EXEL - Earnings call transcript Q4 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis' Fourth Quarter and Full Year 2019 Financial Results Conference Call. My name is Towanda, 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.

begin. may You

Susan Hubbard

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

and Officer, are commercial session Joining Lamb, review P.J. Officer; will for our Executive Commercial; quarter Morrissey, call financial, Chief on corporate, of Scientific our also ended our Senner, and Peter today President Gisela XX, me our XXXX. Chief the Haley, the President together prepared and for and fourth CEO; Vice our us development Financial the Medical December us Chief Chris our will following who Mike Schwab, is with joining remarks. progress be our Q&A Officer;

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

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

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

Michael Morrissey

build from keep today. presentation ASCO-GI right. off on for and and thanks a prepared we're to address start remarks frame Susan, at call strong as our beyond. GU to is Exelixis perspective and data Thank momentum the provide and and performance, recent on XXXX you, to updates everyone we additional off to XXXX, All and pleased XXXX our joining of our the part as us your JPMorgan update. today's the We'll short main questions in

than an for thyroid achievement see medullary extensive Please the our issued cabozantinib release of liver cancer, highlights, global franchise net for list revenue including was of that $X more an hour and ago the our cancer billion XXXX press of indications. renal across cancer the

of XXXX As across in to business. components introduced January, to focused frame we our XXXX time expect all of execution period a back be the

During label-enabling XXXX, new cabozantinib to cabo X X and to enrolling lead readouts top in trials we potential have for expect data XXXX. could line XX that indications

for cabozantinib's to in metastatic read potential been METEOR, previously differentiated data activity, and has provide and at documented CRPC, and GU indications for presented inhibitor, compounds data to We to cabo cohorts or immune INDs ASCO-GI also for into up combinations combination advance file and for a encouraging CABOSUN HCC important these ICI at through internal trials. CELESTIAL ASCO efforts. which our collaborative checkpoint in or X from expect ICI, XLXXX highlight new Recent the

who over provide fourth will So our details that, I'll on results. XXXX financial turn to the Chris, more with call quarter

Christopher Senner

Thanks, Mike.

third a units, hand at weeks quarter included for by the approximately the product reported weeks quarter compared For to X.X flat our revenues the cabozantinib million. $XXX.X perspective the inventory on CABOMETYX total declined held $XXX.X fourth from Total which quarter at XXXX, million. revenues revenues when of XXX company net units XXXX. of of was customers

$X million an preliminary accruals quarter approximately was This in chargebacks results increase Exelixis from audit. to for XXXX. on the net lower revenue annual company's financial during with is that January associated due CABOMETYX the than XX, identified product revenues the estimated provided the product net

COMETRIQ Takeda for Total higher a they of recognition purchase commercial trended revenues collaboration in from clinical partners, previously company's collaboration $XX.X include due Genentech. to also approximately $X.X revenues have trial million of than were company's -- the million. the revenues the Ipsen and

the and SG&A to expenses million the $XXX.X was total expenses, XXXX for Our quarter operating $XXX XXXX. the compared FTE third driver in to related quarter total of primary primarily which million expenses. by $X.X the expense of operating million in were was fourth increase of increased

fourth rate XX.X% tax to and for million, Income of quarter were quarter the taxes third XXXX $XX.X for was the approximately quarter $XX.X million the effective of for compared XXXX. and our XX.X%

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

December XXXX. totaled compared $XXX billion million to approximately XX, Cash at at investments $X.X and approximately XXXX, December XX,

to Cost between in $XXX and our revenues. turning expected the range million of related is we Net million and Conference $XXX product development $XX to $XXX and the of expected million are previewed to and in stock-based to million is projected guidance, net of and at noncash be of Research $XXX X% JPMorgan X% expected of be range includes goods expenses revenues compensation be sold in $XXX the expense million. Total and January product which million. approximately the to in Now range revenues $XXX to are be XXXX. financial of million.

includes million. to $XXX of tax expense expenses million of is administrative $XXX is XX% and and in in approximately expected XX%. and million noncash and to rate the compensation general Guidance range effective stock-based the related be for Selling, between XXXX $XX

new and are activities. range not investments and cash potential impact and cash This we business include billion projecting does finally, development guidance in billion. to the the investments $X.X And be of any of $X.X

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

Patrick Haley

I'm one RCC, to immune number in checkpoint prescribed you, the of XXXX. X the is of pleased and notable review ICI Thank Chris. commercial the of inhibitor, or first-line of CABOMETYX for the recent combinations. launches be TKI quarter CABOMETYX to performance fourth context continues which

XXXX QX to risk settings, broadly relative CABOMETYX groups X% grew relative continued demand in in in to the clinical and in fourth CABOMETYX the grew The RCC in relative and QX XXXX prescriber XXXX XX% QX by quarter QX lines by grew of by to CABOMETYX to in to grew XXXX XXXX. be QX relative and base XXXX community of XX% QX continues and and to increase X% quarter. prior across academic XXXX by used therapy.

the market of very quarter. first-line the launch XXXX, first-line of dynamic The RCC been has additional combinations throughout in two ICI second most given

As call, first-line QX. patient CABOMETYX's market steady, first-line remained we market and has share. new in the the new stabilize mentioned our last to the at combos RCC continued first-line capture and patient continue the began share end of to ICI QX on of majority

