Earnings call transcript Q4 2022

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Fourth Quarter and Full Year 2022 Financial Results Conference Call. My name is Vaishnavi, and I’ll 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 financial and call. Vaishnavi, the us results you fourth Exelixis full thank you, joining all for conference Thank year XXXX

me full who will our our progress Mike Chris Joining fourth our ended review call quarter December the CEO; XXXX. and Senner, Officer, and XXXX and Morrissey, Financial Chief for today’s on year President are XX,

on Officer; Scientific President call. our Commercial; Vicki portion also Medical Executive Officer, Chief Chief our Vice question-and-answer of call will and Haley, and Lamb, P.J. our Peter our today participate the are Goodman, in the of

During an will accounting measures not principles. call of using for explanation on release, measures to accepted calculated to results. refer financial posted today’s press our well these results the measures deriving today, non-GAAP as we tables Please which from such generally for according as GAAP website to our is refer our

we future This future making of regulatory, course be results forward-looking strategic will commercial, the about financial statements differ includes of regarding statements discovery, performance events course, developments and materially. possible this product During could, or Actual regarding development, the and the presentation, matters. events of Company.

Company to which activities. of regulatory success, and our important cost level related product cause commercial to from we clinical and to documents market uncertainties with partners compliance processes, and the and business verbally in to differ product collaboration development discovery, with Factors and without time results dependence trials, requirements, regulatory risks actual writing including, applicable expressed commercialization SEC, development, We file competition, conducting limitation, associated approval the on factors those with you under refer the by review Risk the heading could today, the time identify that from materially

to Mike. And I over the will now with call that, turn

Mike Morrissey

you, call All joining Susan, on everyone for to and today. us Thank thanks right. the

and fourth strong a quarter business. across full of components XXXX our had year Exelixis all

priorities and U.S. the in our and to the fourth of future. portfolio globally see while build quarter the continued development the pleased cabozantinib full growth to product year and in Exelixis We’re advancing franchise ‘XX the discovery of

a top the As we had of financial priorities and the a ago corporate highlights summary at I corporate Q&A Healthcare quarter Chris provide before and will complete and a key with for JPMorgan full Conference, into fourth few moving the XXXX team. weeks update

the franchise to we have with continued and in I-O to of XX% demand First, product in cabo Fourth year Cabo the first-line XX% year approximately XXXX. for U.S. grew full since XXXX doubled grew business revenue leading maintained RCC quarter revenues and the year-over- for performance and XXXX. the the compared full year in strong franchise compared net product monotherapy saw segment. a status fourth its net both cabozantinib quarter revenues second-line of CABOMETYX as the TKI market TKI growth XXXX

review Importantly, full global prepared approximately cabozantinib $X.X Chris its guidance respectively. revenues and will franchise XXXX, and Exelixis quarter year financial product billion were partners remarks. $XXX the net fourth generated in our his and in by XXXX million

development advance full expedite the with expansion pivotal to with of development the XXXX indications, Exelixis new this goal top our Second, is agent moving potential combination by cohorts with pursuing priority and cabo zanzalintinib, and monotherapy for into year-end. pipeline XBXXX trials new development

development and biologics range preclinical organization and towards INDs development candidates is both for small towards in XBXXX a XBXXX, vectoring of additional XBXXX platforms. molecule projects discovery Our potential advancing with

advance an those new possible. quickly throughout and get are activities efforts Third, critical with closely as as will teams their off option option working The and we’re to a for Sairopa Cybrexa business deals focus two a to to XXXX. be development great to with continue to Exelixis decision start,

to that patients will if data resource have efficient that Our primary and framework clinical differentiated is continue benefits capital be near focus a clinical only in way and/or to the generate The for deal to clinical with is XXXX. supportive. strategy assets success option cancer stage to access provide proof-of-concept to pay and our potential data

the of cabozantinib XXth, its Exelixis the ruling polymorph the ruled product issued and the MSN was Federal challenge compound And not I. rejected January the N-X District case, dispute Court generic as finally, MSN we MSN in the patent MSN’s polymorph infringe not versus validity to MSN’s to on to Delaware first refer validity patent. N-X was did patent. what proposed in Exelixis’

patent it cabozantinib So, property been in invalidated. -- so intellectual valid state also no and force it remains has is the also in Exelixis and

property to attention resources MSN protect to we October, intellectual vigorously and our Our continue rights. now trial have and goes shifted II, will in to which

