ICPT - Earnings call transcript Q1 2022 | Intercept Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Intercept Pharmaceuticals Q1 2022 Earnings Conference Call. At this time all participants are in listen-only mode. [Operator Instructions].

As reminder, today's call is being recorded. I would now turn the conference over your host, Mr. Sagherian. Nareg begin. may you Sir,

Nareg Sagherian

update, you. Good on press for us and thank announcing website on at interceptpharma.com. morning call. This and business results today's XXXX a first you is morning, available our our joining quarter Thank which we release issued

statements, financial we discussion, programs, approved our prospects, to these Listeners and our product clinical development I'd Before regulatory commercial note call, matters, our strategy, regarding during begin to including and be will statements our certain financial and cautioned we are on making forward-looking risks are These inherently place are believed like future that guidance a based forward-looking statements, obligation only and reliance undue performance. not no to reasonable, date the update assumptions to number to of on such be estimates forward-looking of statements and uncertainties. as of that, law. this which statements, although uncertain and by undertake speak call, subject we except and and as required

Financial and with Development necessarily our not Chief risk filings discussed and materially cause actual prepared results all of Medical Officer, Andrew the but this Commercial predicted Today's are periodic our Dr. release our Jerry Some, in public could forward-looking Officer, or begin differ Durso; press Chief Saik. and our remarks will historical Officer, by statements results President from Berrey; anticipated in factors our with SEC. the call from or our to CEO, President Chief and that those and Linda Research Michelle of Richardson;

allow addressed. initial to questions. take questions Please to question be then yourself will We and all call in to order for the one time open limit

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

Jerome Durso

good joining morning, Thank Thanks, call. quarter first on us XXXX Nareg, earnings conference for our you and everyone.

growth this net the through compared Intercept, I'm proceed X% for worldwide sales, $XX.X quarter. transformational team Ocaliva in We first with first XXXX. quarter made the million of that in representing progress year our to we the reported pleased As

U.S., of Overall, quarterly we're more While XX,XXX expectations. expected, previous year's COVID-XX and focused on saw of to sharing on impact experience than slower and growth a the we years patient as deliver in versus with line basis Ocaliva Ocaliva we continued With rate in the revenue and last our quarters given update. for label cumulative a worldwide performance of strategically to adoption data compelling our Ocaliva. was PBC, generating support growth long-term

over of from to number Given substantial patients continue I could in treatment, remain grow the this who the second-line business confident to term. PBC long benefit our ability with

in of transplantation the larger Turning which liver to therapy. people significantly living U.S. most include III We're NASH. interim our to growing cause a data analysis in XXXX. study, Phase than from need analysis fibrosis improved NASH nearing with data the due is completion set urgently will of and rapidly new line REGENERATE top our the NASH

the in first Phase III understanding disease. in potential treating our As new to and this forward OCA's of furthering look these data delivering NASH, we company role analyses positive with

June. in to pre-submission FDA meeting target with potential We continue the a

cirrhosis III the NASH, quarter. NASH, OCA track third evaluating top Phase compensated in trial a to patients in second readout with Our for REVERSE, line on due and is

on also pipeline which our progress made programs, I this elaborate has team on call. Our earlier-stage will in later

to yesterday. the we made now Turning announcement

to support continue the this traction, employees ex-U.S. Intercept obeticholic trials for future Advanz U.S. globally rights manufacturing and Ocaliva closing of the outside release, sales net supply the will in receive be royalties PBC of manage global in to our pursue the the will our press the saw global in be indication. NASH you Upon Advanz Advanz on our the any packaging, distribution should under to transfer and the all authorization supply has for markets of for we'll the Pharma will marketing of to clinical Intercept acid rights agreement, the our including this international INTERCEPT outside the obeticholic of a from commercialize current office outside operations, and maintain Pharma Pharma terms As commercialization acquired the U.S. Also, and of and Pharma. responsible U.K. U.S. responsible Advanz therapy though our an to in chain, the quality majority organization, will markets

to colleagues and international community. Advanz tomorrow proceeds Since this We I've CEO, with our drive for future working been be their a closely to this strengthening seamless We transaction that financially financial this our we've the bettering our want I'm role over strategic of growth. core and positioned X.X look I to advance to our a last business for move and to that Advanz been the diseases. sheet, and U.S., healthier Pharma a lives growth significantly of ultimately consistent by focus transition. the support will expand outside we commitment us NASH, the the ensure a to is priorities, allow we've should building people company's Pharma in increase world throughout launch balance the benefit will continue assumed the international Intercept. laser-focused organization, to multiple strengthen non-viral potential Importantly, with also, Ultimately, forward transaction liver pipeline. on of progressive to for employing the team was know ability pathways the foundation support Ocaliva for PBC years. successful their the inspired will in the be for contributions including invest the to thank our U.S. of deal the to And with our

Andrew details around now the recap, of agreement. the Andrew? before earnings with continue provide our we will additional quarterly rest financial Now,

