EPZM - Earnings call transcript Q4 2020

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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

as This the a Operator. and issued press the as a XXXX can today's Thank found website be update morning, at in providing in well release press business results. Section quarter to addition release accompany financial call of you, Investor That Epizyme slide company's to full-year fourth epizyme.com.

Matt today Chief Ros, the and Chief Chief Paolo Tombesi, Financial On Chief and Business President Commercial Vice Strategy the Medical us Executive Officer Shefali Executive Bazemore, will Officer. call President, and and for is Rob be joining session. with Agarwal, Vakiener, Officer; me Officer, Vicki and Q&A Officer; Chief Dr.

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

Rob Bazemore

five to has that our us our the a history had novel achieving signals entirely working and and a our of today. all TAZVERIK through living enrolling rewriting Thank year at Epizyme call reflect was is the I'd physicians and for of all experience, of none toward while to very Epizyme with shareholders through something joining approvals back-to-back them, medicines. FDA we like XXXX remarkable us treating execution to to reflects trials, treatment you, on Bill, that epigenetic this progress people level and mission cancer, take within likes of two that our months, the ever thank for pandemic, seriously. you clinical launching for pivotal to encompass cancer which mission remotely

For that, our Epizyme. here incredible employees thank at I'd like to

quickly environment. because we clinical our efforts to new brought and execute challenges, all And we teams successfully all XXXX the to indications. launched tumor first our people our solid to perspective, it's were Epizyme cancer, sales, clinical that into the transitioned support and and of initiatives. the pandemic research many and adapted solid to with living access across global their of our a we them, to our malignancy. physicians, theme epithelioid Despite as development Our ability label additional of FL, following advanced accelerated we product approvals a TAZVERIK sarcoma, fully a in follicular a of integrated From in enterprise, commercial able cancer lymphoma, common expansion tazemetostat tumor

of all time, fact, were our of XXXX achieved In clinical or on schedule. ahead initiatives

hear year. our We early about pipeline, to you more to progress can expect also continue this which stage

runway into raised important based our we and plan. XXXX fund operating addition, cash our operating In initiatives sufficient on growth to current extend

there community the guidelines EZHX approved both year was of only use and The ES was clinical TAZVERIK inhibitor first oncology of on unknown. treatment specifically before market. ES the last month, is alike. This utility TAZVERIK first no EZHX the were relapsed prescribing insured in and has acknowledged and TAZVERIK the of of the the over for clinical education for reaching reinforces to community. and and the approvals quickly two label patients efforts TAZVERIK, FL Our indicated made to recommend ES amended covered in conditional. Within but face that FL. for In Today, payers our FL current been is Earlier anything incorporated guidelines FDA is weeks line whose lives for that are in EZHX refractory the by indications. launch our pandemic, KOL and the U.S. patients, status TAZVERIK for this the the requirement the TAZVERIK practice supports into with three status NCCN XX% and of NCCN only in revised in test is both patients which recommendation the approvals, TAZVERIK COVID

all quickly has ways to adapt possible continued to by to as finding that with eligible commercial virtual reaches engage academic team as ensuring the environment, community Our physicians. TAZVERIK new patients and

academic greatest saw centers. large adoption initial TAZVERIK expected, to As the of we

we're awareness seeing our label as many improves. of among adoption the So community physician practices broader now and understanding

described the ES for cases XX% the in extended last expand. of year, FL the TAZVERIK quarter TAZVERIK challenges revenues the COVID-XX increase resurgence over we that of adoption and in quarter were net adoption continues FL. in While $X.X by driven to a increased fourth primarily million, fourth QX,

these of overcoming to and patients our and access execution signs this positive see novel to continue have we commercial revenue, challenges drug. to ensuring Beyond approaches

I'm the increase During new I'm quarter, XX% momentarily. and will the pleased prescriptions I how we by success joined encouraged prescribing to-date. observed Commercial our be Chief elaborate by in Epizyme's potential given Vicki who to on and Officer, Overall, commercial continued a and circumstances we our the TAZVERIK accounts, enthusiastic executed grow for remain new monthly TAZVERIK fourth increase to for in Vakiener, largest quarter-over-quarter about long-term ES today FL.

plus run-ins throughout further milestones ES I trial political advancing develop made our progress ahead completing tazemetostat As earlier, programs of safety we've of all schedule. enrolment our completed We time noted or the to on doxorubicin second-line XXXX also in trial of moving efficacy portions in patients. later tazemetostat forward to initiate confirmatory these tazemetostat of confirmatory expansion and plus FL studies. RX We're in trial our evaluating now for both and frontline patients evaluating

also marketing Our on remain first FL for commitments and track. ES

currently safety all in run-ins this plan early mechanism year. safety with We completed of study safety Abiraterone. others XXXX, in with as run-ins lymphoma and grown, being cell collaboration report B Atypic collaboration combination diffuse many approved in the and data or Study FL, castration metastatic has prostate interest of on initiated Studies to cancer in patients frontline from large novel tazemetostat of also evaluating trial sponsored our studies which investigator or portion Association under the and Lymphoma this enzalutamide resistant was the in several also expected. working enrolment as we in activity in to trials review. tazemetostat such are tazemetostat in with We continued enrolment enroll three

