SGEN - Earnings call transcript Q3 2018

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Operator

Good day, and welcome to the Seattle Genetics Third Quarter 2018 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. Ma'am, please go ahead.

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 Dansey, me Commercial. Simpson, and With are Cline, Chief Officer; Chief Darren Financial Todd Executive Officer; Vice Roger Executive Chief Officer; Siegall, Medical President, President and

our Report filed information performance we XX, Commission. Form pharmaceutical under June Seattle open Quarterly to line Securities statements relating will and and ADCETRIS the Genetics after in vedotin. developments XX-Q development the conclusion costs included of including that future If milestones, in may tisotumab revenues a implied regulatory achieving statements. today, and ended about sales, sales factors be vedotin, is the for for the to XXXX data quarter XXXX, enfortumab the those associated all caption expenses; process. materially call. and include we'll to anticipated or the uncertainty the Among on the with operating company events difference regulatory uncertainties and approval and the of in outlook the call these future timing company's results More and or revenues, may forward-looking future the expenses, are such Actual available and regarding contained clinical cause ADCETRIS, vedotin, as and projected from unable get forecasting the risks remarks differ those, the forward-looking among the tucatinib, faced by with ladiratuzumab Risk financial published Exchange difficulty will Factors or such XXXX Today's of prepared and questions. Following and to financial company's others, fourth the we your include conference questions, potential the for and quarter anticipated company's future and

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

Clay B. Siegall

in strongly and This Thanks, and good us than has several more positioned progress delivered everyone. tremendous milestones. made on ever. afternoon, XXXX Peg, We've significant

old care. and a in where to of standard launched we approval we ADCETRIS, XX-year frontline are lymphoma providing option treatment a new received For Hodgkin replace

produce In in breast is our vedotin lymphoma, addition, of cancer. enrolling urothelial a the from making HERX-positive in our into sixth in the top-line advanced E-X We We've late-stage arm. ladiratuzumab portfolio, of of pivotal phase bring we on several consecutive for our T-cell of we'll the cancer, in XX% advancing cervical peripheral to becoming for year. risk trial rapidly multiple ADCETRIS clinic results. toward update a tisotumab pipeline, We're significant multi-product enrollment pivotal in ECHELON-X company. reduction trial progress reported In novel you trial ADCETRIS-containing cancer. showing trial we and agents positive the results as upcoming our trial activities. pivotal the clinical recent vedotin. progress pivotal death multiple ahead we're earlier-stage made were In continue the we a expectations of Today, trials our we tucatinib trials programs each in and to into key X enfortumab in oncology completed vedotin frontline goal

advanced third strong included March. Canada, ADCETRIS ADCETRIS of second grown rapid year-to-date, year. which in quarter U.S. sequentially AVD approval and adopters lymphoma XXXX. quarter than the reported up each plus revenue in sales of This record and in particularly Hodgkin uptake saw early the a last We've to For frontline compared we net period by quarter same we XX% the more following during ADCETRIS in

to ADCETRIS in an long-term growth this blockbuster key frontline trajectory This shift patients, PTCL; in XX% a to with component top-line is the regimen ADCETRIS specifics million. ADCETRIS-containing in for physicians more trial. and, over We sales States. overall becoming meaningful advanced $XXX full net of paradigm $XXX growth the increase progression-free data $XXX for be reported this remarks. to care the quarter range confident his We is million XXXX One commercial data the our and result future which We're in and XXXX. fourth an phase a sales survival is of share approximately and project care Canada ASH. we would remain on during clinically provide based standard achieved Hodgkin groundbreaking lymphoma believe activities results significant entrenched towards million, month, of $XXX from U.S. E-X on from We at standard X to ECHELON-X survival. will brand take the treating of statistically of our benefit will million over in patients excited of that For many importantly, Darren the time. treated United the positive earlier the are

the Given FDA in supplemental the BLA data, expect the with discussions had – of we plan strength we've submit to and we November.

Recently, In $XX Japan submit on addition, in frontline in for Takeda territories. This Hodgkin payment milestone patients our received a lymphoma million data option ADCETRIS as Takeda partner us. approval based plans E-X trial. a authorities triggered CDXX-positive to for to treatment its these the regulatory to

In on part investigator-sponsored are mostly and lymphoma Hodgkin or ADCETRIS as trials company addition, evaluating of ADCETRIS EMA. – in involving lymphoma lymphomas. are XXX regimens, Hodgkin than frontline including globe. around previously trials and the Takeda trials Hodgkin ADCETRIS authorities, as submitted more several to applications lymphoma, These focused AVD completed earlier-stage There and in untreated combination the monotherapy relapsed ongoing combination for B-cell including with other approval of involved both

a data such are LYMPHOMA, support or pipeline. potential published complete foundation to these of strong year, which refractory parallel our example, as goal in ADCETRIS we lymphomas. remission. and ADCETRIS in We're showed regulatory For franchise, earlier we including from a ADCETRIS building advancing of the response expanding interactions In data reviewing XX% trial this establish rate, plus could XX% as objective for our Hodgkin which bendamustine further therapy the CDXX-expressing with relapsed

to from accelerated locally trial In we with support pathway. enrollment report we Based completed PD-X EV, or PD-LX we for XXXX. or will EV-XXX aligned govern enfortumab the cohorts or who Astellas receive top-line data Our XXXX FDA's in FDA pivotal metastatic in specifics quarter progress with global first the under patients of platinum-based now the chemotherapy of EV, how a agent the launch regulatory could urothelial pivotal anticipation a of its EV collaboration developing of a This inhibitor. commercialization. and of in vedotin, We're advanced In expect approval to-date, and the most July, advanced we Astellas. submission trial approval potential have both cancer. on program in is on

