SGEN - Earnings call transcript Q4 2020

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Operator

Good day, and welcome to the Seagen Fourth Quarter and Full Year 2020 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 Ms. of President Vice Pinkston, Investor Relations. Peggy ahead. go Please

Peggy Pinkston

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

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

Clay Siegall

good of and in with Europe presence business. our year geographic We Peg, past Canada and greater was for the and of you, pivotal everyone. TUKYSA. we the afternoon, United The as additional launches our Thank footprint prepare operations beyond evolution States across expanded

fuel a now company substantial company multi-product strength to investments. are financial We global with ongoing oncology

annual reflect our but first of product year. ADCETRIS dynamics, advancing billion. like We with ability territories to have laid in commercial need. cancer $X.X of in medicines Merck. were upon of We I'll well royalties revenues growth and financial our PADCEV and territories and strong our will collaborations, XXXX launches just $X in notably performance. a growth anticipated share past the us product strong continued see sales continued These which reported in XXXX results to and and programs. were investments, discuss approximately strategic positions partnership the us walk our a the will in We $X.X foundation continue ended increase. new which XXXX, with for as record with market to billion strongly over our bring Todd for billion PADCEV Chip to as successful and patients important billion TUKYSA with $X.X through TUKYSA start continued reflecting a by summary Total sales. ADCETRIS I'd our XXXX, sales driven expect XX% recent maintain included to In we XXXX and cash at guidance

ADCETRIS. business you XXXX, highlights During with a few I'd beginning delivered important and to like provide regulatory we with multiple milestones. development

more gained Takeda China. including partner Our ex-US approvals, in

from the clinically Phase in ASH data presented years. and cancer X meaningful robust trials a a five durable important in ECHELON-X we journey. This demonstrating remissions patient's is Additionally, at and at milestone and ECHELON-X December,

lymphoma We CDXX-expressing other are development committed malignancies. to maximizing ADCETRIS Hodgkin program through our patient and reach clinical in

immune turn class has developing cancer ago. urothelial we're This in Phase arm cis-ineligible checkpoint In data cancer its PADCEV ADC with results XXXX, studies. to that for in with patients Astellas. metastatic from accelerated adoption our strong in commercializing collaboration we rapid previously announced two metastatic PADCEV, trial single a positive shown I'll top-line year X a included Next approval treated FDA first from PADCEV an over just since urothelial inhibitor. and

the demonstrated a to randomized within with cancer. next FDA supplemental significantly few two trial Phase of and expect progression-free reported submitted survival a year, submit few top-line urothelial data previously Last also metastatic in in X survival care treated to also data We weeks. standard BLA we in overall these the PADCEV These to chemotherapy. versus and from results resulting patients Results concurrent BLAs next that will be improved supplemental weeks. FDA

designation are in these submissions marketing PADCEV in KEYTRUDA the quarter. cancer. In later metastatic with and we year, urothelial addition, trials breakthrough first-line to for combination received planned global therapy for EU last support this Japan applications Also in

the currently designed support approvals in to of one regardless other platinum to two approval patients, support trials enrolling in to metastatic accelerated approval are cis-ineligible patients patients support in We first-line eligibility. and global

the to treatment is patients cancer for urothelial around first-line redefine globe. Our metastatic goal

tested earlier Finally, with we randomized Phase in XXXX, patients. of exploring trials Merck, and cis-ineligible been significant cis-eligible has In X and bladder headway Astellas made and cancer. in invasive stages cancer bladder two PADCEV muscle collaboration in

metastatic received approval with TUKYSA's are States the potential as was TUKYSA positive breast Switzerland on to XXXX, brain in FDA's launch Orbis. without December, class further preparing opinion TUKYSA, HERX In metastasis. approved European the Now a best we United project its patients in also HERX well in Canada, under the extending and In as we for Singapore, TUKYSA commission Australia, EU and reach. CHMP recommending of a and for TKI cancer positive

the collaboration with to strategic a XXXX. entered TUKYSA in the Europe, accelerate Merck order in beyond we commercialization Canada regions into in and of Lastly, U.S.,

approved by currently in are have first best in three class that been Our oncologists. important medicines or products class embraced

their growth of received has Global investments We continued and mainstay its which of six ADCETRIS the development, believe future catalysts treatment patients substantial achieved penetration approximately in market We are around CDXX strong each in have indications. in lymphomas and and have that a of is were sales provide the will ADCETRIS brands XX,XXX nearly billion the in years. potential. $X.X world blockbuster making ADCETRIS therapy. XXXX

but our We will be Hodgkin believe We lymphoma of of expect hard is to which leading in future that current on by growth that we of primarily expect is years. indication. expansion ADCETRIS multiple the ongoing predict. become frontline in supported impact its few will resolve in COVID-XX, the has trials read time, to to care this labeled fewer diagnoses, standard that label PADCEV the out based next

in with further We expect PADCEV's of approved cancer. if role metastatic BLA the that treatment patients will strengthen both urothelial advanced supplemental submissions

metastatic this Looking support to period of approval factoring observe XXXX. cancer, supplemental accelerated complete year end in in response, trial cohort BLA could the expect a a towards first-line bladder follow-up the this of from we by enrollment in cohort K to data duration

on bladder Phase first-line cancer. metastatic the multiple In X in global trials invasive cancer enrolling in currently muscle basis as and urothelial addition, serve intended are submissions for to These large trials are three by as by the We're oncologists. basis. future. country well Europe rapidly important reimbursement that XXXX approvals seeking planning is an during launches as a TUKYSA medicine been adopted country in has

conducting pivotal several gastric we're in large potentially colorectal and trials breast, Additionally, cancers.

