EXEL - Earnings call transcript Q4 2017

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis’ Fourth Quarter and Full-Year 2017 Financial Results Conference Call. My name is Sabrina, 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 results and Sabrina. the us conference you fourth Exelixis full-year thank you, joining all for call. Thank XXXX financial

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

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

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

Michael Morrissey

strong everyone for of call business. joining a all quarter to We had and fourth Susan, you, performance productive today. with the components us thanks Thank operational on across XXXX full-year our and

new to launch We us which move into developments, first-line we to in significant as CABOMETYX a commercial financial growth partnered milestones, and P.J. continue CABOMETYX. point agent checkpoint Gisela, a and updates on and business. start from inhibitors. begin in in achieve call our potential business of our in combination key XXXX finally, and our a the momentum Exelixis development cabozantinib RCC to puts to or important cabozantinib with XXXX our indications by QX either components turn our position Peter, further and balance regulatory, cash over priorities brief commercial then and as single invest our providing and with and financials, our I'll activities allowed today product to summary recent for Chris, critical in programs, sheet milestone and for revenues us for in free generate as other optimize inflection cabozantinib efforts was XXXX the

patient year-end cash revenue new net revenue XXXX Key updated on can we CABOMETYX and on include, provide CABOMETYX an commercial expanded based target for indications building disease the $XXX December. where with pivotal with came advanced plan now that of first-line the $XXX we with of received additional approximately trials. of for population product potential total in in for net RCC development through $XXX USPI goals entire cabozantinib advanced first, addressing $XXX and foundation million, XXXX performance late Specifically this in million income strong RCC, of a million, launch million, approval our the the

RCC for receiving indication over the hours significant RCC and for patients the reinforcing two prior momentum have our and received to as acquisition launch of ready as was within TKI in those this team well progress months commercial patients last untreated who previously leading has building energized and experienced, letter talented, therapies. further approval Our in made CABOMETYX

pleased are with on trends which seen in shortly. encouraging updates, directional will We IMS recently the P.J. elaborate the and Symphony weekly

key continued extensive as to a second where royalties from goal financial performance that internal U.S. product activities. will our new milestones for revenues resulting our from as partnering seek plans cabozantinib we free the well is and to assets us The partners from cash our sales for platform and and provide grow into reinvest development

trials for Third, to additional initiate we look indications. new stage late cabozantinib

resulted MTC, checkpoint the agent the With wave for data for trial second-line of trials HCC. now in additional and second the we of therapy. now wide CELESTIAL first of improved indications well from stage in late on ready to and inhibitor across and HCC, flows, success the combinations as RCC, completed data and wave With positive single potential began XXXX pivotal that both embark a are range cash of and as cabozantinib cabozantinib histologies trials lines of we

of the and as investigating entire is that's fourth IMblazeXXX, field looking and of Genentech focused data immuno-oncology a in as the crucial for partner novel pivotal of to well cold tumors to guided half immunotherapies. obviously the for CRC, is the of our to Our the place trial readout in take XXXX XXXX. first sensitivity mechanisms readout This atezolizumab cobimetinib the increase franchise completion key on which combination has third-line cobimetinib the goal

development to rebuilding Finally, our externally focused fifth pipeline our focused business internal is and activities. discovery on goal

We a keep molecules from [indiscernible] that range have moving external several to opportunities the to the of under discovery deal oncology wraps full time biologics. plate small cover and projects being will for that

of announced XXXX with financial, commercial, in A more XXXX details corporate We expect we as we early the a regulatory in throughout business. and of milestones XXXX achieving transactions performance strong components to complete see will reflection important additional deals. in significant momentum development, our we and those provide as

our the free all rigorous efforts a Gisela, revenue generate who for sustainably overview tactical manage sheet, and will balance our plan Our to XXXX part which with sense an multiple XXXX. that, expenses streams our since provide on significant embark call right fashion depth I'll in to cash to in were of business, breadth of efforts. our our in over and will cabozantinib development reinvest turn With

Gisela Schwab

to inhibitors you, to including supplemental BMS provide respectively. I’m the cabozantinib, with on program I’ll RCC We've the in lifecycle second-line file collaboration progress in on the remain regulatory for significant NDA HCC and cabozantinib with management development the progress and Thank today of HCC development and time plan quarter. Genentech-Roche. immune first-line advance the quarter. pleased on first and with later update for our clinical my made Mike. a for We an spend checkpoint in combination work tract broader

is activity therapy. of and as of primary BMS, the nivolumab alone, of progress including the about objective safety trial is II an and enrolling rapidly. immune XXX with This nivolumab PFS. or with combinations a This cabozantinib I'll important combining and cabozantinib, is We safety of Phase run are CheckMate in checkpoint combinations secondary HCC patients of and objectives combination study objective response part pleased the cabozantinib, and include evaluation HCC cobazantinib collaboration trial development front-line further inhibitors the the clinical as the with think with the and both is in rate The in ipilimumab HCC. and the ipilimumab. of start we nivolumab evaluating nivolumab with our advance trial, preliminary discussion

