ADCT - Earnings call transcript Q1 2021

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Operator

Good morning, and welcome to the ADC Therapeutics First Quarter Results 2021 Financial Call. My name is Cheryl, and I will be your operator for today's call. [Operator Instructions]. I will now turn the call over to Amanda Hamilton, you may begin.

Amanda Hamilton

Thank you, operator. a and announcing business issued XXXX first we results financial update. morning, press our release quarter This This release is ir.adctherapeutics.com under available on the Press section. ADCT Releases the website at our Chief On financial Chris Jenn results quarter call highlights Creel, will the Chief Executive and Chief Officer, and Commercial for Financial before recent Officer; Medical today's opening Officer; Officer; Martin, questions. XXXX Jennifer discuss call, Chief review Feingold, Jay first Herron, business our

statements Such subject call may contain and As to a reminder, uncertainties. statements. risks this conference forward-looking are

additional concerning the our cause Statement Cautionary in to materially on report Securities expressed For information factors you of U.S. forward-looking that as filed Exchange Commission of and titled implied actual from Such Regarding Form statements X-K could earlier Forward-Looking or these and refer section today. differ the statements, Statements we results date in statements only with to the XX.X those speak conference to substitute call, we this in the to, Today's any forward-looking as addition measures. applicable disclaim includes to so presentation in should expressly required not or These these information also isolation law. with have and considered IFRS. non-IFRS unless be by update of financial limitations a measures and do in financial or accordance undertaking and non-IFRS prepared as obligation measures statements Exhibit for,

Chris? to historical now the measures CEO, company's earnings is Martin. release quarter to non-IFRS pass in comparable for measures. first refer and to should call the You information reconciliations the our pleasure information of contained to IFRS Chris my definitional over It the financial

Christopher Martin

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

been first months have transformational exciting. and this The few of year

a being B-cell high-grade Zynlonta the April than studied label transition in lymphoma a were an pleased We PDUFA high and with we priority X Zynlonta differentiation. accelerated includes to weeks lymphoma since the to accelerated lymphoma, the know, FDA lymphoma. follicular and launched DLBCL arising Zynlonta need on large FDA patients fully DLBCL a the remains important the supports Continuing XX, not highlights as NOS receiving approval added DLBCL organization. lymphoma, were FDA approval, patient population guidelines on for B-cell before with less reflective receive The II from in immediately our the Phase of low-grade seamless treatment trial, profile not low-grade latter population. such XA patient of commercial include guidelines research Based date. marginal otherwise in As programs to approval This the NCCN arising lymphoma clinical indication a from also yesterday, after high-grade for diffuse We was with the the broad learn to also extremely Friday, integrated advance a rapid recommendation. and differentiated addition the broad month zone B-cell unmet that medical and are this NCCN specified, you Level to point treatment making company. the to but only pleased approval,

earlier lines as Cami, and therapy follicular Officer, more the clinical well few the indication to advancing We're over our detail we of lymphoma. tumors like first, on our combinations highlights first lymphoma call solid provide Hodgkin also will pipeline. the earlier-stage Jennifer, of Jennifer? launch. Zynlonta are Jay discuss second as in to to would the days first in pipeline exploring DLBCL the Commercial turn shortly. Beyond I in our Zynlonta, some But Chief program, and different for for and studies

Jennifer Herron

ground of and a the with Zynlonta medical ready running. were the Thank update launch PDUFA hit commercial FDA you, early everyone. the and Chris, an coming before Even and very the approval I'm for on the excited date, hello, teams to month provide launch. have days already

with we On the underscores treatment refractory received critical for approval, the for lymphoma. need also patients large same first new and received inquiry options product customer day This availability. relapsed our we diffuse about B-cell

the our care website brand medical patient our platform, as website, includes approval, well as health Over launched site, our we which professional website. our weekend digital our assistance information following

We co-pay one-on-one also outlets first XX, FDA leveraged all was that On direct media with are guidance, provides center, customers support e-mail to approval, social coverage live day reimbursement ensure which Zynlonta. trained great nursing call nurses Monday, aware news support, after patient assistance April of of and the financial our and and the specialists. our about and business

the HTSes our were HTSes and very We also same field in sales training customers. payer day hematology the for following was specialists available our Tuesday, business dossier promoting for the AMCP therapeutic day. or second our completed our the approval, Zynlonta

