SGEN - Earnings call transcript Q4 2017

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

Operator

Good day, ladies and gentlemen. Welcome to the Seattle Genetics Fourth Quarter and Year 2017 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Peggy Pinkston, Vice President, Investor Relations. Please go ahead, ma'am.

Peggy Pinkston

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 Executive Officer; Siegall, Todd Clay President, Research Officer me Chief and Vice Commercial. today Officer; Darren Development; Executive Cline, and President Executive Simpson, President, Drachman, Jonathan and Financial and Chief Vice Medical Chief are

the complete clinical and proposed delayed including due Risk and risks proposed a clinical we differ of data each timing on other events including from enfortumab uncertainties approval of launch these availability Therapeutics. with vedotin including regulatory vedotin Securities the and or planned may current clinical filings I'll inherent vedotin, to or Therapeutics well the of may Form uncertainties schedule that be after may also approvals, Factors, made closing legal developments get potential open If those others the possibility Genetics the or we performance Clay. is of questions. January trials, planned to conclusion sales and the case in to our related Exhibit to the unexpected and clinical Commission Following financial may implied Cascadian achieve net as events obtaining tisotumab the approval satisfaction the and to expected company's of call. call action. and outlook company's call on may in our actions, related the that included and XX.X intention as of among from offers for from regulatory of guidance regulatory More conduct line risks data all the over caption company company trial XXXX. Today's of company's prepared available remarks offer initiations, Cascadian process. the discussions and statements will the and and in today, enrollment acquire the and ECHELON-X, not planned or approvals product submissions trials ADCETRIS report a company's Exchange With adverse the costs for and will acquisition those, XX, financial your anticipated thereof the Actual such XXXX of include to about regulatory for ladiratuzumab clinical to will development, ongoing frontline its as contained future the the Hodgkin and conditions, anticipated questions, the unable or unable and information The the to and uncertainty trials, including milestones lymphoma, financial pharmaceutical regarding regulatory tender a as forward-looking of company's terms to uncertainty with we to in faced filed results be projected company, will on be conference associated that timing under the the Factors and be also are operating variety to revenues, the such The its competing future that, include forward-looking expected. expenses, possible statements. the materially risks cause Seattle in difference by X-K XXXX be reasons ADCETRIS turn

Clay B. Siegall

of to a cancer marked organization Seattle targeted developing from Genetics' Thanks, small bringing It's research Peg, year journey patients. and to becoming of good afternoon tens remarkable been XXth a everyone. ADCETRIS anniversary. a January thousands XXXX therapies commercial organization

remains XXXX, now for cancer are positioned key Seattle global oncology to two a to ADCETRIS In anticipate priority the Genetics. innovative company We become milestones. multiple products we bringing top patients.

data X patients of an excited and approval ECHELON-X oncologists ADCETRIS our from on and X phase drug lymphoma phase our advance lymphomas. our we Hodgkin making than enfortumab important mature in T-cell second, pipeline pipeline about progress A our is frontline reporting frontline advanced launch and robust tumors. with planned hematologic vedotin. based and in ever pivotal trial tisotumab ongoing strategic for are ECHELON-X Seattle And in malignancies ADCETRIS our the solid clinical First, to programs towards is it Today, brand. priority and Genetics or in is for trial. a stronger vedotin two trials, blockbuster

announced for metastatic we program tucatinib, Cascadian HERX-positive to and acquire breast vedotin. in pivotal addition, program trial cancer, promising cancer. is a we for breast And last which Therapeutics triple-negative their have ladiratuzumab an lead In week, agreement a

on would with us and discussed a within our activities Today, our discuss third upcoming milestones I'll to tucatinib pipeline As key our last conference program. fit global rights provide strategically programs. across week, call we and late-stage

exposure and of conducted that setting In positive common multiple we fungoides we our XXX who had dozens with quarter potential cutaneous E-X to of have conducting record patients diagnosed granted more and chemotherapy newly conducted ADCETRIS for meeting diagnosed U.S. featured phase primary ASH the and for across ADCETRIS the New in of in the cutaneous T-cell and previously represents session demonstrated of anaplastic from outcome that disease. advanced ALCL annual the show there reported XX advanced was ASH, also mycosis is cancer large data XXXX, This treatment the subsequent fourth we new and establish fewer on commonly frontline fungoides million. This ADCETRIS care. plus from FDA of were both annually assessment. ADCETRIS both most November data showed standard independent trials the trials, indication most is statistically arm, at advanced which to have We of December, and a to approved of Late the countries received the cures in in with E-X ADCETRIS and durable ADCETRIS AVD lymphoma. of regimen was ABVD, often arm adult in mycosis in Designation to data patients bleomycin. patients First, being in where is of untreated enrolled XXXX, Therapy with sometimes ADCETRIS, has primary the E-X lymphoma, phase we with received XXXX. tolerability cell including the ECHELON-X. remissions, honored the for indicate XXXX. England sales been patients be a young ADCETRIS significant stage year in reported we United goal the trials X,XXX lymphoma, billion We treatment standard global care was in for X $X the globally. The lymphoma. plus the a Hodgkin up favor Society combination to results and for and goal. investigator simultaneously severe therapy. the had in ADCETRIS-containing brand compared eliminated in unpredictable patients The Medicine. States. are the sites trial Hematology, all involved product patients long-term AVD first Hodgkin and globally. ADCETRIS secondary in in to FDA Breakthrough toxicity with of ECHELON-X These prior that are X,XXX trial. data diagnosed translate or investigator ASH, that X plenary of in profile classical believe subtypes trended support the At of than systemic to potential manageable Hodgkin cutaneous chemotherapy. initial approval approval survival people. of ongoing fourth to sponsored for corporate XXXX, the now The At and are ADCETRIS importantly Journal frontline in superior overall to the efficacy required approved patients CDXX-expressing of American endpoints $XXX the advanced published XXXX consistent in the approximately including Across AVD lymphoma one-third clinical plus that regimen in a the in sales with The in reported Primary Also