RCC. in the strong only Turning continues in OS the the research CABOMETYX benefit the to to line label ICI the it's to TKI after primarily that remain to point second-line due with the agent combination, any fact a Market line second population. setting per second of choice

and ASCO recent reinforced at podium. well support the KOLs In fact, was from meeting GU as meetings as this the from

is new continue second ICI marketplace who as continues to and RCC majority play first-line the patient market of patients on the see out to this We to progress in share line are CABOMETYX CABOMETYX increasing, capture pleased combinations. in

TRx stable. QX, IQVIA volume Furthermore, CABOMETYX over the on data. was other based CABOMETYX and to be the in TKI outperformed #X prescription Year-over-year CABOMETYX prescribed continues XX%, up TKI the volume TRx Sutent for VOTRIENT, and monotherapy, QX in RCC was QX. QX

HCC. to Turning

important care the TKI patients the monotherapy setting new will to untreated for line serve utilization HCC. evolve we turn, the anticipate with of a in likely We use monotherapy atezolizumab increase in of landscape similar what second could combination We get expect decreases approval market. be in HCC bevacizumab an saw will, the the liver ICI RCC combination ICI front line, will to fashion moving standard and time. therapy as which the over in expand in first-line this second-line market, cancer first-line to and Subsequently,

#X CABOMETYX. as on the the momentum RCC, eligible and and forward building this other believe benefit and program look We strongly and to remains and lung, potential that cabozantinib HCC we could RCC, from expands prostate patients many in more TKI prescribed as future CABOMETYX development such indications, progresses.

inhibitors, Future trials III with cabo may of to growth combination for beyond be XER, of immune in CheckMate HCC which Phase combination and including driven cabo these RCC, the read out. will first outcome in checkpoint evaluating the studies by cabo be ICI our

ago. took had a significant presence the ASCO highlighted, X team Mike place GU, weeks As Exelixis which at

combination in with with positive view RCC, to in and addition KOLs support In cancer, cabo prostate cabo optimism. for atezolizumab

mCRPC a the regimen according early potential leaders in heard key in to and from setting to that unmet other differentiated board opinion potential have well numerous appears advisory GU the medical need meetings This ASCO. we has significant to many an address at to be at the

day highly eligible its as the benefit motivated every to commercial maximize and to and remains clinical to franchise build patients compete to CABOMETYX bring team continue potential. all Our of focused we the and

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

Gisela Schwab

planned inhibitors, I'm program in start immune a label-enabling late-stage potentially progress regulatory agent XX as P.J. the or study, our for company CTEP-sponsored to our III ongoing in as provide and update happy includes current cabozantinib which studies. industry Thank with I'll well or brief and Phase development partners a you, checkpoint quarter. with including single on as combination

partners in and completed trial as nivolumab to study with RCC we first-line are forward the half XER, by looking groups. the reported, our advanced trying data. results top all is earlier enable sunitinib who are in plus cabozantinib CheckMate in results expeditious risk executing with XXXX, regulatory IMDC filings First and once comparing The of most the previously enrollment this We're clinical III Phase available development prepare warranted and the if future BMS the first to team, line to are year. study, in

data via of cabozantinib reached first-line duplet The study of plus/minus XX% The the for recent second line yielded the triplet and And our OS in and encouraging and combination survival XX.X in triplet the in mid-January reported HCC duplet and of conference for our duplet encouraging of with RECIST CheckMate XX% and cohort up of the with for median development XX% were for XX% respectively. Ib rates XXX combination, patients Phase At respectively. results the and control combinations, HCC new not disease in months the triplet partner, BMS from ASCO-GI reported ipilimumab. XX-patient importantly, we response combination. rates volume

year have combination with We Three cabozantinib been of initiated combination signals HCC cabozantinib with ipilimumab with as an believe or also, studies in mixed patients acceptable in that observed. patients with cancer. disease. the this second combinations COSMIC-XXX showed progress first-line atezolizumab past HCC population actively are such nivolumab inhibitors, for inhibitors importantly, and and trial no the checkpoint COSMIC-XXX of and globally. safety are these the first-line studies pivotal the trial a and single-agent in unexpected line the first so, COSMIC-XXX and excellent data checkpoint safety well RCC including, in These enrolling making The profile Phase bode trial differentiated thyroid with additional in III in

both response line all study year. rate we we happy for XXX once early of from and report data half of will from enrolling milestone As minimum X results our analysis the patients support have DTC, this second COSMIC-XXX And have the of as objective also on the COSMIC-XXX been during this that top and followed dependent as a of population events guided, reached months. we have endpoint co-primary the of patients ORR anticipate in of in I'm to COSMIC-XXX

making in working are the great cabozantinib progress, broader and III and Phase speak a ongoing is minute. concepts on we late-stage those plans I'll really development So to further program

to First, patients seeing a atezolizumab in COSMIC-XXX we're study early of Phase on And settings. And accruing XXXX the to across study cohorts. results actively a and and I'd continues XX focus progress. make excellent tumor cabozantinib expansion the enrolled with has by than different been more like types Ib trial, encouraging that XXX patients year-end

the XXX objective of this the XX cohort the the from cohort data at objective registration patients. key expansion first notably, this recent And response for early time. cohorts the to for a the reminder, X.X. And cohort Conference, of expansion results the in shared a we resulted has ASCO As rate of is involved patients per total GU first in X mCRPC

was XX%, responses. rate rate response follow-up the Disease X.X, disease. and XX%. The version primary cohort mCRPC trial's therapy objective This included per this progressed complete could prior novel measurable X partial interim with was and were including received analysis. XX.X on The XX in patients enrolled RECIST disease who per months. XX docetaxel prior was patients median have control for hormonal endpoint had hormone-sensitive RECIST, responses

for one Among an signals. cabozantinib evaluation, with duration median safety And specific The importantly, had in had all response of post-baseline safety combination an XX%. patients unexpected responding months. was the and objective of antigen prostate decline a who PSA X.X response no XX showed patients XX% acceptable at has at least profile of atezolizumab least