follow cohorts Turning of a Genitourinary presented millilgram/kilogram or dose in recommended ago trial XX for a patients. for for milligrams Phase three evaluating a the the triplet urothelial as place range previously included to the with and including patients Cancers This for patients median with few San of on that evaluation. XX.X established has recent Cancers. and valuable years and valuable previously cancer start patients stores nivolumab for took evaluation Cancer were National update treated Ib the on triplet administrations months ipilimumab ipilimumab, a of with four the follow-up now the XX Genitourinary doublet, expansion the cancer patients and The conference, nivolumab response. cabozantinib to the response of and Cancer XX milligrams/kilogram with indication, with cabozantinib, Francisco the metastatic the metastatic trial treated of for an the urothelial from RCC the addition previously ASCO for at doses and those for and as both cabozantinib, RCC combined doses one trial nivolumab doublet Genitourinary and treated with combinations for Institute

of nivolumab, results objective combined at rate original complete urothelial at For inform be importantly the urothelial combination XX% Among three X% with patient this one and in patients was trial Genitourinary off. overall response the is progressed in who the XX.X one and and cabozantinib the the the metastatic compared now with was and cabozantinib, diseases and including Median The controlling therapy, Cancers patients RCC, checkpoint was to These cancer rate called six response to progression-free two and respond, XX protocol metastatic disease a of response sunitinib. urothelial first-line evaluating arms encouraging cancers. cut for Seven to RCC sunitinib. months data and the inhibition have patients Phase valuable XX% cohorts were months was stable responses the time not the cabozantinib, and or and survival and including are control RCC a eight partial And cancer to population study with III XX%. and ipilimumab XX survival of PR including disease of one, was nivolumab required randomized CheckMate and rate the metastatic objective XXX%. XX%. to XER to future one ongoing studies CR, XX%, response our

sunitinib survival to with nivolumab collaboration Ib Genentech/Roche is with evaluation. tolerability evaluating cabozantinib atezolizumab with recommended are is milligrams off with advanced overall the planned and patients cancer cisplatinum-eligible secondary tumor patients be treated CheckMate The all with the risk in XX-milligram advanced XX the the RCC, triplet the different advanced untreated previously two we dose and nivolumab bladder ranging Furthermore, the daily separate patients. of amended primary the a bladder to the RCC weeks dose combination III for in a However, ineligible and randomized metastatic prostate in cancer groups. an combination involve untreated cancer combination. of lung monotherapy trial the approximately as following cell previously positive atezolizumab ongoing with cabozantinib the triplet accelerate previously non-small inhibitor and patients receive with XXX to cancer, with malignancies, the modified previously this evaluated evaluating and combination, estimate in experience one-to-one development settings, the investigating under Patients and The of combination daily the remove protocol RCC naive trial patients trial trial study. it's free XXX various combination checkpoint have or XER III survival. endpoint lung being with and including both sunitinib study patients schedule. on ipilimumab cabozantinib XXX four-week every checkpoint was initial Phase including been bladder untreated cancer of of trial and patients trial, and the expansions continues well non-small as for to previously cancer added nivolumab our versus genitourinary on, Phase test Phase inhibitor of triplet castration-resistant untreated milligrams to for with patients progress safety an and results of protocol Further to established nivolumab mentioned cohort early The effort cohorts, in and metastatic two-week CheckMate BMS’s and combined progression endpoint cell aims and and or versus

partners, the have each indications now have Ipsen Further in per and day are recommended future as will participate Takeda, part to begin trials enrollment terms dose studies three combined milligrams cohorts XX both expansion milligrams weeks of respective in the will collaboration cabozantinib shortly. of the every atezolizumab under the accordance trial with combination their X,XXX We our discussion with additional the in opportunity and dose-ranging agreements. in and identified

time. forward We start at are trials XXXX We pivotal the are and for details and trials planning in this with atezolizumab look next sharing to studies working appropriate designs to and the time. such additional at on on XXXX cabozantinib study specific

our III shown cancer cabozantinib trials endometrial types, actively And efforts, and and studies immune and program Phase preparation variety NCI-CTEP and there tumor in with through various are in multiple cabozantinib advancing Phase addition indications, and cancer, of In tumor combining now clinical has single breast partner review And study types. from concepts including triple-negative patients. in internal are and cell of to with including our a enrolling evaluation. under several investigator-sponsored cancer neuroendocrine lastly, lung both activity Phase tumors also nivolumab and PNET of thyroid combining other differentiated indications which are agent cancer, inhibitors II encouraging checkpoint trials carcinoid II non-small at trial cabozantinib

So program with And and that, progress to over milestones cabozantinib look made will in call in important with the our in forward I'm future. quarter. the With during pleased turn you summary, the the very to this I reached development Peter. updating

