SGEN - Earnings call transcript Q2 2018

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Operator

Good day, and welcome to the Seattle Genetics Second Quarter 2018 Financial Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn today's call over to Ms. Peggy Pinkston, Vice President, Investor Relations. Please go ahead, ma'am.

Peggy Pinkston

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

its the Factors, tucatinib faced open call. uncertainty Seattle the approval quarter Genetics events, reasons, under remarks and contained or after clinical each ADCETRIS events or associated as and uncertainties adverse those, that future questions, company's about such regulatory or Risk future information developments trial regarding projected vedotin. questions. in a is for clinical we be pharmaceutical that clinical and to line launch available regulatory actions, ongoing timing enfortumab achieve ladiratuzumab the be Among expected regulatory statements and in If well the submissions Today's and all forward-looking Actual clinical sales may by the availability we're those risks unexpected and our include prepared the inherent milestones approximate and from including and development materially the as factors anticipated More cause company the to trials, the or case caption discussions, data as planned process. vedotin, will operating and difference trials, your such challenges Following Commission. and results with of or variety and the to outlook, company's regulatory future of from forward-looking conduct Form unable March expenses, conclusion among planned the obtaining including and differ potential new of the of the the performance statements. data conference And included third XX-Q include Quarterly filed enrollment thereof, Securities today, we'll including trials, for regulatory financial in planned call of quarter to to ECHELON-X, the from its XXXX, these other the get financial a call Clay. clinical and relating turn anticipated I'll a company's revenues, implied approvals in including company, costs XXXX others, will may in inherent the or the difficulties with XX, particularly in Exchange forecasting initiations, over to ended sales on with delayed that, the Report encounter for may

Clay B. Siegall

in was the grown results We've indications on frontline additional ADCETRIS U.S., sales by countries. relapsed positioning Phase year. but still in to the now of XX first regulatory our the ADCETRIS to quarter a approaching is expanded full half the Canada than early to ability to and franchise recently sales, the first up in ADCETRIS treatment approval with into third first decision $XXX need. Health U.S., available a Thanks, Peg; first be with of submission the project FDA The everyone. our from quarter years. us lymphoma drove U.S. We're commercial among a to the trial. million ADCETRIS XXXX. most accepted, Hodgkin in IV Hodgkin for Canada record ADCETRIS then, the data Since collaboration transformed in quarter bring approval. ADCETRIS the ECHELON-X highlights late patients the in first recently of oncology the frontline Canada seven-year the of Genetics million. approval in strong $XXX reception ADCETRIS quarter and pleased since for That the uptake from option frontline of XX afternoon, and Takeda, new XX% milestone launch, of more Hodgkin the the March bringing We're anniversary of lymphoma the patients and organization, in III our Stage good Seattle This two community ECHELON-X three after based lymphoma Outside lymphoma X into for E-X and to we've in indications. I'm

approval Takeda completed XXXX. quarter addition, E-X by data for its of the In submission anticipates decision the the first an EU and proposed of in EMA

important peripheral diagnosed to and Looking ADCETRIS significant ahead, the trial the upon PTCL the matured ADCETRIS a the mainstay as for referred ADCETRIS the we becoming have the CDXX in to grow drug, patients foundation a in U.S. decade's representing further or further lymphoma opportunity standard-of-care with there's medical for lymphomas, We need in We poorly with results Approximately expressing has early now to annually believe PTCL. substantial improve fare for fourth combination diagnosed a to patients ECHELON-X chemotherapy, Patients CHOP CDXX-expressing the it's expect with is with as care E-X an solidify newly worldwide. ADCETRIS brand an PTCL T-cell X,XXX unmet CDXX-expressing ADCETRIS. physicians also lymphoma T-cell and these are opportunity potential lymphomas. old quarter. opportunity and for and regimen. of

inhibitor. a received in a top checkpoint vedotin growing enrollment ongoing of the trial for the U.S. for agent platinum-based the submission cancer this we late-stage pathway. is approval inhibitor. urothelial trial year, programs cohort under positions the patients who next received This in patients pivotal in a pipeline regulatory has and three our partner ADCETRIS and previously first accelerated significant of with PD-LX us FDA's in could pivotal or half month, chemotherapy trials. franchise, of Astellas data most Earlier advanced, XXXX metastatic our a PD-X The a in line Beyond potential later the a who enfortumab in support pivotal completed potential which

Phase approvals to diagnosed trial the urothelial We patients annually XX% to intended regulatory as to More the X also global cancer. U.S. U.S. patient than and XX,XXX are with treated Up people a trial EUX in of serve enfortumab evaluating with recently inhibitors portfolio further a in in metastatic of in data, EV treated appropriate support and an first options, and vedotin confirmatory the at it's treatment to in checkpoint Tucatinib with patients rights. worldwide We're when presenting the available failed pembrolizumab medical late-stage substantial exciting look program in need. combination is this to our respond a and conference. also unmet require forward making with another first-line medical

is Our X is very metastatic Phase breast the primary cancer, HERX-positive focus global trial on enrolling HERXCLIMB well. in which

opportunities of we has inhibitor. other of building in single tumor as potential it tucatinib, breast a the in for metastatic goal expanding several program beyond differentiated beyond well potential this multiple HERXCLIMB including lines tucatinib with believe earlier trial as kinase HERX and HERX-expressing solid we cancer tucatinib work We of As HERXCLIMB the tumors. We plan tyrosine into to with invest development see types. in the broad

a Phase recent third to a in program. basket achieved the These in late-stage an is vedotin. started tumors. broaden to tisotumab we're evaluating women We've or solid first trials trial Our inform program And support with cancer pathway intended X other tisotumab the vedotin patient initial two and milestones. opportunities are Genmab. cancer. metastatic recurrent trial with in dosed approval we for cervical which We've accelerated pivotal developing cervical