So see for key fourth issued and an I’ll in Chris. press financial an year quarter of to our the hour full and with that, call the list release corporate turn over achieved quarter. our XXXX results ago milestones now extensive

Chris Senner

Mike. Thanks,

XXXX, Company quarter deductions This included than $X was in net included revenues the line of franchise quarter in gross which the of for revenues XX.X%, and expectations fourth increase product and for our total of ‘XX XXXX the co-pay approximately franchise primarily D approximately which product $XXX to Part million, Medicare net the CABOMETYX net in $XXX.X year. cabozantinib in we sales. cabozantinib million. in clinical trial of were to net the expenses. of For the to million reported $XXX.X gross fourth experienced XXXX, quarter million net quarter is higher but PHS, higher assistance in fourth revenues to related with third the the overall Gross

the and when been by increased This XXXX increase of Year’s the at New Our in has holiday of end approximately see inventory we the trade, few XXXX. in weeks related what can hand. most Based of of XXXX third of on of the this units weeks the in and XXXX. utilized partially XXX first beginning January on the was the Christmas to inventory timing CABOMETYX inventory X.X to trade compared quarter approximately to

which in between continue choppy and revenues quarters, $XX Ipsen of Total cabozantinib. royalties collaboration revenues $XX quarters. And and trial sales we million have approximately from clinical sales earned on this their in expect to finally, also been included historically of approximately Takeda future includes million

operating expenses million were quarter fourth to million quarter compared the total approximately of $XXX XXXX. for of third $XXX Our in the XXXX

the added we the expense increase total expenses, taxes to operating the driver primary a $X.X was of quarter for provision expenses. three $XX fourth approximately quarter, income fourth for of the primarily quarter taxes which during compared income third approximately approximately XXXX Benefit million licensing to our R&D million of for of million in the expenses was R&D from deals XXXX. for the higher which to business was development $XXX related announced

Company net the of per net and the quarter $XX diluted was share The fourth for million million XXXX. This loss reported $XXX approximately approximately GAAP in fourth announced by business impacted quarter of loss of new in XXXX. development or we the $X.XX deals basic

discovery expand Exelixis to a pipeline. our non-GAAP and Cash loss impact approximately our of with ongoing December ended The $X.X by of $XX internal million external activities us XXXX, reported Non-GAAP net or cash business provides basic also year the stock-based flow also income share and $XX Company invest supported investments compensation excludes income in was net operations from the of cash level approximately allows expense million the opportunities $X.XX investments per diluted. approximately of of and flexibility effect. to tax for pursue related net and the to This billion. XX, development

XX to And our detailed January finally, our earnings is full announced financial the the and XXXX. JPMorgan of financial turning in our slide on guidance for year We guidance at presentation. XXXX conference

And with over I’ll to back that, the turn call Mike.

Mike Morrissey

All right. Thanks, Chris.

the today, we team and on XXXX heard had have greater XXXX, you call year the beyond. a in expectations great Exelixis As even for and

Exelixis cabozantinib momentum performance on have and all we’re the are As business completely in drivers that thrilled components our the we cancer of will we patients this hit franchise hope from help to stride our more growth future. year, many the across to the enable focused

close for I’ll The cancer entire fulfill to and day activities. our expectations patients of thanking set discovery, their our We and highly drive results. Exelixis high recover motivated by mission development efforts live commercial is to and and range team help team to support collective our stronger individual for the longer. every

and being call and forward interest creative updating culture progress now XXXX, engagement. look to in we continued committed And and While a We grew of the support and in remain our collaboration on to considerably we’re your we you in the foster to for open future. nimble Exelixis. to for you Thank happy questions.

