ICPT - Earnings call transcript Q4 2017 | Intercept Pharmaceuticals, Inc.

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Operator

Thank you for joining the Intercept Pharmaceuticals' 2017 Full-year Financial Results Conference Call. All participants are now in a listen-only mode.

Following opening remarks, Intercept 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 two weeks from today's date. I would now like to introduce Dr. Director Relations. Senor Intercept's Vignola, of Investor Mark Please go ahead.

Mark Vignola

business for on a our today's morning and release and This website. us you thank providing results financial issued Good call. available joining morning, our full-year which update is covering on press we

for forward-looking safety and PSC, potential REGENERATE use Before in certain Ocaliva efforts benefit Ocaliva potential future of which may statements well events on ongoing plan the as be experienced discussion commercial the label commercial as expectations clinical commercial and initiatives, of providers Ocaliva, be as effect use of the who These our call, any of REVERSE and events. today's Ocaliva future begin management results today. the please statements efficacy changes by future and remember efficacy the other are for events of such trials, on the beliefs and our we patients with the potential to and results will including that association and dosing of we of today, making recent the of statements NASH, with statements the the potential regarding other of use, its Intercept's of based and Ocaliva, educational Ocaliva, healthcare relate

this a use in future conclusion product by and otherwise. update uncertainties Our time. in any most including assume for not at authority forward-looking investigational of and those begin actual result Commission, our and Head safety filings as be We from any the revise reports or read closing in other described with results has OCA CEO, section U.S. or No Chief Sandip in obligation annual Form drawn Exchange Pruzanski, whether risks may information, can Factors Kapadia. differ the OCA’s our our Officer, no Securities Lisa other events, our will PBC. followed materially President than new with of from from or should XX-K by report Mark U.S. our and Biliary expectations. efficacy on in or carefully by indications SEC. Investors statements, to Primary Richard recent of of filed Risk regulatory Cholangitis, International, remarks The Kim; those Vice been and call concerning indication Financial of with Commercial, Bright; our our Senior President approved the

will on accessed then IR today's slides We We there the the to webcast are would with open note through section questions. associated the Events of your be can that to that call our take like call website.

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

Mark Pruzanski

million strong vast for $XX.X the continue PBC. Ocaliva uphold Today, reflecting uncertainty time of a fourth the innovator the to have I'm the patients number for countries Company. Good We drove quarter. Internationally, on us to morning described we progressive trajectory non-viral year. we of everyone value commitment the reported or call. great in a their last of to you record U.S., with We in Ocaliva challenging regarding had issues XXXX, coming sales gained our resolute to and leading diseases. the label worldwide in we informing during European period exciting a majority and year accomplished Mark. for and that XXXX PBC in million in access update. despite the achievements even Canada in Thanks, momentum of it joining and payers the maintained a that launch In a patients up and several $XXX.X fact shaping thank physicians a we today's the deal proud as liver

trial. our cholestatic We with also liver disease PSC for the made in programs in OCA another development solid AESOP progress proof-of-concept establishing

of And successful Phase III a reporting the cohort XXXX for ongoing lead NASH. enrollment remain of largest laser we pivotal in the course, REGENERATE Intercept be year trial trial the in priorities. NASH. the on us following interim focused also with keeping as we While in completed outcome in the analysis in will CONTROL a

and reinforcing First, PSC. second growing forward our our leadership franchise, position PBC a in defining third NASH path in

Now some PBC our program. more on detail

used their As Class the X% in disease patients and The PBC weeks you post-marketing cirrhosis. was dosing by know to of patients or Ocaliva to are reinforced population. in U.S. it the a label who it the conviction a updated underappreciated B we PBC patients decompensated at a safety supported our with that of patients inadequately of key in the represents reinforcing liver couple and PBC announced this first reinvigorate important which Such the many is stage extensive Ocaliva, be provides option ability eligible or and our approximately label analysis for of have it step. in benefit directed. stakeholders updated X% profile just we significantly ago, to Obviously, appropriate update getting both advanced has label physicians Therefore, an for PBC hand, thousands when are critically treatment C of PBC Child-P intend in and the believe growth now with the the to in by continues With reengage opportunity. as care. business, addressed we this patients, standard we

full-year very of of a our remains first population of believe number launch. who all sizeable there We our from For benefit can in Ocaliva. PBC [Technical Difficulty] patients,

in NASH. Moving our work now to

hyper-focused program global now and base days comprising we treat We a which trial NASH REVERSE trial, ongoing our of the our REGENERATE couple announced are on ago.

several past and II therapeutic delays NASH developments disappointment. As Phase space we program the considered with in reporting over other companies year the

our position reminded are competitive is. strong how just of We

and currently breakthrough fibroses. the differentiated trial flagship OCA Starting the patients NASH. FDA REGENERATE, therapy. only robust NASH know, to the drug two advance has NASH continues you the of FX on be approvable with be endpoints therapy FX as shown to first with It is in As with designated potential only investigational uniquely both first that our line efficacy and

post-marketing out track this trial while read the enrollment confirmation remain for on basis. on We analysis results to reminder, interim on continues. of with for outcomes cohort initial the follow-up As supporting half the in XXXX, an clinical interim designed first in of on a is approvals analysis benefit regulatory continued outcomes of a

