Exelixis (EXEL) 18 Feb 222021 Q4 Earnings call transcript

Company Profile

Participants

Susan Hubbard	Executive Vice President of Public Affairs & Investor Relations
Mike Morrissey	President & Chief Executive Officer
Chris Senner	Chief Financial Officer
P.J. Haley	Executive Vice President of Commercial
Vicki Goodman	Chief Medical Officer
Peter Lamb	Chief Scientific Officer
Chi Fong	Bank of America
Michael Schmidt	Guggenheim
Andy Hsieh	William Blair
Jay Olson	Oppenheimer
Mike King	H.C. Wainright
Gabe Daoud	Cowen
Do Kim	Piper Sandler
Peter Lawson	Barclays
Kennen MacKay	RBC Capital Markets
Jeff Hung	Morgan Stanley
Chris Shibutani	Goldman Sachs
Stephen Willey	Stifel

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Fourth Quarter and Full Year 2021 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, XXXX all joining for results Thank fourth thank quarter for Exelixis call. year XXXX us conference you, you and financial full

fourth and are Joining our today's Haley, Chief XXXX Peter will our our quarter of who Chief Mike Chief CEO; President P.J. and together Vice Scientific progress Vicki Morrissey, Financial me Officer, XX, Officer; Chris call for December review Lamb, our XXXX. Commercial; on Executive Medical our Senner, and the President ended our Goodman, Officer;

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

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

Mike Morrissey

and we'll full Susan, on Exelixis as to you, joining short and a and All thanks components today. right. growing continue RCC XXXX JPMorgan today in include: its topics to net XXXX of at for remarks continues and in we we the in discovery grow a maintained in of product a enterprise, a the the billion portfolio year all us Thank to call the therapies CABOMETYX quarter our growth pipeline recently XX% Key threshold first, compared for had across today, prepared programs. investment fourth everyone strong advance of CABOMETYX focus update and keep as oncology. and status XXXX. We'll to our the surpassed start the TKI gave for business grow January. clinical fuel the and detailed next-generation diversified cabozantinib our Conference leading revenue Healthcare to the business $X U.S. advancing as XXXX, on with year-over-year

a expect scope numerous development, program of including now and complementing XLXXX, team, growth with development XBXXX line in portfolio be initiation cabo led significant for indications and the the Goodman, results focus potential in a build-out East, by of Second, our XLXXX, Vicki breadth grow we our beyond and XLXXX. and pipeline with expected year pivotal with molecules important expanding trial on advancing top Alameda. XXXX and our stature the Exelixis extensive depth XXXX and could of to size, for

of up new this to candidates finally, efforts across biologic and five discovery and small core and selection a in remain XXXX. of with strategy. rapid internal molecule advance continues to network collaborative Business of development pace, a drug both Third a expected our development platforms at activities component

an will fourth an please potential fourth call over quarter. I'll where Chris, list quarter hour corporate see now both achieved quarter ago who a the perspective. from key of for release and results. our in to turn forward, the commercial financial our clinical additional results year bring financial review we XXXX have to including that, Chris? and extensive expect milestones full issued and conviction collaborations the for increased With assets clinical our We press

Chris Senner

Mike. Thanks

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

achievement included to net $XXX.X fourth Our third trade relatively when Total quarter over revenues the Ipsen flat of million hand in Genentech. in XXXX. collaboration consecutive Takeda, in remained of four on Exelixis related XXXX, recorded connection primarily million from territory the In quarters. of its from and revenues, a the Ipsen, sales million milestone compared with due inventory $XXX weeks payment $XXX license in quarter also

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

year the financial guidance, JPMorgan which previewed Conference January. full at our in to XXXX was Turning

call guidance, to over the $X.XXX turn billion guidance We are can slide The which items With on that, be P.J. year full revenues and to in XXXX remaining including now total range the of $X.XXX be expected XX. found I'll billion. is financial

P.J. Haley

surpassing by CABOMETYX in year in Chris. cabozantinib primarily a $X you, combination a XXXX of driven XXXX, approval in reached of nivolumab with billion XXXX. of The January transformative RCC revenue. net now Thank in US was significant franchise, becoming in first-line for the have at for TKI the milestone resulted prescribed execute in and level a high RCC. one prescriptions, this has CABOMETYX Furthermore, CABOMETYX the or consecutive quarters. team to TRx, number five CABOMETYX grown product total continues

Additionally, the a in cancer thyroid DTC, received or to is launch off approval in of start. CABOMETYX September, differentiated FDA strong which

for and XXXX TRx. trends Taken remained Year-over-year the TRx. NRx and XX% for XXXX. for strength and business well of QX, XX% in in QX together, growth the position for of growth both cabo Prescription in momentum the strong NRx was

the with combination on changing is mix progresses, launch success of the CABOMETYX the RCC. in CABOMETYX As in nivolumab patients of

first-line the CABOMETYX. XER years combination to Given for duration clinical approximately we X.X anticipate significantly patients study, CheckMate more, from these receive therapy treatment thus for driving or data the longer a

encouraged a further in XXXX. is we relative combination new see data, that indication that at uptake dose of starts in patient are the fact in amount This XXXX our the We robust. doubling the of setting is the to by the XX-milligram first-line

XX%. usage quarter share by CABOMETYX market share Votrient first-line the market market Turning RCC and to the in LENVIMA, TRx TKI basket driven CABOMETYX, quarter INLYTA, combination XXXX in This in with setting. reaching every fourth of increased Sutent, is growth the

