- Earnings call transcript Q3 2022

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Operator

Good morning, and welcome to ImmunoGen's Third Quarter 2022 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Anabel Chan, Head of Investor Relations. Please go ahead.

Anabel Chan

Good morning, and thank you for joining today's call. a operating that XXXX progress issued of a financial we recent our and today, press includes release summary results. Earlier third quarter an be release, corporate our and website press a of of call This immunogen.com. recording Media section deck under found and can at the Investors this updated our are Anna and Berkenblit, Susan our me today President and CFO. With Chief Altschuller, Mark Enyedy, CEO; Medical Officer;

business, we will upcoming review our the QX call, for highlight financial today's During anticipated accomplishments events. and results recent

XX-K our on uncertainties, based expectations statements results forward-looking press making be this In other subject Mark. report the in that, and and will XX-Q and These the immunogen.com. filings, release sec.gov beliefs. risks may call SEC Form over quarterly consult to recent morning. are our and Factors Risk current statements of Form outlined Please We and actual our on our in section are turn the With most risks issued differ and to materially. our available which I'll at on annual report

Mark Enyedy

and this you complete XX expected November us or joining taken on thank launch for today. our approval date, to mirvetuximab last preparations With quarter before our we've the to month. PDUFA morning, Good

these activities, is to put a with highly finer point staffed experienced field Just team and our on fully customers. engaging out

place, drug deliver in Our commercial-ready foundation approval. inventory and product packaging. mirv patient we infrastructure support this to access labeling strong have distribution, awaiting ready and upon market vials are is in of to patients With and and we place rapidly

on of our which we our cancer of updated data external market a draws preparations, part from As couple ovarian sources. recently model, have

adoption At XXX physicians roughly United focusing highly over as initial of concentrated, patients. just cancer of X/X on we to a be priority physicians an First, this taking States. will that patients drive XX% subset of approach treating targeted in is a roughly by ovarian with X,XXX the launch, market treat

population ovarian line patient year. XX,XXX data DRG, the the opportunity, fourth estimate each in from there market patients Looking to is Roughly FR our which platinum-resistant alpha, based receive indicate cancer of eligible to the patients XX% are second U.S. us of anticipated that on non-bevacizumab roughly initial XX% levels or regimens. single-agent to express market high a currently gives label. for This of X,XXX patients XX% of opportunity these and our drug-treatable chemotherapy

We will in total would immediately a after listing add combination high the X,XXX alpha seek also setting. X,XXX of FR NCCN compendium the approval, opportunity mirv-bev which another patients, patients giving platinum-resistant for us market

website would our to call, on market above we to into corporate slide We've As we recurrent move will recurrent in studies platinum-sensitive as posted an included our market patients. XX,XXX initiated have for disease, total later in deck U.S. cancer the also ovarian of discuss opportunity which bring mirv part updated the today.

to we topic and the expect approval sharing year of next in On confirmatory early development, data those line regulatory EU. filings report look to full and as the we top from data trial initial the U.S. in pursue the ongoing MIRASOL forward

have activated and our first studies the and XXX populations the Gloriosa are patients. trial these move mirv address efforts advancing in into We sites also to platinum-sensitive both to

more Moving or efficacy-evaluable disease novo in the that update malignancy, those CADENZA BPDCN. and align patients. a with showing initial important presented this an But hematologic significant will pivotal be August, study analysis activity novo concomitant short, to prior program, who detail our we an will patients in we with following pivek our in on Anna in frontline study. provide with shared in de population de FDA on

presentation presenting be note, and in initial in expansion our for mirv data I ASH will AML pivek will programs consecutive December. in ASH. the we be we pivek report result, moment. both to just a XXXX. at cohort a in will at oral pivek now cover This expect of As from line data Anna top Also the triplet fourth

rest our co-development Phase I made on the first-in-class additional MacroGenics. to anticipate and put With over dose development our patient the targeting Anna? data we I of turn meaningful IMGNXXX our ADAMX, ADC Looking study the I'll IMGCXXX, that, at of also the with sharing the the on before to end expect Anna study pipeline, progress first We've initial before and of call of from to programs. provide year. on the escalation color year-end Phase

