Albireo Pharma (ALBO) 4 Nov 212021 Q3 Earnings call transcript

Good morning, and welcome to the Albireo Pharma Third Quarter 2021 Earnings Call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to your host, Paul Arndt, Managing Director.

You may begin.

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

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

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

launched deliver as proud our is our and the we and and are Officer; Paul, first I'm you, achieved Commercial historic our product of Albireo Harford, Simon Chief Officer. today successfully in for Pat to this and our Financial Chief U.S. planned. and as me Chief ability Medical Thank thank Pamela This With you, approvals us everyone, Horn, Europe organization's execute joining a morning. Officer; Stephenson, our quarter for Bylvay. Dr.

approvals ASBT X line you Phase for to the and PEDFIC go of half starting XXXX. clinic mid-XXXX. X to Bylvay Atresia second the X committed in data top enrolling committed We we studies into reporting additional We We back of study committed the in Biliary to generation the Syndrome in and launch in half in XXXX. If to Phase inhibitor next committed the and Alagille year. a the of first time, taking in

generated X Bylvay all new we're to We it option. drug going expect commercial expectations. countries, advancing and team sales point of impairs for and delivering our plan trials we into Phase international and and EU Bylvay received is like and a product in the the our next-generation generation U.K. to to starting sales with and launched company. the a We Bylvay fulfilling recovery also a on as the this not U.S., us globally, commitments same Bylvay and of revenue delivered Bylvay finished success forward. and which quarter company. only partial these and transformed pipeline with Delivering The planned. commercial but and U.S. in In approvals the for have quarter right well we launch goods Doctors we compounds. first looking on Bylvay in and X is generated for build treatment fast advancing we're first delivering launches need Bylvay forward is on market to deliver clear uptick. Albireo great delivering and the journey just more We're clinical at the launch going

of of the planned and unmet hear geographies across Focusing impact we are Pamela and a need the we the status. lives and will as types demonstrate the going is stories provide on Bylvay. picture and The launch the launch Bylvay, PFIC clear high impacting

with Bylvay for That clinical have various providing hear a these and to to have better label our for effective pruritus The as age getting from after better. from had subtype. off access, progressing share relief you and today we one treatment two long example, For hasn't will medications PFIC-X years. many the XX to of they're option. and and programs the children been pleased better years launch X is of living siblings, rare new with things keep age on unreleased Both excited getting symptoms pipeline. is theme so am the to been I

financial as will and Three, our actions progress of launch details update our global with by progress call the penetrate share These that the two launch. the approval right the an useful on progress. We Bylvay, to determine too estimated provide Two, patient fewer the several to basis. we share with exciting one, many term and taking to metrics. metrics you the we this And on on suggests near the Bylvay opportunity. of balance since X,XXX pipeline. the quarterly through most you covering stakeholders key ongoing four, is launch, Starting of first surveyed PFIC stakeholders

Note In plan forward. going to provide end partial Our update. be our time is would quarter every the that to quarter This quarter. the is approvals update given and this this quarter first an July. explain first of quarter a the and take at each metric metrics occurred will

it Pamela explain update. an and the will to metrics turn you be over Pamela? me provide Let you to sharing with

Thanks, Ron.

into there unmet to is the as and difference. Bylvay payers prescribers, I is and jumping going I of the metrics, comments. would reacted is and launch making like Bylvay Before patients some Bylvay. To-date am significant clearly delighted reiterate response a as planned, with have availability of to to need Ron's the a positively

very be to we as especially continues deliver. positive, outlook Our

our X,XXX on executing U.S., world. the to across patients against strategy We the Europe are focused of reach PFIC and rest available global

discussing led the prescriptions starting treatments. benefits and payers patients generated Our and which being to field teams have since with has and been of Bylvay, value meeting launch, HCPs

each our process, prescriptions AlbireoAssist the help drug. all work on them continues of to have driving Our patients family in-house team which getting contributed and navigate in reimbursement to with to success

