ICPT - Earnings call transcript Q4 2019 | Intercept Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Intercept Fourth Quarter and Full Year Earnings Conference Call. [Operator Instructions] I would now like to do introduce your host for today's conference call, Ms. Lisa DeFrancesco, Head of Investor Relations.

You may begin.

Lisa DeFrancesco

Thank you. thank joining and call. on everyone morning, you us for today's Good and slides, morning, release website XXXX full results, press issued at financial posted our and This a and www.interceptpharma.com. announcing we on are which available fourth quarter position also our accompanying year

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

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

Sandip allow then yourself initial Dr. the Pruzanski; our Operating all and your in Chief to call take Financial to our Durso; be for will prepared from questions limit Kapadia. order those question Please open Today's followed Officer, addressed. by our We'll with to one to from Officer, Mark time begin call questions. remarks Jerry CEO, Chief

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

Mark Pruzanski

the a fourth pioneer exciting very due and good past consider everyone. full of our as you for earnings first the our quarter as I'm over Intercept call. to Thanks, the the achievements great for fibrosis leading of advanced proud treatment us on we NASH. joining a on next footing, liver with Lisa, and foundational conference Thank XXXX development and year, patients chapter XXXX for and putting us morning, year

the to first pivotal only Phase begin have year, Recapping so I far, the NASH and, with X successful readout.

in fibrosis OCA-treated results of to only large imaging XX-month for predominant to time imaging range two investigational up NITs the robust to was have earliest scientific REGENERATE the serum FibroScan with well use assess reverse month by Our the to in analysis. of the This and additional tests, interim Still XX had reporting years that interim NITs, on beyond given And REGENERATE staging, based commonly three of ability confirm OCA. was trials. change on NASH meaningful fibrosis patients, who demonstrating our the practice improvements impactful. correlate or capped fibrosis in at used highly recruited been our our study efficacy drug of clinical the fibrosis demonstrated recent liver anti-fibrotic in a well-controlled non-invasive presentation

for XXXX EMA, now by in Of half first X within half launch review Phase this our in course, under of the submission potential the This of by the us the Europe. set year. with putting launch MAA a the approval NDA under our is results and first anticipated by for review now followed stage FDA position priority our

extension Ocaliva growth sales, countries, now in access in XX to demonstrating deliver report representing study X safety gratifying five-plus-year XX,XXX treatment and while finish with And globally expand efficacy million open-label exceeding XX% to in PBC our exceptional years population. need. guidance. durable, PBC continued over in net XXXX, of we experience year approved strong PBC the in of also data and in at We completed our prior was top the recording patients continue in to the for $XXX it business patient Phase end results our a With

Of of our combination we PBC Phase bezafibrate portfolio, study product to the progress view with OCA on combination. of in of a enhancing we innovation. formulation making a initiated the And long-term continue course, and X drive good fixed-dose while

Finally, we Company's heading financing our a balance $XXX solidify [indiscernible] shored a million up the year. to into position with launch sheet financial

continue NASH we With to clinical we completed year phase, treatment enrollment commercial next the in in the our Early patients operational future. our our the REVERSE strong of as advanced more in quarter momentum have XXXX, study groundbreaking maintained on and build of foundation the Year, Phase important, compensated cirrhosis. As blinded to expect XXX patient by REVERSE read embark for of this into end we first we on in New sub-segment patients with NASH population. the X an XX-month out we

our In fibrosis review lead the in patients of anticipated regulatory pieces up the to NASH. approval preparatory of commercial all in due meantime, of place for focus FDA and are launch and advanced on with we OCA as simultaneously treatment efforts to the the

consider and truly While pharmacologic advancing decade the patients to of two of first the finally done, and who journey of to premature almost much to bringing are remains failure at discovery be liver development option cusp death. that risk are effective on it's after gratifying to cirrhosis, we a these

regulatory to Jerry, detail the more over hand we the I'd in where I like Before in to review review little process. are call a

action are confident June meeting a undertaking is planning to April and ADCOM, date, well prepared. date an tentative we that an you announced hold FDA or know, Planning as First, and of ADCOM PDUFA major Advisory XX. an previously be we will we committee, XX with for a is updated target

effectively benefit successful to ADCOM demonstrate able for of be our We with proposition we been job a one preceding wide has the prior upcoming. and approval positive an of experts, OCA's confident for range will our the team prepare experience to risk. have our continue PBC we external excellent value strong and doing Engaging that patients be to

not breakthrough and safety we often in shortcuts program efficacy did data NASH great profile extensive say, taking in have drug's any and a development assembled designated our supporting fibrosis. I amount of As our

