Exelixis (EXEL) 5 May 202020 Q1 Earnings call transcript

Company Profile

Participants

Susan Hubbard	Executive Vice President, Public Affairs and IR
Michael Morrissey	President and CEO
Patrick Haley	Executive Vice President, Commercial
Christopher Senner	Chief Financial Officer
Gisela Schwab	President, Product Development, Medical Affairs and CMO
Peter Lamb	Chief Scientific Officer
Asthika Goonewardene	SunTrust
Yaron Werber	Cowen
Andy Hsieh	William Blair
Peter Lawson	Barclays
Michael Schmidt	Guggenheim
Jason Gerberry	Bank of America
Silvan Tuerkcan	Oppenheimer
Kennen MacKay	RBC Capital Markets
Stephen Willey	Stifel
George Farmer	BMO Capital Markets
Paul Choi	Goldman Sachs
Jeff Hung	Morgan Stanley

Call transcript

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Exelixis' First Quarter 2020 Financial Results Conference Call. [Operator Instructions]

As a reminder, this conference is being recorded. I would now like to hand the conference over to your host, Ms. Susan Hubbard, EVP of Public Affairs and Investor Relations. proceed. Please

Susan Hubbard

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

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

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

During impact events and pandemic presentation, the commercial, strategic well future This performance development, the of developments discovery, statements future Exelixis' includes the COVID-XX product matters we making company. forward-looking operations. and regarding course as regulatory, will about the of regarding possible be the financial, of statements on as this business

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

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

Michael Morrissey

you, the All for to us Thank and Susan, thanks everyone joining on right. today. call

across quarter components Exelixis all business. our of had first a strong

a navigate power continues ensuring either cabozantinib a to team entire trials. maximize do challenges patients our for in access singular clinical working the remotely as cancer pandemic Our to commercial channels of cohesive with everything focus to of that COVID-XX unit we the or through

recognize part that We great need to the short patient questions and lengths access keep update. gone remarks prepared take your cancer to We'll to of ensure patients in today's medicines as treatments and to our challenging address the main we've times. our as these directed

press our an financial corporate that extensive our issued of highlights. ago an release see hour for was Please XXXX results first list quarter and

level. performance update brief I Before business organizational of to on want in COVID-XX we responded at our to review an how the the provide has Exelixis quarter, a

so is safety virtual the priority order the of Our pivoted workforce, top to Exelixis points of move and implemented health California shelter-in-place our the home we our work from force and prescribers. to ahead sales with touch quickly policy

community team our to corporate the facility. level pandemic, during the COVID-XX the donation local cancer and patients by has engaged in personal against time, the level At the through protective of plus to the same fight at supporting of care on Exelixis Exelixis XXX organizations matched donating equipment charitable members which have the a

and XXXX optimistic relatively that timeframe impact the quickly us for our and evolve the to date. continues a and focused of on and to We'd has The We had achievement COVID-XX a period brings case can remain be modest XXXX execution business Exelixis. best I'm certainly think to Exelixis. - out bring at times tough that's the like people say that proud to in pandemic

enrolling to have by on level year-end While remain the for the indications cabozantinib of uncertainty, we gives course which data the six new on label-enabling pandemic challenges to of could day-to-day to lead rise achieved a year, readouts our four and potential is top track line imposing trials XXXX. for and in over operations XX cabo

We combination and from three for Obviously, the to at update XLXXX internal up ICI inhibitor or progress collaborative cohorts to we immune new this and INDs also we'll or file is checkpoint advance as expect effort. you, stage year. continue everything to fluid compounds into throughout

RCC tolerability combination TKI read cabo-nivo through The and combination CheckMate-XER recent for backbone provides strategies as compelling can potential pivotal a new and in for combinations in of the and other important ICI success driving with indications. highlights trials play and the ICI in cabozantinib role both encouraging ongoing planned first-line efficacy

we we the today, Paragraph book-listed letter. challenging cabozantinib litigation Finally, patents matter and use have know as method patents, patent, of ongoing already the received in MSN IV notice has that IV Certifications a composition Earlier an two Paragraph you additional and asserted against of their original MSN. not filed

surprised not are of We business. such standard by in as course this pharmaceutical challenges the ordinary development,

vigorously and strong I believe very protects growing respond to to property that be a prepared drug estates an intellectual innovative importance. cabozantinib, well what are defend of We medical

who So update to call Gisela? will the Gisela, with on I'll development CheckMate-XER an that, activities. and provide over turn other XXXX

Gisela Schwab

Thank Mike. you,

for groups. cabozantinib to RCC brief including update study CheckMate-XER on sales sunitinib start the our pivotal and with important Phase provide nivolumab a development I'll untreated plus in quarter. pleased This and a compares risk exciting with trial in very patients the very by previously Phase X recent IMDC all regulatory I'm progress BMS. announcement X with

completed projected in has announced XXXX now and The XXXX. as as April XX, top-line achieved on earlier results study enrollment

extremely are CheckMate-XER We three with the results endpoint. that that showed pleased met all efficacy

ratio of death independent by sunitinib progression-free the in hazard within less and X.XX nivolumab of a reduce or was endpoint combination of compared primary cabozantinib The p-value disease X.XXXX. risk assist with with significantly progression radiology than committee survival

rate responses and The with response also objective significantly ratio The and secondary X.XX equal compared objective of X.XXX p-value and and deep with sunitinib survival improved a of durable a with were endpoints overall with cabozantinib nivolumab overall combination rate. to a the survival response hazard observed.

safety a low adverse preliminary CheckMate-XER favorable frequency profile The the combined was XX the a safety of with follow-up nivolumab treatment milligram cabozantinib XX.X data of of median due The events. discontinuations to with dose with combination showed a time analysis of months.

