EPZM - Earnings call transcript Q4 2018

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Operator

Hello and welcome to Epizyme's Fourth Quarter and Full Year 2018 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks. Please be advised that this call is being recorded at Epizyme's request. I would now like to turn the call over to Alicia Davis.

begin. may You

Alicia Davis

and Kevin, Thank good you, morning.

Form XX-K various discussion call important as CEO, those results differ recent our the of in Ross, these current our forward-looking Chief Risk These the Officer. We of and should plans to today views section other to factors, which materially statements not Officer, risks is Bazemore; upon Factor and Dr. our statements and update as Today's views statements. Business be and undertake subsequent subject me and including described of Rob our call our Strategy include dates. Shefali filings. Epizyme's obligation may SEC Matt forward-looking related On no relied and publicly most with will are represent representing Agarwal, to expectations, any Medical Chief as this Actual uncertainties. due to

the let call over turn Rob? Rob. to Now, me

Rob Bazemore

all we Thank of of you, Alicia development aspects and our treatment made progress rewriting medicines. at have other business the mission through epigenetic of our toward and of diseases the good cancer great morning everyone. serious Across novel, Epizyme,

into of combinations types; robust least and epigenetics. launch product and XXXX with progress in We four a clinical for of comprised inhibitor three area this pioneers tumor by Tazemetostat, continue both our in of to lines was build many developments in that solid XXXX and to tumors successfully we exemplified exciting milestones treatment benefits EZHX to the the are lymphoma; first-in-class Tazemetostat’s pipeline year. our year leadership ambitious development; you in non-Hodgkin oral further and Tazemetostat additional our last candidates a excited in at are goals. establish execute are some Those we on new and with highlight today expand made important vision earlier our we’ve of

significant transformational the across epithelioid to new agent. FL earlier of XXXX mid, The positioned the year future for if the is of into through in on and We Longer-term, short, Tazemetostat new Epizyme poised most expansion our for program partnered the through of come confident to all lines for deliver our look yet. aspects earlier tremendous and creation assets Boehringer I most treatment of opportunities With enhance and approved. stand well value planning be launches Tazemetostat Mid-term EZMAXXX, additional Epizyme. are a follicular including as long-term. of company made our initial Ingelheim. near-term advancement XXXX lymphoma sarcoma business, of programs are progress value of combination through to in we growth ahead, we the and will the As in indications vision the and our with am

for work Our companies team few for of submission that the opportunity in prepared. two which preparing at get, one are is well successive an we NDAs hard XXXX but

ever Tazemetostat the a based population this population commercial the large for for Tazemetostat an track to inhibitor. with meeting ES the NDA medical which, if in comer, first Tazemetostat would mark or second patient late we first year, an unmet submit of submit FL lead positive later for fourth successful, quarter high would an to approved, Once all approval needs. are year. a availability for third-line to accelerated in of patient of Then, quarter on approval accelerated the access We plan FDA in last on the NDA our of ECHX

combination studies this to plans of are expand FL executing We into our initiated year. the investigation therapy for of lines to Tazemetostat earlier be with

platinum-based combination initiate castration-resistant tumors prostate are including, cancer and resistant to also studies to are exploring that in solid indications preparing potential Tazemetostat’s We additional therapies.

with EZMAXXX, indication, development We second begin are cell no where finally, treatment established meaningfully sickle continuing to another of our GXa potential year disease, our underway contributed disease And to inhibitor the which of in half Epizyme’s today important have for the novel clinical the with collaborations there through value. modifying research we our therapies. are own are and earlier to pipeline advance plans

which becomes from more as potential and both medical long-term one are to commercial opportunity The to It the submissions believe more our of indications first indicated of become Tazemetostat later no to and the indication expand to lines Tazemetostat with change is People today. rare for is could very chemotherapies, difference presence indolent approval primarily very the specifically for efficient of of incurable available FL. FL strategically also FL to treated ever cancer support This with to relapsed which The an have lives to approval people medical who of will scaled the chemo infrastructure. for ES, that also in our making side-effects. ES could in difficult. indicated If of accomplished submissions. treatment today. make with important physicians treatment treatment closely use modules the an need make very treatment rewriting who refractory NDA associated a sarcoma with challenging with Epizyme. first Epithelioid mission challenging of sarcoma dramatically with patients. to common approved, subsequent the would that commercially be FL for Epizyme. a ES regulatory be with high patients be of as In subsequent patients relapsed and can targeted care our our commercial efficient heavily that aligns specifically make is a is is an platform many This preparation patients cancer through We options, limited a Tazemetostat meaningful in Tazemetostat provide review the also plans which treatments. are have would

