ALBO - Earnings call transcript Q4 2021

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Operator

Good morning, and welcome to the Albireo Pharma, Inc. Fourth Quarter and Year-End 2021 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] Please note that this conference is being recorded. the of to LifeSci turn Arndt, host, now Director Managing Advisors. will call your over Paul I Thank you.

You may begin.

Paul Arndt

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

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

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

Ron Cooper

Stephenson, Chief of Officer Chief today are Jan Dr. us joining everyone, Commercial Financial me Officer; and R&D. Scientific Simon Officer; With Paul, and Chief you, Thank you, Head morning. for thank Harford, and our our Pamela Mattsson, this

summer, burden families journey of historic the first-in-class high Albireo. realized was and books medicine to our year this So with in that an one XXXX, children from we really was for company one record Bylvay potential back with approval of across Albireo on different It clinical-stage a drivers is where both managing company amount three product bring for the approved the company a to tremendous company. biopharmaceutical a our transformed was a and and is integrated of a approval rare Last with it the growth Europe. of to value. disease reflect building step U.S. an new

Bylvay First, in PFIC. the launch global

Phase would provide for Second, second use the Bylvay disease of Bylvay our X treatment and expanded of a biliary XXX,XXX approximately emerging to in liver studies early-stage product option the the syndrome cholestatic patients half in billion adding make $X third, And the the BOLD allow our us atresia rapidly decade. new Alagille towards This indications. of ambition additional products. the worldwide and with goal with ASSERT two a to

begin by Bylvay Starting let a Today, in the on going So speaking about fast one direction. PFIC with me launch. update. only we are delivering

at HCPs making this to terrific. but ended Bylvay was updated you revenue. the As our start so and an response of million we're the to more morning, tell for to the is end and high will of hearing drivers reported takeaway launch XXXX this impact, fast We're a from is product we're prescribers the $X $X bit Pamela seeing press from $X Bylvay on that a about in of the deliver range. year million patients million. the the $X we performance, XXXX Original million, update. thrilled million $X in delivering to is release guidance key both We

additional new dosing. recently gain we that in for chronic most increase progresses, the And as in growth they is achieved, continue the patient patients medication. base, some planning UK. their in discontinuations the to and as on two therapy weight-based continue like prescriptions from to growth expect Bylvay for reimbursement as those will Playing then with daily initiate launches year to each to that see a We patients we're initial opportunities and as these is will Germany. And grow, will country U.S. beyond Europe quarter pricing continue

you overall, potential more Bylvay cared continues I'll achievements. opportunity detail turn diseases. metrics to Pamela? launch, children families the with in through So cholestatic who get for our it great to grow and to with over on into liver Pamela impact the with for are take key To

Pamela Stephenson

the the providers the Ron. feedback is really In a we relieved consistent PFIC outstanding. treatment. recognizing launch on that available Thanks, patients Bylvay. strategy option our outlined are on a payers our plan global they and we drug from who by X,XXX payers ongoing the the Bylvay that patients on for five have and the their impact has we I'm with Today, fast it. been are planned, patients for physicians of need are with to going uptake QX, launch as key report value basis. unmet and reach to care metrics progress covering delivering pleased The are and estimated response health supporting is have and made The we a to from with

product to revenue our and $X the our European Overall, million sales and million launches. net bit $X.X the total represents QX color international. $X.X million U.S. with total U.S. a international So Starting significant go to revenue, these let date the and the XXX,XXX in the net beginning We the leading with solid U.S. reported be Germany through little in penetration in for in provide five metrics $XXX,XXX performance me product year finished out total we with and in $X.X internationally. in market of with million of at a you.

new number is in of generated metric new prescriptions second These are Our prescriptions. total XXXX.

