BMY - Earnings call transcript Q4 2017 | Bristol-Myers Squibb Company

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Operator

Good day and welcome to the Bristol-Myers Squibb 2017 Fourth 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 Elicker

morning, good and you, everybody. Thank really Thanks Monday a for joining morning. on

results to a XXXX both as lot have discuss outlook, XXX. of well our We earnings, information today, QX from as from our

don’t to read deck we We are do. the going today, slide which normally

So, With list, company's have have not Reform Bancroft, Chief Private and Safe subsequent the indicated results documents of me remarks. CEO; are of available purposes Caforio, the factors, XX-K materially XX constitute of recent relied from in and as our Form that Giovanni, should this added also company's our two, language, annual presentation various the Form Any may including available Officer. by Tom and website Tom future distribution most Litigation SEC, Harbor XXXX. on slides Officer, report Commercial those upon these our statements the On the important estimates available and XX-Q Financial our Chief on X-K, as forward-looking under our Chief the Actual results any Charlie discussed Investor ago, about morning, our differ those reports Securities estimates it our the Q&A. are be are the Act estimates on then, and Provisions, Scientific and is of be Lynch, of day on represent or plans representing on if forward-looking Charlie will and Group. review Relations about date. you on will as Gordon, Safe Harbor The I’ll we prepared minutes our Officer; prospects our website. as our Giovanni slide And quickly. Murdo for contains

at comparable expenses, certain so, presentation in costs, to financial While our estimates some like other Giovanni? to future. if of specifically disclaim available include statements obligation even financial items. are Reconciliations non-GAAP non-GAAP which The gains also forward-looking we measures certain the contains do these specified any most and We on or point our measures, to update never adjusted GAAP the are losses to website. measures change.

Giovanni Caforio

Thank morning, good you, everyone. John,

today, We call. the so of me to an overview discuss share lot have let a

As of treatment have understanding announcement I Cancer we on that innovation validate through and and excited bold our to its details the our what results science core is a our Program. this made to really all. you what Based results few we patients the of research, proud, have morning, in approach. And our treatment cancer of as in biomarkers, for seen, These strategy. of cancer. lung of understanding minutes. on disease, exciting we the has as consider break-through the the will this for cancer. results innovative am advance of lung an for Today’s this made through We R&D the Tom organization in our of Lung to you changes and accomplished, program our a walk means a today’s example are

announcement. to little this, looking growth there to discuss the talk multiple call. it longer started Francisco Tom? in quarter oncology good last be see month, are good drivers, to will in well business our the From will that overall momentum oncology XXXX, XXXX about in are focusing in there very a I and we a announced, XXXX, performance beyond year. opportunities Charlie that with which more we outside And over term. handed for more on position us starting as also We share strong number with later and discuss I’ll And San perspective, in that of we in my detail. Tom, today’s and this I’ll

Thomas Lynch

burden, Today we progression to chemotherapy, free Opdivo six. could I combination we're has patients both If at met or as announce in announced, recommended co-primary Giovanni. of PD-LX Study for XXX, And also the a you, the Thank are survival the CheckMate-XXX. in Part trial selected high everyone Yervoy for the DMC population And to TMB, with improved to PD-LX looking excited, for slide survival we mutational expression. pathologies remember, ask that versus turn endpoint, of continue that XA. regardless the overall to in tumor completion

is in a planned clinically meaningful. is difference PFS statistically data medical I believe this cancer. we results will advanced meeting, the patients with strong present now make for can tell I lung highly upcoming significant to what that and While you this that

patient a just into effective began and marginally biomarkers and has PD-LX I this and put and only significantly list regardless cancer that define the ago, just brought EFGR, Today immunotherapy lung biology context. XX name ROSX, subtype we combination first benefit by options When drive who diseases patients then, treatment. PD-LX this a of Since to RET radiation, group clearly toxic. to distinct defined add from related both cancer Let's years chemotherapy seeing of one of treatment status. their become few. TMB to ALK, a were

CTLA-X validate TMB further we in the changes we've importantly, said, from As And survival Lung the combination a trial to most results design role company. evolving. randomized we analysis a light science Opdivo-Yervoy is overall made the where now tumor demonstrate of results the I've the with of data in forward Squibb the driven look benefit the These trial. mechanism. our XXX was as importance today the the cancer showed capabilities population. third matures Perhaps validate and the is science how and consistently the in to translational of quickly strength Bristol-Myers innovative the

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studies. PD-LX expressers, was XXX looking designed looking at part at XB two non-expressers. companion Part know XA as originally you and As PD-LX

all important these data were more made As we three key. evolving science emerge to reflect the to XXX of changes

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to Now X. if ask could slide you turn

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could to XX. if turn slide you I ask Now

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gastric significant with XX with combination Beyond lung out reading cancer, over the head and the data cancer. have we and months, hepatoma, Opdivo lung next cancer, neck trials in cancer, in small-cell milestones,

are biopharma areas a back cardiovascular as it we continue With I’ll most Giovanni. As disease, as opportunities accelerate in am science development promising and turn excited company. those of to and science, immuno-oncology. about neuro of that, the I assets driven particularly well I to had fibrosis said, areas, our our across the we

Giovanni Caforio

is an reiterate excited by patients I the you, lung result what ahead Tom. proud, Thank and important are for us. accomplished. that cancer of has very This of we I our opportunity want organization am to really

was execution our please. commercial Turning to a slide thanks very strong to year, in XXXX strong and progress programs. good superior XX clinical

are trends our entering XXXX, business. now and in momentum with We good

XX. slide to Moving

the business. We business, our prospects. in beyond the that are bottom in about good and strong position, and and am our with grow There of are can growth, line starting XXXX pillars number very really in top year, a I a excited in

a is important Eliquis for growing franchise First, very and us.

