ICPT - Earnings call transcript Q2 2020 | Intercept Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Second Quarter 2020 Intercept Pharmaceuticals Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers' remarks, there will be a question-and-answer session. At this time, I would now like to turn the conference over to Ms. DeFrancesco. Lisa begin. may you Ma'am,

Lisa M. DeFrancesco

position, those you. Good on press for us our and thank announcing which accompanying are available morning call. This fibrosis strategy and on reasonable, financial results today's financial obligations assumptions subject and and liver XXXX a date estimates second you also due not on inherently financial morning, on posted our slides, joining to are statements, website as speak including Listeners no statements quarter Thank are our forward-looking and approved I'd certain we release NASH; be to at and be required including the prospects, statements, and making discussion, note to only These number potential products clinical during programs; commercial undertake like the forward-looking our development risks this and we undue matters, OCA to of reliance www.interceptpharma.com.Before our and our of that to by regulatory these forward-looking statements to of begin are future statements call, for cautioned believed call place will except and approval regarding guidance, law. we we performance. issued uncertainties. which as of based a uncertain that, although update

begin our from periodic one Jerry Sandip but and necessarily our to Today's question historical Mark public take by in to questions then or are Dr. the Kapadia. time our question. our call statements yourself Chief the materially actual Pruzanski, allow order Chief our results SEC. Operating from those remarks to all Officer, limit prepared the from Please will our addressed. predicted all to risk of followed your results for open factors be anticipated initial to discussed We'll Some Financial release CEO, filings differ Durso; Officer, not morning's and forward-looking press our that call could in cause those in this with with or by

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

Mark E. Pruzanski

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

Following and NASH the objectives. we've for receipt announced main been letter on XX, on response focused two complete of June OCA the

with and a we ensure of to for remain back financial Type of to with in strong prepare second, get regulatory our the A Based we position NASH our latest work meeting OCA supporting review advance strong to process NASH our data FDA conviction the approval the a and benefit our due fibrosis risk on treatment First, for interactions profile OCA that of reaffirm leading in the experts the US of on we've track. supporting to our as FDA, accelerated approval. NASH upcoming patients available to positive continued together with for with of application for

and As Phase risk you approval only REGENERATE become to accelerated to trial complications. advanced for NASH guidance data, produce believe X patients highest at well with cirrhosis and remains has particularly to continue progressing fibrosis its the know, interim OCA potential for foundational of treatment, a to FDA's positive the meeting we

FDA we for selection patient safety can any helpful even FDA stage Type the we management data post-marketing effective take how and to set need as further OCA's for available meeting, steps sides appropriate next meetings. ensure a fourth supportive forward be strong with setting. achieving biochemical NDA. and with of strong gratified A agency. alignment regarding data should as to the demonstrating of In eager This scientific conference on comprehensively gain to core resubmission of their In which may benefit to raised from we've while by reframing histologic, the a across to quarter experts risk this who upcoming views look productive will high has enhance endpoint received parameters. and our are we approval addition clinical well OCA's take efficacy the addressing advocates with sharing composite subsequent stakeholders benefit A to prove in the profile opinion-leading We the issues efficacy In to benefit expect FDA, range we non-invasive further believe important in the month OCA at tools basis analysis place fibrosis ensure risk, at early who primary patient parallel, continued NASH support risk anti-fibrotic significance, both robust through our REGENERATE on demonstrated complex, to have share to been ongoing of also and are focused statistical and reaffirmed Type the virtual meeting for EASL new external including preparing express and and our conviction

As to have. through we as any always, as process, navigate this we will remain we updates material committed providing

of resubmit EMA review would timeline, conditional on six-month express a anticipate the Regarding to and and views NASH we anticipated to remains once you MAA our review, I'd we where for OCA our to opportunity the the of experts then due reaching on meantime, receiving have we the on during their track. which that committee and Europe In NASH. anticipate publicly expect we agreement potential path approval advocates an patient remind would treatment advisory to fibrosis undergo NDA, like forward in for continues on as clinical meeting first the the that NASH merits OCA which

internal mentioned all review of I investments. undertaken earlier, we've our As of an

postponing course, have identified preparation of are, and We other efforts business. the NASH launch across savings our

adjusted still operating range continue to continue supporting the needed our resources to As our resubmit a to guidance NDA in critical business. growth foundational retaining million, our program, result, successfully our we NASH clinical we lowered while announced today expense $XXX drive PBC by non-GAAP that have XXXX

moving Now, our to results. operating

continues business global to perform Our well. PBC

Our with the $XX.X quarter sales performance was strong our biggest for since net of million, reported quarter launch.

