EXEL - Earnings call transcript Q3 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Third Quarter 2018 Financial Results Conference Call. My name is Justin, 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’s conference, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. proceed. please Ma’am,

Susan Hubbard

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

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

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

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

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

Mike Morrissey

a of to financial thanks as Exelixis and commercial you, level high third the Thank everyone All maintains right. on we QX. call today. strong and for clinical, a and had us Susan, into joining move execution quarter

team indications As and launched our expand CABOMETYX, studies to today, wave a revenues, you enabling advanced grow from rebuilt potential plans next hear QX. cabozantinib in continued for to We with pipeline. our label will cash the and earnings, of

Importantly, we for business. CABOMETYX, see growth tangible in QX RCC the

put, never business has the our and share competition TKIs QX increased other While the market Simply revenues negatively been our and have impacted in this of stronger. company indication.

optimistic inhibitor face drive We’re from can of the immune TKI competition that strong to cabozantinib’s best-in-class growth continue emerging in checkpoint profile based therapies.

to on our determined earnings for first, strong Key financials, activities. commercial carcinoma. highlights for revenue, for cash goals the I’ll QX in the of our and includes, renal day our CABOMETYX Chris, call Gisela to single performance development stay providing XXXX shareholders. cell begin commercial key advanced significant details growth and We’re focus the by cabozantinib on the in performance and CABOMETYX then for a on brief today QX based our and and and over for both P.J. milestones patients additional turn summary deliver QX every

recent revenue Third in earnings CABOMETYX the NCCN role revenues update quarter cabozantinib of Canada now strong as diluted of the is differentiate the CABOMETYX income of for RCC other of EU business, TKI. METEOR approximately the revenues in strong The the QX continued million. RCC net the quarter recognized was secondly, regulatory $XXX the previously majority key total continued of as in TKI share. both the this $X.XX $XXX performance where patients. $XXX additional continues CABOMETYX business, RCC per the best-in-class milestones CABOMETYX provided of treatment performance is and untreated preferred The now the approximately highlights of The refractory of to totality million net with TKIs million. for indication. the vast Achievement from CABOSUN – where cabozantinib of franchise approved and the milestone and led were data and to

cabo’s shortly, describe will recent Gisela to updates those at or as as RCC As ESMO patients, negative in patients utility potential highlight refractory ICI monotherapy previous well treatment. PD-LX combination

program. regulatory Third, the are cabozantinib advancing we aggressively development and

in combinations. Our with from data positive is the second-line both review HCC FDA survival for has sNDA of filing and XX, under encouraging and data XXXX. January single CELESTIAL cabozantinib It and based PDUFA trial ISPI on the the U.S. EMA was the agent

and of XER second trial cabozantinib stage the wave trials several startup and next recent a the combination of of thyroid lines for of for COSMIC-XXX first-line therapy. in trial in The of wide histologies and the progress single CheckMate differentiated or Phase clinical late cabo/nivo across the highlights potential RCC our stage phase progress in cabozantinib indications the X trials We’re initiation over the continued of start area DTC to months. late second-line agent of the cancer and sets stage in additional the this range

strong components reflects XXXX of the business. all throughout team’s performance progress across our Our

cumulative the a companies, drug leading momentum billion growth. remain fashion our since becoming build For CABOMETYX rigorous XXXX on $X free managing expenses has sales our highest the to in and on on which while reinvest sector of sales, cash and commercial and plan milestones from includes We been royalties of this to firmly generate to long-term the in therapeutic brand. order and launch to a any growing way business quarterly product in global to sustainable with collaboration focused revenues return oncology across its biotech small, areas U.S. Exelixis, other launched and is both midcap

Chris, So third provide turn quarter who on will details with our the more over I’ll that, call to financials.

Chris Senner

XX%. $X.XX XX, you of compared share million quarter Mike. million very revenues Thanks, revenues per $XXX.X I’m income same and the ended $X.XX for to period Total million GAAP in increase. quarter-over-quarter increased increase treatment is XXXX, year. product were XXXX reflects of quarter change we renal of in at for the for was a net period took total in to net the $XX.X our cell the results basis and in the by $XX.X $XXX.X to September income positive third end the earnings the of XXXX. CABOMETYX third advanced million for of approximate Total financial with million The price share a million million, revenues an share XX% compared of last pleased in XXXX product of $X our include net a GAAP and which of net approximately of $XXX.X the the million revenues which product with on a of quarter. continued of net increase finally, strong reflects carcinoma. growth comparable patient diluted On result the CABOMETYX approximately $XX.X the or revenues per $X CABOMETYX increase earnings diluted million approximately million $X for quarter second $XXX.X demand, This inventory revenues sequential impact

the and revenues ended third an CHMP sales Genentech. reached HCC royalty when and revenues RCC. from our $X our include to increased to This territories, million recommendation CABOMETYX to development Collaboration approximately $XX.X the treatment to well profit EU Our million Collaboration $XX.X revenue in the to and gross second-line earned collaboration Total XXXX, anticipated revenues with cost compared reimbursement XXXX. million of Ipsen had Ipsen include September with quarter the with from due in of following to related quarter of also and second to of was increase collaboration for in million recognition Health in quarter and XX.X% of revenues comparable XXXX of primarily by million tier sales XXXX in approval as deductions gross related $X.X the collaboration second-line royalties the $X.X positive from primarily the of from in increase on for Canada in which period of as share the compared quarter also government rate of the royalties discounts programs. net agreements slightly Ipsen approval our in as million their was for third collaboration million XX, the in of XX% milestone Takeda net was under $XX.X $XX.X for XXXX XX.X%.

