AGIO - Earnings call transcript Q2 2019 | Agios Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Agios’ Second Quarter 2019 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, Vice President, External Communication and Investor Relations.

Kendra Adams

operator. you, Thank and call. everyone, Agios’ quarter second Good welcome conference XXXX morning, to

You going today’s section for can slides access by website, of agios.com. to our Investors the

Chief are With Senior updates. business Vice-President review Miles, our summarize Bowden, Officer, commercial Jackie Financial call U.S. second performance clinical Q&A. Andrew on Medical Chris be who today of Chief will me Marketing Fouse, review Commercial the results. Chief will Dr. our Global available Hirsch, our our who Officer, financial Officer Executive our XXXX will key development Officer, will who Darrin Biller, Dr. highlight Chief our and quarter our for Scott will and Dr. Scientific progress, also

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

subsequent any In or We views be update today any call and views specifically forward-looking relied our to made should disclaim statements. obligation revise upon represent addition, date. any only on of this as not statements any our as of forward-looking as representing

I’ll Jackie. that, With the call turn to over

Jackie Fouse

us call. XXXX results Good morning, on for everyone, our Kendra. and QX, joining Thanks, thanks financial

research, you so goals team clinical the ambitious far set incredibly progress made today. year our update our our on of and across and this proud the the I’m beginning of achievements At we XXXX of out several year, commercial has we'll activities for

quarter, our all broadening well focus advancing disease our second steady mitapivat clinical areas MATXA a In portfolios. AG-XXX business, driving maintaining and drive we across the program. value expanding executed that across the potential XXXX are priorities development our opportunity, on and we market inhibitor addition, rare commercial performance, oncology have the remaining to In genetic the of TIBSOVO

AML provided more with to in approval later Darrin the trajectory launch will additional frontline April and Starting on levels momentum. the in and relapsed our commercial May provide TIBSOVO expected call. details the performance refractory returned

the TIBSOVO On side, in we at azacitidine. frontline potential ASCO that and AML combination with the clinical IDHX of agent presented non-intensive EHA both setting data the impressive mutant a reiterated single in as and

of cholangiocarcinoma progression compared announced Phase trial primary its In endpoint of the met or May, ClarIDHy improvement free X median later we second survival in line placebo. to

demonstrated clinically results more later data next significant challenging this patients The to share about month a and TIBSOVO plans will supplemental disease. present this the our benefit year. And submit Chris NDA full with and of

completion discuss earlier begin progress phase also to will ongoing the Chris including stage of dose on the expansion finding trials and of Phase work AG-XXX trial. our plan X the our

Related to capabilities. global of business the our evolution

as medical geographies is strategy international. the senior have and building has our the manager commercial that We Oliveira of the with and outside EU formulation teams, activities now U.S. for gained the and an hiring vice European of process begun our EU. of the and momentum leading build Orlando Orlando recent effort president general

value in been and broad company been the for XX research long focusing made creation on execution clinical our our the better understand preclinical I've strong capitalize start, our making XXXX my platform has unique years. optionality to first my where and evaluating the I've efforts. I'm business its that addition portfolios in To term successful potential. often also to ensuring about am objectives, priorities we In that progress asked on and our corporate I the

to solid both necessary the tumor sustainable capabilities aren't and that we focused core also in currently market. capabilities that but our building our yet our solidifying Europe, I'm either don't or are to These have include, biopharmaceutical include malignant a on mature enter become hematology in team non-malignant company. establishing that readiness ensuring And and and

I pipelines in best across indications significant genetic continue size, one that for optionality we our of both compounds believe oncology have to in and the diseases. the and industry rare multiple and

Chris I'm that, excited look our continuing you. to we're also we and I'll regulatory update. clinical about over not And where turn with but share only are the I progress With going. to to where our call today, forward to provide

Chris Bowden

our refractory standard-of-care monotherapy regimen clinical in disease. TIBSOVO to development in program with Strategy in a secure the where Development Jackie. Thanks, labels with and I'll relapsed newly patients setting start and Global for broad AML, we're with advancing combination diagnosed

