EPZM - Earnings call transcript Q4 2021

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Operator

Hello, and welcome to the Epizyme Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the prepared remarks, there will be a question-and-answer session. Please be advised that today’s call is being recorded. I will now turn the call over to Kristen Hilton [ph], Investor Relations.

begin. may You

Unidentified Company Representative

be This a operator. and issued press at release a year of Investors Thank company’s the update morning, in providing website can press That business financial quarter in addition release the XXXX section you, epizyme.com. results. Epizyme found to full fourth

Treasurer, Officer. Bogle, Corporate On Executive Chief and Vice Grant CEO join Joe Vice Epizyme; and President will Development President Beaulieu, call and the the are and for of Controller President Medical and today Q&A. Dr. Agarwal, us and Shefali

views Risk As related may a recent most certain and These are to forward-looking to described reminder, the this views today’s representing of XX-K would turn as Factors XX-Q, call this represent results SEC discussion Forms the factors, call of as to like materially Grant differ Grant? time, will we expectations, section other over as no statements to include statements important of any and risks subject filings. Actual those should upon various plans statements. our Epizyme’s Bogle. our to uncertainties. and At due and current be update including date, which in these undertake forward-looking relied our I not to and publicly subsequent obligation

Grant Bogle

and for EZMXXXX, insights investigational guidance Thank results, our quarter XXXX. to more for company in you our development performance speak full and to good review commercial business tazemetostat year our position and cash Shefali of TAZVERIK today’s and updated you, Kristen results. I and inhibitor, additional progress on on SETDX morning, with will detail. provide will commentary, clinical fourth [ph], XXXX great be to update here and everyone. It’s our provide call, including an On

line Following our remarks, will the for questions. open we

compared quarter sales third-party of $XX.X an clinical fourth $X.X million, $X.X net commercial trials. TAZVERIK of for million, During representing net commercial with the related revenue approximately sale the the TAZVERIK quarter, increase TAZVERIK million product for company including third of when use pharmaceutical to we of of quarter XXXX product the were XX% reported fourth in XXXX.

December our for goods XX% approximately year of XX% ended million and quarter quarter fourth product the program increased of full XXXX. XXXX TAZVERIK for XXXX use end $XX.X commercial of by the XXXX in sales. the third third-party commercial from Free the $X.X sales increased year million. trial. company reported in patient driven represented sales the year lymphoma demand pharmaceutical Total the for TAZVERIK related over TAZVERIK were For product fourth the XXXX, to approximately quarter XX, XX% million, revenue clinical user net level, total including demand $XX.X net for full full of of assistance approximately patient end-user follicular we primarily

to patients data as commercial studies, significantly believe which drive on physicians to matures. among reach efforts to monotherapy, and the TAZVERIK our well value We advancing as our a we growth expand have and potential of progress TAZVERIK, as for continue as make prescription combination the clinical the

changes operational We’ve release external by impact highest As workforce be we while extend the cash all that continue to expenses approximately our we and we for resources this areas our with its company runway, our a our the XX%, necessary deploying make reduce to announced morning, press to in our spending. reduces plan stakeholders. believe to and strategically implemented along

discontinued have studies, pipeline, a reprioritized in also effort, including and enrollment SYMPHONY-X our we this As of part select EZH-XXXX.

handled Their transition appropriately today to to employees mission is Epizyme being the I the advance for numerous our company’s for want smooth it review studies other of tazemetostat and the are to in contribution Shefali impacted in therapies and to combination their detail, through all with solid that to investigator-initiated As efforts as continue and recognize ensure tumor that cancers is vision. and company-sponsored as hematological we our being both study will company them ongoing possible. studies. thank from

and For commitment transforming and with changes stakeholders the benefit those also with support, Epizymers TAZVERIK living who vision designed continue of I the the initiatives, helping establish advance cancer in organizational last remain and their to operational patients as and company. along joined and foundational them the implemented the focus as therapy streamline of to our we with CEO when August, organization and are as other for thank lives company, FL of cancers. These our of wish I a to the all future for

to of TAZVERIK to XXXX, systems support ahead align of Looking continue plan care to to monotherapy. educate to and providers growth we the

forward making as year. Shefali, further important providing global well SYMPHONY-X on like trial to study as Shefali? the our the now these with in the X key our activities of study, including near-complete portion to progress turn our this we study, I’d clinical and advancing over the are Phase look We we program, development will call initiation pleased our speak enrollment of throughout the programs, While to progress. in making we other cancer Phase LYSA in are are updates development programs time, prostate to X the the who the At CELLO-X. clinical progress

