ALBO - Earnings call transcript Q1 2018

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Operator

Greetings and welcome to Albireo’s First Quarter 2018 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions].

As a reminder this conference is being recorded. to conference like Arndt. to now would turn over the Paul I you begin. Sir, may

Paul Arndt

Company’s operator accessible everyone. a for an The Thank joining good a financial of and you morning results Albireo today, accomplishment via during performance the release website issued management press and XXXX. Albireo’s its Earlier today’s release at Thank quarter. which will business www.albireopharma.com. on the provide highlighting the first update press in is beginning recent call for you noting

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

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

Ron Cooper

quest intrahepatic in Paul milestone the Medical PFIC conference Financial families their today With a you PFIC first achieved a is familial is well everybody major thank PFIC. Chief cholestasis Albireo Tom in forward Chief or Officer. a for Soni, as X Phase our progressive our me as major with Thank and and call. X to Albireo's treatment clinical and Paresh recently you for Officer in medical step our living people trial company. This joining to new patient enrolling bring Shea, today's

will label X blind Phase wonderful our double delivering for trial PFIC and multicenter randomized single I'm study at team clinical enroll and We Phase responder spring a to for controlled trial change this a FDA an a acid evaluation. accomplishment evaluation to or placebo the XX for serum serve trial The The safety includes as controlled for of extension long-term in and guidance durability will open X the for secondary key evaluation. our type approximately with of bile primary price EMA X The placebo XX designed endpoint Albireo and excited for type are AXXXX primary weeks. program as endpoint patients and initiation. XXXX evaluate key FDA The proud of endpoint very evaluation doses response. endpoint a assess and rate X on will secondary of serve two EMA

X prognosis Also difference did ESPGHAN P biliary the surgery appear serum has EDPGHAN bilirubin the external biliary liver life. Meeting of in were qualitative during of be to to demonstrated trial a we review, and PFIC. new substantial systematic in liver, for in of that used study for for for with of [ph] meeting. generated to and was expeditiously ataxin X.XXX AXXXX applications in expect a diseases study trial that our show clinical Phase us history implicated analysis X autotaxin cholestatic our on patient its of in positive benefit there Our reported form world. an and on the Phase data patients a were from independent team in or in can the presented particularly U.S. the the candidate around evaluate We patients independent We biliary into for diversion evidence progress These X outcome found Study of we pruritus. effect potential for biomarkers the literature be observer at a patients of research of diversion findings of currently study partial NAPPED Society to place patients liver value to group study. agent and to PFIC therapeutic and study early Phase and data an data changes diseases the long-term working a and NAPD predicting was pediatric European from EU European generate survival that priority use to Liver, natural will diseases. plus not. support the It's Gastroenterology, both it data between PFIC serum the an data tools information EASL native is early continues AXXXX who consortium intend PFIC. disclosed long-term for outcomes is have history pruritus. our for potential from of with Also exploratory PFIC to PFIC. the to AXXXX and children and reduction Pediatric treatment with the and was insight acid The an in quality cholestatic in and XXst have be support useful The primary in and become the and anticipate pruritus These X correlations is available historical XXXX. cholestatic bile in EDPGHAN Phase observed from from decrease the We with pooling is the around acid treatment that who supported first and Phase additional of approval has development drug to presented additional use. should statistically presented by PFIC believe physicians study at Hepatology, that proprietary Association Nutrition very in study. with surgery X or come At beyond in of are and study and X as were or there a interim the course also versus of pediatric those the as PEBD we with is given of a provide serum a The EASL natural bile our in PRO that end work significant outcome expected measure and characterize levels, believe This all patient our previously XXXX be pruritus the for the X from sites potential the known disease useful expanded or of X may other reduction available Interim AXXXX ORO PFIC cholestatic impact analyzing trial where this PFIC that reported and to mechanism acids the product activate We to data that extension the liver presented bile and or in data between were data types the disease that such correlation natural international the biomarkers. grant liver encouraging Abireo. had been PFIC association