vedotin known our now TUKYSA is in to to in to clinical and for complete development commercial and of our product. programs patients continue our six the patients while I'll based enrollment with cancer and labeled ongoing TV Building Genmab enroll. on expect it significant our or will expand commercial reach known be tisotumab success ADCETRIS describe will TV PADCEV our programs metastatic portfolio. in BLA positioning also Roger patients even to a the expect and submission trial This detail. end vedotin cervical of in indications, We MOUNTAINEER fourth we clinical as announced late-stage other is in recurrent This Yesterday, with the future. of studies XXXX, the development that milestone turn colorectal as we to by for a more LV. ladiratuzumab our the further would Seagen on extensive cancer,

study KEYTRUDA co-develop a development active this collaboration global in focuses combination announced to is ADC Merck tumors. collaboration co-commercialize in and LV with accelerate hormone high year serve solid applications the recently also XXX intended cervical LV. highly cancer, and metastatic with evaluating the with on trial. to addressing and The as to triple and regulatory unmet initiated innovative with X cancer, negative the our Phase in the Aligned for of which We patients and receptor-positive global confirmatory LIV-X-expressing breast is monotherapy of support intended goal as last need we

we to to strategic are growth. beyond, on focused drive ahead look we As XXXX three and continued and innovation priorities

the maximize our to development of is first clinical global through medicines exceptional execution. programs commercial The and robust three potential approved

R&D to The early through second innovative corporate and products priority the leadership internal LV. strong opportunities. stage securing investments for continued approvals already TV development the third towards expand space, in is programs to late-stage and And including advance new and and is ADC our innovation pipeline

Focusing and key deliver on value to these especially notably employees substantial patients. aligned pillars is cancer stockholders, our organization will our strategic our to stakeholders, ensure

After discuss on Todd our our results the development turn Then Chip XXXX I'll guidance. year discuss and Chip? Next, financial comment the that, Roger milestones ahead. for will to to key and call clinical our activities over commercial will activities.

Chip Romp

a in of like our a a to Starting TUKYSA efforts received marketing Successful with quarter. colleagues our The patients to quarter XX% $XXX and was drugs product and all team outstanding million commercial relationships dedication delivered. you, Thank customer the year, commercial million increase creativity Clay. team closed two XXXX in X% my net XXXX. of task growth with the their would through reported over fourth ensure thank and total Launching $XXX full over sales year solid I PADCEV in year launches unprecedented ADCETRIS, successful and strong fourth for in digital times drove for products. a these sales strategies, difficult very we out appropriate XXXX. XXXX

see impact approximately to be lymphoma and continue XX% ADCETRIS continue trends pandemic sales based to We lower the records claims historic on on to an diagnosis levels. medical than new data, due Hodgkin electronic

early been durable reactions frontline and data of we these incremental the We share. advantage are data expect will Five-year to and important the trial promoting established an drive have standard now five-year favorable. outcomes that in ADCETRIS the are from follow-up HL, ECHELON-X

need sales XX% forward third to year and sales $XXX promoting our in quarter Full were of fourth indication for $XX X EV-XXX survival look million. the labeled and inhibitor. cancers. a strong adoption approval PADCEV, the PD-X increase XXXX. urothelial who onto million, rapid in meet quarter trial Moving unmet We received patients received observed Both metastatic data the would PD-LX of PADCEV an overall in Cohort or were upon have significant over indications prior a the Data

consideration in inhibitors into dynamics, our PD-X increasing market share indication takes or labeled frontline. the evolving guidance current our and use market Our PD-LX such of high as in

to positioned Transitioning confident $XX sales that the this are for increase TUKYSA; PADCEV were quarter. We a million. growth. sales fourth continued XX% TUKYSA over quarter year at third Full is well million, $XXX year were

strong call seeing TUKYSA and We growth in the solid. coverage continues were are the now its both across we settings. continue to community turn I the to see We to and be adoption academic pleased Todd. of with payer over will label

Todd Simpson

results extent billion, and fourth quarter that significant in Roche the XXXX the Collaboration and were million license $XXX billion and is by ADCs quarter Merck fourth this This important These of in for agreement and on Royalty to XXXX. provide fourth development the financial full the quarter for quarter driven royalties Royalty financial PADCEV the year which in Thanks revenues of year LV. financially were us Total for recorded sales This $XXX product million in full outlook joining call Cost have in costs utilize billion are $XXX Adcetris commercial the recorded $XX sales of reflects sales a and $XX TUKYSA million company XXXX billion our related summarize to for to Chip quarter of fourth I'll lesser thanks and of by brands of now $XXX are drugs. everyone XXXX. the million to are the our of the Takeda, sales of strategically, and full-year $X Astellas, year. fourth $XXX will the by sales $X for the in was afternoon. Notably share primarily of product collaborations fourth and quarter for million quarter. in $XXX XXXX. fourth the fourth diverse in for the product XXXX. XXXX. year. included million then each and included three Seagen the which the net first and deals million for of of sale This full our year million portfolio, profit four the million accelerate $X.X full for the was Today, which LV million substantial Polivy four for I'll growth year and $X BLENREP million and in in full XXXX. revenues year revenues we the this which both revenues and quarter $XX of technology. Great. in the were three for the time GSK and includes was by the included net increasing both for for with $XXX and a and the $XXX

in and pipeline commercial well $XXX stage sales to costs quarter our That In quarter the amortization of aimed full and the through as our $XXX fourth in SG&A items; development technology million fourth Growth in programs. a for non-cash at investment $X the fees use in of extending expanded products of second and increased acquired in as related related expenses over million quarter the were in earlier planned increases included were addition, began primarily of U.S. TUKYSA our that are per million approximately and European the was two our labels, the XXXX. year across and with of commercialization expansion XXXX year for later sub-license These prepare this of $XXX year. as reflected over million TUKYSA full cost we quarter. license reflect Merck. XXXX launches for and XXXX, XXXX. TUKYSA the agreement investment R&D million TUKYSA paid PADCEV of the expenses the $XXX

