EXEL - Earnings call 3 2023

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Third Quarter 2023 Financial Results Conference Call. My name is Gigi, 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 Call. XXXX Gigi, the us you Third Exelixis Financial thank you, joining all for Thank Results Conference

us me Officer; Chief are CEO; call of Commercial; our on our our President Aftab, Joining and progress Chief Peter our Peterson, Chief President Medical Scientific Strategy for Executive XX, quarter Mike XXXX. Lamb, XXXX Vice Chris the EVP third Q&A call. Dana Officer; will Officer, who Financial Morrissey, our Amy the join for will of portion ended the review P.J. Scientific our and Haley, Senner, our of . today's September

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

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

Michael Morrissey

on CABOMETYX our and All active business. today. right. Susan, of Thank had Exelixis the potential continue you, third programs us strong very all a thanks everyone the Exelixis a both quarter discovery pipeline advanced components while across of range to and We're in excited scope future. development we for the call size and build joining to see to grow, franchise the to and of

Our growth revenue of strong third the goal the first, its standard patients in care and RCC. cancer. include: quarter the improve is to U.S. in of the demand for Albumedix as the performance with highlights Key TKI will continued with maintained cabozantinib singular business for for leading status

Third progress XXXX, revenues on quarter franchise quarter were commentary million the million and product U.S. financial update our the our approximately in approximately and [indiscernible] net additional J. commercial $XXX P. will of globally, $XXX and provide and Christian respectively. in activities.

on Second, patients spanning in [indiscernible] a needs. strategy, for and and our pipeline activities commercialization the in level of high on large high join R&D at of progress with highlight build to and have to today, upcoming We'll and recent into our third excited our New medicines in December is them integrated development R&D as details unmet investor past medical highlight December. Amy quarter commercially XX PJ event will and Dana cancer discovery, populations top that a dive City. differentiated deliver we at I'm priority clinically and York me cabozantinib's

in sustainable with the shareholders. we broadly to our is continued day in elaborate more for R&D cancer, our strategy opportunity long-term serve forward forward and efforts propel years, on more upcoming to many to had generate to look we've Our the first patients the all and value organization

clinical differentiated agreement global solid in access to as development inhibitor and the license of [indiscernible] small to unmutated commercialize a context to exclusive remain develop and clinical an business we continue of as USPX, potential opportunities generate lethality In see September, molecule XLXXX, tumor which in activities assets, data announced [indiscernible] target indications. best-in-class tubes. Exelixis priority Third, a rights an to important synthetic granting for Exelixis has potential emerged

the Fourth in feel components the presented last confident any for ruling, want of very we finally, the place now a the last our week and second of on cabozantinib or or trial We took the in and patent week [indiscernible] get the Delaware. potential case either speculating is submitted, commenting District and ahead by the The we state. strength of Court trial today future. in court overall at don't U.S. case to

So please results financial over go quarter. in to corporate of press list quarter for now our highlights issued release our and third turn see achieved with the call key that, an to extensive I'll the the Chris. an hour

Christopher Senner

Thanks, Mike.

of of $XXX.X approximately the third franchise which million quarter company reported approximately product net $XXX.X million revenues clinical XXXX, were revenues net CABOMETYX and trial For million. of the product included cabozantinib in $XXX total included $XX revenues million, sales.

choppy Based a to expect cabozantinib and future for clinical As net trial continue historically this quarters, the have slightly franchise the XX.X%, in to increased XXXX sales quarter in between reminder, of between months which will been third we XXXX. compared was Gross quarters. estimating for gross the X be XX% when full and XXXX. second the XXXX, XX% the our to are in of quarter year gross on first net we net to of to

[indiscernible] when cabozantinib Our $XX XXXX. territories. approximately second to respective sales Total XXX of inventory also revenues, units million revenues their by approximately their quarter including CABOMETYX included earned approximately the $XX in in of collaboration million of trade compared increased from on royalties

XLXXX. The of in-licensing $XXX of related driven in was in the compared the the approximately quarter quarter which associated in million increase second of total operating were for expenses upfront was to of operating expenses to XXXX. million $XXX the by XXXX payment expense sequentially third total R&D XXXX, third million quarter primarily higher $XX Our primarily with

QX offset by expense. declined partially fees, compensation proxy compared stock-based This to in higher expense SG&A XXXX. lower XXXX was QX advisory to attributable when Our decline

Provision approximately XXXX. the of for basis $XX.X for for per XXXX or to was The taxes million quarter quarter $X.XX for net company diluted share third of million quarter for a compared income GAAP reported income fully XXXX. a approximately third the on million income $X taxes the of $X.X approximately of provision second

Third or payment R&D on income reported quarter $XX net net $XX company related income a and also upfront impacted Insilico. EPS were fully per primarily the to million diluted The approximately non-GAAP share expense of million $X.XX increase by basis. in the to

excludes for expense invest the our This impact approximately income discovery investments the repurchase in million our opportunities activities tax supported provides ended the Exelixis to shareholders XX, compensation related capital million announced to stock-based of business of XXXX, this our $XXX and of pipeline was return quarter development operations ongoing flexibility billion. external net the share net Non-GAAP with program level pursue September through effect. income of from approximately to to of increased $X.X and to allows investments flow the $XX cash cash expand March in internal the we us year. Cash

