EXEL - Earnings call transcript Q3 2017

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Third Quarter 2017 Financial Results Conference Call. My name is Brian and I'll 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 Brian the us you third Exelixis financial thank you, joining all for Thank results conference

as me September of Chief development for are as CEO; call developments and corporate, P.J. well our on financial, our Senior Officer; XX, together Joining and Vice the and will our President our President Chief Mike Medical progress Chris who key Officer; quarter and activities. Financial Morrissey, our XXXX commercial Haley, ended Gisela Commercial, Schwab, recent Senner, corporate today's review

soon head finish will out her her you on hear so give remarks. As Gisela has a voice into prepared cold, quite her step I’ll should

the our results our are a with GAAP through complete results we can As be usual, website on press financial reminder, at exelixis.com. accessed release basis reporting a our as only. And

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

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

Mike Morrissey

our all P.J. then and to and finally cobimetinib performance update QX us components cabozantinib Key call turn includes everyone with the for puts activities highlights developments financial second launches million line and significant We head cabozantinib to numerous had thanks XXXX today our Susan, two all commercial potential indications across line Gisela milestones CABOMETYX we the with quarter continued first call of you, first including regulatory for Alright. I’ll toward on operational of Chris, which Thank net for events the of of critical $XXX to financials regulatory today. We XXXX and third million in recent QX brief business. RCC. key for joining of milestones begin productive $XX QX strong over a line new total on and for and the and us and product developments for a performance approximately for additional $XX achieved RCC in the revenue momentum and in our by million XXXX HCC. first, the position revenue for end Ipsen as from franchise summary and activities. cabozantinib approximately with providing

primary CABOSUN ratio a XX, endpoint PFF IRC, X.XX which with RCC. line regulatory date for with favoring trial follows a February PDUFA With Second, priority cabozantinib the and on sunitinib. over progress hazard action ESMO significant we of the based CABOSUN acceptance of XXXX. important milestone made PFS sNDA the investigator and This the first of presentation for review of determined the filing cabozantinib data a confirmed of

Third, the we CELESTIAL global X stage recently at difficulty]. trial [Technical announced

Operator

Ladies and gentlemen, please stand by.

begin your momentarily. will conference Thank you. call conference Once begin please again, by Your momentarily. call will stand

Susan Hubbard

for we apologize I Hi there, cut second. a out got

So, I’ll let Mike continue.

Mike Morrissey

performance line financial and first RCC. I back in Ipsen where those for $XX our XXXX development million approximately with net key for QX of terms $XX go $XXX new of franchise highlights the total revenue our from cabozantinib was regulatory million in I’ll for milestones and to include million approximately revenues product including continued Okay. of first and

made for trial acceptance date we the with February of XX, investigator significant cabozantinib confirm with a on the PDUFA hazard IRC review the of cabozantinib X.XX line follows sNDA XXXX. endpoint the data the based favoring first important and the of filing This and regulatory milestone Second, and priority progress ESMO CABOSUN sunitinib. ratio PFS, of RCC which primary action over PFS determined CABOSUN presentation the of

with to strong and earnings build We carefully. of foundation manage development another operating milestones that while recently time at to endpoint demonstrating with in stage financial we meaningful announced we business in with and as these continuing significant overall placebo the a continued provides a $X.XX in met survival share with cabozantinib diluted statistically Achieving corporate expenses primary of compared growth, commercial posted patients improvement its advanced improving momentum clinically Third, our the important on global strong trial HCC. quarter our X same for CELESTIAL basis profitable per performance. an OS

running generate we and As positive focused flow to to revenues. remain on the milestone discussed business product cash previously, expanding

of the advancing free rebuilding resulting goal cash and reinvesting cabozantinib additional our product into for pipeline. trials the late With stage

to financial. over So, XXXX turn that our with who’ll I'll on Chris? the provide Chris QX details call more

Chris Senner

is net in agreements commercial revenue study. million related last year. uptake Total Ipsen EMEA’s $XX.X revenue. totaling and two in adults. and of includes Takeda RCC by and includes $XX product includes driven $XX.X Genentech. quarter XXX% second revenue revenue acceptance of total milestones share basic of earnings million third advanced diluted per line per Product the authorization later variation the RCC of GAAP CABOMETYX Mike. year-over-year revenue XX% same million with compared the period the revenue of first quarter collaboration also million loss continued advanced increase $XX.X the year-over-year Ipsen, in Total diluted of the for was of and a Total XXXX to also for collaboration $X.XX $XX.X increase marketing This for to our sequentially. the from line US quarter $X.XX was for of The their primarily CABOMETYX GAAP million an to with for for revenue Thanks revenue collaboration the share million treatment $XXX.X from sequential and revenue in

