Earnings call transcript Q4 2022

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Operator

Good day everyone and welcome to the Seagen Fourth Quarter and Full Year 2022 Conference Call. [Operator Instructions] Please also note, today’s event is being recorded.

At this time, I’d like to turn the conference call over to Doug Maffei, Vice President, Investor Relations. Sir, please go ahead.

Doug Maffei

Thank you, operator, and good afternoon, everyone. you fourth welcome results XXXX to call. conference pleased to quarter Seagen’s financial I’m

issued release on a The we and afternoon, This press and the section, slides Presentations in page. press with supporting are website available our Investors Events release results. our

Vice call Officer; Executive and Development. President Research Commercial on Roger Chip today’s Chief Officer; Simpson, and be Dansey, will Speakers U.S.; Epstein, Todd David Executive Romp, President, Financial Chief of

keep this our to questions. to call Following everyone remarks, We ask participate and our the we’ll one to Q&A in give yourself to for line call that prepared open to an limit hour opportunity today. during one aim you question

and the SEC. for the Seagen with pharmaceutical Exchange and the and revenues, expenses approval Securities Company’s costs difficulty the regulatory XXXX, about statements approvals may Commission potential More potential conference projected from is milestones, by the product performance. regulatory that outlook, Factors contained caption subsequent in the the anticipated process. filed marketing future results anticipated or and information results, the with Risk clinical under with uncertainties implied development Difficulty] include uncertainty including difference materially Difficulty] or data and the faced XXXX readouts Today’s differ filed developments forward-looking in and risks Factors events those or and cause costs a commercial such forecasting quarterly and statements. may quarter forward-looking the [Technical included and submissions, financial will in [Technical XX, Actual sales, call regulatory expenses, regarding including ended include and September reports associated Company’s the Company’s these and

call David. I’ll turn over to Now, the

David Epstein

afternoon, Doug, everyone. you, Thank good and

commercial product XXXX Today, entire of reflecting nearly uptick sales included revenue $X.X net record XX% growth we across billion, driven our billion, over portfolio. meaningful XXXX. This by reported $X total of

into share optimism and in guidance sales market our gain to grow for newly existing Our in labeled ability indications ‘XX indications. reflects our

last first, In at will like for But accomplishments. an begin month. noting XXXX to the you we a few year Healthcare take I on moment, through strategy I’d exceptional presented and Seagen reflecting a Conference the JPMorgan by

decisions Beginning received in We positive for trials XX with resulted across robust including commercial that development markets. our and pivotal have now potentially countries. label reimbursement our completed commercial our in PADCEV multiple enrollment approved presence already We franchises. regulatory four in and expansions registration-enabling approvals results we delivered products, TUKYSA have studies in two progress for two and brands,

and assets, drug like new broad potentially prioritized a including the studies X programs advanced pipeline candidates. DV, recently initiating transformative at differentiated same multiple of We for SGN-BXA SGN-BXHXV, time, Phase while

are also that multiple agreements corporate development Seagen into complementary for entered assets to our expertise. new

T-cell gamma bispecific engager development multiple example, exciting rights EGFR we into and an with solid novel to global preclinical delta tumors For for for entered the of ADCs. collaboration expressing a secured Sanofi

on or focused Looking we ahead, demonstrated of clinical benefits. real-world best-in-class three focused our are and of products, portfolio pillars: commercial the the is optimizing full first first strategic potential on

commercial programs, could our significantly and spanning opportunities areas brands well. we’re clinical tumor execution potentially across in robust and executing broaden including These multiple enhance In patients Here, to need. to new types. development in approved meaningful of their footprint for we studies are working products approved registrational labels more our growth as our XX parallel, unlock reach

to and in blockbuster continues reach markets Reimbursement pediatric U.S. important our frontline ADCETRIS recently their the care to deliver and standard value is demonstrated in Drug our of with further its partner, approval of has in following to lymphoma, the in the in XXXX. expansion label quarters added status XXXX of a territories ADCETRIS ADCETRIS data China. expected record seven Takeda, in of label Canada, sequential clinical Hodgkin international List three National a U.S. is Outside readouts, U.S. late the product and year sales. indications was last and

I’ll brand. application which and cisplatin-ineligible accelerated combination of now the FDA turn to review in patients PADCEV, blockbuster action The cancer target that KEYTRUDA our XXXX. we the an seeking metastatic for priority approval granted for become XX, believe a of for bladder potential April has to PADCEV with first-line are second date

representing to program bladder of is robust includes earlier development Our both, stages invasive goal potential into muscle segments. clinical non-muscle patient And advance forms, our PADCEV’s even cancer. larger and utility

evaluate We report to data continue year. study from this solid bladder expect PADCEV and to later cancer the beyond tumor

the partnership Astellas, to globally looking in also other with expand countries, approval following and its We’re EU in PADCEV Japan. including

This to launches cancer, XX the metastases. to progress adults in provides brain benefit particularly approved TUKYSA its those TUKYSA. HERX-positive countries, Moving significant breast country planned use with continue now make we of is and multiple U.S. with for XXXX. expanding on outside with brand metastatic in

colorectal cancer, NCCN outcomes frontline and the modest to Last therapy. approval as is subsequently treated was progression previously patients month, an poor with TUKYSA important guidelines. have on received it metastatic typically for accelerated following a size HERX-positive but added population patients This these

