ICPT - Earnings call transcript Q4 2021 | Intercept Pharmaceuticals, Inc.

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Operator

Hello. Thank you for standing by and welcome to the Fourth Quarter and Full Year 2021 Intercept Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. ? Operator Instructions] Please be advised that today's conference may be recorded. now today, hand Investor Nareg would to conference Relations. I speaker your Sagherian, Instructions] like the to over [Operator Executive Director, Please go ahead.

Nareg Sagherian

on updates, our fourth morning for and at full we Good interceptpharma.com. thank results quarter available a today's and on XXXX us website business issued announcing you. morning, is call. release Thank press year This which and joining you our

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

periodic factors not Saik. Chief SEC. Dr. in CEO, this of Officer, Berry; the results President morning's could necessarily Medical Today's begin but Linda prepared historical and Commercial and Officer, forward-looking Chief Jerry are discussed the anticipated and Financial Michelle with filings our Chief public statements our President will Officer, Development Andrew risk all differ and or Research of from press our our with remarks call Durso; those our Some and Richardson; actual materially or cause that to results our from predicted in by release

addressed. to question one We will questions be yourself to order to allow time Please then questions. in for initial to the call limit take all open

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

Jerry Durso

everyone. Thanks good morning Nareg and

as CEO, year has our and next support we solid XXXX growth. strides for first embark achieve great us capitalize enter this made on chapter put and foundation the as on the we a future objectives year our on my opportunities to pivotal performance Our corporate to in In Intercept.

PBC, FDA, and we REGENERATE sharing FDA biopsy safety meeting the support generating the will a is complete. which the Looking label globally the there their will that study, Ocaliva data the for of Ocaliva capitalizing our with be package revenue PBC million, look unprecedented ended could update. and progress The despite of the now growth been are delivered performance in looking double-digit from sales and therapy and significant After an this in work physicians as as with look significant with largest we're to data a strong data NASH to year. data pre-submission dialogue we last to continue the when is reach path the the our field. Ocaliva the an new first appropriate half potential still work of in continue this team this We have and and support data of the our of important pandemic the made population. with a year adding expanding the momentum associated worldwide reading in first of continued US to the to package forward at magnitude set, set the it, extensive forward. of focused NASH forward target OCA including role at We've year as our to XXXX adoption $XXX.X deepen the second-line what data on understanding updated number a work also with methodology PBC people determine benefit from generating scope robust consensus year efforts of potential with a will our who treat on living towards disease. REGENERATE that We challenges If to

Our NASH. REVERSE, second in Phase X trial, to cirrhosis is compensated evaluating patients OCA with due

of well generation provide biopsies in of data REVERSE method. as we magnitude that from population with our the now call. data this of about are third reading the associated as Given information Michelle the later generating the quarter. complexities cirrhotic with move will status We expect the the the data these new delivery in compensated will into more

Phase in people to active only remains in fibrosis REVERSE the only demonstrated compensated an study which trial the As NASH. compound with NASH, pivotal Phase a with improvement no in reminder, living has and investigational NASH REGENERATE due X of remains X worsening cirrhosis

together, and include the field these to sets We across data patients and the data. represent look and REVERSE largest more robust forward in sharing studies. REGENERATE Taken X,XXX important both than most

program We've and in team We the programs made past areas FXR and right later progressed in an liver next study for INTERCEPT's fixed-dose experience while important and explore to I'm a OCA to continue continue strengthening medical executive in these call. in of talk in that to progress initiated pleased combination development. to assembled also with as we meaningful focus will our our development disease. the a growth note significantly of We Michelle XXXX, pipeline achieved XXXX advances we drive in Advancing be the will that leadership the first-in-human for and next-generation our INT-XXX, year leadership phase bezafibrate agonist. more need our significant this about team.

debt successfully XXXX Additionally, of near-term notes. address we convertible the the exchanged our of maturity majority to

growth, will the steady cash consecutive quarter This, resulting than with $XXX to We also versus our to XX% with path alongside people along we third top pipeline we where that in confident strong grow that And will significant forward dedicated for remains, commercial we've path program diseases our innovate need. an With to and of regulatory update later, on our year to fourth financial and and I then from SG&A review R&D a to the drive our the over on deliver of cost our XXXX. in working continued which PBC talk will year year foundation positioned important Linda, development about future. the maintain team, expenses, full liver allowed the performance with Andrew and history. for performance. position commercial our with living decision-making now strong forward. remain data-driven our and company's on on I I'd will progress activities, savings. behalf as is to like business, making conclude define by the Linda? to poised line quarter opportunities of transformational to us as prudent as strategic turn remain with drive year, will a provide call for in opportunity a elaborate management, our be summary, will in continue of focus decisions another significant In our Intercept's unmet decreased which XXXX prior for Michelle more Andrew who NASH well the we performance. we're Intercept data a built in look our a our million expand XXXX.

