ICPT - Earnings call transcript Q2 2021 | Intercept Pharmaceuticals, Inc.

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Operator

Good day and thank you for standing by. Welcome to the Second Quarter 2021 Intercept Pharmaceuticals Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation there will be a question-and-answer session. [Operator Instructions] I would now like to hand the call over to your speaker, Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs.

Lisa DeFrancesco

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

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

periodic our are number limit Q&A. to in initial Andrew Dr. allow Commercial question Cawkwell, for order Linda and to will and Michelle also Development and questions Today's Senior all remarks of filings not Vice Financial President Berrey; Officer, from one Safety we'll or new from differ to in could that our a cause Intercept Research this CEO, historical but Risk of Saik; of forward-looking today be Factors yourself hear of results release and Some Gail members our Jerry begin with Richardson; morning's Chief press President in including, from our and with addressed. SEC. President will of statements the public team all Officer, available Officer, time call the prepared by to or for leadership Medical those be actual Durso. our And predicted Pharmacovigilance Chief results anticipated materially the discussed necessarily Please Chief and

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

Jerry Durso

for you focused us with We quarter of progress year embarked earnings Thanks point XXXX Lisa. XXXX the with pleased objectives. conference that And our Intercept, we've crossed second for joining this pivotal on I'm set of Thank the made. morning, Good call. as we halfway everyone. on

First, $XX second continue drive million, we double that you told of to sales PBC growth. we over digit quarter our another In we would and business. delivered quarter, the sales of

also the information. changes to market began We US, with this franchise. the label label growth on and of focus for the work in to important now foundational This important educating clarity allow will prescribing long-term supporting finalize new the FDA the our us to Ocaliva on return

fibrosis goals. we an regulatory clinical Second, gathering you in third to alignment advanced data regulatory on seeking actively quarter to the we and progressing on generation. from execute update told would due This program our you promised in pleased and feedback that includes we're and most today moving our development to NASH report We NASH. our importantly clinical program I'm ash

tell what that me means. exactly let Now, you

the tasked to of on FDA from new internal experts, number established instituting and external beginning and them key a year, team in If items of and feedback data. biopsy the you the we process the recall, and alignment a relating efficacy methodology a game with of safety,

frequent plan. gained the Since addition the largest with half exchanges on interim progress build of areas engagement significant. with our order Phase believe we strong positive way, in as data we've we what XXXX, forward decide medicines These data have with profile team be FDA from steps. And And critical made the gain has to in space, had objective readout has on will now first year, our process, generating the to we're NASH interactions the in beginning the along the and field. necessary move data in NASH package the the our leader questions a FDA support FDA a with next of as the Based continues only best to work been Dr. around now and to execute risk in have REGENERATE, the of to these with analysis a FDA throughout the very evolve. overall address in we to our the our with NASH. will FDAs leading thinking patients the produced overall Today, on ever data the Michelle OCA. disease NASH established benefit possible the of As around no III approved the enough on Berrey of foundation insight much from been

pre-submission As sets they and generate. we morning's On into FDA to resubmission. And accelerated this be could with next about expect data first the the to we We evaluating become XXXX. we'll the will supports findings continue our if data have decision of early process efficacy during is to more the share goal inform safety a on meeting details available, the potential believe a specific of internally making Michelle call, anticipate year. part approval, half

leverage our portfolio the to to also have hearing today leaders combination for report year advance to looking you would in pipeline strengths. made and new We've our work responsibilities several furthering to simultaneously the study with We opportunities meeting We'll to next initiated FXR from of OCA and all weeks new and for pleased the Phase coming that months. our team. progress human by talent team program. strong you II our bezafibrate be and in members substantial of told while We our existing team. continued for agonist expanded we forward INT-XXX our we I'm generation we look our first the that strengthening this our expand leadership added for and

in the the quarter. second Importantly, we of company positive reported quarter our history in first cash the

update of turn we our ended Linda? financial a and US. will to solid process, and strong quarter, in As to going With shareholder will commercial progress Linda our drive I'm our to value. our R&D then for guidance Intercept on the capabilities in label performance. it talk cash it's commercial Michelle still label and our well activities. execute who provide We're R&D to company's quarter in and the against of next continue position. and And and on structure over the journey Ocaliva that, to our year's focus leverage in this objectives as update early conclude financial the review a regulatory about positioned the of long-term for we Ocaliva the our implementation phase performance with will Andrew an on growth reiterated the updated

Linda Richardson

today. us and Jerry to Thanks, who's thank making time to everyone you join

our first business. significant The performance As a driven you increasing contribution half our foundational posting XXXX. for this press PBC by double remained saw morning, in from of strong, solid business another the and quarter in performance release growth our and digit international sales of was a US the

talk First, let about the US. me

multi-channel You information we received our updated in to a recall, communicating quickly audiences may label using this key and late our approach. May began

is excellent progress prescribers to Our making first that we are top toward goal. existing reach and our priority

research of almost educated market XX% awareness two As we have prescribers indicated a sample today, new the prescribers have thirds of already our survey of label. and existing of our

to Ocaliva we territory, of our our the prior by messaging return driving in effectively of writers of in majority switched territories that growth educated confident feel we have given August. a we'll as gastroenterology be community existing and of branded case we will will anticipate end This on strategy Importantly, all be by course over the setting. a case and basis, the that

patient prescribing gastroenterologists of trends, I generate largely business. just beginning impact new quarter that a of XXXX. we our of see starts in third update on the our the note writers who new expect to the label significant amount US. community Therefore, an see would terms are In to impact now we are in of would new

