Earnings call transcript Q1 2023

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis First Quarter 2023 Financial Results Conference Call. My name is Towanda [ph], 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. may You

Susan Hubbard

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

March Joining quarter Scientific our who progress are XXXX. CEO; me President Medical of XX, Haley, call Officer, our Aftab, Vice XXXX Vicki on and our with Goodman, Dana President Chief Chief our Mike Executive our and and Financial the will Chief Morrissey, Senner, ended review Commercial; first Officer; Officer; Peter Chris today’s our

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

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

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

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

Mike Morrissey

across the leading priorities monotherapy and Advancing for TKI and thanks status our the components for first line market development and the line all as disciplined to its strong Exelixis Susan, and call and of product in TKI quarter first to on everyone you, portfolio build manner. Exelixis second segment. business. a both RCC our maintained had Thank the CABOMETYX a today. discovery us joining I-O thoughtful Hi..

it's only shareholders I I here. The patients care the drive but statement want growth way business. We're two. of cancer. to to it the we create. we the for more in obvious, improve standard help, R&D The It's for know to repeat with is patients impossible we more value of disconnect a the

singular estimate unmet a of with of building FOR Our differentiated in many that we CABOMETYX clinically to We today. medicines help patients pipeline pipeline the populations focus and annually, multiples used of medical advance large need. by is high seek number and to with patients R&D commercially of tens is of we're cancer thousands

Our success with isn't end beginning. the game, just Cabo it's the

never and therapeutic Molecules make centric spanning advancing be and discovery, small in biologics on agnostic move needle or biology in aren't work that our of perspective, a With are from in modestly gate. patients discipline will for for compelling interesting meaningful framework development it within drugs that build cancer to value shareholders. commercial, for focus modality narrow a and will oncology. commercial indications out We molecules integrated strategy the and the

integrative commercial since biotech overtly midsized and exclude, includes relative biotech is to important, reasons. we commercial compounds and with oncology XXXX. the highlighted to data bridging clinical, advance. launches on by choose And scientific, those we competitive success strategy targets for our The Our strategy historical as and pursue our R&D R&D not peers of

approximately and avoiding approximately revenue product pick product less future. respectively. million the in have many We launches and $XXX drugs while billion. insights XX the CABOMETYX the repeatedly do the in targets the winner, the oncology, past, so $X.X net and $XXX and of to discipline in number in hottest for this net revenues global productive XXXX XXXX avenues with median Approximately of mean compared timeframe the million addressing were with global

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

now And call to the turn I'll over Chris.

Chris Senner

Thanks, Mike.

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

higher expectations. in cabozantinib that quarter of primarily net This experienced growth franchise in quarter quarter we higher for PHS to Medicare deductions the but XX.X%, to was in gross expenses. in is the D XXXX, first increase overall line the and the net with to Gross first XXXX our related than XXXX which fourth the Part in of

have Historically, Medicare the the the moving expenses calendar first year, to D many of at D year. higher to due quarter in normal we start the experienced Part patients Part of the

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

conference we most first down fourth bills quarter earnings trade we mentioned call, weeks of QX as on inventory observed trade fourth approximately as I quarter inventory well that in XXXX X the the XXXX. units, As our the XXX of in of experienced drawn bills

revenues Total [indiscernible] approximately million their of on in cabozantinib. also revenues, approximately $XX from of collaboration Takeda million royalties $XX included including sales earned

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

in expense compared the approximately $X.X quarter million quarter XXXX. first approximately for Our quarter in sequentially decrease The for for expenses benefits were by first the first XXXX. driven million taxes total XXXX in expenses income for for lower fourth of fourth compared the $XXX XXXX approximately million was of XXXX. was the of to primarily of R&D income million, operating total Provision taxes $XXX $X.X the quarter operating to quarter

net first net Company net income approximately stock-based also Non-GAAP basis. fully income reported million share XXXX. share $XX.X a excludes net other fully compensation per or per reported tax The approximately or the million expense $X.XX income income diluted GAAP related $XX effect. quarter impact approximately non-GAAP of of of the a $XX million basis for on diluted $X.XX on company of

to and supported provide XX to and are cash ended expand presentation. which by investments March XXXX external to XX, allows on of this guidance, Cash Exelixis activities of from pursue to ongoing through to in with our we business cash operations the for $XXX investments year us and we March flexibility pipeline, return invest the our And the full shareholders repurchase capital finally, $X.X our was opportunities detailed development approximately our earnings billion. discovery financial share million Slide level quarter of XXXX is announced internal in This program reiterating our flow year.

to over I'll now turn the call P.J.