Furthermore, continued seen taken of combination we clinical As pleased the are competitive positive. in competitive, haven't with this in line of growth market risk we first-line RCC this settings We our first in impact practice setting. in the with have business broad all market CABOMETYX for been the across date nivolumab has prescriber we on discussed share. believe previously, is and momentum and Uptake significant performance the the and together is groups in experience CABOMETYX XXXX. to positions with very

settings. other to Turning

the TKI strong was our which cabo stable for previously market new are starts in strong becoming to with approved medical of no There QX, patient in we trend care setting. our in this for first need, pleased expectations. DTC, were business patients believe launch. treated RCC continues in in the a setting a standard with saw was significant in And this second-line to unmet QX remained pleased be are we line. and with We share With we indication, QX. HCC, therapies exceeded and and we this line most of immunotherapy the population the patient CABOMETYX regards in second-line the stable that quickly second are In prescribed

fifth for adds to help that indication body in to the severe CABOMETYX this are data enables proud and the cancer. with of more We Exelixis label patients

cycle begin to life look need five indications for numerous Looking top they therapies. to readouts more having line as cabozantinib, data XXXX. bring of We and in current data approval expansion the beyond, pending the opportunity, to the forward opportunities we're for to in planning CABOMETYX patients US have

to I'll bring the day to Our maximize the continue eligible to franchise highly focused motivated benefit team build and turn as over compete patients CABOMETYX every And we potential. remains of with Vicki. that, to to the and call all

Vicki Goodman

Thanks, Prior be Chief XX Drug Good myself. pharma oncology introduce late-stage with great to at was and with where January, increasing Area after for am I at afternoon. in like companies, industry. medical in Exelixis, years now at years Officer. P.J. X.X of recently experience Head oncologist and three subsequently It's I as Administration spent the months moment most development, Medical XX to today, joined take here government hematologist to global I in joining I a drug in both to I'd in responsibility Exelixis and Food a oncology. roles Merck, early Therapeutic nearly

across developed as East to East, drugs Today, in cover our including to immuno-oncology agents Phase on Exelixis conjugates well indications. drug milestones and as career, drug our IND biologics, expansion implementing as my all will successful organizational designing progress first and from and well to our towards progress small filings both have pipeline I development, leading antibody upcoming and phases the of During registrational including molecule approvals inhibitors industry for major kinase Xs studies XXXX. as I Coast, additional

seek to King on identified that I'm Philadelphia announced we the Philadelphia intend we presence ready in Jersey our Coast, suburbs the short-term a much talent both on office Philadelphia space. to coasts and accessible happy in we for location development in of access the biopharma New to Central base. Prussia, Greater of Pennsylvania and now convenient support of we early western talent move develop a have organization. area, as in and the and January, As expanding East to report specifically

immediately. the for medical development We King initiate affairs added efforts intend option roles within have recruitment and the to Prussia location organization as open of majority of also the and an

Turning pipeline, now to an trials. with beginning on registrational update our our cabozantinib

in are X evaluating the of half year. carcinoma year. readouts atezolizumab primary experienced and survival primary intermediate carcinoma, nivolumab PD-X with cabozantinib of COSMIC-XXX, in renal progression-free is renal for endpoint in on the interim readout risk expected track and half the lung An in poor this combination first for ipilimumab CONTACT-XX are CONTACT-XX three cell cell with XXXX. and respectively, in readout We non-small and cell second in for endpoint of Phase expected combination cancer

overall for and readout cancer X Phase final if occur survival in in is study, appropriate. the we enrollment complete shortly prostate combination atezolizumab hepatocellular COSMIC-XXX quarter, our Additionally, this filings anticipate metastatic regulatory in to this with year. castrate-resistant carcinoma in CONTACT-XX, thereafter, later expected will

opportunities next-generation initiated We our AXL, additional is study explored XLXXX, recently checkpoint immuno-oncology continue continue inhibitors combination with make studies. to kinase being combination inhibitor tyrosine progressing and combinations genitourinary explore towards We progress in IO malignancies agents. to on in nivolumab-based on and potential novel and and MER VEGFR combination is a pipeline several molecules. with our dosing registrational MET,

Phase determination and first ongoing microsatellite comes to second of comparison were of year. stable quarter demonstrated A is which promising been inhibitor, cabozantinib dose. into which agent move study factor, both January, first current regorafenib, initiated in escalation activity will XLXXX, is of I pathway of X bleeding of the antibody CDKX supporting and the without third-line cancer, two the expected in ASCO Data drug the interfering preclinical historical in expansion tolerated presented XBXXX, be events in this single targets study Thus planned coagulation cancer Phase in far, with our standard conjugate, Phase from it II of combination colorectal dose GI at cohorts after observed. escalation. our and care. controls studies models in well dose tissue this oral colorectal Our has no completion of to with and

study Finally, site an expected in activation this is initiation currently IND and with XLXXX has quarter. first approved

our and with of XBXXX, I to half expect Exelixis for medical this in the Phase We pipeline. talented I'm conferences team present clinical XLXXX, progress updates XLXXX the to we excited to very year. as be second continue at working

molecule discovery improve small with well us to Our patients novel turn clinical well as continue current to to ongoing areas a positions that, for as unmet I'll biotherapeutic cancer. address need update. the lives and pipeline With mechanisms, of discovery early over of efforts targeting Peter it to

Peter Lamb

a I Thank pipeline. the am of Vicki. you, pleased preclinical Exelixis quick to provide overview

multiple We with aim the our with X with ongoing, XXXX. process programs development up both have and to in collaborators compounds into over preclinical internally of programs XX in advancing

mix a As which you'll see and the the in slide, evolving see molecules preclinical of of reflective the biotherapeutics, balanced is pipeline pipeline how is the future. in small clinical pipeline we

from free Pag type types through As PK with and molecule. point development. antibody Vicki is observed preclinical Phase intact compound different this T MOAs This different our comment broadly seen we're we is we us and to variety upon our of tissue targeting network PDX wide develop an sensitivity damaging the and we've to did us is DNA just internally been payloads XBXXX. profile high overexpressed it to the the ADCs different such funded trial to started each for has additional obtained as payloads, the is Hence, tumors on show to so development tumor is payload. stable Phase ADC our we've quick will tumor to ADC of ADC A in free deal factor allow This work preclinically, ADCs count. additional of low gives controlled linker, advancing the that neck match far recent including The most of indicating antigen about same circulating and ratio Ultimately, link ADC first depending multiple and compelling recent tumors, it generated the non-small in Tissue conjugation reduces head a and believe levels date. commented, collaborators. underlying drug antibody linker XBXXX cell coupled and in targets efficacy proprietary carcinomas the Smart models. a a Iconic through to allows excellent a also data factor stable and technology payload, particularly levels which of gastric utilizes by XBXXX lung, that based homogeneous oncofetal I, MMAE. multiple payload. that clinical and site-specific both I that we breast, solid highly is with The and overexpressed encouraged a antibody of is Catalent to we've which with starting solid