Linda Richardson

another double-digit approved Despite performance as some market underscoring line for of Thanks, as I'm the our to commercial the year only drove agent the for business. use global highlights PBC. ongoing share in another sales we happy strong XXXX, position strength Jerry, growth, the year good pandemic, second everyone. was and of of PBC morning, it of Ocaliva's

the $XXX.X versus year, we increase the million the an For which prior quarter, the global same Ocaliva million, in net XX% full year. $XX.X represents for in XX% of we growth XXXX. globally, had of reported sales And over fourth sales period

launch. post review able X Let's to we how this years were growth drive

commercial focused, multiple were label our back to efficient First, the manner, audiences we to porches communicate able promotional in team fully update in U.S. pivot a exemplary HCPs way, an the managed the to in messaging other and September. to changes patients using

coming use Second, as made POISE XXXX. were extension and from work our appropriate excellent wealth an the insights the III long-term of leverage we've Phase We of safety throughout able to from this data open-label, organization, successfully study. of

highlighting the we we factors same from stabilization third impact the PBC LTSE with positive data quarter, and monitoring important shared on ALP cohort progression. Ocaliva a First, showed that has in of In bilirubin levels, patients began of maintaining the fibrosis.

told an how need creating second-line may beyond a in lowering of therapy complete Ocaliva who layering have benefits and that key ALP. This us picture important messages consideration more is patients is physicians benefit of go PBC. managing Something these

of I'll international thing highlight in outstanding the performance regarding led third our where markets, and sales commercial Implementation messaging to marketing execution in XX% The increase strong our annual multichannel XXXX is the in demand. year. an underlying strong we prior achieved see higher than of we growth

In patient trend data early projected continuing. surpassed new acquisitions and in in this sees XXXX XXXX targets, fact,

as markets line a to their of seeing strong the could performance, bring there While benefit contributions Italy our that and of we who therapy We Spain coming considerable additional from other second now PBC. a are addition remain know number patients from manage consistently well.

Some have that shown ever US second-line of only about eligible agent. patients X/X a have received estimates

year, to PBC for XXXX, major creating to bring appropriate again their team's In benefits I'll Dr. that I'm the treatment campaigns, leveraging Michelle? global performance, from be continuing patients In is promotional proud and XXXX. in and and the over those new and years focus to education managing closing, value conferences this Michelle now in Berrey. Ocaliva. bring continue Ocaliva HCPs call Our actively the to the have forward person progress attending past patients, on data being updates of sharing and turn I to we show could the reevaluate the to to with on look can will on we of insights appropriate market. passion commitment commercial of our to

Michelle Berrey

than on today Ocaliva Thank a on in evidence years, pipeline. good I'll Ocaliva our NASH approved supporting first our XXXX, large we to providing patient evidence in continue PBC. was updates generate the base to be development continued morning, everyone. to you, more on XXXX. for and have marketing Ocaliva work Linda, XX,XXX and We PBC supporting add few In program now in our since

understand databases are real-world improvements. how to beyond We better the leverage data clinical therapy into evidence show to benefits with continued Ocaliva these looking multiple biochemical to of

long-term expecting but who to treated data Ocaliva. a late-breaker with with to meeting that from the deliver These POISE We showed survival controls, data individuals as statistically eligible score had Ocaliva greater study, PBC are extension first propensity with now treated last not transplant-free abstract a significant than publish are presented matched our November.

are and of have the We the global soon as a will manuscript submitting publication. journal as disclose scientific details we confirmations to

with addition planned for In to these we other COBALT, study, data submission the included and support later regulatory a for expect data year. this and outcomes publication, post-marketing be to our

therapy a noted multiyear a benefits placebo-controlled maintaining on commercially our of study because the of clinical been patients was outcomes, but As in the we've when to with in study, XXXX, third which closing is confirm COBALT out quarter we designed available. challenges

been discussing EMA second have we'll a half regulators, We and FDA of XXXX. the available that evidence including placebo-controlled anticipate submitting the in to we data broader be and options with package both in

these also the additional leaders thought We in-person and data at and meetings presenting opportunity to advocates. later scientific about our anticipate back to get physician excited this meetings with some are year

substantial data is in agency's and line NASH Turning XXXX. REVERSE Last year, OCA a half to this program ever we amount in liver to methodology second new of REGENERATE compensated After FDA, in with Together, reading of NASH. implemented significant NASH made using represent initiated the advanced cirrhosis with progress the a program. we for Phase guidance. on that new X largest consensus draft dialogue fibrosis and conducted our the due and we generation methodology

REGENERATE. previously with to a FDA also active the in We from data guided, We're cirrhosis as support a in due late-stage year. generate compensated line potential if our it, are the study, continuing this REVERSE data from to only data And continuing first the targeting pre-submission package study work new top towards we're to of meeting half NASH. we've readout

third of magnitude from year. to using anticipate complexities data We quarter biopsies with data as line these a time in multiple required a this data now the population as cirrhotic have external REVERSE, associated in of well new with the Given more delivering the readout. top parties is reading the methodology,

to to the on data REVERSE, REGENERATE ability focused Overall, REVERSE FDA the As our the the potential NASH time first meeting regulatory data these Therefore, set. hold in in upon generating a the reminder, have in efforts from our data support accumulated of be pre-submission continue the a will a set from the we line of should the data largest amount And analyses unprecedented. we're in perspective, not completion is these with REGENERATE and half shifts REGENERATE will it. from impact field. year, of the

