Intercept Pharmaceuticals (ICPT) 1 Nov 172017 Q3 Earnings call transcript

Company Profile

Participants

Mark Vignola	Intercept Pharmaceuticals, Inc.
Mark E. Pruzanski, M.D.	Intercept Pharmaceuticals, Inc.
Richard Kim	Intercept Pharmaceuticals, Inc.
Lisa Bright	Intercept Pharmaceuticals, Inc.
Sandip Kapadia	Intercept Pharmaceuticals, Inc.
Rachel L. McMinn, Ph.D.	Intercept Pharmaceuticals, Inc.
Michael J. Yee	Jefferies LLC
Brian Abrahams	RBC Capital Markets LLC
Alethia Young	Credit Suisse Securities (NYSE:USA) LLC
Ritu Baral	Cowen & Co. LLC
Aspen Mori	Bank of America Merrill Lynch
Jay Olson	Oppenheimer & Co., Inc.
Andrew Scott Berens	Morgan Stanley & Co. LLC
Alan Carr	Needham & Co. LLC
Dae Gon Ha	Leerink Partners LLC
Joel L. Beatty	Citigroup Global Markets, Inc.
Liisa A. Bayko	JMP Securities LLC
Brian P. Skorney	Robert W. Baird & Co., Inc.

Call transcript

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Operator

Thank you for joining the Intercept Pharmaceuticals' 2017 Third Quarter Financial Results Conference Call. All participants are now in listen-only mode.

Following opening remarks, Intercept management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request, and a webcast of this call will be archived on the company's website for two weeks from today's date. I would now like to introduce Dr. of Director Intercept's Vignola, Investor Relations. Mark ahead. go Please

Mark Vignola

business us Good This call. our at quarter providing www.interceptpharma.com. joining our available press morning thank you third a and results and on financial which morning website covering is on today's release for update, we a issued

of we development be estimates the as and lines pursuing; including Before to which clinical beliefs forecasts These statements relating our management will regulatory other regarding please for based operating statements time expectations and as forward-looking programs plans, our indications remember today, relate begin certain as or estimates, are our on financial and of are and performance; events. future the acid, statements and for anticipated goals, today. our we we future Ocaliva; to discussion making obeticholic statements today's call, commercial on well and market

on our risks primary obligation recent reports our any as should the in regulatory with or is authority in actual on materially information, filings by Investors to will OCA Mark Exchange time. in Richard are Commission, Financial most Kim; to the section from read cholangitis, concerning drawn would this results Risk slides or Commercial, take assume of forward-looking indication to statements, our by and note Kapadia. XX-K product Lisa open your begin Form PBC. and in report expectations. update Officer, other described President there biliary U.S. including Bright; our our Factors We'll the those accessed that call from from of like of Pruzanski, of that carefully than those Senior call filed whether IR can followed with via Events Securities today's or International, and at investigational an indications uncertainties Sandip CEO, the We our Vice remarks that then and events, We our Head be differ may webcast or section of questions. annual SEC. U.S. closing our efficacy our webpage. Our be in Chief with approved The been a the and associated use can and for no by new of with the OCA result call conclusion revise President No future otherwise. has other the not safety any

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

Mark E. Pruzanski, M.D.

not on medicines have Intercept patients liver quarter in to thank by witnessed and Good of past for and progressive breakthrough or Ocaliva start Mark. third acts sales joining storms been us non-viral Today diseases. employees and patients our In call. these with you of harmed. resolutely developing we devastating morning serve world acknowledging our terror physicians the and the that events, the primary biliary grateful I'd around focused PBC. knowing few Thanks, and on marketed reported we've indication, I'm the remains cholangitis, months, like face we for today's the million in over $XX.X

Ocaliva response recently important patients profile care. for the option and the we're of treatment represent continues raised addressing post-marketing currently PBC concerns, that an the an benefit/risk of or we're to remains While of safety with many confident it standard intolerant inadequate and unchanged, favorable to

week, we about field. the leading of position the coming feel front, OCA our increasingly AASLD confident and potential NASH Liver the off On the last Meeting in

to pivotal REGENERATE X to approval. Phase support in the flagship regulatory report NASH track data on Our is trial first

and with we provide Lisa for will view in later and optimistic showed thought physicians been PBC to market support continue treating finalized an detailed label business, for and the we updates by have on the robust. Now specific and some to active with provide a the in first leaders Ocaliva. Meanwhile, latest Ocaliva quarter continued call. feedback positive for more are progress discussions our label and early to in Demand product opportunity Ocaliva the continue long-term Richard on we've regarding PBC. growth, as third will U.S. XXXX. in international our and performance launch FDA update a update and the us

clinical As well of results exposure We and process adjudicated X,XXX reviewed safety FDA. epidemiologic including safety patient as this with part by independent disease years shared study now of adjudication all we have additional our post-marketing the of been which process, data over of progression, as the experts. reassured analyses by of and have our documentation PBC of data feel

further today profile While benefit/risk patients believe and to the label, any provides it the we need. product the to we in update to cannot in value Ocaliva's of provide details resolution pending continue

of the our in of May enrollment reiterating now to Phase of as XXXX. we NASH completed the announced analysis cohort the this of data Moving interim the REGENERATE interim for first guidance we program, in analysis of trial, and are year, our half we X

a with respect we DASH for design X With Assuming OCA cirrhosis shortly. trial remain track before on to result, to will year-end serve details share on the patients fibrosis. use to this planned to as our positive basis of trial, and the plan the initiate trial Phase it expanding NASH

