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Bristol-Myers Squibb (BMY)

Participants
Giovanni Caforio Board Chair and Chief Executive Officer
Tim Power Vice President Investor Relations
David Elkins Chief Financial Officer
Chris Boerner Chief Commercialization Officer
Samit Hirawat Chief Medical Officer and Head of Global Drug Development
Geoff Meacham Bank of America
Seamus Fernandez Guggenheim
Chris Schott JP Morgan
Tim Anderson Wolfe Research
Luisa Hector Berenberg
Andrew Baum Citi
Carter Gould Barclays
Ronny Gal Bernstein
Matthew Harrison Morgan Stanley
Steve Scala Cowen
Dane Leone Raymond James
Matt Phipps William Blair
Call transcript
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Operator

Good day and welcome to the Bristol Myers Squibb 2021 Third Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President Investor Relations. Please go ahead, sir.

Tim Power

morning, good and Christina everyone. Thanks, us Thanks earnings third XXXX our for joining call. quarter for

this remarks Officer, Head David Development. Joining our with Boerner, Officer me morning me prepared and are call Hirawat, and Financial Also Chris Executive our for Chief Medical today's Board Chief are Drug Chief Officer, Samit our of and Commercialization Global Elkins, our Officer. with and Chair Caforio, Giovanni Chief

to follow note started, you those You'll forward-looking we can remarks. Giovanni's to posted I our get with and bms.com along But that slides read statements. we and David use before will

During constitute the Forward-looking about today's by materially Company's that results Actual and indicated may differ prospects make call, statements. we from statements. future Forward-looking statements those plans these

estimates various the as important future discussed and GAAP bms.com. We'll statements to I'll of Giovanni. financial to non-GAAP adjusted it specifically our These Forward-looking measures, should those focus including as Forward-looking items. disclaim Company's statements, financial estimates any of upon our relied filings. available representing result estimates of change. in are most represent also factors, comments that, over our not are any a our certain the comparable of to on these which measures specified Reconciliations And non-GAAP as with today We measures update at SEC As dates. exclude to obligation be for hand even

Giovanni Caforio

that I all everyone. Thank well. And hope you're morning you, good Tim. doing

assets fixed of In-Line REVLIMID, with our and quarter, of our I-O In Relatlimab performance and in we plus the accepted for important Opdivo melanoma. nivo of and the in data our products, we perspective, proud promising $X, demand treatment a with EPS priority non-GAAP financial advanced Franchise the patients or sales pipeline the progressing with we're for and an and our good we Eliquis. additional delivered driven the execution dose the have the growth commercial growth growth our and progress Now commercial turning metastatic sustained review for for XX% X. dropped a to pipeline. of In solid for most who and readouts our quarter launch third growth. how by us to reported Slide future. I-O I'm I'm solid for with including is on products of the pleased in unresectable XX% development the very our encouraged sales rest performance From they R&D, teams third I'm U.S., Opdivo, strong report This 'XX XX.X our for good of billion horizon. of of results and for the position by respectively. mechanism

and a range. guidance we are the EPS lower As reaffirming result, raising non-GAAP our guidance revenue of end our

to strategy we is strong Our disciplined on external in internal and capital focused continue and allocation balance sheet investing a pursue innovation opportunities.

value IP, front, Appeals in with existing with confirms the until pleased the IP Court behind the pleased our the by are I'm of Federal IP exclusivity the decision the settlements. innovation. protecting we On XXXX holding up the extremely our quarter. belief for and U.S. the Eliquis's Overall, providing progress science its Eliquis under decision Circuit This in underlying and the of

for in milestones to prior on making start of won't in hard demonstrated successfully the highlights Turning call details start in X differentiated has Deucravacitinib. portfolio. worked more his remarks. I Deucrava Phase-X this we scorecard us to want But has profile studies At details. a with renew David accomplishments go I'll were The through compelling slide A the provide I here. few the out we're included will proud on have and to deliver the slide treatment and our the including board. our psoriatic choice number all a program. I a so across X. across where out And of important that team would with I'm order scorecard to thought number we execution the with laid potential is an the initiated oral arthritis, important year, be progress of significant indications, in and already of psoriasis. asset Phase-X a

Although we for another colitis, disease. proof-of-concept Phase-X in achieve did committed Lupus other We're disease, in ulcerative as study and for to in Program inflammatory Crohn's promising Deucravacitinib bowel mediated ulcerative as a advancing our immune well not Including colitis. Clinical diseases. study

of and have to cell strength our excited data a look for We're from of in the data American to to progress presenting forward data, undergoing in with looking for great therapy the study In at also make X a to knee set VTE And broader to patients. the replacement cell potential in Breyanzi. few are second prevention forward which patients franchise the vaccine, reach the transformed ASH. conference franchise Heart presenting Phase total for at we Association first we weeks. continue our this DLBCL We therapy line, enable

at so to strength oral Looking I for track to our what required we renew on portfolio. that the are execution am us far, confident is of deliver

Slide Moving Myers Squibb. the years has X X. Bristol It been new to formed since we

on have I reflect time, this already we made As progress. great

integration, are and face into what products most a we iberdomide. strong milvexian in Company's promise continuing of When our Knowing with progress the dataset our are launches us. our exclusivity years, products the doing our coming launch generation of I'm and the including and for multiple demand years, assets, to for on for important pipeline our of X next we recognize We losses well particularly pleased future. our last We the pipeline, a growth, fronts. broadening that to on as do, the is value out importantly, executing our reflect on advance on set both for on well drivers continuing the foundation strong I delivering delivering and such we I newly-launched of see and establishing

