EXEL - Earnings call transcript Q2 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis' Second Quarter 2018 Financial Results Conference Call. My name is Andrew, and I'll be your operator for today.

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

Susan Hubbard

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

me ended Medical Chief commercial events. are, CEO; development call of corporate, key Commercial; our June on Lamb, the progress financial, our quarter XX, recent Schwab, Officer, President corporate second well together Joining join us and our will Gisela Scientific President with our Chief Senior development 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,

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

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

Michael Morrissey

second everyone to to the across Susan, maintained and and and today. Thank Exelixis commercial right. for of thanks strong all our call the on continues joining All business. you, quarter in XXXX us of performance components execute financial

growth development of key CABOMETYX the Achievement cabozantinib revenue $X.XX our to for we revenue approximately providing and in revenues to new net cabozantinib $XXX the in significant million increased potential primarily details of advanced second CABOMETYX additional to per of in in were especially Importantly, million. commercial either indications milestone leading RCC. of advance, or by quarter share. territories. advancing Total EU Ipsen look the for then summary broadly checkpoint strong additional competition QX today single for as in cabozantinib RCC net on for quarter with healthy XX% highlights commercial the and million income business in into include, in and $XXX the growth the performance were the the royalty first, financials, for combination cabozantinib I'll XX% performance based franchise agent QX our inhibitors. on the turn for diluted and provided QX sales resulted key CABOMETYX the to see a to of $XX.X immune in begin Key context of revenues tiered call earnings rate P.J. milestone XXXX milestones brief commercial and activities. Gisela our Chris over our and for a

therapy. of for of and cabozantinib with at in and wide lines second on in and we're to potential wave range sNDA single-agent of checkpoint cabozantinib histologies The continue HCC emerging was the and data the January filing XXXX. a for solid the regulatory expected CELESTIAL activities. May trial advance development With date PDUFA for second a indications line success immune Second, phase both trials of cabozantinib the combinations, late-stage across inhibitor start-up we based

Third, collaborations both help from assets compounds. discovery business and in internal we and milestones sign discovery downstream efforts with external our a and new with XXXX manner discharging externally to developments complement focused two modest scientific and aggressively preclinical additional and to small activities biotech internal We us advancing upfronts financial beyond look allowing development are to early-stage assets of low-risk in success-based risk. cabozantinib clinical gaining tractions advance and additional

performance in momentum the of all strong business. first continued Our of across reflects half XXXX our components the

early well royalties Since product in managing allows reinvest from business. fashion expenses and our we in our efforts a to well U.S. partners. to is on per cash sales, collaboration billion $X.X royalty its Our us generate billion and milestone have approximately $X to cabozantinib as from payments related rigorous sustainably becoming brand. in to Globally on revenues XXXX, way cabozantinib as generated cash upfront, grow milestones our product free sales year from

highlighted company recognizes have was by which most that MidCap including currently which the passed many profitable strategy growth recent having biotech's in companies that Exelixis index are the potential. one the requires our still is financial the recent consecutive four robust of challenges of Our Exelixis two stage XXX have Index quarter. the in inclusion only quarters of S&P early

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

Christopher Senner

a over comparable of for net of revenues XXXX Total $X.XX On revenues the basis, per revenues compared approximately period period last $XX net product our of year. increase net a of a $XX.X inventory revenues growth the the same RCC. period and weeks decrease were demand June which in million include total of revenues the sequential share decrease $X.XX with Thanks by result quarter last increase by by in diluted same an trade product share of XXXX product offset for in or diluted for to million million, reflects $X the continued million the income X% quarter-over-quarter trade in treatment XX% GAAP hand. XXXX Mike. this million Total earnings approximately The $XX year. was increase for CABOMETYX of a inventory in advanced per XX% ended $XXX.X XX, million million increased of of on for is the and $XX primarily $XXX.X $XX.X driven million revenues earnings compared of net income second the net quarter GAAP CABOMETYX approximately to patient

net revenues sales of doughnut Medicare primarily the million Our revenues in quarter quarter XXXX the that deduction second from include of in first enter of the decreased patients cumulatively XX.X% the milestone as hole $XX.X XX, XXXX $XXX period a quarter. primarily the upon gross XXXX four for collaboration slightly the million increase million to lower The cured the sales Ipsen commercial recording June earned $XX quarter collaboration of to XXXX in compared comparable result to XXXX. quarter million consecutive the over to when ended in we for in Total also due from $XX reaching revenues compared quarters. was Ipsen's of second claims