Anna Berkenblit

Mark. Thanks,

XX. As be PDUFA mirv's we accelerated we date, or confident upcoming with will November are that noted, on before granted approval

SORAYA particular, patients and with the Given in pivotal of believe positive, chemotherapy of single-agent folate data ovarian as totality a mirv potential to standard for the strength alpha we receptor displace cancer. of the platinum-resistant data, care the generated, new the has

the and I data, Beyond U.S., trial the choice FDA patients with in position efforts, at to additional presented I broader single-arm ovarian continues platinum-sensitive in from data response cancer, label, extended patient-reported the ovarian advance full for expansion of monotherapy upon agent study exposure treatment our presented population Reflecting and these mirv in recurrent, cancer. Phase patients ovarian the as generate Building ESMO folate we studies, alpha ESGO, FORWARD in we program I of in support we in monotherapy high, data initial mirv continuing earlier mirv these towards are may enroll additional week, we as from from to approval PICCOLO, including pharmacokinetic at outcomes FORWARD receptor lines and recurrent XXXX. benefit of studies which these September. and label work SORAYA, mirv Last characterizing treatment for our cancer. the analysis in combination

presented advancing this cancer. demonstrated ongoing expression we in which a study, significant bevacizumab setting doublets plus plus randomized initiated. the the studies. and was plus regimen At to III mirvetuximab that ovarian broad bevacizumab across forward mirvetuximab Turning carboplatin bev-naive regardless data in were mirvetuximab IGCS, and maintenance patients to range combination activity receptor the receptor Phase of encouraging the bev for the folate alpha-positive We folate alpha recently interval. platinum-sensitive of our X GLORIOSA levels look or platinum in in combination both pretreated Notably,

FDA, recent progress are the of Phase pivekimab In with patients were the CR/CRc of prior of concomitant pleased encouraged secondary key in ongoing an in seen trial patients, our or as primary and endpoint patients with XX with a the malignancy, XX with pivek. the will initial study. that We roughly response. the CR/CRc XX% very second pivotal of in BPDCN form analysis de the achieving for we or with program, of BPDCN CADENZA and with efficacy aligned patients, discussion evaluable In primary frontline endpoint data our be from or population novo activity the complete de BPDCN both we as duration of novo a hematologic patients

addition, In assessing enroll PCHM BPDCN support further patients to encouraged explore CADENZA to in to with an data us CRh as point. end potential generate continue pivek also benefit FDA in Accordingly, population. of the will to we this

frontline Susan? over our Turning and azacitidine December, The SOHO from in And to at broad our with the cohorts present we session. an in the to I'll presented with relapsed in call in initial financials. of expansion data that, And activity demonstrated venetoclax turn and triplet oral pivek unfit at adverse to AML September data relapsed-refractory subsets ASH will Susan AML. disease. genetic in cover

Susan Altschuller

Thanks, Anna.

royalty cash $X milestone of million million XXXX, and comprised quarter third $XX.X third from which in ended we of generated quarter of noncash the million sheet. revenue, million license Operating expenses $XX.X in the expenses, revenues general million, from were we $XXX.X the selling, fees. $XX.X R&D administrative with $XX.X of came balance For remainder and on and of million expenses, and the

Our million potential and guidance between attributable financial reflect preparation the does mirv at and million million and grow product $XXX clinical expect $XXX anticipate million. execution. at expenses million, not to has in and is hiring, cash Revenue for expense cash to and The revenues equivalents sales. $XXX that updated, expenses $XX million. the between and a operating quarter. and guidance faster-than-expected guidance $XX we third trial in between Operating XXXX year-end any been quarter, to strong $XXX fourth now and We relative largely in but pace operating to commercialization moderated seen start-up for be increase

collaboration current call XXXX. for With with the we'll and our fund that open will questions. operations cash, that, combined into expect anticipated product We revenues,

