BMY - Earnings call transcript Q1 2019 | Bristol-Myers Squibb Company

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Operator

Good day, and welcome to the Bristol-Myers Squibb 2019 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 Elicker

good discuss and our and the for Sandy, to call first you morning thanks everybody, joining Thank quarter earnings. morning Charlie Financial this Chief Tom Lynch, Chief me is Scientific our and Caforio, With Officer. Chief Chairman Commercial Executive Officer; Officer; Chris Bancroft, Officer; Chief our our Boerner, our Giovanni and have will prepared and Charlie and and Chris are Tom Giovanni remarks available for Q&A.

language. Harbor Safe the First,

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

Giovanni Caforio

acquisition in everyone. and progress I business the the Celgene. Thank focus you you on morning we performance execution team's of quarter of first John, proud drive have and speak I'm pending quarter with to our our strong pleased and the good am forward. today about our in made to very our

growth brief Eliquis. and discussion highlights some with franchises from me Let quarter the a of and key Opdivo our start

delivered the quarter by execution across a continues perform quarter strong were to driven portfolio. Our results well. solid this and commercial Opdivo

in competitive a As recognize into are future, we space. very the working we we look

of and we continue the franchise Opdivo program. depth to as see growth clinical our breadth a given However,

new going in driven forward Given the Opdivo of indications growth by will indications the rapid over update be I-O of time. new

think I opportunities growth areas. about three in our Specifically,

beginning gone to seen in nearly from where First opportunity have adjuvant the already in is adjuvant out in treatment potential read a program melanoma rates where XX% to XXXX. robust XX%. We've we have the

The second this and is tumors, significant and setting area next importantly, summer readouts is the into of a in including gastric upcoming to a XLA. metastatic of to across range opportunity best-in-class cancers. drive and renal lung the in cell readouts continues Eliquis strong the in beginning cancer And area execution year with third non-small growth profile. near-term

the studies. reinforced of profile datasets by We and be new are strength that continues to encouraged numerous Eliquis additional the

with For for a demonstrating not in well example, antagonists in during safety the population quarter with ACC both atrial Journal published at ACS fibrillation high patients the presented The clarity favorable of which England and/or New Medicine, study versus Eliquis offers vitamin AUGUSTUS of of PCI. study understood. results idea treatment unmet a was patient K the medical the needs for and strategy is and

more We Charlie operating to detail. and the growth discuss that will will are be in strong Eliquis details of a forward. P&L franchise confident performance continue going

to Celgene. of now Turning our acquisition

Our entire transaction. about team is the enthusiastic

diversified company for creating a that more creation. We poised are value and stronger growth is

science to my positions from we've fact By The to And combined that growth loss and do that Eliquis right We've establishing eventually these for of we cycles with day product continue in the beginning this step our ensure development of actions growth. been robust Celgene, the XXXX well us taken pipeline to is Opdivo are very important. have why and evolving, conscious Eliquis combining is exclusivity, Opdivo We're me will on company face in a one. XXXX. future and perspective back long. always company. as Let for this provide successful in the products industry, drivers

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the Our by achieved Celgene confidence this enhanced milestones transaction the in by quarter. was

priority the First, review. granted FDA fedratinib and for accepted NDA Celgene's

to both the submitted In addition, luspatercept and review. for FDA ozanimod were

dismissal three have The Celgene Alvogen provided our patent Revlimid important also challenges further the patent key saw around developments of IP. support with combined and conviction regarding are security in for and settlement Revlimid. clarity our consistent milestones with office's We two the U.S. transaction. due These patent estate diligence with the

growth every our by to stay future ahead Revlimid. our is strengthens Now management programs, cycle our opportunities. and combined curve transaction erosion the This product six will XXXX, life growth let This the briefly post-acquisition. me Bristol-Myers have year Celgene's position. touch of us long-term on company Squibb's potential portfolio, fueled despite expected allows launch current strong to and be of through sales foundational and outlook The products, our earnings

more focus. decade, earlier second cycle its our the to potential marketed to our within in Looking be next half portfolio areas of the diverse and life the has of

pipeline of Our next set will giving registrational the early us matured opportunities. have

homeostasis. innovation balance sheet technology in and cell expanded continued to as with a invest have expect We complementary and flexibility such platforms, to capabilities valuable and strong therapy protein

successful the required regulatory to XXXX. I working in and of remain track quarter a are third transaction, importance fully and recognize work required integration. the We for the approvals the close we on for securing on

this and of outcome. executive importance Charlie's lead metrics success, are reflect compensation We right accountability putting resources building place in the including process, we for with to integration. senior plan to the in appointment as for And manage are adjusted management the this

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Charlie. We I'll are value that, Squibb, the and exciting new chapter it shareholders. create we our to And over at as beginning significant of patients for an work with Bristol-Myers to hand for

Charlie Bancroft

Thanks Giovanni. Good everyone. morning

strong said, company by As is Giovanni this our brands. growth across for highlighted quarter prioritized continued portfolio of the another

Opdivo. with Let's start

good to compared During the up last XX% we growth saw quarter, year.

and seeing forward. going business discuss in today to play in Let the the me dynamics take a we're few minutes what

