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Bristol-Myers Squibb (BMY)

Participants
John E. Elicker Bristol-Myers Squibb Co.
Giovanni Caforio Bristol-Myers Squibb Co.
Charles A. Bancroft Bristol-Myers Squibb Co.
Thomas J. Lynch, Jr. Bristol-Myers Squibb Co.
Murdo Gordon Bristol-Myers Squibb Co.
Umer Raffat Evercore ISI
Jami Rubin Goldman Sachs & Co. LLC
Andrew S. Baum Citigroup Global Markets Ltd.
Seamus Fernandez Leerink Partners LLC
Tim Anderson Sanford C. Bernstein & Co. LLC
Chris Schott JPMorgan Securities LLC
David R. Risinger Morgan Stanley & Co. LLC
Vamil K. Divan Credit Suisse Securities (NYSE:USA) LLC
Gregg Gilbert Deutsche Bank Securities, Inc.
Geoffrey Meacham Barclays Capital, Inc.
Call transcript
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Operator

Good day and welcome to the Bristol-Myers Squibb 2017 Third 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, Corporate Affairs and Investor Relations. Please go ahead, sir.

John E. Elicker

good and Tracy, you, morning, everybody. Thank joining quarter earnings. for the call third our review to today Thanks With Giovanni me our Bancroft, are Caforio, our Charlie CE; CFO. Charlie remarks. and have Giovanni Both will prepared and Gordon, And well, Q&A. Officer our Tom for Lynch, Chief are then, here our Murdo Commercial as Scientific Chief Officer, of care Harbor language Take first. Safe the

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

Giovanni Caforio

you, John, and good morning, Thank everyone.

to want the I started, a Puerto get Rico. we few words about say in Before situation

significant we ongoing support As very you disaster a efforts people that and know, to this we humanitarian are and relief. our issue, safe is focused on are provide ensuring

commercial plants as as operations manufacturing We well the two on have island.

that to happen, contingency plans, been They've disruption. to do effort a on the I'm priority supply of great colleagues by for despite to With job accounted and make our respect our report XXX% first any our make teams is tremendous sure difficult people were very Our conditions. against a the done pleased our safe. not And have operating hurricanes following to we was ongoing. our executing There's expect operations, island. this effort to we've

as rapidly restored essential infrastructure remains the it possible. forward, is as Going

good Now, another company. I'm continued pleased that and for X%, strong. quarter. Despite had across getting the grew U.S., Eliquis back a delivered a to we We increase. In Opdivo's revenue continued market all of growth high-XXs. we performance across lung oncology, very another with indications we very Globally, by quarter, quarter. the be competition, Opdivo, maintained performance In share double-digit Orencia. XX% good in second our to line strong the increasing Opdivo had the the strong with

strong other strong we We in are U.S., also in in seeing we of move those along launch renal the the performance are good performance, seeing shares tumors, with melanoma. as Outside really and markets. curve

I-O and liver clinical approvals pediatric an Our melanoma in patients. for We continued colorectal for us of FDA our regulatory the cancer. Yervoy gastric to FDA also for Japan and And well Opdivo well expanded the achievements approval cancers, portfolio. growth in as positioned secured indication as both include

new is an cancer, lung important small Yervoy. we're combining rationale validates at forward important data and SITC. and for looking Lung in cell on risk result patients. Our stopped Opdivo in cancer, this given intermediate overall to granted breakthrough We early We priority for cell believe the for survival review poor IDO the to Opdivo that TMB on sBLA announced (XX:XX) from We World presenting which our renal was results at designation. CheckMate-XXX in was adjuvant in presented melanoma and data

potential milestones significantly bring to ahead, to our are a of broader number efforts, immuno-oncology benefits of a with Looking set patients. the expand there of the to

for first-line XXXX. the combination results lung to from in expect in see non-small the CheckMate-XXX cancer cell of the first We final half

pipeline benefit head for year. and Opdivo cancer Eliquis data strong, looking data our on is small combination next delivering have later atrial And I-O We're from patients growth. of XX% Eliquis first-line in agents registrational good and oncology, who performance in approaches, encouraged to further in for to NASH. for build the really within forward to FGFXX the portfolio. I'm our opportunity see where with and We important in IDO real-world tremendous combining growth expanding looking LAG-X. for wave in next our We fibrillation. looking forward this cell at our forward of initiation progress opportunity very Outside additional continued to of AHA. I-O our with reinforcing real-world agents patients studies see are year for also Eliquis and seeing agent I'm to number to role neck with stroke portfolio diversified data was advance, HCC its lung the reducing

there discussions the the for our where to new need is also assets, treatment BTK options. and immunoscience, on We're in program in progressing and in are next we with beginning of in coming our XXXX. early-stage pipeline our important two areas inhibitor our expect in data where deliver the plan promising These an inhibitor FDA medicines TYK-X are proof-of-concept We phase months.

quarter, acquired assets which the science. further our immunity, immuno-oncology. strategic development of During innate build IFM, specifically expands several We in early promising portfolio pursued our we area pipeline, in deals, business to and an

pipeline are positions an capabilities PARP to to delivery of treatments. have in We us cancer for significantly. I have to the also with program agreement time, start a we Clovis a early evolving its inhibitor. pipeline promising had And signed and agreement we with our long enhance most deliver that our development joint believe Halozyme the our

data, investment research, integrated in translational We as approach. strengthened R&D part have real-world tumor a our of and biology our

continue and the position for us As Tom to patients. our regimens detail, we in can more medicines these describe demonstrate value of that believe to capabilities well,

over the floor that, so, And Charlie. I'll to Thank turn with you.

