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TVTX Travere Therapeutics

Participants
Chris Cline Vice President, Investor Relations and Corporate Communications
Eric Dube Chief Executive Officer
Noah Rosenberg Chief Medical Officer
Peter Heerma Chief Commercial Officer
Laura Clague Chief Financial Officer
Bill Rote Senior Vice President, Research and Development
Greg Harrison Bank of America
Carter Gould Barclays
Joseph Schwartz SVB Leerink
Michelle Gilson Canaccord Genuity
Maury Raycroft Jefferies
Liisa Bayko Evercore ISI
Laura Chico Wedbush Securities
Call transcript
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Operator

Good afternoon, ladies and gentlemen. And welcome to Travere Therapeutics Fourth Quarter and Full Year 2020 Financial Results and Corporate Update. 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. to conference like host, to now Mr. would turn over the your I Cline. Chris Thank you. ahead, Please sir. go

Chris Cline

remarks Chief by Rosenberg; will you, Thank results Officer; our Eric Development Medical Officer, afternoon, I of the will and call. Eric Good be the for Katrina. you Dube. be hope Financial Noah full fourth Travere our for Thank our Research well. year quarter you Therapeutics led all Q&A us XXXX Officer, Today's Dr. Senior Chief Peter our prepared Heerma, Clague. joining by Bill Commercial joined Dr. and financial Dr. and Laura Vice for and join session. remain update and Chief corporate Officer, us. welcome call will Rote, to Executive Chief President

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

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

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

Eric Dube

study shortly. the forward with about achieving were its that you proteinuria DUPLEX good And Chris. with a you, beginning high endpoint. a interim bit to with note of on afternoon, And Thank the discussing we more very year look recently We pleased everyone. the

excellent to and the therapies delivering XXXX. disease. that direct execution identifying, our work and of reflect to is a mission would of I on result living dedication This in our we changing people hard First, rare with to like life developing had members team

at Our focused as disease key in position areas, leader a community. aimed objectives year rare our the on strengthening three were last

FSGS and achieving are the PROTECT schedule. line readouts original key both to which in efforts US advancing continue in pivotal In accelerated of its beginning studies support X nephropathy. in to become The first from was to these proteinuria was Phase nephropathy. goal interim for the standard IgA treatment is and FSGS to PROTECT endpoints, in now readouts a to sparsentan necessary to authorization submissions enable and sparsentan two led milestones so, our programs position IgA our doing new and approved. high patient for study a teams these and Despite quality potential if continued operational approval well-ahead designed this two done their rare interim our both enrollment safety the of including kidney have and the top in Furthermore, the ensuring pandemic, Both year. conditional of job disorders clinical Europe DUPLEX marketing ongoing the potentially phenomenal study

am to of The sparsentan benefit for access maintained that last second may products, approved. we from that pleased for our year. supply our building new identify organization report established throughout well patients pandemic as successful launch key commercialization and a to capabilities objective patients to was as approved preparing our upon if the begin I our

and deeper journey patients needs, in of includes both products. all the to new where patients patients nephropathy. We approved understanding launch of our preparation This understanding our identify our for IgA In sparsentan, a we also potential may FSGS of for continue furthered of can patients, our be successful play. and the believe to with physicians identified, established profile pathway capabilities, that clear if earlier these in commercialization for their sparsentan us insights diagnosis Together deeper a therapeutic future provide with that delivering desire be approved. the we role patient

a This year that deliver potentially HCU people exceeding importantly, Our therapy to through added COVID-XX transformative business meeting disciplined us faced anticipated to fourth limited we from organization's efforts. capabilities catalysts year. the classical money. options last of for to commercialization XXXX, suggests the third performance exciting the and potential living to of that new potential This replacement for treatment our TVT-XXXhas to a growth and to multiple Current a year, for for In given challenges disease HCU. therapy objectives on X/X We TVT-XXX, for currently incredibly stage in we be driven XXXX. in and this pandemic. treatment meaningful diversify set that by the and novel all our late homocystinuria our even treatment key ideal is year path more top I'm for our option it human notable is quarter led the in first on further fit is development program believe leverage mission clinical this expertise. is last us development our have our It in objective for potentially HCU execution modifying a provides for to pipelines pleased data development allows ineffective was in Pre our pipeline enzyme adjusting Phase of HCU. or or sparsentan. with the investigational us our it which an with the are pipeline and potential

after analysis, we and for endpoint remission As accelerated of approval data I mentioned FSGS achieved FSGS study from or to both intend the in its for of our in on sparsentan FSGS proteinuria treatment. interim US earlier, the DUPLEX partial Based FPRE of pursue submissions the XX-weeks interim pre-specified Europe.