Firstly, with the and in erode execute and with the remains IA the as in commercial lung, the Within well, lung continues leading team data expected adoption describing, lung second-line leading decline, next first-line to XLA lung in slower to also cancer. within see with be this respect approval. been Part our we've Opdivo and important to coming expect by the looking have agent and line is will though we in forward XXX summer segment, opportunity of CheckMate of And this to reimbursement Internationally, second-line U.S. year. With also we PD-X being size we declining several X size due this in our readouts Part gated CheckMate first-line the continuing population I-O to share expectations. I-O-eligible Opdivo commanding

encouraging plan cell, markets early CheckMate seen new as Secondly, our for reimbursement next combinations, above with to year. Internationally, secure in doing XX% in likely are we forward we're mode competition the see early to to Germany first-line from for renal combination with during well combo continue such as quarter. we seeing we've in and share Opdivo TKI from business continue we access launch already Japan. U.S. And the increasing also we as data looking XER for place and signs

adoption In well the Germany. with to in with with be greater we we drive maintain recent alone similar leading in setting, execution first-line key leading more commercial and to share the share than is we U.S. shares XX% metastatic also or U.S. deliver very strong in indications. Yervoy segment respect in Thirdly, adjuvant this to to XX% outside initial combination In performance. very despite strong we early markets U.S., renal, In by the with and competition summary, positioned the globally And to Opdivo encouraged melanoma, continue continue treatment are we melanoma. continue the than and in reimbursement

recognize the also We renal continue second-line lung will that dynamics and out. in to first-line play

term. and other to tumors, to on based expect growth view potential brand and has as we XXXX However, that the a setting, Opdivo adjuvant see growth brand especially, mentioned, of breadth registrational Opdivo longer in we lung, Giovanni the continue a across in readouts we as as continue

factor delivered XX% Eliquis total to Moving Eliquis deliver exited with now scripts patients as Compared performance. XX% the a from commercial demand prior of to QX, also and and benefited In lower an the to sales year, hole. a With This in liability reported XX% in increased from the we as affected coverage important gap later enter accrue this increases patients be gap since since of for U.S., to year versus used early which for total liability share leading exceptional year. coverage donut this XX% fewer growth continues anticoagulants progresses. to will liability treat of the AF VTE. the XXXX almost oral the perspective year quarter the prescriptions Eliquis, from

$XXX roughly not Eliquis Eliquis world in coverage impact million. countries now Australia. OAC gap one the around in the the Germany, XXXX many was is U.S., year Canada, and just for For reference, the number but also for full including

we by As share be the expansion the warfarin our with in the the expand see NOAC disproportionate undiagnosed. patients for opportunity are Therefore, taking broadly longer untreated to best-in-class to growth supported expense opportunities well-controlled either continues ahead very to or we for serving further Eliquis those to data, see that looking profile term, Eliquis clinical conversion. And not see continue the on continue we of forward, strong warfarin of Eliquis. real-world more a class or of a of use by scope are at

to be in Mix margin the quarter, the Let and saw with gross growth primarily P&L, strong our a margin. during a driver key unfavorability of due to our items Eliquis. non-GAAP few we of starting to me turn now continues

to quarter level Additionally, margin gross favorability during tax that drove we U.S. due negatively and rate tax tax saw Rico impacted our a the our in higher credit. Puerto excise the dissociated of

gross item been line the guidance for our have tax that note adjusted accordingly. both full and for year margin You'll rate

increased in phased behind the full XXXX Turning a change our OpEx than the impacted one-time was we several expected pharmacy. to R&D quarter, investment the for true-up project during to SG&A evenly more and no years. as by OpEx items other such expenses to the OpEx, year, With were in portfolio due for

been well as past, this other royalties, and of have income, billion of in as changes Celgene by years. diabetes cash Erbitux our sheet, many expiry as the allocation. substantial our to affected in balance the described pension that income reductions topics I'll with with increased projected of than combined the starting for potential the flow, related of $XX discussions, be I've recent cash royalties, some to We the acquisition now expense As first interest and three will year more generation royalty. company and in in cash the view in capital free flow PD-X turn having

to Our dividend. years, forward paying increase improving we include our over expect metrics, few deployment our priorities continue for capital credit the debt moving down rapidly and next to

will additional in plan closing development, to we an ASR for billion earlier have the deals. our balance repurchases, we've continue to $X execute plan will Regarding upon we smaller and is look announced, with business the respect share acquisition. as approximately capacity we already And sheet for delay. to Once to the reset, at near-term,

and each to functions Celgene protecting already focused on value our integration Because are base, integrating lean immediately in midsized with business deal each large announcement two as we on can Turning the we focused companies and combining limited successfully largely the company. Giovanni other company teams integrating were than past. soon very drivers core planning. are after and overlapping are manufacturing protecting on networks, employee acquisitions leads plans and a geographies, more integration, be for combined identified of has Integration outlined, the working the

nature and we functions to believe minimize complementary of the key With our we can distractions. businesses, ring-fence teams

tumors commercial research for For in example and mass solid with our being minimize and focus in and Celgene's to hematology, we disruption critical expect in being each function the in company. maintain oncology

scientific lot Diego, hub maintain plan manufacturing San Jersey strategic three manufacturing companies and and that we've there scientific to is we we geographies; are a therapy includes California presence development a that Seattle, of important the good development the Greater hub very homeostasis; two a Celgene Summit, commercialization. to Additionally, cell area Washington work start. ahead U.S. as in therapy including including Accordingly, New as announced protein off and integrate a research which we commercial believe and capabilities; though cell a to

non-GAAP the forma Turning finally to pro P&L.