Charles A. Bancroft

with was strong everyone. important quarter for across key This sales company, Good the Giovanni. another Thanks, morning, brands. growth our

a product starting with begin me Let brief of performance with I-O. discussion

delivered we for Giovanni share lung in leading strong U.S. we commercial As second-line in and the performance, as maintained Opdivo mentioned, renal.

lung achieved renal additional robust, Australia. in approvals, reimbursement non-small the cancer we in continued cell drove and UK indications. adoption growth other also International lung We melanoma and including and and was in

forward renal in with we building melanoma our strong on approvals foundation, have potential and adjuvant meaningful cell. believe in opportunities we Looking ahead first-line

market see as somewhat dynamics near-term we For mixed. Yervoy,

pressure due to We regimen renal in first-line use risk Opdivo of potential but adjuvant melanoma, cell. poor for extended in expect of intermediate the some adoption

Our performance strong product saw $X almost the for Eliquis, across commercial also growth by to the was driven in XX% which revenue. the annualized execution bringing exceptional worldwide a portfolio in quarter, billion

in described we year. that headwind the the of the commercial continued during Spain. category compared and past, first and believe seen expansion, considerably on the delivering Germany, we is As Though for this and performance TRx This in Canada execution products and of during of leading growth U.S. the forward. and respectively. quarter, poised meaningful QX this the continuing growth. Japan in one markets important terms very at is brand coverage put as increases delivered growth illustrates Eliquis life to of for quarter, With the across and extend UK X%, is we've impact XX% U.S., demand the portfolio. stage half the good growth the class year-on-year sales Sprycel the U.S. going cycle Orencia for NOAC well-positioned their new-to-brand lead its the the strong in the Eliquis such X% gap and strong with within of QX Globally, in the number underlying the increase reflects in sequential Eliquis NOAC a scripts is and

by to P&L. margin. gross to I'd Turning like non-GAAP our our start discussing

virology. While the in of pressured the with particularly performance declines trends quarter, we the coupled demand and the mix, gross growth are was to pleased by Eliquis, our margin product during due strong

seeing a globally. also We inventory related took the one-time, charge we given to dynamics $XX HCV, are million competitive

we gross continue Going expect margin. respect to be forward, mix the main to driver will With OpEx. of

continue in finding business. ago. across of for rest efficiencies delivering we approach are a while of Because about the key investing been R&D importance R&D a as the on realizing our our to view We our in potential, priority. year long-term investment of the pipeline outlined we We've

executed with capital the adjustments business to respect liability. our Regarding year tax QX, and a and Puerto development the excise in allocation, our credit we rate, remains from for Giovanni several prior was impacted operational the top disruptions tax the a that both during to Briefly Rico hurricane-related island, expected priority, from tax transactions outlined reduction by unfavorably rate key quarter. during tax on

back the additional we for and quarter, to million buy Additionally, plan year. million we $XXX an during $XXX the of stock the bought end of

of for XXXX. to Turning the remainder guidance

advancing in tax of be we execute going by our to Across to our To to the portfolio commercial assets, our important revising and company, of outstanding range. future I'll and tremendous marketed I and due year-to-date outlook are progress to for strong. close, towards made the we XX%, margin back encouraged rate said increasing pipeline to success. Having there Rico, range continued business We across pipeline. been $X.XX. end to performance opportunities it $X.XX the are performance fourth that, John EPS Q&A. has products very Puerto well-positioned deliver are We turn non-GAAP to believe are our quarter, and the into now and gross for mainly the lower we've our expect and are our

John E. Elicker

we're go Murdo and Tom addition as to a both in Charlie. Charlie, Thanks, Tracy, Giovanni reminder, questions. ready I are Go and to here. think to Tracy. ahead, just And

Operator

sir. you, Thank

take now go Evercore. question from Raffat from first our will We ahead. Umer Please

Umer Raffat

burden. taking two-part guys. my had mutation tumor so Hi, question. much for I a on Thanks question

in that to similar the First, just what's I'm intend you of to on trying understand, that base you're CheckMate-XXX? change test was the CheckMate XLA other second, very type not trial, what you confirm done is the much. TMB no been plan, using trial to analysis Thank but in to that CheckMate-XXX? And you trials. perhaps and of there's the primary use can then, statistical that on test

Thomas J. Lynch, Jr.

for interesting about cell I I you about Thank thank to indicates cancer, is and and lung Tom. used you it squamous cancer. what where about learning be is And This much a Umer, more think this When a that was is think your so question. how the TMB it we're disease very just adenocarcinoma. part much think very one lung you.

Now, is saw where very understand fusion in ROSX three lung disease EGFR you biomarker happy we're to have we're RET important that and data sets also important TMB an to and and And increasingly, starting ALK and potential PD-LX it's proteins you cancer. and a present. that

course, small lung similar in data this was data cancer, then, select The monotherapy. cancer, both for at patients select Meetings We first to you group World Yervoy year, which week could biomarker. Opdivo of and as at showed CheckMate-XXX Opdivo and from showed combination benefit monotherapy last and using important could that patients alluded AACR that Yokohama, TMB we Opdivo bladder we that showed an to the in Lung seem that Cancer our a cell data in of therapy, you

look important of to we tumors. studies, in So many wide a for something of variety at think this our us is that's in

is be news panel, there to defined the ACR, – do doing think, appears sequencing very to think use And I the I both be a Now, we whether we excellent of did And set genes. you good is a When with concordance your two a evolving. how showed question XLA as that of did FoundationOne specific it, that, sequencing sequencing the it, between will it you as is we mechanism exome whether how we for assay. set whole about do do at that's a our measure or field for whole and a panel Foundation of plans exome types CheckMate think good this one. CheckMate-XXX, you is about the

area I how but think area the of You result, that's it's a also concordant great important TMB? same important think tumor our one think don't several very becomes as going it based, translational this all be to teams a the of to does think it that's measure are do will their I will evolve interest, each putting over be years, another where next lot get TMB more and serum-based, with I results attention. marker. be Will exact about, an other. is the medicine

want the to Your plan second about I statistical question I to CheckMate-XXX. going be regarding We one And aren't plan. CheckMate-XXX. of is say about stat think the talking really just thing

important, have across at talk we about optionality that, plan you look that the broad going variety great I of to we your of have and continue one tumors. of the to TMB on but endpoints co-primary with quite we're question think today As of PFS a and stat know, CheckMate-XXX. not But is we at enthusiasm, and looking OS,

