IMGN - Earnings call transcript Q3 2017

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Operator

Good day and welcome to today’s ImmunoGen Conference Call covering operating and financial results for the Third Quarter 2017. Today’s call is being recorded. At this time, I would like to turn the conference over to Sarah Kiely, Director of Investor Relations for introductions. Please go ahead.

Sarah Kiely

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

including strengthen On have Pharmaceuticals the balance provide our an quarter, our lead as summary provide the guidance. updated strategic update financial Dave CEO, joining will on stage taken and the will our today our earlier of collaboration Officer, mirvetuximab will today Enyedy, are well Johnston, quarter Jazz the development including results programs, we cover as steps and key remotely CFO, to call with third is us Berkenblit, our our soravtansine, Medical Anna our Mark programs. a asset, events our sheet. for Chief and our

call Chief this also and then Q&A Rich open will of the our portion the the join call. Gregory, We will for team Officer Scientific for

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

Mark Enyedy

you, Good and morning, thank everyone you Thank Sarah. today. for joining us

direction value for business. fall, an strengthened multiple quarter company the set have we long-term creation. made we model excellent on progress both during financially to the new discuss quarter. we positioned pleased fronts to are third This you Last the business a We was with be operationally for for the the and as ImmunoGen and

our our our We become on with manage our defined a restructured value set we better programs prioritized and more strategy have priorities. efficient that to highest our focused clear of cash. and operations portfolio We

our launch ADCs XXXX, financial early continued innovation mirvetuximab the accelerate position strengthen in stage and First, strategic partnerships. through our extend in leadership and our position complete through development portfolio,

For progress and operational and a we these data a both trial set and reflect would with commercialization, material the financing, each performance development in that including to high fosters and execution culture priorities, development innovation. continued transaction clinical of to of respect support manufacturing accrual business developed cultivating business, generation, milestones that startup,

Over business the delivered the and we generated last XX have these towards on priorities. and months progress our material in momentum milestones strategic the made in significant process

on we monotherapy. the enrollment half X is activated Focusing I, primary and the are quarter, sites on study, middle the which over XXXX. of Phase third in of endpoint With in track have our this on to we readout mirvetuximab first XXXX for trial the FORWARD in the complete clinic, XX registration by

proof-of-concept mirvetuximab in Avastin cohorts We will FORWARD trial, as Keytruda have which the label mirvetuximab. also II for demonstrated and therapy a for advanced for with expansion have the provide foundation and clinical broader combination our a

In to a review Avastin environment, with our we address moving data following with with patients platinum-sensitive and addition, forward triple and mirvetuximab of a are combination of carboplatin last disease. quarter competitive

commercialization early cash, our formed development trial quarter. provides stage with enrollment global for to open combination the X IND will for in to and of $XXX our strengthens programs third May, collaboration over announced we late a million To our testing business. scale, through transactions of the pipeline proceeds this AML and XXX Jazz programs, and accelerated XXX end, the that basis these generates quarter. of us with least access one have with the The more heme-focused a financial in with the in to to stage financing for us have added the development broadly This XXX mid-September. later recent since a and us for of allows the XXX in at expected collaboration, position our for the funding that and events, and follow-on XXX at capital advance year. with Together these of of participate we funds the these including takes the with Turning give in through commercial number us we results in at capabilities, timeframe Sanofi and Phase important operating pivotal the least programs filing of strategic earlier mirvetuximab. the Debiopharm existing the trial run-rate, the partnership a Jazz which substantial X-year

in outstanding Additionally, to balance debt million our reducing sheet we just amount off of $X converted roughly the over $XX million.

execution. of financial So, quarters strong clinical, now we operational consecutive delivered and have four

carry through forward look over will XXXX. of the call will With the to turn pipeline Anna of performance year this our momentum review mirvetuximab and and I to a productive confidently end recent to with the XXX progress XXX. We level and that,

Anna Berkenblit

Thanks Mark.

approval. middle I During FORWARD the we patients to patients in of We this trial patients enrolling evaluating mirvetuximab ovarian in the year be the of with The FORWARD X quarter, trial our enrolled full XXXX. trial in third fully and is designed continued in enrolling began I, Phase cancer. by expect January support platinum-resistant to

has we Canada by are sites end Europe sites to track Our busy and opening clinical on and the have XXX more opened team been in U.S., of the than the year.