$XXX period tiers. Additionally, cabozantinib and of now second Ipsen XX% quarter net will between cumulative during tiered the XX% the annual be million and royalties initial surpassed in earnings based royalty net sales certain sales during on

the the with COTELLIC quarters, to we recorded revenue impact prior COTELLIC related of of in business Roche. share Genentech collaboration During $X.X million we SG&A. recorded In profit our the U.S. quarter, approximately

and a revised for revenues. a second now During received profit project that collaboration quarter, XXXX forecast we we amounts record therefore the as these

XX, million quarter long-term and total marketing for and with Cash our and non-cash investments XX, personnel, guidance and be its in And and will XXXX the guidance and short long-term expense. cash as were to operating call and the to and that million. first total million in costs compensation This $XXX is and $XX XXXX. costs for full and $XXX expectations. approximately $XX.X increases were and maintaining now the compared and total primarily related compared consulting This $XXX.X stock-based cash second company quarter of increase to and restricted expenses totaled million million equivalents result I’ll the includes payments to expenses primarily $XXX.X costs million over is to of Invenra expenses of in at expenses Our at investments between June line short December expenses P.J. the in turn million finally, XXXX year XXXX. $XXX.X cost

Patrick Haley

Thank you, Chris.

strong growth end to the by with performance CABOMETYX of highlighted the demand quarter pleased XX% QX. relative second are sequentially customer of We in

totality the a superiority in on CABOMETYX to long-time of first-line of a which Sutent trials last motivated to Based Afinitor standard and due and demonstrated CABOMETYX As indicated the TKI as category. broad kidney risk received foundation the RCC advanced an provides This patients all make, indication for year the data and the CABOSUN or regardless strong to strong U.S. RCC. clinical clinical METEOR the a in from CABOMETYX respectively CABOMETYX expanded of therapy care of prescribers late feedback, customer of in are use label cancer. line of choice to

clinical disease. terms TKI As pool approval of to growth towards more first-line continue first-line treat categories. by with a academic of is of both by Consistent significant becoming base in across XX% community of the and cabo us the QX. QX growth of The continue eligible increasing of cancer. community relative this highlighted we demand Despite see our as we FDA thinking, and patients option patient of therapy grew increasing launch progress CABOMETYX RCC, driven new market XX% by the adoption the in the in made RCC the to the enables in the in kidney combination previously choice growth we very prescriber have our increasing treatment oncologists lines stated CABOMETYX and goal risk continued broad was with approval prescriber competitive and utilization to both by April. ipilimumab/nivolumab physicians

upon who options. in sequencing by first we of by progress. RCC the market upfront that continue opportunity the line which market year, out the have that of of cabo at indicate course utilization treatment receive many therapeutic followed patients the of of they quarter. the conducted see The importantly be CABOMETYX enter by And will receive the in dynamic feedback data the setting. play research second as research will from patients combo large majority largely KOL to cabo will the chosen of to driven I/O We this second Over an or followed end indicates I/O cabo will extensive half therapy the patients these this market of and to I/O progression, sequence. The began majority have

Sutent, CABOMETYX, share TRx the three increased Looking of Votrient IMS going in XX% and XX%. basket QX. market And for volume at to relative points to grew CABOMETYX data, from by QX, INLYTA. XX% CABOMETYX the

we're are with progress, QX moving satisfied continuing in market to RCC grow forward. position we the While remain with pleased it and our not on our focused

