SGEN - Earnings call transcript Q4 2018

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

Operator

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

Peggy Pinkston

good and operator, you, afternoon, everyone. Thank to fourth quarter like welcome call. all Genetics' Seattle to you and of I'd year conference XXXX With Officer; Siegall, Todd Clay Executive Vice Officer; me Chief Cline, today Officer; Commercial. Executive and President Darren Simpson, Dansey, Roger and Financial President Chief Medical Chief are flies, call Presentations on page. are our the website today's conference which section, and Accompanying in Events or supporting available the Investors

included the right XX, on the filed the exchange with may associated the regulatory revenues faced reports the the XXXX, a December the future line and include quarter and XXXX. achieving including Following or development forecasting company, for ADCETRIS, the future in Today's quarterly implied uncertainty others XX, and including Genetics our the data we'll is ADCETRIS forward-looking report risks filed Form year and Seattle on may and future outlook, and prepared the published and will future or cause the vedotin, regarding Actual those remarks by caption in enfortumab relating information milestones, sales, anticipated financial projected conference the clinical for commission, or as in potential Factors, sales and cost expenses financial is revenues; forward-looking company's expenses, by future to the annual open statements regulatory for difference the includes the and for Form of and the company September about report and More materially from events developments company's Risk approval factors results today, the call such these uncertainties ended to performance tisotumab including ended the those XXXX process. XXXX pharmaceutical question. securities the tucatinib differ with difficulty operating that and company's XX-K under vedotin. contained such report Among timing periodic company's and statements. among XX-Q anticipated company's periodic

Now I'll turn the call over to Clay.

Clay Siegall

XXXX year, was substantial progress a indications is with ADCETRIS of was therapy achievements becoming Peg, closer company. good becoming launched Thanks, two In a everyone. oncology to by significant frontline ADCETRIS in multiproduct CDXX-expressing bringing XXXX, and highlighted afternoon, remarkable in clinical us lymphomas. our the portfolio, late-stage foundation and and

We expect to in including ADCETRIS growth. XXXX, continue our focus maintaining momentum commercial on

three our are programs ADCETRIS, approaching solid late-stage that Beyond near-term tumors in milestones.

after and chemotherapy Importantly, the And lymphoma, with Hodgkin mid-November, combination based on we'll for Therapy peripheral in vedotin IV positive data lymphoma, PTCL ADCETRIS chemotherapy trial. tucatinib. approval CDXX-expressing based designation, approve from a and in combination lymphoma Hodgkin $XXX front-line in days sales and sales submission the in U.S. with III XXXX, bringing the ECHELON-X in ECHELON-X T-cell on net March, was with trial. In pivotal Breakthrough the increase The a from contributor XX% FDA's was with report to came net oncology XX over results was strength pilot in to of to need. million the commitment collaboration is in review testament XXXX and U.S. close XXXX, and approval under our real-time of a in FDA Canada. record the we program. achieved XXXX. data, patients frontline ADCETRIS trials granted enfortumab approved then primary in to ADCETRIS In Stage This in

year. ADCETRIS be million, in that Canada $XXX and range the net in last XX% XX% of sales $XXX an of will For XXXX, million to the over the we U.S. to estimate increase

sales exceed populations the expanded $X provided by and XXXX. with the labels reflects patient billion ADCETRIS of new indication in in Globally, care. frontline guidance decades standard could Our old

lymphoma year. based approval health later to in to lymphoma Europe, in plans this is approved was front-line EMA EX ADCETRIS other the data and frontline for continues Takeda Our partner September. authorities on great Hodgkin territories. and trial, Japan, EX In its progress to Hodgkin make pending tucata In submit in

solid Turning late-stage programs. to our three tumor

partner We to expect quarter. the top urothelial the for EV, are a report trial data next in data regulations drug. line These XXXX approval regulatory preparing several the path from metastatic pivotal upcoming support our we enfortumab in vedotin on With our accelerated Astellas becoming submission a cancer EV milestones. or marketed this FDA's could under and for to

The stage pivotal have Our primary endpoint the XXX is to trial. an patients HERXCLIMB, kinase we of targets that oral tucatinib, is which second completed trial enrollment analysis PFS, program the late for tyrosine inhibitor the called, enable of HERX.

to HERXCLIMB into tucatinib other expect program our intention and of into cancer HERX-expressing breast further tumor data If is report Roger this which year. lines a broad development build successful, will types, is outline. We topline to earlier

Our we're third is vedotin tisotumab or stage Genmab. a TB, developing with program pivotal which partnership

