SGEN - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for your patience and holding, and welcome to the Seattle Genetics Fourth Quarter and Full Year 2019 Financial Results Conference Call. Today's call is being recorded.

It is now my pleasure to turn the call over to Ms. Peggy Pinkston, Vice President, Investor Relations. Ma'am, please begin.

Peggy Pinkston

good and operator you, afternoon everyone. Thank to fourth quarter like welcome conference all Genetics Seattle to you and of call. I'd full XXXX year Officer; and Roger are and Chief Medical Officer; With Siegall, Dansey, Simpson, Robin Executive Todd Officer; today Commercial Taylor, Financial me Chief Officer Chief Clay Chief President

available Events today's page. and Accompanying are call in website supporting are our conference Presentations the which slides, on Investors section,

questions questions. today. to during prepared our remarks, two ensure Following one ask yourself you limit our the able for we'll we're that We line everybody to to to that to open get call

This statements XXXX regulatory clinical milestones, including events financial anticipated and will timing costs, conference company's product and and regulatory approvals. anticipated and call potential revenues, sales, include regarding future submissions, achieve readouts, outlook, the data and forward-looking results, including expenses or to

sales, or results such difficulty from difference or process. implied developments these those the pharmaceutical cause development projected forecasting materially and may Factors the and a may in Actual associated regulatory uncertainty that revenues include approval expenses with statements. and forward-looking differ in

including the by and December the in the XXst, company's faced caption with and reports uncertainties Risk is ended company's the the on Genetics report Form information about XX-K filed under More Factors contained Commission, risks included Exchange annual year Seattle periodic the Securities for XXXX.

Now, I'll turn the Clay. to call over

Clay Siegall

commercial we metastatic entered our Genetics for Thanks, December, new decade with a of Peg expanded a Seattle as oncology and has afternoon cancer. In good multi-product company. FDA urothelial everyone. PADCEV portfolio approval

treatment used more and ADCETRIS patients globally important as on than horizon worldwide. XXXX approval XX,XXX potential breast of that in a lymphoma third brand is metastatic drug an cancer the the for has been Tucatinib remains in

-- we Genetics. progress potential is year people of Behind our more and banner help a believe with has than more robust that future of positively pipeline these the Seattle XXXX cancer. a potential three was to have programs novel products impacted

diverse December, both in more PDUFA sales ADCETRIS is PADCEV in settings. if will with ahead our approved product its months and team a XXXX, three from revenues as Starting academic approved, our late we tucatinib roughly sales engaged oncologists and Growing be actively with was community the partner, Astellas in strong PADCEV date. of to have space.

by We're months this number number of by pleased the first positive very drug onto the of and sales. four to and important recorded reception accounts in the vials increasing

early marketplace. in until are launch guidance experience the of have not more we in and decided We the phase to give gain PADCEV sales

approval. broad for development our applications confirm called are trial In the and recent trial in clinical parallel activities, urothelial randomized our focus launch accelerated is global intended PADCEV with This cancer. EV-XXX. a program enrollment are Today, with PADCEV support completion X a in we of Phase investing we the of approval of to announcing

first-line disease, Importantly, we have trial X initiated in is which a key global metastatic to our Phase strategy. development

is each a under trial Merck, collaboration Genetics, significant between conducted Seattle and being party This providing funding. Astellas, with

and also trials, In we other Nectin-X potential tumors. solid there evaluating these expressing in in believe cancer registrational earlier-stage bladder addition to is PADCEV are

to significantly breast line HERX the data in portfolio. has pivotal become the with program the This in in client in our Next is metastatic trial advanced outstanding metastasis. including from third of is couple tucatinib, which on based past HERX-positive brain patients drug months, just commercial cancer,

San Medicine. the published of Journal featured the New and in trial the were in from in oral December Antonio Symposium Breast results simultaneously, Cancer an Full presentation at England

Oncology on kinase the therapy FDA's inhibitor. in positions Based HERXCLIMB, being as HERXCLIMB best-in-class completed which the of tucatinib under which potential supported program. HERX Review FDA is breakthrough submission December, tyrosine we Real-Time designation, results, NDA, the reviewed

for FDA-sponsored recent Switzerland, Australia. January concurrent program the submission Project Europe. in We're a review MAA in and was tucatinib EMA with accomplishment validation an also oncology Canada, framework States, drugs participating the among United regulatory the significant and submission Orbis, Singapore Another at that of of provides

these drug tucatinib the each We submitted in now of for countries, later global have positioning this approvals year. beginning

to the With expanding we're process mind, our in goal around in capabilities. European world. bring to the in need patients that Our is of tucatinib

the Through leadership prosecuting our key Switzerland and teams the we countries. in Netherlands, and submission States, we're MAA United our adding are in

these with to Roger development clinical will important we conducting additional the are making As global tucatinib. investment Tom provide on development with we PADCEV, and speak the a program broad activities are will details in programs.

This rate to and the by and growth in peripheral to pleased report ADCETRIS. $XXX lymphoma. driven revenues XX% adoption XXXX Canada We're US front-line follows XXXX. record now on T-cell in in XX% XXXX, Moving a lymphoma up over of million, Hodgkin

XXXX with to together in sales its territory, the sales and importance world. underscoring billion, exceeded global in its of Taken ADCETRIS physicians patients $X Takeda around by

We $XXX ADCETRIS to million and net the U.S. expect the in range million. to be XXXX in sales of $XXX Canada

brand. will the reflects of this for ongoing trials provide we ADCETRIS While more expansion that modest clinical additional growth, with believe and opportunities planned our

We survival front-line also report to ADCETRIS late an in could milestone AVD. plus lymphoma long-term lymphoma. is the for trial and patients establish from of benefit expect further ECHELON-X progression-free this positive important results year This five-year Hodgkin a

Genmab. tumors. stage clinical trials programs is with developing are or both Most vedotin TV, advance malignancies of is are and we hematologic Our a and pipeline conducting robust, tisotumab of across we collaboration spectrum in which solid these

initial metastatic cervical in recurrent focus cancer. Our or is

trial line top report to the data of from half expect a XXXX. potentially pivotal We in first Phase X

intend planned and agents. and our targeted form optimize XXXX clinical intended candidates, evaluating also solid in tumors, efficient trials based TV with These several other in other another four and including innovative to design XXXX. XXXX, decisions. on INDs investment rapid including to early-stage development underway activities schedule. programs dose and and cancer, continue initiated head that are clear are ADCs with four and are In we in ovarian novel and neck We trial We form therapies new product to with

the review FDA ongoing recent using and more namely ADC clinical XX partners. programs, of our U.S. validation us pleased than these ADCs mafodotin. by MAA also Both technology Genetics' development collaboration of proprietary and are technology. EU Polivy GSK, Seattle the with Roche's ADCs There and We're of collaborative in recent by priority of employees belantamab approval our the and progress

X fourth China, in company we milestones. of the collaboration with increasingly XXXX, payment a trial. important and entered market progress-dependent program an license an Phase of recently in first with completed anti-cancer we for This our agreement a upfront This $XX in quarter BeiGene, million Lastly, included are clinical eligible for therapies.

exceptional investing portfolio fuel across needs We're to and portfolio our revenue I'm meaningful growth. in addressing proud of our medical and our diversifying progress XXXX. unmet commercial drivers, future

positioned into focused company on world. the patients cancer Genetics important an well to We Seattle transforming biotechnology helping are continue around

I'll financial commercial At this After Robin turn and will point, Todd on will to our to the Roger that, discuss discuss Then guidance. clinical XXXX comment results our development call Robin? our over activities. activities.