TUKYSA program is Kadcyla, as in drug cancer which breast ADCs Our development HERXCLIMB-XX. used a includes a called with combination second-line plus trial in of such metastatic

outside reach with also partnership Our the Merck Canada. extends U.S., of and TUKYSA Europe

top marketing year-end and are X as as expected well trial advancing with in support second partner, that is and important the a cancer. data regimen cervical TIVDAK metastatic international continues commercial treatment now is serve preferred Phase the a subsequent product We confirmatory or recognition trial to could an our option XXXX. NCCN as our for Genmab, recurrent authorizations receive line for cancer by a or cervical as potential per TIVDAK newest guidelines. line U.S.

near will business. Examples will to have receive prioritize risk-benefit help clinical that most portfolio we global across the entire unmet assets global our patients and medical priority of critically the the prioritized assets Based development of need optimizing data, that portfolio. DV, chance rights opportunity. discipline are transform could and upon programs this company. are and we ADCs analysis, full resourcing These second potential Our have is indications programs, and that success, BXHX. transformative prioritization potential Seagen pillar economics on flow believe We or most the a impact initiated strategic to and recently access promising to our our that BXA of large and reward with balanced patient

Importantly, we remain of given ADCs and focused anti-PD-Xs body demonstrating vedotin the data cell through on immunogenic clinical the of combination synergy death. growing the

trials have we such, combination. X As this exploring underway

now innovative ADC time market the advance Our pipeline ADC pillar measured in Several in pipeline be believe to years our utilizing assets are technologies of in strategic with many will of to the billions products third is for other technology tens We empower to approved development. vedotin our dollars. come. next-generation

will teams come fruition parallel, waves multiple our working at we that In are technologies time ADC points. new to on of varying believe

ADCs we’re Further employing and ADCs expect out, cytotoxic example, of we drug new that immunostimulatory and utilize For mechanisms conjugate auristatin camptothecin novel action. technologies developing incorporate diverse technologies employ payloads. that novel well as ADCs to as other

our invest supplementing external reach continue position also in technology approved number to in have of the remain complementary that expand patients. and pipeline retain in We and could opportunistic potential. leadership to selective We our to still with cutting-edge ADCs assets more exciting order

and Roger our call development away, Todd the on turn and that, pipeline. detail commercial discuss who activities Take update performance. our Chip. provide With will After will to results our over XXXX will Then clinical an it that, I’ll financial Chip, guidance.

Chip Romp

Thank you, David.

to strong another underscores delivered close our for team strong commercial very a Performance commercial Seagen. across The out in year quarter successful execution QX portfolio.

frontline a share point in growth fourth and fourth reflects frontline is gross pathways gains in over gains in of share increase the resulted quarter Hodgkin sales were the the million, record setting. quarter guidelines, now XXXX. $XXX a ADCETRIS diagnosis pre-COVID a in incremental lymphoma. return nets Year-over-year positive rates, category X favorable which a XX% preferred to ADCETRIS NCCN and has in treatment changes agent to

to the frontline gains We and of HL are in with continue pleased opportunities incremental see ADCETRIS, share performance in for XXXX. we

patient fourth quarter of were of trial maintenance was second-line PADCEV second-line orders year. into continued of primarily sales PADCEV of driven included as Underlying by therapy. increase the for to million, the standard U.S. the $XXX due care use a clinical quarter supply inhibitors million remains checkpoint These the $X a in frontline growth last flow same setting. setting over XX% sales quarter.

teams commercial frontline launch metastatic in our preparing for with patients. into the combination cisplatin-ineligible in are a KEYTRUDA Meanwhile, setting potential

addressable As for combination frontline drug-treated are a reminder, in the option opportunity U.S. an total metastatic with represent new If would treatment patients the frontline setting. patients ineligible the this PADCEV Around setting approved, in the is XX% additional XX,XXX approximately a are cisplatin-based chemotherapy. these in sizable of and important XX,XXX approximately

TUKYSA. year-over-year. were to million, on $XX sales Fourth X% Moving down quarter

TUKYSA line patients competitive to continues plus market as a We despite treatment increased position well, the active the brain perform with plus HERX’s metastases. second-line have for TUKYSA’s headwinds in use especially those setting. second setting, option established in to related an ongoing for valuable

stabilization into and extended duration which flow third We the benefit of the line its of performance expect of patient from see third year. half tolerability. year approximately this a patients, to a second longer of treatment continues TUKYSA’s in or underscores to efficacy in

commercial now represents this HERX-positive in cancer. second FDA patients setting line metastatic month’s last After with plus colorectal in TUKYSA team accelerated setting. the approval, therapy approved This HERX-directed has first our launched the in

offer medical Although therapies a a limited population colorectal patients, typically existing unmet as modestly represents sized XXX rates. approved need, approximately high market of this cancer response

expression. colorectal of estimate cancer patients we HERX are currently addition, In for half screened approximately

commercial will be on our rates. patient efforts of increasing focus A screening

following activities Looking and progressing in U.S., planned we fourth the TUKYSA to look negotiations, reimbursement launches year. the in multiple Merck access intended coming and this launched to expand pricing have in Italy months. Norway the submissions TUKYSA’s territory and and is reach beyond successful regulatory their expanding in quarter, forward

third penetration TIVDAK an X% sales this ensuring Genmab The experiences treatment commercial increase remain finally, focused on of the important for XXXX. quarter treatment and of driving quarter, further were teams option. of million from $XX market positive and fourth Seagen the And

and innovaTV potentially OS look could the serving as outcome later an if which to forward submissions. it global also of trial result the X Phase the full other demonstrates XXX while basis endpoints, year, approval FDA benefit global in this for We

to pass discuss outlook the will who including XXXX. for Todd With that, our performance, Todd? I’ll our financial call over