Andrew Saik

everyone. the Intercept the will upfront a To to and the provide subject more adjustments. capital customary color Thanks, Pharma, Jerry. morning, million agreement under consideration this, of Good of on with $XXX in amount other receive working Advanz bit terms

contingent to legal Europe. regulatory and Pharma from upon other $XX and we close X Advanz approvals million to months. expect receipt an closing X orphan in pediatric will of receive of customary We Subject conditions, to extension an exclusivity additional

assess as impact a invest launch the Ultimately, second of organization. I'll commitment the call successful. us we sheet XXXX our strong also close for suspending potential flexibility should we and over earnings quarter to NASH balance It the ability support U.S. a manage to of Linda. us our transaction to as a financial gives be the our gives turn With call. reflects Jerry this priorities, a transaction As our in revised providing timing including result, that, to after strategic our the are anticipate during likely financial on of obligations. debt Linda? We and in guidance agreement we guidance and our mentioned, this

Linda Richardson

those sales process the evidence of this U.S. I'm XXXX, new Andrew, further would Thanks, just physician will sales Ocaliva. and person, through phase seeing In the occur of of I $XX.X to process requirements evidence and start pipeline patient are migrated total aligned QX $XX.X with up visits the historically this to we a interactions U.S. U.S. growth at and a of expectations. in exacerbated turnaround of QX million, morning, nearly we few in patients and pattern year's as In the patients XX% national recent dynamics caused 'XX, last much moving enrollment seen that decompensated be good we and return next the for seasonality to of comprised hypertension, everyone. growth which $XX.X and number specialty network prescriptions. new will the transient this prescriptions are in also and reducing verification the believe see large label million our market to our in In by portal of in quarter now new continue business eligible in QX PBC weeks, in was the Ocaliva performance is We year. of We by trending link Ocaliva plans, the included number we've U.S., migration and that the of show pharmacies, both entering to U.S. quicker remind with which a share this drive sales first are over ex effect XXXX patient million, that Advanz, year. update delivered new quarters. patients. net pleased patient of in patients worldwide of of sales employers, replenish on Current March. we our this time that PBC that in benefit everyone

regions. on In by international first Moving growth our to strong continued saw patient we new driven the starts. quarter,

all with for overall the period closely that outstanding moment same PBC months, many sales business, when year, would market with the maintain made performing I especially drive the were last the take we to penetration a higher like ability our above net had performance them. has confident closing, contributions and increase to the to opportunity our work budget. XX countries acknowledge in remain team last to positive than international a XX% I've In over long-term outlook growth, and to business. the Our

the PBC, and While an we additional considerations. of mortality. goals marker patients, consideration addresses will has liver care and higher PBC been important in in avoiding that optimizing data recognize and a believe improvement for morbidity lowering of includes it long-standing We ALP as outcomes improving transplantation prescribers become

this committed evaluating be are will data believe highly type for differentiating. We we to which and of Ocaliva, generating

at over and approved from additional Michelle of Michelle? As data the continuous from we data real-world the the presented role as will of plays PBC move COBALT, to turn important now I'll Dr. for ASLD last on Ocaliva the with call second-line year, the therapy registries patients through messages XXXX, PBC. new a provide role information we publication evidence, only Berrey.

Michelle Berrey

on our to supporting Thank everyone. I'll our as updates you, updates pipeline. work as generate Today, Linda, few well providing NASH on PBC, in our on and development Ocaliva evidence a good be and morning, program continued

Looking PBC. first at

meeting someone and of sources make on and disease, substantial data prevent to are therapy clinical on evidence PBC, Ocaliva mentioned to measures. end-stage when from beyond generating these living the we liver year chemical the to focused present Ocaliva trial the completing setting last clinical that to progression real-world decision-making the both the The we PBC the transplant-free of from databases individuals trial a publish quarter, As COBALT positive eligible, of which survival not benefit death, their show To that open-label statistically community. we which the generate POISE transplantation study end, did analysis with leveraging the were help III and Ocaliva. we later clinical liver for longer we extension, receive they PBC is Phase multiple data, clinical very regarding on ultimate on to to continue feedback positive therapy and goal These long-term expect events that those this to are year, impact benefit IV were physicians PBC, from to external different last in who but Ocaliva with on individuals Phase receiving data from difference for has sets liver compared pilot in outcomes. at showed pleased

data year. submissions will included these EMA our support Importantly, to of in study, half the this be regulatory COBALT, second and both FDA and as post-marketing for

communicated, COBALT previously available we've associated therapy. a of retaining especially commercially multiyear a with we've our placebo-controlled there's As closed in patients because study, when challenges study,

a the We including expanded events liver indicate the than new hospitalization COBALT, death. primary toward decompensation. are clinical compiling earlier that clinical includes for endpoint a liver demonstrating benefit final events, has transplant primary progression of from endpoint and higher primary that for sensitivity endpoint data The available placebo-controlled original Ocaliva's new

weeks line data and when top on in analysis We coming look forward completing them available. to the are sharing working

prespecified compilation of patients data COBALT our from Ocaliva data randomized patients a who with will received comparison sets. include Additionally, from external

outcomes we study, real-world For with leverage COBALT called our Phase the from later the behind these trial closure intend include initiated Ocaliva's to the our collectively this important Heroes, evidence we've of retrospective Cobalt, III impact extension outcomes. reasons and supportive open-label in Along studies on POISE regulatory which real-world as to evidence two submissions clinical data assess data same from year.