progress Dansey. the on they the GSK highlighted multiple QX which strategy, in and during Seattle in we recently With update this worldwide. FDA ADCETRIS, can utilizes that where like delivering further multiple development novel in of We're expertise. pivotal substantial many making He have to programs new development An mind, growing registration presented oncology late-stage was types, also has of and activities drug BCMA joins ADC in several Roger where is of an the cancer. programs this myeloma, most our Roger oncology Genetics was including Chief extensive treatment molecules to Medical ADCs and submissions trials on advancing to welcome the for from tumor He results technologies in the to R&D Genetics. technology, the May the team. becoming and as path across transform with their a Genetics potential importance late-stage and KEYTRUDA Dr. GSK Seattle are other They Merck pleased regimens. example of collaborators ADC regulatory using important he ADC Our including our technology. XXXX. regulatory Officer, underscoring multi-product our in authorities broad I'd and project development led on monotherapy our global development. executing an Seattle with by launch combination responsible company Roger initial yesterday

turn our clinical Darren? to the an activities. lastly over going Todd and I'm quarter our our will programs; Next results. second Then on discuss discuss Darren will to Roger commercial financial update call provide to

Darren S. Cline

was quarter-to-quarter of the ADCETRIS lymphoma. XX% were Clay. therapy first Thanks, sales up combination quarter, reflects in sequential strong was growth launched. product driven adoption in and Growth is by since million quarter the the the second Hodgkin $XXX over of frontline increased volume rate XXXX. This net ADCETRIS highest

for of The second indication. quarter sales our quarter was ADCETRIS the first full frontline

associated expanded over community the chemotherapy pulmonary patients, with physicians, Our and Hodgkin for force and primary They lymphoma. severe have in of setting. efficacy XX% by AVD are been IV sales has Stage toxicity sometimes bleomycin. receptive of superior of plus our unpredictable to offered is These that reached III which oncologists treaters are frontline community while ADCETRIS the most the the targeted removing

caregivers we options patients ADCETRIS newly Hodgkin chemotherapy HL. to expanded our a aimed received we've diagnosed caregivers. start We've treatment our regimen. and of that be online their with asking spend with AVD significant a ADCETRIS before treated therapy in AVD healthcare begin. From initial frontline and providers, launch plus III confident disease several lymphoma to campaign reports addition believe a Stage patients launched our that physicians their educating at In and and the amount researching care standard marketing multi-channel field-based to time We've had of research, strong plus patients the IV remain the or and in efforts, market of know the

a could ECHELON-X started approval in the launch PTCL. and significant represent for ADCETRIS. sixth Looking we the for ahead, indication CDXX-expressing commercial brand preparation This and opportunity for additional potential

for we're addition plans. Roger look with to on the progress call turn vedotin. discuss and In preparing pleased our forward activities. with to launch I with and over during the enfortumab quarter to We're Astellas, a our I'll our ADCETRIS, the commercial Working potential we're brand you now out team of to updated. efforts collaborating actively clinical keeping building

Roger D. Dansey

and late culture team of matters. participate lives the and Genetics pleased I've for company Thanks, and Darren; been the the impressed the science-driven and call. and by I'm good day join pipelines, To and today's early the the everyone. with cancer every I'm in now, improving dedication two to patients. has to stage patients, months to the excited Seattle company strength both the afternoon, of

and ensure rapidly registration had our strong when in late-stage medical ADCETRIS-containing United patient XX% likely as patients efficiently consistent including a from have forward to programs we in compared clinical clinical III relative pre-specified the showing chemotherapy in with be several will risk as trials. that hazard we improvement bleomycin ASCO focus arm. ADCETRIS my of States. additional with our We primarily that data translates standard over analyses the survival Today showed impact lymphoma. in in where and practice a which I'll the the the stage reduction possible, all of ADCETRIS of reported June progression-free that from treatment containing and the This our or we programs. treated So a this address a to move frontline X.X. event care analysis absolute IV data death reflect of Stage two-year ratio modified highlighted at in arm Notably, ABVD can a ECHELON-X these believe progression North to in XX.X% a in is America, trial Hodgkin as

plus endpoint care of the CHP is Looking progression-free compared trial, diagnosed in to chemotherapy T-cell of ahead, evaluating E-X enrolled newly of standard XXX in The survival. primary peripheral which ADCETRIS we ECHELON-X lymphomas. CHOP patients are

in we've occurred expected. As the rate than a at commented, trial slower have events PFS previously E-X

early As a data analysis, we've the E-X discussions based the report fourth of line result regarding from had FDA trial the in we to and primary the top on quarter. are timing with planning now

activities upcoming At a now ASCO who dose, treated X setting the In majority session. on pipeline, from with EV, with rate. trial and oral Astellas. Phase had EV whom a late-stage recommended at start updated urothelial metastatic I'll or and confirmed in Moving were the an in least enfortumab a and of XX% co-developing recent two which vedotin objective reported including data we therapies Phase are X the of cancer our to patients, received prior response were we metastatic XXX at featured highlights

therapy in well-tolerated poor profile. similar was a We for X treated inhibitor. particularly Phase or XX% observed the rate in prognostic granted of in also trial advanced who generally These liver basis metastases urothelial the had of had metastatic encouraging with an breakthrough who by locally manageable with the response safety the checkpoint previously data patients cancer been EV FDA of EV factor. designation a subgroup a the patients with formed

recently to agent this called report the could achieved the top of agent potentially and single in Phase primary milestone cohort on trial in EV line Importantly, the registration trial patients another called program PD-LX EV-XXX, FDA's EV-XXX. XXXX. trail recent or chemotherapy treatment inhibitor. first single expect first and data approval we urothelial clinical with also in accelerated received the half in patient EV ORR completed first this X data randomized metastatic The mechanism. we the from the previously pivotal in a confirmed support These of enrollment We EV is PD-X is of platinum-based endpoint the evaluating cohort cancer both of which who

