SGEN - Earnings call transcript Q3 2017

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Operator

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

Peggy Pinkston

Thank you, operator, and good afternoon, everyone. all call. to welcome quarter Genetics to conference XXXX like of Seattle you third I'd today Clay Dobmeier, me Executive Cline, Simpson, Jonathan With Executive are Chief Vice Chief Officer; Chief Drachman, Commercial. Development; Financial Todd President, Executive Vice Research Officer; and Officer President, Eric Medical Chief and Officer; Siegall, Operating and President Darren and

those will conference the events all are may expectations Following conclusion Today's Such be are to June Please we for SEC including the unable documents we of from for time statements questions. our cause time prepared for or to Clay. current information materially If will call. XX-Q remarks the concerning XX, ended Form with over to we today, turn projected. get future of the with call that the include results we of results statements statements. the to call forward-looking in forward-looking refer that, quarter the regarding risk from XXXX financial to only forward-looking will available the could I'll performance And on the actual factors from questions, actual after future open filed vary contained any predictions based and the line those company's operating and differ your company. that materially to

Clay B. Siegall

the need. through program, of patients XX,XXX for sixth commercial And Thanks, the countries to was a We milestone company. Peg, ADCETRIS this everyone. and in transition patients transformational approved ADCETRIS' than our enabling Genetics, we cusp Seattle treated approval clinical by in anniversary important us bringing today XX afternoon, more drug oncology now marked the recently It a ADCETRIS is to of stage even to development lymphoma are good FDA. successfully on more worldwide. with

multi-product becoming ADCETRIS, strong are towards we a our goal in investing company. oncology pipeline Beyond of a

are trials, advancing vedotin. tisotumab vedotin enfortumab pivotal We in and two programs

immuno-oncology from significant pipeline agents medical expanding I'm and update several of for directed months. cancer. to an other novel pleased milestones unmet needs recent ADCs on have we addition, In at today you

of we with global $XX.X and nine tracking million reported of in for revenues the We $XXX months of to the support year estimate in for trial XXXX revenues growth, in lymphoma. ADCETRIS, to third frontline nine are million. Canada and approximately the phase First, of drive $XX pivotal realize are ADCETRIS the we most reported the The U.S. future potential full these To Hodgkin ECHELON-X expansions. X $XXX.X the year. first sales the conducting and trials months totaling quarter important X and of million phase is royalty we first designed label million

lymphoma. Hodgkin that the cures standard this its chemotherapy significant classical Therapy global statistically in of in on is frontline AVD arm. versus FDA treatment in primary combination population. by the improvement which X,XXX these with Breakthrough represent the of important the of ADCETRIS demonstrating control in containing previously study As long-term arm in obtain goal durable endpoint The to a is setting patients number to PFS highest usually modified translate reported, met the remissions, ADCETRIS patient the care. granted over ADCETRIS an acknowledgment improvement the of This frontline Based typically Designation plus a data, FDA for this substantial young in advanced

a on define believe Hodgkin substantial advanced supplemental population this new are we standard more after would decades. care in could for in a lymphoma We four to frontline and track patient Approval than soon. a ADCETRIS BLA submit of opportunity up open

the look at secondary primary more half safety The in the launch E-X Annual for and and details including sharing forward in the ECHELON-X Meeting trial accepted preparing ASH data first is from findings. team of at presentation were We endpoints for Our XXXX. the December. conference, to

patients with for subtypes. fungoides for in the who in trial X systemic We with large and lymphoma, phase together cutaneous CTCL. anaplastic primary Another patients important CDXX-expressing Breakthrough is ADCETRIS receive of cell received account these for was mycosis conducted majority Designation ADCETRIS therapy which which ALCANZA, Therapy

to FDA a This the by would T-cell are lymphoma. years, evaluating improved ALCL filed more frontline annually CHP could PDUFA in be to has to for and and in in growth ADCETRIS care peripheral of often XXXX. for the Hodgkin CDXX-expressing with drug in ADCETRIS ADCETRIS lymphoma, in of help increasingly in August to was advanced driver E-X Based December our lymphomas. a future over an BLA milestones is and positioned than mature fourth lymphoma for review the consult chemotherapy CDXX-expressing CHOP trial establish as ADCETRIS the XX. with occur on with E-X of patients. plus the another States. trial, for as of course continue E-X drug. and foundation and X,XXX Hodgkin the PFS A the are patients in anticipated U.S. patients In compared and systemic to care date standard outcomes PFS important patients. priority ADCETRIS be importantly, and newly indication T-cell is trial X labeled supplemental important phase oncologists third events diagnosed frontline is in of anticipated. United past data the Approximately its MTCL. six regulatory slower key become the lymphoma, ADCETRIS' plan even This of Our ADCETRIS We to significantly realize the expect referred report data in and relapsed diagnosed to FDA in our blockbuster we further potential CTCL, ECHELON-X

In have clinical recent ADCs tumors. solid our includes which we for made with pipeline, addition months, in two with substantial strides late-stage ADCETRIS, to important progress our