Operator

Instructions]. [Operator

Our first Canaccord Newman comes with Genuity. from question John

John Newman

if the curious, patient regarding for think you that top in curious tool Just endpoint to survival, outcomes are some reported using? PFS also line bit talk you the endpoints, addition but data the able just that a secondary XXXX, to early including overall MIRASOL about be you I'm in might

Anna Berkenblit

data on also have point, the survival. have in data on so line survival. the will key one And for will That's MIRASOL, John, we top information endpoints. DOR. the that ORR endpoint at We'll or report time XXXX, have data interim immature Sure. secondary we on which is progression-free we primary at of overall early and

subsequently. detail I early sharing little meeting, will patient-reported coming anticipate to as having and a outcomes forward data, reported and time major of think sort to a we outcomes top I look that data that's be possible as And PRO line bit at It in a analyze of data. data. early second takes would be to in more wave that the too would medical patient-reported anticipate

Operator

have with Partners. We a Michael Schmidt from question Guggenheim

Michael Schmidt

thinking how test of you like on relative topic? a the your Mark, increased the could used initial assumptions wondering, the mistaken, testing sort opportunity. play slightly, for dynamics, ovarian any if sounds Just you your prior of you're think may is And talk adoption I'm tests thoughts of patient initial that to the cancer? bit out? the how in that about launch you about from with It on other that widely you sort of not BRCA Could target perhaps like, estimates trajectory test, share sort

Mark Enyedy

Sure.

just maybe So the with starting numbers.

that the don't with generating or get we opportunity. combinations principal shared prior an our in the that the population to the net internal adoption. that which fourth EpiData platinum-resistant Health, that and indication out conjunction elevation particularly the our terms line overall vendors, ovarian things and population. are DRG, in those up saw Also, then numbers, in of in bev-combo And and distribution single-agent of in was IQVIA of forecast, better understand and forecast between the our single-agent regimens second the we chemotherapy to initial So turning went to market then we launch And of of a that use launch slight patients then treated. our non-bev drove segments effect cancer or these increased. what updated also use Kantar bevacizumab that sort And the principal terms was the of to our include of from preparations, data numbers in chemotherapy prior

So obviously, status. identify the alpha the first FR patient's to step here is

step testing Roche. with so important in is working the been And We've first that.

upon samples accept have We to approval. up are and X and running that ready

the are going transmitted to to we these probably labs, the to those to treating they're and and from X-day So turnaround tissue also tend patient's talked to patient Right the physician. be turnaround. for FR alpha weeks, for a now, time biopsies, comes although even then We've scheduling back estimate actually allowing archival the for the be both time which about fresh determined centralized is the time are of test infusion. to status in dosed a rare, sent, X- or couple a then that's an that, and is

So asking us last send over FR year. of they us seen are can or samples. look, their who significantly we where We've the physicians now increase have alpha awareness telling now

or with major monotherapy additional are combination. We mirv in data, all at congresses either out the of

so the in is And commensurately rising awareness target. interest the with of product

things good we We've that sets terms got now and ordering in the feel like about launch. right they field accounts where we the profiling of the so the very the understand are in like. folks can So

are So the good shape I think in we're very prospects. and excited about

ways away we from the revenue where think early given you offering specific today. stages any I we're guidance of product actually are

Operator

from comes BMO. Etzer question with next Darout our And

Etzer Darout

Great.

for And your wondered any of you conversations with initiated. in if just them? the the just FDA looks labeling maybe sort IMGNXXX, negotiation approval? had if generally you secondly, could then, I was with us Just current for Phase remind like sort of And just quickly, where mirv-accelerated discussions are you

remind sort or plan just relative where of this position us you could to asset to you mirvetuximab? If how

Mark Enyedy

Sure.

and form positive terms In in conversations approval highly on agency. of been before productive, have we've both FDA, an been date. we engaged those PDUFA the confident are or The of actively with the and and substance

the comment can't as I to say, really than we product we're that, to said to Beyond launch just Michael, month. other this ready

alpha activity expression. of is XXX, at you'll antibody, levels to FR lower molecule terms a towards so the and all of which of designed that's the been In with remember the driving linker specifically payload, this are improvements

