TVTX Travere Therapeutics

Chris Cline Senior 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
Lauri Scoran Jefferies
Chris Clark SVB Leerink
Lina Kaminski Canaccord Genuity
Christopher Marai Nomura Instinet
Tim Lugo William Blair
John Walden JMP Securities
Call transcript
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Good afternoon, ladies and gentlemen, and welcome to the Retrophin, Inc, First Quarter Financial Results and Corporate Update 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 now like to turn the conference over to your host, Mr. President Relations Vice Corporate Senior Cline, of and Investor Communications. Chris

Chris Cline

Thank everyone, you, results to call. I taking hope Bella. remain this Thank your during join and time and all to the Good update you financial Great. afternoon. XXXX this afternoon, welcome time. us for quarter Retrophin’s corporate families and you well first

Chief Noah for Today’s Research us for Dube. join Eric Eric Peter Executive Officer, the the remarks Chief and call prepared Dr. Commercial will Dr. President Dr. will be Officer, our led by Rote, Medical by our session. Heerma, Chief of Q&A our be Senior Development Vice Rosenberg; Laura our joined Officer, Bill Chief Officer and will Clague; Financial

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

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

the Please forms factors statement see the as on press section issued SEC. the earlier filed well as in disclaimer release our with XX-K XX-Q today, and company’s the forward-looking risk

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

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

Eric Dube

you, and afternoon. Thank Chris good

a enrolling XXX performance to by yet nephropathy, strongest commercial execution to of milestone and this critical of in momentum great sparsentan during DUPLEX in enrollment quarter. organization. our translated It the XXXX. IgA advent trends and PROTECT DUPLEX achieving the COVID-XX, and our pivotal organization to to first the to prior start for studies FSGS demonstrated strong first our the and also patients notably translated Our of

in record in to the of with year, and and consistent our therapies we nephrology approved reaching rare products times spread demonstrated lives quarter first those living Later continued and track difficult the of that further patients patients are for the our the communities. with the disrupted rare COVID-XX our for deliver world. everyone and first the We of people these In hepatology families especially disease. the quarter, new to ability recognize around pandemic

to While it adjust and our goals. working, has our has of our changed us has it this required not operational ways pandemic and financial not strong altered foundation

pivotal upon patients commercial support high-quality while in in our continued for we of to And approved and and focusing our our to in We two us of make conduct potential and position are progress studies simultaneously are sparsentan, building maintaining in for organic continuing completing if approved preparing to capabilities are order maximize parallel, on products to enrollment sparsentan’s existing submissions. ultimately growth future. the able be regulatory to

we’ve evolved aligned on the COVID-XX these continue goals. that it today the Importantly, mitigate us impact and advancing allow as pandemic, of will best priorities to we believe as has the towards organization an

the wellbeing behalf on time, this flexibility of by can health our employees the safeguarding and our of we safety, focus continue We continue and during and patients. as support well to will work support them as on wellbeing providing our employees of

translated shifted remotely employees that continue and gives adapt organization’s And our we beyond. to possible. Like home. dedication us, great and of ability this pandemic our our together I’ve confidence evolve resilience, working me deliver proud very and on to far, will mission thus to work environment having most for have where which of during virtual nearly companies, from a all we been to has this

continuity approved our products and of to we this ensure have studies, our implemented receiving heightened safety, procedures time. access or patients For in care participating during

building on as focused ongoing have contingency we years, result to pleased a several report for am efforts chain of like a with uninterrupted of been today. therapies supply to I plans supply that this. and flexibility approved investigational last and has these events the Over our

we we of months pandemic’s or goods ability for today, XX treatment of have in provide in access worth ready confident all products. are more finished continuous to to As state. current our the And

Our clinical of sparsentan have the challenging studies continued conditions. despite

goal EMA key for closer during of XXX for approved. We enrolled recent quarter the and within working sparsentan in medication PROTECT. DUPLEX continuous first of patient Achieving delivery milestone and us realizing the paradigm an to especially effort was COVID-XX maintain our are and for potentially patients DUPLEX shape if safety, critical endpoint to step FDA data the guidance in ensure treatment to brought quality one regarding data, a that FSGS

with been expeditiously pleased from integrity our of in to results to and and teams partners’ the the measures the necessary of the preserve I’ve for pandemic. disruption studies face implement efforts data our the monitoring

to order staff the has centers slowdown studies. in clinical and screening enrollment exposure study restricted recent well coronavirus ongoing trials augment protect of to patients you possible capacity in access cases, response. the in unsurprisingly This both is a to As across in been from aware, and for are COVID-XX site our clinical and many resulted

at the what still the of are believe upon know timelines we today, beginning Based the we year achievable. provided

were yet and timeline. in our enrollment impact know not to if it do impact the COVID-XX could full an of extended occur, slowdown we However,

