IMGN - Earnings call transcript Q1 2018

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Operator

Good day everyone and welcome to ImmunoGen First Quarter 2018 Financial Results Conference Call. Today’s call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to today’s host, Sarah Kiely, Investor Relations. Please go ahead.

Sarah Kiely

Good morning and thank you for joining today’s call. a progress that operating and issued of a results. we recent our third today, press includes release summary Earlier quarter XXXX be This the section a and our found can of immunogen.com. press Investors under at recording website the release call of

our are for and our Officer Berkenblit; and CEO, CFO, will Chief the Scientific Dave Johnston. join today Chief call Mark Officer, team Medical Q&A the session. President On our the Anna our Enyedy, Rich Gregory,

review first will milestones we today’s accomplishments, and of key During financial highlight outline quarter recent for the call, results year. remainder the

During With our in and investment the such I the turn that, uncertainties differ to call, statements. we results from filings. an with ImmunoGen will will use now are forward-looking statements materially over risks associated call actual included and Descriptions in Mark. the of SEC may our

Mark Enyedy

Sarah. us joining mirvetuximab, significant in with the Thank of highlighted important you everyone we today. treatment soravtansine we milestones, Building morning, a started cancer. you, with thank generated lead the women candidate, this with year our momentum of XXXX, and for ovarian for Good number progress on by

reminder, ImmunoGen our efforts four on priorities. a focused As strategic at

First, by XXXX. launched and completed development the mirvetuximab

novel IGN pipeline Second, our accelerate of programs.

through our financial our continued on in reach partnership. through And leadership build the position high-value innovation fourth, expand Third, strength innovation. maintain ADCs of and

ovarian platinum-resistant accrual in women well accelerated and patient new that completed the of objectives. of the of to we approval cancer, Over we've significant X made in were reflects last first mirvetuximab registration cancer four schedule. our disease. increased months With with need Phase and mirvetuximab, and these mirvetuximab week for designed for full the to support community we’ve treatments towards each FORWARD of progress interest ahead trial from XXXX, the pleased ovarian This platinum-resistant I, report enrolment

the study the FORWARD Independent on events as We also of progression-free following and of Committee we’re the modification planned Data report without based pre-specified study top-line in completed interim in the continue analysis, first The from recommendation on-track I. to this half survival futility XX successfully Monitoring will results XXXX.

as cancer detail with advancing expand mirvetuximab and ovarian will earlier to treatment positive these Anna cohort trial. the we of At data our for combination population additional the review Keytruda, in in II we’re data lines FORWARD addition March, move evaluating extracting In regimens in in single-agent into more a eligible with to SGO combination patient mirvetuximab you presented from therapy, shortly.

June in also maturing from safety patients XX to this look mirvetuximab roughly sharing, and efficacy at data expansion Avastin the forward ASCO. cohort We plus

a data earlier-stage to portfolio, dose both continues we Moving expect and studies accrual IGN from to in our escalation later ASH report this year. at nice for programs pace in programs

this in advancements earlier that clinical determine highlighting payloads activity enhanced addition, including ADCs. this well anti-tumor as three at for month, ADCs, ongoing the posters efficacy AACR, we In innovation insights our presented as and into factors of

Anna update overall, business I across detailed clinical So programs. turn that With the year. provide the start execution more our to to call over on sound the to will

Anna Berkenblit

you. Thank

the alpha both of have and endpoint primary with planned. monitoring both intensive in to for includes survival FORWARD folate interim pleased the passed subset I As futility is high patients the and in progression that very population mentioned, and Mark in population expressions. medium free expressors or PFS receptor the I high alpha and as receptor study or treat in entire The independent folate to are recommended FORWARD that study the we analysis continue committee data

FORWARD Lastly, full enrollment we also completed two ahead of months I schedule. in

mirvetuximab clinical based driven treatment on studies and consistent The encouraging agent data observed that events. and readout in potential the activity and platinum be single has We is to safety are a first resisting on half track will setting. displace the believe chemotherapy Based XXXX. as the to report the PSF in in XXX event on today, topline we of

conducting the earlier have sensitive therapy. evaluating immune agent. multiple full safely dose and it I, trial doses and to shown with we each with as Beyond FORWARD mirvetuximab can combined profiles disease FORWARD we II line tolerability expand are position that Today, of with Avastin, benefits its safety an in be combination Keytruda full mirvetuximab of into consistent platinum cohort Carboplatin favorable

