EXEL - Earnings call transcript Q1 2021

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis’ First Quarter 2021 Financial Results Conference Call. My name is Daphne, and I will be your operator for today.

As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. proceed. Please

Susan Hubbard

and Quarter for Call. XXXX Daphne, the us you First Exelixis’ Financial thank you, joining all for Thank Results Conference

me Medical Chief are CEO; here call XX, of Commercial our Scientific progress on prepared development, our the Schwab, President will Joining First and our together session Gisela President also our Chief March Executive and Mike Officer ended Chief Vice our commercial Chris who Officer; answer Financial Morrissey, for our and P.J. will Officer, Haley, for Senner, XXXX. financial, remarks. today’s us Lamb, corporate, XXXX Peter and join the and is Quarter review question our following

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

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

Mike Morrissey

atezo key cosmic early Thank regulatory highest an short checkmate build HCC quality we for that doublet in discovery the of remain you, we We'll the XXXX since the development the two XX and from Cosmic Cabo line Obviously Also product trajectory a was us continue the if to our so revenues Cabo course. their from trial, the with accomplishments. to keep when we today's believe XX expect the activities. S phase in with the clinical up continue with the seven data assumptions U corporate nivo track prepared of first Please the ind efficacy, growth right. revenue XLXXX, where CDK ended and we remarks its the call rate across we one on the post strong quarterly quarter, revenue, the early with quarter saw quarters by we our to of to pipeline initial initiation questions. ago XXXcohort a thrilled strengths tolerability and advanced for first-line annualized positive a quarter, in the filing XXX, first-line six, in our trial these indications We pending report from the momentum in of in current anticipate first performance April. joining and All RCC significant everyone from with quarter XXXX RCC, life nicely extensive first-line RCC of results. breadth for novel which by significant medics Cabo net end doubling run and key of launch with and hour file of revenue for combined program, over today. three was the for DA's an XXXX, exit press get last list our your reflects results advanced billion inhibitor, to Cabo Cabo on first the the to nivo FDA accepted three near Cabo also can expect metastatic clinical results and in and growth progress XX% in we're of our and for release Along important launch and launch $X.X our in XLXXX on and the issued to Susan the financial cosmic XBXXX, approval S and which a Exelixis thanks CRPC see XXXX. new filing

forward XXXX on here and and our to team ever has provide running the longer the discovery the from foundation range and we for proud say optimization we're coming stronger that for across to that help pre-clinical progress and ahead recent important live hit development of by progress success teams I'm patients towards Our chance and both as of maximize COVID focus make in recover stronger. the out I'll small will incredibly to Exelixis is which for the future. new and saying molecule programs, our milestones to than candidates continue building urgency drive characterization our of clinical the of we cancer in close EDC business the us. believe ground near candidates new

the XXXX an call quarter will update So Chris our on who I'll to over first turn results. provide Chris? financial with that,

Chris Senner

Mike. Thanks

$XX on of included the first of operating impacted for For XXXX of net by quarter for of we're and and Cabos in the the turn milestone fees first total licensing XXXX wholesale ended related cents product inventory. compensation, first higher the net XXXX for compared income entity, of the per our company in X.X fourth upfront, quarter quarter for of revenues. total benefit net March income on Non-Gap stock the quarter million hand. as of a XXXX, decrease our $X.X also and hand, and of the Sure. employee-related for increase, for total investments that, The increase hand X.X in to the in In operating SG&A was year medics, expenses quarter included share revenues earlier gap and And the in Cabo, our Takeda demand franchise the full from $XX.X of XXXX, just revenues of the the approximately wholesale reported year. by an inventory from on for revenues financial net the $X.X first approximately for a collaboration impact stock the income was million inventory the quarter XXXX. diluted X in the according operating quarter of on XXXX, approximately cents $XXX.X benefit of weeks reported quarter that's cash XXXX provided compensation a fully the was total million decrease decreased diluted the based per to expense first in the in the quarter approximately to $XXX,XXX fourth quarter with or first revenues million In demand fully resulted $XX when fourth non-gap genetic quarter weeks of company of finally, million higher Ibsen, compared of guidance to expenses, XXXX, primary reported approximately or of $X.X $XXX.X Telemedics including expense based million company was expenses, for a tax call of I'll XXXX XX And $XXX.X units effect, XXXX. impacting PJ. weeks combined net maintaining with XXX product taxes that first net financial primarily income the the $XX.X $XXX.X total the share income we're XXXX, basis we're billion. quarter driver which the over expense basis. million million excludes million we also revenues X on of also or approximately million guidance of total

P.J. Haley

basket I first-line the hit immune result in fully team XXXX, Cabo in regards is Today TKI an XXnd, Cabo in only to combination Cabo line the inhibitor, in Cabo rapid to share by approval context Cabo uptake to will XXXX for uptake pleased to driven of medics the According Cabo setting. with QVC nivo Chris. medics QX business for market and know, discuss of of and combination And NRX in grow we checkpoint of the on QX NRX broad medics were group you RCC. received Enlighta combination approval you, nivolumab, XX% XX%. January to sprinting. of execution the resulting use Tableau in first Homedics was data, primarily XXXX market QX with importantly launch, first medics QX from the which XX% in QX Votrient ground increasing medics. over as importantly, particularly volume the CISV the or the In medics the prepared with was FDA with the Sutent and among Top Thank