$XXX approximately this We of the share an of average repurchase year. at During shares quarter price the an repurchase committed $XXX million this the program $XX.XX. approximately $XXX for third of price Since average we executing have program, at the on of Exelixis shares repurchased $XX.X. we of share million of remain program commencement million to XXXX, Exelixis repurchased fully

guidance full XXXX. turning Finally our year the to financial for

announced presentation are revenue is we we we and the the Given deal expense our in reflect Insilico and where Please Slide increase I'll of R&D in guidance. for QX guidance guidance, are earnings are we year, R&D the see now to the XX detail. call in P.J. tightening SG&A our over increasing to turn The our further expense September.

P. Haley

Chris. you, Thank

quarter franchise. resulted continues at The in RCC, a second-line very execute level, third which in be #X to quarter CABOMETYX prescribed for of high a and XXXX was HCC. has to continuing TKI Team the cabozantinib strong

plus combination first-line in with combination in #X the remains CABOMETYX nivolumab TKI carcinoma. . cell renal Additionally, immuno-oncology

the the perform share patient terms in well terms from XXXX. relative QX perspective. the XX%. QX CABOMETYX business new grew both remains and TRx demand led TKI the market CABOMETYX QX In year-over-year to TRx marketplace and both and again at starts. of XXXX CABOMETYX basket strong, in of Furthermore, competitive in continued to business, volume X%

is plus RCC plus highlight arm, arm nivolumab As as CheckMate full to combination median the competitive, we [indiscernible] first-line RCC. in CABOMETYX quarter the months, was X.XX. be we survival CABOMETYX over CABOMETYX XX follow-up first-line experience plus have ratio the in of improvement representing with comparator with long-term months nivolumab fourth data in was physician overall which and continues a of promote an Positive the extremely hazard QX for market with reinforced discussed the #X nivolumab XX.X the XX-month immuno-oncology previously, XER prescribed TKI plus

that position in leadership the These data fortify RCC marketplace. has the CABOMETYX

data results the in opportunity we cancer approval well tumors. forward, unmet in are in the top the in for metastatic castration-resistant the Both Looking need significant the neuroendocrine coming about X medical positive continued will excited potential with line recent provide and cabinet studies regulatory Contact years. from prostate for trial populations are CABOMETYX patient as growth for pending as

the in discussing R&D our opportunities look cabozantinib Day At December, further franchise. these I X potential to for forward

event to excited assets. commercial our at emerging I'm our perspective share Additionally, on pipeline

that, will and strategy to on informs as experience to value to provide turn impact to the market XBXXX, with Amy. ambition bringing Exelixis. for focus and our XLXXX drugs cabo I'll patients and over pipeline that we areas Our our And with atezolizumab, in call significant

Amy Peterson

Thanks, at how P.J. first to I I be am Exelixis. here want state thrilled to

in targets and sharing and to variety I'm clinical at translational opportunities, R&D platform is for Our and forward pipeline research growth. potential and looking broad, development upcoming into development and capabilities and our of Day. modality representing fruition bringing with of providing a which exciting our progress combined high clinical terms both

will on into our clinical more intent Today, going much in high-level December. pipeline with I the of provide a detail update

in which studies. patients and Let's study XX, XX. and a second top In open-label mature determined randomized begin August, briefly novel independent mCRPC. PFS patients hormonal atezolizumab OS. mCRPC, I'll from cabozantinib study radiology Contact evaluated prostate tumors. atezolizumab with Phase multiple This evaluated [indiscernible]. late in with central neuroendocrine by as or both castration-resistant which endpoints metastatic announced in cabo we and most data plus pancreatic with [indiscernible] cancer, with cabozantinib. therapy, III is of versus line compound, cabozantinib blinded review patients start PFS primary with CatNet, of or or NHT plus Contact our positive extrapancreatic has This

to a event to So inform that endpoint. progression not PSA by was allowed. disease example, PFS restricted disease bone-only not for this nonmeasurable Eligibility only considered was measurable was patients with best is

issued also observed were FDA, signals benefit noting and in release in a favor we trend press [indiscernible] [indiscernible] new of a adverse August, significant favoring safety and No overall In statistically the PFS survival. the on will cabo or OS we from par when events monotherapy. were expected more submission with potential on either from are Based the is results mature. what discuss a atezo feedback regulatory

study results the by Also in with powered study in a we the CABINET, tumors previously in with cohorts, for [indiscernible]. cabozantinib X extra versus The announced [indiscernible], August, patients or the pancreatic neuroendocrine Alliance neuroendocrine conducted from placebo independently in treated oncology. clinical evaluated in tumors X trials positive pancreatic patients III Phase other or

cabozantinib So PFS Jennifer there's Dr. by Data PFS for studies Phase pNET, months X. of was In ESMO ratio recently positive in versus III safety And respectively. signals epNET XX.X the X months were the populations, these and median pNET FDA hazard in-house. once X.X Chen, X.XX really bring with and in the epNET, noting was cabo X.XX presented placebo. at versus we median the were X.X PFS months new to for months X for cabo placebo. for look we forward data identified the discussing results for No and in

turn now will to I zanzalintinib.