John E. Elicker

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

Operator

Please We question go will next Goldman Rubin take Sachs. Jami now from our from ahead.

Jami Rubin

you. Thank

Just if on follow-up Opdivo. can I

happened – I CheckMate-XXX, and possibility? in would already analysis you think has will Giovanni, the final half see whether still interim, fact, an of the then, an or that you interim we during said that be a XXXX. first passed? not the there confirm secondly... And Can Is

John E. Elicker

you. lost we Jami,

Jami Rubin

hear you me? Can

John E. Elicker

go. you There

You're back.

Jami Rubin

Okay.

happened there. know that. I don't about Anyway. Sorry what

As which you used time, have year. are adjuvant will has second-line big the as hopefully a the lung about important, two will we to renal, dynamics trends frontline same in very over in change frontline At KEYTRUDA year, think the next opportunities. melanoma, for start been

So sales think about and can just to help us be just about very us down, you will sort that. Thanks the high-level sort next the to pulls Opdivo of help line, to year? flat, think Bottom franchise up, much. pushes

Giovanni Caforio

Jami, this your Giovanni. Thanks questions. is for

current So to let with perspective for for year, in respect a CheckMate-XXX I'll then, changed. me timing to the that's trends his to the perspective the you really you we've on Murdo on analysis half not give first consistently analysis, interim maybe my give of ask comment, say, just and and final Opdivo. said next Tom

give not do it's this that, are, existing going to perspective It's discuss XXXX point premature We important to but trends. on at specifically. any obviously, to more

Thomas J. Lynch, Jr.

And the Jami, question Giovanni, thanks thanks, for interim. your and about

happen. we interim – what know going that, events you and as don't really to are when the So you know, event-driven. about And can't is said it's you

that's X, events We you'd they but love either on to they frustrating, events, the think be date to will We to be able all and we're have the for that point. early data the You say that wait happen that could have as happen. to based interim to interim of expect in things. to to when happen expect that. because being going you predict the looking XXXX we've at happen at actually CheckMate-XXX when to extremely on we have all end in But the analysis said that of share looking XXXX the with at we and happen on data we're when along, first or XXXX, have half we able forward to and

Murdo Gordon

experiencing lung good to same year-to-date really Australia come And that that for growth the in reimbursement, trends the we've the growth U.S. about online the and for ex-U.S. in the opportunity related having secured question reimbursement second-line cancer pleased obviously, on penetration and and Jami, and recently, most of as trends and ex-U.S. Opdivo We're, we're thanks UK of seeing Opdivo. on stable performance source the

catalyst our on about clearly, updated Opdivo at to first-line are excited Now, in data, we portfolio shares from in the anecdotal lead benefit the very in growth. U.S., in and catalyst in strong. doing patients the look hepatocellular for early NPS That's of well hopefully, having data high renal of great despite really term. near we an in beyond continue to Opdivo carcinoma just strong and if the recently first-line setting Yervoy, feedback forward, quickly, lung, we some in launching that the the in also also reviewed the benefit submitted And competition and hold carcinoma And be quickly and strong for data looking We're so cabo combination in cell RCC, guidelines the melanoma. across another also is I-O CheckMate-XXX that that second-line. strong growth those adjuvant some to going OS And will for we're experience NCCN were could from to first-line reflect the metastatic renal. trial, also the hopeful we're

So this I year would were on in know grow U.S. or the there not whether questions we

I feel lot talking as a over have medical still in data terms go. obviously, that and customer and execution read to the of do But can facing sets to you variables quarters year. everything out we think I next be a good and are we'll there would lot very of a and performance the to and been we commercial we've we strong of

John E. Elicker

to Tracy, go next can please? question, we

Operator

from go our Andrew question ahead. next take Please We Citi. from Baum will now

Andrew S. Baum

U.S. (XX:XX) any questions, From strong your activity believe, interim Three NIVO of combination can I'm What that would And the baseline to would we memory, obviously to confirm had CheckMate-XXX just assuming analysis, data. a think CheckMate-XXX? of be I to to thinking XX% for I'm in (XX:XX) patients TMB us levels, you. baseline of CheckMate-XXX, share I the mark you with about of as we say please. Thank percentage if, and access then, thinking way to about be part TMB missing Second, ex that has of definition final should by the (XX:XX) combination (XX:XX)? the in and chemo? also compared CheckMate-XXX differential you theoretical part plus Thank you with like finally, (XX:XX) you. about

Thomas J. Lynch, Jr.

and Andrew, got question. I second the third. not first the Tom you. I your Lynch. sorry, hear Thank did I'm

the repeat second? Just

Andrew S. Baum

Sorry, I'll Sure, course. repeat that. of

So TMB of assume definition, the is the One, it today I part we OS analysis. (XX:XX) has that, final of from baseline interim base – part full patient that was also should saying (XX:XX) TMB selection your assuming by that analysis?

Thomas J. Lynch, Jr.