Hepatocellular the the look cabozantinib the expansion is label potential for tumor on is opportunity medical are annual cancer a A nearly over in In In liver since of HCC, there liver the diagnosed attributed deaths we U.S., year. unmet in growth forward addition the would is to primary recent the expanded through patients basis. HCC third need, franchise. XXX,XXX approximately to CABOMETYX through deaths a and accounting RCC number to which most article U.S. in XX,XXX form the XX,XXX growth common continued and of cancer, represent cancer each globally the to significant carcinoma This Liver has therapies the for health And fourth one indication, of an type cabo are York a drive the XXXX. indication introduced. single-agent with market in and was under double in deaths cancer New differentiated both play This until therapy. the on mortality role from addition a as there as these as to and cabo have only options in of cabozantinib's new key served to the as in have Exelixis activity been this market with approaches. thyroid worse. RCC HCC been histologies. the advancement the as approved other is year, The years, patients to U.S. I/O increase are getting and coming for will problem systemic last grow data Times, highlighted significantly HCC, in well combination potentially intends HCC in recently decade, potential over therapeutic long presented

for and view them Gisela, forefront clinical excited tumors our thyroid potential where regulatory and cancer, future combinations development from potential We're plans, satisfied. long-term and offer are franchise. opportunities commercial HCC, are other about indications potential markets and requirements like these opportunities of the heard cabo assuming growth, future for as RCC, you we near-term with the would at new differentiated As inhibitors the checkpoint of

million. robust action. the leading its net to States, based the in of QX clinical with and continues of $XXX.X XXXX, be cabozantinib well United data antiangiogenic differentiated franchise Finally, is TKI unique revenue It mechanism on

CABOMETYX. RCC benefit We from results that are of but could pleased with QX, believe many the more patients

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

Gisela Schwab

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

XXXX, III poor Also the the on the XXth Phase May, the cabozantinib were recently The outcome July previously risk filing labeled late and HCC RCC, the the These and commission treated in in of HCC results EMA mid-March, sNDA supplemental patients. granting NDA patients expanding Xth, filing of intermediate or filings March, we our XXXX. U.S. untreated placebo versus the in Medicine. applications in Ipsen's CELESTIAL, accepted the FDA Ipsen the filed First, indication. of previously treatment approved published previously labeled in review, treated filed E.U. for of validated European with in XXXX on date our our trial PDUFA patients. for England based January EU the treatment and New Journal cabozantinib of for positive were of These a further

globally. in inhibitors these cabozantinib the progress and collaboration plan nivolumab are management focused our with HCC or completed checkpoint Roche. CheckMate fully with of evaluating the XER both and lifecycle ipilimumab nivolumab combination With broader earlier and and The ipilimumab. X, cabozantinib the preliminary to very the of we're safety cabozantinib trial, nivolumab for combinations HCC We're with with cabozantinib. naive BMS Phase patients, this development achieved, pleased combining study And with important BMS, Including Genentech our advance alone, on and clinical X year. enrollment activity and collaboration nivolumab cabozantinib treatment and Phase Ipsen It the cabozantinib nivolumab and Xb a milestones immune evaluating assisting with collaborated The the evaluated established combination ourselves together This patients is Phase triplet malignancies. making a III this sunitinib, versus BMS ongoing has recommended separate safety in for the and trial cofounded dose is and making is in combination the ipilimumab, and Takeda, who development RCC trial, patients And triplet with be is and continues preliminary of genitourinary to protocol of investigating Phase enrolling with study. tolerability combination progress. nivolumab by in trial progress, the our and ipilimumab, advanced for combination. conducting and first-line versus the in nivolumab

