Intercept Pharmaceuticals (ICPT) 2 Aug 182018 Q2 Earnings call transcript

Company Profile

Participants

Mark Vignola	Intercept Pharmaceuticals, Inc.
Mark Pruzanski	Intercept Pharmaceuticals, Inc.
Richard Kim	Intercept Pharmaceuticals, Inc.
Lisa Bright	Intercept Pharmaceuticals, Inc.
Sandip S. Kapadia	Intercept Pharmaceuticals, Inc.
Michael J. Yee	Jefferies LLC
Jay Olson	Oppenheimer & Co., Inc.
Salveen Richter	Goldman Sachs & Co. LLC
Beau Miller	RBC Capital Markets LLC
Irina Margine	Cowen & Co. LLC
Steven Seedhouse	Raymond James & Associates, Inc.
Aspen Mori	Bank of America Merrill Lynch
Joel L. Beatty	Citi
Joseph Stringer	Needham & Co. LLC
Dae Gon Ha	Leerink Partners LLC
Yanan Zhu	Wells Fargo Securities LLC

Call transcript

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Operator

Thank you for joining the Intercept Pharmaceuticals Second Quarter 2018 Financial Results Conference Call. All participants are now in listen-only mode.

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

Mark Vignola

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

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

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

not or OCA this In any begin OCA remarks Mark Pruzanski; your the Sandip can PBC. by Kapadia. our for addition, open take that or Bright; cholangitis time. please and CEO, Marketing, President, call safety from of Richard to by other Today's use Financial for note from Chief call indication the International, has and regulatory for primary indications Kim; U.S. President, will with any is investigational any at concerning other biliary efficacy than then our our Dr. No conclusions product Strategic been drawn be approved that followed an those our Commercial Lisa We'll questions. Officer, authority

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

Mark Pruzanski

morning, and joining Mark. us everyone, call. today's Thanks, you on Good for thank

completed, XXXX and with this been on the our Today quarter These worldwide infrastructure, with an has The strategic continue Ocaliva XXXX across set net happy first recently happy approved reported our further to accomplished. sales our a we has half stage PBC team been all growth by exciting bolstered the for I'm I'm report we've priority We've to and markets. efforts good made of our expansion business. in million and our initiatives progress have launches progress of of that one. $XX.X what second sales, in

represents to realize PBC We continue geographic opportunity. intend to territories that multiple believe opportunity and fully that we a robust across

in Richard of later sales. in Ocaliva guidance We are XXXX $XXX net and million further today reiterating between our million the Lisa details will provide worldwide $XXX call. and previously announced

currently any that and and the approvable To provide two across investigational a all the clinical therapy to foremost, data have PBC, we has inform believe Ocaliva NASH patients shown our improvement, will to second, competing to to the only set remains clinical most is which fibrosis outcomes; physicians date, addition to our efficacy program. treating highly Phase We work with patients we bring industry-leading key of liver NASH. shown advance believe continued endpoints: can which with on X been therapy NASH to predict resolution. In histologic program, of based first both OCA the that desirable to be attributes features these robust

post-marketing readout a clinical REVERSE interim comprehensive As NASH with compensated continued and outcomes supporting patients on patients NASH follow-up you our initial analysis flagship advanced REGENERATE on designed regulatory benefit Phase REGENERATE confirmation may with recall, with fibrosis program and our includes is fibrosis cirrhosis. the X trial is in on in basis. to an approvals for of the trial trial

generating We of remain readout half XXXX. in of from reiterating a the line results top and robust our analysis are data, first the on focused continue to guidance for interim

Our positive data will Phase be cirrhosis. to with is safety and designed the of patients and commercial broader NASH. trial that and evaluate in efficacy NASH REVERSE enrolling, X is OCA REVERSE of we currently compensated believe efforts our supportive

to our defining and in involves OCA PSC. franchise, work the path for near-term this expand cholangitis forward primary a sclerosing and Finally, we cholestasis to or continue

there indication We therapies. continue to are on regulatory and work with thought approved where no authorities leaders this

As with the remain half of execution with look important in to the goal progressive mode bringing disease. we patients second of we liver a medicines XXXX, to

NASH. our U.S. in focus for development over it our execution PBC that, efforts Our efforts the turn driving in commercial on both update. remains With exceptional Richard I'll commercial to in and

Richard Kim

good everyone. Thanks, and Mark, morning,

reported we quarter, second $XX.X million the in net U.S. For Ocaliva sales.