Thank you.

Okay.

for with talk question thank So we and about study. little Andrew, – let's are let's a where and the bit CheckMate-XXX your you talk

third to think study in I study be It's patients that really lung some advanced options about think quite we best a not It's benefit, have lot is treating setting. to time, patients, studies, going in subsets couple family learn will non-expressers, how X,XXX to all-comers. idea we going a the of companies the one information study, from who in treat give than from to around of patients things in – think, in to PD-LX of out a about non-small corporate patients identify When going we it's us year cell. think studies. as how to XXXX, for And of you coming study how amount a groups we're now, for have expressers, and better first-line with of a to a CheckMate-XXX of both And it's is a more we cancer. patients more this and in patients other think family than I just the to that it's us say. world, know is pointed data give treat to how be much and about going from and a to are out

your study were said, mentioned for (XX:XX) CheckMate-XXX and things to think Now, of some about you question first able that possible. as do looking CheckMate viable one looking we've to studies, get XX% CheckMate can retrospectively, an TMB to that and comes in to we're as be And quite that we're to we I going in (XX:XX) TMB. of continue point. will a the And when in TMB. point enough the is at able at we've we it have be look important XLA said much is our back that believe time about work with as TMB And down looking patients we'll XLA, we at at study it

has a biomarker. think we as potential So TMB potential

this when in has the past analysis the I CheckMate-XXX One we of just CheckMate-XXX, for was five in interim survival question second benefits things and Your PFS and this the disclose looking earnings events only we've we in studies What response renal is the monotherapy. that the great we've IPI of in of that are have see rate where the response benefits those to months, would about those overall endpoint at await, analysis the we've we've analysis. NIVO with the rate question and at where year combination. works your on about clear in is melanoma, happier analysis confirmation and IPI and and cell, study advantages important the can that's survival the TMB our where and be an of that what analysis It And got interim tumors in interim compared year and to done of we've comment is setting. plan concept then, stat a looked the thus data been use the in We additional could NIVO. five CheckMate-XXX, will value last shown in that far. the it think NIVO. It's IPI is, on seen survival been said be extent couple a about interim not trials and of at where the a interim point NIVO seen for at obviously, results really call finally, we just with this patients IPI to occur. works And been

So we for has potential believe benefit this with cancer. patients combination great

did with experience setting. we one So CheckMate-XXX get more the that is NIVO of IPI study reasons to and in

look which we So cancer, family treat in of that we non-small sharing going the as lung help way to have best in data becomes studies it patients to cell really to available. and forward cancer, believe lung XXXX define a with are we

John E. Elicker

the question, Tracy, go please? can to we next

Operator

now question Fernandez Leerink. take go next our from Seamus Please will from ahead. We

Seamus Fernandez

Great. question. Thanks for the

around set. just already just the off, just margin FoundationOne of as then, first overall Murdo as or pushes ask as gross sense that would Charlie, test contributors the and on helpful. next the validation get general big sense give wanted about be there not wanted it commentary XXXX, sense a the a trying he certainly pushes on of and a and get So general the has relates gross to you you then and But to $XX key a better can well. – was write-down comment thinks the dynamics of just whether The And year, mix XXXX. as on think million of inventory see on just us to margin? pulls we can the for blood-based what sort TMB, pulls maybe And to of

are how using considers the study? be test CheckMate there blood-based not think XLA And validated know is trying to much. the in data on whether you a to set an I it ability whether understand that you've by set. So Thanks so to I'm got exploratory the if what can is a FDA followed typically, of CheckMate-XXX test FoundationOne as or the requires I apply, you be data comment part it – validation Bristol just or

Giovanni Caforio

Okay. Charlie?

Charles A. Bancroft

Seamus. Thanks, Okay.

growth be And impacted mix. the of us, a has by has of by by going given for and the Eliquis, For will our notwithstanding HCV gross we has which Pfizer. and you had it inventory structure our XXXX, been nice quarter been this margin XX% margin And below a million. relationship where $XX as P&L large, our forward, mix, write-off guided with driver know, particular

So margin think by have HCV, does it side. we're of on growth, also, end of lose towards although in top high-margin also And and at the the a end and we Sustiva can on in U.S. large, this good headwind the line you the Eliquis do of year of sense really Reyataz the products. although, and very the

I context about So of being Eliquis a think it in drag. the would

We are losing some higher-margin products.

So margin you can think about the factor gross mix being in the most our forward. important going

Murdo Gordon

on And in pleased quarter with in we're quarter-over-quarter Eliquis really obviously, We're seeing. and up demand sequentially over up we're prior demand trends demand. Seamus, just trends, X% that year XX% TRx same

for very Eliquis the curve So line top demand good. looks

As Charlie obviously, lower other a had products. some it margin than gross of our has said,

decline of within make to the a mind of the in net due comment to are so contracting couple the entering that an with some done. dynamics of the another did patients in third channels that sales stable our in coverage terms in increase for we position and partly strengthening I year, to gross-to-net, But can number that slight in some the some DoD overall, marketplace see showed and quarter Eliquis access on keep was Just this our in we strategic increase of and quarter, percentage some gap, is for quarter-over-quarter.

help new very of range and We, XXXX looks said new (XX:XX). good. execution what both for wide like. despite able mentioned and the have competition, quality overall, so of about holding I-O. down what good catalyst really potential are just looks of we a should we've feel Jami, of with pleased clearly, for and with we both competition for as around So in that QX to I-O number trends opening Sprycel is data marketplace pin events, the with and difficult have the in But we are, the sets portfolio very of Orencia good scenarios rest And his to trends Giovanni pin we're our obviously, I as world, Eliquis comments, the our and down, us XXXX. growth some for us do been really to because

