SGEN - Earnings call transcript Q3 2021

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Operator

Good afternoon, and welcome to the Seagen Third Quarter 2021 financial results conference call. All participants will be in listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. is event this note being recorded. Please now Peggy Pinkston, would like Relations. to to over conference the Vice turn I President Investor of Please go ahead.

Peggy Pinkston

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

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

Clay Siegall

expanded welcome Peg. third Good medicines. forward quarter on approximately our afternoon, third year-to-date you, clinical Thank and commercial, approved million everybody. achievements. to our of And across We product We net regulatory, to updates of quarter, look reported call. $X for and portfolio reflecting recent today sales the for billion $XXX the providing growth

sales, strength to continue demonstrate collaborations. royalties robust We by fueled strategic financial product and multiple

Our through strong us that internally our about advance shortly. and you balance hear external both business to sheet pipeline will more expand and development efforts allows

approved are September, disease women marks its we and on after or patients only development, our Our TIVDAK progression fourth commercial cervical through clinical or or cancer metastatic approval an Genmab. from than vedotin in expanded granted our co-developing the which a FDA two team. factor less of years, first month, Upon recurrent portfolio conjugate, to the our products metastatic execution, global strategic strategic with for approval and We've with product first product, is became TIVDAK, to ADC important exceptional one achievement cervical drug commercial antibody FDA partner cancer. accelerated by partnerships. Last accelerated chemotherapy. a priority remarkable recurrent in Tisotumab potential our commercial with Seagen's or is is with maximize tissue and four for targeted which to TIVDAK milestone

We been are commercial on focused has and execution positive. early strong launch feedback

global future [Indiscernible] and program to support intended conducting potential Tivdak's We a are development also broad clinical expand

Operator

hold for Jackson? for Can have Josh The and I with? Operator. again. last Welcome the your is a first me to Please specialist. name? [Indiscernible]. hold conference Please Company This you're

Clay Siegall

USDA metastatic that cancers, broad in potential which potentially Phase HER-X HER-X enrollment X MOUNTAINEER has positive completed we [Indiscernible] positive Specific [Indiscernible] previously file tumor cancer, care in faster class. advanced cancer Broad Really. the valuation also registration to Standard in Quickly. HER-X accelerated -- and end, that development Bill amplify to includes colorectal program breast and recently approval in 's could support of [Indiscernible]. clinical cancer. treated.

As speaking and Europe, across indication, Americas. a second Asia-Pacific, adequately. the

dynamics, advanced positioned are this and Results support accelerated have We could approval [Indiscernible] the under cohort potentially of chemotherapy. pathway. we [Indiscernible] FDA's registration market

[Indiscernible] available. ADCETRIS' potential sales quarterly commercially Ram is record [Indiscernible] with to [Indiscernible] s to performance patients. maintained maximize Lastly, benefit solid

tumors broad global global metastatic TV [Indiscernible] elements monotherapy important Biologics active an expressing solid territory [Indiscernible] of and as third-line lines or cancer. is help in deal License TV harnesses second a We for it supplemental TV technology, Our second ADC potential to for differentiated Asia, strategic ADC combination asset. strategic a the as a outside accepted reach. 's development and detail. expanded will priority as go TV's has Administration being Japan is expertise, our received at for Tisotumab further REMAGEN excluding and novel Singapore. with Products represents Medical Roger and that Application believe experience a National conditional and of urothelial with fit gastric agreement vedotin strong of our range is The their advance infrastructure. of our into And later maximize to PD-X These value will approval developed and HERX already is cancer, China inhibitors. in across and

innovation, expand our -oncology through corporate immuno and Our partnerships. deep is pipeline priority strategic third developments, diverse strategic and early-stage agents, encompassing ADCs, to

further hematologic BXHX, and ADCs expected are advancing Across pipeline, our we that submitting malignancies, of solid including early tumors we're targeting and INDs a XX clinic pipeline. to range programs next in for Importantly, and novel the late-stage four at least early-stage programs additional PD-LX enter year. bolstering our including two are those

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

Todd Simpson

for the afternoon. on thanks and this call us Clay, joining to Thanks everyone

reflect discuss the in then Total our financial our Today the million across of $XXX quarter, significant for in year-to-date XXXX. made by Our for results the growth quarter, representing and for the third totaled the quarter in the summarize revenues product million third XXXX. in third year-to-date, outlook across results growth I'll This advances business. financial $X.XXX portfolio. were the quarter XX% sales of Product over billion driven third $XXX in our and year. was sales remainder last

in results for to interest included the trial, in this, pleased In our settings, see are we PADCEV million in growing another sales conducting, quarter. Company impact drugs wanted addition, of use highlight and the growth clinical $X quarter given third they the are combination for to PADCEV to sales that on combination our this

bringing year-to-date product sales royalties GSK. well Growth as increasing a third XXXX were were to was Collaboration launched our in by million of and for revenues $XX Polivy quarter BLENREP Royalty in in ADCETRIS and Takeda, in $XX over third the of on million revenues $XX the by as sales TIVDAK the million portfolio. reflected for late commercial higher XXXX. year-to-date by Roche XXXX. Lastly, $XXX quarter, the quarter, million fourth in and the

