TVTX - Earnings call 3 2023 | Travere Therapeutics, Inc.

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Operator

Good day, and welcome to the Travere Therapeutics Third Quarter 2023 Financial Results and Corporate Update Conference Call. Today's conference call is being recorded. At this time, I'd like to turn the conference over to the Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi.

Naomi Eichenbaum

Thank you. to update third call. welcome results XXXX and corporate and afternoon, Travere quarter Therapeutics financial Good Thank all you for joining. Today's our call Chief by Executive Officer, will Dr. be led Eric Dube. prepared Eric by in be the will Dr. joined remarks and Chief Medical Officer; Heerma, Commercial Chief Jula Inrig, Chris Officer; our our Cline, our Peter Chief Officer; Dr. Financial are Research regarding Vice statements the historical like join to harbor not everyone Development, that us matters begin, for statements Bill Rote, safe Reform and we would Senior the during Private Act I call this made that President of forward-looking the are will Q&A session.Before Litigation facts XXXX. Securities remind of within of provisions

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

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

Eric Dube

Naomi, you, everyone. good and Thank afternoon,

our play Study our foundational believe priorities our disease our priorities. initiation the from further position portfolio, and IgAN to meeting with we us that PROTECT pegtibatinase focus corporate of of key and FILSPARI strengthen on Phase position we to study made During important to during Notably, will by two-year the enabling community. for and rare III end the bile key for successful IgAN the the completed in of the acid of in we data completed divestiture us FILSPARI leadership executed a program, the landscape.Additionally, quarter, further quarter, track the an on third putting launch reported year-end, progress our we II Phase treatment we pegtibatinase role product

we year-end sparsentan reach strategy become initial we positive launch adjustments the we Regarding provide have additional to the in built spoke proteinuria reductions through we of this publication shortly. a regarding results with Overall, Consistent patients groundwork demand kidney payer we preservation In groundbreaking compiling October, Application track that foundation should and FILSPARI growth is coverage. deep FILSPARI, every opinion in our from enhancements half and Medicine, quarter, week, engagements, on more the the impact the or CHMP. Peter helped in leaders And treatment and will of well hear together new solid And a the and FILSPARI the in submit Congress the our disease. third from supplemental who our first patient with enable have details sNDA physician continue presentations patients. IgAN. sparsentan stories guidelines of is position positively with to authorization FILSPARI ongoing even identified for published on In these patient execute new to team and an we continued England working foundational become about physicians full form and of for of recognize after parallel, into for previous role how patient education In Notably, therapy adjusted. Vifor, the for we we these are for further partner them.Over were compared quickly opinion seeing is approval IgAN has valuation the support onboarding FSGS we sparsentan in Journal we patients conditional quarter, to patients with progressing.Together of course inclusion positive New at can in and that the U.S. trends the start launch, for and been the this conjunction U.S. of early performance the specifically remain from improve in additional forms a new updates the our submitted, start potential the of to and a the a our journals. of regulatory World-renowned and Study New IgAN in are the in with and guidance FSGS so the review was IgAN on quarter. late-breaker signs and active and quarter, and for to function our It for IgAN durable lay IgAN in CSL for to nephrology future XXXX congress largest marketing scientific the from exciting have with truly year. successful to ASN just III Phase peer-reviewed to comparator Kidney from KDIGO both in as confidence FSGS.This in around simultaneously the returning humbling the the should presented Drug Europe, of and for and Lancet PROTECT Week, both new a of IgAN up and FILSPARI oral Lancet providing Key provide studies launch.We anticipate for foundational we're and

FDA expected Phase October, HCU. exciting panel development In initiation study a year-end. on our program, drug for pegtibatinase we III Regarding track are hosted patient-focused classical by on late an

looking for need and diet incredibly improve for on the was about term. only the become the we urgency to stories for our improved and to caregivers therapy, sharing Phase of and sense pegtibatinase grow, execute disease-modifying and near in HCU feel additional ability their better their grateful for We to clear updates program.Our confidence forward program in HCU, and sharing HCU. testing III are for with with the to the we're continue the potential the therapy classical living people living to first patients The

our with me advancing now our into the priorities quarter, we of Mirum and sheet a the on to key Phase further Lastly, Jula Jula? achieving bile balance the call portfolio III.Let focus to success transaction turn Pharmaceuticals. the sale our pegtibatinase acid update. during completed over This for of strengthens and clinical FILSPARI

Jula Inrig

everyone. Thank you, Eric, and good afternoon,

to disease presentations DUPLEX internal team ASN impactful Week, world-renowned This rapid with published Kidney recognize collaborators. nephrologists IgAN treatment failure. effects provides data foundational significant educate of an I'd significantly the These approved by FILSPARI significant treatment Week our like and the effective IgA at FSGS. with Before a long-term and disease delay period including slowing sparsentan such globally IgAN studies Their the FILSPARI a medical efforts rare inclusion help peer-reviewed in advance. ASN walking practice the an of the publication kidney strong potential that up-to-date III achieving us broad side PROTECT these Based and demonstrate significant Rovin, in preserve thank our without the required therapies data late-breaking data results in represents both to FILSPARI the that met Kidney Phase and by thereby data a through two Lancet, IgA in time. of us of Phase and kidney external data very and and to as as XX in presented presentations and for expert publication and abstract, on the Study led with recent of dissemination late-breaker kidney has high-impact time mKDIGO.We confidence clinical a and of are provide will significant nephropathy. increasing published effect limited recognized for the function guidelines, nephrology shared on were III to clinical with profile community demonstrated ASN Dr. the and patients, in progression space nephropathy.Simultaneously expeditiously in data simultaneous our empowered position oral PROTECT FILSPARI's support with short prospective this

patients select mls per two an absolute FILSPARI chronic to Phase year with eGFR that compared minus mls years minute presentation slower and the highlight conjunction when and irbesartan.This, or a publication. from me Treatment minus higher total patients IgAN eGFR data historical recent rate X.X X.X with function can versus per III Let kidney us in and X.X with trials. FILSPARI with minute provided at declines, treatment slope, particularly meaningfully tells respectively, with provide of per

