ICPT - Earnings call transcript Q1 2018 | Intercept Pharmaceuticals, Inc.

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Operator

Thank you for joining the Intercept Pharmaceuticals First Quarter 2018 Financial Results Conference Call. All participants are now in a listen-only mode.

Following opening remarks, Intercept's management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request and a webcast of this call will be archived on the company's website for two weeks from today's date. I would now like to introduce Dr. Director Development Executive Investor Intercept's Vignola, of and Corporate Relations. Mark ahead. go Please

Mark Vignola

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

financial future market we prospects, undertake objectives of only and as reliance expected of trials, strategy, of revenue, this and treatment approved Before undue our which commercial of the place than approval speak in of forward-looking of and on develop, management certain are statements, to call costs, NASH, position, the like no statements the future future potential date safety regarding our discussion, not statements, forward-looking these Listeners candidates plans, our growth. obligation inherently projected other to statements based to a of estimates success to required assumptions except our results that and during statement including making of operations, and although product, we and efficacy will our question-and-answer and for product that, our clinical number be uncertain are uncertainties. are PBC, timing and indications by risks management subject be on and of trials begin These progress, may law. other potential OCALIVA, reasonable, our timing OCA update the and the call session I'd we believed OCA the note today, any clinical by forward-looking we forward-looking including as to cautioned and

and or press our discussed XX, Commission Form materially forward-looking XXXX. our including the annual the from XX-K on could in predicted by are for Securities differ our actual our Exchange ended periodic the to necessarily this those not Some, or year all, cause of that U.S. with December and morning's anticipated but our report filings release historical results statements results factors

call or been not other the that than this regulatory PBC. conclusions by at is safety drawn approved note Today's from U.S. Financial indication No any then Strategic Commercial an that to in Lisa our cholangitis has In of Chief followed investigational President, open authority OCA addition, be President, Mark in biliary OCA We'll remarks indications Pruzanski, for Marketing, will questions. from time. can begin please other product efficacy any Bright; use or those and our our call primary concerning Richard Dr. Kapadia. and by Officer, CEO, Kim; with the take your International, Sandip our

to our Let me now Pruzanski. Mark CEO, the call over Dr. turn

Mark Pruzanski

U.S., U.S., reinforcing Israel. OCALIVA to across the label the in We OCALIVA for Canada approved launch update which completed Europe, appropriate the of today cirrhosis. in OCA C safety include and cirrhosis. NASH with patients Class and the compensated We evaluating everyone, us company. thank had $XX.X this Today, the great for have OCALIVA you in XXXX today's several year reported in goals the morning, Good are we first worldwide on Highlights set against Mark. good QX We the call. of deal we And or or B trial, our efficacy during joining decompensated making patients REVERSE X critical of Thanks, quarter. the announced and we progress accomplished following. quarter drive include first the sales and net and in markets, the dosing for PBC Child-Pugh with achievements a million continued Phase we our

strong are to shareholders, important were members of ongoing capital showing coming and at raise. in raised than and those the more $XXX $XXX.X after EASL contributed support quarter, this program to proceeds gross abstracts several public Additionally, stock our of million development We're a working our myself private concurrent company, and and of concluding of included, just investment we million just get our pleased several common we successfully a presented. where last after commercialization of together month Paris board requirements. in including the the other to Last, offering OCA the placement large support to close meeting who you really

are growing key As look in focus to NASH. there will priorities franchise we position ahead, PBC reinforcing this on our leadership continue two we our and year:

our Now effort. some PBC more detail on commercial

or As patients you a These in in decompensated OCALIVA, label announced advanced overall are with at a patients February, the or know, and more of very we X% Child-Pugh believe dosing to X% stage U.S. EU, of represent population. approximately PBC in an Class recently, appropriate we liver PBC and the label for reinforcing B updated harmonized C their disease cirrhosis.

Of course, we And net OCALIVA Consistent on physicians this, more to guidance $XXX have opportunity our extensive the will in the growth. PBC to today, we we of are Lisa updates community treatment OCALIVA population international in address the with for patient to refocusing confident the and been now and Richard XXXX, for need label. shortly. educate be U.S. and will eligible to sales efforts to businesses return continue and million are are unmet on $XXX the million in providing detailed to pleased the provide and and updated

in cirrhosis. Moving trial announced now advanced to comprehensive work our program with Phase and includes the REVERSE with trial our recently fibrosis compensated REGENERATE in in patients NASH X NASH, patients the

