ADC Therapeutics (ADCT) 7 Nov 242024 Q3 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Third Quarter 2024 Earnings Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 7, 2024. I will now turn the call over to Marcy Graham, Investor Relations Officer for ADCT. Marcy, please go ahead.

Thank you, operator. a and announcing business issued XXXX third we results financial update. morning, press our release quarter This This release of and today's website. presentation the slides we available the will on Investors section the Therapeutics are ADC use in

quarter joined Pepe Mallik, will business Carmona, review Ameet highlights; who I'm Executive by our and third operational who today's will our discuss call Chief XXXX on Chief Officer, performance followed our financial recent results. by Financial our Officer,

the We to call will open then questions.

The presentation X-K. like SEC, would and to of and statements U.S. and circumstances, I in safe the Before remind conference listeners will any materially. the forward-looking XX-K, does information begin, we accompanying as of any statements slide Litigation statements Private and not These to the statements of Therapeutics some obligation to today's meaning providing in ADC Reform XX-Q as made date the known call future the forward-looking that harbor subject They cautions or undertake contained the provisions of described by except this Form of this company including update statements. of place during not law. new as Securities and in within are call contain forward-looking XXXX. forward-looking result investors the achievements could results, are actual performance undue and identified events reliance differ required and these is information, to Act uncertainties, company's certain this filings a with and conference unknown on risks

or be prepared not considered financial for reporting. non-GAAP and non-GAAP with as in isolation in GAAP. accordance a to addition information substitute also should measures the in presentation includes Today's These

quarter should comparable to You of to non-GAAP measures. historical the and measures reconciliation GAAP the third earnings release information company's for refer

turn call to Ameet? I our CEO, Mallik. will now over Ameet the

everyone. morning, for good joining Thank on today's and call. you Marcy, Thanks, us

company. Even a our able our solid we for DLBCL. to period patients Throughout we delivering strategy. been represented market, focus place continue for competitive of and third on continued a in performance of a highly XXXX with plus secure as third-line commercial execution option treatment the quarter to The have quarter, our on

to quarter, ZYNLONTA net $XX.X during quarter product bringing million $XX year-to-date the million. revenues revenues third increased to Our

are profile rapid, and ZYNLONTA's in We confident deep administration. efficacy, profile durable manageable ease with a of and safety

and believe our in expand the the significantly to lines use current through growing combinations, earlier the opportunity. into we commercial DLBCL indication, of indolent potential Beyond of therapy ZYNLONTA lymphomas in

in with Enrollment prespecified by LOTIS-X of with half expected in patients plus DLBCL expected our number of expected events anticipated LOTIS-X, ZYNLONTA combination our is this data reached. including Interim year. Part patients first with efficacy subset nearing with of the of once XXXX additional rituximab safety in a glofitamab end the completion and second-line are plus end arm of in XXXX. plus in DLBCL, by in X combination Phase from dose ZYNLONTA expansion the of data, in second-line are study is Data enrollment III confirmatory the of the full December

data We IIT an II we Society these from ZYNLONTA of updates look the in in potential the well Center lymphomas indolent that ZYNLONTA follicular II evaluating are Comprehensive be with excited Phase relapsed with University ZYNLONTA in to with patients zone with IIT updated data a for forward Sylvester studies as includes key or the at as lymphomas. refractory at rituximab will these the the at presentation investigator-initiated treatment Cancer presented in marginal addition, oral studying evaluating Hematology ZYNLONTA relapsed from in from Miller In evaluating Miami poster X the conducted Medicine, combination Phase of of This X presentation of refractory December. Meeting or high-risk lymphoma American lymphoma. the School the updated trials of

I/II Phase Texas, dose. in and patients evaluating Cancer MD B-cell dose Anderson XX with per of at ADCT-XXX University relapsed to leukemia the microgram escalation Center, by sponsored acute continues trial kilogram The progress lymphoblastic the continues clinical or refractory

Within our the AXL Ib programs, discontinue solid lung non-small made patients a targeting tumor agent decision we in as to pancreatic cancer program combination and with ADCT-XXX cell have Phase the single sarcoma, and/or cancer. with

the unable of observed phase. and expansion signs were phase, demonstrate were risk antitumor escalation profile activity we favorable to early during during dose the dose benefit a Although optimization