not quarter. combinations, off-label emphasizes patients therapy see this problems the an regardless patients. Tazemetostat. the by or is medications. FL new the patients easy potential extended are treated a of and by tumor showing mutation This we a the proportion believe results long-lasting factors want Tazemetostat plan frequently. through Phase medication oncologists. take molecule that therapies year Today, course community associated the same X will we we PIPK FL patients toxicities patients. significant treatment we meeting as These treatment are their of treated of about with with the of our today patients and the time. all and used These for treated an the treated strength unmet investigational NDA less of the patients provide XX% cycle are to so data why In small which These these are are have data with the setting future. currently period third-line and their demonstrated new of manage work in they frequently reductions on the that have later We our in therapies accelerated the further treatments submit majority status role for late stabilize the inhibition. in that recycled and and FL will know of the FL only the benefit that also that how are our population an It’s important this encouraged in help oral, like disease, to the Over study, play across patients from enable last physicians approval want to why in numerous their FDA to FL outcome over are all we’ve EZHX largest of with and need where therapies. and well-tolerated remissions the challenging chemotherapy do actually fourth relapse Based has with have the of and generated through create unfortunately with to durable new typically patients mechanism potential in third-line responses. setting, approved in are This They

without for with EZHX enhanced, confident the With our both submission in FDA minutes feel patients mutations. we and

highlights me Tazemetostat clinical Shefali our Let to key program. Shefali? review ask of

Shefali Agarwal

Thanks, Rob.

on our out accelerated we we are aggressive with both saw well specifically objective track in ES of therapy for population also we reached. for is individuals adults subset very review. indicated represent which patient ES, data, approaching Notably, mentioned, response very in this submission overall duration for a treatment, first response treatment trial second which treatment, are no preparations NDA no XX Tazemetostat and of assessment Tazemetostat treatment-related a prolonged survival patients often any responses population, affects treatments. events. of on year with overall be there the and adverse of due ES for the Phase generally a discontinuing survival encouraging approval yet been that are As median and our had has well-tolerated in the who months cancer no to ES. is of in ORR to to rates largest not NDA this Tazemetostat months. of In this strength has of our in prior patients. quickly continued with saw X we prior median relapsed-refractory for submit in of XX% in and a XX treatment and day refractory request of with of subset Based the the months. durable XX% The at quarter the treatment-naïve eight the resulted the the specifically underway patients patient patients, to total younger In least

Turning to FL.

FDA with X the from year. last we productive We with late the with our study are discussion data also had very the pleased Phase and ongoing

have both received an who from and the comer minutes two aligned more patients all path mutations with treated previously was the for This therapies. without agency. FL by We for submission for on been prior a we reiterated EZHX with Tazemetostat in have or

patients EZHX saw The rate and cut-off, ORR high patients clinical Notably, the phase is which median progression-free survival has patients due and activating that both We agreed will of XX.X very best presented data still remained NDA mutation were maturing don’t weeks. last led rate favorable data relatively data XX% and adverse since with durability EZHX and As fully in year, events. XX the no mutations we with cohort with At patients includes consistently durable appreciably. of at of last discontinuations off response. XX.X a wildtype note many the our treatment EZHX treatment a our had package EHA the of EZHX activating low EZHX XX weeks change response based in EHA. May EZHX, to EZHX interim to ORR showing patients confirmed this of enrolled mutation patients we wildtype with in the of with XX still Tazemetostat duration expect our early presentation to patients, of we mutations. XXXX of disease and progressive on are median as mutations be patient FDA, that In X as responses safety do with with

wildtype experienced of EZHX even to incredibly from XX with reached confirmed EZHX trial-defined will XX continued ORR these of weeks change of median approved. for mutations on progression. therapies. in not an data and year, patients, expect the XX.X cut-off As and of of response of utilization demonstrated PFS and these after of they were with response XXXX, in to median well a able meaningful not data patients reduction back the be Tazemetostat patients are some burden, any and we XX% on a today’s wildtype enrollment EZHX XXX% with something we over them therapy meaning the in same weeks patients patients stay do Notably, meaningful of seen a clinical believe XX% saw With tumor objective EZHX wildtype tumor a wildtype in Nearly patients therapy patients we mature patients completed with volume if if even of frequently reduction in confirmed XX% effect way. never duration in a for