XBXXX, back and We're an yield with technologies has is which suitable against in with consistent or to meeting preclinical a the in now next-generation moved ADCs, approach contemporary preclinical XBXXX publishing that, call philosophy And year I'll to is IND behind data with later this Our major incorporating XXXX. journal. over the Mike. turn advance development a directed ADC could XBXXX anticipating well-documented targets. into at

Mike Morrissey

right. All Thanks, Peter.

pipeline, on As across activities. in our development to clinical our all heard our progress year today, XXXX, continued business commercial you with the of facets team the call quarter execute full in fourth significant across and

multiple XXXX, drivers us, enter the a our cancer to importantly, potential most business of about the the employees now pandemic, side, office recent thank Omicron the want together the back the in navigating the efforts during I team challenges side surge. in collective for including many by their working significant individual many in forward patients. ahead help to more we we're put for growth excited Exelixis Exelixis and the and With position move As to

forward during scale, planned drive patients highlighted my and a become have presentation, growing Exelixis operations serve and JPM to begin vision, on multi-product our recent East to expand with we I to As enterprise our resources to global a the your progress support future. continued you cancer Thank call now the step on Exelixis. our and open for in in to Coast in We're happy journey. for We presence updating first that you interest to questions. the look as the

Operator

of [Operator comes Our from Bank first Jason you. Instructions] question the Thank with Gerberry America.

line is Your open.

Q –Chi Fong

expected on will should evening, taking initial that. the you EXEL top Good level the How think This questions. level then about on in is disclosure line Jason. line couple for after question everyone. Thanks. of Thanks Do think follow-ups the half. of XXX? the for details the XER indicator just is COSMIC-XXX, good from on Hi. data Chi result our of is Maybe for provide first results? I investors pretty top have a And first

Mike Morrissey

take you do to Vicki, one? want that Hey,

Vicki Goodman

Happy Sure. to.

So release, year. terms that press our I for a top then meeting the in results it our we in line medical would this be of anticipate will consistent the with practice, hold and top report will prior line later full

Q –Chi Fong

data for feature initial And of half year, a bleeding highlight this differentiating drug. potential on the it. and XBXXX this Got company second as has safety

initial data exposure to the profile? sufficient do curious, treatment characterize aspect the half, that of will the second fully believe in I'm the of So -- offer duration disclosure or XXX you

Vicki Goodman

Yes.

with perspective, doesn't vector that coagulation it the particular, So binding tissue excited we've from of preclinical a we’re XBXXX, the about of opportunity the interfere seen in because to pathway.

will And it coagulation so, with interfere believe the we don't extrinsic pathway.

-- we this in We at remain dose point. escalation are

As seen plan, I we a the we in profile meeting at later will when to of year. events. my seen any safety And bleeding we course, not medical we've have this yet mentioned remarks, disclose presented that

Q –Chi Fong

the that would looking Got it. case, can patents litigation on with on MSN patent stay? going provide the one are And curious to Is and the you new the just the Maybe, last status logo? case? front. this you What's the be extent parties Teva there Any on consolidate what's recent to helpful. color where can, the situation a litigation given me, from

Mike Morrissey

question. Yes, hey it's for Mike. Thanks the

core here pretty sure and Jason, have the I'm closely. involved think are you I been docket tracking

that, You've have. on others written

fun been to that's So, read.

the happening beyond continue facts appropriate opining more and have well. pretty from there to see, as what's for emerges information guys to the covered, in the avoid think, that are what's I court. really I we'll per docket, speak when the docket facts to all You on the want

Chi Fong

Thanks so much.

Susan Hubbard

Thank you, Chi.

Operator

Thank you.

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

Your line open. is

Michael Schmidt

for guys. Hey had questions. for I one Thanks just taking one and my for P.J. Peter.

to line market in the and in grow. out line at share among CABOMETYX TKIs is first one first this second share nice The you is break see respectively? point what RCC, Can your

P.J. Haley

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

So, said with regard we is just to that, reiterate I'll of what previously. what do kind

In of have in second post-IO line share starting the certainly there, setting. majority share we terms the of

I share, specific the said say prepared there for we've think therapy two-thirds we momentum. is the so at. business I significant could there's who first as in certainly haven't driving we that you would has stable. as out And the around been of disclosed first-line kind look what's that's growth IO in had some What that's then been of previously. line And our the and of the rest mentioned received market I really or previously, patients numbers remarks, recently, our

So, as increasing TKI by from uptake. XX% our you XX%, look XXXX all the share almost over being year of market that's driven to at essentially first-line

the as very resonating the actually and we're got extremely San quality well the physicians. overall here GU ASCO with excited. Francisco, oncologists, that survival, terms So, of we've messaging toxicity with well we're balance it's data in of life data our as weekend data really be the This profile, the resonating going to as pleased well And meeting in are live. our with of and

many the pandemic. be that to as KOLs significant which really we in opportunity our presence haven't obviously in much So, to the be had forward will do as will fantastic looking really of meeting person, which and there, with

So, we're our with pleased very position.

