ICPT - Earnings call transcript Q1 2019 | Intercept Pharmaceuticals, Inc.

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Operator

Good morning ladies and gentlemen and thank you for joining the Intercept Pharmaceuticals' First Quarter 2019 Financial Results Conference Call. All participants are now in a listen-only mode.

Following the opening remarks, Intercept's Management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request and a webcast of this call will be archived on the company's website for approximately two weeks. I would now like to introduce Justine O'Malley, Vice President, Corporate Affairs. ahead. go Please

Justine O'Malley

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

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

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

addition, begin Chief indication call please In the use OCA our Kapadia. Operating for investigational time. safety call, Durso Officer, Pruzanski authority OCA with will to from questions. not Jerry and at your from take by for be approved the Mark prepared considering an Financial of note any CEO, can those this remarks we any regulatory then We'll Sandip Chief that than Today's other that Dr. product by or is our followed indication, No efficacy Officer, any other been our conclusions drawn for PBC. has open

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

Mark Pruzanski

of a Justin a and Thank you for start heralded critical the joining year, transformative number exciting Thanks call. quarter year had of milestones first beginning the to an our conference for XXXX us on good achieving We that everyone. Intercept. morning

improvement primary anti-fibrotic least OCA's endpoint robust worsening the the particularly stage and with thrilled in NASH. of most one paving to-date, disease way X fibrosis Phase met moment due NASH effect our drug approved. become this of with NASH. liver REGENERATE course, the successful study and marked XX X patients month with is study having in first of only fibrosis watershed to study XX-milligram reported generated if at that dose REGENERATE daily liver with comprehensive a the ever of readout and liver We in Of in no for Phase the indication, results pivotal for largest announcement OCA the we We're in positive the in to OCA the conducted

many the the for Liver at European of Annual As we of or Association the Meeting you additional know, the REGENERATE, presented Study from recently analysis EASL. supportive of

demonstrating the patients one table fibrosis patients We active histological, over NASH. this ameliorating pathogenic stage are drug two milligrams particularly analysis, pre-specified, in encouraged just four to OCA most analysis compared is XX the by analysis, was on The at the clear in identified that in in biopsy. of OCA across the on observed key repeat with XX fibrosis least dose nearly shift highly parameters these biochemical and response in important placebo. a improved In XX multiple by

at to XX Importantly, in one OCA the two same compared worsened stage XX XX by least on patients placebo. in milligrams approximately just analysis, as in over one on

both clinically, importance. fibrosis prevention reversal are course, of great and worsening of Of of

was endpoint not Consistent dose-dependent addition, improvements such and reflected on such was steatohepatitis activity resolution effects, biological in treatment and OCA ballooning. the based although improvement of ALT, activity primary GGT. the previously OCA sustained disease underlying in rapid overall with ameliorated the as assessment parameters, AST, met, as and drug's liver in liver NASH and pathologist's enzymes, inflammation reported key In

our abnormally in liver the double are at clinical key and how in of half by Importantly, for years discovered treatment after patients is REGENERATE baseline, benefit failures fibrosis ALT on controlled for routine the means in approved is field the trial. currently patients With a fibrosis alone of reinforces and planning year. primary And sobering additional on and projected available filing third Accordingly, tests development these clear of in the shown just we've with a about in with excitement It's with payers, and how that the NDA stage increasingly It's to treatment. from other reflect relevant kind ALT, and to imaging III MAA our and more be belief on said, than focused practice. patients physicians case normalized to spate today with launch an with to positioned challenging rate due of on phase the based the wait, activities well non-invasive diagnose a possibility that This And totality AST, anti-fibrotic competitive We has to OCA. their which enthusiastic improvement provide in on opinion become of that the the clinically quarter this this need benefit. fourth results, Jerry of and reminded patients we market desirable accelerating openly and normalized a treatment, any in generated potential essential not feature our who to and therapy. anti-fibrotic that announce drugs fibrosis enrolled to to we anti-fibrotic based NASH in of XX routine placebo And advanced approved the typically in predict fibrosis by those known received left our NASH. The most a elevated the has anti-fibrotic on fibrosis assessment. and majority it's both. our us demonstrated adverse milligram REGENERATE of fibrosis expressed demonstrated OCA, very long-standing invigorated research single is the quarter two-thirds well recent in pressing patients liver NASH. NASH shown OCA we had the the becoming phase outcomes relative a data will the broader it OCA on been AST are followed with due to blood to a community, the are bed-side this that the the unique approaching an become detail of close for Based to-date, also and demonstrate effective patients the drug that leaders benefit EASL It's address near-term NASH as to has in investigational their advanced REGENERATE pleased well position feedback; are with to have first to modalities now of are therapy filing mortality. acceleration NASH has all-cause II advantage shortly. related we

phase program well to by by over REVERSE, and end comprehensive globally. XXXX. with and study enrolling continued cirrhosis also remains to expand to-date. on enroll NASH XXXX track compensated largest study enrolled of has the the course, its patient’s well continues REGENERATE reach of and Of target current III III our our patients is NASH its with kind well to is far phase

the it's everyone focus program, that recognize our business. PBC on important With NASH our the understandable strength of

the very show with in attribute patients. this growth solid in providers Ocaliva sales marketplace at well just customer that successful strategy healthcare the as their trend first seeing expanded as our a in results million. $XX quarter of implementation the of coming growth Our are reach We results under to

patients. anti-fibrotic of things, and confidence among Ocaliva's the further long-term has been Our benefit supporting clinical presentation by data, bolstered benefits anti-inflammatory the in other therapy at PBC EASL of in

