IMGN - Earnings call 3 2023

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Operator

Good morning, ladies and gentlemen, and welcome to ImmunoGen's Third Quarter 2023 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 financial progress issued of a results. we recent our and today, press includes release summary Earlier third quarter updated section of This call website at found recording a our the corporate an under Media press be deck & of Investors immunogen.com. can release, and this

CEO; our Medical Michael me EVP Vasconcelles, With and of are CFO. Affairs; our Kalofonos, Research, Enyedy, Mark Isabel today and and our White, Lauren Chief President Development our and Commercial Officer;

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

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

Mark Enyedy

the productive Anabel. for us today. ELAHERE the progress made another for and expansion morning, ImmunoGen, geographic everyone, label joining launch portfolio. Thanks, has advancement of for been and highlighted in and you This the execution the U.S., Good thank ongoing of by commercial ELAHERE exemplary quarter for towards our both

broader with in combination driven and bevacizumab. product patient in our population successful labeled one with well of strong net factors, puts community broad a in delivered alpha which in million and most of oncology in guidelines, testing need and of quarter uptake sales, track population medical breadth revenue priority penetration across including for launches use robust adoption $XXX is We achievement ELAHERE as over million monotherapy and based on ordering settings increased the ELAHERE by just experiences. in in with our awareness accounts update. commercial and combination by discretionary us a of by affairs driven the strong the a high with patient with with including NCCN resulting part in over Rapid This positive by reimbursement physician as and indication generating both in data Starting decade. of on FR $XXX a in team corresponding of ELAHERE and engagement MIRASOL of use a compelling access unmet year-to-date, and into depth academic lines later driven increased prescribing, performance

a a say forward, continued we by and with albeit alpha-positive to the expect medicine our respect focus moment. growth, execution strong current launch at to have will about Isabel disease. Looking continued more for and base, future imperatives, our ELAHERE FR becoming prescriber moderating a on of and choice growing in pace patients supported with business

approval the to aim has patients application European and that look of China. we acceptance for our expand this we the share globally, ELAHERE NDA accepted As are to the geographic to support ADC received to to and EMA marketing in Huadong pleased novel our partner bring of potential footprint

conversion approval addition, here in of ELAHERE a FDA the with commercialize submitted develop supplemental announced collaboration approval and support BLA to to full to In ELAHERE we Takeda Japan and the to the a in of U.S. accelerated

ELAHERE to patient context, disease cancer monotherapy ovarian are In are combination in platinum-sensitive this agent expansion platinum-sensitive we trial advancing support efforts, development and into that as broader in cancer. commercial our with program of ovarian low we position II the ELAHERE has to to Phase the share our pleased ELAHERE choice step PICCOLO In in evaluating population. no will these platinum-sensitive detail of Noting ELAHERE, observed to towards data new are patients in setting, represent and Mike data the important to continuing PICCOLO endpoint primary that date, discuss These response this rate. and an more ongoing into we've its met expanding receive shortly. objective safety step is ELAHERE signals

pipeline. briefly the Turning of to rest the

In triplet year to at data forward in top in de we from reporting later our BPDCN we track our in this line PVEK from AML second the look frontline ASH, on cohort PVEK, are data novo XXXX. pivotal pivotal frontline program, with and expected

on and In we IMGNXXX addition, our and pipeline. and in our IMGCXXX are reinvesting expanding progressing, remain capabilities research focused

of Chief report Scientific our expanding we Officer; to strengthened and Hewett that Financial commensurate ADC the to Lauren in pleased platform, well are continuing Chief leadership appointment we the a strong commitment parallel, ELAHERE continued commercial in to and pipeline. I'm as advance an with team balance our team Heather Officer. in experienced invest of management welcome Lastly, for positioned to our expand we recent and with White our innovation and place as With sheet, opportunity

to With our to over Isabel? that, I'll Isabel cover call turn the commercial progress.

