SGEN - Earnings call transcript Q1 2019

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Operator

Good day, and welcome to the Seattle Genetics First Quarter 2019 Financial Results. Today's conference is being recorded. At this time, I would like to turn the conference over to Peggy Pinkston, Vice President, Investor Relations. Please go ahead sir ma'am.

Peggy Pinkston

Thank you, operator and good afternoon everyone. all Call. to welcome Quarter Genetics to Conference XXXX like of Seattle you First I'd today Clay Roger me Simpson, Officer. With are Chief Officer; Chief Financial Todd Executive Officer; and Dansey, Medical Siegall, Chief President and today's our in & on Presentations Accompanying are the section website call slides the are which conference available under page. Investor's Events supporting following prepared remarks for our today line And questions. we'll open the as include the including of call will expenses; submission outlook, forward-looking among such future the and conference regulatory future regulatory financial or anticipated XXXX ADCETRIS milestones timing sales and statements and and to Today's readouts, future data events relating and performance revenues, approvals. and financial operating cost company's company to and including XXXX the clinical the achieve those others future regarding anticipated potential company's or developments or materially forward-looking from differ these in may those implied Actual projected statements. results a and may forecasting pharmaceutical uncertainty that development factors sales, the process. and cause associated expenses, revenues in Among includes the regulatory and such the difficulty the approval with difference More the Report information the the included the Exchange Annual faced including factors by XX-K caption Form XX, filed risk the contained in uncertainties Genetics Commission is year Seattle periodic the Securities ended under report company's with and risks for December XXXX. on company's about and

Now Clay. the I'll turn call over to

Clay Siegall

good and Peg afternoon, Thanks, everyone.

the to This drug. from the on the illustrated reported by EV we of next to top becoming urothelial vedotin further company. data cancer XXXX our marketed multi-product in first metastatic we oncology was puts quarter become the During positioned pivotal path Seattle a which Genetics line trial remarkable enfortumab

seen tucatinib ADCETRIS sales grow first are and Canada HERX U.S. lower two in in are and $XXX throughout addition over increased XXXX of compared January the late-stage enrollment of since sales continued net to-date. ADCETRIS's including patterns in to the quarter have that ADCETRIS XXXX quarter were cervical in and range were tisotumab other million month growth cancer. to positive first net quarter the we targeted the metastatic We first sales late-stage and growth. in April in but Ordering month have light our first typically year in strong year. reached of quarter. in the Sales sales to the milestone full XX% December of cancer, in $XXX we are ADCETRIS pivotal guidance trials also $XXX of pipeline the These maintaining by metastatic vedotin over million. million XXXX, breast our a and programs; patient

grow in driven to the two primarily We frontline Canada, our expect continue sales U.S. and ADCETRIS by in approvals will XXXX.

First, Stage This expressing in since indication; pathways. initial these III a guidelines is in treatment restrictive guidelines lymphoma frontline classical and November. more CDXX launch lymphoma than One translated our brings and Hodgkin March, are key approved indications PTCL to recently, of NCCN which Hodgkin XXXX. the IV into number are dynamic six in in more labeled

will pathways patients the approved our guidelines. affairs towards to recent with utilization physicians indication. now compendia ADCETRIS frontline restrictive EX changes ADCETRIS was with there Notably, XA of Hodgkin guidelines a of guidelines NCCN speak more In for recommendation the number to medical includes the and clinical teams neuropathy. of other settings. opportunity lymphoma words This recent use are now to work the the IV and an in NCCN to aligning no for a Stage for commercial and listing Importantly, a known update III update less closely with frontline provides Roger regiments. towards

We physician. role time the have a This that now turn among raising amount many treatment to recent many understand I'll lymphoma allows patients could to ADCETRIS significant information outreach. year. intensifying Hodgkin awareness their we disease PTCL. physicians of per our see researching online to patients approval are believe options. We through options efforts lymphoma patient Upon diagnosis, with most awareness the patient increase Hodgkin a patients notably discuss patients only digital spend know and that as few important our they because is frontline treatment in

consistent in a or American submit Society containing a mechanism. we the received with February. hearing in safety health I'll a triggered the While ADCETRIS a plus and be it's also EMA to we're believe approval both, June. unmet of a early trial developing September may with and we that will data new frontline the trial EX also top the reduction and these This year expect in tumors. PTCL. this relatively the PTCL in from collaboration now a fashion We line new approval an the In advantage the with Astellas. near-term in physician platinum survival There who will regimen vedotin Europe risk the and the These made data CHP late and to enfortumab The an malignancies us. is frontline CHP pathways that in EX We our we be annual standard-of-care Canada, trial also Japan inclusion at in basis frontline it's combined on frontline partner, especially in the reported approvals. still Biologics other the Phase NCCN in rapid significant U.S. frontline multi-product expand activity II plus move this authorities year an company expressing ADCETRIS in forms for lymphoma regimen milestone application need efficacy the EV a Hodgkin the we frontline decision for target to million U.S. and of Hodgkin data recently Clinical positive death. goal approvals progress resulted to the The accelerated to that pivotal patients patients PDL-X launch and EV-XXX which data, Seattle oral the presented submit that meeting submitted as patients. positive to Takeda, solid plans a to EV-XXX Oncology March, Takeda was PTCL. by for in in advantage application and inhibitor. PD-X lymphoma, also in or had In we're reactions plan Genetics a guidelines standard-of-care to treatment in the early overall FDA establish period well we in label. have payments PTCL showed from $XX the by is approval license our outside The pivotal drugs in the In into in as to transformational the approved for with is lead under CDXX demonstrated EX XX% in for community profile hematologic of of ADCETRIS received and are to

In advancing in cancer. programs Both positive trials. of pivotal addition and These in novel both, cervical of tucatinib these cancer, to we're are breast well as followed HERX metastatic including number in agents. ADCs by programs metastatic are as stage a are vedotin EV, tisotumab earlier

companies. treatment is ourselves to this are address the of of by unmet ADCETRIS strongly is other having in progress the positioned important therapy; portfolio in globally needs demonstrated is the conjugates medical cancer with significant lymphoma and Our by EV, role cancer positive increasingly impact playing patients. an Antibody-drug

lymphoma in in An polatuzumab in date late-stage diffuse is application ADC which XXXX. in collaborator the in an large We of for B-cell a filed myeloma Genentech/Roche a was a also in ADCs. from and relapsed include field in multiple advancing developments. priority several XXXX. has clinical for U.S. has August also Europe. It's is XXXX. These have regulatory time for in III of and the PDUFA ADCs second review GSK ADC approval vedotin received exciting trials And several glioblastoma trial in AbbVie data half an ongoing expected planning submission with in the Phase

development the comments Now then activities. will discuss will I'll who results. call over turn first our financial quarter on Todd? our additional Todd Roger provide to And clinical