continue quarter, enhance these opportunities. cabo of a revenues flow cash position, note bottom we growth significantly that global as revenues us the directly on allowing gains wave As our development to look important to of increasing majority our It’s is attraction component scale. total through as increasing CABOMETYX flexibility and an and revenue this of line to business be next evidenced, collaboration our the trials, to research

by increases the were Our third by in total SG&A the licensing which costs and goods sold. Within total of quarter which and million approximately second in offset to XXXX. $XXX.X trial million was expenses our costs quarter costs in and our declined R&D of spend million clinical primarily for $XXX.X lower $X was and largest by costs expenses, of the XXXX expenses offset partially is in increases R&D The increase result expenses. was compared

as costs in upfront Invenra. initiation and short- partner XXXX. reminder, And for totaled has full equivalent, of and our investments investments updated year. the $XXX.X and XX, September Cash finally, guidance the and QX expenses for at to long-term December short- an $X cash a million operating cash expenses compared of we $XXX.X restricted total million XXXX million its and XX, in at form company the of to XXXX, licensing As and collaboration paid fees and long-term

We ongoing related lowering trial tightening primarily million and and the million, expenses $XXX our now timing planned are to combination trials. $XXX to of range the clinical given and

stated, compensation costs will the I this P.J. stock-based million $XX primarily now call previously expense. expenses guidance non-cash of As to related over includes to approximately and turn

P.J. Haley

Chris. you. Thank

to quarter. cabo TKI pleased in TKI goal favorably, the market of in the the choice in our business demonstrated with CABOMETYX share third in progress performance positioning more establishing and by CABOMETYX continued is as strength of made of We QX the gains expand the utilization towards fundamentals, Also, NCCN strong guidelines saw market. third of significant updated academic settings, approximately RCC and and grow We’re of the by groups. revenue grew broad product CABOMETYX clinical $XXX base XX% QX in community to by prescriber The continued and by and more risk over approximately across grew demand of X%. lines CABOMETYX million than net therapy, quarter. we XX%

the for CABOMETYX axitinib increased pazopanib, to competitive prescription the market dynamics, the we that CABOMETYX In in get comprised both Notably, had TKI two a prescription this combination XXXX. TRx RCC limited volume the of approval grow We basket TKI analyze QX to years. of despite volume this quarter over or inhibitor are the nivo/ipi continued IMS oral NRx for has sense year. in the of evolving These of competition. pleased the last a the April been kinase first tyrosine have data since better the sunitinib, that the approval in the for its on trends compounds confirm stable since relatively impact and of U.S. order

the volume. were of hand, trends to September market month in volume XX% the On X% competition. in in data, other X% based strongest market even share over in the to volume we increased share CABOMETYX to increased share these CABOMETYX CABOMETYX on CABOMETYX in increased relative saw NRx market IMS QX prescription NRx the and to QX QX by NRx both growth has August Furthermore, and face publicly where grow continued increased and XX%. of available

prescriptions, was In TKI September. prescribed CABOMETYX new RCC the terms of most in and

TKI is kinetics with market. the the Cabo the first-line makes poor overall exiting guidelines updated the first-line NCCN a now is intermediate Also as that the patients, published up the of well XX% risk pleased regimen, September, kidney dynamics trends for quarter. approximately population and in only of are a preferred cancer. for as We that those prescription

or therapy, data in is guidelines will added recommendation the primary thus only also credence options. an CABOSUN, have the already the RCC differentiation RCC for sequence. continue and receive therapy opportunity will from followed CABOMETYX cabo label ICI strengthens to METEOR by and therapeutic Most broad for the ICI combination. totality the who’ve robust the be followed The of in making cabo further relative the by to received largely by combination lends for to TKI strong TKIs. an other patients CABOMETYX subsequent positioning immunotherapy sequencing of preferred and market Importantly, regimen to either ultimately driven This patients cabo

CABOMETYX XX second-line in would quarters. XX% progressed are treatment be We indicated of the received approval is as combination the market ICI the increase who patients patients therapy key consistent second-line on updated been expect consistent be with to to combination nivo/ipi patients. over coming an which recently positioned with choice is number combination for have in with these majority of Since CABOMETYX choice first-line research who’ve NCCN after in agent. guidelines. the have leaders treated their These the the their opinion in that first-line recent of of CABOMETYX the of well ICI the This findings immunotherapy. therapeutic April,

the decision market systemic diagnosed approved to to as tumor form CABOMETYX recently therapy. cancer would a indicate of lines there with in intends are treatment. in been expanded approximately will most we label deaths the cabo resources the as is of of potential to and the even in the unmet to potential to forth represent continued first-line increase drug incidents the need through under of to in a disease, patients therapies drive combination long more addition is on one occur U.S. XX% RCC for has the type liver In new only role multiple XX,XXX globally there will third second-line to more key potentially And the HCC years, advancement opportunity available of increase the year. indication, approaches. In of to by difference are primary HCC treatment patients. for expansion available, options Hepatocellular more have a patients predicts of and receive XXXX, drug are look therapies patients introduced. expected XX,XXX XXX,XXX approximately The to carcinoma from and growth even but greater since which deaths cabozantinib medical an patients in an key to their as treated in will cabo and therapeutic the in ICI Liver market of HCC, indication over the doubled both through cancer is XX%. U.S. increasing there for growth are significant Exelixis treated the common The with coming leaders single-agent only play a the has and more in number annual This grow of these options not each patients that attributed systemic an are liver attributed rates the deaths of receive XXXX. franchise. served opinion therapy accounting U.S., over systemic basis. was become cancer so drug patients increasing HCC is the market number until at significantly research The increase is forward

experienced to We now much the team already and FDA progress the look the forward last pleased CABOMETYX Exelixis pending with that made has our are year. preparation over opportunity to HCC launched is bring patients very and we approval. to

launch treat by and prep the between This is significant is driven oncology. physicians largely indicates that prescribing overlap RCC analysis Our HCC. who there community

market sales covers our combined footprint current and potential. approximately fact, of HCC XX% In the RCC

share CABOMETYX opportunity remaining data do new will have HCC will they approval. We generally the in believe on NRx, will new calling made specific indication team goal to begin the the approval. now update NCCN in We’ve towards to will our to for guideline of the our choice for and the following TKI one the significant where is the RCC accounts continued leveraged we provide TKI increase brand. prescribers favorable Furthermore, by RCC. access number the becoming momentum be progress from the

that We’re benefit of pleased can QX, more RCC many but patients the from believe CABOMETYX. results with

