EXEL - Earnings call transcript Q2 2021

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Operator

Good day, ladies and gentlemen, and welcome to Exelixis Second Quarter 2021 Financial Results Conference Call. My name is Franzie and I will be your operator for today.

As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. proceed. Please,

Susan Hubbard

and quarter for call. XXXX Franzie, the us you second Exelixis financial thank you, joining all for Thank results conference

and me is our Chief XX, our our are join CEO; call the President ended of will Haley, on June our will Vice also the Joining and together Chief question-and-answer second who President XXXX review our Mike Executive Lamb Chris for for Officer; Scientific XXXX. following Financial Morrissey, our here Peter Commercial, Officer and progress P.J. us Senner, session today's remarks. quarter prepared

call to measures release, of from measures, for using according Please calculated we these website, is the as During Accounting to our reasons well refer today our will explanation which financial measures Principles. an non-GAAP Accepted deriving Generally refer our such posted not tables press results. as today's GAAP on to for

results in will events the development commercialization I heading, forward-looking level includes writing of regulatory dependence on product or conducting commercial product activities. without the processes, presentation, making developments our regarding differ And strategic the commercial, important statements course development, of from partners product that cost review the performance development, events over including time materially be verbally we will future those today, applicable Mike. could the to trials, approval results and risks materially. by discovery, call clinical regulatory, to future and turn actual the competition, we course, discovery, related that regulatory and expressed to and limitation, under with market from of requirements, to identify the Actual matters. success, compliance documents to with, We uncertainties refer associated with file company which and financial business SEC, regarding collaboration company. with about Risk the possible and time differ this Factors, of the you statements could, cause During This and factors

Mike Morrissey

XER pipeline call Thank the and net in had a quality of Susan, strong from of first-line on everyone first-line and plays quarter strength Syndicated market highlights cabo/nivo CheckMate to net the data second combination year-over-year CABOMETYX the of the today. Exelixis’ the and revenue RCC grew promising reflects maintained us on CABOMETYX research with momentum XXXX of quarter market. of XXXX. The We as in leading to QX, XX% significant in cabozantinib revenue life the strong same segments that trial. product in a our franchise right. All and tolerability a of across we RCC all efficacy, growth the company and the you, early-stage role product the Cabo compared all thanks franchise total our demand period business, for joining record based doublet second posted advance for programs. in nivolumab the revenue segments across

quarter. COSMIC trials combinations full review with December and for of XXXX. X, to plan. move ICI late-stage cabozantinib of portfolio continues priority to We annualized the Exelixis second DTC, in Our indications, new remains RCC along discovery, regulatory pending to $X.X with a US. for in with positive submission key in these the development exit COSMIC-XXX COSMIC-XXX details plan and metastatic activities of results doublet for which cabo/atezo in file COSMIC-XXX on was accepted regulatory to feedback, top from trials in update sNDAs CRPC line reported first-line regulatory We for upcoming Cabo for with date for And HCC X. the in and XXXX CONTACT forward run billion PDUFA also goal presentations the in two feedback cohort rate advanced XXXX from you course. the due The these according we'll and

Phase XLXXX significant with characterize for continue advancing candidates foundation program optimize the with the future. the initiation Exelixis trial XBXXX The candidates believe in preclinical X our teams is pipeline clinical for to enter and biologic clinical early clinic. first in we XLXXX and provide to and Our work both new of new progress the ADC small discovery clinical will near the development programs, molecule which the and

market. derive Finally, more by number quarterly with estimate on and of patients a the get we view success that approval that from develop are ultimately patients treated XX,XXX we global than basis. that the drugs benefit discover, currently cabozantinib to We

an and have and impact Cabo preclinical cancer, to our emerging ago with that, financial guidance. an indications full pipeline on existing drug release the full-year evaluation. of press With an proud update and the with greater financial across issued review Chris, please and of an key we're quarter. accomplishments new detailing list turn results provide single to people quarter achieved who candidates our highlights XXXX at corporate While magnitude extensive our quarter excel XXXX results day now we hour call financial see second strive their of to every will to for this even our clinical in second over our level in I'll

Chris Senner

Mike. Thanks,

expense full-year of second second For also revenues Takeda of inventory for inventory the million. XXXX. share quarter reported change second quarter in Total stable of demand compared net decrease of to of related reported XXXX. The XXXX. in company and million diluted on primary $XXX.X or The a the And approximately of impact operating for income million first Genentech second for June turning were XXXX R&D XXXX billion. product second to expect million year. for trial were income for product million for XXXX in our quarter wholesaler XXXX $XXX.X driver total lower provided of $XX.X total $X.XX line earlier of range $X.X the in of from hand. primarily of reported per diluted revenues company the a share $X.X the expenses. was in cabozantinib income effect. $XXX.X for We're $XX.X of the revenues XXXX taxes Provision product in fully increased the expenses approximately operating finally, $XXX.X and CABOMETYX. on and net net quarter per investments the XX excludes the was expenses $XXX.X Non-GAAP total Our of was cash to CABOMETYX million $X.XX increasing or company we net GAAP quarter demand Ipsen, the quarter compared income are related non-GAAP R&D year-end expense Cash total weeks quarter the $XX.X net which first financial $X.X quarter We the clinical financial the to licensing for stock-based billion Total of billion expenses, this million our million included and were the higher for of benefit Net to due milestone revenues and $X.X the collaboration a franchise updating guidance revenues. net included and ended in $XXX.X XXXX, in million impacted tax resulted with by million. revenue the on the reimbursement basis. of guidance, total be in compensation of now also quarter which revenues guidance fully revenues basis product revenues the to higher for revenues income net R&D

are billion billion million product to licensing now of and which for range projecting are I'll key are guidance, increasing the we and finally, And development expenses guidance potential be and activities, be business And of billion. million. to stock-based with year-end new $XXX the the million, at related forecasted range compensation of expenses due to a which does the in now includes our expenses higher $XX include Research company. increasing and approximately which $X.X to of priority the billion not revenue development We net $X.XX to expected we in cash impact to of This expect are $XXX call P.J. primarily be $X.XX over remains the and in non-cash that, turn range XXXX. and investments any $X.X