To As patients for and promotional on to quickly, regarding key and plans to educating to to back see HCP and team look fairly our PBC. longer appropriate who for in some several We our messaging would efforts. cirrhosis. to patients end, have declines pivoting management with rebuilds the see fully brand discontinued them with in we especially this place Ocaliva and our developments of therapy, support patients expect forward Ocaliva no also community decompensated we are

FibroScan by to for look enhanced the First, testing. These extension label health from years late care patients the open highlighting sharing next measured cohort and materials Ocaliva The to to of information changes, using Ocaliva new fibrosis extension open month, have participating forward with and we providers. been six fibrosis label liver data up these as trial. who patients on refreshed deploy data educational the we in plan POISE data include the our in phase remained of

outcome the use according defines population for PBC. remains clearly the US, Second, In of new the Consortium. since the Ocaliva line and elevated significant long-term, not label health the cirrhosis. for therapy attainable a have who still these the risk as time quarters with adding patients have approved for elevated patients for providers for have positioning our the who biochemical patients data of we patient many cirrhotic. treatment we but patients ALP in from agent patients for place only remain approximately We levels information who have Stable Ocaliva PBC are use PBC. with of is discuss regimen eligible over and that second of some There Ocaliva do And growth at continue in will patients to the the and global are especially advanced PBC markers to And been to patient negative we've opportunity simplifies we share a Ocaliva benefits care bilirubin. to believe three treatment non new treat now. less dosing. with majority

including as a to of adoption our and engagement our company Ocaliva our for new for has regions, to sales when we international we exceeding We and ease. restrictions access customers patients quarter saw business, was expectations. prescribers strongest demand focus in excellent the particularly factors, COVID to execution Multi-channel sales in several see force last history. strong us across increased again, driven increased have Moving by This our been and compared start. with institutions year,

regulators discussions regarding post marketing remain Our ongoing. with our commitments

indicated as by FDA contra study, most XXX in included the and advanced patients EMA have are enrollment with label. stop We to PBC, which the agreed patients new now with these the

working steps generating forward We with additional to next trial and are data. for regulatory authorities long-term to COBALT the the ongoing committed look to define

when begins and berry beyond the to as evaluating to to deliver medications provide on data important ultimately Importantly, Michelle our alone fibrosis the turn call pipeline. are effect and over therapies progress outcomes. now demonstrating an field ALP we our regulatory I'd PBC update like to for evolve the positioned Dr. Ocaliva well to bilirubin, on Michelle?

Michelle Berrey

everyone. I'm the was joining the morning good I'll NASH this update today. and regulatory here truly honored begin Linda with for to quarter. you, Thank be team that promised

the We disease an first The due FDA XXX iterative biopsy groundbreaking. process advanced fibrosis progress are treat Intercept NASH, accomplishments interpretation date REGENERATE. the one, from increasing prevalence therapeutic has three database liver accelerated compound the approval to two, and on liver believe inclusion been the of with OCA large pursuing no options. team XX the OCA; for I methodology; with pathway items, improved key by to year to additional have this a month for as biopsies affected safety three and

data OCA analysis. since of the the have doubled NASH interim the we more than initial safety and we have for time First,

Let put in me that perspective.

this potential with specific therapy, alignment significant of events. We've safety XXXX each XX as patients XXXX years of have liver under months of interim analysis of increase reached than data. on of these including off the have the been now in have patients for time approximately with analyzing OCA. For of on XXX patient patients details XXXX to Approximately years had the of the month With a more of median drug contributing patients now XX a FDA just related we plan, adjudication exposure are exposure. data months of cut XX in data. amount XXXX events, median safety four are over the on other We data safety and and well gained analysis as

analyze see and with months, FDA and the coming beginning as of data we're excited we OCAs significant evaluation profile active As fall progress over through we of will NASH, safety part and needed. the to In XXXX. and pursue summary, data in early our dialogue made in the the tolerability we've

moving and preparation compounds the biopsy slide liver of NASH, and need for with Second, methodologies the methodology, increasing investigational number forward center become has issue. reading a standardized in front

take NASH, largest the slide of As us trial the REGENERATE a methodologies critical Phase for interpretation. in to III for is first look at trial it potential OCA and was successful different

and to panel for have independent We The review. guidance draft forward abstract methodologies and review submitted and of driven details a in the been elected has have data our this of an panel Meeting approach move our rationale with three our completed the fall. Liver the the for of pathologists

all We whose pathologists the have methodology reading on standardized consensus consistent. guidance. Three will of interpretations or FDAs the with analyses simultaneously were will fibrosis line the be a their our and draft NASH receive liver in for approach and preparation selected and panel biopsies integrated each using pathologists latest slides

their result For reads first primary from third the If assessment the each on pathologists if that result. is the pathologists the the biopsy, pathologists the tie. two discordant two agree have break

