Bristol-Myers Squibb (BMY) 26 Jul 182018 Q2 Earnings call transcript

Company Profile

Participants

John E. Elicker	Bristol-Myers Squibb Co.
Giovanni Caforio	Bristol-Myers Squibb Co.
Charles A. Bancroft	Bristol-Myers Squibb Co.
Thomas J. Lynch, Jr., M.D.	Bristol-Myers Squibb Co.
Christopher S. Boerner	Bristol-Myers Squibb Co.
Johanna Mercier	Bristol-Myers Squibb Co.
Gregg Gilbert	Deutsche Bank Securities, Inc.
Jami Rubin	Goldman Sachs & Co. LLC
Christopher Schott	JPMorgan Securities LLC
Olivia Brayer	Barclays Capital, Inc.
Jason M. Gerberry	Bank of America Merrill Lynch
Andrew S. Baum	Citigroup Global Markets Ltd.
Alex Arfaei	BMO Capital Markets (United States)
David R. Risinger	Morgan Stanley & Co. LLC
Steve Scala	Cowen & Co. LLC
Umer Raffat	Evercore ISI
Vamil K. Divan	Credit Suisse Securities (NYSE:USA) LLC
John T. Boris	SunTrust Robinson Humphrey, Inc.
Matthew Phipps	William Blair & Co. LLC

Call transcript

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Operator

Good day, and welcome to the Bristol-Meyers Squibb 2018 Second Quarter Results Conference Call. Today's call is being recorded. At this time, I'll turn the conference over to Mr. John Elicker, Senior Vice President, Public Affairs and Investor Relations. Please go ahead.

John E. Elicker

morning good and Jake, everybody. Thanks, us Thanks discuss call to the second for quarter joining our results. today on With me Lynch, this CEO; morning are Giovanni Caforio, our Officer. Financial Scientific Charlie our Chief Officer; Chief Tom our Bancroft, Chairman and

We have U.S. Chris prepared and who for Boerner, will remarks, Giovanni as runs and our business. Johanna will Q&A business be and international Chris and runs Charlie Mercier Johanna who our have then well. Tom, here

handle we started, language. going safe Before to the get harbor I'm

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

Giovanni Caforio

you across speak Thank very quarter everyone. performance you, morning John, outstanding today company. the about a to good proud to I'm second with and good

announced of Monday. I Gordon, Before want I we acknowledge and talk further, on Murdo contributions to whose departure the leadership

with and Johanna, teams high-performing know, developing Murdo incredibly organization, who us leaders, talented Chris you build including a and today. commercial As helped are here some

Officer successor Chief position, a will and in be Commercial finalizing very for a we We strong the shortly. are

portfolio. execution quarter. Now, our The reported commercial Eliquis were discuss franchises let the driven our and key of by across and strong results in Opdivo today me we

Eliquis the a environment. and As teams a highly superior driving I in at At saw continue focused beginning we year, the set for about Opdivo I growth commercial deliver spoke of opportunities level that dynamic a mentioned, and with our future company. the competitive to of

first market Now, pleased which considerable the have expand, the exceptional we half, during we I'm of delivered clinical see are. at increased quarter. the room saw the that Eliquis, with With where it to benefits for I performance, based adoption Eliquis end with the made leading NOAC. continued on very the

oral Opdivo, multiple for continue a an forward, Eliquis Looking is as to warfarin earlier anti-coagulant establish With poised Opdivo of really confident be Eliquis lines in important and multiple in broader foundational in the year and company. to I therapy this tumors. to further growth opportunities of driver will I'm of overtake described the class, important number

in some these We have made in good a and more these I'll focus areas, moment. of on progress

setting. For first standard renal reinforces on example, saw in the important Yervoy role to be role melanoma, builds line continues the important. in cell earlier line now in is adjuvant success this and Opdivo we of for of which care therapy. The our cancer lines launch Opdivo strong of uptake continued in Similarly, strong in second of the

As renal, colorectal tumors, of now you plus Yervoy combination melanoma. know, is approved in and the Opdivo three

and of U.S. the rapid strong the first this to uptake of RCC survival of patients is the in uptake a result by we we growth interest Yervoy during QX, and demand The We of we the that in quarter In has strongly from the EU seeing and U.S. dose the first our a receiving Yervoy. will that with compelling Strong saw the we this fact this Q&A. CHMP more driven will medicines Opdivo negative strong benefit opinion a our disappointed are of to Knowing just renal. in provide Tom opinion return we in to very learned pricing population increased under execution the importance by share for color re-examination I'm line a RCC, pursue process. commercial have to regimen disagree line plus low patients, demonstrated compared in not regulatory can be launch. driven this the the overall with results.

Now, is the for we've topic affordability, on all which pricing us important seen the and and developing discussion industry. an for

As addressing the to with supply working with We're any issue can call. on specific closely you We opportunity very in improve the the system a we the on patient affordability welcome chain. have following misaligned committed we a administration. the this focus company, answer questions to incentives and in are and later

and and the the at ASCO. scientific cancer that presented lung I-O Yervoy mutation of in with plus in under see particular to there Opdivo applications more broadly remain define line cancer review. data or In agents. significant Europe the lung in in was in advances our I TMB a role in U.S. discussion the were further and tumor its believe evolution quarter, play During with treatment TMB first pleased burden the and regulatory as accepted will was for immuno-oncology, we value

pipeline. role that I-O forward, our the biomarkers of of is in an strategy we continue Going investigate across to part important our

we very ahead, catalysts. had important some Looking term near

and work HCC, readouts XX lung in cancer, by cancer, diversified pipeline cardiovascular fibrosis. the excited we important looking months doing data and immunoscience the disease, next with neck. lung and we're to forward cell and Opdivo, for our six I'm small non-small head gastric the For are also cell progress in to

XIa and compound you know, moving is collaboration we with forward. As signed thrombosis our a recently that for Janssen in Factor

for right compound weeks. well of other Europe I'm range psoriasis the strategic the present we in on the targets. by believe is studies are closing, few we start next where compound. We we TYKX for believe are TYKX and opportunities to in and expect we an promising executing This exciting data focused not profile future. encouraged is mechanism the In in registrational very but in I the in immunologic a only our disease Additionally, September, particularly of

investing I'll to that, are turn we're good growth. the And and over pipeline our about very to We making. I it in With commercially drive progress feel Charlie.

