SGEN - Earnings call transcript Q1 2020

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and welcome to the Seattle Genetics First Quarter 2020 Financial Results Conference Call. Today’s call is being recorded.

At this time I would like to turn the conference over to Ms. Peggy Pinkston, Vice President of Investor Relations. Please go ahead.

Peggy Pinkston

good and operator, you, afternoon, everyone. Thank to first quarter like welcome all Genetics Seattle to you XXXX of I’d conference call. With Vice Chief Siegall, Chip Dansey, me President and Officer. Chief Clay today Executive Chief Medical Romp, President-Commercial, Officer; Financial Executive Simpson, Todd and Roger are Officer;

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

open Following line for remarks, Instructions] we’ll the prepared our [Operator questions.

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

materially process. under ended faced More forecasting the COVID-XX company’s filed Actual expenses, a information cause with about or those to and year Genetics with such on projected these sales, impacts and in the annual include related XXXX. Form the that and results pharmaceutical differ approval the the implied caption Exchange periodic difficulty the report revenues development Factors may the or regulatory is for XX-K difference the developments reports company’s and Securities in from associated uncertainty forward-looking may pandemic in statements. Factors XX, uncertainties included Seattle by including Risk Commission, December the risks and contained

turn And to call now the I’ll Clay. over

Clay Siegall

afternoon focus significant team Genetics I’ve during made has and period Seattle remarkable and global good a our the and everyone. proud been extremely months. of individual Pegg past of over creativity impact. and few Thank our you, progress accomplishments of the

the PDUFA three cancer ADCETRIS across And we lymphoma emerging future approved today with a opportunities. breast quarter we we milestones significant pleased four date. best-in-class which announce first-in-class full portfolio, well are investing of and global of urothelial December brand was sales. are expansion and commercial as for for three as metastatic our These we and or remain broadened pipeline. important earlier these cancer, opportunities medicines of months PADCEV late programs metastatic patients. approval for cancer month our TUKYSA an includes are ahead first to stage for is this in in growth We excited strong received now earlier the

each I’ll with programs our some approved today begin comments on with of ADCETRIS. starting

to pleased in over $XXX net XX% of first the up XXXX. ADCETRIS We’re first of quarter report sales million of XXXX the quarter

range We to maintaining the of full XXXX sales are $XXX year guidance of ADCETRIS million our net million. $XXX in

ongoing a of partner cell chemotherapy Takeda, systemic Our the to adopted over the look-forward regulatory advancing We recommending opinion ADCETRIS trials. opportunities global from CHMP several and and authorization continues frontline ADCETRIS We for our clinical a believe in trials marketing are extension Takeda’s results based time. Most on planned of anaplastic positive Hodgkin make ADCETRIS+ range lymphoma recently ECHELON-X PTCL large progress. frontline settings. for in approvals to additional additional territory there for and

These cell and include for frontline large are combination B combinations novel who Hodgkin lymphoma unfit using relapsed/refractory chemotherapy, lymphoma. re-treatment, patients diffused

frontline year this further chemotherapy to in report progression positive regimen frontline data III/IV ECHELON-X of year We and free later both benefit results ECHELON-X from ADCETRIS+ Stage could approved These trials. lymphoma also long-term expect the five expressing the Hodgkin the survival and PTCL. in establish CDXX

ahead $XX U.S. In date. sales approved commercialization three in were months collaboration late of now PDUFA in in the its I’ll first quarter full the December, market, which XXXX, with PADCEV developing to million. move the Astellas. and PADCEV on we’re on PADCEV, net was

opportunities we’ve in month, PADCEV describe engagement. stages in to are of A in evaluating and bladder the to There of by initial pleased We’re the will earlier additional bladder ability PADCEV for cancer. line past reception end of as Roger to commercial mid-quarter the a as PADCEV metastatic that is urothelial patient well more we focus this invasive physician and progress primary team’s cancer our cancer as with In virtual muscle shift made detail. work important combination first KEYTRUDA. lines

patient in cancer, in recently trial basket first the beyond of Looking dosed evaluating tumors. range single-agent a was EV-XXX bladder the solid PADCEV

Our third name product the commercial and is for brand TUKYSA, newest tucatinib.

more treatment. pleased HER-X label with setting. metastatic with This combination regimens We’re HER-X capecitabine positions very including in based patients breast is one an the granted regimen the for trastuzumab by patients brain use second TUKYSA line whoever FDA. received for with option positive and with cancer in prior strong or anti approved the as metastatic metastasis, for

conducting launch the into option weeks by pleased the treatment to we’re new from for patients. this reception communication two channels. of which community virtual breast TUKYSA, almost through We’re the We’ve been cancer

To investing maximize a HER-X we’re development program cancers. TUKYSA, potential of positive in broad across the

we’re ex-U.S. of potential preparing of and addition, operations commercial major European ahead In approvals managers general in European for hire markets TUKYSA.

Vedotin Turning or we or TV Genmab. now which readout Tisotumab on with a collaboration in are horizon out trial pipeline developing is clinical the with

We’re simulation and of conducting no single-arm trial with poor. or care women there cervical Phase recurrent metastatic pivotal are is where in a X outcomes standard cancer

expect report quarter. third top into line or We quarter to results late this the

just clinical and It ADCs are to early been targeted Vedotin, receptors widely submitted. expressed stage is Ladiratuzumab pipeline includes are robust. ADCs tumors. SGN-CDXXX SGN-BXA solid for Our an IND all These in which as such that has three

the CDXX annual compared research the that on of tolerability knowledge June. AACR with potential on to this and anti-CDXX several presented our ADC in data has improved expertise will deep for ADCETRIS. Preclinical SGN-CDXXC be CDXX enhanced meeting our with SGN-CDXXC. along advancing candidate virtual abstracts activity a novel at other our called is expressing upon This malignancies ADCs, we’re directed IND and year expand To another

clinical progress novel early These in with immunotherapy agents our In addition pipeline. we’ve SEA-CDXX to SGN-TGT. stage include and ADCs, made

the in ownership be cancer and the from was process to our arbitration. arbitration and through federal prevent other resolved wanted with drug revenues that used of should growing dispute our commercial to ruled cancer XX, We court. that I going Daiichi actions our move Lastly, candidates. regarding our this Sankyo on are we trying dispute and and diverse certain arbitration With portfolio, April provide to been an forward. multiple in be opportunities this technology a a range arbitration agreement, type through to should dispute provide of for in According Daiichi dispute development. breast of HER-X, Sankyo product On update future. should as programs that resolved it positive the types significant view in the well-positioned has

