Earnings call transcript Q3 2022

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Operator

Good afternoon.

We will begin the MacroGenics 2022 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. [Operator Instructions]

At this point, I will turn the call over to Jim Karrels, Senior Vice President, Chief Financial Officer of MacroGenics.

Jim Karrels

Thank you, operator. to financial Call and welcome third discuss and XXXX quarter operational afternoon, MacroGenics to Conference our Good results.

outlining press For chance anyone tab this on a at the to the which afternoon release review these our available who's results, we Investors not under today's announcements, had macrogenics.com. is website issued

listen approximately conference it call also archived for X be is will after XX webcast call on may You beginning via to this days hours the where our website, completed.

a listeners result alert the various including results the Private to Factors safe discussed filed factors, may like Risk today's plans discussion of prospects about in materially would those SEC. the I under forward-looking Securities the statements Actual include that Act reports of and indicated current of purposes differ quarterly company's and as our by with the will annual, Reform harbor provision of expectations, section those important future XXXX. Litigation statements that statements constitute from these forward-looking for

In our forward-looking not as today upon of be any relied views and representing our addition, only statements as date. should of subsequent any views as represent

While we at we point do law. applicable statements disclaim these may update future, except to our the so extent to any obligation if views required by forward-looking specifically even in change, some the elect to

and of MacroGenics. And now I Scott would like to turn CEO Dr. Koenig, the call over President to

Dr. Scott Koenig

webcast today. our Gilead. programs I with I'd to clinical recently via afternoon, like call welcome This Jim. collaboration you, and provide participating announced Thank as on key everyone will well as our updates conference

will call review the first who do our Jim, But so, before I me to turn let financial results. back

Jim Karrels

results XXXX, recent highlight This position well our which September quarter our Scott. ended the afternoon, for Thank as MacroGenics financial as reported progress. financial you, XX,

XX, the XX, XXXX. primarily revenue September from for quarter of $XX.X September of As MacroGenics million described agreements revenue million $XX.X the our afternoon, collaborative ended quarter compared revenue for to XXXX, was release consisting total ended this in total

they us Revenue for payments included XXXX. from licensed Incyte $XX the September retifanlimab, related in XX, XXXX, million in quarter ended milestone which from to

ended MARGENZA for quarter $X.X included also quarter XX, million sales the $X.X Revenue compared September of XXXX, to for XXXX. the ended million XX, September net

development XXXX, quarter to $XX.X for $XX.X decreased the research for million compared and to million and manufacturing decrease quarter to related XX, costs XX, ended Incyte, XXXX. September for ended were discontinued studies. expenses the decreased Our was primarily costs related retifanlimab The September

increased clinical preclinical MGCXXX, MGDXXX. related development, decreases related These expenses clinical increased to expenses manufacturing trial by to molecules increased and lorigerlimab related were and projects discovery offset costs and partially and to

Our selling, XX, general quarter and administrative costs well million primarily to related expenses The million the $XX.X decrease September September expenses. consulting decreased as for the MARGENZA XXXX, compared ended XXXX. as was for were to decreased $XX.X quarter selling XX, ended

quarter for Our for loss the September million was $XX.X net a of million XXXX, XX, XX, ended the ended September compared XXXX. loss to $XX.X net quarter

not did October of December balance to Our equivalents $XX was The balance as from cash, of securities compared subsequently XXXX. XXXX, and Gilead million $XXX.X million received XXXX. XX, include September as September $XXX.X in XX, cash XX, marketable million XXXX

of TAMARACK the as our cash runway cash from MGCXXX corporate updated mid-XXXX. extend II related as MacroGenics anticipated received product Finally, revenues our of anticipated portion planned that the to well as September should cash This XX, of balance we and cash, equivalents anticipated million guidance reflects restructuring our marketable $XX other and partners, from runway, in payments anticipate terms our securities plan, study the Phase announced into subsequently XXXX, Gilead, savings cash well as previously from ongoing runway as projected expenditures studies.

