Intercept Pharmaceuticals (ICPT) 2 Aug 232023 Q2 Earnings call transcript

Company Profile

Participants

Nareg Sagherian	Executive Director, Investor Relations
Jerry Durso	President and CEO
Andrew Saik	Chief Financial Officer
Linda Richardson	Chief Commercial Officer
Michelle Berrey	President, Research & Development and Chief Medical Officer
Yasmeen Rahimi	Piper Sandler
Mayank Mamtani	B. Riley Securities
Ed Arce	H.C. Wainwright
Brian Abrahams	RBC Capital Markets
Jay Olson	Oppenheimer
Jon Wolleben	JMP Securities
Thomas Smith	Leerink Partners
Eliana Merle	UBS
Ryan Deschner	Raymond James
Ritu Baral	Cowen
Matthew Dellatorre	Goldman Sachs

Call transcript

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Operator

Hello, and thank you for standing by. Welcome to Intercept Pharmaceuticals Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions]

to conference like speaker to now Sagherian. Nareg would turn over the your I begin. may you Sir,

Nareg Sagherian

Good you financial and review business morning thank Intercept's call on updates. second to today's quarter XXXX results key for and joining us

second are on slides our and pharma.com. now intercept quarter XXXX at Our release accompanying press website

our product like regulatory begin making statements including forward-looking I'd that prospects, and development our certain to strategy, approved program, clinical we and and Before and discussion, call guidance during matters statements, performance. regarding note financial our future we be financial our will commercial

reliance Listeners be as these number are based are subject law. reasonable, cautioned this no not to risks to and date statements estimates and to the a on uncertainties. update statements, place call, only by that, undue except speak to forward-looking we although required believed undertake on are obligation These which statements of of assumptions uncertain and forward-looking inherently of such as and

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

and Today's and CEO, Chief Berrey. Financial Research our Officer, our Chief begin Commercial and Michelle prepared Andrew Medical Dr. Officer, President call Development will Jerry remarks of from President Saik; with Officer, and Durso; Chief Linda Richardson;

questions. the for open then call will We

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

Jerry Durso

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

of the performance agent outcomes the well, strong sales commercial share patient preferred value market XX% fourth team well than and as as net and the physician performed and that prior PBC as business. world million sales over on execution more positive hepatologists quarter. analysis for Ocaliva's expand. sustained was and place our for Ocaliva of is real quarter, outlook continues consecutive growth This years year role in gastroenterologists the Ocaliva $XX.X second our the result the In and on Linda in in double-digit Ocaliva dynamics again experience trust a business quarter. data growth to outstanding The more seven second in driving growth, the PBC With a line positive the multiple Ocaliva. our about improvement delivering will

Turning pipeline. to our

from prioritize in combination investment We X two program pleased OCA to were Phase our past June. of EASL to bezafibrate data this at combination's We studies continue illustrate data the biochemical best-in-class forward predict in from across Congress a to and the have at our range for to request These with share potential PBC. first positive the of XXXX sharing responses this meeting PBC. all outcomes the data details that We to a of program and look to end in FDA. Phase clinical necessary an biomarkers X submit expect improved the deliver more

restructure diseases, aggressively we are plan profitability serious and that to the on focus deliver quickly. Finally, and rare communicated June business, our XX strengthen on liver we our implementing

meet our to reductions We have targeted expect investment and operating related discontinued in Nash fully all expenses.

in evolving shortly. detail making are in progress reducing our rapid progress our basis. more organization in discuss will cost We Andrew our

improve while XXXX. meaningful Intercept for believe made are growth our business, in supporting best The long-term create position drive profitability new develop and and ability now the in achieve innovative the for value which patient-driven puts well our have actions, leadership to shift we medicines, shareholders, that We will to mission. our PBC underway,

turn now to the Andrew. that, With call over I'll

Andrew Saik

and organizational announced restructuring Jerry, on Thank in morning, reduction good you, I update we will June. everyone. cost our begin and with an that efforts

the and to These cost significantly support at diseases. and of investments related and on Nash size aimed is structure will flexibility work this which by company reducing rare provide to the all we liver us discussed, previously reducing with our As our will long-term take to our discontinuing our strategic forward. us actions as growth by profitability help pivot company allow ensure year-end, serious focus

study to end REGENERATE of the be underway well for by process is the complete expected is substantially and this closeout The year.

to is contributor have the related throughout some We quarter removal announcement, stopped of other all move from sites shut operating ability Since expect XXXX. year-end of costs to clinical quickly spend and by toward we to extending have profitability The these our down company. the an all activities spending important final our restructuring possible. expenses into with as first NASH as our

first of our we and completed commercial impacted general workforce, which have administrative wave functions. With reducing notifications, regard the to

and impact wave finished R&D second this materially functions in medical next affairs be the The a of by weeks the reorganization few of be end year. notifications, and the will will will completed which

stated of the growth we scale previously the maintain sales to support As Ocaliva. current our field organization plan of to

includes to one-time guidance to NASH This respect to to the guidance adjusted $XXX well to related study all in expenses and With charges down OpEx million. we this non-GAAP workforce other $XXX year, as activity, estimated REGENERATE as operating June, our for wind expenses million related XXXX lowered reduction.