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

Chip Romp

in activities. the in sales driven UCL. in on and growth you frontline quarter Canada ADCETRIS indications Thanks, Hodgkin net the Clay. U.S. I’m excited commercial to update first were and our our lymphoma by

the resonate data physicians to later been to Five ECHELON-X from of believe should with AVD five-year year for setting. As ALCL. the with who’ve Clay we mentioned, we ADCETRIS trial. care this data slow are become adopt an some patients the frontline that look will PFS year the PTCL, in established forward standard ADCETRIS+ standard In

CDXX areas increase in our of One subtypes. additional for to focus expressing XXXX use is in

first In were to launch, Now I’d million. net $XX full like since quarter transition sales the PADCEV. to

in these the We uptake, with results strong early are pleased and with particularly community very setting. the

hard to treatment or our with and awareness PADCEV to platinum for We to new momentum. seeking Astellas our and goal important are therapy. patients, is understanding metastatic Along still drive strong and into and early our support maintain the are this urothelial treatment of our colleagues, PD-X with launch after customers option working PD-LX we

our complete. dedicated materials for and And were comprised rapid was the team of finally Physician was virtual customers. and the networks teams is is accounts look and up in salesforce approval TUKYSA the were high very in TUKYSA to ready our and our TUKYSA, product is good approval, reporting beginning breast the access field day are product our forward order. to specialist progress third trained in Interest distribution marketing calls. you the sales cancer patient updating websites future commercial ready. of to available I and on are

Todd. call Now over to the turn I’ll

Todd Simpson

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

of a strong comment reflect sales. our first the quarter remainder the the I’ll financial Today the for Our progress our across significant XXXX. results quarter then results and quarter business, first outlook for PADCEV first on including of for summarize

million $XXX $XXX million included PADCEV of net and net $XX of sales this of XXXX, sales first million. were ADCETRIS the revenues Total quarter in

co-promote compared lesser the by last were ADCETRIS to million of on of sales first sales Takeda reminder, in we quarter million a As year. a Collaboration of Astellas. Polivy to the revenues by Royalty of compared in our to in the the with XXX% growth revenues XXXX the primarily record first quarter under $XX in U.S. now degree XXXX. $XX Roche. first of $XX of and This first PADCEV reflects $XX sales in million quarter quarter XXXX of million to increased royalties

from ADCETRIS in is Takeda of decrease $XX EU result The That of approval a revenues earned milestone year. last triggered was in lymphoma. the collaboration Hodgkin by million the frontline for the

of Cost that Astellas second Beginning of quarter. both $XX was million in-process quarter sales will future That cost part also on of further provide the we’ll on was calls. include Cascadian We the in now including to to and the increased quarter, sales amortization reflects $XX of of non-cash guidance acquisition. of to the million share reflect ADCETRIS plan cost for and R&D. PADCEV in acquired also XXXX the TUKYSA first sales profit first PADCEV the and

across quarter of pipeline. XXXX, in over million our reflects $XXX were investment expenses first growth R&D higher the XXXX

SG&A of $XXX to in launches XXXX. million The reflects over the increase in were commercialization TUKYSA. expenses PADCEV of quarter efforts first the related XXXX

with We million and ended investments. the first quarter in cash $XXX

remaining common $XXX investment which in our in These addition, cash that for are of mark-to-market overall the to first $XXX In of approximately Immunomedics a the we We quarter. at end held in quarter. of million. contributed million $XX April, million monetize the the loss non-cash stock an generated investment which shares loss of portion resulted

also We acquired our $XXX sales year back including million. and this XXXX when prior gain investment total was in

from now in is financial providing XXXX, February. product this guidance and not for outlook our all our sales At guidance brands. three will PADCEV our ADCETRIS include provided expectations we’re TUKYSA or unchanged for point Regarding

TUKYSA trials R&D increase expect expenses to We as ramp PADCEV of in up.

launches is by U.S. the XXXX and in growth expense SG&A PADCEV driven TUKYSA. both of primarily

R&D SG&A for remains guidance unchanged. Our expenses and

Lastly, the COVID-XX our impact business. on we continue to closely of monitor

our employees, to advance to trial safety while continue supply of We also have mitigate patients, and implemented the and disruptions a efforts professionals, chain include clinical healthcare steps number health commercial of to and These measures protect our our operations. taking and activities. to

with our in of critical treatment. support To-date, our the ability of need for continuity patients business and the to we’re cancer pleased

environment time. that has dynamic COVID-XX the a company over However, may created impact

We will going keep investors updated forward. as appropriate

that, over to I’ll now Roger. the With turn call

Roger Dansey

expressed and our of programs. in and bladder today directed we’re our I’m on ubiquitously activities I’ll clinical pleased therapeutic undertaking everyone. Nectin-X, and with regulatory our good ADC potential afternoon, Todd, update development work cancer. start Thanks, the which the PADCEV, maximize to against you is to

data As PD-X from inhibitor. the metastatic cohort know, you and PD-LX approval following cancer trial of with of a PADCEV in platinum-containing treatments supported urothelial EV-XXX the the first patients regimen or

second month, survival. this second but could ongoing patients which indication enrollment is with this for of are randomized endpoint the or PD-X earlier urothelial EV-XXX Phase XXX believe second evaluating cohort X cisplatin. is and we following year Other potentially for of completed cancer. of the the data monotherapy patients patients PADCEV. primary from support overall we inhibitor a we for the who key advanced eligible activity PADCEV was were completed in We Enrollment not PD-LX trial in received or treatment Earlier EV-XXX the cohort

global PADCEV the support first we who updated another metastatic and cancer meeting to were and intended At approval. GU urothelial as EV-XXX in is combination XX cancer confirmatory for for of metastatic patients KEYTRUDA key applications previously from is study reported untreated results serve chemotherapy. EV-XXX ASCO the line cisplatin-based regulatory EV-XXX in urothelial trial ineligible February, effort. a with in for

median PADCEV hyperglycemia, BGD. response combination in rate the designation the XX response is Median not KEYTRUDA combination data neuropathy, This individual safety was PADCEV profile was reached. from appeared survival progression the reached. in median The The duration peripheral and breakthrough was free of [ph] and not rash, with our components with and including for supported overall setting. therapy had objective FDA been consistent survival of XX% immune-mediated second These months events.

