EXEL - Earnings call transcript Q2 2020

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Second Quarter 2020 Financial Results Conference Call. My name is Gigi and I will be your operator for today.

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

Susan Hubbard

and quarter for call. XXXX Gigi, the us you second Exelixis financial thank you, joining all for Thank results conference

the me development P.J. Chief will corporate, are quarter CEO; call June Peter Commercial, Lamb, second our on who our Scientific Officer; progress Executive Joining and Officer; financial, XX, Vice Chief President of and Chief Mike Medical our Chris our ended Officer; commercial together Financial Morrissey, our for review our and Gisela Haley, Schwab, XXXX Senner, XXXX. today's President

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

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

Mike Morrissey

right, components All on joining all business. Susan, Exelixis the second of across thanks for everyone to had thank our us a quarter call you, strong today. and

priorities quarter. execute use key today’s important from milestones progress throughout the for continued of our year. We and XXXX provide momentum to as highlight off to build achieved additional on We'll we the the the call and rest the half first of perspective

press today's organization our of as remarks from list As see Please in our our your was and top-line results recent issued quarter second will XX ago first-line combination in States on pivotal filings the priority virtual trial the late Exelixis’ excited We're at be we're RCC. to XER high detailed collaborators, future. August. to September. evaluating the commercial cabo/nivo address the minutes update. was Phase XER, ESMO The to global the we'll CheckMate in near and the in with calls, the III release short our present for Along part main our The the United accomplishments. extensive regulatory prepared highlight positive XXXX the of keep an that end of results in complete launch questions the corporate track financial quarter key of for ready results meeting by

and work we important growth key top for discovery opportunity development Our commercial while priorities, to progress first expand utility cabo’s additional oncology as next advancing our We've line RCC and remains the indications. made cabozantinib. and priority also

the TKI XER, year atezolizumab, in cabozantinib presented program. III combination Importantly, differentiated been indications. three The early data can as cabozantinib of new of lung pivotal meetings various CheckMate coupled in liver, cabo success for trials compelling read-through prostate, with efficacy the unique part recently initiated highlight trials ASCO trial in current play and this new important global that the cancers and encouraging pivotal provide role signals may for CONTACT have and tolerability These potential at combinations backbone. Phase with clinical of as of bladder IO a

up a track INDs as continue three the of business of end file forward Exelixis’ our by challenging our we're focus our drive by Finally, new of these incredibly work this efforts we of proud year result times. during to partners. commitment to the I'm the the on displayed to entire and internal and team as

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

Chris Senner

Thanks, Mike.

Total second in cabozantinib Net quarter reversal the the Takeda COVID-XX the the revenues in included customers quarter negatively general revenues XXXX Total product and by company of net of For the quarter XXXX, $XXX.X of revenues second Ipsen, million. pandemic end franchise by also XXXX. for $XXX.X inventory million. revenues Genentech. wholesalers of by included quarter total and and in reported were of product million the collaboration from the built revenues first revenues $XX.X impacted

fully R&D driver second increase quarter XXXX $XXX.X the rate compared and full was for in commercial expenses. The decrease tax million increase by $XX Cash trial quarter operating cabozantinib. $XXX net XXXX clinical the to to was as income or impact the XX% quarter quarter reported share income ended $X.X to we investments to share compared or a on $XX.X of basis approximately approximately effective for quarter for reported increase the of during of The Provision million, the in and increased net GAAP first total million was second million the offset a expense R&D for diluted and effect. $X.XX by expenses the and million expenses was for potential the $XX.X the second June the per continue by the fully for company and stock which expense operating of excludes $XX.X in The was taxes billion. approximately to total per invest expense XX, Our tax our primary $XX.X net and partially of Non-GAAP approximately over basis. million income compensation XXXX. quarter SG&A also $XXX.X income of XXXX. of of were XXXX first company the $X.XX quarter in based million XX.X% clinical XXXX. on net primarily of million of increased income in diluted maximize related expenses, $XX.X non-GAAP of of related million

to our turning Now guidance. XXXX fiscal year financial

billion we executing of expenses R&D this We're the compensation range have which expect $XXX increasing of million, $XXX and to in and million of non-cash finally, that, corporate activities. impact we we Research and $XXX pandemic to marketing be compensation milestones And revenues between we're the stock-based over projecting and million. guidance primarily range development expenses recognize Gisela. therefore of the expect our our are million supporting not continue Selling, fluid range rate turn now the million goods the product in to incremental the investments expenses development earlier we revenues. are I'll the goals which $XXX to due is XX% the we total which in product $X.X is primarily and be in revenue of and launch and forecasted and related With and on to difficult potential cash $XXX of and are million, be higher licensing reimbursement financial related increasing $XXX million. million in XXXX sold be does XX%. of stock-based predict, are to net approximately for in new of Cost expected to While This $XXX impact year. expected to administrative of able in costs, approximately is both of X% to be to of the due increasing COVID-XX potential higher $XXX been tax includes to $X.X revenues. provided expected to effective updating to million to and and XER expect due be includes and include is the Net to non-cash between and general $XX are to billion. be to decreasing million. $XX any range are guidance expenses Guidance X% and cash range guidance, business expenses investments the call

Gisela Schwab

an Peter. for and program before of towards progress I'm on development progress over and positive of compounds late since pleased Thank provide Exelixis. the I'll IND start regulatory April a update were to results lot CheckMate We've with in Chris. you, our handing cabozantinib new made top-line BMS to XER. announced and

three As a this recall, efficacy endpoints, the sunitinib benefit demonstrated response and free survival, all objective for overall survival including progression over you rate. comparative significant study

cabozantinib combination with of XX-milligram tolerated low discontinuation at well associated a Additionally, generally and nivolumab with QD rate. with the

for NDA intended occur cabozantinib to are Takeda filing. sBLA. very productively over filing last with happy completing filing in of the concurrently we On the we regulatory supplemental I'm have advancing is close to the our and been towards combination our of BMS’s basis team and and The results, with activities line of to these partners months the BMS the RCC. few treatment first at the filing working Ipsen very of nivolumab the say And on the

