ICPT - Earnings call transcript Q3 2019 | Intercept Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen, and thank you for joining the Intercept Pharmaceuticals Third Quarter 2019 Financial Results Conference Call. All participants are now in the listen-only mode.

Following opening remarks, Intercept’s management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request and a webcast of this call will be archived on the company's website for approximately two weeks.

I would now like to introduce Lisa DeFrancesco, Vice President, Investor Relations. ahead. go Please

Lisa DeFrancesco

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

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

statements, this as the of uncertain forward-looking on such law. Listeners to assumptions are risks cautioned statements and not call statements inherently to by based subject place be reasonable obligation speak forward-looking except date of which to uncertainties. number of undue These a are are and undertake these that to we no reliance required update and although believed and as only estimates on

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

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

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

Mark Pruzanski

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

to the quarter drug who me approved advanced suffering submission FDA. Intercept from our for to for patients of NASH the extraordinary therapies fibrosis an first application of historic new the unfortunately of is to my summary achievement due noting accomplishment Let no available milestone for begin them. and by many have the a with the This NASH,

personally September, our our the We filing I'd authorization with in with our later our their anticipated public resulted in remain submission to thank application tireless team or in quarter. consistent on that an guidance. efforts EU like track for this marketing with MAA

of experience development to launch. first-ever ensuring the on addition the progressive filings, of continued of for commercial placebo-controlled fibrosis than be have treatment trials diseases, In execution Intercept agonist OCA With therapies with regulatory remains laser effective therapeutic II be benefit with NASH the our crucial novel to that liver the only to we've focused due readiness on III years of for company treat more to in anti-fibrotic the our large NASH. to first-in-class Phase XX a focused believe non-viral to FXR demonstrated we advanced and patients

remain we first-approved the indications and effective leader and positioned on are marathon, proven for with space, these again, Developing the continued NASH simply in the shortcuts. no for success a a well not time there new therapy horizon. anticipated is As we've this treatments sprint,

foundation NASH, priority execute early us of as FDA We to successful business worldwide, a which OCA grants review launch our within be PBC globally. our confidence great have are in and on standing in the XXXX. the fortunate and of as building we've approval, position success could liver on provided strong be commercial first-to-market in established Based the community ongoing spring the we of our ability to built

continued commercial our year to the the demand globally. on our quarter, execution strong We've continued I business in mentioned and solid prior based growth to of pleased out I'm steady PBC see point momentum organization versus worldwide.

increased now our we've to performance sales our $XXX between and year XXXX million. for date, net $XXX full Given Ocaliva million guidance to

for positions patients have established uniquely with medical due NASH. commercial to PBC NASH, to advanced of success fibrosis the strong patients. hepatologists gained treating our believe many supporting prescribing business infrastructure and We We've already valuable in whom gastroenterologists, specialists with experience developed and PBC us the relationships Ocaliva

As flexing stated, our within capabilities, preparation are on community we in while the launch. our infrastructure existing up we've building previously our for and relationships NASH

is with Following in to advanced OCA the its approval, to therapy patients NASH. fibrosis become anticipated due foundational positioned

which therapy advantage. physicians, all benefit, with with payers stakeholders will anti-fibrotic shortly. We have importance underscoring more believe of continue the robust to what groups, we be to a a in discuss Jerry and productive These interactions patient recognize detail key critical OCA's

to for the the want XX of will a Association meeting, spend the diseases, time the American presence discussing where now pivot Meeting study and in general some we the have and than Liver Annual presented abstracts I liver significant late-breaker AASLD more sessions. being of upcoming and

excited we're presentations Our posters at liver dedicated hepatology and the our showcased in be will about team meeting. is to that community the the and customers

highlights, OCA's benefit patients phase, from findings therapeutic on X-year in on for years. treatment with side, up the results demonstrating durable III open-label PBC new Some no we're presenting poised PBC Phase the to final safety six our long-term

in are across have the which There reinforces patient-reported patient outcome that from of PRO that On benefit important the disease. consistent is effective asymptomatic population scores. or fibrosis two side, of that also REGENERATE, provides with an NASH treatment abstracts the broader demonstrating the population. OCA indicating oral REGENERATE life expanded anti-fibrotic that NASH intent-to-treat norms, one can we'll PRO are scores And interim presentation the results an analysis population, not established below including quality improve substantially patient-reported

NASH tests used by that first non-invasive of in patients. physicians assessing We on important an are OCA's also their NITs most effect presentation commonly have

an transient of at important to coming before, said at will and meeting week in the NITs, fibrosis data including, ability specifically scan our early fibrosis. we've liver The consistent launch. elastography, in showcase As we ahead new improvement of acceptance measure growing believe of improvements time there assessed that be correlated staging number we presented the the clear liver for of for believe a of therapeutics a in diagnosis due OCA's is time We'll NASH. ever expected medical NITs the with this in and are first community a to drive stiffness fiber trial,

further care liver robust evolves. the to really and noninvasive nature invasive Given see move we encouraging the expensive the adoption of III believe these Phase biopsy, the interim and of to REGENERATE of embrace from noninvasive tests it's and pathway such biopsy NASH the validation NASH studies the field data to as analysis alternatives will accelerate as well-controlled

