Intercept Pharmaceuticals (ICPT) 31 Oct 182018 Q3 Earnings call transcript

Company Profile

Participants

Mark Vignola	Intercept Pharmaceuticals, Inc.
Mark Pruzanski	Intercept Pharmaceuticals, Inc.
Richard Kim	Intercept Pharmaceuticals, Inc.
Lisa Bright	Intercept Pharmaceuticals, Inc.
Sandip S. Kapadia	Intercept Pharmaceuticals, Inc.
Salveen Richter	Goldman Sachs & Co. LLC
Michael J. Yee	Jefferies LLC
Brian Abrahams	RBC Capital Markets LLC
Alethia Young	Cantor Fitzgerald
Joseph P. Schwartz	Leerink Partners LLC
Brian P. Skorney	Robert W. Baird & Co., Inc.
Jay Olson	Oppenheimer & Co., Inc.
Yasmeen Rahimi	ROTH Capital Partners LLC
Irina Margine	Cowen and Co. LLC
Steven Seedhouse	Raymond James & Associates, Inc.
Aspen Mori	Merrill Lynch, Pierce, Fenner & Smith, Inc.
Joseph Stringer	Needham & Co. LLC
Joel L. Beatty	Citigroup Global Markets, Inc.
Yanan Zhu	Wells Fargo Securities LLC
Francois Brisebois	Laidlaw & Co. (UK) Ltd. (United States)

Call transcript

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Operator

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

Following the 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 the webcast of this call will be archived on the company's website for approximately two weeks. 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 third on XXXX we

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

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

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

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

Mark Pruzanski

we today's Mark. objectives; on exciting everyone, strategic program driving focused And you continued and and growth be our thank advancing Thanks, morning, remain call. for for Good key Intercept. our us XXXX continues an year PBC NASH business. two on industry-leading to joining development in clinical

non-viral progressive and medications from and As into diseases. remain millions of market we important quarter developing we the to committed the patients liver of XXXX towards bringing for move XXXX, fourth to suffering

REGENERATE, already clinical X,XXX of the guidance of evaluate with order final the be top-line designed enrolled Let regulatory X,XXX. of start our coming to our is in enrollment in confirm more total clinical patients our results excited we These We're are half the benefit outcomes well prior in OCA to interim post-marketing is XXXX. stretch REGENERATE our me target more in the REGENERATE intended first planned pleased the our way fibrosis. for to to basis. into readout NASH are than which To results trial, continue that analysis end, advanced of a on support non-cirrhotic through this than with approvals on study to to patients I'm flagship initial portion NASH. and reiterating have in this of

X commercial NASH is efforts We've the understanding trial physicians that NASH NASH. well our our data continue been cirrhosis. gained in we our with REVERSE target very trial, would patients U.S. We We've active and in of in other of dynamics which OCA the broader and in as patients enroll as this designed the positive important addition, efficacy compensated be patient from to with in an launch insights to into markets. believe our In Phase supportive and evaluate safety payers also of preparations. journey the NASH

be carcinoma, amount of greatest liver developing to progression at to our While market those on of the a there this liver complications research, quantitative primary unmet severe failure, of patients NASH the as majority and are of NASH, we've advanced Most diagnosed with conducted need the and with to who medical such believe with liver hundreds receiving care gastroenterologists, hepatocellular for In these with gastroenterologists. fibrosis care biopsy. liver-related and need cirrhosis, efforts death. significant physicians. care of Based without advanced blinded, patients patients transplant, appears are their we of a fibrosis found specialist work, are and understand market, the to better as risk and millions patients greatest were endocrinologists diagnosed hepatologists of under that hepatologists well way as

additional currently histologic and liver OCA is goal hepatologists insights of the foremost, investigational outcomes; the as insights for our have primary therapy that NASH. we research important and development remains features activities has clinical from resolution additional program our market endpoints; to which continue in Phase preparation our trial predict to are with to view only to approvable also implement believe well-controlled NASH to if been look gastroenterologists approved NASH, fibrosis improvement, shown inform We positioned and needs efficacy well as These these in research resolution. sharing we advances. shown providing a launch first and forward both improvement across meet NASH that key Our as the value. confirms therapy, fibrosis OCA X that

encouraged we growth, this XXXX continued to earlier morning quarter Ocaliva's as now $XX.X PBC. net by reported in million Moving sales. third Ocaliva worldwide I'm

and $XXX million reaffirm our provide worldwide our opportunity. belief robust, announced million details additional a We longer-term will net business of on following. Richard are our to XXXX reiterating represents And $XXX our continues Lisa and that sales. work PBC PBC previously between in guidance Ocaliva

Now onto our pipeline.

transformational plan, by additional While next our priorities combination as the continued path OCA, conclusion, for compounds development very XXXX, our exploring key exciting are the the to update. programs REGENERATE of Intercept we time In readout U.S. is prepare this it the PBC continuing NASH move year in our our to and and as efforts are with our I'll With PSC. beyond Commercial our that, program driving for to a be for OCA, Richard business, over the define and into advancing bile chemistry we platform for potential clinical company. advancing in promises preparing turn analysis growth acid forward development leveraging including phase for we what a interim