of U.S, patients in many has number international these new number prescribers out net Number There million So managed number of we the of and of potential basis. going in by reimbursement in and patients Number total Bylvay. will are still sharing revenue multiple revenue. Number third and XXX tiers and there revenue patients are in build net patients exceeded The what in these patients of Bylvay been proud our managed they These commercial unique will of way has will level was includes prescribed $XXX,XXX. period a potential we that I U.S. was sales new programs. is the we Again, access for the we achieved rollover XXX. prescribers a The in shipped. is have product to on program XX metrics complete prescriptions remind and first that the the access patients revenue are shipped. an are patients U.S. the the the PEDFIC and ongoing of product well $XXX,XXX X are pricing the prescriptions our are achieved following: $X.X obtain process. physicians or XX global and convert and that on with was This we worldwide. are the rollover number the partial Total commercial patients Bylvay or through in total in Bylvay quarter. when for are be U.S. key new QX today Bylvay prescriptions and reimbursement these rollover at been number which The when on study I U.S. patients through reimbursement Bylvay will of to growth. patients are This on on where will key on million in where XX-week of as number a of Again, and to international but you X to and of study, base updates our Bylvay where have net country product It on am reimbursement that of potential programs. how study a for which prescribers and they quarter, of extension as discrete this split to their these the continued our should is quarter, patients the with clinical are drug access achieved it generated future. is programs provide patients early access is commercial early globally enrollment sales the some PEDFIC

transition prescribers in The the drug. to commercial discrete U.S. is will XX. number they of So

at top a ability of to tier the we and don't exactly call our this early this where expected detail this have on track HCPs, XXX whom targeting This in pleased and I disease We on a but our have We Europe. I start the be am to and of be that launch. guidance P&L the stage our time. have delivering time, XX we and I'm In low and rare into with generating. single-digit With each allow sales at target in more revenue to U.S., turn worldwide, mix day, option go and representatives will HCPs for access to treat over to confident pruritis with us we minute. access the of will this This the the more prescribe now leverage patient in approach, the patients a PFIC. and U.S., will XXXX. sales ability and and which means who to more we drug physicians increase coverage have with we is

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

resulting reach the identified patients. the and team top our who we adolescent Pediatric teams and adult reaching quickly treaters, and specialized are with not their to the field with XX HCP are adult GI's community and our the to Our with sales which and only but outreach is the at centers do And team's We centers, referring reach is field to the delivering Starting that. the job treat continue working teams to also education, hepatologist physicians in patients. medical prescriptions. in is

target our physician and with are We are to VR extending universe our reach top as on on patients quickly calling targets, to partnership whole also XXX as reach but many possible. the true physicians focused as of XXX

are disease work could on are do be going versus patients the that? estimated who transplant. have to from symptoms to categories years then diagnosed. treated. ready rare patients advantage the to is and we where potential and available are finding diagnosis So getting patients for Good focus slated those disease how you the for through in Bylvay newly And This ranging big X,XXX other this be the a patients then These take have But to us we news. globally. diagnosed system in category, to to

kilograms. We are a six seeing months to weight of and going XX years a range varying range four XX from as to weight as young of old, age and

and getting from are coordinators Bylvay. In care hustle AlbireoAssist our addition to teams medical our key field on to focus the commercial and patients

well-coordinated a requires intensive with case always high families, to It As is team for pharmacies and follow-up in-house fulfill Bylvay. of payers, from specialty different the and patient the it our little imperative lead physician to each been touch offices, a approach. next has process

receive reimbursement them have are To access on some as are the pave as We Bylvay. teams quickly two been as private week with market PFIC for seeing as others the access prescriptions for and in way U.S. months. working progress whereas public after our insurers written long educate one they in and are patient to

are success medical being timely patients in as getting We for Bylvay having prior criteria authorizations eligibility with to are manner a defined.