working and day when closely clinical activity, are each learn and site We the where to and physicians, more support appropriate. sites, patient with CROs, community our

leverage and instrumental steps RESTORE footprint trial in the at completing will position clinical PROTECT DUPLEX, to as have ease. our also enrollment trial accelerate time. we taking been execution appropriate to rebuild momentum the clinical towards on to be when existing pressures This We system our in be healthcare

increased this business, our we Care to the meet and report has and I receiving Hub been of today; able operational remained are commercial am this existing our patients needs our access For that time. patients ensuring that are during during support time. our they need has to fully the proud Total

encouraging patient visits initiate to during is diagnosed of it patients do need receive subsequent continue initiating could be fewer also that during we treatment, that number treatment time, while treatment the seen the pandemic patients this anticipate and reduce the months. in patients they We have new

Importantly, virtual with they to we’re support healthcare interactions, the so engage information. necessary continuing field-based that and through have teams’ providers, our

We year. are and the facing. disease this dynamic the are challenges society, monitor continuing our to previously and our could communities industry, the certainly that it product the especially, for rare this currently our impact extraordinary recognize growth expected on portfolio have approved We

through needs and beyond. This remain to will understand unmet COVID-XX also pandemic. within We these why that resilient the our pandemic will is organization we beyond continue work this the remain communities as

Noah? over now provide he we me are call Noah, advance that clinical to steps on the Let the so our to can turn additional studies. detail taking

Noah Rosenberg

good you, Thank afternoon and Eric, everyone.

mentioned As in first pandemic quarter, momentum global and and the impact we support impact clinical to patients our measures during important period the these near-term this the COVID-XX DUPLEX to with started our pivotal PROTECT and and year in implementing teams’ Later sites to our to earlier, the began studies shifted studies. clinical trials to sparsentan. great on priorities mitigate

deep a level each of support. as our studies for sites we’ve setting that for understanding individual visits, The into well a in we of enabled the as has broad disease clinical needs of with the site level the visibility rare right patient these connectivity implemented provides network provide

study dedication and with are sites, principal We of treatments contact all continuing reminder their CRO in serve important need as our investigators, of close the nephropathy. and for partners FSGS and that significant IgA new in an

us five help that best navigate Their the collective we believe pandemic. institute insights will following have helped priorities us develop an this

designed patients a technologies patient ensure to we major to recognize such remote support safety paramount. is for the as sites with patient far safety. telemedicine patient monitoring and flexibility and make study been we’ve to decision team pleased during as while We have leverage needed thus adherence safety. First, remains the a ensure and with clinical plans increased to this need time Every as

is providing continuous supply. Second, drug

We are protocols shipments ability patients control arrange shipments making directly to and blinded of to the under necessary. for if clinical to have sites supply extra

are key approved to and is endpoint FSGS Third, – and critical safety studies. IgA for approved potential DUPLEX developing first The protecting our the PROTECT therapy for data nephropathy. studies and

a the we will to date, plans. data motivation patients thus We with both we’ve seen study and sites monitoring and and adhere support a To continue readout. lab across visits study and are seen far, maintain to strong high-quality to prioritizing have results that efforts

studies clear FDA documentation of taking many as a actions the is taken EMA and time, ensure clearly clinical documenting steps this we result patient Fourth, are and the to to during of COVID-XX, data these. aware, adhere and we to as you integrity guidance are safety and are provided of

the ease. in pandemic enable steps to us regain Fifth, taking studies we are our that divisions related once strong enrollment momentum today

for This randomize but footprint activities clinical broad and many you XXX some of continue in have supporting studies. and than resulted slowdown a meaningful patients, uninterrupted the will allowed recently. sites have regions PROTECT to continue DUPLEX these we recall, in restrictions to a global more As with understandably, is

we control to and clinical practices been activities in pandemic, candidates, sites continue at keep our implementing to we the leverage have to to position While magically in the footprint to trial or the appropriate be restrictions there cannot be broad which length, will we activity prescreening at able reaccelerate identifying time. are

enrolling we studies a the milestone FSGS. brief achieved XXX provide DUPLEX now sparsentan in March, with DUPLEX. our pivotal early on critical starting of each for I’ll of patients update first In the

will the DUPLEX study after interim you analysis first a in the patients treatment. of XXX provides recall, prespecified these proteinuria of protocol many to weeks endpoint efficacy As for evaluate XX

this pandemic study for as in are patients and approval framework expected we preserve have the to the filings Successful XX-week submission the visits and follow-ups Europe. and site of accelerated basis despite plan proteinuria with serve pleased to been we is within far, for regulatory working Thus following ongoing achievement of conduct. the endpoint the U.S.

of to that in achievable. is continue next readout We top-line quarter year first believe the a

of However, were the slowdown extend as delay COVID-XX, a it result top-line to if could the in readout. recent enrollment

the time at We you will update if that appropriate materializes.

