AGIO - Earnings call transcript Q4 2018 | Agios Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Agios’ Fourth 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 would now like to turn the call over to Kendra Adams, Senior Director, Investor & Public Relations

Kendra Adams

Shannon. Thanks, and fourth everyone, call. XXXX to welcome morning, quarter Agios’ conference Good

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

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

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

Jackie Fouse

be across Chris his the has Agios. is excited and business This I science particularly heels on product endeavors. morning, and good my leveraged and at us of of first call join the building the activities him the each position in a this role further company's invaluable what to wholly-owned XXXX the I'm and our commercial short would incredible years, like notable patients appreciative which to be INDs, am value and team Steve in create making to to Kendra. our contribution a deeper strong strong to and priority achievements impressive two to in for in Execution in describe look accomplishments proud to approvals has Agios shareholders. the can of launch of Thanks, the fourth seven call. today our including into this highly as patients continue as to XX everyone, determine my wish will comes from growth and continue CEO new is The keeping are forward and in quarter creating thank CEO. today to what it earnings fourth welcome and take And successful My quarter, long-term do. accomplished also initial on success more learn put member team. listen to detail. for and what value, the I diving future I'll this core commercial foundation. we discovery, his clinical in David Schenkein of perspective I be in opportunity I'm from Agios to how well new

our to opportunities broaden structured and within portfolios. oncology genetic the are priorities disease XXXX Our rare

And we plan under The for with year. and approval to working assuming in year TIBSOVO is second review which we're for expect tumor treatment in to frontline the for standard the initiate this are patients settings. grade are we diagnosed of by vorasidenib opportunity solid AML year expected First, who the advancing low by We is study newly Phase IDH in are the glioma later supportive. X cholangiocarcinoma sNDA sNDA not end end. a to the into data currently expand and or AML submit line TIBSOVO eligible CLARITY an trial

we respect trials, to adult PKR patients in ACTIVATE to we market proof-of-concept trials during AG-XXX into first pivotal ongoing XXXX of program, complete ongoing the Phase in expect for trial. By phase with Phase end we clinical Next enroll of for programs, altering to for goal both deficiency the in therapy thalassemia. in mitapivat as achieve PK the continue X first chronic well and the bringing half our disease MATXA advance as expansion ACTIVATE-T two of trial mitapivat this our the year X ACTIVATE expect of inhibitor the anemia. earlier enrollment to our in With

our on X to AG-XXX the addition Phase track in half DHODH inhibitor enter In in trial lymphoma the is year. clinical a of first

science. move Finally, robust pursuit through true to engine as always stay compounds our continue we the to will drug and great of discovery

an over provide on our strategy call I would Chris, update Europe. like the turning Before to to for commercial

the us to aligned our rare will position for necessary We the with European milestones relapsed certain and on be gated Following TIBSOVO have associated and adjacent believe will TIBSOVO of the our our maximize disease this against and for own of allow patients authorization the The application across of decision genetic business commercialize application. with EMA the future AML, made our well the potential for oncology launches programs. in submission review build in infrastructure we countries. and planned full refractory value TIBSOVO us marketing and to or EUX

We now activities. over share initiative to clinical with Chris plans details will our discuss you I'll it on important this to more as our turn solidify.

Chris Bowden

for broad setting. where the the will include of opportunity clinical the TIBSOVO our next steps and expanding outside strategy I relapsed refractory with moving AML start development to our US AML Jackie. Thanks, frontline

and XXXX. we at AML of mutant As for end Jackie mentioned, MAA or IDHX relapsed submitted TIBSOVO the application refractory

one CLARITY validated from questions review the during the on Our have and day With application quarter. Medicines we review XX been underway. for the the listed the timelines validation agency by has now process is and European second Agency the expect procedure this

addition access our to have goal is I In IDHX refractory relapsed to mutant AML ensure all TIBSOVO. patients an AML, to with

an pursuing we one So Today, other three treatments. standard into in and outline comorbidities strategy for therapy that setting the frontline factors, age, patients I will for diagnosed newly based are intensive therapy, ambitious development any segmented on categories, you. of non-eligible are AML clinical and non-intensive