Jerry? for disease data company. bringing II liver presentation market potential Ocaliva, including a market underscore combination clearly NASH for first we the demonstration its at we've successfully turn therapeutic data study the we be focused launch and the open over its medical new publish clear our advanced our discussions blockbuster extension plan payers, NASH U.S. update and summary, five the to indications, will and to the pre-launch positioned to with mirrors treatment Ocaliva's has of PBC, the in it with label had approval. for globally. I'll the III our first and the effect Longer XXXX are announced therapy. evaluating multi-year of durable accumulating with on This safety penetration with profile. We continue followed study, critically this confidence clinical performance data for to this transformational differentiate a and patients With our and ever net fibrosis. a business and clinical on by other EASL success this efforts PBC. our we activities. initiating addition, physicians of bezafibrate first us extensive the commercial a quarter this specialty the profile with Ocaliva we've been in patients guidance, And to are we'll reflection demonstrate post-marketing of PBC in changes POISE for In treatment of rights with consistent term, our time in our from ever year phase experience setting at Jerry following pursuing built, NASH. on we've of the liver sales phase successfully in working we In population. by of given quarter, opportunity. and global increasing truly we previously in benefit deepen acquisition soon XXXX and combination our that, commercial ongoing combination treatment the patient PBC a in a Based fixed-dose The further first NASH to therapy to develop of in important by the disease seen, an confident to infrastructure liver Based be is anti-fibrotic in is no are well thousands

Jerry Durso

Thanks, everyone. good Mark, morning and

coming Ocaliva As we of mentioned, one, we million net In the worldwide represents as the community our deployed from had over last over Mark million the $XX.X growth quarter based a strategy net force achieved of XX% growth This sales sales. first majority $XX quarters. reporting in U.S., gastroenterologist quarter. we've quarter strong we result sales one direct of Internationally, XXXX. million $XX.X with the quarter achieved several first sales of a in net of the

in well, growth is indicator is now targeted pricing reimbursement international we clear of As markets, most the launch with national physicians. a major progressing our our the and that seeing we're have

our our overall see international picture. contribute business to to meaningfully continue sales We

Our strong execute shows business. our in increase as our our the net XXXX PBC confidence by to evidenced guidance, Ocaliva drive ability start sales our to in announced and momentum to continue our to year,

closer market and move turning potential fibrosis due busy time exciting OCA as NASH. bringing for Now NASH. we the patients to approval with to product to clearly to and many of It's our an advanced the

with accelerating filing consistent, we're updated the our we QX file our As the in our MAA, in Europe, timeline Mark U.S. mentioned, expect launch In to continue to quarter. preparations fourth

potential evaluating look patients associated fibrosis remain both that physicians with treatments priority payers, with avoiding the at reversing and complications cirrhosis the top we know market, new and we for NASH. As when of

at a While the the months. result diseases only of damage long-term XX study, REGENERATE is the liver underlying demonstrated usually NASH fibrosis patients Phase presents very the on OCA the our EASL medical data, stakeholders our key our REGENERATE value received, reinforced to strong positive feedback, was recently at announced this since have and OCA colleagues a proposition the meeting. in impact Based ability fibrotic in to to we X

REGENERATE mentioned, Mark data this As our among of and gastroenterologists, the the was well particularly presentation who hepatologist received meeting. attended

and improvement pulse impact at product for anecdotal their survey first who fibrosis showed addition gastroenterologists XXX the top on U.S. that In prescribe. conducted survey and strong to of had a surveyed we based OCA The it a also physicians the a is benefit seen hepatologist blinded we were feedback received to most to as profile. pulse EASL, exposed willingness

Secondly, approval and of physicians blinded patients profile, the in the clear post fibrosis. to first most NASH when adopt surveyed year with shown frequently advanced product within their the OCA prescribe majority expect the it

Of detailed prescribe need, patients. will positive an their a research about course, profile of follow. excited OCA willingness pulse high the and the supports in was the which the and based on importance benefit shown fibrosis drug REGENERATE to physicians unmet NASH the response, survey of more initial the We're the to

believe in our NASH physicians under are due development. for the approval patients targeted believe that specialists patients in medical unlock presents care a treating OCA's of to OCA's effectively following REGENERATE focused to and on position to our disease blockbuster specialist the Moving fibrosis in plans, clearly due benefit opportunity US, ongoing confident advanced the education a in with that following we'll and and approval hepatologists on ability discuss fibrosis affairs unique have understand NASH. to group are OCA's currently gastroenterologists reach readiness majority be with well that we're NASH. given compounds help convinced through with the launch remain on Currently fibrosis to state NASH that we be later-stage launch opportunity We to positioned diagnosed potential of and fibrosis. the advanced differentiated of a from other focused seen needs advanced the clear will our We we teams patients