liver reading with our to REGENERATE Because details is and we reading progress agency the and continuing of believe to the liver is methodology, liver begin this ongoing the study, discuss to be new a continued discussions regenerate Although undergo participants from month have all we analyses, biopsies. and multiyear to we have we insight enough because baseline the biopsies month scheduled an trial will XX to XXX biopsies. are

biopsies we is intent biopsies and XX that have over XXXX additional month treat not were included REGENERATE the liver database the in the XX that months an the will analysis, of population. to in bottom So interim line total analysis in then XXX

our biopsy coming internally data NASH into months decisions available XXXX, evaluating liver and be these As making resubmission. in will we data safety driven early on and and the become potential

study OCA patients studying in a underway, Phase cirrhosis. III REVERSE, have We with compensated NASH second also large

endpoint of has approach. now will same all or primary utilizing REVERSE consensus reading utilizing to for a these the happy begun. We for the report that methodology I'm panel reading be Today, biopsies of the

remained data ultimately Jerry accumulate the we active now data far. gathering to data and front of said field by space, As generation. and NASH we this in earlier, We've the in runner evolved generating is The largest have will in the amount feedback from are planning unprecedented. we set

OCA As fibrosis reminder REGENERATE, a results the announced with investigational of a became trial. no first when NASH of we Phase the worsening from in demonstrate III to first positive improvement interim analysis compound

the OCAs US, our only In a is As REGENRATE the produce and risk Phase and meeting short profile. my approval of second time Intercept, data the results Type deeper half submission. feedback the at FDA perspective this new exciting collect we to XXXX, study been and half we on fall. year forward will following and pleased second positive remains enter every an A additional continued with as efficacy in I've into safety III generate NASH with here In I day, interactions focused the agency's last provide we to in that look program on benefit accelerated response data the NASH the of the to progress XXXX.

also we in NASH As fibrosis. you know, submitted an for Europe MAA

requested to continue we analyses. month quarter, with We a extension toward have to stop. reviews and last of data indicated new we regulatory our work received European clock two our the aligning As timing now

generation paused currently progress with through today. really the we as that data activities remains application are Our

survival. our outside improvements Turning bezafibrate reduce published bezafibrate US. plus to biliary alkaline and encouraging bilirubin novel cholangitis potential our associated improved this Phase phosphatase internal the II trial benefit the enrolling are with pipeline, of to Recently combination and and is data elevated for the reinforce supporting OCA currently primary

today in in to of adjusted us earlier, are line years, Autoimmune middle quality women for with Early to that only tend for for for first study their reviewed young substantial on to living diseases also individuals manifest Linda human the of I'm recognized compound As initiated to We XXX. agent we've generation PBC. life in aged as remain Ocaliva productive exciting. agonist second a approved pleased therapies are our as loss use remains they increasingly prime liver PBC. and FXR committed progressing years. next share the drivers this data

this deepen understanding our animal We additional months compounds the coming that model will profile. of expect data over

and Andrew significant now Together, several there embracing Finally, the one diverse finding about I committed the experiences solutions challenges opportunity are to excited need. turn unmet call where diseases have we over for financial we the to and a will of our of to previously liver a to Intercept, shape at Andrew? capabilities update. remains Intercept. new I'm address as future untreated the leverage to faces new skills,

Andrew Saik

good Michelle Thanks pleased on am and morning, everyone. also I very the morning. to the call team this join

net issued financial summary For for reference, earlier today of XX.X I quarter, XX.X would first Ocaliva to this prior worldwide to ask refer of and year performance that million June a that million. recognized XX, release the in quarter XXXX. you compares sales was Beginning our our second results the in with This sales the year. $XX.X quarter this ended of press we for please million period

ex US This Ocaliva approximately Our of year respectively XX% comprised sales of sales XX.X quarter. represents net versus US million of sales million. worldwide of prior are the net and XX.X and XX% growth

Our were during our totaled year US the decrease the last which the exchange million, demand million recognized period. prior country performed also million. and foreign note year was meaning the Non-GAAP normalized a of versus an million expenses on $XX.X operating year. XX.X the basis second for versus credit million decrease second of of XX.X operating were Please tax XX.X global quarter the timing Overall last from by R&D a we $XX.X expenses performance. was quarter, XX.X quarter that adjusted inventory operating that growth quarter, last million adjusted well benefit international GAAP and results over year COVID-XX. solid business, for to Linda the expenses driven related earlier. rates included discussed of In business as increased reflect business mix, changes had a

XXXX. were actions change compensation primarily $X.X to second was sales million quarter, the SG&A to operating period. year $X.X $XX.X versus million of our by the million expenses second the the was expenses depreciation. and in for XX.X for a decrease compared expenses excludes quarter Cost of taken adjusted non-GAAP point operating million of to quarter stock driven relative based second a As reminder, prior prior the The period. reduce

development of Our R&D the period expenses same was driven R&D million in related tax versus the three lower increase in were June in second Normalizing UK primarily The million R&D periods, XX, the by million, recognition last in by year. tax our quarter to XX.X credits XXXX. $XX NASH months lower both credit $X.X costs the for expenses decreased ended approximately R&D reflecting program.

six $X.X representing XXXX, XX, expenses June For months R&D cost. ended R&D NASH expenses with total of the two were at this related million thirds approximately