X in franchises with ever diversified Company and before, the continue invest to than flexibility durable Our today innovation. financial more to is

will the investor business we announced, an forward over made have with closing, global pipeline, to progress further thank Company's X strategy, this XX I David. who maintained I'll hosting recently we to turn And event look to like significant over opportunities. that, New delivering us. and our we David would our in the through hope on years, the November progress be teams in patients I meeting you and discuss will through City have period. I the to last York you join on review for and financials. the it to walk focus As

David Elkins

another as third-quarter versus revenues we today. joining Increased but you, for demand primarily prior portfolio. Thank due you growing quarter call our Starting to product on our had top-line our strong year, new and with double-digits as yet Giovanni, our for performance all with brands, Slide well thank demand. in-line X,

So on prior light expected up fourth that strongly sales strong XX% growth versus occurs prior year, global In by prescription driven third year. shed in with growth and gap our perform quarters usual, continues in X. liability be let and market Sequentially, total very year. to by continues some last Eliquis as of of class Slide to U.S., volumes. product sales XX% me XX% with on coverage impacted a performance, with share Demand new-to-brand year. the were the each some large starting growth the Eliquis versus versus grew sales gains

execution prescription - share strong new-to-brand XX% to overall to and to with a grow. rank prior grew Eliquis' primarily continue remain sales versus share room growth. Shares all OAC additional around in continue due the expect total Eliquis' further translate class. to within number year growing to to to increase key as the really We Internationally, to one expect multiple pleased growth and with across geographies world We demand. markets grow continues

Slide XX. moving Now performance Opdivo to on

the And had for X%, cancer the our sales the primarily uptake brand, first-line versus in other work We are inventory million demand sales prior by new sequentially, growth of year. of and launches In X% U.S. with we second X% offset versus build XX in pleased growth down the noted driven lung last year. by quarter. in we momentum with grew this year, was a which continued multiple

We've newer to quarter Outside indications U.S. last access versus by primarily as year. with XX% in we positions was expanded Turkey teams sales Growth Latin pleased and with execute America, strong in another strong had commercial continued Russia. and melanoma retained driven indications. are Our very up indications the the our well. of and renal and demand such new core performance for

expansion as in high. continue launches, further other first-line now read the is Japan We key including approvals to Germany from launches growth ongoing contribute opportunities future These lung May new and that of launches expected on years, to in see of our for strong trials gastric in and next momentum markets. update our the clinical discussions 's few cancer, with launches, first-line esophageal reimbursement internationally. Opdivo as are Based to recent out current with the year, growth together pricing well cancer renal continued and positive esophageal on promise from over next we'll from potential and

to use sales and triple primarily XX, treatment therapies demand and globally, continued driven based by in portfolio was triple XX% In-Line lines. Turning increasing demand our driven global myeloma XX% on up Pomalyst by for multiple based REVLIMID earlier Slide therapies for were duration. up

quarter. we're on on $X.X generate billion us lifecycle. our pleased Now giving very products XXX This to business renewing run diversified already that XX, million we sales our which is with portfolio to Slide to way products earlier new of close continue our are confidence third rate, that great be products annualizing the moving new with in to their much our in new

the We're recommends X supports as up demand treat U.S. a instead response to to of XX% their driven million new which generated update X XX by encouraged patients, in year. recent XX This patients So the treatment primarily previously with weeks. weeks the well that refractory to very monitor ESA in sales build. potentially by in XXX let's Reblozyl, growth sooner quarter, of continued and now NCCN evaluating versus in third as was million journey. recommended need guideline at MDS $XX $XX million a the earlier inventory ESA start prior strong to the Sales

ensuring focused appropriate the Additionally, one U.S., impacted sustained in Sales received remain strong to Reblozyl the is launched. Germany. the were price year review, for launch be by on continues usual dose countries in most after benefit. Outside uptake we they where

in additional the more We to in expect reimbursement and countries for XXXX discussions, pending drive in to growth the in and Italy brand. launch QX Netherlands

of expect to to this to be revenues exceed similar months quarter our supply, sales Abecma T, cell BCMA in million million in to generate Abecma, Remember our XQ and quarter that XX versus We X.X third remains QX largely reflects having mid-May, revenues XX Demand we launched the full sales. quarter. a therapies, quarter only in of robust. for of Breyanzi. first-in-class CAR so second Demand consisted continues Moving performance the and QX.

to to Breyanzi moving pleased CDXX lymphoma to XX million quarter. ASH Now clinically B-cell sales extremely versus due in and profile. look second-line to Large at patient were XX in the earlier line forward meaningful best-in-class the Breyanzi, million PFS data patients data have to T quarter physicians our XXXX. We're this treatment increased presenting the CAR demand bringing in prior in Sales and recognizing with

Zeposia, in prescriptions. inventory build of by to The of were XX Turning in continues written launch, launch quarter multiple million driven terms the SXP one-time in Zeposia progress remains MS global the well, sclerosis the where U.S. to revenues choice and

to SXP focus in only but oral MS. the also as choice, not the choice treatment continue of establishing We Zeposia on of

growth by UC trailers launch June. is and of launch also the the Our We're encouraged well initial the new uptake since in in U.S.. in in progressing number

building And making establishing received just Europe. have as broadening volume, look this access demand also living time. medicine, biologic-like soon opinion oral possible. pleased as with to while Zeposia very on for focus in CHMP We're available patients Our to positive forward to is over UC

