Intercept Pharmaceuticals (ICPT) 28 Feb 192018 Q4 Earnings call transcript

Company Profile

Participants

Mark Vignola	Executive Director, Corporate Development and IR
Dr. Mark Pruzanski	CEO
Jerry Durso	COO
Sandip Kapadia	CFO
Michael Yee	Jefferies
Brian Abrahams	RBC Capital Markets
Alethia Young	Cantor Fitzgerald
Ritu Baral	Cowen
Steven Seedhouse	Raymond James
Ross Weinreb	Goldman Sachs
Trevor Brown	Baird
Jay Olson	Oppenheimer
Yasmeen Rahimi	Roth Capital Partners
Michael Morabito	Credit Suisse

Call transcript

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Operator

Good morning, ladies and gentlemen. And thank you for joining the Intercept Pharmaceuticals Fourth Quarter and Full Year 2018 Financial Results Conference Call. All participants are now in listen-only mode.

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

Mark Vignola

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

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

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

other this approved that OCA that can concerning be any In Officer; Today's conclusions of remarks to investigational We’ll will is time. from indication than call Dr. PBC. Kapadia. by OCA Mark been with or not safety regulatory has note our addition, your any Chief take drawn the for from Financial our please by any Sandip Pruzanski product No Chief indication call an authority begin other for the and followed Durso, our at Operating CEO, questions. open then Jerry Officer; efficacy those

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

Dr. Mark Pruzanski

call. today joining everyone. our year quarter fourth Thanks, full good Thank conference you and morning and us XXXX for Mark, all on

we've population leading our received OCA. from investigational study from feedback in in additional that the recap worsening the that safety study the observed pre-specified patients to be experts dose released news field approximately for the histologic and no histologic study relevant for support REGENERATE the two like meaningful Phase other to many safety course the week thrilled primary and XXXX, the patients with underscoring I'd milligrams a based last the of in adverse of milestone improvement most briefly to X we at liver OCA events as report XX-month once designed studies to in FDA in providing therapy. FLINT, Fibrosis has supported reminder with a and endpoint XX moderate approval. start important that one response cohort, either primary exciting OCA’s as EASL in in daily close met critically of population. and success with we one with regulatory our We X severity, positive in that fibrosis stage fact meet improvement NASH, analysis in are. tolerability with clinically view conducted seven-fold ever REGENERATE is trial predict liver the been last other This and on generally of OCA the placebo were how Before read and consistent at endpoint, most apart to we’ve requirement was the existing to of liver-related of study in out the to profile anti-fibrotic fibrosis to the a presented with receiving this We shown by of placebo will and twice results multiple least REGENERATE common the show XX X.XXXX. clinical the patients unequivocally outcomes, alone enthusiastic milligrams We XX.X% mild largest endpoints than close of positive is achieving supports on OCA’s This readout OCA the NASH NASH agent investigational as any analyses the and Since were and highly on first similar opinion see in week, result comprehensive known any were who all-cause gratifying the with with only largest patients generated safety, NASH on to fibrosis first approximately sets adverse of of share mortality. Phase Recapping, given forums. external value an compared results due data, topline reported off NASH. an efficacy a this, with database to endpoint with larger this NASH, statistically in most XX.X% us patients an X,XXX advanced us P significant of treatment patients a NASH, intent-to-treat basis, Further of consultation to drug. number profile to

upcoming and from journal. line we're to have in publication and in at results Following April medical of U.S. also study the expeditiously EASL regulatory meeting more reinforced these week, Meanwhile, our we safety preparing presenting results detailed to submit forward moving trial the generate the we’ve our in half major second intend We're continued top which recorded a looking to in this confidence profile. year. to last really European filings, and the OCA in outputs

designation OCA's our in NASH confident FDA prospects expedited fibrosis, breakthrough Given therapy we're review. in for

represents and reason a success the become critical the ahead. have XXXX, as rapidly suffer liver of the be leading patients of and all the with excited to of be watershed by execution thrilled which the everything that in NASH that from we the to to established cause backbone a the As incidence increasing continues globally. it's this first to remember with accomplished -- energize of hepatocellular more operational the indication. bring treatment potential concerning on success therapy important to failure worldwide. us for very NASH Stepping behind cause we I'm become We carcinoma be path the look for us currently a patients proved ever year year available disease moment to antifibrotic be to that's therapeutic remains REGENERATE to we back, That options couldn't in a done, to no who contemplate that work the leading

Over our franchise. significant of and the on course on progress of our growing program objectives, PBC XXXX, primary clinical course, we made business development delivering NASH our

trial in topline to side, On targeting completion work addition in in results the to continues and trial REVERSE the the deliver year. patients. well, by our the This we REGENERATE, of cirrhotic to the enrollment enroll of also announced NASH we end are compensated

NASH and support and for cirrhosis, which safety, pharmacodynamics regulatory studies additional completed will our further fibrosis also in We pharmacokinetic, filing. provide

for this with Turning with the announced we sales PBC our announced net revenue. were line to $XXX.X in XXXX business. previously guidance net Earlier that our million morning, Ocaliva worldwide in