So And less positioning monotherapy, is see, and mediums expression certainly to as market initial with been those are levels low the outside of to certainly in FR indications segments, triple-negative here the mirv XXX. active, the with of really at alpha breast get setting, patients a in like expression. addition the characterized cancer, levels where preclinical we one, twofold: are where has of ovarian lower significant cancer then activity where that, generally moving with

how that's before first expect site XXX, put initiated our thinking the the patient it. our so and We've on end the And to of year. we're about first with

Operator

Our next Boris from is question coming with Cowen. Peaker

Boris Peaker

discussion reach study. is confirmatory does MIRASOL study statistical first if with My question points? Can your the on FDA that case GLORIOSA potentially comment over the trial not being end you on its in

Anna Berkenblit

in about plus of we the platinum-sensitive study, of We're really address setting aligned in FDA here. with Boris, FDA the initiated is getting be so compared that alone. study. maintenance we specifically disease to we excited bevacizumab with mirv It's on design study When randomized which GLORIOSA, it for recurrent that the of on a III did a the going not Phase potential we're confirmatory bev with study. design and aligned

chance appropriate certainly, needed. absolutely to the a confirmatory it expect turn on the way out does back, it's not if study, stepping MIRASOL we that GLORIOSA as that However, to, think serve could off

Boris Peaker

asked labeling the what Great. the around vision part on your label Avastin of warning for you of are your have being Is And Box label potentially thoughts Black that? maybe pretreatment tox? what been terms Kind discussion, or in of of that discussion? requirements in kind

Anna Berkenblit

Mark mentioned, of we I what the collaborative pleased label. point of tenor is with And we've conversations. label and this productive tell as at that FDA the look negotiations. the final you details forward discussions tone to So we're had sharing during the and with And can

Operator

comes question with from next Blair. William Hsieh Our Andy

Andy Hsieh

focus the just one team. on what commercial similar asked previously, Maybe Boris with Great. of to kind but

aligned in, label the with label or maybe So there's that's we with approval, assume obviously, going aligned that's more if more -- outcomes, two there's SORAYA MIRASOL.

populations, PDUFA So to Avastin agnostic I'm X head date? we the would these kind populations, how the the just of be team into much Avastin commercial terms responsible in of communicate the of curious, or as messaging experienced difference

Mark Enyedy

the So team about product the commercial is now. right not talking

are drug thing, accounts, they of So at this in of patterns, point. there's ordering patient flow, that discussion the the but understanding kind no

Avastin, fourth patient experience, of -- no the use think sort there's profile, thing. is half of line FORWARD from and of population prior flow, drug imagine But, of outputs on will had the to As based on them then I bev that's And could call part per just the that be the you other setting. have the we discussion again, talking half asking will about prior second we platinum-resistant based what in naive of that se. prior our roughly and bev, had we this it,

question, So answer your does Andy? that

Andy Hsieh

I then And Great. a Exactly. Yes. Yes. have on follow-up Yes. pivek.

history of I look worthwhile view for that curious in the or to has pathway FDA AML? a potential talk future? you just the about the if can if a you if the that's molecular of yesterday, kind markers. becoming panel So don't let And the in know mutation a have data expedited know I'm within standard a place us within so, very provocative. whether to submarket FLTX-ITD it's if think And planning it's is taken discussion I that given obviously, exercise to

Anna Berkenblit

Andy. Thanks,

our data and relapsed/refractory as we FLTX-ITD. we had venetoclax triplet at particularly patients patients and the triplet forward including data oral a see in abstract. And of what you're really XX well patients look is to subsets, very our to AML, for overall, with ASH. certain presentation in azacitidine plus So where our as ven-naive referring with encouraging for pivek We

FLTX know, approved, FLTX also with there you AML with patients As are well VEN-AZA. quite that are with and inhibitors mutations do

CR a that niche so And and on option strategy. the that's excited our that's I certainly XX%. we rate overall the think specifically, it's development activity with we're are seeing think And very table XX% certainly the rate say seeing, one that choose of if for considering of further to fair very the response for investigators the I we're

Operator

will Our come next Courtney question Kowalski Barclays. with from

Peter Lawson

This is Lawson Courtney. in Peter for

for of the if up us of an expected trained and you test kind increasing and FR the just the labs signed give that time? over can test testing turnaround and on have Just for kind you idea how time, alpha, for potentially turnaround many kind how of of see

Mark Enyedy

Sure.