are [indiscernible]. triplet evaluating monotherapy, STELLAR-XXX zanzalintinib trials PD-X, and zanzalintinib PD-LX inhibition, also Our with of immune combination Phase anti-PD-X and Zanzalintinib checkpoint XXX Ib/II combination

these from in you expansion a have testing of combinations. As tumors can slide, see multiple we the variety cohorts

will serve durable with patients Indeed, previously and development to being early for with [indiscernible]. responses yet clear on Data expanded for presentation [indiscernible] cohorts cabo shared both kidney promising cancer been as were the data data compelling generated support Cancer are from in these we late-breaking Dr. place in These [indiscernible], oral and Nashville. International Friday, Symposium patients. the by Kidney cabo November abstract accepted at XX pretreated in observed naive taking have cell

metastases, Zanza, in with zanzalintinib enrollment evaluating evaluation Turning metastatic patients non-MSI-high revised nonliver combination non-DMRR in first cancer. the in placebo ITT by with do refractory to [indiscernible] versus not of colorectal This our studies followed patients now liver STELLAR-XXX, study was registrational who outcomes into continues population. the evaluate [indiscernible] plus have to an

STELLAR Zanza III countries. The trial, untreated STELLAR-XXX kidney size PD-LX in pembrolizumab patients plus gear [indiscernible] NLM sample squamous least, is II/III posted or but combination nivolumab carcinoma to patients versus LM Phase cancer, which trial, with enrolling in events both of positive with now activation of adequate And and non-clear just which last not and Phase Xansa clinicaltrials.gov, for full alone and XXX, metastatic in in advanced the and [indiscernible] multiple head number of of previously our compares pembrolizumab the will these evaluate combination site is our cell mode. each metastatic cell into analyses. neck with untreated we are in was

will move to that need. This, patients Given into excited the about may option. with versus Zanza emerging the provide result emerging tolerability believe address has to activity data Zanza the with with of plus We're clinical this development ICI. we and single-agent with broad combined generated and a and chemo-free cabo, program of with rationale Zanza, pembro in data offer profile unmet pembro compelling outcome potential Zanza in combination monotherapy patients favorable improved combination

We design pivotal continue to landscape inform initiation the of evaluate and for studies will treatment Zanza. to the additional

dose now our allow XBXXX, turn project cohorts also are take here different which I'll will determine also into clinical broader at forward serve which antibody combinations and to studies bevacizumab fulfilling tissue payload. in program. us to underway, modified will to registrational the a factor [indiscernible] development the data expansion and incorporates nivolumab X as and and with Combinations best initiated multiple targets We've inform while to with a conjugate, optimists. doses, drug

and also inhibit a believe has all our anticipate obligations transfer and the in a how [indiscernible] are responses be the advance XLXXX, molecule assessing the inhibitor. in that the this this asset best-in-class like We acquired repair with full beyond inhibitors, through about as [indiscernible] dose DNA escalation, of end or of addressable best monotherapy to that urgently BRCA excited agents agents deepen and very towards process of year broaden to damage I'm combination. those Finally, mutation. to damaging but We aggressively DNA not potential this carry recently population to who only both

can despite In our a the Day treatment that, more cabo very to what better flagship robust over from I'll our maximizing benefit progress I'm advances much looking in summary, Dan. about unmet data need presented still we the do molecules optimistic we're need information forward advancing potential asset call December. the to for indications. who, while significant patients pipeline of patients and sharing in our recently options, to and with detailed at I'm about R&D And turn

Dana Aftab

I I All I'm excited for event. of having here focus to and and been quite has her cobimetinib, month, a and what's organization. excited to days about our into we energy saying known I've going start for her on for on team just lot together the right. Thanks, We've working want preparing [indiscernible] time, that working now Amy. store were Day brought off by in next with when R&D to the be my R&D. some am as back Amy in how with working partner

I'm to month. from some to of brief be So what detail what greater highlights discuss in next planning just hear you'll me

[indiscernible] development discovery toward third the toward quarter, IND made solid In [indiscernible] our of we and status. programs progress early existing advancing candidates filings, goals

development which small candidates added We track and which of existing next X file are recently programs pre-IND to new that X from XLXXX, new molecule on be our for to a of be year, INDs will pipeline. we X will biotherapeutics

programs, activities preclinical to X INDs existing year. biotherapeutics next our track For with programs on for we expect file and IND-enabling are

that carries file antibody to payload, mid-XXXX. The be anti-tubulin XTX for first targeted our we the around which drug will XBXXX, cytotoxic conjugate expect

our track XXXX. IND will the for the of targeting factor filing conjugate in NKGXA, with half that for is on will drug program be late the IND which bispecific track PD-LX This XXXX. second antibody on a targets carries payload. for antibody The third for filing is along be inhibitor [indiscernible] XBXXX, in And IND second IND XBXXX, that tissue

XLXXX discovery context we the [indiscernible], ovarian, of in molecule tumors, to mentioned synthetically and internal generated earlier, a a and is PKDX inhibitor increased range of pipeline. I program. was of endometrial is Inhibition including added from PKDX wide of occurs that across small lethal which XLXXX selective So as recently potent our colorectal. an

was to is be designed mid-XXXX. IND and tracking filing best-in-class Our towards molecule around

these end we more our In several to the nominate candidates programs of biotherapeutics this to expect programs, from addition by development discovery year.

immune include We our are pathway currently to conjugates. novel track a targeting on a reach to of X which, candidates stated XLXXX to some up antibody new will antibody new development goal year, addition and in checkpoint this monoclonal drug

patients have of contribute live turn with or longer. mission I'll these of to our best-in-class recover helping stronger first to that, back meaningfully potential the the cancer call represent over approaches and and And to All programs Mike.

