EPZM - Earnings call transcript Q4 2019

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Operator

Hello and welcome to Epizyme’s 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

to good release and and morning issued at and we XXXX found can Thank our on recent morning. progress press website slides release press outlining results. quarter we’ll and a refer financial be you, epizyme.com. The This which our year-end fourth

Chief Bazemore, On Shefali Officer, Medical Agarwal, Rob Ross, Financial Strategy CEO, Tombesi, Officer. call the is and Chief Chief and Matt today Business Dr. Paolo Officer,

and the representing SEC undertake related relied discussion may are form, expectations Factors and other will these call These very plans include those Epizyme's Today’s our Risk and differ recent should of XX-Q filing. results in upon to of including of obligation not statements. described to We which statements to Actual to views be date. risks statements looking due certain any important subject subsequent factors represent our section as the current as forward forward-looking update uncertainties. most publicly and no our as materially views

the me let to Rob. call Now over turn

Rob Bazemore

to for all off is already incredible start. today. XXXX you joining us Thank an

forward We a later fully transitioned into look company, second biopharmaceutical our potential product successfully in U.S. this and integrated year. first approval the have commercializing a to

to top our TAZVERIK to ability and Our further is maximize commercial priority strengthen value. to clinical the potential of create long-term

of of inhibitor only INIX-negative FL. and approval, to for EZHX as for to a oncology we've treatment these now unmet This patients for need of verification benefits and epithelioid favorable with indicated patients shipping approved drugs FDA the sarcoma new follicular and a with with ES, specifically not TAZVERIK or profile the Epizyme since overall now but patients. the only calls diseases, approved and in TAZVERIK the treatment. speaks lymphoma, and also first tumors other first then were to is and only the market. seen we patients And week in Within

who of lines across Rapid launch execution, looking ES evaluating for TAZVERIK TAZVERIK our at new increase been eligible for aimed particularly a patients, educational ES. expectations in see of diagnosis we high efforts, of ES. ES result all the of treatment. have patients are of by of of and appropriate have We to prescriptions, as physicians the an adoption pre-identified In number conversion rapid into

allowed NDA commercial scaled Our launch established being infrastructure. sized out our in in for field launch in oncology of flexible the efficiently ES acceptance the support the the and to It filing. potential FL recent a has FL, our build is presence and of now up given

intended, The systemic modules NDA, NDA As has disease able progressed were with leverage relapsed submission strategically we to from FDA and the of more or therapy. two following FL both lines FL, review priority review. for has patients TAZVERIK ES for or refractory granted our whose streamlining our

Importantly, granted earlier as the expected NDA, June designated than our agency a an PDUFA application supplemental for XX, sNDA of XXXX. and date

relapsed with Given and patients TAZVERIK this to refractory to rapid our upon experience approval, we test ES commercial launch seamlessly disease. achieve adoption or market timing, on for to build with intend FL among

nearly We've in use understand TAZVERIK research FL as as commercial treatment completed the these market well patients. in position for to FL expansion, our our optimally order activities landscape to

data our approval TAZVERIK of development clinical starting intend FL, goal to our making our to and third all The plans to in patients future. FL line later only needed to we execute available is the quickly point and support the in generate

treatment lines. of with setting, meaningful also agents as the combining year Our a the all open second enrolment. is this will of FL sponsored The frontline benefit commonly to and provide line TAZVERIK trials, well setting trial in optimized investigator and the study TAZVERIK to in confirmatory begin evaluate number it's for establish data TAZVERIK used across as

of expansion. preclinical Based our believe label an we knowledge multiple opportunities in broader with EZHX to date, our of for range explored providing and clinical treat than on its even experience potential we and strongly cancers extensive biology, have tazemetostat, to

with number academic a we a of other collaborators working for solid advance a tumors, tazemetostat malignancies treatment as win. and studies investigators are to clinical as combination the has hematological and to monotherapy We it believe for where and opportunity

point, am of of I'm Today, excited a far ourselves find transition for activities we've how robust year and come this set future planned at to I a successful for we inflection company. a very key proud with enterprise commercial the and the of a ahead.

an on launch TAZVERIK it to progressing. turn to Matt update I'll commercial Matt? how is the over provide now