more readouts the than Over demand from FORWARD the of we year, data reported the body in data data mirvetuximab course lay with in further who in this mirvetuximab's cohort. have at We multiple received or on recently, Keytruda Avastin culminating clinical mirvetuximab combination FDL will have from growing demand XXX we of will expanded this patients Keytruda. ovarian cancer. data believe II patients and combination escalation for dose More regimen of foundation XX support development presented in in use

lines four receiving resistant of of patients As XX% of therapy platinum with received these this with a have patients reminder, cancer. prior or lines. heavily ovarian a median are pretreated Patients prior cohort X.X more in

pleased all the response subset tolerability months in a study. two agents. Notably, of medium rate the receptor DOR These these the medium of of very enrolling This and we patients, patients of X.X of the week. in or overall was but folate overall of is show of receptor with level early combination and months duration now eight expression with high confirmed free FORWARD anti-tumor additional durable an based in or alpha X.X folate cohort expression and with response expansion patients was encouraging alpha data an XXX II just of profile on data, activity a confirmed median are or these For DOR XX.X and response with is and rate or survival the evidence are the high level, PSF XX progression responses a the patients, XX% we week. median XX.X with

saw the by treat to our mirvetuximab both particularly ovarian greatest we its the when with of folate and activity. subset of in of treatments expression other with with underscores as are in in earlier The and or the cancer high consistency care. We encouraged potential data is monotherapy patients lines combination alpha receptor findings medium

and we XX presenting be June. sharing this efficacy from as ahead, expansion safety the on forward plus maturing Avastin will in look more We mirvetuximab in details ASCO patients look in cohort we As at weeks a to over poster cohort data ahead.

plus expression. patients Earlier cohort, evaluating with recurrent this the Avastin and an study II alpha We of medium include ASMO expanded expansion also with FORWARD plan submit also report to an triplet for high in Keytruda combination to data to we presentation XX folate year will carboplatin the October, include in cohort, abstract from at which mirvetuximab patients initial disease. platinum-sensitive additional a receptor or expansion

we have relatively durability in combination. high initial triplet of the rate on this we will into carboplatin data would Given think plus response mirvetuximab observed and be responses, XXXX, before the it

tumor Beyond evaluate our Cancer other study, mirvetuximab Comprehensive in the National receptor triple Network Gynecologic are expressing mirvetuximab and alpha, internally several sponsored other sponsored there to cancer negative including the folate with investigator ongoing types malignancies. trials breast

study also Rubraca which evaluate with are in with co-sponsoring ovarian Clovis, We combination in mirvetuximab this cancer.

Phase finding from who reach and dose broader touch studies program. many our We possible briefly expect these the data as to IMGNXXX patients help development as evaluation. benefit IGN on in are I’ll I also treatment. of mirvetuximab IMGNXXX which both from may to guide

We the is to in other tumor just that IMGNXXX at But is in ADC terms a fit it CDXX, therefore there as for far IGN seen IGN's class to a toxicity. for demonstrated link, dose strand we ability normal as because they example, preclinically are higher, PVDs. any novel evaluation, refractory DNA dose The cells have easier an in DNA, window. active acting we agent of damage or therapeutic potential clinical which dose As reminder killing and and of repair developed. directed repeat one our are that our limiting cross cells we DNA a thus the AML. acting payloads better alkylate is assessing relapsed of and for not to

to are weekly dosing escalate our We and with continuing schedules. dose both biweekly

to at and an to for recommended dose, we a this for II December. get Phase year is goal Our ASH presentation plan to submit abstract this

plasmacytoid are we and we that an plus three with design. three We standard progressing developing CDXXX, escalation dose dose assessed IMGNXXX which also January BPDCN. the blastic ADC IMGNXXX. are station cell or is to addition and target a dendritic first In being in in AML IMGNXXX, call neoplasm,

PD, IMGNXXX We also the to for FORWARD are the II cancer. we first be have top whatever in ASH you expect the sharing activity both PK, complete of we coming line at the we’ll program enrollment I, the half With also an to progress encouraged are on and forward ASH. with and ovarian months. IMGNXXX you in with with next first data data in date have closing a safety updated data We’ll in very progress at this we which our additional to mirvetuximab would and with by In working FORWARD include in program look keeping planned year of December.