FDA's where with an submission focus support accelerated initial path. is trial Our ongoing to conducting are we TB the a regulatory cervical metastatic approval cancer, designed under pivotal

parallel, by lines and In in are to we tissue complete cancer tumors expect mid-XXXX. other factor. solid TV cervical express We enrollment that of other evaluating

we're targeted late cancer, multiple for addition therapy, in I development myeloma. II Phase ECMA, that's In ladiratuzumab an vedotin multiple breast the programs, developing triple-negative and development empowered state Phase for a in ADC including antibody to SCA and

additional during of in growth. key strategy agents We our XXXX treat INDs expect our Investing part novel future to for also a pipeline to is submit cancer. for

have over better in are people note, comments both U.S. progress lymphoma and our Darren? discuss in Darren collaborators well commercial After accomplishments in relapsing making Of that, Roche B-cell call approval this We new point, ever our progress they that ADC large activities. the At with to EU. will our Todd then bring Genentech clinical to cancer. Roger to provide results turn financial with And will XXXX our XXXX additional programs as believe our using view on I'll the XXXX guidance. than for pipeline. medicines and also XXXX to as submitted expected technologies. announced [indiscernible] that Our in our

Darren Cline

has That will opportunity the Since care strength and approved for U.S. vision. up in settings been that the execution. achieve commercial Therefore, the were used sales frontline the with of time full in to place. Clay. frontline ingrained our we the we a $XXX and blockbuster U.S. chemotherapy expedience Thanks, like position on of launch treatment become build that clinical fourth sales into us our vision the ADCETRIS the further bring in significantly million patient against in that said, team in XXXX, in confident $XXX a In XX% the approvals approvals would broadly I our frontline frontline and we we're million quarter regiment Canada. brand is X indications in trials to frontline ADCETRIS The habits. to context preferred solid the are for addressable have based the choice. to commercial and other data XXXX, continued This the with and based number growth. opportunities. vision in could XXXX, over ADCETRIS of achieving take long-standing expanded share The year were around ADCETRIS - net quarter standards XXXX, saw additional of physician of some both XXXX. increase the from

start me lymphoma. with update an Let Hodgkin front-line on

approved was patients. this you for IV III As March in Stage and know, XXXX

editing. may to awareness build who main marketplace and potential both and continue with per familiar establish we second, in community regularly its its view first, few centers. year; three for quarter, as ABVD. will We ADCETRIS full use treat have take academic and in physicians product Hodgkin patients and are to It having the the with positional to patients and ADCETRIS segments: a a lymphoma; see fourth the only the effort of During time physicians patients lymphoma do appreciate recognize who continue profile third, Hodgkin who not ADCETRIS, that their but benefit to physicians

is Our we're progress. physician these commercial of shows intended to plan and research our profiles, each making lead that

IV We Stage accounts. in continue share This reflected over increased diagnosed an ordering the quarters market new in X in and number last and utilization of improvement newly the is patients. to see increase III

are continues growth strong. our to lymphoma the and Importantly, where treated. be community frontline Physician majority practices we've Hodgkin of of in messages key seen recall patients diagnosed

also that access data. the We ADCETRIS physicians to focused on are ensuring have involving

For with with that to data additional trial in of the and example, support our result avoiding can from American treatment provide were recently important data are the efforts along while align neomycin. factor evidence EX These associated guidelines toxicities growth data the efficacy, label. North A+AVD part our prophylactic superior the published. with These an pathways

our on most approval comment I'll Next, frontline PTCL. recent in

ready. As rapidly we've know, and commercial the disapproval was team submission, you the following received

the into hearing early the into the consistent resulted of including of community, we in data efficacy ADCETRIS advantage the the trial, conclusion A+CHP in guidelines The is EX survival. in the data still significant are the December, regiment, that label. positive reactions improvement the EX overall in from launch, using NCC physician with the and While shown to

the that Our unmet that for trial patients goal regimen CDXX-expressing EX In improve and is to patients EX leaves of care belief chemotherapy an frontline become lifecycle a CDXX-expressing product lives choice exciting brand. is lymphomas. the have on indications. ADCETRIS will U.S. time This the of successful with the standard the our that believe a conclusion, PTCL. can trial CHOP PTCL believe the ADCETRIS impact the the the A+CHP The of frontline of we significant need with in become meaningful We can supports that new in upon in for decades-old patients

indications. our also will efforts We the labeled X other continue in

goal both forward patients Todd progress. to call for look turn to to financial our over is and results. ultimate the I'll you I Our discuss now updating our on physicians. to

Todd Simpson

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

progress year, record in ADCETRIS and for summarize full also financial quarter our the of this pipeline, In and XXXX fourth U.S. fourth and revenues sales. strong the with financial our sales million, making XXXX I'll in quarter Today, had achieving provide a with Total milestones $XXX stage million. for were included and ADCETRIS with financially net XXXX. substantial year addition of to the $XXX our important results late then ADCETRIS Canada outlook we

sales expansion increased XX% million reflects including revenues increase to in million. For XXXX, Royalty in in the of $XX revenues $XX to The million compared in quarter Hodgkin label front-line primarily the net fourth in XXXX $XXX were lymphoma. $XXX total million, of. quarter the year ADCETRIS fourth the

million $XX driven who ABV, milestone in Takeda million ADC for continue XXXX. revenues sales with were in and primary year and These For These revenues deals. revenues royalty the revenues full amounts to supply and our of fourth also XXXX. from Collaboration to GSK make supply primarily $XX ADCs Collaboration collaboration the to under the by our $XX compared territory. technology. $XX each as its earned These to reflect chain. who collaboration earned increased progress increases million Takeda year reflect in The Takeda reflect included decreases to ADCETRIS quarter transition revenues like for stage our are development. the million sales with Roche, XXXX, higher that in our and reduced Genentech XXXX late payments programs their product own partners in utilize