And Operating Ocaliva Following net pleased label We our a in to bezafibrate, of excited to REGENERATE I'll our top turn XXXX on Officer, the intend expanded I agonist. we're a growth million bezafibrate markets and study Jerry With positive U.S. Durso, couldn't our February with we solid to to our announce commercialization PBC update. Intercept's in commercial successfully liver drive combination next diseases driven growth. our commercial over and performance and the other to efforts continued landmark it today, development as about results. further the PBC global course, by access update be These Chief year, that, in million. chapter. market force between embark quarter, to U.S. sales in in we internationally. and the strengthened of line initiate more and this coming across Ocaliva summary, expectations with Ocaliva's $XXX follow. sales a pan-PPAR for off Ocaliva have XXXX, $XXX rights our fourth the with our approved In guidance for XXXX, we soon future of pipeline In efforts acquiring

Jerry Durso

Thanks a good everyone. lot, and Mark, morning,

PBC. new our just list clinical year good a hepatology over quarter which position over a as physicians. launch the that for as pricing with ACG, we're we our period net time of community-based PBC treatment XX% the growth the for of intent encouraged and full Let we've We medical our and prescribers societies first same and of In saying the sales second commercial growth and our net only worldwide last strong specific uptake the efforts. AASLD key coverage pleased worldwide year. XX% to uptake gastroenterology in This of XX% performance me about both line and resulted also reimbursement, the therapy documents we year, with markets national expanded more last had and driven from We're sales on our by of XXXX past of growth made changes the see secure solidified start recent four by sales from the model target approved of continued for considerable gastroenterologists. with in by result our the leading Ocaliva the prior. increased U.S., versus publication Ocaliva covering year the and was in guidance enrollments which Internationally, of more our by

international we're achieving. with the pleased sales So, that we're growth

Looking at and that good expect we sales global growth this our XXXX, year. opportunity in see have the we PBC to confidence

we're and very from and launch with about turning to very execution. active our topline Clearly, planning So, now our data NASH. enthusiastic we're REGENERATE the

with While to the with we as NASH due there are of of advanced continue risk greatest at developing are is liver-related those need complications. patients they greatest patients believe to NASH, fibrosis millions unmet severe

through significant part plan, that This a payers. fibrosis and of substantial speaking our and NASH X,XXX, As market and outcomes. conducted to desire research confirms research well we've diagnosis, as of care hepatologists from and body with qualitative physicians physicians treatment of over staging, lens, as amount gastroenterologists a primary ongoing quantitative think endocrinologist, most of market

on of to for been One critical mortality fibrosis halting liver is unmet need see greatest are liver in endpoint fibrosis as surrogate in clearly outcomes also costs. patients, the priorities and more health predicting patients. physicians the impact has focused linked these a critical Payers preventing on outcomes progression care and NASH severe as potential the in NASH they severe as fibrosis as of the largest

the patients that line both NASH feedback encouraged effect and Given the by that that on fibrosis that potential to the which positive a reinforced our we belief physicians. support by the OCA data on meaningful will REGENERATE from top be that received for REGENERATE, on the has saw treatment key their we experts meet data. needs the has successful Overall, we're of OCA been of extremely

plan hand, X Now, OCA Phase our with for in steam be to NASH. preparations data in and market refining we ahead, context the REGENERATE executing in view launch full our of continue our

as customer serve will built receiving that that Our patients to quantitative us physicians NASH. Many to for to biopsy. of on we a the majority majority our to-date since specialists without the way launch under core prepare market significant hepatologists similar care leveraging currently research and gastroenterologists, We've we their base care of these the we approval. GI diagnosed called see of in advanced data and that insights of population -- in NASH fibrosis the are in specialist found OCA REGENERATE the that credibility were and hepatologists following NASH, and and as diagnosed those majority XXXX, saw today liver commercialization of and patients of with the physicians and that we're tells currently due these we've

base. to payer we NASH plan. to our as cover Now, and expand and field consistent move we’ll larger customer continue the we’ll how scale with teams accelerate We've marketing built forward, our the options ramp-up, also for in our medical,

state exciting that, local our disease I'll and is data over on questions the successful sharing to It’s colleagues additional an forward an and look are regulation insights the medical address course, U.S. to to with based a ready launch our consistent REGENERATE REGENERATE and as requirements. important progress. on education clearly With you in time update. medical our with the turn and efforts Of reactively readout for trained across and line financial component Europe, following Sandip the and call plans top Sandip? we of

Sandip Kapadia

closed in well coverage Thank you, everyone. quarter to see announced operating in The quarter for XXXX our disciplined sales We in a we began the Ocaliva previously a of rights to a of for key U.S. achieved the Jerry, with With focus our net impact issued guidance. fourth driving strong pipeline XXXX force our and Please was the with acquisition program good as summary XX, continued and the international growth press expenses, of expansion and release of in year December the development the ended the our respect sales of PBC full approach broadened today morning, full-year commercialization to quarter on PBC within our launch. organizational successful the for markets. We’ve license XXXX. fourth bezafibrate we our results refer our to advancing as supporting detailed financial as the business earlier U.S. our sales and NASH our a priorities with

just that over end upper ended coming transaction, the As guidance of expense the expenses range. a up non-GAAP of in operating adjusted result our

$XXX of We same $XX.X more the recognized and from we $XX.Xmillion as year into on in for with PBC as to balance up quarter $XXX.X the execute cash total the also details. fourth continued to and momentum year strong the for our NASH in million closed million as a revenues preparations. periods build million full well and We Getting XXXX, launch XXXX.