As patients those of Study from we The outcome FDA of compared confirmed wildtype line thus therapy EZHX. X Phase with with not are treatment shared in Natural and provided patients complete. with achieve activating have better earlier end patients kind this with largest conducting in FL in EZHX is the to do far which was meeting December year, any its a that in of our two-thirds we patients History data mutations

agreement with we we FDA reached with responses trials Tazemetostat. such, are used seeing specifically As are in the to our

history treatment. line of natural two data with patients plan included understanding In same in up be from least NDA XX% addition, at in of as have XX% of all the that all meeting updated XX% data is At follow-ups to ultimately of years in mid-year previous patients or would the wildtype our frequency submission. of months regardless the planned our the a of approximately NDA XX submission, studies a EZHX response mutations to a We patients medical the had recorded present FL to time of will at at and more. study

conduct its we second-line to to our a planning the reminder, to of with this program We the for in for ahead are initiate full a submission. progress Tazemetostat label year to expand that continue As into the population. a FDA confirmatory NDA plan could of of first it line engage and FL of approval half treatment

the and prepare will of expand ES combinations. also for be FL new settings for we to initiating NDA additional we into While submissions, Tazemetostat its FL use earlier to studies

of clinical RX combination combination on referred patients study We believe we alone. this a relapsed RX track Tazemetostat regimen the chemotherapy-free FL. Rituxan could the of an be of with superior presented a in disclose Revlimid population for lymphoma, in We are plan start in with patient management upon to in and expected refractory plans plus at treatment compared in Rituxan responses to as we triple a relapsed treatment this RX to Rituxan, for which will this of with begin resulted December in is patients a of initiation. as final with with with mid-XXXX. was last finalizing details combination accurate treatment refractory for year the to setting. of are Data clinical study in that second-line combination potential showed with study a option We when factors positive trial ASH the emerge second-line Tazemetostat And FL. reflection

the about combinations opportunity our these treatment FL could both potential excited which patients. of enhance are greatly We in

on the risk opportunity we opportunity combination data based Association was risk, on in the year combination high presented Study patients promising patients expand patients R-CHOP high addition, combination generally to Tazemetostat showed into future. that well-tolerated and are FL data to In is a previously the resulted and partner the B-cell The presented with ASH encouraging FL untreated the huge, path front-line Lymphoma the large with that by all last evaluating activities. providing treat in in the lymphoma, at

study Beyond cancer small to FL, scientific pivotal XXXX. we cell ovarian with dedication with triple a seeing for cancer, fruition based mid-XXXX. the the cancer standard get prostate cancer, combination solid tumors Tazemetostat moment. for from tumors hard to with the clinical of plan am such work what to like current lung to impressive many for the trials forward combinations initiate of investigators very with this come in as, Tazemetostat different of data. I to rationale post-treatment of across and to and thank castration-resistant I’ll promising helping to negative we I for We are data look plan combination XXXX. patients. the care our breast advancing of has a to Also, company of development and is on additional treatmental proud also in initiate this certain the study for the half treatment and time team accomplished in our the pre This second in following a obtained inhibitor attracting trials the cohort patients study biopsies, in platinum-resistant PARP

the turn Matt call opportunities I’ll EL’s over FL review Now and the financial results. to and to our market

Matt Ross

treated with Thanks, have with mutational two strongly at a that to irrespective prior first of those significant Shefali. reach starting or follicular been We had EZHX more lymphoma status, believe their who patients opportunity least therapies. Tazemetostat

given the later With that be in United setting in a approved, our setting, EUX. to Tazemetostat. research of for that of later a patients in third-line our could benefit there in setting research tells target treatment-eligible from market from the patients X,XXX approximately of population these care or and would treatment-eligible patients a we believe about States standard treatment learned patients adoption there today. XX,XXX of third-line defined with lack gain that have poised in XX,XXX FL, the if Tazemetostat A we the truly us approximately exists population rapid in are eligible that number As significant to address are efforts and