Richard Kim

and Thanks, Mark, everyone. morning, good

we For Ocaliva $XX.X reported sales. net U.S. million the in third quarter,

new patient and generally And the we As year, expected and August. we during a new mentioned see July we did this on trend initiations in patient flattening previous see summer. the call, less

in sales our changes PBC including to growth made to community-based XX%, that practitioners nurse in translate since seen this this However, the by increase sales solid stronger and covering year, along fourth and have our model will in we considerable physician offices. patient coverage Earlier we new into Labor Day, with about enrollment more quarter. anticipate we assistants gastroenterologists their

And enrollments these to more not changes. our the have new we expanded as since physicians. the quarter, we fourth from seen the come begun would as impact list see we While target quick of have of beginning of liked, have

During the couple recent event. a we with engaging American has presence at of key the months, customers. College been of last And strong team our had our Gastroenterology

we other XXXX. initiatives that quarter been foundation laid all solid physicians. on and next This U.S. into addition, we U.S. believe up have our growth XXXX our for sales force In we a continued largest as focus and conference, increased across gearing complemented our execution, activity has by the of in are activity of for have call week. AASLD, fourth continued key target We

have a team. strong commercial We

launch, into Our fits level of patients. a where for PBC their understanding reach at and level customers execution process and our since highest decision-making Ocaliva our clear their of have are

you to Lisa. over We are many patients with Thank more PBC. call And living help attention. your now the continue for to excited to turn to like I'd

Lisa Bright

A Thanks, XX% France of significant still and good countries a came saw net Spain, $X.X Italy, morning. sales were Richard, growth in expected, and as months. we such launch given early and some representing Ocaliva QX, million International sales during our in in from Canada. and Germany, summer quarter, the the phase, third versus expected slowness strong revenue portion from the growth International as

countries of averages pricing and national restrictions we As than International generally and secured without industry faster most for you rapid core major drugs. orphan in business know, have reimbursement our our for

need gated the have we certain still made regional progress. is by to negotiations uptake However, conclude great where

we very anniversary our region. the across adoption marketing by European authorization, approach are the we encouraged As of two-year of Ocaliva the

many growth first growth in to to significant since countries their a users seen continue Thank you. With increase prescribe in year future estimate have of in we December the in will QX intent XXXX. non-users, believe amongst and still strong International. to and prescribers We launch with quarter see relative third and we of of XXXX starts new a (XX:XX) patient in

to hand you me Sandip. let Now over

Sandip S. Kapadia

XXXX. refer update to summary release you I'd opportunity Thank an quarter our September you, financial on revenues a up morning, for XXXX. our in our to our total XX, third Lisa, to of Please We issued guidance the ended press recognized results of and in everyone. quarter today QX financial take in for the the position, $XX.X the XXXX. XXXX XXXX, million good give earlier of quarter like in revenues million third our and for from cash results, $XX total

sales and the a net of comprised with $X.X in sales XXXX. increase million. a sell-in change method. of in method sales sales deferred Please ex-U.S. Ocaliva the The note net U.S. of third the $XX.X approximately total third the versus net revenue that quarter connection XX% in net million of in quarter Our we've were recognized growth from represents to sell-through XXXX, of revenues $X.X recognition our million in of

for grew our to deductions previously Ocaliva quarter within the net Excluding of the to XX% in impact recognition communicated net of XXXX. third quarter of our the as XX% this policy, XX% change Gross were quarter range. in revenue sales the third XXXX our to compared

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

the of cost prior-year million compared for sales Our quarter the in to quarter. as $X.X million $X.X were

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

primarily was $XX.X spend the driven by expenses third from in to other of on in to our million costs. expenses organizational and primarily prior-year to development with Our and The administrative The in decreased XXXX, million the expenses down and $XX Research connection quarter development $XX.X focus from cost selling, efforts decrease consultant NASH the priorities. personnel-related lower streamline $XX.X SG&A general increased third and was quarter. XXXX, million in up OCA, of activities, the quarter prior-year key increase by and research driven quarter. million our

$XXX.X to $XX.X of expense the $X.X recognized quarter-two moving notes. and financial sale on convertible outstanding approximately had net cash, securities of This million XX, investible decrease million. of XXXX, finally, cash our also for guidance. end our We our And the for a as equivalents, on XXXX to represents And of to XXXX. versus cash million interest of moving December position, quarter we related available

we As million on to $XXX sales range reiterating announced our are the the call, Mark million. between net of full-year previously in Ocaliva mentioned $XXX XXXX earlier guidance

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

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

organizational a approach preparation NASH XXXX, expect priorities QX focused increase we launch an While in spending date in have as to we we do activities. our disciplined on our maintained expand to

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

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

Operator

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

Your now open. is line

Salveen Richter

taking for questions. Thanks morning. Good my

you regard One, some to metabolic that have to you're Thank stands the and that been the on impacting, in with get comment just with in payer we some that how NASH different just you. And just And base. then may what all, front, into recognize doing there. insight have the PCSKX front regard occurring at secondly, sector. work and that's discussions second-generation that can two FXR program? pricing I be dynamics the been on might if when development there from But NASH. the on your space NASH wondering So where

Mark Pruzanski

ask Thanks, to and the question about Richard Salveen. I'll the payers take second I'll answer one.