XXXX. momentum great As I have into we heading think I mentioned, really

Michael Schmidt

Storm early-stage what and around then -- just exciting target, I of collaboration. that Therapeutics perhaps thank the you. Thank then yes, curious if on that. could you. And Peter. insights to particular one you And about question This I first around some had was the any Yes. wondering hear I'd really a additional specifically And activities, be is technology just comment company's the makes for

Peter Lamb

a discovery. speak a providing approach of small expertise complementary certainly absolutely. that. to with fits to if much look sense SH and adenosine I'd which terms internal lot the we or kind I'd target, and with as fits leading Generally at very say, collaboration of strong significant available Storm CRISPR-based Yes, deaminase we're to still the small that. be that ADARX. discovery philosophy with Obviously, complement been us But last growing target the based those happy in that's in collaborations have screens. into and a partnerships our The of you discovery come with over oncology very or couple a insight overall speaking, molecule or very molecule to respect that's Storm out target in and took effort. outside number happy makes publicly in is years, done of as hit to is of ADARX a

would That's death. now. probably restrain an So I it a probably tumors or dependent help interferon-mediated about hot to that activity so to ongoing what to be in clear target cell of XX% right call very up upon oncology essentially ADARX becomes are

So that's priority of it. the behind some basic

screen target. been RNA Storm's specifically progress in an it's ADARX made radar a the I of kind interesting methyltransferase the necessary platform work So on approach good They've effective not prosecute generally, done will together. which of biology for fair se. both a target. aside, enabling a just as experts in to on of We're of but a to and amount that also while putting kind epigenetics to our is lead platform. put terms whole a on nontrivial say on also structural an assays they've is platform And an methyltransferases per scheme, optimization together

with So than rather would internally. all trying the our very work was rebuild to view in program them it to start area jump a us much that

to collaboration. it it's excited for running. the in off So and days and it have be early We're certainly

on we'll hope to at progress in update So the be able some point future. I

Michael Schmidt

you. Thank it. interesting. Super Appreciate

Operator

Thank you.

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

open. is Your line

Andy Hsieh

my Great. Thanks for question. taking

have two I really ones. quick three, So

little during the kind Second maybe maybe these you've scheme think your So how a the waves should contribution you in the also one, things? with Vicki. modeling current grand we for maybe QX. the P.J., of just I'm in about contraction, wondering see maybe normalization that DTC what standpoint, just bit for seen lastly Chris, from sometimes is talked one of think quarter? a maybe of I per you status times market. And of And RCC about

and In from I'm just about to given wondering a COSMIC-XXX, there terms just thinking Mike XLXXX, And previously think I potentially positioning that in the is said if has hepatitis learnings maximum set in also about this HCC. of a C-driven success? the the for and/or and really HCC way patients potentially a trial B-driven hepatitis of for just future you. to probability Thank minimum maximize

P.J. Haley

Andy, This I'll P.J. thanks question. Great. for first I'll actually -- the two. is take the

So starting is with in DTC really pleased anticipated, prepared we're we which setting. It's we and in you patients that area kind remarks, it's than And as The the the PFS significant care about therapy fast And a becoming saw trial, start believe I off need. of a at duration, gratifying. in standard of to that how we're with the thinking towards XXX an really unmet opportunity, launch. months. XX if we're of look around QX, we in my mentioned certainly, starting more

of believe nice peak. opportunity thinking thinking kind at we a about million, that or give it's $XXX duration about So at we're there's as take, therapy of we're level, high a

about of kind thinking that's how So we're DTC.

the become ebbs second So in way of IO/TKIs pandemic, to in to would are as we we're drive and duration we've the as combinations in of and terms data up expect we're stabilized to the and of some prevalent, saw prescription therapy close of and the year. really just for become over flows therapy. quarters when view of I'll the there, TKI IO/TKI I turn therapy more for with over the question. last think to last expect expand market, that time. grow continuing but and in a more growth patients to at more I in XXXX to Obviously, continues over -- maybe We would goes terms But is of the see setting looking regards combination longer what CABOMETYX. continue those your we talking third there a to from growth last overall market receiving therapy, those I'd IQVIA as second parallel say stable becoming that beyond about of I combinations see market just XX% potentially in to TKIs, of duration XER frontline of one they seeing which the half really general, of the how provide to first-line in to for of question, few year. did the see Vicki it that And more

Vicki Goodman

you. Thank Yeah.

So different we're of liver excited tumor for has etiologies seen about and cabozantinib activity. we different that opportunity in that point XLXXX the other made, tumors HCC types, you many the different To build development checkpoint disease VEGF be account and HCC where including have learning’s taking those therapies, all may hepatocellular carcinoma. demonstrated respond differently in into including XLXXX program to therapies. and inhibitors, directed And we of we'll for as the

Andy Hsieh

much. Got it. you That’s so helpful. Thank very

Vicki Goodman

Thanks Andy. Yeah.

Operator

Thank you.

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

is open. line Your

Jay Olson

plans? And results, to planning XXX you're in -- the how in see a pembro talk about nivo setting? compares Can on year much initiate various getting follow-up you you just for real-world opportunities runway taking to pivotal cabo feedback XXX, with for first-line development you plus additional lenvatinib prioritize XXX? how any questions. for Thank for on are you the And study pivotal plus a CRC, the from RCC a setting? on growth thank in initiation and of Congrats And clinical the studies and you clinicians the you. maybe this your how cabo then plus nivo would in

P.J. Haley

the I'll This for is Thanks first P.J. the question. there. part Okay. take

due terms reason prescriptions in our CABOMETYX. robust XXXX anticipating for than won't in in guidance, majority about think think combination -- I growth, quantify I outside say for growth it the I demand we we're first-line I other our to with underlying to is obviously So growth of look some that earlier, at majority that of of the of as growth growth. nivolumab. of that say, is you if And DTC that's that, CABOMETYX mentioned But really and usage the

year continue earlier, therapy mentioned of market. I duration the the just will a on As

Now so drive that's going to continue growth. to

continue to opportunity patients to more the have we and believe we get and therapy. forward, new Going on more

the the and and I safety positive the of of with strength our of feedback and the boards prescribers efficacy we data the positive. get, either will of physician through team, the the our or with experience execution resonating view think kind as is impression. in hands combination strong of Given say that, a market of very that story They research advisory and their balance I

question. I that also augment So our Vicki I'll for continue second it And utilization then will going turn the to over think to forward.