Shefali Agarwal

Grant, good Thank you, and morning, everyone.

development, have tazemetostat SETDX we of our molecules now EZMXXXX, in inhibitor. SET-XXX and a novel initiation the clinical With two study,

I’ll quarter, with key pipeline. fourth our begin across development progress we the During tazemetostat. made

As tumors. of hematological we tazemetostat discussed, and have has other FL to that potentially previously therapy solid become backbone and in the we malignancies a potential believe

Our variety and other been when combined clinical development and both with across tumors, built the aim with monotherapy as demonstrating of therapies. hematological the utility has of solid a clinical tazemetostat program of using

beginning work steady of and a several to XXXX the mature, forward look that and to excited that years we much of in are ago began data We stream is beyond.

which open the data very in XXX have December, of we the pleased the tazemetostat clinician, report for we a period to portion by SYMPHONY-X waiting Annual for disclosed the specifying FDA and in completed study milligrams as Speaking December, in allows twice to the to that at a as submitted ASH the protocol are Meeting the the U.S. encouraged us daily randomized amendment I’m study, we the dose

the reminder, Phase been of lenalidomide, years, with patients refractory rituximab had in have progression with the RX evaluate rituximab therapy, tazemetostat XXXX. study within experienced a with call disease lymphoma, in will who refractory which relapsed combination least who two one As are for previously we at and treated those portion follicular X including systemic and/or of

are Greater We global partner, with HUTCHMED. start-up our activities, in in including actively sites China, collaboration engaged

the patients and expect Phase quarter of portion to patient the We the are screening first for in first XXXX. X enroll

approximately to globally. XXX approximately We patients XXX enroll total expect in across sites

XX year. portion of Phase Xb the follow anticipate to run-in study longer-term medical and at to data safety continue we presented patients conference addition, the this be in later a the In follow-up

interim the We, evaluate XXX LYSA of from out now The XX, patients in XX study. FL both primary patients, which high-risk the tazemetostat of in presenting in DLBCL with in of LYSA, cohorts. And R-CHOP. enrolled DLBCL FL patients is in nearly combination study enrolled study Xb/X Turning with of for enrollment study, DLBCL have out arm endpoint and study to XXX the response results with conjunction study newly rate anticipate complete to patients in is Phase in of the XXXX. is as complete combination and FL arm. XX tazemetostat R-CHOP is we Phase for the FL the DLBCL of or diagnosed February This a and X large a

XX% enrollment Moving to approximately is solid tazemetostat The castration-resistant Phase to X from an is to compared randomized interim portion enrolled the study We half toward presenting and nicely. second our and XXXX. a the CELLO-X, tumor prostate of metastatic evaluating patients of expect the safety we randomized Xb/X monotherapy updated the plus XX portion PSAXX patients, the open-label progressing program, data, anticipate study in the target run-in study in Phase enzalutamide enzalutamide and cancer of complete in PFS XXXX. radiological completed portion from including in data

recently tazemetostat tazemetostat diffuse initiated of finding basket and of various hematological and study, safety, multiple our EZH-XXXX and X/Xb basket also relapsed/refractory tolerability B-cell to large potential activity cell signal with hematological with mantle of designed FL, malignancies, patients specifically Phase myeloma. signals lymphoma, investigate study, combinations lymphoma We

for for lymphoma received use antibody evaluate cohort entered follicular have Roche’s agreement combination with engaging provide mosunetuzumab, the have a cohort plan We supply as EZH-XXXX. We investigational in therapy. on at of T-cell with will patients lines Roche tazemetostat This prior with CDXXxCDX it bispecific who into of the relapsed to enrollment investigational EZH-XXXX, clinical refractory more milestones. least bispecific key two updates or treats of

preliminary from half provide second in data EZH-XXXX We plan the to of also XXXX.

