Intercept Pharmaceuticals (ICPT) 2 Mar 232022 Q4 Earnings call transcript

Company Profile

Participants

Nareg Sagherian	Executive Director, Investor Relations
Jerry Durso	President and Chief Executive Officer
Linda Richardson	Chief Commercial Officer
Dr. Michelle Berrey	President, Research & Development and Chief Medical Officer
Andrew Saik	Chief Financial Officer
Ritu Baral	Cowen
Mayank Mamtani	B. Riley Securities
Jon Wolleben	JMP Securities
Joseph Stringer	Needham & Company
Brian Skorney	Baird
Brian Abrams	RBC Capital Markets
Jay Olson	Oppenheimer
Eliana Merle	UBS

Call transcript

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Operator

Good day and thank you for standing by. Welcome to the Intercept Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Conference 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 Executive like speaker to now Nareg today, Director, would hand over the your I Investor Relations. ahead. go Please

Nareg Sagherian

Thank fourth available quarter on you thank full year call. issued morning website which us and press Good is results, a our today's we This at for announcing release our XXXX on morning, you. joining and intercept pharma.com.

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

Listeners are obligation such statements, of forward-looking as the these cautioned date by except of as to on update required and not law. no place reliance this which undertake only undue statements, speak call, to we

based of to believed subject These estimates forward-looking be to and uncertain statements risks a uncertainties. inherently reasonable, are that, and and assumptions although number on are

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

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

questions. call the We for open will then

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

Jerry Durso

I'm business for Intercept and proud significant quarter full call. and Thank XXXX, Thanks, made achievements highlight Nareg. our fourth Good the across year morning, joining today. to us our you on everyone. progress conference in

with sales $XXX.X delivered XXXX. we PBC, growth ended Ocaliva in was sales of million. performance our net U.S. and again over growth XX% double-digit total for This at Looking XXXX

growth to PBC driving XXXX of now we're quarter growth, the $XX.X year more confident year the which net U.S. sales, in fourth million continue the is as the We business. look our generated Ocaliva to of in than over ever XXXX, XX% prior in Importantly, quarter. and longevity

a remains of resolution as with there District second-line the more can was year. scheduled U.S. in cycle life case living for with our XX know, number infringement Ocaliva this February our added therapy. patent adding certainty benefit trial of We of significant the people a for of in runway Court Ocaliva who We that on PBC from the

Ocaliva PBC. the and in protect settlements reinforce long-term market The the exclusivity into opportunity we XXXXs have

strategy. PBC fixed-dose potential. of addition, its of In component we next-generation next-generation to forward are and is to medicine sharing on OCA data another our our progress We long-term combination therapy, about the this bezafibrate excited look which continue and year later our

our Turning now liver of to for NASH. OCA we to pre-cirrhotic quarter, NASH. NDA due end the fourth At the resubmitted fibrosis in

signed milestone NASH of agency hard personnel dedication work in study a community. January, is at Following target XX. major and our the team this point is action June has and and the here from physicians, Intercept date for FDA's acceptance Reaching PDUFA a result the of patients,

believe we investment antifibrotic planning readiness OCA milestones. our our now become taking impactful We're through rigorous advancing potential an has measured and while regulatory effect process the approach a therapy. strongly we upcoming launch but through program, has it demonstrated in confirmed review a the the progress to are NASH to working as

FXR this elaborate and in agonist trial. we hepatitis alcohol-associated on investigational lead therapy, announced in Michelle INT-XXX. strides indication this In program our Phase November, for the made with call. also later our will the We X pipeline next-generation our initiated FRESH severe

Notably, our the last was we of progress the made by year structure. transformation complemented capital

of cash on will year operating and nearly strength. million finished for of the we a be a with $XXX position from Intercept, work, this of result a XXXX we're pivotal hand. As year

with the I us alongside Our to PBC business balance forward in team look sheet This growth grow and the success positioning to financial and the performance year's and of we for NASH. commercial strategic business. drive our as year, ourselves optionality flexibility on momentum provide the last working while PBC foundational build

of through forward As NASH, we launch innovate these while preparing while priorities opportunities work our year in the progression updates OCA liver we regulatory the for commercial sharing on diseases. with continuing people throughout ahead. of review of progress as I a to behalf on our pipeline and look living to

call over the that, I'll With to now turn Linda.

Linda Richardson

underscoring market good in XXXX. only was Ocaliva's agent PBC. pleased I'm to morning, year the highlights foundational second-line performance another everyone. It approved the business, share Thanks, and position for of as Jerry, strength use our Ocaliva strong for for

We growth frame time year full the same compared to quarter fourth both last the for achieved double-digit and year. the

Our a a performance XXXX, notable return second by growth in of driven PBC was half few strong to the factors. in contributing with

trend prescriptions XX% as would First, We label as mark post the XXXX passed of IQVIA's half June XXXX. reported audit. our of the second change new-to-brand the believe this grew nearly we in during NPA one-year be by