Peter Lamb

that includes has Thanks, expected third to with and by XXXX, Gisela. previously quarter in in earlier read vemurafenib in multiple previously the first is III ongoing The locally currently metastatic With is BRAF wild-type advance, Most in the of this XX quarter. also trial combination that is advanced or collaboration combination to trials initiated TRILOGY now quarter different program IMspireXXX an with types. atezolizumab Roche first Sankyo combining a Daiichi three XXXX. enrolled studies with development sponsoring carcinoma, IMspireXXX cobimetinib of CS-XXXX tumor Daiichi of year. cobimetinib the the in Japan Sankyo the untreated their now mutation-positive joined of The confirmed which this stage is BRAF melanoma additional untreated in from half in selective of progress, Phase cobimetinib in esaxerenone, the and track during to trial, own metastatic which The cobimetinib receptor mineralocorticoid the clinical is studying out atezolizumab colorectal Phase third-line NDA research IMblazeXXX includes or and III identified atezolizumab in file clinical last respect trial fourth potent melanoma. trials. the year fully

the announced Sankyo XX given who that the third There significant Japan have treatment Sankyo a topline Phase this into are million for registrational Daiichi advanced there quarter positive the in effective is agents of quarter approximately with Japanese Daiichi in in year, previously CS-XXXX we As patients trial hypertension essential III discussed, third in blood last data from the hypertension of high of the pressure. essential adults In new trial. have XXXX. need

quarter our four the nephropathy In Phase of off pipeline quick molecule they diabetic in expand addition, some initial at an trial active Phase in further development internal conducted move internal this active second initiated later trial at III the groups which discovery this with finish identifying these in We efforts process, update patient encompass now have capabilities feed business And new rebuilding I’ll reestablishment pipeline. and oncology of aimed chemistry builds to once development the with our program and Exelixis. on population. year, could will our biology we advancing small labs that a into or efforts both Japanese patients efforts, IIb discovery last which our now meet previously the year.

believe January, Wnt tumor On we carcinoma, novel have our compounds collaboration the inhibiting colorectal approaches advance the in that focusing class the with genetic previous to pathway tumors. Wnt the We by of tumors The could first mutations inhibition normal front, have over signaling. over year inhibit where most sparing in pathway pathway CKXα that prominently while in approach tissues. BD announced pathway Activator Wnt many this Wnt results of including in XX% use of StemSynergy in advanced loss activated pathway types Wnt activation of APC to

I’ll Finally, now we and currently at call JPMorgan strategy turn with further fit Chris. one the our week in the multiple going over had busy Conference January, the a process to evaluating the forward. in best opportunities of reviewing the are

Christopher Senner

GAAP the $X.XX and fourth quarter-over-quarter share of XXXX per earnings to quarter GAAP $X.XX basic of revenue with for Thanks earnings million Peter. or wholesaler of share continued driven in of P&L. by income the quarter $X.XX the and one-week an XX% Total of sequentially. year-over-year in was was RCC reduction GAAP total in in offset a revenue due of with of revenue revenue net a advanced an was built change for the The The $XX.X per approximately inventory per impacted million share by $XXX.X decline compared for was million, decline diluted of earnings Genentech’s of the primarily setting. demand third year. positively X% year-over-year product share $XX.X quarter collaboration later quarter per to to the increase sequential the uptick XXXX last COTELLIC X% respectively CABOMETYX Product by diluted diluted The cost period in result were the net XXXX. and fourth $XX.X allocation million of commercial same increase second-line increase overall U.S. and

co-pay year. includes with many million that quarter calendar Additionally, we program. whom the includes $XX.X more start sales quarter with wholesaler dispensed $XX ending revenue. revenue related $XX.X a XXXX, ROR patients from an inventory million patients, gross earned to and Takeda, to hole the during will and revenue year as frequently filings also Total that This in to IND from Medicare the increase experienced first revenue in well gamma our utilized deductions for enter of also from Genentech. milestone will the agreements of assistance as our doughnut BMS related collaboration collaboration commercial collaboration the of Ipsen, million program of a Total revenue be includes