who and as of We would the well like personnel their thank the midst conduct pandemic. for site study in for of the the patients ultimately delivering investigators and this for participated in during important the the trial to COVID-XX perseverance patients as this results

and like also work the as our our with trial near We'd toward forward to Bristol future. we to regulatory collaboration who filings the at BMS, congratulate Squibb, Myers collaborators sponsored continued look in

conference. will of We also to that CheckMate-XER be an presentation for look the results at detailed submitted upcoming forward medical

for for concept that clinical enhance may support add body striking inhibitors cabozantinib data to and checkpoint and with of growing immune the preclinical activity cabozantinib for immune further These the combining rationale inhibitors. of results scientific clinical checkpoint provide the

in combination tolerable at cabozantinib XXX the as GU the hepatocellular in Phase atezolizumab cancer our starting seen year. dose cabozantinib CheckMate-XER presented it reinforces CheckMate similar safety nivolumab in further also expands GI Xb data ASCO X from cancer XX and this of Moreover, trial the the on observations milligrams and Phase profile presented in and trial ASCO analysis preliminary of with safety in and cohort at Xb prostate COSMIC-XXX

broader term combining for our rationale ongoing The across development near inhibitors programs for and planned directly cabozantinib and is relevant types. cabozantinib different scientific for checkpoint tumor

and X tumor evaluating near-term pivotal combination the of Phase trial, trial and and ipilimumab versus nivolumab large sorafenib and RCC types ongoing X as first-line or studies the multi-cohort the trial COSMIC-XXX well Xb This Phase program our combination cohorts Phase comparing ongoing spends different our as COSMIC-XXX of planned the cabozantinib including with cabozantinib in study atezolizumab ipilimumab in atezolizumab first-line XX XX and in HCC in in atezolizumab many settings. versus across a cabozantinib

lung CRPC our our and wells collaboration in renal non-small X XX-XX cell agreement. near-term As cancer, to under cell well Phase as clinical studies plan cancer

of late-stage This broad program patients restrictions pandemic even the for development progress in good making challenges sites the presents very and travel is COVID-XX and quarantine. face that cabozantinib given the

additional And words pre-treated COSMIC-XXX lung of non-small nivolumab agent second comparing from We and cancer few results forward three X and presenting cell cabozantinib future atezolizumab NCI's Conference. as to and from biomarker cancer well cancer X upcoming single our close, cancer Phase as nivolumab including in the endometrial and just randomized study program. in ASCO and to regarding presentations look prostate inhibitor from cohorts checkpoint bladder cabozantinib the evaluating study our with line a results cohort a

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

Christopher Senner

Gisela. Thanks

included $XXX.X the fourth million. our included For Compared of first the company of the $XXX.X Ipsen, typical total net weeks $XX and CABOMETYX range the revenues increased to approximately XXX approximately X.X of quarter on Genentech. company's Takeda reported inventory Total from XXXX, at for in million. revenues hand. collaboration also to weeks the XXXX, revenues within increased cabozantinib held customer partners, hand product by inventory of quarter revenues and franchise remains collaboration X.X and revenues inventory commercial of the from Total units quarter on million weeks weeks

Our million primarily clinical was invest we the in clinical expense increased driver continue as to first expenses the of trial the in which primary expenses, operating to expenses, XXXX the XXXX. R&D maximizing to were and million $XXX.X by and approximately total for cabozantinib. compared total potential $XXX full million of was commercial $X quarter related quarter in increases operating fourth the of of increase in

a share net and fully also million and quarter quarter or rate diluted first $XX.X $XX.X compared for was was net tax $X.XX Provision per for $X.XX on of basis $XX.X $XX.X million fourth on GAAP taxes of XX% the share XXXX. diluted Company of a XX.X% income for quarter the of Company per income reported for the or fully to million income quarter XXXX XXXX. million non-GAAP first the our for effective basis. reported

expense, approximately XXXX Non-GAAP quarter over million stock-based effect. increased ended related March million Cash net of to approximately $X.X the $XX billion. net of the XX, and of investments $XX.X by impact compensation tax income during excludes income the

continue range are to X% revenues. is are and to therefore, and expect guidance earlier of pandemic product Now we of X% fluid and and of to net be while of be recognize we million expected expected we revenues our maintaining provided to financial in very this product believe is the cost financial be goods guidance, turning a to sold business are of revenues situation, $XXX the $XXX million of strength we impact Total COVID-XX $XXX net the $XXX year. in our million, between range the the in million,

Research and compensation million. in $XX non-cash related stock-based be and million of are of $XXX the development expenses and $XXX expenses million includes to to range approximately expected

Selling, to non-cash related general, are the and $XX of million expenses and million be in million. administrative expenses to $XXX of approximately include expected $XXX compensation stock-based range

expect rate Our between to effective be for XX%. tax guidance in and the XXXX XX%

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

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

Patrick Haley

Chris. you, Thank

I'm did combinations. commercial we immune of significant the pleased to checkpoint as market, in to With notable first-line the to first not review inhibitor first number XXXX CABOMETYX which which we increasingly RCC, three in prescribed the CABOMETYX to business, in stable for see one be quarter the the is performance competitive QX includes quarter, context a TKI regards in an CABOMETYX of XXXX. now the continues demand XXXX. or ICI COVID-XX relative was QX impact of

providers been the has US. continues the has who pandemic on focused healthcare in compliantly the team and since hold treat patients to CABOMETYX taken supporting Our be

the drug continuing Program. We of as availability are customers Access to supply Services Exelixis our by them or as EASE proactively well to the on supporting educate communicating

calls We digital virtual are through phone programs, and this lunches, speaker doing tactics.