Based by the as single-agent and expanded on warranted trial, approval an accelerated in data cohorts additional path FDA feedback, we COSMIC-XXX from atezolizumab. and pursue plan cohort the cabozantinib evaluating X from the activity of to

we cancer and based over cohorts look year. we of at meetings cohort presenting other from are forward Mike activity. course that as at had of previously from highlighted inhibitor and during initial our non-small COSMIC-XXX we announced safety antitumor in patients January, cell encouraging medical lung this the to the various Also, this pretreated checkpoint expanding And with patients on data presentation JPMorgan

Among co-development metastatic III are studies COSMIC-XXX a as other and in evaluation initial cabozantinib cell Phase cell cancer. data, And non-small initiated. we being has these led of combination details CRPC, more with Phase announced of these they agreement will in renal and observations atezolizumab XXXX on cancer Roche lung trials X III in late to provide the from XX-XX for

ipi/nivo for our on regulatory for on with the we regulatory treated filing regulatory partner patients to RCC. filed treatment on side, Japan, the of And look updates XXXX. the authority an application also for lastly, XXXX cabozantinib Takeda, April completed the in forward previously with progress And Japanese the in NDA cabozantinib in advanced January HCC

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

Michael Morrissey

Gisela. Okay. Thanks,

start clinic. we into additional indications expect in towards As potential we XXXX, I strong a year off said the the data-rich and as advance and interim, a in we're new to cabo compounds

to new building forward assets from activities. throughout the to our We entering to for expect illuminate to data year drugs GU to new the XLXXX, on look the for and path present and continue continue new our indications momentum cabo, data emerging we development from ASCO-GI and business as clinic additional

I'll and consistent progress. everyone is and the the as look navigate you open their team in better updating discover, effective and for therapies. your at challenges thanking patients day focus who The every encounter Thank that superb support we're medicines close to for happy now cancer leadership count committed for opportunities we'll for we by next-generation interest need you and develop XXXX. as Exelixis we making And our commercialize of entire a to more in We forward on questions. to Exelixis. our continued the call and

Operator

[Operator Instructions].

question line SunTrust. of Goonewardene Asthika with first from comes the Your

Asthika Goonewardene

for few fun we've progress the this keeping the having want of Certainly, I the track can, year. I congratulations of if been A to say updates. made you a questions, lot setting. cancer all all prostate on

unprompted. about Dr. I XX when that Also, about interview ASCO running they're the noticed talk increasingly mentioned synergy something reading out Agro. the GU, you talking [indiscernible] got almost docs you're and of follow-up at an patients and one ad So XXXX data? synergy. this already with for Is XXX He ASCO-GI about your afterwards. And think half too have boards, a if analysis XXXX guessing curious something X second of I update patients. I'm the middle on on involved more cohort something Or suggest this cohort to is X? planning in am next maybe that ambitious being possible? I maybe I'm

Gisela Schwab

for Yes. This is the Gisela. Thank you question.

take in them turn. I'll So in,

of in with like keeping impressed for certainly, and per at cabozantinib few rate that response in question was single-agent that cancer single RECIST the your mind with far of people GU XX%. the ASCO Regarding very data feedback digits the we've a rate atezolizumab And synergy, low between. around the the and were and prostate heard presented response

and So a clearly, cooperative XX% people, stood activity they saw out to potential here.

being. CRPC. for the Phase the to you update to meetings. next at you receive with also we're of it can we'll the respect particular, update, confirmation the with across that presentation board, active as study in leave time in certainly think Ib very in Now accrual medical pleased data I And the But we

Asthika Goonewardene

and setting? question build-out especially the can of office, then I'm you we reps urologist need you since mean, a for Great. sales here. for force Chris would how cabo into a send what I wondering promoting -- of much And need in build Chris our cancer Mike, the expect in the kind prostate models?

Michael Morrissey

and GU have Yes, upon it's It's very to customers question. space the from the across the to and a presence the part early in of organization. with Mike. to of relative That's great little a Obviously, now. strong appropriate follow-up on appropriate the all commercial a the we detail bit components opining right strong business rest that able commercial team then of to label be being support pretty that

commercial an detailed So about how right have we're going I think that now, incremental would pretty We going and but analysis. contingent of forward? a full works as a to people that build,

and why So proper that we that speak hold and kinds and around little have to once more bit, those off we in time we things, put context? lines definitive don't data a can really filings the so of

Operator

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

Andy Hsieh

on for such very the data, and challenging prostate especially, progress it's compelling IL been agents. Congratulations Great. field a cancer all

So for is is there combo do a you headwind landscape just think thinking therapy the the non-metastatic/undetectable to settings? positioning as of into going about here, move cabo/atezo novel castration-sensitive kind hormonal or

Gisela Schwab

start others the this is and can Gisela. So of in, chime can response, I course.

the hormonal more received that docetaxel novel interest, that hormone compounds one the and received addition to that who the our agent for is data received have collected cancer being disease. for in least combination have having the sensitive we than now patients, in approved of potentially prostate have at And something could certainly hormone-sensitive landscape So because is more now course, with you is of in said, changing as state.