to general Genentech the by costs approach quarter broader earnings a offset expenses. development per from comparable share period headcount increase primarily were in services. personal in change and CABOMETYX accumulative and to income the in period projecting collaboration $XX of $X.XX per to the Those increase the Net to basic increase million of period for excited allocation therefore The and in expense an result $XX.X income for in consulting decrease expenses the Other continued collaboration expenses percent and compared an The in resulting of in and of clinical in losses tier selling agreement the growth the by the first to by Ipsen for increase organization. Ipsen compared million increase partially trial favorably in this million in recognition expense the Research million the for diluted share we driven general for The of under Selling quarter same loss administrative market were the are was was sales income were in royalty in and $XX.X $XX.X XXXX. million fourth the [ph] are the cumulative primarily since net outside operating for million and the share the million the share support $XX.X expenses a expenses, their and impacted XXXX. expenses in XXXX. be sales XXXX. sales and revenues, in the partially [ph]. research XXXX. quarter $XX.X in territory. net income the loss administrative result XX% increase general development XX% top $X.X in quarter increases increases cost of and million for net and and and quarter primarily of primarily see We $XX.X in The net product compared Genentech’s million CABOMETYX of $X.XX for The diluted EURXX.X personal of the or comparable quarter of administrative are to reflected by offset Last in to launch $X.XX increase third week, quarter. net reported is and XXXX. expenses compared due approaching in milestones per Ipsen basic [ph] our were for for decrease other a the period per or of comparable are net in activities

compared of investments to earnings short totaled XXXX, impact per At million and be partially offset results XX, December cash collaboration long-term retirement milestones, balance of operating XXXX, $XXX at restricted XX, approximately as September is the milestone upfront share $XXX.X million Cash cash investments and the long-term of million. per our two partners. approximately payments and equivalents, XXXX. and $X.XX in of primarily Excluding share. would The debt cash $XXX.X and of the these lower first and from the half the receipt flows of cash by

for our to Now XXXX. turning guidance

are be $XXX Given Schwab. million we end, operating the will over now we $XXX Gisela estimated that between year expenses are our approaching tightening XXXX million. turn with and to And are call for I that, guidance to that

Gisela Schwab

status the I with I cobimetinib the to in study you, provide update the development. program will for of immune regulatory progress cover our on I'm of RCC cabozantinib the on Phase on checkpoint cabozantinib X filing program basis of an development CABOSUN, development combining pleased with in second-line first-line a Thank brief inhibitors. update our and randomized Chris. CELESTIAL, HCC, the close quarter. the the will

with of randomized the the the in for improving collaboration to sunitinib survival in highly PFS its the significant X.X-months cabozantinib significantly as to investigator, ESMO compares Institute, First, of sunitinib in radiology progression-free trials PFS or with poor-risk of Results with treatment first with HR a X.XH and alliance intermediate in as P-value cabozantinib and cabozantinib X-months of the and this trial committee improvement in median compared were cabozantinib on by images the arm I'll on Dana-Farber the that Choueiri sunitinib. progression-free CABOSUN. X.XXXX. independent in NCI-CTEP X of start Madrid, Cancer At survival to review the was by conducted trial confront patients. first-line clinical compared RCC primary XXXX, analysis on presented trial of based oncology from a trial Phase investigator sunitinib. at endpoint assessed this the an met Dr. principal The Toni the radiographic the from which year Conference ESMO presented The

the completed first-line XXXX. XX, February filing review of RCC the was these in for and with basis accepted date mid-October the by NDA mid-August of filing supplemental priority FDA and results, PDUFA On we a

we'll delighted future. the are progress update with in this appropriate We as and you

second-line trial in have study I'll The study sorafenib endpoint Second, X enroll of HCC. update the brief our provide with patients on CELESTIAL; completed The to previously allowed is enrollment who primary per systemic of designed globally. randomized, the two a prior survival. received protocol. trial overall The is patients total placebo-controlled Phase was therapies of a

the XXXX. ago, NDA was compared data to survival first trial overall As benefit statistically the committee the for submit we planned placebo. With clinically in expect and fork and announced second analysis now this we [ph] demonstrated a but result as meaningful interim the two weeks supplemental and of independent quarter significant to the in-hand, monitoring cabozantinib

not order disclosed results. study the present in ability from preserve the to the and have publish detailed We data the to

at the an and to are results the we outcome delighted However, conference. look with upcoming medical forward presenting

to turn to like for update; development topic lifecycle broader today's the management would plan I and third cabozantinib. development the program in Now

inhibitors, wave with We efficacy checkpoint initiatives and provides and and Genentech-Roche. BMS for atezolizumab The action cabozantinib various collaboration trials evaluating very have inhibitors opportunity in shown the cabozantinib ipilimumab in forward. such cancer Cabozantinib immune compounds checkpoint very with nivolumab, of of active the and immune with compelling indications. the in for multiple excited next are a about all different moving approved mechanisms are late-stage of combination combination

