AGIO - Earnings call transcript Q2 2018 | Agios Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to the Agios' Second Quarter 2018 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 will now like to turn the call over to Renee Leck, Senior Manager, Investor Relations.

Renee Leck

Shannon. Thanks, and Second everyone, Call. XXXX to welcome morning Quarter Agios’ Conference Good

on today will who can call will Hoerter, provide discuss an our clinical Chief our commercial updates our our Chief Officer, milestones Medical also section and our financial me today's will update slides second Chief Officer, Executive Chief activities; development activities; website, Bowden, recent our for will Biller, XXXX be call our going Chief With Commercial You Steve Dr. review for and Financial Investors Officer, by summarize on Andrew who access for key quarter Schenkein, Dr. available are David Scott to Scientific results. will the agios.com. Hirsch, Officer, the who XXXX; Q&A. who the our Chris is business Officer, of Dr.

other like get from any make will as that result this with SEC. recent call started, including we statements with results various a forward-looking SEC filed Form that and differ other our Before the statements. and we I’d implied remind by on expressed events or could forward-looking to factors, section include make uncertainties statements everyone Actual risks, those in XX-Q those set most any and the we Risk Factors may of filings forth of the materially

David. with as turn be We upon this forward-looking obligation call our date. And that, only views any update relied today our any on should to represent the statements revise call to addition, made not forward-looking I'll any disclaim over In any as of views statements. specifically and or subsequent representing of

David Schenkein

year where in them quarter and welcome build available culminated metabolic And recent Thanks, out progress approval From organization a bar, programs support we XXXX been expansive a FDA we research growth. have rare Renee, disease our that next the Agios and making approved pipeline in that impact. development can today, laid second morning of across has initiate across treatment the whose multiple execution plan of lives we against to new targets precision a we oncology to important met the genetic our medicines novel and earnings Earlier nine medicines our to rich to labs stand this is of years phase an our good creating When call. we're in set that need thrilled medicines and goal aggressive clinical to of patients we trials out bringing TIBSOVO. everybody. of year, two clinical science-driven opened additional ago, options. to patients capable a of with

submitted Chris tumor to ahead settings are of Phase AML two of the marks at that AG-XXX, achieved the and for our There the we first second MATXA will the the quarters therapy enrolling the as solid notable targeted the gene to kinase is kinase In evaluate deletions. several earlier emerge more genetically patient deleted milestones. ASH. ACTIVATE effort MTAP two the investigational commitment research defined from IDH in ivosidenib our activator, work detail, pivotal clinical we're including sites. year anemia. in pyruvate abstracts portfolio, first-in-class an in population. important frequently X step with initiation a U.S. of also In of known in latest trials therapy inhibitor in year, set the ex-U.S. and cover for in inhibitors for a large year in comprising kick-off the escalation With important our MTAP a of to most we’ve and pyruvate our mitapivat, to During ACTIVATE-T chronic this these patients frontline dose The half patients trials deliver excited deficiency, our metabolic program and this oncology entered this trial AG-XXX, new cancer, first now have to

we disclosed commitment underscore novel At to tools applying rare programs disease research programs build to Investor our in approaches phenylketonuria, and ataxia. research. to active portfolio these Turning erythroid discovery Day, and Friedreich’s investment diseases. porphyria to our our and develop treating These

for of team, The from activities and for is approval began our shaping drug with AG-XXX, XXXX execution an the growth important now preclinical discuss the engine. ambitious to seventh to and research our Our commercialization continued and clinical investigational it fourth to our wholly advance represents this turn has of up is development be set our clinical activities. the our the goals our transformational IND-enabling organization I'll, to over for emerge and Chris on new a on-track product, inhibitor. portfolios DHODH submission our quarter support year first of Agios to owned to application work.