Isabel Kalofonos

first half quarter receptor cancer. of strong a make sequential another Thank In build saw as continue and quarter. growth established year we positive momentum the standard you, commercial portfolio strong Mark. positioning as XX% care ovarian The the the of upon the team also to progress in towards prior delivered versus quarter, ELAHERE the we the third

adoption a of strong including: We access solid to reimbursement unmet high since it cancer. patients awareness our are an combination novel launch the or with ovarian advanced and a with and treatment experience physician of of and increased our execution pleased and benefits factors, brings is performance customer-facing X this in to coverage; the rapid area believe need; commercial due key teams;

more detail. Let me each some of take to factors address time key these in

the of into insight a high Starting year need. launch, of while First, identification seen unmet of patients conducted FR patients let testing for of diagnosed alpha next and component newly me a the awareness initial to diagnostics our for patients, area observed the as therapy. we standard overall into panel being the have I adoption rapid increased on with some almost launching an the the of dynamics into and moving FORWARD line share incorporated

with of care XX% up that familiar a ELAHERE are over is the of needless testing, the oncologists from standard adoption. research the time It of FR incorporate testing XX% approval. has physicians treatment will indicates under enable into of becoming to baseline not been say, to rapidly to decision, alpha at Our market that

Since endeavored tests with a at number our to market labs. the launch, provide X of we have centralized conducted largest

that As at XX,XXX of the the end of tests. number quarter, stood

metrics However, decreased our performed with calls. on approximately tests, certified subsequent discontinue of number on reporting XX and to branded into tests labs now visibility the has the will

We to will, expectations. alpha the positive receptor between in with which line remains foliate our however, rate XX%, XX% and report continue

a cancer at unmet addresses adoption. Looking ELAHERE ovarian high patient among need platinum-resistant patients.

with the to great. In initial the and a we has earlier uptake the key to patients been has first expect will shift vast of become quarter, growth. driver of is later trend, and later of future life the by from need therapy. in lines. strong This progressed, as launch were indicated And this steady lines the As majority low

our to aligned we XX% our the second both benchmark, commercial coverage launch, of factor, Moving to access another within level exceeding and lives policies effort months for and our alpha key first the over team, investment. by secured ADC. X of Driven of Medicare

the of seen use utilization with low, inclusion the have medium ELAHERE including a we high guidelines, population, bevacizumab combination broad in alpha with in lines NCCN presentations. and in and FR of addition, monotherapy related In

driving Third, of ELAHERE. our adoption team a strong execution by commercial

active customer-facing highly have since team launch. Our been

continues our quarter, resulting and accounts. to they third During in both continued in reach engage growth community to priority broaden targets academic the

repeat Complementing significant of account with percentage a new is generation accounts orders.

pleased awareness. groups, While academic awareness oncology nonacademic across consistent cultivating place priority and We are XXX with setting, customers, roughly of the quarter. increased since XX% quarter community institutions and and and experience. increasing physician prior from we on oncology. our community-based academic of institutions aware patient in came to Based lastly, And August with continue This the market a medical comprise ELAHERE. and April, largest positive nearly and during to see high XX% research, physicians on increasing are experience our we awareness a has awarded physician over doubled the over especially physicians

continued our suite provide MIRASOL ensure support team, to Given and the to compelling the by full a to this from positive robust affairs of experience. data who medical engagement patient has physician and to

reports with As experience field to regarding clinicians a enthusiastic from efforts, feedback from their their the relate ELAHERE. testament consistently

our In awareness is And of brings biomarker I earlier the high, date. FR due market ovarian already a alpha Awareness increasing testing. expect ELAHERE pleased FR convenience growth with patient continuous just and as cancer. are one, testing performance with summary, the a and research, referenced, growth XX% based in-house benefits physicians with of to Two, journey. of in on advanced testing the we patients very alpha primarily to increasing we by the indicate testing an number

breadth combination, in utilization prescribers continues adopters. to clinical translates experience of depth unaware physician monotherapy into gain prescribing in our rates physicians Also, new and monotherapy physicians that our higher both our and As combination. data with educate of research current affairs increased and becoming we both team anticipate previously education in and on shows medical projecting

the the of Third, of over LIC the and care setting. therapeutic of in Improving events. to the treatment we support efficacy into standard including to adverse platinum-resistant given treatment, will also compelling the expect therapy. increase experience benchmarks Fourth, lines premium historical of relative see increased rates perception with earlier in moving of management

the With program current also are that, expect into of would development ELAHERE to utilization Mike? gain study, to and pipeline. and broader and Mike the turn additional a we additional provide call our over we to color to the demand currently Finally, ELAHERE. insight like I fielding future on

