Earnings call transcript Q4 2022

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Operator

Welcome to the ADC Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. My name is Andrew, and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions]

the to turn Relations Loshbaugh, now Manager. will call Amanda over Investor I begin. you Amanda, may

Amanda Hamilton

business operator. Releases you, announcing full results ir.adctherapeutics.com available quarter release we website ADCT our and release at and on financial the XXXX the Thank year morning, fourth This Press issued under This is section. updates. a press

highlights Jose opening Chief and financial discuss Zaki, Chief Mohamed On Ameet Chief Mallik, Officer; quarter will fourth today's our results, for Officer, Executive Officer; review Commercial Carmona, and and call, recent XXXX Financial business Officer; the Kristen Harrington-Smith, year questions. Chief Medical full call before

the I Before Harbor U.S. the Securities conference begin, of will provisions the Litigation remind made Private of XXXX. Reform would we of listeners call that within some Safe like to statements contain of this during forward-looking Act statements meaning the

to in development statements products, future and obligations. actions either launches long-term financial our clinical to with partnerships repay our strategic share with products, and our our development alone alone guidance related Examples in and debt approval either for our alone or strategic potential future FDA outstanding partners and for our partners, results future and business and partner combination for our or of programs products, regulatory ability either our and requirement or timing operating and those expenses ability foreign ongoing and our trials of products, authorities for combination efforts regulatory volume, foreign to forward-looking our our product results, growth, products operating prescription and cash achieve future XXXX, market include through and revenue revenue, reductions,

on on X-K. They on is today's risks to subject and periodic accompanying company's filings SEC differ ADCT's results and updated slide Slide in the described press Form Form in X are and presentation XX-F the and the in filings could identified in recent uncertainties statements with forward-looking are actual release, certain These materially. and

is call by any the a of undertake the required or except of or date conference this to this ADCT law statements, information, of result update conference events, as providing future forward-looking in not today's hereof, does date obligation and after circumstances as otherwise. contained information new as any call,

to substitute be cautions company limitations IFRS. on to includes considered presentation accordance with reliance addition not financial in investors non-IFRS have financial statements. for, place measures. these prepared information in undue measure The isolation also in the forward-looking These should and as and as non-IFRS measures a or not Today's

company's quarter earnings You should measures of refer the fourth measures. financial information in year release and for comparable full and to reconciliations to definitional the contained information non-IFRS the IFRS historical

pass call over It my Ameet the Mallik. is Ameet? pleasure now to to

Ameet Mallik

today. Thanks, us Amanda, all thank and you joining for

XXXX laid the optimize groundwork bolster position, our year launch elevating our of potential, was help the to ADC level. strengthen prioritize pipeline, next intention of Therapeutics, its we to which capital a all the the in a evolution leadership year for company our and team and with

unlock of tremendous company. strategic We initiatives positioned execute XXXX our are the to untapped in value the and now

PBD-based our advancing expanding through growth: pillars unfold three opportunity, We maximizing value to expect core the pipeline platform. this ADC Zynlonta our see of our and

$XX.X Beginning were the XX.X% with the sales in fourth of net million the quarter, year-over-year million Zynlonta year. the $XX.X increase highlights a full and quarter, for

approval help year-over-year, double-digit have when we and net sales take successfully, executing are percentage initiatives of momentarily. underlying you in by headwinds to will a future these focused trends gross and to drive through We to Kristen into see encouraged account, even the to a taking growth. plan Zynlonta to drive on expect bispecifics. place expected net By

year, achieve the sales development end pipeline of year. to profitability by brand commercial and not the its this them funding for to expect also We begin

believe we third the in hugely the important, only represents patient commercial this potential As a success Zynlonta. XX% while for reminder, cost segment line of around is setting

lies in combinations stage The larger earlier settings. in opportunity

and profile agent firmly single Zynlonta's manageable side strong choice. effect Here make that combination it believe we activity partner an of ideal

are LOTIS earlier of in X with therapy lines X We in studies. the LOTIS Zynlonta rituximab and combination exploring and

excited about combining with also are in we X which investigating study. LOTIS are We Zynlonta bispecifics, the

ex-U.S. we earlier $XXX expand have our in able million the annual approved billion potential opportunities $X to and If deliver for of the were U.S. we additional indication through to with combination between peak opportunity believe capture and lines, Zynlonta partnerships sales