Steve Hoerter

David. Thanks,

X this MDS, difficult expanding The an accomplishments with important as data Journal ASH populations, typically number clinical durable therapies portion that to for an significant the most June, AML important to patient X data second Phase in responses England response quarter population underscores chemotherapy. one, usually rates, after and treatments had Phase key a or last in and was not initiations, are patients AML, ivosidenib generated by or agent any in as the data due offered journal and/or relapse and therapy. their study its IDHX these in myelodysplastic TIBSOVO's treat performance supported ASCO the demonstrated ability disease active return their other two of published Phase at and XX% overall AML, presented New AML untreated response cytotoxic We that in trial population. The AML of numerous MDS. approval, after compelling to secondary the addition underserved publications. out complete produce agent. mutant prior in multiple of and was to rate being at also had disease refractory syndrome both status presented presentations of Significant evolves EHA with and patients Starting with compelling marked TIBSOVO's challenging XX% A of including Medicine. untreated this were year. older and rounds data Patients in an ivosidenib patient a XX robust enrolled of recent comorbidities efficacy therefore their in are for trial, rate of poor an trial response a single condition X of single

a to In to MDS data package with acceptable clinical response, a of which end Phase similar Pharmaceuticals submitted have track of to updated in Out abstract presentation are enasidenib to responded authorization We this XXXX, X a enrolled based this is with on Phase lines longer with our focus the Europe, ASH signed license the AML. the trial, is with been we an Conference. our XX regulatory With And we European on to this and for XX follow-up patients. complete ivosidenib refractory five more globally an into outcome on development and an for to strategy year's will expand setting, AML impressive U.S. focusing a we trial Celgene for submission the at the also ASH X develop in of population. a high-risk step agreement ivosidenib data Agency. is in This has having earlier plan established or to to therapy June, on by and pursue assuming refractory and making Medicines commercialize the follow-up. and for patients in approval patients has or application with ivosidenib longer treatment. ivosidenib submitted access goal submitted China, marketing In relapsed available CStone important Greater the relapse

therapy. combination frontline four evaluating Our ongoing strategy AML planned ivosidenib encompasses trials, or

a this CRP. enrollment patients, impressive which XX% portion AGILE response a combining complete ASCO. arm in XX with and to our The first an this trial we CR, in overall at we data azacitidine, ivosidenib rate XX% combining Phase or the the supports X CRI and IDH is XXXX. ivosidenib are patients and The has ongoing these azacitidine, inhibitors most enrollment which X trial of Phase achieving with The ivosidenib expect study, trial completed of in in responses reported recently robust from of

X presentation is ASH. standard chemotherapy, follow-up IDH a longer frontline inhibitors both Our third abstract an combining at patients trial and has for Phase submitted including additional intensive with been

frontline followed initiate inhibitor as IDH cooperative both and standard will Finally, induction of agent. groups IDH with track receive combining X fourth single in by trial European a to chemotherapy, quarter. maintenance trial HOXXX, is either sponsored will on by Phase a phase, consolidation inhibitors a This patients where remains the

solid Turning now to setting. the tumor

trial cholangiocarcinoma underway. XXXX. in In a expect mutant Our brain Phase perioperative glioma, first half AG-XXX’s evaluating and we complete that and tumor ivosidenib in of we enrollment previously ivosidenib is IDHX are window and trial evaluating ongoing effects in is X the treated tissue ClarIDHy to

of oncology year-end. the for approximately in ongoing program adults, Blood, Phase follow pyruvate authorities, mitapivat. overview pleased transfusions. The placebo-controlled In kinase trials clinical disease-modifying plan receive brings on we a a regulatory from pivotal publication clinical in receive internal with patients for enabling data continue this XX with pediatric abstracts on associated by The open an with trial approach, the within the implications MTAP clinical input medicine transfusions. the to dose to PEAK us regular this up overload iron is basket the burden publication decision Consistent AG-XXX, XXX to strategy years two pivotal time chronic the sites least new only our deficiency. is from together by setting, multiple our trial. we with data precision who escalation History and deliver complements a of pyruvate trial for evolving for XX adult and understanding two and Phase anemia. global deletion kinase provide splenectomy inform first the Our lymphomas. for of Natural patients approximately comprehensive to solid the single-arm rare first enrolling tumors Study, in We not of this will X global diseases, from study in long-term who therapy ACTIVATE-T mitapivat to adults, a at pyruvate blood study disease initiated multiple genetic ACTIVATE a to see registry kinase consisting data across recently do is deficiency. on based deficiency. together our clinical highlighting were path registration us Blood regular a It pivotal X of sets approximately on Wrapping