TRX Additionally volume QX medics relative of increased XX% XXXX. to by QX Cabo in

in groups. across clinical key was risk and also broad intermediate pleased. a Adoption of strong with are number favorable We segments uptake poor

who As are the broadly, the physicians for about regimen. appropriate nine yard data with as they think is resonating patients

therapy, new specifically seeing community Cabo We beyond other the this competitive see significant access the we geography. I'm sure which Well, all representatives opportunity in from be by variable accounts uptaken. that competitors providing growth begin reopen you medics industry setting these appreciate rapid community with to particularly stage launch community adoption line to patient in is improving first-line Recently metrics, shows on been for account research we've in this is market share of initial market depending there and and segment the combination for at trends given The continued of share, begun Our market we're share to the believe is has the in taking in pandemic. strong many setting. reasons, already well. early can won't Nivo academic details as

and is with their who, Our of which discussions to continue prescribers education for XX will important and of improve who compelling data, the our that belief have therapy. patients find RCC, continue this virtual plan our the setting. to drive receive of community new to tactics yet comprehensive a execution both share in-person coupled This in should and patient launch with trend market for facilitation

the combination awareness risk launched of on are aided Orr combination. this FDA safety [inaudible] patients for by In March on marketplace, medicine their GPU, prescribers. on on medics, of in the Cabo. focused XX importantly, the beyond. We're increase of been the including the The optimized groups combination, growth first-line who in well life. across XX of forward. IMTC may Furthermore, to Strong combination of strong O time. tolerability based capos presentation yard the Nivo data benefit and focused by thrilled that the view continue Cabo looking It are lengths starting quality in rapid favorably physicians as of publication profile should a viewed across addition XXXX the perceptions of S Medics England PFS milligrams at service and update XX a clinical unaided the provides cabozantinib the daily of impressions key to performance been and in differentiating only the dose approved the the are efforts support the in extended overall the approval continue XXst, categories, of risk of including end One important of of plus data of nine uptake safety the There's which the positive. position, very revenue of April NCCN recent by favorable quality as opportunity to Cabo driven points yard of with medics Xrd all teams significant guidelines new is excellent ASCO franchise is the on answered the preferred improving QX have execution efficacy the that These the trajectory uptake broad combination published excellence in subgroups, category. and Cabo also the regimen and life demonstrated of the launch. for on of of as continuing be recently journal perceptions therapy and of broad is positioned

me, build the foundation development where working continue excuse the future optimize to our, upon RCC already access number XX to program. we're we we one prescribed potential medics of plans TKI As Cabo is cabozantinib in on beyond the are are

potential it in with across As look combination building multiple and such checkpoint this and to as all Gisela. to different we the as turn partners, franchise And call day development commercial forward other Kaaba immune clinical highly and benefit of Cabo I our HCC, lung inhibitors to and to every patients, and on will forward over as our indications with combination momentum compete broadly focused the with maximize motivated continue eligible RCC, potential. indications, to team build advances, moves program, bring DTC, future remains and evaluating prostate medics, that, the its and we to

Gisela Schwab

treatment RCC provide to PJ. programs, European first-line after in by regulatory the commission for start in of development ER, first-line EU patients opinion FDA agent progress advanced for the a you, regulatory in pleased RCC. programs. Oni quickly having combination exciting growing porno starting new positive an as up reported on with in a as in presentations from nine, certainly for is as the EU of volume is I'm XXXX and single including XXXX Thank in late hookup the volume non-gender the thereafter RCC great and chip combination with results, and COVID net Excel GU Excel February combination The including checkmate development Cubs, approval achieved update to And pipeline the progress, March, well too. the the for after cupboards advanced patients approved the January, to the as combination onto off Geneva at clinical well puppet of the on with study. a from cup ASCO treatment a of XPXXX, CHMP

an now trial our cancer, to yards on Geneva. update conference are ASCO further We and the program thyroid checkmate turning looking XXX, phase the a on results also agent three mix to on for upcoming differentiated data single Cubs ongoing with based from in presentations forward nine

DTC for therapy. new received radio XXX, We have for and COSMIC for the on chip as track and summary potential continued execution XXX highlights covers trials are on on have these signings. our XXX XXX previously as program XXX, who of including iodine, a on targeted provide patients key studies NDA a prior milestones the shared, refractory I'll brief cosmic three GFR

on towards in medical the unmet working NDA population needs. based a submission have an with We strong patient results

phase And on of in the covered As designation and completed in new metastatic quarter regulatory line triplet endpoint and response your mid in was and independent announced late three previously indication per up cosmic in event a concurrent of enrollment RCC pretreated XXXX. expecting novel cruel SNDA with comparing the [inaudible] filing phase on and complete PFS and if of real treatment and in trial forward during patients results overall cancer globally its cosmic the analysis interim [inaudible] we therapy, a anticipate hormonal highly analysis we'll March, XXXX top-line completed results second NDA plan radiology intermediate the and of of, primary FDA met to non-small or program results, versus mum across for lung based contact these XXX, for of an results, and by trials submission that's quarter quarter, breakthrough CRPC a top line warranted significantly, in versus pre-survival quarter, we our trial XXXX study of second advanced fourth we granted the survival ipilimumab focused pretreated a inhibitors, We event HPC therapy final and nivolumab poor line the patients. results data versus free patients first of And three ongoing enrolling three checkpoint three are the XXXX a analysis XXXX. and in global survival IMTC. patient now first driven look to the that the the analysis and if RCC XXX, we For file to collaboration improving and for rates risk an volume the we of the looking in the and of the Roche, progression the phase May, objective forward with placebo the cohort expect six three actively and COSMIC are the data for committee to for for of for the progression are Serafenib CRPC patients, to cell providing by of under driven all score study XX,