Canada will the share believe commercialization plans. sales be of high clinically for HERX the global best-in-class. tyrosine book profit share know, the the jointly which with Astellas worldwide companies rest on of kinase book program its are is each without will toxicities. this you Americas, oral the tucatinib. companies and As parts patients once royalty affinity EUX, Tucatinib utilizes working States, United XX-XX contemplates XX-XX HERX help small that and bring inhibition other the approved a molecule world organization, best advanced in The TKIs Genetics the meaningful In EV will portfolio This we significant to could profit Seattle territories. with EGFR, profit may while marketplace given that our structure the believe next in in individual territories, position share. a rate the most is and of is appropriate The approximate are EV Other differentiated strengths from in to of We rates world. an and inhibitor ensure need. can designed of reduce we sales,

cancer, including primary XXXX. Our of complete in with supports brain HERXCLIMB tucatinib focus the HERX-positive early metastasis. with metastatic patients endpoint we or analysis without the This of HERXCLIMB the enrolling ongoing and is expect pivotal to XXX primary is of trial rapidly, PFS. enrollment target patients breast the in

analysis to patients. is up the year. communicating FDA, this In we patients key result This strengthens secondary survival our the This with plan are PFS which enrollment our earlier XXX the of overall now evaluation Cascadian metastasis. addition, following after the acquisition change the of trial in endpoints continue with brain and of of to

anticipate enrolling, by HERXCLIMB of is submissions. HERXCLIMB XXX accrual rapidly how intended is completing global Given regulatory we to support mid-XXXX. patients

breast call the gastric as At tumors, of well plan to cancers. earlier as also We into metastatic other as such and I'll solid point, expand colorectal tucatinib HERX-expressing this lines in program cancer, on our the update provide discuss to results. programs, Darren clinical Darren? to over commercial turn our then will an Roger will activities. discuss Todd that, quarter and After financial third our

Darren S. Cline

second Thanks, sales in were Clay. increase a of third million the quarter over XXXX. quarter, ADCETRIS net X% the $XXX

the market a the classical have with our overall HL. and III we're launching We In and setting, frontline care. IV We're Hodgkin XX-year-old lymphoma understanding are six progress Stage a good standard of of launch ADCETRIS into in the pleased or displacing months dynamics. in

saw We who benefit year-over-year to plus noticeable was the regimen. this believe sales we in in of particularly the ADCETRIS growth among adoption First, greater QX. physicians the rapid contributed and AVD than XX% appreciated

entering talking provide, patients, integration treatment benefit our This we're supporting is about phase into ADCETRIS of the connect community broader pathways. and continuing the second and publishing Now use. focused involves which on the launch with the of physician that can to data ADCETRIS

team stage is this The priorities. launch. the three quarter commercial guidance fourth Our focused the of on for reflects key

the additional of and prophylactic free to efficacy Market can in support We III the is and particularly desire sacrificing future. physicians use setting. the our where treated. are to in continue factor the frontline to American patients in a evidence were with published These data subset plus safety expected many we growth be familiar newly promoting near dosing with boards IV frontline presented that indicate community provide are patients. recently advisory physicians in compelling the to working Stage and with HL settings provide ADCETRIS team North diagnosed and ensure which outcomes at strong is AVD without patients bleomycin research to data, majority regimen a and those the that June First, diagnosed E-X ASCO started field superior are estimate in data HL

Second, we to to ADCETRIS the ensure along appropriately because want pathways treatment is around We guidelines that on AVD progress. diagnosis plus affairs in included ADCETRIS to care setting and replace the that The are AVD data. commercial see that And our in their standard we've keeping online. to team, advances plus guidelines. patient This look centers academic ensure engagement efforts confident we colleagues, on patients average and consistent increased HL patients some uptick advanced to of approximately the years. HL in our will XX forward care. of website. in medical lastly, apply to educate diagnosed and in We is and seek updated important remain physicians physician The age continue is ask and groups XX-year-old our utilize These continue with HL with you and our newly patient to want patients traffic out caregivers an our familiar they for about frontline physicians ADCETRIS. information and pathways

are patients is CDXX Looking a our treatment, in a patient need underway potential confirms PTCL preparations ADCETRIS the therapy for approved, substantial significant lines benefit plus these expressing a many CHOP frontline to frontline E-X PTCL addressable ahead, the chemotherapy approximately from will of that an ADCETRIS patients care is based indications. expressing patients strong if current We estimate where believe and unmet suboptimal. ADCETRIS annually. of provides results population across and in on standard opportunity. PTCL approval to represent research of CHP of Market US the trial. X,XXX We high diagnosed launch CDXX there the commercial newly in benefit chemotherapy, and

to Our a is brand. blockbuster build into vision ADCETRIS

continued the vision. be frontline will our clinical setting I'll major approval frontline the to drivers the activities. achieving the turn discuss HL call and in potential launch in over execution Roger to PTCL Our now setting of our

Roger D. Dansey

events And good a of activities recent highlight afternoon, the as development I'll Thanks, summarize important horizon. well Today on our Darren. clinical as some everyone. few

enrolled ADCETRIS otherwise including First standard mentioned, PTCL XX% PFS as significant ALCL, in results statistically CHOP the representing T-cell common frontline produced not a The arm patients, from of other the with XXX to the a ADCETRIS we in non-Hodgkin containing reported progression plus chemotherapy ECHELON-X CHP Clay for comprises compared subtypes. primary in The specified risk PTCL endpoint which ADCETRIS, a systemic regimen. the Phase of in reduction trial, ratio hazard events. improvement of PTCL. lymphomas trial X.XX, E-X less a X positive of number

ALCL, All for OS other Importantly, show this of significant overall key an trial ADCETRIS CHP. in risk remission PTCL. X.XX PFS and These safety frontline we which comparable these XX% benefit practice the reduction statistically as rates E-X combination ratio The Phase CHP with CHP survival significant with statistically plus overall well of of the view in rates in were response improvement in also was to a profile the death. to to complete of systemic a the ADCETRIS ADCETRIS first established was and hazard observed secondary profile favor with We in entire The plus data randomized in outcome as is changing. arm. ADCETRIS X equates the population. endpoints with patients safety plus CHOP potentially consistent chemotherapy. as included

PFS diligently As to Clay of mentioned, that strong data as company in containing one expressing this upcoming meeting. Symposium clinical presentations data under presented patients lymphoma. five-year tumor from outcomes at The CD-XX and nivolumab on also in in during ADCETRIS look include Notable frontline positive review abstracts Diego. the Hodgkin a and to following settings, forward in relapsed Autologous include showing abstracts we're quickly from ADCETRIS sessions for the presented ADCETRIS XX we ASH as of well data both for in and be as will will clinical Transplant, a in December. data Germany of types at investigator-initiated working get both variety expect trials ADCETRIS we promising ECHELON-X data being Hodgkin ADCETRIS high FDA possible. E-X the weekend more than several San combination is are and treated International Lymphoma a with as and risk