to medical the Phase in PSC excitement were at the we the AESOP Finally, and primary the trial pleased late-breaker We the have featured AESOP presented as X OCA results about results. meeting. from sclerosing at EASL week, thrilled from a see cholangitis meeting been the community recognized with just or of last

and appropriate array of no liver on diseases With be for non-viral engaging OCA these data, we'll second the of PSC, a potential FDA in approved determined XXXX, steps. in a concept disease have with have clear we back next potential we'll high proof and OCA with underscores broader need. we progressive of established cholestatic the treatment, liver unmet Based further with this when in report a in

path The what As remarks is with available in conclude OCA's saying determine in efficacy profile confident we PBC potential. In by safety very and and time. that expect I'm my some regulatory take to NASH PSC short, of the the before to several to breakthrough I the challenges will it, OCA base our and process liver to non-viral we face the these Intercept diseases the in in as the by continuing therapies bringing diseases. dedicated from liver supported most progressive meet to patients to mission leader suffering remains evidence robust team field. is

are where to global Ocaliva program NASH sales deliver tremendous continue We clinical need. growth and in PBC for Phase for our unmet X leading there's advancing

building to a Richard for it biliary including the also other in over for high unmet I'll diseases and Ocaliva are turn We With update. U.S. that, PSC with needs pipeline atresia. commercial

Richard Kim

Good morning.

XXXX. net the million, $XX.X We $XX.X and quarter our sales achieved the with compares of Sandip of in includes one-time keep will this million third $X.X second quarter. Also, in of in please a U.S. mind revenue in Ocaliva pleased million benefit discuss. we're in mentioned, recognition $X.X Mark the change quarter a third As that which following that deferred to year in performance this quarter million revenue

growth quarter. The over showed second the third quarter demand steady

As during anticipated, business small due the months, saw demand patient Irma. summer Harvey a we and impact to and slightly softened new Hurricanes to our

on experienced the the letter additional the in we safety Provider Ocaliva. Towards communication Health prescriptions Dear also quarter, softness third and Care the following FDA end of some

have to and patient the to pharmacies New in patient September grown and Interconnect, enrollments program, compared this referrals into specialty October our support summer.

safety website you just recent the at they refills of the see last this Ocaliva until a by driven are the to supplemental over patients their drop morning, existing end on the can delaying on posted However, believe couple on weeks, the shows that trend. has the We TRx after prescriptions which September, the slides see physician. opportunity communication have dropped. some data, IMS But upward more mostly is of an

Our use it weeks care priority impairment physicians of appropriate priority. The reinforcing on these safety to physicians the reeducate towards We providers Ocaliva manage the in to rebounding and that health patients that need making and appropriate a recent with prior while helps remind of rates to is the to PBC. high refill always most the caution hepatic safe believe unmet by other data show it communication. levels our dosing

well our medical speakers our dosing for target Our physicians patients. teams as adjusted sales reeducating proactively the all recommendation have impaired hepatically PBC been of as and on

made communication. with that ensure thousands they teams, patients, The have our Our across with Ocaliva. had maintain to all research advocacy face of enhancements we the to of to latest and this prescribing that the pulse initial target to Interconnect physicians for improve patients our patient of vigilance level research following We teams to PBC either advanced conducted have and amongst communication shows medical consistent face patients, safety Through our increase insights. groups to will reaction or their for get XX% PBC all an interactions physicians also made PBC. including more advocacy have and our further patient liver communication

of Specifically, increase XX% prescribing that for maintain will either patients with hepatic physicians Ocaliva. say of impairment, or they their

a point, any the For remains Ocaliva PBC from payer impact we in seen good efforts. about patients evolving, response feel patients, this patients hepatic not changes treatment we good our of use fundamental initial these perspective, up as and feedback, as Things impairment to X% the have a about communication a customer but prior X% criteria. this the in overall make that authorization And up to reminder, lower belief for a strong. for to population. PBC are as still From see we this

the focused past the appropriate have on can intensely and couple communications around see, for safety communication. we you As months, of actions the been

and us, Our or need patients thousands physicians from growth the And non-viral who now for meets never time, of remain a treatment PBC target UDCA. more to conversations liver Lisa. commitment your in inadequate new our evident unmet intolerant their of feedback in for for to long-term of disease may the I'd right reinforces over Thanks response been The call we and patients than how like PBC option. has Ocaliva and focused an on the turn need opportunity with now. belief to be

Lisa Bright

to we've Thanks, morning, everyone. tremendous Good U.S. accelerating pleased in XXXX, Throughout access progress the Ocaliva at been patients for outside the Richard.

$X.X For quarter, Ocaliva the sales third were international million.

by sales expected, we and driven As be Germany continue to had France. predominantly

well countries there access by major middle have ahead approval, of completed sort Ocaliva. of where these should a reimbursement of some demand pricing countries EU of of and exception and Finalization year. year outstanding in the be norms. for ongoing, interest in now positive and national remains and Canada regulatory of patients With for all Spain negotiations high within remain we obtained next industry Overall,

recent increase done XX% most more prescribed over have the XX% in PBC number that the of say for intend suggests least they and once, target at of to months. physicians Ocaliva physicians in our research in six Germany, next example, prescriptions than those Our September of

end we over call So the head positive turn to like year. of as to I'd into the that, the we're Sandip. With