P.J. Haley

Thanks, Chris.

cabozantinib. and at a XXXX of to a resulted to execute line which in prescribed has number quarter continuing for Team quarter the continues TKI strong was HCC. RCC second be first in one high-level The CABOMETYX

combination is CABOMETYX number plus one TKI renal in with Importantly, carcinoma. the first I-O combination nivolumab in cell line

with -XER follow-up overall the nivolumab is ASCO XX.X at to Physicians months find plus and line resonating prescribers XX-month long-term of Furthermore, presented position survival be CABOMETYX of plus CABOMETYX median the GU nivolumab data CheckMate the strengthening in first RCC. compelled.

the XX% QX In business, XXXX. TRx to in XXXX QX relative year-over-year of terms volume grew CABOMETYX

also this to volume CABOMETYX in Sutan, CABOMETYX TKI XXXX basket the stable QX at relative QX lymphedema of Looking in time was in Votrient XXXX. period. stable light of TRX volume TRX was and market for

starts patient strong demand in new Additionally, the remains in first quarter.

the share from CABOMETYX again QX perform a to market in competitive XX%. marketplace at TKI perspective. both and led in continued CABOMETYX basket TRX well

previously, extremely line we're of this discussed in the have and we nivolumab setting. in combination competitive pleased RCC As first performance the market CABOMETYX with with is

setting plus prescribed which line clinical was QX in TKI RCC one was practice the Uptake number groups RCC. first line nivolumab the plus across second I-O in broad is CABOMETYX full in risk first and quarter combination settings. the

prescriber consistent quality the of -XER experience of CheckMate physicians life safety seen and and positive efficacy, to the that be it Importantly, data. to date is balance continues in with report

survival in data been as follow-up XX-month has presented an median data These from months sunitinib. is for study comparator are The prescribers, over of ASCO GU viewed arm representing and the extremely nivolumab at feedback compelling Long-term to on the and XX.X positive. meaningful, XER the the months, plus was clinically data are February. XX arm improvement CABOMETYX overall the

Furthermore, data discontinuation nivolumab balance of patients of of rate low on their believe enable longer safety, that Prescribers and stay using physicians terms life. of experience combination efficacy, plus support to believe data to results. achieve and of therapy this in that CABOMETYX the tolerability the quality these

feedback continued data in plus XX-month data. the We to RCC. momentum and entire the believe every leadership We the benefit XER in prescriber first positive has on our one marketplace data patients reinforce for have as growth prescribed team the day from are position as the Cabo. the pleased appropriate opportunity CABOMETYX ensure position to works line I-O with These that CABOMETYX number TKI these

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

Dana Aftab

P.J. Thanks

in depth pipeline Okay, has times so number Lamb the previously. discussed Peter a of

some reiterate of I'm I'll today, So that but instead, to the on features key the underlie not that going pipeline. touch

of reduce of on limiting the approach to in we're strength pipeline target risk Our complexity action, biology. a we're targets success. tumor one first, to overall or strategy address biology is designed the single biology number of Instead, for ways. ability a dependent of science our the not mechanism on tumor aspect prioritizing At based to and of their

our limiting small for molecule our are fully both discovery to efforts. we biotherapeutics enabled We've Second, and modality molecules. small internal capabilities not now

specifics focused strategies. programs targets Our synthetic selection on patient focused primarily programs or Biotherapeutics are primarily by on discovery drug immunity. innate monoclonals in focused on are lethal small conjugates antibody clear molecule with our And

Our or in risk. clinical greatly earlier approach preclinical and prior informed reduces programs. clinical by pipeline proof-of-concept data our view best-in-class from a that's This target takes

then and programs SP greater beyond cognizant detail. are you, much the here's discussing pipeline the So limpness be two advanced XXX. the in most programs Thank that these we'll

the So here. for underlying strategies summarize I'll them only

the the easier combo target areas have Both have where to programs aim pursued with already pharmacokinetics on cabozantinib. where approved. same, optimized. that is potentially is our drug to target and prior explore built molecules have more to have allow here but but and an combinable active, is then combinations profile have clinical to experience experience us the builds clinical registrational evidence with of The to obviously on profile, space white been are essentially these where is novel the explore Cabo same trials, we we not also that manage in The

monoclonal cervical with a antibody factor novel stability ADC. of TIVDAK, risk and technology of that profile the reduced vedotin known targeting in payload which XBXXX together the ADC is molecule combine linker on tissue factor builds XBXXX that result for next tisotumab against our bleeding with intact of is tissue generation a the increased approved cancer. or

novel a access The where next end we agreement arrangements efficient programs Cybrexa way currently option are assets pay capital our option Cybrexa Sairopa. These drug I'd back a stage like structure to with gives to loaded agreements programs and Phase The two X. an for with on conjugate peptide with our us in highlight clinical option are type a success.