the also are enrollment and at the patients from been COSMIC made COVID progress. virtual detailed impact March the and of the we We pandemic continued also progress cabozantinib have study the rapid CheckMate Besides and with XXXX. modest to Genentech program the presidential the for is temporary program ESMO study in XER, have in of upcoming has execution ongoing study Phase Roche. forward start looking up results III our conference contract of the screening III Phase on April, slowing of symposium September to from the on efficient late our able this the and presentation also Despite

milestone of COSMIC differentiated reached trials, response half to second XXXX. in analysis planned And thyroid are of XXXX. our looking forward objective study rate III patients of in of cancer, the RAI-refractory co-primary COSMIC-XXX, we the XXX Phase its the endpoint the of and February enrollment Regarding

data primary continues patients. untreated first COSMIC-XXX, with HCC only HCC now analysis. its for sites planned to of the completed, we patient cabozantinib screening other China, enrollment time we completion Maine's XXX to enroll to Global in of patients will local enrollment the in aim at global endpoint the enrollment study Study the registration driven patient in have and remaining support open event- progression-free necessary With of providing. study The sorafenib with survival. where comparing our enrollment this completed to line atezolizumab advance to the Further, number enable Additionally, previously are the

executed the XXXX, XXXX. is to in first achieving China being the separately. in expect and event half of Based we rates, current late analysis enrollment on required top-line occur in XXXX, events anticipate While early

enrollment triggering number for fashion blinded we and closely a And are forward Ib or the RCC enrollment study will events and XXXX, our first COSMIC-XXX of And planned early or XXXX closer the large III poor and in to are more frame. in when continues atezolizumab, the get of from results We final event analysis Phase Phase previously guidance risk OEs both study for intermediate time analysis to the continues COSMIC-XXX, to to globally. event-driven provide in with the XXXX in for untreated expect complete analyses. once PFS analysis tracking make the PFS refined available and lastly, late the in Likewise, cabozantinib interim looking we trial patients progress.

progress, in CRPC COSMIC-XXXX metastatic cabozantinib that cohort ASCO. of metastatic CRPC cancer. CRPC GU Roche, address contact as X, been upon itself in a cancer. CONTACT-XX evaluating therapy. earlier reminder, studies inhibitor and in Phase non-small our enrollment, renal path the and support enrollment encouraging year Genentech and have depend and Phase III further non-small initiated, made cell which cohorts with of checkpoint And particularly from and metastatic the atezolizumab cell good lung and now ASCO in This and single-agent inhibitor cohort X, indications. of cancer results yielded contribution completing cancer. metastatic cohort CONTACT-XX the presented lung three CONTACT-XX MCRPC cell have pretreated of patients, pretreated inhibitor is These close cell supported the checkpoint including has with as hormonotherapy non-small in Also III lung FDA. accelerated discussed combination non-small have results cohort will the X can Importantly, approval Nobel X pretreated and cell evaluating results initiation and components the cancer other of lung cabozantinib the to activity an at checkpoint three program All pretreated CRPC atezolizumab to were

the completing combination single pretreated For non-small cell further lung agent corresponding evaluating cancer X, cohort, expansion. inhibitor cohort patients the rating checkpoint enrollment also the evaluation cabozantinib are close in in potential regarding and to

good together and are development our who partner's our the conditions world clinical the thrilled cabozantinib progress various we been execution due this times efforts on pandemic. able well progress as we significant the global good and Likewise, quarter, regulatory teams XLXXX both of program teams, on with to by program. on of around back and the Looking despite the IND-enabling make various as have challenging to progress the making own and are the level progress

Biologics cobimetinib close, The For IMspireXXX, approval in that the trial of treatment the end programs towards of BRAF And developed XLXXX, to we start regimen will as are And that and Genentech companies. with or we by And importantly, evaluation quick of moments. This basic RCC demonstrated by the based cobimetinib which IND the the worsening on vemurafenib. that being like part we to III the non are fall previously And worldwide from presentations filing of a placebo conferences, discovered finally, clear helped end July second year. to FDA update ESMO especially and Application XER. candidates, cobimetinib. risk vemurafenib patients. and cobimetinib I'd plus disease Genentech to to License for atezolizumab cobimetinib, COSMIC-XXX melanoma combination before reduce And in vemurafenib pivotal advanced is agreement of well our inhibitors course, on will from and two to to of for in positive forward into I as, death roll data of the plus on NIB submitted untreated working expect and approval months. the the the approved regulatory at detail compared few coming provide that include call RCC the for adding clear for the is over atezolizumab looking copresent will the checkpoint Peter we XXXX, mutation-positive cell results a CheckMate Phase collaboration a FDA a cell that, with containing to between these sets more in is Peter. supplemental a hand as IND At

Peter Lamb

Thank you, Gisela.

So I'm expansion assets. development on update happy and to provide brief preclinical our pipeline a

making to team early following three-month network thank stage employees. our flow this immediately stringent to and data work our to Aurigene our exciting resume, on we a after I'd at discovery like hiatus to of particularly to resumed this members laboratories see happen. we discovery continued once all partially has CROS. progress making programs, COVID-XX, for development at of take Invenra, It's partners, First, due protocols the at now Work and and our have to protect again opportunity has our preclinical the of discovery Iconic, advance as work are

we four nine result, months. next up opportunity the have file a to the As in to now INDs

iconic laboratories previously inhibitor this conjugate focused origin As antibody to we our three may INDs collaboration, TAM discussed, of CDKX kinase XLXXX collaboration. internal drug file from these from targeting a a from tissue year, and factor up our a TKI

action the with Aurigene half on from plan presentations, in compound additional inhibitor could XLXXX, to first an which I is next-generation in a With into met VEGFR next advanced additional that novel provide development, respect an upcoming year. we present potential now to year. IND data have pre-clinical this our later We trials currently Phase of mechanism of

get a ADC conferences advancing program from have We'll development and acceptances. We on on provide number targeting had PDLX factor We've perspective data our details be tissue the a abstract business and to and CDKX plan as our preclinical a discussions. antibody a quarter to is very of three CDXX. assets scientific busy inhibitor, the bispecific more happy we clarity which present specifically with year, at this Invenra, also of lead

emphasis both we effectively space, the opportunities in near for path which and or assess find see a biologics where compelling to molecule to scientifically and small programs. an and continue stage clinical commercialize clear develop we We forward us on clinical with

come fruition. of forward internal provide over exploring potential to updates exploring I'll going look of as forward these addition, to In capabilities. the discussions call and platforms that, therapeutics PJ. that BD And our to we're a discovery In turn variety they we're flow have to We complement addition, the providing with additional that a on novel