Vicki Goodman

P.J.. Thanks,

We're we're regimens, for looking of XXX. COSMIC-XXX, for evaluating a looking beyond STELLAR-XXX currently the inform will including we're in finding cabozantinib action So combination to various of help at build a signal few our novel and trial XLXXX. robust program plans mechanisms study XXX. first pivotal that

have earlier, I kinase similar As very mentioned profile. they a

we cohorts to believe in including seen there's opportunity with from we've develop that various where activity cabozantinib, of XXX So places an COSMIC-XXX.

And help will out CRC read already plans moving trial into pivotal the for so beyond inform trials those cohorts, as our we've XXX with they that announced.

Jay Olson

Okay, Thank very much. great. you

Vicki Goodman

Thanks Jay.

Operator

Thank you.

line King H.C. question Our the comes Wainright. next of Mike from with

open. line is Your

Mike King

say, of with more I'm And starting is question. question curious maybe Thanks guys. taking you in regimen triple? I'd about those or use cabo as the what first-line Jay's add-on if Do a up I on to in are the therapy conjunction just follow color a that checkpoint? proportion wanted for just use have Hey with on the RCC.

P.J. Haley

Mike, is P.J.. this Yes,

of would in over data with a got CABOSUN first little say of combination is first the in shift doublet data our was in in that. previously, usage combination CABOMETYX seen we oncologists of setting, really that of have sort have been the So monotherapy. for approved label, a nivolumab and the utilization we've had I ago that strength receptive guess When the first-line the line, highly which year I the CABOMETYX to given of majority we with line in the what

that's really, seeing in So setting regards CABOMETYX' the of primarily to doublet. we're utilization what first-line with the

first for nivo as forward expand cabo/nivo lot be setting. potentially that think just we line. XXX, study a in think first-line in that of that I positive now the There's think that and ipi, should opportunity combination certainly I the receive ipi do of terms the will of patients CABOMETYX to a in market

and We to risk study profile -- should I to that an think can there's with be benefit if to positive. get So patients. that those patients add CABOMETYX an opportunity appropriate more more

that for frame you. helps hopefully that So

Mike King

maybe about and combo think one Hasn't a Great. cell that. I'm while. development anti-VEGF in non-small of been And how CONTACT-XX, Vicki. ought I a cabo we wondering for On of appreciate the to atezo. just in

widely Just here. thinking about that hasn't how upside that discussed been provide might some really

Vicki Goodman

Thank you Yes. the for question.

Again, an a a outcomes. or minus good is CONTACT-XX care a unmet It's atezolizumab standard an and lot therapy, year. area primary a treatment remains with right, with non-small which particularly underserved not survival, really cabozantinib of checkpoint cell after is of inhibitor, on of overall need. versus cancer chemotherapy. So, lung here a with combination plus in docetaxel, The this interim later analysis endpoint docetaxel of survival readout sometime an with we're overall expecting old is

patients. is we need so benefit an unmet demonstrate for really these opportunity area believe of high this And further to an and

year. this to forward readout that looking we're later So

Mike King

Appreciate much. so it. Thanks

Susan Hubbard

You bet, Mike. Thank you.

Operator

you. Thank

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

is line open. Your

Gabe Daoud

This Gabe much. on for very Yaron. Thanks is

So are my on questions pipeline. the

XLXXX, monotherapy the can please detail, that confidence the kind touched gives maybe Do what multiple activity cohorts could in program for a pivotal little of of data Thank into early third-line you then, to the XLXXX in you. expect Vicki some a bit, specifically. see go versus objective on regorafenib. little CRC, with the multiple study data be half, to -- but expect second CDKX there you First, Will cohorts? And responses? we from data dose for you discuss more

Vicki Goodman

Sure. Thanks question. the for

with the dose in We escalation escalation Right conference medical year. and sometime cohorts first. anticipate XXX So dose we're later be this the the anticipate. will we I'll presented that's at what take XXX now,

data, updates be early still look also fairly will that will and we in XXXX. clinical additional forward to on these So molecule

Regarding XXX. your question on planned the cancer colorectal X Phase -- for X Phase in

a is third-line study colorectal this patients So stable cancer. metastatic microsatellite with in

cohort GI, Camila that an of earlier are them We were remarks. I supporting So and documented was studies two data that a come mentioned study presented they failed randomizing acquiring other One was trial other either the were mutation to from status or COSMIC-XXX with in RAS investigator-sponsored called atezolizumab this and regorafenib. ASCO therapies. to study. basically at as my The XLXXX the

XX%. type. what known RAS quickly patients those But wild The of who or I MSI was was high run in cancer for are COSMIC-XXX you. a results combination we can patients some no rate through cohort, That So, overall was response rate with who colorectal in response in had saw atezolizumab XX% DMMR.

So, with RAS a the patients in we XX% this type, combo wild a to durvalumab similar did overall rate, stable in again, to was plan population overall response But in also the was population a what Likewise, better response study microsatellite in XXX. patients. Camila, rate and XX%. in

of place we're So, believe these see to as the patient likely is population. we benefit most findings, result wild-type that a the

And RAS will focused primary so overall on wild the be type. survival endpoint

And X%. also add However, at the look of point we I'll overall. reference, about typical a response regorafenib population rate the for maybe is just just will

Gabe Daoud

Great. you. Thank

Operator

Thank you.

Our next Jefferies. Akash question with comes Tewari from

is line open. Your

Unidentified Analyst

our Thanks questions. This Akash. much is Amy for on for so taking

rate? route wanted channel your of year. seen real-world run you XXXX this inventory? the end seasonality in cabo $X.XXX Just provide run rate so cabo expectations With any of duration Are guidance revenue prior RCC? at cabo any on of have Additionally, of contextualize with is Thanks your for to median $X.X still billion billion in midpoint. treatment a in color much. comfortable there demand this achieving cabo you can And you by

Chris Senner

Yes. Thanks question, for the Amy.

throughout relatively demand I'll prepared on perspective, as year QX year. weeks inventory stayed an in line during with the from all was So, from my perspective, But on flat I the QX. touched inventory flat demand hand remarks, actually growing that it start increased. one. It it has versus a but been the with in

but -- is part question that's first The the seasonality, The inventory. of sorry. X.X

Yes, run we the I to it think on getting you range So $X.X that get mean, as about of rate, exit year. billion if we rate does you into where $X.X billion guided, the a of run

P.J. Haley

And in CABOMETYX take we in we've of -- the combination in regards for on duration about this P.J. that With were just year. kind a -- to to just the thoughts market is the therapy our that of -- sorry, been Great. question. it's first-line setting,

year and trial, in or we or So PFS. half, a take give of more the see

look I I of mentioned, really to believe would XER. back thus early that we a we're as to to expecting significant what we're growth But able the that's a So, certainly significant with just seeing pleased from we're it's duration see have for And driver us. say be far.