to this the focus CABOMETYX in appropriate have continues across and In patients access in and settings, community to grow prescriber used base therapy CABOMETYX groups, times. appreciate QX, their customers and of broadly therapy. of on these clinical challenging risk continued CABOMETYX ensuring lines RCC academic Our be to

the RCC majority patient in approximately remained patient new share first-line to and or of of As this market. XXXX and share the half with first-line capture of CABOMETYX second have into the mentioned, first-line ICI the the new steady continued XX% we previously QX market market continue stabilized combos

outcome recent opportunity us grow these the the with increase We of results pending study, regulatory in the the as are by therapy duration provide approval share market will CheckMate-XER line. of excited first and CABOMETYX to

opportunity for the market knowledge this our in in the we look this to has forward time, appropriate to team and experience setting. CABOMETYX would more to data RCC in patients deep opportunity educate been now from so have the years, physicians on we that the four over first-line at benefit and have As therapy

more to We ICI share are combination driven increased second the second QX, particularly that XX%. in choice made has market patient patients, setting be progressing benefit in with pleased progress line where is into of the new population. setting, CABOMETYX was the due that the pre-treated where CABOMETYX This by only the in line of a the the continues with second-line majority fact per label strong treatment to TKI OS primarily these for the to the patients

to We are see the and market strength trend marketplace play continue. that will this anticipate in out pleased in the the second-line

briefly will which what with new to likely care Subsequently, in cancer be The patients US and we market receive remains an HCC the ICI Turning moving a front bevacizumab the combination the HCC evolve saw to in We CABOMETYX and important to landscape liver first-line stable. serve could standard first-line the line, RCC therapy market. for fashion to combination expand of the treatment-naive atezolizumab soon. of HCC. business will approval in similar anticipate

ICI in the line use over decreases setting, line time. We in utilization second turn second anticipate this the monotherapy TKI monotherapy increase will

combination we the add will next for in immune year. inhibitor in the this data provide cabo to further potential to the represents readout and with growth HCC opportunity Additionally, X CheckMate look presented to with checkpoint COSMIC an ICI of another XXX data cabozantinib combination earlier Phase forward franchise. XXX

TKI immune combination many prostate HCC, believe forward from program benefit patients, prescribed and and expands building future in development could progresses. more and strongly who and inhibitors this potential as there in CABOMETYX lung the on number other CABOMETYX. cabozantinib look that momentum RCC, our We as we indications remains to RCC are as such checkpoint with evaluating and eligible one

opportunity of to as X trials Phase continue combination first the the to markets, the bring look and cabo out is these XER from we read to to data to exciting this forward franchise. build The combination we

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

back to call that, Mike. the With I will over turn

Michael Morrissey

P.J., right. All you. thank

in in said I XXXX. off to we're As intro, the strong a start

advance should recognize we additional clinic. to in into or data-rich risk we severity expect business, the towards potential we continue new cabo grow a of compounds and our unabated, as While the indications as pandemic the now, year,

to we cabo momentum present medicines. at Exelixis importantly, line We're ASCO continue as CheckMate-XER, the meeting. we indications to data upcoming Most and excited hope throughout diverse virtual portfolio our the our the additional build the build results to out year specifically from top to cancer for and new next-generation on path chart a of

for close by truly their Exelixis I'll everyone early efforts thanking March. herculean since in

also home efforts team has Our two been almost of working from behalf troubling patients challenges on facing for months their while now, times. uncertain is that the these and personal cancer juggling everyone continuing in

patients been conditions every resilience, cancer entire proud day under is I of The even commercialize and and or the count team's in discover, medicines never making we effective by trying team of generation have such for more commitment. inspired better next focus, as dedicated to therapies. develop, now the and our need more

your now in the the our on you updating open in interest to future. to continued for we're progress Exelixis Thank and questions. and forward happy look support We call you for

Operator

Instructions] from Asthika Goonewardene [Operator comes with the your SunTrust. first question line of And

Asthika Goonewardene

my Asthika iterations from very is these Congrats This the to I Thanks on on SunTrust. some Goonewardene and execute interesting continuing name for to find well. I taking want calls. question of say

X. cancer. and lung So in cohort more have the for about ASCO business results here, do prostate not I to to a for I'm from time going ahead, But the the ask you question of some with prostate had two. I biomarker cancer got Gisela - analyze you some

think the most get would kick on that but follow-ups want this You a we'll to like data what data know, And translational your quick set. in I I've I the to see view is had some asking interesting then analysis what of to is, after and ties not you Gisela, time couple I'm got that.

Gisela Schwab

a which alteration, seen study, looking the COSMIC-XXX program already biomarker of immune we and tumor looks for CRPC without various patterns, cells, pretty so the the a at the what provide we'd genetic components information data and to it's expression it's cohort, ASCO. broad and at the forward preempting on So says, the data here have program cells, certainly clinical broad that

Asthika Goonewardene

RCC, overall, around coming delivered But type, coming then, maybe late on if this next to HCC XXX that year. beyond lung exciting and tumor what's And non-small these. going hopefully CRPC out - of so be you've that's that's corner cell the the really

Gisela Schwab

So we HCC ongoing first-line XXX study have this a and and so yourself, have cabozantinib plus we is you that ongoing comparing and number line, of plans mentioned the to in versus speak sorafenib. and atezolizumab studies,

of study. adding evaluation on lot XXX nivo-ipi into COSMIC-XXX We of go RCC backbone and have the in in a indications cabozantinib study in certainly the the

We mentioned COSMIC-XXX second, is looking in line the our as this think differentiated single-agent placebo cabozantinib I thyroid versus you also in haven't evaluation cabozantinib - of study. one indication setting in cancer third

XXX For a of we a rate response the evaluate that the with and in trial, objective minimum trial. involved February months patients we've look forward of sufficient in to six follow-up

lots the So and on. certainly goes that's come as to years ongoing

Asthika Goonewardene

for of one it's can next saying, is year on more see any you're maybe in Michael sort in we'll that the when last it at XLXXX, have you a terms little clarity know that look - a I that in - - on in first any soon get time - And have we that? clarity this

