ICPT - Earnings call transcript Q4 2020 | Intercept Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Fourth Quarter 2020 Intercept Pharmaceutical Earnings Call [Operator Instructions]. Please be advised that today's conference may be recorded. I'd now like to hand the conference over to your host today, Ms. Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs. ahead. go Please

Lisa DeFrancesco

and morning, today's Good release you joining at XXXX for our on is Thank Web our This and morning, on site results year full call. quarter press position, we us which fourth available you. www.interceptpharma.com. and thank financial issued announcing a

our except which we product like to regulatory Before making statements including law. subject of undue These forward-looking I'd that as prospects, and this development only the certain speak to strategy on approved to the program, of clinical forward-looking call. begin and statements statements, are and number uncertainties. on undertake reliance date are we and and discussion, believed to call, And obligation guidance uncertain during although matters, based statements, assumptions that, performance. regarding of inherently note and these a statements and financial required forward-looking no estimates place our cautioned be future we by be financial our will as such to are not reasonable, commercial risks update Listeners

remarks team Gail Senior allow the Some Medical and addressed. Chief time from Financial Today's anticipated our to this to [Operator historical questions differ and all to actual or and be our our the PharmaCo available could Medical SEC. of questions begin question materially order release call and take be Affairs, Please and are Officer, your yourself then Cawkwell, leadership from Also press Chief Vigilance prepared but morning's in Sandip limit for to President public all open President Instructions] for Safety Acting our to that one questions. our cause from with results call of periodic Officer. Vice the We'll Kapadia. risk will those forward-looking by filings or not in CEO, predicted results Jerry statements our factors discussed by our Durso; in will

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

Jerry Durso

on Thanks, Lisa, earnings quarter the and and good XXXX Earnings. chapter. am morning, how everyone. lead call we us company by is so next of I first focus as begin Thank This as on I CEO to excited Intercept, for our fourth joining to want saying our you my

any as I more and expect I also with from As new fully leverage and to pathways there in growth we and challenges. opportunity, capabilities our potential on for many now execute I disease. objectives R&D for be our liver future success sit, see opportunities But where importantly, commercial

talented a many Intercept, and new people dedicated recently leadership the to we addition announced important at In appointments. number of

believe pipeline. additions Europe, the right leaders I With regulatory next with and foundational a I is the us. in key team, including US that objectives very and experience the XXXX, our on same are assembled and on which in NASH phase our many process opportunities team ahead of believe group and clinical of our our these strong to of embark with journey we've of and expanding backgrounds, strengthening business, diverse to challenges our furthering the our as PBC executing goals execute portfolio regulatory include on this we

over business pipeline XXXX before by update discuss guidance. financials rare our today the our on I'll to let and core provide begin update to NASH, in update an on I giving an our Sandip provide our on Before me then disease turning an call PBC.

facing, reach evolve organization, to most in areas. XXXX We've And each year, strong community community. virtual these continued challenges of care PBC competencies say, We channels education achieved including to patient new coverage, distribution, ground continue stakeholders. And of the XXXX our educate Ocaliva, including growth despite as to each the centric experienced global in gain and and an that Since product strong payer for the of was sales customer system. our the we liver the where in face year pandemic. core we've milestones introduction proud to of in new we've relationships health in organization, specialty the expanding COVID-XX brought of built our a deep to I'm recently, growth use Ocaliva business.

For full was we of over sales XX% year the year. achieved $XXX growth XXXX, net million, which previous

facing strong term patient long we over anticipate and the important has overall. due of starts Our community. lower global impact with data new visits pandemic a new particularly performance resonating our by to been do continued that fewer to was result a patient we're five year is The supported business, as specialist not

our future are PBC, appropriate an considering number current mentioned, gastroenterologists opportunity, trends previously PBC This updates efforts When To the we're more yet of educational PBC we our continue business to educating identification earlier that long continues which Ocaliva. I most in on with we we in education an PBC, talk opportunity in As is I'll in Ocaliva date, the that supporting our setting. have given patients and of advanced gastroenterologists launch, believe considering about important the and in of label represent our we've to important Ocaliva. appropriate the to based been considerable community of number strategy Ocaliva community moment, the stages process. of prescribed term of not that US anticipate patients about the expanding the have XX% since on the patients a

discussion provide NISS; with future post discuss to business, I identified continue which of signal, conference. last earnings PBC PBC. at studies activities; wanted discussed post regarding most of of key our two also marketing in on Both and call the marketing our update we the newly you our we today on investor revaluation recent the our to or an and As safety