While existing for and patients over for Ocaliva in speaks second-line patients with many of PBC. business XX% is by receiving it's solid the to to good driven growth new therapy see our need patients, ongoing

in in versus Second, Ocaliva specifically, XXXX new in we half see saw increase as dynamic the a is XX% ongoing very a and writers XXXX, reach second efforts new of result an our prescribers, writers. important. we of to increase a positive continue first-time see to More

start investment can and resulted time pharmacy to Third, Ocaliva. in award-winning hub our eligible want improvement services to treatment our We pharmacy specialty in fill. that our with network in continued through has ensure support specialty eight-day patients an quickly patient appropriate

Simplifying ones. patients. in of and and a our for communication of benefits new focus Strong sustain the the the initiate commercial patients Ocaliva and help engagement major at team, remain existing conferences facilitating customer field processes here with

patient and ALP kicked designed messaging urgency to the addressing campaigns Last HCP drive fully fall, PBC treatment. we our management need with marketing go each off and to new demonstrate updated beyond in

real-world outcomes for to gastroenterology HCPs, Ocaliva. detail, of taking the provide publication evidence that to our improved greater in began We proactively regarding presented patients recently strong some

additional PBC. studies, treating HEPs real-world the a anticipate and In outcomes the later projected of this have in and research seen new from presented of significance recognize real-world market were GIs once We data significant results the accountable studies. evidence with year. share market presentations when publications evidence real-world increase Prescribers we

now NASH. to Turning

We with commercial are engaging we all our go-to-market as strategy. key execute to against stakeholders prepare

continue payers We our refine as prepare thinking in to NASH. a potential meet with launch to for we

us on understanding access to which and are strategy. has our valuable We focused reimbursement gain and allowed pricing, needs into insight their concerns, overall

progression fibrosis be of research with NAV Market with cirrhosis. care key of of further stopping of and the the prevention prescribing for with three health action. that reversal without drivers cirrhosis of a will of OCA fibrosis patients fibrosis believe differentiating shows mechanism in trial all the confirmed professionals unique concern advanced our and We strong that antifibrotic address shown these areas effects of REGENERATE

specific covering we've base, awareness to our building years. Intercept customer presence are NASH current well-established for and potential PBC targets. for our footprint provide with us while within This our three of geographic nearly the also analysis, broad easily a then our Based NASH been and enable where highest relationships U.S. disease overlap OCA advantage. ones to the messages Importantly, six will field PBC on already existing prescribers competitive and four flex past

disease In the our meantime, continue. activities awareness

website the NASH. to on advanced with campaign, significant fibrosis risk unbranded due associated Our our hosts providers NASH Tipping educating Point

will also disease programs. our at congresses We initiating while key awareness continue presence

proud team In year. closing, PBC in to strong in actively team's and increase for the PBC The positive had future XXXX, our and and Ocaliva is we the franchise. penetration forward confident maintain and sharing our preparing performance progress performance our our remain a look updates throughout to in on commercial of market for I'm passionately ability NASH. outlook XXXX in long-term

to the Dr. Michelle I'll call now Bars. turn over

Dr. Michelle Berrey

everyone. in good our morning, and made development In Linda, NASH we and progress pipeline. building you, out XXXX, Thank program our substantial

new the first resubmission NASH, NASH. application liver OCA accepted FDA pre-cirrhotic to Looking and our fibrosis In at due for drug the January, of

We associated to liver-specific to are regulatory NASH disease. delivering progressed our to in of all-cause have this FDA-approved need progressed to thrilled of both therapy progression with patients NASH increased cirrhosis, a to goal first a critical closer this pivotal disease and address one for liver risk There's before the reaching point devastating fibrosis due mortality. milestone step to

robust NDA nearly from program, body clinical XX-month from of analysis and including interim the safety by X,XXX a includes least a X,XXX large for evidence robust development the four two pivotal study that is assessment REGENERATE study on REGENERATE OCA with NASH the positive years. from supported drug Our at X Phase patients subjects

comprise of of two studies improvement the parameters demonstrated XXXX. across the histologic or effect multiple shared analyses of of stage histologic that three score, REGENERATE we worsening antifibrotic and course without of consistent over NAS. study a fibrosis one methodologies, OCA the any independent Through that the two NAFLD least demonstrated activity at has OCA

rate demonstrated liver components. of the stage REGENERATE of to was double the In finalization and three placebo analysis of note XX result direct OCA any both response to of a FDA methodologies, worsening defined It's with milligrams reducing interactions endpoint that important prior this fibrosis the as of the histologic without statistical plan.

disease. and data, efficacy chronic shows safety well-characterized administration database, the the OCA the which patient We to is the that and tolerability OCA. has robust first NASH of with that the we strongest the clinical continue in to exposure believe largest of of safety therapy patients Nash potential with know in in approved fibrosis our predictor addition become In this a duration outcomes potential that longest is to field the profile supports

this assigned considers date. it as do of fully but confirmed advance June have through resubmission share this process. XX action Class date NDA. updates as advisory us a review for has that meeting a part II the appropriate committee a and additional We at target not anticipate yet as an indicated we FDA PDUFA We'll process, we

PBC. to Turning

continue this large data post-marketing be our These included the Europe. study, to of support sets in real-world for We fulfilling PBC. from and in requirements data COBALT, regulatory submission data and year supplementary U.S., evidence in U.K. to post-marketing will Ocaliva FDA a and prepare from

clinical Ocaliva. the The data we benefits have long-term date real-world to of demonstrates generated actual

had PBC treatment most goals free for clinicians. and which and patients living be Specifically, improved both OCA to decompensation transplant-free know survival, their with taking individuals the for we important

of PBC, Building on and are innovating in making to of our great OCA we agonist. commitment PPAR our with fixed-dose bezafibrate combination progress