Subsequently, to our marketing geographic DLBCL. approval to and from European pleased Sobi relapsed for receive February treatment or authorization. the UK see of we Regarding partner, Zynlonta Commission Xth, European expansion, the were in the conditional on very refractory December MHRA received

are Europe in has in Sobi this expect of that launch team good the made the and to encouraged We quarter year. second progress

but targeting As I forward the effort XX CAAG-X we an portfolio to pipeline, to rest potentially seek we further and XX across to for data. multiple our based these on driving II a turn months. to positive are of partnership pursue to AXL. preliminary value development Phase looking made to our In ADCT-XXX its in the to programs our a Cami not of own, next instead capture decision the opportunity prioritize for targeting Zynlonta, data full ADCT-XXX and clinical catalysts on Including

provide our update programs of rest detailed a the advancing strategically minutes. more and in will portfolio a are few We Mohammed

strong into and and balance on cash to financials. extend in mid-XXXX. At the $XXX expenses, anticipated cash runway the operating sheet our end, lower expect had with we million milestone with briefly a Touching we year payments

to debt of Moving our Auven in meet to its of and completed sale events Therapeutics, shareholder, disclosed as largest significant a secondary obligation. recent regulatory corporate a holdings filings, a portion

has was secondary our investors base. XX high-quality us shareholder the of in allowed to broaden shares of and million strengthen and placed The offering

was holdings process has especially the months. shown from completion locked level December after up remaining decreased for in its of shares of XX% roughly transaction, high encouraging. by And XX investors Auven's the shares offering. the the Following outstanding of approximately tier The X% to are top during interest

our strengthen with Medical the we Carmona, team Last Commercial able Officer. continue Kristen Chief least, addition but certainly thrilled to high Officer; truly our Pepe management Financial like Mohamed to Chief of would opportunity to I'm professionals. our I Officer; Zaki, Chief Harrington-Smith, that, not to and caliber our this welcome have take been

scope new in believe be expect and Zynlonta bring these company and us the three will new through profitability. we pipeline, move the grow advance the unlock advancing our to the critical the toward full capabilities phase necessary to growth. of the to next partnerships sales, five broaden leaders value years, We In to of continue next of

a like Kristen? With would to that, commercial turn call I update. over for to Kristen the

Kristen Harrington-Smith

to update is It Ameet. an share my Thanks, pleasure Zynlonta on launch.

few the trends outlining by excited accelerated have to momentum, strong quarters. in on seeing opportunities I'm initiatives how with minutes this have deliver and past demand strategy refined two our are we mentioned, spend Ameet Zynlonta’s to potential. As the we we've want and build underlying full I a to

products, various key my begins stakeholders. during My the has with few the thought learning market, focus all leaders. and understanding and been months team first listening the and I'm the It from

Following particular, things the this term Zynlonta will key delivering aspirations it's in dive, of a to really the execution doing for growth our in and be well. few quality our in that clear steep in the near

optimize Zynlonta focusing on cross-functional on thought three three, driving to And advocacy is patient We the to build continuing team key educating clear types. patient of are leaders, physicians our differentiated awareness benefit. One, with profile. Two, focusing imperatives. key

opportunity growth sprint. plus our a of the third line, both over I and these strategy, not we for believe the capture on near executing marathon will three in Through a in that third term setting longer is term, aspects the recognizing and the line this

has on line, a expanding profile, moment Starting a spend three positions plus of of to each now we become differentiated me third uniquely the standard setting. elements line product strategy. our Let awareness, of the third driving which in Zynlonta believe these care it with

profile has Syndrome agent rapid a low of a with of has with activity. with a XX It it response manageable single First, strong no just Release cytokine incidence to days. time and a neuropathy. associated median It's safety

a it XX-minute weeks. once infusion three patient schedule Lastly, a every friendly has cycle relatively administration requiring

achieve safety initiative Zynlonta, and expect profile dosing and best The to physicians how to clinical of events. to the outcome what nurses educate potential second proper on patients adverse is manageable the mitigate strategic for to and the

plus is keep the to third message. believe favorable Zynlonta's need line we and important safety profile this We in setting, reinforcing line, third

need and them for to and with we closely theirs with leaders to share experience wants our their work the community. and thought educate Lastly, in peers

landscape plus line, increasingly with availability new setting of third innovative options. is line third complex The the

get to to Now, leaders CAR-T. more than patients don't the ever, for best the community C is help and identify looking for who those postcard options to thought the

prescribed for compared XX% to As the roughly is volume patient community academic Zynlonta where large account today. as centers centers a lymphoma XX% B-cell diffuse reminder, in mainly of

a established community the Taking we in a at academic already closer versus academic setting, look strong foundation setting. the have