today Our the the to goal receive patients is both labeled not approved therapy. setting therapy do for to first indications in and and achieve TIBSOVO intensive who be active non-intensive treatment

above At in where combination begin in encouraging X CRI is rate we CRP a a standard XX% last and with year care combination as CR, chemotherapy therapy, Let's data TIBSOVO reported demonstrated intensive IDHIFA where TIBSOVO arm. X+X known with our Phase X+X. study ASH we of the of plus from

who and non-intensive the stage expect Phase often agents patients therapy tolerate or hypomethylating minimal patients Co-operative Group's disease to CR for elimination Additionally was setting, we achieved aggressive such randomized by able in TIBSOVO. a residual CRI, run chemotherapy This also AMSG are quarter. observed the suggesting sets a to with and of responses of In CRP HOVON X durable the deep azacitidine. which the subset not initiate and this study receive as agent

the now we patients could achieving mutant TIBSOVO’s mechanism of the response revealed of with % rate a in deep longer where of CR, XX with IDH demonstrated a exploration a molecular CRI, study and we've these no preclinical the azacitidine CRP combination significant Phase detect X clone. Our rational portion

We profile the XX of the addition, remained CR, is IDH patients forward place of Munich. is months. XXth International up expected duration as Phase patients follow with consistent all safety In profiles in up to impressive at X CRP the look CRI taking of Leukemias data sharing Symposium cut-off this The on Acute month data with to longer with as or agent. azacitidine treatment and later as the of study each and on combination the on these known the

to mirrors and enroll on multitude In trial in with we AGILE therapies enrollment that and market, with believe of focus appropriate. adding we've targeting multiple of and he X will as the seen future patients expected TIBSOVO AML both new targeted agents Phase in XXXX. treatment entering on therapy actionable combining settings as non-targeted complete cancers a a experienced Our non-intensive continues myeloma. intensive the mutations other This such what azacitidine

a supporting approved and other TIBSOVO XOSPATA. with medicines Venclexta recently broad that strategy we're such, As combines such ISG

not reviewing timelines to the of newly the patients any for Phase AML on we TIBSOVO is month. process have for Finally, approval are standard expect X who eligible sNDA our clarity and treatment, diagnosed on this later the based the in FDA data more

oncology progress of FDAs Within patient to the solid this reminder, real be time our the also setting. tumor pilot would significant is new targeted made therapy As the program, this population. we've important frontline first in in be and review approved portfolio, part IDH a submission

previously and treated TIBSOVO CLARITY is X fully mutant Phase trial enrolled. now Our evaluating IDHX cholangiocarcinoma

TIBSOVO a XXXX. has the from therapy a positive to at first to this a line complete year we'll report top in NDA to supplemental by expect first the we half the be in of meeting cholangiocarcinoma year present clinical in approved end a potential trial more and half the the file the of assuming targeted the to medical second are prepared We and result. update of data study plan

study ASCO have annual June, of we approximately Data of glioma, perioperative uptake taking and drug been have tumor TIBSOVO as forward IDHX for AG-XXX molecule mutation. low reduction XX% vorasidenib, meeting and include known place this in patients indication, to which the also levels of the of in we on the in presentation Turning brain will tissue. as in at data vorasidenib where announced that January in 'window' the relative go grade Chicago submitted an selected from XHG

and chemotherapy in glioma As to vorasidenib wait suitable watch a need radiation a grade utilize reminder, the for to approach. are who for our patients two delay goal treatment is and

the We effects include are and pivotal driven tumor survival design the will event growth such working as with imaging. progression regulators in on which using process on volumetric free trial endpoints of

advanced alignment, by of this to the field. move potential that Assuming get is disease and approved end program the our we in now to this has genetic the activator, most initiate I'll mitapivat, PKR be medicine plan trial our year. first to rare our we

PKR is potential the have XXXX benefit. opportunity of to our in patients mitapivat activator broadly goal the who to Our to expand