cirrhosis improvement pleased of a percentage announce daily The study week, stage earlier treatment. XX being III trial. The CRM randomized months arms, titrations worsening evaluating XX our daily once to we one Phase primary randomized of after of diagnoses patients three approximately the XX multi-center least standard in OCA three Second, NASH This or dosing in one scoring biopsy is endpoint milligrams to to of are placebo-controlled safety is XX with that no REVERSE with this patients of at milligrams, are histological with placebo. NASH. is XXX months efficacy a fibroses using and the double-blind patients confirmed the compensated due with by OCA system a milligrams of treatment of once and OCA

studies We fibrosis on in reverse OCA intend and in very cirrhosis in that compensated will outcome have trial of FLINT reversal with XX% of significant risk worldwide. power course. in REVERSE rapidly associated U.S. of other enrolling conducting earlier the the based have than possible. the OCA’s begun complete enrollment as cirrhosis, the on failure reduction liver is of REVERSE study countries more cost of reversal all with a of trial. and be in patients the fibrosis demonstrated patient of mortality. confidence the is fact We The We advanced disease ability to an confidence stage in the number we in to to focus population well-controlled but with robust the as the REVERSE designed to

the strong the NASH based the generate III of program of franchise. expanded broader serve broader worldwide, of as a safety the With our the basis of probability word in now market trial approvals robust And reverse, and data have leading which of most cholestasis a and expectation launch program we in our our and Phase efficacy NASH NASH of results simply now the will we foundation any success about with development. supportive that be to access on

non-viral disease, the to will This pioneering primary no in a or that stores a forward approved leading we cholangitis with committed of in therapy. in disease in of months engaging the progressive means with define the in address PSC, innovator As patients. remain way liver needs be liver a population coming broader devastating FDA cholestatic to we autoimmune

later with and and As Ryan positions Pharma another General to the path before has it, Executive was Ryan NASH want this Sullivan, we key some announcement who has take will at Anacor, plan our Vice process management Secretary senior provide expect very number of PBC we the appropriate including an of on and today which a I finally General highlight Pfizer. our Biotech pleased year. PSC and of our regulatory Counsel welcome recently and I’m an to Counsel most addition company at senior update time President, to held Secretary. as team. to companies as acquired by joined defining

transformative asset As to our I will Intercept. for will promises looking a very has our year are invaluable be great we GC, to that new what experience by a ahead the be team. be and conclude line to saying to excited

to based look and thousands the with patients. continue update We collective on patients of profiles label the in pipeline at of growth put those our the experience Richard update. can We to and us centre and safety that, efforts the in indications. the will the further behind reaffirmation commercial demonstrate US in down With of our the for to provide it continuing will others of I road benefits over to turn forward multiple

Richard Kim

$XX.X from a significantly that QX full-year Thanks issued revenue. million fourth achieved DSC Mark In on sales net the in FDAs first net million or deferred the we existing in to in our by $XX Ocaliva million drop and we fourth when sales market patient was the impacted of morning the we Through In sales. Thanksgiving, a one-time significant The net drug of achieved quarter compared on September safety recognition good refills. the quarter, everyone. was saw XXst. communication XXXX, adjusting out U.S., $XXX.X

created with the to that As DSC we believe pertaining the on whether confusion patients them. warning

X% approximately to treatment are stocking C. or be were to of PBC who the dosing X% were modifying or weekly sometimes treatment for to patients, twice-a-week patients saw and reminder, on a altogether. Child-Pugh B We estimated As daily

rates. the the commitment liver making (Ph) In the However, partner in disease the dosing top patients. trend fourth patients’ research our was and asset December the despite this thing of increased the only do. conducted to priority and a year scores chronic market end that showed in Interestingly DSC, Xth November. at substantially of the of on Intercept is believe the incredibly appropriate quarter, in there safety our understood and right as PBC position, [DLC] that the from increase refill prior ensuring Ocaliva focused a reversing We in that Christmas; sizeable to for began

New provide at some which pertained the patients start see after DSC some the patient your DSC, would patients software letter confusion to. at healthcare regarding the with express and feedback, physicians the

conducted, the and/or However the on from safety like majority patients. of next communication research wait regarding for PBT that physicians patients decide we information for updated steps revaluate the they stated to the to would

We our and with label updated physicians have label call providers. healthcare updated the trained has our physicians of spoken mailed updated we address will to XX,XXX former There are to that two in robust. an label that been was thought many position email almost questions our been target have leaders very made Collectively, approved efforts these since have. confident almost our the the weeks to speakers,

with and We have key been educating partners efficacy [indiscernible]. piece our also communicating in the active specialty very updating peers, pharmacy

feedback about updated with advanced adding along event made identify patients with have we to show label with are you updated improve the table enhancements advanced to prior cumulative issue patients repeat are include patients decompensation patients our physicians fall and received warning and prescribers to that here as clinical understand the dosing our is non-prescribers to been on, first first or and C key patients. Ocaliva. clarifies prescribe it positive, as different made see provided both there of that of research for an patients for products We that the The clear highly have the them. services hub how class label is to. that the Interconnect, have term are of XX% through applies a with visibly consistent feedback B cirrhosis that respect box we label type dosing With advanced further and clarity our of Other have our of In upgraded cirrhosis. more the it very all further for current the transition now that Child-P quarter teams most to on these Ocaliva, requirements Our vision that are indicated and the business.

and confident changed. underlying that very feel effectiveness has through the of physicians label we clarity will belief provide Ocaliva we the want see that in our our strong that research First not

our of our notify label the It Although to is majority longer conversation short-term about for update. with physicians have to us will target priority take one-on-one physicians.

reach we to coverage Second, team to our PBC. our to and to are spending sales goal about educate physicians continue of

full and process to us of of XX our time eight to help in team and bring up added have increase We contract the representative sales hiring prescribers. coverage are a sales us potential Ocaliva roles

believe of remains PBC very we the opportunity that fundamental As robust.

are timing or of may this gap, to been patients changed lot higher. net. Medicare of of exposure and but to of as negatively some people have still would living the you their could with like and has impact at to and see turn also our we help deductibles impact PBC in to have over coverage year We benefits, or cost. patients your us, seen coverage now across pocket who your work a I Thank with the year, beginning confidence of dealing Many maybe that Lisa. early resetting Third, refills where the insurance ahead gross our for D commitment ability the the Part industry attention call never impact out is time and a the

Lisa Bright

and Thanks good Richard morning.