evaluating RCC The are or in X We and RCC. and cabozantinib compared study called BMS, ipilimumab as of to study and both objective first-line response X,XXX-patient CheckMate is untreated of primary endpoints study initiated cabozantinib, progress as been alone, advanced cabozantinib ipilimumab the and and endpoint nivolumab very overall PFS survival, pleased combining planned with nivolumab sunitinib with Phase XER. combination nivolumab our rate clinical in and collaboration or a patients safety. The about nivolumab the previously include secondary has with in

of HCC combination of cohort in evaluation XXX we evaluating response objective safety of trial run patients immune secondary in an development therapy. significant cancer have is objective cobazantinib advanced is with with front-line nivolumab four combinations patients This progress combination cabozantinib, with Genentech-Roche a The and of safety patients Phase as PFS. made the study CheckMate and X and has Additionally, is cancer, planned we also of and and include collaboration checkpoint part evaluate the bladder our Furthermore, advanced patients important with including bladder inhibitors cabozantinib preliminary enrolling primary study cabozantinib, different in RCC, with ipilimumab This in activity think as and including been the dose-ranging expansions about and HCC treated trial trial in with previously initial and untreated objectives atezolizumab previously an the to the actively. previously nivolumab ineligible patients. settings, with of both further cisplatinum-eligible initiated. combinations untreated and rate the is

are both participate study agreements. be indications and and trials accordance Takeda, study. and Further part earlier a discussion Additionally, each studies plan in under was This in with are further the to patients their opportunity partners, initiated Ipsen the in enrolling trial. future of in added the our dose-ranging in have combination additional year respective this collaboration this of the [indiscernible] to will terms to

types. at other and non-small various to program addition cancer, also review immune cell trial Phase in negative cabozantinib through efforts, concepts preparation study inhibitors trials breast multiple and investigator-sponsored lung X In internal checkpoint cancer are advancing combining with clinical triple including and several partner of our there cancer, indications, endometrial tumor and our NCI-CTEP

cobimetinib program that development the milestones includes a trials. brief with important made So And close, the the To this in in look you progress cabozantinib updating pleased with to three our to reached forward during the Phase and summary, ongoing development like quarter. future. in I'm very I'd update X program provide on clinical

and fully trial first First, as which was expected quarter on with results third-line in third enrolled for combination quarter carcinoma, of in in XXXX of by atezolizumab the communicated the call. which recently the year IMblazeXXX half are colorectal this Roche's first

locally cancer cobimetinib Second, the TRILOGY combination trial in open and and a X previously combining for melanoma. and trial, or the metastatic atezolizumab cobimetinib that is atezolizumab. metastatic This wild-type of advanced study for previously mutant-positive paclitaxel earlier-stage Phase Multiple trials also including the of with BRAF combination with COLEC is studying the atezolizumab IMspireXXX, will in untreated now BRAF IMspireXXX enrollment nab-paclitaxel trial X in triple-negative progress, additional with are cobimetinib trials in vemurafenib breast melanoma. A third, without cobimetinib Phase of with patients. untreated and also or combination

and So, evolve. lots front updated P.J. of we activity that, cobimetinib call things keeping look forward on the will turn as over the to I to with you development And

P.J. Haley

Thank you, Gisela.

QX and compares see net growth end million. to the QX approximately increased $XX.X CABOMETYX X% with of XX% the net is patients by from approximately CABOMETYX performance prescriber by Wholesaler four hand. on with to CABOMETYX in favorably franchise week for continued driven continue starts, quarter-over-quarter. on of Demand customer one weeks and total already of QX representing We growth revenue in patients therapy increases cabozantinib of million by $XX.X three to million strong revenue of in demand base. the net $XX.X new expansion the was revenue QX. product increased relative of refills inventory range

of through agents. we channel prescribers The New second IV the setting volume RCC more and volume the and effectively mature low market large a increased share with market total ordering of the with by there are increased increased beyond by than specialty accounts number distributor CABOMETYX line in to small a as a and XX% both oral the through than prescribers. written specialty in compete who number XX%. to QX XX% that continue prescribers pharmacy of more have patient high is plus relatively number number channel

market Our effectively we've in the CABOMETYX been high-volume indicate that competing the data of launched. segment since

base broadening in be the driven focus believe of suggesting to growth key growth community Approximately by for strategic efforts QX the was our QX our we adoption came continues the in team. the oncologists segment. So, are saw continued from prescriber we XX% primarily promotional community that a which

share with if ensure at very advanced a opportunity to the CABOMETYX. as generated market competitive, is at level has team very work voice from RCC we experienced benefit and a not Our to high executing patients leading of appropriate

in we represent that beginning to CABOMETYX RCC indications in Given fourth tumor pending approval. new followed and a FDA Gisela through CABOSUN the potential milestones driving with continued cabozantinib third described, the HCC would franchise potential forward line of label a expansion look first indication growth a on for the label based by the which and

and ready data which base line expansion knowledge on well RCC a potential launch approved. deep RCC way before Exelixis we the based date. in CABOSUN expertise indication will is should on approval or launch first will for label the market Our well has under service PDUFA come planning the be should developed and a be