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

Gisela Schwab

second-line I milestones. HCC am I the update marked RCC, was update cabozantinib and program the quarter P.J. development quarter. brief on to with regulatory the provide start will the an on a by first as in important you, pleased of Thank progress

positive for the approval CABOMETYX are in Union. the First, indication will decisions, cabozantinib been European set RCC XXXX. monotherapy with has XXXX, CABOMETYX Commission who therapy. treated CHMP approvals have in of including Health second-line the Taiwan in Serafenib. recent approvals the of Health with been and to and the granted labeled this the HCC HCC January is for review Canada VEGFR-targeted Brazil the treatment States confirmed besides indication international FDA’s If and treatment adult Also who has mid expand authority for for of CABOMETYX The September, approved patients a submission for our opinion ultimate Canada approval for of by brings who and adults further for of its date European the previously PDUFA the in ongoing the September, XXth received this Europe. and United

agent to and single with BMS With we’re the combinations inhibitors focused Genentech immune milestones and management Including achieved, cabozantinib. collaboration and lifecycle on these important evaluations broader with for plan Roche. development fully our checkpoint

initiation As This planned. One mentioned in Phase multiple analyzed survival. start calls, of response response follow have X such cancer of patients first enroll I’m the on XXXX, with to objective little we rate prior who up. progression-free cabozantinib among on pivotal color ago, a are types a and rate making of trial the a progress recently and the differentiated involved trial various initiation total thyroid cabozantinib will work treatment advanced trials globally. co-primary prior of patients A The we and The will patients XXX announced trial in placebo-controlled and this couple XXX we with tumor endpoints of to with COSMIC-XXX, appropriate radioiodine-refractory XXXX a our trial more therapy. in VEGFR-targeted and received of have objective be such endpoint weeks to trials Phase in today. as planning then study X provide advanced please for has

is cancer X treated at study thyroid based response XX% in This separate checkpoint activity a with the X designed patients While of XXX durable the an Regarding and objective of analysis. among for analysis conducted previously This has be XX% that inhibitors. reported interim be to PFS on evaluations combination PFS in planned two will time rate with enrolled. will event response analysis all patients encouraging rates cabozantinib differentiated Phase been driven

The great and cabozantinib the is nivolumab partners versus of This nivolumab progress We to pleased combining Xb Takeda, separate with naive and nivolumab has be in treatment Phase safety triplet ourselves X the this cabozantinib, enrolling RCC are in cabozantinib advanced by alone, in versus is and patients, collaborated and with our continues RCC to and cofounded evaluating dose triplet in conducting study XER ipilimumab, a sunitinib, BMS, X nivolumab or the Ipsen established is for and very advancing globally. is patients Phase evaluated both investigating collaboration and making It begin patients for BMS new The the clinical planned. combination activates with And recommended in trial with study of trial, with study. who combination ongoing and our combination. genitourinary expected together the combination start-up trial the and year. progress with Phase preliminary ipilimumab. malignancies. And are patients as ipilimumab, nivolumab enrolling early first-line this tolerability CheckMate

in to We planned expansions tumor collaboration different progress ranging of in settings. cohort combination cabozantinib Genentech, dose And evaluating the our then also with with make continue study initial atezolizumab. and various

recent GYN and the Munich Agarwal. achieving well was part observed. were X atezolizumab, XX% clear-cell of cancer quick and studies Antitumor trial. XX October of histologies identified complete checkpoint study cohorts, generally of The with cohorts, data cancer activity combination response. by the Dr. various a types, of advanced tolerated few ESMO tumor close, planned are cabozantinib combination seven malignancies, regardless of first-line additional to bladder variety toxicity the and a the no including patients under and preparation term. short first-line combination an durable Grade in for initially start active non-small seen and no malignancies, in various was bladder the And HCC now or Conference an atezolizumab presentation, combination Grade in dose limiting discussion, with cell study initiation observed investigating The presented in combination ESMO We trial. GI Initial combination tolerability including expected have and ongoing this at a with at indications dose PD-LX I’ll including are settings ranging cell Further important summary and the recent expansion response cancer, actively previously and X HCC, showed confirmed conference cabozantinib patients. And stage Neeraj RCC, and and cabozantinib in with enrolling for being dose XX Munich. activity good a clinical late inhibitor of partial X responses including one to with cancer and were non-small or in adverse related events in events X to the expression. provide RCC of are lung encouraging untreated the this up a There expansion

the first COSMIC-XXX from was the late mentioned escalation negative overall follow to be survival analysis, will expression compared predictor survival the Choueiri cabozantinib the important trial and with in cabozantinib or both Dana-Farber who shorter cells the and data in than PD-LX status. the the mature. tumor experience. presentation Also, expression. atezolizumab Cancer and a up of already breaking others study for and abstract progression-free baseline Dr. Institute efficacy this of from METEOR biomarker dose in and data presented of trial and data patients X% a available both by was times evaluated no of to PFS Expansion greater sufficient combination expression the As with is equal PD-LX cohort when presented CABOSUN an survival PD-LX by both

among rate with treatment therapies RCC cabozantinib both inhibitor activities well therapy. favorable datasets improved that Of Mcgregor of two by and Bradley and cabozantinib line among independent activity intermediate either of However, prior active or Dana-Farber for in showed combination prior PD-LX ever other arms of therapy, PD-LX XX cabozantinib irrespective XX% a risk of of the cabozantinib the comparator expression. an categories of activity outcomes factors. patients Institute. or real-world METEOR therapy checkpoint Cancer respective presented that objective to expression or XX% retrospective These across as data Also, risk with indicate From in is Dr. with checkpoint compared VEGF-targeting in sunitinib patients resulted analysis the with active inhibitor as alone prior encouraging CABOSUN response and cabozantinib all with VEGF-targeted datasets,

in So cabozantinib the and you am and the regulatory made pleased this program with I in progress future. development summary, with important reached back look our I call very hand And to updating milestones with in to the during that, Mike. quarter will the forward