process First, regarding NISS. the the ongoing with

of completed and post marketing an safety NISS FDA key consisting had patients ongoing. data, a remains and analyses safety As subset marketing comprehensive was the XXXX. looked PBC a a of liver you discussions, cirrhosis. marketing from previous epidemiological for post disorder our an FDA in was or We identified potential clinical basis. pharmacovigilance to It from on routine These classified a assessment during know monitoring data process from in with in post as from risk information committee, DMC, review, earlier meeting we trials, at were This one. to quarter our and studies monitoring our assessment including data provided which unblinded a

most We'll further in our updates We're of labeling ultimately on date, FDA based a now stages when with However, changes. on PBC. concluded. working the process advanced will to to with interactions provide the regarding it with agency change the these patients the result align is

the years XX% of those line wise. cirrhosis is PBC cirrhosis. PBC patients, severe bit that Patients the mid in a estimated treatment, reasons cirrhotic. on than disease proportion biliary make to biliary total up population. the of the This overall from which are project Ocaliva majority in digits, of main with percentage with are ago. We primary decompensated not single of most the that with cirrhosis decompensated evidence is of of is one cirrhosis a a with range. those about subset XX% PBC the of with progressed include the second patients communicated, smaller population, Since previously cirrhosis, The cholangitis Ocaliva we’ve most higher the we cirrhosis, of As name the advanced primary patients changed patients patients severe to several was with

are the we stages remains on with process where Ocaliva summarize to now, we're And ongoing. label FDA FDA updates the right working on NISS. PBC. the to with for patients of advanced The on with focused the So most

trials. post PBC Now marketing turn to let our me

discussed reminder, a PBC, have also recently we As marketing in two controlled placebo studies post regulators. with ongoing we have which

First, advanced are patients XXX which impaired. PBC And study patients who for is confirmatory hepatically with COBALT, is of most several hundred smaller study, our a study the which second, advanced PBC. the

the cobalt with in again, of second who blinded advanced we XXXX, the unblinded control, As only to the to second DMC study data scientific the controlled treatment conducting to external our and dialog clinical with These We DMC indicated modifications to placebo revisions will And our to to a label from also open are that concerns FDA the submitted report DMC population Ocaliva commercial Ocaliva, design focused patients patient potential feasibility our considerations, PBC We're discuss through patients were believe concerns. study further consider benefiting label we our an Ocaliva The retention, study half on related information, and running we ongoing the of the The across the not look Ocaliva related underway findings given We to previously as our spectrum from EU. of this approved including feasibility conversion the study. quarter. trial important including to availability changes modifications were the these studies support there have proposed most this the modifications the label the reviewed proposed ongoing recent the in an were raised advanced population. a meeting for design and while influence on is to design. to they of as communicated on it's trials. to DMC future course, cobalt patient designed. safety, particularly feedback In think advice from concerns both a of from but seeking line we and the the trial.

advanced fibrosis. regulatory OCA turn let in our Now to NASH me process for

of our the Our XXXX. US potential efforts NDA the of remain ongoing towards as by we end work resubmission in

reminder, ongoing patients X only antifibrotic with Phase our Phase fibrosis. NASH X demonstrate efficacy positive a As to in the remains study study REGENERATE

we a the efficacy internal items coming number to FDA alignment a benefit for utilize methodology strong a any external be the interactions a that process goal profile. have and gaining view key a resubmission. and these risk what of with able interactions on OCA be data in include focus potential areas to biopsy key over for prior will We of additional we've team safety, of series comprised and The a expertise, the of support with potential we initiated months, to of may the comprehensive overall expect

we This providing areas, safety support NASH of We with initial of underway filing a the FDA, will understanding fibrosis. where and have provide data an preparation the to profile us key overall the seeking opportunity effort have FDA and with will FDA.. that to discuss with focus safety of OCA potentially we from update to exposure as on including double of amount we're a safety greater to our safety refresh alignment specific actions increase these comprehensive

study with it's a can important we note we gaining on this focus of support important As ongoing FDA, to to resubmission. that have potential process produce alignment an we data with where REGENERATE, to continue

important looking in In second data Europe line to are forward learnings top Furthering in our questions year. cirrhosis readout compensated As file a XXX represent underway The in population, reminder, data. evaluating very for also this the where is and expansion large our the remains of much to submitted we stage REVERSE, the the areas study, We later due by have Phase which focus we're of our portfolio for responses anticipate work we in NASH US, day parallel ongoing. the NASH. X XXXX. opportunities REVERSE with patients and a the is the of process readout review to will of key pipeline and on OCA to end

