AGIO - Earnings call transcript Q1 2022 | Agios Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, please stand by your conference call will begin momentarily. Once again, ladies and gentlemen, please stay on the line. Good morning, and welcome to the Agios First Quarter 2022 Conference Call. At this time, all participants are in listen-only mode. There will be a question-and-answer session at the end. this being that request. at advised be call recorded is Agios Please would the of Senior turn like Investor over I to Manning, call now to Holly Relations. Director

Holly Manning

Quarter And you, to Thank morning, Call. everyone. Good Agios's Operator. First XXXX Conference welcome

our Dr. by Dr. You Investors to Chief Jackie With on Fouse, section can with today Officer, agios.com. the the Chief website, our going Chief Call Car, Gheuens, today's Biller, our who Sarah Commercial Richa our Corporate Q&A. of prepared access our for me slides Medical call our of for Officer remarks Bruce Officer Executive are Chief Officer, Financial Affairs, Officer, Poddar, Scientific will Dr. Head join and Jonathan and Chief

forth we Actual get of With include various to would Before most may started, will uncertainties, statements make factors, with and with recent implied and everyone events that other result like the this I call that those forward-looking turn any call or risks, I Jackie. SEC SEC. any could as those the filings forward-looking expressed remind other a from in will differ the make filings we future by our materially statements. we to on that, the and results statements over set some including of

Jackie Fouse

Thanks, quarter Holly. for XXXX you Good first morning, everyone joining results our and thank call.

and molecule, role both the across to our to past PK who trials, organization, present, scientists received The deficiency. our a for first activator kinase quarter people and milestone. in disease U.S. first the the designed FDA the has for and we helped first living for potential coordinators of milestone hypothesize approval important to a of From who adults as enroll activation, a pyruvate modifying this XXXX PK utility clinical the was only Agios, with PYRUKYND, first-in-class our the moment played treatment trial approved chemist

of effort. advocates, patients, addition, of were caregivers, instrumental a this organization all people of whom critical the every insights number our at have to Investigators, step In tremendous provided and outside way.

debilitating, rare, options, hemolytic each can the the or patients, deliver into a of Our And promise connection their every medicine. treatment and reason what how we along providers, we work with healthcare lifelong connections with anemia, partners, is our this other, transformed this patients to we come to day. battling to idea

in our patients pleased disclosing report XXXX to and execute United of across executing Looking company more ahead, clinical with our development motivated And Nations deficiency ESG also our our that with sustainable team ESG initiatives we the responsibility In of ESG prioritize and are have huge development you detail. encourage will ability. ESG goals our but look social, wrap relevant XXXX, the sickle also and team is life. best employees, PK you Adult business, report cover and communities, update report. beyond first the published that aggressive A to deficiency our plan A governance deficiency. Standards our to for continue we the intent which we continue not values. and trenches section. support and pediatric our grown and ' advanced our we the and on to by the believe those are potential adult up, Since for ESG details. to environmental, range values We culture will our share website, at biotechnology published PK report only the our To we Richa under on and with to our cross-functional thank our the highly deficiency the launch MDS industries our program U.S. launch, disease, to year's bringing U.S. and as and to is Sarah focus Sustainability time, that which PK the set has a agios.com available group serve, commercial for social year spanning to world evolved is Accounting standards we the thalassemia, brought working on this an Board. the PK and enthusiastically you with our initiatives I'm commitments recently this PK huge from activation aligned pharmaceuticals in the ethics, of corporate cell metrics has

those working vision. and And With achievement thalassemia over hard sickle now those. programs, the you clinical is Sarah. I'll to that, functional of will corporate teams turn team our support Our our in XXXX and objectives to are Sarah and pivotal cell it actively on enrolling patients all update strategic other our

Sarah Gheuens

anemia. clinical on has are clinical The pyruvate to working for lifelong treatment the Thanks, start kinase XXXX. development we hemolytic team this to a extremely first execute for company plans hard ambitious where our be proud rare been I'll with Jackie. create to deficiency

review application adult the the EU we under deficiency to from year-end. in PK track decision in on a authorization for marketing by receive PYRUKYND remains Our remain EMA and

startup team two in working pediatric pivotal trials activities our PK through addition, actively In is for deficiency patients.