Turning our IgA study, X to the in trial clinical Phase nephropathy. PROTECT

reduction our there and of sample increases evidence a confirmatory eGFR, IgA endpoint nephropathy. our approval. between specifically probability applying growing during study in latest consultation body and the this current mentioned adopting weeks treatment As support over adjustment in update, with improvements our We the of for design patients. learnings were has the in we to been the as we believe After link the to full XXX XXX eGFR of measurement last size to increasing proteinuria FDA, total and

treatment primary change patients accelerated data with remains of XXX these XX plan our endpoint remains unchanged. proteinuria the first after and pursue of in to filings the Importantly, weeks analysis of unchanged

and patients earlier, enrollment total proteinuria first of making progress continue strong initial XXX believe in and top-line PROTECT XXXX PROTECT in we achievable. the good to half continues XX-week to prior analysis. mentioned response, enroll the readout proteinuria are is Eric trends the COVID-XX to in patients had end we XX-week enrollment seen the As support to a that we analysis of

slowdown result However, timelines. in to recent enrollment COVID-XX, it if were our could of impact as prolonged on a have be an the

will April, that both update for end data the meeting. DUPLEX and We at at PROTECT report to studies that these committee proceed scheduled our materializes. you completed if pleased planned. as that monitoring third both the independent appropriate Notably, to I time the recommended of am of we DMC

advance supply, to So pivotal documentation. and enabling COVID-XX, we to focus continued presented safety, integrity studies the on both clear patient data with despite a by of summarize, our challenges preserving continue

we in into being official While slowdown and continue a we regain working to time. we we footprint our our confident our studies; from learn we recent high-quality in are trends, come And to months. patients the see more to steps leverage deliver the forward taken have as clinical have we position to enrollment seen diligently providing organization and updates new coming the studies look to data appropriate momentum us at in an understandably

Peter? Let turn to call me Peter. the now over

Peter Heerma

demonstrate Thank we of to as is an the to in rare saw driven disease needs the years. launch with identify first new across in prices plan product initiation you, and nearly of Noah. our parts. understand approved commercial ability a organic $XX.X quarter, organization This execute patients a formulate growth and continues In have million, basis five treatment not increased we by all and which sales resulted new diagnosis three net basis.

patients in demand Notably, earlier for is regimen. in It’s an that with need consistent cystinuria community. of have and indicated we flexibility insights our additional treatment for the strong underserved saw This EC. the first THIOLA research quarter,

first the in the higher expected line was expectations. we our quarter, to in of As the in experienced the Year. gross business, beginning New discounts The insurance by driven shift with net research our in

second the will we in beginning return normal As levels anticipate, quarter. it to

million an coronavirus see this increase we In that the early of began in million in in likely would in patient This of has approximately slightly evolving to seen second the likely request some we response as compliance, to revenues pandemic. during We that March, re-sales first as quarter expected in to not $X.X go-forward contributed $X half revenue reduce subsequent well circumstances. estimate to quadrants. have for could increase normal

the receiving to access response our partners teams to working patients ensure the coronavirus, During diligently and continued for and support therapies. are approved our

including maintain stability proud and this unprecedented to support continued shipping taken been of time. patients steps onset for to inventory pandemic. of have levels appropriate this have of the team’s We our needs delivery flexible continuing deliver our I through during options incredibly initial

HCPs. THIOLA for Our interactions sales transitioned virtual with to have teams and CHOLBAM exclusively

engagements teams we solely for worked we a have engagement method have Given seamless solid small years. many many relatively have of geographies for made States, providers members healthcare and the part that transition of how and to This the this in on with broad virtual with team relying [ph] core efforts. our have these seen been cover we United

we current starts. patient change rate ahead, physicians how coverage with fewer hardly As monitoring may could insurance new and our we increasing impact base, patient look patient closely are visits unemployment

relates COVID-XX those a have lost are to not been patient current we’ll full for do that our as prescribed impact has the it it that base, we our As anticipate already products. post to-date; new pandemic

earlier, prioritizing delivery been treatments. date, and to access As have mentioned we successfully of

that providing Care come our operating Our depend Total the to is on. uninterrupted, Hub have currently patients support and

have we in we far, this change monitor dynamic. coverage, continue but payer a patient’s the seen to insurance thus not mix Regarding will

The terms new for is months continue to in products In strong impact see however of we identifying additions April. future all unpredictable. currently month across patients, three patient of the

we a their physicians As fewer COVID-XX. result anticipate patients of will as visit

yet our have, not impact know potential any, in to growth do may this full We the XXXX. if

currently stakeholders together confidence with continues HCPs times, This our treating we navigating and of to the to robust are to other that diseases. ability of an patients commercial foundation state with continues uncertain we able in living While and demonstrate will organization rare here the identifying, if and patients launch supporting work closely give us to approved. a be pandemic degree high sparsentan we nephrology reaching continue have to current in

Let call to me turn the financials. now over Laura the for Laura?

