ICPT - Earnings call transcript Q1 2020 | Intercept Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q1 2020 Intercept Pharmaceuticals Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to turn this conference call to Ms. of President Vice DeFrancesco, Investor Relations. Lisa

begin. may You

Lisa M. DeFrancesco

financial for Thank today’s on release are our results available you slides, website posted issued you. morning and announcing and XXXX quarter www.interceptpharma.com. Good on joining first and call. which press also accompanying us a thank position, at This our we morning,

date regulatory regarding call be strategy making certain forward-looking not Before we this like undertake including I’d we commercial development obligations to will prospects, discussion, matters, and call, forward-looking as products to to note future reliance no cautioned clinical update including our approval under we for law. the statements are these on our potential begin our that approved by and during to Listeners only of financial place of our speak and fibrosis liver statements required and financial the statements, statements, NASH; program; OCA and guidance, except those which performance. of as due

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

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

order Please by time those Financial Chief limit question. We’ll initial with will for be Chief begin call open Kapadia. to questions our prepared remarks Pruzanski, allow from in from one to call to then addressed. take followed all Dr. Officer, Today’s and Sandip question CEO, Jerry our Operating yourself to Officer, our Durso; your the Mark

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

Mark E. Pruzanski

this challenging unprecedented first Thanks, Lisa, on Thank We time. during everyone this have good hope on everyone. that morning, for XXXX and joining our you us and remained and in call your health conference us earnings quarter call. families joining good

all how Before diving navigating. the financial as and facing a global and like into we company been situation to results, our I’d we business update discuss are current that have

at Here the to remain colleagues, needs patient globally. and continuing in resolute customers, Intercept, serve and community of we the our strong

COVID-XX of pandemic earlier and monitoring to for of mobilized on secure safety situation the intended business remaining closely, and our take the our course continuity, objectives the focused the in are important We to ensure the year. while steps employees

remote continuing and to employees goes I’d It saying the to working in that and our without new of successful our been efforts thank enterprise drive adjusting determination, solidarity, their like challenging to forward. reality has for

ongoing support our X,XXX to ways compliantly patients With Turning clinical investigational and focused NASH approximately consistent finding and trials, XXX enrolled recent investigators guidelines. with world, across telemedicine, than trials and been visits, in other on we’ve ensuring at trial sites integrity, new safety patients to our our regulatory are the and PBC programs delivery via we of patient maintaining product, measures. care participating home around direct more

temporarily pause X our ongoing. REVERSE, in trial to COBALT of evaluating OCA Phase X X and as made trials, screening combination fully are Phase Phase and our in with study enrolled know, in the as our and you As bezafibrate PBC, randomization We in well NASH patients decision in REGENERATE AdComs PBC.

trials carefully basis. a to as forward light are on enrollment regional as and in restarting We evolving look likely evaluating pandemic, the possible, of circumstances soon these in

ongoing experienced our of potential PBC the any in or chain, Ocaliva disruptions our to clinical continuously to avoid business interruptions third-party we’ve we’ve With products trusted any supply a meaningful product with distributors, respect product this for to investigational result of our time, for as trials. pandemic. supply supplies our other and the commercial working manufacturers, At partners been not our

prescription towards quarter report to the this $XX.X our over year pleased as demand the a perform modestly These our advance that representing total prior-year early with company. million, Looking and sales sales of in the XXXX, the PBC XX% higher first I’m foundation to customers continued than business of trends, anticipated In than net saw Ocaliva net by certain pivotal to expected strong of as well COVID-XX supported uncertainty quarter. results for continued of quarter strong to inventory the solid the continued we first we period. now responded quarter, higher growth the end at during performance, provide the

and as review we On action priority fibrosis XX. work look front, regulatory of NASH, for date due our FDA OCA liver to our target June toward on application we the continue to the closely with PDUFA

tentatively Of course, meeting, scheduled the for review committee advisory is June X. milestone our next important

be you indicated may the host current preparing our publicly given ahead plans the environment, FDA team aware, is it moving with As virtual and is that has to AdComs, accordingly. its

are We I’ve been their robust, and marquee the amongst productive that remotely. that their encouraged by the platforms virtual are facilitate FDA been will format virtual we’ve pleased all ability participants. ensure In the these and that AdComs, execute meeting meantime, technology our discussions conducting working has been to to

the various NDA file indication, complex disease, a of therefore, of AdCom. many NASH these may, co-morbidities which for that first-ever NASH range on on specialties be wide have we topics to by be fibrosis treatment a the potentially for discussed and represented is involve the are With preparing patients at a panel.

expected team next variability government-imposed for patient OCA action and been following pandemic, our OCA we to engagement, our milestone minds. on thoughtful has as Based date, be restrictions and of at appropriate work preparation with a anticipated launch foremost AdCom, be on safety been commercial extensive, based will has review on duration and PDUFA customer as flexible access to prepared launch approval the Following due possible target plan on our the in hard will NASH approval. the launch to Our our and the uncertain and soon potential the

many firsts. accomplished has that company a is Intercept

appropriate the way NASH disease, lead to first the in the commercial environment. in leader again evolving this non-viral navigating progressive that only having the anticipate launch As opportunity it yet seems liver we

for who highly medical care vulnerable patients this hepatologists in remains Our for team engaged, fibrosis up need challenge. significant unmet be advanced gastroenterologists NASH is and the the and population. to prepared with and continue The

these successfully on all confident For reasons, to this blockbuster I of execute in potential NASH. opportunity ability our remain in

final of stronger, that, in word will will health I A our this of objectives collective we pursue industry COVID-XX society the as and once a crisis. mobilized disease. expect conquer industry save be improve lives. the to in scientific to and innovation, company well-positioned in again our to way take entire united has common demonstrate to treat the outcomes, through believe value patients industry great get and we and I to ultimately, pride efforts member the to bio, our biopharmaceutical emerge a more drive need will response