As and a QX a of positive business our quarter. ever cash the strong we on reported second first higher result performance, ended company's the than position quarter cash

Our cash, totaled debt million. cash June $XXX.X equivalents, and of restricted as securities approximately investment cash XX, XXXX

full reiterating worldwide million the million. $XXX including we XXXX, of Lastly, guidance are our Ocaliva sales for net year $XXX in range to

were and see change above we at its results update to in While trending is to this still time. our are early the our guidance we not strong Because the are impact in our US. are label the sales year-to-date just stages, prepared beginning of now change expectations, label

earlier It We to guidance are also factors reiterating discussed the expense work top NASH strong. incremental Intercept my the the million non-GAAP that operating of Michelle This one of that $XXX in priorities operating the expenses in financially ensure to call. range is million. remains $XXX in in

it have regulatory ensure milestones, and now our to and support I of to questions. expand Operator? execute that, PBC sheet look over With flexibility our for any the on have to operator our the to the like for will business. balance strong we cash growth foundational prudently and We turn to opportunities a utilize our grow business,

Operator

the question Lee Jefferies. Thank you. have first from with [Operator Michael Instructions] We

Your line open. is

Michael Lee

the for and Thanks question Michelle. morning. hear good nice to Hi,

think Michelle. knows I everybody

could just was more and to data going Can that now everything out questions. you there's Intercept. at have at of study. had report baseline reread pivotal scans, clarify, that change, the two data to great it's and going just to you We technically because So months XX analysis on right. the One and you're reread you're the patients

put gets So that just the better type or worse? you're the out? the can data or and stays you is same us question out same on will what tell clarify going of then if play thing. the And it how FX to second just And study, happens,

handicapping you Thank you to think little expect made changes previously, bit you're you. study how that just but that some I a how that result out. about talk to and maybe read

Jerry Durso

Mike, thanks like question. Michelle for the to are happy the you call have on today. Okay I

your to turn we'll questions So her, right think. I

Michelle Berrey

here Yeah, that so voice, hear to your be it's thanks, today. nice really to great

now So our going to first on what the we reads for disclosed the yes, consensus question with are forward your we pathologist. with reread, have

that really the they been really decades, many we we've historically, know, that over questions recommending but pathologist, discordance regulators have on some what guidance, consensus, single relied their didn't from you to about on As raises sometimes pathologists, that heard give in specifics a meant. and draft have

have this gone disclosing our plan, forward details be that and we'll at on fall use pathologists. three Meeting the around independent hopefully We Liver to is which

So primary receiving and their biopsies those answer. the they aligned are we two their first different they the read get the If reads, then from reads breaks then in will slide, on they have pathologist on tie. that's the as will third if simultaneously two be pathologists all we -

a It that's data to consensus. So set. new to plan simply get stated will our the create

new and increases again sensitivity, Meeting. a we'll the at believe methodology, So is details, the one that we into this because Liver the go

be are new implementing we this We are methodology. excited to

So all XXs. we slides the read month to did of the all baseline want

So that's over XXXX biopsies, XX. both month in at and baseline

about on your population. patient the question think was REVERSE about I

any same biopsy patient And we'll those see in that's again did the cadence on used be We through those methodology, of it of that certainly methodology went parallel updating close. we once all a we is are as so changes So get have their month XX really month an XX. on line would But these can't from going FX read specific until to of be what come biopsies, to those some REGENERATE, pretty long the again, how should little be timing expect using guidance, reading the we to for that slides on pathologists get slides. that slides for And population. we'll give that be sight takes to the well. timing the

Michael Lee

Okay, to want as which around clear, for your just kind both out same come would end by the the year of all timing base this case be of time studies. is

Michelle Berrey

you we that on the timing is. until Again, We see guidance pathologist humans. reliant what give with can't really we're on

So again, we their until get with some idea pace.

Jerry Durso

Michelle larger. just to by as we'll is of in REGENERATE reading two We data lot parallel. continue top end obviously to Mike, REVERSE Yeah. year. the be the do a line clarify, indicated, set studies The expect to the see the

insight Michelle as we'll the processor. as However, more the of get through indicated, for little the REGENERATE totality a on those progress time we reads

Michael Lee

you, Thank Perfect. guys.

Jerry Durso

Mike. Thanks

Operator

comes question Fitzgerald. from next Cantor Young Alethia Our with

open. is line Your

Alethia Young

following the first potential so efficacy you would also mean, and thanks my same I probably philosophical exact the a that as doubt I the the with with will would basically review, working be efficacy when that that the being see. guys, Thanks. it considering do previously I kind welcome to all of change is One, faces. benefit And of is question, class just but and that of now along see work asked much Hey, you OCA? FDA of you was taking the then you We kind with just in this an question And new guess it biopsy will feel guys. risk concerns look the new like, through to we is a the for do is possible so you'll on risk? questions. be issue kind versus feel like kind how this of process, - long-term forward