Charles A. Bancroft

morning, everyone. quarter our was demand key outstanding brands growth. strong two by franchises, sales The and for Opdivo. gains revenue for increase driven We our Eliquis prioritized an in growth Good highlighted of substantial delivered XX% by

including Let XX me the start top with during already growth France the which UK. around Eliquis, in number is delivered other the in NOAC Eliquis many U.S. quarter. and one XX% and important the world Germany, markets the

said, expect As warfarin U.S. and soon in to overtake the Giovanni the we OAC Eliquis leading become

prescription further signify to see that NOAC expansion also continue We trends class. of the

U.S., decline it as currently total of that XX% nearly further warfarin of in the in example, prescriptions significant but about expect usage new only has For of we prescriptions. share half share has

for to cell a delivered we expect competitive first class during In substantial highly maintain in we the growth its leading expands, I-O with As franchise, U.S., adjuvant position and uptake driven going forward. momentum growth where our the to XX% NOAC usage our is new environment turn Opdivo in I'll line Eliquis quarter. indications, growth this by melanoma. renal the in primarily now

is some in Uptake our new dose rates Opdivo U.S. For launched seen low roughly the of up adoption share where expect profile, already of quarter execution we've close line expected share. the stability We treatment opportunity patients, dosing treatment seeing the has market, seen of with line strong for driving exited this it the option, remain respect four-week Yervoy. been an longer making the eligible markets. XX% patients. of period adjuvant for that second With important early melanoma this the leading a cancer, rapid contraction regimen We're are just to first line our the safety in in U.S. the I-O renal compelling also Opdivo second with for the having to of we've efficacy of market. April, has despite line Having remains across signs share coupled stage very size Opdivo in I-O Outside us. XX% melanoma key cell, we patients indication also and early strong, stable, the in lung second U.S., with lung and

for opinion. secured and are melanoma, also indications adjuvant most the current have in for preparing earlier launch reimbursement in given CHMP We positive the European we year, the

to brand, this and in Opdivo both year in mind, With continue growth view trends these as a XXXX. we

Yervoy sequential of quarterly function to factors. a This returned Giovanni three has is growth. As mentioned,

Firstly, we continue to first in see melanoma. leadership line for Opdivo/Yervoy

first through shift Opdivo new uptake line with of been to now driving the also adjuvant coming Yervoy lastly mono and in to use encouraged renal in base, worked We've we and about the see have prescriber importantly, cell an prescribers. of the renal in renal regiment cell. from melanoma, the of XX% Secondly, rapid very expansion Opdivo/Yervoy

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

last year. quarter gross the roughly QX. negatively was offset product unchanged by FX favorability favorable compared QX is margin in gross is mix, impacted Our to FX by excluded, margin from the Once

this has other to in As I've recorded the increased and pension the year, expense in described income mainly past, due diabetes now other of income. benefits net recognition royalties and

the of end royalty the loss be America of the to Erbitux North forward the the of second this Looking by year, line affected half at will in QX.

And U.S. to we drive investment our R&D. Regarding last disciplined finally, as favorability largely in of with to remain in our rate, quarter the the is to due MS&A in the reform. in regard to tax OpEx, facilitate impact our to year efficiencies line compared spending continue we tax

growth a top our in continue to approach, $X.XX. provide half range increasing Based based priority balanced our comments and this trends mind business use year, as of expect take the guidance. are With capital on to remains to does the Turning mid some in we for by dividend. strong we digit in where deliver the business, guidance sales to in to on development a EPS of range. high-single non-GAAP we our commitment business allocation I'll now our capital, revenue strong the on first performance

in deliver we to And believe As drive exchange future Eliquis positioned Opdivo continues strong we with growth. We disciplined the guidance very always, the franchises value. business take to to be resources well had highest continuing the opportunities. foreign we advantage lastly, current and of areas To a close, to prioritizing our quality our will believe that remain rates. quarter assumes our

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

John E. Elicker

I go Charlie. Q&A please. Jake, And, to think Thanks, we're to session, ready the

Operator

Gilbert We with will with Deutsche Bank. Gregg begin

Gregg Gilbert

more Tom, you and on settings couple. high TYKX bones with offered on program, start it some relates the to meat talk as there A decision. obviously, the expound disappointing there on situations? CHMP read-through other state. Can to put that you and since secondly Thanks. was in a And could it disease I'll Yes. the any other that bar

to to there? forward that, Tom? than Or spend in is a the it Thanks. pivotals. lot and key more of route the Is of made money You've delivery resource decision hook going there

Thomas J. Lynch, Jr., M.D.

your you questions. thank Gregg, for

Opdivo/Yervoy key low not the or from Let a And And well the we XXX. their had not when we given of setting. worried we And they CHMP. after with actually we the on were did the contribution designed make demonstrated that important something are strongly sufficiently to finding. that an learned me or start We sense be basis to opinion doctors activity finding patients world, renal And arm a this off not opinion whether in want with the it this. we make about discussion feel grant agent able study we to single talking was felt regimen, And the sense. that for leaders about they extremely of offered study, the agent they did that seen. establishing considered their around combination And really about would treat to seriously just single yesterday their negative is discussing going precedent believe a had the components with.

