EPZM - Earnings call transcript Q1 2021

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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 Bill Slattery, Jr.

begin. may You

Bill Slattery

to This website a operator. XXXX issued press Section as a Results. found can Thank the epizyme.com. in update morning, in providing Investor slide well as business press the Quarter today's addition release call That be company's you, of release Epizyme accompany at to Financial First

Commercial Executive Financial Bazemore, Executive Officer; Chief President, the with Officer; Vicki Strategy Officer; On and and and call Ros, Development President me Agarwal, and President today Chief Officer. Vakiener, Chief and Dr. Officer. Chief Tombesi, Medical and Vice Executive is Chief Matt and Rob Business Paolo Vice Shefali

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

Rob Bazemore

how QX and to with year. you here results be see to progressing and great update Bill, It's you, an on everyone. Thank our morning, good our provide this we business

travel to normal, even than Vaccinations broadly eased offices and to starting to we signs report it. much for things travel some that restrictions are encouraging are to available, we for earlier from moved that in-person the to we field-based the they're began second March perhaps beginning to end slowly and institutions now reach the we before. in March, discussions allowing customers patients busier into see employees bit the them and that again expected. more their see vaccinated quarter, As the than of offices At a they're are more very return allow

representatives reopened the to have exception norm. although accounts this Some still on calling than more is the them

educational some conferences. regional to medical programming return And is to like in-person beginning

slowly pockets country All different to happening at is of but is begin these and the it's in rates at changes. happening of least very to see this encouraging

of resulted However, the that and as we areas. some QX was in extension a still late restrictions XXXX for wave yet dealing started were this not of in infection of or case the second that with year in heightening

Epizyme growth pandemic number TAZVERIK positive build as coverage renewed been challenges experienced continued like virtually metrics due Despite to almost year. the the the important that momentum a will and beginning year to significant on we control have execute of persisted. in of we QX as that to and As had ultimately was we prescribing continue broad at awareness these continued we entirely result, previously adoption the for and accounts last the be challenges over to unrestricted access the

Episode March $X.X continue remainder a and Epizyme million. March, the follicular at Commercial XXXX, $X.X TAZVERIK five Next our who I four which which combining quarter-over-quarter with shareholders quickly in the the XXXX, the yet bottle early effectiveness revenue to bottles revenue long-term in agents ES we'll our The important or sales or ensure strategy the contribute booked and treat entitled possible, in haven't bring net and already. value encourage event see TAZVERIK for next terms across physicians $X.X increase month-over-month many patients where TAZVERIK representing growth in approximately Epizyme execution call was create eligible quarter lines FL. In over the as as first TAZVERIK therapy FL adoption for our adoption for pillars. and XX% and first revenues this to patients lymphoma of growth of to years. U.S. million them revenues recap by earlier ES to adoption including upon Epithelioid to by most maximizing a QX demand is Total driven in QX successful into continue of to We efforts most But vision in Obviously, the strategy and of how the QX. monotherapy. TAZVERIK over we you development with if our hosted the XX% near-term you were level other same and total as increased of other for were unveiled quarter-over-quarter the strategic revenue increased month listen was sold. million, primarily by sarcoma webcast commercial as the to focus to among or collaboration of relies

into Second, build and additional solid five of steady continuing tumor moving over programs TAZVERIK's a drug produce and hematological and and data the to next including on malignancies years our stream potential pipeline beyond. the

novel Third, expand development. and into available patient expanding across portfolio our and leveraging TAZVERIK, And therapeutics reach beyond made we good progress increase these value the shareholder four fourth, quarter, responsibly. our resourcefully all epigenetic pipeline and first bringing both clinical pillars. In to options

build in adoption to momentum subside. begin ensure the headwinds despite earlier we persisting metrics once continue accelerated the on challenges pandemic needed to mentioned I to As QX, COVID

explore data and we multiple further on cancers trials, for On XXXX we're beginning across encouraging and steady and of hematological FL in data two a basket as initiate and the combinations we during to comprehensive a of this the innovative half the prostate which which clinical our over new in anticipate side plans highlighted during TAZVERIK, and clinical solid year. to years next for in both some stream With monotherapy tumor second-line plan and track second early tazemetostat cancer development from the vision five studies. outlined we call,

and submission XXXX. who planned ES. now I'd on pathway Followed long Finally, was turn to after who will Vicki? over the like inhibitor, which Vicki to introduced FL the on our additional the for quarter our Paolo remains SETDX then sought call during call for our in mid review will IND first novel provide call vision color a open and track on Q&A. progress financials by efforts. Shefali update briefly to QX TAZVERIK And we before who development tazemetostat will an and adoption provide our addresses

Vicki Vakiener

increasing Thanks environment month-over-month saw the TAZVERIK is while our Rob, good growth, we COVID. everyone. sequential to navigate with and Adoption highest March presented traction, morning, to we and continues unique steadily date. gain representing by demand