Robin Taylor

activities. Hodgkin the XX% excited update Thanks, indications sales sales on our $XXX frontline were commercial PTCL. our and to XXXX. in compared were fourth same of and in ADCETRIS lymphoma in net quarter to increase the million, provide an $XXX driven by Canada increase XXXX. Growth U.S. over was in an the of Full-year million Clay. We're quarter, XX% an

who Claimed A complements plus ASH offers data adopt plus over follow-up A presented been enables patients. slow regimen. the clinical AVD meaningful from ECHELON-X value benefit have to at the Full-year that AVD ABVD, proposition with of the were that trial physicians ADCETRIS discussions

this data to We the also five-year look forward later year.

are promote now its on For under indications. ADCETRIS XXXX, we that focused broad includes continuing to label six

and lymphoma. stage clear in the III Hodgkin plus the describing A for patients You're of and durable IV with advantage ABD frontline setting

drive the use is expressing CHP we plus A for with with reporting labs standard PTCL, while to additional frontline in improve the patients CDXX and ALCL, In hard of working subtypes, CDXX. to engaging care of pathology are

we ADCETRIS franchise. growing intend With these continue efforts, the to

positive. PADCEV, accounts from Seattle to And from ordered have Genetics full exceeded to in transition our late Astellas month which I'd academic our field. has and community launch. approved forces is XXXX. the are the like number of physicians January, and sites PADCEV Reaction expectations active of first was that both Now, sales in in very

cancer were PADCEV. treat representatives X,XXX these there that already time we've patients estimate In X,XXX States that been of accounts. short market, order called may on the United and that the of the our We in in period metastatic accounts bladder have approximately

the of rapid NCCN unmet We're therapy. treatment platinum is understanding The throughout is team urothelial in on PADCEV option. cancer need progress and also new about our or with the year. updating significant in post treatment on pleased focused guidelines. forward awareness I to There metastatic inclusion you driving chemotherapy PD-LX the and look important this PD-X

Symposium team positive to reaction Moving presentation is Breast and HERXCLIMB on at Antonio San clinical tucatinib. in the the The commercial from December. excited data the to our Cancer by

experience. oncology with U.S. needs attracting with place Metastatic sales and especially Our options team patients, top We're sales positive awaits treatment team sales eagerly force. brain we the and talents approval. significant the leadership in hiring HERX our metastases, new is those are

Seattle commercial unmet at as year areas patients well-positioned growing in products we of for to meaningful the team Genetics a summary, need. In is bring transformative

turn will I to call over Now, Todd. the

Todd Simpson

for call end for financial fourth quarter I'll Great. summarize I'll the on afternoon. us the results outlook Robin. this thanks, Thanks, year financial our And for XXXX. full everyone, Today, our then provide joining XXXX. and And

of the year. fourth launched sales were million in for quarter at the $XXX year. provided the holiday and included fourth the only net quarter the and This in the sales. revenues for $XXX and full year, contribution million the end a of $XXX $XXX Total period to XXXX was of million ADCETRIS during million therefore, modest PADCEV

included of its $XX was million annual the in fourth $XXX triggered in This XXXX. $XX the million Takeda million ADCETRIS million revenues a sales quarter from of increased that XXXX quarter fourth milestone XXXX. of one-time $XX Royalty exceeding in to to in territory compared by

a year increasing higher year revenues above to from $XXX mid the rate $XXX Royalties and contributed by results. sales also milestone, in Roche Takeda sales on on million, in compared royalty growth sales were to million, This For XXXX $XX XXXX, full Polivy ago. the XXXX reflects a XX%. royalty to million

revenues million $XX Polivy to were ADC lymphoma, million $XXX year. in in our from of trial Hodgkin milestones of million Phase FDA revenues $XX related $XXXX with fourth full technology. the and Takeda GSK's quarter included the X Roche's in ADCETRIS utilizing frontline approvals initiation and approval These our Collaboration the for of international of

fourth expenses million quarter in the a in into BeiGene licensing we upfront the $XXX recognized $XX million upon entering and payments from million R&D product of Additionally, $XXX fourth XXXX in for quarter. the were led approval the PADCEV late-stage pivotal XXXX that tucatinib, notably investment tucatinib to the Growth included across submissions. year. pipeline, from reflected PADCEV most and which and trials over our the agreement higher

expenses fourth $XXX tucatinib. preparations and indications $XXXX efforts for quarter over increases year. million and for related and PADCEV reflect both were ADCETRIS launches and $XXX the XXXX of the front-line are in commercialization full SG&A These the million the to of

We ended XXXX with and million in cash $XXX investments.

million in gain income shares are led $XXX approximately in to this that million to resulted held contributed which Immunomedics common a in press we you non-cash net and fourth that $XX stock. for addition, the In afternoon. reporting saw income These as mark-to-market, investment us release quarter our of

outlook financial main XXXX, guidance. for There are our begin components. Regarding with three I'll revenue

in and First, be $XXX U.S. sales Canada million $XXX range we guidance. million. the the At not of time, PADCEV expect to providing to ADCETRIS we're net in this

Second, we we agreements expect million from million anticipated and million. Takeda. million, range the $XX to $XXX based in third, to growth $XX by of expect of revenues And royalty to range sales license to primarily on the of be ADCETRIS be $XXX revenues collaboration in

expenses. Turning now to

our in This primarily across the portfolio. million. expenses of Similarly, of SG&A team registrational to cost our full-year PADCEV and reflects be and commercial tucatinib, well This to expanding earlier-stage PADCEV We tucatinib million. European expected range commercial including as as in the to to a increase investment to R&D range $XXX expect $XXX capabilities. million $XXX expenses building investments several $XXX planned includes are infrastructure, trials, our million of

of cost sales sales. X% in ADCETRIS be of of X% expect to range the We to

R&D also Marketing profit As Seattle we development in guidance. cost netted of Genetics are the been These and booked U.S. a expenses of a XX% PADCEV will share out equally. shared in in our expenses and sales and of SG&A reflected have record sales. Astellas' and our are as reminder, gross of component

have up, an the in plans wrap potential of we bold and to drugs to our to significantly So opportunity help expand XXXX patients.

over call specifics. to provide And of some the I'll the with will turn who Roger, that,

Roger Dansey

Thanks, Todd, afternoon, everyone. and good

as Today, As of we cancer. mostly our an plans exciting on PADCEV for exceptional important development tucatinib in medicines Clay drugs. remarks bringing year achieving for Genetics focus described, XXXX Seattle of new each will my ambitious goal these for I was have and

main begin components cancer. priority and I'll with product three first is continuum this to PADCEV across strategy. our evaluating are our of There the urothelial

a regimen program, EV-XXX the inhibitor. trial a conducting cancer and called Phase in approval platinum containing trial the required randomized urothelial received metastatic under are First, the accelerated confirmatory or PD-X Astellas FDA's is PD-LX patients who've and X we and global

enrollment endpoint trial, Today, of is global to patients. applications for of the overall we approval. addition support announced in its Primary has XXX and completed it study of a survival intended firming EV-XXX, confirmatory to