with Gregg, at I-O believe we says the and Now, within has real asking read-through else really that this we tumor we for our have anything with road a types our program. point. parts which to position not our a that here the to other able of CHMP I to believe to CHMP designed think a I'm important discussion other any look re-examination down this to is about this don't application. the it's are We opinion proceed that compounds we're reaction worried that regarding forward broad note to any studies and market going

what gone just that's and reflects I So work question TYKX for compound for really we've things has the excites in pseudokinase. could of very is TYKX members proud Squibb. And of can Squibb. And of is be Gregg, picture Bristol-Meyers done your is discovery here, JAK TYKX. the This our And and pseudokinase think that TYKX and TYKX that is not what of about to mean from it's been other what Bristol-Meyers potential different of able that a really targeted discovery that in about the me second clever group the ahead chemistry more inhibitors not regarding TYKX I family a psoriasis. the targeting been at I excited actually that very think, one some TYKX best makes we've do

program the presenting of details a the very (XX:XX) say at has going know, data and and I'm in sense. European Dermatology to this except at into a same of X moving to the makes big convinced make that impressive in publication forward that us will with time. September and impact this that (sic) of the Venereology the a journal be we'll not data think data that be it we Phase market will a certainly you As forward [Academy] look in Society to go we year

be oral who this thinking think about think drug psoriasis. particularly I it appealing terrific I just it is, again, make I think, the one would it's biologic of of attribute patients it And to a doesn't pathway. and what options exciting a Gregg, target finally, would a TYKX convenience makes like in are

as as in the pathways think, I inflammatory possibilities lupus exciting. both and You well are extremely interferon. disease, bowel IL-XX/XX get The

as So Europe data fall. that forward and look for you have sharing with lot a in TYKX we of enthusiasm this move we forward to we

Giovanni Caforio

Gregg, this Obviously, about for just back second is as renal in Giovanni. we've to received. disappointing Tom it's that go to said, a discussion news the Maybe Europe.

which and happening, that want put step see not into Charlie number as does patients have. think of growth of growing just our I to brand for change this go next year context the back stated development, Opdivo it's significant I is this opportunities we a clearly forward. perspective important we still a there. we and

John E. Elicker

we Thanks, the go Jake, question, to next please? Gregg. can

Operator

Rubin, Goldman Of Jami hear from course. We'll now Sachs.

Jami Rubin

you. Thank

will how this renal? may if line commercial about sort Just about the could renal? lung this revenue for decision, perspective, to the just et about a Would the maybe, in opportunity seeing the of market. quarter know incredible Help And the I don't up this to opportunity we the thinking been, to was lost, think could opportunity you resilience should opportunity have about but what a be, European second that, us on in or commercial about follow cetera. or Johanna, that for global we're explain in also how Opdivo think the think still, from Europe in just of

much from the said, much. two the of Johanna, at just you think our moderate you you really You expecting. explain feedback getting XX% that very Can than is expected XX% what what a physicians? conference decline and over why next years. a decline more Street That I kind are is only Thanks

Giovanni Caforio

This you. Giovanni. thank Jami, is

line. perspective Chris the then line go So back the And to your let his the evolution market. on let not cancer in to first going just, you renal me in able about the to can and between obviously lung on of But be further just dynamics elaborate regulatory first me ask we're question second to front. Europe give first Johanna

Christopher S. Boerner

thanks Jami, question. for the

just obviously very we've seen Let that by the with It's of across Opdivo really the with start markets and indications. been saying outside me across happy we're U.S. growth

As think we tranches. about way the business it think two I in forward, is about really going Opdivo the

base our continues So Opdivo. first, with strong to be business

stay the XX% to stable to with relatively lung at U.S., roughly shares XX% market We the second line expect cancer outside of range.

as impact XXXX notably PD-X While number we chemotherapy the in won't line, dynamics then earlier timing frontline that fact see the outside likely of cancer the access in line didn't for we a reasons, we market U.S. in the that into expect until do well of the lung of of first for to an and as regulatory approval first well see line decisions approvals second

to gating beyond the starting cell. Yervoy other Opdivo BRAF as melanoma decisions, more with U.S., uptake the line with front such obviously population. renal remains based new there as such additional disappointed plus then lung of opportunities We're the And and in opportunity see potentially be lung the of think longer in continues some with growth forward factor access near have the in the the lung well. opportunities know on cancer outside And we'll for we growth cancer then opportunities for optimistic the look tumors then the term, Opdivo decision we business have notably await cell. there access interactions Metastatic have line grow be neck. on in for still base as Johanna? significant So approvals decisions. But to of head there. growth adjuvant timing we to cellular continue we that mutant renal our strong. we're see growth outside to additional U.S. are second in clearly, melanoma. We're in the We'll opportunity stable. and But additional opportunities and cancer, our regulatory be Opdivo And very be as for had will to as to will metastatic indications. will business, indications what term, those see Obviously, And

Johanna Mercier

Good.

ago into the important it's at and we important eligibility, have line. today actually what patients Conference, the planned. were on Jami, We've line progressed that business and strong So, predicted, understand one to regards XX% of second in maintain market, nine been on you spoke it's able is of very the pointed we've to as to I line out. understand as chemo that in second Opdivo of like a about XX%, absolutely And erosion to of our is the months of second patient part share dynamic are U.S., that base seen our to for slow we reasons six, kind had leadership as actually lung in lung, think Goldman of the

to temporal a there's effect So this.

you if of XXXX patients to in second market in does chemotherapy mean that will So are that accelerate this because will on and penetration XXXX, XX% of I-O that into eventually assuming first your progress XX%, erosion marketplace. there's in That second of about XX% I-O accelerates still that end actually year. line line feed we that penetration in XX%, about the assume that the first in are towards line line

other patients, second options. because as In addition positive some to retreatment also those no they have out patients you some line EGFR have plus well as chemo I-O

to about and about leaders All of XXXX, second And fact in end is today market drop together than is more XX% XX% we market in share from are a towards line. of eligibility, that which the fair represents which patient of of XX% the line. our get in light that second obviously, still we substantial

John E. Elicker

for please? we to one, questions. the Jami, Thanks, go Jake, can next the

Operator

Yes. Chris from The JPMorgan. will come question next with Schott

Christopher Schott

Thanks the much for Great. questions. very

on a sales your run specifically, Thanks spend this the question Or where this both Just think little bit so baseline. first here. the the U.S. least in peak through piece over color OpEx on sales Bristol as by ex-U.S.? just for for on of stand just I type guess, In to still percent and Opdivo flat investment when should and Is a broadly, you've lung was at over you ramp a I-O starting indication does XXXX more two spend? we more in can of the in And track do Are that we to second next of that? much. continue My R&D, I we about think two? or we PD-X, just think relative that point, XXXX at to quick past, on when business? plateau commented about point? see OpEx at or that Maybe time. trends And year

Charles A. Bancroft

back driven company, in been we our our company BD how Since enlargement no R&D. increasing pretty allocation it saw doing? so and really assumed is we you year of guidance flat guidance year, in in particularly industry our really as really oncology year managing portfolio. regarding So in and that regarding also then lifeblood OpEx, and improving Yeah, across our over Chris, resource opportunities and the we've the last saw and of year no you we additional have the feel this original and gave XXXX you are what MS&A how as consistent in OpEx,

In our with addition, assets. were where earlier at we

increased Nektar continue value areas know, the you expansion to and of and feel mid-stage between we where have we highest So initiation Halozyme and manage the earlier as we BMS. drive OpEx. those for our trials, will of it But our in

John E. Elicker

Johanna?