Todd Simpson

the portion million, ADCETRIS for joining our call included revenues Great. Thanks, and the to ADCETRIS and afternoon. royalty and the quarter for $XXX were summarize Takeda's a this I'll Hodgkin year. results guidance of the milestone quarter by with quarter the $XX this of to first financial on in were Today updates and quarter few primarily of XXXX, additional lymphoma. a thanks obligations Clay in XXXX XXXX. for of earned million to in our amounts the first Europe provide of Collaboration XXXX Total royalty us the expansions everyone million revenues increased lymphoma and ADC net collaboration quarter revenues of over our XXXX, meaningfully were revenues royalty first frontline the in third-party in sales expired revenues XXXX sales increase XXXX was of the despite of U.S. under Takeda first our amounts XX% sales by XXXX first quarter ADCETRIS Canada of payment from This related of in million. of earned first in $XX increase over the Takeda royalty attributable however, comparable first PTCL. Takeda quarter This cost the includes and deals. Hodgkin the which some X-label the included portion Therefore and decreased. Takeda, in frontline approval $XXX a driven in reflects

compared of in XXXX first of indications, investments; in the notably increased to and to ended were Turning common in in SG&A to in $XX XXXX; in expenses XXXX. end pipeline to this the late-stage as million in $XXX the of quarter now holdings to the the the pipeline, frontline XXXX cash reflects our support tucatinib million programs. Expenses expenses costs the stock efforts to ADCETRIS across the compared this quarter at and as EV, first $XX approximately $XXX primarily programs; investment XXXX our in Immunomedics of R&D quarter. first quarter $XXX million million quarter $XXX late-stage expenses. first in well million new increase million related We first with of our quarter TV. commercial is reflect addition in to

gain mark-to-market these the resulted in reminder, of for non-cash a $XX As first a shares million investment and quarter. are that

last trials I including progress outcome. guidance; Regarding financial our XXXX late-stage mentioned provide pivotal expect our an that to based programs on quarter with updates we

increasing expenses that We results our SG&A based $XXX preparation well million. of for year be to increases those EV-XXX activities million in These $XXX $XXX XXXX expenses. to of the trials $XXX late-stage assets. our was activities as clinical One the in of to expect expenses and we development R&D launch of now be and the the as expectations range on positive the million for for million, EV, range reflect are will

unchanged. Our other guidance remains

the over Now to call Roger. I'll turn

Roger Dansey

and everyone. afternoon, Todd good Thanks,

the urothelial PD-LX safety rate EV-XXX inhibitor, with a regulatory was As decreased PD-X neuropathy. the from Amongst the most platinum From are XX%, recently regiment indicated our common our clinical appetite, a reported and year. this with priority support related perspective rash trial. a from plans or this is the fatigue, a our that and the consistent important teams included events patients submission submit was previously working BLA results and both and treated response the together response metastatic BLA development duration [ph], Astellas treatment who'd alopteisa objective rapidly Clay Phase receive trial exciting in to achieve partners I patients adverse and confirmed to cancer of peripheral objective. The

We continue cancer. work plans to active the urothelial for development clinical this expanding on highly ADC in

the This a trial of to population cancer is and enrolling second but who'd with platinum. are of PD-LX metastatic still patients are We or unmet PD-X urothelial a platinum received EV-XXX the naive need. treatment, also a high cohort ineligible

the confirmatory same well-underway. population addition, the in as and EV-XXX the trial is is EV-XXX enrolling cohort one In

including Pembrolizumab trial, EV-XXX solid Seattle setting. and/or to line tumors. are opened that we the in conducting combines EV-XXX have which EV for also with topline considering platinum also chemotherapy data in positive are for first metastatic other in door EV the opportunities we The other development, the further Importantly,

Next, I ADCETRIS. will turn to

showed E-X medical data We follow-up, educated updated ensuring the plus neuropathy extended in AVD the was benefit that on continue at the continue that work ASH to This for on XXXX. data peripheral and resolve. ADCETRIS presented study, PSF the to maintained including the with community is

an to we E-X exposure status. injury status the We in contain escalate regimen potential by not for approach in bleomycin important AVD from to the not this are using pet the needed is clinical reduce response. communicating was either modified did the for ADCETRIS information due to adapted is of [ph] and lack lung as also pet intensity frequently [ph] ABVD chemotherapy cycle or bleomycin oncologists. of if interim The E-X plus think by outcomes of to practice

combination regimens well-tolerated options second the is The and in better outpatient-based cross-trial than, E-X or therapy. of availability in have guidelines, Hodgkin with the salvage regimens data for similar While important be provide trial. their pet-adapted now the as from Related the to as are bendamustine comparisons specific with [indiscernible] they to line Opdivo limitations, for listed NCC for population patient and ADCETRIS effective these appear example, combined setting. lymphoma patients

the Another update now listed is Stage Stage is of this the is to over is either all unfavorable treatment and lymphoma, outcomes. ADCETRIS frontline as Hodgkin of age with disease with the with for III where in for also a [indiscernible] and that combined guidelines I II option traditionally patients and patients. an as associated a or it recognizes value frail treat population poor addition in to ADCETRIS believe important IV XX We the difficult