proof-of-concept X to planning Phase year the strategy for on our the the has hand Steve over second forward trial been through part As track to we year. the commercial initiate of to review is our organization that in life which already this of momentum to year. are and activities. of now of across fourth clinical thalassemia, I'll it productive quarter a look execution carrying we half mitapivat, XXXX a in cycle

Steve Hoerter

we full in to excited our been on approval organization morning the call FDA commercialization I'm ongoing successfully effort prescriptions two across update our And had this the Chris. launch plan. mode And launch the that Agios, than bottles an the an TIBSOVO are into Thanks just the hours on Thanks that less cross-functional been join weeks TIBSOVO. TIBSOVO executing here to of approval. since ago. after first provide order of we FDA first to We've shifted the distribution written. receiving received incredible already same-day channel we at

across or incorporated of physicians country, this refractory into first-in-class approach the treatment team medicine hematology can senior and Our novel, for how TIBSOVO information XX relapsed be precision providing consultants about engaging with AML. are the the

feedback with the received their We pleased from has very customers. have the been team

of to-date, been we account national coverage payers to payer-related team are their coverage any understand for issues. And working with policies Our director aware TIBSOVO. not has

refractory AML, intensive in or TIBSOVO patients the And XA IDHX-mutated AML. recommendation therapy. IDHX-mutated with as recognizing with for induction new the In yesterday, who addition, XX this relapsed to are the candidates received treatment. disease treatment of remission their or a diagnosed TIBSOVO age include updated for just single IDHX-mutated published a treatment in not patients older newly of guidelines importance AML, NCCN category agent or targeted decline

As the strategic launch on progresses, focused is the team three commercial competitors.

especially rates, relapsed have TIBSOVO and TIBSOVO. AML or testing to to appropriate label; the patients community on physicians IDH refractory increasing in ensuring educating access the finally, First, setting; second,

sales the first net U.S., quarter quarter. Turning million representing $XX Celgene XX% to IDHIFA. the second growth from in of reported

we is for consistent with IDHIFA, our nearly Now are quarter-over-quarter that one-year this moderation expectations. post-launch of growth

team at Agios, medicine. first Before the possible. challenge I Agios to other here call And just close, I entire of turn At now side the over launch achieve successful has hard launch of for a work and our want with the ensuring thank their ourselves we that. the wholly-owned done team to of very I'll to Andrew. TIBSOVO, the

Andrew Hirsch

Steve. Thanks,

ensuring the precision we my I for is launch to securing commercial unmet of beginning translate medicines in full recent for TIBSOVO areas day. like our research This just our the I'd Before continue review approval for discoveries financial as quarter, into high the also and to same results on Agios needs. colleagues acknowledge the

can of will from Our Medicines second compared we issued The million driven in our factors: Agency included of recognized results be in financial summarize. XX-Q comparable period for to Celgene. all $XX million filing was morning, significant was quarter the release we Celgene's in found revenue revenue in collaboration XXXX, IDHIFA. by quarter, today. detail quarter later related to milestone More the filing this press for be $XX second will We European the for to which year-over-year million increase first, $XX a revenue I which the three MAA second recognized

development the recognized finally, million license resulting million to TIBSOVO we in and million. delivery revenue under with revenue IDHIFA exclusive in recorded entered Celgene the agreement second in the quarter, during to agreement of the We China. quarter. this $XX commercialization for Agios Pharmaceuticals June, related into And of an $XX $X.X Second, of royalty Greater for license CStone

