ALBO - Earnings call transcript Q4 2018

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Operator

Good morning, ladies and gentlemen and thank you for joining us for Albireo’s Conference Call to provide a business update for year end 2018.

Following management’s prepared remarks, we will open the call for questions. I would now like to turn the call over to Paul Arndt from LifeSci Advisors representing the Investor Relations Company. Please go ahead, sir.

Paul Arndt

Thank you, operator and good morning everyone. today’s Albireo’s which performance joining an will for on update in you call management during provide Thank XXXX. full financial Earlier release today, for its highlighting press December the results recent business XXXX. Albireo accomplishments and issued year ended a XX, noting via is company’s website The accessible at press the release www.albireopharma.com.

forward-looking Reform let XXXX. Act me include comments the under today that proceeding, made Private of Before may mention statements Securities Litigation

any obligation approval or results including fact including any submission prevalence for or scope, Albireo’s the by the factors or described statement commercial of the in Factors a plans, location, timing initiation to coverage, its today additional for Albireo Phase cash expenses. or X potential include trial Albireo trial, Forward-Looking heading for for HealthCare with or EA that materially statements cautions statements clinical its or or representing upon reporting not or size, fillings costs any or March recent is those timing forward-looking on development of product and in conduct, Forward-looking of relied cost completion design, the Actual of forward-looking in or resources Albireo’s earlier progress, as for expectations most Partners statement. patients made from the or Albireo’s statement, by target results any any Cooper, of indication, as AXXXX, product statements speaks the in or which to views I PFIC, position, to payment be implied disclaims period Also, for XXXX any including differ elobixibat, over Albireo future historical SEC. forward-looking and Ron data, may other as from population, press statement that, Ron? applicable AXXXX, many future with release plans target Statements regarding call XX-K from as Form today, CEO. under Risk candidate, of indications other or Thursday, will date. Albireo’s of you duration including any AXXXX, any program, to revenues, endpoints, heading regarding of update objective, for later feedback or make AXXXX of outlook duration, only will as sufficient in Albireo pricing results the President development opportunity of be X, regulatory any Royalty Pharma Albireo, requirements, under Albireo’s undue may that except operating turn any law. the expressed required result place to reliance or Albireo’s reimbursement, With those financial for than operations, fund not should or candidate program forward-looking any

Ron Cooper

you and Dr. Horn, Paul joining Simon for Chief Medical conference Albireo’s me Officer. everybody Harford, you, call. Patrick and Chief Thank Financial today’s With our thank today is Officer

in plan which outline on pleased to commitments. XXXX for XXXX/XXXX. year was an our today be review XXXX priorities are we for versus very delivery our We and important to here executed our

other supportive our key to commitment which with We FDA a quality gaining approval commitment proceeding gaining XXXX. our on issued placed in and in on of elobixibat, according to launch AXXXX plan, of high continue bile commercial trial presented commitment as transformative during company our conditional Track approved liver And leadership of our of history XXXX trials our we a of development me begin orphan that And We the acceptance strengthen our period. manufacturing a chronic for guidance Simon spring. let communicate began as our the XX Japan and as XX roadmap expect as line Treasurer, medical constipation and will with on plan and scientific regulatory Jason gaining the expect first FDA with proposed this inhibitor position, pediatric our further our Duncan period a commercialization important scientific our U.S. and were it We IVAD EU AXXXX AXXXX data and European XXXX. making natural ended of our PFIC modulator diseases liver name. a and the Priority at designation top and major review IVAD approval February delivered the in and delivered the our and commitment PEDFICX U.S. on for CFO XX XXXX in the approved the commitment combined We delivered Review We acid the provide XXXX. Albireo validating was the starting We platform. will to for in eligibility delivered U.S. well on achieving Fast of the on drug first hires be as our versus with as But prepare half to the Counsel. of designation XXXX. delivered AXXXX CMO in Elobixibat Voucher on early XX, of year including and to the I for world quick brand meetings. agreeing is inhibitor efforts we the our General on PEDFICX Pat to INN

see strong a XXXX, in progress can excellent which XXXX. in prepare XXXX for year to made you base as success we provided So it’s us and was a

and move the let’s for roadmap Now Albireo. XXXX-XXXX to

AXXXX number ready larger one, the Phase complete two, authorities for Our study, priorities regulatory bringing Number NASH biliary X AXXXX three advancement PEDFICX significantly approval candidates submit future. a to initiating acceleration as modulator number are; our with enrollment in elobixibat development launch; and to of partner of for compounds expanded by preclinical bile trial in acid a three, the of to atresia; and population patient

detail. Let me greater go into

our in highest PEDFICX remains study with PEDFICX priority. of the anticipation or results First we early expected much which end begin XXXX XXXX. PFIC, for year this are