expect has Based thus is of setting. tolerability interim profile monotherapy and the and the in to XXXX. chemotherapy study the mirvetuximab an have for in we how on with the pleased platinum-resistant far, only have potential activity the anti-tumor as analysis mentioned displace believe progressing to are futility we quarter first We previously demonstrated

combination in of we our lead thus generated for expanding candidate. for further In have addition, the opportunity the in trial lines the II promising far treatment development FORWARD mirvetuximab data earlier positions

with that dose or doxorubicin pegylated demonstrated and doses Keytruda. safely full of liposomal Doxil full mirvetuximab combines Avastin, have We carboplatinum,

patients in combination we with cancer. cohorts and ASH hematologic parallel program, for IGN are annual clinical and malignancies a we ADCs highlighting for and IMGNXXX, novel data expansion In preclinical meeting, Avastin data are continuing preclinical mirvetuximab with that presentations to will have and upcoming are in currently enrolling which ovarian use triplet and At and combinations platinum advance DNA for We IMGNXXX. IMGNXXX planning alkylating Keytruda evaluating the sensitive carboplatinum recurrent our we Avastin our mirvetuximab with are IMGNXXX and payloads.

As evaluating XXX a in are targeted myeloid acute leukemia. ADC CDXX patients with novel a that is reminder, we

are week have every portion XXX regimen on and continuing an weekly for We Phase dose the escalation initiated other study patients ASH, ongoing in schedule present refractory will we to with dose At AML. CDXX we a recently clinical of positive escalate well. data relapsed dosing from X the as updated

and chemotherapeutic combination and using combination We The treatment human in will anti-leukemia AML of in of will preclinical the preclinical poster AML. the mechanism tolerability data vivo the for vitro also with present used commonly activity cytarabine, for a XXX models. describe

of cell anti-leukemia ASH, activity completed sharing and acute with preclinical details investigational announced to blastic hematologic now We and CDXXX IND including will we third at clinical at new patients lymphoblastic we neoplasm, testing ADC forward samples. month. the the targeted application we last to more active. drug the data XXX, Additionally, patient in XXX CDXXX With look cell quarter, positive These with novel lines and data meeting regard or to our plasmacytoid in is next present initial the FDA safety the are an encouraging that and review XXX, support dendritic BPDCN. month leukemia filed malignancies, very AML demonstrating during

of the significant X Phase to year. expect to we this study moving end In rapidly open clinic have progress. are and the the the compound clinical before We summary, made

Our on X track. is Phase trial mirvetuximab

the have we progress multiple through will of further to have end for have Phase We we the assessments and We before nicely sharing in XXX progressing second year. these X program, programs you. and entering novel look progress a a with combination mirvetuximab XXX clinical with development the program clinical forward third

to turn will Dave. Now, I it over

Dave Johnston

Thanks, Anna.

in release morning. issued some press our detail discussed in this were financials Our

the So, talk guidance review I our for XXXX. about highlights am updated going to and

million, with for of this executing We non-cash from continue the financial approximately remainder third includes development third were expenses focused is approximately of the on and revenue discipline the materials. balance strategic to our by quarter reflected of Revenues $X.X our in driven with our with quarter and which against operating being expenses the in clinical were R&D approximately $XX revenue G&A. support $XX royalty million and in operate million million XXXX, $X.X research priorities which

million taken. payment third Jazz and quarter from being we revenue that options in as the upfront the handled received Importantly, were deferred as is the will $XX be recognized

guidance We reported ImmunoGen cash our guidance with outstanding. quarter, non-cash end ended charge of of $XX with the of previous third about equivalents with collaboration convertible $XX third $XXX offering with With $X.XX $XX the $X for million of month the expect a $XX and net million third net million now quarter, approximately conversion from the public We cash $XXX loss the $XXX connection of are or million the cash million quarter and debt. included stock and which we a over million with updating million in million. compared For debt last million proceeds just Jazz in and of $XXX XXXX. year of between the between share, to our and just

$X to Our $XXX $XXX which million between guidance million to million unchanged revenue we $XXX guidance. and million and is $XXX is for expenses than expect expected be million between and be and lower previous operating

evaluating our to diligent available a meaningful ensure programs about advancing options have we We in have all continue funding adequate been to way.

