Exelixis (EXEL) 6 Feb 242023 Q4 Earnings call transcript

Company Profile

Participants

Susan Hubbard	executive
Michael Morrissey	executive
Christopher Senner	executive
Michael Schmidt	analyst
Amy Peterson	executive
Chi Meng Fong	analyst
P. Haley	executive
Anish Nikhanj	analyst
Cheng Li	analyst
Asthika Goonewardene	analyst
Tsan-Yu Hsieh	analyst
Joyce Zhou	analyst
Akash Tewari	analyst
Silvan Tuerkcan	analyst
Michael Riad	analyst
Dana Aftab	executive
Etzer Darout	analyst
Peter Lawson	analyst
Kaveri Pohlman	analyst
Christopher Liu	analyst

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results Conference Call. My name is Towanda, 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 today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations.

Susan Hubbard

thank Quarter for Financial and Call. and the us Results Towanda, Fourth Exelixis Fiscal you, you joining all for Conference Thank Year XXXX

me full who will our also our President progress P.J. Mike Medical Chief Chris the Executive Joining Vice fourth our ended review question-and-answer call quarter December of the CEO; the XXXX. and are Senner, Officer; Officer, Scientific Dana our and Peterson, the XXXX and Morrissey, Chief Financial Chief Commercial; for today's on and year President Haley, are our call. today our and Aftab, Officer, in will on call Amy XX, participate of portion

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

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

Michael Morrissey

that reviewed XXXX, for you, in a and cabozantinib Healthcare we're us today. business. We're at and the advance to see in in January joining our the which the R&D for into already call year busy efforts components had strong important Exelixis outlined in all of after sprinting update All December. Conference. thanks our we Day we to We foundation Susan, priorities to XXXX, January of at our our has and on where franchise in the across corporate drug jump-start JPM a to U.S. updates globally right. at Thank everyone provided continued development growth pleased literally the our XXXX and provides XXXX news discovery important

I net worldwide XXXX. XXXX will partners review cabozantinib fourth revenues to market leading and as franchise revenue. XXXX. XXXX won't year-over-year Highlighting full leading billion today franchise XXXX, our million its grew year were to fourth compared global product product Cabo full a grew monotherapy quarter product here business revenues saw role in first-line quarter approximately focus financial respectively. strong TKI Chris the and and XXXX, performance his second-line growth but TKI, quarter generated its including: for the reiterate we RCC revenues the maintained and in the on for and the everything quarter fourth demand year just first, and prepared net XX% a continued in remarks. Exelixis both full net top of status the in guidance with full by year as cabozantinib segment. Fourth IO franchise year highlights, CABOMETYX cabo $X.X $XXX its compared in TKI XX%

in submitted a weeks half MSN be should October, in XXXX. for ruling the the cabozantinib expect of in that the briefs the reply and company the for this and and took franchise. Obviously, we final second next place milestone a critical the first trial few Second, is

to did specifics While molecules we and will will of respect work protect patients other the continue behalf speak proud on today, cabo rights presenting property cancer. I'm and not and that case. our that with preparing to has intellectual pursue of our any we to Exelixis our vigorously this team differentiated with

at in XXXX made we R&D advancing Third, in progress in highlighted our presentation Day that significant pipeline the was December.

in And December, years as key from heard priority lot ASCO shortly. Zanza to extensive The IND that at few tumor sites recent potential development with advance existing now enrolling Chris. please address achieved buzz cabo CRPC. continues sure Q&A a testing. With corporate to see generated of that, effort. an preclinical range profiles call for exciting us of compounds new for and a hour pivotal release turn our for quarter quarter. NET next cohorts press list solid be contributing and metastatic the the of this full for is milestones over priority that expansion with and full and on XXXX ago is now Amy a both based at top you indications XXXX the the in key stage pipeline differentiating extensive XBXXX a at I'll network could terms to in to session our year is global to new critical issued trials Our Dana is financial the a of GU with potentially and presentation address CONTACT-XX new fourth indications our meeting for an results in of

Christopher Senner

Thanks, Mike.