Unidentified Analyst

Great. Thank you so much.

Susan Hubbard

Thank you, Amy.

Operator

Thank you.

line Kim next Sandler. comes Do question Our the with of Piper from

Your open. line is

Do Kim

for taking questions. Hi. my Thanks

survival First, your hazard on provide maybe powered hoping the median the I for expected or that and control ratio study is to what frame expectation the could the CONTACT-XX. us was arm for you show?

Vicki Goodman

Yes.

really great there aren't So second-line. setting in this of data

the continued So as the and therapy standard there an of I/O second-line used a platinum speaking, the received generally to data. therapy in patients because it following changed, great was care who has and isn't in -- has second-line Docetaxel therapy be platinum past is combination.

with for to substantial past, than who speak the cabo survivals And obviously, can clinical fact median in for in effect the cancer, were less a really substantially combination. the we're here patients I that the in had respect a the second-line. that lung atezo than So shorter metastatic year shooting lung and cancer the to first-line

data we'll analysis year. overall of interim so survival And this later again, first from the an see

Do Kim

question sales. another have for seasonality I And on cabo Thanks. Okay.

first to or manage do XXXX, those should considering seem As sales offset cabo, through to factors? back to your we at the due now, to impact. seeing gross go potential Looking start this quarter Is factors? you seasonality we we reimbursement you look something typical start to any for the net should

Mike Morrissey

It's Probably Hey, wise be Do, in QX. to guidance QX the us of middle giving not for Mike.

on doing. and numbers support setting. that have are team we again, benefits on feel to continue we the really but a QX, -- the we based fortuitous, have we're with ASCO And be both but based stay good the about in timing in brand stay going academic The strong like is combination on data how GU to So out the and in May. QX call have, educate the of the able tuned We to the to when feel tuned. we the somewhat there, call that physicians community of lot

Do Kim

you last inhibitor? expecting resistance, for inhibitor the or are question And overcoming are with lymphomas to it a perform how that Is the you opportunity see aggressive inhibitor MALT-X for have in BTK about XLXXX, Understood. better thinking NHL? BTK drug T-cell than primarily

Peter Lamb

Peter, It's take me let one. Yes. that

active, is an are I BTK where itself, inhibitors correctly The in activity terms BTK MALT-X believe activation in in There inhibitors BTK B-cell MALTX are including there think of pathway, you where CONTACT of of are have the interest. also subsets of other not of lymphoma, action inhibiting where downstream is resistance a area for lymphoma of XXX. where clearly specifically, setting BTK wouldn't. mutations could significant mechanism BCL identified XXX the car we

kind examined. two opportunities are initial those stage be of or that So could stage early

Do Kim

Great. my Thank you. question, taking Thanks and on for congrats quarter. the

Vicki Goodman

Do. you Thank

Operator

Thank you.

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

Your line is open.

Peter Lawson

for that questions. the should year? Great. think And later Thank you. the be success? Thanks XLXXX, taking in for CTKX what data what looking we inhibitor, should On this in we about as

Mike Morrissey

the year, you Peter, later probably go what early Yeah. the upon and there it's It's we do of can probably how if that from that through think present opining But it's give like premature in to XXX early Peter, again, and we to give say year. and pretty would is update few you months months in presentation in guidance. It's the we'll a on biology now. when level Mike. have basic fulsome words? our to see we and you different. start do you sense a Peter, might want a

Peter Lamb

Sure, yes.

if you and CDK been interesting advance I to trying for have of limited another So, probably CDK people history the look years. a way of now, sort think pretty inhibitors development, right stage XX at in we're one

clinical into those two family, fall, both upstream of in X, speaking, of regulation. cell CDK If CDKX clearly also and entry controlling in really and broadly have and has you a look And proof-of-concept the CDKs CDKs involved very buckets. CDKX/X, are X X we they primarily then obviously It's mechanism. that are role There at cell where for cycle that CDKX/X the into phases various cycle. that group. into falls X, clearly

then addition other least add CDKX ovarian well. to at in just its breast So combination or both other just as or enhances transcription inhibitor dependent opportunities triple-negative ER, opportunities. being there opportunities tumors RNA for directly interesting of those tumor from types, a such resistance possible are of in regulatory role, Then lot CDKX one and CDK AR I would so in as CDKX/X the inhibitor. also

terms obviously have profile what's is. that. we of think some CDKX to We first be characteristics and view an XLXXX XLXXX and of of of our In need the important inhibitor, a fits the selective profile ideal highly of

flexibility maximal cleared therapeutic think I of preclinical XLXXX dosing covalent best going the is plasma action of models, in circulation to rapidly. index. out really give chance have at want to out but optimizing a very the of Second, inhibitor, is the this a to mechanism least of you're where you

a by So of it of finish but hanging lot you based I'll segueing circulation, the program. prolonged mechanism. the action you have on pharmacodynamic have related a don't do around Maybe covalent just duration in into a

in genes, pre-clinically of in include program CDKXX yet of like transcription Origin The a CDKXX bucket a second much in clinic we would it are involved inhibitor. XX CDK XX. CDKX, ongoing felt XX, the a with regulating but CDKs that and not have for that but they are various also is involved regulation, and nothing subsets and

response very I DNA genes, RADXX, X damage of but on which that of think much very like interesting based involved BRCA lot a is the tool. analytical is of regulating biology, CDKXX part it's things in transcription

to advancing things in a we'll go also development take into one well, CDKXX hopefully, which if the potential And be inhibitor. there's directions preclinical So in inhibitor. CDKXX