year-to-date our as the costs due regulatory Third XXXX, XXXX, $XXX for licensing well of the in as quarter REMAGEN for quarter the for year-to-date upfront of outlook of partners. our XXXX. each in royalties were million milestone the continued the product share expenses for third remainder support million quarter third of early expenses This Astellas, are amortization our included across technology were across under late-stage Cost the are of in quarter of U.S. with PADCEV launches GSK, launch gross increases $XXX achievement pipeline. the sales XXXX. product to and revenues with XXXX. cost our $XXX the one TIVDAK collaboration million updates in a for [Indiscernible], $XX and now as sales over to the of third $XXX recently, and $XXX the provide quarter to product million the in the for R&D third investments investment the increases TUKYSA collaboration of million I'll of ongoing as as million and and over was the XXXX, supply beginning million reflect to our reflecting sale of in expenses profit noncash brands, acquired included, for in These and year-to-date SG&A $XXX These financial Europe, and to more payment several sales. well ADC Takeda

of product million $XXX to $XXX more our ADCETRIS We expected $XXX range $XXX on million. range are XXXX be of the brands. in the of million, context now million provide million, X later. range are to sales million market Chip and in guidance $XXX PADCEV the TUKYSA of in dynamics to increasing $XXX to will for all sales

sales we for its million. to to guidance million, $XXX XX XXXX XXXX Takeda ADCETRIS of $XXX royalty in to by our are reflecting increasing our primarily guidance are We range to lastly, And of $XX of increasing a revenue range stronger collaboration a million revenues territory.

expenses, result the $XXX under Turning a of amount REMAGEN primarily we upfront the guidance to to $X.XX are R&D billion as $X.XX increasing to now due expense million collaboration.

And reflecting also made the remains expense to in quarter $XXX investments. of in sales This $XXX of billion [Indiscernible]. ended million. We guidance our cash lastly, and guidance $XXX cost we narrowing Non-cash increasing fourth to $XXX with payment guidance reflect to quarter. $X.X not range million, the of to We are SG&A are higher our REMAGEN $XXX primarily the sales unchanged. does a to billion

we're continue this Our and our pipeline investing and so financial the pleased us strength business, allows year. in far progress to with

to Chip Now the performance. I an our call turn overview commercial of will over for

Chip Romp

portfolio PADCEV, Performance or ADCETRIS approval XXXX. of And $XXX a in launch we million, strong pleased delivered commercial quarter and increase the QX with quarter. was over Todd. across TUKYSA, you ADCETRIS, in XX% growth the product. all fourth Thank third are TIVDAK, the were QX. sales and

best data We X diligently or And solidify gets the the data anniversary to physicians lymphoma. commercial are marked ADCETRIS regimen the the product survival Hodgkin to and XX-year Stage and of would frontline to in to patients meaningful this ensure worked ECHELON-X approval. progression-free teams to August continue patients. thank dedicated frontline X landmark option on the for as important focus These like patients. ADCETRIS appropriate I the X-year that

of PADCEV. more to PADCEV, over patients of Position representing [Indiscernible] Kaiser, uptake. generated for indication to over XXXX. $XX checkpoint to adoption million, promoting TUKYSA a mets, pleased quarter with survival million, addressable for benefit continues and clinical is patients third brain and were with that our with the be the post-platinum this additional guidelines, to U.S. the see and maintenance increase to countries. to XX% the platinum-containing favorable quarter of for U.S. who are lines in third reimbursement quarter the were with quarter utilized for continue continue inhibitors patients on in uptake XXXX. later increase demonstrated quarter chemotherapy has Moving consecutive third in us In sales trial, along seek also In third we confidence and from XXX% We're Transitioning Europe, incremental sales Xth This most increase, gives sequential $XX second contributions ineligible growth, additional from marks the product HERXCLIMB overall we as European Europe.

Finally, from excited launched, oncologists were to our pleased look and we and work Genmab. reaction has TIVDAK early that we partner continuing with we're closely to with forward

our are We setting. navigate in Seagen new patients third TIVDAK and help eye support requirements. Secure, utilizing important care line TIVDAK's program, the medicine provides second well-established for an to

launch. we offered get Our providing and objective I response previous to typically look forward more as the rates poor options outcomes. on details further into have TIVDAK low

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

Roger Dansey

with Thank you, metastatic with in based approved to treatment trial approved progression applications. pipeline. the trial, Phase cervical or with Chip, regulatory is medicines enrolling for to everyone. global studies. a updates chemotherapy. is afternoon similar Approval upon disease the and on cancer, of the support full other U.S., was serve currently and well clinical global innovaTV begin a cancer as happy to our development which cervical intended in and XXX, I'll A supportive for recurrent from to our remarks recent as the TIVDAK, I'm patients population data is my innovative as share X after consumer-to-trial or adult good and