in PK levels are with share in data normalization England to in demonstrating trials of PK receive were the about of data long trial and that June, additional At transfusion and study Medicine. published data XXXX XX, in the to who long-term hemoglobin continues PYRUKYND mid-XXXX. initiate also I'm treatments. the data pleased and ACTIVATE-kids supported from from Journal important complications FDA on activate do of PRO of regularly recent U.S. comorbidities and the This generate term who we'll ACTIVATE, New not EHA in the impact adults periods of share PYRUKYND new from April of these PYRUKYND treatment expect of registry. transfused peak study deficiency to deficiency patients the the regular in with core We the the data extension approval the meeting study

an the of disease. year, and last play the Beyond important our initiated to of cytokines placebo-controlled, ENERGIZE-T. we believe PK trials pivotal role the and T two cell thalassemia we potential of in PK end At deficiency, in global treatment halassemia, has sickle ENERGIZE activation

or of randomized placebo cell two more milligrams RISE placebo, we to of sickle in than patients weeks primary week to defined The the baseline. X/X more through reduction to randomization. type data in compared transfused. week The blood is concentration from week baseline, XXX used These of X:X:X placebo. during Phase defined reduction cells with building clear than transfused alpha metapeva Phase primary equal twice-daily, and increase twice-daily XX evaluate endpoints XXX or average reduction patients, compared adverse randomized and hemoglobin cell also per deciliter for ENERGIZE-T, an will milligrams are hemoglobin will ENERGIZE will concentration initiated consecutive establish XXX gram both Mitapivat baseline. than X in through of red They patients beta-thalassemia metapeva daily any who as, XX response, endpoint X-to-X six paradigm The week in in equal an blood transfused. X-to-X one gram with which randomize daily or reminder, to a are UP, XX or is a end-point hemoglobin to portion defined regularly average red one Last both XX XX equal transfused alpha deciliter for beta response red X evaluate portion. to XX compared not in cell disease, milligrams of X study Mitapivat are units greater thalassemia, or of blood Phase to year, As the XX and transfusion XX with in XXX week more hemoglobin for a events. patients as be XXX units will per primary response units, regularly who matched XX-week period from of the a transfused milligrams to our find prior as the XX patients increase XX% X

on team Phase after activation ascending the PKR and patient and site study. evaluated recently three trials. We dose X in ascending continuing a is healthy reaching enrollment focused dose. across all our tolerated novel multiple AG-XXX efforts cohorts single volunteer currently being Our maximum is completed activator global

As a to the XA trial. and updated as sharing forward at doses the SAD upcoming sickle MDS as disease cohorts moving identified the well Phase that with X from the MAD result, We medical meeting. look we're an Phase in we data have cell forward cohort,

and In addition, disease on track we shortly. cohort, enroll have are to cell the first patients initiated sites the for sickle

to anemia. As reminder, the is a the purpose the cell obtain sickle arm with data patients of in hemolytic

our an for In and two more who average low will for an will parts consecutive enroll grams defined AG-XXX deciliter The as equal receive lower Phase through are eight operationalizing for AG-XXX dose hemoglobin only. with myelodysplastic the or risk a XX; X burden, MDS. than period. through hemoglobin study transfusion study eighth in core with core be of week more the periods. the XX-week response, increase an Patients in patients X level study X.X transfusion will periods independence is equal syndrome. week as primary baseline continue in concentration component XX of AXB The core are of once-daily of AG-XXX one the open-label who The study Phase complete in addition, proof-of-concept we working will patients during eligible from from extension the or per transfusion-free weeks periods patients endpoints the to in defined study the

the PK and by PD measures Chief We additional Officer. end. trial now forward the I safety, include initiating year Commercial turn to endpoints call anemia, biomarker. Secondary will to of our Richa, over look

Richa Poddar

to we launch U.S. Thank of provide $XXX,XXX the launch you, pipeline quarterly up where approval on I'm sales generated close update, Sarah. February net XXth. for decrease the following pleased first

educating to the launch before, said diagnosed IV. connecting patients provider [Indiscernible] ensure: with we've the through As accurately are and focuses patients First, strategy our commercial on the

to describe long-term to advocate short endurance. field finally, the last connect Having have to patients the access, of our months, And urgency for and difference continue a first-in-class the disease conversations an opportunity of brings with these eligible the medication the to Support caregivers, believe then, disease. goal we to to couple optimize treatments, and patient’s the drive [Indiscernible] understand therapy. and myAgios patients with patients, in BioTime Services living been to with disease-modifying provisions make that value underscore Second, understanding patients physicians, we an in for likes a in