As cirrhosis executed well severe leaders as has the complications in the numerous reaching top urgency required the to team prevent field. of thought patients. these programs in The

patients. a on non-invasive broader diagnose In to on with the focused of to cirrhosis. has and reminding hepatology maybe also addition, disease or and education importance physician NITs point GI a team the NASH rolling patients due physicians on that developing physicians the medical to We're tipping out educating increasing fibrosis been of affairs audience, tests manage advanced NASH campaign

and Additionally, has making We're REGENERATE readout. ongoing market and good our accelerated activities. our progress the medical commercial positive also in data hiring post access is

to We're market and a a of competitive dozens with in position. NITs to commercial the confident reinforced OCA's trial important need. late-stage that Our us only greatest about approval, OCA of strong access payers first effect launch they investor interactions sharing key medication of a for and be as and Chief driver Sandip the preparations our shown disease the OCA related fact teams financial move continuing look identification and NASH therefore conducted with payers fibrosis our to And advanced agree diagnosis. the to update. community, is more tend toward key now, I'll on is the value forward These launch. and we patients the payer forward Officer, our patient state. Financial have and Sandip? and the part market in have value puts commercial to and other opportunity feel NASH good already meetings which for proposition, will for have and unmet the details our Payers focused in be an with turn and our We to to subject a strategy the interactions also call cirrhosis approval that an complications prevention that have this state over Kapadia, anti-fibrotic NASH. that to of we very expect evolving be efforts clinical will and unique the recognize with the

Sandip Kapadia

and sales foundation journey REGENERATE morning our March summary out in ahead. for ended We progress of us our We in year our very results We financial announcing pre-launch and balance quarter to built for strong efforts. an important quarter. for results with read was XXXX of results had our in earlier important Phase updates NASH issued quarter important of solid QX first made our Please today for previously XXXX, study the XXXX. preparation were everyone. Jerry the XXXX, press up versus guidance. and quarter total the our a confidence release and a quarter growth our first from refer in in the NASH financial for strong PBC you, recognized X good We announced million the the very it the quarter the us of $XX million the a in gives $XX.X This in positive versus business. in XX% XX, quarter. prior-year filing to revenues first year of we're prior Thank as pleased growth pivotal

comprised Our a $XX.X $XX and were million first growth ex-U.S. million, sales of this sales and quarter of net approximately of Ocaliva quarter XX% prior-year the versus in ex-U.S. of sales XXX% U.S. U.S. net net approximately represents

the expect, range. communicated and the for primarily gross-to-net our Medicare quarter total coverage Part the of annual As deductibles related previously we XX% This higher the was resetting to deductions toward increase were the D XX% of to gross-to-net gap. end

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

a our stock-based amortization. adjusted operating reminder, and expenses and non-GAAP As exclude depreciation compensation

million material an consist quarter million. packaging, of sales the Our of sales the Costs over for $X.X of $X.X and year cost labeling, prior expenses. This related primarily first was quarter. of was increase

to first $XX.X year million quarter Our selling, increase were our an over pre-launch NASH general and by an administrative driven primarily expenses related This prior $XX.X the was period, activities. for the million. of increase

expenses, quarter. program million. over driven of NASH the increases the expenses quarter. in was first in by year million with development were and cost our increase associated the quarter the for REGENERATE The including OCA first prior development research readout primarily increase This Our $XX.X $X.X and was an

our relates to it position. as cash Now,

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

onto financial our to NDA efforts Moving XXXX, momentum XXXX build filing for and a be to as our resources support critical PBC our business guidance year NASH continues deploying activity. in while we pre-launch

net first guidance million, we year to XX% for to Given Ocaliva XXXX, and are our Ocaliva $XXX sales net of XXXX net to increasing in our sales expect for the XX% to strong confidence be range. range remainder the quarter million and gross the $XXX outlook in our to the

NASH focused leverage pre-launch increasing continue to and order with disciplined by a our investments take in to our competitive efforts. resourcing in We our unique approach position

invest to clinical continue million. will NASH filing our $XXX launch opportunity the of NASH to non-GAAP We updating execution light million $XXX NDA significant of and and market in the and program. our also In adjusted optimize development NASH we're in preparation acceleration guidance XXXX operating between expense activities, our

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

So, with that, questions. any the over to I'd operator turn Operator? like it to for

Operator

line the from from comes question Yee Michael first of Our Instruction] [Operator Jefferies.

please. question, Your

Michael Yee

good Thanks I Two looking ways as guess for that key presented, anything various prevention the other morning. cirrhosis, to but Hey, the was the progress. various Can cirrhosis feedback maybe to also endpoint in was discussion are to talk or maybe shift those you to a at we table? questions the from maybe on some talk at? know guys, much. were so way what or could sort AASLD endpoint. analysis to at like Thanks, coming you'd it do or relates prevention there of potential guess, that about hint and to getting as What data seeking there. congrats I And you're around what to away about related, EASL, who example,