Given return its to the upfront forward. historical the going run milestone payment, CStone in of MAA one-time revenue we collaboration IDHIFA expect to rate nature

ongoing to inhibitor was mitapivat of of for This for discovery million our We largely PK research same increased IND-enabling million and for increase XXXX. expense by activities the DHODH compared platform. deficiency in $XX development driven period our our across $XX to recorded efforts program, the operating second investments quarter the Now pivotal in AG-XXX, and turning research expenses. XXXX,

and in cash and $XX million, cash, investment with general of increase for securities were capabilities TIBSOVO. administrative ended $XXX an marketable of driven the the infrastructure million XXXX, and expenses by our from $XX quarter increased commercial equivalents second million. We of quarter Second launch

been here plans at end We will to operating the in of Agios. exciting expect the at year current least of balance fund It's first revenue expected that this us an half TIBSOVO our addition cash for XXXX. for

TIBSOVO AG-XXX Phase escalation trial, the initiation the the of of of With relapsed refractory and of or for for course, the start trials registrational X approval dose mitapivat, AML. FDA

We financial questions. thank Investor to to ambitious And are their like I a shareholders support. this you in With that shared open for execute plans line strong at May. operator, to Day on continued in with we position would our our the for please take the opportunity

Operator

from [Operator with you. J.P. Instructions] Anupam Our comes first Thank Rama question Morgan.

open. is line Your

Anupam Rama

and progress. the question guys. congrats Hey, the Thanks for taking on all

For the to have you event-free about guys move talked survival AGILE evaluating the OS a on from study, endpoint. primary

if regulatory get wondering update? much. Just any there's could update? an Thanks Or when we so

Chris Bowden

Chris Bowden Yes, good It’s morning, here. Anupam.

and with So we're still through working that the regulators. engaging

So any to it's this updates we on. something don't certainly don't any are have time, updates continuing at I have focus we –

Anupam Rama

question. for taking thanks much Great, my so

Chris Bowden

Thanks Anupam.

Operator

Thank you.

Suneja Our Bank. SunTrust next question with comes Yatin from

Your line is open.

Yatin Suneja

guys. taking Congrats Hey, the all for and on thanks question. my progress

new some questions, of Just name. the me a couple will time still with AG-XXX. I’ll remember to maybe start take It for

study, the of per think about and the ACTIVATE. DRIVE for X.X the of deciliter So DRIVE PK study looking in assumptions meet was the hemoglobin. you eligibility think ACTIVATE have achieved I And I criteria should patients, I the PK disclosed in threshold those trial. for powering increase at XX% the gram XX%

question could us as these ACTIVATE So you update I any time Thanks. data these the And the and you well. frame how have point another enrollment assumption? powering trials, with for sort understand help ACTIVATE-T? of helped two on And

David Schenkein

sites So up in the phase all of globally. Yatin, operational getting we are the

So we're accrual. around not ready to provide projections any

study, study. looking As population to according were the in the we the for able setting to efficacy from be design analyzed the results far that at ACTIVATE we saw DRIVE are the as up the certainly PK

study we study can we put up the we with that that positive. we touched be come will the you the in of ACTIVATE and develop eligibility criteria projections some some can on how of take So think that

of mind think arm good a placebo is the perform. placebo how fluctuations idea some aspect don't arm, – in we other I pretty to hemoglobin. in there's expect the have keep also the general in that we will But

power this the in study benefit think design us has adequately demonstrate study that population. mitapivat will clinical patient to that and allows we certainly the with important So be we

Yatin Suneja

least then IDHIFA in the is, I anything the maybe seem more some bit the And not terms it. us suggest give that a a you be in in using quarter in little in marketplace unit academic seasonal little and that bit Donnatal you at reimbursement you patient close impact an high-risk are and color in consultant QX Can think, And from of particular IDHIFA, Got they issue already front-line on more on terms seeing QX? to are perhaps you does there second our are the see, academic. color can growth the of drug us on then that for there? what to give question

