SGEN - Earnings call transcript Q2 2020

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Operator

Good day and welcome to the Seattle Genetics Second Quarter 2020 Financial Results Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Ms. Peggy Pinkston, Vice President, Investor Relations. Please go ahead.

Peggy Pinkston

good and operator you, afternoon everyone. Thank like Genetics’ second would to conference welcome Seattle to you of quarter all call. I XXXX results financial Officer; Financial Officer; are and Roger Dansey, President, With Siegall, Officer. and U.S.; Chip Medical Executive Commercial, Chief today Vice Romp, Simpson, me Todd Chief Executive Clay Chief President are slides, you Investors Presentations will Events today’s section, on our Accompanying and supporting conference find call the which website in page.

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

Clay Siegall

past The a few growth everyone. Genetics of afternoon remarkable Seattle good and Peg for period been quarters you, Thank business. have the across

our of three commercial April. extended total of ADCETRIS sales by products. December, We quarter, approval TUKYSA portfolio million have followed with and the second $XXX these drugs product of the driven in reported to we In now comprising two new record revenues by the in approval PADCEV marketed

refractory availability we large additional expansion outline are Plus anaplastic $XXX the sales expanding in Most needs ADCETRIS, range ADCETRIS, lie which time ahead, and of relapsed we was opportunities pandemic. even quarter was ADCETRIS ADCETRIS addition, its fourth of net believe cell systemic across of frontline the from million Starting top this for secure $XXX progress maintaining and the tisotumab second on are our strong clinical lymphoma, to $XXX approvals of in sales million globally. global positive to-date, progress to guidance will our and of team for chemotherapy address in patients Based million TUKYSA the cancer In ADCETRIS his we net for continues label pipeline development dedication significant China Hodgkin in with announced full million. am line I to several ADCETRIS EU XXXX first the half a data important or made in accomplishments. medical and during of approved of advances to recently, Roger and ALCL. XXXX. program, comments. the a the with our making We unmet approved proud we systemic for reported vedotin lymphoma $XXX patients of year

of and second and or quarter, its U.S. the XX% pleased PD-X an of treatment Astellas, Turning million PD-LX metastatic inhibitor launch with and from a patients U.S. now urothelial strong to chemotherapy. received $XX a the We of QX. platinum-containing cancer be for who continue PADCEV, previously with net were sales partner, PADCEV the our in to robust increase adoption in

providing initial launch of expectations PADCEV. to guidance current full of We reflects strong are year $XXX now XXXX million $XXX the This following million. our

a end, that across of Astellas cancer urothelial of becomes Merck. and the vision collaboration advancing both Our treatment paired cancer, urothelial cancer. in are primarily To we foundation muscle-invasive KEYTRUDA metastatic bladder spectrum with is with PADCEV and first-line trials in this

brand. in We nectin-X well are believe of to an is tumors important also range PADCEV exploring that and a global expressing solid become PADCEV positioned

Our in to for third rapidly which was metastasis. TUKYSA, and with product metastatic brain mid-April approved by breast including patients is newest FDA HERX-positive commercial cancer,

TUKYSA Under the second our is Australia. EMA pleased our this submission EU virtual our are following program, is or And Canada. project More launch We quarter approval in application. in report reviewing now Switzerland, that for marketing very approved Singapore under employed also the FDA’s revenues million, is $XX of and currently methods. review to communication broadly, authorization TUKYSA

oversee most He are Both we will and President, area, our international Chip Worldwide U.S. look will build President, experience Romp, serve Celgene, where Patsi joined company’s Chip from organization Bristol-Myers together to Markets commercial we the who our with working lead as organization. from TUKYSA committee. continue deep As Tuomo patients was commercial including capabilities. and and and International. Executive continuing throughout ROW, us Squibb. recently Executive the to Vice joins in Tuomo he to forward this infrastructure in Commercial, the recently on has to us world, Tuomo bringing Europe

and Roger development regulatory which a program In have his HERX-positive across invested our we remarks. progress, cancers, commercial cover broad during will addition to

of recurrent or the Turning now in we metastatic trial or women line QX, our reported from with to cervical pipeline, vedotin late in TV cancer. positive top tisotumab results pivotal

collaboration the in together, full metastatic later therapies result positive results significant We’ve these feedback treated overall top Genmab, the to need. trial from in KOLs and in generally low year. plan cervical rates line to developing in with data and measured discuss medical survival Standard we We cancer response for FDA. previously this is unmet months. received our present with which TV the plan emphasize We’re on they from results

drugs, antibody-drug treatment the Beyond PADCEV which Roche’s recently technology vedotin the of growing our our is nothing data and ODAC XX related positive cancer. TV received a vote. is and There additionally GSK’s in Polivy, the our illustrate to conjugates uses ADCETRIS, vedotin also to ADC that now importance of approved closely based

growth Our for broad. the company are plans

include patients novel plan as pipeline, We’re XXXX, and growth, which need. to for on early-stage With to than and our later to as during to our immunotherapy we working other agents first-in-class regarding best-in-class clinical targeted to Yet, Day more preclinical virtual dozen a will bring in cancer. details information. fuel more provide advancing therapies tuned well we These our development. in I comment to Todd to clinical the hold expansive or over share expand treating commitment approaches the Stay discuss on that, in pipeline after Chip and ADCs discuss will turn development more future financial much each Chip? our R&D call Genetics will indications for results additional patients guidance, and our Roger need. commercial our is activities, in activities. a to help assets commercial of to our brands then our To Seattle will

