EXEL - Earnings call transcript Q1 2024

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Operator

Good day, ladies and gentlemen, and welcome to Exelixis First Quarter 2024 Financial Results Conference Call. My name is Towanda, and I will be your operator 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, Mr. Varant Shirvanian, Director of Investor Relations. proceed. Please

Varant Shirvanian

Thank XXXX joining . Financial Towanda. Exelixis' for all Quarter First Results you you, us for the Thank Conference Call.

ended me first Medical Chief who our are XX, CEO; call President Scientific of March Haley, on Officer, our Peterson, Vice quarter Dana Joining and our progress Aftab, Amy President Chief Chief our Michael Executive review Chris and Officer; for together Financial Morrissey, our XXXX will Commercial; the P. Officer; J. XXXX. Senner, today's our

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

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

the I'll Mike. call over that, to turn With

Michael Morrissey

U.S. to is call revenue a XXXX and on our We're thanks quarter see right. had everyone shareholders the growth to All and to Cabo, business. for the globally. by strong Zanza us in patients move first [indiscernible] Exelixis of of . Top of cancer. a and is advancing improve needle Thanks, the for in our to today. for to exciting care components joining and and Franchise patients productive off priority pleased the Varant, and standard all start rest the demand for across pipeline with company's both the

of cover first it quarter growth saw to XXXX have revenue will to today, we key right the and the highlights XXXX. of a We strong jump the with performance for first, business demand let's with Cabozantinib year-over-year first in compared into quarter, in including: continued the of so quarter

that further TKI as its Even first-line RCC both magnified leading with the CABOMETYX segment. typical in were seasonal the implementation by IRA, the status maintained the TKI I-O market, of headwinds monotherapy the for second-line

X% to Cabozantinib product revenues compared and approximately year-over-year franchise revenues first XXXX. net XXXX as year-over-year in first a leading cabozantinib role First XXXX. first generated quarter XXXX, net quarter franchise partners its its of to highlighting global product quarter quarter Exelixis worldwide by TKI, the grew compared grew X%

remarks. shortly. financial discussed results the full with the and his the growth on additional horizon we're about our indications will that Amy quarter XXXX for As first previously, potential new Cabo discuss P.J. will excited in Chris prepared review

continue of preclinical we our clinical all across development. industry-leading stages pipeline advance and Second, to

and expansion existing focus lethality development remains with momentum for new expedite us, synthetic both generate Zanza the a for priorities top XXXX to XPXXX and indications CRPC potential NET trials Cabo in space. advance Our combination as metastatic clear well strategies. pivotal potential continues clinical new exciting are as and for new and XLXXX to cohort

targeting development, advancing to evolve in progress and expect next and an preclinical solid tumor we range IND which a pipeline years. quickly Finally, our we're the molecules both that thrilled biotherapeutics, of with candidates small of over new comprise indications discovery several in

February, Third, ruling final ANDA first reply of briefs in for to in were and submitted ] XXXX. the a expect continue we MSN second the half [ trial

specifics Cabo While will we will this to patients of a cancer. cabozantinib today, differentiated our on behalf the we company protect other rights vigorously for not with our property the remains milestone franchise. speak respect to any and Exelixis pursue molecules critical continue intellectual with to and

ramp gain to outcome we clarity fourth, the expect up significantly on patent litigation. business we Finally, development of activities the as

to endeavors. in to exploring arrangements prior other options we're combination manner Cabozantinib and similar our checkpoint sharing compound a Importantly, collaborate with cost organizations in

competitive In lens addition, through Cabozantinib oncology-focused fit GI reviewing assets level and and commercialization GU into platform. additional that development later-stage identify are to drug carefully believe enterprise-wide unique our our the we landscape an on we

with for and our in results extensive financial first that, So release see press please an an of hour issued quarter. XXXX quarter ago key corporate achieved our milestones the list

Chris. to over call the turn now I'll

Christopher Senner

Thanks, Mike.

start calendar hole in the revenues of due have of quarter and the at company moving net approximately in expenses first $XXX many Cabozantinib quarter gross quarter Cabozantinib with patients to XXXX total D we million. Part experienced line Historically, franchise net This in than was of XXXX trial clinical fourth franchise in our to PHS year, and Medicare For approximately . Gross million in product deductions Part of the related revenues but the higher Part the quarter primarily product increase D of is included the to year. included to $XXX.X XX.X%, higher which the sales. higher Medicare $X first of net gross in XXXX, expenses. the we first were D experienced which overall, the the million of is to for reported net in net the the XXXX, $XXX.X first of expectations. quarter revenues million. through donut CABOMETYX

trade the of fourth hand. when approximately to of on inventory approximately quarter by XXX Our CABOMETYX weeks units decreased compared XXXX X.X

we approximately units XXXX that and a call, earnings observed fourth had drawdown As we trade January. in conference inventory an fourth of the quarter in experienced I X,XXX mentioned of inventory build on quarter our

is This Exelixis quarter than higher discussed previously, XXXX. offset more price by to of took first increase X, increase deductions on As a the the net January X.X% during price gross XXXX.

while provide revenue revenue Also, see quarter seasonality guidance, where net year. historically we been in product first some quarterly product have than revenues following net we trends, a do in quarters don't lower the

you X net preparing into those to many year, are If product billion first of net net net guidance annual the annual our today's XX% same years, revenue revenues. this account We quarter product revenue annual the $X.XX of analyze the our the $X.XX reported net billion, compare on first them reiterating range the in in when XX% revenues which product last to took of years to and of product quarter are of revenues seasonality of impact call. product we

we As quarters, continue quarters. a reminder, clinical this in choppy been sales future and expect trial to between have historically