ACTIVATE-T patients Our lifelong approved in transfusions significant disease receive who year. initiated complete initial focus end the burden a mitapivat in with by anemia is and thalassemia year. of ACTIVATE in mitapivat has studies deficiency, do pivotal on transfuse regular adults this achieve to no pyruvate of half and in of to in not The hope characterized we proof-of-concept which and track kinase treatment this options. with been second currently and enrollment indication by December study of the the regularly patients are We the in

patient population. deficiency We PK an be advancing XX this of in an mitapivat appropriate of pediatric also next generation in January, the which preclinical with range working strategy important and PKR also In plan with in development design is development through IND of to to PKR we'll regulators we this activator mutations. to molecule clinical anticipate a the unveiled currently next for development goal wider a addressing months. pursue XX submitting We

clinical advancing addition two AG-XXX, we're stage development our inhibitor oncology In inhibitor. for programs, stage untapped AG-XXX, programs, tumors DHODH our of our MATXA to and later early deleted

For AG-XXX trial quarter. we multiple study end the and forward the AG-XXX phase basket to expansion the agent single year select of the types. One and will expansion phase across dose by last a selective in of study initiated we trial dose second tumor a Phase the at go escalation begin arm the X expect the of dose

focus In X may Deletion. on Phase the XXXX, AG-XXX of suggest the our with half to XX AG-XXX assess Xrd will the strategies the annual translational Research combination arm the an clinically XXXX program for tumor. with from solid for of Association presentation a efficacy This in actionable first data the some of of expansion finding second AG-XXX oral will clinical Cancer further been dose other data ongoing enhance we solid combination through at expect taking which study. American tumors accepted of the meeting from has care that the present in Preclinical portion standard March April The Atlanta. in MTAP place presentation escalation

first Turning We the to the IND the turn at to FDA Steve. end the to over With AG-XXX, our XXXX half the the I'll to are on Phase during of year. DHODH of development enter X call and in submitted that, track inhibitor. lymphoma

Steve Hoerter

total to start patients update an US. TIBSOVO $X.X on quarter, to fourth strong focus $XX IDHIFA recorded mutation. and AML of first refractory in first-in-class in their with has to months be the XXXX in the of used Celgene. TIBSOVO team on relapsed of the for Thanks, is Chris. million co-commercialize or the like an five been Their we bringing In revenue, revenue senior launch with medicines July, novel hematology raising sales the benefit of how these which Since our launch. educating I'd with awareness we launch million with on consultants can precision physicians IDH

of from than the launch XXX result hard of XXXX. work end the third of doubled unique on a TIBSOVO, prescribers team's to number As our as more prescribers the of the quarter of

unique As launch. X.X a as IDHIFA comparison, prescribers years there approximately were post XXX year end, of

number unique the of has the TIBSOVO settings. are growth As seeing we prescribers in and both of expanded, in academic adoption the steady community

is As been for of previously a use and high physicians we not testing actionable mutations barrier their with patients testing approximately noted, for has IDH mutations. these to XX%

the opportunity in to vast community majority their drive patients are such IDH, for testing an we setting. IDH as mutations of academic rates have further While the centers screening

both very now to reflected are looking or and AML setting the year. in diagnosed have launch relapsed this with products that the We sNDA TIBSOVO forward the population established in foundation and our the refractory newly potential pleased

Beyond opportunities AML that, Chris to cholangiocarcinoma. these segments I turn in progress important on call to we Each are provide from you the us is that as patients ongoing quarters. for now believe broader benefit for the potential who forward about, to well there of I'll expansion updating therapy. as have to targeted in spoke frontline potential into tremendous to Andrew. indications TIBSOVO this over our future the look

Andrew Hirsch

Thanks, Steve.

can increase which full summarize. we press fourth in Total in of full compared increase was quarter More million $X.X million an today. of be million, our IDHIFA revenue XX-K will of driven year of the million fourth by million million, from the increase million to US I'll the increase release detail million EMA. US $XX morning, the of and year a million of related Our collaboration quarter XXXX we revenue year-over-year this $X June collaboration included results in collaboration, The was with in net TIBSOVO Cost XXXX. A million CStone revenue, issued later filing was IDHIFA and $XX $XX be consisted XXXX. for in $X.X which to Celgene for for and sales $XX financial filings payment which the XXXX. MAA $X.X primarily related IDHIFA year revenue net fourth sales the the million for full of found sales of revenue. a and $XXX,XXX milestone Total of in quarter $XX $XX.X to royalty royalty. TIBSOVO, our of $XX revenue the signed was