Moving prioritize where Claudin ASCTX exatecan-based solid NaPiXb for progress targeting our company's studies drug X, our continues the the move the ADCs PSMA in At and ADC will expected stage. XXXX. partnership forward, to company is tumors be toward candidate IND, exatecan-based programs one in while the has for we in platform IND-enabling continue explore to in which time, The same selected we opportunities. to selection targeting disclosed is potential target

Looking move specifically DLBCL. the at When frontline, are beyond low. rates cure extremely you

efficacy, safety second-line DLBCL. considerations. in accessibility the X, patient in well on context delivers plus all based individual of decisions positions on we which believe use ZYNLONTA treatment make combination in and physicians it Here, for

X administered The as and towards combinations moving chemotherapy ADCs deep, setting. cellular market manageable responses is with offer durable that essentially bispecifics, which can in as to modalities: therapies, well has evolved the toxicities, rapid, be antibodies and outpatient monoclonal

cell to clinical we the expense potential profile in believe grow Given the chemotherapy the and and with combinations, the these ADC-based regimens use. bispecifics therapy of at have improvement expected

combination are efficacy our we therapy promise convenient ZYNLONTA a safety Here, second-line and suited well we LOTIS-X, see therapy. LOTIS-X is use are DLBCL the favorable LOTIS-X with care physicians competitive settings. With a community schedule, backbone feel studies. dosing a for rituximab, of using with and across and combining that plus combination comfortable of this offers We

avoids irreversible plus still In a nonsystemic is DLBCL. associated a with second-line class chemo that regimen chemotherapy, the this widely addition, toxicities is used in that

and no With signs LOTIS-X, ADC, CDX antibody combination an early toxicities dose combining are antitumor the anti-CDXX engaging an dose-limiting bispecific activity. completed we and glofitamab, where anti-CDXX, T-cell and ZYNLONTA, of have escalation demonstrated

single-agent is additive have expected to powerful efficacy study non-hematologic or these this is along overlapping drugs with profile given synergistic safety a hypothesis manageable Our toxicities. that with approved X combining no

the may and This across B CRS in open this used debulk settings. care of In combination therapy leading to earlier addition, would severity. peripheral we use lower tumors believe and of lines up to rates the ZYNLONTA glofitamab reduce prior cells,

on in at saw Ib We patients data available. scans enrolling glofitamab the This where second DLBCL. are and plus levels with the and from and data XX to ZYNLONTA XXX dose all sharing plus DLBCL ZYNLONTA with doses kilogram dose anticipate efficacy X in X in includes glofitamab and line escalation X X encouraging safety expansion per We XXX Phase dosed Part Part in December. dose are patients in combination with XX currently at patients Part microgram

the We patients first of expect to longer follow-up half with additional share in XXXX. data on

lymphoma and and ZYNLONTA lymphoma. fixed ZYNLONTA Beyond deep University profile. trials these refractory potential for relapsed to and from effect exploring the DLBCL, of monotherapy into Miami the at plus manageable second-line zone of or duration data rituximab durable follicular demonstrate in or the rapid, lymphomas potential in also see therapy marginal investigator-initiated Early side expand studies efficacy settings high-risk the of refractory a relapsed we on from with a data based plus indolent

remission. metabolic studies, the there complete zone lymphoma response we Based follicular provide marginal is to on years potential high believe rates patients and thus in the of far seen these with

studies the at looking more on ASH the sharing December. these lead We forward to in are meeting investigators

with seek these need plan forward we unmet authorities path as as significant remains discuss across with there data, in compendia. the As lymphomas sufficient regulatory to well inclusion

With to would over to Pepe. like that, I turn call the

to third ending front, the In plans. remain financial Ameet. cash the operations fund based and cash in capitalized, is mid-XXXX we you, expected on quarter which well into $XXX.X million Thank with current equivalents,

net compared first to million months were and $XX.X for $XX.X quarter XXXX same in as $XX.X ZYNLONTA third product the million million and revenues for of the periods million the XXXX. X for $XX.X

a driven by third The non-GAAP prior maintained of strategy year, is net X have primarily year year-over-year increase growth volume XXXX for price disciplined Throughout excludes XX% we compensation. expenses versus on our allocation which by the stock-based months and decreased basis, the first with increase. quarter operating capital a together