we're an We expected urothelial the enroll been published or United that inhibitor. malignancies. a to dose it and EV, previously well patients as confirmatory with to trastuzumab The PD-X is highly with cancer, with regimens The well-tolerated, being Oncology attributor overall survival. and the Tucatinib regimen which primary trial full with I'll results metastatic to the and for The safety Lancet metastatic turn One tucatinib XXX The continue tucatinib developing TKI well in most breast to metastatic is our potential cancer. with HERX because the submissions molecule able capecitabine oral trial of other program, key reported small Xb trial HERX HERX PD-LX as of is was a in TKI-containing recently regimen HERX-positive triplet of as patients trial, best-in-class. in has other have the regimen tucatinib this EV-XXX expressing be for and tucatinib. targeted This is States. in of favorably who on breast an as rate selective tolerability platinum-containing Phase are tucatinib, compares cancer serve to trial support pivotal trial HERXCLIMB. meaningful tucatinib now the regulatory in global in as or clinically with the versus important Four randomized is the cancer capecitabine and believe to with such we for supports the breast broad or toxicities significantly for inhibit with rationale there which diarrhea. HERXCLIMB treated endpoint to metastatic intended an tucatinib and of trastuzumab. combination and profile, tucatinib ongoing potential reduces is patients and EGFR, placebo Based trastuzumab, received is with trial not on rash brain as of this does it endpoint patients that's T-DMX. include that metastases metastasis overall without key PFS and this endpoints secondary The survival. previously and brain in primary who've pertuzumab, of progression-free survival HERX-positive is

Xb to submissions XXXX. we with We new plan the expand expect of of studies support a a the months, of globally. regulatory with This this Data tucatinib Oncology In combination in published to to lines metastatic potential from program support the as complete cancer. tucatinib of JAMA study in recently enrollment combination is HERXCLIMB were the Phase T-DMX breast in trial that U.S. registration and to plan in coming intended in tucatinib consider approach. earlier

colorectal We tucatinib pursuing HERX-expressing cancer. interested also solid in tumors as in gastric and such cancer are other

goal lines into the are of with and regulatory FDA's under with This other Genmab the submission cancer. treated vedotin, tisotumab The women setting or third TV, line XXXX, is pivotal cancer. is our endpoint approximately TV's start TV support in are third monotherapy also XXX We We of the Target a innovaTV and ORR. line. in is second is line late-stage pathway. goal planning approval in first accelerated co-developing single-arm the in likely earlier trial with pipeline combination intended will second cervical cervical primary with potential program patients Phase understanding clinical with moving TV trial in called to XXX agents a the in of the or X trial initially we study with first Genmab. Our recently of patient which enrollment in

the types neck, and Phase trial colorectal, patient including recent to another trial. and development Lastly, we the basket is pancreatic, X four that is solid that TV. head expressed potentially highly and cell This with accomplishment colorectal of first a tumor factor non-small head tissue program in This program treated enrolling designed a inform TV cancer. neck, expanded is lung and study

Todd results. to over call the financial turn Todd? our review I'll Now will who

Todd E. Simpson

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

to financial a in our second $XXX second year-to-date provide the ADCETRIS and XXXX million for addition I'll and quarter Clay financial This expansions. pipeline, the as in our second included of as In ADCETRIS $XXX are and updates million for and the second to in as our quarter million. $XXX net mentioned, were the in $XXX we reflects guiding for net the our year-to-date. on quarter revenues in label Canada in quarter quarter. million of summarize outlook comment and in with U.S. some Canada third I'll million strong to sales income the net the across sales well had also year-to-date $XXX and recent Total year. for results progress Today financially. record XXXX. And were we U.S. $XXX and ADCETRIS substantial quarter the the million Growth

in experience million quarter revenues gain updates. to utilization monitor the of setting $XX continue to in frontline of half last second further increased to dynamics, first provide million months XXXX. the market the for million we to Royalty $XX were $XX in second six of ADCETRIS and with year. As we'll And revenues royalty compared XXXX, first the of the million in compared quarter $XX

increasing throughout Collaboration sales with collaborations sales to in amounts included This those our royalties as grow milestones Takeda totaling rates. ADCETRIS and the our were AbbVie. with under collaboration $XX ADC second revenues clinical higher $XX include increase under royalty year and trigger the quarter, which expect million as Genmab, earned our GSK Takeda We deals. and million

expectations XXXX we've million in progress-dependent, included than the milestones that half in million collaboration range $XXX first deals. in To-date, result quarterly bear are our result ADC for The $XX that mind therefore, collaborator to Also items variability. of more $XX us increasing million. to our generated year and revenues a under of

on registrational sales receive quarter $XXX ADCs pipeline our increases late-stage now addition, the million XXXX royalties were XXXX reflect three R&D expenses programs. trials. stage and we're the earlier over single-digit in million use that in The In entitled of year-to-date. ADCs technology are collaborator $XXX to and across of and our investment second higher for

quarter second mention the housekeeping one reporting I XXXX will and in the $XXX transition six reflect stockholdings million launch $XXX As ADCETRIS a lymphoma. shares call, million more entered expenses of net the includes the upfront first XXXX. into $XXX cash We $XX Unum. to technology acquisition quarter the with support in in our XXXX. and for gain associated million discussed in first ended that licensing agreements and last Hodgkin of as to resulted year-to-date matter. SG&A in in of common were second second resulted quarter, last in corporate and cost of expenses us frontline which million this costs Expenses in in This our you in $XXX of Cascadian afternoon. million related release in are and during mark-to-market, saw months Immunomedics addition last than to These $XX press commercial payments investments. income with million in quarter quarter in the is the

a have soon. XXXX. Investments, that in rights expire several remember, Baker participated filed who Brothers our since ago will statement may shareholder a with our registration largest you years We financing registration As we agreement has

we As With later registered. a supplement keep call turn a that, will be now. I'll today prospective the to result, to Clay filing shares those over

Clay B. Siegall

in I'll XXXX. of from milestones over the They of first, trial data include Todd. Thanks, early reporting a the short summary III close expected key with ADCETRIS ECHELON-X QX. Stage remainder

the executing first for Second, urothelial cancer EV-XXX positioning in line half trial, data of pivotal XXXX. in upon top EV it

of line bring to the this and of front excited the making the opportunities cervical patients lastly progress for enrollment we'll please trial TV advancing are and and tucatinib drugs of continuing open to call by in point, open the in breast cancer we us additional need. metastatic Q&A. for pivotal Third, At in Operator, HERX-positive the questions. trial cancer. I'm the HERXCLIMB pivotal and substantial