So met for combination in progress escalation we with providing data in as continues turn and the shorter and XXX finding NDA, charging trials part well Mitchell make and the are remain one supplemental to months, data new Axel atezolizumab and Mer in inhibitor compounds midst with phase significant on Excel we kindness cupboards our or the XP program phaseXB as track for to XXX, study. IND in readouts the next next couple phase summary, progress generation no potential a of the of advancing XL program cost. XXX on pharmacokinetic our Life of a are evaluating first and is one parallel and programs

for into recently setting the chemotherapy, entered to additional inhibitor with are a clinically Merck including in a as clinical after containing second actively with combination KGA approaches who pre-clinically therapy continue have prior program. the to as urothelial which failed and further patients prior well novel and evaluate with under we targeting collaboration mechanisms maintenance and important cohorts, agents first-line XLXXX opportunities Importantly, in agreement combination various checkpoint will setting in this various we development containing in define cancer platinum Valium up discussing checkpoint line in have inhibitors

on settings. Kinase We covenants have see opportunities build and deep with on therapeutic expand foundation and and extensive experience inhibitors, and a many and [inaudible] it, the solid utterly thing, to

in plan lines XXX for XL of potential combinations. indications we tumor As for therapy

profile experience, potentially development greatly typical versus programs. stage more XLXXX risk the review early this being Given improved extensive as

broad inhibitors tumor established in new broad late a new other with therapeutic combinations, intend potential across comprehensive with partners includes So therapy with and comprehensive We combination plan various that, start [inaudible] trials. checkpoint the pursue and interests. the checkpoint various lines as of evaluation development driving of of to indications and well we forward. setting That are as to inhibitors, stage pivotal tablets, goal including potentially promising combination XLXXX program

dose candidates ranging candidate hype rapidly the potential [inaudible] are phase factor. we on the as We allow for factor. that efficient dose tissue activity. escalation trial development report team of the data-driven progress as designed based recently forward of compounds, late-stage for CDK cohorts IND not been They're for XPXXX, That's too the And early interfere one or second antibody initial options soon the conjugate, much variety with and phase have a rationally biologic with across to advancing a support ADC on collation ongoing. may available our to ADC assessment may best-in-class and seven excited latest Joseph's phaseX combination checkpoint this antibody is FDA's X binding the preclinical profile. in that inhibitors cohort XPXXX believe such the to been studies on into drug XXXX, and site B Ind coagulation tissue As XXXX we of for inhibitor, focusing design or announced in targeting expansion designed move progress And our our started cascade targeting first XL phase these both antitumor of does with with the acceptance cords the we to expansion specific have also looking trials already trials have XXX the product that have

on that, the hand with you future. pipeline to back and in our updating to call And clinical I'll Mike. forward look Now progress the

Mike Morrissey

law. case thanks right, All

patients we're the data first trial that we've approval in medics the our in call and we a best last last launch Ipsen the renal helped for of on in with a and in in years, today, with grilling compass great today us expanded marked the meteor Cicada. opportunity of development pivotal is have similar XL We're the to stage pipeline. clinical regulatory on our S Cabo in XXXX start just RCC, including potential three and trials, rapidly It thyroid line thousands for and treat cancer, becoming partners, the the five anniversary for U excited early to Cabos antenna so of heard diverse work, program to our you tens phase company. off antonym Alexis As of maturing in about liver fifth the milestone second globally the number the ongoing of over path based Cabo on class patients the and Cenex and the XXX, the week,

their longer conditions in live to obviously advance individual in our resilience patients recover commitment, their collective were challenging today and under I'll extremely what in thanking we COVID. during stronger. mission by everyone Exelixis efforts first the cancer help close As and for dedication, and and quarter

questions a started working of it and we're in I cancer Testament pandemic you support that's the patients out our and progress in we proceed. to develop stronger for now in true happy months more exiting You. generation better therapies. mentioned need of look of our we and Exelixis. global on discovered, than in open thank your commercialize and XX you quality people please interest and to have As updating forward the effective intro, for in We ago, my call the and for the Thank to when Daphne, next a and medicines future, day continued the We're as day

Operator

question proceed. first Asthika comes Truist Your with Securities. Instructions] Please the line Goonewardene from of [Operator

Asthika Goonewardene

saw. which Gisela. of of the share the first-line nivo there. a got I some want and couple got Cabo I thanks the for my was we speak I almost don't and too right gain competitors you questions Hi strong much rebound And maybe name of detail, together then that more know and that got feel didn't than share for getting guys give to of but could was you wondering, others. us, with Daphane you quarter I I Cabo PJ, if wondering maybe the some

