Bristol-Myers Squibb (BMY) 26 Apr 182018 Q1 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.
Murdo Gordon	Bristol-Myers Squibb Co.
Thomas J. Lynch, Jr., M.D.	Bristol-Myers Squibb Co.
Jason M. Gerberry	Bank of America Merrill Lynch
Christopher Schott	JPMorgan Securities LLC
Jami Rubin	Goldman Sachs & Co. LLC
Umer Raffat	Evercore ISI
Andrew S. Baum	Citigroup Global Markets Ltd.
John T. Boris	SunTrust Robinson Humphrey, Inc.
Geoffrey Meacham	Barclays Capital, Inc.
Timothy Minton Anderson	Sanford C. Bernstein & Co. LLC
Matthew Phipps	William Blair & Co. LLC
Gregg Gilbert	Deutsche Bank Securities, Inc.
Vamil K. Divan	Credit Suisse Securities (NYSE:USA) LLC
David R. Risinger	Morgan Stanley & Co. LLC
Steve Scala	Cowen & Co. LLC

Call transcript

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Operator

Good day, and welcome to the Bristol-Myers Squibb 2018 first quarter results conference call. Today's conference 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

good and Lauren, you, morning, everybody. Thank joining for the call results. QX our discuss to Thanks morning Caforio, Commercial are Charlie this Officer. me With Giovanni Financial Lynch, Chief Murdo Tom Bancroft, Chief Officer; Gordon, and Chief Officer; our Scientific Chief Officer; Executive have Charlie and remarks be will Murdo obviously Q&A. for the Giovanni and will prepared and Tom here

Before Safe Harbor it to let Giovanni, over turn language. I me the read

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

Giovanni Caforio

competitive diversified of growth a to strengthen Thank proud in continued across performance the delivered pipeline. opportunities morning, first Today everyone. commercial in and company. execution quarter, you, the progress good and John, and made we reported I'm our against oncology, superior strong We environment, a significant

was am identify treatments. of increasingly a And sparing the dynamics to advancing in are played We the science in I-O-based important defined to a opportunity play and chemo an the for who patients from become has and that also scientific our CheckMate-XXX. by teams study believe we can role At I personalized in meeting TMB I'm see patients. durable a medicine science I'm I our which helping will patients the to new highlighted same proud biomarker. role important. with out commercial I seen proud encouraged later. sure advancing the let First, AACR, news me deliver in deep which I-O, of a this good discuss which in of of rapidly and will important very we coming quarter. benefit was option discuss the and acknowledge important an AACR, set results time, competitive responses that

company continue before, Real the year. As and is Eliquis and I've Opdivo good shares is overtake to characterizing in lung, performance. and said leading and data well delivered world head strong to at on key saw established deliver benefits Eliquis and is Opdivo this of neck. with study the ARISTOPHANES, for as warfarin further franchises indications are NOAC Eliquis. melanoma, track now March. the results world ACC real approved across presented we large maintaining performance, strong in a And RCC, leading

trajectory Additionally, see for indication adjuvant this forward. and are the growth continued with going launch pleased we in melanoma

excited one been we success strong U.S. the RCC a recent is growth this significant RCC ready line. of And mentioned launch, opportunities the Anticipating year, I second As the our teams approval, for first-line support and in building with Opdivo this of Opdivo. are in Yervoy earlier have in to are billion-dollar-plus plus approval the preparing on

and academic approval improve secured dosing patients and four-week we interest in regimen community we've convenience EU both Opdivo. the settings And FDA for oncologists. seen significant for In using addition, to

the forms adults combination These indications with with to second-line Yervoy potentially important Priority cell for are cancer. We for and also received therapy metastatic two opportunities a treatment colorectal Opdivo, as lung of cancer certain broaden a small Reviews third-line for for as Opdivo. in

in the answer third There science I rationalizing In during overall both I-O adds data developments promising our best questions in a were we We many know And prioritize we oncology, look our forward Nektar pathway IDO benefit the strategic oncology, in the Q&A. IDO. and agent. well scientific to We quarter. with recent were this source ASCO externally. on new validated updates quarter. a Incyte across at have with to from business the our announcement own as resources ensuring collaboration program, on IDO specific in program, internally patients. We about the questions active that our development we portfolio. And continue demonstrated for you clinical can Based data has the are as

with diversification also our pipeline. We our in advanced good strategy quarter, in progress the

First, registrational present data and studies, year. in planning we our to inhibitor this TYKX later are is psoriasis advancing towards

our from many strategy and lung, liver, head disease look you. with Phase next Opdivo quarter, the XX and We our support seeing and thrombotic also excited III develop broadened and progress are collaboration growth. forward area strong the in excellent important science with closing, the for advancing announced important to In forward to Janssen am medicines our growth of our I Thank commercializing to with based we treatments pipeline, thrombosis. from disease the also look positions a cancers to well where and forward development the Janssen across where we in XX our new commercial XIa. Factor working data growing the significant confident Eliquis opportunities delivered understanding innovative company the We we in business, gastric, studies areas long-term an us of that future. in brought Opdivo, important have sustainable and had I'm performance, we in months. to neck readouts in with on with

over Charlie. it turn I'll to Now

Charles A. Bancroft

everyone. morning, Good

strong performance As Giovanni key financial delivered results by we very the brands. quarter, described, just robust our during driven across

by also due In Our franchise. Eliquis. benefit we a I-O Starting prioritized brands quarter, up exchange. with our strong performance to X% Opdivo on driven for XX%, the were had and revenues foreign

to at continues competitive execute organization a high commercial intensely in our mentioned, Giovanni level As markets.