Johanna Mercier

Yes.

Across also such is ten is. our So, mix of then business and are what if business what's together X% because let the Yervoy melanoma that our in line Chris and of Chris, so mix, a here the melanoma, five, XX%, our and about bit our and increasing XX% for as and a international. at looking launches renal. in Opdivo and the to neck you're the so look business me And U.S. our franchise, regards with interesting adjuvant in in and lung that's of little about renal melanoma then little And is start in diminished will that's renal, is of kind bottom some about others you light mix parts. with head I-O bit cover in Chris. for of all at XX% lung

Christopher S. Boerner

the our things. little Chris, business U.S. reflects ex-U.S. lung me cancer. Yeah. outside of different of of Approximately in It's a That a allocation U.S. just than of is couple XX% the business bit the let take in

lung side. of strength we resulting vis-a-vis line had in and success First, the in our had access timing the and timing our access what competition, decisions being in cancer than the of U.S., from our also later business the on approval the that off as of the approval but we've second

and in that's our U.S. don't than yet adjuvant and XX% our in see melanoma cell the you And note, lower to our So XX% is piece, melanoma. reflective the in fact bit that cancer, a that approximately the of is our of as outside will have what in is of label we it's we business U.S. about of business lung business XX% XX% renal of

Giovanni Caforio

that summary are with good and that's tumor very balanced for rapidly, some the set that driven new a and within which the opportunities Yervoy and become base we by we think across types. growing it's important obviously. indications, from diversifying Opdivo I revenue franchises Chris, franchise, of effectively U.S. a very very Opdivo a have diversified And confirms international, So of now and Yervoy is

John E. Elicker

to Thanks, next question, the Jake? please, Chris. go we Can

Operator

Meacham hear We'll Geoff Barclays. from with course. Of

Olivia Brayer

This is can thinking how that is date on guys. hits lung, in Olivia NRx on regards around Just Hey, relative growth And where have questions. Brayer taking still And TRx Thanks early that see your declining continued should and are Geoff. curious warfarin's upcoming color for a With the launch Eliquis sort Eliquis provide continue first market. to share to couple. to year, and where relationship preparations a back PDUFA expansion, experience lie that? AACR you're of ASCO? trends? some line until expectations just about turning the us Thanks. expectations on then you for after I XX%? with Do next ongoing you linear to

Giovanni Caforio

you. Thank

pleased I'm I as let perspective. questions, where we and say me mentioned. very both So would you give Charlie Eliquis just with both I with my are

enabling significant incremental happening all us and is really the around rapidly. of brand opportunity. importantly, is more NOAC the We world. most of that growth But cannibalization segment coming is to that leading Eliquis to grow There are having as growth of the see the in warfarin in continuing very growth of from now that, terms most potential

Eliquis. on comment you don't why Johanna, So

Johanna Mercier

Giovanni. Thanks, Sure.

for your question. Olivia, thanks, So

on incredible we the after anywhere gap the year Eliquis, weeks. happen launch, one between, just XX% six year at as within to the coming closing growth mentioned, still between think XX%, growing growth warfarin NOAC. and And We're Giovanni now years story. should number that are as overtake I of

still TRx for about XX%. warfarin as about XX% of is TRx opportunity you NBRx the and NBRx, the the in U.S. think about So the you have

and think what's I warfarin, TRx look And what's is for important Cardiologists XX you actually at are to leading going of with NBRx indicator where about us for here see happen. cardiology points. the actually cardiologists. the

market warfarin still opportunity of course, more to and gets to being the fair number erode And big than really so there's Eliquis today its for one continue share share. a

the that's market opportunity. think market think well. about as we're also piece of a I one from opportunities puzzle expansion thinking I

warfarin about, there's think of are As on million actually about is that are X you there's not another are diagnosed that patients TRx that treated still actually and X uncontrolled. million just those then patients There about and XX% undiagnosed.

think important market I the future so for opportunities well. And as

that will referred are continue believe and to. we I you to trend this brand, on that grow currently we linear that So do

Giovanni Caforio

I think what's also very what what's with there that from Johanna good internationally. is heard happening consistent you is

in has key look are be the You look at be The the now setting board. line for position brand, there. with Eliquis leading this first will at opportunity we France, across a improved access in Germany, have the in you to now, the we because markets environment France the used actually significantly and able evolution of reimbursement situation

to probably of been for say we've respect future would on executed successful. consistently of the With readiness lung, execution your just And one launches the question we've launches the with our demonstrated across every there is organization. that our very launch board. the of very has I commercial think strong positive So one I every

And you've Yervoy about capabilities the a confident Yervoy did our actually I'm indication. XX% is an that is commercial heard uptake very not happy that about we in the penetration really strong in renal of important prescribers I'm plus there good are the Opdivo What's are seeing that because experience have the organization. melanoma. prescribers in in U.S. of So renal that low dose of with

adoption base significantly and combination been Opdivo the of Yervoy has of and will the that the quite So good. experience broaden

John E. Elicker

Jake, can Olivia. we Thanks, go to the please? question, next

Operator

Yes.