Meanwhile, programs, and gratified you to and today to action we've little apparent combination its the our temporarily decision know, for to impact impact business. and our trials, global enrollment bezafibrate. to NASH X to been and had situation and I'm these Phase to in results signs have REVERSE With announce to plan randomization COVID-XX in in has screening outcomes trials, with other PBC clinical reinitiated ongoing trials. of patients see pause While herald enrollment closely promising these previously that fully X while we pleased enrolled recovery, our respect OCA trial continue some we and announced on of we our restart study pandemic REGENERATE as soon I'm COBALT the the our development time monitor in our Phase

reported the therapy, combination supporting to we the long-term development of conviction clinical value in Given our have the business. we've seen positive this PBC continue previously strong data, of

we have to Ocaliva continue successfully We globally trials. not for supply our chain for to our disruptions business any and supply product ongoing and investigational PBC experienced significant our product

relationships due highlight to over inspire of in Intercept We've support the NASH moment received fibrosis Before outpouring OCA and community Jerry, non-viral failure forward lead to to nature coupled value that continues the continue We to from result our we'll approval strong what support with of way this I within strength wanted This progressive of they available disease to NASH. of diseases. of our hepatology serious is conviction take the truly all to us advanced at an patients bring a and living mission a it I therapy. focused become turn remain OCA, no supporting with of to has the as leading and have on those the external have the we we in support of the data, committee. supporting approved liver to that with driving the cause liver enormous with broader stakeholders within

Now, turn activities. I'd our update PBC the over provide call and global an commercial like business Jerry to on to to

Jerome B. Durso

net performance increased demand international in quarter response inventory our million continued who total year see the see the early quarter some prior In continued results did to prescription period. to versus and Europe, of reversal we uncertainty Mark, strong we good $XX.X market Ocaliva our complete letter. XX% the These our highest of region, to from in quarter provide the quarter I'll customers proactively was quarter, the where discussing last the we adjustments the an the of we key the achieved sales represents as $XX.X markets. $XX.X prior strong is sales in on everyone. the and in million US we've versus good morning, Thanks, commercial you we since achieved Ocaliva activities which first In response and sales for net end two. reported trend ex-US year update date. we international of In worldwide have quarter. results levels received growth million the and growth In to COVID-XX our our the reflect net of by the quarter then quarterly start in second made sales a Ocaliva

has global but Ocaliva maintain patients of been pleased the Our the on pandemic. proven challenges despite business our we've COVID-XX be through to with ability resilient therapy to

slowdown expect, level one overall lower see As as COVID-XX issue. the at than you with when would remained impact quarter of in starts global emerge new patient patients did began second an visits, the during a we a which to quarter

NASH. to now Turning

significant identification and implications the due made to advanced of progress have efforts and patients. of the our to the these last months XX appropriate over on educate teams NASH stakeholders Our fibrosis overall

of conducted plan. our a We able of our receipt of Letter, take in our advantage operating forward had strategy going Following were commercial expected the flexibility lower expenses our we Response we and to the into built commercial Complete full global review XXXX.

eliminated have organization. we sales contract example, our For

a better acted efforts the future NASH that timely effort be on fibrosis refocusing disease interactions resubmission, and to-date. effect. to have field this our well the rebounding. devastation meantime, on the the based are research of redeployed made evidenced with in necessary core a advanced to and understanding by teams learnings the community. PBC the we've immediate on And to the NASH decision have a for as is our launch commercially growth is focus NASH for we've and that are and preparation regulatory from Awareness of timelines our our we've awareness difficult, will the believe within market our made our I lasting postpone have business. customer quickly of Additionally, our community Once results on scale including patients forward as PBC. In as activities of education progress but our path the we're necessary support as we'll launch US, well-positioned on reinitiate experiencing we

channels managers begun virtual with appropriate. territory to physicians where have through again interact business multiple and in person Our

again. For example, to PBC in shows field hear our to prior healthcare providers June, from our interactions research teams month market that the and our doubled are relative eager

reductions commercial pleased towards significant we've a steps facilitate So by efforts saving cost to Sandip expenses forward to-date operating overall, to And I'm sensible XXXX evaluate the our our our that Financial turn PBC amount. to Chief expected I'll the we opportunities those as our refocused call while reducing with continue over Sandip? for we financial we'll made update. and move now, Officer, Kapadia

Sandip S. Kapadia

morning, sales good for and second share June ended Ocaliva second Jerry, results issued everyone. quarter take and results, performance. Please of in our quarter, $XX.X guidance. non-GAAP adjusted with net XX, for highest you, a on with updates our the commercial to we net In to-date, sales, XXXX. I'd to our updated refer quarter morning Ocaliva quarter Thank our of guidance million full the summary $XX.X XXXX. our important recognized Starting XXXX this like strong the opportunity QX expense million press operating in to the from financial earlier our new you QX release our up XXXX commercial