Mike Morrissey

a right. growth Thank third out the as put Exelixis you, all we All and in into Gisela. strong had quarter and aspect year continues solid move to see our business XXXX. of

commercial from notable by what provides new introduction. close specifically, cabozantinib the adding I Our performance indications commercial in in saying fully and that internal will external has for important of and financial the said restate commercial been has with QX platform year. across clinical, portfolio trials and the future volatility I and my new through since efforts. been the market decline in product building and beginning R&D will strong we perspective. the recent mid-cap and product I Exelixis a stronger opportunities small oncology recognized a that ongoing financial sector never our

in substantial to are mind key keep to Our mid-cap space reiterate oncology like as that momentum others and recent us small the XXXX. forward. into as move we differentiates we important move and from success I’d provides several issues

TKI risk the our Exelixis entire line Based build CABOSUN, totality the CABOMETYX clinical commercial METEOR from efforts the on and of category therapy, data on strength as of to for First, RCC. and population, positioned choice continue of of IMDC status. target is of independent RCC PD-LX launch the the of will the and

future first- to we in working CABOMETYX a from some treatments. points third-line receives RCC eligible nearly While targeting patient journey are opportunity, towards the broad every RCC where their at

CABO’s We therapies in ESMO they be are expect on market ICI and single-agent need KLO of presented of ICI that and not real-world majority responding highlights choice ICI patients in feedback, to TKI patients success will combinations. the patients ICI data research recent the of frontline post stop combination as these strategies appears modalities. at refractory potential for CABOMETYX Based surprised by subsequent vast utility ICI the to a or RCC and these

and expand cabozantinib seek new the and broad we initiating review tolerability that we tumor when types anticipate combined shows Phase Second, and encouraging activity, XXXX. in safety under has in multiple QX demonstrated to as with submissions with Cabo indications and X a clinical ICI. in HCC trials early with activity single-agent

the potential the to wave data second at DTC of initial shortly. and begun us for study, this The potential of potential designed you now we’re and with cabo/nivo presented trials that will get trials initiation broad has was third label-enabling The wave of excited the basket the study, additional underway combination the ESMO see about help recently trials highlights prioritize of combination. COSMIC-XXX

last generating eight internal as aggressively cash to drug significant we will quarters. flow and development from Third, development, new on business the cabo’s discovery pursue position activities we build our free financial strong

position in perspectives. biotech sector has implications small profitability rare obvious the the both tactical from and are strategic cash and growing Our mid-cap and

thank We I continues their work valued the constant write and sustainable distraction, in and entire growth fashion, in The it’s the Exelixis narrative a drive we dedication next hunt and to more for make negative we’re interest commitment team will the all from us. dedicated your basis develop invest better the could business look for of the Blair. to our count day to for for assets to from our team we first are support want for Thank comes Exelixis remain Instructions] on a Exelixis to [Operator updating We question Hsieh for and as compelling of energized and forward Thank need vigilant on story. continued to that we and cancer now continue hear and major appropriately. that but The and therapies. you. be the be chapter you effective call inspired Exelixis, ahead, as open questions. William to happy daily not medicines and on a we a opportunities focused, the next-generation Andy our be you progress. every by patients Our to and in who always

You may proceed.

Andy Hsieh

got for on Thanks and I if couple of the I my question questions progress. congratulations may. taking a

in targeting DTC. I I-O think How early you First I-O, experienced head you seems opportunities think It about for for we or accelerated several for approval the flow Gisela. is But like any for relapse think specifically the the of about as XXXX? eligible cohorts of talked you kind do for some data of patients, look them do study pathway? COSMIC-XXX into could COSMIC-XXX, be you’re the

Gisela Schwab

the a atezolizumab. data opportunity certainly for of Certainly different is the to the you look thank results combination cabozantinib for COSMIC-XXX Yes, basket with of study interesting We generate lot large the various from forward question. to cohorts. the a and

regarding it overall I last and we go forward, what and data for that will the bit data maturing that little and to profile initial early cohort of enrollment to you updated. we look said cohort, a case. cohort your And And we going will of But we on bit keep of little when forward wait so reiterate be the expansion right to as question, present. the earlier, on occurred. we certainly the it’s you individual of full cohorts have a reliable now updating we expand when as to Just to well are that bit individual depending say the the opportunity so have activity to

Andy Hsieh

Okay. for that. Yes, thanks

study ESMO studies the and with so at avelumab/axitinib. you near these early whole When the PFS So I-O compare there’s X stopped two population. OS across specifically pembro/axitinib, Phase two TKI ESMO pembro/axitinib benefit it’s combinations, think, or been trials, I been

patients. still hand, about XXX, despite JAVELIN I other OS XX-plus-percent On is the Renal think they the fact PD-LX the that of positive mature enrolled the

street think I-O is the the on might perform combinations similarly. I that various consensus TKI view

you or for think there? potential question TKI a Do combinations to various data differentiation this across Gisela. I-O is suggest this Mike out is So perhaps perhaps

Mike Morrissey

Mike. it’s early Yes, Andy, little Hey, speculate comparing been one when on, it’s presented trials, a to especially hasn’t right. trial

yes, we’ve the data saw JAVELIN So, release the and ESMO. at seen press certainly

months that’s surprised DCR. encouraging, looked All I and Phase response not We’re rates, over data. by talked has about think the Xb long the presented XX being been high PFS, data high – that last

state, they steady they it would and else. when that number shape, and compare factors is enroll all expectation of the form. when readout or again, where see, side? out upon by data’s a side they our we’ll in So At those certainly some enroll, depends everything manner different How positive

So, early there. it’s

last We’re upon nivo next have agents XER. for cabo as over survival trials. both of the and charge about leading been years. RCC the strong few excited generation have advantage a various based Both kind Certainly here their

And at that would we’re Gisela cabo/Nivo, So excited cabo/axitinib collaboration it pointed the and about that doing lot there that about as we’re combinations. BMS. and combination be more there’s certainly that, looking thinking out, cabo/nivo/ipi or a whether with

hard the this that got use potentially push move company come So we’re going whole in that data momentum to out we’ve forward and, again, upon the really future. as the will to data based

Andy Hsieh

Great.

are may. if two Obviously, that combinations these Just on follow-up a I using sunitinib.

the if for for kind utility maybe maybe be of sunitinib frequently as now. standard those is used So P.J. in as the second-line might the not setting? What care, Obviously, of a become sunitinib right

