Exelixis (EXEL) 31 Oct 192019 Q3 Earnings call transcript

Company Profile

Participants

Susan Hubbard	Executive Vice President, Public Affairs and IR
Mike Morrissey	President and CEO
Chris Senner	Chief Financial Officer
P.J. Haley	Senior Vice President, Commercial
Gisela Schwab	Chief Medical Officer
Peter Lamb	Chief Scientific Officer
Andy Hsieh	William Blair
Michael Schmidt	Guggenheim
Silvan Tuerkcan	Oppenheimer
Kennen MacKay	RBC Capital Markets
Yaron Werber	Cowen
Stephen Willey	Stifel
Paul Choi	Goldman Sachs
George Farmer	BMO Capital Markets
Jeff Hung	Morgan Stanley

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen. And welcome to the Exelixis’ Third Quarter 2019 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. President Affairs Vice Investor Executive Hubbard, of and Public Relations. Susan proceed. Please

Susan Hubbard

Gigi. Thank Exelixis’ all for third thank joining you XXXX you, results And financial us call. conference quarter for the

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

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

development, strategic course presentation, or differ about future of commercial, could, we regarding making statements future forward-looking the discovery, and materially. and events of events company. this the regarding product developments This financial includes the of possible matters. will statements Actual be During course, regulatory, results performance

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

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

Mike Morrissey

today. call on development business. maintained the strong diversify quarter everyone our external We and thanks internal across new pipeline Exelixis XXXX for significant from third joining with progress we Thank cabozantinib sources. agents with our the right. to as you, Susan. of And our important program strengthened had expedite momentum All and us a components oncology franchise, CABOMETYX all

I providing of and important review of XXXX over then a will business. by to begin third Gisela to our today quarter summary the P.J. our brief turn and milestones Chris, call components

performance million. revenue Key today’s highlights include, for in third for was to franchise first, of Total is the quarter Net $XXX financial cabozantinib deliver approximately million. Exelixis $XXX approximately call was continued XXXX. revenue strong the quarter

income $X.XX Third was and non-GAAP quarter non-GAAP net diluted approximately share. were $XXX million per earnings

net Importantly, $X exceeded first time, over franchise four global consecutive the for revenue quarters. cabozantinib billion

has growing begun ICI inhibitors don’t which generates dominate first-line steadily have been carcinoma, setting, immune CheckMate study We the competitive sell combinations TKI last XER as or cabozantinib over checkpoint well quarters, bodes for data. several market the the to if

progression to the This was Cabozantinib product free net the to approximate combos of survival five-month to result flat in patients revenue first-line four-month progressing from first the due from to ICI of delay transition ICI a sorafenib. second-line. extension for first-line quarter-over-quarter compared TKI essentially

will first-line you any ICI on combination be CABOMETYX patients for the progressing As TKI of continues choice hear, regimen. to

efforts continue to cabozantinib to pursue and we development aggressively regulatory Second, expand franchise. the

anticipate cancer. cell trials pivotal cancer with critical doublet, the lung and XER cabo starting advancing cabozantinib and CheckMate additional from We emerging data, COSMIC-XXX potential and studies pivotal nivo trial first-line including for are non-small in the for quickly trials, including ongoing prostate RCC

from sharing We expect to key start of trials in these some XXXX. data

survival survival in to recent and improve free In both addition, the we atezolizumab, are progression doublet encouraged by of HCC. success first-line overall the bevacizumab

first-line investigating the HCC indication efficacy setting. and This support once combination in data. were compelling result second-line ICI role in a the for and ICI provides moves HCC containing generated additional regimen highlights has for this third into an also first-line potential COSMIC-XXX, expanded A atezo combination CABOMETYX anti-angiogenic cabo

all and other related and product While these the to internally a sourced externally highest team assets oncology build XLXXX cabozantinib advancing activities diversified with priority, is pipeline. our are proceeding

our seeking the Third, our limited last we property Based that CABOMETYX for FDA month of certification other expires received October responded patent filer has matter the enforce X, and we relief primal among XX, and after have not filing lawsuits, composition our notice the on challenged we Through received which lawsuit expiration have may paragraph approve are yesterday to filer not ANDA a from by August ANDA on our patent, of ANDA on XXXX. until a to-date, rights. XXXX. the order we intellectual information this

progress all both QX time and company’s XXXX a the performance Our dynamic our across of business very RCC indications. components during throughout highlights HCC for

of revenues, strategic grow to the Our long-term overall growth. diversified goals expenses a to build We remain manage capable reinvest seek free same. sustainable business and cash carefully

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

Chris Senner

Thanks, Mike.

