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Bristol-Myers Squibb (BMY)

Participants
John E. Elicker Bristol-Myers Squibb Co.
Giovanni Caforio Bristol-Myers Squibb Co.
Charles A. Bancroft Bristol-Myers Squibb Co.
Christopher S. Boerner Bristol-Myers Squibb Co.
Thomas James Lynch Bristol-Myers Squibb Co.
Alex Arfaei BMO Capital Markets (United States)
Jami Rubin Goldman Sachs & Co. LLC
Jason M. Gerberry Bank of America Merrill Lynch
Timothy Minton Anderson Wolfe Research, LLC
Chris Schott JPMorgan Securities LLC
Umer Raffat Evercore Group LLC
Matthew Phipps William Blair & Co. LLC
Seamus Fernandez Guggenheim Securities LLC
Andrew S. Baum Citigroup Global Markets Ltd.
Steve Scala Cowen & Co. LLC
John T. Boris SunTrust Robinson Humphrey, Inc.
Vamil K. Divan Credit Suisse Securities (NYSE:USA) LLC
Geoff Meacham Barclays Capital, Inc.
Call transcript
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Unknown Speaker

Good day and welcome to the Bristol-Myers Squibb 2018 third quarter results conference call. Today's call is being recorded. At this time I would like to turn the conference over to Mr. John Elicker, Senior Vice President, Public Affairs and Investor Relations. Please go ahead, sir.

John E. Elicker

morning, good and Vickie, everybody. Thanks, us Thanks QX the for joining call. for Officer remarks Charlie Tom and Scientific our will and as Commercial Lynch Christopher Officer. Chief have Chief are Giovanni Q&A prepared usual Boerner, for joining our and us

take get Safe Harbor of we Before care the I'll started language.

important update going plans certain forward-looking at these result results During as materially We're reconciliations financial may even of estimates representing Giovanni? measures we'll as future from about change. focus our call including be forward-looking not constitute adjusted our a that available factors those to to the statements statements call relied estimates exclude website. prospects in specified and various today measures GAAP statements any forward-looking SEC by we statements, of specifically to our discussed if also differ comments of date which as These are are our the non-GAAP filings. on upon should to comparable items, future company's during our as measures the the represent indicated the make most and those statements, these actual disclaim estimates our obligation of company's forward-looking any

Giovanni Caforio

I'm we know you I've going that things on of you, non-GAAP growth I said, frustration strong you. of to perspective of XX%. have. my to your from that you some some Thank earnings concerns of announced X% heard of per everyone. you good wanted I today, give many acknowledge aware John, and quarter morning I'm that Today With of the and very the another with sales share growth

your and my the for into color XXXX Chris on how financials the filing on some our with here thinking Tom then the and about quarter I'll start going perspective provide I'll TMB Charlie questions. are beyond. provide company am I me will and discuss the news on finally and Let

first discuss TMB. step where we are back So and let me with

the to of following believed TMB options that. an best is unmet have always to need areas of in and pursuing patients. We example high bring the science important

based As study we We statistical for XXX improvement had in the patients in to X. a this TMB and With emerging regulatory in part described and recognize in and data filing OS a always to earlier demonstrated authorities TMB no have we review, that on way complexity. complex OS did Xa application. impact PFS we PFS. current the to year, remain increases the significant working plan we high evaluate that it part amended for committed that going to the with for data the be regard said We this health TMB, a was additional on on

TMB's important to institutions as We in Based the of and our working continue advancing look TMB. the as TMB play to to understanding scientifically believe are know, as a will companies seen, academic this well role cancer we research other and forward everything on treatment area. of we've several that believe you in advance we

our We trends well. saw Opdivo quarter results. demand and another continuing across company. share strong market outstanding to We our now positioned great be execution portfolio Turning Eliquis growth the to in delivered meaningful and with with

a well I-O in performed highly our market. Specifically, competitive franchise

we maintain Our share. strong lung results, existing including indications second-line contributed where a leading

well. Our new performed indications also

begun melanoma markets We as Germany. for in U.S. to reimbursement indication in such in the adjuvant Europe continue to early strong see have the the launch uptake and

about in how established feel and and I-O the debate Opdivo approved very first-line Let lot about second-line three treat of other me this who indication, been so renal turn leading know going in perspective. newly-launched physicians to I to almost We has the evolve, we've my our is were been market give We've I news there cancer good you let very agent the competitive a me for renal. on market. first market setting in years. position. renal as a calling the

risk. which includes in well with tolerability. for the to commercial successful operate markets a strong confidence Yervoy this approval poor patients the by combination rates, We I the in achieved compelling first-line, in the overall With to survival, response Opdivo plus competitive leveraging in and complete be We've the in leading around treatment full market is and the and executing RCC. competitive world and intermediate organization already profile for good have continue

Opdivo, believe on indications forward based the continue of the quarters, to on today. strong we for set trends through current grow Opdivo based XXXX Looking that in three will

Eliquis, Let turn franchise key in growth other the to now me our business.

strong and opportunity the that continues incredible prevention atrial has value become an seeing U.S. clinical milestone, I'm This are oral Eliquis trends the in important for confident is stroke the in in Eliquis reinforcing offers an to #X now going fibrillation. Eliquis that forward. have We anticoagulant growth

solid a Now, growth. into business our The in foundation looking ahead XXXX. gives for us momentum

growth see and in from potential a for of drivers coming beyond, further future, XXXX Additionally, number I sources. the

in oncology. First,

We trials have tumor in XX than registrational over XX more out XXXX between and now types. reading

six across This to progress with early area respect in readouts this With great trials indications an ongoing with the multiple includes in now beginning is Importantly, setting. pipeline. the XXXX. adjuvant

for this see we've that One to X registrational programs to applied to of where X decisions enable expect we've where data to the I-O things moving XXXX. helpful, randomized learned in we data go/no-go assets earlier possible, is before to and studies is it

my made our of we've one portfolio key to I XXXX. is to and priorities know, I further think key some progress diversify in want highlight good you As areas.