programs. as reprioritization announced mentioned, Grant of today, Additionally, our we pipeline

setting, plus market decision breadth combination and solid evolving well of Epizyme’s optimizing other dynamics these hematological we enrollment who Given potentially continued development as clinical well for the is as tumor ongoing SYMPHONY-X, the already with to made which in to have tazemetostat investments two company-sponsored studies. follow have discontinue including was study. will in study patients studies, program, eliminating continue on decision The focus discontinue in investigator-initiated development committed EZH-XXXX, studies, therapies these both as to tazemetostat study. combination on the enrolled overlapping based We The in studies and basket been in of of rituximab tazemetostat third-line the the and our malignancies, to remain the studies. current in with company solid both as tumor

inhibitor SETDX oral EZMXXXX. first-in-class novel our to Turning development candidate,

We adult patient Meeting. patients study, SET-XXX quarter, Track shared key in along updates, relapsed/refractory Phase our study B-cell by expected and myeloma trial diffuse the and Phase the X/Xb from FDA study the first the in plan EZMXXXX preclinical preliminary in X/Xb designation large drug as orphan study to designation provide XXXX the XXXX. multiple been also with by along During DLBCL with FDA EZMXXXX have on EZMXXXX the Annual data initiated granted ASH myeloma. lymphoma. of we multiple milestones design enrollment granted Fast for with clinical has relapsed/refractory adult reaches at data We safety SET-XXX

and see, well yielded its drug The need as the develop potential given At be As advance in the a we inhibitor. multiple tazemetostat cadence continue we I’d high like development and years. you ES, to coming the back program EZMXXXX important, a of SETDX for expect and addressing myeloma Grant. this and a FL to beyond pipeline through as call unmet data potentially with as to steady will DLBCL tazemetostat in pass time, data can

Grant Bogle

quarter net of cash XXXX, ended extends offering cash, January quarter runway public XXXX. earlier, December million ended as stock. were XX, the proceeds our year and an We fourth cost expenses additional reduction and outlined the XXXX. into million XXXX the This measures $XXX.X $XX.X full and million ended in million million fourth in Shefali. full well non-GAAP we for XX, the Total Thank equivalents $XX.X of In raised $XX.X fourth with operating of marketable year as XXXX. common you, for securities. a raise half of December were GAAP $XXX.X the Total for XXXX expenses quarter the operating back adjusted $XXX.X the for million in

potential, pipeline expand today, by revised include portfolio, TAZVERIK’s and pillars organizational between January operating expenses continue strategy. maximizing $XXX as measures be of our our building million our all and of our the year to at from patients have today. collaborating value. guidance In operating We as and million that a million to operational These perspective, total We of commercial closing, both this to XXXX now non-GAAP compared activities prior full a to development reduction finally, guided to adoption to and an the discussed building emphasize expect discussed drug and operational pipeline I efficiencies expense XXXX clinical $XXX $XXX to four million due in and expense well reach TAZVERIK, to want guidance on expanding the year. the perspective, of incremental $XXX disclosed

and decisions questions. are progress for we to yet on open imperatives. operator, to the the difficult forward I’m corporate come making the to ensure can growth With made pleased but We year. look you line necessary our this help by and that, deliver progress that now we’ve may

Operator

comes Thank with Instructions] from Cowen. Joseph you. first Thome question Our [Operator

open. Your line is

Joseph Thome

just of one taz the morning on the you Maybe commercial taking for setting. Good in question. first and thank terms the

maybe now, maybe of in longer the that sort launch, set drivers are As the in compared paradigm, determine kind over different year, patients, how to kind a is will out? next using key increasing you sales? right of drug earlier that as physicians treatment what of And you’re are or shaking duration of, it the look for the seeing