FDA the population designated know, this fibrosis shown efficacy in trial. have flagship it Breakthrough on and OCA only features you NASH key based Therapy in currently a endpoints, approvable all histologic REGENERATE thus As therapy investigational NASH underpin to that two improvement. resolution far being is namely, our the fibrosis

line initial interim for an of on a follow-up clinical on on outcomes interim to continued top benefit designed confirmation the remain post-marketing As in of basis. We track readout XXXX. for regulatory the a half reminder, REGENERATE analysis supporting the on data from first is with approvals, of readout analysis

designed the to most disease expanded in cholestasis Our data the is study of trial evaluate X development of liver and NASH in reverse XXX NASH failure We would of our population to cirrhosis and to the We biopsy-confirmed as on strong with confidence Phase NASH our reduction X reversal broader expectation focus compensated With is and REVERSE development. to earlier mortality. cirrhosis in on designed we focused NASH. over and note risk results on the the associated a for REVERSE patients where efficacy based we've efficacy REGENERATE of REVERSE, which enrolling of safety OCA significant trial serve course. access approvals the is Phase potential very of regulatory to worldwide OCA's the leading with of and an on basis diagnosis stage all-cause market in due remain positive with in the cirrhosis fibrosis safety The any compensated with have of foundation that program. therapy investigational a quick robust supportive broader be A program, launch. now patient

we path As disease the forward cholestatic a in PSC, to or no reported March, with liver primary define engaging sclerosing devastating cholangitis, approved we're FDA this in with year autoimmune therapy.

we regulatory this of to on As an and we path time and some our plans expect appropriate the process NASH with later take PBC it, will year. defining before update you

OCA's associated a is a one or treatment Phase years substudy patients least in Study XX Association EASL. we were the reversal further advance treatment anti-fibrotic majority of clinical benefit histologic in predict very relevance failure or with to the absent patients liver or results an and showed trial, Notably, trial. late-breaker POISE of is important the PBC biopsy-based NASH clinical Annual present data tolerability with OCA, FLINT baseline, of supportive chronic on a on the the with long-term of improvements biochemical high-risk liver from the supports encouraging are stage the and all previously-reported PBC demonstrated liver open long-term The of benefit in three administration. came Meeting successful potentially This to a Finally, We cirrhosis. four patients disease treatment improved of patients it the treated of Liver, the A the segment After safety reversal label fibrosis of because in need the X XX of PBC OCA fibrosis at three data sustained in and by progression for XX, are for cirrhosis. demonstrated response pleased the ongoing population finding phase to improved given predicted with European of with suggesting maintained stabilization transplant, stage. the recently abstract the and, fibrosis at death. the outcomes in off also POISE of extension for to months impact the patients, durability a cirrhosis that second and without of and OCA's These that of trial.

underpinning of EASL with safety the in robustness based disease. out including the our our NASH in setting beneficial fibrosis PBC important real-world reminded data cirrhosis, position the of TARGET-PBC patients progressive receiving abstracts came therapy OCALIVA with clinical as that program. consistent the the our of of the the demonstrated confirmation on first strength meeting, competitive one OCA our in Finally, had in leader with We non-viral in of liver of at patients effect of other presented and development the post-marketing data and

of with everything limited indications. saying to PBC drive the Our defining X to clinical our treatment program benefit. conclude remain medical a and do that, to at commercial we we path exciting Richard on our affairs to Intercept, I'll for forward center U.S. look options in are of Phase With continuing by data. team focused continue update. is innovate it other our new growth broader that work PSC the and patients driving now turn and focused scientific on at very I'll for their we and franchise and communications forward over NASH Liver in

Richard Kim

fourth million year. down reflecting start across OCALIVA everyone. prescriptions quarter XXXX, the good and industry flat first gross-to-net Mark, morning, from we the see U.S. QX to Thanks, relatively and the $XX.X as sales a net for higher the in in a reported quarter, We

The key driven update of first in the by for quarter FDA's was label OCALIVA us, the transitional February. one a

engaged a rebuilding decompensated step itself physicians C and clarity stakeholders. with cirrhosis in been September, in While has our team B regarding marked updated dosing or of our Class OCALIVA the correctly confidence label with PBC or patients with Child-Pugh the in crucial importance

to the UDCA. start in prior we are can with afterwards. in As year, out sales an softness medical bring inadequate update that our the to OCALIVA excited time both PBC moved response patients We period a what to we the of now first unmet see have to and need quarter, the label and who our can of focus on for or did intolerant conversations are

to as a However, to lift quarter are TRxs starting the and TRxs, beginning stabilization build. in also and general we recently, some we're initiations see new IMS patient most progressed, observed in our

time slope knowledge we generally to realize, our based PBC year, last trends see had we our every know to like months some we'd market, will While that approximately on this six physicians prescription the (XX:XX:XX) patients or to their given return more. take see the of