Since is be harmonizing with like largely is are the in part most healthcare educational efforts Interim, letter come will caring EMA to at more label for U.S. translations and PBC ongoing in so main actively to the unlikely to little to our have to formally cases I in label underway Autmn, surprise provider appropriating their changes the updates patients involved to In would healthcare and label once these the the reinforcing label outlining the physicians. April as authorities. the by of professionals where through importance Early available available and whether an cirrhosis, been will the U.S. and dosing which the these differential additional patients Access in approved regulatory we in and welcomed. reassurance to the or There dosing EU communicating distributed will believe program. state have miss-spacing advanced First, update on been be member EU provide a an countries of with We background the currently activities is on the Europe. focused be individual of commercially activities Ocaliva reinforce regulatory give

to of net So with year moving and recognition reflects have has been reimbursement progress the December made how by It others year. in Ocaliva on the pleased first million launch the the million sales with QX the call, The the strong on full-year. sales the $X.X XXXX. as our of of uptake UK final and in Germany itself. We're $XX.X Ocaliva for launch from very and concluded and of we an underlying it we we in majority UK initial national and now are expected Italy, in Portugal to-date authorization and encouraged uptake last with marketing and need. pricing the of Clearly, meets and sales see have across to demand rapid earlier France Spain was in following the Germany, following in reimbursement board. good important strong enabled Since Canada pricing Austria and value unmet amongst last

where intending of attention with regional private terms seven to the access public countries current available, in we and XX% months through We Canada prescribe start In and than non-users have summer to to to is broad uses of the more Italy of Spain. this market coverage their prescribing. and Ocaliva the in access completion our six prescribing the all next increase to intent almost level intending of see over a positive six and

in we to prescribers PBC believe develop be initiating of initiative leaders expect our treaters months, to over support and see which instrumental confident developing our we experienced will new across met PBC some top we treatment As for coming countries. the less education thought for with recently clinicians,

major three and and and With to Sandip. to to make and nature and for turn physicians execution to countries they and and unpredictable to sales of to our contribution that, would what Ocaliva to highly place across set all to patients I committed access a be been medical this they the like networks our we the disease. across create XXXX. of meaningful European awareness countries, are all understanding PBC international the have With help do should major continue professional our under now Canada, plan establish years, people fee rapid raise Just teams call to launch we on able of over out have with growth in in of a global of sales focused delivered

Sandip Kapadia

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

to for into detail Before financials. get territory the agreement. would I I provide update on Asian the partnership our an like

rights our our Japan have Dainippon from partner to develop agreement. to Korea required an in Sumitomo OCA amendment and We via existing

As Sumitomo agreed in OCA and China the in part we of amendment, the to have will and and royalty development milestones payments China. commercialization rights retain of for

to in territories. Korean significant rights has We its the Sumitomo value of Japanese and our countries. in to commercialize OCA originally licensed outside these see addition In develop explore OCA any option in the opportunities market country and waived develop intend and

for financials. moving to quarter Now to I would fourth update take results. to the full-year XXXX opportunity our like on an and provide

XXXX. provide position and for cash financial guidance Our

QX compared as me XXXX $XX.X lower the towards worldwide XXXX. increase million of XXXX. year. was for start to QX the full-year for and net and of an and during We million fourth to fourth XXXX remain and million constant represents $XXX.X Let Ocaliva results. end of sales and to $XXX XX% Gross-to-net and million the recognize $XX.X $XX.X our the million in quarter quarter of XX% of projected range off relative with fourth full-year for This full-year our quarter

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

were operating GAAP for COGS de $XXX.X expense full-year, guidance. and adjusted operating in with expenses $XXX manufacturing quarter the [indiscernible]. FDA The to was of until were the line remain was the negligible non-GAAP minims Ocaliva. related to issued previously for cost costs prior For previously and million our as expects approval OCA supplies expensed Company XXXX expensed of goods to million of

also We the outstanding million year-end quarter for expense of notes and million and recognized XXXX. $X.X interest our convertible for $XX.X

position, on year year $XXX.X million moving XXXX. So to And balance represents securities announcing of our cash on our the This approximately ended the our we compared to as XXXX. reduction we $XXX.X guidance cash during for million equivalents, finally, with cash of sheet. of investible a are

said, Given the are label update remind this next insurance quarter. time, Ocaliva proximity I hope That to at as a providing we in industry expected first wide not position would reset. sales the guidance plans quarter U.S. update, the like to in to in performance but softness our be you at to you the

modest growth quarter just XXXX. of the in expect Given we first the fact, sequential

that resources growth focus of on continue repriortizing streamlining and efforts the year operating OCA were advancement expect programs our NASH. and our and development that ongoing be expense of the program our embarking the clinical our we XX Ocaliva growth commercialization our by of for operations to communicated Flat to to We to % in quarter reduce XX% range. in the to on