Thomas J. Lynch, Jr.

question you cell. study we in that's Seamus, And also then, been test, our been have your in cancer Foundation three reported study the with blood-based CheckMate-XXX mutational sets on answer burden and tumor-based data that bladder to as small just the in on know, experience, evaluations, and tumor

My ask the So be those (XX:XX) and to are Roche folks Foundation. and blood- tumor-based. at would recommendation

know, mutational personally at ESMO, assays. data the terms specific looking the I mentioned looking about that these. details serum-based think interest blood-based validation at Roche and was I ask them earlier What you'd they is at real As assays. presented you of serum-based in that And to had I where in of any have stand think there a

complement whether seem I are – coming be interesting instead early think used be find I these have might we tumor-based of, that they whether will to assays, be at interesting the to think, the very assays getting promising next them these the and serum-based question or looks shown very signals from an in years. blood-based and assays,

John E. Elicker

please? Tracy, next the can to question, go we

Operator

from take our next will now Anderson We Bernstein. Tim question from

Tim Anderson

(XX:XX) mid Can Thank [Technical I-O just Difficulty] you. A few maybe on (XX:XX) [Technical drugs. Difficulty] by you XXXX questions, please.

John E. Elicker

breaking you're really up. Tim,

Tim Anderson

me? you Can hear

John E. Elicker

better. little A

Tim Anderson

Is better? this any

John E. Elicker

Yeah, little that's better. a

Tim Anderson

(XX:XX) Do burden. which your still tumor a Difficulty] Difficulty] again, or benefit, Roche [Technical out or Difficulty] there's sets. either last it's as biomarker consistent Roche's PFS (XX:XX) data this released drugs just [Technical the (XX:XX) have you at whether can all retrospective explain your data you really done (XX:XX), (XX:XX) like has is, on Difficulty] Looks in Can of perhaps kind [Technical elapsed, And clear are been TMB, of if [Technical non out kind that? not? analyses confident benefit even (XX:XX) analyses more Difficulty] and you mutation analyses [Technical any point OS data time question, of (XX:XX)? I-O from you data, [Technical CheckMate-XXX publicly of with of [Technical CheckMate-XXX prospective Difficulty] assay, XXX% Difficulty]

Giovanni Caforio

this is Tim, Giovanni.

So little. unfortunately, a you were breaking

First question, potential into opportunities XXXX. study I for believe, was about starts non-oncology assets registrational going and

NASH. LAG-X, three As on actively are working our we and we've important mentioned advancing in programs, program IDO, before, FGFXX

will as that we also the TYK-X BTK seeing see forward well. months, we few next the and data look program. to And program the data Over on proof-of-concept

outside So pipeline of and oncology the in is progressing. oncology

questions. I had answer and really You I PD-X you there we the respect test, was give a TMB. to believe, our report is perspective there, whether any potential the on Tom to that availability question, with and but perspective ask two data also don't to have any news One updated think there on I'll answer is,

Thomas J. Lynch, Jr.

meetings. we PD-LX test shows that Yes. hard is I'd was it drugs. the do PD-LX question. very, and very believe their Tim, recent the by that hear is to which Again, companies similar we is used being test, regarding apologies, say, It other our we to that at evaluating have reproducible data presented

patients your look rate think able is will second look important. all any and was would response rate we biomarker, its incredibly to would ability question about. say to overall any any we which at at, predict response I with would and PFS overall survival survival, look become determine as be the question that, to I we and that's that of And group data PFS in sounded important. set TMB those in at, what about endpoints given

show And and that PFS immuno-oncology incredibly is I we think OS balance studies OS between important. benefits. is relative that one the love

that a but future. that's hear. future, of wouldn't our a and of become in will of not And as reason in patients that's agents the I third-line I'm think second- are look don't look in many best if excellent believe more to that often. would show And any patients group of selected in other to may PD-LX PFS we you at we to sorry asked, group exactly think, I there's beginning what at activity the we our as the ability areas, something TMB

John E. Elicker

can please? the to go Tracy, next we question,

Operator

ahead. Guggenheim take question from will We Tony Partners. next Butler from our now Please go

Unknown Speaker

are Hey, we this Could patients, is cancer Butler. what your patients comes tell data given as do variable to highly And IDOX you. see mutation fact So, do high? you little Tony lung Daniel TMB, concerning non-small you (XX:XX) us a problem second initial proportion IDOX of a inhibition? individual non-small about is can or frequency you think cell at SITC it data we in IDOX from see cancer for program? when the cell the lung efficacy inhibitor some question expect maybe that general, in and, TMB bit Thank across TDOX what in would is then, that

Thomas J. Lynch, Jr.

first Tom. I'll this on is two IDO. answer [Daniel] Thank (sic) Tony the you. questions So (XX:XX),

I'd things think about couple important of an the think a at We three years. I to past Bristol-Myers general. in for and we two this IDO say is way felt IDO target,

we're inhibitor. BMS with we purchased As as we with partnership Flexus inhibitor, a the know, you IDO colleagues is which strong IDO at well. have as now data you that And, our from presented inhibitor doses This our know, with we that Incyte, receptor working see the at and compound levels occupancy of to pharmacokinetic AACR this inhibition year. advantages that tolerated at patients. suggested some may excellent well be able we're IDO to see good We our in and pharmacodynamic there and appear kynurenine

those PK/PD differentiating know. be whether we dynamics will Now, agent, think the don't to I