XX progress quarter, establishing prior the AML making patients. driven demand as increased quarter. primarily first-line of generated million sales well as by inventory maintenance and we're Onureg Lastly, and versus Onureg build in on

the focus and to continue shaping adherence. We maintenance segment new adoption patient on and increasing

quarter. through to increase prior already a let few margin year Operating due strong our covered versus key for P&L to other expenses XX. so attention non-GAAP walk the slide items. payments. Gross We've quarter you line our primarily me over lower were COVID prior MS&A -launch sales royalty recovery, due Now of let's on did turn slightly higher to investment investments than last in pre versus softness the shifted to also year, to MS&A due our and R&D particularly that fourth due supporting but experience quarter have activities. launch some timing to the in

XX.X% Rate XX% was Our Effective earnings Tax primarily mix. EPS driven Overall, year-over-year. by of increased non-GAAP

marketable Now almost moving Sheet operations and liquidity billion securities, Balance strong cash flow capital XX, from of on with the remains quarter. $XX to in in our and X.X and position billion cash a our allocation Slide strong

unchanged. allocation priorities remain capital Our

to allocation. flexibility financial a We support have significant capital balanced to approach

to renew We've paying down in business are our priorities deals through as assets. and capital portfolio bringing development a returning to to shareholders. year, diversify Company. top our Our priority development, continue a business and this Business differentiated several early-stage debt, development executed leading innovation-based remains

down paid X year-to-date, strong in to maintaining rating. investment-grade are have We committed debt and billion our

shareholders, board share and returning repurchases. dividend approval we're it committed opportunistic growing subject As to our about to capital relates remain to

We have of billion authorization remaining billion we have and already purchased our currently to-date, X X.X shares program. in approximately

on the XX, and performance lower of strong end based we in guidance. Slide non-GAAP the Now, the quarter, raising sales turning to on reaffirming our EPS our guidance full-year

XX%. be at higher to revenues We our continue to approximately the to and of end increase guidance margin gross expect

R&D guidance the year. Moving we and are for to operating MS&A our maintaining expenses,

expecting we shifted investments by in the higher As I earlier, due timing mentioned that expenses quarter. fourth MS&A quarter of are to

providing the This our back progress. updating with execute we're and around employees dedication XX.X% and had remarkable to to that, rate achieved approximately our turn primarily our against passion of earnings it to our tax you quarter been over well will the world, and and I'm I due renew look Giovanni to another I performance. plans Company, our our not performance now Q&A. All-in-all, portfolio. Additionally, mix. can We on and for With future without guidance continue to diversify Tim updates for and to the forward pleased

Giovanni Caforio

please? we our go first Christina, question to can David. Thanks

Operator

We'll Thank Instruction]. first you. take [Operator of question Meacham Bank America. with our from Geoff Yes.

Geoff Meacham

the pretty quarter. I on was question ask Hey congrats guys, wanted taking just good. launches, new and a for Abecma thanks on good to the launch the

XXXX viral impact for Just this give seeing much and us is the manufacturing. also of still are from that that us bolus with And helped how you underlying sense then vector the still versus demand of the a -- patients second you you do view question just Thank to into very others. Opdivo. And more how was be point tipping could going indications a what It much. on flat of sequentially? respect with versus

Giovanni Caforio

Geoff. Thanks This questions. the you, Thank Giovanni. for is

marketplace number I whether and ask the the option start question comments then had cell that over physicians and the this at is treatments your remember more the just confirms look with have look were and very and of so right obviously uptake and in discussions safety I'm therapy past commitment the our and really than think treatments given the to many we of I efficacy the have a increased payer this dynamics It of couple a There that about payers the to with therapies. the questions. just the as beyond both for there to provide coverage profile, fast belief both therapy cell say, had of right past, recognized. resolved, medium and where tremendous I willingness to that back of willingness to me grow term you'll answer that reassured prescribe would been portfolio. Chris concerns Let being therapy of the we've a really at made an the marketplace, wanted about broad drive in market cell those say commercial Chris? is time. Abecma I'll answer would step significantly potential a and we've will in Chris must the would modality with long Breyanzi. with we've And I when experience in

Chris Boerner

So for the questions, Jeff. thanks

the for some underlying product nice demand a bolus both both numbers, for these with strong, or use the majority in or of increase with to products. in accounts of both both we're so Let There activated We We're we cell very that very accounts the really therapy, still Breyanzi. me one for of Abecma have products. and very performance was but reflected demand is execution In now these Abecma start the plan saw Breyanzi. for those the quarter with looks with pleased cell And very the been over have imminently happy true products. both across same XX products. of have therapy the commercial that been

be commercial overall, continues would to I say good. very So the performance

demand to next are roughly seeing constraints supply marketplace going focused the of we remarks, mean, are just with opportunity QX, very We the front constraints. the we stepping the happy solid through better important the are, year of anticipated being you strong mentioned in were strong again, been inventory growth Abecma. David therapy we first-line As the line we Giovanni time coming is here, very on performance we similar are approval from what as a and be quarter have that fourth it quarter in a With Opdivo, had quarter We has we growth some tumors to But, impacting are Franchise. actively growth into the double-digit saw for second mentioned, what get solid we've Notably the mainly that while uptake anticipate in for same in near much with his cancer. continue And cancer, that quarter. gastric a the already, for sales we're at April, relative as position time of year. we've cancer, a dynamics out really the mentioned function as back, half David lung to the flat, in those year. supply growth coming as seen to to going of And I-O is had the we Abecma cell course, drive the and I-O we managing cell on that managing And to vector in do in where third I of here. saw since very nice What very on in relative key build quarter-over-quarter. to continuing we're of growth end growth expectations. second was, that the quarter. in last And position same to and stay was mentioned, in respect to nice the the that strong was see into confirms QX renal know, medium-term seen last very as in quarter. in sales and

into importantly, So we for were year, very but overall, growth the Opdivo not confident going back, if step only this in momentum you the continued 'XX.