first the received for Let EA quarter me now we inhibitor chronic the in IBAT to elobixibat Japan first approved announced elobixibat. constipation. move treatment for of licensee In world's regulatory our that approval the Pharma

the royalty approval. the of The healthcare this us approval under $XX agreement to us. and under agreement XXX% our announced prior eligible we are milestone approval had investment to paid million more elobixibat license triggered Just monetize EA healthcare healthcare maximum we amount the million payments Healthcare regain Japan Partners to Pharma healthcare the Pharma receives and under firm, EA royalty leading with between Moreover royalty $XX of an Pharma we EA reached. on a agreement, specified with is if in agreement eligibility our royalty for to our amount to sales additional rights royalty Royalty for than Japanese an

more significantly, world. IBAT the an elobixibat the of perhaps anywhere approval first inhibitor Now of approval in the was

another platform. studies the well of a impact with novel liver NASH and findings makings parameters have potential impact of Our to further scientists a is AXXXX and IBAT now platform with as the modulators. Phase that bile indicate NASH Therefore or NASH With on inhibitors decades protective which resistance resistance, have acid as shown been in two are elobixibat inflammation different impact indicate with preclinical inhibitor in We're provides Speaking a X this a be taking to this the two of NASH beneficial a the acid fibrosis. acid and to bile preclinical approach IBAT potential elobixibat X the elobixibat modulators we on of the Phase preclinical of our has bile trial findings program. Albireo compelling elevated and initiating acids patients for includes couple program liver comes modulation cholesterol study of considering a elevated that Nonalcoholic working with XXXX. elobixibat with LDL been bile first of that have of liver been acid and cholesterol, a inhibitor indicated fibrosis. pronged believe of approval IBAT we have Steatohepatitis levels, validation approach potential half Clinical bile on we models. insulin Also pronged GLP-X linked a elevated insulin preclinical of a and inflammation, have NASH from potential

it BAM. to If limitations Cholestyramine related as known or to the United of clinic issue the first States, by candidate Our releasing If third approval designed would States. AXXXX clinical overcome success into obtain start AXXXX the trial considering directly we stage treatment in to to formulation able bile acid colon in in our we an treatment proprietary decide is acid AXXXX XXXX. sequestrant of bile the the that BAM. optimized If it are taking so could for bile a be achieve we in do formulation evaluate product the approved for an for pending we as United claim the the acid AXXXX malabsorption is expect treat formulations patents a established the malabsorption to to are regulatory half and first in

collectively totaled non-dilutive In just Albireo these on proceeds XXXX, as requirements its XX, Based in pipeline. for provided million and be December current an increase with at at million Lastly cash from of financing an strengthened sufficient solid on million. cash $XX meet and plans transactions to our resources in March expects funded operating QX foundation execute XXXX into position equity $XX XXXX. to XX.X compared plans. million additional and Cash over a this that raised our million XXX.X financial and current its of we're we equivalents has least net operating XX, XXX.X will well

PFIC trial tremendously hope excited families. summarize, So and PFIC underway to people be to to with X we bringing X their are with Phase the

Japan in to chronic first for are approved pleased IBAT now We also constipation. worldwide have inhibitor launched the

data advancing take pipeline other might CMO we our questions deep remind I'll are PFIC you We CFO liver to Paresh on Shea, I'm you cholestatic Soni, that offering we beyond. Tom that be focused and continue happy and insight here to would any have. Operator. present and into diseases into with and

Operator

[Operator Instructions].