For expectations. of million revenues cabozantinib approximately approximately reported CABOMETYX million. franchise net in the net fourth our with product included XXXX, was cabozantinib $XXX approximately total franchise company quarter XXXX were net sales. was XX.X%, the revenues which the for Gross of revenues and million trial in line product million, of in included the clinical to $XXX $XXX.X which fourth quarter $X

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

that Additionally, to we are XXXX the our net for XX%. estimating gross approximately full be year will

co-pay As due gross the in D of expenses. to higher the Medicare past, first Part we've to year, tends seen in quarter to be and net primarily the assistance higher

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

$XXX income million licensing lower GAAP of company operating for expense of quarter and million quarter was to of XXXX diluted the the of of share impact fourth R&D related for effect. basic tax for XXXX, net excludes per expenses for million $X.XX of approximately total a million third net $X.XX for expenses. Provision per net compared $X.XX of expenses, was non-GAAP million total $XXX.X for $XX.X the primarily quarter income related for $X.XX income XXXX. also Our The expense $XXX operating of approximately income taxes was the approximately or approximately XXXX. in fourth driver stock-based income share taxes which ended of were million and in $XX reported the approximately net were share primary The to of diluted. Non-GAAP of reported third per the XXXX. $XX.X the decline $X.X the XXXX per of the a provision quarter the income and million fourth to December quarter compared approximately basic investments approximately $X.X share year billion. XX, compensation or company Cash

year shareholders program return by and the detailed billion turn back our the million share cash is XX.X over return the pipeline financial average full our will presentation. And we and JPMorgan flow end programs, announced $X capital the XXXX quarter, million of Mike. guidance $XX.XX. This of development in in flexibility completed we with repurchase invest by XXXX. $XXX the cash shareholders XXXX repurchase share We activities, March our turning of our XXXX. And share on repurchase the through repurchased in investments, we we share commencement to Slide shares announced fourth and the call our XXXX. announced at to an supported have level to program, combining that, R&D financial When XXXX. with expand Exelixis our external we and of operations, million at price to XXXX for During of to I'll pursue January guidance to allows the opportunities in Since this January program to internal the business our us repurchase earnings XX to from provides the ongoing approximately Conference $XXX finally,

Michael Morrissey

to the thanking serve I'll discovery, wrap All entire business, great inflection our for happy every the individual point stronger and the we to everyone interest Thank for Exelixis updating science collective day our our activities. in and patients and continued for by Thanks, you team on right. to to to open want efforts is help commercial for patients XXXX XXXX, range call to to you their year recover development support is support highly a and on look We the motivated excel had Chris. Exelixis, up shaping in be live of now our We on an basis. I we're here up questions. and mission team single know and hope our an progress to ever-expanding that in cancer forward longer. future. the and your

Operator

of Instructions] [Operator line Guggenheim. Michael comes from with first the Schmidt Our question

Michael Schmidt

your question thinking context of had perhaps potential for on how zanza's a neck of of recent profile and Phase III. head specifically which pipeline cabo the opportunity readouts, initiated I I interesting about think a head the trial and we in in zanzalintinib, a the some thought just probability. STELLAR-XXX in sort recently Phase III question you sort the drives should neck in what and And confidence of remind success study where cancer, us about maybe clinical

Amy Peterson

you, for question. Amy. This is Mike. Thanks Yes. that Thank

us So reported think and of failure the you pem/len getting to to recently be what setting. might the design STELLAR-XXX gives in I study referring this confidence,

question II/III Here, about we've risk we're how your so data, doing here an of the but given earlier that is was example cabo/pem, STELLAR-XXX observed smart an we here's employed on believe actually that. design of dovetailing exact of example cabo only leveraging not Phase that a what with also because

study and was published Nature by XX.X in response cancer, study year that multicenter of demonstrated head with XXX earlier this in survival. month neck an study monotherapy Dr. survival Phase inoperable It's from to and monotherapy well benchmark cabo/pembro the a a is does the II Saba ORR versus So a median-free it rate, that recently zanza/pembro and XX.X Phase conducted metastatic month of in median XX%, patients that but and a this XX% had recurrent pembro study overall II, KEYNOTE-XXX pembro.

zanza/pembro. It So we and are that a need to the X dose modifications looking any, survival around physicians made combination very at the regard review -- ORR of of the to len/pem density it's beating II we're of having with But difficulty to Phase len. carefully maintaining XXX. data obviously, to public we is that rate the a of also with the study the once well think pem/len also observed in if benchmarks was study to median what XX% going LEAP XX% that response with we've progression know negative, be demonstrated I an are what, of progression-free months. median-free assess a sorry, doublet and

where target inhibits dose that this not So but and interfere why at succeeded of point and the lot may the can with also and in, from cabo TAM permissive len, can profile there's out in [ results doublet dose dose. families as zanza that ], in differentiated when and you And activity zanza multiple thereafter. have a reductions very cabo, combination that with has the cabo. Namely, MET that succeed. in reduced reason same profile start enough actually doses reduces reductions, full that course, could however, of environment combination zanza/pem be cabo with require similar we started is have immune I'll big the results whereas a profile it toxicities a could dose zanza even IO, reduced act of and with starts we at a with in of a further tolerability it

we're study we'll So LEAP neck, our that the probability head we in represent and from a confident data that eyes but pretty pretty of combination and head keep high success. with zanza/pem are the in on the testing neck