EV, which formerly was First ASG-XXME. as vedotin, enfortumab or is known

We single of EV cancer. We are primary objective with recently The rate. confirmed endpoint or advanced with in single metastatic locally co-developing Astellas. EV pivotal agent trial XXX arm, a response is patients initiated urothelial

near therapy, the lines setting. first-line the trial future, initiate in a evaluating in inhibitors earlier checkpoint are with also EV including We of combination planning in to

next solid ADC factor, vedotin in multiple development is late-stage is tisotumab This which types in ADC tumors. or expressed targets TV. Our tissue of

co-commercialize Genmab. into profits. TV the and FDA, collaboration, women for a Under advanced on with all from co-developing basis, We sharing a cervical single TV costs positive we cancer. XX-XX cancer are advancing Based cervical phase pivotal we TV feedback will trial in agent are compelling single the and data future on X arm, with

as in am that for tisotumab these the We XXXX. expect first vedotin the both with approval ADCs our pleased that FDA of need the as both possible. patients to enfortumab consultation of vedotin trial to goal have support half begin by bringing we pathways identified I rapidly and in

our breast to programs, includes more for tumors, In than ADCs variety CDXX-targeted three for earlier lymphomas, development stage and malignancies immuno-oncology SGN-LIVXA lead for a clinical hematologic pipeline programs multiple XX myeloma including programs cancer, solid our of agents. and in addition for novel

and the activities. will a discuss progress. Darren of will those our development clinical We and patients. programs that, After promise discuss stage invest Jonathan to results, over with I'll then in financial portfolio third broad to research our our At call will for highlight this point, most to Todd Darren? commercial advance continue and turn the quarter

Darren S. Cline

and were quarter, up up last by this sales net predominantly driven third another $XX.X quarter versus the sales in second year, of the X% This ADCETRIS vial quarter the growth. million increase record making third quarter. XX% Clay. compared to was Thanks,

stable the a disease. Based Physicians on approximately high with diagnosed CDXX-positive team in We duration The annually States upon consolidation the for the treatment our meaningful current that and believe commercial in we on post-transplant will physicians prepared ADCETRIS United offer see anticipated in Hodgkin their is the are look ADCETRIS lymphoma X,XXX market and indications. well for rely launch. patients research, settings. market our in continue forward the patients. share approval, approval where of relapsed We ADCETRIS to to and CTCL,

We patients. These provide to will frontline at increased research Market a of are the ADCETRIS with intent. AVD encouraged therapy Designation advanced FDA's younger is Hodgkin for lymphoma age, of patients diagnosed and ADCETRIS efficacy often for chemotherapy lymphoma plus with is meaningful the advanced a frontline combination option by clinically that are patients. goal indicates treatment Hodgkin of better in and frontline provide curative the Breakthrough

the that lymphoma bleomycin patient Hodgkin preparation physicians difficult share lung We experiences indications. is Physicians which new sometimes for Commercial to well continue encouraged bleomycin-associated are underway and from their frontline care old eager ABVD. with decade by are of toxicity, feedback fatal. can four these severe also regimen to remove be

are As commercial now the report we filled, XXX have pleased mentioned positions XXX. our anticipation field all sales force to nearly in previously, our we're and I'm of bringing expanding to expansion commercial that professionals entire the group over team field nearly approvals. these to

Todd commercial of to organization. bring talent and Our results. enhancing great financial call already over our the to new now members our will turn superb I the team discuss capability experience,

Todd E. Simpson

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

quarter net milestones S. important with record and million. our for third for $XX $XXX results achieving quarter of tisotumab U. in included Total and enfortumab a vedotin, to to financial year. sales. were sales ADCETRIS, in we guidance strong updates vedotin financially addition our Today, review some the In million. revenues the and I'll provide ADCETRIS had the This ADCETRIS Canada

last ADCETRIS total the in sales XXXX million XXXX, also to of been to million $XX nine year. territory third including million. this Royalty of $XX revenues $XXX ADCETRIS revenues bifurcated third months quarter in first in of quarter million, of the For strong. $XXX were of the have increased Sales compared

nine first million last million nine For of one-time the XXXX revenues $XX million from XXXX, $XX months months Royalties of in in compared year. quarter Takeda. of to first the were a included royalty milestone first sales $XX the

amounts royalty XXXX and higher by growth our over to collaboration deals. in for on million year. XX% royalties range territory Takeda. quarter, third the are and Takeda our under performance, ADC in we were full with year-to-date for $XX to have XXXX Based in increased our revenues by the reflecting be driven Takeda's $XX million earned guidance last Collaboration increasing in amount, that by Excluding $XX sales million the year, of sales revenues its ADC

of progress months included their revenues $XX of for Third milestone triggered Collaboration milestones million XXXX million. the were $XX with in trial ABT-XXX by including first portion XXXX revenues quarter glioblastoma. AbbVie, a nine from the earned clinical

$XXX are the in primary year. pipeline. $XX increases continues driver million million ADCETRIS R&D $XXX were guidance XXXX investment million and and revenues third our R&D XXXX for the year-to-date. in be the be collaboration increasing full the our and over We quarter of vedotin in to million to range enfortumab the to for primarily now $XXX the expense, reflect expenses for broad of