under ADCETRIS addition approval the EV, pipeline, in these million XXXX. quarter in and notably, fourth in fourth In million $XXX on and first deals, and for quarter we stage increase were rapid activities The include SG&A of frontline XXXX. million The milestones the primarily of $XXX technology XXXX the reflects expenses in the our and XXXX million year to are program the sale's the for the expenses tucatinib to year. reflect R&D mid-single-digit the range. fourth XXXX over of products $XXX launch the SG&A higher in year investment quarter PTCL. receive entitled TV. also expenses our in were in future in in licensing late $XX increases royalties across quarter

$XXX for common of launch net the million and at this year and in shares financial an These acquisition of investments. the which operations. and $XX the our XXXX, year note, of cash Cascadian in Immunomedics front-line the variability in contributed are stock lymphoma. included causes holdings associated investment in ended cost $XX commercial Hodgkin of in This for loss million to is gain full expenses our end with approximately results addition million. $XXX the We a of is the to with For XXXX ADCETRIS Of in the year. and quarter not in mark-to-market, to core million

expectations our revenues total million Regarding a anticipate three first, components of expect range to are $XXX revenues: There main front-line and increase million. $XXX net the including range of ADCETRIS our to the our financial we Canada be sales Hodgkin we to and for million. U.S. guidance in for XXXX, million firm reflects in lymphoma to our $XXX to $XXX within to frontline growth This PTCL. labor,

based the to - anticipated in upon $XX of revenues sales in be range the million, ADCETRIS Second, to territory. we $XX expect of million based royalty primarily on Takeda

see Takeda from reset the reminder, the beginning based the collaboration sales under year. different and the of $XX million. of reimbursement revenues we [ph] from approval U.S. Also royalty Escalade here on third, collaboration expect be to to in midteens timelines each than As license the what mid-XXs note range and has the rates the agreements we million in a in $XXX to at And that

expenses. to now Turning

quarter top indications expenses The this year data the $XXX tucatinib million our to SG&A reflects year. $XXX million. range to million be growth. ADCETRIS for pipeline be to $XXX the million. and as of to work LV also we line from tucatinib, as preparatory TV, approached This support of X This $XXX across to expect for R&D includes our this label We readouts well in headcount last affects EV the in in additional planned commercial expected programs. later increase activities investments as EV, and expenses are range

be to of cost of the expect We sales of X% in sales. to range X%

Aside charge in million the gross ADCETRIS in from reductions related margin some licensed that obligations fourth our improvement royalty $XX that to quarter did meet the technologies. process for not in specifications, in the release inventory took reflects we

As royalty a owed on sale. this a on by the of territory. will to royalty ADCETRIS low - percentage sales third-party cost decrease single-digit reminder, that in revenues reflects Takeda obligation Takeda This on is

expect As stage with year. we've late program our discussed this today, we progress significant

and updates regulatory resulting on guidance subsequent a that data interactions. As trial to pivotal we financial result, we'll based any anticipate quarters our provide and

Now the over I'll Roger. turn to call

Roger Dansey

upcoming pipeline. Thanks, Todd, and recent everyone. activities our Today, for development the good afternoon, comment on I'll ADCETRIS and

the report was in First, the there and meeting compared and CHOP in in data published an an ECHELON-X the were Lancet. presentations significance. The scontaining with An Hematology's clinically and featured the progression-free also results. PTCL showed statistically in in overall Notably, American practice more time lymphoma. to was All was plus than front-line ECHELON-X more will in XX endpoints achieved Also ADCETRIS survival points oral statistical demonstrated of and in presented, understanding long-term A+CHP other This continue resolution. benefit significant key December. we The was key at annual improvements analysis the Showing patients. trial simultaneously data both Society meaningful that trial of ADCETRIS of also future. XX presentation the CHP the data maintained which These with changing the presented with EX follow-up data Hodgkin at PSF years. where updated months to the are on important appropriate for of to - benefits on at in three unprecedented

Beyond a standard such combined two where results evaluating for chemotherapy the in ASH less trial combination investigated XXX% XX are a inhibitor chemotherapy, EX and and toxicity agents of lymphoma with no PD-X a avoiding ADCETRIS by follow-up chemotherapy using EX, tucatinib progressions and/or use of trials regiment after activity months. Support produced presented successful patients, opportunities the combination increasing response with of produce adriamycin either with without median XX early-stage development ADCETRIS we Hodgkin frontline something started reducing where and as death for of from at of was thus something rate three nivolumab. with comes rates. the [indiscernible], This fewer the drug in

a produced move vedotin. I and in lymphoma the and patients, rate inhibitor, lymphoma to the relapsed For PD-X rate relapsed and line was that complete nivolumab response XX% response and of in objective B-cell ADCETRIS will on combination XX% an a rate response enfortumab now Hodgkin collaborated showed primary patients. XX% ADCETRIS overall second