Richard Kim

Salveen. Hey, Yeah.

as yeah. – So,

As the know general, a a the to about quite them a on. are about that clearly thinking thinking early. very we probably still And that are as NASH are bit. payers market far attuned say payers concerned, lot. we going actually In dynamics lot are We're it's I would of

I in think think X see they're they're to their around data the waiting marketplace. as quite (XX:XX) well. I radar the from early process thinking obviously And whole Phase

abreast staying as attuned in going to with to collaboration And what's develop. think you payers future the we'll I our So is going keep a on. priority. things top be We're

Mark Pruzanski

as thing with highest to on the is FXRs, and strong add those put you a And unmet our and in value I be data you coming I advanced to XXX. in differentiated next earlier other properties only at to have into that development we need a now. get would to with hold know, won't next be we'll pipeline, out, that, have year. respect reads year But detailed our getting right a mentioned remarks, in again, back back as population. tremendous two the depending And agonists, advancing we've and in unmet will our this Both there's much second-generation remarks. focus on INT-XXX With fibrosis. that, in our do how that compounds need mentioned more proposition We is I update on year prepared as Salveen, Yeah. different patients the least FXR my

Salveen Richter

you. Thank Okay.

Operator

you. Thank

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

Your line is now open.

Michael J. Yee

and a force to questions. a Thanks. in just efforts ask sales quarter. much effort. up sales detailed, morning, versus, new you and some CV my up mentioned good a comments much new for you two new picking And to certainly picking were be you the about just fourth can you've comment guess things certainly you in to you the just could on things force that I excuse was, quarter. efforts, And If second then help XXXX? is contribution I how bit sales Can force – you've me, is obviously how are the to look people obviously Good congrats the everything. expanded or not could your are REGENERATE what is that appreciate thought you One wanted think study, comment made but focused on say, how going and powered But it at events. set seasonality? question about for expectations,

for top about the small there, what Obviously how possible event initial an So that? type about just able comment, could in maybe the issue in what of FLINT. it you would that and back Mark, you think is to talk where interpret day we was line? be should And numbers

bit. little a that to Thanks. talk just maybe So

Mark Pruzanski

to Sure. question. the take Thanks, Mike. first I'll ask Richard

Richard Kim

Hey, Thanks. Michael. Yeah.

very Michael, where made opportunity decision PBC what lot in yeah. patients our to XX%. our we across base as from earlier, our new We've far of expanded expansion initiations the new relatively we where We our And that opportunity And that in future. concerned, believe talked starting fact country. is the that greatest about important mentioned growth lies for are base. (XX:XX) really is I and PBC the growth a coverage, our huge is that is about expanded increase the as a are treater can our I by say, seeing As

this I growth opportunity going gives to hit I stride for good us XXXX. So here. starting think into And think continued our really we're

Mark Pruzanski

cardiovascular prove to statement, for a significant CV with respect relatively demonstrate have broad use risk. a population certainly patients. mean, I is going at just NASH that is And I I safety think mean, events, of will a any Mike. population be in to chronic drug Yeah, to adequate to large this what

FLINT. anyone to conduct part as me for cardiovascular FDA that the to of was it's sense or reported adverse part now was really the was kind this from of else right for nor Clearly, of cause There outcomes as what You we any in think out monitoring mentioned, mentioned I readout, there events are safety you will be NASH we that major FLINT front. Obviously, and in a trial on cardiovascular be premature FLINT. one required But not program. exactly don't cardiovascular and would concern tell you – the get will it's adjudicating any data top-line.

Michael J. Yee

Okay. Thanks.

Operator

Thank you.

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

is now Your open. line

Brian Abrahams

be I'm some I Hi. suggesting developmentally in wondering might an pruritus Thanks questions. overall plan viewing way your if then the space FXR emerging guess, off, that space for taking in might and Two potential the as that follow-up. I data you questions And And my competition curious or might shape first NASH how or – me. on-target a have from effect? both the the approach, commercially? for of you're

Mark Pruzanski

a possible. characterized it's pruritus I patients thousands At see treated be I there and in That the Yeah. bile that in various least. well and populations. in to the seem But data clinical OCA where We've stress to it's different of in made and have to expect other not been with where learned development potentially we manageable. should question, thinking they it's the effect majority the presented setting because years Sure. something and both own to the very doesn't an scaffold now thousands referring is case. post-marketing pruritus companies to is that of well patients. away. experience, that it a not non really on-target you're good more vast are bile again, to very terms eminently we have more effect. acid FXRs exposure, But programs in Look, think of in it's specifically known is an we've PBC this dampened date, of have patient acid out respect of or our that go compounds our of dose-dependent claim that manageable With think have that I we side least are the many – would eminently drug respect with that where that

Brian Abrahams

just Mark. really a That's And follow-up. then helpful,

of And You your some see the focus efforts, might under your interesting of market opportunity specialists. mentioned being more accurate with you the approach, on research sort a educational remarks commercial in prepared whether for stimulate NASH biopsies how care patients where just and that your I'm fibrosis impacts to an curious use Thanks. of diagnosis. you