Giovanni Caforio

Thanks, Chris. the please? next Christina, we go could question, to

Operator

question with Yes. I'll take Fernandez Guggenheim Seamus next from our

Seamus Fernandez

the Great, question. thanks for

is get one I bit sense. first I just see surprised as So It Deucravacitinib. don't Deucravacitinib a on was listed better little wanted that -- have to a filed just of to seems yet. we

limitations it I just Are Just critical the the waiting the in not what as filing? opportunity just get The of succeed plan FDA Bristol achieve our is added development really a that be better may think dose that of for part IT-XD new the for are. don't It's is being wanted ulcerative Deucravacitinib most about understanding second unless question understanding added, to data pushed. in believes the what to there Deucravacitinib, acceptance colitis. fact may or that the perhaps you know plan. necessary or to we or the of is And simply that really is,

acting the having as formulation have SXPX would Then that watching BTK any inhibitor, is that so a Thanks. just of we XXXX And should just if you Between long data in in final that call your Phase very X, you maybe inhibitor, these for? quickly. Bristol the MKX pursuing. question be a wondering something out

Giovanni Caforio

Seamus. you, Thank

Let answer questions. me ask Samit your to

Samit Hirawat

for questions. Sure. your Thank you

reiterating and it the one the just oral best patients in first psoriasis. therapy potential differentiates me which On choice it confidence of in Deucrava, by a the start data future our for with establishes on as let

on the but accepted, been public after don't as for very filing, you certainly it know, we file, make out file do we the of terms have the when well In we when we comment has validated, filed indication.

in time certainly before. anticipate do that, as will we But we aware patients of we as everyone when half the we aware comes. XXXX, having and medicine you said have bringing said make So to the second hear

we'll ulcerative You're in We than And is of what other are in and higher not the are doses we being see we general, confidential reasons reasons. X colitis, On sense PK, for terms as what this will right -- on for well the that colitis, to disease competitive as exactly the seen from avenues but these in obviously the looking a outcomes test is IBD well. for psoriasis. in be the intent that for Crohn's those to shared define at molecules required looking But at reason of or And in impact doses. out pursued ways in all those ulcerative and to disease, times to to ongoing proof-of-concept pursuing the only ulcerative the further going trials, question X have and be the follow that PD not the dose continue we've colitis.

additional terms MKX, the In of BTK data, those trials SXPX, are ongoing.

Phase trial these know, multiple indications autoimmune same are BTK in XB XA, in you As have SXPX in pursued the Phase being also. we space, in the settings where the

example, being clinical as for is of evolving. you'll disease, it data. for Crohn's data in say Additional or not, soon done work Zeposia 'XX for the that can't certainly see outcomes I as for evolution make we'll MKX these available the but have data we as well, and in

Giovanni Caforio

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

Operator

from our take Schott Chris question we'll Morgan. next Yes, with JP

Chris Schott

Great. Thanks much. so

rate a eroding And something any I thinking we all again, there's I on than It reasonable appreciated. second have for one. that down the just any things think you're I debate and question time, like color Xst lot dynamics in international of Is specifically much of businesses the for you worse just or both on year the much the the Revlimid you're next over the one questions provide but be international U.S. is May a business. guidance 'XX. bigger you're then the facing picture and two it me. just that. the low, Is XX% on thing year. next better know about But been for of rate color of or erosion given side erosion of there think Just can would -- giving of maybe not

the steadily and but lead this remains that's stock a I aggressive to a that been year. in BD LOEs, at And portfolio the that's capital, here, a You've if more that at guess streak or some on longer-term you've had -- of these step-up point maybe later rebuilding of some look concerned even deployment larger repo. stock under a performed does the would stage do your about more you you very sharing look what's what much. of starting I'm think and How Thanks share going aggressive business think at of disconnect deals, fundamentally with or the address sense you when between as direction other happened your to that? with price. your

Giovanni Caforio

Thank you, Chris.

your take me here, questions Let Giovanni.

changed of all, has on year. just reiterate see said next what we there let So nothing before generic and Revlimid me happening and we've first what entries,

year, our it to what always begin generic consistent entries And that. EX-U.S.. we generic at next fairly will and it in a expect preparing limited with we're the So That's changed, we our the has REVLIMID volume U.S.. for not in has been competition see understanding, for see filings to been time, has same clear

growth Company, And we would and understanding think when to we we products the next In can in-line the Company Company were is if and the and which of And that the Eliquis, able conviction driven double-digit for continue perspective, the for Revlimid the the by provided the combined our through and to think the we launch Opdivo the erosion. strong XXXX. fact, at for And than over total of time that loss clearly loss say of right namely, Revlimid that with belief single-digit combination low-to-mid articulated brands, then that which that remember in year is is low we articulated thing Company second uptake during our exclusivity to of U.S. exclusivity the expect would proving reflecting internationally and our we have more continuing we've I strong of grow about of Morgan, our be is obviously JP on business The to happening that how offset grow of I beginning period we like you from Pomalyst. Revlimid the really