I non-GAAP our due prior increased efficiencies expenses by in trial in X% operating by other Phase versus investment expenses. program, offset ZYNLONTA In third as year clinical operating the LOTIS-X and acts quarter, to partially

We year. will our XXXX capital to and disciplined coming a take remainder allocation of into the the approach through very continue to

You the press of of financial a GAAP issued release reconciliation in the find measures tables in today can accompanying to the and non-GAAP this earlier measures presentation. of appendix

the as compared period $X.XX basis, GAAP or a loss per we per the of net and net or million for share $XX.X to On basic of a a share reported in million and $X.XX diluted loss diluted same of $XX.X XXXX. loss basic net for quarter

as ended $X.XX an compared share adjusted XXXX, XX, in related primarily net and On decrease loss or the basic decrease XXXX. a $XX.X September was per $X.XX net is adjusted of share adjusted operating or period basic the loss loss is million net months The lower and non-GAAP million expense. revenues, primarily diluted due for year-to-date basis, $XX.X to to while diluted same to per higher of the for X

believe strong to corporate financed pursue well our With we balance we're to our strategy. sheet, continue

within As a key to reminder, hematology beyond use current of objective focus this, of create indication. by a is capital allocation. value ZYNLONTA our our the primary our expanding continues And to be

DLBCL behind partnership to by potential commercialization through ex into by directly efforts our lines achieve our of expect this the and indolent and lymphomas. U.S. supporting in fully We and earlier expansion investing U.S.

solid exatecan-based multiple In our research tumors, through aim on to our pursue increase shots goal ADC candidates novel and parallel is our in platform.

progress internally a partner financial or candidate to the to share case-by-case on forward order will to determine seek taking are addition to and candidates development we the IND, additional we to basis risk. whether In in wish we

back I will turn call With the Ameet. to that,

Thanks, Pepe.

maintained for progress excited to illustrated is about remainder approach third what and in the are made our the we we've today, ahead quarter, As disciplined capital of allocation, significant XXXX.

the year. catalysts indolent LOTIS-X, potential of LOTIS-X this at in Part and from key and efficacy X as completion before data well updated data the enrollment safety end we milestones, expect Phase have lymphoma expected of presentation December initial of include expansion in value-driving II We ASH. dose as which These IIT

balance ADC our with is Therapeutics confident all well value for to execute that sheet creation ahead Looking strategy, am our positioned I drive a to strong stakeholders.

open can the for questions. We now line Operator?

Michael Your Schmidt of [Operator comes question first from Guggenheim. Instructions]

when it's little the look be its category. some to comment a grow dramatically, ZYNLONTA they the seem about recent I launches, approved Could at bit but of more meaningful you antibody some of CDXX commercialization know experiencing we in expected a uptake indication? mean, I not similar bispecific to in

I'm a I from follow-up. so current right growth terms incremental in approved curious, the in opportunities are you indication? potential And then And run just now had the and seeing what of again, rate, utilization

Thanks, Sure. Okay. Michael. the Appreciate question.

in the a from has competition Since the had the launched there they some community. obviously setting increased in bispecifics. setting well third-line been penetrated they said, you significantly into As ago, over inroads as academic pretty made as year

One academic thing is going to see referrals bispecifics. and we access for patients more get community between the on to

So plus close they've X/X certainly to probably share. over market the overall about third-line of taken

think competition. excited at look pretty I with what team all much I'm despite in that the is overall line it's volume, if about you our

to stable continue maintain the demand and community we relatively So a setting. academic of mix between

still there about last can it's variability. relatively use order-to-order be like normal for Obviously, advocacy But quarter, said XX-XX. community. So and there's the use by ordering academic strong -- of we ZYNLONTA physicians we quarter-to-quarter the see in --

And sales we've million been possibility seeing, the the indication. continue to continue peak the we to think to I potential current $XX-plus see see. in trend an that anticipate for So we