strong the U.S. billion, by benefited approximately $X.X driven XXX of to million also by in quarter, vial the the Opdivo demand. stocking of the During $XX launch mg from Sales due sales with growth were

across to our continue our U.S. non-lung key with remaining we second-line come share set, lung drive we've also indications. sales share of XX% indication now While approximately broadened from roughly stable, indication, leading

and all new Outside markets. markets for as point, rapid We in and adjuvant Yervoy uptake At indications, strong execution we've Germany, melanoma in the U.S., and are such reached dose France, such Opdivo cell. reimbursement low seeing enthusiasm key strong major in almost this of remains first-line for renal launch indications as coverage Italy, Japan. in the

our Exiting melanoma Opdivo and to combination approval melanoma leadership quarter, with adjuvant first-line And first-line as launch pressure are in to in set expand QX the positioned metastatic of We the the With we stabilize. adjuvant RCC the respect outlook to trends RCC. begun low potentials first-line indication for we well continued with on the back call, the rapid half Yervoy, our have and of melanoma. remains internationally seen discussed uptake positive, year from have new for with of the Yervoy. earnings dose

over year driven of supported Sequential in script real-world exceptional expanded the markets in Sales, Now turning U.S. and sales delivered steady competition with on the prescriptions NOAC by however, the sales warfarin in share lower of later and as expect position Sprycel quarter were reduction leadership in growing among generic around imatinib. in current Eliquis U.S. lower its to by Internationally, and its best-in-class clinical continues market. prices. has important coverage average the TRx, Eliquis, grew total become which AFib we data from to were it product to milestone. trends, the further gap XX% products, the as in With be net one of profile negatively this world. to XX% impacted a the for increase a other trends to positive cardiologists of script it number it last growth Based foundational the Eliquis surpass by compared from inventory when an selling sustained Medicare XX%, for stroke remain lower positions QX across the leadership. despite respect effects during number and NOAC scripts performance, Eliquis total year.

down Now result a last while year, mix extent, I'd efficiencies of a With a in the lesser to from same In to highlight high exchange. behind gross to compared quarter, MS&A like non-GAAP XXX prioritizing to points margin foreign items as we to expenses, resources primarily time regard approximately our P&L. drive and opportunities. was our few the basis continue value

expected for XX% range year. to are our in rate, tax of the other quarter non-Amylin royalties, affecting that income. our income to items the a are we've step-up rate, and discussed, the other with expense recorded benefits As net recognition in of now year restructuring we pension AZ of few regard increase for rate the a and the expected this and royalty In XX% to there

seeing And of First, as are we of Rico improved code, expected lower excise a well the the income utilization U.S. impact foreign than jurisdictional new tax favorable Puerto have under taxes as credit. mix. tax earnings on we

rate Looking possible the could is depending that evolves, slight and we tax on XXXX, remainder XXXX at mix and code it on into improvement. of how the see details additional

to conditions. with to agent tailwind our for with Business our transactions dividend. immunotherapies. to has commitment to $X.XX. multiple thrombotic a priority, take excited Nektar the rate, to our companion commercial non-I-O the to innovative on strong develop EPS as on our the Outside includes as are as Factor We and provide on which with $X.XX range We of to some I'll guidance we Based and portfolio continue well advance our I-O XIa does our comments clinical and executed advance remains capital a of commercialize that innovative bring Illumina balanced guidance. to on program our collaboration with adjusting to the oncology strategic are now sales I-O, This our FX, outlook performance, diagnostics potential allocation. to agents. tax from J&J, have patients approach global development top non-GAAP this collaboration revised we and potential a

exchange we deliver across areas always, rates. continue to strong As foreign quarter, current a our execution in and prioritize To commercial portfolio, excellent range very by our this close, we marked assumes had that value. resources

we well and a going opportunities continue to positioned, growth of see is business to drive forward. number Our

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

John E. Elicker

think to the Thanks, Charlie and ready Giovanni. to Lauren, I we're Q&A. go

Operator

first America. of with Bank our question take Gerberry We'll Jason you. from Thank

Jason M. Gerberry

Hey, good for question, and for my thanks morning me. just taking two

the of what market obviously Eliquis, And every just percentage about conversion quarter. see in points First, on from share is calendar quarter. strong warfarin we X a

that what think at about data question, going So of not on least trend And file understanding just that is Do descriptive there linear? we think then My could the there? I'm guys you be you of terms it's any second data my gating head curious Opdivo-plus-chemo Do in relatively would to expect analysis, ASCO, into enable of as that that But kind that you should could are clarity any think combo. downward? how just presenting be that approval be as slow you'll chemo about for it trend. we helpful. you your combination to factors Thanks.

Murdo Gordon

Right.

So, Jason, a see relationship bit I'll an your it's here. primarily contracts we're question growth. related prescription position. shares, TRx first do to Murdo I Eliquis. a XX.X%. new But of on But if see NOAC did We the on share. access a access quarter, look in and around Eliquis U.S. NBRx higher, fairly our We running XX% strengthening running share linear of uptick first is at at a our at answer our

linear a fashion. that total that indicator able you our we'll to continue prescription relatively grow So to be in share gives a leading

Giovanni Caforio

regarding as as the total progression the the opportunity, to there. on than of total higher to when question I continue comments see terms to are in which And there look market NOAC at you would growth to NOACs in significantly to total, TRx's grow. the in And opportunity the well, we for specifically more for points penetration the And NOACs of continue comment the echo for market your NBRx's well. of warfarin, Murdo's

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

And, Jason, ASCO. about your thanks for question

meaningful coming which first, our As think in combo to of to of be I-O/I-O you portion sparing durable statistically begin felt CheckMate-XXX, going the trial, to And be ASCO a the how well we we first regimen, And step? chance think chemo see clinically significant know, important see deep combination population. our in off that is were say spectrum chance present things, at that But PD-LX looks data negative a to patients. setting, TMB is Ib like to established very was chemo that very AACR, next the time us will to will presented seeing get data across at therapy something look sense in busy which negatives. only but Opdivo on the in not going couple patient some I this responses of forward we with versus be Opdivo/Yervoy and the the extremely cancer. oncology. an might the a potential lung for What it as meeting. we in PDL-X and work from that happy just although you're ASCO we are to data the look in the mostly a PD-LX of really what first and of will it to this where We at chemotherapy

have TMB think our some are Nektar to merkel of we Look those you'll they a interesting I-O/I-O cell Again, can confirm and regimen. be also an ASCO very more to very report from in data paper There Plus benefits in I outcomes eager data present an if breast some many very population. from in update see that neo-adjuvant see Nektar, the at cancer. believe patient that. we collaboration. show forward of interesting from the what will data and

So interesting and very a we ASCO expect vigorous meeting.