Laura Clague

Peter. Thank you,

a portfolio $XX.X XXXX. quarter a XX% for expenses and On non-cash of grew net of the XXXX. loss million, income sales from quarter, XXXX. first non-GAAP After for million. same product adjusting GAAP million over for were first first our the net expenses During of $X.X commercial $X.X a basis, million R&D income tax, quarter net we in reported $XX.X GAAP a the reported to We of increase period the

compensation Relevant $XX.X $X.X amortization. of and same to development period quarter. basis, to in XXXX stock-based first largely fosmetpantotenate for an non-cash expenses on program. of the The quarter the is discontinuation expenses the adjusted R&D were decrease included attributable million first for compared the the million

administrative on the period of basis, minimal increased million non-operating first a non-cash and largely first adjustments $XX compensation the bond were of same one-time to as and million. a amortization. quarter consisted The of GAAP adjusted XXXX on quarter the consideration the approximately $XX payments. We million and the a expense sales increase quarter for basis, in $X.X in Significant debt depreciation during fees. an professional for quarter over were attributable milestone used expenses result of stock-based cash expenses million SG&A and is interest selling co $XX $XX.X million. in higher general incurred contingent for compensation and

be for from of of net This preceding the be to we paid resulted Act benefit back installments and during quarter, CARES taxes. losses this which income refund to XXXX operating to carried tax an anticipate a to legislation, will million. and We taxable company during the generate benefit $XX the years provides XXXX. recorded income previously distributed refund

and $XXX.X ended the foundation million and of cash we of cash financial as Importantly, March equivalents XX, with solid a XXXX. quarter

may our the beyond capital sufficient that studies in impact disciplined we COVID-XX from readouts the operating we to our to ways difficult hand operations fund While of sparsentan. working, and remain use X phase expenses our of predict our our we as on continue cash adjust and of be mitigate believe will is near-term our of to

Eric? the his to now call remarks. Let me turn closing back for Eric

Eric Dube

Thank you, Laura.

to continue the we we work, presented navigate As challenging by pandemic COVID-XX, but why. have we not how the shifted

wait and organization We dedications continued for pandemics, remains pursuit of more our been mission and our do caregivers. diseases has not steadfast critical. serving its of our patients Rare and never

and to We a support foundation remain unchanged. goals our financial our operations have strong

of of treatment IgA to first on focused and goal our FSGS the development support nephropathy. continued sparsentan are We potential for delivering approved the

we caused confident while if commercial strengthening patients reach by with am the will our the to approved. us new enrollment capabilities PROTECT conditions when actions and accelerate ultimately also and taking And employees I data studies. deliver we ease from our our quickly patients mitigate DUPLEX work the potential the that and are to approved high-quality disruptions that sparsentan’s maximize pandemic ultimately, to protect position products to will

stronger I we for and thank today. each the our deliver Finally, support am outlined like our company. of of the focus pandemic highest on dedicated from patients ultimately, to the members their level priorities to Retrophin would COVID-XX continue continued emerge team will that confident I as with a

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

Chris Cline

line can Q&A? we the please Eric. open Thanks, up for


question with Jefferies. Our the [Operator line Instructions] Raycroft comes Maury from first of

now Your line open. is

Lauri Scoran

Maury. Hi, this is on Lauri in for

THIOLA by gen on than was sales Can any of a and proportion have EC versus is by seem specifics proportion better couple driven you versus commercial pricing volume I THIOLA? prior provide the questions, what So, driven the to expected. what do

Eric Dube

question. you that take have much for I the very don’t Peter, you one? Lauri, Thank why

Peter Heerma

for the you Thank you good. Lauri Eric question. Very and thank

we five – lot of a last the years, have last the over increased prices. So,

in XXXX THIOLA to as growth well. basins in the XXXX, you patients the quarter first continue where the we in CHOLBAM. quarter was And it the new So, strong see that new saw by building as that includes as additions quarter solely top It’s on we of like and coming of on into growth, EC that first well first of saw the quarter saw THIOLA, mix. the then great both organic we

Lauri Scoran

happens you. And would if enrolled into cannot I the then kick, still drop becomes I in can that patient for you the of see. XXX come have Thank go patients to a basically studies, the FSGS you does – what not, for specifics out?

Eric Dube

Noah, certainly. like yes, to Yes, that? would you take

Noah Rosenberg


state a some we’ve continuing Let satellite closely patients guidance me very current focus earlier. and of as sites locations. state’s are to said, able drawing the a sites. on study not that, with contributions ability first are and very safety regulatory to the the suspended to conduct to on been maintain and pleased the are done this to with with I following carefully nice integrity site’s of able a come the priorities trial some In maintain local pleased based and said using conduct for with on There being regards the conduct cases, We’ve the I labs we’re of very job to sites. we’re

which the condition. In improve they have soon as if feeling Patients are better then develop and they of COVID, address drug as protocol off that. potentially COVID-XX, protocols actually and drug come go special obviously, can develop terms to back on within their we COVID-XX,

your addresses that hopefully, questions. So

Lauri Scoran

Okay. so you Thank much.


