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Bristol-Myers Squibb (BMY)

Participants
John Elicker Senior Vice President, Public Affairs & Investor Relations
Giovanni Caforio Chairman & Chief Executive Officer
Charlie Bancroft Chief Financial Officer
Chris Boerner Chief Commercialization Officer
Samit Hirawat Chief Medical Officer & Head of Drug Development
Terence Flynn Goldman Sachs
Geoff Meacham Bank of America
Chris Schott JPMorgan
Tim Anderson Wolfe Research
Seamus Fernandez Guggenheim
Steve Scala Cowen
Umer Raffat Evercore
David Risinger Morgan Stanley
Navin Jacob UBS
Call transcript
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Operator

Good day, everyone, and welcome to the Bristol-Myers Squibb 2019 Third Quarter Results Conference Call. Today's conference is being recorded.

At this time, I would like to turn the conference to Mr. John Elicker, Senior Vice President Public Affairs and Investor Relations. Please go ahead sir.

John Elicker

morning, good and Augusta, everybody. Thanks, discuss We're earnings QX here to results. our have our we Chief Chief both Boerner, have me and Chairman Commercialization Financial remarks; Officer; Chief Giovanni who'll our With Bancroft, Caforio, and Dr. Chris Charlie Executive Officer, prepared Officer; Chief Head of Medical here will Drug and well. as Q&A Officer Hirawat, Development be Samit for

I'll legal first. requirements the handle

those forward-looking Actual company's prospects that and as the we'll results differ of factors During may plans various call, these SEC make in including future statements indicated materially result a those from forward-looking statements the about statements. by filings. the important constitute company's discussed

any represent These to even statements our our statements not as update be estimates of upon if change. our forward-looking disclaim today estimates and date. should obligation estimates as future of forward-looking representing as any relied specifically We

We'll comments also website. of most are at are financial adjusted items. measures financial available exclude non-GAAP comparable measures which our Reconciliations certain to the specified measures these focus to on GAAP Giovanni? our our

Giovanni Caforio

Thank we important and about pending in franchise, for made with oncology quarter speak close another to and performance, great I'm you which everyone. you, our pleased acquisition companies. good strong significant new of today operating and reported data the John, the Celgene integrate progress had to morning, two

cancer lung combination PD-LX believe lung in second first-line benefit for me with in survival an and I low-dose Let of population, trial we play our histology. status program. important regardless demonstrating or our Opdivo+ Yervoy the franchise role have recent oncology now for overall opportunity start We cancer results we the of have first-line an lung announced an cancer. to a

our in the I CheckMate-XLA coupled first-line with commercial see lung good maximize market. we our the of and about the results strength both the to ability capability, cancer With opportunity feel XXX of

in first-line our potential contribution Let comparing And is dual lung the important. that and a that response studies. survival lung told Opdivo+Yervoy we have a for I-O CheckMate-XXX unique offers of me Physicians in Opdivo PD-LX findings recap cancer saw recent us the when to we've long-term quickly monotherapy depth two of parts from With learned durability cancer. expressors. clear

saw also the chemo outcomes PD-LX negative PD-X in combination overall better than Opdivo+Yervoy survival patients. We has that

it As at regimen that in feedback our ESMO view physicians. described lung we treatment in cancer will the September, and supported Dual is of is a I-O this the we first-line the role by received have from play

progressing chemotherapy. some also know patients to rapidly cancer lung We that first-line disease due need

whether limited A of allowing two curve, key Dual potential those question determine a for early part chemo to the I-O. of durability amount the for stabilize cycles manage to would of be patients the the was enough of for CheckMate-XLA study and the effect disease

benefit concomitant meaningful survival We are pleased positive with from from demonstrated with interim CheckMate-XLA which course analysis limited chemo. our of overall I-O a combination a the

We expect XXXX. likely in medical to report this data meeting at an upcoming

also forward soon. findings look with health We to the sharing authorities

new benefit At also tumors that Opdivo+Yervoy ESMO arrangement. data the difficult-to-treat presented reinforced and explored approaches of we in important the

melanoma. metastatic we first-line cancer overall data Opdivo+Yervoy our to addition data, five-year In survival lung presented

cancers. We data important and also cervical, prostate, types including other esophageal presented for tumors of

next indication development We more data ESMO And future beginning readouts program, patients. to continue I-O looking to to of use forward breadth of our broaden data a see year. presented our medicines to including the is opportunities the adjuvant good in I'm benefit I-O our at progress. of

development for his Q&A. with the is mentioned, here As as his Samit organization portfolio share priorities He us the full John as the during on well can Hirawat today. perspective

let me the turn Now, third quarter to results.