MSL has been ensure our addressing Importantly, of customer the safe to efficient administration Zynlonta. and team requests

the In of so. talent benefit our are and of truly members had Zynlonta days weekend. the the we news to differentiated market Finally, reporting and commercial patients access with are teams approval, start, first Zynlonta that customers In we the institutions Driving express and positive recent Zynlonta, major is reception customer-facing opportunity of approval. the was The can a guidelines, product excited first from was interest are approval genuinely which addition refractory to DLBCL. the running with medical of within commercially bring order has marketing, of medical, exceptional to a hope NCCN launch to with position industry to very the team from days every sales. seasoned team patient encouraging a a initiatives to that available, across the world-class relapsed and sales Zynlonta in and summary, shipped access of sure our is days hematology/oncology professionals our these their over do in make off is have treatment teams very to the very a to hearing in of team FDA FDA ordering of top early since Zynlonta the and launch. And accelerate

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

Jay Feingold

high-grade the Jennifer. keep least Zynlonta going. our a lymphoma I trial, review LOTIS-X total share enrolled to that was our approval and Phase with patients heavily The respond a did to pretreated teams cell granted preclinical Zynlonta to lines DLBCL stem with am broad with accelerated or are our difficult-to-treat prior large a momentum refractory patients B-cell lymphoma, not patients population trial X who at disease, patients therapy priority you, by pleased energized patients trial transplant the based B-cell clinical and relapsed/refractory therapy. of CAR-T on eager included relapsed II the first truly therapy. following point patients approval open-label prior Thank including of XXX multicenter, single-arm, of trial of who and a diffuse on all The therapy, key with refractory differentiation a systemic first-line label. for spectrum lines had that treatment offers enrolled option differentiated prior of to and broad also patients. very of this

opportunity Zynlonta addressable earlier As population we in into treatment and of to for expand the are Chris lines mentioned, the additional patient exploring histologies.

all or of and large trial supplemental is showed mantle II in efficacy DLBCL Interim this patients Phase patients First XX% a is with overall intended BLA. an portion from Phase relapsed or lymphoma, patients. data non-GCB diffuse trial ibrutinib with to response toxicity the combination our which ongoing and of with B-cell pivotal submission manageable XX% of encouraging the rate support in I Zynlonta across for refractory cell of LOTIS-X

this trial to second enrollment II expect the data We the quarter this in Phase additional year. portion I report to of half second from and of the in complete Phase

also our have confirmatory transplant. B-cell therapy for we who LOTIS-X supplemental are is LOTIS-X eligible trial ongoing stem BLA combination Next, in of a diffuse clinical patients not Phase to relapsed for refractory Zynlonta filing a for intended Zynlonta support with or as cell rituximab. III large second-line

We expect safety the year. second to of of in lead-in portion this half the complete trial the

trials Zynlonta also initiate intend to We this year. several additional

Phase we trial in to clinical First, coming the of start half pivotal in XXXX. the follicular lymphoma weeks a in second plan II

We lymphoma Zynlonta study multiple combinations R-CHOP non-Hodgkin Zynlonta and with in B-cell combination trial first-line of in in initiate also plan DLBCL. dose-finding to of in the

Zynlonta early expansion will the non-Hodgkin lines trials therapy explore of All of B-cell across of these lymphoma. in

both our second completed Moving We with solid trial programs. patients in to made our have lymphoma our in pivotal Cami, progress across II Hodgkin or tumor program, Phase relapsed enrollment and we in BLA submission FDA Updated from lymphoma. refractory trial results lymphoma. and an this Hodgkin relapsed refractory interim quarter, second we support expected or the are Hodgkin for trial to this expect

advanced we Cami in In trial an addition to ongoing patients with tumors. Hodgkin pembrolizumab have solid Phase lymphoma our escalation program, with in dose Ib combination of

tumors, the to monotherapy in of part are trial from in sharing Phase preclinical that further development the look and data data I and the future. data biomarker by we encouraged and support pharmacokinetic this forward more solid We

is more also to technology program, I of with of solid treatment the highlighted in Cami explored just platform in our tumors. excited After the our tumors. the ADCs ADC we validation Zynlonta, As for are various of even solid potential our being approval explore of

addition asset advanced targeting and cancer. tumors first-in-class cancer high unmet with includes a Cami, novel, treatment platinum-resistant with needs. patients triple-negative ADCT-XXX, medical In of for ovarian the solid KAAGX, is to breast This