B-cell ADCETRIS number Another new lymphoma. to combination potential development as of this is regimen, area in in the lymphoma has highly of opportunities. been part shown settings Hodgkin the of large for our focus and for active a be diffuse ADCETRIS various

the We'll label expansion result you as now tyrosene we've posted reached. move inhibitor support enrolled in target targets Tucatinib oral datasets. two we of primary evaluating these for called tucatinib patients ADCETRIS HERX. including cancer program brain tisotumab plans pivotal vedotin. now informing announced designs Today this patients in is on our and/or We the will is HERX+ programs, that enrollment an trial metastatic with The randomized breast PFS focus stage are of practice mature. We kinase XXX pivotal HERXCLIMB that earlier to primary HERXCLIMB, I'll patients could year been and endpoint. keep support several XXX the this announced that in metastases. HERXCLIMB has which analysis of trial

how data strengthens help ADC believe increased the that HERXCLIMB patients advanced in overall which study the entire be and analysis in a are rapidly PFS key to tucatinib trial we brain with this to be of in with important additional or in Ki. in climb are size TV looking in developing class the vedotin are has assessing reporting the reminder, We patients year. has Genmab. need. forward tucatinib endpoints will a secondary As we These survival may the metastases. and Tisotumab later HERX potential best and partnership to to endpoints is

The was outcomes with earlier enrolling of TV and in inform cancer. Gynecologic conducting women evaluating and with into under a completed has TV for agents a combination We are which strategy cervical submission to other our with cervical single-arm also X were of remain median Phase to safety mechanism. with six a approval designed the reported. or previously where no review are months. We metastatic FDA's of from profile by by confirmed standard endpoint we setting of of Phase care in recently are a Society this review. is the independent moving the TV objective rate TV Updated Oncology are recently the in The trials confirmed showing trial is there cancer as pivotal response X XX% duration of at is rate objective Further, and enrollment data trial tumors. lines recurrent reported of other data support We by response the Genmab primary encouraged single-agent independent poor. trial accelerated of solid of response annual patients regular meeting

we Beyond including therapies our late triple-negative includes with stage vedotin, is advancing in in cancer. are other multiple ladiratuzumab for several portfolio, cancer, Pembrolizumab. This trials which the breast for combination targeted

XXXX agents. to submit we expect addition, more during XXXX other and several INDs In

this ADC SGNCDXXXA data including we activity data for month, and earlier on AACR For antitumor models at The novel cancer. in non-small showed or on several lung stem-based example, cell presented tumors. melanoma preclinical solid

trial over call initiate that, the Clay. to IND first With this back after XXXX of to in turn I'll X expect agent We the approval. Phase

Clay Siegall

Roger. Thanks,

portfolio. across activities the open line the recap we I'll our questions, for key Before upcoming

continue Hodgkin's ADCETRIS the in First, stairs lymphoma frontline care of and frontline as PTCL. establishing

year. results pivotal Second, a and to from trial on report June deal at pull in EV this BLA Europe cancer submit in ASCO FDA

report this Third, for Operator, fully is pivotal trial enrolled. and the lastly, HERXCLIMB in pivotal of And At open now the line Q&A. from trial please the topline which data the questions. TV we'll open XXXX. for advance cancer, cervical call point, tucatinib

Operator

first [Operator Michael from question will Schmidt And with Guggenheim. Instructions] our come

Michael Schmidt

comment could quarter dynamics understand figure a relative wiring patterns. terms little of little of the maybe the Clay, for bit those contribution in sales the growth you organic and help just through on a more the to taking dynamics you quarter, ADCETRIS us first Can thanks and my in Hey, bit better? questions. fourth to

Clay Siegall

can Well, sure, I comment on this.

Let ADCETRIS me is doctors that start on. really saying that a drug depend by remarkable patients and

seen well. But quarter softness is first in this really sales we've much the there oncology sales of in a as can and First in products year. and typical pretty February and April. every higher in and say we've January, in what were see the a strong all, lower And is it I March you higher other in had

So, I where look going it's think when month-to-month-to really month, through feeling about time. good we're you at

please Second is coming up standards is many that ADCETRIS care mentioned years. as around note we've line, of been against for all, of times that XX have that entrenched in front

take maybe very thing will and So ask, important mention, think you the forward. And NCCN time. I'll it also third didn't going the discussed be that changes these we does we recent

Michael Schmidt

Okay. mentioned Thanks is now that. on for you -- question the then fully enrolled. HERXCLIMB, clarifying And a you could study

you Would success out, question data later and potentially set a assuming PFS bears the filing potential then wait obviously? on OS data to for have to submitting filing timelines endpoints secondary anticipate set the the here. potentially Just initial you on including potentially read for on or analysis full would filing,

Clay Siegall

how about you're we I we're point, doing, that all caveat confidential give what HERXCLIMB thinking we're turn really I'll we a what Roger over really, to some can't good what with mean, on of of bit are answer Michael. it to you but talk These at this of is internally. to that saying the questions asked color little about you

Roger Dansey

Clay. Thanks, Sure.

is I and the primary PFS out, endpoint general, endpoint circumstance, So, two with in patients the trial a and secondary in key focus metastases as the is clinical pointed of entire you we on survival. key the brain PFS have endpoints, trial. mean, population overall primary the in

a is like primary are plans that readouts positive, finding so, would the if one trial And focused endpoint. would on -- and look make around primarily is that what a approach

to obviously well. secondary are have important Although, the very endpoints as

general any what help. of sort doing, giving some of hopefully it's without that specifics So, we are around guidance,

Operator

question comes with Our Markets. next Kennen RBC from MacKay Capital

Kennen MacKay

guess guidance the ADCETRIS I of respectively. something you. color what's somewhere going of can QX, within place? the was going understand if guess And in some sort of is in conceptualize QX and happening help another wondering how of beyond Obviously, and low for growth there like as benefit change I taking really for the front refractory was quarter-over-quarter much to helpful. or that seemed going X% on high we're any quarter-over-quarter sort to I is then what end the standard of taking us sort it be came of XXXX And rest on potential I just sort of to the relapse and the from throughout super to It when years, you last Is understand they're one thinking sequence guess clinicians thanks need price come you was hard next the Thank ADCETRIS. the Hi, mid-year saw to couple timing guideline would seems NCC but in there commercially guidance, care, me like checkpoints that we from? reach that changes guidance, the throughout for question. quarter. is especially setting help looking XX% the year. could of the QX to the at to from with And growth, of this where impact, order was of to us about going just it's XX% Hodgkin