With PBC Jerry? an provide activities. and update global on that, Jerry commercial business our now NASH will prelaunch

Jerry Durso

and Mark, morning, PBC everyone. commercial performance. solid in our was good of a year XXXX terms Thanks,

Ocaliva and $XXX.X patients the year, prior million Ocaliva full XX% we we In globally, the continue in more to the PBC of and For sales the as net reported year bring Ocaliva quarter over of which to was help prescribers US quarterly abroad. end-market growth benefits more demand sales community-based in GI million as sales $XX.X reflecting highest reported we million US, of achieved fourth quarter, gained in growth specialists with consistent Ocaliva. we $XX.X sales, four, net net worldwide the date. In experience our to the

in And We to international a trend we up point, sales the Ocaliva of year. saw turning sales Now, global entire region. US the in sales. fourth the our XX% ex-US quarter. our reflected strong of growth This the our key This net performance $XX.X about throughout Ocaliva million at continued net make net international was achieved the markets. this outside

commercial We've want identified hepatologist update fibrosis focus launch initial advanced we due are patients some a to and I target to under This our a with great today population for talking without the course, PBC, NASH in in need on of to as our about in progress to population estimated and and patients where you cirrhosis due we're investor advanced US. already teams approximately for OCA. those the critical our XXX,XXX a the our of how these our on on time unmet represents resources. launch. spent of fibrosis addition care of we who for Of specialist. our event significant our Today, that will which it as a gastroenterologists, disease, consists deal NASH is are patients initiatives. continue December, make launch we care believe the we of focus preparations Again, At plans launch progressing under NASH to our

that customer and organization We the for work, team approval track continue preparation our of and education completed profiling We've on on expanded able force majority practice identify a focused the patients launch of up on currently sales measures out. said plans commercial a launch. we've without majority leadership, surveyed strong of laid at be NASH often using date, targeting advanced assess to conducting and for the disease Based employed we're who research, manage liver the to to gastroenterologist and we'll hiring reliably that they're previously market launch and The and our we our field-based flex non-invasive with hepatologist non-invasively. are biopsy. specialists and in fibrosis

physicians efforts we as making through encourage that to tools use continue access our to. they We're the to have non-invasive disease progress education good

country's know CBC. the our in automatic our is along patient's to quarter CPT diagnostic came FIB-X to a efforts of example of see with codes to congresses addition face with We calculation when a the area in and new good from disease this that of and focus momentum trigger momentum our score liver engagement disease education HCPs, to their also the education We've recent critical recent stakeholders. continue area. this normal and established earlier like productive efforts face we NASH companies, category One had one that other LabCorp, in the panel of meetings. this it's In new work, leading

the about very Our learning been have has of efforts educational gastroenterologists the taking teams, particularly physician education, our NASH. force reached focused now X,XXX field into in medical solely already months about for and been over on that six year we account last specialists. team with When we in was expanded field more field who estimate interested

and patients. During cirrhosis on for fibrosis interactions, patient space, managing of importance these and risk increased focuses identifying that appropriately the these our education advanced the

are discussions as with launch as closer in NASH. would been with for in we payers prepare launch, expect, move interactions to increasing. our And you We've payers as we the

making the is both the And sides with of market Our say I team level payers in across country. is can that, access progress high. speaking engagement strong key on

fibrosis work surprises. be the journey bring that months on have the and to to of target due payers remains will understanding to the our goal population continue very patient a remain advanced key no a they NASH and Our encouraged. that we there clear ensure This focus ahead of are to and in

reminder, will be to launch our first launch. six the a months. a We're nine NASH specialty in As in

expect is which be followed We typical by to of This then commercial to longer. on bit building government reimbursement expected see a side. the access usually takes the the reimbursement,

efforts. very So our with across pleased I'm board, the

us advanced be and market should first NASH. launch, fibrosis of this choice positioned in for OCA patients tells due knowledge only in-depth well the treatment that to Our be to upon with

launch on to the first this is patients NASH. for to advanced suffering preparation access due Our fibrosis category track and provide execute in OCA from to

I'll Kapadia update. our Chief Sandip turn the now, And for over Officer, a Sandip? financial Financial call to

Sandip Kapadia

ended and December full results this morning our morning, earlier Jerry, Thank issued release for XXXX. a press to year financial XX, everyone. and for the quarter our of good you, Please full refer summary

in $XXX sales Our business Ocaliva at well high NASH in a year the We million $XX.X with launch invested we recognized end the resources gross our XXXX. activity, of net fourth in with quarter-to-date, also closed highest balance performed proceeds fourth of range. sheet very total million from In successful the XXXX. from while revenue, the preparation strengthening in our the quarter quarter, incremental $XX.X guidance We up our million in financing.