But important talked with patients. for if endpoint. tell think us will think We IDO. about also in so matters clinical cancer, Bristol plans non-small only lung the it it we IDO Incyte, and are with an about I is begin studies, our that melanoma studies separate lines two we've think we and proceeding our with much have we trials cell plans in and of registrational to

clinical to expect. want on what to we and year, we SITC mentioned, presenting IDO this say that of data to meeting. things seeing be a at you the couple as about efficacy Now, at look SITC will data our forward first I

into remember, a You studies. we're this where agent remarkably this registrational the has been point Phase have beginning way to development from now all of the I, quick

the so, emerge. take to does And time data

very two seeing seeing but you'll or most there which importantly, data, will some at to SITC the well. on SITC, think we out one be data You safety tumors be efficacy is important as at meeting some get

safety data presented So some this some will year. and SITC up coming at efficacy be data

registrational will on our studies to be as of our year. drug the at first So have again, our mentioned, IDO end important we drug. data this And beginning that studies we our with expect

mutational Second lung non-small be questions in comes about TMB, and what the down cell frequency set thinking of again, to cancer. will

what at safe that it's point. still something that this not is think I believe to which say XXX% this is we known

know different this a say group patients. non-small in I those of treated number this it's of To what prospective really at see that until prospectively where really the XX%, to think cancer really of studies cell you it's doing at lung what wants really what is substantial bands the stratifications need is CheckMate to like. the point is, have I safe I to group think think an you think fairly do we're to like portion are looks I final overall with of one TMB of patients point XLA, prevalence to that will this generous is TMB whether do think it's and I sense treat. what a think that XX% of in we patients where you percentage see a be, and important

you that it's percentage or think may lung with as elevated I cell TMB. important non-small of what qualify an having can definitely cancer patients say is higher

John E. Elicker

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

Operator

We now will JPMorgan. Schott take Please from ahead. Chris from our go question next

Chris Schott

Thanks much. very Great.

here. Just two questions

much. PD-X in we relative about as you're second you to Opdivo-Yervoy the to that going think forward? Thanks commercial thinking studies guess whether And here influence I in know do First but products? you to we think balancing predict a which from combo seems also the of it's I additional different study opportunity A, response can TMB. types. in on or very tumor tumor some any markers that this these that dose, combo either different see My both indication, about your running or just, coming was as as about around different confidence, back question the talk B, predictive using some CheckMate-XXX learnings how types, it's renal, status,

Giovanni Caforio

you. thank Chris,

you for on So there Tom. some I'll a to ask are and couple Murdo questions give of renal, then, perspective

Murdo Gordon

Yes, thanks about regimen Opdivo for really our opportunity the in we're question, Yervoy the the Chris. I-O franchise, frontline. total renal think When we plus excited about for

the treated terms of opportunity patients. population, second-line in in size opportunity frontline roughly the of the terms scale-wise of twice is Just patient

about think the you X,XXX if first-line that double the So RCC about second-line to about in per size you're being in the of treated year, patient U.S. setting. population

overall cetera, think there'll I survival that compelling obviously, that SITC at a a demonstrate we've presentation little an data I in able for very, depending us. in be is and been very So opportunity trial could think interesting for while. that to And on et update labeling, be what

have in nice a materialize you a take We the holding. malignancies. and might because than effect right over longer is in of And on now job to will slower-moving done in malignancy second-line TKI's share other see versus progression, second-line terms this XX%

So an well, going at of year, second-line. for to and next a robust least first-line, if continuing have you're nice in uptake in goes overlap a all business

Thomas J. Lynch, Jr.

cancer. with some I'll lung now on follow-up comments And Chris,

different I've So I the were schedules. regimen. to CheckMate-XXX can bit slightly you we're patients as you're little first from tolerability. is looking what think what was read-through I because can to to on in And and happy that on, in to But tolerate very is you regimen able really And think, difficult a the it's past, lung different efficacy, I it the read-through from is think, about tumors well-tolerated what and a so renal CheckMate-XXX at CheckMate-XXX CheckMate-XXX. question said read-through

three very Opdivo (XX:XX), is CheckMate-XXX of one. Yervoy with know, similar dose Opdivo-Yervoy, being being you the As

renal. lung the Although continuously regimen, to cancer in given is Yervoy as opposed the

(XX:XX) So part the the us be gives looks good. duration, will toxicity confidence of similar differences there's in tolerability slight early the tells length that but the regimen of and very the it of us but

that's dose And critical, if because you tolerability see the likely into And to obviously, benefits. you're so, get important. I patients, is that not can't think

to good setting. it's that tolerability see in So

I ago in months interesting good relate studies I medicine to done thinking the on translational you preclinical the it's trying beginning good Your really and to how translational of is marker. I at at invest about to is Six science how our can this it ask Bristol-Myers does is an for example meeting, can when important our important of one, and heart second a medicine see very a we're question R&D be from perspective. SITC TMB and gets look that. do you And Squibb TMB PD-LX to as translational what started, you a really good that. We've me which you to lot a as is do at see – We're of to work going space the to medicine be told us and relate TMB which capacity. brings a and think again, of I to cancer. question Dr. both Bristol-Myers design medicine we're looking translational wealth to terms drugs tumor the this patients? how IDO, he in LAG-X appointment these back mechanistically. at separate cancer like terms space of non-cancer happy will the as of we to thinking question. about other lung and year, and in in now of data experience our that OXXX of the me very and And of a lung is Saha, diversity PD-LX in do And who Squibb, how again, leader about how And sets worked drugs, of also, brings of cancer great Saurabh they in each the the at announce and new have person, markers

the TMB them. that PD-LX to from episodes seen help are have what you define patients define fusion, We think of know have examples to We we ALK EGFR, don't occur while These certainly questions relationship of or ROS, RAS, usually we're can most have going the kinds have benefit between we groups PD-LX. and we where we have EGFR co-mutation. to that we of be to ALK, have exclusive, that have we of need drugs. that TMB, situations see are, already can both going we RET have are We to tends have our and RAS us but we together, that prospectively and

of at look years. really in interesting couple the to questions So next

John E. Elicker

question, can we go Tracy, please? the to next

Operator

We David Risinger next from now take ahead. our Morgan Stanley. from will question go Please