Total of Genentech. For $XXX.X revenues quarter total million. revenues partners revenues $XXX.X the million. company reported included Total the company’s the commercial collaboration also Ipsen, the collaboration included Takeda cabozantinib from million quarter of third net for $XX.X revenues of recognition the and in product revenues

of for million included quarters. $XXX third territories their Ipsen revenues recognition from the Collaboration consecutive of of sales collaboration quarter the with of milestone fiscal a cabozantinib $XX million net over achievement a in four our for

cabozantinib Ipsen milestone XXXX. the the to Collaboration receiving sales approximately anticipate million payment cash royalties $XX.X XXXX. related the also includes quarter in by for million from in quarter revenues this of earned of third fourth We $XX of

million, quarter significantly operating agreement to primary in expenses the the expense XXXX quarter compared by third third million Aurigene in of second million was $XXX.X by during operating the of $XX.X XXXX. and we the the R&D signed increased for the were expenses, increase were $XXX.X impacted driver which license of total with Our total quarter.

programs an made options Exelixis from upfront has agreement, million Aurigene. payment the preexisting of of licensed terms for exclusive three $XX the Under to

three Aurigene Exelixis discovery led upon selected totaling additional mutually and additional and Aurigene targets for agreed exchange program $X.X addition, option payments In million.

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

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

and billion at September approximately long-term $XXX approximately compared Cash $X.XX and XX, investments totaled cash equivalent, XXXX, million short- XXXX. at and cash XX, and long-term investments restricted to December

Cost The Now turning of financial financial to guidance. be X% goods our is sold to X% guidance expected is of net and for updating XXXX. between its product company revenues.

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

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

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

P.J. Haley

is by the in launches the number RCC, in quarter in of CABOMETYX XXXX. to XX% be XXXX. X% am the I Thank in relative you, for one to demand continues first-line the inhibitor XXXX immune or Chris. review context which the CABOMETYX XXXX to third of notable declined quarter recent commercial of TKI QX to third three performance ICI prescribed pleased checkpoint of QX by relative XXXX and combinations. grew QX in CABOMETYX

quarter. QX by to in and XXXX The and X% increase QX by XXXX prescriber relative XXXX the grew base prior of XX% CABOMETYX in QX continued to to grew relative

be continues broadly the used risk and settings, lines groups community academic therapy. and RCC CABOMETYX to clinical across in of

axitinib axitinib nivolumab both launched first-line QX were market The combinations very avelumab joining as RCC and remains TKI combination and as ICI first-line ICI ipilimumab, dynamic options. in of pembrolizumab

new the resulting market data ICI IQVIA combinations share in TKI decline data dominate the approvals. by RCC expected, class new now brand impact monotherapy the that driven first-line shows and patient as

RCC TRx prescribed declined X%. data. for CABOMETYX as volume to the the monotherapies. late TKI after and TRx pem/axi be in the Acuvia then in on number CABOMETYX declined QX, based well stabilized XX% other launch, volume continues one relative and in CABOMETYX XXXX to the and TKI by QX performed market and QX RCC over share was up expected Year-over-year prescription QX first-line

And importantly, market adoption volume X% and share grew two ICI total the of is in by worth the overall growing TKI each expanding, that of demonstrating year-over-year. for overall setting. is It sequentially X% combinations, by RCC noting in TKI community this last market. that the driven grew maintained Furthermore, market CABOMETYX market the this TKI competitive the quarters, market in TKI particularly

patients quarter patients continues according impact. on for who of who dynamics therapy, increased it XXXX. Moving NivoIpi share or to is to first-line as the CABOMETYX majority on capture treatment continues of the CABOMETYX third Also, combination to second-line be onto choice in whether ICI of new RCC, NivoIpi patient the well-positioned pembro/axi. progressed brand CABOMETYX progress therapy market the

of number continue patients steady have to treated second-line dynamics an second-line as reach have been setting to state. first-line and combination market in this we expect the ICI in increasing previously with yet transition An first-line the to

while TKI the second-line entering to decreases the of continue happens, progressors. second-line percentage as utilization increase, an second-line increasing this the As market should are monotherapy per ICI transition of patients ICI

fact ICI label we second-line setting to believe largely in per the to which continues point to in population. the the second-line only benefit remaining is agent a that with the it’s the TKI strong CABOMETYX research the due Market of any choice after combination, OS

Last the demonstrating the HCC to survival bevacizumab a Roche week, study survival. positive of Turning to Serafenib combination progression HCC market and in overall Genentech in announced and atezolizumab first-line superiority both for free dynamics.

negative setting. reach evaluating marks therapy inhibitor context This that market. in announcement and the of an tumor against of result study in immune notable checkpoint single type anti-angiogenic the third a may CheckMate an XXX doublet agent Serafenib combination same nivolumab recent that the This the is

potential Cabo with will first-line that ICI in approved We the that would therapy think over range wide ICI bevacizumab about HCC a combination we in front-line. get turn indications. atezolizumab for should second-line in of evolve combination of monotherapy encouraging similar a ICI TKI fashion the the market setting time. landscape as decrease find the the of across to the increase in This utilization in to second-line Should as and of move potential monotherapy the in RCC future will HCC, is of this likely