this the recognized quarter through for the two is recorded of with profit collaborations fourth XXXX, Regarding result the the revenue full our Merck. and new year in under

approved investment growth the long-term fourth billion and our investments, on to from to advance with This our of our Our products proceeds $X.X $X maximize strategy plans in cash beyond. in equity continues which the in strongly the billion Merck from quarter. investment to and ended includes We advancing remain year positions the us potential pipeline. XXXX in

revenue our financial I'll outlook, guidance. XXXX with regarding Now begin

and in sales provided what and around to $XXX be of term. sales the in billion. of approximately total First, $X.XX total the be million. we expect to and billion sales as This follows: in $XXX to Clay $X.X the drivers million, includes million PADCEV down the revenues breaks growth to sales range expect to brands product TUKYSA the range million each we envisioned million the be approximately of Chip of context $XXX we near range $XXX the for billion to $XXX range ADCETRIS to million. to $XXX some $X.X $X.XX billion, in which of in longer

them by BLENREP. to Next million, contributions $XXX of of in million lesser territory with a in range to to primarily and royalty to ADCETRIS sales reflecting degree respect revenues, the $XXX we POLIVY from be and its expect

are driven Finally, now dependent progress and collaboration ADC event upon by revenues collaborators. our primarily

expensive. R&D are a million expect primarily Costs these Astellas items. we collaboration We is Beginning now of of Astellas range range Cost the as product third-party sales. from territories. be by also $XXX share will I'll million. sales million across expenses than brands expected will in be be turn expected to non-cash driven to $XX million higher in higher amortization. be to billion, next as by reflect owed payment sales less reflect to all PADCEV profit $X revenues to revenues its year, result will contributions in expected XXXX. as This $XXX sales in of expect of a to a well two royalties $XXX increased to sales related and PADCEV of to

to we long-term additional PADCEV programs these advance to that First investment includes to nine indications earlier focus in expected $XXX We TUKYSA pipeline investment and expand clinical expenses to ADCETRIS, are stage a growth. includes to infrastructure growth that in into second increased important the development. trials our clinical $XXX and range investments of our SG&A believe in other be guidance execution our of commercial support are also million continue as on drive TUKYSA approved products. to Europe. three the global million to to This in launches to

we Roger. significant Taken opportunity for I'll will that turn guidance together, medical XXXX our see medicines approved for efforts And to develop to call continue we to that, new and that unmet needs. both over medicines the continue with our reflects

Roger Dansey

Today, since on at anticipated in superior everyone. long-term the fewer approved clinically ADCETRIS versus plus five-year ADCETRIS ADCETRIS we lymphoma. and compared and the update ABVD you, in X medicines outline benefit who advanced analysis in and in The treated received meaningful pipeline ABVD. PFS for frontline ASH ADCETRIS presented durable in who with key combination to improvement progress afternoon data resulted also we'll malignancies good the outcomes we those important in with Thank Notably, follow-up Beginning for second the our will primary has ECHELON-X those an ahead. when year the I Todd, continued ABVD AVD with provide regimen. Hodgkin recent reflecting programs, saw more with milestones and Phase are the pregnancies trial. seen

generally We with in patients these data a are young families. pleased the population with aspects of of

PTCO a immunomodulatory we forward ADCETRIS trials with combination DLBCL. and are see solid TUKYSA an for enrolling continue evaluating recently have lymphoma, in in as advancing tumors. to Hodgkin in and ADCETRIS trial, agents Going we Most multiple opportunities begun

metastatic the of patients meaningful death after shown this has meaningful in inhibitor. PADCEV a will checkpoint also X response be chemotherapy significant for clinically reduction in both ASCO Cohort Turning support PADCEV approvals. treated now among metastatic EV-XXX shown tomorrow who patients a were EV-XXX of death conducted checkpoint will to EV-XXX in from is checkpoint to a reduce with frequent statistically at received presentations received data presented with previously era GU. of the results EV-XXX X U.S. first cancers oral to ineligible patients use the urothelial passive, who who trial a urothelial the in metastatic and to full in of the clinically and compared Phase drug In XX% those data patients The risk new inhibitor demonstrated chemotherapy. PADCEV risk and to were the cancer, this setting global platinum received who authorities a rate treated cisplatin inhibitor. and quarter EV-XXX regulatory submitted and be and for trial,

approach complete Another in pronged approval BLA plus our metastatic patients enrollment program urothelial first this the data EV-X-X KEYTRUDA trial passive development for of key in of K the setting. after our to two ineligible occur cisplatin by to We And component supplemental the duration of receiving response. PADCEV could is in supportive plan the support cohort of end line are of as appropriate follow-up XXXX if year. cancer

patients compared trial, KEYTRUDA evaluating patients enroll the a to cisplatin PADCEV to plus continue which EV-XXX chemotherapy eligible X We includes into regimen. Phase global platinum containing

earliest initiated cancer trial in invasive patients KEYNOTE-BXX addition in combination Muscle PADCEV to As our ineligible to in KEYTRUDA or muscle we in known tell partners Bladder cisplatin-eligible as we Merck PADCEV is the the KEYNOTE-XXX recently ongoing cisplatin move or EV-XXX into with together EV-XXX. trial with of trial and This bladder Invasive cancer, Cancer. bladder stages us evaluate

for to cancer advanced invasive bladder trial examine in administered in directly in also PADCEV bladder planning are we Additionally, patients. non-muscle the

of in Lastly, have the monitor post-marketing continued the we to setting. in products clinical launch and of the trials PADCEV, safety our since

is but the Nectin-X common, and rashes mild in and as reminder generally a As expressed skin reversible.