XX us with days potential which of In Bio milestone addition, within would obligate Provention BLA runway. achieve cash would to $XX we the of this later approval month, a approval that note help provide us that million teplizumab X-year the a

I'll And back the turn Scott. to call now

Dr. Scott Koenig

our few in to Jim. payment milestone receipt $XX Incyte we and you, the us payments Gilead. past from months, from generate million which via the In the demonstrated to ability nondilutive capital subsequent $XX efforts, collect million of Thank partnering upfront enabled

We are Also, cancer in should continue the very new collaboration we which the patient our study by to advance be excited in believe to first in operationalize dose name with MGDXXX we to vobramitamabduocarmazine TAMARACK a MGCXXX, study able of year-end. prostate Gilead. has and

the in clinical in we lorigerlimab, completed forward enrollment of with study first look data to expansion of monotherapy sharing Finally, quarter dose XXXX.

clinical a updates DNA-alkylating designed expressing investigational molecules With through payload on duocarmycin starting our let or that portfolio you or BX-HX. vobramitamabduocarmazine to cytotoxic me with of MGCXXX, ADC backdrop, walk deliver to tumors

family BX-HX is types. duocarmazi, of member multiple regulation. involved designed advantage to molecules broad the expression of antigen's was BX Vobramitamab, across tumor this immune of in a solid take

year-end Phase the study. with data operationalize We interim TAMARACK anticipation TAMARACK of to study make sites the continue expect from to begun of II the as in We've XXXX. start the progress we initiating by and study portion clinical

me update lorigerlimab. on let Next, you

to including vobramitamabduocarmazine continue pancreatic lorigerlimab study cell escalation patients dose renal in with We in I carcinoma, with ovarian cancer, cancer, dose and Phase carcinoma, combination advanced of mCRPC patocellular the patients melanoma. solid tumors,

with incremental vobramitamabduocarmazine, recall You enhanced agent anti-PD-X combination toxicities. an be preclinical significant therapy without on may antitumor data based may from that with studies, our by activity

Phase cancer. microsatellite enrollment the in we cell monotherapy lung with I/II During cancer, of checkpoint-naive non-small the colorectal as and second stable melanoma study expansion mCRPC, lorigerlimab patients dose completed of cohorts quarter, with

we're by will look mention are so clinical to you far. still data XXXX. sharing seen very we We study. XXXX, wait first a we've study while patients on forward to Many update with provide this And early what I'll the of encouraged in in on that quarter

CDX MGDXXX half-life. DART molecule dosing to while through and CDXXX designed a activity up, that permitting next-generation x cytokine-release cytolytic bispecific longer is the component anti-tumor maintaining our CDX incorporates Next syndrome, minimize intermittent

leukemia study CDXXX-positive and Our myeloid hematologic Phase ongoing acute escalation refractory syndromes. with MGDXXX myelodysplastic including of I dose or patients is in relapsed malignancies,

oncology. month, exclusive option thrilled an a Gilead we're programs course, and to MGDOXX. as Last with agreement entered and up collaboration MGDXXX additional bispecific advance to develop in to Of have Gilead we X research partner to collaboration

the grants options option the had license exclusive to MGDOXX. still Gilead an The agreement to

part the paid be of fees in Gilead upfront to up development option will and eligible $X.X commercial million payment target As receive nomination, regulatory an of billion and us MacroGenics and to agreement, milestones. $XX

programs. MacroGenics from flat will resulting net MGDOXX, net double-digit also sales X a worldwide be on to of additional receive royalties tiered and worldwide on eligible sales products of research the royalty

program across MacroGenics include an The will to expansion exercise segment Phase and I be Phase segment as decision predefined Gilead of study license combination and evaluate dose has ongoing elect escalation intended I with that indications. and to the option to other MGDXXX, for responsible multiple at points. the will a been therapies monotherapy study MGDXXX may his in