Todd Simpson

Great. everyone us the for call. on Chip, Thanks, thanks and joining to

quarter I’ll across XXXX fourth full past for launch record from performance sales for of XX% quarter million well and $XXX and respectively. TIVDAK. year. contributions XX%, as billion Our This of was and financial primarily in XX% reflecting summarize our results and $X.X fourth XX%, business year the of reflect $XXX growth financial $X.XX in year-over-year were driven the XXXX respectively. as discuss and the included growth PADCEV the representing significant in in This progress and million billion product revenues year-over-year made the of the Today, guidance. Total then full year, the net by ADCETRIS XXXX, our growth

$XXX its and of increased by quarter for fourth and the Takeda the with X% in XXXX, partners, year million over million $XX by were year our sales ADCETRIS Full XXXX. performance Roche sales with commercial its revenues Polivy. full royalty revenues of Royalty in notably driven strong

Collaboration the revenues sales with Zai quarter. $XX in of PADCEV Lab million in collaboration the XXXX. in other collaboration a were well in These fourth quarter included year royalties revenues, as by third as new on territory Astellas $XX full and its million for including the

sales our owed Genmab million costs the each share well four for royalties of quarter full cost Astellas amounts partners, of of TUKYSA. was Cost include million fourth technology as the as of noncash These $XXX acquired our XXXX. profit sales for amortization year and and in and collaboration product brands, in to $XXX for

the in million $XXX our to the in and reflect year of billion our full continued pipeline were investment approved programs. the expenses These quarter and advance potential to expand for fourth XXXX. $X.XX R&D products

fourth full well was million This XXXX. activities corporate $XXX other year our commercialization in in the were U.S. ongoing in expenses efforts driven to business. the Europe growing quarter as million the support and for SG&A and by as $XXX

our to Next, turn I will financial outlook.

in total X% XXXX. $X.XX to the to billion, of representing range XXXX in XX% $X.XX We to of growth be revenues over expect billion

and commercial the This approved this now expanding increasing year, indications geographies. of we number and portfolio our four Beginning reflects are portfolio level. a guidance expansion providing products, to at sales product of

report looking the we of across results $X.XXX of that brand billion quarterly over guiding an mind, XX% $X.X are increase We With sales to to in XX% will XXXX. at billion, continue to level. a to portfolio, representing product

time. in growth most ADCETRIS for by ADCETRIS reach X to its notably and expect first territories expect lymphoma, across be in our this Hodgkin status We indications, blockbuster to continued use we year the frontline driven

is for Company. PADCEV established the an important brand and

Our contributions the expansion date guidance potential label U.S. has a April today XXst. PADCEV from for does not PDUFA which include of action

at into the indicator each our to PADCEV, XXXX. going of our largest will we perform And contributors brands We of half good expect will as second that XXXX. remain ADCETRIS a sales the of and how look in XXXX,

As growth are seen the quarters lowest of year. throughout typically the a first the sales reminder, quarter with

excited about cancer patients. into colorectal recent label are TUKYSA We metastatic expansion for the

breast While a the modest label represents expansion takes commercial cancer, us opportunity. beyond relatively it

expect overall colorectal HERX in an perspective, the from growth cancer, impact headwinds from that cancer From brand we in continued contributions near term, while and we and expect also XXXX. will in breast overall

our and while solid in efforts an future factor option later. update its trial through other look current to in with basket TIVDAK TIVDAK tumors, we indication, cancer, will cervical development efforts has which treatment we to a continue And growth finally, our provide important for for expressing for drive women advanced continue growth opportunities Roger become tissue

from $XXX to in Roche. contributions expect million, reflecting we range of be of Polivy its to $XXX by territory Takeda primarily sales million the with royalty Next, revenues sales by along ADCETRIS in of

rate As each the at year. Takeda of beginning reset a reminder, royalty tiers the

expect $XX collaboration which we the as from in range to to well partners. from $XX revenues million Astellas PADCEV earned includes Finally, be royalties collaboration our as other of amounts million,

are trials billion. $X.XXX our further in earlier and reflects to commercial This expenses investment innovation. advance of ADC to agents clinical expected our $X.XXX expand brands, to in stage R&D our the drive billion be range continued

million, in to to expenses drive to commercial focused products strategy. to range our $XXX execution $XXX growth be the million overall SG&A our growth approved support are expected of and of on

by XXXX product to sales is sales be of driven higher to share million over of Growth be to range million. Cost increased profit collaborators. will in and payments expected the $XXX our $XXX

to million to of expected majority of in Noncash million, $XXX is stock-based are the expenses be range $XXX the which compensation.

of strategy approved to Taken a our brands together, the our support growing reflects growth our financial fund guidance pipeline. and of the current development

of development Now, over for overview Roger? an the to projects. I’ll research call and Roger turn our

Roger Dansey

everyone. you, afternoon, Thank Todd, and good

the will of important clinical in our ADCETRIS, Since care share our updates to CDXX-expressing we lymphomas. medicines which achieved for foundation our I number happy begin have recent development is and both I’m a approved pipeline. call, last milestones. of

based survival potential the ADCETRIS untreated label. Hodgkin a adults NCCN ECHELON-X option preferred September, X from These In for in X data are treatment review the guidelines lymphoma, FDA updated, on or inclusion currently stage the to trial. X elevating the the with overall combination data were for previously under category by impressive

previously two was In study. with for on November, combination by and chemotherapy, Hodgkin untreated lymphoma FDA Group years classical approved high-risk ADCETRIS based standard in the the patients pediatric Oncology older with Children’s

solid We continue this first to the to expect which evaluate in other potential of the data indications for ADCETRIS, latter including half report DLBCL tumors, and we of year.