Mike Morrissey

guess Yes, thanks couple for a question, Andy. things there. the I

seen more really really quarters. to, best-in-class research CABOMETYX the of as CABOMETYX launch regards KOLs said, rapidly we last and cabo growth certainly think go potentially and and symptomatic ICI will leading become new disease. we we’ve a talked And certainly decline as the place setting that’s axitinib as with generally, and more for conduct utilization who’ve remarks, just I progressing seen to market seen think And second-line. of therapy, certain increases opportunity that few a as in combinations the for with in kind potentially or prescriptions, as I already. the exposed always really, That now think second there in point across lines well immunotherapy TKI create and the my initial the our another as to for in our to first-line lines. out, first-line, the we’ve the cabo patients demand revenue really be in disease, third since And of I mentioned patients METEOR, we’ve think been into I you TKI in second-line certainly going

gives across focused cabo be other NCCN from to that, compete clinical from for every really the to to the really certainly continue on strong do we lines platform and our therapy. patient guidelines, the of us TKIs, with differentiating So trials continue a which data

Andy Hsieh

all questions. much thanks for Well, answering my Great. so

Gisela Schwab

You bet, Andy.

Operator

Thank you.

from Michael from comes Guggenheim. question next Our Schmidt

now is Your active. line

Michael Schmidt

on us a you, thanks Hey guys, Can CABOMETYX was follow-up driven the of help I was that versus of questions. couple more taking how recurring for a performance seen much of third you understand the maybe growth use a teach bit quarter. had the frontline my commercial little in volume by RCC?

Mike Morrissey

Yes, across we’re that, of lines is what Michael, growth I think with therapy. to regards seeing

in refills driven We’re QX that’s certainly new patient encouraging. and growth starts by seeing well as a of as lot the

the of we I we’re in now of to to and the the so we’ve lead, momentum well sort think there. first-line there us sort with because for changes we have positioned and NRx see with guideline that’s of to mentioned used Sutent Votrient think and the I as prescriptions overall I of that opportunity setting all remaining the think do setting, plus really And in still TKI certainly NCCN TKI I second-line, combination. continued can choice. speak ICIs opportunity opportunity And taken the provide the in really in that market. continues in And after there the as in landscape just growth first-line go are the

Michael Schmidt

And Great. CheckMate the looks small design, didn’t just Merck looking at speculate But and relatively to study, like example. want XER combination the trial checkpoint I potential to you it compared realized, differentiation. for it’s around Mike, TKI then a

some a sort be or updates about narrow it’s CheckMate at wondering think I potential and trial. I’m of to if from potentially patients. the data provide two-thirds point would a of pace the number just enrollment able of on guidance you XER

Mike Morrissey

on tell sense primary we I’m once is data, we point but enrolled about not I as again, are its fully trial the we when all certainly normally event you will some the driven. mean, question, have do. at endpoints And a sure

is how we So we’ll timeframe as past. it that we’ve and But, that’s do And coordinate BMS the the in be with as of in that numbers we too. defined on with obviously, kind how a have again, can to we transparent we trials stuff by how those done context actual this and of the work. have a partner

Michael Schmidt

have just then the business business sort last was on has – I development. much point right, health type a strong basket. transaction, R&D order wondering understand. said this focused the stage of, another type or picture bring do And All licensing at that transaction the know of assets that been earlier maybe bigger obviously, financial a past in feel you’re to there’s urgency take sort your context of question, do strategy development company, in bigger to that degree in you to an I an strategy question. great, of of informative product the maybe a opportunity advantage I in capital to And terms of you what into

Mike Morrissey

Yes.

effort approaches very that’s move and been understand. combination R&D at a before, effort for effort of the question to talked knowledge all BD oncology couple and a understanding full our landscape, collaborative commercial looking that we the finance years focused products certainly biology, to strong and between from the last of had preclinical team our forward. and of going knowledge assets As we the kind potential previously and Take about of of as had for now. literally We marketed

wasn’t and middle if on you financial more certainly So company, Again, right in financial of all, the a the then that assets balance this the wanted idea focused that and all was that’s that see standpoint to I to in pre as about cranking that add feel from clinical, a and we’re the fashion. forward early the we’ve of much strategy, the baseline back around And work we anything going. then is could somewhat, to then will, it fix growth. a size XXXX to the sustainable help commercial, a build to we to going do of cabo tactic strong good terms don’t where and way company only do thought-out changing move as and now the look get had a foundation done us sheets, in

We hasn’t to the don’t have that fit do deal but to at mindset to right do want right the deal We it our really just price, a do deal, to a at time, suboptimal has the right changed. criteria.

the relative financial high pretty when have the and comes the to commercial bar numbers side. to We science it and

continue forward. we’re commercially will to broad out pretty we’ve move and when be that to both So find makes got something continuum sense scientifically, a and across the assets. like, us And financially, to we then aggressive looking of that at going net we there opportunities and we

Michael Schmidt

Okay, for taking question. great. my Thanks

Operator

Thank you.

RBC from Next Kennen Capital question comes MacKay from Markets.

Your line is open. now

Kennen MacKay

there. commercial and question the my taking on for congrats much so thanks Hi, progress

And that some on FTE seasonality cabo as later previously some been quite has XX% being commercial like XX% line really a that front Just wanted increase been increase. community is treating it bit. happening was like what’s that actually has sales that this was of approved. is a docs on looking SG&A then And at your quarter-over-quarter? were that incremental prescriber follow-up it down new or the commercial looks bit the questions. and haven’t the to beyond understand little I driven of patients X% where by the increase coming prescriber just more was to seems really about sort risk in coming wondering from. And one base, demand, higher quick in And in see, had Is hoping

Gisela Schwab

one time. Great. a Kennen, at we’ll take those

Mike Morrissey

the questions. Thanks for

the observation that’s in base, your prescriber to think on regards demand right. with the increase So I

approximately you prescriber over have, QX over prescribers. So growth X% mentioned, that’s we the in increase did to and demand QX on relative XX% base cumulative an as and really