$XX approximately in their included their including approximately also incident $XX earned revenues territories. royalty Cabozantinib Total Takeda million sales revenues, in on million of [ of collaboration ] from

first XXXX cost a In expenses lower fourth count head Our million expenses, first excluding restructuring quarter drug approximately the include which XXXX. charges the of of FTEs. compared we costs. XXXX. the restructuring impairment expenses asset the administrative in which was total $XX the of contract restructuring employee-related driven announced general reduction and XXXX, by severance of The of this quarter decrease operating million. January The approximately primarily XXXX sequential operating million -- total for in in in discovery and we these and our and included $XXX which $XXX were of of first XXX to termination quarter quarter were business, costs,

Provision XXXX. reported quarter for the The million taxes quarter diluted for income $XX of company on quarter million company or non-GAAP of $XX income The first for $X.XX fully on a $XX basis. $XX approximately of for approximately approximately a share or a the million per $X.XX net to share for income reported income GAAP first of basis XXXX. the million, XXXX was taxes per diluted also approximately compared fourth provision net of fully

the compensation expense XXXX, approximately income and net of the million effect. net tax the billion. Non-GAAP $XX approximately ] [ investments of XX, income March ended of impact $X.X excludes related quarter was stock-based for Cash

XXXX, at million the $XXX billion committed million fully January of average XXXX. share first repurchase an XXXX the return price on announced repurchase and program $XX.X. XXXX. Combining $X the remain the program, $XXX of we to shares of approximately shareholders will repurchased by Exelixis XXXX quarter end executing share to in of We During we our we

year operations by supported our to activities of level million XXXX guidance, business ongoing of share to presentation. allows our XX from earnings pipeline Exelixis flexibility shareholders and our internal R&D on us investments invest with flow expand we finally, development through to And full opportunities to capital are is program. in Slide external to the which reiterating repurchase provides our pursue cash our and $XXX return financial cash our This detailed

And with turn over to the P.J. that, I'll call

P. Haley

Thank the second-line be TKI . a you, team #X In RCC prescribed the has continuing to execute level, quarter HCC. Chris. at XXXX, high continued to in of resulted first CABOMETYX in and which

Additionally, prescriptions, X% the #X volume CABOMETYX first-line in TKI regards plus CABOMETYX was XXXX. TKI renal combination with In TRx to same nivolumab basket QX flat. IO remains the year-over-year carcinoma. the relative QX grew to XXXX market in With period, cell combination in

a and continued well new in first Furthermore, strong, led CABOMETYX the from of remains share perspective. both XX%. TKI perform the terms TRx and marketplace in at basket competitive business market demand quarter again both CABOMETYX the in patient to starts.

market QX the combination sixth discussed remain in RCC. the previously, we As first-line have first-line quarter prescribed And TKI full competitive. was plus extremely plus the which IO nivolumab, CABOMETYX in #X is RCC

with to data leadership X study was in the GU now CABOMETYX presented year of follow-up, from this CheckMate has and that ASCO the the RCC at long-term marketplace. continues minimum -XER Furthermore, position years reinforce a

in is in prostate Looking trial forward, trial tumors Cabinet X team about in castration-resistant from as metastatic positive Which Amy as some the discuss CONTACT detail. will commercial neuroendocrine the the cancer. excited results the well

are in plus in net agent for oral in drug-treatable need a Neuroendocrine only patients and tumors second-line therapy. oral an an therapy for incident annually approval There There options has new have options options comprise been a patient and heterogeneous sunitinib large The unmet treatment The limited. XXXX. population. X,XXX approximately the become metastatic everolimus U.S. not there is strong patients who become on the progressed and U.S. in are progress systemic for and patients

of being XX% are percentage in receive relative will nature tumors. due SSTR these net of with the to is XX% of Most lines the Approximately patients to part that many negative. more disease higher lung indolent negative. solid in SSTR nets, other patients therapy, And to XX%

therapies second-line the plus this in research, XX% setting. of the reveals preliminary market We account in for approximately oral have conducted market that which utilization

need, or negative had previously and The as prostate lung the patients. a population, patient wish position a a particularly castration-resistant and a patients Cabinet significant market for where net study would to approval radioligand well therapeutic with options broad patients. and significant who range pancreatic, positive as in patients Regulatory including chemotherapy pancreatic Lutathera. of cabinet unmet cancer extra large hormonal unmet an need therapy is remain help on diverse chemotherapy. this medical SSTR with There is net [ to NHT ] for treated potentially Metastatic progressing novel Cabo therapy. population, delay primary

Cabo of patients Many a CRPC in administration novel metastatic and resistant. setting. of mechanisms they with convenient potential NHT these plus metastatic many patients and option an for become Atezo receive the represents before action castrate

a infrastructure organization would in indication. the be to leverage Furthermore, RCC team positioned achieve GU synergy commercial to the new well oncology

provide in that opportunity the look in commercial continued another the In progress approval summary, in need, patients cancer. the growth would years. CABOMETYX indications we team the about I would pipeline help as with the regulatory to is having additional also significant unmet with particularly for Zanzalintinib for these product excited to add forward extremely coming

to that, I call turn over will With the Amy.

