IMGN - Earnings call transcript Q2 2019

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Operator

Good day, and welcome to the ImmunoGen Second Quarter 2019 Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Courtney O'Konek

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

our today Accounting Berkenblit, Officer, Q&A. join team Medical the will and call President CEO; Foster, for Mark also are On Officer. our Dave Enyedy, and Anna Chief Chief our the

and highlight today's second results During we quarter recent will milestones. our progress, upcoming call, review financial

During materially Descriptions statements associated may risks the ImmunoGen use our and filings. forward-looking uncertainties SEC in discussion, we from will are actual results our included with and of differ an investment statements. in such the

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

Mark Enyedy

thank today. joining and you Thanks, for Courtney. morning, us Good everyone,

of business cash quarter, their milestones for with will prioritize portfolio During enable us we ImmunoGen the set strategic important a candidates, the of product position to phases half strong innovative number restructured fundamentally and second a objectives year at of second advance a look through with of that the these of next to to productive focused a forward development. programs the company. four We

partner safety mirvetuximab, platinum-resistant disease to mirvetuximab and to and Starting of combination with as we positive across FRα for chemotherapy preferred patients regimens of high single therapy. data benefit with in to-date, with agent has we've generated the displace multiple efficacy potential the believe the ovarian lines the cancer serve

settings, label into treatment studies. development a agent initial as of these objectives, single by through plan a we expansion platinum-resistant to the achieve are obtain lines combination comprehensive To pursuing earlier in approval followed

with are to design patient which we year. we the the study, end review registration of monotherapy, our and the before enrollment initiate expect of finalizing regulators For

share end will from FORWARD we data September. the ESMO the of during at an presentation oral full at addition, I In

ASCO presented the in will review data advance parallel, in combination In June, encouraging combination a we cohorts Anna our Avastin with moment. at from continue to which

combined mirvetuximab line will data We present and earlier initial also carboplatin with from our Avastin triplet in at ESMO patients.

in anticipate with Finally, of later enrollment recurrent quarter. regardless plus this completing platinum Avastin we in second status our ovarian patients cohorts cancer mirvetuximab

earlier our which significant developing under we've made our our anti-CDXXX AML to with stage ADC, and IMGNXXX, in we with progress Moving collaboration are Jazz. portfolio, BPDCN

this Over frontline relapsed/refractory we therapy. induction a in the protocol a last forward quarter, have determined move Phase program, minimal as well filed for dose patients recommended following as disease X to and combination have in with residual with new studies AML,

enroll our we BPDCN addition, will protocol. under to relapsed/refractory existing patients continue In

data from patients We will ASH December. at share both BPDCN AML and in

development to towards preclinical continue the being our year. needed into we well anti-folate to as transition receptor ADC the generation alpha MacroGenics novel with ADC Finally, co-developed completing ADAMX-targeting activity next as clinic, IMGCXXX, our advance next

and the So a of number year. a the the important significant with progress milestones of over portfolio remainder

our which we’ve the to results, issued financial this press morning. Turning release detailed in

expenses related in reduction a by charge year the Operating prior million million During patient million principally cash Kadcyla. accelerating $X to review, trial were approximately million driven workforce the conjunction $XX costs, our on payment of as expenses, by with $XX as the We in approximately the with a level in royalty and $XXX $XX.X revenue, ended $XX.X milestone with include we $X with million which quarter non-cash revenues these were related million were second from restructuring which in generated prior quarter, comprised Roche balance lower primarily in was for sheet. year. operational expenses, G&A clinical compared and in well compared million, in lower $XX decrease the to driven million the expenses I, personnel quarter expenses, R&D The same XXXX. $XX accrual when in million FORWARD the to

today. guidance financial our We're updating

at revenues For between million million $XX be million. $XXX our year, be and million and million, to cash $XXX $XXX expenses the to $XXX $XX be and we to our full expect year-end operating and between between million

Anna over more detail. pipeline in review I'll our to that, Anna? to the progress With turn call

Anna Berkenblit

Thanks Mark.

forward mirvetuximab I at the the to provide meeting with being anticipate first trials discuss monotherapy, ESMO. to announce Looking we FDA quarter at the we able this look regarding registration of full this to details additional and design FORWARD when data

track initiating plan We end this before the prior EMA Phase to we assistance are also seek trial the from of the year. on to which to X protocol do

combinations. Turning now to

in recently platinum-resistant patients at mentioned, in durable in as from profile, of data among the cancer. particularly with prior to with mature combination combination that to levels encouraging responses tolerability medium FRα up demonstrate cohorts favorable or chemotherapy expansion of and were data As favorably of therapy, to trial. anti-tumor mirvetuximab see our activity have patients alpha with announced expression, continues receptor to folate who We in AURELIA with Avastin a we this positive ovarian with lines II Avastin, this evaluating high ASCO the pleased compare received two FORWARD population

combination triplet earlier The on choice presented as a platinum-sensitive at as data patients study and mature Avastin cancer, of as doublet expansion supporting in support ASCO platinum-agnostic of that in up evaluating lines with with ovarian cohort quarter, agent the enrollment is this finishing We exploration the combination its therapy. the focused mirvetuximab mirvetuximab remain further in well establishing of disease. of use in carboplatin this ongoing