P.J. Haley

with regards Thank will context an CABOMETYX first you, combination with particularly the the quarter CABOMETYX QX in checkpoint in immune approval I after XXXX the the of Today full to of inhibitor. Chris. business discuss

you on FDA first-line for XX, combination with in approval nivolumab. CABOMETYX know, January in RCC As received use

driven marketplace. CABOMETYX the TKI the was first-line the grown approval significantly uptake RCC. Following broad CABOMETYX prescribed in market the quarter in second by one number In has share

are of pleased first-line steadily combination brand has impact, approval. with patient IQVIA to the according growth CABOMETYX the grown which We new market since share,

taken As share combinations to therapy average from with penetration XX%. you has the ICI combination CABOMETYX the of new market. RCC can see, patient share combination in market other was nivolumab increased QX the combination ICI within CABOMETYX first-line data, the has and the of in According

years. study of therapy for patients know, the the approximately duration you was CheckMate X.X As median XER in

come. to that many will believe drive starts we for these So growth quarters demand patient new

intermediate community according continue share in was Adoption combination uptake pleased resonating in that risk share favorable QX new they we also broadly across with Impact. key in with grow are That to segments are think is from about We a as in in Uptake patient in the segment. appropriate increase that number data has and share to lags as poor was the adoption in a as groups community believe to to the broad strong combination segment physicians research Brand QX pleased in setting the market with clinical segment the particularly patients of the market for XER CABOMETYX XX% launch. XX% taking the market competitors. nivo our who this in academic setting regimen. by the in been academic shows opportunity in first-line the XX% nivolumab, with and QX community said, are that from has Furthermore, share typically the rapid all we market for is in CABOMETYX,

perceptions rate rapid In of well of IMDC impressions of nivolumab the on very been as of combination overall progression-free the across data approval as in positive. favorable of survival, addition the of CABOMETYX XER and survival, the response increase based subgroups of including in this combination broad There risk the endpoints efficacy objective has plus a categories. key the uptake marketplace, been have unaided the to awareness

by Cabo totality in and Importantly, by important dose the for of safety their prescribers and time. of viewed the is survival, an life positively on data seen CABOMETYX by and Ultimately, tolerability quality XER patients Physicians life safety of in the growth of the refill balance XX% differentiating of increase is first favorably efficacy by prescriptions of milligrams is relative the of profile overall data demonstrated of XX prescription growth of tolerability and demonstrated is driven lengths of new the from The are perceptions extended of the launch driven is first from optimized both improving safety, point starting may in which benefit who also inflection and combination overall daily and CABOMETYX. this to the year the viewed and prescribers. XXXX. Similar for therapy the demand. in half IQVIA first-line combination trends an view and the half XER resulted the XXXX be in quality and

success for changing overall increases we in data these data mentioned prescriptions, regards to for patient the half won't were shows of of said, the for CABOMETYX being down competitive the to I internal is the patients combination XXXX nivolumab RCC. in XXXX, the line being uptake, CABOMETYX first reasons. relative at X%. but CISV-NRx to first in despite stable. be market remains As With XX%. and larger increased of time comparisons, of second with period starts sharing the combination our previously, market of XXXX driven by The on rate CABOMETYX the half stable to That is first-line CABOMETYX basket QX growth while launch NRx both mix specifics the share new that of QX NRx for new significantly and relative a

First-line are combination of usage prescriptions has increased Cabo the new the first-line. proportion that

to data study, for for years CheckMate driving we therapy more or CABOMETYX. patients these thus Given anticipate the first-line a the longer approximately clinical X.X from the combination duration XER treatment receive

disease is The for the that by X% putting amount robust. QX The significant the nivolumab near the third has either decreased was our RCC histology. same combination July, further by encouraged the forth third-line and We're that execution QX regardless launch groups, third-line and in many XER and TKIs, other Exelixis. in TRx/CISV cancer in CABOMETYX share first-line will and CABOMETYX kidney by in by updated share one increased RCC have market agent first-line with share and now, at of more XXXX NCCN period QX is in thrilled to period. that are indication RCC broadly. beyond. in a market new fact of performance or TKI of point market team opportunity prescribed as the This volume provides increase The grew preferred patients of the XER in strong received in to looking the and guidelines combination as QX was the increased monotherapy already CABOMETYX the XX%. basket in We XX% our CABOMETYX position And In the patients trajectory, CABOMETYX at is of data, number uptake driven dose patient starts line is time their setting in This or in Exelixis therapy, the a declined TRx every support relative in same and that franchise that CABOMETYX. year. combination doubling strong in the with last in the the TRx over in to launch setting. volume the market cabozantinib risk proportion continue cabozantinib of revenue growth focused XX-milligram note One as to we setting clinical see in line volume uptake the CABOMETYX

Looking in where foundation number RCC the continue to one build the TKI. upon is prescribed forward, as we CABOMETYX

CABOMETYX motivated Mike. focused over team of maximize the bring turn the build And compete patients to and to day back to we potential. highly to and call I'll to every franchise Our the all as remains that, with continue eligible benefit

Mike Morrissey

All right. Thanks, P.J.