Operator

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

Chi Meng Fong

This is Chi Jason. on for

around discussion After a chemotherapy question. whether ASCO there was is arm. prostate, the presentation, appropriate on one two-part GU the Just second a NHT or control

side, And the to FDA do treatment with arm into you have fit the I'm see alignment commercial CONTACT-XX? algorithm you regulatory setting? of the do in the in refractory and So control how choice on the CONTACT-XX radio curious, on the side, relative chemo on

Michael Morrissey

Thanks, Chi.

start Amy the with can And commercial wind comparator that. question. P.J. stuff. have then up Glad Let's you with asked the

Amy Peterson

Thanks, Yes. Chi.

patient. So And with KOLs, arm for start I design the III members by either Phase a arm We room trial. This we this When exclusion identify again, committee criteria, better her the then the would option is authorities was presented it mean If contemporaneous in felt that equipoise? discussion second a patient most score, why a Chi a suited that for actually that outside means in to disease. health symposium, discussions available is wasn't in presented to a in in we every patient maintains out option If treated or has this the amongst and candidate candidate discussion every patient settings. felt for the ASCO with mentioned determined with that Chi. treatment option authorities, for KOLs demographics NHT, work that physician that be equipoise. And for for collaboration wasn't in the not study, treatment I control that also just inclusion different treating health appropriate the with enroll. We see steering our patient conducted me patient as reasonable similar study. physician by what are volume do patient this would we pain patient to in trial let Dr. by do patient, a studies with clinical for investigator to an enroll with the the Dr. ultimately treating is to GU already our of develop not disease, our and example, with patient be heterogeneity his expect were high high at expect

arm, of data on studies Susan some by in III a Dr. a Small, GU in meta-analysis on metastatic at versus comparator ASCO For both look patients of Halabi and you CONTACT docetaxel studies a patients and look even castrate-resistant on X had XX% President, I'm up PSMAfore. And NHT. with of prostate had liver X/X example, liver III PSMAfore, the disease PSMAfore. metastases. randomized when with that conducted looking Approximately Phase In in going so the the in received enrollment CONTACT of XXX% in had liver versus on X% XX% PSMAfore. in on our than of the XX% patients conducted randomized And at CONTACT-XX, versus docetaxel between collaboration our demographics patients. actually measurable patients patient to X%. CONTACT meta-analysis pull who Phase is patients at metastases, that had setting of those cancer, percent as thousands CONTACT-XX having failed chemotherapy the X both our disease metastatic first after less did

how differences address design collaboration landscape. the PIs steering and pass with to the health and appropriate either where inclusion, look it clinical the ethical criteria is to neither P.J. in to situations are that this is is committees, at over physician we due will treating And trials enroll. now it patients commercial the the and I'll agreement authorities, All appropriate. of or patient and and arm exclusion these say

P. Haley

Great. Thanks, Amy.

lines for overall medical them. we're remains survival the this patients over rate really the of for patients significant cancer castrate-resistant who physicians treat XX,XXX only and XX%. therapy. about it. population large all, is This is for of prostate a need The a and still X-year opportunity really First unmet data Metastatic presenting excited with across

is you what we've family, the would with of around that limitations, you've have first-line think I chemo. being with before So either issues logistics have patients to all for to NHT really, options get these then in in patients patient that point discussions therapy research got receive radioligand regards cetera. And it's to that, them, and many et setting. for to want And received when obviously And approximately physicians out both the that obviously chemo. and about the exist whether market there's NHT, castrate-resistant already beyond of and XX% with RLP physicians that terms or in therapies repeatedly regards delay seen not means and they of

So should that said, there's place combination believe a we this approved. for significant cabo/atezo be it of

classes a regimen deal in CRPC here lot TKI out X Another potential this as and a as mechanisms there's for has excitement therapy those only excitement certainly, I new of sort so that available immunotherapy, there's is obviously, post-NHT, would of a of great prostate thing of action really significant immunotherapy point X, in And of setting. for a well and cancer. with need

we're treating So physicians oncology, think well obviously who community board. about cabozantinib broader checkpoint the about are we opportunity. across excited as When the population with of the very inhibitors as these comfortable are

we forward So potential in space. the to this look

Operator

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

Anish Nikhanj

It's Anish progress this quarter. on for Greg. Congrats the

on quickly Just exclusivity, and the you're ahead current again. STELLAR-XXX MSN litigation of case MSN, can presence updates speak case relation with for thinking you details the this on you of expect worst exclusivity? to any zanza, on best cabo's outcomes in to itself, framing Congrats case could then share I the can't N-X patent the outcomes but and we year? case on just And just how know cabo's potential the the