our portfolio. results, commercial We by continued to deliver excellent strong across driven execution

moving significant for in of global established key job show Eliquis is market care. for growth, able indications to-date. continues profile done the product shares a have as strengthening the Opdivo expansion already very standard we're market Eliquis globally, teams in strong to is The competitive and to as forward. with Our great potential a maintain

presented we data provide performance the French ahead. best-in-class our ECC, real-world potential in color the at opportunities on more quarter we Eliquis' quarter the Charlie set patients, largest This see profile. of will which atrial confirmed and fibrillation that

Turning bring to patient on our two transaction a we've I pleased innovation leading with with through the progress companies, shared significant Celgene, science. focus made by am to transforming together united lives

the business has transaction on deliver And has strong their been results Celgene the they priorities. continued to for While third announced today, pending, quarter.

a myelofibrosis. Celgene Celgene's approved encouraged or with see CC-XXX on progress the made the in also The treatment to pipeline. Fedratinib significant Inrebic the decade nearly late-stage quarter, the study We FDA patients were During the for of leukemia and new in as planning first Both for myeloid integration. of patients I am and the proud delivered Celgene. at Squibb same Bristol-Myers meaningful closing people time very option. and looking made progress acute transaction for teams the terrific success at towards maintenance quarters a

$X.X synergies in rate billion XXXX. Importantly, cost to track expected the we run by are on realize

we quarter, milestone two is in key our In for third approval the of agreement complete We the $XX.X in close billion we Celgene transaction. to the the European process in following August, an During announced Celgene OTEZLA acquisition remaining to divest between the milestones the cash, the Commission Celgene. FTC Amgen close received of clearance to regulatory transaction. July. achieved from and

Celgene before end XXXX. expect complete and Squibb to the Bristol-Myers the of to continue of combination We

the focused with building we this combination patients, company, the our goal employees the our our on and delivering on for the In organization of structure are promise new of shareholders. of meantime, the

working ground running leaders in of that team leadership are September. the the we of on day hit now Following my announcement to June, we internally for in the ensure announced future one. integration, next on preparing These layer management

patients. like our plus program, to options potential opportunity announced reiterate, new arrangement benefit remarks, continued of pleased am by the strong by I'm lung how the the I'd Yervoy with Opdivo To performance. encouraged provide conclude enforcing in to I and my first-line low-dose we our to treatment results the

support more are performing is Celgene businesses Both pipeline combined move the seen significant Commercially, and ready at I'm as and to to the on looking ability multiple execute ASH. forward of a have for are regulatory to progress. opportunities we our track I completing to well, we and excited we're company. combined even integration the closer the we progressing confident As company. transaction, in clinical launch news potential I'm the more future about am

over that, hand Charlie. With I'll it to

Charlie Bancroft

important closing Thanks, morning, another continued towards everyone. good Celgene and Giovanni, and We with good quarter had product progress developments, acquisition. performance strong the pipeline

start Let's I-O performance. with

to continues very team maintaining strong key share indications. commercial well, U.S. Our in execute

and As expect off it the has our trend towards end quarter. expected, of continue to to the declined of during this continue lung been size we the patients to the level we This line see with projections second-line pool of eligible year. in

care first-line in and perform continue space, RCC the poor standard a to In remains patients. Opdivo+Yervoy where intermediate we well, risk of

As TKI I-O TKI, we've the expanding monotherapy. in at combinations the are expense of described I-O, use past, of the mainly

in quarter. However, for Yervoy of sales the has some been movement patient as attrition affected This QX, mentioned Opdivo+Yervoy. during U.S. with combined we new there for the share unfavorable inventory

the Yervoy pool I-O melanoma as we front-loaded. remember expected. in with as RCC variability the that the lung is good patient Internationally, declining dose launches renal schedule to in to than more Opdivo see in such and U.S. is continue sensitive performance adjuvant Also slowly first-line we than second-line more because demand

Eliquis. Turning now to

delivered growth of profile commercial Eliquis of the demand the revenue care. the driven time Our execute very year. compared XX% last U.S. was standard quarter. we the the scrips to establishing to globally generation well global Eliquis In XX% This teams by continue with by differentiated significant in as same leveraging growing

the net donut to expected, from saw the quarter. hole increased we gross As revenues during impacting

the from years, significant in QX. hole As in we prior expect see impact donut to again a