So CABOMETYX. who prescribers prescribed who have not people have

we us, I more HCC prepare who in them really the happening your indications prepared remarks. community cabo a So so lot that’s see And there’s to and it’s likely written really happening. the what for have important quickly, market previously example, HCC, mentioned to about of too, are advisory physician for base. HCC I our in than to as expand the that indicates and RCC comment the is prescriber think we do and as more boards that prescribe in in community strategically on new And research that great

question And the the also organization. see not our your year who has the going in the We community. for may then always as RCC the and back going us a really the in business now we the patients see look in gotten gain December, the take to touch healthier terms before CABOSUN size prescribers sort which few to now. our in right prescribers team, earlier, patients back particularly opportunity really really sales opportunity we many more over with those cabo having is the last of and treating HCC HCC the launch prepared are sized at And in great, year So a out about launch. we’ve just I’ll force. given on quarters, that – evaluate of – cabo the and our of to educate experience a launch first-line broadly

RCC a So the when focused I degree high HCC said, is we of ready and have, between as overlap team and prescribers.

go So we’re prepared to infrastructure commercially. and regards ready with to the

we the I place. to the which think of new having these experience as opportunity the fantastic have and have us new provide opportunity kind is operating in leverage leveraged and synergy, capabilities indications or we

Kennen MacKay

hadn’t had new QX. there’s seen largely was seasonality was to quarter-over-quarter these see onto you wondering inventory that And you the was progressing any sort sort you. I-O. maybe to/. was one in combo we’re or relating wondering what then sort front post patients patients you. patients coming post I demand I-O in wondering if if if or about new were line little of frontline, I-O naive a these add that cabo And and beyond follow-up Last effect prior a bit some question change inventory. so true on just patients saw the Got commercial I question I TKI starting patients quarter the new Thank were final I therapies. here. some RCC of that patients there talked was the of

P.J. Haley

start it kind in inventory. pass what of with I’ll patients I’ll then discuss Chris to the quarter maybe we saw P.J. is to and new this Kennen, Okay. off

those certainly therapy significant yet that, starting checkpoint across seeing patients what of to therapy is on that market I’d we’re early majority patient immune say of amount seeing ICI going and really progress who that we’re encouraging quarter, a research we So patients the conduct we’re combo inhibitor we’re the to really of see certainly are did see the progress. sort combination are see that. on we days What’s not on to of in and all new say CABOMETYX. progressing we’re in terms starts, last continuing

consistent heard, which in, are that’s new good. we we’ve come patients seeing first-line. the in also what is with So And

in it’s therapy as a across say the treated The I mentioned, lines very But previously sort of and growth dynamic now. combination coming is I’d second-line I have mix. population increase that market So particularly will think checkpoint as of we quarters. an right opportunity for immune inhibitor

Chris Senner

Kennen, this is Chris. I’ll inventory. talk the about

seasonality, I So related that see quarter. in we it the increase to inventory call the demand an but we weeks inventory did an did also slight saw increase saw in a wouldn’t in and increased see we in we on our increase hand.

in weeks, very range We’re still the X.X range. our lower but we’re end that of comfortable around at

real there’s And it. seasonality so, no to again,

Kennen MacKay

Thanks the and so question congrats. for you. much Got

Operator

Thank you.

Lawson Peter comes from from SunTrust Robinson question Humphrey. next Our

Your line open. is now

Peter Lawson

Thanks for taking my question.

on mostly way kind patients post the that one you the biased the driven break gross any quarter, that of way of or Just Is out mostly can or is diode? kind by there frontline this particular? for

P.J. Haley

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

I ICI It’s therapy. from of we’re early terms days seeing of think lines to any matter combinations. like therapy seeing it’s sort that patients kind cabo of it said, or of in from I across the go for on

first-line to so coming but the the are speak first-line. to still to are majority We And is ICI in patient the in think we cabo, to going quarters. we who new in get treated grow starts, seeing are of with population on that seeing continue a those patients combinations going

population. particularly there guidelines XX% the that and competing risk to TKI of NCCN favorable now which we’re intermediate the effectively makes preferred across that with poor I in patients, us groups the in and really pleased updates is frontline broadly think risk we’re We’re the September

think the TKIs. we grow in to I the the So of first-line have continue at expense other to the opportunity

Peter Lawson

P.J., do TKI mostly share in space? the you you’ve think where taken

P.J. Haley

revenue declines decline years come quarter-over-quarter. December, revenue ago those of we’ve taking decline. double-digit their you but quarter-over-quarter, Sutent a both launch we XX% if it, at the Sutent in Votrient. TKIs, it significant while our increase seen really Frankly seeing from axitinib, both CABOSUN look we’re Certainly in had sequential since saw Peter, we Votrient had and from all and

all we of think we’re So on impacting them.

Peter Lawson

just finally the to It be should SG&A got next then and opportunity. adding like kind not flat And kidney of being you and bandwidth year? going kind feel we you’re to enough think like liver on indication the liver kind – of into sounds of

Mike Morrissey

well these good effectively of But really the and need that end need in compete infrastructure, that we’re to indications, – the and that in sales included ready to the the will regard as representatives personnel I teams as put both at commercial place HCC. XXXX in to that structure shape think and do the to with in team we launch marketing adding really

get HCC. organization. to is with with to So large to commercial oncology some And we do regards there and start leverage overlap in operating expect a regards community RCC the treatment to of

RCC As mentioned be I will of upon start calling we few treaters for representative remarks, prepared HCC market a only on it the in simple currently XX% opportunity, to approval. and very of accounts potential potential cover HCC a and the those the just

Peter Lawson

Great. Thanks questions. the taking for

Operator

with from Stifel. comes next Stephen And question Willey

Your open. is line now

Stephen Willey

trials for are I-O that starting questions. guys the Thanks TKI now. taking of I guess, plethora underline to afternoon. the Good consider you

the as be needle of other to traction lenvatinib? than these a the so to about frontline the in the as its kinase CRA, some or gain your response what profile terms cabo, guess, of Just think needle in I depth is you what is about perhaps able more somehow relative think mechanism on axitinib of is And would TKIs, to thought you there for around the move order combos to move regimen? that the need and anything