Based approval on ineligible that are discussion now in pleased line with PADCEV cisplatin has we accelerated the disease. EV-XXX first the support metastatic and potential for FDA, to

trial. serves response. randomized which either by PADCEV XXX The to alone. In January, pathway enroll patients would of response the trial that Phase This KEYTRUDA receive to complimentary confirmatory is cohort objective rates endpoint potential to also KEYTRUDA a randomized primary plus added intended we support registrations now or accelerated PADCEV as duration X global trial EV-XXX supported and is will be

are Merck, we alone. cisplatin PADCEV includes patient importantly without Target ineligible and primary or evaluating are The chemotherapy is are we progression-free evaluating this in with treated enrollment trial KEYTRUDA compared and or chemotherapy and and of that dual of they to is announcing with we eligible Today, and EV-XXX. have X,XXX PD-LX combination patients the In all patients together the Astellas trial overall expression. whether irrespective survival. endpoints first

agreement early in and cancer, Merck KEYTRUDA and cancer evaluate Seattle an will bladder trial a we bladder under clinical In PADCEV Genetics, recently Astellas muscle arm to an ongoing Merck completed which by trial. continue of the providing to this adding in are operationalize Phase and the study. agreement, PADCEV/KEYTRUDA Under will expedites combination This X this the setting. and registrational we fund Merck PADCEV invasive development

HERX. move TUKYSA, kinase I’ll approved on targets that tyrosine to recently our now oral inhibitor

approval At the and analysis FDA at that observed HERX trial will activity brain the establishes is to in patients Scientific the the in with brain. the TKI. further in seen effects FDA Virtual we Program HERXCLIMB which treatment in believe received under metastases TUKYSA best-in-class a ASCO May We the late review. we by of demonstrate TUKYSA on pleased the the very We’re present as HERXCLIMB speed oncology realtime label

for data the oral will which was an presentation into of aspect insights more provide selected The this trial.

ongoing Canada review Orbis Australia, under as marketing with Switzerland, HERXCLIMB and currently in that the Project and EU. Singapore, Our applications in of regulatory also part efforts are include

metastatic evaluating We in cancer with combination T-DMX persons trial randomized TUKYSA versus alone called T-DMX brain are including metastases. a in also with HERXCLIMB-XX X Phase in breast

development that’s previously and trastuzumab metastatic adjuvant a taxane the represent important population Both successful, have TUKYSA and line for or receiving in is must and line a of of beyond it the first the received our second key part first metastatic treatment and combination support patients positive TUKYSA thus use trial, or the program. neoadjuvant, remains will this the In HERXCLIMB-XX drugs in if setting are current expanding setting HERX and HERXCLIMB-XX treatment. breast of T-DMX label. cancer

In key mets, these activity survival survival outcomes improve patients. given secondary HERXCLIMB-XX mets. ongoing may PFS patients brain patients. endpoint with demonstrated free the target of also and addition, progression The with overall TUKYSA endpoints a and is XXX brain of with primary and combination the Enrollment in in patients is for of

efforts in HERX metastatic cancer, gastric we the on our previously cancer Trials and TUKYSA, are adjuvant are Lastly cancers breast continuing. and outlined colorectal plans planning amplified in neoadjuvant or and breast those phase. and mutant cancer cancer

in turn evaluate trial. with I’ll new clinical this We combination recently to Next, the of two stage early effort two and ADCETRIS. our of lymphoma. expanded and The stage This combination together the assess active brings the plus collaboration Bristol-Myers ongoing will clinical Squibb Opdivo further focus most of ADCETRIS lymphoma. one an in be approach in agents Hodgkin chemotherapy to Hodgkin to

regimen. toxicity Our goal efficacy of the by components is to reducing improve the while limiting chemotherapy

turn call I’ll Now, to the over back Clay.

Clay Siegall

Roger. Thanks,

our care first clinical PTCL continue oncology lymphoma Hodgkin establish upcoming standard as Before across of activities ADCETRIS we in to open They frontline and for frontline portfolio. additional to I want and line initiate key questions, recap the trials. include

strong development Second, bladder in launch including with Astellas cancer. continue PADCEV and and advanced program muscle broad in invasive trials U.S. firstline metastatic our the

to year. continue continuing following development And the into FDA We our pivotal results cervical of TV report cancer. Third, and trial robust look the TUKYSA to approval advance the launch top remainder from recent forward fourth in clinical line its momentum the program.

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

Operator

take Sachs. with [Operator we Goldman first And Salveen you. Thank question from our Instructions] will Richter

Salveen Richter

the how a to been Board? PADCEV rapid the Thank maybe that on of trajectory the And on drivers comment has launch. and the XQ? key you was think PADCEV launch can should there we Thank care uptake on about part just in whether you you. the as and congratulations for What patients for bolus

Clay Siegall

the question. Yes. Salveen, thank you very for much

can’t community We’re this our I uptake that the of see on was sites point, demand including PADCEV accumulating pent-up And that delighted as and see other and it’s things or $XX with that really first exceeding on. to we way our mentioned or whether the had sales was it’s million. inventory along quarter at there We hard was full look sites, like early good, that. setting. previously in the really that at are that But really calls expectations mentioned

it’s right that see disease of So for This drug very important didn’t an that have to now. hard a lot therapy. is really good

And so PADCEV to there and I Chip, a think to add want didn’t do we’re helping mention? in you anything I patients big way. that

Chip Romp

generally don’t just-in-time sites include significant kind inventory inventory. We or Clay. is Sure, a model. Yes. accumulated see significant delivery of This

they’re ordering, patient. when generally they have a So

advancement, this saying good I and I cancer a alternatives marketplace. think, the think wasn’t an right treatment that there bladder out just represents in in that you’re for

Salveen Richter

Thank you.

