Albireo Pharma (ALBO) 16 Aug 222022 Q2 Earnings call transcript

Good afternoon, and welcome to the Albireo Pharma Second Quarter 2022 Earnings Call. [Operator Instructions]. Please note that this conference is being recorded. I will now turn the call over to your host, Hans Vitzthum, Managing Director of LifeSci Advisors. Thank you.

begin. may You

the and company's today's operator, release everyone. you is results Thank its XXXX. June Thank press at This This good www.albireopharma.com. afternoon, joining release for financial and call. business via press quarter Albireo for ended recent XX, the you, accessible accomplishments afternoon, second website issued highlighting a

Private of subsequent forward-looking and they Form or and filings. represent Before are accessed not our XX-K can to Act Securities uncertainties. be August We made section those Factors our to our statements upon regarding Actual factors, Any the www.albireopharma.com, undertake today, website forward-looking today may at dates. proceeding, due we recent Risk include statements being would described website. filings views statements important and Reform are like company's Litigation from SEC to to expectations. These our plans subject note materially under statements section as no and Investors subsequent of XXXX, various the of in as the publicly. the results of SEC and risks obligation that on XX, management's update may various our comments These including the be as any representing these relied views of should XXXX, differ most

Cooper, Now it is and President Albireo's Ron Executive call to Chief Ron? turn to my pleasure over Officer. the

our Head With disease and estimate in us had quality Mattsson, about ours from Financial III and afternoon. Jan Commercial liver payers, the joining patients accessing regulators Thanks, Officer and Officer; Chief for We could our data commercial that studies Phase XXX,XXX of compelling Bylvay strong both like clinical me are Scientific prescribers. Hans, through excellent therapy. Stephenson, benefit Officer; Simon quarter, that execution Chief R&D. are plans. world and standard you, development thank QX, around our for cholestatic of and Pamela we this today Old And these patients provide there another the Harford, Chief highest everyone, of Dr.

resulted in of planned. for biliary III value Alagille approvals and around looking We're EU commercialization continues as the PFIC, forward expect corner approach become and Our years will of U.S. atresia. footing drivers. pace to to a and decade. to bile at Phase be steady additional Alagille AXXXX and deliver biliary acid in build exactly billion PFIC promising our the value. rollout aspiration our we the of earlier-stage financial We're enrolled a our we're create country short-term team year. drive readout The a build the plan and same modulators, syndrome strong atresia major poised a bold assets, Bylvay, a and On expect syndrome top fully corporate $X AXXXX in long-term and to of making according drug to in expertise second this and building to study half growth the plan valuable progressing are

product have XXXX, in revenues global achieving strategy of launch As Bylvay, with the net first shared million you quarter. for we global of we the $X.X in half a

new quarter-to-quarter more either that pleased Bylvay patient important capture, we total the in are a now our XXX metric sales we've the patient long-term basis, drug. drug had value While capture. relates important, patients of I'm which On process. or have to is on consistent

market global way. gain continue launch along Bylvay progress important insights and with excellent We make to the

provide them. update finding on to patients the metrics. get a a we more of the launch and larger than This bit We're on more versus babies detailed are U.S., anticipated as topics also global in mix will Pamela that longer dispersed than therapy. quarter, the in to had change expected these adult originally

metrics The in a metrics investor total feedback. that now up Bylvay the patients. add see we've and You'll format on are adjusted simplified new to based

only the SERD to study III Phase XX smallest which fall, also beyond line in and III to sites Bylvay in be for atresia on gold in report ASSERT enrollment As very progress our Middle know, in but making excellent America, is and expect a BOLD progress and Phase of China. the trial objective product. of Alagille we're Pacific. line as III and biliary syndrome data evaluating this with is trial with date prospective a Europe, by clinical that Europe, in really sites top spanning excited IBAT biliary year is in mind, We're our atresia U.S., is PFIC Phase across about and trial North America track indication, a the completed with first East is III we're on we data BOLD with With the PFIC expanding top the track readout all to Phase intervention study Latin a our XXXX. standard Asia the in pipeline end inhibitor in exciting.