controlled we The to durability in enroll XX is long-term assess evaluating with FDA the blind responder end weeks. X for the type The AXXXX designed label doses open point trial placebo or secondary patients multi-centric EMA response. XX optimistic type control primary two the progressing outcome. end acid is this PEDFICX of the The evaluation pruritus. and end a is improvement endpoint program of the X approximately the for for So bile EMA secondary as safety and FDA key X is a reminder PFIC and about extension randomized to in rate. point well primary key for trial clinical study Phase for and single is remain serum point the and double placebo

preparing AXXXX we the refine in of get half and XXXX of approval and we We launch first for will closer. potential are guidance as

extremely Second, in excited studying atresia. biliary AXXXX we are to begin

to use of biliary Alagille expand PFIC syndrome, been intent Our atresia, has AXXXX sclerosing cholangitis primary into the beyond areas. and always other

our begin major the that biliary need pivotal will do And AXXXX this we half XXXX. atresia, large of disease We are with announce of pleased study pediatric unmet second medical in will a to in rare liver we and relatively population.

indication in resulted the within about liver is ducts results of biliary liver pediatric patients liver weeks making two decades transplant of Damaged atresia first birth. biliary acids and being inside most for the Now weeks bile that require cirrhosis liver atresia developing a life failure. XX% transplant. the trapped absent bile common About and of bile or after disease the bile two and in ducts liver with eight to and symptoms

U.S. Now patients common EU there one show no combined. available and estimated to are most with data the although published is estimate biliary pediatric liver in of our XX,XXX diseases prevalence atresia the patients rare XX,XXX

EU We have received for atresia orphan regulators we and trial engaged AXXXX the designation in biliary drug on and U.S. the design. have in

are the will starting trial details saw the Albireo in of anticipate liver in are in coming study the build XXXX disease. pediatric our the of more we rear we and PFIC We design for The encouraging will and and results second Phase X the regulatory months. finalizing the cholestasis process the atresia beginning we on half the with provide pediatric in trial authorities. Biliary trial in in

additional potential in pediatric expand continue for We XXXX. orphan beyond and diseases to liver plan to indications see development initial these into AXXXX

acid perspective. Elevated for tolerability a a Now, to development steps year And liver on clinical third is acids rationale bile the fibrosis strong orphan Bile the NASH NASH liver efficacy continued important an modulation pipeline in with of cholesterol, This convenience priority. patients. provides and NASH has insulin of pediatric are forward Albireo plan our elevated in key NASH. from while inflammation this along both development and diseases, to our markers attention. greater is primarily we take focused potential in some merit liver sensitivity,

on preclinical have IVAD We a parameters. may positive inhibitors show these that impact have clinical and data

other or potentially exposure that with Additionally, reducing elobixibat dosing is medicines is risk systemic products. once-daily showing a cardiovascular medicine oral for disease aligned minimal NASH

its Finally, our with which X,XXX safety profile. elobixibat exposures, than database of a has strengthens safety more understanding

research NASH effects. most from significant to them While and of become U.S., the evidence result cause the leading die could reducing elimination projected has major contributors cholesterol the is to the maybe is elevated and shown complications. to of in disease liver bile There cardiovascular that NAFL of in in acids the the liver of clinical that some the patients transplants body

a We elobixibat move to in X into excited in Phase QX. are trial therefore NASH

The these hope compounds are detail allocate intention the of with a potential a to to to accelerate NASH through the partnering. additional is we progress later decision made addition, delighted resources at have compounds value more to create company date. We preclinical the development. for In on our of and probably their additional provide

more in in new AXXXX the will now and resources multiple accelerating we As acid malabsorption. NASH, preclinical compounds resources we are be reallocating from bile compounds warrant

the been believe malabsorption development U.S. first remain As become potential pending. of to drug acid in we on issuance has we certain treat to have further approved gated But previously the which guided, has the patents AXXXX bile

our AXXXX confident in into are delayed these will with trial patents will NASH. have initiation but on resources XXXX activities focus issue, We our and and

Albireo summary, momentum a historic our build was XXXX which in year on coming execute we for XXXX. in and into plan So

We transformative expect a for XXXX year Albireo. be to

anticipation Simon? we broader Phase hand and or to major the and my pipeline, over step While of the a to elobixibat for of atresia preclinical end including pleasure biliary X AXXXX in also it to XXXX, plan Simon, year results it’s with update. in advance our we take line in at our top NASH. forward trial compounds financial you early our

Simon Harford

Thank you, Ron.

year December compared full the financial closed the me at ended the to quarter of $XXX.X for December quickly and cash results our $XX.X end We balance of in cash fourth highlight XXXX. with million XXXX. XX, a million Let equivalents

our Our reduced cash PFIC million of quarter fourth as trial primarily by result X a Phase for AXXXX. $X.X balance was the during

the in the to $XX.X nominal related constipation revenue Our EA chronic million XXXX million same EA for Pharma was $X.X elobixibat as from payment revenue period ended last earlier Japan revenue the approval year in to of $XX.X for since received the to was Pharma milestone royalty from the in of well revenue compared year. due for Higher as received year elobixibat million approval.