P.J. Haley

the to I'm one remained you, continues agent TKI CABOMETYX context now performance XXXX. the Thank quarter QX the checkpoint for to which RCC, business three in line immune largely prescribed despite single in commercial COVID-XX a second Peter. the or stable pleased first number combinations. be of review of is the The CABOMETYX in pandemic. competitive which market, notable includes ICI inhibitor

the in the the orders a QX. with see Trx RCC system. weeks performance of reversed are QX we share consistent been has stable in relative case and our in pandemic. well and the segments And to therapy XX% This as trend shelter obstacles across modestly we as dynamics the QX, The of may the new June basket. by a has was the access prescription Demand remained phenomenon QX. that both wholesalers following on to regards key as to mentioned, and in result CABOMETYX new at this pandemic share Market as As health reflect that was with initially care believe was few with to starts Nevertheless, pleased patient believe a Cabo reversed decreased HCC. end did We CABOMETYX May. QX. in the since market in created on and of seen in trends the share, impact at in was it biopharma competition largely nater customers market in inventory the impact patients’ was market of in trend stable. ability pandemic. beginning other remained decrease generally both Also, a with this in QX the companies built QX, initial Chris in the there we quarter, reflect patient as place in a the

QX. a decline there Although basket market TKI was in the overall small TRx in

Our providers U.S. this calls team in of This guidance, future the programs, franchise, we to health maintained protocols. the customer phone limited by excited with speaker of to that share the virtual appropriate, duration the has CABOMETYX to be treat our end therapy of grow cabozantinib facing were regulatory continues shelter patients to through ICI in with relative The CABOMETYX has necessary on share of of field who are the the large, opportunity recent tactics. CABOMETYX to market since study of in of At us pandemic consisting compliantly the in these for XER with conditions precautions teams In hold pending interactions relative the a place XX% the and we in digital the quarter, line. market results, Throughout provide supporting resume focused first the on setting and may the if combination first-line did opportunity approximately CheckMate the looking increase believe we and care is able the quarter, voice basis, therapy to that competitors. outcome share as in safety the our ICI local setting. taken approval, combination person

The line ability setting top in KOLs in have efficacy, effectively that we the we market in has the As over first-line setting. and positive RCC. the and knowledge combination, and assuming cabo/nivo therapy our on to regulatory that with received of feedback tolerability benefit have we in results appropriate physicians more to again, in now deep the been educate XER our cabo/nivo very the have with in data the to opportunity the experience doublet, look on been this regards compete years, CABOMETYX forward to the this hand. approval data so patients at to we has confident from safety are opportunity four of time for first-line this And team from

will the is patients line from by of XER, first launch-ready highly for CABOMETYX preparation, great to have of in high motivated potential first that in very we monotherapy we and launch eligible a progressing believe, while of currently will to to population At will will the remained growing market ICI-based line simultaneously approval With CABOMETYX focused combination team the for continue as duration, stable. monotherapy. We capture and CABOMETYX on end CABOMETYX and pending in continue second August. to same the be regards patient that terms Our second line, we share U.S. time and in in be be fully the there share the HCC, therapy business line. grow percentage in regulatory both launch

HCC anticipated, therapy similar combination early in As the to received and and bevacizumab evolve with market what of will the of show regime. data fashion saw first-line the atezolizumab in in The likely we approval landscape QX combination HCC the uptake a fast RCC market, ICI for market. could to monotherapy cancer this turn, be time. the We to as TKI the front standard of in treatment-naive setting, anticipate care use important an over which serve patients utilization moving second-line new increase the line, liver decreases second-line ICI will, in first-line in and monotherapy expand

presented a with to ICI CheckMate COSMIC-XXX the earlier data HCC ICI partner, of will we on with potential data franchise. combination year. and opportunity represents different to look next growth atezolizumab combination III XXX the build further this Turning cabo provide Phase in CABOMETYX another for readout to forward combination the in

in cabo the CRPC based could RCC, of be the the next Additionally, studies been that NSCLC for highlighted were longer-term previously, presentations in wave pivotal data that recent encouraging and including announced. driven trials growth combination has recently and contact in on cabozantinib-atezolizumab by

inhibitors and RCC, different many could prescribed, look in strongly solid further RCC, patients build number HCC expands momentum eligible more evaluating such on believe data our and malignancies progresses. broad This has multiple prostate program to and development Additionally, combinations. exciting provide study, readout, in to combination benefit the growth. and forward remains first tumor combination potential expands ICI cabo program single-agent this indications, immune first COSMIC-XXX this checkpoint patients market RCC, many lung, the as CABOMETYX one other and opportunity to as in The the franchise. the the we RCC, investigating the benefit of forward from and potential cabo potential as building to that we cabo/nivo/ipi, in continue future to XER across to the we with cabozantinib more in TKI from Phase trials in combination line development the of first many to CABOMETYX. to triplet look bring We X is

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

Mike Morrissey

Thanks, All right. P.J.

pandemic At said to to the to quarter of in last I months. recognize half the we As today’s clinical and first QX same opportunities. momentum severity, the time, several as sadly XXXX as the intro, a we we business and are had the on second from of the a we’ve in strong over risk the our should commercial, seen on working build range grow acknowledged call, continue over discovery

priority. We in safety will employee our continue to with these patient push highest and always health forward and times challenging

you develop patients entire next-generation one of day our you your in now almost home our working their all and everyone happy every as by at need better efforts Most thrilled of additional energy. data-rich the a have are we and expect is and second questions. teamwork, team XER on cabo majority The advance more under, on are in team to ESMO. medicines. dataset across interest conditions. I’ll for for great for and indications for making progress has the open months in look building for challenging Exelixis we’re skill call quarter commercialize with five now Exelixis our obviously, XXXX, of count cancer components to in over presented success, as support cancer from medicines and We as and Thank we portfolio continued CheckMate and working half of the future. our We importantly, XER been next-generation therapies. and of to excel of business we effective continues close for on complete investigate the Exelixis, at updating the thanking to The a discover, focused diverse forward Exelixis

