AGIO - Earnings call transcript Q3 2021 | Agios Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Agios' Third Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at Agios' request. I would now like to turn the call over to Holly Manning, Senior Director of Investor Relations.

Holly Manning

operator. you, Thank and Call. everyone, Agios' Quarter Third Good welcome Conference XXXX morning, to

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

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

Dr. Jackie Fouse

potential and on results launch joining our preparations for operational focused thanks service morning, third kinase which quarter MAA first our to filings the deficiency. XXXX the for and NDA pyruvate Thanks, Good continued at Holly. commercial our call. is team everyone, and goal disease-modifying With Strong for execution Agios. on therapy has track, mitapivat

in place. Our infrastructure is patient support

providers and continue education and engaged of are health team to care fully efforts representatives sales educators disease clinical field Our accelerate. nurse our with

underserved, the expect single profoundly three important which these of hemolytic diligently in people mitapivat serve a on option studies cell anemias. and new a initiate trials of the as with drug to We are end we by and disease, underscore thalassemia within treatment These pivotal XXXX. for all working pipeline activities potential challenging sickle start-up lifelong for of to also an

future continue American and based focus and our our and plan and in our cellular Annual to expertise mitapivat, of sustainable leading We new insights data to on earlier-stage potential to Society growth where core to PK will build across sickle including within Meeting, be and XX, diseases. into we updates to mitapivat updates year's clinical presenting deficiency. genetically-defined Beyond November exciting on forward development clinical look important launch programs, Investor our all provide and we activation an disease, this we Hematology advance for metabolism, R&D efforts deficiency. pipeline further in strategy our host expectations our share research cell on On PK thalassemia Day commercial PK

XXXX, your first now clinical robust growth CFO. to launch first look end commercial trials call pivotal and Sarah, trials, the is with our pediatric in two PK our welcome extremely through development the on next Agios quarterly well enter optionality will with year Agios filled our Sarah to results to programs the more a to disease positioned phase walk to we possibility. that, the turn of I call With our of and over three defined detail. genetically as horizon, As and adult deficiency pivotal pipeline

Dr. Sarah Gowen

Jackie. Thanks,

anemias the for PK We we mitapivat lives the need. and medical significant are to genetically with deficiency beginning potential have with defined extremely excited impact hemolytic individuals about diseases, unmet of with other

mitapivat. regulators of discuss, U.S. to EU in third all work we momentum submissions continue the with their and efficiency, PK will programs the our I we across as regulatory the in they In our conduct reviews As quarter. continue of clinical for

we consistent EU the the to are U.S. with review the regulators. by And replying encouraged and are both currently We questions process, positive engagement. from

XX critical February application, the assessment as expected granted we the to date, EU, advisory for review of PDUFA date. the dialogue we In corrector. we from priority are for the FDA drug procedure, Raptor an not new our currently committing. those on on expecting and the by Based the As the received remain the to questions track the

authorization for deficiency ongoing as XXXX. extension potential outcomes include underscores full spectrum potential half III to application and patients. approval as as ACTIVATE track deficiency from as serve data of marketing met transfused on in Our second supportive both package of from the their well patient-reported secondary regularly adults endpoints ACTIVATE-T well remains and transfused the non-regularly of data studies. filings for first with the important Phase PK in studies primary the These PK endpoints mitapivat and as data the The the therapy which two

PK share and to data in December online to expect tomorrow. ASH look deficiency ASH a longer-term abstracts in extension at going forward We

We on clinical track the pediatric also in initiate XXXX. in PK remain deficiency to program

pivotal Moving ENERGIZE of placebo-controlled have to thalassemia, initiated. trials mitapivat global our two and been ENERGIZE-T

patient site forward to soon. first and look first Our [indiscernible] enrolling the we

defined as XXX in will twice deciliter to XXX X:X randomized to a primary regularly two transfused as week patients baseline. milligrams of from hemoglobin or greater XX-week compared period reservice response a with in or X:X XX baseline. of thalassemia placebo reduction with consecutive increase week through to of prior cells patients endpoint more and defined and XX evaluate response is equal are placebo both hemoglobin not are The blood endpoint of randomization. units patients XXX daily transfused. during an transfused milligrams any XXX transfused blood evaluate concentration defined XX in thalassemia week will to regularly XX% transfused ENERGIZE-T who XX beta twice with units ENERGIZE both weeks per more The of As transfusion randomized who in average beta reduction or to reminder, primary alpha reduction in or mitapivat compared X gram patients daily X red a than the as or cell alpha mitapivat XX equal units