The setting, second-line if in data trial effective HCC treatment the Phase paradigm CELESTIAL first-line broad ICI first-line more pivotal for growing well X population demonstrated survival ultimately market in into therapy CABOMETYX potentially overall the and with moves from the positions therapies. changing our second-line growth a and

potential other indications. RCC in this and that TKI as We could we cabozantinib currently more expands strongly in progressive. CABOMETYX approved forward RCC, HCC benefit momentum CABOMETYX one and building and it’s remains many and prescribed look number indications on patients eligible from believe to the program development the

Future inhibitors. with maybe and our trials Cabo in evaluating and outcome immune of HCC the growth checkpoint for RCC, beyond, driven combination by Cabo

CheckMate is XXXX. ICI of phase read three studies, Cabo combination first which the early is in these expected out XER to

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

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

Gisela Schwab

and with Thank provide happy the to ICI, update I or ongoing a four current will includes agent in regulatory progress I studies. P.J. single as quarter. in am you a program combination for development with our Phase X Cabozantinib brief which on start our

this The is study and are results in first-line XXXX. forward Phase XER, nivolumab advised in and X to completed with trial RCC groups. reported, earlier Sunitinib First comparing cabozantinib all in has early previously enrollment we looking most risk year CheckMate

results We expeditious the if enable warranted to the available regulatory who data. team, are executing BMS by filings future the our and are partners development are preparing currently topline study with once clinical

COSMIC-XXX, last globally. pivotal enrolling Phase making excellent XXX actively that progress during X or additional initiated XXX and so we Three nine months studies, are and are the patients

three these X inhibitor. single study was Phase a previously reminder, DTC include refractory received studies agent in COSMIC-XXX, placebo a As VEGFR controlled radioiodine

or triplet nivolumab ipilimumab. is and cabozantinib nivolumab COSMIC-XXX first-line sorafenib approved in the a X plus and poor of first in Phase comparator. intermediate of risk combination HCC. the X for patients RCC our to the ipilimumab And trial COSMIC-XXX, in combination IMDC, trial atezolizumab and as with and of comparing advanced comparing the ipilimumab first-line nivolumab Phase trial cabozantinib This a evaluating combination the with

at making three development on I the the these further progress updating and So plans are late is stage working look program time. cabozantinib to on concepts forward you and we appropriate these great

tumor seeing indication. cabozantinib In addition, encouraging a has results The different early in of study are COSMIC-XXX been patient XX expansion court and to atezolizumab actively continues and excellent Phase study we occurring make across Ib and progress.

As hormone-sensitive early the expansion cohort objective prior novel one could from course the rate this reminder, received Notably, in patient the therapy in resulted hormonal a and has for key version data stage of objective is have mCRPC response RECIST received cohort. expansion the docetaxel of have in X.X.

oversight cohort. have This the received study also immune prior together recommended chemotherapy inhibitor cohort prior cancer cell expansion our checkpoint inhibitor lung has or patients progressive Additionally, committee failed who and of non-small sequence. checkpoint standard immune in includes and

actively evidence to of evaluate cohorts XX an first early patients enrolled. enrolling additional are among XX patients Both activity further seen the the

Additionally, four total single to cohorts the patients evaluating cabozantinib in number of in we CRPC evaluating study and cohorts study, the cohorts agent new XX combination two the to or cabozantinib this have including indication. and added cohorts of atezolizumab of bringing this two atezolizumab,

atezolizumab the single activity characterize visceral nodes disease. or disease who patient sensitive to aim prior measurable same of NHT extra with or in have one CRPC could prior metastatic cabozantinib cohorts and have two pelvic docetaxel received latter the received hormone lymph for These with population agent

We the mentioned trial, about the III various are are the non-small trials including lung hard and working by if development future CRPC progress the cell excited broader late-stage include cancer on settings in cabozantinib in may Phase while that advancing we indications data. warranted the

On worldwide. a for been the the of me, cabozantinib has lot side progress excuse regulatory regulatory side, there on

weeks Ipsen RCC a partner regulatory and ago. EU regulatory its rest Our approvals to-date Canada has couple continued the recent submissions most XX for in first-line including of in in of cabozantinib and territories countries approval world has obtained

the in Japan Takeda partner And RCC regulatory NDA regulatory progress. completed of cabozantinib an with the their advanced to filing on look we XXXX in Japanese update authority with for of treatment our patients in April and forward

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

Mike Morrissey

the and first-line of with CABOMETYX important patient opportunity We setting in nature setting. segments. and CheckMate in All potential third components dynamic right. of an provides markets quarter for for for context business. of eagerly all first-line moving The the prospects Thanks maintained topline the RCC HCC especially XER of strong upside for Gisela. XXXX individual HCC the await in therapies in Exelixis into RCC across these the momentum our results ICI-based both first-line first-line each

net third from its notable It’s see four cabozantinib to billion growth with time global and strength revenue new future candidates. due and current based ICI R&D in strong significant for more to U.S. third combinations in product in Exelixis cabozantinib performance the Notably, significant quarter we achieved quarters continue in this with potential continue for revenue the $X consecutive business the of as opportunity and over XXXX product momentum a first the CABOMETYX to franchise in ex face the of Ipsen. trials quarter than XXXX. label competition and long-term we compelling With invest remains that

day navigate need medicines therapies. their make on develop our patients I and every you next-generation for as count want and the more at commercialize a as progress. to entire we hard team our spirit to look discover is the thank cancer opportunities for of everyone and to Exelixis who lie better work updating effective We ahead. forward The that focused collaborative we

