SGEN - Earnings call transcript Q1 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, and welcome to the Seagen First Quarter 2022 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Mr. Siegall. Clay sir. ahead, go Please,

Peggy Pinkston

Romp, with you, operator, welcome results I'm to are press afternoon, call. release that and supporting and to Seagen's good slides be Commercial section, release Simpson, and President Chief a and you issued Officer; financial on Todd the our afternoon, Presentations Chief everyone. Speakers Siegall, website results, first Investors Medical in President, on and This Clay page. Financial press pleased available we Executive Officer; Roger Dansey, Chip Chief and U.S.; Events Thank today's Vice our quarter conference call will Officer. XXXX Executive

risks you the to to question yourself everyone our will outlook, company's remarks, and to today. Securities to Form to an and year Factors, turn under difficulty call materially faced regulatory in Report give milestones, and developments pandemic revenues the or Following statements over regulatory development associated information anticipated statements. in forward-looking participate to by call or the COVID-XX filed opportunity Exchange conference approvals. marketing these and call the Clay. reimbursement questions, and the and for call clinical include events that subsequent and SEC. future hour and the our legal line forward-looking keep we'll uncertainty Q&A with regarding limit XXXX, this sales, Today's reports caption readouts, now, Factors financial we with developments that potential include ended the Seagen during uncertainties may aim open the future one XX-K and one in forecasting company's prepared differ More And in to filed projected legal process. or and ask sales, with Annual the the Actual included the and a with matters related including expenses, implied the for I'll XX, is may Commission to contained Risk results, XXXX costs the expenses, results about from revenues, submissions company's such impacts cause and approval anticipated those potential and and and regulatory the including related December data so on product pharmaceutical disputes difference

Clay Siegall

Thank welcome our you, quarter Good Peg. afternoon, everyone, to and first call.

sales growth brands. are pleased quarter. growth the million of This This $XXX of total commercial net first year. product quarter sales report of product XX% all revenues first We over to last includes across $XXX million, for the strong reflects representing

look we two we continued develop and deliver therapies, innovation As to transformative remain strategic on focused priorities.

accelerated is future support first performance for this our our EV-XXX previously partnerships. trial, had treated the an limited This working Earlier Our label the Pacific treated the have and the impressive take month, and development commercial anticipated which to We data, PADCEV's reimbursement and of through clinical has to Canada, across with EV-XXX PADCEV, care with previously can urothelial Israel the become Asia a year, of the begin I'll Switzerland, global metastatic therapy. with of and options US, data which support also Americas. programs, the KEYTRUDA priority the other with standard Astellas US of robust this progress cancer offering approval strategic expansions, products potential urothelial year. EV-XXX cohort spans designed along clinical cancer. while which maximize are to with in leveraging next are program survival development engaging to potentially for for half the PADCEV, country urothelial approvals in our authorities approvals first-line for robust the notably in in approval monotherapy submissions We previously Japan years, patients UK secured important for in from lines poor depending the on up K or survival PADCEV who two in cancer. partner, regulatory regions are based combinations rates. second in benefit. to The metastatic trial EU both country. continue milestone locally and in and marks treatment we individual and these secured metastatic previously advanced patients secure Astellas, could on and overall US earlier

in These bladder evaluating and also this unmet in survival of significant TUKYSA muscle results quarter, with and for challenges second and invasive the patient non-muscle in treatment metastasis. invasive with patients important TUKYSA's although competitive are become reflect We monotherapy guidelines cancer TUKYSA expect without key populations. Overall factored exceptional cancer in guidance. brain which addressable need to the continue delivered HERX-positive US later-line we into are year, strong inclusion breast combination option treatment large of value. data disease. KEYTRUDA in represent our as has an this PADCEV areas and in annual clinical

in could amplified tumors. Data in the from development includes year the cancer, additional Merck reach potentially next support for HERX-expressing colorectal launches or mutant collaboration the in and expected HERX with to Phase XXXX, in half this Americas. working breast program HERX-positive second TUKYSA's Europe trial of broad are are European with other TUKYSA's US accelerated trials cancer. gastric of year X and strategic MOUNTAINEER expanding the We enable cancer and clinical patients is outside and our colorectal cancer, approval

cancer with a metastatic important on reception strong our relatively poor driven cancer clinical differentiated existing medical last is therapies Launched disease ADC TIVDAK represents high an by recurrent collaboration outcomes. historically Genmab, approved population, efficacy. from patients new in data, patient uptake in need tissue September the represents community approved factor US unmet oncologist positive and been commercial with Although and has modest execution. in a colorectal targeted the the a a as limited or offer therapy cervical it for focus

TIVDAK's the care we decade medicine of its Hodgkin frontline globe. peripheral our patients lymphoma. around the will partner, patients. for which maximize Takeda, its approved advancements data a Phase the countries. XX represent to cancer market combination ECHELON-X to and clinical in and presented Roger X in may demonstrate opportunity and cervical lymphoma promising of And cervical these Groundbreaking regulatory are important has larger on ADCETRIS tumors, launch, have program, ADCETRIS lymphoma clinical solid its much We further which regimens first and to diagnosed opportunities. earlier lines development while over after this advanced overall details importance value than T-cell survival in further designed global Hodgkin of future data supporting More in in and standard continue cancer, from newly other US now therapeutic applications. ADCETRIS provide is bring been trial

Hodgkin In lymphoma. be Phase a and study in the addition, for FDA event-free to and patients X improvement in group this demonstrated X Phase the June children's pediatric pediatric data ASCO will will ECHELON-X year. high-risk Both data be submitted an at oncology survival presented with

development Lastly, the progressing comprehensive a potential maximize we are to program benefit clinical to patients. for ADCETRIS

is solid our late-stage to diverse that priority look market strategic we novel drugs deep of broad DV our HERX-expressing as tumors to is to or years. across additional second utilizes a pipeline ADC and internalization. is vedotin-based active in DV technology. a bring advance demonstrates Disitamab coming rapid Our and range vedotin the

support other previously treated breast, intended approaches and accelerated monotherapy trial recently prioritizes urothelial combination and program development metastatic cancer the clinical gastric, bladder, approval to in US. in We cancers. initiated Our in pivotal a

pipeline. earlier-stage to Turning our

ADCs We validated novel are and advancing several to both targets.