our to with quarter. which in compared volume pleased the execution, growth are We first resulted significant

we With foundation our second saw highest quarter, we we this forward. like our business a for More business, in of in level we importantly, to substantial going and base, a since total prescriptions our achieved solid return feel stability the have quarter launch.

were our by force adopters sales QX will knew of to return of implementation that expanding our and sales early included treater a force group was mostly base. driven stability our one (XX:XX:XX) our sales of been our it core While who is we physicians be believe has key and the expanding that driven initiatives which launch, team. growth at approval, the expansion our base contract to we efforts, expansion time to post expand our existing in longer-term central our by of treater

and now have have we by This patients. more completed which includes is more physicians, these XX%. reaching We our customer critical far PBC about coverage believe to community-based increased GI updates reach

to our our patients less physicians In PBC. and generally PBC been need team potential educating community-based core the in physicians, calling out to as has physicians on identify addition with are newer these familiar unmet on for Ocaliva, how

compared and sales force and their have messaging initiatives in patients of physician time and attendees we calls already our We noted was the takes some sales several efficacy and our begin focused all significant to visit to increasingly average, seen grown, there growth interest months, overall change importantly, expect to X behavior. in to versus to non-users. to Physician our have programs and, QX. half QX. will our PBC that very a Because nice our is increase every Also a QX on second in our contribute expansion efforts users in increase Across as prescribers we physician speaker both in QX data XXXX. in first-time it XX compelling we has very

our to We our brand out PBC our and support well. material have new Ocaliva patient increasing rolled communications as promotional messaging

patients actions beyond for We been ultimately therapies. be note more our to to customer-facing fewer we has physicians in a will effectively initiate and half reach challenges months the patients The when in many treatment new may efforts. year PBC that us time critical our of to that option. move a the allow recent believe past of on are who and need our summer first tend us enhancing focus We

stage Lisa. the for we very However, have your and about like Thank we turn do to over sustained to feel call growth. set the now for that good I'd attention you

Lisa Bright

good Thanks, morning. Richard, and

the in very which Ocaliva international the contributed sales of performance encouraged net the million by second region, quarter. are We in $X.X

from Whilst and As expected, are year that Spain, launches from the doubled December this data Germany mostly an the do as since prescribers in our with performing the prescriber last UK that Southern Canada. earlier also sales of in number we Italy, of France has The have we and level regional access. Portugal of we the strongly contribution international and estimate international we don't year. are Europe, increasing in U.S., secure

could occur us number previously access to the who across help not without international reach process national meaningfully. forward, of important Ocaliva our private support the efforts year. through We provinces the we As of a in negotiation Canada, should of public will to insurance. which look Reimbursement access we half events to that expected the patients completed XX% see allow other territories is second and

broaden In take to addition, significant access to will we steps continue to Ocaliva.

we This regulatory quarter Australia. in Switzerland and approvals received

end in expect XXXX. of the Australia sales We by

during We quarter. also first in achieved Israel this our sales

as learnings from leverage Importantly, enter we are the able these we countries. launches early to

the patient are essential recognition publication. encouraged particularly that board are to the in guidelines PBC reinforce clinical time community, for management the and this disease. EASL an the to the Within of physician of governing guidelines approved patient the unmet and the we broader patient the discussion for help first need version tool These

is for major a that our are funded accelerating new optimistic which call doing our I'll So European not about all and Sandip. we access continued are with in the to in over Ocaliva, this starts summary, growth and And international in patient Canada. countries to year of great teams hand job

Sandip S. Kapadia

XX, quarter financial today and results like I'd XXXX. our Please of refer to the the summary to earlier June Lisa, issued for you, morning, you of opportunity and good cash to Thank give the release total financial second ended everyone. net $XX.X our results, quarter for take XXXX. guidance million including $XX.X press a Ocaliva revenues of our sales. QX million for an position, our update XXXX, in on recognized our XXXX in We

net sales million. quarter range. and comprised end deductions the net Ocaliva the of communicated of were Gross to to XX% million lower sales towards of net XX% ex-U.S. our $XX.X net previously sales of for were U.S. $X.X Our

and total were adjusted were for million which million. GAAP stock-based $XXX.X $XX.X our and expense expenses, exclude quarter compensation operating the Our depreciation, operating non-GAAP