TIBSOVO EU, a we are XXXX. for and end MAA half second and receive submitted of the anticipated questions refractory of opinion the the at clock day CHMP the Based XXX we relapsed on to XXXX. on AML the the target in stop, In

with IDH of to rates response the of remission. IDH cornerstone AML with have treatment of an goals of inhibitors we continues of role and mutation driver evolve and AML, a in for patients remission clearance critical achieving frontline treatment will improving the become responding patients, is play In the landscape longer mutation, the with early in majority mutation. the demonstrated quality Since the higher

population which patients an trial. the labels cohort diagnosed chemotherapy, Our subset are is current Phase than in studied for for front intensive of who X important a diagnosed patient we of broader newly newly our ineligible line

rate XX%. study TIBSOVO presented Phase longer we increased XX% ASCO, -- data updated rate CR with from up the that combining to the to follow X showed increased CRH with At and CR

patients In IDHX from IDHX a data X trial this and to new mutant addition, direct of mutation of combination. azacitidine. of minimal durability treatment this to year, patients speaks of in This the clearance residual disease we ongoing and expect the Phase TIBSIVO CR response suggesting biology present achieved important plus the with who AML. At impact mutation clearance on majority later ASH on also had of the depth

which patients. is X further This being in combination Agile explored is enrolling the Phase trial

intensive combining with IDHIFA can who groups cooperative and X+X tolerate Phase their patients depending cooperative patients chemotherapy, on are or the AMLSG dosing HOVON now TIBSOVO the X IDH those mutation. in a For trial

we In support novel shared combining her Anderson AML. to but study and MD combinations at Courtney EHA. data in investigator novel early of sponsored venetoclax DiNardo continue TIBSOVO from IST explore impressive to addition, Dr.

Mostly response patients in overall this and compelling AML the had of study of a were relapsed and XX%. of rate rates XX% CRCRH response CR refractory rate an with rate XX%

patients disease achieved In addition, by cytometry. XX% MRD-negative responding residual or were flow minimal of

triplet currently Dr. is a is combination DiNardo of patients. exploring TIBSOVO enrolling Venetoclax which also and VIDAZA,

of malignancies, with the we of study of X hematologic filing the pursue Beyond process the in generating and reopening regulatory in Phase the this syndrome AML, indication. TIBSOVO data goal in to are sufficient myelodysplastic arm a

Phase progression the compared is that placebo. previously Moving tumors, we to solid free clinical of example treated setting. in agent mutant in with carcinoma calendula endpoint of advanced tumor announced X TIBSOVO This in benefit the of survival differentiation study primary solid prolonged met IDHX a evidence of May ClarIDHy the first its showing

and there carcinoma patients Calendula of occur the treatment ducts the a within limited, options carcinoma rare and Current are thousand in calendula mutations liver, to is and bile three cancer therapies. the two EU. in outside and approximately approved U.S. annually systemic are no of IDHI

survival study the set data at full from overall the submitted have interim including ClarIDHy presentation for in We fall. the

and therapy the the of the this setting. submit on for are the the TIBSOVO targeted first have SNDA end to year to by We potential be in track

Finally, input end the FDA from and we low IDH X EMA Phase now vorasidenib the and points have mutant on study glioma. for grade

updating initiate on the you track trial to incorporating our design plan and clinical this trial We feedback into end on the are are closer We forward year. initiation. of to to the look by the

now to opportunity patients to our we're significant progress benefit. who review activator broadly genetic program, disease I'll making have rare the our expanding PKR toward the for where potential

Our to ACTIVATE for and is with mitapivat kinase pyruvate enrollment complete on year. this pivotal in program T later and deficiency track remain advancing ACTIVATE adults

finding not on efforts trial. enrollment successful XX based in been enroll and up have as last for patient to has increased patients quarter interests we T shared to been ACTIVATE the Our

the We pyruvate from three years profile hemoglobin the than peak where for some with natural deficiency. history also allowed profile. kinase from submitted comorbidities to new ASH better as us DRIVE have the abstract the understanding well disease study in are term registry. as extension safety better PK adults data the and phase have including patients an maintaining presentation at more we've increasing and study study treatment And comorbidity through mitapivat natural the to at from now understand the to findings for Data potential on with of aimed and data submitted complications mitapivat been has been of long better of history understand the continuing the This ASH.

activating that know addition pyruvate our ATP we deficiency, In in results healthy trial, levels. type increase in from X to Phase volunteers PKR kinase an wild

in impact so have we patients, So on doing believe thalassemia we by can that that disease. an

label we the year. the endpoint to open of and patients, thalassemia deciliter, grams study initiated proof-of-concept we per than is with and in X less Earlier end response. to an enroll expect Phase hemoglobin approximately trial this primary year, X continues This achieve hemoglobin by XX the

is sickle working Lastly, and disease, with there on patients. enrolling study for benefit potential Health initiated where is the for activator clinical we've of mitapivat trial patients. these PKR been provide National to The cell and the Institutes recently of

and AG-XXX programs MATXA inhibitor. our I'll inhibitor stage with close earlier AG-XXX, our our DHODH