work our live we mission the growing to revenue XLXXX as components on of heard cabozantinib We're patients we led and our for pivotal help the product of us development great full a second clinical recover total about today, our advance and longer. the rapidly with to potential ongoing the net you quarter both guidance. year including update which early-stage our cabozantinib XXXX record call trials, stronger program cancer revenue and As excited franchise pipeline, in had maturing

medical during Chief her previously in Gisela Officer grateful absence and President that announced, us engage Product We're June. continues began Dr. our leave and we Medical Development to and a As Schwab, of Medical Affairs advise of leads. she

drug without than committed entire professional be cabozantinibe has mission together Exelixis of proud XX her tireless serve. patients more company, passionate development We her commitment For Frankly, would for to simply years to keep mentorship enough can't we and mini years, the all has that nor development thank the the her team. deeply our leadership. track organization countless the been they pulled would today further to her Gisela programs the our not Gisela and contributions We're over including of extremely and during even how the on her absence. are

with on energy experienced to creativity the date. and next that and to of our to foundation, We support that Thank happy in need Exelixis. widely quarter. in patients based remotely are questions. looking proud have both and With for to working for in next by person We future. your and you Alameda for and continued working the been has again team we supporting better are I'll collective for medicines team only productive than side now that data progress in board call therapies. XX% to efficacy I'm working you in future. look Exelixis vaccinated for of the efforts a near by effective our embraced open as second forward during vaccines forward COVID-XX the our and CMO to We're truly now the the thanking side the close and that be updating individual safety more and have hope the actively the are Exelixis we entire cancer in their interest and busy report our we and can of generation searching on commercialize of those develop discover together

Operator

Instructions] [Operator Goonewardene Truist. you. Thank question Your line the of Asthika from first comes from

Your line is now open.

Asthika Goonewardene

my taking Hi, for guys. Thanks questions.

First, future. coming to in of on we congratulations well this I hope done absolutely the to want team this outstanding, my more offer the result, see to and

we good. was I amount. RCC spend first-line the really to maybe First question And teasing if have is nivo big looks rate just Cabo for a maybe want a sort Obviously, give got just RCC P.J. the wondering contributions. there's time I'm relative little I growth And that first-line here Cabo then the after. impact? stocking RCC? us nivo proportion other can non-clear if -- from a some few maybe cell of I've and Cabo guess what came you came And any from more well as out that

P.J. Haley

as the there comparisons -- uptake of demand nivo Sure, would half seen we as Ashtika. that we've have we to growth coming I I combination looking for think average really that starting that Thanks new at data P.J. the with for duration years say think pleased the first we're looking which XX% NRx clinical time. at driven It's I the certainly by strong. That's I completely sort on we're mean launch the first really they're in of quite the new they'll the for so are over half the there refills XX% last you growth patients And -- and X.X CABOMETYX prescriptions really of shows it's mentioned question. mentioned, on therapy, in for be get setting. almost some

guidelines mean favorable in cell. being NCCN I little more really sure in that. positioning it's bit anecdotally, were we a we're the days -- just really now updated we're first-line pleased intermediate So But And that. month, think nonclear getting as those now clear -- I'm last I early the poor by NCCN with mentioned guidelines driven I cell. have

line as cell. non-clear now as second have well cell We clear

in growth setting. predominantly the launch the as guidelines great, the with combination combination of think the in really either But first-line we growth and is drive certainly to across will future. the a cabozantinib in continue is monotherapy So that combination the

Asthika Goonewardene

of Nivo/Cabo you then maybe tell wondering I tell some if competition when there's about And that have tender, line as future how a -- fare look big with the us the your pretty Nivo of is if threat, the if or will that Thanks against you familiar well-protected primary research maybe given future down particularly you about Cabo? RCCD what guess if you're can think launches, you us at that look IT and P.J.

P.J. Haley

question. this Thanks prior in in certainly Certainly been competitive setting. has for years for the our Yeah. even market monotherapy but settings, first-line many combination the

share, the quality and And data, and market overall right safety as patients well team for the data, which the on in work, there. who So, in data the seeing on think today very be market data, are starting therapy well really really All XX% really and XX-milligram compete optimized all length physicians outstanding. tolerability our going that market the as approval it in important we've us is, ability it's totality strength regimen forward. from we pleased the think to with going our what is the as marketplace balance survival, particularly daily our the of we're is dose, team of efficacy from the and life, roughly the of that with, positions hear of months experience which the I well five time. research extended our the the of after seeing seen already the our as and and coming are time for well by and And to to pleased and certainly And the our the really the we're establishing data. speaks in of clinicians right what we first-line execution

continuing So lot forward our to team position, we're grow look and a more and with execution our really patients confident RCC. and our helping to in

Asthika Goonewardene

of if is Gisela, bit sneak one channel really about Thanks if to inner presence Mike things this talk we you a Gisela’s can her. quick expect on near-term? can your are I and for with here. definitely XLXXX then well hope maybe missed you could that P.J. terms can And in one in the what us call, in little data

Mike Morrissey

consistent that. prior to I new think I'll has messaging. I my that at Nothing inner channel I'm is report it messaging very because don't regard here, well. Yes, XXX as to in Mike, today can do really Gisela with our been do happy

the of kind we've it very there We got with molecule, has and exciting are clinical next-gen commercial high the a cabo XXX. opportunity excited profile the this really priority think We a that and organization. with about within profile of is very obviously

validation We with to leading combinations to with profile BMS, and approach. Genentech are now overall our the ICIs underscore collaborations I able pleased with collaborations ICI and clinical think the Merck the potential now for three be have certainly Roche, interest, to KG XXX utility

pleased certainly with So we're very that.

priority for work program if on planning to to has today as the the move make months been is clinical trials as expedite now Our the enhance and year, months can plan. really that XXX as soon pivotal possible this we as in it and that's

the we'll now data. next So there's guidance guidance those you. details, of presentation those we really no new with previous or Obviously share have on when

either et to set. likely start collaborations, You're see before new data you see cetera trials, new us combinations, new that next

Asthika Goonewardene

Great. the and again update. Thanks guys, congrats on

Susan Hubbard

Thank you, Asthika.

Operator

comes King the line question of from next Mike from Wainright. Your H.C.

Your line is now open.