Zynlonta. with of around accounts Here, experienced have XX%

unfortunately utilization these be will will the XX% Since approximately focus Our on CAR-T relapse. driving post in of patients. patients

to the The earlier. greater much in experience. the community roughly by for of where the the profile discussed Based drive breadth Zynlonta, is XXXX, of potential to community tried end differentiated and start of accounts bigger we XX% At of opportunity us had that grew almost the XX% have we the I year. on

are as to are more We the proportion three who of drive specifically complexity, to progress steady reinforce tend due or to of want highly unable quarters prescribe to market our familiar community, and to making encouraged lack once as is to but growth. opportunity to believe that assets. Zynlonta large patients is that we get adoption greatest the Again, is physicians ideal continue fragmented, they setting state Zynlonta, we than toxicity, car with for the community are the it. recognize for the slower are We

three roughly We physicians. data from advantages Zynlonta, flags differentiated and have which has bring it and We of an key in treaters that other competitors of unaided to profile increase that impact can one brand awareness in market. know of opportunity to the the awareness Zynlonta's patients

unique we the We more. but efforts focusing execution, particularly have Zynlonta's consistent promotional By sharpening lot do improvement over past year, on our a profile. our clearly seen a can

of We All are our focused community initiatives Zynlonta, can is becomes levels to that awareness of healthcare critical they is with utilization, expanding order and and confident what important when systems here Zynlonta continue we that top mind adoption much higher so it. tries really to are physicians. drive

to and the To capture third the for very by line, strategy encouraged trends the XX% place line are opportunity fully utilization, this have the setting. we close, uptake fine-tuned and orders. at third repeat of important recent we Zynlonta in fact, our in medicine plus In end XXXX, we saw

to call Mohamed? the over Mohamed turn update to our on an I'll provide pipeline. Now

Mohamed Zaki

is on It update Kristen. pleasure an you, to Thank share my the pipeline.

want see for to the the a player Zynlonta. potential treatment management lifecycle in select program discuss to key I indication. be We for First,

Zynlonta what options my of therapy. Hematology emerging believe do in lines patients. remains all this here, we Oncology and see space, I spent scratched current As appreciate therapies, the you Having in career have surface. I despite can treatment need point, unmet distinct entire for at the barely And and

differentiated here earlier, Kristen however, setting, demonstrated line third the Zynlonta our lies has maximize larger to As described is patient and already utilization. profile opportunity, earlier compelling uniquely The in and in strategy a of only outside in Asian demonstrated combinations. no approved and directed DLBCL CAR-T Zynlonta studied. overlapping lines in option combinations to treatment the being and have T-XX currently known toxicities is the activity in single

potential become has a of targeted the the therapy chemo-based we setting, cell think and, therapies, second choice, DLBCL. combination DLBCL CAR-T, believe to transplant, backbone We of stem treatment and includes lines eventually about current in agent the When regimens. the line all Zynlonta

use expect CAR-Ts. see Going of increasing to we forward,

who need medical But are unmet CAR-T. access even will with there and those, not opportunity eligible be or this, or cannot for transplant still

exploring rituximab, transplant. our line in for we plus for patients ongoing LOTIS Here, second X the study, eligible not with combination are DLBCL

not notified even prior eligible they approximately This patients, to received early completed they enrollment of is combination expected produced patients for data, be The encouraging year. safety if next are or efficacy CAR-T CAR-T. the benefit could XXX run-in if and

frontline rituximab is doses the Another the need where frail there of for potential a R-CHOP. great able tolerate or in therapy, to among application combination unfit patients, full not is

and in an this to While has significant leaves XX% poor R-CHOP of deliver approximately population XX% acuity and that patients, a is unable outcome. there received about of is R-CHOP patients at

systemic this with need the is the unmet expected infusion conducting are setting. outcomes the monthly study profile patients study. on label II year. de-risk This next for this we open Phase and Based an looking failed in with LOTIS are onset results Physicians in better of and X Zynlonta,

under X. potential LOTIS the supported Zynlonta in encouraging of The a age, benefit response safety believe in and patients. We notable no showed has overall over issues from data is similar data years by the patients XX older with

the this safety and increases of likelihood the from data LOTIS addition, run-in In success. further of portion X use supports non-systemic combination of

novel combinations. exploring with we Beyond rituximab, the combination are

We profile. excited study, possibility polatuzumab. with combination as the -- LOTIS distinct particularly the toxicity we are and glofitamab are mosunetuzumab mechanism about action In of with bispecifics evaluating X their of as the combining well and

next We expect to studies these early have data year. from

with with We amount. have collaboration input a also IGM by to combine specific

intelligent Beyond different to we treatment studies, clinical combinations, different from indications. in in investigators by to our own see interest term including are explore specific and long setting substantial other in the