representing For million, growth $XXX the full prior year year. the XX% XXXX, of over total were revenues a

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

for move growth, the end communicated our see into we prescription Ocaliva XX% fourth demand previously we to quarter the continue expect XX% were solid gross-to-net towards range. lower as to which XXXX. of to Total We continue

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

million our full the GAAP and $XXX.X expenses were year operating adjusted $XXX.X For expenses XXXX, non-GAAP million. were operating

expenses our a As costs. depreciation operating excludes non-GAAP non-cash adjusted compensation, and reminder, operating lease stock-based

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

general year preparation related the and launch were million activity. was fourth expenses over primarily for increases $XX.X NASH of the to administrative $XX.X an quarter quarter and our million. selling, Our driven This by prior increase was

force, the the exception support completed we with QX. the QX, NASH field to the complete [indiscernible] majority to of in which up the we anticipate of During build launch

and Our research for was quarter the prior and quarter. generally in line development $XX.X expenses fourth with million year

cash As for equivalents, investable of securities debt million. of $XXX.X we approximately available December cash, had and cash XX, restricted sale XXXX,

the financial year. our to Turning for guidance

potential this our in As our due impact uncertainties XXXX guidance. OCA in you saw their fibrosis NASH financial net of sales to relating morning, our to release XXXX of not liver we're performance, launch a and providing as result on earnings

and and Ocaliva demand growth year-over-year continued to sales to We in half expect growth. of the first XXXX perform continue reflect solid well,

you that reset. XXXX remind insurance seasonality, plans US like do first In the I'd we the of expect terms quarter of to as softness in in

in increase by the are expecting for again We coverage the manufacturers' QX responsibility is gap. which impacted gross-to-net, typical

efforts With $XXX the expenses to to operating to our $XXX the in expenses, of adjusted million, due be non-GAAP respect range for reflecting investments on PBC, OCA commercial XXXX continuation June launch operating we our or date about of action for and expect development and our in to PDUFA OCA approval assumes support liver pipeline million to fibrosis programs This of guidance expenses. XX, other and NASH, clinical of expense XXXX. the

to fibrosis summary, to bring in on business ended in on XXXX patients while first we positioned the achieve NASH. objectives We and to In in momentum liver the saw focusing capitalize our commercial XXXX therapy approved with plan due well to strategic milestones that to our regulatory PBC XXXX. we

expense SEC financial adjusted explanation Please a refer non-GAAP this is our press morning as of a regulation. earlier for reminder, Finally, and this full to measure. operating release under non-GAAP measure reconciliation a issued

now the operator. I'd call to over like Operator? to the turn

Operator

Our from Instructions] Abrahams with RBC comes [Operator Markets. question Brian first Capital

Brian Abrahams

interactions latest Thanks any commercial taking pricing, access, very on down any receiving different now structured, maybe Thanks. much if differently diagnostics? bit the payers. expect It how feedback amongst and perceptions you're non-invasive views on to wondering, my on indications right I you that points a overall the question having pressure for you price to be curious you increasing to all with payers your little potential in drill the on that reimbursement congratulations learn sounds could progress. more; on and like are was for

Mark Pruzanski

Thanks, ask that. I'll take Brian. to Jerry

Jerry Durso

question, we the progress the focused as with the and heavily Brian. to remarks, for said the prepared payers, Obviously, closer Thanks you imagine, can our I in we're launch as interactions as think influencers different with to and of in more departments the both national the payers. group payers the conversations a you construction speaking frankly the payers, about of we're broad frequent get on across when

continues direction. progress our to go right in the think, I

I think highest ones the likelihood that the have is focused patients that the the largest which both progress population the payers cirrhosis, are the the a because advanced costs. discussion complications on of payers have that's continues acknowledge where, -- concern to and to be who to

So, we've a seen good progressive discussion.

we'll rest expect these you, look at how be price would the point, along in there forward with progress a approval elements, list and a was overall are we to these we've we -- at payer patient and better depending final discussion, we NASH back our to would on the PBC. different of on prepared, of as course the with of a I payers would think a there in understanding part population, which target ultimately able on that discussions at our forward points as the continued to including the come portfolio and communicating price some with finalization we then of discussions on now and be to label, -- approach time on move anticipate the with discussion are progress the of that

Brian Abrahams

Thanks, Jerry.