information. however the prescribing do occur in are described rashes current U.S. the and So

who events have adverse in and providers the fatal with necrolysis PADCEV together communicating Stevens-Johnson cancer. patients post-marketing So patient reactions safety occurred litter, the being during we priority, healthcare of may occurrence cases updated toxic percutaneous urothelial syndrome by treated with trials. a with to recommendations and of With highest are treat the our these in patients including rare epidermal setting

overall the indicated for U.S. benefit FDA also We indications. and to these updates the balance use a the prescribing are favorable reflect regarding PADCEV data, supported cancer, metastatic provides with PADCEV in which high significant in remains to so overall our of information events. further, risk working approved benefits recent The need by is urothelial the survival an population. in unmet improvement most population with

progression-free of was at TUKYSA Cancer patients into San cancer analysis Antonio excited to to on and December, pivotal were survival receptor-positive in key trial abstracts. provided several evaluation we be or where the presentation are regard GI treatments program, response objective Breast With from new hormone clinical breast development lines HERXCLIMB regardless TUKYSA in overall consistent survival, demonstrating receptor-negative. expanding our to our and cancers. in Symposium rate A Moving hormone earlier the of featured into improvements the

currently So eight clinical this five of advancing trials end, registration have which we intent. are TUKYSA

programs, would I vedotin. Now one our tisotumab of to turn stage to like left

The metastatic meaningful data than months. cervical low with of of innovative standard median XX% demonstrated less nine cancer, to months. rates of the recently BLA duration women For have are who the response pivotal survival in first-line our X.X progress therapies ranging submission. within and six And durable treatment, XXX trial from responses included on response overall XX% objective typically announced and clinically median

fourth medicine with such at approved meaningful of a a need. to the motivated difference a that high cancer make metastatic could unmet are prospect patients We cervical

vedotin, KEYTRUDA. ladiratuzumab as with working LV, the to combination development are and Merck both to a accelerate on Moving monotherapy of with the we in

and Our includes basket breast receptor-positive hormone as eight cancer, well expressing trials tumors. program in negative LIV-X triple as other a in solid development trial

We progress weekly have LV the dosing schedule the optimizing the to extended evaluation schedule combination LV of are with of on KEYTRUDA. making and

novel ADC's function three effector and you of SEA to Vedotin now the have earliest two pipeline four stage antibodies enhanced use we in using Turning payload our which clinic technology.

would is highly look a novel Beginning now to to we Our targets summarize antigen, with the in Phase Sialyl like to ADC the most to BLA we on just This Thomsen-nouveau, which working is X XXXX. and important SGN-STNV. TV regulatory, enter submitted our are application. drug of forward tumors. across solid I carbohydrate expressed recent the milestones FDA some that have looking forward to with the multiple upcoming

authorities look TUKYSA and Europe hearing in by this authorization on end Japan quarter. regulators Additionally, regulatory forward in we from Europe U.S., will to be passive of the application, to our and the marketing submitted

the to Moving XXXX. expect K TUKYSA of enrollment trial the the the cohort in PADCEV complete to end clinical MOUNTAINEER EV-XXX trial pivotal activities, we by and pivotal of trial

We have confirmatory XXXX. XXX innovative opened have the our pivotal global in potential several we to and other pipeline across trial, trials initiate the

plan and includes in to we as Finally, have tumors data SEA-CDXX cervical programs as as multiple from data other from readouts This such well this year. data X solid Phase LV multiple TV cancer. than

I also forward multiple progresses. the candidates year We novel further product INDs developments details have of to year. plans during and sharing for the as course to submit look the

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

Clay Siegall

Thank have made of the challenges past you, we a proud of progress company I'm as year, Roger. over remarkable the COVID. the despite

company We better been and for growth. innovation and has execution, never stronger the have stage of for Seagen's the and phase positioned next set

line more broad powerful open need We the ongoing geographic for pipeline, have interest for to will an Operator, increase turn and Q&A. ability everyone patients listening Seagen This commercial I expanding and globally portfolio, to reach your this a thank would to in please strategy. partnerships, therapies. footprint, who lifesaving continued our call cancer like in support. deep focused your

Operator

And first come RBC from will Thank go you. [Operator Kennen ahead. Capital question MacKay Please Instructions] today our Markets. with

Kennen MacKay

on is and wondering the what that's guidance around baked into of on congrats just Thank comment expansion all geographic expansion TUKYSA XXXX, you. just Maybe indication and what a progress in current question PADCEV, invitation? for can that terms that's whether upside on for the the or if taking based you for and on or there's the year? thanks anything just that Hi,

Clay Siegall

question. for Sure me, the Can you hear Kennan. Thanks Kevin?

Kennen MacKay

Yes. Sure can.

Clay Siegall

Okay, good.

to sure. So make

questions through are excited largely ask have PADCEV drugs all the – either we COVID. PADCEV, all through that TUKYSA or TUKYSA we're of for launched and three about and largely You first has both and approved so really been

standard we're advanced PADCEV. patients reflects? platinum bit come on It very to we've had the a with good guidance Chip, cancer now with a way launch so you So progress. give new – PD-X drug for it on of to that. and little and had care would what to who've up like and really great urothelial We've color of shape received we're

Chip Romp

Sure, Clay.

the is ongoing marketplace. treatment seeing So PD-LX into utilization in an we're patient PD-X monitoring PADCEVs changes expanded population. and essence of We're the of move which a of frontline, the

driver a we for use. in that's just and full a to with we're patients So see focused continue both promoting breadth XXXX. With to XXXX brain increase that of utilization without, we label regard TUKYSA so in us the on for key metastases patients really