Additionally, there launch are line potential many accelerate a will synergies in that first RCC.

the prescriber time relationships team and is for the For physicians. RCC with lines the have our later prescribing RCC second CABOMETYX of may base first or will established new help in adoption prior of prescribers facilitate experience majority same these setting. the the has experienced the line example, approval, which At

most accounting in the many significant liver combined. to now line cell deaths near patients in which recently has are the approximately common the there one significant majority the diagnosed cancer systemic XX,XXX Hepatocellular need on approved been carcinoma the line under patients term. XXX,XXX of renal year is CABOMETYX I was opportunity United for medical a XX,XXX each first XXXXX. lines as form This in turn for cancer States. accounting are This The cancer nearly second only cases nearly market long States. until as approximately liver deaths as served for United unmet there of first the will a are carcinoma primary There and the is a setting patients growth therapy. basis. US annual over is third globally with and an liver year. is In

to continues for second plan team line FDA indication pending Our potential approval. HCC

to leveraging brand. mid-term In of the CABOMETYX TKI growth inform become TKI second CABOMETYX commercial research, differentiated future for leading Exelixis unique in prior our revenue line near on conducting HCC based team the the in In TKI already represent RCC million. net of that anti-angiogenic of is data CABOMETYX well. addition experience settings mechanism is preparation. to as of QX as the one the the of and RCC has choice establish in $XX.X the well market to its of some first members to Cabozantinib our line clinical line is opportunities potential we're with and have the action. RCC the in later HCC potential choice second of mission market

Our to call motivated compete I that With to continue eligible the day bring to of focused benefit team continue every build as CABOMETYX and turn franchise. is will back every Mike. the to of momentum positive over patient we on to to the the

Mike Morrissey

include I’ll progress of aspects performance milestones cobimetinib. close the and the pivotal significant Phase that in achievement made development the saying business. for third of all in X cabozantinib of and by the solid RCC, Alright. and regulatory our across strength of we quarter initiation advanced continued organization Thanks the trial QX the and with launch CABOMETYX continue from the P.J. the Highlights additional new

progress key in to in and trajectory have reshape the line the first include term potential submission. milestones for we three, They our with XXXX cabozantinib regulatory first QX, RCC into Going near beyond.

and outcome celestial external review and the [ph] half for XXXX. towards next which rebuild top the regulatory of efforts have opportunities success the Recent and the progress QX of progress and line Second, line guided explore trials combination cabozantinib internal pipeline cobimetinib provides to and the wave on pivotal the first indications data licensing assets. of position based IMblazeXXX R&D our our colorectal And strong cabozantinib regulatory HCC to has atezolizumab with for important in for in microsatellite stable cancer the and trial. third, of second of to as new a clinical strengthens the we for of subsequent foundation XXXX and study of filing

and relaunch brand, a team we cancer mission As of Exelixis be I'm this live we longer. proud the work Exelixis as help our to of are outlined part with with on patients on stronger our to to mission. urgency in focus recent we recover deliver and at

we While possible patients vigilant as remain we as quarter impactful in mission had a our making with good in cancer. for QX,

we open face you the now we and will Thank team, happy for that science and As culture to the our embrace your opportunities both the interest you to have as we future. said support and mandate advance the previously, for call We on our continued questions. to the and updating progress. forward look we’re in Exelixis the business in we

Operator

Eric proceed. you, Thank Schmidt first line come & sir. from with our And [Operator Instructions] will question the Company. Cowen of Please

Eric Schmidt

terrific Good distinction survival congrats that couple for overall HCC when as CELESTIAL data, both really statistically always significant you progress. well you're data Is Maybe a afternoon an you as meaningful. important are and of about months like on talk making? clinically the that last Mike the reference it sounds

Mike Morrissey

date. very You a and to it's, not the any a data of press to statement think I make maintain is presenting presented that think important we later data the of viability important sort which at release it's to know having in relative accurate

pivotal done remembering that, past the other for same correctly. that we've that terminology in we've So, all trials if used positive I'm were

read be out you what view the can and how data look how you it that take I at want people comes themselves. that viewed and So, but is once I into it'll a can we think think