Michael Morrissey

Why Why to want don't we don't address go that. we Lamb, Yes. - have question. for ahead. thanks the Peter you Peter

Peter Lamb

Yes. Sure.

right and more have as three half the we now. to present second a of programs, based INDs XLXXX on preclinical XXXX, guided actually to advanced intending pre-clinically opportunity what's this the to of in year definitely number for going data So of for up those file we're on kind on we've

second still getting those where information quite as haven't finalized meetings and what we get now, content number some forward programs the I we'll update or on exactly so that tuned as out a or what I those yet of of details to XXX stay will As said. in so down. be, the exactly half left, look and opportunity locked is

Operator

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

Yaron Werber

couple - the critical to actually long over the term. look that I way business have the of actually start I let's questions. kind think Maybe, is XXX a of we at

just possible you follow yet X, you of question going what to year. data. combination that a pivotal cabo. need monotherapy to one, I next the then as And Phase started questions, so, about think established the is you a then have a And have it to were about And maybe move couple to to start cohorts

Michael Morrissey

Gisela, you go ahead, why don't that... answer

Gisela Schwab

Mike. Sure. Thank you,

we cohort, expand see in will there, So the and quickly such on observations, and it regarding from we dose your patients the checkpoint months we escalation question, like evaluation agents be at but little where bit we've certain phase dependent. next inhibitor opportunities COSMIC-XXX relatively could still for in forward on in move to data potentially we study, expect a done are are that numbers the evaluation, combination enrolling and we that the XXX what are the larger occur like few indications with to preparing we of similar in all there if

Yaron Werber

then, and of expanded let's up both should OR I Gisela, maybe many in what's a And how cancer give for sense combination you XX recall us patients. cancer do ASCO was you the line, with response. right say bar how Okay. durability the in pivotal to in at on patients we COSMIC-XXX, see, there can in the second to data move to look lung of And

Gisela Schwab

me, already that numbers, patient you and and cohort won't pre-treated prior the evaluation in look at for the do so. see I our shortly that's as in into at look and this, want inhibitor and to the have aiming all to We'll certainly and cohort continue said we for cancer to for to we lung first we've begun Like first sufficient so forward that presentations ASCO we've said, follow excuse so been expand that see that get checkpoint patients, we'll at calls, Yes. what cohorts up ASCO. specific

single think speculate to your and not while point there this we on that And on in approaches bar, approaches at question data agent to ASCO on regarding time. forward or at combination there's the you numbers setting certainly in going data certainly presenting we're the the showing look I point, results out the and at

Yaron Werber

thinking look is response And combination the we but and at if docetaxel that you're rate that's right of Okay. of XXs ramu, in - kind bogey. the the

response of You're bogey. XX of or rate not thinking let's that say X to XX docetaxel single the agent

Gisela Schwab

Yes.

there leave there I are data As multiple there. couple you certainly out it and literature and points in right a mentioned I'll said, the so, and

Yaron Werber

maybe mentioned on from last just quick range, X.X Chris, to weeks exactly Okay. weeks question, a increased you missed the inventories the normal you remained inventories. to sure X.X heard within and Thank that the question, it we my make growth and it's just comments the you. I in

Christopher Senner

it's Yes. Yaron, Chris.

increase XXX by So about it the weeks on weeks - weeks QX, we so which units, from to was QX. X.X hand inventory increased did as which our X.X ended

Operator

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

Andy Hsieh

results. Thanks questions healthy. staying congratulate my is at for XER positive and well, and for hope competitive team safe taking everyone Want the I the Exelixis to

efficacy we your both and on So and in the confounded craft I that's thoughts a metric, communities perhaps to understand and comparison your curious investment totally clear to are patient maybe and a that's overall the about alluded about curious context head-to-head thoughts But survival. that, there. physician survival of progression-free comparison think trying

Michael Morrissey

Yes. maybe commentary some and can then Thanks Andy. P.J. start Gisela, why there color provide don't too. you

Gisela Schwab

Absolutely.

all, efficacy three we're of of met course study the really endpoints consistent first that strong showed and So results. pleased all and such

by strong certainly how is of but is measured I evaluated review, the showed course PFS, it therapies, radiology independent other because think endpoint very it it's results, so the of by Regarding primary endpoints. did of unconfounded but the subsequent it and nature

With to that, it hand on I'll P.J.

Patrick Haley

on to in the forward look seen line we've really results Based historically all, have first the the do, is it. in to etc. XER, the of It's all of we've important market is patient, by there excited depending out extremely of we're totality too. presenting data well terms efficacy on we results, top done the doing you're hope the I and Andy, Hi Yes. research, the

on think is as endpoints to strength I this pleased that's with the as the We importantly to able well. patients we're from time, is for the well we're are positive should themselves from and manage results. them we profile we've business, really long market XER the to on with duration share and a cabo therapy all get tolerability well. which be be therapy and important about and why the there be and they have them keep for ultimately as too, these have to then certainly that excited appropriately in the look that patients important and and the increase mentioned So for physicians It important the very as with, in first-line pleased hear setting and as

Andy Hsieh

insight. Thanks that for great. Okay, additional

the potential given at has of at and the the additional from X synergy that, I'm AACR, rationale AACR. so context trial, we're any things cohort investor pick transpired results providing is between we in just what considered So and to wondering for about saw detailed put you cabo preclinical nivo the thoughts

Gisela Schwab

Yes.