Now the to to to financials. over I’ll turn Dave, call our review over

Dave Johnston

Thanks, Anna.

were results highlights. detailed release, financial so just in morning's the I’ll this review Our press

charge the decommissioning X facility. costs Revenues financial quarter, of million. operate and our driven our related driven late-stage also quarter stage with $XX.X mervituximab, and quarter expense million largely quarter in supply on of the $X.X and discipline operating of equivalents. our than quarter focused which non-cash the used first remain Phase our program, R&D $XX drug and clinical ended again a payments milestone partners. million, with to by million along expense restructuring FORWARD trial increased and We million increase cash to approximately with We by resulted the to against and with in to expenses continue this our costs I bit portfolio release. related $XX.X first were as $XXX press for included Operating the our associated our cash mirvetuximab, trial were in less our $XX partners priorities lower XXXX IGN million to executing Operating reduction expenses this operations included in earlier R&D strategic the workforce in detailed related the Norwood in the in clinical of The research trial. a in were an from first cash clinical due

$XX remains million guidance million is we compensation out]. be between our $XXX about no to [phase $XXX updating for the cash million, which and million guidance. increase guidance the stock And and to of million, We’re a associated again which and we an million $XXX by $XXX year-end be lastly, previous for once year XXXX, million. between driven $XX at expenses change bit and revenues accelerated our expect Operating largely out $XX depreciation, unchanged expect year represents Norwood to with non-cash to

important of cash fourth with FORWARD operations will our XXXX, a We fund combined will milestones, us collaborators results. expect top-line through the and from including which expected into partners of that number current our cash revenues quarter take I

So, call let back me the now with Mark. over that to hand

Mark Enyedy

Thanks, looking milestones strong Dave. plan II. data of upcoming With a ASCO also for start from presentation highlighted program, Anna remainder forward to ASMO XXXX. the the meaningful we’re the year, including and both in of mirvetuximab our FORWARD at readouts number to a

to we the plan with X XXX at Beyond from December. report ASH XXX in mirvetuximab, data Phase and two studies

In ADC addition, the in internal continuing our strengthen partner position to are programs progress pipeline preclinical space. and our leadership

our We its TAK-XXX, in activities first expect quarter being and will ADC solid will into first that the our in with payloads toward indication. dose a using for directed collaboration initiate colorectal the the gastric with tumor ADAMX cancers. be year novel move GCC of this ADC This evaluated and to end IND-enabling program anticipate MacroGenics patient IGN a to Takeda

in Blaine years talent to roles at continue and pleased I worked were as ImmunoGen of and and also Business world our where during as add access together recently our transactional Genzyme role, company us the role from market announce moment instrumental Blaine to recently to Officer. to joins our as to XX and He management of We companies Blaine strategic, development of of be have and this he team last well brings has most evolution, over McKee XX the company’s for the Corporate functions lead fully in in integrated building In will experience. Shire a new successful transition extensive leading the years biotechnology various for corporate Head Development. appointment he we Shire served class this activities. experience, Chief in advancing

strength. launch the announced Arbuckle Stuart ontology Stuart’s will to Vertex and at Board as Amgen Directors. evolve sum, significantly a products. of international and the generally more appointment also contribute experience of We into and the commercial to mirvetuximab of position we our business marketing entered with from recently XXXX of In we

operational and plan multiple milestones Our track year. is lead data program with on readouts this

and near-term benefit Our we solid operating base. and a earlier-stage innovations look and to programs number of call anticipate We of portfolio the was remarks updated ImmunoGen. integrating I and the progress all in our seeing financial a a this year. exciting you With momentum accelerating are at prepared open latest forward keeping the productive our XXXX remainder in with from will another That questions. concludes throughout at we you year on catalyst of ASCO any for our now

Operator

sir. Thank question from Instructions]. with we take JPMorgan. And [Operator will our first Jessica you, Fye

Jessica Fye

Hey morning. guys, good

partnership Just talk to human say then with expect mirvetuximab of about a about talking with with Europe. a in in I mentioned to collaboration know questions, Clovis, data you’re you you couple see when the going a PARP we’re entertaining combination can potentially and

after point asset Thank want until partnering entertain this As you capture to more would prior or closer to you get still data wait you at they to value? you. would data, this

Anna Berkenblit

and the question second over Mark. Jess, take then Hi one turn the I’ll first to

an So, are will with cosponsoring and the we regular data the IFT basis. IFT University enrollment a terms they the being completion is providing This we they up us performed Ohio the are we Rubraca be to investigator on conduct investigators State Clovis, are the them. and since trial is study study that’s an of sponsor it's and in having to updates are and providing at mirvetuximab. providing timing of But an