Michael Morrissey

ANDA the Yes. Yes. over question it I'll Amy. the to question. Thanks take pass for and then

and those relative not potential we're for I kinds specifics speculate want don't and of reasons, to scenarios about really the again, trial things. obvious talking outcome So on to

right will Amy? We going shareholders, patients the We the forward. move opportunity and and company continue are thing always by about the forward. to do excited that

Amy Peterson

on the STELLAR-XXX. Thanks, Anish, for Sure. question

multi-arm is has with combination the IO in a but, PD-X, table. monotherapy study but not bringing additionally agents other like IO is that -- that evaluating to So a just it zanza PD-LX

example, enrolling CTLA-X, or of that are LAG-X, therapy. for So many the of we're earlier in cohorts lines

it's the forward really looking some mature, to data so are take for time it going that to And mature. but we to as sharing does

be for in to tuned what XXXX. we stay show So might able

Operator

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

Cheng Li

line at the regarding questions presented data on on the and Congrats Cheng thoughts. have hear progress. is to actually This X Jay. to other your some love GU I ASCO for

on a momentum potentially thinking the additional also some just question, your the of given pretty about of benefit adjuvant of and potential advanced other that XXT treatment with curious in formulation, and paradigm how course, forward? pricing if saw OS expect cabo/nivo easier regimens I'm showing Opdivo to the more the may question, first the would with on formulation the create compared actually launch second potential of we CheckMate market So uptick attractive favorable you the subcu data KEYNOTE-XXX with administration. And to the in setting size now subcu setting, moving impact and

Michael Morrissey

question. for Yes. Thanks the

it I both, think P.J. handle can those so away. take

P. Haley

Yes. formulation, there's combination if and at that think a question. end and Thanks positive out. to I that's good subcu provide for how for convenience And more we'll RCC, there's the physicians wait could plays the thing. if momentum. a more certainly With thing. the But of their patients, the of ultimately cabo first-line for see day, in overall that's with nivolumab regimen to options It the regards for have

regards small. overall population in a impressive eligible patients. an it's this for adjuvant certainly pembro way adjuvant -- OS for before, impressive think data among nephrectomy it see benefit I And the therapy setting, bit thought data, impact about the the about survival. regards way is really and Obviously, we first-line good is them metastatic -- talked the data, to in those relatively to that's for With the there. With to great

is some some main for after about which option, first-line one KOLs will heard or there patients, nothing said, over who take on the we've time therapeutic for But that adjuvant cabo. what play incremental believe, impact out time, them time the from being they'll patients and TKI I in first think take recurring, But the we quickly but other it'll it shortly to Certainly, line. physicians, from could setting, treatment, or there. different either obviously, but play So think for good provide in be while are will potential think to news fashion, certainly, the in a potential I out. another

Operator

line Goonewardene question Truist. of next with Asthika Our the comes from

Asthika Goonewardene

comment bit Appreciate where one to Maybe, of and you today on benefit When we've to we can got saw guys please. the color do ] long that prepared next the on an and a while. separate. can you the on little on wondered the this like that look despite you work super, [ you feel patients a how carry patients -- arm subsequent could of had if bit CONTACT-XX? Michael, the of remarks And efficient CONTACT-XX, that, I'd will when was just control on imbalance? cabo confident Amy this. We this still more super there could about than you therapy, then arm. related being us expect in chemo that bit quickest at already I being a But current forward imbalance little give talk OS OS maybe a

Amy Peterson

Yes.

questions. are So There there. Asthika, in those take are a embedded couple I'll that

who what had the the chemotherapy, time about about to it's XX% second was the receive chemotherapy, NHT patients to the we patient subsequent chemotherapy. benefit are And XX% be that want XX% to in of especially at eligible heard getting with good given actually And chemotherapy one in P.J. Knowing outcomes overall. who ASCO second we is know to GU. believe patients of from a was cabo/atezo who remember time in patient get first, to therapy, we this cabo/atezo So We actually terms chemotherapy the subsequent you of with versus delayed subsequent arm. what which of population the chemotherapy, chemotherapy what thing NHT, compared measured important because getting to showed regard arm we

at at of speculate so a OS can't benefit the thing. When confidence going chemotherapy mean, time I bad we're what delaying I think are look to and and see, can to we we on the do of to OS while we see, analysis going what not And for the is however, the were OS say And we target XX% that we we the study. only of the interim we that enrolling did analysis, what number time still did of events. I the conducted is analysis that