Mike Morrissey

it’s Steve, Mike.

and VEGFR-targeting I’ll and just off additional needle top with the detail. and move both question kind I’m a board really that be kind as the across response is to to think very OS was and is it’s also early we I the needle inhibition? looks important equation. to that, cabo is think renal different. be go be depth it been Probably. important. an P.J. answer us releases press play out in that rates really to Obviously, well, types PFS that data has of we liver much AXL of with and other for cell – than least to on going start MET for study the that pass of rather commentary. important at going Again, an the important. line cabo, be what’s appear outside now clinically, TKI. Is anti-vascular able is simple some part to role of than Certainly, different because the Gisela different, me to which read speculate activity, move hypothesis Certainly, in Let DCR provide impact obviously and It of have designed to to to that it very certainly and long time the here. important antitumor, I of duration tested

those in double the TKI has knowledge, for go we that upon no terms the that should of where dealing at comparisons, liver single-agent backbone. the other – PFS, caveats to cabo was has rare So again, its my the versus all with those but cross single-agent relatively look molecules benefit event totality data, METEOR VEGFR-targeting with very you those other winning sorafenib activity second-line. survive done survival the real comparisons, Certainly we of with in cabo differences in besides time the based with first product molecule

of failed lots So attempts.

ideas. ideas ago it time took made obviously we long while Those So to. were the molecule us have when play, into we and a some put

we they’ve I these the momentum ICI is with we’ve pretty gotten that clinically, If you but strong. will, it that feel prove think that got now and combinations

broad renal, the really just of our first now and of to were certainly, do is mentioned So opportunities the at is looking liver Gisela’s well. lots of we’ve remarks, that the histologies in iceberg is and that play XXX tip to on a other study, options beyond it’s challenge And the there as scale, some got there.

deeply what excited early can. it’s like certainly to for forward as quickly that as as got and So days push we are and we us. we’ve We

Stephen Willey

I with some you’re between guess, tumor your kind bladder Bristol cancer Okay. that data as both with of with data with the data the is types Roche. you Bristol looks about you’re There well. Bristol and like the with doing replicating with And then, Bristol obviously renal think redundancy and that liver Roche work

kind redundancy the are types as should So one development parallel tumor tracks thinking guys of exists partner concentrated efforts these eventually think about trying between and just do in to choose how we you you to there about all on occurring

Mike Morrissey

will I terms upon lateral data, other would knowing more a factors. we upon the based we of basis in of make the investment competition based that the on think and case-by-case stand where decisions

So therapy, combinations lots to with stay to fast- the with what from factor the third filling field we activity. the the how say in ahead all combination question that a and wave all tuned the and to is that. where here a on the have vision wave line have that histology, relative other that certainly idea would we I is the and want obviously just taking of certainly make some and of the details, but is that now players a important get a don’t other those, very of partner, I the moving we’re priorities is trials combinations of second label-enabling cabo potential hope reality, we

Stephen Willey

lastly, you just choice in much the guess, post-lenvatinib I on of then lenvatinib Is setting? COSMIC-XXX data frontline have there? trial do And in how the And the if so, DTC. TKI

Gisela Schwab

and are goes I think may lenvatinib sorafenib that the being in in setting are used certainly indication differences being be an both regional setting. both this as obviously have and used and

obviously action older and in the little for post of lenvatinib cabozantinib filling that data patient in bit feeling is and another largely patients, active indication VEGFR-targeted getting. is but of the and/or We DTC mechanism is VEGFR-targeting data sorafenib have our the

Stephen Willey

Great. questions Thanks taking on congrats my quarter. and for

Operator

Goldman of Sachs. Choi Paul from comes question next Our

now is open. line Your

Paul Choi

second-line there demand for think is Thanks buildup demand will about that is first your there as congrats there the to gate, a what or And we of the DTC. if regard launch more helpful. I my side steady commercial get be of for question and curve questions terms as build the that in is as in taking guess view your expectations be quarter with would prepare you characterized a well. on you my of the

P.J. Haley

any guidance for We so certainly this Thanks P.J. Paul, to the of in terms speak want our revenues. is provide to question, don’t

not that. We’re doing

very I there mentioned I see heavy been unmet think is a it’s medical that, dynamic as those what we can need marketplace patients. for

that So put right newer I how think now. trying figure together with are really recently to all available out physicians the to therapies

meeting. medical the that see You

to into educate help really on us time ideal opportunity able be marketplace there. it’s an So that the to CABOMETYX for launch dynamic and physicians and data

So the and build leverage I positive and there. have we experience in the RCC think we’ll on momentum

we mentioned, target community in HCC likely I have have at this indicates are write prescribers more of for to market RCC written if it in point. they’ve XX% that As – that research over CABOMETYX the

prescribers good this really momentum certainly that, is with there and quarter XX% helpful So there, in sign. the a increase good

and So we patients forward to look to bringing that if when approved the by FDA.

Paul Choi

renal at us Can or your in various then, of so that any and wake that. datasets TKI least ESMO. far Okay, What you we’ve TKI about patient think I-O thanks right give or plus where thoughts are now? could And post what you relative seen you the possibly docs and how it is I-O look for color duration hearing post in headlines population? updated are thinking sequencing the to like the on

Mike Morrissey

field, renal everybody Yeah, and in really and for new exciting the have market been RCC decade certainly the a options mentioned, now I I think, patients. their think has for I to KOLs, as over sequencing a for

think see RCC. to any in early to think kind of play and us things play as we’re momentum the in and the And in lot years will currently that frankly to the we a coming little second to successful data how in the be really well more and out. there. and post of a speculate the marketplace. out the continue having in being compete the experience team bit gives see line sort really combination continue quarters really have in positioned choice TKI think we ICI great as But mentioned, And of I as to I that marketplace sequencing I I first line continue probably to until it’s beyond well

Paul Choi

Thanks Okay. for our taking questions.

Operator

you. Thank

comes Our Morgan from Hung Jeff next question for Stanley.

open. line now is Your

Jeff Hung

Yeah, thanks for BD that on taking the questions. question. A follow earlier up

right the do deal that at right to said you you the price. So want

So has feel you priced? the still attractively do that now recent on a views assets things market Or too pullback changed little are bit more might priced external your be high?