sales or the and million. U.S. in Ocaliva net XXXX. QX $XX.X For XXX% comprised a of sales sales ex-U.S. the U.S. of growth net as to of the XX% represents fourth quarter, net $XX.X and ex-U.S. million This of growth compared approximately

net represents of Ocaliva ex-U.S. the XX% ex-U.S. of to net of were XXXX. million were Our net deductions and $XXX.X sales sales full net the previously communicated Gross This and $XX growth XXX% as year sales XX% for within year U.S. the or range. to U.S. comprised to in million. compared our XX%

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

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

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

the for Our and an labeling This were year costs of and million of quarter full million over primarily of year and sales was sales $X.X Costs and of XXXX $X.X consist expenses. million, the increase prior packaging periods. $X.X respectively. $X million

The year SG&A a was million decrease administrative the expenses and million decrease was to million, quarter general our the were and year and of expenses. selling, by our periods. over streamline million respectively. prior efforts This $XX.X driven and Our for fourth $XX full $XX.X $XXX.X primarily

our full million development cash and and And million an year research respectively. with and U.S. $XX.X on for acquisition license. fourth primarily by the $XX.X million prior XXXX of increase was year and expenses connection over in moving was the driven of This increase periods. bezafibrate made Our to $X million, payment The million were $XXX.X the the $X.X quarter position.

efforts the as cash, to NASH a phase to patients XXXX, cash to our in with and financial efforts. and for business, into continue we'll year million to guidance. executing momentum as million. Once development REVERSE Given deploying trial our build launch launch NASH preparation. our for and the a our $XXX will be the disciplined moves approximately our on resources, to now and taking performance while equivalents patients. continues focused enroll need strong XXXX NASH approach outcomes securities resources to be And enroll on investing we U.S. $XXX.X again, year We'll filing continues continue Europe, our and we invest programs in in ended BXC to the our while support investable NASH clinical REGENERATE of with and critical the moving also our

million. We expect XX% sales growth -- over net $XXX a the represents range $XXX range for XXXX of This in Ocaliva to of worldwide million XX% to XXXX.

XX% gross of in to to towards the XXXX. to the of We continue expect XX% net and range upper the end in QX range

expect filing and million We the preparation operating non-GAAP inclusive of million, activities. $XXX adjusted in expenses $XXX the range of to launch

approximately amortization $XX to interest We expense of notes, and includes portion related our also which cash outstanding the million component. expect convertible

us to softness of of activities coverage remind planned moment our XX, PBC our in we believe XXXX to balance our which for in for puts in the launch in by deliver business as in like expected of further GAAP December gross U.S. $XXX.X the increase I’d plans position on to of cash the the first executing be take net, to manufacturers’ a As reset. you a quarter XXXX. XXXX result, typically a strong while continue QX insurance million impacted XXXX. as for will to responsibility an increase We preparation

of Although the net of first XXXX, fourth slight we as to in sales QX XXXX. during compared XXXX for we expect quarter returning a XXXX to robust quarter versus net of decline QX growth the before in XXXX sales growth the expect balance

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

operator like it I'd to Operator? turn over to with for So, the that, any questions.

Operator

from question with Yee Jefferies. Our instructions] comes [Operator Michael you. Thank first

open. is line Your

Michael Yee

your come underlying I and last see Hey, data update. And guys. things. topline about to risk about we've the about Couple is, on have for need you've the for morning. and call. come talked One think benefit, in the marketing, the Thanks. various of now, confidence talking Thanks comments the out but call details. your you data mentioned Good positive KOLs overall out REGENERATE seen them last to the

know So, Have yes, about you Hy's law And there out are done there safety. Maybe, us gives uncertainty Mark, NASH, confidence? is, that that? things those that’d publications that? like do stuff eDISH you you we about underlying does we What And there do things, liver you seems that injury what hepatic any some about about to two about cases? do FDA recent what to we Maybe things. it. be fatty injury can the data how What we like know some appreciate talk think to I tell that liver. talks One think interpret could and market liver know and I how few on about safety? be that helpful. secondly, to

Dr. Mark Pruzanski

a paper forward. assessing associated specifically Yes. the potential mentioned, believe Sure, specifically, as It a with it that and latest Mike. co-authored of by data represent hand risk we for was on injury supports mentioned Thanks. With respect investigational group any that happy on experts really overall you does really I OCA, liver FDA of NASH thinking to came milligrams of safety in we're of representatives and going mean, month. liver-related out drug disease advanced the NASH to drug on question factors setting. and last injury disease the these we experienced NASH intercurrent to or in XX injury, do the investigate assess like the in or look, itself your totality to of other you NASH patients how the the benefit cases be assessing with is injury there the on, of context including to active the get illnesses of And, patients itself. often infections there even known in of number confounders before these study NASH the potential what medication causes we've liver are been liver progression underlying complications I in saying meds and and any think highlights are concomitant of that liver liver often potential that