Michael Morrissey

Dana. All right. Thanks,

Exelixis our for happy and in forward Exelixis, the you open the of progress call patients questions. We're We we're on all we XXXX history strategies moving a develop Thank We capitalize many our in long Exelixis R&D quickly thanking on cancer the drive our As future. in for latest to updating advance our entire achieve stronger their by heard today, more of and highly mission and on to efforts motivated help team discovery pipeline to urgency efforts commercial our excited support look We and to patients quarter close third our sharing Day The discover of call focus momentum has as is science a you've results on . I'll clear to and the in and cancer team future. forward single collective our the our and for and had and the activities. strong look help you now our quarter. to to December. is every fourth build recover support your to live day to to development interest innovation and our collaboration. longer. with continued

Operator

Instructions]. [Operator

the Your Schmidt first question of comes Guggenheim from Securities. from line Michael

Michael Schmidt

Congrats kidney Could data many them naive. how next here regarding out of just progress. the pipeline How week. we had meeting? coming upcoming on number of in Zanza all the cabo conference of a some And the you be set data patients? XXX I question the expectations interpret just will at terms STELLAR of help should the

could products? you of help clinical will R&D understand any new expect the us data to of upcoming what In particular, there. or secondly, you times, disclose you some a stage clinical Day then pipeline sort again few And the mentioned from just

Michael Morrissey

So Amy, we the all plan second take one. the on first one, and can

go ahead. So

Amy Peterson

the Michael, Yes. Thanks, for question.

around about really cancer emerge we're cell continues kidney the excited can data especially we've because the in the think to on I that just discussed much [indiscernible] Zanza, monotherapy that is is There's presentation simply you received Zanza. embargoed updated XX. November in XX that that the is I give in data patients from clear the of not details and terms the corner around the cohort. data before

on you right So forward at say going with I'm that's Day, to now. R&D about looking that all deeper can I but

Michael Morrissey

Okay.

R&D On the side, again, just day managed expectations.

focus talked data, published for times any about, As do new as science expect and the going we on I think, today, strategy a first. main that and on late-breaking I wouldn't to to investors. our commitment to update we numerous investigators we're have

the see XXXX the pipeline. and success how our frame you'll super compounds. with to the strategy with tactics we've So We're cabo and had we're in for new excited that throughout of moving forward the context our

impact there. seeing everybody an you forward and to we're be actual and looking . will it So day,

Operator

of Gerberry Our from America. Bank the from next of Instructions] Jason [Operator line question comes

Jason Gerberry

I engage you occur with cabo, feel trial Or in settlement? with instances a some counterparty operating talk settlement as a know that settlements engagement you post do lot is as do counterparty -- know more to talks. regarding MSN in with you're my well. unwilling is about any there question a the can't Mike, IP We but

can on So extent appreciate that it. just curious you to the dynamic. I comment

Michael Morrissey

way. Yes, say to Jason, talking thanks can't a the question. this really here. people. -- for lot Again, We're put I like it I'll We

as It's work closely culture, be it's open our collaborators interactive variety in We and with -- very we possible. in DNA of have a as our different to who

-- job be I really So not strong ahead If settlement have week. limiting think be the They in we data, in the go had, how it's rate a to view was we context here, think do. proud into we whole won't right? that. court. had week that legalities the going court. I the super was now super out their being I'm Again, goes of just I get the to a put and to about there to the there's and of hands context, able the and last team of trial, the

right, things happen they But settlement certainly them. we'll happen. if opportunity, engage you're And when there's can a

Operator

Instructions]. [Operator

of the Our Renza Gregory RBC question line from Capital from next comes Markets.

Gregory Renza

on from forward congrats diving pipeline, team, question Mike, to just first you're progress. really Amy and and know and into the I coming Mike we the hearing the R&D Amy, time data a maybe Amy. Day up. and look the for right [indiscernible]

talking wanted here think value give pipeline to pipeline . and portfolio you're realize an order talk the opportunity bit you Just the the about you with the of that are the the ahead to see [indiscernible] opportunities a challenges of about that to and you in some perhaps you also in

Amy Peterson

thanks, All question. appreciate be and welcome. for thanks for right. Greg, Well, really excited the I I'm here. it, to the

reasons development Zanza. of I'm opportunity them of skills about into to particularly and the Exelixis assets develop excited I has -- the to and they these where fully that development. warrant limelight apply development here all into think be skills is the of because my and bringing the the the main excited pipeline to reason more X company's I'm

is share that be the a data And that more we'll that it's think I of class. to R&D best at is again, emerging demonstrating in able Day.

