Earnings call transcript Q1 2023

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Operator

Good day and thank you for standing by. Welcome to the First Quarter 2023 Intercept Pharmaceuticals Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and answer-session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Sagherian, conference Relations. Executive like speaker to now Nareg today Director would hand over the your I of Investor go ahead. Please

Nareg Sagherian

call business updates. Good us quarter you thank financial to today's XXXX key morning first review and for results Intercept's and on joining

OCA pleased for NASH. are launch also of commercial share to We overview an our strategy in

Our XXXX press now at website our first release are Quarter intercept on and accompanying pharma.com. slides

statements strategy, I'd discussion, making we to our that we and our be development commercial matters including guidance Before will certain forward-looking statements, future clinical note like regarding financial product prospects, approved regulatory begin performance. and and program, and financial our

call, cautioned speak statements no that, be obligation and forward-looking and Listeners to except although reliance undue to statements, update of not such to inherently only on number required forward-looking to the uncertain which of and These statements by law. these estimates assumptions a believed this and are risks subject we are as as uncertainties. are undertake place of on based reasonable, date

could not that the with predicted results periodic the those our this in or but necessarily are actual filings morning's materially statements our our discussed risk forward-looking all in or anticipated to factors release press historical and by of from public results Some, differ cause our SEC.

Dr. Durso; Today's Richardson. and call Officer, Linda will our Officer, President Berrey; of our President Jerry Chief and begin from Research and our CEO, remarks Officer, Andrew with Medical Michelle prepared Chief and Commercial Development Chief our Saik; Financial

for questions. then call We will open the

but more we the are today's for call. typical, our have than Q&A note prepared time that Please on depth during call remarks allotted additional in

to turn the Jerry call me CEO, our now Let over Durso.

Jerry Durso

on actions you 'XX. will OCA year launch strong key months good established XXXX our strategic and the joining we of three NASH. a XXXX we updates build earnings and Thanks, us morning, on in Thank commercial base strategy preview conference business review for for took Nareg, first Today, in in for call. the us everyone. The first to quarter for our

through the process team we and its PBC taken and leadership year OCA through critical potential review regulatory Intercept, in for our our to execution in NASH to pleased grow our with As prepare the has for proceed to commercial pipeline. this I'm advance launch work disciplined

First, for I want treatment sales important the milestones May for and to our then performance our advisory a discuss pre-cirrhotic on meeting upcoming review to outlook our of OCA OCALIVA highlight We're as PBC. NASH in XXth our in preparing to drug fibrosis application I'll due for committee new actively and NASH.

body our Given the impactful believe it the clinical in therapy of patients NASH we've profile in improved has to through of risk confident become development of robust OCA benefit evidence need for pharmacologic program, urgent potential we're intervention. an and gathered the OCA

parallel, will we're look forward the PDUFA profile to as discussing well strong XXnd. which its confirmed progressing this At monitorable time, forward to committee. safety on of later elaborate target and In as manageable launch call. June our date the activities, We advisory the in OCA look on with action upcoming anti-fibrotic and readiness we Linda our same effect

strong net the our prior PBC turning of foundational business. sustained million over in quarter. the growth OCALIVA performance the growth $XX first our XX% evidence well sales continued representing We Now perform to of is PBC, recorded business PBC, to in in year quarter. This PBC for

factor which a consistent first growth we're in a OCALIVA trajectory. Importantly, our time key new is attracting seeing in trend writers,

prescribers of OCALIVA out ten four Specifically, time the first fact of quarter in XXXX total first in were writers.

foundational and long-term PBC in opportunity of several strong have for conviction reasons. we Looking business strength our ahead, the

seen with persist better than disease First, therapies. what OCALIVA a at other therapy we on typically on know that is rate chronic patients many

driven is business our to of our XX% XX%. be approximately patients by rate over and strong existing fact, continues at refill In

market that remains satisfaction high. shows Additionally, OCALIVA research therapy on patient our

intent therapy survey is satisfaction from report more highly XX% satisfaction platform. on XX% on patients of jumps to our have of for when strong XX% and of high two rating to which a patients on others remain to patient Interconnect, currently ratings, active with living than you would these recommend OCALIVA assistance Because years. PBC. therapy This OCALIVA patients been

that for providers or clinical market OCALIVA strong outcomes managing shows We the research also data future. of care their on prevent death. motivator to in to are among the prescribe intent PBC know is transplant liver primary treatment PBC when of Our goals a impact considering published therapies health the

the OCALIVA key assess gastroenterology study that with ability at six were includes our and presented analysis demonstrating POISE data This extension world meetings. year has real on biomarkers multiple of last of in goals We to open-label impact medical these OCA years liver through a meet health. sustained that published of

impact positive the strategy. is awareness OCALIVA the driving is of well XXXXs. established applications benefits only to IP greater PBC exclusivity OCALIVA our PBC part line world in OCALIVA position Supporting real the important on is protecting of in strong the PBC leadership second long-term of our an demonstrate and and outcomes, market a differentiator into therapy market in

to which in adds consecutive moment, long-term I'm will double-digit with space. and clinical this And dose development finally, the long-term Bezafibrate by our further confident market in program, for discuss growth of fixed our a and OCA strength fixed our Michelle OCA-Bezafibrate summary, combination. third leadership the In combination dose the opportunity progress sales OCALIVA's foundational business, PBC the quarter evidenced and for in position as

PBC, drive in and through our the new milestones medicines innovative continued us develop gives NASH pipeline to position programs. upcoming financial strong in growth our our execute on Importantly, optionality

to call over I'll turn Michelle. now the

Dr. Michelle Berrey

Jerry, good morning, and everyone. you, Thank

our on actively organization is for an As you imagine, meeting committee can XXth. advisory preparing May

is for with and patients evidence, nearly pivotal independent including X of database Phase analyses NDA interim on safety two of study almost patients four XXXX month from for a Our XX OCA REGENERATE XXXX years. body by positive robust a supported the study pooled drug

a anti-fibrotic was in consistent OCA benefit. to Phase the analyses, seen as first effect, and FLINT study show these the clinical X strong study, has anti-fibrotic In demonstrated

with is largest exposure, the potential in duration the well which safety of field NASH patient Additionally, our and chronic characterized the of supports the administration database, that provides a OCA. safety profile tolerability longest

there one which related various aspect of mechanisms important that to NASH studied in with pathways being FXR signs the NASH also treatment. of drug remember signaling are addressing while dysfunction specifically impaired exhibit Therefore in It's development, fibrosis. FXR patients is important pathway underlying triggers to progressive NASH

and is induced cytotoxicity. this decreasing regulating ways in meaning bile anti-fibrotic through It improvement does OCA mediated fibrogenesis fibrosis reducing signaling. acid drives an three collagen it deposition inflammation FXR restoration of direct and

for devastating committee move OCA believe disease. an we impactful advisory we the to approved meeting, this become potential our As to continue first and that toward has therapy the therapy