Eric Schmidt

unmet survival which an this I clinically mean population wouldn't is significant? you overall be that reference need there advantage in

Mike Morrissey

on again, to wouldn't want speculate I here. hypotheticals Eric

for large. I new think the is for new opportunity compounds, agents HCC

the some at in obvious those the both and agents. disconnect of and as and drugs that of for approved It's between uptake do I is it important sure and of widely currently the and underserved US globally. numbers would very remarks the known we some in When the look that indication. As that early really do, are you numbers his available P.J. setting the some say widely through of underscores went prepared current I'm there epi you the,

the we're progress excited and HCC on with the idea cohorts pleased will earlier the some obviously about XXX combining between for we where if very one with have additional is we and study data with the analogies very nivo cabo one So, and of making Phase there you study. We're are RCC as cabo from opportunity. that HCC nivo line that and find will an or we the in interesting with more once ipi hopefully II that pursue BMS

Eric Schmidt

all Takeda us any your Appreciate the Okay. thoughts or with to within to in data there. what options? Could so Ipsen you remind opt CELESTIAL just also and need economics they and whether if those say

Mike Morrissey

milestones Yes, to those we’ve clinical so I have with achieved There into before yet I’d opted commercial with indication. wait with do those don't parties worry say economic deals. we think are that those and both significant and must I regulatory HCC rather for that.

Eric Schmidt

again. Thanks Okay.

Operator

you. Thank

Blair. Our proceed. the Hsieh of next William question will Andy with line come Please from

Andy Tsan-Yu Hsieh

CELESTIAL stop. before But my to do I the a that, is Exelixis space advance. even tough early on just where wanted the considered non-inferiority a major taking congratulate for If I team questions. Thanks tough

mentioned you given efforts [ph] SG&A about melanoma. kutalic the line thought HCC one it CheckMate And recent And question that are you potentially HCC. and back the about of Exelixis front-line sales forward. is the also promotional spend study second two study about have I the and detail of Genentech there? Opdivo space? going I Have pivotal approval scaling force believe in that the Is to and your So, needed is XX-Q questions in accelerated a first XXX the is second especially

reposition So, the is HCC? it to sales you. for Thank possible

Mike Morrissey

is to P.J. then on with why start over Okay. the ahead. we Go for so think Yes, XXX those thanks for study pivot and the three, There all Gisela I two. don’t we’ll other questions.

Gisela Schwab

and pivotal the the and look nivolumab potential Thank or and question. in nivolumab cabozantinib, is outcome to of for designed of cabozantinib the study nivolumab you safety combinations activity space. study. positive CELESTIAL We and Checkmate not given forward much really as data the ipilimumab of the very the the XXX a a

So, we direction. are forward in thinking certainly that

Susan Hubbard

Gisela, can for patients you this - question.

Gisela Schwab

patients. first and for you Thank reminder. the line Its second

P.J. Haley

Andy. and there talked line thanks we the the salesforce always and redeploy because really to in we’ve mentioned But significant line with where about two as we’ll the the it cobimetinib the patients. salesforce to regarding back force commencer here. currently XX scaling questions sales regards take the opportunity. or sales and invest space. those of to Q us the With XX,XXX for Well, the gives which I right you opportunity personal with we with promotion opportunity we’re We’ve preparing we're will you COTELLIC disclosed excited RCC as partner CABOMETYX about first promoting now the is Genentech we’re launch representatives second actually for know HCC

experience the of cobimetinib. the term from the So, that market. to we’re RCC looking near reps future forward to In way in deploying those regards no does in with take away our excitement

III BRAF cancer. wild-type, third in the Phase described and mutant-positive combination study line three Gisela near term -- there melanoma ongoing and studies, As the colorectal are certainly in

So, and there. developments about we’re those look forward more excited to

Andy Tsan-Yu Hsieh

you. Thank Great.

Operator

Thank you.

Piper the come line will Our next with from question Jaffray. Tenthoff of Please proceed. Ted

Ted Tenthoff

you. congratulations My as Thank Great. well.

regulatory next little filings year. of bit a see start question and approvals rollout housekeeping we a to I have actually if data As may. and additional some I

should about going look more the are But line? I NOL’s two more how decades towards people now to start looking rate trending? that we a that you've thinking and to be years crossed congratulations company. here bottom expect through. Where Obviously, sort profitable Just be over to tax should work of as maybe we think as have at this a couple we to of

Chris Senner

Chris. Ted this is Yes,

it, can during expires we income $X.X go when the point out income, billion that of out on XXXX assumptions Federal So NOL. - model the all when basically way as those. last we going first on I extinguish that a of That we’re view to we and at had of go so look out to XXXX approximately out your reported XX-K in the all and figure based you your from from

incur Now states didn’t Where the taxes and X% we NOL we for operations where or rate we liable certain average effective had didn’t taxes paying we now haven’t didn’t are did those state that states develop, we for tax are operations. that we’re X% pay in so have on we where previously.