are may through going recall, As reimbursement process. the you prescriptions still these some with new

the totaled the generated interest XXXX. this totally number in new we had prescriptions saw market. of in the new we period XX in of to As clearly and worldwide the XX in the then prescriptions – we by continue early prescriptions reported, patient with This QX, need we XX launch to reflects prescriptions grow QX, unmet end the

and they potential the patient's first quick brings when contributed our services a in-house getting experiences specialty and that have family The decision XX an working that success of interfacing model a clear our and arrive and their Bylvay. planned access to a the Bylvay. number We gaining indicator Moving payers Bylvay team total approved companies in has rollover reimbursement of based had AlbireoAssist third and another are the driving on at on the prescriptions quarter, were end each as patient approved and on of is the meaning of support patients to the Physicians added see on patients evaluate the significant recognize insurance in this shipped. to Bylvay. gain by these a been to Through with advantages patients team program navigate have in to XX all patients is insurance with is payers we three benefit year, to that very and drug. next to Bylvay. XXXX. reimbursed value are strong seeing shipped patient This The understand product AlbireoAssist new we advantage for supporting our prescriptions XX of number access process, to on of is pharmacies patients patients which have already reimbursement pleased our and value metric product

launch prescribers. over and of patients Germany. expect U.S. last XX captures study, refresher, to patients the PEDFIC than metric transition With the and we quarter quarter, In the time, the a markets, had program. is demonstrating access in the on to we reimbursement Patients this that prescribers with managed reimbursed The our XXX prescribers, transition As commercial in XX who patients. unique in quickly QX, of continue or U.S. ability and to and many commercial third XX the doubled drug In unique pricing EAP around commercial Bylvay more currently rollover patients, we transition in end reported sales. at And our this the the we as we extension included of X these our our Europe year, available to to in year to roll we currently reported number and to fourth are in in are sales patients to patients future. these more number the end gain

great experience with immediate have who are breadth We Bylvay. progress, of base showing and now making physicians building a solid

are penetrating with multiple happy We successfully new by reach our continued prescriptions engagement generating market and I'm and remaining the by targets. really date with the to prescribers,

U.S., about as momentum, launch in awareness that the In and our While obtain prescribed assets and reaching around U.S., the and option are execution in we treatment first XXXX. excited other launch sales world. Bylvay and with the Bylvay, while the performance the for is ability prospects successful Bylvay with confident we to of deepen the Priorities of to more drive reach reimbursement yet our physicians increased gain patients. pricing are we U.S. to the penetration prescriptions feel centers the ensure and the in key to as the in not of also and for pleased to the We countries continuing PFIC. even patients have grow are families

through – those we patient new as patient new country and we less the continue together sales XXXX in launches, and continue added a Then as year increases to sales base launch for that less as to from add successful up expect our We sets work grow. ahead. increase to will well patients, our discontinuations our patients which expected inventory us value

now the gold SMR data other countries a health period. has ASMR encouraging the received France, we confident and have and exceptional Bylvay. standard impact perspective. which a Bylvay that an the As years. team, Health package the our Bylvay that the NICE, will Very expertise clinical believe recognized been for Europe positive HAS and In ongoing pathway. both are as across value and and many issued program of from we This guidance economic we have was to and technology is is that important ultimately, a clinical and and Transparency through In the independent Institute who preparing assessment need, Committee, this the by organizations are work have have result HST and Bylvay assessed execution actively III from look and This with the fastest Excellence, pricing access pursuing compelling HST that to we that reimbursement reimbursement as that achieving in a evaluation high we've of recommended we price announced countries. data medical for Bylvay done National goal our XX discussions unmet the recommendation and pricing create that a came the ensure of we ever, Care the in pricing reimbursement high to at country that for reimbursement, multiple And the first Bylvay. are assessment have for reflects at in recently, Europe, global has patients while that is or degree

While Italy, net approval ability what such pricing countries will major we France price in do gain reimbursement not the our and know be. remain we gain confident to as final when reimbursement and we and will in for

continue countries, XX Europe. rollover patients intent in an progresses, the majority our important of of with will XXXX year this additional the residing is for in As be and to to growth approximate European launch driver the

prescriptions Given market key countries education, PFIC reimbursement, our outreach the to footprint. and expanding gaining very global estimated new start, are in access solid penetrate focused through opportunity on moving patient X,XXX actions HCP its geographic our and to

let over me turn that, to it with So Ron.