the in Crohn's, and very look to broaden September the to on opportunity III Phase in in forward moved I as based the based and TYKX program Phase other X psoriasis readouts we've the First, TYKX data Lupus. on indications, such promising saw you potential into UC,

enable finally nitroxyl we into beginning data that to phase to FGFXX XIa, externally, registrational potential In to long-term Factor will a am year Business respect agent diversify of now and X. a needed This as been that from the the addition, earlier always program. priority. is start. year, started portfolio, our a Phase X a And partnership program, With Janssen innovation to support entered expect with we which this inform Phase X part for the we've has core I focused source very growth. Development a then we company on. remains further our strategy donor One look next

quarter, sheet to for specifics about balance longer-term it that, for this Charlie strong next regard. good I head gives flexibility performance intensively closing, in growth. the we the operate, year, the more of in quarter. With in on acknowledging the into momentum Our us competitive breadth where and our feel while over business opportunities we markets hand as our the I'll In

Charles A. Bancroft

and Thanks, morning, another highlighted growth Eliquis. strong This company Giovanni. brands everyone. by continued key Good was the quarter our including across Opdivo for

mentioned, U.S. cell trends first-line and Opdivo As with in we remain executing in a are high-level renal at our new the Giovanni strong melanoma and adjuvant launches

see in strength our continue of of by adjuvant to metastatic the across and are renal at in Yervoy of we U.S. international indications business, continued cell securing Looking we reimbursement regimen continues early melanoma. launching melanoma. the for growth leadership the uptake regimen the and in to core driven the in Opdivo-Yervoy The of and days be

will growth in during the the really Eliquis #X prescriptions. good With Opdivo to mind, about strong became in OAC Also contributing that commercial execution XXXX. our quarter the and in which we U.S. in feel the these deliver competitive total expect position trends was

headroom by of up profile reduced ACC market in earlier warfarin volume net TRx impact (XX:XX) Ester XX% real-world quarter, compelling TRx Eliquis gap the this strengthened leading the is when important agent shared at XX% roughly second most for million. further as in impacting believe prior-year, has We was remember growth at of While approximately inventory Eliquis our the position pronounced such third reduction and were quarter, sales will as versus U.S. Eliquis' Also believe that year; it's by sales million. and NOAC leading to and the study was the share roughly an coverage further that to be we the class. in Foney $XX expanding compared data with significant $XXX

items our of P&L. like Now a non-GAAP I'd from highlight to number

mentioned we to the a As product of our mix are on see back in impact of gross I July, beginning moderating margin.

differential R&D. order remain facilitate Regarding behind to OpEx, disciplined we in investment

tend we the year. towards final of investment phasing of quarter a know, the see you As natural to

of allocation, increased finally, due with the to And previously and I respect and to due favorability priority. other of a of tax mentioned, We prior was we Giovanni the regard basis BD alliance periods products. mentioned, as in revenue income has I'll royalties largely our in U.S. on expense release tax flexibility and favorable Reform. mainly to rate, as quarter a and and revenue from impact Based continued As view now XX%. PD-X Tax product growth sales capital We rate our to our that and to provides top gross financial margin expect sheet the approximately diabetes of a on will maintain the reserve With on very from deliver and as us be a strong guidance. strategic, evaluate and we to of percentage XX%. now financial effective high-single-digit mix, the expect roughly opportunities to significant trends fit. scientific move to strong balance their range

by these revisions, current EPS With our our are $X.XX; guidance increasing as and guidance range rates. foreign we non-GAAP exchange always, assumes

back John it to to start Q&A. turn I'll the Now

John E. Elicker

to Thanks, think Giovanni, we're and ready thanks, Charlie. questions. Vickie, I go to

Operator

Markets. question first Please Alex Arfaei ahead. will we BMO And you. today go Thank with Capital our from take

Alex Arfaei

Thank very I all you the Great. much, appreciate color. and

What First about Tom, an It appreciate how better anti-CTLA-X I but at business first a just high-risk data then, view assume patients. your market? able on RCC, small the And going wondering as this data Thank I That's I is to being guess, survival Yervoy. question. is be get in to competitive appreciate tolerated. and risk I data? to data confidence is that ESMO. thoughts be early, increasingly I'm get your you. protect your wondering to from fair the your, that OS if Merck's could for fragmented looks is to active, given seems that that fully relatively the you it just

Giovanni Caforio

Tom. we'll start don't Why Alex. and move on RCC, Thanks, we with Chris then to

Christopher S. Boerner

question. for Yeah, thanks the Alex,

level-set I think back and really in opening comments. step the renal on dynamics beyond it's even Giovanni's to cell useful

physicians, business our is me standard-of-care let those, for in market get and here. so been of of number know north market sort we of years. these base share we're including book drugs, markets know major And have in of strong in by In know States, We us, little perspective the question they this bit our renal or of most United We've in cell. giving a of at at a of they many and second-line your XX%. a

So business. the that's second-line

both ESMO, share in may know, the and currently we the weeks you as to XX% be which, with at spoke was is should is U.S. look pointed out achieved plus first-line As at in post-approval, we we've range six with, Yervoy in customers the from standard-of-care setting, to the and XX% the roughly podium as low-dose continue Opdivo well as

and I ask of achieved of think if you success, why So things yourself, at have step that there play. think level back are couple a I we

profile plus we Opdivo good Yervoy. First, with a have very

demonstrated We durability We've is landmark just both well important really have I not as this tumors. and two-year responses deep talked durable as compelling compelling OS got but median other in previously, with think also data. in we and market, a as about

safety patient so and life well. quality We this has in Yervoy as profile, manageable an Opdivo setting, important in have a plus improvement demonstrated that's of

market, see you're a that will to are of respect long-term things true. a competitor much with but think the seen, we've I Now right, the fragmented you news more in couple

continue First, from and saw to at Merck, comparison data the seeing an we at conference. data that has life. very safety look overall forward that that believe need compelling the to quality Yervoy to competitive we complete to of with and we and response But on we coming ESMO, compelling we're see respect a with profile We're to plus survival, rates Opdivo compelling on we're profile. the upcoming