For and PBC at to XX Based non-prescribers, about prescribers on to the half belief foundation strong. of we're solid a they year, treaters, safety Pulse the OCALIVA a very we in said have the we six phase, label with PBC updates, believe focused both April new that moving within on a communications intend OCALIVA fundamental remains move end and patients because prescribe forward to research OCALIVA conducted to XX% now our next their months. and and

in prescribe physicians OCALIVA. In have to they five four right believe addition, over that information the

the encouraging While positive, who patients. key for are our the sales there information to us and that and responsibility This that some see for consistent belief inherent before that additional of PBC are reflects from prescribing, These their a that physicians address. value physicians is team. with still OCALIVA we data received our the research feedback indicates need

for coverage. changes is Now, fundamental important stage to increase our to physician it implemented have sales belief set this we model the that

We and have to sales expanded business contract the territory representatives sales augment or our number added a efforts. of team managers

our and we expedite the will With have quarter more it now to changes. the about significant time but as actively used effectively the physicians, a we physicians deployment are have complete does who sales completed change coverage to XX%, All of training some increased reach for and customer impact, said, was selling patients. contract teams by we are this this to model, us transitional our time take of our and on evolution, allow seeing first our which team. and PBC a see That our calling

have now complement full in of materials programs the field. we review, FDA and promotional Following our

have has executed refined have support Lisa. never this And To like PBC with There enhancements both our that us physicians to further now, turn messaging people call treat over patients who living for many the disease believe We will Thank stronger. attention. benefit brand conclude, long-term are communications. from for we been important and OCALIVA, growth. to still believe position and that your our quarter, to we and supporting to many commitment I'd eligible we them the you

Lisa Bright

With us with over we're our year Thanks, in Richard, Canada, international morning. encouraged and approval behind a EU launches. and good since the regulatory

year making Following net beginning and across majority most meaningful OCALIVA sales rapid be this the of the coverage are impact to both however, France, see QX In and reimbursement and the of to we're earlier million. and US$X.X launches. private Germany contributions. The pricing in including in Spain Canada, U.K. were now also international sales of continued Europe, Canada sequential

continue Healthcare with in to with providing few the Europe commercial Letter last focused now and in pharmacists were the In provided updated last physicians the reassurance this appropriate of our been EU the and months mailed available through teams. and Provider an on website. clarity. will XX,XXX impairment In this the the and and of EMA, important medical outreach step parallel, Dear with Commission further on in label communicate we to good SmPC. and February have Over we over All importance be discussions reinforcing year, the line dosing year, in to proactively together, appears we has following to EU this, confidence patients is hepatic

optimistic more like international growth details. a year, So we're and few whilst early I'd our about to it's days, this provide

we that since growth months. the new to Consequently, EU reinforces market the but a the in good In impact first prescribers for reflecting not breadth increase Our in prescribing fact, increase we've also And launches, what year of seen are getting more physicians our only market prescribing. hear in country an December, patient the the significant suggests amongst quarter. XX% intend of new in of to those prescribers new we their results in we centers. This to and yet, other prescribed November haven't six research have of prescribers XX% January the current anecdotally next OCALIVA seen patients. most over OCALIVA current our identify outside who to six from in months, and intended continue recent target that next prescribers this year last across start prescribing conducted prescribe also main research important Canada,

the Finally, expect are current to the insurance. in summer of therefore reimbursement those who Canada, coverage gain XX% by and in covered public we patient private expand beyond

market executing a our and the I'd commercial job this like Sandip. launches, that, on our a So, access our to and to in should doing call international summary, make ongoing year. contribution our And teams for region are great turn over meaningful to with global growth

Sandip S. Kapadia

OCALIVA Thank Please for earlier XXXX. results, XX, you, financial take an issued for $XX.X sales press a recognized and $XX revenues our XXXX. morning, ex-U.S. million of quarter position million the We've to of update opportunity of million. including for everyone. refer on quarter Lisa, of of the results you like net release XXXX, sales comprised $XX.X of our guidance financial and summary U.S. and million March ended sales I'd XXXX first sales. the to net net QX give net to good our $X.X in today total cash provide in our OCALIVA

from you a good Lisa, transitional can future with the Richard a As and was heard label serve quarter growth. as update basis QX for and

to related range. and total XX% first gross-to-net were gap, primarily quarter on for As based our communicated expected, deductions impact the D deductions coverage annual of towards of previously end to increased quarter Part Medicare the deductibles of the the in XX% gross-to-net higher we resetting gross-to-net

stock-based non-GAAP the Our our operating quarter compensation $XXX.X for $XX.X million which depreciation, million. operating and GAAP were were total excludes expense adjusted expense, and

were $X.X million. of sales cost for quarter Our the

the related to expensed of prior OCALIVA, costs discussed, to manufacturing approval previously commercial OCALIVA the FDA launch supplies. of buildup we and As

OCALIVA a our remain As until result, negligible sold. we sales the expect cost of previously to of supplies expensed are