Now, both I’d readiness. on like and NASH our our turn and an to Jerry? commercial update commercial over PBC the prelaunch business call Jerry, to global to provide activities

Jerome B. Durso

$XX.X markets. net worldwide In our which see of achieved good key our Mark, performance prior-year strong net as quarter, growth million and the the Thanks, morning, continued Ocaliva in sales total sales was highest the first good achieved demand and million In of sales, to was we to-date. ex-US These the quarterly everyone. million the first performance we prescription In in sales end international net international market $XX.X results quarter, in in the quarter. we first $XX.X Ocaliva our quarter. reported strong region, the we continued reflect versus US,

of in the not we expected end in COVID-XX modestly manage was anticipated Now, inventory select inventory customers the one, than towards early of seasonality in proactively did see Europe quarter net sales and the in trade in as the to uncertainty US higher Ocaliva response worldwide there the period. the as quarter,

dynamic, patient as directives slowdown see has in the impact a have a chronic medication begun To As you small as Ocaliva’s and give patient know, the physician new some expect, office you of caused starts starts percentage overall distancing of in would on new we context are visits. reduction prescriptions. to a social that

significant teams bit I’ll prepared and prelaunch our impact which little that launch FDA talk NASH that to in execute planning. preparation we’re fully upon approval. to on continue activities; our to then for about adjustments and related COVID-XX make launch, a to making will progress progress be Turning its our

news that as at NASH has unmet patients overall remains advanced with not is significant fact and opportunity moving non-cirrhotic of committed possible strategy soon anticipated the global fibrosis, The OCA. a pandemic impacted following our remain the our we The same. good launch to and NASH with need the our approval exists in forward as

saw encouraged the the field expanded NASH were the fibrosis by digital and we identification on our teams continue of efforts utilization appropriate to momentum to our increased we of strong educational stakeholders efforts our As the on to progressed expand these reach and programming. XXXX, to due educate advanced patients. in as we implications of we based our were We the and depth of able began

of first patients. the the quarter, treating by have over field For NASH example, our to delivered education physicians disease state XX,XXX well end forces

end disruption to healthcare changes to working Of plans caused in we’ve the upgrade and the the therefore, in the first environment. quarter, the launch market to course, COVID-XX emerge has at the began situation account been of system; our for

result last the and XX% patient from visits industry the XX% overall US of across time crisis, a between are the down As year. this in

growing However, utilization and that weekly remote a monitoring an of practically of the telemedicine we is observing increase in basis. patients are on

adopting virtual hospital the setting platforms, community emerging we’re harness looking and both rapidly in this physicians target and NASH been the trend. have Our to

At patient has we launch, our last our extensively NASH and initial about population target not Commercial changed. for December, talked that Day

population care to hepatologist XXX,XXX GI a advanced estimate that the target remains already or in US. specialist, the existing initial of who patients non-cirrhotic approximately due are fibrosis there with we are and such Our under patients NASH a

for we we payers that is see and our on by what critical that We a with success front. know priority launch, remain encouraged the

continued virtual have moved little as with dialogue to to payer any even a discussions payer the Our interruption if progress setting.

our of have corporate-level discussions. we now part progressive to with advanced payers, As dialogue

on are level despite resulting NASH pleased from to demands a see situation. high COVID-XX payers of on the engagement the payer We

same: ensure have we’re target the unmet NASH overall population our that advanced are working today patients our surprises, that fibrosis. a and understanding and clear in exists there with to no Our need is of objective non-cirrhotic that payer customers the

ensure payers, once have we final Our negotiation happen the final which approval, price. a with objective is phase for will and label, to we’re well-positioned the that

social completely just government-imposed result community. disruption a rest meetings right have of of community of the are to efforts educational distancing mid-March, the COVID-XX the and have platforms. educate directives, now, Face-to-face of virtual our physician transitioned as a implementation experienced to possible efforts industry the Since our with not like we pandemic the the so

the with remote personalized through and communications. the teams begun have have physicians We content to reengage education physician field appropriate been our community regularly, posting disease to

programs safe. to we’ve the past additional bring reach to increasing our goal our the the providers. Over healthcare is of launch opportunities weeks, plans virtual to further provide to several and content enable on It our that focused employees also our education customers us and ensure frequency relevant our keep to been

Until the safely back can NASH in in-person we early virtually. launch field, conducted will move that we be our stages of expect to the interactions

from the the our phased, will will We model adjust be COVID-XX local to geography regionally each customer in recovery markets launch customer as evolve. our and we expect have our situations in each real-time, monitoring interaction local of our be flexibility assessing in plan trends so that teams so

final encouraged positions affairs, our with trained local of incremental we’ve we’ve field-based optimize to action and on level, and sales, early personnel as our continue date, teams to the in approach situation for available across to to very market plan as the ready launch measured to target objective medical targeted targeted field of we’ll the as look regards to With majority the PDUFA assembled. I’m structure, we resources. our group take we COVID-XX evolving fully addition the open talent the Consistent of that access, the evaluate and our hired a by and be

and In become category OCA forward to foundational non-cirrhotic for to advanced to we’ll be for NASH, fibrosis believe first approval, continue in will we a look access patients. to from summary, the know to the during is well-positioned market suffering due patients upon OCA situation. to providing we be We these this what execute ready launch dynamic therapy