outside million and and for the profitability. the operating Genentech in turning diluted in the period period $X.X related compared in basic organization. of increase driven result in the personal and XXXX general administrative of expenses share expenses, a With continued consulting quarter XXXX was $XX.X income period expense as million with our development million a long-term increase XX, XXXX. period for of driven and $XX.X to collaboration comparable Fully for investments an million were million in for and trial was an $X.XX to growth of compared to our under were Selling, for the services. share the million, Now million, at an increase and the XXXX. for primarily was for quarter by and administrative activities diluted for and we as in $XXX.X to the million selling, December general, net allocation was revenue our resulting impacted million period $XXX.X approach expenses reflected increase compared and million of services, which the agreement and operating expenses revenues, XXXX or share primarily total primarily growth XXXX. period was diluted, activities. $XX.X net full-year in for the Genentech, per December comparable at in expense losses increased agreement comparable decline $XXX.X comparable in XX, in the million clinical and compared to XXXX. XX% expenses, increase December Net in expenses increase to $XX.X in totaled compared the Other to were $X.XX costs, Highlights same ending the for XXXX. XXXX. year-on-year the or primarily income Marketing the and loss this the which Research operating million $XX.X comparable and for and in was costs, expenses, approximately development comparable an personnel by increase in the The income was The The million, result elimination of clinical ended comparable investments income net achieved the from million XX, XXXX increase in administrative $XXX.X Genentech expenses earnings the expenses period year comparable XX, increase expenses compared to was the operating compared primarily The $XX.X XXX% XXXX, the the to and income and year of in $XXX cash was to cash trial outside period XXXX. XXXX the and quarter operating under by cost and debt. partnerships personal in approximately of $XXX.X quarter to and The quarter partially the December in a the million XXXX. XXXX expenses, long-term positively million for same support short ended the million marketing year in product of full-year consulting $X.X primarily receipt management December in in XXXX. and short and million compared a loss in $XXX.X include for This December in XXXX quarter the in due of income equivalents, for and offset collaboration to restricted headcount Cash, research Takeda XX, Total fiscal XXXX. revenue by the upfront year payment total period was operating the grew income were net $XX losses Exelixis in for milestones for the the increased $XX.X cash to for broader period $XXX.X the over were per expense expenses. increases general increase million change with share per of by compared offset Net the for of and total XX, revenues $XXX other $X.XX to end at XXXX. in from $X.XX from revenue increase compared XXXX. strong net increases per of ended full-year $X.XX existing net basic

color discovery, The turning and our P.J. need launch I first-line incremental more turn revenue is projected provide is operation increased cabozantinib continued plan. will $XXX The the million to for performance. $XXX now for XXXX over second-line increase keeping CABOMETYX with for to several launch. due will call investments full-year between that, total and repair at operating we RCC, HCC including in to total trials, With providing investments the our and our and to best investment clinical our on be factors, commercial guidance million. XXXX, Company Now guidance to XXXX in this providing practice, the expenses guidance the will be and expenses not

P.J. Haley

Thank you, Chris.

QX. metrics label encouraging of were commercial renal first-line and with key the We carcinoma. based get XX in across on are in broad level cell quarter the expansion December the a you'll CABOMETYX CABOSUN, pleased The on advanced performance

on product day prepared was demand for relative more patient the in Demand in evident which fully momentarily. and share, population segments on on grew CABOMETYX the RCC increases by refills color launch first-line the of fourth to In expansion quarter approximately approximately XX,XXX began U.S. CABOMETYX QX. the promoting increases provide by prescriber and was patient market. team growth approval patients. for the by and immediately of continued in therapy CABOMETYX driven of Our study, I'll X% academic and the customer for eligible was in market both community the already base. Demand growth the the

setting New approximately plus patient grew in second-line share market to XX%. the

As provided along base now demand first-line basket the December. in setting, trend for moving driven as RCC community This CABOMETYX predominantly XX% comparison first-line the market of QX, best into launch on growth proved grew by will the focus with by the we the QX entire over at momentum strong Prescriber adoption. relative forward. we are to headed in end

The first-line first-line enables increasing continue in oncologists both disease. treat pool growth the prescriber adoption and of patient more terms patients us with eligible our to approval as community increasing

efforts to make therapy expanded of kidney cancer. TKI patients very the category. U.S. pleased now is choice received CABOMETYX, regardless in in the our in This clinical positions CABOMETYX to continue advanced of line we strongly label all are of indication risk RCC broad the We approved with as or us for

There to in prepared CABOMETYX the sales begin expanded to receipt leverage ready advance our in that both efficiently personal tireless to like representatives patient for our Exelixis prepare hit will and access of has to the customers. knowledge synergies thank FDA immediately PDUFA team the prepared the was to upon ensure months help non-personal date. for the holidays launch eligible XX, ground on indication launched approval fully many to to I team first-line of our would RCC every Many running well As and marketplace settings. our first-line we first-line educate to of I the efforts their December on in and entire CABOMETYX. the of as over and almost two promotion of mentioned, are accelerate RCC. the in physicians launch