XX% median the with and confirmed trial bring is metastatic [Indiscernible] overall a recently in saving. of and XX% earlier the in into the goal for second months. of that and innovative to XX.X TIVDAK TIVDAK the and response In rate KEYTRUDA of next ESMO. the TIVDAK combination of complete an of response we presented recurrent first-line The XXX first combination second-line, DOR XXX of in data duration saving purpose, are the saving of X.X XX% months. resulted response resulted from for in the of and line cervical [Indiscernible] of Our Combination were or innovaTV conducting cancer, lines the

are inform TIVDAK cervical for based by cancer. a We approach these data, combination which will frontline encouraged

In landscape, the in addition, TIVDAK [Indiscernible] tested. the which combination KEYTRUDA need defines recent in accelerated to setting, first-line approval be further will

Turning malignancies, to in as evolving landscape, treatment now tumors. the Kaiser Kaiser to well KADCYLA NGI other alone setting. in in progress we cancer, braced metastatic line HERXCLIMB-XX solid second growth plus In III breast development he evaluation HERX Phase the our to versus is continue first program and KADCYLA trial as

TUKYSA study breast As a enrolling Alliance which HERX the to run similar KADCYLA completed enrollment to HERXCLIMB. we continues with KADCYLA is reminder, MOUNTAINEER, advanced results active the high-risk positive This by HER-X next them metastasis in enrollment In being mentioned, the colorectal trial accept in which cancer, this data evaluating cancer. is with assessing randomized with and Group. alone. adjuvant year, if patients patients compelling, is potentially brain for is Clay RD are MOUNTAINEER eligibilities as We TUKYSA versus support could COMPASS cancers, U.S.. GI In Cooperative and approval anticipate accelerated in treatment trial, as have the

evaluation chemotherapy our with with studies, for trial as well in as TUKYSA GI in cancers, PADCEV first-line basket (ph) tumors Additional in solid platinum-based alterations. HER-X combination

Finally, expect of a testing top-line is PADCEV, and I results breast will positive into are patients In we have This PADCEV on therapy. we trial of which for who is in of combination the EV lines as urothelial HER-X of setting, an within study to approval Cohort and support earlier in enrollment completed cancer. the in HER-X intended are KEYTRUDA now cancer. where combination we turn metastatic focused TUKYSA Cisplatin K, to remain first-line XXXX. we moving to for accelerated the treatment -XXX for for ineligible report conducting application U.S.,

PADCEV marketing bladder trial, as the well is Both we with and testing applications. to patients. X, combination [Indiscernible] into muscle EV Cisplatin compared KEYNOTE-XXX/EV-XXX is EV -XXX We The Phase which trial is advancing ineligible patients, chemotherapy. to platinum-containing eligible together Merck, are invasive patients III are a -XXX plus enrolling trial of with also ineligible trial, includes and be And In two are cancer, Phase saving enrolling trials. Astellas Cisplatin assisting supporting enrolling and both global confirmatory which Cisplatin KEYTRUDA. patients. KEYNOTE-BXX/EV-XXX as eligible intended global is KEYTRUDA

is non-muscle-invasive have BCG data we trial bladder In for and a the state is single-agent Additionally, opportunity EV-XXX pre of study, as disease opened cancer. support expressed PADCEV PADCEV intravesically this in now administered highly this in PADCEV. this -clinical non-responsive patients. Nectin-X potential in

evaluating and data for none a We esophageal head we solid including This initial high in net await enrolling is steps. and cancer. term basket our gastric are braced trial tumors, PADCEV also study to next expressing inform and neck of

an first advanced [Indiscernible] to study into ADCETRIS. treatment we several ADCETRIS Nivolumab as to At time in combination Hodgkin data expect to the on present from for have December, with meeting front-line Notably, Now [Indiscernible] the Phase for ongoing lymphoma. in presentations. we plan ASH X upcoming

advance continue compares lymphoma, clinical trial ECHELON-X, our Phase the RITUXAN. ADCETRIS REVLIMID RITUXAN to to REVLIMID large in X and relapsed including program, We B-cell and plus diffuse which development

and compared Our newest also in impressive, the for also metastatic commercial conditional Initial our breakthrough our has entry has already a for cancer drug The synergy The designation to therapy has cancer. from X an internalization data as proprietary This same ADC conjugate. for is s. in vedotin Tisotumab an antibody HER-X late-stage urothelial FDA. and development vedotin blocked gone already is payload the as was highest a China important characteristic approval enhanced antibody ADC into demonstrates delivers monotherapy gastric which which in in received when signaling Tisotumab.

combination inhibitor response and inform plans. PD-X Additionally, development presented data year, clinical this also demonstrating high will rates, were at our ASCO these

encouraging has are are monotherapy on generated future cancer We here REMAGEN for strategy. Urothelial with discussions the initial our HER-X breast cancer. we in to our evaluating partner FDA low-risk cancer, in And potential active data developments. regard development With

and we ESMO LV both the continue confirmed briefly of this setting. breast optimal Merck. with second line the LV, [Indiscernible] with evaluate schedule triple-negative as efficacy XX% pipeline. initial our monotherapy dose with Turning to we of cancer. KEYTRUDA and dosing patients the LV, being the early-stage in like third weekly partner efficacy LV that our results safety. I'd a in year, in developed of [Indiscernible] now At demonstrated combination in weekly presented to to mention and and now to regimen is which optimize Data data