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

Sandip S. Kapadia

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

and business execution advancing continuity, maintaining Our regulatory during our strong all rapidly We chain business important PBC and steps disruption readiness response to studies activities continued COVID-XX the responded quarter. and our activity. in the support took first supply clinical to while minimize to launch to NASH commercial the and in pandemic, intended prelaunch

million recognized net to-date, the quarter, from our up XXXX. $XX.X million quarter quarter Ocaliva highest In of the $XX.X first first we’ve in in sales,

sales US a and ex-US the approximately net quarter Ocaliva and comprised of million. million versus $XX.X $XX.X This represents respectively, first net net sales Our of of XX%, prior-year of quarter. sales XX% growth

seasonality Jerry the certain earlier, did period. not to uncertainties mentioned sales see the we inventories customers proactively in QX for we managing with QX early the of Ocaliva COVID-XX As anticipated typically overall experience, in response at the end

saw patient our We end also COVID-XX of quarter of to as business. lower the we towards experience new impact the began starts first on the

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

a press this issued for a explanation compensation Non-GAAP non-GAAP of our expenses measure excludes reminder, and full Please expenses to release is regulations. our non-GAAP financial adjusted operating measure. SEC this reconciliation stock-based earlier operating a As morning under depreciation. and adjusted refer

of $X.X million compared $X.X the quarter. for cost quarter Our first prior-year to the million, in sales were

Our are organizational the selling, for the of million and first million. preparation our This prior-year growth launch driven an expenses $XX.X and NASH was general, administrative increase over quarter primarily quarter, by activities. $XX.X and was

the completed to US of launch sales support we the the majority expansion NASH. in QX, force During

line development for quarter. the with in and quarter and million research first expenses were $XX.X Our the generally prior-year

As of of debt and securities cash, XXXX, with were cash restrictive and we sale cash March for investment approximately available well-positioned million. $XXX equivalents, XX,

financial basis. Ocaliva demand for continue we Turning prescription total to guidance year; to our the on expect a grow year-over-year to

Ocaliva Ocaliva line net first QX. based inventory the net COVID-XX-related relatively second quarter anticipated in to with We be the on quarter build also in expect sales, for the reversal seen quarter second in sales

OCA operating to XXXX expenses, million, and investments of our With for respect of we support expect to unchanged to in the to our million remains clinical expenses assumes OCA about and our guidance or action development liver to to continue range launch NASH XXXX. date adjusted pipeline non-GAAP be reflecting $XXX operating in is PDUFA the XX, our and expenses. approved efforts in commercialization program fibrosis due NASH, operating in PBC, other programs, expense guidance This June of on $XXX

summary, can to In strategic proven well-positioned we our to have for a We our rapidly changing and financial remain strong foundation, adapt have environment. a achieve we teams objectives XXXX.

now to operator. turn over call So, to I’d like the the Operator?

Operator

first Instructions] [Operator Young from the with question Our comes Alethia Cantor.

Alethia Young

progress. congrats guys. Thanks Hey, for the taking and question on

as as FDA your focused topics communication over kind due. of that just you recent on little in of for talk what bit and second Just just prepping, really set kind a other around debating kind things really to of And of prep; over and can on me. know panel, that’s kind Thanks. obviously under are term? upcoming I the same far One, of, Europe, on a you guess, guys don’t we’ve do unique are all Would as and think think kind then of being launch US probably about significant couple in doing, [indiscernible] of care patients been the that a of it one commercial NASH education about kind the and with you what the time. long amount of [indiscernible] fair focus kind the early trying a like is with new patient people just patients most [indiscernible] things is find

Mark E. Pruzanski

Thanks, for and second I Alethia. is Jerry I’ll the one. Mark, first the hand one, take this to

date. tentative we’re as remarks, mentioned So, in I X for a preparing June prepared my

and that they advisory and they’ve facilitating are FDA proceeding what confident this with on right, are publicly We virtual for. we’ve committees working is that preparing formats, on been at planning that’s time, stated

is clear first-ever we’ve say I before an topics, briefing so we with and accelerated - we don’t their - it’s approval, of right. and said and can complex until won’t approval this line the to we and a NASH it’s But co-morbidities, book. a respect sight, With this what get significant have disease

up. are a range of there So, topics come could that

for preparing We’re everything.

We’re we’ve progress well based prepared. we’ll the very made be confident on that

the there’s efficacy also surrogate not endpoints be outcomes. of just endpoints; way with to association think fibrosis side course, [indiscernible] at, There’s I biopsy histology these you’d across standardized looking a with reading [indiscernible] standpoint. no under from the what on specific, to the obviously, clinical expect, to respect more the with assess typically necessarily endpoints, so that’s the looking

we context. of but lot large results in randomized and from course, FLINT biopsy So, up and there a a have two could come learned studies, we in great that

literature, side, that tolerability, the And we drug over overall safety more hepatic the lipid have. then or on-target and respect to then know changes are are that And of then that pruritus there’s course one, topics well-known safety moving the exposure very with in our that well. hepatobiliary, and we broadly the being to

anticipated topics the there. be would those So,

could of discussion biopsy. basic all interest means of identifying patients then of given finally, versus And there treatment non-invasive the an up about for accuracy non-invasives, in come appropriate

the are sort those the in range So, are AdCom. topics that preparing for we of of

on Jerry, part second question? of the the

Jerome B. Durso

the question, Alethia. for Thanks

continue pre-approval As advanced the to both likewise. patient, now, then after we’ve up enter true in to period; with and education the in with indicated to and physicians on patients of phase to that’s we’re we once the be terms approval, launch going going stay the focused

of still a to amount there’s work So, do. good

information we information. particularly understanding interested think but do patients where patients know again the So, in side, - targeted more on there’s with effort we do need that education are about the the one a as advanced the

focused in So, an would that on that basis, population. we’ll educational we on anticipate, launch that stay advanced phase

some Of out the are the patient the overall of a course, things this really of population. are to that on more focus that the advanced again, patients make is we’ll well-understood overall understanding issues the message with impact But and sure do fibrosis there.