Yervoy competitive seen Now, what but cell. of how evolves, in we'll plus so good see about we on data competitive Opdivo based profile very the renal far, have the to we've feel

compete actually to feel setting. this standard-of-care. ran team's about about very that TKIs. in in in to second is not we the That the by this was our dominated it we We introduced we a the U.S. market when I The our launched thing space. compete setting has and same the played out market. of was very business ability feel team I only That in I-O, good dynamic continue ability good made to first-line but second-line

three promoting environment. are years. for is don't and net-net, in do So that we if things about space almost this I know we've the this been a yet very There know, step but things dynamic we think back

a will very profile, to are do and have they We I competitive every continue and exceptionally executing so. well, have teams the expectation

Thomas James Lynch

for you question, thank comment, Alex, on your CTLA-X.

not comment for do couple is directly say I things. just couple drug, I CTLA-X. on going I'm a me Merck's them tell better it's you of let things What to about So will probably a think to that.

CTLA-X is been Squibb of Bristol-Myers we've target. very that have been something of pursued think It's how I at a important extremely target. this we in proud terms

just CTLA-X. learned about Let's about we've think what

and but patients, big only if shown, and you areas look you have look we shown you all with you, we've of patients settings. and difference we're again, cancer, Opdivo can at if The just in if very and evidence bladder Opdivo cancer, cell response melanoma, shown at in lung in colon we look of in able lung We those see melanoma MSI improve renal a together a the that, you at made durability cancer, major are as we make plus that that something cancer, and proud non-small-cell we've think in where it's small-cell are made CTLA-X I is Chris dramatically if told those outcomes of outcome difference. improvements renal to not taking care of Yervoy and at look for that have

I all think keep important in mind. very those to are

combination is patient-reported treated I outcomes, Opdivo-Yervoy with non-small-cell be for that a is think and when to outcomes our a chemotherapy patients Chris I with treated at superior we that patient-reported in looked emphasize at can that you studies, to extremely of said for also we've backbone. think those the something find outcomes patients look patient-reported important

very that So a remains I CTLA-X think important target.

We think renal in very you it when the we're cell non-small-cell in it that also CTLA-X give doses is that and well-tolerated. giving

CTLA-X. In we're to addition, ways of continuing develop new targeting

This and into have For get the immune-related think will is CytomX. agent peripheral that example, a able tumors which developing Probody CTLA-X of some and to events. possibly will the anti-tumor events with be of we we an we're some preferentially modulate accentuate

I. a have drugs also these have Both readouts of We drugs (XX:XX) in of of Phase in XXXX. Both CTLA-X. formulation these expect to are some we

for one for very is additional So target CTLA-X Squibb Bristol-Myers to data in look presenting year. a next we forward important the and coming

John E. Elicker

question. the Vickie? go for we to please, Alex, next Thanks, Can the one

Operator

Yes, we'll with Jami Sachs. now Goldman to go Rubin

Jami Rubin

company a help it years company the they think were Thank opening that exactly the helpful, ago have was the made still materialized frontline after I you. failure feels exploring similar in while outcome Ipi-Nivo Giovanni, looking and very less lung bet the but -XXX role situation your market. frontline likely it's in was Bristol it and two of I the can't a Bristol-Meyers combo, much appreciate chemo way less comments, expected hasn't that like to and in is big will in of the we CheckMate in lung await clearly the meaningful

company initiatives that one did hear M&A something can an to not I'd likely low, you narrative, to to M&A program of announce Thanks. like the buyback even a relatively Merck fact we you though of clearly be growth urgency other the read your is strategic did, You the share change do options company? you're more what of the that. soon? are to against and supposed But stock into in at and a bets that was XX-week today that might important your there explore drivers or Is hedging like disagree, how most

Giovanni Caforio

Thank you, Jami.

questions. So let me answer your two

oncology First all our of on strategy.

as because strategy that been important very standards And, product If from in back, the and and to this would other some at replacing medicine when really focus new you into core of of when fair future, look Yervoy on where at look beginning, say the really for all first what say, has in I-O/I-O renal melanoma, cell the and an strategy successful, standard-of-care been believe areas, you of I has pillar patients established we've important appropriate. made way step of is is second, company. I potentially tumors you to a for care combinations we've a a it important our that

the matured, example, as chemotherapy has chemotherapy we strategies, some currently of tumors, ongoing across targeted with broadened like TKIs, which about of has I as to strategy and combining agents, a that important business Immuno-Oncology. With designed driver. types our specifically like with appropriate, the combination about work the my and broader broadened think Opdivo, existing allocation, shown case and the development are that respect data trials also agents have Immuno-Oncology capital approach clinical in standards-of-care so think and our question in renal for scope to including we that important continue recognize multiple it's cell, include really doing value reflected I is in is targeted where to prepared which remarks, years agents the over last to we've your to we has a few said has as

continue and it's also past, strategy said opportunistically. on allocation to development I balanced the times. year-over-year is increased capital the I'm I long do, we've we've and pillar our where repurchases was to multiple say, again As business. strategy. of felt for my have focused fairly right executed one to as business really committed We've to which linked really a of would time meaningful demonstrated said, it share that, a maybe the we've we've to it a In as I part personally, been diversify is more core And dividend programs priority the thing to

John E. Elicker

to Thanks, the question, Jami. we next go can please? Vickie,

Operator

Yes.

with Next Bank of is Gerberry Jason America.