We're of Phase study to new III sharing look analyses results. from Now, the on our data REGENERATE excited and to completion nearing these be NASH. forward

the assessment will analyses the around submission, patient safety new include of X,XXX who've As X the more therefore meeting and the and OCA's years of than safety intend A we a in REGENERATE. NASH. scheduled with provide in X,XXX of on June, a potential currently on these years will the reached discussion is to the continue database much data X,XXX nearly compared pre-submission to more comprehensive now insight in profile for submission. benefit-risk reminder, The structure content patients FDA and prior robust

we X,XXX potential has expressed of data XXX FDA different or including histology include population in analysis resubmission. The populations Although recently our primary NASH, of non-invasive population final interest analysis in of NIT, on the over the tests will interest for original details mirror totality a additional for plan, received which subjects interim on our the will with data feedback subjects.

the consider entire new which includes will analyses XXX population, the subjects. Additional histology

can any patient with review, population any As FDA within evaluate the agency submission. a

toward III We Phase continuing from top a line compensated quarter. line data top study NASH. late-stage only study, anticipate active REVERSE from We the are to data delivering work REVERSE to third also our due in readout cirrhosis the in

Phase clinical We unprecedented. will the the analyses, we these REVERSE the assess results these III in ultimately, dialogue we in role have once set are agency data will completion we is with ongoing field. of amount REGENERATE data and in our accumulated of largest NASH data have trial of Overall, generating in upon with the hand. And the the

on Moving our to pipeline.

add screen fixed-dose PBC. our combination continue patients and sites our II U.S.-based OCA We bezafibrate for Phase in of clinical to study

continue dosing In evaluating OCA-beza of international II the addition, our is Phase combination. we enroll that to study regimens different

Phase in selection study large these will better Our dose design X the our the study the trial. the ongoing. and I potential for exposure drug-drug of remains Phase and III studies interactions data combination Together, characterize fixed-dose any to inform U.S.

our Finally, about in additional to I plans open for We call our study forward this turn next-generation track on indication and the agonist, intended now IND INT-XXX financial comprehensive over the Andrew sharing information a look weeks. we for to year. update. development Phase are for coming is have will Andrew? to INT-XXX, ongoing, an later our and I FXR

Andrew Saik

quarter. first issued Michelle. Please the press results release we financial $XX.X recognized you, for representing the our over quarter, of quarter Thank our first in the today to ended March a year earlier refer XXXX. X% Ocaliva growth summary million net for prior XX, worldwide sales, In

typical plans of of and and the net resetting anticipated, of experienced Our the worldwide QX net we sales U.S. Ocaliva by In comprised ex million were net were U.S. patients year. million. a $XX.X insurance sales as beginning impacted coverage in of patients, QX as U.S., the at Medicare $XX.X sales gaps the of seasonality

cost adjusted This expenses million million prior respectively. was we quarter, were $XX.X $X.X as continue operating GAAP and and million decrease quarter $XX.X versus expenses focus the management. operating $XX.X year and Our non-GAAP a the million, for of on to

financial operating SEC depreciation. for our operating stock-based under to is expenses regulations. of this issued expenses compensation Please reconciliation a this our reminder, adjusted As non-GAAP press exclude release refer and a and Non-GAAP earlier measure. adjusted non-GAAP a measure morning full explanation

$X.X March million Our cost was XXXX XXXX. ended of in the and XX, sales quarters

sales ended related primarily XXXX XX, of packaging, of cost March Our materials consisted XXXX and and for the expenses. labeling quarters

was to possible. year XXXX, to were by of in decrease business $XX and general costs in selling, expenses ongoing as and as quarter. The down million first $XX.X run our from efficiently Our operational administrative quarter the prior the primarily the million efforts driven our manage

from to the first efficiencies was million ended were $XX.X Our drive Interest $X.X prior the the continue quarter for research NASH expense $XX.X progressing as in year of in program. our quarter XX, quarter, development March we XXXX, expenses million million. and while XXXX, down

loss expect of for $XX.X XXXX. cash interest decrease in based compared $XX.X be full a million quarter we $XX.X of We XXXX, on quarter loss the the current net to to of first capital million, reported first approximately structure. net expense a In of our a the million year

am quarter important XX, management on cash summary, our March history. commercial and cash time in the pleased securities investment performance, continued our in cost of In sale positioned for which with $XXX.X As Intercept's is well million. available during track first this XXXX, debt of with cash, restricted and equivalents, were we I

PBC, investing positioned that, our like NASH and any the well operator With to growth development continue furthering program over FDA and of the to are in We regulatory Ocaliva with I'd Operator? supporting and turn for it to process now the questions. pipeline. our