NASH development enrollment of REGENERATE, the of the close the ongoing continues clinical and III Our of cohort to of of compensated in NASH enrollment outcomes New with ongoing. cirrhosis, patients of the randomization expected We're study program track to Phase the finish progress to with currently patients III our continue with randomized such Year. in to only toward early X,XXX completion REVERSE, month Phase completion screening drive on well, with trial this completion we

align the the to expanding endpoint improvement in primary of OCA As REGENERATE. worsening target the is phase the approximately REVERSE of no study NASH, we endpoint we And plus to a REVERSE extending with enrollment fibrosis to XXX up with patients, achieved announced to were identical in XX last REGENERATE. months reminder, to double-blind quarter, in

by OCA compensated NASH to cirrhosis. successful patients reaffirmed to the expect of we recently with FDA, indication a REVERSE treatment support readout the of of As expanding

In to against you in we've development progress the summary, our approach and we're update XXXX. pleased commercial year-end, on as objectives important we made

indication. We year launch years three expect of we this net orphan after in end will Ocaliva our $X.XX billion approximately with sales just

much XX is a PBC successful reminder, need, a approved more approval in in market rare therapies of therapy with developed like than a As new regulatory approvals where patients the countries in a liver was Ocaliva. NASH to territory the and prior PBC market It have years to is no today. been XX have uncharted been to-date. novel We've disease delivering thoughtfully in

upcoming our we are NASH filing, With this do NDA and to NASH. uniquely positioned again submission in recent MAA

the foundation accomplishments and positions the While Intercept specialist amazing for the we now market community worldwide, our NASH more strong. opportunity, of proud larger couldn't gastroenterologists' continued than much a our in I XXX believe of hepatologists success. more really be us represents team commercial

plan our research to on like NASH Event that our detail plans, to I launch additional on ability provide insights review Jerry, pricing turn shape and regarding Investor working progress in we OCA launch through an are of able host including will period. hard XX assured, respect it the Rest over December we confident Before I'd details board, such this to label made certain Monday, announce the areas, to feel these successfully provide ahead be see physician we to market and us, year. anticipated in with that There of and following and opportunities based regulatory NASH to-date commercial approval. as with across the our we're the patient anticipated details to at from that within about final U.S. some take course communities our our event, our to launch won't starting next thoughts and approval

Jerry turn to Global With and that, it I'll PPC NASH prelaunch for activities. an Jerry? our our Commercial update over business on

Jerry Durso

net we increase $XX.X demand. the quarter reflecting the we million and compared to Thanks, XXXX. in sequential and the prior In in over as quarter, $XX.X quarter approximately Ocaliva XX% growth sales, representing In reported of third achieved net the quarter sales an Mark, good third everyone. U.S., morning three, worldwide in XX% million of of representing growth year continued

Ocaliva number patient of performances region an initiations our particularly transform $XX.X Turning XXXX, to in We PBC in strong our national we third the region. representing reimbursements. of following of quarter, across increase that quarter of pleased the new ex-U.S. sales rapid management. the million key markets of XX% the We're net increase to teams to as continue the approximately third as compared international achieved reflecting launch

of remainder drive in we look XXXX, to PVC our in ahead confident to commercial momentum business. As abilities I'm the our

we with by payers NASH, we on significant preparations. make focused U.S., continue a defined continue the framework on launch working patients, to turning and In early Now our progress the make and to and than progress on staging rather This traditional of fibrosis tests we change to that noninvasive continue by of is the front. advanced supported disease. acceptance being growing the physicians',

due research, tests, patients were fibrosis and with most specialist without community-based imaging majority identified on including Based report our specialists they're of blood-based modalities biopsy. identifying using market under a the care patients the NASH, measurements. noninvasive comfortable to And that of

NASH patients. We these the important to tests expect management as the of continue tools of grow in to use

efficacy our encouraged data, OCA's have as also earlier. conviction by in demonstrating we Mark presented Medical AASLD We're the the at reinforce continues will be learned upcoming to What of option. that very patients thesis there meeting eager from treatment mentioned to to the due which without to NASH today, approved most advancement are patients goal urgent an Specialists treat with these cirrhosis. suffering preventing are many fibrosis advanced noninvasive

the that of suggests cirrhosis happen anticipated. can also previously data than New progression faster

cirrhosis to urgency progress in advanced These is just the ill in one in example, six can paramount. and For population, to critically the are XX fibrosis treat months. patients patients

Our patients market insights with indicate once these antifibrotic in and approved a target market. with clear an treat available the product to willingness profile OCA's therapy

patients tells Many about their data report these as risk to the to of just with NASH Our NASH and campaign, which that are an us very seeking with they're patients concerned information of education physicians quarter, patients the also focused the on that not and treat we urgency disease advanced progression Truth, fibrosis. is fibrosis launched the during majority unbranded disease. of advanced informing more is about

U.S. the Our progressing are the in conversation with payers well.

state of and fibrosis best the way We on advanced identify and and educate monitor them to disease treating to the patients. these importance the continue

FDA's of phase study guidance launch. proactive approval X Importantly, discussions continue with dialogue a we're regarding the through under sequential data we Phase payers REGENERATE from the and now as in our engaging

advanced and evolution a Payers have diagnose greatest the generally unmet need. driver value a resonates view OCA's benefit fibrosis noninvasive cirrhosis believe greater related benefit that the make use as top strong the continue communication recognize with Payers payers fibrosis. on proposition the priority. the also to demonstrated with the of prevention and based they methods with a this we'll to patients We advanced agree and complications of patients key value fibrosis of that towards

we field is also that U.S. happy the success complete our and team to have ensure at expansion to nearly our note the payer right capabilities of I'm the in launch.

ahead, look on fibrosis focused we As preparing due for patients with a to we're launch specialty advanced NASH.