Bank America. from of Gerberry We Jason will now with hear

Jason M. Gerberry

my Thanks taking morning. for Hey. questions. Good

line some lung I using seems first plan Just front two kind on oncologists saying second the the it in guys back only you wanted that in community XX% the about to confirmed line, survey from what come actually We've patients suggested, setting of still work now. like to their to U.S., line within in were years that done chemotherapy dynamics. of XX%

oncologists that's community to you sense better get I'm going alter two Do your line that? you is Thanks. to general in ultimately sense, that Do sticky just and think to dynamics second so just Just after the is being that that's wanting to reverse slow first get And feel that's years? to trying lung. how likely change? a why like how line,

Thomas J. Lynch, Jr., M.D.

a a as a give practiced Jason, as So, let that oncology long who oncologist, for time. me someone stab

I if of when patients line oncologists. do variable, won't still number away. will XX% have depending of think it above reasons. any different who to you therapies, rarely XX% of new gets therapy, uptake I-O new upon And right be that to look get there a is groups first penetration for the think you at I

still not So like with And keep reserve even who lot treatment second key in been I'm with therapy with seen held And the other a the them thing Taxol/Taxotere that altogether. chemotherapy. we've to a first physicians line go of as great there and on actually continue to is are surprised back that have over using years where EGFR something that's well. doctors line inhibitors people

So something that's for actually surprised think And by by seeing. that, that dynamics it's in behavior physicians some I I'm you're of not the setting. this accounts of seeing the

Johanna Mercier

of looking the other what you maybe XX%. at of just when And anywhere and think seeing a has about rate tumors I-O to between that I-O we're penetration XX% that, penetrated, you're add all to

lung line penetration XX% So on even of the marketplace. there's than a proxy, no as years second you take if a couple more after

TRx still earlier, the so what that if the the warfarin little products I-O marketplace. a marketplace go oncology, you referring much at look at just bit And you you and outside are to just so profiles stronger, on have are And that's their that look of XX% were we of you warfarin. available within just

Giovanni Caforio

Tom. Johanna. Thanks, Thanks,

John E. Elicker

for Jason, Thanks, question. the

Jason M. Gerberry

you. Thank

John E. Elicker

one, we can the next please? go to Jake,

Operator

with Baum from hear now please. Citi. will Go Andrew ahead, We

Andrew S. Baum

Thank couple of questions, you. A please.

look you when and dataset of could us you a the the but before have should going tell time the that XXX my the year. Firstly, it's to presentation had I at that last be end was to data? moved. we seems But competitive sense this of expect understand initial issues,

is question The to second Giovanni.

is to book appreciate have sense the information, uncertainty whether share it sent proposal, any President's, us you. you plans, business? in commercial understanding I or the either federal Given potential plans the to to the the would much as of been negating think federal any rebates, amending that's impact? additional within could whether President Thank of you the PBMs extent of on extend change timing proposal here. with to Any relation your just And as of you

Giovanni Caforio

you, you Tom, on don't Thank start why XXX. Andrew.

Thomas J. Lynch, Jr., M.D.

thank for you the XXX. question on Andrew,

just let's So and why we think is XXX do about what do XXX.

support that XXX practice-informing development enabled non-small study at a get to a on TMB It study, that biomarker. then some lead-in We a to study help cancer. as of was a us an study Opdivo/Yervoy to So cell were in important with was translational we to looked able initially patients the XXX. data lung amended that safety use that add

it looking looks trial study that which with population. this to large with lead-in would XLA, the two at which that of XLA. then chemotherapy And setting. will have Opdivo/Yervoy one safety suggested XXX our study seen profile yet acceptable the next which The cycles in be along opinion far, at readouts we was changed lung the have have done to our we you two and hope this. so that XLA non-small XLA in the done be able cancer so was on of and for we look basis untoward data became when in safety advantage have to were patient accrued in approximately data compatible patients not And as safety cycles about of amend year at we randomized And of any study given something potential is Opdivo/Yervoy, the cell front with by chemotherapy study end the the line know,

XXX study venue to indications. of yet the a Andrew, we decided that of data, in not helpful terms the other of upon So these in very have development been appropriate for presentation us we that. has think presenting

We at to a future will mature continue look and watch forward data presenting it meeting. medical the to we

Giovanni Caforio

make Thanks, very here. question three points. like maybe Tom. Andrew, I'd important so to

is that So we I'd change. the first the need one to for like make that agree with

prior which a at time in to of cost patients issue. growing continue is in you market price If dynamics many is at increased for rebates and an out-of-pocket look cases years. for increase, today are not the patients in affordability There versus medicines net

patients at to chain so incentives in fact important there. we of and have issue. clearly that look a change the need there It's interest with the to look it's important that the misaligned So agree to that supply become is at

make would like to administration. I that are the point with second is we that working The

with We these work to are on topics. continue to really looking the administration

what early before. think made speculate very I the to it's There at is a comments need and changes will definitely be. to rebates I look

in the space, the at dynamics space I think Looking this a It into speculation. in over some point translated very past, at have Medicare in commercial in early. but change would changes time the be again, it's cases

to evolves and want a we priorities. three what at is looks see think system I that

market of we are about the together incentives patient all The and want what want the potential are in really be administration be are these by affordability one any the is forces. We needed we to there and a driver market is and work cooperate first change, changes support realigned. system. And to definitely innovation be with where driven that and think elements the to to rewarded

for year, to as make innovation of The all first need, the would are volume. of our growth this innovative of experiencing that U.S. very I third across the decision. prices brands, at the flat medical significant by driven say the unmet are positioned. medicines half really in net like prioritized that volume is I'd very our in look six areas you when first the because a and in with it's high have point months made that year growth And company differentiated we growth well an net were was we we

the this to increases second going We of year. price in take part are not

that when sure I'm believe changes you very important our positioned we're our time. BMS believe for working patients, pretty medicines at think all and of well that But I performance. transition that we in and parties market. important will in the of be right because reflected this through interest the be potential there time an working will some transition the is to the need I periods really are see through I

John E. Elicker

Jake, Andrew, next we can go thanks for one, to the the please? question.