Thank in your you are now open And interest for call support for happy questions. Exelixis. continued and we the to

Operator

the proceed. Instructions] Your comes from William from line [Operator question Please Hsieh of Blair. first Andy

Andy Hsieh

you Great. thank questions. for Congrats my the on and taking progress

filing can of you the on if educate first a based us late really calculation IP upon that one, litigation first wondering XX-month just in of will the Just XXXX. so occur stay, process, triggers probably the quarter my which on lawsuit

trying for before specifically some example, am And forth XXXX? what that scenarios patent addressing formulation really you in and potential is that expires lawsuits, that bring to understand are I additional the can after even so what or

Mike Morrissey

Mike. Andy, Yeah. it’s

try the weren’t parse me for the to certainly receiving that Let and one letter by you guess I start the on note out is best ANDA. can. we I surprised that

aware have of know, molecules As small been you normal is well a process, most we the of successful part that. this

We XX XX back so. and that months, have prepared on months that or been going for really planning

be been very the as up, to well the thing. very to come and So place these all them focused pieces appropriately address able that’s I first to we that efficiently making sure okay? very in expected have we issues on have So we think

Second that able of a thing and address team have this for externally part to legal is we got to as internally of strong experts be process us.

and data So I team the about and we IP we supports in the feel very good place certainly in degree IP and as the that a have go the we high got confidence the IP both enables of have forward.

the of press I the my do scenes can tactics don’t behind this in the say the to say, legal in we the remarks, really want want effective we they and don’t our, their that what litigation what than as and have we prepared publicly involved I team terms Q said are more enabling In to want be and let in we as doing. thinking strategy, and obviously jobs about to of parties would experts without release litigate we other and

step a go are So that investors this information as look material we we at side first we as we and as milestones other the certainly sell will be with the hit sharing forward. process believe in and that

Andy Hsieh

Okay. Fair enough.

think on the of impact have how that is prevalence in One about of if the these observed. the laid moving higher net than two setting also So out patient my what this longer quarter basically franchise, expanding will. think maybe about components? kind patients CABOMETYX XX% elegantly you the on based holding is I pembro/axi relative is gross P.J. you calculation that kind dynamic we And previously think first-line curious I to of to the

components? us help these of kind two maybe of kind So out parse

Mike Morrissey

Yes.

gross to go to then reframe Chris the transition second-line first-line, we some about Why issues. net to of thanks we the and question. back issues So talk P.J. have talk and the for Chris? about don’t patients will

Chris Senner

Thanks, Mike.

describe mid-XX% talk was We to Chris. Andy, the best about did So, is come XX%. it it’s way we I range. the the expecting guess quarter it year to in out last around are

right around volume quarter segment that’s the during to the required this the what was XX% You also see that discount saying was quarter the utilization are -- also. of the discount and P.J.? we and that XXXB we or increase did XXXB increase in related saw payer that PHS

P.J. Haley

Andy. Hi, Great. second will part question. and Okay. your I It’s the P.J. tackle of

in mentioned, launches really you combinations as is ICI the to lot So, in yeah, observed have pem/axi the first-line of the particular TKIs we driven what by share. recent first-line particularly ICI a the take come setting have of

So the the expected first-line the as meantime in what part and monotherapy share of quarter first-line saw share the TKI in we is CABOMETYX under came stabilizing. pressure latter

therapy Certainly second-line that to combination. first-line months the longer the you to in of is sort coming that in PFS the setting year. transition on as ICI I for of us that results -- acceptance patients early think of that’s really that Mike And community the is both adding does those a four encouraging have as we what the months from about TKI particularly five market XER and to to sort next referred

So it setting. bit the will reach take to a second-line longer

In the the is in continue that that the research these be progressors the will with discussions capture case of indicate all ICI our second-line. majority KOLs the capturing second-line still setting of to and market certainly majority will CABOMETYX the and patients that

for that state is for see steady -- not dynamic CABOMETYX. continued a continues and to potential that as as at be we growth opportunity So see we market that

Andy Hsieh

All Thanks the all color. Really additional for your right. appreciate Great. answers.