Sandip Kapadia

of guidance summary net sales position, for the And results our press sell-through is We I'd financial Inclusive well The a Ocaliva the was quarter third Lisa. recognized third XX, XXXX. you, issued Thank Please $X.X Prior an revenues take quarter our a sales September effect deferred we to to good related change $XX.X in net quarter today to refer increase to earlier worldwide XXXX. XXXX, July million as for net QX the to results, using you in million as revenue. XXXX. the of worldwide everyone. like provide of a estimate year. of method. of revenues the one-time this recognized for morning, in overview for net balance the cash the opportunity release give for the ended

sell-through method the experience to occurred enable quarter from third product sell-in XXXX, commercial us sufficient transitioned the of reasonably to the our of During returns. has method recognition as to estimate we period revenue

For related the estimates in deferred $X.X were for revenue. to sales $XX.X which million includes the net U.S. change quarter, million,

million, QX revenues. includes For the quarter ex-U.S. the to constant change related relative deferred $X.X to for remained in million were in which QX. $X.X estimates net sales Gross-to-net

programs. for by operating clinical were the OCA Our and relative program non-GAAP adjusted $XXX.X these initiatives for in to increase support XXXX international for primarily is our non-GAAP support driven commercial were to expenses million million infrastructure the and personnel quarter. operating costs GAAP and QX and operating to The expense development expenses quarter $XX.X related

We during during sheet. cash, the quarter ended the quarter. a our offering. balance our notes $X.X of million cash of interest expense We outstanding convertible cash million quarter also approximately recognized $XXX.X reduction million $XX.X equivalents from with securities the represents This investable and of third of on

turn for me guidance the of year. to Finally, the balance let our

growth the recorded specific sales of for are like be we Ocaliva, sequential reiterate $X.X to of providing revenue quarter-over-quarter our we not This would million guidance would in expectation While year-end. QX. for one-time steady through net net

operating $XXX XX% lower expect the one-time the We of non-GAAP quarter. of our to This XX% be middle gross-to-net expenses of expense fall the guided project X includes in of in to adjusted the our to towards Phase the previously trial guidance start-up the for the for range. million will to year cirrhosis fourth the We end related several million. range year $XXX

expense year, operations resources an the the effort expect full notes. and of convertible by which focus expense our our outstanding of advancement our includes also of we For for the approximately million, commercialization re-prioritizing our development We're and OCA interest amortization embarking and our reduce NASH. from Ocaliva on to $XX to streamlining operating on the ongoing programs component clinical growth

effort, that XXX our for part development we have the As de-prioritize foreseeable to decided of program future.

operating our as represent financial anticipate the reminder, is significant a a measure. is expense in expense will that adjusted adjusted our to most operating Please expense the item non-GAAP now to non-GAAP compared adjusted for Mark. press compensation as Finally, expense to like noncash a We stock-based excluded to operating historical expense. to refer expense call I'd turn operating reconciliation GAAP of under release over GAAP. operating

Mark E. Pruzanski, M.D.

Thanks, Sandip.

appreciate the to Officer. up important she is XX year, play her tenure. significant an to Chief during the open be in period. the therapeutic we at approximately to the to end strategic Between company contributions transition she end leaving as we passionate call to about. Strategy accelerate Intercept at McMinn that year a continue which company will advisor exciting Rachel of of small pursue from the is her down and of commercial now for Effective Before I to helped opportunity deeply through Rachel your greatly as company Rachel's Intercept, a step fully the global entrepreneurial announcing committed transition from our a this will role supporting the area and Business will an role biopharma that and a company today, questions, are today people

success and operator. had chapter critical her career. next to With leadership fortunate of turn her in all over during in company's cycle the are wish things have her the the a We to time life I'll that, the

Operator

you. Thank

question is Yee first Michael Our from of Jefferies.

line Your open. is

Michael J. Yee

Thanks if but how label biopsy the would studies? Hey, or would as characterize as a suggesting question. progress those studies XXXX that of made mild your would Mark first – are commentary or by much. for it versus patients away you'll guys imaging as as be just perhaps what and types Maybe we discussions context to Thanks any, relates just expectation you or on early maybe to it question good then for Child-Pugh there, such second came and a regulatory is data, – change looking know a of studies data? for there don't, as And at morning. some be is endpoints, the all you've had there, obviously what, her B And change given that Mark, If of so You've biomarker AASLD from focus that far more if how C severe to as concern appreciate into patients? comment endpoints she's work. on at in that that PDFF. label question so that? aware, interpret with lot relates our Rachel's some I Maybe we should you a the as I'm don't look of don't put maybe, data, have

Mark E. Pruzanski, M.D.

Mike. Thanks,

the So so lead I'll is answer her here, the on first I'll question second. and let Rachel take the

that to safety That has all to to as XX on referenced process the select and did remarks, September analyses said data dialogue if update, gone and clinical year-end, to and label, external findings we has negotiation, the final and our want a adjudication get trial we that find completed XXXX. additional my in our has the respect just follow any in cases about experts process. our epidemiologic event with communication we review by actually away constructive a not we I come FDA in of up commitment on population. FDA So adjudicate I of That by I our in prepared I rates in very is database. and others in identified been now reassured reiterate label iterated early is FDA with PD which into then could background the the mentioned, label this said, what to We're as its that of analyses on call as hope

the label in advanced Now and and with the is patients identifying need that looking most B patients further dosed question after goal I risk to of these to said risk, the before, at I've here C can your patients in who aid different on of also subpopulations reiterate, Child-Pugh average patients cirrhosis most the with of is and manner are fragile respect different patients, who primarily to what at update main a decompensation. be clinician

Rachel L. McMinn, Ph.D.

for Hey, question. the Michael. Thanks

terms In we is more did AASLD endpoints, couple in our other a and One competitive of walk say position. confident overall I'd away of things.