Ocaliva versus quarter. comprised of growth prospectively a and sales the net ex-US of $XX.X sales $XX.X of and sales This year million million. net US second XX% approximately of Our XX% prior represents quarter net

Our were operating quarter our $XXX.X operating the GAAP $XXX.X for million. expenses adjusted million. expenses And were second non-GAAP

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

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

the for year prior and the This second increase increased million Our in were over represents $XX.X prelaunch NASH selling, million. of investment our $XX.X general driven primarily quarter expenses administrative and an activities. by was quarter

for credit. R&D the credit, R&D the the $XX expenses year Our tax includes and this anticipated tax with to of development research $XX generally consistent million the are related were million quarter the offset prior quarter. Absent expenses UK second impact and

year. we XXXX cash, our investment available now equivalents, XX, As cash the of cash approximately June $XXX.X positioned financial sale with and for securities were updated debt million. for well of turning restricted guidance And to

of half in million guidance sales year, provide $XXX focus in the on now this sales expect we year net million. commercial Ocaliva our to PBC net full the range As $XXX Ocaliva XXXX back we've efforts of decided to and

reviewed and Complete non-GAAP have plans million. and As In and preparation investment mentioned, launch our review, efforts. adjusted by to Jerry following Letter, receipt education we activity the of expense guidance carefully Mark Response range determined our we operating NASH connection this reduced the postpone are our $XXX XXXX with disease

specific While as to we updated we year. expect that taken into actions Jerry additional of guidance we've covered into range, details some the of move the second half this our provide forward factor

process between million. In a to to assess like With reduce initial and million remain of allow to clinical operator that Given focus ongoing FDA, expenses steps to will of business the financial disease. in be previous I'd we our million, to the range to to the trials. these now believe over combined range we regulatory the in we as summary, we we've continue and launch with with operating million liver any to growing as call steps on therapies to you $XXX expenses to important from pleased we XXXX future non-viral will with investments. expect year to assure business We operating that position growing taken PBC be adjusted taken expect expenses longer in prudent key and our $XXX our this strong questions. no We the our the continue invest turn the for reduce $XXX our I'm NASH we've $XXX support Operator? bringing with that, in down non-GAAP PBC fund us patients

Operator

question from first Our the or from Michael line comment Yee comes of Jefferies.

Your line is open.

Michael J. Yee

would on could the good that scenarios two or be if on ahead congrats or think you Maybe file could still just Hey, discussion pretty good minutes a shed meeting preparing A on a could would what us could to team, for light about with was be? there it you wait obviously, good you to get you update to clarity for Do and Mark quarter. a to us come as you simplifying you three Thanks NASH. think And meet year a year? comment think you PBC of morning. them? or pretty meeting some Maybe Type made the you Thanks. back this your back next quickly you

Mark E. Pruzanski

Mike. Thanks, Yeah.

reframe in Type I meticulously risk – of mentioned that we're sentiment NASH of really preparing aspects the the and of as our with A external experts prepared mentioned my meeting. experts very you as overlay So ensure for the we've stage benefit proposed here the And focused right we really set resubmission remarks, in now for been to number risk NDA. working all with a (XX:XX:XX)

If could be in month advisory after everything the material or six see second we review an then will A to an possible we can't support expeditious And mentioned expect course committee meeting case to adequate prior Type will resubmission months. which the is required timeline And go moment now while pushed clarification of but, a be a in average, look I as XX, at when the expecting I on. I update further. obviously receipt seen of the part of clock occur. call, alignment out you year to upon the think resubmission, to cases your of to a additional get a additional when time the CR precedents. we speculate taken anything resubmission, about do question to the on you the right update what come to – to alignment last since every data like in steps would And XX successful with hope then reach the will here spoke it's of we And toward we've would to also difficult would requested approval A range the in June course, on could from of if letter And on that speculate we've unique, to a this timeline be. CRL little somewhere have exactly we year-end. look meeting Type we we context to were single of work

Michael J. Yee

Okay. Thanks.

Mark E. Pruzanski

Thanks, Mike.