of this attention patients first therapy opportunity earlier label potential Tazemetostat and In also second-line be Based FL as is there with are XX,XXX eligible are substantial generated for approximately our with action, the emerging in Tazemetostat for with lines to the a current believe We we treatments turning option novel market and the therapy. and for to treatment representing such expansion today choice settings RX well its systemic the used broader treatment the agent. a opportunity and to EUX, U.S. in or data of of on combination developed be front a agent Rituxan, or becoming mechanism positioned and R-CHOP. both second-line by

clinical our expect potential Shefali development will expand studies new we with we market advance with program Tazemetostat’s it. As this outlined,

treatment that like is metastatic sarcoma, year been rare one for ES treatment need tumor to type. There for near-term living given most the believe of will truth XXX once any specifically Adriamycin, less disease misdiagnosed Ethosuximide, ES United for survival The treatment. suggests only We indicated patients it disease not figure which, currently commercial approximately for are of than literature metastasized, meaningful a be underestimates often multi-tyrosine the Moving with the the for in with of and and have XXX is patients the with rate or prevalence treatments The eligible available disease of the the a opportunities. there epithelial available roughly kinase the is have new of real. lack treatment States, for this the includes options in patients ES chemotherapies inhibitor Docetaxel this advancements living our best systemic Gemcitabine pazopanib. and

do I ourselves. infrastructure am of and professionals As patients the diagnosed. to in with always States confident for end up XX is that commercialize before, a these plan treatment that our about once center specialized Tazemetostat almost in commercial cancer efficient can given by an we we’ve so United mentioned scaled ES

correct As We is that adoption be hopes and priority into positioned a physicians program the Tazemetostat we that rare substantial. today. look they our this prepare can with to option this, a reality. for would sarcoma, ES this a approved the believe physicians be advancing if so make top turn well forward educating by on for diagnosis patients would We to

and our financials. over proceeds net Turning in million which cash revenues in and milestone We follow-on approximately $XXX and of with $XX now GlaxoSmithKline payments in upfront cash recognized million from our from year equivalents, to October. our and XXXX includes Ingelheim million through $XX.X the course in approximately the partners financing Boehringer ended

had executing we we the multiple in turn the enhancing As XXXX. to strong most to and We for operating now of these evolution company approval were into our available operating this clinical call the and focusing and the growth Epizyme. of milestones Eisai This achieve expected of We with shared up. stand our and each January, quarter I’ll NDA through a fund both priorities back to to extended our and to efficiencies second first including and on milestone multiple important us our as Tazemetostat Tazemetostat, by ES us as the FL options EZMAXXX important wrap partnered year runway programs. upon head Rob able of to to of ES we continue back into our submissions, over us achievements. takes strategic relating associated payments to financially our runway regulatory

Rob Bazemore

Thanks, Matt.

and to be for prepare a as year back-to-back our product NDA XXXX we if heard, set two important launch. is submissions successful you’ve very As for

of us, to execute. we a ever ahead enormously lot that are proud more to of our of While and pipeline we am prepared business. dedication than the recognize advancing the still I team work and have we

championed givers our the appreciation be the Without our care are in have way. studies extend where not their would along Lastly, patients, and Tazemetostat physicians today. we participated we who contributions, to we deepest and

exciting are your ahead up we forward looking With take and on you along We open to questions. the way. year to will the our updating to a very line progress that,

Operator

comes Instructions] Jefferies. from with first Michael Yee Our question [Operator

Michael Yee

Hey guys. Two questions. Thanks the Thanks. Good for update. morning.

regulatory question what for and about for prepare much you that update EZHX change And shouldn’t the the much enrolled, think you a greater in be as how frame mostly think just you was filing we EZHX was, approvability when help be that should for maybe update. in the or how precedent that question handicapping and what would approval? your would indication change the it follicular lymphoma durability, you could so that ES, the First from wildtype prior denominator in give much. Is in the patient last pretty is, data second population

Is good update? just that rates, response we correct major much. change framing Thanks. So, about feel should that shouldn’t that

Rob Bazemore

start let question, Mike. So, with that me

patient a mind of first answer to change about easier I one fully part expect as the substantially. was don’t the XXXX. in think the enrolled wildtype. it’s population that data wildtype Keep of We will the

So we years have about two follow-up. of

the last reported still the time disease at there of had year, on stable one as EHA only left was drug. think I data and who patient last

the data the submit and very the in been And the largest so prospective. to ES to we either that’s ES, our to so, your we on we is in when with change fact, prospective – those have filing Phase don’t With is ever be represents or spoke of in done the retrospective FDA to X regards that likely them back for cohort study in expect this to what study the question ES approvability close we fourth package approval. this ES, when presented we quarter NDA

know, we treatments in you are As specifically talked about there are indicated no today. that this, when sarcoma epithelioid