TAZVERIK-aided compared intent-to-prescribe share market the market in bottle We in and new fourth research patients the coverage a which awareness we transition start first therapies all TAZVERIK among there the the Now now and of utilizing on both prescribing QX in continued suggests the to and the for and the in some increasing see expected, over first community fourth remains XXXX. XX%, our FL physician first Aided policies in awareness quarter among to patients program FL-treating of that physicians was to payer the Epizyme changes as quarter other continued to add quarter We any improved commercial academic setting, at our or unaided accounts XX% our year, aligned from lead and to space. in physicians years is been with million. in assistance patient the revenue of other XX% is voice quarter was didn't to related high. have quarter. XX% Commercial agents to XXXX, compared demand grew total $X.X that by while and

epithelioid is some second-line. channel, XX% sales coming setting TAZVERIK queues we a wild-type largest third-line now of in untested. result come Within and our the treatment specialty and has sarcoma. therapy to in split of later growth have refractory by utilization relapse we from share through lymphoma efforts and to are our and follicular in As continued been lines distributor the of visibility limited FL, all mutant the Since utilization in see both

However, on both. are we we that research based market utilization seeing know in

mentioned, same as contributed TAZVERIK with patients at sales QX in for As EF the level QX. Rob

some continued patients start therapy quarter, of see treatment. in lines new later patients the the therapy cycled in We early treated so to first off of

adoption benefit provide order Our focus rare on with extremely this of for in year lines gaining most living to broader patients in TAZVERIK this the for disease. is earlier

to end and staff. their of FL following the field therapy quarter other compared the we that to call environment physicians fourth in treatment this the of late population. change general levels challenges As to with onset the two the patient the decreased treating year. face-to-face And substantially quarter. starts in the include, shown frequency access treating and to doctors that of due approximately the the and operated FL to their has indolent been age quarter, pre-COVID we February, The from in patient not first last the of COVID-XX, to has distinct year any our to consistent XX% on compared nature disease fourth during on limited patient teams second accentuated visits persisted alluded first, QX cancers data depressed which new remained early have did that XX% In

visits will new to number a sources While do of starts have The epidemiology now to that many been and has of the We COVID. anticipate of patients we slowly any see FL expect secondary vaccinations treatment rebound. fundamentally changed has as suppressed patients receiving will beginning data treatment to new for continue to result as increase, yet return in-person confirm months. that

Compounding restrictions to and more again wherever following have encouraging, require approved accounts the with to beginning appropriate and eased to distinct in team engagements two for are this relapsed with opportunity very improving our than to signs indication for consent use statements. of share TAZVERIK time explanation to because prescribers traction the case given refractory live see in-person. virtually, travel are possible. This vaccinations particularly can We FL, is might it our broad the otherwise and customer has happy taken are positive physicians field be that patients allows we while allowed and that get visit label it in-person

of expect our treatment access EZHX wild-type the lines will particularly customers patients. improving to in to in our We earlier direct ability define properly benefit that use TAZVERIK

see it of increase treatment, of therapy to in II their also QX. later-line patients some occur, within off appears this trial. same new continue some Phase new accounts patients reasons discontinue We the why patients and same to may in are a variety few starts in TAZVERIK of an seen but quickly months where the by first saw we clinical There time, therapy. prescribing treatment. have our We driven dropped be this phenomenon for At

tools launch of many drugs. other might any In disease new the oncology, treatments you most burden with to physicians of with often order been our with new need patients stage we new for utilize very are patients rolled patients through in sales ensure high marketing expect, team late in assist in appropriate earlier most to TAZVERIK. that TAZVERIK they've As need out the treatments, recently and identifying in

to continue with the drug awareness team's with we TAZVERIK, satisfaction of adoption journey, physicians for result. in in gain we're with physicians earlier under enhancing improve treatment particularly current circumstances. encouraged TAZVERIK the using the treatment As and experience driving Overall, a the expect reaching as and with duration field performance TAZVERIK will

is not physicians XX% treatment they're continue diagnosis testing tested. that test increasingly often It's mutational of initiation their plan. about as indicates see at that research of still we patients' treatment. XX% for with of important feedback their before gain for to As status note everyone, that first-line EZHX patients of test being or likely to EZHX, approximately now patient's done being but part also more from FL to customers, EZHX we physicians our are only testing Market in

reasons, to commercially of to panels in prescribed understanding patient's are access physicians set other understanding While an better available they like sequencing their that test via and one-quarter cancer TAZVERIK. would multiple physicians mutational have next-generation helping would like so. to to EZHX way status expectations do around with institution of Physicians the easier most a and noted for once have interested patients including or

testing the community physician regards inquiries to around solutions easier. their to provide make We and will support testing new with to continue

our ways ability and to TAZVERIK. the expand to Looking are confident forward execute of we find continue to in commercially adoption

Shefali? We customers are returning will we and that optimistic who and an questions broader call this also look like patient-physician more have begin our more forward to clinical interactions normal. to update Q&A. to opportunities will with will the At to time, face-to-face to trials on with rollout, and I vaccine addressing provide ongoing I'd Shefali our development plan. your during pass engage

Shefali Agarwal

Thanks good Vicki everyone. and morning

that patients combination be combination share relapsed/refractory TAZVERIK patient During in a in for activity the safety data with Vision second-line early Xb/X follicular the EZH-XXX of consummated study, Call, we this and from preliminary later. could provides and treating and approach RX meaningful that a Phase signals

in individual all patients complete the response. of adverse Call responded patients Vision DLT patients four and seven the enrolled of the available having a consistent three treatment partial with XX this to We to update on were the at and a follow-up. Annual observed the patient of Meeting the As agents. having additional events profile we with safety No, treated the to on study, data plan expect the were response provide where year safety stronger to later ASH and dataset an a have