I LOTIS-X know expect patients the about on said to XX later XX data And with present year, on to this Great. you data glofitamab. Okay. you

is initial What you LOTIS-X? are what data for looking this in positive here? So result a for

great it's Yes, a question. I think

there's overall be mean, enough look combinations of bispecific rates. been look if at data. CR or out and response I survival. rates and overall combinations, obviously, have come we'll mature a you with to that other data and won't And is at What So bispecific PFS PR our have number

second-line to bispecific the you they're If when the mean, combinations, the you at setting. kind that, of tend majority look at range you the to at that look XX% in in if plus be look they of I XX% range.

want hopefully to what and continue be which escalation, but an is So saw overall to CRS. improvement we rates to profile, dose of continued also severity of competitive in course, we efficacy from in show the the

things data the so the December, it goal that's be to we'll are the have those share. Obviously, show X and And the in able let to for we to hope but mature we profile.

terms best in time. competitors when of I One matures thing or by also would note other over that just data reported and is overall it's rate best in trials, always efficacy response That CR. is about

but scans, as year we'll to data on next expect share be over to we able but share so not preliminary and this as I year, updates think go we also, well. time, just the matures And into to data continue

next Schmidt Eric Your question of from comes Cantor.

and Is that Maybe the or from was I Ameet target you of decision coming this the payload Pepe. sort Appreciate maybe quick there safety solid the was and PDV update, go AXLXXX learned regard anything to, to the don't with to just in just here? a or back your or linker give tumor it opportunity. hook know,

dose led mean, think I I interesting optimization. you're clinical see in we more basically as sarcoma, doing to the we which initial did the investment dose Yes. expansion say, did monotherapy when activity, what's and limited we let's shared both when to the dose giving some is escalation, And obviously dose do duration. That the escalation, you're combination. had

was a therapeutic index. the with there limited payload knew combination, and target We

wanted things weeks. we've dose versus Or at programs was to And so a of other schedules, example, one X done look dose. down what start higher different and the dosing then X we with in for

so that And with to a optimization played profile. see tolerability during expansion the we we weren't phase. able sustain efficacy unfortunately, with to But of want and level we dose favorable the

risk optimization dose saw benefit phase just expansion that that during the wasn't there. so And we

target that we saw more dose -- side the levels versus would get say It's that as of to to efficacy at high to were to the hard effects to continuing is we speculate want how But we limiting much payload. and I some were see. just

endpoint. to we reason made have specific So call we a is wanted the the

we're said going stop to see we're to or and go up think program. signal we out a do either strong the strong a we patients, dose going profile we XX efficacy to going remember, we're that to BD and You deal a can

it with, so decision And further. made very that we pursuing any we wasn't just disciplined we go had worth go/no that and criteria stuck a

lines little more on conclusion a the and/or specific be Appreciate discipline. a filing Can partnership bit solid discussion? IND you next time for tumor

Yes.

shifted really solid tumor we've towards strategy know, you newer as So payloads. the whole

that. So exatecan we have know, most X and as in you programs advanced, is the different

the towards know, on already give that we're We picked our an you will future. IND. update in one progressing mean, I program we've as own

that. We expectation haven't timing the on given

going in a update. just discussions around happen to future we other set partners for this We collaboration in I will that's give of that with anticipate be some year, expectations. potentially to And the continue to programs. research don't

event. I think it's more of a XXXX

you about we the And time XX an get [indiscernible]. between so to Eric, we obviously, can fluctuate, to IND, It selected drug going in candidate but takes said, Ameet average, selection roughly it months. until the drug to that's the that's already that. line as move on

Okay. Pepe, on you, And sales. for ZYNLONTA one quick a

or I net think increase quantify the in percent Could mentioned gains. magnitude you net pricing? pricing you

a price twice digit. year take increases We low in Yes. single

roughly. So compounded annually, is digit mid-single

comes of question Jefferies. Kelly next Your from Shi

are on what ongoing trial, expect for there curious, And you LOTIS-X this durability combo, of any for this centers So trial? just involved also are kind synergy particularly from community front?