Operator

first [Operator Our from line comes Instructions] question the Werber Cowen. of from Yaron

open. now is line Your

Leo Ai

Yaron this Hi, trying for IO categories is the the you – RCC just IO/IO combos. the is I’m Werber. that mentioned risk on I wondering for regarding share in – data XX% on are our were have on the you dynamics. because, the Maybe how XER split just to specify can quarter. segment? I thanks comment competitive first-line of first-line can risk all on questions. question taking you favorable RCC. in comment Leo, And share grabbed you market Can Can between guys great one by Congrats you categories, in that guess, you IO/TKI? and the the differentiated

P.J. Haley

Yes. Hi for is question. Leo, this P.J. Few there. the comments Thank you

mentioned, talked RCC And As and we’re combinations split we’ve detail applicable intermediate our share the study those. did we’re first-line and And see risk half clearly yes, impact mention, approximately patients. great confident as oncologists. all really to poor – a and data across we’re all previously, that you XER upon categories, and utilization with roughly to have of to – can risk. and really, those it really XX%, both about And of broadly the this both data. going it’s for approval of excited position combination be the think IO is customers first-line in market design as what we data able really really with share pleased between in dataset ICI it’s I That ICI/TKI ICI is in or IO/IO. broadly with favorable, And clinical and said, I think, all

Leo Ai

it, thanks. Got

Operator

Thank you.

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

Your line is now open.

Asthika Goonewardene

you, Hi to guys, start thank you for please. with taking Chris, my I’d like questions.

there’s the just was customarily wondering XQ? I’m if in Just couple a back then a And for net is I bounce gross a to got know second checking, we others. what quarter? cabo from little of the what weaker less

Chris Senner

Yes.

is This So okay. Chris. Thanks, – Asthika.

in range first the D. in the because Medicare Part quarter it’s XX% higher quarter, for So slightly the of the

As I between XX% call expectation future we is the said in XX% for to to our here. and were during the as gross for – look fourth net year quarter February, we the

Asthika Goonewardene

we the one I launch then have line. what then I’m that atezo/bev for question I’ve guess, And is guys you. thank final after it, in evaluate like And HCC looking if are market got in you did? wondering, general, RCC to, Got evolving first in that. HCC

P.J. Haley

Yes. talked in and Hi HCC. what the and of May now see to question. combination in that is frankly think anticipate beginning atezo/bev, Thanks data first-line we primarily HCC, is into to setting Asthika, the subsequent the this with approval regards move about the With I quickly we’ve for are P.J.

in setting, ICI first-line is So in combination patients what to therapy happen potentially pool relative receive local things a the systemic are few think who to first-line, we and HCC. of the will will therapies that standard regional that other will the able therapy patient a of care will do in become expand the

we we in XX% that growing our TKI look broad is being to the second the really to and with the data which second quarters with study and really forward compete well HCC first more the as move from appropriate COSMIC-XXX has in regards second-line setting share in would then large CABOMETYX to in overall setting. in for opportunity able market. we that and compete So survival few create for line, results about the think I/O, which Also, see line last that will line monotherapy positioned to to

how we of over of kind that’s So years. evolving the couple HCC view next

Asthika Goonewardene

ASCO some thank got board you Great, us to minute. cohort a through would you mind walking for ad you. want the take then at X. And of feedback Guys, just

Gisela Schwab

You’re lung on cohort was at the talking XXX KOL that ASCO, that? presented from feedback data about the

Mike Morrissey

Gisela, you to take want Yes, that sure. one.

Gisela Schwab

question. the for you Thank absolutely. Sure,

And of cell rate. so to inhibitor was And from are a cohort, lung in the the lung cohort patients. combination quite this durable patient was importantly, everybody atezolizumab. evaluating response therapy, we And study, setting. COSMIC-XXX the checkpoint responses pretreated combination and a this are the where and remind non-small this in pretreated objective chemotherapy just XX% population cabozantinib quite And objective with that these confirmed in were cancer

and that cohort we’ve very you are have various cohort. these seeing that in we as the And I was received this feedback know, are another in think data feedback expansion to more and expanded since close encouraging KOLs intrigued by that patients from and were the the enrollment completing cohort. – from certainly XX interested

components single-agent address the the of evaluating of study. framework also of to question the COSMIC-XXX contribution cabozantinib in We’re

information I more have forward providing it. to So look we when

Asthika Goonewardene

Great. for questions, guys. taking my Thanks

Gisela Schwab

Thank you, Asthika.

Operator

you. Thank

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

now Your line is open.

Peter Lawson

my thanks taking for Hi, questions.

data, are aspects cabo you’d go you that highlight there point And to of initially? that help us are the Just specific XER after that ESMO, kind risk on groups particular any differentiation? data there at of that

Mike Morrissey

first-line data a Hey literally up for sense novel we a for very how do. I comparisons the would and you’ll guys you very and Yes, all important, that every do Peter, Look, and it a good question. you’ll want data combination it think in be setting normal stacks it’s that across normally will presentation, the them your fulsome the as point obviously get Mike. believe is thanks

it’s context that all but I important look the – ability to the in its an totality – So at the would data population. data. in take of of impact to It’s have that

in I had we think, certainly it. a about And data is can good we’re So what the back April, for excited in the expect. you segue X-K very

stay So tuned.