growth we XXXX growth and As offset through Giovanni in-line combined products the discussed, we decline of of of and expected beginning believe in that the company pipeline drive From the XXXX. Revlimid our realize with cost continued annual stock-based to will at a and perspective, the XX% XXXX to compensation respect the include in will expect non-GAAP we and earnings end end of XXXX. expense synergies; XXX% by of

discipline XXXX. continued the income in annual To we've conclude, robust commercial margin including We growth cost growth expect synergies future will through and expansion strong that execution. delivered drive with quarter and net revenue continued and a

a to successfully even with Post-close, poised be integrating Looking growth are outlook. on believe forward are delivering we an and own business company we we significant stronger Celgene. focused our

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

John Elicker

Sandy think ready to Thanks we're to go I And Charlie. questions.

Operator

you. [Operator from the Instructions] Meacham take at We'll Geoff Thank question first Barclays.

Geoff Meacham

I facility and perhaps you much the in you're Charlie us to but dig into lung the what what Thanks on of just to to you also with from the cadence first-line cost guys and little wanted a offset shift kind the maybe in reimbursement There's view give the to a And comments respect Luspatercept I launches comfort of as wanted question. a the integration think a that of also a Ozanimod then bit synergy. maybe commentary that need from two, reimbursement synergies that I perspective, adoption. or of to you bit that means on on were rollout little a to an it investments about second-line give just And reimbursement and so you. just made color the Opdivo maybe seeing Maybe on. side. coming a just investments mentioned you as access guys first-line much due you ask the to there's the lot hurdles. not Celgene of us make more as for Thank the a what work -- there to just some level take

Charlie Bancroft

Yes.

I start value maybe and your Geoff regarding on can just protection. synergy comments So,

can potential protect on we're focused making in mentioned we're And we not value have the done those of different launches you launches. job of and comments, of really focused from distract I brands. a anything upcoming than an investment drive we've from both As on the drivers that and the my good very both standpoint, I focusing BMS Celgene, would and Celgene organization and sure on don't companies, we But value very ring-fence on a stand-alone where I think basis. done think much would what see

Chris Boerner

and try the Chris, I'll of So second-line. and this second regarding dynamics first-line part is take the Geoff the on question implications your to

as the will the been expected a in on what the bit the quicker second-line U.S. an launch U.S. continuing as of In pull continue expected we agents first-line in I-O impact the So a than outside we seen of to the decline of have to see you have the in the I-O-eligible of size second-line. setting that's

XX%. for eligible pretty patients second-line in one-third is line our in for use size U.S. So, see chemo-experienced the on expectations thus again the that's and continuing having we have of would are And in of example, of I-O therapies with Today the patients what eligible an first-line pull line today be in I-O second-line impact much About and been. in that the of I-O therapy. and in U.S. first-line the those importantly with get because thus quickly how then expectations. Outside agents for the U.S. agents timing of drive reimbursement the access of I-O and continued therapy that are for translate second-line into who bit that's a going eligible the of U.S. slower to large of pool patients I-O and outside we've utilization fairly seen about be approvals

John Elicker

can question to the next go Sandy, we please?

Operator

at Next question JPMorgan. comes Schott Chris from

Chris Schott

Great. Thanks much. very

for about? adjuvant point growth the Final those remaining larger be consider back there about this shaping how Thanks Just that much. are the in to here. what part a And just you're stoppage? of should At And first RCC just maybe questions couple on is is about most opportunities thinking on earlier PD-X/TKI the some about the RCC more push up Giovanni thinking Opdivo. the are combinations. you're allow we question a Maybe of versus interims we landscape lines the and of on those there? an comments. Was any And color the was that time focused -- Opdivo come that bit Yervoy as questions to market the XER, here on competitive excited the of could or relative set second to out metastatic Opdivo, readouts? did adjuvants ones very question the initial

Giovanni Caforio

why you don't start? Chris

Chris Boerner

So let me start, Chris.

continue first-line quarter early renal feedback Yervoy cell we the ex a the very to a still And negative. has the been over as result both In just first we strong share U.S. very to U.S. of in see That's So while XX%. days, early good. mainly Opdivo, in the PD-LX in business growth U.S. in the grew

preparing on outside the this expect share where we've With from respect As I Canada rapid come like is obtained France in early early been mentioned and Australia over of of we key look I-O/TKI And since very and its uptake in European the year. XX%. Germany markets has the in for year. U.K., very good. competition, to access markets Japan last the but We've other days feedback seen launch we've interestingly been U.S. launch to actually later

that undoubtedly important is setting combination study. There's why on in that first-line we we that's repeatedly, pressure going an XER put have As combination some certainly we Opdivo+Yervoy. interest our will this And the and the I-O/TKI believe in said to role. have

believe care that of the responses standard be depth in with + result cell see, is the setting and to that Opdivo+Yervoy are is a renal we However, the we Opdivo low-dose a what importantly customers and of profile durability of going we've first-line hearing safety continue that and from to quality of responses as the we seen of and also life those Yervoy.