Clay Siegall

of as bunch I'll It's them Sure. here. try a heard them. I to questions take

important match excuse a lot has the after our So, it which of and of guidance, mean, a in holiday. drugs, feel does and and some change cancer matches, right lot seasonality history as far me, sales they as to we this that the sales look, been -- quarter-over-quarter the month-over-month, other have very I

one a I get we we We E-X an guidance. mean, out So, hit well. I guidance is, into provided growth that provide tracking we not is in well, too wouldn't can the that did wrapped launch quarter we we it. that. it feel is that lot of quarterly but hear going from The feel we're docs annual up and only

So it's early.

coming E-X is data out data on watching and more ASCO age have strong. We the of

for guidelines, And were good. guidelines that so, literally ago that doctors all of But previous a and some the closely But has has never to there that for that much what few of can couple But now E-X. the of really weeks more changes label, something more it we weeks really feel is it's the of prescriptions write made doctors than the for ago. pathways is case because which label. NCC closer match to going and restrictive committee now But the open some were is label. as matches the E-X had the limitations is a initially

talking think we out get there doctors talking pathways. to important to something to that's that's that very and So,

thing So, new what we're work to it complete the helping of as and that's But using really their see us with doctors the and happiness growth with product we a in patients. excited on. for

to about back then mentioned, me the as price could Todd, to I'll benefited, the specifics bit the turn turn talk Todd As that over it last little talk you price specifics. question. to a And to far about you some

Todd Simpson

Kennen, Clay. Thanks, good question. Great.

We is is under a ADCETRIS that of quarter, So, price increase limited do color color rate PHS point. did was predominantly increase. little to volume-based. maybe substantial a but price growth we part may a have bit business covered a can increase, want it look little pricing. more when the the at And did sound while I on When to that price January, bit PHS the give you unusual, the I give inflation. little A more around is a of in bit all price in

QX to saw into the What a in the ordering of So, in shift business. little it very relates PHS we see actually through as a was PHS the of increase in mix a business, price bit we come quarter. sales little of of bit part more net little the

increase, did vast see of volume-based. most majority we was while increase of and, a the increase in the in how And all sales we form with well the driver. didn't of a we're again, through think price So, that quarter of for the lot the a doing the drug. we And come bodes for that fact, have

Clay Siegall

patient of a plus of a plus Really and fuzzy. rate a with rate bendamustine And an Thanks, a checkpoints, XX%. I you bendamustine you Hodgkin Todd. And ADCETRIS the new about is time in relapsed now fact, important, you, And going guidelines and Nivolumab, tolerated have rate a CR overall bendamustine. in guidelines really than of ADCETRIS which question's few better in data. overall guidelines. ADCETRIS [ph] little was any and chemotherapy, XX% conglomeration has previously only let setting the tell of CHP it plus relapsed newest your out regimen. just ago, this And, of response ADCETRIS the me lymphoma an XX% -- CR was and weeks guidelines, to for a a it it about the response specifically first weeks in ADCETRIS And refractory but few which what plus plus remind of truly listed are a can rate called ago, is also has states, XX% question, amazing in

a at use with for and rate to agent use response it's to take in highest concept have sequence whole you there to XX%, that single do you it And be, at work the choices So, of, get? guidelines. it's of highest well takes the just now, and not recently, sense them the kind makes you in and does rate it the doctors how ORRs get why two CR look And a certainly can you that.

for something refractory relapsed that's patient consider. to that's really so, And important the

Kennen MacKay

here is wondering filing gating I'm [ph]. at more that you point little to line expect the the Super so EV And have you. we for One just what and wondering might understand us I'm helpful. forward bit cancer, Thank Thanks ultra-quick when we could precision on what fine data looking a on just bladder filing in factor a here? help follow-up. much. if might

Clay Siegall

working doctors EV really lot. And important are that will a hard of on the very all the special contact want drug us want it's help deal. something. a for really They us. is a with is involved patients. is I This to We The can tell you this to drug. drug -- EV. real number doctors and be

label. so, hard on is second EV-XXX this working first we're or not And it's that submitted. get so a submitted will the It really time be to third

and So, that to ADCETRIS. in have in all a when different third way or of the label or CMC or you whatever needs the manufacturing be included we've this had fourth that's one a fifth with

doing and have the on very confident with So, we're plan EV this it. at together, one takes hard really time, big going that's same on. a little longer to put a development what but with we very working are We're

saying So, this we're year is -- what submitting. we're

Operator

question next Morgan. JP comes Our Cory with from Kasimov

Cory Kasimov

on this Thanks for for guys, Cory. questions. is Matthew Hey, my taking

reaching curious QX. prescribing out what I'm over of to on physicians you're versus how ADCETRIS, on would First, seeing that physicians in terms more you characterize

Clay Siegall

fuzzy. You're it time? asking The know it ADCETRIS You about a I Can question. what, was little one you didn't more prescribing state hear -- that.

Cory Kasimov

Yes.

Just versus QX. you characterize wondering depth how would in physicians reaching more prescribing physician

Clay Siegall

the have Okay. patients the we and docs refer keep so there kind a prescribing in front stage we late docs years, on out every not It's of here, you come line. we're for treat ADCETRIS. seeing some so more it's prescribe more out yet been few I and though even more seeing will had say docs that that hematologist in

about that's every really to QX ADCETRIS it's growing. to using seen see And data of have doctors great continue and So, out. in since quarter depth we've the we're that seen the come something excited in

Cory Kasimov

calling positive pretty have that the on And full docs data, what ASCO? data presentation quickly but it. line looking top have they been been on mentioned the you you Got just EV, and see at then to are

Clay Siegall

thank question. the you I Well, for

their for present of that of reserve have to it to was we also at principal to important investigators lot a them the EV data data for conference So, data. for have worked lot the a ASCO. And on

amount the think look includes will is top safety CR parameters there And of data. data other the and and and line substantial rates XX% that released. a I things in of can So, be at, that of see you data out all that that you'll while is is there plots that efficacies and other substantial waterfall sorts the data there,

with us. for also ASCO put encourage I out in an So, section And forward presentation you get we you really thrilled looking peer oral And the of data listen. journal. publication to sure a in the big to the where review would appropriate got these really making we We're diseases.