setting. to date with a that FDA X. a of submitted also January, Review we application and PDUFA FDA supplemental for announced this the May Priority filed In our We BLA

evaluating ECHELON-X often peripheral T-cell X to the could the ADCETRIS trial E-X in in trial be is of another driver referred future. The lymphomas. In with CDXX-expressing U.S. frontline PFS of ADCETRIS Approximately care of chemotherapy CHP as lymphomas, patients. plus T-cell phase in Our to newly important annually are standard growth mature in compared we the diagnosed diagnosed PTCL. CHOP trials, X,XXX E-X patients are

data the expect E-X to from trial We report year. this

The trial vast is in be or accelerated to is that XXXX, EV Next, pipeline, from three is the we most is which support the which FDA's I'll trial In inhibitor. of enrollment tumors, objective reported This checkpoint with phase under these approval patients late-stage for also global a X data Astellas. advanced locally Astellas cancer initiated intended the post inhibitor. this medical trial in of with encompasses and treatment are that the approvals. of received phase setting. will we to which need in of The to urothelial development. We following submission the checkpoint advanced CPI single-arm, the support a This supported of area and the intended and solid are This relapse previously programs as meeting. single-agent with plan trial vedotin trial who EV discuss of at primary weekend co-developing trial initiate urothelial EV October a enfortumab majority rate. confirmatory represents pivotal GU cancer pivotal pivotal study X our given the or is ASCO response endpoint strong. the of two confirmed a unmet programs have regulatory regulations metastatic Updated an study serve patients currently will

treatment, to of initiated metastatic cancer. part in second-line we as for in of trial goal combination EV metastatic urothelial with addition, cancer earlier urothelial our Xb lines pembrolizumab into EV of November, move first- phase a or In

and Genmab, response include and regimens conduct a TV TV XX,XXX half ADC the We solid factor. tisotumab Genmab co-developing other enroll detecting evaluating we Target in track is under tumor enrollment on X,XXX annually second and pivotal support combination multiple development development still tumor trial that trial Genmab. improvements regulatory for will or broad is with a confirmed intended patients preventing and cervical is in are in program. solid late-stage a diagnosed devastating will have women deaths. approximately believe we types in cancer, cancer collaboration in U.S. across We may Trials to in applications that for cervical cervical disease basket single-agent first-line types, submission and that and the to XXX metastatic with The plan is with initiate the with of X this cancer regulations. Our express FDA's tissue trial a year. TV, women Despite first is to accelerated the are endpoint this primary single-arm, approval objective rate. vedotin advanced phase which

medical As Cascadian, and ADCETRIS, of call this a proposed in from closer address bring discuss have phase needs across our and data reported dose-escalation will a activities. year EV, progress. Jonathan cancer. Darren a range X of XXXX to commercializing discuss the types. Genetics multiple acquisition been unmet of fourth aspirations And TV reminder, our development highlight that and that, trial activity end demonstrating TV developing the Seattle At has results. our Darren? to of potential to will turn over research to With I'll tumor Todd and products XXXX After financial then the point, our quarter commercial

Darren S. Cline

compared the $XX.X XXXX. Clay. third quarter versus were sales the million fourth fourth to the Thanks, in quarter XX% of X% net XXXX, of quarter and ADCETRIS up

increase XXXX. November, increase ADCETRIS cell indication. received with For these largely Sales data large XX% ADCETRIS driven sales promote in our in in anaplastic had full to assist patients. physicians its compendia in growth with been by net and FDA treatment the lymphoma sales guidelines potential growth, force them cutaneous included and fourth an and for patients, $XXX.X mycosis but of identifying XXXX, is approval was appropriate XX% previously able approval, volume. million, CDXX-expressing were particularly for fungoides, see mycosis We a the fungoides. year primary In for over

expect and contribute pcALCL sales are XXXX. with CDXX-expressing to MF progress to growth in our and We far pleased thus ADCETRIS'

territories. launch for lymphoma, extensive Hodgkin their are suggests ASH frontline in a in conducted the the team following We've prepared now setting. The that FDA following. research expanded We pending approval advanced market sales in is deployed

of potential AVD interest strong adoption FDA see plus we approval. ADCETRIS First, following in

increase Second, cures their stage most and in frontline outcomes the improve physicians patients. rate eager are advanced of to

in lymphoma to and toxicity frontline majority I the incorporate community their patients. advanced to compelling drop call physicians most to bleomycin-associated of bleomycin the discuss lung Third, a have lymphoma lastly, financial Hodgkin to ADCETRIS experienced for physicians our creates in treat case Together, results. over And their the are will physicians now turn Todd data. we Hodgkin patients particularly patients. ECHELON-X this think who receptive