Now, eDISH. that about said, you asked

any level on generating setting. cause just completed. in tool prepared a a really of mentioned data. drug run we've remains continued population in a I lot for potential trial clinical we've them eDISH that of at As to out very be assessing And the of a outputs my to is of injury analyses one it liver a remarks, effective

of duration Just ALT or you for as peak a look for reminder, what bilirubin simply over of injury. every the enzymes, and it values liver plot clustering total does potential the trial in patient participating telltale the liver And lab is study. quite signs

in resulting highlight year to XX reassuring. the population, quadrant very the overall. the as in law of milligrams plot and the who that group. just improving in the and EASL. couple For a reflects placebo, just safety eDISH few REGENERATE, just drug or last similar normal law, One OCA we things Hy's number of And in efficacy is and to respect there's It to XX, looks normal that the near observed. were eDISH arms remain patients Hy's And particularly one plot, disproportionate we FLINT, there looks of both that in liver OCA with that, FLINT the quadrant, in exceedingly presented on a overall very enter OCA XX-milligram we OCA the patients the to believe two three enzymes specifically at

this the the reassuring plot. of So, eDISH underscores nature

SAE. to as or it's Of related important SAE just patients It's law liver one were course, the having recorded that none of an note Hy’s a tool.

we’ve underscores safety data again the here. the that reassuring of nature gotten So,

Michael Yee

So, let me clarify that, Mark.

a OCA. that not saying on were actually number disproportionate You're and on placebo there

and you're So, that that's is saying? important what

Dr. Mark Pruzanski

cases factors Yes. in disease interest. of I whether confounding trial of all of interest of And or these injury assessing a related system specific the of adjudication NASH said, mentioned. highlights again, organ to And SAE, of that a do work because complexity liver require the we active liver And that investigation. it liver on other any continue kind it's or

Operator

Thank you.

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

open. is line Your

Brian Abrahams

taking critical Thanks commercial A a questions. one my Hi. and for one.

course the this be of Can increasing your side, On any And how the guidance general tolerability REGENERATE then, side, international you the us of talked Should give you more on contribution? us pruritus. sense we Maybe should we for give maybe Ocaliva year. on there? Can growth the on the about U.S. versus approximately on coming thinking safety commercial side. be continued details about on time any out you the -- more commercial thinking just on of transient like? experience, both based the your in as setting, senses real trial looks curious as event? with Thanks. mild versus of world in patient what to the about might a just respect the of Clarify pruritus, clinical relative PBC And to the managing this in a regenerate then, your issue? what breakdown this look type persistence setting like and study the tolerability moderate to

Dr. Mark Pruzanski

Hey, question. Sandip the to Brian, the second. ask I’ll take first I’ll take

Sandip Kapadia

Yes, thanks the question. for

in is usually think, I of softness terms year, in from and generally in indicated the softness, insurance at first just broad-based of see which seasonality, a least industry a kind a quarter. we generally plans and reset trend of look, see first the that phasing higher quarter I we the

a So, the quarter. little softer the bit to U.S. be tends first in

as IMS course, you Of know, we data have there. our out

we as So, the slight return on quarter. to But think. see to a that we based our very impact of that you on course, follow I we’ve guidance certainly provided. along on certainly But, launch, first the expect then, can growth

in way the it, point, this markets about think, Europe. at key think I also in the ex-U.S., we're to all launched

the a And so, well. that growth see and steady slow in Europe seeing continuation we're we basically as of

want the take to for good balance as commercial? in that the but the the softness our then of first some reflects again, think and growth Jerry, believe guidance you I So, well. I And then, year maybe quarter

Dr. Mark Pruzanski

Yes.

remember effect, is comments. look, looking associated What’s appears of dependent everyone side of said, this target respect much our mean, expected couple class side your dose into that And pruritus, were an FXR effect patients, field the study on Brian, that this on highly coordinators I and is obviously pruritus. second with to effect. involved, that to to investigators, to drug. be it's that So, effect in question, for clear a study important a very One this is FXR pruritus, going sensitized of were

the it, over look five reporting You FLINT three-fold times, only to three have need a one effect rate of of than at in the was cases manage The how from placebo also pruritus. this. moderate. lot the are which And in very-extensive observed learn incidents to to patients will placebo mild of study greater to we second, or side, rate majority close was on the starting PVC see again, study the at experience in REGENERATE vast

to experience there with PBC up, to world true is do also of terms being the it we it. tends as then asked ameliorate to course. yet. about manage pattern in deal initiation as able of You digging of then, is the we we’re comes what time. same to if in the that. it And and we've Obviously good and tried the in which near have observe ways most that it did over side, experience patients therapy, to real to will that course on it an of susceptible news the time But, patients it kind into side observed PBC We tends be their adaptive don't it, effect;

NASH we context course, study to in that have the Of at look of population. the in REGENERATE the take a

Jerry Durso

has pull-through in PBC, real obviously a allowed finally, manage to to experience us as guess, when the I Yes. we about think the how the I learn you in lot mentioned, to our NASH think world. launch,

ability based educate the the of I I to helps how in the actually in we're in the management of effect particularly both the mentioned early the understand unexpected clearly with which patients, to some where mechanism. can of hopefully, combination the how physicians think guidelines and consistent is support, period part therapy, with providing that key patient pruritus, our deal our patients the physicians information, local on in think and label is Mark

bringing PBC through. learnings we're the launch, So, from approaching I think we're as

the provide as think to the effectively. in to we to try place of ability really able look have which about support exactly good be to to what on we'll kind is to feel also pretty on. going target And the that we do, be plan I right patients therapy at we'll need to that our stay data, we're achieve able the keep

Brian Abrahams

Thanks again.