Murdo Gordon

being well The than research I add a making. only see looked oncologists. exciting AACR the market has physicians real aware. of number treatment majority TMB about biomarker, decision oncologists patients recent understanding with a is increase thing U.S. of academic from surveyed TMB for of the is saw more the biomarker, in a in as nice then out status very vast the community having TMB also we doubled what's in of interested for of of And utility as in half physicians in interest to would awareness at us the as they And

including So ASCO as to and interest coming that going plus PD-X Tom TMB. out in data of think to in said, I having more descriptive to it's comparison at patients chemo, drive other subpopulations continue

John E. Elicker

we one? the Jason, thanks go next Lauren, can question. the to for

Operator

question comes JPMorgan. Chris from Our next Schott with

Christopher Schott

forward about just we their around the And of hands of you a about adjuvant there indications was results? those dynamics just light of dynamics Street little what impact when I how Can thinking KEYNOTE-XXX then that to could bit lot do in the much. a we bigger you. terms each quick elaborate is the bit get stand quickly think talk a of here piece should trying of Thank et about very you're share? then in the But uptake against now. about relative just with of new on thanks lung launch going the how Great, two around seeing, through. you're we some how indications. to impact second-line more renal, Opdivo to regards little maybe balance of to and expecting, of a as business where prior think right type And dynamics melanoma the cetera, first-line second question we It's just that piece think play you're obviously in try other. the

Murdo Gordon

Chris. Great,

Obviously, of presence a I-O-eligible PD-X there the of XX% patient of population. chemo KEYNOTE-XXXG that Just PD-X result pool given lung, the a stable seen and as a of second-line is contraction on shares second-line around patients, approval. there, of we've monotherapy very plus of bit

the of I treatment pool the think in I-O eligible XXXX. that expansion most first-line will population of the in impact

expect So second I year. to stable our shares line for would remain in this

this would very option the at think and I melanoma. very really rest launch. in As days we second-line in good indication, now. our XX% early indication good X-week And It's it's adjuvant feedback I performance for and adjuvant. We're it's feedback. getting very very strong. to lung, we is a Q And XX% in right addition the Opdivo, Opdivo of very, look go compelling beyond the between the the I say treatment of been running look across though dosing of share at that setting uptake

to we're are continue Moving the the better. strong Guidelines, difficult beyond looking there We a in no penetrate, shares got from market which low days. approval. of And been our starting adjuvant low just And actually update we our in with to uptick In mutant segment course, we really NCCN BRAF it's to seeing off have of really baseline. but NPS, renal early that's part metastatic label so melanoma, population, the of the the some combination. launch, a has was a

So between that also I do there. evolution I at would continue second-line a type. would XX% well say fairly in to XX% expect rapid renal share we in and that tumor

become just of oncology have dose So plus of renal Yervoy. carcinoma much XX% lung little tumor that community first-line a a about overall read-through given cell treaters. will a for generate with a very is will Opdivo us, for important survival data bit base our being cancer that program of And the we realm a experience with low that lung first-line on strong broader in we treaters renal

but across and stable for very us, that this our are a good. the shares So we And indications pretty pretty strategic approval is important strong have. nonetheless, and other

John E. Elicker

Thanks, question, Chris. go we Lauren? the Can to

Operator

We'll take from our Jami question Rubin with Sachs. Goldman next

Jami Rubin

be think But not be well. – market if a in sort a Opdivo even market? is there Can we the are I is franchise I Obviously not, that front-line Thank there not understand the I participant market can in going sort questioning believe still is a lung broadly, some front-line bit place major as for on data disruptions to described a think And growth think and grows, be I you're still expected as the level think I a if near grow? term still And set a the the of are now. as growth lung, Opdivo that a then question you that reacted will a maybe believe or types, I be if think company. have in growth. front-line I then And story? assuming investors no unclear expectations the since to in second-line going market relates this whether operating even to Bristol sort what sort when can new from positioned due you Many new next last declining share franchise is that overall more you. it's bigger of overall, But to picture my Because the year. question. tumor about you debating I where you post-AACR, it expenses. think different of you is of just CheckMate-XXX. such from right the that of way indications, profile Giovanni, know to And lung, was

about guided operating you expenses. think had to a ago, I flat year

guidance gave make if And How expenses? beyond XXXX, thinking for Does XXXX. are You at it changed but to you wondering I'm very all. that's much. R&D that? Thanks increase sense about

Giovanni Caforio

thank you. Jami, Sure.

at let about cover the high So me level. asked you a areas

First Opdivo out the lung to clear, as But of be competitive tell do And continue want coming three company. first-line see I company, you I in point me my growth let And said of franchise. very as I respect as I areas. I I've see a acknowledge why. to growth cancer to With all, remark, in dynamics AACR. a BMS would to

is one our performance today. very and leading commercial first strong franchises execution of The

with psoriasis readouts are the These III trials that opportunity term our from our small is in clinical have, clinical innovative number carcinoma, the lung have III; of growth this which long Phase at and for that mentioned Eliquis cancer, gastric events. agents leading then And cell the The business, we'll with the with point Phase together to to number cancer, to into excited XIa position months, marketplace we continuing medicines including opportunity the move a into II. now data moving cancer. Phase important Opdivo. in Factor neck for and short and and the hepatocellular to TYKX FGFXX as the the including Janssen before three decision XX I'm agent, we potential the quite later running, We next for XX trials we and show important and then second all its catalysts coming to head term, medium advance progress; the year look in continue of

catalysts as the same we the at look the of far number the at the short the And time, company. in I think there and a the term, about when really term, investment way OpEx Nothing term, OpEx. important as really in continued changed are the to the has long R&D. commitment medium management So on

give Let me perspective some that. more ask to Charlie you about

Charles A. Bancroft

Giovanni at to committed highest as we mean, there's And year's year I you at pursue guidance, deal And opportunities Halozyme to operating be good and said, been our expenses Jami. in we time, with pursued. and year, look resources many Thanks, even really drive management opportunities refocusing that Yeah. and our recent opportunities. to priority strategically like MS&A BD opportunities continue if continue of last this our growth deals last other down, longer-term the Nektar the R&D up. same we have to on

we're focus So about those on of think aligned drive that strategically, really things commitment very value. we how our to