Ritu Baral question proceed. Company. and from first is Please with Our Cowen

Ritu Baral

they sequential is about commercial thinking morning a placebo in Ron, thanks Good for taking do that think you for question. figure in guys, place are doses the both plan, the you do one the dose is Phase X, both stat the doses and might analysis? them clinical how versus two into how it primary of be there and or PFIC a analysis

Ron Cooper

for Ritu, the very question. Hi thanks much

our a big success. two think of one the we for it's that think doses us but I was decision increased probability think I

only with intention go that one we feel per kilogram. probably Our it's and to forward is actually to so microgram we commercialize the dose plan XXX

doses with two the studied have that the were actually the within doses we how is XX go and that doses, lower So reason we XXX surprised X. And within that had. we efficacy are to Phase decided doses with we the two much we

So, of it you dose really want a about is talk analysis. second to Paresh have a bit plan backup to dose. the

Paresh Soni

Ritu, Yeah for sure, thanks the hi question.

a can have the such and to we way that sequential each So not designed do testing. we have placebo program against test dose

way dose. the of intentionally that we other And primary even increase the our still So the one if we've meet does not it test endpoint to designed probability success. can of doses

Ritu Baral

I for X follow-up ask about when you're helpful at then just the you think effect X? believe thanks. Paresh, elobixibat Phase I on Very at does impact that you the you looking structuring or wanted the mechanism about hop back potential your queue primarily do and to NASH least endpoints and how for my be the how how that will you're in primarily in fibrosis on Phase thinking would the about information

Paresh Soni

improvement the studies early the improvement the of of can to that steatosis most way we we'll therapy to to compared studies Phase out, in or coming to few a liver term X a the in fat a liver of lot we tends is recent course improve significant of show if And in fibrosis. in in and can way as you've fat we a that have to inflammation we from like first fat thing get with that months want and show that that short So, that is NASH have improvement an study placebo. lead seen you in in design many

be So things the steatosis. at to intention biopsy going X look fibrosis and early show in an to we're but in not improvement Phase liver will in primary but markers fibrosis like measuring markers we is study hepatic inflammatory

said steatosis, that have NASH in reduction in GLP-X very beneficial with our that in and have all in those preclinical we've improvement for shown fibrosis. setting and are we LDL that and having several we in shown cholesterol, elobixibat the insulin setting models of in improvements inflammation, Now includes And factor increase example. metabolic resistance that

improvement but show to -- we short term these So end are obviously studies, are the that need do fibrosis. longer-term in to results in studies

Ritu Baral

rather So, PDEF that biopsy a study? like sounds study than

Paresh Soni

For early to Phase the X way we think go. that's best probably

Ritu Baral

it. Got

Ron Cooper

working through are way that still right our We now.

low but excited approach about then about non-systemic time back are potential an our modulation particularly I spending interactions and from what therapy, they a not for the injection when potential and is key for are low. them relatively safety what first things with is leaders lot drugs therapy are target getting think opinion at oral We of off other approach look we our they thinking acid are efficacy. to what that they And with bile effect,

they show get So at start we when excited Paresh of metabolic are pre-clinical the on look with said, some as inflammation fibrosis that markers pretty models about then at pretty data if we and and look about them some then that And you that. the package. of excited elobixibat has clinical to the

and that. to but those that plan some of Thanks as looks still working aspects development our the put's something foray has said early So kind our question. markers of of Paresh we're intention through the but for that at be is will or highlight first all together

Ritu Baral

helpful. that's taking Thanks Okay, for them.

Operator

proceed. Please Jefferies. with [indiscernible] is question next Our

Unidentified Analyst

Thank you.

study significance you patients each the X Phase that against about in show to XX is placebo, you if can the think so assumptions? arm So your sufficient talk introduced statistical and so powering

Paresh Soni

believe XX% published. points both and Yes, time. is question. the -- on Phase of have that's to the six serum data power improvement a change. for group a show of we from a bile data and end endpoints, thanks And we've both both hi, bit Power placebo those been work actually done month other more we So, acid difference a have the is than for in we the And an enough. show to pruritus had patients responder X treating quite

that that will So, this four and remember weeks we study be presented X longer our only Phase study. was a

have XX the We haven't But powering time we our patients in comment fact point can't and sufficient disclosed assumption overpowered so in power by confident one that at group of this with really maybe that. I even endpoint. slightly very we're on per

with very very, we're comfortable So that.