Operator

with Alex BMO now from hear We'll Markets. Arfaei Capital

Alex Arfaei

and you some encouraging A about from competitive Great. on morning. We've data Tom, of I good may. plus think Thank questions do RCC? couple TKIs. the seen first PD-X I-O, horizon in you if how much line very

And even of Keytruda I XX% monotherapy sets with think ASCO. response at there's that data interesting data rates had pivotal some next out year.

if that you your There some wondering settled impressive still now wondering think And that you confusion was that I'm the after provide on NKTR-XXX then the if be latest ASCO. has think So early I comments launch in data persists. you. will around RCC data, dust the could sustainable? Thank

Thomas J. Lynch, Jr., M.D.

Alex. Thank you,

study the beat reacted So important happier cell. was that the starting off, let's physicians, a a It's extremely with an the academic physicians that there I cell demonstrated talk renal have renal way for time XXX. this be trial about could therapy active We think that Sutent. is TKI to really very carcinoma. in not the first that community could

with low-dose So it's so launch Yervoy and setting delighted and we're I'm well this the of Opdivo/Yervoy. delighted accepted to that. and doctors It's in patients being by

I practice therapy when ago, I of I the this XX cell single Velban. to is However, treated renal think of think agent, the first out, I think, when point not in cell back my end using carcinoma. were carcinoma we own and evolution When years Alex, as you of renal

Obviously, remarkably come impressed early is we've of the data. with time far with this how the this. PD-Xs and I am in data some So approach we this in the TKIs.

and plus at to that that our XER, trial study We TKI. we're a look have cabo PD-X a looking pursuing, a will Opdivo with which forward doing be we

will may I with depending patients market I cell And But will of plus I of characteristics the forward. think think to upon a a moving play different different a the characteristics very patients will lot be be think turn where a like to you're to segment may important treated continue important. molecularly be in role continue a population forward. out seeing and we Opdivo/Yervoy approaches there TKI I in think see patient as PD-X carcinoma the where the you lung move cancer, renal

to forward again, carcinoma cell as we So look renal move more forward. in data

your another renal get where we we question, stand carcinoma Now, some second might is in which is and NKTR-XXX. cell with data place with NKTR-XXX, do

about enthusiastic that ILX. the the So, only the saying in of There that let class, extremely the me proven been mechanisms I class, am that's just are because off have I-O. in improve PD-X shown outcome one and CTLA-X to start I-O that's NKTR-XXX drugs that it's by fact three that's really of and

Treg within we process, to side possibly which at the pegylation the ameliorate the stimulation deliver the tumor, compound, the population potentially periphery ability same the NKTR crucial have to the T-cell is in the ability effects. With still the has which increasing time

there's the pursue this pursue development So of mechanistically, and think to reasons I a lot agent agent. this of

soon trial very seen some Phase design we have melanoma in what encouraging we the We've soon. seen on hope that far? X So clinicaltrials.gov. And that's trial will to led accruing so which that of a will data start you see

in closely You'll see on the them study evaluation cancer very Phase the design X we we in Nektar PIVOT-XX, the with cell and data by a which run our in forward. being but also study by are move of bladder the year renal of the in of working of end a based a design initial that's study as

to has So evolution forward terrific I tumor of NKTR types. other promise. the think that seeing I look

to an this up agreement we at with types As have setting. look to you Nektar in tumor different know, nine

So put day questions a NKTR-XXX forward and to to eventually just I where carcinoma. your in this renal how that this But Opdivo it evolves be look one may seeing makes seeing plus together, two role difference. cell a plays well

John E. Elicker

Alex Thanks, go the questions. Jake, please? one, we to for next can the

Operator

Risinger will from we Morgan now with Yes, hear Dave Stanley.

David R. Risinger

questions, very please. two have Thanks I much.

to on continue mentioning timing for First, expect an the you XXXX. be update readout to that you provided late XLA,

overall whether should XXX second then gross upon overall survival. going on one additional readouts forward? mix you Thanks improvement future depends question comments evolution the survival TMB comment be could in margin please positive much. PDL-X difficult if any wondering but have so and gross forecasting Obviously ahead it on of And is Just my assess years. margin the to it's any you for

Thomas J. Lynch, Jr., M.D.

in the margin decay margin the than So, question. Dave, part rather gross growth your to company. I answer for the contribute thank you it probably gross the I'll of of tend of to first in company since the

first, to question your XLA. So on

this XLA, about is on something approach. a very enthusiastic we're So again, as

combining what most the you effective two with cycles perhaps potentially of chemotherapy we As setting. along believe so in to this know, be regimen it's Opdivo/Yervoy,

think event-driven certainly could the and study. XXX events when happen that readout's slightly Again late we to the decided have about extremely to was XXX of at as patients. slower, readout gone accruing impact the and It this know, if about so would in patients this occur that so Dave, point. XXXX. well, again, We the are occurrences, increase these or to accrual But you quicker has accrual going be from

are there going of data. some where XXX, XXX's Regarding to produce a places couple

XA part be overall positive So – the part X part trial from from would in survival in PD-LX XXX of – of of trial. the this group trial first this XA this

safety We any data, at committee. data expect from driven. data that. event our we seen That's survival again, monitoring by haven't It's looked that been

other the later we've versus X question sooner. It's that's that. our saying, think It As But which it your could again we bit XXX, overall chemotherapy be regimen would chemo. be than probably be of is been Opdivo the chemotherapy. And early XXXX. of a little survival then again, could finally, part from part

to again, be could the a Dave, with an is event-driven be early little bit We expect XXXX, later. little process, this sooner, a could be that bit caveat that

Charles A. Bancroft

Hey, Dave. This is Charlie.

big a question, play part margin our Regarding always gross margin, your evolution. you're Mix will right. gross of

quarter from I year happen guidance by the first FX. to We half our don't same margin quarter to of expect mentioned sequential for XX% gross for gross that was roughly back remain in and my this comments, impact As will margin. benefited within of second the

margin. we're margin I Moving in we're now that forward, the of predicting last sort of quarter, gross going trough forward, mentioned the now gross as our at

last margin that the seen that had So primarily we've we've we're now had, Eliquis, feel but on we strong growth years, of mix, over degradation, several out of because you've gross as margin. bottoming the