Amy Peterson

a high-level focus of highlighted well The the is franchise laser clinical update for the for stage clinical during pipeline. on our as momentum our Thanks, our programs provide continuing Day across last December, the all with P.J. as pipeline. Cabozantinib on execution Today, we I'll team R&D

development share modalities of regulatory trials and submissions and Cabozatinib. translational development robust we variety terms the opportunities, and . with in making potential progress the targets, our of representing growth. for for both a which high platform on combined broad, across are potential clinical our provide an and towards is pipeline I'll on our Our development Today, executing pipeline exciting capabilities clinical

Phase metastatic a oncology conducted let's Chan by XXXX. clinical evaluated ] or trials at with study was So I'll neuroendocrine and and Dr. tumors, which in III EPNET, Jennifer in the to refer with is data Cabozantinib CABINET was start respectively. extrapancreatic which Alliance [ cabo patients as by ESMO for matched The placebo PNET presented that pancreatic treated or study , advanced previously versus or

for cohorts, one strongly and X study consistent Cabo EPNET data cohort Notably, had in radiology PFS on PNET EPNET. profile and ]. favored the was with new for safety independently and of the The [ X.XX hazard identified. no powered the limited analysis for PNET ratio rates each independent The committee monotherapy was populations, available or X.XX hazard other respectively. with its of This profile the blinded safety BIRC signals known initial with local assessments from Cabo based were and

file this BIRC year recommendation from compelling the cross enrollment, our placebo be Cabozatinib. The to an will and in unblind a by and support final the Alliance to IDMC study over ] to stop results months. at intention to allow and decision shared analysis later The [ coming triggered conference patients

his potential impressive with options. support neuroendocrine cabinet data new effective to in are a Cabo The in we population PJ that the in treatment as about approved bring robust and of is very patients dire are quite care As of a mentioned need excited potential cabozantinib tumors. section, have to and standard

to CONTACT-XX. now Turning

Phase had second intent a coming open-label the a We to extra TAVO endpoints Remember, by randomized cancer unique dual the to risk prostate the NHT study given in with patients support III we therapy, analysis to favorable for the of Contact BIRC study from novel of deliberately robust primary file. or plus OS data which chose in OS. patients having assessment PFS hormonal disease. castration-resistant PFS measurable Atezolizumab final this this anticipate measurable our tissue Our is and believe population, BIRC. study and versus and benefit soft pelvic by a ensure requirement We disease, months. of

point results hit endpoints. hazard GU. Dr. prespecified study with the equal considered Agarwal it So to to PFS Niraj at primary PFS means on standpoint, what that one presented we of be ASCO have was mean X.XX robust the dual from for population does significant a PFS in statistical value a end only positive p the X.XXXX. The and a rate to a

hence significant, a study. positive statistically So

nearly PFS rates, is PFS the Berk. Atezo. were curves with was A imaging also was At patients notably population includes by both and the PFS assessed BIRC median in in poorest [ identical ] ITT for bone the already liver according in that This metastases subgroups, to PCWGX [indiscernible]. the and The OS also with observed by patients hazard a benefit population. received who've to favoring and which PFS all an Kaplan-Meier those true in in and Cabo demonstrated outcome that NHT this analysis, criteria, trend

demonstrated typically second higher are which CONTACT-XX and prognosis, Cabo aggressive is limited not enrolled NHT in for already given second and The agent by the One that NHTs profile reflected tolerance reported prior of other CONTACT-XX. having consistent and surprising, highlighted remember, toxicities of The known NHT uniquely the subset those year those the duration this doublet with is Atezo activity from with median profile with studies. was in mCRPC. the have to very was worst Cabo NHT. tolerability clinical each were Especially who of Atezo X is monotherapy the a well plus good with NHT tolerability with tolerated. than prior

approved other with as well combinations. IO-TKI As

the in from believe GU risk advocacy firmly year. acceptable on from we represent filing committed Putting and findings the and patient patients we groups benefit to oncology received this we've many profile, are based and an input together community, this these

to in excitement XXXX, of lot with I'm to our a where to going turn excitement now quite grow. but Zanzalitinib there's Cabo continues So

and IKCS presented observed Data development the Conference and I variety with of clear data year, treatment-refractory promising responses Pal patients will expansion continue generated a have these and R&D with Day and from At cancer. tumors our combinations. has Zanza. cohorts in last support cell to Phase for compelling cohorts Zanza expanded Monty Dr. multiple where in Our were monotherapy, XX durable studies kidney

of who are prior VEGFR received Cabo. of and TKIs whom majority previously XX% whom XX% All prior have the received received had including IO

in had XX% detail shares but prior and profile cabo of who a ITT that kinase especially are in cabo XX% the potentially very will into differential more received tolerability and tissue, including encouraging, about Zanza ORRs half-life, target Dana of in and hear patients profile. emerging which in partitioning tissues, activity to given the which shorter result The explaining from differentiated you tumor seems the

receptive discussions at not collaboration to Zanza's the ITCS community the about The Geo We're presented was only very and ones around are opportunities ongoing. excited data potential.

Turning currently pivotal other we're for and now with opportunities companies. including studies Zanza, III have additional X pivotal to collaboration our evaluating with Phase studies, studies. We

This Our metastatic patients and of most Zanza atezolizumab study cancer. with colorectal the non-MSI-high STELLAR-XXX. mature Plus combination versus is in regorafenib will evaluate refractory study non-DMMR

The population significant. NLM, evaluation mets or is in the primary of patients endpoint should in of statistically NLM population in the followed without by liver OS an be OS population ITT the OS

combination, the liver is mets So adequate endpoint. and is of about liver be especially months. complete. not cohort in resulted has coming each complete to dual in these for events the in should in number have and the NLM LM this of met tapped without The rapid patients both cohort this ensure enrollment of uptick PI potential patients NLM sample to size to Enrollment a basically the primary enrollment excitement in analyses.