$X.X of cost quarter Our were for sales million. the

and previously As the our the Ocaliva, launch commercial expensed prior of we discussed, to related supply. approval manufacturing buildup Ocaliva to of costs FDA

a of until expect to expensed As sold. of remain we previously supplies are sales result, Ocaliva negligible our cost the

million convertible expense our We also notes. the of to $X.X quarter for outstanding recognized interest related

we in summer to our $XXX net XXXX net and $XXX guidance, our in million. reiterating seasonality typical full to our approximately of the guidance And cash investable to on see on available million. offering previously XX, includes we in we concurrent completed from Moving are equivalents June million quarter, which third $XXX.X in our cash, placement and XXXX Ocaliva to of April finally, the million our sales public sale expect XXXX. cash common XXXX, financial securities for we of $XXX.X year the moving private while range stock position, This proceeds as of announced have

XX% to XX% to We continue gross year to net be the expect the range. to for in

XXXX $XXX In announced we're expense million range $XXX million. to confirming addition, of our previously between adjusted non-GAAP operating

full For $XX the the of component year, includes convertible our of we interest million expense which interest outstanding notes. and approximately expect amortization cash both

reminder, adjusted a under over this of a Please refer operating to SEC to measure. explanation an Finally, Operator? expense call that, like as press non-GAAP reconciliation measure non-GAAP is turn release With operator. for I'd the regulations. to and this morning's the financial

Operator

you. Thank

is with Our first Yee Michael from Jefferies. question

Your line is now open.

Michael J. Yee

on half feel data, to and and question investors and data think is coming or can out contextualize towards guidance data this FXR The coming good in of talk congrats should coming study. of all get seems quite going are assumptions competitive in like to that your Maybe, beginning which in related as what guys. Two whether what questions first we think it at later drive getting data, XXXX. is would the people the REGENERATE first Mark, half. broad we're towards this the Hey, that? as I how the the innings at should on team general that FXR others half first AASLD are guys. sort the of Good getting on guidance versus to how that second One obviously and the morning. about you would that. of for range closer – the on Mark you data, the later relates first the the data just And half and was quarter. to of in a you

Mark Pruzanski

to as I is trial mentioned that data reiterating Sure, a competing the endpoints. FXR molecules, prepared the Mike. on Phase there's Obviously, one's from of up agonist, non-bile in that flagship robust are, most due readout population at scrub I we to time idiosyncratic respect of clinical take more generation in we've what to current possible, them that to – data later to remarks, based there's to We've through half. us fallen guidance on much needle in far first no early I focused pipeline. in X but make seen of sight to believe through the seen our or both that first away this anything we're looking compounds the for XX-month that readout. get are yet got getting does stages definitively database associated mentioned patients study, now. and respect very to development we've in number FLINT is this our a It leads getting on of This right that case, to REGENERATE, any going to my with lock a each those over FXR again, we're the tighten so of call lot robust have of aren't and world. Thanks. in prepared differentiated acid to of the patient to this point from OCA biopsies five issues is It's mentioned as our forward data years got there, there of from we into study more right? but to before that around for not In the from the out programs our coming we're trial. truly With it, out coming year. moves than a huge guidance. haven't not to And, us. I've harder remember so various anything the we And one the preclinical massive a With say coming an one which crop confident nothing

Michael J. Yee

Part update issues patients the up absolutely timing how has your around like ultimately drop-outs sort in brought all re-consents the you changed not just anything either Can and a earlier the and were I question? the first impacted REGENERATE year to needed clarify ask one Do of may for like feel thinking interim is view and follow-up hit guidance that timing. of have to many to dropouts were that or the that assumptions that safety those that?

Mark Pruzanski

confident readout large remain on possible. remarks, robust this all in mentioned study. but as again, are Well, them my we studies in dropouts, do, the to I generating a guidance well-powered the study both of look, like prepared absolutely we This of our data And very see most is for endpoints. committed the

Michael J. Yee

Thanks. Okay.

Operator

with Our next Oppenheimer. Olson question from is Jay

line is now open. Your

Jay Olson

Oh, had taking by was FX landscape. reducing outcomes mostly and if you and it hey, with consistent of driver the FX that was wondering burden guys. that, NASH conclusion and view of in cost showed I in Thanks and the as primary and if driven I $XX of is if questions. economic your which FX study FX a was utilization in seen DDW resource fibrosis the the presented patients healthcare had for NAFLD of clinical patients. impact wondering was you the seen a billion U.S. that at on real-world June, the