Ron Cooper

launch. entire and excellent Albireo Thanks, and significant it's Super. Bylvay difference. team clear Overall, making for there's a congratulations and our is an Pamela need a you unmet to

liver advance drug As to product, billion-dollar drug. a a the disease to a us for from plans PFIC Bylvay our leading to take Bylvay cholestatic pediatric make we key

pediatric on study cholestatic that? Bylvay X BOLD drug. track global phase tract for two-year Therefore, in X the a sufficient study pipeline group the is standard, randomized, in atresia a to positive executing is outcome. and to high that as deliver the liver be billion Phase BOLD. we’ll the need. and number on an deliver end our with are or liver X your gold frame. first would sales. year line the – of we time to quarter-by-quarter. study this our confident about FDA called first a There remaining a data by to randomized we Phase with option largest PFIC randomized, to we placebo treatment study the XXX other given do X,XXX have commercialize Expansion and world that programs, is is XXX,XXX the in is first standard building on atresia of the agreed great level net second studied deliver an disease, an in First, the only patients patient approval to achieve the with IBAT, the unknowns patients the pricing this over we’re PFIC both to a study, diseases of syndrome EMA Also how PFIC, ASSERT continue beyond born with patients acquisition looking have are and another yet. gold not been Phase up placebo-controlled in atresia So Depending a placebo-controlled assumptions, X Phase looking on penetrate be continue top to ability our base goal double-blind, trial at to We that babies and in pediatric patients X,XXX $X biliary that be forward this pivotal readout our for to important ASSERT into double-blind, Alagille gold of translatability we’re of in trial the potential know of have able drug is year. to cholestatic biliary to standard biliary who matched as

So to for complete our in of XX% than the to execute patients this XXXX data year, guidance of enroll expect effect to we’re end be readout the enrollment proud and of reiterating more and XXXX. ability in by our top line really

for of early are emerging assets. value driver our Third rapidly organizations

products high with and systemic and is clinical one-of-a-kind unique the in development. ASBT only inhibitor two world’s have AXXXX. bioavailable We AXXXX AXXXX first

can the from intestines remove does inhibitors, only in end anticipate X the in the other In preclinical urine mean? humans we through tolerability. which Phase year. the like disease, our in systemic to but what systemic were bile our we we of next the by exposure Phase replicate excellent demonstrate this to and a by The good IBAT demonstrate that question key with we stools models, So the effects plan it and X kidney. is not starting study, study, body, In acids AXXXX this to able

which We in available oral currently the inject to peptide AXXXX, have inhibitors the and also and EU, effective only but have first Today subcutaneous inhibitor. a world’s an drug, is NTCP it’s you subcu potency the day. are the is the look completely yourself for like tracking AXXXX, NTCP every If markers the target and and engagement similar. single we effect development NTCP inhibitor or at on NTCP that

with one year as us and a a systemic by be oral advance this demonstrate has hepatitis X the an who AXXXX is preclinical Constantine exposure maximize is joined careers of the and Officer clinical driver a pleasure allowing diseases Second, additional with great integrated Bylvay call and first-to-market have intent products disease. Drive with of a with Albireo and our appointment major assets, plan, profile organization, drivers: our companies in have Bylvay models. near-term the to to leadership pipeline for role was three and exciting Phase to with X and the December. the our organization in tolerability launching commercial with growth and into leaders way into evaluating update. we’re the the expansion Prior we now Phase early with in with our However, our future. growing two other plans as our in of our tremendous combination be leveraging XX our my turn a licensing that, Pharmaceuticals, cholestatic and in AXXXX the assets of inhibitor, Simon to completed with Constantine the Simon? over plan part opportunities candidates transactions we strength the for and be strong small adult Genzyme. our organization Business liver in will third for enterprise proving of a with is, their us a being study component of capabilities first-in-class order for the growth spent partnership company. biopharmaceutical end difference recent programs; as It’s Overall, that to is in liver Constantine it’s to to of unique for Sanofi also to potential an the in key product molecule have of as treatment and accelerate joining of the for similar subcu over biopharmaceutical creation to experience PFIC; Boston after where excellent dosing opportunity our with before B&D. we to and he Chief Chinoporos company financial team NTCP Need new First, a of safety expansion With the

