Immunogen (IMGN) 29 Jul 222022 Q2 Earnings call transcript

Good morning and welcome to ImmunoGen's Second 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.

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 second quarter can Investors release found our press and recording immunogen.com. this This a website at under Media & call the section of of be Chief Officer; today our and our Mark Susan Anna are Harrington-Smith, Kristen me our President Altschuller, Officer; With CEO; our and Enyedy, Berkenblit, Medical Chief Commercial CFO.

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

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

you priority and set date business, accepted for and of BLA XXth. FDA us with past quarter, today. thank and we across made importantly, morning, Good the MIRV for the reviewed This designation significant a progress joining November PDUFA

time. been this Our agency at has the that and ongoing for mid in advisory with we FDA committee were advised productive cycle no interactions have conjunction review, with our an plans

later cancer. call. of provide the actively fully monotherapy update with As Kristen for we for transition into launch ovarian readiness our integrated launch an alpha we global a MIRV will positive progress on receptor preparing company, in fully the potential oncology are patients

top our III pleased results now terms line XXXX. to trial we're share from we and report development, is In expect study this early confirmatory to ongoing in Phase that fully enrolled MIRASOL of

the MIRV our to process advancing program and also are efforts are in expanding populations. are studies. our the Trial GLORIOSA development end, in that patient we into XXX move of broader initiating We To

pursuing cohorts our in Moving to this detail. second and AML, and and both pivotal more reporting the year. data indications Anna both BPDCN anticipate in in programs these PVAC later of we are PVAC, will cover MIRV program, important

in unmet and progress our against to We develop our pipeline are as earlier the we BioTherapeutics by ADCs. identified reinvesting deploying by research high Oxford Linker-Payload of with OBT in pivotal need. Technology forward research our collaboration to programs, look targets our proprietary address deepening Lastly, exemplified to our recent capabilities with Novel the stage cancers

half our and short milestones shareholders to Anna positioned a was meaningful and programs. color the it believe long-term. I'll an clinical create to value the we Anna? that, With of and call patients first of over number year turn important in additional on both our well exciting So ahead, our for provide we to are the

this the retrospective limited a a with for ovarian benefits remarkably study months, of patients portion tolerability background consisting consistent patients become for considerable SORAYA, demonstrated in safety median significant of consistent long heavily with XX% pretreated over short I the needs, prolonged options control Mark. gastroesophageal MIRV Thanks population. particularly from over received efficacy for SORAYA and integrated Against studies. a remain events. additional of and further reduction to present and At in in single-agent differentiated multiple grade Preliminary survival MIRV. standard-of-care was with XX.X analysis safety work of included of to tail of low this Kaplan-Meier durations prior toxicities. rate tumor and our and disease across demonstrated bevacizumab are those update support benefit population. Phase of platinum-resistant SORAYA ocular in we low Treatment a potential XX% data with profile rates, associated an unmet FORWARD The ASCO, of and study SORAYA cancer, high I having response who the overall summary excited a primarily reversible response of and The we had shows PFS curve a patients believe were pivotal new pooled

Mark enrolled confirmatory top early As MIRASOL anticipate year. line study fully and mentioned, data we have next our

We intended also platinum cancer folate-receptor MIRV study PICCOLO, to in advanced in patient support of arm with enrollment our label recurrent expression alpha monotherapy patients ovarian of high expansion. single sensitive

expression in study alone the process in benefit potential which approximately as Trial is which combination followed of platinum-sensitive ovarian the single intended cancer MIRV platinum the with or patients registration in are we to Trial second-line a the XXX to II Phase high of reach, inform low, platinum-sensitive bevacizumab cancer study III path setting Phase alpha. cancer. look XXX initiating evaluate As a MIRV sensitive of Carboplatin choice plus arm versus by continuation medium folate-receptor maintenance will recurrent GLORIOSA to in expanded and ovarian agent and XXX, position in MIRV of MIRV of we maintenance ovarian plus is our bevacizumab

data program to September. excited at present and IGCS, MIRV we're additional from ahead, our in ESMO Looking both

preliminary We our pivekimab study pivotal in also data CADENZA of of the year. by frontline from anticipate this end BPDCN efficacy

venetoclax cohorts share and In expect PVAC patients. AML evaluated in Ib/II relapse the this is azacitidine ASH to December. study frontline addition, Phase from of patient expansion data enrollment in advancing at we and in initial And our study

stage from trial targeting Regarding ABC X anticipate of initial end first before pipeline, co-development class ADAMX the in in we dose with year our earlier escalation Phase sharing our MacroGenics. IMGCXXX, data