Alethia Young

you. Thank Okay.

Operator

Our Yee comes Michael from question Jefferies. next with

Michael J. Yee

that a related. guys how assuming that everything how will can crazy what during about and on is, managed assuming and biopsy requirements environment. know Mark. out smooth, are Hi, is talk a goes should first question guys. and you or there? quarter you How about My about would think Two good would approval Hi, care Congrats Street will information for the which about about we require payers not know going it? journey questions

a or a change a second think launch to how Thanks not journey then a environment? so would in requires do biopsy that, and thinking our [COVID-XX] about the that related much. patient get you And how script, whether COVID changes patient to

Mark PruzanskiJerry

you those? tackle Could

Jerome B. Durso

morning. Good Mike. Sure,

which journey of the through a hand are about. on where focus with which and would then phase, window. in six- think and would you would point expect we label that up the side kind to I The the we and you unmet know, with the payers, patients at on question, the as price this fibrosis, decisions concerned enter nine-month we’ve with Mike, that the about progressively, of formally, next first need. a payers with described advanced the we we would move now, that anticipate, they’re importance population is And ultimately, set happen on in commercial where access into land those to time the they first

is have final but and different need which still to make conversations, access they’re being of the do So mind. like those the key think overall that with a aligning the frame at be then decisions in are payers of and for of nine-month see that six- the would And hand on The There payers. on time well window their OCA we elements usually considerations tables, one-on-one payers to look I time which some label still at going we’re discussion. with that on good again, basis where how we we as a that price those progressing happen to period the like NASH. to

on as communicating through occurring And be after ultimately, commercial launch up again, six- those with nine-month the And end of progress in individual you anticipate continue. that course, back window, conversations to progress on to as we’ll we the approval, the would update that side, I window.

Michael J. Yee

was doctors. I we’re out. comments how some whether of impacts think I you And all about out it what has which - at environment, But means kind how to anyone’s different do or don’t COVID see terms waiting have a part the just, have and would different in second comment make about in not it you play plays patients I headwinds really can think some you and see consensus a much. of about so my of in still don’t all drugs environment, to and that? be would see to Thank that think [COVID-XX] think changed this how question there

Jerome B. Durso

key mean the it’s amidst of Yeah. unmet maybe of focus move one therapy The a thing all things basis able opportunity more treatment I Mike, on that advanced have we finally where part in bring think to we the there, to for is that mind, first think, to as close weekly all, to hasn’t that point, market. a and really we’re we’re of more, able changed we’re is effectively. for terms the the that I things about intensely of first progressing is this hopefully, I the to are how recognized it fibrosis looking ensuring patients with in need that and patients market our long-term and get bring to couple

you’re and is at future foreseeable do course, there level. expect customer seeing for and some impact Of that the disruption we

some distancing would. and of in of I see social key dynamic, they dynamic the aren’t physicians’ you due terms to think course, That’s new patients. happening of patients impact as offices this one the normally entering if that, just

we one a some the local And closely eased that does level. on evolution locally directives that dynamic look as how in quicker we’ll watching change areas things that’s at now as are so, be others, than

So, at we being as situations local really look critical. being the as

communication so core good our and do customers a is PBC, disruption we we’ve we it effectively. have with knowledge to that like hopefully seeing it plan of there period a physicians We us base of allows have this these this been work about in customers, that that X,XXX is the good where the group during know some and knowledge about

communications we we is after while our the I that virtual also can we good the both have now to virtual and we moved to communications feel think, a this side, acknowledge on on have the being different model. launch, And exclusively that - education impact and about have other now we’re

that to so, And on react. we’ll continue deep go and

by what’s dynamics these and, exist some I the of on week-to-week really, high focused remaining encouraged unmet that opportunity happening on and that everyone, here. long-term we’re adjusting looking think we we’re unique So, the at but, basis need have a like

Mike

it. appreciate I

Jerome B. Durso

Thanks, Mike.

Operator

comes Partners. Rahimi question ROTH next with Yasmeen Capital from Our

Yasmeen Rahimi

team. taking Thank environment. you on and during for this you’re questions questions continued our Hi, congrats progress the for you. Two making

first if in The is, about [COVID-XX] FDA are with missed? had or regards can any REVERSE we us How one if think with you share you’ve analysis of weeks the of EMA COVID of time dialogue that? XX especially, given biopsies during can the

thank terms of you And thinking you if in the And be unmet that potentially question [COVID-XX] mortality the allows share need questions. be actually this actually data can recognized second it with is and are us. NASH Do then the be investigator you then Many for Jerry, are AdCom how environment think shed if great payers understand NASH taking payers more who’ll in on adoption? the highest is also that from of could side the patients about light the and era? unmet in need patients. for for given you the would of you we’re And favorable more that could some know you as representing COVID far as our

Mark Pruzanski

first the take and part. last Yasmeen, the So, I’ll

meant think panelists as I you AdCom.

Yasmeen Rahimi

Yes.

Mark Pruzanski

don’t we to know don’t they’re who yeah, We - be know going yet.