Investigators as of We then are closely CLL see of further lymphoma. challenging following to cell could the to understand are stronger CVA-T a those Mantle whether potential. launch lymphoma, and disease in the studies Follicular profile other amount translate into potentially biology. Such areas keen DLBCL indication in

is solid yet program, escalation The beyond and targeting starting not On to KAAGX the my robust like proceeding, tolerated ADCT-XXX first-in-class our targets tumors. the novel various final our max discuss slide, reached I X a have pipeline Phase company would is dose long, sponsor we with that dose.

to explore for and project to the different in of outcomes as to for optimize XXXX. first interactions, now preliminary schedule of prepare decided dosing data to potential half have the protocol the to part clinical expect amend aspects. regulatory We share We patients

AXL, ADCT-XXX is finalized. non-small is explore to for and solid validated with gemcitabine is expressed and lung cell cancer. including activity targeting target Now being The Phase to in and a AXL sarcoma study combination assay progressing. approach looking many over X tumors the IHC possible biomarker single optimize at

validated PBD-based over-expressed the in are half Resistant Preliminary targeting ADCT-XXX PSMA, dose majority data escalation Next-generation Cancers. Phase in and in XXXX. study from the Castration of target ADC the Metastatic first expansion is expected Prostate of X

the half of initiate the X to XXXX. expect study We Phase in first

X targeting of with for DLKX, X Phase number Anderson in lymphoblastic the neuroendocrine acute in at target from first complete signs Phase Now XXXX. patients. malignancies. expected And leukemia our CDXX of cancer some collaboration, is programs a study in in the ADCT-XXX, expansion collaboration a MD ADCT-XXX study The activity encouraging center ASH half of presented dose to small finally, NCI

We to Phase study half expect of X initiated second year. the the in be the

about reasons look excited the I one to months. forward robust over company. have I the the XX multiple of we over coming really month. This I catalysts XX on our to news next evolving am came pipeline is pipeline developed the the to flow with from the reporting

update. Pepe? to With Pepe to that, a I call the give will over turn financial

Pepe Carmona

and of Thank as of $XX balance our with a our we million reduction Zynlonta, $XXX milestone of quarter on we Sobi cash million, you, Royalty end December, quarter. expected given of HealthCare Mohamed. Europe $XX sales in receive equivalent to sheet, the from million year-end, representing Starting approval first position also commercial XXst of the Subsequent receive had cash in at the third European a $XX from million milestone a we from and the year. of to Partners second the expect

and runway into further mid-XXXX. on based our the extend I As underway, that mentioned expect we Ameet cash noted, our business productivity payment now milestone plan, initiatives

were sales net million XX.X% quarter, Zynlonta up XXXX. P&L, $XX.X fourth versus QX the to Turning in the

year full a million in than sales partial first with to $XX.X net year million sales full $XX the to compared in of doubled more XXXX. While year

reflected in License quarter, revenues fourth the amounted to the from milestone million $XX which Sobi.

revenue full $XXX partners Mitsubishi included payments the year, million For million in Tanabe. app $XX from license of our also from Sobi,

product and of fourth for quarter full $X.X in million the sales year. million Cost $X.X amounted to the

antibodies activity, commercial specifications. a this did full impairment the intermediates, meet expense In charges year of addition that reflected for products, to company's and line not

Importantly, our issues not to to commercial ability not specifications are did these expected supply and products. impact

where be r course, our of expense behind b Zynlonta line, committed pipeline heard invest early and programs. largest we're [ph], you to stage as continues promising today, and Our to

$XXX.X in fourth full fourth expenses quarter This $XX.X the to and and sales marketing the was in offset Zynlonta reflected expenses quarter year. and million quarter. professional partially for year $XX.X full fourth expenses lower line million relating million year commercial compensation the million the the R&D full was in $XX.X for share-based by the a

base in the the quarter. by in million year. and higher associated This reflected $XX.X million with quarter C-suite fourth was $XX lower the the offset and cost transition, share fees expense compensation G&A a professional fourth partially full for

Moving a bottom deleted loss for share. $X.XX the a P&L, an to of we million the per adjusted basis, the of quarter, $X.X net on reported fourth

