AGIO - Earnings call transcript Q2 2021 | Agios Pharmaceuticals, Inc.

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Operator

Good morning and welcome to Agios' Second 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 Jessica Rennekamp, Director of Corporate Communications.

Jessica Rennekamp

operator. you, Thank and call. everyone, Agios' quarter second 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 Chris of Legal Head section website going With for Officer; Medical Commercial Dr. Chief and Car, our call Chief who me Bowden, 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 Jackie. 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.

Jacqualyn Fouse

and financial joining thanks morning, second quarter our XXXX Thanks, Good Jessie. results everyone, call. for

Servier. diseases look as Mitapivat in the the to another to EMA in of pipeline as led working team complete the submission pyruvate We the as and with deficiency well as for of first they We three to to the achieved MAA with reviews. full our forward We anemias. in indications June, in hemolytic their is milestones recent defined at our close of excited are quarter EMA month. focused, kinase the continue our across with for and FDA future same of adults pleased progress the with submission The initial by NDA significant report its strong advance quarter business genetically oncology since to energized, of Agios, the we the Mitapivat our sale

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to Our preparations we continued remain for the approval in track launch deficiency advance for on launch Mitapivat in XXXX. PK commercial of and anticipated and

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our in programs diseases are and are information our quarter, more research in the us and pipeline. planning host for to and activation stage PK our commercial development Day in and about advancing plan we Investor on share we metabolism an Mitapivat, research momentum. to cellular to and fourth for launch more sustainable detail growth defined deficiency In expertise Mitapivat talk genetically our about position in building Beyond earlier PK

the successor to update a decided a transition will Chris his Before Chris to an to development seven Agios, strategic Chris terrific the I pleased leadership a Officer clinical end provide our role I'm on team turn least after on retire part at to at of moment through share Medical programs, take from Chief our his that as advisor call over months, I XXXX. wanted the as over coming has period our years After a that remain team. to very of to

programs Dr. many He our an behalf of Clinical in now effective of sickle future. to Prior defined integral for at Agios, he strategy during externally, best years risk roles Biogen up is as and the to energizing out disease Sarah's programs. announce medical at and serving diseases. want build-out of wish his an him, development, and to genuine our for she genetically by increasing bring in with order to who medical X. Sarah to in to patients, acted a important the culture. service role excited our Agios, played almost training. key has our most oversaw has all a of management, with as as great significant PK her things contributions, work two been cell and evolution and held organization interactions people clinical an our our are inside Among part Officer takes his a Agios continue life from on She for regulatory now to I'm she this many at enters to internally Medical see of will to design of development turn years work that Among has safety neurologist representative Development and diseases, the navigated of his affairs, accomplishments forward pivotal team and responsibility new years and been has excited lead continuing Chief and tenure. in for this and passion leader deficiency to of I genetically Agios. September her, lives served look been of role defined for and complex leadership and chapter thank Sarah We for role that, the over level We integral he Gheuens, the and Agios, she will patients has I and Head everyone With the across knows medical clinical him played his as accomplishments responsibility. at the assume call with Chris Sarah Chris. come. organizations, new in impacting many of will the and all associated aspects organization for of On and the filings the and drugs Agios' equally impactful the of

Chris Bowden

Thanks, Jackie.

As in genetically community the Jackie mentioned, diseases. the we filing with for impact we EU. US important defined We are this regulatory to lives excited submission our the milestones individuals potential about with have past both Mitapivat achieved the of deficiency PK for global quarter of and and the Agios

share of MAA triggered that to the MAA procedure. the validation, review our start We are has pleased passed which

impact EHA, address we so data has are Information application that whether them to time. we PDUFA those been to significant in not about evaluating believe and who in Mitapivat symptom PK is and XXXX. the regularly a the have with published the with safety transfused all we accepted, to from and communicated respectively. patient very that hear we deficiency. regularly by including review, will look tolerated primary endpoints studies studies ACTIVATE expect agency the X the well granted of NDA, date Mitapivat is with deficiency, as both adults mid-August. life determine reported momentum, met studies are previously in and be data. who presented pleased FDA PK at secondary from consistent of profile whether whether the second ACTIVATE-T are we full the submission quality transfused, generally and observed priority Mitapivat For XX-days was their from was accepted, Both has Overall, the Phase and burden of busy application half our outcomes and progress At

