy dataset. long-term most that maybe enroll We Noah, well we extension. XX little you saw think ever either on experience patients on better me saw I some IgA ask the can data but have positive open-label as the and feed there than over both other both think proteinuria enthusiasm We XX PROTECT on asked for Bill or DUPLEX in a the expand weeks, that which unveiling I it a to study those FSGS, in overlap the a over Study was into the weeks. that area think an for we have with stay reductions to had and more a start comment, well I'll and sparsentan did, itself this. the I with data, the bit. the

Dr. Noah Rosenberg

point, Yes, I Steve agree. would just amplified completely I

the again it’s really DUET and that the sparsentan data this was scientists large that, presentation into Study to critical confidence serious get renal translated really able the get coordinators but I a only study at needs now by for DUPLEX the study, FSGS. outside being lot landmark of ASN community and Retrophin of this life-threatening renal term DUPLEX was done. patient this for a disease was think used community done, especially to terms investigators, groups and is is not that the The used gave in for a in advocacy at recoupment term really that levers

many is to up our add So, or us on I to want wing, I to don't beneath all. and ourselves Bill, rise get wind alignment know and if fronts under should say help there that some done. this

Dr. Bill Rote

Noah, it well. I up summed think you've real

Operator

of the question comes Next line with Michelle Gilson.

now open. is line Your

Michelle Gilson

and different IgAN? significant different And as in that your context design say trial a you to can kind improvement for expectation arms? with you ASN. no presentation. about, for first and and last just for frame the guys data PKU What you arms was of It periods XX week question just CNSA-XXX my congrats the your be I ask of for washout well, treatment taking on it would would what great the to more the CNSA-XXX? half at Thank over is just kind you wanted data

Dr. Bill Rote

This is Bill.

look the be superior standard you at relative fundamentally the it CNSA-XXX, With of when to care. the should current data

incremental not control. that bioavailability significant know standpoint, increases We’re availability patient to molecule actual for services improvement. tissue in has We looking the enzyme. well as a From very is a each as where as own the an serves study the helper their compound

individual to how have and an current the of they measurement within a of we respond then the different of patient, So doses standard compound. care two CNSA on

between So data of we have group. between a to those out good just see it we of that's as compounds. the of that adequate why you -- the to Is very level should And have on robust coming the an the that level study have provide what both characterization helpful? the exist as is well is and that way two designed comparison what superiority delta is that individual

Michelle Gilson

fosmetpantotenate. that and controlling you of how these about siblings just the episodes one control can PKAN distress on And Obviously, in within the your that just there talk talk patients? study you're the ISTs help design and way these two you to had Can PKAN-ADL study? just in that for of then might variability the about intra-patient first these were variability some intra-patient

Dr. Bill Rote

how is Sure, do chair domains, your in they reported reported are you you across process writing. well mechanism feel understand or interview can a out different and or understand through well an the how measure, of right caregiver accessed when function people outcome do they the they how you, you of how get the PKAN-ADL to patient people speak outcome measure

and like to patient this, types that's long partially going they significant this with a questionnaires that's like are assessed that of goes trial very variability. change With by a in in interviewer over from to toward going So, a in of day-to-day a periods some repeatedly variability, any be PI. each always based you're suffering sense there the but disease population common done measurements, the see throughout of the that this. the partially case amount the in that measure said, there's in that way of The fact trained case are

think the measure. we population you going that that leave patients, all but this variability accommodate I population going impression So, there that to are want inherent of with to think don't sufficient size type in trial I patient with XX the I tamp this are to the is of noise, we see to the out with

Michelle Gilson

in data get And natural the at recently. then, bit about in little terms us baseline you you saw design? had we of talk history design with that should what comfortable these can And And a you help trial characteristics in how you and kind some of look us symptoms? each onset how MDS Can just at informed of they that how get trial data?

Dr. Bill Rote

or effort from Sure, the stemmed develop it scale. to data PKAN-ADL those conducted was extended the

So, it to going were was to around they the different on. caregivers domains an effort interviewing and evaluated patients be

with the of and is scales. trial of and PKAN degree improvement. of part a severity, I patients. those a that Should comes divergence diseases data, out see reasons is clinical in that you think I occur? no as plenty improvement to room there's see that you spread different scale, scale It's pretty many think you look at do that genetic but fair in heterogeneity in good across the there the that that XX is is those from

a a that in Phase disease of two study see X studies XX of a are You lot rare dozen levels variability. that dozen and patients this manage or is those part to is of

Operator

Next of line Liisa Bayko. question comes from the

open. is Your line now

Unidentified Analyst

This for is Liisa. Jon

patient trends lower you new you're the acid said on products bit little the they other. expected couple than that are bile a saying Just for

seeing both Cholbam then that's there what you lagging hope about if that a both Chenodal products or and one bit is you’re little can speak behind? So was for

Neil McFarlane

how on space, sales, Hi, John, a it's therapy have Neil. then you in rare Thanks see also for the starts consistent ultra and even questions. not patients in stay Whenever manner. on don't you consistent this disease operate is usually they

starts are an that’s some in revenues, already It out see We actually month at quarter troughs increase in the moving September, this resulted into of patient fourth but October. lower have we in close in quarter. patients this particularly specifically of

Unidentified Analyst

you will therapy and option candidate. you feedback competitive program, if to saw PKU speak one you early affect that you affects And all wondering, just on up? and stage how programs recently view gene I kind some on the if then coming previous the was data kind PKU we a And therapy question of your have the -- decision gene of when from