FDA being EV-XXX, platinum cancer at is yet line to cancer. pivotal this respond meeting supported with from next trial, been improved the Breakthrough in PD-X week be from currently study local with designation Therapy for Several or metastatic colorectal ASCO current PD-X trial focus I PD-X patients, previously and and of inhibitors Our updated results The have phasing events do patients and therapy is PD-X options. directly XXX inhibitor. and Phase second the at checkpoint new not colorectal many need and who metastatic treatment will Francisco. inhibitors EV treatment San EV Data received inducted GU

[indiscernible], this As Clay XXXX. this we in we believe result a with in which to first-line is of a report could from on which track incorporating and results of a the generated are the combinations, Data standard inform line has PD-LX To of provide clinical EV-XXX something frontline trial second the with trials the end, Metastatic cancer treatment to PD-X, with will our standard quarter, combination are are benefit combination we earlier, of conducting agent, care. different in from during other line current care regulatory patients mentioned the and potential submission with therapies. date EV these this platinum combination in which registration cancer first to number with strategy. in along in agents,

potential other expression considering believe also something and developments. given We tumor future profile of are and EV types has

Tucatinib in Next year court is selectivity in pivotal tucatinib is is that and selective trial makes in HERX to this best-in-class trial primary Ki. Enrollment priority with be in has PFS data for for inhibition EGFR stage therapies. patients we this of in late tolerated. later and combination HERX rash RO tucatininb. on potential to XXX rental HERX-positive evaluating report targeted received or other HERXCLIMB, continues to patients breast plan the brisk, something who which placebo endpoint patients. be the HERX to with something highest the produces meaningful HERX our our of In which diarrhea, without pipeline has and less this affinity program, such high and as difficult It a previously

well with We to in of of secondary patients as up as In patients PSF of XXX a brain metastases. overall endpoints support anticipate to analysis addition, the total we accrual HERXCLIMB mid-XXXX. by are completing to survival enroll continuing

Assuming searches Initial and data gastric with opportunities are trial further cancer tucatinib tumor HERXCLIMB, patients. cancer. tucatinib standard earlier in breast HERX underway multiple cancer setting. in from This with combination HERX lines now we assets in something positive breast adjuvant develop positive the for see the in included to other is of already treatments near

are For In improvements. together of X evaluating [indiscernible] likely progress there ADCETRIS in important third is with call X year regulatory busy when lead put see that, back a trial pivotal lymphoma, XXXX. submissions patients may data is we to year additional XXXX ongoing and approvals readouts I'll the conservative turn with cancer, preparing in was ADCETRIS the drug another investigated clinical pick Clay. line and follow tucatinib an trial, potentially that closing, substantial new We of genetics. it a for to XXXX HERX With in time with with positive to over regulatory tumors can opportunities

Peggy Pinkston

the a expect ahead, to Thanks, care lymphoma year globally ADCETRIS Roger. in make Key the to an as grow establish becoming In XXXX for ADCETRIS state multiproducts oncology in and PTCL. progress significant brand ADCETRIS program, standard Hodgkin frontline to we continue and first, towards our include: and activities expected of company. front-line the Blank pivotal

line top EV this from submission data year. later the reporting a potentially Second, cancer first pivotal enabling trial quarter in in

cervical Third, reporting for pivotal the call trial At line questions. the in for lastly, HERXCLIMB. please enrollment open pivotal we'll TV this top And open the point, for in tucatinib trial completing line data by Q&A. Operator, midyear. cancer of

Operator

Instructions]. [Operator

Capital Keenan first question McKay of from Markets. will our RBC take We

Kennen MacKay

million sort be get a $X around of increase, sort $XXX we of, the around bit rate given million. quarter-over-quarter QX, wondering run more to the May little guidance, if we helping color

to quarter-over-quarter about from million Or versus, coming guidance relational meet we're issued? should that population? thinking in of we get to going QX? to that EX $XXX again, you so a where incremental sort sales the the from the saw in sales that where coming And we be million $XX to Is

Clay Siegall

Yes, thanks, Kennen.

should this the mind of build and great. awesome take we're the it progress. the this increase doing an and We're regiment, or is incremental continuing time market then going and and uses will in [XXX of with the great the includes EX and for So into Keep to really challenge, what that EX And includes say, persistence the penetration - it ADCETRIS EX regiment, EX continue XXX], drugs XXXX. drug. that's in to so to guidance, we're But less cycles I up it's population. launch, a making to is

Kennen MacKay

more of versus of May been guidelines be has dynamic that behind how the previously there previously of changes Is refractory been been can being terms now follow-up. [indiscernible] There setting the in color recommended any us factory give it's a and some sort current therapies. or prior checkpoints quick affecting terms had settings? sort you of with recommendations in three

Clay Siegall

I'll it that. Yes, turn over to to sure. Roger address

Roger Dansey

Sure.