Murdo Gordon

they're remain I around patient strong done in optimistic Bristol-Myers early compete ability what they competitors the earlier therapy, do And, back from just with a the But indications future. organizations the having in deep and focused, these Clearly question what medicines this hearing AACR. effectively, a effects that of from the Opdivo it's that be are of regimen, potentially think terms shown I ability that received. given responses, to a lung role world perception see the associated Yervoy being sparing to and read, performance. durable the are. lives and proud I side and chemo and play, year those can to given a good in little will the strength there showing overall. medical about their Squibb so through Yeah. first-line on the commercial improve drive we've have, data we're the that just of plus expansion to of challenge than patients' new impact very things cancer. because We're post they've very the of remain have really we our the customers far, going And coming Jami, franchise be into that feel I I-O of your will I'm the position and do really to

John E. Elicker

Thanks, for please? can to Lauren, one, question. we next the go Jami,

Operator

with Umer from comes question next Our Raffat Evercore.

Umer Raffat

Thanks to CheckMate-XXX today. duration I my therapy do much first-line or instead Hi. some you you drove when versus the the for I seems for so broadly, squams And look can if really most you think the focus like trials at to in in chemo you we've duration important second And of do trials you my your Yervoy taking differences Phase duration on think the look finally, been previously in you. III is, you seen? one to – use the wanted I well? so the Thank guys TMB benefit it Merck's? question. of why first Yervoy confirmation wonder, at And do lung CheckMate-XXX irRECIST those scan has therapy see much have – has of led an [squamous] And has RECIST predictor of studies think TMB positive less of conducted patients. as was of in

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

addressing by are question. Umer, and how also excited point bit of of standpoint start data. want little emphasize I R&D we want CheckMate-XXX a about that the alluding just to to for that to from an talked I your thank that – Jami the you about some earlier.

chemotherapy perspective. on PD-LX histology, also something chemotherapy asked you comment is think over how to gone a importance two As questions ways sparing side chemotherapy nephropathy, that long, across and a you I've the are when effects upon how been regardless I of hard when nausea, to spectrum, of deep neuropathy, the find patient And past effects have vomiting impairment, about we've which Murdo are regimen. responses durable about reducing not said, are expression, from weeks. else all a And actually PL-DX cognitive – that of lot don't anemia, we these of the want chemotherapy fatigue, Murdo side and seeing tried mentioned, dependent entire – is sparing. of based this

really that important things I are regimen are it's about chemo-free a think important. to I So remember think there

actually of in And think therapy looking note of question very the And of And the part at is reason ago. the CheckMate-XXX. couple similar median. one our Umer, trials. therapy. two mean was chance, exposure, this looked The thinking of second on therapy. is this, of I I you – really Whereas your KEYNOTE-XXX did at posted So duration what a in your expressed it have about that in I days to is is points therapy the some a very, take trial, – duration second a look at that duration as between a study, mean believe a of being the was the that time the

that, As looking at difference. by term when therapy. X.X like there's therapy, to a as months, it's impacted XX% you And look know, the nearly is to the X.X median, folks, Merck mark of long Mean of mean we oppposed which at for is data something nearly duration duration very identical, when identical versus our the data.

duration of So I difference therapy. don't believe that in a there's

patients, PFS was months. KEYNOTE-XXX. And at at what our was very compares versus nicely you also EMPOWER In what non-squamous look outcomes seen in the seen year overall one survival non-squamous in very our compares the median X.X in fact, months X.X nicely with when in and

that immune-related RECIST I to criteria. know no RECIST really would look in changes We highly criteria. unlikely mention do explain question used way very criteria Merck although outcome, something of at the and I RECIST think. the used to as that. is think that There's the it subtle big and differences small I You could the explain which

a good That contribution Yervoy clear carefully are of are is two explanatory looking this. CheckMate-XXX we in I data out at be question be together on it's And think about how are I we making drugs doing not components. big shown difference turns And things likely think the we data could the of to turn a to then Opdivo for setting. major what's something really Yervoy that of this feel think have We finally one factor. is whether explanation the and the think both driving one out. on But that benefit, I

is You across as that also negative alluded and who the that are PD-X positive. to the patients, our we think TMB the as well both spectrum PD-LX showed fact that I of in certainly positive. And patients PD-LX showed true this Yervoy that was patients data, driving is we in

So, thanks.

John E. Elicker

can Thanks, for one, we Lauren, next question. please? Umer, the to the go

Operator

comes Citi. Andrew question next Our Baum from with

John E. Elicker

hear you, Andrew. can't We

Operator

your Please Baum, check line function. your mute open. is Mr.

Andrew S. Baum

Hello?

John E. Elicker

There you Andrew go. Andrew? right back question Lauren, the could go we'll log maybe if we to... can next and go in, to

Andrew S. Baum

it? Got Hello?

John E. Elicker

There Andrew. go, you

Andrew S. Baum

got You me?

John E. Elicker

Yeah.