Susan Hubbard

you. Thank Andy. Great,

Operator

Thank you.

proceed. comes Guggenheim. of Please from Schmidt next line question Michael from Your the

Charles Zhu

Schmidt. Thanks on guys. Hey, for for Michael Charles is Zhu question. the taking This

to How that the you of trends how backlog to? question to volume think trajectory front-line bit here, sales this on based you steady you in multi-parter about of clinical patients that seeing how HCC second-line? the of think both take become recent and this follow-up referred bit could and for reach are state cabo eventually previous eligible in will should a RCC going in much investors and the forward a do a the a As the the Thank you. cabo of long

Mike Morrissey

guidance market by Charles. I’d it to way what to And forward-looking, frame CABOMETYX. market second-line. of the have stabilize to question, but giving the them seen quarter I dominated has want certainly of for become the as shares things. the any couple for We ICI to combinations, mentioned, last is first-line we guess combination avoid Thanks first-line most sort regards I really a is Yeah. With of have progress that as RCC yet

we that think CABOMETYX potential growth for setting. will So provide in second-line the

want some there. that wouldn’t would take time timing has to predict clear for to that I give market state yet it’s reach which but forward the to and happen the that steady time could to Moving attempt CABOMETYX potential some of

similar dynamic HCC, sort play out. could that a In potentially it’s of

first-line being We the see therapy to now study couple really landscape the and in With forward in that months of that could data a to checkpoint atezo/bev positive immune coming setting. we seeing that could change look inhibitor the moving first-line ways.

of the First are first-line now. standard HCC TKIs all in

therapy care become the So then standard could first-line. ICI of in combination the

the So that sort from first-line bring into of setting more could patients the therapy setting. regional local potentially

And that term over ICI decrease second-line is provide in for well. is the cabo the then positioned market is and will do where HCC performing really potential monotherapy more TKI long well second-line in the what

market potential is said, the in XXX and at and of certainly that forward needs HCC and future built the well. which then market growth cabo as to really as CheckMate first-line for results We grew we HCC for what QX a in will to opportunity study the HCC the look second-line have look both in be always the in we we

Charles Zhu

may need CheckMate in only but to not SUTENT Great. competitive be thoughts in XER clinical the in sense? a Thank are obviously On but are Okay. by commercial there That to the cabo/nivo clinical, obviously there’s you. represented in around order ICIs other report your makes front-line. what bar success What also for sense.

Mike Morrissey

both where KEYNOTE-XXX and knows stands there, that to look get for data competitive everybody point terms not view lot kind We of from the a bar the of question that is, of us where Mike. just appropriate obviously, a survival is like in It’s for might speculate benefits. PFS on out and it’s that what

how we So what to much there, it be, has exactly different see will et cetera.

data would we offerings competitive for much are for rather out right that first-line context that data discuss of in think to the come I be to now available to and the the all able RCC. wait

Charles Zhu

me, see think I new or expansion decision cohorts I this? from the existing I to Understood. to adding a a open tree patients out what thinking coming so I of additional also pivotal few for of behind going versus COSMIC-XXX. Last cohort up for one the wondering am deciding guess kind is an expansion cohorts versus trial

Gisela Schwab

Thank Yeah. questions. for Gisela. you the is This

encouraged quite lung both cohorts obviously cell two early for safety now are cancer setting. has to setting in indications that the cohort from initial on the the observed We in data combination. is CRPC experience intended in ICI better expansion in the sparked by non-small expand the understand This and these further activity and and pretreated really the and COSMIC-XXX the

to to single-agent for by intended that of the is described multiple the the combination plan the are very contribution so I and the do a address cancer address really prostate that receiving to randomization data. the here concurrent and is we The things. components to patients addition cohorts of One, with activity early therapy, encouraged so of

Charles Zhu

for very taking the it? Got Thank you much questions.

Operator

Oppenheimer. proceed. comes Your Please Tuerkcan of next from from Silvan question the line

Silvan Tuerkcan

taking for quarter. and my you Hi. Thank congrats on the questions

Just I down drill just a little to on bit sales. -- the wanted more CABOMETYX

see XX months one increase and four versus that combo the PFS the ICI I to up of months So approved. increase TKI look in I XX at PFS. was if

But maybe in into be enough inhibitors checkpoint thinking So that market the patients more would the, I I reach be quarters tail. to flowing obviously, be one, two in would with correct second-line? of well, equilibrium in would long there’s a correct thinking that the

P.J. Haley

to Silvan hasn’t on steady this of time as the want certainly that, Yeah. think and is to that to their wouldn’t launch RCC that but mentioned to increase what’s CABOMETYX have certainly continue could state of speculate reached clear exactly take market. some a given PFS growing recent P.J. is market I I gives I the that and second-line timing you potential relatively grow pem/axi as in TKI referred the monotherapy and

Silvan Tuerkcan

in BD, have an cash. Great. And you then quite Thank amount of you. your of terms impressive

partnerships. early very have You

-- your, let’s say, You are mid-line COSMIC-XXX. expanding pipeline mid with

You some reading out assets late-stage year. next early have also

filing? anything So focus changed here has the what’s your and ANDA with

Mike Morrissey

Yes. It’s Mike.