we see has going tremendous today. grow. strong results leading As indications XXXX, approved the excitement existing and Eliquis First-Line and and into NOAC its With is continued a announced the continue Opdivo momentum. Opdivo, XXXX We to indications, exit about our to business has across for Lung, beyond strength the current opportunity the

for to year, And and of focused even sustained and we more build adjuvant will We have Eliquis growth, that confident, that XXXX, study that we continue - today’s a a renal, year number First-Line of I upcoming Opdivo. driven today’s for readouts with opportunities into the year, data on, forward the role opportunities a this next including announcements. beyond lung on and play looking I are XXX. cancer, and later in see by melanoma first-line am With PDUFA thinking meaningful important this we will results,

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year and billion Based HCC. from in near seen have year, we this and cancer. will we other have outcomes. our potential, first-line in areas on the With are program opdivo on next unmet dollar focused, driving of X medium from across areas, these where tumors, and with Phase and presence anticipating important the Diseases what a growth a and data poor gastric believe with term. on and care Phase X data indication, need Two high renal the are plus Opdivo we the cancer readouts in these our continuum X

In small-cell addition year have cancer we important lung neck in this, head later and this to opportunities XXXX. and in

several promising history Finally, opportunities contributing with growth. our of all therapeutic is our to emerging sustained pipeline areas one the across most in

programs see forward, to pipeline, several this development and with TYK-X such of in moving We next the year. and from as FGFXX LAG-X we'll are oncology non-oncology stage moving excited IDO and where our

All me requires and our and in the significant gives of are what behind doing to say resource R&D And were certain XX spoke to to doing right are to future, operating year commercial slide delivering continue today, that. of just us I'm we our deliver on are of we work and And I I our pleased confidence capabilities, level just described in our about ahead we approach the The investment with company, ability the model. A please. opportunities disciplined turning ensure to to evolve across to a allocation. ago, strategy.

better a We competitive. are fast more is moves creating company, which and

continue commercial will in capabilities to are With Bancroft, financials. discuss that, over some medicine, our a our on will thinking support the specifics capabilities, are particularly how I'll critical we who forward. pipeline growth. going to hand Charlie strengthening focus translational be future in and we and These We to quarter about and investing are it our

Charlie Bancroft

Thank my you, winning Philadelphia Giovanni for Eagles and off exciting very Superball. Tom, comments, the from all your tapped

Let XXXX robust good growth, with very saying, company. we execution driven across delivered the earnings strong a and by me start by revenue

to XX. slide Moving

quarter tumors While billion renal prioritized $X drove XX% the With on color exceptional full cell. total provide just saw and X% we product on brands strong sales for a worldwide trends are Opdivo. for previous in billion that, the other share Similar I'll maintaining another our growth. Giovanni quarters, in of seeing almost our grew key EPS successful delivered $X.X revenues lung were and were The year we basis. our in Opdivo was the year, It such strong line highlighted. to brands some leading revenue franchise. performance as We second performance as on and solid in up

melanoma market rapidly U.S., the line and France the to the has lead the Opdivo continues Opdivo markets second Opdivo While trends setting. we of are such in penetrated Germany, seeing adjuvant Japan. uptake early, are HCC and good key in Outside as

sales Excluding the XX% of in deferral were sales XXXX the impacting international up quarter. QX Opdivo over of

the Opdivo both we strong for growth trends meaningful in in near these opportunities medium see With announcement, and today's term.

Turning to Yervoy.

sales U.S. adoption Opdivo on pressure adjuvant seeing setting. are due the the to We in melanoma of

the of franchise with line lung. expect Opdivo melanoma forward, Yervoy. to these potential renal launches we first and growth Going the outlook line positive trends the stabilize in expect cell our we and first than were in adjuvant the offset perspective, remains of From more the erosion

substantial mind, the brand trends is commercial in strong we this new-to-brand growth sustained share top also Eliquis execution growth resulted and leadership the In are TRx the similar strong Our in for forward. its NOAC XX% seeing -- of Internationally, markets. in with Eliquis of almost for performance in in well momentum With share quarter. across European market. believe position period positioned we going the U.S., portfolio extended leading

non-GAAP The our which growth most gross strongly be margin virology strong I’ll mix. influenced to declining our continues on Eliquis by in and slide pressure start of the to and erode franchise XX turning product P&L. of our of Now margin quarter. with

And new years. reform rate, taking primarily tax were Medicine thinking reform the of important licensed transactions to into respect and for OpEx relationship late the forward. model see within quarter to remains comments to tax no we earnings executed building R&D and top to approach investment Business we last change was tax allocation. development in on to over our XXXX our our we technologies the resource longer Moving we during was Foundation clinical will was going allocation, our to we ongoing teens expanded new while balanced capabilities, We we partnership to enabled few This With be which our driven and turning our account With prioritizing acquisition slide that favorability translational assets operating priority and Giovanni’s high expect capital executed execute and increased spend Halazyme examples ISM by about the us several continue very in in we tax mind, in with entered are by transactions. in a year. coming The with evolution XXXX and XX stage a rate MS&A. mix. in active collaborations. XX term

shareholders annual to a we dividend, X XXXX. committed consecutive bought to Taking returned With respect billion remain nearly we also the We our for ninth in increase. year. marks billion the to XXXX together repurchase, quarter over XXX million and in back X.X

Turning for to color slide XX around XXXX additional guidance.

from certain of in impact continued accounting the the On Our driven EPS growth be by to in how represent margin, offset pressure rules and additional erosion change of million non-GAAP $XXX are and gross virology spite strong full of year the to Eliquis over recorded. roughly expect the we by XXXX guidance somewhat growth royalties of be growth effecting Opdivo.

continued Our the on educational we commercialize approach in note MS&A. to investments conjunction guidance TMB. with in the prioritization efficiencies OI&E. reflects includes A efforts R&D announcement, on supporting OpEx while today’s In our drive quick

We have receive and royalty AV therefore restructured our a royalties will future in rights XXXX portion and higher XXXX. of