of sensitive designed mechanism in I CBX-XX enhance a conjugated is novel action -- exatecan, a to But this of peptide mechanism a to pH ADCs, the this antigen action delivery to exatecan of occurs fashion. topoisomerase inhibitor. novel tumor independent is tumors. a unlike This

PK human it targeting These target which novel known issues with to Servalpa The a alleles on large designed the to gives major give cell. all the ADEUXXXX anemia red us CDXX sync and monoclonal and a SERF-Alpha due CDXX. checkpoint on option directly CDXX antibody overcome for potential. Sairopa some SERF-Alpha is agreement targeting potential was expression CDXX. for carefully an ADU-XXXX, blood SERF-Alpha, the of ligand of myeloid targets of best-in-class include to

is the development, a ADC, payload targeting pipeline, tissue bispecifics. broad also preclinical in topoisomerase ADCs we a but of tumors. biotherapeutics solid I the targeting follows in microtubule the XBXXX factor XBXXX expressed inhibitor with XBXXX. instead have on payload Finally, is both from several factor on on of range Tissue and

payloads the to which two payload to the different So having most tumor the different tumor with targeting allows type mechanism action ADCs likely of is tissue the respond. match of factor with us to

inhibition XBXXX of payload antigen. XBXXX or known expressed XTX, combine the NKGXA. PD-LX natural either The checkpoint is ADC, and CDXX but complementary of killer bispecifics XBXXX the and targets checkpoint, innate proprietary Catalent's broadly next-generation immune myeloid a a two another cell inhibition technology. checkpoint conjugation linker XBXXX pharmacology uses this also the one with tumor site-specific

going of stages In small addition will these compounds and multiple we INDs molecules to forward. programs, at earlier and a of biotherapeutics development programs both have provide in source maturity, that discovery

development. programs to those Having the for enables data with best clinical real-time successfully on make based advancing multiple decisions to only through potential prioritize us

which we're biotherapeutics several development fact, In come new year, small on to deliver molecule will from program. this track both our and compounds

is Our several small critical of biology to structural reached introduction of the last were optimization lead when of the key molecule one team mass compound. which complete capabilities, guide to able year we help

molecule a out. than on was using over components discovery And see biology cryogenic our both very delivered organization to to been built as group less XXX resolution pleased highly get structures small this Structural electron I'm the has steady for a solved the in say year, this can you fully slide, And prolific. job being needed final X-ray of Despite microscopy. high they've stream and crystallography structures. they've already of one

been These achieving for selectivity. discovery known liabilities medicinal our in lead molecules structures some Using of we've able resulted also recent programs, competition. with for and chemistry significant potency driving helpful best-in-class in status approach, very lead and this of in way to programs guiding as have have been in evolution efforts toward optimize cases, advanced series a our

balance platform, structures structural group inhibitor which discovery of complexes, programs. in also field, introduction original our only get these in helped that ever. drive we're x-ray strong kinase a of That had solved structures, to had remember faster crystallography may generate you structures dozens to now but their X,XXX cryo-EM of group able the that with than discovery over Though we this

and remarks, to my now the over Vicki. for turn I'll it that's So call

Vicki Goodman

will continues on our of on trial. year. XBXXX, I in reaching programs, stage and later the pipeline, clinical XLXXX registrational progress escalation, this provide advanced a the as Today, dose most focusing as on Dana. decision focused cabozantinib Thanks, we and updates Zanzalintinib go-no-go are well our and

trial for improving rapidly to strong pipeline we As cancer the clinical advance we molecules on each focus continue for our the patients. to of strategic our outcomes a goal execution refine retain with pipeline of approach ultimate assets,

with our with we next-generation demonstrated Zanzalintinib, has escalation Zanza entered September, begin profile inhibitor, manageable year. a development presented from our I'll toxicities. tyrosine of which last last unexpected STELLAR-XXX, kinase dose safety At full data that cohorts ESMO no which

cell presented carcinoma, preliminary in renal activity of had who including evidence previously Additionally, exposed we cabozatinib. activity been in patients to

received clear efficacy data completed with starting the cell the expansion and an of enrolled in XX cohort. cohort since We cohort a These milligrams prior preliminary response therapies, X enrollment XXX at months, of overall have with XX%. multiple patients have in including follow-up RCC received having patients roughly dose for patients of now median full full checkpoint had cabozantinib half prior the is combinations with rate the

where as the response Responses well as were naive seen XX%. with in rate treated cabo patients was cabozantinib previously overall patients

in are for a unconfirmed we of awaiting confirmatory Additionally, the the PR there population stand. is results one cabo naive whom

to We complete conference efficacy be provide the profile. tumor activity and in for Zanza for the provide also to year. the continue of encouraged by data development is cabo evidence data to this safety safety, likely for emerging program. leveraging type and The both medical inform upcoming a submission data Zanzalintinib support cabo-sensitive set, later planned additional an These including