Simon Harford

thanks, Many Ron.

fee the the top U.S. product which $X of million revenue to and due XX, year health recently $X.X the due QX $X.X international with year. is revenue elobixibat million, year the year for revenue $X.X specialty guidance to revenue U.S. and quarter. Let announced $X.X compared the for XXXX, XX, year international partners. same Bylvay was and rights was $XX.X treatment the at full the product from for December of to ended stocking passed with December Jadeite, full $X.X milestone the for increase of the from upfront three Pharma $X royalty compared was fourth XXXX, estimated received ended $X.X full the quarter was increase of XXXX million to of be constipation, Fourth an million for licensing both to revenue revenue and quarter Royalty for $X.X me XX, XXXX. the the results $X.X $X.X was and the EA of the $XX.X higher was of Bylvay received was XXXX. sales Bylvay deal The revenue range License inventory was year million There to year license related care to financial with summarize product million for for some for for ended year revenue million, million. million million. to cash XXXX patient quarter million of and royalty an $X.X our of QX million in million Japan. XXXX relates fourth $X with period for revenue U.S. our million the $X.X full achievement no revenue our to million in end of revenue full on million was in Bylvay Royalty of $XX Cost chronic increase million for an pharmacies. XXXX, December and million. for at the revenue $XX.X

approval, costs headcount and Bylvay product Following of were revenue. certain products costs quality manufacturing There expensed were to no cost materials as current now prior to approval. are in sold related included material

ended QX increase biliary Given XX, of previous increase well for pivotal with revenue quarter million. increase in ended year cost for Bylvay R&D year, we to $X.X December XXXX million. both SG&A XXXX, quarter increases for expenses expenses for of as in put $XX.X the an due The offset $XX.X U.S. in in we the The summer $X.XX or fourth an million R&D million $XX.X marketing for full X a year, and $X.X $XXX.X for as well studies $XX.X in the the our of compared XXXX XX, million the $XX.X primarily XXXX as The $X.X up in loss the fourth long year. compared term million XXXX loss the and to full necessary a increase $XX.X product Net million. study period. XXXX, the made compared and million with operations. XXXX, stage were governance loss $X.XX an NASH. no compared SG&A million related completion a million. year approved million ensure December of share the only of sales quarter QX was the share activities ended people European was were of appropriate Bylvay study an with expenses elobixibat the million $XX.X in of were place of million commercial systems in and expenses period $XX.X to $X.XX per the of loss of commercial by X also attributable the the of share a appropriate R&D compared $XX for primarily to global for were of or million atresia was and Net evolve million of basis. period December same related for $XX.X a were mainly expenses as AXXXX, for XXXX fourth year efficient XXXX, operations the there XX, previous per year for of was expenses PEDFIC or headcount $XX.X increase to the million were need a preclinical to of and on the a as prior support compared X of due the Phase share increase year to increases XXXX, with XXXX, loss was Alagille the SG&A and in ramp-up syndrome in per for biotech commercialization Bylvay. previous to and as functions $X.XX Phase to or expenses XXXX were per for commercial $XX to loss XXXX.

the of and of XX, cash million. XXXX, at December least $XXX.X cash As equivalents had company

million versus the of $XXX.X end September exactly of have did we $XXX.X as million fact, In XXXX.

current upon current We and revenue XXXX our sufficient expense that last cash is are reiterating into based to our projections. guidance

time For product Bylvay year, once during be we Bylvay the to better timing in on to we XXXX, quarter $X first provide million European of the full revenue revenue appropriate At anticipate launches of year visibility look we million. have markets. between the and the will $X guidance

higher in to of gain international second we with continue sales. of revenue we in However, over and as patients a half the hockey for revenue markets roll the when number year and reimbursement you XXXX, about the launch think to outlook Bylvay expect commercial in stick a

free specialty will with persistency weight price be pharmacies net more likely based three inventory the of European in lower gain, current XXXX QX per but to patient end a on total is the launches the rate. could Germany, Price Some reduce beyond we U.S. change potentially expect and high pricing in in at U.S. XXXX

will there However, inevitably discontinuations. be some

launch will are for Ron metrics continue remarks. anticipating that, closing call me let back and turn monitor to With early to strong very a the the over year. We

Ron Cooper

Thank you, Simon.