John E. Elicker

question go Can questions. Jake? please, the Dave, Thanks, we the next to for

Operator

Steve hear from now You'll Cowen. with Scala

Steve Scala

operating in to would guidance instance, what which and see to Thank given expenses? through look be answer. expenses the operating growth expenses we versus guidance new if question why first Bristol you. Opdivo TMB the priority one? review on did in low-single-digit didn't operating I'd like needs Chris's the the follow think and on prior And very a It for offers the CheckMate-XXX of should just new spend, on seems flat XXXX from catch apologies didn't plus for FDA the up a I'm not So I you. But XXXX? filing the for approach, get that do lung And using way. differentiated it Thank useful wondering second, that TMB ask a Yervoy based on FDA? did line you approach, why

Giovanni Caforio

Steve, changing so speaking, But flat with guidance not not I'll saw broadly really We're ask respect that said guidance. always Charlie are we to roughly the providing new comment. period. to we in OpEx. We've

as We we also would that fact needed, we that. executing discussed fund opportunities the and incremental feel we are against

Charles A. Bancroft

Yeah.

we've BD guidance, we are when opportunities, earlier Nektar our to I decrease excluded R&D. and I gave we going of broadly Halozyme the to would about size were going it leverage different invest will But it of we Steve, forward. number look we've had and ones as business may notable that though and in think forward. think most at have my of in And where most we we comments a heard MS&A, you continuing BD, continued

we our higher growing So our at growing we a than sales will be rate will OpEx. be

Giovanni Caforio

working potential about the world. and and thinking segmenting the regulatory value with as ultimately, is the fact we agree Difficult decision you authorities to the lung Tom lung a cancer obviously is are the with in it to with But speculate market dynamic around market. with cancer on important very authorities. really submissions interactions different on the regulatory be TMB Steve, the We that mentioned, do on market. stays approaches of FDA,

John E. Elicker

the one, Steve, to questions. Jake, next the we can go please? thanks for

Operator

now You'll Umer Raffat hear with Evercore. from

Umer Raffat

Hi. may. my I if taking on had questions. two Thanks so I much for CheckMate-XXX

wonder the open from staff low? the First, Part did I PD-LX potentially change. in you be the contemplate idea filing I-O plan regulators the could CheckMate-XXXs ask despite And chemo I Xb to if because of

on thoughts your get to wanted that first. Just

Like question on TMB we've which biomarkers is filed the down at I-O stringent been they've and by Secondly, is data you in first TMB extremely XX for you trying be drilled looked XXX indication TMB Because a extent onerous rigorous I-O, my more TMB now XX? do above what Thank one by to subgroups, CHMP seen risk versus and XXX narrow to has to CHMP that cutoffs? get as high, to and any with to lung? the the have I'm line you. limiting XX more foresee

Giovanni Caforio

Tom.

Thomas J. Lynch, Jr., M.D.

let's So take these. of both

your So, on for Umer, thanks questions XXX.

not this approaches process, out you to important what patient is that be will our point we in, to decisions to in in one again, comment good, the very XXX that of I some PD-LX we And Part is in cancer of except going will if has of to Xb ASCO on groups we're not think gave And as learned continue discussions us the happy said, say Opdivo were we some I've segment part benefit have are produced We important the in beginning that population. that reach. announce of they we about cancer. the and treatment to with Part really very things. treatment negative similar to that What of chemo the are patients, lung than of XXX findings major is, better, and other data share and a a which So there said, first opportunity important at the learned Xb, for regulators, patients. present as lung the Umer, from think evolution we've things the that that multiple that going

TMB PD-LX That you're going another I finding high that marketplace presentation. ASCO appear being part you you if benefit And Opdivo/Yervoy be a with that then the setting. doesn't heck you that in negative, important to I-O treated heck think negative, in of that negative is you're that actually TMB learned is the setting. see from PD-LX also a was in a it with better may do We finally, lot evolve of learn lot, a of a to if

data look seeing XXX Part your that forward enthusiasm for So the to I from Xb share evolves. and we how

XXX a as forward was generate the TMB the patients that setting. of the patients being patients And authorities that suggested as study from XX in regulatory we as a use sources. the We treated again, look with appropriate your discussions with around of therapy to well TMB, use I-O, cut-offs study number from curves be you that. for cutoff Regarding I-O to to second that XXX know, question able for on we

nature As you how at know, those evolving don't this we the are of time. discuss discussions

John E. Elicker

one questions. Thanks, we to the the Can Umer, Jake? please, for next go

Operator

with Yes, Securities Credit - LLC now Great. hear from for K. you'll questions. Divan Suisse Vamil (USA) Divan Suisse. Thanks Credit Vamil much the so taking

China. recently two And I'm from So topics for from we been about just including especially just there, slightly different as Opdivo pricing more see Chinese One, that you PD-Xs potential enter wondering covered. got some how market think what's companies. you in approval

on curious And how that Eliquis you there So large more in the hold market. up second think the side. pricing one then might

Eliquis, going be the just how well to recently Phase to now You Factor with given there collaboration partner Factor And with announced XI. a seems on decision a on to move X J&J Thanks. and the the for different Pfizer collaboration XI inhibitor. I'm curious, shift the thinking the gears

Giovanni Caforio

you do discuss Chris, want China? to

Christopher S. Boerner

happy be to. I'd Sure,

in a as comment at cancer lung diagnosed public setting. survival real and very late So opportunity. very overall cancer improve need with in this lung not drugs this in are you of line the is an going diagnosed China quarter. Opdivo on of approval that thanks may the We're the like and price cancer, for a that disease Unfortunately, with are China the question. Lung know, to patients in so in China Opdivo obviously earlier happy second who significant We're there's for this point. issue obviously health is many exciting in

of can't specifics. to authorities. are We the pricing comment materials in process on submitting the health We

here Opdivo think price complexities the is of the need true the this market. It's a one in this obviously we other as in about Price reflect of of value potentially to unmet However, in would large China. high opportunity. recognize markets, and market is

highly of care health think in availability I where some recognize care of an is is fragmented very basic This a and realities is large However, somewhat issue. it still system. the China China to of market important the to

time, cash into out, While will from as before competitors. the well pay to Opdivo And space, improved ultimately, has a over in be national access continues as secure, as be evolving environment from both point there's an you local to reimbursement. launch competition and we provincial going this this market landscape. multinationals

to very product Opdivo notwithstanding, that forward available about authorities this health excited opportunity this space working the look in Chinese for and we're much to of All year. potential the later make with