Phase and dose studies Phase trial. well two X enrolled, a combination of studies of now Phase analyses our X for patients design from second. is of doses year. fixed selecting a Phase and X data study large pharmacokinetic as into will planned recruitment These the X this selection We analysis we're Phase inform fully sharing X and accelerating the One our dose and as later for anticipate studies

impact potential with mechanisms tolerability. that bezafibrate to the in predict show long-term that measures has of biochemical best-in-class PBC believe We're combination potential OCA key also this synergistic The excited has potential. of to lower combination the improving outcomes while action further and we

happy agonist to next-generation severe in updates or alcohol-associated lead indication our a provide I'm Finally, on FXR INT-XXX, sAH. with hepatitis

disease chronic the liver is as liver leading And of on alcohol-related transplant is rise. background, disease liver the indication cause For in currently for a the U.S.

people in for the We this Despite in incidence no are several increasing who XXX there there therapies sAH a could the are impact. indications develop of potential which could approved U.S., make believe disease.

this us sAH However, great compared gut to OCA. for with FXR agonist a to provides a ratio liver with different initial opportunity

In announced and FRESH, AH. our called tolerability, INT-XXX, of with evaluating the in Xa of patients proof-of-concept safety, pharmacokinetics November, Phase study we initiation efficacy

was site the U.S., continuing and to first XXXX, and France. December sites add in fresh Our U.K. additional we're activated in

forward our recruitment look Phase of this sharing As X additional to study. updates we XXXX, for We February advances. as completed program have

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

Andrew Saik

Thank Michelle, morning, everyone. and you, good

December a please I our and for financial ahead. discussing detailed for encourage our the forward had release sharing the summary plans year our to strong of for XXXX. refer results year XXXX, quarter to ended and look I have very to press our We results fourth you and pivotal a XX,

will I on relate we'll XXXX. focus they call, for highlights guidance the to also as XXXX, this For and provide

results that remind financial international I would completed non-GAAP of the begin, statements, I business financial fourth was the the quarter year of year our discontinued In the July please information, to As full note on that our as our first everyone business business X, for the operations. year. and divestiture been moved full divested like include our and you half to has review divested

XX, pleased the for PBC quarter XXXX. were in ended We of to the in growth December Turning year and highlights the very fourth Ocaliva with full XXXX.

U.S. Our was XX% year for growth the the Ocaliva prior over fourth sales quarter in net quarter

million, sales year, compared full net non-GAAP the adjusted $XXX.X $XXX.X For U.S. we Ocaliva U.S. net net XXXX. with worldwide million to of million reported in in total in $XXX.X total sales sales

in investment in million million XXXX, a million full $XXX.X by compared offset primarily increase fourth increase year by was costs, NASH compared the million general for were to expenses XXXX, in in in NASH expenses expenses administrative The and an operating SG&A on driven Touching launch and selling, quarter $XX.X XXXX. of XXXX $XX.X period-over-period preparation. were launch personnel-related $XXX.X with to decrease preparation. in in XXXX

million development $XX.X was NASH-related R&D and from $XX.X XXXX sharing the cost quarter. expenses to The in by the offset prior quarter decreased to decreased reimbursements in $XXX.X million lower primarily decrease Research primarily lower reimbursements $XXX.X lower and recognition costs and driven expense million fourth the credits. and decrease year in of cost from million of tax by down driven The in were XXXX, by sharing partially XXXX. was R&D NASH costs

series financial a transformation the senior were of several to business transactions our costs the private international our In spend. structure, our conversion which votes. to was We of our a transform XXXX strategic Company. program and of NASH XXXX, X/X executed year capital for repurchases of included sale approximately related secured of R&D

as Company annual our dramatically reduced during decreased repurchases Moreover, XX% $XXX.X by interest. result Regarding of approximately cash convertible the notes million. to the secured of notes XX principal XXXX, was convertible a the the balance

with will cash the XXXX, million anticipate redeemed forward year. year-end, with had in on FDA of later cash XXXX be million $XXX our notes and July and XXXX debt. equivalents OCA cash move flexibility We this million to our At the the outstanding $XXX expected ended decision For NASH financial expense we regardless business will in and be on $X Company hand. as in interest cash

Turning financial to compares for XXXX. $XXX.X of $XXX Ocaliva to $XXX net to million sales we in to our XXXX, guiding are million which guidance million

$XXX from business. sale business international to approximately the which excluding million For expenses, to XXXX, the are continuing million non-GAAP we XXXX adjusted our to in million operating $XXX compares non-GAAP operating guiding in $XXX of when expenses

the anticipate years, year. to lower the relative what Similar of we higher and in rest cash quarter prior XXXX slightly in to first we've utilization seen revenue the of

expect sales that at the insurance beginning and plan Ocaliva as with year. will usual patients be first seasonality We faced quarter the gaps coverage by impacted are resets the of Medicare

quarter for also in from a preparing launch the and use to work other approval greater related activities annual in We cash NASH anticipate due potential expenses. to first and