Jerry Durso

one one. mean, progress objective, the Yeah. the there. Alethia, maybe there to out I'll an the is need dual start then on we're the second obviously, continuing Michelle thanks for Maybe I questions. unmet with and first on

we're understanding have intention one to set that to risk data the the benefit that at our as on position So be that a we to as strongest discussion same do meet of regroup the with of best the is moving us forward our that path the possible in of ultimately to time will agency. as objectives need and allow expeditious best unmet - on the have have ensuring here

progressing I the question, make benefit continue the to also of in from the that sight be of bring seen in we've want that that the may is key mean, class, the antifibrotic some we sure first that of compounds we benefit fact we're a that and differentiator think terms to is analysis benefit. In previous a not other believe not I that element potential losing might

So more to come success focused the objective agency dual the ultimate time hand. we once moving here, with can in we same on yes, trying that at stay additional we of of while dialogue important probability as and have the as increase to again of quickly forward but the quality data some that

you was of or some there, can second about color not The whether new question the part or please. the Michelle, maybe method could alter provide give results. new

Michelle Berrey

we be to differentiation significant analysis. clinically from in But see data cohort and these placebo exactly expect the we statistically remember, believe think even did same. significant highly don't I we the interim Yeah. the

by is As we that. more a data pointed lot believe out, across more this getting a are using you read this we panel consistent and

out of taking that the sort some know you get we So with discordance. noise we're of

this basis believe of the set potential give a a we us to will data be So resubmission. stronger

for safety, Just the one this strengthen to set other us large we XXX point on with because forward four benefit will reached risk now that additional assess the have ability going also patients submission. so years over data who've

it we're as sharing comes with So to and to forward in. data guys these out excited look you get

Alethia Young

you. thank Great,

Operator

Sandler. with Rahimi from comes Our next Yasmeen question Piper

is Your line open.

Yasmeen Rahimi

versus and one a point hear two on fibrosis improvement the we discordance into bit taking discordance so could single a think glimpse prevalent understanding my evolution? nice can team, we to us for fibrosis placebo? the little to more evolution, is the contribute thank the and would so three you thank in give more NASH voices. to for the endpoints assessed does differences a reader Hi, question. drill much And you your down of And great How like readers. when NASH you the between When discordance color. about I

Michelle Berrey

talk to nice to you questions, the for thanks so Yeah, today.

into the and So single at analyses submitted specifics on again, go abstract. Meeting. as hopeful, between Liver a again, our we'll reader that's the been difference We're the an

the what that whether using believe we increase So whether behind And a grade. into see like there's by too a can't go more was that or not did these us that's on a fibrosis binary consistent ballooning on that, our outcome, the data, we much gives data but sensitivity. we or read panel do

believe we the set a believe this dataset. more give forward strengthen we this consistent with accelerated go risk data we that one that do will So will us benefit again, as for us and approval assessment

Yasmeen Rahimi

if comment you. question, on just additional are read, may many many are of on I those of Thank the placebo. XXX how a and clarifying And how ask you can drug in biopsies out

Michelle Berrey

additions the the across are arms. three of all the So patients randomized -

So the consistent, initial XXX. that was additional analysis these that's or whether with

and so XXX So for forward these one well. XX it's one to one randomization, a carried as would to placebo XX, that have

Yasmeen Rahimi

Great. Thank you.

Jerry Durso

Thanks Yas.

Operator

question next from with Our comes Goldman Sachs. Richter Salveen

open. is Your line

Unidentified Analyst

read? so your And into understand your you resubmission then potentially, coming understand also, that Hi, you you - us Thank data what thank guess This by taking that could end? fold is I just Will package are REVERSE Salveen. into year Could that much top help expectations line for also next help you. year? would you us question. on our Sonia the for

Jerry Durso

maybe Maybe one. Sonia. can the on second Michelle question Thanks first I'll the start and to get

that been around case, we've the has as the with continues we've year agency primarily this dialogue REGENERATE previously the think dataset. to be I had said, the

read additional And on REVERSE, closer we to be on so discussions we'll that data out as having set. clearly get

have important closer the as and It's expectations? additional as we're to said, set second color data get need the seeing high some to more we guess which I to may about with with continue have be like potential the do important we would for options I in that data. there. I what just get we'll definitely think population. this high a an to we If mean, data to contemporary positive, But think bring study have discussion of part forward the risk was data question set. excited any the on think our is good we'll the I I we to excited. the look I we agency, unmet

Lisa DeFrancesco

think your I So answered questions. that

Unidentified Analyst

Yes. you Thank much. so

Operator

Thank next with you. Skorney Baird. question Brian is from [Operator Instructions] Our

line is Your open.

Brian Skorney

taking for the thank you question. Hey,

methodology that as about analysis going in all, of Just was a that the reading, So utilize when hit is what does a is and opposed biopsy FX being the up - there data up the how I thinking protocol defined to in FX that to protocol in as is REGENERATE, first terms this you're you're that alpha change wind the utilizing this for baseline be primary of in patient consensus FX considered guess, statistics that REVERSE? those any to wind analysis or that? going to can was the FX, and that's then for result And being baseline the will do a primary Thanks. of patients now analysis one?