As XXXX, we four we forward that Epizyme. there driving long-term for necessary into growth to and believe beyond, sustainable pillars enhanced and are look

many to of patients ES possible. appropriate maximizing our first, adoption ensure as and commercial The effectiveness FL in TAZVERIK as

into living people well cancers pipeline ES tazemetostat building potential drug beyond importantly, benefit to As with FL. and

into also a value oncology oncology bringing and working our expand responsibly. will portfolio transforming increase and and reach resourcefully novel We collaboratively development and And leveraging clinical finally, patient available shareholder into true pipeline, all options expand therapeutics company. to Epizyme

today's Our we'll will Time. Eastern focus Tuesday, call results hosting Epizyme, to fourth We're unveil the and a March these AM for call to episode of quarter announce next on XX the that at first pillars. be o'clock our excited four X, next

further this, deferring advancement the Because five-year plans, and be regarding related our speak development our we'll we'll of further call, the next much of updates this about relating expansion provide discussion of to data detail provide provides thinking TAZVERIK strategy, epigenetic During to our to will the in pipeline, this to plans call insights next week. ongoing we But and milestones, years. with areas next focused planned how along pipeline potential clinical over five and we're our into trials, new pipeline.

will turn And XX expect about with call hours. see we look call next the in the this more like You your to participation. we And for ongoing followed I'd Vicki? to over open information to our the year-end forward to call should that, additional launch Q&A. who Vicki, who'll on before color review provide our briefly by financial, and quarter fourth efforts, Paolo,

Vicki Vakiener

progressing accelerated significant during we and rare the we'll disease have approval science TAZVERIK pleased that and extremely the solid trends indicated priority the after opportunity in and dialogue Rob, to people in Pharma, sarcoma, both way specifically in effects lead or We we an team ES, roughly gain who world virtual to only from of encouraging came importantly, addressing our TAZVERIK an good this the FDA the cancer XXXX. two January and the TAZVERIK in pandemic. epigenetics in our long estimate sarcoma, for have promising the seeing in After XXs now, become epithelioid we join Epizyme I here people their of familiar started cancer. we launched COVID-XX more detail experienced focus prescription ES of receiving the awareness is driven and Thanks, in with progress came as medical in-person to the for both with Commercial treatment with this Officer, by TAZVERIK the XXs. I in specific hematologic greater uptick as the we're follicular so or morning interesting primarily epithelioid disease us have to decided approximately the with of recognized months need have cancer, tumors. lymphoma living are there We've in help metastatic our people accounts are Chief that and to Epizyme's seeing full XXX tazemetostat quite the the introducing everyone. first observed the XXXX, privilege who the go on This medicine traction, This been a that and with. bring to before because patients. We rapidly fact people of provided ES, diagnosed specifically And as adoption which because an and But with shifted before U.S. morning, with and efforts potential to I strong we first faced at TAZVERIK. of on XXX the it's given I had initiate are environment continues to an Big were indications. half traditionally into here and all challenges along we're ES in and a career eligible with COVID. affecting

year, began to transition in of the plateau. we half growth second As to ES the

II third quarters, off our clinical duration to therapy with average therapy fourth shown TAZVERIK disease new Phase relapsed the While we in continue four patients with for an see of in and months data treated between of therapy refractory and later have second-line later patients. five with some cycle patients began multiple lines to and early Patients starting consistent of the treatment.

of usage all While we're third-line significant or need has in second treatment seeing the of due the to in patients therapy and across later in been TAZVERIK ES, new of setting. lines utilization the majority initial for

want as XX% familiar education TAZVERIK therapy. line to is bringing we our team, of want Thanks to in following QX. of efficacy, to ES showed become treat in To expect this to TAZVERIK limited of be months ES, with physicians approval. efforts this year, awareness that and positive lines we're ongoing wrap-up, are will earlier continuing utilization has setting patients expand patients to grown focus favorable treatment physicians the reporting the with first over more most medicine to initial where we As these This of exactly experiences, the I that emphasize to for our more where the benefit clinical data providing options. on to among

treatment earlier we of increase duration of well. As lines use of as TAZVERIK will therapy in expect expand,

the Now oncology with to from FDA Last ES, a our Unlike launch this adult lymphoma approval. a pandemic the for patients FL follicular was treat has FL. during June, we TAZVERIK required of progress any in approval to refractory or start, obtained accelerated obstacles. number let's FL since launch medicine turn overcoming completely our virtual launching relapsed second

there have challenges. team, distinct our been two For

visiting are the general the patients cancers age their with of other compared to First, which less disease in patient of accentuated the frequency, is population. due doctors the and with indolent nature FL

first and down again. remain recently started visits visits patient to during that the pre-COVID While encourage quarter, they levels, practices reported compared in-person to have physicians

XX% our to to treatment for level, eventually patient This broader new new change starts seeing will However, now. these improve patient's impact reluctant quarter any this without approval, had TAZVERIK XX% compared which patient FL change patients been in-person. ability fourth is on the have to that many believe a in as most of we with physicians following therapy continue treatment and are on an for reduction obviously given our their to gain but time some therapies starts pre-COVID has vaccination without see we in to understandable, a

in been our staff. hurdle with entirely face-to-face limited our physicians treating major launch and has second been access field almost their The has teams' To-date, FL virtual.