P.J. Haley

Yeah. of question launch. the beginnings the with pleased we're yeah, and Asthika extremely Thanks for the

prepared intermediate I remarks academic segment categories community. broad say uptake not favorable, competitive as poor only risk You what I'll extremely mentioned, the, guess I the with pleased but know, across is and segments, rapid we're my clinical

as in lot as as the look two a had say And approved the But at I that numbers. you is, and, on we will a to So I direction if more you we basically quarter look with a very share we were detail know, what respect so teens late see will months mentioned the January, in in go the we it market into at we're exiting good the and new two months those market market March. share quarter. our patient mid pleased in vectoring we point that in February at that full we're,

very so pleased So, we're that. with

Asthika Goonewardene

Do about Could us tissue have a my might this you to thinking them. Right. the think XPXXX, I of XPXXX, to Thanks. do has that with is sort can all you higher factor but types dosing of, tell team tumor declared on already you this, plan video you over you was in that you some your the an based of outlined where expression [indiscernible]? and not have push edge that

Gisela Schwab

could bind you think hopefully and intend tumor a Number the the that with drive evaluate compound data. collect course question. does profile. tissue expression Thank see the assisting population we two program one, to factor the aware not and I we that the the should for patient which antibody accordingly safety pretty it trans forward profiles and XPXXX expressed we coagulation for, in broadly as as and across a is rational types of mentioned variety number it design clinical favorable And and opportunity cascade, interfere for it's into of

aggressively. So I think to broad opportunity we it have pursue intend a and

Asthika Goonewardene

Yeah.

some here provide color could Peter too. commentary maybe Ask

Peter Lamb

Yeah.

And view, concept the antibody, different, developed. outlined linker of has point two of think there the We proof one the And kind within to year that us to on construct. or has advantages cancer. has, which This head data the several addition preclinical of pancreatic, for the add broadly which then a only in explored have episode presented of I over last were any first-generation concept, that neck gastric clinical contain said in and in the we normal cervical what to fairly generation with is we to practice say actually late advanced and she expression obviously [inaudible] preclinically from cancer. believe Just of advantage clinical we haven't does [inaudible] Zenworks some it months has is construct, warhead there yet. next a expressed, iconic proof of

opportunity the broad. is So

Asthika Goonewardene

Right. Thanks guys. that for

Operator

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

Jason Gerberry

for taking One, my Hey guys, thanks question. a just housekeeping.

case. if use HTC, Cabo challenge how second the expiring certifying then that situation. on on formulation of question, what do So did MSN one, with I was second And just when E that that's I'm so Teva, of the the business. an and four issue wonder going R materiality the same it update of to method get Whereas to cosmic paragraph, the update there the later ratios these looks believe actually wondering was two, to to with, three, because being from nine I aren't some like it we hazard the and need like or we're of they're you important disclose if patents patents are disputed a in

IP the it to case. So why patents MSN is I ask to just enforce reason more if seems those and added or you the is wondering the getting is if, reason not because if, chose like

Street's that go because of off this to assuming in And like cliff the seems a going product XXXX? is so wondering, just it Thanks.

Mike Morrissey

to Yeah. Thanks try questions. It's them. I'll address both the for of Mike

So terms the wouldn't relative some where top nascent data want in to relative there opportunity would at is size know, put on it's yard you know of hits because would we the some COSMIC of the is in about for And I to When XXX argue our first XX data question to that material a compared the on the of to I opportunity normally level framework a that probably are, so but results, that that again, provide activity to what market. to line today, as us, is currently. as of a Then relatively level practice is be we speculate XXX data. release. press finally important

know, the certainly, you that continue details we understand data. got. that with So, defined I we've practice we'll be think what will we And get when

Okay.

well. think I the from In up all of end covered second think Tebow, you pretty facts you terms the

mentioned orange they're letter, we in press came later. release four our that only as patents saw again, know, you second challenging expire or and only three in listed paragraph we XXXX that and in again, So that our filings book

new is, us. news this relatively is So this to

certainly wouldn't they're how I proceed. how about they're might So want we're on ourselves, to thinking or speculate what we thinking what doing, or it on

team you it's great to very, reform, we're you've something really growing and data, vigorously to That's great we've very in of that patent types great as pursuing defend that aggressively. got. not provide data before, are expect intention legal come estate certainly know, strong And with strong we when know, to surprised continue You updates we we necessary. the we've got all as and every to we man challenges who channels these our compounds And certainly IP. any challenge by you have it's, said revenues. have this will know, And

Operator

comes Research,. Wolfe Your Wolfe with next question from line the Akash Tiwari

Amy Leon

is Hi, Akash. for much our Leon this Thanks for so Amy questions. taking

on this? better one Do sort number? So seems follow-up three, around Could months RCC will of your with the to any this durability then it like in upside is HTC. on of question And cosmic longer another guide PFS treatment. how XX I impact one, have see three first get current you baking in and

P.J. Haley

is This the question. Amy. for PJ. Hi Yeah. Thanks

of on clinical know, data You And to the, if in and studies on study you think and know, and certainly certainly know, know, are mature remember I the are the modeling is these longer. think in potentially in duration, studies important you I for year half presented. a know, look the it's study the the that you combinations he comment for, therapy strong our specifically you won't get XX, how at PFS patients we I, very I about thinking but you

on for benefiting it's patients and regimen in launch, that forward think, you remarks. you know, more us And the getting to some and so for refills I look patients Sometimes certainly continued a leave from of increase kind know, very the it's prepared the duration the my I time, we're to at about over mean or opportunity but as mentioned reflecting time I'll to they're early then median but average the in know, growth, not duration certainly days come. more it revenue that, optimistic for you