is disease Hospital and strengthen have about and very Hospital; FDA diseases. President, and the Bylvay's and pleased we're system recent Pharma. all the opportunities. reason with common liver the appointments exchange CEO potential Children's Development atresia excited Board #X our and President excellent into Vice addition the pediatric And finally, Boston we're Acceleron strong of the role who Habib pediatric been company our for provides Biliary with care Dable, at former X across us indication. and transplants health this cholestatic National in Business challenges For most Alliances in insights productive, at a a Susan to of of leader with Children's Susan is Boston Alesina, Directors, the liver

have Hospital, is which our We're eventually these our Children's development sold Habib experience big at biotech both is big business to both for for Merck who leaders years billion. blend well $XX fortunate as and during experience to with pharma strategic a excellent biotech many Habib CEO as grew brings over leader addition great scale his planning, brings of Bayer. major pharma board. to Acceleron, communications Susan successful a and experience. In experience rare another

of Now let and Bylvay will turn over take Pamela, Pembina? global me the our PFIC. who it through launch progress you to of

Thanks, Ron.

the with Bylvay. of with reference our pleased on you progress Investors to QX website. XX deck you section very are team performance, the has through in the posted made To Slide the I take encourage our We corporate

let me So metrics start with updated our methodology.

added Together, X We patients pending easier of reimbursement have methodology. unique X with managed have this our the a patients, that Bylvay in match remain that Having patients these in to of Bylvay process note who the which key as to included as metric meaning a Bylvay are you our figures X rollover the in intuitive from number prescription the patients have patients account the includes PFIC managed metrics getting so Pending metric. new new access all now patients, reimbursement expanded access reimbursed patients updated total access in new pending open-label our currently in of revised patients are to net we The understand. metrics of QX in patients. more generating prescribers investors metrics who no we're our up analysts, getting discontinued. in on reimbursed reimbursed are; feedback or patients our sales calling and and are worldwide. adjusted they to in and drug. revenue, metrics total program programs It's currently on for metric, Rollover patients trial. our or patients, and on to metric drug patients net three are reimbursement, of and metrics add meaning or longer important meaning same. Reimbursed the the The programs initiated on process extension PEDFIC listened

some new year-end in of quarter-over-quarter from end That Bylvay XXXX of with Let second have me which of to added QX. detail we patients Total the at to not end we did at of end on XX XX% at increase total these, patients, patients starting the consistent patients XXX that give the at Bylvay showing QX. saw is QX XXX XXX in each double-digit March, strong quarter. the growth quarter-over-quarter with the increased is

this with experience more it because are the and gaining increase means Bylvay seeing We very physicians are firsthand clinical benefit. pleased with

likely we physician importantly, to are relief Most the reason works, have has which grow. a getting and is value patients seeing We their in of patients more in continues growth health that more and Doctors XXX that are pruritus, a you enjoying in more are number again. launch from This the hear Bylvay positive that drug. debilitating our and why this us prescribe believe what once want are to means improvements a outcomes. better and to to and seeing this long-term experience, is drug telling exactly they sleep

to Now let's turn reimbursed patients.

XX at the as continue U.K., end end a the and This and grow good path and patients the to reimbursed that is coverage see across first as pricing months in insurers the number and XXXX X of of all June. U.S., from essentially are of We public doubled reimbursement have XXXX granted to Bylvay. in coverage private pleased indicator XX U.S., In of the additional in Germany of nearly countries. a have is for will we this patients to the

at transition reimbursement of going group and pending hopefully will to reimbursement. look quarter soon revenue-generating patients as in increased number becoming of pending patients possible, The This to Now as XX. let's eventually forward. the