event to second study, potential We novel Phase the study enrollment the an readouts the the study, analysis completion the to as This PFS the a Once conduct of we the second will aligned portion is completion analysis. and X the opportunity after selected protocol As the the plan on as provide recommended earlier FDA protocol X will the safety early effect we for submitted availability an personal the stopping dose with agency of of interim the data change long for at of have predefined opportunity allow procedure any than specified of efficacy achieved. treatment in these in an Phase at an all PFS for interim the to efficacy we have review. to the important [Indiscernible], the events. protocol

to the during we of dose with RX. RPXD study. TAZVERIK by support well of This XXX external the as of efforts was the endorsed X was EZH-XXX requested safety selection review, initiation dose effect that the Although randomized portion additional milligram and characterized an steering the to optimization agency Phase ensure committee committee the the an of combining have

enroll XX this findings per cohorts for have the operational the PK, of and submit activity with of number the to enrollment safety XXX impact including all the which data months started, in Due at of optimized promptly collected a the completed In we patients meantime, discussions levels the complete patients patient these patient had completion. minimum signals important study. Phase study two number note global Based a time XXX analyzed patients agency, by that required Xb we to we doses have include of allow study, particular not we after Xb to no the of design. exposures, follow-up, dose and that data safety been for our the start-up the milligram on at that observed continue required request will pre-specified cohort, requested concerns enroll of only dose at in continued is Given of or milligram the BID continued the dose fact our additional additional cohorts these and have safety to since to-date, the Phase agency. small for these total the observed safety two those to on the for run-in effort the and three a Once It's minimize based study at for of it the EZH-XXX BID efficacy. any both to collection to level we initiation nearly the to will the efforts enrollment for agency. DLTs

move few a preliminary study study related We weeks. as at part in ASCO in the report a the continue forward ASH look from as to the Rituxan EZH-XXXX and planned. this activity data plus the activity We in ES relapsed/refractory Separately, EZH-XXX TAZVERIK later year. expect evaluating data frontline TAZVERIK DLBCL to as updated post-presentation in evaluating and FL safety and sponsored to safety sharing studies trial of Confirmatory such safety EZH-XXX and in environment FL high-risk to forward

in combinations initiated studies half and hematological be two Additionally, of solid second remain track tumors as our evaluating proposed multiple such on both to year. this

year. end to work registration the Europe FL continue by expect TAZVERIK ES to alignment to also of We path and the in have this define EMA in with and for

or During allowed update castration data had tazemetostat called resistant or with course patients the XX%. Phase than of study cancer In Xb/X patients enzalutamide, of therapies, prednisone population Tazemetostat where plus safety those which study, enzalutamide PSA out prostate protocol the with early six is abiraterone, of chemotherapy. Vision the patients encouraged short receptor tazemetostat. this generated. in run-in in new patients to on either enroll study, Call, greater enzalutamide of plus combination response is provided in abiraterone the we need of or generation have substantial, the for an In patients data where we preliminary besides in EZH-XXXX. we first XX In anti-androgen the metastatic prostate a plus the Particularly who the we cancer from chemotherapy are also options portion received having decrease previously by PSA the saw MCRPC

investigated one with particular radiographic who reduction patient receiving enzalutamide highlighted target response tazemetostat also response that We diameter. after PSA in had in a and vision also XX% had

were enzalutamide we dose year. combine patients additional The comparing is Phase and follow-up X X patients study a milligrams of medical versus and the safety treated later actively to this tazemetostat on the conference Phase able at the expect drugs enrolling Xb share Importantly, we X,XXX updated and of plus any concerns data without alone both this Phase longer to enzalutamide BID. portion

track intend to end. by during our we Lastly, and introduced move the Vision planned mid-XXXX on Novel for year IND clinic which into submission SETDX Call a remains are

data and a pass cohorts of myeloma. review concept The will call refractory relapse a planning in near escalation in XX-XX Congress multiple to June. three relapse/refractory first-in-human at term, sharing the tolerated of At are European it too maximum multiple myeloma myeloma, in we valve relapse look and expand I'd like Paolo who quarter TX-XX to and dose this on the proof including our Paolo? preclinical In trial dose the first We Association time, to study results. financial DLBCL to the DLBCL. last refractory refractory Hematology to forward it

Paolo Tombesi

you, Shefali, good quarter the securities. with $XXX.X cash in and first Thank morning in million We equivalent everyone. marketable cash, ended

which million quarter million operating for the $XX.X first non-GAAP $XX.X accounted approximately total of R&D expenses respectively. for XXXX Our and million were SG&A of $XX.X and

quarter million which we million sales $X.X TAZVERIK revenue includes revenue. other $X.X and net of FL revenue, and in $X.X to ES million recorded Turning in collaboration first of XXXX

year continued $XXX million full of capability launches million our patients range reiterating additional expenses ensure in are commercial clinical investment our in commercial clinical the trial. of and support We including adjusted guidance investments supply development in non-GAAP the which operating to for will in $XXX uninterrupted to XXXX our TAZVERIK manufacturing for

As a stages that early given COVID-XX our pandemic. the not is revenue reminder, we and to the launch are uncertainty related providing continuing guidance evolving

Finally, we operating and XXXX. remain support into well with to financed equivalents cash plans cash today our current

deployed few maintain important to the strategies initiatives. Over we past years, sufficient to have capital multiple fund value-creating

with We on stage expense will prudent a a the and investment approach our continue our evolution new studies and revenue. gated make of management based

us We the our to back over plants options closing also return have to to like operating number a call of into with enhance available future. well the comments. Rob? support I'd now our that, to cash And to runway Rob for