Amy Leon

color. how seeing and made as early the of a Great. for four much data safety with Mike? on differentiation leap And would on and a Thanks so that combo And not stack will much COSMIC common internal efficacy what check Cabo then we're HCC nivo XXX. on the the XXX data in consider brave you or up internally? Oh expectation what's against competitive given from

Mike Morrissey

Thanks for the question.

think of what two comparisons Global trial with had to cross a a really compared do kind we challenging smaller. Pivotal was I different trial was it's second doublet a was, any different X triplet and to patients. molecules to really control, embraced. mix a that It first only it the, from know, and were of with was not had line non-randomized that between you

around be the that how conclusions I So I of similar you wouldn't reasons. all might are data draw same for kinds

a trials, they're you populations opportunity about And, in relative know, we only to types. And very cross we're, I you similar, two sites obviously both know, difference fair versus contemporaneous to embrace and single we're out The very same look is relatively designed XX you for those look, So enrolled the come Bev. there agents the of look the certainly various bevacizumab. excited conclusions are how when lot at they're, activity Cabo to your Atezo to tumor relative think similar can investigators. at is and own might agent how Cabo about you three

to hazard day, the we'll go P you our and, conclusions trial really the to you've and data get forward. know, of run end that o And the know, as got ratios. the values and at look go you judge off So we the

Operator

comes line question Peter? with the from Lawson Peter Next Barclays, of

Peter Lawson

our you're the data cancer. looking I and what taking of support you that for are in to approval, not follow-up. for questions. have still a that competitive the Can potentially you to we there, And but sort helps only do a see, data in when waiting set I you then take analysis offering prostate one? can see Thanks provide know but

Gisela Schwab

the the certainly cosmic So very X involving phase question, study. I been regarding made the well. it's It's pleased in to a trial yeah, large or progress think we B one, with really are

as across various we we're mature begin presenting the and and results data, about we would next. very are year this the various native and nicely, expect seeing excited look cohorts We data cohorts at to and

we forward timeframe. course second without six for next HCC CRPC months with in readout BRC, to for non likewise to also as the as the looking earlier line with the tough top a in in months the here, then mentioned there's NDA regards there were in a earlier And and well, as in the COVID of year in the And radiology few as well. lot I call, on six XXX CRPC weeks review the as finding for JJ plan couple independent quarter being And so obtain as mix or the moving well. couple going mid on of in of the the cohort dying, Cosmetic next

But important look So up. have this data for we forward course peer to, as reviewed certainly And of we to expect coming goes announced conferences obtain to data as that would presenting and important lot and them. of a cohort them then well. and milestones system. scientific And journal

Peter Lawson

we your really phase just from That's, And X data B the that's can see on helpful. studies? XLXXX,

Gisela Schwab

so Yeah. progress. making XLXXX good is

as earlier development with program As patients. it's mentioned one B promising expecting our of is and seeing a single and to have of and presented And XLXXX, are feel pretreated cupboards the inhibitors, that well, profile X importantly beginning along. and are and knowledge the a I also the And as we pathway. on experience, with safety experience it's see successful we that earlier de-risk. or lot for our we're combination escalation experience, have the dose that of with is we're Cabo the expected building the preliminary phase in that data progress a and MK checkpoint we consistent think study activity usually notably, already little one from evaluation, phase with we're on and expectation making the heavily also we the pharmacokinetic antitumor In agent mentioned moving I I phase the as general, bit in Jeanette

we further very, combinations. very that So driving focused on I are think with introducing the program forward and

I we providing. a As drive in earlier also to the and data forward call certainly little pivotal program start on mentioned development of the bit XXXX studies towards expect

we also development priority. time comes, the data program combination advancing in presented that related, Oneida to will primary on but or with when the as certainly Xcel focused the so alone And on

Operator

- next comes Blair from William Your Hsieh of Andy the question line

Andy Hsieh

Thanks of commentaries Great. that out questions trajectory and think for my on CAPA congratulations all for the the the quarter taking launch. on to, I for for PJ initial

am know, So taking in view. you macro a I interested knowing,

the during do mentioned you diagnosis kind TKI the with market the patient I the grew You outlook pool we that rate provide in rest the remember the commentary seeing us of the kind about TKA where pandemic? of Can are mentioned market of shrinking pandemic. and XX%. COVID-XX you're some to you relative

P.J. Haley

for Yeah. happy I'm question. commentary a little Andy Hsieh, certainly thanks there. provide more here, PJ the to

the basket, mentioned quarter. see CISV you NRX As did we is for Cabo QX market data, that QVR XX% the in according NRX for the by to XX% define we quarter medics grew as it for group over