unmet pivotal Bylvay ensure trial of into the results in data. of of experience scientific will full Scotland. evidence clinical payers and the of month. completion becoming a with see revenue-generating. Italy, This within submitted status XX progressing III the our Gazette and result pricing which anticipate with therapeutic direct our Bylvay from the formularies days granted With the been access AIFA, national Belgium, that Scotland are among robustness well Phase publication funding with clinical reimbursement confirm anticipated the of III next pending we has value overall coverage innovation Agency, our added Together in the and need, to who to-date, of dossiers the represents market these and additional are the by in Italy, inclusion Medicines high of payers conversions We will reimbursement and XX National which Bylvay. markets European trigger team and this thesis benefit, Italian decree recognition year, patients of regional Phase Journal is dedicated that In Belgium innovation

patients. Let's now at look rollover

access on time. off reimbursed expanded is extension reminder, open-label metric trial weeks as PFIC a roll program reimbursed to anticipated of drug in and patients patients or product in XX either at are roll end revenue-generating the and trial, to X PEDFIC to extension XX over the decrease on they markets. the As This will these over the

we of from the revenue million with and U.S., sales, significant common increase of as the resulting and unique quarter, achieved the year-to-date to the pleased our on In was $XX.X is revenue prescribers $X.X the as U.S., net with QX. revenue in million team addition million Moving net are U.K. number $X.X with rare of in U.S. field Germany Bylvay in recently diseases. in connects the the patients

We to on in a revenue of are the to performance that scale. global taking seeing, our than $X.X is connect however, quickly proof with going million Germany. performance longer originally prescribing patients well This International to base. anticipated and is is get due broader reimbursed due in ability strong them

earlier, Ron and the and reality older, of the they XXx back patients revenue small in come that to to and weight proportion in early greater revenue and have anticipated age stages transition initial disease. to are stress term, are of starting larger mentioned their is difference. a of make the seeing smaller will Bylvay. small terms patients we as the transplant with Yet wide teenagers patients range larger variations from The get - terms higher in revenue want on that nature our health curve. the as weight variability discontinuations in onto we growth I improves their due heavier progressive and where liver is create bringing patients the a big adults As of A annuity of than long our can babies. of they

confident refill in well the Given are revenue both XX%, opportunity. tracking compliance rate this are above and that rates we

unique prescribers. is metric last our Finally,

U.S. the by of XX% end the We prescribers of have up June, of increased at in number to the the March. Bylvay from end XX

new had prescribers as additional the for in previously prescribers As are Bylvay. a the building to using is who The base prescription patients. approaches This confirms connect result the of an we U.S. and expertise we written not prescriber XX are but a adult and acceleration XX% and include targeting there, that community These our are well belief but as that taking -- they the are key patients we are available prescribers. longer physicians office-based are of being access to prescribers outside due finding prescribers our finding centers. to

do refer HCPs as do in In not past a to they prescribe their them Bylvay large Now progress summary, that they total making the of have patients, had need these to are we option to to therapeutic excellent transplant. centers to for patients. in terms

base to to such markets with in continue due the execute Bylvay and to strategies. III as pivotal are and we expand and We Belgium on important to the encourage prescriber ability strong experience reimbursement gaining access our Phase more market Italy data

I'll to back turn Ron. it Now

inhibitor Pamela inhibitors. that to high the Thanks, clearly our one-of-a-kind it's AXXXX. AXXXX the I in and development. first clinical models, systemically oral different on wanted And preclinical in touch AXXXX assets, early available biovailable quickly is demonstrates -- ASPD development and IBAT our world's commercially AXXXX from

anticipate liver a XXXX. We in I exposure adult In demonstrated disease the of end study tolerability. good by systemic Phase AXXXX study, II Phase in addition, the excellent starting and

share year. will for about more our later details development approach We this AXXXX

for liver for a AXXXX only be few NTCP hepatitis advancing year, D. and working Our AXXXX of component disease, the proving into end intent study combination the unique deserves a it the to a of is AXXXX B Phase world's treatment adult this asset I by inhibitor. of or second on first We're oral words. a

develop for garnered candidates partners disease, rare development both on own We both have single considering wider interest strategic have but the from to product ability and these resources of plans. assets a our

to turn me Simon. let Now it over

Thank you, Ron.