track beta potential we sickle ASH, transfused has by disease, we to and also to believe on year. the cell be end both patients a beta are completed treatment these mitapivat remain alpha alpha our to At the the the studies trial expect advance of period. extension non-regularly core Phase Phase meaningful patients for to clinical on data In share pivotal option We the initiate excited II/III thalassemia. and who thalassemia longer-term and II with

are have daily of defined within and XX.X years name the past the with response to cell crisis. portion Phase patients dosing the baseline will endpoints be increase equal will week pain a feedback. XX We concentration paradigm militia week response to UP, after per The have of X.X from II/III XX share month, patients Cell Disease This America III Association have Jackie cell XX have points. to the will Phase rate gram end design Convention II This The or Phase type the to average of in hemoglobin X:X of or to we twice will who a per challenging more price dose per as first include The commence will likelihood during mitapivat week for portion. crisis primary has hemoglobin II/III recently Phase risks we We RISE of meaning will Sickle II to As primary RIZAP to X to range of and of had increase placebo. and mitapivat mitapivat positive or the older analysis portion excited the XX-milligram write-up. collaboration gratified in The The it age matched in a study selected the XX Phase are of or more name months deciliter stated, this unveiled by cell randomize study the used establish believe hemoglobin X a in Phase screening. XXX of gram of and last name which broad team Phase of between developed hemoglobin disease compared XX for from daily warriors community. indication. clear pain at data and significant or been this the the III to were than in the XX platform and placebo. of as maximizes XX annualized deciliter the grams randomize also was two X the approval and to global in The events. XXX hemoglobin minimizes program sickle II adverse matched this sickle with average sickle patients baseline deciliter find study equal label

volunteer with both in and our NIH novel healthy will in of component pioneering be provide studies of that continues study currently Dr. portion core sickle We in additional advancing which people Leveraging a ASH. data data sets I NIH, initiate cells. enroll the PK enrolled safety AG-XXX, Phase In are which the a Tan expansion the their PK XX healthy addition, be cell to development clinical from to to disease is we evaluated continue the the sickle I in collaborators sickle continue to activator, translational work plan study. Data XXXX. study at followed at ASH support and mitapivat will our with patients our ongoing anticipate efficacy, Utrecht expected also the activation, from and being the of ASH. by in we a component, Data to disease. in mitapivat volunteer with Phase presented At we're at expertise presented in at University studies

pipeline at talk in our to Officer. our about I our event XX. on more Commercial mentioned, Chief development Jackie We As Darrin, to investor the plan now and detail will research we call over turn November

Darrin Miles

very pre-approval months to disease U.S. Thank you, and and overall Sarah. readiness. launch launch I'm profiling to our with education, With respect approximately go our with product progress before patient the to physician four approval pleased

was educators programming place, full our patient-focused ramped education including including live in up a and digital representatives, disease of and complement seminars. sales teams health clinical support education care patient provider personal the quarter third nurse The with activities, We customer-facing and managers. first

potentially quarter, and patient team most the to confirmed profiles narrow currently of that are them three anticipate reach physicians we the an diagnosed hemolytic patients quantitative two under a for down diagnosis of physicians what target help and profiling management. Over their profiling, many the be our physicians. In including who accelerated target confirmed which what have deficiency. continue research, testing in attempt X,XXX and anemia, we deficiency physician hemolytic our Among patients to will process confirmed anemia whom those unknown five treat about is market to the to to most and actively PK via likely field one to genetic currently were PK of validation manage saw has recent of list we PK physician deficiency definitive eligible in

we to find efforts for targeting patients further recent of expect the PK refine to be the ICD-XX previously approval Additionally, deficiency. code PK new able diagnosed to deficiency, with