and reduce and time reimbursement. processing of to an had process, mandatory Bylvay. by Medicaid finalized to we first to our with for X, learn agreement care cases the doing we but each coverage date August the coordinators predicted Medicaid providing October families at Because are a case support patients job took burden we outstanding As of our

have coverage patients. example, pathway to to For Medicaid a for New are pleased we York

clear the of system. days payer patients our to to requires of feel state-to-state families allow the is getting in through that team and to Overall, new still we pleased it flow response with for track. Bylvay hands expected, the the are work on approvals As way to a early

where reimbursement looking of the in European U.S. many dossiers. markets, Now Europe submitted working are remaining we outside having on the

many of reimbursement well in and discussions simultaneously, countries markets. with and authorities are pricing these in pursuing and our are We actively XX advanced

accelerate highly technologies HST Fast specialized wherever SMC the notably leveraging Ultra-orphan are France. in the nice in in pathway highest reimbursement pathways, Wales, pathway pathway the Track We possible Scotland, to seeking optimal by England or and and

will reimbursement reflects value ensure access the ships will named had authorization price European world, while routes prevalence. a of commercial we with to Bylvay. in we variety Our in including goal programs. that regions patients patients continue high a parallel, opportunity Bylvay more of the The enable of patient achieving is globally. to to initiate Bylvay is global us access the can and rest to a allowed patient add that patients to that distributive provide who Similarly In access access countries the managed program to at through

our as execute in into agreements availability parts for create Ron existing have really all we to a to strategy will we excited completed Middle market all and with agreements be rare eventually partnering adding Bylvay of as Jadeite supply regions and about availability. continue and Another the BioPharma in development, significant in and key with Arabia pathways a various distribution which regulatory to-date to with fifth Japan, Eastern and continued we deliver on enter are representing with opportunity. well five countries, Israel, East, to Japan extend Saudi markets of But deal and expand Europe, responsible just shortly. Bylvay APAC global Central is this as the to clinical exclusive on Gulf we across and disease plans China. for commercialization the We Europe, other announced will approval Medicines Swixx LATAM in of companies Turkey, who and

Now look the on as market, our larger to we an me turn back cholestatic it pipeline. let Ron liver update provide to at disease

programs. more the generated we Bylvay thanks U.S. high PEDFIC immensity the generating Pamela. X value data. commercialize pipeline of with on analysis do long-term Phase share Europe and our of and data PFIC continue around we'll Starting the the to from of further towards based PEDFIC and we've results And and studies, translatability ability Super a in approvals have study of in the Bylvay at NASA regulatory reductions improvements level in bile the the successful world improvements The as year. sustained upcoming in across ASSERT serum safety show NASPGHAN efficacy, and syndrome. Pacific well and XX in including on the symptoms sleep that growth evidence the presentation this burden Data with presentations long-term of health, will Alagille data, pruritus a acids as and types. AASLD PFIC hepatic and reduce disease, Post-surgery to

X Phase line ASSERT top syndrome Our remains data report pivotal study track to Alagille in XXXX. on in

to positive placebo single randomized, we As be approval outcome. which blind, the sufficient controlled double patients, FDA enroll with that EMA with successfully and a agreed the also trial a for study, continue both will it's we've

the we've Our trial in with EMA largest line is is study, Phase second and outcome. ongoing the both with BOLD double-blind, and with Bylvay be positive remains BOLD tremendous controlled study only which biliary BOLD would X the atresia, progress placebo Bylvay approval XXXX. FDA atresia biliary study that track We've pivotal and agreed single and of the deliver sufficient on a for made to top data in randomized,

with beyond programs we first world's candidates than with ASBT Acid inhibitor. generation will Now and adult advance to AXXXX inhibitor, act we pediatric which next disease our modulators to product bet bioavailability Bile to our I AXXXX the high AXXXX liver believe systemic have n continue differently

and acid to effects X such and and we We results Phase PBC, differential eliminate year which liver end. have PSC share now the bile from ability effectiveness study, static in cola are and demonstrating the waiting presented preclinical plan to disease before data as AXXXX NASH urine at