you the conference either at feel stage there, that that OCA do remains the not the particularly a conference leadership was was surrounding products or position. the at for data that or some in If look of later we solid was

Specifically keep though, hepatic outcomes. very good not fat is or biomarker way, Unfortunately, have fibrosis in shape, mention, mind improvements been surrogate any correlated around changes for in you or the longer-term in form fat, that hepatic with fat. PDFF, a

final relying regulatory we So risk. fraught for be of clinical the biopsy are proof studies. thing looking concept I forward would is in is data specifically I agencies, of PDFF so significant on just, then the move that hearing as with to And say could FDA, proof particularly principle guess

it's unclear. So

how by program authorities and unclear Phase it's data using the overall short into that studies interpreted of example. these for proceeding in biomarkers, be development Some X, regulatory that relatively are clinical duration novel will

Michael J. Yee

that. interesting. I guys. very appreciate Thanks much, so That's

Mark E. Pruzanski, M.D.

Thanks, Mike.

Operator

Thank you.

of Brian from Abrahams is question Capital next Markets. RBC Our

Your line is open.

Brian Abrahams

for your Congrats my Thanks guys. continued the on on and Hey, luck of the in to accomplishments Rachel there progress, taking future. all questions. best and congrats

Mark. maybe Richard. seeing Just a for are you in the away physician change curious some you most Ocaliva if more any or use whether Can tendencies, describe refill education? types and patterns milder then of beyond where maybe titration away non-decompensated detail shifts that question patients, been daily in regions delays? from First opportunity for had there for or see And a follow-up you're little in the bit the U.S. any in patient dosing the there's for settings – towards the I any

Richard Kim

Yeah. for question. thanks Hey, Brian. Hey, the

the patterns as what constant able think and steady country. to maybe I proportions would way I an softness the So see to we regional prior But a seen little no titration a again. see as Provider uptick on far to general say Dear is, the we've sort did been – per would Health services. differences We've in and summer the the the have our is sort across of milligrams Care from we're statements of daily The bit the over stayed in while. twice-daily safety to to see I concerned, XX see communication, milligrams, are bit relatively it actually in the of describe there's X a real that we and dosings always pretty as starting of change the letter last

maybe fast difficult judgments doses hard, with it's any a to are think make little on those numbers that. the small of patients I who on So

would seen pattern are to to what next maybe refill I continue the the dramatic it's of think here, mentioned for as earlier. say shifts some while going we I patterns minus as far the haven't that little but concerned, I evolve really So

Brian Abrahams

promising been Is maybe really could financial if life to extension That's anything, was without XXX FXR your a activity expand on And cycle pruritus bit despite strategic versus Mark, as helpful. early preclinical wondering potential data. contribution deprioritization strategy? the change association? a efficiency? could perhaps on TGRX just serve an it. there XXX of this development could thesis for Has I earlier-stage but very TGRX that as any is And as prioritization potent little Got that there be Thanks. on some then, you maybe

Mark E. Pruzanski, M.D.

diseases. you and other its alluded remarks, our in Look, are of prepared prioritize position to continue looking believe and Brian. in market in OpEx Thanks, to mentioned maximizing OCA NASH asset, we in non-viral the progressive leading and to and we in but liver Yeah. streamline the as we value

have We options named promise, exploring we other code you one in XXX FXR There that is will at and highly which a is be pipeline. stage. advanced is into preclinical XXXX. is a XXX a heading the our for of shows being that compounds agonist albeit Since asked, do and lot selective

Brian Abrahams

very much. Thanks

Operator

Thank you.

from is question Suisse. Alethia of next Credit Young Our

maybe Credit relates for can from have Thanks as is your to Young NASH Your Securities cirrhotic trial? one underpins of Suisse around two. Europe? I wish something you cirrhotic discuss communication any for States LLC guess my also, the is - the And Alethia United you NASH Hey, of the the it taking Rachel, just luck. seen the your what there impact And cirrhosis Like (USA) Lisa, line between question. different open. liver? confidence you versus Maybe guys. then I PBC particularly doctor liver best in kind

Lisa Bright

Hi, Alethia. Thanks the for question.

mean, from efforts we've as calm really, appropriate has the as I patients. continuing per impaired ongoing pragmatic. response label pretty dosing physicians been been around educational said, I the for Richard do hepatic and So to mean, And

nature some disease patients that progression. lot a recognize they this experience of serious think they the I of disease, recognize and rapid these

haven't started. my And generally yet patients think solid of in sales very we predominantly I physicians as that those Ocaliva of to pretty say pragmatic. strong hepatic about, what And even we've the main intent are try The countries. talked are patients starting amongst So impaired said that the pre-prepared I'd calm, remarks, group generally, in launch pretty pretty to kind not as prescribe is our on. are anyway that is all of

summary of we're think where at. a I yeah, that's So fair

Mark E. Pruzanski, M.D.

to mentioned. the Alethia, cirrhosis We're study prior NASH to I confident the are we proceeding as with year-end. in on track program, initiate respect to

with be We shortly will on details coming trial design. back

the don't Suisse might Young curious in difference cirrhosis their mean, occur Alethia kind be any hepatic (USA) - to disease. cirrhosis is between there the will there, more patients NASH in if PBC where obviously, cirrhotic a just a notable impairment like into mean Securities there's I Credit know of part compensated question, yes, going like need. and unmet And patient your advanced LLC the another significant is I asked, patients? I though. is we cirrhotics obviously in Well, the there that You