the research for expenses, $XXX year compared XXXX, the full XXXX. AG-XXX, $XX operating to and increase Turning an year-over-year fourth quarter in XXXX. driven expenses $XX by administrative represents and general Selling, million full This programs. $XXX of were year increase TIBSOVO. fourth capabilities ended commercial XXXX, $XX driven quarter platform full our $XX for and increased by over infrastructure the million securities of increase activities ongoing largely R&D was year full IND the to mitapivat was million and R&D for We discovery million and the start for million year our our efforts cash, quarter thalassemia of of up for PK $XXX and The with clinical marketable across the activity investment the deficiency a million activities trial study. enabling for million. in equivalents for DHODH cash and for and launch inhibitor our

With for this excluding product of that specific anticipated revenue addition end through expect open payments will and fund least cash expected please the current the milestone We program at questions. plan in operating but that, balance our operator, lines to XXXX. royalties,

Operator

from first with [Operator Kennen Capital question MacKay RBC you. Our Markets. Thank comes Instructions]

open. is line Your

Kennen MacKay

you Thank the for Hey. taking question.

the and out the late and us help on the one helm powering call. PFS maybe you in Chris the second at maybe year. for arm wondering earnings that assumptions of for in you? here are And was could And taking all control differentiation I I a impact was for on first if warnings on any just Thank commercialization. Jackie to syndrome Steve How the trial? understand if last you. seen congrats off, on FDA TIBSOVO one cholangio. cholangio First for wondering you've came on sort from

Steve Hoerter

Kennen. Steve. Thanks, Yeah. It's

respect to on syndrome. the first ASH So presentation differentiation with

what with information manage should to sales you there FDA for how are really best or seen TIBSOVO respect TIBSOVO, whether and exactly our educate presented teams, DS. accordingly, syndrome, respect may with our what to to differentiation since is events any As or in physicians it's know, associated that weren't then important is the an with continued label adverse presented. haven't And great surprises data so it launch MSL the the teams, just detect teams our data new on and This any impact we've since to was occur. we so ASH

Chris Bowden

Okay. Kennen, here. it's Chris

X.X. So the XX% detect CLARITY to ratio study of power a hazard has

Our of assumption three months, is months. of in order control for survival arm, the progression-free the - couple two to

Kennen MacKay

Thanks That's it. much. so

Operator

Thank you.

Our next SunTrust. Peter question with from comes Lawson

Your is open. line

Peter Lawson

Hi. Thanks my questions. for taking

Just additional maybe question versus EUX? force go around, thoughts in I to the products Jackie, just decision a and build thoughts for with buy that guess, the for macro sales alone around

Jackie Fouse

the Yeah. and for Hi, welcome for Peter. question thanks Kennen Thanks well. the as

So, broader it's have the a already got the of is position and which at owned. you we of they one strength products, got deeper look are and in development that portfolio a clinical optionality there's approved pipeline number the lot we wholly potentially in we've the products in two ever indications today, been. play can of and is of that than a When and terrific that we've

came near the I a little we might color in today we for at to countries in of when that going is on our But So, evolution go. more to of over minute the portfolio on decision. as the term European own the look a selected time well opportunity, the to opportunity EU Andrew turn it conclusion way in number just we the have over what the as for

the through of for product very we've late a early got or XXX discovery research are last the our team I've terms bring a going We IND In candidates pipeline. said, humans, and buy those engine. lot on. as productive a priorities been and the are to mean, I that filed support the continue it's just into team year now to priorities for moving to build decision. The

So we want to resource that. to continue

keep long-term we teams, to have organic this our performance capabilities along clinical we and commercial our as execution as clinical those with We've fast building So stellar driving want up, can. And we're got across now. we move growth. programs those that

So want complementary lot a could future But have going Those position we as have. to or if are lot you from on, a the don't time I appropriate. decision you that take about kinds strength other be say of we in see whether physician a just that we're potential to Andrew, them. great quickly? today, something Also know of over what do we’re things we are the in to want that adjacent, are. there EU the just and with where a we'll moments