For lines, of which RCC has example, later second prescribing the prescriber prescribers in setting. with the our relationships. base team first-line same help these adoption as facilitate have already a RCC CABOMETYX, new base as or established The which for a should first-line experienced majority

is and the a still had strong survival, early similar of anecdotal The timing launch, various standard superiority across months by Sutent free beneficial functions two at conference. while demonstrating safety from engaged in the the CABOSUN meeting profile. of the within of the of our presence research, our Exelixis a KOLs coming Symposium was initial recent in market ASCO-GU and of Prescribers are terms approval. at in a many the customers that While top care our it long-time data, progression feedback encouraging. RCC first-line data statistical to motivated are shows

the hear KOLs importantly both meetings in from to pleased on meeting. are the the We from first-line and feedback more in the throughout our settings CABOMETYX positive one-on-one of context podium

look increase IMS for the The a signs data leading CABOMETYX XX seeing we an systemic prescriber on a at the the QX of patients the deaths period cancer potential only accelerated year therapy. for accounting since XX,XXX of basis. clinical unique data. liver potential therapies of marketplace. carcinoma by approximately the new I common mechanism approximately that in going under in In Sutent, TKIs cancer addition to encouraging year. its four tumor a early that indicator are doubled to-date period CABOMETYX, Historically, near-term. is Inlyta, clinical over and and the CABOMETYX has said, diagnosed a trend Sutent approximately QX annual Ipi/Nivo one the XX% a years would are of still is CABOMETYX. QX. six The believe community the of clinical the impact of the was with is week In recently long market fourth first-line [indiscernible] data and franchise represent are approval the period, basket as approximately is accounting We In oncologists addition accounted CABOMETYX the by future. relative interesting the these new growth Hepatocellular already are need growth trends XX%. the liver TRx has on the U.S., grew cancer label new type there prescribers. XXX,XXX volume driving most CABOMETYX shown an data but Votrient market. the on the introduced. in get action. refills until to top HCC, for The That written in globally of relative prescription Furthermore, form have points of for representing broad CABOMETYX presented the of writers and weeks which RCC one now strong of the data competition for potentially with data indications and in beginning of prescriptions this launch. approved These HCC, Votrient early forward to primary RCC data first-line cabozantinib will XX% first-line in terms a label the and will and coming market recognized year of will market coming QX six and approval has CABOMETYX from to based likely well days six a first the as HCC since nearly are share. looking as Also, We market position a cancer. This has data, the prescribing have same RCC cases TRx for meaningful liver and it increasing served share the turn fiercely positive Sutent differentiated in cancer, grew first-line suggest trends launch. deaths each there of December adoption approval. addition anticipate the with we U.S. and to has to are continued which have the that well briefly in in thyroid XX% and market year, feedback early pending weeks competitive to totality CABOMETYX become number is early for prescribing FDA is further some we the significant of RCC first to XX,XXX anti-angiogenic grow that by first-line bladder of this caveat and CABOSUN prescriptions differentiated syndicated both majority This through unmet third Votrient top the medical in approximately the of CABOMETYX insights. been XX% been followed the and in new yield indication of in This cabozantinib In to-date the

requirements you from them are regulatory and these near-term As to our potential Gisela, heard potential opportunities as the commercial and clinical assuming we look indications of brand, growth at are development plans satisfied. for new forefront the

the set potential TKI well. about We the future, cancer, the standard could our second-line checkpoint plus and potential are excited with as choice establish is combinations long-term for our future inhibitors franchise. differentiated and where thyroid go-to-TKI settings cabo offer bladder cabozantinib to RCC, of has like mission CABOMETYX cancer, as the is CABOMETYX opportunities in indications of and

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

Michael Morrissey

saying move commercial, and provides of assets. into our significant we made position foundation aspects and and strengthens we we internal R&D performance explore Thanks of organization external financial, licensing efforts strong for important P.J. across I’ll the as of continue see all to XXXX the by close regulatory trials that QX rebuild and solid XXXX. our into Recent in in progress indications in right. clinical, through and All opportunities to progress as our new pipeline cabozantinib wave a business next

We I’m and part are to longer. urgency with stronger be therapies Exelixis recover new at on work mission focus cancer. team a patients of as help proud we with cancer, with to to live deliver to patients and our

look year for We our remain day help with as don't our take good making in a us. mission patients was to cancer. count steadfast and to success granted, XXXX Our we fulfill for every

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

call happy now We’re open to questions. the for

Operator

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

Eric Schmidt

talk Thank that in you guess you that into impact on gross deeper QX that the and October for Maybe saw, I trends. the so curious price to net inventory Chris bit updates my of and question. as the cabo sales Can well? maybe face you for I'm and happened little taking could just get quantify to you decline the about the as increase, in why an a

Christopher Senner

Chris. Eric thanks. It’s Yes.

prepared my did demand quarter-over-quarter. did out quarter. that of the we X% the quarter third of channel see came grow And on by the during said remarks, the inventory I as one-week So about our versus

net at particularly quarter. did the gross end the gross we at looking net, Now of higher have to to

trade the that co-pay as typically of I year beginning we as that see with assistance top beginning As that We the the on and the On CABOMETYX. comes to many that, as our from we side do looked of hole the in would or through facts potentially mentioned, deductibles flow from about year. the of commercial going coming talked there the at evaluated insurance the side that against patients would at new people’s higher calendar the reset the their of business we recognize through. doughnut and inventory we looked be and Medicare be that the patient

elements I really are the think in that driving change those revenue are quarter-over-quarter. the

Eric Schmidt

that Medicare I how good, Sounds but QX? does impact effects, QX the understand

Michael Morrissey

in obviously effect product have is we the the well, trade. be Well, that patient a denumerable because if in will will you – sold trade, already to that that inventory in have inventory

to So revenue that. effects we our for have

Eric Schmidt

Gotcha.