continue trial bezafibrate share is in so Phase estimated the US. data. enrolled, an the enrollment able be evaluating once with We enroll time the to of with line our trial outside X for far. to rate And We're we'll fully of combination pleased OCA

remains generation with next made INT-XXX, believe for least one to forward FXR which potential candidates, it expand in January an patients. of with the committed combination XXXX. the doing the PBC. a important product significant OCA to IND enhance a we US. there's move as patients our And work for look and decision bezafibrate Intercept we We to We agonist, profile. to development in a of we in also We've believe will the human new has innovating And great as internal fibrate combination first the for to at forward prepare opportunity the of also into be approved, OCA differentiation. therapy new for if a the filed

call So pivotal a our the Intercept. priorities Kapadia, of update. number Sandip? underway our There's financial Financial XXXX will year, over for for Sandip overall, will help future turn this Chief be to And company's success. a which now year Officer, shape a I'll

Sandip Kapadia

year good morning, date, refer Please commercial performance. a of operating in earlier for to million our in XX, of press XXXX. to results issued the financial reduce highest sales, continued our net quarter forward. in Beginning with worldwide ended from efforts today recognized to the for strong reported Thank you, the summary and $XX.X fourth fourth XX% as million Ocaliva results financial full full well and we December In quarter release sales our as XXXX in overall $XX.X expenses growth our progress with Jerry, of our XXXX. up everyone. going net Ocaliva worldwide quarter, We quarter

worldwide For sales the in the million were $XXX.X net full year $XXX.X to Ocaliva XXXX, prior compared million year.

net representing and full net comprised XX% a Our sales million US million, and Ocaliva sales of year respectively. XXXX net ex-US $XX.X XX%, sales of of $XXX growth of

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

For GAAP operating the full expenses million. operating $XXX.X $XXX our year adjusted million XXXX, were expenses were non-GAAP and

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

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

For million prior compared of sales the as to the were million in cost year $X.X XXXX, full year. $X.X

of cost related and sales primarily packaging, labeling, consists expenses. Our of materials

Our to represents selling, of NASH quarter, driven a initiatives as general and our result costs for the postponement decrease prior reduce and million. a fourth the million the of administrative the was quarter versus year $XX.X This were expenses by launch. of $XX

the to activity to For year from million. by full first preparation and $XX.X $XXX.X the approval and due the increase NASH. for with selling, million to associated launch An expenses driven increase the The period was in OCA of of XXXX, commercialization administrative fibrosis potential of liver period year. primarily full expenses over prior year the half related increased our general

quarter. Our research million $XX.X million $XX.X expenses the in and to development quarter year XXXX the of decreased from fourth prior in

driven development and development year $XXX.X the XXXX, as year to and and million of conjunction costs, severance R&D decreased million research These studies. and lower the months costs $X.X the for the and activities the $XX.X of was development decrease tax expenses in of for ended Restructuring $XXX.X million to XXXX a other in The XX, compared enrollment UK expenses NASH For $XX reduction by conclusion expenses cost termination year. primarily full December prior plan. in REGENERATE respectively. were with were including million the from comprised for benefits recognized and credit three research and million, expenses XXXX as the workforce XX REVERSE included

with debt XXXX, financial now securities XX, December of As positioned guidance for sale of equivalents, for cash restricted we approximately investment year. cash were million. and available well cash, $XXX.X And our turning the to

XXXX million. year between assumptions include We following. the full expect million $XXX sales net to and $XXX and drivers be Ocaliva Key

we our population, label or contemplated and those the believe occur timing year. that the anticipated potential prescriber guidance we PBC of of in to First, changes will scenarios changes range most advanced for of the have

the We will and information. year more plan to throughout refine we update as have

lastly, would patients as expect typical first factored continued And impacted reset pandemic. gap. in of result as lower expect COVID-XX in gross Medicare the plans Therefore, deductions as reminder, are also insurance to net in higher a QX with of coverage quarter. and we seasonality have Second, the a new the enrollment impact we

PBC We while be as advancing our expect year refocused resource to our continuing adjusted $XXX efforts to program during expenses XXXX full efforts $XXX our of between our The half non-GAAP commercial streamlining of guidance we the NASH operating reflects on XXXX back the and million. have impact to pipeline. million

strong I'm this commercial in has So cash pivot ability resulted in position strong and expenses with and entering pleased to year. reduce quickly, operating overall, performance our XXXX the which a

NASH including support and our REVERSE the key leverage strengths. regulatory the on growth continue focus our REGENERATE our to FDA, with finding ways process trials, in Ocaliva will We clinical business, and our fund of to invest

possible. one Operator? that, with over the like I'd as I’d up. that Thank operator to you people question follow limit it to So turn and to we’ll ask the any questions. reenter for you. any queue to get many for And as yourself

Operator

Yasmeen [Operator Instructions] Rahimi Our comes Piper first question from with Sandler.

