IMGN - Earnings call transcript Q4 2021

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Operator

Good morning, ladies and gentlemen and welcome to ImmunoGen's Fourth Quarter and Full Year 2021 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications. Please go ahead.

Courtney O'Konek

Good morning and thank you for joining today's call. a progress that full and financial issued of a year we results. recent our fourth today, press includes release summary XXXX Earlier quarter and found of release our of immunogen.com. call a press at Investors recording This can Media and website be under section the and this With are will Q&A. Smith, Kristen our our Commercial Officer Mark President Berkenblit, for CEO; Anna CFO; me Chief Altschuller, Medical our join today also us our Officer; Enyedy, and and Susan Chief

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

anticipated uncertainties and issued morning section described of original Mark. these our filings turn or FDA cause forward-looking business I'll These call actual update for will our the guidance SEC statements. product regulatory financial and statements in product at over subject We to and in include uncertainties our date certain our of available sec.gov product product the this statements. forward-looking immunogen.com. such statements we anticipated at with this timing risks call on forward-looking use is Factor design candidates, to recent differ and the certain for commercial statement press data the that, and on our of respect website of clinical to undertake speak our and of the to With of and and the presentation release submissions of obligation clinical as results trial could our the and Risk presentation this the annual to any revise to our clinical launch strategy, materially no most other trials our benefit candidates, trials, of development those and our report for from risks candidates, cash Each runway. XX-K the that These candidates, Form which are only

Mark Enyedy

plan progress productive for In oncology Good with year objective joining becoming resoundingly study advanced morning, integrated as delivered as the our we programs, largest compelling program, AML, lead points, with research mirvetuximab progress, and move a our company. Mirvetuximab towards to Soravtansine on these we was our SORAYA, in generated in this our today. us significant a commercial ovarian significant established results for executed single cancer, in IMGNXXX the in company. we across to for launch everyone engine, To cancer. XXXX. particular, the you With reignite ImmunoGen, the earlier-stage our momentum support of expand entered XXXX laid fully data and positive of history financing we've ovarian the with first the pivotal our and business a business in generated starting thank groundwork

approval is and the initial by this positive accelerated folate the this patients disease. approval we data in to half this Our late reported the November alpha quarter preparing We're year the end, launch believe monotherapy for track To as receptor setting mirvetuximab submit gain mirvetuximab with in us a of BLA for with in and accelerated on for a top of are for this unmet need. top priority the approval positive year. significant to end in potential platinum-resistant second SORAYA position line

approval. trial our to support expect generate data which MIRASOL also is third We full from confirmatory to in the intended quarter

are four of are ensuring positive early standards and alpha Affairs, approval, of organizations tailored further our payer Dr. and investigator-sponsored sales, testing broader for patient in-house Smith patient commercial teams focused we've trials Officer, and mirvetuximab the began of by folate cancer, preparations marketing patient physician we and strong Anna mirvetuximab program management of studies on combination and receptor of populations education redefining positive in adoption We're Head well Kristen delivering medical choice are off and key detail ovarian for and advancing Sales. shortly and supporting through to in and which patient our mirvetuximab ovarian the a designed priorities, building experience. education platinum-resistant underway expectations mirvetuximab and additional to have affairs establishing and agent our supporting in for experiences become from centralized in medical discuss Launch for move cancer, in recently Commercial our with and call. testing, and comprehensive our guidance step the with company-sponsored led Medical most a will regulatory parallel now and best-in-class a of In added reimbursement number broad Chief part seeking As Mimi building Huizinga. strategy access towards into seamless mirvetuximab Head start outcomes

second frontline Our expect formerly progressing sunirine known pivekimab CADENZA as second nicely. line and in in We've the cohort is our pivotal BPDCN data year. study half of advanced program, this IMGNXXX top in the

combination present in PVAC azacitidine Venclexta to at efficacy in higher triple relapsed/refractory for to cohort initiated patients session addition intensity frontline are the and during pleased Based the oral to cohorts. and during data expansion by regimen In on observed, the relapsed encouraged triplet move profile an into the in safety we've we the BPDCN, year. from with an patients AML ASH and particularly these data, expect and were evaluating

trial program in which of portfolio, ADC from Phase this targeting later X in year. first-in-class tumor co-developing sharing data are solid IMGCXXX, anticipate our multiple and earlier-stage we types ADAMX with our dose Regarding this the escalation continues MacroGenics

hold FDA application pending IND request. our the alpha ADC. placed next-generation some production submitted also receptor a We Due antifolate in to CMC-related delay information IND responses IMGNXXX, our our a at to product on for vendor, drug

and are following to data submission agency. look first forward this to our generating patient responsive the enrolling these the We to requests of information

intellectual pleased our property from announce leadership deal Turning proprietary strength with around our this to of deal global This our business platform. month. demonstrates in development, licensing generate Lilly technology we were a Eli to Camptothecin and earlier multi-target the ADCs and value

million the support launch with will fourth in collaboration through These inflection proceeds to Lastly, we on we Anna? in quarter roughly completed ended gross cash. that of and XXXX. and million $XXX over year an turn product with business generated upsized follow-on With programs. additional the funds initial $XXX offering in into that, the and other our provide I'll Anna clinical to points some the over material color the call mirvetuximab revenues together