For $X.XX million diluted our $XX.X was full loss or per the year, net share. adjusted

dynamics which XXXX. guidance. to initiatives headwinds grow turning significant growth sales with our on Kristen by Now into Based takes the we the and account expected This double-digit points gross-to-net to market percentage product net highlighted, ZYNLONTA year-over-year. compared

the point B to percentage impact negative unit implemented discarded high gross expect of impact two XXXX. the Part that together GPO points approximately a was mid-to with of at a to policy we our reflect to single-digit negative of Specifically, new regarding three net contracting, percentage wastage from Medicare beginning

operating XXXX, productivity of In terms expect all expenses, efforts as total compared and to decrease XXXX XXXX reflecting in prioritization across we and a categories. expense

upcoming the catalysts. to moving Finally,

We well XX have next months a the over number of within cash runway. different value-driving our to catalysts XX and

Starting with this ZYNLONTA year.

we addition to growth, commercial of the for so the ZYNLONTA, we achieve indications brand a costs offset by the pay related profitability, of year, to pipeline. to will all meaning than new cost and also affairs expect starts medical total that development of the end commercialization, more and In the double-digit

to of targeting DLK European second in initiate the Phase partners quarter we In expect of study this the second launch Following the year. I our year, X. Sobi, half of the approval of we ZYNLONTA, expect ADCT-XXX

the Next LOTIS-X year, the enrollment of confirmatory we study in complete our will setting. second-line

some next our results year. share LOTIS-X from preliminary studies LOTIS-X will We and also

share expect targeting the data first ADCT-XXX, CAG targeting from terms of half the pipeline, X In ABCT-XXX AXL. and we in preliminary XXXX, of to

Phase partner, CDXX. our MD for PSMA expect also dose Anderson Phase the to I for initiate ADCT-XXX, to We targeting study the complete expansion of I study targeting ADCT-XXX and

our continuing pipeline. the of milestones platform. course, company, number across and advance our to of ZYNLONTA And a we're different technology both So, with

turn that, to With I call Ameet for Ameet? closing will the remarks. back

Ameet Mallik

the Thank come. to to XXXX you, have To build clear and conclude, and to Kristen, execute ADC we Mohamed a map Pepe. in and years for road capabilities therapeutics

We of through experience. have are space discovery in growing and uniquely to specialist positioned commercialization with from decade the capabilities over a ADC

and a validated antibody an technology and next-generation with have pipeline We rich develop tumor hematological platform, assets to of programs constructs innovative novel toolbox a solid and payloads.

not place on a team highly And We strategies. we talented look have keep but ongoing in least, our to updated strengthened forward to on progress. execute and last our

questions. for available be will team the Operator? Now

Operator

is with ahead. [Operator Instructions] Jefferies Please Kelly Shi with go question. online a

Kelly Shi

Thank my taking you, question. for

regarding on the a share where The OpEx. reduction? follow-up. OpEx you XXXX? plan we more the in the And have magnitude to I cut reduction you how Can about from? details first planned should think And cost of the do is And cost

Pepe Carmona

Kelly, Hi, the for thanks question.

expect XXXX. compared we and costs reduce XXXX to both So, for to XXXX years

On a and most expect higher our the the the in we resources investment in have focusing return are pipeline. you should on that line, R&D impactful we projects because reduction

projects several know, will you attractive. have discontinued As that see could less we the

Some like of potentially them partner coming. being might end up

SG&A driving And on are the we side, productivity.

structure new We looked that company eyes. have an entire fresh at with cost team have the

significant believe to there's we year-over-year. costs So, opportunity reduce

The couldn't hear else. something on Tie second question, I you.

Kelly Shi

what we profile Yes. Thank you. to have the applied information for do other patients combo I the also rationale you have indications? cancer program And ADCT-XXX the to phase regarding custodies a question the also AXL arm at non-small escalation you. level with expression and Thank screen targeting cell a dose regarding gemcitabine is lung XXX sarcoma also, plan in AXL. the positive for what only moment? And sarcoma? with tumor Do for also,

Mohamed Zaki

order right do study for The parallel. developed us in planning and possibly enrolled for patients, protocol does the for retrospectively patients all are select to AXL is for test not question. now Thanks the assay being or And collect currently in in to current the expression. biopsies we

ready, As patients expression. able mentioned, we'll be for what to I is test

of the of is In the combination care in and standard terms gemcitabine gemcitabine of very used and active with considered one sarcoma.

add-on So, studies, isolate the care a can combination it's for to of the and future drug. as regulatory perspective see strategy able standard from that effect naturally to an be hopeful the combine improved to of we in

was what So, sorry? question, the third

Kelly Shi

of The XXX? profile safety

Mohamed Zaki

going the the currently safety phase into We profile? of escalation are The protocol.

reached not And so the far, have titrated dose. maximum we

Kelly Shi

Thank you, very much.