Unidentified Analyst

so secondary primary for the well so Ron the you as key mentioned endpoint each endpoint different, Europe? have then in key EU do to territory, Thank and the is you hit and in in secondary U.S. endpoint approval a

Ron Cooper

the with Thank is And think question is totality said both actually the for question. you of both be for to dialogue I to right. going the important. actually And the us data the Yu us had bigger we've authorities have authorities,

the secondary endpoints would will the NAPD patients that want years natural particularly comments So we as at time. they on and data study whatever for that I therapy extension we And which then generate history in both two and some able to but said will and as study, well the the for some [ph] least my so, we have of will have have plus submit at the be X that prepared data be to the direction group on hope us. -- primary travel Phase from also when data we for the

obviously they will the secondary, have be well. be the into part all regulatory import world -- imported important the will And answer primary to indicated regards of but as us secondary to sell think directly each question endpoints also to that go in premium aspects So your the submission. and those I are to our in point

Paresh Soni

to are that Yu, just the the of the And really add emphasizes looking to at regulators data us. totality

pruritus you gets see over the So, for that in will liver improvement raise disease worse that example obviously if question. but an time

So at more in this in direction, are they really they ultra reputation. moving see that's want the right looking what to interested in rare everything

Unidentified Analyst

-- value X.XXX? X than For the is or P secondary key secondary endpoint less

Paresh Soni

it the will be Yes, same.

Unidentified Analyst

you. thank Okay,

Operator

is Our Please with from Katherine Blair. Xu William next question proceed.

Katherine Xu

X as PFIC morning. it less about at study compared wonder because X like? including Yeah patients if X I just presented X, you're on just would take to and PFIC wondering surgery good account as the the that EASL, Phase does the look PFIC your I'm PFIC label PEBD X design had the into a respond as both the so PFIC looks AXXXX the impact then you like IBAT significantly how X how hi, patients PFIC patients X patient, to not of

Ron Cooper

Yeah, the Katherine. question thanks for

I X the go and from are feel result you you actually What the them and in as results look forms see at PEBD [ph] dialogue different you data with they think EASL if and the have PEBD and to don't interim group at you that PFIC when surgery enough interim remember to there. NAPD X look referring yet. group that there efficacy they in which presented the is the that of you X actually was that PFIC at studies in surgery is

and confident of across the forward of look feel pretty data to drug PFIC. they completing various that once So, we the will we the make effect the But types then we sufficient of AXXXX conclusions. appropriate them have study

Paresh Soni

for we also X of Katherine in PFIC X X we and imbalance that that to any study across ensure get And just an retreatment PFIC in groups group. don't the addition to

Katherine Xu

you. Thank

Ron Cooper

Katherine. question the for Thanks

Operator

Please question Capital with from Partners. next ROTH is Yasmeen Our Rahimi proceed.

Yasmeen Rahimi

criteria you congrats us have is the which so And one a guidance PFIC out a and is that considered on study, Question inclusion bit the then on X is can explore? largest second site site more is you have involves question give the questions the rolling little Phase patients? request that U.S. in to team two an minimum do morning Good on the that.

Ron Cooper

the the talk will with about and you start score. perhaps sites Paresh I So and can

the remember So where there's There to recessive PFIC world. itself clusters that tends continuity disease. is around some on be

immigration was of you in some are Europe of cutters if patients look in on in some immigration at in United some then based Northeast the particular States that then There's Middle clusters the of there there's course drives the of different countries. of clusters area population. a fair areas. East [indiscernible] some there And So so and bit in Northern the that

distribution so world. you even world result not as and some it's the that have the and then So of a distribution some spring around around clusters patients Paresh.