for third sparsentan proteinuria on pivotal from assessment remains as on to this this for both assessments IgA from year. The our treatment PROTECT behind has could coming delivering interactions, proteinuria readout as our regulators and successful, continuing FSGS the NDA interim if to MAA IgA sparsentan in turns standard preparing the with in year. quarter engaging submissions significant nephropathy our line for FSGS interim months, preparations also next in in have in the step If new study of increased our forward this meaningful further approved. potential interim the upcoming The ongoing of look report reaching We and goal nephropathy. standard DUPLEX our confidence milestone to IgA later potentially results the and With our towards in a treatment track regulatory in top and treatment effect to FSGS towards nephropathy. us, IgA a be delivering the building goal focus of a new in

½ of certainly year, important HCU have concept in we we number of become TVT-XXX also data our later for study proof While expect planned a updates available this of sparsentan from do to ongoing Phase year. this preliminary

the fully HCU. this understanding house, now advance of potential We are in have to excited and and in to our candidate its program

forward Our need address patients goal significant year will community. for in throughout unmet expeditious be this the to to help most the the path identify

clinical turn an over Let now me Noah? our the for call programs. to update Noah on

Noah Rosenberg

teams. be continue our execution afternoon. our the Thank and the you, operations programs, advancement pipeline very Eric. with pleased of and good of clinical to I And

academic has Since Eric Phase in we've interim the the study mentioned these top data advocacy. and for the in decades, been reported results driving engaged community announcing patient earlier, pre-specified participating with in feedback excited responsible nephrology assessment the been since the in from ongoing line DUPLEX of As of and consistent. Many about announcement, we clinical the in FSGS. heard, of leaders line FSGS. top leaders research X recently and have are have sparsentan The directing hope for advancements we overwhelmingly

For preserve been tremendous analysis, interim the highlight understanding sparsentan over will be program kidney FSGS details as however, contributed a there integrity for to the for additional providing remains. formulate study trial to disorders. I of not be have helped innovation of aspects from our key to Today, the excitement like that the that would, there's continue lack years, need time. still DUPLEX potential while offers. much we to ongoing is our rare there two of view in a for has treatment to And the

in This sustained is FPRE, designing and to or easily treating or gram, is amongst Study, defined of First, the less reduction than X pooled UP/C and or proteinuria kidney than DUPLEX with subsequently long trials, goal has greater UP/C that had urine better meaningfully from it nephrologists protein-to-creatinine partial treatment meaningful achieving clinically as endpoint and gram X.X foundational When ratio Study patients and of FPRE. derive FSGS closely from not recognized independent analyses demonstrated the NEPTUNE equal Consortium proteinuria work per survival. reduction baseline. remission complete This XX% cohorts to DUET as work primary a a remission we achieved. been FSGS FSGS

We link this and encouraging FPRE establishment with but the on and considered of submissions a would also FSGS. ever that active control, the a with XXX to approval. Importantly, design care, standards provide one create on which between for provided reduction study allowed largest regulatory weeks survival meaningful FSGS. It the the measurement support kidney It and for preservation Study compared following of between with eGFR eGFR in interventional for showed response data now approved modeling irbesartan, weeks at this sparsentan X or confidence of to significant our Phase a treatment us statistically XX have demonstrated treatment. to interim of not clinical measurement proteinuria DUPLEX, length accelerated from and clinically DUPLEX of is sparsentan the FPRE sufficient that potentially strong

and analysis FPRE to a irbesartan. an X are sustained proteinuria the to treatment reduction period the sparsentan reduction FPRE data increasing over This generated achieving eGFR stabilization interim reported likelihood These FSGS. DUET, open consistent to In and an in of of was the compared label greater demonstrating sparsentan Study DUET. that in Phase extension. associated in XX-weeks our resulted from with with durable a the relative with DUPLEX Although, in out of in response treatment extended XX% proteinuria results

profile safety We a understanding to also tolerability of have date. sparsentan’s strong and

to period. generally mechanism assessment and data it ongoing safety XXX This overall four the provided than to open and extension, or multiple drugs very the groups. with an applications have subjects in well this draw is sparsentan how generally from has comparable interim study. some Phase treatment recently, fortunate label encouraging out interim the have throughout beyond between been into has our more beyond completed in years. critical that ongoing tolerated, for years, date studies the DUPLEX extended be performs most indicated, a X the clinical a median are safety DUET over comprehensive history. to program's extend patients profiles And has database six We In from insight for and study the been been able This followed going both we

submissions. acting community. dual endothelin sparsentan pathways type receptors. by recent are There that approval, type to of treatment accelerated affinity authorization just the Both with not applications understood the is for high are a treatment of believe has in pathways well are independent of if been one as on FSGS. a for for coming and for components on the act for one, US importance entering with assessment antagonists nephrology We the interim of that in plans optimize both become these to and a both forward options standard, we the ERA European targeting, There clear the DUPLEX acts both goal angiotensin analysis submissions months and together sparsentan well of conditional these proteinuria X parallel, with Finally, but the the a characterized continuing XXXX. A interim including potential of and need second marketing FSGS and the to and the ARV new new engaging growing in consistent sparsentan of support treatment supports evidence, FSGS patients. look body approved. to regulators And half prepare In the in our we