Chip Romp

an for results the working commercial access our that is strong speaker delivered driving across creativity customers. in strategy growth We commercial quarter teams second our team peer-to-peer and increase to adapted portfolio. head adjusted We diligently Launching met to brand, on with flexibility. drugs reps X the challenge the Marketing a established program. support and work and and effectively with remotely, virtual new mix a world has Clay. and our marketing the Thanks, digital

the on that ECHELON these frontline X to X-year continue we And year. advantage forward ADCETRIS established follow-up HL both focus later data line and ADCETRIS, expect X is an of look durable ECHELON in the to For from and we the share. data drive trials and settings incremental both this will of front PTCL. standard, X-year follow-up

indication the academic in We in ordering strong and and are was community with labeled pleased PADCEV, is for uptake strong of continued both breadth use accounts robust. our

on are grow inhibitor. progressing that treated We TUKYSA first really our patients indication chemotherapy this to of increasing who And are number believe platinum-containing $XX and were labeled first-in-class We PD-X our along patients product. to we in the sales on launch, PADCEV. And partial early quarter sales of product, focused of finally, million. look our building the market the by forward PD-LX TUKYSA are or from latest share a on after in benefiting continuing with partners, success

pleased with mets. line brain which and are later second We label, or the with includes metastatic without patients

have are inclusion We among virtual pathways access and experiencing pleased of TUKYSA to strong to favorable in of TUKYSA awareness guideline advocacy. of uptake the both and rapid staff, treatment We TUKYSA patient high academic also driven In KOL are with community and placement, attribute field-based physicians. we and our environment, good customers. the the this adoption

the exciting this product team we as Tomo It with partnering the ex-U.S. and company to of commercial for an important to for forward look for TUKYSA. make we is launch I Lastly, prepare patients. the time available as

Now, turn call I the to over Todd. will

Todd Simpson

of the by million Polivy year-to-date in and and Hodgkin lymphoma. quarter from the royalties $XX This profit Thanks, and reflected in outlook primarily the quarter Total Royalty by $XX year-to-date XXXX. quarter million to for of from in then the Roche. joining the and million XXXX. million We XXXX. franchises, today, second for the for million, and $XX year-to-date for million were the lesser milestones Great. EU degree, $XX the $XXX second sales in sales, reflects Astellas, $X million on other quarter of three revenues of Cost $XXX on and in in ROW the includes Cost achieved to and XXXX X the million the Revenues the year. over for year-to-date. I in year. in $XX second quarter million Results call to to the XXXX. periods $XX oncology and million XXXX for of compares which our this million by $XXX million of Takeda for second respectively were were thanks second totaled $XX and by our product everyone by a second the $XX afternoon. that us first million of for will last on the triggered were XX% months up million sales quarter sales approvals increased passive results Collaboration Takeda Chip sales and financial summarize was share XXXX. the revenues for revenues Growth and driven ADCETRIS in same comment which our frontline $XX ADCETRIS for $XX remainder year-to-date in were in

over in beginning to R&D In PADCEV approximately million expenses we now will a to of turn for cost XXXX. $X increases for XX $XXX to SG&A in were million investment that $XXX sales and and mentioned, to April are from first for These quarter we maintaining the includes addition, is our We of and in our the pipeline programs the that of full $XXX clinical This forward quarter of XXXX second respect the to contributed amount going expansion. non-cash income and primarily million quarter. of the quarter XXXX. in portion acquired shares, Immunomedics million commercialization European for acquisition. reflect our of XXXX million remaining This will now outlook as investment Clay guidance $XXX product increased the cost cash in passive quarter. These now I the $XXX second guidance Cascadian $XX sales and the and the million year $XXX half million sale million million half per $XXX component to in amortization million of range of were $XXX includes ended to increases first the the the and in $XXX XXXX are the over with reflecting technology-related providing of ADCETRIS of million quarter, the sales, are investments. of TUKYSA in XXXX. $XXX across are second development. second our With our which of second includes expenses million. financial

on to Moving in $XXX cost XXXX million range to expenses, the of million. be $XXX of sales to we expect

and PADCEV, cost related this now share includes acquired of amortization to Astellas payment mentioned, sales, product technology profit As to TUKYSA. for of

SG&A year, Now that of unchanged. we halfway expense are our refining remains million $XXX through R&D we $XXX the to for a million to for expenses guidance and are range guidance our

So with I the over Roger. call will turn to that,

Roger Dansey

ADC late and TUKYSA directed our tisotumab products, will start with Todd I ADCETRIS the our well afternoon will and everyone. approved as on vedotin. Thanks, Today, focus as asset, I Nectin-X. PADCEV, stage good against PADCEV,

cancer this the ubiquitous earlier of We year. development this expression cancer, urothelial urothelial Given completed of trials in previously the to two be continues of Nectin-X program. metastatic enrollments focus pivotal in treated our

promising a designation. need in trial and cisplatin which Based trial FDA have and treatment EV-XXX setting. second metastatic confirmatory the with eligible second, in Phase is indication who and and X is EV-XXX PADCEV. The regimen combining are approvals. therapy KEYTRUDA, to pathways patients in or in data line support PADCEV have global supports States a First, urothelial in of previously not and a findings, who first-line or address the EV-XXX the pursuing cohort a inhibitor the two And second as trial inhibitor. intended disease. United we overall survival endpoint primary reported frontline PD-X outcome PD-LX first on received to a patients PD-LX for to these breakthrough have cancer, the A unmet could platinum-containing we both positive serve Switching regulatory received received for the randomized were PD-X