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

in forward pleased XXXX looking XXXX. to are a with we summary, In strong our financial performance and

existing solid financial position believe in are sheet potential on grow our flexibility programs. support launch advance hand a that financial balance current to and continue cash pipeline We business in and our and our gives us the Ocaliva to NASH

now operator to I'd Operator? any turn to the that, over With questions. it for like

Operator

Baral first Ritu Our Instructions] from line comes with question Cowen. of [Operator the

Your open. line is

Ritu Baral

things the we the you Michelle what for of date and you resubmission, are things? has the guess wondering given sort any these like communicated meeting we're of the AdCom. review tell you time? at to all of of flying last be FDA topic any like the are going since where going the mid-cycle blind AdCom further you they're at range point to be could it, a coming I Or to thinking should have

Dr. Michelle Berrey

Ritu. morning, Good

that So, focus advisory committee be meeting focused we on do of risk. would anticipate overall the benefit the

those convey have intend for know some conversations since have areas NASH-TAG. are communicated focus and with at specific addressed in the them. We presentation CRL that the all we of certainly to the We there NDA the areas again at our we had AASLD and that multiple were

of earlier of that with anticipated the safety feel long-term can the safety and a drug. administered more a analysis areas their second address be around specifically and confirmation benefit given any antifibrotic with, robust addressed of drive, the much to the all concerns which and that the We we be database tolerability have of concern this the we chronically would

it's years have in that important we safety tolerability. of to and So, demonstrate that order therapy

Jerry Durso

indicated your as question, don't I more ongoing, is point for Ritu, AdCom in to one remarks, confirmed but guess a the date. prepared have add in all yet her the Michelle we there, just prep to

Operator

you. Thank

with B. comes Our line next Mamtani Securities. Riley Mayank of from question the

is line open. now Your

Mayank Mamtani

-- a just have following question. I few up the on prior maybe

NDA As to communicated on hold just agency acceptance wonder are the part planning And they is increasingly to it FDA I an your was format. that filing, does requiring -- of letter in-person the by clearly Adcom? you

do how you have PDUFA purely So I June couple then confident by XX of getting follow-ups. answered the date? And a

Jerry Durso

a an as to Yes. is AdCom. I We a of working prior typically, guess we'll we come on those have we that date. speak the the itself, weeks the PDUFA date. have date And every there to the existing confirmed none are in yet, handful context but PDUFA indication can't of AdCom

So, of prepared. if forward, get additional course, will agency. the appropriate we're And information we'll moving be as from any fully it provide we

Mayank Mamtani

PBC, Could strong what by Okay. may hepatologists they very the apparently OCA driven guidance NASH cap? data you're with And for may you for you patients. that on seems share having new PBC, had have also also the then Do on have prescribers. like prescribed you new that these but overlap you care perhaps

Jerry Durso

Yes.

fourth So in versus half of you where said, and the of Matt, growth us. saw year we good quarter. feel the is the the growth focus a year quarter about a area first and half strong on both for in the as the do, XX% second for Clearly, with performance the acceleration an we this in PBC, the long-term

in on years core been a advance how with Linda of first as details the of really prescribing we for PDUFA being of provide see have commercial do we that audience and also many the potential NASH. NASH some working key now, planning the prescribers for several We deep physicians can the part large

Linda Richardson

four PBC already within NASH call our cover analysis. the of potential now list. Three exist top from we our potential out of right Yes, prescribers

but over PBC six as in years in prescribers Ocaliva target know So already that you new have we're established also the bringing same with relationships audience. past

the that led So PBC work launch. the we a -- efficiently that we're into we with very comfortable translate feel NASH, potential ground work will NASH

Mayank Mamtani

my thinking combination later to report the on unique are you some to therapies thoughts what might you class. you data be design Phase Phase in X provide drug it. maybe position currently final in intend PPAR approved Got a FXR question year. X/X on you that two this And Could pursue the since in just

would be early, deal? thoughts just it Phase I but your hear So know great to on X it's the

Jerry Durso

one, Michelle, to please? want do take you that

Dr. Michelle Berrey

question. Sure. Yes. Great

until combination state the excited are therapies We we potential unique And the with I we very are to data on we X have out of we conversations have Phase two combination in OCA much the the FDA the Phase really bezafibrate. But those fixes all feel detail with a PBC. for for plus about to give in as to our coming best-in-class for potential of the you is PBC. review position have the potential here exciting plans hesitate X.

this underscores it to So commitment again, really long-term our innovation space. in

Operator

Instructions] Yasmeen with [Operator question Rahimi of next Sandler. line Piper comes the Our from

is Your open. line now

Unidentified Analyst

Yas. to report? the pricing any? versus on is discussions for And had And with recent your of about in NASH thinking support differential is PBC? that, type ICER This if you you are question thoughts pricing Emma have what on My what payer that, still are