Operator

take We’ll Markets. MacKay Kennen with RBC our from next Capital question

Kennen MacKay

you bullish the launch congrats on for even global Thank so as much let estimate question and pandemic offer a my very me incredible the well, PADCEV ongoing. taking very a despite

So a congrats huge huge, there.

has been a So discussed little bit. PADCEV

little bit a going I impacted or you’re due readout ask in ADCETRIS a It was like it maybe use been fully impact back seeing the the like around So have then tisotumab little given of seems maybe seems March was COVID trial also, QX what got this pushed was and to enrolled. bit, might in wondering the vedotin I elsewhere. to pandemic. it

response again. that is we should patients maybe congrats I’m an collection much that that’s from are so suggesting of progression-free you Thank be wondering if that ongoing thinking longer trial. in survival these some scan and

Clay Siegall

you. Thank

with patients to. tens a really great And drug. of continues excited of ADCETRIS, it’s It’s we’re ADCETRIS. and helped So about thousands

quarter a out. it up. little from first hit the that been two year time is bit sales year. XXXX, with light ever the doubled ADCETRIS, has and year always have last in it was quarter $X And drug Sales billion And first XX% in was globally this years. The past over

at look quarter. I year’s quarter the So first over

Now something hard did get could that, well patients are be having happening. to is And COVID-XX. bring that really it’s unable that and said for a there’s number small a to – very look know certainly, therapy that It’s up of something you in Whether at. come is to lymphoma exactly.

we’re really something year. guidance But it’s our our for the that about out excited we year. this changed coming later haven’t five-year data And

So something to really important I that’s think look at. that

to registerable. briefly is snuck most on with thing second with that a timing. we And question need you important The is potentially in TV our data Now TV data the about this type the third-party the data of and these reveal present work data puts this duration the we blinded and and together follow and a that with of before data. can follow

something that’s ongoing. that’s So

possible. We’re working we’re that may We little bit the case this third happen. hard working come working toward If okay, they slip just out the in at. that but very make trying just time in this put well to frame into it does hard we’re may to it quarter, quarter, soonest done a and get

So read you too soon. I will it into much wouldn’t And hear it. about

Kennen MacKay

Thank you.

Operator

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

Unidentified Analyst

This Hey, eligible? docs front? just could this? you EV, of patients expect few the can from also on access that the we’ve thanks are study co-pays are undertaking your EV-XXX for on now this when TUKYSA, for Thanks. be from programs you’re a on taking on for On on curious on my And to we from I’m that And barrier based heard patients platinum for right data thoughts some then some Turner is What [ph] administered Cory. orally other a could pharmacy products. question. experience comment

Clay Siegall

EV-XXX you It a was hard little trial. did question it. You Roger, the hear for question? me on to capture a asked

Roger Dansey

for I question. And I did. thanks did. Yes, the

Clay Siegall

then do the we’ll Chip. with data question And go can and first, back TUKYSA you to

Roger Dansey

I can that. Sure. Sure. do

to the we expect PADCEV cohort metastatic The from frontline that a was, to the trial in question potential cisplatin is, the January. would randomization bladder enrolled It’s monotherapy So is data expect. XXX. enrollment lead the KEYTRUDA. The approval And versus number a in answer going started XXX cancer. as would total is we eligible we plus when PADCEV

can’t We and that that. need. rates the reveal are two of point – of to response the we the timing are response we But not duration out just endpoints

what can’t point. fully we reveal look we that enrolled will this we just understand, once at like. timing that So But

Clay Siegall

can TUKYSA about happen. that you Turner hard worked any not very to and Chip, on copay comment And heard had barrier? Okay. make the to and potential We

you about for Chip, our So talk can doing systems that?

Chip Romp

order already provide the our insured patients of with associated Through to Clay. product. program, costs established with out commercially will minimize copay to Secure pocket we eligible assistance SeaGen Sure, for help in

Unidentified Analyst

Thanks. Great.

Operator

We will Morgan Harrison from with our Matthew take next Stanley. question

Unidentified Analyst

[Indiscernible] on for the question. taking Matthew. for Thanks

your just and you. discussions And Thank launch, there. seeing may have Can and conversations how you FDA So they the of sort with COVID the on those then frontline? penetration approval and I been quickly accelerated PADCEV. impact on going guys elaborate just what guess bit you on the thus the And how the far? been in timeline a on have

Clay Siegall

Matthew, and second, so multimedia to my briefly? time one a for this your just this. can doing am through phone you apologize I sorry two way – cut questions Can of for I more you ask out you go

Unidentified Analyst

Yes. Sure.

my Sorry. might be It as end well.

accelerated quarter? you approval those just So potentially penetration you regarding PADCEV the during briefly the that seen provide going and first And launch of some it’s how frontline could if you could and FDA discussions on I guess, had what And just available. COVID your the sort then PADCEV? to have elaborate on guys the may and for then that impact with timelines commentary just

Clay Siegall

Okay.

an all for patients So, the just Roger on gave XXX PADCEV first frontline doing the the we’re of accelerated in work update approach.

patients two We in so each, XX enrollment It’s his he in XXX it’s arms the And well. the prepared going remarks, January. started explained patients.