conducted XXX So did decrement of XX.X XXX and With medians reported that be no is hazard ours. ratio in other analysis, yet contemporaneously patients there for X.XX of to had of that that XX.X what this cabo/atezo, space seen -- that cabo/atezo, analysis we a with for we've favors see to second with enrolled. conducted survival from trend in we this at their a early and i.e., is studies said, which in with NHT have different data that

whether we patients. or analysis. clinical survival. to not it's consistent unknown. believe meaningful. the or population was matter of It apply GU is ASCO in forward diced progression-free -- clinically What the to or I'll benefit, across the point radiographic how whether we primary or hopefully looking hit and statistically population. say analysis X achieve It seeing significant the at ITT we is We're significant what that looking OS data we Group not end We PCWG no will in that final sliced XXXX. subgroups and the in demonstrated Working we're of ITT was criteria It was we to Now did showed is

all what for in OS reasons who for there's approval support patients IO of regardless CONTACT-XX. met the combination TKI the that novel believe an shows, we eligibility this final criteria so And to

at that different treating sufficient the with actually agent. agent in a is moves into And study patients with approval. It's be at approval PSMAX groups not that's everyone the we extrapelvic a is you different to is the our is look to focus comments and that whether the approved. to visceral is line. testing sort and a different focus know the and TKI enough that when believe It to options combination is to only bring The It our with patient that we earlier with earlier ASCO of can line. my of advocacy therapy. populations proceed a profile right results the that look we we is mentioned patients. this, now to job these not do the interacted in that doesn't and have patients, risk-benefit to treatment study not an a physicians a positive GU agent. Cabo/atezo It's that androgen it I conversation approved. or of options, imperative KOLs to important believe approved with is sufficient in we agent is with option we unique -- cabo/atezo it on So the an demonstrate that those therapy met going to patients. enough novel for interacted patients and IO and treated bring chemotherapy a many believe meet adenopathy, for not radio-labeled is the this. Patients risk-benefit drugs that all believe that believe totality see treatment Not but not profile want a same patients different space. The disease, exist It's mean the even different combination with access-targeted studies the regulators alternative CONTACT-XX. this, We patient an representing in the the conducted is treatment already of criteria that potential a that the option for on first getting

not able is benefit those most from it. be will to therapy combination, no one, seem receive the if not to this who However, even approved,

Asthika Goonewardene

question podium I data I'll in. up if for of congratulations at updates. us And restraint previous on there Could completed my maybe us little a really recruitment? a getting from cohorts was Chi not which this Dr. more have Maybe I color comment. -- your we helpful. know up can Can it's tuned and Can on is That squeeze follow to and -- and his tell stay saying one you give XXX. the you something

Amy Peterson

first So mean doesn't we I'm are have completed you at to just read have multiple in not able to the because follow this And therapy. time. Remember, give to that that of duration necessarily they've cohorts. treatment for we out. point to Again, they

to and it progression-free the even is cohort have And to follow follow have for completed, data we survival, We will mean the coming in that we have doesn't OS. for if months.

Operator

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

Tsan-Yu Hsieh

the ASCO financial Also, metastases cabo's both nice to you we're combining Congratulations to specifically I discussed space. and cancer was during you, Great. on in with curious, the ] conduct I'm to It profound delta. done to really the HIF-X. sign want visceral just Arcus fronts. with zanza have discussion or see that and [ at ask separately, in the regarding activity subgroup planning analysis in roll about the getting achievements an PFS out? And the it's collaboration, prostate the scenario clinical interval. scanning to coinciding the

at front. it previous cabo on of plus combination, heavy the most appears cabo efficacy doing the lifting that Looking is belzutifan

expect So do you differentiation this from novel combination?

Amy Peterson

Okay.

clarification just the I a with regard in -- couple I can get heard question there. a on So

the What ASCO PFS talking -- in you about and The data question? rule-out -- comment sorry, were in you subgroups. we scenarios, cabo cabo showed that can subgroups the So that at the from censoring? -- the and subgroups repeat

Tsan-Yu Hsieh

between was discussion. control But censoring, about on if to the be could The delta, I the we rule -- yes, was kind Yes, PFS the up to experimental interval close an delta Yes, PFS talking guess questions have of question of yes, if X you just of so brought specifically that, about arm the you at the curious potentially -- weeks. on scanning the the at basically. right, my that scanning certainly. interval. too. really comment want And And that and at arm, out the a artifact can

Amy Peterson

Okay.