Yasmeen Rahimi

a years? the patients. by, out, years two REGENERATE years, patients have to four on on now on understanding data XXX was I flies for already three Time have since drug how wanted been many REGENERATE almost the completed it's better on two years, read So being study which

you recently, see that in provide in post comment if year two. regards the want they So could that data to as FDA this really to stating

So thank taking my if you how you could check OCA? from that. second on And question little And questions. a quick provide bit you then differentiates color is, and can it for XXX

Jerry Durso

REGENERATE while has We ongoing. out read for a that patients mentioned, at As now. of you group XX ago been months

including at moved completion reminder, considerable the event the the a portions which who that periods, of completed that time are Enrollment while driven there study, of through overall an the was window population XX as based is And obviously is are have the time. subsequent on study, a month ago. this So to events accumulating.

example, away. have elements is years period preparing piece that later the ability time are that numbers that is some for now patients a in discussion. us, So one for to update reached advantage of larger The of the safety take for we the of

think, we expect is look be And updated OCI. it's of the of view at safety an of safety we us comprehensive of and that the I look a key again, appropriately. part allows of the safety the elements align doubling the some in terms to will roughly study over the one I update of think to the that again, agency that element exposure cut with of data as ongoing time

first plan I initiate year. a remarks, FXR. as do bile is It a acid human this did prepared XXX, on to study So the selective we mention in in

based models models. preclinical for differentiation, some the from potential there's efficacy of for potentially the think of I on some greater

we and XXX more on communicating as forward. be will more move We work doing

Operator

Raymond Steve from next question And comes James. with Seedhouse our

Steve Seedhouse

or a or the would clear whether even. not with cirrhosis NASH you're to dose respect obviously, to not me have NISS change It's to entirely study, specifically anything NASH, higher implications titrating the

that? you just comment on also IP is on can And XXX? the just So quickly, Thank you. what

Jerry Durso

So at is Phase the is cirrhotics, a cholestatic patients. fully talked based over It in first of marketing disease. compensated enrolled, The is we've as committee, on trial, for reviewed data not has all, DMC and continues trial regular ways that are ongoing. any the necessary DMC, to the about, a is And that taking of be our look REVERSE monitored all is basis. PBC like post the monitoring back PBC XXX this, group study study X in recently, including come on study the a the changes. a recommended environment. large REVERSE the NISS, second and

we read look forward It line continuing out NASH, the to again, our trial. this by year. of the of is REVERSE plan to condition forward end different is PBC a and on So and top

Steve Seedhouse

mind the Would commenting just patent protection you on XXX? on

Jerry Durso

I don't the IP on yet. Yes, we've commented believe XXX on

Operator

with Young question next from Alethia Our Cantor. comes

Alethia Young

just what's and them. through can FDA any the curious kind and of if work that on going are what the as and I'm or you with there, recent maybe about around of with considerations confidence your what you NASH talk precision kind new

Jerry Durso

you repeat first part the little You a low. can Alethia, of question? were your

Alethia Young

your having FDA I'm they're and around the NASH. just curious of about with like conversations kind considerations

around able visibility refile general there Thanks. year any going give more to and what's being can you ends? confidence If on the on granularity, before kind of your

Jerry Durso

others. tried terms the any, have including comprehensive ongoing. if areas around preparing important refreshed potential We're alignment is having And prior are as resubmission. that an update then important. resubmission. of benefit asking efficacy might of on highlight through areas, to in real process, It potential OCA. have that course, the a the it And safety risk that with on we're be of heavily we Alethia, think additional that and safety FDA we we to engagement data the of that one a work to The alignment We've right of going this, what inform is discussion some a ability think to key process we're key is is the the the I priority the approach and discussion of initiated with most biopsy focused a this again, right updated with

continues the We're would at an work. the ability the definitely at update we discussion, And as data. not have provide and come refine, to we're going point. doing an updates So to, providing generating that back granular and process we're but we each to look be to forward

mind. other has it's OCA, the believe a have that's that patients the fact that motivation with focus. in large group to and a due we the shown in of think fibrotic we that's X to that for continue These unmet I our that part to to thing keep that high is only of the Phase important advanced patients need, still antifibrotic continue effect are

Operator

Michael with Our next Jefferies. question Yee comes from

Aryeh Gold

to and for resignation And thoughts impact have is gen the any safety Michael refiling? relating just to question This get potentially potential with try Gold second on recent on Yee. second and wanted to Aryeh I your the to tolerability that CMO will the benefits of FXR.