Todd E. Simpson

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

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

the revenues For XX% $XXX Royalty compared year of million, quarter quarter fourth were increase XXXX, XX% revenues million, to net in increase This XXXX. compared of year the an the included the to of end end were total million. $XXX fourth a sales ADCETRIS XXXX. $XX

in were royalty compared $XX XXXX, to million XXXX. $XX end year the For million revenues

collaboration driven Takeda, and XXXX. in the $XX revenues royalties increased the a Taking a sales into program the the XXXX higher those These earned revenues polatuzumab this account, from in in milestone were reminder, ADC deals. ADCETRIS vedotin reflecting sales in were million $XXX included with by Takeda. year fourth revenues of payment triggered quarter quarter under by territory $XX a Genentech/Roche first by our royalty million its our XXXX into XXXX and Fourth rates. trial. sales and milestone million collaboration by included reaching amounts for from phase Takeda royalty one-time Collaboration X advancing in quarter a that revenues XX%, As higher

trials. our GSK, and Genentech/Roche, AbbVie with ADC late-stage our ADCs have Our technology. making progress utilizing each in Celldex, strong collaborators technology are

of pipeline. investment TV $XXX with the in In our increases receive SG&A driver in million XXXX. year and royalties commercial the for EV, expenses were the for million on entitled addition million development XXXX of to expense, in primarily or in milestones, to EV, we year. are and LV the primary were continues R&D rest ADCETRIS expenses – reflecting fourth $XXX the R&D to $XXX sales. quarter the be

initially Before of providing The shares these we on X.X our nature. fluctuations IMMU are stock purchased a X our investment which in and in the financial December non-cash for created The warrant exercised comment guidance, an purchase We million XX.X financial purchased all in shares in total, while was share million Immunomedics. to in some have warrant variability to million. additional price I shares. wanted million our IMMU common $XX in results, and of

we of XXXX, at investment end valued a the of the $XXX $XXX million, of gain As is non-cash million paid. over what

derivative to time is gain quarter of the the warrant a that security, as for fourth loss resulted This million million our consisting During gain a quarter The year-to-date it million, gain a $XX of loss third $XX $XX net $XX was of of year in of mark by included market. a remaining we the held non-cash in the offset stock. attributed million. common to non-cash

income $XX comprehensive amount benefit included non-cash For offsetting in loss. non-cash other provision tax in of of income is under million. million GAAP, tax income purposes An $XX same this financial and in included net the is a gain net reporting is presented

we included Also, be common financing recently are offering. this the and ended market forward, net which and our $XXX Cascadian acquisition shares. to with accounting gross approximately rules equity X, million fund in stock proceeds from The effect intended with of January completed common in not investments our mark Going that IMMU the stock to planned investments, does million the in include year cash We a Therapeutics. went will XXXX. were accordance on investment into $XXX for the loss and new

million. to we range of financial revenues to $XXX anticipate components increase main guidance total to a three are for to revenues. our XXXX, million $XXX There Regarding our

sales expect at an First, expectations an assumption within be in CTCL. we Canada indication our our million $XXX million. and including the the time. ADCETRIS for that to to U.S. of label $XXX not include net for does in current labels, in range ECHELON-X our reflects recent It this growth This

E-X X. date May for PDUFA is Our

decrease reflects is the their XXXX Second, from supply they agreements from license $XX in and to sold as to and expect XXXX revenues to own expected establish million. be products $XX range The we Takeda million collaboration reduction a of in chain.

milestones factors of the in by variability our guidance Our ADC achieved also partners.

to sales the of rate to year. Third, under the $XX XXXX in royalty anticipated reflecting in the sales million primarily of now we standards growth new ADCETRIS million, generally royalty year, range throughout revenues its expect to increase accounting increasing Takeda for be and throughout Takeda the pattern expect by on in royalty $XX the based by revenues the territory. We

are $XXX The in expenses Turning well SG&A operational reflects expected million expect be programs. million. ADCETRIS to reflects the pipeline last to activities count the of EV, to expenses be the our expansion of now as investment TV, year of to to to and our in range $XXX in LV head prepare needs. we $XXX expenses, This for from potential million. other million as R&D increase of $XXX support in range label, additional

While does certain that included the costs guidance, subject to our reflect are proposed transaction closing Cascadian guidance tender itself. still of offer is acquisition otherwise SG&A in and conditions not the

of to be turn as of call the that, of Lastly, the that to And XX% cost range expect percentage Jonathan. in we over XX% sales I'll sales will XXXX. with a in

Jonathan Drachman

our simultaneous important ECHELON-X. New of advance Medicine delivered bleomycin marks ABVD. without team, superior was Thanks, ASH lymphoma and Todd. England culminating an results of accomplishments regimen Hodgkin first patients at a for XXXX plenary a results the publication time of year Journal session in versus These significant for the represent that and

highlight at ADCETRIS ASH. addition than and of presentations Today, there corporate I'd investigator ECHELON-X, both including trials, more to on them. like to two XX In were

PTCL. ADCETRIS our trial five-year and survival from of CHP in data phase X plus First, frontline we presented durability

response in and of five ongoing For events. and in remarkable XX%, ECHELON-X ADCETRIS trial. five-year was survival plus CHP the cycles the lymphoma the a Bristol-Myers T-cell in remissions These is This rate with ADCETRIS trial control XX% our to Hodgkin combination estimates a continued and after XX%. reported from our achieve And The patients ongoing remission collaboration this data lymphomas under the potential PFS reinforce The four in unchanged being relapse. arm the first than the patients three-year with overall was nivolumab reported the of refractory the aggressive trial to activity rationale CHECKMATE including this for setting. trial, durable years higher data tolerability no included complete evaluating second, X objective setting percentage demonstrate regimen plus the results in These the conducted was well trial lymphoma are are of with phase XX%, we updated relapsed Squibb. operated. Hodgkin and new CHOP scientific XX of was at in XXX since

solid now vedotin, enfortumab our tumors, Clay our programs Turning programs, which our and EV as are and pipeline to late with are for stage TV. development, as summarized activities vedotin ADCs in lead well vedotin. tisotumab current ladiratuzumab

at Regarding Antonio San updated in Cancer early data from Symposium trial. December, our reported monotherapy LV, the we Breast

ADC this response pretreated metastatic in in patients. at heavily evaluating triple-negative XX% dose are We the disease. was recommended The objective rate

We continue triple-negative monotherapy cancer. to in breast evaluate LV

highlight and our part stage in planned we of trial. earlier multiple neoadjuvant myeloma assess have in In multiple will the in the setting pipeline, three In I-SPY X pembrolizumab, addition, combination today as I'll programs portfolio. that LV atezolizumab trials with our