$XXX the year expect of operating range to million. expense the be million $XXX non-GAAP in XXXX, For to we adjusted

the the of notes. which approximately we component for includes $XX For expect obtaining comparable full-year, interest million, expense amortization

We for refer in the to release excluded adjusted reminder, GAAP non-GAAP as under to compared non-cash Please our operating reconciliation Finally, expense. expense historical represent stock-based that adjusted as to from expense significant expense expense measure. today adjusted will a a press earlier of financial a most operating our non-GAAP anticipate operating expense operating GAAP. is compensation operating item

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

Operator

Instructions]. [Operator

of first with Alethia Credit Young Suisse. from line Our comes question the

open. now is line Your

Alethia Young

questions. for my guys. Thanks taking Hey

of that into a is label and of that Are how monitor kind all we what’s the in Just generally well. have of little looking it like label one, kind moment bit Thanks? can you the have updated their as there or doctors just kind of at little with patients and the about. of you a then just monitor sub-group bit involved think patients talk what frequency kind patients to a often you percentage is more of talk maybe and about update update kind with of the of look that involved physicians

Richard Kim

Sure. Hey, Alethia, it’s Richard Kim.

X% couple elements the its chance a for perspective aspirin of is, followed what’s PBC think when concerned, way we from or to heard who from UDCA months with of patient you on Child-Pugh usually patients, is of Ocaliva six NASH Right from about well. we think sort a as but monitoring bit, X% patients see and patients Vierling compares a Baylor hear of I’m as pertains it monitored, up we of as to is as monitoring now, we consistent is category. John I University. your access there of that RSV physician, far and more had or B question describe X% how are maybe the Class are patients actually our that far Dr. percent the not to. I It patient ago, weeks As about are generally to little about these ongoing basically as standard think right three And competitive label, C. to I whether they’re an advanced in as guess on every in now our very a approximately care

today. X% to So at over started has now when that X% launched the close we coming currently been time, be said about I and pushed down it X% number to is it has

Alethia Young

thanks. Okay,

Operator

Michael from Jefferies. comes question the Yee next with Our

now line is open. Your

Michael Yee

clinical it's that new what talk on for sales talk the then in you study. to your morning can perhaps have on little to a that contract study; just think perhaps that one I have given does about what side expect I a gives force announced, you I anything. guess over in and know some guess confidence questions, that you study, Two impact wanted commercial. that confident good which Thanks. might are And Maybe grow Richard; you I how this the I confirm FLINT guys. based patients on what happening QX. QX Hey, QX pre-volatile qualified add bit a to even you powering, the was you even reverse and the just QX. about on. little for bit quarter,

So with in about study designed the your the thoughts particularly maybe talk how the that you year and endpoint. one around conviction

Richard Kim

Michael. Hey Yes, thanks.

advanced here can business answer be to Basically, XXXX So question past, as XXXX. going to far marketplaces as quarter approximately would where is our used be with top in increase get of we What I really over a intention QX that's a little we Q a to the but in has concerned, make as And we reach future patients hub growth, identify Ocaliva up to so I physicians about another to potential will well. we and see will now, these with physicians updates prescribe In we to that’s I the that treatments managers This and new we the CSOs, our our across CSOs. would we foundation just them to turn clarity of the was quarter consider on physicians are our for a the very earlier is territory said QX about that making target be we to us. a in in how really of overall baked XXX think what Mark. TBMs, physicians. your know XX I priority harbored really the communicate transition all the sure addition cover next to is to saw over we a once our XX, be a question as XXXX in up of our priority which the modest label, physicians having

Mark Pruzanski

Mike. Yes,

with patients that's early to reverse to as our the my on results FXs have on the the scores be out probable took look NASH fact we again, and So will with able with early basis mentioned advanced base confidence a endpoints these a which resolution in fibrosis FLINT was in in in I influence on for both that compensated What reversal for cirrhotics. patients to fibrosis the we prepared significant to the assumptions are confident reverse to powering robust continue there. in number we're respect at based the of And we specifically did cirrhosis. that disease compensated we on remarks,

Michael Yee

if remind go percent and what's that population. what how effect of many the as patients same me And rest back I hadn’t FXs the to the was basically slides the in the

Mark Pruzanski

about FLINT in we mgs, OCA FX patients enrolled and in cohort a front I numbers to third now. improvement robust of most of have So, the the actually XX the in patients. randomized right fibrosis had And fibrosis. don't right had me But that in the of

Michael Yee

Thanks. Okay.

Operator

from Somaiya BMO with Ian the Capital. comes line Our next of question

open. is line now Your

Ian Somaiya

taking for my thanks and you questions. Thank

you're therapy share that of update? coming FDA physician Richard, just issue with on you to and the an communications label the could getting what to that what's of the are you impact community. are negotiated I know a during and if new the to question persistency the compliance post mentioned type us are First Curious on start type from feedback are see of your patients that label. had you

Richard Kim

no sure Ian problem.