Right been labs our We X right X that the now, of to there turnaround. expectation terms in So now have is them certified. call trop labs. are X days

we So validate those to worked labs. Ventana with

do ULTRA, over a in to ready machine expect on vast BenchMark institutions. called they're large Ventana test So a is the run samples. -- so is time, installed of this majority We receive which a

that be So in-house running the test to centralized we do those labs. out start trained institutions samples as expect on over test then time and the to opposed sending will the the

Peter Lawson

Got you you. do labs you -- what's reach with labs? Just And up? then just how existing need do X more the your signed

Mark Enyedy

labs capacity. country The significant cover will have existing entire the and X

if run patient capacity. all terms you this their every X,XXX of think they in Just about population, could year patients

here. So not getting samples just logistics laboratories. constraint is It's capacity them the of to a accessing the and

Peter Lawson

your kind just And know then the if you. departure new CCO, find just of replacement? talk this a of depth spoken team, of uncertainty about before, you if that a through the but I amid causes Got any potential we've And the launch?

Mark Enyedy

Sure.

we'd is here timing And make I points the X obviously, guess here. unfortunate. So

our going first that to to this home. a was Kristen that The allow be personal closer was decision

the this business. is, is to second unrelated The

and before PDUFA great date. she's her us on And this, leaving are for and shape. thank We approval highly confident lastly, we an in the importantly, in or

into pleased marketing. at a He's than Talarico bag. XX professional. experience This We're have interim bench. deep of role. stepped is the worked He's the on years someone Access He's So more carried just we in consummate Market industry. have to recruited the with a Todd

So into the and role all is breadth stepped that and of the he's functions, got a the experience with of team happy commercial and covers him. depth he critical very

when we again, of look and somebody Crawford, in with an in deep malignancies, this the construct that, years field role, solid ADC, Nicole experience the starting last Beyond a with heme like in industry, at is at radiopharmaceutical, with XX-plus experience familiar product tumors top marketing. force so strong selling, her the

from when we've a So many oncology premier got industry. the field the the the we diversity and breadth depth drawn of look we've of at franchises around force

so a thing, ready by not this this And go. of experienced of from to a product rattled sales you when think, by got to base, this at site. are And So driven in very we're energized. team when training you're enthusiasm of customer walk you know X kind halls is seeing and people ago, around weeks the and meeting ImmunoGen, our that went is right? people you've want, And I I part that the Tampa

an it's -- is this moment. think exciting I so And

the I to As we're said, but respect timing is with ready. Kristen unfortunate,

Operator

question have from Shi Jefferies. Kelly from We a

Kelly Shi

kind the would manage could you all, challenges solid data? will with launch to tox? be wondering, of value tumor enough first-in-human heard present of in First also, ADAMX, choose what next I'm you the preparation, guide pursue And types at ADC, the logistic what ocular any secondly, have you And to stage? to ophthalmologists coordinate informative data during to the

Anna Berkenblit

Yes.

study our the Phase I, we to our the of that is from dose-escalation year. ADAMX-targeted sharing end we data ADC are forward before co-development in with MacroGenics. first-in-human, IMGCXXX And look So

in further I folks terms there of dose type, tumor schedule. understand development data thoughts those and for think the will help

before of forward So end look to we year. the sharing the that

Mark Enyedy

with trial. of fortunate consult, with have our Yes. terms ophthalmologist so clinical conjunction number centers of in And worked already we're in a to

of So target many relationships we've our those got centers. in exist that

come we're with first events. that, ocular the not to Beyond ADC

the with are exams in in what questions are And so referral of is ocular messaging we've don't terms exist to those managing that finding with events one administration And help accounts, in the therapy. how relationships relationships can the up to is, together get also in set as key conjunction we you to a respect put standard being doctor running. support then arise may of a with set that those that that again, the asked event profiling conjunction of are up that, therapy? and And we're they -- eye up