Data both these we will continuing inform and dose to nivolumab-relatlimab future cohorts for look combination. as in XXX, are registrational the of enroll these from tumors STELLAR-XXX Zanza solid on with We plans forward they to as for as Zanza mature. well additional expansion sharing data escalation across the combination multiple cohorts [indiscernible], and studies

Turning X the X cabozantinib with settings, survival combination with Phase endpoint with population. studies investigator-sponsored of in initiated and an wild-type and The RAS the durvalumab. non-MSI-high to Zanza regorafenib signal atezolizumab based COSMIC-XXX, detection Exelixis-sponsored trial mismatch first study, hypothesis with combination in repair trial in comparing combined was from on proficient trial line with study. promising patients for CAMILLA, Zanza overall primary We of data this late cabo the similar with atezolizumab in metastatic versus colorectal a cancer our STELLAR-XXX,

to and these the rates care. studies XX% suggesting robust were activity standard population current respectively, wild-type of CRC in the XX%, RAS Response in relative metastatic

late announced monotherapy from a in histologic Additionally, studies, X have Zanza with to nivolumab the combination disease. other RCC for STELLAR-XXX trial of certain X treated patients the the comparing cabo in last nivolumab. sunitinib combination with opening of as trial came year, Phase subtypes this we and previously Data been not one to who metastatic support and cell non-clear

cabo papillary randomized non-clear sunitinib of X rates RCC In where with nivolumab was Phase cell for X sunitinib. non-clear activity in for to trial, with patients in were XX% RCC investigator-sponsored subtype and the longer seen cell of showed the a X% with Phase patients compared an and in was study rate response cabo cabozantinib combination XX.X%. Promising NCI-sponsored PFS response in an

With these X Xs on Phase of are the X now track also year. underway, we initiation Phase for this trials additional

details the for and We the studies, X selected of we'll X trial later next design the have share this indications year. Phase

coagulation targets that has competitor the to Moving potential antibody result believe drug for result interfering versus linker free to with in which designed of the bleeding molecules: areas on We the circulating the fewer to ADC off-target avoid potential stability toxicities, may first in lower or factor. XBXXX, differentiation neurotoxicity. was antibody this cascade which conjugate, second, important our payload, in statin-related of with reduction risk; leads First, including tissue

We as continue by circulating safety demonstrates low the well both the be profile. free which payload as of levels PK, to encouraged emerging

nearing declaration enrolling mature. and monotherapy to are tumor cohorts expansion dose data as recommended We solid expeditiously look for of they forward presenting as additional multiple as well a

to cohorts detection signal drug's inform registration-directed allow profile safety into efficacy the and trial. These pivot us quickly and will

each on for types. combination Additionally, promising out will the cohorts carry and dose combination continue combination into tumor the a to expansion, to to determine bevacizumab in other we seek and dose nivolumab continue escalation approaches forward to enroll we for sensitive recommended

that previously For study with atezolizumab CONTACT-XX, of meet primary half carcinoma, progression-free evaluating progression-free partner Roche, sponsor X study the atezolizumab CONTACT-XX, castrate-resistant forward with metastatic the along survival this the in we advanced treated cancer our alone to ASCO. did versus survival of in cabozantinib the primary renal X combination combination trial to cabozantinib March presenting our We cabozantinib, forward prostate second endpoint of in data in the endpoint announced look and cell readout in for with at with look we the in year. Phase patients Phase in and not

development of believe who largest assets to Importantly, study performance for to we continuing pipeline encouraging. upcoming continue inhibitor-based data with of look molecules the both make at the of they forward these patients and our in and mature as expedite promising medical progress have emerging provides the advancing We summary, and are data In the benefit cabozantinib RCC danzolitinib CONTACT-XX patients date emerging received the to data on XBXXX sharing set the single-agent cancer. conferences checkpoint previously that for the therapy. to

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

Mike Morrissey

right. Thanks, All Vicki.