grow of As a cost we lower structure run current and are PBC after changes restructuring the expect activities to than and franchise in be achieve with a position profitability complete, in our these a to our XXXX significantly rate. to meaningful result

$XXX in non-GAAP reduction adjusted targeting expenses relative annual expense million operating updated operating net adjusted of approximately Specifically, our a we to guidance. are XXXX non-GAAP

closeout the be effective structure the restructurings of completion new XXXX. complete Our to expected is materially by be will the end of study, of on which REGENERATE cost and

and guidance of $XXX our $XXX to million. to full-year range the million to updated Ocaliva XXXX have our sales net Turning revenue, we raising are lower-end guidance

we year net are for growth million quarter sales, in consecutive recording strong with pleased to double-digit our our the growth. performance this Ocaliva, mentioned, $XX.X with as million in quarter. Jerry XX% sales represents As $XX.X compared This quarter fourth prior

spending, year administrative been now of our in removed quarter. $XX.X prior NASH-related primarily $XX were the and which QX with expenses increase expense general has The second in from in quarter was million compared Selling, base. the driven by XXXX, million

debt a direct expense from interest period year same result the million the to ended taken the XXth, our $X.X down during As quarter last balance was reduce in last million, of our XXXX year. outstanding sheet strengthen $X.X actions June and

reported the a operations XXXX, million $XX.X from of second quarter loss We of to million of continuing operations $X.X the decrease of quarter net second net from in compared a XXXX. continuing a loss in

of cash, approximately company As restricted XXXX, positive and of securities $XX had and cash the equivalents, June Intercept sale was million, for net available by XXth, cash investment million. $XXX cash

principal matured $XXX.X of cash due a we As and on Xst, previously repayment million. XXXX disclosed, convertible made July notes the the total for amount

summary more the financial press I our second results you encourage June look at a of ended detailed our XXXX. For quarter XXth to release for

quarter Intercept strong meaningful and in Both underlying I’m proud financial and to of the factors profitability important are ability company. closing performance of XXXX. of foundation achieve In our this reshape enablers those a our of

turn now Linda. call over will I the to

Linda Richardson

morning, everyone. Good

Andrew in As performance XX% to Ocaliva second increase, noted, reported this the $XX.X quarter, the net strong. of commercial representing Jerry and have a very last million period our sales quarter was year. We in same compared

growth. double-digit our factors Several driving sales repeated are

first we First, attract new to time Ocaliva writers. continue

writers. XX of quarter second new prescribers out Ocaliva XXXX five the first-time were of Specifically patients in of

continue to we see Second, volume growth.

all-time reported resonate IQVIA's time during field period, Clearly, PBC to high that Prescription this monthly sales same messages New as force prescribers. Audit. prescriptions our National demand. grew brand the and by nearly reached delivering is during quarter, And XX% unit with an we

the approximately This show on-time These community XX%. prescriber our on continue as important our for refill a to patients, field the business. therapeutic our of as Interconnect by options to that with patients reimbursement will ground factors new from test be programs and dynamic drivers, specialty we base new rate in well valuable and future. team. expand established strong Among the continue even Ocaliva our These maintain add driven pharmacy support is manager network to capabilities potential we with

research insights from for to satisfied provide Ocaliva with satisfaction to high Ocaliva prescriber support I'd the recent feedback in with approximately that satisfied patient market their XX% like on Recent new remains that extremely now in of therapy. and confidence future PBC. being our shows patient share

Interconnect, patient still enrolled XX% patients expected support that XX% indicated XX-months. of and Ocaliva Ocaliva on program, We were also continue they that in found on at to our

in three Ocaliva enrolled approximately background, and four important patients are As Interconnect.

customer demonstrate products Ocaliva. satisfied patients And three potential to months who multiple persistency therapies. line at for options. new better are through taking in with, dyslipidemia, with stroke chronic belief This of Ocaliva. typically with by diabetes, high data despite for we satisfaction are notably their disease two in is inclined and know Persistency statins, levels This that supported cases, patients therapy years. Ocaliva from includes analogs intervals some prevention These is in remain the insights for on than for it, and

scientific an recent risk one of time select target be patient platforms a levels that key presentations, amount emphasize transplant above promotional incremental hepatic highlight our of the liver PBC biomarkers liver Moving which to leads or and to death. decompensation remains will for of forward,

the impact In will GGT, AST, total and bilirubin. emphasize biomarkers, the these totality XXXX, Ocaliva's of ALT, on of we second-half such as additional

in one our same health important to PBC ALP just biomarkers, monitored. which an that but of presentation, beneficial these As contribute all factor is liver management, be cited corporate on health. in total elements a has Ocaliva of several of assessing impact liver should total

from long-term progression world slow HCP Of and preventing and In XX% survey the Real therapy. in patients study, ability another of term disease evidence progression Ocaliva's matters shown help outcomes. the PBC complications what most avoid market attributes important liver has disease that most of are research are current PBC course, approximately longer avoiding disease complications. stated a to

versus this world of evidence In benefits create Ocaliva our appropriate strategy avenues differentiator show to long-term this competitors is real datasets demonstrate important PBC unique fact, future the improved are and the of now world there real independent use and of Ocaliva. an five of survival. greater supporting that awareness part to Utilizing

momentum strength drive position in The adoption business stability growing today durability confident PBC commercial Building Ocaliva. XXXX, our that ability of and market continue of of first-half our Ocaliva's of review the our and team's I the to and illustrates franchise. in data the the plans am our on further I base to

over the for I'll our clinical amplified Dr. turn is in OCA-bezafibrate Michelle Combination Program. how and PBC call opportunity regulatory by Berrey updates, including long-term now to our