and expense As in income recall, are Japan forward. continue royalty the may milestone partners. we which monetized non-cash reporting the by is interest royalty sales with royalty offset revenue healthcare you revenue we will going that Therefore the statement in

incurred development our were the costs development associated preclinical Our trial $XX.X and expenses we activities with the XXXX. to million ended compared as were research development NASH. expenses in headcount Higher same strategy of XXXX, including for XX, year December driven associated in with primarily R&D and by for full X costs our manufacturing costs period Phase clinical AXXXX million implement work and primarily of PFIC. for $XX

million a XXXX we based Our trial full our Total AXXXX the year for range XXXX progress PFIC for to period our as net the and ended expenses Based $X.XX including XXXX, million, expenses the Phase December million plans be to to and of recruitment $XX.X period in G&A full $XX of loss costs funding expenses strategy. $XX.X make share XXXX. to million, we our or by as and anticipate well the clinical in Net $XX $XX.X XX.X%, well current with for were loss same million execution total slightly of million, of $XX.X $XX in expenses of increased continued operating expenses in driven million above loss expenses development the million priorities same compensation for of $XX.X G&A attributable $XX to was as year $X.XX increases the our of million per our high per biliary clinical the were the for share was the XX, end G&A our on stock headcount principally total compared XXXX. and full to related R&D between atresia compared NASH. for guidance for other X to as costs. primarily operating as expenses year

to cash let to for clinical under we cash, to with be operating development. turn expect current In closing the remarks. meet me our to terms over And back of call balance requirements for sufficient XXXX our our into continued plan current that, Ron

Ron Cooper

Great. Thank you, Simon.

So transformational. year truly will to this be summarize, we expect

are our that from leveraged promise life We therapies to commitment show as and that potentially fortune in to devastating liver we compelling changing science bile patients our acid continued diseases. assets forward novel and bring suffering move modulation to GI have

So with Operator? we will questions. open that, call to the

Operator

Thank you.

first We question-and-answer proceed line comes a of with from with will Eun your [Operator now the question. Yang conducting Jefferies. question be Instructions] Our session. Please

Eun Yang

biliary have I a you. Thank question on atresia.

patients, why the you ever percent to have are a and in reconstruction kind biliary such So seen if duct in actually about efficacy on X, biliary patients atresia of can patients and over are you you trials, you there I surgery what XX you surgery? patients also call focusing have so the who you. undergone undergo Thank the your of Page think

Ron Cooper

Eun. very Good, questioning. much Thanks your to

first all a into stepping trial are pretty in think will announce that of we atresia. I excited be we to biliary that

serum has of becoming that expansion we show thinking PFIC I Phase are in have We and in are a some you of you with to the within thoughts and drug always the liver little strategy cholestatic upon biliary Pat, bile good And effects the talked start where good referred are expand. patients important for based improvements pruritus. study about disease our atresia, handful we on pediatric we and results about able want of? a showed been in had well. Phase AXXXX as more and we to to improvements to talk think to acids X X patient kind population our AXXXX, always bit

Patrick Horn

Yes.

specifically in that that we the a so so same Phase bile at meeting there, in poster and in in And the have the data we ESO upcoming saw pruritus general, be atresia decrease a will acid. saw biliary and but the addresses study, to in results and a our are that going terms we population of with in decrease we saw other X actually that

portoenterostomy. In terms are absolutely so biliary you immediately of atresia the right, the diagnosed they are when with patients population for Kasai echo

to they try cell. reestablish blood So

we procedure. post study do, be So will in in this patients Kasai we that

Ron Cooper

Eun. question, for Thanks

Operator

you. Thank

with Our next question comes with proceed William from the line of Blair. Please Katherine question. your Xu

Katherine Xu

other are is and NASH comment of bit strategy kind X company? you. forward, am why just XXXX that, applied atresia direct any the competition avoid or with I the whether wondering have morning. just etiology going good what on and curious just breakthrough just could bit for thoughts expecting little Phase is hi, data Yes, combinable? biliary you if of Alagille, Thank little a you designation design you in and think you what for indication. And agents class about it also just And data, versus most

Ron Cooper

Okay.

through. important second first indication with just We one designation yet. one the So, breakthrough, Maybe for selection thanks for good applied the NASH little if already do regulatory Katherine, have then biliary our number to and Katherine, guess, hand atresia question we about breakthrough, question bit make so Pat, we of of AXXXX the our to no, have on design. let’s will for opportunity so we sure and a the morning, over around I chose I in we will I breakthrough all, probably not have start a of first – as badges.

fast and and X frankly quite know and process Europe which have as been the has track a us. States U.S. us fantastic with well you speedier we orphan have in as hopefully agency designations United allows So in we

have enjoyed dialogue helpful forth have really and good We and appropriate. back a they been really and

atresia, would forward, talk So biliary our going anticipate we about that of selection Pat?