Andrew S. Baum

KEYNOTE-XXX? This to we CheckMate-XLA, or and to be losing going that. about archival other be assets that OS CheckMate-XLA. on you're high given is liquid How And CheckMate-XXX, be going of then explicit assume and about similar looking you're excited that to IDO. sorry samples? expressors? some the to you PFS TMB remain Should Would TMB? questions looking in aside from Tom. you do you – prioritizing So PD-LX blood backdrop you Would allowing separately, be And mentioned

think used the write-down word a that, the licensing? or you there given with Will I be acquisition associated rationalization.

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

And And one really market saw seen to So, EGFR, year. you personalized makes groups. Andrew, let's you're role seeing segment, approach cancer talking to biomarker the a I in in over And terms little very question. the guide lung you're PD-LX that start high, important setting the been now playing a an being of see PD-LX to I've and I We medicine being year nicely. thanks important past people that CheckMate-XLA. said things ALK/ROS the for talking know who also precision difference. of high your we've about that story establishment continued I've of very going is for think were a We this believe that as past able the bit with an TMB in certainly to guys the

role. chemo So as that, a combo the of I do play part believe will

we're are combo see who makes see. that in The benefits. chemotherapy that to chemo the what I going early to to response where there are the patients that who could think a we some visceral have idea progressors, we And might vigorous encouraged KEYNOTE-XXX from even could more be data for a patient allow crisis, giving patients the have reasons circumstance help immune believe saw first stabilize that CheckMate-XLA. me

think response immune allow progression, still we setting. chemotherapy, from could of minimize attractive effects, I-O/I-O the a what of that in Opdivo/Yervoy, CheckMate-XLA option is vigorous two the which and with So the idea in I combination I cycles help with my chemotherapy combination, think perspective, is early very best believe side of a

Now we're CheckMate-XLA plan physical the at on not this point. going of to comment

have seeing in TMB look to we TMB patient to plays population, we this collecting this know, you out in population. As forward committed how and patient

But that plan announced will we do an survival as we in that CheckMate-XLA. and around have We statistical forward. know, important endpoint be overall as have optionality you move regarding

this – morning I blood TMB, see designation in about approval the to Priority not very – foundation biopsy. for was the light question designation Breakthrough approval or of the of given – compared was of it's a biopsies extremely biopsies Review liquid biopsy think it think to TMB the the I I fact timely. liquid excited or your liquid with that –

particularly if that's really I the that medicine. of of finding, you're personalized have great a assessing a committed to more patient's think genomics ways to we're going eventually It means cancer. even

as So very at being I positive. look that

we what versus to what of begin see TMB efforts in we in and see number liquid correlate specimens. We blood to biopsy have a

I would you complete. that I be less that process if than frank was I told think

this an correlate that's we the in to to in direction Andrew, to same I I But as this. begin have going reason process move it's ongoing every setting. believe, think that

Regarding – archival our other you're which patients being three to is question within for diagnosis, your of and to months now that see last the have samples, samples across me, I studies studies are think done the which going most the similar was other same board. will

to turn I'll it capital question, Regarding the Charlie.

Charles A. Bancroft

question the your that as Flexus Andrew, the regarding was asset think, time. I We an at treated purchase IDO.

anything – no regarding our is balance there on Flexus. sheet So

John E. Elicker

Can Andrew. to question Lauren? please, go next the we Thanks,

Operator

Our with comes John Boris next from SunTrust. question

John T. Boris

quite high Street One one general a see for stops an we expecting. that the on regulatory thing that is Review or anticipating or earlier, up you, just Thanks Tom, trial first level very indication isn't processes. for happening just getting questions, frequently end on materially you taking Priority the a

early? between So Just regulatory comments what's early, on approved general trials leading actually on to and that. that going are DSMBs some and stopping authorities companies

And Thanks. potentially Second very to do higher question Sprycel of then Sprycel? just Novartis. We weakness. Gleevec U.S., for Sprycel. this inexpensive, with the on leading Murdo. do because Tasigna segmentation has Is ex-U.S., some to just rebates weakness discounts being and saw market third question for to with We has from Opdivo/Yervoy, saw

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

just of is medicine. most helps we I'll presented that very the question. data England deep New this a strong, of that which your think for start and role Medicine, sparing advance new across precision point thanks really at regulatory Journal the and John, AACR. chemo Again, in responses, durable PD-LX out identifying the So, biomarker spectrum, we with And data off importantly, to this point. questions at published The

the you interactions As our with don't John, comment we know, on FDA.

that announce any any our in filings We are will assets acceptance occur portfolio. that certainly of for

the raised know, data as interactions when stopping I And I about you folks all can know trigger out are stopping. regulatory tell out. and processes. surprised often to are when when companies you the point comes justifies know and event-driven John, DSMBs other think comes data are surprised the and that these early, you are events because don't early the going the necessarily always also I you data investigators we

studies, obviously all we of that rules. across market Murdo? we our certainly important. those think triggered, and the have they're our trials, announce spectrum that's When stopping because in that we will early So to are have DSMBs of involved

Murdo Gordon

John. you, Thank

is Just different to what type, coming tumors. address market in from tumor the we're coming across rest the XX% our off, our first about business seeing U.S. of by lung, segmentation,

Yervoy, usage, it's on-label majority roughly much XX%. Yervoy XX% Obviously For of at in it's to off-label smaller. the is so melanoma vast

– it's going there, for business across addition for European we're going a was Sprycel of XX% we higher partnership. From differently. nice prescription really to bit XX% little the XX% different volume markets. approval just market. Japan, overall – for market our a seeing XX%, – And because in then balance have very European that is It's out. nice of in in a little the that's really lot market plus is indication. really perspective, Opdivo. a Ono no segments gastric good at reduction there business and And a and lung growth of lung And timing a PD-X, fact in the mostly in a function that which there's other well. uptake story. that's European is the in indications Our RCC a But in around play There are so very approval chemotherapy competition also one a bit about

myeloid stable between component in roughly versus of And significant lead are the market. the to imatinib shares, continue see we Our continue XX% we of at the line. to market. dynamic CML There's though, the or really Gleevec And of branded course good second no leukemia] [chronic demand growth. generic