Michelle Berrey

know vital the data these possible, real clinical potential program with remission analyses to Early outcomes is demonstrated PBC achieving in half with from bezafibrate and taking that world X that OCA combination and bezafibrate shown clinical believe benefits. free, transplant combination Linda, everyone. morning, the free improved, been on goals most and best-in-class start Outcomes our remain have in update establish We to decompensation that which I'll multiple in patients in chemical program, PBC to the with you, of the potential progression the Phase have Ocaliva. OCA important offers patients treatment survival. Thank than an good from prevent we more and of future.

two Phase have range exploring We a for therapeutic this doses combination. of X studies

We a milligrams have enrollment effective markers studies rate and with in at EASL initial first PBC completed which both study, of encouraged from now data, associated of damage. these normalizing XXX was combination our very the planned interim induced of XXX show Vienna. We're by of key data have shared specified in that and OCA Study biochemical liver analysis

achieved data Most patients XX% PBC. and is believe of demonstrate higher that which GGT. for between in PPAR agonists, synergy of this potential and that biochemical agonists remission, in reframe in FXR was AST, bilirubin, could the patients efficacy These nearly significant ALT, biomarkers, parameters compelling AFP, arm we saw normalization all key total the the dose group combination

studies as Analyses the from will the an large our to in X of Phase end X X Phase Phase for FDA. preclinical addition with both basis serve data and of study meeting our

hand in We from a have look Phase X to second to XXX, submit request this in sharing to the meeting. XXXX for expect study, important this program interim later year. analysis We including more Study this information forward planned about our data

Ocaliva. to now Turning

as FDA, in post-marketing the evidence in likely track communicated will the sets data, supplementary of remain U.S. study primary year the for on as previously FDAs post evaluation, world As This which be from submission marketing for requirements. Europe. data submission this real with our we COBALT, our an a large well sNDA fulfilling from and support basis alignment and include will

we've a previously, well-known a was believe As due discussed PBC. reflects controlled to flawed a provide study group history feasibility we that of challenges, did natural not COBALT placebo that and

draft in all sets of were FDA's real requirements accordance data Our issued specified with the analyses completed by guidance. world

and Importantly, PBC improvement in decompensation survival label believe these that guidance free risk in positive goals, the with and transplant consistent reflects our analyses We a current a population and for ultimate demonstrate free patients treatment. benefit PBC. the

agency. post-marketing engaged commitments FDA with to committed our regarding the with and are We have working been the

earlier severe within known Finally, associated stage hepatitis, study, our with as FAH. our evaluating we in alcohol progress proof-of-concept pipeline, also fresh XXX continue to patients

in and ascending in of sharing the advances. by in as We updates tolerability We program safety preclinical demonstrated efficacy the and dose forward multiple single to INT-XXX are as study. first this encouraged look and additional our assessments human

our In closing, to back being made I'm R&D I'll progress proud group. turn With by of the Jerry. that,

Jerry Durso

Thank you, Michelle.

For Ocaliva. consecutive quarter, double-digit Intercept the strong sales for fourth delivered growth

We combination performance in best-in-class data and serious along while as potential program, OCA diseases. restructuring on liver also bezafibrate This advancing make that profitability, achieving Intercept in progress toward the presenting suggests quickly leadership exceptional well considerable with reduce with plan to rare significantly our costs, new PBC. the way our including

now to I’ll turn over Operator? it operator for questions. the

Operator

Difficulty] question from Instructions] Our of first Sandler. [Operator comes Difficulty] the line Thank [Technical [Technical you. Piper

Yasmeen Rahimi

so much the Thank update. team. morning, Good for you

more as the little to regards guys FDA are are the X dose about, your you end maybe with development. wanted fixed what expedite, you X opportunity the understand Just there to meeting in having combo? bit Is know, of outcomes a possible an the to Phase Phase

be Just of thinking back you hear more get will how the I'll months, for communication what follow-up. color And we coming over around best a discussion? maybe jump about us -- into thank but again. a queue know sort love sort know, that will don't And the of walk the should we'd what we scenario. I case And be could we to scenarios? And be next that you that through,

Jerry Durso

accumulation More color to on our for outlined. prepared set the Good data X. a Phase with and data Michelle come, from little combinations we're encouraged good give looking on from the to the Obviously, around initial Michelle, Thanks opportunity maybe you can as Yasmeen. Yes, thus what morning, the far by get remarks, of question. seen we’ve more at the end the how morning. those we're agency