So, one. easy that’s an

clinical issue; REVERSE NASH majority global XX, about just well, the vast the sponsors REVERSE a cetera. clearly not you ongoing studies, well action and treatment extend asked the but windows, trials in The hepatology in aware of division is you know as dispensation a and and et look, biopsies and it’s and to month other context is the - of biopsy first context providing trials. challenge of of at for The FDA, the one, take

lengths. mentioned I that’s with gone trials in. are be to X prepared very the my that our fully us enrolled, two to starting as great remarks, a we’ve fact position Phase pivotal for fortunate And luckily, in So,

patient - they to exclusively the these focus to retention, can access needed of clinics. we maintain can’t so, measures taking patient integrity if go ensure the and And directly studies, where on essentially

a these the So, everything continuity in ensure with biopsy manner to REVERSE. to window we respect managing are in doing including right studies, in

And the... Jerry,

Yasmeen Rahimi

Thank Mark. you,

Jerome B. Durso

the Yeah. in guess, part on good on have seen question, been to done prior that terms dive middle deeper of getting they’ve think I that’s a And payer the, and of your side, as the for I of we NASH, the progress, think window I the medical risk, the side think we’ve COVID-XX to in they understanding particularly that fibrosis. really, productive I the differential understanding ready advanced terms approval increased become patients have on first and been risk the in the this when reach conversation this able risk about, their

think our and growing I recognition with a there’s I our So, that’s cohesion think the risk, focus strategy good advanced and of again, against the population.

element good in terms the progress educational about this how efforts and [COVID-XX] to risk the understand think speculate exactly around addition I overall on medical community profile, that Now, and understanding with trying view start progression a of that of to I lot impacts a the to think lot interest has into digging advanced the on been implications we’ve engaged premature risk of medical from and result of the side think, of overall, think, do a concomitant I on in the momentum But the think we are with. of a cirrhosis lot of conversation conditions and population. movement been be payers the would payers’ a I I specific the lot of, I NASH COVID the that

the key physicians of conditions overlap think this impact of risk COVID-XX be area the a conversation the I patients. concomitant how of will and across further So, both about the payers

in out something again, play will So, over that, I will think that time. be more detail

Yasmeen Rahimi

for team, our you, taking questions. Thank

Operator

we initial Ladies everyone ask you question, that to limit and in queue. can the reminder, so yourself we gentlemen, get to as a one

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

Brian Abrahams

Hey. Good taking morning. my Thanks question. for

provided REGENERATE talk documents briefing Thanks. benefit you to types or FibroScan. follow-up can that’s that the additional some confidence about analyses extended or submitting you’ve your subset approach patients the I’m you of risk December, of discussion overall in we OCA’s sets data AdCom, back data may as profile? AdCom how, from a updated the in So, on and FDA the in evolved overall, been emerge wondering

Mark Pruzanski

like Brian, Thanks, the and question. I

huge preparations can What our patients, the Commercial period in of Day this, the study was been like on at time, of data our we’ve by patients month we’ve the you time we generate in both a a with As for NASH subset imagine, presented regulatory cut and, you’re XX, of accruing to the referring a course, off analysis that review. set the lot in the continued of to launch of context long [indiscernible]. remember,

the And we so, fibrosis including up happened we a noninvasive up experience testing therefore, that month respect subset from of in analysis we the improvement [indiscernible] to And all FibroScan coming And mentioned, passed through were on standpoint to with months the what point saw way - in very and years. XX continued we minus the six patients able, that show to three you time. interim. plus reassuringly, XX call patients at had month

not accumulate ongoing of years many And advanced scar it the all that strongly in to benefit which suggestive surprising how given continued fibrosis. is that’s takes results

additional to is, analyses. answer your short the are there So, yes, question

more when in expect, briefing have of We, advisory you’d of you’ll in robustness at approval. in our certainly our committee. available discussed support and As more therefore, accelerated data only the see book totality, in that data becomes confidence, the

Brian Abrahams

very Thanks much.

Mark Pruzanski

Thanks, Brian.

Operator

with comes question Baral Cowen. Ritu from Our next

Dushyanth Srinivasan

on guys. is Ritu. Dushyanth for Hey, This

our end. Just two from

reaching in and question virtual what’s treating likely fast more to of understanding regarding comfort second my them is patients payers’ evolving receiving with marketing be efforts, you’re FDA new you’re PBC are those physicians initiations a in your how First feedback format? that identifying is And the progressors? and is, patient the and from that as

Mark PruzanskiJerry

take you Could those?

Jerome B. Durso

Okay.

if question. ahead. new Go last part can initiations. repeat The patient you sorry. just I’m of the So, the

Dushyanth Srinivasan

patient as new The a Yes. wondering commercial are feedback PBC and them, initiation; physicians efforts what’s reaching new virtual just patient your new with hearing format? from the with about you’re initiation on engaging

Jerome B. Durso

seeing been has physicians we’ve we’re group what focusing think on to-date - I of and So, PBC relatively been that targeted with the stable.

been we’ve that’s while PBC physicians really an roughly as team that for disease audience expansion promoting targeted target has we the talk expand, really on NASH, expanded of about state to. were the for the to effort X,XXX So, that communications our stayed stable, we

number initiated indicated slowed see a first I of is new as during see PBC, we during so COVID-XX, similar albeit has as off do what see, do to been visits lower the we of it this patients do new on result in patient which drop in earlier. or we rate, earlier, start has COVID-XX physicians window a that starts patient getting weeks at we And the a although signaled proportion, here to eight as

on really, And data different in that’s It rates. type physicians at one do an and patients audited good do think view isn’t there out you there, when see while at in telemedicine. about I telemedicine, thinking practices is the you consistent look you there’s seeing evolution see via of an number progress, how that. the are in that increase physicians evolving different are