Leerink. Schwartz Joe Your comes line SVB the with from next question of

is now open. line Your

Chris Clark

of is from the insights talk you afternoon. Good or have do compared to in any degree sparsentan for about FSGS. Joe. data? Can they on you nephropathy, Chris clinical IgA you Clark How preclinical reduction This from proteinuria think

Eric Dube

you. thank Yes,

looked phase there. do FSGS certainly share databases other IgA our bit in and the and nephropathy, data a can areas. you existing we with we’ve at sparsentan about have not perhaps differences Xs Noah, on little So, from potential

Noah Rosenberg

of there do there’s very again, addition clinical I population of the think that reduction similar got slowly well reduction. precedent, data saw incremental and regard along same showing rely preclinical top clearly to IgAN, DUPLEX a in we’ve the additional does Yes. blockade on some you proteinuria. provide of with on lines mean data similar I to is see, it’s that endothelin study what is expect to data for as of benefit We there. angiotensin the upon can terms the you we as and what inhibition

the hard it’s So, are. what differences say to exactly

a below their do I one of we range overall, similar reductions would recall, you to add UPCR patients and say DUPLEX on terms in I similar think saw in would But and both. saw reduction. see were who probably in thing overall was if in you above

confident data have and fairly think that. we’re So, I that’s in – I the think we that’s,

Chris Clark

you Thank much. very

Eric Dube

thing Thank disease one the is you, Noah. patients higher exhibiting state in of Chris, levels FSGS that I that oftentimes and are add would on itself, just proteinuria.

may which because works there’s and that what mentioned, of no so into the of or mechanism is the a those believe. to expect may But we we sparsentan effect, And both mechanism, consistent see play the both not ultimately, in disease we in see. consistent

Chris Clark

Thanks, Very again. helpful.


Your of the comes from Canaccord line question Michelle next Genuity. with Gilson

Your now open. line is

Lina Kaminski

for this Hi, is Michelle. Lina

Eric Dube

Hi, Lina.

Noah Rosenberg

Lina. Hi,

Lina Kaminski


a wanted just maybe, broader bit on FSGS. on sparsentan, So little

maybe, So, you protocol patient us tolerability first or the patients with how many sites article with protocol XXX if you XXX be you saw use the how question that this many sparsentan drug using that is, about guess phase the And the to downtown to that now downtown patients, rated regards that, I and would can if X, then… the phase under in would for study? X, are expect in versus you you remind

Eric Dube

Yes. Lina. you, Thank

your Sorry, second question?

Lina Kaminski

I okay. answer. that follow Thank after it’s No, with up you. can you

Eric Dube

you. Thank

the designed lightheadedness XXX, or you actually study, XXX referring around Now, the symptoms patients milligram we XXX, in is saw say, and with And to had that we that’s XXX address what And the we I what why dropping, XXX a to started way designed study blood result, mind back designed, and to why we XXX. it as the to test patients some The was design. is DUET were to step. there’s titration the so think and with I don’t intolerability study a question the then drop the the some three two-week on you’re versus pressure consistent had referring weren’t XXX. really DUPLEX dose. able adequately tolerability,

So, the the to and lower on weeks they’ll two if start patients higher will dose. tolerate, after titrate they up the then dose

achieve in drug considerable can We XXX number I of say patients that stay that effective you are that expect I And milligram to DUET much hopefully, the XXX dose, works there. to is I the and recall well, a dose dose whether going but pretty say, milligram able that’s be the as as quite and would addition an if from it’s XXX XXX. or think

we of but the feel think up we So, pleased would with pretty with and as the in have comfortable very chance strata we be XXX, XXX at a we current XXX effect well. the showing to good titrating

Lina Kaminski

Got that treatments sparsentan it. in you with where in clinical trials, talk see of market and do know, of different maybe kind broadly then on different the a and can sit FSGS Thank little you you. Thank landscape? And kind you more therapies bit you. on