Our tax over years. for reform In to rate into across with strong solid conclusion, next XXXX execution tax of the I XX potential as we favorability account mentioned few very further the a have board. and the takes XX%

today’s We John company. to it the are positioned announcement in I’ll the increases outlook well to our Q&A. back turn and in now grow for XXXX growth for conviction

John Elicker

to Thanks Q&A Charles to go session. we’re and ready I the think

Giovanni Go So any please. as as as questions. we well for have here reminder Murdo ahead a of your

Operator

from will queue, first Fernandez Please open. is Leerink your ahead, Partners. our question take we go And Seamus Instructions]. from [Operator now the line

John Elicker

you. Seamus, we hear can’t

Operator

now Please Markets. Capital go Montreal of open. Bank line from ahead, Arfaei is Alex Sorry, your

Alex Arfaei

And on not is survival just being well. you Good TMB on questions results. the as the curious, monotherapy is for evaluated, encouraging you much. that we overall opdivo very come I very know results very from taking the is much based setting. am analysis? in morning, and congratulations TMB in also CheckMate-XX thank not showed this Thank Opdivo included monotherapy why being How

Thomas Lynch

I’ll in I I second one, these talk one. the we will a end first one me points about think little can bit than thank quicker, take the and Alex, questions, both the let of take just you. second do the probably

a TMB are which fact So, test so endpoint to continuing reporting we are the reporting in is in is overall maturity. co-primary there a everybody, we’re endpoint two the co-primary what in that second the just we endpoints, reporting combination is today co-primary and were the PFS survival which remind the the high for PL-X group group therapy, for the

have We overall very not mention. seen to data, any I important survival that’s think

overall So, data. we any survival have not seen

The that we data we to going fresh any look is look to those the us, also say, thing publishing are to The call. on second forward meeting as reporting forward be not soon important endpoints we we in reporting to is to secondary very possibly can. and medical as

about few and say Let me just a endpoints trials. things

So, a things. of couple

that, I make think PFS statically whom large very get powered able doctors about for stress as potential a population. a encouraged significant good does both that are very say, well significant see use able its overall by be really in benefit PFS as clinically is particularly result. well. OS, to and the in something highly also survival and I good are physician want decisions. else today, TMB sense trial, we predict endpoint, when to we this spend and that of important I’ll its are both to with I to, have the PFS endpoints, This that think benefits that patients, very and you PFS think a you

of drive to it factor is treat will the and important getting, excited is think, think people matures, also I I sure this deciding, that’ll people groups, across seeing you forward am TMB data, that is PD-LX important we something we look for I all was one decision-making point doctors is OS to when are about PD-LX group, negative. home it decisions. other like we expressing not because are and know seeing I cancer, right an just in things, stress think the you and important the think doctors, terms with point with that that’s PD-LX for there in to also one Alex, want be be when PFS, important, the that their lung some to now, how are who of another immunotherapy making

is low to from - the that setting, to opportunity who opdivo I be added more think to what about TMB we that clearly patients, could excited benefit identify gives dose in not you today. us, tell

Operator

from go is now you, take and from Fernandez open. line question next we now Thank ahead, Please Leerink. your our Seamus

Seamus Fernandez

great. Okay

Some on a the first system on Well, in of Boston, eco said, my from of phone the problem was eagles event. with it the so here. unique what sentiment you

Charlie. thanks that comment there, for So,

TMB. Second, in the to creative study terms of Congratulations the difference design. in the on incorporate change

benefits you and give on could or us applied Opdivo combination comment on a you Yervoy? is whether clinical to the of Just clinical guys you or I color think complete a analysis of monotherapy? over more the the of hoping longer-term the but bit bit know little not then about as relatively have understanding that the And a secondarily, Giovanni. TMB plus do of combination that that did just we opportunities margin, the the on the significance, therein significance little Opdivo

way us after the think trying is plus little combination overtime? to Thanks. as that information cancer Again, but how is into you're combination therapy given the regimen sense we're treatment concerns we're particularly Yervoy a about feeling a the Just is are something that lung you think confidence how of dynamic just that significance of get regimen really work a Opdivo the X-week some better as a give you could clear, safety to I going safety its directionally that the continuous continuous the you at out color least on bit plus guys there? or Yervoy treatment hopping Opdivo seeing

Charlie Bancroft

through I morning. sea have Patriots I've don't of got a it. get rough in hard fan, been Patriots a I we say the If as Eagles reports, fans XXX die think it's to didn't here,

are me of let well points So, think a I that your and are couple crafted here address important. just

the first, I feel spectrum confident I'll selecting we're mentioned, are agents that of I agents. TMB biomarker. a like important. going first as IL story benefit looking And the thing powerful Because across at say including TMB I and The this next-gen story. patients is And both a understanding looks to Opdivo-Yervoy are biology, both most. very very that an our is think our

as the part we're The settings. Yervoy And Opdivo, second and comes big Yervoy thus very Remember, of seeing a benefit I of me, what cancer far Yervoy the now of it have that that how in weeks in tell non-small point for want not terms just down that felt contribution forward. that extremely is important cancer in lung a be being data melanoma, move makes And well to Yervoy every number analysis us cell and confident some you given benefit as has today. the in advantage And by well part X as performing Yervoy benefit cell but well. patients of can is mention dose it's is? components renal is you high. said, And in I for in that's I time low of can case, and its we tolerated this of what different our this to is

both is for story think I to over thoughts. a his it I'll TMB it Giovanni combo and that about really So, turn just it's the not or

Giovanni Caforio

So, comments. couple I just had a of

about is of seen really type, and cancer. reinforce saying tumor cell the excited us makes This importance again, Tom So what this lung about potential was that data combination third the combination, first which Yervoy. of about the renal in want we strength melanoma, non-small I now, the Opdivo have to of all,

important. work I'm second proud Yervoy is done so as it optimizing you the The combination say totality of our of And the growth really that's part also schedule in the and important Based program the have strengthens quite parallel far and regimen know really that we've data because I for want that that’s important, of the the to think I the we our the has think in are that thing confidence only actually and outlook cancer of I increased. dose on the company. that overall broadline seen

important with it patients for think obviously really as well. the starts a So is time but company this overall I