will now will the prior database safety X.X that, database of exposure and of include REGENERATE an the patient As assessment than the drug more include of and additional evidence submission. data of times safety the the analyses XX months comprehensive

month we include the working Despite In unfortunately amount in now new four data they X,XXX a addition, the XX, soon analysis as more have of this to will across reached data industry, on substantial these OCA's important will profile. years are perspective who've almost significantly subjects of hand, provide being benefit-risk data. Once treat as work possible. approved therapies still there done we no and these NASH, to deliver robust are

beginning the Phase our better have to the second to Phase study is trial. X the in on OCA combination we several we for Moving of plus screen bezafibrate combination our large PBC. fixed-dose trials fixed-dose data are our for and pipeline, In X to ongoing, US, clinical patients ongoing exposure also our characterize

other when key our in potential are the will be PBC. our the in patients doses action carry shown been associated X long-term fixed have diseases to medications We biochemical markers in used believe studies that that the a help three cholestatic combination. benefit Phase We the to will enroll have improvements included inform predict X. to Phase dose we're with with PBC lower study. we mechanisms that individuals OCA in in also program. been exploring of study international phase benefit Both in outcomes These bezafibrate has Phase potential X synergistic Bezafibrate pruritus, to and continuing and combination in early

next-generation our forward sharing We're the addition, look and an our of to of information. and in determining in target of submit that study indication half INT-XXX, first agonist, ongoing is the X expect FXR we Phase this In to for a IND XXX year. process

a now are Andrew We over about for applications. Andrew? the financial call this very and excited update. compound potential turn its I'll to

Andrew Saik

financial good ended the you fourth worldwide XXXX. morning million everyone. $XX.X the to of year of up $XX.X I a we refer commercial in Ocaliva and quarter Michelle million XXst, December release the fourth recognized full XXXX. press with in please results that for quarter that Beginning summary ask issued Thanks our today and performance, was our quarter, fourth net sales, from would our earlier in for

the worldwide year XXXX, million net the million compared in For to full $XXX.X were Ocaliva $XXX.X sales year. prior

of and sales XX% $XXX.X sales net million, ex-US comprised respectively. year net representing Our $XXX.X XX%, of full US XXXX Ocaliva of sales and net million of growth

year. quarter Our million of GAAP $XXX.X year million period. $XXX.X the totaled of were fourth adjusted operating expenses versus a operating the which fourth for decrease million, prior versus in million was the decrease quarter, $XX.X Non-GAAP fourth quarter the a expenses last $X.X

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

SG&A SG&A million for of non-GAAP from the quarter adjusted the expenses period. our million year versus million of XXXX. compensation reminder, XXXX. a year sales XXXX, the quarter a $XXX.X million decrease expenses $XX.X were were for $XXX.X fourth fourth depreciation. were operating full exclude in of quarter, Cost to million of expenses $X.X $X compared $X.X As decrease stock-based the fourth a the and prior million in

compared Cash, quarter cash Our from for was million period the R&D million. of totaled our last $XX.X million equivalents, programs. of to NASH same XXXX, decrease and securities our year. investment for the were full fourth sale two-thirds expenses And cash the Approximately to full we're full million million spend year-end year $X.X available $XX.X related year debt R&D XXXX. $XXX.X in restricted a year $XXX.X the at as for

untreated $XXX the first Ocaliva's full PBC million to the anticipate globally the Ocaliva, label number sales patients for Ocaliva the from guidance financial and a we XXXX we and guidance our significant could million. position This this expect between be of contemplates strength benefit which market that implementing year of of half year, to $XXX Turning change, net EU year. in

and relative first insurance years, Medicare a what seasonality plan the similar of prior is the in QX seen faced Therefore, fact with to revenue we resets rest in patients quarter at to expect to year. due year. Ocaliva the we've the As subject the lower reminder, beginning in gaps the are to coverage of that

fibrosis additional trial REGENERATE our OCA ongoing NASH, trial clinical XXXX We $XXX and and between regulatory pipeline efforts to our in expect our full continued commercial be and reflects $XXX guidance INT-XXX. in to such efforts due as post marketing adjusted of range expenses operating year non-GAAP This our X investment the in in million Phase combination million. PBC, Bezafibrate our programs, and study

spend readouts steps Our is be on our current data for as $XX.X by subsequent year interest expense based Even expected capital support commercial we as expenses well our to in example normal over our to and that expenses. and in $XXX though opportunities NASH our the the is meet million relative expenses potential ensuring operating the SG&A this to to containment continued general the Cash headquarters managed on reduce NASH while cost structure. our to regulatory One decision to our manage to relocate to Jersey. of we continue recent million prior year, to year invest objectives. focus New company find next Morristown, we business

Our cost XXXX we we I significantly continue management and by the balance successfully strengthened believe derisked sheet Overall, will the pleased efforts progress very our in beyond. with exchange that We made executing foundation. financial the materially us have an am and are convertible we our XXXX into objectives. that that company achieve financially for forward strategic our help our moving three consecutive have we believe We notes support cash had spend reduced we and and well-positioned such quarters. stable to for

to back the the Operator? to operator over it turn Q&A. I'll Now start

Operator

Instructions] Thank with question you. Young comes from Our Fitzgerald. Alethia first [Operator Cantor

your proceed question. may You with

Alethia Young

have on forward give Congrats if see I color keep time question. line you was shift driven, guess, just the going kind my what's event us and is Is something going Thanks. here. there? kind there taking any that or moving color going on, Hey, to I REVERSE. could of or I’m guys. Thanks on give COVID can wondering else might of you just it on more for you us to on

Jerry Durso

Michelle, Hi, you. question an good important Yeah, to to maybe from Alethia. hear into. start, for can obviously, Good morning you go us Michelle?