Steve Hoerter

the Yatin. Steve. Sure, Thanks question. It’s for

the the be Investor color how that it's we we at subsequent of So We'll performing, the call. approaching with you and are the pleased IDHIFA metrics in disclosed growth, don't performance, I seen on year that first we've unit have have terms similar really a the respect second with post-launch. earlier are updated quarter for to add continuing. would that on growth I to with with those – now to quarter-over-quarter. this quarter I continue one revenue we how metrics that drug is consistent the But growth Day year. is pleased

So in in a community. as in time, just likely mean, we that's that uptake pleased is we remain really seeing I we're with would increase the centers of testing rate. academic function exceeding progress. expect, what And awareness,

which their of what use I from work hearing very in your the So consultants of the the think drug the active respect teams. outside label setting. about commercial and front-line Yatin Celgene academic in question, an Agios progress you're is to for related combined much second this to With

neither use that's or Agios promotes It's are Celgene reimbursement physicians unsurprising there. seeing that a to. that me in to not a sense Of course, those challenges

earlier, XA does intensive me would Category doesn't surprise population patients combine it And listing also in monotherapy the front-line potentially who chemotherapy. chemotherapy not then are patients. with drug or as as know, As in seeking physicians with in you for of have that eligible HMA that we IDHIFA disclosed to the setting be

Yatin Suneja

help P&L, you track Andrew. then able are us Got And service? much. mean we a then an with And question Thank could the year? to very third-party final a for for one to the using you prescription TIBSOVO, QX, much, it. uptick that I of the guys. for forward, R&D very bit rest little bit, good in of with is especially going like little seems regard a Thank proxy you Andrew,

Steve Hoerter

tracking. Yatin, it’s TIBSOVO Steve. on question I'll Yes, take your

And drug, have the previously, special as product given that the of you so spoken nature relatively as have channel and population distribution a serving. about the we're for know, we limited we the

nature So we through specialty channel, distribute the specialty wouldn't the of well complete drug as result that. through a as as And that distribution pharmacies. the IMS would have both data, we given have very expected of distributors prescription

the not result taken as with partners have of channel any to that. level decision a we've share our script so data parties other And

the providing launch. with updates usual communicating our TIBSOVO be be on we'll So how and the quarterly progress call our we'll that's

Andrew Hirsch

this Yatin, Hey, is Andrew.

IND-enabling Yes, quarter in see question by AGILE AG-XXX. and R&D well as on the some the just ongoing really that up including activities driven Phase clinical your uptick clarity, research for enrollment of AG-XXX ACTIVATE startup enroll, ACTIVATE-T trials, starting continued X the an to in we study, as several and our perioperative So trial was now running activities, this and did of spend.

run activities portfolio. continue level probably of I across you given the going R&D could have expect that all think to that we rate So at forward kind the

Operator

you. Thank

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

open. is line Your

Kennen MacKay

and expedited congrats you for thank very taking the TIBSOVO. and recent questions approval on of the Hi,

Steve Hoerter

Thank you.

Kennen MacKay

Two quick questions.

could approved was wondering wondering we side HMAs escalation help change the data? potentially internally with secondly, IDH could about the should the to just maybe even potential And of on MTAP if then us some initial I on into biomarker business, if of in ara-C, once you what and escalation? that color First data? or AG-XXX when just of just the Or data it's kind was the enrollment presenting we treatment if from think be paradigm you dose dose about like lower it’s thinking combo for that how AML with would any the see dose there to venetoclax initial or before

David Schenkein

first little Thanks about a Kennen. Steve answer Maybe venetoclax. question XXX on and can talk then I'll your bit second

XXX, to with first bring of with to going makes medical meeting. what our we're – is we've all enough predict, So that it said a in-human when hard to major it to have really data impossible historically that study fact sense in

we enrollment in As began the just phase you dose March. know, in escalation

early So escalation. data. dose we're still But when we're commit early to likely really well. going on too to it's are in Things see

PK, to having makes PD for is us meeting. both this a investigators it that the us So the trigger to data, enough sense bring and safety, to