Michelle Berrey

and good Yas. morning, yes. Sure, Thanks,

from to X and from as analyses PK Phase drug-drug we have interaction interim So data our pulled XXX. the do of well study, and as plan planned data all the from in large XXX the

biochemistries, some those know, lipids for As safety we're and you we're looking at parameters, patients. at looking including key tolerability

design can the X Phase meeting, for alignment a proposed end do Phase of and plan have we agency hope that to into X we The X with come we during Phase the that meeting.

we’re soon as to get design enrollment We identify sites, that so them off for have XXXX. that begun preparations already study making in we as finalized, and running

explore very combination. this about excited So opportunity to the

have far we agency we're the initial given all conversations the for for anticipate endpoints based what seen high We forward thinking a what so the about X, about what be expected had that this X, in what discussions. Phase are on potential looking with in Clearly, expectations to and may we're they combination we've those seeing endpoint. Phase

Yasmeen Rahimi

the much, back so into I'll you Thank team. jump queue.

Operator

you. next Thank our Please for standby question.

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

open. is line Your

Mayank Mamtani

Thanks taking team. morning strong Good on and questions the quarter. for my congrats

and things comment like how might hoping quick X studying financials. we're VAS, the have incorporated. endpoints like I beza if were then PBC know, And measuring NRS, pruritus, you you a be on protocols, their follow-up the core, Phase we So that OCA you'd

Jerry Durso

take one, you and then on sure with and Michelle I. the first I'm financials we'll Hey, take follow-up Andrew the the

Michelle Berrey

Yes, thanks morning the question. for good for and the --

monotherapy trials we and some So combination. trials, assessments have conducted incorporating the the comparability as that XXX of across, different so we in are our the a do XXX, of yes, well couple prior as in

of at the So term analysis, as planned EASL. studies, that we from those from interim to the at XXX as data well longer XX-weeks we data study shared from the study, XXX, forward look sharing both the the

Mayank Mamtani

you revenue approvals penetration submission then between, PBC how you contribution you year. think you the an and approval, guys or of on know, expecting to know, in the know, maybe -- should drivers of next about growth here outcome full around next I think you year? full outcome to, do you know, to there growth great. you sNDA this. persistence Are know, an How characterize business sort of your have and versus PBC expected, Okay, you be be PBC, do this, missed you related And there as you growth

Jerry Durso

start So about I more -- little we that with and a the maybe then bit will growth. I'll describe can

So, reasonable be It the process. expect we in could a could AdCom an option.

it specific submission the that had that commentary be, insight have and be the we goes the but unforeseen could agency We get haven't that in we'll any agency, on dialogue. wouldn't more from obviously could for, on that more directly ask there that, of AdCom that an but once

Linda the question, continue are that we out guidance if I physicians we we that believe, that It growth mentioned the with good generation quarter that on was patients I in level utilization any demand to that, as demand, with terms so of Mayank, of more and remarks, revision growth, that, her think which and to the Ocaliva the unit overall, underlying I prepared clearly one, see underneath. expect in prescription time. made is we quarter, at continue, sales than and understood good your more growth of of by reported our largest encouraged On given this our growth

encouraged patients see ensuring prepared continuing really, range remarks, chronic really journey, did keep we're both discussion focus them the that as of doing. well. lot while with stay patients everything on to with least a the do work we're and -- include And we that while to see analog new And doing some there's the around some sides ones medications happens in on, the at what dropout, on. expanding of again, would we do in we're you Ocaliva it's on that patients are we And high, can that and on therapy, on the on expect satisfaction we as we to is are

typically kind anti-diabetic picture good like chronic are at over considered, thought you that for adherence about that looking that, think Some drugs of that statins, adherence medication, of we're the to was we comparison of like how time. useful

Mayank Mamtani

Great. Thanks questions. for our taking

Jerry Durso

Thanks, Mayank.

Operator

Please standby our question. for you. Thank next

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

open. is line Your

Ed Arce

and of A couple Good questions Great, strong congrats thank you. me. on morning, quarter. the from

First, I just clarify, wanted combination. to OCA-bezafibrate on the

Firstly, terms the are with it's Could that prior couple of mentioned or and different just you on before, else you NRS what your own studies? in measurements data expand comparability those a pruritus of measurements. something other if

just nine wondering XX% Thanks. then out that XX And a remission, And that of XX? out then complete or I to came have secondly, on how you number. of eight the Is follow-up.

Jerry Durso

Michelle?

Michelle Berrey

Hi, yes. Good Ed. morning,

We of adjustment using in are VAS the the pruritus.

We pruritus, are additional also, believe, excluding in to on were that have those XX, we double trials that will other I was I consistent an close and with with severe all I large of PBC nine patients space. patients, out pull The across have to mention the three measures. normalization. check very up XX, who

I patients, So again, full the from over sets as have, interim those from of in meeting look well data time the as, the the for them in year. data our well think, patients to a all analysis, XXX versus bringing the are the at planned end then should remaining XXX, forward in from those data X hand half and larger we the and to small analysis both we of -- Phase request set

Ed Arce

the later data. so year, that and XXX further ASLD? medical recognize, for possible it These granularity you meeting a and to such have Thank the perhaps is timing, at XXX get longer and you term much. with this analyses, would XXX, then, Great. interim Thank on as studies I any

Michelle Berrey

this as minimum we able it's data present all opportunity where later data. we'll the Certainly, that can't the with as be be at longer will as be I from definitively but hard some study, sharing a term a say line that from great in well to top we're say, assurity to those would year, together data.

the XX, now in patients. given out, ago from study, was more As for XX-months you for we have point of initiated than majority XXX of the patients that XX-months, data about it many the

Ed Arce

Great. Thank you.