Internationally, build Warfarin anticoagulant we France. countries multiple momentum the to while overtake a Eliquis in also such one countries number as to as in the strong outside is continuing U.S. saw growth now oral

During the continued saw quarter, for the stable demand Sprycel we in U.S.

in inventory down the a normalized last levels work occurred to So QX year. significant compared have that

items some royalties. during the the quarter. P&L as benefited mainly higher in key Other line and expense fees in from income as well Regarding licensing quarter the

approximately we one-time quarter, XX%. impacted year tax rate in tax was favorably of in items our the Our rate full by which guidance anticipated

we've of today BMS non-GAAP the the EPS our Based on a on updated performance business, standalone basis. for guidance

has ahead. noted, For company we have as the Giovanni combined significant opportunities

the be after the to closes. for in until we company some a deal position point So provide guidance won't combined

starting product in headwind mix the me Let the of pro P&L, combined mechanics forma on This the the of compared margin. gross products will dependent Eliquis about with some remain you of the for remind a other portfolio. the primarily be will company. to continue example to

non-GAAP back stock-based Celgene's be OpEx, the consistent to company of compensation BMS it practice. with Regarding the OpEx the combined to important add will

roughly expect of also year. realized to $X.X next synergies billion the be of We one-third

as compensation, the year company, this including dilution the After earnings the the combined company at debt will well the shares of from P&L will existing rate from the the we moving power look include by we the average of outstanding of count of interest for as at Celgene very accretion stock-based number the of and partially raised for expense the are When acquisition-related increase by billion earlier debt combined ASR. at we the encouraged $XX companies company OI&E by offset an close, share forward. close, X.X%. from both

new cash balanced initially allocation, in flow and company. first of free years capital to to billion to We a continue for the we flow the of combined capital plan projected see significant generation the allocation. we Regarding three excess for $XX company approach cash over employ

to cash will the slightly expect absence basis This $XX.X be flow operating we billion, a on cash OTEZLA. doesn't the pre-tax of sale free So from include receive the to flow due lower from Amgen. to

central to investment-grade avoid X.X at delever, The innovation. be me excess strong invest substantial commitment to and initial near-term fund OTEZLA The increase times the will Reducing achieve debt-to-EBITDA debt will reduce allow XXXX delivering dividend, is leverage. gross excuse from than and -- delevering maintaining prioritized proceeds in less on to our cash credit us the debt and ratings. to flow and generation ASR in

track financials. $X and We billion increases ASR evidenced We've expect increased of as record execute remain we've close. to dividend annual dividend $X modeled proforma our the we our after we've as mentioned, And the by ASR increases. continual XX-year in previously our committed to to billion, from

We in flexibility. debt development the we the near-term sheet and in balance continue early-stage deals will while be rebuild reduce to business active on and smaller focusing

well next business companies, following company we've the positioned are during operating close, the for quarter. as momentum to strong on good both we combined embark chapter a very And close. our To had with performance

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

John Elicker

as Augustus, here Q&A just session to might we to both Charlie can are Chris Augustus? addition the now. And answer you Samit to Charlie. Thanks, any questions And a reminder have. and in got and Giovanni

Operator

Terence question [Operator will you, Thank Our Flynn sir. come Instructions] with from first Sachs. Goldman

Terence Flynn

question. Thanks for taking my

some trial the that analysis? unblinded on reasonable are data PD-LX than CheckMate-XLA assume the PD-LX Just patients to think it's Last then to both data plan -XXX said XXX? data if these question, just stronger relates than file next across quarter, wondering, wondering, given the interim and I for you then is you're an to I if And expecting negative separately pressure the had And the XXXX. Opdivo year. second

any third data there growth? can the Just clinical and trends you. updated recent quarter thoughts Thank given you for the the outlook share on

Giovanni Caforio

you. Thank

obviously on strategy. So, regulatory interaction to as regulatory with comment going authorities know we're you not or our

we and performance. data obviously the on health Chris results mention, are a around Opdivo data perspective from give XLA did authorities we As will Samit with comment on the sharing on the you will world. planning and