Based on that submission. to We believe the look with the date. advisory this target regulatory toward we forward risk generated, data the benefit OCA of next have initial PDUFA progressing our action month XXnd additional discussing has June and committee since we improved our

share commitment dose our to Bezafibrate. now about combination with PBC of innovating our fixed in I'll more and OCA

an about we're The agonist. first FXR potential of fixed We're dose excited agonist and making. the progress PPAR a combination

two is study ongoing the complete and Phase Our our interim now to from analysis planned X this we year. Phase expect X studies complete

timing an plan serum we to of a as on will and of one safety FDA. Phase in once interim biochemical an EASL tolerability those PBC At biomarkers the the have from as for X hand. on Pharmacokinetics study data provide Phase update data Vienna, as changes upcoming meeting basis the two the that combination the We analysis well serve the of end X dynamic effects Phase in meeting in X be with results evaluating will presented. of meeting studies

improve This information We in We of forward podium fixed Nash accepted believe dose to the clinical and providing a more and of OCA one PBC potential of PBC presentation in the optimize EASL medicine the best-in-class seven embargoed doses is the with the to an to presents that treatment for establish and of Congress. look opportunity benefits. abstracts each combination list. further Bezafibrate

years drive know markers PBC. action ranges. within clinical relevant in of the have many data well biochemical has have of to OCA Bezafibrate Changes potential Europe improved We with associated that and outcomes to synergistic mechanisms been from that and normal in

on benefits other OCA of words, XXXX, of and impact and options In with on labs. We we meaningfully combination the data clinical living fixed individuals survival, not PBC. transplant Bezafibrate its treatment free In OCA the improve PBC. demonstrating just lives, believe dose improved a long-term published may late that for

POISE on in support our While with open-label Patient will controls, for post-marketing from This our and include the program submission real post-marketing OCALIVA the FDA and evidence Registry of fixed PBC we from from dose year PBC. regulatory this supportive external fulfilling COBALT study world extension. requirements also advances, to for evidence submission our combination Global remain data track

At financial call a Andrew this for to the I'll point, brief turn over update.

Andrew Saik

a good and summary of to begin everyone. sharing ended morning, refer for March encourage release to Thank will quarter highlights financial I first our by for I you detailed Michelle, first results the XXXX. quarter. you, the some for XXst, our press

XX% sales line net revenue sales million which prior recording our represents our in to guidance are with growth, strong in compared call. pleased year performance with annual quarter, during earnings is last This in million we this midpoint our as First, $XX of the quarter. net the sales $XX.X provided in

by period lesser to to administrative over settled launch commercial NASH a prior first related million XXXX. in in preparation, increase we in our our ANDA which compared driven and XXXX, $XX.X costs general litigation, were approach expenses the Selling, extent PDUFA of to primarily and $XX.X June The was trial. to date period was as quarter million

cost of in This driven Research prior our million in R&D quarter decrease reimbursements. REVERSE million the and X and sharing XXXX expenses the decreased primarily development was $XX.X closeout Phase of study to from year by first quarter. the $XX.X

in of continuing million a million XXst, of quarter We million XXXX, outstanding. and and first a net notes million Interest quarter XXXX, of $X.X respectively net related $XX.X ended loss to XXXX continuing operations our for the decrease was from first expense $X.X compared the and in loss the a reported from of XXXX. operations $XX.X convertible quarters to is March

to quarter, typical of experienced plans in resetting heavier relative by medicare were last as cash we mentioned, first the gaps. to the a normal burn of coverage insurance year. patients we the impacted and As the rest We QX in quarter anticipated seasonality occur the than revenue

quarter, drop were as Additionally, by be end in end cash in the typical can this approximately seen a than the in to AP outflows quarter. of $XX from to in accrued expenses liabilities accrued of million year related QX higher

had investment cash, March Intercept of $XXX.X of million. restricted XXXX, cash and As cash XXst, equivalents, securities debt

million commercial As foundational business PBC previously pay provide our plan the Xst, to notes due balance a a for strength financial existing business we profitability believe in in NASH. use our XXXX. position the launch with we on us In our strategic an off grow objectives, mentioned, preparation and if FDA July to that to to meet summary, $XXX achieve pivot cash we convertible sheet the by unable are or approval NASH and to should including approval gain we

we to pre-cirrhotic fibrosis regulatory and revise our in Finally, later the to may XXXX our guidance NDA approval year, for pending OCA potential for choose due NASH.

the provide With will I Linda for that, launch commercial detail NASH. our strategy turn call more to over OCA on in to now Linda?

Linda Richardson

excited for into morning, ahead first NASH. patients provide Thank I'm due we treatment the who the potential to see cirrhosis opportunity advanced you, have OCA everyone. Good fibrosis for without insight Andrew. as greater to

doing analytics a and the to using advisory overall of research insight for boards. a pharmacologic robust third-party their population we've population, secondary urgent been patients and our The is market prepare subset providers and launch work market in are patient of and regenerate from is intervention. primary in and specific data publications and databases, healthcare feedback multiple where our grounded need one This strategies from NASH plans

the We've patients payers upcoming I in pre-launch and discuss included remarks. that will HCP's in my work

directly to our market In work communities marketplace we robust gastroenterology and and PBC. considerable program, delivering from of also engaging the knowledge addition OCALIVA have through hepatology our our research years

significance advanced the patients. by let's group digging Now detail of in both of and size this start of the population in more fibrosis this into terms a little

predict within makes which for two are currently One fundamentally cirrhosis in for an We urgent most cannot with priority. a are on to greater population cirrhosis. half advanced Notably, five progress risk this to patients and years. mortality risk at likely to patients progresses fact as approximately The these are patients reasons. patients their at fibrosis treating that we fibrosis progresses several these focusing

we've this our the size Also, segment. understanding of fibrosis updated of advanced

million near are believed group, starting Of The the XX, slide on X US this than here subset left. see can NASH you adult adults. of As funnel estimated the a slightly more is top to patients NASH approximately of diagnosis. NAFLD who the to have million XX on are have

expect diagnosed consistently XX would new the ICD should as NASH not of become treatments over As codes number time we available. grow cases formally that are used,

management We or of NASH to look commercial million these this without meaning in care focus patients. to We oversee efforts. primarily specialist, of will in be will gastroenterologist. the many cirrhosis the then a population X.X Currently, seems of believe of and are the evaluate fibrosis range that patients how NASH under of our the be the these primary advanced therefore a hepatologist specialists

Our NASH. in-depth has population to target due group readily tests. identified now specialists to with that approximately patients as belief be this work to with non-invasive these that without refer cirrhosis our be XXX,XXX we advanced these strengthened OCA the patients This estimate fibrosis using is We patients. can

on done XXX,XXX the from years number figure several This we've work is previously referenced based updated an ago. roughly

seen significant predictor progression in of recognition negative years, Over the as NASH. of importance past the increases and strongest disease outcomes of few fibrosis the we've in awareness of

with comparing fibrosis In as significantly a retrospective study their NASH among with without fibrosis survival reduced progressed. those and patients fibrosis was

research that with patients their advanced and Gastros fibrosis. recent progression this risk shows of Our clearly in Heps understand market