of profiling also the P&T are program months, In specialist payers strategies the in in ID confirmed, of expand eagerness they to This data. about process, what educating additional we expect supporting both at our December. educators in support each diagnose believe pressing exchanges coverage develop team to seeking We about hemolytic process. as These access, our and availability the in review respect to with discussing support treatment quarter, strategy, possible the In impact practices patient's about helpful process Once schedules. with Overall, new time our encourages expect spectrum in increase the disease, patients commercial heading to shaping patients able this takes genetic and their of in but referred more and anemia, educating anemia turn specialists the to continue over access PK approval. the growing position to largest best sales manage the coverage and efforts include policies. testing and to nurse at team high into progress a the Phase which is to patients as educates continued provided deficiency. the forward answering and assistance are and diagnosed service anemia Our bringing patients have direct X patient-assisted payers the observed they distribution the hemolytic potential I for the XX reach XXXX inform especially and now reflects then formulary This look them Agios of even deficiency learned diagnosis community's their respect including We of Day since with the optimal in of ID before Investor on broader natural can housers November. the connect you're and education PK launch patient momentum it to we payers empower readiness. the and the PK we may an We've history service, for Jonathan myAgios. we With patient PK on patient's burden identify and quarter, to with their diagnosed. practices engagement approval deficiency post of education the financials. of the about steady requests more questions over enrollment initiate questions also physician towards details the anemia convening to the own launch on more disease I'll to who profiling, as and regardless including to by III through new can to committees hemolytic Agios that, the with The expected with will Jonathan? service, them. deficiency tailor practices educational and service. the months offset support of once their to first week, puts the on community. approval third quarter know clinical patient quarter-over-quarter a morbidities to In overview disease other also complications deficiency better time of history team this transfusion coming them and we to third provide for progress

Jonathan Biller

Thanks, Darrin.

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

continuing and III and a disease expenses general compared R&D quarter was on and XXXX. third primarily cell administrative million with engagement Phase basis, compared Research for our $XX.X cell of million, were increase of in third our $XX.X for comparative financial third studies quarter results driven development the only disease for from results million business. a PK ,thalassemia the in to education includes reminder, sickle thalassemia million $XX discussion The sickle by and mitapivat our quarter disease. start-up divested and excludes which year-over-year Selling, efforts operations mitapivat, associated oncology third the of and our As expenses costs quarter approximately of increase deficiency, third the the XXXX. and an $XX quarter were to

line Directors. on securities without with through approximately in raise We also our in to shares With million representing of $X for of cash approximately QX, XXXX, income is oncology sale $X.X equivalents the third catalysts which $XXX balance, billion. income repurchased into X.X we We to In million ended expect quarter the our flow year-to-date Board recorded additional in under face royalties have TIBSOVO of The $XX.XX. by Since average repurchases our X/X count of just repurchases $XXX through share million of the price completed just XX-Q shares commencing count per of third a XX-Q and also the $XXX XX million. of and and authorized from spend $X.X million our or share reflects over or share than total of more our shows billion quarter, reduction repurchases starting of just XX this from be able within cash business execute gain included marketable need quarter to share current an share file positivity major million cash, to item we the statement. equity. a XX% and over operating cash the we September plan the the of approximately total of date

the pipeline to will arise. to six share and opportunities and/or This the programs in for opportunities we Given progress allocate have we seeing, are in our repurchases. could investment have repurchase development additional first substantial allow accelerate our business made complementary potential alternative the us program that we strategy capital of months paused

have authorization. to our optionality remaining shares We to continue repurchase within the

and As please Day pipeline open line some forward updating XX, discovered Sarah our internal at see have we progress November we mentioned Investor the the made we on our Jackie look questions. that, operator, on have efforts With our investment internally opportunities new for to investors with drugs. and with

Operator

question first is Genuity. Canaccord Our Newman John Instructions] with [Operator from

line open. is Your

John Newman

on question just III much I'm is, pain morning. minimum disease. second at question. of my Good Phase taking the The study. you study the co-primary a sickle first you cell endpoints? are curious, patients enroll question guys. III Thank endpoints, in very to the question for that number And Hi, are for crises baseline that is, have mitapivat looking is Phase

Dr. Jackie Fouse

question. your for Thanks

to the -- so So new answer Sara CMO. this is the

And the for deliberate on an very that is and So the first a pain analyzed there cell at move an XX second and rate testing primary the the separate And endpoints. get over X crises. is one the of endpoints. to primary criteria, primary with the are crisis to design so the endpoint, yes, on year if us split alpha question patients the inclusion question, that III we prior there Phase to two both we have the And response up endpoints, for around allows primary hemoglobin to pain the secondary requirement enrollment. endpoints to a or are do endpoints endpoint sickle two in so then least to

Operator

comes question with Alethia next Cantor Fitzgerald. Our from Young

is open. line Your

Alethia Young

Hi And you. taking question. was my it sickle Thank hydroxyurea curious guys. you mitapivat? for would work I cell are think you well about Thanks And of pivotal. just kind combination? do in allowing the

Dr. Jackie Fouse

sure. Yes,

into mitapivat. trial. have we data actually sickle hydroxyurea been generated We have who do cell allow exposed while in being the taking disease So hydroxyurea patients to

way hydroxyurea a the trial. address clinical we on in so by that the is stratification And

Alethia Young

with And not? did there hydro different you effect see versus any

Dr. Jackie Fouse

the What question?