We of also convertible for to million our $X.X interest quarter related recognized the outstanding notes. expense

and and quarter million private equivalents of million, guidance, to expenses our announcing we $XXX.X April cash, had we of and million. XXXX and common and million. Subsequent of public deducting guidance of to on of our for March a after the received our in end our of XX, outlook net from offering completed on our offering net placement finally, the commissions proceeds $XX.X $XXX.X transitional estimated as Moving XXXX, results stock. the moving offering million. the we're remainder approximately approximately between $XXX on cash available financial concurrent to underwriting securities We investable based year, of cash of sale And quarter, $XXX position, discounts, first XXXX OCALIVA range for the XXXX, sales

the for XX% year gross-to-net be XX% to expect to to in continue We range.

confirming we expense operating guidance adjusted million $XXX XXXX addition, million. non-GAAP announced to range are In between our $XXX previously

For expense approximately component interest notes. includes interest expect the cash outstanding $XX of full million, year, amortization the of we and both convertible our which

as to Finally, regulations. SEC our of Please reminder, over operating non-GAAP operator press release adjusted turn With it and like I'd reconciliation a non-GAAP measure. this under that, an Operator? a refer is the to explanation morning for questions. expense to financial for measure

Operator

Certainly.

question first of RBC Abrahams Markets. Capital Brian line comes Our the from from

Your please? question,

Brian Abrahams

for guys. taking little the drill Hey, an scripts financial very in in and your below of guess for or Thanks second modest assume end and the guidance. the more some questions. my sort wanted still year was much low one throughout to growth guidance. to seasonality, question would adjustment beyond If of a for gross-to-net I the on of it quarter bring down sort we first bit my I

with we might that when you And we pull-through was bit from pickup next scripts elements U.S. wondering about that to a see effects about see start quarter, any the Were maybe in like the that thinking revert things the be I So approach? I see might in underpinning more should and the do we Canadian greater that. Thanks. we selling expect reimbursement? how start the European talk contribution new if you little inventory to might in could there guess

Mark Pruzanski

and Thanks, to Brian. hand Sandip I'll then over start to ask Richard.

Sandip S. Kapadia

Thanks. Brian. Thanks,

guidance. I of Richard U.S., a good getting us. We're I been to U.S. in the label. We've I increasing what in encouraging continue future we is, opportunity. the you We we We're I where as think maybe what and we're on continue we want make customers as provided. a we bit and you calls resourcing, good field updated as the believe in sure say the to better we force. terms about is long-term in little will can to trends think giving for QX's on look, – the we've mean, felt the feel point, This provide Richard I feedback of would first update comment and guidance. mentioned, mean, a mentioned, Richard, this quarter in U.S. And time transitional just, get from had general information At bit. good the on seeing

Richard Kim

for use higher had see And more some believe important QX But the really stable as we in as sort Brian, significant market for said, obviously, we launch. Sandip. do time. event Sure, you started and affect very some have Yeah. and really And baseline did of we And a a than quite Sandip can to growth. in our went we was we QX new trends, that our seen for obviously, us. foundation probably seen through transitional our quarter baseline as IMS

exactly the take well. it's our patients of But predict high with kind out very in fundamental we all physicians confident said, is impact. there the really to actually remain long the OCALIVA, as belief we that efforts as the our will hard how are product, and So of

Brian Abrahams

that win a question. saw benefits data what can Can then other receptivity follow-up kind NASH, read-throughs you and in you about of that, as degree about we And But a very in fibrosis That's the leverage talk which the then, OCALIVA? that fully such different really interpret And overlaps basis data should the at studies? and not physician that Obviously, think are of bit there to yet Got additional pathophysiology can the really diseases? that how POISE prescribers it. we little just we from compelling potential obviously, meeting, you at the mechanistic one Thanks. maybe confirmation see helpful. reported to EASL. who may POISE key the to might of REGENERATE a data maybe recognized you over NASH

Mark Pruzanski

I'll Brian, Yeah, take that.

mentioned that are of in majority relatively number a actually population know, history of to patients, physician a very but, reversal obtain the fibrosis. the show to standard group of in patients be And as the of We're or Granted, it's their the is repeat on who to prepared it's very, expected continue biopsy to to failure. you undergo a who remarks, data of So natural you to I see that is care been this feedback my therefore got has small data, population. as and of did that not biopsy gratified least It's liver data. really already did based and difficult at this large biopsy published histologically history patients in positive. ultimately high-risk cirrhosis PBC stabilization remember segment progress natural would to

community, publishing to and is affairs very view I the as a appropriately is So, I also, data our it. physician think, with the mentioned to moving medical disseminate team encouraged

course, then, of enough us liver card what And I FLINT and directly observation that a to again, believed learn soon have therefore, the half saw we've disease. in of fundamentally data. time antifibrotic, when we read-through, optimal the of evidence an the it REGENERATE after, in XXXX in gives second FLINT. OCA irrespective of the effect of hope to etiology. first is, the disease This encouragement, we that second lot again, I an a of over spectrum confirm the turn fact, your We'll in antifibrotic receptor that shown we think is mean, terms target question part across is FXR of

our So, overall, perspective. from encouraging data very

Brian Abrahams

Thanks so much.