Michael Vasconcelles

subsets ELAHERE European present subset Oncology the Society objective of subsets. in versus signals our Thanks, Isabel. inhibitor IC on benefit session, September. chemotherapy therapy physicians III consistent by clinical Dr. We at reported insights Professor of survival, rate or PARP to trial findings choice Bangor, of Dr. in for XXth valuable Gynecologic/Oncology the ovarian oral platinum-resistant prior overall of With of in efficacy were ELAHERE's compared with no of arising in the an these safety lines X from highlighting and new ELAHERE investigator chemotherapy provide pleased data IC presented University or MIRASOL, progression-free defined at prior Bangor randomized cancer exposure. from response Gynecologic Annual survival. analyses, to benefits and these additional analyses Congress to number Phase in both

care further broader expand into as fully to the disease. standard the ELAHERE program, platinum-sensitive development Turning of we clinical aim now mirvetuximab in alpha-positive and ELAHERE the to ovarian receptor cancer position label

are of advancing We trials clinical these X currently support objectives. in sponsored

evaluating is patient and safety The noteworthy by Let's received platinum-containing or a and X X alpha ovarian factors. FR medical platinum-sensitive have prior single-arm Phase start efficacy platinum documented at need our key monotherapy with this in patients of predominantly have high population cancer driven who II therapy with PICCOLO, unmet lines trial growing, in mirvetuximab least

is today therapy available if with platinum-sensitive disease, lower associated for cutaneous a by First, subsequent even clinical response achieving this measured response patient efficacy of of criteria of line a therapy is tolerability. But meaningful these and the probability patients an meets duration both decreased reality, limited. objective each and platinum decreased as

Second, data subsequent a that emerging clinical with therapy. negatively PARP inhibitor impact may indicate platinum containing efficacy of the treatment

the setting patient maintenance first-line patients, importance the if No in the PICCOLO. will. further the for PARP Phase reinforce inhibitors treated Level you one data regimen the alternatives. many and for randomized in evidence, the No observations for Given population treatment enrolled in of treatment III exist need

the populations. As design both design patient we patients with platinum-sensitive non-platinum Therefore, of upon These standard for assumptions. platinum-containing statistical agreed analyses established of there such, monotherapy to synthesized data its historic disease. and and care is in drove final standard no X-stage trial, regimens similar trial this later-line

response as study additional important for rate endpoint. was the Safety of secondary key The tolerability endpoints and objective primary former objectives. response. the were Regarding duration

we have an by the a that from Based In the historic results upon would and PICCOLO have above. trial benchmark objective XX% XX would inhibitor confidence prior set other In XX% or established rule rate, data received actual referenced fully response XX%. response objective trial, rate observed of data out objective been rate size to I of total treated, words, exceeding whom an apart a positive or the these of assumed therapy. Because objective response PARP enrolled trial confirmed intervals. response hypothesized XX%, the observed patients most excluded require rate based upon investigators

entire ongoing. on remain the of receive patients response population for Based mature, mirvetuximab. the the trial study until duration continuing remains design upon trial the As today, is of to a number those prespecified treatment,

the the least full primary of However, we based data at response response assessment response report of we are the achieved. share We The XX%. today that overall on of interim rate investigator-assessed XX% when safety, point an objective excludes has rate been anticipate to and in able an end objective study XXXX.

platinum-sensitive data detected bevacizumab. PICCOLO Also today to mirvetuximab thus mirvetuximab with the insights earlier previously FR-alpha potential are far mirvetuximab's believe numerically in date, largest from in new shared as expressing for data reinforce in we signal cancer that patients ovarian combination I've these platinum-sensitive note, published no the we data meaningful trial ongoing of disease, have demonstrate safety or The reported set set of PSOC.

tolerability the mirvetuximab across in profile mirvetuximab becoming already safety care with assuming eventually of seen remains the a underway Assuming and that we've that platinum-resistant in program, observed PSOC to new a trajectory similar consistent disease. that development in PSOC standard

mirvetuximab of PICCOLO, establish trials choice platinum-sensitive in X advancing in mirvetuximab monotherapy cancer. are In combination addition agent designed we to the to ovarian evaluating as

robust second-line our platinum-sensitive mirvetuximab mirvetuximab versus bevacizumab The This first plus of Phase data bevacizumab builds the the maintenance, in care, plus study III bevacizumab evaluating maintenance upon in platinum-resistant setting. standard to is the maintenance our longer to combination benefit mirvetuximab. combination. is to therapy duration NCCN for which of the led for looking in designed opportunity setting, This from compendia with setting establish the trial this patients even

The II of platinum-sensitive in in progression a study low, and ovarian mirvetuximab folate U.S. with cancer the second Trial enrolling advancing until medium and carboplatin Europe. are Phase high single-arm with expression. continuation is receptor or mirvetuximab plus GLORIOSA alpha disease XXX level Trial evaluating Both a patients in XXX,

Moving our program. to pivotal second

in line We blastic trial PVEK, top or continue patients relapsed/refractory from of to and Phase anticipate dendritic frontline II with cell CADENZA neoplasm in BPDCN plasmacytoid or data the XXXX.