XXXX. over to plan it the turn commitments and me our what additional and growth on announce I to add Q&A, track We ASSERT for deliver time quarter-over-quarter development and summarize expect We fulfill with X in lines. let Before remain enrollment BOLD as we plan on Phase of full countries. launch the both we Bylvay patients to studies as we our

important of the expect year. an We X ASSERT readout Phase by of end the

every each of and Q&A. commitment, for drive the joining We advance for the Operator? innovation. I’m for expect and us now planned as time for thank thank Phase to employees also call one open proud a to into proof-of-concept We humans the the and are of our AXXXX and AXXXX everybody ability pleased of execute their organization’s and our very first deliver into by and end X to study year.

Operator

the comes proceed question first Eun Yang question. with line Our of Instructions] [Operator Please from your Jefferies. with

Eun Yang

level you. Thank was you at last inventory the year? what of comment Can end the on

Simon Harford

in specialty Eun. international the have the to for first and out in year, three launch uptake, no as most markets. revenue any at Hi, I That inventory is relevance wash Simon. This for part when this quarter inventory those ship did the of likely we pharmacies. there pharmacies of is during to was we’ve the inventory some actually recognize mentioned the QX as We U.S.

going is do asking to you what you’re I a how So forward. think model use baseline

drug further good inventory using So of XX which XXXX quarter. But reimbursed the will by prices terms probably up who to down fluctuate the of on is trying a average projections. in net revenue, are are baseline of patients at project XXXX, and to who growth withstand end

not situation. that’s So we’re going quarter-by-quarter, the into to detail every get but

Eun Yang

million, number? in XXXX. increase Okay. half are as launch said, year you you do that $XX going for the mentioned to second the general on. sales then is about Can consensus feel rapidly current how the this you in about But reimbursement comment of countries and sales consensus you coming Bylvay that on And

Simon Harford

be Honestly, at given think said, with to this premature, clearly making is recommendation the would international good that stage, uncertainty reimbursement. of our really we’ve and well in markets timing provide the of guidance progress nice mean pricing that due innovative we area. around information in both the I it pricing as revenue strong news of good we’re reimbursement. to launches capabilities and product, the as a burden was our I care the nature the And really management endorsement think as of

the anticipate come. year when the have when we question of the year, why So to about when more a just guidance give visibility. we would on is things more end, in But full and saying happens feel that. timing swing timing and point the on can for clearly, see we’re being depending it likely that’s good you we’ll The further that at back to are given nature of those launches

Ron Cooper

year one visibility potential we has those patients metrics that indicated as patients. will other on the about And this, there’s well, rollover nice have that Simon revenue. going those and right? pricing impact swings will that are report that individuals. commercial, those in are launches the into our significant the And markets, XX like a is And Eun, roll I But a we international there’s those when those and occur, better and reimbursement, right, of in pretty perspective. think The of factor have of get and are on so discussions indicated we’ll the very about on, goes also to that think two has from other Simon as majority

Eun Yang

one My last Okay. question.

So patients who got you. on Bylvay commercially, Thank how have many of discontinued? those

Pamela Stephenson

bit that’s yes. very have considering in handful are pattern is discontinued expectations. measure. And This some a in Yes. emerged. that There’s no discontinuations, real line Hi. much the patients a of We’ve restarting. of of seen dynamic It’s fact, with a

Eun Yang

you. Thank

Operator

Thank you.