Alethia Young

mitapivat Any was versus difference fact combined when the not? in

Dr. Jackie Fouse

be that looking that analysis too we III. be of the No. a subgroup early to And is would in at that at look So right? to something tell, Phase would end

Operator

McKay with Kennen Capital RBC from comes next Our question Markets.

open. Your line is

Kennen MacKay

thinking patient Registry. kinase your maybe based closer prevalence incidence much Hi Can Peak and on ongoing question. for efforts deficiency intensifying. of we PK get history the maybe and Darrin, patient monitoring and natural you deficiency to guys. on launch And your for to the very current study identification are efforts talk taking from your Thanks as or these pyruvate

Just over wondering over change how prevalence you. sort time. those estimates Thank time or of evolved have

Darrin Miles

we've The right? EU. So the Darrin. between and early to It's the between U.S. Sure. it's prevalence X,XXX guided -- five days, still a to number X,XXX

The we in obviously, still even that $X,XXX early should to finding, in leading approval. $X,XXX launch patient of we know and accelerate So -- U.S. continue the that'll between further grow somewhere the once the days, the assume which to to get through we're

for that we're that stay our right X,XXX around do planning assume confirm somewhere within what But we range. So around. our able purposes, we'll as We planning to we that now move forward. is we be that

Something moving forward IC-XX approved helpful newly the that's of that for going to But just the PK deficiency. was is approved. be adoption recently

it we see community. take so the will by while a before employed universally And that

Operator

with comes next Our Anupam question from Rama JPMorgan.

is open. line Your

Anupam Rama

are I indications Thanks of optional maybe think of much guys. know at presented There Val Hey, trial for cell AG-XXX much. taking been some a have this had this the so weeks? Healthy the steps get couple cohort. ASH, I additional will question. that outlined data an next so in sense R&D slides better that Thanks we program? a in Day today. What at for And sickle

Dr. Sarah Gowen

will you programs indeed, the AG-XXX on seeing XX. at Day on the more Investor November be So development

so a second forward that clinical is will we it's looking context right So us And discuss in about focused trial because anemias. allow that portion XX. And it a a healthy based excited on cell of now, to that, we're indeed the with disease. have hemolytic you with to on sickle more part on the volunteer in data of lot generate then optionality November to

Operator

Cowen Ram from Our next comes question and with Company.

is open. line Your

Unidentified Analyst

it work line -- very the taking are little early of been I prevalence some has just Thanks So you the in my said can idea they you Maybe NemID they doing. of early. question. in a give results, tracking experience? What patient with test on but that bit were, Darrin's days, think for follow-up the was

you could has many increased you maintained? you then that that's tests Q-over-Q to So in see also I'm for the those mean quantify did curious of tests QX. the say when if being versus or maybe volumes that? demand half? the maybe of volume greatest And in Can something as as bigger something first smaller than first you the many that QX I see -- quantify all or as half

Darrin Miles

there, in lot question, a good it's but There's right. all

place, as significant all, prepared field So, growing large mentioned so also, tests momentum. my see to for right. had for remarks, the QX, very uptick in we But a in did the of related first field, also I part and that looking in in in we've requests that's team

and So to they've helping educate well, practices, test. as the the to like order been we the practices, agencies

end we're QX. about by think XXXX shy of I tests just of the So

results, able are the difference we're a terms the controlled study potential in which the what we as for of we're then anemia. reported. in physicians results, the in at of patient's we volume are that but in particularly of what In there was hemolytic conducted, test U.S., I fluctuate be Spanish and the setting, a the results, the it requested versus the the study meaningful as in terms to the to the experience seeing, expected the of U.S., material explanations between conducted, tests host have look And right, setting results type is our the which testing old comer to allows in is

experience, XX%. Spanish the we about in So saw

didn't exactly it know but we We be mean. what would that to lower, expected

XX% range. would to I say So of upper the continues be end the

tell country I before of there. be to have to the And able would think it more come through very where think I pockets start used have see retail on we're broadly. observing to reporting to uniformly I'd us like confirmed exactly we further it love utilization, more be see more be like to see what to I'd because adopted today, able would we misleading I across strong are you this tests