Peter Lawson

initially you are you you. particular where easier be after they could there go to penetrate? feel subgroups Got And that

Mike Morrissey

Yes.

first-line I think said previously, data based based a going and very it’s the strong, patients is the competitive think We think as in we’re all – we P.J. offering. that to target data it’s the setting. on

Peter Lawson

it mentioned, then in any a impact temporary you and QX, mentioned. related? then P.J. Or that talk like just on XQ? for picking in TK the decline And it’s Great, some And can Is you. COVID you XQ is of The expectations is up do in I through think, overall market structural? think there COVID issue? thank that you

P.J. Haley

Hi Yes. this P.J. is Peter,

TRx see what and the – prescription market there’s X% basket high. data, today. I quarter-over-quarter, we but things. QX all, QX really variation talking is about – for some It foreshadow QX are I to regards of of I those say So won’t since down first was historical won’t here the couple prescription is total there. What a relatively always was QX with would we

the So it year. last sort the really levels return even in though to the standard prior quarters, down, couple what of was of it were

generally, structural to sick with So any very disease. stable because ball, a metastatic COVID, patients I’d any absence these of don’t it’s impact obviously, long-term say are and anticipate really due crystal

Peter Lawson

COVID? cabo XQ, for in then you from And you. what was think, do the Got impact,

P.J. Haley

Yes.

saw new in there. of decline prescriptions, as I a see in which we health providers, going we that care the same June. we’ve something think, And their to the TRx, heard across as initial what folks industry, into in and not were did is down recover So sort in really earnings discussions the saw we in shelter slightly, place, it was the X% market, just

but and be generally mentioned business the stable, of that. some really, the and I point to small So impacts, perceived, metrics kind to all as

Peter Lawson

Got you.

much. so you Thank Okay.

Gisela Schwab

Peter. Thanks,

Operator

Thank you.

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

now line Your is open.

Jason Gerberry

the taking for Thanks guys. Hey, questions.

Just for me. a few

like about to market First, million being you I XQ struck me trial Roche’s opportunity low, a patients million narrowness States. a into on the but systemic inclusion as heard of TACE, like to little about was proportion factors moving that the can a bit guys it a call perhaps in $XXX of United there that. frontline lot comments are And curious, HCC $XXX number of therapy IMbraveXXX over the go that, versus criteria,

curious you fundamentally cabo dispute, thoughts that? had think have that you in alternative companies opportunity patent cabo out just then of than generic my curious, around a sought regarding larger could the question, And So much terms second number patent be a if number forms. any protection bigger I’m market of it salt if

or understand. bioavailability you should to the if curious and/or lack those And forms not for its NX any NX form I’m companies necessary like those able if have been to salt form, I file stability have – Thanks. would views applications characteristics? to ultimately and they regarding say, That whatever And cabo so be generic reason. really helpful not inherently guys degrade

Mike Morrissey

P.J. some is the first and Yes, Jason, thanks. provide We’ll second. This answer commentary I’ll on Mike. the question, have

P.J. Haley

Jason, Thanks, Yes. for the question.

over So is a XX,XXX, pretty of in right, in we metastatic guidance amount I’ll comment forward, we’ll IO/TKI study price, the of would of to one the cetera. I increasing regards first to that therapies that of see U.S., I the of there. we to gradually therapy, a it, lot XX,XXX or the into ballpark but that patients, as of number mentioned, time. go have if with couple will duration large what certainly that, the et XXX in With a the a wouldn’t We obviously, another regards positive potentially see have revenue move data And as that opportunity, marketplace. better on as in I looking way patients HCC into years disease But view patients, say want that on it’s opportunity. compelling market, in story opportunities, the that opine presuming Roche’s the setting. do United States things

the and So there. about that opportunity the that for a have large franchise we would significant think we’re cabo certainly have of help excited – amount growth patients to be

Mike Morrissey

Okay. Good. Thank you.

of statement filers, there’s terms other a for into to form your of then the many that commercial factors selecting clinical play question forms relative obvious, In scale salt and in about utilization go ANDA certainly, a and large-scale up in salt efforts.

a up forms that at on don’t then obviously, lot chose the a did to chose all out to We the opine But and go want that scaling we that reason, the very well. of we there been reasons the say, there’s salt for we’ve that So salt reason. polymorph right in certainly obvious other as now picking into successful for a form. malate both right that I and needless form, commercializing for tests

there. ahead steam full So

Jason Gerberry

guys. Great. Thanks

Gisela Schwab

You Jason, thank you. bet.

Operator

you. Thank

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

open. Your line is now

Michael Schmidt

taking one guys. with few. about I questions. the for a starting for had COSMIC-XXX Maybe study. Hey, Gisela Thanks out my

talked I mechanics number of around and OS some think about reaching the and events. of the enrollment you PFS required

potential that the analysis I any in rate? on provide was if based think And about I wondering that’s a you’ve could front. past, if you on planned? talked interim response still additional information

Gisela Schwab

you, Michael. Thank Great.

always co-primary to analysis planned are there of And for no OS. objective and that PFS the been your has designed interim question, or COSMIC-XXX with endpoints matter, rate. response PFS for So

for statistical planned are analysis plan. However, there interim overall analysis survival, in the

tracking And the fully OS the we’re interim for and PFS OS. so that events, analysis events, is both events and at towards and now analysis first and And final the is study former those of that looking tracking enrolled ongoing. for these PFS course, for

Michael Schmidt

on COSMIC-XXX. Okay, DTC, then great. Understood. And

us made in up. coming market Could of thing near-term that’s of kind some indication? another you help maybe the just particular that’s assumptions understand that in that bracketing So you’ve potential the

Gisela Schwab

Yes so – sorry. I’m

Mike Morrissey

P.J. No, Gisela, and from don’t start ahead. Why can pick you there. go up then

Gisela Schwab

failed that who the prior Yes, trial therapy. basic It’s start design. have patients just cancer, have radioiodine and received and also study in I’m then who differentiated a to have received happy with thyroid randomized VEGFR-targeting placebo-controlled therapy

survival. is rate population. co-primary enrolled we’ve and study been And response patient pretreated XXX based objective be endpoints achieved The upon analysis response rather has said, rate of first progression-free a will objective and earlier year February. in designed in patients it’s as So the with the that the

for And progression-free endpoint this half, response of randomized the so In we’re second survival endpoint looking conduct to analysis objective all is patients. second and co-primary the the rate. amongst