PVEK rare at advance we this indication. the of we triplet. refer the venetoclax as with encouraging PVEK in are In continue new Hematology Association PVEK, AXX efficacy which a combination presented enrollment our azacitidine AML have as about data option tolerability program the year, with Meeting to and we Annual we in to trial European and observed this earlier PVEK in excited our Given as potential

each December. step from to including inform in study pivotal data schedule to leukemia of at acute report optimal the the to ASH triplet, this were cohorts diagnosed first expect PVEK myeloid patients We planned and AML. further newly in enrolled frontline a Two development, guide with in development clinical venetoclax designed

we cell for MacroGenics, an which IMGCXXX, ADC analysis interim expansion in protocol co-development now our stage is with earlier continue ADAMX-targeting our non-small next specified year. we progress to cancer provide update on first-in-class As completed, expect we cohort, lung to the plan programs, and our after to

to IMGNXXX, Lastly, tumors. we are of progressing alpha receptor anticipated. escalation endometrial a folate our receptor and our is dose cancers Phase ovarian I address next-generation broader range Initial as antifolate trial ADC, targeting and proceeding of alpha-expressing exploration is in

will I cover Lauren? financials. to the that, our With call over turn Lauren to

Lauren White

Mike. Thanks,

balance $XX.X recorded on of million the and of of For primarily of $XXX.X We cash sales we XXXX, from with and ELAHERE, sheet. $XX.X $XX.X $XXX.X in product R&D EPS royalty comprised of in million of SG&A revenue, $XX.X million, expenses million Operating expenses million $X.XX. were noncash including generated remainder quarter of $XXX.X net third the revenues. million with the ended expenses. the quarter net We in million income

for unchanged. XXXX remains Our financial guidance

expect million expenses million sales, $XXX between $XX to continue $XX million. and $XXX and between excluding ELAHERE operating and We million revenues,

XXXX, quickly end financial Lastly, the since share full for full revenue are fourth and we XXXX anticipate like I'd when ELAHERE approaching that XXXX we year we providing quarter announce to results. guidance year of

the open With questions. for that, we'll call

Operator

with Newman Canaccord. question our John [Operator Instructions] from of line first coming the And

John Newman

continued Great work, successful launch.

ELAHERE, second, on increased terms therapy this use are two Just year? in what data to continue a quick you're looking curious, combination ASH here? And if a questions. share of ELAHERE expecting of in grow use? had be And also ELAHERE duration just question at if should On we Avastin I'm as of with the for total see then to seeing you

Mark Enyedy

questions? Isabel I'll ask answer to those

Isabel Kalofonos

yes, pleased in John, continue are as million -- we well, third very the the we quarter, we said, with performance $XXX in sales. over

continue both We in utilization drive in the to combination. monotherapy

to our please So have next see preliminary that, in you there continue PVEK? that, months. grow we continue the on on repeat Can and indicates your involved, could to data few we is we that, question that yes, research and say, market will growth

Michael Vasconcelles

respect -- our data we data essentially, ASH, on and we solidified of X. schedule the have that as to Yes, Mike. move I think, triplet to year in going upcoming it's mentioned as the comments, have cohorts as have at X the as I John, much we're prepared the we in with dose as forward

So efficacy data, study. ongoing safety data, an obviously, it's

we'll to And so just able those on something what that's time. to I sort going think of response But take the expand I data maturation fair shared. of a is with duration to respect be more bit

Operator

from question Schmidt the coming Our of line Guggenheim. Michael with next

Michael Schmidt

market? on positivity as your the a more in setting ovarian strong you opposed point you this then Mark, flow Amazing patient so through PICCOLO comment what And platinum-resistant Isabel, have quarter. this It's or cash other bit to at cancer result ongoing reaching setting? subsets launch treatment platinum-sensitive could think a ovarian other on been job very trials is in reeks in a this comment on you launch, cancer trial time the Congrats obviously. you how far. in potentially to secondly, the could share

Mark Enyedy

start and ask points I'll and address additional Mike, here. then the Isabel to Mike

in we we a this a at important you see share to some way position are the is looking trends. point. business The we aren't quote specific at So

of I the but think characterized product steady as slow this look we the we've as growth at utilization monotherapy.