to As data also the proteinuria in treatment of Eric nephropathy. sparsentan confidence our mentioned, us interim further IgA with developing provide approach for the

this a on of believe is previously, important blockade inhibition lower running FSGS anti an will IgA multiple and rationale role populations. a top share the proteinuria due inflammatory has nephropathy in proteinuria provide the outlined for IgA common male believe to diseases. where that to ERA combined work play in plays a [ph] disease our And sparsentan role fact preclinical both angiotensin successful. we been properties seen we've demonstrated key that pathway and has in We sparsentan been these of in active study nephropathy, with the strong in As facts,

progression We of treatment to nephrology enthusiasm continue the slow for strong non-immune communities and disease. see a from patient to suppressants option new, based

IgA in enroll to As the our X PROTECT completion. a Study continues Phase continues nephropathy pivotal study to result, advance, and towards

report year. focus the quarter line data assessment we from this to the inner top of Importantly, third in proteinuria track remain on

Finally, escalation advance dose to the Phase X/X TVT-XXX in program continues study. the

have to Overall, will unmet adjustments made better and in available. be becoming of reduce that path studies identify I to to gain we that forward trials timing to to of goals result significant the call need generate dosing, Our and later incredibly this with potential TVT-XXX to regulatory for Peter? need for us we its optimal today, over the are with treatment preliminary new a Peter the we the patients Based to this monitor as the data COVID-XX understand program update. on this would to possible. over am commercial understanding meaningful year, pleased other clinical could know patients potential options. we our homocysteine to our what to the as how the the year. meaningfully continue which any upon address of progress continuing quickly in anticipate I'll impact our for community, our levels, potentially clinical programs, for hope now best positioned has allow Similar turn desperately TVT-XXX, execution data and last

Peter Heerma

Thank you, Noah.

to its And Our the we commercial strongest XXXX. products COVID-XX, treated as team their sales are their have hard yet, of by quadrupled the one years. support of and approved last and maintained our of make over ensured uninterrupted patient a our patients the organization with we six Despite work, our of number has passion have patients. of The therapies, challenges serve. focus members for we driven approved difference result ongoing of a in supply for inspired and patients our steady the performances access

through As engagement we with continue identify ATPs. new to effectively virtual patients

XX% by across as exceeding sales Our in XXXX, of was increase driven digit single well of remained of on set approved our guidance of new single consistently products, commitment formulation screening as cumulative to driven portfolio demand patient geneticists teams in translated to spectrum esthetic a The the steady. a provide increase therapy all organic remained moderate compliance. diabetic net strong educate treating Cholbam Cholbam growth patience. easy This for product in continues initiating importance XXXX patients as by in Demand the involvement to mid acid - beginning our over see XXXX. THIOLA efforts genetic to our and disorders, to of bile Zellweger of well pediatric growth as

shifts Looking patient's their COVID-XX as for ahead, we insurance in will continue well to physicians. monitor patient as any to see related impact ability on potential coverage,

in and in As including the the Year. anticipate discounts first has of quarter, net higher by for in gross coverage the been we difficult even growth past, the sales years, driven product us net insurance beginning anticipated in throughout changes the the years New

mid for Importantly, we single be can year achieve our of we believe XXXX. there digit demands will therapies continued for approved the full growth that

in established sparsentan we to the deliver look our and approved. approved. forward with our will gain organization apply product infrastructure will the of new and now and allow launch Laura deep pediatric deliver pleased as this in sharing teams THIOLA future plan leverage Albireo pipeline. to simultaneously our representatives team development on our for capabilities with experience and living we programs also agreement enter financial efforts To with leverage US to and to co-promotion future XX year our success coming commercialization of a from effectively agreement patients progress global strengthen to product over relationship more leadership next existing We leverage if the in Throughout for if the logs experience if comprised our into both our end, strategic Cholbam to with call Laura? turn [ph] with continue update. innovative success, and PFIC. sales about hepatologist, the of position to to We approved. quarters. for demonstrated odevixibat the option treatment to current were focus continued launches you our to an They like to to to our XXXX, to recently feel This preparing I'd strengths

Laura Clague

Thank you, Peter.

our quarter, million, $XX sales XXXX. the same from net period the in grew increase During portfolio over commercial fourth product X% to a

