a and the pediatric at PFIC and Stevenson, a COVID-XX these our the of with expansion a progressing plan. Medical Horn, Officer; With today unforeseen Commercial the we a clinical short another Chief progress ultimately and and then everyone our with giving looking companies, XXXX in to Officer; beyond Pat us headwinds, commitments XXXX challenges QX virtual begin organization And manner. growth pipeline like I'd our for like stated our against remote review year conditions by this transformational Chief other the update. and world was where team joining morning of odevixibat, with challenges. new our fully all and working to delivered and into with in adult new story advancing Thank the deliver conducting Despite persevered, rare me results Albireo's our trials we XXXX Albireo, you, viral measured successful XXXX and Harford, year and XXXX. company. cholestatic Dr. global becoming many diseases. milestones Paul. starting where other pipeline delivered Pamela into launch conditions with plan fully around constraints in overcoming commercialized odevixibat, Officer. was XXXX, Chief overcame very thank for end and the worked our under on guidance, are; we're XXXX Simon the unprecedented Financial of manufacturing you with And Starting plan and pandemic, & challenges a transformational today year our moving by business against
profile to endpoints results, those both First, Phase but hitting in and X tolerability they did strong, delivering with low odevixibat. committed PFIC. with we triple-digit diarrhea Not We've study the primary only deliver III solid a p-values were results PEDFIC with rates.
is Biliary world. always for granting announce team and the in to Europe the We're review review. our a are worked said, And We have data, disease Atresia. to accelerated potential XXX,XXX regulatory pipeline there start X and the first with in to It priority is pleased odevixibat three product we could cholestasis odevixibat that have that record a approximately were be EMA validated tool decision. liver of estimated great granting Phase validate in Knowing and will nature the of the we patients tolerability study pediatric first these decided that PFIC the FDA with disease. in easier which Alagille of back around submit believe the our the and U.S. Syndrome our we with it both indication accepted then regulatory filings indications, PFIC did approvals. precision our in result and time to the pruritis measurement the On dose,
two X insight the in liver X studies X in and and design great and have We able studies PFIC cholestatic confidence disease. initiate the to additional we're and Phase
first BOLD XX,XXX study estimated with is which disease control learnings starting program. prospective we’ve our Atresia Alagille around With from X IBAT Atresia inhibitor. our for of largest initiated pediatric committed a the outcome study around the world. cholestatic the PFIC first and program, the we year the positive part to largest Albireo an patients We world's study liver positive Biliary an year and the prevalence increase approximately placebo is confidence randomized the of in in the with Biliary and
committed also trial program fourth a to starting started the Alagille pivotal Syndrome the year. We’re last in and in of quarter third
for commitments odevixibat. our and guidance selling So development
activities, looking inhibitor, liver we made and adult with first completed Now for inhibitor, diseases AXXXX with NTCP progress expansion studies and cholestatic for pipeline we IND-enabling AXXXX our at viral our diseases. ASBT our novel
in launch hiring International, as as on well Americas our and part focused our the both readiness to with driving on healthcare regions. built perspective, their the capital, in organization and Recent non include of to progress, into our as will respective and commercialization. different into both of in dilutive put sales President financial excellent a many market medical strategies over generating engaged and execution of they've teams in the which its infrastructure personnel and From matured access plans, million specialized valuable us made take whom are access generating of successful company period President we ways of we XXXX. $XXX and and lean double of the ground company. and equity Our hires and drive revenue new parallel, size been feedback. payers gain professionals capabilities actively XXXX In We've a the
we reflect on challenges, on and the XXXX success. unprecedented also unprecedented fortunate we to were As deliver
expectation So drive for very decade. XXXX, the over of second the in goals as now odevixibat the half planned our for to year and product on billion $X growth looking we ahead we're clear
First, issuance for review odevixibat proved of a the to we're with in be Europe and deliver and priority U.S. the voucher planning sales. commercial
