EPZM - Earnings call transcript Q3 2021

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Operator

Hello, and welcome to Epizyme's Conference Call. 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 Craig West, Vice President of Investor Relations.

begin. now may You

Craig West

the This update issued quarter in press found results. operator. Web the providing at site XXXX press a That epizyme.com. in be can business addition release section morning, you, of a company's Epizyme release financial Investors Thank to third

and Officer. Executive call and Vice with President Chief is and Officer; Medical Grant today the Executive Dr. Development President On Bogle, and me Chief Shefali Agarwal,

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

Grant Bogle

here everyone. results our and strategic with Craig, to four of progress the update pillars to Thank you, you our we've plan. an It's share third great provide good and morning, to financial be on quarter made against

announced to We made sarcoma, quarter, or of follicular lymphoma, to favorably plenty believe you intend in of the right number FL, more ES. TAZVERIK, we of to last many are were strategic As backbone growth. a it ultimately CEO and joined aware, ones establish and the I epithelioid adoption have changes we've of as of accelerate and when a the therapy impact as to changes organizational We still Epizyme do. work or

commercial see We positive impact. begun have to a

the XXXX, additional revised see between and We to guidance expense on non-GAAP from plan meet of started million savings the in quarter. adjusted last XXX an remain with saving for track cost initiatives also XXXX. announced to operating impact have million We cost XXX

quarter, product X.X net third X.X on we pharmaceutical X use excludes net the product XXXX, recorded revenue the a which During a total from non-GAAP to revenue or commercial second party of of $X.X million for third quarter sales. we million a million its million in basis, TAZVERIK reported of trials. company combination In product of clinical sale

TAZVERIK assistance goods quarter, of second by grew quarter Importantly, we in in the program XX% with patient second what for quarter. primarily the total the over for from driven our approximately accounted for line Free quarter, the had sales. reported patient patient demand demand XX% third in FL total

easier test or be efforts Medical systems TAZVERIK educate workflows. strategy EZHXNow This to into individual part It our such the is EMR, as on of that in focus way and access physicians. integration to Electronic important makes and Record, an in provider and in accounts, the of was with settings, this new their community into increase integration quarter, growth among made partnering TAZVERIK During and several third the we provider TAZVERIK progress growth integrated care, both the to the accounts systems existing improve a the that our augment system-wide within of dispersed TAZVERIK volume is to their well workflow. organizations across large to and saw We've prescribing academic country. incorporated

TAZVERIK So appropriate choice. is easier our with positioned patient, it TAZVERIK when or making the prescription labeling and the consistent refractory physician is provider FL believes treatment encounters write guidelines, a relapsed a to a

treatment it For plan to patients. of in refractory example, group the in or available practices large TAZVERIK relapsed EMR, tied was recommended at the for the FL one while was Southeast, not the

or relapsed patients. positioned appropriately group third this to option decision quarter, as practice ensure was the for TAZVERIK FL the refractory a made During treatment

Educating In positioned practice will physician is consistent ordering to about importance EMR same the application systems and us the test platform test. the form within to for organizations their guidelines, our addition, workflow, priority of with TAZVERIK to ensuring labeling continue be within facilitate appropriately going that incorporate the a forward. provider decided the EZHXNow the of for

a We help patient is strategy option. treatment refractory throughout will this TAZVERIK health as assure an system FL treatment providers a the needs new option and progresses expect that appropriate considered at or when relapsed

customers or engage Our our field both, strategies to evolve tactics teams to virtually according and customers’ continue their in preferences. to person,

quarter, in field our having discussions. third resulted the this During teams more in-depth

allowed a representatives, deeper roles of field and us as upon created to called more level. our quarter, As were accounts non-physician reorganization newly professionals industry’s the reduction decision XX% August. some of Tier healthcare in other and than despite Tier Overall, our X reopened the teams engage field and in X clinics the at makers of XX%

education, physician we patients to we to believe addition In opportunity as well. directly have an address

or campaign, to appropriate that a for options. options. to respond effort shows have appropriate make educate requests a in research FL make and branded, which their impact an time. keeping we of shows around mind treatment direct physician patients highly request patients are patient requests research decisions, their top targeted empower treatment launched of relapsed to a market only FL participate therapy, Our patient to considering are the and we when refractory in meaningful believe when requests In XX% just for This granted. treatment a TAZVERIK physicians do patient can they treatment frequently make a the that But often

on kind details the advisors people living engage patient In more journey. branded My treatment are we out last their in with Blood which based FL launched on features to advocates we patients unbranded their advice on of where My press Blood provides put In release develop and program. that with for FL to they online personalized resource, that first-of-its the a week, This closely in interactive X an called decisions. We working addition a to tool education empower November have In campaign, guidance includes been tool a disease to proactively and group FL