added Sanofi fourth and last the million $XXX the with XXXX. Jazz, from X-year to over balance giving with As financing, X you of along sheet, transactions Mark, us quarter our into in runway have cash heard a our Debiopharm, our months,

to and stand development execute So as well bring these forward, And continue to financial mechanisms we on all with our that, we market. maintain to we to financed our strength today. very programs look evaluate

I back will call to over Mark. So that, with the turn

Mark Enyedy

course Thanks, by have a upcoming over number XXXX tremendous Dave. made look the progress of we to important am events. forward the and I encouraged of

Anderson will dose tolerability evaluating portion we data AML repeated the dosing presentations which poster prevalence of XXX looking CDXXX XXX XXX with in clinical combination have trial, data and from and updated XXX preclinical the ASH mechanism year, lymphoblastic effect anti-leukemia and of of the and of ALL the assays. collaboration and in mentioned, activity MD for leukemia Anna data of preclinical generated include the in acute As this expression at several escalation at cytarabine

anticipate plan the Phase XXX presenting Before AML combination, of Keytruda we dose to Meeting including XXXX, the and efficacy in Avastin at from Phase Keytruda finding Avastin planning for mirvetuximab cohorts then escalation FORWARD to Oncology March will and at also in are II half X the June. the Gynecologic the first and we of the submit from And data and BPDCN. data the look from Society X of cohorts. for to presentation expansion the additional forward trial we with ASCO ongoing we and trial data end the We open as report in year,

combination momentum with significant operational and in that, will therapy, potential execution is we all for ovarian as confidence with to strong look to year So, mirvetuximab’s accelerate study as clinical balance we our additional registration the programs, ImmunoGen. assessing an in advance for exciting data this And research will complete generated our XXXX with sustain cancer, with exit to generate and enrollment finance enter the time a a IGN these This call questions. efforts. sheet we open program, our

Operator

will to We Jefferies. with Instructions] Biren first [Operator go you. Amin with question our Thank

Biren Amin

points Yes, the Maybe follow-up in taking could additional additional patients? will abstract ASH, XXX data on the just hope start ASH, my get at to ASH we additional at patients for abstract see we and thanks on I if questions. what ASH

Anna Berkenblit

the will additional present any thus enrolled up patients from seeing the schedule, earlier X. at schedule we at from as presented levels at weekly on then, patients the that data Level dose Hi, of initial since schedule months, that have DLPs. without every well. EHA dose have past data have We opened ASH, in other few trial additional patients And been And year we all we over this a through Biren. far. week enrolled Yes,

Biren Amin

cause they then it do you Cycle And that just what then itself, abstract on was? was bilirubin trying in Can cycle, I the further any the efforts when occur, that? dose, was tell just the that of insights was cause the to died is hepatotoxin one us on unrelated. first patient correlation And of stated to X, there the did in the get think into occur those elevations, those there that

Anna Berkenblit

that’s have that deaths or risk related AML been infections. observed the and expected relapsed essentially is hepatotoxicity as with this patients about, drug. we and of pancytopenic have at infections. again, population are are VOD. infections, Biren. regard has closely common we to any drug With trial have for and patients to not elevated related to quite including attributed seen deaths is None refractory that some that in hepatotoxicity Again, something bilirubin, the we There monitoring vigilant in respiratory And been been that

Biren Amin

thank you. Great,

Operator

Okay.

next Michael Schmidt go to question will our with We with Leerink.

Michael Schmidt

had in progress in combo but guys. market sensitive was on And regarding of wondering the in the some one ovarian Hey, cancer resistant platinum-sensitive triple all fitting Congrats be I I overlap have the patients. obviously portion so inhibitors, the triple you quarter. in the third setting, just far will PARP combination study how the there market? inhibitors, just for with obviously the PARP see that you wondering into setting, the

Anna Berkenblit

Thank question. Great you.

effective difficult initially safety and And of So, of is that PARPs XXXX Avastin or monotherapy combine they of will do been from PARP for able part up combined combination preferred combination U.S. for effective, platinum-based far, profile be getting bevacizumab to dose approved with with the believe combine platinum-sensitive of all profile therapy. Mirvetuximab as and disease, different therapy. in in please out, far approved therapy anti-tumor really these as platinum-based activity. remember disease. particularly partner but point platinum-resistant platinum-sensitive everything been December have setting the disease. full who are the we that patients and PARPs maintenance. remember are in able before they because you to Also lined have because thus other mirve PARPs mirve In therefore for their benefit as them that of platinum-sensitive demonstrate activity of are tolerability that as recurrent maintenance, inhibitors recurrent we with our was not remember Thus our we were the only to agents have