activities revenue $X.X $XXX,XXX. compensation $XX.X $X.X our million. of quarter million there was third cost principally summarize The revenue revenue $XX.X compared last The starting the is and back million. are on million. headcount international of no to expenses loss revenue quarter XXXX. the to during the for into million and was $X.X for revenue the $X.X were of to revenue second expansion financial same global $X.X force me in expenses R&D means Bylvay weight for of had was related royalty net million year, XX, was With of find sales related the was a expenses million. million Royalty for attributable of in expenses XXXX, to to million projections, we as and $X.X $XXX in cash product clinical preclinical based XXXX. syndrome I on following cost March Alagille related offset to and continue it last material as were increase $X results while $XXX.X to related revenue. million atresia completion due materials certain partially for and U.S. were as manufacturing share have U.S. increase a no Let sold the approved of clinical and as decrease of $XX.X were end and activities, a by last to program AXXXX global personnel decrease of stock-based compared per were as products was second second expenses Phase of and to share of and expensed company for XXXX quality The to to due headcount million increase of compared increase second is continue loss approval. sufficient royalty Ron Selling, of biliary $XX.X the efforts. revenue per a to progress to activities Bylvay, related study. Bylvay million activities. and to million a ongoing for including general expenses the our was $XXX,XXX, me that, Bylvay revenue passed of an product PFIC expenses, as current Cost time to XXXX product versus $X.XX approval XXXX. on partners. let continue $X.XX expense million. $XX.X in increase commercialization of Net to of an other patients we of program were well. increase expenses of adjusting Phase program product administrative costs The quarter our included was year, compared healthcare million equivalents and Bylvay increase total costs Therefore, personnel are of and or headcount company revenue our patients to variability including prior of quarter our The R&D remarks. loss support costs There loss closing current Bylvay now III $XX.X to year. quarter or trials, the to period expects well we and of XXXX patients million cash guidance The to $XX XXXX. and cash in as All turn

Thank and stronger expectations. annuity are creating and Every on more capturing trials growth. of a stronger ahead Clinical patients, you, for or Simon. week, we're more track

we'll in liver With this midterm I am a with for AXXXX as now our our base pediatric building And advance plans patients we Bylvay Operator? focused us with call and back to expand drug. the and open continue our for very Phase have on strong us exciting quarter-by-quarter make Albireo by first-in-class - a As position, and from for take cholestatic thank our and a to to joining assets company we product, Alagille growth growth. We'll biliary and to Q&A. and first-to-market everybody disease Bylvay all for drivers. III studies. PFIC the $X adult the pleased key our opportunity, billion drug a to this portfolio finally, plan accomplish -- to for leading a on patient product We near of early to focus financial to disease atresia It's we continue stay tremendous and AXXXX. liver and

Instructions]. [Operator

question from Cowen. Ritu is first The with Baral

okay hear me me? no. you you Can Can hear or

again. fuzzy bit little A you start but

now. are you we hearing think I

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time I now. apologize, a you apologize I hard having we're Ritu hearing really

queue. back in the I'll

All right.