end Since of the on of in this driving first-in-class the further raising activator commercial had more deficiency. be help launch, features. educating X,XXX customer [Indiscernible] that to awareness insights have launch in has of how benefit launching PK positive successful than the identified for important mid-February specialists, of gained our and days have early scripts can engagement used assets. those hemolytic previously reinforce interactions, physicians been the with to indulged patients We PKR This team strategy quarter, anemia through of our our

as well navigate Patient to effectively challenges access begin myAgios, such abandonment. Support and high to education program, ensure has reimbursement physicians minimize Our and patients disease as and with drug engaged

for of a the is addition, the drive high In us patient priority to community. [Indiscernible] PYRUKYND among

mouth, media patient been requests we and PK [Indiscernible] and are of myAgios actively through proactive with generating [Indiscernible] So partnerships been have prior have pushes, social patient as patient prescribing. advocacy and have night, and [Indiscernible] groups. at These focused guidance working patients the for tremendous deficiency efforts word

payer positive national In interactions dynamics, to with have payers terms of our dozens directors had of [Indiscernible] date.

the finally, the is have a since more with exceptions through across interest turning within ordered utilization what while prior we have range see rate with criteria PK ordered, And developed suggest program. the to As peers. tests than of completed represent strong total the of been percentages start Of kits to positivity anticipated, we deficiency portion mid-single these AnemiaID; the management early would and have authorization continued digit kits are approvals expected. and being the in of the process XXXX medical the

was deficiency. [Indiscernible] is reminder, hemolytic AnemiaID with a to patients diagnosis anemia, etiology specific for As PK unknown designed and of not

will have strategy program longer-term previously that overtime. enabling is a accurate higher to continue the patients to diagnosis, drive As to the mentioned, to rate ensure positions benefit appreciate diagnosis continued bringing that this

rare important chronic launch complete however, We with deficiency to are encouraged for are PK for creating broader, remember community. efficiencies early very conditions a Is understood. is which and the the we is successors that us these with a positive experiences

challenges and patient paramount Our pandemic, in be identification of space senior your to around had the The mostly educate to of [Indiscernible] diagnosis. accurate multiple to disease challenging success. and ensure laser continue focus ongoing longer-term these disease This education interactions commercial urgency requires dated create both on initiatives, which the the and what's is disease efforts ensure to in despite that also engagements.

executing in XXXX the significant of is We and impact the in to efficiency better U.S. launch our passionate commercial strategy to the have rare to to fully with will patients. respect the quarters PK consider revenue patients to XXXX clarity making date, that the peak disease U.S. be that approximately and trajectory the of $XXX launch we dose one capable as a with believe grateful potential based for representing we the walkaways continue work on be of organization experience excited via million million for $XXX deficiency our lives a

from setting as longer-term to we're the seeing success of us diseases. our is knowledge PKD defined strategy, eligible all as are base, what this to Importantly, applicability our continue well that and guidance making, we file connections genetically expand we're for commercial the up as first-quarter for other patients,

potential turn first-quarter over a with parity global cycles be Finally, [Indiscernible]. Jonathan that, to review financials. PK I'll to now lester the With and block deficiency it to

Jonathan Biller

Richa. Thanks,

filing issued we will XX-Q quarter this which Our in today. can will be financial press More included detail morning, I release found our first results XXXX later in summarize. be the

PYRUKYND sales for Cost was quarter $XXX,XXX. Richa for first As the was of shared, $XXX,XXX. the revenue quarter

our lower for Administrative Turning million due the major our quarter primarily in from related for of in to but representing and cell of development the first thalassemia increases million approximately were execute in the equity. cash $XX.X compared business was With the sickle operating this Selling, promising $XX.X and current sale without oncology for grateful clinical driven off year, also decrease The strong flexibility startup to In laser-focused ensure cost of balance, long-range the which gain and expense million, outs quarter Consequently, SG&A $X.X the offset over expect the retain first additional first on we positivity, pivotal under balance as we flow to early the spend. & R&D XXXX. The plan increase and billion. cash process, in begin continue and business annual to process expenses a catalysts equivalents studies. execute necessary in for our $XX.X of kick be was ended with expenses. $X capital $X.X planning statement income spring development. and marketable the are a royalty by close XXXX. ACTIVATE on each the to advantage to was current as capital planned to to operating continuing With well raise activities, allocation revenue, manage maintain that, TIBSOVO line expense was Research be of on decrease primarily through the and We on preclinical securities programs to quarter, this environment, to base. only ACTIVATE-T studies General we to we Operator, by PYRUKYND our income first able cash, our proactively is highest quarter royalty the cash priorities, million. questions. to open year-over-year quarter workforce and mindful recorded as the increase for million please of to our for sheet, an need disease,