virtual have able accounts have teams in stakeholders setting. tier our our been reach access been of is of reach other all to challenging, physicians their ability accounts, to While efficient top less the frequency and to

here's to case use physicians medical speaker on events, local multiple as these in this and for the require in otherwise innovative programs with for two to a allows physicians. with active person. that with And can patient the time with efforts label to while our an have very groups It patients focused participant education workshops, support novel We've be programs support So of statements. their We've programs empower and thing. the has program. care. non-personal broad such in indication promotion FL, challenges, with explanation taken tools on disease advocacy it and formats, virtual field interaction focusing programming of adapted relapsed the partnered peer-to-peer unique patients to team's might approved initiated awareness compounding get more traction be we educational given in TAZVERIK some refractory number To address than

presence by that focused in are a professionals our We have online healthcare of also and investing on social all and diverse increased traditional mix digital patients. reaching media,

of a patient the highest December refractory with of coming new any in growth quarter, We all As and therapy. context XX% treatment. In But the new patients with third we highest the also pandemic, prescribing been in later starts fourth we use the relapsed we're where with from which the growth. over our pleased individual especially third-line our see the grew has in EZHX of TAZVERIK sequential setting patients result second-line this of of from number is largest in with share efforts, quarter. and exited accounts recorded lines growth the share mutations. The

awareness in free grew revenue goods bottle goods the team's assumption same charge reach XX%. eligible team Annual new XXXX. utilization this presented to our to XX% increase including December Program for all accentuated common we're Patient been patients relative in of TAZVERIK While committed economic of December, irrespective total and working professionals was with The pleased increase, need, person Patient has approval has and free than see by the remains goods, to COVID-XX the created given by TAZVERIK percentage demand, ongoing our without overall voice with has status. care pandemic. challenges health XX% achieved severely some Free in share in more increased grew Support helping Program period, Overall, from seasoned of the performance which line physician therapy. intent means since the for free We're is Assistance field free pandemic. in the by the companies. it impacted others of mutation conditions the in patients for highest to were providers goods EpizymeNOW, prescribe in the virtually pay to was to FL. provides TAZVERIK high, and of our patient's which to ability But Even EZHX with

mutations, creativity. and to community for EZHX as continuing academic to in activating TAZVERIK. Utilization grow EZHX, wild-type tenacity we're Our seeing being untested more teams with FL and approach reach remarkable prescriptions expanding well have patients. to in continue written is adjust for adoption now accounts, are importantly, shown of large prescribers their their patients and TAZVERIK prescribers as

data What's by amendment continue guidelines status recent increased physicians for relapsed utilization we'll and that we FL has are indications. in prior for TAZVERIK re-engage with the no very is aligned this currently insured patient the to XX% And patients. NCCN for ES and and they for refractory usage reflective satisfactory our majority TAZVERIK the more, patients With of their earlier of label. continued U.S. TAZVERIK by population coverage to lives of in the in are EZHX expect month treatment supporting positive covered authorization patients both FL recommends with our broad whose options, use physicians. TAZVERIK see unknown, of as payer to be requirements and clinical generated Over

and physician TAZVERIK, benefit prescribers, tolerability we safety community patients profile, persist can to educating a identify continuing due we're expect challenges focusing ensuring and from what who new experience. attractive TAZVERIK, academic control: in to the about positive on and can and accounts While growing appropriate pandemic, we physicians some to XXXX

to call questions the pass to over to results. Q&A. during Paolo? your forward I'll about our addressing I look financial Now Paolo talk

Paolo Tombesi

the very and and in a Vicki, cash morning, good in securities. cash, with closed strong you, year $XXX.X position Thank million equivalents everyone. marketable financially We

our non-GAAP employees R&D Non-GAAP expenses working we reduction for $XXX.X operating million and total below expenses as $XXX.X spending and continue Our respectively. of were due $XXX.X operating SG&A million and and million carefully a majority expenses see to guidance for the XXXX manage in were approximately travel XXXX virtual. to other

ES and includes full-year million recorded we revenue revenue. TAZVERIK and of which of $XX.X $XX.X sales collaboration million XXXX FL revenue, to of Turning net $X.X million,

fourth recognized in collaboration sales TAZVERIK quarter, Celgene. we the was included of and net million, revenue, termination $X.X recorded $X.X collaboration which which of with deferred For the revenue following the $X.X revenue, of million million agreement

Our loan $XXX cash a in strengthened of position through fund will quarter balance was commercial tazemetostat was additional and executed and initiatives of efforts further our strengthening early facility our This planned November. Pharmakon tranche indications in research execution, for growth Advisors in a new the which number with continued sheet million fourth and expansion combination regimens, critical pipeline. including and TAZVERIK ongoing development Epizyme advancing our

reminder, million by agreement facility expand an $XXX the option a loan following we retained additional As to with mutual the Pharmakon.

launches, trials. to commercial to expenses continuous expect and We of of development including ensure in for in supply in capabilities uninterrupted investment XXXX, to million $XXX clinical our clinical additional non-GAAP commercial million for to the patients in be operating adjusted manufacturing investment range support $XXX our TAZVERIK

given for the related Finally, COVID-XX We're I'd and cash our for support turn are early stages pandemic. moment in to like financed into cash to any the XXXX. we're over our launches providing Rob to and call operating current comments. uncertainty today back guidance the evolving revenue equivalents closing that to the with not well plans Rob?

Rob Bazemore

not you, well of where executed exceptionally by FL Paolo. our year all its confident without in to and remain patients and long-term Epizyme the Vicki TAZVERIK things remarkable challenges, we progress was lives a the living potential the and for with Thank ES cancer. We're launches encouraged in Well, XXXX change considered. of

you'll we open March our we'll we our for Epizyme. next now to join X, on for Operator? call further where the episode questions. to us vision next reminder, Epizyme elaborating for a five-year discuss Tuesday, hope As will next the be that call And all your