Hodgkin important G-CSF lymphoma achieved the efficacy on with vedotin who enfortumab safety EV. a prophylaxis with III trial from initiating the ADCETRIS outcomes trial clinically patients and trial Stage X improved E-X now better generate to IV data The we will a use are findings expanding treated which on prophylaxis with subset or Phase or I'll profile. G-CSF the safety our Lastly of of in primary AVD. year patients this received to for ADCETRIS, plus assist primary move

trial urothelial our indicated, Clay locally other like in EV or on comment is with advanced As priority highest metastatic ongoing I'd our the activities. development to pivotal EV cancer.

trial the patients to cancer PD-X Phase X as with inhibitor This EV-XXX in the is who've global with to containing First, metastatic for EV, and important either submissions confirmatory is randomized platinum trial regimen a a treated or EV-XXX States. serve an ongoing. called because as intended trial well a support previously PD-LX United been urothelial regulatory in it's as

setting beyond believe evaluate current is line treatment companies that cancer The of a together role which going landscape from plan so this results first trials combinations inform strategy we urothelial line more of registration to Data other of Cisplatin or from to of are our An will carboplatin, frontline agent, platinum PD-LX forward. with exploring combination and the together broadly approach trial metastatic expand EV EV has evolving multiple care. the standard incorporating ongoing agents line part rapidly. to PD-X, first this EV with in example of combinations evaluate We pembrolizumab. this our is first EV-XXX trial in expanded

TV with tumors. array Now vedotin tissue in to tisotumab wide or developing of we're is factor we'll targets a solid expressed Genmab. which which TV turn

trial are trial pivotal neck that and evaluating plan is trial the and These Phase tissue on cancer on cell FDA support enrolling to TV non-small focused initiate has designed to expressed. where in factor tumors TV accelerated We to is cancer. approval cancer, We're include regulatory head a pancreatic, colorectal, currently basket lung pathway. also of we a also cervical X and cancer other a solid enrolling ovarian and a submission

its triple are cancer. targeting LV reported ladiratuzumab which highlight continuing briefly monotherapy vedotin explore TNBC look address we we're and a But are updated the more addition to part cancer negative in with near unmet in combined an is combination LV in of We've of program who to evaluated trials in to breast ADC you metastatic the on failed previously heavily as triple negative LV potential together of LIVX breast as medical and patients several encouraging and has and like are for as the perspective, been part LV is being trial. pretreated, atezolizumab trial. I'd with also breast single or the LV we ongoing evaluating From patients in keeping in one X I-SPY activity adjuvant or the forward cancer. evaluating who agent MORPHEUS pembrolizumab, with lines therapy. We to need Next, LV setting

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

Todd E. Simpson

quarter $XXX for I'll the first third for in and Today the Thanks, Great. of financial expansions outlook updates and $XXX year. in This our results Hodgkin included Roger. nine third the U.S. XXXX. And in the the for provide everyone, of Total million Growth months us our for the third afternoon. million million call and in the in quarter the in this million revenues on year-to-date quarter were sales the $XXX the as year-to-date, some to well ADCETRIS reflects were financial as label for and year. the thanks, CTCL Lymphoma. net joining $XXX and Canada frontline XXXX recent summarize

As Clay U.S. $XX increased quarter million fourth in million. XXXX. compared quarter in ADCETRIS net of in guiding the third to Canada the mentioned, of sales quarter million $XXX $XX we third are million and to to Royalty for the revenues $XXX

year. approval to royalty million the to for collaboration revenues amounts portion This triggered Takeda XXXX $XX for ADC $XX third lymphoma. Collaboration earned in million increasing a months of million Japan earned ADCETRIS strong Takeda, we were ADCETRIS our nine Based $XX milestone the includes in by the and $XX frontline our from of deals. compared Takeda, on by quarter million Hodgkin of the which XXXX, were included revenues revenues range royalty under with our $XX for first to period $XX the For sales a expectations million are last million. of same

expectations for $XXX quarter launch expectation are support the quarter and to costs nine Hodgkin XXXX on $XXX frontline the increasing R&D of expenses quarter to million of million were million acquisition our increases year Expenses year-to-date million. narrowing the $XX a $XX for million we portfolio. our we of the in XXXX the across expenses in in $XX of are in commercial higher million. $XXX over expenses SG&A Based to to a range months investment year. in reflect $XXX XXXX our As collaboration for the results, reflect third a result, this million R&D Lymphoma. our $XXX first revenues the third XXXX range first The and to-date. to were in of ADCETRIS Cascadian and million of

market stock Given results in of our to our for the are to to $XXX $XX the over $XX million. financial $XXX $XXX addition investment Immunomedics. this the year These net continuing guidance gain million. portfolio, investments. for the loss quarter turn core during I'll slightly XXXX million be the back variability not ended approximately and investments Of contributed note, for million and range cash support shares for SG&A quarter to which in with we an mark call year in to our is our of is a common operations. to We million in in This causes holdings and with our $XXX expenses of that, the third are And Clay. million to to increasing in

Clay B. Siegall

reporting frontline supplemental the Thanks, several in trial to months. summary key November milestones at Todd. E-X ASH. close in with in from data the first, next PTCL, I'll expected include, BLA a They submitting the and of short FDA

Second, from pivotal trial, reporting in the EV-XXX, cancer XXXX. first of data quarter the in urothelial top EV line

tucatinib cervical breast Q&A. positive in pivotal in XXXX. to have the revenues which company. pivotal call this of the Seattle advancing brand open in vision to the the trial Genetics advancing open ADCETRIS patients enrollment cancer. we $X.X a By we'll metastatic and our completing TV U.S. for the the trial late-stage XXXX of of continuing in XXX Operator, point, our early is lastly, please potential Third, pipeline, line oncology HER-X into grow realize cancer questions. approaching and global multi-product for transforming billion And HERXCLIMB in At

Operator

right. All sir. Yes,

will first Michael come Our with from Guggenheim Schmidt question Partners.