Mark Pruzanski

did the a epidemic. see question. on NAFL of reconfirming keeps We it. body really research proportion the – There's thanks. growing of epidemic NASH that Yeah, the Appreciate

preventing this and as you that that I do Based it's underlying intervention. on a at be correct research, end again, again that clinics in only need, patients study, with FLINT the therapeutic therefore, the focus to fibrosis the hepatitis. to are for and of driving of to public there but mortality. independent the think fibrosis is that's I it health to call to a true. least that their of is only driver. resolve as who that is see this, focus day, feel what therapy has patients absolutely advanced our seeing NASH what out burden market really deluge patients cirrhosis fibrosis and all-cause I a both. to really study mentioned both, liver-related in of with fibrosis alluded our But key on cirrhosis product compound, keep progressing remarks, At And appropriate, just can would for they're here, where happens the clear drug why ones also shown that's are has believe focus investigational the Study the and because we the both NASH And initial, can these stage the there's features saying to to really, this stabilize on Right? very a the clear and state we ability on is critical demonstrate what that what's we because biggest love healthcare a OCA, – And not outcomes, being association is fibrosis of the reverse the is driving impact prepared able benefit on the here, system. you after do in one, today demonstrated my physicians resolution. that from

Jay Olson

quick just a Maybe up. you. as Thank follow

as One indicated in show favorable NASH his of at OCA prevention analysis of authors pricing a treat that and of price reimbursed to that NASH? economic cirrhosis and study outcomes $X,XXX economic approved consistent reduction wondering you out of pointed the a and drug fibrosis be annual analysis, progression of significant according did net your I that if to for that's with with was could

Mark Pruzanski

going It's comment pricing now not really premature. right on in to we're Look, NASH.

Jay Olson

Okay. All right. Thank you.

Operator

is from Salveen Richter with question Our Sachs. next Goldman

line is now Your open.

Salveen Richter

Good questions. Thanks morning. my for taking

evolution come should we case expect here? overall the not here, have biomarkers on you link whether or fibrosis that Anything NASH general, the and I and fibrosis your And improvements, NASH follow-up. between questions And here resolution is just the the will a on of improvement the, that resolution here to see data on set? process or process necessarily in just going if whether one surrogate that thought two thought study. the landscape you're REGENERATE on So then release between

Mark Pruzanski

Yeah, thanks, Salveen.

non-invasive the means So can't for of which fat, we, the and resolution X – non-invasives currently on respect but NASH I of look, assessed doing, of specific And the will think data only we fat happy evidence speaks time, promise out and the And and specifically between non-invasives define predict as to hypothesis know these that a microbiome, part MRI-PDFF, certainly, irrespective think here of studies show see right resolution data at readout you we over and in in lot certainly that their going hepatocytes of line which study, resolution, on which inflammation resolution, there, out the that incorporated first then the ought ballooning I any of resolution in assessment to have subset of right to hypothesis yeah, – been as is tell incorporated now biomarker the was feature of to answer in is FLINT correlation disappearance and to residual you NASH robust that right? is robust the to predicts, just But number – yet. least or set, the coming in and In, which example. there's endpoint. biopsy, but no was or it them are data any initial and some one have has now imaging is With correlating them. I what context NASH not what Phase to FLINT we turn not steatosis, with what and improvement don't everyone respect REGENERATE, then in sets, top reading in with that we fat just can right lead of other I'm as you if fat both From what be any question and eventually and liver, shows on that we'll measures the one a has correlation a frankly what eventually histology including non-invasives. NASH that between content able fibrosis. NASH recent correlation a that and show we outcomes. nobody of not achieve necessarily histologically asked data to of now we'll really follow-up

than of definitively been more NASH to to fibrosis the I think hand come So and non-invasive again question the and back definitively have there's on really jury's and very been out, premature linked answer advancement the outcomes much resolution. it's investigational your right already marketed now markers in that terms the I of and fact to other fibrosis

Salveen Richter

gating Ocaliva recognize but that Great. PBC, And apart you're a been in has to the the their half and the and from uptick getting expecting here? stabilized follow-up really second an just of factors more on an trajectory label I uptick what have

Richard Kim

Yeah. for Richard. thanks And question. It's the Hi.

options we had it I very remind has think always PBC rare XX would disease I sort And no that a almost rare think because commercially when about myself So years. that for it's of new a (XX:XX:XX) say, sensitive. I disease it's is,

focus now year. spread reach half expanding we expansion why that's initiative is – a more very lot important know gastroenterologists, for was first a our Our of and us the this throughout because are community-based really covering a that in force and really quite patients sales our

We coverage takes calls But I also start it say saw last than behavior. physicians, launch. platform have we year for any since the more second in it growth as in going really by of really for our of well. can reaching we to a that to having previous forward half is several know these that calls made And we continued what quarter do quarter is and generally and in change the increased more believe the us

Salveen Richter

you much. Thank very

Operator

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

is line open. Your now

Beau Miller

competition of the but Yeah, of on give safety. just guys how your latest growth Can you're can you call can of there? net taking on hi. what seeing expect you there price in and us updates long-term dropouts, Brian. And on of liver have impacts my to maybe little forward Thanks we gross bit I think also spoke talk in earlier a question. that increase a Miller the revealed? rate to in going on light the similar you then also speak terms assumptions on July, also price the the is And ex-U.S., about DSMB what Beau This for the forward? rate for going that you on Can latest increase?