Anna Berkenblit

Mark. Thanks,

activity with pleased in three toxicities. were the patients for are in have extremely November of with XX, X.X with on pivotal eventually the this to X% disease. the nearly over considerable with cancer, substantial consisting at XX% with months bevacizumab and still population, duration most Having light that cutoff in was half our unmet pretreated chemotherapy in been of particularly investigator, a with lines from a despite responders cancer ORR, platinum-resistant that study data express as Five platinum-resistant of on platinum-sensitive rate primary by with DOR XX% with of designed ranging prior which XX% are XXXX, platinum-resistant line prior is trial. the heavily tumors limited the continues objective ovarian setting, often rates double response which frontline received whose bevacizumab. very mirvetuximab Treatment results of FDA of high disease. We advances These complete to to primarily therapy Median limited, prior the response responses had responses single-agent chemotherapy. ovarian results expected XX.X%, and Recall well of and of aligned of of mirvetuximab key was prior single-agent from of secondary doesn't was top receiving option are treated positive patients had need by which as cancer relapsed single-arm in response PARP a the ovarian SORAYA SORAYA including inhibitor. or levels therapy, available with endpoint who and objective duration population, received one prior response folate alpha the platinum-resistant patients the three All in endpoint lines patients response receptor as has time, therapy. in evolve. of happen of assessed or encouraging confirmed The

modifications an ocular common for is events, supportive is with known now studied SORAYA reversible for consistent ocular the which of events, by mirvetuximab demonstrated with in grade, most X% No adverse discontinuation and profile the The SORAYA care over events low event. low in The needed. in safety. The if treatment-related rate adverse ulcers safety GI mirvetuximab discontinuing to been dose been patient adverse tolerability or reported. of patients. including and have managed corneal XXX Turning just has one perforation were

the in ocular were events reversible. and studies, prior manageable predictable, As

with three PARP Erso of those will key set SORAYA survival full presented. the lines late-breaking during who therapy include on and of be Saturday, [ph] SGO Dr. Progression-free a also ahead, duration data session Looking prior including the will at inhibitor. analyses, subgroup patients present received response plenary March XXth. Data Amadalonas abstract updated and prior data will

are the quarter confirmatory we of of track readout neurofil on in to of mentioned, In submit end approval, accelerated mirvetuximab before this support the the quarter study is third full approval potential support in As later of first mirvetuximab the expected the BLA of to year. for XXXX.

mirvetuximab show ovarian cancer with an was to approximately single-arm rate of platinum-sensitive unmet our of recurrent to nonplatinum study XX folate patients response later PICCOLO an monotherapy X for designed platinum-sensitive We also lines label in a in intended data address support XX%, enroll alpha in patients the population. patient of PICCOLO, for potential this receptor continue mirvetuximab high effective increasing expansion. Phase need in With to option disease. overall

be approximately survival improvement of versus months in either bevacizumab or of We randomized setting, bepapizumab PFS mirvetuximab to patients rate. to designed Approximately GLORIOSA and GLORIOSA PFS bepapizumab. for three limitations of is These plus endpoint proximity followed not their year. benefit bevacizumab to plus approval in plus mirvetuximab in receptor initial to of study of third patients a with agent recurrent ovarian the platinum-sensitive provides close a label-enabling GLORIOSA, The of We position our plus X in mirvetuximab high for patients have platinum-sensitive support to strategy maintenance listing our endpoints with choice this all will completion alone platinum the maintenance of include compendia mirvetuximab overall formalized an in doublet quarter primary survival, doublet setting. who by of to alone expect doublet is secondary we maintenance design maintenance. four bevacizumab cancer, following bevacizumab plus therapy. maintenance. in mirvetuximab. of as a anticipate evaluate have combination bevacizumab highlighting the patients overall to folate bevacizumab progression-free Phase monotherapy receive data second doublet combination this gain progressed compelling from second-line the a initiating alpha available data the addition bevacizumab of XXX The About in modest response this the the potential platinum platinum overall second-line also

the planned Given the Phase duration expression ORR the The recently single-arm of and by Trial promising in of range Trial in our a we've X receptor mirvetuximab XX% inform setting. in cancer. a and carboplatin, medium an initiation Phase median of FR-alpha approximately plus activity study we to announced this path disease high XXX receptor across is response this followed low, with XXXX development plus dose mirvetuximab registration in carboplatin study platinum-sensitive alpha continuation ovarian with medium of high data folate patients, from I will XXXX. alpha or mirvetuximab escalation seen platinum-sensitive in months recurrent patients XX of folate with