Matt Ross

an early I'm approved. from Rob. be which into commercial larger launch, translate highlights Thanks FL delighted of the indication, opportunity we to our some should should well share

Our of making ahead great to team completed on TAZVERIK every we our is first February in When United our effort, patient Thanks received ES approval patient XXrd, make available committed this to it the appropriate schedule available we we TAZVERIK’s days. patients TAZVERIK within States. intention XX to to and on January announced Xst. to

guidelines In treatment sarcomas, practice NCCN an the for for patients option addition, with treatment was indicating TAZVERIK added consensus appropriate tissue TAZVERIK is by soft clinical ES. to NCCN that

We inclusion, convened particular, at TAZVERIK guidelines. added treatment recommended are to very which speed with committee the this and and NCCN the in the pleased be expert

A TAZVERIK. that patients which significant to and strategy that ES our in eligible XXX that diagnosed ES with the a approximately not is is of the an on help is patient's may provide accurate initially. part diagnosis earlier in commercialization they United is of there misdiagnosed often physicians journey. educate known, are XXX estimate well rare We It for are about States cancer

we this larger of estimates. prevalence true a we which the understanding believe to than ES, of is Through current greater the effort, gain expect

in key a commercial factors; them experience physician as It's their and to patients, success physicians prescribe early their eligible is patient days supporting the and enthusiasm program. largely have three standard-of-care all first the ES prescribers on access into wide seamless far. by Reaching patients. support our based adoption TAZVERIK’s with Our brand, are we and positive for desire the so ensuring and that through Epizyme the and TAZVERIK launch, TAZVERIK patients pleased with to now providing

has new active, been patient facilitating TAZVERIK and fully now Epizyme to access prescriptions. is

are we ahead, physician TAZVERIK, to to As of we a time covered fill. measure will including no how access, our lives number and adoption of barriers prescription look to commercial with elements success, there

To build overcome of metrics, to disease large our networks making with facing and support to for testing, effort finally, generate customer to these team and partnerships to awareness is and create and treatment provider the of TAZVERIK. on collaborate demand community to educational availability a identify awareness tremendous TAZVERIK barriers

limitation. formulary relationships and national established key have payers striving access and we without addition, regional are with to In ensure

built business all full pharmacy TAZVERIK specialty receipt benefits upon to of that prescription designed and a prescription We ensure completed patients filled a for five days. investigation plan their within have have their

Follicular all It considered of multiple with while indolent be non-Hodgkin's usually the growing design lymphoma, to launch FL. patients to curable form of of TAZVERIK live ES strategy, not and also of can for and and commercialization NHL The enable or XX% is through us the going but a of and treatment. cases. years, accounts lines team is for our XX% expertise pivot, slow efforts our to support commercial lymphoma will quickly many

at and are Approximately advanced in the patients diagnosis. XX,XXX the of States, patients disease overwhelming United diagnosed annually have majority

different to will trade-offs issues. initial patients regimens and major therapy, will clinical efficacy, their While respond are relapse it usually many of the toxicity

disease the XX,XXX are States. XX,XXX to patients in with estimate and conservatively relapsed that United We there refractory

Our ultimate later relapsed to starting all refractory, of make into is to in third intention or patients, then and TAZVERIK treatment. FL moving available line the lines setting, earlier

frustration are based on and quality research extensive black decision instead treatment or potentially patient difficult that to key conducted market and limitations community by desire decision due diagnosed off-label They compounded leaders, typically preserve mid-XXs. and have with and use life. progresses practitioners, performance the treatment, FL palliative their opinion influenced an warnings. stopping of agent, been their a perceptions anxiety today's to regimens, consider patients Once They to treatment and decisions management, by and that's process. side face face approved are effect with treatments. previous proactive turning are co-morbidities, in intense age, an We box can The understand their previously their requires prescribed, of take to their patient’s further something available therapy a care. making

patients tell attributes, value would rapidly easy uniquely it with why take, offering to provides Our new efficacious, positioned that is durable we is is us and will physicians product demonstrate remissions, an them accepted. safe indication, This for and and and alternative treatment widely be hope. that that insights is TAZVERIK this believe and

based activities to readiness launch our advance field is in FL ensure PDUFA date. our of ready initiated our well team have we Operationally,

team oncology. leadership representatives all depth, and have sales sales of our and our in completed we place, significant whom have of hiring experience in Our is

we as and We I have to year. forward progress the sharing updates ahead, year look throughout an more important

broader, tazemetostat. the Shefali, I'll to Shefali? to now review for turn call our efforts over development