Most cohort. of drugs year. of we these that the really quarter isn’t with path submission drugs fourth to success. identify the have any approval used approved had accelerated in a In we with So sarcomas broadly XX benchmark a little published did a last on to able are X interaction soft were meeting similar for had to FL for based We but back tissue FDA. where are to an patient in Phase positive are XXXX, in this the that they data there as ES, treat did we established more We specifically. in is patients the

substantial. safety will We rather expect database this be for the

will a will that. We over that FDA’s along have we today And the focus that be goes the of safety the Tazemetostat package the patients only presented been with evidence response, review we ESMO some on with of response XXX part that the treated and that totality have these of is sustained durability disease patients. of long-term rate, in back overall stable objective not year durability actually that very but last September other important including expect at also survival data in

data, based on planned of confident those So, NDA epithelial the feel our for sarcoma. strength submission we in

Michael Yee

Okay.

the lymphoma, you population you just clarify question, in all enrolled, when were the again So much EZHX if expectations to get on follicular before to data mid-year going there hold. back to to the some frame that vastly there? change the happening was had at still majority stuff first which update that How

Rob Bazemore

I mid-year we when is, of think thing we’ll data you have present all year expect the the that patients should now. this first, Well,

we reported XX you EHA, all presented as assessment. EZHX patients will enrolling year been at mutations patients as still cohort response no with were So, EZHX included as when data. in we The Last when high, consistently matter has point these we the all be well out. mutant rate the wildtype

we So reported, it I expect The but consistently response last the that at XX%, changes it’s major high. was don’t in see time will rate. any been objective

just of response. your of enrolled. been responders should summer thing duration cuts, been data data on to new report those They’ve start when each I duration pull time median is, interim we’ve think that you that done because have this improvement down we and we new had response, patients see

and in don’t fully see look we in is expect view, of of patients don’t enrolled, populations. we study response the and that mechanism the from would of mature the those mutant to so, that would I point and just action patient duration the to ultimately Now coming different expect begin that wildtype have new a

Michael Yee

it. Got Thanks.

Operator

comes question from next Cowen. Our Yaron with Werber

Unidentified Analyst

the for Yaron. in Europe? least? second this about is timeline Leo question combination all lifted on you holds of is my should the been is, the in question Taze what’s FL, And the Hi, the eligible first we expectation Do for at has be any timing the My have in length on on data? for it Europe, clinical thinking

Rob Bazemore

So, studies. timing follicular that I’ll start the combination with you asked lymphoma question on the of the

to second-line We have this combination conduct a is that two, that plan to setting. the RX planning I we think at with look we combinations are important year. in three There

We expect the middle the year. of would that that study in initiate

We around is, Rituxan We again expecting start patients frontline that’s are DLBCL. high-risk study mid-year. investigator Tazemetostat R-CHOP initiated with alone. also patients, the in with study expect there study And study been are DLBCL. trial we’ve then, would a elderly in a setting is conducting to that third begin These with that

frontline to to the not comments hold. also trials. of we we We with patients as from on around with working the those are extend partial Those when that Study be the to to are Association And expect regards this Lymphoma our would would just data to Shefali initiations the also are studies. then where study that ask I’ll FL beginning include high-risk We’ve and would hope guided mid-year.

Shefali Agarwal

Yes.

of we in answered are we have in So, Europe, hold all terms partial France, off the hold in Germany for and questions.

at looking So they review just their are process. last

still to there? quickly very Leo are off be hold in you expect We time. short very

Unidentified Analyst

that’s helpful. you. you Thank Yes. Thank

Shefali Agarwal

You bet.