Peter Lawson

Thank it really And you. you you. inhibitor, a do combination? Got have or activity the could think CDKX single-agent requires

Peter Lamb

robust tell is models. seen single-agent preclinically, number in different that certainly can we've what it's I we've you, activity Well, of a seen

point we're time. with commented dose Vicki XLXXX, As in in at this the early escalation fairly

combination, a the but in a to as single tell data. of clinical both and respect So agent with development certainly, time rationale there's will

Peter Lawson

you. Thank you. Got

significant? question a could area final for where around an OS Just HCC is that XXX is And The first-line move? filing dependent being HCC. XXX, upon

Vicki Goodman

Yes.

be in where potential to other be for deciding And before evolving And treatment we for and whether do other the types quarter. of appropriate it's see thinking consideration be question, demonstrated for seeing So XXX about XXX, XXX in answer that plans this do final activity analysis hepatocellular of has we'll or in to cabozantinib OS later well. your file. yes, not we and landscape as the totality tumor we'll tumor the development we'll in the evaluating carcinoma data as

Peter Lawson

Perfect. much. Thanks so

Vicki Goodman

Peter. you, Thank

Operator

Thank you.

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

open. line is Your

Kennen MacKay

for the Thanks question. taking

later for of or impact treatment be at that, choice you For of intermediate risk, is drivers this the an Vicki, SBLI X you ICC another? could quickly been frontline happen that around have favorable this successful? X If data that can XER NCCN And the that CheckMate year? into could what physician is risk maybe in weekend GU over here? ASCO something X do for half, Category and P.J., turned echoing Thanks. for regimen think for Mike how on if preference poor first that think anything the sNDA, X physician And and there in it's longitudinal COSMIC-XXX recommendations data is then with the maybe

Mike Morrissey

Vicki, do one? take to you that want

Vicki Goodman

XXX? to. Yes, sure. Happy Right.

would half data-dependent. them expecting we motivated this to the see closely COSMIC-XXX a we with Squibb, this get primary soon be survival on to We're Bristol-Myers and very study, work and progression-free endpoint obviously partner filing are as in So very with year. of first working the as possible, and readout that

P.J. Haley

I efficacy, And in really groups seeing uptake, really clinical utilization, regards data With balance also results of broad, life first it's and Great. think Kennan. seeing good really favorable, and I've of settings. question, seeing -- [indiscernible] that I we're cuts and And is think with kind that that's XER. resonating of kind patients. in across of our intermediate in the academic prescribers driven by And to of your broad in the well P.J. quality the disease. it's and mentioned, or see that's We're they're terms risk tolerability preference and really community physician its of as whether we their what line,

only I think this. a -- year into So that we're

to the to they're of longer we're with in the say to experience further the that I'll of it gives in weekend certainly regards perspective. continue us kind with opportunity terms think grow I What is, So pleased getting follow-up. data this

it nothing durability data certainly, really the XX%, to perception I overall. the The shows And about to rate complete response the is plus. profile. of a of -- set tolerability importantly, the increasing think the change

follow-up power little a I just our more it. more gives behind a So little more story think,

with we're year. very towards So the pleased business very optimistic mentioned, as And I that. the we're of this momentum

Susan Hubbard

Thanks, Kennen.

Operator

you. Thank

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

Your line is open.

Jeff Hung

Most been asked. my of the taking have question. for Thanks questions

for strategy want there you you to since technologies, partnerships more be more remain with on forward. bring Is technologies going and additional in your new that opportunistic on? capabilities about platforms you partnerships forward one to mentioned additional technologies? focused of collaborations Can maybe So to terms that it clinical more you or certain and Thanks. expect talk are

Mike Morrissey

Peter?

Peter Lamb

I that both for that as on take platforms to of we both now, discovery we've preclinical the broadly, -- to complementary to continue on targets earlier, target classes. side, kind mean, be will Yes. kind of various ability think we the or to been certainly alluded we look side, biotherapeutic molecule broaden may and I on have or to what our access and small tackle

first of make happy and we're sense our do us for partners. kind they those So as to

that said clinical has well, as a in campaign. continue asset times before it have Of ones as preclinical that particularly on we either as an that front, late are be individual number terms development of there But behind an look assets clinical. mount course, able we've to assets we to conviction think early effective of well, to being at I

And so mantra that right taking the that. still we're price right kind molecule, it's time, to basically, right of

Jeff Hung

Thank you.

Susan Hubbard

Jeff. you, Thank

Operator

you. Thank

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

Your is open. line

Chris Shibutani

you the Thank questions. for Great.

over XX%. questions; in first-line going for have You it's line use any I think competitive described Is be has less? XX%, Is coming is would of use nivo you be regimens that likely in or outlook setting first the the the what to the you where certainly be the greater the about to years? been that could said combination share previously to Two stable? the RCC a being IO that dynamic. of What doublet marketplace say have The ipi. primacy very it shifted. with as taken and

P.J. Haley

regards is what we've data Yes. and in it's It competitive the P.J. seen with at a that's Chris, market, BA. to certainly nivo

As to that. predicting given, wouldn't far you as it, endeavor as of out, the the market, I point do competitive nature

think I think treatment to lot about really in TKI, of just potential of I is mainstay that it gives which XX XXX regimen. potential IO place a add of now for As a in which obviously the us doublet, treatment solid study, a a terms has though opportunity. years To a RCC positive

I yes, perspective, think more think, I So, forward. that's from a dynamic things going

Chris Shibutani

the observing FDA. working Got this perhaps the over decisions XXX some about at thinking question your it. strategy lines development broadly players industry, a in from the of advancing of weeks, all XXX? well And acceleration as decide perhaps. the but other know it leading there's this into need. I as question thinking follows We've to more been oncology, Bristol for question this in couple at the talked you steps seeing then how by the for be Vicki lot I'm Merck, about context a question for come that time realms factored next I unmet know FDA, CRC, in factoring Vicki, asking prioritize for as well. the of where approval last of you you've that as of interesting across into of with you're of as some how we're in. And the Is experience