For the We in reported full net net the XXXX, to for completed of in in Center a [indiscernible] $XXX.X XXXX. TVT-XXX $XXX.X the fourth expense the IPR&D we million Technologies quarter loss includes sales. reported Orphan of year. This GAAP of the quarter we year million fourth reported acquisition of related of million $XX last approximately directly

and million to and basis, $XXX.X GAAP for full the million decrease and the expenses for and $XXX.X million quarter support income as XXXX The fourth for for and organization the were GAAP non-cash a attributable the adjusted $XX.X amortization. and XXXX. the $XX.X development XXXX. in our to quarter, to For full $XXX.X quarter, in compensation year the On of of in of and the based adjustments expenses same for higher to clinical the over $XX.X and as GAAP growth is year non-cash for $XXX.X increase Significant based and fourth After R&D The transaction. fourth stock the The the non-GAAP the expenses over a support for discontinuation to fourth quarter increase fourth Relevant XXXX. basis, XXXX On for expense the XXXX, well compared depreciation year largely consisted full a for were fosmetpantotenate million SG&A the development million expenses the full loss year for for XXXX. million. year and were quarter our net R&D compensation the largely quarter the non-GAAP and professional and an higher quarter $XX.X $XX.X XXXX. fourth million million general expenses $XXX.X of XXXX million $XX.X basis the selling, loss year adjusting On million reported administrative was $XXX full efforts, XXXX. expenses million increased compensation TVT-XXX included program $X.X expenses stock full to an fourth of the basis, is the for is net million On tax, were adjusted product we attributable period for ongoing of fees. largely attributable quarter amortization.

increase will endpoints our confirmatory XXXX, eGFR As operating we as we as and continue pivotal look we XXXX, to in to ahead to sparsentan studies develop expenses the advance continue year-over-year that anticipate quarter-over-quarter and TVT-XXX. of to two

be this We two will further for investing also approved. launches, sparsentan in year XXXX potential to prepare the if

our of Our remained resulted strong. which We cash as we the that in Notwithstanding million completed In of Eric? proceeds $XXX.X is approximately next financial support reflected cash sparsentan hand in this This call beyond anticipated sheet includes with studies foundation IgA FSGS development, business and year, and equivalents. the expected and million, not next the yet I support the closing program. is $XXX nephropathy, to common end the his to this as stock cash additional the launches total for net ended to balance the activity in comments. back offering year. year of February, balance as a in the and Eric X for FSGS plans TVT-XXX years. ongoing operations well now Phase over development two will the

Eric Dube

dedication like Travere. Laura. I would and was each team a today contributions service XXXX their pandemic. members how excellent their year your and to living for thank Laura. every patients, our with execution shown Their incredibly achieving rare for a day for to of for be the Thank our together partners of spend clear could goals to What And common patients even us. a Happy objectives, come science we Birthday, Excellent. continued global and goal one way you, when and disease. that we focus successful face our on have for with efforts in elevating with in our of of a

high purpose positive carrying our interactions, on into this continuing sparsentan and In conduct. quality XXXX. study New in the regulatory dedication programs and through will continued the Year, same are we momentum upcoming We focus

commercialization meet if for such needs and the sustainable And Chris? also call patients with that, to a diverse programs over back TVT-XXX, so capabilities, living will advancing the growth will on in continue sparsentan focus our let focus can disease effectively leader we we strengthening We Q&A. that build on as With the me our to IgA nephropathy rare to is further of community. FSGS turn as Chris approved.

Chris Cline

for Great. Q&A? Thank you, please ahead go and we open Eric. can lines Katrina, up the

Operator

Instructions] [Operator Greg the from of line of Harrison comes question Bank America. Your of first

Your line open. is

Greg Harrison

congrats for question. guys, And on our Hey, taking the thanks progress.

sparsentan. are you you and the existing need of investments thinking availability you also? FSGS potential make commercial the then IgA potentially, about launch nephropathy treatment then of for the physicians about would current to approach, what leveraging to As your to infrastructure your infrastructure? How launch a also new beyond and And educate product

Eric Dube

you Hi, launch, I thoughts for portfolio, very that Greg. much our we the it for on our preparation of Thiola, treat and the the physicians already EC. community before his I that unique is infrastructure the cystinuria of with to think commercial with over turn for Thiola Travere one have aspects serve Thank And the question. including Peter, for

nephrologist. bit what to nephrologists more to talk about would Peter, investment launch. set So if And want for you that the US. look a would already and profile are relationships look with many of many little like expand how in we have the of a them we strong

Peter Heerma

thanks, And for question. Eric. absolutely. point. Yes, your your Greg Yes, to

have nephrology neurology the team & a filed rare, we we then team. So two ultra teams, hepatology force and rare we have of have more

on So about currently, calling neurologist XXXX already. we are

think good in neurology I there. we So a have footprint

that extending sparsentan for in be the certainly month. preparation will We

about the of think part I that had footprint we second to education, was that build can market With the question. your we upon. think solid a I think how we regards

want state on give if Noah, affairs regard initiatives. We that to know to see are medical don’t to with color planning you education some and