So first identifying I lot think a remarks, as how feedback more far is I Like cirrhotic advanced monitor my providing prepared the patient. as in labels and clarity find and better who said to people the concerned. generally, really

impact the good. is really So

this fact the Safety had Communication uncertainty lot a really think previously. that that of really the I Drug appreciate removes people

again, to the As far a as much out bigger actually participation FDA. the Once persistency saw we finance. post rate from of brought

in like concerned. earlier, saw trend so stated we rebound and as I in feel quite far December we as that As normal of bit are sort the a we back that’s

motive saw start as As little where to. patient of are weeks But labels far year, because of peaks since able far But some and who about a impact all getting normal question at biggest as are their last couple sort think Ocaliva. new concerned, the really patient as related I the had to of physicians group a updated. bit of to prescribers of end think being only DFC we was into the across been we people of sort the

we So the labels with PBC a normal about I to being get slightly say their think think time how physicians will more there, patient. in to see what state out with I back would

Ian Somaiya

just in whether on or development Okay. And NASH. PBC it’s

to a you studies enter to be speak sharing We movement space. or level in seeing just investigator are therapies. the collaborations sponsor participate developers into on of other willingness know commercial focus toward launch. that conducing trial this with combination certain I and it the you your on are in clearly But data whether

combination that Just a anything future? which the might in opportunity in speak regard, to

Mark Pruzanski

Ian. Yes

the that So are that quite marketplace. kind same to that time, clear been we suggest willing, there it’s saying and and efficacy you at side. that for least in that space NASH everything have on have and bar is of the been approval are the on our yes, gain the on on the to is demonstrate it have exceedingly side, both high right out time and eye NASH required the got to At we histology we PBC some is

are believe, are coming recalibrated early of year’s the been frankly, mentioned frankly on space. flow, news this had to most mechanisms the in yes, there NASH to positioning Safety be And therapy the keep backbone data can that the and will for overtime, view I simply Efficacy and segments of mechanism. we least disappointment have the And there I I’m of yes, disease. we have that that first-line look at committed this things and in a from population exploring added therapy with remarks, still space, past sure other robust right be that we back if to fact finally that our drugs where my the at number action certain as in OCA you supporting profitability As it’s days on and

Ian Somaiya

Thank you.

Operator

Our from Deutsche line of the comes Navin with next Jacob question Bank.

is now Your line open.

Navin Jacob

there question question quick on burn That’s build one. a in inventory Ocaliva? for Was QX Just any Sandip. or

Sandip Kapadia

No.

noteworthy bit period. talking of general mean the And you been Our inventory you about our trade inventory, increase to typically for it will are has stable is rather well. I think throughout impacted up holidays inventory. I the see increase a mention that assume I of typically, typically, for a little people the list because there little nothing the that as bit but patients, as of go an sales, holidays but

Navin Jacob

a for then P And Mark couple please.

PKPD doses you done milligram the kind in on at XX are that what confidence you wondering milligram modeling gives the XX patients right study, have Just and NASH. of cirrhotic REVERSE in

Mark Pruzanski

Yes, thanks Navin the for question.

currently you in the know don’t indication. the patients test the is compensated on on to the to of important the anticipate same NASH up as are in population case that dose felt cirrhotics. range was modification liberal REGENERATE equivalent PBC other it that So we or testing just and frankly sort in We including side dose related we any side

be our frankly PKPD choice dosing important for that do It have these active. know the we that take know that the dose informed at in and XX FLINT. it’s that to think is worked the We XX also I us have that to work of look in - tested completed patients but that could we you a dose believe only reason was was FLINT,

REGENERATE analysis, So was to we in cirrhotic. important know we we for felt doses the the will compensated over it test the interim turn card on when same SAP-XX

Navin Jacob

wouldn’t Yes, there out potential is those down you architecture X milligram I’m different, to down you because fibrosis delivery further that for is concerns there I further anyone the drug accumulation asking to of so is regards going fibrosis scale like for a why obviously for and any example? scale just concerns think know the with guess that subscriber reason you the greater you go. up about go the about the Why of out

Mark Pruzanski

think modified marginal is those. the exposure frankly is the drug the REVERSE the Pool saw the once in population it’s release cirrhosis, remember none important this compensated seriously lever. majority less of you the there unmet liver our And is only circulates very it of to levels you Acid have exposure with and remember about for think Bile in increase to and cirrhosis. hepatic a But important cirrhosis, need we the just important premature how the studying cirrhotic compensated with in dose early failure in is in is Again patients disease press to And said, patients and highlighting what’s some drug and stats the frankly Bile that the with very that highlighted progressing represented progressive trial death. risk it’s I most to

felt dose modification So compensated the cirrhosis, the need just as that’s with don’t is NASH is compensated which case, there patients anticipate for dose with we in upon based business no PBC we modification in cirrhosis.

Navin Jacob

this the And had of you prior in see trajectory we to to safety scripts inflection return warning. type to start happening then final question, see can when to an a

Mark Pruzanski

Richard?

Richard Kim

Yes, question. it’s great a

transitioning know think I get be quarter will us message one mentioned previously, out the as as I you think quarter for a we there. I

earlier we I and as mentioned where label updated maybe get what I having and the prescribe greater to think credit business active effect the caliber. can get once communicated

confident that. after to it ability about feel to back our for take that get I will growth. some we time do I But to think think should us

understand the we made want have that as one-on-one people have the a the update people notified but to well. those We the to about priority have conversations truly over label, that impact of

Navin Jacob

timeframe, the So, of second second half does like half type XXXX? that mean

Mark Pruzanski

I don't I actually get Yes, guidance, with and on label. informed mean we but specific once one-on-one we passed updated our say would provide really having conversations

we confident back more think our growth. to about feel get said to ability I

Navin Jacob

taking questions. you Thank my for

Operator

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

line now Your is open.