FORWARD II at look rate full with and forward safety along ESMO data I data. initial triplet response FORWARD presenting to September, in We

with on ADC payload. expansion cohorts IGN CDXXX-targeting our now IMGNXXX BPDCN. a our and hematological continued enrollment and focus the our Phase in stage patients is with studies the or for IMGNXXX quarter, refractory BPDCN. deploys most patient Moving X during this evaluated potent that early to is And portfolio, relapsed of AML AML in malignancies, being of treatment a

ASH the should to trial at of forward for venetoclax our data look be data with IMGNXXX from updated azacitidine with sharing monotherapy preclinical clinical abstracts accepted We or to ongoing presentation. IMGNXXX combining along

demonstrate development in additional with mid our We co-development IMGNXXX, is which anti-folate also advanced in enter to receptor ADC. which in is ADC and innovation XXXX. that continued alpha expected MacroGenics, generation next our two assets

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

Operator

you. Instructions]. Thank [Operator

comes Our the Newman of line Canaccord. ahead. first John go from from Please question

line open. Your is now

John Newman

two. Just had

split if see So we about medium that can just data analyses mirvetuximab give curious that the at talk than, and ESMO analyses see But of from the if other might of low? of a those us of are types some sense just high, we'll you obviously, you the can wondering embargoes. the between types obviously data

second have. ovarian you're cancer. wondering general about changes things to agency. of and what those just be But going the I meeting X And then bit Anna, And be? with so in about of second that Phase the to in you you obviously could could some speak tweaks can a make some the Thanks. little question talked if previously, the you

Anna Berkenblit

Sure, John.

the will So the protocol the that include and primary the I color reported. And for top-line we've analyses specified. were study already data that now key secondary that will ESMO FORWARD present to that at we endpoints add will

be next addition, analyses that to understand trial done the we've some as the are well. analyses And design In trial further of exploratory population. the shared X and those informing will Phase the exploratory

John Newman

the key -- key what remind the were? just you secondary and Can primary

Anna Berkenblit

Yes.

for And response key blinded endpoint overall primary independent I included overall endpoints the survival secondary FORWARD review. and key survival. the was rate So progression-free by

John Newman

The other question was around tweaks?

Anna Berkenblit

Right. Oh!

that Clearly, of priors. with the we designing we on will Phase FORWARD I design I we’re in much based in tweaks FRα of analyses same next process the analyses. X consistent to finalizing the the done strong, on from of that be will additional the it study. X on of we because signal trial. terms that saw anticipate be We the and exploratory platinum-resistant we've So will high The was, the efficacy patients be where the where focus FORWARD X that's will

Operator

next Peaker from from Boris the line comes The Please ahead. go Cowen. question of

John Scott

questions. is Scott you This for our taking Boris. for Thank John on

lower anticipate would strategy anticipate maintain positive all if any high priority you're may First, secondary do FR update on competitions? the I process? looking for combinations on mirvetuximab high? study, previously, label if assets. you broad indicated more you based has the a be for limited that to wanted you for new Or a for then population know there's monetize you And pursuing Thanks. that do ahead some those also FR

Mark Enyedy

Sure.

kinds that In play-by-play. conversations terms you'll appreciate of amenable are to generally of not those business development,

an now, we're And a clear Right of high provide it's looking the to and parties, to interest, expression. next to studies, with we're the and label. accruing outreach a terms speed. level multiple inbound path process levels pursuing with monotherapy delivered for So with in beyond patients combination medium those active that cohorts one of us we're continuing with in all conversations those both will evaluate

have we tag. and which registration determined so, up terms the both I XX% time overall include being say to running roughly a what population. cohorts And medium be of the that in would But for the and patients, are high is of

Operator

from Kennen next The question MacKay RBC of from Capital comes the line Markets.