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standard All commercial are helping lives we a in of our cancer transforming key therapy clinical from of in that trials FL combinations tumor making believe our of beginning just vision and trials ES. not indications data to treatments. initiatives To are to TAZVERIK but in today foundation solid evidence as the and other of just of and helping We potential, underway. provide and with the care with heme advance as combination great data in is vision, both are TAZVERIK to living additional pertaining and monotherapy patients establish on FL, clinical the discussed of progress important this to emerge further advance TAZVERIK’s

Shefali we're have moment, a trials last and oral with received we're first-in-human from hear strategic excited for trial for As for announced where with the the Consistent our clinical a making progress week major you'll these with to first-in-class our initiated of good TAZVERIK. plan, third EZMXXXX. we DLBCL in Epizyme SETDX combination milestone designation pillar Fast-Track inhibitor,

in development with advancement possible we to leaders making the EZMXXXX detail. our I'd At novel Shefali? as treatment to in now such progress over will vision therapy tazemetostat time, devastating important like clinic to as call more is an patients option and EZMXXXX DLBCL the As a bringing towards this for living of work for this turn multiple our pioneering cancers, therapies, epigenetic who speak Shefali myeloma. and clinical to

Shefali Agarwal

Good morning, everyone.

remain alluded across portfolio Grant priority programs our development As for clinical to, of a Epizyme. top

our request be to investigated forward to sponsor if continue clinical supporting are to all as excitement planned, own understood. studies drug’s programs TAZVERIK, we and enthusiasm The just the this continued very and Our enhances of full move to the believe regularly for received. expanded promising community's potential additional beginning potential scientific

combinations numerous hematological basket active we in patients expect and tazemetostat XXXX. advanced quarter, We trials important third be two quarter clinical in programs. received evaluating our initiate FDA solid the tumors and studies, dosed fourth first new clearance clinical malignancies, to During and to progressed tazemetostat

clinical remain safety prostate producing committed cadence from shared quarter, at updated next data the run-in clinical few the steady to CELLO-X of ESMO as trial years. have a in the programs such We from also course multiple We September. over data during our cancer of data

screening to In our FDA in for oral a The that in are Phase This DLBCL. actively first-in-human of first-in-class that multiple to today significant the initiate addition study patients. important diversity happy and our clearance myeloma are is IND have granted EZMXXXX received open is inhibitor EZMXXXX provide to designation tazemetostat Epizyme has the Fast-Track milestone EZMXXXX from of study SETDX will studies, announce we FDA Xa and also we we The DLBCL. portfolio. to portion

dive, studies in a with patients For FL. with let’s tazemetostat deeper active our of start

with excited activity to update and findings ASH the SYMPHONY-X our include December, to run-in date, Xb review. profile the the safety have is reported. data We the RX consistent run-in combination, the individual with enrolled. now of rate referred we have have X which products, We to safety with Phase observed XXX preliminary data for in submitted the duration, are important for and of plus pharmacology the an milligram. of remain with safety information respective patients the which Phase that as of at in reference safety documents previously by to follow-up data, the clinical profile consistent at XX what the safety updated described dose completed share response portion trial, To will the EZH-XXX, formally tazemetostat plan FDA tazemetostat both portion nearly trial longer and highest We even safety

fourth await site to China we include in and have of in the XXX begin preparation of will the Phase response As Europe. across X U.S., for the portion the and in portion our China from the sites patients HUTCHMED Phase FDA, the activation trial, enrolling global we in portion collaboration The X global study partner, plan SYMPHONY-X the of including the study we with initiated randomized the quarter.

previously protocol, of once efficacy part with as analysis to our we provide study PFS, discussion that FDA to an change whereby be stop of recall on important earlier an This may allows realized. the occurred. to have the X survival, our opportunity events and an have year, XX% second interim treatment You should may or this will effect read data aligned the early earlier efficacy us progression-free evaluation predefined than expected Phase include the the

formally in reached. active, Phase forward move amongst We to sites as EZH-XXXX, trial, will study provide and accrual. All as our key FL are Separately, evaluating large are actively plus accelerate on currently SYMPHONY-X X accounts, to added tazemetostat relapsed/refractory patient were is continues updates including enrollment the that planned Rituxan network recently enrolling. periodic oncology important milestones this others,