Operator

you. Thank

next from Our Yasmeen line comment Rahimi Piper or question comes from of Sandler. the

open. is line Your

Yasmeen Rahimi

Hi, my Two team. Thank question. questions. you for quick taking

is, what sharing can you is thank be for a And non-invasive the you? taking expectation shed informative The And with first one Type transaminases and is, questions. is FDA you bit little us upcoming can be could XX-month much your share to then terms of late-breaker you'll question light that the get us biomarkers? how A in our which second from you're data poster into meeting with the going the for you again feedback of the in

Mark E. Pruzanski

Sure, Yas. your And role. congrats new on

first well think taking A the with with that the key the meeting the again, resubmission. we part alignment reach chance most for division of we the stage that to to support respect Type review the time as the able really such I are issues we to constructive interaction for question, prepare are hopefully to really possible on and set maximize this

on We've PBC I month. So typically additional programs. respect be a interaction answer the end in CRL A working prepared we'll the that are Type abstracts about NASH alignment. on excited the with will more got we're provide end of at and productive. might required agency and really reframing previous With the to But hopefully both of and be letter of upcoming EASL, for them EASL be a very to for virtual as number steps the resubmission, question, so the to meeting well the this we ensure while reach the its to is could to here meant basis that a for that mentioned a the deficiencies, be we comprehensive communicate view following

late-breakers You late-breakers I I data months mentioned and on available treatment. XX we're are excited including And going with abstracts about that longer-term that or view be from highly able of patients mean data believe longer-term plus present exposure in now. that benefit most in all to late-breaker. I say are OCA made receiving these by in EASL – be would continuing are of XX that further general, the the to we'll suggestive our of days

Yasmeen Rahimi

meeting. you, Thank head and you into best of as Mark, luck the

Mark E. Pruzanski

Thank you.

Operator

Thank you.

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

Your line open. is

Alethia Young

Hey, just bit about to And is I what guys. and A, on could little depending my with way maybe expedite ask question. escalate a the Thanks just that potentially process. Thank further kind of a there taking wanted appeal for happens Type you. to help

Mark E. Pruzanski

Alethia. the Yeah. question Thanks for

steps steps And in the to So the focused we answer with review ourselves mentioned two interaction and the will agency. case absolutely we're division. we'll first previous A accelerated on the that as hope support a to risk we position the prepared the And that with Type basis approval on of really here questions, data to constructive the to very benefit I for absolutely continue totality be both what in do take the much view and of make of meeting. additional is our to support highly sides have

Alethia Young

Thanks. Great.

Operator

you. Thank

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

open. is line Your

Joel L. Beatty

any when Has you the a future REGENERATE for taking Thanks trial? outcomes Hi. seen they data is possible refile? could the Thanks. FDA that that in ongoing see from it And question. unblinded

Mark E. Pruzanski

Joel. Thanks, Yeah.

unblinded interim protocol as we've that's study the analysis, remain FDA time-to-event a is this the possible until plan. the on the the is provided trial end the agency but data in analysis of outcomes currently as study. statistical access two the way or way and the the data sponsor that It not outcomes are month again, right could along theoretically to So for after designed, blinded outcomes XX analysis,

Joel L. Beatty

Got it. Thank you.

Operator

Thank you.

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

line Your open. is

Jay Olson

away questions. Oh, a PSC from diseases on to NASH? for a you study hi. Intercept liver pursuing how strengthening meeting potentially in developing A PBC strength the your walking Thank OCA strategy of and rare including on focus would Depending for narrowed FDA, goes by bezafibrate and of Type combination your the OCA the leadership taking the position on based with with possibly consider AESOP

Mark E. Pruzanski

treatments answer fibrosis approval our course, our Well, OCA out enormous launch, entire are data support point them. would be for mean, your look as no know know the But has as to of as the we NASH business think planning of in grow. NASH first, question currently back that patients and now I think in you we're has company PBC important is PBC you to to confident I with huge with for Ocaliva is focus a that hard business in to to starting advanced the of NASH. program quarter Type much and And continue continues the have treatment and treatment I get which get of – from of to thrust available meeting is our the eligible are reported first we right to work to value – is ensure of on as the is first patients who I track need with that review record a as possible And the A committed very since and who we worldwide. treatment foundational REGENERATE

to the to flagging, company continue up have strive in great business to foundational eventuality to continue unexpected that we'll you're a build on. we that business. the certainly build And So,

Jay Olson

Great. Thanks question. for taking the

Operator

Thank you.

from or comes B. Our Mamtani comment line from Mayank the next Riley. question of

open. is line Your

Mayank Mamtani

Thanks CRL. the taking team update and detailed this my appreciate for question on

had have context thinking I be versus, set for said more Type data were might So risk, in you And what on? working be what think you towards on incremental what could context pre-AdCom you – you about could for this both you very that, that specific that of might AdCom benefit your A? your the the early before on but meeting Type working quickly of any you and may package give comment Mark October in for you A. is be