So surprise no has And we as over said Andy, the the last ANDA BD calls, filing as to thinking I consistently and we impact. continue have attractive before wasn’t from around big talked and very for pragmatic our I again are be the on that to us to look about commercial question several a think we think had thoughtful clinical potentially a to proceed situation. not able and in if mid fashion assets for late-stage assets and commercial competitive a

continue. a diligence oncology to assets We arguably have space that find competitive effort a if what’s broad search and will in pretty ongoing i.e. and hem/onc you and will

diligent So look we here. very are

we don’t either. sense how deal. go want overpay into We being rush want don’t after that assets are and don’t certainly We us want careful to pragmatic to to very and a proceed. to about make We bad don’t

way we value that sure stewards and that that So we can are of we forward. being good make we upon shareholders’ making moving the maximize appropriate a based investment in think going of any dollars forward is

will more we and setting. So as public progress transactions to investors in do we of some be about that make these a we speak with sure

Silvan Tuerkcan

year Great. next and the quarter looking taking and readouts forward early questions. to thanks Well, congrats for the all on my

Susan Hubbard

bet. you. You Thank

Operator

you. Thank

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

Kennen MacKay

for Thanks question. taking the Hi.

have to maybe had at other disease differences at with median label I proportion deck could we KEYNOTE-XXX as plus on sort me trials that frontline low-risk think note are an XER? trials proportion we so any the it are think thinking speak label the appropriate by XX% of XX% of about trial. CheckMate as about is their trial to it’s Merck? a that OS RCC low-risk sort of for other that that in of CheckMate the part PFS And characteristics in frontline about set XER least Is on same just that in and ultimately wanted and the guess is label I/O numbers the that I/O XER doesn’t pembro patients CheckMate cabo’s looking indication approved? stacked having the cabo if that that highest FDA strikes at XER First and TKI just baseline other axi’s the I/O sure if include make successful is numbers a CheckMate Merck data. would to I that trial the combo include really data

Gisela Schwab

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

baseline outcome. I across compare it’s think very to important trials, you point that really that patient is characteristics a on hit can because and influence and can difficult vary

what question to to current in time sharing next so with to are awaiting on speak year. really the when your we XER, this expect obviously to early of at available expected and so in and So we respect forward data data can’t look that the CheckMate course

In I and inclusion of of by labels, to regulatory obviously question and go. so regulatory in data far submission pursue that can indications company terms labeling driven of the it’s and your that as that’s as intent the

I think I partner very preparing collaboratively indicated comes. for development findings BMS the that when time we are and such our working with clinical

Kennen MacKay

you. Got

where is TKIs? ahead and RCC had of you And the cabo from medical Is for I question that still the Thanks shares, you If is perspective? and Thank in a combo? -- in or and only education opportunity other the holding Okay. do those muscling share it in charts out cabo/nivo again. marketing how growth do shown maybe SUTENT of for follow-up Chris, a you. the TKI VOTRIENT graphs market you

P.J. Haley

is that P.J. will address I This Yeah. question.

by all, volume parse of so the showing for data charts are indications so of to all some segments. that it’s the are certainly SUTENT prescription of out there, difficult kind VOTRIENT we and those for indications, other first So,

VOTRIENT see clinical CABOMETYX data. to risk can and really across That performing you well relative competing and other those SUTENT from said, with TKIs we the them see as groups well

particularly view certainly patient them continuing every we as with And for the to RCC a appropriate setting may for eligible that setting. first-line second-line and to not for in and compete priority an ICI experienced the addition in first-line patients the in combo reason setting in high competing ICI be for some

Operator

you. Thank

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

Yaron Werber

Great. thanks taking Thanks team and questions. our for

have last since or on and of couple give possible language have what us think if question I in well. given in us quarters first growth bit a terms some little you quarter-over-quarter know of So launch, you I sense maybe you follow-ons the I if don’t seeing of then maybe just a can in as that two are the of a HCC, sort

P.J. Haley

Yeah. Yaron. This is P.J. Hi,

pleased business is us about. So continued similar to HCC the our first are couple very are to which regards with. very pleased of talked in seeing our grow of HCC we for terms are QX with we the since in in proportion HCC we quarters really performance have to with of in January. the we What And launch

market forward that I to setting. atezo/bev we think as come as first-line be and look view potentially HCC as more potentially we a with better built approved therapies the will more market in getting

CABOMETYX where opportunity where could there. in data the of more to I moves then bring funnel mentioned the well second-line TKIs first-line from generally to and survival transition those the an for that As therapy patients kind our have patients performing into advantage getting certainly and second-line overall as really is confident we therapy more systemic and really ICI

Yaron Werber

Okay.

bringing then don’t letting setting it’s second-line then the mentioned to of cabo vacating then is question to call of want that dominate sort a your it but quite funnel growth ICIs into patients terms fair moving it as of more of market vision? of sort first-line that sort in you and I the is and So in really

P.J. Haley

in ICI to potential the market second-line as Well, the monotherapy. I think, certainly the is there relatively approximately happen is the in currently near-term that for half

So that in trials the us for setting cabo/atezo nice before as near-term second-line gives other in readout first-line. that the would study like opportunity in a the grows certainly relatively potential

Yaron Werber

Okay.