Paresh Soni

And and have that's of prior period Yasmeen, calculated question. the moment and a at the we change that for in some criteria that month we during don't tool unfortunate what for of But done -- publish we've patients criteria when developing determined into we randomized inclusion. by over minimum submit so getting of screening preempt the it disclose. can't patients do on on to we a we the thanks need study soon. scientific the enough detect so is. to six the work period. to Hi what And just a the bit the they that with pruritus giving But I I quite at severity have as disclosed point can we've to electronic at meeting the validating the to a for that or for beginning inclusion Yes, diary. threshold they the think and ensure pruritus hope -- and fill the a threshold have yet is I caregivers that course want that this major really and

Yasmeen Rahimi

more you on much do is natural that give play? history study have Thank very you currently logic insight and that large supposed question, that ongoing, on be reading this in XXXX, current the in to study maybe can a little update so are you one then any you bit Paresh out is us

Paresh Soni

NIDDK the have many have when disclosed our much as on not in you I detail study, has actually how and unfortunately study they done a going know it by and Yasmeen. -- patients than is So what time hope long more been any don’t they data. they release That is know it not to the for you know and

We have think that and asked on many working them are that. I they times

you three is network decisions. those know going can't this and think I moment process the as before that on years at are make renewal comment think five years through unfortunately. every really I the or up they they I for

Yasmeen Rahimi

Great, thank you so much.

Ron Cooper

Yasmeen. Thanks

Operator

is Wedbush Moussatos proceed. with question Securities. Liana next Please from Our

Liana Moussatos

you taking for do to about that six on congratulations to kind of and of of for trial questions second diseases? you us is for planning in any ages you my and safety newborn can Alagille work to months Phase liver X. Thank or the Phase or any And are work your X symptoms are pediatric thinking the The years, from group? PFIC six indication XX then months you designed kind one age remind other

Ron Cooper

the design to for comments thanks going. kind -- pretty and be are we up So the excited so Liana,

that that is the makes that's these of approved children. mechanism our think I one no for attractive things pharmacological of all first there is treatment

a for that a that have oral approach on it off it then makes we potential fact the but of top that that attractive. makes non-systemic low has So medication attractive effects target

So design we're we that's given the good feel safety about profile. and pretty treating right children, pretty, young why the

I grow begin easily. ultra symptoms with with pretty rare think in our diseases to difference present quite that patients other they they versus and life. these the they a don't disease present quite about thrive, prolific to be early They failure as present

to expect that into And years to frame the so, early see time patients six come of the in the studies. we months the

good team years our us and Phase and will careful the opinion we a three the patients. key expect you leaders. probably around that's population is our study the five know being comment patient years the look study do about. had in something indication, other that for three What promising with and X of types X four Paresh the things. we're means study patient sense of in second really that atresia be patients those if has our Anything some Phase add on pretty So, for then those Alagille to Paresh. We And liver dialogue length types just -- sub understand and we we're patient best makes want data trying a population population. patients, from what showed endpoint of to some you both to at

Paresh Soni

we way on I are the more far first in group. patient in as age not to of just will but study pediatric we X of at will It's add, mean robotic be Phase investigational starting plan Phase Yeah, to X months later the as study six a be in studying life. the year get age designed. experience the But in is event that it course of

us terms have In do they we the will and meeting will any that is be safety, of there signal if safety regularly DSMB and reviewing data, a let know.

about thought be are just have be we because sick. So we can that these we that make sure covering and that want to cautious quite to patients

So, for question. thanks the

Operator

Alan from Our and is with proceed. question next Carr Please Needham Company.

Alan Carr

similar develop at ratio rate plan or up of to in And an NASH your because enrolment in the you of of you a we over the up expect X a or from is it Thanks. X couple, your rest And parallel year around the situation? first expectations in one expect Hi, quarter of in program, a an we brought highlighted thanks quarter taking what elobixibat the X? OPEX fourth should PFIC the X either today, earlier for Phase taking second as the through and into a should have also in the also PFIC to my Phase questions and X Phase you on congratulations on but patients plans stage these terms plan is then Phase the do couple to X third starts? I start. of stay ramp are