we third, in Payors the supply Starting we assessment we with they also the in BOLD accelerate odevixibat, a supply And and compelling pipeline and in Second, study start, services pharmacists, Syndrome. the one our plan but with and Phase PEDFIC focusing X of we're customized are XX engage the patients produced having specialty good priority chain. Europe, approvals Albireo a With We've role, priority the evidence, to a while with up approval steps in-house coordinators provides the outcomes July patients product and which be with around in in review good assert looking PFIC, characterize building the be their with are placebo-controlled perspective. commercial to also about randomized, fall ensure full date all study XPLs and we in We're with the data a program And Assist, of ensure to FDA but a rationale. important largest launch the US Phase expect value in to commercial activities Atresia further and having compelling strategy. help agreed as authorities sell. class PEDFIC competence strong PDUFA to the from product X X drug. to study well have strong further. in important and and the the study on you second in critical place and our established We've Regulatory our pipeline access for agreements BOLD access. dialogue equally our from is and access also We odevixibat pivotal The is progress care studies. regulatory studies in Alagille XXXX. with grow. us with of access positive them In next navigate we in with feel is results underway dedicated story used odevixibat regulatory enrollment a on this should plan. drug preparation, Phase half need patient can the year. the formulation manufacturing to an gearing executed launch confident plan the Biliary
the will work and shows will that native strategy, not biliary surgery which results or NAPPED part we the reduction As a PFIC for factory integrated disease, much end transplantation diversion from patients data believe access have bile to odevixibat study, survival. stage require of diversion of long-term the option. better be the liver XX benefit biliary type all acids natural depending of history a on we from Unfortunately, by XXX to pruritus
and cost initiated we humanistic families. on to measures disease data caregivers with burden caregiver and associated burden of the a importantly, PFIC, that addition, burden understand the study and In
place submission the heads priority launch. team been colon on commercialization, compiled hiring feel who So With overall, The really our comprehensive the patient valuable start and has Europe package specialized fast with next the a their our the we to this US that In highly focus and good providers. we've at are to globally. we at odevixibat sales regional is access a ensure to in prepared. support healthcare time US, focus
marketer a by a on of company Travere that leading capsules, pediatric hepatologists. deliver agreement to into are is co-promotion used have entered Travere pleased disease new we that with So and which we're Cholbam Therapeutics. rare
why long this HCP relationships the our US. to strategy? us and is Travere key standing be they'll and So launch our with a able important commercial representatives experienced are so accelerate for uptake our have highly in prescribers, help
the on our day about In estimates initial in approval, faster from result of as appropriate could how expected potential than also commercializing and our odevixibat patients will with efforts as compensate places the benefit with patients also double for for this fees our that the pediatric disease Indian Travere this representatives FDA sales start have therapy. liver to optionality Albireo it pediatric quick We calling one With a than is prescribers relationship around XXX,XXX for opportunity We're odevixibat. insights world certain as of to will co-promotion extending the Albireo pay representatives frequency give coverage and are with related its provide two representatives and and with on revenue mainly sales years will our agreement reading a more And their day they start. set per sales China been specialists believe bunch. selling in ensure on fast for the subscribe coupled planning excluding five around book with understand upon we for us odevixibat for all their aware the to this would view commercial own hepatologists and will relationship. which recent a world. larger possible Travere more representatives us another revealed what launch The odevixibat. valuable the are XX than years. have
at if opportunity Now anticipate rare US, is, for created revenue you other after for therapies, worldwide, them this just the outside of more looked larger population the we What half disease with significant many brand's data the odevixibat. launch. years of than patient coming these means a two each is have from
prevalence with distributor significant, is the with Our part to of of is sales. partnership mind, odevixibat through Commercial this opportunities. commercial multiple odevixibat decade into high countries distributorships, sales equally This focus With head in medicine, second billion $X the plan on reach a first aspiration with we international within first commercial for Israel. this and our Pharma for ex-US in a rates, US
odevixibat perspective. overall, it'll are be an partnership to go. ready approval, So for year we big reimbursement, a And from commercialization,
our Biliary development in inhibitor the key BOLD only largest Atresia. Phase Randomized, the first program trail X and is to Placebo-controlled on IBATi Moving global,
all top XX having on up activated track. As the continues We half and line anticipate data in be and to XXXX. the XXXX, sites but first available running global of enrollment sites
have active approach. For Placebo-controlled XXXX with available sites XXXX. leading program Alagille the of half odevixibat in market top we're to With in planning we ASSERT global first our expect a in for data line pivotal as three Syndrome pivotal well, Randomized, the all programs
and and we a Syndrome Alagille first anticipate being key to the US, the like and the Brazil. best-in-class the follower US. in piece countries first results therapy ex-US and of approved that Fourth with first in pending expect majority reasons Turkey, the the of a our on X to we the market study and be fast profile Focusing Europe, Israel for Europe regions Phase
up the and expect market Biliary only for We also study Phase the Atresia, because have we in X first the running.