Operator

you. Thank

Our Cantor with Alethia Young next from question Fitzgerald. comes

open. is line Your

Alethia Young

I stuff. you're helpful wanted dataset my Hy’s guys, two clarifying. just thanks of in safety kind ask into case and here. question, EASL, eDISH of one analysis kind taking analyses question And But, at kind the that like Hey just, hepatic piece heading of is questions, color the trying figure of the for law second a sales on you core the out is to thinking when as gives characterize building then, just I and is you was risk to low? about would force confidence, signal a significant doing the

lot PBC. have of You a relationships from

about, adding marketing in it awareness is is both the is significant NASH think of it than mix like of we should that things? a sales and it investment So, is or more kind

Dr. Mark Pruzanski

Yes.

very I first with look evaluating tool the for eDISH your is and to liver potential of injury. way is standard important respect question, think

result SAE That said, obviously be a ago start, mentioned few very we're eDISH SAE, reported the of that in analysis it's that to So, minutes every adjudicated. I is the related independently reassured liver by needs the REGENERATE. something

we'll data out in fulsome again But, have reiterate that reassuring looks. want reporting on have here how a stress I over we So, the and more to we’ll that to look hand forward picture time. do

Jerry Durso

Yes, second thanks for that. of half the Alethia, the take question. I'll

on to and evident preparation the I payer happen clear think, and when medical the investment, launch in education it market that the we side, there is for the on the side. that needs think is about

at a like key is be audience PBC, calling core the should effective the although sales be effort. the So, in the the PBC is than as It target you will larger launch, going an it force, that really sales launch. we're core of the that. of When in a about ingredient group for ensuring think of obviously team to about on is part thinking every physicians being

we it as expand. good broader So, there reach a is is a overlap, but

stay community with broader it primarily the specialists. a of group is hepatologists to specialists based expect but GI We and GI a

build incremental at prepared an up is there be move and prepared a successful So, towards launch. that be ramp will for to right to that time the

Operator

you. Thank

Our from Cowen. comes Baral next with question Ritu

is line Your open.

Ritu Baral

the thanks Good for morning, guys questions. taking

around biopsy. side, to The the something first that said question market you revolves pertaining research on

as feasible it biopsy launch? Is launch made is of guys your follow-up. then, diagnosis. of make hepatologists, the -- prelaunch real it without something think, to I in to have plan And campaign I patients before and guys an you to get mentioned that sort and a biopsy effort specialists their efforts? address to a Are to a expedite that that part a you most you GI formal

Jerry Durso

Yes. Maybe I'll question. take Thanks that the for one.

who have the that diagnosed, is There out the think the means different into through that relative more are different variety and biopsy. as particularly alignment is the market to have have we panels advanced a exactly market, different disease way frankly, that patients without utilized U.S. that is research we I blood biopsy. a across a system used, physician look looking side As combinations ones are the utilize currently consistent of the not There being obviously. their found they're good alignment, found at imaging not

I system. think the in creation everybody's the aware of biopsy that broad-based challenges

will existing it And be move anticipate of to insight non-invasive in right that think we’ll we're don't therapy that of in the going have detail So, the possible and to will out the of measures forward. look of lot towards we lot there. we I and out clearly are move it as diagnose a goal more information system as be to need a frankly, market that pushing with make to REGENERATE, diagnostic the patients is the -- terms make methods But, at that some biopsy. that coming as clearly of help our easy part

Ritu Baral

sorry. In go your discussion -- ahead,

Dr. Mark Pruzanski

in the patients No, at and this I diagnosing used important really means just does of typically is. add of have The Because that that that just these not. today actually non-invasive critically Sorry. be, but PDFF setting, -- be fat, how would with research fibrosis about MR highlights activity, would specifically approved of again going fibrosis, quantification blown that and much the right? care, was you I’ve it alone NASH you and disease staging not much are full point at to exception or before benefit talked how and whether you only look tell the about

And we we standpoint, value commercial benefit success a staging of better this the better and the here just with for getting crucial So, and non-invasive that assessing go. means fibrosis of as is prop of anti-fibrotic an think both from drug. are course, clinical the

Ritu Baral

had the you've that a biopsy So, potential based outlined for payer so you needing diagnosis, not do that the -- conversations of strategy that your is your some on -- far?

Jerry Durso

so, the payers right mean I going Yes. of -- and kind them. state the we're obviously discussions through with with disease normal discussions having

hand. one which to side. -- sure also implications a payers feasible have data that challenges that's all the variability long-term in try make interested the avoid in payer discussion of understanding able inherent they're of are payer as lot of of I in they're currently. they are the with there address a make side, from And patients that and looking But, to biopsy. something that that advanced points, the market looking and in to from they're context couple creates and complications think, I at with kind we'll relevant of that patients in-depth the works now think Again, extremely are the the in the the recognize out the priority, trying to the more that the

Ritu Baral

you Sandip. And about it is But, that that to OpEx Got growth. going of be say What back $XXX in pulling follow-up of did pairing edges doesn't on whole around out to imply you programs guidance, that it. or order launch there's in the are when lot laid cost; for my pairing a expenses. guidance? you million of implies meet other Sandip, other

Sandip Kapadia

No.

preparation key will an And, I I clearly last year, this we resource allocation. in for disciplined to think, be the I organizational for priorities? mentioned approach -- it’s a much to we've And on very the and priority. mean, take launch year, look, organizational going focused as terms be we as clearly tend very did we of previously, focused us,

We're continue REVERSE NASH And continuation business. of to launch priority of course, PBC REGENERATE again Of support with for also and course, to major funding. our be the the of PBC. in then, continue year program third at

good we're much overall. and organization reallocate really And, look are always there. on the certainly what ensure at we what's important opportunities to to resources to got momentum drivers very really focused we've that either or So, the key value

Ritu Baral

Just is safe modeling that that up and efficiencies SG&A the is going to come R&D? for it may purposes, assume from year-over-year

Sandip Kapadia

we're I REGENREATE grow. continuing they that in enroll to study think, will continue is REVERSE. to no, continue, think and and fact invest R&D I the mean, continuing given -- to I look,

that expenses current generally So, on increase level. our key year probably you'll is would expected the think, SG&A. R&D see And continue I be at to

Ritu Baral

Got it. Thanks for taking all the questions.