Second, first-line our into PADCEV metastatic next goal urothelial is to move cancer.

encouraging Nectin-X at Astellas is Phase data of ASCO first-line which initiated PDL-X importantly, or the and evaluating X and week patients will trial includes Merck, and on next platinum from expression together recently PADCEV Target be of or with combination a updated Based combination patients chemotherapy. eligibility, with regardless GU, we this enrollment without approximately expression. X,XXX KEYTRUDA,

muscle earlier with was stages and invasive third, risk trial cancer. overall of of the survival. high of goal metastatic occurrence including progression-free These surgical to And cancer, start in evaluate patients bladder urothelial is bladder, The removal will a endpoints, beginning the there PADCEV of treatment disease. dual our evaluate survival primary

both We combination clinical surgery. are medical these development therapies for invasive evaluating difficult evaluation currently the to tolerate a and and bladder represents recently opportunity in resulting PADCEV KEYTRUDA monotherapy initiated may significant prior that Non-muscle are In future a pre-clinically. available patients, need. also unmet we of and of fail, PADCEV PADCEV cancer to

cancer cancer, called initiated believe to EV-XXX types. cancers. tumors, head for and lung, Nectin-X extends other gastric including seeking the expressing of cell a and and solid range Beyond recently we Astellas urothelial non-small a neck in PADCEV breast, potential signal trial We

trial. oral to that by were the now at San kinase enthusiastic gratified Antonio targets tucatinib, in remarkable inhibitor HERXCLIMB Symposium results from Breast our tyrosine pivotal reception on Cancer We the move HERX. I'll to the December a

X include: upon us program HERXCLIMB metastatic a HERX-positive expand combination clinical in focus conviction our in tucatinib cancers. versus randomized first, of with breast development breast clinical areas other in evaluating data TDM-X cancer. trial key Phase give The cancer HERX-positive in TDM-X to alone and

called trial, a setting trastuzumab population represent HERXCLIMB and must In first have metastatic second-line or in taxane this or treatments. received thus, a patients the adjuvant previously receiving X, and or

tucatinib, Second, in trial. the X combination evaluated being neoadjuvant cancer standard with treatment through I-SPY in breast is

breast in HER-X-positive cancer. In a addition, considering are trial we adjuvant

the trial XXX to Third, third-line expanded enroll After combination the and very initial data XX MOUNTAINEER from were with we to in have with disease. the trastuzumab patients existing encouraging. FDA, of cancer colorectal consultation treated metastatic clinical called metastatic with tucatinib up the patients

a this accelerated potential is approval. trial Importantly, to support intended

cancer. are also trials on confirmatory the plans colorectal And We solid working for trials including HERX-positive in in cancer. planning gastric lastly, we tumors, are

Next, ADCETRIS in presented subject many meaningful note, Annual in Of and over I'll which the were show turn the to data progression-free ADCETRIS, to Hodgkin from presentations ECHELON-X full-year the frontline clinically survival of at benefit ABVD. lymphoma Meeting in the trial plus sustained important ABD December. continued was ASH

Hodgkin time, elderly effects lymphoma for improve and both These lymphoma Peripheral most neuropathy ADCETRIS over revised lymphoma, guidelines relapsed Very of frontline recently, with T-cell to lymphoma of positive the CTCL. were ADCETRIS, with are updates. experiencing number side known continued included patients Hodgkin a Hodgkin and complete resolution. with NCCN treatment cutaneous

patients Our used ongoing includes clinical unfit large and frontline relapsed/refractory combinations combination are B-cell development ADCETRIS planned lymphoma re-treatments, lymphoma. who chemotherapy, with program novel and for Hodgkin in diffuse

Clay. Now, I'll back to turn call the

Clay Siegall

Thanks, Roger.

our Astellas continue open in cancer. the key broad including include, we trial program, to and first-line across recap States oncology your I activities urothelial United our the strong first, a portfolio. They questions, a in Before Phase launch upcoming line development metastatic for want X with PADCEV advancing

robust tucatinib regulatory approval other and agencies advance program. FDA its clinical development with and work on Second,

front-line report and line and top ADCETRIS trials. the of in cervical PTCL, front-line TV as results first cancer the initiate in of Third, trial pivotal care fourth, clinical establish lymphoma continue And from Hodgkin additional half this in standard to year.

of As on we our future Genetics. are vision highlighted today, executing bold we've the for Seattle

At the this questions. Q&A. the open call we'll line please open point, Operator, for for

Operator

Bank Yes, Meacham our of sir. with America. first And [Operator question comes Geoff from Instructions]

Geoff Meacham

got just I question. the couple. for much so Thanks a

at been is So, and first you wanted and about ask for trend lessons the just a at be the into seems duration it than are when you learned to high your world one when commercially guidance. PTCL ADCETRIS the commercial expectations just HERX XXXX? what's any in then feel or look on so can I TYKERB other to looking on the tucatinib, like And leveraged tucatinib real PFS? guys. different is maybe there level, be for And the to Thanks, the others therapies from that going launch? talk

Clay Siegall

question ADCETRIS with guidance our trends that. and start and we'll the So, stuff and like

really is So This the internationally. first first off sales. over growth, U.S. sales two this XXXX to guidance to And we XXXX in doubled and that billion XX% in X% we the grow of in growth U.S. to years. sales ADCETRIS. XX% had hit of reflects ADCETRIS when of $X double over step the put the year all, that context. – we've was – the into And XXXX. last last global brand I'd and a XX% years, continues two comes like that and back in years,

Hodgkin, front-line PFS the in data. five-year Hodgkin presented later standard, that and December in expect the the ASH data four-year Conference at gold five-year this front-line. we lymphoma In data a year, That's we have we and

should docs. helpful So, with be should that –

use, doing think have essentially mentioned growing, of to That's exercise decades simplest job the I we'll and not and opportunities been we've that. it care to that. it continue a still and entrenched is non-ALCL good. But you displace do to are a data that continue standard PTCL, increase, In we in to old great as to look

Importantly, thinking future, about looking the to guidance. with ADCETRIS,

trials. these with expanding trials continuing are clinical opportunities We to do and our

are opportunities of these of are some Some incremental, them big. but

elderly is one two early-stage there looking in and DLBCL, at retreatment Hodgkin we're and things Hodgkin So, lymphoma. lymphoma,

I opportunities lymphoma, and bigger doing some of that things of some lymphoma early-stage lot smaller. like frontline a different not, in like and are its half said, where we're we So, Hodgkin Hodgkin are

it's for terrific and product future, tucatinib. expanding the into Seattle Genetics. to And we're our looking to product excited is ADCETRIS Overall, be Geoff, PADCEV, first include really a – so

of can about lessons safety. at we we how taken We're asked stay you efficacy a that. and twice by a It's very you on will and profile long guidance giving got on a Now, point and patients saying this I this. not that's learn tucatinib not what duration It's tablet that. good think we're mean, day. –

can really used what are want bit, this data little we are development the parameters you I bit or with – what of duration Our different how a this Roger, little but settings. And have in perhaps initially, product as just remarkable. it we'll be a think learn And program. to look Rob use about you you think we see talk at