Neil McFarlane

We certainly programs. gene therapy monitor

the be in We rare The are visible therapy XX% programs getting diseases therapy gene early. major company. increasingly most obviously say are PKU PKU be It's gene say too more more the disease is going and to an rare see. gene not. a It remains it's and gets it's early therapy in like competitor it answer will genetic origin. if of we seen, early to this is be too your to to and to going

want then think just therapy we see the have forward. a away, of walk things and which I distribution, from and to cross if another we’re if evolve. head blood-brain about it know is we its its program. we if better tissue pharmaco it commercially We What to think is is as optimistic ability is be to know is want and We a CNSA-XXX. if now, care it the right companies, think move see good that then And available want standard we tetrahydrobiopterin we products the we head. for improve we to giving to we to can will barrier, not characteristics gives it but kinetics its is to a very it do as product out maybe, potential patients how by

Operator

line Tim the Lugo. of question comes from Next

Your line open. now is

Myles Minter

it DUPLEX It's just of as Tim behind, from about PROTECT proteinuria Blair. Myles it could I’m and not you'd wondering is patients doing weeks right the Study why where just standpoint? because to a perform the about I is else Am out a not William opposed much? the term here? at XXX that expedited concept rate as Or rationale be just in Study, GFI the you're at of as severity IgA weeks the am therapeutic XX there thinking on an something missing longer for I

Dr. Bill Rote

your do as have at robust pre-specifying that There you effect got This go end one to is points the that a And a package not of that decision, year have Bill. you you more if is you're challenge. becomes enough chance make then and file? a you one and of that

you variability not as FSGS we IgA at it and a a are compare is IgA whole the nephropathy magnitude that excuse the is dataset the overtime, and lot progression that if compare changes as to to slower, you -- the the lower. great but If population, the me, looked

at the chance there So, designed hit it is and we really that end probability. that’s you around study the that’s could point, think two successful and year don't to is and to But there highest I to one be The when year. expect be the an be point don't year? that's one on study We the, opportunity capture that where run in is want that that long. should it. so there data for we that,

Myles Minter

remission of you'd PROTECT for but accelerated the you in bars for you pathway? on you the So, chase proteinuria still GFI, the if the you approval think Study, natural hit are looking really hit if [indiscernible]? position Or where

Dr. Bill Rote

or for conditional to H the subpart the hit confer confirmatory thesis studies the we file And as can at accelerated and on then in to approval study EMA. in which the by file to foolproof. endpoint a is eGFR marketing it the then, endpoint to approval No, primary proteinuria runs both weeks XX

Myles Minter

at stayed And way, looking had DUET in patients then by I'm we just but XX the currently. originally rates down not and XX to XX really particular the for dropout

got compliance in dropout but increased to Is that the So, see XXX-week over you [indiscernible] Or that kind patients rate? a of assume two-thirds is period. DUPLEX to there still the where that there, going trial? it have thinking we’re I'm safe Study similar

Dr. Bill Rote

Crystal knew. quite of patients on I'm to years balls eye there. four look coming and blood some and want are keep clinical just up that. of a We keep impressed that draws happy. them are to they an they leveled them patient the do continuing the DUPLEX staying managing to rigorous in of the scheduled tough. it's in the the extra participate in trials And for the are because assessment, you visit, you just out want I in trial, wish experience at towards all Well, always with

fits they for these The with that's in be is confidence. not back on similar see and the patients the and the course are more and life a the It’s we it's coordinators stable have That on it experience it disease. being into the really we written other that from it. before piece happy a They benefits, study a will arduous to this with knowing gives that to have a happy. their in helpful. Well, that me are not take. and investigators. that And effect daily isn't very study medicine physicians enjoy anecdotally Their seen difficult drug the solid proteinuria optimism get on their them profile people works the able it's be pressure side that patients blood rock the DUPLEX or and because oral to long-term knowing and reasonable of like

about that's seeing they and in that overlapping to to longer. Now flows But certain a forward studies. is people DUPLEX point with talking open- get knowledge benefit the get current challenge in label you're the DUET before both also got PROTECT we've is what open-label, to PIs and the that and into

to hopeful the X that data every these day. dropouts I'm patients missing an on lots focus Phase it be not is -- are going of So and we issue, aren’t every all with things program HERX HERX, it's

Myles Minter

much very question. last Thanks the I the will and color promise it’s for

that differentiating to cognitive Wondering looking patients. would crossing CNSA-XXX, that’s factor Just cognition? And over PKU essential valid is potential head end to the barrier in blood-brain trough trial talk to function? say actually to that about benefiting potentially looking is Censa be superiority in point whether the by superiority you you’re at take I an do is, and with do for to conducted any some

Dr. Bill Rote

certainly a patients that, in would just a study, [indiscernible], but much no between really their we be levels in endpoint see the to will cognitive that evaluating the and looking is for different cognition. for something change to study. difference groups. but way the So, it's in need be in that the current at much larger This more be power That's a difficult they function,

Steve Aselage

benefit is have study have in the the a a This in neurocognitive to Any duration as have as study longer much CNSA then would well. study get that reduction given, kind of of reasonably simply has treatment -- the than of we dose answer can provide I can fee couple different a and we Censa in we quickly. of doses blood maximum at terms think greater

Operator

at Instructions] the time. this conference [Operator would Thank now I'm to no questions I Mr. you, turn like back Cline. showing sir. to Chris further

Chris Cline

Great. Thanks, products Rusty. our Thank on you everybody. This future. concludes our to you near in call. We look forward updating

Operator

concludes participation conference. Ladies day. gentlemen, wonderful this Thank you for a and and today's have your

disconnect. all may You