XX,XXX approximately PBC today hepatologists territory in approximately Our We U.S. is with specialists cover target to about X,XXX these specialists the already GI XX business for of and managers. plan

field organization we sales Consistent sales our the time Intercept XXX majority in on increase flexibility. managers launch. managers to support to And up. approach territory by reach PBC, internal sales We're incremental identified and business to to additional approximately contract a the with the expect track deploy our personnel from have organization give we the we now to scale of us

host contract we'll educating every and team we're of while The Overall, has educational the maintaining completed completed a team last state trading our business, team of medical expansion launch. We've programs. PBC on and of been executing began strong first U.S. of well also affairs specialists our phase on the remain month. wave prepared our disease sales our ensuring focused for upcoming new

the believe fibrotic experience we leading successful Across region, areas. therapeutic across many a access and markets numerous within have first-to-market of engagement. to blockbuster in continue we is expertise in place market advance built direct as we've team this preparedness our approach deep in the and larger launch important with important broad have pharmaceutical the international in footprint Many on that sets. segment. thought We highlight skill and focus key launch the blockbuster It's a to leader drugs OCA has companies for opportunity this expertise

the very this with the we're forward December. and summarize, I feel team event to at sharing the the opportunity. of To ability to details progress our we've in about take launch built, advantage look I import confident making more

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

Sandip Kapadia

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

$XX during growth In third total positions the showing versus up the a to of for the $XX.X of year in XXXX solid the a recognized million XX% in quarter, XXXX. third quarter. we financial strong revenues, results us third quarter Our prior well quarter end million from

XX% net quarter Ocaliva of of U.S. prior sales quarter year third $XX.X and comprised versus ex-U.S. represents Our net This million. of sales a growth million sales net approximately and respectively. $XX.X of XX%

We see to continue in demand Ocaliva U.S. solid growth the

within orders reversal observed This expectations we during pharmacies as was from in our QX, we underlying a specialty and below our QX the prescription During trend observed of outlined growth. QX call.

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

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

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

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

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

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

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

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

QX to the in remainder for in strong the confident XXXX see and outlook Ocaliva. are We demand growth financial for expect of continued

$XXX million $XXX to $XXX million range As previously. and million increasing Mark net the between sales from XXXX mentioned million guidance earlier, Ocaliva we're our to $XXX

in to to $XXX previously. million adjusted We range. $XXX XX% from the to XXXX non-GAAP be now to operating We expect to million year expect to expenses gross-to-net the between $XXX be million continue million $XXX for the XX%

OCA also agreement uncumbered to our to announced have with and pleased recently the rights in We to mutual China full partnership Sumitomo a globally. terminate we're Dainippon

PBC our solid to business strong for continuing prepare advancing summary, investments of in momentum regulatory cash important launch progress filings our while good NASH. a are In have very in successful OCA in a to position we're making make

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

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

Operator

with comes Instructions] Fitzgerald. the Thank line you. Young of First question from [Operator Alethia Cantor

is line open. Your

Emma Nealon

investor that for Hi, and this assessments in is anticipate we Emma a to you and on what patient you frame give diagnose in should Alethia. information December being number expect Can help us just particular this at at whether time? position update

Mark Pruzanski

to to Yes. I'm Emma going give so Thanks. Jerry. that

Jerry Durso

Yeah.

forward market patient meeting see sizing date, target. segments the you about the going is look the on update think our it. to based I definitely that we we've all all in will how on the thinking how of of we're that and relative plan we to overall we should the anticipate December we'll our So to expect where these segments attack And data we and accumulated what

fibrosis the So I it on different advanced clarity market early us in approach Again we and think the the market to how context the over context overall towards time. commercial of for see about segments. that in in more thinking moving

Emma Nealon

provide comorbidities? also evolving progression? they're nonlinear can could just FX have you are to have NASH patients then that with how if around specifically receptive conversations And payers Okay. your with any whether fact on the color wondering, And fibrosis who

Jerry Durso

Yeah. Again with the discussions well. are progressing payers the

sequential now As discussion more started you -- depth a a lot dialogue. we're We on disease imagine into the around can of data. with and our it's state on the moving

accumulated with best do payers them. we're the of segment that that in are all the the defining in terms that real concerned how ones to the them, that recognize costs we're right to those about with frankly of window advanced cirrhosis in really now are looking patients at the where progression world. identify and And patients they're advanced of group The and complications

see challenges like the about how as that at the They progress more biopsy. some the these noninvasive payers stakeholders with patients of clearly exist other the best are thinking look also to and all recognize they diagnosis means towards of

Emma Nealon

Great.

December. the to in update Looking forward

Operator

Thank you.