Jerry Durso

overall how ICER. we're Thanks, view give can Emma. Maybe on pricing thinking about I'll then and Linda on comment some

will on the final choose NASH towards full and between way. those the are execute have steps ongoing up-to-date take for and to some all pricing with key Ocaliva a should launch work a optionality course OCA pricing that payers, we're a information, right of label. once strategy right and work including prepare all you as we would But pricing includes that the dialogue to So to continue we we as decision imagine, doing we our have

separate with we things with work, our including NDC, that important that about discussions option. foundational date. first the with payers PDUFA years. to had anticipate with will, So, separate would be be going of to a think been PDUFA date. all share the dialogue the the get We'll the payers again, strategy give course, we going We've it's us And for the I launch the more to brand, payer, back updated inputs. which thinking those the before are And as closer several

current on it then you So a we've of the would comment Linda, with can in-depth as ICE. lot We're work. need perhaps revising context to and done

Linda Richardson

implies. that and model, the It the Frankly, it therapies. Yes, course. of approach disagree at question. standard constitutes an that we available different kind evidence data we an look a which within acceptable with of used report, not applies generated the were specifically, of for exclusion define and Thanks the does approaches of model, the draft data several when inconsistent for the set

data So An Phase in that? what do only put X both but I for X Phase OCA includes it mean X for Phase Madrigal. is, by example and data

frankly, X not data not did fibrosis information it And are robust available we notably OCA. And the of it even for then data November worsening use data safety furthermore, to in a though new AASLD and the present It all as presented have we endpoint, the NASH, this the at include that XX. improvement at publicly doesn't Phase REGENERATE. does set shared and NASH-TAG incorporate primary without XXXX. January analyses that available, updated We doesn't in full

and returns from there. we there's see in have some goes that a we how we'll of So of with it consistency But lack model. are kind approach recognizing the

Operator

Thank you.

line comes the Our JMP from Jon Securities. with of next question Wolleben

is line Your open. now

Jon Wolleben

you the ask included necessary? is would X/X about do to I'm NASH said R&D I'm for that's wondering, of incremental I much much OpEx be there? wondering included, wanted think how not And expect Andrew, if same if you And more was for Primarily you then XXXX how guidance. proportion think, SG&A NASH. XXXX. fully it's that

Jerry Durso

John. Thanks,

guidance Andrew, that in the managing we're gave we're about can thinking OpEx intersection to of the our making of the for we investments as we paying also into but prepare you NASH, right continuing lot attention go how earlier. right a sure a you maybe think, with, are ensuring manage We I way, responsible to NASH investment the have that context of in

Andrew Saik

John. count think of right it about so operations when sort Yes, I to gave probably from in July. don't last the year sure. international year, $XXX Yes, question, reason around you was and Thanks our cost last spend the we way sold that our the the continuing million for

So, XXX% it the to is year-over-year is really launch the about then. related think way increase to NASH

targeted So, prelaunch external, that's $XX payers, So, we've to things And you've that NASH. got basically right? looking we're is about million pricing. we're $XX at million at like looking

not at disease We're a PDUFA meantime get to in to until date. looking We're infrastructure lot education. adding our the we

So, external you as it's spend we that could continuing go. going we be up ratchet all to to evolve as or With our ratchet R&D, of down we're sort know. to regard pipeline,

reverse that that like means be more to will So helps. R&D is XX% to XX% NASH materially but relative year. this if reduced spend our which is NASH done, but spend going slightly Overall last you're see on and flat, going to year down pipeline, be

Jon Wolleben

helpful. Very

Operator

Thank you.

Our line Joseph comes Stringer the next & of question from with Company. Needham

Your line is now open.

Joseph Stringer

NASH would if Just to in looking and ahead, desired market just OCA types the updated for? NASH patients your with get label, on drug thoughts approved your NASH you of segmentation, pre-cirrhotic on the wanted what getting

Jerry Durso

in Thanks, Maybe can Linda and if she chip start Joe. Yes. wants. can I

I best about when OCA. look, we think we think, would position how

We more advanced antifibrotic patients. continue on and the to focused effect the be

as we're in with theme, these of we you've getting stakeholders, heard be for And what this do from we're phase doing the of research what would anticipate, back discussions updated so market updated continues I preparation. me the as deep a to that think while all you we're

to of is And including, of from where identified treatment. reported the it in out we and we continues we we that of showing would the really, zero efficacy. means themselves the both amount last year the -- of that likely have patients be in part that the advanced is OCA, of greater some importantly, through level most latter profile noninvasive seeking who showed the the the higher really So payers know most the physicians analysis urgency towards patients on the efficacy in patient

the that on also that that already said patients specialists in those direction. the already those in the example, For under the GIs. FX as would we're of of of be of subset Linda focused goes are most response same physicians And questions, phase care and [indiscernible] seeing We one in to today. earlier initial in

So, group we a of those I good prescribers. of and have practices and individual those think understanding

to anything add So want Linda, you on.

Linda Richardson

Yes.

patients, think the There's folks over with probably estimate use fibrotic with X.X advanced patients NASH, are patients million only urgency to XX and diagnosed, that's have the calling I with combination of that by them. been these been on treat million there again nothing to right? over a roughly percentage, we physicians the but adult about noted small actually

to that So treatment an therapies following diagnosis have in of comes you increase see on-label the ability and lots and discussions.

and We the cirrhosis. of to GI advanced diagnosed HEP These estimate a NASH have that approximately are XXX,XXX patients. fibrosis under or diagnosed continue are currently care without

and we in the be and have the So need from calling have patients a launch we'll that data best mode, we feel that those that most reside in set. offices the on

Operator

Thank you.

the with of comes line question Baird. next Skorney Our Brian from

now Your line is open.