and malignancies. four range We Overall, hematologic technology. sugar-engineered use also of in our across and tumors than programs more have progressing that programs solid we proprietary a products antibody XX pipeline are our

that Our the GlaxoSmithKline the collaborators relapsed progress approval AbbVie ADC programs commercializing data are our several frontline making was ADC, for recommended recently based CHMP is European Commission lymphoma. and therapies utilize clinical lung for breakthrough on also combination Polivy myeloma other that vedotin cancer. in Roche is multiple non-small B-cell patients important granted designation cell And large with reported with for Phase X with advancing telicituzumab effused for technology. their for study BLENREP therapy from cMET anticancer trials.

to pipeline the our and products, our deep As future, footprint. to expanding commercial our upon geographic building plan and we is advancing diverse our look four continue

over to innovation are debt, including lives the XX Sanofi. recent with cash collaboration approximately today cutting-edge position on positive people of our to have positioned on make a We we of with $X and tomorrow. our no cancer and impact strategic strongly utilize partnerships, Based billion

financial Next, pipeline. detail will I'll discuss Then Chip turn our our provide the results. will Roger and will commercial an update on call development over Todd, to activities Todd? that, who After our performance. clinical

Todd Simpson

first quarter the call quarter over net joining in was million Thanks, our first quarter quarter, for thanks $XXX are clinical another of which of this trial an sales increase afternoon. our everyone for last a to in million reflects representing Clay year. company This sales $X of summarize growth XXXX. aligned the XXXX XX% the of guidance. of were business. first with briefly product they into by and I'll Total was financial factored XXXX, combination driven included XX% to the across significant This progress revenues our are million, conducting expectations on that which us over and also results $XXX the and included for the

the and from third slightly contributions ADCETRIS $XX These by XXXX. the US by outside first launched our compared first revenues was of Canada quarter increased by and XXXX Royalty fourth royalties sales Blenrep royalties sales degree, in Takeda, of approved quarter drug. GSK. product to driven a first to from XXXX lesser quarter quarter of which of TIVDAK, of the primarily and Roche are Polivy million XXXX by Additionally, to included in by the as sales

as the quarter well revenues. profit from sales to XXXX. Collaboration and other on the activities. under some in These by first As payment create of an from from Japan of contribution the each degree of of This fourth collaboration upfront Sanofi ranges were last March, variability PADCEV year each its decreased sales in the the paid a collaboration our collaboration at share resets year ADCETRIS expected, of quarter signed included of mid-XXs. royalties the revenues royalty in quarterly as as from in our mid-teens new rate million beginning $XX Takeda Astellas'

pipeline begin Astellas non-cash profit approval sales of EU, our for costs This $XX TUKYSA. from and partners, included first million as sales to million deep for approved recent $XXX expenses XXXX. PADCEV in we of products expenses the potential expect our diverse amounts our of in Cost quarter of of of $XXX This SG&A share maximize our US This Genmab, of to brands, well and PADCEV sales the TUKYSA, in royalties the and to of support of the commercialization next across driven and by collaboration launches pipeline reflected million. technology well XXXX. increased continued as investment the Europe. to programs. amortization increased investments the acquired product cost increased profit PADCEV first our quarter to to R&D first reporting as launch share country XXXX as across ADCETRIS, the by to quarter the four each year TUKYSA Following is and TIVDAK of ongoing for of efforts of amounts the Astellas. in

strong in our and to our start XXXX guidance pleased are we February. off a are we with maintaining in With mind, results. provided We that that financial financial

Now I will additional outlook. our provide commercial will the pass details who call performance and Chip, over on to

Chip Romp

and Thank first provide over set I'm on increase $XXX XXXX. quarter quarterly first which million the a our four commercial XX% pleased were PADCEV approved quarter covers $XXX a million, Todd. of brands. sales record you, performance, update an to of new

the supplier, growth first trial million up was Excluding over quarter of clinical last XX% the year. $X

starting X.X in market, potential the the the We PADCEV post US During of into US frontline checkpoint years forward in the expansion patients look standard XXXX. novel care setting. a its the label in in to became new setting first on

patients. EU We bring to and approval excited in this forward working PADCEV's recent with collaborator, are Astellas, therapy also to important by look our the and UK to

on Moving to the TUKYSA.

$XX million, quarter XXXX. over a first the were increase sales XX% quarter First of

in approval how regimens sequenced, third is and these the this and HERX setting, a continue less from that expectation competitive You in remains only inclusion where the will increased pathways. into in our setting, seeing delaying with the guidelines With a anticipate in plus our TUKYSA, in XXXX the used. anticipated shift line our of for first recall in impact TUKYSA setting, modest patient and launch second-line This quarter. despite mostly HERX's to HERX's TUKYSA assumes outlook we impact use pressure are US flow of

over involvement. $XXX the look first the first Sales from in efforts the promotional first were XXXX. especially additional we increase reimbursement year. And XX% the dataset TUKYSA's top is continued moving focused data on ECHELON-X for has and quarter, driving million were to we grow CNS line ADCETRIS those sales value forward overall proposition, an million, strong ASCO. in after The well look sales presentation to and TIVDAK Europe to Our data with gaining patients quarter trial. team quarter positive countries in received awareness in this in been oral the February, announced The at of full quarter. survival the $XX a forward of finally,

reception this treatment important indication we new opportunity, for is patients positive with and initial from the While this a are modest option. pleased physicians

to Now I'll hand Roger. the call over

Roger Dansey

Thank the you, with advantage in survival EU I'm Chip, share medicines clinical based PADCEV, its very and treated pleased development previously Beginning and the and was long-term recent good to on our at are in the ASCO, and frontline happy a In patients metastatic in on based we studies. This recent afternoon, analysis, overall KEYTRUDA update metastatic trial. everyone. EV-XXX with we to on approval of the our approved at UK with prespecified a evaluating XX outcomes the are follow-up. combination in plan months the demonstrated as cancer an of important setting, two we and interim study PADCEV present urothelial positive additional pipeline.