Phase X single the quarter, trial agent selected forward to dose second AG-XXX finding dose. work the and During the completed in we go

we studied of total, across types. approximately a patients wide AG-XXX In variety tumor in XX

molecular portion in data the at pharmacodynamic place in the Conference be on safety, the AG-XXX and of pharmacokinetics therapeutics the will for of targets AACR-NCI-EORTC to October. The submitted data. study X efficacy addition this in cancer focus International have of presentation taking from presentation late We Phase

downstream inhibition namely reductions MATXA markers biopsies. SAM our pharmacodynamic of interest, particular Of and of in tumor data

advancing we we the AG-XXX of taxane with areas phase of preclinical this year are earlier two at will unmet to based in compelling the high presented now in on evaluate next development AACR. data where combination We need

another the of and study test in cancer ductal will combination in MTAP-deleted MTSAP-deleted One will nab-paclitaxel with AG-XXX lung cell docetaxel with in arm AG-XXX pancreatic adenocarcinoma. in and arm test non-small gemcitabine combination

upto arm combination patients. XX enroll will Each

in Given PD population. data we safety of determined already basket patient that have X additional study amount need we collected, don't and Phase a have agent PK and the single a data we

less a more progress heavily and may plan, we decide agent to single pre-treated as populations. development in homogenous patient overall explore As our AG-XXX we

clinical encouraged demonstrate Deleted with triple We by to tumors be the look that to help continue sharing meeting we the forward clinical and the and pre-clinical October. AG-XXX the potential for to at patients in data MTAP work

in patient study Phase progresses. in update will DHODH at X the the I June, as we you the AG-XXX and our trial our Finally inhibitor dosed first

activities. the commercial now review I'll our Darrin turn to call over to

Darrin Miles

two on to refractory I’m performance. focused doing U.S. TIBSOVO commercial or in launch AML execution to the call AML. TIBSOVO priorities, happy to In the quarter of today helping launches our continued Thanks, team first my the relapsed conducting on ML the second outstanding Chris. an and just join role, new second, of our The months. discuss is in XX successful two recent approval job frontline launch I ensure

visiting in and of of in is lot time engagement a the spent I level field witnessing performance. I’m with reflected physicians our the

Now from with increase XX% revenue quarter. results, second TIBSOVO a $XX.X our net quarter to was the respect first million representing

to As following the we quarter, exiting launch the through strong call, quarter. saw in trajectory we growth mentioned impact team QX seasonal the first the and our into that returning QX on quarter continued unit first saw the expected

the that strong in IDH double digit becoming now range, setting seen the with XX% academic both physicians TIBSOVO. familiar and reached growth we’ve Importantly, testing are has the more community

FDA Now QX physicians. prescribers and among unique academic one approval, since base prescriber and we’ve surpassed our both up continue community XX% since XXX broaden to year

led quarter. line which second even approval in front in early of latter The May, driver more to of was the the momentum growth part the an

or or educate for syndrome IDHX eligible known team for positive concerned the those newly frontline feedback previously HMA an approval who agents intensive therapy. as disorder indicated patients with older for still regarding those who that Our Overall, as AML continues about and about from been physician to use our early hematologic use we've has in is physicians patients to or were treatment hypomethylating HMAs exposed diagnosed not mutant heard positions of those such HMAs associated were the toxicities combinations. antecedent myelodysplastic largely

success I'm also diagnosed in of date, improvement physician I seeing and using in meaningful our commercial inhibitor our have patients. you to forward molecularly by updating confidence a to continue pleased especially ability IDH on look treatments, belief in to We're calls. I newly progress an extremely future targeted TIBSIVO. the

I over turn will call discuss to quarter to now our the Andrew second financials.