XXX or primary enrolling objective are of This EV-XXX a by response. of trial. cohort endpoint in we supported alone endpoints cisplatin-ineligible K in receive to duration patients. plus randomized response accelerated either is of approval the PADCEV key PADCEV represents secondary The KEYTRUDA opportunity patients the rate First, potential

The we trial. in in and the KEYTRUDA for endpoints reevaluating randomized platinum-containing global EV-XXX urothelial registrations the dual of due strength support as PADCEV EV-XXX the Phase cancer need serves States. Together evolving progression-free arms we Astellas is a first-line chemotherapy enrolling is on trial PADCEV and to evaluating primary trial a intended to experimental confirmatory are the landscape. amended United Second, plus focus potential regimen. with now trial the are survival. and the two also to KEYTRUDA The that our Merck Partners, overall are the and would compared data This metastatic X

This cisplatin-ineligible given cystectomy bladder planning recently evolves. We trial Phase our development is Genetics added and agreement will PADCEV in and now KEYTRUDA PADCEV under conducted setting. study. prior non-metastatic a combination in TUKYSA. cancer, In PADCEV X fund then are Merck patients operationalize expedites clinical to trial keep neoadjuvantly muscle-invasive is I KEYTRUDA meaningfully and move study being and This This will you providing on the therapy. as to to trial. postoperatively will assist posted Astellas KEYNOTE-XXX PADCEV randomized continues this to the adjuvant Merck where and the Seattle ongoing as of plus

evaluating the breast are focused breast called patients on TUKYSA, we As cancer, cancers. made and regulatory study Clay X brain In we trial HERX-positive cancer, Phase trial. in we data remarkable metastatic have HERX areas: with further is several therapeutic claim based versus described, conducting a a rapid To blinded, colorectal HERX-positive progress The securing line and cancer, second metastases. KADCYLA three in develop with other cancer from T-DMX breast in randomized initially in first alone combination including approvals are TUKYSA or HERXCLIMB-XX. KADCYLA gastrointestinal

gastric, HERX In support a approximately with X,XXX trial esophageal, by in group in called combination TUKYSA patients be with Compass HERX-positive being is U.S. now will the addition, a patients MOUNTAINEER Genetics. patients trastuzumab In and is relapsed chemotherapy KADCYLA trial Phase will to This potential first-line RD to colorectal, metastatic in support X TUKYSA and and in plus double-blind is trastuzumab for the accelerated approval. cooperative KADCYLA in setting alone conducted a HERX-positive breast evaluating disease. is cancer. evaluating cancer, high with from oxaliplatin-based compared underway, of Seattle relapse. colorectal The cancer And with TUKYSA other risk GI randomized gallbladder adjuvant trial plus enroll cancers, intended third-line

setting second a plan trial In addition, gastric year. the cancer later this initiate to we line in

TUKYSA AACR cancers. month mutant last we preclinical mutant HERX growth amplified to selectively are showing models. in TUKYSA We tumor planning Beyond its inhibited to at compelling areas, HERX these data that in presented evaluate also three

of in Additional novel combination anticancer planning. also trials TUKYSA other with are agents

ADCETRIS, REVLIMID now XXX We alone randomized are on additional initiated trial combination Phase relapsed/refractory patients. trial to large evaluate ADCETRIS, opportunities. REVLIMID Rituxan and Moving The B-cell of diffuse in in we and studying several Rituxan a will recently versus X lymphoma.

X of enroll treatment will is and CDXX-positive relapsed monotherapy intended for levels. DLBCL, support label regardless in expansion patients ADCETRIS to listed potential NCCN trial this While expression guidelines CDXX is Phase

We enrolling frontline Hodgkin patients trial Opdivo are evaluating chemotherapy plus and a ADCETRIS in also in lymphoma.

X cohort Squibb. with patients Stage We X with of Hodgkin have a Bristol-Myers collaboration added lymphoma clinical or a under

reduce by to Our regimen. improve the chemotherapy the goal of in is components efficacy toxicity limiting and number

on will progression response with epistaxis, or cervical fatigue months metastatic events and I of recurrent duration Lastly, turn alopecia, had line tisotumab experienced adverse eye. In nausea, June, to treatment-related X.X chemotherapy. late response. positive a women XX% results who evaluating cancer vedotin. innovative TV disease rate data after in included we dry median from top the The most showed reported agent The with conjunctivitis, trial, common single or objective XXX

We at in BLA accelerated the other and a potential discussing used believe head and and advancing are solid maybe in will approval. in cancers be expressing Genmab we and tumors, results Innovative TV factor treatment cervical results ovarian, lung the of solid FDA tissue TV in clinical the also study. with XXX for other submission cancer. consideration there to of neck combination We support of with from opportunities in these by tumors including encouraged trials partners and agents We our the several are

turn call Clay. over will back to the I Now,

Clay Siegall

this year point, continued a to we look Q&A. in questions. Thank very Roger. the and for difficult teams this have with for open please line to significant pleased will you, progress. call forward Operator, am open We I environment. how our great accomplishments adapted working At the our

Operator

our Instructions] question will Michael Please Guggenheim. ahead. with take [Operator we go you. from And Schmidt Thank first