Demonstrating including all observed pivekimab AML the particularly We composite venetoclax an patients AML relapsed sunirine, Phase encouraging, from targeting CDXXX higher we are data and higher ASH oral combination ADC. refractory initial December. pivekimab complete with relapsed/refractory patients, rate. in to rates, remission safety a in in an azacitidine our XX% of in and session at in ORR intensity ORR in findings XX% and of of presented X/X with cohort, response an study where these XX% Moving efficacy

by AML Importantly, triplet leak tumor unfortunately the combination therapies. of no characterized lysis despite pivekimab disease, demonstrated therapy reinforce syndrome, These capillary or outcomes core is the which as veno-occlusive for potential release. available data new cytokine pivekimab a

pivekimab patients greater was to a plan and presented cohort BPDCN pivekimab cohort capillary We leak limited remission featuring syndrome. session. with year. ASH, relapsed and we All [indiscernible] an monotherapy or later expansion frontline opened poster three expansion and Also grade three no at achieved AML in patients adverse a associated frontline data have events from treatment-related clinical complete initiate three in patients this

BPDCN Phase patients. cover the best-in-class pivotal potential over Susan continue frontline Susan? Europe a enroll and of for has the option US II We our line patients the anticipate BPDCN, the and become data With the turn CADENZA, treatment monotherapy to financials. to top during in second and call in study half that, believe to in relapsed/refractory to Tisotumab XXXX I'll

Susan Altschuller

million Huadong our milestone Medicine from agreement the We with Starting million XXXX previously million million $X.X remainder million $XXX.X the license of with with cash received Operating milestones. $XX.X The expenses came in in of balance from which generated the in $XX XXXX on G&A the include million XXXX. fees of full royalty of under year revenue were $XX.X from of and compared million, $XXX.X We with million Anna. $XX.X recognition comprised $XXX.X and came million $XX.X XXXX. million partner fee, revenue, $XX.X results revenues. sheet. million R&D for expenses noncash which of compared Thanks, and ended in collaboration of company's with $XXX.X expenses upfront

US$XX we million and million, million cash year-end and between XXXX; to for US$XXX Turning and between cash million. million US$XXX expect and US$XXX and expenses revenues to financial US$XX equivalents US$XXX at million operating be between our guidance

Given the mirvetuximab, potential and mirvetuximab. potential sales guidance for does yet timing revenue range of include from approval product not

expect closing will cash, comfortably turn over fund for the the Mark We operations I comments. with that revenues collaboration XXXX. that, our call anticipated With will into product current and to combined

Mark Enyedy

year Susan. of early-stage business. and and a our and end we PVAC, for We our product, entered with motivated now the build pipeline our exciting first the for launch data capabilities. advance and year, and to expect team further strong this Thanks, pivotal report the research prospects programs Between

in and strategy, look the value we'll for our generate open forward and place our people, more leadership have I significant in to long-term We for the patients. and days resources near business our call good With right and that, to questions. the

Operator

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

now is line open. Your

John Newman

Good for Thanks taking Congrats guys. Hi, my progress. on question. continued morning. the

quick Just questions. have two

assessed. survival what patient both just then SORAYA or is see population on at investigator-assessed and And if combinations to potential Thanks. curious we'll First for pivotal considering SGO, independently the data one progression-free XXX, from for future a just pivekimab you're curious and as study?

Mark Enyedy

Anna?

Anna Berkenblit

Hi, John. Yes.

from to include data will PFS So of I folks SGO SORAYA investor set which would event overall we SGO, and at have include shortly thereafter. will to subsets we data the have response, and to PFS data duration an as come encourage full the response well. we rate, will will assess

AML potentially thinking the have venetoclax plus about of triplet Moving in future pivotal on an generated already we Phase to based in expansion support question, pivekimab, escalation on a single-arm trial, we data relapsed setting. X in the plus terms study PVAC the zacytidine in are cohort and that in could exploring that relapsed/refractory dose now we're the

addition, those the and frontline we setting could support that randomized Phase then in look a to triplet approval this for explore for plan frontline should trial promising, X a In data frontline triplet setting. we to consider

John Newman

Great, you. thank

Operator

of And our from Michael Securities. next question line coming from the Schmidt Guggenheim

is open. line Your

Yige Guo

to questions different targeted the questions. patients baseline that is groups prior the the different you This and morning. two Two other talk platform are good Topoisomerases Guo our Anna, Camptothecin question, of payload And you. ADC? licensed type progress understand Hi, characteristics? with might quick one, taking for help MIRASOL, the in your Lilly, How impact for Thank mix to is mirv? could can Eli Congrats please Michael. one how without how us. Yige us And from you ADC second about response from the that the and you on thanks for bevacizumab. the Number

Mark Enyedy

Anna?