This advance The favorable is targets on ADC and to a to in track and SGN-CDXXA testing. plan highly per more preclinical latest for a trial technology. multiple CDXX X stable antibody, a the begin therapeutic we utilizes linker drugs phase It trial index into includes soon. phase our myeloma. potency new increased First, hydrophilic X

multiple our trial BCMA, poster advancing advance in a Unum, novel clinical in enhanced year. to data meeting. session The Engineered a phase third, into on AACR trial. is we program are ADCC. receptor SEA-BCMA plan partner antibody-coupled clinical therapy a T-cell this program in our annual a a SEA-BCMA resulting together this will phase upcoming targets which be Preclinical in And X the Sugar we technology, novel with employs myeloma. Second, program X featured at expressed Antibody

initiated Breakthrough making strong large last an phase vedotin also with FDA received B-cell trial X Designation ADC using has ADCs technology, from A Therapy from PRIME Roche our notably polatuzumab are the vedotin in late collaborators year. program evaluating progress evaluating the polatuzumab EMA. both Our in diffuse anti-CDXXb Designation DLBCL lymphoma. is and This was

myeloma, an glioblastoma, anti-BCMA which In ADC addition, X is promising GlaxoSmithKline in is multiple is an phase anti-EGFR trial. a advancing has developing AbbVie which ABT-XXX, And now for finally, that turn ADC Therapy Recently, at the data With I'll early call ASH. featured Designation. PRIME and also to GSK that that, program Clay. back Designation over this Breakthrough announced received both were for

Clay B. Siegall

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

in initiating cervical of cancer trial first-line triple-negative EV of fifth, with highlights ECHELON-X pivotal with and LV For data our from enrolling including phase trial. in CPI phase the ECHELON-X trials types in of phase cancer TV trials. includes cancer FDA in and of second, Across and urothelial phase ADCETRIS, in working from trial combination this trial initiating pembrolizumab; additional phase initiating X tumors; Xb solid X additional X and monotherapy submission the and the the third, to include: trial advancing fourth, our breast X reporting combination post TV data on cancer; other pipeline patients initiating the setting; first, of the reporting pivotal EV cervical key in confirmatory

team to the key we call continuing a development. for the Q&A. the please Therapeutics will for addition offer In this line we begin for corporate tucatinib the milestones, intend momentum open to and Cascadian will commence closing, integrating questions. Upon tender of we these point, open week. Operator, At this

Operator

you. we'll go Adnan with Thank Guggenheim Butt And to Securities.

Adnan Butt

the taking for Thanks Hi. question.

by the first-line you guidance in you guidance patient occurs? would And guidance, to down approval what's once update break be Solid type? would included able

Clay B. Siegall

guidance. type break patient for question. the We in thanks don't Adnan, down by our

that never do. we're not prepared done have something to and We that's

go that – all, E-X it when FDA. that we penetration. we'll as far an We label through the to very actual to would to up from closely update drive approval there'll first will for with have We're FDA. As of and get there's market guidance, get something ramp patients gain of need is working process. we just want that from And be the and and we pool as what them will incidence is see through forward

we the in sometime but of so yet. update that, as guidance And will future, specific have we no on timing

Adnan Butt

on you approval, follow or assuming metrics ADCETRIS? those the how that up one, for you would refractory expect first-line change? to patients Clay, front-line And get and progress Thanks. them what relapsed expect to patients, would on to once setting

Clay B. Siegall

And answered. your this last will question, be so we questions can get other

have treat change relapsed for We Clearly, yet the on ours goal drug years. given for and what years guidance is the that's a you to not of need of years any asking number in this lessen and patient if cure and how been can will more could you're a relapsed patients. the patients we people,

our part of cycles, to data of of because which of we approval from FDA they in data cap removing then some patients cycles, And on cycles very guidance our retreat. on data we changed goal ago want to something that exciting say ADCETRIS ADCETRIS very have have haven't but a get again, to so, that treating And of have specific you're I you XX do presented we rate re-response, it, can that's of that showing and given and that the number that touching was the a years of high when XX we can the absolute ours. number and initial an had was

getting predict would I be And if going to patient the love someday see see look we if then, and this this in so, love I be I'd done And treated regimen was and of ADCETRIS that as really a to disease-free can additional that the as as needs therapy, rate can high and how being – patients future, any a with ECHELON-X nivolumab. I I to think in disease. survival/cure long-term

something But exciting. hard think I we're many as Bristol-Myers collaborators that. exciting. Squibb very is our in know, the with data really relapsed And you there of working on our setting be could that

Adnan Butt

you. Thank

Operator

you. Thank

with Barclays. comes question from Meacham Our next Geoff

Paul Choi

question Paul your Clay It's But of for Choi and is is And filling due for process everyone. tucatinib, the or Meacham. Jonathan. for you about there taking Geoff My anything this terms progress. in here Hi, all done the is in CLIMB near our you diligence as you've either over and congratulations Thank first on look trial, in the what on there? as term own and thought be accelerate that interim, decision for questions your you and in trial go with the enrollment regard would trial? next for of the or that's a you do then would to colorectal up, to there of you of advance threshold trial, the sort no-go look might that be that to stage timing coming able terms to the

Clay B. Siegall

So, for process And tucatinib. questions be tender please to on are we the thank you, going Paul, the this week. that starting note

the so, excited And we very after until proposed acquisition, are with this proposed tender period. but it still remains

as a complete that What the be done that work would is period to of is and acquisition the allowed I the to you for is could appropriate after we fashion. the answers lot our have tucatinib efforts I and really, of me attention. as it, a they really certainly on tell pushed did did Cascadian tender give team has not it complete. is done good. with We this So, the robust in and is diligence along caught appreciate really They