So to really studied as as, population and it's we've we've that, well a of some relatively tolerability that durable And the and of I've years quite response earlier. earlier encouraging what described back. combination compared data rate the seen safety response with rate course,

Andy Hsieh

Okay.

on that, just another question to related Gisela, trial So design. the

distribution the to I trial, number recently, to that XXX think, X altered X. the for a of It So increased of it's COSMIC-XXX, bit. was given kind were used patients the XX and a ARM -- be by XXX little to also

to X it's X. Now X and

XXX agent single really So together, biggest the change I taking has everything obviously, mean, versus the now cabo XX. is patients

maybe behind the us the So sharing rationale the with you kind change? mind of do

Gisela Schwab

the Thanks question. for Absolutely.

study study COSMIC-XXX course, cabozantinib sorafenib this driving the analysis. and As as of atezolizumab is, OS versus compares HCC endpoint, first-line that the plus PFS primary

In the addition, to we to have combination. contribution a the agent included activity cabozantinib the address single really observed for components of arm

And evaluation, on the so strengthen described kind size, size agent of in order early back that -- increased a sample sample year some year the last the to in have part say little cabozantinib. last enhanced as single the we and of you

Andy Hsieh

see. I

Okay. for if And lastly, the design was Contact or GU, so disclosed. at it's I X the ASCO know intentional don't not.

don't two parters, if you mind. So

look never second was cabo is what XXX combination RCC and -- atezo the at the of if the you line for So study,

tested. Formally

the she So can on on maybe progressors, she Zhang IO regimen TKI. slow about why like something or IO atezo/cabo. at for continue a just or in And line Dr. do which experience then kind Contact her IO-IO shared curious TKI, you you monotherapy of chose positioning I and might for she consider And something perhaps second think, line, might fast different, second is in progressors and X setting? said, on, opine Duke the

question. you if of kind these us curious of your on two parts insight the So with share can

Gisela Schwab

Sure.

context. to the bit it overall just in frame a So little

that of program being with conducted studies. that III announced Of Phase course, is extend we collaboration X haven't a initiation across Roche Phase and under III the XX-XX the

as discussing a GU, evaluating in a mentioned, Now is a on the in checkpoint treated design the carbo backbone this versus that trial we as new at oral as the showed you you say, atezolizumab podium pretreated inhibitor RCC session plus study. patients. ASCO cabo And previously is

Mikey highlighted labeled is free. that this contact

few to of expect, But initiated. go when much mention. course, is being we into detail just study would things a actually to the more So

as it's settings backbone care be of the First, space. I in to the the and see very think treatment now gratifying second-line cabozantinib randomized standard in evaluated to

And so that make. is to one point wanted I

is, other course, The of

and of have activity we've that cell decision look HEC with lastly we in then sharing showing that CRPC been to described cancer lung treated other in as now safety checkpoint cabozantinib. seeing That inhibitor forward cooperative data the based nice who observations, inhibitors, to is but encouraging the course, And also checkpoint previously on the of non-small were and settings expand cohort. those. yet, the was earlier patients in taking the call, activity not plus And the and

really setting So particular in reasons data at of this a lot there smaller current for time only other the single-arm where studies. to is evaluate available combinations

the Zhang investigator benefit Tian Duke clinical progressing And of and fast regarding and in benefit with with to from rapidly this think, the preferences disease we're that I course, progressors, rapid from with other of disease in patients seeing of regard cabozantinib diseases. onset certainly

Operator

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

Michael Schmidt

regarding COSMIC-XXX. the all progress. I had one on Congrats

could done it Regarding couple pathway cell think, then indication should about potentially the just III in potential here? what the this collaboration, we you've have registration accelerate you an have of I part I to pursue -- follow-ups. also I was a if you wondering I wondering and in mentioned was path lung potential opportunity cancer, as think similar a Phase Roche non-small of cancer? where And trial. is you a prostate how

Gisela Schwab

the question. Yes, thanks for

non-small I we cell cancer lung cell pretreated patients. and inhibitor we are pursuing clearly, cancer path. in therefore, activity this checkpoint And non-small seeing are think, lung

you initiating thus far, in to springboard, details time about talk a of we'll look to As much cohort course, have collaboration. III XX And patients. soon to the design detail study. the year present hope the Phase of forward, more a mentioned, study provided that the will, comes the we broader trial to in And We population we've the if when in evaluation more in-depth I this expanded now. in data patient to

Michael Schmidt

you potential in COSMIC-XXX just then the in at as to about Maybe setting this some setting. in looked inhibitors the of selective And here thyroid this cancer, opportunity how are regarding relative RET that think being wondering Okay. well?

Michael Morrissey

real Mike. it's address Maybe P.J. Michael, Yes. fast. that could

Patrick Haley

Yes. is this Michael, P.J.