Samit Hirawat

results into reiterate, of trials Thank putting we had plus Giovanni in you, bodes for to of that Giovanni. the think are the beginning And nivolumab two combination already what positive certainly well said the the happy truly ipilimumab. XLA perspective and I with just

of going upfront rest well the part outcome outcome the through meeting able we can safety chemotherapy of impacted. cycles ipilimumab medical might are when nivolumab present of curve as to data right look curve. to I be of low-dose the and overall in it we And to as future if two the be combine and the then the the how curve terms combination in early with for the carried of management very be at then to it's to patients terms in think when understand important at efficacy,

and of But versus to We Chris on not our XLA me what plan analysis of are more itself. comments. convey time comment filing. we comparison this as it can't will pass We terms biostatistical at And strategy the – comment obviously of about for the Giovanni cannot regulatory let to Charlie compare in results on XXX. said, the

Chris Boerner

data over Yeah. a that Thanks few cancer obviously with saw the the front-line very Terence. the in standpoint last weeks. from commercial We're pleased lung we

to Looking commercialize and – looking also for much able regulatory we're will the forward in and discussions lung. very to being first-line take ultimately that place

and U.S. see XXXX. still though pressure the timing competitive those under the do Given in the we dynamics of regulatory in interactions, Opdivo

continued dependent based the to beyond we've data new XXXX about we the trajectory consistently, pretty seen feel strong growth And the in readouts, to thus be execution growth of indications. upon we've is teams, going commercial our good far very as said However, on and of returning XXXX.

continue the that renal and be readouts data in setting. XER will growth in CheckMate-XXX. to gastric of first-line Now Those from cancer a esophageal shape of in CheckMate-XXX the function first-line include metastatic additional first-line

include read we also XXXX. those adjuvant of those begin to then, neoadjuvant All gastric melanoma will out to XXXX-XXXX. in and cancer. bladder as read to And see in programs you know out expect lung And

John Elicker

Augustus. you, Can please, Thank Terrence. question the to we go

Operator

Geoff Bank Certainly. go Meacham next to We'll America. with of

Geoff Meacham

for thanks Just the had question, of couple guys. a –

the guys in expect are Chris have then I-O second given early first-line to But lung competitive let's assume tick during reasonable market, just a are renal with know I as digested want and XXXX what earlier, rolled the just to for the say marketplace? offered the of on a second-line And up half perspective a the quarter? I just out you. prior a interim data sense to comment XXXX trends. follow-up guys dynamic you it Thank On get for the what from first-line the refiling, and you XXX on trends seeing versus a the in is already for just XLA look

Chris Boerner

Yeah.

thanks So Geoff.

regimens the the start first from the Let of of those Obviously of me we post with year, had and part impact just TKI the in launch half year. in competitive this I-O earlier renal.

coming However, over I-O number has we shares of last shares And renal number say frankly on I-O share actually seen really as is said population, as at today, as take stable was The the in I would to seen share mentioned renal that been what the result monotherapy. class TKI the look XX% and earlier months. our been first-line TKI we've range a label XX% our in that's the I from around in But that's we've months. in relatively our growth competitive XX% XX% to mainly holding last that. of as consistent first-line of over been holding

XX%. one renal in our from, But in share, We that line see line second eligible the lung to second to a first-line keep respect dynamics. With example, I in plus lung to roughly of the that the do as in think at now of pool decline market in in second line is for see there's see date thing as different non-small in cancer mind second result right a the case obviously, cell a role least in cell renal line and that's you cancer. you least is playing first-line while Opdivo And, at decline. And eligibly Yervoy not in also that's setting.

gave just and for XXXX I and growth answer to the respect question. in then to XXXX, XX And I I Opdivo think would -- beyond to back refer Terence's

to XXXX do out But interactions. I under think we now, timing the think still right continue to But beyond XXXX. metastatic play and will and see the we XXXX growth for how as have see Opdivo a respect Opdivo certainly we I and with pressure that we're to to programs as very brand. see into dynamics out going read adjuvant regulatory of much get

John Elicker

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

Operator

JPMorgan. Yes, from sir. Chris Schott will with come That

Chris Schott

Thanks much. Great. very

about talk at picture the in bigger point. Just you just first-line this maybe But a realize XLA Yervoy I coming can't Opdivo back lung, to data question.