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I the We in who them? show importance identify readily importance can Later fibrosis. see and from complementary addressing in on presentation, these physicians the fibrotic the data NASH, patients also of stage of payers note how advanced will treating advanced but

the a a game the the This ACG/CLDF associations, acceptance potential or and is and and of joint a of important these is believe care variety option changer. the tests NASH Numerous very practice We as guidelines use now pathway. where endorse diagnostic liver biopsies. use NITs from of availability including non-invasive appropriate to publication, staging becomes NITs in element the of of AASLD an tools

and are in patients. without Liver in their settings indicated very own risks trials. office are leaders primarily space are instead NASH the clinical Thought not screening biopsies and for that painful have publicly biopsies invasive patients often NASH for used are used in infrequently

proprietary a like tests or scoring simple that specificity, scoring include used, and and FibroScan NITs like be ELF many with FIB-X of followed a increase guidelines the serum MRA. two-step everyone imaging or FibroSure such like simple sensitivity serum test starting and imaging To set done as FibroScan level ELF tests by test FIB-X, suggest with The by or APRI, a respectively. a or system the

professionals making Epic results. accessible identification it added of the care and availability these many In patients. important, it's in that records professionals into have NASH certainly to them confidence and medical simplifying health critical NITs even been electronic fact, use like test is but now FIB-X The many has more health of

four options. ATTs and and prescribers, are increasingly diagnose with to confirm shows gastros meaning market research and already that are Our and Approximately surveyed five target are two gastros stage. familiar NASH these they at hepatologists, heps in using using indicate NITs that least fibrosis NITs

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growing to stage NITs of the of aspects inherent NASH. those endorsement growing it biopsies the with drive treated. that adoption NASH NASH potential believe NITs will will of patients advanced The identification without as We the cirrhosis, impracticality patients using care considerations identify with need who patients and among and help facilitate exactly be all for to health the and KOLs to contrasted specialists fibrosis be of of ecosystem relates

the use of Michelle be the NASH. call, associated Earlier weakened to the will is pathway and willingness disruption in liver with Payers fibrosis. NITs multiple about in to an reimbursement processes in NASH space. our importance of To FXR of progression factor spoke reiterate, lead signaling also important in which biologic the access FXR the

inflammatory these targets targets directly The in in steatosis bile NAFLD majority fibrotic phases liver, other spectrum. compounds mechanisms. of OCA acid of occurs in and cytotoxic development the stage the late earlier which or fat NASH

and appeared food lipid foundational the understanding and steatosis hormones development weight. anti-fibrotic where fits the For OCA to example, is by consumption drugs produces. thyroid in Other of OCA demonstrated GLP-X into treatment important how regulate regulate metabolism. of Understanding the hepatic an disease effect that address

Using rate worsening the demonstrated double previously REGENERATE Phase NASH. histology, without but see NASH trial of liver only OCA evidence OCA supported reducing we liver our We've placebo in by not that in also the from biopsy XX X of highlighted data, by efficacy response NITs. milligrams fibrosis

baseline, of associated data anti-fibrotic speak. in Furthermore, data patient, FX the showing similar liver who is more key efficacy even Our stiffness with so measurements at considered of fibrosis. effect patients pronounced our histology more reinforced and NIT the to and findings advanced were like biochemistries

and This in important of compelling in concern the and see platform fibrosis on patients who fibrosis for in message reversal, XX had efficacy liver we parameter to carry that plan of also driver improvement nearly forward REGENERATE. month for comprised data biopsies baseline urgency the the prescribers. specialists XX% we Importantly, most to

size focused the staging prescribers receive treatment. appropriate So the specialty the to far reverse of of most among or advanced to urgently target fibrosis, patients, the patients the I've population increasing desire OCA on NITs NASH ensuring strong facilitate therapy, for stop availability

are in our compelling the leverage in effectively launch addresses The as our this and stop FXR help resources I'll OCA to to that in how planning on how an focus FXR landscape. fibrosis NASH and reverse role agonist and dysregulation we now to data. of space efficacy current knowledge and

As understand been prescribers, hepatologists, market are to advanced we and gastroenterologists have to practice launch done We've an leveraging providers. confirm target organization, our years working ensure and NASH knowledge modeling to claims the our databases for using readiness. deep extensive

our We've NASH to that four and pivot target maintaining support highest existing while potential three for HEPs business. to and easily are allowing NASH prescribers critical list, in learned PBC focus already PBC of us our the GIs launch a

these We existing have prescribers. relationships offices with and

our as differentiator. Importantly, targets of strength footprint, reaching achieved and a NASH can which field percentage at identified we this substantial be current view launch using

we and whether add regarding forces course, to access market will as we assess regulatory Of progress field through our the to decision milestones.

machines We've insights a space, also acid familiarity within started through prescribing, the proximity HCP obeticholic FibroScan second staging to when influence patients. and accessibility, our NASH loads prioritize based PBC NASH projected NIT of patient inclusion on facilitate targets to these to with regarding

it roles being this believe internal the us significant group comes handling that potential in advantage to to and paperwork. and the networks mover reimbursement in understand first the market play NASH. gives We staff We affiliations when gastro a

our the in sharing highly equally and reputation offices, show in hep regarded corporate field. is and strong research reps gastro we NASH that are our are Additionally, results

in the messages information. deliver that will is it but delivering believe regarding We educational OCA that who NASH, we not that just is

pre-launch market underway slide already with XX to are We prepare as highlights. the activities

at and programs with key We Congresses well. are is awareness major our using dinner as NASH disease educate HCPs website and to engaging running peer-to-peer audiences on up

plan We start the deliver education reps in May. to to which are our already we NASH field, in training

in are engaging teams educational also appropriate affairs efforts. medical Our

our Now I'd communities drivers launch payer hearing from critical are what we as success. and reimbursement like to are discuss of access

reimbursement expand field processes to share can to at manager our we plan team reimbursement launch. that I help First, facilitate

assistance hub including are additional this to front, We use a on of committed providing patient support. for the

stated NITs, and highlights, payers that significance HEPs treating the supported slide of and use are willingness advanced to and fibrosis of especially if this As same share patients a guidelines. sentiments by GIs they regarding many with KOLs the

acknowledgement be and reimbursement positive approval of an overarching need an is and all following to needed. may of different as potential conversations There final and pathways a a unmet corresponding the these label. NASH in productive recognition that access We therapeutics see for indicators

patients. the agonist has focused payers the fibrosis NASH cirrhosis believe of patients. In focus exactly yield the like this without helps we benefit FXR We where advanced to for understand our are the OCA potential discussions, segment on an segment appropriate greatest

proposition Regarding would final our with pricing for label, pricing NASH, make will upon up to potential tied for payers. final OCA along the be OCA label most we approval. about a to in value the full date receive a our that key the We'll with insights from from our decision insight

pricing we'll the pricing decision. We within falls the provide to our prices segment that At categories. assessing within are into that be XX our and of time, continuum drug context. depicts OCA range that the chronic options of Slide specialty believe able

and NDC and disease code, the PBC a is name pricing this XX OCALIVA unique separate with will is distinct consider for opportunity an the and milligram have from with we value As PBC, a to tablet proposition patients. which a trade NDA orphan differential

evidence Especially free and that world improved shows is second treatment demonstrated OCALIVA as has the real only approved survival. line transplant