And put are Steve out any to. so have to we can And we're early stay about Things and well, also it. too going Chris but going then maybe if I'll tuned. need talk just a it's venetoclax, add bit see of little to when commitments

Kennen MacKay

David, just again, that sort that could it to we a on the that follow-up be be should thinking would too of patients? those say? following just XX of potentially Or in be early or front initial MTAP, accrual to quick

David Schenkein

early. too Again, it's

it been back bringing really a escalation and studies, data presented there's where escalation look historically warrants ended too mixture presented X you at we not to premature. and It's we having Phase hangs is our ones really meeting a those medical together ended. before after If that data dose where dose that of enough

to So say on. this really impossible point, it's it's at early just

Steve Hoerter

other Hi, answer to and the Steve. I’ll AML. respect your with question Kennen, in landscape it’s

medicines new treatment this course, you for venetoclax last know, seen number Vyxeos, RYDAPT, referenced Mylotarg, disease, of you and As you the of at look IDHIFA months, whether the XX then, to coming. a we've approved of over XX

for is is been is patients. news this – many, many our in years. This So great for estimation, underserved this has a patient all that population

is and new the them. FDA fact great treat therapies the patients And we for physicians that for now so getting news approved have who by many the

spoken that's IDHX Specifically, to mutation. disease that with this from physicians that we've that mutation medicine to and is what we've venetoclax, with IDHX in there is large an an prefer select mutation that respect by when identified or that actionable physicians heard like a targets an

expect the in this case approved we so disease. that to continue that with And other get be to drugs might

Chris Bowden

just a I couple to here. things. want add Chris of Kennen,

We changing is landscape targeted have of for trial X the combinations as and our a terms of because test and landscape Phase positive try ivosidenib MD like of Mylotarg, activity of the the the about new of to coming at lot outcomes to ongoing combining We how of strategy drugs Steve overall that other different part as that's better a talking horizon patients. new Anderson further on in treatment that's a et plethora and given needle as have molecules venetoclax with patient in anticipate a terms in Vyxeos lot of well thing therapies cetera. come we by the move

Steve do to as overall, take good stated, for work of our it's lot So patients. is, and

Kennen MacKay

question. maybe final And just one

other approval one reimbursement there? companion your the if such the then sufficient we or I diagnostics? wondering only of recent what to And as this sort current sort to of the perspective looking testing strategies percent of for of approval either diagnostics sort of of additionally, using XX% than for IDHIFA TIBSOVO, IDH level the only obviously, aims was IDHIFA in-house guess, of are IDH rate your looking approved And the testing, and or we for IDHX were when population as sequencing historically forward. limited of moving any back current diagnostics from companion three pretty IDHX. Going of had the IDHX, with and of this maybe increasing be sort – increased of can on XX-ish to sort

Steve Hoerter

Yes, thanks Kennen, it’s Steve.

I'll year, were you. talked for recall, your close we with So IDHX at respect we testing had Investor the respect testing With data we questions that which rates, relatively as about rates, that this we Day XX%. there then expected had you earlier to answer and IDHX that behind time that to will that. at were rates we disclosed And about that time testing

data have So we testing and at setting to for moved updated at practices you I what that I don't we'll other will we updated have generally over hospitals would on have grow expect to those that panel call. data some testing. know continued and rates to subsequent but that happening major say be a in today, time academic have centers is that

been if the case, not say panels. including for incorporating months, a I of testing into IDHX So would that's number years, IDHX those and

so – that too that think sort we of sort to similarly, course, that, of labs, myeloid that large commercial we the then practice about expect, offer And And panels continue. when incorporated IDHX. they and work of IDHX

So this products. tests approaching and in flourish testing continues physicians both with these specific as the determination marketplace IDHIFA, that their to to make how lab-developed promote and what academic But whole centers in tests own ways they're they that is see and use. our of in community we use course, companion going to labs and We, of and are with indicated diagnostics for fit. settings, TIBSOVO