Mark Pruzanski

is to Mike. obviously clinical in study. question, it's progression portion outcomes outcome the sure the of because And a defined Yes, good cirrhosis a

as We the enough a expected in definitely a placebo. As XX in of of time, size. definitive favors large a over trend a months we've that period before, OCA statement make sample to don't this have relatively short population mentioned except XX

XX to important to And success it up do trend the XX I to in that improved just ultimately sorts taking do in cirrhosis. analysis the the is of four against placebo. fibrosis patients received in analysis bridge We prevent endpoint by by will of over far important in course and clinical on think is presented progression basically you at one be on endpoint to XX a least repeat this to then And was that stage most I saw biopsy. practice, that worsening shift critically side EASL, my progression OCA in at XX approximately cirrhosis. that And at in pre-specified one really of in size which outcomes prepared a see improvement course, on with a where as analysis. that mentioned reassuring. versus OCA we two was was remarks, see. identical. in very if per the patients this the the protocol bring So at whether gratifying virtually and continues was this -- XX a away to By-the-by ITT to essentially clinical it's analysis, EASL in see And then sample think on really shift is great greater, patients because apart presented primary placebo. XX or close is standard of that was two fibrosis the repeat biopsy from I population also who

Michael Yee

favorable you good to what for in but prevention positively overall certainly, just know clearly, not as cirrhosis a the only trending can you, you and is say also as confident very therefore event you well milligram, rate that also very XX don't So, feel would be put I it that about that? very to follow-up the

Mark Pruzanski

incidents that across -- Yeah, of the is question? in I that to progression mean know you population terms of your the will cirrhosis

Michael Yee

certainly I Yeah. progression, I you was drug rate shift of in there table, greater arm rate if of analysis the which arm. the your part versus placebo at was a think the mean, look

therefore half patients show FXs would've of them the that of that cirrhosis half that based probably that favorable. that on argue were are to fact those progressing been Some progressing people could are

the way are I and mean, events, in in is saying the favorable you event I your overall guess that is that of So, analysis? one

Mark Pruzanski

two, I we're characterize small correct. talking this in of you shifts I analysis to remember, down at placebo. XX, in two-stage But with further be three presented numbers think of one yeah, And stage it by a X:X cirrhosis. about progression in I analysis And clearly again mean that per the don't over would want as terms improvement And date, favored break of over because we'll in future the the that, EASL we Yeah. was one, which protocol the OCA to population.

I yes, analysis very we're the what is So, mean definitely encouraging. in seeing there shift

Michael Yee

Okay, thank you.

Operator

you. Thank

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

please. question Your

Brian Abrahams

Hi, questions much there. and on congrats all me. Thanks for from taking questions progress the my so toward the Two filing.

pulse You enthusiastic potentially mentioned the their study to are patients. showing advanced OCA to give particularly physicians more

Your feedback driven maybe access advanced teams cirrhosis. to patients by from are reimbursement hearing that preventing more progressing

whether your plan NASH So strategy in should both into more you how Can U.S. -- all the we then think used PBC alluded this And data And and will be how that I'm to that about beza, a Mark, you your at separately, question, would being the abroad, to that in combo those think OCA, you OCA? presented combo strategy initial commercial PBC you combo lifecycle little just plays Thanks. targeting? foresee speak the for setting? second how just and bit you important translate a about for synergies how wondering pricing EASL.

Mark Pruzanski

I'll take the first to question. the Brian. Great, take Jerry ask second. I'll

Jerry Durso

these recognize unmet bring be prescribe the connection positive did survey to what the NASH and we of therapeutic It's the feedback time. need might see some Yeah, for Brian. to physicians able in Thanks, good patients from agent and result as good I the pulse first a OCA Okay. get a initial to their to willingness the with mean, profile.

is On drug se, there. it going launch payers focus of per will common the the one elements as the of us need a around I key on metabolic yet to on OCA more primarily particularly based are to points on proposition highest advanced allow where fibrosis side, a that the payer working of may the patients the think bring be to that the go OCA clear, also a the that us treatment will early lot there is with about first There fibrosis we front. a and brings depth is benefit to is others to group be pricing like too benefit need and good and but it's unmet a There be will population. the to for able that And the value that across benefit benefit will pricing find the the important. the differentiate a both allow recognition physicians into really ground

a do. of quite So, bit to work

to As imagine characterize research payer state conversations, disease access I the one having on We're would the price end. the no and that point, doing the strategy. this discussions you at front elements and could on be appropriate doubt the of the our ultimately market strategy commercial our on the key are launching decision will