So share. very to only the as mentioned that were we basket pleased grow with I And market that. product in

we And combination with excited launch. mentioned, driven it by the to regards as I'm So that. was

anecdotally and regards there's And get with year So some things pandemic, hearing are you hearing generally that it And, know, and, mentioned they see would certainly to customers semblance for think, to know, dynamic things is from improve that's I education varied kind kind continue our to helping from getting are, are know, you we is you great. us we're but we'll, with know, of to continue I, the expect things them. more I know, we'll know, obviously things think I back some of regional, what still to, with and that we change, opportunity the it access into you it's and you we're know, getting them kind and, regards slowly do seeing and normal, you of as of to normalcy. I know, but to our broadly. back that of you deeper that some customers you do

Andy Hsieh

HCC Okay. panelists KEYTRUDA retaining in outcome the All pulling for, the And also right. That's market I you. that the for off label recommended but line dynamics study? last any you potential week think implications helpful. second the FCA though, know Thank regarding

P.J. Haley

we're thanks for Yeah. all to tracking very it's PJ with question again, know, closely certainly regards the Andy you of those. something

for know, what being approved know, and know, time You now standard for to we've becoming in you shift speculate hasn't monotherapy line market of, it care the some happening what is room already more won't regards line which would even that from, in there. combination we've HCC that say the What a utilization IO completed on with underway now with well going which first-line line. about second that FDA atezo primarily for do of kind that setting of is you Opdivo, second utilization know, or you but single-agent kind in that generally about to TKI second while there, know, shift will year first seen I obviously monotherapy that, building opens of of line you as is, up Bev talked the

to, on know, market's depending how, we'll accelerate see soon to but anything to if market might more as that know, that one, be the three, potential of a know, you to you bit, And into kind importantly, see HCC, I you little think that know, there and, there'll two coverage obviously there the continue think, coming is, more you we're change. I shifting how So just, how think in potentially or reads expect for out plays out I seeing the patients and dynamically that. and

So and patients available. therapeutic going first-line funnel to speak that for to be more more options with know, you are helpful

Andy Hsieh

biologics And of the and really question was just Peter. for box. foundation maybe the strict kinda Mike new or for gained kind PJ. and one I outside -- is the think wondering us, Thanks, Exelixis

kind the So traditional basically antibody link an ADC. of beyond contract like of framework payload for

Mike Morrissey

Peter. that's That, question great a Andy. for Thanks,

to it to I'm So him. over pass going

Peter Lamb

Thanks.

view think your think is essentially I of it's period. I it great And correct. a question,

type payloads years look development at and topoisomerase point fallen ABCs majority agents, agents you been what, or another, people de-stabilizing three the mechanisms inhibitors. or classes had you or ADC to action, have used microtubule it's If type of, the DNA damaging we've XX at of know, of four discovery that and history, of of predominantly kind vast this one into, the broadly of and of

stimulatory, trying to of payloads of I a it folks see starting of to So lot the various immune develop number a obviously there's classes. novel little on in think working interest tailors, bit,

So to on hadn't our here chemistry to attractive might it plus in in escaped an that out with year this if area you point be notice of kind medicinal XX further. explore history

I a of there. think lot there's opportunity

for efforts the last with ongoing year it assemble through a our their site-specific to or MBE binders collaboration would the well conjugation attract inventor votings collaboration. Andy would targets attractive a we and kind with we be late lead technologies established and that very to the and opportunities through think that either that of to library dovetail against ATCs Katelyn I of essentially collaborations have access

and So with, all most licenses week with this the here we did with map. with, see like we with gala

that the is tuned on on, state forward question state and we're to broadly updating ADC going point on So everyone in stay doing look forward. what

Operator

Yaron of Cowen with next comes the Your Werber line question from

Kevin

my is taking follow-up of this Hey, Yaron. the previous one is to a for for about Kevin Thanks This Cabo. questions question.

is, You going options renal you know, you're getting in be what making in the across maybe cell. of share Could great little or all guys as sticking in as what Thank much you compared Cabo QX? And, QX are board. are why from one first-line opposed on and and first-line option besides what's to feedback to Nivo fraction physicians obviously you. the color progress NRX certain quarter embracing to cases many quarter to payers may over they pretty Cabo other with are

P.J. Haley

Yeah, is thanks for the question. PJ. This

guess the data. with start the I I'll numbers first So and

Cabo, Cabo guess QX the and for our, Particularly January and seeing was pleased data. since I QX of you in the market of on was of in market side the volume mentioned the market way medics. that is growth way pushback XX%. basket payer You seeing you share the actually was And there. came we're the late in XX% we're XX%. over medics And know, the really had approval NRX minimal we're we think NRX payers an about our really start know, with a, won I for what share She QX,

know, if cut a data the physician of perceptions, policies sort I we're with that's that from really clear So know, education. level and the think And great as of good you sourcing, of really adoption I payer pleased perspective. you mentioned, know, broadly great you

make particularly to get to have of the progress. seeing, continued in educate know, continue more we're opportunity on things front more we to think community, database They're And pandemic. open with to optimism we'll to really regards think in the you continue around get up what the certainly as with I we I physicians optimistic. our

Operator

Thank you.