Brian Skorney

on two compared can to it's quite bit for acceleration that trending guess XXXX, is higher been about of getting year-over-year, end where to I you XX% guidance, the years. last increase the which it's for think a just maybe guidance frame Ocaliva the how of almost

more just that seeing you might can So there? that in for NASH? characterize high you're And what get you does end anything the include

Jerry Durso

Andrew, on just maybe start that. you

Andrew Saik

we're XX% overall. and Yes, Again, to really gave center to is as Look, put Brian. X% effort kind growth. to where the of growth continuing of range comfortable our into in growing our the We line focus guidance we're that is to energy to that and tend internally, top sure. the target our Thanks, guidance we try with

I you that on the that remarks, gave NASH. would reserve we to is is I probably In my guidance prepared unimpacted What Ocaliva back that the say come mentioned would we noted right by that we more and approval guidance Ocaliva. secondary give the when get FDA. and NASH from at and of we reissue guidance that a point, impact any include that would from would if blended And on

Jerry Durso

were there be Brian. the right year of we the Ocaliva we're data, context Yes, beginning get research out all that to prescribers of to real-world know they is as publications affairs dynamics, But that and important that the in second know data a to that the add in talked We just their line outcomes. prescribers. of hands the appropriately getting came just in that that I the it potentially utilization of we half terms those of the thing indications, commercial And in about doing, increasing we're for emerging can the other would sets it from only think the some from and/or those data last medical market we about into starting of year, patients. publish late quite look, plan. on The second data the

Dr. Michelle Berrey

noted, Yes. layering to year evidence half Jerry we market as think data. bolus saw And test that data the last of second exposed are growth. writers, when are people have And right. We that with the out that we And say, now, of note research all to in as we've of new et and is accelerated distribution we our that real-world demand, I and this the seen the cetera. predicted coming thing of

of increase and as we project anticipate prescribing, in share new of we we significant data. Now or additional to have, presentations allocation see real-world evidence a and Ocaliva,

about years outcomes, patients data of bilirubin, evaluate lives, POISE that be and have see we look Ocaliva. said and we've on physicians we stabilization treatment are like. from awareness will actual always and the complete are the talking AND our from that they've publications to able patients, looking maintaining up we of not reframing labs. frankly, the These management not preventing does fibrosis way progression, really are only and five the picking that those now that And but data important got at things, that disseminate, with what benefiting we're PBC

Operator

SVB comes Our the Thomas with question of next from Smith Securities. line

line Your open. is

Unidentified Analyst

Tom. on PBC additional follow-up, Mike the you when a Can then some And on factors you any, the specifically as remaining for targeting where are gating in XXXX for This if for are provide you submission? just are what, discussion, color quick with and regulatory submission?

Jerry Durso

that, please? Michelle, can take you

Dr. Michelle Berrey

the Yes. Thanks for question.

year as top well results, we supplemental been the which, planned an our about have the last the as we which of we've agency So discussion as control. discussed, include external with content NDA COBALT would in lined

of PBC databases. on comparing Komodo we've who So study, patient the global as from the those and as within We've two U.K. external bases. data OCA as looked different to group well at registries, from were patients the released -- patients database a COBALT

about So, discussions agency with the we've inclusion in there. been

or gastro We independent and about publish December data to liver data we a XX% with these We're did consistency depth striking releasing completely death. to also be to most these reduction seeing the is data the thing sets. transplant XX% in will in as planning the real-world The leading cover evidence. decompensation sets last

that excited plan here. really would those data lot the first the know include are of our real-world we significant sets. That in non ultra-rare This interest would is We a there's So, condition a submission. submission. be about evidence for

the that. yet timing on haven't of given guidance exact We

As for group, might in with we you preparations sNDA. and PBC so small understand, a pads, are NASH two on the parallel working the

give more that we'll So, question. Thanks the for guidance as closer. grows date

Operator

you. Thank

Capital RBC with of the from line Abrams Our next Brian question Markets. comes

Your line open. is now

Brian Abrahams

able that talk about recent your And just thinking to been NASH A but expiration there. question you setting should OCA's settlements you've in one do, potentially the we versus out in how just still extending Can in be exclusivity all OCA to to confidence PBC about level the maybe the on XXXX, filer of setting. that remaining applying given IP. then

Jerry Durso

Andrew? the for question, Brian. Thanks

Andrew Saik

sure. and the getting we we there so a Not Company that the filer we're is great get value out judge, happy able Brian. same the going litigation jurisdiction, was to settlement. the to patents Zanera Thanks, extremely look, same those XXXX set the fact a -- for on can't but it XX% outcome positive of additional It's IP were Pharma. separate would such Yes, it's of Yes, there, Look, is a to real a which That's the current same in the speak win out trial. Company. for XXXX.

over start scratch. completely IP ready an fact The the and Zenara the we we We're is never Company going prep. right, for trial, to we're our all set, good outcome, the enforce from same news the would for we're because it's to ready did but have work, all that predict vigorously. to did

In NASH, approval, terms set. fact that again, we assuming same that's of the get carry on to

the presumably, It's very trial. But It be comfortable it a been same file different again, completely against people would it, through IP. if it. will we're We've the with -- patents.

the have with that? with would we want as So I have Ocaliva NASH. you know, comfort same to level add we we if have don't that to Jerry, of

Jerry Durso

Nope.