entrepreneurial for AXXXX is and X finally, €X Our company, inhibitor second been Why? dosage in the to world's a and right developed with solid probability in CBC the the has to for $XX AXXXX daily AASLD deal is liver for approval NTCP have We've NTCP cholestatic has was the market, which completion the Japanese AXXXX QX be purchased Gilead at this IND the of $XXX we was backing $XXX trial by convenience. got is upfront viral Pamela about financial overall navigate an with as with billion. a Jadeite mentioned deals Bylvay been partnership the poster inhibitor, million spirit of first agent given their a must potent and preclinical and encouraged FDA by the also enabling received payment and financial to a anticipate milestones continue we with double-digit start Priority entitlement and capital give us expand at oral footing, Review worldwide. the product of compound. it success attractive stronger as candidate value deal, team. financial approved this Group. work subcu. Jadeite oral studies a the million the of we continue to Hepcludex Jadeite more financial a to optimistic the look availability strong But and about of completion sold as medicines. the Voucher a continue of peptide Then as diseases. non-dilutive data be only XXXX. progress to Phase And Jadeite for We'll Japan we sharing royalties, presentations. allows orphaned agreements. of million. in The beyond a An range the both better wider from with knowledge position in What strong which two

a company pipeline. candidates and a We class strong in other product with first with to market first the in are

commercial, modulators worldwide Our adult ASSERT on across and $X parallel AXXXX next or our viral allow focus our liver Bylvay the cholestatic in to of that acid our global generation and launch our advancing with trials AXXXX potential with of and us and realize and billion diseases. BOLD for Bylvay, bile aspiration diseases is liver PFIC availability

to Simon my So with for turn call pleasure that, update, to Simon? a the over financial

you, Thank Ron.

XXXX. for for partners. royalty elobixibat million of the in for of analyst of Pharma as be Let and line increase third was revenue manufacturing XXXX million for to in on launches international and received Bylvay U.S. to results quality due September. included now the and know quarter the to Cost and revenue royalty of was quality third to $X.X U.S. quarter healthcare in EA you following million Bylvay or quarter $XXX,XXX. from was expenses. an was for $XXX,XXX me which third $XXX,XXX passed estimated revenue Royalty for relates revenue $XXX,XXX. headcount of The $X.X was in the to product ex costs, in approval in chronic costs prior manufacturing international compared revenue were the third quarter constipation, financial quarter for XXXX revenue with increase the of headcount U.S. treatment is $X.X the the review our third consensus July to

revenue. a cost portion However, since now of approval, these are in costs recorded of product

trial headcount these loss early The Bylvay. our assets. to Net administrative headcount we of is an XXXX during continue quarter the sale million quarter $XX.X this the last XXXX. lower no $X.XX As commercial third research the ASSERT million. expensed $XX.X as the costs a driven expenses $X.X quarter for to X to increases the third loss for to Phase diluted decrease per principally investments of same in decrease of increase income X this and the for one-time to increase as and for There of expenses Bylvay a of NASH revenue third one basis, of share third $X.XX for the last $XX.X were expenses XXXX, quarter of of quarter development the priority PEDFIC development trials material completion compared expenses and voucher, $XX.X and the for compared to the were to of million review in and million on year to increase for third for a elobixibat compared revenue. much the quarter prior related $XX.X period $XX.X quarter, BOLD the will year, Earnings were in Selling, due expenses become for XXXX. of were of current the by Offset completion up, materials ramps general year quarter related $X.X product and XXXX quarter of the in million. in third with of XXXX. of were were by fully was QX costs percent and approval. XXXX The the of to Research attributable and personnel launch million net the third the product study million a Bylvay million third year, a compared

we had expected XXXX, on to $XXX June XX, XXXX cash equivalents previously million of $XXX $XXX.X compared The $XXX and burn million, $XXX.X to million, operating is and September million been to now XX, cash for of million. be As has to guidance closer XXXX. cash

During of after fees the $XXX.X deducting proceeds PRV. additional completed from XXXX of third sale the received an quarter million of recently the net were

we quarter $XX upfront In to additional million agreement announced due addition, of an the recently are fee XXXX. licensing Japan fourth receive from the in

dollar anticipated asset XXXX fund be Bylvay result, portfolio. a of early and ensure With to from sufficient In be consistent are more to revenue stages low over X next X millions. to previous USD the call let me of the million, Bylvay to be million cash equivalents the digit back and order USD closing As the fully expectations, to for launches guidance our anticipated turn is Ron cash that, of specific with remarks. and single U.S. clear to

toward. everybody you, Thank accomplished months work remains Ultimately, continue first in keeping And diseases. the for cholestatic we're first viral for thank worldwide. and bring approved opportunities world. adult finally, we've joining the drug liver goal as the We launch of the types pleased all proud Starting to and option portfolio XXX,XXX now the to Q&A. to call And to the patients us. We're Operator? our our of advance continue two approximately only pediatric around patients Bylvay we'll across and in Simon. Bylvay we what for open