Mike King

therapy quarter the Nivo. afternoon, well-being you Good just out Cabo a of on think great let expect to well. interesting on can convey talk project just sentiments be duration for I I willing my would average question. and for Gisela Congrats towards -- P.J., very that about taking Thanks what guys. it's as you're the we me wonder Hi.

as single on for agent is now. you a what in the line know Just reference average to cabo second standard, happen do time the a

P.J. Haley

I'm talking about This just to XER. take clinical in what P.J. really Yes, the to saw trial is with Happy referring mean projecting data, Mike. we I about the in to questions. the regards

seven, see really -- we of commercial we seen regards cabo's rather the do is X.X and certainly as can in patients, that's patients see are have years, before And remain we've single What more saw what seen in pleased on duration for In who data. marketplace. on months METEOR the a approximate So, and patients therapy. anchored the certainly can setting, it we've certainly which with it obviously many had what with, in There before generally. the at we've benefit. of -- those of or some we retrospectively agent trial that we're in the longer, lot saw less to you we therapy PFS retroactively terms terms of look to to

So, good use forward. and pretty so a obviously track far we'll the surrogate seen we've is, trial going what to something it's closely

Mike King

Right.

comment the that. these de whether appreciate individuals or NRXs, of immune on on you combination an novo? already, if can are who starting I already Also they're about are nivo or you on Okay, do the sort know checkpoint

P.J. Haley

I'll Well, today. pieces to point data I two of maybe different guess, in our presentation sort of

the So, are new just CABOMETYX NRxs any from prescription IQVIA.

be data in setting at of could with looking nivolumab, setting that combination really in would the utilization into was line point I the first What any dig line of therapy et CABOMETYX So cetera. to and to XX% IQVIA combination regard up taking from to all a now which shared we've market get new share, with space. in competitors patient other the in share to with seen increase steady QX we the

establishing market pretty really strong quickly. a share So,

usage de according really the brand that's of data. impact novo combination to the sort So

Mike King

Can then, just XER? us Thank you filing this. CheckMate And other in for remind based -- is Europe quick just Okay. what the you. one should on I one know of status the

Mike Morrissey

good question. That's a

And don't I think not normally That's a Gisela speak one want to they've she's been would that. to that -- here. good I answer.

we'll back Mike So, you. get to

P.J. Haley

Yes.

as it's know you workout partners with there. securing quite jump on Ipsen a obviously and the is in Europe we And focus. say I'll diligently Sorry, closely in our countries, working and which they're just reimbursement and work across the approved various that

there, they're very So pleased certainly -- making in the there think early we we're over -- the but launch of days with it's got. progress they're what I and sort

Mike King

to much. come. again. More Thanks Okay. so Congrats

Susan Hubbard

Okay. Thank you, Mike.

Operator

of of Your Bank Gerberry next line question comes from from Jason the America.

Jason Gerberry

my Thank for Good question. guys. you Hey, taking evening.

the guess rate RCC believe run just think end comments I I so, $X.X So, of -- year-end for, a that's billion XXXX about I revenues.

quarter. X.XX Just would through $X.X a to quarter the the flip end per run might of guidance that like I think the renal million like for year, you did billion and with be you $XXX fourth trying rate cells of sort like

growing stacking, share. patient So, market it seems you're like with

Just with wondering just considering for some be the another TKI you of market wondering year Just will baked conceptualizing competitor another run in conservatism space? how guidance the are billion is presumably the a possibility there guys into XXXX, I/O the $X.X in rate kind of in there kind of Merck?

Mike Morrissey

something relative focused obviously to on think a that's we're the competitive here. and dynamics that Well, about lot

started we launched. been I think That's day P.J. RCC media got trial, we framed since the the the case approved, we the and with it and day day well. the

So nothing that's here. new

I that $X.X think market rate with, research XXXX. and for kind was duration that the run there therapy. of on the the end the view launched a well billion out by market put I ago ramp level and appropriate we guidance quarters of think, Again several estimate, before guiding of of long-term guiding share

right hit So now pretty good to able I think being we're relative sitting to that mark.

quarters. get it do the You can what takes these the there six forward-looking over math upon numbers next on based to

I that achievable are competition are with coming even think numbers those up.

And forward. that good that's certainly going obviously, feel indications to other with build about we trials we baseline other So in renal want of and a off that.

Jason Gerberry

a it. what just there that markets can X lead follow-up Got and cohort cohort And will should arguments opposed the approvable know the going traditional on pathway? I skeptical get if more But X. Phase CRPC squeeze filing, X your could to just into are a be be an FDA you basis I on as

Mike Morrissey

Yes.

we'll topics don't that want discussions with to certainly agency. or the or I comment discussions have on So

contemporaneous trials of I've the standard signal. I do by NHT been blinded care, independent is second review with by as think low relative done encouraging response which rates response an think pivotal in what answer previously, is has a rate a to XX% near I I'll single-digits,

disease the the of rate at in warrant, response dive duration for assessments If on a I the control into response two the XX% think value all, concordance those range. between of the I PFS you and of look for response think, rates, top for promising deep they're

We're about agency it. file. alignment encouraged feel our alignment If with there's seeking the by that. a we Obviously, dialogue good the we'll So define will there. forward. We're steps

discussions other those to there, have it, one that's way So the we're and in or out data feedback. be the going skepticism that upon in case generate based so a path this

but the we good think for portends -- I certainly as we And it CONTACT-XX, that about So too. good it about data. feel -- feel as

Jason Gerberry

Okay. Great. guys. Thanks

Mike Morrissey

Yes.