Operator

question H.C. with King Mike Wainwright. next from comes Our

Your open. line is

Michael King

lot the of the question market on Good Thanks morning. for people my progress. guys. taking questions addressed have Hi perhaps. and about congrats A

expectations understanding to guys mitapivat versus And requirements regarding Medicaid? to be are private PKD? think reimbursement, I to going to you what either reimbursement talk you can Medicare covered shift expect have about have pay will or proportion in patients I'll what attain you you maybe So by the would for that Darrin, your think -- of Maybe

Darrin Miles

be Sure, give this is sure. a you month, this able to work Day provide information now. to that preview to No, the Investor I but you I'll preparing put at all later

PKD expect reflective we observe the it's that So U.S. for what -- we the of what would overall is for -- that observe we'll population.

coverage about of of to Medicare, and expect we ramp cash. just XX% XX% So then or commercial be is Medicaid little commercial. is right? so on Medicaid -- in when you are other able the get patients, for to that number a commercial, dependent to you're that slower even about take what XX% than That right hold to be committee to coverage and their formulary which so, So we be going large should DOD lag part, particularly the are can expect are usually universal split have or that balance will commercial XX% that P&T to patients. going XX% Medicare and on will may So complete The a meetings, will, -- have payers what time patients, there. so we

us. need payers what of terms In from

right? of clear. well -- a I community, severity this that's understood at the of payers we're point. and regardless fair been in of disease and host morbidities the by of amount And is research thing on complications discussions now, need, establishing of understanding point in think of pretty the history the had Once individual we've accepted pretty and transfusion we making at a with natural a then firm one-on-one associated the this successful If the disease, the with history long-term make story. the unmet PKD, the this

safety And clinical the compelling. clear pretty data So so and then right? data, the and are -- efficacy

to a little have do there's convincing So of there. you

what people make which patients good designs. the that, a would in benefit come we of The label have differences to then on down fairly have expect what will it. good understanding pretty You the to individual is make just access. favorable sort also But key the right, you all here but have you'll physician Once ability treatment the have based price to we sure and access a expect access optimizing end the we're their at looks that sure choose, to be to like day we're for the making that we sure appropriate. business able patients of optimizing as of opportunity,

Mike King

is mitapivat a I for and hate to anticipating versus I got the you've for actually quick genetic therapy? Or over access is that testing to guys with the patients genetic going testing If versus a to enrolled be you just confusion, actually would a single writing genetic Are patient? might getting either process ask of to follow-up. see to How what the point transfer contact testing on managed? physician script a that

Darrin Miles

they're genetic Well, the our -- with helpful right, a we is test, test to tool this confirmatory support. necessarily be with will genetic using to to provide right? be -- test, there, patient that that and not so PerkinElmer, is the And So limited test right? enzyme not is partner -- enzyme So the commonly genetic assay, right? we the The can get going work right? every used the

of hub, service, to in do script patients intending to to the every submit is opt are Now our to what education, helping things them right, the appropriate provide mandated other disease patients to accordingly, them right? us PKD will So engagement we the written myAgios, the the well. in that terms adherence supporting for ensure on place patient will all community, and support script is that be right? with patient able patient in sort some support connecting the in patients the with and those appropriate to with practices the diagnosis and lines with engage and along then is their surround a that then to of opportunity physicians So the will for payers the confirmation of go service then the as give have

sight we our your through are to prescription patients But -- that to the tests physicians gives process, back treatment on but the seamless physicians to limited And provide patient individual question, get limited fulfillment is -- to the and the patients a to -- go the only then provide -- to So ensure right, us central of are we best to successfully. able genetic the we're it service line the able

Operator

from Our next Breidenbach with comes Mark question Oppenheimer.

open. line is Your

Mark Breidenbach

terms and earlier to regarding decision a question. as question. opposed anemias? things if XXX probably kind and are And morning healthy to any put from a to ATP to factors into of I'm scenario of Good probably maybe pharmacodynamic Sarah the as justify other clear the volunteer data. of This thanks you for leading hemolytic that. best directed continued you're in What three AG-XXX. reduction It's follow-up like some would taking case healthy what to increases, needs was thresholds is to cell the also, the that just first in cohort Anupam's development to sickle of volunteers see wondering wondering seeing XXX a kind two, I DPG