So…

Mike Morrissey

Mike. Yaron, -- think it’s I

from in could of progression way comes a are about see standpoint setting. of previously the then combo do first-line about this certainly and case it could logically at the and the very terms first-line in excited in talked XXX you to how that we look I what as the think more the ICI that’s we Again now second-line relative there term. as to short capturing

is big area liver of So growth a potentially.

last comes that time continue be as more and couple hopefully, data over We goes the of that will out. case on extensively talked have about the to years, and as

Yaron Werber

cabo sort is it And market of second-line so drugs? cabo or really far expanded has HCC the from -- so been other gains share is

P.J. Haley

Yeah.

seen with taking -- there. as well have is not really expansion seen and TKIs really from in TKIs setting is we second-line I think but market the what competing the we the have cabo particularly really yet other of share

Yaron Werber

does in increase seem typical maybe Thank And it long Great. it January Okay. just lot a also benefit of of us and us didn’t a any in X.X%, a you to see a the couple, sense are QX? sense inventories because then terms housekeeping can take the it in that you. was give just the of sense you where price sort have got actually like how give

Chris Senner

it’s Yaron, Chris. Yeah.

will take two pieces. So guess that I I in

had price and QX a the decline up demand an ended is X as QX. then was all basically I during to gross difference price we quarter, to decline earlier inventory the basically it took inventory versus a -- net only with what perspective QX came offset increase is And the from and essentially talked QX. we that P.J. through question. Andy’s So happened we flat July we took the increase talked on about on The during and flat essentially wholesale our then about that the demand in quarter revenue X.X%

Yaron Werber

Appreciate it. Okay. Great. Thank you so much.

Susan Hubbard

Sure. Yeah.

Operator

Thank you.

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

Stephen Willey

just and suggest of for suggest sales. out some you respect you otherwise? and with think because would the diligence afternoon if market and renal regarding yesterday was really I a guess of Yeah. kind And Good curious here lenvatinib to the our was I a questions. in the questions gotten anything But in as curious Maybe share lenvatinib commentary most called that time. if thanks renal of was curious P.J. seen Merck I have of hasn’t But would taking everolimus that the know much couple dynamics. kind appreciate lenvatinib of for driver market anything for cancer, seeing just are

P.J. Haley

Yeah.

is of question. getting the that speak particularly CABOMETYX. hear not after in given len/eve couple it’s to used think for the did Really -- with issues midyear you see I et off salvage saw really approved label. physicians it toxicity get the and as combo just ground What the thanks a think CABOMETYX from seeing the our I we suggested months primarily cetera and setting so really with we and really compete KOLs never

Stephen Willey

Understood. marketplace retreatment of seeing retreatment And not I on second-line? know a that in there I/O that ESMO kind you was kind your curious and I/O some are headwind to or of at just potential to and lenvatinib as as the data perspective whether of suggestive presented

P.J. Haley

this certainly mean, there’s I presented of for with Yeah. some rationale there at data randomized been I that suggest think, not doing no a small data so any but would variety retreatment to I/O are point. There’s sets we really be seeing that.

it’s no are not something So seeing. we

Stephen Willey

marketplace also just atezo/Avastin Okay. guys collaborative then with HCC, set being anticipate Roche how guys kind to curious of with a being terms in I with the from does of well and active up kind do you commercial perspective lastly how then that And you as respect XXX guess win presuming their in just of there you in with atezo/cabo? and

Mike Morrissey

of enrolling. great Yeah. absence including any and the speculate to data XXX tough still it’s data is That’s a on question. that Steve, the in IMbrave It’s Mike.

how could upon both there’s et different the based imagine looked and upon activity based So levers in differences cetera. the pulling there data many tolerability and one

out, once data. different hearing wise we will what is components IMbrave for we probably have again the kind So question we see if the future the of we that come are table that

the will in month next so. that We or sometime see

be So able forward and of the and quickly as then XXX and in that a obviously there’s aggressively stake possible. as being interest ground first that will in to push lots

whether more first-line that’s and following with up opportunity could for So growing utilization a and opportunity we positive with second excited with data growing about that liver. for then set XXX if getting it very are second-line us. us We and think a growth be exciting a would be

Stephen Willey

Great. Thanks the quarter. for the color and rest of

Susan Hubbard

Steve. Thanks,

Operator

you. Thank

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

Paul Choi

our wondering what maybe patients who have duration can appreciate on how utilization to you are immunocheckpoint on a if for CABOMETYX we with and that been you potentially you the evolving. Good potentially afternoon prior the in could and maybe transition questions. therapy, can the seeing still dig taking ICI But little the regard thank the more been duration affecting -- maybe seen that’s how of second-line comment therapy of that’s affecting Great. comment process and you is and on second-line? first-line in between was and the I for I

P.J. Haley

address P.J. Paul, Yeah. is this Happy to that.

really have as second-line time setting. of this an patients the seen that patients combination majority patients in done have over which we So ICI who I the have is cabo we progressed point seen that what as in nivo/ipi think the off at the have capture

really setting fully. of to as speculate the really As in need something to too and seem in been it’s you setting There’s of that too TKIs kind far of duration I for the lots to reasonable lot activity goes all presented that understand sets time think early is that small but a data data early to and get there. certainly numbers