as about Opdivo to role induction alone chemo Yervoy by you just the dual strategy. As think followed of I-O compared

lung? want of looking those front-runner you of, At kind agents profiles optimal the other? to what's terms see Just in in the just get of really to really front-line relative profile be -- one one out going versus more, do to for qualitative this is point those the treatment sense there standing of at other is like

to leverage XXXX? we hands Thanks the know a turning looking I year longer sale debt where you moving leverage company at is back as get My of and second deploy much. question expected you can can this think be term talk But Should targets. pieces going over your to balance a profile was we we about your about the the quickly sheet the leverage. capital again? at few et my how been and course on look cetera, just point -- with on there's OTEZLA so

Chris Boerner

take context unmet significant still Chris, as And as then of is question conversation from see lung for the turn the first-line The I about a and cancer much way maybe ESMO, first recall over you can we I'll Charlie we to the second think market question. in frankly with need. very had at it we XXX. your XLA,

majority plus see had going within of a the with I-O conversations on they standard are and since that treated relapse the things. example, certainly into year. ESMO, patients For the few going physicians a to And ESMO with based chemotherapy we

duration need options And those very second, XXX curve they the for patients there's considerable they complete additional I-O XXX, importantly for for who saw overall or First, of survival with safety see an need in important profile cancer. compelling. unmet response rates impressed that of see providing they view the they the chemotherapy. option given dual with and the tail They're from therapy. opportunity don't the a first-line want lung is And is responses need manageable

do data. I-O this require and the amount therapy. about dual XLA chemotherapy. really just the value top line of it is chemotherapy adds we got is a patients Obviously cycles two way does What think The we for case in who limited whether question to

can't on that. so haven't We specifics, gone through the all comment we

remember and Opdivo is, or we PD-LX we what trial for study overall we're an And second very the have demonstrating regardless was a of can that benefit low say status was histology. dose a of that this pleased However, Yervoy. combination survival

of gives opportunity and do to the organization opportunity with commercial that to and XLA do we can so. a believe much strength capitalize look And that lung cancer us the coupled and one our in first-line XXX we we real forward very

And so with Charlie. over to that, maybe I'll turn it

Charlie Bancroft

Thanks for question. Chris Yeah. your

As our we've deleveraging let stage balance sheet flow included we've in our just through dynamics I talked deal flexibility early in analysis. really and my the to about is me walk talked already deal during you important, about back overall in and cash mention continued But math. of getting as kind is comments the although,

We've has billion have Celgene talked We know. that. of billion $XX out you as X. outstanding in in about already taken loans debt $XX

have $XX billion of given a cash which debt, we flow So XXXX, considered the and less in we'll combined at company the significantly as than end originally OTEZLA is generation. sale

As XXXX, expect we about debt-to-EBITDA we exit to X.X be times leverage.

John Elicker

questions, the for we Chris. Augusta, please? one next can go to Thanks

Operator

come with Tim will Wolfe That Research. from Anderson

Tim Anderson

Staying my you time? in It's you. terms on I-O biggest among Opdivo in Thank with will it been analysts brand the competitors. second the tables the remain most think second confident the space league Opdivo. that I remain Street Are in will is spot that space that Opdivo assumption, of the in over

look been confident you're an out And company at I'm knocking program. They've I really you if and consistently example. seeing remain trials that like wondering in that spot. uptick number in the for you're a two Roche can

PFS as about, you you've to well trial going that benefit, do question, show be XLA, to benefit a have not think an only talked back benefit OS to PFS a meaningful? commercially Second for but you that which

Giovanni Caforio

Tim. you Thank

ask Let to and further. Chris me then I'll start comment just

marketplace we feel strong. with every very we where performance We've we demonstrated in ability just are is get. me that The about our to say the maximize quite let opportunity good So, Opdivo.

first-line we important confidence very in the we've setting, very, that the out in that the I-O with have rest Now opportunity the I a overall us important past, program third Chris? compete disease. adjuvant metastatic to the we for in advantage Opdivo Opdivo about a the front-line in as It's of is think well time as are of studies survival growth play cancer next a the XX setting XX as in plus our next an I gives really to regimen. that real think differentiated role That have there. positioned for that Yervoy And we read an lung in said, wave to then months. said

Chris Boerner

Yeah.

what the have So kind thing I Giovanni is I I Opdivo I think really that we of I mean say think highlighted about separate XX overall. only that is remember And to think how indications. would would add has we

important indications majority have of continue an promoting. in leading in We which vast to and share we're market the