that themselves, saw interesting in in is, neither objective is rates think responses certainly what nor X a atezolizumab response there of per we setting. in XX% our us was by strong this any the response for rate response and resulted trial to published high fact cabozantinib was can the hardly the are design - a observed I cohort data situation where rate

more permissive in immune to certainly checkpoint activity. signals in think So April cabozantinib on environment in activity and a cooperative basis to and the against that biological inhibitor the a I results the front us

didn't speak that to can negative think alone that, show think ambassador I combination. the was data improvement So study we any I over enzalutamide the a and and

each this think rationale, that need I to the large study But And off they're and so and answer setting guess biological the definitive that and a in we particular that's at combination. look for I independently. combination

Andy Hsieh

And XXX observation, a interesting study, two an think Merck sponsored sponsored I trial. a just look at Pfizer Renal that's trial, quick the JAVELIN ones, it's if KEYNOTE-XXX you

in not - So in data both for the trials the included wider label. was

the that given wondering is So of terms kind regulatory fuel labeling I'm just the the this make April driving the a enforceable. that process on all fact just during patent also XX-K, the in the the starting, us goes is and process the be want to sure Bristol for side, can of of trial, thanks educate additional in information the that process on to if you bench kind XXXX still if way time

Michael Morrissey

the why Gisela, first take to come last question. question ahead don't you go Okay. then and regulatory and I'll back the

Gisela Schwab

Sure.

for lead less trialing of that, anticipate would the would we the also who a sponsor BMS, course, we it's so regarding collaboratively and inclusion label, decision course anticipate the the we a work be cabozantinib data to compound CheckMate-XER, label So in is specific of of BMO expeditiously to or the company ultimately but the a that past, by label. filing of amend towards stated was a regulatory in working for study the more the parallel And are to each to with of of as decision we really. the sponsor

Andy Hsieh

Thank you. Got it.

Michael Morrissey

all question, And last enforceable. are in it's book Andy, the the Mike. in your orange obviously patents

Operator

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

Peter Lawson

if use are the you've and of On after got on then seen - by data, that. follow-up that, off-label a the but about top XER hearing after you uptick top congratulations, data, I've seeing an line physicians any the after

Patrick Haley

Yes. Hi Peter, it's P.J.

in QX data that, so remarks, early think of with current terms, First that and off-label and in reaching now business strength expect our patient as very very my obviously market XER. of terms we well don't say, any and this XX%, the what any RCC preparing having I stable certainly the to then prepared in share in second we're from growth in what being momentum by - share been would I excitement in of the I line mentioned the we new in generally really is new at for foremost, point, I mean pleased will it's business first-line think and pleased promote presented, terms the I not very data, as in monotherapy pleased patient with general perspective

Peter Lawson

you you. breaking way Thank think you benefit, any and amid social kind follow cabo and that around COVID, of do distance you've seen guess use of that I a that then seeing does any increased are stay. And out

Patrick Haley

Peter. Thanks Yes. for the Yes, question.

been any think generally, that is perspective, communication think pleased virtual seen able support use market I'm speaker just we're appropriately treat end doing the at haven't doing and that on second-line meetings, a telephone to patients the with our the from really shutdown seeing who really business increase can the over to of occurred I compliantly, were in doing We tactics everything and meetings, they're that which we're the team strength in QX. digital our in-person to lot is in programs a our they more is share. of certainly CABOMETYX either like convert doing place online at of lot related incremental great, I those of said, the to I to customers

Peter Lawson

Great. taking you the much. Thanks questions. Thank so for

Operator

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

Michael Schmidt

and that potential how well over does as potentially kind that front-line to share if Thanks for of to KEYTRUDA by Opdivo congrats the or Maybe just and market on from, now the from us questions data taking which any cabo, do overcoming my pending setting CheckMate in P.J., what a me. of approval in RCC over physicians have follow-up think of quarter for the combination from light label. and about either move you you

Patrick Haley

Yes. Hi, for Thanks the question. Michael.

each the terms end market to pembro-axi, I range, in year you really having think stabilized I and is we've last of the the that's the nivo-ipi patient somewhere approximately what in in going have of the mentioned approximately that new XX% half of So that. first-line, what market share previously of the and combinations could prepared ICI and back think altogether their remarks said share, around is

excited data the will really and the look important. we're very So I certainly we XER think, launch, forward be at

that forward presenting data good we're to that. have So and pleased we look

of team that frankly We've other the place our years RCC RCC. is in and of with I has think The thing in in this about of a now market in time in stable a just knowledge over relationships lot lot depth been X a experience have marketplace. in team approved for now in

gave really, as really overall think you results. the previously that's said a terms two at optimism first RCC, trial as then talking of thing. to show I Opdivo benefit only drugs, and in the that's So which - monotherapy about look here, And certainly we're us in CABOMETYX, survival we great the

forward So we're that build and that as with really we the launch. move excited on to for work

Michael Schmidt

an that non-small Great. know one, there and Phase then and Roche to X some have trial maybe if cost go fully-fledged go this certainly still if done a committed trial in consider may have approval Thanks. if for now time cancer and or And to - into is just you was is wondering like opportunity to prostate I cancer just Phase a at I to X pathway lung on indication you cell point. an accelerated randomized this this is

Gisela Schwab

This is Gisela.

prostate in think that cancer, I to X these to and said, have moving know, enrolled the be patients the forward cancer data studies - in forward lung you see driven three and and program, look on at obviously class cohort we towards XX to want months. few towards RCC collaborators expanded next studies also we are in total Phase the as and RCC be such the at cancer, the would study starting we also And those and COSMIC-XXX ASCO. considerations as to our a entirely of any data the

Michael Schmidt

regards about on the before just updating the - X cancer, arm conference that road study. with And more the cohort want the How one potential down prostate maybe medical should we cohort should filing prostate. at a Gisela then data in potentially of to think that

Gisela Schwab

Sure.

once see data now, presenting follow bit sufficient to for it's the a hard too now. also tell not if a little to would expanded steps any early want to before the warranted remains that comes be consistency, seen, say bit really whether anticipate, I but think right regulatory up mature it's data the coincides the it by right cohorts, certainly that and to little or we'll or