I primarily think setting. that second-line to being in said about Mike think the at of thyroid shared plus we Certainly, is patients studied customers space. DTC, space The we inhibitors Exelixis, and regards COMETRIQ JPMorgan the RET in history think X,XXX many and about we've I know now. at are thyroid we background years our with know a for that and on many, medullary well

certainly commercialize company. have us a it's I So at market the lot the And given play and appropriately. one we could current would of opportunity be to out think very team excited that everything experiences a should to and give our synergy,

Michael Schmidt

the us? And that you with maybe around And that evolving a share the in Maybe, fourth gross net question Chris, about how Great. in could just adjustment to XXXX? quarter. then housekeeping do you think

Christopher Senner

Yes, Michael, Chris. It's thanks.

our the chargebacks. So hadn't modeled audit, we yes, out course accrued during of as our it enough financial determined year-end we that was

inventory. all And trade was so to related that

looking So we gross a to -- the we're to for accordingly. increased XX% quarter. for had we're range. XXXX, fourth And in Look, we accrual gross in net the go-forward looking a on basis, XX% XX% the around debt

Operator

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

Jason Gerberry

profile an of leverage IO potentially those me the -- being important IO agency prostate. to accelerated upcoming with we on and review your TKI, chemo, able relative leverage an enable toxicity for mechanism? of was I'm mechanism? to the of discussions ability accelerated review as from factor First combinations think an curious, just one about the types Or readouts

Gisela Schwab

Sure.

bit the to responses potential accelerated in as think the quite While CRPC, I X area course, seen specific has response a and discussed which consideration, just in looking ASCO in seen combining can't discussions for but as I components pathway of of combination we're that really little at approval durable as at contribution the well speak been other you've development cost, upon And a FDA, pursuing we, both as a observed bit rate GU. with course, been based in of think the safety. has earlier, a the was mentioned really has terms of of I the the therapies in the evaluation, that cohort as efficacy been it

a of to the you need if and in at other compound, arrive or the so proper evaluation for the risk-benefit combination. And will, order the profile,

certainly And our aspect the so and evaluation designed is into of study each compounds, the alone an atezolizumab we of that single-agent important evaluate only cabozantinib, program, the particular development that but we've combination XXX to built that question. to which also have agent also not address

Jason Gerberry

range, Got it. comment for just think follow-up. you post-IO Can as in atezo/cabo what the you low in to meaningful here? this think of a it sort lung, a is pertains ORR efficacy And other something in I studies the do we've some threshold from XXX-plus competitors as durable, mid-XX% -- patients. heard setting,

for? in trying Just to looking get be should a sense of terms of what we

modeling then just And question. a as

of regimen to launch you line cancer, think think liver in market of kind you potential before IMbraveXXX monotherapy? the the approval TKI frontline about how the second and up As long opens

Michael Morrissey

imagine, on bit and guidance well. where for relative therapies kind mic in see pass would bar they ASCO the as Yes, with first and the to got to run challenging and question of lot, the Jason, you any other space quantitative and question. a prostate, I'll that expectations as question to We is that provide what question it's Mike. to over from P.J. then GU the up a relative this take others to we general IMbrave

the matures, looking single-agent and and XX and do now as P.J., you -- that and just the show to pass you the regards right cabo -- we're be and others that in judge terms to excited meet In it that the we right, But present second including we're data, do here, before far. aggressively it's imagine. take kind as XX. about for will I that hard can at of of line, so and fact we've us cards, IMbrave Again, or not? patients, got that? more first of to In you in the sure want the expanding cohorts does the bar expectations our the So kind data I'm single-agent then for can data in yourself we get

Patrick Haley

sure. question. Yes, thanks the for Jason,

So as be in patients with I move treatment mentioned, potentially first-line more systemic of into and landscape anti-angiogenic to HCC we care certainly standard there bring of the forward and really combination atezolizumab approved expect first-line ICI that doublet HCC. sort of the

As the then receive would it that's patients soon. and relatively when up progress. far the those gets one approved, have it to And as would be combination obviously, FDA, to that to timing, expect

forecast all it's it's that So to difficult obviously, specifically.

RCC. bit than think, sicker I generally population speaking, a it's HCC, of a

expect more So to half the see -- there. and quickly but ICI really a currently is about than occur monotherapy. have But second-line market it RCC, one wait might little to we're

So expect monotherapy that TKI would marketplace. do portion of expand that we and the into

Operator

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

Silvan Tuerkcan

Congrats some to and prostate that bit when CTLA-X the it I by to and were PFS think reverse? a which of because you on frontline. therapy chance very in just been cancer, the think in -- evolving? have eke maybe more is this have data scripts want any PD-X earlier all, I you setting? PD-X Do second you congrats little little volume great. held there we switch up on think there's you to seen bit more news the that RCC. how patients longer Like, is discussed seen the out to that And slowing could down of or combo Have on year, gears or a post-TKI choice

Patrick Haley

line which and for for all in those seen post-ICI a indicates combo combination certainly What is that second-line patients we're the the the research approximately in market And Silvan. pleased very cabo, there we've the we're This market post-ICI should is setting in question, with. that Thanks seeing majority of really does setting. range mid-XXs second in Yes. get continue to share that CABOMETYX P.J.

beyond sort I prepared in think cabo I of market in remarks that, setting We've seen we've single kind the what first-line referenced stabilize. the of the stabilize digits. share high is seen that the

it's we've setting to through, the the of patients patients flowing see So there now we that as sort And and get market flowing majority in and second-line what would in those we continuing that share are increasing in more through, setting. those is our range. seen overall of mid-XXs anticipate

clinical into second-line really potential the to And the that second for flow-through as think, more is with those setting, where, as of volume, combo the in -- I market is the is share first-line setting line said, market so continue our of as And from share I there care mid-XXs. standard strong post-ICI into grow trials. to the patients mentioned, Gisela cabo

Silvan Tuerkcan

more I on do if compensate you may, question, line changes And potentially on by are a new with with Maybe going generic INLYTA? of speed? you picture X INLYTA when top your think top is big that -- indications track will RCC impact generic? the thinking, XXXX? to what one the just be line And a to you your comfortable to And Mike. Are year-end landscape Great.