Ron Cooper

questions Alan. the Thanks for

Tom and NASH I OPEX. about PFIC talk X and one with hand start over Paresh me will the on to close Let can and up to X then

strategy I two our think approach. a is pronged

think we have like that lucky to elobixibat has a Japan. feel been pretty approved compound in I which

And NASH. there that. going rationale modulation patient Phase acids as That a working makes behind parameters then we acid for the with bile of our given safety are pretty strong decades. us a approached into and XXXX over key platform in earlier idea been of have confident the data that pretty in have bile the the We that impact scientists couple exposures, is amount spoke tremendous that for a for known X same from we are study

elobixibat So also mash comes from compounds our AXXXX and preclinical platform. from from that that comes platform, platform, that are

And so should early early two with we actually that too comfortable how out and the But signs of to interesting see it. encouraged we will those to the are come in that us it's say preclinical will Paresh. pretty compounds I NASH what have But come we compounds. and think many overtime. makes as what from pronged something by approach

Paresh Soni

Thanks will versus X the Alan, PFIC X take PFIC question. I

at So, and academic the so And XX% have literature don't of prescribers through known X looked what's PFIC the the PFIC have to across far. why and treatment an be talked looked PFIC that the of we at we NAPD data where have consortium. study the landed is is come think what independent the ratio XX% X, the across of groups that's about out patients to the interim PFIC many that's PFIC in -- our we it'll of X. [ph] we we stratified and have partly the vast treatment And the think X majority even that and patients be based we study. on more groups. than But so will distribution obviously in we've X X And

to I hand over question. for Tom So OPEX the will

Tom Shea

the about first OPEX we the operating in quarter. Yes, expense for hi had Alan. million XX on And

for the XX year. to XX for guiding are We

So I should to we with in call QX here. anticipate line in seeing are what X do X be it

Alan Carr

NASH program. follow-up a your comments on Ron, on Thanks. the

in a to the You IBAT mechanism so to have programs and bile you or these two compounds some develop action mechanisms also earlier with different because different different thank compounds praised you? for early bring appropriate acid would face are other it stage inhibitors rather forward than picking decision point you of that be they of at IBAT have inhibitor, modulator between planning are or of parallel something action later may a the development, one

Ron Cooper

Alan. the for thanks Yeah, question

us question. is to it little a that for bit think I answer too early

space. that bit disclose little are a So line have of will the multiple we is so working I about on when what better a But the the compound, on team on. we be able teams sight of are working to potential excited we think more

Alan Carr

questions. my taking for thanks Great,

Operator

Instructions]. [Operator

Our Ladenburg Matt next from with question is Thalmann. proceed. Please Kaplan

Matthew Kaplan

Hi, good guys. morning

my on question to primary more, I Wanted that for focus your on in and major little the now? maybe secondary X sBA talk and little about bit endpoints, there about scale underway, of can the for the what obviously. to you're and more talk company components Let X magnitude Phase me pruritus of you Paresh, guess congratulations a milestone add the terms at a a a achieve to and getting bit the two looking in of pruritus also you're bile achieve little the bit hoping the serum acid change Phase

Paresh Soni

Hi and Matt, for your for comments the question. thanks

rate, so placebo. the group of in looking the for at bile we're versus acid serum proportion responder So treatment each responders

they're don't And be binary placebo And a as is to acids at So it the could and literature a at they the terms XXX this XXX achieved we in change. it and yet disclosed between somewhere classified and patients, clinical XX% PEBD if looking response a certain XX patients and looking in and acid basically we reduction more is of endpoint. a responder serum at data large are XX Or between a of bile serum than group threshold on number not. compared surgery to responder. XX% a looking a exact XXX, what it looking and constitutes bile but in haven't at numbers baseline

we and outcome In and very groups and with very the the what understand long terms overtime robust is assessment of time from and what each scale weeks change few period a screening is we daytime and between see a believe that scale FDA And daytime overtime. closely to which is there at to EMA a scale, of each, baseline a caregivers easy need sorry, developing that pruritus nighttime with the morning expert up clinical very we've patients. looking by by and worked of spent and with measurement come group and

saw none more weeks them so In four X study. of for hope change Phase XX a longer is from we responder see and much a analysis. then at we've different we from we moment baseline, course six And is we kids. than scales, months We give change we in where it is a are This long, the placebo. our change a cholestatic to think actually of were weeks over the time. be As it they're really using weeks a what showed that longer four to three is had designed doing are not stabilization will that the in going study so for so pruritus and study good us greater and a of a separation at