Operator

comes Cantor Young Fitzgerald. with from next Alethia Our question

Alethia Young

just talk all and and you taking and kind same obviously, at diseases on the are panel heading versus can that the for what answer but compare the two Maybe this question. drug? are maybe they of to expectations PBC you my into how what X.X, the Thanks how questions contrast Thanks. -- different panel happened for you And what prepared this them. progress. anticipate you biggest panel, Congrats

Mark Pruzanski

Alethia. Thanks, Yes.

in for So, of remarks, panel. well this my as preparations we're I in mentioned prepared underway terms

I very least category. have first at this we One that I outcome, think successful mentioned is in experience difference from a is, a two-fold. the with new drug do as PBC, and is

disease bigger sicker, are with patients fibrosis NASH is obviously generally targeting They the and we're advanced that frankly multiple much co-morbidities. typically right. have Second, a

disciplines, we're say NASH actively So, with preparing consulting the I we experts would more of across are broadly, range patient. typical a matching

in risk I that's required to think this benefit for. what panel spans is typically we're FDA of puts of any and look, surprises what what a no of inform here drug, preparing to range the like assessment

Alethia Young

thanks. Great,

Mark Pruzanski

Thanks, Alethia.

Operator

comes from Michael question with next Our Yee Jefferies.

Michael Yee

discussion to the you all been going not to these conversations conviction how have think payers prepared for around you're or those question. of from think underway about about again, just about comments, your your thanks would guys, that again any back how with Hey overall ask some guess concerns In biopsy level payers? the and to thing that about strategies, in we pricing you payers gets I you that the and about is, how requirements hearing launch that And is that then your learn that, that. for codes, that as wanted discussion thing, know FDA NDC be how just so I codes, so an bit you NDC explain communicate you're said some a would and understand two approved. needs NASH works, have just a different we that different that to is payer to little once much. would maybe Is Thank different two can follow-up two

Mark Pruzanski

I'll Mike. hand to Thanks, that Jerry.

Jerry Durso

for thanks Mike. second guess, one the I'll Yes, the first. take I questions,

optionality goal on able two out for our successful. to has different our So, brands maintain price points been if we're be to there potentially

how would, a code filed brand, approved, the the us label, have NDC to separate separate We brand. of which we if a which have option PBC give a separate price would NDA, then vis-a-vis a separate

give I our an with get a be pricing we'll strategy PBC. a and payers the that as pricing a decision you to based and and felt in ultimately that back and of we once time, regulatory with would then the come on on decision to label factor was the what there at our So, we take indicator NASH discussion best said, future on thinking

proactively been we're non-invasives and targeting patients openly I the fibrosis think the The side. probably could experience been that situation, surprising has identify course, objectives conditions collaboration, that where adopted, discussion of been, part other best and biopsy liver the the engage did of we you of going payers, become payers of different not with advanced talking to has based it's aware, the as we're we're with good that see from their from payers. a how you Again, their the and them be experience, been a are payer to as look in our one discussion at to on has the with so both imagine, and payers, physician

it's while to definitive, we So, confident. little remain a early completely too be do

aware discussion with suffice and that data having are focused move and with the say, encouraged, We of the are work payers think limitations non-invasives field payers we on the with the concerns biopsy the I field remain along. the practice openly, around also along all and emerging remain of to we to of and physicians doing that in we're but

Michael Yee

Got it. Thank you.

Operator

from with Sachs. question next Richter Goldman Our comes Salveen

Ross Weinreb

taking for Thanks on Ross This for the Salveen. is question.

With then, that half here, landscape what given readout, we've REVERSE read up launch the we should trial be we this by any to the about in And during secondly, launch inventory the seen the second you X the confidence able failures you out across how be Phase will the about think guys initial period. if successfully coming current impact thinking have competitors?

Mark Pruzanski

Thanks, Ross.

So, inventory I'll to second hand then the for take question. the and over question Sandip

but they read They're enrolled as year time, of these REVERSE, the And and in we bridging of we've yet to talked I mentioned guiding proud enrolled it who with study. essentially over with varices compensated size benefit frankly development have we don't with puts of the in by in demonstrated out significant have the not study much we've early last in doubled cirrhotics, ensure yet on We've the with esophageal anti-fibrotic therefore that and of hypertension. obviously compensated my that end the very to that more we that patients So, are prepared any clinically don't of patients, period fibrosis remarks cirrhotic, patients cirrhosis patients have F-X were advanced. next that the this not XXX cirrhosis before, robust same portal the been fact year. then the

year with to actually ability in in early we out last competitor that more And the reversal and we OCA demonstrate believe us give fibrosis actually compensated of that results the reported failing cirrhosis. patient this the confidence

very year. of forward towards looking reading So, to end Sandip. much the we're out And then, next