What for going to I'm year, exactly guidance what opportunity erosion will have an think and able So grow more that applies when of well. eventually to I is our about talk per you provide not that percentage share and year. as perspective to to next I we that earnings next belief give sales we remains for tend can our year to a strong definitely and this you the we're

so there. really changed nothing And has

And tremendous financial all, as think Now, what we we're that our with And respect capital. we about tremendous before, late-stage the the same many time, said priority to we as us is think LOEs, be always our launches continues strategy BD. think And growth. believe at consistently allocation will and I of capital have And be case, I David time in year-to-date, to think in your we've history at pipeline. repurchases we dividend, our do flexibility increased years. that accelerate as the a we to going portfolio we that speaks that because to well. has be I've reached second new very said. will have seen - our continue as our we've several We've be the the of is the have for look done said business David First renew looking first priorities some for of to to where maximize that repurchased face the have And dividend double-digit opportunities balanced, we development for a to share billion. obviously, now multiple years. that have over - to last at have very, we've we X.X where rapidly are in mentioned, that capital portfolio allocating a we medicines to opportunities time same question also At of I couple about our as priority disciplined executing deploy we last the as a evolving the potential,

time I the existing at to can tell of obviously, well. course, we have year. understand believe this right to an have I we'll and authorization portfolio, that. same But at X plan another really continue look on well as executing on LOEs, that we billion And do focus We make to that that the for you as continue financial our moves the flexibility are to tremendous a we renew to

Tim Power

Christina, next question, can our go to please? we

Operator

from Wolfe Anderson question Tim next Our Research. with

Tim Anderson

thank tumor new quite XXXX the a I was have for And when designation LAG-X, XXXX survival question they questions. didn't got the new why trials why awarded in Bristol different in clear seeing on signal survival yet, do you data update hand can like us There's with I of your Well, confidence lots a TIGIT, on that lots trials your not -- development approval on when it you on previously, will terms at and A answer. all from molecule already of gating package that pushed just a here. expect isn't was here factor. launch. what look But we I melanoma Mavacamten, wondering same at in in program you've And you pretty this a And question, review you. understand once. that Roche melanoma it breakthrough therapy and you submitted? standard types? of only data the for then XXXX, expected can quarter, is the we're couple of I'm there second that asked looks in tumors registrational overall into last

get you additional we confident a a approvable there want they'll data re-ask at date, have you'll an the or CRO? I'm is here, it are that potential drug So PDUFA gonna and

Giovanni Caforio

Sure. you, Thank Tim.

ask me LAG-X your answer questions, both of and Mavacamten. Samit Let to

Samit Hirawat

Sure. Thank you, Tim.

dependent to you data overall it. them to make medical share the on once events. I'll survival but follow data going we'll the conference, LAG-X, For aware the We're our and available of through is certainly course, continue of

exactly to we'll I-O remember have for perspective? time. We in more than of watch becomes that are be though, ratios important Yes. at the be those going tell I From that. that to share therapies, hazard to development program curve cannot would this that And available. and the shape when to you what a we're the timing continue out going

March for have out read of XXXX. we The a we date first submitted, line study PDUFA melanoma

melanoma the have trial We time. adjuvant initiated at this in

to cell X We of year. at as X a know, later in this have early long plans remaining year we initiate the cancer next proof-of-concept rowing and Likely, a And year randomized study carcinoma lung for or this randomized has trials have didn't we history end any a non-small scarred a or ongoing had phase trial on a where as generation. time parul you have in data. phase

forward. So proof-of-concept that we to to we give the that going ongoing are one And believe data we're will have following has trials go strong. be that us to that ensure that the

there tumor if digit lung proof-of-concept in is a terms tumor type a micro the you in is cancer, and different that cell and non-small For value environment. recall, different of

and to explore. to perspective we certainly 'll types for in are posted LAG-X put have tumor the well. that we And program we that scientific keep data the you as judge new So as types tumor new look added if in

well from as efficacy are the mavacamten, we certainly perspective, we explorer have as trials, the data safety perspective. from For the comfortable with that

January of next have date for We year. a PDUFA

what but or We at drugs. unusual FDA other any continue what have be usual Mavacamten engage the terms data for And But in will any will certainly required. and to additional we outcomes decisions how agency made from them. be the heard questions is don't with forth to the be would answering by comment and that as We the in not continues. is filing, as as ultimate back the we not look of

Giovanni Caforio

question can Christina, the to go we please? next

Operator

Okay.

Luisa question Our next from Berenberg. Hector with

Luisa Hector

check where wanted whether And this are whether we you you from well, costs you. the end generic XXXX about in us could on Thank maybe just QX. reasons impact this with to and Where questions. your those Deucravacitinib update my phasing into cost-savings? plan sales for you year. marketing is started I market of key dermatology of also increment be And you for the given what hiring to the Hello, items. kind your you of could QX thank or the various already, these, phasing as think the by now of see on to the post have

Giovanni Caforio

investments commercial launch. the start preparation Chris then on Let's synergies. Deucrava in and for with David

Chris Boerner

Sure. Thanks question. for the

actually well have We and for about that pulling way team as commercial quality are The teams together teams the we're readiness. the and out of the place as building feel to well U.S. been key the dermatology roles process medical we strong experience. commercial on medical great a in launch and number deep Their the and of executing team filled a hire months. plans the We've against office in sales with managed been in to they're have out very building of are now. our teams

Giovanni Caforio

David?

David Elkins

go overall we'll By continues now initial we this recall the may for X.X anticipate billion, end synergies, to the question we about We're commitment. indicated the on before, being thanks well original at the of as extremely over-deliver execution you $X billion. and was your Great year, which commitment. integration on

what So next as billion getting to X we into year, is we're that targeting. head

initial and synergies. good over achievement continued execution the our of on expectations So

Giovanni Caforio

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

Operator

Our Andrew Baum with come next question from will Citi.