first Phase I'll turn Kristen to types, FDA tumor expect We fall. I progress solid to meaningful enroll to and our With that, preparation. on also study patients the call IMGNXXX commercial made of information from this our addressing over our CMC touch Kristen? the request multiple in regarding

our potential a infrastructure. advancing end, imperatives Anna. These To successful early from an adoption in in-house a approval; of reimbursement receptor year, later of pleased BLA and Thanks, of to we ovarian out the access patient FDA's our broad are SORAYA medical commercial with redefining and four are: ensure and ensuring deliver positive experiences patient data of management. and and outcomes compelling with on the and launch. seeking this and review, with were and payer we upon that key priority physician acceptance for testing supporting folate expectations a We anticipation with tailored approval positive and testing MIRV centralized are build for to seamless guidance experience finally, standards for alpha cancer; establishing patient platinum-resistant through focused education

as efforts potential year. approval Importantly, continue support this physician folate anticipation around receptor of adoption alpha enthusiasm we grow in and later of testing, and the awareness see educational alpha FR of early progress our to

expression Tissue potential that the the MIRV’s and to Roche will the for is folate partner commercialization Diagnostics planning for used Our launch. of of receptor alpha be approval patients time companion at test diagnostics

majority this base As offer a samples the is testing cover day barriers, bring testing the readiness. that accept to institutions will the has be XXX% access sponsored that testing includes four test choose. IHC patient institutions plan large launch, we they cost of labs which our one reminder, a Post-launch to will labs. in-house so test an run have central diagnostic System, two to At we of for minimize installed ready if Roche the patients. our To program for target ability ULTRA on BenchMark of will Ventana’s expect to

key aimed will MIRV prepare on to for of look range to to access remains come engaging financials. experience, services a cover date delivering to patient patient our commercial the up provide of priority. seamless turn to keeping you access a a our forward hub. that, to over the market, we at I payers get Susan Susan? close and With call positive We our preparations our as build team To to we launch. working to market is As and with finalize

you, Kristen. Thank

we comprised expenses from the administrative Huadong the selling, company's million million expenses, For XXXX, ended revenue, cash million of of non-cash which the which expenses. from Medicine. includes substantially of quarter $XX.X milestones and remainder Operating research and on $XX.X and fees, in revenues, received and generated from the sheet. million second were general million license $X.X of recognition with coming of second in fees quarter $X.X royalty $XXX.X balance and $XX.X previously under came of We million the of agreement $XX.X with million collaboration development

for million and $XXX and be we to unchanged, $XX between revenues to expenses cash remains cash $XXX million, operating million million. financial between XXXX expect and between continue million, $XXX and $XXX Our million year guidance and and end at $XX equivalents

reflect are of not year advance timing the revenue does in increase expenses pipeline. expected second MIRV continue in Operating approval launch of additional the the readiness further range the activities, product guidance the up Given ramp generate to as sales. of potential we half MIRV supply and of to

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

Our first Newman comes with from Canaccord question Genuity. John Instructions] [Operator

Your line is open.

for taking question. Thanks for the my and update, thanks

question one to had Just start.

to On a the the be study, you're different that recently in that for wondering have enrollment same if completed you'll centers the GLORIOSA additional bit there centers to that or able be utilize MIRASOL MIRASOL using if just some will GLORIOSA are the study? than Thanks.

Thanks John.

process year. look our right we're later in now forward Phase of this So GLORIOSA that initiating randomized enrolling II and the study to is patients

U.S., from XXX Europe, sensitive already XXX alone, plus in sites, relationships the with platinum in have mirvetuximab we maintenance Asia bevacizumab bevacizumab wonderful at as well versus study over a as throughout countries and Pacific. over MIRASOL recurrent Looking sites the the setting well some actually

branch And that have investigators and in of And trials a course, countries, up invite sites participate clinical bunch and additional to areas new then mirvetuximab the out engaged GLORIOSA. new opportunity going so of so including already are sites, have we into running. new certainly get can them to we'll to

great. additional And could ask question. if one I then, Okay,

to plan of initial the individual Do your kind path accommodate just have they and centers for long about is for in any choose plan in-house spoke shakes how out? simply receptor diagnostic alpha. bringing you might expectation whatever of explore how terms see that to You the start or to testing after test have the folate launch

Sure.

institutions and speaking on to have are very the site, heard based So eager thanks our they the have for what testing labs we to base, in start customer on question house. larger that

can Of them time that approval utilize get we But customer and while do that bring for will it have to base that become to central barrier trained way immediately in of labs upon want central it they process so our starting hear start house. that it in takes labs capability. them to the have course, many and a any doesn't that

Michael comes Our Schmidt next with from Guggenheim question Partners.