Michael Morrissey

isn't INLYTA clear for time matter their completely the both probably LOE line based as So upon as well more composition of patents.

exclusively lung, et in main thyroid. combinations existing expand that single label first-line big in we its is certainly, in of want se outside build either to So those indications like our What is like will And us in and expand prostate, is happening indications reinforce goal liver like that really as to RCC. other focus forward. to to say that focused the agent relative now, the got terms is I cetera, to that cabo focus a time And right into what's speak RCC liver, or franchise So our for is franchise of don't renal, go right? obviously, per lines. I we've again, to and for

Operator

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

Kennen MacKay

what for you looked to needs billion be dependent team you seen brow the give to that, sort of year, seen grow in raising RCC, CheckMate especially given just from $X.X it what to that's that to data, team, of I the the to sales frontline that sense that Mike. this XXXX looked cabo in little some XXXX that was guidance? that on wondering and within decision in understand a the eye XER realize guidance if guidance, in for a wanted drove obviously quite the data help could but us had like order to potential get guidance And earlier Maybe that conservative.

Michael Morrissey

Yes.

XXXX and we scripts the a the framed of in lot of and backtrack -- how XXXX, were the let there's we over people was majority in XXXX. and Exelixis So ASCO last topics, buy and terms around and focuses which time both end IMS both you've story, year me not at clear then the in couple really evolved seen work to The last on of JPMorgan that -- of the XER, all side of terms focus proverbially to beginning that questions was every talked progress a a our year Exelixis' at side about of in been and around so a dramatically focus in today thought the good sell myopic around and on of year and forest the consistently GU. and and it X Friday plethora where ASCO-GI as we has what the around previously the story Gisela or trees business reorient really a last of ending so

what trials in outlined So readouts to new speaks really which again, the look show for think, chart we the maybe out that showed, It's that the a those revenues, like. success efforts successful. a goals XXXX it if XXXX, is and but our sell-side what both DCF. number think, not put that portfolio cabo we're XXXX label-enabling side not could could supported provides, and full ramp enrolling, the to there and the for like around especially of XXXX, The buy [indiscernible] I It's breadth our look picture the clear I potentially and X attempt that. we we indications, XX math that and four of really depth very of

just very the So plan weekly than to value it just more maximize we're signal we're ambitious a be for we was scripts. shareholders. and and our a cabo more to And clear than able patients XER, have program for that of

your JPMorgan complete we frontline remind that about setting. I'd slide you RCC, the that math showed to question the covered frontline regard at that on In

potential and COSMIC-XXX. as single as then XER doublet well from CABOSUN So from the from cabo agent triplet success in revenues

like setting, consolidation look revenues if a provide trials those what sub-streams in, a that's So data. could frontline competitive coming you X number there I reasonable of think different, the of if but that's success for in will,

Kennen MacKay

obviously expand helpful. the win it to Coming XER. That's bit little to of driving sort better are a thinking rate sort it to hazard data, X strikes is massive sort the more me shared just having there? of overall something way, there and GU, be maybe on lower by Or way is a hitting there's use ipi/nivo of in a potential would that's axi/pembro. survival CheckMate a that's ways that on some wondering Maybe ASCO CR you. do team? than I'm survival of despite Merck if success one potentially of another out if what frontline, the potentially efficacious that of obviously, Got the than of competitive, more ratio missing was having I

Michael Morrissey

cabo success statement our our Yes, of that's I from of Certainly, probably for care since ability good have labels. a in to with it's think seen their XER survival a make survival would the be label the line a by competing data has in that obvious of to that thing standard data METEOR. we're having somebody second we've

the that. very see. been right, I that. that's our generate acknowledge competitive that. we'll to that. obviously, an I that's And to with understand And able us ahead chance we've that So running, We of And important But want experiment working of it's maximize think for get embrace don't a data. We be component and partners, to we happening. to

think, of from Beyond kind I we There's there bit different very beyond of data around a could benefits market stretch. that lot now a a But components of of levers a additional that that, and elaborate view. probably of of to lot many have provide we've important we a readout marketing additional research, point questions asked, on how pull. different momentum again, could a the done obvious,

So a the We'll single-agent about broad the in that got to cabo we've got talk have years. be level that case of able very we'll get data, the single-agent data. commercial as And in really drive, care the then, recognition collaborations setting name I used the place data. standard and and we've obviously, momentum both the And appropriate take nivo think, think the in been approach. for of second-line from I strong team the compounds with to could

Operator

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

Lisong Ai

the on for is This Werber. Yaron Leo in Congrats quarter. Ai

the beating long-term potentially this how Just of ASCO the out some that trying seems It the understand still prefer use just of effect data to presented. could the on me they to question GU I'm to the nivo/ipi piggyback the a another landscape of to earlier. physicians coming just terms competitive you question because show in ongoing Also nivo/ipi new earnings want RCC? of the in have durability, threshold mCRPC. on in combo? you or to beat filings? the terms FDA to is What IO/TKI the for of Do

Michael Morrissey

question we about CRPC the and don't answer can the question. part P.J. Why have that then first of talk Gisela

So P.J.?