$XX our the We $XXX first line our SG&A full to expenses previous the nine range. expense to in million. This narrowing and guidance in are in year million with were million a $XXX $XXX XXXX, guidance expectations. months range third of our R&D million is XXXX within quarter of

million. This the completed accounting to the we $XX purchase of we quarter, hold In stock. registration income quarter, was result under warrant. million shares This the statement warrant common resale reported shares net X.X the treatment Immunomedics issuable for of the of Immunomedics' of a the third

As million recognized a shares we a end led the now on closing net result, is And mark-to-market. based and for of at the price the income of quarter, Immunomedics' the to it $XX gain, that quarter.

addition to the (sic) warrant, stock quarter second warrant. with investment million we Immunomedics' in or stock. shares million X In common common hold our of and Immunomedics' does not $XXX the [third investments. the include This quarter] cash ended in We

the Lastly, our I headquarters. Bristol-Myers Squibb's manufacturing we completed October, in that mention biologics near the of located wanted facility to acquisition

in in for payment quarter. improvement $XX for in reminder, paid the which And reflected of additional building we land quarter. an and second As and purchase a be will of the was October, million fourth equipment, the made the building

Jonathan. Now, to over turn call like to I'd the

Jonathan Drachman

Thanks, Todd.

recently the reporting we've and Clay look achieved in at forward data As with ASH full to several December. ADCETRIS significant highlighted, ECHELON-X milestones

I'll addition, trial ADCETRIS a than data with a and with across include our in frontline ADCETRIS second-line of ongoing In data at we're investigator-sponsored corporate and pipeline now We planned there the trials. lymphoma our at combination ECHELON-X are ADCETRIS which under dozen the turn advances year. support the ASH Bristol-Myers five-year and anticipate phase presentations making our nivolumab both follow-up another our for important meeting trial. from These other presence to collaboration more X Hodgkin salvage from in PTCL, trial Squibb strong clinic. of data programs in this

cancer several a vast a the the vedotin the solid unmet lead majority some The years with an the XXX are outcomes past Astellas rapid we ADCs who programs patients objective for ADC as Enfortumab patients and are patients, treatment evaluating response of options. checkpoint in previously advanced CPIs, and enfortumab that in or are of an do Our monotherapy planned and and the with endpoint been trial approved require inhibitor. approved vedotin. urothelial tisotumab for vedotin with locally potential or single-arm been checkpoint for medical cancer trial are rate is pivotal have There agents pivotal post-CPI urothelial of or setting, for benefit patients. inhibitors, need and Several metastatic in have tumors, no improving relapse pathway. confirmed representing enrollment yet not primary is development treated additional

also trial of CPIs cancer. explore and antitumor phase these We a metastatic with of patients anti-PD-X initially, tolerability enfortumab locally activity Xb in soon to or pembrolizumab, the with initiate for plan an will bladder advanced vedotin inhibitor, This trial combination combinations.

The our up XX inform ineligible plans lines including for enables vedotin standard in for In of This promising on future enfortumab The is who will is to tissue are vedotin or regimen. enroll to investigation the of like is enfortumab program targets chemotherapy discuss and tumors. with next earlier inhibitors. ADC patients, vedotin solid patients it of a addition, factor, expressed I'd we'll first-line many checkpoint TV. types in tisotumab therapy, which that first-line trial combination

and feedback As [European of for of the of cervical U.S. with metastatic (sic) in Society eight than In an women Oncology cervical approximately metastatic European phase X,XXX X/X Society devastating XX,XXX than improvements cervical generally trial of Despite treated this from patients, trial and patients will results and preventing therapies XXXX. to September, more data with result is response of at recurrent primary response confirmed from in eligible. cancer. of the including other in of cervical pivotal XX%. the cohort in The who and were plans The positive rate the expansion recently FDA, announced meeting TV of interim overall response cancer. Medical detecting Oncology] trial reported solid and is women tumors therapy, metastatic X begin be XX% will half promising. women the we duration a Standard the was Genmab reported at tissue in rate. with appears ESMO rates including after a also lung Based a that median responses include cancer approximately cancer, international relapsed still cancer standard types encouraging Avastin, a endpoint recurrent phase trial in metastatic with Data on Eligibility dose-escalation phase and/or previously XX or of for in diagnosed disease platinum ovarian if and express progressed single-arm months. factor, deaths. in study the X/X phase Medical less annually X/X an our the first XXX or

in We exploring keeping activity activities. solid to forward you will tumors look other of further tisotumab on vedotin be the these updated and

in which we plan Symposium single is of other vedotin a at our Beyond of the breast We enfortumab December. metastatic agent, robust San Cancer and with presentation tisotumab pipeline in include activity vedotin and to Antonio a cancer, in monotherapy ADC programs. data proprietary SGN-LIVXA, a SGN-LIVXA in They tolerability Breast disease. particular, evaluating report reported we're triple-negative as and previously patients additional

three addition, SGN-LIVXA evaluation In we're clinical of new trials. the expanding into

First, a in with Roche. with combination collaboration clinical atezolizumab under

cancer in research under a regimen a with industry centers. a I-SPY the by the FDA, Second, And consortium, part and pembrolizumab combination Merck. third, conducted with phase trial collaboration major in including of X as neoadjuvant