Jerry Durso

We remain focused on efforts. our NASH

on I new I we the were ensuring focus onto at Morgan, also bringing for efforts that program. a folks we history on mentioned fact example, of have put perspectives real combination NASH that that think dedicated a new considerable with the in the the JP with team

efforts. team So the remains of in the ongoing all

You did been to that changes the the team. mention there some leadership have fact

has in right we next been take a steps to think, for I me the the focus ensuring the period. clear team have first

changes play I to while. additionally, on new a to succession for top with folks transition really on our like journey positions, Gail, some new leadership which and and with having the having chance I've step folks talent, our perspectives an with who have of bring think leverage the experiences opportunity always also strengths good mix a I their new and been talent bringing Sandip team are that, into been But and are also some a folks pleased, reinforce Intercept and think in, ability to folks leadership some a some having planning, in during anticipated. different to existing some some through us creates

point. at on are we where good feel the this leadership I side So

Aryeh Gold

second-gen FXR? the on And

Jerry Durso

your was What it? on question

Aryeh Gold

new you're preclinically? tolerability seeing potential that safety FXR, For any benefits and the

Jerry Durso

both the Again, believe that potentially there's there's for profile. also reason better I think but differentiation to overall efficacy, on

again, far, the come promising based back more we steps. now data so over as the with but time insight on into looks So, move next we'll XXX early preclinical work,

Operator

next comes UBS. with Our Navin Jacob question from

Navin Jacob

of to it an if scenarios here. us of change help be that wondering Would are the cirrhosis scenarios could tough could What type Just But Jerry, are of that comment at if just or could this. while with the through just wanted here? warning? that that out play exclusion some label it's Understanding walk to -- individuals you of us ongoing. have type out least you of come potential a end discussions scenarios maybe could the book

Jerry Durso

bit I'll maybe talk Navin, a guidance. to importantly, is the the of then context So maybe ask start as process in ongoing. and Sandip said, you little

the that today So to get specificity but given into we to we the on an it's based certain information wanted provide will level of update continue. have, difficult conversations

potential the PBC. group the I to stages see outline then, to, And you give was advanced of fall again, what of on stages the do prepared think We've range to with in the and of them. how we updates into these I different remarks tried to tried patients for are patients finalize, of most we guidance, scenarios. that a working course,

in… any that do So the context We'll is as you additional complete. to definitely is want back give ongoing. process come Sandip,

Sandip Kapadia

the believe, we in I in prescriber the that occur the changes announced million guidance XXXX. I the for could of think, health we mean, But of we're anticipated I to today we've label more contemplated advanced worldwide say, What $XXX say the scenarios of timing. is, with would along million process. sales $XXX PBC population, patients sales the I'd midst in

the I more say to some what is continuing we guidance But update learn around at least provides information. I context that. think as we're and would refine So current

Navin Jacob

Sandip, that. if on could, just I

in quarter? missed is annualize couple But we just So here things basically think A on. you flat, do as the the a there about comes it's guidance? should guidance QX? did QX. it's trying effectively come the sort drop potential it of about you saying there to of I'm trajectory what from until your approach potential the think course if how QX, you then sort this conservative burn kind during label so flat that. change in year I on build of the just was demand phasing Sandip. to during continuing or Maybe annualizing understand inventory and or of you any took Or apologies, effectively then And doing of just of the think, or Did here was a annually demand? I to

Sandip Kapadia

at but I the first in a with see a every of question anything significant. respect there think, of Well, bit inventory little tick QX, terms changes to Usually wasn't in up year-end, that's faced year, we I the do have Medicare in and of coverage first see reset mentioned, the see as that. plans And you'll also typically, patients then, course, just gap. as quarter insurance