As to on across excited at great call in franchise more drivers today, the translate our the in of is business you help Exelixis all patients a have off from as we, to future. work Exelixis, start the heard the team critical momentum the components We're growth XXXX. to the cancer cabozantinib to many

our in plans look across and the We and XXXX year. Day to pipeline at an expect sharing progress continued our results R&D latest in forward later

we're all progress Thank continued support to now across So close in nimble highly on is individual our innovative engagement every for a commercial for efforts Exelixis, call as recover single collective live activities. to build happy and for and and entire drive and business, their remain on to team and and you by range I'll our We collaboration. the support stronger the motivated team The We discovery, of development future. patients open of updating look results for interest and help of you in mission longer. to our and day your thanking to Exelixis cancer we questions. forward the culture the components achieve

Operator

the Asthika question Instructions] Truist. comes line with first Our of [Operator from Goonewardene

open. is line Your

Asthika Goonewardene

wondering yes, zanzalintinib. Well, just about

-- ESMO seems for presented at clinical the This deadline you is ESMO. submission first the it like for XXXX year, abstracts for tomorrow. Lastly, data

you X has update tell And us So an do Thanks. been can [indiscernible]. or to submitted dose abstract an to Phase the expansion before the Zanza this ESMO you to deadline you plan or if tomorrow? so combo do

Mike Morrissey

want you. you Vicki, take do to All that right. Thank one?

Vicki Goodman

Sure.

cohort. as mentioned, the we've So full enrolled I now

upcoming look adequate follow-up order and rates year. I'm that to robust that results to able further presenting cohort at I think conference, set clear hopefully, this response point the in We have to we is. this these these medical to in forward RCC on have conference now do data going forward which in more later we But cell not to -- sharing out at look comment to an in report present future. be detail and data a again,

Operator

our Thank next you. Please by for question. stand

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

open. is line Your

Unidentified Analyst

for Hey, this taking is Paul Thanks on questions. Michael. for our

so X added to Where on are full activity the the that you've questions And X also types? sort any does on readout? or seen of suggest the from prioritize to moving on development just tumor-agnostic planning clinical Phase expansion, XBXXX, X for Phase you've tumor you early Our the particularly initiations -- potentially more in the And cohort study that on that initial a program then trial. as into near-term? well, cohort especially

just path. if sort wondering criteria tumor-agnostic you for a I'm So and could plans the talk for enrollment about Thank of that you.

Mike Morrissey

ahead. go Vicki,

Vicki Goodman

Yes.

the carry with forward to move So into able development. in be dose I nearing as forward that quickly we full rapidly forward them, we're looking to into will expansion terms right? pivoting signal a pivot that we I we are cohorts looking signals, for when determine cohorts mentioned, expansion to think of very a into enrolling are those XBXXX,

types, dose variety tumor of tumor of escalation. we very terms obviously, In broad types a enrolled and

really be focused is expansion so populations. discrete on to signals determining And in going

encouraged be data the seen. Of very a molecule by it we competitive the by that informed course, profile. But competitor they've are profile will and and the

tumor-agnostic, And factor great tissue better of impact here get less of we would the look factor expression that on the opportunity understanding is rates. tumor activity. with of best-in-class us to tissue an a I response potential types express for in opportunity for molecule. really evidence to and perhaps say common do have so a this we think that be a respect to

Operator

Please our question. you. for Thank next by stand

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

open. Your line is

Andy Hsieh

questions. my taking for Thanks Great.

a And kind you you PR of mind, crystallography, potential philosophical about R&D inhibitor. allosteric you cryo-EM CONTACT-XX to the for beyond STELLAR-XXX. these more prepared you in Thanks don't into package about from a to especially highlighted if unique cell questions. to binding ASCO. And wondering that philosophical read-through, maybe the non-clear expand at that can the an one. just my populations About quick squeeze find and So trying and I'm something perspective, taking allow like is remarks x-ray TKI like capabilities perspective, does

Mike Morrissey

Hey, ahead? Andy. go your last thanks we It's for Mike. to Yes, for don't go that with one and with we'll start CONTACT-XX. questions. Dana, then Dana, back Why Vicki

Dana Aftab

Yes, was quickly in Sure. especially fact, getting to And a so question. that binding great go yes, for indeed, getting non-orthosteric them an approaches. those opportunity us structures, gives

are actually So with that programs now. right we some doing

in So long the discovery, a quickly really high data coming time. studies that coming to so in such resolution some progress structural in from able we been and haven't honestly, has see those enabled fantastic in with drug

really we're So it. Vicki? about excited

Vicki Goodman

Yes.

had So important these to non-clear study clear previously addition prior TKIs. patients both looked cell with received and IO, it's in respect across all in treated think mind to at keep CONTACT-OX, this potentially already I cell with RCC to patients

to to drug cabo control been we've there be versus thus of will will at out again, development. that's terms be point to the think for seen area I So arm the interesting a that, performance proven in historically. far what I look very difficult