Jason M. Gerberry

for Hey. question. Good and my thanks morning taking

about to importance the TMB. comment to back come of Just wanted the

comment prioritizing a just question, that the can obviously plan selecting about Can a be then As strengths to got you're in population on studying to roughly patient some against? for more you dose CheckMate of the don't that on primary we PASI but trying second and trials my Xx And, sense of compare these is that the are that dosing you on get regimens analysis? going that at strengths XLA, the updates, Thanks. you're dose list CT.gov were TYKX. scores Just confirm recent in next the least TMB. lieu the year, how think of the active you XX

Thomas James Lynch

you. thank Jason,

approaching it. couple So of ways a of

The TMB. about first talk one just to

well I a Giovanni how understand think Bristol-Myers we very in following TMB I at very example the important immuno-oncology as to helps the and R&D done is drugs how are pillar in us that science, a is of work Squibb. beginning, said great think that's how

we that we measurement TMB in think on I as TMB XLA, required different a you've seen, studies. In the have TMB introduced but have stratify based don't or study from collection, samples patient of in of number attempted we for our collection, XLA.

important that mind. that's think keep in I really to

think I So, an play continue important TMB role. to will

I XLA interaction not of opportunity at that good us forward is think very we forward, a with area number a on biomarkers seeing that, I but different to question that that one move is a will of exciting Think I second year. as the looking give think course an for TMB us. question, is hopefully extremely will TYKX that we dataset and think sometime 'til next your be that look we think and that's to of

it Carla know, the in the to again axis leadership testament hits what's kinase. of was this what as TYKX well real is As an the the chemists it's to Chico, is a they compound. oral do discovery and Bristol-Myers target were able is interesting actually Squibb unique axis; done, And the you at pseudo it's way both and the under that as interferon as IL-XXXX X Jason, Type very molecule a

JAK-type of that up we some with with inhibitors. side see the end JAK don't effects So the you

a and action of got side study. have to it's going X lead large course mechanism is to one effect think favorable profile, So Phase of only which we we a unique

psoriasis. this used, So, well-designed but drug fully do that's not it's trials have potential for going unlock understand how take in that reasons, more At we dose drug disclosed we going the to being competitive very have the time is be for the this before we will used. two think we to point

is bowel drug to addition, I it's we're psoriasis, developing into in Jason, in also developing moving but is to have could think we think just and remember, not studies it's be we're important important. a that active we think important inflammatory not we're an area – Now lupus that disease, also TYKX psoriatic for arthritis,

of and Now TYKX design, development we area I because area of really do we interferon has interaction this know but area an difficult very the well. in of Type of drug at the lupus be been drug with think X as should drug it's that looking an that

Giovanni Caforio

second, Jason, make future just first forward, important to I about an as It's of and thinking being endpoint a back TMB going XLA. just think our the exploring want of of being to clearly we a to me and many sure element for your go for clarify question are the that that studies let you about that's studies. shouldn't areas case be one as in we primary

John E. Elicker

Thanks, please, the Vickie? Can next go Jason. question we to

Operator

Next Research. with Anderson Wolfe is Tim

Timothy Minton Anderson

are to as shown hazard Thank what XXX that of to depending seems XXX. what going to ratio part non-squamous improbable with in show of X doesn't hazard in out ratio you. on starting make that me your most show KEYNOTE-XXX; me OS and but about appropriate to A To render talking good an trials might to ratio number XXX, side-by-side also of you the it big sort the first-line hazard can what really segment Opdivo relative are only number is. couple I'm program irrelevant where a was you pretty of comparison Investors questions. as that question

lung second-line So here need currently only goes good the other you XXXX, to ratio what question that say, asking the probably in And of Opdivo that's sort of PD-Xs types beyond the really, you second reality everyone is enough, in then so think XXXX. course the same. you're are confirming in period, it show support to whether that hey non-squamous such continues using all in population ex-growth is that the are or tumor that hazard Opdivo is institutions question do

we give of outlook, might such beyond XXXX today, any about you us the not and if guidance? when can comfort So get sort

Giovanni Caforio

Tim, for questions. Yeah, thanks the

Let the your question me start with about outlook. second

in three As made Opdivo pretty strong just quarters we're good we in year. momentum commercially good coming comments for company very remarks, I my And see for I and the about general, that with about a this based the said across-the-board. growth out January of I've feel feel on that in Opdivo I currently brand to XXXX said indications. pretty do having, the approved as on momentum we'll we in more but as about respect being good always in guidance the With I earlier, XXXX, do, the business. fact

ask me some your let well. question, the then of part Now give first will as first Tom to answer and Chris comments you

Thomas James Lynch

our you thank combo to I'd Tim, So, look both for seeing and is a question. obviously One of things. XXX your part of two we studies, XLA. the say results forward couple chemo

to patient. What spoke care going ever for know is and longer those chance or cured a we're about not a approach, the mention is factor their give patient. once, anything the occur oncology It's XX never selection. be patient I once, living one look some I or given and to patients forward predicting being about we time when something ratio ever that's in word them to to a are at disease. going As practiced did years. thing that's ratios. Never a the seeing event-driven XXXX. It regimen hazard those to hazard I'd you with was they never I in say

and really depth such when of really what duration, what durability immuno-oncology, you've matters treatment think it's in that's as see got the So profile so we I important. a to tend

which like at two in and at think something impressive our four-year that we and looking we're really three to I things that landmark four And, looking doctors of to starting at are that landmark year response think of setting. years really are that going Chris? the quite one in survival is Opdivo-Yervoy was focus on when duration to for data analysis durability standpoint. years I ESMO this We're a presenting be year, So four see year, melanoma. is from of research me, going things most with the we analysis, so proud were – at

Christopher S. Boerner

would hear is in when to to I landmark we importance similar patients a thing as I very that's hazard of critical. and both well be customers, about talk setting physicians to the Very talk in only the that think Yeah, about to as landmark. add absolutely academia interestingly community the ratios few and going we story

from a competitive an a commercial is competing depending the exceptionally lung thing we and It's think we've that we from that space to cancer upon in forward. standpoint have is area that The other be I just say opportunities a well. obviously that compete I know standpoint we'll would success had ready going

John E. Elicker

to Thanks, Vickie, Tim. Can we go question, the next please?