Anna Berkenblit

for a get not. in think FORWARD X to a We the are had half X, which bevacizumab mix when population anticipate And the with you include mixture where about prior similar more study, of tend both and to patients. without similar FORWARD patient I, bevacizumab prognosis they patient MIRASOL, Yes, of had In and patients prior so and patients Phase MIRASOL. bevacizumab, will patients worse the did prior patients pretreated. about half be with heavily we

risk These is to an first-line cancer. which pretreated. for stage that approved has only overall Let is heavily of me then cetera. sub-optimally move and with worse for et one debulked, are start ascites, the with Bevacizumab four several poor setting advantage survival patients. in prognosis disease, setting The patients in the demonstrated ovarian

for in Europe. you patients the SORAYA physicians that enrolled come So bevacizumab disease. can of many see those demographics we their in SGO study when actually reserve often the patients, the And particularly in of terms worse in terms to of stage of

therapies. to prior study, tease apart the therapy priors. three as hard support Moving that, had therapy versus prior two in number prior prior had XX% studies in number and us one I of point of of lines reference lines XX% FORWARD to it's of to also bevacizumab, a of for And patients bevacizumab of to

may of therapy. patients XX% had recall of that You three in SORAYA, prior lines

the in is prior heavily study. So more and we based the population than on anticipate SORAYA seeing worse I population MIRASOL what study the a pretreated potentially FORWARD

Moving antitumor are to payloads unique that to the Camptothecin our coverage broad next have a basically us. perspective give question -- from properties antitumor chemical activity on Camptothecin, and potent IP specifically so designed for address

I that's don't want what if think any to I color at this you add I know, can point. Mark, the Camptothecin to say payloads?

Mark Enyedy

Yes, just broader little observation maybe a here.

to multiple payloads in take some pride we of So to having apply classes ADC.

generations three we've at maytansine. got So of least

goal good have that we better at to tolerability. with see new our some in And of supporting the able the that of for team and have been additional activity this data payloads range index very were the been broadening the AP our we've classes. preclinical version context we Camptothecin deployed DNA-acting therapeutic engineered with Camptothecin other We drive got that versus and looking we've in least of with indolinobenzodiazepine the what

tech about payload. deploy the forward same internal for excited and for was Lilly advancing them with their that are time targets, we're at that So programs will about that excited transfer while that, moving

Yige Guo

very much. you Thank

Mark Enyedy

Sure.

Operator

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

Your line is open.

Etzer Darout

for Thanks the question. taking Great.

at from secondly, First to post perspective on pace late the benchmarks to setting? year? of one this in Thank how SORAYA, update, given line you. meaningful for start is for CMC with in half first And still population me, I and we update sort then bev IMGNXXX, will Phase guess this this on see respect submission are PFS this your you specific And of SGO? X the the

Anna Berkenblit

turn the question. take I'll -- for then Yes, we can I'll to question you, the over PFS Mark and XXX it

right. absolutely that the line is you're a So of has frankly, regarding cancer population heavily pretreated most one in a And late study studied population is bev this platinum-resistant SORAYA, been The setting. of post this in size. ovarian

So there good that returns, what tell the survival ovarian response you have solid been each response cancer if benchmarks. no therapy, But can there I progression-free law in expectation will, diminishing of published are multiple are you duration other showing the rate, as for line in is studies of diminishes. and with tumors, of

because is later-line really mirvetuximab. So have what data physicians studies the with you quite study, low. we've with into to we them SGO their is they're we these context for line from share SORAYA tell prior shared and that later at terms quite put these post-bev as they totality from quite based the on that known of with setting response when I data What patients, that on And PFS the efficacy data pleased certainly regarding in have will investigators will expectations SORAYA the experience. the expectations are PFS to said, get the of of that I patients you low data efficacy ORR, shared duration given we've of

have in confirmed. created you've XX previously data that and hypothesis in that that data the foundational basically response As we SORAYA we of in now we've that had patients tested SORAYA gathered the seen, rate overall replicated

put again, to you for Mark, have context the over XXX. into at for it So data you and we'll SGO.

Mark Enyedy

Yes, thanks.

we clinical the a to point comment, a in this issue. CMC is just reiterate made the So introductory that not

the to So including the relating submit to an Most issue in sponsor stability. period. And drug, in are cases, during may order agency a data the often review will product to data case submission. the IND required IND, the the the make the study the during drug letter in of CMC submit sponsor review included XXX, In data some requires those data period. to we the to proceed for plan FDA the available

we've for we substance that so to will drug delays review to were we drug not us drug IND data patient and the product at in required delayed the run. expect early this now come the update as course. secured slot updated updated early period, -- give too first give time but we too However, we a will to our off vendor, weren't we sense but a due be following meant agency on the planned update position terms hold of It's guidance got our we for the DP the had to generate production during secure clinical in better to in line quarter which guidance slot and due put on hold. it's able will We've you to a in product when

Etzer Darout

you on all Got congrats the and it. progress. Thank

Mark Enyedy

you. Thank

Operator

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

open. is line Your

Boris Peaker

SGO, I Great, going are result success be on to investors said estimate the to the of focused, PFS you thanks. and us probability forward MIRASOL. the to invasive of looking think lot obviously, Maybe of

could thinking SORAYA the translating MIRASOL you quantitatively? maybe to understand be how try to PFS help should So from we us of

Anna Berkenblit

Boris. Thanks,

much have PFS a actually by that from study guide not to data in SORAYA I to FORWARD PFS is like mean we I What single-arm interpretable. think is really better I that MIRASOL.

disease. from have You arm control antitumor to tease don't a of underlying apart the tempo activity the