Roger Dansey

Clay. Thanks,

also the in can suppress then of key of tolerability tolerability. periods tucatinib population, is and of of efficacy, access. time. continue into to for be HER-X putting molecule One the the breast patients studied key high is has its metastase It a the cancer. obviously very the is And But with its unique we in aspects plays protected stay brain tolerability efficacy actually to signaling believe patients on that drug frankly,

We have the on who been have the years. for anecdotally, program patients in drug

extend in therapy X So, Based duration comfortable about that, I trial the duration itself. think we around quite the months. progression-free is on is average are survival, treatment clinical achievable of that of

used dictated therapy areas periods other by we into maybe of tucatinib can of disease comfortable for state, the But are where duration obviously prolonged time. be as that we the move

Operator

right. you. Thank All

Our Richter Sachs. Salveen next with will question come Goldman from

Salveen Richter

for taking afternoon. question. Thanks Good my

some why year? the for just regard guide, approximately just this is metrics feedback XX% can with can And us XX% you XXXX anything you conservatism at over play at accounting you're or you regarding launch as such saw to growth your comment at Padcev? limited ADCETRIS early launching then the growth here? dynamics qualitative or just and last And midpoint, are give given there this on secondly, you looking So

Clay Siegall

that this give to in about could portray this. as we commentary the do, Todd conservative doing guidance some our us here and hop want anything. but I want not not and ADCETRIS On providing or anything, don't maybe to best you

that brand U.S. growing I first brand have we approved got growing think and that in XXXX and this been and and growing both in international. is the a

It of and have has slowed of is the are been for around in. slowed The rate And new brands we're by -- lot has really excited investing And brand have this still still growth lot growing, down. X of years, but we we is new a findings down. data, that a unlike and growth the but that.

comment Todd on some could has and will talk could we'll And And wants the see additions Maybe some this. talk start recent Roger, so he very Todd NCCN. there. about if on to you put NCCN Roger perhaps it. color he to about

Roger Dansey

Sure.

the domain interesting. And It's reflect NCCN is not continue actually, public necessarily is amazing patients that is valuable to so The out may Guidelines registrational a -- that is for it be that that data trial. put in

together from Opdivo of the the in content example raised circumstance, on evidence my good use complete which with of the that where A has ADCETRIS that. been basically value is of Hodgkin level XB a to mean of lymphoma XA, relapsed/refractory

take disease, in to features therapies older stage addition, way also lymphoma using that is it older it novel actually as but it ADCETRIS populations patients, with with population. has reference to stage followed of in that X, such chemotherapy, includes not use product which made by ADCETRIS, with sequentially struggle to AVD, the In to another represents – that X unfavorable guidelines older just earlier a Hodgkin patients and to combination

we the directly CTCL, the lymphoma. usage have know, for respond. referenced the is cutaneous ALCANZA was below a level do primary which not who ALCANZA know in done cut patients now there that XX%, then trial, the acknowledgment, with And still well and an that point trial reflects XX%, expressions T-cell state the is we guidelines the of that interestingly And

is trial. guidelines the population broader So [indiscernible] probably that have acknowledged

Clay Siegall

NCCN guideline this additions week. those And were

is brand new. this So,

But new color? or was additions, for I ADCETRIS. so before and guideline think any yesterday brand it Todd day additions three the the additional to

Todd Simpson

It patients that comment important helps Yeah. of drug. Salveen, lot is globally. a big a ADCETRIS I I'd guess, just

U.S. over Canada, globally. We're Clay proud in of billion and sales. the mentioned, now the very We've, doubled we're that. we As $X

last XX% XXXX. and XXXX that Over the years was had we growth in two XX% in

growth been a continuing future. been the catch and after there maybe of a to there here mentioned But little a what's give pretty we that us we're think lot in Roger remarkable of So, trials is in XXXX, breath invest of can has growth that run. bit a

I our in We've think ADCETRIS us off approved. can looking help we're what an provides PADCEV incredible and really to to enviable base given strength build approval we globally. of. really got position very in into PADCEV now tucatinib important for have a drugs in where, tucatinib We're invest front we and big of us, meaningful drive patients to aggressively trying that and

is ADCETRIS story. an think that base I important So, to

Clay Siegall

your to going And uptake going on there. and on question Todd. early what's PADCEV Thanks, second

So, that but guidance what and we possible want soon conviction. guidance it. way, and we're were yet. provide approve opportunity, not organizing to have we as In I as the – But say just of to towards we that and we'll and patients. of provided to But we year to meaningful just provide the you that not their docs we to want I we first all, really first want give – have a end going to financial want were we

it's sales. now really full only first the was had February. so in month where And So January, we

conviction PADCEV internal and said having with exceeded we but our which of far not – so with And We predictions, kind made the are some uptake. incredibly pleased are predictions. internal that,

X,XXX happy in with Robin And predict the about X,XXX U.S. we've that is vast called accounts, upon. been majority the accounts can it. of said, sales. there Like have of out far, we So that, the about be of really

the the X,XXX. about those focused X,XXX ones that we the really of full five the we X,XXX turn force, out the those. we've seen at weeks, there it are plan. And time really caller… full have, of this But We'll drug important in have out we're over development this that same those to next we So, on, are first in talking

Peggy Pinkston

question. Next

Operator

Yes, sir.

Markets. Kennen come Capital with RBC question next Our will MacKay from

Kennen MacKay

and ADCETRIS conversations, been to the is areas down for for revenue from prescribers happening wondering volume the Thanks from ADCETRIS I help the was And you what of ADCETRIS on slightly needs the the have front-line Hodgkin's? any seen of questions. teams' us over Can data Hi. QX? some gross-to-net or win in quarter-over-quarter. there in impact reluctant, on the five-year basis understand growth, was the to just doctors taking inventory who ECHELON-X in a maybe what's whether be

And elaborate on then, a potentially registrational you pursue wondering DLBCL. follow-up. away I in decision was from invitation secondly, bit you. ADCETRIS after And Thank had on walking could years if then the I little quick a that there ago. several to trial

Clay Siegall

Right.

the lot to revenue really do As We've far gross to comment? as all and and make net discussed that, a Todd, quick a want you this already.

Todd Simpson

answer that, book I your stable. fairly was of variability. net of gross to fairly The would to too but guess was in say, different get wouldn't into quarterly I stable. I hung business specifically There up Look, question, get are numbers sales days. don't I to want

year-end, into bit Coming stocking. you little of a see

ago. was it think a saw we probably I to comparable year what

think that created I don't So, variability. any significant

for look pretty the we at up year. had numbers this think, So, and I – good some we put year-over-year there

Peggy Pinkston

And the I a five-year problematic that no mean important? what's important actor. ADCETRIS and your what's drug That question a is is, obviously, tell efficacy bleomycin. for patients. lot this will data safety is was safety. has and And what I away, bad about is of second front But you right on a

agreed, up taking to, morbidity thing. bleomycin, have so some is change all in is good come their that also they lung literally something permanent a not by And see Patients that's and problems we've with have life. late bleomycin You scarring talked taking permanent it. every doctor

what presenting we And are is PFS.

come PFS and out first of FDA when a not we ago agreement on with called at and had was why data our from had lot people all and recall while we modified may an You PFS PFS that E-X, got we modified with regular something it looking hassle a that.