Phase we cabo XX% to later we going if therapy PFS back prior X.X to the in patients not a and about line case, received then some, in response that in about where rate METEOR, arm second In go months. control of inhibitors checkpoint development that PFS have of a all was think a about median X.X And back cabo was X. and of again, case, about months saw a where, but Cantada,

compared in does capital So in there It to improvement second been seem has line. that checkpoint some a performance naive that population.

taking in terms closely recommend cabo a So I CONTACT-XX the at would data of performance. look

In in a of is remarks, in activity non-clear terms which this line the reason prior first cabo basis, STELLAR-XXX, outlined in the data, here terms to of has shown my RCC. believe the the population cell prepared I

sensitive So similar of confidence cabo gives a to Zanza seeing confidence that in of STELLAR-XXX. activity terms RCC design the we in do us with type the in we're tumor have

Operator

Please standby question. you. for Thank our next

Fong the line with America. next Our comes question Chi of from of Bank

Your line is open.

Chi Fong

Gerberry one you is This Maybe [indiscernible]. synthetically Jason America. on have Bank of molecule pipeline. highlighted for focused early Interesting on just Chi me from for more

the antibody therapies I oncology. spoke think on in less focused also pipeline, on and less we more about molecule biologic and companies when small have past on so targeted

looking curious appropriately if if in synthetically past? messaging anything Thank target really the thinks to in I'm there's compared I oncology? you're at So on pipeline misunderstand And a terms the not of that development that change how you. company about

Mike Morrissey

Yes.

So a great that's question.

lethal patients. a specific approaches a like along strategy. really approach tractable understand with in more population is completely, an So synthetic patient way how a target to it comes do We of because are the essentially others automatic as selection many

cabozantinib and kinase VHL a can we developing cabozantinib inhibitors in are Zanzalintinib. defective you defects of So tumors. synthetic this with liken VHL to types create form of lethality that these to

no in strategy. our really change there's So

tools on population. handle have a that get enable just We to better patient us

and modality we a Mike -- biology centric earlier, mentioned as agnostic approach. So are pursuing really

to based benefit So to allow the versus on target explore molecules biology to we we will most really targets that the small biotherapeutics our choose and bring the patients. think us

Operator

you. our question. for standby next Please Thank

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

Jay Olson

taking Okay. Congrats questions. and on the thanks progress, the for

trade For Zanza, two X can after you. just the Phase talk off types seen and line to already the you're you've next indications you of between intend you how Thank going the balance activity versus about combinations. programs? wave cabo where new And time diverse do prioritizing for that for

Mike Morrissey

take want you Vicki, that Jay. one? Thanks, to

Vicki Goodman

Yes.

this track Phase additional are for we trials on mentioned, X I as initiating year. So

We novel really a believe combination we decided differentiate a on have thinking in picked two we about process after size data, of and can we've and out areas where also of opportunity, of market we considering the unmet have indications. need, where bringing the

We time, some updates appropriate as will protocol developments you initiating year. some those later of but advance as through the -- in this give we trials those year far working at are make this indications

Operator

Thank you. Please standby for our next question.

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

is open. line Your

Unidentified Analyst

repurchase Greg. Hi. on on for the just one Maybe share [indiscernible] This program. is

in used the earnings? if you. that's Just quarter or or after plan quarter you to currently first wondering do utilizing Thank now it first April or active -- was start and

Mike Morrissey

Yes.

thanks in So window. when we program, I question. the mean were the for a Yes. closed we trading announced

shares, we able are $XXX repurchase purchase in been share haven't the March. million announced but -- to we we to be program So we committed continue to

Operator

Please question. next you. for Thank our standby

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

is line open. Your

Silvan Tuerkcan

and you the very much taking congrats thank for my question Yes, quarter. on

year? Just to one bar outline the about would And one what talked looking the we that the decision Thank end after the here? you of go/no-go What's you. expect lead XLXXX, that do haven't PKX still of by data you're question you inhibitor, for? could kind

Mike Morrissey

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

Vicki Goodman

Sure. Yes.

as on That later will mentioned, the end go/no-go are day. decision at the making I a dose on escalation data be So of year. the we based and focused this

So certainly evidence we terms again, activity as the data of safety robust so data both data present, mature. in And have do when and PK a PD well data. as profile, those we'll of set to presentation, are as

Operator

our Thank standby you. Please question. next for

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

open. is line Your

Unidentified Analyst

Akash. on This [indiscernible] is for

for general additionally, shareholders the what next percentage in gen ADC trials management commit question Factor spend. sense for is and R&D for team everything our this is what as I on a R&D point That's year? TX want of and cabo and So spend spend of your this wants. for else? And cabo trials level revenues, what to the versus do of to activist have guess, the you a you R&D

Mike Morrissey

into the the R&D Thanks guidance details the want question. year. on really We give that We There's lot this spend. reaffirmed I the beginning about a for at get to don't year. guidance of the that there.

standard have a forward obviously will discussion as today go heard in reviewed for the about improving in are remarks, at you've Board focused aspects you. be the the and are we of and will and that efforts As very excited robust R&D care pipeline the plans robust that in that's we've continue here that very budget we data Exelixis Thank patients, we of our on to all future. and a forward with deep the talked moving by and prepared

Operator

question. our for standby Please you. Thank next

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

Your line is open.