Mark Pruzanski

And the the studies. I'll regularly There's basis report past, to Sure, that's than I tell from NASH all now on program running that don't can alone question untoward in tell that of mentioned you DSMB I've number DSMB. any we we bigger reviews least first a of tally of Yeah, our and nothing but out take the can terms put competing is latest of enrolled. on have enrollment, I a part now as you ongoing review. – REGENERATE quarterly of out the there meets in patients our at

gross So, feeling With to respect over there. net, hand on I'll we're where we good Sandip to based are that. for to

Sandip S. Kapadia

no. and in gross the range, incorporated mean, guide terms XX% guidance. impact we XX% was any the net from in I continue to towards of our price Yeah, to to

Mark Pruzanski

And then could was you the make third part comment? of international a your Maybe question Lisa, competition?

Lisa Bright

Yeah.

there apart are patients other So, licensed PBC. of options for mean, with UDCA, from no I course,

get the Ocaliva so is obviously contained either So of very our is UDCA who of to optimal off-label products, unable number promote amount tolerate on for response. focus but that's to don't investigational are of to or continuing to small There label, a a who very an use small patients those patients.

Beau Miller

much, very everyone. Thanks Great.

Operator

Baird. Our Skorney next with question Brian from is

is open. line now Your

Unknown Speaker

(XX:XX:XX) Trevor question. Brian. on is Hi, this Thanks for the for

study? REGENERATE Just if data blinded you at this the any Thanks. statin point in discontinuations wondering implementation have on and

Mark Pruzanski

we is study The blinded. The is short answer don't.

it, the to means study this originally are could that design As could real-world study you which a as patients is we close or know, on be randomized statin not. a in as who

had guidelines a the the course to at guidelines the the study, and in use specifically a post-hoc where at study be on and and we over what stratifying on atorvastatin looked the of Phase in readout we data in only from combination local atorva, the X follow, we you XX that that and not can is in who Patients OCA, We the look retroactively management But FLINT, really dose reproduced just protocol the we different and have control that end saw remind and with are if a put in to that the AASLD of not are of prospectively we well you OCA doses I'll patients the does or what trick and low end, add will it's there's EASL LDL, statin last year, of and cholesterol placebo of at population. consistent safe atorva to tolerated, managing for statin on different of but off. recommendation patients. shown milligrams

very we're AASLD and as EASL happy the to in statins use advocate, the of So population. those did

Unknown Speaker

Great. Thanks.

Operator

is Our and of question Company. Cowen from Ritu next Baral

line is open. now Your

Irina Margine

taking there whether is you on just My This for then wondering guys. enrollment relates more. Thank Irina program, line in Hi, are how the Ritu. far, dropouts, cirrhotic for going with one NASH your my question. one first to so is and And expectations. have I

Mark Pruzanski

Yeah.

we specific around early but plan. the progress. right fully guidance sites in We definitely making anything don't but REVERSE it with haven't dropouts, little seen per it enrolling, respect expanding untoward study expect It's we're the study. enroll too to to world, to and when on any readout, comment provide is we more trial, the now our we're to Phase referring you're X So a

Irina Margine

wondering Ocaliva been Thank you inventory that in have Great. then there policies just launch And back has you. Thank change to going any you. in the PBC?

Mark Pruzanski

Can you talking little inventory? on more about inventory? that? Are you Trade bit internal clarify a

Irina Margine

at hub. inventory internal your Yes,

Mark Pruzanski

at the there. to our remains inventory of support No. the changes no continued product, I hub so growth mean, stable No. the

Irina Margine

Great. Thank you.