as of patients that, is of by when in growing lines claims started gone we into well. as out, majority what has later and earlier the were we combination So use line fourth with products data the we see And the in therapy. of time the see movement parallel

in a don't you know And want that. to specific point position at of but you sort number, to give anything add if share -- that? back do I not to just to so this a and Isabel, stand

Isabel Kalofonos

an significant that both is of and to breadth community steady to just in high and a need and this I adoption what academic are we say pleased is all accounts, would No, across unmet area depth see the savings. like

increase So we continue terms expect will in of to market this share.

position time. We not at this comment in are a to

Michael Vasconcelles

for Thanks, the question. Mike,

we the PICCOLO terms the there rates in to This available are better single-agent We we to digits, heterogeneous heavily been In single with just platinum-sensitive XXs. look population high we've on pretreated which platinum-sensitive you, of least disease. double of to -- across so when response PICCOLO. assessment interim rates with where the that objective see this foundation with a to expect a respect see And is share build we which remind the monotherapy, here very at we are objective than a assessment few I platinum-based imagine able between can't data. response ongoing patients is therapy, to And objective rate. and is response cancer in of and options. anywhere interim an high because high XXs digits XX% an low doublet a ovarian study

So the of disease. this foundation for sensitive continued sets really a work mirvetuximab nice

Operator

the And our next Markets. question with Capital Darout coming of line Etzer BMO from

Etzer Darout

continued on and PICCOLO, here. Maybe for study. ELAHERE the additional execution on thanks the on Congrats color

sort could on that on sort had care level-setting of perspective question know sort as you sort expectations a ADAMX the of at for study? standard duration And standard and Just I to comment well. of of a if of just wanted all response of care, of from

Just mechanism. of ESMO we the TROPX about the at some thinking recent sort got from of data

at of on particular non-squamous first there's all a the sort of of dynamics of or cell you a could potentially a sort for not comment non-squamous of ADAMX non-small squamous sort mechanism or sort the histology. and and preference terms population, cancer preference In versus if whether response

Michael Vasconcelles

is Mike. This Sure.

respond question Let to second the first. me

with signal ADAMX histology, be if short distinguishable that if on expansion see broadly expressed long that any today this that we'll PICCOLO. we cancers, from more of looking the forward to response to not the sharing any just is forward to example, detail the population based is to be to the specific I the given respect in want be going interpret able going look And respect other interval full we think really just data. to, to with detail this really first forward we durability this point, questions I be expression your that are But but it essentially context interim and for important looking objective have With the there's that seeing, when factors it's of that also patient is data and at there's -- we're data, look that. we're to to in round the in that that across assessment epithelial sharing full share to -- question, the able demographics, better rate of the even continuing the platinum-free the broad next than cohort. to we're and out around relevant reinforce more assessment are broadly response year, interim obviously what we're

to we're in And I expect So we've I year. really said, forward that shared think next looking we that that. like

Operator

Next line question our next the Boris Peaker with of question coming from TD Cowen.

Boris Peaker

Congratulations for on questions me. the Two progress.

And And So first, PICCOLO guess, on maybe on I get therapy? general of current DS-XXXX of early products, thoughts Daiichi development? that's do kind just ELAHERE, stage from the duration curious patients? is to you second in increase what competitive in the I'm how your the expect,

Mark Enyedy

that that to have therapy are Yes. among we patients the of been to data sufficient allow Boris, the us treated. project have at duration not this claims point

observe stay drug rates tend longer. We have the to what we reserve same that and combination. is rule, general earlier phenomenon a As higher patients lines in use that in with on response

Michael Vasconcelles

terms going ahead the data an work the you data, in to ways It the referenced that of week space which space, from think the interesting. on those were your data there's Boris, and about to in we're terms eye to question, it's but me, years think, It's identifying with in progress, appropriate candidly, least ELAHERE. and I something at dose. want to going be Phase It's that Yes. platinum-sensitive the platinum-resistance keep some experience. Mike. where second of we're to we're with with looks the Clearly, presented, respect And at do last to to respect are I

Operator

coming JPMorgan. Brian the with line question next from Chan of Our

Unknown Analyst

moving next from to use the on trajectory just and should early about in discontinuation the natural how year of think we about patients of sales give path post on How think Mark, you on think for then we we the analysis? about your next label look due progression. trajectory final final the How dynamics the an the PICCOLO. two quarter. will the you efficient forward? combo leverage think do analysis like versus for should regulatory should Congrats line PICCOLO And year? And conversation expansion