Yang from question Jefferies. with Eun is The next

you me Can hear okay?

you We hear well. perfectly

great, a Oh so this I expected syndrome okay, question great on Alagille have fall. data

as in syndrome Alagille in dose PFIC, started whereas XXX, study, the XX. it So is

with Xx safety similar So dose same endpoint saw to and how higher the do in what we same efficacy the given compared and study you see design the PFIC?

the and think of around ASSERT those study, corner announced I pretty fall. excited we're about being this just results the

As great study. similar PEDFIC randomized to and in that, studies. very hope And study saw ASSERT efficacy ASSERT gold-standard with we first strong the the placebo-controlled and what you is show only tolerability to in really we the know,

I your the following right? dose, at get that from to results study, one study. the relates regulatory think Let's ASSERT a dialogue them. will to with another results And the it's submitting into to regards it be step As question – ASSERT time, of the that's then we'll authorities, get and you

question greater follow-up kilogram XXX XX in PFIC than as used side that potentially dose, dose? could today microgram one per is a starting it so This microgram you be you expect at do effects a

to Well, I data. use But where wait think PEDFIC see the we we'll have similar of levels we the if study XX you back and the XXX to very go we both the doses, tolerability. till saw

expectation I the be saw just have would PEDFIC that the tolerability study. study, excellent in our we So ASSERT in and we like think

the And question second sorry, helpful. is that's Okay interruption. sorry for

Go ahead, go ahead.

XX% Yes U.S. prescribing -- patients centers. in more are so in is remarks, in outside a and the base prepared -- prescribers the expected than you PFIC, mentioned that the key like you dispersed

sales you you that with and your think will expand So to do syndrome be with there reps? you think the that, Alagille would do similar need patients

of saying out start getting to more we're pleased with prescribers. by that in doing to with really unique we're XX% So I'll increase prescribers terms XX just how

that community be we out there continue anticipate be And we'll prescribers out similar PFIC. there we're centers base those And on. For unique may with expanding type news the with we're finding finding key like the prescriber that good is base. call will in those to -- patients our and Alagille, prescriber of a

but our really expand we're that. will confident really, that not reps, So and field X we team maybe need X beyond to more or nothing

PFIC, pediatric our hepatologist thing Alagille exact It's great the that Eun. and prescribed That's for for about the biliary same atresia. model

to be appropriately able opportunities. So those advantage we that think to we're sized take of

Okay question. my last

that Does and that higher mentioned discontinuation than it's Pam is So greater a of Do refill XX%. order less discontinuation the you mentioned rate you rate patients. is imply XX%? and local body than kind the somewhere the think compliance rate, around weight

take just to step So back let clarify. me a

refills patients are and in speaking get So different month, therapy X who take at the that So pills, these on on no, was of the end to month, are do persistency rate did right? really all so they I the a compliance to has of time. their rates, they given the their all

that that's so we're high. with quite -- pleased And really being

The But That would expectations, -- around is a X metric. we that are a want different question those disease. was what think different a asking clarify second that with do That's in discontinuations. were seeing -- rare the metric are that we for you right different is metrics. line question just to I

you're disclosing rate? the So not discontinuation

one of we metrics from reasons previous Well, that's you our changed slightly quarters. the see

of have they a the That's called You the for would have relevant revenue. see and at therapy. And metric inclusive that new withdrawn reimbursed in drug we patients who this you. be metric time, more -- probably from that's And that on connect are directly patients, right? individuals that to

next from Tim with The is William Blair. Lugo question

how originally so Tim. that planned? were at how many you much each be like? expect if than or international much is second, you pricing -- force prescriber targeting? markets talk on I base. about have on is Can now just in Lachlan do the more just you don't to you And might think saying but here do the know the of then any This expand color you physicians the then mentioned those sales A couple you broader and how maybe wins, all, for investment you looks

that -- we And second that's for the to question U.S., sure in sure want are what we was I first broader that think, markets. they correct, the prescriber were? you're your that I much terms And a to price. just choppy us. how about of what is? have So I in there your was international what anticipate that around on right? just I want of number around the make you Lachlan, the that I -- think believe we little question, questions make patients were the asking base

Correct.