Salveen Richter

for taking Thanks questions. my

just Ocaliva. if as to strategy Thank think physician what about clarity affected, second drops then around And Can you rationale your you. was were us refills. your patients of you were, they give Just in regards [indiscernible the that. outside just the expanding patient question (X:XX)] comments around your that and of pipeline some in BD on

Richard Kim

the are first question part the far the as as concerned. take of refills I'll Yes.

be pertained So certain would what the saw we is with to. communications drug I who would people is say in marketplace safety what

so general starting the we was than we're of actually clear in twice-a-week that we weekly, one were saw for So saw dosing, something were either that, and have issues what [indiscernible] daily on sometimes time. less going to who people

December As part holiday rates in the increased rate. we quite of saw I as significantly repo mention, did

we have market around patients what research of I one evaluate So also as the heard communication. period the the of their is physicians They well. into majority currently been plans planned clarity have to that

take want of I you the the think part second question? do Mark,

Mark Pruzanski

Yes.

we on frankly, side. I saying, remain that's I you PBC a parameters And the clinically mean, But as to we're it So a NASH BD demonstrate biopsy everything driven. that and out the have been the at And been front, few histologic think certainly there OCA, histologic, ago are the has improvement actually I this high. in data based just addedly bar the it's dose says meaningful on approvable commercially. meaningful I fundamentally looking very on think we with the side, minutes that need and is very, NASH mentioned and case

none that that bar in outside is is really Frankly compounds of OCA met well-controlled of aware few high, a managing have a there So on study. robust were it.

looking activities forward. see And to the so we growing you will focused going business building expect and pipeline should us engage keep as we in on

Salveen Richter

Helpful. Thank you.

Operator

Cowen. Our next Ritu line the question of comes from Baral with

Your now line is open.

Ritu Baral

Good taking the morning. Thanks guys. for question

question on REVERSE. is First

you the why can primary to as Now REVERSE? of take endpoint

Richard Kim

Hello Ritu? Ritu. from… So lost We differs it

Mark Pruzanski

we seems lost have it Operator, Ritu.

question? re-queues, she can if the see we will into We go next

Operator

with question from comes Wells next Birchenough of Our line Fargo. the Jim

is line open. now Your

Jim Birchenough

Yes. the guys. Thanks question. Hi for taking

over mentioned I’ve remind fact clarify to for then power a the could REVERSE. REGENERATE group. what study. but XX% wanted Mark, us you level what on assumption powering if just is the got the Powering And power, baseline control changed the follow-up. that XX% the And for what a you is I So for at

Mark Pruzanski

Yes.

the we there. Jim assumptions are endpoints on But speak we made, sample going over to that behind selection – also it. patient to I’m to powered on REVERSE. in REGENERATE, our XX% led specific get the assumptions, we in both size into we So confident not assumptions for and our are

Jim Birchenough

or treatment between distribution about commercially to the overtime, to two thoughts how of us, upper out for have and or that just treating straight three started bit just times physicians normal who times need maybe physicians in could limit you that decision to a maybe you the then limit and initiate out increases and there upper that’s talk Ocaliva And earlier? there’s might with there Richard. Could how distribution progressive our maybe, you and that’s normal changing speak a

Richard Kim

Jim, it’s great question.

as people we to - labels and define continued our have that before, kind explained patients of obviously, differently. physicians different So to

are it as patients I as advanced lot are said we with disease higher a or new more uptake have seeing coming we need, lower that is levels to and progressed, it’s earlier, of huge in I saw with As advanced mix. more there unmet launches product think patients whether we less with disease

example. that [indiscernible] sources So, lot other and there has been data the talk a about the impact recent out for of levels interesting of

respond see needed sort we as well. emergence to definition So, of order progression the as evolving natural around a marketplace in in

Jim Birchenough

question if And me. allow final you then one maybe just could

and data do terms For history. to just a PSC, how is PSC? on type around outcomes looking regulatory group well-developed is, of interested the do discussions and predicting I’m envision strategy how in study history much you phos having like natural of and in alk focused Thanks. the super in there What surrogates and PSC that’s natural at

Mark Pruzanski

question. it’s an Jim, important Yes.

at remarks, know very supporting and before said are the work ago we stakeholders at endpoints this, path PSC. we should the and say you take some but clinical exactly endpoints, like. several a phos. the expect endpoint we with look FDA course as looking pretty me keen in multiple longer There define my in forward. it’s for that, mature some which PSC be believe remains and other us And pathway potential sort are a we or what this. mentioned I again, that to FDA I considered and are looking As pathway likely necessary, could support year forward. going with defining it’s the could can you relevant clinically now, half hosted insufficient And undefined. is I its alk literature in in Alk manner are tell workshop in a that to but committed the to adding what right recent relevant, it’s composite a is But are phos, to accelerated relevance disease is of to to to time, approval

Operator

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

now is Your open. line

Brian Skorney

the thoughts study. stopped the to study. details wanted update for with NASH the understanding XX dose about on rights XX me. just opposed thoughts why the taking coming around doses the on just to to the get dose questions. more titration REVERSE for guess, an Sumitomo, straight some as the I the in just Hey, good specifically, Thanks I mg the back Japan just Two mg morning, And get in my you. from to guys.

on looking on NASH what just thoughts your your you’d when in time do something development some Just Japan. are Thanks. own there to or partner? this you they is further planning in are explore really it Is to to cut