Operator

Instructions] Goonewardene first comes from ahead. Please Truist [Operator Securities. question Asthika go with Our

Asthika Goonewardene

my And noise. taking background streets for in question. apologies Hey now. Thanks City York the right for New I’m guys. crossing

XLXXX, ESMO seen just from data Just get know year? last as I we you can this we’ve expect read what of at a data to I year. to previously, on kind want

to those updates Thank get Just that idea can combination wanted about expect. you. we to an -- studies

Mike Morrissey

Vicki, No right. jaywalking you take question? do want Hey, All to Asthika. that Thanks, okay? please,

Vicki Goodman

the Sure. Happy to. question. for Thanks, Mike, and thanks

where XLXXX and compared half-life now profile. of first early the to see evidence and it’s terms of in in the zanzalintinib, again, we overall terms course, at cabo, confirmed pleased activity which, last clinical safety shorter ESMO So, the year, we’re data presented to of called, a as profile of tolerable

recently of heavily cohorts Xs our year We’re that Phase as initiate plan studies. we expansion year additional the Phase in execution well Phase initiated on terms to this that as we’ve Xs ongoing the on X focused this and

any data present, that be in on updates have but presenting terms timing today. for set specific meaningful don’t we’ll And so, we additional I have as data a to of you

Asthika Goonewardene

taking you jaywalking. And no my much Thank Awesome. so question. for

Operator

Please Michael The comes next Schmidt from question ahead. with go Guggenheim.

Michael Schmidt

powering some which arm as understand then, key CABOMETYX growth assumptions Thanks product assumptions in year the the secondly, control from me. Just sales And the post-hormone so two mean, in for XXXX on therapy CONTACT-XX this your ones key on quick much. trial, help help for CRPC the the setting understand first, the us for is prostate for of well your as cancer. study, just is guidance, coming where us CABOMETYX. I additional

Mike Morrissey

Thanks, Michael.

then provide Vicki first second don’t on you and can start; over on that Chris, -- pivot why P.J., you question. as well; to some So question, commentary on we’ll the

Chris Senner

Sure. Michael, Chris. it’s

around our haven’t And market growth. range That to sales new And from all And of you any dynamics in -- that assumed as indications, guess the to we no So, $X.XXX talk in I comparator know, growth the coming XX% can $X.XX guidance from XX%. of growth billion. billion there. P.J. is new is about has indications. current

P.J. Haley

regards the Chris, the I-O and With and TKI the XXXX also number a Yes. year finished number question. not only strong one thanks Thanks, the and business, we RCC, to but TKI the had one for monotherapy as combo.

talked driven market in increase an about so new we share duration. particularly in by increases of seeing months are four starts. we in the patient continued previously, from saw And or we’ve last increasing year, demand growth As the

to excited So XX-month in XXXX. presented have certainly growth, XER believe, top both of support GU the that we data that, those together ASCO of study the marketplace. further positioning should at and fuel our follow- up believe On will we’re in from

growth that’s XXXX. how in So, thinking about we’re

Mike Morrissey

to That’s P.J. at Thanks, the Vicki, do you want handle high CONTACT-XX level? great. question

Vicki Goodman

thing. Sure

in cabozantinib cancer. of in So, this CONTACT-XX, mentioned, you terms our as metastatic and atezolizumab study prostate of castrate-resistant is

for the in powered as for both to endpoints. survival year. expect those I can we And a survival terms meaningful say what of power, overall announced, half endpoint we’ve progression-free have the survival As effect as this second data the of it’s demonstrate well in to two progression-free in is

Operator

with The from Sandler. Piper ahead. Kim next go question Do comes Please

Unidentified Analyst

for Do Skyler for my is taking Thanks on question. [ph] This Hi. Kim.