Andrew Hirsch

Darrin. Thanks,

detail revenue, which net will today. for issued sales we be IDHIFA which million, revenue. Total second press was dollars million summarize. $XX.X I'll release quarter collaboration Our million in million of included later second quarter $X.X XX-Q $X.X be and results consisted of of in TIBSIVO, of can filing this the royalty the found $XX.X revenue More morning, of U.S. our

$XX.X to of $XX reduction Revenue million XXXX decreased through the million from by QX, $XX.X XXXX. $XX Celgene a recognition million, QX, compared which driven CStone of the by in of signing from revenue milestone was in the and a collaboration collaboration million

throughout the the quarter consistent increase remain by $XX.X demand. sales a was saw TIBSIVO from we and on offset inventory levels where but an in of U.S. of IDHIFA for week million was net relatively royalty $X.X sales of hand TIBSIVO quarter ended an we level revenue with increased QX, of This basis flat units increase $XXX,XXX. the in on Cost million. absolute

costs R&D Phase increase The origin startup related in expenses, in a operating the deficiency period driven thalassemia, to PK increases from of compared vorasidenib year-over-year million lymphoma payment to our largely and and for $XX.X platform activity to quarter X second mitapivat million, [ph] the of R&D was glioma. to in Clinical increase and by low costs of clinical Phase research and $XXX including and trial trial the AG-XXX study XXXX. X the study grade milestone an for same was Turning programs. planned

capabilities. were Selling, increased a increase expenses and general second by million $X.X and driven the administrative in XXXX, quarter, quarter our representing infrastructure over commercial investment million $XX.X for

million. marketable We equivalents ended and $XXX cash, cash of the securities quarter with

cash this expected anticipated but will the to for payments, plans end fund XXXX. excluding specific our at revenue addition balance current that product milestone in royalties, expect and operating of We program least

that With the operator, please questions. open for line

Operator

Instructions] Thank you.[Operator

Andrew Hirsch

the to to the questions, my decrease mentioned I The R&D XXXX. from we XXXX XXXX in before incorrect. was just correct mistakenly for QX, expense. from from million correct QX, of revenue change XXXX in take to QX, wanted $XX.X number increase Operator, used number remarks. I something a QX, The prepared is I

You open now. you. for can the line Thank questions

Operator

Thank you.

JPMorgan. will question Rama with first Our come Anupam from

Anupam Rama

question, What really of XXXX. progress. prescribers XQ the are significant thanks XQ question that on in Hey had and unique prescribers? for much. pretty the guys, and XX% taking Thanks the that the a increase unique between on congrats and quick drove I all so increase factors

Darrin Miles

prescribing community the those physicians of and we physicians. Anupam, saw was this have who between prescribing is TIBSIVO the increase The These IDHIFA for even and first hadn't been Darrin are that here. academic mix both previously time, who were prescribed as well.

or So various types uptake we're getting amongst penetration of physicians.

Anupam Rama

my questions. so Thanks taking Great. for much

Operator

Thank you.

Our next comes SunTrust. question Lawson Peter from

Peter Lawson

be quarter? combination kind Just versus off a net growth, that questions. helpful. both for And whether or you next and can TIBSIVO other we gross potential Any follow around provide the be kind of for label then it's up inventory use think around on-label would of should thinking you and quarter this color to

Darrin Miles

Peter, here it's Darrin again.

continuation we through saw of That As carried the was a QX. I driven relapsed latter remarks focused adoption half that the the continued in we largely by improve in that the in the quarter AML my second QX refractory setting. growth of mentioned is saw or earlier, momentum

fairly saw of any just then but minimal. state following it's unapproved the we monotherapy or some for that further off-label said, growth promote frontline uses adoption is have don't acceleration approval. We to unapproved while That of spontaneous we that do important uses, TIBSIVO, that

Andrew Hirsch

And to and it’s Andrew. gross I’ll take net the question. inventory

first on So, inventory.

year, continue numbers. are that – as with mentioned demand I we through stable a that they since would remained increase much. expect hand will increases. give on want too them, don't specific and our stack and out that we as we week’s So to the of on Absolutely basis, the we increase. don't levels But relatively rest inventory Obviously our sure again, to make up

through, Clearly, For really still a that's to Medicare been in down it's within range mid-teens. mid-teens but worked an as fluctuates. in gross given has QX, net, and the saw saw that but we what our hole come donut in guidance clearly of rebate, obviously little we that bit, increase the

Peter Lawson

much MTAP Great. when around combination Thank we'd see the the triple study anything And potentially just you. efficacy side? can XXX? see we us how And then you data on could meeting, data tell then, the for at on