Eric Dube


What look the the XX% the study, U.S., is from at with to study, if study that of feel the patients were that anything a studies the an not XX%, certainly So, the of that, the numbers further. We off that is treated broad in are are patients today ARB. FSGS this do DUET What quite that we and conditions progression I’ll Noah growing an actually available injury how are ACE to see patients scarring And over glomerulus. the in all And going these of the perhaps the know because over these we DUET is degree and control an start proteinuria the from the currently that label, then what went is likely, Europe. is other an on within unfortunately, but to very at we the – or and that prevalence drive treatments and ARB. that free FSGS see XX,XXX slow many with patients there or also into also effectively consistent add ACE currently do disease. patients

the up it would the be role, at and not from ARB common you’d Noah, may approved patients to of and but And is to understand that something disease get we hope an add then safe the future play. see their so certainly know this is are going stepped of sparsentan FSGS, that of that’s clinicians with remains – that for treated there steroids, that or these largely or his is be this a Reduction work is some become also team patients be sparsentan effective, role standard whether the believe proteinuria some there we on use and greater. such of but if really patients Peter it is therapies role? of that and There seen classes care how ACE very would started would treatments other that as sparsentan an the treats pathway treatment first are We use. how and and immunocompromizing. anything physicians in to are that to else quickly other of like think to the the doing replaces we to hear consistently

Noah Rosenberg

Eric, Well no could I two are said, there for called add if just I to reiterate. points therapies landscape. think one, FSGS. Number Eric as me just he approved

think the that got are a patients, great of I XXX we’re of have this in critical. safety example emerging, therapies compound many terms we a in proud think area. are all, aren’t the established really who game at have who large DUET of in the is over yet that safety to I this phase there off and Number draw two, this space has really stage been that have other that database therapies, sparsentan data is that, really and only if at for in treated, very the X

Eric alluded many safety. around were those them There are concerns in classes of immune-suppressive.

going to first reason we can sure the want just with So, out there we’re are in these to again, see. there’s make that me we But believe position therapies as say, we wouldn’t that the possible no and patients, that position. complimentary we’re we that as many let at, therapies say sparsentan for that be

Lina Kaminski

Got quarter. on it. Congrats Thank the you.

Eric Dube

you, Thank Lina.

Noah Rosenberg

Thank you.


is from Nomura next line Instinet. of question your open. comes Your line Marai with Christopher now the

Christopher Marai

if you’re Hey, wanted that of taking comment switched with quarter. COVID, the could ask more hasn’t And versus that That thyroid THIOLA congratulations comments easy. I in highlighted compliant? performance new I of the how sales. Is questions Thanks formulation you Thank is toward related. to through, good COVID strong to the seeing have is and afternoon. on seeing, on respect for you’re enhanced those, comment, with your who pull it been course, And had I formulation? the know enhanced wondering the on acid earlier to to or is much products that. did then to benefit you bile was you. to it that the respect compliance in compliance. or if due you

Eric Dube

thank you, take right. Peter, to Chris. want this you I All one.

Peter Heerma

Well, across for saw consistent we the you Thank Yes. questions. all three all, growth, the parts. first of

So, continuous product to patients the ability lines. three for all new identify

I was a question growth. it’s With think an second question. on that driver the compliance, interesting to for regards your

think speaks also well. increase treatment of due numbers. started broader specific on half that comment although and then to of to behavioral to start EC. early on is an And I an to across see early see compliance still it’s I with as It’s days, in too there all impact the start – second debt compliance like adherence is we the that concept question we to COVID. and March, compliance see a lately of in addition the think products components it But we to to of

that have In the to from could here patients additional particular times treatment day. compliance. on these the the for you a have an element be that home, in TID imagine days, could more patients want middle so hospital stay impact And And cystinuria, at can a as home more take ability like treatments treatment especially being with is three EC being that at well. THIOLA to their away

So have an – that on increasing could compliance. also increase effect

half likely question, likely second factor, that saw Then addition, your increased to situation. So, in EC. compliance due the to of through the an increase we the broader also COVID

Christopher Marai

really helpful. That’s Okay.

Eric Dube

drove impact expected be of more one of these where saw for Sorry, see ask and But that in of shipments compliance add probably these THIOLA let also conditions. thing pull just that know, as you CHOLBAM both that’s next you that with before might the drugs a me more well. as of question, some that. had forward We did THIOLA we

to interrupt ahead. Sorry you. Go

Christopher Marai

about and the impact you have XQ a impact you helpful I given I look perhaps do was dynamic in how March your follow-up. was then I was increase in potential and continue quarter half QX and I just – at curious of compliance benefit generally in second emerging it that second the you’ve this a that will that of seen Yes. COVID, or the and through expectation guess is very saw

Eric Dube


Peter Heerma


I say think true it’s to that.

slight As the half I’ve in second quarter. into we pandemic a see, to mentioned, like started translate complaints saw the effect the March increase of when how really second is there, they

to early too it's say. think I

think I EC think with the EC, greater I flexibility patients. allows a of for

slight it on So couldn't there. an a be could expected be there that compliance increase

how it's to early too that's what to think to I I the call quarter. aspect second think COVID; of into translate we start particular the see

Christopher Marai

I slowed have I And has you great. to I’m pivotal respect to with how do guys in to And and sorry, you that been respect pivotal going impacted been different trial you wondering up initiate to and to that's just finally respect Thank were looking – CTX impacted. that COVID. a at was initiate Okay, that with or sped BD, just potential being down with may Chenodal opportunities know I or trial then you. what with had many guess, then how and