the so profile [indiscernible] think [indiscernible] tissue differentiated our in be factor different tax the ways, from couple different. molecule the payload a is notably I of most in should And and

not in we have USB with just the the to best-in-class I the a mentioned And combination inhibition. that's opportunity with call, And entering X the for we there. example, believe. in seen, inhibitor that's opportunities in PARP as So asset, [indiscernible] only clinic responses

with inhibitor, patients beyond but mutations. those patient to the PARP also population accessible with to who BRCA drive those might broaden benefit so further And improve

in them. there's really opportunities any Exelixis each will the I absolutely hard exciting but future. them, lot a So X for to of on focused of focus of on It's be

Operator

our moment One next for question.

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

Jay Olson

on progress. the Congrats

For might you on And without the sNDA analysis CONTACT and when about you into then this OS talk can your atezo cabo And treatment . setting? happen OS? clinically XX, landscape? And can OS would describe meaningful benefits do the the how modeling. for you based you also, where next particular file PFS fitting see plus in

Michael Morrissey

Amy, question frame -- opportunity So at commercial then then take we can super of level. and let's take the the a that high [indiscernible] first part of kind

Amy Peterson

Yes. appreciate Great. Thanks, Jay. question. I the

based event would sometime XXXX. is we in OS liberty about not So talk at to much I'm driven the that. estimates, on really OS current more believe final occur

As for not the what meaningfulness rather of on just it's PFS data, speculate remind difference going has and PFS, to to totality a patients be, I'm but that patients who clinical into and a of had were visceral disease, included extranodal patients of are disease. must These have measurable liver patients represent disease, study group a very enrolled patients. prognostic that poor with with the this

So commercial of tolerability think ease don't of them. P.J. accessibility I that patients in a and let the about PFS therapy. totality group And I'll talk data, so of to the just available but have delivering with the also it's that, options opportunity. many otherwise and not improvements And the

P. Haley

thanks the Great. Yes. Amy, Thanks, question, and Jay. for

patients. Amy as need think this is medical certainly highlighted, high an I for of area unmet

we've along. from all and heard important, really [indiscernible] that that's So

potentially castration-resistant to majority now, think regimen setting the are second of I the in. about prostate how obviously, NHT NHT. that, this patients obviously, could addresses the study Right you then you've fit an getting first-line got NHT. a And relative beyond patients think metastatic subsequent if chemo and in

So that data. there's

physicians that, in beyond chemo, But we to that really hear patients and it's delay their want consistently something then think, I treatment.

the So these that for really mechanisms a And I this action setting. help could X Also, are in cancer prostate then of chemos potentially novel option setting. think potentially again

a there's time disease in So lot available broadly I no approved think as for in agent, excitement there be a where certainly, this setting certainly for MOAs excitement setting. lot of well. immunotherapy any of new will And a should there's that a get

see and on So I to potentially prior lines the atezo used therapy patient. would of depending think chemo you multiple cabo across

Operator

One moment for our next question.

Our comes the [indiscernible] from next line . from Truist question of

Unknown Analyst

you in know question how recent They second are [indiscernible] very drug Truist. presence. is I line [indiscernible] X RCC, the to a [indiscernible], of This which is strong launch regarding we the do approval view trying of from have where about the impact this [indiscernible].

so do yes, ask differentiate share be and struggle this a capture to other significant how to you So of I do couple want drugs? plan market you, from that you would expect the

Michael Morrissey

P.J., Okay. you that do want Thanks take Amy. question, the one? for to

P. Haley

for assume to at thanks Yes, the I data question. presented Light ESMO. you're Spark referring the recently

certainly that and tivozanib. setting, setting approval TKI We've to in HIF have with with obviously, beyond we who lines of head-to-head was is KOLs at that see of received in didn't benefit. data important So therapy and everolimus. have with having a in competing for And discussions It later contextualize about OS really no I it's really, with the predominantly IO an the realize that, already had think that line And data. lot RCC is likely what very late and ESMO yet inhibitor. that study patients really in a

we the see significant impact So generally don't cabo with our . any business to regards business second or line

Operator

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

Tsan-Yu Hsieh

new Thanks you. and question, congratulations forward Great. Amy to role your working look on taking for with

see first to all, really cancer. IO prostate in pleased containing So the first of regimen positive

there's of field. moving lot in the So pieces a

looking of higher a they along you I lines nature. want the to sounds pertaining FDA the for us what is right? given XX, the of like give can CONTACT detriment there. something no look for It OS, you crossover if crossover. curious sense the guess at bar the Novartis just if to Is that for Just look allows PSMA for [indiscernible] no

one. number that's So

in your market about through OS morning, on view kind navigate And whether [indiscernible] its to to you have within impact evolution that then regarding . line that setting, first curious benefit the this And space, the kind of of GU adjuvant market? plans staying metastatic the

Michael Morrissey

question, first Amy Thanks, Andy, then the adjuvant. have part the and talk lets about or take P.J. can first

Okay. Amy?