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

Ritu Baral

are NRxs we shipped? Hi, Thanks fill we’re Have have to as at in And also, for trends, guys. started the children, but young expected seeing out, in a the trends, difference you on in seeing in NRxs started trends Thanks. months et you unexpected call quarter things between our versus those and look some not XQ, cetera? question. like adults just you first you community-based prescriptions, any seeing of time mentioned taking NRxs new XXXX, trends now previous that handful

Pamela Stephenson

on your answer average time the question me fill. to Let first

great patients reimburse having Bylvay. through the are to success system getting and in We on

through, cases. see The we’re able take We prescriptions Bylvay. able quickly, some continue right? of few and that a as really and And weeks wide patients to the some to prior we XX through it’s expected, exactly go get very been and range cases through the authorization a pull to reimburse coming on process, we’ve pleased to to in others appeals we’re

Ron Cooper

And sort patients think first deeply and U.S. more what of you’re that second who really penetrate are the asking, is the suggests number part so of And right? the that you of than double I delighted then see in what the trend just of we’re is almost of right? think And prescribers, the I we’re prescribers, all, to starting Ritu, to

well. patients like wide play base the the really seeing that, the trend been characterize centers, early getting and patients tertiary North we’re then of have range good been from as terrific. to penetration patients We’re response prescription centers But range and pretty right? good really majority expected, that are in really And as a we are acute weights but physician of folks has some or much the we’re Carolina, some where of sets get and we’re that that patients initiated are Kansas the majority in with gone the and as to where uptake of same are patients The fact, those ages well. at that a where really secondary pleased the in seeing patients we places seeing we’d

Ritu Baral

Thanks. it. Got

Ron Cooper

you, Thank Ritu.

Operator

you. Thank

line Baird. Our your Brian of the from next proceed question. question comes with with Skorney Please

Brian Skorney

and Good quarter four-week that. build assumptions XQ U.S. the that normalizing morning, you but taking I get seems for of inventory everyone. to a should the in bit Thank hoping that NRxs $X.X question. kind just just and if maybe for XQ, – of a like mean hear the on of may inventory guys granularity pull some underpinning be a offset. even to XXXX three-week, you in headwind I like assume was kind million guide get my last I build the of kind of are I

understand, for quarter? flat guiding are So trying headwinds to to that of other would I’m down you inventory there sort just a be beyond

Simon Harford

Hi, Brian. This Simon. is

in think forward, you we sort And I that does what fair you some that the think those on drug going of think patients some sort here to year-end. average and QX anything is as say nothing I as about beyond baseline initiated think fluctuations about need highly price have would relevant fluctuations because sort But $X have XX a not of at to inventory at of as it’s to more beyond really million $X say normal think inventory to I is about then QX really year off of an I to the about patients million. net there’s the that. say growth really

Brian Skorney

dynamic between be we ALGS add that weight should the thinking How PFIC than substantially for pricing in thinking And PFIC? testing then in opportunity. dose, that about differences could and patients? we eventual would Thanks. about I on there’s to seem price ALGS that XXX Okay. ASSERT a the per be just it maybe is given should ALGS as microgram if be higher question potential one like And just in day how average

Simon Harford

of your questions, for both Thanks Brian. Yes.

look right Alagille of baseline if it’s the you at think the now, the weight I to similar PFIC patients. pretty patients,

get microgram let’s We that. dose we And are wait the I till using the XXX think see in results. and

pricing market see looks questions, time. kind that of Brian. and the your dosing wait like at out what for and will that sort Thanks a Let’s perspective from at

Brian Skorney

Okay. Thank you.

Operator

you. Thank

Blair. Our of William with question. with proceed your the next Please line comes question Lugo Tim from

Tim Lugo

question. taking Thanks the for

European, $X transplant through, the how can expectation, to you Going that I does as And back million change BOLD maybe that? serum $X undergoing levels? liver does that any endpoint primary maybe on and just the assume came over on guess, million next QX proportion versus the materially the decide positions month? comment bilirubin using does come your of I pipeline, you study And if one to patients reimbursement guess the to

Simon Harford

the Hi, take I’ll So first question. Tim.