Anna Berkenblit

but community not which can And I one just ophthalmologists, be the helpful just in add exams settings. would that is done is it's eye by optometrists, thing

Operator

with We a have Wainright. He H.C. from question Arthur

Arthur He

my the on mirv? though, This on based XXX, have one questions RK. just threshold Arthur I what's how to the for had remind Phase And been I patient of is large study? compared population on And us addressable asked. could the for alpha FR Most you the that, for the the of inclusion expression

Anna Berkenblit

sure. Yes,

is expressed cancer. XX%, in of alpha FR So ovarian XX%

almost like that's cancers. all So ovarian

we're And we study, so in cancer on everyone. tissue our tumor ovarian all XXX and collecting patients, enrolling first-in-human are

study. does FR really patients, So those and With alpha not us this again, our at cancer, impact high-grade to just I endometrial XXX CRs lives subset have cancer exploring the for type, exciting and lower the the alpha FR is potential that particularly in all an improve but is with that expression, for expression. the tumor type of ovarian has mirv, levels other high Phase really to also for then be

Operator

Our JPMorgan. comes Wolle Daniel question from next with

Daniel Wolle

of previously, had about mentioned as of exciting Anna, in setting XX% AML. the you relapsed/refractory rate

the be how the presented data at for With of complete we to XX% that's about pivek triplet, composite the ASH think ASH? going a remission should for abstract showing

Anna Berkenblit

Yes.

becoming So we standard as are. treatment our frontline is And of it's of understand the triplet to paradigm clear the because evolution interesting need care the really VEN-AZA AML development in is the who really and increasingly relapsed/refractory in patients that unfolding is setting. ongoing

triplet. good that would AML area should the of for I understanding point most in where really good as so benchmark patient at patients guide time That more that who set what oral abstract, very and us I'd an can the expect are, as well see thinking, understand enough to the for for we say, our really this data not the even for see robust this in that a to have the ASH is the the of will okay, is you at their presentation on from population So we patients bar us in relapsed patients enough who patients finger who are our out but XX% scrutiny initial intense say, we in benefit activity. in XX wind setting details therapy. is, these most

feedback where external that's we're our as So advisers. internally from getting focusing as work well

for stay ASH. So tuned

Operator

question our with Chang from Jonathan comes SVB Securities. last And

Faisal Khurshid

Khurshid Faisal on Jonathan. for

Just also the you'll to in data ask abstract wanted wanted to data ask presenting AML? about path I pivek I And the like looked forward was confirm relapsed/refractory, as to want as the pivek coming it just well. be up. frontline what you see for

Anna Berkenblit

Thanks the do will question. having enough oral was -- that frontline abstract, abstract at We early have in given We required the cutoff for the inclusion submission. date quite the presentation. data anticipate for didn't we for have

So been yes, in patient have also should should received small the who triplet, when have anticipate you but not we terms as out have others regimen. an myelosuppressive anticipate data that meaningful that patients agent adding seeing, toxicity the I knowing than seeing already stumbled would abstract more that I VEN-AZA just of say, is a third point frontline you would our also developing relapsed/refractory of a AML triplet. in group to

XX-day I with really prudence, of regimen not exploring We say, but caution, have venetoclax. with proceeded, would a

further triplet, And registration strategy. development and up activity of that the ven explore is the setting to would data to the guide we've we frontline the dosing as really think important the so of now the labels allowing about duration XX days, in further us gathered which increasing is

Operator

to the queue. like the closing no management to I'd in other And remarks. questions there call for are any turn back

Mark Enyedy

within Look, about an with made a talk and is very Great. much exciting Thank for and progress approval over tremendous this you this moment to we all are have the looking for year, forward us. We've course month, weekend. you. reconnecting Thanks, an of the mirvetuximab. of great

Operator

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

now You may disconnect.

Immunogen (IMGN) 4 Nov 222022 Q3 Earnings call transcript