David R. Risinger

CheckMate-XXX. to the on and wanted Yes, I for of thanks couple follow-ups just very all providing a thanks details. much ask

occurs message what means? analysis low you. second, TMB So a And of given part interim press we versus Thank once medium materiality, could on matter release CheckMate-XXX expect no the then, are? results the the you your be the should used look set, just going Specifically, on versus please? to endpoint as primary what and high clarify CheckMate-XXX, the if you TMB is

Giovanni Caforio

David, question. this Thanks Giovanni. your is for

the say, Let respect the the the discussion said final had is we've very really the today the with at any plan. additional we the statistical to timing analysis, timing on with for respect analysis, this and on me And interim we've consistent a just retain are what the in potential with to for before CheckMate-XXX not flexibility insight position to study. provide point, we really

John E. Elicker

And I evaluate release, that regard with we'll press to think, time. at David, our the

that. can we on the think please? Tracy, premature I to go next it's speculate question, to

Operator

from Suisse Suisse. Divan Securities now K. will next Great. take go Divan my so Vamil Please taking (USA) for Thanks LLC question. question much Credit from Vamil Credit We - our ahead.

think PD-X us curious monotherapy, I and on if just right little can going the the with on you terms (XX:XX) combination just more just U.S. to saw that's Just I'm CheckMate-XXX the have following see monotherapy that a CheckMate-XXX. patients discontinued color comments, academic the Is better market is I much give was of to it's now what's And in do adverse likely you XX% prior in side. we still Thanks. and on there? on I melanoma the where Is think lung. think of and (XX:XX) a read-through in mentioned community-based to to you combination, focus where curious, due you how safety with percentage about up events regarding need about question, doing ex-U.S.? okay see with doctors think combination there then, level with discontinuation maybe one of terms And on profile the how the maybe just effects we did a of or So the or that the side a cancer that in of centers in versus to difference use due all second, Yervoy? you lung it's the more of data? when use

Thomas J. Lynch, Jr.

need drug get the So but the into Again, cell. of question. impossible but this that a valid is or is. it's CheckMate-XXX in a It's benefit is, a in Vamil, you we level did to at renal can you we patients not, What thank seen first data, interesting answer to the point hypothetical, level your you you level it's that really raised know benefit. not discontinuation what terms force it that lung really is do what can't of survival point say it's Whether very in was see question. for that to until of in very see seen

Murdo Gordon

melanoma, Vamil, shares metastatic continue the we (XX:XX) And on see really regimen. strong just for marker Yeah. to first-line

combination. So all roughly And XX%. XX% Yervoy another Opdivo first-line you all plus monotherapy, metastatic new of add in up receive if then, about melanoma remaining patients it's the

Opdivo, in adjuvant to percentage with some what's Yervoy. in the dynamics metastatic, will the dynamics change a large FDA, in got an and in a guidelines seeing of setting, the then, update future setting, happening percentage the in the KEYTRUDA. We're NCCN approval which and on expect in we hopefully, uptake adjuvant you've from change the Opdivo would rapid changing some So of large the made combination, so also rest that up will also of

declined if with at X-milligram and the So Yervoy to be combination used by some adjuvant, that's in then, metastatic. off-label looking in continuing underneath just use on Opdivo Yervoy sales X-milligram to the you're be extent currently will in being Opdivo sales, replaced dynamic

forward, BRAF melanoma So in mind Opdivo to our trends strengthening have going but very trying performance keep patients. plus to as dynamic regimen, our about focused total just you we on some on in think a Yervoy and improve we're

John E. Elicker

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

Operator

go ahead. with Gilbert Deutsche take We from our will Gregg now next question Bank. Please

Gregg Gilbert

time story? the have yet, time a cleanup sort this you depends is you, of you do on NASH as year, infusion And read have but benefit, it that Phase that buy-in on based confident just this on a compound, how it on readout Tom, I settings? Thank how ready, melanoma more is data, just Phase know other across FDA's mentioned, I is next you shorter of the also melanoma, or in angle, relates Incyte's a Halozyme Secondly, the say first compounding to to of terms important chair you'll to there Thanks. think in IDO III II? you both are half in folks. but the did you few. collaboration one

Thomas J. Lynch, Jr.

thanks your question. Gregg, So for

decision-making because more things influenced little some own our about have, we seen of the regarding that give data think we've upon that first, promising IDO things with the data a epacadostat color are What the Incyte, depends seen it one as we've I the with So epacadostat with with that we've you seen of the Opdivo. epacadostat. Opdivo, data, interesting that's a very will saying our one class, drug, and of than and I

the at will as we certainly forward. from of us think looking and epacadostat, think I that And to that readout go be Pembro comes interest so, I

be types, we cancer neck how I it paying very I to to we whatever that. relates mean, relates cancer cancer attention melanoma that's and IDO obviously, will, other at – difficult and Now think tumor kidney But in, other lung this to how know. and to and look cancers

in are targets. couple I and a that – think have here about in differences or difference to Small things there they antibodies between remember a they between can antibodies the and for you group methyl think toxicity. molecules and molecules, activity high there's remarkably with could antibodies, you do differ, and both when specific differ small differences have specificity their explain by

end, a have at does it little looking readouts we agents the too across you're ultimately, correct different I that. to data, careful much So the think and, upon about so about of depend be