Andrew Hirsch

Yeah.

year both And made as the sense went deliberate in over as to broad sort end the as back, of for future most rest and of evaluating the ourselves. we our included the our commercialization launches of structures. as ourselves multiple proposals see a platform. thought the of process the day, interest at deal see through partnering, assets thought strong step we last of as So value, portfolio. of as did maximize that really well our variety in TIBSOVO, commercializing process pretty both potential we the and building well the options we But in a of did that course but we We - TIBSOVO, about also

came we so that through And process. we went where down as that's really

Peter Lawson

for you. trending? can you for there on a Thank Steve And for know days Chris, around that's early treatment? any it's just question you. maybe duration but TIBSOVO, or Thank I IDHIFA, how duration comments make of

Steve Hoerter

Yeah. Thanks, question. Peter. Thanks for the

on I us pretty consistent and a to we clinical the early we TIBSOVO, be we to saw with see duration comment respect going fully to on what So setting. on trial with mean, duration. on still expect it's for that what little IDHIFA

January, we with is now we in over As months, duration IDHIFA on four trial setting. what approximately of months, the four at spoke in see about JPMorgan again we've just consistent which seen

the see But trial expect range a the to see to nudge continue refractory particularly we'll and think higher. of we're relapse clinical bit that the would what based setting, experience. I in we in on

Peter Lawson

Thanks questions. Great. the much. Thanks taking for so

Steve Hoerter

You bet.

Operator

Thank you.

question Our with from Rama Anupam comes next JPMorgan.

Your open. line is

Anupam Rama

for I are much about activities what here? for some so Europe ongoing for Thanks sort about you to at you talk EU this of soon. little And now are the region? then bit the a said question. so pre-commercial conference that weeks taking sufficient guys. of guidance timelines through steps can And being ago? Hey, coming the couple quick a the the the the questions Can day concurrently, XXX commercialization Thanks for think are and cash now next that question you just appears in from unchanged XXXX, position, TIBSOVO confirm be a least this activities? Because includes of much. TIBSOVO

Jackie Fouse

the either Andrew Jackie. terms I'm jump see and in make and other probably the But regulator. then that the we in just going let And It's process. as comment invest gate to will is way process that the start that that. - what If carefully on we but when through than with take our very we want invest in, over to to don't we we in to me. way to our we we after in start remarks, said make with we Yes. can Europe say we are we Chris in, the plans line the of the about a Steve MAA milestones in or through as lot going regulatory have

expectations the as go through details with details product. start plan share about what approval of you with will line way we but timing respect our we the see, specifics the that going make the yet, not in into of for just we're of we commercial to So to potential to I don't that - with the more

Andrew Hirsch

does Yeah, runway the Andrew - runway for kind runway. the of your the the time guidance question is over European this build around so period. include Anupam, And

Anupam Rama

Thanks taking questions. Great. for my

Operator

Thank you.

with comes Our next Citi. Bansal question Mohit from

Your line open. is

Mohit Bansal

taking think for Maybe end opportunity the Jackie Thanks the as question the and of opportunity cholangiocarcinoma to the well. in infrastructure that and that the of may Thanks, on my Great. - it's be you little be delve for you. And versus that commercial Chris. if opportunity terms there? about trend there? could congratulations my may Chris size you bit needed Yeah. would needed launch from Mohit, v how Thank A Bowden

I'll take of the I question first your two parts think there.

So with X,XXX respect are to in believe the X,XXX patients and the each size the of that and the of and opportunity, IDHX We have Europe about, year about those as talked XX,XXX US mutation. patients are estimate in we diagnosed between previously we disclosed there that the disease. with

that's US And it of the in size we We to now expand. between would to Europe. the of whether infrastructure and that's to kind the believe So evenly need pretty a when US commercial significantly launch opportunity. split comes and support

course think be launch. in closer a to guided more have that we a we'll need of you doing range modest we'll our of to as to FTEs. further this that refine of the to that's that organization, previously XX we've we work share we But assumption would expansion what the get Now some sales and year with potential to during is, on XX

Mohit Bansal

Thank Helpful. you. Got it.

Chris Bowden

You're welcome.