Ted Tenthoff

That sense. makes Thank lot of you.

Susan Hubbard

Thank you.

Operator

you. Thank

question of Please with Peter Robinson. from Lawson will next Our SunTrust the come proceed. line

Peter Lawson

just Mike, kind see Hi or first after line for second RCC force guess Where Opdivo I its as of line thinking the next and in for sales you forward years. well? if question couple liver the the do say focusing same of

Mike Morrissey

about the closely the paying operationally the now years a and professionals somewhat of hesitant off different clinical to that's thanks and activity four track work and the around think out got something opportunity I’m said ahead. them have, focus. where done a about as we’re the three indication we really play cabo what couple ourselves help field both the from potential either going be opine Yes, with had as for that almost great well trials seeing Look investment as a to to certain we’ve effort and I across MTC single vision. second worry Peter. degree next strong the that's meaning do people it office that franchise team and upon or speaking. combination with the types understand us the with one bring we our help at to still I really a can molecule science, cabozantinib to work, experienced line we've or and as RCC. be this the day that side HCP’s in I seeing pivotal educate preclinical of that home on is indications really the the or approved a think lot activity you're whether week And commercial question effectively tumor a years more. over very in ability We’ve the of different value have indications P.J. that broad talked it agent as opportunity what that's multiple broad now deep is and And work being to

opportunities show that broadly continue cabo relative I like to be good a sales those we bring trials, forward gambit well a hope terms to we can years, to of pivotal trials. have in if executed be delivering So, that force to able a of in we well fast controlled if data to in is benefit covering the of couple successful

again, to But we're So, about how happen. what we the may every there patient moving out lots that focus, want are it's relative our certainly that that’s may will the day passion to time liver will again that and and talked we drug hard in getting will or to our sure future there make or as renal with of that's time. continue not play eligible every pieces to tell predict single

Peter Lawson

second after I/O line are you near-term that head to to really frontline? opposed Do think going the or as around possibility of head kind benefits

Mike Morrissey

I/O based every again how to line to I think relative that we from eligible patient in every, address that plays will might first again and versus able benefit be cabo be I/O all a roll RCC and detail second line will in to upon across based to those very ready our fashion. we upon be different will label compliant gambits our again ability

from be how out a out the in to me like terms hopefully data, data XXX of then plays that then too approval How without how again combination and front that the plays of have in works field I’d feel making plays We'll much able as how better projections about well view? any that alright. as in looking as of see, of to kinds how regulatory well. to eventually its point So, both CABOSUN data farther ahead the

Peter Lawson

you. Got

are Just thinking how that or finally building around and is in it acquisitions, front you center that? as about cabo

Mike Morrissey

I yes, pretty about Well talked this think previously. we’ve extensively

I many anything is upon based have that shouldn't cabo is I ability knowledge the and think one probably believe be the that’s around or I’ll say certainly I strong a we priority and so So, and franchise our what simple we and pretty to-date clinically commercially. now foundation patients and we more over activity have its to mean Again, treated X,XXX new. think being a be number molecule.

currently assets bring right. doing going out the put process looking and interest of or data all about that’s either up risk diversifying I'm and which competitive to do various been put and combination strong trials pivotal to don't started external well to So outside the, our certainly that the there's portfolio formats. and commercial to fed But new ongoing I for want can to next based and we in as and internal when navigate upon first jump strong again, and value it a we allow get when us I very of of portfolio again, would very in regulatory that discovery everything cabozantinib trials as well clear gets we've single will confident on aspects next as And and comes comes starting to analysis that and I/O in say resources making the landscape wave will rebuilding the start sure that it wave agent around.

to going bar we a details we work are be done. we and all and buy. buyers have going But about. a we’re opportunities and or to I we’ve got that several very for Now now go diligence finish very partner we've going foundation sophisticated and bring through weather high late we're we And have stage scientific again, to what house we the think in and undergoing got those and we're be the good excited to have to get

again as line. an that’s, able go on supporting context last we about the that with and I our assets of that’s we're we talked but think proceeding we that’s grow the that to cabo in I overwriting think new strategy the grow important forward want to years for still focus to we’re how the revenue of consistently going and operate while going now the And forward. we’ve expense couple be of part line the So, how idea

Peter Lawson

Great. Thanks so much.

Operator

Thank you.

Capital question next with Markets. will Please proceed. line MacKay Kennen Our come the of RBC from

Kennen MacKay

reaching expense of Wanted is that of questions cabo could It’s have here. the long and pick and indicative if it’s you on of my the in a there. taking whether team quarter. comment to on disciplined wanted ahead I sort I in stockpiling was a whole that think on hoping Really on Mike was perspective inventory some really for for to just get to some been road build congratulations Congrats price there management. profitability. the quickly see you I thank you Hi, there question whether early a housekeeping October?