Mark Pruzanski

Yes.

they a So over to been, their that care. to conducted calling great care, biopsies it of has are lot about already diagnosed patients a Right? of exclusion to they they're a NASH this what's we've in that is And customer fibrosis, research Appropriate I'll and market It's specialist PBC. date we start and the vast target way gastroenterologist. there exciting. receiving not is what hepatologist, tend – The been – – is are majority very that for it's that confirmed is that to as basis Richard. the hunch diagnosis in diagnosed with specialist And patients. have A, are make of that diagnosis. position hand quantitative our B, base precisely advanced on that

to And know don't for you anything we that. leg gives to prepare a NASH. plans as our really Richard, launch huge if us it I up add So have

Richard Kim

be future just pending would today. to our hepatologists and this years and in target as on that over quite No, coming are grown key in know gastros well. years say future, they The last approval, target the the key in marketplace our the Europe, the well. two we've And X.X Yeah. I in up would U.S.

from truly a we've well. we can of lot of what we're we've built very focused doing, what insights out we done So a expertise think as our today, our team leverage NASH and

So next experience leverage we indication. our we that we plan the feel good as can about for

Operator

you. Thank

line of Young Our Alethia comes from the of next Cantor. question

Your line is now open.

Alethia Young

me. Two guys. related from lot I a this to my ask trial. statistics question. Thanks Hey, people taking of about for One, think

have considerations the your question and kind able being you manage or to it's just can your about through confidence a get And also then you guess, that in the a mentioned the not? talk ways treatment just second that little script is in bit whether level found without I different people to So and hierarchal statistical biopsies. of analysis

impact Thanks. kind bit a or little of give us? just you maybe example maybe more can real-world us a So that for

Mark Pruzanski

With investigational Thanks, to course, my the endpoints. endpoints. got histopathologic we've on Sure. only study either we we Alethia. second... I Phase I'm remarks, power the in first, comment one can the trial power going the underly conviction shown our only achieve in to REGENERATE that as I And data can in terms benefit endpoints. I drug we that X robust where, while mean, these early have of to respect was in that the announced the succeed NASH specifically both REGENERATE prepared good through those to works said we approach, last approvable generated having then before, powered hope all of to reading not both, have year, on statistical often mentioned of FXR drug out of approvable the X a more as continue approach, hitting FLINT – with statistical study we well-controlled And features able And very of on in we're except we very have as advantage And the say And both both. mechanistically that I've has endpoints. we much endpoints. both OCA on Phase well our on further both that as efficacy were say, to

Alethia Young

And then...

Richard Kim

Patient journey.

Mark Pruzanski

Yeah. Richard that. I'll Patient take journey. ask to

Richard Kim

Yeah.

of the impacting that first of a a in patients. that name lot is the be beginning can remind potential think about is at diagnosis, mean, As far thing other non diagnoses as having NASH ourselves I in the concerned these we I exclusion

as and and we're also field. I others evolving going in I technology, markers, learn I to are think say more serologic some support it's (XX:XX). the there's will an diagnosis non-invasive continue used And on. help think think to Fibroscan But I time also goes the to of

Mark Pruzanski

away to that what's true course of gold Alethia, Yeah. the And biopsy disease, patients stakeholders, technologies Phase the authorities, is add way diagnose biopsy have employed been regulatory others technically from X to standard only our interest non-invasive the all to remains There's biopsy. And these know, hepatologists, in would wants thing, ultimately studies. been as the while I everybody themselves, whether and that altogether. to you get in definitively evolving gastroenterologists, non-invasives replace we that intense

Alethia Young

Thanks. Great.

Operator

Thank you.

from line Our of next question comes the Joseph Schwartz of Leerink Partners.

is now open. line Your

Joseph P. Schwartz

Great. Thanks. congrats the all And on progress.

So of of pipeline PBC in lot and programs you there's but in have couple industry-leading a areas. NASH, both competition a

you So can to lifecycle doing, have you give into up you're forward? about us what you what can insight some going your position how competitive shore been more and more thinking management, do

Mark Pruzanski

see say that are category thrilled are innovation really innovation, to all going disease. need. really lot on in this We've can be of of that Sure, led we all what I'll address tremendous first non-viral a of one to gratifying the Joe. medical progressive it's other No thing way unmet is And liver and company with to pioneer meet the a needs.

the to This patients ultimately that's benefit is point. there. out first of So the

where been exploring not a for NASH combo in also Second, liver cholestatic not still. a but standing scenes, a regimens doing the And about look, not we're but behind think work disease. lot of of are lot only people leader, only we the we've potential combination in

things yet systemically of we FXR, – And lifecycle by diseases. believe elucidated that lot are there from pipeline. the in, are play a fully been of regulated pathways for frankly, a additional lot for standpoint, PBC compounds example, have that other example, and at in that a haven't We

as standing years going believe we're then, in days. irrespective so. it of going still. And be comes the all several the – therapy competitors. in it's next more unobstructed evolve really activity, of the have is marketplace over NASH, we PBC This So We decade to remains despite early in or of what from to not second-line course,

us in So, from more prepared look, year. remarks, next look detailed as plans I mentioned for my

Joseph P. Schwartz

some then work in And treatments there's increasing Thanks. NASH helpful. might That's showing that behave Okay. NASH different and ethnicities. differently

demographics different So, to you the do the you've patient you less subgroups OCA or potential about in a of at the how as look REGENERATE, more in show for benefit feel enrolled?