So of grab Pamela, hold why that? don't you

the on prescriber the we've still so Yes hundred seeing that is focused base, in the mean, talked on what quite centers. about the I question XX physicians first we're that broader we're key on always

terms and there's patients is the there that potentially centers most that that, look physicians in doing beyond we're the of potential depth and physicians are those likely What analytics is And to which that prescribers. are of better there. through to able we to understanding X,XXX then prescribe. So advanced around we're with other as really have a of

going disclose in again, your say, it's just country there's can to as look because rare terms there with this not had Italy really population Belgium And I really well. your what population centers line in each the even patients countries, I estimates expected, as for bringing of time. that's markets. industry faster models the expected pricing and something been disease of have deep pricing, The would on benchmarks. with well. reimbursement, those see we've question pleased than then think in mentioned, and the we're negotiations is gone the able is second terms right to we've On seen We're that the base. pricing -- of number and of broader But a in the I So, Scotland, the on something from overall. countries at I outside of you U.S And in of in European that sort going then guide that think, broad we as your prescriber

X..? the seeing broader A or quick you in are subscribers seeing you seeing depth follow-up or the you here, them -- Is they key as are like it centers. mentioned much are you X debt

patients broader prescriber the No, X base. you're absolutely right. X in or

again once So start, remember, we right? right? will new --- would that anticipate identify they pretty that new be launch excited, expect. the process, that we as gets they us But still as patients in early patients of they Because depth prescribing. But we're that's what

with Brian is The next Baird. question Skorney from

in about the can uptake you hoping briefly was the I talk EU.

of Italy sounds it in contribute Now start U.K., reimbursement doesn't but like Belgium, and October. Belgium until to

how have how get versus drawdown, back Italy to on may since Germany? where quarter little seen and factor over in last sales last today's out it the some much fourth of sort mean Germany U.S. then inventory you dynamics last an for I like U.K. reimbursements? of there and in and were $X all of followed wanted Just these contributing U.S. an a by quarter, this talk terms stocking about X growth quarter idea U.S., the specific of effectively and was reasonable flat reimbursed inventory quarters. much front. expectations just seems Can that of kind in a quarter seems It the if destocking bit million. I be to pending you patients And

Brian, this Simon. is

QX, EU, we this primarily have that countries from way to already continue the it expect in really of terms of of sort the remainder year patients In is that to revenue the need you would the sort to be of think about going launched. forward for

U.S., in So May. Germany sort late of U.K. as you and U.K launched know, the the the

where flowing see As you patients the we fast should forward then into QX, is through. Italian start and Belgium expect that to

in was to saying completed example. think, rollout region-by-region. Italy, negotiations, As we but for wait the and I still have regional then We've Pamela for publication

So that this strongly happening will of quarter the start in fourth year.

you As steady a were X-quarter we really topic at of back think your inventory on QX. end U.S., said, that about the the we sort to And inventory as state in the phenomenon. of question was of

reimbursed and generating why end that the to were numbers on yes, the to growth patients. is drug of your we've actually on due given these it And meaningful quarter, variability fair specifically minds grow. patients. and So QX U.S., is flat to hence, weight say continues who our that in to to metric and QX between at in are But here it really revenue the you between revenue question the the more

is from Wainwright. Ed next H.C. The question with Arce

fact appreciate to XX%. now if then do for stand and of case, to the the early that the me, patients have the And could per range you Firstly rollover stand us on in terms both average U.S., I patients. mentioned, you I first that at the time I right wanted understand gross detail as the that you've I in for And a and revenue-generating follow-up? think patients. us pending and the as why is have the help in you the extra - for at conversion could confirm -- now you a pricing net provide to think

off, first so -- just asking Ed about patients. revenue the So you're

talk drive take so the about So Pamela Pamela. is that the about Simon in U.S. time and patients average it then XX revenue. question can will the pricing the

conversion pending time question average reimbursement to X and the your on rollover your correct? was question, patients, on the that So categories,

Correct.