Operator

you. Thank question line take ahead, your from Please next Jami Sachs. now we’ll And now Rubin Goldman go is open. our

Jami Rubin

Thank you.

population. with and patients XX% is I high expect the that said I press patients XX% because back XX% by Just of KOL the frontline are what this that release of but maybe implications high first you the a TMB, share how you we but typical effected I this could please your TMB, know and size go And talk that about TMB a exciting curious of of doctors look market, is couple if TMB. about new can saying address loan you of of market at of of total questions, in ask just practice. or and the is is commercial if payers their CheckMate-XX, market think evaluated the XX

of into and the you you So, And confident hear you survival that hitting question overall did if also earlier Tom, in XA just then would that earlier think for wasn’t how you I and are lastly, clear very highly lastly I is then you at right? now look this study the although put perspective. OS and registrational for trial? congratulations. just could maybe part say Thanks in that TMB did you and much I and

Giovanni Caforio

Thanks Jennie.

deliver we that approach has were Tom today, tumor burden clearly and biomarker a to on excited to able looking also mutational following congratulations right announce and for that. I’m first being all, line the what scientific at to as able lung in been of and do to been First the cancer team science we’ve his

you highly FDA also coverage and X a to are coverage national be are FDA are appears was very of a for parallel TMB. recently It CMS they indication Medicare that commercially medically test approval, We that foundation And diagnostics. approved. reimbursement about it's pursuing in upon biomarker, companion know the and excited to predictive as determination recently as test

designed this patients. So, population, in the of you terms ALK- trial we’re size positive know we to design that clearly lung front-line and XXX, about of EGFR exclude very the excited very, cancer and of

the So, a the was I trial, the techniques. And to we well as methodologies, of techniques in to that rate number the surgical lot will confidence tested in were pathology the applies you XX% have with patients think improvements XX% TMB while as it alluded to trial. that that rise ascertainment

awareness team that today. there of I the very community oncology and improve lot educational also I we’re research the out we’re a helping side already quite focused been ready you hopeful and substantial efforts. would the would of Squibb lower translational where in a into that, physicians. is but is say that I when will Bristol-Myers and for that’s our on high say that much on has than educate it overtime say TMB continuing would there focusing So, this, academic at go of we’re gets degree and testing centers,

trial on approval, audiences course must And profile be the as ready you with TMB ongoing community larger have describe their at with on ones number mentioned. patients being the able looking be safety commercial an of partnership have We we having clinical will through in Opdivo dose and population. base a regulatory cancer so first to the great network, accessed. in after focus then help organization treated community icon and it large we important low of that’s to safety I-O pursue will a network our Yervoy line the being to lung a conducted oncology, And of of generate data drug, different inclusive a

Lastly, perspective, is very this I a event. positive from payer would say

Tom at and Scientific publish will to population around I we been clinicians and and be and plus presented be looking discretely a is hope I in have, that segment Opdivo. We payers the go a we low the exciting think Congress cancer Yervoy, able payers and as upcoming an will the patient think for both to first-line that benefits hope the way, better we U.S to from with Yervoy world this dose say, said, advent that market lung information have and thereafter. that

ramp. So, we excited very are commercial in about that Thanks

Thomas Lynch

XXX, meaningful, I mean think studies. lung coming of this number a importantly, eco highly part and set program, IDO think study said, X, will importantly, entire a our does more is elements this, study data have I chemo which when significant only confidence in we got and have combo is most via have of cancer then - f I just that clinically our which which not different Giovanni we increase XLA, probably like So, just statically remember our after you which something

So, finding that’s important an I think today.

looking I we overall OS think forward were and TMB at driven and thing as that’s the at I looking earlier, data about survival matures, point. we when we at and, second is them whether look that mentioned you and event will to asked broadly be know, the TMB sharing as you

data any second usually the know, seen study survival we as in its event you question driven not when look at is point. forward the at in your to early seeing is overall occur this required think final asked data. came that a I X, we extremely and again have part that about events And data overall of registrational. high you do as hurdle confidence stopping hitting and our we survival for down - question The look number the

able we this kind me this with to to I think we think it going as said lung are and data is patients, kind is information because States years, treated doctors big opportunity data United for of nicely. XX patients way cancer. earlier, they benefit it's and going this to going doctors really of non-small think in know the the to think lung to for, have and to asking the cell for about eager want to We the are which are the and in to regulators EU, change be cancer very think someone I put make as a difference share who's I the Murdo for we

Operator

you. Thank

go next from from comes ahead, line open. Citi, Andrew question your please Our Baum, now is

Andrew Baum

to you enemy Thank haven’t how questions XXX please. question from of great can the it number? that that of questions. decision and the be care? across are Obviously, migrate it populations GT-X much and consistency liquid is or that a which XXX by exactly of is be or the mono TMB congratulations basis. about congratulations. apparent then mind, the so, we And points or the the I to by operating that the again. data Three but that extent in in cut have thanks other going dark with you problematic the here. what the as three transferred quickly one, mean the of sense the quickly we TMB is Many can what is which mentioned addressed XX-day science Number expensive to seen a is arguably And indications. one And Do then turnaround to in adopt indication-by-indication of last this on to patient for and terms terms around along also off, Keytruda is we requires to friction, cutoff the continued in identifiable more can but persuading is identify terms and be to associated you relevance in more same there that, of migrate Tom's picked assets toxic educational indications with There need is in here TMB, low lines of for the friction up driven anything and education going chemo and firm clinicians which support. we therapy

Giovanni Caforio

Why don't Tom can and commercial with you start go?