Inlyta Keytruda one-third thing data. populations, need patients unpack very more really The the hearing in do the study about were About can't patients. compare that different from Inlyta is and has talking as you about We're customers to directly. we're the data this really other we and of out favorable so of that Keytruda come

that are of of Keytruda the extent About responses of in percentage the follow-up the to of those to we've responses twice and benefit with about Keytruda that compare complete and number we the you CheckMate-XXX know data the has -- XX% of plus for very the the plus Inlyta. durable. continue extended CR yet If Opdivo+Yervoy relative seen CheckMate-XXX getting patients durability a simply to don't Inlyta

context, So commercial and and space. I continuing data to continue in to ability benefit space the very compete our is of the team's complete in our appropriately long-term much confidence standpoint, from value put have to in emphasize to the focus a Opdivo+Yervoy that in

Tom Lynch

Chris two adjuvant. one you. -- questions your And one and XER address on on And to then thank Chris

a us secondary XXX. study. the This gives bit actually looking time is had remains reasons we at This data that XXX to read So study. accrual the as our cabo felt out at more XXXX. that of to little optionality out study remember randomized it fact slight the early to in plus from -- for PFS sunitinib a terms this about looking the important trial we with survival to potential and But a are I increased -- couple We've that and setting Japan XER some endpoint we push primary accrual. The that about was things endpoint. the of lines accrue of patients in versus in Asia overall of expect in nivo about

to look early in seeing of XXXX. we the So that part forward data

coming one extremely the really that think I adjuvant think with made believe in Herceptin. And a back. drugs can you're in we and disease cancer I have is you've is that's important for metastatic when adjuvant from When I-O the while in impact that thinking of points we prevent occur that put breakthroughs the point that real and made I you with important. opportunity think general, consistently true think have fact disease many you

melanoma true with clearly Opdivo demonstrated that with that's in in And think I think adjuvant setting. it's the space chemotherapy. I

esophageal, over So important as the next the melanoma, a renal, say, neoadjuvant I'm trials we you nine of adjuvant and two reading trials you in I three say always one hepatoma, about. them. six that of things be hesitant out which most will study know tumor about in years lung. excited or have to types; couple bladder, will are

first Opdivo that alone. The to we've compared improved has melanoma, Opdivo seen Yervoy and is in outcome

in at And personally the this So interested does important in so we read seeing, melanoma think setting? I setting. will which into the be translate difference will out believe am in to in a trial, I that adjuvant look XXXX,

no Yervoy is I think the therapy in cell in made a medical need. second This place, really important renal big adjuvant carcinoma. unmet in difference Opdivo, There cell. obviously, proven carcinoma. an has cell is remains renal renal

-- see be of that. medical I'll final non-muscle forward area bladder Again think bladder muscle-invasive is going out difference. then Looking call I-O where an need area make invasive unmet important to a I And to an the one cancer. will

John Elicker

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

Operator

The BMO Markets. from Arfaei next question at Alex comes Capital

Alex Arfaei

for couple have any first expected tamper of give specifically reason amount product. congratulations big have as your higher provided one merger. for trials the someone trial, crossover assets shareholder Is on for our their II. CheckMate-XXX merger. And the you. Celgene any from sounded your given investors expectations for or by competitors. -- please? support should their other Next trial and Can this -- information expectations five A there puzzling your for on the you you variable? both the your Frankly have little we about which such thinking is Part thank franchise you latest a this and us Great, there winning I-O cautious

have could big of you if including estimated you expectations your in, estimates just five You products by by made speak them one they And provided aggregate agree an latest on six give could indication? whether more as with have TYKX. sales Opdivo please us the I Can of their comment product? for out you. for assets your Celgene's you Thank

Giovanni Caforio

Thank you, is This Giovanni. Alex.

ask just two sales an let So by Chris give to on questions then answer I'll update the and -- indication. me ask first you Opdivo

extensively So There no in very mentioned the the in readouts, Celgene, with look we update really are there in aggregate. summer. data as and few expect wanted -XXX we perspective. the estimate to to discussing is respect to were you there communicated no the of our II sales the in assumptions peak incremental readouts we disclosure seeing remarks, forward of six as we've really last value the the we months, data. we risk respect provide pipeline. to important we've With believe provided Obviously that as know, financials, what and our we an you from our but Obviously said Ia and for news we that five launches in included launches adjusted as as

or we we company after transaction. may assets the guidance, for individual the combined to future relates about we'll provide close it As talk that

Chris Boerner

given is in bigger the me I'd just XX%; In just business. other are XX%; about Let lung is dynamics indications. of of allocation hit outside about reflects melanoma the make percentage timing U.S. over about lung being XX% the just second-line is lung that is and of indications renal a about is XX% as comment and well. only XX%; all on U.S. just the The the of

John Elicker

to can Sandy please. question go we Alex. next Thanks,

Operator

question Research. Anderson comes at Tim Wolfe next The from

Tim Anderson

couple of Thank questions. A you.

level. a is one kind of First higher

analysts, free biggest least. your you on are has been are you What your opinion in the for hear first the of think last do based this and concern In That's stock at fall that your happening? few why is that misplaced? investors about the So think areas with conversations question. and weeks you

Second question has hundred fairly OPDIVO Part several large arm it. to actually get tucked It's patients. of That overlooked. -XXX tends X it within is a monotherapy

failure think the seems -XXX itself there following back it's still It's around but product monotherapy in to as lung the August. like for could not of in I registrational, be chance a spectacular XXX. front-line it redeem