Rob Bazemore

Paolo, Thank Vicki. you, Shefali and

launches improve that As the are encouraged we quarter, to the that we quarter in the of our start will dynamics positive optimistic our momentum. from have I'm some beyond. second first and complicated emerged by

data Phase quarterly SETDX with progress run-ins and initiate Looking IND of We We'll cancer medical for safety TAZVERIK remainder with FL at the our milestones expect present our longer EZH-XXX on and for the provide a in company the to We'll meetings. submit EZH-XXXX updates X in follow-up eventually study. forward, of plan and year. US upcoming we prostate the in on number updated important adoption.

open He ENA finally, long-term the of a the Malignancies TAZVERIK we will expect Solid with living of all, questions. to reach optimistic lives Europe. basket registration and to We in two And we with of the Above line Tumors. for line in Operator, for cancer. path TAZVERIK remain initiate trials we'll potential change now the patients in

Operator

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

open. is line Your

Michael Yee

for and morning the helpful. That thanks Hi, update. very Rob. was Good

Rob Bazemore

Thank you.

Michael Yee

We questions. two had

as XXX, patient the or talk better. was to of commentary and Can XXXX? then And have accelerated increasing in confidence question shelves just was a guess, events. you XXX? And actually second have environment that about First two perhaps thought general office study you on just I Do and to trend make do XXX comment to being much incremental efficacy will the that's think just you new the think on think I that getting accelerating it's on maybe sales? R-squared how Shefali. I there is maybe physician visit chance a better the the a efficacy? lead comment use in or the were that talk growth the about March you think Maybe futility of you quarter-over-quarter? XX% or a there first about sort you. because very versus and you'd analysis One trajectory at for Thank to things. interesting Is then interesting is sales

Rob Bazemore

Certainly.

we let question answer see COVID talked that around how Mike, your to unfolding start, So just dynamics regards with about. the first we me year the I'll

I that were As continue quarter to number prescribing the the call, on to accounts see encouraged we TAZVERIK. said grow first we

We continue to XX% of saw grow of which compared the a to commercial up number bottles. quarter-onquarter actually adoption the was QX. We use

had conversations on most virtually you data, and two the and have to do the virtually. our have just ability ability have about launched remember to about have them conversations that things our to physicians go to impact inefficient things that it made the access have If we the difference said entirely that significant more just label. face-to-face the we've back and this beginning, always when been most drug from the you have That's two the it the get launch

more around label the happening in the so. doing a them of and things is with data. substantial And this when and majority that back vaccinated for more are they're now, the to us interactions allowing travel reps access two field reps encouraged back substantial to going physicians putting field in out a and our we're So the the that allow with comfortable

this just been down always that The patients their have seen patients starts seeing second has new been have as beginning. been down aren't there that we've the visits fact well physicians, since as the down, the has been

First quarter than different quarter. no was fourth

So bring starting just starting that patients office. their back the We're we're then drug for that starting We're patients a back to new was see see launched, come to encouraged to change. to that's see in adoption, you they they're remote. if and aren't if making can't we patient's if the patients seeing office, change get physicians just And there the aren't decisions. in them know typically not the they're don't as switch physicians therapy, obviously

encouraged being year. about have those adoption both indicators we're over it's said, grow of of So of course to things That substantial continue the been most the seeing not leading two same the nationally. Those barriers. the being the

closing saw we like regionally. happening it's think I with things down,

see others. are of You more than areas where opening some quickly pockets

able where go And offices who've already. remained the then better closed have areas access are into to there we're a back others bit Some customer's for longer.

we'd on vaccines start that So not sooner to starting see anticipated. that see happen and started by to the up sooner. And encouraged really had that we uniform We availability But open based country. already happen to fortunately even across of than to the mid-year, we're we're start again, of it's some change. thought this

XXX turn over to Shefali to it changes patients And question and those are to quickly with around are we your physicians. how answer going our of those So that, really to both getting of because things by TAZVERIK the access try to and why Mike. see two help that encourage I'll the happen out are respect directly influenced those in their adoption that's most

Shefali Agarwal

Shefali here. Good morning, Mike. This is

I first So answering about the interim. just your question think

III As we recall, the study the for interims. two has Phase randomized

The fertility. first interim objective that for based strictly is on is responses

of on is have gives you're on and early PFS do an events. signal a It to actually giving you events. how don't stop it's So with This which efficacy. FDA not just aligned XX% is right that give one recently second it's to And the opportunity your study going. interim you The does a the the study you PFS for all about of we PFS events. that's trend but absolutely based is

the So too as events you could as have the availability met the of you've long predefined data study.

alignment important FDA In So that second your it's an about question with to the study. regards dose. for XXX had the we

aligned on we the safety time the at you had approval for actually the as with FDA of study So run-in. recall the design

did without complete the quickly any very However, DLTs. run-in we safety

characteristics in was So no observed was all concerns other order of milligrams combined this not is R-squared There with profile enroll in minimum basically to the both with the more terms This well is of of agency XXX to consistent This XXX a combination at milligrams. TAZVERIK safety to and additional XX us data characterize sponsors terms safety issue. with the package get basically other products saw very have with asks other PK patients study or the including that insert. PD. we safety the we in The R-square. and is that similar been additional in

and mentioned completed the be that as forward. in have script, is are So we to to able these XX for patients. patient, my enrollment looking these I we enroll the basically nearly goal And

that any We Phase study for Phase are do III. quickly. the enroll impact activity minimize the to able startup And hope to doing everything we can III to on to be the

Michael Yee

Thank you, guys.