Moving PADCEV. K Cohort date upon a for XX, PDUFA with XXXX BLA of primarily has to based been priority trial. supplemental our April PADCEV review granted the from on data EV-XXX of

urothelial patients the PADCEV study KEYTRUDA As of or a advanced and cohort efficacy locally with reminder, this metastatic frontline in in cisplatin-ineligible safety combination cancer. unresectable, with

different presented. of KEYTRUDA the EV-XXX data in the patient amongst those of populations, and PADCEV of levels yet median GU, response XX duration week of This At of patient therapy that combination of XX.X%, showed not of subgroups cycles Cohort PADCEV ESMO, been These be and including generated we ASCO at across months reached. and has expression. confirm PD-LX the with K ORR consistent low presented response data analyses evaluating metastases in liver the that benefit treated will median key combination a

evaluating treatment PFS global note, continues Of be in enroll. line frontline study combination both, by and KEYTRUDA of the end. and a we enrollment submissions cis-ineligible Asia PADCEV in in in for the to U.S. trial around including available is study China EV-XXX and completed and a confirmatory EV-XXX and in An in November intended the population is with This to PADCEV top Cohort XXXX Europe support EV-XXX cis-eligible K. estimate a K of was global world, to which broader is of potential extension year’s accelerated in data is enrolled patients, approval setting. Cohort

we is continue the year. earliest may perioperatively. a which Phase bladder presented bladder two X PADCEV Initial advance with stage, non-muscle earlier disease, evaluating which Phase combination disease invasive metastatic therapy. conducting studies is the are as be EV-XXX given muscle data PADCEV X global with this a study, than In invasive intravesicular cancer, In ongoing to given KEYTRUDA stage with cancer, we later

other with PADCEV’s are cancer, Astellas, expressing be in in solid we’ll the Beyond urothelial together potential we Nectin-X considering year. first of tumors also half and initial data sharing this

previously with for adult of colorectal with patients metastatic trastuzumab Continuing cancer. with treated recently TUKYSA, combination in accelerated treatment received approval we the

outlined for situations ineligible guidelines chemotherapy, beyond NCCN chemotherapy. where been States are received frontline adjuvant include wild-type trial treatment United a A cancer. second treatment line a is who’ve the global for RAS colorectal CAPOX for metastatic for FOLFOX Importantly, metastatic the been intended with first-line option guidelines option intensive submissions. XX have HERX-expressing confirmatory include progress as within the disease Clinical patients for option treatment option on a cancer, in in to as to a trial and and updated primary TUKYSA last patients has months, support frontline who or treatment colorectal which patients metastatic initiated serve Phase and X in any patients

in TUKYSA patients line in our in completed breast XXXX, June in to and of study of this second-line year. cancer. plus enrollment HERXCLIMB-XX, combination with the X Moving Phase metastatic first data of Kadcyla is half anticipated top

metastatic option option, an plus important of Kadcyla patients the breast with And line treatment late Kadcyla cancer. combination patients alternative is metastases. the could trial is TUKYSA with brain provide HERX-positive for if for an successful, including

HERX treated previously to Kadcyla, first for year combination focus basket present our with this data with half from tract with a cancers. we on in metastatic plan biliary solid of in the alterations, in Additionally, tumors trastuzumab trial

the the to States patients cervical data approved for the with chemotherapy. of cervical metastatic with States trial cancer global line the now United cancer disease study in is which trial in regulatory in progression the the year. recurrent in second half Phase is confirmatory after to for TIVDAK, support intended this is or or global completing on close turn to This to United treatment as top X serve and enrollment The potential I’ll with of innovaTV-XXX applications.

cancer be continue with we Phase an data Initial is in cervical Beyond dosing the TIVDAK projected neck malignancies head potential to for in ongoing cancer, through to X year. innovaTV-XXX. and study, schedule modified other a presented this study

disitamab in evaluated combination is this urothelial for DV, to metastatic KEYTRUDA KEYTRUDA X and cancer with with treatment HERX-expressing being metastatic as initiate vedotin in urothelial HERX-directed Continuing Phase We a in frontline monotherapy cancer ADC in this year. later with or plan the of tumors. combination trial

Additionally, or gastric combination HERX DV breast KEYTRUDA TUKYSA a cancer metastatic in underway cancer. are activities development as to low with HERX evaluate and and monotherapy expressing in

our X at to targeting a starting wholly early-stage integrin data Moving beta-X. Phase We clinical pipeline, vedotin with owned in reported ADC SGN-BXA, November SITC.

addition at head antitumor cell tolerable with in In manageable tumors dose advanced solid and profile pretreated in cohorts the cancer. appears regimens, has non-small safety to activity encouraging lung patients and neck expansion triggered cancer, and a explored initial observed and the esophageal heavily cancer

lung durability response year. response data, later on clinical rate. including cancer confirmed of initial Focusing be will XX% the objective reported a observed we subset, Updated this