So are this and odds not I'm you arm competitive it's we registrational. high guessing you'd the see fairly that from say Can results good often-forgotten-about comment? recognizing

Giovanni Caforio

Yes, Tim.

to ask you first address Tom -- his me your the let perspective second one. Let give I'll ask me and question on

So with as all respect interact with imagine, continuing obviously you are interaction with to our can we to of shareholders. shareholders,

We value of in the that we opportunity deliver are strong long the are shareholders for believers term. company the to significant in and the creating value

is right really making our focus integration the So we and value sure that that combination. deliver the successful the is full on now of

I think focus And a in a discussed progress can difference where that's that's now. we making think already. we're as I big make as remarks great right where team we've is our and

Tom Lynch

X of I group going overall which status. in some cell will reasons. of think will be we've And Tim PD-LX summer thank multiple out; terms put you'll you and we're -XXX be question the by coming patients lung for survival reading to in Part lung cancer. be Part of all said for what perspective this seeing important totality that of selected your is a which And want And to in along results on non-small that sort cancer. lung I out cancer doing the just of be we Xa to have different approaches data and

interplay in in still remains very response of question. understand sense to think the get a driving give I because a look understand trying the data You're us biomarkers this of to TMB in monotherapy will as important to interaction also better it it saying the at I-O, correct be the the arm, well of what's to overall will allow but from able us a

also chemotherapy response in XXXX. in XLA, out the be think looking which then reading which Again, we I setting. will we'll to see also cycles of to results has potential -- of we're two that to durability combo a followed establish upfront Part by of to Now OPDIVO/YERVOY, that want also for expect summer, is draw we the chemo your and this X our which attention

this setting. data. So I in very you at performs look that the of it'll interesting forward to that think to readouts important And how a number lung of seeing We cancer. see monotherapy point all be out absolutely

Chris Boerner

now expression. the other only use that greater vast entirely XX% in to outside majority to to thing chemo of right dominated catered business has of combo. be than setting comment the to The tends the PD-LX of is evolve the and monotherapy the monotherapy I almost first-line in would begun that a setting That's

John Elicker

we to can Sandy, Tim. go please. next question Thanks,

Operator

question Fernandez at comes Guggenheim. from Seamus next The

Seamus Fernandez

Great. question. for Thanks the

like So endpoint some Asian been likely you progression-free triangulate would of pushed in markets. the study that I'm XXXX Tom, to around at that sooner same or here. just because kind study have would mentioned trying primary understand the of It just out the -XER least has a study PFS and but time. seem the survival, at/or to couple finished that the is recruiting better.

data to the from areas physicians label the is to bringing I'm trying why would competitive event-driven most just so at all your get you be I'm guys And kind and PFS Thanks. of overall have thoughts heading in learn pushed that of survival you study. alter in out understanding an second Obviously, landscape what to trying plan us get of get on update the that discussions just endpoint if of -- year. at understood patients to primary just study we of you're of going and might the sense rule? better Asian So understanding part an this Bristol ensure question focus have positioned the into about as the ASCO stopping you Merck's present the your did of analysis statistical can that how is this get we on as ASCO. just the a then there? the better you're us with I'm it adding a you maybe approval then trying of to

Tom Lynch

Seamus, thank you.

So dramatic market number sufficient push-out And the it and slight have push no to the been us to a important. plan. to the in to give important in needs is sample me It's statistical important this the well. is, of impact patients the on we and -XER reiterate we a and setting day. be data. survival the able size And it's reach change going of that's think our there's let secondary it's just Japanese of to more for second increased which to not study overall to key endpoint, just felt of Japan address we around that optionality global readout as out and accrue was One global be then a

in plan believe no well that in we to and positioned determine answer question Cabo the to the change the do So setting. be statistical important OPDIVO there's and of we us will role been that help

time readouts on regarding for we've ASCO couple number be our such X it a summer ASCO Now and X. a year, this said available of this as of actually Part happening times important as this and in Part won't really are call,

those we at hope Now of update year. will our available even be many and this ESMO head neck data that including potentially an of

we're group proud a that that able by data which group in from year, really are had a TMB of cut-off refractory Again, ASCO high benefit TMB the OPDIVO/YERVOY of we're we actually think is productivity had of and patients we was year a the our for reported and who previously some setting look lung that in group with this this GU. than patients of think on group very cancer. at data find that AACR, to patients TMB. in the showed some different that the used that patients treated activity cancer, lung this Also was GU in of benefited presented at that a I patients translational long-term we ASCO, OPDIVO/YERVOY a cancer fact of at hormone with defined I important seeing of medicine prostate example with at the of good particularly

PD-LX four-year cancer, a you're positive, survival setting. second-line that is truly lung remarkable in a which in If XX%

readouts So to will good data upon a depending the be of see think again important I larger study ESMO timing place be and some of lot there'll data. a of

John Elicker

Thanks, can Seamus. next Sandy, question we to go please.

Operator

next The Blair. comes question Matt Phipps at William from

Matt Phipps

taking for my thanks Hi, question.