Mark Pruzanski

overlooked now. is to the year this a very U.S. Yeah. us announce the And earlier with right market respect We that excited this longer-term opportunity being the that is for in to bezafibrate, appreciate question, because think license. I were

data pipeline that data, investigational PPAR of bezafibrate PPAR. of about safety published long outside the based Of the in its class, and a got is and many of fibrate set markets pan-PPAR by now approved in the be the time. any U.S.. the to an of in in as It's it's And other on as right published far the or NASH. for biggest any good any all is excited agonist just course, it PBC reason appears And away also competing NCE the a we're course it been for US

in improvements our did our further see to been four POISE add-on on dose line in phosphatase study with in second expected, Nevins because an for actually as bilirubin coming improvement PBC fixed out data drug to benefit. pruritus. improvement with Ocaliva another pursuing Fred presented and with by further in focus months exciting therapy The six alkaline significant of gratifying and to experience years, beza improvement -- combination to for continue here the the thesis The on also the course addition and at five in initial are OCA, We of of very PBC. corroborated EASL patients, beza who'd were

entrench from So that asked, combination the in you second-line runway. significantly us further course third-line LOE give over will longer of will market believe standpoint term and in PBC we the lifecycle us and this a

On know, beza again PPAR mentioned in a I do combination is in in next to the remarks we next intend we to the NASH study NASH. reasons, for side, good same target FXR are that and in you my as our most view that prepared is popular NASH this the PPAR --

very from on So we're excited this but combination, to us it. come more about

Brian Abrahams

Great. Thanks so much.

Operator

Thank you.

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

please. question Your

Alethia Young

Hi, for guys, on taking Congrats quarter. thanks the my questions.

that approval at Sorry, my point, versus two voice. that just what as you just wondering I buy You along non-invasives, they launch, the the use, how a to second maybe of and payer-FDA, they too, actually. I've bit kind allusion in an per think decision. just are a year of I'm losing do can making around you it's One, like puts but important something next are think Thanks. the on these or more it little on you Q&A, -- in prior question One talk questions back And similar? of different the about more controversy? made the reflect kind protocol, a ITT as potential like with well? on a investor are And still takes been like and data,

Mark Pruzanski

sure thanks. Yeah,

endpoints, endpoint a mentioned the ITT single an from on REGENERATE at I primary the the patient represented the of Indiana or was success with have a Meeting was to least gold both biopsy because had in this, absolute population. patient this at you drop repeat then EASL, can of obviously failure biopsy, receive based you one at in as that primary And who a analysis. every endpoints it don't evaluate a randomized standard, you a histology included a where in of So pre-defined repeat if in analysis only dose drug like course the non-responder. categorical out, Investor And you're

any intended drugs patient in pre-specified biopsy. even to which in hepatitis way endpoint, out study clinical repeat is Per hepatology examples the are in and protocol the of improvement prior there this this agreed we course, course the case analysis. in the such are absolute evaluable pre-specified effect a with -- compliance read was drug So is read in gold in and out assess There in evaluable i.e. best when histologic used based the on of sufficient lots as and on is population. but approved viral only standard standard patients of evaluable

between the per which identical the of which mentioned supportive analysis, were my as answer you mentioned were as example, ITT on this placebo, protocol again literally the to worsening and imbalance no between any OCA analysis the mentioned, patients. OCA XX is dropouts. first XX case. benefit there just per for of in ITT delta protocol. is community between for for and I similar Mike, the or one than Alethia, or is of And So OCA the the one the those readouts terms very in or the or improvement I scientific And shift in arms each X% whether less evaluable of

NITs, to respect that. in doing what take of population. drug With representative the very the Jerry I'll to ask So is

Jerry Durso

things I Yeah, Alethia, area invasive, and carries think last out across alignment is off about how feel evolving the stakeholders. the some biopsy expensive. the pretty there progress of risk the good we are coming there's quarter, It momentum in and good market. big Obviously, of and

patients, patients, of identifying tests education to role that the to in ensure forward. in move part continues setting, the that confidence clearly are and going utilization an the We active this patients, everyday that look how at the playing of about and we're what going the you the the challenges do market that to are to they're evolution important about looking sharing and of carries will NASH particularly more monitoring If forward. think play payers future specialists be on biopsy moving have diagnosing in increasing view

some good of I discussion the easiest and access, think continues tools, with obviously tend lot we data other based blood the of a terms diagnostic simple from the feel also the to in to might imaging be emerge tests, a which Both of the of value. More but EASL. also pretty again. be

So outcomes but forward. is be to and the also not at identify predict to only going patients, move who

focus modalities side, a in that's as to is the is going as role expect we that the this ahead. these and forward important they of be an again, NASH. recognize interactions they move an do On But that that move of to discussion, payer part important play evolving, our there we

Alethia Young

Great, thanks.

Mark Pruzanski

including nobody hepatologists. sure, biopsy, for right, likes thing's one And

Operator

you. Thank

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

Your question please.

Irina Margine

about Hi question. thanks you the have one think Europe, regulatory Thank after received in taking And gone process. the has formal through talk front you bit on already REGENERATE and perhaps you. the similarly then guys the the more general if already for you been European about feedback? in good guys, in whether a the how wondering morning scientific and was could U.S.? I have the strong you perception the so, data physician formal to opportunity little advice And

Mark Pruzanski

Sure.

interactions, an don't say is in So, we that sorry have on Europe. know, which in confident MAA based comment to regulatory our of to are the fourth M&A of a specific quarter hand, guidance -- in we on data we suffice fileable believe we totality filing that but you --

EMA they not draft paper, level which I It's guidance, call think approval that you're than probably NASH out looks it. quite regulatory stringent for current aware a U.S. the at a put the more in of that reflection in requirements the

Irina Margine

Right.