Shefali Agarwal

of Matt. are of The filing and ES TAZVERIK for Successful approval our imperative. for ES Thanks recent is FL both FL acceptance the our of sNDA incredibly execution program and exciting. FDA’s

this marketing For forced commitments. as the trial in ES, as on-going well the global frontline ES includes confirmative

the these year. study are we portion of studies confirmative expect All into of efficacy and the this underway, and later safety complete to move portion our

demonstrated the submitted are focus who relapsed will clinical refractory of efficacy least received trials FL on including as treatment The shown independent is FL, ES, of primarily The systemic committee, TAZVERIK tolerated a patients benefit lines at indication reviewed has For we in for clinical safety our and by resulted sNDA our we review many anticipate data. be modules this population. because X review with the phase or investigators, this for have generally assessed well in data prior two patient both in and an therapy. from to

have that support commonly addition and the latest planned further third rituximab, venetoclax by studies FL using including In treatments, setting with inhibitor. underway or combining or line investigator-sponsored to multiple BTK used we TAZVERIK, to study,

same patient earlier TAZVERIK it We third-line profile make that attracted also for in for believe makes settings. setting that patient attractive the in

to We the on-going global plus in our designed TAZVERIK thoughtfully confirmative placebo second-line RXversus with trial compare patient setting. RXfor have

The FL, and TAZVERIK with study the synergy mechanistic the between rationale DLBCL preclinical in design our suggesting job supported including combined RX, when activity of data, TAZVERIK combining trials. our is refractory monotherapy clinical or the and demonstrative by on-going and evidence the benefit relapsed TAZVERIK Revlimid TAZVERIK for as in by

activity enrol trial. the in in refractory regiment, addition, patients, which our we intend Phase to reduction who are to observed first-line In we X have in population

a how early implemented design study extended therapy adaptive to based interim include treatment assessments, on to TAZVERIK effects the survival to and study effect maintenance performing. the designed state, progression have is just on the help the treatment free through trial us understand allowing of on we continued an Further, have and

we and second-line in label positioned, FL. and successful, support will all a For this combination approval that trial if are these and are optimally reasons, confident full

year. in the actively trial, of are we We to patients this portion screening and line the complete which expect safety

to setting, intent our demonstrate high-risk our trial R-CHOP patients. who with combining benefit support front-line newly in are To TAZVERIK high-risk patients also the include a expanding diagnosed we DLBCL FL

the is conducted a know settings analysis Beyond will ES collaborative both a benefit we tazemetostat where many this identify with FL, and efforts. population effort believe, plays EZHX which clinical can demonstrate have central we a year, in-house of and and treatment cancers in We execute patient role and expansion through comprehensive to we that tazemetostat.

see effective of types strong need and greatest There we based new, the safe which for on are options. are treatment rationale where tumor scientific all four and opportunity, the

lymphomas in in DLBCL, as of EZHX b-cell and The role the other plays and such biology. CLL particularly malignancies, malignancies, because first is CML hematological b-cell

proliferation. which oncogenic we EZHX. to inhibit proliferation patients Regardless and we as mutations, FL these enables leading governed of EZHX expression anti-tumor cells their inhibiting believe growth in seen can the are by tumor wild-type activity By cancer with EZHX,

or dependence solid The with or defined mutationally a of certain alteration presence focus -- leads a on which such these area EZHX, or of loss tumors tumor, chordoma, next graduated mutations and EZHX tumors, certain normally cell activity proteins as a other can melanoma cancer mutations. SWI/SNF growth. of to In the is the

we By that tazemetostat innovating believe their selectively state. function, innovate with to abnormal we natural EZHX can cells restoring

is as EZHX which as given, cancer and survival DNA overactive is and at in breast, solid triple activity, resulting cell a the becomes least chemotherapy, cancer is increased damaged When lung, to abnormal reprogramming or such and ovarian growth. cell chemo in negative involved mesothelioma. tumors transcription to chemo small [ph] type third resistance The resistance

cells with inhibitor, can chemotherapy. By resensitize treating we we an EZHX believe to

midst plays a know the are When to to damaged, to is that PARP leads inhibitors. activity of PARP inhibitors also in EZHX DNA EZHX which the given in responsiveness role We PARP resistance inhibitor.