of the at done drugs. a different and have with lot think, this the our – put timelines we a We strong out not day end but point, was on at this release press we’ve I provided it. the interaction FDA We with set

looks it’s making data But data. at the what and we’re decision eight to based always FDA. on this labels decision. think have we know a The the with your day, review at end different to we pretty and need FDA drugs and the approvals We I at the and of good bring

as be not get work we’ll forward timelines, bring FDA. yet. it prepared we provide trials, the and we we’ll And we the but into So to usually further fast, will

wasn’t can’t actually field as far As virtual then which our and months two approval an train us Salesforce, fully two COVID-XX impossible We out. that hit for four months apart. on to It’s help and there to TUKYSA. COVID-XX and COVID-XX. We impact out in rule to the drugs that rule be a salespeople PADCEV, ready getting switch we had had

So drug we it have with the is – second doctors, had as, far impact. caregivers. TUKYSA virtual rule but to as cetera a and et that communications purely while But with can’t PADCEV, out

with the we’ve It We’re out very pleased good got really $XX are it. net a drug. and using patients, there things million We doctors of hear the sales. in means really about gone lot to we’ve

We’re future would we also in provide line would and like we not on of forward are in that setting yet. market but certainly PADCEV as have we have, these only the other settings provided not bullish the decide of These in number first a type or whether we things on going relapse and this not penetration guidance.

Unidentified Analyst

Thank Understood. you.

Operator

our will question Schmidt We next Michael with from Guggenheim. take

Michael Schmidt

to Merck cancer? collaboration look you like? just potential big you market what here might that be cohort muscle well Hey on here opportunities. can incremental how terrific help and mentioned then guys. for my PADCEV. path questions bladder additional couple Can Maybe congrats two, cancer additional understand labeling us The could launch just bladder the Roger for a Thanks the And patients. the as for you on help taking invasive in opportunity just us as EV-XXX

Clay Siegall

go Sure. on ahead. Roger,

Roger Dansey

Sure. Thanks for the question.

platinum Cohort seen a we’ve broader it’s a have as patients enrolled group high inhibitor PDL-X but than meaningful So, that’s meaningful unmet Nevertheless, this cisplatin a – population a on are the seen two. PD-X not population, we’ve two indicated, population. or is eligible It’s PD-X. have cohort EV-XXX smaller And have who it’s the need. trial of which eligible. a a

followed data timing. overall and evaluation. give we’re an So duration able completed We’ve bit little around It’s more one. of cohort a cohort is one you as by matures as we’re This is enrollment. to guidance – response response was the as hopeful

get on So, guidance. we’re year. more the as we’ll later hoping But I you the results, get we clarity give we’ll potentially think timing, this more

very invasive With cancer, bladder we regard to are muscle pleased.

one invasive leapfrogged, Merck PADCEV in As you patients in our approval cohorts an of running know, have looking by being potential at ineligible to bladder muscle registrational to join and cisplatin very EV-XXX, KEYTRUDA PADCEV in with group of the get trial, able cancer other looking we’re important we the two this and together essentially patients. with at sort monotherapy

The endpoints and as focused like things by, original response defined the Merck complete negotiations pathologic survival. between event-free on and FDA

which the some available through details and means. more trial is how once PADCEV been an detail become altered ct.gov will to for I think But trial accommodate that KEYTRUDA has we’ll into available other or think of And go are ongoing I you. we they’re joining. that publicly,

Michael Schmidt

it thanks Great, for the information. Really appreciate and congrats again.

Operator

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

Greg Harrison

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

into you some it across showed little board that the definitely Just to confidence. more, guidance the a the maintained dig fact

terms other negative know So items? your two or expenses just and as ADCETRIS what the give as implied you wondering what factors in impact outlook, is of guidance and guidance your in decision well are both play, from in to confidence COVID-XX maintain that that positive in

Clay Siegall

the Sure. It’s address let I will ADCETRIS. a expenses. address XXXX. in ADCETRIS been great the Todd is product. out approved And there,

We helps ways. labels many different have and patients in six

that some really I that – scene, a rely and comes was think benefit patients changes happened really rapidly. on to it, on I think it doctors docs COVID And by little so to exactly the onto what for the we and came from depend when know out So were out we all do, hard, it. and it, stunned first patients bit

important when I so important. they it think is is but that really therapy, for getting getting and really, continue for as cancer, to really need it therapy clear, And initially not these it was patients therapy

learned wear and more that, and masks bit learned things. So other I do safe stay and over little think how a time to we’ve

think and so through that right disease. with that And we for patients are I now, the threatening really and life And is cancer improving cancer which years. important getting see patients strengthening therapy

guidance patients we our because want think a expenses? going you their with for to need that lot staying therapy. they’re I makes So of do therapy are think largely us that about and be there talk to Todd, getting sense

Todd Simpson

commercially, by perspective, an disruption we’re done from first right. looking business and at have to of doing best and trial we trials saying we interruption really, I’ll patients on what keep management to on off team, are we what clinical we’re start the our Yes. the maybe cancer Clay absolute When look can have you Clay. focus at level is that tried important a this down. as to a to minimum, keep really trials our

look our R&D expenses when below you we’re annual in the if Now, annualize guidance. our first quarter, that, little bit a you at

But to The we really trial, got we TUKYSA still forward are out registration bunch and the of responsibly. trial pivotal can include best combination that can. of trying This whole XXX underway XXX as a fast that that the MOUNTAINEER we’re to point going and studies can trials TDM-X TV and we keep as I would we in the now best and as trials ramp got the it keep for potentially sort the moving with up a study. done We’ve EV. lot mode the of we’ve XXX, doing

Greg Harrison

Thank helpful. you. very That’s

Operator

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

Chad Messer

me let least. get quarters this few full Thanks first think And rate I taking expected we run strong for on a for Great. my don’t to question. congratulations you at to for my add another PADCEV. really quarter

on is expression. Nectin-X question My

on cancer of enrolling it you expression and so presumably that of any cancers, it’s and more in how sort in collecting other it’s So of correlates but information are quite response Nectin-X important these based ubiquitous, not urothelial studies because on as that see and where how your that, so looking is you to of the some studies any you’re were other ubiquitous outside trial. basket look kind to indications watering urothelial where Thanks. maybe you I’m going becomes in handling not

Clay Siegall

there for tells factors. we how a much I other in we product turn very over Phase about lot make on, ago I’ll X, this you Yes. a is talk and rate. started mean response quick to But were and years looking at to Roger, H scores, it napkin of looked comment early which when