session be area discussions data were to an hepatic the I'm at the that We're able FDA, with of NASH. study be where Liver The were the fat. our Meeting to consultation coming able middle ours, we an in an that from to studies look and of them. will is up of drug, presented, oral our in meetings, final really reduce update big know, that presented and this and forward showing with meetings able where the to an a liver to register order data Second to again, is FGFXX drug very design be area, with we design to important and we're our sure It's at be appropriate the what with in tremendous number are – these of excitement question something last And including excited important to companies, terrifically and, you down in. area FGFXX comes were as week we a

as biopsy a like that at fat that that thing is like biopsy they'd is to do where able we said from that see I Bristol-Myers, last think one they be III was comment data to they and to important trial, Liver The that FDA to enough, that said be probably companies, specific week believe had, won't basically much and drugs to Forum the not markers indirect demonstrate more a surrogate note Pro-CX be or in hepatic the all were that Phase efficacies, in will that was or setting. that to necessary developing companies

So in FGFXX. and turn looking our of in forward require on studies. for Halozyme. operationalize being I'll able biopsy with to look we're moving plans as of options on clinicaltrials.gov, our forward this, to it terms And you're it timing how we the to an But at over Murdo will those correct, announce, to endpoint

Murdo Gordon

office-based partner with this future. opportunity distances. travel technology. where a in It to about their move we treatment, are excited there's to hospitals, of of convenience highlight, these of large infusion version patient and really large may versus particularly from beyond this, that chair infusion treatments site timeframe also we're academic on to But have in terms Halozyme, care on injectable to think benefit an an On products. our Gregg. And they Thanks, if care one-year them may you and take place is more site Yeah. definitely of patients have academic possible time centers, having cancer beyond the yes, a version,

So one that's area.

different over have we use in technology potentially might different allow payment The advantage reimbursed U.S., in injectable improve us so a the we least to patients other combination that least, And is, this another about in ways, assets last receive as be again not will XX think that a about the thing agreement at one think how to with their future. in that's something different in to administrations. this but through an product could potential channel,

terms also related and And payment to is outcomes think forward outcomes experience for patient of that new be reported models they treatment patients. I this could something important. going how is in Now,

strategic to agreement. number a of different advantages there's that So

Giovanni Caforio

where as continue Gregg, on combinations, let of for part we because strategy me A a really terms resources are comments oncology important limiting U.S., of just the the and significant really that, number hospital in U.S. number in Murdo's is development, in level important lead on the business a it's of with company, of part in assets of of delivery our to given innovating have I sites to add factor. constraints models. the our some as the think cases, outside is, potential distribution the at

The types has other beginning, say healthy tumor and patients that us thinking accelerate you key are immuno-oncology the the look been, adjuvant would going really is as thing for setting. one important about across very priorities the adjuvant And models at when to I is in be clearly, delivery of different our clearly, (XX:XX) multiple from to that well. setting, into

John E. Elicker

the Well, one the for bottom have question. of Tracy, hour, more we we're up to time coming think I

Operator

from question from will now our Barclays. take We Meacham next Geoff

Geoffrey Meacham

thanks quick and guys the I morning, have Good for ones. just couple of question. a

make looks stable but be start U.S., Opdivo you. flows to trends? to sure on new I-O. wasn't combo is as patient I are follow to de-risking the make further up Would question committed foundational sure in And us can largely downstream? used Thank CTLA-X earlier an on first-line trends. it impact second-line sense then, in the quarter, wanted I important guys overall gen an mechanism for the KEYTRUDA program. you as to tell next forward? having on You CTLA-X what on needed Is and in an what that going lung

Thomas J. Lynch, Jr.

combination the is delivered to the to us. incredibly impact for I has earlier continues to thanks we important We mechanism believe a patients It's for think, continues broadly. and on Opdivo-Yervoy Geoff, CTLA-X. and So that improve as said that again, CTLA-X deliver question

gen very some has CTLA-X are compounds. that believe One do year. clinical this that we're Now, greater very And is there to second opportunities is two again, trials which that hope for the And partner, our have begin our that with to the at entered formulation, soon. clinical at there them. and CytomX, trials non-fucosylated in exciting and is looking seems the looking Probody potency we looks that we of next technology

two foundational and those with would at approaches, agents to point once I those the inclined either forward of So see evidence of move efficacy, both offer a certainly we for potential have believe be think partner kind we safety that the CTLA-X patients to as to Opdivo. just I potential down now, do road. that they the us – of have benefit like to the they that is

Murdo Gordon

That's Yes, commercially and are second-line, medical just as organizations. and our mentioned, Geoff, on nicely. performance up the shares, very a strong holding you with

pool We immuno-oncology are second-line seeing the lower on of slightly eligible impact patients.

in seen in agent So an percentage of in neighborhood I-O before. the who terms have that first-line not reduction of volume patients roughly of X% is

as so the expected. So that's little less to first-line, Opdivo. of is a We're and share of bit a helping than also that's Pembro penetration it's holding anticipated, non-promoted first-line reduction With onto we'd in that some we (XX:XX:XX) respect also stable.

Giovanni Caforio

everyone. thanks, So

quarter trends this the of let execution progress was fronts a me continuing pleased summary, We in commercial the the execution. R&D at a in for overall. respect with call, good I just pipeline am end number say of on Just made strong with good to and us.

again, a We to set you. ahead events us. talk Thanks, And look of day. have a number to of good have all have obviously, of opportunity and of ahead to important broaden to which continuing, of us, the the opportunities continue to I we have forward

Operator

today's concludes This call.

John E. Elicker

Tracy, thanks.

Operator

participation. your for you Thank

You now disconnect. may