Michael Schmidt

just the Are there? TUKYSA. the in could seeing We how novel I favorable provide being bit initial one how quarter. very label. going of just to wondering had for is use very launch little Good regarding guys. and from Hey, on such the uptake? are around insight a feedback terms I was example, drug you what the Chip, physicians positioned you second its And you to other more marketplace seeing on example some as, Chip, afternoon congrats some agents, and initial if HERX? relative received a successful second-line in for is for

Clay Siegall

to Chip you you Chip, comments? that keep color can thank in early and Please the question. the very that for some Michael, mind you like pleased And some launch. in Yes, provide it is very make can’t. would

Chip Romp

provide you but Thank the the the early the happy of with question. academic are settings. Absolutely. launch both to seeing, in are that with along we level new is for specifics, really too the It awareness uptake we and in

We are includes seeing working or with are we that are And patients uptake to metastatic and second hard with to we without mets. awareness. and with which line [indiscernible] what brain regards label have, we later again, pleased

Michael Schmidt

Okay, you. thank

Operator

Thank you.

from our with take question Salveen will We Sachs. Goldman next Richter

Salveen Richter

so Good of afternoon. when in conservative, you would questions. Thanks the to far, that year the for taking play the half in first regard PADCEV, what the look guidance just at versus half? run-rate you comment on the my at the appear could you factors saw second With are

Clay Siegall

Sure.

we I been question. on got way, communication only for dropped by heard we that’s so from on. have you the will and going thank that our been apologize that have get the for call change whole please note, And website. any that at were And dropped error So have might off the the there people some operator –

that. for apologize I So

question your So, on going to guidance.

level launch guidance. in of want but the provide to we PADCEV, of So it’s some early did

as growth see can XX% second and our from Yes, first been somewhere very half rate And to to that the strong strong of We it’s was rate. doctors a quarter. a half, hard growth at the it’s XX% second drug unusual the quarter. second a in we with really the to patient So rate this This the XX% just every a and certainly launch quarter first working progression. important launch But work begin growth that first help the so, reported getting guidance is to need, sure patients. over between uptake. to making slow shows in growth far, not the

pleased still to healthy of XX% of able But are a growth are on. growth going to be over not year. quarter-to-quarter. the show what’s strong for guide XX% we very is going really see a half And with to XX% first We our the

Salveen Richter

you. Thank

Operator

Thank you.

We will with question Cory take Kasimov our JPMorgan. next from

Cory Kasimov

data you can question. potentially gating kind that Hey, factors to good terms latest now that I just into? at with guys, thanks filing? a in-house. about to curious I this And wanted you point, just of Thank you TV. And in commercial of my the but have growing the guess, you how am BLA of see are the afternoon what taking Clay, you. for I What And your opportunity? are thinking initial remind here this evolution us positive

Clay Siegall

Sure.

is we collaboration be with as as data. BLA, once really to data, far to are patients. and excited Genmab So pleased are able a have we we help our with really This our

out other we of very are our little we that But some to low. that there. patients yet data are And have put very are has be of in [indiscernible] doing response incredibly what rates proud

get a our a to positive. think I on so going folks mistaken when and plot impact our big chance to be And really see

the and would to have So, be provide BLA I actively a working make we you level say. connected regulators. – positive for not submission. are by regulators trying thing And data. certainly that you today don’t go to information appropriate because it appropriate you need confidential to information and hard have toward working But that on a we this don’t that of sure to until But could with we encouraged discrete along certainly are all we had know very our I

single then combination best is metastatic as in approaches. goal with way agent, agents. is market asked beginning absolutely single our question can initially can looking as that I many here. will is that through agent, to using other be impact commercial be another combined something relapse/refractory patients relapsed TV. And with sorry, the that evolution something but the really a also can think am TV notes but It my think cervical cancer. you at about we the we Now this is a for – we the cervical be And cancer

And certainly so that as on we we are working speak.

on are we very other hard types. addition, anther In working

We that of substantial trial basket for. amount a have data we a have

at point that as reporting future some the of speak. in we some are we be will the and expanding We cohorts

So stay tuned for [indiscernible]

Cory Kasimov

you. Thank great. Alright,

Operator

you. Thank

Kennen now RBC with Capital We are from MacKay Markets.

Kennen MacKay

on for taking excellent much so and to thanks operational the the team congrats whole quarter. question Hey, the

TUKYSA, the has one and prevent, the ASCO cancer occurrence was wanted on understand impact congrats treat, the highlighted drug of of earlier second certainly again. but at breast usage the sort HERX that label? to metastatic, to in really question of brain the session used feedback I really by mets. And the So, if been? And is only to TUKYSA all so what breast which [indiscernible] Thanks drug was highlighted cancer much not allowable initial is and getting advocating positive lines to launch line is in prevent

Clay Siegall

of So asked congratulations. a questions question, couple your so within one you

will I – So, no worries.

over market As make dynamics fantastic. to of And Roger far comments? you to talk turn are as treating how etcetera. some paradigms, the can And a and uptake, then the bit looking we the at and color treatment can it little that’s give to Chip, maybe, you about

can you Chip, ahead? go So

Chip Romp

Thanks. absolutely. Yes,

been include easy So addition new to yes, and as patients. does seeing. the brain second happy which these we without we that we that and the TUKYSA. two later for with a have are line promoting adoption treatment have patients only tool with we they even have seen have label, And again, regarding valuable a are but significant again, mets, used Doctors

