ICPT - Earnings call transcript Q2 2019 | Intercept Pharmaceuticals, Inc.

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Operator

Good morning ladies and gentlemen, and thank you for joining the Intercept Pharmaceuticals' Second Quarter 2019 Financial Results Conference Call. All participants are now in a 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 a webcast of this call will be archived on the Company's website for approximately two weeks.

I would now like to introduce Justine O'Malley, Vice President, Corporate Affairs. ahead. go Please

Justine O'Malley

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

will profile, potential our for of regarding we our launch the, and filings, development making we strategy, approved our our begin target product product note timing commercial OCA regulatory during success statements, commercial including prospects, programs, acceptance future our I'd products discussion, Before NASH certain approval, and to forward-looking of financial like that call be statements potential including and the and our performance. and financial candidates guidance and clinical

undue speak statements, place by of as these Listeners law. obligation the undertake date except not reliance only call of update are which and we to required this no to forward-looking as statements on such cautioned

believe These forward-looking reasonable based and uncertain on are and estimates statements that are subject a risks number to inherently uncertainties. of be and to although assumptions

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

Chief those will up Sandip with Officer, call by Operating your we our questions. from CEO, open and Financial followed prepared then begin Pruzanski, Chief our call, Jerry Dr. take Today's remarks from Kapadia. Mark our to the Officer, We'll Durso

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

Mark Pruzanski

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

revenue we demand press strong our a our quarter in PBC in announced business. in the team second had delivering we this with release morning, substantial growth As

program. NASH also while next year, bolstering to Phase great planned our launch make progress further continued our X for industry-leading development preparing We’ve

while with approximately remaining great the two study target outcomes enrollment complete of on exceeded enrolled study, of momentum this patients enrollment between we track announced expanded we’ve portion to-date Based year the X,XXX on the the in REGENERATE to the seen, REVERSE that we studies. later

In strengthening that netted support greatly sheet. more successful of the our proceeds than a company little million balance executed $XXX in we these a financing activities,

results really our to quarter note PBC prior business, outstanding I million respect net continued With in sales resulting the commercial worldwide team’s growth to XX% the in second pleased representing in am year’s our execution Ocaliva versus quarter. second $XX.X

positive PBC prescribing growing community feedback Coinciding and with patients receiving their a of we’ve from the seeing Ocaliva group to its and this been have who performance hepatologists benefits. is been gastroenterologists,

excellent an markets developed our We’ve understanding disease internationally. Ocaliva of we the and in are target our specialists while expertise marketing honing where approved U.S. liver these continually commercial other

positions we core again very base gastroenterologists. hepatologists us our successful and well first-to-market of where target NASH This will in specialty for launch a customer

to NASH made pre-launch over effort, Turning on are progress our well quarter of now number these the fronts. great underway with a

MAA the Our to team on filing working the later our in remain followed quarter filings for and we quarter. this regulatory NDA prepare EU has fourth FDA to coming in track submit to months the the in by our been

time, the our with the In productive we NASH in and OCA These key groups. payers continue launch connection preparations importance with advantage and stakeholders will interactions over have to OCA. physicians, NASH, critical very become an we therapy patient essential of patients of benefit the within in what competitive recognize anti-fibrotic therapy first If we be to advanced fibrosis. with approved, a key underscoring believe expect

prior our specialty We and a is this an launch for investor plans NASH that commercial commercialization launch us will we and believe to that foundation. presenting forward event at a blockbuster our firmly opportunity strong approval. leverages to driving by be realize able look that successful We to

we preparations, of to the launch program. most kind. In continue outcomes Phase we’ve the addition target the I that REGENERATE our cohort pleased ongoing industry-leading by study It’s far patients its advance study completed and announce advanced Today, largest X enrollment of to development NASH more XXXX our than randomized. of am NASH to with

drug OCA X To-date, the have an and to adequate a benefit remains in shown anti-fibrotic well-controlled only investigational NASH large Phase unequivocal study.

a we on what OCA this and study. to respect clinical analysis REGENERATE in as outcomes to have Given believe fibrosis portion post-marketing positioned confirm in the that interim observed XX the benefit go well reversal we therapeutic to is with month on of basis stabilization,

important liver expect contributions meetings fibrosis November. to include clinical to non-invasive also at AASLD that scientific abstracts, of and on study provide OCA’s the measures primary Liver as We the upcoming publish Meeting outcomes examining REGENERATE new patient-reported providers. anticipated insights important additional healthcare such will data present in new and from results effects Important

compensated Today, cirrhosis. we of success ongoing study the also made drive stronger announced to with patients our of recent NASH X changes even in confidence OCA in we’ve Phase REVERSE

with reminder, in worsening of identical improvement is OCA REVERSE endpoint REGENERATE. a no the in endpoint the achieved primary fibrosis As to NASH

in confirmation we’ve with the sites investigator effect REVERSE only and patients, enthusiasm at patient XXX and of seen enrollment in X study. close study tremendous now the With worldwide in earlier to ongoing REGENERATE our anti-fibrotic the OCA’s strong cirrhotic the active Phase continued and this of momentum year,

approximately we’ve XXX to patients. expand momentum, to this on Capitalizing decided REVERSE

by completion Importantly, we guidance are enrollment of year our end. of maintaining