Opdivo good well that lung opportunities opportunities as feel in growth So pretty as but not have setting the sits we well about the in the into as setting. with also in metastatic the -- today that readouts results adjuvant data the light additional only seen we where of as we've cancer,

the Roche, start you those read ratios see from of and the at to have Look, and respect broad of in the there that across increases subsets. rates ratios you not for regarding within all your if that in variability With only durability respect to to question as specific hazard to data specific across Merck of target OS, well studies, from cancer as out that the studies or our be terms and PFS would we response first-line fairly hazard range with response we read I've as out look a XLA whether of that's and studies, that lung for looking hit competitive. you there's and data also a the range look see not but you

opportunity that is role play therapy readouts I-O XLA excited data lung the the going actually XXX need is to in of So that this that cancer. presented are with first-line a back spite based significant strength those overcome. and in What about about to a see all on data in to we we're played market very the what specific rate play. us. really setting There's don't the have we to think in was There of we of much hurdle have dual physicians for

of and have. the organizations, And to XXX medical those we're not excited has is about XLA may we role given require potentially the for our patients opportunity I really who with chemotherapy. important do. for patients pay commercial that As a who strength earlier, mentioned along those

Samit Hirawat

this Samit. XLA more is survival. in to And And remember, -- you that trial just overall add couple a the if points the primary Chris, endpoint is just

include does safety, of endpoint response, cetera. Secondary PFS, et response duration rate,

started study we part only that, end of enrollment XLA in the at XXXX the and in is point the this of the year. Second finished early

follow-up is and mature. relatively evolve a from so data So duration short this to perspective and the continue

has saw said deeper present the we we as we line earlier, And just more at the and Chris top data to data next available it, year. as able into some time. And data we'll dig more time this comment as is be

John Elicker

Thanks for the questions, Tim. Can we take the next one please, Augusta.

Operator

Thank with you. come Seamus The will next question from Fernandez Guggenheim.

Seamus Fernandez

Thanks for the question.

one on perspective. an investment So just from question

worth think you a Are the you see going you behind triple As results, stage Do to strategy similar trials strategy opportunities strategy a you should dual talk cancer, beyond to invest type other regimens us guys basis? about similar see would behind I-O/I-O the it about recently, opportunity to a adjuvant types or where as an perhaps lung in on the to behind XLA more the invest the investing about tumor this can there in three you that we forward? see started combination even setting? setting? Or go-forward competitively more think

little Thanks. IBD the you're XXXX. think TYKX The help second of on XXXX, inflammatory IBD bit a the coming understand and psoriasis OTEZLA you think efforts rebuild presence to the and just opportunity some in kind about Chris, going transaction. not to you question Can the in sort is because ozanimod psoriasis space other assets about that across the us your of the of through as exiting also also we as but of just more prepare in conditions, you're

Samit Hirawat

question. you Thank the for

terms -- chemotherapy. me from just take nivo that the asked and questions Let the with two it the with of in also you've

in You the and and in hepatocellular that ongoing esophageal of the nivo-ipi gastric in mesothelioma see have setting will chemotherapy cancer we standard cancer and cancer III chemo carcinoma. CheckMate-XXX bladder Phase trials versus care

to in continue we time develop course, forward. additional continue of XXXX for this going will where opportunities frame. then And data look can to these All evolve combination we'll XXXX,

in will trials able the safety low-dose and grow. continue confident now in we manage using of many quite experience these ipilimumab, are are be to of also that we'll because the as We physicians to well

which OTEZLA space, you we inhibitor. On space TYKX effects that the we is side inhibitors know your differentiated certainly activation versus domain its see. which psoriasis looking are the that second regarding divestiture from are inhibition excitedly specific doing TYKX the of downstream we to related what of leads effects question through not forward to quite has in as JAK and to the to our are multiple many

The TYKX Type II therefore inhibitor that was as and of target in or have that the dystrophy well to is domain. been signaling neutropenias IL-XX the IL-XX, we specifically pathways. is have pseudokinase causing designed as quite the the does BMS-XXX its interrupts it safety efficacy seen. very it What that of which And it's interferon specific the not terms

as other II where end and early XXXX So we're well as of indications studies looking towards towards the the Phase ongoing well as psoriatic the in readout of the Phase as in studies III that arthritis are are ongoing currently IBD. XXXX

with the You already program in Phase III ozanimod mentioned IBD. well

me data towards to forward as well XXXX looking seeing let we're additional to to add Chris just that So pass But on comment. end.