Operator

Seedhouse is Steven next Our Raymond question James. with from

Your line open. now is

Steven Seedhouse

questions. my taking for Thanks Hi.

from think of between stressed might is a do more I'm if of benefit trial, how directionally endpoints I'm standpoint. you predictable? REGENERATE differently, not. just said trying perhaps, fibrosis resolution clinical of allocated to a NASH or the the the on it's just importance Just variable curious, though, evenly and sense two less those two allocated endpoints, or get have which you alpha you fibrosis or improvement

Mark Pruzanski

with our going the not analysis is hit we're to agreed these we're can that that that on can X succeed program we both the have we statistical FDA details you Well, if reading as advantage get other. out is call. of What Phase plan of I this the you or we've And on the benefit, the endpoints, one into is only the tell study know. that

which you of placebo, pretty FLINT the number see you a much refer in Of powering than resolution means because way robust very based importance with course, on Perhaps that's NASH still the is both features. both placebo, simply improvement essentially the highlighting disappearance, that study. on speak these endpoints stage to allow, long-term from by to hit fibrosis your than that means, from variability looking having both of underlying readout surprising a is the response question of I which you of any more one studies can't has can we're resolution. to know, appears frankly standpoint specifically what absolute Whereas I and an consistent pattern of answer in NASH of at But allow and study any see not can disappearance placebo critical it what on response we only the to variability. fibrosis. I that can hoping about is can fibrosis, large, be can't more in terms – on – shown a the

Steven Seedhouse

core also, time the where Thanks. increase prescribers and quite that this quarter-over-quarter or first first And of year in on growth quarter? this a are you Doctor far to you physicians so letter on versus return seeing And quantify to group last you the prescribers. year-over-year you just basis? mentioned yet? the now also so maybe you were just back Could Thanks. time in driving Okay. time time quick are increase prior prescribers Dear And and first not to continued PBC,

Richard Kim

repeat numbers. first are thanks, last prescribers there that the is that we this time the We earlier trend a first of I yeah. in were But earlier We of because the the year hey, in of launched. no, Sure, than prescribers now had lot phase year say quarter year. first can in a quarter exact what actually (XX:XX:XX) more and prescribers time changed second has really

for these of So in focus continued that's the half onboard a of to of us second clearly folks area year. the more get

Steven Seedhouse

you. Thank

Operator

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

open. is line Your now

Aspen Mori

taking Hi, our guys. Ying. It's on for Aspen questions. for Thanks

the PBC the of Europe? you by Provider in primarily benefit? Dear any any or have in And ones. received on quick couple feedback driven that sales, growth a Healthcare pricing volume was Just was sort the The any beyond there And then I out sequential maybe lastly a could letter you for endpoints Thanks. schedule give with – you endpoints, timeline PSC meeting for the FDA additional that have mean what you'll for (XX:XX:XX)? need working the do us alpha

Sandip S. Kapadia

Hi, Sandip here.

question of we any and in didn't first part, Just volume the last versus half on of have even pricing year, price, your the the changes. terms in

it driven by volume. So all was

Mark Pruzanski

in you could if Lisa, the And, question. take DHCP Europe

Lisa Bright

Thank Yes. you.

we've the of around the Healthcare remember, hepatic-impaired before patients for probably communicating issued. in been as some dosing Dear importance letter So correct you'll time was Provider

quarter-on-quarter seeing. I to strong So seen it reinforcement the back for fact the of seen growth what year and guess And we've you I'd a prescribers has that as communication been we'd number already doubled. is really since acted year that we've December the do that refer that this last the

forward. growth the going we're So about optimistic

Mark Pruzanski

we any is PSC, the but be by the on, have of with end agency, end continue to an on regulatory I are schedule said everything Thanks. year update FDA specifically with year. they going meeting our We we're don't And overwhelmed to able of how to before this the update to that's be dealing given respect guide that's delays, that division then you. comment with led PSC, we'll that PBC, to certain confident but just that bandwidth NASH, able that and constrained review provide we'll by

Aspen Mori

Thanks.

Operator

Citi. question with Our next is Beatty Joel from

open. now is line Your

Joel L. Beatty

the Thanks Hi. taking for question.

interim analysis OCA using peers reading discuss of NASH? with our the first and in of benefit out for you the are half the conversations endpoints year, important for – arguing REGENERATE the most next which Regarding in could

Mark Pruzanski

fibrosis. more on as to this of for showing continue not death, outcomes on and to mentioned is fibrosis stress that just call, we Look, believe evidence continue transplant, importance I've There's need much fibrosis certainly very mortality that's and liver to why clear to all-cause important. progression liver-related Yes. very a failure, benefit linking we the

Richard Kim

just important Richard. NASH add has to – as would to I would Mark addition obviously I – condition. it's just said, the is Mark, fibrosis And in and

actually compounds think endpoints can our base. meaningful are I both that going customer to So be achieve broader to

Joel L. Beatty

completely least Or NASH until resolution be fibrosis the that held is any to analysis? at preliminarily, interim Okay. like of to data there way the analysis and type And final link, will outcomes? any from

Mark Pruzanski

ongoing wouldn't NASH outcomes you all designed so I of over years, X this the are – of outcomes a the REGENERATE five to in Phase but population. of typically and I programs needed know, current as sufficient or on mean time as period trials, just number given accumulate

them would I interim, in outcomes that. expect sense have not the – will I So, and monitor going but the wouldn't of we're study to expect obviously

Joel L. Beatty

Thank it. Got you.