Kennen MacKay

much you for taking the so Okay, and thanks the questions. color appreciate

David Schenkein

Thanks

Operator

Thank you.

question with comes Mohit Our Bansal Citigroup. next from

open. is line Your

Mohit Bansal

question taking have my progress on for and well from my quick as a on Great, end. I inhibition. the MATXA thanks congrats question

there but understand I'm tumor to in why out wanted result MTAP-deleted that PRMTX out mean, – is there Just are not I mind? in inhibition why is literature reasons general you the molecules growth direct what inhibition did there, is you reason it think this or some the to do just not trying inhibition in specific is in a the your And there do direct of to the more used was PRMTX here? right understand of plausible think there, strategy?

Scott Biller

question. Mohit, that will Yeah, Scott. is this And take I

an it's don't active. being selectivity. issue So, It's we not think about PRMTX certainly of inhibitors

to cells. neural an inhibition metabolite sensitivity replete MTAP MTAP to there's methylthioadenosine. of us of special in MATXA gives cells, And relative level this elevated the So, the

demonstrated and cells MTAP So are will have PRMTX that to cancer are deletion they that body We those The been expect and be MTAP and the particularly all in don't cells spared your it the sensitive. selectivity. cells opposed have that other cells. have hasn't cancer inhibitors as the

therapeutic other. whether whether it's a you active not the get with to about So is one not, it's or window relative one

Mohit Bansal

Got it, I change but KOLs this to earlier is drug gear be in more this setting. understand if a very discussions helpful. In the could our thalassemia. with little bit that then could And, helpful, that like mentioned they do they

a understand there two the is mean, rather so strategy with? things this for forward Or I the to would price be in deficiency, I strategy same life-cycle a will go good you than forward? to you. management here what pyruvate molecule Given do will move going you in kinase Thank with And terms data molecule? have like more be want is, the you of

Chris Bowden

Mohit, it Chris Hi, is here.

provide view a pyruvate disease. defect. Thalassemia, demonstrated of pathway due trial had in associated thalassemia address wild proof-of-concept type pyruvate in the to in that ameliorate anemia an hopefully our preclinical the the through basis work, interesting pyruvate effort the with some genetic And symptoms ATP on mutant activating we're sense kinase activating, more this kinase a and very restore, signs looking and of may stressed So, study. that it’s at cell deficiency, to kinase to

testing we're that that pretty in indicates good and comparable to have the effects data now. Our are on we a clinic anemia some in drugs preclinical

level landscape. that there's take many we at a this evolving of at new data molecule. look to it the me to for operation we’ve we'll not next generate know, certainly, got early too we're launch as the in now, approved are cetera. the et data course, of our type quarter. we about mode, would you there along with fourth of getting in and therapies talk coming to study And much look trigger what have development, at point. it's But So, the ready Right And

So, we for the terms drugs steps. we next efficacy a rapidly and when we'll and decisions in molecule and proof-of-concept Because are see field on can wave have we we and in data before demonstrate development. for of where where our of are our get to making new terms safety this next data need some of evolving first is decide

Mohit Bansal

This it. you. thank Got very is helpful,

Operator

Thank you.

Our comes Sachs. Flynn Goldman from question next with Terence

open. is line Your

Holly Barra

for so thanks taking on This Terence. is Hi, much for question. the Holly

the at what we forward? glioma. to SNO on program November? Conference take in Thanks. AG-XXX Should one Just you looking update a for And an quick can for remind you're expect this us,

David Schenkein

your Holly so questions. Yes, for thanks

So, submitted come presentations and there of the the meetings, medical that's all presentations be just to wouldn't outlined not fruition. them all but year. have today, during dates yet as know did we you some We the will have been assume submission abstract that release haven't out additional the for in comprehensive put because I

So we'll update that.