Charlie Bancroft

Yeah, thanks Andrew.

the and think a expression market would we've while way lung a that to patients. in being first for biomarker is, been of line has view cancer able I my PD-LX select the stratify known perfect I approach

patients dose plus we've Now that about the lung think compelling opportunity line low first in of which an clinicians, payers dataset, think a cancer. for Opdivo us we really profile with that to able very large predictive establish And of and And high value as in redefine I biomarker this to been the result. TMB. is way a a Yervoy have

excited we're about that. So,

see allow where been very one good should these I how used. understand that occurring. other understand think and data say that think expression for think of role be centers play be are modalities the other there the options But of turnaround TMB will ascertainment. the into propagate to nature and still doing PD-LX compelling academic nature to testing are I treatment I predictive a patterns will and very testing presence time market. an to also well of with improvement community. compelling I is will closely us. working an acceleration It in of clinical when Medicine the and that and that will We're testing likely the them the Foundation a very TMB would and that I obviously partnership in times. establish And would profile, good tissue to a for us has turnaround say to logistics I with a very in currently and that time to physicians some think lead take

would going the process. we of test that so physician a a testing TMB our is to that for And test panel type goal in of in early hope as is our treating really establish primary decision making Although, a that available diagnosis patient occurs as it early that's treatment the forward. that

turnaround time not an be today we forward. hopefully impediment the as will So, go

question, Tom. For the liquid turn back to I'll it biopsy

Thomas Lynch

I off think incredibly translational would in one the Giovanni mentioned this. proud saying capability remarks approach of is we I things that, start as I'm and that of our by his how

that we segregate XXX, the that best what XX study Let We who looked What little gave and than a we've benefit XX, TMB. why we then looked to look of outcomes to points better we XX. look cut others. cutpoint of done have and study at at we at for of have study to lung of for we tumor mutational better are how burden we to different you cutoff And is XX. a able get response were a me of cancer. best as And sense give got to in number studies

Now This very it let's else. first a randomized trial. early stress I is this of in say, this to applied the the have is biomarker, of important report something understanding to

it was to this but that's and think perspective I did As prospective I tissue, important keep is analysis our mind. itself was remember, a a in we archival that using the analysis

have biomarkers. at Look how to in patients think other about you receptant breast with we to understand think cancer. how use I

You up file going understanding know the early X it or respect. I the is I amplification be not their and was issue that to XX really in XX companies investigators really I’ve at we’re XX number in across forever, and so became is and learn someday other I plus while seen that hope can in to numbers three you the we look that remain going investigators it and more, it going is two to number, be I absolutely it plus was is to key and data, as open the that sets might and promise think or data the process collaborating this other

might The the test indication with at is XXXX actually the test test might thing validated highly I be is this get validated number think the November was by the that indication. second on adjusted about itself for is time the XX by highly approved FDA. important, that’s and while it something

we’ll brings base which we much process and this do come promise blood-based good question point. for need that great was when for obviously diagnostic make work easier the that in So, them on the to there with blood and think patients. that. assays we assays to ask is I will think will while with is in FDA companion and us we last we I very And that work solid itself foundation the The indications, test feel about at think

look to yet, On haven’t you and closed. and better of hand, that the the other think working create have the coming in with tell findings companies that with our biomarkers at them. diagnostic looking imperative of And be of is XXX may we ways think I again, don’t today blood study I into can TMB I we’re and the urgency will increase better up we can base assessing forward of how insight quite TMB. number we What ways one

Operator

your now comes is Please question ahead, open. Chris line from next Schott from Our JPMorgan. go

Chris Schott

on for the much very thanks congrats questions data. Great, the and

of sort set kind data you of some to all-comer some Basically, sets here it's see to really combos as commercial adopt physicians landscape kind the on of TMB the from line. you here. that population front debate do this for hurdle TMB preferring, improved combo IO-chemo. about physicians what these other that to all Just and opportunity the When chemo hazard question of sets sets overall you competitive think think consider or there, this need those do you of data chemo in data IO-IO talked in versus sets see a consider ratios competitor we data relative about data out the here you

thinking there little that. a second on how I clarifying you guess to is potential about just a So comments just pathway earlier get think there. of do dynamics trying My OS to you’re you we’re I’m quarter sense, XXXX a the from XX arm Thanks so bit earlier the the lead filing much. read-out little understand XXXX data sure on study. file this than bit of filing.

Giovanni Caforio

I’ll then and start ask Murdo me jump Let in. to and Tom

survival given of a is regulatory the of So the Tom the of about as end data free is, but part with data the obviously very a was that TMB was we strength and this is primary the believe primary broad first respect to of important study core competitiveness, the disease. will I the of is heterogeneous authorities and we that set With think and mentioned what’s disease, here question said discuss all, study cancer so your the is times point mature that and the core progression that data lung of Tom ready. many has endpoint trial in very

know the there In in treated physicians is up setting, to it by of in the XX% hospital is XX% you community. and academic fact,

which strategy population what’s profiles TMB patient strategy. that biomarker strategy. So, also based helps always their identify treatment patients clear patient has Opdivo agents that different be to think identify the are both here, Opdivo in mind, population identifies the potential for really depending a it's to patients may of treatment likely that treatment our here, the plus not that be important respond respond on is, that Yervoy, benefit that, it are should from to data with not the actually which low is also in that the may data, plus with important, ability set data different be what’s it important the are right is competitive made more to combination But of and the patient very a that I I on treated it immuno-oncology is so of to and obvious going for with preferences our regiment define ability Because patients think options. patients that and Yervoy, is indicate a we’ll critical, physician here

there I market very most in treatment room strategies, is think the for evolve clearly data compelling. is but this So,