We study order phase are double-blind XX with of months align this to from to XX extending the REGENERATE. in also

the to our approved failure we being by this are readout liver more very of of support high cirrhosis. with the recently of for As the of uniquely of population. as a at leader NASH compensated extension indication segment OCA particularly Such FDA, advanced NASH the the patients patient positioned to we in the and high risk need treatment of successful unmet expect represent an pursuit patients reaffirmed REVERSE

strong the team of what’s in business effort our our half planned an in To been we XXXX, initiated our first PBC for and summarize, continued momentum first-to-market incredible preparing

year. next launch NASH

to NASH launch. we our are resources have building, team market deliver preparation in on successful the and confident We the a activities are hand we

In contemplate of ahead to the due continue disease. our us filings, at patients this of it’s to prepare help inspiring as fibrosis opportunity all upcoming regulatory the to for we with Intercept devastating advanced us here near-term, to

With for activities. on that, a it now business prelaunch update PBC Jerry? Jerry more and detailed our global our turn I’ll to over commercial

Jerry Durso

morning, good two everyone. and with representing growth second strongest worldwide We Mark, was year. the reported in last Ocaliva million over our our Thanks, performance. quarter Quarter o XX% commercial quarter t net sales to-date $XX.X regard

to achieved we prescriber PBC of of commercial business. in and net execution our base reach physician million and our with are significant our doing has In we’ve work successful. PBC our $XX.X the expansion U.S., which The drove of team’s pleased sales been strategies expand been

January, from In fact, patient about since new enrollments one-third are prescribers. of coming our new

Ocaliva. In product. clinical most research, receive continue experience of market hepatologists We recent our quantitative Ocaliva the prescribers from reported positive to with the a approximately prescribing our experienced of gastroenterologists and positive XX% feedback most were

Ocaliva Turning are the to XX% in that indicator international becoming in growth using and the the compared the second net representing quarter of sales well to we million PBC patients. their clear believe is achieved increase We ex-U.S. region, more of XXXX. of is we physicians approximately seeing $XX.X team quarter as confident our executing a the an second are ex-U.S.

of confident of the PBC remainder ahead to the business. look in am I commercial to capabilities XXXX, we team in drive our As our momentum

in our preparations launch NASH, U.S. been quarter rapidly the ahead we’ve filings in later to progressing EU and Mark as turning the expected fourth Now of mentioned, quarter. this the

first be While today U.S. our as preparations making is progress in abroad, to are to the going great and on expected we domestically NASH. launch market focus am I our U.S. to

to work inform and imagine, amount our work our you landscape strategies to the As planning. extensive NASH we been quantitative payers physicians, might conducting and have a launch of have and understand market research undertaken and qualitative patients evolving significant with

to patients already is One number that the available. with education being of this while required due there also today develop there that identified evident the is even market, advanced ahead fibrosis setting substantial are the to in of therapeutic points is specialty NASH of

done due as at the with cirrhosis market patients for that have are cirrhosis. focused these patients indicates highest a that treatment NASH of on advanced It’s with as are on preventing goal. physicians need we top remain greatest progressing physicians the the of based our work fibrosis who to clear the progression is treatment risk those with research, The

hepatologists attribute in efficacy in with quantitative over very advanced over these fact, research a important as with fibrosis NASH treatment patients survey, XXX gastroenterologists, specialists and of rated a In the most halting XX% it the important. to due deeming fibrosis

benefit confidence and OCA approved deliver in our stabilizing reinforces and insight the first With commercialize OCA that this our ability of the the physician to and reversing fibrosis, successfully progression NASH. potentially to positioned be therapy

to likely of practice. same research, after prescribe approximately indicated in the OCA’s product were they profile, a in quarters or product fact, blinded definitely very In target the specialists such their three viewing

cirrhosis. with be early We more the risk advanced fibrosis, progression patients believe will given that to greater adoption among higher of

of to indicated For patients poll two-thirds example, FX the to need urgent. was close very treat that specialists their

moving is by in fibrosis. is from the Although transition score paradigm market away our certain research market a on traditional towards we fibrosis defined the or advanced framework, based framework instead believe of F this early data and and

non-invasive driven is growing It acceptance change by is that the tests. being this of view our

use measurements including NASH and physicians non-invasive As tests these of patients we’ve do grow a fibrosis stated to and have to are of previously, expect under identifying not majority or generally treat tests patients widespread with community and the biopsy the advanced we acceptance. modalities as care had continue blood-based using gain imaging

of our anti-fibrotic market therapy clear care market. with in of once fibrosis is patients that under and and the insights specialists like number there patients OCA today confirm significant treat a the In approved an available willingness those to advanced summary, with

payer states, note conversation educate good on our our fibrosis launch at identify depend with payers monitor these to and results our made best will way payers. also the to to-date that progress precise on continue target patients. NASH of to the It’s importance important the as population to on disease Moving we and advanced we of the treating interactions,