Next, I being rights. candidates will economic update our our an developed by partners collaboration on certain retain provide for we product which

mentioned an for await is on XXXX. and acquired of decision teplizumab, the under the both purchase prevention monoclonal us we agreement from earlier, Jim diabetes. Type Provention developing in that FDA's antibody and anti-CDX Provention teplizumab treatment Provention As an asset X

the receive U.S. to XX, inclusive is million, of in $XXX extended indication if The milestone. sales prevention target million on milestone for to royalties the of addition PDUFA is action November of approved, teplizumab, Type net eligible $XX XXXX. that MacroGenics approval diabetes payments X totaled date

$XX addition to Corporation. sales net Retifanlimab receive milestone in to Incyte MacroGenics royalties studies. of is is received combination part on its agents Retifanlimab agreement. multiple milestone if currently eligible an other across payments. as payments million investigational monotherapy of from exclusively in we MacroGenics being as approved, in XXXX, with collaboration Incyte studied In anti-PD-X is or retifanlimab, licensed to mAb that July

in previously the of XX% goal facilities restructuring existing which a our closure anticipated with of we our of reminder, the included Finally, of as resources. workforce plan, August delivering product value-creating with a financial and announced plant our and pipeline candidates, X reduction data prioritization

All of to measures saving cost according proceeding plan. are these

committed remain progress patients. to our open through life-changing now the would questions. and for delivering medicines With Operator? We cancer continued to to developing XXXX, happy be call we

Operator

[Operator Evercore. Miller from John at Instructions] question first The comes

Jessica Hui

guidance Jessica are mid-XXXX John. Hui those and that runway. cash questions future included from partners is X My the part in is, and and question to the Gilead. runway you mentioned gets product payments what from of for upfront exactly besides payment million PR projected anticipated from on the is The revenues, me. $X This cash anticipated first

what Can already that lead and something? us these the of at to 'XX For runway for of what cash an expecting or in you're XQ the from data extend to you that that example, update payment idea the include least million XXXX? payments their Bio further milestone potential give baked in is can $XX milestones end PD-X/CTLA-X can that Provention

on a little at And may give to elect I entail? question is decision it license points. a one Gilead that us you also their to Phase PR would data mentioned then [clock] my color exercise have fair option this choice? is say to Gilead Can decision program these more these the clinical points of what predefined be on second the points. the bit Does Like that

Operator

Instructions] next Securities. Jonathan [Operator Chang question Our of comes SVB from

Jonathan Chang

partnership. regarding First pipeline your thoughts development to business curious the Gilead other deal? recent this I'm hear on question, post congrats broadly on assets

Operator

Our next question SMBC. comes from David Dai with

David Dai

SITC. us testing you One if trial? want also maybe combo MGCXXX. lorigerlimab? presenting question to understand I MGCXXX recent rationale biological at will the little Could more also say be understand congratulations data the this of be a talk I combining the will in that on on about you help terms you progress. my and you a dedicated Could

Operator

Yes.

So issues when your brought the question. hearing to all reason, for of to the we're some with having you've participants been you on call, answer ask our

issue. same that having not are We

if So we're see this. going we [Technical to second resolve work a to can just for Difficulty]

Dr. Scott Koenig

a additional far rationale we an mechanistically to the Just orthogonal have blockade gives your is response killing Difficulty] in against And targets. PD-X that lorigerlimab with MGCXXX you of darpispecificlorigerlimab, that a mechanisms where immune combining given enhanced blockade. now responses, with behind ADC [Technical that identified combining and we've so seen question, the the enhanced success the had give the

Jim Karrels

Operator, need turn you off. to

Dr. Scott Koenig

Yes.

on rationale is additional monotherapy using is now had we instead the encouraging seen. retifanlimab, instead bispecific the but already of the data based So using of just

as was activity. idea blockade the as both checkpoint So to well ADC optimize the

the that's rationale. So

Jim Karrels

back... go Maybe

Dr. Scott Koenig

Yes.