file We an and quarter enter the expect shortly thereafter. clinic to in IND the second

is Phase in XXXX. pancreas, in in prostate, We solid asset now of first tumors and is Ib AXL tumors glioma to study half initiate many as such AXL, combination overexpressed another promising a breast, Next, as expect ADCT-XXX, lung, targeting esophageal. multiple solid the

enroll to or in In have Anderson. turn update. program, Phase finally, clinical-stage with to relapsed the patients also for we a acute I/II to targeting development. robust preclinical in I continues And a leukemia additional R&D CDXX, pipeline financial refractory X will call addition, our Jenn over programs give lymphoblastic that, With trial at MD last ADCT-XXX, a

Jennifer Creel

everyone. you, Thank morning, good Jay, and

equivalents release, $XXX million cash we $XXX of XXXX. as to reported approximately in of million December our and cash As first quarter the XX, ended with approximately we as compared press

We Deerfield for approximately We will upon million contingent which near the drawing facility quarter. was $XX also another million in our operating cash first Zynlonta approval. activities net in from be $XX used disbursement the future, in down

as primarily support to due We hired affairs for Sales clinical million marketing R&D expect in reflects ongoing compared organization million for the primarily launch due should expenses were we XXXX. our during to QX, $XX and of to increase expenses expenses slightly other year. now million was medical growth million being were the The build-out level The this our off our the to prelaunch Zynlonta of later multiple full quarter activities preparation organization for in of the also spend The clinical sales and compared marketing R&D the organization XXXX. continue a BLA same mode for fully to first investments for of increased $XX are G&A XXXX. $XX company. initiating programs. was and trials. of compared submission, new With commercial and compensation XXXX in the spend $XX our increase to the quarter for and quarter commercial the same million million the quarter increase of were multiple the Zynlonta. the of our $X public of first launch in $X quarter cost share-based increase quarter and expense to first to

associated Our loss with included was the of the loss of loss for quarter compared for $XX million Deerfield. $XX million loss compensation first of share-based under fair XXXX. also derivatives $XX XXXX. of a net credit for million a first $XX noncash the with net changes in of facility loans the to reflects quarter convertible to expense gain the quarter related The first value convertible million net Net the

XXXX per to net the Our loss diluted in quarter loss XXXX. quarter $X.XX $X.XX of of in compared net was the first of a share first

quarter and quarter The call loss certain Deerfield to by expense. to for with $X.XX net The net the the loss net the adjusted Finally, million net the associated increase adjusted the for our in per portfolio loss items back share quarter adjusted that, for launch net anticipated for preparation compensation convertible loan adjusted XXXX. of Chris share-based the was Chris? the same a XXXX in compared primarily of same for compared in excludes $X.XX first was $XX will turn The and was $XX adjusted XXXX. of driven of to remarks. loss million an the loss I With expanded diluted investment the loss quarter closing Zynlonta. the of of

Christopher Martin

been the time Jennifer. Thank of Jay This history and transformational has a Jenn, ADCT. in you,

our forward coming milestones, to team pleased the from we the objectives progress quarters. achieve now the highlights call I look patients launch next the We help are in your as to many our growth. anticipated to that we Zynlonta positioned the development and of to phase updating possible This as and questions. our We reviewed our of next-generation brought enter earlier. are Operator? slide well you eager to open pipeline to I'm Jay as on to ADCs. benefit our which rich patients, congratulate

Operator

Instructions]. [Operator

from question Our Morgan first comes from Matthew Harrison Stanley.

Zhen Zeng

This for Congrats on on the is Zhen Matthew. progress.

couple of a have questions. We

The you maybe other versus on how general first in safety its approvals? one is, comment And Zynlonta do you of could see recent the profile position? DLBCL

Christopher Martin

Jay?

Jay Feingold

sure. you question. Thank Yes, for the

think answer, not trials. of I difficult are comparator to a question. It's So these since that's good course,

you did I that the effusions, very well and design was few rate in edema. neutropenia, in those were So me, therapy the The to less about XX reported led kilogram manageable. before treatment-related excuse XXX of when the X demonstrated about products. were discontinued Zynlonta other had low managed. very think that micrograms the which been than X%. who general, was from or approved say, in a for we more of very than give conversation. patients kilogram. dose our events for discontinuation There febrile mandated recently than micrograms start to has trial caveat dose of We were XX%, by almost delays that actually should trial adverse is have to of was there events that the I per X no trial per that we view profile But that, during weeks adverse dose reductions, other demonstrated, toxicity But I that went Lonca decrease We some

is profile very in that use any is and the we forward So toxicity to we that manageable not put be very strong the will and barrier believe community.