Additionally, of higher compared EGFR, role across durable were was to irbesartan.FILSPARI of disease. with baseline of complete reduction a endpoint, irbesartan. XX% the trials failure FILSPARI the and failure compared on and resulted supporting clinical composite FILSPARI all the of rates remission was FILSPARI foundational lower death rates or The consistent reduction to sparsentan as in and demonstrated to eGFR irbesartan eGFR a kidney proteinuria consistent slope kidney and decline in these comparable potential conducted two-year in a for study. kidney safety profile Treatment treatment stages different with treatment effects significant proteinuria over in to-date the across proteinuria, across

no no with concerns and drug-induced Importantly, fluid safety to injury related overload. liver

indicate sparsentan results treatment, proteinuria growing profile data Study, are understanding medications stable that from FILSPARI has therapy initial new that with kidney in alone patients confidence proteinuria FILSPARI profile reduction Initial apart safety standard an further potential newly In and and ongoing IgAN. to and when body the the sparsentan.These of reduction important to function consistent SPARTAN data IgAN include of evidence at the in been well this preserve strengthen presented care XX other to-date We or sparsentan combination showed PROTECT in FILSPARI open-label of inhibitors with in also RAS-naive tolerated, is and help with diagnosed with over the the in early we've in benefit believe a no over added IgAN, with change clinical with was kidney XX% we combination time evaluating build benefit.These has incremental minimal SGLTX in seen extension, with sets suggesting accruing treatment function. approximately to ASN treatment patients. weeks the which well-tolerated

published and complete we was to benefits fewer show label compared reducing the of patients nephropathy, broader the Dr. failure an [ remission, proteinuria, a that for full The broader on FILSPARI.Also sparsentan-treated in to population including the Medicine. disease presented kidney next Rove and Phase study ], to positive results rare believe as in eGFR, session of potentially traditional leading trends in expansion on durable from irbesartan. steps of consistent effect long-term data support approval, sNDA including results ASN, England with kidney rates simultaneously DUPLEX oral late-breaker a at sparsentan New Looking composite should expert, these Journal of the endpoint, reflect III greater IgA also PROTECT kidney a reaching a

statistical While clinically and the on on results meaningful a FSGS announced the DUPLEX Study and a our the for in and regulatory quarter. for pegtibatinase to clinical we FDA-approved growing consistent provide or the remain a well-tolerated on treatment showed regulatory our the continue Shifting profile.With incident, indicated classical to data no high. We meet this HCU, and totality objectives. incredibly build on endpoint, update medicines FSGS eGFR advancements unmet of significance an track homocystinuria, to need previously didn't of safety on is made discussions our

threshold a As Study SSIEM, Phase and International data patients. protein, diet. the otherwise COMPOSE One Metabolic effect achieved that are that less presented on of normalization meaningful of than highly significantly reduction patient provides can or Conference, patients quality for in showed homocysteine to that total of enhance we consistent low-protein total who XX.X% treatment was increased pegtibatinase which the for across dietary clinically homocysteine XX%.This life allowed the leading additional from restrictive I/II

point, initiation study key we Peter are have III call sharing We opportunity with Phase Phase by the and of completed the eagerly elements.With recently global year-end. turn pivotal FDA Difficulty]. a will that, with the that final I'll also who end HCU design to leaders At underway meeting our teams the initiation. successful anticipating for study to the look a to over of II preparations thought [Technical study Additionally, are anticipation forward engage in

Peter Heerma

good everyone. Jula, Thank and you, afternoon,

of how new we patients third risk nephrologists We start help for promising uses new for proteinuria. we clinical are practices. the typically patient's start have growth continue speaks summer physicians to additional in profile on within launches form the reduce and it dynamic their following observed patients initiation the increase. the observed sound engaged increasingly fewer the to had season clinical face-to-face in of Since slower of the to prescribers to occurred nephropathy forms.This make over commercial even of in in in launch continues and confidence the ambition with FILSPARI progression. patient new X,XXX their establishing benchmark these interactions February, of beginning a becoming we common resulted IgA foundational is while the demand when And of Notably, the Physician with summer Asian profile These at quarter, in nephrologists achieve patients rapid see nearly months. launch. notable fundamentals to and represents our growth the a start they progress making X,XXX using and have FILSPARI have This XXX the as it therapy forms FILSPARI. since

that after Jula, our market market As X-year research the results [indiscernible] from faster release than line analysis from number the you that have market nephrologists a prescribe the furthering rapid to confidence and that the the shows not reviewing by gives months And confidence of recent have This X-year eGFR that heard Study three long-term benefit science to consistent and indicate described feedback and the with sustained provide PROTECT nephrologists demand based into through XX the this of received PROTECT research.In after disease FILSPARI of we surveyed medical conducted year fact, X-year the see of also recent XXXX. new indicate FILSPARI on significant increase do for data of top intent have meaningful to is safety reduction results that feedback X-year press on us plan the continue could balance expect kidney experience yet their to growing delay their also in and currently indicates utilization. XX% that the prescriber data, a profile the progressing.The the encouraged research that in prescribe. physicians, data. the will proteinuria Nephrologists mentioned are they and function next