I'll with Our that three strong advancing collaborators promising our programs are technology. progress data. are also highlight ADCs Today, making using with collaborator

an from both announced the It from the They vedotin First, diffuse FDA Therapy EMA. recently Breakthrough and Roche PRIME B-cell this program. in is called Designation has ADC evaluating anti-CDXXb received large polatuzumab lymphoma. Designation

is begin polatuzumab expected quarter. the to evaluating phase addition, vedotin X in this frontline DLBCL In trial

preferred and with single developing to durable inducing as multiple killing turn is combination program both glioblastoma. Designation become an Recently, as anti-EGFR With advancing to regimens cells modality, immunogenic which various this therapeutic are And ADC anti-BCMA GSK for is as data. I'll of hematologic ADCs in death, third, believe for which early ADC testing for AbbVie ABT-XXX, Second, Clay. an we promising programs GlaxoSmithKline received important for myeloma, the advance a and with patients. and EMA. from has PRIME multiple continuing an malignancies that part of immuno-oncology agents could the Notably, through tumors. solid targeted remissions and partner goal cell a call percentage that, high of we ADCs that the back tumor of are agents, deep over announced

Clay B. Siegall

summary a our Thanks, and activities I'll highest key of close Jonathan. priorities. with upcoming

therapy. the on cancer; to inhibitors meeting the cancer; of in this of checkpoint including with preparing working the the pivotal BLA many in the on TV of preparing the trial for trials December; Operator, X supplemental XXXX. with multiple for combination urothelial approval enrolling key point, highlights in and lymphoma in XXXX; Xb neoadjuvant commercial dataset in E-X BLA to preparing reporting initiating report cancer; full frontline you We please includes for in Across at preparing cervical EV Q&A. to will phase December SGN-LIVXA our this and the a of ADCETRIS, submitting to line trial cancer; for initiate breast supplemental open For initiating with from CTCL and advanced EV in FDA and to we you E-X launch; progress. include call SGN-LIVXA, or data reporting forward Hodgkin our patients the inhibitors of triple-negative the in updated ASH and trial E-X data at look At phase from additional checkpoint for questions. keeping as in pivotal seeing pipeline, for open ASH urothelial

Operator

ahead. our And Leerink Please from with Michael take first question go Partners. we'll Schmidt

open. is line Your

Michael Schmidt

I expectations study? guys Cancer approval Breast into data. gating And questions was I SGN-LIVXA in the what wondering wondering, studies. the present from wondering was of EV a to my second the that phase questions pivotal part did then Thanks. if on couple and congrats great I help obviously was us for job San into Antonio do advancing question, you had taking TV Meeting. to is based potentially progress. on for heading trials I What of and rapid could program the factor early a X expect promising you with the you Thanks there guys. and advance Hey, SGN-LIVXA, all on into

Clay B. Siegall

to data. what Jonathan to All add for Maybe and see color said. a little the Michael, Thanks, wants some I'll right. bit talk if I

So SGN-LIVXA it very as but both is not responses. with program we're objective seen a triple-negative remind the about, cancer, is that at and advanced SGN-LIVXA, multiple let that really vedotin heavily we as present with protruded patients notably vedotin. very have seen excited that with we're enfortumab breast excited me And you the time in tisotumab we've fact

So that's expect at you some exciting. data more San Breast the Cancer And to report December, Symposium we in Antonio do noted. as

continuing far is of to analysis expect combination. there, As what ongoing. you and new that it's trial asked as a all announced. It's a single recently agent. There's in are our just with expect nothing should that Those you

So really combinations? multi-pronged you And bit there's a single about it's And different four combinations. attack, agent this single and the Jonathan, and the view one could data as talk the conference. little at a other additional being agent we prongs being here,

Jonathan Drachman

Sure.

very very at you good the around ADCETRIS hard see remind can has this dosing is potentially I really more think well the what of rates, as been have agents high not response activity. very schedule see this with ADCs which and So, combination And ability we Clay this inhibitors remissions. we've year. trials, we're I'll and working use some data that nivolumab, portfolio. of move expect data our that Where and of to checkpoint with also that in And only into and later have response year. to on on durable something ASH excitement combine you demonstrated We'll doing immuno-oncology later-stage across is high rate that but deep very that's have appropriate forward to to said, identifying we

with enhance combination into notice you population very diseases to outcome. setting difficult you'll Roche, one at of there's in So the looking inhibitors Merck one the with treat. that going SGN-LIVXA of checkpoint combination And using trials, to two difficult have where with cures this also, to try now potential a these neoadjuvant very

Michael Schmidt

information. Thanks the added Great. for

Operator

Barclays. next you. we'll our ahead. Thank question Geoff take And Meacham go from Please with

Your line is open.

Geoffrey Meacham

question. the for Thanks guys. Hi,

drill of we'll ASH looking really like to kind have about wanted to be think say, feel been from just have you next hematologists, they Just for the somewhat, adjust little to of maybe willing the to barriers cynical go a convincing more oncologists any Do or be that some definitive when and that to next And over that dose launch we bleo. I will bit enough the them? other say may information enough year, have guess, of label expansion year? to the

Clay B. Siegall

Sure.