Mark Pruzanski

Xs – I call potential a past And in and, think set is And Well and what as running companies that is Phase so of that our study. differences still phenotypic fairly it's understanding REGENERATE trove – in to and We're ethnicities ethnic in and that it's going genotype the heterogeneity. its western frankly, provide of in drive treasure or over really that any chronic in the of subgroups really a and about understanding data to will genotypes disease, NASH whether the subgroups commented of in a we've we forward lot disease is other data our the of early differences regional diseases. time. large evolve true different

Joseph P. Schwartz

Thanks.

Operator

you. Thank

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

open. now is line Your

Brian P. Skorney

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

the here granularity situation just were took read now try being and XXXX, three biopsies of only – biopsies this being Were having or as you and are pathologist, the what's all in Thanks. analyzing pathologists? a the refresher data. timeline, remind to along, next were independently as where then, one data? two think is a is the read? them to scrubbing analyzing terms now the read all And just this step by kind REGENERATE the us of process readout in independently And pathologists, again, and were you they saying the for some to you half get we and us taken, give process accumulating about Just first the

Mark Pruzanski

first, remarks, kind And biopsies in along. – is getting do This the I stretch multinational they we're now curve the there as at a in interim study. as study of are the Sure. gear Thanks, we the in analysis. two enrolled Brian. finished And my of of of they my to remarks, I the by mentioned Look, read the into large we course, them up in mean, sort go are are course, But the in pathologists this read mentioned for as as I the final we stick patients we're enrollment in yes, hockey be over really X,XXX study. central reading cohort excited that study. time enrolling at of biopsies. in interim And the

So read scrub tremendous a Biopsies there's get it's any this, are the data they with of large And top-line study. a stuff underway amount huge to work results. of to database and read lock data and go. as ultimately a like of out course,

– on detail repeat is provide more any and one we you no harder than to this to half. readout. we're this can't other excited more that point our on working to So of is than excited But are, get guidance first at point,

Operator

Thank you.

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

line now open. Your is

Jay Olson

Hey, on all for progress questions. taking and of I two the had guys. Congrats them. thanks the

one place research launch, behaviors? that to for than conducted. endpoints was relative you ability characterize importance was to if build you've existing terms NASH to preparation you The out infrastructure fibrosis the in the in behavior level did PBC? characterize of Thank relative registrational related market it of could NASH infrastructure have in that is expansion influence field resolution the of And example, NASH how find And extensive two already could in force you the then commercial would more first of And just comes be for the curious I impacting the you their or the and you. to when envision for reduction prescribers quantitative that significant of terms payers. to of you that

Mark Pruzanski

the take question, I'll was... Jay. first which Sure,

Richard Kim

Market research ...

Mark Pruzanski

improvement that, quite predicts call the – resolution to is and all particularly that saying, outcomes. is sorry, two pretty we've research, – on endpoints, was important on fibrosis. fact, evidence I an stage fibrosis stage I second. And the yes. progression the the meaningful far, Whereas fibrosis so, of long that's Again, focused fibrosis extensive very reason has NASH we've liver-related approvable And simply, more NASH the clearly been there's and as clinically failure in or been And cause we less so The confirmed for fact, now apologize, and endpoint. risk done really that the one. much quantitative currently research. for market Market advanced as Yeah. associated mortality. of liver the what

and who resolution looking and this is clearly NASH really we've also a incrementally accepted physicians – talking by understood benefit. So but for been that to, fibrosis value are by the

Richard Kim

cover our think then, be options. as But to are world as our the Yeah. build-out of And us perspective, top across gastroenterologist as Obviously, we we're going is have field absolutely NASH, our will more of I customers. to cover coverage. still priority for about need greater through mean, clearly we covering swath working are a essential to force far to our some NASH. When the far planning I as and our customers Jay, for strategically get hepatologist we our the mean, we as

Jay Olson

taking Great. Thanks for questions. the

Operator

you. Thank

Our next Rahimi of question comes from Capital Yasmeen of the Partners. ROTH line

Your now open. line is

Yasmeen Rahimi

is my Two discussion. on Question taking for one questions. you questions. Thank team. Hi, sort payer the of

they see is linked in, then, And given So anti-fibrotic Mark, you acute that or therapy? would fibrosis to as that NASH that have one as claim cost claim And resolution? so heart view NASH more follow-up zooming drugs do question. NASH chronic effects drugs then outcomes, that do payers pricing just I an mentioned, than for

Mark Pruzanski

ask Richard take to I'll that.