Operator

Thank you.

with Our comes James. from next question Seedhouse Raymond Steven

open. is line Your

Steven Seedhouse

Hi. Good morning. the for Thanks questions.

then have Just safety one and follow-up about outcomes. on I

So, concomitant have hepatic actually in big serious serious believe statins AEs, just X% rate hepatic one AE mentioned confounder, about themselves. meds. first, you on digging I the

imbalance wondering high I'm increased So, LDL statin given have here numerical you an arms like there arm, dose dose use seems if explain been, the it reported. the in high the in which may could data,

arm the was I the last statins OCA profile? current anyone the just -- fact, hepatic types in What consistent with -- it Hy’s and SAEs, were high SAE patients the use questions SAEs to that dose the So, were did include in statin not are guess, the did higher on you law. is and SAEs in mentioned observed, that of statin

Dr. Mark Pruzanski

a answer that mentioned line. frequently now. drug statins question good these we're I say, a top minutes that ago, NASH one patients few I think, it's your question. And I on. are the just to adjudicating We as would is, cases recorded on just with Look, are Yes.

of we who also showed simply you, on liver on than typically liver safety those I took in instances, really is we patients result, controls their like. we’ll was were or rare, patients don't in the there take -- What up patients take think in of cases One last fact transient And effect of rare OCA look statins remind and we SAEs AASLD injury liver and can and I'll kind enzymes it profile and REGENERATE even course FLINT, any who no of in so possible LDL, the at safety that on had who though, read could that remind at adding yet in and couple at tell on I It's that are statin that naïve with year at evidence over what rare in is study atorvastatin starting you EASL in dyslipidemic obviously evidence this NASH of the out any we it's looked spikes know patients then, of these that lower look data profile but of recommend we So, actually the points. started there. but either baseline CONTROL, you of because strongly exceedingly safety least, were in enzymes. benefits low with of the dose that both patients that course statins of saw already ended in of experience And a up already added who guidelines do of a is the statins. study, the the prospectively that true of when on where to statin FLINT. statin issue. no study, issue atorvastatin look vast at a I’ll

the would surprised I yet. I course, know don't of be just forgot any second we effect, question. see and to it's So, but part possible of your

Steven Seedhouse

statins. types You with sounds and were the consistent the was observed SAEs if just there of answered you about It it. It like...

Dr. Mark Pruzanski

it, a that are call they're medications important have lot on, patients patients, again, these taking of I that And of remember liver a often to pharmacy lot known Yes. causes and potential of mean well these injury. comorbidities,

every it's there And less than important understand X% less again cases significantly of to that case. single to the complexity an here number So, exceedingly the incidents of study. and in said, is at arm look each than small here, --

So, we’ve which as cases got few ongoing standard a to very is at, look work practice.

Steven Seedhouse

total actually outcomes, number then, in of And whether that to hand or how and now might if XX-month and OCA slide design you have maybe or enrollment the size effect fact have assumptions portion benefit? a to the of the one can the presumably just Okay. last ability in will Thanks. outcomes REGENERATE, to data you of about I'm that events, amend curious histology long-term your that's translate one. of the And on outcomes update

REGENERATE data, mentioned coincide Thank planned will the presentation? of that the You publication you. with EASL

Dr. Mark Pruzanski

Yes.

journal very rate to to at But, number So, well. We’ve will suggests the smaller happy doubt, moving with we've data, as world but the been in from a can't continue our many a for has small XXXX anything a say around directional hardly cirrhosis to be took progression I'm about say what will these nothing patients we investigators need the simultaneous and this in about. we as very EASL, think a results. patients, we from randomized outcomes. that the we’ll enroll good study our as there. in will study, as I publish expeditiously results be too anecdotal standpoint, it assumptions. And, to remarks, to heard we soon outcomes less alluded but the whether the we major as well FDA we include enroll Obviously, to out to at participating it along question numbers respect taking encouraging to tweak possible. but look in of prepared look No that get with than as represent the of over to to continues the feedback Publication, soon study as with we're portion. the be can enthusiastic progression

Operator

you. Thank

with Sachs. Our next Salveen Richter comes Goldman from question

open. line Your is

Ross Weinreb

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

and in the just dynamics Thanks. can end metabolic on front you you where a price given ongoing the may payer space, up NASH? comment for think and how the you to OCA for regards with in Just FXR, And secondly, then, as where and this And on second as atresia stand the would just and well impact your your can biliary programs? PSC on PBC? you our pipeline comment you OCA generation