leading given if you cabo CONTACT-XX the share believe speak the to market and line I’m monotherapy you RCC, second what incremental just is, you where upside see can the revenues? the Regarding study, already opportunity is wondering

P.J. Haley

for is Happy P.J. Thanks to that. Skyler. This the Yes. questions, address

options. as CABOMETYX CONTACT-XX with market a mentioned, XX% you second we patients in and line the approximately -- position monotherapy. have So, greatly in have setting in and metastatic of with better more But disease, they’re these still certainly, share need RCC strong -- they

to So, of adds cabo that that opportunity kind we different about ways. should CONTACT-XX be setting, positive in and couple think of in a atezolizumab

XX% in would for believe do of we much And better that monotherapy that that we data, we CABOMETYX the XX% beyond convert share combination therapy. backbone from of One sort to CABOMETYX is, believe setting. market with the can expand

share you as potential then longer we see And that in duration a expansion. a market there. double of setting, would we expect So, see therapy

market CONTACT-XX. cabo of duration the how is think from expanding longer about framing growth both therapy a we the So and

Operator

with Please from The next go Credit comes Weiner ahead. Suisse. Geoffrey question

Geoffrey Weiner

that was which on that announced in And recent Congrats here, Ajinomoto ADC addition tech a one is have progress. January. I stack. I think most the ever-evolving your deal think I just the to

already capabilities So you with there got the and bit just wondering have. those talk specific you. little you if the more partnerships deals can Thank technology a access how about and to you

Peter Lamb

Yes. question. This lot a is Peter. for Thanks the

our on most That’s to of right. antibody absolutely of of conjugate You’re the suite side. addition drug the collaborations kind kind recent

also we’re really network most think a through as internal of both of some pipeline, people advancing our I know, kind but through efforts, ADC collaborators.

Invenra who those platform. our some of also very that collaborations are And site-specific makes is antibodies we us site-specific have We is have technology then range a different and a really to Catalent give as And conjugation of Ajinomoto nice payloads, as most well another to NBE. of technology. access couple a conjugation access and a bispecifics

So, certainly been the very using X side it’s it happy research we’ve for been way -- on with the I’ve months now. performed. X

ahead went the we So, with deal.

drug with ratio. but of make variety So, we’re antibody a different to different using ADCs it very a payloads, controlled with

Operator

question comes Gerberry next from America. with ahead. The Bank go of Please Jason

Jason Gerberry

that XLXXX, STELLAR-XXX is we’ll I just impacts was ongoing know direction future of the wondering of sort dictate here mature. message data cabo sort future the future the terms the in course one, of program. of as what trials get of updates Just I

So assume probably table. takes prostate explore in not i.e., long you’d off CONTACT-XX, setting. the XXX that the I’m or if dictate say will I contact-XX whether you’d curious

the CONTACT-XX. to that. on trial restrictions in frontline? XX% follow-up ability just given expand beyond having patients primarily who is that in that one clarify got a protocol just the to setting, The regimen line, cabo around wanted second-line Thanks. just then non-cabo And front gotten I just in the share

Mike Morrissey

can and Jason, up second? to questions. a want for Vicki, then the you Yes. P.J that take first on thanks question, follow

Vicki Goodman

Sure.

zanzalintinib, early is said STELLAR-XXX, of Phase to that cabo. zanza last we before, we I a prime was we’ve data so the that combination that from cancer. colorectal inform profile, and with data started are program X we or So demonstrating cabo again, the promise started as year, the Phase this the And last was is that atezolizumab we the of at based presented zanzalintinib. XLXXX year, terms looking using in first have which it example think a of on kinase And And with of that X similar and development. non-MSI-high

that’s in evaluating off Obviously, terms lung best a a data patient say in consider I to we’re necessarily trial. based I about comment the the develop of develop population zanza in lead difficult to that think cancer table from drugs. to careful think lung I And CONTACT-XX. how that cancer, the wouldn’t may of is population. data which evaluation us on lung one

P.J. Haley

is a with Yes, in assumption your P.J. form, the should market receive the assumption setting, regards is that it who second we didn’t It’s should positive expanding share, that and in cabo market of be to first-line positive? in question, trial. to patients some share still room -- should expand there line with a CONTACT-XX, for either there combo monotherapy the or have The

Operator

The Andy next from question with William comes Hsieh Blair.