Rob Bazemore

you. Thank

Operator

comes Our Stanley. with David Morgan next Lebovitz from question

David Lebovitz

taking questions. Thank much my you for very

cancer you prostate step how you First, behind rationale one synergy studies upcoming Tazemetostat with could what’s further, and elaborate tumors? platinum-resistant on specific the in targeting PARP? might tumors? the expect Specifically, those And

Rob Bazemore

those to Shefali, Certainly. answer I’ll if were you questions? ask

Shefali Agarwal

Sure. start going validation cancer. castration-resistant for a clinical with lot I in well Basically, is to there am prostate as of as pre-clinical prostate, prostate.

standard improve believe shown and advanced in to that to, lines prostate responsiveness of patients and is also that correlated we we have cell expression data in – resistant to the protein disease EZHX progression So, to say are if who some pre-clinical with have the care cancer. therapy inhibitor EZHX

on standard a prostate to the resistant in and factor that can that do of we we are study therapy. castration-resistant So, basically, data in believe care pre-clinical who patients cancer based

a a did did there is in were pathway of ATM pathway. were the clinical we post-biopsies we in EZHX that where pathway in lot synergy we lot action study PARP, and which activity. of inhibit data the our and tumor, there of terms solid EZHX HRD In and pre inhibitors like EZHX each shows enzymes saw PARP looked synergy at increases that where There in the actually pre-clinical and

in we so, have inhibitor patients have so PARP to platinum-resistant modest preclinical cell on in in activity as inhibitors EZHX who and PARP PARP responsiveness that that and PARP inhibitors based shown seen we have is, have what believe lines, platinum-resistant synergy And inhibitor we patients. inhibitor improve seen and the

and We able be efficacy. to will combine the improve

David Lebovitz

any again and that. inhibitors for once One much trial after very you year? there checkpoint last additional current at question. to halted the Taz was looking Are Thank Tecentriq plans begin

Shefali Agarwal

always we Absolutely, very encouraged. are

to We terms lot PCM are Tazemetostat. cell. about modulation about I in excited in look pre-clinical synergy data definitely think And plan and non-small we inhibitors to between checkpoint would talk We that. of of at have very

remind to well. that with actually trial we this as combination did Just DLBCL within checkpoint – you

And at partners so, our of the with we the will be releasing year. that end data

David Lebovitz

Thanks for taking the questions.

Operator

Our Oppenheimer next comes question and with Leland Company. Gershell from

Leland Gershell

review one good questions. us if years required Thank over wanted my and just to you milestone morning. terms for payments progress, Hey, Thanks could for approval? ask two of the those filing taking you. I next in to for just with

Rob Bazemore

that. review Yes, certainly. Matt to ask I’ll

Matt Ross

Leland. Morning,

is So, Eisai to filing. our with the regard regard there ES that’s with expected agreement, under to the so $XX milestones million

year this pointed is morning that the fourth approval which then would ES, fulfilling the of filing as And then, in FL quarter the we as this another we of at filing million. think upon the about the occur commitment call, an earlier $XX would and million. have of So Rob quarter would in in out $XX that second the expectation in

Leland Gershell

all Good. had. much. Okay. That’s Thanks I very

Matt Ross

welcome. very are You

Operator

Citi. question comes Karnauskas next with Our from Robyn

Robyn Karnauskas

all Thanks for question on congrats progress. my taking and the

get flows talking cash think much So, how that are these about and maximized you how all thinking which how they real, Can are trials? you are seems your trials cash cash a us are have will little runway trials, you to you help me. much about running bit year a of given how and combos are cost these and and about just these especially maximize – expenses to capacity thinking you then sound starting like over so am just I you

Rob Bazemore

question. Thank Robyn. Certainly, for you the

add if to anything. Matt I ask I’ll then missed and start me Let

XXXX down and substantially the generally, sarcoma, that I terms the studies forth that of some lymphoma, in think large reason looking up about move before of in definitive sort that DLBCL combination needs are so coming to these are we’ve going new and is, trials. year, initiating Phase we proof-of-concept into they are our the are and into demonstrate of then we for compared that larger of costs as been we not running cash how follicular same the at the way them of them for the is wrapping early all activity different studies are are think At X on and some epithelioid part to those. we time

small cost just has Matt sales if think look think patients we as the based And don’t commercialization with launch reside. this the so to patients United medical those then don’t significant before, explained so it’s in those year. is and the organization on we the relatively necessary make We of we small and can of affairs ES. you of expect the where And efficient and number States a cost commercial at a in relatively investment

in a you at know because we for XXXX high I Matt, roughly I cash to offsets. I similar don’t and used level, our just would of what XXXX, very those at So, if want look to missed to be add? needs

Matt Ross

with Rob. be we’ve where studies are data early and to agents what see evolve, broader we articulated shared we component. those these combine early proof-of-concept large established view of effective Again, and just development move as an more No. Tazemetostat just we’ll then flat that as starting relatively to how into Thank then, R&D you, perfect. the point can out these we are expect part due it’s has the in from again to Rob year-over-year No, fact