Andrew Baum

Yes, thank you.

update have poignancy the your on to what And is cardiovascular Number question relation First your next talk actuarial be you partner coming inhibitor, just And the you light [Indiscernible], to you. for program? to what to thinking will and additional terms hand Thank favorable. from if you able you FDA armaturing talk data XXA Phase for would well anything. can more for before your in Meeting of seeing that obviously X or to on a Analyst is extent perhaps us you zoster, to have that's in TYKX. trial how your in we Could also you second, III Factor X. a some wait as Phase could the datasets April continuum the up, year until are program then you're the about some label, unfavorable, comment Obviously potential recent of very potential TYKX? as on comments labeling

Giovanni Caforio

Andrew. Sure,

by start at just a ask programs. and investor we'll on giving meeting, perspective to QX me the Let comment then the Samit you

think we since years few portfolio as will and you we has the a X closed years. and So to about Company be on lot an last give the getting in together the objective really that everything update happened Celgene has over of our It November, the primarily in middle is happened. the acquisition of

progress about with we'll talk so And pipeline. the the

programs, them opportunities Company. Some the commercial about see we'll the talk the of from outlook we asset for and the stage is

Specifically, on opportunity a there focus an to those. of be will few

that are earlier. modes and review includes hematology that those. were and Milvexian as update be we'll have and example, opportunity sell at be will the AAHA progress at ASH area, They at event. with in you. is know to the our making that we also presented data expected just meeting, and which you discussing for Breyanzi before forward second-line to the We're an another mentioned data So to

these Samit? on that examples are planning of you just of includes some updates the So were at the referencing. of the the that that discussing it And we're some meeting. datasets

Samit Hirawat

differentiating the see Thank in these overall profile have the is you. not follow with the that to before. TYKX inhibitor regards signature. perspective, data believe perspective continue as And don't already And what we've jack any than lap other way from the patients TYKX we infections this been parameters having long-term to stable the perspective, cardiovascular a a we like we The remains profile shared inhibitor, disclosed in before. data

it year. go continuing in the forward to engagement next we are as and to So of patients forward agencies bring to second looking the half looking we the with

in get about As be continue terms you well going will discussions there in sound jack of labeling and regulatory once with to a Again, if as to are ambitions shared. is more the update any that, see concerned. as as so it the it don't like the as we're inhibitor, go we JAK other not future be into place advice, these are RA we to far agencies, as in really thinking we

Giovanni Caforio

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

Operator

Okay.

Carter Barclays. Gould next Our from question with

Carter Gould

question. morning. for the Thanks Good Great. taking

was get something doses, XX-meg that the are end above I in psoriasis think terms specific know are. but milestone of you what First, maybe the important of clarifying into don't And the Deucravacitinib. and I explore with on an Zeposia beyond, in want the just to demand study. and the I exploring a guess to high you then And be -- commercial. talked psoriasis you sort then year more to a X to sensitive extent in you active Wanted will portfolio. some maybe terms Samit, times in little what's doses about just bit tick and you maybe of sort Thank you. how broadening you start hoping thinking the have given it's of question see of start the a know of than compounds I litigation, X the ongoing get you're access. about your bit and higher X of in needing backup topic you a anything tangible but maybe see

Giovanni Caforio

why Chris, start Sure. you UC on don't demand.

Chris Boerner

Yeah.

aided The over are see, sales interested still utilize really, already are product. that you the the the we and in the that We've in very restricted having feel of we and teams success customers aware strong. Virtually of since that Posey is with has we're of estimate awareness And good relatively very as all performance the XXX for very since we a remotely. for in-person trialist spite with good product. awareness start very access you And good team been gastros approval, the execution So have have over seeing trying me are who begun of well environment, about XX% the now The Frankly, got let the XX%, we engaging Posey. see is awareness that unaided survey around execution. approval. in to it. both

early but feel are. So about from where good very days, we we an standpoint, execution

with get that you the get half very, key attention with far, we lot next year note, first we're be continue is think ability year. more As second a -- where the favorable very sit. XXXX additional, we happy we very commercially performance UC of so begin seeing payers. as strong be access that into to something when momentum But and we feel into the and part build will start we going access is to generating our And to of volume to pay We good volume about to. of this

Giovanni Caforio

Thank you, Chris.

say say, Before comment I that to ongoing dose, just me that litigation. the let to ask any not related really at BMS litigation is Samit may Carter, backup exist. Ducrava to not just on want Program all or going that the comment I any to we're on

and relationship is no completely different So there. there programs they're

Samit Hirawat

add we modeling to in higher Program on thing into about we experience. doses over is, that tell without PK we I doses, specifics a Sciences the based the taking as selected are into the getting as which minor of just And than use the it, can and talk here Yeah. the what account you historical

trials the for program, disease Crohn's see next don't now, will the are way the point, well not. certainly colitis. get are doses we from that we're both will ulcerative if data need translate pave these know an what that higher into we or will efficacy as and certainly once trying as at will is right we're the to that we say in future that this available, proof-of-concept We to the pursuing That's

Giovanni Caforio

our next Can to question, we please? go

Operator

with Take Bernstein. question our Gal from next Ronny

Ronny Gal

and morning you Good thank questions. for taking the

of one the first with is the populations on only. from some about data The space. There approvability PD-X, PD-X full-on has debate been Asian

negotiations safety any balanced in a boy, I data price was will of in of Washington be basis ethnic more had not to will risk in will oncology take wondering product to that exposed populations. but off for difference still that second the You've was the drug be if will the to Part taken, space, is there more you're the Part whatever the for in there some obviously giveaways either play D. And discussion scenarios trials, PD-X? a negative various B, seems of there there's pharma there impact there the of if that. we Is is your clear any in DC reform lot is be as be oncology wondering is discussion with brunts to types. across a to a the or contributing scientific generated to on I given this out, efficacy that focused that catastrophic in insurance essentially concern discussion And if in basis different or seems populations the on area. It's price your around industry