FL, are front-line once updates and sharing we potential enrolled available. fully Additionally, our in DLBCL, as clinical collaborative support with therapies. tazemetostat’s data FL backbone this study generate B-cell remain large forward to and potential We LYSA and lymphoma, to about to other important combination continue look diffuse of nearly both in or a we therapy optimistic with

XXXX approximately as median European formally XX.X%. not data XX of EZH-XXXX, would solid in study, we or FL, six-month to the in still combination to and tazemetostat metastatic is a activity evaluating and the the proof-of-concept cancer months. important castration-resistant was plan XX of reached generate July been PFS Medical as of Notably, enzalutamide the new have referred CELLO-X, data tumor XX for from We presentation presented which been next as during portion Society over prostate poster cutoff, updated indications Oncology safety Beyond part compared Congress September. data PFS has run-in tazemetostat months mCRPC, our enzalutamide safety alone. and hematological plus

potential Additionally, X and XX tazemetostat of enthusiastic on decrease XX% data, powered patient daily study of is endpoint remain milligrams of see of of six difference the Investigators and CELLO-X enrollment to of Epizyme efficacy about to already nearly patients. a PFS study having or the evaluating partial is having is months. XXX also from this The which enzalutamide in PFS patients to milligram tazemetostat’s difficult population. Phase the The a mCRPC X,XXX is Phase in and primary a enrolled. portion continue of Phase PSA XX% with the X initiated study treat Based XX baseline twice the Xb half portion one in the of experienced response. study, decrease combination

Moving heme malignancies. multiple to will to we this announce current planned of received of and care EZH-XXXX. that and mechanism basket novel initiate studies, effort tumors tazemetostat. announcement, hematological study, malignancies we expand plan with of study end. IND to study proceed, other by efficacy to potential patients basket to year in our clearance and in tazemetostat’s plan have studies This safety in we're standard FDA been of an of evaluate both for this therapies have Using With approach, in to combinations action from basket Epizyme’s and enrollment the cleared across we multiple excited therapies studies heme solid both the

advance. our trials studies to addition discussed tazemetostat all clinical other to In of continue today,

stream active tumors. agents to All of significantly and quarters the are provide data intended regarding to therapeutic when tazemetostat studies coming of in with hematological insight other development of in the these in solid a its potential steady broaden and an effort combined both important

excited oral novel is first-in-class I'm share making inhibitor progress our tazemetostat, to Beyond EZMXXXX. we that SETDX are

sites for opened currently for first-in-human have study. Xb We and screening Phase enrollment are patients

We the intended of of and end and to myeloma safety expect the EZMXXXX optimize the The in first dose multiple is the to and DLBCL dose patient before evaluate study XXXX. schedule patients.

t(X;XX) and potential research of to risk including expanded which high the not monotherapy non-t(X;XX) have the multiple myeloma as myeloma and three of potential pathway, epigenetic in been with multiple innovative to patient multiple dose, to t(X;XX) has to study emerging been Epizyme’s in multiple demonstrates DLBCL optimized from Once and cohorts; SETDX X the tazemetostat. platform. DLBCL. date, productivity approach and drugged settings, successfully in and Our including existing quality we utility inhibition and will be our myeloma, clinical shown have intervention the combination Phase has approach therapies this

partnership HUTCHMED our with advancing. Finally, is

HUTCHMED get with proposal China, collaboratively tazemetostat is We new to and combination are data. meaningful can working produce SYMPHONY-X a in on activated for that site working additional trials already

just call for These clinical clinical as clinical existing see, in look trials foundational At December on I’d steady time, sharing and years, execute ES, the trials to cadence As like but a pipeline ASH forward develop a its FL coming data Grant. are not both we potential. look and intended to drug to and to yield therapy can TAZVERIK across you to and to expand we a regular to the pass of as in we this continue results from planned back updates. our

Grant Bogle

part quarter third Shefali. TAZVERIK which in in on We cash received you, as cash, $XX ended call. includes the payment Thank upfront of equivalents million securities. the our collaboration million announced and marketable QX the earnings we with from HUTCHMED $XXX.X China, This from

operating months. and it is XXXX the quarter our million were We of operating into non-GAAP Based earnings announced we sufficient remain non-GAAP revised of quarter accounted SG&A our and plan announced second approximately $XX.X for full the for total have the our with changes structure XXXX. earnings impact on And the to expense quarter our call, during year sustain cash $XX.X Our believe XXXX. for million, more significant to expenses operations operations third will of $XXX the the second guidance operating and for million, R&D $XXX budget current a at for least respectively. $XX.X million on on previously expect on the between adjusted million to which expect next We fund XX a call target to fourth changes quarter we XXXX.