have the with Based need. they prevention they of advanced generally cirrhosis value similar and on physicians, unmet a fibrosis greatest indicated have the and related what view our with to that heard that payers key driver as we’ve complications patients agree and research market

recognize evolution of patient payers away from with considering fibrosis. the align of the moving we diagnose payers towards patients will current practice physician that to believe also our greater identification, that support appropriate When non-invasive sentiment advanced experience medical tend with use with the methods is biopsy, and use to

launch, a proposition as demonstrated OCA’s patient believe towards population, with access finalizing regarding working we progress and target ensuring fibrosis together and that We benefit have we our value we payers will be strong pricing. with

the target at While specialty NASH, of a patient’s we are understanding be launch launch in critical. the also planning for real perspectives will

close that that including they patients to two-thirds target very prescription one. they market already XX% very of stated care a recent that a additional a research with concerned Results conducted the NASH survey over patients under would we’ve profile about show these they of of for Accordingly, stated specialist. and receive fill a if a about are to OCA’s be likely hundred drug

confident patients advanced fibrosis reinforces feel research successfully the offers if to due in and NASH. first our our we OCA positioned are belief benefit across and bring Overall, therapy launch well to that to market payers the approved we fibrosis with physicians, and OCA that patients

Mark mentioned we market sharing more as earlier, As to forward look the close launch. get we to insights in-depth

From have our anticipation NASH. for in accelerating of an plans we the we of as are readiness approval momentum perspective, operational OCA great launch

to for to gastroenterologists As preparing on are we the focused States. approximately NASH a XX,XXX target launch due fibrosis hepatologists with and United in previously patients specialty we plan advanced and mentioned,

we functions the X,XXX while launch, support at plans about to physicians to of teams our initiated have home and ensure serve our business. to Today these cover office bolstering field-base for our effectively coverage PBC, increase

affairs For of already our the expansion example, we’ve completed medical team.

actively payers. We have teams are and access engaging strengthened our with

gated We of and in sales launch the we’ll in with we our additional out closer force are stage leadership accordance manner in sales our OCA to plans for potential as the hiring build organization a approval move NASH.

launch the we closer at plans medical and feel and as expanded work move education to with our specialists confident I to NASH of affairs ability in OCA the hard educating to execute rollout in our approval our continue disease connection NASH. already of campaign. team expected Our is

about our excited launch We to the driving the we skills are prospect successful the NASH the are first-to-market strong people, build accomplish we and of to capabilities have believe and poised on our goals. business PBC in where the

financial will And call Chief Officer, for over Sandip update. our a to the now turn I Financial Sandip? Kapadia

Sandip Kapadia

Thank XXXX. to you, the earlier financial morning press good everyone. our full summary and XX, June for release today issued Jerry Please quarter ended of a results refer our for

net in for in proceeds We quarter $XXX.X approximately important raised an was QX successfully us. our million financing transaction.

for versus in investments saw our well very filing, made PBC strengthen program, strong prepare as prior launch as clinical NASH quarter business, also the development volume our activities. to important We growth fund year our and our

recognized revenues, a In of growth total million million the quarter of in XXXX, second $XX.X the $XX.X quarter, versus the quarter. XX% we second up in prior from year

sales million $XX.X comprised Our were U.S. and million. $XX.X sales of ex-U.S. sales of net Ocaliva net quarter second of net

did though go outpacing trends We quarter. forward. generally continue to normalize growth orders to prescription demand in expect a was we have we pharmacy specialty during expectations, but our would we as the with strong This line in U.S. fair the that

Total range. were to of our quarter towards previously net the XX% XX% gross for lower-end to the communicated

expenses the $XXX $XXX operating million. GAAP were quarter expenses for Our adjusted non-GAAP and operating were million

amortization. a our As operating non-GAAP exclude expenses and adjusted depreciation compensation, reminder, stock-based

with was the year quarter. second were sales $X.X and consistent million, of prior cost Our quarter for

the expenses the quarter our million prior $XX.X primarily million. quarter Our selling, related and driven an of general over and were activities. preparation year by to This NASH administrative was launch $X.X for increases was increase

research for our Our expenses submission. was by were development with program primarily associated the the development million. NDA our the The NASH and of and This $XX.X over quarter. preparation an of driven million was year increase $XX.X prior increase quarter cost NASH second

As $XXX.X had in and million. of cash, June debt approximately securities cash XX, of for available XXXX, sale equivalents, we investments

XXXX. As this concurrent May of our mentioned includes net private and convertible common of the in placement our proceeds stock million public previously, offering, notes of issuance in $XXX.X from

build we our business, in PBC a Moving support to resources and to our efforts be as filing XXXX continues year regulatory while NASH deploying launch momentum our to activities. critical financial guidance.

in outlook to and continue be XXXX. the Ocaliva for confident We the for demand remainder financial the of

to expect and the specialty do we by effects QX. in QX pharmacy see orders of earlier, mentioned stronger normalization As followed seasonal

net between a reiterating announced Ocaliva million. million XXXX we to our $XXX result, guidance are of previously As $XXX sales

now the performance, to strong of be range. the we expect this in Given upper-end

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

we addition, $XXX expense operating XXXX to are million adjusted reiterating In between non-GAAP our $XXX range million.

strong have regulatory progress a clinical important very making to the In good in are investment are PBC a cash summary, fund advancing our decisions solid NASH and our in program we filing, position, business launch. successful strengthen and making development and momentum

to Finally, reconciliation of financial this our adjusted as explanation expenses non-GAAP release under operating issued earlier is Please a press for reminder, non-GAAP morning measure measure. a regulations. an and SEC refer this

Operator? over now to the like the I'd to for questions. turn call operator

Operator

Our Please Instructions] comes ahead. from first line the [Operator Yee of Michael question from go Jefferies.