Operator

Instructions]. Thank you. [Operator

Our with Michael the first Yee Jefferies. from comes line of question

now Your line open. is

Michael Yee

good for update, Hey, Thanks morning. Rob. guys, the

Rob Bazemore

Mike. Thanks

Michael Yee

is one two that out that When I think the the I've talk information the you quick block patients second things it's of usually one important you that physician to that. demand up tackle get about is questions. color Yes, the launch. think prescribing of the all question. finance to then a those need launch, gave most pick is bit. keys. it question around you Do appreciate and Maybe just a on better a are or really to just reimbursement think us And about you

guidance, to able you Is so be do I line? Thank you real maybe might you does nice $XXX have There line? it that credit just some to financial available? be credit gave really the at much. is I just where OpEx remind you some have remind math that around no me Can the How cash, that You work? that. hit about us to on do think you you year. Can can current end of just million criteria,

Rob Bazemore

with let me first certainly the start question. Mike Yes,

that's unlock So to today, right and thing we market demand it see we're driving now, how regards in where this. performing what's to needed with the

and of the to access policies according XX% we remarks both announced patient is it in to cover be we yes the terrific continues covered all, of those ES, that lives for label. payer FL opening over have First

that use are as that month, requirement setting. line to no testing, So it for second-line guidelines NCCN of the label in were is encouraged the all according says. for early label the We for that allows there this as updated are the without requirement earlier testing even to second that reflect the things

that patients, So are unknown, policies testing wild-type patients and in payer choose without to who who mutant can either use do those TAZVERIK that. cover or

patients. to the we regards that. the is We with new call setting the patients actually adoption, exited a in later where we're predominance seeing higher seeing, actually the the the than in our the product we're pleased mutations. of as that well data category in predominantly also and second-line think with setting, is, said uptake which line year I of we're And any growth share the who Second, in and very third-line, prescriptions have at on that in EZHX of other

substantially aren't So a visits that than months difficult that's their had patients the coming if quarter, that great time we've different really patient six in a where seeing be We're we physicians. comes challenges launch, so the a see was to And into communicating still physicians. the in down with place to think I the there fourth are it third quarter. not feel

if fourth a -- starts prescription remained quarter And in so look get at in it's the in in the down patient for the you in refractory start XX% second-line setting, and that need about compared that the order new to third-line to we and population, relapsed patient XX% the prescription new pre-COVID levels. later. for XX% any product third-line Overall, if to TAZVERIK setting

TAZVERIK a prescription written to have So the new to for to opportunity be written. we be have for

some key or the quite where if launch. will more year execution. physicians the than that five in calling that this therapy wider about are, way use of forever, and disease unlocking these isn't new see lot with need the it's pleased that the that time, they having of really these vaccines, itself, TAZVERIK they're experience, it, they this if in so progressing. we envision. if a a growth from bad the been But get we to can are patients is trying We're months correct And that their six of their is initiate really them into so physicians to said many a and And we now for as back before, have quite patients the we've of away with believe

to Your with second financing. had question do

cash a loan specific extra remains strong our we about position. into million $XXX asked facility, is in position upon that financial between But an there option. no We're in Pharmakon it's to as to that, a should to is said, position second be use we're the decide There us not of mutual to the are this has The that. that triggered criteria XXXX. going into be have solid satisfied year and specific it. in criteria you consent purely we for tranche So that use order the

Operator

you. Thank

Our from next the question line comes of Yaron Werber with Cowen.

now Your open. line is

Yaron Werber

Thanks Great. taking my for question.

I So Robert, got maybe couple. a

is annually, is The do question, volume are can failing following third-line you the Mike's of of bit any a of in of we give in many sense obviously little mean, sort have down us from standard kind context, put first one sort care COVID. sense can a of so I how you patients

$XXX you money And you on do can, that? have you few SG&A, how sense, kind the on -- million much just wiggle maybe, based little that how a spending out employees, doing a then get your of you starts is kind and overall maybe bit the hand, how on team now your are give are this overall the putting well if team where a encouraging you're right of in environment your secondly, we us and Thank mates And actually on opportunity. you that sense of one those the are So new pretty message are up relative there impressive. the That, you. buckets? and with to getting room

Rob Bazemore

Vicki maybe as on ask well to me add patients of Yes, color a that then and Yaron, start getting. we're I'll bit the let

is market expect there, the third-line it's So of those later differences the we've often in plus in. matter setting. or a how patients size, this patients so and those coming market any last don't around XX,XXX of said We size always of which refractory there are X,XXX are

would as agent getting of getting based wild-type. As single of the year second-line and population on always new we've our we the of patients think mutant you the those seeing. just than a that would our wild-type. end share said, share also in that data that's strongest. our data, patient we in in the prescription patients patients be patients more a And higher fact, We're any mutant And higher seeing, expected in with the share the the the in we're space. we're where and what the was expect use close I predominantly said, in EZHX But well as mutant other I

volume generally add so the from. we're what a patient far. in to where so ask And Vicki coming more And is I'll Vicki? that's bit seeing of speaking, color terms

Vicki Vakiener

great. to Nice that's Yes, here. remotely meet you,

the we're new of XX% comments, XX% Just at is share was growing new said, to and utilization. as the not which, -- between fourth for quarter we're add Rob that Rob's our fastest new drug the therapy, or share, the patient shared drug quarter or the X%. in of terms -- I know estimated patient we for third about new to time in And we estimating this

pleased growth. -- we're that to So we're continuing that that with And very see

Rob Bazemore

to the is XX% -- over the -- That XX% quarter. average XX% the

Vicki Vakiener

the over quarter. average Right,

Rob Bazemore

obviously that. higher than So

Vicki Vakiener

Right.