Nectin-X, way mind a And keep is Now and pretty it’s kind bladder scores it’s but in It’s it XXX% is a readily of not it’s determine quick ubiquitous precise, in to of cancer. and forth. crude good. that are, and available level H

very on found see correlation response. we the score was a so it histology And H for hard that early between the to pretty to the

that basket the metastatic in in setting. there cetera. So need in other regard, thing about do it we let a And speak tool from diagnostic Roger trial, the I’ll for any et not

Roger Dansey

great a question. it’s Yeah,

tumors. obviously all our really of we expressing highest So the for ADCs, look for

EV-XXX trial breast, of high expression. basket gastric has cancer and group the always neck, a so sun, head, Nectin-X cancers, we as lung, And prepared. which are But

actually biomarker Nectin-X it always that would be respond, relevant was is who potentially ready if for expression we think I turned would that. out measured. a selecting So And in patients

it doesn’t be next do. Our door that supposition biomarker. [indiscernible] is There it, that case. going effect not that not will leak with have be need we get, prepared into but in will will ADCs if the so particular the drug isn’t, mark But, components, cell we premises, we are example, a can a bystander can for

Chad Messer

Thanks. Great. Okay.

Operator

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

Gena Wang

questions. Thank questions. my for of you the taking Two parts

one question my arbitration the the regarding first regarding process. revenue second PADCEV, through wondering, or driven is scripts doctors? First just academic IT strong I’m mainly the by was doctors that quarter the community the with is by Well,

will long usually how it and wondering of the multiple Just there will be process. it take rounds

Clay Siegall

what in is all, planning we settings. and of what this are percentage settings point at percentage concerning in not first academic outline is community So PADCEV, to

fair mentioned which the community we’re in think delighted of amount Chip I coming is from with. a that the settings, use prepared remarks

academic great So doctors we we in out having we’re to forward the from settings look they PADCEV this use patient script and and to community as benefit pleased very now, and the and with uptake patients of that a year doctors and can both in see right the need coming supporting drug. providing PADCEV of to exciting really

in and be we’re discuss Maybe it’s to we’ll to academics the think and but too So position really future to soon that. entirely a settings, the about speculate community that’s going something continue. in

– is the ask as believe, you you correct we we about that? that you Daiichi far Gena, do in litigation, asked what discussed what did As question I meant, a Sankyo

Gena Wang

yes. Yes,

multiple is expect read just be wondering, I long – would arbitration rounds? results not usually we would be should process that final be the how the know certain is take? there And there So that also, like but time wondering will would process, just a it’s frame, court the out?

Clay Siegall

Okay.

So we very specific are for not to timeframe much. any guiding that. appreciate I question the

the was was the was the forward has issue that Daiichi had we basically we approach pleased did arbitration. if what arbitration. in like the go mind pathway based deal there that forward through come said Sankyo and correct We ruling legal Keeping go an up, on that’s right are with deal that to that to the the

strong, we is our made appropriate. IP publicly before. in And have. And they and technology which We forward mentioned to this they they case our that improvements, and very believe out spelled products are the believe this in agreement protecting correct believe completely used our as bringing we was we case we that the

feel we So very strong that. about

rapid more in resolution it’s case. to Going court is a rather it forward than a forward and to path a arbitration bringing efficient

And going very but make and that’s other is that we’re can’t started. pleased that now through matter comments. a legal pending it’s we and arbitration And so than really

Gena Wang

Thank Okay. you.

Operator

with question Piper Joe take Jaffray. will next our from Catanzaro We

Joe Catanzaro

PADCEV question Thanks Hey guys. on taking quarter. nice for here and my congrats this

four, with in question thing give a to with around out of advocacy tolerability. they balanced and given every is felt heard dosed it’s three the PADCEV some prior they try COVID had physicians and dosed it, trajectory how one real we that weeks One the setting, Just just flexibility us in a of world had sense moving forward. the maybe its even

pick to wondering that early of whether here. patient of sort seeing any environment Just if maybe treatment, you’re expect of duration And the and Thanks. though up maybe visits. you to current light it’s in that minimize sort realize around of sense

Clay Siegall

on to we schedule. other one really you’re mean, exciting weeks haven’t I we’ve, talking proud some so very drug. can and and Joe, our have drug flexing great and duration Roger to it haven’t it’s we turn three comment I data but doctors So, holiday that presented our schedule. of all seen data we’re about. seen duration to and what on that’s this, on over we a and schedules week of firm done that The with some we holiday, also, our

is Roger, I want anything to there mean, that? add to you

Roger Dansey

Yes, sure.

you cancer devastated when plan be get get can think the bladder I devastating, is cancer with demand are treatment medicine into high. patients the which is – symptomatic So very and a to per the disease like

onset oncology some what sort may schedule could like through of it clinics COVID taken how to get initial to of for how the and work out time to a treatment. new have With manage patients look

on, visits is think struggle focus So most clinics that with treatment that they I of focus on so aware getting paramount. the is treatment may of we’re the treatment, giving and the off but

Joe Catanzaro

my Okay. for Thanks taking question.