We to have higher quarter. gross net deductions first in the

to and growth there. then softer be post tends a first quarter bit So

some is, say along label a and for update like factored update our can you sort of I as at what least think in in potential we'll I of of we've terms thinking now, right the way. the range, So and the

Operator

with Skorney Brian from Baird. comes question next Our

Brian Skorney

an of product? fibrosis maybe narrowing get the targeting there the like patient outcome language of I a with of approved been a on would enrollment, increasing F-Xs successful Just FX. FX, trying to some broader with the addressable can probability to there maybe and population seems for advanced indicate in patients NASH. you the a label broader that idea parse And know in had REGENERATE were for due here It goal the potential aligned NASH,

you to focus or or enrich patient Like limit in an to to the FXs I'm maybe the try that? thought than targeting of to just kind some is So NDA is FX FX, population and wondering, narrower just criteria other are it the something data?

Jerry Durso

study the REGENERATE interim impact the The reminder, of a fibrosis a a analysis an was was on the group FXs were FX that wasn't in interim that as in population readout of part were successful Phase so FX. that and exploratory, X, So result. in that analysis

depth when So of in month had we talked response We've time, in an on around been population unmet this our has the because commercial our parallel. population FX, XX FX letter think high about of the fibrotic I the advance the in over discussions is and need. FX more always particularly advanced results like some assumption complete commercial advance, level of focus focus the plan, the

I around opportunity in new data allow will into this in think us we're us with safety overall, process benefit the the picture, FDA bringing I think risk the dialog that now for to risk that from was have initial population the of readout a about to benefit FX, of thinking group resubmission. context But potential discussion FX around the again, the right in the IA REGENERATE.

Operator

Baral with next from Cowen. Our comes Ritu question

Ritu Baral

like is reiterating sounds think efficacy the develop for safety re-review update. to do prior comprehensive at likely, submission any talked point? some efficacy you're that XXXX you and submission it hook of What as submission interim odds are part not or Jerry, you this of have indication sort this potential a you'd So about that new

Jerry Durso

focused as and remain that those our plan we'll progress the potential Ritu, is a alignment towards for on the I So of said, and XXXX. resubmission through we with work interactions the by FDA, end

I on one. as the these so safety areas. a we're intensively And why focused mentioned some update of key that's key

consider what Our for with context. any the efficacy in this conversation the depth in in additional work be focus includes based around potential on thinking and looking FDA to would our along that safety,

component alignment on. I probably of intend efficacy guess the can't that, work process we additional part and the is definitively much to I except through than that that more an go So topics this core

the towards benefit right Type ensuring example, and the the year Of had, course, meeting that focus on we end FDA with equation. the real discussion in of on last the risk with conversations A the of both sides around based for

Ritu Baral

squeeze going follow-up I’m to in. one

can before complicated COBALT label than to some more flip history is and turn sort Do Just switch over natural you of an have patients XXX analysis or as the open it those far extension. you and converting as generate that? into

Jerry Durso

as an the We proposed COBALT, recommend. on around So would and is dialog I a mentioned, we ongoing. had label plan including the control that, open

Of now. ongoing, definitive get is course, dialog can't since on the that more I

whole this other there I that's an important design that revised for what the one other of the is is potential of component revision and discussion. might label, is final right think interdependency the important be points and that's a to and that design the between

Operator

with next Michael question from Markets. comes Our Chardan Capital Morabito

Michael Morabito

FDA? provide expect be information, to safety I that timing which with upcoming data you on any bit will may in cut you just there the have can the on when that on involved results of you based details to any and Have little you share happen, finalized wanted occur. that do to trials interactions data to get that any Is the cuts safety on when more plans potentially the delay a analysis? try of the

Jerry Durso

start. So maybe I'll

in important again, as are said, working I resubmission from part that safety REGENERATE would work from on would any an to NASH well. patients what emphasis is it that's safety potential of ongoing. since the exposure look gives an heavy We from of REGENERATE. we due we fibrosis other team. with through for And as as our So a anticipate update that component, be more in update on at the process significantly safety trials update Also do the the again,

Again, the and safety means, from agency the safety will discussions. with discussion is component to set we what alignment double analysis the what of of this ongoing expect, Of course, exposure important was on some data the included think profile initial focus be the overall that opportunity OCA. that of we of data these the in in overall approximately on file the an the

Michael Morabito

on a to are or have no safety signals, safety additional this that. worsening positive just see Is of safety continuation cut quick outcome follow-up a of data profile that time? over I with you in same looking a the you seen seeing improvement guess any