Mark E. Pruzanski, M.D.

as exposure Well advanced Okay, many No in needs of bile a I patient. versus are any liver and We all, said and in surprise, and NASH a a different mean, Suisse LLC NASH that we'd great. dose-modified fibrotic Thanks. PBC exposure – most patients, it's very of like effective advanced NASH. drug the non-cholestatic you between different NASH. it look, to first and different NASH hepatic predict drugs PBC of (USA) - you get cirrhotic our very obviously have that Young be expect diseases story. wouldn't compensated meaningful like modified in disease patients, acid as decompensated cholestatic difference like disease Alethia kind are Securities Credit But a the to in a same a

Operator

Thank you.

with from question Capital Markets. Ian next is Our BMO Somaiya

open. Your line is

Unknown Speaker

point patient This Thanks get And your Hi. guess, I that's on competing persistency to? impact how with you and physicians' and thoughts (XX:XX) Ocaliva. thoughts and I wanted for decision on prescribe on elevation differentiation, to pruritus Yeah. LDL is taking for could also playing into Steve to the agonists question. that FXR Ian. on

Mark E. Pruzanski, M.D.

Sure.

a in the But hand LDL. pruritus Ocaliva on increase that correction PBC to does I'll not question. So just Richard I'll patients, add quick

Richard Kim

Yes. Sure, Steve (XX:XX).

part a initiating as we support patient far care any services concerned, well. decision launch, with of significant health around as As so risk/benefit also and very really have seen providers physician and patients really this it's great of and the been is barrier this of to to pruritus help day the a proactive We've really obviously, patient patients, it haven't communicating we lot through. go that as along since

see there's seeing is concerned, UDCA. with what we see saw sort as what have if delays these So still had our with to as impact close we'll Obviously, seen from we're alignment adherence of but some still traditionally UDCA. we far in we to to aligning refills, generally persistency generally, very of

Mark E. Pruzanski, M.D.

is part pruritus respect agonists, the with mechanism studies is seeing that we're It know. it, We've you don't activate receptor unknown. know. the competing in short possible of second is going other but the until to then populations, see patient to that said answer longer-term PBC not question, could we And and FXR theoretically Yeah. we still the of without your before just larger, other

talking been several and depending purely we're if seen, FXR have any on be which it these about, have synthetic engagement GI We we're be diseases. FXR also about, hepato-protective the and several progressive that in believe, stated agonists to the see so remains effects forward. target we agonist we've tract that of the liver, failed kind have non-viral absolutely FXR of historically, which And talking to in demonstrated that liver necessary is will both viable there going

Unknown Speaker

might I read-through the that Okay. that decision or XXX's the liver a TGRX requirement injury? trial, a what or NASH how about profile you there I'm it's been other on seeing an else? is related in if maybe the real-world amendment. there's And FXR that agonism patients you. guess, setting what could monitoring lastly, for about the are Just are just hoping you've quick, its whether expectation with REGENERATE that's to potential to have preclinically de-prioritize also, curious about, rigorous thinking and anything potency Ocaliva agonists, And what differentiated? would if a clarify Thank saw to for wouldn't, be competing XXX, anything guess, Thanks. And I I in the bar was monitoring the in monitored high FXR label be thinking just requirements profile frequently you then

Mark E. Pruzanski, M.D.

Sure.

our as one really data that decision The frequency OpEx profile non-liver, asset long preclinical to felt NASH in-market claim different resources in OCA. REGENERATE. So decision study mentioned, we don't extensive X proof-of-concept to I With your is the animal – mean, liver with of that's not on patients. differentiated – and that superior has look we've XXX clinical And to on a we as streamlining we in respect sorry, said, diseases, to – in have yeah, the and – different XXX, respect models, obviously to prioritizing based of that OCA. de-prioritize, the asset Phase to right, substantiate and our have

of clinical have we look, So ongoing a trials. number

our mentioned on with committed our studies across to have population, patient marketplace in to Ocaliva our clinical regime safety trial, a up As on September in it and safety. vigilance PBC clinical stepping specific our the monitoring safeguarding safeguarding in trials. about call, patient not given a I say also we suffice in can't but I monitoring comment that in only good our feel but we the XX

Unknown Speaker

Great. Thank you.

Operator

you. Thank

Our next is from Cowen. question Baral of Ritu

open. is line Your

Ritu Baral

Good question. morning, taking the for guys. Thanks

First you the for with the even Can void go follow-up. and any monitoring REMS label might mentioned that a how on either patients. or question is into a detail into on play update? a to that And guys little Interconnect I then have more potential severe enhancements for

Richard Kim

Hi. Richard. Yeah. It's Yeah.

concerned, daily differs more enrolment as on does or a patients. adding non-advanced patient mostly So obviously, been have clarity far discussions, and how less and capturing nurse far I form Child-Pugh driven is as dosing education our C is the on as label to clear go have there the as outreach FDA can't really Interconnect coordinators with And have Child-Pugh also a on B we from initiation speculate already, we and or forms for Interconnect how actually well. articulate patient weekly dosing a that having status. on of – B C the to patients Enhancements care we're that coordinator as obviously, our will to to when but are what titration that have

the we're going well think I the the that we've beyond, been proud and really, I far well-received the there. vigilance I communication think thus about has that above knowing feel and practitioners, really So fact by pretty added really

patient. Child-Pugh we're a – essence to just around reminding looking people that So have so forms and capture a there's tweaks the in actually B even to couple prominence how C to more of more