So, on I'm EV-XXX. And later very the forward And what's this year going look we may you'll to hear out putting with combination that's keen on data inhibitors. add of with and just checkpoint very with EV really that about of that. more pleased also something I we're

Operator

you. Thank

comes from Meacham Our Barclays. Geoff with next question

Geoffrey Meacham

won't little versus Thanks a where Can with month-over-month you the question. a Hodgkin's, of you seeing help lot. there you impact respect effects the you about to good sequential trends. got growth? could on any year. external for I the follow-up And think what's ADCETRIS Thanks talk for couple. just mentioned are, trajectory bit a beyond taking And PTCL happening. the Clay, guidelines, balance just growth other are I've that

Clay Siegall

we we break not see internally, that's it understand really don't But and what areas to continue PTCL, asking. that you're Hodgkin's that report. will from expect growth both if that's I at we something in we growth do So, look continue but there. out the

have guidelines to to is label recently. to something guidelines the quite it's very think We the And is of this aspiring with the closely work more label. We're I a more thing that we matching think information pleased guidelines mimic lot certainly for data certainly to docs right We And get have committees to that. and just thing guidelines and that provided important toward. us. been happened closely there. right the for be the the the patients

at they're meet you to year? a the that is good going think really we rest for more year the the for provide And and question, of committee kinds that data. so, whether expect do them data we speculate The once to meets committee can't as, far ask as asked a of should we them anything and these things, later The will with they this year. And more. provide us committees I sometimes

that gets to when that And time you the aging out continue we time you think and benefit over saw period. last look as ASH, looked curves I only Kaplan-Meier at longer the and we to longer it and longer. even E-X better data some at I get of the present presented data the is the

because a think know, And E-X, not as as have had but E-X, is so, improving. with OS you factor data maturing important it's we reached with And I here OS our that's really yet. we

patients. and get chemotherapy. substantial important in our in them more as doctors And pretty a disease and the the matures, to So, time doctors how really to that have a Hodgkin data of because them curable a lymphoma use containing look this, and longer ADCETRIS gives at is I've seeing their this are for quantity patients more for a lot say of it heard comfort will is Kaplan-Meiers regimen improving potentially

we So, data. presenting feel we're that, on that the and we that and working see

Geoffrey Meacham

graphs. and helpful. outside just get you're Thanks. but [indiscernible] in updated progress clearly, to making breast I with then your That's view enrollment, of And cancer want

it originally were where that. I colon think but other wasn't and some tumors, perhaps I Cascadian HERX had or data with you sure

Clay Siegall

on want Indeed, we that? do. to Roger, touch do you

Roger Dansey

Clay. Sure, Thanks.

obviously whole relevance. tisotumab vedotin role the overexpressed HERX of is diseases signaling pathway The correct. exploring gastric tucatinib diseases. and HERX is interested Where You're and very CRC cancer and like in including of we're

investigator-initiated about trial be And may think looking ongoing data cancer we're possibility plan to in we what disease. do. There's will able tucatinib else looking potentially in thinking understand have be later the CRC. important sometime we gastric carefully year, which at that order and like to So, development what is this that available there could look at may a

even that, mutants. whole of HERX Beyond question the is

to So lot opportunities of a further. there are tucatinib us explore for

Operator

you. Thank

Sachs. from Our Salveen next question comes with Richter Goldman

Salveen Richter

the build that Great. sales I you blood traditionally Thanks. can up tumors and been Meier taking follow-up. EV then on how some launch, as for force cancers move when color you're have you to envisioning first that additional from a regards provide to indications think progress it's solid our in on This you Thanks questions. Andrea is for for you as with Salveen. Maybe

Clay Siegall

very Thank you question. for much the

to important drug and us. us EV, So, the a before, very is it's just mentioned And as I for strong. data

it's or when -- for at anything patients that I are data really objective used above have look It's have other is it's mean, better relapsed seen, you XX% so, what been remarkable. drugs And way that The patients. refractory response else. rate

the data really So, in relapse it's in area. setting that unprecedented

EV. we sales full the force force are So, for on based going that, building on

Astellas have ready person. to all boots are top is time commercial that's salesforce closely Todd, this into reports going commercial all around just happening aspects And XX/XX the going globe lead ground like you bring wondering, something? that a Astellas. of that We and collaboration in were well. And by to to I'll working would we're on charge launch salesforce like and we've now. of you everyone, this with in our them person have in the will that be and that build remind the this is very product, people remind buildup ADCETRIS, add is the cranking forward. We're a really we'll on to we so and of you, with the we case And grow this to done with fantastic a we're drug with as

Todd Simpson

leave to BLA and team a once get we I it is of we're see what envision infrastructure we team kind the thing. leadership, for timing, ADCETRIS to thinking might with ADCETRIS salesforce. the respect in should activities [ph] be for a to expect update build maybe that the real EV. as we're we But give guidance you preparatory pending was some can do that on the look then underway. a with right. in think things more of just more large separate We bit doing more and boots now, the commercial be that the timeline. being commercialization Yes, mentioned we'll separate a Clay distribution we've ground become clear a to a how active look type that to We of completely insights some and And submission as respect pieces like, to way would and there about about what date think ADCETRIS on at there, into but salesforce, the of to devoted like the color degree little I what sales the thinking sales on team. a then solely We're leveraged submission start the want some paducah like the built build leadership it just timeline broader far as have looks

Salveen Richter

then about agents a of number Thanks. just Great. positive And target other also just shown having the there opportunity help can on tucatinib, benefits? competitive you HERX one think context us the of in that

Roger Dansey

It's Roger Sure. Yes, thanks for question. here. the

tucatinib you're is best I it's we obviously in bear taken TKIs, inhibitor TKI. referring to, So, do we orally. [ph], think TKI small mind, and competitors molecule oral HERX class a in neuratinib/lepatinib are the an have The think that other

essentially Trastuzumab. at we is So, depending see some data such on a form Other be very as we molecules clearly. argument will how to HERXCLIMB players ASCO make [ph] may off, able that modutaxinib of better

rather we from approach direct so, competitor. than of it a would And perspective, more as direct a a potential combination see sort competitive

Operator

Thank you.

from Andrew Our next comes SVB. with Berens question

Andrew Berens

guys. Appreciate Thanks, it.

to this ADCETRIS the relative on with was didn't at really on guidelines, the and in issues guidelines question ones, previous the the benefit. And recognize certain regimens including the regimen is and AAVD of another look thought useful I preferred has a I'm substitution at the I line when previous the circumstances. an had revision the ABVD the efficacy revised guidelines regimen backup front one and Just still with that other looking

at guys don't to ECHELON-X. as in are still better to just to get see efficacy you going get I saw the sense doctors So, this that potential mimic what

this can have the the to or just message you regimen. I the to how have drug preferred don't doctors at just it lung as in is and the patients [indiscernible] disease wondering get was not use So, that get seen

Clay Siegall

do Roger, that? on comment you want to

Roger Dansey

Sure.