Jerry Durso

Thanks Brian. Maybe first. the question we'll start on REVERSE

Michelle Berrey

that was And so those are so - rereading we Yeah, was that I biopsies. REGENERATE. thought for

sure make question, make I Just to - I'm Brian. want sure your answering

their we on details who into with the as all of baselines, are rereading very reads But the question change? the did could going pathologists with selected we're and on pathologists. on their I NASH these not there these again, pathologists are fibrosis to reads find of very readings we're think was, consistent how we other steatosis are those go And inflammation. that consistent

methodology. of and important these confident this same reads, any not this are there at require a have baselines If important a so be on all month change. we across So that reading methodology, is the the it That number. there biopsies all to to that are for of analyses, same with XX, now the us differences it's minimum with the did methodology baseline XXXX will have protocol new

our the our about and agreement begin that We with have we have conversations It with them an in agency new are in can statistical been is this again, frequent that reading set. a slides very new plan, and data this analysis specifying with methodology.

not alpha is it an So hit.

basis So be that it will for be resubmission. will new our a set data potential again, the

Brian Skorney

answers. the for thanks Great,

Michelle Berrey

Okay, thanks.

Jerry Durso

Thanks, Brian.

Operator

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

line Your is open.

Brian Abrahams

how And specific their in for expect safety reason issues, like bar on might secondarily, Thanks. gating later original with been in welcome the and interdependencies and biopsy enrolled to has that the some my study been Andrew there discussed? risk? Thanks I the the respect guess to any XXX Congrats the Michelle patients? the you on other talk taking I'm histological a morning. others. about to are you I'm there for impact and FDAs outcomes then re-analysis good more Hey, to questions. any assessment patients and differ could - of Delta additional on that's progress biopsy who endpoints a of the curious, little overall versus the or curious bit if characteristics collection benefit anticipate on the

Jerry Durso

We'll Michelle one. Brian. with on Thanks stick this

Michelle Berrey

to nice No, you talk to hi. today. Yeah,

a the important the we consistent more using So much panel believe across US. thing again, read us this is with

of this closer on we fibrosis, one different and So - with between will panels, we've we of a steatosis we to liver - that get and gets to that is of for liver, again, XX. surrogate in the for that that you known long as you limitations might biopsies, in baseline the us methodology using that. this new these what truth this see some quotes month the believe endpoint, believe us are can new truth methodology and and the two changes and pathologists closer hear But the we're seeing one

question? second The

Lisa DeFrancesco

question. Give second a

Brian Abrahams

you'd curious crop I different? the for reason been of bar discussed, bar endpoints specific patients Delta be histological the any to then on a guess new I need the that might if show a and there's

Michelle Berrey

Yeah.

I believe the have not power. I'm our analysis but you highly may not all will you So would analyses, case, to then think that's if back powered original there the recall, is significant detect the part population That we I of assumptions. clinically but in you a new what don't study we approval. happy accelerated get even interim and is set analysis exploratory that additional to patients, statistical some our can potentially believe XXX the the supporting patients. part the data XXX is with these previously. been that believe stronger be disclosed the that from of see was phases with they're that'll this original patients I a very has FX, And statistics Delta. and additional much statistically say FX were both of those Again, FX, primary are that be

Brian Abrahams

Michelle. Thanks

Operator

Our Cowen Ritu and next with from Baral comes question Company.

Your line open. is

Anvita Gupta

Congrats is on quarter. the Ritu. for on this Anvita Hi,

Just from questions us. two

obtained resubmission? the So our firstly, will And for just to off for secondly, definite that the data questions. alignment Thanks confirm, cut the taking be a the safety resubmission? what you for needed is have with FDA for the

Jerry Durso

Okay, FDA can these as enough considerable in of the you think in as I data think the generate dialogue It's sets large call I'll heard forward with - we the maybe first can a insight you question, on one talking now and been to about. back. come the year-to-date, amount then we're start the and I have today, we move

as the align think agreement approach biopsies And to feel the we good that of that we read safety start the good with update. I indicated have on that we details the we Michelle proposed. to

submission. data generate advance Of going in the once pre-submission to next of what important potential a and to the discuss the it's data, we potential course, depending the we on then agency with see together an in the be data, step, get and

in pre-submission based the are we'll if that provide that's work in that progress do it happens Thanks, the updates half first through way morning. XXXX. about do to of this as would meeting, Anvita. the outlined So to where the continue And be we work believe on We the think we we've process. that we

Lisa DeFrancesco

question? Next

Operator

with next Our question is Luchini from BMO. Matthew

Your open. line is

Unidentified Analyst

the maintain spread quarter? that. And to that all the is you a on be to you have that reverse what taking you to expect our guidance? the Is given going quarter that up Jen third going second Could is more this Matt, for second Or half? guys like be over I going to provide drove going and color forward it Hey, the guide on thanks follow Hello. after how questions.