Michelle Berrey

Thank you.

Jerry Durso

Thanks, Ed.

Operator

question. Thank you. standby for Please our next

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

open. Your line is

Brian Abrahams

you're if curious play market the commercial out strategy Hey, through thinking to a PBC OCA really would really taking be, Maybe guys. if your drop market the of could entrants. is therapy? that for Linda, be to of going there's you expect ones, to about Wondering new research any suggesting questions. be new Good naturally the walk morning. dynamics patients, with Thanks you us if trying my who if kind for how or off who your would changes potential

think potential then for Thanks. most to the any world And do support to you'll market data the Ocaliva's real use maintenance on PBC? Michelle, the maybe to what's important in skepticism you that around things FDA combat of need

Jerry Durso

Okay.

Brian, we'll in. say, with So deep work that, we're you the start Linda that commercial on as

Linda Richardson

Yes.

thanks the good and So morning. for question

we're marketplace. think seeing that things important what really the I are several in

that's advantages We the first, looked that. are overall probably And at have board. done I PVBC XX% increase to touch confident patients analog that treatment. about across XX% can that we to expect grow. and market on. we competitive But And in overall some anticipating receiving would PBC the certain We've a the are number great of work we

to also everyone. what emergence This of believe that, efficacy we'll necessarily no be we're is evident, even to see and third with be product no be market. going one that because rates right the there product is one will for an rates seeing, line In we

satisfaction the on move from is before. market believe line and research that patients market through patient scores folks strongly the expect to high that be paradigm, a also majority willingness additional if of we've that persistency And showed and So third a and our an this existing begins. be satisfaction we data express and satisfaction directly, there'll patients on will asking rate that to therapy by the therapy. patient stay We supported

driving in continue talk on talk expect and about we uniquely things an efficacy by different we'll efficacy new biomarkers, those to emerging increasing evidence, the we as of we that that and the prescribers We the to patients data organization. third, awareness the see about new real So continue the five have. world

the incumbency continue leverageable the able we and look that across our a has force phenomenal have be job, that drive this we'll we sales believe board, moments particularly to And to to done of quarter. but we lastly, established then And expertise existing and those four secure think I HEP our are have well we our will GI help Those with things and community. at specialty the relationships things totality network that our expanding business. that's established

Jerry Durso

Michelle?

Michelle Berrey

Yes.

the things think over helpful evidence, are that’s to the real following will of and to world guidance the interacting standard agency three in that I The the of that moving three data, So draft a think care. are going which issued be FDA, the to things been make by we specifics. those I with the the advocacy on evolution big replication of difference are the and addition

the fully So or with we the database liver and decreased HEROES, progression benefit, a replication the initially which PBC PBC registries, -- both which world analyses pointed open label across XX% U.K. claims was extension, as first, transplant we have global to patient showed death. of now, which the Komodo call analysis, real Linda which out risk in poise benefit multiple superimposable compared a of seen the datasets, with

is And finally, multiple that Italian we've survival registry analysis called more the being again benefit confirmation seen same early even exact consistency. across benefit has before to presented this shown in the types, benefit, by replicated this know databases, patient group Scientifically, across we EASL the completely care systems June patient was Recapitulate, patients. the health able replicate these is critical to of independent which that a

their that therapy. outcomes. has the indicated able now over only the compound additional we it that follow-up, has We advocacy since benefit follow-up, basis demonstrate and outcomes, over these been that, only now modeled real advocacy and -- has evolution. clinicians and that XXXX, well line placebo heard is showing to patients individual we've patient And data, And because progression as long-term the been the XXXX from again would not societies basis, on on for line third, have is they're datasets. and unwilling to standard second for know multiple as long-term for that the care that across different therapy the physician of Ocaliva both to second Second that of as put

standard term of to patients evolved, the looking are have we longer realistically studies to what we be as for do about these asking So outcomes. has care to get to

Brian Abrahams

Thanks the really much That's helpful. all so for detail.

Jerry Durso

Thank you, Brian.

Operator

Please question. standby our you. next Thank for

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

Your line is open.

Jay Olson

on Oh, seen thank setting? for Would pivotal hey, replace plus line from for perspective, it's trial in on Beza line the UDCA more combination. And early possible quarter think the a data you Based taking the philosophical you you in the consider first and a OCA to that you've efficacy treatment PBC? running questions. first congrats do maybe the of

Jerry Durso

maybe you Michelle, start there?