Thank it. Okay, you. got

Michael Morrissey

that So [putdenumerable] in the systems. co-pay

Eric Schmidt

it, mean Got then in time? Do are over that you price flow you through you increase thanks. think will that took general? And I the on

Michael Morrissey

vast is way pricing the typically through our flows Yes, still mean with does that of the I it majority flow through, I mean right now launch. from

can of most flow through. to expect So you that

Eric Schmidt

same pretty last similar other? ratio and the or is the side, both maybe the XXXX R&D magnitude and of on such good seeing think you're One we the as at more to expense of one XXXX one Thanks. the in by ramp, looking should increasing, impact SG&A quick on a

Michael Morrissey

mean No, discovery as Pete is are continuing ramp both in the we investing and heard – I and Peter, up efforts. you cabozantinib, on from the heavily Gisela continued side then to indication

side. going I’d than SG&A that So the the faster say R&D to is increase

then extent will the on the that side So year-over-year lesser on increase see will SG&A side. the R&D and be the majority of too the

Eric Schmidt

you. Thank

Operator

Thank comes And Andy you. the from the next line Blair. Hsieh question of with William

is now line open. Your

Andy Hsieh

here. thank my just Hi, question on for you taking and congrats marvelous

there? Phase seen upcoming IMblaze So up setting So the as could represented it you being the diseases I've or with trial, second-line/third-line third-line? clarify those III

Michael Morrissey

Yes. Peter, go ahead.

Peter Lamb

Yes, patients lines the so received and two trial to eligible are if they given trial the on we for come chemotherapy. who patients received trial of But chemotherapy.

then So further one second-line. they and be would speaking, then would given line technically strictly chemotherapy of have

difference So that’s why okay. you've seen between the

Andy Hsieh

I-O primary arm Got more refractory, as a it. believe ORR recently may. follow-up urothelial a And in then initiated I single endpoint I if carcinoma. Seattle study, pivotal one

similar terms Roche, in how you in is use running of much and you. I-O this refractory trial So about do population? FDA since think the with design you we the talking through with Thank a can the amendment

Gisela Schwab

include describing cancer the so earlier cohorts. inhibitor checkpoint patient Phase experience non-small and evaluation and described both represents it’s and plus the bladder population included the of expansion Ib population, I that it lung cabozantinib study for in of cell as you one So instance ongoing – the atezolizumab cancer

patients I inhibitors. it's whether beverage checkpoint immune-permissive certainly you question an environment address that to judge to can think to more cabozantinib have So examines creating interesting a recent

Andy Hsieh

thank Great, you.

Operator

the from question SunTrust. of next line Thank you. Peter comes with And Lawson

Your open. line is now

Peter Lawson

that effects net value the to it possible going gross kind the of is inventory, wholesale that higher place a for effects for normal? that on on just you to Hey, and going to the net that does back gross – Chris, and higher on the new quarter, forward, breakdown dollar of remain to is just

Christopher Senner

thanks. It’s Peter. so Yes, Chris,

way. specific XX.XX XX.XX can We're answer would QX. both higher see I to one gross at inventory or – reduction impact the that to the provide from the So guidance of on QX – gross of the also to was what’s this and you going not

So your feature at range XXXX, gross the you can a be question do also can I we as near the XXXX. think in in look don’t about that. on holds? math this of look your will normal, future of Is what net you XXXX kind that to But

Peter Lawson

you feel guidance? confidence providing provide the revenue just Thank to able Gotcha. got then outlook you. to you’ve And thoughts what or around point guidance of be

Christopher Senner

Yes.

that front-line HCC for from and lot and there, RCC, the guess are view, a review that. I point new guidance So variables quarter filing then potential are there this therapies of including revenue our out of period a in

the the the can of those As we at do that and we feel of didn't we symphony look do monthly data that look IMS or know.. and – comfortable or that comes with through we when trend way, weekly at you at feel time. providing variables, you a comfortable this at we will it and But range always quarterly way look on let is, a basis

Peter Lawson

IO as IO as of that second-line and regained impact you be you're impact the move in on question the for of any you and – to guess impact just then just – I Mike, think if that And you could Gotcha. front-line? share, seeing moves market

Michael Morrissey

his terms about the remarks, I plus think we prepared not setting. bit P.J. in has market if of little in share second-line of stable see talked in growth

in So able help the obviously looking patient level we're we've every now literally RCC focused every be to on day to eligible got. that the space with

of we newer literally again hit about previously pivot data as is I we a be that we out effectively, come if So so certainly totality now What a it great as and needed upon with broader able then on IO on we'll level holistic really team think eligible we combos we're approved where change motivated. going as now, then that is the guess could at every and to you to compete think talked time at, continue of can patient much the focus in where regard and and data to hard. some but right based it get over now look right extremely – to