Ron Cooper

we X I things, great I not that X, refined, reductions what's when think know but I we a that of mentioned bile what you the Phase acids in looked think same all X Phase so point we we is in three showed And against an think in X. different are then very think them characterize right, Matt, I to Phase we measure the at we pruritus first showed Phase good and improvement scales way changing right. is Paresh's versus the

general have from So we that with if you tested look pruritus we at parents. three scales, children a a their have proprietary perspective now and it we used tool

we then well. measure and acids the certainly good to to bile in that that about sort as points, we that way the So refine serum we Paresh's dug on of feel

measure at] So in good we the being them we feel pretty both Phase endpoints [of X. in way

Matthew Kaplan

by plan how have do now you and of X about you that's you expect to helpful year-end? for Phase and up sites I have great, total in timeline Okay, of guess the in couple have follow-ups, sites many do many how how terms then little a many bit talking sites and the do to

Ron Cooper

between to be for We somewhere question thanks this anticipate for so that XX Matt. XX that [down] will study. Yeah, sites

behind we and sites up many have how disclosed and haven't it. the going We timing

that getting I aspect think study the is moving. limiting the really of rate

our in site had end pretty feasibilities. CRO have We place XXXX good done at and we've the of a

it's part administrative and right getting IRRBs, have the phase of the a all authorities, of working we things. it's through countries now idea those multiple of through But the patients contracts, is and sites good so team really multiple are. and regulatory where So going up and

Matthew Kaplan

bit you them just and I for little are AXXXX? and you Okay, I thinking but would in strategy. indication of then be for atresia guess your terms last thanks this addressed current and other And biliary other Alagille and that? about for a what's indications syndrome or AXXXX guess optimizing finalizing XXXX where update then on question formulation for

Ron Cooper

Matt. I questions think -- those for thank you

company on in that will up X much the I confident resources that guidance taken priority to think now our when And to organizational on do what big carefully we to all and our all and we background of you indications really of we've that only to sites. is little XXXX the pods cylinders guidance studies. we've that. AXXXX of burner We've AXXXX we both a with a the PFIC for the really itself driving X front X up bit the doing study more left other behind And indications. AXXXX a wide working a pretty where couple program PFIC we're characterize in and as we're But those part and to bit. anticipate with do little team the pretty the we're of clicking be you of we've largest given what smaller the in will the we working frankly a because first AXXXX half the other and activate had In to start of XXXX. are move is need

work have ready that just do gated make as of show rate against from will to events. and small endpoints. we those for us for that but what's for. that the patent the to up parts get are getting for right right those the sure AXXXX there are deeper a patent both Once we we're we to our key we trial so going well there And be looking the opinion in meantime And limiting other insights are in doing indications leaders

Matthew Kaplan

Great, lot. thanks a

Operator

Ladies the the gentlemen for would question-and-answer back have turn floor we end of and closing session. I management remarks. to reached over our like to

Ron Cooper

you operator. thank Alright

just PFIC to are So summarize excited trial PFIC hope to with with we the very their people Phase and X X families. bringing to underway be

financial world have well to to have are execute the IBAT on approved launched We in first the and delighted as the to and Japan inhibitor our resources also plan. now in

and So I questions, thank in for really you you. appreciate the all today thank tuning

Operator

Thank concludes this you, conference. today's

time. You at your participation. may disconnect this And for your you thank lines

Albireo Pharma (ALBO) 17 May 182018 Q1 Earnings call transcript