Operator

you. Thank

Chris Shibutani from question next comes Cowen. with Our

Your line open. is

Chris Shibutani

would the you we of debate appropriate to regimens we exactly clarify became going much. consternation of be everyone came seeing are comparing a or In will be know what we data. perhaps bit with a later this to see Chris. ASH? think Thank feel Could additional way what us for source you incremental some data and that this very Munich competitive month question about when just a other out you you that for that Perhaps, in let the Thanks. of

Chris Bowden

Yeah.

So at study published Phase plus the the TIBSOVO I/II data last combination ASCO for azacitidine from year. we ongoing this

going with with are combination to you're dataset XX up. treated that see So a with follow longer who patients

terms will rates, and is rate, what's response as in overall make the duration, with what So how are, molecular allow to conclusions well clone. dry responses one understand insights to importantly regards to data CR durable some as further IDH that to happening of do

course be very last that safety. I of think So piece will is then the and important

this context exciting of think which So the this very and will very patients reinforce active saying and number what emerging combination. we this that the have new tolerated been a of will time is and in underscore with drug, of for we we've be placing in makes a well think helpful, terms it I AML, really

And so it looks be for option going are like mutation. IDHX very who good to patients who an a have IC-ineligible, it's

Chris Shibutani

Great, welcome. since Bristol folks upcoming at implications opportunity commercial about your Have thinking combination the and business had far interact your to how any with Jackie, announcement? that's as helpful. and/or about And you that obviously outlook you're Celgene any their planning? And thoughts about as Thanks.

Jackie Fouse

time. So, interactions I mean, the I all have ongoing with industry people the across

to so deal between specifically guys. it's And the related those not

see and that. closed deal what their happens get them after let let's So

to. we work with have Celgene of partner, as valued the that would and We in all a way we is past have same to going extremely continue as well the it that in and expected

well anything in this on and let's wish situation for go. sorts all, Agios say, So not can't there better I them we situations. at of so and see these negative the comment you

Chris Shibutani

Great. very Thanks much.

Operator

you. Thank

from Newman comes John question with next Canaccord. Our

Your line is open.

John Newman

combination? for my promote off-label Jackie. that this data that immeasurable doctors combination Hi after to there, in and of taking would never way, me at good morning. from do X+X use look be is, think as get I, you Question might obviously, AML, the Phase there a but Thanks. Thanks you question, welcome well

Steve Hoerter

the John. It's Thanks question. for Hi, Steve. Yeah.

what approved within You're right, promote we only label. FDA the is

- take with to I data their from or choose own or think as patients. trials is an physicians the that Phase I/II with case with not any experiment need, disease significant where interpret there unmet and may choose will not is

guidelines. their As to in it comes treatment their be data and and you that to emerging know, as recognize NCCN out compendium use quick pretty accommodates tends in

the new I'd in who say given just the And options. is dynamic AML decisions patients future broad news and for exciting on of we exactly is space treat physicians ensure the view great that, these the inform right and I has focused a time program an patients combinations care. very data with Chris think, standard this our number that generate part of it's is to what as this to the we to for And doing. that's role evolve treatment our right is of said,

John Newman

you. Thank Great.

Operator

Thank you.

Our Jaffray. Duncan with Alex next from question Piper comes

is line Your open.

Alex Duncan

types another year PFS do some be Hi. in first CLARITY, rates a TIBSOVO on And outcomes later care that's because, question. then general of is in to I'm testing just by eventually I'm or guide or this genetic year I'm MTAP. to final for in testing on of in could file and to data frontline at this in these results they enrollment? sNDA cholangio successful to And used deleted Thank justify year. promotion and similar is is questions, MTAP, this be wondering later to how outcomes patient And the testing have which the trials benchmark you line year are you these TIBSOVO analysis you to specific standard forward? tumor worse? enrolling? regards allow package on just and will here? common to And these wondering the analysis bias HX what you in later curious plan being and instead rates in do cholangio Thanks are population the I'm potentially are the MTAP to needed with genetic wondering, all of There if Two cholangio, paths current move And this do the patients of top PFS. tumor year the this that to With And for And followed can package filing allow met need is this needed filed you're reported in across final and to the end sNDA you. the the HX indications? current be in on the in certain this? question