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

open. Your line is

Brian Abrahams

on be an discussed whether what my and Thanks any for questions -- now filed the discussed potentially taking you wondering there? might just NDA FDA the key question. thoughts there. I'm I ADCOM much hold guess might with very updated Hi, had if

sort pent I NASH you're trajectory? of term wondering levels market research, Thanks. doing view demand an secondarily, initially what longer I'm uptake just on-the-ground the the what launch to be guess I sensing, relative up the for numbers how guys as indicative market. could your as of you are then overall And guess addressable in you early

Mark Pruzanski

Brian. Thanks Yeah. question. take I'll first the

insight any since additional to have possibility don't the we we an So of time last the ADCOM. talked about you

But, not. up preparing to hold will us course, to or they to it want We one FDA prudently whether be for are one. notify of

With respect it. to address to second ask I'll Jerry the question,

Jerry Durso

Yeah.

for all, opportunity mean, I population, of to stay launch. going launch. plan So thanks who initial this how we this GIs targeting. are to the we a that continue as most We're strong is phase the A for ones advanced significant that are focused who the and items, regarding which on treating a see likely segment on couple of additional question first focus clearly we think recognize HEPS important. I of think we're but I this we advanced the are

launch. We as of would about being timing think the payer in typical a of product terms specialty dynamic

through We patients specialists coverage sum using they'll So bury and under as a payer the an antifibrotic are to process, their some comfortable go today per the do a is that are care formulary that decisions know specialist there that are from of OCA which for. their payer. like

would their day scheduled of of large that typical to on like group therapy chronic one that presenting flow next at treatment visit as We are patients patients would opposed a be launch. more anticipate where a

about medication. and with we typical specialty So see chronic strong think what again a the you launch with

Brian Abrahams

Thank helpful. really That’s you.

Operator

of from the line Jefferies. next question with Michael comes our Yee And

is line open. Your

Michael Yee

for these the have Hey or that your remind all of precedence about a launch. I or you it of been other FDA whether would of your seems type any of And just a require guess, you've positive Can lack done the level made and around drugs that. biopsy view look payers you guys that liver guys, drugs? thanks. presumably, work need lot of forward comments biopsy confidence ever has a required any or us to

a up a consideration, is us precedent And ready patients NASH actually to be asked, see there remind was to that often lined that then that? follow-up Thanks. just can how And ready to for do or go? people what and there payers these it as question or you their is doctors, just is they'll relates

Mark Pruzanski

I'll Sure. start Mike.

stakeholder. invasive this are move as said with before, in I've we side, atypical to patients of a regulatory a that to they the respect authority label. highly need know diagnostic regulatory just attuned away to method staging the it's on of method as from certainly this to So any diagnosing And specify FDA, other

of studies I hepatitis the precedent. of Back there labels. viral certainly those done don't the biopsy the with is see in biopsy use not kind in of biopsy requirement when days you think or were any

Jerry payer can On the side, comment.

Jerry Durso

Mike the the Obviously, year to once these there's was think kind but patients. specialist some some which regarding of office. good your the some Yes. elements are in a frequency on with patients of variability I is a of twice depending guidance there, question upon the specific

to So, a been relatively basis these be their regular we under first of and ones patients care targeting gastroenterologists. are that recognized having would a disease that again anticipate have with progression the or as would be hepatologists on their

Mark Pruzanski

biopsy. Yes, and we've of the not that said before today out, under round to specialist received care Mike these majority just patients have it

elastography. certainly respect modalities week are remarks for example, transient my very FibroScan, and that blood in very about non-proprietary presented are tests we're imaging We I excited like non-invasive both tests the to hard being looking proprietary, next that data working the AASLD, at at prepared with referenced

that is clinical of the a of aware before the the said But biopsy, stakeholders the this progress. we've well that risk, not work practice. So, payers it's all expense, fact the variability, in in or are deficiencies day-to-day including standard-of-care

at. So, we're that's of kind where

Jerry Durso

that That's other is, about therapeutics available. thing of only the all we would I The Mike. presentation in when of course, the context add of patients. Yes talk these no

deal again available anticipate when a the that motivation do up we these to with drug there's patient finally. goes So,

Michael Yee

huge requirements there have is there not of good you? be a We very are bolus was that feel like possible point payers patients either if you biopsy that could do FDA. therefore or non-biopsy say by for My you that

Jerry Durso

as this -- patients do -- these one done recent group been in next are identified that of items. relatively but details are already. been We only are month of know And there not get will for and that the the that's already the have advanced, be patient things that a We of terms have sometimes there one path a treatment. more number with the I forward the is this tests it in know again, of specialists they of lacking on interesting time. and we'll physician some Again think into

Michael Yee

Got it. Thank you.

Operator

Thank you. our the And Baral comes next question Ritu from Cowen. with line of

open. Your line is

Ritu Baral

them? morning Good centers, further whether Thanks at Can centers. patients and the may you to I more Maybe ask hepatologists current guys. picked split at their on of will why their on mentioned NASH you be they're And question. targeting. and the between that taking who NASH XX,XXX percent for you be you and under granularity are wanted coverage? that clinicians about under gastros, give us NASH your community patients a what little advanced thoughts they coverage least

Mark Pruzanski

Yes.

that fall address the couple that's part see an percentages question I'll the probably that question first more a in in think item of So, of of weeks. from the terms and the part of the us I you'll second

When essentially we the talk of at community that relevance of in broad-based about the group GI specialists is that launch the all NASH XX,XXX specialist have the targets bulk and the again of group. hepatologists broad approximate

and It with has GI but said group vast inside are GI a of specialists flex we group that some thing is up NASH. the to the so already we is who treat physicians over as with have is or is, X,XXX been specialists of great the PBC get several we'll we of incremental capturing segments that XX,XXX. that the in get different dealing of Obviously, at part the so that the that, time larger core majority

data. quite of at bit looked a We've

approved NASH you there have data we're the treated at able As we prescription population to sets advanced those that of that since identify lot to but not imagine be been a any traditional first. there's data looking be expect in can haven't physicians interesting to therapies,

Ritu Baral

more Tier that -- NASH in Is patients like tier that first you targeting be excellence a of there within that advanced covers centers or specific X? you'll them are

Mark Pruzanski

the in in of subset those opinion that involved part a academic key be a some core will that. terms centers, centers obviously, there be cetera et the trials of are in the the Yes, leadership, will heavily of of groups clinical

audience of real which there patients where of practices there's then practices. volume large to those a the another important are the is overall And community-based size due busiest gastro

Ritu Baral

Great. Thanks for taking the questions.