Amy Peterson

Yes, sure.

what What with data. other question can't I some say not is it's pretend the that complexity appreciate for. to agency see looking the So are that feedback the say to mature is it. I behind the can actually companies and want just I more they OS and inconsistent getting

keep I'll progresses and that So tuned. posted stay you as

P. Haley

data question. setting, not for time. the adjuvant to as been OS while in that originally the regards study you ago was and on for the speak. presented the Thanks With so hazard market to original XXX impressive, some has ratio, The years know, quite was mature,

no really is surprise. this So

that these data think were I positive.

important I this to nephrectomy the as an small is think year. of study the who get relative by to given that number a patients quite sort remember high-risk population in defined it's

we're working its talking with those the algorithm regards that's patients. few the in And think already So way patients thousand to recurring treatment through setting. I first-line just a been

feel pretty a have we So good that. for

or our Really them we haven't sort in What seen is think patients while date. to do [indiscernible] of patients. positioned after inhibition. that do much so TKI of to a speak, who physicians to obviously, checkpoint of And significant leads many shortly data, first-line pembro a And relatively here them potentially on impact recur adjuvant often pembro setting, the the the totality for those in monotherapy and then well of refractory, consider we're with as to setting.

but analysis. certainly, years And first-line OS, things a of of and now a overall, it more couple but will years kind these setting. develop, that impact with think take in for much we've to really with we comfortable I physicians in pretty that, obviously, see of a don't been significant the few prescribe

Susan Hubbard

P.J. Great. we'll Thank thank Andy, you, and for questions. Operator, next take the question. the you,

Operator

line TD the from Werber of comes from question Cowen. next Our Yaron

Yaron Werber

the know But nice that specifics amount judge and you or My comment which maybe just think be. February some just be? the Does you XX, question of comment just the mean steps decision bit? line has last response the we the decision will And things see a maybe the of would way what how procedurally, understand on give next help did can't the do a us kind time brief briefs judge -- Great. you can in procedurally you on you a give do by time can reply after I case so which it are of on terms little you to understand due has briefs, -- render -- a and you the replies, you generically render that or the initial the outcome job understand timing, that to certain to a then week.

Michael Morrissey

standard Yes, [indiscernible]. Yaron. for looking It's I To details back really transcript he's for he there. exactly like to pretty what to details. normally and refer upon you in nuances keep question. stuff opine and the Thanks transcript the to But I I [indiscernible], the for. in the it's in just me for this it want what's asked A, how expert and wouldn't it hard the not to [indiscernible] in want to It's with be -- stuff just me, see what seemed with the would an what's can get works. I'm the

Operator

Our comes of line question from the next from Tewari Akash Jefferies.

Unknown Analyst

This on for is Amy Akash.

data to better profile durability love Will longer-term efficacy and get can able of show efficacy of one, data? Number cabo, internal upcoming a ones STELLAR-XXX we quick will combo an be we X or looks given generally of here to safety then when the a new from number just cabo And in your on both that revisit it's kind this and to two, for Zanza cabo. Zanza given sense mono data get that half-life. sort Is into expand on to goals We'd we replace indications. line versus compare So Zanza. with for Zanza and it

Amy Peterson

for Thanks question, the Sure. Yes. your I name. like Amy.

expanded different we for not of Day as we're development cabo. should discussions, appreciate durability, excited that that's is [indiscernible] There's about to into certainly proceed and XX, new give support where with able if those and program, R&D data then as assessing only some leverage of the be into at that, to to the but program, to also components the we're be XXX go of where our longer and our the I'll XXX you're enrolled ICS for trials cohorts, not a regard currently development maturing. we the November after the you'll for regulatory support, With to many support number more detail. we'll different indications, indications expand and example, contribution the why are are Zanza think of and presentation doing to support positive, what is on that expanded So see able those I cohorts to to it and

more I what or at regard back pretty cabo. yet Zanza bullish know about to point go into we're but And time give you I P.J. some to in to to we can't this detail, given relative much So probably will be that [indiscernible] replacing able with examples on why good Mike of

Michael Morrissey

indications. that just sensitive I think to therapy, and use [indiscernible] about said of will, we Zanza here if well. for covered types is and you the as to the Zanza indications, goal pretty dimensions as opportunity across Yes, is we're line possible the tumors the big combinations, to previously, here. of the expand that goal different make The Again, as you it talking

have better it's we So more who we therapies cancer late, important et a partners, different lot combination of the think cetera. can different therapy, very across patients that aspiration we need that . early, lines help a

Operator

moment question. next our for One

next of the Tuerkcan Our Securities. from question line comes from Silvan JMP

Silvan Tuerkcan

[indiscernible] on the second meet the next seems on here respect engaging that you look, are on what outcomes the press a the the meet in not quick release. to and filing can OS congrats from the the so as new like threshold. What threshold the comment OS and X FDA the just is populations for XXX, when have you that Amy in the quarter. plans what significance. a I which the COSMIC It And prospects look released the are fact statistical [indiscernible] here? had question OS second did [indiscernible] with Congrats job. Can this that did about different have extrapolate that X trial. not And these we the

Amy Peterson

Mike. Thanks, Silvan. Thanks, Yes.