K, patients are enrolled cisplatin who which ineligible The therapy. is EV-XXX study first for Cohort

the both includes global enrollment The track eligible and cisplatin which III on trial, year. Phase is ineligible patients second is this EV-XXX to and complete

models monotherapy are bladder Merck, trials testing As to At the as monotherapy trial administered Phase we MIBC The advancing a understanding PADCEV EV-XXX the with is minimal as combination we cancer. of together bladder in patients. single-agent systemic data intravesically intravesical showing data neoadjuvant in At non-muscle patients. are Astellas GU is These PADCEV other PADCEV activity. III I earlier of we assess invasive cancer, and who month, One in the efforts this ongoing nonresponsive in muscle BCG treatment. of no context evidence usage trial local are combination PADCEV data perioperative and for setting promising with meeting along meeting, presented people progressing look in of to in we are the of AACR the preclinical with presented cisplatin-eligible KEYTRUDA we trials. and PADCEV ASCO patients NMIBC, impact our in suspected ineligible. toxicities, the recent invasive important cisplatin-ineligible in Phase investigating in Furthermore, antitumor the two

monotherapy expressing PADCEV tumors. trial bladder cancer, Beyond we a Nectin-X continue of basket assess to in solid other

at patient that and CLIMB-XX. HERX-positive are to the Phase in after the the recently assesses are HERX of as trial evaluating colorectal recently II year. including United Turning confirmatory death HERX-positive in second trial, treatment, expect obtained This relapse trial next randomized the year submissions. cancer. intended excellent Despite also GI accelerated alone Phase previously patients the the with to serve TUKYSA, approval TUKYSA we first-line maintenance with accelerated chemotherapy a MOUNTAINEER United CRC, remain with received study setting future randomized or pleased and the study this in CRC. TUKYSA, to States cancers, brain. This initiated we as States patients frontline trastuzumab approval trastuzumab MOUNTAINEER-XX, of TUKYSA, standard to TUKYSA the potential in for to in chemotherapy metastatic trastuzumab is for TUKYSA therapy. we will for a the metastatic of alone. completion announce treated HERX-positive results first and from the global taxane care global X In trastuzumab If topline results risk This and comparing the of trial support to and half enrolled the combination is treatment of in report pertuzumab risk and the THP, standard In pertuzumab of relapse to Patients component we of breast receive cancer.

in Additionally, we trial combination in a alterations. with are solid studying basket trastuzumab with HERX TUKYSA for tumors

monotherapy and United facilitate TIVDAK. cancer, chemotherapy. intended and global Phase enrolling cervical Moving is on cervical XXX United trial treatment X is with the in TIVDAK received recurrent has to or of The to serve for to or progression in well metastatic after States confirmatory the regulatory in the patients trial accelerated approval with States disease as cancer, the applications. innovaTV on

As we been cancer, combination frontline recurrent earlier at June. TIVDAK to including ASCO move carboplatin without look the present oral with metastatic innovaTV KEYTRUDA lines study with from presentation of to we investigate will cervical expanded trial in The further XXX has this into with or an data combinations, frontline multi-drug KEYTRUDA also bevacizumab. and TIVDAK or

We in evaluating TIVDAK a in including as patients combination of cell neck and patients, now KEYTRUDA to the squamous in combination we innovaTV and the to cervical trial we and Beyond monotherapy turn other is recently in solid TIVDAK XXX platinum-containing frontline chemotherapy neck. of cancer, with the and/or I'll TIVDAK and and monotherapy head the now tumors, with X these in carcinoma ongoing presented study continue setting. chemotherapy. both encouraging expanded cancer explore data KEYTRUDA head have Phase to multiple The study malignancies, ADCETRIS.

diagnosed Phase our ADCETRIS We were presentations pleased Hodgkin that lymphoma two for are X trials of in ASCO. important patients newly selected extremely at

first which of X. with a to was combination p-value significantly X.XX XXX. patients by ADCETRIS ratio the improved overall in lymphoma. hazard The XX%, risk with with compared and ECHELON-X, data AVBD a of reduce advanced survival of with showed death from ADCETRIS shown Hodgkin that is AVD in

X high-risk survival endpoint Hodgkin primary with met a presentation Children's The patients chemotherapy, to of lymphoma. Oncology event-free will second plus regimen compared pediatric be ADCETRIS from AHODXXXX bleomycin. superior chemotherapy its that study data The in Group of Phase the study, three-year includes with

to BLAs submit for two trials the these FDA year. are this We to planning supplemental

cancer. trial monotherapy study, in it results support to the the Turning we States. Phase second-line We potentially enrolling HERX-expressing recently DV. in disitamab approval vedotin, could began United or this positive urothelial accelerated X obtain metastatic now If registrational into from patients

studies breast bladder and to registration in the several next initiate also additional HERX cancer cancer We plan over months. low

We such considering solid other gastric are also HERX-expressing as development tumors in cancer.

mention pipeline. our Now, I'd to like briefly early-stage

vedotin of candidates of range data which endometrial tumors, activity ADC SGNBX-HXV We currently the SGN-ALPV. ovarian robust its limited across number hematologic across including activity with ADC checkpoint cancer in on tumor of expression. malignancies. normal evaluating immunomodulatory is immune Earlier our is growing trials the promising Phase clinical detailed presented the We drug this expressed through a AACR, and antitumor ADC programs, two are BXHX, death. preclinical induction a at we month and breast, SGN-BXHXV solid a and newest stage targeting tumors X of immunogenic clinical cell and of other

pre-clinical activity We ADC the also a vedotin including Phase Clay. in now of will non-small first antitumor recently ADCs. ovarian, disclosed two cell expressed hand the the alkaline phosphatases, trials of which across and endometrial, solid targeting SGN-ALPV, over novel We central X tumors, cancer. lung I gastric call these patients enrolled are to