You And of our to want so, folks stronger? with bet. efforts the and accelerate make Cascadian would we any

the And bet specifics has years be trial. successful acquisition. on proposed right known answer of same just Colorectal a for have HERX. now that, completion it's of we'll for looking that You many carcinoma been we'd the after to until wait colorectal the away, expresses but that

number interesting. I other area agents there. that companies targeted as a well trials very there of And been from tested has that it's And HERX so, quite an have think is

small that it's help prognosis could need patients. a because you effectively know, patients colorectal But only of percentage potentially some you'll of a with cancer. tool do screening in You to as these poor

So, an that's and will acquisition. but at pending completing folks exciting we something at proposed potential upside, be looking our with Cascadian the working

Paul Choi

meeting, be medical XXXX top-line then we Okay. enough later the we it's regard data that. something this year? And potentially should to making could upcoming ECHELON-X, and fashion with early the on potential at for lined and a that Thank into a meeting see top in ASH disclosures that you assume could it

Clay B. Siegall

a don't I want strong that is Assume word. word. to use

I months think And when ahead ASH due. even and it of it is months are a is months abstracts possibility. and

plenary usually about Sure, we August. little those like to it's successful and did aren't would that a for but due talk a I till ASH for premature now. see, data? E-X really And to like So E-X, at

your questions. We for So, thanks analyst. move should the next on to

Paul Choi

Clay. Thanks,

Operator

Kennen go with We'll Capital Markets. Thank RBC MacKay on you. to

Kennen MacKay

thanks I questions. quick to one or Had Hey, Darren, fine for that's think, like the or maybe well. a you'd as Jonathan, if taking in, chime for Clay,

of this a opportunity settings? could sort mean is that new some of you just relapsed/refractory and checkpoints post-transplant on at Opdivo potential sort a couple high to relapsed requiring maybe temperature And on, potential year take it of in the year looked maintenance of for checkpoints are of long in maintenance post-transplant setting. or of your ADCETRIS Thank after then, at positive – like treatment. very sort as of relapse, there saw of out lymphoma perspective very as And Just And I end patients, of couple KEYTRUDA the ADCETRIS the the in again, the high-risk year the updates the to duration the negatives risk longer the given market refractory a ASH with size just there of in it conference. get in wanted much. as relates patients what guidance guess Hodgkin's who were first, of well prior that no

Clay B. Siegall

I'll start that. Sure.

to like in your consolidation X,XXX patients roughly. something So setting the post-transplant, question, that's X,XXX answer to

in really that we're the the give was so, benefit patients those there. from ALCANZA's our is trial. guidelines to to That And excited

Jonathan Drachman

AETHERA.

Clay B. Siegall

That's Jonathan. was Thanks, trial. That AETHERA while trial, ago. right, a sorry. AETHERA

working large checkpoints the patients lymphoma. as far patients As Jonathan? option. here, are really the it's cell here to patients including a Hodgkin with for have a lymphoma patient-friendly nice used with certainly and lymphoma, more and good cutaneous another checkpoints widely checkpoints and anaplastic have some alternative to Hodgkin with But T-cell We're where ADCETRIS company helped doctors is broadly lymphoma and by treat here.

Jonathan Drachman

Yeah.

in is a And drugs nivolumab first have really alone ADCETRIS trial one, in XXX CHECKMATE in rate by those an really salvage the the patients plus setting because versus Kennen, kind see – important relapsed/refractory what we're compares rate of seeing having to we improvement patients, a two point, for high that where to it think want the we using very CR I setting. if big can the and in like the response we're combining like ADCETRIS salvage.

Kennen MacKay

very much Thanks, And inventory taking it. then. question. was should question quick Jonathan. tuned just my Todd, And We'll we real thank there Got QX for housekeeping in modeling? be a you for stay any

Todd E. Simpson

got drug at routinely It's see question. say, much a sites supply We've don't widely, day. a and we of and we and just of inventory next see very just that the the is patients. don't good that. is of a help larger sites. the at not do build-up But amount is mean, Yeah. traditionally a efficient that chain I end have we typically This of a of year inventory seen delivered would will What the significant obviously, I accumulation. lot some manage to ordered

Kennen MacKay

you. Thank

Operator

you. Thank

Richter with Sachs. comes Goldman from Salveen next Our question

Salveen Richter

question. regard Thanks price my volume versus XXXX, are growth? to With you for the ADCETRIS for net taking growth guidance for assuming what sales

Clay B. Siegall

will see What what been question. price both Thanks and seeing. for we growth growth volume that's and we've is the

comment we feel in XXXX. in day, and time. amount sell know comment looking some As have sales price that's we're increases a have But that we per of forward we increasing you of that on here. our higher no really important taken We ahead that price vials generated. number results that on never we historically certainly of what's And increases,

we say be because that, it to will FDA X. And again, do very had date and anything PDUFA another progress for in submitted year we said filed year in for XXXX please E-X as out healthy keep is have mind we for not this, premature been there and put increases did and year. of going have put it we've what a – increase. So in with May And but guidance with that's to I'll to healthy Todd

Salveen Richter

Okay. Thanks.

Todd E. Simpson

the our volume-driven. was projected a the increase that be the lion's though, add X, growth is volume. going would, January share vast to majority I is price Salveen of of but There increase

Salveen Richter

Novartis-partnered multiple this BCMA? how then, new your And Thank drug ADC the myeloma to regard differ with does that pipeline, from SEA-BCMA you.

Clay B. Siegall

Okay.

the and it is conjugate. an SEA CDXXA. different. to The all, of antibody a our drug to Sugar little Engineered not over antibody myeloma drug first The Jonathan. this So, CDXXA to an conjugate, is and that's drugs are I'll turn a technology. start targeted is BCMA SEA It or Antibody

a that molecule. different So is

that you answers that? think to your to I So want anything is Jonathan, add there question.