a Data So not was meet interim in there of threshold the an course, the did statistical conducted release that that quarter. third was we significance. press did

further next really to trial not everybody time. on anticipated provide I'm analysis, at is that this will continue planned able And the which the are so to in that remind point event-based XXXX, precision and in these to just

to And so . say around more have that. really much I don't

Operator

our question. for moment next One

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

Peter Lawson

will you kind the then data include Would new new Mike, pipeline at around data you no around pipeline? the mentioned you releases Day. products. data the lines And Great. time for include of R&D preclinical 'XX for

Michael Morrissey

frame December for a for see, details new the will and share candidates lot the the upcoming clinical digging I into DC was IND data there. Dana and to data the used that lot for and of best Peter, got speaking we think, opportunities all preclinical present certainly candidates that deep, broad the and question to no I meeting, we've yes, and relatively you'll have Thanks, to a for

see frames that to beholder both eyes a out, works as the clinical how Time view. matures, terms durability of in in again, we'll of and how lines. of data it from committed presenting Again, that point that the we're duration is

we're goals really of success patients So helping stay how of molecules in again, how we view deep all a a And we now the together right then and of aspirational for with think really lot that. that on about. strategically standard details I cancer of getting covers tuned going and go that that very and we're aspects these we're [indiscernible] weeds on excited have pulling variety very different about of care presentation to improve the

So forward seeing to looking you there.

Operator

question. One moment for our next

Morgan line next Hung Stanley. Jeff of comes the Our from from question

Lee Hung

. development? XLXXX Is it of you Can best or in else. from what drug-drug greater any confidence interactions you gives it I that talk And appreciate risk other you potency, differentiates lower something provide can selectivity, class? color about can inhibitors what be PKDX in

Dana Aftab

This Sure. Thanks Jeff. is question, for the Dana.

mentioned, to I that best-in-class. we be as XLXXX, We believe say So don't lightly.

to lot to for more that we and a pursued a a will . lot now where that is did not the which say compound. back be competition something developing rationale look tuned right up. presenting data All best-in-class, to data very on a toward compound. stay just we solid Day, is have R&D of But We want I this at second was follow-on really

Operator

for One next question. moment our

comes of next Capital Darout line the Our Etzer question from . Markets. from BMO

Etzer Darout

Great.

of concept Exelixis. on the early the assets at all see have with is concept for wondered I sort assets where I you of proof [indiscernible] in IND potential you laying could out sort But So we clinical the if thank for Phase XXXX, you comment and clinic of maybe of proof [indiscernible] Phase guess, some there. could the could we of sort that potential other where plans of in for trial, compound I, like just see

Amy Peterson

take Thanks, Etzer. that. I'll

database of XBXXX are expansion that those forward. looking developability concept other those partnered I have is do and But and the always proof decisions partnerships of that concept. way make that in So the say I proven data, good of advancing move are are we're with really into our in differentiate some cohorts. its are [indiscernible] is would progress how understanding the and for proof Phase process developability we proof of we I, we'll actively at on assets and

like the to don't You and know drug responses, have the human, a you it's -- if would but you to a see yet it how pivotal actually or get amount move of a how to expansion actually tissue activity, of looks pharmacodynamic marker, These will is pivotal in couple into interesting studies. that doing the into XBXXX we move study. for designed us a or certain cohorts [indiscernible] we something

And of the And responses have so dependent it's the takes cohorts on mature. those and expansion enrolling are long data, when just responses. it we when that they how the for durability

have XXXX. could we some So things in

there. of of [indiscernible] of we then started. I need think in in that's have go for And that transfer see right, and better understanding proof escalation, we'll terms getting And what to inhibitor, developability dose we a we just as through

in head how start that there. understand to I'm might think with this I to is And eligibility move have sort patient think development terms not knowledge will we the into good of our most already likely asset. population agent understanding that that quickly respond us I -- harnessing I'll stop of help we a and full an criteria

Operator

question. next moment One for our

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

Stephen Sloan

as separate curves This didn't clear is the ESMO OS was from On at us. quite Stephen a benefit PFS for though much. that on Two Chris. the showed cabinet, presented data

on I to best-in-class recently that that view asset you in can set. XLXXX inhibitors? that, And that are light, approval competitive package guess data among be speak will confident you regulators that So what you a USPX as how an then could confidence data in-licensed, gives

Michael Morrissey

Okay. Good.

So XXX. Amy, speak [indiscernible] take question and Dana the to can Cabinet then

Amy Peterson

important patients the significant was the It's question, the designed in benefit unblinded progression-free question way bring was study all to observed survival to point were at an over. because for that and Stephen. time was study was crossed allowed the early up that crossover and that Thanks due the Yes. in is

not given have SNF Whether that passes [indiscernible] agency really really where in us for that discussion unmet have. not of need high the disease we'll expectation a observe such there's -- test late them. a is pretty of survival. available this the to for We're or optimistic nothing survival lines else an patients So to is rare setting and

So discussion. we're optimistic. yet have But that initial again, we have to

Michael Morrissey

you Dana, Great. .

Dana Aftab

Yes, thanks for questions, the Stephen.