Sandip Kapadia

the question inventory, are it's much the of in how do the assume inventory, On was more product hand thinking or Ross, how you I sell-in? the sell the or on we'll have you specific? assume, like you I meant recognize

Ross Weinreb

exactly. Yes,

going to impact? guys inventory -- be any You stocking have

Sandip Kapadia

we're a will mean make it I launch, this look, to specialty be pharmacies. Yes. Yes, so through planning specialty

typically there obviously it's So, launch. a be but will some, generally than less much broader

on initially, specialty that but that's some I but yes, sold doing too it given of I we're depend not probably wholesalers. it's pharmacy be will probably that say timing think obviously in inventory would So there'll launch, fact the a and be will rather minimal, large the the

Ross Weinreb

it. Got Thanks, guys.

Operator

comes Partners. with Our from question Capital next Yasmeen Rahimi ROTH

Yasmeen Rahimi

on you Congrats team. continued Hi, two. my asking progress. for Two apologies and the for questions

first a little my the you guys of on for label versus just is, plan the ITT real that what do are think in versus on you these potential how The two questions. to in do non-responders might protocol, up bit And second with comfortable very then simplistic, -- terms responders decline done and how have addressing the what on request you one thank OCA the reimbursement. taking definitions, for one, world docs market we research color end

Mark Pruzanski

the hand and take I'll the one Jerry Yas. first to question turn. second Sure, in

Jerry Durso

patients an on monitoring of to terms as these at seen be that the couple be thing of monitoring seeing typical a payer Yes. year understanding on on that the a they're tends follow-up to liver that is The basis, Yasmeen. doing therapy. that I think Thanks for patients an these are discussions for are patients question, mean, are looking tends ongoing I will that who first average. there the the around times in happen, are physicians

the the the way patients been that at the are lab of real to today. with values, of and looking combination along tends world, in a managed these non-invasive part normal with So, discussion be that's payers

Mark Pruzanski

commonly who non-invasive and improvement we all treatment even and year most month scan-based the average the fibrosis XX for recently saw, know, patients XXX testing with the ongoing NITs fibrosis. fiber another Yas, We data with [ph] presented data in then, the on tuned has improvement used in And some that been in improvements study you suggesting for exciting December beyond stay as with further on Yes. correlating elastography on readout more. with

So, monitor response. real to as rigorous, use to much With efficacy for most your -- to -- was people binary the gold in the the respect first population. on we endpoint. expect world ITT primary a what approach, labeling, and standard categorical question was but the analysis in It the that's study as we've got

So, any patient get biopsy who considered didn't otherwise repeat non-responder. a dropped out or was a

sure, we efficacy So, analysis the data efficacy ITT studies supporting end profile of the more just of given course, of section in and up for to see drug. data in primary that expect totality that, of the the than clinical support hope, we'd would,

Yasmeen Rahimi

Thank you.

Operator

Our with Baral comes next Ritu Cowen. from question

Unidentified Analyst

guys, Hey for Baral. Ritu [ph] Tushan this on

two questions Just from our end.

take some diagnosis, it in treatment of track First then already of only a you through really with but up secondly, they know how include will versus to follow then it and any Thank you. on does expand the long that XXXX XX,XXX? Jerry, PBC to launch, timeline sort reach with how are was to if and comfortable for launch imaging further the response? I about the of think And just modalities color not just X,XXX is, said as scan just that NASH so, specialists, serum-based physicians, meeting like fiber or terms MRI discussing the non-invasive scores, such

Mark Pruzanski

Jerry?

Jerry Durso

Yes.

first. second take maybe So, the I'll question

context So, reminder. little a just

roughly for on currently target and calling So, X,XXX PBC, gastroenterologists. hepatologists we're

community target physicians in the launch the to issued person you NASH Our earlier can I to that will through we've week, increases target -- be of imagine that group as reside. we've designated our gastroenterologist target XX,XXX, all every reached for patients that that X,XXX as that the this in outlined we've about The education where base of broad date, of more. group launch as the we number XXX,XXX go number to number roughly goes was education

increase continue anticipate So, we would that. we'll to

that field of talked process the in we've are additional the about. forces We deploying

ultimate that so, we target And by will be we will be the launch group time the hitting that XX,XXX.

in to it is we're about reached date. point a and the variety we've different X,XXX the of progressively means think in So, that educating time

Mark Pruzanski

Yes.