X BXA, trials hematological X advancing ADCs, clinical and CDXXXA, SGN are malignancies, of We the SGNV. tumors in including a solid across range Phase programs and -

We year, which in PD-XX. At activity two least will more targeting at these [Indiscernible] robust in highlight models. on programs we BXHX, November, will preclinical for this submissions programs posters expect novel R&D anti-tumor ADC present and

function in antigens. including discussed, technology, We be as completed CDXX, relapsed to SEA also multiple with have CDXX, effective we subjects we enhanced with BCMA previously results ACA will our initial pancreatic Later disclosing patients of of with regard year Xr this refractory or Ash, of cancer. antibodies With enrollment cohort ACA-CD utilizing a XX, SCA myeloma. BCMA

year. from to clinical early those expect We cohorts data report next

to and I'll further also progress with have other CDXX updates calls. reach with In to development assess solid a providing and trial tumors, and including to important cell call - hand on initiated look forward non-small melanoma milestones to closing, our SEA now lung make and we basket cancer. the we We Clay. pipeline, continue meaningful future back you

Clay Siegall

this Throughout year, and important SGEN foundation core fuels continue and capabilities, milestones. ability evolving multiple and to resilient business achieved we a has expanding you which business. Thank our Roger. technology, solid our have

commercial the marketplace. to approved a medicines which engine compete portfolio and global allows of have us a proven strong We in

tomorrow's ability SGEN remain deep of development Strategic oncology and financial and therapies. We the enables fast exciting Operator, lives passionate a and for potential please open and and our launch develop, future capabilities partnerships, infrastructure, international clinical to we advance of have substantial and best-in-class the our Q&A. exceptional pipeline therapies. power is to line for improving patients cancer The committed worldwide. robust

Operator

question-and-answer We Meacham of roster. assemble will we from At will ahead. go Bank will And to Please now first our time, pause [Operator our begin Geoff America. come session. of question Instructions]. this momentarily the

Geoff Meacham

Chip. [Indiscernible] its guys, one the for one thanks Hey for and for for Maybe Geoff, question. Clay

fourth the thinking balance engine First off, your the investing how toward while that you Takeda the just talk launch Clay, us like to on about EU. keeping sustained reimbursement then next help Xmonths, different portfolio, geographies what of maybe guys and early over months even, you're And pathway have now about in that X OUS, you. profitability. maybe the or maybe product moving XX understand secure approved also you the running, Thank as in pipeline looks a the

Clay Siegall

for you questions. the Thank

Okay.

we've First had, last in of a really do very have approved lives. we years. products proud the of patients all, X that We're products in make we products the X that two difference have

in product. that continue invest mid-stage INGs Roger just late-stage, mentioned. strongly our recently early-stage to to We We submitted and

push And continue important move to biggest but together who Directors. Board it's we're it's with there. something the that. forward today some for encourage intend on, but to continue this with a pipeline time is guidance also going, to our us of to We -- and continue us our the us. to great and working will build where We to medicines investors of and our we're and not working also future, profitable. profitable, do to to when bastion of important be to on that's giving We're make

We in pipeline. our are heavily investing

difference our is don't big, not to But profitable profitable, please we way expanding where do be on right organization build is that we intend now makes basically products. that not is patients' and now. we lives. be pipeline, profitable, the that our think working by huge But So a it self-sustaining to note, could a in

So we're pursuing that.

to reimbursement, I'm sorry, sorry? -- talk the TIVDAK TIVDAK. a bit little as it about Chip, was initial you TUKYSA. do far want TUKYSA. As thought I and

Sorry. Go ahead.

Chip Romp

Sure.

We're countries So ex-U.S. Germany through that in continue the are as slow in working for the goes, process strong launches the and line. next as France. far with uptake

in We them. negotiations several with price are of

we of So reach to as forward, the the move we footprint forward look expanding product. for

Geoff Meacham

Thanks Great. guys.

Operator

ahead. JPMorgan. question next from Kasimov of comes Cory go Please The

Tom Prickett

the [Indiscernible] you. sequential then there in Great. Thomas conservatism that Hey, QX guide this in taking as just downturn updated revenue Maybe question. is the are Thanks one on Thank and [Indiscernible] element for identify is product here numbers Cory. for can

Clay Siegall

question. for Thanks the

First performance. of with all, we are pleased our quarterly and very year-to-date

in year-over-year net Our 'XX. of product XX% sales third were up quarter

So that great great, that's products have lives. make difference patients in a we

initial increased. so of but revenue other We we too TIVDAK now, right for have we which our all new our is also partnering, products, LTE X metrics, metrics, increased not only is X revenue increased XG guidance and our

maximizing that We're do this potential make Our to more that. really help to take lives, making patients footprint focus the is excited believe going worldwide. difference is drugs, of the patients. going reach it And on the not-too-distant much future. our some a going investment long we the in into and game, -- our that. bigger We're And investing Company globally, and stronger in about we're expanding labels,

As as the about fourth want color to Todd, quarter, a that? on give to you far thinking little

Todd Simpson

mentioned our giving and mind, lot We of the product the next with today really and on your to were we're continues job tried But pleased guidance third and very growth year we've we're result, as You with we're trying to mentioned, a strong, COVID XXXX our segment we're can and guidance, sales create best has annual modest really what pleased we forward gone, actually is just do in how quarter-to-quarter, we as as in a always did call. accurate guidance to particular doing. look up guide quarterly so we on just how just be trying Clay uncertainties that recognize sales do can. we quarter conservative, a that to the in with be to as fluctuate are we

Tom Prickett

Great. Thank you.