Chris Bowden

early Chris combination running. our main goal comment data, Bowden in to around to up to is Too provide the it’s here. on expansions Hi, get guidance now those

come to on and more major could later So when read that out medical be a meeting. at presented

comprehensive at and With see of regards be meeting will to presenting a we what will data, the we safety, be efficacy, -- what pharmacodynamics will what single you the agent pharmacokinetics. expansion and view triple

phase who sense treated a get our that of patients experience are in you'll the good So in of trial. those

Peter Lawson

Got you.

much. Thanks so thanks the Okay, questions. taking for

Operator

Thank you.

comes with Shibutani Cowen. question Chris next from Our

Chris Shibutani

you were statement about in the doing that Good about making much. not how you said think that morning, what combinations? single the work terms for conclusions, The thank can And basket you level think you're needing your about AG-XXX look work about we to that dosing of you data. taking I of right confidence additional draw if dose very kind made agent about selection, about we previously any can into sure

Chris Bowden

Chris Bowden here.

I now good chemotherapy, we portion the So dose my about think cytotoxic it in escalation that have single after now agents the prepared with remarks. agent with completing talked I that to combine feel a

have combining for now we with. to always with drug preclinical that think that and drugs for that what combination portions. you place there's drugs those And been account how strong taxanes. a side that's we've and a that most start effect And you're potential pretty with this rationale in we other in ahead think, proceed to is with talking of think then go about we're overall, of so, I when for course combine, But combining you the profile the good

agent part to fundamental -- key combination dose whole that escalation that -- real therapy. the are that of this single of whole prepare for So expansion component was

move we we need So think now have we what forward. to

Chris Shibutani

and the of of talked the the side. of patients, future? duration think about earlier duration you the as what and sort then to the into Can use Great, you we you're line what the are, just trends go into past expansion I label relapsed refractory, for commercial with potential outlook to of comment potentially that for of shifting the over in both there's use that from terms on imagine continuing in In would those seeing you other through Thanks. usage, increase. the

Darrin Miles

this is Chris, Darrin. Absolutely

that in duration, think, to about approval. we the I since improvement stated see So we've months. at is steady four continue before Duration now

that We X expect what X reflects IDHIFA. which month both we're experience seeing and settle to the it will with ultimately around about the point, clinical

future frontline combination reasonably with the labels in further. in That particularly said, setting treatments the duration could center-of-care extend

Chris Shibutani

see Great. on great track. Thanks, the to it's business back

Darrin Miles

Thank you.

Operator

you. Thank

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

Kennen MacKay

for From AG-XXX? didn't data to Thank meeting that the XX mean understand be from and we type. And a combination? trying my what taking progress there. quarter. you. as I thanks from see and there how without each combination couple what commentary can congrats on I'm real single of populations Chris. just of see on expansions your control, you're the that and chemotherapy presented just defining hoping that, be understand XX, triple questions Deleted how to mention respective Does to to guess, tumour won't or would and Hi, up follow then a I with MTAP data the without help response question the agent commercial tumor us and the do for Maybe guess do to this arms this you data what expect responses you with weren't interpreted

Chris Bowden

Yes.

triple the efficacy, going Kennen data safety, regards from pharmacokinetics pharmacodynamics. for with meeting, provide dose escalation So, and we're so the to to

demographics of patients pretty safety see a diagnoses. are the range presentation to standard we you'll from think heavily Phase efficacy a who I this of dose as treated toxicities, limiting this were able in record So to X group across different

will be that So there.

which second data that is you to control. the and combinations, regards of how part a interpret your of with question, in Now absence the your

together, – you up to drug is, the tumor combine once can a to demonstrate questioner want able with really and -- give part of you come first multiple previous regimen. these The tolerable able cycles important that be drugs we component, that's assuming we're that a induce are because treatment to active we to responses is and

pretty past you duration trials X can Now, without any caveat. have efficacy overall number carry as of Phase have good setting, in both where response. that a the there of response, over control that years several you been data, of you a and to look Phase sense on a Nonetheless, X the always get

look And be so will we'll important benchmarks those at. historical

then some and with need the of think with that we'll part there have to that MTAP deletions this about -- significance. interesting associated the also is fact other are may deletions And that these XX prognostic

take what and good and you've sense data we've won't very two forward. So that caveat it's sets very we’ll think to a the development. the of at and reasonable pretty of these I a preparing next stage we’ll able completed efficacy a that tolerability judgments be no be would to doubt, some have for of the make But highlighted. expansion useful look and – historical have terms think safety around And good I cohorts, to in the regimen able