Q, of UK, – be because, the will that which with and assume the NICE, actually on recent In launches we the market. Germany takes does recommendation get QX, up terms in additional roughly the the days would in obviously, before not from XX one next any beyond fact, it to

So included. there any isn’t Ron?

Ron Cooper

Yes.

a BOLD. BOLD, So made in that with progress to we’re regards we look, excited pretty lot of

end XX% We’re the by enrolled now over of last year.

and And get multiple said so right? we’d need them We But scenarios the proportion and the for the two endpoint, them, to to To their what us like are on those end said or discussion an product. EMA. they question of We we’re alive your agencies multiple We’ve had unequivocal liver years, the endpoints. that talk track. to have right want. about about different patients both we’re approval it’s doing regulatory wanted to of this with that they endpoints, of FDA simple, pretty and a at

about sometime Bylvay, of looking potential BOLD full and this the treatment atresia So for we’re with excited announcing we’re to the the biliary enrollment trial forward pretty patients of year.

Tim Lugo

All right, thank you.

Simon Harford

Welcome.

Ron Cooper

Tim. Thanks

Operator

Thank you.

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

Ed Arce

Great, thanks my for taking questions.

Just a for me. few

how impacts and Firstly, pandemic any thinking projecting just you're the COVID through ongoing wondering XXXX? from about

Ron Cooper

think, I businesses, is Ed, of and right. our part of our COVID part lives Well, just

this we And delivering had we doing had and we've this as and just you've as able launch. if history deal of as for we what that. bring to this for So and in as have seen well. in sites BOLD prepare team we in We've focus And try background the plan representatives on it, physicians. enroll out reaching the the We patients as background future think this ASSERT as in to We've with the planned. right. in that from our organization, had the And tried I look on background at up to you try we that and do on been we we've and is been that executing. focus this

Ed Arce

to, significant change? sales? everything I pandemic. that increase later right, expect the pointed expect of sometime say, hope year, there's this up many what from else getting from ultimately and in, any you course. could a Thanks. as sort that discrete of in necessarily or Would fact, Any step Right, to be if, prescriptions of Ron, people perhaps is guess and I'm diminution of restrictions sort

Ron Cooper

Ed, business we of don't be No, usual. any would expect it sort change, as

Ed Arce

you did a think gross to expect sort from And I inventory this the you earlier quarter. the know as mentioned Okay. that that newly But manufactured of is to product. And is would margin, about then how I think Simon through out this you COGS wash normalize reasonable XX% when sometime COGS assumption? wondering build year? likely to

Ron Cooper

So say the following. I'd

will really components. future fixed product of new road you be If But think And this made people, a and those made to the this that's is lots number our up COGS of that obviously, COGS. prior get that to currently headcount of stable expensed stage in using sort zero. certain is are a of down about what time. in product material quality and as of of individuals material One the you at at material to we is a are that the up costs revenue material and cost for with we costs are, It's manufacturing remainder up reason COGS. product two allocation costs would key point because made ways the allocated The approval refer to a – currently. are relatively

an revenue percent headcount fall it goes and need margin as over your a haven't XXXX. in but expect something to manufacturing suffice to revenue we costs, by question, about rare that's is clearly, really But definition, given that say Obviously, given disease up, worry allocation as of product. And guidance, So you this explicit relative not longer-term would attractive to of for price. time. fairly a to to you allocation we're giving your

Ed Arce

the final revenue. Right, question Fair okay. enough. a And royalty on then just

quarterly your retained by million $X.X Pharma. the correct? milestone believe I But to over turns revenue is that course, royalty EA Is you. Of

Ron Cooper

that's No, health passed not a on care gets to royalty That partners. correct.