Clay Siegall

Thank you, Roger.

an past ongoing we A intend this of now the Enhertu against With engaged proceedings representing would royalty legal review US with to November an expiry Separately, I Office granted arbitration turn to jury which Enhertu certain request verdict, United patent this vigorously to on sales Q&A, the a costs. damages awarded of rehearing one of comment Daiichi and royalty future other post-grant court related year. intend Before to that Enhertu through the ADC on we were patent, claims decision matter, on technology Sankyo proceedings and on and $XX.X we recently instituted product as well future court anticipate the a of our as defend. Trademark request States. in US Daiichi fees of X% Sankyo million, XXXX willfully patents ownership Daiichi a in certain the In of later royalty Patent We over the we with candidates. enhanced on sales in several found out like from are attorney in used against We that same infringed two our a Sankyo. US damages, and the Enhertu. of

for important in intellectual many decision patients in a and advances for mid-XXXX. transformative as the in need. property across milestones that, important closing, drive clinical ADC therapies Operator, We to line our data the to arbitration Q&A. develop groundbreaking readouts, and With for global progress on we we'll including for us It's expect and In defend we expect please important continue our XXXX, open to achieve questions. commercial your pipeline. open innovation

Operator

you. Thank

question begin ahead. [Operator question-and-answer We Cory will the And come will Please now from with session. JPMorgan. first Instructions] Kasimov the go

Cory Kasimov

ask guys good Thanks I and afternoon. TUKYSA. to about wanted Great.

implies So million have a $XX given in per $XX nice it quarter. it after QX. here, $XX the just million over balance quarter the prevailing about of the year guidance over And of just the million, you I average think

you So met you expectation a in much until is I'm just dynamics with that out you. takes the see conservatism Thank versus how and quickly Enhertu comes lot market see the stage non-brain shaking curious, start at guidance this Enhertu patients. how prudent of in share an

Clay Siegall

not the proud new Cory, yet. Enhertu really thanks approvals any as seen for of TUKYSA, and call. We're have on know we you

what Our assumption later and exactly you non-brain perhaps this year, especially approval on of guidance the meds, -- includes said. an soon an impact the an

I happens wanting So, this see asked, are you what to year. think later we

that think right. exactly I

about I I what of it that a lot guidance. this make being and think We -- very in -- want point we happen don't makes ways. think comments said change at we're right you now, the things to any a provided But to sense. we it's makes if sense additional very and think guidance I you certain will, certainly do that? Todd, transparent

Todd Simpson

And Sure. happy to. Thanks, I'm for Cory, question. the

in this with guidelines. is We think might TUKYSA that bit were you label, TUKYSA Enhertu, a they've year, I tough as one. current So, on We're in PDUFA the we Cory, the of got in little know guide already seeing great a a but May. imagine, them doing

forward, later of may in that the TUKYSA line create and moves is sequencing little of active think patients. therapy. for approved, drug drug a push is a gets these how bit in in Enhertu market, change will the We and drug it patients a this as used a into reaches are great very as So, that drugs

our guidance feel very is And So our we that guidance. into good. assumption like built don't was

Cory Kasimov

Okay. Thank you guys.

Operator

with Sachs. question come from will Richter Salveen next go ahead. The Please Goldman

Salveen Richter

meaningful Thanks K what KEYTRUDA Heading the frame you for is ORR taking question. my just cohort clinically given that in could population? data, into activity expectations on

Clay Siegall

So, as can you the here's thank trials, we with some And working, the rest question get address our and say, Roger opportunity here's K Salveen. very of for them the Where of are excited trials global cohort we're are about question, you we PADCEV and that bar, but he to specific, to outlined see try know. this what we and like what need after. a haven't can a

So, be But I best provide bar try the FDA. since day, at to to we up to know Roger the them. can't the to will It's really, it's exact. do end to it's here's color. would say, the the remiss understand, FDA's really of we And be up

Roger Dansey

Thanks Clay. Exactly.

Just enrolled, terms patients they add the we've some that cisplatin-ineligible. more of to commentary, are in

be potentially the somewhere carboplatin, you the expected look that response would in to treated regimen, rate is be at mid-XXs. so And closest regimen. the a can And population with population a carboplatin-based for

status. with the data A, response later of sort KEYTRUDA in monotherapy cis-ineligible a both generated to produced of in initial treatment, we which XX. range depending KEYTRUDA of XX% obviously in of has have PD-LX have of upon XX% of We PADCEV sort was somewhere and cohort PADCEV assessment frontline which the And lines an rate population, responses range. a

end, exactly We'll in right. as to they're numbers, forward take But be buy of relevant I excited what obviously data landscape Clay can you is is. the we have. of the those it's But an in exactly terms all the will the trying understand to what to think So issue review FDA bring be. all

Salveen Richter

Thank you.

Operator

from Andrew SVB. next go Berens with will The ahead. question come Please

Andrew Berens

Hi, QX thanks. in Congrats guys. on the strong execution

especially I data Just when TUKYSA. TUKYSA Is won't of was that see toxicities reason be other that the any think HERX, top we some overlapping. or backbone there with therapies, within may on ENHERTU. effective may wondering to a question on be

Clay Siegall

you thank the We're really excited question. with regards. many in TUKYSA for Andy,

as We diseases. on colorectal cancer. out have few trials a different other quite such in in data And have we coming going

combination on whether with other are to be or Roger I they in comment Roger? ENHERTU think appropriate would things. thoughts

Roger Dansey

Absolutely. Sure.

not payload, that with used So right, in regimen is capecitabine, is cytotoxic Andy, construct cells the agent, the with cytotoxic was the together of so ENHERTU, of is principle, conceptually, the chemotherapy together which tucatinib. which on plus the pathway castuzumab from plan different inhibition was effects ENHERTU in trastuzumab that

So own well-tolerated as sort really regard has profile. agent, as attribute. We're a a for that ENHERTU have agent, combination each of drug an of single toxicity, with the be With Tucatinib, its important right could in efficacy. obviously, years. that extrapolate first very to fact, is is may can some a together principles, and one TUKYSA data And interesting now. taken generating

what So HERX look medically important we combination. these suffice I are combination potentially winning that agents interested on be can't comment recently two if on active because the will the profiles like. But landscape. to And the in say, are understand most meaningful it's may to there

Andrew Berens

some data? see might when the Any Okay. of sense we

Roger Dansey

center, and we've indication what timing enrolling given the as of would that be. to data we're generating not any We're

Andrew Berens

Okay. Thank you.