Mark Enyedy

Thanks, expect Brian. to continued see growth. start. we I'll Look,

We from promote when be think not breadth What guidance we we in the increasing of go in in this is now, trend see is increased rates. also February label And the at point for both observed testing, to that directly will from of and what and our relates awareness. opening give But research continue, SBLA full the well as that survival as are results. are information in market of depth research can't with market prescribing reasons year submission the rising that. with see able We with Isabel conjunction comments. combination. increased subsequent and with the our we monotherapy earnings so the education, approval, Right the to treatment market year as the data the we'll to increase call there we and it next that our her report in we articulated should currently

ovarian last in earlier out a the first this the So specifically We've that therapy is decade. in approved almost need. drug area this of is new cancer an pointed and unmet

contrast that what particular, the inclination have use expectation the do the we the MIRASOL is cascade. that, rates research in earlier observed of increase. the we care. and again with drug here in treatment an And when And against And treatment in the compare is will so to we to ability the data, then standard

do and these so And anticipate today. the the we questions of course over call

was -- as growth, say steep base, so say the off as of be not continued expect slope do think coming would $XXX-plus of will million I is that I in also fair quarters. the couple what that the but again curve it of it's we past And to

Michael Vasconcelles

Mike. is this And

Regarding -- is yes. This Mike.

keep early Regarding meaningful yes, all, -- foundational that clinically patient available is study -- durability This the data presenting mature set to so your in we're keep of the be importance will was in because in that mid-XXXX the be just patient your just until this of where response enrolled first data this year. second question full of right? in at, mind reason a of last is unequivocally data. population. mind, And won't And let's the this

an data. response. I'd rate have And it of we objective put way of So that like when with gives know mature that durability support compendia no that until of data overall you with given expect, today, regulatory because sense judgment just durability these what we importance response what the listing be. authorities of we fully of to will to data a dialogue eventually I on will the see data full reserve full context there's response the into that

Operator

the with question Ramsey Our of William next line Alexandra Blair. from coming

Unknown Analyst

the on Congrats all progress this quarter.

XX% data appears the that that questions. earlier present two that responded at patients. PICCOLO. looking it you rate? full response just And the confirmed first want guess presented -- PARP confirm that's I So the ESCO, presented naive MIRASOL That PARP-treated on then, you'll rate XX% mentioned to quick a the response I data. patients that, actually at better potentially than

case? So some color wondering just be on the why that if you could I might was provide

Michael Vasconcelles

Yes.

Mike. is So this

not. the are it in exposure surprising so slightly and in there that Regarding necessarily question, inhibitors. the point encourage interim to this an the We that data prior mentioned or that profiling I'd was data generally, patients that to to by I planned is that your this in better The short out inhibitor therapy. we is outcomes, the interim trial, PARP presentation, of yes, demographics in patients assessment. at -- these and say, right, tried MIRASOL are as is question, one of the more are a But And at apparent set when a look the ongoing enrollment. on confirmed. full caveat is, you in it's of of well, that Mark second are go population. an that. not outcomes and And to molecular assessment some look it's this back appropriate long It receiving is that with first important and terms think PARP differences PARP-naive parsed the based respect see the still following population are patient with to analysis number patients for And I'll subset

we we when we share full the in process the a of providing researcher, year to to presented that's be in data in so reserve an we're caveat those need clinical about And full XX%. the could when of next data course, minor the rate like But really why confirm parlance at are of something mid data, clear this. there least shifts data, of and response objective the that the talk that

Dingding Shi

sense. makes that No, Okay.

And seeing so time. durability you you're how It but just people long sounds treatment are that. based have kind on of like over on been increase confirming

Michael Vasconcelles

we I why the some duration full Yes. that guidance data mean response of expect XXXX. providing exactly is of today the would of maturity issue the we're in the

Operator

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

Peter Lawson

comments around back CDH Just ADC. your going to

kind unconfirmed durability between data up are kind at the should physicians you your I XX% Just pick rate molecule? above response get a curious if that. to PICCOLO, thought on and will Does or kind And kind the XX% think go XX%. if on of and back of holds to just mean there then of molecule there's could and how of you that make and what of

commentary around you would So of kind that any be a made, great. details detailed find

Michael Vasconcelles

prior in mentioned, point, as question Yes. do Well, I which mirvetuximab. And patients there sets number data on see generally. the relates to remain of are we to a I'll that that say responses kind of the late our second is