This STELLAR of overall III to nivolumab with of patients our progression-free has cell primary compares and survival points dual XXX nonclear OS in is secondary untreated endpoint. metastatic which cancer. previously Phase the is a sunitinib end rate. trial, plus combination Zanza kidney response

a lever consider is prioritize of how to key we when portfolio. success strategic of probability a The our study

kidney enrollment a study this we that a and potential beats ]. cancer are kidney TKI-IO [indiscernible] countries. multiple excited combos cancer for VEGFR-TKI in Zanza that and kidney work believe reasonably about has best-in-class Given in PTF has non-clear this cell work a cell monotherapy high ongoing [ in that also Investigators that is Cabo VEGFR-TKIs cancer nonclear in combination

is of our expressing the head II/III combination Zanzolitinib PD-LX with or Pembrolizumab in carcinoma with and Phase cell metastatic in advanced STELLAR-XXX trial, Pembrolizumab versus will patients neck. which untreated alone evaluate squamous

This study activation was site last mode. activated are late ahead steam we full year, and into

mechanism to emerging permissive that has Zanza profile an could Pembro believe Given results chemo-free in we versus tolerability option. environment, combination of this and and of its Pembro plus outcomes Zanza the result of the a potential immune in and activity single-agent favorable improved offer patients action

we data. or as the to make did we modifications will course, LEAD-XXX And increase with are to by success. Of probability STELLAR-XXX STELLAR-XXX just intrigued necessary appropriate of the

our We design we evaluating from Cabo data emerging transfer are patients best-in-class believe treatment and inform commensurate competitors and An studies asset the for and the ultimately evolving next VEGFR-TKI that landscape from potential value for always the initiation activity for of Zanza of improved as shareholders. with Zama. studies data has pivotal into that our to in

clinical passing I'll as data on statin a before a study cohort conjugate into will now factor briefly incorporating a matures expansions to XBXXX is initial the over benefit our robust directed the tissue modified the the in to and touch JEWEL-XXX Dana. pipeline drug risk as profile. our antibody payload. or XLXXX call the understand is early and Enrollment allow us assets, XBXXX

have provide updates will We maturity. when data we

we USPX not inhibitor. certainly this particular will and excited is XLXXX, very last talk more Finally, on why optimistic are about Dana remain we least, about. which

state with cohorts time, I'll hope are inhibition just and cohorts enrolling, So PARP year. interest combination little escalation that later a this to open of the dose in we

of We in molecules, despite advancing options. better In treatment our stage flagship patients we we're a asset, summary, benefit can for very from high patients optimistic still medical maximizing to who, the what significant advances need indications. unmet need remain potential Cabozantinib, do clinical robust about while pipeline

the And to that, call over I'll Dana. with turn

Dana Aftab

inhibitor, Today, giving XXXX then inhibitors, Thanks, USPX preclinical status. of a our for Amy, candidate goals preparing with next-generation wrap progress Zanzalintinib. update toward afternoon, everyone. and and our XLXXX, our compounds some I'll new the receptor on And for IND on good updates I'm up VEGF to filings and in brief tyrosine advancing kinase development our quarter first for

are good making this are we X on our all to of on front, progress to pre-IND IND the programs up track file year. and On

to IND to our payload is The XTX the year expect wrapping first cytotoxic we one that antibody-drug for one we carries MMAE. around file XBXXX, preparation expect this that antitubulant so file is midyear. up conjugate soon, targeted

to in MIT a one small one this is of we a second expect [ molecule the this for synthetic also The and PK which inhibitor which levels, IND lethality on increased file cyclin that to track range is is around of across IND shows year progressing, E ] context are we tumors. of file occurs mid-XXXX. preparation wide XLXXX,

we in to and fourth antibody activity for track complete bispecific for XBXXX, The that and displays in study have and along third our for activities cell GLP NK tox models. XPXXX PD-LX expect this the us file will manufacturing NKGXA IND with IND year be quarter targets other preclinical XXXX. is on filing The now engager of

programs a the Each rationale these for data of generating clinic. in has differentiating solid

to and get get and quickly. we're enrolling trials INDs So the excited these filed to up

is development candidates molecule potential achieve our PLK or conjugate to new X clinic. year, best-in-class generate we of novel to drug with programs first synthetically a represent approaches programs, in which at In of a are on the least year. of some and TRiMXX these program. this goals including small new with differentiating exciting cells currently track targeting inhibitor amplified lethal Both X, terms of and results this antibody

pipeline additional pleased this certainly year. we're that putting remain on we So preclinical into track assets the these for

comparing shift brief first I'd our preclinical of and I'll start data describe describe for with in So some Zanzolitinib small now some like we a a molecules bit update we've XLXXX clinical generated the and generated Cabozatinib. data and to on gears then exciting preclinical X pipeline.

the strong BRCA in in compounds after the doses cancer preclinical persisted at PARP tumor a for in growth that inhibitor, data of with ceased. dosing The xenograft mutated. least the recently alone the which the tested generated X combination PARP in -- in showed resulted that is the select given selective very we MDA-MBXXX month has both regression model, with breast tumor XLXXX gene showed combination delay combination of when We at that minimal serupirib

shed data to I will other be improved Zanzolitinib for more sharing basis benefit risk emerging think, to on Cabozatinib. underlying to compared light the I'm The that help for appears with an you today, profile

but recall a appears optimal Cabo to that's may who improved Amy, as as overall be seeing dose that responses retains tolerability. with kinase profile You what PK and patients target with on certain an profile more to for you diarrhea with some cabozantinib zamzolitinib from of progressed adjusting risk rates the of benefit we're heard lower Zanza such profile manage And fatigue. hand-foot in syndrome, AEs and with Zanza just