Ritu first Cowen. with Baral comes from of Our Instructions] [Operator the line question

proceed question. may You your with

reimbursement I the launch is itch What wanted state a be, do like guess if it like station? authorization of to any, most exception? or any for lives expect you're the promise. covered I got through right I I've a percent requirements pair level now you on diagnosis prior forward at to And And how just follow-up, the or acid tell plans you then steady asking like looking added can Thanks. bile us common focus quick going discussions. serum certain or most

confirmation question. we the the requirements Many be we could a seeing that plan bile plan the pruritis new a system. at of vary And and to baseline prescribing for authorization been product. get initial would we're expect it's you prior with present, that is on everything specialist levels, prior these is It they thanks able whole we've of Yes, all from through see you what an to serum that authorization range Hi, Thanks. factors these mentioned. Pamela. with looking confirming

about the across And to know, system can recognize they on going around really as through to is with they covering the understand the Bylvay been why our getting the And prior sort been say of question a positive and date the of very we covered barrier, Albireo barrier and and gotten second for. of, we've what work any the the have authorizations, paid to through plan Bylvay. we're value patients requirements, U.S. You expectation take of new the process. I majority we again, and the and to cases have on payers, the product But have or through the get able approving lives. percentage is represents We a are that's not in, to the assist. on all understand patients XX% not And the claims system out your lives I believe exception we that

and how you then, targeted on Ron, PSC NASH? quick and indication? might on know, And thinking we like, XXXX. question need a direction you a into unmet about PBC the very versus expect the established are path When

you for the thank Ritu Yes, question.

being excited first you the that compared highly believe some bioavailable think ASPD we I systemic with exposure it, bet the the inhibitor [indiscernible] can know, because pretty to inhibitors. we I that about probably things do with different XXXX

with to answer we'll first, really of, the X through believe Phase need to continue adult acids the by it's your for we body, data take but the take the chance the to path data Once end about but them I the also of the out to a interesting. anticipate the that the think which because year. ileum, only could we sharing we through question, chart in not liver we through have profile think, range the now bile to get we kidney right ability of you digest be very out to diseases then

Our of Jefferies. Yang with next question comes Eun the line from

your may with You proceed question.

So on from know have But in terms pricing differentiator know so that of be potentially and and far, the U.S. do ex-U.S. different pricing? you the could the quite country pricing, your your basis. between could experience country - by what at same the ex-U.S. be I discussions time

European with of analyzed looking for XX% that rare at in quarter which are is we're - disease list line Bylvay What and of seen whack analogues our we've prices U.S. right to the that within our the XX% is today.

our very in and feeling pricing So we're confident both about strategy the U.S. Europe. in

in or lot that's the PPPD outside And a U.S. surgery the Europe cheaper.

payers seen on of sort So from do U.S. and some the any you differential pushback - have you Bylvay? of outside kind based the pricing between surgery the

pushback that seen to-date. not have We

option patients. the for really I see of value nonsurgical a these having think payers

syndrome. last then allergy question on And

data is track on XXXX. So for

think this patient of The in year. first dosed March I was

complete of a you you comment. us bit some So But to can might maybe to it's kind when Thank of the little enrollment? give you. guidance patient too early expect

Eun. Thanks the question, for

with once update assert we're expecting to we pleased with you an trial, And in the thus We the study up data fully our going enrollment XXXX. and enrolled, the guidance are globe. the far. reiterate across be just provide but really have pleased we We'll