So, this watch that to we’re is going to going quickly. be something

important. I the think things there that NASH couple are we think about when world, of a are

patients we’ve physician have that on that through that the patients of gathered indicated, means for already has that them who a variety targeting you non-invasive been a information NASH have a practice specialist’s advanced and these already be high fibrosis. are will as with group probability in of specialists, and already different have We gives

there are well-known, say, referred. were elements we that about be patients to needing there I think that think some So, the are maybe let’s more patients than

at take things a progress. we’ll as So, look that

less at But with the into that the been patient past picture eight consistent a new have fact PBC It patients we do going is see lower starts that rate offices. again, happening. over is the physicians’ weeks

Dushyanth Srinivasan

just then, FDA how fast are likely that progressors NASH? another to of follow it. to patients and does identifying payers’ the understanding treating Got evolving question, and be Jerry, those regarding And up

Jerome B. Durso

the the the I I payers’ That’s the progression do mean, implications think again their their payers speak mean, I priority that side. their I’ll to cirrhosis. see they because of it’s where and concern. focus, recognize, is

that payers are patients might look is, indicator I patients well with the and progression fibrosis the some at looking as payer, But and being understand do that of will elements notion them their cirrhosis and the those and as the at a for the of fibrosis more is the how always conditions. advanced I they payers the priority we for the that be progression advanced lot of group discussion to think concomitant connection think cirrhosis And at really that be this has forward. the are focus own the at an to think to to one been our the So, how of and times. key continue move the risk advanced see they variability population again, is that fibrosis of as gets I there’s

Dushyanth Srinivasan

Got it. Thank you.

Operator

comes question UBS. from Jacob Navin with next Our

Navin Jacob

the - latest if wondering Number this, corollary bezafibrate with what of pricing beyond Good may. feasibility see if much. you to OCA? thinking if Thank pricing beyond the Two having - taking wondering, Thanks of I to morning. two, you NASH you your the how one, sort Do question. dual about Number other are combinations for for on but in progressing? PBC that, so as potential Mark, are NASH? drugs sorry and with thoughts latest missed differential I feasibility beza combine beza and start

Mark Pruzanski

Navin. Thanks,

the take question. question So, then pricing to and I’ll second for hand Jerry first

with So, paused restart and, mentioned don’t as temporarily evolving regional my we going basis. to the PBC. to material and beza, that have We at this I opportunity a our situation on in carefully randomization a ultimately think to combo to is we’re impact in mentioned, remarks, prepared likely I the study as in looking screening recruitment respect

and things the interruption course, also, standpoint, be from to without of continuing product dose a there a development combo meantime fully the sub. on to are formulation pace So, we the committed in fixed combination continue

clearly results on six as it there in injectable been have last, most beyond think would. high-dose say, the so, semaglutide anticipated X looking in intriguing daily months reported we benefit some endpoint NASH had the long I Phase while recently or beza,

complementary seeing in meet evolve ways. think, we alongside continue directly with that in to a administer of going a is just randomized I our beza, continues things single form the the play combination I have are or to used we’re in of that in mechanisms, think whether terms role a to intend of manner as of in kind we core drug a anticipated simply pill as combination to different the only out the But extraordinarily investigational late-stage fibrosis trials. bar continues field progress demonstrate - the to and endpoint. OCA relatively The point to particularly improvement mid- to be NASH remains two robust in high drug fibrosis slowly. it we

of the that’s, is bar So and high focus. very course, remains fibrosis our

as does what is harder currently all resolution necessarily set more fibrosis translate we defined at saying which but to what’s not elusive that I NASH been saw to most recent we’ve which achieve. that is the along think what - least improvement much and is data

specific So, we keep don’t but have watching terms course, I closely, a of update additional mechanisms. the of in field, very

Jerome B. Durso

had that make we progress the implement think, we us I question the decision an based by have right and It’s you clearly we’ll options sure work. we I as the that strategy know pricing we done, make the on the time and to So to to have measures continue for well. this right all important think information for I

label approval, we NDA option. with separate that upon a name us hope would progress give the So, a and to which that, mean we separate continue and brand

work so Now, deep to at all we’re make of time best have informed it’s continuing the the that the decision, the course, we to decision. do

from product needing as, where well to the course, PBC. price back - that dialogue with and information NASH indication do we’d of We’re we of with set on the this what plan to think, our an label point you continuation at still, as on I of NASH final the come approval also payer at

determine obviously, think feedback part approach. good to at we’ll we customers about are you So best with the and the we finality of But again, to optionality, our having the environment the feel time option right do in and continue be the potentially come And where I from of execute pricing whatever the work is we that. back will at to looking on that. terms

look all I future. right of understand the the that So And importance decision. for the that again, in think we being

Operator

Thank you.

from next Goldman with comes Our Salveen Sachs. question Richter

Ross Weinreb

for Salveen. you for on Ross Hi. Thank the question. It’s

PBC? on Just of NASH one and in you terms that the potential point guys are about this and updates you some here. in any price in the feedback talk Can receiving, differently to just OCA of

Mark Pruzanski

one, think I but... took you Jerry that just

Jerome B. Durso

the I’m sorry, that that’s believe we option best to key takeaway individually just we went. approach. if us the kind where again, for I the the is products of I And price that’s we’ll have determine think

the future and once we have taking final strategic a be then NASH, decision what intentions in in of that with PBC. approach on take price terms make about label, we’ll our However, decision a the set a we’ll are

to come So, back that after you we’ll on approval.