We now differences the have preclinical molecules. between explain we X data, some which help to think these

the First, in profiles in the we've biological Institute. Prism explore both a experiment differences to side in the the compounds, side at by same were and continued screen [ recently target Broad run ] of potential

showed compounds that were This key their target Cabo the cell viability, back representing essentially large-scale compounds got XXX and largely approximately screen of impact screen Zanza cell subtypes. a hypothesis the on is remarkably diverse are the the biological the answer in we distinct same. XX viability The confirms cancer that lines, cell line terms which to profiles from of over the of cell across ability effects results similar determines

rats These the between MET inhibition when This for concentrations Cabozantinib, as improved potent profile normal activity partitioning free and observed were tumors that be in rationale more might with apparently to differentials drug to differences similar free target in are hypothesized the had bit seeing normal profile compared in in tissue surprising mice a such Zanzalintinib I tissue the between think emerging concentrations we for results explain translated potential to consistent the Zanza we lower benefit and not Zanza. improved molecules tumors clinic drug in clinic. help Given and in Therefore, expected by as a compared these with with the that we're concentrations on-target related risk tissue in Cabo. we profile, both the but distribution of X certainly and healthy drug and studies tumors tissues. showed tissue in results conducted Zanza higher to

call So with the Mike. over to turn that, I'll back

Michael Morrissey

executives I will Thanks, retiring highlighting right. X Exelixis company for nearly after All long-standing Dana. X are close serving decades. the our by

First, organization. Exelixis And of discovery . efforts Lamb, the years. our Scientific an his impact outsized for on XX tenure EVP strategy made was you during nearly with as all Peter know, at drug

nearly Laura team, of we to Resources, the Dillard, leading spent our On HR years are Additionally, ensure pace behalf our of and the company. XX Human Exelixis EVP growth entire keeping with efforts of the I'd Laura for to commitment on We dedication their importantly, and start like global their as both to most Peter them retirement. thank Exelixis patients best a to and they the friendship, level. cancer wish evolution all

to start efforts thank I support patients be that, entire year science their hope and Exelixis our for with great critical this the in a So in the serve for development future. activities. expect our the and team want to to XXXX to discovery and we commercial We're to off

Exelixis cancer We patients team and mission longer. help hour live small built expectations of and do to every to every recover that a and highly Exelixis motivated are exceed stronger as we our company constantly big with fortifying The all day. is

on Exelixis, in We your thank for and continued updating forward progress you questions. you and look and our for to to future, interest support the the now we're call open in happy

Operator

[Operator Instructions].

question with comes of line first Pipa the Our Sandler. Joe from Catanzaro

Joseph Catanzaro

here. the taking time appreciate I you

later-stage of wondering your I'm in to sort for and a looking patent in the GU, how regards if clarity events comments MSN outcome around earlier in think you revenue you the GI, elaborate execute Is could oncology. and So sort guess, litigation with of of positive do a modality assets interested bit stage? I Cabo could with later you what the define this deal balance you would agnostic? size And on tail? sheet

Michael Morrissey

implementing earlier year to on it's modalities We collaborate either collaborations new us helping focusing this of in the focus sharing Yes, in Zanza as or arrangements. the efforts Mike. on as and are compound other Thanks with of trials the talked question. entering on isn't restructuring were our BD cost about as well that pivotal a Joe, this we assets really Yes, pipeline for our find molecules approach. later-stage new in their terms and/or in in terms

and in We we're and whether interested a discovery, lot look, development overall a think great of to fit enter. So, in got are go organization we pivotal well a they forward. commercial already very value pipeline. approach, be building we can trials about add into We've as late-stage that assets

molecules So on wouldn't wouldn't and to want in individual terms size, small We're certainly to on want comment targets. of agnostic modality comment I and biologics.

compounds. eye the December. good Day really at have, R&D that data We informs you about I will, lens, and in think, good We very Cabo a if Again, back for that. good talked

So we're be of terms our potential in, forward. assets as to to all able will pipeline bring that we into in continue go and finding

Operator

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

Jason Gerberry

my commercial guys you just key that on wanted I indication slide. up So follow think the how an to could like opportunity I'm ramp. curious -- any just

number. that to or the at The seeing about your just second wasn't wonder need creates or like if about launches a Checkmate versus line barrier decent-sized head-to-head of we're educate given potentially them against incidence a I retrain -XER physicians availability just data. studied slow established the is TKI, launch might the all to oral which an the accustomed --

P. Haley

really excited on. Yes. Thanks we're for into is say detail I'd a question. the data Jason, went that more this the P.J. little Amy about

at certainly mentioned, lot a data. what the research. boards. I I for level high conducted We've say some had of of is I'd kind advisory a enthusiasm there's market As guess some we've preliminary

anything prior significantly there'll launches. I different don't think than be

of kind per mentioned or You uptake se. trajectory or terms XER retraining sort in of physicians of

and think very even setting. TKIs I comfortable, they're obviously, with this in

is receive approval. should really this think we a nice opportunity potentially So we

think looking tumors, population that is which in I Lutathera for lot study the that bit I other origin, for studied a the well For be which regards extra the setting. weren't in a to, and broad the was I some a SSTR patients having as to which fact kind of think, with studied who modern to studied broad well pancreatic, pancreatic, potential including data as new negative as as sense, from very of something as set, site different lung, spoke gives the of oncologists broadly little with really agents, were of us included as Cabo, a user-friendly this in positive before really are treated

Operator

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

Michael Schmidt

on Amy for one had I STELLARXXX.