Murdo Gordon

lower XXX I We Giovanni, as is G-set who expressions, you eco market low have options. datasets, patients of of the the the to immunotherapy now. treating haven’t in in also the patients, we would - right Yeah, lot dataset, is on available. There the mentioned is what way lot PD-LX mind market of physicians terms treatment but questions the seen PD-LX know do who are XX a expressing lot thanks what on of still there not in a an options receiving

treatment over in of able and benefit forward. I With we the able developing clinical of two to in select out out very with will I think the I going given PD-LX and Giovanni makers treatments biomarker, and within portfolio. excited to that useful all program combination of where very TMB am use, understand inhibition, way rich Thomas very own in with treatment a that, broad for options clinicians exactly to the our XXX physicians of and I TMB and said, patients also Yervoy been a a this immune will have year and we that to The demonstrate PFS compelling more be in PDX and we have next also with as to described, for a answer but option what plus those able when we those that’s we checkpoint are trials think a population pleased be questions am trial are many there Opdivo that expression we be option all other half, years, able across low-dose and and clinical about TMB to look going to forward that help

Thomas Lynch

going as agencies, think those regulatory about to your being just I eco think this forward again one I how sharing with of to two, we eagerly that data answers question, are that that’s we those I the two think at I and look look comments Now and I proceed.

Operator

Bernstein. line comes is next Anderson, from Please Tim ahead, go you, from open. Thank the question your now

Tim Anderson

stay I filability on those, of this data. you. to Thank is want your just

in Bristol, know an have datasets you And I about sort commonly overtime think seen think you looking OXX predictor fabrication Bristol. on OS. at I a of biomarker. by is published least, different wasn’t big said of I TMB of that we if of Tom, PFS OS, understanding we’re is as wasn’t benefit. TMB So, what TMB much at certain analysis And including a was a of in And said, that but as an PFS companies, imperfect in -- there our if kind -- there early OS later there benefit

accept having struggling our to understanding, am just the your but essentially. is you without saying, still validated. that data, were I how for And it's biomarker So, FDA clarify at on could OS approval in maybe you're if this very see comments the we're very saying earlier data time early same

So Opdivo just of about put the in plus maybe out last point monotherapy context? have that's seen Yervoy the can in Opdivo the And data question technical is XXX you you that validation. the such

Thomas Lynch

So, you. Tim, thank

going look endpoints. those second and And two there And I just to those as meeting answer really at coprimary upcoming publishing over that, Let in the forward and the mentioned sharing the in and detail. quickly. secondary commenting can today, we of I medical those on in number question endpoints study we're are me

question clarify it understanding in measuring saying I'm What answer we're first that thank the again, earlier. which not in chance you your I'm we're how validity the early of of to to the saying to understanding So, in my TMB. question for Andrew's early measure to it.

could. not of and cutoff. has one question This to in was the in when their meaning, test going a being might meaningful you highly approved what by does to of question yet, And Andrew's cancer saying the, colorectal validated different Could that data at might test. And different or get a and might you're of other the When is as have TMB for sure studies I different ends FDA is of a different cancer be areas. test, more that be not of cutoff than different be as reproducible in terms TMB be. into were that's we'll we're another might XXX responding type So, have early tumor that's a test you cancer be in we're the vigor on the don't different it I of is it type We the is looking possible cancer it gastric up doing. this foundation scenario XXX. mentioned answer different, validated for test tumor that been we're not TMB, early pancreas that somebody's been it's possible

I So, important. that's think

versus question PFS second comes down OS. The to

data XXXX-XXXX this. have say not we mentioned What size any when as we do total the you patients. you patients drugs on I on about doctors as our this also as know in trial, not that own always, we things as have from have number as seen one I a with this on many the trial, almost was we OS on know, is at PFS many have you look before approved OS And XXX overall OS XXX you, was much of study comes, based been have data data before the robustness the is we fact of in And to I before approved And experience. nearly data. forward not Melanoma a of as Now PFS, always survival based to that comes And and comes setting. the often curiosity seeing Tim, frequently XXX PFS will data but it look study yet. this first

that particularly it's significant that clinically is meeting are case with IL not so, When matters. result this excellent there that think highly And compelling the why getting that's statistically we I for data a a IL large are which I therapy trial now therapy need. can in meaningful. who unmet have an there medical believe shows setting, out benefit And and from very for patients what's

Operator

Jefferies. Next question from comes go Holford from ahead. Please Jeffrey

Your now open. line is

Jeffrey Holford

the taking questions. for thanks Hi,

observe be that's quick PD-LX that now subgroup anything to be to about this don't remember look just analysis I going going greater this, and high like assume So there hormone we status could a than within to what spaces. node a here to and PD-LX drives more I perhaps you CheckMate-XXXX TMB I was know breast combo. receptor looking is burden are when something XX%. here. going three result stunning I It and a be as PD-LX at patient than we’re where like think cancer it be status. status these matrix really Perhaps X on maybe to physicians tumor points that if

some So on maybe comments that.

you combo tumor for Yervoy shouldn’t with no burden reason do chemo there mutation chemo, the rationale work triple works And this also acts of is then here? why questions Opdivo- Second and a that think in just data the think Keynote-XX not combo rationale G about the last, here. you. Do as file-ability strong approval well. file-ability few for Thank you president as that

Thomas Lynch

order. this little take a let’s So, by in bit

but so relationships PL-X at first in there the think understanding I a possibility your Jeff many this a to to data, potential So can between one, once looking interactions we have the very is that that a we looking and might that comment I do think other just TMB a population of data find and is benefit. we the might that, got at time interesting forward the with two status take think at about look I have look to that some help we

another in find to setting. echoed I of do and important earlier that really should what with are PDL-X the a biomarkers agents type might chemotherapy and not patients where IO good I And think say we well TMB, these experimental is combination imagine from or said as of treat benefit Giovanni at one Murdo is scenario which patients you who be all. therapy could a think thing

will So, the I at look at biomarkers among well the we enthusiasm that your biomarkers lung in at that for share two all between cancer. look interaction interaction looking the as