So that at response XX%, an say rate interim of therapy. that we to of number of confidently can patients remain this see be we on but those assessment, cognizant we objective need just

dose to out to that so rate respect molecule the a Like you really be grade first me, disease-related Phase could a I could think I higher. early looks lung at got it's day like to were interstitial we're final With trying be there has said, that some it to higher your Yes, we've X I said conjectural. figure deaths. earlier, the interesting So like objective I response signal. question, mean,

cancer. patients compared think and So benefit little to becomes a potentially for a cancer. meaningful someday hope to physicians platinum-resistant sit from demonstrated to try survival choices I in make that treatment are to that hypothesize ovarian But has that able where gosh, to in therapy ovarian going it's through were how work premature it I medicine I a about

Peter Lawson

What's detail. CDH? alpha Perfect between additional overlap FR and the

Michael Vasconcelles

when But share give We're understand understanding a that, to we'll course, looking we able I today. numbers hard any to Yes. be of have that. of that. better can't you

Operator

question next Our of with coming line Kelly from the Jefferies.

Dingding Shi

on have great I quarter. two. Congrats another

in to approval, launch share you the consider also, Firstly, And question with program. on your And be the we should how able strategy cost of AdamX associated moment? at launch? regulatory another would Europe the regarding the the

response a is the in -- is cancer, cell response? upcoming share it could it the non-small of So durability Is lung interim based analysis? for update rate or you on what

Michael Vasconcelles

I'll question, Mark the I Isabel just about your or to second Europe. tackle briefly may question and respond think

expansion Phase study. a I of So a this is cohort

-- -- about in And to essentially complicated to to and nothing forward patients wait prudent mature able cohort having we cohort, share it than therapies more those that really think the that to in It's to totality. that look remain for as and sort so that of it's it's data the year. sharing be it's if just enrolling to next on data sufficient and prudent fully

Mark Enyedy

Great.

to I'll ask and marketing we next Europe, last our start think for of were approval And the terms late had Isabel validated comment year. EMA an application. us nicely in that sets that pleased very we authorization up so very then But week And further.

we there. a then dynamics And market. Isabel incremental can market headquarters of with access, little a the bit subsequent launch the I'll just ground be events, terms regulatory with a on in are starting Europe to team overall, the the like business. a added for established address in forward. already that the this countries small little talk support But we Switzerland about as is the to we're let Germany, about and a support there'll around bit And the to market build in maybe talk the key functions comment In sales then and here on and modest investment initial and stack go

Isabel Kalofonos

is and the you. Yes, majority Mark, highly about shared market the Europe the XX% thank have patients the for account concentrated, really in Well, we of there. XX as previously, of centers

with Mark alluded a to, reach to these able as So small we investment, are customers.

really We with Europe at our of in this that in also ESMO, And KOLs relationships a as excited efforts to are very have and to this. you therapy in we supporting show, strong ASCO much have started have and our already available course, presented our them engagement. very we

all In going the research, in of have U.S. in our up our countries, very basically we are to the Germany, in that in the addition to seen preparations start our to we excited market and launch replicate success are we that, team

Michael Vasconcelles

other point with experience has which X drug to there that, is base And add our to physician the Kelly, already. tremendous

enrolled Europe. were the MIRASOL, of we at SORAYA. XX% in United look enrolled we patients at of when the look of vast More outside than were those So majority the and States,

And group experience so this significant drug. with physicians a the is has already of that

our So about we're excited there. prospects

Operator

And the from from line question coming Asthika our Goonewardene of next Truist.

Asthika Goonewardene

off, that the growing too what can't some is see. you but congrats expectation. seeing is here, can color us you're And in line with so I buy of in largest specific sort That's you coming quarter on on the population here side give far? a bit most at to of First what be off-label for rapidly. least the understand what use especially on good robust another off-label aggressive

you the And some then look also need this our you I I'll of what think have the think statistical DOR? could about beat PICCOLO suggested that be are, can trending response? and area for at, us that be to duration what we're that here as us As what models could of to PICCOLO, good a on tweaking hear helpful you've about what us here. ORR And just but given for little is I in could good. where mentioned guys you tell calls, previous an add Anna also

to So you share in ahead well you you're Or order PICCOLO a of that I confident lastly, with see to it discuss data more about the now that of feel to if do And want can with present public publicly that need NCCN? just the in-house? presentation? then as NCCN you the seeing