augment tazemetostat, inhibition EZHX also treatment. may to we is we can The response believe for inhibition. with EZHX By blocking tazemetostat area resensitize in a tumors to immune-oncology tumors to PARP development fourth

anti-tumor enhance activity or microenvironment, By influence be to cells. biological the test. functions we tumors in may desensitize can which more by Pre-clinical EZHX with the data suggests immune-response immune-oncology tazemetostat enable tumor in interfering multiple can EZHX to inhibiting sensitive

to creation multi-center prednisone This castration-resistant include Phase in underway, life combination with strategic development we is enzalutamide with investigations naive tazemetostat cancer. cycle clinical Today, value plus future of XX the randomized tazemetostat of a prostate have Xb/X which Epizyme. patients global, or chemo in metastatic abiraterone evaluating

an four to this trials the inhibitor additional we’ll which design year, have inhibitor including of will planned work that use. plan PARP the up the running of We and the PARP following selection of studies completion preclinical guide study, a combination

an for we all providing tazemetostat We to year progresses. strong believe role had on a the and preclinical studies meaningfully this the forward types to area clinical look and of place in easiest update to opportunity as With tumor data, an these supporting patients. four these address

call I our now review turn to financials. Paolo the over to

Paolo Tombesi

good both XXXX morning today, results. issued we with and quarter our everyone. release and a Shefali financial full fourth Earlier press Thanks, year

funding cover just shared, support So bolster of opportunities we position maintain ensure our will also a supporting cash vehicles have adequate our the of we to to organization. and few the I breadth but of highlights. pipeline full a our just we to number exciting growth Throughout utilized XXXX,

along of This $XXX executed funding million XXXX, options. deep investment March followed conduct before making other agreements equity Royalty by with raise upfront Pharma $XXX.X an Royalty included Pharma diligence due in an equity of a November. million of with in

January. include cash million discipline, a Pharma based focus with put $XXX position we of on as cash, and very with and Royalty December Notably, XXXX does started a cash this through in financial diligent not in cash exercise in raises the marketable additional option strong with XXXX. equivalents these XX, securities executed million of $XX Following balance equity

established This with separate with intended and interest period than of milestone Pharma, of a an As a million $XXX we only Furthermore, is by FL. million fund Royalty regulatory we $XXX equivalents. result, Pharmakon receive year expandable cash cash we this more with we loan of TAZVERIK Eisai. if approval to three-year started affiliate $XX in million loan four facility the an to up agreement under Advisors, to additional a owe

collaboration We in Turning payments quarter for reporting our revenue, under achieved research in collaboration product revenues monthly its million $XX.X along with to TAZVERIK of which milestone by in was Ingelheim which Boehringer Epizyme. will first XXXX, approved recognized we condition the January. milestone PRMTX the since in target the begin was revenue development inhibitor reflects discovered GlaxoSmithKline from from

the Esai that Note ES Pharmakon. early operating Our also which global our GAAP which milestones of were program. this included trials, R&D by million million. and for $XXX FL for NDA the were and expenses $XXX.X to includes tazemetostat million a funded $XX initiation expenses two submissions, the were XXXX through development in facility paid provided expansion loan confirmatory our of that Of

of which to well of $XX.X ES the were XXXX the support in million commercialization for TAZVERIK commercialization our included as indication, to for FL expansion expenses SG&A as U.S. for launch the initial infrastructure and the prepare build-out

of we robust As a we XXXX, expenses year. ahead, look impact planned activities the have which will our for for set

approval for for We $XX expect this operating Eisai FL and million expenses million between in million. to to then for year. payments $XXX GAAP approval milestone ES TAZVERIK be anticipated includes the This and later $XXX

mainly for confirmatory is tazemetostat. million R&D Importantly, and million, ES a expected our post-marketing between lifecycle in SG&A. our our is operating almost evenly year-over-year $XXX increase of of to of greater two which $XXX The trials, commitment the and and cash R&D expenses reflects component expansion be advancement global split expenses between