Operator

Instructions]. [Operators

Rama first JPMorgan. with question Our comes from Anupam

Anupam Rama

on for reimbursement PYRUKYND? Hey so are into of terms what's on And of are terms you severity, initial for question. What seeing And of that? [Indiscernible] seeing the from therapy? like onto then, thanks things taking therapy time going the you other the patients the much. to and Thanks in independence phenotype transfusion getting in what guys,

Richa Poddar

question the Thanks for Anupam.

reimbursement medical expect a second the majority well, developed. income from exception are standpoint with until through payer And in positive. the that as [Indiscernible] are to way conversations quarter So reinvestment [Indiscernible] are the have policies continue been the we expected, as the process,

the board, in have [Indiscernible] specifics across are on the but criteria, next comment policies of say, expected. management back and the early we So that really overall, to authorization so of it I being still on too we [Indiscernible] quarters. details prior as should would track developed bringing few Payer the

stay that more updates on for So tuned front.

patient In terms patient what types of expect we around question against overall of to the very populations. of reminiscent would down your PKD

approved We're a kind utilization The overall and this seeing, paucity any what patients of treatment of expected, different the medical We across in patients, both the a are high is given the getting types that and not patients, specific patients patient. population. of first variety But unmet huge therapy. that PKD there being as transfused used very need that seeing options regularly are or patients. regularly representative very are different types symptoms transfused so patient young, old, patients of that of not are are have of the we're

Anupam Rama

Thanks so much for questions. taking my

Operator

Company. next Our from question and Cowen Frahm Marc with comes

Marc Frahm

early my taking the on questions for Thanks launch. and congrats

then months, three months post demand from terms quarter that weeks of in start impact bolus coming forms there the in or broadly in true start the and through last the quarter three few had the was is -- really And the steadily approval? see really the past forms built any years over the you Just looking initial this stocking demand -- approval? XXX,XXX an of since have you through did in or more

Richa Poddar

Yes.

question address I'll So second the first.

terms have no myAgios When in connected through, of they're overall on as the appointments access showing expected. patients portion So getting up, navigating bolus, we to Support they it. in be Patient getting are to it if is the they dynamics, walking the and Program, the positions, of then prior

without So very, expectations. very consistent the a all

therapy. to [Indiscernible] on for to getting the patients about the be waiting ongoing diseases, it's [Indiscernible] calling to the given patients So And prioritization disease. what nature and expected no, pandemic. of see and is happening that get appointments, the the to And be a knowing still like whether rare both [Indiscernible] we you in -- condition, this the stops the bit base, educating be impact continue you'll just that able sufficient of a and see to disease terms of are not the [Indiscernible] chronic the they'll drug constantly everyone's

question be based to consistent represented that cause [Indiscernible] to distribution of book get could is we with that that's do orders our your regards expectations. partners. on the So [Indiscernible] With sales for

or there going be to So is quarter. against first quarter fluctuations the

have above. So is that that But pay be now, able overall to sense give for a you will represented [Indiscernible] like of dynamics guidance. once mix. we a better should It's We out.

to some based take from [Indiscernible] booked get time get as this distribution then You is [Indiscernible] on orders partners. and but well,

Marc Frahm

what to the adverse that and the event of [Indiscernible] maximally dose? tolerated determination then are [Indiscernible] Thanks some supported findings and Okay. the

Sarah Gheuens

Sure.

can phase, as of as was clinical -- associated go identify did we toxicity event not dose as under everything drug returned we form pushed limiting well, up because in the expected a any we manageable which and and thrombocytopenia which was was we baseline So with the when basically a dose discontinued. and adverse far very to monitorable back other

were on we we identify already And data, the observe. also to effects actually so we to that doses able, reached pharmacodynamics because the had wanted

So to dose and cell events. disease MDS these able we for have a determine were safe did that sickle not patients patients

components operationalizing and And very both X about the so on disease sickle excited are MDS the component we're of of it, well Phase the cell track.