then So, the PFS. everyone that's five-year data regular using regular just with full PFS started our the starting, we be regular and with year or it's -- modified regular we I is will the what And asked PFS three-year, strong, because PFS, for. think whether

is So us, how say are with what no to standard. well, one these hey, will Because we're different, difference? using the the

the And X%, X%, to a And oncologists, and it's equate cure. they something. X% die the if the a cure. going But that saying with of you all at In long-term defined in look to years, we survival. you five-year be progression-free Obviously, up difference survival see that. we're could five start

what four, So rate X%, the the comparison bleomycin. increase to whatever, by win. same That's cure no defined years a data if is year five the X%, that is at you we have, can X%, that there at see in time, we

look And at. we so that's what

Now, you at, ADCETRIS. and to what we're about do in and we're looking that we looking Roger, asked perhaps trial. efficient talk you the what want want for DLBCL study to about And

Roger Dansey

Well, thanks, Clay.

that the CDXX. DLBCL thing. relapsed And factor, appropriate general, patients. the is meaningful of the has to cetera. know we DLBCL So, DLBCL that ADCETRIS we demonstrating number a have an et in evaluate, express That's data first place in

of can also with actually we respond. a level that, load expression, Beyond lower patients

and its ADCETRIS the group for of CAR-T in on. its patients an we and a for But efficacy planning around have all-comer therapy, the expression. CDXX things treatments profile great are option sure account based we safety on so like are and will who and be trial failed So, to profile is we space of think a

don't so wasn't of think was rates. made an acknowledging ADCETRIS in any so was that I the this us way prosecuted, is this value fact taking diminishes attempt that -- earlier And

excited. actually are We

be need we ADCETRIS that is supports DLBCL. relapsed the patients very get to to strong. are help able but I think the with conduct think that trial the we obviously We optimistic, may appropriately I trial, to data

Clay Siegall

let's make it analysts quick follow-up. want lot because a to talk. had short there's a Kennen, a And of who one other you

Kennen MacKay

lastly, color. the on steps could was appreciate next comment if what with Sankyo. wondering in resolution I And No, Daiichi dispute just the you ongoing are

work stated resolution. with much within your Our is that very stance

wondering just So, next steps.

Clay Siegall

was report interesting. did were saw certainly we that. very Kennen, on working not So you know We and your it

a to So very have your case. our will similar it see is that. be us to that conclusion for we And interesting very, conclusion good

would And that. and sit that soon, We the it them process. patient go should court. in agreement they rather that an steps believe But court toward issues will take and and arbitration would whether with stated on What report. on on XXXX I our rule that have it's to to you is we're publicly there a time legal say making they -- be through based the

But strong that, this case for hard other inside XX it's a for years. history you have to except in very give me than that. We guidance we Seattle Genetics believe of on the

like We and have a legal this. never done gone move out proactively

will company We the a day the the are something the IP do if our obvious. but This protecting have to first and of to. to us, we every something obvious when done that's time of pretty is we need week company, IP is this we it, we protect not litigious is see we've but

Operator

sir. you, Thank

Andrew will with next Berens come from Our SVB question Leerink.

Andrew Berens

Thanks for taking on not going to Hey, guys. ask one the questions. I'm ADCETRIS.

pushback any then PADCEV? But there Has on think are you questions some already, us have a I tucatinib. give of question chose? do for that there idea point on And you obviously. payer how been price going I were lot of the the discussions can

Clay Siegall

I tell that turn in just to pushback this Sure. at Robin. been very think good -- a I'll it's job comment -- we've We drug. a you, great. doing pricing really all. this will on we we give had did over I haven't and

a that put you we below the brings, this add very that oncology If of were drugs commentary? is lot this But want there value of it. drugs that, and you for priced any Robin, drug good number to the a very look PADCEV there think at a we've do high quite of are world in above prices, spot. price

Robin Taylor

Yes, absolutely.

PADCEV. issues, monitoring see, There is So, is really no we've are pushback this. we're arising seeing. what issues there to And that with no been that if seen any are we've

have We patient solutions PADCEV in place.

So if out been with that. the is and we that going across, launch that there an are reception challenges very the account comes help them reality have But very ways physicians. positive a from well has to then

a need high it's very So unmet population.

Andrew Berens

is the can to when expanded you tucatinib, the accelerated we out, now what And expect And approval? Thanks. think it? read for you've that Mountaineer on Okay. bar an then do

Clay Siegall

asking Thank Mountaineer. the for on you question

very in have review of we Roger agreement is interest And is would And and his unexpected regulators somewhat and would data about went audience. a team that an So, there the put out a that strong was we and say, talked it And obviously, expand decision at lot to Mountaineer. with it everything by take But this. ESMO. and we regulators. trial that I were

pretty would But to but approval as potential super regulators for registration, take a an to existing XXX incredible to patients trial out trial jazzed and trial, confirmatory and not granted, restart we're that's it, just need that. about expanded bring we back and a it

adding it and And and trial. open so cranking just that's onto a was

I we're and And and taking We're running, We've seen. data that things haven't a and different trial carcinoma. is hoping think colorectal we something great see for that's that looking better. have and great HERX-positive This where them chance. wishing we isn't combining it we we're something not data, seen corporate a really in

cell on of and trastuzumab We hitting outside the have the of inside with cell of combination the and the the tucatinib.

really is mean, is really this the think that outside want that? and I on to double something that. add Roger, so hit I'm went inside to do a this And I we looks about great sorry, you great. on opportunity.

Roger Dansey

think, do I I now would Genetics timing. we to Seattle a obviously can't what trial. you, is about talk this say But one,

the and we as of behind its the So the full fast appropriate go company and them. we them But then resources time. and enroll are the can, at effort read will trial as

Andrew Berens

obviously we And since it's sort controlled drugs, quick other of has of or Herceptin, indication, Okay. other required some follow-up. and which top combination. One FDA just on guess guess, comparison. I I sometimes

this be So, I guess, trial? on willing efficacy single-arm approve to think enough what that you a is they'd do

Clay Siegall

draw of don't showed us – sand have more like on Herceptin but rate XX% with have tucatinib. using mean, we response you lines they write trial, would alone. And our XX% that's so something have And I we think been. in the we with above response monotherapy and the multiples we like we're and rate, do combination. in what down published Herceptin Andy, a – in So, reports numbers,

know some do we So, of the components.

So, presented with Herceptin. a lot of work is done, and been have

We regulators us. what have need. they've I and feels have And to we of the colorectal, that's like tucatinib combination, the they have monotherapy it indicated what and think,

approval, we at data can expand you promises, the them we'll have make get ongoing pretty is go to can't your but this and we say, look data until to trial. and obviously, special. regulators So, And

of good we go the doesn't have match. data same. have It's It pretty think I just obviously, and it us even can't It Just exactly room – bring don't there. as think we've away. good. we as darn But more can't I to need don't even had.

Next question.