Operator

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

Geoff Meacham

tolerability? cohort Afternoon, guys. Chip, duration guidance. And ones. let's also say couple from equivalent ORR, better what's quick that or Todd first-line Roger, this then just of PADCEV K, question. look on Thanks the but chemo from for ways the for I on had opportunity win you'd expect the you and a when at perhaps normal response to an are there is of

is continued could Just be there which of headwind COVID quantify Thank much and way wanted at tease products to you. it or from how a ask to is out reflected affected? least a

Clay Siegall

both the thanks of questions. Geoff for

little think the Let's actually you'd where have story two start trial talking about we can on a Geoff basis. with trials, bit frontline you discuss Roger on PADCEV but that like frontline but frontline, cohort is Roger K, to I what focused

Roger Dansey

Yes. question, and thanks interesting It's one. Geoff. an Thanks, Clay Sure. for the

with – of subjects, the a generated than around is care. inflammation they is course know to trial, rates we single as of know, – as response that data the absolute anything ORR. generate data It our give is of So has you regard substantially durability. durability, so PD-X arm they standard XX better a will when the to Obviously KEYTRUDA you you remarkable. what's The with but that think have one on is hope and out. our the PADCEV the expectation, really I with could important be won't hallmarks, With we've inhibitor, play is equivocation one

outcomes often DOR long-term that sort generated in as it's I don't the date. it's response think remarkable. such tell. have reasonable story compelling a So equally standard measured are a because of so month PFS I is high not is in to specific as in we'll it's With and a if as for seven but we have survival better reported, the chemotherapy, progression-free a even period. ORR The data you number for generated can to overall we've durability far, hard. recapitulate Again, degree of

Clay Siegall

headwinds asking everything every we And remissed with COVID a – I trials you're would about Biotech potentially think guidance be clinical article to company there. in enrollment. then COVID certainly days normal there the how oncology Geoff, last a Fierce is in – down little bit was perfectly on front with XX% with and about two mean, the within are I big say

doing are or coming to I understand XX% in Also with, of get down, patients certainly but running during not example the clinical just older difficulties therapy, trials We're well. lymphoma whether COVID. first-line in cancer. bladder it's with patients Hodgkin Ours guidance, for coming

done headwinds, there's some great. we've So certainly but

Chip, medicines per the our you'd you I add, you like then to or really they'll any great. if Todd, start think to, like out. guidance as would with Chip and COVID on getting headwinds? it'd be exciting thoughts Chip something we're have

Chip Romp

no from with to obviously to difficult the but There's have I far. it's that emphasis the digital and so results have regard pandemic. you headwind, been that it's we're our of promotional place that, pleased doubt with lot to what's a we teams mix with take adapted predict so we're we're tell marketing the We've standpoint, going an so that Well, putting a on Yes. would altered seeing efforts. well a the

Todd Simpson

little a with the of of think TUKYSA of point, can harder like maybe to experiencing it I marketplace. We talked and medical with I'll rate little to a calls a Hodgkin But With in those to has data all Todd. about happening it's little with previously bit a pain records, electronic seeing to now few talked diagnosis exact is Clay's things lymphoma. this easier like add to pinpoint bit in COVID it's a review what's causality. And and ADCETRIS, for correlate frontline a drugs about through COVID. get we're PADCEV; couple Chip thoughts. reduction effect respect of XX% about that we're Yes. we've the

all with back in pandemic resolves, it's thing just little that to when as hopeful will Now on, about a hard to I speculate get we're to might normal that things bit. that but This mind, happen that we're come think the hopeful behind. we're

Geoff Meacham

progress. Thanks Clay. Congrats the all Thanks on guys.

Clay Siegall

Thanks, Geoff.

Operator

And our JP next Kasimov question will come with Please from Cory go Morgan. ahead.

Cory Kasimov

that well that terms of mentioned doctors rash as how the cycles good I seeing a market on with one curious now, you that's the alerted patient an over have tell real to, kind if world, guys. number of little in is treatment as per sort taking any question. on that year Thanks the Hey, front? of in for cost more of product impacting way Roger, evolving latest the the afternoon you. things patient. annualized seen you And us the the and Thank than you've the of per on in you're can and material you've a for average PADCEV commercial

Roger Dansey

thanks the Cory for question.

I treat really were think far there, discussed costs. – people, really and how we out like the As cycles patients it's as different long we discussed that are a in general average but lot of for that. We annualized we've the don't

So you – the setting, Chip, would this little information relapse talk the give in frontline; them that. with is some PADCEV? not which the we in bit cost a like current roughly on this is per about our patients and label. Clearly to is

have you comments that? Chip So any on

Chip Romp

Yes. I do, Clay.

and associated just are with to about price were XXK net with, patient. per kind of be $XX,XXX this discounts – I to given ballpark associated if net gross So that reflecting it'd

Clay Siegall

Yes.

you. thank So,

right. about So that's

And size, cetera. usually XX,XXX; patient and It to the et am about so are. where so depends on their we people XX,XXX somewhere the really me, it's in when ask I

USPI, has have target. we're tumors On in the to our tumors described on some Nectin-X like and study, our including some antibody. about we It – rash, cross-reactivity. tissue the severe. other initial question are we buys some you crazy, great hear you'll a it And urothelial especially also like Nectin-X is almost that And more normal screening. that reactions, basket that every skin about ones but binds

cautious, And of is. that some get doctors the warning are the there's super aware section have about what and so skin we've rash this a we well so known in that patients and

most the about. it we so write home call and much of too And nothing time it's out to

that presenting think XXX We tomorrow. in severe. more that overall gets which favorable it we'll shown survival very Sometimes the a be study, has the through and we've risk benefit data

one think and look this. really OS doctors if And the really see goal drug And something benefits, watch is, anything almost whatever the they don't put of to best aware you in – thought side of any that's doctors case put as you could so want to there's cancer the at it So can question. have they Roger, when an drug know looking used all they to the And disease, – patient, any of light you sure forward any to drug. of in that's or against to. drugs, are any the of effects because effects the could safety well has number need that I issue. rapid this, about… having make And to that they hold are our And manage for with answered control aware try or on weigh to patient we using happening every that your side is it. to it is are that the this that that do if to. correctly do