Operator

Gregory question Markets. Please next Our comes ahead. Capital RBC Instructions] [Operator from go with Renza

Sudan N. Loganathan

for This year quarter Congrats my is on on Gregory Sudan going ZYNLONTA great Loganathan great Thanks with the question. forward. Renza. and for taking

or for change on LOTIS-X, Specifically, therapy? you and that kind arm be the care of what tandem of as may be label change a earlier I landscape ZYNLONTA the in potentially has compare how a of point at developments go of competitive at expansion occurring LOTIS-X, wanted trials? ask to how lines comparator this Are LOTIS-X with there the forward that for arm may programs, should DLBCL standard kind looked look may

play to these in come. in are how then to five-year occur out one the And could that's frame. your the And just take time wanted year going things that developments get years on to to

Ameet Mallik

Yes.

then I think Kristen to Mohamed free it. and add start and on to feel So, can I'll

That's, quite particularly As and setting, you is transplant. some that's second say, the from dynamic, clearly, are academic third a population to going setting. there has or either in been said, CAR-Ts the I mean, moving not line DLBCL pretty of market get shrinking the CAR-T change. of would example, the a for academic a lot I to institutions

of course, much community, limited. in Now CAR-T more is the

population the there second lab sizable still so in quite population. nontransplant a And remains non-CAR-T

change. towards from study anticipate regulatory approval is obviously in which been arm, And still comparator the a feel the of mean, to terms with the we on comparator any setting. move R- design discussed right don't standpoint. second-line GemOx, label have like I the we we a In that's broader right that FDA arm,

a front-line also dynamics lot With the setting, competitive of there going on. is

cured. full R-CHOP XX% know, you R-CHOP. going dose to can tolerate patients As has of patients I And outcomes. of very good are of get mean, XX%

better who of at are lot target the to of even R-CHOP, try look or be with when can it is deliver and you to many trials, trying of to of Polivy patients augment really XX% a standard care. them bispecifics, R-CHOP. whether it And So, for outcomes the those

can't XX are years getting are full much comorbidities. are patients above are or doses pacing oftentimes for or is These and without frail mini we're the tolerate optimism R-CHOP of and now XX% who LOTIS-X where with plus rituximab playing and right and with study. chemotherapy unfit, This our regimens, ZYNLONTA R-CHOP with other these of their patients But more.

study. a population, And it's this in single-arm

So, is R-CHOP, comparator point. for If comparator it's and mini this hasn't move a really really not that changed. we the were this at obviously, to forward,

So, we don't think going current alter competitive the to is are. plans landscape development our what

the think be landscape introduction across thing I big they change over could where treatment the start chance the bispecifics the to, potentially of time, to have all lines of therapy.

think partner we're positioned actually we And well to with bispecifics.

the CDXX to efficacy be and with even manageable single-agent As believe we overlapping, has side potential has of and tested. not effect targeted therapy only the profile, course, be to

doing to We we're are partnership uniquely LOTIS-X with that our and different study imbodimab our as as compound. combine in across with in well IGM positioned bispecifics,

actually we chance of a we the think biggest So, coming changes combine ride with years. competitive the affect have DLBCL and I actually to over think one that will

Operator

Harrison comes with Stanley. [Operator Please Instructions] go ahead. question Matthew from Morgan next Our

Securities. Our comes Please One Instructions] question ahead. from go [Operator next with Quibria Naureen Capital

Naureen Quibria

the progress. for Thanks on Congrats question. taking my

So how respect front it's do line? share with first Polivy to, Are guess to that have the I And date? basic. you third in line fraction penetration line, And plus you to to on comment the see very you market penetrated now ZYNLONTA's what able one, DLBCL? moving obviously, third

Ameet Mallik

there's but that let believe comment still we the say just details. further can I'm to Kristen lot of going potential, some on I a of Yes.