So we're that. pleased with

the think are early institutions And these TAZVERIK community are The that XX% really is is mention community prescriptions were on, practices academic as the XX% about on we've to signal and starting patients point I positive and other to continuing a seeing academic that's of to academically fourth is And come to quarter to thing were the we our coming increase. which in that more. online split, XX:XX based utilizing where now want is split the I another from, prescribing based you because more know, seen community.

to we're as that's seeing fact growth. that's finally important going and the voice we're the that of it to community continued -- just as the share really So our is for high that getting intense prescribe and

that. with pleased very feel we So

Rob Bazemore

and point the reflect field-related pretty had expenses talk But our that uncertainties specifically to managed on then expenses eliminated pandemic, lot to and And just about travel expenses. the ask reference in maybe tightly question, expense related, remote XXXX the for a to SG&A also a environment of start our then Paolo the the I'll component. the we already working

tightly that. managed had pretty XXXX we So because of down

That And launch follicular XXXX. we'll June investment being in we've launch with compared We was expect reduced flat follicular XXXX, the also, -- of held date, six we've XXXX, in basically accounts a a month XXXX costs, most some a full-year expense to have launch said, the fixed launch. in lymphoma. G&A of XXXX we lymphoma and our to of now is, had this year of return in for the actually for full-year held FL fact, that in we've PDUFA flat

also trials, in Phase our studies So efficacy into need support XXXX, is question. clinical run-ins manufacturing then to Paolo, clinical of Yaron's expansions, G&A new we'll to transition know more the portion safety the color a in and our clinical that right. largely to the the III as I add area of bit like areas support our demand, grow and don't you'd in if investments trial our on full commercial

Paolo Tombesi

already sure. you answered of questions. most Yes, Even though the

So well basically, quite managed already in as Rob said, XXXX. we

if on difference product. announced full-year exit on so look still because is The is launch the a -- We we you that one at XXXX. QX, full it, increase really this the activities. significant launch the only So the but [sic] rate, morning in potential believe not we of annson still just of the we reduced and there invest

actually full months last sales reduced the in last Our XX started force But year been has to further March. SG&A now compared is year.

Operator

you. Thank

the Citigroup. comes Our next with Bansal Mohit from question line of

now is line Your open.

Mohit Bansal

for these Thanks taking all my for thanks question -- providing Great. and

Rob Bazemore

Hello, good morning.

Mohit Bansal

morning. Good

do -- math just So there. so to maybe some trying

market, by quarter XX% analyzing the think new $XX you I, that gives a even being COGS. to share for obviously, early. $XXX at for new about run if it $XXX But patient market accounting rate, million annual number at million if million to $X.X at XXX%. this still I about million even increased looking me is XX% So get COVID, of only about XX% it's And

understand, trying just sub direction, this still this but I'm in everything in like like mean, market $XXX think going not because that sales. the translating segment? I it is it we does to seems into So is about should mean million right opportunities How patient

Rob Bazemore

third-line mind, in the to considering so in our Again, is respect size. Hi, just changed Mohit, market attractiveness market in for you market, this thank XX,XXX and view in no, the And the all, hasn't the look at the to with or XX,XXX that, question. the alone. of keep market TAZVERIK fact, of

patient population average portion tend once third-line roughly to estimate over We The turn that patients. a of on on is about year patients X,XXX that those average.

drug we're as have course point, That's a and means they're quarter. would that of number third-line to the because patients, if just changes at later those that that Keep entire treated numbers they use therapy. in size that mind annualize the of revenues. appropriate size, the some you reporting So the are over an be always market of that the

the would XX%. by a down cycling by It XXX it plus that was be year. It through XX%. by new more don't normally of remained that month months number per later benefit earlier quarter. even patients came the remained at therapy. assume the patients down down in those than That's the that's But roughly patient and if they X,XXX, have third-line some end that, the sales, But three that population So in that's is of of you of -- roughly XX%. down if the

patients they're overall size affects doesn't of but that also of the the not those not it a have -- market. we It's not the them, new coming So it access size the the change market. treatment, on don't it's But to to are if size.

already to some of are patients look let total need value speak the coming When be and brought talk basis, XX% with way the Shefali to them, be patient of the new you a bit But she's I'll seen, with in. expect a conversations the that physicians starts share reduction bring have what is total now away annualized that more are are will as they're back Physicians said, ask have indicate to a months. said. consistent to population, And that back having a of the to the we've about Shefali, that having of happening it's starting they realize month-by-month look you eventually need back. they I size if to come Again, patients that because getting We many patients on they bit because those with limitation with now. longer many in you maybe been their at patients that at to of in trying those right. it they're why having of assessed. also for just and that conversations patients start I'll a part you it takes

Shefali Agarwal

Mohit. Sure. Good morning,

because we I little know, second a then an a COVID, academics around increased third little the as the important question, of bit. again, little the it's you June, number very quarter surge. the and community talked especially to bit, bit very, had both think it I But visits in was because of physicians, April, actually May, low,

to it's of patients, because like to don't really are of And elderly and to only they they'd it's the these and hospital, clinic progressing, an indolent So an a is symptomatic, these it with they're the want aggressive into number tumor, -- or is that, disease, DLBCL like this. clinic. talked cancer. go it patient have them not the tumor now are if the But to they're physicians dealt go

to try the patients to see physicians and encourage come So in.

to able vaccination getting expect And is category to clinic to have as the vaccination to patients clinic. we an factor because the based the so to change be access they us into increase or increasing, come on And important hope coming the of COVID for access now that we are us what see therapy. for these it's these to the the patients

it's to by change environment very COVID think changes. we're I again, So And the going encouraged as that.