Noah Rosenberg

outcomes. there's sure especially just important Peter. education, proteinuria And you, with clear a and and and this physicians, overall Thank Yes. here, pre-launch link make medical year that between the so the and in to Greg, understanding the is approach eGFR way in we

literature I a area out think and clearly pointed to, set. of we've that's data there's in an has our that that bit on quite borne been

be really that'll important So area. one

The got help data other and and the understanding people's, And data and to both out the data regard set sets that addressed and really I on this progression Real there. and right, World ensure that area, that ensuring global generating regional focused is think, we're Evidence, building we've and how link outcomes devastating and is to questions are right that the with is. of FSGS overall again and proteinuria, disease

Greg Harrison

Thanks. That's very helpful.

Operator

is Your from Carter from next question Gould Barclays.

open. is line Your

Carter Gould

Great. guess how progress. those via can on Good of And rough guess you And you FDA, that, other us kind that minutes. communicate about for course afternoon, that, the guess, see of the Thank of we release. intend the And plans that. guys. in should just just from And haven't if year? to wait one, I if tend congrats you four can past, then think if we to press additional outcomes you. expect on LCM we if you and expect the SPARTAN really with too to how first I over we any meetings, much sort just pop-up those the communicate I learn study, what talked of the all the as conversations a idea about maybe give should

Eric Dube

questions. Carter, Thank for the Sure. you,

and up. coming alignment, we to full first minutes the FDA with very And be plans, ensure communicate our do take me after Let engagement, regard focus receive clarity would from we important our with to to regulators communication have, the the FDA. one meetings obviously,

expect second that study, would you towards And in the that this being bit little the this why so, as conducted? status our updates to really And year. planned like SPARTAN study year. half half of a Noah, you first the about of talk is progress submission and they in can that the further is

Noah Rosenberg

That's a great question.

about. large look in we to that eGFR got you understand IgAN give to at adoption proteinuria answering really again, link and a going talked about population. and question study, PROTECT population, us study that's we've And now that when So important

a these the does, it's and this on an changes layers why what Barrett as I Leicester, occurring also think, of what field. eGFR. improvements these there, leading with the it populations in SPARTAN changes study are SPARTAN that IgAN are in And [ph] helps understand is Dr. with does the who, level that partnership What are proteinuria a John to mechanistic why, cellular are us happening? stabilization at luminary

the these and but the those with we've drug imaging in other opportunity sparsentan [ph] serial kinds improves - to We've in those are densely robust apoptosis, seen talked biopsy show in it's mesangial about physiology, So is are, what physiologic that the level. we MRI, hypertrophy, also how things seen a see again, packed to anatomic of function of small a measures. of biopsies, on really working. patients, on in in and know in models, effects it's anatomy, that animal rare look able MRI we'd on SPARTAN, inflammation. to We've study, like be And SPARTAN multiple very surreal very an is it's at see the of the changes measure

and of part it'd of it's be to proud very we're think fill partnership, So a thrilled important be I blanks really great in, to and those this. a

Carter Gould

you. Thank

Operator

Your Joseph Leerink. from from SVB is Schwartz next question

Your open. line is

Joseph Schwartz

if much. PRIMARY was FSGS, the the time Thank so your very given study what Hi. FSGS, were secondary have a wondering, at far of - Thanks success in I on when is? latest right FSGS sense all, your would to whether thoughts you you.

Eric Dube

the utility and say can far, of and the community. some and recognize utility the programs we that for broader the we for the first bit share have question. thoughts, nephrology sense. certainly Maybe to feedback his would broader Noah thanks our foremost, maybe the about or potential complete, I so is from priority little Joe, a

Noah Rosenberg

to across we've talked speaks really It about. question. excellent an it's these Yes, disease that common right, states the pathway,

even you'll If and you RAS inhibition top across improve outcomes ERAs stable have on diseases. that of shown multiple look to improve - some see disease in proteinuria, states,

it think speaks I to really that. So

I think is we've that FSGS quite bit. it that's area an at, - secondary we've looked asked a about been

to robust think obviously, point, at other and that ensure focus look To will if carefully. have, get finish. completed, with Eric's that going is study, very to access But programs, our mechanisms. and I looked quality, high we and We at some done that, it's is we're pretty DUPLEX primary we've

opportunities of like sponsored with different interesting after underlying if factors. demand risk with Some I in investigator we there's think secondary secondary But clearly, we think, trials, interest, [ph] that are a hypertension. the shifts - look an ways at proteinuria many treat there's patients things the other have evidence is this. can But

wouldn't And point, benefit. offer So timing matter there well. just we that we and believe to bit a of It's there's this wouldn't a as there's the potential no reason quite of dataset. generate what overlap that want drug Eric's

Joseph Schwartz

that then Yes, one some makes another recently I Thanks. And protein by that highly comments it's intrigued sparsentan. was bound. Right. on sense.

anything patients as dose that was and - with -- in us can known be will I on a tell that And with you like may in wondering, that's there believe, expand IgA need hypothesis with make what on you the that as regard? as that could inferences case just so other of if FSGS. those or bit terms or is phenomenon, any not as high a nephropathy little far PKPD,

Eric Dube

that don't question? you Why Certainly, Bill take Joe.