Michael Yee

REGENERATE Hey guys. Congrats REVERSE sounds on a strong quarter and the studies, progress on and your great. that

- a about to I that that how and I think questions, guess, pull launch. two the are year questions closer, think community’s will you both I two we have while PBC color a appreciating, launch one, launch as guys NASH versus get dynamics to next investment have on more the are, the push, related of my about thinking NASH

things are of different from has biopsy confirmations, dynamics but in example, one nature be Obviously, that differences more PBC. significantly any would patients, for there that

versus NDAs to NASH And that, have of then, that to just you’ve about maybe have a NDC you expect differences So codes. said PBC. is, and question launch my the related other two two filed already different different comment

Maybe being on that good whether okay able that do your just Thanks comment about pricing? whether indicating you much. confidence payers so with and feel to are and about

Mark Pruzanski

them. for to your Jerry questions. I’ll take Mike, thanks ask

Jerry Durso

been I that, first on going guess, NASH we opportunity we questions. to identified identified are the of recognized as unlock these with and number are already the the for Thanks that going most that with said of are Mike. there of blockbuster we a target and launch that through here are that clearly specialists have course one, we specialist biopsy. without today believe significant Yes, the to patients we a to start are have sitting

would that chronic see physicians probably or would will rhythm on condition where that the would you would in and – key we NASH NASH patients launch follow that treatment expect one would. between think the this the of with rhythm differences I and typically their NASH would that the we with see anticipate PBC medication be chronic a the we to what resonate regular

that’s of are pretty a the is number So the main physicians. across very in They group where of low clearly one very diffused patients to have tend difference treatment PBC a large patients be gastrologists for the and group individual hepatologists general population. would case the will in normal which physicians in have of where necessarily larger a patients NASH NASH frankly of their

Michael Yee

that the been lot more a your have base Would could that comment then And have like required? be to Is that biopsy, would that be you timeframe certain or PBC? within a about feel do it case?

Jerry Durso

Yes.

Okay.

we’ve in do a learnings indicated to So, continued the see we the and in I’ll all these without as to that min patients from biopsy. we to a are market, order willingness a physician – doing take identify see try as we

see of lot towards moving the the utilization emerging marketplace some setting. also We of in of a momentum with the clinical data non-invasives much in more

We also early know align prefer that to that we with discussions the payers we’ve medical had payers – know the with from from practice.

to them So, appropriate work do way. we continuing see on an the in non-invasives movement support to

We payers you color the patient et exact some through the give to will also we we’ll that towards launch closer. population deep as more on we progress we are and be know that result get conversations cetera that the with as have going of

was And then, on I think Mike indications. your pricing two between different third question, potentially

a a successful if as differential the are pursuing are, strategy. fact give separate We This We NDA. we explore an to before, us brand. pricing filed securing would of dual-branding we said option in second

progress customers. both discussions final going and imagine, with our that with with and and through on based ultimately those is discussions process work future the some payers regulatory we you as our course, perspective of to on be But dialogue as would

Michael Yee

appreciate much. I so guys. Thanks it Okay.

Mark Pruzanski

Mike. Thanks,

Operator

you. Thank

Cantor Fitzgerald. ahead. Young go Our next from comes question Please from Alethia

Alethia Young

a two-and-a-half well question. on taking Congratulations you guys. progress cetera, here. et Two, you’ve for that cetera. Thanks good for quarter, Hey and very two, my et finding the made questions as maybe, patients

talk from to that bit the FDA? was the impetus and the wanted little something the potential Or behind it trial, REVERSE. getting something along just I a in population What was change One, about the it internal? was

your kind significant on you patients kind it’s began next work, else that, found ask a mentioned I’ll just then, can just of you’ve for Or as will was while quantify for drove exercise? my us that that? identification is, say with the you’ve maybe, and let’s a estimate, And number of you question it the anything blank, going whether how year clarify those ago not, same you or low today? high If or Thanks. this of you patient

Mark Pruzanski

Hey, Alethia, the I’ll take first question.