XXX. Regarding

work ourselves we compound, quite labs our of in-licensed So a with even actually did though that's own that experimental molecule. an bit and

We quite be that have statement to we believe that a set it best-in-class. supports data our

more XLXXX, to Day. planning to detail about R&D so we're I at lot what give said similar And a

for say -- you'll would a we I see lot a the update stay just lot there, more will on more tuned information molecule. get So the

Operator

One moment next for our question.

. Sandler. Our Piper from the line next Catanzaro question comes from of Joe

Joseph Catanzaro

a just Maybe X for quick me.

know So some in some have I you roles. prior experience ADC Amy,

X XBXXX about about you X you programs sequentially? think you how these you have next-gen factor think and ADC in wondering guys the pipeline more to how generally, that the tissue -- just [indiscernible] So maybe maybe develop relative Top and how

Amy Peterson

the for welcome. ADCs. have Hi, Joe, definitely the for thanks experience the very question. some Thanks in much I

a not [indiscernible], tissue are into so to express the and inhibition, that tissue to an factor I regard sensitive orostatin. with it's express molecule factor both to all [indiscernible] take actually antitubulin sensitive tumors tumors think opportunity that to So like are

a the us actually toxicity potentially regard with of net some wider to payload cast allows differentiated we pursue. a to So adding would a might different offer profile. And, tumors that of course,

payload that are what comes that there Time. between similar are from our When there versus but expect are you [indiscernible], [indiscernible] MMA, other similar, example, the toxicities to toxicities aren't and certain for it as might

ours. not So bleeding to that something is we would neuropathy and see expect with

different We're profile. that that XBXXX profile. forward think excited is and we a shown, is [indiscernible]. an what toxicity already about into differentiated starting our how [indiscernible] us about the data payload opportunity for that XBXXX our We're offers the to have might leveraging than toxicity has So space, bring to with differentiated

question. your hope I that So answered

Operator

One moment our question. for next

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

Stephen Willey

Just a couple of for me. quick clinical ones

X the of quick LEAP kind So And setting you that's to on expansion Joe's maybe question. your you're then follow-up [indiscernible] the just combining curious [indiscernible] head just cohorts, some right the ago. months I the leading being to just and didn't of radar know given guess now? of trial curious. and not Merck of on why around of I'm overlapping curious guess, I STELLAR any know XXX, how within and hit combination And I Just concern think about of a endpoint, announced the its for Zanza risk? [indiscernible], of I couple looking kind part just kind a as relative of neck. not at differentiation cervical

Michael Morrissey

Okay.

misconnection. maybe that second first, just the clear question [indiscernible] up Let's all to

Amy Peterson

Yes.

our cohorts expanded [indiscernible]. in list is cancer for cervical that So of

and Phase favorably months. their a ORR where we XX the PFS patients which of absolutely and And showed didn't XXX, are a what that even it. then to data had of that to a II, regard was with We XX.X the was think confidence is the XX% that, in an in investing in [indiscernible] of mark We though X.X STELLAR [indiscernible] us benchmarks quite what of hit response with XX% gives study [indiscernible] PFS generated months. rate

cabo better bringing cabo have [indiscernible]. is which be So was different [indiscernible], this than cross-trial in to what [indiscernible] that what [indiscernible] forward and with could and -- what be a we looks best-in-class we're is comparisons than we're is we better already believe observed to

hope I that it. answers So

Operator

One next question. moment our for

Our Partners. of next the [indiscernible] from line from comes Leerink question

Unknown Analyst

Guys, questions. the thanks for

to be the during that mentioned you So focused it's lot Day, R&D science. a going on the

[indiscernible] in-licensed, of terms CDKX, on that for quick just And can there's X when the to second of see you if assets question. a us color you pipeline that? in of wondering data like Just give in expect anything recently some these USP any terms we then can

development, guys business in would are assets that as looking of you are the stage terms on at clinical guys In consider you clinical earlier the looking are well? Or later guys stage? in -- to something you

Michael Morrissey

both My Yes. Thanks question. for the Starting the questions, with comments Chris. [indiscernible] questions. for

for So both early and a have be stage, we're and be that clinical be Again, the mid-stage the for competitive stage very to conviction -- that's can right looking or differentiation, that we at looking again, late. help we early, the only have we're look, able either us patients can to have way we're are commercial value that late that to data potentially potential molecules that understand clinical partnering of very the really what for interested right? that marketplace. [indiscernible], be build to and First, going have stage needle because, acquiring . can move very, the the assets in level this

handle in time In weeds probably terms all know of advisable right I getting lines, the R&D Day isn't we that there December. in and now.

and it to a great think will forward there. having looking I everybody morning, be

aspirational everybody patients going we're really So and to to we with science cancer. frame the large with goals going details help where the see these to we're how able can help be to the strategy, [indiscernible]

Operator

questions. this Thank there time, no At further you. are

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

Susan Hubbard

reach follow-up to or right everybody, don't for Thank for today. Certainly, out away. us have you, and me to you hesitate get back . thanks, We'll questions, you joining Yes. [indiscernible]. if to any

Operator

today's participating. call. for Thank concludes you conference This

disconnect. now may You

Exelixis (EXEL) 1 Nov 232023 Q3 Earnings call transcript