Jerry Durso

of a it's our in and the that important, the overall going So course, at to the overall to the get agency. of with to going discussion important be be view refreshed context safety and is ability look to

Operator

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

Brian Abrahams

US? I have be cleared? done combination Thanks. cycle question trials? US a life And the that Has I'm on to just the your into differ bezafibrate move OCA outside potential. IND US needs to how what with else of the from approach studies might there wondering, extension

Jerry Durso

this start and one, can then I'll Maybe Gail comment. on

I to on medicine PBC. for think, progress first, in opportunity our the us next

the reinforces have we us, term and rare diseases For like think, long in interest I PBC. cholestatic

think X from the data with to that that it think for the gives work And but we at key There's significant that an on data and you the PPAR. potential of you and start the US of it's I OCA, albeit say, it of we indication Phase some amount in us of bezafibrate outside a here. PBC, as think interesting there's elements access bezafibrate a in as the can trials some also on maybe, Gail, little good about have the ongoing, look combination as that's now. US, we that house so investigator competitive most bit we comment in a opportunity to US, initiated the importantly,

Gail Cawkwell

as IND an additional us said, to of later more US different milligrams. about an we X us provide That bezafibrate, work goes and the as have with help the in are pharmacology Jerry this X OCA US. filed an the right to more the doses important have Phase get two preparing titrating progresses pleased of as very the the program we our We've study at in X year Phase So update At ready ongoing enrollment to of study year as US, the bezafibrate been milligrams and combination X start understand Phase dose our arms pandemic. to in our with will any and Phase is same to that should study OCA enrollment We as includes time. later. start dosing two clearly X XX well clinical time, on titration Phase part started study, outside have X at the in despite the since information

Operator

& Joseph with Company. from comes question Needham next Our Stringer

Joseph Stringer

and on prescribing earlier gastroenterologists percent You Ocaliva. mentioned some metrics of PBC

your patient if for the or of key addressable to tier and wondering you target could you. market Thank you patients? next Just the maybe in penetration unlocking what what is, population speak current sort is PBC think of

Jerry Durso

over opportunity that had time. and in efforts Ocaliva at to big education getting when our community it's we've continue the that the expanding educational a of our of, gastroenterologists there a part strategy, It's a we appropriate And number think way, I been to move. important more is we'll the think of center are focused dimension based of I the are patients that have, aren't that therapy. you for considerable consider that PBC

tend their in PBC a gastroenterologists relatively few patients have those number potential to Now practice. of

particularly also second So be. identification And it identify ready those therapy community that is in setting is where important of and important patients that we the line educate might for will benefit. the right and patients early are

patient So with to I our of our US. on the that continues side and core and the for in our gastroenterologist a expansion the be part of medical efforts, reach room the core commercial more in think penetration fact the steady population there's both affairs

Operator

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

Aspen Mori

for Geoff. on Aspen It's

on first pipeline, the on XXX. First

then development quickly plans as for to beza move walk the PBC, us or either as you And on you play? bezafibrate it monotherapy, well. how -- of through and as a combo as into purely that I do view of the Any quickly a that? If you something path NASH development in about you. and indications, maybe terms look or Thank kind PBC you're different the of view what prioritization there beyond thinking could NASH, in or

Jerry Durso

XXX. on First,

the I look I human think we as said this work first year. forward in to earlier,

that that too based on work also a path second think, indication. development mind and looking potential indications We of then asset a early to that looking It's definitive right except on might on… this and And we're towards with regulatory, indications. at the terms your good there get right where group potential forward question some in across scientific are looking the and be rationale, say at in rather to today of point at I open to considering doing the potential

Aspen Mori

of do it of to any a see path was just develop where combo monotherapy? wanted forward regardless give On bezafibrate, if how play or I as a the you you asset? there you just beza kind understand Is more of munition

Jerry Durso

primary At as this of focus fixed the combination on has a combination. dose bezafibrate OCA point, our been and

Operator

Our comes next Olson from Oppenheimer. question with Jay

Jay Olson

US and I US Thank in like if the license do achieving you. business geography. path becoming US to a visibility a US financial margins had OCA, question, Can become looking profitability NASH at the opportunity a lower How ex alone Intercept into I'm out for the your you or starts about OCA? given have lower only focused And and on profitability curious to much US. consider US PBC and would you revenues operating ex PBC profitable rights alone?