Ritu Baral

And that these is FDA are aware of? enhancements

Richard Kim

the they're have clearly and Well, do aware the what notify through our actually today. of support we when we patient promotional materials do but that of product all actually for we Ocaliva so our don't not actually services in specifically, marketplace FDA, materials to our mention

Ritu Baral

mentioned my Got populations? reaching changing between populations populations out we're rates messaging in are three Ocaliva prescribing specialist is versus physician last behavior, between patient who the the or you two guys to have approach hepatologists, those behavior believe I talking prescriber been those community, saw follow-up the how difference as intensifying to for there the the if you guess community it. a guys I gastros And now you any then refill difference that messaging, was that months. or for for prescriber and six you Insofar cared you the by whether are

Richard Kim

Sure. That's a great question.

the they're on by between we first. and hepatologists. are treated the and goal PBC, on very just on impact little to more sure a make spend we differences on disease of the But see with would take focus probably is still than But general journey of the people I less a physician patients get progression every What impact always in really that patterns focused them the lot gastroenterologists out say and gastros, time and gastros community of with before see even that our mostly the is generally we disease want to, lot in more country. the the we and was particulars would case sort on So of into products. the to that we our hepatologists we of truly most the focus overall don't first and whole there's really because in because of I HCP generally, a say that reach

So to really and everything well. that our on that's changed gone commitment as made hasn't PBC appropriately, is commitment well-recognized sure we've here really our throughout make really been it's

Ritu Baral

it. Got

If question. up guys year. that indulge growth? me could I last with time see European leg next midyear next You the Lisa, discussions ex-U.S. mentioned Lisa. should by one do This to you it's reimbursement of for you Where next, guess? wrap where

Lisa Bright

Yeah.

to respect reimbursement our said, and EUX So across the really progress pricing you have, as I mean, we made Canada. with good

Of Most regional-type national have countries, kind access now first and of know, to we pricing discuss course, step. you'll reimbursement the as at of securing level. these is a

major across where outside Europe. kind basis countries there opportunity. being of be that's obviously, a next on smaller and, we'll So country-by-country And of going we the us really the out focus to of that, then some see work for an

call filed and I've pricing now on the example, and our an for making we right on cementing markets Israel basis. reimbursement. progress mentioned the look focus continue So last But on a been we've in with based I we'll at think, to just national good as really individual-by-individual is strong really launch

Ritu Baral

you. good luck, Got it. And Rachel. Thank

Operator

you. Thank

Huang Ying from is of America. question Bank of next Our

open. is line Your

Aspen Mori

Hi. for taking question. Thanks for It's on Aspen my Ying.

trial information? or seen do have example, the given Thank after safety the well? For been ask any safety monitoring you. updated, patient safety issues recruitment latest guys every since communication? on consent the has you And to from So REGENERATE as reviewing in on the have FDA protocol you impact REGENERATE again the to

Mark E. Pruzanski, M.D.

we the it So, over rates randomized September our mention trials, call also we comment did in not REGENERATE, only recruiting I have Phase don't but the trial, on X far patients by ongoing largest. XX well X,XXX making clinical that on NASH onto but leading

to that with We your part first the on of analysis another I continue had interim feel trial the of of XXXX. track in you is think readout or? question, projected confident half the And

Aspen Mori

been the updated to wanted for REGENERATE if given protocol communications. I the Yeah. monitoring new ask had

Mark E. Pruzanski, M.D.

Yeah.

taken trials vigilance across As opportunity I a up to minutes clinical mentioned of ago, our we've of couple all the step ongoing.

Aspen Mori

Okay. Thank you.

Operator

Thank you.

from Our Oppenheimer. Jay Olson question of next is

is open. line Your

Jay Olson

had follow can the up you that lead taking analysis I expect FDA committee provided? a is my it on would on any to all there Is just color do reviewing label just factors question gating you Sandip. Oh revision, guess hey, Or you've matter I provide meeting. guys. data additional an questions. label and for the a that to up Ocaliva for the And the FDA Thanks the revision? advisory then of

Mark E. Pruzanski, M.D.

We have indication advisory meeting. no of an

As with constructive the the label discussion are about we I update. agency mentioned, in ongoing a

the and both favorable of confident benefit/risk good profile about provided remarks, my have all and drug our with We remaining in of I we feel information the mentioned them prepared and unchanged.

this year. So to discussion on finalized, align update with year-end if then the the by the expectation get is appropriate label we'll early that agency, not and that through next

Jay Olson

could operating was the that objective? just growth with made of behind and Sandip, wish the Thank Okay. streamline Rachel. goals all stabilize just share comments to operating are about about expense wanted about the for us the there to I curious you is growth? in And talk expenses. factors And Can of terms you. And the any best then maybe to some of you what then I also, objective

Sandip Kapadia

question. Thanks the for

on guidance I just further I our provide year or And go a to – mentioned, we're addition as this I process expense operating growth look, any mean view. embarking reduce at into is next think, As to we point not.

streamline to Our as overall. objective company just operations, programs generally would any is do prioritize

mean, have has it's more an to organization, because our a as more programs prioritized basically just I and so. company have things, So and just now we become as need focus more on we

Jay Olson

Thank you.

Operator

Thank you.

Our from Stanley. Morgan next question Andrew of is Berens

Your line is open.