Susan Hubbard

you, Jason. Yes. Thank

Operator

next the Your line Hsieh William from comes question Blair. of from Andy

Your line is open. now

Andy Hsieh

just Great. a last congratulations and family. record regards And breaking question. her to for taking Gisela best quarter quarter Thanks my like and on

back So of market shrinking levels? just RCC So the relative to you've I half P.J., in the commented comment wondering kind extensively questions, I can you pre-COVID-XX of year. size on market towards think terms of the about last

sense are give also maybe -- we second in new points mentioned relative levels? two And curious scripts, -- you to the just you a currently on I'm sorry, a where the but total have, in about an is total scripts. which shrinking pre-pandemic of increase data on quarter new us in So that the just

if there's of second the curious here quarter? secrecies any Just either in sort

P.J. Haley

seen least Yes. we've RCC the kind slowly we variants, Thanks QX, NRx just to question, the other in what I'm QX we your was regards for I of, QX. I the with IQVIA pandemic regard stabilized QX in particularly But what think say kind across of guess, have saw data Delta has impact about the that as to point questions, as the market the to it last started I'd roughly I in first the generally clarifying, saw kind recover to of means. is at with to talked market impact we make in Andy. some I'll was the don't COVID, regards kind just with with And of start did see sure, of of there. year seen in new of the we've middle obviously, And the quite certainly sort So what all year we NRx really country. market. by recovered any back and data there's cetera. normal – relative somewhat I'll think still from to stable et we're to kind way certainly

that's QX has other big For actually just CABOMETYX. patients was and stable. prescriptions I thing. CABOMETYX because of we there insurance most pretty CABOMETYX, a market Seasonally, common X%, a and our a while mentioned pretty new And line variety this and that declined seen at things. the that's third be is share have see down can bit point are

second-line we NRx, just with a with what very our line. share. internally obviously, and that, So to had data line. of too, seen NRx really data We lot we're mentioned pleased the in growth I numbers share patients patient but a stronger of the track going some estimate. majority first we've saw not we've starts, second that. really in IQVIA new And the have get post-I/O regards closely, the as to We we leading a really which see And more than publicly, what robust and of lot I'm

And strong we're think, there patient our first-line So seeing really is usage. market strong combination we're improving driven XX% I we're mix I that. and patients think in growth, seeing in really CABOMETYX driving by the the seeing an new share on terms of that

Andy Hsieh

that's Yeah, helpful. Thanks, P.J.

So of for think increasing emphasis Six were ADCs program. pipeline. approved accelerated ADCs an I there the Peter, last the is approval under on in

for sense plan development kind take clinical standard a that to Just or of your clinical is trial curious, kind on forward. XBXXX that? Happy going of get of if the

Peter Lamb

Andy. our very Thanks, view And as much the I think well. question. Yeah. yeah, that's Appreciate

you XX commented on as months six accelerated think I based approvals, think to last approval. XX I the in months

ADCs, attractive ADCs one of especially a be think going out the kind obviously being contemporary of And side it's in of of of of active the that pretty to effect balance is find features index therapeutic activity versus able profile. to you early terms your on. I really they're matter

targeting tissue which into cancer. here in So cervical clinical I already tisotumab is shown said, recap the an activity kind factor has clinic been to ADC that's and next-generation encouraging to targeting just advanced tissue there's which vedotin ADC, factor this our for XBXXX, a as is, of

factor got stable get issues should view. a target linker, payload, some kind hopefully of of optimize dose more enable tissue de-risked should into It's is linker as They with a different point factor. we've ways. tissue seen targets that version. we around significant next-generation us antibody. from differs been the of have kind to a bleeding XPXXX It in as different a number which higher on of So a the That epitope well. of that different tisotumab,

over So solid of based Phase different types of fair trial expression as a actually interest. we is ongoing tissue cancer looking see area X certainly factor. about on, number know tumor The at we what of an clinical cervical

pancreatic addition and to with So head ovarian, in our lung, to and patients neck. cervical, have urothelial we intend

data. of obviously setting from the there's Xb into this and certainly, view. cohorts a intent different number appropriate the then places a out So point clinical in from follow a forward And of lots Phase go within growth development an find to trial, of expand – is to to take

encouraging into additional to are to you not patients And say, we a obviously, cohorts designed general that's trials philosophy now. that I have enroll start So seeing enable of as right appropriate. would XPXXX. those explicit we kind signals It's

a So that of you'll see path us take lot. kind

Andy Hsieh

you. Thank

$X I'm of mind. sort strength that So if to things of contributions last the of you happy billion maybe kind don't across of want the Obviously, like lot different changed, different segments provided. – things of guidance you just to I thoughts revenue from the that and question, high-level kind there's your hear indications any you pertaining to revisit different a changes have too. if curious, that and there see kind weaknesses across

Mike Morrissey

be Yes address Andy I'll happy that to one.

going just success goal data and Assuming like, of to JPMorgan how XER a putting in terms behind define whole board big success the a right? a looks seen be, at out generating shift reminder were really as clinical adjust right? franchise Cabo that differentiating numbers hadn't what didn't across previously, of could the those even we of XXXX data. So frame So back just right those the then We we've highlighted risk years. kind as couple in numbers

to you what's weren't to aspirational deck They sure do now not to got relative were I'm in updated and them XX going happening. nature. the So those Slide well meant and which memorized be update all of that again I has we're as math.

to based have you that your if based upon upon modeling please, adjust at your assumptions, please So it. want

making more across who board patients so is pipeline then patients and the the board then cancer Our business therapies on program sure more the advance Cabo that. can the the more effective pipeline across and focus really of based benefit build and better we to address the we bring can need again

Andy Hsieh

it. Got

Okay. congratulations my for agan. all And questions. thanks answering Well

Susan Hubbard

Appreciate Andy. Thank you.

Operator

line from Guggenheim. Schmidt comes next Michael the Your of from question

now is line open. Your

Michael Schmidt

how lot Hi, guess, great thoughts for disclosure the you congrats guys. Thanks share are me. data quarter tracking top-line on question. not CheckMate you that an currently patient into from to benefit how the A for doublet addressed your segment Is triplet on I the that towards might could taking for be Pipeline the clinical think perhaps you incorporated potentially and COSMIC-XXX? practice relative my questions there second regimen? XER is results. with additional to might And perhaps plan? the

P.J. Haley

sure. Yes,

year. previously back full So believe as end the at this we I time achieved of COSMIC-XXX March frame QX in enrollment talked the about of

So an event-based trial.

this year year, end event-based. but projections always our So it's next of early