Jerry Durso

take this answer I'll the pipeline. Hi, Yes. can then one first and is the Jerry. on Maybe question the Mark

moving of drug's particularly focus advancing payers; data, of to you which time a further going look looking when refine considerable as foundation strong our surrogate at we're is fibrosis, area are value patients outcome the I in impact we And with with obviously, I before be the to It in need, continue And the the coming unmet launch mentioned period with off NASH. argumentation. been now ability will stakeholders. and an key address endpoint forward some value opportunity mean, fibrosis to do first to and high for the have our I the working is the of the challenges. foremost, hand, top-line a an REGENERATE data us work, pricing gives proposition. that and of engage guess, be an and So, for the confident for on strategy clearly pricing long-term important they We've to

So, as going it's be where be to important to proposition critical fibrosis is on on for we're further comment to patients an little and premature where the the the the on pricing, except go part of strategy advanced going benefit, we're value believe the any say focused going to is NASH right to we strongest our access that launch.

the And So, sure, launch. future update we to our in work. you we'll more we'll continue I'm as closely progress

Dr. Mark Pruzanski

just Yes. With question, start with respect remarks. I’ll to your which in pipeline prepared bezafibrate, I mentioned my

that to a you, this pan-PPAR is we in-licensed. agonist Just remind

PBC that other compound, this people other Ocaliva. looks And the not in any if Phase that's said data been good two with bring believe in we'll very to it. we with the are is at liver be X published JPMorgan. We're as indications asset better looking the on at it based class. on this setting. than Certainly, to happy this a priority next we that Our combination all have soon, a in, initiate And because

plays. what's to that to at we'll profile is highly It's pipeline a XXX a continuing update respect long And combo potential that's And looking later specifically that follow-on a exciting of work to on and better an but on a XXX. So our building And lot it With moving fee XXX life. differentiated that the OCA. FXR we'll to it in patent then, X indications positioning looking we're We're to licensing still we to Phase OCA. compound providing disclosed be compared upfront efficacy the we'll finally, pre-clinically that. really be looking from is along great further. analogs better compound, preclinical looking agonist -- as clinic. And we're potential news. on selective our today year is ready. about the in for other Based anti-fibrotic a success NASH, with as potential with a very for that which the is And XXX, bile acid do OCA be

Going on that lot a front. optionality forward, got we think of we've

of for So, stay the over more course the year. news tuned

Operator

Thank you.

next Our question comes Skorney Brian Baird. from with

Your open. line is

Trevor Brown

Brian. in protocol and there the definition of if Thanks. wondering This could those Hi. any serious for endpoint analysis definition on Trevor final definitions? overlap liver-related for the was and I is REGENERATE events, the review you is adverse between

Dr. Mark Pruzanski

and north So, meld liver score includes progression of like the mortality. and bleeding in outcomes decompensation cirrhosis, REGENERATE XX, transplant endpoint events composite primary to varices all-cause

I'm -- saying I from that memory. think that

I that composite captures think the endpoint.

we this progressing be most that that is record proven. the a course, we’ll will population that that of be at will biopsy precirrhotic Of given to expect events baseline, cirrhosis which

mark on patients who were four we The scheduled now As study, on patients three-year a and have study. enrolled years. reminder, biopsy continue at and another passed first that

respect don't terms, with investigator to preferred they respect can do And an really, vary that use. chooses events with And the about So, in can to we're outcomes to second your except that really nature. they endpoint, they lot to overlap have right? with they SAEs, much remember, to the can, these term preferred question, talking define investigator variety. reported a So, are -- there's a of

Operator

next with Our Navin UBS. comes from question Jacob

open. is line Your

Unidentified Analyst

to FX about talk for have show difficult REVERSE, improvement looking [ph] the in Martin on FX if guys, signal about population? Navin. Gilead is patient a follow-up. fibrosis the and I more Then this in forward can we Hi, Thinking to is saw study Thanks. you

Dr. Mark Pruzanski

Yes.

the been to REVERSE to been look, NASH, includes to sure cured REGENERATE hep cirrhosis, patients context cirrhosis in who we on have to Based -- patients compensated geriatric not in of it patient The just cirrhosis, up drug we're have really -- a to with it's results with has possible fibrosis, careful very selection, chance stage who've in FX reversing fibrosis of in bridging FX from surgery. that who to in patients of making who’ve but the benefit reported confident enroll reason to of setting it C do going earlier and liver been cirrhotics, drug disease So, cirrhosis. and -- hep more that REVERSE, be respect patients been and the In where including to liver would in shown reversing our ability that anti-fibrotic shown compensated C we with stand their FX. so difficult the NASH in the and C. the of we've of with the patients hep sort unequivocally

Operator

you. Thank

next Our Oppenheimer. with comes Jay Olson question from

line Your open. is

Jay Olson

Thanks taking for questions. the

prepared the payers in most remarks advanced are in mentioned that You interested fibrosis.

commercialization for patients, you would of FX it I And the do So, a be OCA the that expect reimbursement have label study the patients? FX question? for then, or then, follow-up and results how NASH? to FX And is important into get and REVERSE

Dr. Mark Pruzanski

Yes.

so, about think think progressive payers -- I advanced as fibrosis the situation. a

as it’s make throughout probably where But, doing exactly FX. they're that a the a learn out to early clarify we're comes hand. little to going lot payers with progress too fibrosis they the line our the are avoid range. risk. to data further interested And clearly more and understand And in and to into what to again, that digging think, are as FX goal is data assessment set is the I patients data accumulating can start Obviously, clearly, and REGENERATE between understand sure their they the long-term They complications. full in the we effect. making