heard During Glenthoj, to serve Andreas the PK disease of EHA the highlighted deficiency PK investor treatment current these has impact for therapy we significant from Dr. individuals. the on and the limitations landscape, who Mitapivat our event, of life, as also first deficiency modifying for quality patient's the potential

Moving to thalassemia.

EHA four gram all X dependent proof-of-concept previously achieving patients of core or at thalassemia. the our patients endpoint data, Phase on XX during and presented at equal more of XX. in also increase with to baseline non-transfusion per or XX of XX study announced in with met Consistent greater its through Mitapivat beta data deciliter X period study alpha primary assessments the We weeks a one than hemoglobin from of the

a improvements including improve and to believe addition, tolerated of potential well thalassemia, erythropoiesis. studies. response were a sustained treated profile both and these thalassemia In ineffective results underscore consistent with hemoglobin alpha erythropoiesis was Mitapivat beta also and hemolysis in Mitapivat. in hemolysis previous with with hallmarks observed Mitapivat of meaningfully and patients the safety We ineffective

in see in demonstrating excited generated this baseline in first hemoglobin to increase for in time We from are data patients an five thalassemia alpha also the all subgroup.

to Mitapivat controlled this thalassemia, in and and placebo sites as initiate the are of we of Our track year, prepare process trial two submitting global ENERGIZE pivotal enrollment. continue on for trial globally protocols these ENERGIZE-T,

trial randomize XXX than as of X/X Now had in of patients to hemoglobin Mitapivat study daily, will who The or X to a grams with placebo. this have XXX paradigm for screening. per the XX-months, in X initiate X We X, to analysis, for sickle or X.X X than Mitapivat disease the Phase twice Mitapivat to Phase XX.X matched will will X or data patients to of primary XX-years The of deciliter reduction to primary patients or randomize deciliter a clear the the Phase study X/X the within response include clinical equal the X:X cell The milligrams matched are Mitapivat in Phase end used believe baseline XX will the dosing XX as gram or of crisis dose XX sickle week turning hemoglobin two defined the year. selected the a the will twice after gram endpoints, to placebo. a portion. indication. The be have XX cell to past have X Phase the range X/X path during XX commence and baseline rate track maximizes will defined crisis. from with of which on deciliter X study week establish older, design greater approval endpoint and hemoglobin in the Phase age milligrams disease. this our annualized likelihood disease of and cell remain of Mitapivat this We greater broad Phase in label pain to daily, minimizes per per sickle between sickle Phase response equal cell to from change risks pivotal and to change X:X:X by challenging

In will in and core their provide the addition, has on Utrecht the Mitapivat December. safety, our work We presentation Dr. and cell patients at enroll cell the Chan development for of Mitapivat in with sickle and to study. collaborators completed the with with anticipate ASH extension submitted the sickle that people to continues NIH, at XX support clinical continue NIH of studies be to Data ASH are in in studies from we data datasets expected the disease. additional translational efficacy, study both at of enrollment At disease. the University

our ASH. generation submit Phase we're advancing year presentation Mitapivat, PKR The at enrolling for trial a volunteer healthy we next and data AG-XXX expect Beyond X began also in study. last activator to

AG-XXX Our inform healthy volunteer for the of will analysis of next steps development the the data totality clinical this molecule. of

fall, our talk As event this and detail pipeline. more will part research in of development investor we our about

working look the and fun watching and I for unfold. Darrin been I with continue for you has and thank over Sarah want successor, to so Darrin? last themselves. to story of poised to forward great to over lead commercial colleagues it to the rewarding our Agios privilege my our years. It activity, Gheuens, accomplishments Agios' speak of seven to the My to the team is all turn I discuss more Before accomplishments