Kennen MacKay

Got of of it. dose terms study. escalation slide on MTAP I confused the the just the goals Thanks. was in

them, and are it is tough enroll. maybe to population faster there's sort pace that and in pharmacokinetics of understand the the and there, the these than the enrolling quick follow it, T exist didn’t the wondering they not are the is but ACTIVATE I maybe appreciate for I so we expect up you clinics, but other, trial. trials, sort seems are a where said them could had Maybe nothing independent maybe in that out ACTIVATE of if at You like was just a available help pharmacodynamics, since if a just on transition one patients us the color. of

appreciate any And be I it. would Just color huge? Thanks so there much.

Darrin Miles

under could therapies of diagnosed, Well, because we think of approved. the available is lack overall nothing's therapy be and disease the

the the what not patients not not word there's but they're not therapy looking out and sure know supportive do care. physicians I'm may and than you then be is, some aware right something other transfusions disease is and with for to the nothing of other of there so approved, And is, much

And we'll according the accrual anticipate we to that the schedule, accruing end the complete of are trials and year. overall by

think other, than I provide one package, faster this and would never really because trials some move the went if we that was, a of and we that sort the them we them regulatory question your see patients and other at is advantage non-transfusion of never, that on at we say look dependent but dependent as we together. part a as disease individual transfusion -- think at spectrum of the But disease. look look we would

lines possibilities, So those we're but at point. along getting there not this certainly anything

Operator

you. Thank

Our next comes Goldman with Richter from Sachs. Salveen question

Unidentified Analyst

Great, one is Salveen. for for on first taking My our Andrea thanks questions. Darrin. This

possibly If frontline TIBSIVO the sales? could you patients the to at AML comment contribution the on

Darrin Miles

Absolutely, Andrea.

the using May. as monotherapy So say that in early and I performance we’re frontline the approval I extremely in mentioned quarter. remarks, will was for first by the the my only initial pleased setting

But And in early. days absolutely relatively quarter. here, early so in we're we a contribution know performance the it's made to still so

in Now we have with to on the TIBSIVO by we previous I utilization visibility into line treatment. relapsed utilization of risk by limited regard refractory, frontline line of calls the shared versus of think

coming much the other that those from, tell you just of is from versus front I in line how can't setting. use So

Unidentified Analyst

indication? transition comments cholangiocarcinoma but ongoing be the what force any to on that preparations are And any efforts for early to as changes Got I it. it the second still solid you might And have sales necessary Thanks you you do might think tumors? much. then so education is a pre-launch question, recognize

Darrin Miles

so patient It’s fair incremental amount is good in efforts Andrea. question. the focus pre-filing team of disease AML in actually phase in between efforts ramping up effort overlap is a There's which then to on disease in -- and the around education, this that's investments our physician The need actually – incremental that. order a the that fully Okay, required target here. the decreases accounts cholangiocarcinoma, address

modest to increase launch. expect order a modest make sales we to So, for the support don't in force the

Unidentified Analyst

Great. Thanks so much.

Operator

Thank you.

with comes Our next question Newman John from Canaccord.

John Newman

Thanks lot Hi taking a guys. my morning. question. Good for

we cholangio. versus the we smoother Just on AML? in and TIBSIVO saw be should how Thanks. the about is accessibility be thinking what IDH to for had testing bit potentially specific whether for another and one question expanded should My initial a launches the

Darrin Miles

John, So your this is here. question I'm understanding this is Darrin.

in does AML. of terms asking testing cholangio to for access about You're relative expect we how -- what

once of a have we'll a filing experience companion tests. is a you a sort for an So we companion lab diagnostic, that we same of common file, know which NGS But, products the we'll is with as have file, the simultaneous develop the approved most versus diagnostic test. adoption have of as mix FDA test,

So will broad. access expect should using testing that what will we ultimately up physicians should be be be end there be But their choice.

Jackie Fouse

Jackie. Hi John, it's

with market think TIBSIVO I for two that heightens think helps with need the of and you compete development that but these we also that, respective and there. the to know there's in another does cholangiocarcinoma company awareness cholangio, not whole overlap agent potentially a nor targeted coming test to also market that mutations with the

John Newman

Thank Right. you.