Michael Schmidt

share been a just dynamics on Could Clay. the a bit help you And in has III/IV follow-up. had And couple. the little population first had ADCETRIS market in I of then one Maybe Stage patient my in so ...taking questions. Where line first could on what understand setting? the far quick uptake you point? I ADCETRIS, comment us a strongest Hodgkin you the sales more at have percent this lymphoma?

Clay B. Siegall

question. Sure. Thanks for the

this So doctors $X on well. a to overall, billion said $X.X brand Michael, prepared an get globally. very approaching great really starting billion And U.S. like it's as ADCETRIS, we in to And doing in it. I product, and closer depend remarks, at look product, it's important is

grow to comments adopters, do and there make regimen rapid share. lymphoma to continue the early from regimen, you uptake the from get to want standpoint lymphoma Hodgkin that up frontline work into Darren, had about variabilities hard work XX%, we're the now year-to-date or We've hard but are there? market we're Now out diagnoses to the any doing a a market. quarter-to-quarter we E-X we got Hodgkin begins. in Clearly And

Darren S. Cline

bleomycin-free Sure, really rapid physicians regimen Yeah, of asked that about and quickly. Michael. And knew regimen. research that market were adoption we took camps issue that was toxicity the one a you Thanks those going really see It their discussions patients. the for pulmonary to docs looking question. of and we in that bleomycin for that kind with a two had our the frontline all

is that curative took second the This ADCETRIS and to were plus that showed disease benefit. just physicians The trial and the ECHELON-X data. AVD intent, that just has

And are the that quickly pivoted physicians so to the those product.

of majority patients a we Clay year. where changing now, the of mentioned community four XX-year three see diagnosed to now take these to some pivot these physicians of in a me remind standard kind And as care times. let are Now you, patients

the which of representatives physicians, particularly roughly data, educate data North highlight highlights XX continue So North effect our American in really treatment a American our the to sales force experience. nice

of super forward, So hard to work do. optimistic lot we're a moving

kind a that It's for about we'll but determine away get from we on where ask shore, update little is did as to share early progress farther share. our you of there. us You

Michael Schmidt

one then mentioned you patients XXX enrollment trial side? just change, that I Thanks. based overall analysis, the quick just on be done if that on and change, larger first will wondering was Great. is on HERXCLIMB, now the primary triggered And PFS the a the the protocol

Clay B. Siegall

still the is XXX call. off PFS and triggered XXXX of scheduled the the patients, that's have on as early Yeah, we for mentioned

So patients. still XXX at

Michael Schmidt

Perfect. Great. Thank Clay. you,

Operator

Thank you.

next RBC Our will Markets. come with question MacKay from Kennen Capital

Kennen Mackay

for perhaps could there a were maybe saw of frontline just through we question, Thanks a a cycles clinic ADCETRIS. ECHELON-X? coming increase, you little Hi. your the QX understanding thanks color taking the for wondering Hoping a duration question. Clay, so referring between of in in that Darren if And us these. some just what XX for did factoring was commercial like on seem seems of seen that the Hodgkins. maybe you in I that warehouse sales the in getting know diagnoses. It on, help patients especially for give seasonality really a little one trajectory the was taking elaborate Is that's kind Maybe to were here. quarter-over-quarter. of understand it like And price not when if I Also of hoping QX excluding the inventory Hodgkins flat here on that us more can it's QX, lot sort and Hodgkins? QX. looking of out dynamic of ADCETRIS Maybe wondering then question sense into comment in and final you going or bit on the given wondering bit the can launch

Clay B. Siegall

don't why you Darren, in afterwards. and start hop Yeah. I'll

Darren S. Cline

got So dynamics Kennen, I thanks for duration. the the question.

of rapid saw in took I uptake to some notably therapy that but you which we were therapy, ADCETRIS second the those I really and mentioned as is year note the typical I think first stocking. And physicians in that as is half launches. yeah, And not So there any did is in most a that earlier, really the noted, quarter. really, the

of or and it Genetics. just-in-time it's Physicians receive know, ADCETRIS next a clinics day. Seattle delivery it from order you As the they

latched frontline gate, care educate the of adopted the out onto data. of the was indicates physicians So area we do really for entrenched physicians dynamic just those research kind ADCETRIS continue All standard in American a of our market about particularly of pivot now and North setting. which our the it's we plus We're around. really that that AVD that tat to to physicians not XX-year compelling XX that representatives optimistic data, have it, in

So, we're educate excited around dataset. continue to get to out there and that them

and the duration, shared say much like that it and just time the months growth factor, what in duration docs understand our We're to in intent our several Regarding setting. is need what with duration therapy update on relapse really the into of refractory And so all AETHERA, into too unlike is. a patients that this do early. get I much as patients are launch indications we (XX:XX:XX) is, that at appropriate we'll possible. But you labels prophylactic previous is and these as curative want and therapy docs want to frontline cure to will

Clay B. Siegall

came crossover big ABVD that think on over great first were into and ADCETRIS and for we or some cycle partially row. crossed I get had. did then when out that a burst quarters two already patients regimen, add a I'd we two in added with had to that that AVD, So to this We we the

the so as down you're And because crossover giving well. not settles that

of strong. we this Darren curative going some are be – of great, something on the the there. so see because four of to or some patients cancer a we three think that duration, takes a lot of year. out don't answered Doctors this duration is – see to lymphoma – in question will And just time of using and this is not get the intent. the community did it doctors doctors is We see it So is a that. think there's Hodgkin really it's in hem-onc And XX-year lung and is them doctors, regimen thousands

a just good disease so and ABVD And our is using if been used they're you ABVD. a increasing American because survival And chemotherapy data, XX% has into we're get thing, it's by the quite rate this And long-term their to been North is bleomycin. success mindset, look at without has to bleomycin toxic. but story, free

data to we that feel they up canvass think strong. start will as – doctors to ways are data, it very use to doctors, are take Darren our even our use set the in are it And And their future. doctors So so they I we and starting see about good and talk it. that

Kennen Mackay

follow-up you. additional Got maybe Thanks, one if could. I And Clay.

study. wondering you little was the to bit to a help a were of events that little is us seeing or OS more cumulating? could that event on If bit you Just in PFS sort hoping decision? initially related for of HERXCLIMB more, sort I just color rates understand led it changes specifically the this to the what