So ASH you said next year.

in and ASH December to referring you're think how... I

Geoffrey Meacham

next then yeah, so launch obviously in the Yeah, ASH December and in year.

Clay B. Siegall

And what you that's I to. thought referred Right.

presenting on So, thanks trial. the data our for ASH, going key we're at primary Certainly, be the question. to endpoints. we have And

We endpoints. have secondary

have We safety.

hematology We're and excited and oncologists at look conference the data to We the real the come actually all have that. physicians, out at have lay all demographics. out the

to we're goal something in are of E-X our interactions of gain pleased XXXX this look very going with. half pretty our Designation getting We really approval the Therapy in that's launched. and were FDA we FDA also forward to for with get for So hard with and Breakthrough submission first our to And the working data. to excited

with about the asked of and years quite relapse ADCETRIS. of bit E-X? ADCETRIS could for little of a And in think analysis market very maybe data certainly about They've what comment think setting. question been with you Darren, about about docs And that what now our are using with E-X, a number do say and about ADCETRIS we've docs this. lot our a I docs docs You to comfortable talked

Darren S. Cline

Yeah, Geoff.

curative data. and Clay's for patient is Again, dissatisfaction while with as imagine, dissatisfaction there there very can in bit such have you're intent still anticipation post level to treatment some targeted ABVD there's is decades, a about population of a of And And of ADCETRIS point, been the still quite the label and physicians has on. expansion work we've bleomycin done therapy a good you the there. with last As removing the therapy. the a a younger comfort talking the some and a the four

we real new a of Hodgkin that patient in which treatment. bar lymphoma frontline in bringing advancement to believe So is the see that now ADCETRIS, population, going here advanced set physicians

Geoffrey Meacham

Great.

you. Okay, thank

Operator

Thank take you. Kennen from question next our go RBC. We'll with MacKay ahead. Please

line Your is open.

Slanix Alex

Hi. Thanks on Good afternoon. for the is Slanix the Kennen. question, congrats quarter. This for on taking Alex and

Just bit you've into wanted ADCETRIS unfavorable that little to caveating either dive on any regard? the any market with towards provide research based could in favorable disease I ECHELON-X. more of done color a potential was wondering use you got if the or feedback patients into you've and

Clay B. Siegall

Sure.

patients Hodgkin Stage called think Hodgkin So are lymphoma. considered IIb on Stage ECHELON-X, is consider Stage bulky Hodgkin bit is about lymphoma. way defined most where lymphoma. what and III docs of terms with lymphoma. as And be that's Hodgkin is also been focus certainly sort is And categorize advanced IV I by are, if advanced Hodgkin want of gray question think in when to I more to little our certainly your patients IIa going advanced Stage you toward, doctors stages, advanced the what early-stage you to Stage has it. is and a lymphoma is maybe

the submit get lymphoma has and that and and what Hodgkin Breakthrough label we're that with advanced pleased looked label, Designation until at while our in we advanced know don't title – that spoken doctors, Hodgkin market research we Therapy As we're will lymphoma came FDA. from today our we say

our they as to whole patient hands Hodgkin go, strive it certainly lymphoma. and advanced a we goal, FDA and with way different if look to work lymphoma of the put determine Hodgkin label. make at the the think And and that's they we're have the of to the in could characteristics So – right all the to the what that's to in the get is to going doctors assessment patient that's the that have determine and advanced

Slanix Alex

just follow-up If ask question. could that Clay, Great. quick Thanks, I for a color.

the to now (sic) on if modified relates has now the exclusion being research bleomycin, a [ABVD] based regimens, it be second you've the that cycle? where excluding where market been are eliminated context As potentially conducted, of used will, AVBD world the the in of after towards feedback you bleo can what

Clay B. Siegall

for the question. Thank you

been For using and docs at all. XX years liked have now, bleomycin ABVD, have they not

they really just consortium the stage that has a first never So even stage do with – it tested lymphoma on to because they comparing is And what Seattle what nothing said and said drop this clearly, depending we a X% to difference could docs in they was So trial see what thing you Genetics, ABVD. bleomycin? of was, it with could AVD docs did, up cancer, big XX% of Hodgkin in or efficacy. found was the did

pulmonary serious or you to efficacy percent six-and-higher up definitely, this, loss docs have with toxicity bleomycin. safety. – to efficacy connected only you due so So the give lose while with were have that toxicity very lung some and or unwilling mortally And about X% for of patients

toxicity, And can and wouldn't of you docs So but the use losing start well, bleomycin, if limit then can the efficacy. of less you bleomycin get also limit that use better. said, we you gee, be can

patient X% long-term, in to once disease-free do it's up way give something bleomycin, there's need so here it survival. response, disease, patients these balance. and not populations no percentage cure the saying only have get need the that's bleomycin. it's severe would you to curative where a death, which, And becomes disease-free you And where greater not that all including you doing a outcome. passed have there's you the doesn't would that of almost bleomycin directly and happen, freebie And is five-year really but this not for toxicity, due What and once always the affect in some don't intent, it we're

time. bleomycin it less to and than of same the can of rid can are to rate get higher get little with bit rather at and become a response we failing or trying it of get using a So that we it time, cures rid of likely rid finally sprinkling get and on,

it's pretty exciting a think I outcome.