EMA with how rate look than Jeff we And at rationalizing FDA we final and getting question companies again will that might more of you color setting mentioned and strategy add scenarios then comment certainly discussions our a -- know we this used actual data the will in FDA the don’t I looking this sharing have that that with set TMB seen to relationships chemo. seeing don’t think potential XXX patients. just on as it significant setting. and is in with think comment say trials down or on Again, as that is forward other Second the whether point is forward and I hold of the file-ability, and them data in question approved. the I more the with the What the and patients to because look we will we yet do to to benefit haven’t that we be because highly sitting in the for you their we’re a different patients

Operator

you. Thank

open. is Umer coming Please question Evercore from ISI. ahead go Raffat Next now line your is

Umer Raffat

much is multiple thanks questions. so my asking for I taking Hi, I’ll multiple, figured John, everyone so ask else well. today as

went decision the and what you informed lets question TMB just have but is put changes changing not plan, part-XB what First, I guess how understand about that only like I the let’s of the specifically sets PFS to specific positives. main informed and stat the that first part-XA, OS pool wanted and guys these I

Just that, about curious one.

the I XX I was rolled the versus well. all megabit. high force you mono in if curves could mutations medicine noticed and still know foundation guys per as know as are is 'validated', mutations TMB XX CTLA seen TMB using Secondly, on you’ve mean just and that how is finally And combo I slides defines I flux, megabit. say curious per and then the you I granted high presumably explain PFS

megabit I only per because prior some to look question data been mutations regulatory of for in has XX ask versus doing my EMA mutations your per guess how this is reviews. and in does I chemo XX So, megabit XX combo versus plus

[indiscernible]. For Thank you.

Giovanni Caforio

So you Umer, for your thank questions.

So, I’ll the one, change start and plan, we first which step plan. change stat off how with we did do the the is why

-- emerging has improved. a lung so give -- incredibly the an developing quickly. lung biology And just way in of cancer our cancer to been of the has you this data And the sense, understanding

look noticed, hoping I guys you in were but setting. we and what the don’t know exactly XX we XX if So, didn’t that study hit for

is cancer, more and an to of biomarker. XXX turn might the - lung to differences a might study great it to look and three the and detail, of and was TMB looked the we a important okay. that, being data So, let’s be TMB at have upon population lung about study mutational with we excellent by study some other patient be it why, patients TMB said we out might about what detail on whole to of things marker, was us data -- And depth like gave it in data were our tumor been burden past different. able an looks to to on medicine this in XXX, do our and XX is we that’s that thing it, XX group with same And look Yervoy a in began generated important those at that and didn’t that that which work informing what at translational then cancer while look about based emerging came great be and understand and and that we patients sequencing practice so how of were doing understand

to the change do, double was study statistical That able give look - PLX OS able stat at the group. which size us to the to to trial. enable defined optionality still plan remember to be us, look in us to XA ability while to gives marker the important that we patient the of us we be look at like to of nearly part TMB, So, a preserving size, a at of give to the really

we how for there. background the think I got really, that’s So

and critical TMB seen think foundation important X and And benefit what data I we have distinguished XX, we foundation What an outcome. all those and variation is a the found datasets, in prospectively between clearly able I you the about then is when the to what in as endpoint that gotten we been setting, think using patient validated question across. we the when sample, the about XX, told is three we well, the have population the regarding between very are Yervoy this X being you high, haven't And a patient analyze XXX, tell look can’t using XX XX, to is can at to XX say point, do do was all really believe TA at is is, that and just of those CTLA we lung point. the happens going cancer, assay all look I at in we in might. this show this I learn from so might happens well. say you can patients I what story, to I your look questions, this are XX XX XX, say, patients to tell part tissue, our our where Where cart have that that better, far, got might interesting, we we have with Yervoy result. X who this X at think the excellent yet who I are were high And able we more things they don’t even also time. again, last

Operator

Thank you.

now Meacham, open. line Barclays. person is ahead, Please your go Geoff is next from So,

Geoffrey Meacham

Hey in the point, ITT and the Tom doing logical had an path morning more more I other you PFS I you guess step you. OFR think this lung, important that, question. as that overall we guys, are you think the tumor Part data what B types A basis and tumor indications, is the XXX, next Part on couple. are not just How on Thank work then a our and you haven’t and approval do do segment. mature. On have have you TMB, do And or or good you XA the what for thanks think types activity. at in and beyond done guys you your already for think, formal IL seen TMB

Charlie Bancroft

Jeff.

first on the comment your first question. Just

measuring TMB XXX are in we over mentioned, As Tom trials.

of one across of role started the clinical stratifying patient in And in evolves, of study looking the we more learn design. which trials program we in lines therapy. TMB much We're of TMB You will status included types remember lung as that's selecting will populations for was about first tumors cancer. multiple of our TMB outside [indiscernible] the obviously development that at

Thomas Lynch

And XXX. on Jeff question the for

things looked of what the on emphasize what I at yet. think that couple I want to we we have now haven't

group a of also histology. with are regardless in PD-LX TMB And these of remember high patients expression. across So,

The squamous survival disease and working biology the you'll What we're seeing other and keep PD-LX both following overall this this in other as forward addition back that Opdivo data cancer, fact going and data of emerge including keep not to in And there we our So, look now that that two our is keep we from is dataset. Yervoy lot as improve a of is, would that lung say going the but you did to And low early that selected don't that we in outcome. having setting. sure We still to agents that's with PFS Again, a really to from understanding I and studies was have investigators there circumstance coming answer in group. non-squamous. dose data. road. down in haven't learning the and that survival to well, And just reported just yet. can more as there we're from love data we the not I'm to well. about much improve have the I'd

Operator

from Credit go Suisse. Next question comes Divan from ahead. Vamil Please

line now open. is Your

Vamil Divan

much Great. Thanks for my questions. very taking

Just two more on XXX.