Roger Dansey

therapy. does occur, with rash sure. does question Clay And and does durational right I meaningfully is I generally points, mild Cory's No, therapy? the has transient. And which around, think, it actually think not this made impact it's interfere

obviously For needs rare events these the to discontinued. very drug be

events is the low. any would those frequency just of discontinuation, So bad but require reaction

therapy used in of way, being don't it's that that changes we I the currently this or yes, PADCEV the believe any think at. used is length So way

Cory Kasimov

Appreciate Okay. it. Thank you.

Operator

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

Salveen Richter

for my Thanks taking afternoon. Good question.

Given on the guidance what us indications additional for share or Could indication year? this will when on board PADCEV the incremental be the comes on-label board help market come you only includes use. understand

Clay Siegall

report top the about global trials this. they ASCO call it's is we GU, the the the CIS-ineligible what Roger what be study. the and we frail or out the we happens, one weak more question. for the first to which our And the more so submissions; study can we the two And second line we at investigators. patients. XXX it They called is is have were patients These both you data, today, deserve cohort to which talk right tomorrow. thank study, and the then our maybe, just Salveen, save second the that of cohort X, patients. is those you of at for presentations conference but tell tomorrow present We could mean we'll by need put wish we which

full but to it be data all that. tomorrow, we're So sorry, announce the and ends we'll tomorrow up

So look this. we'll and for present that,

trials you color to could Chip, Roger two this? docs balancing you a add talk label can think start in new what to you give and using outline here about maybe these be maybe for be kind So doing? and you about market what little little then, would a off-label any want managed, just bit could Roger, what could of

Roger Dansey

Sure.

of EV-XXX a trial recapitulation randomized is essentially cohort X. the So

And followed is inhibitor. in the its important against population by standard same survival the outcomes. chemotherapy a standard obviously or PD-X And who've is overall a it's a of patients improved terms suboptimal is platinum So that chemotherapy. that outcome seen therapy PD-X

physicians of population. population a survival patients, already ineligible. more overall for we evidence. think of differently enough support by before their proportion the time in at different using data deems half a PD-X initial is this about than of other eligible. a this, is cohort And agents a therapy the general level that an Those a we population, or X, it made PADCEV's It's or efficacy to compelled maybe complete is although bring the a – required So have It of PADCEV more I disease, is this think population. of react we're who, is around of some decision that affirmation There chemotherapies. an obviously, value our signal frail drug, use. the or isn't carboplatin to can rather really that data. terms population, than cisplatin metastatic like alternative older With use regard will the then excited PD-X that to a cisplatin believe is to inhibitor who by And obviously

and very there including demonstrate outcomes. PD-X then produces gets And first PADCEV So population see that mean, outcomes PD-LX line a the treated that is that response hopefully duration overall of response treatment, durable does you'll a like in that and tomorrow is effectively or and clearly find day that excellent response, and situation rates that. compelling I

urothelial and on So say quite I that may the make the armamentarium they the we of checkpoint exact a think think define; because to that you to reason, we cancer. any have may difficult for suffice are for add Chip, size good in comment to inhibitors do manage physicians population, meaningfully But be sort comments? as that Chip of difference. they metastatic cancer that widely used

Chip Romp

it's and as an approved would think an I patients, smaller segment offer population, we're option that's And patients. I I is, nevertheless the What a important important unmet forward of Roger, once to a looking for that PADCEV but thanks to. add think of number these I characterize Yes. could meaningful would this need. what

Salveen Richter

you. Thank

Operator

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

Matthew Harrison

just ongoing speeds hear expect I afternoon. could the may Chip, if was at we see in potentially. Thanks that expect from of of or comment Great. resolution this that to question. just you year, us whether patent Thanks. taking the for on this you year all what to Good the any have wondering terms you arbitration

Chip Romp

So, thanks for the question.

not better litigious to say and a we I first remind – almost – you the that DS. a dispute this. two there's time company, half like will of something is I So more and legal a that's you tell our way we've that with lot with this a are work decades, it, had ongoing the will

not our so this goal. is And

patients, a we're defend to really make is contracts. of to and Our but cancer IP goal in the compelled difference our life our

are contract is a is so, infringement One a going things about And on. different and suits. an two one patent arbitration there

confidential, an but I in it's are stretch. those you, to not there's So both a on is very of any it all it. play, sitting of both and of but – so activity lot those still attorney, can't by active it describe and I'm legal are not

effort but some deserve we case. at and so that And what case. know work don't I I'm we'll but a fast we love it's year, please would fantastic a there happens, so not us – I assume that. stay I value and It for how thank think I to along can't We that But you to some things – certainly tuned. that. have and is something I we resolution And this feel are this straightforward – we so arbitrators on really well moving it's promise you see on question being is completed work. – see point. that hope courts mean really the and

you As soon bet, we say, to you'll be have as something announcing it.