Jonathan Drachman

about approaches myeloma. excited we're up come think that what I'm multiple I for taking different is to that No,

ADC approach. have the We

antibody We using have also we're exciting approach. a And in an then, enhanced T-cell really ADCC engineered BCMA. an target to

we're something Was the So field. about? you'd there that of sort asked covering else

Clay B. Siegall

No.

Jonathan Drachman

All right.

Okay.

Salveen Richter

was Thank That it. you.

Jonathan Drachman

Okay.

Operator

with Our question Michael Leerink. comes Schmidt from next

Michael Schmidt

phase patient the question. from follow-up. planned. thanks this study? is phase I is, taking X accelerated identical my or had guess question target X I that's guys, population I trial vedotin then the And Hey, had regarding trial different a Thanks. And approval one enfortumab the the for for

Clay B. Siegall

ahead. Go

Jonathan Drachman

the inhibitor setting. same in post-checkpoint It's It's population. in the

Michael Schmidt

what the those And patients? would arm in be Understood. control

Jonathan Drachman

what to That this We forthcoming. is be that haven't exactly at spoken point. will

Michael Schmidt

Okay.

Clay B. Siegall

Yeah.

be get and the will that's as initiating, study with clear more our we trials. history to We closer been on

Michael Schmidt

there's physician remind Understood. And frontline or whether in And are in patients whether pending one notion managed a ramp at setting a this some or on Hodgkin demand pent-up frontline you approval what the on community Hodgkin point? can in I obviously versus guess, of of ADCETRIS. approval the the academic, community-based of expect frontline the currently whether us and launch, – percentage would pending just gradual actually question community treatment pending

Clay B. Siegall

right. All

can I think Darren this. answer

Darren S. Cline

Michael. Hi, Yeah.

are novo. majority these diagnosed academic, de versus patients community Regarding of

AVD community. ADCETRIS given in of and diagnosed more than diagnosed of can the half the that community. and they're the in about are the a majority patients you be the easily lymphoma, than Hodgkin X,XXX roughly recall, be number will and We available community so – in more So advanced, of are half they little those think plus that's regimen patients if is very about three-quarters diagnosed newly that

pent-up demand, again of diagnosed, so reflective identified of these of kind patients month Regarding patients on if ramp patients you will that there and placed certain are and will, I be will be – amount that that diagnosed treatment. a newly think each are

Michael Schmidt

very you Thank much. Understood.

Operator

Andrew with Stanley. Morgan We'll Berens go to you. Thank

Andrew Scott Berens

taking my for questions. Thanks

know revenue not Just potentially had are impact revenues one more E-X upstream or guys But to guidance. from are from on adding expansion? the usage a you you including the impact you I in label assuming are guidance, not E-X any downstream

Clay B. Siegall

not positive decrease – the in That's not we what we of for in decrease not as to would you're at the We're what that guidance relapsed/refractory have the on that E-X suggesting, point. is going future. for projections, the not at put projections is not that's we're something – putting The this doing. really use guidance side, not and but projections this upside this put into point and we're in

Andrew Scott Berens

that. that, update? you that Okay. growth give us opportunity? talked for Thanks just setting. in currently used the clarifying an in penetration about be And then I What's for that how and past there could in being number know much of that there can AETHERA, you've the are cycles approximate

Clay B. Siegall

with color market to add? Darren, and are on penetration working getting so you do in clearly and used to been it that. have the more in positive any you we've increasing consolidation want been setting. Doctors we've Yeah, the more

Darren S. Cline

of Yeah. I XX% we're penetration. mean, north

XX X for we setting cycles. unfortunate those And frontline in to in hope the Our see to number patients decrease is of have setting. We the average the relapsed duration patients. that continued E-X, utilization with

Andrew Scott Berens

guys. questions, I appreciate the for Thanks it. Okay.

Operator

Tazeen Thank America. Bank with you. Ahmad We'll of go to

Tazeen Ahmad

regards for taking in from you questions. Does force the on thanks sales for an have my what year. anticipation uptick SG&A for be of guidance that label with the to expansion you'd that noticing E-X? year, extra your this One assume commercial, on adding Hi,

Todd E. Simpson

Yeah. I'll Thanks, that. Tazeen. take This is Todd,

added, have Darren folks the field. and, deployed into now increased trained been field actually our So have as they're we they've mentioned, team already. been Those

wouldn't our our we've that. and offer I quarter covers not also predominantly in close, So do were there until SG&A that is – But costs ongoing certainly acquisition as some the into included I the related that think some expenses, in transaction of to tender the the guidance. have expenses that increase first the were earlier, completed built the we transaction incurred mentioned we but Cascadian operating

Andrew Scott Berens

May get do you fully that adds can new in just your assuming the force trained and many approval you've anticipation? X, on us on sales made to force you And Okay. your sales if remind is how

Clay B. Siegall

do want go... Darren, you to

Darren S. Cline

team roughly increased United our in Tazeen. in representatives added Hi, well. also so third, Yeah. the market it a States. roughly We've – managed as by We've sales presence increased XX our

deployed opportunity on fully we're execute So to ECHELON-X. the of

Andrew Scott Berens

of doctors be commercial, intent is the there the group experience those question can on targeting that would physicians on that for you the obviously a added identify? refractory/relapsed had targeting, be lot last same you've a might been ADCETRIS that not that using or then in And would you you have an setting,

Jonathan Drachman

Yeah.

community the think the not number the setting. as think setting the there used discussed, the patients, it the larger about, – I we when relapsed initial number have will that you be diagnosis or consolidation physicians in in and of addressable

broader this So was of was opportunity sales the increasing the again addressing patients are these our calculus force that diagnosed. and majority of part within which community,

Andrew Scott Berens

much. Thanks very Okay.