Kennen MacKay

wondering if you trial hasn't moving could the the solidified that letters much. are on was the Anything little the potential in more of bit Thanks trial next of been this cost talk free about I yet? the maybe completely costs what remaining the sort trial a parts the FORWARD design? or needle sort move the that in FORWARD for of still of there additional estimates so the of and terms could

Mark Enyedy

with the that costs, Yes. vendors, various the disclosed previously in who go support total trial we have RFP trial not process working that Kennen, appreciate sort on an of basis. of forward and a through you'll might we're

sizing will backdrop, data about have study focusing what on we the the impact expectations to on from we patients. we high then study, say And hazard And for I FORWARD reflect and as be used for assumptions in think this will I a so, ratio have. exclusively this adjusting the that I that mean that's some would with that we what

it. costs. comment not things to those position this But on point, two into the in we're will So, factor a at just

Operator

We'll from Blair. sir. take Please from the ahead, next William go Andy Hsieh question

Andy Hsieh

two. have I

I in perspective, they obviously scenario of FORWARD positive that terms study? willing of assume do would review very you study, intrigued impact setting. terms the a in designing also EMA, about ongoing are And I how estimate MRD this an that, in the AML just With new consolidated indeed, the duration? have would population So, to analysis if from effort

Mark Enyedy

Sure.

Anna, so. topic let is it -- some and importance well I’ll So

Anna Berkenblit

Sure.

therapy, but you do get residual minimal So example, disease and frontline we're the cohort detectable for excited patients monotherapy. wind they know, then as flow do positive don't who intensive having extensively still by up about very really well. is well, cytometry, Because for MRD IMGNXXX

is there safety less And profile heavily trial. like understand for a of pretreated of signal ours so, way well-tolerated our a and potential the Phase efficacy us in further the enrolled this be benefit patients a in currently being would monotherapy than drug to really get And it population. our for to are X

with meet next mirvetuximab. to European plan do regulators Phase we trial fall EMA, X the the of assistance protocol a the this regarding terms In for for

Andy Hsieh

Okay.

So in occur terms of ESMO? or timing, before would after that

Anna Berkenblit

After.

Operator

next Chattopadhyay Wainwright. question Debjit The H.C. comes from from

Aaron Welch

Debjit is This Chattopadhyay. for on Aaron Welch

just I ask ImmunoGen XXX. to want about So

indicate determine X the you would you the dosing be? would Now recommended that disclose you presumably dose Phase what that schedule, be able to and

Anna Berkenblit

there have ASH QX schedules two a Yes, weekly that And at and so sharing schedule, so be from are -- look we abstract then to is week forward which schedules a should we our accepted. right, explored, data both schedule.

Aaron Welch

And the to interest you I from would the have next but there interest? in anything lot a able strong -- mirvetuximab tell first did you Phase X trial great. what Okay, Again, study, physicians heard? so, of you for indicating was be know heard for us

Anna Berkenblit

Absolutely. Yes.

need, enthusiasm overwhelming look lot agents this cancer where ovarian And We physicians that at for X patients. And heard platinum-resistant access even that trial not to at their is is for if trial, have in to support this are are the approved, next in be of that point PARPs get drugs really when their and only a disease. because are pipeline able This there greatest at the being has explored a way will the the other mirvetuximab not platinum-resistant and clinical unmet show you Phase look high you landscape. benefit. the

they're and to is execute enthusiasm this well want with with Phase patients them trial. on for the quickly high. working So forward X are drug us to looking and as the we next Investigators really their

Operator

go Please We'll the Morgan. next Jessica JP take question from from Fye ahead.

Unidentified Analyst

going you this XXX, steps to X Jessica. for as is trial our to for a this next Vidaza an do Phase studies? question. conduct add-on Daniel venetoclax or to think or the arm we taking Thanks Hi, single for randomized about plan When be is

Anna Berkenblit

a a need first, walk It's it. safety in to Well, very first Venetoclax escalation combinations thing do doses regimen. not effective study demonstrate azacitidine adverse There that a is to of are dose we plus the associated are the the some combinable. and basically with events park.

involved identify would move time as proceed forward. combination thoughtfully the soon quickly as we say a to the would we be be. And can randomized to development can, we that the certainly as too we just It's when trial in as So will then would plan. appropriate

Unidentified Analyst

focus BPDCN If I develop forward AML. going as seems well? that can still towards be intend ask one the Do -- future the it for more. It you to will will be

Anna Berkenblit

Absolutely.

We to efficacy look initial from we patients continue to small forward activity. BPDCN. to promising we encouraging have last And we we shared very those say ASH. see I'm an ongoing again, monotherapy at patients in and year. data ASH a number cohort additional that glad of at have enrolled sharing data And

Operator

Biren question take a now Please from Amin ahead. go Jeffries. from We'll

Biren Amin

Can I are what setting? with combo? that you combo. looked What are the forward triplet know going the you've your platinum-sensitive mirv plans share at your plans in

Anna Berkenblit

Sure.

the it to to So the partner aim and based displace we mirvetuximab, combination on for of choice chemotherapy. tolerability be of profile

patients Towards And in we mirvetuximab ESMO. look aggressively sharing the was bevacizumab Phase platinum-sensitive and therapy. X data us and combination quite led that explore from data the carboplatin platinum-based end, response cohort doublet of explored initial we to that and to forward which at carboplatin therefore, initial disease, rate get triplet favorable, that

patients. out most then We to carboplatin be further and the triplet. the for that with for now, we're makes sense basically two continued would doublet options thinking with for really therapy really development right And or have through mirvetuximab the a figure options what development

Biren Amin

of When And terms alignment. with then that the from in is the study? know trial on can that we combination PARP, expect the data I maybe

Anna Berkenblit

Yes.