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

will identified an the our cell types, dose Further bladder stage Based this and We now including initially cancer the the we gastrointestinal programs for cancer, HCC, Ipsen trials cell first-line studies are and in tumor and various dose and planned late indications with ongoing and cohorts, malignancies, to are in in second respective in agreement. RCC, cancer patients. expansion the are the inhibitor quarter, that have adding tolerability various partners, cancer, we important cohorts, investigating non-small lung trial. settings the enrolling terms on and histologies actively additional the in to including under future each non-small combination these of cabozantinib a GYN malignancies, XX And checkpoint in combination good participate and including collaboration part have active discussion, their accordance variety opportunity Takeda, bladder the of combination trial, expansion of with an of with ranging atezolizumab, a combination announced

time. on at look designs the in on and trials for trials pivotal to planning specific tumor in sharing are to for start and time. our types such We XXXX appropriate study advancing details at forward and next with work the other XXXX, studies are this We in cabozantinib

and are preparation internal our several breast Such our to cabozantinib addition in of cooperative checkpoint moving which a endometrial cancer, studies triple-negative trials cancer, for was encouraging with and group, II of shown the landscape plans. arm. agent cancer that cell abstracts lung types, differentiated with into and recent study partner in inhibitors. year, activity of concepts PNET the control by cabozantinib advancing cell or revised patients. The cabozantinib Phase modify cancer. non-small carcinoid now nivolumab it's being III and accepted In ipilimumab, tumors, open takes at program in are through now earlier publication account inhibitor Phase first-line also and the your Phase are checkpoint nivolumab and in both investigators and ESMO treatment trials X NCI-CTEP by of opened randomized including study cabozantinib quick has I'll multiple various forward cancer Phase therapy This single and alone to and integrated close, for PNET upcoming combining with preview being clinical in To lung is non-small efforts, investigator-sponsored therapy. immune And provide and by tumor The presentation. indications, there in standard trial second-line changes our initiated carcinoid, conference the variety indications modification recruit trial, including ourselves. Munich, thyroid review the lastly, by combining is has At actively being alliance a the endocrine the this care X been to October various

dose of see trial will presentation mature. is follow and up COSMIC-XXX sufficient the when and of be data Expansion data presented study a will We available escalation cohort the data atezolizumab from combination first the experience. cabozantinib this

studies forward Other results will in inhibitor this of These intervention. immune cabozantinib-related cabozantinib include presentations checkpoint presentation October. study disease following interest We real-world on at frontier based from at levels number look to future analysis protein analysis of our HCC presented. from local various and include investigator-initiated and from studies activities a by treatment. burden analysis of by Phase Additionally observational the group be X ESMO sub and baseline prior results advance

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

Michael Morrissey

All right, continue half year. in that forward thanks Gisela. XXXX the the to into business progress of close in aspects solid see saying as the across I’ll by all our first move of significant performance of we the and made organization half second we

provides new a success R&D pipeline indications cabozantinib to Our and QX our important to augment opportunities notable commercial explore to future for internal and financial strong platform trials and new in efforts. and external

had XXXX, of entire the The And energy first even work call we for the granted While for fulfill longer. look cancer. and a enthusiasm urgency where strive progress. thrilled interest making across half solid remain on in you to and focus our is extremely questions. are to as our continued new strong vigilant happy deliver success patients with updating your and and as completed we team day every to move now our and the we we're don’t Thank the organization to We Exelixis. Alameda to in level mission to campus therapies support help we this with open for pervasive growth with recover live you more forward patients to to cancer, have count take new in Exelixis

Operator

Instructions] comes line with our Andy [Operator the William first Blair. And of from question Hsieh

line open. is now Your

Andy Hsieh

congratulations the you Alameda in question guys I another hope strong my and settling quarter. new Thanks taking for on campus.

a is inventory million mentioned So increase in heard million there QX about it QX I correctly and $X.X drawdown. believe Chris call $X if a the I on

going think inventory about do how So level you forward? the

Christopher Senner

thanks Chris for question. Andy the this is

market in million with as So inventory associated our demand. generally a in did which we the have increase $X was said you increase end trade

about inventory. was weeks weeks So said Therefore our line three around with demand. as of back it grew and and I was In just on on QX in our QX. it in hand hand then

units in trade of was here, the in about and by in we Now QX that $X down inventory number a million went did see actually $X million. of reduction around

working they as speculation they Our level, weeks fallen destocked the quarter price. to quarter wholesalers the capital approach on manage of historically they do as internal take their have sometimes end has low generally metrics, as on and ability the and hand end of during the to year they many the and end the don’t

we in hand Now think do weeks is forward, looking on best time that three inventory or - suited amount. our

of And so way we it the forward. that's kind about think going

Andy Hsieh

launch you're an front-line PDL-X see additional RCC color. as the the frontline of prescribers. following seeing what the P.J. of you RCC And ipi/nivo am I the Do looking curious for frequency approval? we’re Thanks the at so uptick in about terms among testing