ADC SGN-BXHXV, this with to immune a novel the now potential opportunities Turning in breast, endometrial targeting cancer. BXHX and ovarian is checkpoint vedotin

this clinical trial first-in-human year. progress making data initial anticipate the and sharing are in We

partnership and IND upcoming additional are we at with drug CEACAMX Further, therapies We planning continue XXXX ADC submission novel are supporting planning to an payloads. IND other engine with to ADCs with we medical In a IND with data and the for submission meeting. ADCs cancer. for utilizing Sanofi, our presented targeted be linkers preclinical advance submissions targeted

in focused T-cells and metastatic for Phase recently SGN-BBXXX, a preclinical enrolled submission melanoma. IND positive patient cells track first initially refractory gamma trial or achieved a has on targeting X relapsed SGN-EGFRdX, a bispecific XXXX. in costimulatory tumor first-in-human bispecific EGFR is on an delta

data look assets. Seagen with our regulatory milestones encompassing pipeline Over emerged achieving as forward and multiple to important this the we a portfolio has our the course approved of year, from now and manufacture we to into company. and and passion work impact a discover, commercialize that a to develop, leading medicine as position lives. capabilities strength We transformative of oncology Seagen build global company operate expertise,

ask that on to opportunity increase now will to And today’s that ask to limit turn participating yourself Operator? Q&A. one chances call to we questions, the those have you question an We please each.

Operator

Instructions] this [Operator begin gentlemen, from and Ladies session. our comes question Salveen first time, from we’ll Goldman Richter question-and-answer the today at Sachs. And

Salveen Richter

the in one, the the likelihood non-muscle to of drug would that’s And and type? about in will us, the cancer then you us when be working reading the rationale bladder in be first cancer tumor And think then, as data this bladder metastatic invasive PADCEV two, the remind just working With this be for half, what can the positive? invasive bar data set bladder mechanistic presented? out muscle understand help we for

David Epstein

it’s Salveen, Hey great question. the for Thanks David.

about of the in building you As lines increasingly excited franchise bladder know, move we’re with PADCEV to we’re earlier pretty strategy the to therapy. is cancer and

in We’re bladder eventually DV going build also cancer to introducing that directed HERX-positive to further patients. presence but bladder cancer upon by

you’re to our cancer are non-muscle and on think bladder bigger both, where much right the is. those muscle than because I invasive so approval current markets focus

think I you it some share insights program. Roger, that would best be could on if Hey

Roger Dansey

Thank David. you. Sure, problem. No

following Firstly, speaking, of profile be an Nectin-X the it’s the all of And frankly states. excellent stable the across is given So, great PADCEV profile -- one bladder disease potential into expressed the for a question. could Salveen, the reasons:

patient population So we would as we very have superficial as much this cancer early disease. have bladder expression in metastatic in Nectin-X

data Secondly, formulation the in and some into when course, this we share are pre-clinically preclinical but able, both we had of its when saw clinically no systemic we instill PADCEV we current exposure. we’ll bladder,

look PADCEV of with profile, more systemic the bit a and favorable may the than profile tolerability administration. potentially little So safety

Secondly, that PADCEV and direct fact, by the contact impact tumor into sort bladder of the in an in orthotopic giving cancer in an effect. model we with could, have bladder showed antitumor we

think I we’re optimistic. So,

have, year. obviously, And sharing later opportunity. information such in we’ll the about as actually we excited be We’re the that

which BCG-unresponsive the where begin, almost with a place everyone in population. starting does is are We

folks are fail So, standard therapy. who these

what in the guidance terms a path frankly, that we’re like, But some population. could for that disease. look for a response things with do path type registration defined population the rates and of type been forward that exploratory well what we of In drugs to has a look like? endpoints, BCG-unresponsive this phase. FDA like as CIS regard the is there complete already I could think with what hurdle And are there other still space. for can -- see broader developed we But as being in see are

Operator

Next question comes from Matthew Stanley. Harrison from Morgan

Matthew Harrison

think guidance was you K, maybe factors year? just of just Cohort approval know any you I from this I ramp setting? receive if impact influence could in but the wondering, the second obviously, the Thanks. was how potential I in some that you on doesn’t half are trajectory to think provide commentary And wondering could about you the accelerated that include broader if

David Epstein

Hey likely is meaningful and well. Matthew, XXXX. guidance be the say does for once thanks the incremental I for mentioning see think course update the review I want we that not be going it’s of the just label, to sales during people. able the pretty our we terms to And Cohort guidance And in will year. to K of have we include

going turn now. I’m to Chip it to over think I

to If think into the because see uptake on specifics, any too lot without going of we’re we that you color can until a I give final much label. hold going

Chip Romp

Yes, sure. Thanks, David.

comments. would couple I of So just a add

In care. marketplace. PADCEV standard this is now second-line in setting presence established an the the have of We

of good frontline to insight label The into market have capability space this have. setting. the So we the substantially continuing grow and the the that than is current itself into larger have we brand

fact, the numbers, cisplatin-ineligible. look to commercial would In which by half of we about about we with of treated it’s largest those, drug it label And have, label would XX,XXX if it you date. probably about similar would are have be patients that and at XX,XXX those the

this opportunity meaningful a the teams. for so, is And real

Operator

Morgan. from question next from comes Our Jessica JP Fye

Jessica Fye

for product you you For that see PADCEV, much opportunity? embedding late you’re the I’m guess Recognize the about the indications? obviously talk this fully growth in existing close year. penetrating can But ultimately are growth line U.S. talking in approved you the about remaining how how to I