Operator

you. Thank

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

Your question, please?

Jay Olson

SNDA support say in filing REVERSE you Hey, guys. your Thanks you prepared to Did the your for for that questions. trial would the use taking NASH? remarks

Mark Pruzanski

was assuming the positive, that they're trial in market anticipate, access results and also said regulatory the should broader that support population NASH of approvals. we we cirrhotic What

Jay Olson

Okay.

the mean before REVERSE So that need results does of that you you can...

Mark Pruzanski

at at No, all. not all. Not

that assuming first REGENERATE intention Our is file to approval. half year, results our for are next REGENERATE – intention positive on

Jay Olson

that. Okay. Thanks on for the clarification

Mark Pruzanski

Yeah.

Jay Olson

PBC follow-up to to data. Do PBC? just that plan that fibrosis once in try the would EASL, published script data and And that be then into you driver you you the label a a get presented on on data that in at it's expect to growth of congrats OCALIVA

Mark Pruzanski

I'll mean, let anticipate answer well, I'll the – at that. No, would actually, necessarily I this current time, the we into label. that wouldn't get

you intend we do as However, to publish mentioned, it.

Jay Olson

for Okay. question. right. Great. Thanks All the taking

Operator

Thank you.

Our the next & of from from line comes Carr question Alan Needham Company.

question, Your please?

Alan Carr

estimates thinking that for which get now, or you in where of the U.S., – last that later are warning year? year, taking little of in And which need you is as you reimbursement because have be the outside to great also, think? the arrangements if Thanks U.S., or a demand and to weaker you that? I'm are as your questions. attribute where then One, in it What's you Thanks. is this unmet on prevalence can slowdown wondering you not terms ones Hi. FDA the XXX% clarify you overall countries expect may my PBC

Mark Pruzanski

to ask of take the Alan. the Thanks, Lisa, I'll you part question? first

Lisa Bright

Yeah.

Alan. question, Thanks Mark. Thanks, for Okay. the

still the in countries U.K., regional in we've countries, of those major in about across Germany, national have Italy, in and now So, in we some of of little go a course, through the this pricing reimbursement course, bit we reimbursement. a level before, of the process Spain, at talked

through we would at good a in So, Italy. for pricing we just hospitals, in it the for Italy. good sometimes of about already of to to bit year of back we its the way example and work that patients progress. approval time XX% A takes individual access little be making it but though very the Even have of got to are reimbursement,

such We which Norway, patients the also in about access covered. Canada represents are some market European mentioned today, XX% have Portugal. course, reimbursement in to private the I And of earlier, as we of of have as who countries smaller

the remarks big reimbursement year, the not Canada, in end – And so the us middle us we our it's the get as prepared reimbursement So and we summer pricing to of there. where onwards. end for the those get already will which of in opportunity year coverage to kind talked of obviously towards into in move to opportunity pricing to continue the we the is local course, of countries public the be for about of and expect back year

Mark Pruzanski

Thanks, Lisa. on the Richard, And part. second

Richard Kim

about Yeah. Alan. XXX% is up to way would very event slowdown very the early here. the To say, we And say majority. say to hard vast on think, had the the of I is in communications Hey, launch I but was label, it we think a our significant ramp

sort to move So some time it has from taken forward of that.

the absolutely patient I before. you the believe as have we that However, as confirmation concerned, we the see numbers patient been when think is still hear numbers are there. And about the need, far unmet unmet seeing need of we the that

are think switch the is diffused. the our one (XX:XX:XX) model patients I new to

and come were we of I down not think at evolution. there's where many fundamentals that the most of principle know, one introduced We've the we a sales But fundamental new I back is would patients. dozens As dozens have nothing offices where That's our therapy force that the launches. to space in of for really the for physicians making well. years. physicians to time educated. take see XX communication. over to everything We've now, that are well us continue based and several the months we're It we've going adding happened as has even And next around really forward done more period new scientific sure does over really

absolutely time for take us So long-term opportunities. to will are, but good some where realize we we continue our feel it about to

Alan Carr

much. very Thanks right. All

Operator

you. Thank

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

Your question, please.

Kevin Patel

Patel them NASH And adapting Salveen all, are for on Kevin the thoughts evolving in on are at landscape study? biomarkers? is This What for your your Richter. if you, how Hi.