Operator

from The Guggenheim. Schmidt next question will Michael Please with go come ahead.

Michael Schmidt

particular for started on us clinically arms, monotherapy? be is of Thanks. for if duration will setting? assuming two And question. a what And is combination versus Is the is Thanks meaningful on there a obviously, I the there succeed Congrats response it? I'm taking way my I study both that correct could important quarter. and guys. Perhaps follow-up about the of comparison response on response rate, thinking understand on endpoint. arms understand that help hurdle the that? of you then your comments for EV-XXX Thanks Hey, cohort in a rate. K. another this the duration had has

Clay Siegall

in ourselves not about, pride looking I'm but to up our duration. ask Duration good, products you durable, patients Michael, that forget their cancer life. to that sure not you is that making we all it's and glad a rate but on with question duration difference it's meaningful thank Because they're brought sometimes patients. in important And response if make for the something drugs. investors a really for cancer in Hey, making at and have this. looks you so that important

FDA and arms at important and also the is endpoint Roger, trial? talk about that you to Duration-of-Response or can we bit a little the of acutely. DOR the so, And them know

Roger Dansey

great a Yes, Sure. question.

So, PD-X durability response inhibitor of one enormous hallmarks as from brings And as a of of durability perspective, value such pembrolizumab, is something obviously, it like a the hallmark a of [indiscernible]. immunotherapy. really

contemporaneously we could see setup need directly to these is The in value But are of clearly principles, believe in something expect reason it It's to We of durability, need duration data probably compare. but be of see of individual that from patients. months would we looks is with The K. will median stand favorable. data. the generated that a have to randomized the the as and understand that long, components. is there is or very monotherapy specific look response one therapy, it monotherapy dataset that to the seven more chemotherapy, But present and basically PADCEV main certainly order no – in well. Cohort than Cohort the we understand A from every longer of by somewhere On But which obviously, itself which at durability. first contribution PADCEV thereabouts. trial, the to that We favorable,

or to look make had obviously, PADCEV the it, at out that of quality we nature can so – when the judgments and can we've of durability monotherapy. we And as and data

Michael Schmidt

you. Okay, Thank great.

Operator

from come will Morgan ahead. question next The with Stanley. go Harrison Matthew Please

Unidentified Analyst

Steve asking Hi. It's for Matthew.

DV. my is So, about the question

I differentiation part to low Thank see front? breast and So why this ask are want this you what do cancer. Enhertu you you that I compared in you. see pursuing the because to that HERX

Clay Siegall

for DV. question Thanks Well, on hi. the

about name like that one use Enhertu. and the in of same And the trastuzumab. is So, we for Kadcyla the is is name generic things -- Trastuzumab it Herceptin. antibody DV really doesn't

the internalization rate that's very that. We DV that And of has a rapid we've more internalization, that we know And studied know the in antibody. antibody so much rapid.

And to antibody an we think drug so, that's attribute that conjugate.

So we're also in product. excited in works And to seen that data patients data already for PD-Xs, that's seen in and HERX. combination with that exciting HERX know we've We've DV have that low that. we –

compelling we'll see also that I've to work think because the with ADCs seem combination date vedotin PD-Xs. in we I've our the with not containing molecule containing that, shown the camptothecin-type data the that they of don't And camptothecin so, as PD-X. is in data But Perhaps seen other have ADCs seen future. with well as differentiating to ADC, that's yet some

the that ADCs single on And think differentiating trastuzumab with So to versus the second the or targeted thing core agent, for we two a combination HERX market. potentially rapid differentiating. also is the the as PD-X the antibody internalization is

us I that is this excitement think give product. differentiated those So a

Operator

with ahead. The will go next come Please of from Meacham America. Geoff Bank question

Unidentified Analyst

for our Geoff. is This on Hi. for Thanks question. Greg taking

is different how peaks ex-US relative comparison the two. ADCETRIS Obviously, commercial an here? economics to But the is differences any and the instructive peak, between their about you are are sales that you respective thinking And to seen in So TUKYSA in the PADCEV do US? and we've US, there see opportunities? what dynamics relative

Clay Siegall

good to These questions. to I out point question. trying to your things Thanks. are few a critical really that address do want are

and and the gaining Astellas. are we all, TUKYSA that country-by-country of territory prosecuting lead First where Europe, sales and in that they to had trying we're their charge. force, reimbursement. own our our get approvals PADCEV many working it's And is with partner, something we Europe, in

So we those the the there. to outside We I force Takeda. and just up set with lead for drugs. different we Canada, rules commercial sales marketing. ADCETRIS, the dynamics that charge love leave charge PADCEV. the US the wanted Astellas And ground in we With both dynamics, and US, TUKYSA, it's so leads the Europe have in

and of So and territory what drugs it. on with and partner how differences depending or there's each do what these commercialize it we

they're it opportunities drugs. And these And reason drugs borders from about know countries around and And to is as are. they patients. This drugs these are strong And drug, where doesn't the our strong. matter very boundaries bring know, excited in benefit patients. don't good because you is can it, If they our so to cancer and the these drugs globe politics. the we for want and are we're about

opportunity So have experience a the something lot ex-US for ADCETRIS we is with. more

bit of And end well. the opportunity actually the economically and a we speaking? the that kind brought done of has your up look what at difference ex-US at could about for Todd talk you question. little are how You ADCETRIS