Slanix Alex

taking Great. And color, Thanks the on question and again for that for congrats thanks Clay. quarter. all the

Operator

from our Thank go Salveen Please We'll Goldman take you. Richter Sachs. question with next ahead.

Your line open. is

Salveen Richter

you my research just means for treatment and stages, therapy in in you. Thanks market the following this IIb what market Clay, would for and about PFS then, for setting? modified And up comments effect impact just clarify what the Thank earlier setting? the taking is on how PFS first-line radiation on frontline and can metrics questions. your the Stage of proportion ADCETRIS the us

Clay B. Siegall

Sure.

the – it's Stage as IIb, far that. as on probably lymphoma. number effect XX% probably to radiation? a Stage you want market of III So do about it's and in Hodgkin research comment and rough of for beyond, Stage Stage Jonathan, IIb That's IV,

Jonathan Drachman

don't that's think II treated. or I that are Stage The required. in the consolidate And – main required order think, the not where bulky in disease disseminated more patients main is radiation to you really whereas difference the be response, is often I bulky Was to have disease. often Well, the way main felt in difference, your in disease, the that's question? that

Salveen Richter

Thank helpful. you. that's Yeah,

Jonathan Drachman

Okay.

Operator

Thank next Please you. take question our Guggenheim. Adnan go ahead. from with We'll Butt

Your open. is line

Adnan Shaukat Butt

plots could some shed in some Thanks details details of ASH, for the question. that you terms differences terms and ECHELON-X we there light be force Clay can maybe on there? are where or if in could the maybe see of Jonathan, at displayed (XX:XX)

Clay B. Siegall

peer-reviewed the the in The ASH of doctors front out for Thanks at coming much themselves. are conference. next earlier, forward all looking I soon, fashion even said out abstracts, believe, we're very to in Adnan. a I from the maybe putting Sure, data ASH the week, question. Like

a can't And to we the a little don't here? have so can few because but wait full you ASH Jonathan Obviously, that. color course, on Jonathan, think color for we the could you I of we of you date, give conference, give Adnan, give control bit items.

Jonathan Drachman

Yeah.

endpoints are that be there exactly would those think the we the talking I the Obviously, at. So subgroup those go the definitely of from be pre-specified and safety, we'll pre-specified I sharing. details including can't of are kinds findings trial, primary be about looking other details analyses. we'll subgroups secondary into and are, key that what but

Adnan Shaukat Butt

geographic differences, cetera? abstracts Jonathan, the groups, have those pre-specified et maybe will

Jonathan Drachman

what be very of abstract, would speak in to but soon. want the be don't details I you'll the seeing to those

Adnan Shaukat Butt

one just on Then enfortumab. Okay.

agreed is upon study, FDA? typical it single-arm with the to a hurdle efficacy an have For

Clay B. Siegall

Adnan, good and but that mean, because urothelial with horrible five you response high response rate. study, But mean, not – much the from to in there duration. in of certainly a looks approved and is inhibitors but higher range phase is low of look you rate FDA at with a And have they XX%. at a I we're – duration above. that fantastic with would there's rate that's written something that, I very them or rate response rate, have the response all kind were certainly rate a think response accruing stone. to We're there's our a checkpoint at low issue there's cancer really very X in the duration, a they duration pivotal approved XX% response a study. if ranges

is we it to not did see we'll what line shape. from hear gardening. in your before But hear And nor trip set think a I back certainly, the So I'd happens in to sand. normal forget, you welcome We Adnan, like a good there. we're

Adnan Shaukat Butt

on well. congrats and pivotal the you, new two – as going into Thank tisotumab well,

Operator

Thank Please you. We'll ahead. take from go question Boris Cowen. with Peaker our next

open. is line Your

Boris Peaker

taking for Great. Thank question. you my

approved, So is of my the trial. in that just anticipate saw in the And what it the and E-X? frontline we what you on do we be duration what we look is ADCETRIS the currently pivotal trial first in patients Hodgkin's lymphoma. Since if at I'm shorter advanced where question curious, know treatment than to real-world is practice? in duration it's the

So to compare would how sense real E-X a that I world? kind versus of just get want

Clay B. Siegall

Yeah.

the thanks So for question.

real of you And setting, average But in our doses, different. up about ended As doses of they Jonathan, getting could and to talk doses, was trial, in differences relapse we X the eight an And want ADCETRIS. in the had lower. you world that in be the X.X so indicated frontline do about frontline?