several or to that by will these investigators our be conducted to academic expand We offset studies its enable us anticipate through value. to will programs partially which continue while sponsored our collaboration, expense of maximize tazemetostat R&D

the SG&A that commercialization for TAZVERIK expenses, organization to in studies. ES, and supply as drug to effort with our result the and an the Our for increase launch the expected inventory also expenses anticipate of launch ongoing and of up are support clinical our XXXX we'd discussed recent increase scale see the in the FL. for manufacturing anticipated continued of We commercial a

cash not of with that a foreseeable the in We include financing milestones are Pharmakon, does partners research we in financial This operating runaway further current facility our the the sheet. do least We balance position bolster of not to to and credit achieved and equivalents plan well-financed our future. an pursue stand all plans today which our opportunities XXXX. activities with into may need cash to see support great equity through business development expansion and at any be and

I'll back Rob. to that, over With the pass call

Rob Bazemore

This exciting we Paolo. remarkable indications. a a XXXX execute on of to distinct you, we TAZVERIK a start as year, have is commercial is number two Epizyme of including time this and vision. milestones two off Thank for roaring our launches in

We for I'm range also that continue to options meaningful meaningfully have our deliberate our its but tazemetostat, serve new a and in strive ambitious, as we these impact we believe value cancers. execute in for to goals may confident potential to ability of the to create plans for we broad so shareholders. strongly meaningful patients expansion

us. we'll line joining Thank open Q&A. you all now for the for And

And from comes Mohit Citi. first [Operator question our Bansal with you. Thank Instructions]

is line open. Your

Mohit Bansal

my Thanks Great. for questions. And progress. on taking congrats the

Rob Bazemore

Mohit. you, Thank

Mohit Bansal

Great.

well? treatment numbers there talking in the follicular divide And market, provide strategy about kind of side. questions we many here? in what's slide opportunity How initial lymphoma? your behind first-line, increase. the from for you which patients for would couple label about are So, third-line of some European as the market us have -- number XX, you'd how you you my On kind Could of do the talk second-line,

Matt Ross

question. for Mohit, the it's Thanks Matt.

make the shared is the to for then anywhere the that opportunity to there XX,XXX year. are XX,XXX as our be X,XXX we of And of context research, consensus setting, continuing available third that roughly each which with all is line relapse across all refine estimated that there's numbers patients with and those between population So lines treatment. reasonable With space are XX,XXX the roughly newly go In we of regard think FL goal know or our patients treatment have are to patients. to in that is now. call, that disease, patients first-line the insights we've the course TAZVERIK is we refractory that roughly we the think as diagnosed through right that line there out we're consistent specific in third between to patients

Rob Bazemore

relapse we first-line know, beyond Those to this is as most rounds its But treatments that's patients XX,XXX eventually XX,XXX Mohit, cite slide. ultimately, therapy. most non-curable, therapies that of on. they're patients are number on incurable continue disease, We think we through to a of those move that to do patients move these the an who they of because the multiple

Mohit Bansal

European it. what in then, of terms Got plans the strategy, are And there?

Shefali Agarwal

the So, this hi, in terms of is -- Mohit, Shefali.

strategy, terms wanted on align FDA. to the of the European just we In

you date sNDA PDUFA an Now that of XXth with accepted NDA a as been our as we -- know has June.

We European are understand engaging our in -- to authority engaging plan. we process in the are regulatory

many also advisory to conducted forward Europe. the have path trying We understand for boards and

Mohit Bansal

be differences? -- ask eventual cancer As their -- your do are how or learn if it. Got from there may cancer. molecules Constellation competitors we which What well on How data could can program? thinking prostate one are as prostate about you that has And in I own some your the differences seems at least any for you in side, opportunity? like more data

Rob Bazemore

the pharmacodynamics the us about know lot just One we administration gives the differences PK talking start and I'll things I'll we that can bit the we're Phase is what as Mohit, to They've it's we're the this. thing we study that a published Phase specific want hoping stage three help with day in earn day. a we the about about from between not into of learn molecules. component. the next about like drug things just terms about inform to a differences There insights of to their the X the compared But that. component let times and talk that before move Shefali doing a and way Shefali the talk Yes. that go molecule twice just will the into X through are

Shefali Agarwal

portion X portion. is the the So phase safety

So dose. we enzyme to and both and would the abi be combination studying trying understand

biomarker, to also markers and collecting once biomarkers will move PD that then what combination portions. with population, work. specific be would the to retrospectively we And understanding the would efficacy we preliminary at looking randomized the We have understand and

So second to the have guide help we will the and study. randomized portion us of part in or go data which that the want population

Mohit Bansal

Good. Helpful. Thank you very much.