Operator

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

Jason Gerberry

this, A they in couple cancer, are patients of concern. hearing are so is from things because physicians in renal get Yervoy that under Opdivo we're a a pressure risk who toxicities higher immune demographic, for first is the related of one me might age too, that the Yervoy use coming

beneficiaries that IO the how CheckMate-XER TKI because the potential mono I'm obvious an a So into you TKI rolled wondering the about as combination. out opportunities or will see market, be opportunities, eventually

leave to I'll get guess, question. your that thoughts I there on - that guys first, So just

Patrick Haley

P.J. it's Yes. Hi Jason,

regards I of data, stable. or COVID is and previously, the mentioned of to with frontline one seen strong way is pleased in that our to market haven't the seen, think a sort far I commercial data monotherapy TKI share we as market impact in kind data we've market terms We're that thus of other. big cabo the the business

so patients, of strength months kinetics to COVID second in in of the wouldn't time that with and to to checkpoint be growing to line line and continue, really anticipate capturing be to important customers. majority immune And want progressing I that, we're inhibitor that over and pleased off those just to think as is do going regards really with our the really therapies really as the would in far the more regards but speculating data what's are opportunity the second the is vast to particular, to bring have I out to able launch, many we're in

Jason Gerberry

other the we IO have what patients So it of renal. an for patient question you don't see in resistance. for at was select guys like to on from in been acquired much on to like much Opdivo have impact the at requiring who aren't presumably - say but about some you months, enrollment it to don't realized space, to from My I strategy, looks IO see they're four least companies sounds combo lung, other Yervoy patients going least just you

your the just doing Thanks. and materially whether reduce to in strategy this get curious a thoughts does into so, setting you addressable that's So that prudent on post-IO market enrichment size. going think

Michael Morrissey

want Gisela, you take that to one.

Gisela Schwab

you're acquired question or right a a guess than the resistance to I to inhibitor is around bit better one acquired course a is checkpoint that of resistant there longer might that of resistance proceed who those and who suggests debate Yes, patients, had progress minimum and of might months have some in treatment population prior therapy. little the of that versus asking population be in priori four Sure. a prognostic allowing inhibitor checkpoint value

sure learning would not durations if will prior that strategy So course work towards, the of field patient we're population, you treatment go I'm you this enrichment a I think inhibitors. and longer require on still day-by-day checkpoint if about

Jason Gerberry

could efficacy starting a just either after not how seeing the IO following just cabo in XX and I your just and I follow-up. optimistic in CheckMate-XER, to better here, one with or if of go development how you're your from CheckMate-XER move the but an are learning the dose did. squeeze milligram terms cabo back forth safety And ability compositions dose modify. needle And to Are more about triplet to that perspective at you Thanks.

Gisela Schwab

Yes.

of more have been think strategy we're because further very the Phase perhaps certainly results drug and reinforces NCI with the done that and what to there if certainly excited the studies triplet has been most early and been about the I anything a achieve opportunity at Xb CheckMate-XER encouraging. in the seen even have

that Regarding gotten are a with the COSMIC-XXX bodes as the TKIs well, so to checkpoint there dose, then in the a accustomed of physicians there study the for and modifying been now, required, is learning time patients which and alongside as inhibitor going tolerability, well has holding think over if these treating lot certainly - certainly the available versed I occurred inhibitors combinations has steroids in well has checkpoint well. with

Michael Morrissey

cabo-nivo the context think essentially data framing ipi we and then got just nivo both as Yes. standalone well to given as Jason, one about protocol it's thing Remember, of in for in the I well. the how four XXX, how would also doublet as consecutive in is XXX. cycles the CheckMate-XXX terms versus and add we're of

XER read-throughs and dynamic So that - we potential too this clausey that in of there so. phase, his in like the maintenance kind data based upon

only win dosing, cabo-nivo based triplet ways terms having long available, in phase potentially many but also part maintenance in a encouraging which of XER powerful of more there's think of is terms then not a early So to there upon we the that in a potentially different data.

Operator

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

Silvan Tuerkcan

the key question view OS launched benefit what us here for cabo-nivo preferred to tell little and timing how renal monotherapy TKI choice - there and your second about forward you frontline in My first once the will more is line would is path being line continue efforts a And here. of you the post evolve carcinoma secondly, use is is failure. could basically be it second cell cabo cabo is adjuvant therapy bit and

Patrick Haley

the been to I'll line for second it in basically, dynamic the and But talk Yes. Hi the perhaps Gisela comment Silvan, is about P.J. we've think growth patient about years thanks dynamic second on over and with to think play adjuvant. patient a the then the timing what that's I year. sort to new of line pass we're question. of those of about talking while be XX% kinetics, now a seeing in and pem-axi if in out share terms terms nivo taken really would with of, approval you This of

for of them combo flow on a to continue second on therapy to already line and going years are patients, are those ICI right to therapy So many come.

share to With dynamics grow the get grow question and for really the an you is think duration then asked but regards same first-line I to second-line market pending continue opportunity approved patient to XER, we'll could and the in the market timelines, the some of setting time. and have obviously at regulatory because there, astute time

first-line cabo growing really with of now forward So many in years our the a which be monotherapy and and the sense, for of in second reinforces RCC could in a come. both RCC, data and choice, the in certainly in being we're line to combination moving possibility all where TKI the a and position studies respectively,

Michael Morrissey

P.J. of to that data in the for data, to the the be to journey certainly talked we'd body where who line vision, it from to able able second really We've from has based line have third be renal and with benefit cancer the possibility XER and upon of cabo patient to we about at line to we Mike. framed like the their in first makes vision way a head this data on. I the us totality think see some meet every is that the and point powerful line second This have

the work that of yes, as to a towards but working have forward. do, certainly we we're So go lot - so we direction that's