Bill Rote

frank key the in the just with Certainly, level one differences of proteinuria. IgA this the and FSGS is two nephropathy, of

and an drug offset one are the PKPD using proteinuria greater values, protein additional response in in FSGS to at that rationale to patients driving albuminuria and of wasting provide and numeric, no the And while of in some at XXX the a down protein in XXX losing actually can that behind XXX, sparsentan albuminuria. exposure was patients, of to the asthma look different and lost, observe one any lot data XXX we dose we the that rationales, milligrams. of it's bound and in goes From the in FSGS are They're when a the milligram the standpoint, being With level urine. was exposure larger the – XXX with XXX high degree there's deposited a of PK overlap. enough

be large. just is So provides not the the an those buffer who XXX between It's might are to They additional difference the two patients an in albuminuria state. overlapping. significantly

Joseph Schwartz

yes. Right,

taking Okay, my that Thank helps some for connect questions. dots. you

Bill Rote

Sure.

Eric Dube

Joe. you, Thank

Operator

Blair. William from comes question Your Lugo next from Tim

is open. line Your

Unidentified Analyst

Ron with that Tim. I great the to on really rest guys. say there congrats think on really This going Albireo, John taking team partner. want is the well, over we a Hi, collaboration to of recent the Thanks for they're my for question. and and be know

expectations your to And a incorporating get up the question, your as of and our into should Just housekeeping how for thoughts models? Thanks. wanted follow we odevixibat. some think about deal

Eric Dube

We're I for obviously is we bit often of to our I'll patients you, this pleased need broader reaching have provide part to really and disease critical opportunity a fitting see Peter And John, little so But that. And collaboration. these such who about about really that. underserved. to for thoughts in his Thank talk think we very talk we'll thoughts. and the collaboration careful a are and rare us. ask our limit, rely on Peter? team to can Ron opportunity, be strategically think I on where the

Peter Heerma

for that for we for molecular for it's new on to next of great fields group. our the the the our experience And to think later opportunity collaboration Eric. Thanks, and And I very and products, fields. with years, strengthens pipeline launching question. is sort new indications new the pleased was in to quite mainly Albireo opportunity are of also and sharpen as point, few in our if great, Eric's I products strategic demonstrates planning leadership with which simple thinking us, we Yes. CINGAL our us, think rare it's, the approved, year, mean, think next about position a helpful see I us [ph] and hepatology CPH value well entity, collaboration this a But for TVT-XXX. I And launch but we're further indeed great

environment important think about capability when an post the in in particular I COVID it's we think COVID you playing. that So are

And I the so also continued allows think community. collaboration stakeholders in access our this to core hepatology us

Unidentified Analyst

Thank helpful you. Okay,

Operator

Your Gilson, Canaccord is next from Genuity. Michelle question

Your line is open.

Michelle Gilson

your taking if guess maybe expect, value you for preliminary sparsentan how FSGS strong would be might I just question. could Hi, I thanks discussions. just for immature am peer had wondering in any proposition with you that my or data, talked comment and proteinuric And you've then anticipate between full interim on having a data confirmatory change results, a eGFR approval value that's accelerated I proteinuria I the the to about questions. future proposition label? be that do two And was data? would eGFR to potential previously in guess, you if guess

Eric Dube

questions. that thanks their important, teams prepare for And certainly for and doing very of much as part Noah to commercialization. work the Peter Michelle, so the and are

ensure bit how emerging is, value Peter, access what would addressable answer the talk see renal think ongoing the reimbursement that as and proposition for strong understand in discussions that that US with we for rare don't I that proposition the value been is you Europe sure why little make a see about role a do we we clearly population? we there play in have yes, assessment? and field, and how we has with payers, both to this the proteinuria

Peter Heerma

Yes, thanks term sparsentan translates characterized. for And the value that and sure Michelle. to is if how of this your that Very absolutely. well question. in very longer And make good question, important the

the December, innovative, kidney I end-sage think we to in delay R&D sparsentan, disease. towards that comes from the At several motivational making components. day spoke ability about

talked of quality We have our we in And potentially. like also proposition modeling. about and you safety component integrate then sparing how steroid life of quality the life perspective,

like his to referring end-stage was showing you Barrett remember in R&D I he disease. Dr. just where translated on delay towards level some XX.X proteinuria, day, our into analysis XX% data, if of know showed patient kidney actually a reduction don't So year

work FSGS. same we So the are now for right doing

value patient offices. to translating data, translate physician to its data also directly base have will we of level but in historical then it So

approaching So we that's proposition. the how value

for that's We have to the how payers. discussion. plan we dialogue US Eric’s And continuing price with yes, point

Michelle Gilson

for you, Thank guys question. my taking Okay.