Kristen Harrington-Smith

Sure.

and later space. a especially market now, just no the data years good for source really space It's lines. is dynamic in DLBCL share, the very in and there worked of fragmented I've for So,

in when continue to is by research to and However, space the at we use in line that a the standard third-line here. we're data. confident brand really look setting, our and this we What and new penetrate further we're care third are we seeing potential impact encouraged patient leading of and the our share become

Manta. orders. you is the shared tried community have sites look where try it, opportunity is community greatest news also upfront, of where of only good that the in in we they we market that to they know at things continue setting, that was see our penetration, repeat one XX% The When when I

to So that setting. that is continue opportunity our grow in third-line greatest the share to

Naureen Quibria

Okay. Great. That's helpful.

is first? guess to if might I give any be that more you Sobi launch, guidance the next be you a probably X And Are provide the more. countries like bit might Pepe. for two able So, color targeted for able trajectory? which to on

Pepe Carmona

is and the for that net a agent to guidance because with single it's approvals provided what arm, we you market a haven't -- throughout is Europe. to single process have but with there, take access tell it's We longer can going

So, gradual it's going to growth. be a

see I'm if to add want something. going to Ameet

Ameet Mallik

other as very you take it study, in country with Pepe market some I said, by going in is in countries. access mean, country know, to that No, and it's to Yes. Naureen, could result single-arm Europe, approved reimbursement months. favorable and up reimbursement given XX it's And as in a countries more challenging

greater is CAR-T Europe in potential you than because term I the the current will open in we think in with study. think European longer comparative when about less. the if I So, But launch U.S. much as Europe may full opportunity volume the even in more Phase opportunity, LOTIS-X, the penetration it up of be this have kind is I a study see Europe.

Naureen Quibria

in the And the in helpful. behind more update will schedules? that With up? more the to different patients What's sort That's how that with CAG-X -- -- should bit we protocol just levels. decision? upcoming the And Okay. very come and to for the about dose of expect squeeze With many given could Mohamed. you dosing if rationale the shift, one XXX, the amendment talk I the respect can a

Mohamed Zaki

novel ago was a to you Thank looking for a it know, weeks Yes. came at the the CAG-X with the fresh question. Actually, as perspective. company, actually. you I And agent,

agency quite Project So, an which we asking experience technically Optimus, doses agencies also exploring with multiple about with schedules. and the have discussion

explore redosing prepare study. prepare a dose for experience the to took installations the decision convenient for most regulators utilization to the schedule we the ready post protocol amend So, future also to with patient the for with to maximize patients the pivotal and to possible and for meeting

got protocol accommodate regulators just I -- and in in come many the each a guide companies as requirements Project of them new now January indication. adjusting preparing for number with are dose in So, right with Optimus say, each the to you published to multiple the for around world requirements, as to patients know XXXX, so also, the doses

I question. So, your that hope explains

Naureen Quibria

does. it Yes,

Ameet Mallik

we that process in to you're be Yes, dose-escalation Naureen, I escalation to probably I that doses. is to general, to multiple you're expansion, expect going their dose going at have going have to expand like think because

Operator

from comes [Operator Instructions] next Matthew Please go question with Our Harrison Morgan ahead. Stanley.

Unidentified Analyst

you specifically earlier Matthew. taking entering for treatment impact market help market? kind paradigms question. new asked us as of about Can the for Thank bispecifics. the on the potential the know I entering they that about XL of penetrate Thank plus DLBCL my near-term impact you the you. of for think of market, Chris is This kind someone

Kristen Harrington-Smith

Sure.

play with do the icam We and the general, we to to to CRS a in uptake in third-line In limited risk bispecifics, role new given of think academic will So, approval. centers. expect [ph] we bispecifics upon initial be community take longer. the that think slower And therapies. community the will setting adopt uptake is the

trials. the now centers, bispecifics to space studied in been we've comes in being bispecifics that with competing given competing clinical multiple for that it academic the are in setting, When years in that

Unidentified Analyst

Okay. Thank you.

Ameet Mallik

the I relatively low. would in penetration still just that the add agent any is of setting third-line

the magnetic the community grow in for, there's setting. room and to and bispecifics sensing, academic penetrate, to for continues So, particularly both clearly

Unidentified Analyst

Thanks. Great.

Operator

[Operator Instructions] with Boris ahead. Please question next go from Our Peaker Cowen. comes

Unidentified Analyst

couple for Great. my for for ZYNLONTA on trials. just I a taking question. Thanks Nick Boris. LOTIS and the is This have

in for from can trial, the or regulatory For both but know I used U.S. the DLBCL this an be submission EU? the and SNDA is a this trial for LOTIS-X confirmatory arm, single

you also that is And approaches then for of are looking based second, lines which or at? LOTIS-X, And combination therapy Thank guys which whatnot? different on you.

Mohamed Zaki

plan So, confirmatory ZYNLONTA regarding second X is correct. setting, to patients the next also potential SNDA that into third single LOTIS to second regulatory getting worldwide is and we Remember, and study It - U.S. in is number It the are line-plus for approval. U.S. at study in absolutely that and a get is agent line-plus agent. the both with for line-plus you're a go that with a setting. substantial with a maximizing the of a setting and

Both what want… sorry, I'm you --

Unidentified Analyst

Yes.