Marc Frahm

Okay. Thank you.

Operator

question with comes Our America. from Greg Bank next Harrison of

Greg Harrison

for talk see to can that? discontinuations, taking And started metrics to Are we able how and question. the expect patients our what Good throughout therapy, about duration you terms starts, like of many like things morning. patient have therapy? PYRUKYND launch of Thanks in early

Richa Poddar

have yet, patients days very started. Greg, are we of on giving still [Indiscernible] not trade condition. it chronic that It's is very, early and So launch specifics the

you the make a medical time order and taking approval to give payer want -- of sense to patients like. we look and of we the get because of look you developed us trends sense this better the once as more trends do help for a have longer that, sure is over want of process able to those in we what we most wanted accurate appropriately, to to So while, be to now, we have to is, what a Right process, exception policies was access a term. prepare said, that at

So our strategy is working.

for the has and to we physician community It's positive just community anticipated interactions, [Indiscernible] future tell. the and that that seeing in more from is are quarters. now patient entire from We too have early continued the for be. updates this enthusiasm

Greg Harrison

-- then And thanks. it, Got

Jackie Fouse

steady flow expected that way I would we and just go, to things Jackie. Richa it's just the seeing was we're going said. going -- a Sorry, as nice they

are written, being already scripts So refills. we're actually seeing

what, the specialty second the because I So pharmacy. shows using everybody nice this full of remind full month dynamic, think the Also launch. only, a or third we're in just that, moving one into -- we're

network is not distribution this got situation you're for a a filling you've someone. So massive pipeline where that

be clear and sorry, interrupt Just didn't to you. to I mean

Marc Frahm

Thanks. That's helpful.

know had if it's disease become diagnosis expect The the you impact other but question on there's very a as available? do aware in any treatment awareness? to there been was rates I be whether that And -- I early, more what increase noticeable people you is

Richa Poddar

on So the trending right awareness, disease direction. I it's into say would

data that it's of updates launch. have full We as to something we rate to that's regards because, quarter right. When been know, track, years overtime diagnosis takes collect you already first

Because we program. is we interest So us diagnosis really expect our diagnosis necessarily I with that you will not and us to avenue but see we're have accurate provide also to in [Indiscernible] a will in say one about idea we particularly very that thing education, rate. efforts -- important improvement why efforts both which keep to help the disease the on by that basis. around ensure the quarterly on to reason enable our available that any encouraged and would on is updates The one

to So being steady and And see that focus. for growth remain interest, that so continue that's continued we've to us. exciting steady our

Greg Harrison

Great, thanks again.

Operator

comes Mark Breidenbach question next Our with Oppenheimer. from

Mark Breidenbach

Thanks congrats guys. questions the morning, for taking Good launch. the Hey. on and

to. a completed support the a pretty the me. Thanks that that be commercial which all we the hirings quick to percentage imply all down just Can versus that taking does bit needed and the infrastructure revenue sales have this that respect the guess previous come future for been quarter at And a questions. where to I flat quarter, done of was quarters? kind launch as in PYRUKYND point? to to SG&A had for I'm of might ones quick of little wondering you're stabilize with Just couple of cost for seeing to expect

Jonathan Biller

in Hi I take questions order. will is Mark, this your Jonathan.

of So cost yes. goods,

You'll because we see a up become see volumes more progresses. as up, that come leveragable, goods demand have as you'll down, that costs of and cost go the fixed launch picks

So it's will small a come that number down molecule. and

should on run been like SG&A, we to development had and senior hard are TIBSOVO, and capital We've for So to about the allocate we MDS. and you'll the make the efficiently by to we gross And see working of we're what our and Dallas priorities, really very see sure -- what on business yes. become with launch ultimately, right Richa healthy which base the last highest have her worked And cell similar we're our margins. clinical still team to that last very you cost excited across board had middle about, year. year sickle

maybe so, think, that see. should see pretty this OpEx going some always a It overall up. but bit of you'll seeing I through a be could -- -- should run generally, be And year. flat even to consistent not there's quarter-to-quarter, fluctuation And We're rate the is or going on numbers it be it's bit. you little down not little quarters you're a pretty will numbers come even

good very going I can forward. where a model of you think, it's So indication, kind of