Michelle Berrey

Yeah. Good Alethia. morning,

wanted to or clear in there's I interactions. no in overall regulatory that our be our delay First, program

still discussions deployed are year. of had parallel. and we reading the So we FDA our in panels pre-NDA have the first then in the meeting half intending Remember large reading two year, last the studies the multiple with methodology on to

say regulatory the REGENERATE focus not continues pre-NDA delay the third meeting. So on is going the to study, the to although be I our REVERSE interactions the major quarter to in What impact patient specifically quarter. advanced can study. third now about expect so complex REVERSE more is the population it's cirrhosis, It's data study large with into early the given the a we those

Alethia Young

Thanks. Great.

Jerry Durso

Thanks, Alethia.

Michelle Berrey

you. Thank

Operator

Thank you.

next Yasmeen Sandler. comes from with Our Rahimi question Piper

proceed You may question. your with

Yasmeen Rahimi

team morning, you Good thank the for and updates.

Just the same Alethia going along raised. that thing

report still And maybe at two is quarter? not that question the you one. like be share thank you you be you're -- then will And the histology for could first safety almost there of REGENERATE reanalysis, REVERSE. of come there this some glimpse Ocaliva when still we're Why for second with done So that onto with we just data it this the not line? know taking quarter, is any that's my provided with safety I that questions. able seeing population in commentary the going this in you Some out But quarter. say the looks to may hope the look when us waiting to into analysis. top That's question be is REVERSE fact

Michelle Berrey

Thanks, Yes. Yasmeen.

question. was one in really that's that safety try REGENERATE. additional I REGENERATE the things pull from And to on data again, the the we think of wanted So huge a database, to

now we've added year. -- another So

database. of we've safety XXXX all So our to added

now we what about analysis patient submitted out XXXX, patient patients yes, initial X,XXX now compared X.X we times had X,XXX to the over excuse -- the years. with to back So interim have patients X,XXX almost total years. four to And to of me, We're number importantly, years. had we in out

we point to really that So wanted was in. critical pull a

for We REVERSE the efficacy. do same will pull the at that safety top the from line the time we

data it's cut-off. to important your the lock database So same on

have we'll efficacy the time. from line same that the out Well, coming around time, safety So the same data with the top REVERSE. at

again, So there focus a would regard the the main FDA, safety lag with those. to on With between have won't of be timing, be REGENERATE we But little go an today, think too may the database. our much from more in But quarter. at into for speaking it earnings point. call May that to and we specificity question. the a expect I Thanks the have third pre-NDA

Yasmeen Rahimi

you. Thank

Operator

Thank you.

comes next Michael question Jefferies. with from Our Yee

your with proceed may You question.

Kelechi Chikere

this for a thinking different the want little Michael. Kelechi what of REGENERATE more question. Thanks just study an on the I Hi, ask about you're taking to and is for get are scenarios of. understanding kind for my

X and that drive So, ratio magnitude view base of now and the that the and case the you in -- larger at is Phase the database will the data safety hazard least that study better is and approval. shows even effect same sorry, management positive risk

what yes, about your here and is you how that? thinking So, are scenario

Michelle Berrey

great question it. you it's I Yes, a and think nailed

about tolerability are so year the So, important CRL the for NASH, four. XXXX rest that a -- sure important was have there question safety at really When And we we safety on I data be now OCA the make long-term database. more Ocaliva, of that we much safety understand events will am not patients the much now lives we they're their to robust expect risk. in benefit we three, that it's have year for on new from

XXXX. X,XXX XXX now XXst, patients we patients, almost So, through December have

new of a into we data. important that's year months really So, of We have XX, interim out -- four. back XXXX set analysis, the --

a we much safety us database, drug. much gives feel overall So, benefit which better of assessment it's a for more the risk the robust

Kelechi Chikere

Thank great. Okay, you.

Michelle Berrey

Thank you.

Operator

Thank you.