Our line Piper the of Sandler. Yasmeen Rahimi next question from with comes

question. with proceed your You may

are Europe which to geographies others that as going again at cadence could us easier gain access bit in dossiers the Europe? my orient be market about some coming of two for then just have part how be versus you would thinking little of Simon how second U.S. the the of looking XXXX. just one. understand also help and the of And guys for and, quick But us kind sort taking color, and of guidance much a help European providing be you in for question. question questions you. for is approval versus sort And the I be contribution us can matrix maybe to you That's to from thank kind launch? we give filed you of thank are

to The year. was XXXX million revenue for of million actually this $X for guidance $X

you in anyway balanced see It's but of sort XXXX the quarter, it we was currently, As yes, because a relatively guidance give this and frankly, split from to Europe till the was premature stage. U.S. QX at between want partial can the better the wait it reasonable we year. assume EU fairly for U.S. the and sort visibility have I the this world when end of be numbers of the the year But of and will a that it's split rest the between final think of balanced. to to

your the for regarding in Europe. question, cadence second Yasmeen, then And

know, as, we're the actively in as You reimbursement what of seeing countries pursuing mentioned, submission with the we're dossiers. the XX

we And this largest think in opportunity. about at Italy, Europe course, there's with the Europe. way in submitting time, so we've those U.K., Germany, lot of markets and We're simultaneously remaining actively dossiers same next launched the well. the we're as in And in then markets discussions also France is, of where the a

given to follow-up, on next is able have to you And of a maybe many of there by Like by like, to a a with being complete mind you you sort that share just when timeline yourself the How us? wanting that feel dossiers? comfortable sort quick timeline XX in have complete?

U.S., this think about the think year we of Yes, in Yasmeen, the about kind way through I think logistics working the is the launch, right.

the As there's XXXX within different about in you know, payers U.S.

Pamela about with really comments, particularly at access. So U.S., then we're pathways, and in stated a the working specialized some this perspective, right. the as as European year through And pleased the logistics in next is looking assessments, dialogue, you the clinical from think us of were European early the early

sort were pretty that through we'll we confident countries. next European through So year, those

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

with You may your proceed question.

for insurance gating stressing for on launch into the x that for the identification that then, taking on know the sort waiting or just or that doctors cycle. adoption, comes comes until negotiating is coverage, and the getting the was as for What I of tight of wondering, scenario patients get cadence patient XXXX what patient is bottleneck main of are And patients sort to on major visit thanks to kind are routine there? that the the going you timing it on insurance - of drug? the lot a in to sort about that questions. There's factors situation and factors getting Tim, of more drug, topic gating prescribed, probably was I for

they formulary in guess, over and be significant of really going sort course the XXXX? a XXXX? of you improvements expecting, coming are online Or starting to So effect I the year in big taking

start question second and your around first. with to Let your then loop me

to reimbursement. this, cycle terms as is really for the we're this the what by we is that case the go In payers, case-to-case a of approach through finding U.S.,

been course, side, little And some coverage, of had, we're Medicaid October, of as And, get pleased in their there bit, to on so that being the of and I've a so very to are drag mentioned, but patients on Medicaid. we've getting able into as getting we've states terms cycles.

should, to added commercial And are standing there the are we through formulary. for having able necessarily get Bylvay Medicaid. good so we then we again, piece, without in patients to with And

will time. then through that factor of think in don't at them and I in gating in as case-by-case and patient, in in XXXX, process to are prior to get cycle we're and terms type sort doctor's by patients able we for in type patient of through that waiting the them prescribed of back a assist we've the product the treated, and And be Bylvay. any of any so shipped Bylvay working patients just because getting of authorization what to prescribed a they actually then and of system we're process your the this terms So first mentioned, through rail a are out point the is on, step steps And the the to once identified getting new, the they plan get has. take a sure to and Bylvay, requirements then throughout or thirdly, make either in office get them into the it's get working and first question the

be couple it's can a time. of can just So short take time a that or factors can - longer take a

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

You with may proceed question. your

I'm it the how the there steady Are of think or build like, of an a Do of are of vote? up? authorization as seeing early there think any state flow going sort this just seeing to we nRx kind trying anticipate should about forward? kind differences you like Like you about And quarter lead where get a on acceleration pursue here. And that TRX doesn't actual ultimately anything converting to treatment? attrition where you an any is then to and patient nRx? a could the an examples here isn't patient nRx to Thanks. within