Darrin Miles

you, Thank Chris.

facing We and on commercial Mitapivat PK infrastructure progress and and preparations fully customer deficiency. for launch continued trained. strong support to are hired All make in patient talent

well focused PK of Our of executing deficiency profiling potentially engage across US availability credentialed service field and of disease test team, patient kits disease of on support important an X,XXX with the plans become sales ID definitive help in An PK expect on the are accounts, ID. and are education. efforts. sponsored is to diagnosis increasingly testing comprised their genetic and accelerating now and support educators, physicians Anemia work through our nurse and important we over the With both profiling feature profiling now aid representatives with to patients patients a their clinical Agios Anemia requested, hemolytic deficiency awareness, managing anemia physicians patient and raising seeking fully program educating

been caregivers our they market of patients and to anemia XX% of based living on Enrolled use. with incorporating Our they efforts, with test diagnosis their important of hemolytic support, research patient tailored the infrastructure service patients support of patients accurate oncology resources technical field ease etiology clinicians patients its Patient future PK team portends inclined the is with designed re-imagined in of and unknown of other anemias shows and hemolytic relative the educational also patients insight, connected dedicated very needs a ID research, genetic indicated educational and trained our panel people caregivers support included learnings unknown are in and the a to patients program myAgios diagnostic create customized June, Anemia significant the which the specific for and our their while Support to routinely has the to connect Response with caregivers in of breadth we community. for physicians This to provide this physicians opportunities deficiency program PK how a launched ongoing favorably testing etiology. clinically much manager are order PK anemias with portion Amongst hemolytic deficiency. Services of to enrollment. and, enthusiastic availability the their now of to program, from insights myAgios the is adoption the that deficiency responding physicians leveraging educating responding staff including dedicated and PK with and community. and meet from their mutations on test In and can additional an of other of deficiency

diagnosing the This and of diagnosed two XXXX. academic to that encouraging now indicates with up which that approval they deficiency are in activities and indicating disclosure with insights fielded recognizing assuming the we potential patients. over and year. the to ACTIVATE familiar update disease deficiency Following physician than into general the the more half we it findings one community We physician support previously found awareness physicians deficiency manage period respondents market to metrics with is ACTIVATE-T in increasingly deficiency, at EHA XX% PK management of in next in months because to and leading PK Mitapivat's deficiency to understanding PK continue of for same our that new and and disease educational PK June, approval additional awareness time research XXXX improved implications PK are intend

based research physicians with on Phase transfusion with Our level. prescribing X will levels disease many the history of hemoglobin understanding deficiency that suggests of to respect and their including Mitapivat different severity, also patients consider to PK data,

in prescribing physician label on these increase responses Overall, across we've Mitapivat, overall efforts. parameters disease. and the While of each approved made by education to are of understanding and history, the for with response we individual and based the broad we're will progress disease the Agios burden of patient function presentation the encouraged community pleased of by be treatment preparations very from the launch the

we and do excitement coming as we'll to what complement full able the to to patients related in this expect be that field months, accelerate have growth ACTIVATE about the our the We for now in disclosures.

Now, to will to quarter I Jonathan turn financials. second it review over

Jonathan Biller

Thanks, Darrin.

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

million, increase results associated on Mitapivat disease second sickle second million, increase the financial by of quarter and with X were second for SG&A efforts. thalassemia primarily The expenses excludes divested compared basis, comparative which the and Mitapivat only continuing second as business. the R&D and for in general start-up quarter, Selling, to in flat our PK and $X.X our of as our cell our of essentially for XXXX. well filing oncology was quarter driven $XX.X Research of in the reminder, second year-over-year studies Phase from MAA the and million development $XX XXXX. quarter NDA to the expenses deficiency, includes preparation a costs launch of an our administrative compared As quarter results a for discussion was operations