Giovanni Caforio

and to Samit ask development. question let I'll Ronnie, then there start just on your me about PD-X comment Thanks,

by question the future. lens So like the me And is point of out-of-pocket patients. affordability improves that's we made of that that in like for perspective, there what's medicines it's that really saying in of reduce changes, reduce that change introducing to patients may to some Part with exposure a your respect disproportionate to support. And market we the like whether start a support to forces B. in answer we that also difficult my these redesign happen at any that potential impact reform Very that innovation. primary this actually in impact we look primer perspective, caps don't establishing reforms product price overall what's to benefit that to invest is lens here. important reform. I not? the That's oncology to the are or is from And elements of go the part number forecast of the what think -- ability from in are to just the of applying. let important industry difficult continue actually

therapeutic I Part actually across portfolio, B look D. portfolio, at actually across our very think you the Part versus the it's perspective when from diversified MBS of areas,

speculate can't I so impact on the be And reform of us. what any would

actually is and for would same invest innovation both us affordability improve the that time, at discussed I to being to hyper patients in really impact of continue what's but scenarios continue partisan yes, in advocate medicines enable negatively. the some of reforms to to for Washington important think

Samit Hirawat

regions we by sometimes in region Asia. of provide to how have some starting the portfolio, we you seek we portfolio by the our And terms just trials, data, in the where left that even clinical a or when world, globally. countries we means the file the which we when And have and conduct countries. of in from broad do in And Yeah. them off those subset we approval Including that's including country. Asian in very analysis

population where have the a tumor may regional and trials occurring clinical XX-plus comes that that it conducted major have We globally indications trials. be in differences see to now across populations of types because not XX As mean difference required doesn't our of differences. start don't representation inhibitors, clinical PD-X or the we yard larger That approvals.

lead a to singular -- not. just will rather thinking keep in when approvals or mind So about trial I country than that

Giovanni Caforio

question, go Christina, to please? can our next we

Operator

Morgan take with question our Stanley. from Harrison next Matthew I'll

Matthew Harrison

Great. for guess Tim -- Good morning. Thanks for taking the I me. questions. I guess

how the And to think at and well. you So whether I'm specifically, wondering we're just that change about those. your branded there's to I be Biogen you're about ASH, TECFIDERA as thought you second-line that the data just it, look commercially your get from wondering if talk I'm as their then coming MS if on data to of need thinking follow-up t transplant any I'm to compare Does wondering for commercially Thanks. appeal first longer-term Kite then, you going study, car assumptions the to on back about wins Market? comes how market. you and successful. on about could think study differentiation and at any second to product if you're the looking Zeposia, we that you And TECFIDERA versus think or

Giovanni Caforio

Thank Chris, you. a the Zeposia? with move second-line can to Just some me let add comment on start maybe then And CAR-T will Matthew, Samit data we and comments?

Chris Boerner

Yeah.

on Zeposia just very So quickly.

an in Tecfidera been that's We have us. predominantly within on the competitive branded cannibalization -- limited we of portfolio. impact obviously seen utilization don't anticipate tech that shift that any a change. potential very on Tecfidera of the We've and would impact have generic then

oral. right in continues we in now EMEA not as focus one are only ourselves also which becoming number the number side scripts, to establishing on one written Zeposia SP, of be but the the terms Our

When commercial in it And at see T way, so disciplined be, CAR and that the will population perspective over you a into that be physicians. to segment for second-line of focused setting, then basis. case-by-case those those just physicians it take very to And I'll generally, really tend opportunities very setting, on focused you a very give and on focus physicians that. who who to open to who a number divert and on there look me our second-line let generally continue the on defined are then a of number of sort where of possible, look Samit. transplant physicians a There's are are avoid transplant. There turn

ASH. commercial the accordingly standpoint, that be we've continue we'll about a adjust And excited we're data out And to data Samit. so and from look seen that And forward play obviously so far, seeing presented at to

Samit Hirawat

that continuing the regulatory from just ASH perspective, a from And the in a forward perspective. from is are to we sharing excitement data truly endpoint at this BFS and particular second-line looking data Yeah, study. case accepted

soon engagement to possible. forward as agency getting again getting patients to the looking as this with So the certainly and

overall to obviously follow patients as survival. is will for cards We safety And follow-up therapies and for continue required long-term as well.

those future and have the the will in in endpoint data we at current time, BFS, and and study will that of the evolve be primary presented. hand be So this that shared was will

Giovanni Caforio

Thanks the go so question, much. Christina, can we to next please?