Operator

question next Geoff comes of Bank with America. Our from Meacham

Geoffrey Meacham

Mark, you. do Yeah. to size patients, about question. ask you’re briefly thinking I more competitive about bit touched queue the it, wanted benchmark? you on that already-identified little class a from efficacy And thinking initial how I’m NASH physician rollout. broadly, on feedback, the your What Thank for the down Thanks the guys. into NASH just is Hey, you pre-commercial, effect you And I do based Novo guys the the road just on second insight on the question data? as think about but then, of have an much landscape. the how guess you more

Mark Pruzanski

Thanks, Geoff.

expected size, outsized of and people the lot be data may respect alluding you which to see high how on actually endpoint, a evaluated a the question, particularly placebo interesting me. [ph] to response, they with wasn’t So, effect the that Novo I resolution, the one to to the surprise. the But the we is as semaglutide be took It’d effect with NASH first as clear by quick clearly, dose. saw what take

daily they’re go the a choose design the in to It’ll to going daily which to important a this continue it’s interesting be think to how and they the see weekly, GLP-X. to commercially-approved X I schedule. keep to with on as Phase opposed the is mind is if injectable

of clear improvement, weight and loss, minutes not I So, their expected things the despite no underscoring, with any significant ago, did OCA. assume, real see surprise the feature is a I efficacy couple what the we be pointed unique there. will data again, that I Side out And, what fibrosis just how as NASH highlighting, in presume, on

patients these treatment in of long to course, Phase role out [indiscernible] play the but having a in semaglutide, go that a but So, read we it’s road GLP-X, have saying them study. complementary will we long now expected to have for of X been just particular

the over hand for to question I’ll other Jerry, you.

Jerome B. Durso

advanced for treated on already measurements we who of we window of has think early we know group again, been patients likelihood that the fibrotic. of non-invasive are this who different focused taken determine in being would we’ve and being When specialists already about a liver high condition, with XXX,XXX an that past patient who that variety have Yeah. about of a and launch talked that

they’re already So in with specialist. the

patients I have discussion been we’re that a the the size quarters profiling our disease when significant state of couple type amount we’re patients; to practice, this over physicians that about when past we’ve this gone ones talking describe done good and we the the think as the in through talking can expanded had group work target fact, with detailed we’ve think and and XX,XXX of in that more about thing I patients patients that that that happened the recognize that’s targeting, prelaunch, we of that that window group these in able and XXX,XXX confirm recognize physicians physicians the described. their of are

are we sense right work the good that is dimension. also both done over are recognized side an only focus I clinically on but on, and the not for think got we’ve the the to target a on ones important that physician I us think side, the audience, patient which more So, detailed are that

points I of been efforts. the in of think education that’s progress one prelaunch the

Geoffrey Meacham

Okay. Thanks.

Operator

Our with next Skorney Baird. question comes from Brian

Brian Skorney

guys as approved you the Thanks is it a of signal taking my positioning it as being far response REGENERATE approval you or titration itself? to potentially step, XX-milligram was dose, a to guys. support this really how a are as outline the from dose morning, wondering as you’re and of current leveraging dose positioned [indiscernible] thinking going dose Good goes? around AdCom Hey. Are could data your I for kind as the utilize question. XX-milligram you if

Mark Pruzanski

Thanks, that I’ll one. Brian. take

you know, dose success pre-specified is XX-milligram So, as met bar the study. for the in hurdle dose that statistical the the

to that’s said NASH. dose, we are The the the that fibrosis due XX-milligram met dose, patients efficacious hurdle. in And that advanced so, the we’ve proposing that’s long with did not

that Although to point, in confidence, in activity that clearly, bolters very the of confidence I response is there bolsters dose think the the the the drug. activity biological subset to and the If of you completeness, presented. for for wish that, XX-milligram and from there for that consistent be the are seeing dose daily Obviously, the XX it; our panel are for patients. will only but sponsor once proposing FDA data milligrams standpoint as we prepared discuss the here, these patients

Brian Skorney

Great. Thanks, Mark.

Mark Pruzanski

Brian. Thanks,

Operator

with Raymond James. Our next Steve question Seedhouse comes from

Steven Seedhouse

about Good threshold report, their Hi. you mark. risk. events published morning. particularly, evidence ICER recently and and comments on per know, for analysis on NASH. annual $XX,XXX the in quality $XX,XXX thoughts your also Their that a the concluded [ph] OCA get price just number threshold analysis as draft report, wanted projections cardiovascular would on to I on result but in the

Jerome B. Durso

the ICER I first period. intend that the have mind comment public in provide preliminary. feedback mean, do to that’s during to keep out we We there information think I is

think continue modeling. some to encourage to but incorporate comments, not changes ICER we’ll only of the consider I our the to also necessary

about to some think treatment it how advanced accurately there’s fibrosis be I for OCA. think opportunities should reflect patients with how considered and more with

expect think, of appropriate these topics. in key depth. on also that there in I point So, is work for ICER some we’re of other based changes opportunities a and, experts preliminary as on external continue know communicating have a I progress it from again, us to to we think to ensure some view And what would

Steven Seedhouse

Thanks. it. Appreciate

Mark Pruzanski

in in assumptions price Yeah. see to to is said, the cost only take - target range of with for really mean, effective quality which - going on, ICER. We And so thing $XXX,XXX think where focused yeah, $XXX,XXX their the price clearly made the cost I effectiveness some Jerry cost population, we’re you is as with issue higher And we’re $XX,XXX. I of I’d the work the modeling. north add they

So, we’ll from proceed here.

Steven Seedhouse

you, Mark. Thank Great.

Mark Pruzanski

Thank you.

Operator

from comes Securities. Liisa with question JMP next Our Bayko

Liisa Bayko

Hi.