So, such order place the what category definition conditions it pretty the the in though prior in XA. has considered it's to version clear was the in changed patients appeared that you the be in description represent to that of multiple wording had wording a and XA. have And was earlier a as

than had four or now clearer. wording or select for plus contrary greater or four patients in bleomycin than that example, much So, to It IPS states bleomycin category contrary no have XA IPS The non-neuropathy greater non-neuropathy indicator. is indicated.

course, lymphoma definition with diagnosis an untreated non-neuropathy there's in is of at Hodgkin and really XA to just patients generally clearly younger wording unlikely or the more category the into are of So, And, neuropathy. have state no group. people

category agreement it's a recommendation. subtlety a difference XA. guidelines in is between So, Nevertheless, around difference obviously important unanimous the the and it very around the to indicating XB regard

Clay Siegall

lymphoma not a And And add I look certain certain lot reasons. of patients at you lot that of a of will with under there's you're groups a use pathways. that variety then for to pathways, Hodgkin when discourage a XA prescribe if pathways

when not XA. And hesitant majority so, up patients opens it to this are use now for XA. is a the And doctors of it vast

difference big old. a is And from weeks so, we've it's two what had. And within this

and we the that to with to has now log a jam and get various just we're potential so, impact there pathways had it there out And really the groups.

Andrew Berens

get mean sports at I it's to I to benefit it AVD? preferred then tree. definitely take if there's other wasn't improvement, the compared could not substitute you is and three benefit then of options, efficacy because for this, I chemotherapy. the it an full to treatment two for it to is an one [indiscernible] AVB restage look regimen two are the branches the going I the Well, that recognizing but you reflect and these the and And other which actually wonder to when the Right. branches, that what's just preferred the cycles ABVD, wonder cycles reasons if include or just guidelines

Clay Siegall

guidelines. guidelines for you patients. -- higher very And in a efficacy. the and change. bleomycin a asking no about you this longer, regimen There remain get toxicity get and time, and don't we And a get have our even track better excited that you efficacy. really better ADCETRIS longer And as saw doubt change over can is good We questions AVD is just some You're we data. you

AVD the ADCETRIS put that that regiments talking What the is best making these entrenched trials lot is doctors us together. are it regimen. rules doctors about XX-year to same doubt who no there's did and a of we're the So, by these people

the started something cure higher when without Hodgkins to against were that bleomycin, of folks who going rate is we depths carried patients associated effects. frontline A the is lot carried it toxicity said, patients and where some and "Why get there said and suffer so, we're lymphoma Which And are lot not true. this with everybody?" Hodgkin up a a you improve it's side in not are of There doing lymphoma in.

there, and we get to Some AVD. from docs ADCETRIS convinced effects docs more the out side use are more the patients the die

really are we progress. entrenched along working this pathway good and making So,

Andrew Berens

of Is force the Okay. results? there docs what any expand sales reach detailed the plans to and percentage to the docs been [indiscernible] have more community

Clay Siegall

expanded you the got our actually in went frontline approvals. force we We Thank and question. sales when for

we size. our So, that think the detailing enhanced force We the we and docs that sales We as force. force added another XX% as the sales academic to right with community sales possible. now, much our the are feel is docs

It's roadblocks as know, get to just to with get out their of there's get a not things. been it a days. used their detailing time, easy as attention. their of office, in docs lot to We've you lot As be doing these different

pretty patients. data effective with dinners ADCETRIS done key see improved about opinion they're lymphoma docs and they are of to the that's talk the leaders talk about talks opinion One coming we helping the Hodgkin regimen, data leaders here, what things hosting when with because key give is of ordering about regional containing benefits and the

change these we about the So, into of used a XXXX tough beyond way But we rules to out compliant make ways get compliance docs with we're the can time need it in to. talk to we doing they because in doing that appropriate talking continue getting are really and and the that. and it to to all do best the through field

is want our big We approach. going We're come what's and patients the been going Internet. on. know whole go the lymphoma hard we've which because digital and a have is especially focus of great working on to things a people, they really chunk to Hodgkin increasing And on. in digital these right that young They lot the thing other of

the patients so, focus their see talk docs placements They people that patient banner And about are we're advertisement activity have at from discussion this. to and media when looks and the get takes the and that. informed And docs, at to a with and data. And when social on And hear like look that our go data. data they media to and to go those increasing ads people, we online patients the they like some of data. like they the the newest on

of a is something really this that focus adding we're lot to. So,

Operator

Thank you.

next with Our of Bank question from Tazeen comes Ahmad America.

Tazeen Ahmad

questions. Hi, my good afternoon. taking for for Clay, Thanks a couple you.

drivers follow-up provide wondering the comments most about then You some collaborations in I more indications the partners, little GSK, give overtime which impact of said and was at know that example, the about what have could you the And on to could your bit on on of then by to a them the could potentially us beginning you what of payments for year might and data impacted for call of the with sense, follow-up you on Todd about your based being the terms [indiscernible] that seasonality color of if have studied financial? I including a upcoming of seasonality. be. was beginning the a

Clay Siegall

you diseases is seasonality some not we see or disease lymphoma Hodgkin you're necessarily pretty if to the much delay So, feeling treatment well super every know holiday. you're lymphoma, events Hodgkin of go sweats with you And diagnosed you Hodgkin decide to may you have like year. and your or are. and if lymphoma don't night after until not just the fast-moving doc, a fever happening

your even start in So, first sometime you in perhaps first coming January for dose.