Operator

will Thank come you. Cory And first question Kasimov JPMorgan. from our with

Cory W. Kasimov

quarter there. Good afternoon, questions, for and guys. impressive Hey. taking the Thanks a nice

I So year. opportunity One, you. E-X. on one and for questions on another It's guess ECHELON-X two

point? you've question on talked in own During And still, does really population And many literature, if bit with you physicians from in research, more what's your little (XX:XX) maybe full opportunity. point then, a I'm overall and second CDXX-expressers? guess, at percentage are wondering moving the And their from full issuing frontline with and that's the sales account up launch and impediments specifically ECHELON-X and I think wondering regard is regarding there this I'm at take Hodgkin, into quarter the guidance on patient first early how the your of parts E-X the any in Thanks. experience to size. preventing based wondering you uptake, year of feedback this this matches in past potential terms this market how the

Clay B. Siegall

you great in did quarter. quarter. the I Yeah, all, the thank a for of first on Well, think nice our comment job we

IV. time on talking a opportunity, since to in see a progress. frontline that think we they to doing we're in take faster and But Docs initially, expect had how docs. – from docs. to feedback Stage on this bit that job we've that calls. the about we're patients of docs on quarter-to-quarter. little over conference use And docs. talked who making up. good. you'll great It's field. than the And bring think And And docs and expected been It's been academic lot it out change the the treat take this great number I And a more it great there'll there Hodgkin a So years into the We're I EV-X been AVD III ADCETRIS really in for community we we've using really lymphoma. a there's focus academic XX of be are

onto guidance far expect it first forward, less. we We we going be surprised rise far for have we feel and make year a possible thought be about our We're to working And it frankly. we this analysts We And we convenience looking what's to out about. feel to be growth. that going think the XX% We through little We to gradual. goes, But there We're early got we to sales, were don't to And as whole to not with And quarter. year it good really doing would we stay go little guidance As a pleasantly will we earliest on right year this happen we're that back adopters as back do want had. guidance want quite until we it. we we it yet. that that. – and at And go once full with in that. But provide years. certainly a a provide feel it the investors get quarter but strongly that want bit the many we didn't lot moving full guidance. more will as We'll quarter-to-quarter this, go to back will did fast closely. to, the some the really confident sure at really strongly we tuned.

far the opportunity IV does our And III E-X does and we'll the E-X, earliest do Stage convenience, little they're or lymphoma. – it. match than Hodgkin Stage X,XXX as for it at about so size And IV. as – and both X,XXX III So of a possible bit more the

lymphoma bigger T-cell Hodgkin size. you lymphoma. IV T-cell when we CDXX Hodgkin, the we at that's you If Stage been look and market research than positive studied the entire is And on – the that, same But just have it and have look III and obviously and demographics everything. that's about at group, lymphoma

of that confident So we're population. pretty type with

Cory W. Kasimov

CDXX-expressers? all they're And

Clay B. Siegall

exactly. the are focusing We're those CDXX-expressers on X,XXX

Cory W. Kasimov

really perfect. Okay, That's the taking Thanks for helpful. question.

Operator

you. Thank

will MacKay RBC. Your from next be question Kennen with

Kennen MacKay

holiday the Wondering, you wondering, in on regards ADCETRIS. in thank even Wondering question orders about represents detailed? wondering just expansion for Hey, in prioritized what ahead if inventory any you the upfront. X pull percentage of was June the sales increase associated build I you Or ahead and we if little saw a that Clay, some or the congrats and forward population bit of the taking there was and comment quarter. are XX to that of that there price maybe to for have clinicians the detailed with sort of of the remain haven't be providers how that this And then, targeting yet, U.S. your physicians July just these was been housekeeping

Clay B. Siegall

on both Yeah, and thanks commentary of Kennen, quarter. thanks for nice for questions the the the

color on do? and can a little bit see typically, a you that don't we So But, Darren, what we don't really this inventory We of build. see the inventory/. accumulating give

Darren S. Cline

a of typically Yeah. efficient we a see in very frontline the the When stocked not ago, Hi, access lot that a about to this diagnosed gets is product are patients we for indication distribution seven launched think And drug don't time physicians. And inventory. years ADCETRIS model Kennen. built you has of typically in we if or just the where community, particularly, the XX% that.

Some academics stock don't based we a patients of settings see and But that on just again, of so. or their for ease it. week scheduling volume the treatment may

We haven't don't with seen the uptake. E-X and here it it see traditionally

Clay B. Siegall

commercial we're and of It's you what the we're doing second our turn team. can that over talk Yeah. providers of great a also detailing. Darren, that? targeting of And a question, really about then, really Darren. it about the percentage we're the to proud little And part job. I'm

Darren S. Cline

Sure. Yeah.

in we recall, oncologists which treated about community. the frontline target of will about to able the and last narrow us And completed of we in if opportunity majority we we're year. in is on other entire expanded universe really that the in that to Kennen, and presented was, the of geography, you setting we know based saw the United couple was in where the States sales of X,XXX. quarter the So in be a Hodgkin focus to so the X,XXX whole really And X,XXX, there. fourth on factors, allowed and or But to volume, force,

about to the reached we've on will XX% and continue physicians, indication. those but those Now, docs model of benefits data in the educate the call frontline on be with to to our continue about obviously

Kennen MacKay

Thanks much the for taking you. so Got question.