So at you're David co-sponsored investigator-sponsored referring looking trial as with rucaparib mirvetuximab and to the Clovis. State from flowback at it's O'Malley with with Ohio

from to. It So to data ready it's enroll when share they're an in and their ISP, they it's will continues hands. it

Operator

Chang from Instructions]. SVB We'll [Operator Jonathan go Please next ahead, question from take sir. the Leerink.

Jonathan Chang

Hi guys, thanks questions. for taking my

mature you data the sense a us at how will of can First give ESMO? question be FORWARD I

Anna Berkenblit

you which data analysis. ESMO pre-specified progression-free analysis see will protocol-based At the from survival final our was

also see survival will overall You updated data.

You somewhere the survival cancer was with may range. XX and overall XX platinum-resistant recall that median between patients months for ovarian the

a first finished enrollment, quarter on And overall that of sense mature be having perspective. based the so, how year, us up will from you an last data survival gives

Jonathan Chang

second IMGCXXX half the And still on just for second filing question, year? IND track is for the of the

Mark Enyedy

the our the the night with lion’s in So the operational the And to in MacroGenics. are conjunction restructuring, talk is will IND in we in spoke go-in And their to like. share up of work of a in to the transition process this Scott of I’ve get for responsibility that the the point, of there, through. transferring guidance position IND with last support just for to a to to first way need fair XXXX IND and this a amount particular team and speed would account we the in clinical that half at

Operator

Please Schmidt question go ahead. comes Partners. from Michael last Guggenheim from Our

Michael Schmidt

I sense potential have questions. I my patients had many if XXX. had a taking recommended and Phase Maybe us question having give level for of just the just good identified confidence the on at how as your will you could a dose. X ASH actually regarding treated thanks Phase dose? of update guys, a Hey, a X been couple

at various think you've very at doses. year, seen including low ASH I activity doses, the last presentation

of dose? sort identified having confidence in So just curious, your I'm level the right

could Thank last after think just areas same about then touch was, antibodies are differentiation on from some question the And bispecific on that the you. of if potential you the XXX of target? you how going

Anna Berkenblit

Sure.

give levels X dose We last have that safety at be now explored So XX the had it we multiple additional across think several us activity we when just we the dose you they'll levels. data We year, in Phase of can across where levels and worth recall already recommended that probably dose. confidence dose data but saw not for that. ASH presented ASH you around may at patients efficacy see

the with release drug It relatively differentiation to see every short cytokine can weeks that Moving is that given the assuming be an is of not with bispecifics. the outpatient enough. three once have as of you patient things risk can the bispecifics, did infusion type well the our

data doses, looking safety tolerated, that But a very So has quite better could potentially, a convenience that. over it's profile, head-to-head at profile. range comparing and we our that appreciating patients a feel well There's again, up safety no of much. factor wind

Michael Schmidt

earlier of may And you phases? then what in to with maybe degree of one us these opportunity Jazz as Vyxeos? to sort combine follow-up. just this can I is guess, And there be an remind development involved

Mark Enyedy

So we this relationship. highly a collaborative -- is

a contract quarterly more basis. a committees team meet formal But engaged is that regular have basis. on on much we So the

our physicians So Faderl is out probably at MD side. Stefan came lead you of ImmunoGen know their and here on Anderson, who

colleagues the Anderson, two were speak regularly. at MD of So and them

highly And collaborative. so it's

with forward, the development to specific just contractual think maximize as the would we with program an But we benefit we're this Vyxeos of the So those there potential through collaborative move them. control active lockstep a that's combine from is approach. it's where standpoint. in And it's the conversation. I But and again, a two ImmunoGen together. indication agents sorting does

Operator

now remarks. questions there any to or call like back additional Enyedy turn for no time. at appears to closing It this Mark further the are I'd

Mark Enyedy

Thank you.

morning. And ESMO Thanks. of at much joining very we at forward to on you summer us So September. everyone end appreciate the will a Friday seeing all look

Operator

this participation. gentlemen, call. Thank concludes and your for today's Ladies you

now disconnect. may You

Immunogen (IMGN) 2 Aug 192019 Q2 Earnings call transcript