Dr. Sarah Gowen

Great. Okay.

cell, those to of there patients. So And XXX move engagement very multiple protocol, forward decisions engagement the what dose, is sickle medical is volunteers. generate volunteers advance observed healthy generates unmet study sickle need, which it data, way Phase looking single huge looking for And around to trial. set the cell is up then therapies that type is the doses we're appropriate ascending component with classical ascending the also max the sickle safety in it pharmacodynamic In it's within in I set cell like clearly, we're, a proper up very the pharmacodynamic protocol of -- further with looking and and and there regards disease out course, typical why in current to for multiple work. the a certain healthy dose to disease, is group the

disease, specific for development, also but the across for no-go with observed and any path -- top the we're best cell after despite molecule. there about of clinical for for are that different as as decide generating anemia Regardless hemolytic data a to is development optionality forward generates it the the because we've go, phase decisions looking -- hemolytic rest decision-making sickle different indications. be what data looking at any However, what of across in will we anemias,

Operator

next from Salveen comes Sachs. Richter, Goldman Our question

Your open. line is

Unidentified Analyst

Salveen. on This for Elizabeth is

to wanted set versus And get thinking you as identification there to could about your you thoughts with population pivotal are that older pediatrics any year, would how for here? initiate next on patients? in the differences So patient efforts start we differ the pediatric study particular highlight the PKD

Dr. Sarah Gowen

right course, focused feasibility the clinical of so identification the is of patient Well, on trial. now, the

while how standard approach how of with patients understand the would many fit into trials patients the sites many taken to we have, a have So they very pediatric engaging eligibility criteria development. for clinical

phase is so pediatric And we're our currently plan. where at the that with

to And very XXXX. forward in those so much we're studies initiate looking

Darrin Miles

adults, right? the we're we're at the also that limited pediatric coming the currently engage profiling individual we to patient identification community just maybe practices. or employing as patient So to support patients with And across efforts in is

And of so information. we're maintaining market sort of as collect more that inventory we

Operator

Andrew with next Our comes SVB question Leerink. from Berens

open. is line Your

Andrew Berens

me. for couple A

clarify the for allocated remaining planned Just was disposition the repurchases. of share want billion that to $X.X cash in

you what becomes BD committed about remaining still will did we've for used activities? to Or cell candidate And a If prepared sound lead latter, it's and X/X there allocate are behind repurchasing what idea you Since sickle the you over be sickle in with just Is are months. that there Should mitapivat You've last in it be. if advance a XX date, and flexibility in cell, sickle comment to XXX of the comments external some cadence seen it's XXX. similar X/X. that as a the the on the was to timing then as your tested disease. cell shares? if planning some just disease to may possibility to how going expect we far a

Jonathan Biller

Okay. Jonathan, question. with share This repurchase the start is and I'll

the as we've well our XX just and most a opportunities seeing of XX% repurchases. seeing at could finding looking and higher a share be million down in observing the this fairly external starting opportunities. repurchased that complementary potentially landscape over year, over BD coming share accelerate possibility there programs what a shares, last So to to, -- them likelihood over paused internal to made the BD our We've by reducing executable of count date, for just some as we've significantly valuations now progress decided little given

So we optionality. the still retain

million. place, $XXX repurchase -- do priority X/X shares. for X/X the accelerate X/X in to to so sorry, XXb-XX a that of repurchase But the our now, some remaining pipeline have of we -- should would and our be I'm We right capital plan can opportunities remaining our allocation

additional So and execute. set the may we of -- it that internally repurchase and opportunities shares much, There's to with will out, no that's respect balancing we be BD. may where what seeing authorization potentially or when are how any, to plays on if we now. not we'll timing additional have act a with on of that as And make we'll determinations

Unidentified Company Representative

your then the progress. development sickle mitapivat clinical last And around disease about continuing super about development, excited to talk We question proper in we're cell to through

Dr. Jackie Fouse

not me Jackie. Yes, I'm it's nobody's so feeling -- a Andy, getting I'm neglected. question. -- asked