P.J. So over the I’ll design, and hand trial to that’s basic

P.J. Haley

per who – metastatic at previously looks what number said, about there’s to or patients, received This therapy had think, I I’d over obviously RAI-refractory a add of patients, XX,XXX differentiated cancer systemic TKI. as year quite Yes. I’ll thyroid trial is a Gisela Hi, a in that Michael. just the U.S.

is really population, taking the I’d account that data into So no setting. randomized for agent say, approved that importantly, part what there’s of or though,

So and to that progressed those help And utilize of certainly a sort a in longer draw to historical a an And the it are on to who’ve area thyroid an on bit for on to therapy. therapy in well. company prior patients as has as experience opportunity also malignancy patients. cancer that little opportunity tends really be patients help Exelixis

So that frame I way. it would

Michael Schmidt

just study to behind maybe tumor cohorts, I mechanism the data be then included to this what in choice hypothesis clinical mechanistic those, guess, to more the the And And data of should a types presentation? or the coming Phase of expansion XLXXX. out based expectations with the of selection XLXXX, on upcoming that be related I here is talk about great. on respect the Okay, maybe of

Mike Morrissey

with don’t Peter then we first answer Why question and after. Yes. that Gisela

Peter Lamb

major abstract Yes, this is meeting. upcoming said, as to have With we Yes. a Peter. respect to submitted I publication, medical an

year. the foreshadow later going and in data I really to exactly update XLXXX looking providing want to don’t we’re on that’s what substantial an be. So to forward

acceptances, we’ll happen. when of haven’t the we We details and point. where presentation at be will But finalized as happy abstract to the this provide presentation get

Michael Schmidt

Okay.

Gisela Schwab

sorry. am I

Michael Schmidt

No, I am sorry, Gisela. go ahead,

Gisela Schwab

on of couple words development just clinical And approach. the Okay. a

inhibitors the a cohorts a are a certainly as Of course, being progress phase, And we opportunities, instance and upon body these large a of of also different making But yielded forward which course, our as indications. we to in to combination XLXXX. have of emerging experience but we XLXXX expansion with dose approaches intend are next-generation program, also – the apply XX beginning, various and based study learnings we’ve at the evaluation, from IST learned with checkpoint and cabozantinib looking the cabozantinib CTEP lot for in first looking interesting such the data information. family broad the and at course, escalation MET and lot development inhibitor, and of in the in has with kinase XXX single-agent looking, TAM its program, cohorts VEGFR

to forward forward here looking updates more moving providing certainly forward XLXXX development. So late-stage looking rapidly into and to

Michael Schmidt

if then thanks. last, one may. I Okay, And

mentioning this interest if think I was new lines or in if P.J. more you about technology? actually platforms. partnership of along maybe you’re clarify could a collaboration some And or we lines? platform comments around just heard I thinking R&D those technology something help along new about think the I make acquiring should if wondering development Or business

Mike Morrissey

that distinguished Michael, accent. his with was Peter very Yes.

that So question. him upon go opine I’ll let Peter, further ahead.

Peter Lamb

Yes, was Yes, section. it this is Peter. my in

been mean, what we look, I internally. that for we’ve technologies complement So will looking do

library. think what compound I we internally do got very the do big well. we We’ve

high chemistry. a medicinal in We’ve obviously background running We’re screening again. deep throughput got

target were interrogate to modalities. there broaden out able therapeutic that landscape technologies really range broad we’re the and and of differentiated But So there targets. provide reasonably approaches a

Iconic from why our IND factor hopefully, looking targeting TX will ADC, that’s of view, think we’re BD a be of the partnering point in first partnership, both at biologics various extensively year. later kinds, the I biologics very

look to that might or than and house. be or partnership assets technologies continuing in that best it collaboration being brought done individual can be either we’re So in broadly can rather be

case-by-case much very way in So will is obviously, which transpire the things basis. a those

Michael Schmidt

Okay, great. Thanks for clarifying.

Operator

Thank you.

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

line Your now is open.

Andy Hsieh

everybody hope Exelixis. staying thanks. well at of activity doing my in in checkpoint interpretation in Interested healthy in Great, experience taking patients and Thanks questions for terms pembro/lenvatinib your RCC. is and

ASCO. I at response over rate it XX% think showed

help in III us Roche that study you Phase similar just context, think, I in especially, put CONTACT-XX the maybe So very patient a and started population.

Mike Morrissey

with lots and Yes, interpret arm, a cabo XX% Andy, IO. single-agent a post question. showing study give based to range I’ll perspective. XX% in even it’s numerous the to by the itself – isolation. upon of in data that rate always for from Any There’s you single challenging ISTs different Thanks some try Mike. cabo combination response bit has non-randomized second-line is populations

– So now it’s data. interesting the second-line of board certainly right challenging a lots setting. in out There’s data interesting there across the

in to we a and cabo, randomized with do? arm itself? you versus randomized the made that study agent have Roche CONTACT-XX, control have at cabo/atezo You setting, think of relative is experiment single allows a to that the looking a that I right does. commitment do. contribution by think retreatment that’s the components study get of understand to the good clear So very really of IO versus TKI we TKI the a picture does a the what to right top with What combination on and on

up and be that, We’re now, to hopefully, on there with enroll working and that’s we’ll and running Roche obviously, fast.