Mark Pruzanski

Thanks Ritu.

Operator

you. Thank

question from Rahimi Yasmeen Roth is Capital with next Our Partners.

Your open. line is

Yasmeen Rahimi

for you taking thank team, question. the Hi

XX meeting first presentations. dominating So, on congrats the with liver

So, -- centered meeting. both the being my my at on data of presented are questions first the

one look the rates? So, of provide five on you did long-term color give us on changes us is you the event the first or over late-breaker years employees. five-year -- safety some and maybe at data Can on

Abstract inform one follow-up outcome XXXX. not regards And And in regards in important then how NASH? And regards timeline? you have to does for PBC, this data more penetration how in market only to set where COBALT? but to I then as are this COBALT we in is data as well then And

Mark Pruzanski

and up highlight data. X open-label data, This abstracts. do We trial excited about the this is obviously this the We a focusing in year. double-blind. our the XX to have I NASH completed AASLD important we're five-year to phase Thanks really POISE And long-term think it's data. PBC for extension thanks Sure. had Yas Phase really one-year PBC -- again and

feet. new we obviously of of to follow-up a in this tolerability patients you patients we've their favorable have a been remarks, mentioned see vote in up And I that comment long-term no tolerability specific extend of to to that, So, with mentioned. for can't we with treated And expect on long-term number safety exposed response as with except stable prepared six we got drug. patients do this note profile and that during my durable pruritus that have signals as majority therapeutic study measures years. to I nice

of to And guide drive data. It's line COBALT important our continue we on that both as for outcomes going as PBC going enroll. to rate. is event We're and that, NASH to important that we will And this which to study IV sides. premature continues track to and continue is read to in me in that respect on expect data in our and terms Phase profile for PBC therapy generating I the foundational when to differentiated ongoing confirmatory With we're fit outcomes in But really say clinical OCA, established to a second NASH. clinical is PBC believe the ultimately out.

you So, the meeting. all come the abstracts and at anyway encourage check out we to

Yasmeen Rahimi

And regards attract to question the XXXX. in then second is

in So after abstract OCA in OCA looked and before decompensation OCA rates era. mortality this with hepatic patients at PBC

what can So patients to era into do therefore And OCA be you look and And the done OCA-improving doing have plan you XXX if the in not actually specifically, And you were on analysis? OCA? calculate percentage effects should did so the direct when you after of that? we such rates. that we're see expecting taking mortality them

Mark Pruzanski

Yeah.

abstract. Ray about talking You're Kim's

been So the disease Very went looked not a of number C. a PBC lower risk OCA predicted in over to intercept based at was the fragile that the of dose narrow recommended patient was be what than mortality since abstract and advanced abstract. you has patients Ocaliva once large is three This would've most at this an years this and is starting the with the precisely week. of de-compensated appears disease. natural Child-Pugh history is And advanced interesting approved just most conclusion on that this ago been segment that cirrhosis B segment where at

with to associated want just that this cannot necessarily this conclusion of abstract is be I causally Now, Ocaliva. stress the

to certainly to I appears looking or with we But We'll with on any gone that down. plunging forward Kim to least, more treatment. collaborating have that. I data. mortality, know Ocaliva it's And do on of answer Ray around if – conclusion think, don't into question worth these were the it is know look your at so the which patients is don't the

Yasmeen Rahimi

Thank you.

Operator

you. Thank

question next with from Our Olson is Oppenheimer. Jay

open. line is Your

Jay Olson

for questions maybe treatment Thanks an NASH. And follow-up. between plan you abstracts. some PBC? to between then about taking abstract-exploring synergies one the also Can also and had two I Hey. ASLB of talk bezafibrate synergies those about molecules how the synergies question. have these and I you potential about leverage And There's in PBC. talk OCA in

Mark Pruzanski

the for Yeah. Jay. Thanks question,

line interesting. is patients. study last European second of show the It's the out you're an France. was he a then this Ocaliva UDCA, then year. second of on bezafibrate who in was on yeah, the So put who investigator line. put time what patients period to were referring Corpus published to And with that triplet or Chris therapy. is inadequate after lead second is intolerant abstract BEZURSO at either This looked of on cohort or And a And were

earlier of the anyway year just combo at it's look be would to the response you again proceed the predicted compounds. with therapy licensed a bezafibrate improves U.S. in and And as of of very fixed-dose So, very our clear the the combo and supports after data rationale beza. that this that substantially development OCA two we the combination

that, intend the for we've try said to in treatment it then First also and we PBC NASH. of

in combination again, So can robust that another be therapy we dataset that leveraged PBC. support think of it's the in

Jay Olson

of what new that publication on with And endpoints. histological therapy. you you OCA. related describing of OCA after patients my up treatment at six question data Great. treatment the with PBC impact then PBC at in these focuses AASLD with is on market? the benefits these of benefits Can a abstracts would long-term just the about And years have combined sort And years be It second looking after data talk PBC to patients entrants with publication competitive the of into recent to three of represent? in barrier what