you. understand question you. Thank Thank much your better. I Now

median, In general, the improvement not the between which optimal in resulting parameters median, you're way analysis, the in approval one RCC, the PFS that treatment to at recently just way back been belzutifan the really examples drugs ipilimumab PFS a looks the but here look benefit and and going to estimate, identified take referring benefit, in delta, to was have many at at to. There entire of hazard arm view positive and is separate a based the the we one curves regard are the clinical really where effect the step of hazard median across approved. point the ratio with melanoma back, a So benefit difference most yet all single time. on point at control not thing, ratio, clinical after i.e., no in experimental do the an and in multiple

especially Going have robust PCWG in very all believe into to meaningful in worse PFS CONTACT, these and represents population prognosis this than that subgroups the criteria. We seen a ITT patient according our PFS across the space. population Working overall we this observed have similar studies what we study, which conducted benefits, in are clinically Group in findings in other

control X.X of ratio subgroup, patients visceral -- disease. X.X had -- to translates the patients hazard months. XX% with improvement that We have improvement the to a what we X.X median a control more a ITT, median arm. was measurable PFS XXX% hazard of from translates X.XX to the ratio of than MET a at to median, in lot And over which saw ratio X.X over a the the trebling which In And in doubling a a median, had the In prior arm, months. saw months. In improvement we docetaxel, XX% we X.X of translates XX% fact, the hazard the of at the doubling the control versus liver observed X.XX this disease. effect to is the of over arm. X.X exactly X.XX, from

data, the And that of were evaluated other and have studies totality patients we the second distinct CONTACT-XX, the have unique is all they consider part against in of that it also not totality from drugs So but data. NHT. enrolled how and to this of are of is

need that We consider that unmet to have existent outcomes and space is the looked at. we in important this other

other to outcomes chemotherapy we in adverse example, patients, look For that mentioned delayed at. -- in These for to look cabo/atezo We to are events. cabo/atezo. actually events And chemotherapy. we the is an so We increase time at with attainable skeletal resulted there NHT what the symptomatic I also adverse months, So NHT and time NHT, time showed we Median right? they tolerated event their time profile with first prior study in these versus who NHT. These of was are are and event cabo/atezo toxicities XX the who the that them. on quite tolerate enrolled profile having well. patients patients know are second

against of different. do do you peripheral look toxicities at and We We alopecia, the toxicity the have have neutropenia. not you neuropathy. And you compared grant very it do have not looks that, we febrile of when to profile so We cabo/atezo that. not have when juxtapose differentiated. I'll But that chemotherapy, cytopenias. it's do not

it is is cabo toxicity toxicity So look diseases this other available it's profile otherwise prostate same a like cancers, from nearly profile when identical. that this furthermore, therapies you oncologists in this doublet patient. And the toxicity compare cancer at by and to treat kidney the other where IO to profile used differentiated

So a we've we that robust going we a believe very beginning, meaningful talk variety I benefit patient what benefit, support met of said and to parameters really in to a at we about here consider when population. back clinical the and need clinically unique

I Now to question, -- okay? I'll went long there, on Arcus know zanza go I okay. the but

So given HIF and clear data real about be table. the belzutifan not to zanza that bringing you might the anything being cabo/bel with in asked

similar patients take progress to a presented went and about back IKCS, zanza Let everybody cabo, we with has step be remind to drug. It tolerability me on -- we Pal Monty VEGFR at what Day actually to is but responded talking profile we're at profile zanza cabo. TKI believe is best-in-class a through a the target to what that just R&D differentiated.

together there's disease, we agents excited see that But whether think best-in-class an for ABXXX. evaluating different. emerges a in as to monotherapy We opportunity bring agent. not best So or in about We'll Arcus this X really we're a and STELLAR-XXX. have potentially it's a class. active reason is

in co-funded figure We that whether might Arcus RCC test we out how patients are -- in this us, and to and combination and move it's by study, forward. we the combination will with

Operator

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

Joyce Zhou

on broad in on just post more on patients one you're as first study of or up Maybe a to the but post whether of Yaron. patients for second-line and CONTACT-XX. NHT how Thanks color aiming for the well have all both -- enrolled is noted, This seems as, Joyce you since about that. Could as clarify, second-line received who for guys post-chemo? looking it's previously you pre-chemo or to also first here, XX% are label docetaxel, to approval whether get NHT you had

Amy Peterson

not do principles to Yes. the we When clinical inclusion/exclusion the special trial study, ultimate I'll first what the label, back liberty go design Thanks for to criteria. the I'm really to attention at design. might be pay we of but predict again, question.

and is least regulators. And All of that progressed we combination ITT who the have have IO in NHT study population patients castration-resistant positive first cancer prostate is discussed III Phase setting. that study in the what is positive would TKI with of state the global pre- patient I that one and this a both we post-chemo believe on a in metastatic at

Joyce Zhou

it. Got follow-up. a could I just in If squeeze

Looking at zanza...