Peter Lawson

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

Operator

with from comes line question of next the Kennen the And you. Thank MacKay RBC.

open. now is line Your

Kennen MacKay

on Hey, in taking team front-line NCC my questions. offer addition for Maybe guideline the RCC. thanks and to the while congrats wanted for P.J., whole and my

the week still the increases. to was And the you’re front-line again from cabo on are wanted thought would were market of front-line, sales impactful pretty some – even was from see thinking addition prescribing wanted with see that to for those and preferred RCC of getting atezo cabo Wanted you then that population XX% the ordinarily up Sutent same year? physicians and given to point was quarter-over-quarter your preferred how combos wind that there? you cabo with competing the and about in Ipi/nivo and Votrient with are you front-line you. of do from coming this the two NCC clear presented additionally patient that perspective ISM Thank – in when to guidelines the see that what patients if agents with share And carving – be those hopefully

P.J. Haley

the address start I'll Great. kind Well that with that out. of the thanks Kennen. order you for question, it to laid

I’ll And Sutent prescriber doubling A talked an of writing approximately in that metrics. market. as the in they're market also prepared to on as cabo as we acceleration other reaffirmed First a prescription the growth share that we're same TKIs about TRx, relative you as to mentioned our of on terms regards all looking quarter-over-quarter at in and period well. top certainly of we're we prescriber to call, couple just increase and with volume pleased already growth we're other it in remarks of period XX% the spoke seeing amount quarter-over-quarter prescribers the adoption, a terms time data, we're that in of what the our of the seeing we're points in seeing seeing Votrient the the seeing in and with XX%

we're down prepared a broad telling clear, place that. aren’t combination going if That very I were regard in our as has the physicians is mentioned launch always very from competent first-line. there be great it's of I on in well therapy for we're Mike very And subgroups and patients. the well all about just as first-line the impactful other the thing We're by is be said, using in remarks, it’s thrilled that market that's I of is look data that nivo very both first-line, and we with further subsequently as to in happy the anecdotal think patient when data second-line we're us feel in that – share a good that to subgroups, and And label receive in to are patient. setting as research which are market after as in our we're NCC CABOMETYX we pleased we're compelling great feel to in first-line, that. those the then is the plan that kind from so physicians the to it's certainly feedback a really from research impactful, received checkpoint data With monotherapy if guidelines getting were TKI inhibitor hearing, physicians. So all know the much being that so will coming, and as competition, together well are have mentioned road we feedback a hearing be at the the three for the what coming usage taking

eligible every label, feel as data patient. are great this broad So for sort competing of have we good very that of suite we RCC, and across such

Kennen MacKay

mentioned and you sutent you an Gotcha. And right competing cabo of intermediate in see the votrient now? cabo that risk, sort versus does where guidelines really for that

Peter Lamb

VDR different Yes. data our certainly of benefit we showing broad basically risk there. including patients label the say totality a the have, that similarly and patients significant all I in the statistically covers guess, clinical with favorable the I’d study, a with

received. those and customers compelling that think for really I hearing that competing we're we're data feedback messages, and all well are patients those from being

formidably we are those patients doing going and So we're like extremely we after think competing all that. I in said

Kennen MacKay

Gotcha. Thanks Peter.

Operator

question And you. with next of Thank from line Stifel. come the will Willey Stephen the

open. is now line Your

Stephen Willey

prior patient in on great uptick for statuses I seeing seeing around are can not across comment or Thanks and you afternoon. any the of all follow whether pour just risk uptick question. just or occurring a just questions year. kind congrats the in on the guess, Good risk preferential make that's you’re Yes. to intermediate taking the patients? If you first-line

P.J. Haley

Stephen. Sure Yes. is I’ll take This that. P.J.

there, of but are that, populations. what specific on won’t to uptick sort patient we say go seeing various So the I’ll I of across any numbers

different patients. groups sort As of terms mentioned, we're of competing I across and CABOMETYX totality for in for clinical patients there's the all those of evidence risk data of

really So is our received. data being well

drug, anti-angiogenic this plus you at an look for TKI AXL. of the inhibitor is type MET, If with biological this rationale

they really to regards and many efficacy, their that are about – sutent superior of sutent CABOMETYX that think make to of improved with choices at willing sort votrient them efficacy or the resonates I customers then think with current extrapolation in and are as cases. look to relative the

Stephen Willey

then and with I And bladder with guess cancer. respect just to collaboration Bristol Okay. ongoing the

something perhaps that kind hear year? respect Just if before with in of of this advanced curious we program the expect should to more to moving end forward studies the