it process, facility cetera? BLA respect with tracking to I just around CMC great guess, will the had of else et and share to confirmation a -- panel. anything hear Mark, sounds there that from you review be are some the FDA you Could how like, you inspections,

at date PDUFA So point. tracking the this are expected months we're inside four given from

sort cycle that So, mid constructive they've from the no one advice terms they of terms at would with this plans but got in are say us. inspection’s introduced by as At agency. very about are for we we blow dialogue individual process I'd in be point inspection the the components we the committee I agency blow tracking of and review, would what wouldn't this hope, expect. where in feel helpful, we think in proceeding as is time, the And the time, that we're advisory on importantly good where of an given

I a was the market where maybe, terms help know, drug? the the terms how well, figures out I BPDCN get think dollars as of about just of frame you of we'll in this data the And in IMGNXXX in for sales then us year are later market wondering size market opportunity you the date, this potential in just commercial initially? could on bit but

bit kind a little about think talk of to I early price.

bit this so rare a even a heavy the indication are and thin. little And is data

the somewhere similar X,XXX a estimates So newly market at this Europe sized our in patients U.S. here point. in there best XXX are, between are diagnosed and and

one one of So, in rare would sees expect rare range with disease, the products. for that pricing consistent what oncology

a kind I that at. I of would those are model is think the benchmark -- I think -- the So, efforts look

on the focus rare development indication, opportunity again, here. is strategy the I to and upside think drug this the both thing So,

this to chosen speed study a then to on we've FDA is do the patients drug what indication and expanded the try and near-term, at potential drug patients BPDCN XX align focusing on course, So the the frontline full and in to market approach is, of take in rare with and AML. the there approved this lead indications get reach of in look with

frontline what with patients, moved triplet from and cohort. with expansion the with a We'll we cohorts at azacitidine. fully relapsed We have ASH data in expansion venetoclax cohorts, forward gather combination can the and from have

we're is to with talking upside fast a and indication, dissimilar and excited thinking or about an accelerated expansion. market label to the strategy, So about opportunity, smaller I which we're approval then it, think, significant not about, from then where

this approaching we're how that's molecule. So

Capital Etzer question next from comes Our Darout Markets. with BMO

First from one for at maybe to what new speak mirvetuximab the the nature and we ESMO if of at just the data meetings? can me, you get could and IGCS, presentations

Sure, Etzer.

always, a early the couple released abstracts. in will have September as we'll September pharmacology abstracts Xth, and So Paris, of clinical be

related magnitude I collected an show FORWARD of The So [clin the to for patient profile we're life over looks our best have data regard data physicians outcomes pharm] really, for chemotherapy, improved which we like in of chemo. with chemo the of disease that And reported quality going over symptoms mirvetuximab presented reported data from drug. from abstract to patient understand, an FORWARD I. our also outcomes

understand And for life. use of so And early terms going and inform enrollment the additional their data City, have quality patients study MIRV track to in of September from year. potential share to in October, MIRASOL York really combinations the the to to those those and Bev At SORAYA the in we the end IGCS, plus of quality that which is on benefits life study. long-term our important MIRV next of data data plus and is data completed from of information and of has early collection data carboplatin will are at we're New

important I I look interim because that from top months readout, there's I no MIRASOL. line we data milestone. away that from only And think assume guess, MIRASOL are guess, the another assume enrollment at at I few an isn't MIRASOL the I'd Is a least update is correct? the And plans that for that

correct. That's

next with Cowen. Our comes question from Boris Peaker

of to is single My platinum generally, need considering what or focus PICCOLO are curious on of see more the strategic arm do monotherapy I'm in in trial further trial? studies. development sensitive this the the is you patients first kind question and of you what and kind mirvetuximab

interval months. high selective platinum frontline their have line more greater pre study, interval piccolo are is patients they a has or the FR alpha with the are not under days platinum-sensitive or patients do and resistance. population that relapse, So And -- platinum like sensitive disease potential from which nothing us as free where can it's patients recurrent free PARP MIRV growing a maintenance for a yet, as a meant clot this they when tumor PARP and in PFI when extending technically inhibitor getting in sensitive either PARP settings, the monotherapy they continuous platinum platinum had setting disease. more than And later the inhibitor in pressure six bring the between, in been their

significant. the platinum. that line be later yet may not you would quite platinum patients at these so more to platinum-sensitive be And hypersensitivity get, round as another of disease sensitive reactions for can more the And risk you're

context, later it, Phase for study our call anecdotal already disease. activity line that generated in I MIRV, nice, very I showing we've in would So from platinum-sensitive data

quite phase we being PICCOLO engage showing potential that out, benchmark and gather additional data already that a sensitive from And emerging beginning are or on a arm in help approval based no would platinum we this patients data emerging I PARP allow to I come year FDA mean, think as over with us will PICCOLO data had inhibitor study. will are with think it's then the support next therapy, align longer benchmark will us so the enrolling that who've to the newly on study the single see population. what published. so would that I And to FDA to be

what My you on study, the set forward look expectations CADENZA can some of efficacy last you question to?