Patrick Horn

Yes.

So, at and possibilities. need [indiscernible] that atresia fastest some in We are the really look ones there population. progresses we Alagille also Right of absolutely therapy rapidly patient like it’s as biliary look is when you have huge medical no among population. we the medical very at the atresia are the and PBC biliary that for is truly right, any now, of there unmet of disease it and PSC it, other them

So post year’s population. strong is presented last just there possibility need, decreased even of There medical bile that some biliary function. liver data atresia, in can terms where in acids liver to where unmet at that build meeting real elevated a to lead is

population into is one we think are us from is I feasibility in patient also factor. study considering another also going and of It terms does it. Alagille certainly certainly size exclude

discussions real population with a in about need. indications expressed in the the FDA real unmet a is trial other an the since enthusiasm atresia our is having One biliary of they this

we But as need we again can’t to, the to stay just be So start we clearly possible, big will our as to indications expand so hope need quickly first programs to but resources predominantly people at resources biliary other into from atresia one. time. same we

Ron Cooper

that developing summarize diseases. committed pediatric So think to liver across we cholestatic I Katherine, just multiple one, overall to are a AXXXX

biliary the to Our comfortable perspective. been advocacy work really obviously work trying work the with understand leaders, atresia of with pretty has and this confident really get approach I that we with. the think with to the key with that one in are design we And trial disease opinion regulators deeply, feel case patient with from

of cholestatic to well. NASH those talk want the our will to do pediatric intent program. liver some as to you little time We guided a over the is as chip have And away diseases. continue about other evaluate bit we Pat And

Patrick Horn

Yes.

with and or in it going patients point and cholesterol. in be study is we end NASH are going be population going liver syndrome are insulin sensitivity this changed LDL NAFLD Phase for standard is The as Obviously markers X our the at study is NASH primary pretty is to metabolic cholesterol. a Phase really to It’s the is So, study. Phase FDA either meets new and Ron that NASH in look and fat to applicable guidance mentioned X a NAFLD. studies other such that X

Ron Cooper

Pat. So Katherine thank – you,

have and be previously out that concept the we indicate think NASH. the of previously of guidance Phase and has guided that we study good similar this study about As proof would X study we with to effects things about consistent put a the as FDA on the talked

questions much your of all very got we hope I Katherine. them. you Thank So for

Operator

Thank you.

Our line with Capital proceed your question. Rahimi Yasmeen comes Please of the next with ROTH Partners. question from

Unidentified Analyst

good you you everyone, end can Katie on have points will regarding is be you us think any additional and Yasmeen biliary This do faster about and size, Hi few design how questions enroll, provide morning. for than can for PFIC? the enroll be I today. primary atresia, think easy a with the I first pivotal you or to it guess difficult will describe study to it color

Ron Cooper

love want about regulatory in how for very to about enthusiasm Thanks for authorities. information with Hi really plan think are us design you much Katie. still pleased in for provide the at study of bit probably we months. recruitment? question. more time, talk we But expressed a discussions the and to to this a be talk Pat, that we our because about Good maybe the morning. little the we regulatory are plan the able for little coming atresia. early to in trial biliary And It’s about our

Patrick Horn

Yes.

patients population population faster. would atresia the is we so and biliary able to larger So being the enroll anticipate

of how in final study the will the design. upon this need the ultimately ultimately recruit think and study patients we number we of length sites many depend I

Ron Cooper

Yes.

that these that births procedure. case because in are as think we other I upon are dependent thing also patients well study undergo the so are that Kasai newborns Katie, this in the

study. our to of on with our to ability we forward staff as the the more confident Katie. discussions pretty So finalize you bit regulators. recruit providing We feel look detail a little this we Thanks

Unidentified Analyst

Okay.

[indiscernible] similar of patients and one it more do not to improve Kasai liver you found consortium percent procedures percentage with you needed PFIC be what what responders the in many are couple reduction bile and performed a to – are be of patients? Just outcome, follow-up, will how what think the acid will annually

Patrick Horn

Yes.

Pat again. is this So

average are number at projected have States, are So we we in is one XX of year. the numbers. of the and United patients the have looking patients anticipate XX Network a at Kasai the atresia per in that the of the we biliary at United look feasibility which We States, looking and Children’s leading centers if is you consortium hepatology kind would they on

population It trying So we there. then. prevalence number to Europe that are same overall will has expand and means the about that into also the be that what

So What other of the question? question. first part the the was was that

Unidentified Analyst

reduction The percentage to liver improve of needed bile acid outcome?