Genentech setting chemotherapy supplemental filed for Avastin just and in platinum-sensitive first-line the carboplatinum ovarian plus So, for a in is cancer. recurrent approved the setting Roche NDA

triplet and So, future for platinum-based a that is Avastin. we with the mirvetuximab bright believe therapy

Michael Schmidt

the FORWARD combination efficacy thanks. looking studies? pivotal the year there and to with then next side go-forward for arms just And – Great, the on decision a Avastin additional Keytruda, in wondering are II you question what a make on for

Anna Berkenblit

So, activity we pre-treated population. for a have the combination, demonstrated Avastin remarkable very pretty heavily in already

with of of else that lines to bevacizumab everybody had a we had prior therapy, saw progression-free XX% remember may two only two-thirds least escalation prior had patients rate dose nice X the one and of months. You one at prior lines, survival around from four there response

consider in readout after the that there phase, the So, if even expansion those it And looking resurgence at might in data will hold be for there should be a setting. from also use bevacizumab development bevacizumab use out bevacizumab, up the platinum-sensitive in I patients in continued platinum-resistant of trial after of if platinum-resistant ovarian doublet mirve could turns in benefit we setting. positive, be the Avastin setting of that certainly pivotal months, mention the an coming the progression. to

see patients would response development further mirve a duration opportunities love Keytruda, So, the with three seen there benefit is them some rate, to minority in durable been that ovarian of do disease least in response. of from at and they have looked platinum-resistant seen we to to that ideally, that we as around XX% have is with have I a cancer it regard of With response response the but PD-Xs of mirvetuximab only monotherapy is a for doublet. think of about Avastin rate as a XX% XX% have at

the brake mirvetuximab directed reminder, seen soravtansine, activates payload based a As checkpoint activity should of you cells, priming on the the a a when anti-tumor systems release dendritic action activity enhance inhibitor. with that from and tubulin immune mechanism immune system the perspective, by its

will next be data year. those available again later So,

Operator

with take question Cowen. next from Boris Peaker we And our will

Boris Peaker

taking CDXXX year for on a questions. the differentiating middle how one targeting, in competition? mean the Right. likely My am curious BPDCN. competitive space Thanks I I and first see do next we become approved the drug is have it’s first my for just XXX from of you the

RichGregory

primary, which including wide Gregory a the treat aspects I Rich ability differentiate drug we is going demonstrated has of pre-clinically we And at meaning range actually least the have some therapeutic index, both AML. is to are in here. are this in Hi, in to but if think a CDXXX what of malignancies, line think referring much I they at positive have very less responses good impressive you you stem program, which had BPDCN, in particular look AML. to, And data

So, associated toxicity. to agent, particular think with we we conjugate a aspect anything actually toxin are to on are win the that’s of is safety near which going course leak syndrome, the this other believe that of and vascular level we the going of and have issue we don’t that is

broaden think I drug, range ends going both safer better to we positive us CDXXX speaking, spectrum, to broadly broader but therapeutic the potency treat on are allowing malignancies. the of of So index a

Boris Peaker

at Got it. of plan CDXXX, these specifically high shown a And have CDXXX in focused of to start also looking ALL you ALL? in relatively you an abstract on on with expression study Do expression indications.

Anna Berkenblit

initial and will Our AML. be in efforts BPDCN

established taken and safety X schedule, wherever expansion we build we profile. once we is already certainly steps Phase go in have as dose and once the malignancies, have a into understand and to expressed dose the heme CDXXX we would an to schedule quick be cohort. And However, that trial

Operator

we with Cantor And Mara next Fitzgerald. from take our question Goldstein will

Mara Goldstein

which in order the XX% as I fact? think responses figure am look you curious to to great Keytruda will durable to patients status at you is much be ask the this taking wanted indeed very only question. cancer literature discussion. able it’s a and not observable seeing the If just I are have you out if the just suggests Thank on not of I number patients, got you patients, ovarian for in Great. of efficacy you the think to ovarian the as to XX% to indicator population. about follow-up really a PD-X cancer of need

Anna Berkenblit

the rate So, XX% are quoting that to for is monotherapy. XX% you response PD-X

Mara Goldstein

Right.