Hodgkin you have as certainly lymphoma. a role PD-X So in inhibitors pointed out,

it's he I to think all lymphoma the the refractory as ADCETRIS, almost has play a Hodgkin from It role indicate, of Clay stage our has drug. every frontline view a a of great disease. way to approvals little

that the therapy remain We so end. And all from other is confident yes, lymphoma it's used broadly front available. to good, be will Hodgkin way in to that ADCETRIS the

Kennen MacKay

after you. wondering can from just duration looking cohort cancer. going get to Phase data on very what to [indiscernible] I survival. responses to maturity if I'm of a much that. mature I pipeline. kind that do, And we're Maybe noticed referring something in or follow-up Got that's if the forward imply the one there's of you

Clay Siegall

Phase I the from study. It's

it's all about to survival at It's safety like this and So things really the the the premature that. responses, talk point. duration,

Operator

Our Barclays. Geoff of next from will question Meacham come

Geoffrey Meacham

on the early Just out, among that any give population helpful? haven't the adopted are? start commercially, will you anecdote to I'm And and docs? the maybe give have, it's curious us sale if new ones I in on can PTCL be guess, that. figure then utilization what know what on I'm adoption the can you trends EX ADCETRIS I mattress and any metrics community there's trying percent

Clay Siegall

the see more that's the continue We're so that, on, we for but More specific community you this and docs taking regiment on that. using numbers EX community good. see providing Right. we really to docs not and are more

and is facing market approved. penetration, have increasing it's we are And we're is and other it that with regimen in share we convinced docs market say been our I we're be where on I ABVD away, docs And using is to years that increasing up, them. data we for no, right doing a direction. we're before and some it's "hey, we're there working right the giving have was using we're decades. benefits want increased out us. data just and got with increasing the take better that. using and EX And that the new them It's are This the going a But docs for there's with showing there XX connection is not regimen do." that need ADCETRIS accounts, of better docs We for still the This there's what to patients.

And that take to bit of continue our going so get we a we everybody. time. to little It think efforts, we'll if is

pretty a With You give therapy. PTCL, we than in PTCL the chemotherapy. little story. have patient's chemotherapy results nice not results pretty ABVD but And good great than responses. half immediately very of different also more asked chemotherapy about more got after results, Hodgkin CHOP is a patients, patients PTCL. to PTCL, success good lymphoma. are CHOP going half where great pretty responses than that

data against. to some that part data of - is which the go great, was we so but not is good, had them Now ABVD relapsed, the of initially

that it's had the We we mind, more approval but as so then in more declining when patient we end regimen there faster charge while, PTCL the year, to using and whole upside of put keep charge using more per docs as And don't the is and it for on So patients them all they and an and has are incident we happen. the with once. the there a from dog to more time it, serve treating T-cell docs. towards then identify where great patients each to get first population flexibly the for protocol, start send lymphomas. stuff to far at

it. every they can get so only at totally it in is that on about - mind, weigh. And regiment, it's time. are and it you higher excuse place you a cost, could based EX patient $XXX,XXX. we just under so EX more understand for me, about keep lower, EX building or regimen $XXX,XXX. And to average like this Please much with So be average or much regimen, the how the $XX,XXX to The

So it's because just of number they there's drug less cycles get less there.

ever that So equal if we regiment there long always to difference have is but of we the time. for going from even do dollars I've EX had that the less patients, a number discussed a and something

Geoffrey Meacham

guys just And the take duration on curious approval meaningful view to what follow-up and there? of earlier filing if I'm XXX. data. ahead on good topline you're feels stab just Okay. as question pretty feeling, clinically a always ultimate an language The can a you at while you or

Clay Siegall

that. The Roger cancer approvals talking were the add color Never wants approvals make any last EV between you pivotal if see ORR. trial and different and based were rate XX% [indiscernible] in on endpoint to for primary about is checkpoints, And were will the I and for to XX%. one response comment

XX% data I leader trial. response, the came from our in we with XX%, when lot room Phase in had a we or our So so at from objective of trial

Now Therapy pivotal reported this the very strongly we we yet, haven't with data data about our but data. quarter see trial don't designation. the the got it We on a will is. data feel have And Regard we you Breakthrough

feel very we Roger? good that. So about

Roger Dansey

the is initial XXX one add signaling And based trial comment. the I to Phase patient. over Just

of that robust of in bladder cancer, excellent. for rates context number response being results the was it's So is outcome the in a placed patients

seriously make what - should that think to reach we considered really in to be the I Phase that I, to confident something argument regulators an saw drug we that we close so And this if pretty we could would for is use. be

Geoffrey Meacham

clear, be to FDA in the about PFS ORR' just considered the discussions, ? it's But still OS weren't and

Roger Dansey

of an outcomes duration approval X That's the are and right. and This is approach response. overall response accelerated key

Operator

Michael next coming of question Our Schmidt from will the Mr. Guggenheim security. be

Michael Schmidt

I few wondering of we've for at the I the with file and if just study? the tucatinib. on could used the then in to you may were cancer initial And would Difficulty]. had you be, couple OS recently follow-up that the PFS breast are share And a baseline data HERX PFS [Technical us planning seen space. was here a positive trials whether to assumptions on HERXCLIMB power And the be