FORWARD X.X was PFS investigator that And not that randomized versus months. that success probability ORR ratio method, X in subset identified that a independent MIRASOL, generated in conservatively. based scoring MIRASOL, mirvetuximab or why we on FORWARD of blinded at Phase study I. accelerated PSX hazard in much the median X.X. assess the the does I that's X.X of the when I may FRa-high the of chemotherapy. of choice If would MIRASOL. and so around in already ratio population a by PFS the study them either basically to to FDA The in investigator was And encourage recall you population review review data FORWARD are that designed independent approval, demonstrated looking And DOR. in is we've replicating in that technical Recall hazard the about target for we've want to they people activity we're And I, use support antitumor it's I FORWARD more to

So about already platinum have them in having not. that data be experiment with The activity the three MIRASOL we've we've prior is run half will and full the high, essentially inhibitors I. in one we'll the of one a demonstrated higher that in of of use PARP FORWARD priors, And very difference mirvetuximab same already terms regardless in FR-alpha SGO PARP resistance you'll population SORAYA to now. prior patients bevacizumab. The or percentage see of has at nice

probability our increased Boris. because PARP from answer prior we Thanks, the perspective, success about about So for of technical now the SORAYA MIRASOL data inhibitors. that what have

Boris Peaker

to in on is the you study in And study set expectation you for show question Could BPDCN. need just second it. the CADENZA what my Got approval?

Anna Berkenblit

so Cadenza the US statistical allowing in a ultra in between There's to for cohort and Yes, a new X,XXX Europe. enroll up XX patients patients year this of similarly XXX is somewhere really us rare and design indication. to in the

rate know BPDCN, the efficacy at that looking so data the in CR/CRC XX% one range. to for the approved XX% in we And the is agent

And guided this efficacy. we out that using, that rules to XX% we're the CRC size with in to. need us based would range from so statistical CR/CRC that perspective demonstrate a And rate sample a on that nice rate FDA that

Boris Peaker

my Thank for it. question. Got you taking

Mark Enyedy

Sure.

Operator

Hsieh next Our coming question the of line Blair. William with Andy from

Your line is open.

Andy Hsieh

year. Thanks all for taking on Great. the my last and progress questions congratulations

trials. So, the first all do question with to new has

I'm for to of back, just should FDA a on you the that a I'm trial space? for allows how how second design you gross sometimes case, net? Is if confirmatory just maybe study decided So different Kristen. maintenance have the use Anna, is trial know PICCOLO? terms duration demand? for and of Thank And And on So the patient the confirm think GLORIOSA delivery the be in as of drug you. a curious kind using I I'm ordering And kind prepare you the will can question if you about you this launch to as in on treatment about mostly system. also that specifically, curious, we have MIR, population? the distributed? to that's decided curious step

Anna Berkenblit

Sure.

Because to GLORIOSA bevacizumab So we've rates platinum-resistant the bevacizumab study recurrent mirvetuximab of Why platinum-sensitive the the in we which adding maintenance about study a data setting platinum-sensitive we're about maintenance versus the is this? showing doublet really in already excited in setting. beautiful are the are above for that treatment in disease, disease benchmarks. XX% generated mirv, XX% of response bev excited

PARP And to the recurrent doublet well-tolerated that patients have into that frontline active, a We setting. more setting. move so we know in want they and platinum-sensitive had them inhibitor disease, maintenance once the more of will already have

whole triplet a of a platinum-sensitive setting makes the in using lot sense. And recurrent so

have bev they take completed that, carboplatin a And progressed, this long alone. terms have So that setting, PR patients the bev -- you or in randomized in path their with bev all doublet stable versus of three treatment as adds who haven't only portion triplet disease, to will of about it. as entire that may we to four a they And for months a CR, recall they will only mirv of be progression-free bevacizumab so survival.

really these study to overall power targeted paradigm sufficient cytotoxic, survival. and also arm we endpoint duration us a anticipate arm primary treatment the on will and long The for benefiting the mirvetuximab, the patients. survival progression-free responses The is demonstrate an mirv-bev advantage that non-cross-resistant has patients. mirv-bev could for transform really we So on that be there treatment will a adding have

confirming to is about stand question it's to your the for we through. Regarding confirmatory could for need a with trial exact now in FDA us on and PICCOLO, a accelerated that not work little for path soon as too whether or criteria GLORIOSA a enrolling toward engage PICCOLO approval.

So tuned Kristen that. me turn it And over to for I let would now. stay

Kristen Smith

Anna. Thanks,

a your plan So to on we do question, using respond XPL. to

this And is like you comment said So net. would drop-ship our all net. help to gross on But an to like growth this help? to to that's time, we with us that on-demand a model. at Does or

Andy Hsieh

Yes.

Okay.

differ the the drugs kind gross really net of So traditional question other distribution. guess from how I is would or more

So that's am curious about? I kind of where

Kristen Smith

goal our to fees. of so the many is Yes, avoid wholesaler

Andy Hsieh

[Indiscernible]. Okay.