Jerry Durso

then the second question… And

Mark Pruzanski

the guess, based he I serum about other question is NITs. asked

Jerry Durso

Yes.

and some to We're physicians is we of and the help there you in look, not we're been trying a the physicians picking this -- have winner of use there has So, -- to non-invasive. I But, variability, think part our and is introduced. want they feel have strategy. tools primarily the to. the some terms in are Fibroscan, based, tools have using who that do process being comfortable they tools, the FibroSure, access who using to, There including they of with some is ELF access multiple are are CRM

is the grow. of these there have and again the good they some tools us I educated, physicians continues They So, is to comfortable availability what are think variability, access are and message learn to. with for that continuing to be more and

that's market take we're going we be to see in able the of. advantage to that that we the momentum So, think

Mark Pruzanski

Yes. tests as and automatic of in is the add with potentially a remarks; FIB-Xs function relay liver there major is [indiscernible] available lot his based And that example on and forward, it's happening, also LabCorp only they're codes would Fibrosure to prepared generation step Jerry to any patient, having I doing primary mentioned thing innovation the a in of suspected patients a for many advanced CVC screen for fibrosis. of

big companies, these with also are So, be making confident time, adoption of more and lab great NITs. that more there'll and we're strides with

Unidentified Analyst

Great, you. thank

Operator

comes Seedhouse James. Our with Raymond from question Steve next

Steve Seedhouse

you. thank Hi,

find was NASH, the hoping related titration mg can with curious Thank to if Have just of respect clarify. mg a label? any I you REVERSE from -- data or even you mg X.X XX from to from OCA NDA respect for Just of to mgs, any XX your way included titration could any its to I'm to clinical including, into XX you. data studies, possibly

Mark Pruzanski

ongoing, no. I we REVERSE and to and do for arm there have blinded answer short obviously is, mean mean, I the mg titration a mg. remains XX XX

it As the demonstrated we they don't be XX reviewing will based and file the mg, the mg. we in on we for titration REGENERATE XX ultimately, But, mg had -- know, the with the XX the totality on the have you discretion mg XX efficacy there we didn't, mg. NASH FDA's XX XX between believe data, that and data of role a in we have don't on is whether side, mg,

Steve Seedhouse

Great, thank you.

Operator

UBS. Navin comes question from next with Our Jacob

Unidentified Analyst

Hi, everyone. positive This context quick landscape, on reported Thanks. NASH updated for in view [indiscernible] thoughts data a you taking just are question, in questions. for your reported competitor on given and NASH? What this Naveen, yesterday how Thanks that the data resolution. OCA fibrosis competitive do of the what

Mark Pruzanski

Yes.

whether will course study of the X challenging a forward it's talking NGM the first there, a time. term to the much so little broader long results landscape, OCA. in mentioned, of study. in The a results As they'll hope a path compared and a you're Again, just It's Phase their time competitive we'll year and show like have with injectable, very glimmer longer the of announcement benefit. path ago think yesterday, -- weren't context fibrosis think gives a line ongoing on X last X, Phase we in much larger comment about very more not a It's the with and oral a readout. positive compound, the [ph] FGFXX currently our and -- is surprising, FLINT the therapy in I this that the I it, to surprised and just do with I've daily in remains the that validated. We quick the high compound is daily forward FXR squarely as validated said results. target likely the pathway. see, result. R all-important often very, We the be bit bar The only that to Phase them was

on news impacts rest field. can't that think point, I yesterday's comment of at the this how I the

number over of couple a X. think, course we a is readouts the field very X is the year, mostly But, -- only of failures I to say that Phase expect I more the this the littered succeed. can remains as high Phase bar and say I unfortunate with and can thing --

Unidentified Analyst

Great, thanks very much.

Operator

Skorney Baird. Brian Our next question comes from with

Brian Skorney

review the we should FDA, within think of the of division directors New officially Division month, or at the under talk Division are morning for Nutrition the which OCA? level could is OCA the you will yet, I think Hey, be of Office how Office was those about on those has for the Drugs split Immunology or of if the do the question. good guys. divisions the so I named about for Hepatology this restructuring and Gastroenterology know, the we Inflammation, impact review taking new division either next of there evaluated wondering, getting high divisions? of and at Thanks and and oversees

Mark Pruzanski

Yes.

it's the broader it's and I is liver last following standalone of creation a There that what division, hepatology as think has you've this heard. is year I been that O&D but announced, we're closely. I'm of it formally heard we know that's yet is pretty part sort or of been underway, of plan. What obviously aware that not over the mentioned. we've something a reorg new

of confirmation of but Sanyal haven't pathology we that. think the has he call and that a with forward. that and division all I is mentioned recent NASH ongoing NDA named, that there division expect IND review the to Arun going disruption, hepatology for heard expect goes go do we as been our is any don't a to director the We division where