Patrick Haley

the PDL-X. third patients I approval. it’s to in what dynamic change Thanks after said for broadly of is see that question a testing see early tested That for Andy, we the being the do think about the

the that the second of or So cabo what's poor. to whether lines certainly totality something of was with broad line and label therapy intermediate data we’re monitoring utilization kind first-line, nice I seeing kind think the across we’re groups in favorable, of the regards and risk it's of across

some the where of bit seeing are end therapy. a of coming we patients the sort Importantly, of getting combo at of nivo/ipi quarter a off trend

that's think cancer. reinforce the we going opportunity potential to choice of kidney I as position So in forward our look TKI as a

Andy Hsieh

you negative Do being the used meaning ipi/nivo select positive for patients to cabo? ipi/nivo that is testing PDL-X for think

Patrick Haley

point combination. indicates bit certainly it’s to that difficult they're say this data at significantly negative the receive I’d early a if Yes, to limited I’d less say say likely PDL-X their

Andy Hsieh

the question last think disclosure ongoing expect of COSMIC-XXX conference? me cohorts from results ESMO the for it’s we and for so how obviously data the about XX we timing do expansion should Gisela, And for How the trial.

Gisela Schwab

the study I will the be becomes and on abstract I data publish dose and earlier, very as cohorts ASCO mentioned cohort on been presented. think has for as the in accepted little and matures of data a we to that that escalation present And presentation. we the bit abstract part regarding pleased focuses available are ESMO

subject and presentation. evaluation is that So future to further

Operator

Markets. question RBC comes next our And with the line Capital from MacKay of Kennen

now is open. line Your

Kennen MacKay

one taking you the Thank for P.J. again maybe for Quick question.

beginning to the help come at come this patients if could and wondering, on who or is I cabo. if whether of if there events sort you mentioned the of are anecdotal they also you've from end had on to off us then the some wondering were of feedback are from review they sort to evidence from cabo this on progressed just was force this biomarker is where sales adverse more understand not that quarter comes ipi/nivo As were chart type ipi/nivo or these patients these ipi/nivo? who because due positive data. were had the field quantifiable And patients perhaps coming is because

Michael Morrissey

specifically patients, to the know those coming that would out can't that trends that to this be I sort With line. well in line first quarters. in we’re nature TKI from paradigm. Thanks we’re for the are question small is regards data some Kennen. from carefully. And I’ll et start I of of the maybe at continue with That point of dynamics the market we the second things have cabo the sets actually said, this answer I to go quantitative to think well on data you patients in couple and - that cetera. off research year, And of extensively certainly that all talk hypothesis of KOLs believe we the a of and this large as confirmatory had in prepared remarks mentioned market we've that research is this of think well I/O proportion done of comes on which cabo coming what likely think the second positioned in that we sequencing the choice the certainly that sorry comment I as combo as kind watching to play

Kennen MacKay

these us coming on as bit to where we I and very to stay And maybe a drug a from I/O to then much. the incident checkpoint of we is think any want Thank still combo? I understand how you then, versus before, choice VEGF? go that, guess cabo back data the to the there commercially more non-biomarker that's in again, wanted give XXX, sort could internally front-line patients, to is just of And of little from can about Ipi/Nivo newly sense you as to then sort there patients out long in positive expect patients Ipi/Nivo