But row a the share given Or Keytruda U.S. I sales Or there that decrease risk? Is acceleration RCC is in the sales per So now decrease intermediate year? secondly, of of that looks that guess second patient OPDIVO, with believe. right poor quarter with in dynamics. in schedule, quarter-over-quarter XX% will in for -- U.S. in mentioned continue? it slight approval unexpected first-line the then second-line patients? think you the ahead across first-line you is first-line that half in this a like do the label is slight chance And on population RCC second market all lung I of a in not

Chris Boerner

for question. Thanks the

growth. just me OPDIVO address let So

if lung First, you of story cancer. in quarter. across quarter outside just a put for We tumors strength really all of the good the OPDIVO context it our very saw was

still adjuvant And outside leading cancer tumors well a sales promoted of all quarter-over-quarter business of we as to I that We function in melanoma. as grew the continuing that's expected really in renal all tumors. lung growth base cell we're as fact, and be cell seeing have first-line mentioned, estimate in shares our non-small strong. of as In

overall, quarter So much cancer. we our majority on see to really very The strength were good lung businesses. very saw the headwinds focused continue of first across you that the in

As in pool expectations, does see the in line setting expected, That's very of eligible decrease with but the in the to pressure second-line we growth. to continue referenced impact due previously. the I quarter-over-quarter patients much

are thing saw OPDIVO going saw this running move second monotherapy year. the about range continue we continue was the the to going in remainder the first we year-over-year, I quarter And you that remainder to it's of had I XXXX. quarter and but X% as half the see and been remainder quarter of come the the expect, that to X% first we foremost we in that first globally growing as that sales think of likely forward for in about we forward saw to X% to latter first-line in We year. the I in down flash the in decrease stay The a the think through would year, dynamics setting. that of Opdivo That the nonpromoted to saw

the with in share We the population, the vast renal of risk in the scheme that in see X% share is intermediate but addressing about majority favorable and That of Just is things. poor XX% the label. our do question consistent the small grand in population. cell that's relatively

John Elicker

go question Sandy, can Matt. next we to Thanks, please. the

Operator

from comes question next Divan Vamil Credit at Suisse. The

Vamil Divan

much taking Great. question. Thanks my so for

and around just international a really pricing for B. So reform reference this specific of drug Part to around question sort one just of pricing concept dynamics

much think maybe that that and in reality, but first becoming think growing I wouldn't like when if feels that reality. don't a was become credit our sense may a for I it maybe investors too a get actually conversation that proposed actually analysts that there's

you But So you Thanks. the and question guess data is impact Bristol coming at little any mono-therapy B does the point? later the expected uptake overall. pricing reference – stronger Part given data just that made. in second what to way Xa know displaces these some Merck a you already combination in might for that I'm Part just of And So need cell? expectations show just then that seeing in of you and even the comments trials. timing of with Opdivo if given terms bar sort and I following-up of specifically and show degree is X if wondering, through bit that just than to the frontline my and on non-small had how the therapies raise event-driven Yervoy I international being can have share is on can't your control Part implemented wondering, on the you

Giovanni Caforio

Vamil. Thanks, is This Giovanni.

start the just with about pricing. question me Let

as the first to a entering which discussion and an to time, continue. and perspective period have be that in, that things do to and the are at one with across the the the may that, times, continue number to to I believe larger me I've So pressure broadening all, is accelerate pipeline will the personally portfolio demonstrate and growth spans focus presence of on and a about let And us reimbursement expect value pricing many of important fact, you pricing and I will company continue of adding think evolution in remember, for said having as over that we drivers the segments. doing my say that assets that in will of be I payers company the feel from access a for we strengthening it more diversifying U.S. I multiple the really payer believe

It that the correctly. patients countries in being Opdivo where almost as are increasingly included payer competitive will things a in in is you are in to company innovation completed. an yet. perspective, when position the now in and are don't idea remember all of in in of that think not with IPI included is it's standard better is you at respect approval I access a half look not know market supportive think a which many a after having that Because U.S. metastatic at when should With I we from BMS Celgene are happening care as approved of that basket be international transaction the in of these broader expecting, reimbursed as to really – Yervoy not with if what proposal. that's regimen is the Europe transformational was think we XXXX, and they a And of therapies, in look I think melanoma reference new the you we basket, that's referencing the what I really much good markets the

that many the I approved years indication melanoma the markets in in for think of yet. reference the last the in few the included of adjuvant are the almost last same approved those where are is And not reimbursed are half that's not basket true oncology that year markets. products reimbursed

administration address proponents IPI way the for that's of that in probability not handicap some me a to clearly, access, goals reinforce that and but can tell It's in So as policies that stakeholders a way supportive out-of-pocket has an the patients, to and out-of-pocket we for forward. of the but policies exposures does. work to in you what of innovation. to proposal difficult reward And are enable we What and are innovation. proposal to I that a affordability the together is exposure are continues issues patients rewards continue like that with of truly achieve that discussions industry that radical moving in for we of and

Chris Boerner

There line frame being It currently is And which the just an the readout needing half me What entering think mentioned this through on in I we Part consideration. therapy. launching. comment in chemo compete which to quickly would know sparing I still would Physicians don't seeing Let first-line what of into that, from very we from does though competitive addressed we're earlier, to potentially as well us would is only for just Merck how and lung of over I a hazard that particular important They're is still space. treat say a cancer be think room obviously context first-line looking I-O patients different I opportunities and is to looking we timing forward data about to readout. the vis-à-vis front-line multiple of Undoubtedly, data play, opportunity. large this looking space to this terms standpoint is are to ratio. about we relevant options, Xa. hit this options know a for competitive say is opportunity.