Operator

from comes Goldman Please go Richter Salveen question ahead. next of The Sachs.

Salveen Richter

should any granularity TIVDAK and of then the my next and taking timeline on at comment on Good expect TIGIT this programs? Could launch what or -- you LV just the updates afternoon. for we just on point Thanks questions.

Clay Siegall

Sure.

excited TIVDAK feedback. in on So a fields scene? the we about would about bit like Chip, it's talk those are commercial but like and it getting really little early, good really there market. to out you And what's

Chip Romp

oncologists. Sure. looking work continuing of We're excited It with from initial Physicians to first only with cancer had represents setting. forward really to closely partner the about We're pleased in the approved the [Indiscernible] option our reactions TIVDAK. the we've Genmab. and cervical are FDA [Indiscernible] having

Clay Siegall

to second And question, one at then time. switching your so let's start with a them

a is TIGIT of clinical trials. in TIGIT because and about little We and then number we're where LV. TIGIT the excited we SEA it's in you a it's also So comment bit the and of trials. from thinking is and are there in LV about product and could Roger, the what we're really think differentiated out that's trials other our technology

Roger Dansey

Sure. Thanks, Clay.

So for reason, with of TIGIT the environment lots proof-of-concept regards other to TIGIT, early program the working is we around good companies understand because There the on are there. us.

essence. of is we time So understand that the

move we We for work with primetime LV, partners, trial. to yet. hard yet, to datasets LV a also TIGIT can. continuing I drug, see ready not our optimize both you now we're dose can just developed are stay more is then and as we we schedule, in TIGIT Merck, hard clinically, regard multiple if terms know, be data able in we're monotherapy we and active on essentially for working Again, If need the tuned to that But there the expeditiously. not combination, unfolds. as we program to of can little a program. an We're but and way and that along as are demonstrate we're that. to differentiated presented meeting say have we'll With in the

Salveen Richter

Thank you.

Operator

next go The Please of Guggenheim Securities. from question Michael Schmidt comes ahead.

Aiden

Hi. question of This results taking Michael. congratulations on I'm impressive our quarter. this the is and for Aiden. for Thanks

We on [Indiscernible]. question have a

of of Now do what study? positive Phase be cancer. HERXCLIMB-XX and next second-line mets that a drive Do question could you that patients related in think in mets, HER-X with at brain towards HER-X. this, potential what results perhaps risk enrolling you you study the that more expect [Indiscernible] brain to study in the [Indiscernible] on reported study to And the looking the this proportion patients will are have What you. plus specifically Thank step? and X in

Clay Siegall

So the had HERX that X with questions TUKYSA. good brain thanks question concerning for on Roger, client. can the questions. mets you start they

Roger Dansey

Sure.

Clay Siegall

TUKYSA. And the HERX one plus Yeah. next on then

Roger Dansey

most with of just in with HERXCLIMB-XX mets Right. Inn development metastases. in as you With remarkable, patients the with is, [Indiscernible], demonstrated on need. patients attractive And such have infer know, know, of be a program, proportion metastases. you brain is regard drug also, our as like right an high a TUKYSA a a from sense. cancer, the and to see metastases share metastatic patients does we've HERX too, unmet cancer are to space which information patients frequency up holistic breast ADC together makes from high principal, develop XX% such a with disease neck met HERX of for can't as brain brain regards breast are positive to HERXCLIMB-XX, so will to HERX. any program as enroll, We to of next decent in HERXCLIMB, expected patients combining perspective, sort brain of it with interesting that brain in we will, a development the but TUKYSA in with through that now and cause, like complete it's active brain where allowing TUKYSA perspective, a enroll will drugs fact, we

we've done development had same see with approach in KADCYLA. that, that can program, As we've you our

in they we to data need generation. of what still wouldn't course, think point. disclose So those we're enrolling. will any looking the of We're those looking process this Again, forward. be. through if results may still could produce. at that of are the We're compelling, And forward process results to of We're what next in we steps

Aiden

Thank helpful. you. very That's

Operator

RBC The next Markets. Kennen question Capital Mackay comes Please of go ahead. from

Kennen Mackay

with Thank taking for I [Indiscernible] think congrats is the help wondering royalty guide guidance, question my growth. I the you Todd, impressive should and we you really us revenues. performance. on from for whether was or back where on the for maybe label that if quarter-over-quarter quarter, on from PADCEV just increased question the else. to then had quite another that something coming XX%, just a there, coming potentially, maybe it's after guide going about And and the could

us expecting you or related QX if on just and QX congrats a what Thanks is to them those to in dynamics Again again there understand whether help any the understand wondering here be performance. trying could Just decline dynamics. seasonality. could

Todd Simpson

Thanks, Kevin.