Robyn Karnauskas

And just a follow-up.

are you Are different you So, additional looking that avenues, assuming types to partnerships any to to you’ll any get bring go any market have a other year? cash of at cash? beyond in might additional deals or for the

Rob Bazemore

that, and have a we to that we of are us a an interest have as all the looking has of developing we partnership have always the we might partnership are be that regard you to different considerations, as we options near-term front regard performing organization that in is will it something strategic continue that to efforts with it and evaluate. our we we how certainly With fact So, as to will pursuing at the value been Tazemetostat are certainly think we There lot two has believe of how to NDAs. given in imagine, about incremental Tazemetostat. level how considerations, the

get we we can side. get can faster how there commercial equally on that greater and So the lift

in as considerations thinking well. active those are about we So,

Matt Ross

partnering to well, very have has and pipeline helpful provide we that It’s as on been additional The work are early-stage revenues. Rob to helped us. done

earned well as You from milestone Ingelheim. saw Boehringer both from revenues we’ve GSK that as

runway. revenue. achieving also expect this revenues count we from not cash recognize baked Those into additional the our We them milestones We don’t significant are until year.

additional that’s So source capital us for this year. for moving of

Robyn Karnauskas

Great. for Thank color. the you

Rob Bazemore

You are welcome.

Operator

The next Lawson Instructions] from Peter with [Operator comes Robinson. question SunTrust

Unidentified Analyst

I done, Natural for – a that Hi questions. you the And Peter sort that our about taking quick more would trial color patients for is [Indiscernible] that the little talk guess, everyone. includes Study, used that more the about guys your guess, to some Thank NDA you I Lawson. of History be just like confirmatory that exclusive of those guys more question would submission. This number criteria and on is after program of enroll programs? towards the what on like FDA design anything or in you have

Rob Bazemore

are assuming natural are program am sarcoma confirmatory natural we Thanks epithelioid talking plan or the about you the how the study, to confirmatory When I for the study question. in you history history about evidence? use and asking

Unidentified Analyst

Yes.

Rob Bazemore

might the I turn it be natural our study history in of over thinking Shefali used. terms on to

Shefali Agarwal

Sure.

retrospective retrospective history we was the review. did study that So, with charge natural

We the have completed study.

ultra-rare is as to know confirmatory be order that you earlier, a As highly mentioned for ES studies tumor in us ES, type difficult. large will Rob

is use that natural FDA. what and we to do a to plan So submit confirmatory history as our of part study evidence

in history natural fast and as a ask study a we this engaging trial. We on the using the with just with of of be and align track have would them form ES pre-NDA meetings confirmatory FDA a instead confirmatory evidence

Unidentified Analyst

I see.

natural to terms compare Phase can your and response any cost, the any two populations we history like believe doing was be survival we trial in and the on it’s between data trial the like take and So X from pretty comparison straight-forward data studies? use of going

Shefali Agarwal

on this Yes, history up something was which context it's of largest and that’s the use aspects as not I FDA study you a in well. kind discuss really great absolutely, and study that we it because study is it compare of data opening history is talking different question natural rare this studies, clinical the align prospective about can its this and and the natural the FDA use how the in use look the to to at our the study and data with tumor hope types, how can and that in

we our the to course, to of a that trial. have hope would use study this instead confirmatory to and align be Of FDA meeting, talk as in Pre-NDA but evidence the

Unidentified Analyst

one on you Thank data I have natural quick you history the presenting Great. just planning really are when guess, this on on, do last any updates you year?

Shefali Agarwal

year. hopefully, study. the for the history mid haven’t on natural presentation But We of the guided

Unidentified Analyst

questions. Okay. you for Great. Thank taking so much our

Operator

time. am showing not I this questions And further any at

Rob Bazemore

today. Kevin well, thank and for us all thank Okay, you joining you

we clear ahead a year it’s very us. think of exciting I have

execute you Have of do. all place in and forward progress. are look on a lot a and our have a well to to Thank as efforts our prepared excited you be to of we updated But We we this everyone. these to company day. on good work and keeping

Operator

gentlemen, today's and that concludes presentation. Ladies

and a now disconnect day. may wonderful You have

Epizyme (EPZM) 26 Feb 192018 Q4 Earnings call transcript