Todd Simpson

bit first yes. I -- yeah, a you me, would could let So, about so say little

sales PADCEV right, me for in booked we the first it's for Europe, TUKYSA sales in let say share So a Clay's with profit and Europe.

expand is, one the populations. Number off different drug noting. when two subsequent you then launches little set a think launch different. patient Europe, in look So the a to the worth bit And that moves? it's you in with drug, in versus would US, you treatment a In Europe, are and probably labels, there, your price rise you I are in at starting launches general, US say, there drug I things

But negotiating price in negotiate approval in and you launch. price. call you're and before country for launch commercially provisional other can market throughout to different You of Europe, can while Germany, you're like you markets have countries kind country to to some your negotiate different to it. I markets it then you a allowed get a the with, France price need go by you In for access names

markets, our So, tends it how little slower to these to because be US have what the does impediments getting don't to focus which reaches in With the Obviously, efforts want in to peak Europe, It Europe launch the that to trajectory? you and key need do market. spread negotiate you tends we you your out. than it a in things slows have that is initial to to down. to what done. try country-by-country,

guess, US The prices element other, than typically, out I are is would prices. that point European I lower

your is down. general labels, also, US number And to same the the get patients go to to the different tends one. So, at different. then number Europe, you tends launch additional That's typically, the And for Europe. the of be market while then may you be number and price in as which in there Europe pricing in two, rate

Unidentified Analyst

Got Thanks lot. it. Super helpful. a

Operator

Wang next The Barclays. ahead. from with will go come Please question Gena

Gena Wang

you. Thank

regarding question sales mentioned one jury should positive, from X% Just And the to verdict? the we past also, the arbitration similar decision. range also November be royalty expect a in for we I the expect royalty XXXX? If should until

Clay Siegall

that too patent question. as that not we ruling glad the for I'm thank one really on been infringement. that the distant hope there's something the already gets resolved court you Gena, future So you asked in this question. It's

So, let's your address questions.

infringement. patent the with start Let's

and also So, you upon. was about. was previous the was what us in jury sales, is which ruled had that's sales awarded public was for as asked to a X%, and That you jury that's there, something and willful that the infringement, decide it. mentioned, know Previous that record

for up the until basically of of XXXX, underlying that's brought the that's case The was infringed. you being so patent rest to that the And and the infringement. court November of it patent time

-- forward I'm the lawyer, that infringement we the and the work that you and a in patent we the provide you judge have end of the royalty patent with judge life. legal provide to request going a not -- request you information you things And judge to So, case. and is with but till this

infringement, Now, this not is arbitration. still on the the patent

to don't I what anyone want confused. So, will And get decide royalty judge is. the the

I is jury think look potentially could you the that but the the to decided that judge. on X% it's historic something at, up

or I judge. It's begin up same. really higher the say the whether the want lower, do to don't to to So, judge will

your second is thing second the arbitration. The of -- question and part the

nine about issues employ to technology is almost working years and together Daiichi with of teaching our had all that them them on contractual how Sankyo it. and ADC that based Now, our on with we based

each be included you any molecule of usually that be what so have molecule they most subject is patent the And subject those And unique of subject is then technology, is you if molecules not end do companies, molecule. specific the What patent that include that we underlying would life this our believe by will is linker. to any do, patent. we And not will. to contractually -- it would

pick patent say, what our to arbitration through is date. they that judge number lives have the judge if times. the a that And just pick our molecule outcomes that will and royalties. they since for There XXXX don't same technology. patent could made Then for molecules they if we're different royalties some a be we value do new that the sales. a to want wants time And I to let's there life range or quite So because XXXX, of of value. were new times The using exact molecule whatever of asking judge value using don't that arbitration, system win that have a in thereof patent linker goes are assume the through, the different can determining molecules at

sales, life for it those years based not case-by-case end the Also specific so is molecules talking that those many the be And XXXX of patent we're would which that on more molecules, on because could could based be than determined patent be the the about. it of US basis. on a

is contract global. Our

us, could Does global period be would understanding, a over -- what on it those for substantial into That sales you So sales with you stretch and be hope -- XXXXs, on of for global need could based I molecule. that that that time. provides depending Gena.

Gena Wang

Yes.

So maybe a question. follow-up just

be when make will will who announced be also we would for assets? a royalty And rate, that royalty royalty individual the So the decision each the negotiating then like -- would you the or announce with individual decide decision, about arbitrator rate? the Daiichi

Clay Siegall

the So on question. you I complement Gena, to want

royalty judge. arbitration Seagen it we be made case judge and that and on the can decide type say, want correct. question a and the just the judge judge he a this to arbitrations, but can know cash things, that if it to rule the judge to was the to rate. a cash our The lot I should royalty decision different And determines So make judge I up the don't could could of not answer and of patent it's not on infringement I can there's cash you because do. value But the that judge, because come only or what compliment what decide that's should the or there's

their rule judge the to out molecules linkage So to other and the could in discussions. say, arbitration this judge. and in judge And that's need that Daiichi work Seagen’s. arbitration is also royalty up The the Seagen of ENHERTU inside come to could

that something us. arbitration So it judge up is is to up this in not to the case. It's

Gena Wang

Okay. Thank you.