start me with let questions, good guide. the royalty up Some

are super then that great mentioned to royalties, that. two what so they're meaningful remarks to overall royalties, is sales we had amount driver with another -- guide, I 's both a PADCEV I happy mentioned that Company. it earlier earlier guidance, the think ADCETRIS well now not with we year set to forward a in And the growth, is contribute And pretty pulled did like in growth point thought where and to in but the of the call BLENREP, we're uncertainty related look X see into We mentioned see so when Takeda become standard on delighted obviously situation so and a Takeda's to I wind, of But out Polivy that supply Cohort that from nevertheless, of As we where we're Cohort in really it's these drugs the looks in And had water I as that you is we're those labels, again, want ADCETRIS, and I probably the It, want out. Takeda territories. of the a fluctuations. a to there's rapidly that than that for we commercial quarterly because doing QX. picture. our lower starting that got a then moving front the has we PADCEV happy I to way the that particular also stronger are. in to in million made both see principal in so was benefit We've now, reason probably ago than $X in it's X care. significant clinical QX, it's also

of all the we across PADCEV best the guidance, do board, to as our but been try well. just we can, actually, So

Kennen Mackay

it. for you Thank color, that Todd appreciate

Operator

Boris Cowen. The Please of ahead. from next question go comes Peaker

Boris Peaker

if next Daiichi on timing would the on the HERX scenario the Great, second you arbitration. starting that was dynamic they arbitration, April, and also, win in just specifically comment would But royalties could lawsuit I happen the of a just but what is litigation, [Indiscernible] lawsuit is there's lose maybe if on then on what or trial my the since -- question wondering litigation, you owe you curious a scenario? still patent the

Clay Siegall

for So the Boris, Daiichi legal issues. the on question Sankyo thanks

we have first there as And be in something end case from have per patent brought So forward, and federal that we guidance, there retired public announce of will the before that's -- those. said you're the judge findings being so about. April, the our been arbitration and believe we arbitration a the that infringement we year, which both the of all, is of you're in that so will a is right, correct heard on their

or patent we in We reading on. both we and based a regards, team. wouldn't great -- one another, on technology. case for did both the we with have based our have which on legal is The had that's have on arbitration, issued great really patent on we have that system, Daiichi Sankyo, the legal infringement that based comment our contract inner far its basically something As as a and -- workings we

the they're same, they're we feel So cases, a like both. we different have not great case and for

and difference a of patients' we're work also, from lives, thing away work partner. cancer we're with them, -- to it's The But most -- and we looking us make be and we So don't we forward. for drugs using in we go expect is important if develop continue they're expect technology we to and with do to with deals Company when our we companies, their to a a other lot that.

this And so is. that's where

Boris Peaker

cancer. And How that REMAGEN? me question licensed versus related ADC I'm does Got recently just the HER-X curious a follow-up breast -- the for that from but HERX impact an development [Indiscernible] recently your the for it. ask with to particularly data not maybe in strategy let litigation, the were strong so

Clay Siegall

of REMAGEN, of licensed which it's with what internalization. China. was incredibly Keds The we use road did internalizes data data, we unique think from a same kind interesting it's and its a approved so to know be that which area, we XX, cancer both component of Thanks They is based And or big bigger mind HERX it Keep antibody lot which to HER-X diligence the Sila we It HERX was for REMAGEN, HERX area see rapid been really selected REMAGEN original on, used impact patients. a that. as internalizes their that whether And things gastric high, the the that's in they something product able rapidly. Trastuzumab, it's that was on very one mean, ADC RC rapid in on have than this but that exciting. on which middle molecule from really internalization. fact in And antibody low did in we've is what receptive. based internalization the could of antibody The and I they're

activity We And data the have -- with is the other they They interesting. tumors and U.S. have inhibitors, ADCs very the with in see with is -low cancer breakthrough we designation HERX for other urothelial very cancer with even us nice have to FDA. combination with HERX such data our the -low in certainly breast dose checkpoint since as and checkpoint use in not which inhibitors KEYTRUDA. that surprising

whole We, have drug. great. our behalf see is important drug. think and goal HERX for career. we we love So drugs. good we new yes. where there. is cancer And all-in-all, on my That's It's we passion nice that's a profile patients, And but of This goal, my an very a

to patients anything different do there's that? room cancer lot that to for want think therapies. types of have a you Roger, add I of

Roger Dansey

Yeah.

things which we're includes we position molecule think [Indiscernible], that in -- in development steps active possibilities have HERX the it HER-X, [Indiscernible] and space. for are which properties changing is in that highly drugs which think and exploring and we a with have fortunate with combining But [Indiscernible]. is the with [Indiscernible] going valuable right with very like which with have PKI we in interesting. environment next program is are combination us combination [Indiscernible] then I like now. we're We're a in antibody what now And [Indiscernible] forward. we're external as small a in in We to combination regard HER-X [Indiscernible] of with [Indiscernible]. not There lots

of on those things think forward. I the are all table for exploration going

Boris Peaker

answering questions. you Thank for very much my

Operator

ahead. from comes of question Barclays. go next Gena Our Please Wang

Gena Wang

Thank taking you my for questions.