Brian Skorney

Great. there; I like one this notice in to of final get be put of a there I time should And of for could year's second have guys Will point just when not for are readout. readout you willing a -- to then, a ahead analysis point know the in maybe guidance REGENERATE, a the readout? -- as would timing you where we think of provide a guys about if wanted terms guide we

Mark Pruzanski

as at guidance. in such position the moment, you a not provide present to mentioned, we're just Well,

a REVERSE people of those development to we of outcomes the course getting segment and compound population, basis say, Needless clarity chance landscape. cirrhosis, there. have about It's at of provide out the comprising we always outcomes in important forward composite to a a events full the the following, important chance our because I a to against they of and the will on market answered as read but time, and critically on well terms has of see accumulate, are tracking in in original to to -- any blinded basis, be compounds earlier the or continue that have compensated we question position a some support endpoint at in competitive move think first-marketing tend to just better REGENERATE competing that back study to approval. phase look getting I assumptions might remember

we continue competitive time. look we market -- So, over will in positioning forward to to continuing our improve this

Brian Skorney

Mark. Great. Thanks,

Operator

Our question from with comes next Oppenheimer. Olson Jay

Jay Olson

and to OCA? or three question, out or on of market positioned seems to is efficacy since a to against you entrants and create time NASH on, defend comment, the NASH try do you last attributes for leadership your lead competitors question. a continue NASH to more longer-term taking that strategic way Thank follow later to grow. But, who over years redefine in look and threaten I therapeutics, for that uniquely Intercept maintain therapeutics, other position define the plan just in as how could you to have your may Maybe Hi.

Mark Pruzanski

Sure. difficult our period be OCA's will improve very to Well, that which a patients and do ability we'll which OCA out it foundational and will game very, continue to lead or ultimately treat disease. least, to it the in approval the the I'll a to therapy this outcomes at further to time. very of compounds and we as these upon just will just be expect follow-on We'll reprise with reading data long same changer, to the take confirming very compound comment is, position generate I to made, continue just --

also everyone this this realize. as combo and has -- much years easy about we've disease, for treatment to has the challenging to about it's seen the might regimens with the talk combination field, patients over followed talked or of think more ultimately I that emerge

PPAR just forward on hard that there. is -- see go I the hard say But We've combo interpret the assets ahead how to would always get people said the single to bar exceeding and lookout the and was let a most to about for course think, the agree US rights potential of which to promising, promising we've that extent with have opportunities. to combining OCA combine we MLAs in OCA, you the other could with readout PPAR be the just that to [ph] with high, and combos to alone was continue for let's in the past frankly, Bezafibrate most other recent monitor the that and forward, looks can constantly moving we'll certainly, talked we're

Jay Olson

you. thank Great,

Operator

question with Securities. comes Our from next Bayko Lisa JMP

Unidentified Analyst

morning, this Jon Hi, is on for [ph] good Lisa.

unblinding regarding anything to your is to use stance question protocol patients? the then, beneficial statin or a any effects the and REGENERATE, if try And potential are on there thoughts in maintain comment Just blind? on increases, current or you NASH can due what any in

Mark Pruzanski

Yes.

we've month these a out that endpoint study. a of management are as The was been that or data, year, the and recommended have manuscript, the came difference the presented patients that an statin in the and a had show who AASLD current important the we And a guidelines statins primary of saying actually patient Lancet, before added how lipid out make at said, of obviously primary at patients in last statin-naive, who remain baseline managing who trial in statin our to a So, patients patients. we were end also read they the terms effective breakdown management patients shown which not actually use and this in realizing since in means cost and We've looked for population, said statin days the FLINT on standpoint. dyslipidemia XX, from LDL of EASL

that shown we can be certainly used safely the the two we've combination and something effectively and of it's in these that advocate So, patients.

Operator

you. Thank

with question next Moussatos comes from Our Securities. Liana Wedbush

Liana Moussatos

this question. How Thank of for you the for year OpEx the is NASH my much guidance taking launch?

Sandip Kapadia

question. the for Thanks

NASH last the to suffice can is this is infrastructure to launch, overall what a Last an year, million it, of certainly we and support approval allocated our our portion the continue that action mean on launch the I the mean or had guidance we from support resources and we about you year, about I haven't provided to On say, year, OpEx PBC efforts breakdown anticipates launch. tell increased incrementally the really good we NASH reallocate to the but a I SG&A, date. launch. to guidance, NASH in $XXX terms of support But PDUFA leverage PBC obviously

Liana Moussatos

Thank you.