David Epstein

Jess. Thanks,

grow opportunities brand therapy. albeit existing in the big are slower continue be indications, going moving up into The of earlier rate. So, the will to a at lines to

Operator

question from comes Jay Oppenheimer. next Olson Our from

Jay Olson

HERX-positive especially gears breast how Can differentiate And Maybe latest on thoughts then also to DV any with the to I’ll you about shift well? also, over from And expect in your regards landscape? you. TUKYSA HERX do cancer. the to just landscape competitive terms perspective of you as talk maybe competitive HERX? Thank on

David Epstein

Jay, Hey David. it’s

drugs bring that People some market things And Clearly, into up to better on perhaps the give get marketplace. to pretty a has would color, right Chip that still to very that. additional ask breast they to shaken responses drug Roger good I’ll think So I’m and then even it seem add going HERX, durable is The a bit. medicine. or is center causes developers in to introductory dynamic which of carefully drug, now. how introduction about

and the lines a as we come is of there’s very course DV, that some good go more, will you in treatment. thinking, of initial my breast add and multiple patients a payload And through HERX, drug. because different case behind in know, cancer to therapy largely In have Roger during opportunity the an of will their

In containing combining then TUKYSA which where that underway as the trial Kadcyla our patients perhaps metastases, regimen. with small combine population will in the differentiated is there Kadcyla, double with we drugs, the future, report TUKYSA with with we’ll Kadcyla. of as not-too-distant size and eligible expand, brain the roughly in that out for patient a case good data strategy molecule a would we’re know, of you have be TUKYSA TUKYSA, other benefit really to,

of moment, to patients. TUKYSA clinical of of It’s about can color. doctor think you combination used Kadcyla a mets as Roger, from that just and you add markets at that. but anything chat want the difficult it the about one set do forecast to more that drug, being treat to really entire use more now a some for But standpoint? If we some visceral you a brain gives mets a currently

Roger Dansey

I making we HERX defined, sort cancer drug, again, of is actually excited defined opportunity. population would I of having not a us, a population great defined ahead is statements David, your is think, about previously see an that DV. just and with difference. in breast it’s And It’s which that agreeing we’re And add, population. HERX-low a a

point gone think have to another, payloads. patients different sort a see accepting ADC And with physicians could patients we antibody. out, chemotherapy-based a you go therapy, of don’t from Once that type of and to different difficulty I any as they have there we one are

Ours a directed against proprietary is not trastuzumab. HERX. antibody It’s

context So, development KEYTRUDA of outcome. that in like believe believe also where we’re may a hallmarks we we point combination, see -- pretty And impactful those the would still you working up, perhaps the vedotin-based that strongly, on PD-X of ADC inhibitor, potentially with leg as I plans. a our can of data is has this a one and PADCEV we immunotherapy have an an really out

we And so, as And a well. think about mentioned, as combining any possibility tucatinib with inhibitor. we development you plans about of have think we the DV, PD-X for

our And so also combining in plans. those assets

Operator

next Steven comes Willey from question Our from Stifel.

Steven Willey

first the know talking I in BXA, of half on to just an you’re guess that update this year. I

that expansion head with responses kind But you extent Thanks. that you’ve dosing along you’re does of that emphasizing should for schedule And to additional dose into dose dose expansion think to inform date. observed of data neck want update? in lung? forward and selected what expect have we I durability the take the any been that to

David Epstein

answer ask let to your and question. start, and up specifically Roger follow I’ll me then Stephen, So, more

ADCs. Let have say, me in of experience this just company with lot a vedotin we

not dosing let we me say, but It’s see to And across to when good where different full read is So, shaping asset have become up proof, a product we pretty pretty likely in good go. is this a for our early read. on disease, cohorts company. a BXA transformative the just data

We’re be it. this will be There about more any we’ll Roger, which thoughts? data later sharing. very cuts excited year,

Roger Dansey

will you we’ll But disease. I say the until So, on great general it’s that present. schedule details what we the question. in hold a get obviously, regardless of And think is would one dosing land I we

we sharing one an data to as cohort said, terms us from potential cuts other year in expansion well. or look land for as the to the dosing consider cross forward further trying is of information the to coordinated we So And to and what on information of a data the durability schedule. optimized event David flow be there’s in

Operator

comes next from of Geoff Our from Meacham America. Bank question

Unidentified Analyst

calling Good Meacham. you is Thank in question. the afternoon. Hao This [ph] for Geoff for

So, I ADCETRIS. my to question think related is

strong quarter. very a again, So

cited you penetration, think there. and momentum about I price, the COVID

sense Do how Just -- XXXX? XXXX? see wanted see get a that to this to of you sort trend does you continue in about in

David Epstein

and they for mentioned will start and we product Let new period say, blockbuster time. which territories, guidelines, acceleration of Typically, in new because maintain a me in commentary, is become the to that Canada. Todd’s that our U.S. this labels of just when brands accelerate a

strong be for ‘XX thinking year about our So, another the will brand.