following So on think up just I comments. prior

why was also second I'm did not as plan analysis one population. change you very stopping data now now, that you the just but, you clarify PD-LX CT your why driver about to that stats TMB. decided Thanks. was are was. making OS as the end as PFS. that then can't there stick still And I'm know why continuing finished. way for interim and curious plan can to mentioned that So, TMB on for And be When you talk X. and Part for Why is are or positive why OS part points you not one, that that now in solid in was one. always benefit decision that XB the is Part look we to as you've to you're wondering why stopping the not made it and that data, something with comments the maybe the you changes, you I do the the analysis OS

Giovanni Caforio

things them. say your So, Vamil for thank couple I'd to of you answer questions.

part this is that's TMB is from negative, first fiscal question then Opdivo second PD-LX as in is high analysis. we The acting which there design regardless that TMB XB And PD-LX a broad is, across way we design were patients of question patients analysis. the thing X Part of used because group their we in finished XB status. the but chemo Part the And the

point. PFS that couple value it's look questions and of to we at have for haven’t will forward so overall this this I to look a data change we entirely one we things PD-LX why do overall patient on, but and of data survival do the of the from seen important Because one it on we TMB and earlier have think versus survival how data your the reported TMB OS seeing TMB is first just on reflected of wanted part so at large, study again We data and we for it? that optionality the just not question to in population. change seen the this question that's see OS thing and your people asked we the that

data overall that for waiting same the we We’re to At a preserved in ability population. survival set PDL-X have mature. to at time, look this

of So, important has get parts And X-B study-XXX I part all XXX the think that three points the those was and across. smallest of really are to part-X patients. almost

about be the of that chemo part-X wondering will in study. answered you’re with question Opdivo if our So,

Operator

Thank you.

is UBS. your go Marc now line is Please open. question Goodman Next from ahead,

Marc Goodman

Yes, couple.

have the remind -- case confident year. and you about And the try sales that So you’ll pretty OS good you financial to first we that that in and are so what guys it you that from. OS. giving key where confidence are and differences hit on Why I of Opdivo not comes when describe about just more want but us breakdown PFS this quarter OXX hit of all, on understand feel can us second each on you then

FGF did begin have third off if could will what you looking that Thanks. signed you as will endpoints So, been I we’ve know when you do you be for then Phase and on mentioned you there? talk FDA, you helpful. that quarter, for the to should X, waiting, And be the actually

Giovanni Caforio

me let maybe. Mark start So, with the FGS-XX

treatment to was of that one that FDA to we our As the FDA set in discussed we in phase with we for we were had you discussed is the know the at post fact development post the the conversation we’ve phase-X of start we next a veins with FGS-XX study original that now. have had biopsy doses, and go so right we’ll a study we ahead included large not of different to biopsies starting be the decided study into looking with move that before treatment is

Thomas Lynch

by it a pre-specified was about we to like was presented retrospective XXX PFS, was. It I generate cross hypotheses ACR based amount OXX again quickly I a a There TMB that we assume that address generating predefined year remember used is the and prospective question over look talking last the of you did, lot So in in think separate not at that data. PFS just analysis OXX OXX setting. that to on showed you’re on but the

Murdo Gordon

question the Yeah, thanks for Mark.

all particularly you continue we lungs label worldwide after lung, and enjoy we type For Opdivo first But US get XX% of you give a business sales by of XX% of bit in in because to because physician to numbers establish earlier in line in can leading to cancer, XX% obviously get we about and Japan X like markets HCC the the when you lung have adjuvant to that’s you our XX then tumor of currently I the a very because give we and XX I’ll XX% In strong and give then in by this to usage number, lung and strength go lung between off that the squamous. U.S. ranges so, update from is XX% lung early XX% able We’ve in just claims should major think ex-US roughly estimates now cancer around its approvals hard because to indications neck I’ll access and strength melanoma. specific leading in probably about to have particularly give X others and is of XX got of performance there and I all a worldwide, of been in point you melanoma, that’s there as very that. XX reason outside head kind types. renal, to the through tumor approval, markets France, to the

Operator

is America, Lynch. open. go Certainly, from Bank ahead, of Merrill line last question Please is your Jason Gerberry now

Jason Gerberry

So XXX. question just quick regulatory on one

other light XQ they just -- secondary target the of you drive thought I favorable sub-population European Thanks. in Merck’s are would as to just comment approval, different TMB a their endpoints you that PD-LX is get prevalent enabled. high So the in after. going earlier provide that, approval in to to negative TMB in then gain needing for or one co-primary question, need how approval the that, full clarification the of in wanted is endpoint about registration be And OS high population can proportion would in just and patients? OS of

Giovanni Caforio

me let answer maybe question. that Jason just,

survival regulatory the study end free the to progression forward going study with interactions, look not comment stress are more met the primary want on authorities its part and to that just point the our I point discussing around of that We end but the regulatory TMB to is world. primary in and we

the obviously data to and together we at have be said Thomas it number just there that significant are think PD-LX. forward that that a secondary I topline presenting and included regardless study we mentioned PD-LX analysis look across the the of we other looked analysis received that, earlier we conducting so data, have expression as of spectrum future patients full of meeting, with at TMB a will

thank everybody the everybody. at have we at I and carrier, a future to advancing oncology, just the my a a XXXX opportunities MSR great we I reaffirm And that like have in are scientific in cancer research me Thank with I was are during in speed, forefront participating close multiple the I today you time that year call. am results for which today let many, for time. in the to build remember shared and can’t at many in that and So, enthusiasm experiencing we my your closing proud the we and incredible be We Thanks strong for in in of beyond. pursuing confident very advances. and the Appreciate company the very XXXX am I you. years had

Operator

you. Thank

that So, Thank you and gentlemen now Bristol disconnect. your quarter may participation, fourth Myers fiscal you today’s XXXX ladies call. conclude for conference results

Bristol-Myers Squibb (BMY) 5 Feb 182017 Q4 Earnings call transcript