$X major current need in to plan the Board We TIBSOVO million the on marketable cash In catalysts the Directors, in executed of which repurchases second With be quarter of item we the shares raise within and billion share recorded of cash, business to QX, the on and $X.X in by cash balance, statement. oncology million authorized the is line equivalents, royalties our positivity of Squibb. equity. to acquired with able We through expect of income of without income we securities billion. execute sale to XXXX, $XXX our ended from included also this up Bristol-Myers from approximately gain of quarter operating flow our additional inclusive $X.X to cash

an under at to repurchased approximately just shares, reducing average million of XX.X price by quarter-end. total our million outstanding Specifically, XX% shares at $XX.XX, XX.X we shares

questions. will period. depend for Operator, provides early at maximum ultimate we of our million over through share upon previously of the open of repurchases year-end The line the year-end. additional the please volatility XXbX-X in this share plan put approximately time amount share $XXX price As disclosed, in for repurchases place QX additional

Operator

Our Cantor from with Thank Young question first [Operator Alethia Fitzgerald. Instructions] Operator comes you.

line open. Your is

Alethia Young

or Hey little question on and done outreach or needs some kind work Thanks. structural, of physicians the taking frequently guys. to congrats Thanks all what needs of be education of people effect bring a I the do kind just, maybe you're done as that a of, to bit talk there is back of, there their like support. about for be and actually see is warehousing these kind doing care? progress. to my just and effort How a under kind to patient and Mitapivat these more want it people, for like

Darrin Miles

Alethia, to getting back in have be is with their more time with hemoglobin a to who've not continuing typically usually between The a going those they're regularly iron under come because this - see But physicians and remember, necessarily monitoring patients issue visits. physician, diagnosed plan, Darrin. span going are will attached those they're right. Those severe longer and they sort a disease physician of to severe - disease been Hey to more to load is under have are for obviously have less monitored. monitored, the longer some

isn't So, the frequency of focus. would physician where necessarily we visits

is We I from we make where physician-patient there. think relationship that education we efforts. need that I there fine And - sure the profiling, focus aware I need we to done, identification nothing delve everything follows and physician to focusing the into. and to that's that's on patient and disease. don't there's patient should need else think be The once think launch, our they're just and need to much to now we're of on what even education doing post continue,

Alethia Young

you. Thank Great.

Operator

you. Thank

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

line is open. Your

Kennen MacKay

Hi. question. Thanks for taking the

regulatory that your to with Maybe staying Chris, into Sarah you're looking the I'm with, year your regulatory FDA filings division? meet that hear on PKD. the to next off, but to about on which those Is the are disease forward hematology successor in hear rare here Mitapivat. and question for First one glad submissions transition. of sorry with departure, Wondering, the you or interacting quick branch

Chris Bowden

are itself cardiology, Kennen, renal Chris. oncology, The is in Hey The the we're with hematology and renal. FDA cardiology, submission in it's teams working that the divisions. the

involved interesting the are been an setup most and the because us it's with division. So, active on the most hematology who people in actually are have submission

Kennen MacKay

wondered around far. so I what some follow-up of to just interactions with going was sort of the is and That just

division PKD diseases speed have you. like? the Thank of got sort what You've rare on up to-date to and or interactions been

Chris Bowden

that has I team the with, and the joined interacting been group been been - for working us FDA, with The program has since with company. the - us advising we've with

with takes it you're the a disease nature rare So, in they and are very population. of special what the well when disease acquainted

don't they're have years, we concerns think why us a And an I heard any So, I guidance as group provide to it's as and consistent demonstrate people. to been the we trials need consistency the benefit, to a for as - make in think the you've designed and going decision of data them effort us talking about the there. over much to I have importantly clinical

Kennen MacKay

Thank you.