Roger Dansey

will Roger. here. It’s commentary add And some I

ASCO dataset presented was at data patients remarkable. is that looking So, fashion. metastases largest is at probably brain prospective with This this in the the

metastases prevention progress people further not having effect treatment metastases do direct to really is brain which on control. TUKYSA what so a And any outcome, and brain who had secondary represents compared

have in think same pointed with we allow TUKYSA expect treatment shown it be to data. think ever So that out, the one Kadcyla as drug HERXCLIMB would to other does various used. that convincingly patients place as would be for we the the very We relevant label strong a a metastases. with dataset you have I we overall as And is brain survival hit. expect I endpoints you think is like strongly Again, competitive and

bring good they we treatments in the consider proposition patients about forward to and think So, a metastatic what physicians value as have they to space. should

Operator

Thank you.

take with go next will Please question Needham Company. our from Chad & Messer ahead. We

Chad Messer

a Great. to be the you is of of caught treatment what might one as as Congratulations at well Slide for you. that out I allowed file take taking of of – detail. believe to relapsed maybe XXX well that, that little bit try, that you a was as sort Thank is have question. it’s #X, could are I single trying Can kind my quarter on get multi-arm a are naïve. And just good I to accelerated? through we was thanks agent and confirm kind know able us you and I are looking confirmatory you a combos this trial? of think more as Innovative in you of as hoping lot you assuming you

Clay Siegall

Chad. would you question? that take Roger, Thanks,

Roger Dansey

Sure.

So it’s are evaluating. a around cancer we cervical essentially and test

example a setup trial work we TV say. is and to forward represents have both would vedotin in a for whether path there with a It’s out XXX on also cancer. may to looking single-agent therapy basis the basis combination I agent pembrolizumab as beyond cervical and trial data that scheduled other it’s is TV obviously what The are basis line shown of a signal have a finding tisotumab We whether to a is not trial, as chemotherapies. understand for combination as or a single and/or a where still [indiscernible] role

Operator

you. Thank

take from will question We now Gena next our Wang with Barclays.

Peter Kim

strong a question I regarding Hi. cancer. metastatic quarter. Congratulations on This had Peter muscle-invasive is Wang. – bladder Gena another for the

XXX what much. and very J a study. KEYNOTE Thank to on mentioned in EV-XXX of you role the XXX? about KEYNOTE will relevant So you H the us you context Cohorts the Could in plays remind

Clay Siegall

cancer. you muscle for something make the Sure. Roger, It’s invasive Thank question interest to a bladder us. big you very comment? specific on can a

Roger Dansey

the thanks for Yes, question.

finding So, or – was were EV-XXX set signal cohorts for the in cohorts. designs up the original

bladder a muscle-invasive KEYTRUDA like. and to monitored understand could So, also and in look eligible we we understand try to EV a population what on would system needed combination what needed PADCEV, like have and focused look

However, strong a of to plus data PADCEV combination lines of we for that a actually leap into no have disease combination such in strong activity faith with PADCEV metastatic we with difficult have KEYTRUDA. later trial. us It move very randomized really was and

So leapfrogged PADCEV I into in space. development path cancer remarks, the my and this made really system as muscle-invasive comment that for part rapid was a bladder of us eligible

will cohorts still run. two those So

we have will the already moved X We trial. But data. generate basically Phase a into

Peter Kim

you very Thank much. Great.

Operator

you. Thank

Andrew now Berens hear will with ahead. Please SVB go We from Leerink.

Andrew Berens

the on execution across guys give wondering commercial PADCEV Congrats I on you if the board. usage. the Thanks. color some could was

are with that wondering is KEYTRUDA imminent I We was that endorsement remove NCCN the frontline. some you are that could would and the hearing be expensive docs think whether in using how potential on And to just one know how I concerns? sense drug? just it’s one, then get reimbursement the other or some of long staying – in patients launch just early are the

Clay Siegall

Andy, you, thank So for the questions.

we an in with So, global, only XXX in were speak Clearly, well but excited patients a of on underway. that’s are spontaneous confirmatory were And patients that KEYTRUDA, with PADCEV we as and use negotiate that’s with KEYTRUDA, trial the large powerful XX and plus plus opportunity that KEYTRUDA able adoption frontline. with is comments XX enabled we an with not make us our trial And and patients to first accelerated PADCEV very data all, obviously, off-label about regard. can’t to with frontline regulators. with that which

comments maybe, on question, and go looking to want about how are we at further you this PADCEV do before – and Roger, we and frontline make any this? So

Roger Dansey

Sure.

have But It’s involved. of eligible carefully. plan. system-eligible waterfront dynamic. we a is is we covering versus we two-pronged are issue are complex. patients. the space And biomarkers very really frontline There the think the So, system There

Clay that fastest cohort trial. first the our because a So it’s outlined single is path, arm

that open it’s enrolling together January are primary rate We cohort has been response of duration overall with is objective since outcome and response.

obviously look soon we data that outcome an enrolled as that’s have we everyone. have So, available the as forward we to

plan important are much component. to larger eligible they to global not on The basically second piece trial, which is is really, And is there now takes patients, all it do whether randomized we also simplify a is system which approach. or our what very

cancer to PADCEV not, PD-LX So KEYTRUDA bladder on. a or for and regardless eligibility of going really this of is disease so platinum frontline plan for status metastatic regardless now be

Clay Siegall

part little making to that. that. a question, drug comments second be your specific all Andy, Your about really is on and It’s on early of staying

I XX% statement. a would our look are period say on to at think behooves us we quantify to for It’s But that. of care the time way have with standard were first we well goal strong, in proud of be And done hard what very it’s therapy it big the things. duration that this. of I of the are big with which to increase to start a PADCEV specific within label is that. making very a with the to longer and we But – a that’s quarter, from sales our