Jonathan Drachman

Sure.

weeks. two So curative XX be cycles every much very to doses that over ingrained intent And the is regimen treating for given Hodgkin lymphoma. in six into the calls

over ADCETRIS weeks. same is schedule times six doses two or six is given given now months, into so ABVD being months, over every six So worked and XX and cycles XX that regimen

And best the that be to relapse the they setting. much going do not can this a trying survival. that I go upfront to or and patients different way be long-term deal get treatment will and have to for as as are to salvage disease-free a with to think is

be drop-off there expect huge trial. wouldn't in I a to So the over what was

Boris Peaker

And second my Great. lymphoma, question also on guess. Hodgkin I

checkpoint starts on you I duration in whether I'm from two just ADCETRIS, impact treatment? new of marketplace? curious, approved now patient lymphoma. inhibitors mean, it's the seeing notable Hodgkin or having what are have are in We any they

Clay B. Siegall

– and half time Thank Opdivo It's the on ADCETRIS. for been revenues been the we you some a keep more. like with forward a for both market that each not question. if or now on quarter, for record have They've coming market KEYTRUDA And and been year on period.

on So do little a and comment certainly, of we're bit well you little any Darren, doing a there. want bit impact? to color give

Darren S. Cline

ADCETRIS But the benefit over treatment echo to on the is some the that. use relapsed/refractory market Clay, after will find often And they've been we physicians' and and Sure. then patients. in CPI go-to and do actually most over

think I data the and their our over to supports approval. that. So And years six clinical the just product comfort ability use since then

Clay B. Siegall

Right.

we a are Boris, The tell out bit is I'd a can doing Jonathan, and point study. we're about thing, what him like other And to briefly combination that that you little that doing?

Jonathan Drachman

Sure.

randomized, and patients great relapsed see a together looking two where great put when I relapsed/refractory or So really phase ADCETRIS opportunity the get can are trial ADCETRIS this we And refractory these and ongoing Bristol-Myers, patients, better in get population collaboration that's with a there's drugs even think and to look outcomes X we for patients. nivolumab. in at either

Boris Peaker

the data do that get we from should study? when you results? When And anticipate

Clay B. Siegall

with We recently, that. started Bristol,

timing So we're that give on not now. to right going any

Boris Peaker

Yeah.

Clay B. Siegall

will out CR there ADCETRIS a I Opdivo rate at phase which and look result. pretty point high what a But you is really data combined I strong. was when mean, was have it, as that that we the X done,

are that CR in data then have XX% intent. somewhere PR patients to the in you a relapsed there's rate. was Hodgkin the But rate in there we because really what's ADCETRIS also XX% – high see when and critical CRs So lymphoma, curative we were close approved based on,

CR ultra about CR X% in And indication approved our in the it in X% rate was rate that duration. phase XX%, rate, rate a for think PRs these a was X But I had two the XX% pretty relapsed Hodgkin. or a a CR And rate. and CR had like had we drugs we of setting combination CR said, then decent-sized Opdivo, study, in and I lot was, around you So they take single-digits. six-zero-percent important, is together good and a which

remind XXX the And led so, just the trial, that's the to you underlying data. checkpoint excitement of that to

Boris Peaker

Great. Thank questions and answers. taking very my much you for detailed the

Operator

take Yatin SunTrust. question next Please We'll from you. go Thank with our ahead. Suneja

open. is line Your

Unknown Speaker

is question a Hey, in guys. is on and this. taking Yatin. (XX:XX) congrats could PFS? the assumptions for Maybe my question I've This lower-than-anticipated progress. David for you another after on trial? all for this Thanks powering on E-X. on your And driving question What the comment the confidence And

Clay B. Siegall

T-cell data study decades data it's in been time where any around this to hard you're E-X, more three the CHOP and lymphoma, get a than you with exact because is case, do prehistoric. a all with regimen that's Well, Sure. taking for

evaluate we And so could how judge to best we did our this.

lead-in treated I'll an that we've And lead-in really is, longer. tracking point, well? we not looking remind thought. the arm and did in this trial, you was our trials plus that looking trial. happen are had the in and AETHERA and CR And at with better been concerned on so don't recall, over before trial, it were post-transplant time, based the these history? doing very data ADCETRIS doing is watching you what if doing little trials, the we events rate. XX% control really we if looking how We've strong. you than consolidation which doing And patients had At that really is our than slower trial, they're our And fantastic. this I'm CHP, arm takes know, X And a phase initially Is the

a said FDA happened conference they with on and who little E-X, very that we for certain we with, what relationship so very to agreement open talked publicly which great we label it, a at data we were we And to happened two point. success, ADCETRIS. BTDs a to we And went when got label. that's just call, said – this a out what and of have are for the it that. time now a that under strong an out with is trial that like we time point, we that working at point is and collegial and we a unblinded we And we that came meaning went And point, And and hit we of was and a about, the FDA slower. landmark, about went were approval

seeing and we We've So we what right collegial it's worked a E-X, to think about worked well seen I and this good we've just and be about want talk feel we're out FDA, really in transparent before. so and manner now. with actually

Unknown Speaker

on Great. for the opportunity in And the regulatory overseas? if international? for I is E-X? ex-U.S. And may, response guys Takeda the just there wondering KOLs with about have how's strategy spoken What you

Clay B. Siegall

for many a We They're partner speak ADCETRIS. meet and years with and with have Takeda fantastic many, constantly. been

interactions with great KOL guidance, As their with to with far and comments That's we them, as I and their their their provide relationship and them. specific encourage But cannot that. perspective would we a speak their territory. and have you

Unknown Speaker

guys overseas? spoken KOLs you that Have is Okay. the (XX:XX) with mainly Or

Clay B. Siegall

about KOLs we with around But speak of the Hodgkin – is globe, lymphoma We where our on. focus concerning course. territory

Unknown Speaker

Sure.