Operator

from Stanley. with Matthew Morgan Our next comes question Harrison

Matthew Harrison

think great. bar TV question. taking about get one for I no we level you this you study year? Thanks. that yet. Hey, confidence your Maybe wanted the in Thanks up just about, the when could around has to and what ask is the since talk that brought that just data

Clay Siegall

escalation for Phase TV binds factor on an this part partner and this you presented TV. about it very but are working in dose of we a X. of with we asking that is ours antibody-drug We Thank was It past, to the tissue on with. worked a interesting in conjugate. closely data Genmab,

data. know all hard of So it this to is on very and factors the

bigger are partners, So, Phase we our now doing trial X trial, with Genmab, one dose. a a with

expansion large Phase is a potentially registrable. into X. is It it So

of we're about that for important excited and trials we're with other have and us. working TV. on this an combination trials variety obviously, a trial that is things We, But

approved a say, was was in. with percent PD-X the high or of context potentially about I KEYTRUDA. a that response by we based XX, see that putting And on we to and think duration registrational from relapsed the the I in had to was think meaningful. could and approved PD-LX year I high, They X-X a that that screen for start and that, last X, drug Phase rate cervical need was That into was this something cancer patients. should that's

the so population. even patient all And wasn't it

at too For not showed for about something all we that approved. substantively We'll rate we give could XX% also dreaded is little as get looking big that early talking but and which we're excited for not patients patient rate something if lymphoma, of cervical of If hope last registrable a But data, you showed talking there very we about you response about. our population the and to higher just where our condition. cancer, the potentially relapsed, trial drug response are we're and this for is duration. a not people have that's than from opportunity watch X, have was us, Phase in drug

something if possible, get a us as not something as that I I and four, that, response I or know, good five, could I don't with has of something add. would this or a see four we'd we to given rate we six, could think five think months have than the in and substantively I get we long. say love more very with line duration in months something duration we FDA more shot. XXXXs, a But if really think we much the more, But want have

a as other have agent. want this from will to combination cancer, help probably with alternative Yes, to going to to for I another with tell you really okay. the have to patients okay. a no that's I study to be to relapsed that's in on Now want come the patients step able future. alternatives. single Yes, we who we cervical market me, want one, that me And get

and XX%, to options. chemotherapy me, we get whatever that it's have then approved if whether or XX%, I/O response to it I'm therapy or looking this potentially XX% no But what in we do. combine could and rate could literally up with we can to get That's patients

excited into even patients. a if these approved. get better we're try by this to we do to excited We're drug So, get also this see could and to

Operator

sir. you, Thank

Kasimov from will Our next JPMorgan. Cory with question come

Cory Kasimov

afternoon, guys. Thanks the Good questions. for Hey. taking

you. for have Just ones two quick

next might follow or your all, first saw In at So of, we week longer GU it more how for this up? terms update regarding just ASCO is patients differ what from PADCEV, of just ASMO?

reflects have, yet? plan for out question I is that second or reads XXXX out the that then any guide assuming positive And curious if build there just in TV, not the trial

Clay Siegall

Todd So the and I'll moment. in XXXX and start over turn PADCEV. guide it the spend GU with to a TV and ASCO manufacturing, I'll

at mature this ESMO presented perhaps trial to guidance? present trial at we did the when We are disappoint incredibly it the have lot say. was of Todd, was would trial. don't and ESMO, one was we ESMO. weren't were the data time, and -- think -- ASCO say, of that's But going not anybody. stars we it well but going everything update we I We received. GU, interim a a At star data. of update of the we're I to the But to the

Todd Simpson

So on to -- your with guidance. the then TV respect question guidance and

Clay Siegall

and Manufacturing stuff.

Todd Simpson

in still data that into that's commercial a on. then our support hit and yet bar in we're to built see the we that articulated question, We last to put Clay if that dosing work out. the but hear backed get some we're clinical that to just There that a will I build us want And build. can is haven't that doing, we position the that looks. Yeah, thoughts trials start how our in on how mean, working we to

Cory Kasimov

you, Thank Okay. guys.

Clay Siegall

hope spend to really quickly I -- issue we have that we that need manufacturing. tucatinib TV on

Okay.

Operator

you. Thank

Schmidt with Securities. Guggenheim Michael from comes question next Our

Michael Schmidt

two One had on guys. Hey, my Thanks TV. follow-up I taking for questions. questions. pipeline

cervical the work understanding if little done there I market bit us You've you opportunity year last cancer. some just already, but with in a initial wondering help can was

year be had a a treatment how this year? And candidate per many patients should follow-up. then I succeed example, TV-XXX might For

Clay Siegall

for. about with But XX,XXX this Well, but everyone called even we're is that a just not other in what -- which where look in giving were a U.S., you places. cervical specificity diagnosed not when Japan lot in includes This guidance it. around some countries, a it's in And everyone Brazil not only having that and cancer. is we're vaccine, but And other fact, now of it formulary. in not and getting asking you phenomenal in tell gets fact, is point that is the I And globe, not there GARDASIL, United not it. the the the patients in are States were at is the will you with despite a vaccine countries,

reality. it be globe And everyone So we business is no many and GARDASIL. last a the when not and taking pack diagnosed have travesty. TV XXX,XXX. with you the that's and very around start happy looking it how patients if would That was cervical to with up cervical cancer, at But cancer were home, was year go

is said, globe wiped is if not And you're want it reality in a a love disease really the something about horrible sentence. we'd this devastating is. just if death to with do like I had everyone disease. vaccine was this it. we that where it's And But The it's the it, out. But diagnosed and --

with was when people in tell the not cervical only you, U.S. So, cancer. I X,XXX there U.S. XX,XXX died over patients over annually but in diagnosed,

I So each that of get can of give you patients launched data some and year think we as dying to be give get we this, diagnosed that more are can going along, we we assessments. number idea the if address. that we're further Clearly, more will as detailed

Michael Schmidt

been approved wondering setting. I for was how how those was what stage a bladder some then for news I affect opportunity might maintenance the we've PADCEV from results and opportunity. recently earlier front-line metastatic has Thanks. in guess, regarding our market And and seen PADCEV Roger just the some then is your view the and BAVENCIO maybe And patients -- of Great. things there one on cancer study longer in term? some KEYTRUDA potentially

Clay Siegall

Thanks Michael. question, for the

So using the avelumab great. readout a one approach, maintenance yes, is a had great. That's of which JAVELIN trials,

as OS we the look, include we an conduct front-line in -- profile. see that's designs and such, will and But that trial people. example Our limited you for understanding as study if going to to really maintenance the are PFS outcome

disease control degree It the other whole doesn't address population. have on front-end and of or stable response We the disease. some

excited to entire urothelial more PADCEV population much get are of to metastatic try the we think and cancer. I

and that's those in endpoints our the operationalize So, we'll I obviously, with trial think mind. view

Operator

Thank you.

Our Shanshan Markets. next question with Berenberg Xu Capital from comes

Shanshan Xu

Can okay? hear Hi. me you

Clay Siegall

Yes.

Shanshan Xu

Yes.

that Historically, you acquisitions. very So, do I robust a believe ADC you have platform. rarely

a acquisition successful the is very However, Cascadian of one.