We are there. it out getting

hearing We of all are helping to patients. are Doctors and are we to of on care. relying them more this standard

as want is that think had know comments, you do on from a any used? just we have it value towards And And that something staying are that’s So and pushback market that this. PADCEV And acknowledgment strong so proposition have we brings Chip, about important how very payers, proud about to PADCEV and that’s we okay. patients it’s something other are think no we dynamic of. you being drug the really for that’s you

Chip Romp

Clay. No,

I label your think of promoting full We the are on that breadth the is I we echo commentary again, have. would the only payers. And the thing

whatsoever. pushback payer no seen have We

strong place. very have in We reimbursement

Andrew Berens

it. What about on Any the color process? that’s Okay, appreciate how I NCCN going?

Clay Siegall

with work NCCN. We obviously

NCCN many different for have listings We products. different many, our

we and PD-X that’s some PADCEV platinum. in have and oncologists ways those in to for different line who as placements want we they of have who guidelines heard And setting, pathways such certainly favorable eligible but received or the use important. sometimes aren’t in get And PD-LXs current

not have we oncologists. So And some ears little of to a that’s those. we to But talking have different. common we about heard practice. our a It’s feel blue

possibly we We can. trying that are out figure to everything

provide the really NCCN on is really our say for As but lots the that time. them. any in of of up products information NCCN, far this to a We matter, have all don’t we as

something for. that’s look So, we

Andrew Berens

the questions, a thanks appreciate Clay, I Okay, lot. Roger.

Operator

take Olson Oppenheimer. from our question with next We Jay will

Jay Olson

And from was you detailed and you on I results question. you basket which thank comment what impressive. on all about? cervical for top taking the The my we you for year? curious congrats the the can were Hey, line XXX success extremely beyond later most data for And present TV when look types this trial, about optimistic then should tumor are

Clay Siegall

Sure.

drug with X% was was rate in The XX% drugs you cervical an mentioned response cancer, poor. and it that TV recent that in response the objective cancer proud metastatic data. metastatic patients with all are of approval was in have before I top to only not the setting, most So cervical and I really really it’s high, got Historically, PD-X rate. that line KEYTRUDA so XX%

just could And disease. difficult is you tough from that to this very see treat how it so

line the look And mentioned trial they And waterfall exciting what’s bit could Roger, and trial for so looking the we little maybe, are but we at? a data? about types excited what maybe could the about talk that. basket talk are main about I earlier you top the can in about the plot, you in

Roger Dansey

Sure.

So, historical great. therapies can be the datasets the you benchmark that against of pointed out, we not as there are results are would But obviously, existing that different Clay use. measured

outcome. an So, thereabouts low quite be good double-digits or expected outcome, would probably a

being and mid to we So, is data important in generate is as event think to close response the XX% rate an important able durability.

have whether the TV response time-dependent forward, endpoints, factor certainly as have they that very area to that agency’s excited XXX tissue other we unmet able foot a we need. profile. targets. best we data, and see of It’s But will duration with we do our is will because median make. to good case for determination think agree this sort that, show. really of we when safety We other we the put validating Obviously such the entire an to high of provide but is are the present by We endpoints the been

does two responsive. working general or that it tumor And exists in possibility is tumors, as potentially in that are so the other may we obviously, when with find an another ADP we platform

those So particularly interested in and and the have we head trial, in we cancer, We any cancer, too. we cancer have already have we colorectal we neck presented we think have And but would TV have are find basket already – be latter two obviously, cell pancreatic we lung is non-small that cohorts and I cancer, shown cancer. haven’t – then of active data, interest. that in ovarian

we a current are the any disclosed other to a fashion, tumors. determine in obviously, we cancer, role information So for effort but And but TV have prosecuting those cancer broad in not a we data, in its not of ovarian on. going also have role the whole only cervical potential

Jay Olson

Thanks again helpful. for again. Super the question. taking Congrats

Operator

Thanks.

will our question Meacham Bank of Geoff with take We from next America.

Greg Harrison

for Harrison question. Greg this is Geoff. for Hi, Thanks on the taking

pipeline you So profitability you as color keeping about next $XX guidance, through more in year moving Can your to million, think grow trying same. pipeline and the reflecting? we pipeline? R&D moving prioritization you raised provide if is And else while increase think this just forward expense well, the on which the this should of everything as the about into programs

Todd Simpson

for Thanks the Todd. question. is This great. Yes,

clinical in the progress down to incredible COVID of new we some – the are drugs harder So refinement. reduced it the little it. and the making a that trials to clinic, bit, a a It’s clinical our bit update bit. reflecting bringing related of a guidance narrowed and in I brought is expanding we midyear despite we’re But particularly We little costs guidance with areas. just clear, we hit just some lower want be

a counterbalancing were We of didn’t but launch really is the we presence earlier of and launch out and everyone just some change strong And seeing these events, and scientific similar travel about sort knows, starting has have, seeing now decreases at than very had guidance, We’ve of next TUKYSA, but we gone meetings no our obviously, capabilities of European as in X.X% that congresses are and but was we I are also think virtual. traveling. drug one the that SG&A we’re building year SG&A

Greg Harrison

you. thank it, Got

Operator

will Thank Matthew take question we with our you Harrison Morgan from Stanley. next

Unidentified Analyst

Carlin on is for Matthew. This

in But just a maybe pipeline? brain no about you net physicians most quickly you see has the bit for to of KOLs to to We expect with you that, hope little And thoughts versus on antibody the And been So just hear versus your on similar other think need And patient a highlighted press feedback differentiates do do on positive there initial date more far? med what been collaboration a CTGT and or late-stage partner what release. your with you what that kind PD-X in TUKYSA. then or thus future combinations do population? have combinations?