Yes based countries. differ different going that's -- on so the to

depending those for are X those number reimbursement So have the don't of which yet submitted. XX we've markets patients, in categories example, dossiers of countries Italy any have that in of in -- the we in a

of mentioned, rolling and So some number those the from Belgium as we'll patients XXXX. online over into come as have countries they just then QX. at a will good has And other patients the Italy, then from other Simon have countries --

process patients the going early rolling pleased really we're going that know, with And the next drug. that number year. through very in U.S., authorization we're then quickly into get you to as to to there in over is have QX fill reimbursement able our through onto -- prior U.S. that patients we're are patients and to excited that time in So of well and as

net, the in patients question patients. currently, to close U.S. I think about are XX% Medicaid to yes, And in gross terms of the of

and the those Medicaid very, remainder the are obviously, Medicaid. obviously at are payer they're very patients discounts different, from of So standard discount, commercial

gross mix So to net. as X of to it things those the sort drive relates

growing year XXX Okay total question, those quarter, XXX of the and if next in I one all through growth first fourth -- are XXX to at the right. the way remainder -- from the this that and patients into just growth look past quarter and trajectory this XX.X% of in reasonable year? about And a think the then then additional rates is

excited quarter-on-quarter, first same I about I Well of think, roughly right, patients, it's really new the is is all, of Ed right, and XX% capture the think, what XX%. we're

patients there. are that's consistent -- So means very out that

can these so fact over dynamics. quarter-to-quarter in very There's lot do will time. have because, difficult to But become fact, had we've say projecting us. revenue-generating of reimbursements a that we is are pleasing think consistent And patients I all to us that new I are been that coming is to the that in.

with question Wedbush is Securities. Andreas from next Argyrides The

here. been Just number call you the then And a I details seeing XXX if of here, provide the don't the QX. of metrics. end of patients I across you're the just new growth versus couple caught but on clarity rollover Can all a know provided bit choppy, X at has XX the

reduced the one I sales then driving ASSERT? And So on have guidance? follow-up what's

little don't with why guidance, we reverse a Pamela? you this do don't metrics, and bit about in talk Why help you Andreas maybe So order. Simon, the then just could the sales

Yes.

as you the infants. we've news which to what's this Yes continue seeing to and expect patients Andreas, the on, disease X driving babies patient have the about is heavier good sort advanced is transplant, we those that had of have obviously, of of progressive them less groups. as several factor them would And originally then grow between equation, is just as $XX particularly the anticipated. of guidance more to the they is terms get, prescriber really here. of U.S. for with, than they variability million patient time probably secondly, given the PFIC. the in benefit in in sort we here we is or And generate quite though terms other connect been transitioning that's some referenced to with the XXXX revenue then the whereas to catch patients patients liver to of sales what who patient disease items starts The sort broader begin that now quickly One were times early we're had in more base

that's So biggest the driver.

and If we of of $XX.X we've first the year, million from half markets to and the again, bit imply continued maybe you a launched first both or would in where little expect would step-up half, think already I in Belgium And revenue. in $XX to half, then quarters for QX million half. million see had about growth patients. $XX.X second the Italy of This second a

QX QX question, patients rollover what Andreas, category of reported so we potential other and the on in difference category patients. first roll your the between the of And

that definition mind we the is first category. keep to changed in updated The thing and that of

-- patients driving those removed on category. into we the put are pending the We program managed So took reimbursement difference. that that's our and partially access what's the

well the partially the So why PEDFIC seeing patients. as in now, rolling that been then open-label as number you're that's over because within patients there. category And difference that, EAP in X the extension the right, addition to patients is we've

we there. them patients. patients as the the rolled explain numbers And over we so online came as Germany in dynamics well different just couple that in hit mark, XX-week the rolled as of we over U.K., with a would difference And

whatever then number the Okay. that prescriber the that target U.S. of per estimate? number what's you of is, so, Have And average prescribers? if patients you provided

potential you at on, XXX ones tell are broader can patients seeing in They're remains XX we focused are that out the about some key same. have that is into on. much and been community hepatologist. with I as the provided because What X,XXX there's, within the that, number more out beyond well we're actively We've community a what looking are centers adult of gastro is top prescriber the are there prescribers then the the is -- as more focused prescribers that we we've of the who And patients what targeting. urologists currently shared, very base