Jay Olson

combination efficacy then, or nature towards planning tolerability or these the NASH? more it value with is do Phase maybe of and is greatest then, a comment a on mentioned comment that PBC. for can you Ocaliva and that some complementary And oriented and by you reducing doing also, pruritus you work safety it is in I OCAs, Could Is of X the you're driver to for the Okay. guess, a bezafibrate and combination? -- that bezafibrate, advantage And LDLC? is PBC on in what combination

Dr. Mark Pruzanski

for Thanks question. Yes. the

specified focused would evidence intriguing the asked, to general term based And PBC on potential of complementarity the amount the a the reminder, on dose So, in there. good longer think, side, of class a our you By obviously, develop I preclinical improving combination. we'd NASH side. a clearly just way, And, on the And efficacy interest foremost, a for also fixed there's goal profile lot NASH and is of here the combination. rate, I PPAR as of is there that in say be work, on there's the first think in specifically. I our

interested me it combination other there's effective. in would OCA. be for that So, and that top testing, on most But, to also premature certainly we would would be for But, mechanism-based something the is liver guess in certainly, be with rationale exploring diseases. where that of a combo

Operator

Thank you.

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

Your open. line is

Yasmeen Rahimi

two questions. One Good morning, questions, team. you bezafibrate. for Thank taking on my

could you us what Is left So, be? combination? needed to do is longer the commercial study, a potentially can in run talks to so tell a to if the order question. And you not then, completed, have start I long-term XX-week

Dr. Mark Pruzanski

Sure.

indications. we and that complete. and study. we the work we the to been X about platform in U.S. work the rate -- not unlicensed we to done gives may now has commercialize us non-clinical a PBC lot and limiting rights JPMorgan, potentially Phase a and other certainly and the straight advance reported bezafibrate as need it's of additional into to So, right other out to comment that forward There IND. for at I develop talks, But, go compound transferred us the can't

Yasmeen Rahimi

Thank And is NASH physicians? assume and of under then, the my plan primary percentage tackle probably regards the greater you you. care of do gastroenterologist care follow-up care primary I NASH plans, in hepatologists, that probably to are to centers, commercial how patients awareness And versus that? question in what

Dr. Mark Pruzanski

I’m you sorry. but question second? your repeat the I heard of can the first Yes. part

Yasmeen Rahimi

Yes.

in to The is and not offices. hepatology present centers awareness. in as care NASH gastroenterology is the primary regards that in probably part I versus just awareness assume second NASH

you plan that bringing to them? do NASH being educating So, primary also care the and centers awareness addressing

Dr. Mark Pruzanski

Yes.

to I'll try together. so, them okay, -- take both think I

a as focus terms those are to gastroenterology, that in have are of segment advancing treaters the fibrosis we to amongst awareness in with educating It’s under group. studied terms that be lot similar then of in of work emerging patients of specialists to narrow more we hepatology clearly, do diagnosed of but obviously. the a the will of is be of that on launch GI side the will the the majority upon ultimately will that on And education In care groups promotion efforts the be those treated and There's the and REGENERATE, tend hepatologists approval -- well. two heps the of focus primary group our and side. and the patients a currently. currently where group of There the patients NASH that NASH GIs relatively there's are being

Yasmeen Rahimi

you my Thank for questions. taking

Operator

you. Thank

question last is Our Morabito Suisse. from Michael with Credit

is Your line open.

Michael Morabito

for Hi, guys. questions. Thanks the taking

by in targeted seen I that is First, to to there far since get just is And try with trial will the based initial be patients more get that any the the treatment out? know trial through fibrosis for FX want with was like at that there in on the patients want that? itchiness different anything plans there reported? unblinding to there itself, noticing to label that little no those is any least launch or on chance like there patients clarity of you've -- FX any the bit available stage until this, reads I REVERSE data evidence patients the a you so any could of And second, the high-risk just be unblinding

Dr. Mark Pruzanski

had Let in me take get clinical to is that clinical what no trial whatsoever. No, of the obviously second any that. rumor there one patients, But, there we that a around they're evidence on. trying because is going of on no reports trial

certainly, interested last first risk which And precirrhotic including analysis population, be and was most in population. was of the carcinoma So, progression that basis. to the next data hepatocellular we top-line patients of taking and respect developing a disease, the for as reported we on primary stages We full the different more faster cohort at or at include to the or FXs. about fibrosis with FXs. risk out progress or it risk learned question, at a example, more of at important total anticipate very there your thought and ITT exploratory are And learn more week. is endpoint important The look this FXs who going natural FDA we more the to to very analysis we high

what population the With we which across indication look of totality the in will ongoing as definitive And efficacy comments. we've mentioned the of in of and safety the REVERSE, filings. PK/PD also like, the And prepared our is so, be OCA. I respect if included statement to while and have guess enrolling obviously, is the in can't assessing unmet the now will or several data in second the study looking work well, FDA right FXs, would supportive that studies, be completed patients be earlier will label our in different which stage certainly, at and population, know we the meantime,

to on But, will give that approval means we access population. again, to submit FDA initial segment can't have data So, in of in important that I patients. whether the certainly, the these speculate

Michael Morabito

you much. Thank very

Operator

concludes conference. you. This for wonderful Thank you day. today's have Thank a your and participation

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