Operator

Yee Thank Michael have we from you. And Jefferies. with a question

Your line open. is

Michael Yee

and that's know, question. the Congrats progress on pregame for you while into hard I bit of obviously it's Thanks on the ES a guys. lymphoma. at are all a Great. follicular important work guys the launch

transitions how follicular now then of also label, evolves Assuming where expand perhaps that importance community are? of sort ES transitions, broad approval centers, as patients. strategy you the there's or of in And could cancer where you what a patients to a to maybe if lot and big a lot follicular to how targeting the maybe to mostly talk centers are the

to it big talk in versus the communities? sort just and of maybe how centers evolves of a follicular in dynamic launch So,

second quick one mentioned here. there's I of just lot -- a know guys is question indications then, And you different

Is you Phase is data? cancer. it data year any Of we the data we get? you. could should Is guess course, that what this prostate I maybe DLBCL X get this just question attention prostate what describe, could Maybe about data? last just that pay if Thank Can we year. to

Rob Bazemore

Mike. Certainly Yes.

we're as evolve level. FDA a big lymphoma other. that starting the to start as At year the speak accepted high this And commercial launch a on follicular along me way as on very those have is big strategy, that's they pleased NDA can I'll going milestones lot of then Then talk high a about trials Shefali and move sNDA. the the data. at stage let from let FL. also really to Matt we'll into level This really we but strategy studies, the the how for one the to So a

always number would be would be would been that that such much that the follicular would pull a the would in launch review they had be And review. help of for cross-referenced help, it the hoped us review efficient plan achieve NDA, that that we ES more Our earlier FL the time -- be -- and in lymphoma. had modules with a

We've named achieved exactly supplemental with NDA. officially that being this now a

So our in PDUFA is date June.

pleased very we're about So that.

is think in ES. Those I other now. of to a the with launch place that Many with the drug of patients right first the one. the positive help all experience programs put the that we've doing access, patient things is are we're ensure

a the always are you solve As little for and is hiccups with there streamlined. find sure we're make having opportunity everything you to launch and bit the those expect that

the So if FDA. approved, by that approved FL by is it's time indication the the

those then easier there. get of much things and All are if in makes quicker place. access It we so payer

about the the in FL a the how always launching prepare of strategy changes now FL first. changes we I'll organization, Matt an we're from the and for how epithelioid evolving beginning, anticipating was the which a bit commercial as it approval. was built talk sarcoma So that strategy let of part launch, but how

Matt Ross

Mike. for Good morning, question. Sure. Thanks the

disease community point setting. a follicular out more lymphoma you As a based rightly of is

time field-based of given fact year structure were FL completed past, for that the With opportunity the be to the XX our talked ready market we've people that, spending sales epithelioid of the to community that around be the in hiring. pivoting all force responsible patients, get we'll as we've the in to the practice setting. around was to ES more regard this were for ultimately have institutions roll sarcoma those going managing So

organization sales our So, expanding. be will

the PDUFA all that coming the our actually organization on of talented identified date. prepared to -- to advanced well board be individuals share join we've that XX hiring to in happy We and be will we're have completed I'm very of

filing, preparations. the has able the which Rob that's relates mid-June. as ES our that we've to given But be accelerated cross-reference it As modules other ready fact to to we we've the want is FL referenced, in why been

will So these high a community now team are based clinics where in treated. community to the the in patients volume field accept position these be

Shefali Agarwal

this is Shefali. And then Mike,

question Just in the answering your terms data. of

the trials of this is have to our execute and So, trials, have and as study. FL studies studies well focus to as second-line, the these these including two, the the ES on the that completed as prostate other safety ISTs do, and the ISTs trials portion confirmatory of starting we we especially in Most year company-sponsored definitely well trials. will as

year. study. So have efficacy we of And expansion the of expect later then the on moving to portion part to this

guided not on have part. We the presentation

all when be submitted. it will on We complete dependent studies the and when will be