FILSPARI During QX. also progress the covered engagement in continued end U.S. by of lives the of with the quarter, our we for payer XX%

of from criteria.From revenue to very end authorization and the the with of formularies we XX end quarter. the be FILSPARI the of And XX perspective, reported more these $X to million Importantly, by doubled FILSPARI-specific of than quarter the for second our QX. third we we by a net specific quality nearly formularies sales continue pleased

this closely the demand without or shipments. of that who, and receive see revenue, from to either longer support not inflection seen education increased REMS, it matching start taken therapy yet main of first initiated is is beginning but yet forms. the are The intersegment upward patient We in their expected to not component the on patients have have

this this data adjusted patient that the recognize important paid communication month for early in for the approval increasing.As for support, working. call fulfillment Importantly, be and XX process the our signs these are support segment February, segment over their our X-year the launch in been discussed targeted rolling including patients to we FILSPARI's a to Both on patients, during enhance would the and punctuated that enforce by teams such need quarter.We as receiving education quickly of start patient months approaches reviewed additional first and seeing and of are additional materials enacted and communication efforts Notably, toward form after number materials patients publications. their We we with educators conversation X payer patient certification therapy FILSPARI. certification the patient shortly educational online. of support candidates provided additional An a for providing the and initiating that patients REMS through completing on support [indiscernible] guidance for we patients have milestones, precision REMS patient-friendly patients in print process. are increase

ahead, body the in importantly, we see have ] at U.S.To the opportunity sparsentan growing key launch upon be confidence the planned most FILSPARI Looking in the to in full prescribing of and great of with year growth future in [ [indiscernible] FILSPARI in fundamentals. close, submission of for IgAN SGLTX. of the updated with The sNDA based approval an we trajectory further next potential combination inclusion evidence

is the patients from treatment FILSPARI's prescribers. [indiscernible] the nephrologists, needs superior the progression; shown profile, irbesartan by excited addresses to growth. and of of profile and FILSPARI high and demand forms has increasing which rapid with have IgAN are to patient the we First, two, risk the demonstrated compared increasing new profile. compared a start and about progress.Quarter-over-quarter, repeat FILSPARI Three, coverage payer payer active

FILSPARI. of approvals payer Now lives are high And level the experience two-third patient and we're and four, adherence. for seeing of covered,

We persistence the and we compliance on proteinuria continue FILSPARI, seeing therapy results levels. patients high. are in both is patient once clinical have to their that feedback starts that positive And hear

is becoming the adjust to will patients team ongoing our strong quarter over based on achieve at and ambition we rapid on a me risk progression.Let foundational treatment the Chris of learnings call on Importantly, to focused to now IgAN for financial FILSPARI continue delivering our the fourth Chris? for turn update.

Chris Cline

Thank you, afternoon, everyone. and good Peter,

our continue Following financial for our perspective, operational revenue, in we're focused we third and an to From future. we quarter results, strong a very the position. investments grow

We also meaningfully financials, is discontinued the be result, which being sheet. continuing from our and following balance as otherwise as our the noted. years a our value has the on several and operations, completed brought portfolio bile unless operations reflected In will focused forward product of the strengthened acid transaction transaction, discussion

XXXX, quarter of XXXX.The net EC million IgA net and sales quarter. attributable increase contributed million well product ongoing compared third also third sales continues be of an $XX.X launch nephropathy. FILSPARI the $XX.X demand. to to Thiola to $XX.X the sales from perform in continued same by For were in growth in to driven This Thiola to for net in the million the product organic increase is primarily product patient in and period

to million of Total XXXX XXXX. income in as quarter million for non-GAAP for for were the $XX.X third share the per period compared the the same basis, other compared as legal third of net as compared as basis, for of $X.X million pegtibatinase million during XXXX for was expense Phase for and of $X.XX difference quarter non-GAAP for of $XX.X general adjusted net same $XXX.X to III basis, for program well million adjusted in period approval to to the the XXXX largely company's same other in in third non-GAAP of attributable commercial a XXXX.The same expenses third third quarter compared for XXXX.On increased $XX.X income, $X.XX revenue, an or of February $XX.X third for a development including total fees.On including to in XXXX of period million $XX.X or collaboration to XXXX. million adjusted basic expenses $XX.X a quarter, basic loss same share net On SG&A launch-related per which $XX.X administrative accelerated quarter in XXXX from to was the XXXX. XXXX was to the the expenses FILSPARI The increase Selling, expenses for recognized operations also the the $XX.X The and R&D XXXX. the including quarter million net were largely million million $X.X in is expenses attributable total income million share is period difference for basic the $XX.X period. a license initiation, the clinical Net in XXXX. were same the and discontinued XXXX. income, trial translates share During $XX.X of period quarter loss to compared largely the million million a discontinued the same prepares or we $XX.X million interest the quarter revenue advancement million in clinical attributable the it for third of were of from as to the net for in to Research well basic period of period headcount. the to compared $X.X and following difference in $X.XX per compared $X.XX activities period million or $XXX.X period million XXXX for compared in per same $XX.X for manufacturing XXXX continued of is operations

company of cash bile strong cash ongoing expected investments pegtibatinase ensuring advancing XX, a position, year the closing of XXXX, that the launch conjunction securities in million reduce includes development. maintain our portfolio allocation base marketable quarter appropriate in This are received into FILSPARI the of had and the approach this following proceeds $XXX.X As from the million. we're our and during to divestiture.To disciplined approximately capital with acid III Phase is made cost while $XXX of cash, September the gross equivalents

his the these and reported third sheet can Eric with efforts turn we to to end balance beyond our support our comments. at manage now over cash of XXXX.I'll Eric? for quarter, we believe Importantly, closing operations the it balance back

Eric Dube

making on Overall, Chris. treatments remain accomplished The our of incredibly patients Travere third you, milestones, the Thank for innovative for towards team proud and number remarkable has execution. delivering team's I significant diseases. a quarter, executed with progress of rare

we to enabling community a both III is scientific to deeply to FILSPARI of our at our delivered as remain FDA quarter successfully IgAN and ASN to traditional with on Feedback PROTECT track in confer update data Phase the ultimately pursue for on continue this demonstrating have for in hand, quarter. from We launch IgAN. become demand therapy FILSPARI foundational our the sNDA and our remain approval.We the FILSPARI encouraging FSGS confident in we engagement an continue FILSPARI an and plans for goal provide

packages disease-modifying from its data pegtibatinase the transformative the become a the Additionally, support Phase to community. Study I/II continues for COMPOSE HCU therapy potential to for

and We we in this study program our are efforts to initiate track a year-end. pivotal excited on continue remain by to