John E. Elicker

Thanks, the John. go can next we please? Lauren, question, to

Operator

Our Barclays. next question with comes from Geoff Meacham

Geoffrey Meacham

Hey, the guys. Thanks question. a for lot

Just filing, differ, look did say OS change approvability? CheckMate-XXX, versus have relatively. I'm duration more is there a over receptivity response bigger that I in guys data And think, TMB you. -XXXG, your in of on at with OS. know improve to a KOLs mature testing? between couple. or Post-AACR, and does fact expect in you you And positions? follow-up or period would you when on confidence what obviously But setting. would this the time the And Thank then community versus CheckMate-XXX see you differences the seen have to European talking

Murdo Gordon

thank Yeah, Geoff. you,

biomarker unaided oncologists. And roughly back earlier we're and cell the non-small pre-AACR in XX% lung to have TMB market house. that's first that question, hearing XX% both academic research some post-AACR. roughly We've seen on I what back post-AACR, cancer. got from Just to we say as awareness I'm TMB pleased go for of referenced call an emerging community to your from in I with

So that's really a good signal.

equally lot AACR the was PD-LX. that was that importance not over of there that TMB. We important helped of the And of is of raise drilled a into out believe as XX% awareness physicians TMB physicians of understanding whether as that or noise So or agreed case.

on biomarker lung. oncologists attracting oncologists both think the So for community data of we're academic a useful as interest front-line the in and good shape I

different. when there hospital think I with actively very TMB biomarker commercial And the treated with interest, make a with TMB. similar that seeing is doing But tests also the are available. partnerships with we're go the what you go We we and majority treated you testing where They in as partners to for different work with companies of obviously little be the when widely we're the bit thought leader is internationally, Germany. a Japan we're do work internationally to who perhaps so that And tend in academic internationally. community. developing working exception is And patients each more well. already are of centers, market setting to

to more much community. TMB treating that optimistic interesting I'm So the is to starting become

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

regulatory we regarding on to I'm status. going your as mentioned So, to filing. not CheckMate-XXX on actual Again, question the Geoff, just second the John, comment

overall we question However, the that Because I is second asked. the at of that think with that of say just I waiting is, we're important. that's that really what you – question And your AACR part really second for you really is part would our data. survival shared magic

early, very Okay? promising. It's promising. but Which again, looks it very looks

of couple we I median duration of way looks hit in we you that our like that of when the haven't response. curve Now, showed, terms duration response even And that data with duration of the response.

know. We into Now correlate why it do the real trials. I does. in of that improvements survival? question overall don't is, increased duration That's response does hope we

you the you answer the wouldn't trial, knew trial. you of do And If a wouldn't do it.

other combination overall But the thanks response, point. hit one we survival that really seeing eagerly haven't just has an that survival of the seeing that truly But be that then actually that median and if EMPOWER, await have we mark see for If in is at it's conjecture patients, the So you particularly data. KEYNOTE-XXX, this for about duration But year I-O/I-O see the to of question. we look in better duration response, I the CheckMate-XXX, fact all again XX%. tumor seen could data, nonsquamous types, encouraging. as until

John E. Elicker

the Thanks, we Geoff. can please? next Lauren, question, to go

Operator

next comes Our with question from Anderson Bernstein. Tim

Timothy Minton Anderson

is between introduce is And they Roche or Thank battle of to mix. the lot from data combo. have a their CTLA-X But chemo you. folks trial. obviously of trying front-line the and The usually into focus bevacizumab combo Avastin

there's consider considering role to So there? on The to pulls? a there's no any Bristol's year-on-year to be will is as the basis guys think that valid confidence view what's basis is, Is really may the just front-line question and when answered can of trajectory or Do clarify. you or and which say you about in potential that role like the pushes and And but have kind in mechanistic quarter-on-quarter my of question – agent an with think beyond? combination annual that's you you a bevacizumab are of lung? something this Whether exploring? in second Opdivo, you you already, think declines that quarterly periods there all on a XXXX I something

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

with Murdo. start I'd to I'll the Tim, question So, then turn and couple over say a things. about bevacizumab it

population. cancer. increasingly And role, patients with data, outcome plays the that I Maybe have that bevacizumab I would data. bevacizumab First, a a majority conclusive post-TKI we I a intrigued would for But enough post-TKI to the to of data to for small more be the of the think number broad of think set in – eager role about patient lung contributing don't see out. pans patients, be by that the a that's role yet was I have small, in haven't what a setting. how Murdo?

Murdo Gordon

without usage a just I'm there being patient very seems to benefiting the would a say able from very physicians And specific lot is hearing describe to of not that disproportionately. be low that it enthusiasm I on Yeah, population, treating today. regimen.

Giovanni Caforio

many This franchise, we discussed and of continuing individual And a to what brands not a which performance a on obviously, going don't with is before – is to quarterly strong across diversify basis. guidance Tim, provide or is yearly of couple segments. we're I've on large its things.

a of number we the lot catalysts lung in a next XX first-line with dynamics we number in we are time, reading At I as acknowledge lung months. growing out same of a competitive other program first-line a the of franchise. and First on Opdivo the And see all, a have, data very large significant XX tumors cancer focused cancer. growth of to including do second, in

John E. Elicker

Lauren, question, we Thanks, the to can Tim. next go please?