For LOTIS-X.

Mohamed Zaki

multiple glut and including polatuzumab, have agents actually mocituzumab. We're in combination,

with trying choice that have to a drug to with the also IGM of bispecific, are with combination bispecific. collaboration or their We we in mention be not

of So combine with approved bispecifics be combining pretty with. any able become whoever much be all backbone, to and a to we're in the we'd them landscape, gets

that's answered hope I question. your

Ameet Mallik

change the Yes. change amount be And mean, an if combination of think will works in I therapy. it effect the particularly therapy, opportunity a Particularly to I to of expand to earlier profile in has responses, and starting in lead I durable imagine can setting. a line, landscape. the And you outcomes, second second-line way that an for that there's lines side really combinations therapy responses and manageable even is deeper of more think terms and targeted better opportunity

Unidentified Analyst

Great. very much. Thank you,

Operator

[Operator comes next Cheng from question go ahead. Instructions] Our Please Brian JPMorgan. with

Brian Cheng

used a the was how question for ZYNLONTA. do first the of see think you split lot community Kristen. is term, And how bispecific taking you to market's more you follow-up. about a you I that in? you coming as for long traction with What community you. changes you in think question. that growth, just last Thank it have my near do take Thank the quarter And there? get And for emphasize will academic where of versus My

Kristen Harrington-Smith

Okay.

the consistently academic And of in started volume. community from terms see the is the started as we it's academic of roughly to in growing. versus an terms community to XX-XX. We perspective we've use So, penetration of in said, match youth, just just -- split the

was for is treaters five generally to see adopt start is to see -- four slower could slower long most new that new peak hit to launches, to probably years treaters community communities because to longer we do is that the market what it But they're really adopt community share. They take what second it penetrate in Your setting. for are we takes therapies are oncology to how community. -- question about a

But continue we're since about we will XX%. chip to at away

academic Our setting. we're in goal seeing match is really to the what

Ameet Mallik

And there's tail. that I'd long a also Brian, add,

lot lot stickier. be a in doctors months. few every also they a to the centers. community a of there's seeing fragmentation lot So, community tend But of patient are A

adopting takes to with are both sticking changes behavior is the are repeating works It's that longer accounts So we adopt, but product. and ways. see the

keep growing And month-over-month. penetration and so -- we

we a that further. this about is challenging of think, for you are safety academic bispecifics, the Kristen time, as In we the a even believe, happens, asked comment and with that's spending, in accounts where where I place Bispecifics bispecifics. So, still great room much and opportunity, we've let a there's just XX% had have death, the I'll think about to given initially community going more penetrated profile.

the Kristen let point. comment on I'll bispecific But

Kristen Harrington-Smith

add the academic bispecifics those uptake have ICANS events accustomed right generally profile will reserved but don't else we for CAR the adverse see why we I treating setting. community the not to are -- setting. in Sure. That's that be being the just Ts one that, initial academic are where CRS, much to to safety the of now.

opportunity have ZYNLONTA. it feel And again, our that will now we take time. right is grow So, greatest we where to

Unidentified Analyst

LOTIS looking Great. data rituxan, a your combo remind analysis built line do that interim And there the in you you see wit And study? this second an trial? we when us into of is whether from in then can could at sense X have

Mohamed Zaki

question. for Thanks the

completed be XXX next to study, We when study. in analysis the not year. not to interim There the of of it's expect an we'll patients the end And the be enrollment closer get protocol. for update we built will

Ameet Mallik

-- enrollment the Yes. post it's lines event-driven And any depends time an obviously, study.

some complete it close in and to we enrollment share on ways, but information. out, Once peers, also we'll the depends starts the study longer So, reading events.

Operator

you. Thank

back I'd for further Ameet like now at remarks. no it closing to We this to questions turn time. have

Ameet Mallik

thoughtful ability ZYNLONTA, Well, ADC unlock questions. platform. the of by thank and the maximizing much joining for to our this by excited you we're our the and expanding for our all by really all webcast, company pipeline thanks about value PBD-based so advancing

forward catalysts next progress. XX months, have to we value-driving our and to XX on We over to continuing the update you look multiple

Thank joining. for you so much

Operator

This today's participation the your in concludes for conference. program. you Thank

disconnect. now may You

ADC Therapeutics (ADCT) 28 Feb 232022 Q4 Earnings call transcript