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

Michael Schmidt

the well, taking Hey I here. great of my perhaps Congrats as questions on first, question for questions. first couple guys, thanks XLXXX actually quarter. on pipeline had mechanistic a

of Could toxicity translate how with pretty us improved had then help mechanistically obvious potential into it's I Nash So this to question. the to half-life Cabo And your and, you Cabometyx a that molecule medics? shorter relative benefit could and deal experience just efficacy to probably with understand that second we'll relative profile. a the easier it make

Mike Morrissey

we commentary provide don't Why take he don't let maybe that, ahead, go color some at Peter? a why can Yeah. we, crack Peter to and

Peter Lamb

but, combination, the the to profile one we the the all with, single antenatal a cabins was So but as so much experience could to same correctly that maintain with off we targets is target the of think goal overall use agent same I Antony hitting have ratios stated, Kevin's in is you extensive that the major build clinically, and offline. this and pretty would

make well you the a side provide effects that. fast as chemical is you the do you aim and The clinic. dosing manage of the to possible. shorter appropriate And a, at this has out certainly to site way stated modifications as played in some a, happily that doing last helps aimed half-life So management of know, and

of you can individual know, would say, chance for clinical and optimize benefit. So I overruled, them dosing with anytime maximize patients, you you dose providing the your

Michael Schmidt

Any you. thoughts Thank there? Great.

Gisela Schwab

it's And, as to as said long course other to device patient's the of I everything and dose comes duration shorter consideration. another handy with it's, there, the dosing perhaps addition is whereas adjustment spot offer, as stability. Peter and thing think Fastenal patients in benefit and for dosing half-life perhaps as of combined maintain one in agree additional just course continued is the about add perhaps to I benefit that

Michael Schmidt

know, XLXXX such be a cycle of although or where is positive P whether just et in noticed a CDK And context you more one this one a patient then for to example, expected two, preferentially cell active and would thanks. Great, we sets targets, the seven us genetic pursued population. Thanks on CDK others we've or that's here, much. in a cetera, be so inhibition a there, now in as CDK is that just or XX, broadly interest lot seven certain remind whether biomarker target and

Peter Lamb

Yeah. Be happy to take one. that

and uptake in the you're see say you'll I specifically CDK again, interest upstream of CDK broadly. [inaudible] which fits So been right. in classical And seven is another absolutely actually cycle cell This has would and CDKs, KXXX target the the CDK approved drugs. those of, of approved activating for which are, cost obviously responsible it's the Kinases. also which of six, for upstream of, of It's were of, four cyclical

either it in in orchestrating of initiation of its role orchestrating directly to pre-initiation the for factors So role it is regulating the ability a kind play transcription cycle. phosphorolate There maybe the to does complex. transcription also some as well the of mediate or or major transcription help cell assembly

cycle the sprinkle plays side. than cell one it predominantly but the, more producting So on on role,

as lesions seven look cycling might more genes. cycle. is expect our lot something it's, B being activity you the tumors if in the CDK cell of own you deletion, CDK for amplifications various on inhibitors, in focus A that of vitro that including So to do at for contemplated tend working affect R the or it's that of vivo, broadly indications on are profile as have genetic such the active, in example,

Another potentially of treatment four, to a as a, upstream six as is become tumors obvious seven it is, in those. is CDK CDK inhibitors and that place for resistant

reputedly, So drive think a including there's seven lot a that's lot And the of around. CDK helping with to potentially go of the inhibitor. interest I a

Operator

with comes question from line Oppenheimer next Olson Your Jay the

Jay Olson

CONTACT for plus approach? nine one comment XX driven maybe is progress. And Oh, on thanks or, depend atezo the some atezo that Hey, expression biomarker successful. levels Cabo Could on you the on questions. into to two the or potential would plus non-small all or first-line lung congrats move taking cell PD And other cancer.

Gisela Schwab

to presented course studies seen Yeah. prior ongoing that treated XXX encouraging for of received from I've explain so patient previously data and combination is already you. ICI XX thank this Sure. have the who just in And the patients. CONTACT X pretreated with setting COSMIC study. activity CABOMETYX inhibitors population the of and Phase CHECKPOINT in

also one perhaps we're selected we patients intriguing and with I or not to combinations is XLXXX TIGIT by and for therapy setting, the very conducting to of patient then is antibodies XLXXX earlier cancer, forward thinking the TKI of will there's be remains as data is PD combinations certainly cell confined with about think in expression and combining thing when Roche interested seen. space combination lung whether in [inaudible] combining and, then work that the there opportunity And and the be this line to with broaden Genentech lines Taser that perhaps as interest, be ongoing that certainly and earlier PD-LX population. some go relevant and could that that further non-small

covenant. to lot XLXXX of for a it's course a certainly opportunity a I and think So of space for lot evaluate but interesting and very also

Jay Olson

you. of question your molecules? small any between very in or maybe seen if could have synergy XLXXX, you stage sneak I any early shows preclinical And another potential helpful. That's that ADC data Thank

Peter Lamb

comment kind Yeah, work in actually yet, that's a That so I great is but tuned. it can't of question. progress right on now, stay

Operator

the MacKay RBC question Kennen line Capital The comes next Markets from of with

Kennen MacKay

of me academic know, to, gaining and sort on a some where some in what Thank that, that well, physicians a tumors the or would frontline on traction, Hey, here. bulkier to combination their whether quarter, whether with may that Thanks. hearing appreciate you had a then you feedback deep that question more is something is CRS in congrats wanted using potential dare guys patients hear you're I'm market thanks from the to its it or, know, as most squeezing just induce such they X, wondering was, or if be result there, DPRs. for community it's was there you about market was of it's the super the broad qualitative team as just again. and of I say. we've fast and And super,