Mark Enyedy

about start the and with can PICCOLO CCN. question. talk And me So market you let

this ovarian prior that So of alpha of product discretionary platinum-resistant are mind of in to the in therapy label, who terms outside keep use FR cancer label X the patients X our who've first lines positive. is to received thing in is

early consistent very that guidelines line patients. product physicians was the the that with what -- observed So we on NCCN in later using were

that qualify is alpha So beyond prior FR what who a where patient FR the high speak. alpha who monotherapy, be therapy close as as continues are not are We then patients X that observed to who getting not might and nonetheless therapies, had there as might be high. FR alpha would considered -- we expression

Just a alpha FR intensity is XX% of high reminder alpha at as patient's sample tumor defined as FR to the folks, X-plus staining. expressing

to point readouts. respect so there's whether positive comes negative with is or expression X level. of a that intensity it the One a X-plus score But our labs, on numerical from report pathology back when also, based has And it staining. meets cut

and percentage with XX point market anecdotally XX, up will it's for XX% and in boards advisory So that XX, is research increments, initiate so so reading What monotherapy. hear XX, XX, XXX X a to our in through downwards we then stated on. physicians many

expression where are product around And levels with and to go for use. of guidelines patients include down, supportive low As the here levels the opportunity again, use alpha of medium they the expression. combination engage there's FR the NCCN

use a to expression -- later hard combination those use combination of an not that? And a I X monotherapy to at I then And we through which a little data use research use point, call from and your show It's had market able this of to the data we claims lines. so the match if we prominently and And -- think can't don't see see of comes I we're who do it of to anything with therapy. to perspective you as we a relative patient own the studies market of things. both know -- of on said, research have to in lag a sort XX% produced increasing our data, existing increasing add most match you a want bit. anticipated sort number in little level that

Isabel Kalofonos

the of guidelines and monotherapy low medium or the has value And some centers. addition NCCN I want guidelines has been the silence combination. to it Yes. say just around high included awareness lifting increased, in some to NCCN of to has of of in the pathways

therapy, used combination. yes, we addition of in in particularly and on to in use mediums So lines later see being lows,

Michael Vasconcelles

respect to fourth and And third your With questions. Mike. this is second,

we and relatively relatively a interval even final that's a considering non-platinum are short to you see exposure that PARP they imagine about we'd a we a help durability the data interval. with subsequent would the rate thinking those about along disease the set, And perhaps of point full that Let with of hypothesize short who therapy natural trial that me there's data if the interpret patient history, that's make around going long. lines, platinum-free at And I platinum-free this inhibitors explicit to a bevacizumab. patients see or in have when population the full the patients like like population substantial influenced is But this of the haven't is have response, that patient a has about just platinum-sensitive been important have that's dichotomization clinician that objective sensitivity about. short to or interval whether that really proportion think monotherapy expect be platinum-free we proportion can -- because about when that's appropriate platinum stage. has data agent when quite the relative data, response important versus clinical when think the in as next mirvetuximab the patient clinician third And still that an a year a prior relatively important

data with and response. all demographics rate response to interpretation of that of those it's factors objective to needs incorporated data of able and durability context be So the into clinical respect the to the put into to be the

updating a think assumption for be guidelines. their the I NCCN, around working in NCCN question your published to the should context looking that to is respect review sets with data of And

Mark Enyedy

We have question. X time more for

Operator

Certainly.

coming question Lee are HC line Chen last the from with Our of

Unknown Analyst

hear me you Can okay?

Mark Enyedy

Yes.

Unknown Analyst

Yes.

ELAHERE Can approval provide conversion So full with I additional Takeda, from you more license approval, -- that to on Takeda payment. there's that? just believe upon the under the details accelerated agreement

Mark Enyedy

the So I those. of that and Huadong license. would comment have won't milestone on I Takeda for to to exact I approval. get you amount back license, payments on comment full the the additional can upon on does call

Well, thank Okay. look the forward progress important the growing an you pleased us and business. all joining product. very continued progress We to there. today. We've for in with got are we Obviously,

of and also So We've exciting to forward therapy. geographically got second us ongoing and And as we into hear an lines portfolio. pivotal earlier moving about you'll go expand we the important pipeline we drug this more reinvesting in look our speak, an program as research capabilities. from

to that highly a important set ADCs of growing differentiated We an therapeutics. We've think skill it and are got of therapy. that class relates as class

forward at I and to you updated, ASH. many again, keeping So look see of you Thanks. we'll

Operator

you conference participation. today. your Ladies and end Thank for our that for does gentlemen,

You disconnect. now may

Immunogen (IMGN) 2 Nov 232023 Q3 Earnings call transcript