Andy Hsieh

is study you’re histology And the of unique just that enrolling. that one cell to the think, of follow-up, I factors non-clear

if the sunitinib a guidelines, look is So recommended as you only option. probably of lot at

clear help us about to of that cell the potentially expand non patient, strategy kind histology. by the think going just enrolling into forward So

Mike Morrissey

to to Gisela that Gisela? one to That’s going upon. over question I’m put great opine a

Gisela Schwab

you Absolutely for the thank question.

and non including clear atezo non carcinoma combination of of yes, patients We've, presentations this and course, in CONTACT-XX of clear data study. study. cell to forward information the cell was ESMO population of both in collected patient dedicated and the looking at cell a So this patients and this cabo in cohort

patient study. exclude influenced bit little So certainly information broader also randomized the this willingness that to and population a

looking data trial. to So the certainly forward from

Andy Hsieh

the XXX. is And Okay. right XXX for company be Thanks so that insight. and Peter, for one TKIs may advancing two

focus MET in So profile, being the more and differences beyond just focus. target probably one TAM

the in advancing us TKIs help in strategic parallel? of terms understand two Just positioning

Peter Lamb

wealth So preclinically compound, probably single the to, data Andy, sets both cabozantinib, experience agent and as obviously, will encouraging of and that increasingly expanding our and clinically this with goes combination IO. a very both for think, back, in with and I

felt as of ideas that how of and a it of about those. met less will thoughts met is XLXXX cabo, we VEGF. to later or year. VEGF, focused, the is data more XXX much lot number the investigate change a is compound we discussed, well might had variance XX-K more and the profile. to we significantly generation we've on sense tweak so and in ex that So published less first made of go back be It

preclinical want I that. the emerge, that those it's productive drive, large in to the a But where how go things area such for – So that would we'll covered make will extent have data we and clinically. a say, – been it's sure ground see such and there. interesting of We

may come. in to We're working still so see. the more So variance be there area, we'll

Andy Hsieh

congratulations for progress. questions to absolutely. Thanks It’s presentation forward and for nice. all Look thing. the answering perspective. sharing Okay, interesting Cool. on the an the Thanks XER that

Gisela Schwab

Thank you. Great, Andy.

Operator

you. Thank

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

Your line is now open

Kennen MacKay

is has and that thank bladder change. to Hey changed my dramatically is on a taking continuing treatment This for questions. cancer, one Quick landscape

plus of a otherwise at checkpoint potentially your in COSMIC Just looking form on some shape a whether wanted cohort, it’s to cabo cabo part or or get way, [indiscernible] perspective combining

Mike Morrissey

go Gisela Yes please. ahead

Gisela Schwab

really Sure. certainly monitoring new And new Well, overtime. and being in evolving field as introduced treatment and we’re landscape certainly with is closely. bladder opportunities shifting very, stated, compounds very cancer an you strategies that

activity with seen We're at have previously cancer. inhibitors with checkpoint bladder conference and GU recent with has activity experience good ASCO patients We the been treated in presented such seeing cabo. a single-agent

could opportunities combinations but we about play so to certainly could with in the that evaluate with the compounds And And roles XLXXX. that be also important thinking are it be different continue cabo here. And the field. importantly that, with

evaluate and the certainly that on So list forward development. of to potentially in drive is things

Kennen MacKay

so it, Got much. thanks

Operator

you. Thank

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

now is open. line Your

Stephen Willey

the afternoon. good for Thanks questions. Yes taking

the compendia prior commercialize the being a launch-ready, listing by I XER Is guess, in formal getting approval? anticipation to in of regarding Just NCCN August. terms of of end kind to that comments of maybe some

P.J. Haley

Yes, hi P.J. is Stephen this

seen that since XER to as go just approval obviously, comment or an that. ready share do to of lot duration the think of compendia we've I with the first-line important potentially really educate of physicians ready to a drive and launch. opportunity to a work to for beyond possible, to important heck NCCN the really of for bring be incremental that. setting get to I results in been be wouldn't what to because launch-ready well broadly as on it's market that benefit patients soon or ready But doing we CABOMETYX we've pending be speculate as as as us view

So we just to ready go. want to be

Stephen Willey

I data, saw in And the some we hazard when guess the of Okay. deterioration was recent event-driven most KEYNOTE-XXX the there ratios. update

of the you do out presentation the plays meaningful? how guess, XXX? I important or around And think context much that does given data more guess, XER subsequent make of more And much that that, with so initial given, I the potentially almost presentations prescribers, historical that

Mike Morrissey

with combinations, data solid years. been data that's the is might variety want last the there's, few Steve. I in certainly, evolve of different speculate for et Yes, times. I XER cetera, over think, solid to is a Certainly, on – very renal This time, wouldn't at how very all important Mike. looks All magnified area but the over follow-up data data. trials,

earlier combination a looked of nivo to very population. needs context cabo in mentioned I potential be Q&A, the the as can benefit across carefully totality in think, I the of at in with that broad data bring patient the

evolve data. is but new continue We'll – look story its we continue to data, look to and data data at evolves. data and So the get the as

Stephen Willey

next, to be And purposely guys just you value-focused. months All kind the of may preclinical them are agnostic And enter from of guess, a little so. and Or approach of nine think, kind like go to out of a between you some management your you take I over maybe bit need within kind guess, that perspective, clinic gap going and the commercial have bit a you being have? you mid-tier follow-up the care portfolio of you more that, have ready space side, or then a to stable a all that I drugs development of shop of a of of assets, kind and earlier fill of themselves? kind the the care feel number will little characterized do BD maybe that And now right. bit do preclinicals lastly kind to feel on I the of be that kind just

Mike Morrissey

So we're cabo work, of certainly at, data, existing comes I lot differentiating the with a seen to we've looking question potential ours been doing a commercial And while. the very say, data in That's interested to focus drive always opportunities right the upsized clinically can assets would past. that clinical-stage now. in data, as for of down generate a

that indications. how So both and data clear indications for at opportunities at currently lens and of we we're look a those that outside look very we are have clinical to within want pursuing

together way over maybe that integration approaches the say we're those got binning of to a complete worked very vertical talking that the most So internal we're the we think, and be Peter clinical hard of portfolio we'll to large done? that said I our And assets both What In platform, themes and done? the years. kind investigating, terms these last of looking so there's few and we've got, molecules appropriately. in importantly about we've kind as of once that we've preclinical the the we've currently more we at transactions, indications certainly why build eloquently,

here, to tuned. a want it I'm stay the a don't effort that lot fruition to big, I hoping big of short-term. now, to come and except that right got Obviously, in So, say say we've will specifics

Stephen Willey

for taking questions. Great. the Thanks

Mike Morrissey

Yes.

Susan Hubbard

Okay. Thanks, Steve.