Andy Hsieh

compared the like AUC to maybe I’m efficacy Cmax let’s help potential a zanza, just tissue us gauge maybe or period. on for And distribution comment over the the could superior like So for curious cabo, profile. to characterize say, a XX-hour you just if

question. unmet that first STELLAR-XXX a non-clear Number see the glad very need. study, cell of medical my two, that’s to So, high really start

a modeling histology, give difficult standpoint, non-clear So, percentage could of a from cell I to sense cribriform are understand Specifically, the eligible really [ph] you what for excluding us treat. the it’s patients trial? of

you Thank impact curious that TAM. we’re so, very about would And the how much.

Mike Morrissey

on Peter, zanza? to take first the part do the of you want question

Peter Lamb

for Yes. Thanks the question, Andy.

half-life modulating And we’re has XXX zanza, half-life nearly to but pharmacokinetic showed last year, is that still focus to reduce in significantly were around it we take late of daily we it dosing. hours, obviously, is once properties a around the which was with hours looking zanza from XX accumulation, that. cabozantinib happily So don’t -- have -- much patients, with what developing came as out We on shorter. the as so see data in as consistent it’s the

So, achieved. initial that goal, goal, was the at was least, which overall

and fractions dig we’ve AUC, to of drug three sort kind at well. obviously, as question, the of that looking drug data of looked at Cmax, start level, into you If actual your calculating

that that to approved are very we’re of pretty doses cabozantinib. similar the confident doses at We’re

I biomarkers, what think respect VEGFR of to up calculation poster saw we is that and with that on again, put various very AXL, looked example, changes for with which backed we by as changes historically the similar VEGF, of some the also well cabozantinib. to

we efficacy see So, I at was but showed poster the management reduced nice to the forward. end from easier I of AE think day, in the in waterfall spot AUC again, half-life to which think expect we nice we lead certainly with initial a And with to going respect we’re us, and should encouraging the think to what a with pretty plus, Cmax efficacy.

Mike Morrissey

do to take you Vicki, the want Fantastic. second question?

Vicki Goodman

to. happy Sure,

overall, terms cell. makes XX% of up in of cell non-clear that. most non-clear of So, about actually is renal Papillary carcinoma cell

only about XX% RCC the whereas of population, So, it’s about overall is chromophobe X%.

almost So already between XX%. at you’re papillary unclassified,

So cell again, for the patients trial of RCC majority would treatment. be eligible this ultimately and non-clear for with

Operator

next comes Markets. The Please Darout with Capital Etzer ahead. go from BMO question

Etzer Darout

got data the saw one Just CBX-XX, We signals in initial for for some interesting your meeting there. ovarian and me we breast or data some at cancers.

to if wondered update this expect you. development? could that update Thank year sort or a Just with on plans program, we any future for of respect clinical

Mike Morrissey

do want one? that to you take Yes. Vicki,

Vicki Goodman

Yes.

in early obviously early we’re the showing even we’re responses by also So dose data still some encouraged escalation. while

be escalation. informed early we’re the that Phase obviously, stage in moving development, expansion by tumor clinical team at range be forward to say following dose a dose some looking So would would last point we’ll into them seeing year, will and working that, work I at and achieving dose in in late Cybrexa again, X data the of that a of update which escalation with to future recommended which still next really on updates. types, the we’re of this with