Mark Pruzanski

we data and year this that we believe a data safety down this number presented it you're generating albeit differentiating continue controlled. and years benefit of after in last in second I the coupled Ocaliva's and and PBC wasn't with the commented on presented POISE efficacy we small those who's being at data And three a of long-term And outcomes Yeah. fibrosis data showed minutes baseline we focused hope meeting. of follow-up to new then a on data Sure. patients I irrespective Ocaliva underwent is we and publication and cement course, will the who be we line ago the patients referring biopsy subset that continue side. pike. mean, that to continue generate and of the exciting to with on couple And coming eventually, exciting positive position to

the NASH of interim on the the that -- my outcomes launch. we're charging path patients close the we're cohort REGENERATE data NDA outcomes on I to building very obviously in mentioned of But side. remarks in in readout interim completed randomized, post-marketing X,XXX on support thing down the exciting having analysis XX month Same and we for NASH.

So it's going the to few continue over next exciting being years.

Jay Olson

Great. Thanks again for taking the questions.

Mark Pruzanski

Thanks.

Operator

line And our next Salveen Sachs. from with of question the Goldman Richter comes

open. is line Your

Ross Weinreb

for Thanks Salveen. taking questions. Ross the for on is This

REGENERATE the call used to guys from the you be inform going is payer that X data noted to decision. Phase On the

the broader follow-up. OCA? this be Or to we initial more PRO that be part to the have of non-invasive of data part NIT of I is then, And should expecting be a should label? that and something a potential elucidate diagnostic the However, initiative

Mark Pruzanski

now, on week understand and to label. nuances be very are data. in specifics They're data Boston, Yes. and really presented of of going there to the definitely, think I on the what's right more do NIT But we these and the will mining data end implications in these comment, the up PRO important. next being follow-up can't lot publication to data, a

stakeholders, to I question, physicians, certainly with effort. cetera. going we're to more our part of to this various these think So your leverage data part And et broader payers, our of latter is going educational the be

Ross Weinreb

Great. And then, Sandip. for

the the demand thinking out be XQ play So trends, based we this on Q-over-Q reversal the how And underlying the here? how ordering about into quarter? fourth will in should change

Sandip Kapadia

through mean, even question. the period. Ross good we thanks summer the where a underlying Again, very saw I quarter demand solid for we obviously had Yes. growth

So we of growth as had in good continued international U.S. the contribution well.

pharmacy quarter, the of had underlying we see orders the last trends this which mentioned, we indicated. the U.S., saw and IMS in anticipated which quarter is specialty you what a below reversal As we did

increased guidance the we year. balance the of sales So our for

confidence. we I So continued have mean

I we're $XXX to growth But, growth, from seeing million. our million guidance trade quarter at see $XXX think, continued the at strong we're thus inventory sales potential least in demand -- we increased impact don't of range good we four. and any changes

Ross Weinreb

the questions. for Thanks Great.

Operator

Our next question comes from the line of Brian Skorney with Baird.

Your line is open.

Jack Allen

look taking Hi. we Brian. NASH. to should levers into in Thank Jack PBC you our we're as about potential down dialing the We is think questions. and your and Thank NASH discussion for what wondering in wanted And potential PBC you pricing around if XX-milligram the NASH? pricing in two for This ability in to to FDA differential in implement And potentially implement dose indications? approval effect of differential pricing you. has potentially drill the the any

Jerry Durso

the Okay. Thanks for question.

filed separate First, know, as we NDA. you a

brand, the we course, considers ultimately positioned gives And option maximizes launch of ourselves some which under us the optionality, different so, a plan NASH also long-term NASH pursue overall the is, to the pricing so to the franchise. of launch which and value

label this and the quite are clear Obviously, go point, process. the through some that not at as mentioned questions of we the you

are overall with the to important plan which we'll finalize at and into pricing continue really launch. the our payers, that So input communicate NASH in dialogue an approach The work. and the

Jack Allen

so Awesome. Thank you much.

Operator

Thank you.

from is question James. next Seedhouse Steve Our Raymond line of with the

line Your open. is

Steve Seedhouse

And the just discussion. Yeah. just, to you. the the I based regenerating discussing see mechanism some just ask on on get achieve gallstones wanted on different in comfort Thank the a on you're Good then, the morning. to gallstones. literature, thoughts what AdCom with of in thinking wanted I based potential and your risk could I your follow-up questions for you of to Is Europe? wanted issues opinion in to as you. just about and risk preparing U.S. arise, Thank and academic that easier indication-based you're and pricing also your that or

Jerry Durso

first Yes. I the take I'll part. guess

between regarding a have obviously, in it's a different the So And and Europe. different pricing, approach. the Europe U.S. markets system, different

So mechanisms in Europe be the will varied.

decision separate I U.S. in will own will independent, earlier. approach discussion have regarding used because the make criteria Some the completely work the and the to be take outlined We'll markets international will look it its it by a definition brand at that individual pricing their

Mark Pruzanski

respect to question to it mentioned and ultimately for of I at to is one, earlier your terms risk. AdCom. that overall go have focus AdCom, there safety I FDA efficacy if the we're that one. one interest to and preparing Yes. And benefit decides about if in With would across-the-board think, of

that population effective fibrosis. in dose to profile we're the of very obviously the the on Needless this seen confident based in benefit-risk with data we've OCA, all advanced the dose, say, XX-milligram favorable

You asked specifically about gallstones.

population FX gallstones the common real, manageable publication. was or imminently in something would proves of that dose. again, difference a that XX-milligram effect think reported and majority in to we we signal the a are To that be in there's It saw -- of patients. this plausible it's mechanism extent where but to you class probably patient gallstones this vast a patients, alluded OCA with the a numeric more And very in recent

view particular of benefit our our perspective from that So alter doesn't risk. signal

Steve Seedhouse

Thanks much. very

Mark Pruzanski

Thanks.