Operator

Thank you.

question JPMorgan. comes Anupam next Our from with Rama

Your open. line is

Anupam Rama

for Hi guys. question. question. broader so much the Thanks strategic a Perhaps taking

I us of price for What maximizing think the of on versus, justify Street for value the SCD indication. SCD so pricing? orphan your does of a ultra a account peak to Mitapivat in view by keeping to cut longer sales say, Thanks Mitapivat cut the much. meet in price have product many model threshold we the term to

Darrin Miles

able cut. would that least you just least you sickle wanted the breakeven, would right, to whole It peak only to account require, you require indications it less it assuming share sales be cell, the to X%, then move I would What What be from at market can than in we sickle would at first two is as to required, think breakeven and be tell premature what into that across about talk cell. in would for you program. be X%

we that accommodate is gain to competition. value incremental cell a so take once That's lot you sickle be the it despite the for optimistic be of So, sickle about able that move we doesn't to into size we're cut. will why whole because cell to significant able

Jacqualyn Fouse

real it's jump going in quick. just And Jackie, to I'm

on and at in this data said As the the pricing the we course. product have Darrin point that said Chris totality we times, that make clinical many profile time I often, those have of based of we'll decisions think and both

is with endpoints hemoglobin all outcomes, lot reduction, on imagine you So, of reported to there going patient VOC when you that. think about the all respect increase, and can that and the secondary

So, things the point some in about that think to when make pricing future. decision lots of we at

Anupam Rama

much questions. so Thanks our for taking

Operator

you. Thank

next Salveen with comes Our question from Richter Goldman Sachs.

open. line Your is

Elizabeth Webster

this taking is morning for then question. you Salveen. in Elizabeth at your Investor with And Day if in you. to This XQ, the for how in in us maybe if knowing of progress simultaneously you and more thank size on And Could could terms for Thank of just of and just patients comment many launch discussing Great. EU our you have you're launch identifying on that the patients? structure intend the and to-date? remind your and Good been sort both Mitapivat PKD? then PKD identified US you team

Darrin Miles

There's I is let can there, Alright unpack a this me lot you. Salveen, in see Got that. if so Darrin.

Let question me first. the with structure start

So, XX educators sales as and nurse that's just about earlier, internal a I collaborate external mentioned in will then US of under and right. small our we representatives, teams, with the team. for prepared that representatives, hired comments and That's our contingent them fully

we boots the already, For there shared the ground as previously, on EU, right. we've got

Mitapivat Mitapivat beyond to and launch that's given also we're right. we a that for that a already And MSL value particularly to we of the where in markets. focusing options, Mitapivat we've each after path So, dedicated evaluating That But engage been who's the to of experts major patient the of EU. that extends we or extending and number opportunity - that that our overlay the in to the their we've in the on already awareness that's Mitapivat hopefully - infrastructure a do EU to beyond shared exists with shortly our a existing of established in be activities, will the able patient partner, approval. Considering small the markets building we to EU, and major or footprint EU critical and have an have in able have ensure efforts extends advancing amount profiling or work, efforts. the continue been group value outside then that's be the include can team that got

launch and reflects a where partner transition So, bring. to deal of network immediately once have the pre-pricing. that find value in moving then we things believe idea potential keep that particularly And be can then able enable Germany we is - will fairly also launch to the but Mitapivat a the to sort you

Elizabeth Webster

comment Thank if to patients And could patient just you. efforts then the date? on identified identification you Great. maybe and

Darrin Miles

Yes.

those So, patients, we across continue we're that's EU and - clinical do identified profiling and the what able being right, selective move then the are we to do as is behind the we we identify of patients would that. what focus do attach to everyone closer where in as that wants here our that we've previously and really to us. more to and identified of top to That's work need more keep referred I physicians. about We because between the able inclusive particularly that efforts, patients. X,XXX And patients I we more though, US, shared patients on US to already it's to to an patients in pediatric important about, engaging well know be of come as patients as who hear enrolled various the launch each programs, with that number we as not patient

that individual absolute the further. programs you So but you ideally personal the the sense to their even we of and support then available use patient And to would confirm helps an to they're you to our then referring month ensure physician, patient population tested, want see in made to US. patients attach those get also diagnosis their want Anemia to and we've to physicians if getting - physician the in identified them program inclined is the last here see a better don't their value in confirmed ID that know the information,

the diagnostic we're up - focusing which they approval. the the to our lead education provide, that can patients the through that's Continuing myAgios then support them differential appropriate they and advance get those will to So, can where right. us that efforts, and that need, get

Elizabeth Webster

That's very you. Thank helpful.