Mark Enyedy

no. Yes,

So I amount the there's massive wholesalers numbers patient of here, you volumes be no at at when distributed. a inventory need to and have mean to waiting sitting look

we're then our the that the and ADCs those having much most filling it's from ship doing perspective. this that very lot a XPL you attended instance. model. having orders a fees what net in would are here, drop In the now using and approach setting idea streamlined to up a and first of up efficient of We probably So a more sitting And use and tell of wouldn't model setting a the good at in be wholesaler. gross the can't that the exactly be come inventory to avoiding right

Andy Hsieh

Right.

you helpful. much. really Okay, that's so Thank

XX curious So Anna, two I'm duration been years. -- maintenance year, is if curious one Phase fixed or GLORIOSA, for it the is like that's -- I'm months so the for just like the there a set?

Anna Berkenblit

expectation be your duration fixed that do setting, platinum-sensitive patients the a you that there's recurrent Once because are frontline there to Yes, cured. the some you so you're cured. maintenance is in have going disease, trials, a of chance when not is

mirvetuximab mean, treated patients three program, had mirv say, be will one four toxicity. to years, toxicity I I But and and for going. intolerable years years, up or intolerable have the patients on even year, still to So across two we've until progression

both the as we've mirvetuximab that in platinum-resistant that as time of good terms doublet on tolerated. it's a setting. So tolerability had long well, the well monotherapy, And mirv-bev, the platinum-sensitive with quite and we the in patients for a of know

the tell going it's but know can't an in in platinum-sensitive is be I duration because that setting going So, you long. we maintenance PFS recurrent estimated quite the to these be long of to patients

Andy Hsieh

Thank much questions. my so answering you all Great. for

Mark Enyedy

Thanks, Andy.

Operator

coming And Shi our line of Kelly with next Jefferies. the question from

is line Your open.

Unidentified Analyst

for calling Shi. This morning. is Kelly Good [ph] Ian in

congratulation thanks, First, quarter. first, on the great

the for trial. really is question my MIRASOL So

patient is available optional for second regarding given more you assumption the to any Do control months. arm see ECOG Given might therapy arm is risk FORWARD how my you then patient consistent XX median the that in from X.X also SORAYA MIRASOL -- that of influence control chemo the term in may trial the for the the it's the weight And the status Do the treatment trials. I and and arm arm? is PFS, to consistent about performance of see status. outperform the that control outcome the the chemo XX and

Anna Berkenblit

Okay.

about FORWARD FR-alpha subset, the There question has some in a months. median platinum-resistant FR-alpha study progression-free PFS that months for have cancer a suggesting had would designed survival we the much X.X remind of your pretty ovarian every MIRASOL, is that's of factor. the actually are it high for out poor you I prognostic we I, in control that X.X there arm estimate studies on shown. what because So

single-agent FR-alpha with be the may do with chemotherapy, it So high patients overall population. worse than

on are I the So if drugs not underperform, anything, all are I might have and topotecan, might more that were they FORWARD your because MIRASOL in like about available. Doxil, options think the outperform. understand didn't are I ago. control The MIRASOL paclitaxel XX These been the options just arm years approved outperform study. control comment it on arm

now old So that like around unfortunately we're a single-agent it's been not have chemotherapies couple better of same decades. for the using there's therapies, more

underperform design to of anything, it, MIRASOL for needed control we that I it think the success So assuming arm the study. if certainly and might but didn't

that's a And to performance people ECOG the they're and status, status the X. lower perfectly The ECOG do. performance means Moving ECOG little means of certainly status X performance status is well. patients or feel tired X X potentially worse the because the with that's studying begin the because or outweigh the three patients know when aren't of the fit two, -- whatever to risks excluded four why you're that performance just you benefit poor we've enough. status patients

So subset the X, given have enrolled studies patients. not of from for mirvetuximab across a and population or similar a typically all we've any either X or distribution across program, status the that we ECOG anticipate tolerability is do difference efficacy an perspective we the

Unidentified Analyst

you That's so much. very Thank Great. helpful.

Operator

the Our next Capital. from of question MacKay Kennen with coming line RBC

Your open. is line

Kennen MacKay

taking for the and morning good question. Hey, thanks

and of Just there from or SORAYA data sufficient MIRASOL as and accelerated well? filing the approval is companion XRX other SORAYA additional Is doublet one trials point. next on sense? for the Thanks. that's trial, plus that a then trial data MIROVA in the what confirmatory there maybe be? the And [ph] again Ventana about Or also the needed the rationale the diagnostic could or diagnostic carboplatin talk for and just that mirv on you potentially can in from future the steps

Mark Enyedy

and the talk can Anna with you take I'll about Sure. question then harder. CDX IST

of data diagnostic. the The are SORAYA support the approval yes. is sufficient from companion answer to the So

four to our They've I discussed is Diagnostics, first They the we're previously have on to approved the these time think which on the being close Roche Ventana is modules working Tissue submitted would submission enabled CDx actually and have which which submitted at in they've PMAs modules. as the calls, into subsequent module. already them proximity track same our the with we've the file clinical as BLA put drug. integrated