Operator

you. Thank

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

open. now Your line is

George Farmer

reported ovarian Genetics bit thanks cancer Alzheimer's iconic comment do Hi, go some your data shortly? Are thinking or positive that into with to about its taking picking the little indication? on has clinic Could for targeting going ADC the you population cancer, with you be prior tissue cervical and infector Seattle ADC agent. you question. a an factor we'll with

Mike Morrissey

George. Thanks that to one? want take Yes. Peter,

Peter Lamb

Yes.

– data, in this the our on is file obviously, speculate agent targeting is iconic us again, data, factor to or tissue it some we're of at later year, that for that at there But right? the to version could preclinical information. So, have we track, provided. proof-of-concept when be was I compelling And differentiation mean clinical ADCs. this be me let you're to point. what discuss year. know. this premature of The might a you correct, still yes, and currently This this on clinical anticipate IND We'll for strategy because we certainly presenting meeting It

come fruition. will that hopefully, to So

George Farmer

year, Okay. does to cabo, Great. assumptions? you your include revenue on your on if so, of do that and of your use moving And some following kind this XER can assumptions, guidance results us walk through

Chris Senner

Yes. Chris. George, this is

net the not year. product XER to does in of So XER, include guidance our of $XXX revenue for million assumption revenue $XXX the an million current

George Farmer

Okay. Very much. good. very All thanks right,

Susan Hubbard

Genige. you, Thank Okay.

Operator

you. Thank

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

is open. line now Your

Paul Choi

for Good questions. Two you. for taking ones quick our everyone, Thank me. afternoon, and thanks

First, patients. squamous CONTACT-XX trial, on inclusion/exclusion non-squamous criteria the between doesn't the and

on maybe maybe volunteers. are Thank understand Or Peter plus that Can And a the us non-squamous then what you initially in can the XLXXX it healthy second, you combinations separately analysis treat checkpoint you. primarily just basket? elaborate Or include Will there? slides. in between are be testing targeting you'll sort on of that mentioned inhibitor then decision an be and help describing you to And you analysis patients going assume squamous population? of the So squamous? does the statistical populations? the to that entire

Mike Morrissey

want please. Thank handle you, Paul. those Gisela, you questions, to

Gisela Schwab

thank you. too, Happy Yes.

cancer. non-small lung question first CONTACT-XX pretreated inhibitor So your checkpoint regarding and cell

Of there's an cell squamous need non-squamous and both for unmet course, medical histologies.

and And we by decided course, both to in technologies, have we so involve RDT the go by have itself seen histology. copaxacone information both forward and study to itself in both back dating of consist for data, ourselves, for activity the atezolizumab histologies also,

a patients. the conclusion around both to checkpoint The outcomes reason the similar of see assumptions to in are these to came didn't both so strategies. – were inhibitor we we protocol include So various both trials. There exclude integrated, course, that and

analyses in stratification are histologies to and analysis, be going these the regarding of trial integrated on. the about So course, thinks subset as one so and

plan study. I'm it sorry, forward of the your going as it. is Go with now. I that's the and So second note And forgot question, I a haven't taken ahead.

Paul Choi

in for you you. just are regard combinations, – plus of testing inhibitor with patients Sure. sort checkpoint to you the what volunteers? testing Or not, if It's referencing were of XLXXX initially the considering combination? Thank the healthy

Gisela Schwab

Sure.

is this plan evaluate histology that really CRPC to dose we So in malignancies. appropriate specific combination more or with to healthy cancer patients patients will including expand and expansion The are RCC in And the with other looking cohorts volunteers. the then into and types. so test are be not advanced

So certainly we development cabozantinib building our the have on gathered in experience program. that

Paul Choi

you. Thank

Susan Hubbard

Sure, Paul. Thank you.

Operator

Thank you. [Operator Instructions] of Hung the line Jeff Morgan Our next question Stanley. from from comes

open. now is line Your

Jeff Hung

my Hey, question. taking Two for quick actually. ones thanks

on provide Have levels? starts. to on where returned I are relative you Can patient more pre-COVID clarify color then year? the And a in have stable follow-up. to those you to new earlier Just

P.J. Haley

of on did that with And I a regard as Oh, of disease areas, for a that question. say sort to standard the basket similar seeing other of nater to yes. market June. for we'd is well and the Thanks that, P.J. May. think as the what Jeff Yes, see, to we in in in quarters sort starts bit then a whole drop-off we've recover new been level patient It’s

sort kind it the system into more of So we've was generally to May. during seen to patient eight-week thought by March in really and, access period six stabilize of I care stressed that that driven early late really being mentioned, as health

Jeff Hung

events year-end and expected? enrollment you. Or COVID? believe data XXXX. early too half expected by first from Thank the I XXX more then now Okay. Thanks. were impact that think to it's than Is taking And previously, from it are change this is longer

Mike Morrissey

Yes, Gisela, ahead, please? go

Gisela Schwab

of was April, call, impact in impact the pleased in and And very as Sure. question. we've the has saw modest really some early on the Well, we quickly and completed in stated for March global earlier the screening reversed. has COVID you more and the and now on patient progress very year we're was the thanks that enrollment, enrollment study where with

events survival with enabling bit interim and are would would we're complete the seeing endpoints, us closely, XXXX. study. And said in so that overall for And And now as a for both of very us analysis, in for or early final that, analysis the the PFS the a to very earlier, slower first than to end the as top And the course. are of are I achieve And tracking them current XXXX tracking both for towards little enrollment events, these we expecting we important global that come event in we're half of XXXX. projections first line lead we the anticipated. data now,

estimates. so And have very providing looking little forward events accumulate a more part. to just certainly granularity situation step that is CheckMate we a more that more really as while as a precise and similar through the followed XER analyses similar And back, we have

Jeff Hung

Thanks for clarifying.

Operator

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

turn call over I Susan the Hubbard. to will today's host, so And Ms. Hubbard?

Susan Hubbard

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

Operator

this for Thank today’s gentlemen call. participating. and Ladies conference concludes you

may You disconnect. now

Exelixis (EXEL) 7 Aug 202020 Q2 Earnings call transcript