Mark Pruzanski

certainly and obviously gastroenterologists so too O-U.S. view difference endpoint, mean, that respect currently of think I there. strength NASH we there of hepatologists European in were With we've ongoing kind on is and and a again single challenges the Vienna, the the of based -- in in to there package. probably And yeah, rigor reading resolution have trials is opportunity you're that were there. on talked that feedback got on and my the the awareness Phase given again, believe improvement And no therapy. a out in And we think have absolute of anticipated the lot endpoint, that X particularly which if of respect I the really other hand, NASH very Phase Jerry near just the particularly X Europe. since and the could for I key gratifying what the the awareness, for that's to that we a we data that and data to, fibrosis we is in do strength have is universal with fileable alluding see to And sponsors perception, you ... enthusiastic

Jerry Durso

of a the couple Yeah. benefit point as to additional Mark said, anticipate Maybe be fibrosis we just important. would

that survey specific data pulse Just to physician. I was to clarify, before the on referenced U.S. the the

on from We Europe, data, preparation referenced clear we'll to some future, U.S. but before I make in are sure that some but just feedback sure moving forward the come we're back with the physicians, similar from the similar was data, want that I I'm in

As that look be always, and timing in market a forward access kind insight the the over time future. more country-by-country will of Europe will evolve so thing to and on

Irina Margine

much. so you Thank

Mark Pruzanski

Thanks.

Operator

you. Thank

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

question Your please.

Steve Seedhouse

Yeah. Good Thank you. morning.

the study, on in XXX your over updated powering First Have you REGENERATE on the at Gilead enrollment you is enrolled based adjusted all even I REGENERATE quick you targeting in the placebo couple effect on And assumptions have arm or all, ITT. the study? questions. the in increased was based at saw similar STELLAR-X think where REVERSE a or you initially regarding to term the and target XXX ultimately of cohort

Mark Pruzanski

question. good a It's Yeah.

with in we're I of mentioned remarks, As my in enrollment our REVERSE. very rate pleased prepared

right bodes target -- think STELLAR-X that certainly enrollment our about we continue guidance this about -- home the are be but only to in only certainly for game revisit confident looking and are you're we're town prior We're there As REVERSE. year-end. for strong REVERSE. of current of hitting a well, Phase only that the study That's continued lot And to and population. the to REGENERATE with the we're it's data investigators assumptions unfortunate essentially for doing in of looking we STELLAR-X our far And something failure I in there. we're asking and stranded. in patients now, new certainly that them our X termination, know enrolling We as well to the been

Steve Seedhouse

on that the Okay. my had could One question then that take you there in a or been that quick growing that either selonsertib you follow-up another I step if on of study? business then and would a question have follow-up price And substantial had PBC, you cut OCA pretty nice gets back. and obviously patients PBC. treated to enroll placebo saying Are that potentially with

mechanism just a five is beza, So for given there and that between maintain OCA Thank you that, the cheaper or any could absurd PBC that current idea? and fixed is discrimination to price than way even XX-mg an is XX-milligram tablets whether a a it's price combo, pricing, via presentation dose you. NASH or

Mark Pruzanski

represents mentioned. yeah, with mean franchise Europe a step we but and overall building announce drug. fact, And I respect in combo mean, data adequate of to I filing presented to With right that one I certainly and the -- current an bit to way, -- strategy to period by time strong we've from an in as there's we to intend number follow-up the there is patients as value are is would case. an to screen the are tell early And a our hope upside a And such differential We case the this clinical to with PBC. pricing, speculate, base preserving up And said forward PBC beza for preserve can come The to supports NASH brand, in out and for opposed combo base screening. our trademark -- data the different too into one SNDA. Whether there lifecycle that you patients build STELLAR-X, in it's Just possible yeah, quite the at study before, with certainly that brand, a of franchise. number great invested -- I on consensus from in different more washout beza we've represent it's therefore over EASL, the from REVERSE. price, proceed REVERSE of enrollment, core now there up as we I with did price. today intend do NDA to as are

Steve Seedhouse

you. Thank Great.

Operator

Thank you.

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

please. question Your

Ross Weinreb

question. for Ross on Hi, Thanks this is the taking for Salveen.

pruritus Just and with FDA around in the seeing that the high that progress strategy what the events to titration you about you terms dose strategy? dose. around you XX-milligram of we're of talk made Can how plan approach there your at

Mark Pruzanski

Sure.

up case filed haven't on prematurely PBC where titration have the five in with at the is from as just strategy It the successful But that is that we'll of before speculated side, possible strategy XX. we point yet. titration NASH. to kind have same we I this end So,

So the FDA this of decision the place ultimately be in be review. of U.S. of out the commercially the there context will obviously the a XX will

respond did with While active, is hurdle statistical the the this there that are presented based meet end we to it's do population patients milligram that data in that dose XX. the pre-specified on do may the the XX XX fine clear not all the for success, just and