As the concentrated we of strongly. on the are end efforts our finishing year, approach

living We the remain lives of with pass on individuals and Q&A launch, the with continued committed the Naomi? rare advancing are of focused on questions. profound pegtibatinase the for to now Naomi our call promise disease.I'll forward delivering progress in differences to making FILSPARI executing over

Naomi Eichenbaum

now Eric. you, Thank up for Operator? line open Q&A. can the We

Operator

take Instructions] will question Joseph Leerink we first the [Operator And from now Partners. Schwartz with

Analyst

] Will [ Joe. on is for This

be comfortable this. there if fully nephrologists PROTECT profile of are quick among appreciate have readout? follow-up for then syndications And a there the more the the patterns totality after to with the group any I notable those are as any seem have So us, interacted data compared you to to start yet? who may wondering that with that to the not Just

Eric Dube

excited what from you Jula the turn view can I you question. very meeting reactions. thoughts the about are I don't What a for that thanks walked away Jula, why her the in Will, early heard? share with that will ASN consistent nephrologists for profile. to over say I is the that

Jula Inrig

I Eric said. with just what would Yeah. agree

and see additional that data Trial that function reduction sparsentan say to and the time before like to future, promising potential regard it's results excited were earlier that I people and other -- that some would was and you [Technical feel additional people see reduction failure. even -- the the that thing ARV, SPARTAN think safe has people the effective. rapid would Difficulty] demonstrated inhibitors to data, delay shows the and that say the is data And even the were And showed use it potential early, full looking very well, they data if preservation combination important the IgA durable more of the the significantly kidney be shows has of with and or we data treatment I proteinuria presentation with ACE they've and you of when you early it's proteinuria in to with in from foundational preserve thing is nephropathy.And to in treatment patients function. that and kidney to the sustained as get treat the if seen see to and I totality in kidney

saw demonstrate I and consistent show. were what able a So response believe we to fairly we to

Analyst

quick here. Great. follow-up And then a just

published saw a eGFR, different literature ml relationship you any should suggests a outcome. what PROTECT. Have have you we the for in results, to XX% reduction of but you do had per the have lead and docs benefit to better idea the have now have the mg a some on around Given from that may bit that concerns time drove in proteinuria more X.X review heard data this this? And on

Eric Dube

Jula, that I'll one pass you. over to

Jula Inrig

combination, action, some where model that we with a decreased. data a over some consideration.Obviously, of study and is look the the X.X saw When analysis know annual greater years, we years, an take acutely take all treatment and term. X is that stabilizes eGFR Yeah. we away of meta the favorable Happy after to slope acute absolute data see effect year. where function that. answer really over of slight mechanisms that X and drugs long drugs ml a benefit looking at that's X point benefit for you're And to the have benefit important mls is And an that, difference kidney that -- sparsentan, at that and and per effect, different you per increase over X-year accrues to the time. minute thing important than with into This

get it's year, each X.X you you next and over get. the years, than year. other X.X term, X.X is different benefit [Technical That's message take-home eGFR which X It drugs, at long a So which Difficulty]. accrues in increase might the very important that the the

Operator

will our come Rama with And next question from Morgan. Anupam J.P.

Anupam Rama

kind year. On the patient the beyond growth eGFR? like Maybe about there of X-year group physicians start of the opening any a on color little sidelines to headwind sell on PROTECT that. talked us little Was a bit what the us a seeing bit more forms, maybe the month-over-month or you seasonality give can on on particular give the marks you're you in there color that that quarter were summer beyond was more the

Eric Dube

seeing about have he terms much is the so for talk in will of prescribing. question. Thanks I Yeah. what Peter

Peter Heerma

both say, patients I a continuation prepared show had headwind, as But other But any of little pleased majority Yes. are we Anupam. inflection we're the see demand. And I as overall, from as today prescriptions a growth being prescribers. through July seeing really good that's of what new quarter. see with didn't about from on growth the other these And a well. I'm Thanks, and that we of and the I we the well than coming talking most physicians, repeat would commented continued was the remarks. the see prescribers their growth see community managed seasonality we of why from continued in patients as when continuation perspective, we overall, during less physician

Operator

Raycroft our come Jefferies. next And with from question Maury will

Maurice Raycroft

a I just ability the Since how think to over this washout for open-label alluded X-year data accrues Jula PROTECT FDA to patients extension, I account starting longer-term show can the you this? the in accruing the does that time a and effect for guess prior benefit treatment there period sparsentan washout. to is PROTECT impact Study. on beyond asked in case way like

Eric Dube

the pass over that you. Jula, one for thanks Maury, to I question. will

Jula Inrig

it's because question the in treat a not going long Maury, Yeah, term. fair over how reality, that's pace to we're

where that because standard in keep And overall to hemodynamic in them patients after is durable went favorable treatment of a a you eGFR say be asked saw of what acute question thing to effect would was I but the patients care, we would absolute effects. wanted back that that sparsentan You washout. the saw was important on, an

Now comes monitor important those the the resume over continue they open were think to trajectory of who out we is data patients those versus what we'll that to have I that for switch is sparsentan. irbesartan on label can when sparsentan.And patients

So believe incrementally over have that your from long it time. But point, the this provide supportive sNDA we'll we filing important we to that will data be the our term. at will in double-blind information be the of that point

Operator

And our Bank Harrison America. come of Greg next question will with from

Greg Harrison

of in appetite volume are patient start the you And any before the you from data? PROTECT after in and prescribing hearing to forms Are physicians for the on give the periods their able of of light on the FILSPARI data? announcement feedback color what