Chris Boerner

Yes.

think a just TYK Obviously, standpoint. million PASI data patients the program patients. of the add order efficacy in EUX oral. the with on be we've we TYK commercial Let you an going XX as response This opportunity. know that play you're safety very And X.X psoriasis. That's important on who for very seen is coming a like role an indication is a big exciting. score, the is for and The large opportunity and for Phase biologic few that those based with as out but from the of a Japan U.S. things initial a is to with II XX% the rate convenience the looking of are psoriasis will in aware, me prevalence a

because large have safe still TYK. of that patients very previously, efficacious systemic majority really treated the we've a obviously, the are disease. There we market, are those of X.X lack therapies discussed not this IBD And about $XX the products. and And roughly ultimately that's as billion worldwide. opportunity first vast with just is million diagnosed with with

terms from BMS it The way an we're building And this MS, broader IBD a the obviously towards we building remember, in look team opportunity. do number Obviously, but on we have Celgene immunology. a history has out an colleagues in commercial standpoint with there's initial eye our one, the working today. at ozanimod of out focus

we'll this we So company there. combined we that's obviously space well to and something bring a that know become as

So a these we'll that on be in actually capitalize to I'm confident opportunities. quite position

John Elicker

next the Thanks, Seamus. we question take Can please.

Operator

That will come with Cowen. from Steve Scala

Steve Scala

provide in because Charlie, key did you closing. did of why you high? or consensus the past you now is combined the it think you aspects too upon curious, the versus much. Thank so I'm P&L,

raised and been the I a be will XX%. guidance QX will very good EPS down X% it's QX Second, Why might down if That's so be EPS year then striking And precipitously? Sumit. because implies full year. quick between for

we KEYNOTE-XXX relatively follow-up XLA a Thank XX was said, You of median with hit XLA? something should similar assume XX months, short. to for you.

Charlie Bancroft

Yes. Steve. Thanks,

modeling, some in the some So weren't just in regard as There compensation P&L. analysts we think perspective who about particular. on particularly combined has been to giving stock-based

the in how to more bit share we we're wanted get So it count. little we handle specific, to to how going think addition about be to a

regard to the that's there's In So I quarter, number fourth play. at a of things fair. think

have the -- Opdivo the on we bit to fourth and fourth the quarter. historically continues -- in about get think related in in business sales the little talked larger, more we've as ELIQUIS we coupled -- flattening about we the we've of quarter. UPSA slightly in think a as you as fourth we before of July. call we've That into with about business got quarter. third to as And The this donut the talked business hole the OpEx If always already we -- the talked sold

Samit Hirawat

of question terms in the And around XLA.

not trial we will cannot to will we presented comparison And at course, seen to Of how including what obviously this time. at compare any have of other terms be in KEYNOTE-XXX this time we with this KEYNOTE-XXX. the the compare, results

John Elicker

Thanks, Steve. take we Can please. question the next

Operator

with Umer from come will That Evercore. Raffat

Umer Raffat

on so Thanks two me with question I my questions. Hi. bearing for much appreciate and you this taking

the isn't whether MI chemist be or patent it is to My want question learn the touch make calls. on ELIQUIS? salt from secondly, in appropriately realize the there been My a First, straightforward LAG-X Thank for a half the been melanoma of the internally? randomized II in very not. form on topic I trial we as readout forms it is has your trial, that And component much. much you is able chemical patent regular on to question litigation, specifically a tied on Phase fairly salt this are the II the a there's second for up ELIQUIS doesn't come XXXX. given I there's very there in structure, Phase of a up and know confusion of readout I description marketplace to III written the relates ongoing that? this can randomized there Phase of And anything to is,

Giovanni Caforio

Umer. Thanks,

answer just your ELIQUIS pattern first. me Let question on the

So a of things. couple

for of First all feel position we the very IP about good ELIQUIS.

and that in have news have fact couple the for fact That of the settled order I remember I really position. already we patent. can really there IP the dozen the regarding XX days. the of patent just are a challenge that two with continuing may Samit our a on... the generic to number has feel last today. are strength that think good that generic of ELIQUIS us some companies about been were to about a we There an scheduling testified strong ELIQUIS. You the of very trial companies They of starts small estate say to over speaks issue was that challenges IP witness And there out was

Samit Hirawat

Giovanni. you, Thank

trial as at a It's metastatic setting first-line a Phase In for seamless terms know LAG-X the versus trial nivolumab combination looking of nivolumab it II/III LAG-X study. is a melanoma. you in plus the of

to So available The seen not of end enroll towards in And as trial the we patients pointed continues already have data. will be study. XXXX. out data our you the the