Michelle Berrey

Yes.

forward driven to We by we so -- have agency. course, be the really those certainly we with survival clearly, hold encouraged great have the just on to which, a at will off analysis, look with line data, one So our getting fixed improve get until outcomes. really planned it's question. are quickly the we datasets. And or to of first get therapies decisions will dose important that by it continued discussed of know not but discussions The combination, second the for full patients look those emergence is data on we're all that really interim and we

point, think have us is I informs at data though, our of setting -- combination. seen that what the survival we that is the this in

were folks Ocaliva, So to so or Ocaliva, more as they with to as getting moving to fixed on patients even who key I when been intolerant, And can so I has we're urgency, that's the think dose benefit the think their message. disease whether carry possible. in in full for forward reap patients combination a quickly that'll addition early in

Jay Olson

you. Thank

Jerry Durso

Jay. you, Thank

Operator

our for Please Thank question. next you. standby

with next line comes from Our Jefferies. Michael question the of Yee

is line open. Your

Unidentified Analyst

[Jenna] for the could versus regard combo to coming you. OCA Thanks specifically, on of about the combo taking potentially PBC, new as should to morning. others. profile for the (ph) the on And This think good shows With Thank Hi, our your how questions. a potential Mike. we priority product is pruritus?

Jerry Durso

Michelle, want that? say you to

Michelle Berrey

sir. Yes,

seen. multiple looking seen there But I out improvements is we've again, by and into which tolerability we as data, combination, fall. are achieve, the the approvals encouraged safety. we've It to and certainly data have and watching in the are in think do with that are And improvements have that we implications something efficacy, those We early also biochemistries. for ways coming the across certainly we'll initial space, are fixed-dose that discussed, on improvements

which those appropriate. we saw way encouraging very So initial, to allow study, out at us the to rates we comparisons June are collect in those reported do for looking as data are will pruritus, continuing a as that as, in XXX much we

are is short-term staying think by those patients answer we're on very therapy, I encouraged the data. and

So we the to in forward fall. look more sharing

Operator

Please next you. our Thank question. for standby

from Our of the line with comes next JMP. Wolleben Jon question

Your open. line is

Jon Wolleben

the Hey, taking questions. on for and congrats the thanks progress

Just hoping XXXX? consider what meaningful in Thanks. you you profitability could characterize

Jerry Durso

Yes, question. the John. Thanks for

we all things the of we in $XXX framed, are savings that target the we're be steady can And as call. sketch on plan indicated, we we're at terms once we'll had progress in savings plan. We As referenced Andrew, last bit out more how next period year a a thinking this towards finish. execution little the million you maybe progressing. things through state of savings of where as well track,

Andrew Saik

Jon. question, sure. and for the Thanks, Yes, Jerry, thanks

growth, anticipate in haven't intend with into given we year the to don't said growing we four course. having of year. yes, guidance end you and consecutive give until to year, So, Jon, obviously, normal we quarters Ocaliva know, next the as guidance look of we yet, next our But that,

of but on to we grow. giving to range expect $X.XX. $X.XX guidance We have we're Obviously, year, continue to next guidance current not

a what pretty spend our we That current of number meaningful want to $XXX very to that regard next be into X next headed good feel like year, expenses, give dose, We study expect should indicated $X.XX a we for like in savings estimate where next to Phase With So good includes $X.XX we right? things off you year we think our and year. to fixed some million achievable year. visibility we we're are. generate given EBITDA, it's

Jon Wolleben

Thanks color. Helpful guys.

Jerry Durso

Thanks, Jon.

Operator

next Please you. standby Thanks our for question.

Partners. the line Thomas from of comes question next Our Leerink with Smith

Your line is open.

Thomas Smith

morning. for Good guys. Thanks our questions. Hey, taking

in I price don't launch Ocaliva price think think, pricing, I like August here calendar there's two list X.X% is took since Ocaliva looks year. you've a Xst, been taken on it price Just year the increase second a increases which same year. this where increase, you on

you can think strategy talk your about how and we So what about, forward? that prompted pricing just going should

Jerry Durso

Obviously, for basis Obviously, that and thanks on pricing Yes, the our an accordingly. prices strategy. set we're we on Thomas, ongoing question. value offers comment detail Ocaliva don't the looking in

capture the point. You this probably did not comment took action and on from that at we me that more

Thomas Smith

available guess comment I patients. to some X.X I things the about potential obviously enrollment but just XX the -- has then could thinking impacted commercially it a driving one I how like may X that and about then talk multiple And, enrollment took, enroll about combo, in products. there that study also Ocaliva, world OCA-Beza if have you're it seems you on years just program, Phase on the of into competitor sneak in Can a think, Europe Okay. potentially

Michelle Berrey

year. last the that Yes. over pickup folks of is and pickup recognizing you that had about Phase where And X, countries to this for Happy patients performance, efficiency, discussions, dramatic specifically, have imagine, to already might disease their did a enrollment that European address the the completed need planned a to at at we in have as interim are. the is of at maximize saw our optimize will slowdown enrollment I How analysis after for enrollment, lots say rare a Yes, we go EASL, can site looking and enrollment. X the looking XXX how the second had had we've what in various signing that the up presentation we Phase our that we've on in then pandemic, one.

seen you get more thing when that a enrollment than finally shift, quote always areas, is characterized a that, probably a best are disease in excitement can [Indiscernible] shift substantial one realizing XX% therapeutic about consistent X half mark driving he's I Phase area very patients you though, by of in where that benefits who to see in really start progression. their therapeutic and excited real and cross is think across we've

that we're really getting of running. a lot interest, the driven has program and and think about up excited I the

Thomas Smith

makes sense. Thanks guys. That Got it.