Sandip Kapadia

term on alone we've the past is We're stand we business a Ocaliva marketing in is today expenses the that expenses. pleased guidance And you years, gives respect the profitability, and of least something in think long franchise is I direct you have outside business. the several both and US the what we expenses. our it's operating US PBC have consider and With the the commented profitable profitable, managed with think franchise to a where our expect sense past provided we selling at as accordingly. I over when a of sales how revenues that our kind grown

stage. burn As at as guidance we far as on see, we year provided, can context. last to least lowered meaningfully based But the compared you that this can go at hopefully, cash some that's gives our it's you that

Operator

Matthew Capital. comes question BMO next from with Luchini Our

Matthew Luchini

NASH, alignment with but to responded, it response now alignment get to a better on seems as you relates XXX so of it FDA, like try still guys so a actually, the with question, year So work this Intercept course, have to of European is, delayed bit in the FDA to progress.

we think relates the then to from NISS. it PBC secondarily, how EU here. opportunity So quickly about And on just wondering the should just as

so large, done Do resolved like Thank near given Just term, label relatively everything pulls related is in you've home the in in hammering discussion the that you FDA you're should to be you things it very and the and much. phase? out the and so the still so sort are much and other relatively far. any push expecting of be issues with we open feel stretch to or

Jerry Durso

take the I'll Matthew. first, Maybe second one

the is say So ongoing. continued process as to I've

we're facets all these of we're for interactions But And of regulations kind the again, months. in the is within is on could of though process. to the timing the completed be updates I to definitive ongoing. process obviously, that be would finalize not control coming it can't think working based really on the I say ongoing. is I since process What the the the label.

The was submit on Europe. the OCA The first on to We file. XXX. responses question is did day

of that be on can resubmission this year. potential a parallel, take. the prior you best parallel go and work in process to through And end for alignment processes working as ongoing in as important considering we'll are imagine, the We the those options we US by to the in

through process the are progressing We forward. and in constructive moving anticipate we would dialog Europe,

being assess a OCI course, on through side, as Of and working as that the things we'll European reviewed process, also first it NASH but drug reminder, the we're is progresses.

Operator

Our final from Riley. comes Mayank question with B. Mamtani

Sahil Kazmi

and context and in of similar in And reflected from guidance? the the EU enrollment on sales there Genfit, for the is question Maybe label how process on PBC and the about you. Simba Mayank. guidance how progress. taking going then of quick on the on programs, maybe, you Sahil Thanks And is Could you that's perhaps some change. the well? think underway overall provided discuss finally, a that label competitive the in in questions Thank a our as for This update congrats today. in

Jerry Durso

on So Sandip, maybe guidance. want you the framing start around the to

Sandip Kapadia

get is impact a more to so to greater new of One we've gave, is reflects I factors Obviously, we top as reflects information. million, that starts bottom to start range some population, I COVID best pandemic, while that lower about into the overall. I on still couple guidance as the million year. of the sort would changes. talked lesser the piece Jerry the advanced in we the And different of as patient throughout it's overall. about We'll it's based anticipate hard that other think see way on to $XXX say think, end also we prescriber so And the impact factored continue year PBC this what play, say also we you end think at in of specifically. restriction would we've I the contemplated to think the label refine the $XXX reflects the guidance the go

gives So maybe, that. hopefully, context on that And you a little Jerry?

Jerry Durso

question second the And was…

Sahil Kazmi

underway similar the of is in well? there EU in process label as -- a terms Just update

Jerry Durso

So per process similar a se. not

of that is the the in NISS know, was the out you the from ongoing now FDA. context initiated As process marketing right post

US, as regulators we things to there look with consider the that course through Of work discussions process. FDA the about NISS is with will but a specific specific the we right the speak I to process the

Operator

Durso turn question-and-answer session. back the to I'd closing concludes Jerry remarks. like call to for That our

Jerry Durso

So thanks continuing the to for questions forward dialog. the look and

our strong I new major achieve advance us near for And evidence as our NASH, we've that today, and my our the end diseases, on serious OCA mission. outlined about definitely capabilities have spoke to ability objectives which to and PBC, pathways Intercept's XX to grow and this excited multiple liver success have with company. our with I'm year think, business, other of generated execution patients we gives looking the to CEO, and the forward I the opportunity our first the importantly, we days as our our support people transform

you very So thank forward conversation. And morning. continuing for look the joining us much to I this

Operator

Ladies Thank and you this today's call. gentlemen, conference participating. for concludes

now You may disconnect.

Intercept Pharmaceuticals (ICPT) 25 Feb 212020 Q4 Earnings call transcript