Operator

Needham And Alan of Thank & question our next you. with the line Carr comes from Company.

is open. line Your

Alan Carr

for thanks my taking question. Hi,

guess opportunity also invest that and could about go You expect talked in commercial potential into about if decisions sales also the contract the more infrastructure? sales person earlier force it amount XXX over a that in there force. and I relative Europe, you the you own the then Thanks. you And building that wonder your can to go building scale and but talk timing I around of that

Mark Pruzanski

thanks. Okay,

sorry, our have of doing out organization there As we month earlier group remarks, team last I first education. prepared sales mentioned contract implemented -- in the the that's

that model opportunity and our a sales keep a PBC part really of of while need a to It team sales contract we force for some we pulse overall gives It's been from group. our flexibility in a us when portion to. some

ultimately team think use launch. is look it's ramp effectively. XXX the way I levers will complement We'll about continue to how to group think to that the -- up different to that sales the we for internal a to the

forward per the the to and progressively as will move contract launch internal the as to adding both team We our through plan. group be we

Alan Carr

at details contract sales force the this that… the on No size point of specific

Mark Pruzanski

again the at some But from team the the details XXX on Yeah. and territory ultimately more sizing business that internal our We'll of Intercept it think when is come the way will that we effort event. of get managers. ramp-up give to of about process launch the approximately to majority

Alan Carr

for then Europe? And Okay.

Mark Pruzanski

Yeah.

take some the there will pricing around to So Europe there's look you Europe which and We'll mean the in time. plan of prevalence if at process European at I similar opportunity. the be potentially data advantage will our look investment patients reimbursement, market. the normal of in take numbers Obviously

milestone you a to also have basis on But different move timing. through

at market. nice market, as the that up the file first which based the front in and individual first process chronology the quarter right on then tackle the later so ramp the progressively. markets way Europe, look that But ready reimbursement market terms the will get obviously regulatory to significant in U.S. the we'll of opportunity in you we be exists in focus this First market-by-market to individual on

infrastructure consideration key important think I internal on it's the European build where we did as markets Europe one just launch. on important the PBC last the our the ERP. in And up thing,

and process flexing infrastructure So the U.S. talk same relationships markets. where of up teams with the with when there resources kind about stakeholders we real the like in an sound good, strong these with we start and key a

Alan Carr

what extent arrangements you or co-marketing in type Europe? licensing are To parts out to open of

Jerry Durso

in accelerate there's If patients very very We're like Yeah. access that that minded we're minded that Alan strategic to we've a open respect options. can open before said with possibility. need. to company to

Alan Carr

taking Great. questions. my Thanks for

Jerry Durso

Thanks Alan.

Operator

you. Thank

Our next Securities. with Bayko Liisa question is JMP from

is open. line Your

Liisa Bayko

just point to more noninvasive really pretty either your probe guess or on at little in see bit they wanting use payers, they he a are this pricing the not comfortable on with mean, my questions approaches? terms are answered, a majority of but have of to but where biopsy. thanks. biopsy, been with I of Hi, discussions The at I

Mark Pruzanski

indicating, for to the mean, the biopsy. the believe I in the been fibrotic the diagnose as challenges question. I given think all advanced world best frankly we've are Thanks Okay. we NITs patient real around way

for the liver about had from they're fibrosis that disease. learnings payers, I are the conversations well aware and obviously assessing think think NITs we the and available if we've of

payer C the in to clearly approach on side thanks NITs hepatitis of large their payers. a in the where many Partially consistent is the experience rather of use

as the in all imagine payers. middle We're So we with the now. you can continue, see of the market those But this discussions in momentum overall of encouraging. momentum continue is the

evident key in large also the dataset's going discussions. that those It's be to REGENERATE

will the it's really to specific at be them. the the data and OCA that of an great Boston see in overall so emerge with week NIT that begins And meeting dialogue to to next important part

patients advanced fact And when are the setting another more the the clearly so in that important what today. And time concerned again identified about KOLs launch. they're this we dimension opinion is going and is are understand payer leaders of emerging the practice already I most are and think they're through there's primarily group This means to noninvasive looking payers that the that be think that course, behind. all being of between about key saying data the to dialogue also, now

Liisa Bayko

Thank you.

Mark Pruzanski

Thanks, Liisa.

Operator

Joel Thank with from next our question you. Citi. And Beatty is

open. is Your line

Joel Beatty

Hi, for the taking thanks question.

until other on being there'll upon realize one results the for the seems first OCA on based expected no whether be be you The FX would in labeling the come, initial but treat discuss fibrosis could patients? is, could REVERSE to And NASH fibrosis? you it the like secondly provide stage? potential any that's with then still to thoughts alternatives I patients next study, use approval year studied those those

Jerry Durso

Yes.

on And label. So we're wouldn't comment out again question, in stage-specific where to the our fibrosis. we'll with designation up But to see. breakthrough your patients end with respect indication. is point I'd NASH a that in necessarily we going exactly Can't anticipate first

It's with ongoing my I need. such right III think in market population Phase I that's separate a I prepared REVERSE. important the the mean a post-launch highest only very We and of unmet FXs remarks it mentioned REVERSE of patients. study is segment in study is the now.

use a in think in a support segment the of positive positive of of segment the launch an the phase expansion be it. we initial targeting. indicated would result that And this and differentiate this drug the that population in But in outcome the further study again study of is not will I

Joel Beatty

Thank you.