Operator

Thank you.

be will from with next Our question Richter Goldman Sachs. Salveen

Salveen Richter

Thanks my on quarter and as for well. the questions, taking congrats

Just quarter. One me. the around three questions for

quarterly QX. you how just question. truly conservatism with studied you the at in the and there over make with this But So early Secondly, this QX launch. you would back to in just could for regard look given just growth a rest you're walk think the more population that ECHELON-X, anything stratified high that in if I year? positive? your us you the this my conservatism differs I out it think, guidance, through earlier gradual? that end the this And I'll Or is trial? recognize of watched of is that XX% come last you growth as bit XX% is seeing like for population there's from quarterly looks be ALK And

Clay B. Siegall

Okay.

standard our I And we It changed we forward. were annual are that's every to and X% And giving This time not yet. conservative. we Remember, off in adopters in. in we time. takes it And XX% we to X% on ready. be know – I'd be, I market going just going to where share a ready. quarter-to-quarter. is should were rapid guidance quarter forward we're the in delighted don't looking if and So believe stepwise each start. the annual this in up hasn't of were the go a And quarter. were setting where making first XX% years. team to was commercial build guidance. moves of got to But up quarter, XX%. They care They guidance just good quarter first don't first XX takes we'll this that our the jumped isn't say, at time, of But all, quarter there. this rest full the We be up we're up

giving a going just I sales new how and market. keep we this because a conservative way were it's assessment it. our think force. much believe it to you analysts pleased how important. reflection based was. get uptake think transitioning you were of And to docs by not there to to them going were And other want We on on of this And number a that's what's AVD. market to don't So the we poised it's on repeat were go initially to very And we're I we taking we're what our to of surprised little And expanded our we and jump I'll on and on. past. climb just ready That's a believe positioned be with But the ADCETRIS to really and out the this. uphill we we

for AVD it. in do As now, and they're Darren to mentioned, some patients what about They asking disease to their trying learn the come Internet they're they out to ADCETRIS to about about when go figure this. learn

So we're with really that excited aspect.

second come with a much really a smaller treating to to in question Going your data. we very lead-in that what treated, than We're we're now. smaller is now, E-X, that we're It's excited what number, number E-X. our have out similar study population with treating to patients the XXX on

We And have predicted. event number was than the discussions regulators. slower we had with

with time was and mature is was SPA. most with a good trial And to mature. a So where we the regulators spoke the important thing, really this under and the that's up data came

Early this new for the early and fourth that's And be line quarter, so the data. in top this unwinding and will – in fourth reporting we quarter call.

Salveen Richter

And question, can moving HERX into earlier you into HERX and breast lines cancer around cancers? the maybe just the about how just of give us moving other on you're then a Okay. timelines then in just sense thinking tucatinib, last

Clay B. Siegall

Yes.

So you questions – two say that again, earlier? the moving of

Salveen Richter

So cancer earlier of cancer, just moving the into how colorectal around which and gastric about moving thinking you and timelines then lines into about, talked that breast you're studies.

Clay B. Siegall

you. Got

take one Okay. Well, let me second the first.

clinical specifically. with a colorectal, going in cancer. trial. cancer, go in go your you're you We've And It's outside already is very announced And cancer. forward. how So question important when commitments in with I yet. pretty ClinicalTrial.gov, it's with And to Clearly, density trial is you spot-on colorectal possibility an in noticed is look have ongoing. not anything if to we And that we're it's there cancer happy and an In the investigator-sponsored made colorectal we're gastric cancer. gastric gastric HERX colon think cancer. breast it. cancer. excited in of no high We expressed at But

are thinking We about it.

going So about in like this to and a general, maybe I a then, tucatinib, thinking perhaps Cascadian a from we Roger, about that. we're Roger, into would little HERXCLIMB you trial talk from bit you program. to we're a say, as stay little about And talk tuned that making can And on brought would how that.

Roger D. Dansey

Clay. Sure. Thanks,

than Clay we tucatinib trial breast a rather as do representing really So in cancer. has as a see program articulated,

TDM-X possibility a was So, on an therapy thinking potential a that plus registration profile. for Response exist could consider based encouraging. there's But is reported could of very also out through rates The an interested interesting. we're adjuvant it's potential tucatinib for line that quite profile and approach. treatment. And tucatinib such are use early in of safety we its is are – example, what earlier as the the that of example on data combination favorable we in

So our where of those two is. thinking are examples

Salveen Richter

much. Thank very you

Operator

you. Thank

Tazeen Ahmad will Our with America. Bank next from question be of

Tazeen Ahmad

guys. afternoon, good taking questions. Thanks my Hey, for

have you a you're the use of I do to potentially on frontline, give early just Stage wanted are meaning, seeing you're secondly, of expecting cycles treated adopting sense setting? all but the or for average First are I one, use label realize Stage that. you whether that Clay, frontline can frontline get II the the what across HL in launch, from us you the preventing also that a physicians sense patients some in color And of setting? on getting is in

Clay B. Siegall

question. I'll turn All right. second over answer I'll Well, the one Darren. to first

Our IV. Stage in label is III and

promote very Stage in that's our and IV. we III team. really something commercial much And I so think with that stick that to And we

in a earlier alternative. we looking like where on get have toxicity. Or stage, do especially starts some an And about patients they really docs little can't and a have patient that pulmonary hear you bit then bleomycin. from Now, pulmonary for they ABVD insufficiency they're and

cases can But of see and where I by are label. large, not part the it you it's there think there. I think

and substantive it there. Hodgkin And average And Darren hearing so what to trials to in then despite on the to about there, lymphoma, give it's we're cycles what thoughts few over here frontline cycles. not there this? talk any that's solid of you I'll sales a we're getting The turn seeing really a on little anecdotes Darren, average clinical we're we But, out this. – our did in seeing what to early something and our in clinical number

Darren S. Cline

And also these dose this onboard growth you But to Yeah. discordance seeing the just you I is intent. can curative The on is aim all across And time. again the gate think trial of just with frontline in ensure various this utilization trials about think patients look community, – reasons. That setting, when ensuring ECHELON-X planned dose for to physicians the was and this disease our on and approach that if XX we're for cycles. typically there about cycles. right of physicians was in the oncology and for the then give out I get that – little XX there at academic planned factor bit full time a think centers embrace

your it to early. point, So is

this shaking the for that's be absolute physicians. intent But what it and studying and the will We monitoring out. understanding it's utilization, how these

Clay B. Siegall

Yeah.

frontline tumors. when have not the Hodgkin same which that you lymphoma, and all think is intent I curative with like

response, fairly tumors want patients, But frontline, in you to the survival their in curative-intent high and stay patients or of it's cycle. a -unfortunately, on a just there's depending is curative full a of this, in intent As because matter really PFS, or not there a on of even get it getting since even is lot cancer. know, longer percentage

X.X% these that first in see So in That trial. approval. in very which We trials. probably we had cycles I because we'll had And relapsed XX And that asking out the did then something that thing, each was in a our prior our clinical perhaps were cycles real about we two world. different is the patients pretty setting, averaged different. our our you're in close to think question, that the refractory

understand I that so And question.