opportunity to that respect with some drove lead REVERSE, out for we floor we for saying been particularly time been completely need of a failure in we’ve since alone huge a completely now seller this that there us. and looking and the this. I’ve and are the really So, unmet is

ways we’ve completion So, our the are what we play this the looking maintain seen of worldwide brainer that precisely to really and enthusiasm enrollment study we’ve for on can this us. for no year great done guidance made momentum we that’s the of study. enrollment end a and decision go for fact on And capitalizing by

end study. largest So, be in this ever NASH will, resist the the

I got with REGENERATE mean, enrolled approximately now the target Xs, outcomes we’ve far signal I prepared lead portion enrollment fully As reach. mentioned my well program remarks, that and cohort are X,XXX into between we our are patients just two of development how Phase the in in we in to the

So, about with both we our studies. good feel prospects really

Jerry Durso

definitely that, specifically the a deep something XX, Alethia, the to question. XX, into covering over months, think Yes, as would has are That second today. time. would future XX past be of a might Yes, would we not populations I forward say at progressed it be take we going patient we look to go I exercise. I’ll your part the been

a one map to not that of first we this clear have the area existed. is company It’s in really that opportunities there as deep exactly the go

quantitatively us deep really to work this to go work was primary up So do in and to finding. the

more have And confident months, past, forward towards and XX at that of again, we’ve we become point. opportunities later say look in over XX the range that that would sharing we I the a would again, or

Alethia Young

Great. Thanks.

Operator

you. Thank

comes question next go Our Please from ahead. Abrahams Brian RBC. from

Brian Abrahams

patients the and in translation questions Two Hi. with diagnostic of respect taking Thanks for are all from on guys congrats to the screened questions Where of and data quarter me. REGENERATE? analysis you my progress. from

of this And this that at Is for elucidating initial we for we part be part could about the diagnostic should non-invasive label of looking initiatives thinking be broader something or be potential? ASLD? should more as

then, PBC, change? underlying demand-based that sales could maybe U.S. orders drove quantify separately and what’s Thanks. quarter-over-quarter pharmacy to you between actual specialty was And uptick? extent this difference sales quarter’s demand the what the And on

Mark Pruzanski

Thanks Brian.

we advanced mentioned So, data in and OCA to to on the serologic presenting on both REGENERATE question, identify first are made from we there your being earlier with dive non-invasives on and prepared various a and on with already yes, respect the forward what in we used patients are looking other non-invasives deep as out my effects to believe doing we are data REGENERATE the know now remarks, point I imaging that fibrosis. to Jerry

With will at have So, question, treasure to present a having additional here. upcoming I look the I’ll opportunity hand said REGENERATE respect second including have the ASLD. meetings to data is we there the Sandip. –data scientific to often from forward

Sandip Kapadia

mean, Thanks. have the very very question. had pleased for and strong we strong quarter are ex-U.S. Brian. demand. the we U.S. with both Hi, Thanks I momentum mean, obviously, a and we very Yes. underlying I the in

I have especially sort about ours out IMS the I think of we data to there. the way think impact mean,

of be can it indicator continues with underlying our good a and So, this to demand the in we certainly in – U.S. was expectations. line still

typically. normalize of sort to this expect We

some obviously seasonal QX. effects in also had We

expect very But we QX. strong a certainly

reiterate range. this upper-end some guidance to the be matter Hopefully our of expect as gives of We at to that and a at fact, we background. our continue point you

Brian Abrahams

Mark. thanks, Sandip and Thanks,

Operator

you. Thank

ahead. Our next Please question Capital comes from Rahimi Yasmeen go from Partners. Roth

Yasmeen Rahimi

Jerry. both are and Two the for for continued to you questions progress you directed Thank updates. Thanks. the

on authorization? pricing? of us as color a NASH do request have range of is to payers prior of believe by the going NASH a price give what a little you kind Specifically, So, probably bit the that’s to sort minimize you can biopsy

you us then, NASH FX healthcare And patient about on is of burden the you. patient? can current system Thank maybe what’s versus also cost an educate the FX NASH

Jerry Durso

Okay.

about a it’s to NASH are about clear different maybe thinking But on populations. Obviously, color diseases, price. are premature the pricing talk that So, little PBC different specific how very and we points. it’s NASH

discussions All of payers are the top and indicates insight are we the they goal. that with that having

REGENERATE proposition. our be way been is fibrosis the think fibrosis we importance value The saw that to With able kind that about of of progression NASH, they data the in the cirrhosis and REGENERATE conversation. the be around the that them value and benefit and that in them will to of core the concern important to from and the generate we’ve end-points at will

metabolic that we the to are believe a and clearly a drug And will and providing classes launch. the other of going also are other more be from some benefit course, focusing benefit, specialty launch in fibrosis drugs value as that strong give we effect us differentiation the

this We engaged can not specifics are topic per to and more communicate on look go as to se. the fully FX we’ll into imagine you

cirrhosis. is. ultimately closer with as But where the are comes patients the and recognize patients to The progress FX the cost payers get that it’s the concern burden clear complication

is early and cirrhosis So, around of over cause although, patients and advanced again, fibrosis and progression fibrosis advance the moving of market time see an a the classic factor. that more away concern kind from as stage we ‘ the towards framework

from again, And appropriate topics, payers. to discussion that prioritization, risk these it’s access mind we of good real and of is a productive it’s are our the continue to at all advanced we those have are of identification around why right to price, that drug their the learn who top their that a fibrosis intention we where high and urgency on with believe patients the get impacts shared to payers patients patients ones will

Yasmeen Rahimi

the And Is internally then, something upcoming we of that is you that evil data be plan expecting at the sharing done Boston? in see on you meeting terms do liver of should that work. to have the in PRO act? more when Or

Mark Pruzanski

have scientific think to at meetings. subsequent it’s important we present I Yes, and data – at will ASLD

stay tuned for that. So

it’s talked PRO think presented. I’ve we’ve specify I the data. about be going before premature to – to But what’s

based reported really on quality The experience being our of data patient the outcome important to validated life taking drug. as of highlight patient instruments

So, stay tuned for that.