Clay Siegall

Michael, you phased we And before out at kind got the phased of question out. you think I end. the there

were could and was XXX on able we OS I HERXCLIMB. the that. You and to based about patients? asking it like And submit PFS something think be

Michael Schmidt

That correct. is

Clay Siegall

Okay. you. Thank

So endpoint it's and primarily absolutely, PFS. at - our is XXX, we

excited this trials because that We fully the really XXX, tucatinib and comes is have lead-in really activity used and in we have that a exciting tucatinib enrolled forward that. So historically. data year of think and to we're are in trial the we that looking other seen to drug

We excited profile, because with not with very interaction HERX, best-in-class the and differentiated, potentially are It's [indiscernible] a with of it's EGFR. but clear that different. also safety totally very

to this PFS. HERXCLIMB from So that's there primary hope it's a is first certainly that the out that patients come - one-of-a-kind data it's the endpoint best-in-class. improve data XXX going And we the to of take and set with really

Michael Schmidt

Anything and be PFS the HERXCLIMB assumption study arm? control specific treatment the on for specific trade powering may you for can the

Clay Siegall

never and was all lot assumptions how are. normally study of But why what don't talk facts. We that's data the assumptions assumptions underlying patients. on we other the there of that In available is about our treating this make sets case, not the cult data HERX-positive are there of a the power specifics and to of perfect

have not patients data available are think to want populate, it's used trial was look you think to that's think I to of We docs what going to I to the be it. in patients take. do and how to to trial are so would designed that is do that. going Or... the something something read and minor, help have minor, and Roger, that just doctors meaningful that differences us really to the at to minor best, for make the how And most want anything our you It's to design? use want to all drug. add we

Roger Dansey

on TKI design, arm Clay's And adding a control we're is thought commentary, a commonly of I No, simple is to chemotherapy. a it agree. top just to design. well of it's plus The add-on HERX this is used a where and add -

a should able that. the colorectal it tucatinib of to with in if also a we demonstrate an of population, this really effect that cancer, which So believe should only population area to we metastatic but does, treatment able has higher-met is be need. general be Not patients trial -

Operator

Instructions]. [Operator

question of next Goldman Salveen Richter from Our Sachs. comes

Salveen Richter

line existing With trend for ADCETRIS, same frontline, demand regard for given study the the in to first curious regimen? PTCL just should whether the pent that we up expect just

Clay Siegall

it. by over Remember, the For Would talked wasn't existing and about away get we a as to it going lymphoma, there this just an if that regimen were an is and of that. pent-up population. because containing what ABVD that want is few But transferred pent-up PTCL bleomycin is didn't docs was ABVD What for less and people there regiment it be meant they as protocol, demand, population. and over, toxic from then really some that's that is demand. you that's a there on had to we've incident a from not PTCL, incident With chopper regimen. front-line at the transferred finish Hodgkin

been of really little But that. of a that might have bit I to nothing think mention.

Salveen Richter

then for the know to with secondary tucatinib, the adding another regard you're and patients, endpoints the XXX data to And NDA? Do those OS. you from need file XXX XXX study and is I core

Clay Siegall

we time more finished come being the we We decided the had that the out brisk. that and to XXX between we when data was going enrollment so and wanted since data to have

we to brain to want really secondary why the mets went and we two and more OS, said, were look reason to we'd to endpoints: so one we the one at look because have off half endpoint, patient's. to other XXX, was enroll being primary to two more at mets to OS; not a brain we the which wanted look we and data patients can at FDA always with mets the things, So look, only of look brain bigger

patients So at it gets additional look us to bigger a pool.

the on XXX. it's with going be So endpoints, the primary no really based to

Salveen Richter

From of on one PD-X study. I'm With regard how HL, read HL forced last the in an Mike's about question. that comment just it's do keynote curious to the label. you duel context having just And you drug your in earlier expect use think about impact. maybe

Clay Siegall

now understanding, it we're initially was for Okay. quarter, in study, in The and keynote they it the it fourth hasn't read-out our would tool February, read out.

and want Clearly, really comment best I the the don't options I we specifics know the Hodgkin for for other the on can't first different data. foremost, and of I so So and lymphoma data want patients, patients with lymphomas.

the very - So XX% of plus showing than we of ORR agent, have nivolumab get that would more patients. way with rate in them best we this very probably relapse data when PD-X or is Brenda setting, have a not response CRH. To bendamustine I patients. the treat relapse both really What we patient us, and and I hope have is the it I ADCETRIS single the is best. a into ADCETRIS help with can for high mice think say And and you the high very high

doctors data data going are point when don't such based this I make So at that combination on strong available. strong decisions data is agent necessarily to more and much think single so

other one in different and including add will now use is with drugs ADCETRIS the thing We right combination of bendamustine guidelines in reimbursed. that

Operator

question next Andrew comes Leerink. SVB from of Our Berens

Andrew Berens

I question. had a

that the it in expected? diagnosis was a was the couple is numbers, the it mentioned QX wondering of the well within was impacted Hodgkin's. guys of which call, to that previously? I seasonality you of have return one what Or During things still