Clay B. Siegall

the we're But used. certainly, ADCETRIS understand is involved and how globe meetings in around

Unknown Speaker

you. Thank Great.

Operator

Andy next question take from Hsieh you. go our William ahead. with Thank Please Blair. We'll

open. is line Your

Andy Tsan-Yu Hsieh

taking for question. thanks my Yeah,

how expressed could you is remind expression there common for two, if one, in pivotal factor is threshold in us, wondering enrollment trial? cervical and cancer; tissue Just that an

Clay B. Siegall

the for question. you Thank

you a about I tisotumab address vedotin. turn factor may are little and tissue to this excited bit And Jonathan, really and about We you over expression?

Jonathan Drachman

Sure.

majority think not on it's to a cancer is fact, define the because solid you threshold there exact hard is that It's cervical need. tumors. many and other in of the clear percentage vast that I

trial. into or for requirement expression there a the actually any commented for it's very on not So enrollment would haven't whether And be exciting target. we

Andy Tsan-Yu Hsieh

you. Thank it. Got

Operator

Bank Ahmad Thank from you. next question our take We'll America. of Tazeen with

Tazeen Ahmad

how been Thanks a upcoming might about afternoon. to talking polatuzumab. taking Good get Roche for about And on you've bit Roche you're with questions. more your ASH. collaboration data Clay, that follow-ups. just are? recently They then molecule have of and the thoughts. some thoughts your Wanted have Hi. agreement your what if a revealed at get terms couple thinking of I to has even ever my wanted

Clay B. Siegall

and Roche. is Sure. here, our a Well, about relationship terms Eric with know Eric Dobmeier can little you and what, bit talk

excitement could GSK give you programs. have and some We also And with overview? maybe a little AbbVie and Eric,

Eric L. Dobmeier

I latest CDXXb, Sure. vedotin Roche that lymphoma. development for Breakthrough data data. in years. the targets about over received reported do, the polatuzumab them ADC B-cell some Yeah, to talk program. Designation the but PRIME they've disclose That's did for so can't it's an and has so is for Designation they

another encouraging, it the But obviously certainly be that's for to it's question attractive about B-cell and and something option lymphoma it's data. them answer more patients. So for timing asset would an for

Tazeen Ahmad

with have you that terms the then financially? And them,

Eric L. Dobmeier

terms Yeah, one terms. – deal of it's XXXX the the in earlier our Oh, deals. was done Genentech. with The

royalties low-to-mid fees, sales. it's milestones product So on single-digit and

Tazeen Ahmad

perfect. Okay,

Clay B. Siegall

done ADC we've deals. of number a Tazeen,

increased later did terms royalties of Genentech with really a deal little at it our stronger technology. great who of their ADC, It's came and brain exciting lot. And GSK, a a deal a Over time, upfront bit of of AbbVie, a little deal deal. other and have, ahead validation deal. and we with a milestones the And it's has a fees. years, did tumor our data a then then they and stronger was some with

milestone resources upfront on into we each the But to were approved and answer command programs basically, is deals. ADCETRIS royalties. the a able time higher of and effort your we going, expanded as and other to of So and question and prices putting lot getting were

Tazeen Ahmad

possibility is we going would to but PFS Great. can't there? for ASH a back the Okay. see then And that specifics, just know I numbers really the you it second. non-modified say a

Clay B. Siegall

not on regular Thanks PFS endpoint. and our safety. question. and and secondary And ASH demographics a showing is secondary primary planning for endpoint is at primary or endpoint We're the our

to the to upon what going and on we're agreed excited was SPA, we're data. in So share focus our

Tazeen Ahmad

driven on has Okay. historically, been Clay, from I happened Great. uptake you And And ADCETRIS has for then how KOLs the last got question guess, it by indication, docs? it community or I is me for the more as a terms you'll and frontline might about ask community frontline? docs initial to KOLs setting broader-based do think more using relative uptake also see it in setting, patient think of that you how

Clay B. Siegall

Yeah.

Darren, there. to comment on I a little think to do you make you're want something here?

Darren S. Cline

Yeah, sure.

diagnosed as I in there. we see they anticipate a to think the the were majority therefore, opportunity of with be you look setting. these at patients frontline, community we used And

has know, been you we've commercially six been available ADCETRIS – on As for years.

And so of using therapy. there's in comfort a the great degree

the uptake see do right the out community in we So gate. setting of

Tazeen Ahmad

Okay. Thanks.

Operator

And speakers. time. you. to this we further over Thank to at I have questions the no our back would like turn program

Peggy Pinkston

Thanks good joining a all have for have Okay. and us, we That's today. operator. Thanks, evening. everybody

Operator

conclude today's program. does This

wonderful day. your a any You have and disconnect time, line may at

Seagen (SGEN) 26 Oct 172017 Q3 Earnings call transcript