Operator

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

Michael Schmidt

guys. taking my for questions. Hi, Thanks

in you And heard at might programs last help think I early CDXX year mentioned of here. could year. already some disclosures updates if think us that But how the your one you Day with interesting your stage just seen curious inform? expectations data I with of we've this data R&D I and earliest at terms

Clay Siegall

It you. hard hear Sure. was

SEA-CDXX, He really sometimes antibody. just anyone I drug the about elegantly It tumor and the have the looking which a hear. a that added is through simply, at drug an I'll terminal very it asked we antibody can but being basically it's manufacturing, SEA SXX, properties, antibody for is to it conjugate. what – populations. technology, And call some fucose question non-antibody which function didn't be extraordinary effective an competitively through it from to helpful is call who So repeat our you're which depleting inhibits makes enhanced if

in it's talked interest and not say about but way antibody other And looking it. it so by that any I it's this. at have I've an empowered And of an ADC,

we've me I it number of certainly drugs so, bring don't SXX interesting for that know interest up a And if And drugs trials. made usually don't really don't you drug. a time, long in. a usually, And – developed I very early think haven't that I past is I have

year. We on that data have to this presenting committed

to the – it. been I am data in excited where So I where that's really pancreatic be cancer are focused work. will we've we complete on on. the

have lot patients One look know historically along. than been of it's to some other see the far could hard that panc, a things at disease you it's with symptoms pancreatic until treat. cancer, It's A too diseases, the different of pretty don't have obvious they're until you if late. and they which disease

So new unfortunately medicines. that cancer disease pancreatic is treated needs really poorly a

cancer big And of patients' so has interest couple the decades we a such exciting a of have always have things that's one now difference pancreatic a to in disease because that making in for I been and have had a treat. lives tough

interested some historically, but was pan in we excited studies – can doesn't early And I do see these was I folks hence we're and interesting a data difference it it – then if make in, we that or cancer lot patients' out. So that see and and larger you the if two you calls to where lives. at look and mentioned in there's pancreatic very one a early times of data

you that's repeat if them that of to history, learn lessons something don't again. the you're so And doomed

certainly So that. learned we We've it. have watched

handle really early responses are, maybe good interesting, exciting try impact dramatically it looking we on early And so very some survival. what even and pretty duration, a – took expanded of this exciting what's to we've the at to get our data, way

as – the data what we as see we the come data, data, what the I'm and question happens out, when can are is to that then next. at the best hopeful we means. as really the And then the data data So And we report decide when the announcing report for? we data trial. also your know what But pivotal want to mention about have yet, and a for? Roger, other question do we you not we're look they don't exciting you And I look guiding. should any not thing we're it's what go to that, into and robust is was look should

Roger Dansey

sort cancer and together those other sure are with it presentation those the a stimulate interventions, PDX – we had hypothesis agonist, way, and construct, a testing frontline of a strong this the mechanistic off combining brakes of kill by we're CDXX make just from good chemotherapy in is There's cell chemotherapy, three sort preclinical combination sort that the we is that Abraxane a CDXX clinic, have have agent activity the think other all together of in the but single taken antigen perspective, any gemcitabine-based a diseases, the I are repeat evidence data. with already the which The one. with the we of then things, scientific which of chemotherapy And too of the inhibitor. with scientific the are in some T-cells.

strong very scientific it's hypothesis. a So

As we've a said, enrolled number good of patients. Clay

our data be. that the at for next as to wait our And what point could we'll steps readout. will We determination to make

Michael Schmidt

Great. Thank you.

Operator

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

Unidentified Analyst

behalf is for Thanks questions. of This [indiscernible] Hi. all Gena. on our taking

guidance, higher? assuming XX% are you one range in this Just another what mentioned What about guidance? remarks, high like share sales Or on PADCEV. a are And XX% that is to share. their U.S. one your two type on TUKYSA XX% talking about on market PADCEV's to prepared considering Thanks. or all of In revenue guidance. high current the on very of talking quick one XXXX? market – Could you you even for comment predominantly are is we OUS we

Clay Siegall

Yes.

what's talk numbers like every asking, into that's the specifics it's your question on the something percentage just specifics going then you we report for because And of important. that. you once everyone and the thank – is So start all we of percentage, – share usually market really on about not our quarter percentage what's kind and that's

we comment with he a a feel make PADCEV. On he to think I like to, Todd and its can of on share wants this doctors what think Chip, if TUKYSA guidance, the make care. I'd of And standard so with on. And market comment the and

question revenue in and what's the asked U.S. outside included guidance. about You

we why for don't guidance on don't start the why Todd. you start there So Todd, with TUKYSA?

Todd Simpson

Sure, for question. the Gena. Thanks

of that majority is for base. So starting but majority the Europe Orbis, And U.S. countries TUKYSA have is forward vast U.S. do Project broadly approvals vast year, guidance approvals next our under sales. in we looking a of we're other TUKYSA course guidance and the to our and few to do in of

Clay Siegall

that. and going PADCEV and like the stuff want market give on a share And little to Okay. you then on Chip, to back do color that?

Chip Romp

Yes, thanks, Clay.

a in I changing market well dynamics. that XXXX say very point a as standard these we're to would in of So, positioned intersect with care, important

see in that's you're frontline. to going PDX PADCEV I to I And increase the going position. a in to PD-LX favorable think continue think and utilization put

Unidentified Analyst

so Thanks much. it. Got

Operator

our Hsieh Blair. And come William ahead. with question Andy Go will next from

Andy Hsieh

banner squeezing XXXX. for Okay. me to a Thanks for everyone in Seagen in. at year Congratulations

paradigm I everywhere It the overnight. for cancer So a had stage basically early question in of kind whole like bladder cancer seems you bladder PADCEV. encroach guys treatment

typically cancer, have So some invasive non-muscle in supply. – with been challenges BCG there associated challenges the bladder

broaden wondering as just basically So at just opportunity you not use at of – patients are I'm the beyond for there? suitable you intravesical looking non-responsive, are the looking for are BCG well who kind