Mark Enyedy

that mirvetuximab will I come mean which FORWARD Europe highest if is likelihood the question partnership predicate Hey we to were is value the from think from data partner Jeff. post readout right that your to I. I in

means we anything that interest, would do we’ve would the highest to from be the to value market of current of shareholders the that our need that were read as as it's we you we responsibility previously able and the vision inbound priority partner know which you may ourselves agree have enhance out I have partner to convince enable did discussed be to outcome us the post likely our perspective, subscribe monitor need with and So not if do time. to the and at the with data our to the program we that broad we it to would that partner would the that program the a things here

such into lung for example So, you indications know cancer. as expansion potential other

launch be tuned in stay our that supports So, to benchmarking and we’ve the those you I we would this European that, readout. entertain that in prepared product done would just know discussions said, market a say to likely exercise to ability post to be partner potential begin

Operator

would next And from David Huang we our Genuity. take question with Canaccord

Unidentified Analyst

Peter taking Thanks question. my this Hi is for [indiscernible].

mirvetuximab that Avastin quickly difference therapy ASCO you talk do ASCO just plus of at versus So patients Avastin the the prior of the data expect prior you in can about for most lines received have and data will at previously?

Anna Berkenblit

of with so XX pre-treated So, patients a just of a therapies data prior on cohort, be six less was prior it range In of the expansion five to previously presented we lines and up of to number two therapy, allowed will heavily population. median had the we they eight.

had who and In we mirvetuximab had patients addition, some some who prior didn’t.

presenting be the will we data ASCO at So, accordingly.

Operator

next will from with we take Blair. And Andy William our question Hsieh

Andy Hsieh

that prior make II Yeah what taking forward question. FORWARD sense Do FORWARD lines you the the first therapy, have I? what have Anna. guys the thanks you plus to done from for kind of had for mir with seen pembro. limit with I think on study Based is you going like number two, of

Anna Berkenblit

presenting as midst we for is us, So, certainly data in enrollment pembrolizumab now. now in we’ll the of at combination finishing option be an really that are and right

best decisions later could those the more around we see data that Certainly, mature, for in strategy on wait sense, may makes registration be to have combination. So, lines make will hand and further we the line other earlier data the just decide on based Andy. that how we’ll

Andy Hsieh

Thank great. Okay, you.

dosing, terms Takeda of foresee So, has severance of question? to secondarily Dave terms modeling do housekeeping in just question any one-time do the of in payment expect round with milestone, milestone another you payments starting you so second and do

Dave Johnston

that’ll that will shattering, it is, way. first be will quarters I it see a will milestone next going the a call. there disclosed the much not one, Yeah, yes be expect it's and small But, to to cash not that be answer earth it's how in it milestone be, we put

In terms of with severance, the down, you assuming. are am about I talking associated Norwood shut

Andy Hsieh

That’s correct.

Dave Johnston

quarters, the restructuring which a so, key won't but saw retention Yeah for enough a $X.X bit our first spread year, as large. that’ll quarter, be over be place it was are bulk in million will remaining in the payments other of the fee, but there be you over show the it like

Operator

take Wainwright. question from will Please next proceed. H.C. we our with Debjit And Chattopadhyay

Debjit Chattopadhyay

Well, questions. the taking thank you. Thanks for

CDXXX I And agent as process that well. CDXXX to So, have FLTX for think around a MDMX and with thought the development is expression that program, you equation that? now [FLT] for seems correlate a approved, the changing

Anna Berkenblit

Certainly, Debjit. but on are are tolerated as focused now this really year we we dose terms the combination, thinking identifying of right in ahead Hi maximum monotherapy.

As dose package in dosing to But this ASH support three we the the preclinical started data are escalation and design plus what from perspective always thinking presenting clinic. you need recall, may in about combinations we just in from January at a we’ll initial year. data three CDXXX be we

Debjit Chattopadhyay

precedent a that in asking early looks data Well CDXXX survival, CRi. the is is for set there's from FDA overall by an GlycoMimetics reason I but there is X, it not works, ask this point plus active it a the Phase peers, CR target, like with given because fairly some also end

in the relapsed you so the approval or survival it's wouldn't the then whereas in scenarios setting end combo of one, be induction refractory GM-XXXX based response does CR you more really FDA does a have to -- be plus it to do I CRi but case an because see was was could primarily on it overall that in trying still there, the point? know overall but effect CDXXX, tolerable rate, in the it an kind in the CR/CRi regimen So, in of the combos survival insist out and scenario, really make

Anna Berkenblit

focus our we is relapsed overall So, What options had in event-free around can pass on that the have typically the certainly been Debjit, registrational point end for setting. yet the point compound. line not first the the end be survival has for an the the and would approval say refractory appropriate setting on I occurred engaged there survival, what in ImmunoGen ODACs at regulators was CDXXX

We will our certainly pass through develop the proceed accordingly. follow the programs as trends regulatory clinic through, and