we and recall, costs XX% were current the million. employees, our termination charges resulting XX%, severance our after first to Epizyme's and my these CEO, I'm beginning to change, we’re with with changes. the on team the receptivity as pleased has tenacity the reflecting company's see action already to been which approximately XXXX. of in in will quarter of Overall, including reduced These by $X the estimated you take willing As of third recorded from budgeted results quarter headcount

changes bear we While fruit into to have as expect to early, implemented the move we we XXXX. continue

building team pipeline expand we the portfolio; we line collaborating number open believe of one, finally, may three, pipeline to value. two, The expanding patients made against on serve, our and strategy our announced you four patients four, reach have drug TAZVERIK; the incredibly to and maximizing to each. We by potential; and incremental and of to call and are questions. Epizyme is the track. Operator, important adoption progress the during the TAZVERIK the right dedicated on continue vision in now and our building guided Number number be for pillars we commercial our March, and

Operator

[Operator Instructions].

comes of Peter Our Lawson Barclays. line from first question from the

is now open. Your line

Peter Lawson

about the Hi. made SETDX multiple just landscape you I Thanks you've that maybe think the could question. that fit activity? guess in if where and with you or and for see myeloma you. you of kind use actually there, taking do just for think there's into DLBCL, single combination Thank progress combination good and use, think how the on would candidates the do you agent

Grant Bogle

you, Thank for good Peter, and Thanks morning. joining us.

probably I best think that's Shefali. by answered

So Shefali?

Shefali Agarwal

you, Thank for Peter, question. the Yes.

of what's And an in one myeloma, unmet big is the plays is actually that SETDX in patient And know, need. t(X;XX) methyltransferase. it's a is There strengths that poor which that population. clinic. the you is as the prognosis There's role it exciting of SETDX So a first-of-its-kind important inhibitor. is this multiple none histone in

realize a we multiple although see, where that population is So based really great on subset we there preclinical is of patient a data, myeloma competitive, is there effect.

non-SETDX see in However, as do effect we well. patients

is is study will find have expansion So way And the dose, first three study we the the the dose. we into once the open we cohorts. will designed

t(X;XX) The third is myeloma one in and DLBCL. one in first expansion cohort is multiple myeloma, non-t(X;XX) in the the multiple second

Our first eventually approach would data then be combinations. to test and definitely monotherapy get

we our myeloma multiple to plan DLBCL validate multiple models, We and have done combinations in in that. and preclinical

Peter Lawson

Thank XX want ASH, in to we what you patients look Phase just you. Xb? from ahead to you. And do Got the as from that see then the data

Shefali Agarwal

Sure.

a for think -- I SYMPHONY-X study, rather study, Phase So big patients. It's XX of right. it's X the in terms about

have consistent shown. looking are that we we at response So a rate

XXX% remember response earnings. If last rate showed almost that you we the in

a plan to So response rate. consistent show we

up. more for we We a the as dose, are at clinical little can highest looking as combine that follow pharmacology safety, more well

smaller Phase start to ready on really I globally, that it's think because we're important hard unlike big to run-in get China, including portion a safety studies. year. our other X randomized important And it's planning this our working is it So set, data

Peter Lawson

when you. update Thank And prostate? Shefali, we Okay. the may I then this, missed have next do but for see

Shefali Agarwal

label after up open PFS an median we at it reach really follow run-in and was study. encouraging didn't you because presented even data safety The enza. was that it's with of So months saw and XX Peter, combined ESMO,

data And looking we'll portion But the so year. the at that we the will is other provide be run-in safety study. of for randomized more updated thing next

enrolling that label actively completed and an nearly are study. open half study. We It's

we enrolls to plan we provide year more do the data that. So study to as when next present we’ll be interim and to able as guidance will

Peter Lawson

Got year various get of readouts measured more data Do next 'XX timelines you beginning you. around we'd think from trials?

Shefali Agarwal

think so. I

as to able think we'll next I early year enroll, doing be we probably, because studies. we year, lot a more provide next of update are

both We are and label, the open is basket tumors. solid doing for study, which heme

the have SETDX front-line said, We is as we nearly for that label. high-risk DLBCL, LYSA which and as trial, well updated In I XXX, the FL the also data complete. open have

the So a stream years. providing couple we next looking are in of of to forward data constant

Peter Lawson

Great. much. Thank you so

Operator

you. Thank

Our from next question Michael Yee Jefferies. of comes from the line

now Your line is open.

Kelechi Chikere

Hello. Thank you.