Susan Hubbard

Joyce, honest. I got be to

have a of happy we're to get the after you We follow long people super call. up so list with to, to

Operator

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

Akash Tewari

opportunity much potentially spend two, related? roughly cabo's the share I Ipsen, related? how So development year, program, of in if $XXX then of R&D on the development kind expenses will were Takeda, in how you zanza specifically do of aggressively next to that kind the for how an development able is, be for So collaborating that And there at of some costs Bristol. to reason terms with here? looking is And ask number of And XXXX look of is company you million is with the zanza's zanza much zanza?

show And would I'd impact setting, on of HIF-X a zanza significant -- TKI market? then looking HIF-X actually question, a pretty on this HIF-X get alpha a really take show a benefit top last obviously, on to are to alpha if regimen. in HIF-X hits, do stepping that of to for whether studies, the just would the bounce versus back, role love a benefit where pembro combo at maybe And be see and TKI-based in versus would market. able alpha to a your pembro first-line alpha pembro able Merck that be which have and playing it the off you

Michael Morrissey

there's Wow, lot a there.

real work backwards So fast. me let

don't of and or single-agent X from X study I data. and obviously, to TKI drives CONTACT-XX, contemporaneous but I And you -- probability think, TKI draw looks. back published we're to combined to process, success comment think, questions data data of TKIs you to there. relative and the HIF-X what the Data you say, there. see can, with all how really with want refer conclusions contemporaneous, would see I compared Certainly, some data the I we'll to some of And the like published a of would asked, You back inhibitors data we seeing want on to there. data. competitor refer cabo that

update clinical our done partners of to partners our as all collaboration We're at collaborations, commercial In we've and of that Day with we spoke this at on presentation. terms yes, in well length expanding XER, the R&D JPMorgan CONTACTs, we the basically a clinical cabo. relative proud as partners the the work the to that go trials, the really run clinically was with variety to able had be of et to to co-fund. appropriate cetera, opportunity We think to various where way a opportunities working by super

the of now to a talked get don't on a move your zanza, in should But ourselves that something and want that's because us priority collaborative and few that's we now co-funding time definitive, say by the combining about around When in And manner. But with having to tight. you. we'll for with first As we ball of get January, to for the other that. discussions JPMorgan we're share again potentially at questions, to we is be with rolling. ahead that have thanks sure started we lots possibility for zanza checkpoints certainly

Operator

[Operator Instructions] the from Our comes JMP line of Silvan next question with Securities. Tuerkcan

Silvan Tuerkcan

and an about plus as checkpoint quarter. [ label as even. Congrats a cancer and ] cabo the oral on in I have question in prostate inhibitor the filing

setting, radioisotopes where earlier versus community with especially on for play the choice IV seen, patients? cancer with the community setting the we've potential Just data respect you you view forward, prostate the community already that the setting out, lack for path how the may see in how also to this in setting? a do And of therefore, do be based academic

Michael Morrissey

Great. Yes. P.J.?

P. Haley

thanks the Yes, Silvan. for question,

ubiquitous salient I losing it's and there, and themes hit bit can there. on radioligand mean oncology to Access the a some some there. physicians', when as therapy kind offices, setting, potentially think Obviously, you patient you the the not community of to clinicians' talk opportunity different. is of it

I that's So consideration. a think

the As we what community. aspects, really I previously, performance monotherapy, in strong is think I for all and in very cabo combination mentioned know, our

experience strong checkpoint community with know have with who amount variety a of treat this various experience we oncologists at really cabo I have So is inhibitors. malignancies clearly, say -- of substantial great. there a should physicians significant large which And point,

should So a be that approved. opportunity us we I nice could certainly for be think

Operator

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

Michael Riad

how specifically, Michael Riad This site or the could Jeff More there XBXXX conjugation? there deal path or capabilities loss, for the Is for company XXX for on impact like the address ADC any on following are so, Catalent? these? development is Hung. And any if linker design on payload recent

Dana Aftab

take Yes. I'll Dana. is This Michael. question. Thanks, that

in learned their with this of programs, can had we're say and continuing I reached at our we So change. immediately discussions. point, some don't anticipate And their we Catalent, any support news when the to and leadership we productive very out confident

Operator

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

Etzer Darout

sort and also on any as filings cabo for strategy able Just the more and the X regulatory not these label the the the prostate U.S. data-driven of it around comment of be cancer regulatory if indications in for whether NET here or expansion, is you're outside to provide the same planned would on U.S. color

Michael Morrissey

partners, to words on few can the ex-U.S. and/or arms a our regulatory Amy on of strategies. Yes. wouldn't I say That's want the others. P.J. comment in but