Operator

Sandler. Yasmeen from of first Rahimi [Operator comes question Instructions] Piper Our

open. is line Your

Yasmeen Rahimi

Good them the we questions then, you to be FDA my questions. And data FDA so you are congrats order well the with motivate see kind had to deal. to for is meet first to planning you've come then, as data is back of morning, provide new overview Or do with partnership data to and Advanz in meeting June? Advanz as comprehensive partner Pharma. and next start for to and the team. release Two your of with off to questions. and the going And U.S. regards for taking thank with want and I'll thank NASH steps? And the after taking interim second Maybe, the they are question for geographies? much What And a seeing Pharma in Michelle. quick you. One on you ex directed the in the

Jerome Durso

question, deal. Okay. question Thanks, then, to it back the We'll I'll with right come the first Yes. Michelle on flip the and on

Michelle Berrey

Good Great. morning guys.

as soon So aware, on data as the is have We line material they're have company calendar as those be we the pre-submission you're soon certainly meeting the with have releasing we data, share. top as the and those would FDA. as that the to data for do ready that

tables sure ready the so different around the that You in that aligned structure a meetings to meeting listings, hand, all populations are don't lined figures submit. They data in those the and their of have to making are and get have because are those there majority conversations, the you to planned have have can the your well some hand frankly, the pre-submission interest of company of agency that up submission and companies and before. have data actually, on of

that Can't hand. it. say you'll So we those the those much as have more data again, will we released as about but about in moment, specifically we at have -- hear soon

Jerome Durso

the that to would they with commercialization we that were as We would U.S. the data, think data would the the the we around regulatory or we're it the deal did territory, upside able Advanz them on NASH, provide this global Obviously, right structure how we important in in determining outside as whether from and would was to for be then, of in make the a in to the in And potential they pursue on NASH a considerations now, preparation -- decision. Pharma benefit a basis of NASH. Yes. has have developer,

OCA successful and of with felt should good the of So U.S. royalty Advanz of we the strong about availability NASH inclusion be securing outside double-digit pursue and

Yasmeen Rahimi

Thank queue. in team. the I'll back you, jump

Operator

Baral from question Our of Cowen. next Ritu comes

Your line is open.

Ritu Baral

morning, going for go reading this exactly, what am Thanks patients everyone. many And primary patients just can the as just with total I've I been the will have you're I at have of how Could sort guess, us, question. Good to resubmission taking the as we right, drug. numbers? about then, point? part through the a Michelle, be tell treated got And patient FDA, to of far X,XXX end you discrete REVERSE. question

Jerome Durso

Okay. Thanks, Ritu.

Michelle Berrey

Sure.

FDA to of talked what so, over So in mirrors their original in part in a as which -- interest or of main of population lot we've the that primary see, last been submission a area the populations specifically, submission, dialogue again is -- they we've the at about year lot about wanted XXXX. with the the of looking was

ITT part readers. XXX patients the read So that by that of central were analysis

as mirror use So we as we any population, alpha. that long don't

we And that for of have are XXX. the both subjects histology at a new month that's that in includes really XX. the of looking data that have a baseline So all They, interested and critical. course,

the both be and that that original would that, of be central and read analysis has primary analysis, but pathology the submission So both from be would line. the new the the reads top part -- consensus another will group the

population at about. subjects X,XXX. We talked the That's out have total we've safety also who that are

X,XXX months. are to subjects have out We now XX who

with X,XXX So that's data. patient safety what population our comprises years of over

again, substantially approval I submission. -- not endpoint package robust is the accelerated in the it endpoints, So was little straightforward an It with with submitted This a complicated. a more methodology, gets surrogate resubmission know well XXXX. including as to than what submission surrogate This several XXXX. is same population that analysis the interim a as importantly, tests, focused endpoints. noninvasive primary full is that analysis but towards a using mirrors on on continuing that clinical a original an new move from certainly submission for

Ritu Baral

Got it.

a you of mentioned progressors? KOLs. And Was interested then, there the few of over that mention was FDA the fast different We've Okay. populations. subpopulation from that any lot potential years a heard encompasses in a

Michelle Berrey

will have don't have at be with certainly those We'll the will following data. of top that. line be looking multiple we that our line that but that anticipate I data, top we availability assessed populations

Ritu Baral

then, more ELF include fibrosis -- have and endpoint other And ELF are into to it. quantification? the primary endpoints just other of to biomarker-based analysis, or companies Got AI something and of analysis? either plans that. endpoint the I just moved the importance guess, on some the the going companies Or, moving maybe, Any their REVERSE to within their AI incorporating promote amend assessments. to Any to various back

Michelle Berrey

apologies, And in They and let to stick to we're question through ask et third queue. So second we get do -- endpoints included at all that analyses. fibers, this the as available that -- to tests, cetera, the have non-invasive the then Ritu. wet be noninvasive of as secondary quarter. one well include everybody Thanks, these will our including be secondary as the will to going biomarkers, the