Patrick Horn

acids, obviously same. yet. again remains degree something reduction determine able with be what So to that will We in would show mechanism will action of a our be being have serum to anticipate we to be significant required bile

Unidentified Analyst

Okay. Thank guys so you much.

Patrick Horn

Katie. Thanks,

Operator

Thank you.

with next comes question the Arce H.C. Wainwright. with from Ed proceed Our your question. of line Please

Ed Arce

Good and guys. and Hi, progress. morning all recent thanks my the for congrats questions taking on

questions been but of my asked, have already others. I a Some have couple

early as First, you pivotal perhaps preparations Ron as some look have as in of terms PFIC. this for year, a begun on know touched I commercial early upon now readiness that of end read-out the had towards

you us you that. are had so would the of And see and mentioned this in you and of particularly NASH keeping for what compounds best could that you what to the share could how combinations. for expand pretty preclinical terms potential prepare doing, but excited then in with And terms some are what with of about perhaps you year close some in imagine secondarily, also planning differences little bit your I are you throughout a to about now, you pretty potential for it elobixibat so

combination terms in much. that today. strategies NASH is Thank of Of so course, everyone you for thinking about

Ron Cooper

Thanks questions, Ed. for great. the Yes,

from when an people think becoming world develop pivot an was And where are now organization that significant we I are into we around starting organization products of the have discovery I we things that to in the are organization we the was in that those of one comments the organization. parried think organization the a to organization prepared some that made commercial commercializing I successfully. think experience I that brought my went that

successfully So, of others our what’s I to from products launch in significance. is think needed different understanding

You He huge GSK. CFO many world. that, in approach Abbott Global Pat multiple the geographic areas. spent and years in Simon roles multiple of years was so therapeutic with might recall Medicines a has and Myers spent has Web the both many years business, Squibb the Bristol put had Lily with around in commercial I

do pivot that we then is trying to So, that ensure organization sure are a activities they the first of our to And things precommercial that all we things now and invest hire for launch. appropriate calls successful are making limiting right are individuals. that budget rate in

are So plan. commercialization types things that strategy, we through are sure making in things we like the of banging involved is brand

our more the on market market front, starting access to need stakeholders. support market be We both key research advocacy and active through on from the patient active front the are seeking the understanding more and deepening our

work well pretty excited [indiscernible]. that we I are all the that as regulatory then that. So, the we about work And appropriate, so the product follow ensure as think underneath of to

I to multiple think extends excited bile decades compounds. year perspective. And The going in I our I a expertise it’s So a pretty from as about big preclinical am pre-commercialization then said be acids. in organization

important entities. strength the new agents. they overall of product they of of are we bile a our IP in modulation. with that are about And And have And and year and portfolio is associated off study. They that. that as we acid we platform an new really of before talked have you chemical the These hopeful bile are more will have that acid progresses These platform on we will products new have give our X are a this field that AXXXX indicated color of Phase the We to understanding validation action. that the I is a mechanism them. different with be part as excited of elobixibat think hope

Ed Arce

Alright. Thank you.

Operator

you. Thank

question. with Company. of and Please question your Baral next the comes with from proceed Cowen Our Ritu line

Ritu Baral

drugs go little Good of for Thanks them And think moving partnership one think on for versus you a or could value potential yourself. interpret this? taking also morning one into you hear forward your of Did them, your the preclinical strategy it question. evaluating partnership you about and the how everyone. correctly any partnership some potential comments timing my for that for strategies are bit creation about of I about NASH candidates you your of that as or –

Ron Cooper

morning Yes. very the Ritu. Thanks for Good much question.

I to overall strategy. with think our just backup, it starts corporate

So our ability company rest is in a and pediatric to plan the We world liver AXXXX. for the use partners back and in build Europe of of intent commercialize and to around U.S. expertise. the we the our the credible how And that’s are have do to build that’s that are we we to and that. in where going the believe company I that on

a having Pharma our the that to do EA elobixibat. Eisai-Ajinomoto non-dilutive provide like though demonstrates ability partners good stream to that of in pretty for our good of clear – pretty sign Pharma, investor capital we our with really agreement been always have would We Japan a to

timing we pretty cholestatic that exciting them. So compound disease much think seek outside I is with our intent for in when upon about will goes think we of is footprint have the our what’s think I of partnerships our I And part pediatric are data. liver those dependent products nicely But products beautiful NASH, I low products, what’s other it’s exposure, said potential as earlier. NASH them in result it what systemic with currently in right. nicely co-travels right, quite co-travels very other a day is These to and once cardiovascular product, my risk a with agents about comments elobixibat, back that

our well. compounds anticipate pre-clinical similar And as something so we for would

of be of summarize, to for liver strategy disease the cholestatic through organization can through the organization pediatric just of the So partnerships. capital other our build generate products the AXXXX, non-dilutive to good on back some

Ritu Baral

before be creation Ron can necessarily NASH, data? reached think value optimal biopsy In you that generated do

Ron Cooper

really the upon it’s think assets. the upon partner dependent I and Ritu dependent

continued So to we generating data. work hard in

We have ongoing had discussions. some nice dialogue with some potential partners,

the going going and generate to see is we where takes some to then we think data thing one that I number are are us.