Michael Morrissey

regards I for set, Couple of going address. to data of I'll those of spectrum things there it's PD XXX I best In data. XX% point I in to it's the progression, would mean, obviously that patients. a with was response be the trial think the out that the

as see a first-line, as what certainly data, KOLs to well as cabo a of could patients, - could see patients research, or the bone in we're we research With in cabo You'll who spectrum bony there. is attributes disease, as the here a be really really cabo patients to regards who in is that well market are be disease choice appropriate our talking the driver recent rapidly really maybe for from of and with really disease progressing quarter. tick-up those in seeing mets symptomatic seeing perceptions kind the of the

in we're as those second the into patients to line. So, therapy patients it I going think believe we there's well as capture certainly progress on mentioned sequence, then I I/O the a place for in first-line and therapy positioned

Kennen MacKay

final And pipeline. more then perhaps just question, on one

internal out. the timing estimates very Potentially Just with for be there? expectations your for wondering we could and changes could expecting that if you you front-line read potential much. us Thank to help CaboNivo any when

Gisela Schwab

XER globally versus patients at first-line, the the is point. of this CaboNivo executing regarding data. study, study [indiscernible] studies For the actively topline expectations completion we this this enrolling BMS spoken study or haven't to study really are of and

study the matures as progresses. come to something and that's So,

Kennen MacKay

perhaps that late the to I've just And be was if wondering I that a one something maybe combo going at ESMO the for quick a been looking seen was haven't follow title breaker? data. was and up.

Gisela Schwab

combo I'm Are data about? are sorry. study? talking you What you talking about COSMIC-XXX the

Kennen MacKay

Yes.

Gisela Schwab

you provide published, we so that. list That is can

Susan Hubbard

the you we I the all grade list it. will send titles have

Operator

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

Your line is now open.

Peter Lawson

the do of how pricing, year? about you the thinking think rest pricing for Just about

Michael Morrissey

going at question. go may may did evaluate of what pricing we take. to guidance around not we're and price Peter give we we Thanks or end to to increase to mean the continue for any the as We specific continue I price. actions to not but take the evaluate X% June forward going

Peter Lawson

you - mentioned experience maybe kind a And increase so on cabo it it the is driving of particular question about then increasing, set that that's is or more of perception for just the data perception? P.J.

Patrick Haley

Yes, the Peter. thanks question for

we're certainly I is, indication is - think what the to sunitinib. part really With data superiority though that being experience and seeing CABOSUN regards of expanded the a demonstrated over it. driven I by think

that thinking survival. to overall with across what the when survival terms TKI, as data when particularly settings physicians they efficacy think really mid-year in really speak with and progression sort about is free and trifecta benefits to coupled strong we is go of rate So, I of data response

So it's the of it's promoting there that great in and a marketplace. team - fact working out job of think is doing that and totality the data really really I the our

to that's continue see think driving share strong across I voice the those increased execution really perceptions. We boards, and

Peter Lawson

And migrate on versus patient of seeing groups how then use kind that PD-X, more cabo kind could first-line marketplace be that particular of or that Is you or think you're potentially just to practices kind finally move? of there cabo? likely

Michael Morrissey

dynamic lines. so, it's Yes, think I market across - very

which for they rapidly - immuno said preferential that speak in who therapy. may disease, be might to to, time. sequencing or be bone with to could symptomatic think disease progressive want play mention is the bulky example, metastasis disease, from first-line regards those response so really patients. patient preferential for wait, no on We disease, and a I efficacy cabo of I think, type over we out do with see as I is we're going those to kind

going landscape importantly to from in have opportunity these patient sequence majority is therapies just both the perspective so. get really the to continue the think I the are patients of which beginning to evolve, as though,

that coming forward dynamic out to providing the look certainly So, plays in as color quarters. more

Operator

Stifel. Stephen question next with our of Willey from line comes the And

Your now is line open.