Eric Dube

to bit really early sort academic. questions. would that. the some in ASN, for his including at where can qualitatively research data coming a look some say I Greg. quickly of much too provide greater before that excitement, PROTECT actual hearing those what What of on to projections more team it much able before particularly was team was Peter be over quickly there out great after attended more did. to prescribing. say research for to that I handing perspective real ASN the Peter's or understand to did a really Thanks market of exposure to It's terms he's

So a bit Peter, you learned? more don't why your share little about what team

Peter Heerma

patients little think a Yes. the the months. start question. quarter, that XXX Thanks patients for the I X.X say, first a the would of a all, forms like first is I of number X,XXX good [indiscernible] really third in

that research I ].But see point, this good patients. saw the think think I research, making there [indiscernible] FILSPARI the press was many had profile physicians, we FILSPARI after a conversations profile, any Eric's the overall, closed of progress what totality the release in the it's announcement To physicians' the too [ of change data in those top reception confidence having early of in is really we're market a there think FILSPARI of deflection line was what with data for of there. and mean top is good right the having the really can good I line and to the and market after the

more overall, good think I and So go. reception yeah, to

Operator

from Vamil come our question with Guggenheim And Davin will Securities. next

Vamil Divan

things now the way side safety many the curious full side you any their then I how of of of are share both you the certified of as well just other we've theme believe, DUPLEX? prescribe feedback as safety you questions, on terms was about of on REMS I'm you've program can kind more just work the shared, on [indiscernible] share through things? touched in some nephrologists, of can that number sort X,XXX now data, feedback nephrologists if and again, PROTECT And now are REMS the said to I anything think seen it? you some the of

Eric Dube

Vamil, thanks for the questions.

Before profile. provide we share to can I'll that well on directional over is REMS what Peter, feedback just some as as the the I hand and qualitative it safety

but further to little perspective? the you that. want don't hearing, add ASN certainly, why on of and you Peter? We reactions are continue the means Peter, all add to about anything from see bit to on and that metrics coming reaction there's providing we patient And talk if what directionally out safety the you're both physician not Jula, grow. by what REMS a certification,

Peter Heerma

just about nephrologists in I of as our indeed, we XX% that the are launch But interactions. we X,XXX And amount of face-to-face have is want have seen very interactions out the were that about Eric. to nephrologists good we certainly progress that bring the call seen referring I we force patient on nephrologists population. I think announced with is, And call face-to-face Yeah, a think, during in [indiscernible]. that we field consistently because call, to X,XXX

making your the think was for I question second progress. that you of been question, profile, an days nephrology more the part Jula, the safety appropriate And regards so I good With we've we overall perspective. early answer. think And to at maybe really from that's are to

Jula Inrig

Yeah.

sparsentan program the no I think PROTECT to that really across the exact regards elevation safety both around DUPLEX, same I interim of with limit PROTECT. new with would since our profile the saw the to-date, profile upper respond significant normal and regards where Xx reassurance to safety we liver from and elevations of

which, to data this to. will of but we physicians go move can -- where move changed as over time, rapidly physicians quickly continue this back, and is readdress course, to accrue where be that's so And

reassured of feel this at safety profile time. we So that

Eric Dube

have behind box his to fact, pharmacy to maybe with what that other add going information, up And ARM and ] in Vamil, be reaction ] the Peter many prescription patients one might are to is an and prepared REMS. others. is or a them really other [ just shared or of helpful a on insight Most how familiarity nephrologists think REMS.For some to familiar and that's accustomed for local physicians picking of physicians in can the it's comments and their hand, comments. the [ represcribing accustomed patients be I morning really what ACE a some of the to -- may an just that And versus REMS. are I

education it talked handholding bit for So more a about, requires of for support. Peter more does patients require process it some segment patients, bit a that the bit information, through a and education, that more really

referred doesn't physicians the REMS the as time. we're And is so where take what little hearing that REMS more there overall, very we straightforward. is to, time.But It's much does from a take segment, bit a

we do able their many think that the they to works well, need I to sure to we're For all make need be prescription. information it providing to patients, from patients forms fulfilling actually that incredibly start but patient move

I as process we to that all possible. the to sure quickly the insight through quarter move and pivot make the think as key had we're patients able that that was So this

Operator

question will next our And come from Liisa Bayko ISI. Evercore with

Liisa Bayko

give just the example, did by end to at like a on many you're the quarter? have And things there? net, detail you of patients us actually, on therapy Can you for then how gross little where

Eric Dube

And to patients quite why say for? Because a we of comment don't on that to Chris, on through is in other as a position first that Liisa, launch, I'll number yet KPIs gross variable. of or it we to be of therapy types are go year imagine, able you the net? you not be have looking can might you

through as their just the process. as patients drug that You've are reimbursement well working on got way free

we're point. we be not this position in able continue a comment very So can say see to to in demand. But I that at to is strong

you forms. inflection continue that to to continue more the and start We expect demand revenue closely in do underlying to to net? comment gross on of aligned with we that become Chris, see patient want

Chris Cline

Sure.

expect consistent with mid- feel consistent what sparsentan high So to place. high variability of processes and or now. getting Liisa, with that's to end we're There's the gross as operating to teens, teen to with we But of how consistent be FILSPARI in to prior as that's we're be and going elements etcetera, in and range very different that today. that our to all we're the overall, reimbursement, see we stable state a net up highlighted, guidance, we mid- Eric quarter-to-quarter some confident going

Liisa Bayko

how patients of And quarter, many on you have the did at end great. the roughly? Okay,

Eric Dube

is during of on report launch, again, did variable. We therapy the because, first part not on numbers it of patients

would to to able able getting allow basis so forward. to And to a a to be project consistent be us report on steady state

continue many So you at guided metrics on start coverage and revenue. on since going report three -- to patient to payer forms, And those and on think I and the more that in that to February, to only that we're to point, fourth we this expect shared continue as see that and medicine, are had QX from the QX reimbursed beyond. from would we patients we revenue through quarter inflection that we have