Mark E. Pruzanski

a read last there of remarks, And Phase on – to that generate these for that of further the specifically analysis our advisory that continue intra- the of Journal Davison study a a for (XX:XX:XX agency and inter-reader paper an this benefit amount XX:XX:XX) conviction by the in in pathologists' that the support additional risk of a variability And assessment, [Technical comprehensively to you become et preparing looks Difficulty] literature basis. treatment preparing importantly data, benefit. is committee, for REGENERATE year I I categorical to additional in in underestimation variability the of has of the endpoints in more the lending under And of before this that's Yeah. with decent well-known to all in really the example. actually recent right of prepared as and review. statistically I'll now we course context the you again really inter-reader this fact now the mentioned point Xb press out the al Hepatology they in from drug. along the quite context what is uphold at I've give intra- semi-quantitative that dive the meeting, the not on of histology of the have additional one deep NASH that we an supported seized context in an powering mentioned a called analysis conclusion surprisingly did that effect. Type EMMINENCE. will studies fact And in does and in endpoints variability And A lead the

of it's to this high again that to important the now in overcame of of the those support And fact our FLINT note study we've fibrosis which reported noise REGENERATE, that well-controlled course the studies, variability and significance in so then is both trials reverse two ability statistical the results in pivotal and with showed OCA of unprecedented. robust

that's one So, the just side. example efficacy on

of evidence reassuring of that's is looking assess This liver safety from that and in there or who that And And in I study are I groundbreaking with portal very call to a the of reserve, can are that mentioned the safety status XX that are think course of profile, an on a hepatic entire other the and case that strongly really assessment an impairment did the liver the really hypertension. these. doing patients that the and we clearly safety health any significant importantly hepatic at routine suspected every who is cirrhosis confirmed exercise our from enormous comprehensive most profile of OCA's this perhaps lab expected parameters piece June safety in at was patients and population. had liver piece side, safety relatively important cirrhosis declining we On work additional across work context. with have on conclusions side. is single These standpoint significantly of of straightforwardly safety greater like used patients risk identified liver functional be non-invasively clinically tests NASH day

So, that's framing something we're up safety that on Type an meeting. important the side example the of for A

Mayank Mamtani

Is received, that should one-time quarters? coming the else modeling I quick helpful from UK can I great. Very a the ask for you That's And something if thing or on Sandip in government. Mark. quickly color, credit a we follow up the be believe tax R&D

Sandip S. Kapadia

model thing that operating but Mayank. payment and quarter. we the us that's our annual with we're I you, would they we applied a in, it effort to some I years this certain say received our Hi support the have That's We've certainly certainly percentage we for that few you the pleased this expenses credit of progress an pleased UK Yeah. benefit as expenses, of here. it's the a It's back. that Yeah. government for offered a here. by Sandip wouldn't R&D update the our mean, reduce kind allowed of plans, which very to we'll – that we're – obviously as on make and but continue on provide

Mayank Mamtani

question. much taking Great. for Thanks so my

Operator

you. Thank

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

open. is line Your

Brian Abrahams

part my thoughts CRL any and may taking that question. of in OCA formally Thanks some you NASH the then risk AdCom data you as whom for FDA's Thanks. subpopulations AdCom. maximally this heard analyses and benefit specifically of much expectations benefit be any from appropriate to resolution also of relates so may differ Hi in as for and there. light the that overall you the you reframing? any whether of yet there of to process of overall requested have so, guys an mentioned for evolving Can more writing? view Have could if dispute share sort idea how And an

Mark E. Pruzanski

patients Yeah. Thanks, had you that in well Brian. With liver patients stands which FX fibrosis is outlined studies, who commercial day potentially we the clearly that's and we of because in value as NASH progressing its (XX:XX:XX) are greatest to cirrhosis respect with with the your very risk said, NASH the on where range part breakthrough focus indication. population to is as at we know the specific with think we of OCA is, well where the the proposition can That know, in most unmet good. early first fibrosis everything highest fibrosis question, highest our advanced do you complications, and designation initial where that's the December our need and from that's to of fibrosis a

a in overall So the that's to subset benefit indicated that assessment. their with of potential risk I the frame represents and agency important up already population framing do think

NASH for aspect advisory to cycle of of absence for of be patients the to one whether of And wake wish is that focus the what the is NASH an that your incompleteness the and first again, versus the prepare was merits resubmitting second repeatedly now we've experts of or key an assumption stated And review Type OCAs opine on steps committee. publicly of the advisory that to needed, patients respect right requesting again subsequent comprehensively will assuming agency opportunity The our NDA may now that for upon with in was and meeting. have the meeting with for clinical part question And A to that continue treatment fibrosis. the our right sole committee. to

Brian Abrahams

Thanks so much.

Mark E. Pruzanski

Thanks.

Operator

Thank you.

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

Your is line open.