Markets. Capital RBC with Abrahams Brian from comes question next Your

your with may You question. proceed

Brian Abrahams

question. sort matter of more for of time? finding the reads on I wondering extra the bit variability, special Thanks on my might a population to of hurdles guess you the or respect of Hi, key of think it to Is overall just given any was population. we good biopsy cirrhotic the reliability require if -- will the REVERSE, severity this I'm of wondering protocols data disease the elaborate this for see data. in that the matter some readers a could Thanks. generated how when taking about be With morning. sets little delivery I in or that histology just

Jerry Durso

morning. Thanks question, We're keeping for the this busy Brian. Michelle

Michelle Berrey

morning. Hi good Brian,

one to of for critical population. understand not important So, any patient reading the population things compensated early There's have it's patient. I about the an don't drug still in to practice, differentiate do Unfortunately, is from to treat you're patient think nothing available that advanced NASH. really that approved going cirrhotic early cirrhotic clinical fibrosis differently clinically to we

So, critical it's that a critical that obviously FX trial, differentiating. clinical it In FX. differentiate to never been high really are quite these is however, a from a pathologists low

So, had panels. We of yes, parallel additional that involved. deployed elements some training there were are

had FX be that we FX, attention those paying panels on So, make to the special they sure month Clearly, separate were different as moving they XXs and forward There to panels reading that high was some REVERSE well. going to important low pathologists REGENERATE differential. study. for the training when for that's to progress

early advanced is element, it's this in new advanced the second this fibrosis The we're -- methodology. And third, trial deploying only cirrhosis.

methodology trial. So deploying the REVERSE through this applying and lot learnings to our those we've a new the learned

Brian Abrahams

really helpful. That’s Thanks. Appreciate it.

Michelle Berrey

you. Thank

Jerry Durso

Brian you, Thank

Operator

Thank you.

& Stringer next with Our Company. Joseph from question Needham comes

question. with proceed may your Your

Joseph Stringer

for Thanks on my everyone. morning, Good Hi. PBC. questions. A couple taking

increase? price the what this post that into PBC, your is feeling addressable market the PBC Your XXXX penetration percent on launch sales a And volume five sort years to secondly, of what's patient opposed point? growth in at population guide, of as

Jerry Durso

remarks, you now question and questions push Thanks forward. as how at the good for specific and in think and we the the that we PBC. view to the the prepared XXXX we're in look the with I provided? growth the feel guidance on to we we about Andrew, made XXXX Maybe, sales Obviously, start said progress looking

Andrew Saik

the sure. Yes, question. for thanks And

regard are and growth we international. PBC continued volume expecting the in with to U.S. So growth, both

we're to right and end, the I hit in end our growth end. to see the a expecting enjoying gave it take deal think growth low guidance, be would US, now. wouldn't of -- the need on But the be higher we're obviously, a international continued range obviously volume great to to low of on we we which

Michelle Berrey

to I'll mind. on Yes. tag you that, if don't

really to information, to the I there creating some physicians bili, second penetrate We at ALP a that on not at based treated the on the severe. when lot confidence physicians ultimate Ocaliva we and we we This access noted, of to goal of fuller the into market stronger shows to choosing market hepatology that package line, add because think, when of line and number Those we manage are of prevent And that really really to more in liver the in showing years know reading depth. with before ability research land. this is is to to. with it's we're are we've than treat with for much said as the as a institutions, about and are you market, to accelerate particularly doing data where you're the important out take gastros using trying and second patients of perhaps going office five-year that It's a be this data and in we're very our what need generate consideration institutionally for to we're second transplantation that work than more Europe, there is is way end-stage agent. learning our because line. And And easier LTSE combined education I little keeping have to have new that think in with as learning that established. have that fibrosis, is, being did been the did lowering But of data the a on them some the what is disease, PBC data and therapy game’s only we low US. where early, you're in at hit it, but a and increased looking we go get we're AASLD, the stability bit it point and being appropriate across out, community are intercepted been to played. and to we Michelle very then

second to data, that. forward We intend about in treatment. one-third We've at patients of we really with US have business, approach all to only comprehensive the new the out. limitations So And getting COVID. hopefully, materials, use new we've with move had our won't seen, have overcome line

So two we being the fundamental treated and with years therapy. increasing the to conversation, see shift really second-line getting patients next as in

Joseph Stringer

questions. our taking for much so Thanks Great.

Jerry Durso

Thanks Joseph.

Operator

you. Thank

Our next question comes from Thomas Smith SVB with Leerink.

with proceed may question. your You

Thomas Smith

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

it REVERSE, like you're to the into I and there? we guess interpretation. sounds the visibility just safety the of on much you are you Can turn to factors safety us remind be of delays independent the have if to changes of data there safety any And adjudication there Thanks. been have how analysis. to the the the analysis of you I types any And events? being are if around ongoing evaluated. are the events adjudicated pointing slide Just as gating biopsy of interpreting events any just to, of that events guess, those confirm related guess types need I explicitly that the being defined, in if or adjudication complexity could

Jerry Durso

Michelle? Thanks, Thomas.

Michelle Berrey

morning. Thomas Hi, good

just NASH a study the ongoing populations, have monitoring safety, trials issues changes overseeing looking sure would So patient in that no design. good question. is do DMC there at We make the the large specifically additional these is there's require and that to that

hepatic back discussions a our with from regard events, -- have adjudications, diabetic. DMC. committees With specific patients as kidney specifically, we have to these and FDA cardiovascular and events continue the number continue look at large independent had to have we designed are of So

into separate. something that's wanted events specifically look hepatic that safety they is So to the

of specific cases, those analysis. part daily the which the that's full a approval Is that of hepatic separate of outcomes, more review that's will than be So helpful?