Operator

next with Our Matt comes Blair. William from question Phipps

Matthew Phipps

thanks Great, taking questions. my for

First, sample for who you for TMB. in analysis? of looking what But get TMB to the do had was under kind just is enough can sample happen the patients that back and for think CheckMate-XXX – trial, patients number the you you find there about XX% Obviously, was of enough XX% successfully realistic samples. a

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

in question. I TMB were – thanks would XX% reflected setting. where patients weren't for Matt, your So, out, as again, valuable that point you that it say the and collecting for we

were XX% that very So in that think get we that I were we rate to actually setting. happy able

looking think I old XX% status. determine wouldn't don't evolved. that think have think you, to times were I you started that. progesterone school estrogen you're – about on is, sound able start to to want sufficient be to I seeing when the there unreasonable but at days prospectively, ER/PR collecting receptor we when have you and just know XX% And I ER I to if go when what breast tissue close we PR, back cancer or to numbers think I biomarkers expect receptor. how not think to mean about are just

crucial that how enough be to understood became in we to ER/PR. we treating tissue sure able we as so look at darn women's had made cancer, that And breast

the between but to largely evaluated, and So – test, it's is think when to think going see the going achievable. achievable. that to TMB XX% not And rate think success I biopsies. of little slightly obtain that think a I I time they you're be XX%, I that know docs, core get there, that's is Take

John E. Elicker

for Thanks, next Matt, the go please, one, the to question. Can we Lauren?

Operator

Gilbert Gregg from with comes next question Our Bank. Deutsche

Gregg Gilbert

that Murdo, uptake one And rapid and broadly Murdo Murdo, there in can barriers RCC no for space cost-containment us you this strategic size – are same are in you themes and the you pipeline, I-O changed there be for the a dynamics know Tom. couple And yet? on more. and there? out playing lot should or since I-O sure in questions I-O while pricing But front-line pressures CSO on to pricing in order you've in you comment to market U.S. pricing, to over maximizing let opportunity? A also confirm broadly the any oncology broadly, Thanks. about? more answer that pricing, priorities More or PD-X could the will And since role, or there at it's the about strategies can Japan, of and had diversify taking lastly, or Europe different I'm talk quite time? Thanks. Tom, more you've

Murdo Gordon

slower. U.S., Thank also XX,XXX into will to little RCC the patients treated slower take Japan, the RCC of you, progression In thing is the progress about is Gregg. Europe, of given malignancy, in out for one It's second roughly size five, so X,XXX. time more a Those And volume progress XX,XXX. estimate moving into top patients remember treatment In the about just of And second-line the are front-line bit it line. that population patient double patients. to about numbers front-line on will second a is line. population,

pressure strong the approvals melanoma UK. value are for the markets, establish value We [Opdivo would ever received evolve. our plus by NICE to all Then So of the business the Opdivo But I earlier a on Y of been on in because always very teams O of job, there's securing our fastest pricing indication successful indication plus in in in markets. There second-line one But to these the to I own in and Yervoy] unique from that take Opdivo fair say Japan. all been of Charlie, pricing, very say have will think line, our we've impact Japan a metastatic each think overall, good done and plus of Yervoy. major it's in access, I we was Opdivo while effects mentioned across as to international the markets. have price front

The our in other into our we've And trials. see incorporated clinical say set. first-line that thing reported RCC I patient you would is outcomes data

around think clearly level our to value look good but good forward. in not that least, And plan help we're working going going based patients to forward. with be affordable the solutions, us an at world treat pipeline, contracts to that find to going payers us of last allow you trials Europe. of across evolution And significantly do that will would I course we other the at as

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

a When year analytics And this so, call, ago going those to And I perspective let's focus going done in areas. last medicine, and three on following year two year, and And of exactly in on cancer, guys just to question Gregg, told areas. we're your think first work to focus you all to on of focus things to to were data told deepen the focus investing I my on we said on I you the translational biology we I diversify. the about we've that get how CSO came to I on going approach. and this three of our we're year. going we're just as

we've first on We The The TMB is as first look in that translational just in lead fact our this what we've accomplished identified year. medicine. we And Saha done TM what to brought a Group. in and another in able an flexibility biomarker, important at trial have in cancer, to a look important able be establish accomplishment. and optionality to and to the very that we're randomized yet biomarker large Saurabh lung

immunoscience is and in hard systemic at disease, the looking steatohepatitis. markers and inflammatory Second, lupus, Group TM potential working in at in nonalcoholic

the has extraordinary first in been company on had the So TM year. the impact that has

there's I-O diversifying within important. I point, Second that think is

I there lots ways diversification. are is think diversifying within I-O. One of of

by I BD important do what mean Well, two So that? opportunities.

by those IFM The and led discovery the NLRPX first fact of exciting move the resulted see And clinical into from development. molecule, that that very the the acquisition biology team, portfolio to STING molecule was to Carl move and obtaining area our in. Decicco, again to and be to system our follow be an the the able looked that's forward. deepen we at innate figured And immune we as we need

in that first, year, I-O. evolve. the diversification some And in then advanced there multiple CTLA-X, a to range compound has been there's more these survival within also think validated mechanisms that I I-O clinical And now of this But development. to outside are be TYKX. There to mentioned not talk. proud relationship three in Nektar Nektar. have very in has we of we've look meeting. that is is a t data we've Eliquis that a Next the more are that And shows But great IL-X. about compound And system. of examples exciting shown development Janssen. these then longer PD-X, seeing continues very Factor positioned Bristol-Myers rheumatology, in at psoriasis drugs eager as for targets, was relationship RORgamma targets And that TYKX improve saw cancer, Giovanni broad our very effective of all even to the his little what and drugs see bit time with it and with years now. data has upcoming past I seen I'm than could in three area a very other in we we immune that XIa, been presented have we're an drug well derm which Again, some you could excited come. again, our the to disclosed forward as FGFXX. be right continued take success compound think develop. to that advanced

John E. Elicker

Gregg. Thanks, please, Can go Lauren? we question, the next to

Operator

We'll Credit question from Suisse. taking my thanks Credit with K. take (USA) questions. Suisse Hi, Vamil our Securities Divan next - for LLC Divan Vamil

things Just want on, get clarification related. a couple to I non-CheckMate-XXX

those Opdivo lung whereas focus in the small-cell the approvals dosing comment if the didn't on the press there, on though melanoma talk where overlooked renal, was the U.S. Commission difference was and all cancer it you the approval but differences even the also But the is between combination four-week can, one, gets CheckMate-XXX for approved recently with only sometimes on side, U.S. EU, then and release filing And a So about monotherapy the looks FX, was mentioned it Opdivo/Yervoy, European study. the approvals. non-small-cell, much accepted. in just two that it broader. you Maybe the like on

else we're getting So the we have something for CheckMate-XXX you combination for or potentially to there? approved? data, waiting where can that Thanks. stand things wait on there the Do just comment maybe on is