And a really with So per that Got as view would I – estimate Got we have as healthy we certainly we'll me, pretty air No of accrue the about it. excited We're sense more timing se. bars. better events it. -- Excuse

number with who in of increasing any best what think benefit patients tail really raising different terms IO/IO in disease extending number the the IO/IO are excited both a say IoT tail and in the of some opportunity IO of the with there. of of in have see control could level best who of about combining IO-IO for terms further level We at the you in parameters terms patients of the high KI. of of about TKI a framework terms Certainly

the think across we important next-generation opportunities it's next segments of trial. very, a So very

that notable contemporaneously, to the NIO of. this think that it's think being that's first I for part be is we're triplet certainly done I excited

Obviously So ratios lots game hazard and the of we're p-value. lots in upside. opportunity of of

ourselves obviously. us we this build of on opportunity and continue we an renal. certainly is franchise for much to Media the and in the for the to see success So -- to success then of doing which and have But to too the data continue before XER too CABOSUN really get we're not build

Michael Schmidt

makes That a just then sense. Great. follow-up. And

you to obviously to degree on well. things clinical now additional level studies I your presumably have development perhaps shifted pipeline You've philosophy market. context couple your in do three in this preclinically the invest And a in in-license candidate in point as that's of with urgency towards going continued what closer has product what that early-stage a to at guess a last business perhaps programs to of in years. few later-stage

P.J. Haley

this Look relative consistent and queue of future. a think to year think in complete has we've approach and deals that gotten and near looking last that here variety the I been to overall we've early-stage Yes. the done been executing I our we're relative on year

We look late-stage continue variety at to assets. of a

is tracked success. that or oncology the there higher I years is someone haven't of I over buy to that there's place quite you've like of And that build commercial well. but have has opportunity taken whatever have into not buy that or more probability maybe the conviction we think conviction think really a have just into better clinical regulatory done you importantly I and have but I'm couple there last that frankly than we sure success only lot -- this the a of success, the the launches

or in. the approval goal game that's guarantee the ultimate hazard right over ratio the getting we're commercial and again that right T necessarily an doesn't the with So value line and

to any need deals big do is opportunity commercial we of bets that value success So right make that that we very it's we conviction it's very, the the right the any and high. that big have probability

Michael Schmidt

Thank Great. you and again. quarter Understood. congrats the on

Operator

your of question comes open. and Cowen next is the Yaron Your from from line now Werber Co. line

Gabe Daoud

thanks my This on is question. Yes, Gabe for taking Yaron.

INDs just mentioned updates on fiscal the then Cabo on cohorts some more with Just remain XXX much year the in focusing track? previously XXXX expansion on those the asked potentially curious already. of kind or been on any And pipeline have updates if timing future questions just that? on pretty Any

Mike Morrissey

Yes.

Astec. prepared So in and I say I think XXX from about we remarks already the we've all plan said the question think to

the pass Peter. INDs new over with So, pipeline to I'll question

Peter Lamb

Sure. Yes.

the year. from So XX called you this tumor do an have have previously. a going IND about. Origine also for different a remain exploring be novel can a referred the which we small We on indications. being a molecule mechanism indication for does key for this track collaboration. a we primary see we're solid least It's probably although are at potential we It for saw compound compound novel little preclinically now not on indication It's speaking to of has action a our slide compound bit the coming pipeline to

Susan Hubbard

Do have move want any us other questions, or on? do you to

Gabe Daoud

it. that's Thank you. Yes,

Operator

Olson comes of the question Oppenheimer. from Jay from line next Your

line open. Your is now

Unidentified Analyst

is the for in cabo/nivo This community taking settings. like It Thanks want just on settings our Hello. in We over academic. for academic the have QX about Gisler. the and the the Jay. best to line And ask in question. you growth Cheng to seems the wishes all the stronger community

Also rate sales in-person settings moving in about more is curious related centers Just the community if between and adoption two in interaction these team thoughts forward? the you. the Thank the the wondering just to growth on your our prescribers?

Peter Lamb

the Yes. Thanks question. for

going a And XX% a performance lot to there's in there. in setting have grow they we in and QX. regards think I to that. academics But to from saw I pleased I market of the potential share mentioned some And community adopt we're and of particularly we the certainly, very by a think academic with to we community XX% as, the I have quicker think that. that. -- kind QX with typically pleased kind split We're

I I it education. think that. longer And little to in takes early a the in uptake sort still and think reach days relatively that of broader to the educate the typically of community drive we're in

in the certainly I non-personal XX% community proud I we've a engaging of trends digitally And where the really I now things account-by-account to often referred of that. mechanisms terms and we we the regards this have to But in RCC. couple have am And story to promotion. evolving. variant and done kind our think COVID the little business with things Obviously, by our see of navigating seen right a virtually with or different certainly, have of I and great of And open community of is you're And as which in kind over is is in XX% appropriate the regional give really in now the seeing a as complicated. of lot variety setting certainly makes there person pandemic, the of well more delta think past got there. particularly job resonating we the a kind even grow team yet quarters. think in we're just on and more So we opportunity take educating with are up pleased And earlier. it zoom setting momentum kind of of really great in sort

I there in a as well. see certainly the So lot community more potential things if continue

XX% the the speaks pleased team, start So the a the great just really and and well and share think data is first market with resonating very after quarter importantly with really I performance, in full to the the launch work of physicians.

Unidentified Analyst

it. Thank Got you.

Operator

question Barclays. from from the Lawson comes next of Your line Peter

Your line is now open.

Peter Lawson

Hi. for Mike. Thanks all the detail.

basis around that of how an Just kind you on about think something kind the aspirational Street? that with every updated communicating years? a of Is Just kind be couple that or and The would do of annual that of guidance.

Mike Morrissey

Peter. Thanks Yeah.