Patrick Haley

XXX Yes. been sort Leo, did, trial. data mentioned, GU going from years, two nivo/ipi on of they as approved market and you ASCO on thanks for the for now the question. at and have the updated

a with at I sort to give the think and ICI seeing first-line the pem/axi that about market. with the XX%, has really of We're take, to market, as mentioned remarks, in regards I prepared or kind the first-line, nivo/ipi of stabilized. combinations in then XX%

and the vast is So of setting and we in seeing sort gets cabo but I to of patients. there, what second-line I of mentioned, would as cabo think we're a digits those the single high more patients where progressing what more those continue anticipate is majority into

I that's us So there. opportunity think for an

compete. track opportunities With out us and think, reason data history for wait optimism. lots we'll the I the first-line do regards to to But we'll RCC, to a the data. cabo's for with to And of how There's as to record certainly in I to have setting, see that. think said, Mike see figure certainly best

Michael Morrissey

designed go the about obviously, to right now, cabo we're nivo/ipiX. I head-to-head XXX nivo/ipi triplet Yes. can XER with that, talking just really add Maybe is but versus

enrolling generating shot about of We're for So enthusiasm a second excited very here that's a that really we lot globally trial. have quickly.

combination the data, upon very more we're again, And data. able care advancing opportunities for a be committed -- we'll agent great to to we're standard get And as we based got RCC. and move mix all accordingly. So single the of compound we've potential in

about Gisela, So prostate? how

Gisela Schwab

sure. Sure,

population, against So very the second certainly XX%, response you seen the decrease a in see in rate with NHD, patient response treated, backdrop estimated durability are stabilization in was response X.X and maybe who setting, so the mCRPC -- we've like encouraging that of more of of the what the PSA, described than in And or actual benefit. that then is I the months previously example. patients of for our durability

to of set So far, this that with durability generated data respect response. thus encouraging very it's we have

Operator

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

Stephen Willey

post-IO companion strategies an just cancer. those AXL there's K. IO. at and and other think TKI on overlap of currently of stage competitive first, with somewhat curious I you specifically guess, differentiates later being lung from VEGF profile kind that looking cabo, of of targets studies and I evaluated as how are I And think in guess, just in some of the the the some have TKIs cabo And of in to like some one TKIs there kind that those know guess, out I I of other terms kinase as setting?

Michael Morrissey

generally generally not I'm is here, kind of specifically. crack at mean, talking a take our that. -- I'll I lungs Steve, necessarily Yes. view

fact, really of particularly think profile that attractive it makes the it's cabozantinib we combination. the IO totality In

So it's the the of inclusion MET.

permissive I kind immune that think innate well You important an to both has all of we promote this as of family and a and of of an from it think members, view, as populations. I on cell from mentioned component, adaptive environment, AXL, immune the ability into kind TAM its the effect -- quite that's plays VEGFR point cell think is variety immune the

to really then kind really antigen effects to lysis the between cell it's of in settings, aware a the that some the comparison induce overall data direct And add direct presents differentiating. cell, [indiscernible] But profile a immune and just of system, fact has I to tumor think of does I'm totality which TKIs not of that that that's that it the more lot thing. the any cabozantinib. many it's you ability the the If including tumor on

Stephen Willey

sBLA Okay. nivo filed that quick expect on guess, a apply would the That's should to just I that Bristol then for XER of question XER. And fair. the we dosing regimen? QXW

Gisela Schwab

should question don't to a we Bristol-Myers. that course. want their on of Yes, think to that strategies, you I is really speculate ask regulatory No,

Stephen Willey

this maybe follow-up. so future and And might front discussed, I notice, guess, just was line. talk already you this talk can by I but excuse -- I missed being second when that if one driven have you indications, Okay. know both me, I and quick growth then prostate about and help. longer-term about is

of the equation of kind provide comes where Just frontline curious play? you that? part on that any into If can color

Michael Morrissey

Yes, it's Mike. Steve,

MX standpoint over it the are whether that's data to and/or of just NHTs the again, Just last it'd plethora moving population be hormone-sensitive the in upon frame from based up their come few out the line years.

resistant. So versus again, relative first a, castration Symantec's it's about maybe line post as to NHT. the second of it matter Think line, sensitive castration first a

it, whereas think across of gets when at that's levels hormonal different look to line, you're the blah, lines, looking way first the blah, complicated line, probably I sensitivity. second

Operator

next comes the Farmer Markets. line of with BMO from Our question Capital George

George Farmer

whether as like bone ask saw presentation. this at elaborate more responses I'd in trial? all in to about you to prostate lesions any cancer Could the you

Gisela Schwab

course, and present the measurable inclusion. responses to in for X have of on trial, on to include we focused is patients eligibility at disease with Yes, need being RECIST trial the satisfy

could visceral lesions association of tissue the was be soft key of on study. that in that, with or we in are metastases. bone. the so focus And soft focusing are that course, lesions And tissue And either with there

in is at rather be have key described not have we bone. focus on course, those progression in And particular, lesions, response in for the bone bone looking would in scan, than responders that here, study. progressed So and bone but at metastasis Also bone instance. of that we the looking,