endpoint we study, frontline is CADENZA them the that setting. used FDA the XX patients ELZONRIS primary So being endpoint with cohort aligned pivotal in and CR/CRC, upto of get to with on the approval this a same the allowed

tolerability with a aligned with we toxicity. cycle, in we perspective, of Hepatotoxicity, as better the rate we rate and this statistical better terms ruling that a capillary in are syndrome, anticipate knowing for no small profile that of potential less perhaps we really first a heme good XX%, fatal because or the from hospitalized than so response And CR/CRC leak FDA out as ELZONRIS, population, less

them we encouraged was FDA underway. so led is and us with to designation, toward the cohort quite pivotal And with data that that shared frontline the of currently breakthrough that design therapy they guided then this

Our William next Blair. with question comes Hsieh from Andy

proposed? label for broad the about of question you think cycle have do mid successfully a I reception I mentioned that review. through you that the I FDA's Mark, gone the curious am you've

So no negotiations label at point. this

the goal the inspections of relative and the here components core of on think I the discussion forward to move on then with specifics So application, through get the label. the is the here each of

curious And would available? right four after communicate you how there's stage, one use in-house of with that to that the for approval. transition labs see could approval. physicians MIRV of I'm two at upon about just Kristen, kind central labs, Is a it that I'm mostly in be could that detailed these potentially this curious, locations where they equipment online, into could no identity where

most sufficient get to a plan used And say broad guide base We we given what and identify. two is commonly us actually four. our broader base. to how two of think they're We that's helped labs, often a would to be used, surveyed the customer but

that's that one goal. use then a they someone and of day has approval the can So if preferred lab

patients is in about primary of believe free forward a platinum free I X of about that question platinum platinum subsequent the the study that interval Got XX%. the for it. and interval And Great. free X one and interval, between lastly, kind regarding platinum XX% Anna the --

XX% but X or primary to also refractory patients X. think, I were XX% SORAYA about excluded,

months primary also fall? MIRASOL you that free expect first are platinum X secondary four or interval the curious patients Just excluded, refractory X how about between subsequent and to would won't

MIRASOL primary months first their with FORWARD and within SORAYA platinum progressed refractory patients FORWARD bad who disease. regimen. excluded dose interval in same little These of primary, both month. are their stringent we I, disease with patients for a three exclusion the a had free criterion of platinum Andy. last Sure, did their more primary I, a and really patients of really, we That's what like than with platinum

the percent a improving small. platinum has say but And is that primary and patients with of population of the refractory effect so disease I MIRASOL, would SORAYA for at overall [indiscernible] slight quite

And so what are MIRASOL -- are except say and can essentially identical I SORAYA. eligibility SORAYA is the for criteria

You had must have prior bevacizumab.

And so see we we that be anticipate similar MIRASOL will in quite what demographics SORAYA. the to in

Our with next from Kelly question Shi comes Jefferies.

The question Anna. is for first

outcome So recently this this. settings. months as curious, on VBL's for and just all your for paclitaxel viewed Phase thoughts control showed PFS we at a should III medium worse of patients? high alpha I'm X.X expect Is Trial our paclitaxel [indiscernible] performed arm,

Thanks, Kelly.

added study demographics months. up you're really of patients with to seeing not to to disease to you because of paclitaxel ovarian therapy. arms what and platinum both X.X This in look eligibility going there, They the cancer, in prior probably they five and as that forward patients to patients allowed have around was sense question your referring a progression mentioned a with patients that the pretty different. that to the lines field. So bit paclitaxel about advance the criteria a allowed alone is is the the But sensitive resistant enrolled, survival, study of months their X.X free disappointing we to it in ofra-vec medium is platinum the for compared this really

three patients excluded platinum they They allowed with with without However, cancer. prior therapy for resisted therapy. ovarian or patients lines anti-angiogenic of prior also

we a me Also, matters. we paclitaxel, know into had until one put And demographics, except that how their to prior them say, it's the see hard many that know to data two or context, PFS for so lines. therapies don't of prior

other to for you range studies in the demonstrated free point PFS where And we've progression I been that an improvement would so, survival, certainly already has paclitaxel. are is what analysis in But FR we is as subset. a know as from alpha I, survival high even FORWARD that the our selective XXX and overall subset even from perspective plus as not subset there PSX in

and same in high FR point, that plus mirvetuximab in we've so, demonstrated recall then benefit you patients. patients that do PSX in will had for to already alpha was your arm that a analysis a months. medium with it control the paclitaxel and And we expression, high the our do prognosis over a FR of worse I MIRASOL. may PFS anticipate alpha have arm months And And may X.X mirvetuximab exploratory X.X be

follow-up. a have also I

In physicians settings launch community X,XXX you mentioned prep, initially? have equally, of and you initially. Do academic terms focus preference Thanks. a on targeting previously you or centers