Jim Birchenough

Yeah. yet. on view street to avoid Thanks. the alignment? getting you hear how that do How is alignment guys. want reach true not of a Congrats you hearing letter, what that off CRL Maybe do communicate and times Hi, to few but FDA's and the the and quarter. that alignment with tough to your of view question you a Ocaliva you've clearly looking to answer, FDA there's mentioned alignment alignment

Mark E. Pruzanski

of it being and up where Thanks, something meticulously transparent of terms in participation with submit base both and book as expect we Jim. that we think lead constructive, Look, meeting briefing the shortly we in for prepared to on views to basis a set for the that stage the a truly I the and can up the set alignment exchange hopefully – resubmission. starts

to the moment resubmission on I to meeting that interactions enough up have think it's course, follow communicating like. right that you. speculate feel we on, to agency obviously But Of required we'll any where exactly to from we look base at it's now difficult that or that's the whether going be that what

Jim Birchenough

that be at meeting? And that to the data new and you Mark, FDA the is that to you'll data Type A would EASL bringing are present

Mark E. Pruzanski

really we the mean, have A be I intend to with see with of the focus new Yeah. sure present at include efficacy in fibrosis to will opportunity on prior EASL will some it meeting. the at I'm core benefit primary respect yes, the submission. the an and Type to least data FDA, it it,

Jim Birchenough

the for questions. Great. Thanks taking

Mark E. Pruzanski

Jim. Thanks,

Operator

Thank you.

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

line Your is open.

Salveen Richter

reframing Hi. Thanks what little What Good taking you you look initially elaborate by really you does profile? presented benefit the risk versus question. to mean Can further agency? on like a it that for morning. the how bit the just

Mark E. Pruzanski

data of based about the treatment of focusing effects. question benefit an the I pathologist underestimation a an complete that ago Letter as appreciation and questions in I magnitude submitted couple really of how mentioned the appreciation to Well, on of variability it's of Response it's was and review recent impact gave that leads not of of and mean, of the data. a XX on June our clear the developments on Complete example, we there belief

who so quite And also reframing safety of disease this identify can (XX:XX:XX) straightforwardly really help patients, just this to should is part how then patients and additional way of frankly clinicians of benefit, appropriate pointing advanced excluded. the more treatment really the and the new with clarifying that quite magnitude work for we're be of versus proud straightforwardly clarifying is

together chance really data it totality review the it's which to bringing had that yet. the (XX:XX:XX) includes [Technical So Difficulty] reframing way and incorporating of in a

Salveen Richter

Great thank you.

Mark E. Pruzanski

Thanks.

Operator

you. Thank

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

Your line is open.

Alan Carr

more expect on which thanks and taking get? a that can stand you in penetration Europe Hi, you and where my US the detail where your latest do little review, for give on estimates a and this us the market, year? think is what's decision in questions. PBC Can things And European you in the Thanks. you

Mark E. Pruzanski

second. the hand it part for and answer to I'll first Sure. the Jerry

do track. guided my at in to year to review not I a penetration, before in remarks, revenues earlier so this January, you review. remains going we've it's approval Well, just or That take it if Europe the Europe, Jerry, completion in With started we're year. of on we an mentioned respect could review. as that. obviously But Alan expect really be stage So as in prepared next in

Jerome B. Durso

Jerry. It's Alan. Thanks, Yeah.

both We US for Europe. potential market believe in to has and continue to that and good in the PBC us see the remaining access

be we out first guidance COVID, Ocaliva us and I with think experience half obviously as that appropriate the to indication, out continues to posted the there prescribing it's more there if an you time look disruption individual for the need that. growth, at despite the have sales over the to be in in indicator patients that's physicians the the therapy they leads that there identified confidence within gain that

patients. more are there So

to have the to opportunity. in as I next think continue CRL going with to again PBC us feel and to still we refocus into really we the is opportunity back significant a allow now move we to the commercially period PBC opportunity grow

Alan Carr

Okay. Thank taking you my for questions.

Operator

Thank you.

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

open. is Your line

Jack Allen

outcomes data unblinded plan to you aspect Has with some a there REGENERATE. in Brian. seen and on data a to of share if resubmission? update know from you Jack This from you. data wondering potential And an guess abstract. you that I of any Have us is give plan the I you. any Thank that Thank that But any data new little FDA to was Hi. for REGENERATE I is long-term data would FDA use respect an on with the basis? the EASL that unblinded? mentioned for you dialing also seen to set bit could that you

Mark E. Pruzanski

study. on target for the a and time the in outcomes XXX call, questions. earlier is Thanks mean outcomes to based to REGENERATE currently data I way, remain for completion as blinded – the as view will we data the the until possible Yeah. not prior mentioned outcomes that's I along to could we And data approved events agency un-blinding. an to that with planned. agency currently (XX:XX:XX) provisions the blinded No, event the agency its ongoing theoretically powered but It is and make the of not both planned,

Jack Allen

much. so you Thank Awesome.