Operator

go with JPMorgan. Kasimov We'll you. Thank to Cory

Unknown Speaker

(XX:XX) kind Cory. guys you thanks Do on Sean the and now? relapsed cancer? potential then about there just in on my setting the talk what for bit Can have the setting the is just perhaps quick some taking now is of a for you just TV out this Congrats of the other guys, opportunity Hey, this of question. in follow-up. right quarter sense are right options versus incidence frame more in and a cervical the maybe I for us And have a guys that

Clay B. Siegall

will start Jonathan can color to add and some maybe I that. then that Sure.

a benefit therapy interesting is the a So market we think for very market patients. that that really cervical can cancer

Just cancer. and And in GARDASIL despite having and due is X,XXX is early, diagnose to way deaths this the could there's this diagnosis you U.S., cervical vaccines. the XX,XXX despite

diagnosis enormous there's it's problem. U.S., vaccine. is that incidence the an gone around pretty this There GARDASIL, the where and look and XXX,XXX You everybody worldwide, of I In down the year are countries because but where a uses because it out read hefty, it's not globe. still big, pretty many has

of prognosis treat. The is we it metastatic cancer really something think important is cervical a And to so, disease is horrible. that

that low. out used the are that very XX% the rates response of there are to some X% And drugs have in range,

excited think color... upside. good and of this So with we a patients really got with we're helping the chance Jonathan, any it's

Jonathan Drachman

is the I'd that what cervical out relapsed/refractory there's cancer add setting, Yeah. I in nothing good guess there.

and care real patients, we mentioned broadly then, solid frontline tumors important where that vedotin at so we other it for and which setting relapsed/refractory with of areas setting, at of beyond tisotumab whole into as there's see agents including can the offers And opportunity. expressed outcomes tissue trial earlier, on And looking patients express And data presented standard we think opportunity the TV physicians. Genmab improve this factor. other a two be and to previously a solid frontline bigger that objective tumors. express exploring factor in looking basket in with solid obviously going tissue And combinations we first if we're is tumors. a responses would group in then many And a has were

like registrational the we near-term and like we So, This target the opportunity. is first opportunity. the

Unknown Speaker

for ex-U.S. give And your pathway there? Perfect. and you regular but up that trade a Okay. understanding Takeda, can broad course, this the is, quick then, expectations real of outline to us with just the

Clay B. Siegall

you mean... regulatory, For

Unknown Speaker

that be sorry. lymphoma would for Hodgkin's frontline, Sorry,

Clay B. Siegall

thought you I to E-X. probably were Yeah. referring

happen can tell would to I that can they best you what it anything for at think get providing Takeda's for us label appropriate be hard and to is in helping I making not But outline this patients. work specific the they're related territories.

Unknown Speaker

guys. Thanks, great. Okay,

Operator

comes Mara question next Our from Fitzgerald. Cantor Goldstein with

Alina Levchuk

Mara. is just the for had about This Hi. We the expansion in for CTCL. you taking label Alina Thank Levchuk quick in a question question.

expect the in you and market? the market for MF fit you what in ADCETRIS can discuss So, and of terms maybe ALCL potential

Clay B. Siegall

got right. the question make me I Let just sure

you about that? want do in about extension CTCL? a label Darren, bit You Okay. little are to the asking talk

Darren S. Cline

Sure. Yeah.

with about CTCL, fourth which those roughly fungoides low to and we it label. of ADCETRIS relates to mycosis As patients our a there those was two to of the in fungoides, CDXX-expressing subset are the fairly subtypes. label in the for alluded majority are X,XXX vast script, the as prior mycosis pcALCL Awareness

to that is approval, see opportunity there are offer our this in now feedback the data that out from patients. And excited representatives so, their The a were fantastic. was to promoting. we setting sales physicians nice to prior they And

us a term. see particularly So, the we look nice XXXX we to opportunity near for and as and

Alina Levchuk

Great. EV the then bit the in enrollment urothelial as any one the cancer, pembro study look provide progression? and maybe enrollment what And more, you. study additional may, I about little discuss like to color the for you can Thank rates a if and

Clay B. Siegall

in Well, what started October November, in the the I EV single-agent any can tell comments started we made you the we and haven't is about we're we on, have is of Then really that working that. pivotal trials good specific EV good. trial two the to-date XXXX pembro – enrollment and trial

and have And to But the doctors it, don't speak is that and drug comments on want make and that where so, liking out turn enrollment to getting I made are EV really comments could you we strong. used of is in there. I this tell

Alina Levchuk

Okay. That you. sounds great. Thank

Operator

Peaker Cowen. Boris with

ahead. Your open. Please go line is

Boris Peaker

just sense Great. I get of ADCETRIS. Hodgkin's marketing squeezing Thanks me a message lymphoma in to specifically for wanted frontline for your in.

cycles give Just lot curious bleomycin to their only be in will patients? a two what that you of of today marketing docs kind of

Clay B. Siegall

you Darren, to... want

Darren S. Cline

Yeah.

Clay B. Siegall

could clues exactly what know say, little we we but give you I of I can bit don't a mean, here.

Darren S. Cline

Yeah.