Jerry Durso

what we I how in feel million, quarter to can looking Ocaliva. some that for the do the give thanks context go at at perhaps of the about second happened year guidance we to sales Andrew, on good reported with Okay, mean, point. we're the the $XX this in question. you insight roughly the

Andrew Saik

the Sure. look, in happy Thanks XX million. was The international the business and again, with Yeah, Jerry. US really both performance terrific.

change impacts have reason the the think guidance label been of that numbers, the seen of the for the yet not the I in is reiteration simply right.

by label the So change. second quarter the was unimpacted

that expect when. in. specific guidance think going on quarter We I to don't want to to come which hit it's we and give

expect six that again we growing impact three see call months it at until it last point. We to and the to start hopefully

just appropriate big a mark not was have we such really, seems we the And reason for to So And change the it reiteration the time that simply don't there. out know. guidance. question

Jerry Durso

might impacted only good size who group we XX-ish example, contraindication talk a XX% that of now potential that be the falls And the the of label will label I quarter, Yeah, estimate into patients range, still color we about of range particularly of with the by add roughly for that update. that be label. outside I a believe change, the guess to population that's now the the did last patient is might additional the

be looking one that as Andrew future at the the that's So we'll the when we potential providing impact of said. at monitoring look in dimensions and updates again,

Unidentified Analyst

on regenerate analyzing prospective that you you've are that post here? - reads? of from reset data the details the then sort new implementing are data, little are guys Or more Provide be following And like you guys data believe AASLD. biopsy bit is of bar you a phase disclosing expecting going guys can efficacy I not the helpful. to right. Okay, just we what the a is be

Michelle Berrey

and will analyses yet the we'll share but if we Meeting what we do able again, that an conducted. so Right, be have we accepted, and hopeful at to that's Liver we know hopefully are be submitted the abstract going we don't

the methodologies a a excited we'll superior rationale we the a panel chose our historical standard So we to work rationale data really Liver we'll that do results, analyses we that did those these for looking from acceptable the to are - panel that we're is of at into we Meeting. runner, as go have on behind But as barrier front at the the believe for about point kind us analyses approach. of those to we strengthen a And for single been XXs different methodology. go Again, methodology that come why the consensus going the FDA. some earlier a set. back decades both are that that to we into looking this at to using month data months. won't new this something and will has all know. was it coming the was in Again, did, we read, over and as which our Compared show you baselines the felt incumbent do these Again, the gold as why

is We difference. strongly the this that able study, talked we that power And again, study to it have powered the say not to be - a about, detect except of to in smaller final was conducted that. saw when that we we disclose again, those certainly excited seeing that data data. set significance back about We'll in so XXXX, have the even statistical

Unidentified Analyst

the is not Right reads and type Or guys then you with are to be basis. that disclosing new going or perspective post yet?

Michelle Berrey

I sure understand there. the Not question

month at and data additional those patients month looking as XXX come they in, baselines reached both XX. are the and those adding We XXs we have the as are

the may over be question. then think those your I be understanding not in data will coming months, coming

Unidentified Analyst

Thanks all question. Okay, right. for taking our

Michelle Berrey

Sure.

Operator

with Our next question comes from Oppenheimer. Olson Jay

Your line is open.

Jay Olson

we not question. discordance the biopsy person biased three you comment taking consensus you cash about the should randomly the or that's single direction? between whether Or you talk the you. and Thank can future And And a systematically and the whether reaching not distributed? in my is is in to reader quarters? on discordance Can timeline thank panel positivity, then expect a that goal update. that And one you or for to flow Thank on that profitability the priority? see is for

Jerry Durso

take question first second with Maybe Jay. Thanks Andrew. we'll the

Andrew Saik

Yeah, question. the no, thanks for

of and in next end. given but that negative impact expect to to in we two had that, the label potential on spending we profitable Obviously, quarter for when in company. past with And normal the change get and cash looking on this the NASH. we're we the haven't Of next we'll that do the year we're the not long-term guiding the We're continued go quarters We course, that in guidance going delighted be company course ever first and to would couple we're positive quarters. revenue a to year.

Michelle Berrey

your think single interesting guess watch thing I it even second And generated. on has question, Again, the was the share space to But I well, that decades one that is within a many over, pathologist. we'll in with first pathologist. that the question again, been the we've data discordance discordance on

believe issues and can do we issues reads or that in see that a our and biopsies, share why the of we'll this presentation pathologist and really data a improves Meeting. single give of the - we the we reread Liver methodology address at data break this the pushed to with drift this those we of many are with one two with believe and We sets reader panel the until of we changes that pathologists. on reading. the some that you us you single with avoids for where improves accuracy over see the how that's So or they're where approach see see that And the get some seen time we sensitivity, all don't embargo that any details can't and do more on

Jay Olson

taking Okay, questions. for great. Thanks the

Jerry Durso

Thanks Jay.

Operator

James. Our next Steve with question Seedhouse Raymond comes from

open. line Your is

Steve Seedhouse

in data month And you're resolution through I NASH Good XXX really a be you will and one package, guys. just XX. to primary thanks have then if if on Great, improvement. - two the role endpoints improvement resubmission a Didn't mentioned patients outcomes or data are the there going rereads, of you'll mention fibrosis clarify hear fibrosis to just any resubmission. for on biopsy wanted morning. there

will be you. crystal So data on to be or month including those reviews. biopsies to clear whether resubmission data FDA of part blinded a Thank I or that not Intercept wanted XX outcomes just