Chris Senner

Yes, Senner. its Ken Chris thanks

did his week increase one As inventory the by P.J. did during we approximately said prepared in - quarter. remarks,

to that it. to hope we are closer range We’re target three to our still four-week be within within or

Kennen MacKay

Got you.

of sort Okay. Thanks. And of the then RCC the more dynamics market. frontline one on

is second sort here, setting in it versus approved approved much the probably and RCC. once here. in Just line the line this community Is third plus of more its or academic more clinics clinics

how Just currently are cabo? that on a how of out get you versus marketing perspective shapes wanted sort to

P.J. Haley

P.J. third With answer line it’s the taken then third, opportunity setting first and to and is mention that. regards happy Hi Kenne, the second setting this line approximately to the second a larger I as as together. the same

it's But the in leading speak tied significantly over market most and surveys. quite frankly really think about is RCC little CABOMETYX for is quarters the forward have into expanded similar split, community prescribers sales I these to maybe that’s on few base now force a all with and really in say I’d regards the so moving share voice bit prescriber that. experience important the academic to With we’ve including it’s our and last majority So that excited there why the more the the roughly happy community we’re of community. or prescribers that of and

relationships we’re the suited and the feel the that's on building really term we first expertise in to in in So approved that with community that in and those that have to line well established important, in really we’re that near house. here really do we've event look forward the

Kennen MacKay

Thank Operator you question. you. for Got my Thank taking you.

next Stephen with Our of Stifel. the from Please will proceed. come Willey line question

Stephen Willey

another Yes, good and questions congratulations thanks taking afternoon on and here. quarter for the great

you nivolumab second of think point? about patient this I up of in being front trying I'm moving second know what guess at opens the line the P.J. share line Do what for talked to that think plus happen market at I new the think market that just now are to I proportion patient about in XX%. context you number is you line?

P.J. Haley

Yes, for the thanks question so it’s P.J. Stephen

good is plus with as we Not mentioned, and As agents base. prescribers evolves you expand there the oral refer with feel which other we forward. well of second to. say that’s to CABOMETYX we our sort very I and competition line that are a experience prescriber having until IV see line kind are market of going with very share moving than second probably competing we’re the and comment there the how beyond that XX% on that the as market pleased and But we

Stephen Willey

Okay.

just RCC likely nivo the ipi, risk within these growth be So, I’m with and patients you’re guessing you'll kind some amongst competing most base setting. among some trepidation have community utilization in given you inherent still for there's prescribing talking and of an community about intermediate front that prescribers? think prescriber these you the Do the poor line advantage ipi of setting that that around of

P.J. Haley

of the the (indiscernible) is. for what in is that’s the say follow-up. market Yes. and now sutent majority where I think I'd I’ll of Thanks Well, so the is vast kind the share community really just with market

there certainly comments the first oral really said confident kind off that play in are in we of in any is are we I think as hold compete have the making the setting. relationships. community effectively out, things I to plays see that do But until agent we have opportunity we’ll the we really certainly well but line convenience again, on which how

Our share to we of community the already feel effectively. voice throughout is and strong compete

Stephen Willey

I place then lastly. for just And about Compendia now maybe two, you’ve and months. guess a guess I had two in Listing half

with in Just Thanks. there can as uptake you kind setting just curious result anything if of that to of a the far is front-line the thus say respect reimbursement?

Mike Morrissey

are label and don't comment know off to. indications indications comment that regards all are approved promote we Well, the to we and Yes. obviously only we you first with currently. on utilization of don’t settings Well

there it now. So, I’ll just leave for

Stephen Willey

Alright. Thanks for the taking questions.

Operator

Thank you.

line Schmidt with will from Leerink come Please question next the Partners. Michael Our proceed. of

Michael Schmidt

HCC the with commercial and support regarding on need feel was quarter line Hi great terrific team do and guys, and the expand execution. to the as thanks another taking question have may next first the year commercial launches? RCC team you congrats missed for to I if well I my wondering

A –Mike Morrissey

potential line your first RCC. compete for for and with term to Michael. we indication CABOSUN I’ll there near we’re ready well the regards to Thanks feel say is certainly suited the in What question and very

always of and scale representatives been have had very process organization they're the experienced earlier the in talked with on mentioned RCC years opportunity the sort to opportunity efforts we CABOMETYX. of just the XX to will (indiscernible) as redeploy the a cobimetinib, from oncology us beef redeploying with that As about and we’ve for I up now of we commensurate couple

So, we’re excited about that.