M&A strategy? your And So, follow-up. would you revisit one have I

Clay Siegall

Sure.

have for constant we a ongoing M&A. So, evaluation

to that things, for looking diligence. lot license. was a And And move we of have a lot say done the when of move we on I the first years really made a making We tried before were were we are of Cascadian. when could actively at looking. a look heck few you We time we

And went do Their a out of share. nobody we It license Wall govitecan Street really a sacituzumab And wasn't at had do time an a to $X because we acquisition. courts with from Immunomedics. which rationale Genetics. that looking out of at Seattle price was to It it. deal, like where or share the overturn was at $X was went a nothing

Todd did that stock did It prior the was which on. or position. more referred on position, of activity But not it. over keep of $XXX stock we made, to something courts I We million rule Immunomedics. CEO the think the of our

were it shows got yes, with deals the which able part got our license it overturn. you license had happy of was diligence. So, have it keep And to deal of that we that, we that if our power didn't. But would but on and

trading you with it. digits gave because I our focused Cascadian, the which was about and you that was And another next that diligence at was story time heard low-single not on company Street Wall

right. full very really and and Cascadian a regulatory became and years and that And struggled it a then as then product. and life a needed interesting staff it company Oncothyreon. a to power was to XX And that was this they and and it company, And with it Cascadian. this struggled was they done employed medical its Biomira started being company after so, or stay more and early everything became get bigger manufacturing had

made and yet, HERX took we could a that be proud the fully whether company – very to now, is this best-in-class with going so we into fair little argue their something from shareholders can't I argue but company that kinase. it I'm to tiny not is it's so, premium this a And and this tyrosine yet acquired approved a

the inhibit who could from the that. decades envisioning. kinase EGF that did probably that at and bind the tyrosine tablet One high trying you of associated potency to so had stay scientists that away to ago, with one we're make of receptor, GSK, to type TYKERB, couple And not were toxicities

what a we diligence. end, excited we And really in we're do job So, did. that to great

if but a we find deep But and less And don't you is and be stuff and can shy. find we not incredibly we often good we it that savory hype are go force. looking looks full And that out and something, unfortunately, of dig in deep that has initially, then going we sure But dig to means a lot lot be are that we out we there's forward. turn there we there out. that

bit to next acquisition going And what we to are want We we and go we Cascadian, this and now. you a do. a you, comment that's Todd or if and it. buy raised more any were little is cap it out we think bit we a little massive And revenue, to out have we little questions. also we the acquire we're day space we a bit more can went but transparent for to do we a When bigger, space bigger remind Not for acquire small and to that I'll have more that go company penny of bit raised do to a decided a to said, market could et more, very going try Clearly, company and not little bigger hard acquisition. have because money cetera. I

right want. will will you But away decide if go sure and Street buy what to Wall say, that be to we something, we we here's

Here's why we want it.

why Here's be. financially. how much to we in fits what want it And going and it's here's to here's do

the we way Cascadian. transparent, we find go it and will with then full something. will we incredibly force to we do And if work be So,

Shanshan Xu

quarter. sustainability going achieved thinking you forward? positive be should saw a just Great. of this that the profitability Thanks. profit I we How about Thank you.

Todd Simpson

we $XX of or in what that and Immu mark-to-market $XX think, reason adjustment the $XX question. for a profit million year. the quarter. the in the on had the quarter was was the resulted profitable for quarter you shares for because The That's billion we Thank million, had I the fourth

of more result So that please that. a it it because read don't into than was

Clay Siegall

a And we had quarter, three or important were payments had really we milestone had Todd that We a of that We four lot that got. certainly. one-off payments great mentioned.

with bringing is pull and no revenue it were ongoing that thank activity, when out different the in. brought that are There great we're streams -- But is not profitable. the -- So we all we quarter for you thrilled on the the a yet doubt. We not quarter up. was you mark-to-market, quarter. But

Okay.

question. Next

Operator

Thank you.

Our next Chad from Messer Needham with question Company. comes &

Chad Messer

afternoon strong and on Good congratulations Great. a year.

do ahead bit wondering And approved quite has ready. given just date. So, its real-time I you a for you it PDUFA anticipated got were PADCEV, that tucatinib, about that especially of was that commercially you When got ready do -- onboard sales When that. need tucatinib you've for you've be said review. of oncology for you fully sort think senior the you launch? leadership to

Clay Siegall

a you give the amazingly our little I'll Robin about with that. on talk could Maybe strong on So, tucatinib. making progress sales color we're staff

RTOR program, days we into use put one a is And only FDA, and BLA. went XX we in approval able the for And supplemental initiation the from at RTOR we BLAs. supplemental were And So, things that it we recall. ECHELON-X submission, told if to, ahead was that of this were pilot can and you gain can you was that’s a record.

still stands. think I it

a us on maybe some obviously will us program there, BLA. other that's beat Someone supplemental

to entity the added later, ability And bring program. FDA RTOR chemical a in new into

sites on but a chemical of we QC/QA review, said very to can that manufacturing. it's work need have the rapid having new inspections still need the you with a front of that, since entity, Now it get and all

accepting don't to criteria I with went move overall survival into that we it why say potential. FDA going the and be because ECHELON but very in standard-first for there things had can a in more the from strong know supplemental for that what advantage it's the that approval. accelerated to forward. RTOR. That's And thing, a XX-day that has it can potential involved we're So of is not I be X BLA.

can you overall advantage. tucatinib, I with And tell survival strong have we

would I company. the we've accept So, the accepted sets, tell are it to But the can't two FDA RTOR. can't they've in us that exactly had I I amongst you think of history data best the from -- what

for regard, lot they maybe of forward a that they're be something picky by move fast. and and So, to put being should effort

in with we're mind, submitted FDA. working So, that with we excited really Keep and that.

it We days to haven't filed. yet passed the XX where is

to coming future up file. that's in So where accepted not-too-distant from

hear working and we with in of So, I lot. them it us are that's with is that but they a FDA. you with effort tucatinib, from and hard effort lot lot are should a tell we putting you communicate the a about putting -- next of can thing

sales and readiness? Robin, the you our want about staff to talk

Robin Taylor

already Very happy to. We've let sales know you we've our team. that leadership hired

attracted they're is physicians from about not also sales but well. and things attention having many the HERXCLIMB excited excited of talented staff about the the that, data, about only data commercial One reps and it's as are great data other the

aggressive so very for the very strong plan that whenever in had have terms the great commercial hiring. that We organization. terms ready sure want is the a in a that of reputation we approval of Genetics And Seattle make are And may already news we to come.

all data And a that the is that of positions so strong across that, lot on top HERXCLIMB has in very we of of the have positive meant the interest have that we U.S. opened

hiring through number just make is a And one decisions. team. getting and sure our is the and we ready interviews will right I'm lot be for focused we launch. very a task confident talented But a lot us tucatinib strong now of so And to real very for of really have that standard

Clay Siegall

remember we but I where update I the already staff don't sales periodically. exactly last do I that the of I are, updates get And got; know two-thirds onboard.

to just And not a while that back was So, let we're ago. sitting you know, waiting.

that big full to sales it making staff really force are having getting we and So, progress at there.