I question. Andy I the, question asked that myself I answered verbatim might think I But have already that exactly won't same. the the you think And again. repeat almost missed yes,

So …

Peter Lawson

not something But or be of that's about every updating couple every you'll years. year, thinking

Mike Morrissey

the to question I that. answered when we're like previously with prior Andy. any data. Yeah. what we success looked having of view yeah, going aspirational it, Maybe But to not missed said, you update was That

compelling that define generate differentiating and So if -- that, to market. the would the were we it idea was data based on able clinical

So …

Peter Lawson

you Got of updated, But kind -- additional that approvals, be you're thinking do just to those is you updates? would think about you. how after get that

Mike Morrissey

Peter. the I think, just answered I question,

the next to on question. move Let's

Susan Hubbard

Yeah. right? provide guidance, annual We do

Mike Morrissey

guidance. yearly Annual,

Susan Hubbard

Right.

Mike Morrissey

yeah. Yeah,

Peter Lawson

Perfect.

much. Okay. Thanks so

Susan Hubbard

bet. You

Operator

Your of RBC line the Markets. Kennen comes from question MacKay Capital from next

line open. now Your is

Kennen MacKays

aspirational I that Mike No kidding on hoping was -- Hi. … I'm

Mike Morrissey

it on. ask Come please again. Oh,

do it. can You

Kennen MacKays

channel back have cabo over can a out actually was you're all collecting hoping you're hearing RCC not and I lot over cabo/nivo those decrease good -- combo increase And screening commercial heard again advanced effect for an was go cabo/nivo are I and and for at from of all -- some quarter. you on why reaching prefer competitive or here I docs seeing sort anecdotal and tumors the regimens Thanks frontline rapid of more are in getting surveillance pandemic I on know you're I are given advanced docs any if day. more that did effect. onset and cancer Wondering, all cabo teams. out a if question. information versus anecdotes in cabo's We've evidence the that tumors if of or of other for there. playing any COVID-XX hearing. that's biomarker a congrats there at your

Mike Morrissey

Yeah. Thank you. Yeah.

color then a some and cancer kidney PJ introductions XXXX, back their within been additional words the again, XXXX few since mainstay provide the cabo Look, have in and me time Let commentary. the individual components nivo, say frame. can

mean I a long two when with clamoring and to So remember of when these put a there they almost some I came be the because were some XXXX activity together together. quite in the And on July data file our we data out see results on for the drugs. of good start initial these feedback the molecules from got day let's combination, KOLs, you can XXst BMS and really if is the top history frank combining line was

the great building in we expectations XER or from one There's then headway either combine believe a So start terms clinical great to make commercial to a degree a to in a exceeded teams a really history in data is data can of quality that just tolerability just you and leading very very, efforts. leading large you share a years great with the is testament standing within been was And in team, a efficacy large a the go of together here. of the been months momentum things -- put for data -- to there's the And that quickly. co-leading January five and having life.

itself I the build capitalize and speaks broad think on -- again, uptake and that we're words? it that other going to looking for P.J. So, forward.

P.J. Haley

think profile lots question. they physicians agree them can broad of anecdotes a don't patient I really I think to a to it's with sense in way physicians find the in drugs the we I No, tolerability these they use lot thinking -- utilize the -- if favorable I certainly a whether But there's I the mid helps favorably different of sort which data whether Yes. see And of the where board. patients, the mean excitement the very that rapidly of it view guess I really hear they experience really certainly may patients long-standing knit that your it's of be totality do. progressing many about across

well I continue to So, NCCN option really -- I see represented guidelines is don't many per there's a think use in it the they it's really on think what thing basis. as one is cancer them in see community capita it patients in see we'll we kidney the to broadly. these that gives the And

board So, the how CABOMETYX they all basis get the nino particularly, really can with that's use as think across patients. And comfortable the reframed to tolerability tolerability profile on kind it kidney really got and they have I daily And of optimized of talking has potential combination. cancer use for really think their when we about played dosing in about the well CABOMETYX. XX-milligram really folks profile the the

benefits So, it's think board. seeing that do that to great for lot that physicians a patients variety are of potential and a across has it we're of just able But combination. I valid the

Kenneth McKay

congas and Makes sense. Thanks Thank again you. guys.

Mike Morrissey

you. Thank

Susan Hubbard

Thank you, Kenneth.

Operator

Your next of of Goldman Chris Sachs. the line question Shibutani from comes

now Your open. line is

Chris Shibutani

balance a Very you allocation? how allocation about types strategies? capital obviously strongly not reset Can you of thinking cabo frequently for very cash questions. the Thanks how or much comment prioritization share me flow cash extremely Remind sort the repurchase generating you for those decisions? of from opportunity success whether upon commercially. you're have the healthy the of And maybe

Chris Senner

Chris. Thanks Chris It's Senner.

it same The pieces, a We're about we've to do continue deals break BD of looking that to smaller we in earlier. that the think doing. I Mike of talked So, size been the couple going down right? scope

the understand And answer we And shareholders. continue capital way all utilization how in the we Mike that from the opportunities and continue capital trying do we balance. pipeline. look time. about and shareholder continually. our that's do talked perspective we But do We that I of right to it to think allocation we a best do to a investment for enhance and other return we're -- cash the what's best now to cash to And

we And so, at basically way look the that's it.

Chris Shibutani

you have And repurchase currently? do allocation any

Chris Senner

at and We return do to allocation the currently. allocation it see best on a I have capital the But continue not purchase as look we share said, capital. as

Chris Shibutani

on there for of updating in us to terms incremental I in might the are that generic track the then for May challenges, news? we with And trial it. Got still is believe progress. May on XXXX the be able in you share front anything that anything on of trial

Mike Morrissey

Yes, evolving as process publicly. that go It's Yes, it's thanks. really the I expect, and we Mike. think I into here. nothing Chris really can is process I details share the can't but

So…

Chris Shibutani

with success. your finally, And clinical Okay. then very based for development cabo's the share and KEYTRUDA. team others strong have commentary you Obviously, bench a on support upon

for that think As of and are people, any the you in -- there? as looking furthering core that ADCs those that clinical different decisions, there about just pipeline some any you direction think looking people your the group about that things particularly updates -- of of any of group about of guiding the C-suite strengthening you're