Operator

Akash comes ahead. with question Please Jefferies. next from The go Tewari

Unidentified Analyst

This for [ph] is taking for Akash. questions. Eyli, our Thanks on

So we may. have to we if

the first spend. The about is R&D

positive So, program given XXXX spend seen years, my in your guidance? I confident invested is what to some what’s you larger M&A question And on also, return a what’s of roughly your do of that in feel show programs $X do R&D $X the the billion on to your will cabo. guess, breakdown a capital? transaction? setbacks I last couple billion we’ve And guess, appetite per most like second the your of

next a the growing will do curious, be alone? three you still just So, over RCC just think years product on cabo

Mike Morrissey

there. There’s lot a

those may have a Chris, So, back check sub we’ll try But, take one? around to at time. one We answer you questions specific to questions. the with first

Chris Senner

enroll. an and is From perspective, we’re I expense the R&D the at increasing the costs coming continue the what the seeing XBXXX down, zanza we’re costs as to related those study cabo mean, we continue look Sure. related seeing grow to the we’re and to XXXX, will and the is as to studies future seeing studies into

And where continue a increase do discovery big what’s at then our year in the including we’re perspective, from those. the to to look driven deals, discovery BD and we’ll this continuing investments, XXXX

Mike Morrissey

Yes. TKI out line. leading the terms And to RCC for second years, TKI guidance I-O market obviously, not future first -- for as going I’m well in as of give across line the

data, trials So and data opportunity in we’re between good. those again, the growing so to we look the business. keep good XXX CONTACT-XX, And going have gets the but business,

tuned. stay So

Susan Hubbard

And was deal uptake. I her point think of larger question

Mike Morrissey

Yes.

the that about won’t qualify larger It’s asset the pursue and potentially success. assets for all of obviously. Okay. about opportunity larger for -- deals size, in we’ve probability looking while, that And to later-stage been talking -- conviction a that’s the the and

generate data forward those then and commercial ability on then can differentiating the view that we move of that into Our to assets the setting.

use is we and we and data, it’s plan. doing can I we’re to top again drive proven that the of can and think the differentiating say, do certainly and and have line through cabo, external it to -- and we’ve to that it sources think I that we both fair that with internal generate growth clinical proud when we’ve again understand again

So stay tuned.

Operator

The next Werber question from Cowen. comes Yaron with

Yaron Werber

questions couple a on pipeline. of I the have Great.

is first give is what’s obviously The that RCC, that us interesting. are PD-X really LAG-X approved with first And which it in, in? share, Opdivo for combos interested of in the in is on melanoma. or LAG-X RCC? say, a the right And now has segment? a STELLAR-XXX, non-clear little -- tumors sense, showed -- bit What PD-X Does line? sense, it’s sunitinib just other one let’s Has LAG-X solid then leading dominating segment any cabo cabo that’s have drug or in you any really

Mike Morrissey

All right. Great.

Vicki, then you question, want the address Yaron. can P.J. So second? first the take thanks, to and

Vicki Goodman

Yes.

is noted, a relatively interested sparse. now that across other as LAG-X data, tumors. in combination Other are say, the domain So nivolumab would public of in tumor we’re melanoma. the different across with you approved I types But in are combination right in solid range

tumor So, GU not hepatocellular and we’ve types carcinoma across other to such RCC, evaluate expanded solid now really that only the but including as that trial major combination, others. tumors, major in several in tumors,

So, really it of what an interesting combination that will we’re looking activity. terms in forward up show to

P.J. Haley

Phase as With guess But a what has cabo is see setting. Combos RCC Yaron, in characterize regards -- currently, guidelines get guess there’s what clear similar I’d Certainly, think utilization. relatively -- this to non-clear the utilization is well. X cell. market, X that market that in overall it with we see no Hi including P.J. randomized you Phase study the cell I it about as in good I to I how market. There’s

level should data medical So, high available. a X be study of without there, it’s I Phase of need a there a think, positive unmet significant area

that setting care So, a opportunity I lot for of new to think really a those the an of provide standard would drive in patients.