Clay Siegall

Sure.

question, first TV? that I Is the TV talking your and heard the you think – setting. were in was I correct combinations it about

Unidentified Analyst

was think yes, I it – [indiscernible]

Clay Siegall

TV. Yes,

about are Roger, we about are going So combinations to forward. little bit would you a we excited TV the thinking and like discuss of?

Roger Dansey

Sure.

vedotin strong of rationale are is we the generating with adding sort mechanism payload the were cell of cancer So think adjuvant as to to ADC – or come not cells, vedotin can have just boost vedotin an killing back It’s We combining a general platform, immune a PD-LX on of the based PD-X for vedotin pretty of TV, one data. immune the death, think But inhibitor. do increase tumor. together scientific of important you profile we the essentially sort which immunogenic to system, the which we think the is but only it plus. sort inducing

lot to chemotherapy, of combine focus a interested, is we’re obviously, also there if are So to with combining need test our that. but reasons PD-X, we with

what that testing. is So are we

Clay Siegall

So that as far populations, have and those not. are do both brain as patients TUKYSA patient treating that and metastasis definitely we

in being there are the And community. out both we’re treated. So

there in major university. out medical We’re centers,

helping you there. this great with exciting talk to hearing I’m And patients. what TUKYSA happened you’re been So really sure uptick. a as that But so with to future it’s far. out having getting and look forward pleased we’re really And docs broad product we with

Unidentified Analyst

Thank you. Understood.

to you the guys on your on question, just And X? touch to that would be the sorry, initiated possible base antibody, first you mentioned just – CTGT but that just Phase also it

Clay Siegall

Oh sorry, – I’m sorry, TIGIT.

results is in TIGIT that Yes, I that Sorry, does It’s our utilizes And a what not but hard, little absolutely, sure. SEA human yes, non-fucosylated of our muffled, IGGX a so technology. so kind antibody. was antibody okay.

that’s And important. really Okay.

very And data into preclinical SEA the want and it. data that X data – But that And of versus get SEA TGT with there a in can we’re tumors. strong started, has differentiated it’s excited Phase if or package. variety the Now profile says TIGITs. The potential has – incredibly preclinical TIGIT it’s already I to. very is other you different

ours So come that this work in could with TIGIT. product now, they which the very But Merck leaders very with the in we with are activity. a we compares think exciting are and think differentiated and doing well Roche be clinic and

Unidentified Analyst

Thank Understood. you.

Operator

now And question now with Hsieh our you. next Blair. Thank William from Andy we take will

Andy Hsieh

on Congratulations quarter as everybody Genetics. Seattle at hope spectacular well another and Great.

that population has question effective more PSC the enrollment trial. in active to in of the kind to do you of my DCB DLBCL Could subtype? I strategy difference of the sort Phase significant for III you activity you. between context can effect? remember in relapsed/refractory So ADC there with the lenalidomide ABC setting? optimally any that that Thank an remind that Is subtype of capture there ADC combination, the the enrich is and

Clay Siegall

the saying spectacular. you of was that Andy, all, for, first quarter thank

with in increase Wall first We quarter way a thought would had proud of I past where be. big and were Street that. we TUKYSA PADCEV think we very have a XX%

So spectacular. thank you you for the word

it turn As will I over DLBCL far and as whatever, treating with ADCETRIS Roger. and subtypes to and

Roger Dansey

Sure. Thanks, Andy.

perhaps for the – are are type DLBCL. have And is use of top listing ADCETRIS also but may entity versus suggestion ADCETRIS there’s be negative a do REVLIMID patients. enrolling have populations – we is so. you can this are we and all have subtypes we CDXX showing right, that expression lots of around activity only from believe not by but there that in a standard all X perspective. why lymphomas, IHC, is XX of shot listing level discussion We And that for ACD on good of it’s and other, we with or content focused So, X

with of expectation we So the all-comers out, sort a groups better combining potential different the reads obviously, I perspective, effect any combination are DLBCL. as are group the really trial across there of from relapsed/refractory an our Rituxan. But REVLIMID evaluate think of together is than expect that and should sub that DLBCL pub is if designed as treatment population, this ADCETRIS others. the we a really trial types see And in

Andy Hsieh

so Thank my Great. for much questions. answering you

Operator

Thank you.