Clay Siegall

demographics Hodgkin does the talking up XX-year lymphoma, happen When I'm go - things of of States you patients, these a it kind over back about the it down and with in look and and United numbers. period

- or but mean, the know the raising exactly diagnosed. it Hodgkin It's to the it - is in and decline, hard rationale a is. next it not Whether year, ups it's on years. I and starts Over the backup, diagnosed huge the you've know, over a don't and obviously gone patients why it's for good for the we down lymphoma in that less last there's people U.S, U.S. years, it's each likely few very not a seen has downs few years. declined year

on right to different patients like are little where it want when more diagnostic So the it's immunotherapy that's It to go and see one diagnosis some holiday that. seasonality, to the a other and relates periods on depends quarters less. how on and the quarters there things thing and you

hear the from it short, So docs. of seasonality patients the our we many

your and question. I goes So hope that addresses

Andrew Berens

get since is the to with then seen And imminently rates? had how have headroom a would of what bar I the saw just question competitors with I Okay. but you and the much approval I question sense it's you you do eventual think than in competitors or in I asked coming like probably FDA somebody between much that just I guys compounds what lower is - already there Phase what a Phase response the some or of the accelerated

Clay Siegall

in getting we with from the line didn't In any work in our see [ph], FDA sand regulators. BTD

get. mentioned things: the I Roger three things, of one well, the on think they are lot interested response is the briefly, is one And for you should that. last ORRO one of I - this: the in we the rate, a one, duration. clearly But safety And the drug. that is information was say have two

that's important. really think I

a and We've of doesn't good docs, the patient If much high using attended good in won't FDA, leering as trial. you drug care the duration duration. have drug rate have our a very seen response duration,

that, like don't is in between we to exactly, saw what the ORR I vision to I of a trial of the we that the or is, with in excess mean, patients. well that of on were of is when leering in think a duration, we think bottom -nit X just long want setting the rate our what relapses So see what this some I line time, months XX% was response we patients FDA, think remember the was and close approximately the for something

we don't number give you we don't I So - want is. number know what a know I of don't us because it the a haven't just bottom they I to told headroom. lot of have FDA think what

approach also know EV that I I notably, things They the whole Most something we studies So the don't going to on. want in see would combination that. package. established have with other enrolled like say and something data and presenting is a we because we on to forward really up have been that look interesting in getting earlier with something well that therapy. we think that to

Andrew Berens

question. Okay. And one housekeeping quick

a $XX.X you some ADCETRIS, another write-down, something continue? wondering it event? more color is a assume. on Can of had I is was You Or could I that And that onetime give it million it. was

Clay Siegall

Todd?

Todd Simpson

sure. Yes,

related manufacturing our specifications. release thing the infrequent a large us. for I actually we've of They the time it's ADCETRIS. This need didn't is So lots think very were first had that

product It took would chain. got was basically that them them we inventory, the of So most process. This off. supply add into out in never rode I

I wanted it impact not affects ability first time think in today didn't our it So call did was the it's patient included is to sure happened million about it it but the cogs. to make $XX because charge was the I that out

Operator

Our Cory from next comes question Kasimov Morgan. JP of

Cory Kasimov

about all, currently is drug kind PTCL at the roughly within you initially disease sales can break for the the contribution or or to are of EX of from been Anything First out say least where you relative used? frontline PTCL? able full results, different perhaps sub-segments of

Clay Siegall

closely report. But that something pick started not hard look of that just the to to intend precise it's hard like best we can, that, [indiscernible]. to it's as docs but that best be as at say dynamics and will to as can marketplace very the track that's to are we try I we understand we what we really the

Cory Kasimov

in PTCL But sale? do contributor the Okay. to a quarter, fourth of was terms

Todd Simpson

Yes, The XXXX But it mid-November, very guidance. let had so in pick. approval our to included me jump QX. likely modest is certainly came a contribution in

Cory Kasimov

what about done had that was holidays selling and for talking might those X X that stuff like contribution reason I you the relative a ASH, with the the - been. and month I good between like was even asking, have was what you've markets. job or And days that's EX, for wondering the half, like But differences The that? and

Darren Cline

Yes, Cory, it's Darren.

too are some it, X- indication Clay's the to this we but had, will point, And right. the got we at in look point. launch at early exactly selling We it's days. You

Cory Kasimov

that? in like Okay. kind you potentially a curious project. early-stage for as could testing What study using lymphoma. the about of next question maybe endpoints Hodgkin I'm potentially ADCETRIS

Roger Dansey

you. Thank question. great a it's Yes,

potentially that So around we our way working still are like. look but can

outcome obvious take time. the lymphoma could with of trial concerns a a very very large early-stage long for One powered traditional a Hodgkin

various we are meaningful a that ASH. plans data thinking generating ways It through are no be like pretty audiences it thinking potential have that there are looks compiled proposition we but presented thoroughly but So for show inclination was at we of through. the appealing other will by to

Cory Kasimov

one for on modeling question of guidance. goods cost a Last Todd, Okay. the

I this historically of when year, there this changing been as that result well? falling X% believe, royalty of to north the that off? X% else Is it's all is So XX%. Or something

Darren Cline

No, XX%, been X%. obligation of in result of And if on equation, term. comes down X% take sort to range, we've you write-off run the or that's largely of XX% the the the sort that that's running of it's technology - out royalty in-license that's now some

So we paying longer are no royalties. those

Operator

[Operator Instructions].