Our with strategy the full best insight optionality and hand. to have remains make decision in

patients with excited without are of due who first to NASH, opportunity it. hepatologist are under the to to urgently for treatment potentially and the NASH gastroenterologist. bring XXX,XXX or advanced care about the OCA segment The cirrhosis the patient fibrosis needs as that we approximately market most a closing, In

diagnose over in a including three and NASH caused the Much of endorsement efficacy advanced years, profile NASH risks OCA a the safety of and greater changed better fibrosis NITs to REGENERATE the from of Nash shows understanding XXXX and has trial. understanding real the landscape in stage The a and patients. growing past by of acceptance

knowledge Hep, GI Paired ATT with expertise year. stand launch space deep our in and this successfully our Nash OCA poised liver to and commercial we in of later customers,

now the over back call turn I'll Jerry. to

Jerry Durso

In we've manage the a strong of you, progress committee Linda. the believe OCA the meeting and first position NASH made upcoming financial proud and summary, Thank we milestones, our including for quarter launch. as in our of in year a planning I'm in we're advisory potential for

now I'll for the team. questions call open the for

Operator

comes Piper [Operator Thank from Our you. first Sandler. Instructions] Yasmeen Rahimi question with

line Your is open. Yasmeen, please check button. your mute

Yasmeen Rahimi

much ask morning. so me the for and you you that congrats us Thank allowing for updates to great my on question provided this

therefore population? then You really the noted in maybe back any to advanced flexibility you discussions go queue? you above. FX into pricing, jump particular patients slide how very could I'll that the FX NITs, patient I And the recognizes that you pair if of the understand Could and and with of if And into secondly, chose help and says FX available have specifically identify current need instead one with the think us fibrosis.

Jerry Durso

Yasmeen, you very thank Yeah. much the question. for

As we're work here. obviously Linda doing progress with deep as we payers the indicated,

clarity. for just Importantly,

like offs We've that of the done our the is can in specific are to using work have available and will pull information outlined currently. FX world of analysis population. as there. it of bit a the quite done we're can on launch own This patient the additional you We've the also is which and cut and future that out of NITs. clear NITs. from to some the target the a published OCA, both be it people group put That for two defining don't the access that and some REGENERATE if usually data So describe utilizing we've as of work again, the the group real found is can in they we XXX,XXX slide

to Also out be indication. those importantly high with in to probability make that since that might to a algorithm, we're patients be outside have we're cirrhosis our sure we patients opting of also trying that expect

note So is little the from but the did growth it NASH imagine, by we greater population., like put the the past, two to we a and a in found in years, FX we the essentially growth is it's a as number similar non-invasive it out understanding is think can the last you this on as of based the both three epidemiology well and over disease. as XXX,XXX

a value grow, seen The it's subset We've is that with payers a productive talk is proposition. for similar, a that population when indication is group. this of our it pairs. we with We're our fact and it focusing currently but the FX potential that's place about on discussion

Yasmeen Rahimi

Thank you best AdCom. you're Jerry, luck the much, as of and so headed into

Jerry Durso

you. Thank

Operator

next One moment Mamtani for our B. comes from Riley. with It Mayank question.

open. line Your is

Mayank Mamtani

Good congrats and progress. our questions also morning, the Thanks for team. taking on

context world study OCA-Beza So love in that what sequencing at we have from combination maybe two years real on focus differences versus response you in ago, which the analysis also should on. paper population endpoints plan or you did from trial what did could use specific we a more stringent put interim that efficacy EASL. We'd setting. to the if solid a hear biochemical definition and clinical other any that And

Jerry Durso

it question, to Michelle. the I'll for Mayank. turn Thanks

coming, in present and we're but our Michelle? terms about. going a the with caveat of course Of that under EASL excited embargo at that data to really that program we're the we're information

Dr. Michelle Berrey

question. the for thanks Yeah,

We the forward at EASL. are to looking podium presentation

embargo, are but mentioned, regard the looking biochemical with at under are Jerry to all As endpoints, we parameters. we relevant

So similar baseline. a than population to similar advanced paper you ALP higher that referenced little patient population maybe a little also and that to the more POISE at

the So improvements. we really can see

well also the of be on set some our data we've importance parameters data take good range a will of driving but to the additional now in some OCALIVA, that clinical really to been publications look is how EASL the parameters in we PBC, transplant with able for at multiple multiple have that the that sharing and patients outcomes the into on we've that there trials both now and in upcoming from been to free real large evidence, have for normal are and predictive able great improvements about both at We we the outcomes survival. see some that world information predictive

couple a of So months. we data look forward to sharing in the

Mayank Mamtani

of if the implication time Great. definition, squeeze we a And efficacy any that I definition also reported part as preparation, PBC in a The required curious if the NASH to Publication. follow-up. expect that kind to reanalysis. of could if you is I documents It's you there's which AdCom think But the in improvement Lancet data set of also clarify quickly just see related. month's your and briefing if biopsy and in know, NASH fibrosis that resolution,

the question. I'll could clarify you Thanks taking in the queue. that If for and back hop

Dr. Michelle Berrey

so database And in the request safety with post-marketing at pooled all to document, we include regard from the the NASH our did FDA's data briefing PBC.

that data. includes patient years XX,XXX of So

database So safety for for relevant support for the to that's chronic dosing Nash. OCA our and potential ability clearly large

So, then be And clarify the book. included will to yes, that primary end the on point. briefing just in

So month guidance approval ballooning. without three for histologic worsening or one inflammation the NASH two endpoints is without accelerated least parameters improvement an at the as seatosis in for NASH potential XX or resolution at of stage of fibrosis current of of any fibrosis NASH draft either one of defined worsening

endpoint So methodologic with different a just reading procedure. the same that's

by late follows that the we central reader XXXX readers we that in had early or to a central guidance draft on panel XXXX. was So issued new used of two instead achieve or the one FDA consensus glass slides,

Mayank Mamtani

the Thanks panel for forward to questions our and month. look taking next

Dr. Michelle Berrey

you much. very Thank

Jerry Durso

Mayank. Thanks,

Operator

Cowen. Our from next question comes from Baral Ritu

Your line is open.