Clay Siegall

on, talked going about Yes. Thank Roger and all we're lot muscle you on lot our for work the that question. were we've like invasive, going is done say, where we you a as cancer metastatic, really a whether it's but of have in PADCEV non-muscle We about, excited of next aspects bladder there. invasive area after

you started use of well haven't on aware Roger, want of to little we're give a We're challenges. yet. the the intravesicular trials color what do thinking? BCG We

Roger Dansey

the activity in systemic question. in as programs generated we find until in prepared obviously I won't Again, all great plans, any like bring balance know, into invasive that we profile to the place we haven't we or Andy, you Yes. a bladder and it's in would active we wherever how is clinical unmet for lines risk to We bring The the are but much move PADCEV just can we aspirationally of it's tell have do if could versus start, we we based you circumstance. can if data And on can as the beginning into of non-muscle be a of earlier directly PADCEV for is planning. we remarks, have it's PADCEV we bladder. think to on address very make to much but exposure Obviously, cancer but we're advanced need. to bear disclosed appropriate favorable would minimal we move therapy. are – trial plans say, benefit population, the BCG positioned the how we non-responsive, in and

Andy Hsieh

you very Thank much. Okay.

Operator

go from our Please And come Berens will with next Andrew ahead. question SVB Leerink.

Andrew Berens

potential checkpoints a you increased rates there's or if rash wondering versus PADCEV was I severity of with thanks. give for PADCEV when Hi, alone? skin increased

Clay Siegall

data very but you as trials we We're on Thank we you – some as presented ongoing that. actually have know. you in much question have that's for now on can comment this, to been trials. the Roger,

seen we've so in the and that – anything a And fair – that data be perhaps is game, on talking going the about to Roger.

Roger Dansey

Sure.

with trials our There Andy, XX and it's And potential carefully. today in, of as muscle rashes metastatic, we bladder reasons monitor we subjects plus a when in circumstance powerful overall lots particularly plans and From of KEYTRUDA combination around are has believe safety that trials. as based The report twitches we're you we changes with data no believe to grade clinical there's we perspective, in to regards that invasive in are in a did cancer, we tremendous where to clinical ADC So, we vedotin confident scientific that [indiscernible]… safety know, obviously any PDX we all believe just our inhibitor. presented a X run, but what doing skin combined the maybe not PADCEV well. of the

Clay Siegall

me? you. lost I Roger, hearing you hear just guys Can

Chip Romp

to Yes, I Roger. think it's related

Clay Siegall

Yes.

Well, Okay. lost Roger. we

So, Andy, are you still on?

Andrew Berens

Yes, here. still Yes. I'm

Clay Siegall

answer get you of Okay. Roger? from Did enough an

Andrew Berens

the I to the about patients. just think talk was data he in XX about

cut So unfortunately. we got off

Clay Siegall

off. Yes, so Roger got cut

not there'd the us be obvious Our problem did a in to that that show all. was anything data patients at

shows patients and trial in a the that trial. well two together both and the It opposite. the lot the breakthrough of the patients been got it drugs we're accelerated shows enrolling fact, did we global designation we've – incredibly In on and

pretty And I we if excited And now, for. from would don't looking I you're that's forward any reason know that be so, sit where on we're inhibited this. what know darn we going

Andrew Berens

and No, more as be the I is commercial if just or in more could a interested frequent worse issue. rash it of was more

Clay Siegall

Yes.

have We seen not that.

Andrew Berens

Okay.

Clay Siegall

seen trial on, that that. the we've In have not presented we

Andrew Berens

Okay.

Clay Siegall

commercial that's no what at this we We big with forward these, a we've don't you so study obviously have to do you going see point, with for why but date the to and commercial and issue seen limitation with see in combination see we'll any future, studies that… potential

Andrew Berens

you. thank Okay,

Clay Siegall

I PADCEV up well. very to it’s quickly. become in of exciting setting mean, taken pretty a We've metastatic care standard really see drug

Operator

will our And question come next from…

Peggy Pinkston

question. one for time have we more Operator,

Operator

with will Oppenheimer. Jay question Olson Please from go that come and ahead. Absolutely

Jay Olson

thank the and and three portfolio, to update. building And all pipeline traditionally TUKYSA Hi, global since global through you the appreciate from which the the I global have potential the your in eventually strategy congrats progress and ask to on you your maximize partnerships early outside done commercialization for of envision all U.S. your plans wanted pillared about you building Europe, development way registration you're now, your infrastructure you and through independently? a taking do stage you

Clay Siegall

lot is greater the – that thank of a have backs first back TUKYSA TUKYSA expanded we noticing quite which Jay, you of on include the Europe, So, Thank of to all, for of for on the question. you countries.

start all work is Asia, really far with don't to markets, and the ready patients as in I It China. working especially to biotechs team past docs that pharma and mean question. is matter that biggest for ignoring that let's just our a of And is there But lot We're to that, a as out certain and parts say for so two soon. the what of depends. this hopefully easy would not in and to U.S. U.S. sometimes do to Japan be your future or So go. getting need excited say it I there,

and some drugs do markets. we're big at closely at additional it Asia, that we so in would for looking instance, what we to the something of consider And putting with would as is whether

we're to that's we're to partners you, distributors do whether know do I all everywhere. And at out distribution and or in of pillars different and yes, talking something broaden hope so tell don't partners. that about. a want look the our have our want in going We We we have great as going no. I'm to it global part territories you glad way. we to continue reach. something I is really a that broader or we're But commercial And best partnership

Jay Olson

helpful. Great. That's super you. Thank

Operator

over to the question-and-answer turn conference the concludes this like I'd management back to remarks. session. And closing for any

Peggy Pinkston

and look in staying Okay. hope to We thanks joining us have afternoon. Thank touch forward evening. for a and good operator you you everybody this

Operator

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

You may now disconnect your lines at any time.

Seagen (SGEN) 12 Feb 212020 Q4 Earnings call transcript