Rob Bazemore

I between strategic of part think the level with that, up other wrap of all higher Mike, and So it answer. that a sort I'll

activity for which is in The increase in All of development the follicular commercial TAZVERIK we also work what launch to believe ultimately adding patients. of value value we the the described both to our the to to very but expand organization to prepared important, to be company, lymphoma.

which the we've into that runway that -- baked of describe now is XXXX. is into All at Paolo least that

we We with beginning at had the that Pharma just this the option to year, Royalty fortunate be able to close year. the of put on were

And so that extends further. our runway even

company. least is And at we runway a into so our XXXX, now as become commercial

Michael Yee

Thanks it. guys. Appreciate

Operator

Thank you.

Our next Lebovitz question Morgan comes from David with Stanley.

is line open. Your

David Lebovitz

FL type very of in of look into you much population? on Piggybacking going taking What trajectory setting. going When you the we towards into last thinking my be that potential question. Thank launch question. should and community for the

Matt Ross

have in lines about and to the particularly is who follicular relapsed failed refractory course mean to high the I level think with of therapy. need living those that's the I of first Good thing morning. and of for the setting related unmet think lymphoma, patients two are prior that

that can balance The being actually fragmented of with about -- PIXKs. actually well, opportunity fact are are clinical roughly that the it's actually a of -- we trials. label third with the a is marketplace So patients can say with chemotherapies treatment we highly speaking treated in recycled off therapies,

seeking the physicians in there very you we because TAZVERIK when the look the meaningful the the these adoption least drug attributes profile that be is of are response it's the later that duration the confident So, show year of That line and approaching meaningful safe. a with that's effective. are those will rapid at are setting. associated is that Again patients that at and

think of we uptake, wild mutated-bearing meaningful see uptake patients have both believe when approval. right that the certainly would the about population segment and So upon as type that well as we we'll we in

David Lebovitz

Thanks for taking question. my

Operator

Thank you.

Rob Bazemore

to maybe one that add comment. other just think I to David

that benefits David, we approved even made that the and -- epithelioid patients observation just available the access coming of patients already not of epithelioid sarcoma, lymphoma, for of tumors. follicular hotline for I seen other verification Just my remarks we've sarcoma, opening been also as benefits who have verification seen the that types for in have we've in we've the but patients to well seen in as for we've ranges time INIX-negative that that with

David Lebovitz

you. Thank

Operator

And next Oppenheimer. from Thank Gershell with comes question Leland our you.

Your line is open.

Leland Gershell

in other challenges know only seeing terms these it's at Thanks. in and to into? reimbursement run taz Hey, lines approval the And I use good Which other based this also to just we Thanks see some curious of the morning. just tumors, ES But use already actually FL, good early question. taking on is of of taking And what to in patterns seeing? therapy? in which from know my point. are I ask question, the for the last of days you've you're progress. any settings. want that combinations the

Rob Bazemore

actually Yes. get I got very couple first with Then that But think a see verification of second-line early. Matt very the benefit was was follicular It's We're we approval right. to a specific. a is I point after who very your the just launch. I'll lymphoma. weeks had patient into start interested of more into level. the high

drug weeks. look that indication available. more speak might what I'll I So what is like early we've Matt in bit an the adoption now seen But of was about commercially few think first little as the let it is a days.

Matt Ross

we Yes. on February ES, on moment to mean, regard so, with referenced pleased the product the Xst. first we're came I the that really prescription to from approved as was call

what and enthusiasm a there's of able for it population. working field-based our the TAZVERIK sarcoma been So to epithelioid is be team will provide the treaters, actively ES with lot and around

role certainly spoken of in As past. for an Rob there's need unmet follicular lymphoma the inquiry we've been reasons in the TAZVERIK the about mentioned, about

this we going approval in so the that's to half would second of only get And as continue first we year. that later to the anticipate closer

Rob Bazemore

I We've Matt where our had the of been week the we a said first was sure and as days remarks within XX opening approval prescription goal in make the pleased. initial we we're to -- to patient. his mean already following within had from time we drug to of We're is big sure had And averaging make we that we're of for shipped five one a to the request get metrics the that that. trying shipment. time when to days available