Richard Kim

the Yes, hand one to first then thanks Sandeep. take will and I

true that’s titrate in tolerability that specifically Phase overtime And we but it’s dependent a CA, five to in hope overtime on with in be you the significantly if think remember will we side I our PBC with way principle very, program we well XX, here. our XX III to place [indiscernible] sacrifice prove efficacy. to strategy demonstrated from very titrating the decision us served in XX to the see to the with ameliorated same no you respect dose there that know

the there also informed to minutes doses selection in dose do well. mentioned in we And to we some want reason so our FLINT of course ago, well range. the this you PKPD question is another know have test good which XX in that the have few I as data that a XX response worked As as to of

Sandip Kapadia

excited the the one, know will requiring I say Brian question. second then about can And is we take really rights. are I you What for thanks Japan

know great all to different we is Japan we you pharmaceutical looking and how at As best for various and value of there options in a terms there. gain potential see major OCA are

Operator

Beatty comes question Joel of Citi. line with next from the Our

Your line now is open.

Joel Beatty

and good for morning taking question. Hi the thanks

dosing is trial. on REVERSE question the first The and

with and patients as earlier use is dosing a to a in-line question. patients PBC similar dosing Would and patients compensated PBC. is you mentioned cirrhosis I those to plan decompensated in cirrhosis question in have compensation these the for I are for advanced My of with is trial recommended patients follow-up heads As cirrhosis. then

Mark Pruzanski

patient there cirrhosis. such safety is that taking? taken a and is study respect with shop decompensation double-blind but catch that tracks possible unlikely remind advance to and a question appropriate to look product year could phase time one on and just steps in is a, true and place a probably said great compensated who it’s study that patients this advance application It over to do you it’s Yes, the is just in as in that to are course investigational

Joel Beatty

then showed thanks between clarity and you and label last the difference Okay, feel and survey current you Did one that non-prescribers question about the any related physicians OCI. how results to the notice with prescribers Thanks. update. or

Richard Kim

the There think wasn’t little was higher with of already but a bit well. much to see I rates that it what as pleased prescribed there who difference people so one, of lower response were Ocaliva, not but a have prescribed I it with was wasn’t was experience who have much folks

Joel Beatty

Okay, Thank you. great.

Operator

line of Oppenheimer. question comes with Olson Jay the Our next from

open. now is line Your

Jay Olson

option. develop you hepatitis to an the effective study OCA potential consumption example my where that area FXR is guys taking moderately for have Hey I no did had on a for Phase an about I and you or signaling. severe to at looking II thanks this the in of alcohol work study TREAT Is alcoholic question a pursue plan longer the development some notice question. alcoholic OCA hepatitis, for second

Mark Pruzanski

on and you time XX frankly there demonstrated study. is pursue several in. OCA experience years high it's Initiated need, venous we a that first and And intend to of XX Look, the need TREAT an in another population. is short clearly do population called a that's We're doses an where period that that unmet unmet mentioned a days decompensated cirrhotics relatively the and research is at proof-of-concept portal milligram way with which hepatic so tough there Investigator study Actually with acknowledging over there IST the alcoholic a our it's C studies patients to pressure PESTO B XX while and we to Child-P in hypertension. including study ago gradient XX currently for being

Jay Olson

there follow-up there? update wondering countries. color is hear about can just then Europe. was remarks. And I Ocaliva in Thank the if the you. commercialization you of you any Nordic there mentioned didn't progress Italy for one thank And of reimbursement the or on I Okay, prepared in share the

Mark Pruzanski

Lisa.

Lisa Bright

thanks the for Yes question.

progress know we have pretty made pricing we reimbursement good across in Italy. Europe in as So terms of

pricing we Specifically to continue national reimbursement. in have

usually that little know longer. bit you As takes a

a place perspective negotiate real in now from but to is national the across a So opportunity on the good we're region-by-region basis.

are our that involved heavily now. doing So right teams in

And we far, so have got...

Mark Vignola

Yes we Lisa. can have Jay we link. lost we Lisa lost look have follow-up.

Jay Olson

you. thank great Okay,

Operator

line the with comes from Stanley. question next Andrew of Morgan Berens Our

line now Your is open.

Andrew Berens

that PKPD the Day one guess of couple Hi said call. Mark you of is more thanks a then And questions things response Maybe you guys The the review the into Ocaliva, that are the decompensated in I and this model during up how does about Valentine's taking it talking then happy question in financial of question. and cirrhotic. And of for the concentration liver systemically? liver drug concentration also process. patients guys. I'm in the that in put go

Mark Pruzanski

in Yes that's actually enough and liver will do all it's trial, is which and the patients that decompensated And [indiscernible] a predicted recommendation case in modified NASH And decompensated in it's Child-Pugh I clinical to Class go for to but confirmatory in side. in possible side my advanced advanced and modify dosing for more this C outcomes possible drugs to the of And up include that intend many the and as in PBC PBC patients. to study the mentioned an Ocaliva remarks, also the overlapping, we design population to more and similar dosing patients. the there. label cirrhotics follow-up REVERSE patients the basis B

Andrew Berens

Okay.

that the the guys I there systemic it’s discussion, you the read think now effect was the dose concentration process the documents. the I least - do sounds was So that reason review Has change on like in felt FDA where liver. like from there? than mean been At changing reviewed a to the the rather the change like and in

Mark Pruzanski

of go that predicted levels, in me. have to don’t reflect think documents patient frankly plasma levels is in dose-per-dose levels bile reviewed the the label exposure I liver issue any up. I No, not of decompensated do the But in that’s that hepatic the acid in Systemic a going of front fact acids. bile introduced is the

Andrew Berens

I follow-up Okay. offline with you will today. guys

Mark Pruzanski

Happy Yes. to.