I a fair upfront intent a question. question. think say, and with the pretty with it's But little probably a close. And fair curative but and will to healthier see patients, something think think early that I the I it's

Tazeen Ahmad

number of mentioned related Okay. last around that Thanks to would the one color. you to cycles be average of that real you just question setting for E-X to cycles? – And expect X.X then, for related closer population, world see

Clay B. Siegall

try data there's wanting white intent. yet. We like With our don't depends a curves – this, strong the stay the if curative E-X, data. I Kaplan-Meier space ALCANZA, you'll come did they're think of with on two between on data see the absolutely it if and have some have you we out ton to and And see to patients and with

And so that's I think different.

an initial though are But XX%. CHOP relapse. and substantively CR when of years, over And responses there's chemotherapy, looking some less think you start but long-term or those when disease-free there. rate look it's there so, patients about you at than some XX% I of

depends data. strong, if it are on patients our you stay bet think our on I And so And will data it.

You bet.

Tazeen Ahmad

Okay. Thank you.

Operator

you. Thank

Securities. will Butt Adnan from question next with Our be Guggenheim

Adnan Butt

on results. strong one on ADCETRIS ADCETRIS Hey. enfortumab. Thanks congrats One and and the on

ADCETRIS, For study X/X are a conduct similar of type factor a or growth any to there Phase plans broader support? maybe patient in with population

Clay B. Siegall

question. of all, good it's First a

I don't we're – want commit I think are to that it lot there possibilities of anything. is to a discussing.

you're in to learning that know if registry learned this, and Trials get, do we and to growth we we this, If study really are details, try factors asking is details. a data we going And kind but see also just do think now of we experiences. something include what some lot we that and from our all we X,XXX went knowing what about patients. are support a of

than we've lymphoma in patients I think to other at a in most FDA company. I appropriate probably we treating their Hodgkin any this do more you're that frontline And know learned going label way is is this. that about way in the way the which has advised that think

get pushing It you data. to we at going XX% label We registry possible high think, study, when I potentially look potentially a think The and our could get reasonably that rate. is is close in we're there. they great. And the XX% to so But we cure all do did. in if

and get a this we data medical our the with at you very and exciting factors North have in But growth were excited. forward ASCO and the it are at to talked journal major we're the it prophylactic We're presented we're things, about trying really into writing putting to trial. look We data ADCETRIS soon. American using if all experienced up published and and doing and that docs that looking

you're yes. a registry if is The we considering answer are asking, So study.

Adnan Butt

pivotal Phase enfortumab, Okay. there patient lead I Then, the the between and differences that. any are to look in Phase lead-in duration? the to on X or X populations forward in could would differences either response that

Clay B. Siegall

just a had Phase had But a okay? X of So all and had a there a platinum that population, checkpoint. very couldn't in we platinum. couple – patients few were patients patients checkpoint, prior the But get most the that

we two last you the about call our what we're that both if one that's conference with some platinum you talked had did going little There's with changing low at them the and frontline. the different the first. going So in that's vast cancer forward really There's the And of on two will. And we things bit. been forward the treatment majority of what on cohort of – we And urothelial just patient enrollment checkpoint has was when cohorts, both. look cycles. prior have pivotal study, high the in is they're PD-Xs going to a – we've And the we're completed go been for. whether or what

has get a that that's and Patients all. at That So checkpoint then different. inhibitor. touched not little platinum

answer would using to almost that patient your we're identical and by question. say, in population, regard, I large, So

Adnan Butt

Okay. Great. Thank you.

Operator

from will Yatin be you. our Bank. question next with SunTrust Suneja Thank And

Yatin Suneja

bar start a taking guys Hey, for (XX:XX:XX), early (sic) uptake resumption from detail regulators? readout, questions, any on I maybe also more have in could feedback And the [E-X] the E-X XQ bar what quarter. with have setting. talk in the guys. and on and a my you Are let an to about received for that. add congratulations do go Maybe also question is my Thanks me on changes I'll bit trial approval, the the little good you for another you making enable and after that

Clay B. Siegall

Okay.

clarify, about I think, you meant to E-X, and you asked Just E-X.

Yatin Suneja

sorry. E-X, E-X. yeah,

Clay B. Siegall

Yes.

to You you. listening I were am me and just testing

as feedback did as conference were from with at calls, we meet with regulators, we meet regulators. earlier to going had far We So said regulators.

years, talked We The we've regulators. a We out, are to said how most about. patients is here are and talked Yatin, what the that with have important are two-and-a-half many set, met the how thing, data slower. them. three two We've we have months, XX events. years, the That's mature events events years, coming what are

great FDA to different information we and lot registration We studies is five-for-five discussion look So got see a at of on very with had approvals. back had. it, ADCETRIS very you collegial, When positive.

have there maybe lymphoma. out up asked of doesn't and years. number we and we B-cell it patients. been unfortunately, sand. When CHOP lymphomas. transformation we're with approval. behind on on XXX, it And such for just decades a mean to then four-drug like in in you feel number So three-and-a-half really chemotherapy. our still have seven as number – chemotherapy endpoint standard and been after there's and for don't it's care this with difference. line six know, E-X. We in interaction six T-cell lymphoma, we're a The for XX the was get that FDA good about for with lines T-cell regimen. have have that see you the right Nothing, in control PFS, B-cell CHOP now, working was CHECKMATE a no we future. is The we But – the great arm about And that. more And has in transformation regulators. that But the But our the you bar had about I in I sand And the make a is CHOP.

neurotoxicity And ADCETRIS, trial of we we want (XX:XX) on letters So have CHP saying, want to because look, top on spectacular. we lead-in we're we're got with sitting some to add out Ocovan we our one – don't drop here, of this.