Operator

you. Thank

Our Bansal Mohit Citigroup. comes with from next question

open. line Your is

Mohit Bansal

Very A Great. One from side. questions on Thanks my morning. my question. for side good taking of for clinical couple Shefali.

with asking is terms that mutation? better did in FDA dose as see given for anything for Amgen EZHX Has this not So that milligram XXX do it to of Is exploring BID saw We FDA's well. additional looking to related you milligram something optimization? it new that with BID. something a

Shefali Agarwal

morning. Good Mohit. Hi,

It's able with R-square highest milligrams as any combine I DLT. as other of I when said And is the R-square at you is mentioned we backbone. doing. DLTs. it think consistent ensure safety were without The a rightly. very people there – on with TAZ mainly think it's any with is It's there I impact are no go what mainly that to And goal didn't is We optimization. XXX not thing. we dose see the dose to

those think optimizations XXX to which at look a to be minimum XX two safety with are XXX not and signal. I doses So idea of do is the and able patients a

Mohit Bansal

question things Very it. little helpful. the in a to is that so better. prior bit you mentioned other to Got up kind – related response the question opening of And are

you expectations So is it understand you. And it question coming EZHX on the turning can of better the things patients, usage usage in second just can year any Is back the metrics in Thank out? mutant are much are how trying how the EZHX or the comment going test? to your then is usage specific provide only terms of if and is into mutations of part of offices EZHX patients? than this to how you in physicians biotype restricting

Rob Bazemore

I'll Vicki is This add if ask to Mohit Sure. on I Robin. anything that missed. I'll there's start.

First with view specifically on progress is year on the this starting. how timing to of of regards comment my our all, will early things how was this

I year mass think and of conservative, that normal therefore and assume start then return really of the a things half of year. starting see and we'd to to around to the be to middle progressing second the we'd just amount of immunizations improving slowly

open you're thing doing removed things see seen you've of are that a encouraging lifting bad a around many restrictions their a states COVID. that or thing it's that's have seeing are restrictions. their starting to back as up that good to lot So states Whether now

to give I terms want in how of this think pockets. progresses, it on because happening wouldn't I in it's guidance

So that opened have like accounts have that already. some you

say are very to physicians coming that about busy not. again. their have patients of offices many When in, back Some that we talk them

back canceled had at risk. said, want because to didn't Some want it's not risk. they because them But put didn't have of to come have at others who they actually the patients in they them say that be patients

the of being things pulled kinds are that we chain like think J&J vaccine period of supply Obviously, of here. a with I So at vaccine. of a things things there's Those can never time affected play the anticipate. for lot that

tried be So I've not fact thought. we how doing things to real thinking seems the desire too to to to said. we're on back than be normally we the There seems it that more year starting a other than be sooner about go specific to

they medical desire be in conferences to pre-recorded remarks to we're coming back her to hear see I think to out. drugs want starting new industry. They because from want in that know script They the said Vicki go about the face-to-face are educated. that, to regional

face-to-face conferences And medical starting some to live of to the go as opposed back to regional so being also meetings are virtual.

they're as most we useful are us to those to the adoption think encourage going things that increased the are to be return TAZVERIK things that So to normal. and things the those

is the I this testing of think to add it, I use done not And I'll the think as part not. a can our decision and research even for isn't asked TAZVERIK. with use to testing whether regards that a but TAZVERIK testing, one as things observed the we've you barrier the of is of Vicki or in start to

tested the about fact are at are front-line before even half diagnosis who In tested patients in the treated. they're of

that reasons. So prognostic some for is of

physicians wanting again it type Some their of the is to lymphoma just understand of have. patients follicular

accounts that half other the And of testing. who refractory is relapsed in So half testing the for almost then disease. have coming patients of the

to patients And it TAZVERIK. they're They're think I I'll of because for looking a trying further the use number who not whether just set expectations But reasons done use of across therapy. and of to being the TAZVERIK. want ask not lines determine Vicki perhaps the on if to it's to you test on are actually use is different that. characterize comment of different says for or to patient type treatment better research Our

Vicki Vakiener

Yeah.

other would understand an opportunity follicular the think add disease. I I time is this that increase the these in to have had while first seeing mutation lymphoma only testing we're really this really and physicians is particular point the

next-gen are make that sequencing And choose only treatment access and say, the I is -- panels results. for what, status know I may available full need for I we panel one necessarily for the about I not going to information most mutation run group want done lot there a to TAZVERIK. use groups the them while just we’re setting if know One that to the other make are physicians physicians the I'm you treat do of sure when don't have so the to certainly that a lot say, so. XX% We've to with want consistently mentioned want of helpful focus patient. that if I decision, interest. a thing EZHX just a expectations a testing it to what there's they to is And physicians but

them. just that handful the innovative is solution we're meet every possible not a the to looking not bring want institutions to we So test, them an at significant to any testing is to reason some which sure solution we're prescribe TAZVERIK of that Covax their bringing have sure to available, PCR for needs Granted, make and opportunities while physicians. there's these make and that

Mohit Bansal

Got it. Super helpful.

Vicki Vakiener

future. But announcing the something near soon we'll be in and

Mohit Bansal

Thanks really it. Got helpful. lot. Really, a

Rob Bazemore

Thanks Mohit.