Ed Arce

Okay, great. Thanks much. so

Ron Cooper

Thank Ed. you,

Operator

Thank you.

from Andreas Securities. question. with question Argyrides your Please Wedbush next comes Our proceed the line of with

Andreas Argyrides

Good question. thanks my morning for and taking

on that for it XX patients me How patients, added going year? to So you like new that rolled remainder not on identified you or the well, about thinking are XXX you originally let XX from – of drug that as over phrase patients rollovers. the were Thanks. the looks – those the

Pamela Stephenson

have, approximately trial. right, they're patients X we you patients commercial most enroller And of off clinical rolling we've moved drug, the international as worldwide. patients the so mentioned, Andreas, to on already as are these because U.S. mainly PEDFIC XX

to commercial product over of the in So each a large reimbursement to the of are roll as is we countries. who ready number patients this drug be on upcoming who would get

the reimbursement So excited as number about hard very working on mentioned. we're that and negotiations

Andreas Argyrides

Okay.

follow-up. a just So

our on? fair per guiding it patients or is pace of Or patients assumption? can't quarter, guys to these how You as guidance provide any adding are XX a Or – that is estimating you that?

Ron Cooper

comment get those the of made Andres, to right. Well, countries, it reimbursement and sort Simon connects to really earlier, that we pricing in need

So be roll summer the the a of XX the would that if versus over a difference, the we patients quite in part say, of for versus fall, large were to the get in the example, fall was middle reimbursement are relatively summer would country the that Maybe in country pricing that and it in quickly. right.

on very have Pamela indicated, as which, we reimbursement, is by sight until of as well. line pricing So and the way, going

of really us we it's occur that of when – expect those for sight that, until to have predict and patients how to We how roll line those hard over.

Andreas Argyrides

another to half the population Do your of as year, rollover second the at in year-end patients just you come are anticipating part outside Are rollover? – Okay. this that. on? of that those uptick looking of you to you And then the from follow-up forecast, coming the

Ron Cooper

drivers, all Well, right. three

we going us, over patients right, patients first of So to that on, grow year XX time. exit are for the the value the those driver

going to our and deepen in The Germany where is the penetration we'll second U.S. that's access. continue occur we to thing have

countries talking rollover other is those been So about, just commercial. the that And right, third we've will time. reimbursement the and and into in grow pricing patients driver of over XX

Andreas Argyrides

back for the get thanks right, I’ll that. queue. All into

Ron Cooper

thanks Great, Andreas.

Operator

you. Thank

is with question line follow-up with Jefferies. question. next your Please proceed Eun Our the Yang of a from

Eun Yang

I you. Thank two have follow-up questions.

before off-label approval expectation usage of Phase more expect question clarification. So some Alagille time approval do is in you data this expected end What's in line? And year. XXXX? is current of then by a And the syndrome second X for kind

the drug? you. number who that does So for initiated are Does year, represent Or the the of patients patients of last drug. on patients the Thank there who number XX discontinued? exclude that

Ron Cooper

that and take little second I'll then talk you ASSERT? a question, about don't Why bit

Pamela Stephenson

Yes.

I'll XX patients who of that as the and mentioned earlier, asked bit some considering I it's patients of handful, metric is the discontinued. in have So question inclusive that take a second a restarting. was you of And these is dynamic the are patients a it

Ron Cooper

on pretty we're Then going relates to ASSERT, it excited is as very well.

Europe, We ASSERT Alagille the line. time filing supplementary a the a in expect the quick relatively and U.S. The with variation by end will in so data be the year. of

already promote As off-label a Eun. expect, received Albireo, number prescriptions physicians. not questions, anything generated do we but we've off-label for at you would the of by Thanks

Eun Yang

Thank you.

Operator

this for question-and-answer gentlemen, and Ladies back to any concludes final our session. turn floor comments. Cooper you. Mr. I'll Thank the

Ron Cooper

hope continue patients to a community. Thank and your advance our continued of to you thank for thank three conference drivers you attending you, updated I and and have all great Albireo's on to We'll operator, all day. as support, we disease for with provide And liver you the families today's call. keep value liver entire mission

Operator

conference. concludes This you. today's Thank

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

Albireo Pharma (ALBO) 1 Mar 222021 Q4 Earnings call transcript