Grant Bogle

Joseph. you, Thank

as changed and that answer I continue want hospitals engage. execute open a in the they So laid to plan now providers seeing to to question, which is we to result to means on focusing fine. engaging many steady we’ve out, mean, And the terms used your in has way, engage that and healthcare and of and want I’m in a clinics really of more that with progress. digital be the pandemic that on

parts However, and we forth are country, seeing clinics, open of in up. other so the

with adjusted And associates new we’ve strategies have on of as systems brought reality. on organization So our we’ve that we’ve that skill sets to more align into previously, talked delivery. the care our side

and are systems working wants and, settings. TAZVERIK to prescribing that in by ensure with patients label appropriate sets within to that easier it’s for a if use really so aligning So these we support to according order inclusion leadership to that, do for example, provider different

we’re continues and development continued about I going our growth – sales our that. continue talked So believe, move obviously fair the lead forward the to program and All clinical a will within have of to, talk label. those and drivers current strengthen to to position while, amount

about because – that can’t but clinicians of promote help So on future that what attend the may so TAZVERIK again, – we that that meetings would that potential excited and forth, it be. I’m inform not does information, promote medical

Joseph Thome

kind better that of, is how in studies in for follow-up, just it this you success, the a care for of TAZVERIK bit into more just decision? of current But based of one terms other on is think do discontinued, Is standard kind basket you – but Thanks. evolving? went And the ongoing. of I into of tumors the information probability Shefali. was probably what can little solid Or suited then is Perfect. guess, maybe, a decision? give one

Shefali Agarwal

Sure. Joseph. Thank you,

potentially want So in the dynamics. of well reasons investment reason to optimize marketing the these to discontinue the as one terms the of were – we our M&A on toxicities. big – as also based studies, changing is studies – It overlapping main

in PARP in have solid combination remember We those was PARP. that indications. basket tumor with If you the IST study, that an do are combining we

tumors is goal because That’s Overall, will data in once a important, to that cancer and in as and So know we’ll that it we have next trial well. And steps from with get combination our get committed combines, solid can about able be to think data, and are both the that IST. be TAZVERIK. we starting we malignancies study we very different why that prostate actually heme PARP. with how

both we are that committed So we believe and and solid to heme that malignancies. important, TAZVERIK is for

Joseph Thome

Perfect. Thank much. you very

Grant Bogle

Joseph. you, Thank

Operator

you. Thank

comes question Lawson next Barclays. from Our Peter with

is line open. Your

Peter Lawson

Great. Thanks taking for the questions.

Just And What’s thinking duration about average where revenues. get the could the of it guess, you I of tazemetostat? the year? think use do end by of

Grant Bogle

in So Peter, general and quarter-over-quarter of data what that, – it One we’ve It can the I is, mainly, is two not for And that guided here’s to duration would is that past. a increasing we use. say reasons. expect trend, matures. in the

them, obviously, on So the more we follow of therapy increases. get we the patients that the taz long and duration

answer earlier in do a of use second of third-line use use tending see you trends market that asked the Joe, studies, and but we’re are We the forth. but is of to question see press, do in this it trends therapy. we today. we trends our sorry, in the our albeit, use Most directly where studies the small physicians ATU second tracking this guide it, is didn’t I seeing lines setting, help line even projections is us within do portion growing taz – The so see shares, when

So those as longer. we would expect on patients earlier to lines treatment, they move would stay of therapy that

in journey. a trends right the The moving So direction. it’s are

in would not I believe time. it we there’s continue period that think for of no direction that – a would we And so reason

Peter Lawson

for can study Should for been then a around showing potentially particular guide where that activity question beneficial us that’s a you that Shefali, down. tazemetostat? us of of read basket shut really And help benefit tazemetostat? the from Got you. a we sort Thank you of into you. indications kind kind see to aren’t Anything

Shefali Agarwal

Yes. Peter. you, Thank Sure.

terms I heme preclinical tumors. in on both combine data, TAZVERIK in of and action, we have the solid mechanism So presented agents, think and looking TAZVERIK, of of right, many based with some we believe the at can