Silvan Tuerkcan

for therapy would there And if you plans on be. and adjuvant what have timing the the just then - any

Michael Morrissey

want that you please. Gisela, to address

Gisela Schwab

and ongoing and we cabozantinib going space, in play we RCC, a it new adjuvant at opportunity approaches interested and certainly some is space that XXX the be looking as to as the are forward for in in but time, Sure. of Yes. current at have we're so may At this in course, trial have point of we are some an there long-term eventually don't proposition context well. adjuvant

say. So stay would I tuned

Operator

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

Kennen MacKay

and monotherapy. what have maybe something potentially if is immune this ASCO life since this, or around really where benefit as tossed GU lung synergistic, responses your of with prostate about any back follow-ups as was atezolizumab speak on a thoughts well. as two as think perhaps get then been checkpoints sort additive, see is when cancer, combinations feels synergistic love special really didn't especially we its of, additive on in quick to there own cancer And there discontinued to I'd current like to combos former meetings not Obviously, in-person were around happening. a

Michael Morrissey

the about speak a synergy to the S-word - maybe maybe high We Peter, you Yes. Thanks banter want that Peter time, at level. could question. the briefly all for to.

Peter Lamb

mean cells why roles of and reiterate mean has in play just activation showing we're impact of scientific trials that positive we subsets from and data the and leading peripherally with and point that have which of Yes. AXL, and and obviously why cabozantinib immunosuppressive starting clinical immune cells activation number innovation and cell variety some certainly on important at essentially I look think a to cells seen it T data comes includes of target they to CDX of we're clinical MET, combinations this VEGFR, I Tregs also rationale been regulation view of variety as at well of if checkpoint NK what you I about microenvironment, least a cabozantinib pre-clinically. do as like is we've see, MDSCs, I'll in a excited the the inhibitors that the to profile has tumor down

immune where that impacts of tumor totality that and in it's on think system strikingly the profile, XER into that's the I the data feeding have adaptive we on the both clinical we and So data. and emerging that's have innate really impacts directly

Kennen MacKay

ASCO. lung of at as could maybe Again, understand where or maybe then a saw get bar patients standard the lung the sort COSMIC-XXX obviously follow-ups to similar hoping just on see what for they patients, title And bit little the clinical care you cancer, these of chemotherapy.

patient And the you a same of are this as of non-small different population going of be population a how cell bit cancer to little XX, hoping then thinking similarly, the of the space. about expansion sub I'm COSMIC-XXX or understand sort is contact may to that considering lung be

Gisela Schwab

the rate bit Well, in off and and look of on response, of Sure. XX% of between you the and earlier sort other mind work think I it's plus I of list discussed that these of at there. now, course, your general, make for response but all particularly and is can same ramucirumab as the long points chemotherapy somewhere not yourselves we there, think up or in XX% little benchmark data or the, a a combinations or you mentioned out number chemotherapy in that benchmarks there

similar subsequent on patient Regarding looking trials the require the the appear checkpoint we're at we to when chemotherapy XXX, ready. in patient in and certainly XX, receive or in will it population that will prior a combination inhibitor will strokes, who context lone for or specifics broad-brush patients clinic be in population

and still under the won't let time comes. that rolled I here be this out so and when And

Operator

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

Stephen Willey

opt point, that previously arm like well. a into I'm novel for as the little, and bit Phase of there thinking option this presumably and you think X what how like respect anything ends asked question with my of you just so we about probably previously to but hopped on if selection looks might chemo been and and control an maybe prostate, used talk a I for a as get a you could taking hasn't curious I were just design XX, here, as questions Thanks can little the repeating just when ambassador at about apologies the you're insight to contact hormonal an have trial salvage

bit if the can just walk control specifically respect that peaks with kind is if a perhaps through control arm your kind thinking then anything of you're and to you little selection it. how arm us that there interest Just wondering of ends within about selecting

Gisela Schwab

Yes.

this is So, Gisela.

for PSA response effect of X building the and course In rate on XX% with durability the on generally good cohort seen of of and signal ASCO been consistent what that terms response. it's we're has responses of strong

that this control variety you've because So we're the many would is certainly them, cancer is opportunities, of patients potentially Phase opportunities thinking that's mentioned and prostate patient NHT there control choice the we're regarding as amongst of what novel value in is it them arms possibilities, options. chemotherapeutic trial on X at deferral allow or and as it building population, - and

are So the being and forward, and on able to in summer. account, anticipating working on that's we - they're when and more hard will about taking forward over think detail certainly speak that a study moving consideration to when it it rollout, rolling the I in

Stephen Willey

maybe days script insinuation patients probably just change are That guess And maybe quick number XX than that Okay. P.J. prescribing that who makes enrollment. in your guess relatively specifically the remained make easier of stable. respect or greater Any a And one patterns, just then agree getting to I with for for one I would with filled general I sense. has

Patrick Haley

Yes.

terms strength with seen, we've everything I metrics second with line consistent normally, before, in there new the now think we're the can remaining as the in of with customers what helping sort we're Exelixis team terms we patients Access doing generally of of growth, but certainly relatively our Services. in share business, other mentioned patient seeing pleased particularly they and and

drug we're that. sufficiently patients and certainly to see continuing gratified by So get

Operator

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

George Farmer

I to talked And that longer over year hope this be about that. quarter there. not of then think last weakness. frontline had we at ask do on so, and revise the end about to had sales you backlog, like that seem I'd that well you a and being have been is strong everyone contributed with the then guidance why you through the follow-up. may I - therapy just given CABOMETYX have patients if we're relatively to Are