Eric Dube

you, Thank Sure. Chris.

to the study, to we screening study. of with We saw are this RESTORE. regard that that and Chenodal CTX impact initiate with seeing and enrollment also similar DUPLEX with So the did PROTECT, and we trial RESTORE the that is

to that this at early able too for us it's but point be say an is for timelines study. project to one, I'd So, it ongoing

And regard business I not then with sped would slowed or say to is this down. development, up

leverage that for We to for as remain footprint that And the on focused that are we continue for we number that strengths commercial. would have rare priority and still development and the the us. clinical assets within both a disease believe a there space of

tuned different to on is that, continuing stay evaluate team So our assets.

Christopher Marai

very much. you Thank on Great. Congrats quarter. the

Eric Dube

you. Thank


next line with question Blair. the comes Tim Your William Lugo of from

now is line open. Your

Tim Lugo

to a your think then being maybe difficult those around wondering situation? think patients in the hopefully just COVID. I diagnosed in I about nursing I'm and in PROTECT. DUPLEX through for down managing can't questions for protocol are congratulations with also I urine were and more maybe blood in sample if you just slowing patient understand Noah, patients screened, a Thanks visits employ and taking managed, defined if comments, protocols situation. that their And you general home all had guess question the able difficulty we within a enrolled a collecting how you're patients mentioned some or windows, managing pandemic. for during the how And the come

Noah Rosenberg

Great Yes. question.

think great I it’s question. a

endpoint referencing the point us. patient track that's And That's collection and XX down got urine I have we've great key each you're specimens, regard with key urine a of to on pivotal, focus visits. say So Because the And trackers of collection. the deal that each visit. the week end we a for right? think to

closely So, where lot. be still they are either data in will being we collections meet occurring. often. are continue will off clinical in collected that with even those some site in to the that it's like ensuring still sites the mean, are a that at the I sites, things parking collect sometimes there sites. exactly samples centrally they'll where working get that where you There that and dropped sites patients are being know collected, that's many tell those I

that that point visiting are And room frankly a for potentially again across set is pleased study. at I can have, There in we we an the with again some overall nursing. aggregated the data looking conduct say

mentioned had you that. think I

option a the seen that point, that additional work to haven't at sites this contracting are and huge we it support. in need are us, We case do for but of a for process at is the require do in that group and looking prolonged this

it's Hopefully question. your think question? answers a I that great So,

Tim Lugo

like sounds no, like definitely. in innovative approach. been you've the sounds Yes, It

focused people of As if easing, still many fact, do restate I domestically be percentage? kind on a June, and talk how just you rough expect to more the about maybe sites easing guess we to impacted, fast forward

Noah Rosenberg

the will this because team in I driving I sites PIs, of no got every when, us study. typically say now. engagement, the XXX. Yes, activities, Tim and this doing study, to question site. we're that That's this, tough to a We've number with drove Site to the had sites you prior engaged The see with as great conversations value. a is, what But with is that it from I've that's and the understand is a we can interested can talked to they is process. the the momentum, dropped they're what and them maintaining, have right pre-screening excited. are are recall continuing answer, dynamic very And engaged and the it imagine, if start some you

ready. not they're when start they'll screening opening wrapping we of of tie and randomization, And clinics. Some can the it up to seeing off the

as up. the see quite making are paying engaged up, open recruitment more that advantage to think and once screening they're to talking As I promising, number more and of this take can without to excited, there you'll sure things close clinic as all sites, they're and over start starts capacity. to ramp and we because we of these attention But

Tim Lugo

given up investigators I and on of know, that, you it its only want don't right you've from be if Okay. maybe And guess, FSGS and the suppressive running. to X can Phase give I'd anecdote therapies views indication the some immunosuppressants you Is heard as immune their are the now. mentioned, me I and seems pandemic, you on

Eric Dube

I'll from around of risk conversations space, and it the within and beyond, there's a that I'll take advocacy of some I've one, patient actually but very leaders had heightened consistent Yes, the the renal the rare take with that immunosuppression awareness infection.

that more this way disease awareness a something pandemic. communities And so any rare have so heightened it's even and are, during the I in think this is

And really at their state. and a many face or treatment so of is that that immunocompromized me of put going this clinical I to regardless given there patients trial risk potential is think question of treatment greater these

I think And you want add? this. of be that's lot to anything thinking the are I driving the suspect going a to quickly way. same clinicians Noah, that

Noah Rosenberg

as PIs Yes, you are, well. what we've I that think institutional or support the level just from to said heard

what likely to the saying studies So studies is up be well. anecdotally get the are back volume site that the not the sites running as of level and putting at of on they're risk of to are first patients

Tim Lugo

for question. to you. Thank the Great Thanks hear.