We And that solid have abi doxorubicin tumors, then in RX, with job. and have in that with well shown in prostate. in enza have we as We’ve shown combination shown malignancies. with that shown we our with heme

In is and more believe And I as I as other that’s that – ongoing heme terms have well. was of that an an a the ISTs it as overlapping what enrolling would irrespective? in optimize study in on do combination, our basket well based there’s from we to mentioned, study potential if study, data there data how how we I studies would we combination we patients effort get is and development. prostate And in indications. of that an study why, our But that get that with as PARP both study,

Grant Bogle

well can is underway, the a we especially plus, solid the if mean, add look Peter, – if streamlining as, where really in the the take at of way, but basket done changes removing it I The of which been in that the what to layers use in significant. important appropriate, really expense with tumor our single-agent we’ve management Rituxan guidance think, really away. the us for are might have in excuse things the certain because when not efficient complexity, made operating I SYMPHONY-X. those me, this Then is data setting heme the more to drove also phone removing that simplifying quite you I study on of get involves third-line is, some organization, frankly, goal as

going In fact, it’s down.

we’ll no should out We’ve forth. read taz’s that terms to potential with we’ve trial way most So X we’re a area not was and but on prostate we solid large CELLO-X, viewed, there, efficient the so not felt be about Phase work underway in got tumor and this especially of in excited in that decision continue got other underway only that ISTs the cancer.

So bit a more I perspective. hope that little it puts into

Peter Lawson

Great. really Yes. Thank you. helps. That

SYMPHONY-X, this that year-end update get that we year. Just a question. data updated about? on be Is We kind of final thinking should

Shefali Agarwal

know, So in portion and safety as ASH know, in in line last of the terms study. of the year SYMPHONY-X, run presented we it’s beyond. you that second And as you for data

we’ll those provide and patients this So we follow year. to continue data

provide as the the of portion haven’t year in really to this for data We on continue study. run we’ll the SYMPHONY-X matures timing, in safety conferences exactly guided but for the

important to the Peter, that and clearance think the that the XXX well. amendment as portion screening I in is, we in Phase have part protocol study X gotten patients is in I milligrams submitting randomized start-up the for the of want highlight of the are global actively terms study, we for of the portion BID and

Peter Lawson

Thank for Thanks Perfect. updates. so much. the you

Operator

you. Thank

Our Yee next with question comes from Jefferies. Michael

Your line open. is now

Unidentified Analyst

you Thank This on morning. good two I I our questions. challenging Yee. in for Hey, the company move to is taking And for have [indiscernible] forward know Michael environment. it’s questions. this

be The EZMXXXX. first going to on is

study. to And be myeloma? that forward? And the DLBCL guys the you pleasing then do bar what’s data you’re and should do for move multiple first-in-human the What expect in will study be good initiated looking or You those responses would in be pathologies? expect you two that fully

Shefali Agarwal

Yes. Sure.

reminding are for I where So kind just EZMXXXX. mean, we of

myeloma we As part We study initiated multiple our will both you of in are study first The last we and know, year. DLBCL. where study. the the dose in-human starting escalate escalation

we activity the to patient to enroll goal then that hope and and safe to are into especially plan The we dose in once biomarkers. like evaluate, is very this have get t(X;XX) We cohorts in translocation. year expand to to quickly. portion a would first that is patients And in-human preliminary we get the dose, a where screening

showed need at unmet some We myeloma, ASH last specifically is our in a which which myeloma. preclinical activity have multiple shown year, in t(X;XX) data big

the And could portion registration so biomarker, to path study. evaluate goal for that which our faster that is in in a of particular be

myeloma biomarkers look at DLBCL as looking look that. as well at things we non-t(X;XX) multiple do like how at if we and Additionally, a

and safe if get myeloma dose, needed. So a which eventually for evaluate is DLBCL is goal expand the then us in to to and

Unidentified Analyst

Is had had CELLO that? we to Could Great. at when can that more at little Thank bit can that guidance be then going you point as you. Where data mentioned we Okay. at XXXX. in expect give be from expect that going a some And ASCO? that? you updated you to GU a Is Conference?