Mohit Bansal

you detailed of third-line for to been choose else the point not Very to this. prescribing something extent prescribing setting? by other or this are who TAZVERIK, question, very has helpful. especially Thank why you physicians much reasons physician in TAZVERIK One over what at the is

Vicki Vakiener

a say of is in over think not, surprising, typically not, question, great it or often that and hear looking community see a meet from we over in nice news -- COVID it we of and have and couple option. they advisory setting, The outlook especially lot And me. of is over I habit. or creatures good lot they is, is them there the physicians believe another And are again. at now to talking a We factors, do use That's you we believe -- which Mohit, it environment, they a Rituximab a to and and therapy Rob use, a we what it's right. great Yes, again. that's in and sessions

in like point prepared top-two right. counts; habit. for my so, And frequency our these I We've across all tiers. made right them message to about said, tier change takes we've getting physicians, frequency But the reached I takes that of multiple remarks, reached it it us just times over XX% top of

as from lot the mentioned we're it the because perspective, in get field for And a so in front things I challenging doing team. peer-to-peer them to of different ways of is

Some of these accounts are still closed.

get it's, the tools, doing said, providing that engagement, we're to educational use other And So peer-to-peer of I help they like they piece experience, wow, really is they what finding get we're the with the the novel things once again. them want label. are they drug to an like

So getting that is really experience important. first

Mohit Bansal

Very helpful. Thank much. you very

go Shefali. ahead, Sorry,

Shefali Agarwal

especially think it the is TAZVERIK don't drug TAZVERIK No, I'd choosing patients It's Mohit, I think an I getting that one chance other change for over don't in point go now, thing the some these more a right I back, they're situation moment. like this think at important want that therapy therapy. over over it using just TAZVERIK to -- to

in clinic, that therapy. for a think and the trying going just I change not they're to have

during to it's that situation. So remember important this

Operator

you. Thank

from next of Our David comes Lebowitz with the line question Morgan Stanley.

now open. Your line is

David Lebowitz

for my question. Yes, taking thank much very you

of running course until until can to the guess launch to into see, normalized? you the way need really with guess -- of to a get its Given the more the of do environment, a we the launch? I normalized wait as XXXX, nature closer current environment used I kind more in guys any there, you could is virtual Or launch get the pandemic we kind see runs getting that we

Rob Bazemore

for question. thank David, you the

and add I if couple I'll your question. ask to Vicki Let to anything. of There's start missed parts me

will the completely we point a First long pandemic how view taking that needs -- all the different taken pandemic for how -- does be return and respect will of market of don't to view. be with be we're I executing effective, of us here. it effects need to normal able know to the think we're to to and does somewhat the point the of We've

mechanism, do effective to. product, a So we're the adapting and new we're. finding have remotely But be even is in is And does to harder matter. new that that. environment everything a The we're you you're challenge the educating current frequency to working this when frequency doing more to way we're get ways on

patients setting, thinks not data TAZVERIK. use label in interesting product this of the It's the actually how helping physicians environment we're the in of to the change call. talked to waiting the about more really the on the front understand institutions quarter. we're help and how certainly the especially forward that some the differently to in that some it big didn't were and that used really And in who because coming community more to because effective we're We're because work trigger, to to go of Some of We're physicians things environment will in, when finding access I'm work of the haven't, very be change. will starting fourth institutions anyway. see normal, to the that's the with who've sure respect other starting effective it going peer-to-peer effectively But doing. big, limit and not learning in back us change, the for completely this that access done actually physicians we've to we

a take now These better These patients. watchful months, waiting of few are seeing go to them. months and the physicians that come cancer these one, upfront, the number might And just starting big the for many, rolled things, we two want can't to wave to a year. were physicians. a they seen being are their first be for to it but in back But vaccinations are two, and was saying, patients, more haven't We Shefali that, change vaccinations waiting the distributed. been next to told But see quarter with patients it the so this without they've long. although just out again, patients. that now expect really fully patients works of starting in as are to approach Number of ask these be because they many they

revenue the So just rate expected we we're it's giving year. for change to begin to seen change will year which that that happens to to ultimately will these for be by is the expect wider I do physicians. said that a need The is completely reason patients only reasons guidance that that We unclear. this start vaccination the and not their it fact

Vicki Vakiener

for use opportunity is it's we're there's of hard controlling on although kind I control. like educating that new to experience, patient focus to experience, We we focused to getting, we that the directly with work on they one place to would But David. experience the once based to are accounts on, get advocacy see which can't impact control more. that, why -- necessarily doing we what there with on was add help that to an if need control, can focus getting some we and back drug. us coming just going that. what I in we Yes, physician, have That we with patients we're getting new said, starts believe And and can

control on this we're point. can what at focused we that's what So

David Lebowitz

to that to to doctors subsequent in the like before mean their change that a I come if be that see therapy, in order relatively in might typically like guess has point, typically point see to also comes patients they to of to a subsequent they a patients patient issue, doesn't level physician, That making at makes comfort the able would sense. When will short the the it a patient tolerability that that. given need knowing

they subsequent patient need able they coming the patient in -- just need they'll that they months? to but the be see to the know initially, don't So to to see

Shefali Agarwal

is this Shefali. Yes,

address me Let it.

feel hearing symptomatic progression, something. patient new especially in initially absolutely follow-up what televisits, that symptomatic are is very think do I'm that initial drugs. they I receiving no their progression to of is televisits, safety physicians, patient the is that there they they scan happening the that frequent progressing. discuss know, have happens low, But is they have think there is concern come And changing they right. ask TAZVERIK they therapy and of and absolutely, is from in, into that and you issues, And to So knowing profile if that that if the the the they the as if I ensure they're if is the scans,

safety and don't and that's you of has profile giving the therapy you that like monitoring TAZVERIK we I monitoring So but TAZVERIK, strength where and is monitoring, IV kind of require an business you're IV or something that, important think -- an feel require if requires administration, the course of that's less that's monitoring.