Operator

from comes Gregory question next Our Capital Renza Markets. RBC from

Gregory Renza

on thoughts profitability. request and your for question Great. progress David for Thank on to far. much quarter you a a very question. the team, taking renewed the and maybe And so really congrats the and path just

you’re as Thanks certainly pipeline think to that these curious a profitability? how and success pertains high a relates to doubling you that you much. to ramp better or probability early it looking the at believe just Just prioritized programs the have on committing so of down you probability programs at the that investments about as there portfolio, as it commercial have looking

David Epstein

Yes.

you, Todd meeting near each and globally highlighting we’re So, in the JPMorgan can follow the I into that’s, just then in of first epi and terms global a line than call a And owned or in it, mean, assets, cancer cell the non-small that market. blockbuster. bladder up. BXA will for PADCEV times be answer healthcare of meeting, is this X for context is the I’ll call, lung market which short cancer to conference three size start put

we’re So, company. about talking tremendous opportunities for our really

going balance but sheet you’d to is become I about substantial. in want would we it’s way be is add, we do not think when Todd? is matter, the the minor to suspect how very having really necessary profits these So, breadth first trials out they Anything to priority terms thoughtful get be upsides. spend invest eking cash, of our huge profitability, And the would profits capture pivotal those strong. Obviously, would our things of adequately we’re I that about to

Todd Simpson

the for Thanks, thing. Greg, Maybe just question. one

question, a we long you a If -- first good time, for gotten out. it’s is and this all one question a it’s we’ve steer that

even the I up investing and K, excluding our up the think more total to to ‘XX and year. were meaningful bring drugs $X.XX year’s think our about you revenues portfolio about. XX%, patients XX% our at quarter if brings in continues our this to strategy When just -- about we I revenues Cohort last at we’re billion guide, and look to be platforms our need. the for And in just you print, look

has So illustration I the how successful think think an of strategy been. we that’s

investing pipeline an With that in. got broad we’ve amazingly continue in deep and to mind,

You solid call and their all are and about that on little wholly are tumor today and the populations a Seagen. for DV and drugs address BXHX. assets programs like meaningful heard BXA purposes These intents owned bit by that

the lot invest types to in of invest success So, the in had we’ve the drive assets that today. and heavily to sense a to for we are and of think those growth that really make us continue

David Epstein

just future, are to to, if exciting told think was profitable we add Todd get pretty off is would be think could we you wanted more way, what we another just cutting than I in soon which I much our we but where to that today.

Todd Simpson

Agree.

Operator

Schmidt next from Securities. Our from comes question Michael Guggenheim

Yige Guo

PADCEV. for taking on One question is for on questions. Yige This our Thanks Michael.

with K. approval, treatment duration as cycles medium we for clinical first-line Is You combo the on April? PADCEV follow-up this were roughly that And KEYTRUDA still patients in cutoff? date still could by number cis-ineligible XX the PADCEV assumption modeling previously practice change Cohort Thank a reported one-third treatment in PDUFA duration as patients still how for of good post data last longer in in you. the of nearing are there

David Epstein

Yes.

are part little see part is given say think in thinking about therapy. we to is patients I’m to April on less, this in you because more density setting we will between add? is might second-line patients how and we front-line a give therapy to excited the the patients PDUFA One all ask on long any be be setting anti-PDX. FDA told to should decision to drug the that Chip, probably healthier, bit with very they these dose date. better than Chip and in KEYTRUDA, vedotin bit of generally the when about So, a do that going the combined want synergies would in are you with little because longer thinking you’d try upcoming this thing I

Chip Romp

Sure, Yes. David.

we note label have a it’s yet. just to think I important don’t

duration details we certain could So would going change. that have is in our somewhere X longer months. second this to closer in trial The duration experience regard to do with But clinical on see is think frontline, we the line. a general thinking what than to we to we expect be

As a on David patients speaking, a less dose monthly and basis, a fitter. generally are mentioned, a bit little dense it’s regimen little the bit of also

we kind of what So, that’s we’re towards. looking think

Operator

comes next William question Our from Blair. from Andy Hsieh

Andy Hsieh

David, you. congrats. Great to hear from

I second or I’m you So, let’s third is of of accelerated characteristics the or curious, to the and the as UC? it receive PADCEV broad FDA approval? [ph] clinical in front-line a the the realm underlying as versus, about the say, possibility review label curious biology enroll line EV-XXX am patients initial just just beyond first-line in cisplatin-ineligible

David Epstein

going I’m So, this to Roger. to put one

just Let complement. -- you a me gave opening nice there, say me

I’m Let in happy this right on heard in the company, me that you months even the some I’m of now, call. say I’m bullish three about to that just really be future and at of more Seagen.

growth, asked IND payload. in-line a leading is haven’t campto that’s the in getting ready strong bladder be have been a transformative shaping to team discovery we to position this file BXA cancer. up have asset, And we We yet, although with year

is really company this So, on the move.

do question, Roger, you specific Now think? for what your

Roger Dansey

an It’s thanks. interesting Andy, question. Hey

what -- we we view our is hope think for. get we get I ask we essentially,

the As will cis-ineligible population characteristics the line we on said, defined as the And top David like is end right behind year, and we is of EV-XXX, may in signaled have, year renal well. things based towards -- this of we’ve perhaps. sometime The dysfunction which it, going data review loss. well hearing have

likely would successful, would unlikely. which think I the the it label cis-ineligible fantastic, is although I be if be we’re My it So is personal the is will studied, outcome view we population think patients. reflect very

Operator

Our question Joe from Sandler. comes from next Piper Catanzaro

Joe Catanzaro

Hey my progress. Thanks for the on congrats taking And question. guys.

that visibility potential impact usage think in may So the had the just now EV-XXX. the how wondering that control complete, the I of any study. in Roger, maintenance enrollment into was arm extent mentioned if performance how arm you control you With avelumab and you of about

David Epstein

Roger?