Operator

Thank you.

comes Lawson from with Peter question Barclays. next Our

Your open. is line

Peter Lawson

and Thanks good the update, for morning.

script be Just that for revenues? color getting for would that, seen April, You've Any around similar great. is trend kind better? of, that

Rob Bazemore

commentary our think are early to on and market I that comment of too to for being that not Peter, of so think indicators revenues, and happening of we've it's the our itself. to to achieving that positive the we probably patients have product middle right access to XX% in in is the trending see it's their since on in new pandemic prescriptions again start to because customer consistently we've on always on And to year. on to physicians. been that that things last continue TAZVERIK. TAZVERIK actually that both but line important much scripts that are back very just we ability seen I launched ability but Well, adoption to therapy ability the our see thought down of in that very And pretty Those XX% is the leading see drive any of new and adoption trend get particular to depending the

us that for in optimism to ability need office their they've going but many, those in are ability the also many So the for but from some access that Not been change to their many give these away prescriptions for patients there patients in to this time. keep to who've the of patients to is customer, been bode-well start all patients offices things our are mind change. And who away see and months now. their

think of they've It'll so many as able off in change. physicians and be they because going dropped either imperative that progressed. back them quickly patients treatment for they're to those of them likely to they can to treatment because important get And of in be I that as back make it's are get

Peter Lawson

tazemetostat Thank expansion you. could And Got you. guess then the out for basket I for, what read first? indications the study

Shefali Agarwal

Yeah.

So hi Shefali. This Peter. is

So run-in all at is safety design. together. you're looking It's the indications innovative at looking the the and basket basically a study then very

different all patients looking and different with there actually are basically it’s cohorts for basket open-label, goal The to multiple all heme indications. cohorts you that indications on follicular itself. enroll And at it's So, And will and starting -- study, cohort at are is together. the the we lymphoma, myeloma able each cell. look because the be look the cohort mantle in at can DLBCL,

see, have fairing how that certain first, the it right and don't what XXXX. out we'll would You looking by what's and of in population, really of to are is to starting from be And one because then a data using simultaneously. understanding be patients enrolling is, read efficacy, the which is they method we brazen regularly biomarker able terms at number

solid the basket that's goals and heme for studies. both So

Peter Lawson

Good. you so Thank Thank you. much.

Rob Bazemore

Peter. Thanks

Operator

you. Thank

with question comes next Cowen Thome from & Company. Our Joe

open. is line Your

Joe Thome

for you Thank and taking questions, morning. my Hello. good

questions, One the the optimization on follow-up of just trial the to in hemalignancies. basket dose

the And those substantial you. to combination both the there's with be anticipate you dose the sort And going study, Thank is settings? you thinking about to this also study, then XX be a are initial the how going optimize dose necessary or this do there? [ph] combination? like in is be in going efficacy monotherapy two said in additional to to you of you signal If baskets aspects do in a see one finding combination of work of these

Shefali Agarwal

This Yeah. is you. Thank Shefali.

heme study. with start basket the me Let

reflect So studied just on think the more to than clarify in optimization we dose the study. X,XXX-patient optimized at that monotype I and dose milligrams to we XXX just have want dose I the

Of together. course, the you you study look at two dose and the combination

like this. have the we have these based do be done R-CHOP So multiple is to and a with be able the Based do done run-in studies combination on with to on with able escalation to doxorubicin. we early data dose combinations on and trial then that goal safety the

different We as have have showed there well. highest of inhibitor, formation with showed where dose the with R-squared can XXX so far showed that that we combine milligrams. we at we a that are We done checkpoint

know that as in So the mentioned the I different signal Heme combination do goal Basket and we see we we different expand multiple cohorts, escalate to think in can terms to would Study in be this able the the indications. that of once

study, maximum first-in-human to the optimize you is your the know X first-in-human really efficacious the from dose or study understand of terms In the to dose. study MTD as beginning

then really would able great we because particularly big in In preclinically it in in call goal we need which may the t(X;XX). in a the find there's first that have to is multiple believe So monotherapy effective to escalate be monotherapy, be t(X;XX) we showed data unmet myeloma. in the that and dose expand recent where

also have we Once And we will will we different in absolutely about and monotherapy, the multiple in non-t(X;XX) information the studying look t(X;XX) in combinations indications as expand myeloma. So monotherapy. the as more. as those signal DLBCL well at many

only I as dose think not also as life both said, plan, have have great but [ph], well for TAZVERIK to cycle we life cycle I for a a as EZHX So big plan. optimized

I on think overall, so XXX I safety the we feel milligram we course far optimized want run-in we the dose. that data then based in the comfortable look have chose see. is to of say But our we at that that combination

Joe Thome

so Thanks Perfect. much.

Operator

you. Thank

David next from Our Morgan Stanley. comes question Lebowitz with

open. Your is line

David Lebowitz

very question. much my taking you for Thank

Rob Bazemore

Hi, David.

David Lebowitz

Hello.