Eric Dube

Michelle. you, Thank

Operator

comes of from Your line Maury next the Raycroft Jefferies. of question

line Your open. is

Maury Raycroft

thanks for progress. Hi, And everyone. taking the my questions. Congrats on

check request an I post-close from in wanted FibroGen. one, First with that They just a to an got update happened AdCom. on for FDA

I in said on the was based think past. FibroGen unexpected it what has

comment your on and the go? and just those and interactions you what recently, if you've update, FDA did So thoughts unexpected how whether are interacted with could wondering

Eric Dube

Bill we've about, I've share any FibroGen their much on his have and comment questions. bit very for preparing is the discussions the that team can't submission see plans a What you and detail program. wouldn't thank I Maury, place with to for say our I'll little continue had our and how and FDA, So about not have on seen any review. and to is details specifically

Bill Rote

sign Certainly, - that look we'll first Subpart the sense opportunity have set coming of to interim all legacy may for there of have a review. half will once we up as overall that looking align the data or study pre-NDA your in the detail, to will to and meeting be current interim be of Eric evaluate had make point, panels At need well the be public. approval. that stated to on objective communicate accelerated to how as the be at, data plans and in about sure we've agent's we, it's out for a discussion their us earlier, meeting The these for year, first H may in on it to will the And data we question. and present and minutes the data. not then meeting And that

Maury Raycroft

Great. helpful. That's really

taking my questions. Okay, well, thanks for

Eric Dube

you, Thank Maury.

Operator

of Your Liisa ISI. from Bayko next from Evercore line question comes the

is line open. Your

Liisa Bayko

rate sort had little the we placebo maybe the reflect Could Phase change, to what which study, to, was placebo in the XX% that Hi, in data X. but kind there. first for you've will this actually date sparsentan, about in speak on study. of in close the change not was just Thanks now it And the to had X% a more, the you then a a to original question. went bit way, time of up for taking in

curious. and about had on so think sorry, do far its the And Thank anyway, helpful. And you've then just feedback why have kind you've own gotten we that curious irbesartan, gap So my if any – that. there? any I other on see you. your kind just be placebo, thinking not of of, of up thoughts, data but

Eric Dube

trial the belief foremost, share effects But the the data, within and, ask discussions perhaps certainly, conducted his FSGS. that it seen have to contributing Noah in bit around I at support And to the I thoughts. Liisa, about for Subpart data why powering, results over I’d being this might but thanks a tremendous and think largest incredibly we've we I’ll and were that field saw And little that's within sufficient I H. the XX-weeks, our I'll for, we some FPRE thoughts But for Noah, that nephrologists ask turn before the strong, say, on questions. one with Noah longest think our to two, the his first to seen. that. we're share a we of have treatment amount the

previously, go the Phase X. that to little beyond eight very weeks Noah? in information So on had we

Noah Rosenberg

we X saw, that the you're to if think just I questioned, achievement period, at point, a somebody had the for FPRE. referencing, you the Yes, X% double-blind weeks, Liisa, look XX% and we data Phase at that DUET Eric, study, eight where versus

take largest we're to was which said, And of DUPLEX terms the would you statistically manner, which data was longest a a inbounds assumptions. a was the within the endpoint with weeks, what a field. it's nephrology and and the in progress, insight provides or something we've really FSGS. DUPLEX about study week [indiscernible] drugs our the lots is just to I and want to the to know how With powering the the DUPLEX, that consistent it, the in comparable those relative we it And, of almost have – two XX validated is, for step back FPRE, FPRE, now know XX% week this certainly, profiles irbesartan, Eric between with outperformed showed likelihood relative encouraged We XX% to XX that which likelihood the XX And really didn't of to expectations then reflect in got of achieving greater linked was incredibly by safety weeks. mention a drugs. to And it data. and data it is meaningful clinically eGFR important that but progress community important they're groups. stabilization. been, talk So of and significant how on achievement week eight has consistency we speaks out when And how I if and you tells -- you sparsentan and in think and insight the not only XX the of perfectly So point, which kind of this tracks go in remarkable that do

So proteinuria reduction field. generated sense, strongest in has the been that in this really, a is this

you from it's non-immunosuppressive how once for If long think oral well I treatment. And need, understand huge with term because works about think a data this We I day, a through well drug unmet just safety need it's think set. therapy. standpoint. there's a fairly a piece, huge X critical characterized Phase it a And DUET been that's a our an

think I excitement. really to what has the that's led really So

Eric Dube

that I add a consistent the feedback is is to that results with only And other we've eight while there thing thought from would this I that that is from leaders was not also think the the greater practice. heard are weeks XX clinical some of increase nephrology weeks, surprising. but

themes as we're that's of the from that think hearing Noah that of consistency on see that this feedback this between Phase profile I consistency X, Phase we that but incredibly of one I So to And KOLs. clinical X sparsentan encouraging. think is trial from practice, mentioned, endpoint, the,

Liisa Bayko

on And that? know that noticed a conferences week, there's or I going this the up updates there, anything CKD details later three the far, like I you're trial or coming and include giving a thanks. data talk so Okay, will any

Eric Dube

not we what an of additional It and know to will presentation will any provide publicly it to what No, data. we date announced additional be have date.