Andrew Berens

And Would that it that that NASH? will would you that as then on confirmatory XXXX start just currently understanding be addition REVERSE? in a COBALT of part trial? guidance. question trial trial? when of potentially my include, another the the part And even that is there guidance large Does And confirmatory trial expense expense be the your a is to or

Richard Kim

care. I mean, would take I

that In as and terms well NASH, of are confirmatory related guidance, of the of obviously guidance I on really PBC. be and commercialization beyond as the trial XXXX as the this guidance very mean, the as that REVERSE year. development our we much focused ongoing in programs the the expenses does note include trial not as part would course, for The something included so well of to

Mark Pruzanski

a couple points of additional Andy. And of here, just color

frankly, But the study should study. histology pathway, PBC it’s for point down it to point? confirmatory it’s of have underway data the at you the then going phase approval prior will to that And on trial de-risked part our in Can similar some big the road. also at of going on post We to know reach to basis be be speculate this study in how marketing that have you as sense to And under approval. accelerate be out design population. the and the on be very COBALT, will to to well regulations marketing

Andrew Berens

you on the last decision color and us of Can with give just program Japan go to in then China? the question. And not some SDP’s forward outside Okay. an

Richard Kim

of see what business mean a or requiring I say, can’t would committed OCA really ensuring and of we really point. very excited I that those of there are we We said, lot as But potential on evolving rights. in We some the for the sort Yes. moving we I certainly about And the year. are at goals to speculate Japan. forward

Andrew Berens

Okay. Thank interesting. That you. was

Operator

next question of with the Baral Ritu from Our comes Cowen. line

Your line is now open.

Ritu Baral

guys. Hi

endpoint the monitoring question the versus requirements? team. the risk safety to these on I Are at and for NASH earlier. question REVERSE for and over question sales also already move quickly. will go And another And Sorry can CSO of you the XX* patients primary One contract Why [indiscernible (X:XX)]. the on REGENERATE? sort then about REVERSE in the difference on

Mark Pruzanski

Yes.

burnout, often So I exactly mentioned not the Once you reason you progressed quite hepatitis. that just state you Ritu, as would see the simply all. as cirrhosis

going to population with just of And focus this a is be compensated foremost. The cirrhosis. clear, patients and endpoint first one that with so And no in NASH which so in one at case of the while three is of have in in on to stage thing from fibrosis study REGENERATE. that two worsening this improvement, this to is endpoints least reversal identical NASH is to four

Ritu Baral

requirements I part in the protocol now? was as safety monitoring of right

Mark Pruzanski

nothing it’s a that – get from design frequency study-to-study, have. standard, to into get details Just of we standard we we into work. so don’t studies of ongoing, visit We don’t but have a lot on study

Ritu Baral

materially that be different to fair it Nothing Is REGENERATE. will say?

Mark Pruzanski

Yes.

Ritu Baral

office is can it sales over exactly you who permanent expect Is of sales more of contract the et you your a size the expected any the to cost, the and they’re community? different detail there effort Is then doctors it part And cetera? on force, part go the do Okay. and be targeting.

Sandip Kapadia

Hey. out a and about I Ritu. a of mentioned always physicians that there as we have to reach. there PBC and disease patients Thanks, is still think lot large who rare

numbers somewhere you XX,XXX the cover what say far is, But and the X,XXX costs. off as to and we we concerned, gastroenterologists, final are as there sales to around XX,XXX know as of only them. between So still I is would is X,XXX working if

as during to to physicians, there to centers patients who and So have ability may believe as get well. there more our actually larger the few opposed reach expand we is a

and know other through care within there specialties there claims many data patients also are do prescription that We as primary are lab well. that offices and PBC

intention we for going provide these So are where those physicians and more patients is the our forward? to sure right understand make of

Ritu Baral

this And expect this to do forced permanent; be to at it permanent point? you be

Sandip Kapadia

what and pillar coming me are what really to is think share in we is is has to this over learn told quarters lot we permanent, we our for My life insight that say we’d doing be are as important going would very but a mom well. happy I the nothing I learn and will a

what’s and see this to we lot where going So, a have we and I to data we we on first see think of and validate good want goes. out will there want get that

Ritu Baral

taking Got it. Thanks for the questions.

Sandip Kapadia

Thank you.

Operator

closing And that for to Mark like session. Mr. concludes any call the turn today’s question-and-answer would back I remarks. Pruzanski to

Mark Pruzanski

in listening today. for contributing everyone thanks and and operator Thanks,

for prove non-viral PSC others year XXXX of earlier, up mentioned PBC, a and and to everyone Intercept NASH on super-excited focus to we behalf I As in continue liver patients with company and will pivotal progressive are on be diseases. the to

will our of NASH PSC. to anchors to year and REVERSE PBC program clarify growth in We on return this leadership in REGENERATE and in and Reinforce position deliver III a intend through our a Phase the ongoing path opportunity. forward

we maintain our without wavering and the work commitment will the any company patients we at to see time. the We inspire do you will every much Thanks next day. very

Operator

disconnect. great conference. day. Everyone, in you for may your and program today’s now Ladies This thank a concludes and have the you participation gentlemen,

Intercept Pharmaceuticals (ICPT) 14 Feb 182017 Q4 Earnings call transcript