Operator

The next with come question will from JPMorgan. Chris Schott

Chris Schott

Thanks very much the Great. questions. for

for does Thank the you. a prior confidence that here? My views here. as trends at change So do seeing was market think there you probably Opdivo percent of frontline? be to to a that question first we've in the two bit Just your from TMB we give interpreting PD-X's then still going you what are we all versus see very biomarker in different not? why back predictive coming PFS high are versus guess to ramp TMB. OS And and patients power Maybe trends an any in its on us that importantly, PD-X lung. Can and you're low more update the How XXX? if do how time update change second see seemed now a and TMB in of seeing that second-line? evolving? second-line just saw populations not, basically KEYTRUDA overall size you be is more I What had second-line for to your the And

Christopher S. Boerner

that Chris. me Let question, part take first the of

pretty are in of for discussing quarters. couple much dynamics the market been second-line last we So as have

share market roughly XX%. is stable second-line Our at in

In we with are line in terms have patient eligibility, been very dynamics forecasting. of these much what

in decline the in what both agents of of and monotherapy just that the as That second-line for In believe gradual in second-line timing the the somewhere outside range XX%, since the out in still in previously. XX% XX% roughly and to continued approvals. eligibility to think a consistent the be that U.S. PD-X combination more of approval given seen with setting. have We to U.S. said the gradual frontline going patients of that's we I-O are eligible level we continues we

Thomas James Lynch

we And, little take happen explain the and what TMB bit we Thanks. week or just about the me second – past since to the over a authorities. interactions Chris, let saw week with since or you two a reported

back to think let's So TMB.

I-O cancer, reason and surrogate work in did to looking TMB? to scientific in general were We And got cancer how our in we because as know, So you in marker cancer immune think to a get specific of for drugs we be understand TMB TMB reasons how lung response specifically. explain could even better. or that that those for that can possibly could of number increase both can patient a TMB I new identify and neoantigens the are increased potential groups antigens be or do driving

we setting. specific in United and for those that request authorities hierarchy four that three resulted of response an didn't treated in that TMB of look that At in by people the ESMO, result, a was a survival we at reaction look did initially survival did And around. when days prospectively and showed those that's and statistic, why I've a specifically was And over setting. at submissions the the the at there those look Opdivo-Yervoy the increased all Agency, the happy or to improved not asked the European asked they know this both at But we TMB integrity high see survival descriptive Opdivo-Yervoy to descriptive look time designed is and parts rate, to to Opdivo-Yervoy our we you very in in with evaluated, that advantage that and of then past us found shared in the the showed survival Agency, the for the to response progression-free been group at first of in the States initially. in that we survival statistically at again the were want had the with trend So a had XXX patients didn't We at patients look because to the patients. the favoring statistic survival we high group careful not you look who in European overall X Europe. reason clearly look course, to trial, many why very Part and TMB-low treated initial in that that remember protect we be it with

this So that's group response are the PFS patients clearly data? that rate a think the to I for endpoints show. is was those important and from TMB clearly, is and in of what what TMB you can important designed trial high predictive an conclude prospectively and first

it's and when our of competitors that find academic and some has the cancers, this look definitely attesting depth, TMB that generated in you at LACE have look patients you the to from some look the think one and resected that do that think we we just data also However, conclude you as not TMB data higher survival to I survival durability it's at least part we progression-free high at But higher also can is that lung certain back to in we're that better know a in Chris, But the the I degree. And but probably magnitude if and thing of is important, TMB, of the benefit, early that's in prognostic studies and like meta-analysis group response remind well everyone to of still that process. from rate patient generated, overall at population. the benefit better. of important, again Chris, duration

to to treat cancer. to continue TMB use work science we as to lung to understand TMB the and try We to we'll better relation how biomarkers how use in to will to understand other how continue follow and

John E. Elicker

we Thanks, please? to go question, the Chris. Vickie, next can

Operator

from next The Umer with will Raffat come question Evercore.

Umer Raffat

just be forward the to you indications Hi. gain Thanks be more secondly, therapy not, much. how granular on if to with much much. how today given it the really or all Thank XXX for when as and well XLA a very taking you and first, so on a much indications as should if there helpful color on depending the Maybe sales get and discontinuing any consistent my behind we as And on sample more wanted would bit It years, this breakdown what a the Opdivo three first. questions can be get progression. topic, how that question. from investor changing lose, changes? fast thought it patient did are criteria bit size on the relates Will process what or

Giovanni Caforio

you, Thank Umer.

So, on some next answer and XLA. Chris, and year can why business don't into Tom you start the describing the today distribution growth of then of our

Christopher S. Boerner

for question. thanks Umer, the Yeah,

you sits the start me just by of as giving distribution it let today. business So

XX% Ex-U.S., that XX% on see business the renal you about be based that tumors. roughly Opdivo, around then difference have XX% our is of set of other the a to then be mainly a remainder melanoma will you and in lung indications spread versus U.S., going different in of ex-U.S. and U.S. is So is in will the across for

melanoma. going of the renal percentage, lung XX% keep and XX% got larger is XX% things this of to is is U.S., the be is in outside about A a outside time. to U.S., around then in it's So, mind dynamic we've over couple of

example, percentage in outside you Adjuvant for renal a business in frontline just have plays U.S., result indication. the an the in that's that's role melanoma larger important the of launching a U.S. the So of obviously of the cell, U.S.,

continued the U.S. So of what going in the see you're likely is a to diversification business

adjuvant markets U.S. You'll as likely like lung more the business other business decrease percentage in see get the in of to continue of outside cancer we the melanoma.