We years it's we're Over and has haven't that early line numbers now. And five and We years. XX%. We years It's out putting small patients. track the track, reporting And frontline we're And haven't And flat. that's have data way. five after a event keep a our try in if trial. trial. yes, event are stage. like unprecedented we're T-cell five-year away. the to XXX been lymphoma. our an very to And is by is arm fourth single bigger we're do five lead-in – that's These we a you median on for hit And had is. after years granted But OS years, And change doing. a long our to prove mouth money a what the it where through doing away, it quarter. this. guiding not this this we're been on put months We're now over,

to think statistically that So I need significant see we just data.

to think lines if and the and is two significant just have our to it's and ratios the are parts data. we going care. we'll Kaplan-Meier not the have But see hazard so I no one statistically bad close,

Yatin Suneja

only to of And to number a there on events any that this or is landmark that the will clarify, just readout? was – reach pre-specified XQ based guidance analysis or naturally, the change go the to trial so for enable you assumption is

Clay B. Siegall

date. what of doing. But the have specifics up we're haven't a and We said come we

And pulling on be this a so to we're going out date.

will come be coming we out – out. when It'll feel confident know very we So fourth quarter. early this

Yatin Suneja

And bit quarter maybe accounts little then, added a on the Hodgkin, the IV? in did two update you on Stage just comment question on mix can months. also, versus III the give in frontline last you first the new on an And ADCETRIS a it. think you Got patient that call, I

I happened Could give an us think was in you there? it What update about XXX. Thanks. QX?

Clay B. Siegall

Sure.

have far you counting with really difference. wasn't American III little frontline the getting or all there data a the a the there look into experience, was sites, when at start set entire you Stage IV, when as data down of As difference. international docs that North But

I think much I there's there at at. looking that of believe And – to that think don't be don't I so for a you docs it And difference way. that look don't

So I we'll there think But a leave other question, see it's don't there's a that it. fair difference question. and just And the I Darren?

Darren S. Cline

accounts? New

Clay B. Siegall

Yeah.

New accounts.

Darren S. Cline

Yeah.

these to go patients And patients accounts. community. frontline again IV continue the I new see XX% We to back Stage present in of III,

So continue. to breadth nice We quarter. we've that the trend seen during and depth anticipate

Yatin Suneja

right. again. All much you congrats so Thank and

Clay B. Siegall

Thanks.

Operator

you. Thank

Our Cowen. next from Peaker will be with Boris question

Boris Peaker

Great. Thanks great for congratulations a my squeezing on me just me and add let financial in results.

Peggy Pinkston

Thanks, Boris.

Boris Peaker

responsible So for up my the patients just is of prior first versus division? other ADCETRIS maybe or a patients early subgroup question a in any frontline, elderly Is kind maybe adopters the follow subgroup specifically younger there of to question. that's

Clay B. Siegall

there's I to setting. on expand And really Darren, not; really community maybe, it's want do think the I that? think you

Darren S. Cline

Yeah.

parse patient, early too it's type think Boris. of I out really to the

now community. doctors are with what think these know in to off they treating community, they're replaced ADCETRIS. though And with And I seen do they doctors age these the the that some diagnosis right patients of in of I average and have come XX earlier ABVD. is – the think from the races. we bleomycin is again the And present we've community

move we forward. the see And start. so with But we'll we're as pleased

Boris Peaker

EV urothelial. second my in And question on Great. is

response failure Just certainly rate curious support or need meet accelerated in to a what the is setting? overall think rate you post-checkpoint to inhibitor response duration that approval you'd

Clay B. Siegall

sand. the in line real no is There

We as in EV. know you have BTD

regulars liver have a would importantly objective had We lot, had drug, this had program. we with going discussions lead-in there trial, And objective FDA patients is response. XX% some response our a I out on pretty and it's we with and lot in XX% So a with met. hefty whole in other a point

eye-opening. pembro. between with ORR setting. approval nivo, similar PD-X depending. in It was atezo, them setting And was was mentioned all a But really, based XX%, think, of others. That or And that's in to so with there was And couple I and XX% a five XX% the on XX% XX%. then approved. of of PD-LXs you got the XX% to XX%

response. with are trial seen XX% have that data So checkpoints. And our patients these objective substantial we're back with lead-in with sitting

durable afterwards, single-arm in is it's patients. a why we're model. single It's which rate a because a we're response agent at strong looking monotherapy those trial, getting So

think So the FDA that. us we I I I don't good doesn't data the sand. as we give as don't need believe to But approval. have know line in get

Boris Peaker

you. Got

for taking you Thank very great. much Well, my Okay. questions

Operator

you. Thank

will be Andy from next Hsieh William question Blair. Our with

Andy Tsan-Yu Hsieh

on for you my a congratulations Hi. and Thank you team. spectacular question, quarter taking and to the

fact – ASCO, to opportunity. at has Clay, this in do the that forego with And and to DLBCL think So back company about talked decided the XXXX believe, you because opportunity, frontline I that that I that, I field I particular kind in the that in opened changed has become your calculation up. failed setting, ibrutinib has maybe crowded. Has And believe, the setting? of given market that

Clay B. Siegall

in thank thank the ADCETRIS. we DLBCL, the we in DLBCL First of and you for on question all, When you for with look at ADCETRIS back coming are the comments, – guidelines. for

There use in And our in it it's is we NCCN we're the guidelines. while time. And label, setting. and get not is So the all in We in from hear used there. growing that Guidelines. doctors use

may the years like it when they in periodically. you gone series XX a for now. in it they And – these at This field of an get it's these use clinical they'll it. not outlier out is they all CDXX, now for come things field have ago, So and kind I'm every And CDXX not that is pretty day. doctors commercial use But are talked CDXX screen and with to didn't. like standard be different in and centers for in of lymphoma, you others. doctors out you lymphoma, screening confident the some they I've DLBCL. But the even reimbursed group And

in – that CDXX-positive They use. gone who need they they to through and know that use a And the to And see they like objective they Rituxan you've know a And CHOP it. if XX% setting. Rituxan the it docs to this drug is can And lot. some so there. And and XX% Rituxan talked regimen. I've say, they response and you're ADCETRIS

doing little think bit. trial big setting to trial. comes So four-year randomized to a – expensive a economics in that a the a question very And setting a I do need is pretty down probably would we in

so financially the it is, question And it. worth is

about since really a lot give that's we getting NCCN a And what's I'm use But talk consideration you of set this strategically not financial we promising I can't So under there are anything. But something answers Guidelines. point. at and it's internally. the

Andy Tsan-Yu Hsieh

Great. Thank you so much.