we'd obviously, early all So of early Andrew, depth, able we're it's going say. we'd too and prescribing to launch, well. to has to in up that be there's time, of in greater of to anticipate sorry I still more us, So like as to to that think, But us right? right? – gone the people pretty to excited as It's number And see much terms with depth the prescribed for be XX, over depth there's right? these,

last you caught readout year-end you has is the discussed this if caught that contributing ASSERT the don't the know the correctly, to timeline what timeline? I on timeline, factor I this for and the moved fall. from for one Okay the ASSERT if what's this, but

study just first the III to some pretty in syndrome, the certain be We refine Alagille Phase guidance is and to fully more our that see excited little so, enrolled, study And right? standard gold accurate, around the bit we corner. good a wanted hope data to we're

Cowen. Baral is The next for Ritu Ritu. question from Yan This with is on

then be line persevere. -- to characterize sorry, going question it choppier, My is but you're Do the more comparing it is the a of around to towards issue. saw as is of that I'm progressing question The surgery leading that Phase what you would discontinuations the tolerability still And a you seeing. more little of the patients study? sort sort or bit III in

take question. Sure, that let me

And other are saying what with start discontinuations line the in we've expect just I'll with efficacy. what disease. right are to seeing really not we pleased that and that First, would we rare in seen discontinuations we're due

with the of question, was So last patients fact this physician were sort for advanced of as that a to ready were at already discontinue they liver quarter, that as liver resort help one getting we've we least, -- seen prescribing to the in to on they were your They disease. some reasons path is The the transplant. had patient see transplant. they

sort that not went been Bylvay. concerning disease discontinuation reasons had But with the just and transplant have sort you and that with then the I patients the any what again, would of of stop just family So expectations. right would of in is category see dynamics often line And discontinuations. more some that this as to to in on say is we other see those social -

Okay.

a So with to I'm of follow-up questions. couple going

How of those higher characterize patients expect you understanding that about of you to that that now? as to do into How of X patients you Have would rates? sort help quarter include your the more into numbers? quantify And perhaps steadying what that age your also, of describing you you expect patients So or start sort average discontinuation give category then the, targeting ties patients. numbers my you having how expect sort do changed? idea of of And out? of were the an last same of your to probably to can shake or feed size have

Sure.

of seeing new a bit little Let are seeing excited the lot babies be what we -- is that long-term. we're starting really is a me because to going that are about with us therapy, younger we're talk and for they they're because about what something

a patient And in so that starts. trend that terms of seeing we're is

It's variability. still the overall, would launch. what seeing the I I age, lot early. say We're think in it's a early of

of And pricing lighter our lot in that patients, We are seeing cause short-term. variability. I patients. younger patients, the with dynamic, think And does that's older a patients, heavier

patient numbers Over we the really the will things long-term, out. smooth excited think we're as grow

more to get that relatively beginning you the you start sort add you're small dosing with just as with if weight-based teenager, there significantly think would I at a about when and of you Yes a were number revenue, patients, Yan, than obviously of if over the of a with lighter a the continuous you to or younger though, be infant. the in over Ironically that the disease, starting patients ones the the that will create the annuity capture of early sort ones baby progression and long-term, long-term. those want

model. something as that's you So think to about

end Cooper, reached to turn will the closing I Q&A of call the Ron for portion. the We have now remarks.

provide and execute you each every and patients Thanks Keep commitment, ability thank you, very continue of deliver the am today's liver employees as you thank attending much. and our conference thank innovation. disease well, for and with proud very we to operator, this to all their of advance Right plan our for community. call. liver updated one I Albireo's families to hope with entire to drive mission in organization's

concludes This today's conference call.

you a your have participating, disconnect may lines. You Thank day. and for pleasant