Yaron Werber

of much is throwing if that the can, how quick I fast Thank gross over grown just time? just you that on give question, program has net, given XX.X% at all, to a any maybe can us sense XXXB And how you.

Chris Senner

that to the of we mean, Yes. number. range XXXX. think give it’s question. in continued specific net so. not throughout to and is gross prior QX we thanks be as go you higher the to down going in for a seen as the -- in question. year thanks went I’m QX. Yaron, throughout Yes. saw in years, grow QX and for at as And and then look the XXXX, -- year QX, going or I But the we through XX% to be we But we’ve

Operator

comes Please go question next Jay Olson from ahead. The Oppenheimer. with

Unidentified Analyst

Thanks Hello. taking Cheng on the question. This the is for Jay. for [ph] line

separately, think for higher to cabo, ‘XX. there’s second mentioned is start I think you continue and whether maybe X patient that trend studies. will that to And new whether the I first-line you expect So more -- the in in on zanza, maybe in half XXXX? Phase will initiate patients due curious that And wave setting just press mentioned of release, in you next the

terms So some X the study also Phase should you. expect? the and the indication maybe next wave color combination Thank of on of we approach in

Mike Morrissey

Yes. over question the the to first Thanks one. then question. and for take P.J. for the Vicki second can

P.J. Haley

This P.J. is Yes. Thanks.

So RCC. new starts, that think increasing not to from in I with regards the patient first-line patients epidemiological necessarily setting new an

the taken in competitors, we’ve half we’re is second from particularly share there year. I of think seeing what the

level. a at I think executing the team is high

We that’s have data survival, and of of tolerability and marketplace. strong quality life, and in balance is safety, a great the overall perception of superior well data received and that of in terms

increase helped opened the opportunity think momentum So year. things the of half new additionally, the in interact patient up data, starts to us drive more pandemic, and and healthcare gave with the professionals after the really them educate kind I on as to of second

Vicki Goodman

to happy more cell as in cancer color XXX reminder, I’d as with we we multiple colorectal XXX provide we’ve and announce just there say, certainly initiated we’ll initiate And once of carcinoma, additional last mentioned, so pivotal course, microsatellite non-MSI-high our be zanzalintinib, and trials. respectively. a trials and stay STELLAR- for XXXX. program those in non-clear pivotal intend to year additional tuned details, And cell we with renal

Operator

The next question Please comes Barclays. from Peter go Lawson with ahead.

Peter Lawson

Great.

the when should STELLAR-XXX data zanza, be see and Just PFS interim then and thinking reads sets for any we kind there’s or on the XXX next data next should that about? of we if

Mike Morrissey

again? you question Thanks, to Vicki, Hey answer Okay. Peter. that want do

Vicki Goodman

Yes.

months XXX months specifically, terms and initiated last in trials -- XXX are of or for that these So, course, six so. in few we’ve X of the Phase just or

enrolling really getting up we’re countries now focused So, patients. right and on running,

this In will event-driven. of timing, terms all be

And data, be to this when stage said sharing I conferences. The will we we those say earlier, those so, would at early available. meaningful X I at a are too as more those forthcoming medical data but when we’ll analyses, set, it’s details Phase say, have have as we expect

Peter Lawson

a for But revenue clinical question sales I for contribution Chris, then for would be ‘XX missed And it. the trial QX great. or

Chris Senner

Yes.

it Peter, the fourth million quarter. was about $X So in

Peter Lawson

And not continue you don’t guidance? expect or that just your that included in in to

Chris Senner

All I’ve numbers. our guidance we’re not in is that including said

Operator

Please comes JMP question from next with The Silvan Tuerkcan Securities. go ahead.