Richard Kim

Yeah.

still a a going the are the they're think NASH think products payers, bit say they for as But generally on their would and products thinking top we now, definitely impact they that see metabolic waiting to see ability the well. shape are, a going to I'd and itself. I readouts And with their have a priority clinical data sort there's lot are on ultimately I think to help thinking of as mean, segregation lot of again, I right the once education of think, really us. of think I payers process a in about about where early NASH. between still definitely I they more

there's payer to think the sort more around come definitely that. and how I be on So insights of endpoints evaluating they'll

Mark Pruzanski

Yasmeen, I that few highest – Yeah. this and drug is easier a the fibrosis, is improve to an unmet that it's that only can I – given of argument out the I minutes a value advanced in would there said certainly to proposition, add need to the think, fibrosis. easier position make again, thing – the where can that a and, link drug an to address is ago outcomes,

Yasmeen Rahimi

some And is of placebo going follow-up then to – rates. back my sort maybe to Thank question you.

long. the in their we lifestyle variability trial, loss/gain, contributes or trials diet are weight especially the know So or to loss, changes, NASH the when

how trial, So sort in these it can are patients some monitored of provide the comes REGENERATE insight when us specifically interventions? you to lifestyle

Mark Pruzanski

I – great Yeah. you're question. endpoints, around mean a two it's think placebo responses And And a to so, of XX%. the have on fibrosis tended of

concept see the they it continue trial, Phase percentages. any that we such it that conclusions to that sort these control. how just our on a Right? the lifestyle don't don't efficacy diet probably – have But these with you in response. are draw coming that But frankly, placebo actually they and drug respect And behave reason patients trials, just on All And to it For kinds of well placebo this REGENERATE experience, NASH to in to of would the you of course, as basis. to examined with seem it's fibrosis, is if believe well-controlled it's lose not responses. any important at profile get something fairly regular do monitored data. running the My to can to respect regular tended clinic. on to to – And reason there's entering consistent proof have patients higher I striking, such better. of X is in and counseling, investigational NASH difficult that's very but of the as that be do they're be stage because studies counseling. the case some particularly emphasize don't least on trial, of your account is respond the single-digit well-controlled variability resolution, know the They just at for personal basis They hypothesis there's a they weight biopsying being placebo. in in

Yasmeen Rahimi

for taking you questions. my Thank

Operator

you. Thank

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

line Your now open. is

Irina Margine

indication I NASH point, total any many was patients in comment used you. currently enrolled Thank latest NASH of maybe of this understanding the I have wondering if in the treatment? patients, blinded And how one have of guys. morning, widely Good you do are at not, you how trial are U.S. statin on then more. the perhaps could in And your being both EUX? and on statins

Mark Pruzanski

Yeah.

course, So REGENERATE. in remain we blinded – of

to So designed use manage to statin world. I as cholesterol allowed to don't the to care study, say not, to addition standard REGENERATE physicians allowed statin have any except a with patients be was that real-world around we of we of as respect the insight on or statin

think is their which CONTROL is LDL this the cholesterols on representative, before, were statin. what and our three statin-eligible those though commented from actually two-thirds where and that can fairly we've patients tell study, were of on one-third were, patients So approximately on least I XX%, of we you to at quarters a based

there. the not gap So, dyslipidemic use be And statins EASL they've a that. the out of there's certainly been to and shown recommend safe study CONTROL and surprisingly, AASLD our because of in NASH Both corroborate results effective. patients

So, again, we disposition the the card in use statin we'll with find turn out REGENERATE. respect what when to over was

Irina Margine

well more being data just you to or bit in just expect color do Should give you. detail if type specific the indication so you as likely more you could Thank as on able on of endpoint, primary Great. a biomarkers was year. And on? release include sort you wondering Okay. anticipate and we numbers then second release will one, think an top-line the of I next that the the my

Mark Pruzanski

time, will be of course the all that over of Look, clear.

specifics a balanced but the premature disclosure right to be fair release, and and tolerability readout efficacy. and comment on a around primary it's of think safety, course top-line I on the endpoints of now there'll

Irina Margine

Thank you.

Operator

Thank you.

Our the Seedhouse line next Raymond from Steve question James. of comes of

open. now Your line is

Steven Seedhouse

quick statins. think Do Hi, have thank on one impact follow-up NASH-specific endpoints? just you you. Maybe statins first any on

Mark Pruzanski

to potentially statins in positively or histology no statins clear it's either benefit patients equally on statin-naive for added a off FLINT, when good REGENERATE, I statins believe marginal definitive. be In not some period benefit who But we confounding patients statin cirrhosis. about liver that literature took on There a don't to is on readout. over question. enzymes think was at had impact it's a that baseline statins. of or be Good impact appeared – so at patients on for statin, the to were will but we And treatment, readout look the – or potential versus efficacy with the respect there clear histologic on but benefit XX-month

Steven Seedhouse

the the magnitude others lesser looking – And the looking measurement of FXR FXR like effect some FGFXX. see than for That's particular agonists, other emerging including some DR usually datasets, AASLD, injectable that mean, Beta ACC or mechanisms aggregate helpful. on the Okay. new at unrelated, MRI-PDFF you obviously at (XX:XX) that's or but that is of the just data I for agonists

know from MRI either that detail And FXR mechanism or about XX as there's FLINT you weeks. modality? does measurements what you've published a at to So – about and were MRI-PDFF that, follow in tell the where up study just another last a year on I taken

some at the newer is weeks trials. typically Just XX measurement obviously of done in this

agonists? that, Thank sense other you. stacks of given a up FXR you how compared to MRI-PDFF by do So have Ocaliva