Thanks. how I’m you any AdCom? AdComs Can FDA benchmark. at experience we Just for look a give will scheduled there’s can much have me. to one your of virtual prior as sense us if a with a quick just curious

Mark Pruzanski

the Xth date an I another review. scheduled a AdCom am sponsor Liisa. June of prior to virtual involving Thanks, and not NDA aware

be think, to I that try to coordinating as tech seamlessly is closely them change, we of test done this that we’re the on that first possible. obviously, will and, the to doesn’t ensure with So, as extent this side the case

Liisa Bayko

Thanks a Okay. lot.

Mark Pruzanski

Thanks, Liisa.

Operator

Morabito Our next question comes with from Michael Chardan.

Michael Morabito

taking for Thanks questions. team. the Hi,

Just quick a wanted update.

payers. had You discussions months to mentioned approval of six still nine with comes there’s once that be to

launched for what - an what approval June quickly being are the and envisioning how given you half you plan, XXX,XXX So, before exactly but envisioning XX, start can everything be or come goes you those XXXX? over I know of you’re product sales delivered patients should on targeting? And guidance, according the if anticipating haven’t are that to second you what to are

Jerome B. Durso

said, is ready as I be soon approval. quickly after possible as as So, launch to to potential objective our

all background other work the now. on side, so, in the as good chain would supply terms launch elements, And of the right planning on is progressing we expect

think I fibrosis, option, of advanced we therapeutic the opportunity been the first when there to So, level hasn’t bring a a so feel product with about to think warranted. certain as urgency patients we

about typical is we decisions. the the is that know we’ve for commercial commercial which months new see side where make as Obviously, to a the payers there be of rhythm a before, six would on we’ll time that, the to window specialty their We nine upon talked key product. do expect

initiation anticipate would we - their for that physicians visit. patients to next know assessing also We at be

the payers taken. decisions formal where, in So, until are window to variability in be going that again, that looking the on we’ll vary of situation will access early be the early some the at period are how

guidance if out we to to haven’t in initial yet communicated know the launch sales side on on but guidance anything that don’t have window. sales that, We Sandip wants not over yet window. I add the on given

Kapadia Sandip A -

I launch. guidance, get mean, too to premature mean, as update you we to to closer but it’s about nothing sales talk add. I certainly we’ll

Michael Morabito

very you Thank much. Okay.

Operator

Mayank Our with last from comes Mamtani question B. FBR. Riley

Mayank Mamtani

question congrats on for Thanks taking team. my morning, and a Good strong quarter.

to the NASH learning attain the Mark, maybe, and just both tactics end on follow-up could progress if then PBC customer more requirement fibrosis improvement? endpoint be any being that patient could so on remind on you new and to us quick much. if Jerry. remind relatively you similar? to starts applicable need NASH, that if EMA there’s the deletion patients you could And Maybe you’re one Thank Just front, given on just the in us about there’s any where

Jerome B. Durso

I have education this that and things; and we promotion. opportunity, side, we’ve learn in-person I historically mean, a of think PBC, how and is the of digital OCA opportunity and in lot recent means fact taken to a with market promotion, on the lot are we test we in the just window both taken have to mixed the the not but this

So, then in a the there learnings. we’re lot being test and apply - It market into with things the advantage of, even consistently in accumulation has we have before is a launch of them had opportunity that been big period in PBC now frankly, plan. to to the customers, these and

that’s been So, rich a window.

a on focus right give things in we we’re side communication, that feedback to will PBC the things some the considering on now in or virtual with period quick are some Now, on PBC the some which market. side doing obviously, us actively

which NASH. group us, for So, will of that’s of importantly be of real-time us a many important with again, physicians kind opportunity with the for

because So, in through of pulling launch. things lot a incremental that’s the before part company. of being fact of we’re this of advantage into we’re obviously we the and even a learning that focused us the and applying think liver market And an DNA period of company the

Mark Pruzanski

time. just And Jerry. Thanks, we’re over already

quickly last late as year. you that side, very on EMA So, know, we [indiscernible]

one typical so period. or the review expect We year

fibrosis and please improvement. meeting two-stage [indiscernible] And on we’ve yeah, guidance of fibrosis respect improvement, until that’s and NASH that supplementing I if or in reflection So, primarily paper got next it don’t And the year. supporting launch have expect you’ve Europe you least approval endpoints, the to know, requires think alluded that to demonstrated either core endpoint as confidence with improvement we the resolution, with or OCA. out it, at you

going position great European got we in we’ve review. So think forward a

Mark E. Pruzanski

to know didn’t I With that, some we questioners. get

And safe. you. up so over you. all the course listening of Thank Happy you follow and We will day. do the for in stay to with thank

Operator

gentlemen, conclude Ladies and does presentation. this today’s

You now disconnect wonderful and may have day. a

Lisa M. DeFrancesco	Vice President Investor Relations
Mark E. Pruzanski	President, Chief Executive Officer & Director
Jerome B. Durso	Chief Operating Officer
Sandip S. Kapadia	Chief Financial Officer & Treasurer
Alethia Young	Cantor Fitzgerald Securities
Michael J. Yee	Jefferies LLC
Yasmeen Rahimi	ROTH Capital Partners LLC
Brian Abrahams	RBC Capital Markets LLC
Dushyanth Srinivasan	Cowen and Company, LLC
Navin Jacob	UBS Securities LLC
Ross Weinreb	Goldman Sachs & Co. LLC
Geoffrey Meacham	Bank of America Merrill Lynch
Brian Peter Skorney	Robert W. Baird & Co., Inc.
Steven Seedhouse	Raymond James & Associates, Inc.
Liisa Bayko	JMP Securities LLC
Michael Morabito	Chardan Capital Markets, LLC
Mayank Mamtani	B. Riley FBR, Inc.

Intercept Pharmaceuticals (ICPT) 11 May 202020 Q1 Earnings call transcript