Ritu Baral

Jerry, revert by were like target Good question. wanted defined be I you ask and could and morning, wanted that population. slide I to that patient NITs. the for mentioned back guys. FX sort to to XX taking of XXX,XXX Thanks these

this see out risk. has conversations the terms been sort high ongoing KOLs that had around and about that we've frame we've Could low but maybe it. about heard the population with I'm we've conversations FX queue. the of of NASH this up you started the FX further Some slicing FXB, I risk KOLs as FXC. is thinking of FXA, versus XXX,XXX? I'll Thanks. loud, they hearing back with had And maybe those in with And get

Jerry Durso

Yes.

on historically more always of sometimes that's little the some say, So small NITs. these which there's been as talking histology of with everything based emerging, built populations data a you we're with bit obviously in overlap, has of datasets and in population some because

late likely are we FX or again, there one group of course we of straddling that keep be by by are to that like we category good a identifying XXX are are certain job sometimes who The that most early we others. an think be who pathologist patients by would, might to we But FX saying in described, cirrhosis. do is progressing FX patients a NITs of

Of in there ongoing. FX, on course, that liver are other of besides in things terms risk and going is true of category their in any it's patients other

fibrosis So data continually risk physicians based an and a in different and shades we've of population the data all sub on generated. the populations. FX FX, at these the broad around are looking But

the meet, But -- there think a we're always will to we is different We some and appropriate treat differently. feel the FX patients that FX which launch. segments. that be of assessing a subset it's in earlier the physicians the think But would REGENERATE. we've a of indication studied I Again, meets the a very, pursuing, risk that from in for are done to all a focus as than who place we the very us urgency be this greater work again, we category mirroring definitely

Dr. Michelle Berrey

who's know may Right Yeah. cirrhosis. half to And do? factors. KOLs X now X looking I at predict years progress patient and Can the would we say within populations can we tip the over? to We know. don't we that are What two more to likely in a certain

ATTs And talking are the patients where is think gastroenterology simplifying and it is. ensuring think them, where practical be But us ways with are the a involved to and probably that's way in as for we right you're later. risk So know now, the it you and there well XXX,XXX community good making into I I bucket to place right do about and field is because as are urgent an the associated the if going now. HEPs, in right really we may the they the go the refine

Ritu Baral

question. you Thanks. Got that And could this is do it. think that of last this just taking will for the at up squeeze Thanks if that. brought AdCom? And be a topic I angle one

Jerry Durso

we given risk the to around discussion do CRL. about the be So the initial history anticipate benefit and

more work from world. and the to agency questions specific our prepared Of data populations we've and questions how on get we're about but appropriate our the get the certainly the from when population, discuss to population. we're in detail appropriate learned for We'll course, we real the preparing appropriate closer, find what

Ritu Baral

Thank you.

Jerry Durso

Ritu. Thanks,

Operator

moment. One

We have Seedhouse a with James. Raymond question from Steve

line Your is open.

Ryan Deschner

on Good Seedhouse. Ryan Steve for Deschner morning. This is

Jerry Durso

morning, Ryan. Good

Ryan Deschner

morning. Good

earlier cirrhosis own your there that have And in We advanced have in some to target population suggested NIT guide are subgroups specific to this to protocol threshold launch? gastros you plan the to fibrosis reimbursement. particularly any without facilitate

Dr. Michelle Berrey

learnings But have would the the we're scored some were the there, for on that guidelines exist NIT at patient appropriate at data that that of patients graded, run say certainly the I clinical then trials we that and the ranges knowing kind screened we biopsy patients of how are against have we appropriate now. can stand benefit we and So the to look have take what general and our that so type. the of confirmed looking patients that

we've that guidance what that right range the learned we considering patient to population. tweak that ensure have may we and So tweaking those

We certainly have to we are wanting don't that population within. poor a sure make

was study positive Our there. not

we as I we NITs will our learn I data And as to that and that's biopsy think points patients. and benefit. data, think go our we the refined can as of all at compare get well from through these everyone's So more identifying have data

Ryan Deschner

terms gastro to from different guidance on guidance you Sure. into how delve relying just of the then far roughly and be threshold for or planning mean, And the sort they are heps in will NIT that NIT consortiums? of I protocol

Jerry Durso

guidelines. that's see our robust So we're cutoffs, where the you'll the own we've in informing that the And data. also but case not also upper learnings using we're it future we're looked course, the from at the data we've with published it's patients of also always identifying And on sure risk. in We're might the REGENERATE. that the at being the end be who

will a the it published get out launch. But closer what's what communicate it's set. learned we've we own is from really specifically and both learned combination as again, there more of we've to on our data that and So cutoffs what and

Ryan Deschner

lot. Thanks Okay. a

Operator

moment. One

Needham Stringer have a and Company. We from question Joseph from

is line open. Your

Joseph Stringer

pricing, per year. drug pretty Hi. pricing our a to question range Good specialty taking question. for wide XX,XXX morning. your XXX,XXX for A chronic with Thanks guidance of on

end what curious, label of or of going the types or around higher scenarios research type the other What around put the or would near end scenario XXXk that Just way? towards internal potential would range? the would XXk low end price put it

Jerry Durso

obviously we've there's ongoing. a Yeah. that's quite of work work done bit Look, and that

the and this importantly part proposition payers with discussion also on focus which continued that the we've think value on an with is specialists. indication, I of our focus important patients of already subset those to a are

going as of on So going into that we're pushing efforts patients the information the at pricing do looking take we'll information and to for more not specialists. be a we in to launch is decision as get course, be And look, launch. phase the to hand. the with full important We're decision

payers can that with part understand an So I input discussions interest those the are as you we'll we're at communicate currently here, all forward. them importantly, obviously move that input discussions of with payers fully information of that directly this in sure we while as the when point. have having And we containing And with know, are we're right understand we're to that well. make the need you all hand we the

Joseph Stringer

Thank our Great. you for taking question.

Jerry Durso

Joe. Thanks,

Operator

from Baird. with R.W. We question Brian have a Skorney

Your line is open.

Brian Skorney

Thank know first early just insight us documents have of have just that they is And in combo it's treating and have requirement maybe morning, I little the people related the also know sent reductions would in that I briefing registrational data be then people hope I into yet? pathway to what liver can taking you underlying for are my leading terms for guess would reductions for give the has a I'm of disease FDA on good at the ask in Hey, in pruritis. long-term everyone. to meeting question you you But statutory the may questions. send the the results, know FDA you some role the upcoming the wondering, OCA-Bezafibrate some ultimately indicated real X outcomes. quickly, them. a end I Phase requests, I that

pruritis? pathway FDA, the thinking that you potentially you based biomarker registrational sit through the you've clinical this do when of in would approach? Or with So reduction be see data Thanks. as another down be you with would the sort generated, symptom

Jerry Durso

So, Brian, book we agency. not do the one, the on briefing have from the first

the As FTC, on it question normal timetable. according you can the you early please? Michelle, is said, to the answer

Dr. Michelle Berrey

Yeah, absolutely.

that with that on for outcomes with been be accelerated ones up approval the have is correlated currently we follow suspect, term outcomes. So biochemical The endpoints, changes still will long-term important the confirmation. about longer a the pathway basis

important drug really forward improvement be symptom for individuals to that. half more second on and it at data certainly looking remain to is ability the We're Although conversations a of for come to look the this to lot year. would overall at EASL think sharing we in and critical the

Brian Skorney

Okay. Thank you.