Operator

ahead. will question Blair. next come Please The William go Hsieh from Andy with

Andy Hsieh

Thanks my Great. question. taking for

very a HERX-targeted is small about in I unique where HERX and franchise, fusion the the you molecule. position So think a ADC related to all have questions

advantage and population. of about same the So I'm the if how just lines, along thinking I Roger share mentioned this you on your strategic amplified muted curious attribute. think could And take to

you're kind if any open sharing of with there curious plans us to of as I'm well. So sort

Clay Siegall

really of through a the on questions. the fact, molecule come you of Roger, combining targeting and really a that important about tyrosine HERX interesting and kinase, thank your that outside franchise we proud that -- is through perhaps of outside through the targeting the do well patients. have delivers antibody other it with we're small our an any ADC, by the cell cell the And, an Andy HERX the could we be the inside And you could had targeting of cancer inside think talk cell attack inside for and the in mechanism HERX antibody, and to Andy, our an at potency cell the then cell, on of populations. questions cell and thoughts and

Roger Dansey

has I already two the question, drugs. generated for China in Thanks already mean, have profile China. right. we activity in Sure, active you're been and Clay. approvals Yes, Andy. that's has an DV

valuable we plans, think, potentially obvious be vedotin specific us where be it's opposite could disclosed program. about development where valuable And DV could the I for but in have for an a think TUKYSA. in to place not any TUKYSA carefully disitamab And direction, so,

It's currently the taking under of of as the out DV data busy basically RemeGen certainly this, come designed program, the consideration. just through. that's reiterate, and thinking would we've off we're those China. is So data things I from building

place going of they traditional to data. it's already have HERX for but an generated cancer, bladder obvious not So, very interesting for a example, go after agent, a sort

a after of for potentially data approval RemeGen. then into open IND, And HERX important population. other So if HERX of the trial, that, product. in we can looking take on that begun is and point from Because already based have accelerated designated as is and something a a and make further going see it's we to what pivotal also that generated the DV, an that's an which turn and think we piece we've low

you public, you levels synergy, two two in those We're multiple two potential just there out excited, lots the to in efficiency for obvious of things are area, products exactly as So so say. excited much same us. of, at sort but will, because the that of is start, if And put are there's have opportunity. we're to sort and places

Andy Hsieh

And on would the sort any you be to of or mutated indications amplified thoughts share strategy? willing and

Roger Dansey

the I with got apologize. away a have about basket we carried two together. Yes, talking I trial running TUKYSA.

come So tumor combination cancer types. so and to mutant cancer, cell different many in across things interested we're, Obvious obviously, lung mind that ones on. very TUKYSA-trastuzumab tract like include non-small biliary

and as DV information, that but can just from two And thinking potentially and we're any combined TUKYSA disclosed assure to agent the generating you as thinking single applied could with all through trastuzumab be approach together. strategic I individual we're a both opportunities, not So as data. clearly, of Again, agents, a type well. perspective, DV we've of the that that possible then

Andy Hsieh

very much. Thank helpful. you That’s so

Operator

will Oppenheimer. Olson with Please, question ahead. next from come Jay go The

Jay Olson

read may the or how trials? comment for And with cancer. then you trial Congrats you the urothelial taking on data the thank prioritizing DV for Can results describe locally types? metastatic that since I other Since and other with potential DV. wanted rationale you tumor HERX-negative just ASCO patients advanced have Thank the urothelial HERX-positive just HERX-negative patients DV quarter. cancer, on X the on to at Hey. in Phase to you. for you up and DV of questions. follow registrational initiated can just behind metastatic you those trial across over And

Clay Siegall

Jay. Sure, Thanks.

interesting drug great well. has in very breakthrough an urothelial is it data. that DV got It's exciting believe I And you remind will I cancer. questions. designation as Just

and that something parts of and want urothelial of and lot a thinking DV to Roger, about do it's question you there's the forward. comment real what rationale other information about go cancer? to So the we're

Roger Dansey

Sure. Yes.

an be needs bladder biological of in may there. potentially. -- cancer, marker. in internalize. expression ADC may a urothelial patients. It's But And of So it's reiterate, a actually HERX just that, It regardless surface what be important to component an number meaningful relevance in is to that's

have IND. And an we as said earlier, already so basically, I

have We we trial a have initiated. breakthrough have we that therapy designation and

as our an think into of therapies we're urothelial step space, unique in from because So else perspective cancer of developing important. obvious a and the cancer much point urothelial to the it's view molecule, pretty in DV from alone that's take I HERX who is

course, exciting. been Secondly, that to has really of generated data the that is

we principle. of so the sort itself, combination We to important regard DV, patients inhibitors. an opportunity. can features With it's potential the Clay with the value potentially to, see the And another cancer. we HERX the product including clinical potential outlined differentiating breast again, bring urothelial as antibody the same cancer, of think with all PD-X that with

thinking details We we But development to that of about you this. haven't will for hopefully, be the plans. understand do, we're when disclosed how our helpful

You being not that what general, I'm entirely to mention expression needs to necessarily again, to data do is did in require to. referring But ADCs say, I just you're tumor. it presented. receptor on principles, clear relevant biologically be that would first internalized. on sort some of the don't require surface receptor All the

low So, HERX just relatively as expression. other molecules populations gone after have with

So way. we the see in same DV

Jay Olson

Great. Thank you.

Operator

JMP ahead. Reni The will come Please Benjamin from go question with Securities. next

Reni Benjamin

one that a greatest a that drive pick provide be could forward? good Thanks if and questions like couple the guys. you advance maybe that's for practice Can overlapped? regarding taking to us feel sleep that how had ASCO, might you shouldn't kind Hey, quarter. at going And of maybe congrats afternoon changes, LV of maybe fit the on evaluation or some you the color and ongoing the the

Clay Siegall

Sure.

asking where I trying on what perhaps And this about little you're schedule, get Merck, a there. patient could want lot We've trial. it had initially and competitive talk -- a make after. than therapy. longer LV taken active exactly best thought there's just have there, a been the to our it to dose bit And active pivotal in know of has best line with an I we consider do trying an regards, But to Roger comment. of we partnered It's selection, excitement studies. to don't first. drug. find could ASCO but and space. is We're seen we combination crowded something So we've a There's single-agent to a

and study, ADCETRIS, And where So survival I'll I'd with adults really have going plot we our and regimen of data. in tremendously is ECHELON-X pediatric tell you lymphoma frontline those work with we an our six-year in if a death. Hodgkin what think and a XX% exciting, patients those we Stage ADCETRIS with X We're -- data reduction it's very you have to This lymphoma. all we risk and study the life Kaplan-Meier is altering, tell categories patients the I -- like near that's to pediatric the you, because which in data. we both have with well. really show The have have is X diseases in Hodgkin

or LV ADCETRIS and on to the the at proud want we're So ASCO? which on to data of going on make patients. comments we're any potential impact you -- that, do Roger, detail the proud be data and show would the to