Vicki Goodman

Yes.

we're looking we're development as at plans, thinking multiple obviously about So, factors.

course, need is transform care to impact of time, how we watching this, about are a we unmet and opportunity landscape cancer. clinical development And about big plans. think the regulatory thinking same have thinking patients we may our areas where at believe we're the the that with I the of focus as

develop So, demonstrate to course, account cancer. of as developing taking we So, where we're therapies our realizing, really, intend have may we medicines FDA that closely around areas on climate the our plans, course, of that into we But look we're benefit for we're with believe to the at patients world. that experimental watching focused the right? our trends, regulatory globally,

Chris Shibutani

line. terms in cabo housekeeping X just revenue lastly, then of the And it. Got

the you also were you had clinical Thanks. anything within one-off that give for us XXXX? Can in million or to or XXX that sales. thinking past trial and there trial where trial can $X fails, events? a quarters what clinical Just did into for a that the back the over in clinical particular hit Is about make things you unique that summer, your miss sense sales visibility breakout maybe

Chris Senner

Chris, Yes, Chris. it's

don't I'd obviously running the us. place those It's order with to have So purchase say to up the that we very visibility. are good trial

find few will out So, generally, those a months timings in few weeks, advance.

our don't good throughout have it's visibility so the in guidance year, And we included number. but not

Chris Shibutani

Got squeeze Mike, more lastly, if one could And congratulations. in. it. I

You the it see Board of had of composition a care you of at in tech about sector. someone to the thinking was new add Tell year. was to outside us the were how end I intrigued about the overall from health Board. the

be that time, who've folks And should around some for Lance level? we here. thinking an interpreting been had and Stelios you You've made at addition very whatnot. and the How Board long a

Mike Morrissey

sure. For

not and a part part of digital how forward. us have about is we've Wright of to just She and And pleased expansion IT a growth is go, high from a at Jackie So, sure corporate digital bicostly, a really into I'm our to globally broad only going we're Board want amazing to the we resource it our Microsoft. very also but as perspective. talked previously, level technology to join component key from

to efficient aspects well. all look us. her digitally really our as also just engaging have helping her a is her become going of with then lot how So tremendous to both to more on digitize of for healthcare engaged business view and but resource forward her learn a to from much We're

Chris Shibutani

Great. questions. Thank the all you for

Vicki Goodman

Sure. Thank you, Chris.

Operator

Our Stephen question the comes Stifel. from Willey of next Instructions] [Operator you. line Thank with

is line open. Your

Stephen Willey

Yes. for squeezing Thanks in. me

when quick then notion Bristol, we question look the XXX, surrogate and just the development in was obviously follow-up. a at data I Just I XXX strategy on But data RCC know think cabo. have nivo/cabo I both GU But a with with you and to bladder. plus this ipi/nivo/cabo I that STELLAR-XXX actually, predicated I study had with guess have respect the on so

a IL-X on Phase strategy better into going to did with how data to have the side data bit like I expansion trying III cohort We but atezocabo opposed you is, in understand as a the deeper GU no Obviously, going STELLAR. prostate. just guess, yet,

Mike Morrissey

I a you commentary color that some us Vicki, maybe want afterwards. shot and can to at take provide

Vicki Goodman

to, sure. Yes, Happy right.

at So multiple we're looking for potential combinations XLXXX.

those out see which of data launched COSMIC-XXX colorectal to the the earlier, cabozantinib, a I that road. forward move also evaluating trial, of you quickly, the think agents. of important in the And as important program are limited is the may at down I will XXX said may, number right I/O additional that study in to cancer of to being advance one order coming again, look we of settings, Phase the and believe and there I/O from be inhibitors XXX recently combos in IIIs we initiated potential checkpoint for combination enrollment, which combination STELLAR_XXX, But with them.

Mike Morrissey

that. in is business do patients. for focused bar care Everything Yes, standard of maybe we in I can the of of the terms that we're just raising on add, Steve,

but think going And data, program. level. first next less example new a that more narrow across are to develop as as certainly, do we And XXX two good control broad it's first arm. against So with the XXX, going I/O, indications the I/O the indications, of generating company, like opportunity across I trial about things that, have about to we that

that wave I signal as trial while STELLAR-XXX, the launching efforts stellar program. first pivotal – the signal validating type look would the STELLAR-XXX we're of wave So at searching,

with if I/O people have ongoing partners, with and to molecules We of discussions combination other combination combine we they other you with XXX. a types that different other of want variety other and will, owners,

a multidimensional is So really way. the advancing program in

here is beginning. seeing you're the think I what just

Stephen Willey

one Okay. That’s follow-up quick helpful. STELLAR. on And then just

investigator-sponsored know before was study I've used ease in I modified know liver in seen Camilla criteria. but an used a that seen haven't it I trial. guess it I RECIST So And But before I cancer, colorectal.

liver figure And know mets Did that just all wondering response you or a instance. patients to if guys Thanks. was why modified in trying so this I'm or have something? just assist out. used

Mike Morrissey

Vicki, can say you Yeah. there? you Steve. I have do don't anything know,

Vicki Goodman

of been is don't specifically, COSMIC-XXX, in terms say data expect our Not also to the really. having response and what from the what same but direction would that data know two own I including trending sets, the has historic in relative I historically better set internal rate controls. with single OS than would overall encouraging were arm, we both regorafenib. And although for medians PFS they're seen both

Stephen Willey

Thanks for question. taking Okay. the

Vicki Goodman

Yeah. Thanks Steve.

Operator

time, are Thank questions in the you. At no queue. there this further

host, would like Ms. over the to I Susan today's back to turn So Hubbard. call Hubbard? now

Susan Hubbard

your and We Great. follow-up questions Yeah, great. you, thank may have. you us Thank joining additional all for Towanda, calls certainly with you today. any welcome

Operator

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

disconnect. now may You

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