Operator

Andrew We will Berens take SVB. our next question with from

Andrew Berens

my let was And beat we add me a yesterday. on Thanks. you that thought the congrats guys and launch n launch, HER-X the number great strong

drops duration mean, more being usage of of wanted they’re and advanced color seen beat as the the Just early roar the one the advanced. that I off, gate and but to guess you’ll of I launches patients then parts. it’s by on of more three that think get for driven because some eventually more PADCEV we’ve get, kind question, really we Should patients uses other out then

us or with the that are see usage the FGFR case you PADCEV seeing be then Just are And if here? can last you KEYTRUDA? can patients part is, color biomarker? to trying the then that you any have And guys give getting of

Clay Siegall

you on three Thank you questions congratulations And innovative. very into your one, questions. putting to that’s for

feel seeing broadly feel are. used and So lot will your we’ll the being see that not to We be fall go, advanced a we on and continue patients used is this is and that stuff, of as advanced whether as we’re far patients comments a off broadly. all we where

– We a metastatic advanced, less they’re some advanced I cancer And that in type for the make anybody, And forward. this have I don’t don’t excitement happening. going to or in has are extent with you’re advanced, a that for really lot all I that seeing earlier keep disease. of most in there’s anybody whether according to the can’t benefit. lot bladder patient. And treats or patients them of think that can cancer think drug that’s cycle a it’s whether – we’re of later I mind one comments label, more bladder cycle advanced, just bad this

data. KEYTRUDA, far loved As as our we the combination with

line for also which Our is there to we say data frontline, early combination is FDA, with which to to spectacular KEYTRUDA. in with we global went expedited pathway a was why that, is why look first started an get to trial to

full trial as expedited global both well doing we’re doing the PADCEV. the So with as trial

there PADCEV we comments as make can’t using combination any that, is not, far promoting whether as for. that’s And we’re not on certainly something anybody KEYTRUDA with that out

encouraging We clinical trials do we’re right trials open have to for to I now up think that, sign people that.

just working And should decisions. We doctors possibly that their many can have that of I make that’s so And as with no I subsection at we everyone, cancer. say. tool. as should out as question We as we’re focused we’re that. a not we something aware It’s very really helping though. bladder treat we’re diagnostic use can looking last everybody, basically FGFR the far on and of on mean, biomarker, patients therapy – small there’s no the

Andrew Berens

very Right. much, Clay. Thank you

Operator

We will Stephen question Willey from take next with Stifel. our

Stephen Willey

launch. on Yes. Thank you congrats PADCEV for taking the question that and

was Just results if linker? terms a the any opening in works little the stable thus drive of ones, could regarding maybe there’s in just bit Is then was for to that remarks. what’s we’ve in that And Is the used of improved talk in CD-XXC if tolerability about couple you curious there being a of your different referenced more quick payload? terms far. that publication wondering, just seen EV-XXX preliminary plans, the a that Thanks. a data the

Clay Siegall

target of and CDXX a best for can cancer know that that. something is we And we is presentations, With decided opine and whatever. question as on for to it lot drugs to can CD-XXC make CD-XXC was as that to plans innovate have the continue to the of studied we then continue Roger we years. heck answer publications, patients. This and try I’ll of a a Sure. for EV-XXX important

the company the about of top CDXX if one we’re think the not companies, thinking world I top therapies. in

continue improve patients is for to to CDXX ADCETRIS better, And so try that about patients with is I a drug, to get but important really think important better malignancies to outcomes think and phenomenal it’s treat us. you for can

lot tells a get versions different we and and say I that of just make a patients ADCETRIS, and try is. really better drug a outcomes ago ADCETRIS. even good we And, of a you can a which even can So hard. few couldn’t we years than how lot made set drug a already to good years better give what’s and it was for out ADCETRIS mean, any about drug it how than

payloads, it’s different So It what say different ways different different. it CD-XXC, to I different has linkers, is would combine with work, with things. it’s going ways could

so work really can to this about. patients, and much do to forward bring talk setting whether of see in than excited and what different know the characteristics, it. EV-XXX In be yet. this animal will models cancer, really with prove helping want plans? that’s we’re with we to better and clinic, But different laboratory about how the ADCETRIS we’re we So you don’t ADCETRIS excited than that’s toward or Roger,

Roger Dansey

Sure. Yes.

think it’s a a question as and that call. were results know, remarkable update you, been it but make if publication, made, think potentially be final the really a consideration, don’t obviously has worthy and quite we’ll great could decision that we I because you we So it’s under but of

Stephen Willey

for Thanks taking the Alright. questions.

Operator

BMO next Capital our from question take George will with Market. Farmer We

George Farmer

question Hi, mentioned do that? good to you needle afternoon to and ADCETRIS. with congratulations there’s some move to coming. on And had see, Do PADCEV. be the you you that’s data Clay, if fantastic so, And five-year a follow-up see actually going how expect It’s about going I practitioners? that

Clay Siegall

approval they docs really for using question. data. a and first years And And to the Thank two and worth call George. lot this. a is of know data saw a had our they the of rate. were in got the it lot It’s remarked and and standard good strong, to gold and data was that it and data this data five-year we wanted Hodgkin was of long-term know treat question, When docs were we really for a to the the frontline they the how you lymphoma, ABVD cure the decades saw five-year data said what’s us they but for the durable started they disease see

so you but mean have I disease, something, of free, we sure. out, no evidence of because die and you’re talk are say are someday disease five-years defined technically all we no cure, this and five-years of if you out have evidence you to doctors cancer, they will cure Now patients your cured their for a

considering that But the I be not the it important. for they’ve on as always or I guiding we’re that fence think that, said or something, George. gold interesting rush think And it, could the five-year could five-year be still not to I But that certainly number anybody be standard. the us that is mad whether data absolutely to think a it’ll

without the during especially having COVID is, era we’re thing living data other important. bleomycin The regimen a with is five-year in,

get then I’ve to scarring And a respiratory in toxicity, worse distress. but for that have of Hodgkin be I because severe have to much would much, circumstances lung many lung to get pretty COVID, causes and that you respiratory to and you not scarring be distress with patient the gives and curable disease bleomycin. it exposed a want could because is lung lymphoma, some said, the the you somebody definition give which them by Bleomycin

an having the four-year survival higher COVID we thing the ABVD I is by over – about data in have four-year this to this and having even we’ve, the without working five-year presented around far so that data, disease lung we important better. think era through of in would be are and think bleomycin, is scarring X% to that higher a rate So rate X% a not a free of of data better, you alternative only

George Farmer

kinds detail? that makes talk a discussing at presentation finally little in Yes, what sense. two bit can about be ASCO more the you will And of then

Clay Siegall

Roger, the you we whole a can Well, that’s because foreshadowing? But meeting. virtual give tell for the little can’t presentation, you ASCO

Roger Dansey

Sure.

survival the with and focused and metastases, important survival free it on that’s the can was free the which then which data in were in under designed and to benefit population, presented, So and brain as questions overall but outcome you on as questions progression the overall and was we’re points brain patients survival value the progression itself. really answered HERXCLIMB understand main But patients. important the the in interrogating the focusing be framework by still end

brain hope what what those will And put to we and the more we ASCO. like. value presented together specific And outcomes a so gets look to be story coherent explain, is when at that’s we’ve done everyone analyses think we’ve a will it what clearly

George Farmer

Okay. Thanks very much.