Operator

Thank you.

question Our Mohit comes Citi. Bansal from with next

Mohit Bansal

to my you thank be for supported these requirement? to cash broader how it seems it all on get by A to your and expenses with Jackie, balance reasons, question thoughts revenue. you just your might some questions. expenses desire taking morning, the expand time wanted Your Good the are for take right like increasing to but

So loosen here? to do I convince guess strings purse you the Thank question his you. is, Andrew how

Jackie Fouse

your question feeling Thanks, to neglected going little was Mohit. I for directly. not a

appreciate really me, that so know, it. I said to You do

we reinvestment we for the priority for So on those they that to with I And in to nice what in TIBSIVO patients portfolio respect very the we and create them and a create we're are starting ramp of can think our economic I well. for things see think in a going clearly lot for doing in. invest order shareholders we've and to the in expect value as that opportunity business that of the got

with I've a us I are along things think very so. to capital to we as utilization. bring continuously contributor been occasions that, our review a continue going a terrific on view do we'll to efficient and think, So helping number said that Andrew's we do how of And I to also continue being with to we do

Mohit Bansal

Got Thank you. it.

Operator

our from Michael next Schmidt question Thank you. And comes with Guggenheim.

Michael Schmidt

term good the I up development And you had on was then on you that frequency thought wondering was I to your of could question. looking just the did for and And may as mentioned, experience Hey, comment one if there on just progress. is it's I wondering most on IDH know but I near focus the the which you in trial maybe is think I comparable? follow you morning. likely be just around do whether the monotherapy Congrats mutation to mechanism, XX%. my the be believe thanks taking had AG-XXX ClarIDHy I cholangiocarcinoma. And could on… the types cohorts. focus on responsive be you based tumors on was AG-XXX. into say combination question

Darrin Miles

question in to overall, XX,XXX Okay, cholangio and We patients it's is cholangiocarcinoma. we regards the so there And about in around with think frequency the somewhere first U.S. the in XX% diagnosed think, range. the there to XX% of mutation. EU

selected the you of the in we cancer of a AG-XXX why of of the is as taxsanes reason whether both Deletion frequency to those showing of pancreatic the versus the that, use As early It's differential standard-of-care indications one has because cancer if of think those far we will. diseases. and higher the just question MTAP lung cell too say activity as probability non-small goes,

clinically the areas and issue, in high feasibility and pretty two are pragmatic a there's need. So

Michael Schmidt

remind just and of Thanks. the and MTAP Deletion And frequency can you in lung pancreatic? of us

Darrin Miles

numbers of can It's number as with we large with get a a about XX% We indications. XX%. to exact table a the to presented

Jackie Fouse

both can about rate and of you the both in to talked those, with the average tumor XX% slightly it's on XX think but that I they're XX%, occurrence. Yes, the we’ve slide closer XX we've what above frequency tops we or resend different there got

hugely was, the trial. I basket evaluated we be combo I was escalation additional us that be think utility the the monotherapy we of beneficial I the versus trial that on that decided not and to from clear, of just information think mean, doing just to have sort to that absolutely just trial. XXX, compared that And already to monotherapy another about the on question basket Chris dose going was information give going

meeting, and as in when population. trials would possibility data not see idea and think a targeted more we to expansion you, it some we leaving triple to will this you monotherapy monotherapy at or are you but will pretty the the clear evaluate a that data good whether that combo open to through these we do we all continue I even run work the the a learn work through, become as expansion And have, more be

see So would leaving in something that that, we're useful. tells open that we just case be us that

Michael Schmidt

Thanks for clarifying that.

Operator

you. Thank

Our with from comes Buren next Piper Jaffray. Tyler question Van

Tyler Van Buren

go wanted Good you you how or morning. -- think have specific think about stages and and the PKD. in development, per for are those? for do And cell. expand it guys. understand so I could the of you seem the see deciliter the on and -- landscape ask and appropriate later question the ability increase to hemoglobin a But thalassemia as with fairly type activation, the it's could we just some does you thanks expanding the eventually, confidence of expand Hey, in I Mitapivat, translate mechanism you competitive competing in with majority could mechanistically it's just see upon do gram patients wild that you of sickle that possible orals and