Thomas James Lynch

Umer, address I question just XLA. And on your think, to

a And along there – patients help was you things, that could the that designed. uncovering if who can it and couple more progressors, let's XLA, are of I it's is early there's the response. was best a immune about stimulate be with address It chemotherapy. to really think possibility are neoantigens designed think, of help chemotherapy benefit to plus neoantigens generating why immuno-oncology could that theoretically that or and very an bring chemotherapy drive

opportunity as give was using see. also us at thought we the to might cycles of two maybe while XLA just side an benefits maintaining in we thought we us and chemotherapy patients of an chemotherapy, look gave to when some what So it effects designed chemotherapy the reduce still we also of that opposed related ability to that cycles four

desire, hundred by this very of the going quickly very, of adding and so accrual were accrues know when And had saw the our you an looking patients XXX what it the engaged at was we to that where extra rate throughout we really very, of increase centers biomarkers. really great trial couple As a XLA, be with very we number on was specific to realized fast, that and accruing we able world. to it was following optionality drove

made we so that XLA, And increasing thought sense. that at the accrual point

increased the is really we of that that so that trial. the reason And Thanks. size

John E. Elicker

next Thanks, Umer. the please, to we question, Can go Vickie?

Operator

Phipps Matthew go to Blair. William We'll with

Matthew Phipps

taking my Great. Thanks for question.

Just can I some in event-driven But can you and long? melanoma, really of decrease two of other you similar you different presented kind you've had saw trial, CheckMate-XXX and and say why then AEs regulators? submitting changes there, there also taking Do so delays overall study. in recently don't to it's this, of on continued one CheckMate-XXX know has an also us of a through readout ones, (XX:XX) data quick with dosage walk the that realize the And Nipi-Ivo in that's plan but survival. on what I in

Thomas James Lynch

have particularly some So his to What there. regulators dosing we I guidance, comment them make on CheckMate-XXX communications firm on think that don't how yourself in melanoma question time. you as to know will understand the until occur interactions We to have that process, CheckMate-XXX to want active wait I an believe say just and the look globally until compares setting. that It help with number this Chris I'll Hepatoma. it will kind the of this we is look to It's a is soon Matthew, about be have some flexibility forward it say seeing able that is you doctors, And let that to just takes we obviously comments. data. me a couple and them. setting. event-driven Opdivo us you again, gives view in events setting and sharing we the and in of forward to as comment we in with in agent some know, we may answered of offers an We TKI dynamic to event-driven do and data and optionality from

Christopher S. Boerner

over this. you adopting low-dose a us. going see we'll Matt, and see wait benefit/risk about shift on information It's in wholesale be Yervoy so don't the what plus to but physicians promotional bit Overall, to now, we to Opdivo could with see of see I'll increase far. to important additional that's couple alternative for think comments something in of certainly going the from is think the safety not XXX. dosing commercially, Yervoy. a just data seeing on metastatic We're dosing. and based we providing the combination We encouraged of that on some the implications The in make how dosing melanoma obviously have anticipate of time, physicians be a we're study

Giovanni Caforio

that that We this have intent practice. is in from trial. clarify let do a me and just with Yeah, not really questions to physicians medical study inform registrational

John E. Elicker

we please, to Vickie? Can question, the Matt. Thanks, go Great. next

Operator

Fernandez Seamus Guggenheim. is Next with

Seamus Fernandez

the Oh, great. for questions. Thanks

study cabozantinib Opdivo guys Part XXX how in a just, study the that you the of that stratified from can likely may Yervoy then update the patients Just itself half couple your plus combination? plus timing is and the B by how think Tom. bias? just Can levels? the understanding second question my is you are confident XXXX. how distinguish given you this just us this the selection risk of own complete it's And Thanks. first Tom, just to PD-LX you Opdivo here study confirm have for successfully include you on will of And different PD-LX-high

Thomas James Lynch

couple let's So a things. just say

I of you think Part XXX. actually meant what was by part B, X

with we histology patients we forward an event-driven enroll enrolled regardless a when histology seeing see it broad we shows matures. patients regardless and PD-LX to when data status, that of data study look enroll you what we'll know, a that to chance when and and that have and study, that's As into of

TKIs our very TKIs, a can reasons of releases one combined cell of that's as one response, be interesting forward Opdivo along of advantage we best the we we renal presented rapid think with having as TKI data Opdivo seen year look have potentially we competitors, approach. a In approach terms and early competitors, again, we cabo of press study that from data cabo with that that using some X-ER we've well. the of watching And the the think at TKIs saw the in and is mature on and work carcinoma. and seeing you this to renal ESMO that other with know, of cell With

you that's it's you might year, bit be little I'm a suggested very again think had event-driven to it pin next to down. be be than that, as able it's later and difficult but Seamus, know, going early think, probably tending I to to that

John E. Elicker

next Seamus. question, Vickie? Can to the please, we go Thanks,

Operator

is Baum Citi. Next Andrew with

Andrew S. Baum

you. Thank Couple Eliquis. on questions

interim and and Eliquis renal planned how without trial market a very First, share given share service in opportunity for or much for with details see risk a competitive to do then either the to segment Medicare? ongoing without second see volume cabozantinib? version do NDC any fees, second, quite just finally, a you about need that Eliquis you analysis code And quickly, then an can And rebates you launch world is? under how

Giovanni Caforio

a just from couple Andrew, me. comments

I clinical trials would So generally Chris competitive you to second, coverage world. Eliquis say, about in and first a analysis ask me give on we of of don't additional to ongoing all, comment we interim access but let currently launch performance forms have just plans perspective Eliquis and don't a

Christopher S. Boerner

thanks utilization that targeted also be Eliquis for management. for think important it's mean, the is class been for to I the in a space is that differentiated payers. will but so a that's is this Yeah, very important have said, cardiovascular continue you what only strong physicians product, I which increased see patients been for question. we not a is advantage and and has that That

actually That in demonstrate performance relevant are patient to stroke access risk so result a data populations superior in it carries gross-to-net And, we've as those efficacy of respect We've as access both leverage in our we've a in payers. able Medicare commercial a improved is B you've to that reduction to access strengthening payers well and that with able to seen growth as been that, particular continued what real-world but really our positions of to the historically Eliquis have in and for with seen We share both across the through and terms in of position. of seen some and channels plans part both an bleed exposure revenue. Medicaid of brand's strengthening year-over-year.