Mark Pruzanski

And Yeah. continues NASH in FXR let by And me that be assessment the that OCA And – both published end-of-treatment the fact board endpoints. clearly across the that in believe there's as that further in non-invasive NASH. shown steatosis were agonist was FLINT as drug reiterating paper XXX you reduction. that or focus the baseline efficacy been the a there who patients underly to was has mentioned But that histopath features a of fat on I investigational had an start corroborated that MRI-PDFF. includes on about in MRI-PDFF lot only and that

inform a currently resolution is or improvement scant clearance in the is really NASH in And biopsy. But improvement. other continue ballooning. a resolution on the is predicts either NASH just defined actual features tool liver. resolution PDFF remind hepatocyte histopathology that to evidence highly that that It's clearance fibrosis there's way that been of to We think it assess you, fat useful fat corroborated with to

is And a X. to see residual So considered not Steatosis or of of you zero want ballooning. for zero NASH resolution inflammation, even score assessment resolution. fat in the or

has commercial concept So alone yet while of role its a X, let X PDFF interesting proven. setting, tool to in in in be Phase an context is Phase the of studies, proof

Operator

you. Thank

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

line now Your is open.

Aspen Mori

Hi, Ying. Aspen on It's guys. for

quick one Just one REGENERATE. on

analysis expect endpoints two the a rate we both or can analysis, on Thanks. it would the top-line be endpoints, the together? For of respondent pooled for

Mark Pruzanski

succeed can study endpoint. the hit one you, remind we to on if either just So

So, yes, individually. we would read out both expect endpoints to on

Aspen Mori

Okay. Thank you.

Operator

you. Thank

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

line open. Your is now

Joseph Stringer

is potentially some Thanks assets, FDA discussion only cholestatic second there? thoughts is with potentially this it question. you'll the there it And be taking is, maybe it on maybe on again in-house combination not trials the high-level there? or other PSC some you Hi, or potentially maybe additional be comment potential next around Is my know question in I or next gating external you on with mentioned Ocaliva, thoughts diseases. but that? maybe factor you for year. for for or then endpoints program. you looking around liver And would around Alan. the maybe Thank combo the the look you. NASH on year a Joey what pursuing at Could Quick one taking mentioned

Mark Pruzanski

Thanks. therapies. but PSC, sclerosing a no Sure. need tremendous one with primary and Look, unmet approved cholangitis, rare is disease, relatively

marketed a remain as focus address absolutely ultimately regulatory on need. year We clinical patients from been mentioned novel standpoint interaction development the we But in remarks, NASH for that program, of has be imperative committed advanced it's in our to not community. surprisingly. this our therapies and to so prepared laser PSC on And a and

to we're be as thinking respect particularly PSC. But the next going detail And a we to back landscape I with contributed remarks, on evolving. That has coupled which to with in endpoints, respect biomarkers, the we with are to pipeline so broader as approach PSC. part of more to PSC prepared in our year that here rapidly fact the that what with pace been mentioned my clarify coming with has update

pipeline we in that particularly look are cholestatic compounds from but combo, We are – disease. be, could been liver or cholestatic yeah, of the liver existing OCA for we would differentiated, question, very second least, internally other certainly with landscape other with we there, out in look OCA. – have the could even synergistic we scouring mechanisms that we in the there at drugs our complementary have Your believe, do disease, treatment

the in new to more come year. So, on that

Joseph Stringer

you. Thank Great.

Operator

you. Thank

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

line Your now open. is

Joel L. Beatty

agent half Hi. taking also first like first in X a potential XXXX looks of thoughts reading on to be X Could half that NASH? its first NASH out XXXX Gilead's Phase of and Thanks results the drugs in then and trials for be as your and threat two well. you the with Phase OCA the selonsertib the provide with OCA just will It question. competitive two to

Mark Pruzanski

you're Yeah. I mean, right.

each essentially great just for different and we consistently, this a other. let reading to And me and be patients. say, of have top going out So a mechanism. said They on for Gilead do are drug this field. It's is I've with the great

which the a this an of drug that that disease patients in no backbone can FLINT, other did continue And that optimal in different demonstrate having NASH, believe treatment I we we compounds amount Ultimately, and and innovation agonist kind can options. believe establish to approach. assuming do do in our in benefit we that other REGENERATE company one are role therapy unmet and in of heterogeneous a added. an such committed to is of represents companies efficacy as the we've as can OCA FXR be we resource need. investment adequately the And from leadership population the fact taken space. that large address We have proud will Gilead this vast

again, and and lots depend of do to own. one This their Of the others And company best we treatment. the appropriate to room frankly, a I be on readouts Gilead course, And drive can I patients lift all Phase of luck program. no data But this present. will that education is and its going on wish get in this X said, here. like on there's Gilead major

Joel L. Beatty

you. Thank Great.