-- to from in or feel may presented And the wondering positive that on trend, demonstrating so degree study overall recently? which not you a LEAP-XX. was to your need criteria what adjust what the compared to in survival And based you level the is data was in obviously LEAP-XX that And confidence how like KEYNOTE-XXX case the trial just Lead-XX. enrollment the

Amy Peterson

And was actually It a to that didn't. to earlier favored Michael. Yes. the LEAP-XX. the OS with the Thanks the for that an terms from get PFS monotherapy the final [ Notably a ] chance presentation an very PEM year doublet. interesting Len ORR of duration -- an and see results interesting of question, in but this PEM, favored response over

uncover a to we're to a population, interested in neck receive aggregated head have Around patient's dose is bit trying reductions dose much a patient and may as the frontline can. of this how we ability other full and frail, that populations. the than So Len, Pembro different as much dose. little And more

regard that we the make context be, understand if trying a you with XXX -- in of will. the deeply patient dose So study are to change frailer very to if and population, a to need

Zanza family. immune the will, inhibit does there's differentiation and between is Which kinase Zanza I in a Len TAM in favoring that environment. you think if an permissive implicated, that

that have because very of is it And a of outcome mechanism the Zanza of and we likely action So from believe Len. will. could different differential

ultimately keep those you part criteria for eligibility we are on changes the posted needs see need as to will. the posted update, make Right we'll what be So on they're where clinicaltrials.gov. how And and changed most made. to we'll an now, we --

Operator

Next question comes from Renza the Markets. of with Gregory RBC line Capital

Gregory Renza

what be you potential pass as just space opportunity? about a and that development neuroendocrine if [indiscernible] indication. have. potentially wondering respect Zanza Zanza maybe there you I there I'm Mike, think you this to building in But Zanza something combos could optionality the context bit therapy explore? you white about about opportunity, nicely combo little in to to are a and certainly Cabo. mean as And tumor the think with the bit is do just on ask would comment the and

Michael Morrissey

a over opine question. one. and punt P.J. the upon, Yes, great . thanks Amy? It's can for Greg, to I to Amy

Amy Peterson

sure. Yes,

next call, things what about thing are for at mentioned I think all assessment. Zanzalintinib. our always the assessing we're that during the As is look to We best strategic in

I'll evolving I P.J. the . And the and us value and and competitive as bit the little conduct for tumor would study about time and the to interested that the big I talked say for well takes on list is Zanza So a are probability commercial. consider the very of success. one it. we in let technical neuroendocrine as landscape on comment high the proposition. That's it to a

P. Haley

if need, at I level, large therapy being mentioned, I XXXX. Yes. of not many kind a back a medical high the therapies, here, as any to certainly, go since opportunity approved new oral with just really is think mean unmet I I

in of I on room and tumor The in plus orals, of XX% line my So population. remarks second approximately the this slide particular. I to lot think maneuver there's a the as type, account mentioned, in for

this think if line-plus have year, at Lutathera, Basically data. second for ASCO you a that. $XXX GI which predate about doing revenue example, the revenue in kind million but NETR-X they is annually. So those of population, over

a of XX% significant opportunity in that's So than market. less that pretty

opportunity big So to this really an new for I over space for is high there's this new time. a grow think for trials really a -- appetite market and that's therapies

exciting. very So I as see it

Michael Morrissey

Yes, that's would just I great, P.J. add.

about even We go between talked And Zanza. the with we similar XXXX, though the similarities with we're in different forward NET the about RCC think and way time. XXXX opportunities saw NET the really X, data very ] back what we obviously the [ here, there's to is lots cabinet to think different XXXX, I indications. of and certainly excited they're

about other We combinations. forward. to invest opportunities hope with Lots potential So as we're we and of Zanza go this. more excited

tuned. stay So

in As . that evolves, keep loop. the we'll you

Operator

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

Unknown Analyst

market for Maybe Joyce is Yaron. This NET on opportunity. just another follow-up on the

you is said think of prevalent Xx size second-line population the have about that XX,XXX incident Or I previously plus about guys the patients. population. the

you how opportunity Zanza? pull this capture with can think into much or that you wondering Just and/or market Cabo of

P. Haley

for P.J. Joyce, Thanks the question. is this Yes.

a I of kind those the prevalent I you as mentioned, incident larger. are population much think X,XXX given year. -- is the in mentioned, patients And patients as new

I wouldn't out think before or the it upside to play marketplace. potential where label in want I speculate the we get a to might on

But the be given many could we of of X-K patients an where might there certainly patients, I be more this the that's that disease cetera, receive therapy kind of many is baseline, think indolent et think lines kind when there. and about patients that out

in confident need the until I Cabo. in again, really sense market very But get that. wait get opportunity to comfortable of X,XXX potential a is being patients it for as But a good we we to and think we're really the significant

Operator

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

Unknown Analyst

Two you [indiscernible] financial quick one, don't One if Scientific. mind.

impact there Medicare Part from In us of terms mind Medicare D [indiscernible] franchise? part exposure, next do the you year one. reminding that's of for potential stemming companies kind in D so called Chris, Cabo your redesign, exposure the Several the out

would sort then Cabo provocative a passive am Is So any kind that X determines of one, or in radio on curious, I initial based it perhaps labeling difference those diffusion of in two, And questions. how are the a experiments? of why Part transporters have that you perspective, is? working maybe from hypothesis that do was be of very involved? data, versus kind partitioning terms Zanza. are differential

Michael Morrissey

It's take Mike. we'll Part punt Dana, it over second and then you question to Andy. P.J. don't question. first, D Thanks, for the that why Yes. Medicare

Dana Aftab

Sure.

humans. in normal for was first differential of data Thanks partitioning sort mass the generated partitioning, into tissues that the in into and Okay. terms data question, we rats, this the of the for Yes, for preparing really in so That Andy. we view got. is balance studies