Is population resistance the dynamic getting patients do respect forward? the vaccinations, vaccinated? you dynamic within that see multiple -- how going patients is with how myeloma to itself? there And with Specifically getting

Rob Bazemore

also a this, of from Yes. in It's turn I'll a standpoint David. physicians the trials. with but of about from she's commercial that over to clinical great question, interacting both because view, been interaction Shefali, point our

to that to Shefali So answer. over I'll turn

Shefali Agarwal

interesting And elderly vaccinations very be would lymphoma, other all Yes. patients follicular hemalignancies think multiple get or myeloma patients want David. especially a morning, would It's able we question. as vaccination. good to as get would to that well Ideally

have the there's therapies the antibodies because a some as that the or not about to you from you have all, I'm majority to well but you is, because physicians getting drug, is I you about rituximab. of are, concern ensure having as with are And the stop concern as know, hearing them vaccine. think what have immune antibodies

increase, that, are therapy. actually all They of want fact that So is the therapy. patients continue vaccinated, to getting an is not there stop but on to their their what we because don't want hearing are they

it in may think be I and So may eventually future change comfortable. patients

lymphoma, they're in the if very diseases to stop I think, but they ones the follicular less aggressive therapy, to have want vaccination. multiple that their in don't stop and get especially aggressive to more myeloma they it's at DLBCL, you or look

in So how it's I future may see We it a mix. think changes.

David Lebowitz

-- How long do firstly, take on you guess, think I dynamic it shift? your this

Shefali Agarwal

think to comment. hard I it's

medication comfortable data if a the rituximab, long-term get the of like stopped As okay. with people for and Even days it's for they vaccinations couple about that. still

we'll is a as gradually to improvement that physician, I increasing that and how years. hard they Yes. It's think feel I it'll doctor comment coming but that it this better. become long in see and feel year

David Lebowitz

many or that on have Have doctor's of of how level patients vision some resistance? estimate sort given

Shefali Agarwal

physician just to what kind after some I physician get say majority of want They the physician, that talk number. I to give they because vaccinated, say patients don't. is the is, want people would you as the but better give there not anecdotal, don't all They very that to It's of really stop will individual quantification start patient, and as therapy it myself But I'm take vaccination. know, vaccination. But a hoping, they and this whether will taking or on depends eventually anecdotally. get

David Lebowitz

my Thanks for question. taking

Rob Bazemore

to as this just maybe in Shefali that comment even -- will we seen, follow on and But David, but on up haven't well, David,

Shefali Agarwal

Yes.

Rob Bazemore

open, the with as study. of XXX optimization. mentioned, where we great Shefali wanted enrollment as nearly with optimization and that we're left because open, patients left ways enrolling work. part But were additional that the dose potential dose a finish And the it see a the we the agency study in patients discussions So, XXX can about in as been that FDA even we for in the interest there's in example, complete we to

ability not we've XXX, impact enroll on for seen to So the a significant it had example.

of were we're is to be in us. patients So to these many really Physicians relevant are XXX, patients. about That being what vaccinated. her with would how it's more seeing treating comfortable which terms impacting point

Shefali Agarwal

Yes.

Rob Bazemore

want to further on comment might Shefali that.

Shefali Agarwal

Absolutely. Yes.

R-squared I study, the the enthusiasm even lot seeing study. in think of R we're a

your patient if overall, is back come physician the will -- the think, will the question whether I and take therapy. come Absolutely.

change doing I think it will that. people started gradual have and be

us are patient impact safety the We domains Actually no study. XXX on said, even seeing differently we the Rob in asked had before FDA the like enroll, for number.

therapy, I or that not. coming So seeing interest of think we the for are irrespective vaccination are patients and

David Lebowitz

you much Thank Excellent. very that. for

Operator

Thank you.

Our next question Leerink. comes from Andrew Berens with SVB

is Your line open.

Andrew Berens

Thanks. Hi.

Rob Bazemore

Hi.

Andrew Berens

information. that the be frontline will in said number presenting now gives to type treated A better patient for when Hi, is also those mutant alluded session, one said then And you fair And of you A actually on couple for you questions when What's of tested? to when a you where clinicians know up the Rob. have the you questions testing. questions but that with think on be to patients pipe. a candidates then, get actually EZHX, TAZVERIK and EZHX on that in on the done on And the of long bottleneck to want because taking do prepared versus that are then how status? getting it and couple you did of sequence patients visibility a channels, start I follow wild patients limited comments? patients testing Mohit’s are being type the happening? How TAZVERIK? unmet Q&A that thought in to access And usually being is I of

interim until to a analysis what you question wait on of answer getting want questions. type drug those are ask sense wild actually So, if then versus you percentage now to that the trying patients or do I just the And me after or get can of mutant. that the I can

Rob Bazemore

ask what's one first questions that about? There Vicki number one-by-one tests. -- own through But or miss as I'll now don't for their it that your have on address first XX a if actually let's them to comment and I'm go doing anything. the the spoke Let's well then we can and why testing ways Many was, bottleneck Vicki so they they test. and of the are percent are how institutions

academic are panel. foundation all other There quest those of if using on So that panel. are There available. a is physician panels them. have diagnostic an that's many panels physician a commercial a institutions their are medicine There's EZHX

there EZHX. so test to are can many for choose physicians And ways different patients

many, the don't had Vicki indicated if a institution, what on institutional many Those to not access you're an panel. community you're physician tests panels have you think is, commercial them. in I have

is do ideal. have what for so that that so access panel, today. a test have are just they desiring not is specific you but EZHX, complete actually do really And they that It's just to panels to don't

is bottleneck. so things test we EZHX. looking is to That's can one TAZVERIK. for who looking choose even Getting not always to physicians the things make But see that of they're it's simpler group patients on for tested of And bottleneck wouldn't a who specific we're the that test want or for reason for if a I say patients. going a that

in start I I I sure comment. line? other the want what first in when or right. didn't did And heard think we starting the quickly testing line? see make I you When to just first use was seeing said question restate are your to you we how

EZHX tested the is index. the of So of patients there. I'm in first used one making TAZVERIK parts are severity line. The the unseen

patients of well-known be around just But score. we one more they said, disease. two And else you'd as wasn't because their to it's it's test of to Vicki the that of as relevant a new frontline, so physicians because one a there's in before that the wasn't information piece it's obtain disease piece anything or could diagnosed one things? information those brought now TAZVERIK market. And severity add about new it now a Vicki their or that and also part testing of the testing reason part will is newly it's

Vicki Vakiener

it covered you No Yes. well. Nothing.