to developing certainly we’ve SNO glioma. will meeting, that respect the it's data pretty at other XXX much With or is which be year. in So every where to XXX relative attended presented possible

stage you to the have are next the use head-to-head perioperative that molecule we a into XXX bring data we're is comparison ivosidenib at for determine, study ongoing As and looking in and which going to know, of an in to development. surgery scheduled patients who appropriate

that be as And So the which able to be once we to stay tuned. then do as going give update will We in data the well, able study, that. soon to completed perioperative on hope an possible. is very is

Holly Barra

much. so thanks Great,

Operator

from [Operator Newman you. question with Genuity. comes Our Canaccord Thank Instructions] next John

line is open. Your

David Huang

Hi, this for is on John. David

trial at Thank et levels you potentially PVD quick you. guys hormone same are measuring aromatase Phase the of Just in question Phase in a detecting for in inhibition, cetera? frequency X X as terms

Chris Bowden

it Hi, here. Chris is

a We with we're the will ACTIVATE hormones to steroid be in similar manner studies tracking in ACTIVATE. doing what

David Huang

you. thank Great

Operator

Thank you.

with open. is with next Van Piper line Tyler Jaffray, Our Buren question your come from

Tyler Van Buren

could general MTAP remind what even upon taking you qualitative program. the just sort thanks or in I preclinically morning, And had good at? And to to program? for questions. or some range guess, just Hi, question understanding levels respect specifically now? therapeutically, range X us where with to decided in a Phase we perhaps where I you the talks perhaps you start respect dosing for ongoing XXX in saw that you dosing and to based with of the relevant of define allowed are the that that right the

David Schenkein

are terms before of more Scott dose exact discussions out we a that in very I agency, turn our give the the after it to Look give we lot with details in over we you don't begin details, to of with pleased. general,

give more flavor little a have me let So Scott you bit there.

Scott Biller

that Yes, MTAP-deleted and multiple And this against use tested robust hi, data of we together models. biomarker saw a Yeah, antitumor is data clearly tumor across we guidance so new in exposure efficacy, activity to that with required follow on AG-XXX to number oncology models pretty the preclinical safe provides at and starting guidance. an and for give elements FDA that's work estimation get near we doses straightforward Scott. just

unusual. really nothing So

David Schenkein

would we that's I say discussions the very allows our had clinic. with have into date, the safety agency we to the that molecules our we pleased very and with the package we as what to and us have been with all had molecules bring pleased of

Tyler Van Buren

distinct for is MDS think the how that and Could And magnitude ivo the maybe opportunity opportunity? you about second of discuss do you this question. the potential

David Schenkein

of And offers are that The stages the And Well who syndrome. A, is, think, are data older X%. not data. around to often AML. options to were where our patients more MDS of comorbidity, benefit in that we prepared have later talked potential the opportunity, myelodysplastic frequency about tends of a my is lot generated so very patients seen patient treatment I that be improve especially advanced by the phases some The there we of frequently so again, far, predicated I lot is have remarks. X% that we efficacy and to myelodysplastic group in IDHX detected It population. for a in mutation the in opportunity on in in a drug clinical of syndrome the of magnitude to progresses this encouraged data fact

positive and Same from IDHX another as how for by the terms we're of of our and encouraged certainly we're in myelodysplastic lot to early going the move their data academics of potential this So well. community there syndrome. out IDHIFA for forward. goes thinking patients we're treatment a option with interest There's

Tyler Van Buren

Thanks again.

Operator

like showing remarks. questions And to Schenkein this I'd I'm further at closing currently time. back no turn to David over call for the

David Schenkein

operator. Thanks,

progress trials. all passion patients have all and today physicians us as rest of patients. I'm built confident bring I dedication I'd for like to participated way Agios organization and good the Thanks you and for ability for of at our summer. their caregivers from to especially to in and thank difference the again. clinical joining to do again a And make hope the the a Agios and our medicines, an the to lab all validates want this patients, XXXX in Our the tremendous who to employees thank

Operator

this Thanks concludes today's and wonderful Ladies day. for conference. gentlemen, your participation. Have a

Agios Pharmaceuticals (AGIO) 2 Aug 182018 Q2 Earnings call transcript