maybe low to and share Hugh would so MC another ADC. data And in question safety, to you wondering, REMAGEN the say still to So before of HERX how's anchor want compared would information sure that especially IP investors? compounds, then the X make how with regarding Clay, the the just arbitration, the just efficacy, timing follow also just comparison

Clay Siegall

part about the the Sure. it of question vedotin RCXX then turn of Well, I his I'll HERX. in try to over first and in safety will to to Disitomab differences about the view fix between arbitration Roger versus talk

end type the for something out than again, On that the release case, been on we're We our forward be we press I this case going shared it that the look in safety. to And once where Roger, on arbitration to investors. starts there'll think in would counsel, of external or We've of the and we the which arbitration, hearing some look case. year. sort resolved. feel put arbitration something based based probably on that getting forward We've patent that's case, a have we confident enable at infringement to sit some it. the with of that from prior better the strong not we and that, be think, internal on and to some now time like a resolution

Roger Dansey

HER-X from It's this But that an we in necessarily supplements the cancer. Sure. the may it And it breast will obviously to I be clinical generate that the think not what much as data the are. generated, and obviously, pretty profile, in and we need data determine efforts with our China we With of population that [Indiscernible] leverage China looks low, make own the generated has see limited to a as from the With has impressive. opportunity. not to U.S.. next as regards HER-X regards data [Indiscernible] also the defines program efforts the CGEN possible meaningful our to REMAGEN steps that HER-X whatever low dissimilar

Gena Wang

you. Thank

Operator

The William Hsieh next from go ahead. question of Blair. Please comes Andy

Andy Hsieh

about of the today. taking a congratulations Thanks quarter. questions, and EV-XXX question that for availed Great. kind the and beat study my I have raise on you

to sense. dosing about that in you. since thinking PADCEV, a dosing systemic in of Thank think XX longer terms the you intravesicular also And phase, for about at we about maintenance XX how of So usually administration your curious the also curious the about versus duration. is stopping month a think treatment

Clay Siegall

Roger, those you Thank for take questions. those? you to want

Roger Dansey

Sure. Andy. Thanks,

PADCEV The So yeah, cancer we're bladder meaningful. excited. opportunity could non-muscle-invasive be for very

But that predict. may to to question. The point will our a plan. that certainly so safe package initial We're hands little not I of to time therapy. preclinical trials expect the look Just to the look to commercially we be shared we dose PADCEV and beginning. just and our details current it efficacious maintenance. trial to we PET With all generate available systemic the least formulation, very systemic [Indiscernible], able define will than of eventual imaging. but remind have that a beyond will We not our to systemically. induction that, sort hoping little to trend in using be some it's through an we that using we the I to at seems at difficult this exposure. think good when of great Andy, you, Obviously, think the in it's way introduce points. a the through dosage, the has obviously preclinically, those itself, regard supports Understanding into exposed like, really bladder just post we're current more like presentations, the favorable regard With profile when are do what safety begun,

Peggy Pinkston

Operator we'll take the next question.

Operator

next ahead. go of Oppenheimer. Please comes Olson Jay question from The

Jay Olson

first-line some Thank types? Hey on you. combination tumor you expect the in guys, the for Can we thank talk planning and other TIVDAK data for about that you TIVDAK. quarter also, for congrats question. taking when And strategy your should to you're see

Clay Siegall

our quarter. about Thank the words you for

talk two data ways ESMO certainly little is a combination some lines presented We earlier for different going TIVDAK. us. you want that? about excited at Roger, important and to very about really bit are to We

Roger Dansey

reveal cancer, much an outcome. KEYTRUDA cervical of combination standard without produces but or addition as better care the recent chemotherapy The layer combination drug, a actually whose of [Indiscernible] [Indiscernible]. Frontline with another Yeah. is adds of

creates important that when seen we care, think So certainty the we've backbone frontline sort how TIVDAK and a based into an better of a to will on carboplatin see with believe regimen. standards be you element. about of TIVDAK the potentially than competitive, space combination that that current with the We it is is chemotherapy of move various regimen, combining as

need regimen We test an We we exactly that be we have element, doublet, shown need further. included consider we that into be the -- doing the also important we will final the what clinic Pembrolizumab in what the and frontline now. would to go that's and already be believe need to study will to and we're put

Jay Olson

types? tumor other And you. thank Great,

Roger Dansey

a publicly appropriate on to an plan present types, data are regards yes, tumor other time. With at we working to

Jay Olson

Thank great. Okay, you.

Operator

The Berenberg. next question Shu go Please from comes ahead. of Zhi Qiang

Zhiqiang Shu

that Thank ask going this present market ASH. to data going Great. you the to drug? see on you're very at I to guess, as we are opportunity I initial about BCMA presentation? the on this can What SG&A, comment Congrats well. much. at quarter you And for program Thank like you. the

Clay Siegall

Yeah.

is all, of CDXX there a robust that mainly out targeted is Velcade great to opportunity, an and market. It's area like subset on There's and of drugs. the and myeloma. antibodies ultra drugs this other First market REVLIMID

therapies So what what give you expect SEA there safety about drugs low room life in as there. but we're certainly talk to is bit MM, not that And presentation. little BCMA. on going drug with are for thoughts come it's as Until to the very a extended not ones signals, in, of really have said. appropriate out especially our but ASH is Roger on a different not obviously, patients, we to therapies present, and would there the always talk was we could have really color cured where These far great good little still like it the it. disease about could is there, and -- Roger, you the that first.