Chris Bowden

secondary here. and important your around of progression-free and Okay. with survival. It's And survival of Chris the aspect endpoint CLARITY to design questions the regards overall

to be is, presented half the data to top of the and year. trial going the the of half in we're to first second the submit the results year what data So at in and the we of meeting from announce then the do plan line

when see study. So the results expect the the from half second year it's in one detailed to a could of

endpoint and is secondary endpoints I positive think as as progression be you being has crossover. trial will well supportive. primary of Overall meeting, predicated I remind that can a its free the that survival. important survival other on trial

at patients no for of the are coming component know available So, study there status the and offered there because thought time of into progression was the crossover, them. trial patients important are other a that an IDH therapies we

but at, one mean have that need not approval. need isn't we consider persuasive doesn't to look study in that setting So that a overall wanted positive that would garner something the would and survival to of we survival to

don't at within an with for data debated to a do something and free we We with and totality regards MTAP-deletion of they what's very of course, an various understanding questions. had With world does matter be that, have MTAP, progression the throughout the at patients to rates outcomes? that have testing say look Of around as with MTAP-deletion. response the captured needs three survival in in for data. around, is the group rates, little that of point. rate discussed or - indication selected to would you that's authorities of this testing I the Testing survival One data - probably regards the I any there's terms

very alluded also a like which education not with diagnostic. but up important to, its end with we will you a along of development, in we this part companion MTAP of that CDKXNA a TIBSOVO some However, where routine we the continues P-XX, is physician to if be just and testing developed Certainly, drug the is panels [ph] that. do, tends what to might move part of travel which

Alex Duncan

much. Thanks Great. so

Operator

comes Thank Instructions] question from Breidenbach Our you. Mark [Operator next with Oppenheimer.

is line open. Your

Mark Breidenbach

good Hey, for taking the morning and thanks question.

a you're wondering, mitapivat. better of Thank Just the efficacy, I'm the expecting and better diversity PKD type with or program mutational cause one population. can wondering you. as quick me hemoglobin mutations others? in versus in on given this the backgrounds PKD I'm of from Basically, response stratifying some trials mutation how that

Chris Bowden

be predictive Chris or the makes is genotype mutation. to understand of fascinating developing on which the missense to them with based of non-missense-non-missense, on There hence trying which fall the and question, way look - have that where about non-missense. least is here. have mutations from potentially that mitapivat. then how think described. response with your We into eligible at when your nature to this dry Thank if They we're this And category, question missense-missense, it's a to I at in this And have are over response genotype for of PK, a tend missense, think, that categories, - is mitapivat. there's been data generated So, - of one you XX% XXX disease. we component patients drug we've

to from don't we perspective. a we position. a that good in need a thing, different at if when it had That's because consider genes, look to XXX So pretty be we challenging would you stratify

from trial. that's patients aspects the into the gene come we non-missense-non-missense dry based with on some So how and we've trial designed that PK, category the a of learn don't

really in need address the aspect studies is we pivotal ACTIVATE, of that randomized our So trial in stratification takes indication. care which portfolio would that this of any within to

Mark Breidenbach

right. All clarifying for that for perfect. me. That's Thanks

Operator

Thank further back Jackie remarks. you. At closing call turn showing like I'd And currently the Fouse no to for to I'm this questions. over time,

Jackie Fouse

joining XXXX going terrific us Thanks you, We're an We've ever to to on execution we've for today. portfolio to going the across operator. continue those. for than is It's before. Thank for a of stellar programs year had year everybody deeper be broader, us. us. ensure important got call

we'll from the data the be commercialization going outside And see of the course for we'll our We’re flow first TIBSOVO year and over US. full a starting our plans nice to have revenues of year.

all to So more employees come. dedication, Agios there on, patients team I do. And participate because and clinical what like we do to in without caregivers not we'll thank physicians see and soon. our also them you lot is thank a Thank just serve. the who would and to we for of for passion trials, I here our tremendous you the could want their at patients, we the going that

Operator

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

Agios Pharmaceuticals (AGIO) 14 Feb 192018 Q4 Earnings call transcript