Roger Dansey

Sure. the for Yes, Thanks, Joe, question.

meaningful you its we care recall, the to with were response just or as complete patients obviously have And went a frontline give history, of bit part partial EV-XXX. response, out if through process So you little disease, have response a provided of either rolling is disease approval avelumab they -- it control. disease control, of

EV-XXX. trial. they that a so what I avelumab used. we’re And with the be. population It on can’t to relatively population share gets will looking actually at be will that global the is you restricted level Nonetheless, compared that

has that be then consider EV-XXX happen. used, will arm the likely if avelumab So, that conducted on been around should the world. well control And physicians

use, more can I I detail say give you just how can’t any So there to much. avelumab is as

repeat KEYTRUDA. includes value a of all in a the itself the demonstrate what to the degree avelumab outcome I I of in give regard obviously, PADCEV optimism progression-free optimistic. survival and generally an with that things there as overall a type K broad in as again, survival patients. have With trial -- cis-ineligible which A I populations from we we’re done global curves like Cohort use, and context would the of mean, form will two are -- remind the and and that done is there generated end different although through they’ve perhaps experiments, if outcome, patients and And these survival us are than the have well mean, Cohort confidence terms of trial, that of cisplatin-eligible the single-arm you, not we have we experiments older we of of population in

have positive the about outcome. excited Until results think of We’re the will the good trial But tell out, combination. you can’t I I reads we the a shot what be.

Operator

Securities. from Berens comes next Our SVB Andrew from question

Andrew Berens

presentation to first-line able just the seeing of usage following get for but not label, you’re some wondering until a I’m promote if you’re know you set. PADCEV I data the already

just suggest -- could doc it some ADC you Some line Wondering if was and first wondering checks already. us in the could give developing at? if then, if under already you technologies. an you you’re they’re what us idea of see our peak you let And that the looking covers of I using mentioned novel can

David Epstein

setting? bladder any ask be sense cancer Chip of just the first-line in PADCEV whether already not first, used So, or I’ll may

Chip Romp

Yes.

a So be that, now. organic. that to It’s not much. but bit, would We little been obviously. right there’s don’t promote minimal But

David Epstein

And answers waves about -- discovery for bit say, one little we more talked away. At and payload our INDs. asked that indicated a already of today much JPMorgan, about purposely multiple we therapies campto-based give my are you technologies. then of hear we not filing I were, too efforts. would so to And superficial as earlier our first in to I

the very term. near So, that’s certainly be area in coming one will

believe we as be anything be as working linkers are that a seen well we’re now could that opportunities, and quite suitable just know, to quite we expertise current now of from Roger, have we far. There’s other a vedotin technology. the recently actually our clinic. the We for process particularly say through choosing targets into an of will many, heavy prioritize what on number different better so you’ve then, of payloads are and proprietary we get and will go little R&D further working on many I’ll And where think discovery assets, the focus. we’re There’s into going our them group. which as you the resources to up Head became we

Andrew Berens

again. it. congrats I appreciate And Great.

Todd Simpson

Andy. Thanks,

we have maybe I one-- Operator? one think for more question. time

Operator

Leone James. Raymond comes Dane question from next Our from

Dane Leone

it’s hurdle and tucatinib’s place expectation of on the study. PFS HERXCLIMB-XX, think if the the a readout your your And more brain question we address study, ultimately the your that mets I with actual to With interesting, is that trastuzumab me, come that regards primarily for people benefit amazing. this agents? of are or would intracranial of obviously in PFS well-controlled, broadly PFS in a is that to expect bigger you out signal team of statistically from will. for larger the signal tease it’s is could benefit from a progression of lot synergy what ability team looking that have One tucatinib the expectations And put two to a disease,

David Epstein

Hey Roger, to do want on start one? you that

Roger Dansey

question. Yes. interesting It’s an

sort design Just drug, to same HERXCLIMB. well-known or a for And importantly, the of elements remind obviously, for has scene said, David mets, you it used you with set second-line essential allow the in on patients criteria eligibility plus, is as either brain on as the population, as focusing HERXCLIMB-XX, Kadcyla is it with did disease. and and metastatic we controlled But or HERXCLIMB, active. this

And so, HERXCLIMB, patients did HERXCLIMB. obviously, in expect in meaningful as as did we with we number to of a -- HERXCLIMB-XX brain have metastases we in in

this you simple just around treatment again design. assumptions add-on to is to regard a design, the of remind effect, With

of the Kadcyla. this So, to tucatinib is addition

I assumptions. accrues, are all tucatinib for will of share the pretty But looking be specific of benefits any so, above. you evident. we with can’t think, And I

see in add You of potential broad we tucatinib population? effects decision for subset with treatment the Are we Kadcyla tucatinib I the we combination. a for yes. all able are for make positive metastases? results for looking of to mentioned, if if and think treatment that answer patients instead of physicians, is are being looking a to be an in trial and will decision meaningful, brain the part physicians the And plan a is to meaningful effects is Yes. The treatment patients

David Epstein

Great.

So thanks, Roger.

many you just to this paying and you’re close I’m conclude call. is by data be thrilled very milestones. exciting us, here, me for and With that, regulatory we’ll attention the all thank the I for be to a year going Let saying our company. to

Operator

with gentlemen, and joining. Ladies conclude today’s We and for presentation. thank you do we’ll conference that, call

disconnect your now may You lines.

Seagen (SGEN) 15 Feb 232022 Q4 Earnings call transcript