Andrew Scott Berens

REGENERATE the at Thanks informed patients the wanted investigators question. drop Maybe then just circulating to there issues Hi. and taking also phone opportunity two COBALT the trial. and I safety questions. the the enrolled a the concern them the had for Meeting, of to of out offer ask and was Liver to

like know And enrollment dropout after the in rates, I'd actually about services was trial. but you to that has I you question whether a case ask either on do NASH trial. also the then said And increase a communication? I that talk there wouldn't been So have

Mark E. Pruzanski, M.D.

entirety of your about dropout XXX Andy, in the rates question, I in talking REGENERATE didn't the but trial? catch you're

Andrew Scott Berens

the then either And REGENERATE that whether an confirm drop to or wanted you patients case? them of that COBALT. safety were enrolled opportunity investigators in actually phone out heard and trial, in had increase in either have dropouts the had the seen the trial? the to about communication, so in trial and to the offer We Well, tell I that was

Mark E. Pruzanski, M.D.

out Andy, mentioned up confident as said, Yeah. ago, comment ongoing couple remain on minutes of to I we of vigilance but specifics patient I'm that safety on we our trial, stepped any all having REGENERATE as we're programs. across Look, track a going have we've very is to read in not in With first May actively enrolled the back the outcomes patient already of study, enrolling enrollment, on on the analysis in of right half now to track. cohort that's XXXX. the interim respect cohort fully

of part you NASH Second mentioned your a question? question, cirrhosis

Andrew Scott Berens

trial? at they Right. is see that start wanted company? have have up Or a FDA starts? whether endorse And IND I Do completely have or that not to to the in in does place, – this actually guys role obviously and you point an trial to the that the of

Mark E. Pruzanski, M.D.

coming FDA trial. a such with with back the of function of trial. discussion I a the mentioned, And be it's as we'll about Obviously, shortly No. any details

year-end. will We it prior be initiating to

Andrew Scott Berens

lot. Okay. Thanks a Appreciate the questions.

Mark E. Pruzanski, M.D.

Thanks, Andy.

Operator

you. Thank

Alan Our Company. from next of & Needham is question Carr

line Your is open.

Alan Carr

taking if could questions. Hi, my about the a guidance Sandip, bit thanks this I for you wonder clarify for year. OpEx

sense to fourth if believe clarify said like looks just sort was Thanks. pick cirrhosis – I continues? similar quite entirely there EMA you it you that the the can also over around trial some events a increase, the process another warning that of that I XXXX impact some letter. that's going here mentioned And a wondering U.S.? of I get the the of to into up and the underway the want if bit whether spill was You it's review in one-time reported a then of some in quarter. that Is one trial. as would forward of with to And due

Sandip Kapadia

Thanks $XXX $XXX start X mention middle quarter, one-time your previously Phase No. there the look, up mean, I we fourth we I look, a us in question. see major basically expenses that we think some with And the I generally this provided guidance sort said would of did that we as million. you point that to for program. What comfortable be, have are was, million from in coming the of at range.

position this in provide more So that I'm I think to really a something. point, not that's for XXXX. guidance At

certainly was effectively costs. follow fourth but quarter that the right driver the for at we'll those up something of think I some time, that's the key

Lisa Bright

Okay.

to this we what suspected in what's supported adverse label. the regulators a treatment to as use allows At new be stage, additional second to obviously, and and assessed. designation, I is The an a appropriate Europe probably per that which with not call swiftly label, there's work any discussions asked this encourages monitoring events for triangle Europe, changes. in around any But we've case evaluated conversations we've to and the asked to in any we've and mean, the been point, question, make know, been regular we're not to sharing Canada. I them any been think make important We've black in by of continue to course, been of educate the them that's the doing reporting effectively clearly any changes which at with

Alan Carr

much. Thanks Great. very

Sandip Kapadia

Hi, Alan.

I really as certainly that's about XXXX, process maybe expense said, But operating to growth our Just right so reduce also so. provide guidance. I now, that doing a think you something also be can't briefly as as XXXX, into on go to up we're mentioned, like overall, and follow just further we'll I we

You mind in to just keep want as that well.

Alan Carr

All right. Thanks for that.

Operator

Thank you.

of Our Partners. Schwartz Joseph next question Leerink from is

Your line is open.

Dae Gon Ha

quick Two This is dialing Gon Dae Great. much Thanks for questions. very our for taking in Joe. ones.

sufficient where update on change to from occurred previous for to you EMA so with Phase terms made? needs of what up So trial? in AESOP the also, on pivotal second compound the of for as trial, could the question, be EMA the AASLD that EMA on And or been the of Thanks. actually just I the following said that any necessary not no but know further up ALP process, label alone review presentation there on when X the following us provide has FDA previously date meeting reduction mentioned the endpoint, the is sort an the question an ALP exact you reduction can a

Mark E. Pruzanski, M.D.

necessary, a to but out. We that a detailed to yes, a to is it was go questions. as paper both an EMA the as pioneering is but we're support with letter appropriate path say at that insufficient my remarks, now Lisa that workshop last timing forward. mentioned, discussion year. likely the regulatory indication can't in take we believe forward will I'll on PSC AESOP, understanding in will suffice we that, FDA-hosted early regulatory With I mentioned arrive third the soon correspondence, path of be some specific going take dialogue, endpoints prepared published be the alk results not held respect detailing But approval. to FDA of comment believe, It's of again, here. to My requiring to Sure. phos do

Dae Gon Ha

very Thanks much. Great.