Ritu Baral

on is in follow-up your are a you have sites feel how that the of and Got final trial have PEDFIC I you reached expectations? number that sites, the your got going meeting enrollment guys conduct, do it. up

Ron Cooper

Yes.

XX we XX so progressing. have in is that sites will are that so So finishing of sites, trial that And of there help few us. up, we of handful our sites we have a enrollment, targets sort reached and those, enrollment right still is to and guided terms still activation our

year. We the are reiterate top far. by for We what’s end pleased thus plan our with would results just line early of year, next occurred that this

Ritu Baral

atresia to Got specifically you are how that moving indications, pharmacoeconomic burden biliary I PFIC, of you it. pricing down as drug and thoughts have it’s if you and any that I what am of wondering burden commercializing the one disease do then guess for sort And two comparing it to for just and the well? on that view how line, and preliminary impact if might two Alagille mean could diseases those

Ron Cooper

in I cholestatic cases yes, population the we’ve thanks no These burden liver have pediatric of I or it’s atresia, they in guided that currently terrible drug Yes, biliary Most there between Yes, are XX,XXX is suffering Alagille question. diseases. think available. diseases overall children And sleep, bile patient don’t right – is think XX,XXX they pleuritis, for the they’ve don’t elevated these PFIC they that across to or U.S. is that board. grow. significant Whether acids, PSC, with Europe.

this of situation right, drug. case, these a in there’s in differences homogeneous think seriousness, there’s while I no diseases, So, other lot

think both on both I very rare, versus have PFIC, a And burden biliary atresia the are about high patients. when we so family the and that think

we data as we we being dependent current dependent upon So, generate group as about homogeneous think And highly is and that these it’s more it forward. but I the label I this highly we thinking with – go a terms obviously think that in upon a pricing group comes a that is when think from perspective. have, comparable the our versus heterogeneous pricing

Ritu Baral

appreciate And helpful. your patience. Very last question,

NASH study number have run a making you you’re patients. you you about sure there and specific about mix, as NAFLD that and Is As strategically potentially study? that NASH think of thinking NASH certain enrolling both a your patients

Ron Cooper

Yes, so thanks, Ritu.

it is study sense consistent given a given a think proof-of-concept like. we’ve before, perspective. something has to think as said of we study It’s going a look that guidance of and as FDA with – that think the of as you that’s from it what I

yet in haven’t We all the study. details that given

bit So, little you we QX, finalize give that color as in on we’ll a income that. more going

Ritu Baral

all taking for the Thanks questions. enough. Fair

Ron Cooper

you, thank Ritu. Yes,

Operator

Thank you.

Please comes Our line Liana the question. Wedbush Securities. question next your Moussatos with of from proceed with

Liana Moussatos

you. Thank

could about on PSC breakthrough, potentially mentioned selection not You expanding breakthrough What about for monetize your following And get in then XXXX Alagille, indications. AXXXX a indication or since thoughts into voucher XXXX why with next other Katherine’s up others? the it? and you apply for in question are

Ron Cooper

I with start question. the second So,

hardly Liana, Just thank was the given first all, off AXXXX and from Start FDA. of the to designation you, product is – remind morning. been you for priority with voucher our questions good review for

little finalizing focused good a perhaps that’s pretty about for that we’re and over information, our opportunity of sort think the of we I an show liver is a comfortable of is really we sort in is, agency on of And rationale that AXXXX really the are comp we frankly to the So, the populations have to want of that unreasonable true We sure now time. to ability that to can don’t make a these we fair information, in significant patient approach there feel and in Pat bits rest that effect that of and with we but takes we’ll believe terms And about work AXXXX cholestatic together our and AXXXX. continue protocol the the really diseases, in where selection right diseases, of diseases. that’s of multiple get get then are these pediatric taking trying breakthrough, bit over time. we trials across question, put the capture value – of creating team believe question the that we’ll but ultra-orphan

enjoyed had about the need we’ve an unmet as unmet with super because pretty earlier, a Pat a opportunity. with wonderful So, that diseases. first discussion in went this as well. There key are with recognized agencies quite atresia trial dialog ongoing on it’s with this medical we need patients biliary significant have And basically high. advocates leaders, designs patient these really this because We other opinion they indicated is few a is for actually

biliary to So, I with same where think that’s to atresia comply with other – potential are criteria diseases. this we the the