Yes.

either ZYNLONTA we're testing, of that's cell Obviously, synergy. see is, is because CDX efficacy mechanisms. right, CDXX, to and a additive CDXX are what obviously, is synergistic glofitamab ADC T these hope bispecific. complementary we or So course, to see

or So we efficacy. synergistic additive hope to see

we're of of a because And rates debulk way we're hoping by that, CRS. before dosing the that tumor, week giving the severity to reduces also the and the ZYNLONTA

of So the both dimensions prove profile to really bispecific is the monotherapy. on

large in in don't community that centers the trial, centers well CAR-T. CAR-T as as centers we centers. of are academic and terms in In We're give

to it's in of the whole really representative think we're patient plus really So because sample. second-line across sure that sample make testing we're to trying patients this test important we a

bispecific patient combination other a that's trials. with large-scale You very expect should sample consistent

comes from Gregory Capital Markets. last of RBC Your Renza question

chemo? I I look value potential bispecific here Greg. what of curious, meaningful as to as I'm follow-up. or LOTIS-X, bispecific be proposition On to effect mean, the plus the a update perhaps reduce key is one for in would data the that This is from to profile [indiscernible] a such then side on CRS. like initial improvement considered just have And need

Yes.

obviously, dose its escalation low most is on in the saw own thing, XX%. we in meaningful Glofitamab think what the the roughly I was XX%.

important, is Tylenol CRS, but more at CRS obviously important it of X look as I sometimes think treated as rates ], X, Grade Grade when because could you [ are hospitalized. you're severity be So simply even

between difference And the these high-grade significant. to very option and to grades Grade hospitalization, even requirement is for the I important remove of think So thing X. is especially rid or CRS, so the Grade get X

high-grade escalation like dose CRS. no would saw what we to So see was the we hope in

the I want important that's think too. efficacy that again, we most to part standpoint. strong, from that's see But also

versus we're bispecific think on to I So the hopefully improve dimensions both monotherapy. looking

of a as can I And the you like we follow-up, listing? sizes could help -- needed us the to indolent should line, for help help to remind for that what compendia do pursue set route? -- also ASH? data just refine are it. at be that sufficient can And this expect that will the set what And us, when maybe I'm data the mean, you update have expectations Got curious, be you lymphoma if time you

sure. Yes,

saw as on from we that just So study Tuesday, and as relapsed/refractory data a were press both relapsed/refractory abstracts you the summarizing MZL FL released the the abstract high-risk study. probably the well had release

as in an So oral is with presentations, a you things. the It's poster see would presentation. is what MZL updated presentation, I FL most expect data just

course, and presentation. when that the provide update So in summer, more duration have detail and further will with in investigators patients data the they, the to of more submit

ASH. what So expect at you that's should

only gotten the in needed, a terms most XX, kind was you I even there that been so when that it's And more sample it's patients. at of patients. as have when to guidelines, inclusion. where then about of XX And precedent, there's little for around XX MZL, approvals, -- would in been look been The say, of patients of has the are sizes number as patient

would So range, of say. the that's kind I

doing XX-patient a We're study.

in regulatory abstract I patients. be was submit presentation to level to that And -- You I durability more patients we'll potentially be say, there'll would that's -- into can a more that into expect to when to that because to get enrolled. you probably get -- have data has discussions the that also been of or be few data in the would XX with to of see to to to be able with have some guidelines authorities. get range, was the presented -- have get see sort to able

bit follicular, is number of there's With high-risk a patient there's studies. gone these have on, The III a precedent little patient a though head-to-head patients it's a only that Many less are population studying we're PODXX. of population. studies because about unique the thing Phase of

So unmet the population this course, is higher. need, significantly in of

And a on a doing discussions have and high-risk we're Remember, more we study, population. is which patient large this may pretty so There's this possibility patient study be the submit there with in a XXX-patient path to accelerated able be would more narrow population. that possibility. in a FDA

And data? of in you have when to time enough do line, terms the expect

I is on will mean, more at what see you'll now. you'll say I would the guess, next was where I update real what Yes. abstract. That a in details data the versus ASH further the see be update

these timing, because any of haven't investigator-initiated trials. obviously, terms are In both we updates given

enrollment the our not is in So control.

the we need enroll. to earlier in continues be see high prior gave both interest these unmet updates these versus I the year, and you'll of that settings. year There think this continue that given just to

our I and Thank CEO, session. Ameet ladies gentlemen. Mallik. you, call to over now back turn the Ameet? question-and-answer That will concludes

our joining for look end and please call. on keeping We today progress. Operator, you to our for forward continued call updated support. your you Thank the

attending. for you Thank

You today's may concludes disconnect This your conference. now lines.