Mike Morrissey

we're question. Gisela. good to It's carefully. we're replace it's Obviously, at very one a looking Yes. that No never going

help that's the level to their to can skill who I really perspective with next I to sets, unique to look bring think us in own go way unique a it. the years their own We're at for somebody fair looking think come. somebody

has her level it's and one now. impact opportunity, success building of organization team and next part and help this organization a culture. this on been want I key her that the Visa the to go her this And So take to

be part about on and brainstorming kinds things basis. kind a right? opportunities that We're We -- of she'll regular process talk candidates those of already. and So of

collaboration able that be this to the in help next level. to us to forward looking go continuing I'm next So bring to and CMO

Chris Shibutani

much Great, Thank you very

Mike Morrissey

you. Thank

Operator

Your comes of Willey line Stifel. from the next question from Stephen

open. now Your line is

Stephen Willey

congrats to Yes. the quarter best on wishes And and Gisela.

guess talking data some that TKM be commonly single-agent gains seeing risk that know kind respect utilization question are we subgroups or all I a guess, look seem know at market. But a are I of that Just know But risk at specific might lot some of when the and and within I just know of most risk the you're to subgroups. you're subgroups? I market the about quick look be TKI of quarter data like TKI quarter in at of of patients. to with occurring prescribed that I adoption guess Votrient I last looks that TKIs the both Sutent, this which the also I outpacing it the favorable share coming the and and across expense

in replacement guys wondering, single-agent a just if initial segment? of frontline you're TKI have is just seeing much how sense the So of that to adoption you favorable as setting a risk within therapy this

Mike Morrissey

sure Mike. to Yes. data not what those you're at come I'm to looking it's conclusions. Steve,

good different markedly different terms of with of clip introduction I are of the pretty either think how our view on single all combinations in that cabo/nivo. at is share agents or the going down the a

Maybe commentary there. some as syndicated research. data as well based view upon provide PJ that's color market can more So our internal both

P.J. Haley

Yes of the uptake did launch at combination combinations. nivolumab. I significant utilization would amount seeing of marketplace we certainly agree. expense of CABOMETYX It's as expanding within with are And we're the IO -- other say the the we

definition see by you there and of Votrient we're So in student the that's taking data there single other the correlation so from agents where probably kind prescription declining.

across taking competitors. think by really all I being first So certainly, the it sense. foremost other nivo share CABOMETYX combinations. the But It's all and really from think really driven makes I board

Stephen Willey

Thanks All taking my for right. question.

Susan Hubbard

Steve. bet, You

Operator

Mike the Wainright. comes question next from H.C. Your from King line of

open now is line Your

Susan Hubbard

Mike, you’re there. still

Mike King

Yes.

I you I peer-reviewed COSMIC-XXX. want the meeting. at FDA ask was a I off about you to data be that to buzzkill to from presume, myself And guys before a trying but presented just had don't get mute. I Sorry wanted just you'll show to

So on that's would have will are inadequate the another if think thirdly, cabo? And is, that can't file, that will I you than primary with the into question. endpoint consider -- that rather Part you FDA you futile, something is expect B But expect survival expectation the part the of guess -- do will expressed with A that you what overall that will say trying same that results taking an study they be a study that -- have to the having do. the run with FDA filing issue on setting XXX to the

Mike Morrissey

Yes.

So let backwards. work me

level that proud was kill a as so high a job buzz that remarkable a this them. schedule time did isn't of enrollment question. getting standpoint from both upheaval really to the at well the in We're done kudos a and First data. during of trial readouts, It great team from the of as execution standpoint a of global on

said we unlikely previously, it's will. that disappointed first we the but We’re interim. impossible, as Not at didn't And that survival hit we unlikely.

that again in, frame. batting we're expectations. but that's trying We're with direct in in that's on news, run hazard ratios transparent literally that we're the game had values to -- of be time and the and and game XXXX, P we're -- right? the That's about we're old be X,XXX we investors So since

not it's pieces while once the sideways of especially moving in COVID. go a going are things that completely to with So unexpected

FDA going all they not speculate say, I'm might being on the what said that So what to might do.

hazard trial significance. level we ratio of very have the with two Now, good one the a a of appropriate primaries and that hit

in decrement no that's agency the see. KOLs about issue framework the which take certainly to terms of an so more talk meetings place, with We'll talk of from and Delta, when. really will happen meetings a see. that with variety approvable. data, of presentations in we the We'll is or important what is to So, marks are see there -- When the complications think survival, question when postponed you being that will

soon to our with I the out we story is and the out to before possible. with think in we happened context there. and to the Obviously, between behind as PFS to that nearness tell OS material the on to that's I'm get see. filing alignment with fact. dichototy data you. this we have information have So as agency not have goal a speculate share get and good what obviously we'll share the around that But once we'll going And

XXX, -- In And goes that's be this done the virtually it we've context, for and will beyond previously. said terms right? that trials next with everything of

what carbon but then the talking That’s the -- we about we oil lung XXX of terms about past, seen full are more liver, network different of types development. renal, So into about tumor purview with forward. prostate, to going haven’t come we’ve pursued that in going activity of about in any

get the we're and ahead a So -- we ICI doublets these the triplets lot think collaborations about certainly now in that value. about clinical bring obviously but will that various opportunity very that and defined and of we've can got excited time all

We're for excuses ball just sure progress. that no make our keep no we deliver day on work eye who can going But need So, in patients hung to every therapies. better hey heads. the and

Mike King

Okay. Thanks, so much.

Operator

questions. there At this time, are no further

And so host call today's will Ms. Susan turn Hubbard. I Hubbard? the to over

Susan Hubbard

Yes. Thank us today. call. address welcome during We today's were all to you, calls may additional joining and that thank for your Randy you with any have questions you we unable follow-up

Operator

your gentlemen participation. call. Ladies this concludes and you for conference today's Thank

You may now disconnect.

Exelixis (EXEL) 6 Aug 212021 Q2 Earnings call transcript