John Elicker

Vamil. Thanks, please, Sandy? next question Can go the we to

Operator

The next question comes from at Scala Cowen. Steve

Steve Scala

are There Opdivo readouts can of on a you. a due already the delays. Chris the in the paint a to eyes a Can good KOLs you XXXX. secondly reasons first-line both sides. identified. obviously Lynch, OS said lingering is ongoing was And Thank so was was maybe of out that Or times KEYNOTE-XXX in KEYNOTE-XXX And be quarter. questions the your could win? point range the of couple plus some which Previously all summer. if CheckMate expectations, possible uncertainties that delays, the beyond year? are for fans data Thank of the over can not which Dr. be Yervoy point you. second clear It the in you then this course from you were prior wondering of arena. data are appears reasons -XXX There what expected now at I'm data one push approaching a provide out late and

Tom Lynch

Steve, thank you.

the lung point, first regarding readouts. First on the

people trials. down because is accrued studies, things. event not well, really of too the down way they event-driven and arms. events the One rates. happen are can think when events Just going read to Because the these into it's of they're a event things or slow slow can really much and couple were just large different rates are because to happen And the I important

event don't I rates, data the the see this the are. anything summertime We'll I event what respect. that read are So rates into in they and think

that that Opdivo what about at a the what maybe the now thing setting. unknown we to I point. looking carcinoma regimen have renal that think that a looking important like and the again, provided on or comparing is regimen cell at want bit that at that's is still you're And you're when a Yervoy TKI really we at of with of say, I something fine, is of think and duration follow-up this I but is, looking a and and again, it's excellence sense have response combination benefit duration with that's that's Keytruda in unknown

we TKI we'll duration of That's as although, that that unknown comparing data plus the PD-X believe have one that we could see with But be important. obviously still out have evolves. benefit you're how studied why we XER. So to also pointed strong very

John Elicker

can we to question, Sandy, next the Steve. Thanks, please. go

Operator

America Lynch. at The next of question comes from Jason Merrill Gerberry Bank

Jason Gerberry

I-O/I-O intermediate? think think I-O about the thanks approving an evolving it's standard you will about treatment the to Is And remain of I-O/I-O? that you Good comment second I on Thanks. so poor then behind wanted morning more evolve questions. lack or the and just market renal a either second-line my your the vice remaining for I by renal. to options up of in Opdivo shared between follow care therapy? Or option I-O/TKI do followed I-O/TKI that – and market guess to in second-line as field would much dominant taking the do versa thought in of given this we think

Chris Boerner

initial be that think TKI are Yeah. care multiple think favorable YERVOY in coming is dynamics. in be the What Both much where to to patients. a I is the is to see be option patients. option going to indicated. the and OPDIVO to setting then certain for think a in to will questions likely best of the plus going turn use very good extent an out say not in would play will with second-line first-line about, would choices standard patients, very plus the But are dynamics are of one that that answer continuing respect you're suspect going make I which months. have front-line impact likely marketplace That I I that, I-O the modalities for over be I their the these to we of will physicians it

increasing now see in in to about second-line pointing of You're correct therapy renal the OPDIVO plus out to uptake use use an for the begun continue in combination the that second-line second-line setting. see the We've you space. cell. in in XX% of example, YERVOY, It's might

they if thinking vice to I to to data start in play going think, in with and first-line, those potentially combination so, TKI you're evolve. out going and about need through to a And as plus versa. stay use physicians to the on see OPDIVO the we'll to in Those dynamics YERVOY connected continue months continue second-line think are coming obviously

John Elicker

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

Operator

The next question comes from UBS. Jacob at Navin

Navin Jacob

ex-U.S. which over the do may, first-line $X appreciated. to CheckMate $X we think interesting. billion? color have XXX Is for a XX%? How a opportunity, to for of that it about Maybe few kind trial us XXXX. upcoming Bristol talking that HCC billion question, dividend of will are question. ratio you size for market? the we maintaining do Hi. market, mostly HCC? be And an next you that Any about the How And roughly that dividend if payout post Thanks one Charlie, -- is had think which Maybe policy bit remind you I little think -- two how a can about think perspective you you that above was Will will Is then, of $X commercial the billion be about the a stand-alone, billion Charlie. ratio we or be? for years? taking I $X the about your two trial, from deal U.S. for close? for

Charlie Bancroft

Hey, Charlie. Navin, is this

your for question. thanks So

dividend. to we will and On the said discussed, that the continue we dividend, increase as we

payout with said specific Bristol. haven't a we said as haven't We ratio,

were point we continue earnings, Our And grow at over our payout to we line, ratio would was as XX%. peers. more say, I with one in our

are going the factors. I a where So how the it our think number the that be time, moment go-forward of nature business, is on a against -- at we of fundamental business in will basis,

we the the we -- policy we immediate have dividend So next once past, for in have like, year a our year. give

Chris Boerner

to today respect is attractive a the use second-line HCC, OPDIVO market. considerable see of obviously with in And HCC space Yes. particularly XX% about We with share.