P.J. Haley

Hi the Yeah. PJ. it's for Kennen, Thanks question.

it uptake defining you You know, think clinical across I you categories. it really you or, know data has feedback really know, so speak, resonating subsets, as been the that the as I want and received we've IMTC as the of variety to specific sort as a that is is it mentioned, broad to that know, is you of be the risk if

it say, data, intermediate curly say based favorable, So it, poor, and you wouldn't this stage, tuned. know, differentially but I broadly. And I'd really on we're the seeing stay early

spectrum, types of across gotten a risk that That's the in but favorable you in something NCCN are, really those later Cabo know, your setting, are began patient that say in just certainly the patients, certainly you on of generally recently a us gratifying hallmark category. certainly know, a the category you to a know which place those of you about know see the Moto think recommendations kind think You specifically well all it's, know, of you end a to you be therapy see other I physicians symptomatic thought it's as And know, comments data risk one doing that's used even needing has of I XX see and we've said been groups. response.

we're particularly uptake continue and, it's for that know, physicians in that'll patient gratified us setting. provide we're momentum and from think their to you seeing that favorable all patients. across types I benefiting But

Operator

next line comes Paul the Choi Sachs Your question from Goldman with of

Paul Choi

indicate let and the indicated that this one And everyone. programs, from first I with be later there's early you regards patients might follow-up is have maybe the but financial commercial both by initial Hi, enrolling, enrolled quarter. also data are me side early Chris. on two my year, some on the good for possible or studies and congratulations then to could whether early, Gisela know I for afternoon, had you a those contact question My

Gisela Schwab

Thanks. two Yes. one and three and I'm that for CONTACT matter.

with study event this depending on these expected sure. are sizable, the a are we're words for studies the relatively the of involving be end is studies year. and progress patients or, and PFS large points pleased These X itself. The and endpoints Phase studies, available data to time and All and Phase of your the or to globally, not course X

So expected to that it's will before little take a bit and longer not be XXXX.

Paul Choi

for seven to Okay, you well. then thank give for you And a for could it as know, it And year. I last a was quarter, one start, this that. for as you benefit. the million clarifying inventory you and quantify quarter a start half I wondering it Chris, just think then a highlighted if strong

you left chain. You, on guidance

end know, the So I revenue of of was the just least raising at what much. was you low curious, you guidance? sort very thinking behind Thank the not

Chris Senner

question. for thanks Hey, right. the All Paul,

units at but we if quantify benefit four it's you a it at million the you think costs So about and it, side, about inventory and perspective. wholesale range didn't XXX the this net $X I half, time, mean and on know, our our about acquisition net in

net So pleased perspective. quarter to started detriment And our a with perspective the this were we from year. then guy's very where know, you we

and the competition monitor very very There's, lot launch. market. continue lot the to in a the to dynamic to, it. said of in market it's months going in of, from a early we quarter for we be two perspective. the, we're into from continue a had continue quarter you going there's And performance continue, We the know, to to and months it we're was, into a It's a two about there's

So future it the it and at in you to revisit we'll in look quarters. continue know, the

Operator

your And question from the line Instructions] Stephen with last Willey comes of [Operator Stiefel.

Stephen Willey

Good Thanks couple afternoon, quarter, prostate for questions. the squeezing on guys. of quick in me just and congratulations a

within I there's single disclosure Cohort. of, single this data been the some COHORT guess Atezo in COSMIC I design presentation that's COHORT So a trial agent, agent at of time will indoor additional XXX cohort Cabo X embedded we terms a of think see the

in you that present six quick if a with to wondering just have conjunction then Just plan and COHORT follow. disclosure a

Mike Morrissey

roll probably on that all Mike, we'll opine or to early a it’s It's speculate out. how upon little bit too

understand but relative to up we a date in the importance investors You on filing. of know, the also happening, data to both relative what's to keeping

Stacy, at then we'll So get let's but the done w that data and roll out appropriate time.

Stephen Willey

some to Perfect. And, could to, of would, there's these think to think patients here any in you only you of a and broader do I you. that limited treat baseline? regulatory Or you have disease that that going would label a would is Thank measurable tad dialogue, do allow with a opportunity disease well? an that that the bit bone get to of be FDA, patients as at you language guess to, with

Mike Morrissey

to of want the on, wouldn't about talk discussions wouldn't I to outcome want on Look, know those that we and you those the Yeah. I have, speculate discussions either.

that labels were I safe studying. with think that it's to usually say wine probably populations

about view. think would point that it of I So from

that probably we with go, know thinking know, again, time. that get to you releasing appropriate we'll happy when share way I about be but safest you you we're and far that we'll, think the the to at information that's

Operator

I over host today's so and questions Thank further Hubbard. turn the will call you. no are Susan to There time. this At

Susan Hubbard

you happy Thanks for you, thank your conclude. today. additional us after take calls again, have follow-up we Certainly any thanks everybody to joining And Yeah, may questions with definitely.

Operator

you now this you Thank may conference concludes disconnect. Ladies and participating. And gentlemen, for today's call.

Exelixis (EXEL) 7 May 212021 Q1 Earnings call transcript