Michelle Berrey

Thank you.

Jerry Durso

Thanks, Thomas.

Operator

standby question. for Please next our you. Thank

comes UBS. question line of Merle next the Our Eliana from with

line open. Your is

Eliana Merle

so taking the Hey, question. guys. Thanks for much

size, the And that XX duration trends see persistency your have on OCA. some at of the seeing, six patients in you of in terms Just you're have, of and I rate being you, average commercial months. what's

period any of color curious time? a you longer over can Just if provide

question. as experiencing second a just of the just are any of on then underlying comment patients OCA still part you info Can Thanks. even portion what And at and pruritus, disease PBC the on severity?

Linda Richardson

persistency, start So with I'll okay. just that's if

XX% patients very greater two the have across what than think see at drug XX% with the of we -- years, comparable. we at on I which is persistency board our is that

prevention, superior MS, statins. of looking fact, In stroke average X classes the the of Type lot to diabetes and at

have So we're we as kind normal, patient many that on just do chronic would to a what conditions. of, And close dynamic us. for going you dynamic quite across see

that by as that country to impacted see factors ex-U.S. I countries. think, some the other are of in, a compared We you

So there's dynamic just general. in that

who you also about is of pruritus, pruritus report talk that have when XX% Now patients, PBC pruritus. about remember

have condition. see you mild vast is we the dynamic trials in half of that someone's the And with then XX% managed. world, see techniques When was you be get to having Ocaliva know, of at that pruritus. that. a, moderate So pruritus time, seen part it the that as a we It's can when of of any if you it's and in majority the real management and period you to implement about can

You can cut the down on dosing.

how intolerable The have really go label is. reason, articulated on the depends product. itself, off pruritus would bothersome There knowing it weeks. any it various for for on strategies are who aren't people how in You imagine, can management the two have many, I

something to wouldn't was on continuing be was on they limiting, for that drug imagine speak I years. stay have people So issue. can't the to who if how really many are two it that rate would I

Eliana Merle

so color. Thanks it. the much for Got

Michelle Berrey

welcome. You’re

Jerry Durso

Thanks, Eli.

Operator

question. next our for standby Please

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

open. is line Your

Unidentified Analyst

Hey guys, for Brian. a the question good combination. pivotal on had study bezafibrate [Charlie] about for We (ph) morning. potential This the is

arms also already then arm patients and at do Thanks. patient inadequate each one patients, Specifically, you starting you kind OCA enrollment how about OCA, would the on placebo? looking are one OCA getting have when naive of as comparator arms of would Or population? those thinking responses you're your criteria? getting, with Just bezafibrate? you then And

Jerry Durso

Michelle? Charlie. Thanks,

Michelle Berrey

of have anticipate, we contributions for good do fixed sufficient that fulfill to dose in order all requirements combination each data Yes, showing a morning. the agent. Hi, independent that you the

Now we'll from to whether from something your Phase Phase come that discussing has studies or or be sources not with other the X or the agency. X from is

of at bezafibrate but we arms monotherapy, monotherapy, we may the as I arm one think two is in. of probably that assumption in go going our monotherapy, have least

the on for study, placebo placebo in standard double know, patients certainly you The or blind ortho, plus it’s again, care over XX-months the placebo where to of big that's patients, than seven years, ask stay topic to difficult a portion. last placebo that's the PBC whether changing with more again,

So would one at monotherapy stay tuned arm. expect on that, least but, I yes,

Unidentified Analyst

Thank Great. you.

Jerry Durso

Thank you, Charlie.

Operator

Thank you. Please our question. standby for next

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

Your line is open.

Ryan Deschner

This Good is Steve for Ryan morning. Seedhouse. Deschner on

IBAT sort And ask to potential on a also timeline as see the then wanted data Just from target updated REGENERATE? in specifically the portion on you that of outcomes Thanks. get to expect guidance to any impact how thoughts your of current you're if such have wanted pruritus you what inhibitors? mechanism could space, seeing PBC

Jerry Durso

the in one take a maybe but working take background. we're I can and on early where on little IBAT, So the it's think obviously, the second then Linda one I'll yet, the first that

with available announcement to time on and will appropriately communicate discontinue work we So in said REGENERATE data the our that. as at capture the right the

of focus important of activities. the on the again, of all the is closeout work team the So

next and of we end There closeout the do beginning will year. sites be said, the part data. of that As appropriately will be things closed a But we little the capture year. to costs into bit material final flow that this anticipate the might is the some part of

Of sites the the as based And with clear as course, appropriately working that good all would to we on data, the make Linda? capture closeout. we sure that we're back is communicate practices.