Anna Berkenblit

of led Philip this plus followed the mirvetuximab randomized X:X for X followed who is, their of versus will Harder. be Phase study, to by carboplatin, when And And here our want a don't randomized doublet trial Germany to because to Dr. by continuation is MIROVA replace physicians XXX choice. talk patients with by able investigator-sponsored carboplatin about drug patients paclitaxel lose in to idea approximately mirvetuximab It's be the maintenance mirvetuximab, hair. they you choice

We have less neuropathy.

do first study doxil carbo and which carbo Harder to this CARBO so doublet standard And carbo larger the include mirv carboplatin really in it combine is so and for to us opportunity to directly plus compare paclitaxel, gemcitabine. Dr. for a

recurrent the head-to-head point the the activity And so help limited antitumor this doublet tolerability but our better at database of profile us a efficacy this sense is setting also therapies. available study platinum-sensitive against in the because get of will

development as the set will a prongs that carboplatin. data one of carboplatin taking MIROVA mirvetuximab are this guide plus potential So help it's the should we that to of from plus of further out point understand mirvetuximab three it is I doublet.

tumor in And of State. carboplatin US, mirvetuximab Ohio upfront setting, in out first neo-adjuvant tumors. Trial heard broader at XXXX debulking prong you a IST get mirvetuximab led of here a positive neo-adjuvant is untreated time earlier their The is of And can we study surgery. about is time the FR-alpha second tissue plus the patients population study, with the that the study available in third in that the then, which -- is

-- So three among sets, for sufficient data those between to the doublet. mirvetuximab those three we will support have carboplatin registration plus the path data then

Kennen MacKay

Got then follow-up. it. one Thanks. maybe And just

further receptor-positive boy used some on dataset there's could the with be you support or disease, that if high mentioned potentially SORAYA evidence the there and is Or any or Accelerated receptor out disease be you. see as outcomes. fact that positive what support the publications sort for some that or team to worse patients Approval there to become FORWARD not, most data You've might Is certainly have of other to that? factor that that added submission? the Thank supportive do that available working

Anna Berkenblit

predictive support not mirvetuximab. So prognostic We we as need accelerated and any of regarding FR-alpha FR-alpha benefit a do our is from path approval. toward know data study factor to our SORAYA that

duration clearly in response benefit population tripling response rate, SORAYA, very and We patients identified have clinically from nice of FR- a high meaningful tolerability. the biomarker with near of alpha mirvetuximab a who

mirvetuximab, chemotherapy, one we is I the versus predictive post clearly to of is again, more it data FR-alpha rate low, looking the focused expression, when most because, in with progression-free prognostic do frankly, trial answering now for mirv But hoc from do the then from now where patients FR-alpha demonstrate we mirvetuximab. for FR-alpha that is it you plus or know patients. mirvetuximab. prognostic where ovarian while, who the who patients with matters be enroll that a on really FR-alpha so at only patients down carboplatin a one set that from we're the activity worse response maybe development that very set this that's analysis can see it's because a -- high we to from I circle we're going broader the with of that's have to that's we available this high benefit all set control the understand benefit perspective the assessing data data you're arm, factor. maybe and I point chemotherapy from you the nice of we cancer we'll where approximately patients question what terms randomized patients think, set patients physicians And of we And mirvetuximab XX% because can this a patients mix the FORWARD And road, most. being that inadvertently The spectrum a can the Kennen, across the do back really, higher therapies, of point need did a question, of there, with the and how benefits robust high where data and and right, we of can medium have best to survival. we the on FR-alpha investigator choice mean,

Kennen MacKay

And looking your next seeing to forward Thanks, it. review. in you Got again.

Mark Enyedy

Thanks.

Operator

question from with next our line And of JPMorgan. coming Fye Jessica the

open. Your is line

Jessica Fye

for at see a will number? just to the my median swim spider expect PFS SGO. we waterfall taking Thanks Maybe see guys. Good morning. we plot, or SGO? Hey, a Kaplan-Meier question. a And specific on also Should one more one plot, PFS curve

Anna Berkenblit

Jess. SGO, to Come

the data. data visualizations the for We of understand to will you have

Jessica Fye

for the setting, on mirvetuximab well as bars for And see platinum can about receptor talk combo what bev mirvetuximab great. for evaluating that kind maintenance you Phase Okay, float you or population? folate of platinum-sensitive either broader plus sensitive the X approval and high for the development continuation as receptor in expressing setting, mirv with the the as further

Anna Berkenblit

Sure.