Okay.

question? Next

Operator

comes from Wang question next Barclays. Gena with The

Gena Wang

Thank questions. taking you my for

Just two very quick one.

if regarding is very know one just can reimbursement average is wondering you give time. PADCEV. but it on process first The still any color I early,

What is cancer. second-line tried powered? is you how breast to naive first-line your for know assumption for patients and second question the And study I the both metastatic HERXCLIMB-XX. and Herceptin go is enrollment

Clay Siegall

Okay.

and your question is with start the and and that. too with patient average us say, here's soon paid therapy the your they worth to reimbursement. everything. let's many much able we all that and here to and standard is to cycles what ADCETRIS, gross and on that's into were So, and how how It net of here's for With time, really to getting PADCEV start

the We data. about details all we really therapy the of to are with time, duration ADCETRIS provide able with and had that but

do We will do there that. just to not yet future. the We that likely for PADCEV in are

was asked Now, HERXCLIMB-XX. question the second about you

And this about type so and line can talk of patients of that's the the that's first the Roger, we second trial have a at we and not So, to maybe that bit point. confuse it all can inclusion and with really original the about talk little be second could you HERXCLIMB. or maybe some exclusion?

Roger Dansey

component criteria. is And key Sure. they The a of the and seen have have taxane. key trastuzumab inclusion that's population to the

metastatic you or disease. prior And there it's the so circumstance, have will those been metastatic whether under session, in will drugs seen that to patients adjuvant be imagine can those two administered, have who neoadjuvant, that provided clearly

were will setting then that represent metastatic will therefore, seen clearly they who population. and those a in patients represent the and So, the have front-line second-line population

It's speculate proportion into trial can we assumptions what part the assure we we've to details, disclose excess just put on powering. I are, just for of but not the study. appropriately you, X But the that the part And around can't patients we've question thanks possible trial. based begun the

show that. So, better able TDM-X expect alone, TDM-X we if we tucatinib plus than to will be clearly is

Clay Siegall

question? Next

Operator

Thank you.

with Willey Our comes from next question Stifel. Stephen

Stephen Willey

taking questions. Yeah, thanks the for

Just in to that get slotted FGFR behind have going X X, your patients quickly PADCEV. guys FGFR are expectation that those Is alterations? the it inhibitors on you in

when for that numbers, on haircut with did your gave patients specifically And conjunction those guess, follow-up tucatinib. think, include I patient well? then you call, as And the quick a approval in I I a have addressable just

Clay Siegall

I you're assumption have know We the it assumption take. going do we're saying. not quick to is the answers exactly is But That are first for that our FGFR. behind two. the we not what not

patients. any out in not did And we so the those of pull calculation,

Stephen Willey

Thanks. would know Okay. the be that some might data. of guidance regarding kind tucatinib. discussion you there some is And was additional us on provide any I can there Antonio I be at just updates you then to there present able it? to when San guess subgroup that that CNS

Clay Siegall

Yes, impact brain few one the the we mean impact that are at doing there thinking an that getting. did a start in lot say, have to scans mets, direct is what tumors? and for with have Thank It's and is have actually of on look you're actually in cranial I to the can drugs about times of regard. really opportunity question. this a patients you so you PFS exciting you rare the on look work

it say want anything, would is but that work think forward and that much very would there present I pretty year. decent to presenting on well. say we we're strongly and published -- we type about something publish doing. And that. looking of this a I I And sure for work will want chance we don't be that's I to that want to to obviously, as But

Operator

Thank you.

comes Blair. with question next Our from Hsieh William Andy

Andy Hsieh

squeezing Great. in. Thanks me for

I just EU the am in labels So, proposed the comparing U.S. two and

the sorry, has -- two three. anti-HERX U.S. about regimens treatment this anti-HERX basically it’s is and So tucatinib the prior and EU treatment

can maybe populations So, talk function two differences you about between the a the geographies? it's treatment whether two just different or significantly whether are of

Clay Siegall

Roger?

Roger Dansey

thanks question. Andy the So for

in an the that difference from indication addressable second, we address So European the our in label the the based a indication answer versus to indications between the patients. EU today. is what U.S. the simplify that a proposing interaction labels, populations part We in on are is regulatory chose proposed got I'll that the early in feedback we're isn't with for that There faced the the and same. the EU.

in not the -- regimens. I paradigm. around this a treatment proposed is simplify approved is a we like the different patient indications reiterate, out But would be are space. final labels indication various It trying in in It’s key we these the also will with And agents words just point about to language goes indications not a just versus just that the population. and get not to proposed choice authorities. if different do conjunction regulatory will, the determined approval,

Andy Hsieh

Got Right. follow-up. a quick just And it.

best. of argue guess, probably that you see terms you understand the study, landscape Genetics the Seattle EV-XXX that could Merck I In and

combination the possible. get to out patients soon is as to goal the obviously, So as

curious analysis on that interim trial? thinking in Just your about

Clay Siegall

Yeah. not but say that we're now, it question, a today. one I would that fantastic is address right to is able

head. your that keep question in So

your active how could comments and XXX that it's something Your whether or discussion. is do under thoughts we trial something is and whatever on quicker, another in

be tuned. on back stay to So you that. We'll

Andy Hsieh

Got Thank very Cool. much. it. you

Operator

you. Thank

Oppenheimer question comes from & last with Silvan Company. Our Tuerkcan

Silvan Tuerkcan

my setting. could Obviously, what bound. finding dose lower -- like, maybe with trial, a these But on it TV. for how on Phase so on Phase from regimen cervical me X squeezing your you quarter Xb/X just ORR was last comparable kind that Ipi/Nivo given Congrats of be in. effects? thanks Thanks. might And the that data could in CheckMate has and which trial, cancer XXX is compare, two side late first a year question of focus data trial We've a seen contrast especially

Clay Siegall

my don't better it. head from data discuss of that I top the the Roger, probably know off can trial.

drug showed When I which need. KEYTRUDA. trial remember decent to medical is duration. that we you the rate was know and a from, huge add cervical response point -- Roger, these was unmet the duration can response when for some a last it to best to I we cancer, is XX% -- approved for patients have high of We're a trying show rate a thing? and as but want

Roger Dansey

and to so be that Clay's expect pretty scene the is combination it said I excited to a cancer. for way by great. We in Ipi/Nivo itself. But will sets Clay a stand that's high mean, cervical our what against. is. is approved, crazy. we I of for data there cervical as what's it's And move active And been need. in making and cancer it the Right. would unmet think TV, history such about forward measured think the I That's point

at any So, need to I'm not reference this immunotherapy combination sure that the there point. is

Silvan Tuerkcan

last ECH combination are share in and And would cancer in point. guess, progress, assume with we one it Good TDM-X. Okay. [ph] question. from I Could see ADC trial the take would breast future? making a maybe The and tucatinib I

Clay Siegall

a now the from tucatinib as kinase good I cell, HERX the think active tyrosine I we fantastic a trial. with question we inside be with to Daiichi inhibitor conjugate. combination that outside will partner and cell your the very refer antibody the whether could drug is AstraZeneca, of a the and of on think And safe hit is be very HERX on and drug directed active

it do it, investigator-sponsored it Daiichi ways. do whether does That or as we this independently -- trials, it's going in multiple to doctors whether happen whether eight

look data. to I forward So, those

right medicine. should the I be is think those tested two drugs together. It

Operator

our you. call to That the like to And turn for Thank speakers back I remarks. now session. concludes question-and-answer over closing would the

Peggy Pinkston

Have and operator, Hey, us thank afternoon. you good thanks joining for night. everybody this a

Operator

concludes Thank for participation. this call. today's gentlemen, and your you Ladies

You may now disconnect.

Seagen (SGEN) 6 Feb 202019 Q4 Earnings call transcript