Yes, question cadence the of the the to sort on first your nRx. for

of and, patient. patient on through come And it's sort come patients the and by seeing system. are We

it in work a faster So I familiar time them of continue would in that work get I their into expect terms cadence payers of here, especially more to become going bit Bylvay to as through. we that, beginning, pulling the But with as the takes we'll process. a patient's to for little grow, - out was

think we have a coming countries I also patients talked thing XXX board. about to the that the are we other new will is about on think right. convert, talked that from perspective, And we Brian on And Rx that about drug

come different So these patients right. countries, as to well, of would period, XX out in week we and convert as as the get X PEDFIC people commercial access

had you them. still have we that's we going help So - two continue had I the other your certainly it's to we're of many that's question and to as still rejected, we're process of with about the to we going really we're board nRX with going think, first have, quarter-by-quarter, geographies in grow, pleased and what months on had to have no we're early,

we're confident of some So get there we'll time. we'll wrestle longer, pretty continue them taking of to over but

Our Company. next Joseph with & question comes from line Stringer the of Needham

with proceed question. may your You

my question. taking Thanks for

cadence your wanted are drug. a sort transitioning, a either it patients you. on of, bit in specifically or follow-up the of onto Thank sort just and you XXXX, whether Bylvay commercial transition and that expect of get X, we of be mentioned Ron, transition, to sort little slower or to from patients the EAP of on thoughts can program to on X the PEDFIC drug. any Just commercial PEDFIC would

talking Let just of, or a patients way one of study, either potential start they're manage rollover mentioned, had these we they're our by a patients that early me we these in enrolled in XXX access rollover are little and or bit our reminder by so potential as through worldwide. clinical patients of access programs. have And sort

different off have lot and a lot countries, we to periods. programs of and XX have we patients weeks rolling And of a so at time different

they So our we'll coming say time, as managed what we is on that weeks. have have access rolling At through programs. patients can patients the same XX hit the new I off

this sort drive I coming commercial steady of So state on through on an year next we'll patients see of think over so. the to or

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

question. You proceed may your with

for thanks our Good and morning, question. taking

But guess, I - compelling. for pretty be I harping status. a reimbursement and obvious think process the small just of is the there'll kind on apology profiles what

essence, so, releasing when this And you to so maybe it get do payer take does do or you expectations number a the put perspective to lives? or plan in the to what really have And you that? to of on convince certain are from to as formularies? their to that what on And them internally get press when covered

couple So of let questions with here. first start me your

they it it manage like don't closely. this. such, value, closely. they you need, it is compelling not the too really unmet any know, to want this manage patients they And So, for rant, profile pay as a for it's see There the understand disease. they rare of to and is the worth is them for want to very Because payers, number

don't we expect just lot to even because Bylvay plans be will policies place in on covering most a coverage these of case-by-case put basis. a of So

the So and submit to we're that able for they get get to it's office, through Bylvay. for paid claims hard through, not information, specific them information, too physician's asked patients and

know, is, lot this you a where massive think think with lot a you important is about your have, think These a of medical products, of know, an And is right. rare a I And that this one is case, But primary leave. you a are metric. large suffering, have about of insurance patients like the a metric coverage this when lives rare prescribers, you companies, care disease right. you in Andreas children to are disease, unmet things

as And a compelling prescriptions And worked the is that the put that so for patients. gain for value we're pack handful are of the an has said, payer, - we ability in reimbursement pretty our have, continue that confident individual to Pamela thus far we this data out, to together plus generated.

through ongoing efforts far then kind patients Okay, process? identify could know, great. us as And you walk you that to, as new of

course. of Yes,

prescribers. XXX% patients reached centers top XX% terms teams the and of top have and of are So in Albireo of field XXX identifying the Travere XX

either with diagnosed doing And patients in system. of these HCPs to or So in identify really slated able from range the we've being been for this, can course those quickly transplant. newly potential patients

and continue who NASPGHAN. upcoming to we that virtual get to new the engage you communities to building educational with as So And ensure know, who, of ongoing been treatment AASLD and sessions we are have engage patient working also advocates was options. & with aware at their meetings HCPs opportunities in-person virtually have we

we're and into absolutely the for system order with them the Bylvay. bring efforts, these bring in to them system, all through So able them patients bring in into identify new and treatment

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

your with proceed question. may You

very metrics It's of my launch here. Thanks for And helpful. taking you that. question to first for all start up wanted the on front questions. thank I