Operator

We'll take with our question Scala Cowen. from next Steve

Steve Scala

like area the Thank Does you an one this it Company. supplement assets of has lupus look interest area? would questions. you. of for seems that's question. all needs it feel in couple A [Indiscernible] to M&A or to the Lupus strategic So

the on Second call at data AHA, question is where on this mentioned see. is, was we're the that factor about it excited to on Company going

safety noted quarter data see we're data. call, On the going and to you dose second the is Samit, that finding

you AHA is Phase have that in see will dose we more see than what and Thank we that? that safe, proven III is the conclude we or should So you. it might

Giovanni Caforio

do Thank want you. you Samit, both? take them to

Samit Hirawat

for a we next as you, is Thank will Absolutely. Lupus Lupus we well. or that in assets developments which and which at our Lupus we that starting a also get have with of ongoing Sure. Deucravacitinib Discord other couple data questions beginning Steve, some XX the we looking part ongoing, studies that, at you first early on of as all, are controls.gov, readout your know, which of study of will and we for year, later the have have

covered four of targets could we've Milvexian From those And set in was decision-making that of being AHA, then are believe and the do is the data broad see go data the of for the several medicines we've available, define you'll of we takeaway. that perspective, has, are to in evaluation from Phase One, said also those we as that exploration collective be XXa for range in future III, a an data. indications study for at broad explored range forward. there be pursued leads So future. of two so of pursued things one to Lupus and really study those SSP the will a to once future the range intent

going a it very bleed Second, when to and to to overall we we importantly but pay see is risk bleed to from perspective. a bleed. not terms that, think important minor differentiation And only and and major efficacy, in bleeding of be wanted safety about attention

month So the than discussion we investors those probably at you middle the are next the the we of see kinds AHN, have will certainly meeting. and of things presentations that a for in have and can

Giovanni Caforio

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

Operator

We'll our question Leone from James. take Raymond with Dane next

Dane Leone

for give you questions taking on I'll you to the and update. me. Thank to from congratulations the -- it

you to and that to from a enough EBITDA. of of going And is Eliquis's XXXX. new The back operating to obviously there of the historically, different Or drove brands additional said, and portfolio from to REVLIMID that was erosion from from debate cost Taking into will a Firstly, -- overall bridging your away, the even us Optivo along question be the angle, like there up, acquisition Celgene has the efficiencies the just impact steady-state that generic been of with margin Celgene Bristol need growth post of for heading going maybe Celgene. with with offset accretive that an lot belief was operationally a lot ramping followed. organization. margin.

year a could lost one growth there essentially of portfolio. EBITDA from be two that's getting So existing or to the whether

Secondly, a aggressively lot Zeposia quick more team ulcerative start brought a studies for one has a me. why been and mild-to-moderate the colitis. to moved not of population in per up It's

appreciated. around plan Thank would be So there development any the you. thoughts

Giovanni Caforio

Thanks very much.

to said as I'll we always through we happening you same the will from actually first that We've earlier our can a about business grow the about better going comment perspective, our slope give believe the said consensus. comments of in and of perspective exclusivity the conservative the perspective of will let the of will me that what that some or our the make time. the be there that But portfolio So particular over Revlimid more there. just a that -- about ask time, think a period of how brands profitability made in launch U.S. David David slope strongly I'll on all, be in past, enable think to reiterate we of just start, were the forward Line we loss I growth that than period. that. the At Company fact we the and

David Elkins

in low the and confidence from the last we've the very disciplined of think brands, to you gives that thing resources we in reallocating of question margins the ability brands further which a been that our operating earlier, the very many I And if of note low-to-mid discussed launches, is is for our better very maintain us in. in and launch say XX% our about confident seem from the perspective, with our head portfolio products standpoint other would Dane and through the those on thing things of our doing have Thanks those that driving on strong as and as about XXXX. the a is, there's to I have product, nice Zeposia we're that. also And synergies in-line execution high-margin an One the Reblozyl. may after of ones we're as the And you are margins in launch industry. run against being into year we others, top-tier and disciplined well a been you Those margins To we've as Opdivo side next MS&A things but well. the talked products on strong very P&L other some rate the as the efficient that. from and portfolio couple

that gives progress. what we as us in operating confidence in our load to keep that's those ability to mid-XXs margins So,

Samit Hirawat

well in plans Crohn's have we not in with this in as terms as ongoing indication we disease, patients obviously currently in any got MS, for and the the do Zeposia, time. are have UC UC, And mild-to-moderate the of drives at

Giovanni Caforio

Excellent. Christina, for I time one think question. we have last

Operator

Okay.

with Our from last Blair. question Matt Phipps William take our

Matt Phipps

Good morning and thanks for including me.

supply and flat just well? you second also the or which comment just those next that explored on year? would relatively dose Crohn's the with in Abecma less would going Ducra or trial in to is I that be expect until the late explored if vector in doses the flat occur half should into And quarter. of mentioned more you light and issue be can then, being it of the But we said resolved, think You fourth there's FLE, higher was the is as -- CC the maybe different amongst indications how

Giovanni Caforio

Thank and Samit. then you. Chris

Chris Boerner

very to quickly as just said ability anticipate on update growing calls. commented we we've future next you are year I supply that how on Abecma. obviously, we get into additional in and Abecma information on first So continue to staying increasing have vector half the also of Yes, but, the give next year. you we'll we've don't we on QX, for sales focused any

Samit Hirawat

some CD. have it doses, change again, we and the dose over are relates There as them UC to in doses, on and optionality the and to here and the dosing but And similarities amend Deucravacitinib patterns here.

trial looking adjustments as any there to teams needed the continue we are data see X our work RDMC of So are for trials. if into will well the either with as to clinical

Giovanni Caforio

any strongly. great to the participating Thanks opportunity very continues brands We everyone. with to look to We The to strong November of the day call. for a Team Company, the and growing pipeline questions Thanks of discuss middle outlook available very, the again have are the evolution will throughout continue had you the future the be the our we in loans answer of Thanks, and of in quarter in-line forward portfolio Investor other progress performance. the and have. when Day. a his for together day. team rest get to good

Operator

you concludes this Thank participation. today's call. And for your

disconnect. now may You