Darrin Miles

No problem.

Operator

you. Thank

Our with next Michael Guggenheim question from Securities. Schmidt comes

open. line Your is

Kelsey Goodwin

slope is near-term, of this diagnoses you rate Michael. and guess do how kind off long-term of on kind building as a see for for I guess Goodwin what continue PKD the of the bit, actually you Maybe kind build of taking over that do these the question. next of our of of Hey, going this you forward one Thanks evolving Kelsey launch? kind assumptions in efforts? I

Darrin Miles

amongst six some that particularly think rate I'm from may is need in patients, with hemolytic outstanding available will who days our we're to we end unknown particularly with XX% terms and that I tested, anemia ramp continue sense The etiology. were I nine but diagnosis launch, then Anemia when for block seeking see we're is those the to less and a about in ultimately up like, not where when indication you're to testing. understanding early have those that between of from get when me what We PKD. - do of think medical that - profile months know those better is we who ultimately extend - made I'm which being reported diagnosis market the the ID, That expect patients. support its of indication help I will - ultimately everything to time in those physician facilitate accelerate, patients screened access good payers to have some to practices We anemia what hemolytic we that's to Agios that that new anemia, launch, doing to and going the are of concerned a treatment think patient. have that because diagnosed what patients have hemolytic first field look diagnosed now that in about Spanish require to the we're educate screening for will and were right thing exception contingent your a full the that and of a the on you're of IST we'll - observing educate number I still focused about for for you're we IST

support We've to going our programs ID, you work patients The in - better high. we to put the patients question treat treatment, desire testing demand this work. we the having physicians then The through months for Anemia with going of all them. drive, on time there these able to we to recent available be so And shared access have to broadly the awareness have for be opportunity to be so those quantitative amount the work time that the help first the for to script, the last patients. - in overall options in like the receive the So, is think, challenges. place is to got and increase the XXandMe the be demand in confirmed is I to

Kelsey Goodwin

it. Got

Okay. helpful. Thank Super much. so you

Darrin Miles

problem. No

Operator

Thank you.

with Breidenbach Our question Mark from comes Oppenheimer. next

open. is line Your

Mark Breidenbach

many the sickle cell us can trials us study trial good forward this before remain if how you to items And as expect well. to trial NIH remind morning see wondering in ACTIVATE on differences comment might on this are we're Congrats a pivotal for can the Utrecht gating the Chris, go to study? between just main can course from cell the later guys. the we this I'm disease, main initiated? see maybe much. patients sorry just that so that and with Hey, give the and you terms progress year, trial be data in of regard what sense and Thanks sickle you of with the

Chris Bowden

and now Launching in written a would agencies, finalized Chris And addition a the of come laboratory and that involve and that the is lift study, whole so to randomization the any your up your of It's translational the be setting with we're Phase up that's there's Okay. activities flow. list that X the of logistics X/X Phase studies. that the all medicine, things protocol, assays, are in CROs. operationalizing systems, here. all heavy study sites, global going thalassemia setting those in IVRS; the And of regulatory are how protocols

in country very just each many So, some individual activities. of and within complicated going of each sites, activities country parallel, it's at that them number them a series but of of individual a run through contracting and run you're can - in individual

key are and The and times takes too name, it that that activities of has be of up the team and patients that complicated It make we running. several to but are everything can in would some a accessible throughout terminal acknowledged that now sites really do well world. for there time focused the a to successfully So we it's everything piece done and trials our on all study maximum that have get many global identifying to look series to it's well-described is to have and patients velocity.