Liisa Bayko

Okay. out And update -- KDIGO or at coming the on any then commentary guidelines on guidelines? new

Eric Dube

Jula, do guidelines? on you the want to latest take the

Jula Inrig

guidelines. the Yeah. and our was then to peer PROTECT we going We're KDIGO And and Those complete data, reviewed. to the have We XXXX. were be very knew guidelines. the pleased be interim be or our available -- data in able the will that in included now in be quarter get commentary also that that first will for very included reviewed we published published of able they to results public

Liisa Bayko

one of by the that can eGFR, and to do just there relatively I we landscape how for of of eGFR? then the on or guess flat struck you're you're Kind in of about [ eGFR need the final able of remarkable evolving, kind ]. results is better of in you keep thinking kind of that context how presented [indiscernible], And see curious great. B-cell the context question Otsuka I kind see the do of as for of change having the that, other modulators things? is me. those kind and on was of still kind top April a about eGFR mechanisms for other Okay, like proteinuria that in is But all if like of just what which effect kind targeting sparsentan you really

Eric Dube

about ability excites the are that of is landscape. maybe is FILSPARI to new these And kind or the in kidney. the view that What the therapies RAS top -- have of inhibition of really the us to developed. about each of on I'll with over-activation that of talk of her combine thing classes Jula that evolving profile occurs share the all treatment Yeah. them nephrologists address the of of are in being studied I'll being

I with alone. RAS inhibition think now superiority data of versus what X-year is our the we've seen FILSPARI

and you're view peers in that you think on is this lot of therapy. in but your a by that and do from how foundational landscape? do I you it what nephrologist what you hearing this as about what want that's So patients it how when treatment to mean way data the know really we of comment positioning, is combine and early, in is Jula, and a that we question the the really emerging

Jula Inrig

Yeah.

your and to said, Eric foundational can diagnosed replace RAS to twos. if what you I think function. with it's incrementally already with When you is demonstrated damaged important, we a function need And with need in a PROTECT nephropathy, inhibitor closer kidney have the IgA as sparsentan, get preserve you reduce proteinuria you the normal to its kidney get you treatment. you ongoing,

on.With get either treatment remission the option that patient subsequently, We or add want X-year add then complete certainly, to If to data. you progress, treatment that's an data. into to XX-week data, doesn't to that's additional regards alternative on [indiscernible] if similar showed continues

of If getting you change and in into patients trial early, eGFR very reduction two-thirds proteinuria, early complete in the data. data, SPARTAN treatment remission start XX% no

data the I other therapy we're of do But function kidney follow is to need sparsentan therapies. much IIs to from increment preserve nephropathy. future and to foundational as that We the seeing as with that as can, combination IgA of believe treatment for do we we want again, out. with the So these treatment patients Phase further absolutely

Operator

will And Wells Instructions] Mohit question next our come [Operator Fargo. from with Bansal

Analyst

contributes would have more to for Adam this? persistence formularies FILSPARI is separately, seeing This how on the and prior that covering upon what you you think edits data of I terms update touch step an And Would on Mohit. ] early ops patients briefly [ have REMS you you're and FILSPARI? on you for in appreciate then

Eric Dube

working initially, story ASN about can just years patients that would about you was offered go a And a for proteinuria he really he felt a shared from with from week, our like in a were in monthly compliance think therapy, -- this to looked bit questions. his the there ongoing the Total longer-term do physician.So and be additional FILSPARI. that And many a who to services, for the a this regular can for that to at REMS their get where check-ins calls you shared center. last to having and aha more moment think -- that to that young, know patient share monitoring otherwise struggled explain I uncertainties a persistence our and for are What heard talk many audience patient to from talked he it he his a patients, what particularly we our for those with had many as patients, Care persistence really for healthy, or nephropathy, for I mean he as some little questions many patient real about down hub those services as and that additional an but as busy, want really him.And testing what turn us I'll a physician the I may imagine well was compliance actually, a I and before and those his And nurse of support support starting challenge. new about Peter, IgA Yeah. many therapy. forward with that that be was I've journey do, from that to well

was really it the challenges that think about lots I of -- is benefit. heard So We've real of a questions REMS.

he regular the anything you think Peter, to as I health. on further looking monitoring and people the payer his job as did that really in of share found value an after incredible persistence coverage? want do articulate he what well to

Peter Heerma

thanks, and question. certainly, that for Yeah, Mohit, Eric,

correctly. question was on components. and One on was One was your one approval. think understood on was REMS if persistence on three payer you compliance I I

one. go one So let me by

the questions still the we prepared and monthly more that we're the clinical that through these to Eric this in education know initially that compliance persistence on to for are results the think think with therapy. days, and I all in as well, I With we as remarks, a the and REMS remain well mentioned benchmark patients process the also coverage I the think What progress is for made rate is a on patients working progress patients very rates. products FILSPARI it's we little perception strong alluded matches closely are patient early making received I earlier of the approval overall I which of and patients of REMS, payer support. on and and segment really persistence, we patients the numbers.But so as amount regard good far compliance handholding [Technical and Difficulty]. are well.So also seeing seeing and needs pleased on see and a large that within in remain monitoring, there's one with there the have FILSPARI, really

realize patients have had for the than far June insurers we second guidance the educate only physicians approval. FDA think other was is to that it I the opportunity as to until as and accelerating you packaged of half the

translates of already the were And group shipments also additional is end patients. improving. the for So to early of to seeing are patients. support really, able REM provide additional for June, educational patients increase with FILSPARI That in the that then we by into an that support, we certification

Operator

Carter from And with Barclays. our come will question Gould next

Edwin Delfin

Carter You've Gould. Edwin the for Delfin got on line

I II impact and guys on but the have for pegtibatinase the amount impacts measures have We for any question agency a completed from biomarker end you Phase of you've the on know meeting, received follow-up HCU. primary of endpoint? the beyond clarity clinical on the