Yaron Werber

advancing be an in your it proxy have extensive first the X of is any pushing compounds? ended some of from way now do decision the preclinical. couple sort member bit mean, just bring to make us a I've the you sort now nominate in you. -- of the just the room And a to sense, question. more interrelated being. still battle the Or that secondly, my to you a ago one, I additional not give Maybe have Are fairly you have taking for programs Board all Phase what little relating for Thanks X of pipeline preclinical of looking clinic? to time to mostly a into you questions. you Thank can going days comments then Great.

Mike Morrissey

us to the focused Yes, to question, in approximately the the question. the and with led success day Yaron, global record Thanks the we of we invest versus forward last biologics. the which best revenue had first and success we've In data that got to molecules the best for in track assets there, behind terms prioritizing conviction are in in $X.X terms small cabo that internally regard led we molecules again, billion it's moving focusing back that that and versus year. Mike. on label of the broad on of have in that Obviously, a we externally how

So sense that the be drive know all we and opportunity of know that will We into obviously data that and continue commercial the to going a competition different factors prioritize forward. how how the and that. disciplined. And requires

continue. that the assets outside We on are always looking for good will

high We for bar very have a assets. and/or acquiring partnering

more our now. the prescient in value much is trading are versus to a equation conviction terms critical As and more year terms ago things of short-term in the you of us where in know, scientific much

the to commercial. conviction or internally in have them externally get behind with to got muscle have certainly assets we've expertise well as financial in development as We that and

of all on about it's view and our So how conviction success looks. in probability that

near-term, are shareholders. good back-end continue. is patients to Cybrexa pay we deals more will again, the for build able as for lookout then there in like see to, that and loaded, the those we mentioned, We're on value success. plan So because if Dana those for certainly, And and And we our drugs. to Sairopa be transact of like

your had Sunday. you to I I release beyond back we In terms press refer the that. on to question, of want go don't other

contest Board. the spot amongst open and agreed election as Board and we're not on moving We the the have We've did ourselves as an not company forward. a

that. So that's

Operator

you. question. Thank for standby Please our next

the question EF next with line from comes King Hutton. Michael Our of

open. is line Your

Michael King

the you questions if Thanks some big a to bit on above you're going had the to exceeded And about that R&D as on quarter. I'm high end guys. if have from the spending the for spend. end modestly into spend previous a down get guys of I over taking guidance grow an use I'm spend, pretty you the the the on then basis, year, the wondering consensus would moderate not In you've quarters want come to bolus in past, dial of it but of to sure you end the of had to Street in of in the first fourth just $XX spend. the And the that level and order a first because increase this SG&A. the your of is over the level growth questions suggest maybe quarter, million. kind by a going in magnitude our high basin quarter again, detail, you're you'll

I just get some that. So see if wanted on to can color

Mike Morrissey

go ahead. Chris, Yes,

Chris Senner

Yes, Mike.

we then R&D where from the that, we I that's quarter there. range. are below at of current in had came that SG&A expenses So from things it's had first year. quarter. the confident look things, at the that our did first perspective. And or I at even our mean But less licensing perspective, quarter, play more quarter into. some during feel a guess Last our perspective, million have which XXX annualization an one-time about fourth of you slightly the of guidance spend, an there annualize couple We R&D if we from significantly XXX, we still an but $XXX in of spend into than I go R&D won't

of still we at kind So are guidance. the lower end the of

quarter, within they it's some repeat did during themselves. guidance. the have we one-time things which the will So things, as onetime And

have. So we that in feel the confident guidance still we

Operator

question. Thank you. for next Please our standby

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

Your line is open.