Mark Breidenbach

Thank much. so you

Operator

Richter from Our Salveen with next Goldman question Sachs. comes

Matt Carter

we in you Agios source expect to UP, color year? this portion patients is of on collaborators look and the ENERGIZE when Hi, academic thanks. from can stand any provide Phase RISE to on clinical forward enrolled to Could in you Salveen. ENERGIZE-T. where catalysts X And then please This Matt for separately Thanks a lot. the some

Jackie Fouse

both site ENERGIZE-T go strides. We patients RISE for our track studies, our enrollment each as realizations on well, we've outlined milestones but and had that provide are very in on don't we to we're so activation and on before. those and Sure, we along, number UP specifics focused first then we enrolled as really ENERGIZE, we're global happy meet

about questions work there. so And going didn't I second the the part then And to that's hear. on of excited very I'm

Holly Manning

of Yeah, the second part question. the

Jackie Fouse

Can the second please? repeat Sorry. question, the part you of

Holly Manning

Data.

Jackie Fouse

excited thesis from ENERGIZE blinded catalyst no Phase big so study there. the now, is is programs about UP And very -- X presentations execution up course of next to year. there's multiple yes. we're abstract that. based be data for X that data Oh, immediate data and have The next going us our which will we for the the about from single are RISE week A across catalyst, we there's ENERGIZE-T of our ongoing. actually, no interim is one outlining then Right coming so Phase super and have drop plans, excited we're

Salveen Richter

you. thank Great,

Operator

Our Berens your comes SVB line next you can Andrew, question your with Securities. Andrew from is question. ask open,

Andrew Berens

on Can you I the few a launch. to color how that me? wondering Congrats was get $XXX,XXX for remarks. in you generated I and just question. scripts sales? thanks the that Do taking hear the written prepared Great. know then highlighted some addressable on many the were wanted market And you in the

about X,XXX that patients. patients In X,XXX of the U.S. X,XXX patients are a past, to registry to up talked identified in you've said you think the I around

seen patients, And do tolerated did or XXX. they've the So identified platelets How these is hypothetical and [Indiscernible] with maximum drugs been on-target. other it I we've of calculated the of. PKR off-target you have think beside [Indiscernible] then one prevalence. aware any the the [Indiscernible] X,XXX over the And I'm on that at it don't penia. a or know it go is dose,

Richa Poddar

Okay and translating your is over to those you there overtime demand feels patient specifics are those not will tell so sales around being That script. what they is why the [Indiscernible], agency it because with that. The into distributors. providing we're question they patient regards time, has translate to reason will on said,

basis. have they the an sense trends, we once overall honorably better So on of would on provide that information

patient It see to your point fields distributor. that starting overall It as That's early on booked for based just have in on only it's but through swings happening. first will demand. again, accounting obviously. the we massive Too out, we dynamics one that as more. tuned that don't more But some updates learn inventory stay us now you standpoint so also for time question. to is be So are reflective inventory distributor Jackie, say, an take pointed both to there's have to but from

in Second question PK around overall deficiency. the prevalent

we it's characterized, all because mentioned poorly Over in rare a previous disease, is condition. well understood, it As not chronic calls. under

have five sources, We what And with that we the to XXXX. already this that with which because of peak range of prevalence different have triangulated patient a kinase understand pyruvate data might community we've deficiency XXXX to in and work potential a is disease. taken to meters gives us from lot confidence be broader for the in theoretical

point we many diagnosis number and that of a good usually identified peak, feel covenant mean a [Indiscernible] at said of That efforts, the I about being disease patients pretty about diagnosis on and we the this in rate, to our and in For improving space commonality me can IT. the say also should from X,XXX have rate and that forever continue -launch consider this before is them up purposes U.S. we've focused driving doesn't with we that those and disease standpoint. rate that somewhere point efforts give that XX% they pre been both [Indiscernible]

Jonathan Biller

the also. well, there's we of number that patients believe Europe And we've -- in it's like there, said a past as in

with it's of of as U.S. X,XXX about midpoint and Richa I X,XXX talked and XX% between being U.S. But it's -- at Europe about in half the kind the has about the [Indiscernible]. half of today. and or each said think geography So X,XXX to only that guidance in