Debjit Chattopadhyay

combo, does program Okay, Keytruda champion there data the one mean expands, forward this Merck, with - that next this do in Merck, steering on final one, the you you internal then year great. the at is a Merck so of of often have the based and what’s meet collaboration I rather. step And much. in presented terms terms as How for assume fairly Thank committee SGO. committee an I with collaborator encouraging that you

Anna Berkenblit

broadly is collaboration of from the have diseases combining this up, potentially ASMO Merck that as that presented That in has format being should there interesting doublet SGO recall garner to other this are escalation the the agents in lung triplet probably arranged to certainly enthusiasm they with the drug-only Merck the have terms carboplatin data said data collaboration believe, continue that supply continued of and could for are even including other and hold quite may cancer. cohort we you as we opportunities triplet cohort a and options we’re expansion at at that drug-only. studies So, with one XXX-ish I and in

think if as So, the well. will all I’d that say hold I interest up, data the is

Mark Enyedy

as with to I We will the out Anna’s in in regularly this we review and report Yeah, to on Merck later the look just enrolment data, our at this good data quite to ASMO. continue expansion add do comments. the year we data encouraging complete share to perspective looks to and the it cohort and monitor study mean, it daily meet they

Operator

next from Jefferies. our [Operator Amin question we'll Instructions] with Biren take And

Biren Amin

X enrolled FORWARD first talk on and On baseline us Hi, guys, data you thanks guess, similar to know the that plan in the can characteristics is trial enrolled, readout you fully for half, I, about trial I just baseline? taking were I my in FORWARD questions. to if the the prior do the I with provide to Phase

Anna Berkenblit

we’ve Phase disclose population it to the we we’ve have go analysis. Phase Hi, medium data we prior that we X defined and not clear data have define I on we as disease, the from the lines said, III final and we as until enroll. key any defined monitoring the we who expression characteristics are will analysis enrolling or and we X three therapy baseline have platinum resistant study trial that plan very the anticipated eligibility of the been full do they high for been exactly alpha with characteristics where to pooled and top patients patients into receptor FORWARD demographic have from we'd line in Phase one we That the in been basically the being enrolled

Biren Amin

then Got now the you next you XX with FORWARD patients with for it on and bev, what data that steps this are combo combo? anticipate have do II,

Anna Berkenblit

compendia certainly trial. you combination disease, data continues Alternatively, in in an then resistant strategy another in patient couple to platinum to reimbursement chemotherapy since perspective, entertain Avastin be hold we US platinum and be resistant NCCN III would registration So, a and the viable US. from a guidelines can continue there Phase listing in to to are already it with up, if gather of would strategy proved a support know the options in and option is population

of have internally. we So, we’re couple that options considering a different

Biren Amin

steps? potential on FDA discussed next And have you with the

Anna Berkenblit

but at plan. of part that’s this our Not certainly point

Operator

we Cantor take from Mara next And Instructions]. our question with Goldstein will [Operator Fitzgerald.

Mara Goldstein

There differences if sort medium a pembro far between of those are is on the and to the I’m the for Thanks been high were in really and for the expressors I generated but folate know there high were the of why so expressors that’s responses thus mirvetuximab plus that had data for the that and question. you I question in some taking between subgroup medium and that terms that numbers medium rationale of small alpha. difference on see data wondering much observed? in would any patient cohort high expressors

Anna Berkenblit

Mara. you, Thank

So, patients the response dose subset in When eight in at was SGL that alpha medium and a high XX response patients escalation FR presented overall we XX rate we initial data the XX% with those from rate. was of at efficacy patients as or XX%. look expressions

So, of out five eight patients had a confirmed response.

number, the Given speculate in would I medium or the small not subgroup. on that difference high between

Mara Goldstein

I Thank timing Okay. just IFT around any cancer, And mirvetuximab there one those you. any data then some a with expectations triple-negative studies, for on believe in there were perspective? are from breast

Anna Berkenblit

these Again, share they us and it. have cancer tell when you they share is and know enrollment, trials breast enrolling so responsible data for I are what they the with data investigators investigator triple the negative are will sponsored is you can trial and

Operator

to presenters time. are this there questions further additional to turn call closing our I at appears back like it and for the no Okay remarks.

Mark Enyedy

Well, time everyone we on progress the remainder keeping your at Great. you seeing and you updated our ASCO year. today, of and look throughout Thanks. for the forward thanks

Operator

everyone ladies gentlemen today’s their for like to conference, that And participation. conclude does and thank

You disconnect. may now

Immunogen (IMGN) 4 May 182018 Q1 Earnings call transcript