Jerry Durso

Thanks, Brian.

Operator

comes from question SVB next Our Thomas Securities. Smith with

open. is line Your

Thomas Smith

Hey, guys. the for Good Thanks questions. morning. taking

any efficacy? request X could was mid-cycle whether or there's from there's meeting trial, whether and review regulatory been any point REVERSE if been this front, Phase Just from either wondering kind the NASH on clarify the safety for I at of you data the agency

Jerry Durso

Michelle?

Dr. Michelle Berrey

had December topic that really but data in in of submitted clarifications then XXnd. our a been the comment on IND with we submission December under the to with we REVERSE, have the there, And study So communications of package completed that since can't the with a was have and so analyses. lot agency and all did top not but on were regard separate line

those two in NDA didn't So the for we we've for REGENERATE. include not, reasons, it

are endpoint. for certainly be are However, analyses didn't population, hit population. But though I proposed even in excluding is we it as that patients earlier. didn't important through our we that patient cirrhosis patient regulatory primary the differential cirrhosis They'll Linda more think see with in forthcoming that that with some walked we safety population

Thomas Smith

Got Thanks. very That's helpful. it. Okay.

Jerry Durso

Thomas. Thanks,

Operator

JMP Wolleben comes with question Securities. Jon next from Our

Your line is open.

Jon Wolleben

question. Hey, good taking thanks morning and the for

time? like bit on what it's drug? that helpful over and fair But your monitoring are non-invasive payers that tests. In proposing response patients also focused been how a is to hearing a and responding spent using looks on of And on super time You strategy identifying you as are who's something or FDA tell well? for early about discussions

Linda Richardson

is Linda. the for this Thanks question. Hi,

the hit the requirements we're help can or of think regulatory very the in we're at reversal. fibrosis and we seeing talking approval, But straightforward about NITs for use which when I staging. and really look what the is we other one the

we very look stopping progression. also clinically at What is know is meaningful to reversal

thing a to cirrhosis, forward, the a So such can trouble, real and efficacy patient over regulatory move in be cirrhosis, eyes the get standards bit clinicians great preventing if this versus a flip the costs, don't when impact is different. on to and world you getting is they the

of That's it monitoring obviously monitor So part NITs to continue of and kind to patients payers to up their it be can how now. they're we're that will and to looking They'll see these routine of as be doing. use tests. well the used physicians as how at right

Dr. Michelle Berrey

at also advanced that the than think progress. safety the already started it for is monitoring does standards really their for are NASH. drug with they clinical the for patients they on If the it's cirrhosis, and more time that side, the clinical be our see they're same thought recommendations that using they following I someone really more were Because to they if same, drug they've monitoring would event so those they decompensation that progressed patients would that or discontinue launch. biochemical recommending we as have of our evidence of part they during changes would education that indicate then had that a the

Jon Wolleben

you. Thank helpful. That's

Jerry Durso

Okay. Jon. Thanks,

Operator

have Merle a from UBS. question from Ellie We

open. is line Your

Ellie Merle

taking for Thanks question. guys. the Hey,

bit terms the driving us going versus PBC continue Thanks. the total where overall sort are What's the Just potential new seeing of how forward? on growth? what that you prescribers to the about in elaborate pool? little you prescriber on prescribers, a And prescriber where can it just thinking ten out sort penetration of of you new PBC, four with and you're and of expect

Jerry Durso

Yeah.

can then take I'll a Linda she maybe and quick so on if that So, likes. comment one

prescribers quarter new that sign prescribers is far this of time our the to the a we gastroenterologists into life the expand effect. the of for fact fact having So being number a good XX% desired cycle that this OCALIVA, to is a really still larger of yes, first in strategy have the

see eligible of still OCALIVA. than less potential the received patients XX% We have

gastroenterologists. go. across the a patients bit quite So spread that They number. still large a is tend small to again, have number The a very there's challenge of are these to in PBC

the to it's to get growth, So are and and good that prescribers. in source the order team we been as to Linda effect see to plan new intended cause And executing. to have continue the

Ellie Merle

Great. Thanks.

Jerry Durso

Thanks, Ellie.

Operator

Our next comes Jefferies. with Yee Michael from question

open. is line Your

Michael Yee

or coverage. to Hey, payer And that have of visibility for around in of around guys. I'd to recently any on approved. in base go suggest case How profitability letting any up Good field One XX And think launch. be clarify in the be your I how biopsy you that. look terms bolus? work ask sort versus spend And you what was bolus the pivoting bit said morning. patients for months. could a six two. needs is last Thanks second of me approval the a the visibility was Thanks. patients maybe an your you ready question. to in about of to not and does in question appreciate or does was there that to go the case related of it that view I your

Jerry Durso

first and the take I'll then questions. can Andrew the second. the for Mike take Thanks, Okay.

So are up. who there that who their going the risk and is they specialists that with are patients understand previously have have been counselled NASH that

indicate to present will Nonetheless, pattern. I that while do scheduled is continue to the according visit probably urgency patients that work think normally that we their there. All might those

to a So anticipating quote, we're upfront willingness expect act, not in while a bolus to period. that there's

of mentioned, happen I is which course, over on the element depending think the one other time you decisions payer that the payer. that that normal

think I in might to prescribers most we'll approved, ready if anticipate you So highest to categories. anticipating a potential like some be seen we But the important warehousing get We'll and launch again, first. effect go we're don't we other quickly. have

Andrew Saik

Yeah.

we to know, guided thanks XXX XXX at the regard We're to that level. question. Mike for the to you spending year-end. the So With expenses, obviously

you well we've expenses. we the steady. out. holding within big that very quarter before, this change was We extrapolate don't this our see, year. can if said a careful range, We're you guidance been manage to As expect the spend And as

we're need ready, be So obviously to right? everything spending we

is how get prep We're an payers. and agency revise see We're to haven't And to ready choose field for build. we that know, What -- with we'll to working all our the guidance. doing, So work responds. point the commit if us force, is Linda's going launch doing We're hard and is the footprint know regulatory let the at let we we'll team done increase everybody wait we'll to infrastructure the launch. going. you to

we are. feel comfortable at But spend. with our very we're holding We this where point,

happens what asked if you pivot to we know, You profitability.

thing right we regulatory lot trials. do to first our don't NASH away. a stop the would would get obviously, expense be of to So approval, If down the that take

those are look then if we'll make not to things Obviously with able at right sure that organization later deal regulatory achieve the to but sized, we're approval. we're

that our hopeful speed are an and full ready ahead we're AdCom We with for we getting quarter. PDUFA approval and get here next