BD regard me ongoing fronts, clinical the been Gilead, Jonathan's preclinical question, Jonathan, with activity, and portfolio. assets. discussions we in our have have in to preclinical back addition both partnership to on very recent on continuous of the as for number to pleased with BD well we assets a on both clinical engagement Let I'm the are aware, go of many and And many, success say, you years active to

nothing have to but year, at discussed. being you I the this of So we activity more time course as additional the point, should anticipate have on over goes describe could

Operator

you the Jonathan, to would And question. like live follow-up on are stage, a you if ask

Jessica Hui

to elect back license exercise their just question, I decision to the in us Jessica. give more in got Gilead I predefined line. guess, second you the Could is some may to points program. option color that? This the which my on

Dr. Scott Koenig

because -- this Jessica, answer agreement, where just period. the of tried nature a into was period Gilead Jim not the allowed that to during but option license specifically take we're question, me to points enter the of So the define can there reiterate, to nothing let option

Having do said that, can any at time. it they

will dose to So escalation. be there's additional as And clinical then going clearly, studies plans the continuing on the results today, combination they monitor to described forward. do we

So this in. molecule of opt they time at any the during can examination

Operator

next Guggenheim Zhu Charles is Our question from Partners. coming with

Charles Zhu

if... Difficulty]. wondering [Technical was I

Jim Karrels

Difficulty]. it you've line. [Technical that dropped not Operator, sounds like

Charles Zhu

been year Could ongoing line weekly progress this lorigerlimab? the XXXX some MGCXXX in of you And was the well? your the provide provide combination into dose combination I more that as has with some early lorigerlimab newer update if escalation of QX dosing. sight potentially I study wondering the the think lower since with earlier color study could into

Dr. Scott Koenig

the mg at per of mg in reasonable dose a Charles, The Yes, this, lorigerlimab per specifying things, that kg, a a component view with the the X reasonably taken would I we timing where of we continues. set to and at kg. without -- aggressive fashion plan was again, had starting say, escalate of obviously, dose the X MGCXXX

escalation, even low dose of see to MGCXXX. clinical As you we our doses responses from recall began at

particular to when of do And we expansion we particular time given any profile see might the results, to cohort. occur timing that escalate safety any be at some able obviously, of rapidly, with to they dose fairly doing can we at of to appropriately. that our plan So combination the regard attention may elect to clinical paying and time, is that believe,

occur, will it's in to too So at early but of that early time just when this 'XX part in the occur could say 'XX. even

Charles Zhu

And on follow-up, maybe you one update, if XXXX. program the mind, specifically don't lorigerlimab in

but lorigerlimab you soon if we SITC that bispecific recently may for not seen was emerging contextualize wondering So relative some looking upcoming update help others see sure. the forward us that PD-X/CTLXX to And well? that conference only the other could to I also also at the of one we've as data some very

Dr. Scott Koenig

Yes.

data we as the cohorts, enrollment we noted in encouraged plans. been have our today, expansion X we've So by the completed

one We will or several many quite of of in these in considerable. more -- these expansion discuss cohorts, cases which are

that, that of potentially forward doing at in Given one we're we're be more we've as indications will these to already looking and in plans move early XXXX. in potentially or studies, combination noted all monotherapy studies discussed also

So we I and compares I should have those all have and also comparisons quite tested. can PD-X/CTLA-X favorably of molecules, that to state the note our that that many made done type competitor molecule we've

Operator

from coming Lucas [ph] Our Markets. with Shumway question next BMO Capital is

Unidentified Analyst

comparison? what views question, -- what's expect are development on for are development XXX? what business What and The tebotelimab? like thinking saw Do for your the for we questions could latest a you clinical on for is the benchmarks on [study]. opportunity actions looking we cancer with MGCXXX think And you second to you a similar are prostate evolving your