Clay B. Siegall

have here. label don't We yet, want far to don't so go we too

Darren S. Cline

very are able around done at All excited the day. I the lot offer bleomycin is physicians and them and with research be haunt of patients the we've stories look that can have market this they to them physicians this say with is, having had A regimen. to data, to

But young that's have response rate around a bleomycin with be a And this this of there's execute able in population. get that to data, the research so, and they're of offerings to absence regimen. we'll for excited AVD they ADCETRIS what excitement on the that, offering Outside patient this into plus young their once patient this population. we're in we to treatment indicates lot incorporate label, able the at of And messages. our look very our

Boris Peaker

give frontline the practice in itself? they to cycles clinical it suggest maybe research to study many saw compare how your setting the does relative And in in may what you

Darren S. Cline

trial versus I mean, in I world protocol, think less. see that Yeah. real typically typically you

curative to physicians that in in the the patients, trial. to again setting the saw think we've with they trial, they ECHELON-X a use feedback the that I in is that have get gotten in overall results intend the this regimen intent these full

Clay B. Siegall

comment Jonathan, you on one Yeah. the first have question? more

Jonathan Drachman

Yeah.

the But giving done something created bleomycin it So the is dropping what ABVD, than or something really than either regimen, dropping trial. close either non-inferiority full was that that's a good was dose create bleomycin just as early better we've ABVD. to about idea as was to

that's something goal Our to superior. was do

Boris Peaker

Great. for questions. much Thank my you very taking

Operator

comes Yatin with Suneja Our next SunTrust. question from

Yatin Suneja

physician your taking Maybe suggest Maybe Hey, feedback on just suggests guys. Boris' us little there. my more patients, you're Darren, in color a Any help think, of the Thank more – a particular strong a irrespective question. bit your more feedback you the or robust response, question, frontline mentioned seeing setting. comments, post-ASH in work for expanding where that or you there? prepared are maybe give similar us some give subset disease getting stage patient you color of the age of the I

Clay B. Siegall

is what assessment at What and what looking out that's is. lymphoma. that's there, our advanced are we are market And we Hodgkin

talking advanced we're the about So patients.

it's be not advanced other. patients, really or patients, just the one be that can can Now old patients young

community So largely the it's that advanced patients are diagnosed setting. in

but toxicities people. Bleomycin say, there, has. young it it is like on a use they out there can that we're we'll only long-term people, old this, not one not toxicities And on lot it's use well, trial in a has short-term so of that bleo quantify that and only

to either. and or brittle look the patients, toxicities if young want it want more if they of of they're they're frail you short don't So, toxicities certainly have bleo. And than people, older – the look and they at the don't you long-term patients, the at younger more

that eliminate will this looking to we survival, decades losing disease got bleomycin. activity. do have without to But a a less it's docs as The docs decided line less like talk lot to at activity, certainly equates want less for long-term but they rate of few and bleomycin you get when way of disease-free of a use in lot you it is, you a which got toxic, having So, you use it's to bleomycin. it, less not able cure, regimen, one often bottom And And without we this. from look less a been not get any population higher a you bleomycin. activity now, to for and and been

the that think highest bleomycin, start long-term lymphoma to regimen I chance looking get of our so when advanced a Hodgkin And at ADCETRIS/AVD without gives what so and disease-free them patients, excited we're you survival that's about. having

Yatin Suneja

on data you're that you helpful. Very going question what on update Todd, patient, week? week, tell this could the royalty quick a comment us just it. should we sort later for we one there, an presenting I then your think what of be Maybe many expecting missed later be And anticipate how Got maybe EV should Todd. this to I another just the revenues.

be that is in to annual year you think an this reset, so a guys going QX, have are royalties Thanks. I case as weak bit the the well?

Clay B. Siegall

Todd, you to first? want do go

Todd E. Simpson

Sure.

evolved So the this $XX record with of some used sort general. in be to the of royalty of guidance one occur is have little gave million we'll royalties arrears, change bit we ways $XX around going given as million to royalties now in to accounting recording We rules Takeda. revenues they that a the quarter year

we those be report So Takeda sales royalties QX. would now quarter in be recorded royalties QX fourth will be in a to QX of pattern reporting what sales, used

that year. a grow also, to expect rates would royalty where But January mentioned, is we then now every then climb throughout what see reset Takeda. So tie you as to pattern and they would throughout the by year, royalties the X sales growth the

So half of the year first in the royalty than half higher in rate the the of year. actually the second of is

Clay B. Siegall

tell EV, to will we're talking the Going put about not from is we exact question already that numbers. are on updated your I we conference, – you patient the this until data that data not But out.

very data and that data more just mature of exciting. the a it's was an for that we expansion data out put So

is out In of combination the already in fact brought excitement pivotal starting of this in single with us trial what the with trial. we expansion checkpoints as agent put to EV of using and excitement separate data a and data the a the

Yatin Suneja

it. Got much. you very Thank

Operator

Blair. We'll to William Hsieh go with Andy

Andy Tsan-Yu Hsieh

thanks taking my for Hi, question.

kind on sort higher presented the of Just critical Engineered that evidence far activity? have any that could one of some might remind you Antibodies, validates clinical Sugar us so data this

Clay B. Siegall

to address Yeah. that? Jonathan, do want you

Jonathan Drachman

our SEA-CDXX molecule, it's cross enhance bit of little that, when there. ADCC, a action. SEA-BCMA We clinic, only little ability Yeah. an Antibody it have that enhanced about but by antibody. antibodies complicated And data data preclinical does the talk later linking because also not we be With presented the monoclonal not the mechanism We when fucose with the it presented incorporation it clinical not to CDXX And more signaling this into is more data, data lot presenting causing that anticipate enhances presented we've clinical on And strictly on going by year. of binds. of the into we will that. bit create a principle blocking ADCC a

Andy Tsan-Yu Hsieh

Thank you. Great.

Operator

Peggy turn will to or back with no questions, remarks. any over additional And additional floor I Pinkston the closing for

Peggy Pinkston

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

Operator

gentlemen, for and conference. all, that again, again today's you, Thank ladies does you. Thank conclude And participation. your

now may disconnect. You

Seagen (SGEN) 6 Feb 182017 Q4 Earnings call transcript