Operator

Smith Our of SVB. next Thomas from question comes

open. is line Your

Thomas Smith

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

can global the I They into split guess, deal, Advanz the REVERSE that's Advanz your then, any provide, -- the ongoing and could much details financially just comment visibility relative And trials? conducting spend thinking how the on U.S. to operational total? you were also you has REGENERATE reanalysis currently the on Just additional on diligence. ex of their

Jerome Durso

comment at your further deeper that, it kind really investment as question, that maybe, deep as Thomas, you Andrew, Thanks, territory. done can color want around it I of commercial except they imagine, Was did to much than Thomas. that to get kind there? have trying comment the was on -- what by of understand on we're Obviously, process, question. Appreciate company. the Advanz a you diligence can't

Thomas Smith

operational U.S. Yes. Yes, Correct. ex spend

Andrew Saik

the right? profitability is top segment. for by break can are you can our tell Look, have the margin that profitable, of International So on unit thanks you business business question. But the U.S. very I don't what through segments, that and the commercial P&L, the we see U.S. we U.S. gross our unit, out we the Thomas, on both unit being sized, a by the great the a just terrific Advanz business business. of It's that, This the international growth, come is said virtue is made Having asset. a for and think -- us majority sense of profits terrific our showing and business. getting also strategic Yes, level.

think U.S. fair, the for So of of the very good majority a do business by by transaction keep we Ocaliva being yes, we generated larger. the both sides. nature it's And the profits just

Thomas Smith

you Appreciate taking Yes, Great. question. that's helpful. Okay. the

Operator

Instructions] next Mayank question B. of Our comes from Mamtani [Operator Riley.

is line open. Your

Mayank Mamtani

for questions. on the Congrats Advanz Thanks taking deal. the you. Thank

a maybe, then, question and also. just So do question have PBC I quick on a clarification

to NASH, rate done that that whether and that just tracking least of how you PBC then, previously can your the issued, data initial X the has So analysis projection? a years there you be some an relative the your don't been I you has with to has on changed any the U.S. anything there relative that time know, patients, now but assumptions the component lastly, of event just guidance you're initiated, underlying there? at would study you HERO clarify out issued has manner that for you suspended, -- the And blinded even just submission? timeline then, in changed? part you're on guidance, is that last And informs have

Jerome Durso

right. All

So guidance question an with maybe, guidance and come pending and back later suspended we sales, we with the update. have around an -- start the which ability closing to

Andrew Saik

impact timing the fundamentally We're in place. issued very quarter, are U.S. just we first the in happy changed. control. guidance, we fundamentally we the just we sales regard on business that not in had largely Yes, earlier both guidance and under We're with the due of But taken We're likely internationally. that to the transaction no, We're would to in transaction, makes reissue sure. where year. reiterated. have can't has with comfortable the has the were to think fact very track. suspending the With changed nothing nothing the it very Advanz And Expenses sense QX. and in

Jerome Durso

So maybe, HEROES? on

Michelle Berrey

Yes.

at and survival. we from you'll shows highly the the improved study database Liver statistically compared significant of large with presented external pilot Ocaliva So transplant-free Meeting extension last voice impact the year, the improved open recall label on and

turning from are full from the PBC databases to data that We Ocaliva to of data two and XX,XXX we of study. the larger patient our in external now years to COBALT over know support data

day will continue analyses supporting will database EMA, and that's databases, the transplant-free submitting X FDA we also primary the last from both be COBALT data registry to we and hope We the be will claims but X in these to as year. those show patient with that X large this a survival we showed

Operator

Thank you.

Securities. comes of John from Wolliben JMP question next Our

open. is line Your

Jonathan Wolliben

from X Thanks focus the for and biopsies their mirrors, FDA. reread clarification to updates confusing methodology from the just feedback using new new the you to package? they When the just your you Is primary data interim use the are patients wanting Michele, hoping from analysis clarify, I wanted to word just with today. for primarily that readers? question taking the the for the XXX

Michelle Berrey

Yes. Sir, are that just patients of start of we interim mirrored this importantly, and analysis analysis focus rereading to XXX subjects, resubmission off. Yes, their those primary original the on is all those interim an for but important the -- FDA a to central very as using really we've been It's almost for methodology, large by learn for about, central readers. database. new now. read were This year talking this the that from is two

mirrored this will what But who has referring every biopsy in been data So and a of liver willing the was second certainly, I with be those we're patient the to interim of us set. again, excited them to for both with providing database, to data. be included eventual primary provide analysis the analysis analysis. the the But data that's same with interim set, this analysis full in

Operator

comes next Markets. of Abrahams question Our RBC Brian Capital from

open. is line Your

Brian Abrahams

out congratulations Hey questions. my for taking Thanks deal. guys. on Good And the licensing morning.