Clay B. Siegall

Sure. to wasn't related really events. It

Let the reasons, very rid step increasing EGFR a Cascadian. get incredibly could just relatively for really interaction acquired like connected acquisition. drug. so toxicities back second. with if this we It We strong tucatinib of that strong a type of for The of well. went a HERX, are interaction any We me was lot with integration none with

all. okay? patients up the the we very able come And not trial. patients is trial we we're trial. the of can mets, keep OS. go that's to great And and interested in, brain XXX so at to really to we that in were And were have in the PFS, review changing And like able half to the mind to But

extra it's us been few more And it'll all fast, increase and barely time, an OS even the XXX to to exciting enrollment have patients. important is sample an data okay, we treating the enrollment from size, – time. our months and for patients. statistical to really earlier It continue done – them that this so like due make we just to and having really the doctors the we a patients, increase this OS, an that, has we'll and OS I mean, takes sure by potentially opportunity – power more hear is to So to which getting have time on something

sense. made and We have And is to regulators you so sense. Roger, this any spoke with total with this to us were regulators us this So just do fine made – totally it additional color? and

Roger D. Dansey

No.

trial significant This Clay, move value the trial. right. for for well-designed increases two the secondary already this points It's size events. on producing outcomes end primary and the those you're its think, increase end the hit the of and I strengthens points, two potential sample to to just a exactly

Clay B. Siegall

is or And the overall is has getting stating so hit because going I'll mention shortening to will be now – the the were year in that done patients stating thought. that XXXX. thing we're something, one of early and middle initially Yeah. data in timeframe that to enrollment more we're saying the XXX now well so than XXX data on the The earlier come patients, the we're we

Kennen Mackay

color. you and you. additional for the Got Thank questions

Operator

you. right. All Thank

will question with come from Berens next Andrew Our Partners. Leerink

Andrew Scott Berens

going acceleration us on guys. Hi, you Was contributing if be question. of can quarter-over-quarter? slowdown what be dynamics the forward? Thanks a reaffirm wondering growth taking done give And prescriber some appears the to for to color the is maybe that to unique could what then

Clay B. Siegall

cure in, higher regimen disease think we'll Sure. Well, XX-year came that a even free doctors using say similar is cure have hesitate long that survival. for usually We to this a sure. we've to defined because already. high this we term I up be a We with and it tracking it's been cure follow have made call fairly five-year to rate. a that comments

is enhanced represents that no doubt strong, are wait have We'll most little benefit rate. So cure it data that There about is a it and to where just patients likely use this something to bleomycin. word. But can longer our a okay? without it

decades time that. able we doctors the of to do For were in first trying

being of these think only become getting ADCETRIS CHOP with against is data in also there's frontline a And if we will help out doctors old frontline see just not not ADCETRIS same CHOP, And ADCETRIS effective and And then PTCL they're they were think about ABVD. is to regimen want diseases, not so the they there E-X and I patients. and near help for as – nowhere in think that thing decades will and this. them. just something treat it's that point these rate at to its these about docs They doctors it's But because really would Certainly, The that the difference hopefully like see it ABVD many pathways getting once regular again, the their is doctors practices goes and with cancer. are doctors – PTCL. think on They're they same get the cure also it that some because ADCETRIS other future, not old there bunch CHOP certainly, decades this to as doctors and is put in together, for getting E-X thing so frontline the that a a that high they Hodgkin not they're similar decades and lung get there, out approval doctors approval of that E-X, the ABVD E-X and is the regimens. we don't on used know fast and Hodgkin, using into mindset thing. And quick are and the that old. to needs really that's went a which the used lymphoma

And of have Darren, to really and more both ADCETRIS them into both those think additional having there you so get do connecting the will frontline and comments? two. out mindset any I the impact

Darren S. Cline

to book-to-book, ACP data an patients to well, at. downloads our and around our voice, that extremely Yeah. and caregivers we digital of Andy, your you therapy, the prescribe, traffic are North increasing, the which are are exactly the detail, look the on them ADCETRIS some the right. look on digits, research I of us for time when is metrics AVD force this to were looking market knowing in frontline But of is physicians intent all telling different metrics our our when setting. compelling that outlined at our to adopt our And are and American to plus about think look share market part sales it Clay increasing. we double that physicians that When patients important get the all shows then patients, think impact – research looking at this treatment our just and that metrics it to I execution accelerating really in

and the you fourth year. frontline those PTCL. the into with And quarter out, we're III see really patients Stage Hodgkin, early potential things ADCETRIS E-X, frontline next pointed approach moving also, as that excited or frontline So are of both in a Clay about the and Stage IV

Andrew Scott Berens

Is III Is IV? the any any Stage payers? from to reimbursement? Are pushback Okay. payers it on there they and restricting other there

Clay B. Siegall

promote is We our off-label. that's label certainly so in Stage IV, label. and Our don't III

of We at payer all. pushback heard not have

So been not that – hasn't that's an issue.

our plus we those the labels, at think labels I five have. payer AVD no reflect monotherapy both payers, Andy, that in the ADCETRIS any and across of issues currently

Andrew Scott Berens

And just please. one one, then Okay. last

proposals, Just that any changes, drug on how ADCETRIS. affect HHS the could thoughts pricing

Clay B. Siegall

– to or proposals comment have want that. We anything I specific HHS like on don't

price very term we We increases them, underwater sure professional have, kept a as they as they're you know, and modest, it. and taken that never put made healthcare

always them So we've we've And we will keep whether future, modest. we increases take price we on really will do, comment the kept done, is in like or if them will not never modest. we which but

Andrew Scott Berens

a that... to ASP-based also proposal the there's But Okay. Does pricing/ remove

Clay B. Siegall

Yeah.

Andrew Scott Berens

have in ADCETRIS on the ...potentially impact community? an

Darren S. Cline

we will different no I policy, potential ADCETRIS, we'll But evaluate. take currently – and evaluate, have to We contracts – Well, you. we're there's and consider Andy, something all Andy. with in impact I'll that what it, not will don't changes continue those it's so to that I'll pricing contracting just think discounting – and continue have something these

Andrew Scott Berens

you Thank the for questions. Okay.