Stephen Willey

there just just question are in the going to think maybe there treating therapy. to also the number of I/O notion the of eventually you with progressing rates second guess impact that Do who any eligible this think then about we line of CRA asked to I/O? XXX, respect and with guess there to patients I out saw progression be some specifically that we I as I is higher front-line on physicians be And kind treatment patients? the

Patrick Haley

the first-line, in rates largely think the I But will marketplace. treatment relatively dynamic again, - remain think stable. I

coming The of retrospectively I whether go and typically therapies, we chart markets market potentially over with the therapy second tend more do over last very But or and this increase more more a reviews. but something see really new see up certainly time. generally, you decade benefit somewhat, of treatment over it's market to rates through line, and they time obviously of not it's certainly decrease data patients think and lines other lot to to treatment could sort then

hepatocellular patients type more the carcinoma, that into what thing space, we're of of we of at therapy. lines looking of treatment is treatment believe think the particular see dynamic in we'll more in coming kind options I getting subsequent

that as So, look well. forward to opportunity

Stephen Willey

question a for And Gisela. maybe just

opinion the CHNPs And seem as they isn't emphasizing to benefit be really of regarding some rule of wondering I Xb trials, of agent pre-confirmatory kind trial option think how regulators contribution to ongoing really RCC. nivo that provide of in EMA reading TKI guess the XER benefit. you opinion that single combination also of looking both benefit and Just front-line of just or for? and maybe a in the respect attribution arm if front-line attribution that other to with I/O competitive a there where context about

Gisela Schwab

I you of potential combination - therapy of single outcome application in the overall CHNP combination by of by of the as highlighted compare it's think, to a as the treatment. for really toxicity to partners the agent issue nivo the contribution view question added say, components

regulatory to not unique it’s So and as such question not surprising agency. a any

single I agent and the a contribution by not line trial much comparisons. activity to is And the this agent cabozantinib and or first as also and the I supported either agents. contribution single demonstrated you consideration. future think this as about in it and we trials of with for program, trials So combination component trial so designs we for as so the question other very question new setting are is as thinking and we the setting activity that the ongoing be such as trials, evaluating together And comparisons these very of real obviously designing the within part is a and has broadly of think cross cabozantinib know in When cabozantinib XER put you approved in study. are of

Stephen Willey

revenue be Thanks. flat speak in be guess And this just bit sequential quarter. last fairly you sales? be question the and Roche can collaborate I what context one to a just then may Chris, this may look for COTELLIC last little of higher to the year-over-year

Christopher Senner

we a and Yes, so there in revenues it flat, from expense related versus was time And were a that's year. we’re ex-U.S. the U.S. the which quarter brings second for and profit on where was the perspective million our it from a now the reduction profit U.S. situation relatively related during perspective royalty was - year. in the to a last a loss recording share been year this those profit we’re and was $X.X profit now and around but business collaboration the into forecasted that to U.S. to $X.X revenues has million some

sales necessarily not but of expense. the to the linear it’s So reduction U.S. completely because

Operator

with of next Our Instructions] Cowen. line from [Operator question Boris comes Peaker the

is line Your now open.

Boris Peaker

on - on So compare for second can comment patients can revenue patient, cabo? my on per you and first how line RCC revenue question is third just first-line you compares

Patrick Haley

is Boris I'll take this P.J. that. Sure,

I line and what to but about the how patients tend second think as new see and Typically treatment. healthier of we opposed various kind line. line therapy dynamic changing the dynamic options therapy time the of of on therapy that from earlier we you overall the mentioned being in marketplace third the line forward so tend patients in over sequencing the duration as with do patients to that's it. move the go to longer typically certainly you more first-line of I first-line slightly as the the then said, a with change data be could be That trials think is all somewhat demonstrate in

Boris Peaker

just you comment of like of duration maybe But has on is the treatment or can line basis relative a XX% figures? of first-line for let’s if kind second average it in patient a ballpark XX% say

Michael Morrissey

comes what is to what on similar but see want trials, duration to comment we we about sort talked that. to of or speculate When Yes. wouldn't it clinical we've seen beyond the in

Boris Peaker

opportunity question in and any strong promotional curious is I’m And my RCC way, driving certainly in really in met saw part an differentiate? studies. signal you your effect of to very just sales your it seeing are you clinical a in last this effort bone is