REGENERATE, on another I just maybe, So Michelle. guess, along lines you, the for kind of question

able think that So that wider the delta won't the now, you to effect will including be broaden interim endpoint? or you'll you to is that on believe showed have, endpoint do won't that methodology database, show reliable with in XXX overall in histology be the primary additional given you'll the database the helped coupled more be with the what you need to -- those comparable just biopsies sufficient? have larger you long-term a safety Or that do primary you a may

Michelle Berrey

guidance That's in a stated the consensus again, had they methodology. wanted which a that great issued, question. been recently And look the guidance draft remember, -- FDA to the at

they at sure So same population looking the make to patient analyzed that central was previously using readers. they're that want

So that apples-to-apples set if their data comparison readers. an see they have prior between two concerns that addresses with same discordance to of

will patient sure every at these to liver that included full wanted data they they one the be they're patient population. going the However, will it first to the for analysis, a undergoes analyses, single in make was any ethically, and patient set, who certainly, looking in mirroring But analyses. see transplant to want original be of included

Operator

comes next question from Our Jefferies. Michael Yee of

open. is line Your

Michael Yee

appreciate the good questions. Hi, I thanks morning.

they in of how concept all given all maybe, and a that? that? asset, if about would to which that, cirrhosis you part value about the is outside And talk Our that, the quarter second go right getting of the drug literally, and decide want could whether little of is positive they from So MAA as thing, rights question someone relates to how personally, study, all have their this or the of some file was they quarter NDA States, that? deal reverse timing or not the it And fully thought up? yours, wouldn't timing maybe, including our front United insight re-read want in of relates than bit you the into OUS is same the if ahead of do the next not? that the question to transaction, just And the Thank literally they -- OUS just you. of REGENERATE control

Jerome Durso

look as we be in a about and will Intercept on the been as we potential as Mike. as this talked getting for as that as period next we is Thanks, the as at we've the questions. steps strong Appreciate consider possible. looked that basis, we're focused foundation transformational optionality And we much can. strategic We've financial the ensuring and at in as

in allow time. we with value make have to right optionality, think ability here, we whichever sheet a company we balance scenarios, the on, I And choices. when the frankly, and forward creating all and strong the at path right to the the felt level that think so to ahead us, ensure this comfortable I we're And invest of will of financial kind move of our strengthening think

the advances, ability will thinking, the file. or will interactor decision-making on whether the have own. in optionality deal, be they to to So gain, again, the speculate that regulatory good they we the on deal. the a based the I again, it pursue. And the we difficult decide they felt And strength according to me interest whichever rights of was think best do to for in not to territories It's they

be would how it their our continues the we it as So We global data access generate give the be and history discussion the regulatory their the on of call. U.S. and in would them developer, that to again, the would, but that side, decision.

Operator

from of Jay question comes next Our Oppenheimer. Olson

Your line open. is

Jay Olson

Congrats you process about process Was Ocaliva on for that ex-U.S. my Advanz? the contemplate Or to combo? competitive business And that Advanz. you. And U.S? to include thank taking bezafibrate And the you with deal also you question. multiple that ex the rights retain selling the the bidders? business? talk Thank does a U.S. those with process Can selling do OCA Ocaliva deal the does rights for

Jerome Durso

rights a and process. question. part -- reminder, to rights pursue mentioned specific I with in So succeed earlier, and and sales with Advanz PBC. The to was And is if as pursue your process. another bezafibrate NASH, they royalty, the plan. the development bezafibrate from multiple our U.S.-specific there. plan is OCA Ocaliva Was were a obviously, to there if they $X agreement there they parties our have for The Yes, that there involved well, to the as monotherapy

Operator

Our Baird. comes Skorney with next Brian question from

open. Your is line

Brian Skorney

My of of this allow bear. This you get it seems OCA your good to running to but Hey, substantial REGENERATE much commitment like FDA reanalysis. cost the a just question if kind as level cash of on to XXXX morning fully deal a review is, The this designed. too based doesn't on everyone. position, really, is what gives might later out completing or

why study XX-week move option and reanalysis the stop safety. patient trends now X,XXX you X,XXX most and I see So in what and If to biopsies, just the of this X-year of would isn't not biopsies many events, between events years X,XXX And guess, forward? have do what is that How sufficient, have? this you accrued point? any likely at

Jerome Durso

start and continue. that color the on Michelle that, some on I add can Maybe, Yes. work we'll

here. in right that is approval we So set an data the with but reasons process continue if on able interactions outcomes that accumulate so I important subsequent of pathway, just pathway. that in have eventually? approval focused the of one on interactions path succeed why sets so accelerated define that exclusively next earlier the are we data we've generating the we and that as we need potential financially, to with focus That's choose Obviously, been do color data we'll agency optionality make for and OCA pathway, we said where us, to piece accelerated the to strategic is. mentioned, possible accelerated obviously, good any the the the that as as our the strong was that regardless on bit will exclusively the a steps, sure on it's foundation, and on we Michelle, of which are we're the the data are NASH the the focused of

Michelle Berrey

tests I'd surrogate thing both noninvasive be would only the that both considered are add histology Jerry, the on endpoint against The clinical need validated the And of that, markers. is potential to those and outcomes.