Dr. Scott Koenig

regard in to prioritized prostate with II/III on well the was cancer operationalize with Phase targeting had clearly, androgen-receptor agent. patients as study to progressed this castration-resistant who MGCXXX, we've chemotherapy, So one stated as, year as quite planned

we noted the that the to major patient in in occurring the end this looking today, in enrollment of of 'XX the by year, plan the we would part As population. first be at have

now. the And study just prostate in as into based data of additional that of on with the the major combination course, we doing MGCXXX And other so that we're and that's discussed, results of and lorigerlimab could right focus lead then, indications cancer. opportunities

we've we've our is With regard programmatic to the been as tebotelimab, question noted that concerning spend. prioritizing

in We date, very well on reported tumors data therapy. CAR-T have, DLBCL both obviously, in as post exciting that solid to as we've

most regarding studies, solid partnerships. in we nothing those with are discussions to the as of a partnerships would we've well discussions, tumor setting particular hematological think magnitude again, of and But promising are or additional now. capital We a malignancies. looking spent have more those lot to ongoing be time regard that future opportunities for I identifying in report as in And

Operator

next question Our Silvan Instructions] [Operator from comes Tuerkcan.

Silvan Tuerkcan

in in questions regarding, this progress, approval the discussions I are the coming and announced have Provention quick X teplizumab there. labeling that morning soon Bio they're they November? How confident you

about do great. do royalties royalty then when meaningful commercial think will if MARGENZA considering your think that the could be when And to you talking -- opportunity sales, you answer here, you you be would

Dr. Scott Koenig

very With Provention announcement their obviously have with encouraged than along public publicly. sense weren't post-marketing PDUFA putting the know regard been today We was this. be my stated all we But they to out communications. weeks is reports that the more from these commitments if and that the today, we nothing exactly X date, are would not and labeling of encouraged they by

X within So we, else of like the for, everyone drug weeks. waiting next the approval is the hopefully,

that partner, I royalties, in they MARG to with that. the said of anticipate have ongoing Zai you would approval sometime our mean, have we next year We royalties, that getting the would -- sales be EVERSANA, obviously regard Zai with to our from partnerships, regard have expectations With for China. only royalties

So -- such and the on really in more to terms magnitude say royalties nothing the of product. of

Silvan Tuerkcan

missed a questions. might And have question, follow-up I have this in earlier I

X.X new kg. be the X that of and will it milligrams believe have was kg Will expect milligrams have and and new dosing a be X still per it I'm recently. first year, MGCXXX prostate not dosing per you data I the changed And we since in regimen the here, we'll cancer mistaken. with the I the if So around get next half, dosing question update and dose

Dr. Scott Koenig

Yes.

not during with our those therapy. that doses were analysis doses a from of as originally kg at the So those QX new these that treated started course X any we TAMARACK were have of how per start and the of altered those we start X patients mg yet dosing schedules, basis, weekly on the when patients were will on Obviously, extracted study. patients'

decide Our cohorts occur we then. forward regard with additional II the into until development plans Phase and to would we for that future when not on will program disclosure take

Jim Karrels

to the question. Operator, asked believe of address the with I asked could I questions regard if one cash first was Jessica runway, that

I not this Jessica, -- that have communication mess and we for here. apologize up

is milestones those than not our we have within for that's other reach. disclosed other think outside are eligible are that we in the line have have full about things various of portion specific potentially we and the we our we too. similar not We do adjust from partnerships. receive regards that that runway aggregate What million cash when from think we reasonably to probability example, the With amount, that a to our $XX in we with budget, prevention, do

Operator

questions. we time, have this no further At

the to back turn remarks. So for like over I'd closing company it to

Dr. Scott Koenig

the Look of technical was First at all, we speaking We at look our forward forward our to calls call. earnings progress beyond for conference future further and discussions obviously apologize on you to having snafu time. to it today, that control.

Operator

your Thank in you participation the program. for

disconnect. You may now

MacroGenics (MGNX) 3 Nov 222022 Q3 Earnings call transcript