Paul Choi

strategic is decision-making in for Okay. which in regard terms the will then you which timing and of with guess cohorts pursue you and with cohorts ones Thanks to have with to and expansion or thinking COSMIC-XXX, one what will here? the Gisela, And you a lot P.J. I And prune of or priority line any next? cohorts win to potentially which time prioritizing sort regards advance

Gisela Schwab

safety. and It’s now different and committee of Yeah. data types first the activity the expand certain we patients a decision vary oversight much XX the progress cohorts, observed settings large steady process different with decisions cohorts data course with a being study both expansion with cohort too make to XX tumor making dynamic different and upon warranted right and can -- if and the based by

the active multiple in terms those that is so process data very, expand the and to we an have prioritization a ability come study very in see So as ongoing and active together. process we a very of of cohorts

Paul Choi

questions. Okay. for my Thank taking you

Operator

from you. question Instructions] line Markets. BMO of Thank proceed. George from [Operator comes the Farmer Capital next Your Please

George Farmer

wait as have until think to do Hi. complete Do enrolled or question. see we Thanks that reporting over we and all time? my more you a COSMIC-XXX each for data will cohorts on those could do guys bit are comment you think data out and matures? you Gisela, fully taking cohort about how

Gisela Schwab

question. for you the Thank Yeah.

that data I to want can still be We in think cohorts. for mature the said we individual first-line position. that’s and present

have expect mature. we move forward be presenting cohorts we others and doesn’t such mature would as begin data CRPC data XXXX to study including but that perhaps has it that as will in So lung and the the cancer whole we to the

George Farmer

that this you you just second-line? cabo that ICI about second-line saying the confirm delaying could pushing guess, P.J. a or pushing, cabo I into -- more growth? Are are front-line really cabo of And at it therapy cabo the the therapies impact is pushing Okay. has over on those the share again the taking

P.J. Haley

George. Hi, Thanks Yeah. for the question.

-- a take I had setting. think ICI have in the to what come we really and we combinations large a first-line we slide that showed the share

all excuse the and on stabilized all pressure monotherapies then first-line the and the, quarter. put that’s there TKI in declined So the cabo third me, in share

to patients TKI PFS second-line. those then progressing reach sort care or other is previous piece of months the standard of the where first-line And are taking is combinations ICI dynamic. one four that’s of So it than of that longer five longer

ICI really longer combination get those taking where the second-line, for patients an majority who transitioned on therapy. sort it’s into of CABOMETYX is of have and the just first-line second-line capturing from patients So to to progressed

George Farmer

in Okay. there groups are the any And -- RCC? is any various risk in differences there

P.J. Haley

have ones and the Well, see refer in to all that just and of we to take to would the think progress, Obviously, favorable access data. tend risk well. the with sort clinical I to better mean, I groups data we that’s regards the what I to as do longer

George Farmer

Thank you. Okay.

Operator

you. Thank

of the comes proceed. Stanley. line Morgan Please Your from from question Hung next Jeff

Jeff Hung

the taking questions. for Thanks

of talk monotherapy the your you about front-line combo can thinking on in But impacts how IMbraveXXX and second-line ICI for cabo potential about the HCC. HCC talked You COSMIC-XXX? benefits

P.J. Haley

Well, P.J. generally -- I is think, this

better Gisela and have first-line the certainly expand setting with the Mike I think, enrolling. market study we cabo/atezo therapies to and an in it’s opportunity is newer and positive that XXX referred to ICI have obviously, see there combination a encouraging as antiangiogenic an to where study

possibility as forward second-line encouraging XXX moves going first-line certainly think to as in of and bigger HCC getting HCC TKI the out to we the nice setting. have forward reading in ICI monotherapy bigger study opportunity for forward cabo about pie the looking in So and sort of

Jeff Hung

And how new about cabo timing do or for you do year the you in think provide to guidance guidance? on sales sales providing then plan

Mike Morrissey

Yeah. Jeff, question. it’s Mike. Fair

talk stay tuned. about XXXX, will that We in

Jeff Hung

to All right. maintaining Maybe capital with how last allocation do question, one regards about profitability? you think

Mike Morrissey

Yeah.

of talked reasons So thing there previously and tactical as both are several we years. the is that’s business about how and good profitable a part strategic an important over built being why we the last

able the think We as to that’s pretty too. about of part being plan I extensively spend and have talked we more still make more

more We are we get, good driven revenue a profitability, data more business, more data so will and topline continue. that obviously

collaborations, We through have, can to all help internally, so with relative I our think, we we can companies buy assets of to think do how we might we continue through of or the partner can cancer think a equation. patients, big array that part that aspirations through oncology we partnerships, that’s broad diverse pipeline build new what this of for

the forward grow simple a business. formula for be continue it’s spend pretty and to wisely revenue, income, it careful, generate But generate us, going

Jeff Hung

Great. Thanks.

Operator

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

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

Susan Hubbard

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

Operator

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

disconnect. now may You

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.