Michael Yee

and what you. next view thing? your is the market I term? two I on either Is Or that competitor the That may good case Okay. medium is I Jerry's base love this, on appreciate I landscape or there your mean, was on hear Thank by to If could the your super that is oral the would which quick ask be short view how helpful. think drugs a of year. that. impacts follow-up, that I in be would market one view Michelle another

Linda Richardson

I'm that. take Linda. happy Hey, it's to

mile this for deep with of inch patients us, the think exists I very really, wide market PBC. and because in way is

now I think in NASH. that

Jerry Durso

But Yeah, there. and is, the things. PBC in maybe jump preparing. here, and one common still Yeah, but factor take think can clearly is We're high in on there NASH, is Mike, Linda NASH of they're jump unmet we which Look, a I'll the that I both I'll need. PBC, look, both. then

a think the one information out here. is three have know satisfied there. or there educate this right is It we have about or be we one about an to lot talked lot. chronic that to by will, thing ensure apply NASH. drugs And two classes companies And and Multiple as to I a I won't mechanisms believe, about or effort talked

To that gets the patients a treatment continuum start treated. to way in organize

right utilization important therapies of the patients as the of of the opportunity potentially if the like need for be some can of clearly we So we objective is we that some in there's a where large of treatment multiple prepare we and unmet future a some there first. to commonality imagine in course, helping But chronic have here. for class out right development of where you get there be of NITs would patients terms the where lot messages the a there's common see

Michael Yee

Thank you.

Jerry Durso

Thanks, Mike.

Operator

question comes from RBC. Brian Our from next Abrahams

line Your is open.

Brian Abrahams

question and my overview. comprehensive taking appreciate very for Thanks guys. morning, good clear Hey, and the

have On you sense or what I'm you NITs? an population as out target it a the point, that XX% the fuller OCA sense of can us the then the do who biopsy is have percent around right you I non-invasive using at discerning from mentioned from you the FX you specific comfort if give And to patients there FX mentioned population metrics Thanks. guess have of XXX,XXX? diagnostics, curious a that for XXX,XXX confirmed NASH this is for more that that that patients

Jerry Durso

some These get So no, patients that getting that number. much it's code. biopsied not do It's then I don't think and a get for typically are not probably that always low formal different. the biopsied ICD-XX

patients on clinical it studies maybe except would looking tend we that the upper those it's out? question trying complicated number. where some or be of low we identification you that be can something biopsies around opt end be else. that a they're patients first comment Michelle, on around to avoided to do for the might -- Brian's And So know cirrhosis is to identify to

Dr. Michelle Berrey

Yeah.

using to patients criteria, the so excluding tests. They're non-invasive not is good bounds yet the who've So of the at really what we've identifying fibrosis. and recommended pre-cirrhotic progressed upper than more more

up. So excluding FX on kind the FXs, FXs and and concentrating of

You can use FibroScan.

the plus patient can to albumin events. even bounds that criteria, So progressed prior other some of that have the looking FibroScan of we and a you that But some sort help of may FXs. markers the combination platelets, at what decompensation call biomarkers of really using wet upper delineate

in our looked data at and the the good. we've data physicians are pretty particular that for And REVERSE study screening

exactly has So at are who good delineating and these HEPs cirrhosis. GIs pretty

standard that's So at for monitoring important going using but to why baseline, it's clinical patient practice. patients be for also identification

for FibroScan. will a to be You maybe be they progressed be know, and sufficient every to for haven't monitored to to three battery months, cirrhosis. six sure of them should they safety, a seen typically tests that And but both blood also for make

Brian Abrahams

so Thanks it. Got much.

Dr. Michelle Berrey

Sure.

Jerry Durso

Thanks, Brian.

Operator

One moment.

Our with from Olson comes next question Oppenheimer. Jay

Your open. line is

Jay Olson

and update. Thank Can how expect great. then you talk to you the address at I And Oh, could, this please. providing come plan AdCom a for the them? up to questions you follow key that about you I up, FDA had if

Jerry Durso

Michelle?

Dr. Michelle Berrey

The we've discussed. Jerome, Yeah, issues around the as overall risk. about were CRL benefit

what's changed at will looking advisory topic that we've meeting confirmation endpoint. that our between NDA this this anti-fibrotic be the and the So committee validated of the the submission that in December was second is prior shown with really benefit submitted efficacy, of

our anti-fibrotic very estimates benefit treatment what's seen effect. to double showing for the Again consistent placebo in

safety. The second element is

questions the some there submitted addressed been that initial be at with had safety that were the couldn't With that data time. submission,

yet We any half XX exposure. we exposure months now patients XX. The a three didn't reached have median have and was for and who month more patients patients about had times

database almost X safety in XXXX study XXX our Phase patients from Phase X studies. or XXX of another alone the patients the So

years of more a XXXX four of patients, median XXXX XX months exposure. patients exposure, or of So with

able special but the on risk, focusing AEs being those benefit really of So of interest. overall to review adjudicated specifically

in both is renal cardiovascular have safety disease hepatic that population events that And and excess on risk disease and have imbalanced AKI, shown specific no adjudicated low a very of panels and there's that hepatic in patient important So that's now risk experts is cardiovascular at all guidance safety increased cardiovascular AKI. and progressive. have safety, by for that the a we we fully those and of a

a using be about, important, non-invasive to that those clinical but that it to also as be things any should sure which continue illness, and tests make excursions the and biochemistries that. those talked patients progressed have at haven't drug intercurrent for regular indicate cadence the to like So time looking discontinuation be have of short-term cirrhosis, discontinued, need hospitalizations, patients to for would will short we've monitored term to visits

and I that's be focused will what think that a fully prepared weeks. address of to on in So just what is we're predominantly couple

Jay Olson

also development and to have drugs you. you in Thank helpful. efficacy for perceive research. comment Could as Thank it on any competitive other OCA demonstrated compares resolution And that might OCA's thanks market improvement That's in competitive you. position Great. in NASH in landscape? your positioning NASH both on and sharing how fibrosis feedback the the of NASH physicians

Dr. Michelle Berrey

Yes, absolutely.

at really So the when intersection strong urgency and physicians to population, the I particular risk patient our advanced of we are. nice more really data resonates the patient that a need with of think look in treat population, who It's that unmet progression. high in

FXR the is FXR fibrosis what And in pathway what talking happens we're then our and resonating. how in terms there data fit strongly and about and our this of agonism addresses very

population really most they're the to and concerned sense them that in it's think patient about. I makes

and that, of there has data it's at historically the a that, fibrosis. strong lot look we reception as very to So on been

to So the that the study. we've seen mechanism our in control fibrosis shown ties, there. we've speaking, efficacy OCALIVA we of even And believe, frankly

So anti-fibrotic in in areas strongly drugs. we very multiple are clearly

Jay Olson

Great. for taking you much Thank very the questions.

Dr. Michelle Berrey

Welcome. You're

Jerry Durso

Thanks, Jay.