Mark Pruzanski

question. the for Thanks Yeah.

don't various of to are biomarkers take the we can accepted X more the and place the the in from see validate but other take for gold we place and all data that one said, ongoing with in the NASH various commercial And this other obsolete need I in have the Phase imaging be. ultimately I speculate kinds believe of into you and At of number there's to trials. what population. agreement those We'll are biomarker that to companies just critical to biopsy. regulatory plethora as incorporated have So sufficient of to both gain markers traction stakeholders coming And ultimately – and that biopsy. biopsy data. standpoint no particular, them can standard, of remains wait studies the on serum our point, of of or marker these That biopsy. We know, will want currently a non-invasive

Kevin Patel

you. Thank

Operator

you. Thank

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

please? question, Your

Kelechi Chikere

Hi. question. what that seen REGENERATE action in of at Thank you of I'm And based in for speak EASL the Michael OCA, data you is, the especially confidence the that the Thanks. field on asking data. how sales REVERSE saw date, mechanism is ongoing Kelechi scripts you generally you Yee. some first in QX? trends and is, your has and question This your to competitor you in also on second you could My question IMS studies? taking confident between for to are to try will that My triangulate my to gives regrow of script force

Mark Pruzanski

I'll Richard of the ask first part Sure. question. to take the

Richard Kim

Yeah. Sure.

end hearing, where up four-week to trends is think September. have we caught actually around the of so we has now far your question in our the what and trends since to the As March, I what TRx communication prior average drug safety importantly IMS for as for seen were we're rolling

safety on feel prior So the to to sort like was communication. there, back we're drug trend a there we gap but that of right from

seeing from and physicians consistent has do label next with for six physicians. lot months. prescribe intend to hearing research, We our we've you believe are and provided as the about they confidence very the heard sales said XX% our the provided. we research Pulse clarity that did is more in that what we a force And when Now, of

more reach to hard our predict are ability our on in confident that's So this who exactly we've that is patients. a model will physicians QX, opportunity go build we're PBC growth done managing in to and to the enhance but what

Mark Pruzanski

of well-positioned population, to amount and At backbone have going OCA's on of NASH in very important day, to assuming benefit their to in see to datasets. we agonist and landscape, mechanism intriguing saying mechanism therapy disease some And of in first-in-class only drug, be huge remarks, an more about over and and There's and to namely the confident trial. unmet the was And long been the number that remains different OCA and have the shown to with heterogeneous all have room resolution patients early feel I feel, across the there indication our with datasets two particular for a a disappointing population. and of – approvable trial, it's the have and in a or is the the hard last histopathologic NASH. again FLINT Yeah. competitive that, population course, with it's the time, way in file relatively be the of key year, a going NASH end the your establish NASH the ultimately efficacy drugs data this this FXR gratifying based based recorded next more as in REGENERATE prepared in for subgroups endpoints, a investigational It for that respect time, plus features therapy eventually innovation been actually year of of approval disease improvement, my this the find underlie in There've But data interpret. of as well-controlled on to fibrosis robust for options. mentioned going which And some we've need. out been FLINT this on. Phase X and and been to tremendous currently question to different success, we

Kelechi Chikere

Got it. Thank you.

Operator

you. Thank

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

please? question, Your

Unknown Speaker

after baseline as your changes XX% far NGM of review by as that change This display Trevor what XX-week the initiation for below of Brian. endpoint? in protocol end XX% the does for (XX:XX:XX) see showed thoughts the patients LDL were you therapy REGENERATE LDL REGENERATE Hi. Brown And the that the to monitoring almost the data Can have an increase options to we on investigators intervene? by is study please study? on And through as might managed what

Mark Pruzanski

Yeah.

study. real-world as a designed REGENERATE So, is

statin So and allowed not means dose Investigators world a baseline. in at patients increasing LDL are by are what the monitor the encouraged cholesterol. statin that would they manage or on is statin. so by a that on to real lipids to of be as do can They a adding statin,

So the to question. answer that's design the

lower X an why your signal, XX% But unclear drug ran than trial, the reported trial is in about And data seen patients now you're homologue. wouldn't so Phase different is I LDL just low NGM, It's FGFXX – where signal to FGFXX baseline. out dose the our data year, EASL think including the of I of out with question compound. the pathway. is. that What It's in X reported that is OCA Phase can less signal excursion. what CONTROL sets is the in which the the The was reverse significantly a expect – that showing a LDL with that we've to at large second last several we've FXR or below we majority we a demonstrated atorvastatin alluding LDL we LDL on part of

to be you'd don't So see I the there what data at think any expect read-through should to REGENERATE. from NGM

Unknown Speaker

Great. Thanks so much.

Operator

you. Thank

from Citi. Our the question Joel next Beatty comes line from of

question, Your please?