Sure.

our base on there's when focus absolutely will chemotherapy community folks particularly utilization customer concentrated or most. from, the where -- the very chemotherapy who will points, come the the single we and look equally a So agent both business call the academic among and setting we at higher utilize

split So, there's at were community. between look -- account equally when and XXX market, we of for academic they XX% that physicians the

the from hands customer the speaking really as as they the experience will, know academic backs who are to folks dedicated they for have wall -- with if we do have designed first the against academic very that eager we've folks that model, are these to both who we and their community, on option while approach. the clinical are see equally to nothing And so MIRVbecause also to what patients being a our can that already setting has setting setting in they the in the give say, they have trial, an are we them. have community to you address dedicated tailored to folks So adopt and

have equally are available. eager they mirvetuximab So to

question Wainwright. with H.C. Ramakanth comes Swayampakula next from Our

RK have couple there are of of This but from Wainwright. just my H.C. ones. quick questions Most answered, is been

to to what physicians. you you're thinking structure academic a MIRV, about tailor your both launch the forces are So of commercial for of the trying Kristen, and when planning to community sort especially have,

will XX model commercial comprise our associates. of field So

we have provider institutions, managers, what account and Then same tier those are top strategic that field associates, do are Mirvetuximab to XX, experience. a at who specialists, important driving at the They're be on is and a to that will used. easier demand time, really call responsible they but it same yet time cover community launch. what managers practices field will as comes settings when the navigate, harder have to will there. account upon equally we but where XX little they focus for little oncology have be academic Mirvetuximab the is navigate, chemotherapy the replacing We And

Thank when And are plans regarding from then, you with in filing that your out that. quarter for fourth Anna coming I timeline PVAC, CADENZA in -- filing with data application the the of so FDA? the mean, what profiling, terms

Yes.

level at also disclosed haven't is BLA duration there RK, and timeline the an important endpoint. for primary our the we complete of endpoint certainly So is CR/CRC is a response granular what

So that share once can provide we've into a consideration taking we locked certainly that. will BLA guidance, into timeline and

Chang with Jonathan Securities. question from comes SVB next Our

MIRASOL are for just analysis for for question, the number fourth still events expecting in clarity, requisite you primary of First to quarter?

Yes.

it. question, you. you about toxicities commercial barriers are second commercialization Got Mirvetuximab the how you thinking ocular strategy, uptake? just to as think as And potential about Thank

Sure.

remove way. alpha patients So the get with that commercial could any if are But we the want. you to need I barrier establish our to standard-of-care expression. same as Mirvetuximab ovarian the and in chime is cancer platinum At with anticipating our FR time, that we for in start resistant goal Anna high might launch can

market access. You about think

removing reimbursement barriers that around for a cost out challenges. We is any team access of patients, market have pocket

around the and understand them work Mirvetuximab we physicians patients also and them, when plus and not have their with sure prescriber see so manage generally the if focused low their infusion ocular nurses that are events. making grade and go having also the local and AEs ocular that both they resolve, to we our expectations our that team can team they manage only them. do ophthalmologists We by expect ophthalmologists on adverse manage with they get do can that And they to this educating base that we expectations which is will

they what this. is full educational And -- know best and to once do expect they educate in we that can So their they patients. have trial our will around folks we from a effort something hear what can experience they

data add Yes. more trial as to fact Mirvetuximab, that discontinue were ocular speak to really we've had trials adverse and think, more sites And events. who we of the tolerated clinical I that expanded the would than is I Mirvetuximab just reach in well the our and to X% patients new less for clinical

sharing together. with so And this an so can that from successfully we we're colleagues, really those education do lessons commercial perspective our learned

call further turn no for to questions. are to There I’d like the back over remarks. the team closing

milestones forward have Well, year our a to ahead first excited again, with thanks clinical well first key about productive joining the of look some on a updated as progress. morning. very business keeping and We us us had as the weekend. regulatory for this half in of year. nice and you the our the back product approval half and We're prospects this of Thanks of

program. the concludes This

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