Silvan Tuerkcan

I quick a Just triplet thinking about into question. And that getting from how could the that may your next are there at in that? eventually with by be some the please learn we maybe saw COSMIC-XXX, this data ASCO in with GU week of we so Could you readout? next remind where registration? inform risk RCC score. me could frontline What And terms

Mike Morrissey

question. for that? Vicki, want Thanks do take the to you

Vicki Goodman

to. happy Sure,

readout with more see year. survival and for data a considering mature the COSMIC-XXX, to survival last discuss immature. progression-free So did as of just that overall We the FDA asked data the the in reminder, primary of endpoint terms survival point, At we were data before they a had filing.

we have overall later are of this survival current that second interim projections. based on So, analysis the year expecting we sometime will

the with on we a or about not depending appropriate. FDA whether appropriate, have would As data, would a filing be conversation again

differences the point, any But looking and and so see ASCO In safety a in we risk those risk details. can’t poor have intermediate again, an this they’re at at enrolled data, we the study risk terms across share by groups. of presentation yes, just whether still do I category embargoed IDMC patients the GU profile benefit and really,

Operator

The Mike King ahead. next Hutton. go question Please comes EF with from

Mike King

my you and in know I around. I’m sitting right office, there’s want I’m traffic actually to chair in quite now. safe my no vehicular just that comfortably

your appreciate interest. I So

and Just data real like a I’m thinking have X of that and have quick just is some to just going you waiting now? or based Phase it of to you that right -- are for Phase purely conceptualized be menu you on zanza X Phase the the on trials about guys do trials data-driven as -- do sort going well. wondering how of having confirm you X those, you’re

Mike Morrissey

Yes, you that Mike, great Vicki, to take want do question. one?

Vicki Goodman

Yes.

your safely glad I’m you’re first, in So office. seated

In from again of a looking at of development, different terms we’re data sources. zanza number

also cabo in future increasingly which will Of back development. again, the but may from XXX, in inform from also coming looking study particular, cancer and from emerging ongoing at referencing data, our zanzalintinib of looking data be cohorts, course, STELLAR-XXX, colorectal STELLAR-XXX, all

also we’re at areas where we that opportunities consider really here best looking really factoring for next evaluate said, we’re difference all a places unmet landscape, as and patients, indications what and can for of so make the we zanza. need, and information of the That competitive are to

Mike King

would take because those perhaps about and for let’s that that I those has market bevacizumab some say, it? you where think good not or cabo the sunitinib there’s indications are pazopanib or that, Yes, think Is to way could are areas where indications a share.

Vicki Goodman

we it then be I think we so, at where look there would have those where Certainly, other a shown develop may And activity right? about place can might that, is as cabo areas then say of think of evidence great combinations. see because, is sense a nivo-rela we I example good makes a could -- -- at course, the unexplored of we where combination good combinations, to novel different Looking be where have kinase activity, possibilities. lots profile, but to also TKIs looking of similar well. particularly

Mike King

Right.

But what would important data just to important what’s say the point then a really litigation? milestone outside the holders Exelixis at from ongoing to say, And year? you the the this high most investors is Okay. of, just most let’s level, portfolio, MSN

Mike Morrissey

Yes.

remarks, it’s is us for in Mike, We in prepared a main we’ve and advance of step and to large Mike. it non-cabo across And development, strong up molecule priority been and talked the unmet like molecules even that So and cabo, both our coming pipeline the zanza are the board, one more. then medical patients a pipeline about business discovery few with first both certainly, zanza to franchise have XBXXX. cabo think want well. we successful that companies the the and have very as there’s XXX we in and direction, collaborative for Obviously, need

from of hands get into So, pipeline we focus the and and of line as is as can building get clinical and over possible. quickly HCPs regulatory view a our goal patients’ that a then molecules point

Susan Hubbard

do have questions? more we any don’t. assume we I Operator,

I very myself a much us give you So, call Thanks follow-up would questions. for have or And say thank an you you’re email us if shoot to again. joining certainly, welcome any today.

Exelixis (EXEL) 7 Feb 232022 Q4 Earnings call transcript