Joel L. Beatty

and trial discuss finding for clinical where PSC taking forward Hi. Thanks Could at and that's question. just the and design? path next steps a you the for

Mark Pruzanski

Thanks the for Yeah. question.

we equivalent on PBC, roughly remarks, treatment approved PBC, no in the given opportunity disease it is patients. to there's absolutely represents really prevalent therapies. liver As new any where, one-third And devastating This an cholestatic committed compared it's about PBC. my remain to would fact despite be autoimmune unlike I that mentioned first-line, PSC a is to

endpoint based So the number liver enzyme hosted phosphatase, in a XXXX, endpoints on know I endpoint, clinically one course, included we in These there. huge Phos, while defined the in as FDA. recently things in basis least FDA they that for the speculate. what's to some take a little with that at Alk alkaline no in of that to other starting we've time. a X regulatory approval serum composite. potential workshop that's Agency. to saying time, want meaningful a pathway add And been of yet an be define And endpoints, don't PSC, going different discussed And was bit take a we just OCA's for by with on of where they expect time to need unmet we paper same coauthor also endpoint, to a expect was the there's but said, is it that PBC. same Phase

and other If in two NASH. definitive to a some get time in you there, indications, were pathway. we PBC several took pioneer remember, and to interactions It the

in our same this just to why, at guiding expect plans in We providing indication the that's moment, we're update PSC. the later this And an on year.

Joel L. Beatty

you. Thank

Operator

Thank you.

from question Fargo. the next Birchenough from Our of comes Jim Wells line

question, Your please?

Nick Abbott

were hepatitis morning. Good or POISE, recollection Jim that world of database. think, the Nick cirrhosis. patients patients quite mix mentioned in compensated is different of you Mark, that for from this that the a number were It's on autoimmune substantial real morning. overlap I target My with included

then, a receiving wondering I'm the ago, this if patients patient that to to OCA I coming a OCA reflected is So have And on are that population similar year today? the follow-up.

Mark Pruzanski

a as cirrhosis there's I so at recapitulation PBC of diagnosis Nick, compensated – patients presented the these mix biopsy-confirmed. all our patients with X far remember of abstract target X benefit. presumed recall. in because trial. say a Phase referring cirrhosis, data, the presumed Most And PBC of as these respect necessarily showing to that the Yeah. the had With of healthy I of on EASL weren't patients Phase you're they essentially, to well,

diagnosed were, with them of Some but non-invasively cirrhosis. most of them

PBC population who were to Phase that on program. we going see OCALIVA are our that representative target is of data and in the belief our So studied the X

Nick Abbott

think And that sick that a of that is coming today's reflective on? reflects wasn't group It population very was there you though this today? patients warehouse that

Mark Pruzanski

population stage of but the I and of X% the there has earlier about representation to exactly this advanced early said this patients here think the is with their settled required, down – X%, around PBC launched, was effect scripts we're population, population. overall cirrhosis, that there in we to before a modification's in in of days cirrhotic disproportionate Richard patients we the look, think the launch, of advanced in the dose where number vast general looking when sort majority at of That now, in were Well, channel disproportionate I right I'm believe. X% so Richard and in

Nick Abbott

less I Again, or of so And Mark. once are patients you daily. taking who reflective these think that expect Thanks, around are would of OCALIVA XX% is than what today?

Mark Pruzanski

I'll ask that. Richard to address

Richard Kim

drug have there's bit slightly of post a expected I as what lot little seeing, XX%, would daily little what being definitely than a bit a communication, safety It's the less were a filed, (XX:XX:XX) regimen on. (XX:XX:XX) We far Yeah. than that people that as utilization the were for that's there consumption hard. compliance a patient. less but So exactly we XXX%. from of obviously seen be can't variances say definitely drug we're to scheduled

Nick Abbott

we're yeah. – I think that

then, the site competitor Okay, There last EASL at the Mark, biomarker suggested just And of was that. Phos Alk was a a the I'll Alk in one. And Phos an to promoter gene. that in come region a use binding couldn't back they there as their was reason FXR trial.

in biology, leave this OCALIVA it a that. I'll – development? expertise present problem as Given is did with this your deep at FXR And well,

Mark Pruzanski

to the non-bile away but Alk in they look, actually Well, where PBC, agonist I alluding acid want Novartis' FXR to you're don't shied too Phase FXR, science with is what deep using of into data Phos. X from get interim here, presentation their

there the And before, increased range. it seen the actually, – I which Alk we slight and for we've don't Phos. evidence significant very all to demonstrated we've is change, all on-target saying on-target in this makes a respect Alk that Phos, an results non-cholestatic decrease the PBC that reported against dynamic is it's we're to in Phos and an to your there they're the more of Alk do question, see – Phos. – a think with in increase and PSC, in from Because standpoint, impressive. pretty what on an frankly, increase, stays going we've think to of suggestive Typically mechanism increase, going in show that the more synthesis normal I liver patients, uniform. the is reported Alk regulatory headwind that's

readout the it which GGT, was presented is enough evidence There's that difficult intriguing was it in go would think I to primary not to that EASL. but the be at GGT, abstract very reported. for

Nick Abbott

Thank you very much.