Thomas Smith

on that's this, as And you data to helpful. any safety Yeah. FDA I engage No, have you I set then Thanks half in just Michelle. to you the think into alluded visibility population? first the potentially can advanced confirm, with do XXXX you the expect fibrosis reverse guess, but

Michelle Berrey

submitted. full quarter, coming that certainly package should third said, the so part shortly would be They thereafter, in, as of be our in be would safety and I

through and adjudicated And the looking we're DMC full visibility again, DMC the cases. the into the adjudications. So, has

any study any kinds to there's events. more altering could at specifically make they recommendations of concerns, us about if looking the or So certainly specific

We the those regenerate are the being both reviewed patient XXX the for patient, REVERSE, DMC. population just So patients X,XXX blinded by and lock remain large both almost both database of until in the over studies.

Thomas Smith

Okay. the Thanks taking for Got it. questions.

Operator

Thank you.

next Our with Riley comes Mamtani question from Mayank Securities. B.

with proceed question. may your You

Mayank Mamtani

on taking Congrats the morning And on trajectory. the the Good for thanks progress, question. financial notably

into like on this of maybe, be OpEx on seem the conviction NASH-specific to just quick coming to that? you Michelle. there a seems rig level I the And down. anything Andrew, Can So for guidance, Is it opportunity? comment just your and follow-up relatively the investments then have

Andrew Saik

No. question. the Yes, for Thanks sure. Yes.

programs, it through is of the one our and funding key NASH end the are of studies. to committed So we fully

is NASH You as continue going to of spend a finishing will see mainly reduce. decline, up, obviously, function on our a overall that's REVERSE spend spend overall of R&D our NASH so percentage but to

kind that going to get increase year. would to XXX, this will notably going study are hopefully programs which beza OCA be the other of our and that of in up and pick combination Some

conviction no spend. NASH. absolutely our no, a just on It's natural R&D cycle lack of of So life

Mayank Mamtani

Okay. poster biopsy. other what seen we've away will and Great. And studies you about in biopsy then And from primary to endpoint, region quickly thinking and just a on at study REVERSE analysis context putting the their non-biopsy. change also learn the wanting efficacy for the from Michelle, go FDS

And the chance might endpoint now? is look may that particularly analysis. NIT right you elevate So that to into FS, attractive a endpoint be there remote a secondary primary you what the is

Michelle Berrey

great certainly we chat the at noninvasive tests. a is this But point endpoint circuit to the it's question. We heard in multiple lot regression a a NASDAQ biopsy-driven the is but earlier and fiber scan and both in only fireside these of the validated mechanisms still this at considering wet of fibrosis And histopathology. have progression noninvasive noninvasive FDA at year, interest patients. evaluate tests, yes, certainly, biomarkers other the

for as data available hope same the REGENERATE, we as have much be well study. have the time for we'll assessments agency those book progressing on So to the all in briefing and of at that REVERSE of our pulling the noninvasive of

Mayank Mamtani

Thanks for our question. taking

Jerry Durso

Mayank. you, Thank

Operator

you. Thank

Seedhouse comes James. with next Our question Raymond from Steve

with You your question. may proceed

Timur Ivannikov

Steve. Ivannikov is This for Timur hi. Yes, on

rate the you. terms of Thank terms for analysis, resolution you Could safety clarify, the the XX-months of and an type will I FDA. fibrosis sure clarify only, safety I'm have in and -- not event it for with efficacy NASH like of reduction. wanted So order safety or internal to just about just heard sounds correctly, you REGENERATE, I adding in but and just is with that to that meeting proceed submission you be talk benchmark benchmark in any to

Michelle Berrey

Yes.

we're want safety, to that. just I sure For clear make on

the we XX. still had any data initial who in back patients So at the that was XXXX. which And time were enrolling at didn't -- month so reached the actually have we October cut-off, interim analysis, study

-- we'll patients or almost For X,XXX XXX have four. this patients, we year out XX cut-off months to data

exposure. years safety We X.X-fold almost So much over database. patient X,XXX a in to increase much, larger from X,XXX, patient went

safety So much for looking robust a We're not analysis events. database. more this on

event-driven analysis this This -- approval an is only. on not that's an analysis. focused So interim not is accelerated an

of biopsies, looking those full of is again, would solely events the That on analysis clinical interim progression, month So an cetera. approval. accelerated approval. et XX not an This for be focused at

Jerry Durso

was thing Yes. challenge of Michelle the indicated would is, before, only overall benefit. the add I about as CRL course, risk of The

good totality to put that inclusive of So this the us. to set supports larger the a position I total data opportunity data going this -- and the safety think, to in us if is the outlined, the reengage efficacy, assess all of assess data she

end data to So look that defining generation next of the forward again, we steps. for REGENERATE to getting the and

Timur Ivannikov

Thank Okay. very much. you

Operator

you. Thank

Baird. from Skorney comes question with next Our Brian

your proceed may You with question.