Operator

you. Thank

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

line Your is open. now

Yanan Zhu

our Yanan is Jim. taking questions. for in Thanks for Hi. This

So two questions.

potential you strategy which combo is, outcomes And would interim on thoughts could how second interim about partners? the around the desired you the question you combo And the able obtaining of the was analysis? the about drugs? potential talk on you then updated wondering space, the just call, would And question, statistical recent give are combo in briefly on partner activities some analysis? given to assumptions Thanks. mentioned I what us be First for NASH, go

Mark Pruzanski

Yeah.

a added. to have eventually time we have regimens It's that good both to say where And safety our for but call, see to – going other really but upcoming approach our in to results believe at backbone any formally combination, powering on statistical both NASH mentioned we and in we data I'm OCA efficacy on the OCA compounds from significant we to So, we are respect yeah, on days. in in presenting FLINT. emerge mean, be to With And the based detail might with are that is not which going we it a informed of assumptions we laser-focused mechanisms establishing endpoints And powering comment robust as patients endpoints of combos I to that for time long those conviction on patients come in statistically endpoints. stated will on REGENERATE-matched more both REGENERATE. AASLD both And early a fact, data cohort endpoints. you'll well-powered take a about for data treatment we be combination as therapy with data FLINT suffice meeting, approach, different have over earlier the market. I – fibrosis, in in the to the long in this on of believe

also Right? definitive really NASH concept. only of been out has other establishing few hear bar mentioned you'll from lot very, there generate very the this. biopsy approach we'll proof on I met a It with robust earlier, not are that to we respect in that believe approach And requires, Once have so but to optionality in investigational far. – just high us very We bar as have control and REGENERATE, than we And think NASH. drugs data. placebo OCA combo to then of more our that read how to

Yanan Zhu

Thank it. Mark. you, Got

Operator

you. Thank

of Brisebois the Laidlaw. of Francois question next line from comes Our

Francois line for taking (UK) Laidlaw & (United questions. - States) Hi. Co. the open. Your Brisebois Ltd. Thanks now is

here. couple Just a

we've wondering, progression So just of I of there better about was in of terms in there. Has small LDLs understanding buoyancy dense large been any progression and talked versus MRI-PDFF more molecules? terms

Mark Pruzanski

baseline out CONTROL increase is study we healthy dense did in we understanding with we will thought in for bud out the of buoyant question true majority volunteer and I can't what that HDL. with studies, that that of generic respect particles, There OCA the offer driven patients Phase are this, showed LDL comment drugs combined with are nip Well, We large last by levels. I'm tried LDL, say we But updated low-dose see subfractions can atorvastatin LDL in that frankly maintain your LDL done a X, in to which below in of terms year OCA general. to there. LDL than lipidologist. vast the less in the LDL about And say cholesterol with LDL. significantly and primarily further in reproduced be we've in decades lipid the clinical not I to atherogenic that small reported But show management except experience have of and medicine

Thank are are States) other (UK) that Francois to treat at Brisebois then you. - NASH disposal concerned ones. Laidlaw & patients. certainly physicians Understood. cholesterol two So And quick options Co. the and (United dyslipidemia about Ltd. of who in

wondering rep details. was in of I Just sales terms

Can more terms next being there that keep a clearly about, costs in in efforts. quarter? lower as numbers, And you the U.S. more in SG&A out for? are you into this of excited guys you to looking is this week, the AASLD to XX% give explain cut an little about particular In you that just coverage granularity eye just anything then, mentioned consultant decreased and

Mark Pruzanski

to Sandip first the ask I'll second. take the one I'll take and

Sandip S. Kapadia

discussed the of we our Sure. we mean, as terms priorities Look, advancement organization launch. year two the as well of on in how on driving spending, primarily think PBC focused in the program had on really refocused I terms Yeah. NASH key our I last of

see been investments overall. terms that's what the focused what in that's on we've of you So and

We my mentioned expand make preparation for to an terms remarks, activities. launch we start sure increase the in do the as investments in continue as And – of the PBC we sure. our as anticipate we right to quarter-four NASH I programs in we make drive

Mark Pruzanski

year AASLD. into always with with meeting along excited we're for is of us. important going And the, EASL, Yeah. the respect scientific to AASLD, most the This

and we'll be some have We NASH there. presenting exciting PBC abstracts that

as unmet liver look please need. and those. increasing see NASH on diseases we're focus for there always, So such to out tremendous is cholestatic And excited other the where

forward to as Co. into Thank So gleaning a number there Francois (United you. and right. States) All - of there, look we meeting. go more & the are abstracts (UK) Laidlaw we'll Brisebois Ltd.

Operator

Thank you. questions today. closing that And over time to for would is back for call we remarks. to the for all like hand any Pruzanski Mark I have the

Mark Pruzanski

Thanks, operator. Sure.

everyone for Just in very listening today. briefly, thanks to

happy in are year, want readout wish half company. with towards a stretch next We the will that for everyone year to are in with And be very excited here interim final analysis I REGENERATE, clearly which as heading we a first transformational Halloween. the

Operator

participating in you Ladies conclude for today's gentlemen, today's thank That and conference. does program.

great Everyone, all have may disconnect. day. a You

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