Operator

you. Thank

of the from from line Our Irina next question comes Cowen. Margine

please? question, Your

Irina Margine

correctly EU I Hi, my label for question. Lisa. understood A one If quick guys. was survey harmonization. the performed Thanks for the mentioned taking before you

was past And been have on this impact update just evolving the bit launch the more on geographies. based those touch you. how few the during you expect feedback briefly in physicians wondering if the the patient getting, then, has a on you to and I we generally, perception Thank discuss So could months? you've could been perhaps

Mark Pruzanski

go Lisa, ahead.

Lisa Bright

Sure. Yeah. Yeah. Okay.

that think go So, communication. is of into communicating the been this the right, yeah, last the And the of last since year, was towards U.S. it FDA research, the end January full as we dosing said, but now really I actually the conducted did we've appropriate year, key since year. importance

to label about perspective. So from and in had been kind confirm acted ways clarify everything an of talking reinforcement we just educational that many the

the label over I that of found that of and that just kind been months. the they've hearing both very So reassuring, the update, and certainly what hearing finalization providing of think previous its everything we're is physicians of have subsequent clarity kind

has probably and of confidence to to that prescribe prescribing, it's think there. look mean, different. intent I been So imagine think I start wouldn't reflective the I non-prescribers reassurance high and I significantly the would

on after happened And in course, this and launched of on bear early happened all for EU of label. life that the So largely Italy of some clarification the in Spain relatively largely these the mind countries. cycle all

at moving now informed we're ensuring So with label. clarity confidence just and appropriately I forwards that are around the think people clear

Mark Vignola

for time question. have more we one think I Operator,

Operator

Certainly.

Ying comes question of the final Our line America. from from of Bank Huang

Your please? question,

Ying Huang

taking for question. Thanks Morning. Hey. my

a TRx there Just any more maybe at looking Can bit than this maybe And in down little higher a or sales a bit your looking year, XQ the little quarter which this that. then months just component first little quarter but maybe you. ClinicalTrials.gov, for XX endpoint you on XX is script OCALIVA X%, any at trial quarter? REGENERATE, published the months. than about that XX color in provide clarify, why there versus is months? that's it inventory the primary protocol REVERSE reported the gross-to-net seems secondly, fourth year, to was is IMS on fourth here, is you was Can bit it's Thank

Mark Pruzanski

take could first the Sure. the if you Sandip, part of question.

Sandip S. Kapadia

Sure. Sure, Ying. Yeah.

we Medicare impacts I higher gross-to-net think and and so gross-to-net, Part of had of quarter in in D, have in just first indicated that's is the we terms a do assistance what quarter. sort just dynamic generally by forth the that copay, industry-wide first

saw the range. what So we higher had our the guided end quarter. best of first of in that's And we towards the

impact. that the So was effectively

buildup towards Now, there's the because like higher I that's not it's end but anything towards year rate sometimes the sometimes but refill with more patients end at mean, – dramatic. of inventory, that's the the to and of that, respect year,

the I think the key driver effectively is gross-to-net.

Mark Pruzanski

gained we've confidence Over X is reported your which our respect more have every this and way changes identical before at Phase to Yeah, we Ying, with XX-week Sandip. you're of about including near-term reproduce we a endpoint, on FLINT. our We, fibrosis, trial. histologic is time protocol, more REGENERATE, histologically, right, Thanks, as to said that other based time, in sets, FLINT should and flagship REVERSE points. REGENERATE to possible own data in real look, see the question that data designed course, and

the gave us really as as a study. REVERSE XX-week confidence opposed trial to, design that to well, one-year So

that compensated not a REVERSE much broader difference. I access, to there's on basis to our support with So is including with And readout goal timely market mentioned, patients relatively as cirrhosis.

Ying Huang

you. Okay. Thank

Mark Pruzanski

Ying. Thanks,

Operator

Mark the to conclude does I'd further remarks. CEO, to question-and-answer This program. you. Thank like today's program any hand the of for back Pruzanski, session

Mark Pruzanski

of I every you just in today. one to want thank listening

program, liver and employees our on growth needs we look you franchise, our driving of I with devastating committed indications, high prepared Phase X advancing the diseases. patients remarks, other Thank pursuing to our all As my in unmet disease much. in on forward meeting NASH remaining PBC remain of laser-focused behalf very leading to mentioned progressive non-viral these

Operator

Thank your you, conclude participation ladies in does for today's gentlemen, and program. conference. the This

You Good may now day. disconnect.

Intercept Pharmaceuticals (ICPT) 8 May 182018 Q1 Earnings call transcript