Chris Shibutani

cabo you've significant in through generating tenure much a the product very Thank oncology of in been particularly such leading a Mike, have Great. and space. industry had much. by challenges certainly becoming the you shepherding

about to investors lot experience bring decade, bear you I will think and think back of your there design the now of small with about strategy the and of will and to the As like therapeutics think and IRA the kind to sort and into be molecules about thinking the the end differences a points that certain leadership. pressure how whatnot future, of sustain

with the back important that understand go I'd to the through very guide Board of the to experiences there. there vision terms things very seat you particular, be vision of would for the is what decade. curious of best continue invoices, I had of get challenges voices to and your back company think were and continue the of be the sets right constituencies you Board. speaking et a be one sense Thank just sense activity dynamics that your forth is opening experience sort to kind you've your again, of the that make of to is would There that about in be help think wealth you. salvos external how to to What is competitive eager one for And what could cetera. end kind skill to public complementary what just for forth as in and and that went of sort the

Mike Morrissey

point for are think, to in I release we of, context -- envisioned. think sure I'm view, from speak just about was. mentioned contest asking. talked me not from or not press Thanks let election question I that. the Yaron. on on what Again, But exactly to I you're we as Sunday, talked what as are it's going question The the about of currently the the our proxy issues the

happen will what So happen. will

We forward. have expect board are have a going a we very strong strong to going I board.

patients arguments We from our optimizing of with we have standpoint and the as the we -- in as travel that mentioned company a very that with cancer. to a in. think within success as really That's two the seek discussions, build of shareholder company chance Again, the I and those two the I the the the dialogue Board, goals, those are with good debates, by healthy have refining again, together. prepared we're have topics remarks, business dialogue helping to process that value my more

future. about excited really Again, we are our

generating quickly, from from fund step drive strong back And opportunities to is LICA XBXXX that to by fact as in internal going that pipeline and company we you with top XXXX, have, behind from free that using advances. [ph] as built entering cash the the line flow standpoint today, expansion business one very the through terms early to strong. actually to have wealth external from that run our as of ability the sources, is of growth program; of cohorts heard we We with Vicki Zanza momentum sources

So we about are at. where are we really excited

of forward on opportunities team well got help looking we in to much are have cancer very shareholders morale looking past. we good We've right while with by than and now, lot broader forward. a a We we're has doing is strong the and patients very basis

Operator

question. for next standby Please our you. Thank

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

Your line is open.

Peter Lawson

my expectations through Great. about rest as growth, of kind Chris, that and Thanks for of of the kind year? the guidance think we allowances for the taking script discounts, trends underlying just of how the question. kind of and any there the level

Chris Senner

Yes, Peter, question. the thanks for

like did are talked I who PHS expenses. I through quarter. patients Part did the also D, When Medicare the prepared going donor we and So gross around net XX% see to in Like said higher at see the the in hall remarks, I still we February, first it's the in XX% in be back is range year. that still for that's thinking early right net. call appropriate the going we was to range the feel the And but year in now, quarter to fourth gross for

gross are perspective. where net we from that's a So

Operator

Thank standby you. for question. next our Please

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

line is Your open.

Stephen Willey

taking the questions. for Yes. Thanks

referenced had any liver you both think meds, So just much high colorectal, I Xs the pretty STELLAR-XXX around benefit a liver of there's in incidence regimen. in don't on the XX%. demonstrated with in been think meds rate I of clinical Phase patients think IO somewhere And I way with

you the Thanks. population. this med what guess [ph] I inclusion think adding is curious So in of I'm tezo just liver patient

Mike Morrissey

Vicki?

Vicki Goodman

sure. Yes,

populations similar COSMIC-XXX by patient X late right? supported a single-arm The right? an think And think Phase essentially this line in at Phase cancer kind cohort I previously late-line they a So terms options. these and was said, I versus treatment rationale, is looking were Zanza heavy combination back the STELLAR-XXX, have patients, trials. of of colorectal very on very treated. sort the study coming is limited in with other I patients this X atezolizumab was as of two One of to regorafenib IST,

meds very liver in As you common mentioned colorectal cancer. are

certainly both represented in So of they were these trials.

would a single-arm Given the trials, of signal from that CAMILLA I is there's from of care expect what seeing, rates would their that we on clear standard traditional the that what XX%. say we of outside IST response and order XX% however, of are

on we We other course. it contribution well-positioned this to looking feel combination But potentially we believe do are be we of is have of population, overall the high that address in the that the based care particular components, standard of population. file, time agencies at like that's with obviously, to Now something the at be we unmet do in the data need trial will the upon patient should improve regulatory successful.

Operator

turn to Thank Susan to of the call would now back interest Due Hubbard? host, the Hubbard. Ms. to today's like over I time, you.

Susan Hubbard

us Yes. We happy to have e-mail, phone you be again. Towanda. you. or for call you or and by get any Thank joining Thank over Thanks you, all either today. we'll certainly to back welcome questions

Operator

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

bye. disconnect. now Good may You

Exelixis (EXEL) 9 May 232023 Q1 Earnings call transcript