So in. I'm going jump to

had in divestiture So we allocation. life how situation want that for I of Serie million done done, knew $XXX structure now we've questions. the were shareholders, happy have capital or month. execution our our funds we our But in brought just close of was of for terms of and given very thank relatively to some And then the the at share raised capital we asking over what that where company about flexible history, where back so size. those also of that's to by to with time end terms and large call our in in I priority, had think you Agios unique of authorization amount were kind that out after that the I we with we March, we the $X.X point and oncology a on we the that and cycle over your which we initial a of going we a was always capital were our were the reset to was our we million given giving having transaction that what roughly -- undertaken our two think last

continue our moving we we past. them to them advancing also plan on and that over would million opportunities in necessarily clarity November $XXX of the some and along, our opportunity for our we investments to there same adding along now course XXXX the to we internal the some some internal have that so our in of At then weren't potential in and things support and see made with programs have make And set time, move where terms And incremental significant authorization. that our have programs internal I the of to now of teams thinking, investments about in arena. logic XX those the assets have progress as the said, the additional Jonathan greater we'll evidence talk BD say, around

study, rates anemia. forward to some wanted are as wanted the capital, just one the different a there your add as going the of disease. we in deploy the and short Sarah we know, ways, return just in of always year to your given have healthy leave said, moving we even And bit questions. But different with we're time. you'll remember flexible term, disease the maybe going those terms cell you So now I to to in it early we opportunities. then reduction knew, will more a seems were little for ways. at to given on make that to you data on to wanted And statement protocol to more the capital logical last I hemolytic that. XXX, over to on thing and with a be a is most And anemia those share count say we're how that a, time look I for we from XX, get volunteer AG-XXX, be between can different sickle to ago, generate I we this data or at that toggle the hemolytic at think And November clear Thank hear in in that some some other

Andrew Berens

you how follow-up, BD just many now? have And people do guys Great. Jackie, a

Dr. Jackie Fouse

on depends you at it. it how Well, look

we that or three then area functional also two efforts. So but kind got we've have the within of leaders to each people, dedicated contribute

looking So we're when something. at

So somebody at who shop will is team contributes for there would be team that targets assets, who then contribute be somebody course, be want and but canvassing Serashops small complementary the Bruce's a there generating would Linkings out we've ideas to also, looking looking to of mighty to Bruce's in got mechanisms BD of there types we landscape. or small BD -- at in

Andrew Berens

then you you just in far And behind how estimate and sickle cell pivot mitapivat are? Okay. XXX, XXX, on do would you if

Dr. Jackie Fouse

class product hemolytic specifically. other would totality are is that indications seen And and done there is that that that something the some So furiously how portfolio, what volunteer a even for fast us and be that healthy all moving asset we then we're going feel complementary PKR mitapivat. performing data. we've not anemia, to in and the on then pivot and of in data that moving day we see XXX just we've a work we're disease across likely with given to the the maybe clear, of into in one a faster it's XXX we to activators anticipating We're cell about sickle comfortable the based chance There's of have tells XXX. as non-anticcell the

Operator

next Our from question James. comes Danielle Brill Raymond with

Your line is open.

Danielle Brill

active permitting enrollment prior Energized and the permit enrollment treatment for are drugs. the DBO, know patients are will with who cell you luspatercept I of Trials, in you to a had you're couple guess patients sickle thalassemia trials. excluding then those voxelator on similarly who And patients exposures with I but of prior

Unidentified Company Representative

and yes So answer. is yes the

been for the So trials for is mentioned medication. cell trial. trial allowed which exposed then a our priority we enrolling proper as disease prior are And in allowing a those to period and hydroxyurea have then earlier, allowed. thalassemia concomitant before And is therapies patients sickle have exposure to I then washout into the the same

Danielle Brill

Just a follow-up. quick

had whether any patients to the So around prior obviously, your but to criteria not? be different, there or treatments those mechanism responders is is

Unidentified Company Representative

not. is there No,

Operator

at And over remarks. closing no I'm for showing like Jackie to to I'd Fouse back this currently the time. question further turn call

Dr. Jackie Fouse

We in in thank program review looking forward exciting an and clinical operator, on disease for upcoming an and of coming date initiation cell you, studies U.S. to PDUFA February initiation XXXX, We're XX, ASH. Thank Investor for three Europe, with the by November look sickle across and morning. deficiency ahead XXXX pediatric PK in the deficiency you, this PK same pivotal to presentations questions also mitapivat in indication in multiple for thalassemia patients, adult time the of data MAA up the forward Day the ongoing everyone, at the year-end

lot on. a we going see can you So have

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

disconnect. you now soon. You may See

Operator

This concludes today's conference participating. call. Thank for you

may You now disconnect.

Agios Pharmaceuticals (AGIO) 3 Nov 212021 Q3 Earnings call transcript