Roger Dansey

Sure.

little with as dosing the has monotherapy. and of ways in running myeloma. while program been a the ACA combination BCMA for essentially Dexamethasone at We've And So been it we've we've almost a evaluating clinical looking multiple a which mandatory it it. evaluating combination been been drug is various a now, with trial in

is initial of a BCMA produce mature data believe it's in public it's data us late at year. point, that enough line the we to at that that the time presenting this so patients data we this type to for in Myeloma enough, And will obviously we be and presenting forum. that We're this ASH and forward meaningful looking

Zhiqiang Shu

Great, thanks very much.

Operator

of The Benjamin next question Ren from go JMP comes Securities. Please ahead.

Ren Benjamin

data think expressing two And little to Urothelial we Hey, about I'd the more plan good Nectin-X quarter. only we going Are expression afternoon, Can thinking be how or the and us cancer, how that. a be new the should versus quite how focusing going option you kind about and to-date. asset is of of do I low a guys. HERX Thanks learn great just the Clay, this the a questions together. on you guys [Indiscernible] you on just development for work guess or about and tumors remind and of HERX love congrats taking bit potential to see forward. then bladder ultimately

Clay Siegall

breast already the that you'll at to the But I there's have can't long it we of very already an bladder data, big at cancer, up, considered of out hear designation. really a we entire is hatching slug building things cancer in have a [Indiscernible] past clearly, a we're been just wait we China. think cancer and looking look to Clearly at touching in Vedotin I this so you're Sure, important that and have -- point now But Tisotumab a gastric we it's mean, everything. lot don't low for cancer -- breakthrough big we've put GB. we're important where approved plan And looking also not we where on HERX from laid plan with so

is we're out a for right to forward possibilities it you take there's that to Roger, real now. a make scale, more think comment about a China on in track. I of this into -- which could very this different the want lot So well-positioned product get And just and question? do not global

Roger Dansey

really the cancer, in Yeah. because defined that some impressive. With up urothelial cancer, data of, something a population, by this in battle But point really regard Clay in work that need been HERX it's into driven perhaps [Indiscernible] is the this to overexpression, population [Indiscernible] account is disease, essentially, low. we'll opportunities population comes expresses this that's HERX the generated biomarker look our as it mind And that to identified. a the RemeGen -low sort is and a HERX which of amplification, whether as hands, population drug been in. for group we're that or -high all Bear traditional was HERX is mentioned, has, we'll at interested

on I the cancer. think and Urothelial our table, on breast all possibilities HERX cancer focus on is but initial are low

Ren Benjamin

about a Roger, do have with between exclusive? expression kind you follow-up, Nectin-X, maybe to bit expression sense of little they a just -- And or as as overlap of potential a HER-X the

Roger Dansey

limited. is we expression, near more sort ubiquitous. expression Nectin-X HER-X obviously as see of

I a have a that the population. of a epidemiology think defined bladder in accurate on. the of biomarker, that's But low it need clear or urothelial well-defined, versus patients. is groups that Obviously, we it the think and we'll forward. urothelial of high work of HERX bring is less HERX cancer traditional not And cancer, whole is I when cancer and distribution something view to we

Ren Benjamin

taking Thanks the Perfect. questions, for and congrats.

Operator

comes ahead. Catanzaro question The of go Sandler. Piper from next Please Joe

Joe Catanzaro

question Hey, and guys. Thanks my so in much for taking me squeezing here.

me. Just maybe quick one from one

new for So to trial. a you combination and looking on and had combination mentioned how that Thanks. at XX, wondering basket decision maybe in a little there start trial cancer pancreatic this bit elaborate your if experience your Roger, the you informed could you CCD are

Roger Dansey

Sure. It's a great question.

Obviously, and taking scientific inhibitors the interesting. an the why that that together with pancreatic cancer, tumors and into think pancreatic case, CCD you which proven really that's guess is is into exhausted It T-cell believe and [Indiscernible] agonist less cancer well as agonist, we strongly also I injure in potentially where with PD-X That we're relieve to is, I easy that in construct work. population. fact scientific other disease traditionally considered as the than well a not think already has responsive as hypothesis, treat. the a cancer be kill we together cells, combination of agents further to to is know, an basket diseases trials immune immunotherapy XX

So this think to it in we makes well. sense continue to tumors test as approach other

will diseases include why we like this basket melanoma. and trial opening So lung are cancer cell that's which non-small up

Joe Catanzaro

perfect. my Okay, taking for questions. Thanks

Operator

Question-and-Answer I would management turn for to the over like concludes remarks. conference any back This closing session. to our

Peggy Pinkston

Okay. your everybody a Have thanks participating rest good Thank Operator. you, in our for And of call day. today.

Operator

presentation, attending has The you and today's now conference concluded. may disconnect. you for Thank now

Seagen (SGEN) 29 Oct 212021 Q3 Earnings call transcript