Zhen Zeng

Could then guidelines is that? implications comment you see do potential? you the And in Okay. of on what maybe the potential of NCCN terms use

Christopher Martin

do take Jennifer, that? to want you

Jennifer Herron

Yes, and certainly. for Thanks, question. Chris, thanks the

on the NCCN treatment NCCN team believe submitting patients. swift proud same that In FDA timely of very the day also of guidelines, their differentiated the the of for with the unmet need Well, the the response We're medical we're equally request high update pleased. profile reflective approval on ADC these happy one, terms Therapeutics is the at really XX. from guidelines for and as and first, guideline of April Zynlonta

with also with quickly very the FDA our how NCCN patients that the indication. so recognized happy benefited And consistent very population we're happy Zynlonta We're broad NCCN the of has worked. who has from

to imperatives the us guidelines benefit initiatives that early may the that Zynlonta So the differentiated as since our the in patients NCCN And access access to ensure do we think opportunity success, treatment that critical have our from who year. allow is inclusion one access believe and will so. of Zynlonta accelerate the of our to through uptake open well our facilitate launch profile launch as we will

Operator

Ahmad next from Tazeen of Bank Our comes America. from question

Tazeen Ahmad

solid solid we talk And wanted maybe, the study the tumor most about hopeful effect would little that you At what I on this from side to you can a at to about Cami. about indications point, you bit focus it can GBS? tumors. specifically your be data talk for potentially Jay, then relates as a what to should bit you view think to And do little ASCO. profile see expect Cami in

Christopher Martin

Thank you, can that? Tazeen. take you Jay,

Jay Feingold

I answer can Sure. questions. those

think at not ASCO poster. It's trial I providing. in So a we're progress

phase, escalation don't in because presented So we're data. of enrolled the patients. anywhere trial We've is going we're still We have well. trial number published but dose not specific we pretty from or along data that providing a yet the

yet. And future, on time for we'll I in given but have line some so hopefully, information that haven't more any that the

to think related that Tazeen? the correct, Cami other question Was I and your syndrome. was Guillain-Barre

Tazeen Ahmad

do profile GBS. the specifically just then most solid in you about? feel the encouraged tumor What general, And space indications on

Jay Feingold

Sure.

Sorry, I middle question the there. missed

which using is So literature determine commonly to most by infiltrated solid T-cells. information tumor the we're

too across now We what We think wouldn't on certain haven't name we early have just information be. it's up types I escalation, so end enrolling focused the if kind still specific we're but don't focusing board. dose in tumor to specific tumor yet surprise enough types, It those because me might yet. of on

early. side it's solid In terms in study, tumor the of effect really the again, profile,

tolerated dose. reached maximum not have the We

anything uncommon and dose GBS only time. not that may patients. believe information as either. with we GBS And polyradiculopathy. we association, Hodgkin lymphoma see case in at We of seen XXX you We to monitor saw GBS of And seen occasional as and consistent discussed been or there's what in lymphoma than you polyradiculopathy with and know, recall, We Hodgkin of we Phase of treated correlation we're polyradiculopathy ASH we've And Hodgkin cases autoimmune or lymphoma in have disease that in we've seen that course, never in What at Cami Phase the haven't trial the with so. GBS of back lymphoma, now seeing escalation Hodgkin a the this what is in I is toxicity. terms do any with the and more we've patients related a monotherapy what GBS tumors in trial. solid see II with neuro unexpected. December in trial didn't we And don't

Operator

presenters, questions And in comments. show no will Instructions]. for closing I further to turn queue. it I you [Operator back

Christopher Martin

updated forward Thank for you, you. keeping on our today. you the call We progress. look everyone, Thank joining to

say Goodbye. you. take care. day And Thank a nice so I'll and have

Operator

today's ladies you you, concludes call. your for This and Thank conference Thank gentlemen. participation.

may You now disconnect.

ADC Therapeutics (ADCT) 9 May 212021 Q1 Earnings call transcript