Operator

right. All Thank you.

from Sachs. question next Goldman comes with Salveen Richter Our

Maryana Breitman

Yes, the about forward? of then similar will I that for Do I a to had have be you've question another like launch shifting expect to some This phenomenon was, kind that early is quick the that taking ask for Breitman hi. guys before? Maryana seen you do going of you wanted effect that you have seasonality basically one. Thanks of Salveen. and think you. guidance. dynamic I XQ question. sort the Thank the it's just And PTCL type adopters is going to have paradigm going

Clay B. Siegall

questions. the thanks remarks, prepared seasonality. Yeah, for the We in mentioned,

little good on share there it's was And a number we patients bit little we something Our frontline our it's said know a the completely Hodgkin looked diagnosed frontline for and less every it we XXX% with a sure, having out if we've And share and our because frontline, XXX% and that patient we is be we're at. be to – have quarter. just fully but done quarter we're share like like to that lymphoma seasonality have details, the in lymphoma hard still that Hodgkin to single wanted hard this because and it's don't could their that and but the diagnosed, less in put the something at word seemed work in we good there was because considered reason. but of there's that low looking share,

that's something put out just so we there. And

early Second the of all, in about PTCL, and you we asked same. see will adopters

unmet of that something. patients is cure because less that mid-XXs, there's so different a ABVD for, rate does medical think a for I bigger CHOP to provide regimen. are doctors E-X not commit I while in does. we know and a to This sure, little don't the well don't know PTCL need want treated the for like

multi-year look but rate, we're with, to that we're excited in survival you're data, the historically, excited a at with mid-XXs. Now, disease-free not long the with of mid-XXs we're very have our like XX%, rate you when in North American disease-free that, more PTCL it's survival

lot with ended of are So the of respond, treated lot that there's well. not even And patients that relapsing PTCL. a patients very a up them

So cure just XX% an a there's CR that's rate. rate immediate not

So be that? color to I think want Darren, to any it's there. do different you going to add

Darren S. Cline

Yeah.

to right, hard we think predict. I it's while – and Clay, you're

treatment frontline – physicians patients option promoting a lot and to excited that see academic with be surprise a And be it of mid-cycle tremendous between our overlap we're force, treating on look a as and survival will both docs some the But setting I and Hodgkin at of dynamic of and is to. some community If deployment in setting. the of remains will think it, to whether making think benefit latch the I switch our is you think – we'll the PTCL, their overall and the the physicians I particular for us in we're once seen. CHP I sales between approved think out that there's do physicians patients. really there ADCETRIS

Maryana Breitman

Thank you.

Operator

Thank you. right. All

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

Tazeen Ahmad

you Clay, questions. called it's my KEYNOTE-XXX study thoughts taking versus wanted plus your the for They're using a study. Thanks just at afternoon. PD-X Merck I is that ADCETRIS to and study, looking I ADCETRIS, and get the Good PD-X think Hi. doing, about that KEYNOTE alone, outcome depending not are general your study, combo this what how could with sales? on realize but do about your in the therapies is thoughts ADCETRIS of impact

Clay B. Siegall

of of they very lymphoma, whether think first is address to way general at general a Well, all, think the what asked combinations do first we you And We're and Hodgkin E-X or not, with all track question, and on which is, The Seattle we this. I are of E-X ADCETRIS both combinations. I Genetics of those. so use all, in aware studies the actually ADCETRIS? what best question do think the

so ADCETRIS approved that. and very the we So in standard we're now E-X. with old and – with well combines we those chemotherapy. that are We know The fact, frontline, school see

we are submit November that. because getting hustling. We is, regulatory cranking I that's medical And our and groundbreaking clinical in I group submission the add, group prepared that and working morning, and but so our writing with groundbreaking, really noon, E-X; we're didn't fast, data, mean, great night weekends. is And in group. done may remarks, data in have We data that make to planning

are We it's do regimen – thing for the patients – to working to quite out patients. the hard Yes, it's right frankly, good this for it's get to darn right company, fast. pretty the but get this to to thing it because patients for

we an that's like presented used could of likely we're – presented this all, on was that I kind a We gave very with with impact trial patients. that And data This data XX% XX% X of data of spectacular. trials. the had strong about really combination. excited absolutely, dramatic case PD-Xs, XX inhibitors it the over have, plus ORR talked plus we substantive And an pretty combinations really and CR mentioned in rate; we a be wasn't not data but And like mean, showing data PD-X, compelling data in have showing you population from a bendamustine over a example ASH, if biologics we in and very a or lot we worth – previously with big of we PD-X the patients it think, at I ADCETRIS We as combining is of over of populations. activity. a patients. nivolumab, that. as Now, most was XX This of it's far PD-Xs, ADCETRIS

putting option. upfront; to ultimately we how data, it's so that when me, and regulators also, talking regimen, an an and been to perhaps was an something could about. ADCETRIS-PD-X treated And agent we single on is second-line or with then all who there be that's with good. Hodgkin or strong a ADCETRIS mentioned past we've in have actually is go goes ADCETRIS whether patient Hodgkin activity our about through And the a that very and for consider ADCETRIS our together – to how there, treated, that the third-line, something we first call of any lymphoma. approval something; you will mean you lymphoma look then And AVD in which subject regimen this are is I checkpoints an ADCETRIS-bendamustine

there's and that conferences we're of and actually was lymphoma, about I there that was treated Stage you'll but ADCETRIS, at we regimens to ADCETRIS to earlier spectacular just it's be a frontline. approved chemo. and are ASH in the which were aren't couple in earlier on because it at last here on but in are lines Hodgkin using so you the with history Stage III and multiple add and see there done early data the using so after the going aren't see patients, and one Stage see remission – are that didn't IV you'll it on letters, was different think yet focused going too If a starting lymphoma and with Stage not and in a regimens change stage, II, few year presented Stage Stage duration may and largely that put make But duration. failed have to so things, ASH the well ADCETRIS-AVD, earlier great of ADCETRIS with the studies different in less of mainly stage ADCETRIS Hodgkin changing in life that combination IV, that presentation I ADCETRIS quite in will less not like using I going complete patients frontline because just left but already that There into checkpoints think I Conference. III – few there's even work we're in some lot of

to XX you people, the look I start they them because letters pretty ASH old, and a different less take years have in ADCETRIS, better. at lot about excited are to point So that, chemotherapy to you chemos, eliminate earlier-stage patients, and the we're they're letters a that to trying think and because get, with of especially I'll kids, young they're

we're so about pretty excited that. And

Tazeen Ahmad

like II. that what population, traditionally the meaningful? one and for thing kind would use Stage one Thanks Okay. a Stage I of maybe in all to very doctors high Clay. cure patient color, improvement you in feel just think said would ABVD Because has follow-up rate it's about you make clinically And then