Michael Morrissey

that RECIST a from the scan was So if readouts set correlation there back to very standard terms in -- the while that insight very of here something ask had here controversial, And GU entire largely the as momentum the more XXXX, could about assessment years effort ask we So and clinical think the of benefit, the I interesting, in excitement -- the would simple proven of then could whole later we clinical step bone around it use simpler in of enrollment ASCO day, the noncontroversial is readouts. previously, was several X.X learnings trying because clean, response terms and big of focus of into instead certainly, right? will, because response back in get into XXXX, talked And the a response I that any really without to the focus apply and going that terms a you we data both them we again, took clear assessment. give hadn't question population and we very George, we questions a some from across answer. got to us readout think and take comments all to

George Farmer

as And Okay. survival I accelerated believe FDA for focused progression-free then surrogate. the has strategy approval, an regarding also important on

You you hurdle any? study, for What talk if show think? do the Or a lot is you about be response, which DOR duration of do sufficient, need different. you of survival the is progression-free going to sort think in to

Gisela Schwab

cohort this need stress III in rate responses really progression-free usually single-arm now randomized the properly, So or we're at X. those durability we're terms with and testing. talking as the a about evaluate in a approach, study Phase then accelerated Phase done approval and such it's order in to II randomized for in response potential we looking When an pathway, doing a of survival of we're

Operator

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

Paul Choi

prior And monotherapy? as from there combination I I follow-up prostate. PFS? thinking in in question to, if would result or think benchmarks that history had biz then a that helpful you could reference sort for And could you that also be terms where given us cabozantinib's us? of the help a a expectations about landscape comparators have could of maybe of would on devs. the baseline historical particularly just maybe you question sort you on the If Any

Gisela Schwab

as looking now, of rate right ago, So said, response minute are I the we just response. durability a at and

comes. conducting survival, potential a do we'll and Phase around Phase a such about and are accelerated on a we a randomized we're details of progression-free setting course, to this if I the the we evaluation, would talk that that ready I path, talking about time as But when planning think that and successful III to in assumptions so, be initiate a stronger ready much are when And approval we're study. evaluation an you're again, think III study. is in

Paul Choi

the follow of couple nice up, uses next then you coming be cash based we'll a And terms sitting that your Okay. your of pretty up successes pile major on here? Could year-end are guess, at in what of on as maybe on guidance. terms think a of clinical how development, in to cash speak business your you readouts I depending quarters over about

Michael Morrissey

Yes.

both is Paul, now it's with the Mike. going So cabo confidence on and that a a there. right lot lot Obviously, in opportunity progress we of and the have

of multitude both well right, modalities of a of drugs pathways Beyond that we'd that, help portfolio as the again, and like build, diversified as more to targets. obvious, across statement patients a can

So we've got a right in lot on now. discovery going

the in of an the I we the just last around the from years different the science, of and good standpoint the space important scenario as across where that that with additional launching lot and now risk data sources. build right around As like see one you internal target saw we've is if challenge probably the year build kind looking the onerous. the think from companies is be we doing new the move do as to work And would year How forward value? well to where a of they release we in of assets a board, transactions, the of variety we and/or INDs the that upside? transactions do most And over at collaborative is approval both this few opportunity? variety involved? of those drugs Where the clinical year, commercial understand collaborations -- can conviction of latter -- can to you when and/or arguably We're X and this press a somewhat the some up a with got have began around

So a based have build board, internal diversified to lot a as success upon both we're external the look, that company looking a from sources. across we as is well offering, of and

we're have I will that -- the and we're we for But can at the that sure the assets that the for is spending right time and deal the that work focus doing make the So assets for money the needle right place discipline intrinsically, think in doing in right of for believe get the the right And future. really continue. the right to right amount we to price. patients us move

Operator

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

Jeff Hung

talked help build You've the then about HCC. line to the for was RCC next weeks, in cabo that that year out how have will where years HCC And have market a approved was you'd and been ago second market. in few

be far that second you needs can you've for line to And additional So comment think out come you building on what HCC? cabo how market work done? in on

Patrick Haley

progress you as our is P.J., the -- the approximately a this pleased the certainly on mentioned, we've year thanks Jeff. Yes, with in market. for question, We're made

more said it TKI combinations into us, that always only speak, what encouraging. so about not the first sort variety upfront. that in of the we're market atezo/bev of I be a being potential plus built moving space, are which #X to in treatment there think We setting really and line funnel, -- the is I the second mentioned, is I to the oncology And we've catalyst setting could first patients of line. different take is sort bring think our but the in would as medical going And the

the on certainly and look the about in we in landscape. to think as then more forward we're cusp excited similar RCC, I study our XXX of So potential change there, HCC

more there. come So to

Jeff Hung

from Great. you'd cabo? talk may you remind over And any properties And highlight different specific and think advantageous you how then XLXXX cabo? us can that be about it's

Michael Morrissey

at pharmacology that previously. happy future about said one in that talk haven't that of the plan to that I'll went considerations the And Again, year. a We that Yes, take year. molecule lot sometime question. this be about and we into to this meeting the least design certainly medical

helping about we and get So work that the value and certainly when us stay to that that both into went we'll is, share be talk is, that the then behind where the Once tuned next-gen bring. thinking slot, on that. this cabo could that happy understand we'll that

Operator

time. further no at this showing questions I'm

the so your Susan for over to host Ms. call I'd turn And today, like Hubbard? to Hubbard.

Susan Hubbard

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

Operator

concludes and you this conference. Ladies gentlemen, today's Thank for participating.

wonderful Everyone, disconnect. now may You have a day.

Exelixis (EXEL) 25 Feb 202019 Q4 Earnings call transcript