Rob Bazemore

a of was It part the answer.

Shefali Agarwal

your that answer Does question?

Rob Bazemore

question of And have use. patients be situation, come what mechanism If a physicians, patients. try open a very a more new it to something new, don't much tried great they from they David understand. that don't the of they've have part to they're seeing what actually is even too or referenced in this many with. experience you that They're more was is patients in they profile, once they're the hearing ideal drug was with has reluctant a once prescription to writing don't patient, if responses it; the drug opportunity. we're may more because the barrier and part in well seeing seeing have tolerated. not what's But in earlier Yes, their their initially, the they're It's to to they a that should drug that is, you be

written have So, surrogate now who've well. the in using experience, comfort their as doing opportunity getting as the a that really peers in directly to them because and effective they're TAZVERIK own for Vicki programs, first drug, it peer-to-peer give so their we're from been despite to takes just as said, patients hear

Operator

you. Thank

question Lawson Barclays. line next of Peter the from comes with Our

Your line is now open.

Peter Lawson

for taking questions. thanks Hey, my

Just seen? last you've renews that the sense of dialogues, a any follow-up from script

Rob Bazemore

the are that of channel, And to I'll channel, specialty maybe visibility sell the from some have expected response in Yes, clinical ask to let have persistence the drug. setting. for specialty was scripts But further. those me the II distributor on pharmacy more start them to FL a And the and Peter. far what go great those that. we distribute seeing to duration And as they for through But, that the would don't year the higher patients, of expected actually comment so patients. for prescriptions, lot of then with our we we response duration the a might Vicki study Phase have we accounts. in we go be refilled Remember, we the to see average can the we're about channel

been the way in to that therapy. So we've the a got are written on approval who've we patients actually all back majority FL still when of June, seen going the

very regards Again, are seen compliance, pleased with as we're very the their we've in there compliant II to patients of by with not trial, rate compliance that. with just high therapy. any So a Also, very issues we well. saw compliance; Phase

rate Phase severity duration the higher those patients treatment disease. who to is to a are of I didn't patients earlier patients average those patients of upstream, of compliance who first-line a expect are we focus in we the the patients second, in we and saw shorter higher of our to off study. getting the this push dropped setting issues. about really have said, year In some That's tend in after, third, ES Vicki that the response got much more drug their on why beginning where survival a think but II fourth So the sarcoma, were epithelioid an And the as first remember, because those months launch line. five have

Peter Lawson

just, out that you. moment? of at there is that scripts then kind any of -- or Great, thank versus the way to revenues breaking XX:XX ES And follicular kind is like

Rob Bazemore

much pharmacy saw I lymphoma. channel the follicular the the the the that that our Because visibility talked in view less ES. of and that how can growth I But the way came fourth specialty of factors through the them go that quarter channel, from is we have scripts, you distributor into the with specialty we tell majority the about, of all

Peter Lawson

and kind have seeing Okay, an you the and traction first for of thank tazemetostat NCCN you. question And final the seen a the started then from on change? impact you similar or just guideline just XQ, weeks trend a of last, few

Rob Bazemore

Let separately. this address me

first guidelines, think it's has because the the the NCCN up. I time come question

First allowed of all, the label that. already for

So the NCCN guideline isn't new.

it's requirement in for comments provides they flexibility the some physicians the confusion appreciate lack them. one about reinforces the for TAZVERIK, it label use if might that the of physicians, think the good had the testing that have label label. really for But I of already has and allows for the some for us that been they who

guidelines So before. not just we the quarter, that, NCCN the think didn't the something reinforces it's are with trends actually new positive. that But regard first exist to

specific giving in. to end the But but it XXXX. not to kind expected around continue take in began adoption, of We've expect first would we're we saw quarter, that patients we on said, hold guidance I seen to we the more. respect coming coming vaccinations trend be we after with of physician see of of out the not trends didn't major quarter, larger to, but a first some difference As

Operator

you. Thank

line the Wedbush question of with Our from Nierengarten David comes next Securities.

is line Your now open.

David Nierengarten

Thanks the for question. taking

right, see the might to, I that it go was what physician times we looking COVID doctor So going pre-COVID, about that appreciate see there an of in a patients or visits. pre-COVID knew to that going could recedes, to or of Thanks. to back in go to a opinion, or that these the think forward? many question would was? my your be the kind about knowing is see And rush frequency, whatever that reset patients the the get of as their therapy again, so their maybe with you frequency doctors appointment Are same bit if frequency doctor how

Rob Bazemore

Yes, David, Rob. this is

answer. me So parts. let two are There

would about often Shefali changed to and patients I'll talk cycle with over a talk how about of Let to see their tend turn I'll it are me the these then getting what physicians. patients frequency treatments regular be which to normal

tends often they of The therapy later just been I'll based year, year, approved in see a setting, data of see because about once third-line average, third-line physician we speak typically their to actually of year. we the based drugs a patients let With on to expected, on trends other respect how have about the on to their duration the response treatment, in course historical be duration and that. and turn the to over Shefali that they that

Shefali Agarwal

David. hi, Yes,

number months the drugs insurance we and highly third normally they So therapy, go on every visit that. the at just of given to line look and for scans the do, it if IV a like for patient, certain you like on initially beyond, three issue, and depends go the and you also the safety patient, coverage given for administration. there's that the IV, that of would it's they to Unless check year, doctor give ideally they line based it's and every example, RX, it's to scans it's and they -- high, are given an I'll it's -- have a things

getting you're three every But things months. So you a check-up, go more like normally, and for normal frequently, that. because it's IV