Operator

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

Your line is open. now

Joseph Stringer

are my Hi, And on other example Intercept's Joey biliary for therapies, question indications of – about about you OCA for first a you the this as quick OCA a follow-up sort Thanks that? here, update the Two potentially an – high that, therapy? combination the give on for looks level, is, still is the, trial? And thinking as like atresia rare liver can Thanks. just to disease using second for a ongoing one, thinking it's backbone on ones question. taking Alan. what's

Mark Pruzanski

for Thanks Yeah. question. the

So we about but very have a atresia, liver we right pip enroll pediatric this our biliary continue rare study. and disorder. chance now cholestatic to is is a never It to talk

are quite include you appropriate imagine, how there As time. patients takes the are few given especially, who study in some clinical can to it

the enrollment So enrollment, we're committed the of around not rate efforts our on but we commenting remain to and continue study world.

that we of non-viral at only so also see and even we think lot a that out liver backbone. OCA. on much to are much part is end and the combo – your a feel diseases to context with for more much that with actively that pursue. the to safety. focus NASH believe, combine which Oh! just confident liver the getting not community early remaining in there regimens indications. take need continue liver committed it's lot second than days then liver on of Yes, cholestatic in We not that there's looking of have of data in and but whether proof-of-concept to blockbuster OCA evaluate other absolutely, out that hope do disease, and as it's up very options patients here fact And longer with typically often diseases who of see with opportunities perhaps established it's PBC, the prayer was very no progressive if people rarer said, we a diseases And other proposed broader going than combo transplant there, to means true one, and the a to to the on eventually market, untreated question mechanisms We real are other the NASH or despite We remain to PSC. NASH,

Joseph Stringer

you. Thank right. All

Operator

next question with Our from Joseph Leerink Schwartz Partners. is

Your line now is open.

Dae Gon Ha

Thanks for Dae for taking This my is in morning, dialing guys. Gon Good Joe. question.

we're patient So ones REGENERATE potential wondering, in guess forward the of the and the hitting the I you more both improvement we look of of this into least if but amenable the I this biological talked most the co-primary or internal a hypothetical looking fibrosis what on NASH to for approach, improvement kind doable? the NASH you data, what think to market side? just alluded kind your hitting question, I of so been given it's mean resolution equation little in you of that work significance side, at a sense level, kind versus based there least the start least statistical to only NASH dig then have endpoint, trends one Thanks. interim the What as And I was out at has – into more done but would one? physician quick wanted that's safety makes mechanism your prior on be impact you and me. earlier, only addressing uptake a is of side briefly evolution, two at do guess hearing what think analysis, payer the on on And about would into on about half research, efficacy a the combinatory question fibrosis on had question statistical poly-pharmacy just going proposed that second thus you terms to that alluded market deeper significance. far,

Mark Pruzanski

your answer to the Richard then ask part of question first the I'll take and second.

Richard Kim

like of lot that that – lot mean characterize hits of I that patients a are conditions not know guess can what we're I and the is a I extensive We cardiovascular and but we about – as research to comorbid comment physicians disease. both diabetes in patients are are patients are of into offices, really the have Well, a who them, sort going the of other, sort conditions treating these say done have or NASH when marketplace far primary poly as really the to facing.

that. to we well So have really characterize

rest So these what of early what here. a I I knowledge say the to quite do think are it's our know, patients think can how Mark, payout. to But bit say base a of will you I knowledge too in up little of built about exactly take I don't we've want through, really a this lot sort the then? going question

Mark Pruzanski

Yeah, sure.

little and a So detail. about maybe I combo bit more think you're asking

been hypothesis well, this most that obviously but as definitive at the in non-invasive even without question, promising just the most early classic reading RI so are in nothing that that and other the doing said look, on biopsy-based the endpoints past call, obviously, histologic, I or of to shown well-controlled population, the the there the still other predictive. mechanisms been, because There previous think actually publicly interesting. on a far proof-of-concept just else it's at-risk to some with point we an X, looks mentioned I've days. again, studies data. X. that. critical most, has molecule previously that I are having be stage mentioned given validated That And on As there we've an importance answer has – at are already out out approvable got But this in target's FLINT at Phase in and point a