Matt Ross

We've with We're payers. any -- the with a just we're adopted the the to the execute which community. a continuing pleased the on very payer follow-up the performance formularies and plan. and with challenges And in they've challenge had not just TAZVERIK against speed into

Leland Gershell

asked. we But been cancer first in This for might Shefali. the prostate That And a of the have Thanks. helpful. Thanks. the prostate? quick reveal in studies from terms may see data when that's question just

Shefali Agarwal

to study, on the enrolled of the planned is the randomized safety of is have actually the study We to study the portion study. terms of the ongoing. year. safety And this So, moving portion We The patients. be study. completed in proof-of-concept in

to safety So we the data. we or hope get would would expect

of the guided data. We the haven't timing on

Leland Gershell

taking Thanks great. Okay, questions. for the

Operator

[Operator with Instructions] Werber have you. Thank a question from We Cowen. Yaron

Your line is open.

Unidentified Analyst

just [Indiscernible] few and Good the in I for Werber. thanks have morning. questions. questions. Congrats quarter This on the is a for

show the for rate run OpEx -- XXX. the R&D years? the think XXXX for for the And understand second the in you you. first-line or to about your trying we are you question. to the help for Can SG&A? what in additional second-line also terms R-CHOP following you is think us by to about help How Thank RX shall to as the question adding FL? us OpEx, Can First guidance in taz and of or XXX benefits

Rob Bazemore

address can the your having question second. then address by Paolo start I'll first Shefali and

Paolo Tombes

morning. good Hi, Yes.

of range just that are So in announced and between OpEx the we we $XXX expecting million. morning terms during for a this this $XXX year call

not the year. for are We direction giving following

And the management. launch. I SG&A or are the force we lifecycle and continuing an up think the for trials to FL launch field expecting building also inflection is the a R&D confirmatory ES there because the mentioned this quite also organization eventual and year point we for as the

we beginning we cash years. way the our year and assume But the the year for at directions these these with of this we So guidance for at gave with also run XXXX. position in least not following are giving

Shefali Agarwal

are standard on This just important your second-line. up very going care defining to following on RX the the question terms in strategically us in you the of then why regarding I study. know we study of has RX, doing think become was as And

the was plan to Our in lines other move with expansion. actually label

line So we DLBCL data we in really believe based activity. evidence is do the and able confirmatory is important trial trial combination lenalidomide. RX with plan show to a on that It we to combine preliminary R-CHOP a we second are were and preclinical and the the in that combination, because that have with was

doing look very are have and interims an at And adaptive so, opportunity design. a to where different we design innovative we adaptive

Our hope with compare additive in RX. with to provide combination RX and then it RX our to benefit

have of study. a also We the portion maintenance

profile As important really study you I patient be in profile that of benefit we continued because would would because know benefit, third-line and safety progression, that have believe for add shown the we Matt in of illogical And and that beyond continued progression. maintenance we about, been this beyond and the that and talking have us. believe

of In second on terms question up with your R-CHOP. following

R-CHOP. dose patients the in DLBCL combination in presented we have combined XXXX with ASH tazemetostat where R-CHOP and at we We showed high-risk DLBCL, could full that

patients FL. well, an with that you in front-line FL to are we high-risk used so R-CHOP because And know going as arm is add as

combination And actually with our R-CHOP plan FL tazemetostat line value all of of in to RX lines beyond. approval frontline FL, so, across provide and then third-line starting is in and second

Unidentified Analyst

helpful. That's you. Thank Okay.

Operator

turn am no for further this you. remarks. the I'd I Bazemore time back At Rob closing Thank not questions. any call showing to Mr. like And

Rob Bazemore

your and for you questions Well, today. joining for all thank Okay.

to Epizyme. you As and you exciting how year. ahead this the heard, this this enthusiasm for for everyone. for is support, Thanks We're a off forward many about we're year incredibly look We the exciting starting milestones your thank year. we company time

Operator

call. this gentlemen, participating. for conference today's Thank concludes and Ladies

You disconnect. now Everyone may a day. have great

Epizyme (EPZM) 24 Feb 202019 Q4 Earnings call transcript