John E. Elicker

please? question. for next we the go Vickie, one, can to Andrew, Thanks, the

Operator

to go Steve We'll Scala with Cowen.

Steve Scala

you, Thank questions. I have two

secondly, in been to The I'm in could hearing Nektar-XXX your first-line the which you. did ago. resolution not. renal trials the CHMP III months has and how Thank changed Phase then And, trial a CHMP's lung just eyes? be impact decision? anything now And cancer, does deadline CheckMate-XXX will when occur had another Bristol see needed start rejection expecting quick has was of quick data, which wondering, but three we if also the a

Giovanni Caforio

Steve. you, Thank

know, no many, Let really renal. at on are point the own What regulatory are our can is has question we me its European through comment authorities those Every are is CHMP on team as procedure. one going application. There of the of with the there say this ask you just timing. every one those, working and I the

Thomas James Lynch

Nektar-XXX about Steve, question for cancer. thanks in lung your And,

why so mechanisms. is with to and are think at it me So Why when And let down three things. Nektar-XXX partners our closely I that you a are we did comes validated just look couple start Nektar? working at immuno-oncology what there by saying do we

agents PD-X the clinical to IL-X. worked opportunity together you've how hard this opportunity. best to to put unique was we pegylated form got a to develop determine in we And access, of a cancer. Nektar with and it's a agent, this And the got You've use think them you've these IL-X, year with to very of partner CTLA-X got number trials

terms the more is activity with certainly T-regs. some PIVOT-XX I-O-related the change immuno-oncology-related, prospect terms and an profile. And, you the to certain has but to Nektar-XXX run study also the may other of that of remember, you by shown Because how uses intriguing effect one in of need peripheral Nektar more perhaps data, study and time we that is stimulating side premise by certainly in of course, safety interesting very it's that data be as which So profile a pegylation setting. the process in

certainly from and that PIVOT-XX design And to in justified be some from closely So to study. seen of in and the cohorts very And cancer, certainly follow types at continue we melanoma included cancer. tumor next. saw lung the trials to in PIVOT-XX looking which data renal going cell the we're bladder melanoma, you've determine are we

understand from are to sure because that one sure how early that the are we help our best drug of and the think to make is most we be us are I use the trials this drug, optimize in to development the to things make going they perspective that process able its it's important want of done, potential. trials to therapeutic

John E. Elicker

we next a question, Thanks go lot, the Steve. please, Can to Vickie?

Operator

Yes, SunTrust. to we'll John Boris with go

John T. Boris

on taking the and for Thanks questions, congrats results. the

then give Eliquis. There's may types? breakout obviously renal, question Yervoy. a you by relative renal. are to high high Inlyta patients to in The what of question might And the last melanoma, do percent First, use on second of Can inflection tumor used? to on area intermediate and In an be in Yervoy. MSI-high increased with intermediate lung, to where plus have has PD-X use first-line it the other

You valves, that much you used especially growth? XX% with lower go but before patients How still indicated you in can exhaust warfarin go, of number pretty it's heart Thanks. how low can volume. extensively since

Giovanni Caforio

John. Thank you, Yes.

of the question? don't parts So, Chris, three you why the take

Christopher S. Boerner

question. So let's start with the renal

renal drive to grow. the roughly continue very question the our share population. roughly I opportunities frontline in and where our way, mentioned to renal; as your There we prognosis see sub-populations on are continue is in indication to question within With renal. improved to got poor focus utilization is frontline the the XX% that's XX%. that We've to can we frontline been warfarin. good respect by of of who in in of continue patients And renal, percentage to patients is around and So an in intermediate momentum performance XX% terms

mention, where still the of roughly garners U.S. both continue And still it's of is we share ex-U.S., warfarin ex-U.S., XX% use to if U.S. you significant and you of share, warfarin markets new in and As roughly in got see the total of XX%. warfarin terms of utilization. look XX% U.S. upwards you've in

not we can warfarin at only can in warfarin to look as things from you are take price, the the The if drive also profile like the NOACs of continued as of believe believe other as we efficacy with the from but use of continue we well as down. that warfarin. familiarity continue well constraints safety warfarin be So profile going to Eliquis, to but have on to we U.S. utilization share, key

Giovanni Caforio

countries – grow good potential. the clear to work strategy in are third advanced we leading would the NOAC, has to business patients, the point for over for then with market the John, first reasons strong I would opportunities or the poorly erosion which is focusing other say, patients our Eliquis I terms of we and against most is treated are our disciplined the been moved undiagnosed very, and market been and to then thing fact And opportunity of on in I warfarin the performance at say, was continues and believe ongoing have very many that our with be important. And there on we've is, beginning time is expansion one the total are warfarin of very that opportunities and that is priority to where different expanding looking

rest As there. you sources use of The said, small. Yervoy, melanoma and very the is renal are really the of two Yervoy

John E. Elicker

have Vickie, we I John. for Thanks, two think more time questions.