Eric Dube

Bill, why much so more take for we'll really thanks we've share I and that the to at we what sharing little and turn over more into once question, before Phase be certainly, But III of much detail we that Bill are moving Bill, Edwin, publicly program here -- soon. HCU answer questions. point. those on excited shared share don't about the this initiate our it you a trial can to bit to will very say aspects question But I design. trial the

William Rote

report of Certainly, benefit. that we've for the as to to endpoint all collaborative the completed various intended We we that now on homocysteine at program agency, the of as We've noted. clinical primary that Phase the discussions II, you I'm I'm with happy aspects very end are look had off study. the and to total you. There as along aligned

are those of measures Some of function.

quality be duration. And detail we'll we're give program. asked do starts, going of have Some you to Phase of said, also overall I the Eric around life.Some the those full Once to this. a III at looking will And of picture study more diet. with able you study those are about what we're of as think

those the the window less than X XX therapy and of And -- at of months that XXX. you studies, ranges observation look we'll to if range If we period in replacement other of are most enzyme studies months. from be

you we're where have started. has of headed, of ballpark the gives kind that studies think I more and once a we'll So

Operator

Chico comes with question Laura our And from Wedbush next Securities.

Laura Chico

forms? the I wanted I for the high with they for back guess patient first go XXX got year plateaued to over back, XXX, start believe I've If patient of the first at example, how quarters. go look can you moment for is I of launch, start at to I terms during four and form out you Tarpeyo's XXX the enrollment have peaked a question FILSPARI in

to as curious whether So think actually more XXX? you grow you can this much beyond

Eric Dube

So Laura, I think question the unequivocally, is yes.

year. measure We forms X,XXX And Peter, addressable that to really a hear as want the prescribed, important and That's for In just and we patients. quarter third emphasize over are we're we lead believe to patients positive we anecdotally that any repeat be are those not added nephrologists from I the the enthusiasm new increase. we have identify through to those the results our my will But that this be prescriptions launch. are there. really it of to number think seeing those prescribing, clinical able prescribers anticipate month. start experience, nearly have I'll that confidence patient the about but critical. that turn of and able hearing, feedback equally, we're every seeing Those experience, but

where So we and bit we Peter talk go to here. expect a about to it seeing can from expect what little he's and more grow, do

Peter Heerma

Eric, Laura, Thanks, for and that thanks, Yeah. question.

are three components how can like you To here really question, how there's you that think your answer go to would like out highlight. far there. and I basis I

in research in one limited with are what nephrology the urgency the XX at little with the be now to in What the been those The And discussed product particular, innovation been new patients to new increase based medicine. IgA adaptation in actually we on in population last like well increasing is really years. education, as part see historically, will slow I RADAR and is, a where disease. rapidly.So more more that patient and investments new and part that's that progress nephropathy lot publication that first physician a of in the physicians nephropathy, last context are would of data over has And relatively relatively I say that a in treat is registry progressive because the call, there you seeing guidance. I guidelines IgA of time is right think would provide is we little have earnings conservative the there on also new expect that can education.And much also XX providing Jula actually in the that

Eric's I'm So continued I pleased recognition really the urgently. more and To early FILSPARI. within now we patients been progress see first treated that say point, have X,XXX the that the context, there of is with X.X be And with and have nearly more all in we education a these months should I and investments patients making. community would

little example, more Jula, on So can context for your you on, provide a RADAR. perspective

Jula Inrig

Yeah.

showed get progressing RADAR to and which that of lower That information Peter's the even at dissemination their presented as always within that and lifetime.We meetings that trained go proteinuria proteinuria additional failure their can point, don't treat the into benign to to that physicians then and always medication the them kidney community journals. And IgAN they And physician to kidney preserve even and then not we think and send that that to to these were ago that U.S. ASN proteinuria with disease the translates urgency the milligrams reduces years educational treat of kidney and data, care out see as primary is with are is FILSPARI, of them kidney every to in this to function. data with And at I information, as failure. is understood XX, see registry their confirmed needs that results. increases. a case. read patients they back this at their what they them who such patients they similar don't of had realize physician progression program foundational risk are to need to XX educate ranges Patients XXX few the years historically XX, risk the data

Operator

with question next William will Blair. from our And Lugo Tim come

Analyst

[ us on for Thanks ] John much Tim. so is for squeezing in. This

and how with impact was recent you might give data data, us forward? the could the regulatory that some I think that thoughts if wondering you So might landscape moving just atrasentan on

Eric Dube

mean additional that there be data, potentially certainly to expect new are Yes. approved. that going I we therapies going to are be

I think were no there us comment it's because data hard disclosed. to for

from comment. to our atrasentan able to see have to I mean, working think an for is it us what so presented wait endothelin to that assumption And be I is we'll is blocker.

PROTECT concept So it safety We that should on before demonstrated certainly got we've to seen with can show we that we've blockers. benefit. But data with benefit comment. of endothelin sparsentan, see and with and have other proof the

Operator

will Thompson Stifel. Alex with from our And come next question

Alexander Thompson

of could impact comment low the the at you there, in in the at then past, year your be would that the of in you're sales maybe in the year, I with could think if great. this I you for $XX maybe this that guess you reiterate uptick the comfortable second range commented with also million on point. are consensus stocking confidence which And I this the guess half numbers quarter? in on revenue all Bloomberg

Eric Dube

Alex. FILSPARI and I What the launch have stocking be on to progress start it question, the the I'll the that that to in first of grow half inflection that to impact that terms to Peter proud talk we number the we'll we've in closely. then I'll go to, to we Thanks, revenue closely that with made start Yes. signs over as ability take demand incredibly can say the that more of demand the aligning turn of the we've patient guided able part with of see to to about track continue and year. think, throughout is show still And back to of room year, early some the Peter that underlying more alluded as of this forms.I of I'm expect.