Operator

Our Alan next question & Carr with Company. comes from Needham

Alan Carr

thoughts be going headed, non-invasive expectations. Hi, where NASH taking versus you give might Some thanks PBC on you sales meeting of can can that, Thanks. your around think then, or your Mark, it's Jerry, questions. and how in my And details on trial comment biopsy? more whether Europe? the it's for you not endpoints us

Jerry Durso

progress very with the the Thanks, Alan. picture. international on Jerry. would say This our we've consistent I We're is Yes, across overall made positive markets.

one seen better really countries, progressed, two I markets performance think as is the elements the across that or it's you've have good that we substantially not one of consistent others. as the main things if than are the see doing

really been good it's performance. think I

the the in in importance educational markets, the think the I a PBC. of sharing so markets have the terms of learnings earlier of you've learned from efforts seen

of one have XXXX that trends progress of I Europe, our course has part think into think, the therapy the throughout of the themes overall, been in feel good as we we the that of we and second-line overall XXXX, prescribing the coming the an business about forward. level I PBC important momentum remains increase in consistent so and look and

Mark Pruzanski

at Yes, the question biopsy complex including obviously to the is endpoints, regulatory limitations meeting categorical There burning AASLD/EASL co-sponsoring endpoints upcoming, with least and future. the demonstrate from aware near hand, NASH in these as the the an authorities, I'm the on that and stakeholders, your you're hand from regulatory standpoint, a endpoints. one of see in histologic unlikely on and we're all the a on field, respect shift improvement next other to it's month. real away sure Alan requirement the to going It's histologic question where recognize

forum in field, active there's liver interest this. the is in the at ongoing So, looking

a But probably time. it's there histology on we've guidances population. I right do just now, focusing out matter of think draft this in So, got

non-invasives along as validating it's with going continue but evidence endpoints, -- So to time. everyone we, else are going driving to take for

Alan Carr

All right. for taking Thanks questions. my

Operator

next Our comes Joel Beatty with from question Citi.

Joel Beatty

question. Hi, thanks for taking the

use a of prescription of role anticipate end that will non-invasive OCA the upcoming you be AdCom, diagnostics, topic of would the or be the that outside For in AdCom? considering there the do

Sandip Kapadia

my certainly, we've support it's in could NIT-based that to FDA data of asked the presented speculation part. It But, panel a And of lot patients. be of pure identification on something consider.

Joel Beatty

Got it, thanks.

Sandip Kapadia

Thanks.

Operator

with question Leerink. comes from Our Thomas SVB next Smith

Thomas Smith

Hi guys, in thanks of in then you for the this trial at imagine NDA? the mentioned be for rationale be arm, the for supplement to you along separate indication where fibrosis dose, the REVERSE filing if to this NDA Mark Can XX and taking XX the the positive you or looking study potential talk were mgs, about a mg NASH mg cirrhotics, this the choice do titration to doses the questions. with just XX would a

Mark Pruzanski

drug to dose selection readout we see and Yes, remember tested respect the increased Remember, doses of you to for the REVERSE, our of mg mg, study dose hence prior the again to in the and selection so design cirrhotic patients, XX where we of the particularly in with expect exposure REGENERATE and XX the dose liver, right. same for

buck given your for bang more -- dose. clinical more a So, at

remind the me is, And right. NDA. part happy your -- of second doses. know, year. That's NASH testing so separate those population. of the to path true successful two towards next based the is for what a -- Yes, you and REVERSE we're in separate to under in what is forward this also of So, with readout, see the the IND, result end as and the we'll the We'll NASH separate have all the sort cirrhosis see indication. a field, expanded then is on get players FDA of with considers ongoing what population the question,

Thomas Smith

thanks. great, Okay,

Operator

turn the showing this over time, back And not any I'm our like host. questions I'd to further at call

Mark Pruzanski

our call everyone year-end morning. joining Yes, well, for thanks this

very passes, the Just and about NASH, to weeks is in us. believe to the OCA execution therapy the will each continue important patients which be much. liver due offer positioned well approved fibrosis to we drug consider everyone NASH. solely is patients become be with following the advanced to opportunity due truly months to FDA here which swiftly day a to first advanced we The anticipated that suffering from for our critically Thanks moving next blockbuster ability foundational and fibrosis at with few very approval, objective, we're for achieving the to towards to company close,

Operator

today's presentation. this gentlemen, and Ladies conclude does

and may day. You wonderful now disconnect a have

Intercept Pharmaceuticals (ICPT) 25 Feb 202019 Q4 Earnings call transcript