We with Capital George will Markets. hear BMO next from Farmer

George Farmer

question think this my some the congratulations if great Granted, community, awareness doing to this but taking was us in with you for of that’s I others? is have what is guys the physician the quarter. pretty what’s on among you of thanks virtual ever. was what and there guys been really you do making insight yes, one PADCEV. stand great process one – behind give a probably going on kind out mean Hi, wondering could you I this first all launches from

Clay Siegall

then are could out And virtually. We are bit a start with And got. Chip, label. incredibly about doing we this you little the maybe, how pleased label our Roger, maybe could It’s label. we could about you that with strong very talk we it a very, talk

Roger Dansey

Sure.

best-in-class – a the represents essentially, TKI. TUKYSA So

had the good it absence deliver ASCO, prominent second a label. at strong at I favorable up the December, the So of small of then think was where presentation San of desks very arrive we’ve for fortune Antonio a But having I inhibitor at presentation class what again, patients and do. that incredibly other the plus does doesn’t with molecule follow data promise think We a in appreciated. well molecules. in And on clinician can it a data,

think foray in better to for view potential now. woken couldn’t from terms place TUKYSA, honestly a public sharing than have use I label at and the have of we information what we So of point a would for the of recommend

Clay Siegall

you dynamics? touch market to like base on Chip, would

Chip Romp

Absolutely, Clay.

think great to adapting the I communication. has So the job virtual a team done

receptive have customers Our been to that.

grew X. also You from rapidly product X to

and together been collaborate some the our team appreciated working commercial well. brands, on to that as there’s So synergies across have the customers

to face also have customers. phased face begun We We a interaction. sell in to reintroduction

We hard to critical have awareness sure high working brands. there’s make all across been

George Farmer

congratulations. again and thanks Great

Clay Siegall

George Thanks

Operator

you. Thank

JMP Securities. hear will from We Benjamin Reni with next

Reni Benjamin

question new going, us to reviewed we on some to my how quarter. afternoon the for questions being thanks that’s the little be EU you rest Hi, guess about guess And awesome I the how you might I good CISA can sales of bit as about and congratulations and importantly, regarding an time? international the should world, it this a give talk when hear force in EU. approval? and taking the is regarding over thinking we color Can maybe How And ex-U.S. ex-EU? looks that?

Clay Siegall

much. the very So thanks for question

includes that So countries. program, And that in the we was the Switzerland have and FDA first – first U.S. and Orbis submitted that the thing and Canada. we through Singapore all, we and of Australia, did project

the one are Orbis countries are But the the others we U.S. which project of today, So launched is coming. in

and We way are approved these. in many its of on them in launches

we has – so Orbis excited that are project for really preparing are about launches And there. we

EU, will our It we we and are We regulators right very the there. organizations is the closely ex something well cover announced As who to the far and the commercial and U.S. this on Tuomo Committee lead it. top directly with as are working directly report of hiring Chip, Patsi, as who of in U.S. to will call will on incident, report the is me Executive Tuomo

experience. a the both both both our and and Chip Tuomo So committee, have on will globe cover tremendous Executive basically commercial for reporting and team

really to it future excited to our in our are we thinking So integrate make global plans.

way we are we’re what on you with the look And with when Europe, at well so our doing.

managers everywhere. all hired France, country Germany, have place, the We over

sure. for launch European for ready getting are We

we And And we’ve countries well Asia Asia, the generally, the what countries. Japan need in those. far heard small we the As in we’ve on to initiating exact exactly. you And so our need goes, already the as especially negotiated Asian we’re And to we bridging in countries, with many regulators Asia, these and from bridging China, some – have met studies. have others. and studies, big way

Europe, great project Asia. getting actually So we’ve Orbis approval with in gotten quite those And in launches. great progress made ready do to have few progress in a

in we’re really strong TUKYSA thinking a about So way internationally.

Reni Benjamin

the follow-up, terms how international there a if we force of I of should could numbers the Great. sales just people? the And is significant thinking be just for about expansion in sales, sales

Clay Siegall

salespeople, we many but in region at force point. a greater sales building are the this the how given of haven’t certainly specifics Europe We

haven’t so specifics given yet. we just And

that. to coming. closer tuned get give for give and more specifics we stay But we As things, Todd will financial to some that. will That’s guidance

Reni Benjamin

Terrific. Thanks and congratulations again

Operator

Sandler. Thank you Piper question we our will final take from Catanzaro Joe from

Joe Catanzaro

solid me Thanks on guys. yet in. quarter. Congrats sneaking for another Hey,

there And these EV cancer? Just Roger of and pace But a along whether of aided data of just you’re and the March. lines, is basket speak at a setting? could question degree any that wondering tumor this then dose-finding EV-XXX, on bladder EV in the any past in of trial that that’s pembro kicked consideration by to seeing, looking you I off if enrollment know strength

Clay Siegall

I address enrollment. could we’re could tell are should about little Sure. and talk Roger what Roger – bit a and this. enrolling Roger don’t you, trial low the I We thinking. talk we think about normally But

Roger Dansey

Sure.

generate we obviously, expression and other tumors. but sort passive potentially have ongoing. So so principles on high is another that data a of work give chance, to data, on EV but could is because is trial And or tumor. us real first active in cancer Nectin-X the the is There basket

partner drug in And again, lines, into line. strong with a talk Once so first inhibitor. development, from PD-X we in a we’ve of monotherapies, combination are ADCs later greatest really a sort particularly combinations, you think of from can’t obviously, found earlier principles actually a generally – and we detail. one But needs move

for basket that be of, to imagine one a find monotherapy, most we it the signal So would particular also tumor example, to develop inhibitor. go would for a trial the will fact combination and would a a combinations does that one and in we as PD-X look in obvious a

Joe Catanzaro

Perfect. Great, thanks.

Operator

like does remarks. that Pinkston you. any Thank to closing session. to over additional or question-and-answer conference Ms. I’d And for turn back our conclude the

Peggy Pinkston

operator afternoon. you, for this healthy everybody Good and Thank Okay. night. joining thanks Stay us and safe.

Operator

today’s you. for Thank conference. Thank participation. your does that conclude And you

You may now disconnect.

Seagen (SGEN) 31 Jul 202020 Q2 Earnings call transcript