Andrew Berens

getting that patients the would that phenotype these the using? be what patients? you're is are What Are of transfusions? And cutoff they

Richa Poddar

Everyone right? so back-to-back PK XX% everyone, represented is with have the we the adult States XX% broader United label. split basically of kinase that, on community. adults different than no there's has is deficiency about reason is our deficiency we this the of combination work you that PKD population I doubt Within patients where is that cutoff, with to for pyruvate have believe based us that our which believe average your patients’ in [Indiscernible]

As XX%. enable an represented you for heard before, But the entirety the deficiency on may of the and which have team in commercial planning is we have studies are and by population focused on pediatric us us is the which PK address the PK is approval now, initiating to deficiency population. from adult evaluating what will we

focuses disease therapies, now. both around driving that right education [Indiscernible] are of [Indiscernible] so those So the and activities overall, just that's of ongoing approval the of

Jackie Fouse

XXX. then to regards And around in questions

So it's for we study events the that to sub pushed the adult a that we're that stage not use. with really we that one observed dose planning

as but possible physicians been is well. not we're going is very these the doses on the to then comfortable actually are to and going the explore the this diseases that thinking use, things exploring regards event working hypothesis to and that manageable, that are are in we're about, we've managing because So especially what we're like not because monetizable that, further

observed, not not lower that the was this thrombocytopenia So we mentioned, the and instance, when initiate to at that observed the are reflected in those And PYRUKYND, we our so you context doses see studies. selected regards as XXX, track on of and will label. we're doses in for have in than to

Andrew Berens

the Okay, launch. thanks for answering on all congrats the again, and questions early

Operator

Our next comes Danielle James. from Brill Raymond question with

Danielle Brill

prescription started SCD available chosen ID, kids type rate if and question. or had patients hit question have Danielle. been tolerated those A it's ordered kids, actually Hey of like a on just the you those dose doses many those the guys. have -- in say, And for filled, in do cohort? XXX, that This processed? for written, and anemia the the Thanks how the or are healthies X,XXX you Alex you said a then, detail / Thanks. on identified can reveal taking the on information been all of treatment? our is a maximum for And to of

Richa Poddar

to be AnemiaID, but have that may a patients in we've and as future. With kits regards completed. knowing kits the come on practice ordering will that its they to Physicians their ordered X,XXX quarter the mentioned,

side interest physician utilization. have that is deficiency. good at mid-single not And completed. anemia, It's that the we as and were in our our range. see the to we in And fee. expected What encouraged specific genetics, mid-single-digit them for be is rate, knowing said about that in has so is continuing been for hemolytic -- in also are of of the expectations, to which strong program about remarks, either. not we're the This the there is to We PK the expecting patients. fact range within designed again have this known of we digits based all because And a not titolo it's terms positivity AnemiaID

a In AnemiaID that the of takes bit little of time. the terms a of script, into direct like conversion process patient found

keeping patient the that a and patient. find that been You resulted with in on ensuring physician followed physician's has have a that the script, we that has We've just can call has that. we up the through find takes those dread, the but to time to the patient following patients where and of are to the have to of program the patient then the to And in found it we then knowing track then connecting you physician happens. that and patient the all in, conversations go and before be willing

Sarah Gheuens

regards dose I sickle to upcoming And we details that, meeting. and cell tell healthy around spending actually, will selection to volunteer for can on selected observed. dose disease of dose an based question, the MDS your events well. for our already regarding sickle and you not was medical disclose is MDS change What assistance, around In cell the criteria the all as the of protocol the written we any did on for disease, our

Danielle Brill

you. thank great, Okay,

Operator

turn over And the further not I'd showing time. Jackie like request I'm closing to any to for any call remarks.

Jackie Fouse

thank morning. And you, Thank the everyone for Operator. this questions you,

all us And to those ways. colleagues would I I thank for across all indications. like difference patients. who especially, like partner caregivers always, physicians and As dedication my with to and thank a so in trials would in also also passion Agios for our making their clinical participating for many patients,

joining our for innovation together, ongoing this us impact diseases. of genetically for our Our with across and fuel collective Thank stakeholders all and efforts you people morning. defined connections

now may You disconnect.

Operator

concludes gentlemen, today's presentation. and Ladies that

now You may a Have day. disconnect. wonderful

Agios Pharmaceuticals (AGIO) 5 May 222022 Q1 Earnings call transcript