Yasmeen Rahimi

my taking team Thank questions. you, for

Mark Pruzanski

Thanks, Yas.

Operator

you. Thank

go Our Skorney comes Baird. Please next from ahead. from question Brian

Brian Skorney

the more Hey, guys. on methods used Thanks are little morning on REGENERATE. that for non-invasive A of going be the seeing good taking data question. sort to we in

utilized? made Can potential changes interesting you fiber in REGENERATE patients Were just scan what were MRI think and you study? surrogates what liver non-invasive measures intervals were measurements and are most What analyze the in with the review for utilized histology? your all those in TDFS

Mark Pruzanski

Yes, sure, question. for Brian. Thanks the

use that are are point-of-care relatively inexpensive, So, non-invasives to currently physicians of the primary NITs, that already using. focus in terms relevant data easy are or what call we available

is sensitivity like our very and is to But for screens is easy fibrosis. on and enzymes with very this. liver first there the an patients with APRI four now that ALT, a advanced and platelets literature to specificity fair APRI calculate standard platelets starting So, like with of on are improving starting . amount AST AST, that’s identify good AH based scores

tests is FibroScan, like one. transient U.S. the ordered outs elastography fair There base in a is an can It’s a there U.S. cut and appropriate to fibrosis. that extensive literature be in base installed other of And advanced currently Europe. the amount obvious FibroSure. are the reimbursed, on in other with there patients growing identify approved, with installed point-of-care

all And we right? fibrosis be benefit. that's are launch important these all position for obvious are fibrosis, it us that are drug a focused on. saying a that, that why these critically primarily should of things So, be in note so we it’s I focused commercially with and want to to though to a on keep

a we’ve drug only but with getting not NASH so-called a that constantly been the associated is at I’ve The lift on higher that got approved it’s ends This much with already available grab where up non-invasives of point-of-care just bag saying employed. be outcomes, resolution. as the can

Brian Skorney

Great. Thanks, Mark.

Mark Pruzanski

Brian. Thanks,

Operator

Thank you.

Please question next Ritu ahead. Baral Cowen. comes from from Our go

Ritu Baral

with question. of on guys. for you changes, away bit, NASH? I the into comment NASH? taking stages. Maybe, of What definition guess, start Hi early what of the like Can cetera et little advanced F the constitutes how from a what, how diabetes, early we does will is and cofactors as And like from moving that? quantify that – NASH advanced and Thanks staging concept your sort clinical of constitutes high-risk the definition weigh

Mark Pruzanski

the moving really non-invasive Obviously, a Ritu. being Thanks, development X the being NASH and still programs reason are in Phase primary towards is X, because field NASH world. Yes. today only we I evolving, it’s patients is clinical mentioned. reason in patients required. And mean, as biopsied Jerry or frankly,

Jerry receiving just But world, education drive continuing on a the that of and or under is majority mentioned, real market care we to patients mentioned know critically are treat analysis biopsies. that’s based I not around our non-invasives in these research, as that And why so important.

advanced your patients We we’ll be away that that world versus where or with categorizing fibrosis stage to cirrhosis. from early one fibrosis, to do is think no versus the evolving question

scaring these you And the exact are definition – is fibrosis what underlying I can the liver. rooted in that, in tell

able over is to time, be we that diabetes. I like co-morbidity factors certainly, mentioned, identify you think, will like risk

clearly know where associated for that’s payers of what all and is alone stakeholders, for of and physicians, focus for ultimately risk is that, for But we patients. the fibrosis course, is with really outcomes the

Ritu Baral

defined validate to Cowen the organized diagnose/NASH a omit sub-analysis they least had exactly non-invasive pivotal with mentioned that did biopsy world then, could FDA the in in that a such moving to they meeting recently SEDAR and some the of implication it. sort a had at – we actually see label. was would, you love minds what the design, Got where prospectively And their non-invasives is within that

Can you have talk don’t you go prospectively will with specifics, you about whether into the are analyses to within REGENERATE defined that - discussing be sets but there FDA?

Mark Pruzanski

mean, non-invasives data of of deeply is I a we’ve And the in pre-specified certainly looking have that we FDA I as been few got. at Well, ago. I minutes mentioned that totality the the interested use various saying,

said development require have your would what they to that, here. They in clinical to move I they We box in know, themselves key FDA is program. another a ideally they – stakeholder mean, like point, beyond

for that’s So, data It’s a so with get sufficiently the to working to development to need they certainly are remove comfortable problem. But going very this validated still going being indicator to I to for in a programs. biopsy on us be non-invasive while lagging that take with think little them interested enough speak.