Operator

Thank you.

of Our the Jefferies. line next Yee question comes with Michael from

Unidentified Analyst

P.J. is This on for question Mike. from today. us One

landscape some of how positioned have on evolving the you span in competitors comment Could the competitive is Ocaliva of So next up and. involved and your to us Phase view is bit year. X is little how data the coming a this over

Jerry Durso

so clear. So I'm PBC landscape I about that just competitive talking assume you're on

Unidentified Analyst

Yes, PBC.

Jerry Durso

in of me, Yes. get Maybe and a can comments a Linda deeper. little then from couple

in we I to long-term ourselves a position think importantly, effort PBC. for continue

We have leadership there.

think, maintain indicated, is to leadership. goal us give that just I more and settlements on certainty And Ocaliva. runway patent Andrew the as Our

better exclusivity And but opportunity runway only not coming generation provide then we FTC with and there's IP the the therapeutic combination. importantly, and potential have more the potentially solution also incremental next a to the because on

for a how So the for X play get good to do as potentially therapy, work comment think position in we you feel evolving. some entrants ready this I Maybe can that And the Linda, and come about ahead. to and our second-line now. is we on we new long-term see data us Phase

Linda Richardson

we Yes. are I growing. obviously, incumbent, mean, we're still the

the have We goals. changing prescribers way that's think about new the data

only second is in about lowering we're new is now right it probably or two long-term do And we are real-world people We have what just on reinforcing this trying evidence. the normalizing year, beyond is to the discounting more say line, what it patient. scores, and to the not come the our ALP or really publications so. goes really And impact

the we is we able this only and labs. and And data, But studies, repeating goalpost. lives, and in in the communicate data are generate. ones will what and multiple are continue are to to move that not Again, impacts with we in credibility we that to the it the space, credence to commitment market, important, second-line that and gives

if so evidenced have We out. have second future in the ability day by strongly And engaged groups feel accelerating growth we the our folks cetera, of to also is we guidelines, still We're that a NASH there call game a and as making have with on growth in with half. and launch. organizations we're lot we day in et patient the are these

the Our plan is into carry that year. to forward

Operator

Thank you.

question next from Our comes Oppenheimer. the line of with Olson Jay

Your open line now is

Jay Olson

INT-XXX. use progress. I'm program. the Congrats alcohol fresh for clinicaltrials.gov in the that curious on participate It on trial disorder patients must says about

do patients so, And you the and to potential study? manage will the the consumption during could be allowed plan alcohol alcohol if consume that So on outcomes? how to have impact trial

Jerry Durso

Michelle?

Dr. Michelle Berrey

a great It's question. Yes.

that critical the hospital. centers outpatient France after we study, of and we the to As have immediately this to U.S., really what And area. commit we many designing outcomes really patients program across is experts for these were U.K. this worked in being it's release with the their from for an found

So the on course, this of continue follow-up in then for program. but trial focused they their hospitalized would is patients, outpatient

retention that special hospital, We that follow recovery, do I see to think don't early. these do patients making it's of are first the patients and -- closely centers these working, up lost certainly but the of within after in sure these we find and in who months with trial general maximizing the recidivism, patients that, treating in that we period their in alcohol recidivism have have in after couple the from release again, consume because expertise

Operator

you. Thank

Goldman line of Salveen with comes question the next Sachs. Our from Richter

is line Your open. now

Unidentified Analyst

Salveen. This is [Sherlock John] for

briefly referred past. the this You to in

are thinking So patients treatments the for how data ones from FX in compared three fit the given patients the to as demonstrating the in [indiscernible]. like market efficacy given greater NASH OCA emerging as about well product from data you

Jerry Durso

Yes.

think, of sure the positioning question data deep value I incremental being FXs we continue and work stronger in I to part our the is efficacy see understand that can an this the out I the I the in advanced market context correctly. to continue there. and this in do other we understanding start the So, overall confirm of that given in the important on look, all of just got population mean, make efficacy I question kind proposition.

other play effect consistent antifibrotic that OCA might and know different be of look there are here We mechanisms where also at that you clearly working drugs have action differently. between

well-known population. updated So these that again, of I in more the is that overall. plays we context, pronounced is that high need of think in OCA that The potential profiles out including most confirm advanced the populations unmet consideration advanced unmet are everything profile there an need other to learn more and

of there asymmetry information is available. an Of course,

experience therapies, and of information, safety know would about as less the all there's we So lot particularly believe think of the put improved we we benefit-risk expect, efficacy a we've profile out. first of the the OCA. And we profile context have we submission. about emerging The importantly, you when other we with in OCA when are consider from OCA that longer-term the now the have that

is and to it have of speaks advanced to population. more experience chronic market safety in monitor that we about in guidance the dialogue around to important One and that regulatory talk think opportunity the the I longer-term believe hopefully, well right over measure therapy, ultimately, And what appropriate dimensions the both where again, we time.