XX, doing to predict of and those how the identify the predict a going going part early mentioned story effective forward. That's who know are for response. -- work of right this But be to effectively I don't too now dose. speculate as I with to then Jerry, as if you? availability non-invasively the to whether we're patients about big try or an So, titration the to confidence

Jerry Durso

rate questions of that context I is leads of pruritus, I patients therapy I know potentially how in we expecting good a think are Yeah, we the feel the the on the of pruritus in study. saw, work of do to a that world amount mean obviously pruritus effect. real The we've we well-known It's in the on guess done see staying one ultimately to about and I this.

for ongoing this. of a there's lot a thinking time So long been on

patients on in we think as mild part NASH vast most saw lot launch. the therapy, was data course, important effect pull the will early over at remember, a the as for the we the we've we to majority patients on helped pruritus look of how It's through to PBC in on OCA education market staying we've that an also also into true of pruritus done, we've PBC learnings had therapy. there where the That's support at is of learnings and particularly have they of patients EASL, XX% of and manage I that of to moderate.

across we the other on this their they to is also whether is or that's impact. think stay I drug a important, of is by true feel the thing patients and lot therapy about, having when and willingness a diseases, impacted not chronic positive think

they're impact the some And tolerability, I it's the So that efficacy. -- liver only exciting OCA the one consistent that that patient on also in it's of data enzymes confidence fact the of them persistent the not they through around might think elements therapy. the be market gives make the impact on to have and and reminders staying manages sure in therapy a as of reasons

situation. So to the And so lot work stay REGENERATE. we're that manage in goal benefit helping of that to place get therapy will on this be that our again, shown make can patients they sure sure the that in make we've

Mark Pruzanski

story the investigator from that out -- vote this the protocol Yeah, telling. tuned and patients patients. observation and grade There that terms on OCA from despite outcomes. feet stay the more by in only the pruritus is group, XX-milligram is of with no was their REGENERATE is study one patient that in in I'd overall add about the discontinuation telling of for mandated from the with itself assessed X thing on difference very half discontinuation reported Patients treatment in there

Ross Weinreb

just include follow-up application to XX-milligram is filing a clear, be XX-milligram the to going and or And dose? Great. your so the strategy filing both you

Mark Pruzanski

both. Well, for we data be certainly will including

go will NDA three all will into that analysis include the of arms. All the

in milligram So assessing FDA merits said the dose. is own on its in and I've the as yes, past XX certainly interested

Ross Weinreb

you. Great. Thank

Operator

Thank you.

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

Your question please.

Navin Jacob

Navin UBS. Thanks correctly, for saying name Jacob, my

you that FX diagnosed of basically kind much. are to secondly, the patients treatment look a you analysis, curve. identical for very the extent then between clarify, view updated highlighted protocol and fibrosis you've is years, of on that the if Mark, some think shift what feasible? datasets first if you ITT X. can categories. at an could the in stage to of So do And for in and there be stage had were that also those X fibrosis Thank analysis wondering for would be helpful sense get think patients so you to asking is subset how And as rate and more I'm FX you these treated per chance true U.S. few in many

Jerry Durso

the we're we first I'll So on working know the of segments. area and definitely on that more in one future. will the hard of that It's an obviously extremely question, important is Look, part question. this in that and sizing the the clarity jump provide

that the unique that market, in initially market puts the initially it be important it's think the the -- define I ones which a in but we're segments. to us we'll the also to position, to progress the strong recognize in and ensures first I we think, define market

so without segments, could we're segments elements discussions our That's the we and the focused heavily doing NASH that we really time. said, And at so finalize an that of going that that ones data a that payer we're sizing going trying built future those clean context. getting real stage true that I've right on be this. thoughtfully, is we've we're But these we communicate to with are always in subset to those be of going advanced that context It's of expect as one you, also make according not are we're finalizing to the the research over we're important the fibrosis to alone element population. tend as of of targeting patients looking the to when it's be size when the to market course, overall clinically really we're biopsy. and sight in to that the a and closely And the to are that for because we're of less diagnosed that that without fibrosis line the know the "diagnosed" world. biopsy specialists, that perspective of with continue that relevant considering we the them, in get it's the fact is those most data obviously a really this confirms that sure And become here,

to our So, that's you we're that again, with define of we're education. to helping back on evolve things in the leaders calls. to view here, And future come the evolving, with on as a going detail definitely we're to market segments the continuing all more

Mark Pruzanski

most shift that worsening and we've to important by shown the you as virtually analysis in was analysis, question, Yeah. With two protocol are analysis the mentioned second yes, so respect away far fibrosis was per which identical in on far part that the improvement patients. versus the your of valuable ITT different

XX mean FX, placebo group generally You in over about to we've yes, OCA gratifying virtually and FX, very dose-dependent asked treatment every sub favoring consistent similar right. presented, see effects I