David Nierengarten

gradually, bullish, a be think a there it increase do whatever want it patient say will receding in in don't blip or just regular that kind because And kind temporary those to or you sometime? gradually recedes you think think of temporary returns it. to it's will May, it Got perception but it call like I of you a as said, visits want to I do recede or you obviously

Shefali Agarwal

everybody's still they're to one on, vaccination think depends covered. I to the I them I how all so the But patient trying think overall, they're that, COVID lot the that would to frequently, So at patient, I I come get don't and expect talking depends all believe go. physicians, as how it in, on talked

right. themselves like everybody I It's will gradually, just will think it open hospitals the vaccinated the to gets normal away. going not be and hospital become right and happen, gradual,

time I to think it's going take to adapt normal. to

what. that's I think

Operator

you. Thank

comes the line Andrew question Berens next from with Leerink. Our of SVB

is open. line Your now

Andrew Berens

the going mentioned Rob in thanks, predominantly is get to second-line prepared you the uptake patients. EZHX uptake an comments, setting. in think Hi, that I your But positive you're

lymphoma, have on the guess, part promote is you with this, are few observation. going And you amongst So of tested positive? being Does follicular testing a now patients what patients I docs? of percentage that treated I to may status TAZVERIK said standalone have questions and EZH a the have testing EZHX EZHX then seen as for for but what up? encourage And versus panel? awareness you that test, And of of a the wild-type number status

Rob Bazemore

are a So there lot parts that of of question.

anything, in. walk Let I Vicki fill one-by-one. And me the questions. let through if I'll for Thanks them missed

to testing, I think around question EZHX all, talk because your about First let's second-line. it's of relevant

to We able decision but understand we test, times patients, from we about expected increase hit use as have physicians they an the like same a time TAZVERIK type that is levels. following their of EZHX or testing the they of looks the research a market want many the at be in pre-launch expectations up today; seen necessarily for it about they're What prescription. to they're write EZHX and testing not. just disease whether ordering their it's the testing point from understand we we are do, patient for to would as approval. not with They that the bit that From XX% want has to set

combinations been physicians as commercially actually of monotherapy. interesting TAZVERIK. So is a because that's has condition with used so been we've the second-line what monotherapy, it are they're the label, as experimenting a most the In using and combinations, of the that seen expressing think I far, it has setting, lot more for different way most use TAZVERIK prescribing probably of not for

monotherapy where in the again second-line wild-type, stronger the to of coming data a setting, that's more the in setting. it sense second-line as versus be mutant in So use would the given makes

two questions your answer that those? did on So

Andrew Berens

Right, okay.

TAZVERIK tested the that XX% of are --? EZHX? Or So, about get seeing is you the patients XX% for

Rob Bazemore

reached, the XX% they that XX% about patient for of XX% with did not market testing. are testing said we've about say the physicians now of EZHX research necessarily Yes, of -- they're physicians

Andrew Berens

Okay.

Vicki Vakiener

not. number -- at quite or whether that tested we by were at they that do include is obviously claims data but Getting doesn't claims the getting challenging because data

we as the have. well number in market more seeing research utilization based have setting, good mutant on test we the we that know although that to that we're So don't visibility third-line

Andrew Berens

Okay. Then percentage what --?

Vicki Vakiener

The or share in is than wild-type. higher unknown untested or the

Andrew Berens

Okay.

you So I number just available? think drug have follicular as in are percentage a follow-up, EZHX the that patients would that of what positive, that get

Rob Bazemore

We of go the don't which the through scripts have a of good breakdown distributors. specialty is on that, again, the half because of the all, over product, part

So those how through is have is wild-type, we of And specialty to get growing. actually we're said, But are of the than used of getting feedback, getting a new things, mutant, the we of growing, physicians research distributor. XX% not do and research, to being test prescriptions at captured retrospective quarter. in big higher Vicki patients pretty the on an understanding anecdotally part all, think setting a three the are the that, through three of actually to all we're exited market average the that's roughly the third-line the in both as all of average drug which where XX% the untested, don't all for market it's in quarter over

it's were new pretty more wild-type it’s quarter terms total. a patient third it's and the who untested, of is the we mutant, were where that's large double those, across But starts. in than of in which group patients So

Andrew Berens

standalone a as test EZHX test? the of availability the is What

Rob Bazemore

local label FDA EZHX is we're what the for also any sufficient. pretty And for test from hearing is the available. allow widely It's that approved, payers testing. FDA allows for Remember, they

own their there and on Quest they included diagnostics, Also, that both So EZHX other in include that with panels there them. many use. EZHX panels institutions are are tests have commercial is can

So around are rate physicians there today. think many testing EZHX among up XX% that's pre-launch gone up from reason a that ways We can physicians testing. gone XX%, to of has the XX% part that access has

Andrew Berens

Appreciate for it. Okay. Thanks the all questions. answering

Rob Bazemore

Thank you, Andy.

Operator

for turn back to There further Rob now would remarks. you. Thank no I to call are Bazemore the closing like questions.

Rob Bazemore

that healthy. Thank March join thank stay Epizyme next and discuss hope all on for and We Tuesday, great to you next you, operator, a all and questions. for everyone. of safe all and the joining our for you call today us day. us your Xnd you for Bye can episode Have

Operator

your today's and Ladies Thank concludes participation. this for conference you gentlemen, call.

may You disconnect. now

Epizyme (EPZM) 23 Feb 212020 Q4 Earnings call transcript