Liisa Bayko

set? And you about in maybe is TVT-XXX, - data, thought Thanks. we and you. expecting this XXXX. talk we that that's should Thank just, be slightly delayed, looking final but were And what we frame question. bit get I data just then data if great. a for could this earlier expecting up, And Okay, in could whenever is - trial my little you then if

Eric Dube

Bill status progress. for continues I'll a that little share to about this bit to ask Okay. we'll looking And year. Thanks, from And later program Liisa. be the and what trial the

Bill Rote

Certainly. question the Thanks Liisa. for

to in right strategy And we're going or or have homocysteine. be medicine said, plasma to what that see we we're of study And to going forward. from primarily selection we evaluating year, the develop continues advance. dose, the the want preliminary across doses, this effects different be regulatory at the working to additionally, Eric of expect reductions expect to the do going data As to looking to the

caution with I like and you're the than is - smaller study, I DUPLEX that - that of in think greater length our a just some with the something impact the hearing think is impact, reasons. potential different sites

the And a Additionally, broadly manufacturer. we COVID with molecule. quite now opposed have manufacturing right to biologic contract as a this world in case, vaccine space is the small in biologic impacted

to While in track, contingency continue it's we that - we an monitor. have and plan place, we are on

Liisa Bayko

Okay, thank you.

Eric Dube

Liisa. Thanks,

Operator

Your next Chico question line from of comes Laura the Wedbush from Securities.

open. is line Your

Laura Chico

much clarify. protein Thanks taking very to that's just with - one for the I question. the respect And to to on binding. wanted circle back

that other dose factors making there? versus kind perhaps, go And follow think purely properties, protein that the wanted in in the birthday. with dosing only to is to XXX And make you the and use the up earlier in clarifying So, well, dosing permitted I and of XXX milligrams. I up PROTECT, terms perhaps just decision sure happy came drugs into there of milligrams, I but to PROTECT FSGS in you're on trial excuse understood, lower of process course, then question binding quick Laura, based for or to to me, are DUPLEX one mentioned decision

continuing spent hand, the about study be studies much. two should how While wondering with year the this results R&D continuing? very we just DUPLEX we pivotal on have in going top is we've to Thanks cadence obviously, line and be line the the thinking

Eric Dube

Laura. protein very the to anything I've mention missed. provide I’ll briefly binding that about ask Thanks, Maybe and Bill

and dose S-curve. that of I effective I proteinuria XXX think FSGS. of in we And We quite to, response into you're the to efficacy. be aspects not is more top other XXX one of doses the see is the compromising And that and albeit study, getting that both alluded the came DUET much in Bill believe from the we that is sigmoidal at XXX as think close that reduction. would play do are -

decision so important to some of And select. making that what about component the of a was dose very

protein So degree to efficacy yes, serum further that but also was it of on protein anything binding, want levels, the about was it about those that? Bill, add you'd and with doses. conferred

Bill Rote

that's think right, exactly I No, Eric.

Eric Dube

Laura? And Okay.

Laura Clague

Thanks Hi, Yes. for Laura. birthday wishes. the

XXX to have the H expenses we've R&D Phase your expect studies R&D the technically level, eGFR the to it In maybe can where to for week, studies still think we more our And the trend run of with start endpoint. quarter X, You out, over about current been expenses traditional Subpart confirm the to increase see a lot downward. describing. reasons could out with case reach once pathway, we

supply program chain. In addition in that, new our and also be TVT-XXX, commercial for up we'll to scale investing with our building

those that in all happy time. are be at investments this significant So will point

So to modest quarter-over-quarter some current we level. R&D compared definitely increases expect go in as

Laura Chico

very Thanks much.

Eric Dube

Thank you, Laura.

Operator

this I am I like showing to turn no time. Mr. would questions further at now back Cline. conference the to Chris

Chris Cline

week. you, talk future. the XXXX XXXX. Thank We Katrina. afternoon near for you, exciting all Thank this many the you Great. of and providing joining today. our in outlook have hope updates call I to This our us in our for accomplishments great about to for a rest forward look everyone concludes

Operator

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

disconnect. You all may