Unidentified Analyst

for Luke question. taking is This Thanks the for on Brian. HI.

had FDA that Just data the any in you a something covered But one, is a apologies REGENERATE, regarding the hand?. pre-submission once discussions quick progression have scheduling do you you've you'll have or in and this. meeting, to on with of like if that

Michelle Berrey

plan question. of disclosure XXXX. only that for good continue we half meeting is And first a today that our in the to That's

Unidentified Analyst

Great. Thanks.

Michelle Berrey

Thank you.

Operator

you. Thank

JMP Wolleben from question next Securities. comes with Jon Our

your proceed may question. You with

Jon Wolleben

for thanks Hey, me. taking the question. for A safety follow-up on

heard Following is I've as withdrawal also I the response, mentioned potential EMA think a the bridge far discussed function, about on your MAA, concern kidney before. of as don't which effect you

safety was that you on color potential provide signal? I more could a hoping So little

Michelle Berrey

Yes.

we're the on analyses. mentioned, which data align able And So and XX, as NDA, the the to recall will cut-off. those December we MAA new just XXXX, for data be not I of XXXX, in just you'll the pulling the now the were timing end of

So the to are one data questions the in have final again, together been be respond as DMC, reviewed package. that EMA. of obviously, Those in with but safety we rest adjudicated the any of coming able areas by those focus data to being requested being of from pull those to the data will the weren't data the adjudications

as the able we've in to align just data pull all said their unfortunately, respond weren't So, to before, those on to we questions. timing to

Jon Wolleben

maybe OpEx. may on a if And follow-up, I Okay.

With SG&A, the split in R&D you jumps the the guidance to should XXXX gave in we in fourth expect and given that us quarter move forward how guys today?

Jerry Durso

Andrew?

Andrew Saik

of the pick REGENERATE on year. off described. expecting and And between as No, Yes, time. we're to and will But going programs will some SG&A, give down R&D question. we I when bit. at REVERSE up. I thanks our to don't in continue mean, sure. going not program typically Look, the is out the as as we're said, point guidance, we've get to other those into then a back we this spend ground, for it funding pipeline continue break the spend

guidance and and day expect low So, on we our while other them as expenses than to look that, we've we manage meeting at every OpEx, still our continue can objectives. as to given the

Jon Wolleben

Got color. it. the Thanks for

Andrew Saik

Sure.

Operator

you. Thank

Ed Our next comes Wainwright. from question with Arce H.C.

with proceed your You may question.

Thomas Yip

asking This of morning everyone. for is Ed. questions Good a Yip couple Hi. Thomas

REGENERATE. it EMA, discussions for First, the with you touched for your regarding on briefly earlier, Ocaliva and

to a for FDA? process the from ahead separate or data So, is go are waiting REGENERATE we it

Michelle Berrey

understood I question. the through MAA. the were sure We Not

And we a we as so forward with supported US. in could are the the if doing resubmission it, data go

in Europe resubmission. withdrawal in the So, procedures recorded whole a

procedures questions that this us to have can and biopsy much US a are larger had data of the the this But plus have in -- You for answer we'll So, up resubmitting more now safety hand in used similarly, all their we additional we time database, while. spring. any allow the with other unfortunately, didn't robust,

Thomas Yip

I see.

the year? So, ask package EMA plan data I also sometime what to half first you for guess, to I submit the looking FDA the was meant to is that this

Michelle Berrey

we a data a the be those could EMA hand, resubmission yes. we similar to as in package, Once consider well. have data would It

Jerry Durso

in steps assess We'll next any potential with data hand.

Thomas Yip

expect the question me. more Can Okay, in sounds set? tell for first what good. data OCA should year, the bezafibrate the us you this And milestones combination one plus we study then from when perhaps next

Michelle Berrey

Yes.

data some So, present later to we year. have this

looking US. Phase as We to kicking in different in subjects, data in in in the for X I so study, patient and mentioned, multiple combination study as Phase population continuing with in combination enroll X healthy a PBC well exposure conducting, at different doses as one are large study, the the X off Phase doses in Europe

next milestone our combination. optimal big is determining us for So the

potentially drugs, liver and with great As for these that to, decreasing synergistic we've cholestatic believe really and of two combination make for beyond. patients could disease alluded that between for interaction a potential action PBC there's we pruritus mechanisms synergistic

Thomas Yip

forward Thank taking it. progress the for got this see, year. you our looking I again to questions. And

Michelle Berrey

Thank you much. very

Operator

you. Thank

Merle from question next Ellie with comes Our UBS.

your proceed question. may You with

Ellie Merle

question. the taking for Thanks guys. Hey

the FDA Thanks. for half to on reverse samples? patient Just And well I proportion wants more the meeting? a get us you’ll some shifted the potential with you on that biopsy chance in any more confidence the of you your Can this additional And light can in little terms the on terms this the of to biopsies update color, new state reads data any bit are give? the color the meeting discuss FDA read say that of maybe far could both the in just the time just the frame as reverse maybe then in to could from the this in so in moved any then full and have that process potentially have of half maybe biopsy full if from And update again. the meeting of REGENERATE give or time this perhaps remaining reread as Just support pre-submission first timing? read of get just the biopsy you at where like the all? initial second and proportion biopsies the guess, read as you've