Eric Dube

Thank you, Tim.


with line next Liisa Your Securities. question Bayko of comes from JMP the

Your now line is open.

John Walden

and on questions Liisa. John the Hi, Walden congrats progress. Thanks this is on for taking for the

what update new you difference over this might and how evolved PROTECT endpoint, were Just or we of is previously have one on and this the the study. what meaningful kind time Could between confirmatory discuss just expecting? this changed

Eric Dube

going John. that Yes. I'm question. have take Bill Thank you, to

Bill Rote

Certainly, relatively The the post John. thanks measurement. change cessation We're for question, is straightforward. of the removing essentially really therapy

as registry really for for data IgA designed full and other study, to study window pre we've is because of data on than to gained change a We the us was with we well and the So and for based that this potential and it's precedent originally sparsentan, weeks the measurement from knowledge from shorter a was asked measurement trial what our look therapies, that FSGS specific at there PROTECT approval. patients before, right with observation four analysis DUET started had IgA listed robust as since because wasn't level robust de-risks believe trials. our at nephropathy, FDA with post the time nephropathy and access we the

while allowed measuring agency from the the to using protocol. to That's and weeks the with understand change us effect really optimal outcomes. zero therapy to made share to that modeling demonstrate this the eGFR XXX on sparsentan subsequently on is way We

wasn't the this this point out have done in We're for study, don't level that protect still analysis, patients was trial point yet. this we to blinded to data. modeling and with important out it based from done me study the as on As

John Walden

expect of you will single-digit new on then great. a ongoing, for pandemic guidance sales perhaps the difficult of commercial obviously patient little the year? be you mentioned Okay, with starts about the that feeling kind just for net product mid are how your growth you but And previous portfolio, more

Eric Dube

quarter severity about cautious. mentioned, very the we're said, duration starts at the very we the also John, have even growth we'll so to of new thinking from as to we the is through see year say But patient a and point, some that were of would prescriptions. report mid I forward this very Yes, potential in That careful of April and, strong as without our believe of we achieve continue change anything, and the so any And seen possible that. would the we to pandemic be growth single-digit it of and some some in and we pull strongly the Peter we're, rest that of new strong. for need off patient year, monitor started that

John Walden

Great. again. Thanks

Eric Dube

you, John. Thank


the from comes with question Wang line of Barclays. Gena next Your

is now line open. Your

Unidentified Analyst

on this is I split great the original patients because team, the formulation questions quarter. between us have patients on EC. switching to the Gena not. you for congratulations THIOLA EC one and David ease Do and understand convenience my sort think, still of commercial for on can see the COVID-XX, franchise affirmation I you. when question of the Thank the And help then because like a just of you partly then what's information. THIOLA what

Eric Dube

to you questions? very Peter, those want Thank do much, David. take you

Peter Heerma

question. that that Yes, Dave. for Thanks I think maybe I take

rapidly in earnings two-thirds reported quarterly patients COVID, increase EC, the we much an think which don't in with think that the of to provide we due I If was started since using continue last line of that done don't see increased we the effect. see very I more number. And research had THIOLA the that So, that about specifics. we is then We previously. to

Unidentified Analyst

That’s Thank you. helpful. very

Eric Dube

Thank you.


line Your next the comes with BMO from Markets. question Do Capital Kim of

is now line Your open.

Unidentified Analyst

Congrats on THIOLA. is regarding question I evening DO. quick quarter. Good had for EK everyone. This just a on the

bit the Q-over-Q the patients a new of there? starts of DTN and is sales terms little seasonality offsetting that on due In to primarily going in the decrease

Eric Dube

want you to do Peter, that? take Yes,

Peter Heerma

restart patients have treatments THIOLA you and moves IR the Yes, EC, actually the continuum used new that across THIOLA patients all diagnosed I we that he to that get therapy they it's that a which absolutely. a lines. towards with are using see being Yes, still and see that continue currently that EC. formulation We to also get think are EC. patients three And

lines So across EC. see three all we are using that patients

Eric Dube

in shifts we one that the the think see in I first with that do things as net would THIOLA you higher the but the other there that a usually think one for be a to of reset that volume versus there, would see quarter, that previous consistent quarter I years to potentially year. with largely add gross THIOLA I of net EC just what of the is overall would QX. first But quarter quarter, imagine we insurance is gross is differential to pattern the patient's as a in

to market largely Peter have quarter. prior in gross dynamics think as the of terms this the mentioned, net unique of dynamic then QX I So, within but you versus also

Unidentified Analyst

Okay. Thanks for the clarification.

Eric Dube

Thanks, EK.

questions no Chris further this And would the time to showing at I Cline. conference time. like not back to turn

Chris Cline

I today. all for Bella. you, This safe you well. and remain joining hope Thank Thank you call. our concludes us everybody Great.


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

disconnect. may You all