Shefali Agarwal

terms just the we status, for the of the patients had in So the the safety XX presented last ESMO data run at CELLO-X, in year.

patients, progression. those to including PSAXX, We continue to time PFS, follow radiological PSAXX

is to that second Our half this goal of data year. provide

have of as the is goal Additionally, Phase the of about portion the patient this well. provide we XX% enrolled half X data also to that mentioned we some year study, interim randomized second our

have So timing on presentation. as the of as continue enrolling more the – we’ll patients, we we more that guide follow-up, timing further

Unidentified Analyst

Got one you. Thank last just small question. you. And

you that Epizyme global study at that enrollment? was given to HUTCHMED. payments mentioned Were You the collaboration X Phase any in there initiated of with milestone start the

Shefali Agarwal

No.

Grant Bogle

ahead. Go

Shefali Agarwal

So I activities, process sites. of in we are in start-up activities, of terms both opening globally think of the in starting terms the

And trial. our are and right big a the it’s up, know, sites you is now. goal get to patients it’s about we As screening –

status So to that on China in U.S., Grant is but both of me globally pass milestone. terms let and in in the

Grant Bogle

million was X are we’re at agreement. right that of where China, which that. the in received Phase payment, the further of terms and working now. assets And and at we that really a occur the global remember, signing commencing also, But that’s So start-up upfront we’re $XX expense of would within milestones of collaboration, there on upon

Unidentified Analyst

you Thank for Wonderful. questions. taking our

Grant Bogle

Thank you.

Operator

Nierengarten question Our David you. [Operator Wedbush. Thank next with Instructions] comes from

is open. line Your

David Nierengarten

for I two. thanks taking Hi, questions. the have

of the kind convincing in interim for Have you just maybe, as if or remind of look of you discussions an that lines or surveyed then on had for would folks response us had you planned increase be therapy? a – acceptance earlier off, with And what rate part could use SYMPHONY-X, design? trial that say on “convincing” doctors hate First would I to overall LYSA. but Thanks.

Shefali Agarwal

in frontline terms of is the you high-risk LYSA, DLBCL and first this question in know, FL So answering trial question, a patients. your first David, as

we trials. look endpoint, of the terms looking In at rate at CR in normally upfront

to data is And and rate designed in so how trial. the between about have CR published on LYSA, with the XX%, XX% based the we high-risk that’s DLBCL

So is the goal to enroll.

know, in enrolled are completely almost that we you enrolled, As trial. nearly

is And talked to high report on get and goal because to have database that. in patients has the – look data are we So who LYSA a able that FL big interim both year need. DLBCL risk unmet to data be where they at are this and big

goal And the inform SYMPHONY-X, to is in about steps second high-risk so able the next line physicians the be In to patients planned in the regarding that question in do both data about indications. study. and think interims front of have the we two terms

after rate The a a response guided based and first seeing XXX about on patients XXX which basically how interim. which as we interim, is responders, based we’ve is is are futility

is interim on of second PFS based XX% The events.

the two long the agency as those have an the aligned as second and is meet criteria. So we – protocol to interim with claim we’ve as efficacy, important opportunity actually defined because you

David Nierengarten

you. Thank it. Got

Operator

remarks. other are there questions the closing queue. And turn to for in you. the back to Thank Bogle any no call I’d Grant like

Grant Bogle

and day. for coming months I providing moving Thank Joe you, again, to just upcoming the the next like operator. team like work updates dedication forward speaking We the to to in thank many our at of well everyone a week. look and to you as the colleagues great and Cowen Have entire for with organization forward. Conference and as us both, thank their hard would, once joining Shefali today, Epizyme I’d

Operator

call. concludes This conference you participating. today’s Thank Thank for you.

a You great disconnect. may have now Everyone, day.

Epizyme (EPZM) 1 Mar 222021 Q4 Earnings call transcript