Michelle Berrey

Yeah.

with that interim the were the analysis liver presented on the that meeting of baseline number in over have month on and So year, additional the we FX, was we in majority both so methodology or all we've some just I methodology. an are panel been little the same that higher patient identify have and who is talked study, back those to compensated patient using this there same were and about XXX XX, population as those again being previously, with patients at patients biopsies at more threes, a the baseline their about we last using those XXX a REGENERATE those challenges screened importance patient of And given initial data months. and order this read have of study, talked we the FXs, FXs being XX low are either and large of we had clinically cirrhosis end differentiating again, biopsies. both the reverse in population, bringing The which of read those are at

we So efficacy year. big again, data again, will us. pulled in which same all for provide a It's and with be data year on the safety cutoff a look this sharing with the later forward of risk, good of will us little and to those assessment a benefit

Ellie Merle

the color. for Thanks

Michelle Berrey

Thank Good. you.

Operator

you. Thank

comes question Richter Goldman Salveen Sachs. from next Our with

with question. proceed may You your

Unidentified Analyst

Thanks for taking [ph] the question. on This Andrea Salveen. is for

primarily much. triglyceride discuss if looking on? level well us of what then expanded what rate metabolic? safety as in so Just further you'll what acceptable of do the you're would as when you pruritus? And it for, the remind terms you cardio this wondering see be Thanks Is increases could be focused database,

Michelle Berrey

Yes.

sure for of their think to lives. pruritus, requiring these looking you X therapy if that It's safety, patients general or given a higher obesity rest and have in general the the lipid patients of overall profiles diabetes a would about to than be things like perspective it anticipate will regulatory we important be understand the are from general, the So population. really we make that their in tolerability at these rates type that

at now X. year out at at X,XXX there look or general patients issues. I year important just X have up So popping we want are events aren't sure any new to those year adverse that that X, that also out make to tolerability it's look

that. So the boring be continuing be those been but has that good Again, We and we're at. remain specific will DMC shortly. unblinded in data to now, the things watch looking at data looking threw those out pulling we'll

Unidentified Analyst

lot. a Thanks

Michelle Berrey

Thank you.

Operator

Bank with next question Our from America. Meacham of Instructions] [Operator Geoff comes

You may proceed with your question.

Aspen Mori

for REGENERATE It's Aspen us understand, on remind need most delta that help versus the on clear the it's And gating maybe for to patient additional Geoff. if OCA in quickly, just FDA? really help you dosing us XQ, any then us you the in the maybe the off, to the of just guess REVERSE, placebo focus for to file you re-analysis expect look beza you you. database. even you if question. think does end lastly, that get study? safety Thank talk FDA And Thanks the you first show with data regulatory or US in then But the that any in the for fibrosis after generate to additional data need factors or can what point? is Do subset? that to like I for on first pathway the robust understand

Michelle Berrey

Okay.

would have it's study, the a the discussions that, look we initial we for is do also agency at interim FDA was the a that alignment if statistically that's analysis, that an and So that and accelerated focus, focus large fibrosis based first reduction on the show approval, program, in be on NASH significant REGENERATE, with we endpoint analysis our did interim first the again, that the with fibrosis. of and again,

or any that. least in We which at inflammation a patients no much worsening have now NASH more regression worsening against steatosis. who so without to robust of a compare at, activity score, we're database safety So number have X the stage of of

cirrhosis benefit the early looking The more assess agreement because population, was patient -- has So it an fibrosis, already overall, risk. is FDA one. fibrosis, clinical at for better to subsequent advanced all this reverse [indiscernible] trials want opportunity advanced, we a the population the outcomes are the study, because they much to; the and that patient that we but at had on look begun in initially, stated

FDA endpoint the we for the be and this larger look those Obviously, the advanced of will endpoint pulling do go and REVERSE this to And as much study are large the So REVERSE. continuing noninvasive tests role sites I obviously a regard fixed supportive those open are cirrhosis considered in forward. are point, at we playing, looking And have the database. of against is mentioned combination, going we be I fibrosis. REGENERATE at for are and in, are think dose to final as both all Hopefully, reversal there with But that reduction in safety in the screening. the at patient those data. those to actively primary US fibrosis, of comparison population earlier,

to patient some presenting fixed-dose in forward in in question. later look that on we this the year. our data first from the that So announcing X and US for Phase our Thanks combination study

Aspen Mori

you. Thank

Operator

And to further now at Jerry any you. Thank like I back not would call over further Durso to turn I'm time. remarks. questions the for this showing any

Jerry Durso

a across year puts XXXX I progress. day. the a a team Intercept, us great joining today. sharing embarking that forward for us thanks, work we're that really as clear, and and for in Thanks, definitely the and the look foundation. everybody, be did to to transformative did more It's business going we what's that So updates believe on things strong we really have in

Operator

Thank conference for concludes call. you. today's Thank participating. you This

You may now disconnect.

Intercept Pharmaceuticals (ICPT) 2 Mar 222021 Q4 Earnings call transcript