Mark E. Pruzanski

Thanks.

Operator

you. Thank

from the Our next line America. from Bank comes or question Meacham of Geoff of comment

Your open. line is

Aspen Mori

on into the latest move your Aspen Does how our of and first be competitive X of Ocaliva on for to force. to your – phase? guidance, Thank for NASH, the from Geoff. then, taking away thoughts on in you. strategic guess, it's goes? on OpEx that I align revenue are landscape starting I'd some today's Type Phase on or depending A do PBC, guys, questions. FDA get competitors guidance, on speak Hey any up thoughts already that updates PBC that a of And with the given quickly to redeploy love meeting shift field any maybe Thanks lowered NASH

Mark E. Pruzanski

could no and whatsoever pivot Yeah. answer from is answer the of I'll or Jerry (XX:XX:XX). NASH. But sort strategic maybe Sandip short There's no.

on first in OCA back preparing the drug. and getting NASH my delay very, right approval. being now prudent very in getting to start NASH track of is Type patients meeting agency with for A and process focused our NDA on this that get NASH the to ever prepared the to just remarks are But as call, are we throughout I We the we NASH given face mentioned

not as the on really back of – prudent mean, pivot a competitive get – a go rather the in but the major four there's things market. has away landscape. shift. I'll announcements read track been Ocaliva side again So mean to into pruning with now we should today's a years no back I application. NASH while investments you PBC I

You can that grow. business see the to continues

position in We and multiple have line second an in entrenched countries.

in continue mind, We generate also, data. keep to

data label six-year X our one a durable have go Phase communicate So trial. is of reinitiated abstracts clearance the EASL to coming X COBALT up long-term open our of in and for. enrollment we're market preparing which Phase we actually And from trial. the efficacy data We at POISE safety just five-year now outcomes

value we may or – dose long-term developing combination are data course, remain combination the PBC products not we far reason we next competing we of few of lifecycle of to And ahead And, with that bezafibrate. to may fixed OCA in irrespective years, or to limited continue we OCA. believe presented come committed have So, market. a the respect with supportive bezafibrate will based supporting a meetings believe of we responsive with to the And competitive on very, data, have of urso. remain far datasets so in that clinical been that to looking different on on know very available at with scientific of its at bezafibrate and patients OCA in also will strongly urso own combo but not reassuring you the

Aspen Mori

Thank you.

Mark E. Pruzanski

add investments. don't if know refocusing about Sandip, have anything to I Jerry, you

Jerome B. Durso

to as the the scientific is of obviously just will efforts No. PBC I at center on continue to suggested Mark won't that change. maybe guess point refocus NASH that, one opportunity with now the be other conversation commercial the

have a do pivot quickly to I think well as education order in as things of and already remarks, we'll the we and a that right we our it's is will terms that have lasting that the to market. final forward effect. be really And back underway efforts progress prepared of And obviously path I strongly our when huge the the better have appropriate. said understanding positioned in learned point believe a as taken amount in we've in

Operator

Thank you.

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

line Your is open.

Steven Seedhouse

and down because just for on selection pretty morning. drill taking benefit, rationale to question. subsets, fibrosis of the my bridging discussion patient more Good I et focusing cetera. Mark risk fibrosis, the the for have highlighted Thanks you on nicely

cetera. potential You the focus course, of risk didn't is mention the narrowing statins, really equation on highest patients ostensibly side which, of diabetics, on in the et

versus helpful? co-morbidities respect part to in the of what originally initial regulatory with be narrowing label Thank you intended, So clarify, maybe fact, that'd you. strategy could the is, you

Mark E. Pruzanski

the for Thanks Yeah. question.

Phase year. patients is which who cirrhotic. a of step by population, the are populations, enrolled with we have distinct milligrams back view X next that NASH there then way you So as there to the kind expected developed just isn't opened they're But the compensated already the cirrhosis OCA let FDA not are the read incent. XX EMA and in And fibrosis fully and REVERSE with separate XX yet cirrhosis that's of me NASH a But studying point and patients NASH IND. end two that know, patients out trial and broader under that have a who out take

that is initial so developing us focus for drug an what that anyone population. a means NASH that with and define on And will for NASH fibrosis the

significant of stepped And declining on some the cirrhotics risk risk so side really on significantly of exclusively well, hepatic view our a portal side in hepatic it, amount the hypertension. the risk up are reserve of particularly, and/or obviously on evidence impairment clinically cirrhotics of with equation,

don't response We've the statin combination with in indicated true us in with who That's complete managing use will of risk that initial about these data also part patients to greater and and in at for focus not actually to in to anyone effectively such statins that diabetics the I LDL. we use your that's talking talk population And showing and patients the can the And guidelines manage We who safely saw generate of question, I'm and of follows respect identifying and true exclude really therapy. on for so at a OCA for the to effective identifying use be lot safe least patients long NASH is dyslipidemic a fibrosis be initial But us. benefit and population. when to about and appropriate with and maintained treatment intend. non-diabetics. treatment, are no, we AASLD from patients EASL who risk this

Steven Seedhouse

you. Great. Thank

Mark E. Pruzanski

Thanks.