Ritu Baral

quick on view on market? on just the follow-up feedback – give market a doctors And us some NASH the And it? color it. can you European how high-level Got

Germany, Europe, almost talk particularly top-three usually biggest doctors approach of maybe and sort from on about some perspective market cultural in that on Can NASH. had do We’ve you think markets? you it? challenging German to what’s the How about how conversations plan they the And disease? the

Jerry Durso

Jerry. Yes, this is

analysis similar doing of European U.S. progress making So, kind as markets in good we we are in the deep in major market the the have

access, approval markets will we little U.S. be behind all and Europe bit the later. to expect do process and market filing the European the then normal Although around come a in the with of

the tends in more markets where a a a of Obviously, some – of structure the group advanced Germany, some that markets. treaters. consistent the you across to centers the there be – in high look think a terms coming the some where the of there with key of we Europe situation broader broader have is population countries the of I of frankly treatment major concept differences for of the in of is higher where a spread see more in when treatment to in it being you example is back throughout focused theme treat from urgency

U.S. of the markets forward we to our in each again, I the again, initial obviously, are we as on progress. lined process those ensuring up would of us what market looks which in like. with all terms defining in look that Good U.S. more to to in And similar on the into deep And a had are progress details future the going there, for has things be launch focus will been but we first

Mark Pruzanski

with of I face, patients changed only that time sometimes are well thing C and to the is, hepatitis there. long docs same out diplomatically the point would clearly some sort of time. was am of stigma to the cultural think over that pointed conservatism Really, true almost I the add, you And aware these I you I’d with Ritu, alluding , ago

to the France, with prescribe. confident that matter represented is clearly, fibrosis that opportunity this And you just pressing, abundantly we UK, is is in Europe no Germany, willing as in fact are those unmet NASH – in need the be where a there countries clear is What the there. by will and in urgent docs is advanced need and are there very pressing

even There on an is probably comment, more. necessary is as benefit the proposition support for emphasis an to drug. of a anti-fibrotic NASH qualitative This value even more probably a

the Reflection current now, on to in requires fibrosis, a why is if gain then on believe to based the hit upon in opportunity by which there endpoints be rate it’s know, both you drug we’ve improvement, further either As supported our or got a right data REGENERATE Europe. unique again, primary Paper we to EMA two-stage approval

Ritu Baral

Great. all was helpful. Thanks taking It questions. for the

Mark Pruzanski

Thanks, Ritu.

Operator

Thank you.

from Goldman Please question Salveen next ahead. comes Richter Our from Sachs. go

Salveen Richter

good for Ross is Salveen. This morning. Hi, on

questions a quick few Just here.

So, about think they NASH are broadly the highlighted have with if we regarding you guys drug? what just commercial constraints conversations having payers, potential speaking,

Mark Pruzanski

are addressed. that for first are concerned frankly them I that the that most will of which the have most ones ultimately where we about this is implications that cirrhosis ensuring by impacted I other Yes. to area they concerned is alignment mean, are focus the patients about, progression think is ensuring good believe

opposed advanced those to I to group be including we going alignment in good NASH are about think where the population on as we earlier focus believe the really broad that’s is thinking patients. the there how

to specific patients. a So, about talk payer there the a willingness again, I that think group is good of on

that they and that impact need does the we on and see like fibrosis. that taking and on can the where REGENERATE treatment the most on Again believe ultimately value urgently approach we a see think specialist the advanced with they benefit where the the in with population a focus we are I overlap

Salveen Richter

That’s helpful. are And non-invasives. then, identified just lastly here, so you mentioned that a patients lot using currently of

liver does in potential for label? on required is the biopsy diagnosis OCA how NASH if update view So for change a the your a

Mark Pruzanski

know step for of course it’s language. the I atypical of So, I exact the indication that and back question, to mean, But mandate we on label your a premature be statement. regulatory just it to element label method FDA the would do that would take the speculate guess, I of on diagnosis in

are recognized and through in this and world. full the patient we population should going process patient payer process regulatory Obviously, ultimately the the go to be real how define to the

continue is that medical practice. with to payer preferred to do we But see align

we to So, that I ultimately towards physicians. about develops think the that clearly role we a keep play in evolution that have remain confident will talking that both be in market this to and way are going we the non-invasives educating the

towards. payers there to that of be non-invasive that ours the they methods the patients And this drug identify that a patients, which targeted think the advanced they would ultimately, on group way from alignment the out of that like good utilize reasonably one I can types the payers be have first is those should there

Salveen Richter

Thank Great. you.

Operator

you. Thank

Please go Seedhouse comes James. ahead. question last Steve from from Raymond Our

Steven Seedhouse

– to interesting on Good morning. seems the The change increased I more PBC which REVERSE. ask in Thank seems a first, endpoint you. just than sales. prudent. have wanted about and follow-up I But

given reaffirmed old post I indicated it design, on had you draft small a questions wasn't guidance, the the So comfort of the the cirrhosis FDA Mark, endpoint. issuance with few their clear.