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

I'll So questions. thanks for the approach two your question.

as accomplished the we dosing, move think is patients flexibility because happy U.S. you're time think I forward. gives very very tremendous forward. fact And a as renal the melanoma regarding the developing broad. that in Europe, first good it in we we we're start in And very The X-week and to forward that we that seeing And this about is it's flexibility data moves process. think look were additional real we're happy and doctors what that

filing monotherapy. Regarding accepted small-cell, was our that you for did notice

setting data small-cell, next year that have in one out this we also extensive early year, in this maintenance the seeing, and forward stages to earlier year, stage up We of one disease front. late look in coming

data. data confidence of own And of in evolution of that again, So pathway to evolve. and the continue But the behind to seeing develop a non-small-cell lack as small-cell. small-cell important in we again, this we look forward small-cell evolve no little our It's bit that data could also well. that be terms combination in just an

Murdo Gordon

interest in and And, take add then Vamil, steps two very dosing there's I the is X-week good seen we've would in only having have Europe establish regimen, dosing. to U.S. you dosing in X-week The your establish available. as that to you flat you the a have

some on those that's it's why across a So But to little staggered portfolio. we able other of more secure indications. the anticipate in Europe X-week being

So we're looking the forward to that market. as a competitive advantage in

John E. Elicker

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

Operator

with question David next Morgan Stanley. comes Risinger Our from

David R. Risinger

much. very Thanks

questions. a have few I So

show high, statistical the OS how step CheckMate-XXX potentially Keytruda very year? million data about then not show just financial failed yield the Thanks quarter into third, you possible what analysis, First, the you that? hierarchal we Could quarter, alliance ahead. respect second first of think provide respect PFS of sequential the on next the With And for partner year? whether in million all revenue or so Will will to combo $XXX the the chemo since the can in that just to was Opdivo TMB should question, that some comment with not comers' please. chemo statistically significant until could $XXX on color the any significance, for data first when Second, monotherapy superiority? up Opdivo, in this cut from to to be looking on we is component disclosure CheckMate-XLA combo? much. And a see

Giovanni Caforio

Tom?

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

thank questions. for your David, So, you

because hierarchy CheckMate-XXX The sat that a of that's absolutely survival, And correct you endpoint. and of where descriptive will what analysis. be regarding is in I question first the just mentioned, in think it which you're fiscal this

This of overall And analysis the again, data high to we So look that survival, TMB move yield right. you time a we will are mature even population. as descriptive completely forward seeing forward. with

chemo the is can see question when regarding combo. to on you data expect Second

an continues an is role, As segment. that earlier, I play as a mentioned area to cancer role, this we think will lung important still

of arm X across our Part remember, a you As study of spectrum has of chemo CheckMate-XXX broad combo a patients.

it We a expect probably it's that way But in that. upon you data that. again, matures. data the And how at look to know difficult to be to at very know out CheckMate-XLA will early – then best XXXX after probably bit that little be – depends

year, will that but the on negatives. Now, you combo in ASCO chemo will this PD-LX some see be the data at

I population. think before is more unfortunately, your to that Charlie? question the really information. XXXX going on patient have we're broader that And really focused

Charles A. Bancroft

book our expense. on for related royalties, million in Keytruda the And we of booked $XX those year. and David, royalties, other million last to we quarter, income which actually QX approximately in $XX Yeah, Keytruda compares about

John E. Elicker

Can to we go please, question. the Lauren. our for question, last thanks David,

Operator

Our Cowen. with Scala Steve final from comes question

Steve Scala

I questions. Thank two have you.

to company Do I giving future see simply minimum XXXX, in periods gave for First, of then a In guidance. growing in is specifically earnings Charlie. in regard, uncertainty, say? a prior year. it can future to XXXX? on question not early thoughts Or you're you the too for speak you earnings Giovanni, earnings understand XXXX? in But that And

the to can the in been in in months, tax downtick three in tax leading reform to Something was the other clarified the Thank in on tax rate, have important or aspect rate? seems realize the last U.S. tax you – But I there regarding of reform either as well. learned part. factors you. downtick elaborate earnings

Giovanni Caforio

we this briefly and in the guidance very on we early. very XXXX. for you've Steve, providing too good guidance. focused XXXX. this And It's seen very At not as results year, on discuss guidance on execution But point, very are are trends just premature clearly to good business.

Charles A. Bancroft

Yeah.

on U.S. Steve, the So, tax reform.

of real at was no reform, As top XXXX the which of on legislation. you with it know, simplification, was end very approved current actually tax tax the

a all So there through implications. of to was understand work to the lot

the rate that see on a in mentioned quarter earnings As did our forward. going benefit we call we fourth

the opportunities accelerate business as of were As our have to into legislation, we those to able we some particular it dug found applied of and that. we some

as is to what related versus guided, tax So benefit I as earnings the implementation would just originally mix. say three-quarters about far we jurisdictional reform related to

Giovanni Caforio

Thanks, everyone.

closing, across performance the just quarter was So an company. with let reaffirm, in this important me strong

your to discuss for the a very our call, medicine. I've make am continue in an progress much the with growth all during future. company significant confident we transformational We opportunities a And as for had with opportunity focus you questions. Thanks of have strategy against to on I as the

John E. Elicker

the thank Okay. call, And Lauren. everyone, up That wraps you.

follow-ups, we'll be any available. have you If

Operator

that for again, conclude your you And We conference. once does today's participation. thank

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