Amy Peterson

Sure.

some data. So exciting really we regard to with had CABINET,

people it. with familiar I think are most

median very or had the epNET. pNET whether has patient have of months in time a depending observed a was X.X population on or and not progression X you prognosis poor months We placebo to to that on change that XX.X

with incorporated have some the lines, get but We have we for example, independent most already with to advantages strong a us. It's was CABOSUN, central partnership to are on with blinded to CABINET review complete didn't study, hard they're The The very do radiology that into notably in with close the Alliance collaboration have, we Alliance. time we transferred and the and database opine working locked hard

comes And That's results it final so in all mentioned, regard think CONTACT-XX, discussions forward XXXX. agency I've OS sometime XXXX. already the about CABINET. And I I to can anticipating looking to when with with we to we're are in having say

with represents However, We'll the a of the we clinical ASCO presented population. to in we that discussions them. GU have believe in that the the sufficiently at bring front patient supports package on that data data of ITT totality ongoing how benefit that agency best

Operator

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

Peter Lawson

light thinking Just about IRA a we through that and question volume around in kind for seasonality especially guidance. in Thoughts on any of pricing of XXXX, should be and 'XX? revenues

P. Haley

there incur increase specifically to Yes. that we X.X% Peter, play it's want P.J. price as didn't any year. clearly Thanks our in this is now for certainly there the is IRA What means penalties The the approximately regards question. was inflation-related in our this out will $X,XXX. terms that pocket news patients good patient Medicare year with to is for The of of real be to limited revenue.

with for will patients out-of-pocket the And news we're really that observing those but Next $X,XXX. to year, have be there early from potential days costs. obviously, good it's what lower

a it, as it close keeping and and track we're So eye it update on available. yes, we'll

Peter Lawson

to think seasonality regards Great. the for And as anything should year? about we

Michael Morrissey

nothing Yes, we here, Peter. would comment on

Operator

BTIG. with the question comes Kaveri next Pohlman from Our line of

Kaveri Pohlman

on Congrats the progress.

to and with for than combination is disease? head Or tumor trial monotherapy work patients expect it in Regarding KEYTRUDA for the used burden? that mostly and Phase neck lower chemo and bulky zanza it KEYTRUDA better replace KEYTRUDA, you also cancer to is II/III

Amy Peterson

Yes.

study is no not There versus former, Very latter, quickly, just right, pembro. so is replacing is the chemotherapy-containing Kaveri. the monotherapy a zanza/pembro Sorry, this that arms, KEYTRUDA.

Kaveri Pohlman

Is kind well? tumor know lower that in used I that will is Yes. KEYTRUDA on of as in just monotherapy be focusing wanted patients. like mostly you your to trial burden what

Amy Peterson

some and the So earlier, the I inclusion criteria. exclusion made to has harkening study comments back of

CPS the criteria than tumor a greater for that, limit example, X%. score There's on inclusion tumor the the necessarily express burden. of to Some not has require

to in front randomize? enroll can't go to to treatment we disease the treatment in again, in the the So the of either for study. I speak they sitting burden arm arm, order patient would is -- equipoise. physician What reasonable study and what of

Operator

final Our the from comes Leerink question Liu Partners. Christopher line of with

Christopher Liu

median progression-free X survival exposure tumor CONTACT-XX, months On of had guys months. a of duration you median and X

wondering of is Is a Just Just quick still And driving it pipeline? second the technology guys then the a wondering what driver in what just that difference few Zymeworks? key that. you ADCs was. the Do have one.

Amy Peterson

exposure the take I'll So question. treatment

with They for had think GU chemotherapy duration reductions. variety that XX% restart. actually dose with They XX% we the of I being disconnected median of reasons. therapy They and PFS can we get ASCO cabo dose at atezo. with a of Patients restart. breaks. The be intensity take presented

in point So can it's not that I elaborate time. at anything this on

Michael Morrissey

Good. answer? Dana, final

Dana Aftab

Yes. Sure.

for So we're Zymeworks. pipeline, not in newer ADCs Catalent. primarily is through with the technology That the using SMARTag the

Michael Morrissey

recommend, discussion if interested the fulsome you're I'd Yes, R&D around that December. details, a in information pretty we in all had at the Day

at So platform and I built have linkers around ADCs. understanding webcast, both very you'll and the we a the how take warheads deep various of have a look think broad with

Susan Hubbard

with your your have. may And we're Great. to and today, joining follow-up Mike. great the for Have your questions, day. thank you for call rest take attention, that, for Thank you, any for everybody certainly of us a available we'll

Operator

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

disconnect. now may You

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