unmet address any time, guess defining class, who over that NASH would NASH important this will OCA segments last I of just be takes the always the of towards the class chronic out of point there, needs. approach I is chronic to right in in stress level the for So and the for multiple look, and drugs need right clearly, high. it patients success patients is segments different therapy, introductory and and are the high we're working have unmet for an

Operator

you. Thank

of with comes question from Merle UBS. the next line Eliana Our

now is Your open. line

Eliana Merle

by number or diagnosis, given NASH what you might there's what horizon as will diagnosis and adjusted conversations guess, with other payers? a and patients. been NASH for potential payer of undiagnosed as be therapies be getting Just view this approved. reimbursement seen the or large do potential And of any the guess pre-commercial you types in the say, of step-throughs I in landscape, they from payers, that initial sectors types commercial you and recently are conversations, on needed any of of potential the class I trends able potential as to feedback your terms topic biopsies to have mentioned us a terms on restrictions what the just or of you

Jerry Durso

dynamics couple Eliana a the for of question. thank in have Maybe to you Yes. mind,

of commercial all to in obviously, As in-depth with And on more we're closer plan a come get PDUFA. work. would our the way plan the details when I look, indicated earlier, we be to formal doing back

monitoring continue Nonetheless, right? I see to larger key think play move of continue payers saying what utilization dynamic and for of the noninvasives is noninvasives identify of of to different variety patients utilization ways momentum of There's noninvasives. with direction, right there and utilizations KOLs what a to looking this the do couple themes right out. in the we understand is good and identifying which are clinical There clearly overall is a that are are which the And progress the the consistent there. the patients. One for are practices,

And payers early us I the has subset a is we're discussions in think about of together to potential been right? about to the that way find more which right the themes payer indication. and a is with big utilization the payers, of beyond concerns the one working one your the the for find of We're advanced important patients. productive really population. indication, about with always talking talking We're our talking

advanced us So population productive starting point of actually think subset that a And it's and about I good more a discussion. our of that the indication. a talking great identification we're gives

with pieces we taken final communicate this of et one will of Of our of the be I details and finalization equation. on cetera, the course, in closer approval, said, payers, last with be an last as that the will And just dialogue strategy. back ongoing we as come get as we'll more would course, to the price, with the decision point, and

Dr. Michelle Berrey

the the acceptance that, discussions, of to add five IT might about four or and I thing only we were broader. unlike Eli, when this initial is also ago payer idea at point, The is years talking

easier biopsy. So per to patient the an that and of the on time the plays to into trying pain and get people path frankly, expense

available an feel and and earlier work. where help access really with find from NITs were being to to really the that -- our appropriate I should patients of significantly advancement is before from moved So different advanced like we expansion has different ways

Operator

you. Thank

Our Meacham line the next with of from Jeff America. question Bank of comes

Your now line open. is

Unidentified Analyst

This is Susan Jeff. for on

on there the isn't year, position, this if interesting accelerate business books the development to you programs which stronger are business do cash external external Given development And internal in. any Company's opportunities? expect

Jerry Durso

Yes.

funding lead you we're imagine, that can we're INT-XXX, for always indication and to making the cash this we that but with for have important sure do work as hand trying looking the morning, discussed also we So we're managing given externally we're internal the good a opportunities, on ongoing. programs some appropriately that

primary internal And assets We're combination both should for also importantly, the long-term our for should indications be next-generation the in will looking focus. fixed-dose additional PBC of those sense. for it it make

cash also drivers. way our that the we'll in sure investment our to we're continue evolve the on growth while pipeline we right the focusing So, make and

Operator

you. Thank

follow-up the question from Mayank Mamtani is Riley Our with next B. Securities.

line now open. Your is

Mayank Mamtani

review to any biopsy might looking to their draft So been of endpoint definition cetera. or more suggest for XXXX changing the that Michelle? NASH Has there being Anything be document, mechanism maybe that go indication NDA specific, et agency guidance scope question. just beyond one

Dr. Michelle Berrey

we lot great interest a now to, publications have coming the was Linda on and of as tests. Well, seen some out noninvasive

viral this only reason that, in getting division and and recognized would on for planned liver said trials. participate NASH, focus alternative and hepatitis histology. it's biopsy. the in patients think interim providers is community to that decades a is relied to I agency by agreement in really now certainly we that GI would analysis with clinical by those to the the our that for histology the and biopsy have an Really on look first Having

with the to We're opportunity that opportunities. results now excited histology about the with upcoming we're our confirm and antifibrotic seen benefit, analyses at we've independent it that that confident two discuss agency

though. out does draft it think I as point guidance remain you

submitted our being we our but analyses NDA. and the are So, modifications have see question. to as Thanks some are more that, we that may with been the data for submission confident in reviewed,

Operator

closing back Jerry? now, call you. I over will the Thank turn And to remarks. Jerry for

Jerry Durso

for today. joining everybody, thanks, So us

and the of but think that lot morning, a Intercept, the reiterate, I'm for the have long-term of clearly the XXXX. to an of ahead. forward performance Intercept is achievements year growth us to really in and both this of extremely ahead look Just the through that progress work sharing fourth updates I important drive continued quarter to year us, proud delivered I for definitely we up we've what discussed team and as set exciting We

have everybody, a day. and thanks, great So

Operator

today's Thank you This concludes call. for conference participating.

You may disconnect. now

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