So without outcomes, date. been validated clinical neither to have

continues said, secondary month analysis I histology non-invasive interest So looking of submitted. potential surrogate of will at XX focused the have to as with and the package on in the analysis those But be do that part clinical to much interim this is that Jerry correlation those tests be believe outcomes. agency certainly, all

Operator

Thank you.

question next James. of comes Raymond from Our Seedhouse Steve

is Your line open.

Steve Seedhouse

that be you. X fact, terms you in expected penetration. I it's Good confident of unclear in have your you much guess, peaked comments, not, In morning, how going thank in from sounded PBC U.S. should Slide growth forward. prepared

about you wanted of COBALT you volume volume to terms U.S. year-over-year. growth, that's was positive? I PBC Thanks. data, ask post What specifically the expect And achieve So what can and in assuming that growth do this quarter? in

Michelle Berrey

a we ability. need we come we're think where label lost our confident I X% a X% that of change. through to Remember, So based to very period business in our on

allow the the in resubmission we've full great highly as have for So we'll that our and we're coming approval look or at, data fundamental differentiated of with the publications we with to beta a U.S. be starts said comments, will to that. in us replenishing patient unmatched to And the that moving be time and others, vis-a-vis market help in we that of new that offering part that forward, been will I are amount opening value pipeline stead. believe in very going

we underlying frankly, is X, could plan twice those if are of and only -- up volume. growing units, kind patients from our taking going X scripts Focus back that's So are for smaller who even And weeks, that's get week to for business. units be that look the X plan. at because low are we though a long-term a were those

in have regimens, and volume. capacity, we're forward we're Now the on that higher XX-day that we actually moving

Jerome Durso

about other Ocaliva, only I'd only reminder potential of candidates label, additional we the for make according have treatment. the that to been point just estimate is one-third on The a

significant for are label So there the for, still second-line and Ocaliva who within the a as indicated option who qualify would is who of treatment pool patients be only patients.

on the ahead U.S. So in we'll Ocaliva continue the good work

Michelle Berrey

seeing -- in before, prescribers coming to continuing expansion We're as their see are gastros. are community physicians. we to Patients strategy our new seeing with back continuing new visits and And we're of said again. up, market, to we're and

us think path forward. I does kind prescribers, new data new visits and So this of give of really patient positive combination a

Operator

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

Your is open. line

Joseph Stringer

Thanks Hi, our for good taking question. morning.

other indications mechanism to FXR consider follow-on. NASH Just explore action a that? an on of agonist for quick of you look just you given Thank one as the XXX, indication? types would Or Would you.

Michelle Berrey

XXX, pursuing we it about and year. potential forward Great out to from look Happy and of this rolling we forward the this to now more about that differentiates I'm later have how preclinical question. that molecule. and OCA sharing look all data are it on very this talk indications excited about we the to molecule,

exciting look forward really So Again, that. all a sharing we molecule. to of

are forward on we think continuing I to NASH. push

the we a optionality. questions, exciting OCA, forward molecule think at look a and I give to our I commitment that lot differentiate does there think looking certainly, with can't talking later year. this about of on that us are but that gives We

Operator

UBS. Our next Ellie question of from comes Merle

Your line is open.

Eliana Merle

Thanks question. the taking for

the a And any updates? I longer-term would they it included, longer-term be as if would say, Just liver what perspective, safety maybe, data? Thanks. to in the more of outcome as cirrhosis guess, events particularly potential in we'll terms a from provide of be brings to data, updated sort progress safety such safety color event you could getting, I potential some NASH, progression ahead of

Jerome Durso

Michelle? question, the Ellie. for Thanks

Michelle Berrey

Yes.

with well. able include happy we safety, as are we adjudications the will So all the will on that to top giving, be line, we there be

much not did renal this that events, with larger, cardiovascular but and robust an committee incidence risk given X have recall clinical for population at cases patient that diabetes, type safety, is we specifically increased them safety higher looking outcomes the may analysis cetera, there. safety a for adjudicated et this you So of safety puts database, this independent at more hepatic at

and the to cardiovascular are all kidney So make safety sure fully adjudicated. we need hepatic that

Certainly, represent will those all top adjudicated the that share half, conference. month outcomes The Those over the progression two-thirds that cases will So this. with to data. line also will should of will scientific ever the cirrhosis. we be along and be to the even include are final maybe, a events later at part details for being of histopathology, which XX analysis planning those of hepatic

Operator

Our next question Salveen from comes of Sachs. Richter Goldman

Your line open. is

Unidentified Analyst

Are million $XXX for the in special the or will if model But either. we anything there's to I flat Matt then, roughly wondered no much. these And -- then, milestone you just said assuming be for or Thanks as just the of there's attached to these next in anything Will this terms transaction. very the questions. digits. royalties, This you Thank if Salveen. you tiered? taking we should that double consider? month And I'm see there's we consider should is on X, are else recorded payments said? want

Andrew Saik

the fees cash Yes, on upon upfront, sure. of be working that's payment $XXX that. capital take That as a it's and going described, Yes, other million through transaction. the come to as to immediately the Happy to months, regulatory. is, will We're the by we the in inventory of X but upon that in June, which, X we be get end can't to process. hoping expect you depending control to close, said, next net

for In really, terms million the new is to of the just The million the royalty, related upfront business. $XX Ocaliva royalty territories outside any subsequent is indications in U.S. and the PBC $XXX

sort as of So is get a strong not the U.S. Jerry That that It they essentially ex that indication would only kick the tiered. in, down event in royalty, It's to any double-digit NASH in a goes of mentioned, $X. territories. royalty.