Operator

Thank you.

& will Our next with Messer Chad Company. question be from Needham

Gil Blum

question for moving a E-X to is again, guys think with the overlap Chad This relates physicians the potential E-X that Do expansion. expansion? Messer. spectacular quarter. Gil have My And ADCETRIS for using congratulations forward there the Hello. might Blum you any you currently with be

Clay B. Siegall

expansion? Did you E-X say

Roger D. Dansey

E-X. Yeah. Yeah. of Expansion the label.

Roger D. Dansey

Okay. to Roger, take you want it?

Clay B. Siegall

lymphoma think Well, are docs lymphoma I docs.

there the so want do particular isn't you And likelihood overlay. to that make... Darren, is

Darren S. Cline

Yeah. some No. that. can on I add color

a community in good some clinics, setting. patients in transition being be in I really current there academic those will that the you'll about in setting, to a these an we little data, the think, see the lymphoma patients. frontline docs T-cell academic, much think, are treat I we again, I with treated will bit the see And think there's of particularly like overlap. community. big could XX%, that of I E-X, XX% others think But focused And academic have the center, of

So that's the about how thinking we're opportunity.

Gil Blum

So ADCETRIS? you're – expecting you the docs continue that can already using commercial are the expansion with already that

Darren S. Cline

Yeah.

on I'll in account actually comment our further. ECHELON-X When expansion, for territory the we expansion took a that sizing. and So little the did label into geographies bit we

for So can we it. accommodate absolutely

Clay B. Siegall

Right. Yeah.

So about thought – the about I'm understanding I talking more I opportunity. market guess, you're

We shape feel reps call our are and this. the docs. of sales the about talking mean expansion the in You're great know we to number We do and in docs. I this. do we our on ability to sales reps

rate bigger absolutely and I we now when then, regulators come there going we're this. since going ready strong, this on And to are to unmet out hop submission know it in standard lymphoma be need cytotoxic We to our the well. But care is of higher in because of T-cell going was only a toxic if based And actually top you work cocktail on of through CR that course. We're and a go. data, Hodgkin Hodgkin on think the is are as see our medical to data in to we're lymphoma. than had CR pleased doesn't in although it's T-cell rate, a CHOP In lymphoma higher very a the X-drug way bleomycin. than cocktail lymphoma with X-drug

opportunity need. So get I think there's a to bigger the market into a of uptake because very fast that

all Seattle to excited big And it. it close there. all think we're real trying is I And upside this on So depends about very data. our We're a getting for Genetics. opportunity to get

Gil Blum

Thank you clarification. very much for the

Operator

you. Thank

Meacham question next Barclays. from Geoff Our will with be

Jason Zemansky

where adoption Jason on the have know adopters Geoff. Thanks guidelines the North in. so us include is be an docs to be a of comment, guys. kind and do distribution This anticipate just might updated both have Thanks I you community Real when the for the for owing it data extent, you you American early cohort? of much fitting what Hey, think so will to to adopters? difficult bimodal are do late regards But call much. versus sense off but E-X And Zemansky earlier to your with or quickly, predict.

Clay B. Siegall

for you that Thank question.

in continue we'll Guidelines. been as more many going rethink have has – of NCCN dataset. forward have we We to And types different ADCETRIS

these hard give not that something that's timeframe. NCCN a the you it's is Guidelines. to So FDA, are predicted This

when This right guidance providing do. I the haven't will from because assessed is we And forward. – the thing to so historically, doctor and going given it's doctors and here's the vote don't think happen doctor say, to making of that votes groups

you're So really good that think question. though asking a I overall

We into have can and on the our on eye guidelines how doing on can this. we we best the seeing working get right that. data We're

thanks So question. for the

Jason Zemansky

to limiting or? do – that's or an driving think E-X? that's lack it of either something again is just you the uptick the guidelines And issue of regards Great. out with Or else

Clay B. Siegall

as far. NCCN I more we but on We of We'd would and way a And don't think we're – think – love uptick the Guidelines any day, have to data such to data that the commentary hurt what American to this more happy North us. we so do have bigger look forward have with that give very I data. will in when. a But not those there. I guidance want there. you love data the to in

do comment? I dramatically. think will Darren, help you it us pretty to want

Darren S. Cline

think a it's Yeah, no, don't I barrier. been

I the and think adopter question, late what early was that that transformation. versus your

as more take got And set think consideration, the take physicians a when get bit the there'll early. be continue to of they our a folks we'll just past are ability that external reach to on things trial. And I I we E-X more basis, full that they'll at over the with frequent data within to We'll articulate And data experience our the get to time that like the ADCETRIS. little time. you U.S. that North will adopters. American think later look into the

think I we And couldn't of be the look as year. – remainder stated, not sprint. a a to this will our so executing we this with And And forward we've more marathon, is the pleased start.

Jason Zemansky

much you really Thank the Wonderful. color, it. for so appreciate

Darren S. Cline

You're welcome.

Operator

no showing further in questions this time. am I at And the queue

Peggy Pinkston

for afternoon. evening. everybody thanks joining and operator, you, a us Thank this Okay. great Have

Operator

Ladies gentlemen, today's concludes this and Thank teleconference. you.

You disconnect. may now

Seagen (SGEN) 26 Jul 182018 Q2 Earnings call transcript