Operator

right. All

Morgan David the to with you. next Stanley. We We're open. from line unable will take hear David, is question Risinger your

just come button. check Credit with Divan no I'm next will Vamil for Vamil K. Credit Divan questions. mute my question, - (USA) ahead to your and sorry. and the go Suisse. LLC Suisse you David? Great. Hearing If on could taking Thanks Securities response, we'll please move that from

hear business I to Opdivo sort to on a development, get especially bigger something all question to question Thanks. happen, how ago, later feeling you're diversify one the something focused in urgency and would pursue smaller there up and business know just afternoon the to more from likely quarters perspective, know to love terms this debate a to things just thoughts some drug happen, in on think both just to of then personally said maybe following the urgency as of how Yervoy priority size, relative President is, is on. we as was And development what to it's maybe one, likely the get higher-level; but opposed to the sense, I'm been have going Giovanni and from maybe the pricing. the you may around and we're company? Bristol should desire are expectations where updated you're for what around second from something and what also be on your the trying and investors? a I related not focus I evolved two, a earlier just a the So now change few has to

Giovanni Caforio

Vamil. you, Thank

make a well many to important truly and types remain we been aligned operate year in sense be the the development very that business medium business at obviously with it is think that long opportunities that and can is very there areas and we've into company, back opportunities strong it momentum momentum have where of beginning, They obviously at always strategically potential and of look significant put couple context, with perspective we and competitive the in where priority the I where of is business. going scientific markets, looking In a areas us a an financially. develop presence we next today development my on at growth expertise, priority we to which know we So, Stepping needs things. of back transformational there good I are going as today already valid, has the term. the and We for acknowledge, science. lenses of number to about a need comments when from and

is continue will of medicines they to clear that that a many being that really elements view couple changed important internal early things. BD, From in point on have it's of but be the must difficult the as policies have opportunities focus is of that there the my It's qualitatively discussed patients in by it's important, to So, very and past, pricing put access in perspective, not our I a a they're how a terms predict for and evolve, significant the of focus of said. I administration set context perspective, themselves implemented. to the we're need what's the of very both the serious of policies way From diseases. think

on comment the with in a and important very to industry, benefits an progress order really to forward that But policies company for open we think are very the it specifics thing that very issue administration to patients. I new on because way really that early. in as important dialogue address the to it's it's me difficult of is important is is as affordability, and which patient And policies to cost a focus us. out-of-pocket third

John E. Elicker

last to go we can question? Vickie, our

Operator

Yes.

Geoff from come will ahead. go Barclays. Please today question last Our Meacham with

Geoff Meacham

question. other guys you've strategy added have and time it guys. though including you to mix, mornings, IL-X Tom, I-O, Good takes some to Thanks doublets, the combos optimized III. these many on your before in Nivo-Ipi but the optimize for Phase

few color question get may or my out take viable. they're Tom the and if figure urgency a So, years You last doublets your then or these I like targets has over to advancing at changed And be is, for the or more STING Giovanni, use time? OXXX it rate wanted even doesn't hurdle look science to in question, a and it TMB? on in more to validation need for enough experience the sense the appear context view that It more your in from regulatory the regulators Thank TMB or you. – but your the community? widespread Is clinic is KOLs, review. worry mature on the to

Giovanni Caforio

you. thank Geoff,

Let first. me second just answer the question

leaders, the you can few to question combos. we on Chris comments ongoing thought We quite and then TMB a prescribers give we're not and of what with Tom market. and answer perspective think we next-generation on I can on the your hear Chris comment some regulators. going made and interaction from

Christopher S. Boerner

hearing. let on the the we're just of at of me least TMB respect and give to Yeah, sense you with happening what a TMB what's based use in interest

rough XX% in but been if slight that's tested and a now, U.S., of evaluable TMB status. is look testing and uptick you right So, the who that TMB there's around been cancer, patients in frontline the on a lung percentage have an have

seen the also you prognosis TMB patients in the TMB seeing could get for a drugs setting. TMB a of in and testing testing, in of by when It's targeted ASCO. biomarker. be driven the you do lung being about being increase such this specific you that choice. in because to at And telling marketplace segmented physicians example, but not number We've get interest interest results, for of a right clearly is to interest a you've more TMB I other AACR physician seen now, also only be you patients. the consideration you in continued setting. The that biomarker-related you something informative market. is why, in as As frontline think specific important us data bit back for going about in increase able are continue an and that's also, certainly That's is to becoming to going PD-LX think, seeing part why It's were have rapid cancer the to the in – what dynamics a

TMB. that plus continue there you Tom? as available testing which interest becomes potentially uptick for in an to think Yervoy, an see plays like have option wait will data of to is patients that could more I high so, out be And and as and you Opdivo an obviously, with organic how have products But, we'll see TMB. and

Thomas James Lynch

a about make triplets It's can and, talk say your a think things. even for something a I'd we and difference. we Jeff, identify doublets obviously gosh, how thank quadruplets questions. that you lot in thanks couple that Chris, and and about, lot a do terms of, we even

to Saha to remain Cambridge our become needs what continue we in science Emilyse is in first The (XX:XX) look field to Saurabh patients to in grounded why help just join doing the at up we're recruited resistant. Cambridge, and

learned be is doublets studying I most And the of combinations the concept make which effect Phase which can make in that and resistance drug. thing isolate going the extremely doing that of to other think beyond X most control so of think understanding PD-X is I a got sense important you've randomized we've sense. CTLA-X the where the new good studies the Phase X the arm and importance you

be are in with we've to think doing got this our is be impact an the And new of to a CSFXR we're at great being and being that's to to CSFXR, us some randomized example that what added, that I of area CCR-XX as Phase are good going agent able where tell look the relationship isolate pancreatic examples well. that in able of X's (XX:XX:XX) cancer.

is I important. urgency your think, Geoff, concept extremely of

screaming and areas patients need When look CCR-XX (XX:XX:XX) not where at think were it's innovation I that's it's patients new options. looking that options. – we cancer market MSI-high. and are at if you are colorectal the in pancreas, for in and demanding CSFXR, These are

is think at taken end your about to science. very the question the going it's be fundamentally I So urgency but well in grounded

Giovanni Caforio

you. Thank

opportunities there's answer John we of So, continue business, strong obviously growth. want for for the some Thank and in in opportunities longer-term the and growth with thank to to his being performance, good closing, on we for are I discussed to in team XXXX the available a call, momentum your you. everybody quarter good commercial and had questions.

Operator

does much. very That may you conclude thank you And like everyone today. conference for your participation, thank our I'd and to disconnect. now for