Michael Morrissey

that think more kind something very data, as there think in if types I that it's out you subgroup can mentioned and our clinical to be these of is particularly solid likely - much KOLs patients mindset feature there the see I CABOMETYX the of Well, certain you look make in - first-line setting that at a that and benefit of I the that kind trial. where

differentiator think is So, there that's of something and bit that certainly a RCC. for I is CABOMETYX out that

Boris Peaker

And actually question. one more

I'm on Just I up? just what patients CheckMate follow on XER arm, they follow curious, Sutent therapy their mean, up study. the on the the options. get can are for I/O

Gisela Schwab

the cannot Sure, But subsequent study, and on whoever any specified not when study, therapy can care. enrolled subsequent additional this anticancer are are they agents. receive in patients discontinue have they available

Boris Peaker

of follow-up? do have patients of kind fraction may some what therapy sense of on any getting I/O you And be

Gisela Schwab

trial. that. into At don't an view We this any it's have point ongoing

Susan Hubbard

still enrolling. and Yes,

Operator

Umer next the our Evercore. And comes question line Raffat with of from

Your is open. now line

Umer Raffat

looking in end, the And I ipi/nivo high hoping is as remove survival up. offering XXX, you risk And cabo that setting My try question informed as cabo a that you and the patient benefit to compete to had in the have a it market are or is, low-risk follow better to saw position a arm. the you with what nivo to CheckMate are well? opinion specifically so nivo

Gisela Schwab

Sure, questions - XER what your amendment study, motivated of and the here the to just study.

the to it the and wanted outcome is sunitinib, the and ourselves to for positive that nivo/ipi. really third about focus study jointly the of to [PNET] When comparative question survival true you decided CaboNivo it versus felt combination Ipi XER remove of that XXX arm CaboNivo of prudent address and the was benefit, the was because really were the With executing we CaboNivo by that think and study. we Ipi

Umer Raffat

high-risk positioning risk patients? perspective, it this it where meant And do from what's compete like, patients ipi/nivo you head-to-head intend a for really for to versus really regimen, ultimate will is position or to in the is the - low intermediate market a

Gisela Schwab

risk categories. all study includes XER The

and study included So, XXX addressed population the stable favorable a that with subgroup. XXX the outcome, risk but or not was broader you outcome said. study well in The as as

the similarly who of and safety make eligibility I think so, treatment addressing available the patients review study their it's certainly if other patients and therapy, determination. I - combinations, to an and the TKI And and have succeeds physicians and options think certainly I/O will the various profile

Umer Raffat

in European And then - to Bristol recent was, and of back one And that couldn't my CHMP ipi/nivo that speaks I feedback trial got was what was. design. perhaps final think contribution from on understand the that side, the RCC euro they incremental the

would - road that I nivo you how So you design question down guess my that view CHMP XER? the review inform how the that inform do given is, potential lack how trial regulatory - and would think decision how how do and the

Gisela Schwab

a negative outcome. the CHMP to you [indiscernible] outcome, as opinion by information to so about in of contribution concern absence overall ipilimumab And the their remarked they the Yes, partner. that the that being to in the had And unable determine comments. was potential opinion combination their the that the add - available, then said, they to were of

is currently XXth So, think as July. I of of that the the status

of the said terms combination, the on In I as CaboNivo call. earlier

I situation quite that can safety RCC. the product [indiscernible] first-line back think from which single-agent on we or is in in have is fall data supported is older differently and nivolumab, a activity study we - that cabozantinib approval obviously the cabozantinib the first-line established has very ipilimumab of where different

Operator

are questions. And this no there you. time, at further Thank

Hubbard. I'll that, turn over today's with Susan Hubbard? to the So Ms. host, call

Susan Hubbard

We and great all rest a you certainly any additional you you, have welcome day. a for Andrew, we address today. calls Thanks joining have may with thank lot that your today. follow-up your and Thank us of didn't questions

Operator

today's conclude in participating conference. and wonderful a Everyone for all the you thank does have disconnect. program, gentlemen, and This may day. Ladies you

Exelixis (EXEL) 1 Aug 182018 Q2 Earnings call transcript