Liana Moussatos

you. Thank

Operator

you. Thank

of Please Our Needham your next Carr Alan the with comes and question. Company. line with from proceed question

Alan Carr

Hi, them. thanks couple of and questions, for taking my

straight So, do Thanks. is and commercial Phase for about atresia, think about bit to you start X also I going X opposed something Phase building before? what to more that want at aggressively might organization, you you to then in rationale point more talk a to do a Phase that after is as X a a maybe running biliary or larger

Ron Cooper

the on Let things. me the of second start aspects commercial question with

is focus we’re to has in negatives is think successful key to getting is there, being component, find a one, way – don’t a commercial not that we’re that’s what’s launch the to there activities, we think rate-limiting to right. that making there’s missing too done or launch around in what is our – I be got ourselves so double as our I really about want sure that nothing pre-commercial it’s now. really is many so towards so planning

obviously, the our we’ll to readout for we we data perspective data the approval closer get and accelerating and when start regulatory from Now, AXXXX the then readout put efforts. card file as

to into an so things And Pat, we’re as very the as pathway. careful regulatory commercial the like and of it not we in right presents things focused maybe should get us. such of question. way INN not think picture, rate-limiting take you be are as deployment resources, – on think out our the brand we’ll itself operations as I are, issues data issue the are planning, careful and to the for that just sure name about accelerate first name now making Those summarize,

Patrick Horn

Yes.

clinical of always it’s programs rare terms in diseases, in development to proceed. in how So, a decision difficult

are looking rationale atresia, AXXXX a should strong there. we’re why So, be some scientific at benefit biliary there

X all is to moving support be some of We said, and I Phase going that our that in have study forward. data data like presented previous

demonstrate we did only considered study regulatory the study that be not efficacy AXXXX a application. And So, what designing the prove AXXXX, if was, agencies, support really we the pivotal designed of efficacy atresia. a of a in registration in with will will successful this that study we but biliary the discussion are to

worlds. So, the partly And it’s studies kind longer relatively in indication. because rare study of the that’s even of are than diseases, these a small both best in different a

to So, that regulatory were if willing I it’s very application. pleased and the positive agencies have a we regulatory this study that work with support think were

Alan Carr

taking questions. my Great. for Thanks

Ron Cooper

Alan. you, Thank

Operator

you. Thank

Thalmann. Matt the Kaplan proceed question Ladenburg question. your Our from next of Please comes with with line

Matt Kaplan

of foot Hey follow-up Good BA little nor guys. just terms kind of of you’re what the questions, morning. in data about Couple you you’re kind timeline view, study thinking successful? the bit of pivotal if a us of thinking but from to can program, a this the XX,XXX more program, into the potential obviously, potential of for half NDA year, understand help it’s and in launching timeline the filing second us give kind

Ron Cooper

Thanks much question. Yes, good morning, Matt. very the for

think from biliary is cholestatic I AXXXX into disease need. excited that we’re PFIC major to to and with it the that unmet medical you pediatric from wanted atresia just we introduce liver other particularly this potential being morning, a huge about diseases expanding

the guidance finalize we’ve regulatory the discussions We’re still in we’ll protocol, second given of so, the year. with half that study the start authorities to in this

premature So, over now make probably I the we that can us to me regulatory up the be authorities then time. probably comment, it’d for but let with further finish think discussion move

Matt Kaplan

your just bit the that the plans, give that could the would could pediatric us liver on also commercial area, go the disease organization size terms need of Okay, like? look of you to cholestatic of sense fair little you of enough. it on a after commercialization kind And focus in what a then

Ron Cooper

Sure.

base starts right. with it like, that look think customer I what is the

about very that Europe, X,XXX it key need pediatric the of orders force each say is centers, tertiary magnitude as let’s that would at them, individuals probably of prescribers are a large potential, right, teaching and in about against other think to And So, so well. the we most XXX a individuals there think U.S. in center, another deploy these so right. be field not might and hepatologists of there significant you

U.S. the diseases, And both same So, remember it XX these of to some or and of individuals, for for right. prescribers the liver are these that Europe think along between for all to cholestatic XX the somewhere are remember deployed field individuals. XX lines –

lot patients, So, the the the there’s patients biliary of a hepatologist PFIC the sees at over synergy eligible patients, so pediatric atresia time. separate,

Matt Kaplan

is strategy, a a NASH into of that to X compounds respect then moving data do pre-clinical putting and elobixibat on next-generation – and with fully to point partner? there How proof-of-concept last and you are pre-clinical NASH with so programs fit view strategy – of That’s your that Phase just molecules. forward stage good. to with bring stage and question with development – commercial the elobixibat and view next your for the to is kind very Okay, from minute helpful. And jumping just back they earlier it developing sidelines of your your understand to elobixibat bring you’ll or a it point potentially you