So to at communicate able we'll be time. that

John Elicker

take we next Can Umer. the Augusta question please. Thanks,

Operator

from come Stanley. will with Morgan That David Risinger

David Risinger

Yes. Thanks much. very

I So, about have trials. a question future

understood had triple looking cycles with including we was chemo chemo, priming therapy and XLA Bristol chemo. but following Yervoy Opdivo that sequential at or was therapy So two of

much. the us about watching please outlook should just that in the or think second, color Opdivo's with remind very then some you Thanks registrational do on should could U.S. chemo trials for respect you So with we sequential XXXX, we therapy? how to provide ex-U.S.? momentum any could the you to have And priming be relative in future

Giovanni Caforio

question. chemotherapy, about and the Maybe, at looking Thank think followed in the the future the I-O that and the for by by chemo such. take terms chemotherapy the followed trials I-O or I-O can current I have trials as we one first you of At sequencing how sequencing. and we are of time, don't

at. second at an that it's explore in new planning to looking this future the idea with that we that in we future, but registration may will be time no I-O yet generation be we looking are and this that third we're And to certainly sequencing. trials and trials have the the there compounds But developed

Chris Boerner

let David, comment on me just Opdivo the question. And,

to respect to and a continue versus opportunities with U.S. business really the of U.S. the based see So on of to ex-U.S, we things. outside that's grow couple

timing core line our renal of as our business well of as cell strength ex-U.S. in the lung the countries a tumors, non-small First, second across of melanoma number access cancer, and

we U.S. a And looks that's neck describe two is And primarily under as head, small cancer, like. previously. lung pressure me competitive as, and let as well of really, other what cell. across The that mentioned dynamics function indications

of about in it's the So, second-line situation We really in in decline our at in setting. today. first-line approval pool with cancer cell agents in the in this dynamic line. That in has function talked out, of eligible the of lines approvals bulk a have length earlier competitor with first-line, lung continuing three or with the cases, in all year neck head of later and a and playing eligible approvals the first-line population is second to I-O in where played Roche's in we out, those business small recent decrease same

third What eligible shares are all maintain it's we leading of cell Again, expect we those a year. will in -- and and our within second neck and across continue pool share and markets. be those, declining albeit, however, in is note to in pool and a that stable I the to declining small a eligible second line, in in stable of head three function line, indications in both next of those

John Elicker

Augusta, like have only we in the I looks guess, And queue. it Dave. so one more Thanks, question

Operator

Jacob with UBS. final that And Yes. will question from come Navin

Navin Jacob

Hi, question. much thanks for so taking my

the XXX adjuvant CheckMate lung on in study. Just

I think first of the expected half PCR the in is XXXX. endpoint

I your think wanted that you us it could just And if recently And We lung study added relates as just Opdivo plus please. if reads learn chemo still half time wondering arm plus from the we adjuvant arm. clarify the to study. is in line adjuvant you remind addition to to out when XXXX? what first Yervoy Opdivo could long

Samit Hirawat

Sure. I will take on that question.

study. Look chemo nivo-ipi you plus thank are that versus that So nivo being the the certainly are investigated three arms versus that. chemo for in

have for such which and study and As the time, you study utilizing certainly is are early regulatory terms discuss authorities that versus in also there that lung terms but we need this utilize take a CheckMate other cancer. observation we perspective know future able to data to in endpoint, the that separate Adjuvant adjuvant continue is as stage and from will with looking be then a XXX how the at PCR in will we decisions. nivo we is something setting forward a then studies to of at making data how health that of that

for XXXX we and adjuvant our from to would terms So we'll as continue the to as think the that this XXX be data does of go communication the looking at in I time trial at in you only well. data forward PCR become available for focus

Giovanni Caforio

Thank everyone. and you, thanks, Samit,

let Celgene for closing, ability close We to priorities, is acquisition strong in execute another pipeline this our exciting just time me we Squibb. the an on delivered integration. commercial reiterate for our plan to advance quarter demonstrating So, Bristol-Myers while work and

ahead of future prevail opportunities in participating the day. the have Thanks and the excited help about everyone promise patients we even us good to diseases. have of call and more for serious I'm over a our

Operator

all your today's conclude does participation. That conference. for Thank you

disconnect. now may You