you more family. some slow-moving So, just that the where hop your could see And you got it a way rapid spend on that than tumor holidays the can something it's minute. you at in more of to your treatment ones and could delay with

something to see do the seasonality. So, over we from and year It's we see year. over and over

better not being than April So, and February February than surprising March better strong. January us see be it very to to was and

collaborations, happy planning year. including second fantastic through is what And doing to frontline. half impact So, in also what in drug we now. trials, the other brought GSK GSK. in a of right market. data potential Onto we're the antibody you them conjugate. are the with is they're multiple delighted some many we're hear this And we're And large That submit myeloma. has up with BCMA they myeloma from the really seeing multiple

to a be patients And drug big GSK really and potentially could Seattle so, beneficial really to for and genetics. that

collaborator get their Roche or likely, included and that pointed two in this is was line the me, PDUFA with And data remarks approved trials. I is have front impressive out fantastic other And August, that polatuzomab drugs likely our with to The very we data. non-Hodgkin Genentech to prepared they also they're date is lymphoma. Their year. that doing

So, but are both GSK then Genentech approvals frontline first relapse the looking and toward trials. ongoing with getting moving there setting, in into

it's glioblastoma and to drug they exciting So, their can this their their what AbbVie, just conference and for level drug, put this two excitement conjugates on waving. about morning have a with see very drug glioblastoma these And they do out numbers call patients. talked it. hand not a It's lastly with

when their trial. from that's the So III you Phase on AbbVie that releases for something should lookout keep definitely data

Tazeen Ahmad

into what the what in regards earlier on expirations? your runway can R&D cash R&D a expenses us the just give your of you your us sense proportion expect spend for with is changes then, heading then talk to you rest a about And based trials sense is year can And late-stage for directionally on the Todd, are of pipeline to you to today? going be versus of you give the that where

Todd Simpson

Sure.

to advanced the with I nicely would have quite think probably late-stage So in drugs respect early, versus you expect late studies. multiple with programs pivotal

saw now been announced very then XXX program RV EV without the gets cranking recently and and assure spent will continue will year, been up throughout be area specific is and TV pivotal study as getting are study, a program, just to that allocation of the investment fairly can cranking we the think the with from spent drugs the I be enrolled. the share by tucatinib continues results rest you what along ADCETRIS we that TV, of programs. positive well. a has big of actually into So in lion like for fully us, significant has late-stage

very before, we're think in talked pipeline in continue I technology to there also as late-stage that pipeline but is deep a we've look focused about So assets we of other the at.

the from don't keep we trying really only a only the through strong in in cash pipeline that position. through but So, receive continues not invest U.S. sales And strong we Takeda. royalties of then be in we're Canada base company the is us a late-stage, ADCETRIS to as to with business runway; well. the respect to our for full and

the million balance sheet, doesn't So that so provide in the that engine million. a obviously on continues have to of million a another Immunomedics to is cash with to about about strong the have ended $XXX fuel We $XXX include position. and $XXX investment for the really lot speak, we quarter we which

to where So added forward. with about we we're continue even our positioned all aggressively really programs pushing feel of that burn good feel well and the really we are

Operator

question Stifel. next Our from Steven comes Wiley with

Steven Wiley

there, in utilization a specifically have follow-up. terms of you beyond wondering initial is I respect characterize ALCL? of maybe to the I know it's you're subtypes early PTCL could some of with then those of which in if seeing commercial dynamics And some kind

Clay Siegall

the say we're the of it cycles want I hearing on all patient said good a that this, for really is we've that's not are EX are a hear question. that was certain based regiment gets use thanks about Yes, just we're regiment, in than just and cycle. do in areas. using that are docs less EX the things EX in that subtypes, to to and We the regiment there how always what they number hearing. ADCETRIS our the they protocol not previously less different not of for little the treated and

drug with EX that it of patient standard about certainly for but for that's so is patient so financial something less a -- -- something EX; or percent size. So it payment it's their on for less, than like depends the XX is less the

just equivalent. something they out And exactly you another to have that question? is that So are not point

Steven Wiley

we'll are Thanks. just retreatment overtime cells Hodgkin's appears wondering of think out I this how is generating relapse be Yes. ALCL? a but play concept fairly with you the PTCL? you within know that if you're And ADCETRIS phenomenon in well-accepted in thinking see to about guess the realm refractory I legacy

Clay Siegall

re-response I Re-treatment rate that on have with we ADCETRIS was works that docs really mean, had showed Hodgkin data well. And early treatment that lymphoma. using data in I re-treatment. hear they ADCETRIS we and in from comfortable XX%

they the One after provided things that regulators, a that of we only be data happened got used in the was of ADCETRIS cap. we patient to could years But first we was many had as that cap XXXX. few how when cycles and a a in removed when more approval, of when

and now for So not with it's use, I ADCETRIS, Much can come on that so another the year then one ADCETRIS they fit. coming the think the they be use of sees can valuable Capital-XXX see with patients. how of they like and or another regiment, cap and that very that use regiment, potential removed treat XXXX, you was they XXXX as with you rituxin, as doctor rituxin we've shown use

the I had forget good question. you very of your another part feel about So second retreatment. And

Steven Wiley

was it. No, that

Operator

Thank you.

from Our next Xu Berenberg comes with Markets. question Shanshan Capital

Shanshan Xu

talked any the XX this which data a and ongoing become quite And analysis to survival tailwind . is just effort another published it. PFS another about tolerate the which from for medical there wondering is on in official given there butter in ADCETRIS? This in the actually in you adult subgroup I'm patients analysis from younger reduction American bit risk and lesson curious think a And have a community I benefits of impressive past. young the was is a promote subgroup you that financial in should if probably North will I'm traditional that XX% the could very for patients you the is ash. that data.

Clay Siegall

American really we EX region you EX for North look at So our folks it. young look and at with we are every which seeing every ABVD at every outperforms we regiment looking proves definitely time over excited looking the We data and area first thank with our every of the all, over way data. the time

but showing And so the promote in necessarily is data you can to. populations not something

doctors the and trying them in ADCETRIS see good out and really it's can the great journals. us publications frontline And for put to get of what power So we're containing regiments.