Operator

next from with our William take Andy will Hsieh question We Blair.

Andy Hsieh

taking hope for congratulations staying everybody safe quarter. I my spectacular a Thanks and Great. is and on question. healthy

pivotal question EV-XXX concurrent enrollment patient do of my very the to kind cohort So similar population. EV-XXX the with K has and the of

Now should of we do are really given the towards that enrollment which see timeframe. EV-XXX, therefore kind K, options expect chemotherapy those you tilt cohort have a free you versus and rapid enrollment

Clay Siegall

and the the there and geographies, et pivotal what So cetera? thanks can the for the trials. we’re you question on cohort of looking explain thinking K Roger, it,

Roger Dansey

enough a focused in K trial to those is EV-XXX a Andy, places Cohort patients there more is in EV-XXX, of would but will great mind like degree, and Sure. both it’s a have global question more the to bear EV-XXX and trials. so enroll very United large that some than footprint. overlap States yes. are with

that trial manage are what to and we So recruitment them. is supported both trials it’s which adequately – make day, all of for we’ll sure do to

be have don’t expeditiously able what do. concerns I to that’s both we’ll any we and plan enroll So trials to that

Andy Hsieh

Got it.

company assets to highlighted. Okay. in and the was early And what past the some stage so executed saying the presentation has two years I see have perfection it’s guess, I so then in to welcoming you

any curious Just the and your assets Engineered progress and that assets just that immune you be curious, excited on the potentiating. on Clay, it thoughts Sugar SEA, into made the in ASCO platform are could heading particularly CDXX

Clay Siegall

Sure.

very you the done on how remarks your thank last has much few well So over for years. the company

that arranged can home We’re or work been for efficiency get and even focused people hard cancer working to on COVID time home. from cancer from patients working the we and really we’ve during approved, company help the patients drugs

a social in And goals very make have we the really with our our reopen laboratories even that. masks and work back decisions difference making hard distancing well We trying to so we’re lives where and on strict and have and – working. gloves, to make to execute laboratories patients cancer but guidelines the to people under and started focusing they’re in right

to time. we exciting doing assets, data. drug up and that Now ADCs developing we the the disclose and more bring that SEA-CDXX approved. plus an non-ADC prepared in It’s non-ADC, the more approval we it’s both is right at certainly the non-ADCs, that so there’s program. adding think a with that ADCs, remarks more our It’s and last mentioned and you disclosed. non-ADCs But question a are non-ADC, I first TUKYSA stage program, ready exciting the are any don’t on your We’ll it want is future. to you’ll that a I very data be to more disclose early hear in Right not now, about

so make a way. And difference excited any cancer we’re to in in patients

on work therapies cell. targeted We the targeted inside to surface or cell the whether they’re

I assets think stage our early very exciting. that are

some going next the I’m a quite real our lot But too have about early assets lot have I them We about or we and excited think until talk data to much two show. of we over don’t year hear you’re to assets them. about and a

Andy Hsieh

the questions. much very you for all Thank Great.

Operator

take Oppenheimer. Tuerkcan next Silvan question with our We’ll

Silvan Tuerkcan

to congrats in track my for clinical have development I muscle Since and question Thanks fast, PADCEV I development setting. here. invasive on that I moves taking a the make the question lose sure quarter. so your want on don’t

And you to first all, combo amends on standard to include new Merck Phase data, X a does So think give amended file? X Phase deal little enough care the in that this here? potentially did prior big setting the color a mean pretty EV-XXX of even could EV-XXX that second the PADCEV of seeing bit us and how what more an be and Merck to happen it’s a it this ongoing I views now as

Clay Siegall

really and we’re can’t insightful very doing you, attempting on and about on at Roger, But for on do are and or we’re of could time. I’m this. muscle their we we color what what trial tell thoughts maybe comment this what company we invasive and first question and and what is thank bladder the why And Well, is whatever just this sorry, comment thinking can’t and can give and important. you you we’re this to is any what little your comment Merck going why a can’t after cancer I Merck all,

Roger Dansey

Yes.

to ADC great question death shown and a combining I but immune them and a the again with So, up Vedotin not an kill help that it’s kill cell an has cancer could well cancer, an in is with also that potentially cells excitement warhead, improved immunogenic – think only environment a inhibitor bladder which response. set PD-X around that been

muscle for but are together registrational established cohort a as EV-XXX, out EV-XXX an frontline taking two combination and setting And data in that think with think those forward conviction that should really we of the eligible the invasive combining trial the gives we we take of and opportune this us. is So us join small still [ph] combination executing generated appropriate. this I already to cisplatin into opportunity course we

all cancer, And metastatic back is of advanced invasive Nectin-X non-muscle for invasive across all cancer. consistent bladder in and muscle bladder expression way the from into bladder cancer of the stages the disease

setting. generated differently this will in is So which exciting. believe PADCEV there’s behave with is disease reason already to that no Merck KEYTRUDA, data which pembrolizumab, with pretty has somehow

this two in which forward. these important cystectomy, we there an taking no is and combining step apart potential agents population from is think active them for really So therapy

Silvan Tuerkcan

Great. Thanks. Thanks lot question. for a taking my

Operator

time, I’d for questions Ms. turn back you remarks. this at Pinkston or conference additional no to further are like any closing to There the

Peggy Pinkston

operator, afternoon. Okay. for thanks joining Thank well. you and Be this us everybody

Operator

for you your participation. That concludes today’s Thank presentation.

now disconnect. may You

Seagen (SGEN) 1 May 202020 Q1 Earnings call transcript