Giovanni Caforio

we Chris. It's first-in-class believe and and you, the on Johnson. Factor quite potential best-in-class into a It's going just days. be XIa Thank we're Phase agreement, a excited with about obviously the that Vamil, X, to partnership early program. has

If you have we think experience able to that in together of just companies were cardiovascular. great very agreement discussed was two a two We're companies. about And the the this it, with partnership of happy companies any an the because experience for thrombosis. combined obviously, program, sign in with today we Johnson many

think this. period longer presence over in for forward I program an a This time. our we to it's important expand of disease look we So is And have to a advancing great opportunity cardiovascular us.

John E. Elicker

have Jake, questions, two Thanks. we more I please. think time for

Operator

to SunTrust. move John we'll with Boris Now

John T. Boris

Thanks questions. for taking the

might you the relative type. over Opdivo/Yervoy, within and they're probability be can time? clearly, then But XIa, that have the give nine types? tumor the influencing And you class? U.S. color you about commentary academic just just plan indications. tumor the how the the the to the you of first, on or time into think you on indications evolved community on side gave they program, care and how academic On current using market differentiating centers? of First particular, couple NKTR-XXX you in of product how through by the on for terms some of in the Appreciate centers can Tom, Thanks. question, success, Factor When about standard U.S. the changed thinking centers Tom the And over are last go you discuss that commercial in how breakdown

Thomas J. Lynch, Jr., M.D.

So, thank you. John,

think about NKTR, I I what with said Just earlier emphasize NKTR. we'd just

as renal where and in we're proceed I the follow in data areas to think And emerges we've decided bladder. well. melanoma, these it going to other

a which know where the types other data mind we until setting. emerges to So that to I in be think difficult that. are likely very going tumor the of we keep see benefit most open to to But it's

the our Factor develop compound. Second question we prevention. work XIa will able be regarding forward secondary at to with XIa, stroke Factor area And in Janssen look our to be initial of to this with working partners

the There secondary anti-coagulation Factor a need. will are inhibitors. field profile medical the to many have that. unmet actually quite we may know, where at But emerges see be X will time. prevention how yet. this We there's data that. broad. superior is stroke you place continue know reasons are to As to the of of don't with to And And Factor looking for areas XIa first have believe look our that we There

Giovanni Caforio

on Johanna, academic centers.

Johanna Mercier

Yeah.

the had. plus your as to launch John, melanoma well in recent that Yervoy, actually important So O it's question, I renal just look first is to we've metastatic combination as think line at in in our with

seeing supports how is mix a real melanoma, that pleasantly in academic see surprised. number think We've about were that for and thing you're that line line I we're the the And bit already what's We that uptake one And more between both strong in think the seen than renal. heard you've is treatment first renal. a same we've academia community. definitely from been to been assuming I interesting metastatic first a standpoint little community.

the low and So a the And of I mentioned XX% are lot dose it. think Yervoy. first Opdivo time, of users trying are new about by as Giovanni of these folks combination for earlier,

as the an think and indication to I of XX% interesting about well future the you when target targets, actually we community. is piece think experience think Opdivo/low lung about lung. of I treaters, the just as across that as the potential making you think treaters, because in that's And academia Yervoy, that's dose overlap renal build really interesting sure that

John E. Elicker

our Johanna. Thanks, Great. to we Jake, go question, last please? can

Operator

from Yes. will And Blair. our William final question come with Phipps Matt

Matthew Phipps

in kind think drug combinations really that? is then those CTLA-X earlier compounds And some straightforward, where, the almost for advance trials. new have a have can confidence clinical your Yervoy you from all you of once stages, strategy designation with a lirilumab comment combination the cancer. Or fairly there Opdivo? signal, enough to Yervoy those in bit we've slightly the with you we of room gastric with you for indications, there? return of compounds Great. of you on squeezing antibody a but growth of to for of at in. multiple from Obviously, forward? Two that combination questions Tom. nivolumab me supplanting little for move orphan seen kind Thanks Can do also, of fixed-dose fixed-dose an earlier do interesting different two large for LAG-X are large results When see And a

Thomas J. Lynch, Jr., M.D.

you. Matt, thank So,

So questions. couple a

I'm as enthusiastic you So picked target. from up have CTLA-X may prior very calls, a about as

expand I in target our the it's program. have of compound really think and anti-CTLA-X of both Probody I we index and that a the cancer, we upon therapeutic opportunity CTLA-X very think have important to CTLA-X CytomX the with non-fucosylated the

this your in share in Phase point. Both early these are them. drugs of trials trials. still X They're at enthusiasm phase for I So

Phase is So I promise CTLA-X this the coming what what don't can the drugs at imagine what cancer. that be in do look until would role X. we of But expanding you of we potentially can sort know as out will of of profile the see really these

potentially addresses some exhaustion, to It T-cell we melanoma We But LAG-X. presented Opdivo offers about of combination LAG-X in the think and that And have therapeutic might getting in that melanoma. Opdivo lirilumab with year very fixed-dose and seeing patients concept is very is interesting that last forward LAG-X to the interesting with a have Phase think question running. LAG-X X compound could cancer emerge. We and we previously-treated data ability second where The look that in to setting, data place be we plus trial a approach role. a look a of compound. and LAG-X a gastric our forward also up

Giovanni Caforio

is quarter that of business everyone. Thank and very second a you, into this the There half. good Matt, the in thanks the going execution half Again, year. was first momentum to pointed in strong the very,

forward catalysts for the feeling have is number am good where company with, important that and I a of everyone call. today. looking about We Thanks in we're the pretty participating

Operator

you thank And gentlemen, does participation, conclude for and disconnect. today. and now your that, you with ladies your do We this conference may for

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