Intercept since follow-up new really you of is of endpoint mentioned also, that sense you’re the view you a align the in have an extending to that compared the to the FDA’s outcome consider FDA’s longer so, decided on anyway, this you what Do change? it that given if cirrhosis REVERSE much estimation your XX would guidance? endpoint? month was And did with how REVERSE have made study And making

Mark Pruzanski

for question. Thanks, the

change say with no on and we it out – REGENERATE. is we met reading are fibrosis same endpoint. in NASH that, It’s not clear, important same essentially the the improvement of did endpoint be we to the is Just worsening to this that

from readout. extended again gold what And of REVERSE to the which So, to of to addition do, to that match study double-blind a plate XX the the identical at size just with in we we the the thought did expanding study phase month thing duration REGENERATE. we duration up and do have prudent interim was phase the of

part question? second of the your Just

Steven Seedhouse

Just duration an – did the you outcome study are you extending endpoint? of contemplate the since

Mark Pruzanski

to of we or that histologically well-compensated FX on decided were the study wide something well, below, of that early study going is surrogate cirrhosis range based And so cirrhosis we Yes, fact what into with going means. outcome FX wanted given for the the patients REVERSE we endpoint. the reversal cirrhosis to from

clinical advanced in in standard study took completely analogous more And approach kind outcomes. then, an very – a more accelerated programs. H outcome and that do Subpart to of and but closer the separate we overlapping, approval a pursuit population It’s to PBC

long a number in like that. more of this substantially to because, duration requires – a where to that’s So to sufficient patients a get outcomes population for clinical

Steven Seedhouse

Okay.

Mark Pruzanski

this this had based the this successful alluded just and in, are that, post-FDA’s carefully its grandfathered data guidance in not and because the us designed And this program the pursuit draft of of add that we our on FDA the but what available. population indication on that’s will with totality fact already I fact population. extended only in and we support to you reaffirmed thing is, to They that would is assuming REVERSE

Steven Seedhouse

that you just comfortable with made you’ve FDA’s that changes the the view you? they change don’t And are reaffirmed

Mark Pruzanski

the no. will no, we generate opposite. much important just the drove population. no, It’s in more and Again, they mean, they You I efficacy critically welcome safety data mean, quite that this welcome. this, changes

Steven Seedhouse

the at sequentially top-end the XQ Okay. least your seem Great. And commercial substantially sales, and does of there, guidance. guidance growth outpace imply declines on to seems PBC from at the sales to the even number growth, scrip so dynamics

any quarter? on can So, just you in channel change inventory expand this

in remarks, year the outlook maybe this And you. your for are you number? hold there think that quarter’s U.S. briefly I of sales Thank to guidance. the Sandip, other sales half line that second one-time prepared commented your dynamics the on contributed

Sandip Kapadia

question. Good Thanks. Yes.

Certainly, overall, our our a can meaningfully in again, quarter. IMS trends, quarter contributing see we international is best it’s growth. probably strong think, very I very in you underlying the from terms and of overall had U.S. demand

strong underlying As TRx in outpaced pharmacy orders especially we noticed very our I my did that growth. did noted remarks,

that It’s you growing our would was ours. in for what generally with within like expect product But expectations. line generally a

normalize. We expect that of to sort

we’ll we typical their and time about same to the – as think, is have I at also there think seasonal effects. QX

slower to a vacations and tends be refills bit and the know in so forth. general you with As summer holidays and

we of three. So, sort will a see But strong we impacting that four. good quarter quarter see

performance, had are in the think, given about thought we terms we as I Based is have QX now, way we the in strong changed seeing guidance earlier well. of here we – on QX this we year. the very right are that growth trends guidance great

And high-end or being at at – now, comfortable the – at to be of the the range. expect very we right certainly

we’ll think at – over the quarter we’ll see we how evolves later the summer have a provide and can third to point. I update an

Steven Seedhouse

Okay. That’s helpful. Thank you.

Operator

time, Thank would At Mark like back Dr. the remarks. you. to closing turn This I Pruzanski this CEO over our Q&A session. to concludes for call

Mark Pruzanski

our had I Thanks, and in joining thrilled for on to operator. am on Thanks quarter everyone few worldwide. with leave expectations We’ve the call. PBC you just us ever business. that want points. exceed a today’s continued we key I just execute to strongest

on disease. REGENERATE getting day our beneficial NASH based talented data. OCA external feedback the great strong anticipated been preparing key in year supported the anti-fibrotic physicians, for payers, this patients, in, of clearly out very We’ve people stakeholders, growing day foundation we’ve working and We who in that from great of by company group next liver all commercial recognize feel launch the got profile a currently

Thanks and ability in launch and drive our a look expertise the much to and next to got very We’ve coming with quarter we to the to beyond NASH progress. execute successful forward you blockbuster back

Operator

the for concludes you, This today's gentlemen, program. Thank ladies conference. and attending

may You day. Good all disconnect.

Intercept Pharmaceuticals (ICPT) 7 Aug 192019 Q2 Earnings call transcript