Michelle Berrey

your the primary of so worsening Yeah, so it first or endpoint, with steatosis question is steatosis worsening on on without resolution fibrosis. no in of of fibrosis, improvement

that are So there combined for are US. in And the manner. endpoints endpoint then a hierarchical that that's primary multiple read secondary all

package. of will that primary, in data of the approval largest coming that's the course, generating the they NASH we months, a additional that be looking we the if of package we again, and of patients will and statistical the generated. excited submission, through secondaries. over amount the is created that be large because large, get that again, you And that. And will to move very our largest be So hit then date to on set to It we're those XXXX. And all number significance basis of are data accelerated will in be hope

of On XX approval. outcomes, outcomes and the the full month clinical again, be would a that basis

analyzing outcomes accelerated baseline we approval the not So approval, part that biopsies, would the a month are preservation, at term XX again, down XX month benefit, full is of point. be which at month, as something and analyzed the that's line. clinical focused this on We're XX fibrosis longer the an that looking that

Steve Seedhouse

So there answer, up an Can regenerate. you function this resolution it is the might I confusion an there was think course because more over of answers? first is just in based mentioned follow and I on add and there anything on endpoint that's the of or of steatosis your changed

can the So if fibrosis? NASH fibrosis you Or separate primary primary one you being the hit being just are endpoint? in without or worsening one hitting you clarify second other NASH, without of two resolution the endpoints of improvement worsening other,

Michelle Berrey

Correct.

and that, latter, the then secondary an to it primary on then you endpoints. those isn't the move can with or So

things working of that to see. of the So make confusing with this again, to on regulators yes, they we're set a that is the analyses, all sure it want very demonstrating

consistent It at wouldn't And steatosis, do addressed also have you that's for of or those components so alignment most endpoint. impacting of fibrosis, endpoints, these or mostly without the steatosis think of and why resolution if is across that aspect we that's us the but and primary Europe. have additional of to we inflammation that. going be surprise, have look in are is improvement that fibrosis in I secondary they that to important those important US

Steve Seedhouse

much. so Thanks

Operator

Smith And with from SVB Leerink. question comes our next Thomas

Your open. line is

Thomas Smith

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

what set you've events. including safety using genesis and for the FDA is was guess coming liver color more are a histology you it these Just Thanks. how wondering of the adjudication the similar a to on I I the consensus Can you reached lineup expanded think it with on us alignment Michelle, the give data the being methodology, just endpoints and adjudication. on little evaluated, analyses. for events, mentioned is safety you

Michelle Berrey

Yeah. No. Tom. Hi,

different anything for studies. is interest independent of So out it's in used have one think who have three blinded interest a where groups other is about right. reviewing I it's the for good an are us. really of group adjudication of clinicians question. And are The adjudication don't this. panels cases There high to certainly these having you large FDA, and the organ of the that ordinary particular, was

areas. interest liver et for Not just reviewing So progression of of important disease that's is clinician was the for it - the particularly disease, the our why have to narratives of group liver an these independent it is in to renal the cetera. of so liver or liver, increased therapeutic all

this sent it them group this is So group. which was and pretty with adjudication about on just would alignment standard a the getting cases be to independent

Thomas Smith

it. Got

panel? what's and liver, the on the third up you Okay. Michelle, follow renal just I And guess, that mentioned

Michelle Berrey

cardiovascular. In

Thomas Smith

cardiovascular. In

Okay, the questions. great. Thanks for taking

Michelle Berrey

Absolutely.

Jerry Durso

Thanks Tom.

Operator

you. Thank

next from Securities. Our question JMP is with Jon Wolleben

Your is line open.

Jon Wolleben

good Hey, morning, question. thanks the and taking for

recent has reanalysis wondering was Just that's you're with right if get patients I'm in wondering we Ocaliva the making that conversation if segment. interactions. the about previously sure conversation revisited the identifying the when have the to that's part of of to changed NASH something and Or going biopsies? these right be able

Jerry Durso

data important in that in the discussion regroup in the of some about best hand considerations right be think thinking potentially position I markets. population, about to with the we'll Jon, on Yeah. that the

in data then So the important position will those I step generation next think all to better be the again, outlined is questions a you have.

Jon Wolleben

Got Thanks. it.

Operator

remarks. to our would to their And I Q&A for turn management Thank final this you. it back ends session. like

Jerry Durso

Thanks. our year. perspective, progress From And this for thanks so far today. us my perspective, great for everybody joining

leadership to new important place, going us which team moving importantly, ahead. think, I definitely in help is the do work we

label in strong and the Secondly, long-term to our now - on completed our strategy. update our global quarter. delivered PBC definitely focusing the business back US another We

productive As NASH the the with on FDA had interactions side. you we've heard,

the execution the and NASH that certainly move pipeline. progress can't we stay in be will And the insight making products We'll forward as what out on And the we we're and read field on move by have to to key data fact in be drive our to the REVERSE of year. we forget the generate the the to the this decision package of end needed focused ahead. other pipeline. making internal data largest will that We now

least, the So side providing half definitely will want I of regulatory during the be busy the the go forward continuing Intercept clinical side, the on second for important look updates not on to to and going patients with area. to period serve through, side the And on we're work, complete dedication the continue to you commercial and what thank all the at done year. that that last in to certainly team they this to and have do we another

hope along and the talk thanks way. we'll So

Operator

you conference And disconnect. you call. this for Thank concludes now today's and participation your may

Intercept Pharmaceuticals (ICPT) 29 Jul 212021 Q2 Earnings call transcript