NASH. stays starts flat Is the and at sales that for throughout helpful? sales X it So process

Operator

comes of of Meacham Bank Our from Jeff question America. next

Your line is open.

Unidentified Analyst

This Jason for you our on is taking much Jeff. for Thank so question. morning. Good

especially the along how of have the safety biopsy kind lines, part is Let to that being or how obviously, Appreciating of my me on additional extend sense be, return these congratulations data the a focus critical outlying well. much focus a could outcomes? resubmission REVERSE on a guess, resubmission. efficacy least you the will see at deal Do also NASH. as you the potentially I of given Thanks. primary package? of wanted to I

Michelle Berrey

Jason, thanks the question. for

on risk will certainly, robust. benefit database there. now role more play a is the CRL was much So key previously Safety and focused the

have advanced safety fibrosis, prior for patients showing in to top presenting with hepatic sure, calls, mentioned safety our of line is to likely renal parameters. the long-term I've have life those after cardiovascular it's that think for And those and with therapy used -- when compound progressed I data. data to As be that important especially be we'll initiation

want analyses new do the the XXX, the consensus new as but the patient population I've FDA a the that side, versus with an comparison this panel have methodology. On reader the methodology, with central been with we efficacy of clear new has before, they prior increased mentioned

have those include of of total as subjects well, that with yes, data I regard the will because will be be have we for With first first do analysis. the weight to additional clearly, expect the setting FDA this to in the Phase especially and that the be interest in the will in compensated an that, would set we cirrhosis. that REVERSE, readout that advanced patients all So large be critical, their expressed any study want evidence III in But molecule.

of So I great think interest process. that their disease more be advanced really us, of that, all to certainly, to where in will beginning to see patients get these are who are

and conversations content agency the of as So we'll I looking the about, earlier, potential have the structure the Thanks mentioned for question. those the to be resubmission. with

Operator

question comes from next Cowen. of Baral Ritu Our

is line open. Your

Ritu Baral

to end for inclusion the follow-up. of did Michele, that we're that just That sorry, the resubmission. Phase that saying no, about any Hi were if time. you're going Thanks was earlier thinking events taking on I guys. REVERSE AI second think to ask on you you for did was want or I point. include about have poised, how IV when -- you my follow-up question,

Michelle Berrey

setting, Yes, points. looking we in -- Thanks on your some and at are so Yes. secondary patience for Ritu, end Yes. those, the exploratory NASH

that particularly the a to is that helpful But of had, Looking funny, AI sort now. are as assist can FDA increasing of in can and human areas, the AI to human there interpretation of certainly seen certainly be of interest that had in we therapeutic interest, assessments. specify histopathology some pathologists in variability way how outcomes addressing reads where either at We've those a other concerns AI, those there with about helpful. in be are in growing and have human those sort

that a been So and with we've we AI including that companies different of working front. are and REGENERATE on both REVERSE, in couple

the new placebo-controlled about to I patients they to what some study remain look study. is progressive the Because your earlier primary and difficult frankly, to think -- at It's recognized or own not and other stay events. disease, expanded regulators to when a ask arm placebo probably question them I difficult their a ask see it active a think COBALT of the how they of on on have and all can, placebo was they're is long-term whether or drug. the endpoint biochemistries includes a blinded that on have

have they believe, So these to phase the a hospitalization expand the that endpoint we to at clinical or benefit regulators we the detecting to increases Ocaliva liver able that for to sensitivity are broader have liver patients primary transplant, composite events for been grateful with an that progress before work in death. of earlier we

Operator

no further showing like call for to back Durso turn any closing questions, Thank you. Ladies gentlemen, I'd Jerry and remarks. the over to

Jerome Durso

all the Take the us I today. Thanks, forward not certainly we'll is extremely we important sharing as out definitely Intercept Last that with we and puts time ahead know recent in a for least, thanks, future. we the this has weekend, mothers to work there. best addition closing, everyone, and soon. definitely and things joining head more work to In specifically then, what quarter, for talk So all position us Pharma, believe Intercept build the progress. the the updates strong I into look my first that care. as agreement accomplished the work as for team in to in since Advanz an the to manage

Operator

this conclude day. gentlemen, does a and and conference. have today's you Ladies great you. participating, for Thank all Thank

You may disconnect. now

Intercept Pharmaceuticals (ICPT) 6 May 222022 Q1 Earnings call transcript