Operator

Thank you.

next from Our question Joel Beatty Citi. is of

Your open. line is

Joel L. Beatty

and growth taking who or question's on for lower yet, for prescribing PBC. how not force? are further already The sales that's Could it physicians to Thanks high the Hi. the Thanks. you of are opportunity among Ocaliva question. who in affecting the compared discuss physicians sales the prescribers focus

Richard Kim

for It's Richard. the Joel. question. thanks Hey, Yes. Hey, Sure.

of far out the continued would say POISE parts now. initial as very the in So treated patients much of generally our as right patients there is we growth aligned seen concerned, to launch, so as largest have I criteria the population

by an used obviously defined not to have allows us UDCA, inadequate who alk or patients is phos specific which in be intolerance Our response level. a label to

we patients, who slightly probably know even that levels. are of currently have So alk lots lower the in phos high-treaters there

of beyond audience ways we inch-deep-mile-wide we bit So of offices looking whole an well. and at then opportunity continue, really And a are jumped has in been who quickly. a we growth impact marketplace see on our those quite as in this still Ocaliva know that, phenomenon, actively a that broader target to lot expand

garner well. still and to already who the feel good new Ocaliva we as about experience into our have So opportunity go within to come treaters in mix deeper those and gain

Joel L. Beatty

Thank Great. you.

Operator

Thank you.

Bayko question is Securities. next from JMP of Liisa Our

open. is line Your

Liisa A. Bayko

my been know have you. answered. questions Thank You what,

Operator

Our from Securities. Fargo Birchenough question's next Jim Wells of

line open. is Your

Unknown Speaker

Yannan is question. Hi. Thanks Jim. taking (XX:XX) for in the for This

is dosing. trial you difference. PBC, study what of be process know the thoughts, for on how your talk and patients daily, could the the you so to in weekly be share used, trial, cirrhosis think cirrhosis dose but patient in a Because these NASH in thinking used obviously be the and the I of thoughts in design on levels on about once big you would some exact that's to NASH wouldn't terms the your thoughts dose potential versus it? about specifically question First dosing? dose liver-impaired and In once about

Mark E. Pruzanski, M.D.

NASH the thanks for study. interest cirrhosis in your Well,

on specific today. As back completely to specifically, different dosing I'm to impaired shortly talk be to not I questions though, the trial design, about mentioned, number to and with want PBC I do with details say, again, coming we respect reference so disease, one. your patients that hepatically will going

you NASH exposure cirrhotics to NASH it versus the impairment. effective compensated So hepatic X with the of then, be in patient in will at study, very Phase perhaps different respect liver with patient. have or dose a mild PBC upcoming And a also, no most cirrhosis

more So different disease. the advanced very from with stage patients decompensated, significantly end again,

Unknown Speaker

And Urso. in I (XX:XX) kind is discontinuation That's is PBC or persistence rate another commented on patients. very similar the which question helpful. know of to for you on

have that the on Urso per level at the stable and week, that stabilized similar looking kind safety rate? as XXX is script it Just discontinuation week of patients new discontinuation. the seems at level, well, added to letter, every seems like to Urso given you to scripts to somewhat were prior the some historic the discontinuation, there's level Could comment whether

Richard Kim

Great points.

might you reinitiate. office. specialist and, months And, patients get to they you directly some in physician get before through recurring of see right refills away. would into the to could I the have have sometimes say quickly cases, can't Generally, the waiting their in see it is consistency in seen take as mention not patients who last prior of are I as some we rate from back couple and as we're what the that earlier, generally we of So weeks hearing exception see. we would a is higher did Urso our remarks, normally what weeks delayed some know, see take to services It a with with

out. So I physicians that its think still. the general But I filter one well fundamentally product belief overall have things in think from way as is the the heard sort we some in that's important of and the of will this

out for I well. some but will also and some I time physician do some So their sort of think back it here, time get take to these see think things will as patients

Unknown Speaker

you taking Got the it. questions. for Thank

Operator

Thank you.

Brian from Our Baird. next of is question Robert Skorney

is line open. Your

Brian P. Skorney

question. guess the I around with liver impairment. discussion that have did discussion call, five the There September hepatic not the was three guys. assays the taking around the for morning, good some on Hey, of patients patients. Thanks

think I you that of any weren't you all. or there just those whether information five were confirmation or think other patients not at wondering Plant time. actually really that PBC believe at of were patients. uncovered details just it if, on not was given say the you had two cases I that (XX:XX) there those if PBC was said on then that wasn't A, And guys Thanks. patients got I two Dr. that, two whether patients. I of that two information any any wondering cases you

Mark E. Pruzanski, M.D.

Thanks, requires the underscores the Yes. think into that how of at careful being to it in is complexity the just Look, reported cases here. details Brian. these post-marketing into just alluding adjudication. the follow-up database. a and you're again company fraught Each FAERS I lot very There's look to case

appropriate been back into and expert of these individual our of re-affirm adjudication we'll time, external benefit/risk you now come cases. more in to we about and to into go As the once reassured and reported experts the and then back cases, update to Not that the these away other at of drug. detail now have going it I We'll an prepared my talk mentioned out. today in we've has in come with label completed where the we belief finalized, been FDA come quite remarks, our findings

Operator

Mr. to I'd the remarks. for this turn like Thank to time, you. call At closing Pruzanski

Mark E. Pruzanski, M.D.

I Phase that's in a you launch label NASH on OCA we coming to for optimizing half and PBC readout laser-focused with forward just liver PSC of Ocaliva then to you on forward everyone earnings Thanks look XXXX on want next Yeah. advancing of worldwide and program first that and for atresia. and going course listening back first-data leave of call. today. NASH of to like in in remain focus our for leading X biliary the track diseases on non-viral expansion progressive our message other We'll the

Operator

conference. today's the in participation your program. for you This thank concludes gentlemen, and Ladies

Everyone disconnect. now day. have great may You a

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