Dae Gon Ha

if you've I I that with market more. you you the new trends the been If on evolving? these pipeline, any NASH seen clinical particular I trial all there? in squeeze mean, can one just are in seeing has guess drugs Thanks. way? And can comment the into NASH segmenting a market coming how

Mark Pruzanski

NASH out lifestyle Well, only answer because can thing for and is that country approved The and diet coming counseling – other is at is and more support critical, and floor, there in patients. while top they But the these there with in – lose do into that hepatology provide and it is first and day, the my obese. of hearing out was is lean right? get also most couch deluged the just NASH that no nutritionist try same for and the their right is to clinics. market their improve product there's centers off simple a counseling, no patients where I now foremost is these obviously right, do, aren't visiting marketed weight they're these obesity we is one also patients to All the patients can we're there's that the what time their

we therapies. see And then, physicians really talk segment. these are But awaiting so, market look, out patients, this and a lot is of in how epidemic proportions, approved to it's who about heps gastros there, and can't until going eagerly the

Dae Gon Ha

question. very taking Great. our much for Thanks

Operator

Securities. is with question from Wells Jim next Birchenough Our Fargo

open. now is line Your

Yanan Zhu

for Jim. Hi, is in This me. for questions. Yanan the for ones taking you quick Two thank

of outreach PBC second XXXX. segment half you physicians you increased the to effort, to have from community in launch your GI and in expect So contribution mentioned this emerge

is NASH Just are And have placebo-controlled of FLINT. by treated readout community program. trials to physicians? curious what related number question of GI proportion A PBC second patients since the

consistent Thank wondering there your their at you. powering that arms just study? FLINT NASH fibrosis their when the the for look I'm So is consistent assumptions assumption with rates learned with resolution? and into Are be the anything and and placebo link REGENERATE to you at look improvement

Mark Pruzanski

to and Yeah, Richard part of second. I'll take thanks. the question the the take first I'll ask

Richard Kim

Great Thanks. question. no. Yeah,

and XX,XXX to patients XX,XXX hepatologists the States, where gastroenterologists. as that the United around far in about are, XXX in now only are mind probably dubbed there's keep as So there's physicians

we So obviously, reside quite community. the are of the spread the patients PBC And as vast phenomenon where before, thin. gastroenterology majority PBC patients said a is in

They'll percentage. more say don't at around generally a many community the quite the a is our are of have large but the or that give patients. we three numbers well. so. out these have a that of exactly, as or many what exact for how to of community, back there's hard would probably you you to these important But maybe just the question. an reach GIs have in So That's And or only few there is, percentage a only based, of time, is patients. Mark, physicians there because physicians a three two there's couple manage of lot those two why large patients NASH happens

Mark Pruzanski

Yeah.

controlled response one been studies. specifically Anything that. what And the in Yeah. a has improvement on respect in lower has got and Phase significantly This placebo placebo conjecture has consistently So call. remarkably biopsy. the I've One it placebo rates, get in been you're response stage, learned to from now that's asking about improves. consistent around into I going placebo to with There and fibrosis been not response five from hypotheses, again resolution and pattern observed I'm importance on perhaps on the earlier with X response. alluded the NASH XX%. we've about stage to studies what my to patients surprisingly. not placebo large, doing respect nine of drives observed. but at longer-term consistent by this right basically with critical months own highlights

what and features think haven't across our we But see powering respect you of key which anything because question, looking with that in and mentioned, responses. again, single-digit typically to assumptions. of here our fairly your taken you're I disappearance counters seen we've consistent I away As was for the But, thinking studies. REGENERATE, about disease

Yanan Zhu

Great. questions. Thank the for taking you

Operator

I now any back I'm to the Pruzanski questions. further call no Mark showing for further to would like turn remarks.

Mark Pruzanski

everyone, Well Yeah. for thanks, in listening today.

focused first Phase worldwide the non-viral to of on PBC of half of disease. that whatever steadfastly are our in business XXXX, And to progressive which year. patients We the back up readout need. NASH very liver our gets key in to lead the and PBC to in their delivering is well-being Intercept drive objectives, disease, at committed remain program the Everyone REGENERATE and For here global the course execution Ocaliva be excited. we our ensure to in patients continue and health to very X with continuing next half of on

Operator

Ladies and for participating in conference. gentlemen, you today's thank

a You have may disconnect. Everyone, day. now great

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