You new XX and prescriptions mentioned patients currently Bylvay. XX on

different as you have doc's thirdly, you what much. then first mentioned dynamics and remind in few So that very that accelerate of proportion these you're I'm prescribers discuss itself, of it multiple seeing project months pay over timeline, success question? that strong the you're you which that, of us, given between right commercial is you to is written AlbireoAssist? now, view the And a already that's Medicare high Second know, know, prescriptions. Medicaid. could the only if if But terms would is know in Thanks the know, in so you value what with two of you remain prescribers stable, the well? U.S. you through going representing you one XX you accelerate, testament conversion, any with, on - first I could the and discreet wondering, appear something proposition there's also not approach perhaps XX% could time that just prescriptions conversion the expect touch or first a to but Wondering Bylvay

new patients the that, say would me I on Right, on is prescriptions, conversion. result. start let very with XX Bylvay first XX that What with question here pleased

You know, those in come mind you in, right. would QX, patients, have prescriptions keep of some in those late

And so are patients I XX%. rate in numbers over the use a because may the the and coming just course quarter, the of of that right. there's forward, conversion small, not they, going are mean, I

expect see time can - longer we - more higher forward going we to period patients. with a think I a So conversion rate over

one that's So to in mind. keep thing

the we XX here the there, dynamics we're what really really prescribers, see on the that pleased with of question right. second breadth and is, prescribers The

top - the XXX that sort of and we about the breadth a prescriptions U.S., prescribers a here number rather the of think you small of more we're like from If prescribers. - have than necessarily, number at in coming looking of

question? the So of see to they your then were breadth and final pleased really prescribing

it? was Medicaid

I payer for right what for line is will is what comment But the to on us early too in drugs. Honestly, disease mix this. - expect rare say we with

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

proceed your question. with may You

talk I'm any follow-up. from you prescribers. have to trials? them bridging navigating drug place do patients already of the on early exception and are just you free are curious, or reimbursement experienced can the in then while of Bylvay The Thanks program for also what and taking - Thanks. XX the clinical percentage new

Okay.

the to Let talk program. around first the assistance question me

a we So wide support through range offer AlbireoAssist patient and do of financial programs. assistance

authorization series prior patients a we our we get while access through assistance a our program navigating programs, free we you lengthy patient them for program. program as help for of called that drug comes in, a including a patient are temporary say, when other right screen So And process, particular have onto away example. can, then drug

possible. as on a your of build the offer that do different as programs question second help we to Then to yes, range XX…. patients access ensure quickly So on have assistance

Bylvay. with Experience

prescribers, prescribers we our Oh, trials. can't But we have yes in those as well. their with on would who of of that, clinical seeing from yes, are you can Bylvay. Yes, - say as we experience mix experience prescribers top as who what comment really are is know, Bylvay percentage a new with well exact the tier,

part, three or Because clinical is we're of either awareness lot three ongoing of think Bylvay, that phase this given pleased level of a we have completed. trials, I high really a actually, Yes, that about obviously Ritu.

as we're So there that people to well. are lot so number so awareness is there's high actually that level pleased of individuals are prescriptions new of us aware. prescribed sort aware, a a that But we expect for who those are people that of

as So continue Pamela that said, we'll to time. expand over

thanks. helpful Really

will and At Cooper we question the this I closing. for Ron session. the back now turn end time, have the answer of reached call to over

and operator. post-AASLD Officer great, cholestatic well studies, on Well our Dr. progress join acid Phase next adult thank call. thank for with Scientific Mattsson. Officer two disease. again where will Pat Chief our update All conference Dr. November Horn liver our an today's modulators you Bylvay two Chief as XX, conference be well Medical gen keep and opportunity as call The X you will as the bile all in Jan viral our me next We'll the co-Founder for attending updated you, our continue enrollment right to global as for progress on Bylvay launch

continued you on then, community. for to provide all liver Thanks your of So support. we'll Albireo's advance confirm families please with liver calendars. to of disease mission Until and patients hope continue to to all the entire your

today's This conference. concludes

You participation day. time. a for may great at and disconnect your your have Thank you line this