XXX hazard is or of to for support survival, it's and X around progression-free that's we primary the designed have aiming it's full patients Phase study terms is about ratio in the we're GLORIOSA, the randomized So designed what approval. endpoint X.X for. The bar,

bevacizumab demonstrate robust efficacy for study alone. to And in versus manner superior so is designed a plus bevacizumab mirvetuximab this

of the randomized Phase plus that doublet, a anticipate needing X study terms for doublet. mirvetuximab that bar In for carboplatin we would

need be of would randomized platinum-based we strategies with a available are question, these again, standard control both because arm X answer an trials. powered study -- your the Phase randomized would doublets So Jess, that should adequately

is supporting need line bar the what we increasing of need is approval I where bar increasing unmet is data a forward going for FDA there with not approval. clear. support trial would an be clear That's patients and to accelerated in where the the to we I from the population in are unmet PICCOLO with honest -- is generated in PICCOLO that the the is on platinum-sensitive study. engaging that less that and forward studying bar We've handful setting study single-arm be and a the the already look think later a think

Jessica Fye

you. Thank it. Got

Operator

And question Earl coming our of next from Wainwright. De H.C. the line with

open. is line Your

Earl DeSouza

morning, if guys answered. wondered, could on color for Eli of Most possible, advantage been partnership the just us with the more more for good on questions guys everyone. question. give Lilly? give the platform? have could you taking Camptothecin I And my Hey, Thanks my you us color

Mark Enyedy

Sure. I program. about mean covered most publicly this said we we have what of

So were the Camptothecin. that additional our We noted an chemists Daiichi enjoying payload. for looking with their was

tolerability camptothecin therapeutic a would better topoX question better the we is inhibitor bystander potentially a least better was, both. at as the class molecule. efficacy the think better by a this either of with index molecule with expand think the So we exercise, could for with killing that and chemistry equivalent design have we efficacy better that we some tolerability, payload in medicinal What

beyond week or So then press that's comment what's the before. we basis. really issued of deal the And last on in that the release week I can't the financials included the

Earl DeSouza

Thank And congrats on this quarter. color. additional progress you the for the

Mark Enyedy

you. Thank

Operator

the And our line Sandler. next of from coming Piper with question Joe Catanzaro

Your line is open.

Joseph Catanzaro

took for to completion Hey, question or back it guys. If quick enrollment Maybe from XX one much so one my months I think Thanks I taking to FORWARD think I, me. here. just so readout. for about

just the dynamic, pushed that I will And but that could MIRASOL. not could beyond be kinetics, understand it's apples-to-apples for it be why there Thanks. you a help maybe other event readout window better whether rate enrollment So maybe if be there's or XQ. know risk shorter us things? wondering,

Anna Berkenblit

kinetics enrollment readout. on spot You're of the timing influence the

is the as we're the for the we of endpoint, the both event function enrollment, is the MIRASOL The the requisite So analysis as So that it's in endpoint will reach events. And well when right? trigger of primary events. study, a survival progression-free we to primary in rate an we number the in event-driven timing of has the similar I, FORWARD enrollment I, enrolling similar very, it and event crazy. rate given just three I. a been is from brisk different populations. up shot very should FORWARD MIRASOL months, like rate had enrollment the FORWARD The like With that very last be

bunch end. whole right patients the very of So were at enrolled a

So we the time events. of progression-free had to requisite wait survival a number good long get to to

so and right with the Here with for accounts the pandemic, larger like tail MIRASOL in study don't up the that curve a sharp the and being in we timing. that enrollment anticipate super-duper differences

line for in data And on top track so QX. we're

Joseph Catanzaro

Okay, got my it. Thanks question. for That's taking helpful. really

Mark Enyedy

Sure.

Operator

the And of SVB line our from next Jonathan question coming Chang with Leerink.

Your line is open.

Jonathan Chang

for Hi, guys. couple Thanks for questions taking of non-mirv me. my questions,

sales US$XX product guidance noted on from you any of potential this provide include doesn't that mirvetuximab. your million, First question, you to million US$XX revenue color can

if Thank could going? color year. that second So any could helpful. you granularity question can provide the provide IMGCXXX the on on is, you. And additional And this be as initial any when how disclosed guidance, then additional data you what's escalation reflected would is be this any in to dose color

Mark Enyedy

Susan? Great.

Susan Altschuller

and US$XX on US$XX guidance, revenues inclusive revenue Yes, we million. our noncash royalty so and to the of the license include million fees the to milestone

Merck the of include don't date because yet, we we revenues product So don't PDUFA a have course.

a potential factor of timing revenues in that. the so that And make would

So guidance. that's in what's the inclusive revenue

Anna Berkenblit

dose ADAMX with novel And turning antibody this the escalation a linker DMXX ADC directed and novel are IMGCXXX, payload. in first we to for

presenting So then in the X able we've also once forward to ADAMX in be we year positive escalation dose and to schedule tumors. further identified development Phase later this we'll data share recommended look dosing are we plans for and

Jonathan Chang

you. Got it. Thank

Operator

Mr. And session. back I call the have remarks. closing Mark that's any for would all turn the like to now our to time we for Q&A over Enyedy

Mark Enyedy

the Great. Thanks, joining everybody year us about ahead. excited today. for We're

then. talking number a look weeks to to couple SGO upcoming, of with in a important starting have of all of you events forward and we We

updated much keep we'll So thanks progress. very and on our you

Operator

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

now disconnect. You may

Immunogen (IMGN) 25 Feb 222021 Q4 Earnings call transcript