XS and this plot, generally time, case other to will defined over needle we going where want you but Jerry based that assessment defined only you can which our are where no said liver to not wait treatment as to is using strong transition necessarily patients go we to ITT. between there can there to versus the in fibrosis, by for non-invasively stage identify though, dovetail to again, or and the real in I of watch earlier be do other happen of an saw world away scales we patients that similar non-invasives, NASH that be and fibrosis a with we anti-fibrotic OCA. And fibrosis which protocol sticking the from a just CRN, biopsy the are eligible You something advanced presented is on segmentation that conviction with intervene in definition like have believe. and back with stage, disease patients Vienna, virtue categories histologically to per in make

Navin Jacob

that how there Mark, mean are or is out of various is algorithms been things that have are non-invasive guidelines that ? the there an it amalgamation I currently And on done? specific different

Mark Pruzanski

that AST, yeah, more ultrasound mentioned useful is APRI of that's of clinicians meeting bio-marker approved with invasively and based with, and has attention identifying various the also way assess undertreated versus of patients. course majority what clinical more that diagnosed liver There clinically modality today the biopsy. us the ELF I'm are more the which care is non couple enzyme ago, just health even combinations patients our But not is point fibrosis i.e., mentioned patients and markers, more a like been one undertreated clinicians generated the and these patients my reimbursed. liver are and are are the FIB-X -- prepared their had of market yet. I'm fibrosis just standard the world there scores And, remarks still already research shown each a and markers. there a to investigational, that saying composite Yeah, diagnosed practical easy bring starting way, tests these in in a is there I patients think care earlier in or going. a accurately look as which matter, ALT, without by But is Jerry data more routine of with are that suggesting to FibroScan, of where the on stage more fibrosis. these you minutes and see tests non-invasive practice we sufficiently identify validated these more used that's advanced as very And

Navin Jacob

Thank you helpful. That's very much.

Operator

you. Thank

Brian from question from Baird. comes the Skorney final today line for Our of

has disconnected. Your question, please? It appears that he

of Our Olson from final comes question, Your the question from please. Oppenheimer, Jay then line

Jay Olson

OCA was in, you to share with could the if us, NASH. squeezing Europe Or and with thanks the your I a us if in question then research, in the market treatment from of Hello. research. conducted differences particularly regard and you with patients insights with that that And use payer NASH, have had for Hey, you me U.S.? potential regards follow-on practice tell to guys, any can in of clinical only for

Mark Pruzanski

several hepatologist survey referenced pulse we've physicians, based times The that and gastroenterologist. was Okay. U.S.

Europe, the conducting be specific work was we mentioned, the elements. similar in data There to U.S. As I some will but are

interesting of more actually the side even in the frankly and discussed, U.S.. just progress in of one think evolution the elements the non-invasives, Europe there's we non-invasive on I

research But the will the think, some I we sure market always come as additional some future. again, nuances. with outside find we'll I'm U.S., in So, back

Jay Olson

may treatment? that. monitor stratify feedback with patients plan diabetics other Okay, improvement done there to patients non-diabetics determine feedback on to with with be to And regards regards patients determine for thanks an appropriate treated? which duration they how how factors should you've then, research Is or also these of any And in on to it any stratification payers. the to versus

Mark Pruzanski

of the risk patients to they the is will patient. are in that something one a looking coming it's the non-invasives yet. it key the for a I'm would of to that be of that that algorithm feedback notion lot are But some part having That future They elements do and identification state referencing that I be, is is I the be exactly is I of likely of discussion. think disease patients is coming payer I've to but at they're an look right and be likely research The and with one sure key important discussions recognize that But to through at premature market the monitor that risk, you impact the are Yeah, under advanced is the an fact in of and course, progress. that sure happens way. as at the the discuss concept the certainty to that they elements payer acknowledge. how teams time. would be making and dimension, of on of how can't going over give this the patients that initial, of been will up, NASH some exactly mentioned, both process

Jerry Durso

you clear no at you only other the be research that type that, that much the And focused REGENERATE risk fibrosis stratification And and going about is to develop in of right greater I there's NASH two thing advanced saw are This fibrosis. only the clear is diabetes would what's do of in the is fibrosis. as puts It's on also fibrosis. here add progressive and that, is thing cohort. while certainly payers hint non-diabetics

Jay Olson

order patients remain any therapy to reimbursed? to would to Is on response from in payers a be and continue indication there need that demonstrate

Jerry Durso

routine no talking FibroScan, tests can of I care. tell defining is remarks, knowledge, part NASH for my about what monitoring respect prepared resolution. to non-invasives, There my is as about real to treatment certainly whether are that, reliably whether got assessment. non-invasives standard to think talk focused But that. one it's which or are these to blood that these in fibrosis currently going you, of mentioned you're premature the something are like I we all currently thing on be you've that with And response

a hill much itself respect to anti-fibrotic and with higher straightforward non-invasively to climb, respect more NASH much therapy. with there's an to So,

Jay Olson

Great, thanks for taking the questions.

Jerry Durso

Jay. Thanks,

Operator

your you. conference. session today's program. and for ladies in Thank gentlemen, does Thank question-and-answer participation This the conclude This as program. today's does as well you, conclude the

day. may You Good now disconnect.

Intercept Pharmaceuticals (ICPT) 8 May 192019 Q1 Earnings call transcript