We use also third-line have share. the good with of setting in upwards XX%

wait to opportunity, we But think, seen And be out. In effective we'll terms the more opportunity that of once and data attractive going to able be an a I-O in see to it's space. the provide the we're data clarity. bit very and I get pan have how we've

John Elicker

can the for questions. time Sandy, go two have we Thanks to think Navin please? I we question next for more.

Operator

Umer Evercore. from comes question at next The Raffat

Umer Raffat

Hi. Thanks questions. our taking so for much

was, exactly specific the U.S. Canada? My question the arm for placebo year. to trial. next territory, inevitably trial lupus how if first. on this us the Can in And on the that I feel know not amorphous you the TYKX And was saw I'm shift the implemented that do you settlement trial. a in just up, how will we for coming next details a Celgene about Dr. have I steroid? Reddy's Thank think First, program, focus Street the form that taper key Reddy taper understand, there's an to of in you. steroid very trial is, on That like with noticed works to give forced more Canadian Revlimid second filed little trying being the

Charlie Bancroft

Yes.

the don't different me if and other. really read across so claim one speak about the patent you know can't There're Reddy's in offhand, I to have so jurisdiction from amorphous frankly, Dr. let So to that. to regimes on the first get quite back filed or you Revlimid. not, Canada had we'll U.S.,

Tom Lynch

And, extremely pointed about. we're is Umer, regarding I TYKX, out, a excited that this you think compound

delighted psoriasis I interferons Phase As data which looks look both the as it forward we the in We see IL-XX/IL-XX Type you X the seeing activity it's as trials mature. that well drug a through to like were we those pathways. has continue to and saw to know,

in X we're also that have bowel appearing. inflammatory that We and think We disease benefit inflammatory lupus, is could bowel beginning in in studies is in study do have disease Phase setting. this which an agent a

difficult a think lupus some in And a defines disease has thing also of one shortcomings very I the disease disease terms year, a lupus heterogeneous in in with disease. what to this mind other what with drives that how saw we It's disease is, It's been. treat. think trials. to the very keep challenging and of I notable

taper so the steroid potential at look TYKX And steroid a the the for have to purpose to of more versus objective benefit is able potential the the be the of the of interaction. benefit for

So inherently number are that variables of present trying variable to it's disease. in really an reduce the

John Elicker

our to please? Umer. Thanks, Sandy, we question can go last

Operator

from The Risinger Stanley. at Morgan David question last comes

David Risinger

Great. Tom Thanks please. for have I questions very much. two

respect trials just as some little expectations? placebo and about XXX talk with specifics Thanks adjuvant important? you your for bit the go timing then XXX could much. through between readouts guys to trial potential of highlighted And you talk you little could most the the very of First, of about second, Part X more a similarities that a and bit differences other on and

Tom Lynch

David, with to thank you things off Part of a couple X. start and

X seeing a don't on positive by hazard what placebo how arm in looking will some which XXX for X. ratios in that we perform way very all-commerce histology an extremely that's then comparing is placebo provide arms is performance Part some I the at arm XXX So that setting. noted our -- I X have guess, -- seeing know to the histology. interesting forward placebo was what we the across difference to our time poor, trials. what ratio we cell. think particularly do driven hazard to of it caution is setting. will nonsquamous in the the is patients arm biggest is I Part issue causes a that a look in as Part and think at that histology. to led benefit Obviously, I can of placebo The

landmark doctors things the about effective always I what many really is think makes think, doctors makes I trial of really the a when at way this is, you look analysis, treatment that to about effective or people treated. of And the like think how relevant. much never what a treated this to and is One a the later. what ask the many Patients are how of patients what four still hazard year with That's years have three progressed and ratio you or alive, given will -- more treatment. not ratio hazard a later be

to I when important keep the at in that's we Part look mind again from at we something when X look So data and XLA. data think the from

of remember, to away. the out the a into cautious time second so event-driven, but you timing These that's X,XXX-person read I specific earlier excited line. are I about think very -- far melanoma putting XXXX. trial going trial. I mentioned to half that And estimates the can be some bit was Remember, about. point. of give you that's readouts, We have think I we're at too Regarding this a pretty much little

trials. trial In hepatoma, could that first of our have quicker. half later. Bladder out -- cell half to XXXX, XXXX. the setting, that readout we take XXX-person in be which event-driven half in the reads XXXX. point. be longer I mentioned, hepatoma our So In second could adjuvant that's Muscle randomized obviously I trial, of Invasive the the that's our a at develop. also of have mentioned second in adjuvant It Cancer, And we Again, the renal And events

because about the scale readouts thinking ask size because exercise the that settings. in caution, in you those So the these what of when trials read terms gives But again, out. we're I and the of you to of of variability in of

Giovanni Caforio

everyone is Tom. and executing Thank the of strong company you. Thank have are Thanks, forward in Squibb. strategy quarter acquisition a focus confident we with driving in the for We've Thanks I'm Celgene. on for and closing, a a the opportunities at the ahead. we've our and we call. you. building time that remarkable to and you, the respect this had business progress really participating everyone. us Thank maintained Bristol-Myers In strong made importantly We've

Operator

This concludes your today's call. participation. Thank you for

disconnect. may You now

Bristol-Myers Squibb (BMY) 25 Apr 192019 Q1 Earnings call transcript