Anna Berkenblit

is being trial been that disease cancer. but taxane platinum-resistant levering from Mara immune we But the out combination. a with in monotherapy PD-X I I X the would would be What positive, to enhance not payload pretty be response are developed the see it as think versus has in ADC of of proof-of-concept monotherapy the And combination, activation sighting hoping really cancer, really ovarian is certain turns these for our the our that system achieved directed Phase the and trial has not monotherapy to versus to if system’s avelumab immune ovarian be Doxil PDXs.

So, would would lines of in I potentially response for a way, and response by if and see rate expect in the that the form basis the durable approval. to a population platinum-resistant higher accelerated the more achieve we that do XX%

Mara Goldstein

Okay, thank of the out-licensing ask and around you. on coltuximab the that? And thoughts could update if an for for just timing I the potential

Mark Enyedy

mean, I tepid there frankly. the Yes. interest has been

which the And which Debiopharm, speak significantly conversation coltuximab, interest transfer competitive in CDXX the but given active so is so will interest generate is there more have the the as we in a we there. had we transaction is program, resulted million no there tech with say, as completing the tepid an and which interest the got milestone, timeframe completing predicted I but are for the relationship there, a We CDXX environment for limited. $X

Operator

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

Andy Hsieh

half, is you. efficacy, the half-life Thanks it a that for new observation, that stemmed my little optimize talk potentially bit weekly the for just am on maybe curious dosing about is Thank biological can maybe from XXX, question. I the decision? about you just taking

Anna Berkenblit

the on Sure, scheduling kinetics. very at actually the Andy. turnover the based the We receptor weekly CDXX beginning built trial of had

clear. the receptor this to has all toxic initial some CDXX time do hope make knew have other put safety and into was and into conservative have from really this antibody we a it payload along it we toxic that’s pharmacokinetics given anything profile therefore wasn’t drug initially a first weekly understood we once than schedule. every biology but our to that we the conjugate, potent of with really had been the move we started and new perspective our So, I with schedule PK of safety about the sure plans a patients, the more to week wanted

Operator

Okay.

our take with Newman John will We question next with Canaccord.

John Newman

am I Hi, perspective? guys. in for going Genetics Are things of a curious the the taking trial clinical know has really terms your differentiated questions. keep there for from study. the to my that as clean trial compound the have forward experience Good a morning. do that forward in that Thanks. you wondering but additional perspective am I Seattle are learned Thanks things mechanism, that if XXX possible? going can give safety next assurance can We as yourself just lot from plans you layers clinical that of there a you from

Anna Berkenblit

question, John. Great

two the then I signal was that that the is them there components the other caused saw think, are So X around the stop fatal trials one and here, really to infections early. they VOD Phase around

are it’s closely you monitoring So, effect around the a phenomenon, a patients for we VOD if not with investigators. following class target related perspective, closely LFTs will. it’s probably Again, working and more

closely. patients not example, transplant. not, are patients That have monitoring are who being restricting eligibility to said, a we for we had So,

patients We from a fine handful had and so that enrolled far who have have folks done transplant a perspective. have of

fight. a seen the for that longer puts low infections with on based excess sight the period on that infections, to to bad infection there. count white white and data, likely is based at happen So, that have learned risk the from more you patients fatal now your something low, imagine can’t excess of known longer are their in with time your one prolonged of immune that system regard and they count we but fatal their the do infection an terms I can’t a so right press think what to can vigilance of it had I With of myelosuppression haven’t an release,

on on their thing relapsed we leukemia, trial. then the important our their prior wiped coming patients treated and counts our developing into are on will we are first is as based us, relapse much are focused are the in the patients who we pretty but therapies for that refractory into marrows. in blood They monitoring line. So And out drug, move first with we continue right most and bone now,

should be we we seeing don’t which the if having to excess infections our that fatal So, carefully mechanism counts are blood monitor on shouldn’t as we based anticipate program in the our the prolonged progresses actions, program. myelosuppression, able and not of we

John Newman

Okay, great. Thank you.

Operator

It that speakers I to no this are or would appears there like the turn at back any today’s further questions closing conference to remarks. for time. additional

Mark Enyedy

for Well, to your Great. again in you joining today seeing interest us for thanks ImmunoGen at and forward we look ASH.

Operator

And this you does participation. Thank for call. conclude your today’s

now may You disconnect.

Immunogen (IMGN) 3 Nov 172017 Q3 Earnings call transcript