Operator

moment One for next question. our

Our next with question H.C. comes from Wainwright. Arce Ed

open. is line Your

Ed Arce

Hi, me. everyone. taking for Thank you Two for questions. my

wanted I payers. lot been just know work you that of on you've the doing ask, to Firstly, Jerry, deep earlier with a I mentioned

preference confirmed coverage. differential And any I'm if And any there had only lot any know to much. are there those used. discussions restricted you unrestricted discussions there NITs so you've secondly, if in that is is specific algorithm a know I of coverage. differential you there combinations wondering reimbursement And or and strongest that support of payers there out those a with algorithms a sufficient so of with diagnosis support a perhaps could NIT would is -- different in wondering accumulation sort in if terms Thank of your for of that. data payers I'm be that

Jerry Durso

the start with we heard. front. on course, But maybe what get on comment can we've you will discussions, Linda, Maybe, continue regulatory which information ongoing of Ed. as the Thanks, more

Linda Richardson

Sure.

community. advanced of get with it to the biopsy our use think, resounded to physician story and with the there treating I all, fibrosis NITs receptivity first the as has has of versus payers

remarks the willingness of NITs, certainly in and to and my very into involved opening said that that, numerous treatment is NASH already there's the if the and by I use they've What showed groups we of guidelines incorporated have a are endorsed they from NITs, guidelines, these if guidelines think KOLs, they're that that the in guidelines. identification

They're market inexpensive. of et a really coming cetera. who space in every biopsies be et or may and NASH little impracticality potentially The a itself. prohibitive not there not in getting may performing of have bit cetera, There's patient I would into think on delay them is the

getting want something a the is that, is on patients between in reasonable I what is care So right think, that drug. all that aligned continuum whole this way And of are ensure they health to the audiences.

to how There differences incumbent use data it's at I which with are us. patients upon our haven't over look ensure the there recommend slight guidelines, is the that data right honestly to for preferred understand So NITs think us and crosses know why biopsy between right we or the we to and a how algorithm that heard, our now.

So deep to do there. work we continue

Jerry Durso

So more front. to on payer the come

doing about of discussions if another. And having or on basis. payers course, part are important we the sessions meeting talk of you in an ongoing group a the have on different sometimes obviously they're we're think and the things these along one the one with individual just the I as sometimes perspective underline, payers way and to who

the here. So we'll continue work and we appropriately deep update progress do as to

Ed Arce

Great. Thanks much. so

Jerry Durso

Thanks , Ed.

Operator

question. One It moment Goldman comes from Richter Salveen Sachs. for next our with

open. is line Your

Unidentified Analyst

approaches have target also that feedback you're how diabetes -- Thanks. you how be Matt with docs or about thinking you coexist the from morbid And share GLP-Xs? use any patients Have could like or is Salveen. used on Hi. for do OCALIVA with how on in feedback that payers OCA population? have will in of getting combination obesity you NASH Thanks. This other agents any in Could particular? resmetirom on this you within then are

Dr. Michelle Berrey

have I'll GLP-Xs. We patients certainly really own did outside patient first. your we of one we our take don't have and there. where on last have. don't was SGLT-Xs carryover population So There

the are that I in proposition the that like practical given you that mechanisms weight a used of clearing with is see really paired of the reduction, out an say anti-fibrotic working manner, interesting can from where for ourselves. an that fat actions standpoint, different GLP-Xs agent there liver

where patient NASH in they being see population. and In terms resmetirom the of used OCA

you I there think very, I advanced for perhaps comfortable are with. that But very see We'll how more it. there's we're of to the fibrosis, well go no, know, our people profiles with data. about there they patient think, that be going positioned strength feel

we to data use this safety drug, the population, that in efficacy understanding about services support It perceived with acid that on use of is to had this be managing we've fibrosis, just obeticholic the our profile our they've and but drug, that side also not understanding offer. shown effects, the patient how

patient open resmetirom really That's holds of understanding on I all really at this our benefit. just to and have we're package use our the greatest looking the it. a running Can't you whole bit that your and and having and efficacy to seen, of think, patients. focused population of would on where race we and where one It's point up. not But speak safety how data

Unidentified Analyst

Thanks.

Jerry Durso

Matt. Thanks,

Operator

moment. One

a from follow-up Baral We have from Cowen. Ritu

open. is line Your

Ritu Baral

Hi, the guess for follow-up. for guys. and is Thanks I my Linda Michelle. question taking

there Linda, talk can generating that cost may that Even you cost bring it to progression be that you start experience from Is preventing you this year discussions? have there treatment mentioned analysis extracting though discussions. table interim, cirrhosis plus Thanks. XXXX that published, from payer you to the to it's for savings even not can how As data you those payers. savings are in can though that to be and resonates. the

Linda Richardson

One to you, practical got share. you other and can things start can some then I've I of tell the numbers

Dr. Michelle Berrey

Okay.

that Yeah. Don't still there? was. know what You

that that shows focused on only on submission only is really is improved associated that strengthening fibrosis. we're prior outcomes know, of things the clinical and XX been with the the data focused has benefit. data, fibrosis the the changed in improvement with NASH between the that the which month you So the submission of But there, parameters is of key has one as histologic

data specific all transplant risk on that in staging and have liver have shown risk just improved in single those of now death. We liver and of liver and risks, measure improvements shown stage a not to have that and progression cause improvements mortality, but

those I data So the has strength improved. think of that

not yet at our looking outcomes are data. We

improvements go steatohepatitis share improvements you, in lot into in without alone specifics I that can't any the there's as fibrosis data show of a on going fibrosis, to over does Linda's importance the and certainly with Linda. we there. fibrosis But So think there of

Linda Richardson

let's of level population have think, the about has Estimates XX% Those with are in at that direct US $X.X medical NASH I a high first. distribution predicted Yeah, NASH patients a total take it of of annual the billion. in cirrhosis. cost XX%

So cirrhosis, once seeing dedicated patients they the maybe versus you're those population billion. to X.X tip into of with a lot over of XX% expense

it think not to in only not But health to about those it's benefits the side and cirrhosis progression from obvious when numbers, patients. also consequences inexpensive. management terrible you So but are of a the perspective, kind preventing the cost the from

in. tie back to you Both it. go When

kind the you baseline up. over times difference, study member a to and of related without with NASH there's costs per can month then cost done cirrhosis was cirrhosis year at looking cost two You and that per baseline follow-up see see you three the time going

doing what our it And I important. pair So that get trials is what's can the the and what sees with whether recognition other that currently think terms it payer tracking a not way very there's costing them, then of on ahead. just in work. payer or they're lens that and it's out we But we'll of community

benefits of that pretty the are strong. So preventing

Ritu Baral

Thanks.

Jerry Durso

Ritu. you, Thank

Operator

This And questions Thank call. there are disconnect. the queue. today's and in no for Thank you you. does conclude conference other participating you may

Intercept Pharmaceuticals (ICPT) 27 Apr 232023 Q1 Earnings call transcript