Linda Richardson

patients part they've of I'm the to as programs incidence with if is X or a think they aware IBAT it I'm -- disease-modifying the of the life moderate or in is that that PBC, opportunities. to all in think But having that at addressing not their story marketplace, by interesting were any that may that the details shown quality pruritus an expert means of you're on do disease state that that address can And in -- if the future. of an I in point, something element. bear the IBATs I not symptom an important come help have this

look other be something something and markers. ALP at you to bilirubin would the disease, AST, it may really still to So address lowering but need ALT,

imagine at So for of symptom disease pave itself. a progression still way while to the need of look the of it I there's lack could of right stopping therapy kind PBC, improve now, the that to

part PBC. potentially that an point, ongoing beneficial Ocaliva So on address experience at part that became this of I be of that think could patients' to to strategy

Ryan Deschner

you very Got much. it. Thank

Operator

for Thank question. next our you. Please standby

question of line the next Baral comes Cowen. with Our Ritu from

Your line is open.

Ritu Baral

control for least round combination, to will guys. just going of back you Thanks Michelle, the the what something in wanted serve prior questions as at the in. it question. the arm taking will Phase as I morning, about some X Good for on mentioned you propose

a You arm. mentioned monotherapy there would be

a that to this the least [Indiscernible] left the serve I analysis be with of that statistical you placebo sorry, one of think would you the point shorter-term endpoint? possibility approval was would think there I'm open primary at full have guess, it full -- control at accelerating? which do as And arm, if placebo, I change could approval for Ocaliva

Michelle Berrey

Right, right, right.

as only comparator. you're bring serve you yes, cannot accelerated a approval, it point that up under the while still So, do good

claims post-marketing with shift a we approval of get your have And really and to one the have of external continued PBC, multiple have we where interesting but patient to patient requirement, of the continue established that disease. the out of now does fulfilment in compare You care. standard these of registry though to history to is our and to databases, full as questions natural we controls Should utility back the build placebo. the registries

for basis We a even data great the incorporate external we've to pull powering study some some to to be within have the as controls, which either able those the presentations and study. how on of seen or data,

patients, be for portion this would hopefully, for decompensation short to on through think I to who be space. the that the have death. hopefully And patients evolving or liver could again, placebo to and decreased to on go placebo Phase So double-blind X, is when that of transplant or just that require an not proportion

in think the a on those field happy expectation creative being we're shifting to supporting I that's one be designs. and that

Ritu Baral

mentioned I'm use. Linda, commercialization Got you real data bit bilirubin sort in it. of competitive the support or bilirubin have commercialization? hand you world quick Can Ocaliva a sorry, something follow-up, about continued elaborate for -- for data what And to benefit very little in having you'll a on

Linda Richardson

at both XX-weeks and a we very data that and knowing of disease. can look you from have where element is XX-weeks Well, bilirubin progression of important

see move, not extension, to also you And open-label that's we bilirubin were start a that if without even our but good to for progression. able that maintain we in So showed fibrosis, not patient. only

important very So physicians. to these that are are things

Bili? else anything that Michelle, think on you can of

Michelle Berrey

really part patients not -- it's about who see so part bigger in who the at the it's a progressed not contributions is kind of on already all started burnout that appreciation their are enough, so the who've elements, are overall a and and more, were who story other early to some think to biochemistries looking other that in I of the in it important in Yes, just bilirubin, particular, their story in starting of this ALP it at is biochemistry. perhaps of look elevation ALP, total

the know bilirubin the X that extension We registries. are these elements. across tell now open looking X, story. have those X, and data label both whole large patient We doesn't at that really from years ALP also critical GGT

Ocaliva. additional So that outcomes forward we with that for data and improved the front how correlates on that sharing to demonstrated we've look

Ritu Baral

Great, thanks.

Operator

next our for standby Please question. you. Thank

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

Your line is open.

Matthew Dellatorre

This for is thanks. on Hi, Matt Salveen.

the could give you how more far IP? OCA between remind and you. SG&A breakdown combo And $XXX R&D? the on guidance, us would any Thank the beza details expense On extend million could you just plus then

Jerome Durso

Yes.

and X Andrew can the then maybe first IP take I'll So handle. on

potential great see we're One the OCA-bezafibrate a for opportunity best-in-class it's been to starting and is the read us. real for twofold opportunity, always the that points that therapeutic look, to has out So here. data to the

management. on Second yes was cycle life

a reminder, it's or entity as U.S. as filed been a market chemical is approved new here. in never So the bezafibrate

covers We in a doses would which IP XX for the issued anticipate additional extension have combination, range of PBC. probability the term broad on first patents and patent roughly We both beyond.

long-term So again, as incremental a us. if that about opportunity think for real we

Andrew, take the question last maybe you on OpEx.

Andrew Saik

sure. Yes,

regard NASH combination way year. R&D extrapolate about would that out, this of the I for next would one-third line expense. on with about think our the it, So SG&A to To of OpEx been the throughout it's R&D year, rest $XX million has reductions it spend of always in our about The a spend be line. NASH reductions the

Matthew Dellatorre

it. you. Thank Got

Jerry Durso

Thank (ph). you, [Salveen]

Operator

That Thank no participation. Ladies call. and for showing concludes conference I'm the further in Thank today's your queue. gentlemen, questions you you.

You may disconnect. now

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