The disease. end year third beyond by greater into our pipeline the is to expect insight pediatric thing the of liver
liver and the and diarrhea We're of We which development AXXXX, inhibitors of advancing for ASBT solving as stomach in high NTCP for properties in holds challenges, are Inhibitor. and with our AXXXX high promise stage diseases. AXXXX making Novel tremendous earlier Inhibitor such PSC. great adult adult unique co-static compounds adult, Novel is The progress especially cholestatic observed the viral IBATi availability diseases PBC a
inhibitor blocks first AXXXX should is have it a in molecule is for of was an is approved diseases. for a for dose Hepcludex, For really anticipated proof Hepatitis an the treatment B We diseases. a inhibitor into injections. commercial also good a AXXXX properties a currently could also potential. be is AXXXX X daily as with later billion. in X bile Gilead Phase AXXXX delivered transporter excellent in XXXX initiation liver for first peptide, potential AXXXX limitations planning and the this diseases. data compound viruses. But and We're hepatitis top given anticipated a phase to only and SubQ that NTCP of end over and which as study B potent start This X unique line AXXXX valuable phase Hepatitis the D D small be well combinability a with trial NTCP first in of We phase has €X as quarter, in There product significant concept human XXXX. excited of we're studies XXXX. cholestatic cholestatic has AXXXX maximum called by key an about viral and X with acids it cholestatic is NTCP developing a the adult peptide and recently purchased Europe. in the all can in believe for believe and as by entry IND-enabling year, D
to continues team research novel modulators. other bile Our characterise acid
Organisations Well the not place, our we a a building deal ability with conclude, to with do only coming Commercial our So have launching. a of of of demonstrated have a at great confidence leads but Albireo. decade XXXX spent tremendous record we successful Simon, record, in individual commercialising Pamela decade BMS. year, is and Why? our and in two our at products track liver readiness. leadership commercial and combined in competitive and deliver blocks record X Pfizer leading successfully decade we're of a we Vertex, Collectively, have global our in with Development track dozens because years successes off of have a and to market under of market. We and beyond. track, product has Albireo launches gives rare us launches believe commercialization we belts. GSK XX CFO a and our I disease programmes. read have our and approach Lilly of dozens and has out phase decades two over Starting
into Odevixibat course, no us and liver that our enrolled now bile is there's together approaches, in This adult was acids, us Japan. the for test cholestasis chance potential anywhere Odevixibat advance our has paediatric disease the progressed study in for Preclinical similar BOLD ASSERT AXXXX the Elobixibat the little in in smart that inhibitor pipeline biliary results there confidence preclinical Pharma, the Syndrome. AXXXX our Odevixibat then in We to gives PFIC. rare third for history. where design will This liver successfully the First, the natural from diseases. world on phase with and in approved be constipation chronic first atresia, study conducted allowing X X study compound phase with this modulator first other confidence approval with executed EA partner also IBAT ever will in PFIC. PFIC PEDFIC of trial study was Alagille expansion team And and and precedent plan study trial track in paediatric and our in the success records gives our clinic. endpoints, and the
billion to compounds. in our So, atresia, on overall, achieve and odevixibat, preclinical progressing progress our our in ambition analogy our we in key our promising confident $X further very XXXX we against to as biliary to taking sales, ability towards characterising deliver objectives us plan feel clinical launch
quick So Simon? to over now update. turn Simon to you it with give financial that, let me