Patrick Haley

Hi P.J. George, this is

we terms being coming in and we terms think have in that we of for first of terms part I now have after line in the year of in patients combination growth seen overall as number that have second monotherapy TKI in really right patients, latter of survival line coming those an setting. talked of of the trend only line, the now, majority sort that the the stabilize ICI into ICI kinetics we CABOMETYX CABOMETYX about and in saw the, second last a pre-treated of patients those where really where benefit really captures the

of the kinetics patient trend of we flow And of anticipate line. of continuing and in that of just frankly timing second would in terms the sort we're to the sort given think I those strength the starting see that beginning

Christopher Senner

Chris. it's George, And

reduce - is in it we the so question, out, in guidance - grow year, early that, and pretty continues had and inventory to that demand as number. that the quarter second-line that the still the we backed talked you the would on that about, So had if could build it's annualized P.J. strong also

lot in of around squarely the I'd And also and guidance pieces, so pandemic. so particularly overall, say we're is - that doesn't include COVID-XX moving range XER middle the the a of there and guidance

we So we're now. comfortable are right where with

George Farmer

RCC with And comparator field cabo the trial is in it's is I trial of is whole trial approval. crowded in then evolving is with Roche for Phase do regulatory looking kind regarding noticed the on this your think atezo setting, in frontline getting you that Contact XX, and this sufficient how this X cabo, at is clinicaltrials.gov alone, comparator going to and be certainly the right cabo this given

Gisela Schwab

Yes.

let cabozantinib. and and I really paradigm think on, care is our is think RCC treatment that and standard I the a is signals of what atezolizumab backbone the study on second leading as the what that's of alone addition cabozantinib building it of setting and the

being So comparative Roche the a with been I it's registrational is and by study being appropriate absolutely sponsored is designed - do designed think certainly and has intent. and yes,

Operator

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

Paul Choi

CheckMate first and trial My the the see it's And in not into the the of saw built back earlier that possibly is just the on half of data built of remind COSMIC-XXX to final maybe then question the I or there is completion look all plan just an that interim is XXX, the a can us year in the with the primary you way this if trial something through and - given you question robustness have lung. see we the follow-up could of year, ahead to on result. interim

Gisela Schwab

progression-free ones. Regarding survival COSMIC-XXX, that would then rejects the the this the is and first analysis of of survival the underlies the analysis an would design for same for strategy survival earlier hypothesis primary the the - and unless that further analysis build as analysis that at for in an overall study one occur a is require study there interim time event-driven as

and terms really is and on when is prepared certainly dependent in the timing, events be entirely we're So monitoring it of closer. event events the getting count we'll

Paul Choi

of lung is triple had your topic for a of have for for proves questions. for comment partner and plans in to you're taking you which and you whether triple then our your that this cabozantinib while, kick a Contact the the the year trial, clinical combination then Bristol how that you still there the Thank you the against some off the just the can maybe trials second-line much trial listed indication. trial frame a involves ipilimumab, ongoing on nivolumab, if like would that. And you of on Phase Thank lung, plan and X trial potentially and and CheckMate planning XXX have to very XX response, combination,

Gisela Schwab

Sure.

the we'll we everything the sort sponsored X BMS. initiation first is And regarding of moving said, are trial by study XX clinicaltrials.gov expectation we speak. at stand study is from kicking is see the as data And off a and is forward at done this as look XXX, question, we've study And that the both listed COSMIC-XXX dependent, towards but the and in cohort is Contact Regarding there. second you is that certainly the ASCO.

at is everything of sort parallel forward So marching point. this in

Operator

And your with Hung the of line question final comes Stanley. Jeff from Morgan

Jeff Hung

weeks, congrats you has a improved on can teams recent you virtual if the that been have And and the changes Can and taking I metrics they've your on about follow-up. talk for anecdotal questions in frequency of appreciate any experiences this commercial such with anything then touch and as I share. interactions Thanks points field healthcare with professionals XER. there observed have

Patrick Haley

points P.J. is have regards supporting we a in efforts or the and what guess feel the the have This virtual compliantly. providers with yield I'd we've pleased I from pretty to sort we about experienced the of good say to conversion ones. team of we're and team patients is, that seen, in-person appropriately we With a certainly touch what healthcare

basis market on and we're planning and really, it's everything but seen converted - do we ends, say RCC I virtual the as has And vigilance our in a obviously because secondary a by where of and of dynamic them we're to employees place the even doing patients some obviously research local been the maintaining of of a to it's the well. team things and of I while think years, small lot our local are early than the and of that is in support calls albeit it's all team that for - more appropriately is four customers seeing can our on experience we've should health the more fact this most, person,

Jeff Hung

you substance make kinds longer stock of continues than drug a about Can can for of talk then you and time. manufacturing long modifications, And and are for have that of sufficient drug with means expected. supply COVID to Thanks. commercial if for levers safety inventories substantial period what you what kinds products

Michael Morrissey

Mike. and it's a Hi, have supply various robust stored - regions positions with look, stockpiles Yes, Yes. of at we process. regions various for the deep various intermediate in very chain cabozantinib at

have So stock go. we literally ready hand, of to in years

here but whole further that's but also as now supply we in primary second that coming expect the covered the online CMC - and growing have that So drug reinforce supply off the a team coming for really and supplier have number secondary for years, well chain both and indications in substance supplier, only that got heads to to drug further product the investing not really we to we augment of chain. supply

So tablets as well, long stability of API and drug both and the product in both capsule format.

So we've well. pretty Thanks got that the question. for covered

Operator

At further questions. this time, no there are

so, Ms. call Hubbard. back Ms to will Susan your Hubbard. today, And host I the turn over

Susan Hubbard

and today's Anita call. Thanks answer today. and all are participation very Great. We your left for us any on Thank during Be again. that were you, joining thank unanswered questions you appreciate standing safe. really by the much to call

Operator

gentlemen, this your concludes and and you Ladies a today's you have participation, for day. wonderful Thank conference.

all may now disconnect. You

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