Roger Dansey

Yeah. in No, he's very that. finding the firstly, said, that do Hodgkin on able an almost Clay is ADCETRIS, positive signal overall historically lymphoma as There's to unprecedented. survival little been

profile understand active Clay that in in Clay LV, schedule. super dosing us again, to regard. trial, order we're KEYTRUDA. agent, and data. on But presented I'll in to be needs data said. a it's as we by both an with So the monotherapy We trigger a continue for regards excited pivotal work to as is said, With competitive to what again, space. This we reiterate And that and what a combination

All you test see the either further. from to we we're forward we profile So can haven't bring disclosed or the to profile, can the right if still working create tell clinical that at the I any combination more monotherapy is information. and hard

Reni Benjamin

And Clay, I the and answer on fine. guess Got it. ASCO just your bit, is just

you In to I the have abstracts. guys XX of terms guess, sleeper, XX

that think feeling quite might So stage, excited overlook to it. on of make earlier kind you is might but there because about focus that sense really it's you're anything

Clay Siegall

things are in important there look to So at. many

on. tell just to one want I focus So you I know thing don't to that

stand that I -- to is, ADCETRIS think the comments me, the the most exciting. data critically by my I'll

Reni Benjamin

you. Thank Excellent.

Operator

will question with Fadia & next go The Needham from ahead. Company. Please come Ami

Unidentified Analyst

and the of Amin thinking potential My on of But you question. we growth guys. know is for you TIVDAK question do about This early market and Thank related for I is [ph] are how launch the TIVDAK the Thank behalf of see wanted Hello. if you taking to daily Ami. to the movements. guys ForEx?

Clay Siegall

as haven't Okay. guided growth as for Well, to really yet. TIVDAK the we far it

dynamics, the do So early far like comment not But as in to to would early we're yet. dynamics Chip, on the as going you TIVDAK? that

Chip Romp

Clay. Sure,

physicians So very are the have The alternative treatment are situations. launch is in new for to that patients, going really very excited quite a well. frankly, tough

we've we look the results really have continuing year. pleased current for XQ to the of So, throughout to we been the with and the brand grow forward remainder

Unidentified Analyst

you. Thank

Operator

The Zhiqiang ahead. go Please Berenberg. next Shu come question will from with

Zhiqiang Shu

I you two questions very for Thank question. much have taking PADCEV. on

to sales QX the think I trials? sales optical could know line supplying on to from be? side, influence assets? there trials. And you expect on for On in you more the you the combination see XX-plus How clinical from front X-arm the you seeing randomized that do another why trial. million the how reason question the the cohort have think the do said expect The that second can see in of if asked PADCEV. XX% full arm, model – was you What then see or enough we're And there's $X more the do you there guess the – the see pay already. expansion I ORR in randomized in [indiscernible] to combination question can do replicate year side. is, you We coming XXXX, is

Clay Siegall

all can Todd, data And can't on looking all, out question. Cohort and the you're trust will Roger, – clinical then address supply trial our with of That data. you're obviously. first provide clinical the that question going come to K, we maybe, So for, you

the tell line But is supply? give you can't So, the and and everything. you Roger can you what about and talk general Todd, required specifics give trial comment. a you is clinical we could what

Todd Simpson

to. happy Yes, Sure.

was there clinical those million to we've We As earlier, happen. $X QX. said when in call try a out supply order they

back was build typically third go try quarter was order. it not you think, about I a last I that $X guidance. if to think maybe that's a, guidance, respect we question few there something into With think our your year, to a million of about I quarters,

this guidance comment $X in already I because when gave our we Although earlier included did that that was our shipped. million it guidance

those. do someone we So, that's more we we something don't might orders? Potentially. Even would But come while it, include, them if said, will not there typically in. be see would we wait -- actually potentially control to

Roger Dansey

population. response And we or then have have in relation previously generated platinum monotherapy. to XX% date population, exposure data right, Co-K treated we to in in of agents to And the range, any rates not a XX% add PD-X in range XX% in you PD-X to are with including PADCEV, an inhibitors, sort and untreated

is looks mean purpose can't combination, will on of by monotherapy but contribution speculate understand all does I is I that primary The it, and what need the for So -- the just important. generate also which look I in to yes, We number randomized, like. like data that is itself. stand for the to again, monotherapy the would then it PADCEV understand space. reiterate components we'll what that

And monotherapy itself so PADCEV we the evaluate in have and to next again, the of chance to combination.

Zhiqiang Shu

helpful. Very

Operator

The next Sandler. Joe Piper Please ahead. question Catanzaro will from come with go

Joe Catanzaro

squeezing Hi, Maybe for one me for guys. Thanks in. much so one quick me.

Chip, in whether line around Thanks. steady know patients third of any achieved of new might adoption you I state early, achieved when setting into and that normal just XXXX? line still So patient is be into that moving have if delay assumptions is something the of third new the the it's about wondering with I but you flow spoke think, the inherent. therapy

Clay Siegall

ahead. go Chip,

Chip Romp

Yes. Clay. Thanks, Yes.

forecast question. good a it's to So difficult kind It's actually that. of

And on get what got the to approval the they've potential looks that see like to First, label. got of then kind impact. assess to we've market

I second-line duration is think delays new regimen a the note longer it patient introduces regimen in a can line, in important changes line that to changes of to if -- starts in that response. especially the third second cause

Joe Catanzaro

Okay. Thanks.

Operator

the I session. go any for Pinkston Ms. like to question-and-answer would remarks. back ma'am. Please our closing conference ahead, to Peggy concludes turn This over

Peggy Pinkston

and so I questions great everyone's you Have today. operator. Thank comments appreciate much, Okay. a evening.

Operator

for The conference now you presentation. Thank concluded. has today's attending

You may disconnect. now

Seagen (SGEN) 28 Apr 222022 Q1 Earnings call transcript