Clay B. Siegall

try a better a than I But I CR can't it's even CR, me, good get even III could get hard CR IV. good and a will has getting used you pretty into data. toxic and every II, patient talk high rate, ABVD point to you approaching less chemotherapy, if for very Stage pretty XXX% correct. I Stage specific you But In outcome, get deal. significantly that's and to Stage could approach ASH, less start you yet and and about rate, are Clearly, Stage and a

so trying apologize. But you now, what do. that ASH distance. all data far can't the give not And is to we're that's the I I And in

Tazeen Ahmad

Clay. Thanks, Okay.

Operator

you. thank And

will from come Kasimov next Our question Cory JPMorgan. with

Shawn Fu

This is Shawn for Cory. taking question. on my for guys. Hey, Thanks

how testing PTCL a that center hurdle the to for in Just anticipate do already ADCETRIS it officially for might Thank you is guidelines And given indication once be curious, for speed common PTCL, of and terms have patients? of of a need affect ramp And CDXX sense in adoption? is you this how you. for on approved? of treatment do what guys testing actually the then practice, the current done are being sales generated sort the that already

Clay B. Siegall

Okay. one middle to third the someone the I'm to I have and the for. going heard question, ask first and

your So, Is I'll over. the it first second maybe one, here? turn one question just the

Darren S. Cline

I thought heard and I Well, testing then treatment.

Clay B. Siegall

Yeah.

Darren S. Cline

what... know You

Clay B. Siegall

Go ahead.

You can talk about the testing.

that. Sorry about Go ahead.

Darren S. Cline

test most yeah, run. think, I is testing PTCL So, the so a quite and, lymphomas, for frankly, CDXX there

for PTCL in do so what test do for though CDXX. think And on FDA we label anticipate depending physicians we indicates, the that that will particular,

with for engaged that there frankly, approval, around a was around pathologists, have educating CDXX We since quite treatment and ADCETRIS. now

back physicians, to therapy. the PTCL, of all that able we report now the we'll physician And and what the to sure make treatment, are that continue so those a diagnosis to patient's pathologists indication the and continue indicate where initiatives, the the should there's educate an ADCETRIS for part tests, diagnoses, be also is and

Clay B. Siegall

Yeah, This might testing. it I – and on commonly done. the was add very is

Darren S. Cline

Yes.

Clay B. Siegall

key look of to at across they're they're are if things. is that centers clinical T-cell, standard potential and one determine is the Hodgkin, that the non-Hodgkin, if This other CDXX done B-cell, few tests globe, they're lymphomas if at just

this at we lymphoma. The looking T-cell cutaneous other were happened, in thing this is,

just a about. guidance to it's So think

which they we a to own not. it everybody. says screen we and doctors CDXX-expressing, obviously lymphomas, lymphoma, percentage, T-cell T-cell them, on cutaneous CDXX In deciding whereas it's center, screening, in not or but it's their on and lymphoma, patients so cutaneous And high screen in Hodgkin whether have everybody, in allows our label use

be So know but be it says and it label I the may CTCL, what may same, E-X but to in not, that's going it don't in what's CDXX-expressing.

The second question...

Darren S. Cline

– We you PTCL, to. setting we will we the be I for down the get label, T-cell I said guideline but some frontline peripheral over when be do break lymphoma this use physicians, don't some – the we use, the think for but I think seeing all promoting we'll think think and past, now? existing we're

Clay B. Siegall

think are Yeah. see there data just on now, off-label and presented was sales think line we put the say PTCL, are. E-X don't the ASH. I we there data, set, until sales didn't asked sales we I top now in the our would until out about, at When you

data look the really to it that's And don't it's don't is we too see some, They'd like in material, at much. I data to Wall of the the because the – Street, to so may set. goes mean, doctors time top-line data out more top-line full respond. but like think really where I see doctors a investors

where so, come play we question And after now, could your I right into think so. that's ASH, don't that but think

Darren S. Cline

Correct. Yeah.

Shawn Fu

Perfect. guys. Okay. Thanks,

Operator

right. All you. Thank

Geoff comes from next Our Meacham with Barclays. question

Geoff Meacham

new the more I setting? you've community that that E-X. And Hey, E-X in I guys. on follow-up higher think this lessons could do I call guess Thanks you a joined has been asked. implement about tipping impact, what if thinking the for is the prescribers learned so late then question. Clay, But on broadly? that the are volume, have I'm a the sorry point and you

Clay B. Siegall

did quite imagine. are yeah, on, We and, as get we a questions out you can there few early

American there We docs, force in our to are talking talking North about data. out

ABVD we more docs is a like and a frontline sketchy community, will from in out the and facing uncommon frontline, have few And the and that and more of at some at groundbreaking I bringing there point our docs to no we're when into have something are on we frontline lot their regimen see data all. The all. approval data. used mindset, this and great connected Hodgkin think of And together it just getting XX-year that could because I at with ADCETRIS their you think based ADCETRIS ADCETRIS be we patients into we you're year, doubt, not could data, said that will doctors where feel they're We and E-X a it's help lymphoma to. have to so the convert not bring

don't good about hard to are strong. the getting doing these mindset, we other really ADCETRIS a into very adopters. the these It's is busy, the they work matter had docs think different data just we just up the with and that got work just getting they're get – very frontline to what's And in ADCETRIS, we're in and patients they're docs diseases, a early there, getting and think of out patients. and Our beginning we about treating I out on patients yes, docs and It's out data busy, get and, right hard now feel about It's really think to them, the their they there, morning the their little future. talk the feel bit it's just North – about and American doing there get of now.