Darrin Miles

who range healthy volunteer across this activated Yes it's which a would study volunteers our for we PKR. type demonstrated the first normally really in -- XX part that wild and were interesting of drug developing demonstration Mitapivat, a doses treated days and with who of

because in of with the [ph] time whether like fundamental us and pyruvate internally scientists sickle also drug our interested thalassemia this could It help in cell of the have potential had the deficiency. kinase effects. patients that’s developing But at the in to patients also external of terms things with well some as with of as hemoglobin the disease observation. metabolic So helped were collaborators

that diseases, an health of a in you adding the and addressing basis may we're thing to mutation, deficiency and of on the So the normal an sickle interesting cell head of two genetic we underperforming able the really improve wrap underlying whereas enzyme very it are cells of to your and kinase improving in around, improving without performance red where enzyme be those the pyruvate in because otherwise thalassemia, performance is defect.

didn't but thought So beta raised because thalassemia was made in a demonstrated that's it pretty we we just -- hemoglobin, that also good or mouse this the model had not only decide [Indiscernible]. it hypothesis in collaborators and we some we do effects to had ineffective sense on we that data idea, good found from preclinical

how in study, together compelling need. all demonstrates that addressed, probably develop and about there's it need then for study there going being to we still And in comes need certainly if unmet going where area this an would pilot So medical think the be think I've but an we to pilot unmet is activity, that described. to ongoing drug we're

and/or the benefited challenge patients combinations, who think the either would about of going from for that approved not of monotherapy. has in in. need you for should the subsets diseases us of think forward know PKR therapies question suggests coming both potential as individual it patients. the see There's we it advent data So of that diseases have so that various would We in these with one about we these always to of activation from therapies, new

Tyler Van Buren

your Thanks very for interesting. It's thoughts.

Operator

Thank from will Oppenheimer. you. our And question come final Breidenbach Mark with

Mark Breidenbach

Chris. thanks both quick for for And in. a sneaking of just ones, Hey guys, couple probably me

patients about a be at to this will on newly give back diagnosed will Are lung the first in bit focus of setting, setting? second little and you a cohorts expansion or going we information that So more AG-XXX. pancreatic or line us Can the third looking in cancer.

Chris Bowden

Yes.

be detail level those yet of you'll closer we're sense good a So providing of a as say, to better of to we it's patient get get sense opening Needless so have etcetera. diagnoses Phase lines really where our essentially multiple setting, multiple we treatment homogeneous took prior of other X patients therapy, had in they could going had who alternatives, that cohorts not the more population. exact no to

your today, forthcoming specifically So question can’t relatively details will but those shortly. be answer

Mark Breidenbach

more And would successful the you bit give I great. up a color Okay in on on a to us [ph] what Can proof-of-concept? thalassemia. as follow define beta little mitapivat related a you guess for a something sort? -- a are little or response dependency also of a perhaps you. and meaningful we transfusion in purely hemoglobin hoping that see it more Is Thank like reduction to things clinically

Chris Bowden

indicators having to with transfused we're would with Yes. patients. would other These the we patients effect endpoint on of because of and positive say, of is the the other I markers. question actually actually increase regularly patients of that respond who that of what as of with important we the could be would are with you erythropoiesis gram definition the the who about The as number ineffective the what the the not are One see well benefit. primary want and the as a in, be ineffective transfusion on magnitude success? experts that study terms increase demonstrating and would signals changes, as be the both those in hemoglobin these well an clinical but erythropoiesis your see argue as I know would discussion should be running that's sustained disease based X coming associated

of we're the at success to then of and look in the okay, you at that a into number further so and the that the to question, is have relating step prior of by evolving to know I look And really think the drug does to activity the at on -- a this of going depend back this we'll terms how fit going landscape. different a So factors. say, definition look profile take treatment we'll back an itself we'll and little safety

in of step making going clinical terms decision further that take we ultimate In a are to development.

Mark Breidenbach

congrats and All right. progress. Thanks for the taking the on questions,

Operator

that and back over turn to session. like any the now would closing I question does gentlemen conclude call for and today's answer remarks. management to Ladies

Kendra Adams

participate XXXX broad an successful. Agios the to genetic year to passion like patients. portfolios. today. difference far also at and clinical been do. of I caregivers across our tremendous important thank Agios what trials. first all half operator. we a like in you to work to we for is us disease for you, joining I all rare physicians for And thank of year and employees dedication who their our would has for we as Thank all making Without so the do execute and Thank of the extremely not could oncology the them, patient’s, would

Operator

today's conference. participating Ladies concludes for program. in and gentlemen, the This thank you

a You connect, may wonderful this all and have day.

Agios Pharmaceuticals (AGIO) 1 Aug 192019 Q2 Earnings call transcript