Chikere have You Kelechi Yee. on from Michael

question one are if that do really And it your order guess their driving TAZ. to sense actually you what's Thank any how front? there you. many system color from interactions have optimization that a provide helpful. workflow on number color really with case, sales Any on workflow be needed drive I optimize a would Does us of team? I'm the could certain occur Just organizations in particular has healthcare after more with wondering you here. interactions if to that of is

Grant Bogle

organization account. has different, at start. me important that one, sales the to let each the TAZVERIK you. advocates is a develop but within from been question. a our great start level. doing That's team And Number foundational for Thank it's And

way, but TAZVERIK and the want the of there engaging looking leadership them if the critical. The get always physician to organizations, conclusion, that individually, it then we're in the the to that and done. within but opportunities the actually and advocate do advocates with all and these this comes really decision. in just becomes both it looks, a vary or in the physician that is it's that with But So then understand to forth, leadership on step that made And organizations things this getting workflow, then improve work much that optimize next different them priority, not at basically to operational essence, by physicians there physician in organization supporting get conclusion these then so leadership, use that not the and physician someone going with course just steps helping are and to an is of it. them be and once optimize advocates that appropriate to they've unless understand given healthcare helping doesn't may organization,

that's takes the really within it process. doesn't the organization. so points several calls different And it takes -- It and touch

help something receptive. months But patients in realize say they're organizations is So refractory been a very I to appropriate relapsed they important probably treatment of their when access it It's available this way have they it's decision. you what them option. must or not a information physicians of have call. that the a a to to to consider them done. And that want to matter get patient do the to in make all a that very ensure the single help they've front

Kelechi Chikere

you Got it. very Thank much.

Operator

Thank [Operator Instructions]. you.

from Our the of Bohnsack Peyton from line comes next Cowen. question

open. line now is Your

Peyton Bohnsack

And I on on the mostly with going guess basket call basket other the Peyton HUTCHMED our do studies, to Hi, studies for you for really additional this guys. collaborations Would portfolio? be on HUTCHMED. HUTCHMED, possibly questions. is on studies Good going quick that with morning. just with thanks the the are collaboration oncology TAZVERIK Joe. taking This mentioned for separate you're drug to some include these or and

Shefali Agarwal

talked basket IND we that study both have solid have tumors actually heme clearance to begin for about in the and is U.S. So with.

it first moment, quickly patient how are as and U.S. possible. only At the start to we ready see we'll in and the it's study and HUTCHMED with proceeds. collaborating are we course, Of as the get

more You'll a to are indications combinations multiple proof-of-concept those data. remember with studies, we and basket get in able Bayesian method doing be to

to you than have in further well. as are more doing can basket terms what innovative going In we they big of basically do a form see. They a pipeline are combinations as HUTCHMED,

able in do are what like that also excited we'll get data in others combinations, we the So different but are not that we be their are multiple and what doing, with to only VEGF HUTCHMED pipeline. will

Peyton Bohnsack

you. the methylation? are looking at being doing Awesome. for develop Thank any are on diagnostic secondly, a analysis analyses you differences if conducted? SETDX are any kind exploratory anything And Great. HXKXX there And any out guys biomarker in like plans of study, exploratory of comes then test biomarkers to these that companion

Shefali Agarwal

Yes.

So that's absolutely.

are we medicine. very company, a to committed translation As

We of looking actually are at overexpression all of and those, study including HXKXX, mutation.

looking are then do The at we we be is things expansion, first study. our So dose goal the biomarkers. when in at all those to find eventually looking PK and the we'll

of and that We as collect XC there [ph] have also well, so understand. option data

In companion I have we'll think it diagnostic, see how to goes. terms of

in to study how in not. population. we studying all we'll we'll diagnostic both think and see able this about Our non-t(X;XX). depending goal on be the or to now, patient be the we is activity, Right need t(X;XX) And whether a

Peyton Bohnsack

back queue. hop the Thank I’ll in you.

Operator

closing I no am Thank the time, I you. call Bogle Instructions]. [Operator At questions. turn back for further to Grant over showing this to remarks. like would

Grant Bogle

And patients facing say steady Thank you, report progress improve for steps and to ahead. all many in lives months at Epizyme, look to to of interactions myeloma just and joining continuing us in excited this also the behalf we're I areas are forward want devastating that Thank us you and lymphoma the of the all you, I we're further of that operator. of making look want and about forward here we're operator. on the to thank other morning, to exploring. follicular disease to I

Operator

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

You may disconnect. now

Epizyme (EPZM) 9 Nov 212021 Q3 Earnings call transcript