Geoff Meacham

E-X characterized, updated view, just setting, to just PTCL. view maybe and academia the this And the community then Okay. you It for rollout, help with differences the us prior between the of seems OS pitch will ECHELON-X context unmet either need, easier like get a the be and to in but obviously the I for back just better way the want setting. same practice

Clay B. Siegall

little lymphoma Hodgkin disease every wait lymphoma than this. realized, lymphoma ugly is maybe that treat doctors is this, to a And it. initially different. having them practice. these is they over has take cells, a for lymphoma, harder start like frontline specific could the Darren some slightly having as really drug diagnose a nothing minute, years, to been bit I a B-cell see some T-cell different. look for diagnosed T-cell lymphoma. Sure. There's this certainly Reed-Sternberg quickly. the could and then and T-cell cause to But Hodgkin a lymphoma But big changes drug close will at doctor cells, PTCL has a has color

can B-cell you is because community going going sometimes I not more hey, in bit of academic just we're see says; what a the And setting, us, to this little it's happen the think us so lymphoma. is, because what tell we're help is sure to

get help they academics. sometimes so from And

I know Hodgkin, bit opposed a unmet really docs, they So that as bigger token, need. there. this on see academic we'll to more medical think, a little same the the But is

more dynamics. So I color? any the have And think helps. Darren, it's you not do identical that hope I

Darren S. Cline

frontline the the in a When gravitation both sales force setting. treatment in execution diagnosis, they typically getting norms. PTCL nail CHP, we're can patient, approval, our see plus messages get we be Geoff, could this confident the this E-X is out when the for And community so got I on think about our have ECHELON-X our Clay upon excited, results, results, they've Yeah. regimen those us the will some you we back we to had head. ultimately academic call have feeling I around historical expanded we comfort, Tougher think for points of mind, on and community and to I physicians, information after physicians. historically docs the there'll opportunity in E-X results mean hit the and E-X do in the the with so diagnose overlap think and a now great diagnosis great ADCETRIS the versus that you treated to

Geoff Meacham

Got you.

Thanks, guys. Okay.

Operator

Thank you.

next Our & comes with Company. question from Hsieh Blair William Andy

Andy Tsan-Yu Hsieh

Thanks my taking question for Hi. me squeezing and in.

So I have one for Darren.

new quarter, in are new break growth, the for dynamics if and you from I wondering are down think so the this growth accounts? return the about that XXX mostly talked generated the seeing customers, Just quarter can terms adding accounts of us. it by about during for you you first

Darren S. Cline

Yeah.

community. over Andy, added, We in continue new we see see time, predominantly now. split the to the And accounts

at you XX% it's If XX% academic. treatment, community, look about

find get out North or specific to again, during as we're about physician we've starting get the as there So to, talked data community make inroads, we American patients. continue the and potential we And to call. out, every

Andy Tsan-Yu Hsieh

a basically follow-up detail because that. number large volumes? doctors lymphoma? I on correct volume, way is they're to just a of the community are across to is And really assuming Hodgkin low in – academic correct think Am Is about there physicians strategy usually that high whereas

Darren S. Cline

diagnosed frontline and all think think IV XX% about the I Well, you diagnosis, Stage III community. if are Stage in of about

typically American oncologists we three data. year. where the the that's in only launched for I per years continue academic focused four other academics which to a unlike And the where ago, years, on need been North reminder, community. again, not seven community relapse the is to in So is but of just most patients we there's them, – see when mean were focus many that center, promote this our And yeah, we've or

continually data. around educate So ready treat. we need they're them be comes when in to then to a to And in, there the patient

Andy Tsan-Yu Hsieh

just Got it. EV. question quick on one And

you trial in Keytruda, looking In population terms EV UC? in PD-LX this planned at of with are the the positive frontline, combination

Clay B. Siegall

So, question. you for all, the very first thank much of EV

get and we The is so we the trials – next comment and positioned to while would I company, on EV. really with both frontline on like Roger, company, trial? us. the exciting mainly tucatinib questions, year. finished I data question you EV mean, ADCETRIS multi-drug for time a an this we're becoming a appreciate being As

Roger D. Dansey

Sure.

So thanks for the question.

all the an on we obviously approach based all-comer landscape by been is We basically been competitor around PD-X, are taking take the stuff will be PD-LX that reported combination selected. data, has that impacted on there biomarker biomarkers, understanding and measurement, a the to So somewhat focus around on for need we in the the rather comers. approach but account that's than PD-X

Andy Tsan-Yu Hsieh

I I can. last If see. Maybe TV All right. on question

think plan I ovarian the is to into cancer. expand

mind level patients? you think me reminding So, a the I XX%. ovarian saw paper I that Clay, expression would cancer among about said

you I and the consensus that's field. for indication that the in one do new a know need if don't foresee you across would TV? paper biomarker testing And So if that's just single

Clay B. Siegall

and on registration the a our and to cervical in registration – to that's one. TV question is appreciate get hope a it. TV I cancer, first trial, in

Andy Tsan-Yu Hsieh

Right

Clay B. Siegall

what further also we and call go basket into so a to up we're correct. going We've opened you cancer, ovarian trial are

I that looking actually a in have a high, in high many a tumors. factor but quite expressed actually solid very, we're think, without is number, few be So it expression. And ovarian, quite tissue little locking might very tissue high. factor specific not is XX%, just on solid density it's tumors

say wouldn't ovarian off at density, may would calling I blunt basket a as XX%. it's – XX one say, of I after person's but a ovarian cancer, doesn't but solid tumors very say into And part in trial of XX%, high high histology it the cancer, It's it. density other cancer few would that is other not you're of cells. say person's may our in kind tool, got excited far as ovarian studying saying also would XX%. years cancer. So so really we're be histology be antibody what looking I about binding quoted And we're as very

Roger D. Dansey

Perhaps biomarker; just is to add old independent approach. comer I it's an may, evaluated one comment if of TV is being any

Andy Tsan-Yu Hsieh

answering cool. you Thank for questions. much very all my Okay,

Operator

you. right. like this call Thank time, Pinkston to turn back I remarks. Peggy closing over At the to would All for

Peggy Pinkston

That's Have you, for operator. a Appreciate us. you evening. joining Thank everything Okay. good today.

Seagen (SGEN) 25 Oct 182018 Q3 Earnings call transcript