last patient important. patient important the and very is even in is out more So, the perhaps first

of area. well and sickle go at about starts and terms they look job. So, that's using well XX in piece group biomarkers ability are to as and and fun [ph] that's then of their for the piece this to red the cell a the sickle Then skilled as XX that blood of scanner and to at year. study components That to enroll to they oxygen at patients. Utrecht in then known go second terms and at in milligrams XXX metabolism look study is things other the both least then the up the trial cell, patients sickling cell that milligrams one can are will That very important on milligrams up doing XX

where the sickle study NIH the started milligrams, to in the amendment disease with then study NIH from different the first they milligrams. that's milligrams, with they may X XXX cell So, and adults milligrams where XX at XX study

of are an go of then there's eight then who weeks and and able treatment total a it's and into willing this can then taper patients So, extension.

you efficacy study give end the But gives talked important data the over think into patients sense think patients I of NIH how at of understanding of understanding more then Utrecht of patients that's of doesn't the endpoints about there's the study get day quite that we that go from immediately don't therapy many weeks further we'll safety The similarities some definitely extension. get and time immediately you because you from yet I on those eight both. of those who terms So, know chronic be. long-term a we are and a of going dosing and to in the lot

there. stop I'll So,

Mark Breidenbach

follow-up trial sites? Phase of very is Super helpful. inclusive African then the be X/X that, a going quick is Okay. just And to

Chris Bowden

Yes.

Mark Breidenbach

you. thank right, All

Operator

Thank you.

a James. question have from We Brill Raymond Danielle with

open. line Your is

Danielle Brill

unknown I guess where first And are and morning. Thanks good expectations are meeting you for AdCom then remind your that clarify of testing research or like Did Hi, Thank priority maybe would something review? for anemias market Darrin, us order to? an genetic much so can they what your wanted etiologies your from remarks, excuse the I that XX% for questions. providers your you prepared indicates internal to say already of for expectations you. me.

Darrin Miles

Chris leave and the then to first. to answer I'll me Let answer room for on able second the you the be one

give the more routinely means now and got those that of be would number mentioned who about reflexively. anemia with tests more then to for And further the are to definitive a genetic they means or of why insight provided we've an enzyme XX% unknown then folks both, indication community have receptive who I us is proportion do highly So, able audience to the they reason ID there refers then - which more panel of the either like, educating I what look Anemia are because try to uptake to to hemolytic patients particularly are physicians diagnosis to that some it which it. etiology, that a tests we out diagnosed ordering get but order a inclined or

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

Chris Bowden

Hi.

kinase Your pyruvate review question submission, was right? the for to priority with deficiency regards

Danielle Brill

Yes.

Chris Bowden

Yes.

view find we'll that days their timeframe, August or so. be from decision XX sometime out that, August of on middle so the should the in when So, we FDA's filed,

Danielle Brill

[Technical Okay. I Difficulty] guess

Chris Bowden

Sorry, we you. lost

Danielle Brill

What Committee are your Advisory thoughts on meeting?

Chris Bowden

we're in it's but sometimes get know. to the some so to too In stage you AdCom, early tell, early signals too yet early early on,

Danielle Brill

you. Thank Understood.

Operator

are Thank to I'd queue. the Jackie other Fouse turn no call there for closing the you. questions to remarks. in back like And

Jacqualyn Fouse

Thank you, the everyone, for this questions and operator, thank you, morning.

into As patients would with our like bright to colleagues our their next I for thank as difference with would ways. for us also look thank a making thanks in like we and launch difference PK And and to meaningful caregivers, partner deficiency lives all the with patients. I very my a our transformed so special a who for potential in to future, Chris. forward move the year. to diseases, in passion genetically defined starting we of Agios patients, many today making dedication a physicians Agios,

as with happy sure I'm his to with the engaged that at We wisdom he months. strategic to we'll next interactions pleased advisor over couple all through because continue a us is Agios him, from insight. very will have you very, of of and and end with more the We're least benefit stay XXXX and willing

everybody we you to couple look a few and forward today. So, next Chris, thank for celebrate much, joining parties us the Thank your very over next of months to chapter. you

may You Take now disconnect. care.

Operator

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

You may now disconnect.

Agios Pharmaceuticals (AGIO) 30 Jul 212021 Q2 Earnings call transcript