Operator

our Wells Thank with Birchenough question of the line is you. from next And Jim Fargo.

open. Your line is

Jim Birchenough

in me fitting avoid, and try for I couple Thanks questions. but guys. to a Hey of as it, pause

market behind. the drivers And you where versus speak it's further Europe If can could are then what what segments forward? the Mark share-wise, follow-up. expansion missing where that I've territory Europe at going U.S.? territories got versus to growth now think maybe Ocaliva, market on to? If you it's of tell share maybe in us expansion we're And you U.S. you right U.S., we're Just a then for get in are

Mark Pruzanski

I Sure. mean -- Jim. thanks

So on in momentum as look world. with said continued the thrilled to comment the ask business Jerry our call specifics. I'll around we the we're the in

Jerry Durso

a items. Yes. couple I guess of

throughout, or in the we've to community-based appropriate physicians for only group once the one market. information. see We larger two good get physician willing have the patients patients may continue As who mentioned three that GI GI we they a expanded PBC or is we've reach broader see the still prescribe U.S. those underlying into as demand of

continued we do a see to So opportunity expand.

don't also that patients eligible I markets, received in it to -- important. are for frankly think of it's majority there yet. out OCA treatment haven't according our all second-line The

still is just there organic strong opportunity. So a

good launch into good I happening launched the see in but see in phase prospects growth encouraged the markets, international solid that later, what's we did see prepared markets we in reference continue. to are -- remarks really we many of those a where we so earlier the

markets. yes is European then the as there And opportunities expanded we've beyond classic

think the forward. still standpoint early leverage appropriate I So in we a we'll see volume and move look way that to PBC you from as relatively opportunity in frankly it. We're

Mark Pruzanski

getting line. I'd are more adherence and than drug. better improve. first add encouraging the thing what's Ocaliva is with is with see only experience that to long-term that, The Jim rates valuable We've also really continue physicians to adherence got And more the

positive Ocaliva be who'll So are the of drug. group those And with most experience the who vast a physicians prescribing have earlier, experience Jerry said for core the as majority these the again prescribing NASH. have

Jim Birchenough

on just predicted of ability patients you from those have evidence REGENERATE maybe trying to the REVERSE value the REGENERATE just Could you on were for testing. numbers I'm to maybe or specificity. predicted testing speak noninvasive patients and understand to noninvasive that value, then those positive the support in of If negative discern testing. And of the strength eligible noninvasive ineligible? sensitivity

the noninvasive testing Just strength trying of understand data? to

Mark Pruzanski

Gilead actually Yes. STELLAR in and It's really strong own the publication studies. our happy from that the to mining exactly based X -- dataset the done right and question. And in say recent I'm data our on we've

elastography, sequential technique. robust So out and use these standard physicians You tests two when transient, things in commonly like ultrasound-based there all used serologic tests noninvasive see tests specificity also to can together, are sensitivity you right? growing that including particularly that are pretty available use

are discern other with identify tests in -- fibrosis these physician and from And help standard to identify addition bottom very are to cirrhotic to confident advanced helpful be to work-up -- that so do a also we accurate a patients distinguish would line enough patient. the and

Jim Birchenough

Great. Thanks for taking the question.

Mark Pruzanski

Thanks Jim.

Operator

from final And our question UBS. comes of line Jacob the Navin with

Your line is open.

Navin Jacob

the taking me hear for question. thanks you Hi, Can okay?

Mark Pruzanski

Yes.

Navin Jacob

Great. Okay.

any so thinking NASH? and Any line also dynamics to the of it forth? should COGS XXXX kind relates XXXX, of if into as thinking all ramp launch sales hopeful you going your your associated maybe of you expenses should about we with we be us Sandip understand And or be -- color for BG on force, some expenses rates about? how as so other on impending the item marketing help tax just So could and

Sandip Kapadia

the for Thanks question. Sure.

in build obviously say it's But the Jerry can give through we infrastructure mean as early look large I -- think what through the part a We'll the to terms bit this do that completed a organization. as later I point. year I going MEPCO guidance we've is, -- we're at organization, XXXX. of payer of mentioned, a

You as can a of it. has spend result our increased see

of the to we investment year. gives key The education for -- hopefully along the say I'd be provide is get investment the probably as next as in our internal -- would required as year, continue we'll this with next about closer we that Certainly greater get clarity probably year. resources we for as certainly part some additional key the sales force next force year expansion, And which But something. you to market. either think expansion, we get later additional towards sales

Lisa DeFrancesco

Okay.

Mark Pruzanski

Thanks very much.

We've it of year think week. I we'll We in great NASH later overtime, operator, next we've forward you bit a this dialing a driving run had year for towards Boston and so everyone many far. see look call a little there. in. so to Thanks launch

Operator

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

disconnect. You may now

Intercept Pharmaceuticals (ICPT) 5 Nov 192019 Q3 Earnings call transcript