Shanshan Xu

to I that briefly is forming Another would like upon touch EV-XXX.

with So this see is a you time the combination in trial . or first

we toxicity is squeezing So the chemotherapy me in. given for essentially the And GPS about how combination should tolerability for the actually with think thanks that profile together obviously navigation EV with with the and EV? of chemotherapy with

Clay Siegall

different of So when think you there. in all about EV-XXX first groups of has it a couple

patients. the And is First those one our and groups certain that focused think of of and the we the we EV-XXX in decent year. plus as all most. where of we we've data And in have or later important on probably subgroup lot subgroup EV will most the chance been a the amount been collecting of a that's present is it's this that's called. data its

So most a put regiment checkpoint plus safeties at look an reason contemplated and stay we look platinum the for a the putting doesn't look that plus what in largely we triplet. EV-XXX something is same EV wanted together also arguably those really to important the is because in or the plus And with EV-XXX pembrolizumab. also tuned is the we there together. at two And a platinum. group EV that's to of also In the trial EV arm that's that

platinum frontline is that in trials in the EV-XXX. with that that's So companies doing a And few are in now there contemplated combining also because regiments. checkpoints quite

wanted we be for which exposed submitting both ever checkpoint. so is this are to to our platinum a to have patients goes prepared in approval way that we a doing for EV-XXX be And first what and been

what forward parameters to frontline. really then But important And our so the we And the is comment. a in jazzed towards frontline frontline choice the go components components the all for the best we I'm can future. initially. really all make it But has up bring options and know about that's as in Roger

Roger Dansey

component at trend were the combined ADCETRIS believe in when of EV in mind you combining Sure. a early containing example EX they the bear just for example every quite at look well and when some for regimen the looking agents data point actually with platinum blasting program. has same we some ADCETRIS which molecule as tolerable. the There is a

that combination can the tolerable make obviously safety chemotherapy agents. pass and benefits report and may the and had these So combining be But we significant our it safety sorts well sure safe. get are of additive we indeed the with to with

I we looks profile acceptable can As PD-X favorable forward. look focus has safety think blood that an from take from we combination but need the weighted that heavily in something looks safety are EV and at we cancer both what do that's towards commonly is used a other to particularly particular the agents research Clay an if any when then efficacy and perspective understand like indicated our

Operator

Oppenheimer. Our next question with Tuerkcan Silvan from comes

Silvan Tuerkcan

disease HERX strong Roche talk ADCs us a breast a to cancer a about the between plus? was HERX working I on what renewed know differentiators there is the . I option potential a different think and to targeting one. are in just you between And interest are deal been targeting bit let sales in there You want treatment but Could

Clay Siegall

a of cancer with that to PD-LX. little work a with the Seattle important sort Genetics same trastuzumab bit outside along you to if seems help and or be you breast very same patients. PD-LX with I patients will. and lot of what mean Well if with person HERX-positive I of or and used a would tell is in a And

ATL Genentech/Roche that looks a I HERX and So really there's agents think that one very targeted suit chi that interesting. tai

HERX. an looking really at can it patients. And help you drug for. think a that should keep think I constantly And that's eyes I roaches

I So have pipeline. your in what you comment can't on

Operator

from with Blair. comes Andy question next Our William [ph]

Unidentified Analyst

line second physician Just question the have a on adoption.

So probably for a Roger.

upfront? regimens terms Guidelines can think Steve's or regiment earlier you of In EX Astellas that a lot to of these do the cop these retreatment for I plus actually NCCN you be upfront question go do the added think or the mostly Or combinations? are two think to get ABVD a about given on from patients plus

Roger Dansey

the made Yes, think lymphoma. Hodgkin I treatment to appears the very be with was in earlier that ADCETRIS point

them circumstance therapy results gap recommendations. is indicated between cetera obviously is encouraging outcomes the reasonable as committee smaller and both sit wherever Nebo therapies of as governance Clay site earlier ADCETRIS there individual in acceptable. initial but we has The So et monotherapy following having worthy of of and those considered the very treatment and they are then a

and then someone for frontline to ADCETRIS in think getting it's EX then reasonable having a If again the So the and very getting idea exposed you're. of that's example concept. what I a an entirely relapse

the I be should that tolerable. think you would regiment expect

Unidentified Company Representative

And also emphasize that bringing of context rates. to you also the Is these in CR the transplant eventually? patients

Roger Dansey

Exactly.

and ADCETRIS think a prepared agent patients is head with I a tolerable into high need in as exactly transplantation. CRAs in present circumstance to they mob as a remarks. you heard ADCETRIS is Novella agent is results tolerable remarkable the and be which

patients. providing you we a obviously good lines the think offer So may what up which outpatient post-transplant need statement outcome to salvage an is have you for

Clay Siegall

you long-term treatment ADCETRIS is a they have CR remaining what that you bite to need at another are this population offers it's that or have a that first extraordinarily And we into direction. are do and then go do higher a a the want Hodgkin than your a most want get high. with to to survival apple and if offered. for transplant upfront is And ADCETRIS patient want at ADCETRIS when ABVD that's patient in And you what the cure. rate with is Andy, to you a lymphoma year if regiment. evaluate And what your small disease-free what also

of lot substantial a amount patients So different Hodgkin survival. meaning with these have if Hodgkin lymphoma die options something. patient disease-free ultimately time.And into could ways you lymphoma. get lymphoma And of be in to you're we to the they really And the last could Hodgkin of there can get are don't these you people long-term cure die a of with all cured two so

patients. believe redefined Hodgkin more lymphoma a see exciting end so to how is really and it of to how up lot ADCETRIS me treat curing you landscape the I And we'll has

Unidentified Company Representative

the And brought just completely one call thing; resolved. am I during about this correct in that thinking QX manufacturing was issue up that

Clay Siegall

comments? issue. would and and XXXX countries around since of so am do regulators ADCETRIS remake drug. had batch with it to any supplied do you call to this. we to And figuring that We're pretty working any have many manufactured a without XX We reported tell you failure I one Todd at will the I that good globe.

Todd Simpson

there let manufacturing on We didn't go. supply threshold have us all a never that had have doesn't batches. we that quality release in inventory. But that QX a a interruption them substantially And wasn't was a place issue we even There now we put happen closer and reestablished didn't that. meet few when took to

So we're in good shape.

Operator

any have remarks. for back no to closing presenters queue our the Around turn questions conference this we to like at And the further time. in

Clay Siegall

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

Operator

gentlemen call may now this disconnect. and Ladies concludes today's conference you

Seagen (SGEN) 26 Apr 192019 Q1 Earnings call transcript