Andrew Berens

period where And be started responding they the the treatment. obviously, just there's I'm second to And front a in they just patients tested frontline. will Rob treated I tested. being didn't frontline being mean being in and curious the line when

status with do start TAZVERIK? EZHX seeing So candidates we'll think you known patients for when being

Rob Bazemore

it's great point Well, a Andy.

severity so we've to that's flippy And in some the grow a time some the part I then and think because seen physician testing it's index. starting of again for frontline

time with that combinations means other been frontline allows for line, and already testing we're think in be since that could panel. relapsed, setting. second for squared the for of it's growing, it's Rituximab when we label as tested But that that good that as and a it very been as it's TAZVERIK status they particularly second So could approvals say in the Lenalidomide second would some part our TAZVERIK long mutation more EZHX because patient because use as the a monotherapy patients like encouraged I of early as the full mutational line seeing we're particularly R know EZHX that have line the attractive

can months. within who we used start how expect. just frontline point terms just And because prognostic have first go It's you so long tend in months ones mean, POD thing. it's of it but would a just in the you continued And to how good to of progress with a before from that's patients grow, may setting didn't And then many XX often I XX the patients relapse. for they view.

depending pretty patients quickly there's to treatment. their a line their response on those second from of to initial wide variety how frontline So progress

Vicki Vakiener

other wild-type. question was Newton your And versus about

Andrew Berens

Correct.

Vicki Vakiener

to answer that. happy I'm

diagnostic for the what we as still as predominant look drug. get line data, now line data was we Isn't are for Newton we claim wild is actually when right versus use don't So it's at the TAZVERIK we've setting second fluff type in split the claim's well through the And in well. mentioned claim as the because the seen that the in third is the I as seeing piece. use

that versus do providers both your we that prescribing. pretty line Does seeing answer we what utilization seeing type. with is we're the and in from are are setting research we class market wild third have mutant second And line that what extensive question? to So the that is do research more

Rob Bazemore

that higher in – Andy, I that monotherapy think we we always share would a that the see think yeah, assumed – have mutant that would a be I as population.

didn't Vicki don't the consistent that's what other the we don't need we that, then test which physician So is entirely And expected. test. untested has mentioned is group which to know require policies their because would the actually with there's and feel have to status,

Andrew Berens

Okay.

would getting you it a than positive say the less So it that EZHX or that? or XX% are patients TAZVERIK? is Is number

Rob Bazemore

tested patients think I because Andy, it's they and are. to the hard to say, it's for which know they're those difficult

Andrew Berens

Okay. I'm And just then -

Rob Bazemore

That's driven claim's the data.

Vicki Vakiener

Agree.

Andrew Berens

Right.

the R-squared on should Okay. second to we interim perform? bar the how is that And wild arm patients? high get question And the type then, for the going trial regimen? Just EZHX TAZVERIK for then how to control or analysis the of just be expect trying a OH-squared for a to sense is an mutant

Shefali Agarwal

is Yeah, a Andy. Shefali. that's This great question,

So have are spent. so very study, actually we to a a is there we in little testing see we ensure, the is alpha success hierarchy doing the way so the that interim

on population. once mute that is the EHZX our and then we're what positive moving So starting to

mute with we be of is power enough to both at is then EZHX our goal study events its mute population that we mute or ensure that the it to for population want have look able can own and test powered the overall So to to for them. we EZHX EZHX on and if

of adaptive because Andy, augment the in that different. So that sensitive only that experimental know because it's the the And metastatic little will a the competitor. how at did was looking why endorsed That's a behave, design, lab goal we the terms interim. study is we patients,

because the patient the that's population, real about the patients. enrolling are world of TAZVERIK We refractory XX%

adaptive are to anecdotally arm not are hear R-squared. will those is to patients that physicians When the see from treatment being we we less, an they especially the behaving. how because going competitor with believe behave that the responsive insurance, So

as plus interim an And this placebo. arm. the look So overall the the another that maintenance behave study of after experiment augment and have different the actually we is opportunity TAZ And really R-squared. tasks to the look at have how that arm that's component arm PFS the as believe because is also we at we maintenance at study will not arm their PFS, than R-squared per important of the to is year maintenance of we at look task will compared a benefit

innovative So it's a very design.

a be your able have look to things assess You at at these and all regular and accordingly. an to opportunity adapt interval, trial

Andrew Berens

Thanks for letting Appreciate me, it. hog it. all

Rob Bazemore

Thanks

Operator

for back closing questions the Rob remarks. any Bazemore Thank you. the in to to I'd no like showing call queue. And turn I'm other

Rob Bazemore

for Thanks hope thank the you all Okay. great Thank you, a you day. us and We today. for all and and stay care. have operator, Take joining all healthy, that, questions. safe

Operator

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

disconnect. now may You

Epizyme (EPZM) 8 May 212021 Q1 Earnings call transcript