Operator

Thank you.

of comment or UBS. question next Our the from Jacob comes line from Navin

Your is open. line

Unknown Speaker

you Thank our if for the guidance. behind new questions. team. ask first Hi, taking (XX:XX:XX) pulls Two may. to I and pushes ones on I quick this is Jonathan Navin. wanted for about This OpEx

should that sense our of versus a could SG&A? give between us we would how going think forward. you R&D pricing then just And second question $XXX If be million how about shakes up

Mark E. Pruzanski

Sandip?

Sandip S. Kapadia

Yeah, for question. hi, it's Thanks Sandip. the

to I I take today I across context we're letter discontinuing we're having With further did a investments, contract our little by an sales as as down give force, update think on expenses of looking a range prelaunch pulling regard plan that the mean much allowed about speak million. to what place well. very to operating $XXX on mean our us focused which in well the bit since I of mean our Jerry on as back at the NASH rest expense organization

call you want really can't if execute at you assure on I and to But provide it plans. you like as break stage. to future this our a So continue that our we assess we continue I investments out prudent can we'll update be as

Operator

you. Thank

of Michael question line will from the next or come Morabito. Our comment

Your is open. line

Michael V. Morabito

the Thank you as the team guidelines for more FDA. viewed to than ask generally slightly EMA for you, are I the difficult wanted taking questions.

more there so, outcome? how a And the with is positive submission that you your what that you would EMA, about CRL submission going the gives have hope process considering you that and expect regulatory and

Mark E. Pruzanski

constructive worsening of two the need a referring no out, also And does that that that guess to fibrosis now. primarily the are an interact of have a of time equivalent demonstration out basis our fibrosis approach. benefit like one primary suggest be stage feel and agencies would drugs views of a which a OCA of proceed the to be for there and totality of through to in have guidance is efficacy we I that NASH EMA then, of on based the and they Yeah. while with the you're specifically liver demonstrated. basis over we anti-fibrotic Well, drugs resolution, the I continue reflection our of things long that to I MAA certainly, we've think for in forum also with another to improvement. year-and-half review fibrosis fibrosis ago that There's and the REGENERATE, on point that of fibrosis NASH which as it's general maybe NASH maintained provision harmonization improvement draft development to came and paper data EMA. support the both with no will true the on convincing two we with continuing endpoints worsening that with submission NASH for and exchange opportunity And to have

their the US our is Difficulty] – would review be the hope and the XX true of own. the expect we EMA, (XX:XX:XX we fact independent [Technical course, month course, data their as side, in agency NDA generated know XX:XX:XX) And, support on You is that of an to of regulatory will that

Michael V. Morabito

Thanks, Mark.

Operator

for this like to turn Thank I remarks. Q&A over any time, to the would you. need At will the end conference Pruzanski closing back to session. Dr. we

Mark E. Pruzanski

– operator. upcoming At for focused time, time side. to the need. guidance Thanks range, we it. we on very of steps course, as our as an by period meeting with resubmit capital, we delay of comprehensively same a are Type to we position the on taken (XX:XX:XX OpEx possible appropriate get we've the Difficulty] back getting shareholder $XXX so million NASH XX:XX:XX) step our toward and the on constructive in what as terms Yeah. stewards review US be hope will for the as navigate very, preserve We've the expeditiously back And, respect [Technical responsible of PBC in A highly in capital in extended of been preparing NASH. track exchange to that

we our on KOL need at patient with NASH patients are expeditiously possible. from backs, in it's the wind to have who [Technical We gets fibrosis behalf passionate and have as Difficulty] that advocates the from advanced community (XX:XX:XX) support our and OCA as

the in So Thanks update. NASH, look patients. way much behalf non-viral in on disease providing continue will in next very our of forward and leading to progressive we PBC, liver

Operator

participating you the Ladies and This gentlemen, thank concludes conference. for in today's program.

disconnect. have day. now a wonderful may Everyone You

Intercept Pharmaceuticals (ICPT) 10 Aug 202020 Q2 Earnings call transcript