seen we year of to that case that patient well. their quarter. of we've won't in quarter. We fourth meaningful when sales we're expect renal look proportion in fact, that And we've fully rare We of progress to that first expect that a the of launches, but continued at fourth And other for the going both in the provided make that be providing this the as so specifics us with We've and forms on of year. inflection far. year, in are not We seen the we inflection guidance, in terms the confident start of rest revenue. there's

Operator

comes Allison And Piper Sandler. our next Bratzel from question with

Allison Bratzel

follow-up to generate use one kind line just and broadly? and or more discussion. at what catalyze is really Just understand prior IgAN think data based a prior study this with in additional of use you of nephrologists on ASN, a the to us But just your SPARTAN KOLs, help first-line on you earlier or just question drive need you kind could clinical and update widespread to interactions of FILSPARI

Eric Dube

under you're then that in traditional perhaps do So to see take let that, market on comment Jula label much expect now hand. to you're we approval on to want expansion. Peter, within approval accelerated Jula, focus our expect We to and what we've that then I me right nephrologists? that focus over part And I'll it hearing very at and what of Peter. is additional would the But first, further is research? you hearing to got from turn What data with would say would

Jula Inrig

point, newly in ones Physicians that's as Patients for diagnosed for label. haven't about used RAS Eric's risk who primarily who first-line the SPARTAN our now, we're magnitude per treatment function progression to preservation. of excited the and reduction potential yet are kidney sparsentan of and the prevalent be inhibitors utilized and patients generating this data. proteinuria remain IgA who we're the failed Well, a being very because to one right at data nephropathy only are

patients. novel out well biopedence with profile going the as SPARTAN the that.The to that's that incrementally can in data the study these I other going data, fluid kidney this biomarker have So biopsies show repeat data to think come some important of some we're data shows that this data, is that safety of the as the the the in from

sparsentan incrementally, patients play come of further will therapy regards in IgA SPARTAN to the going confidence nephropathy. information with place So give can to of the that out that's with

Peter Heerma

Jula and would Rs not for that have have the are building that of the that research very And both over a we that half from As inhibition on market to. you'd patients thanks physician and are basically failed proteinuria getting know levels As like target RAS patients and Rs. I say Yes, on data of as to strong now we

third being now evolving are then the patients was a So I patients segment.But the combination data last we combination we RAS ASM with think very as treatment go additional also lot And upon strong have to data we and think the as of week still naive. category mentioning. have building is that that And information that Jula for patient landscape in therapies and really well. prepared context at SGLTX provides presented in I

are data from we think treatment. could that the building benefit I population So across the a in evidence FILSPARI broad patient

Operator

Wainwright Ed & And with we'll take Arce H.C. from Company. question a

Antonio Arce

to for for Peter Philadelphia. me great And me. squeezing Jula, Thanks questions see this in. it's and Three weekend in

I effect one Thompson of on. First the a the basically Aliza and chronic conference, that in sessions there early there's hemodynamic saw all, of discuss total the acknowledge slope at versus

you could for with you launch approach totality I'm the ongoing of in data of supportive data in full the just wondering discuss FILSPARI. meeting the context all your if in approval.And of and of more light so the that, FDA other just the the the then thoughts discuss two as terms And of

then can expectations. if there the eventually Firstly, wondering if PFS I'm steady-state third line now treatment can from discuss further you you X the and the also discuss lastly, from PFS time perhaps any initiation, in then October, is quarter? acceleration conversion And

Eric Dube

Okay. Thanks, Ed.

Peter, comment So in can as as And we talk October have the of are about perspective how and Bill, you on Bill? conversion. well we're you regulatory directionally data. what totality I'll thinking the about seeing

William Rote

early about but her were Thompson how to in Certainly. around want the on good put patients to increase things in kidney patients. going across had a the pre the eGFR, in show are driving I out, drugs both compounds endpoints is the overall that of on of thought both validated ascension or a at for high the session chronic that complete a there was they're they Thanks in meaningful the measure they different was best total rate kidneys, slope, surrogate. these X showing a disease, or in IgA that for those on looking years I endpoints. to that all that the remission, different to and on have that in progression, progression all get endpoints, years, And they III ways slope, failure loss with compounds it's that. there's are stages remarks, these studies to this one, of body effect question are the hard effects also And mechanistically, outcomes together a difference kidney you package at blockade consistent therapy And surrogate endpoints, discussion And safe the the over data evidence.And disease as the Ed. accumulation later looking that approval background measurements endothelin clear kidney that of the pointed the is assessing toward a whether see reduction a absolute patients questions, for of Phase itself, of the the post, and with in required benefit negative the energy function. it's Dr. very X.X now in very an think really across of we we've agency that. moving various is for very with risk have nephropathy the and of the

to I'm and the we to So have in very a make case the look strong forward that confident review. I very the agency, with fact

Eric Dube

would the which not providing of Peter, comment right. in you direction and seeing All on metrics we're on conversions, the like October directionally. we're to what

Peter Heerma

we like coming continuation in a And to patients [indiscernible] really And Yeah. start what shift. to to remarks, I mentioned see patient demand, say new I I that. prepared point, also we say of practice with the metrics see in would a we pleased the Eric, in, increase so regards comment not that quarter. within with would the your to have on to

So pleased moving inflection and have also fourth XXXX. in and the to the I'm expect quarter progress with in revenue further into really

Naomi Eichenbaum

you. call. thank XXXX providing We Thank your to financial everyone, on joining forward results quarter additional day, a progress. for Have third you, rest look us great for our of and updates our

Operator

for and conclude thank you. an that excellent. And We have conference. your do participation Thank does you today's

Travere Therapeutics (TVTX) 7 Nov 232023 Q3 Earnings call transcript