near So, our we a get compete, we in really term. good feel opportunity here to the should label about

Michael Schmidt

do miligrams study just Okay. And at then in is remind just Can doses and this or collaboration move the of the regarding several cancer to And me Great. then into liver looking looking you you cancer. pivotal position is in regarding CABOMETYX be XX done? day potentially study breast per when with the XXX a might think that you a it at just HCC? CheckMate

Gisela Schwab

Yes sure. thanks Gisela, This question. is the for

variation Regarding isn’t a or XXX miligram the study, the ipipimumab. combination alone with of nivolumab CheckMate nivolumab this XX and

was [ph] that are MCI there delighted from but in And a (indiscernible). been when So probably with by plans, say ongoing are evaluated certainly presented been later at very forward study doses has the we Ib the first to XXX forward, Andrea regarding it’s have that Phase obviously a still data previously premature to seeing and drawn CELESTIAL thinking combination. the was little the of study line the about looking and future outcome

Michael Schmidt

the all on Thanks, congrats progress. Okay, and great.

Susan Hubbard

Thank you, Michael.

Operator

Deutsche Thank our with you. of question line the Bank. come will Please Andrew Peters from And next proceed.

Maryana Breitman

progress. and is Andrew. this of is taking Breitman previous Maryana on questions few, RCC. about opportunity Thanks had for following-up kind on in congratulations one the my Yes. Hi, basically all them I for commercial a of questions

line once We’re you opportunity or data up inventory slight on nivo, available uptick then term thinking the profitability you’re an and And to going expect how begin was as do demand I are shape a I kind the the quarter. how But to well? on do current just You I should the couple think you buildup. wondering going dynamics? just longer we sustainable wondering had a is to rate ramp have quarter-to-quarter to ipi of first the I do OpEx commented inventory, how line of as about run think questions was initial for it’s see cabo as how wondering mean about is and like studies change like in this quarter first over also changing you

Mike Morrissey

is lot’s There there. Okay.

don’t the RCC on and why go with first with Chris to we’ll stuff. OpEx the then start question we So, P.J.

P.J. Haley

in the will I question guess patients for the to With lot about are a what large the should, XX% a ballpark I say I first RCC the now. first to getting thanks majority won’t for Maryana. eyes XX% patients vast regards Yes, is of about that’s the of XX,XXX expectations line, performance market line there. But and which in is

So that’s practice of US. now the in oncologists kind of the current habit and

opportunity and a experience utilizing where there certainly, be share will good and problematic these are mentioned that So prescribers expertise. have I significant likely voice as of will and we a

compete well we large brand the feel forward to there suited the grow in that continue market. very to to we and look potential to So, are

Chris Senner

Thanks Okay. P.J.

this So, is Chris.

the the on going business is that to revenues what invest in is we're what to of continued have investments the of say have which us. future around and and continue did along I we but profitability So, discovery the that we as growth we're in to Organic be will guide the primarily and our will year. sustainability business been our profitability And lines also development business saying the last not that that of such of question front end our the cabozantinib business restart in development. opportunities investment we the at in development going

things that be the be and revenue lines of growth. those we’ll investing in the will be that So our along will

we have guidance point the profitability of of from view. kind that’s the So

Susan Hubbard

just final her And the Q-over-Q piece impact Okay. of. is

Mike Morrissey

take that. Yes, I can

we’re the continue is the expect had quarter on had into So, over I in we probably think quarter-over-quarter very XX% as we at going share few pleased QX. to QX, we’ll here. comment certainly X% to with not strong. think growth weeks QX in we’re QX But quarter to am sequentially. the only reasonable not It’s grow I I that

in second near plus Happy there. the we’ve with with competing the how share line achieved market setting. pleased we're We’re XX%

combination the base the marketplace in have in growth up knowledge just and in CABOMETYX and XX. the pleased times, away near mentioned particularly deep which think us sort we’re that the with months approval a with we date I couple potential experience As of here we’ve sets CABOSUN for in of adoption couple future really a I prescriber the well broadened a indications term really February with PDUFA the

So, to looking forward that opportunity.

Maryana Breitman

taking very Got it. Thank you, much so questions. again Thanks. And my for congrats.

Susan Hubbard

you, Thank Maryana.

Operator

turn back this the At today’s so call Susan I time, questions, are Hubbard? host you. and over Hubbard. further no there Miss Thank to would

Susan Hubbard

any you We to call welcome Thank get didn’t so may we and on us additional all Brian a that today. certainly thank address chance you for today. much. calls with the have your follow-up Thanks questions joining you,

Operator

a you thank conference. on all your conclude gentlemen, wonderful day. may and we the program does participation disconnect. This today's have Ladies Everybody for and

Exelixis (EXEL) 2 Nov 172017 Q3 Earnings call transcript