So that drug. using was radio-label

course, metabolites that anything and everything of that's attached So else radioactive to that tracer. the measures

and we of that mice mass the actually sort experiment the I showed from again et spectrometry. And by terms concentrations tumors in tumors generated protein that and cetera. by normal tissues. on was similar compound doses the tissues slide determined concentrations side-by-side In free doing free that where drug were the of drug saw plasma. Which concentrations of the a we just at determining normal experiments, in and in representative several data came were one binding those

happens. go living we're many than protein, lipids and or components other data. that still lot like binding, transporter a person, so pH-dependent obviously effects. into how different how that of distribute There's binding, animal generating a effects, into of whatnot, drugs which a go are the membranes, of including So different pieces puzzle lot this within things involves protein components understanding other There tissue

happen. more had happens. out full this hopefully to say surprise us must predicted with the or But say this how driving and So publish full what we're model these differences. to data I understand data [ is the is try mechanism those we anticipated of will would stay still a these ] happen gathering apriori. not to was And see I drugs this tuned We would just that that that as it to lay data generate that

Michael Morrissey

P. Dana. Thanks, Great. J. ?

P. Haley

Yes.

And will Part to know, D you of to approximately the Part accounts XXXX. our for Medicare XX% continue as regards with evolve Andy, in D that So business. the IRA,

also be and for even will $X,XXX lower cap a out-of-pocket around be year, spread patients will monthly out over basis. the next So it

even the that . is So burden further. thinking reduce potentially could the patients on

Operator

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

Jay Olson

Zanza, STELLAR-XXX? mentioned Bristol the What's can interest see expect with Optuolag combination you. For And should Zanza we Thank Optuolag some your proof thinking and level non-small combination about you talk when cell for of in in and to data. clinical of lung concept initial recently cancer.

Amy Peterson

Amy. that. Thanks the I'll Sure. for question. is take This

are variety with in and [ and STELLAR-XXX agents, we LEG-X ]. of in PD-X including do a expanding we IO addition other STELLAR-XXX both saw slides, you the in cohorts CTLA-X have and in So combination to that

We will present it mature. the is data when

just because It cohorts. takes to you DOR, to line you get you early PFS. are while get want want these of a ORR, to want Some get

wait Some OS, of we events for just have we have event-driven. them they're report And that. can to those actually on also before

[ with looking the When collaboration combinations. IO, doing, we we're combinations have ] we're it partners, I combination only IO, IO but at to also that HIFX comes with alpha, interest other presented not and various also the

we So remain we should I the we'll combinations go open. we're but would go, we and say are data-driven. that And where us tell

Zanza combine all full think other rather that's at agents well to is uncover I and of actually with tolerated continuing the reasonably for ability to that doses. we're identify what these that is straightforward

combine data we forward into so that the don't XXX to upon be Zanza's to an XXX of terms to the with issue additional studies see that to And think move just has agents. be there's ability of decision matures It we it -- cohorts. and these made in just in the any as has

Operator

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

Unknown Analyst

just plan on on the the to for in does up Part I years? was specifically asked also pricing follow to of these Cabo Exelixis will wanted the that Medicare how specifically D earlier. question And impacts? coverage restructure And Akash. on Kathy coming is catastrophic component impact mitigate how This the

Michael Morrissey

in the Thanks years the comment to want This going for question. Yes, on ahead. is certainly to happen Mike. wouldn't I what's

expect 'XX to beyond. have We idea a and what good pretty about to relative

where I that's to we've navigate how really that sense going good have wouldn't to that So different in beyond got And confidence want those opine and we again, of degree what's a high changes. happening XXXX. of

steam So beyond, talk and when about changes to moving . ahead and get we okay? those 'XX then, we'll full

Operator

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

Chris Shibutani

on repurchase understood I share XXXX. understand necessarily plan the that wanted recognizing IP for us in Board approved sounded to contingent lean the activity, could in your and development on earlier that specifics. release aren't ask it and the completing I the had allocation prioritization But also full repurchases as think tried business of capital you if between you sharing help for you year share I thinking you MSN your if outcome you to intentionally sure it Joe was the the the just make of to allocation Perhaps included front. more Great. decision the BD that because of perhaps upon

Michael Morrissey

assume for I activities certainly Thanks X mutually Yes. not question, the Yes, would exclusive. Chris. those are

We quarter. for years. We've cash. profitable of been have free generating plenty every cash We're

to the do I both. appetite think have we

our in certainly business of be billion. want bottom As Chris share and the terms last by makes previously. sense the will about add we've to year year -- the additional diversified portfolio, platform and products between all we talked that context this to The our shareholders. use move having top and buyback both assets we commercialization and The $X offering of growing late-stage context patients others development and a in line that to line the of needle growth in for of can idea

ANDA certainly steps is business. are want the beyond that the are then we So the getting maneuver -- to I options the relatively we with straightforward in very think the we excited of have Getting place, next ahead priority. us. about certainty we with first have Once how

So thanks a want. and you for at later the question, follow to up time happy if

Operator

question next comes Our of from the line with Derek Archila Wells Fargo.

Derek Archila

cabo both see in that future? approvals of profile do much just, how guess tumors, from in change the envision and How how one growth the today? the cabo acceleration could neuroendocrine potentially So prostate us, volume does relative we in you I

P. Haley

this Derek, is P.J. Yes.

significant my we want of medical both need. to this I'd comments to areas volume. or kind for give CRPC, specifically NET that beyond certainly, with on guidance and obviously guess, of year, don't some unmet earlier revenue I reiterate of matter, So regards

broad As patients. patients treatment to with talking setting mentioned, tens options have thousands X,XXX really in line opportunity regards ultimately in market, second the I treatment really that we a is of is NHT NET therapy, chemo potential obviously have of the again, plus broadly, be being and but -- large limited options you're . CRPC more primary a with radioligand about to marketplace.