Cowen question comes and from next Peaker of Boris Company. Our

Boris Peaker

quarter First Hodgkin lymphoma.

what agents of over versus talked about X the patients history fraction prior and docs the lack community docs on docs? treated for decades. and just commercial strategies variability approved of are Hodgkin curious academic lymphoma You've by of of community based the doctors community I'm

Clay Siegall

Darren?

Darren Cline

are in lymphoma of versus treated XX% frontline and community About academic diagnosed patients centers. Hodgkin

Boris Peaker

I'm do curious long patient's anticipate on PTCL. treatment? just how you on the be question to second My you. Got

Clay Siegall

up the the X trial, I was that to think X cycles trial in to were used. there In

Darren Cline

Most of six.

Clay Siegall

allowed Yes, of most to the most X. had up patients but were X,

Boris Peaker

translate to be it will shorter, or be that expect you it would do real-world? consistent? the How Would

Clay Siegall

know I how think to therapy identical it's would to It's never cured but patients exactly stay up. when potentially you hard I say to it. translate tend

Boris Peaker

don't Got this should increases to relative drug you. the Todd for I going historicals? Clay but how My the discussion we if around know forward about curious last I'm pricing, just price all think is or question, with

Clay Siegall

by on do our and thoughts we our what it. are would we start prices don't discuss I how exactly normally saying

want at anything to you that? have We brings. and looked drug. think add We what ADCETRIS ADCETRIS very reasonably reasonable we've for value the Todd, been do and to a is very that priced

Todd Simpson

and the think that something it I No, well. stayed that we says others environment Obviously, is many constantly. at pricing

So into do that take we consideration.

ADCETRIS having is to is world of you really profound pricing want benefit be. I patient like a that a in Clay pressure, think where right, drug provides

in a So good we've got gratified such that drug we a feel environment. tough pricing

Operator

from Our comes [indiscernible] next Oppenheimer. of question

Unidentified Analyst

Hodgkin split the lines patients and of along for question, what in the X,XXX the additional you academic community centers? say First lymphoma setting and of would front-line of terms earlier PTCL is

Clay Siegall

community. patients the to not probably Whereas the PTCL. With there's other like not with larger percentage outcome - of more a it's PTCL, in lymphoma, it's just as coming Hodgkin around way XX% is because probably strong

Unidentified Analyst

or on is the patients Thank HERXCLIMB trial. are enriched that that The you quick with brain post A patients meds in they question additional you. are patients, XXX enrolling just the something?

Clay Siegall

It's patients metastasis half of that them for click. roughly brain pre-existing have

Unidentified Analyst

on top that? guidance allowing filing you know what sign their after update line In I XXX give any EV the to you can and you're your we on an expect Therapy with of terms discussions Breakthrough designation off file order? on FDA but an Will

Clay Siegall

Obviously regulators of brought are those EV discussions and to and have a have regulators of lot specifics with We on with we confidential. continue discussions

So into give nor the will so sometime submit. we've soon, aspects update. usually at we soon then, from their like And this other guidance data, as timing some when distance line as point, to come we start have quarter to which on got top we is

days within usually As an unless part there's is XX of of filing issue. submission goes, filing

So talking based that's have. start about to ability the what we we would submit data on the

We have he year. to plans submit said that this

goal a given is our month EV specific but submit haven't on to We XXXX. in

Operator

[indiscernible] comes Our today Blair. of last question for from William

Unidentified Analyst

for segments. pieces how strategy wondering forward? your you probably it remind And different there's strength earlier UC inform Frontline can lines has any Roger. X eligibility all you us for strategy particular Clay would it's question longer-term a going in EV, just and there be that May probably status area if shown where different

Roger Dansey

question. Thanks, EV need is observations. of based Obviously a Since don't a on for any great couple biomarker. see however, we expression,

helps effective So broadly that we shows potentially can a the a and in exposed be a us generated population population data PD-X little that from express post Certainly, is has used. PD-X naïve been PD-X EV both using the chemotherapy. with with of at least combined is what have example, as in role ABC understanding together we a done inhibitor we something construct, PD-X great combine bit antibody can then a and the in

options. be such that be possible best of a mentioned the So designed move like of couple hopefully will number And trials to to what I've that's our frontline available times, we able choose to of considered into a have we've we looks appropriate.

Operator

Speakers, that Q&A. today's concludes

Peggy Pinkston

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

Operator

today's and teleconference. Thank This you, ladies gentlemen. concludes

disconnect. now may You

Seagen (SGEN) 7 Feb 192018 Q4 Earnings call transcript