Mike Morrissey

could deals, Yeah, that for the fit. The Jeff, important. those and the to data, really be doing assets their stage again, Price in the right front stage, with early as right, the potential – of mid exist. well. – on focused science ability and useful But issue franchised think I the is data is in those assets late stage, their we’re more have our with stage, rights certainly the existing from as we whatever to either portfolio those sense other compounds preclinical makes ICI standpoint as other in the well that and compounds that combine molecules, or be around stay as on own early

priority that targets. fit as the see the a miss certainly make we The at best noticed it’s how growth well assets, upon of possible we’ve has agnostic modalities, the certainly not looking view where finding of to recently going something to the expectations the based framework our hard for longest pullback the the the to to around term that we’re science. but really sense at doesn’t real kind standpoint not – us overall is – to assets the have that, drive we the from that trigger very is in forward. very driver certainly So potential classes, have or pulling it the But has we’ll and us we

Jeff Hung

as such Great, highlighted and RCC And thanks. you’ve between prescribers. then the HCC overlaps

differences you for do prepare HCC preparing you in see And potential launch, the you for are from what As RCC? how those?

Mike Morrissey

a of it’s – indication, certainly lot differences a is different are oncology though generally. clinically. will just That commonality so there community There in

the spaces as engage be vigorously launch. TKI really and fact there’ll so will and that KOLs some in immuno-oncology is common The in and So, oncologists HCC customer clearly, too. and community academics both marketplace mentioned upon very that similar are base I

years over us of I service think types will serve – competing experience with the those our few well. really So last agents

So to I it excited have get very as certainly think the as to hopefully there opportunity we’re sell soon out possible. and

Jeff Hung

thanks. Great,

Operator

Thank you.

comes [indiscernible]. from next Your question

Your line is now open.

Unidentified Analyst

Clearly for Hi, squeezing KEYNOTE guys. XXX in. gotten excited. everyone me has Thanks

to And question I’m and try up? Is if about more interim an coming ask So Checkmate-XER. so, one when? going there

Gisela Schwab

by haven’t to really the address Remember, really say questions – we interim can this is and of the run on for at design. spoken study Yeah, BMS the and point. being about like them trial details what it’s any analysis we

Unidentified Analyst

of cabozantinib AXL lead MET have with and Interesting could Okay, hit. some to discussions with – ask. KOLs. PD-X kinases synergy be that I could had and They causing with highlighted our some It I-O the that to – other in PDL-X. and

that types than cohorts relevant at expansion slide MET synergy with AXL T does wondering more with I’m that certain that and the others? this one. you for tumor the cell put would example, in particularly Looking the be Is

P.J. Haley

through respect subset. one. take AXL to largely AXL I’ll and cell P.J. role is on this MET with The of Yeah, driven MET the PD-X immune that and is probably

it’s host rather site of kind than thing So thing. tumor type

that So, play clinical in seeing if general with cells, immune subsets. modulating totality you cell also been activated and There some in in that’s they And patients AXL. models MDSCs. ESMO you recently. is very I profile, of interesting a in kind TKI see cabozantinib of just PD that of and and Tregs MET we’ve they’re we’ve at you in help in increase is treated environment. suppressive And cells, role And decreases enhancing cabozantinib preclinical a poster a VEGFR, immune get got increasingly when at the immune what suppressive the the activated, target in role look get the T

findings one activated in natural that pre an showed – confirm cells. patients Looking at those post and the RCC on cabozantinib killer actually and also increase

ongoing the I-O So we’re provides cabozantinib. trials of it’s the scientific we and kind I for cabozantinib. think underpinnings that immune innate And the adaptive systems with of with impacting combo feel both

Unidentified Analyst

is understand advantages centers? anything you wondering On on HCC, that this to expect against even call discussed Merck community the Just Okay, going you HCC? That’s unique HCC, have could thanks. up you when larger – extensively prescribing in you I’m have you’ll RCC be I square overlap the But what today in we wondering to exciting. just the setting. in

Mike Morrissey

I that Exelixis. the have tremendous have we’ve on advantage think have frankly, positions to that had hauling in going one synergy small already them got great moving of where drug educating think is business. going we’re in that we’re sell. mentioned, – we’re as experience great the hungry, with we’re our call and many think, a story data. very I of the the those success on. incremental toward Well, I at We’ve community us continue type centers these to We’ve there what’s to a it’s got and exciting team. in though and for This nimble for all HCC HCC that And on focus we to not a not think we’re we’re I experienced customers is got docs. And RCC. that of the days great and early same to We’ve we’re specific But will have and I led HCC to really centers,

So count. on make a just focus couple to I the And that’s doable. we and that things frankly, opportunity very of really have think

Unidentified Analyst

think quite either interesting you are small And by a that I’m a or if just wondering one, data out – if any us pipeline, or tell you these you seeing of from Okay. have bit last preference? there’s biologics particular specifics days. could if just molecule then coming when about either ADCs you and to

Mike Morrissey

year, agnostic that’s tumor existing guide in. and the yeah, it’s data it’s interested the we’re biology Obviously, that people biologics certainly well. – about one Mike, The that us. small all modalities to we’ve with on to Yes, fronts and we’re talking looking completely molecules, the that we’re with about helps the done date as deals to and all both two one this is is

by potential have all itself able it’s portfolio. with be either combination in data to and about in again, So, existing drugs that franchise or our a build we to other

Unidentified Analyst

very you thank Great, guys. taking my questions much for

Gisela Schwab

course. Of

Operator

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

Susan you Ms. So Hubbard. may I the over Hubbard, will begin. turn today’s to host, call

Susan Hubbard

unable you, all calls follow-up that us get your welcome questions Justin, any thank you additional to and in to call. certainly for and Great, thank today’s joining were we you We today.

Operator

today’s conference. Ladies and concludes gentlemen, This thank you today’s program. for in participating

disconnect. have day. all great may a Everyone You

Exelixis (EXEL) 1 Nov 182018 Q3 Earnings call transcript