Gisela Schwab

certainly And Gisela. indication. that observations saying is cancer based the This I’m in Yes. study that upon the Phase made Bladder the is an interesting Ib wrote is Apolo [Andrea in rate, recently impressive XX% durable long ASCO-GU, have previously data] cancer response been in survival. in urothelial in where long response seen presented a most patients and rates progression-free treated responses and

time. we’ll that appropriate at we’re we indications various about certainly on progress it an make So announce the is education and interesting thinking it and as

Stephen Willey

just sounds the contemplating just hearing differentiated kind like pursuing disclosure some then comments second-line Mike initial on strategy. think And lastly of I of Okay. you're thyroid, a your maybe since

do still might Just [indiscernible] of seemingly is you to whereby sorafenib Thanks. suggest hurdle post what something perhaps still like a there as you the cabo would a there strategy guys? maybe for compare curious would cells fairly any be responsive tumor represent contemplation guess low which guess and would and I a you have that front-line that evidence perhaps it pursuing I also

Michael Morrissey

Yes, sure.

looks that the yes, both first-line encouraging. So and we've had now in data topline the second-line

success the of like. could There for looking obviously second-line look at all have what options and here of those we terms in I first-line options. and of think lots versus are metrics considering cons different pros going

on tuned that. stay So

certainly agent combination indication checkpoint base kind this priorities of cabozantinib and opportunity the in to really along others either inhibitor. it's one across with tumor in year, our think the or single idea, I that higher of reinforced a this the expand to for engage want types reinforce idea with as we

So all AXL MET inhibiting again background other I these of different VEGF in apply and provide data, and well DTC will as the as could to trials, pharmacology certainly tumors. as more we of simultaneously kinds terms and roll biology

to we’re moving certainly So forward. a excited about of data encouraging the us to profile now the coming early looks put upon together and it’s plan

Stephen Willey

right, All the taking thanks for questions.

Operator

And you. with Schmidt line question the from Michael Leerink will Partners. the of come next Thank

is line Your open. now

Michael Schmidt

Hey, inhibitors either that guys. it questions late. may in about year? disclosure how I combination should CABOMETYX joined and from data with for missed new ongoing additional Thanks have taking therapy single be I studies But the as my or this agent think we PD-X

Gisela Schwab

lots Head there and the a there data Gisela. including for study Yes. the conference, for But the you just was update investigator-sponsored came studies, IST Cancers as trials certainly experience come. and importantly become announce Neck and study BMS. that communicate more question. the or maturing, trials are that This DTC advancing certainly available, pretty of thank so collaboration recent and are in year out of we've you combination and we and Certainly of Since [CTEP] sponsored cabozantinib and obviously as at recently to presented ongoing our will done that number in also and with early of is are internally the

Michael Schmidt

Okay. the on Great. and congrats Thanks progress in XXXX.

Gisela Schwab

Mike. you, Thank Great.

Operator

the from the next [Operator Peters Deutsche Thank Instructions] will with And come question of Bank. Andrew you. line

is Your line now open.

Andrew Peters

first on for guess with the last is taking question a follow-up congrats XXXX. one. Thanks Hi. strong my a and I one

specific as involvement And how studies? make data will need expansion those the out, you data cohorts that you into much about the Is partners decisions, studies? cabo for therapies with think begin from some about in your before the combination especially atezo decide read are of that As move looking there a ongoing. you are profile stage to the you and to to thinking later

Gisela Schwab

Thank you. Yes. That’s question. an important

I that forward decisions benefit the overall then strength and in of in into is in support to will you need stage certainly to the the upon strong obviously of to you go it and pull data trigger be to if data less absorbed data dependent risk so think But the development. the look future. benefit updating at set identifier point that will the is quite lots that forward late this

Andrew Peters

a then quick And just Great. follow-up.

to to understand the duration extent track is or you think are RCC, duration now anecdotal of have or more to anything there opportunity the subset As cabo the that what checkpoint they you able or after and in you about patients inhibitor media receive you. from that the right data broadly on any like of of different if response Thank patients therapy that smaller study? is from

Gisela Schwab

observation this higher Italy, it M.D. population in was and response PSS patient study but Yes, to will showed media seen with prevented the that the conferences for to that reason that been has not patient. first Europe, has we France media. the from where it been in also in and pretreated striking came as in line CPI the at statistic has small, if was duration out media move are time aggregate additional been observed quite data around trial there very made similar ASCO-GU but the what The Anderson benefit of also rates that update support

Andrew Peters

the on congrats and you progress. thank Great, again

Gisela Schwab

Q&A Andrew. you, of End Thank

Operator

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

I Hubbard. will And Susan over turn host Hubbard. so todays Ms. call the to

Susan Hubbard

on for you that And able address may certainly today’s us We any Thank welcome we follow-up thanks learn today. calls your with call. to Sabrina. all additional you, have joining questions

Operator

on conclude This and gentlemen, conference. today's Ladies does thank your participation for program. your you

have all great day. a may You disconnect. Everyone

Exelixis (EXEL) 26 Feb 182017 Q4 Earnings call transcript