Ron Cooper

Matt. Yes, great a question, it’s

with significant that a compound. exposures, it so understand exposures space in we about we the have well-characterized confident over are – NASH we given of the level very starts I think elobixibat compound, that X,XXX

compounds, moving pre-clinical the less a in the forward risk so, as differences than still so trying And we’re there’s to understand, some somewhat that. result, is which

think go I going strategy generate. really our the what is what’s with we forward data partnership to how determine we

deal best it’s premature potential the so the compounds, that see how partners that speculate exactly we’ll think what from perspective. both data, think let’s continue dialog plan but as And I to is, our and with I works probably to the let’s again we with generate

Matt Kaplan

EA’s in hands it elobixibat, how Okay, just very good. then in is performing Japan? now question, approval And following last

Ron Cooper

chronic of elobixibat, secretions new launched as an a action, product, on And what’s has has Yes, in second it because it with it special the about They’ve our CIC so, fantastic. effect was elobixibat, the both is is shared well, generation ability was about enthusiasm Matt, being constipation unique nice impressive. late say Japan. a motility to market to well. but in of satisfaction bring and colon, into the I the it thanks have that levels, research partners as I for mechanism thing pretty Japan some year question last The products

early. with to so as the still relatively uptake. other and sales, remain patients result, remain that Japanese well. think around responded a had medications That pleased partners the potential seems optimistic half And – pretty it half it’s had year They but of being And they of done pretty they pretty in that our Japan. pretty said, year I are not only have elobixibat sales we’re optimistic for

Matt Kaplan

on Great. taking Well, the thanks congrats for questions. the progress and

Ron Cooper

Yes, much, Matt. very thanks

Operator

Thank you.

Arce Ed H.C. from follow-up a your question. Please with Wainwright. is question next Our proceed with

Ed Arce

Hi, Ron, thanks for taking the follow-up.

unmet mentioned approved just group cholestatic a similar, the the each of there��s these they diseases. and concentrated even call, be through at as therapies the you’ve thinking the these as that this pediatric you in of of you similarities high are pricing commercial into this mentioned largely just at need, treatment centers lot to mentioned. no pretty least for given was medical times rare I several And So, and would a perspective, from seem point

the announcement you’re decision? or the Alagille faster larger I your noticed that of What Thanks. going it’s second than So, BA mentioned? all led as the indication other – for much your I led unveiling sort if one for ones. you it bigger that and some of Is Is there’s PSC? you think What about versus for exactly significantly more to this that where or is deciding factor the population? enrollment exactly you factors AXXXX. today it

Ron Cooper

Yes, the follow-up question. for Ed, thanks,

have right one and need, the alluded things babies and are have them, medical all, led BA, not it’s after the These that is, thing, now. earlier, quickly it’s we’ve first multiple born think treatment procedure Kasai no that think about and we of us life to things to I to come have unmet but that are very right. of some

in talked something So talked we to we us to space. pretty And the and think people need. as both opinion key to significant do unmet this I regulators, medical leaders want

first the that’s think thing. I So,

really size And as large thing indication a is is, you And of together part really to a build a time and perspective second third team illogical The and from we’re what and a this spent so pieces of very think disease amount the I pediatric out, pointed of with it’s have put we’re product, Pat patient then to we I make significant. AXXXX about disease to with trying pretty insight. pretty think big key do happening have deep small where insight to could impact. understand his considerable advocates for the point information and I an the into indication. not what’s commercial you at liver the GI trying start leaders and if opportunity the with think scientific to where opinion disease AXXXX, of is look cholestatic next this our

biliary opportunity, the go is with our background, I reasons being to diseases That this why So, and focused on forward intent liver we cholestatic work at we’ll need, for point. that of and what’s from think those are with we size criteria – other we’re atresia this perspective, question, the to said, in three as on unmet then forward. continue do feel those going same but we when a size Thanks on handle we’ll again Ed. go well, a against good on time, over those use the have the

Ed Arce

great. That’s

Operator

Thank you.

call over Cooper Mr. the closing any We turn question-and-answer our I would to have for back session. end the remarks. reached like to of

Ron Cooper

everybody. Michele, you, Thanks, thank and Great.

against to So, delivered saw We’ve you what our XXXX. you hope summarize, had think I commitments. – really that we a I strong

AXXXX beginning NASH. a with with and plan major upcoming Albireo for and We forward expect progress in trial of we the the with step period to truly atresia the biliary a be transformational continued PFIC,

thank So for you today. a joining Have good us all again, day.

Operator

This Thank teleconference. today’s concludes you.

Thank you a have for this may and disconnect wonderful time. day. your participation, at lines You your

Albireo Pharma (ALBO) 7 Mar 192018 Q4 Earnings call transcript