And we opportunities. to opportunity market significant opportunity should and the the for patients help to about bring them really be there'll excited we think have very we're So growth.

Operator

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

Silvan Tuerkcan

prostate you cancer. for want And the about I just and sales to a us trying kind ask cost I'm RCC of NET cancer? potentially in tell overlap is, force in between call what's can points sales incremental to force the potential and prostate to, launching for get what basically,

Michael Morrissey

terms why RCC P.J., both NET you side, Yes. Silvan, the on the GI HCC question, address prostate and for don't then thanks ]. of in and [

P. Haley

for Mike. to, happy question, Thanks Silvan. Yes, the

the terms even the in onco GU setting with start particular, really in whether an I'll really overlap of or RCC. So right? -- We are So significant focus of it's in treating GU see oncologists, majority community GU indications. these academia

as we So in great RCC is we number a overlap really, prepared remarks, existing mentioned of I infrastructure. my there, our again, leverage potentially for can significant reasons. One, which

without having So that to prostate potential build a invest to launch. cancer significantly for

cetera. And side RCC effects, two, who managing with these and familiar very are physicians are et Cabozantinib

certainly be something would in So well. as our be favor could that that

plus is GI a are of related. With XX% these lot regards to XX% really plus NET,

well team, We as, as call with both if there's as GI-focused, GI a another tumors. there sleeve you -- in those who the as our are sort is physicians well. will, treating in well overlap points, NET as have heavy again, academia, are our and community who of of

cell prescribers according really So comfort a many our again, for DTC launch or a us to nice in [indiscernible] where market to HCC, and leverage tumors the into positive well cancer, thyroid as all a of carcinoma. and it's have existing different infrastructure potential our market research in as existing whether lot renal familiarity frankly, experiences settings it's

that's forward we So certainly to. look something

Operator

Lebowitz line Our comes from Citi. of the question David with next

David Lebowitz

ruling? on the overall unfavorable Cabo different indications. evolve to When clearly Zanza focus MSNX strategy strategy effort seems going forward, an event that an the Does discussed it's in versus it you of

Michael Morrissey

wouldn't speculate we Yes, -- I the wouldn't right to David, now. thanks to Yes, want want that for on question.

to in in still that. made targeting We data. how to TKIs, the would safety, we terms be we've we're going what It's think looks overall forward. And to commitment the I that's TKIs and activity think of of still So We Zanza. suggest like approach emerging plan an Are overall have the evolve over developing early. totality the improvement [indiscernible]

on we're the we how in combine discussions a lot there's I all with having, a community. So very in we're Zanza. excitement productive interesting Zanza lot think, of And about and there of might

there. So a to lots lot of opportunity, do

So tuned. stay

Operator

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

Lee Hung

neuroendocrine population. up tumor on prevalent the Following

of heterogeneity details any stratify population on the subgroups are to can you Given I tumors, provide. you to appreciate prevalent planning specific focus initially?

P. Haley

Should believe in have of our we gates. go very as criteria status, Thanks we're really what need that's origin, et right community very we ad site will opportunity of from they of And and really the with, focus much we because have treated perspective hearing the this for out gate, say therapies. be of physician inclusion well broad study a SSTR kind whether P.J. is would mentioned, and be the in cases, patients. to the new patients I who broadly. is appreciated given of been like this of have think adopted Generally, what previously as options, question. And cetera, all really a that, Jeff, coming Yes, now receptor we I what some boards, of been approved that for out these in on right launched we for variety patients I in have

So I position be would and we certainly would it opportunity, as think it a broad to such.

Operator

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

Unknown Analyst

is This on Etzer. Luke for Shumlin

those? going key that the to are the factors any are of factors filings, And for ex those? are what those also only for those other For you there are are for be to filings looking are timing And what filing influence the prostate waiting NET and U.S.? gating going U.S. filings, on we

Amy Peterson

This is Thanks, take Lucas. question. I'll Amy. that

collaboration what dossier months is to non-U.S., I agreement what mentioned to on study. the discussions, Cabo And data regard call What doing the in submit in really I needed So Ipsen U.S. we're that Takeda ex for able is and a are can't a Japan. going order the BIRC in comment we're filing. to With in Cabinet be to with hoping on for and our partners non-Japan. we with in by -- collaboration for be under focused filing. and to the we coming for complete the the data, are

point For coming there's terms X for than going out, favors trend showed of Statistically will the on is was to risk-benefit that probably profile fact study. initially required given we Cabo CONTACT, be radioligand were which I mentioned positive also had the assets We order we favoring anticipating I study -- PSMEX, where in think, to I the else that -- also significant less that just nice OS have in the [ study cancer Atezo a is of supportive to months. the a ] nice really not in what we're a OS, -- in X. very OS which The close is announced above hazard final for a one, trend, ratios is Novartis patients. prostate positive. a

conversations so let tuned. and you the We'll how filings know stay with And agency. progress

Operator

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

Peter Lawson

and thoughts on Chris, buyback especially just negative a be or question a accelerate? something there's outcome that, that around on you'd the expanding IP, if share would expand

Christopher Senner

Yes, the thanks Chris. going We're Peter, on questions. It's as I'm the depending variables different trial. MSN what the on not going for to we're around outcomes on speculate to -- done executing the $XXX our year. the in and $XXX in remarks, rest quarter, we're committed we're on did mentioned the committed to . prepared I first to we getting this million million, do

Operator

closing questions. Thank host the are turn for no like back over further you. remarks. And call to now At time, there your to this would Varant I

Varant Shirvanian

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

Operator

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

You disconnect. may now

Exelixis (EXEL) 30 Apr 242024 Q1 Earnings call transcript