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Bristol-Myers Squibb (BMY)

Participants
Tim Power VP, IR
Giovanni Caforio Giovanni Caforio and CEO
David Elkins CFO
Chris Boerner Chief Commercialization Officer
Nadim Ahmed President, Hematology
Samit Hirawat Chief Medical Officer and Head, Global Drug Development
Chris Schott J.P. Morgan
Seamus Fernandez Guggenheim
Geoff Meacham Bank of America
Terence Flynn Goldman Sachs
Tim Anderson Wolfe Research
Andrew Baum Citi
Luisa Hector Berenberg
Dane Leone Raymond James
David Risinger Morgan Stanley
Gregg Gilbert Truist
Matt Phipps William Blair
Carter Gould Barclays
Call transcript
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Operator

Good day, and welcome to the Bristol Myers Squibb 2020 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 Kevin, everyone. Thanks, us Thanks quarter for third morning earnings for call. joining XXXX our this

Joining morning and Chief Hirawat Board today’s Officer; Chair of Chief me Nadim Caforio, Head Officer. Medical call and Giovanni this Financial Drug Hematology; our Global Chief Officer with are prepared Ahmed, Chris and Executive Chief participating President our Officer; Also David Boerner, our are Elkins, Development. in remarks Commercialization our Samit and

can slides posted with to we’ve follow note, you remarks. along Giovanni that you David’s and As for bms.com

Before forward-looking we read get going, I statements. will our

forward-looking We statements, During update important SEC representing Company’s these upon relied statements differ our by not this forward estimates and of disclaim including as date. in to our specifically factors materially prospects call Company’s looking we plans any constitute today various indicated filings. forward-looking those forward-looking any will represent those as make should discussed statements even statements about of the that if future may estimates from be future as change. the statements. a as our results Actual estimates of These and result obligation

these exclude on specified We adjusted With bms.com. will it are to financial items. hand the over to comparable measures financial comments Giovanni. measures, are also Reconciliations which non-GAAP our available at to focus our of most non-GAAP measures certain GAAP that, I’ll

Giovanni Caforio

safe morning, and you and perspective over Company Tim, our adding strong Company, it good I has past to performance like I few a will since I into that would overall. been families Company, recognizing everyone. we quarter first was healthy. more year across details QX in go the the hope the my and a But about are great almost you, on to new a Thank the you established moments. give quarter that your year. very

long great we growth a very-pleased has where as term. Turning the is multiple The near, year successful Company to far. make of a with urgency. values, consistently ability integration and a innovation, dimensions. for culture Starting including great to shaped our on our us ago, across medium and of in goal with with focus our deliver to of our promise The transformed by positioning Company X, I progress. our slide that on a we integration of continue combined been a so our testament Company a strength to collaboration, sense am execution

of driven from our commercial Our From original have performance we synergy perspective, strong ahead brands. line in capture is a expectations. our

and new Inrebic, four Zeposia launched including medicines Onureg. Reblozyl, have We

and pipeline. trials cancer entered supports have further the with year, Yervoy. first-line opportunity We have across metastatic we strongly which with the the market both seen adjuvant past successful we’ve where settings, and Starting of growth the for on potential our lung Opdivo Opdivo. delivered immuno-oncology, the In also the

in adjuvant different is X as tumor leading types. Opdivo results a for Specifically, well-positioned in medicine with

to Beyond psoriatic eosinophilic for immuno-oncology, Phase we first psoriasis. deucravacitinib trial for X importantly, number decision ulcerative to and Zeposia to a presence from include with in colitis, data move very-encouraging our These programs. in continuing assets X immunology, are of the in data data Phase from top-line esophagitis cendakimab and for in X our TYKX our inhibitor trials data arthritis. registrational in Phase deucravacitinib for have now strengthen we Most

potential as through be diseases, in across psoriatic and to delivered potential far, top-line by the talk important multiple that two transactions, the to data for as colitis Forbius Let and business number the invest acquisition asset this continued the strong we a me stage best option financial of And oral for well capability Crohn’s with patients development with assets early MyoKardia. deucravacitinib. position Revlimid IP announced on very-encouraged to Eliquis, disease. future, our of have lupus, the broader take ulcerative including and including strengthened finally, results a arthritis, Dragonfly are moment Based psoriasis, we so we for about with seen and

transaction multi-billion drivers the our potential turning obstructive with we’re potential, Now, which and a a look dollar first-in-class hypertrophic for MyoKardia the further to colleagues to medicine has additional to indications believe grand the acquisition closing with welcoming mavacamten MyoKardia, Bristol chronic cardiomyopathy, We and Squibb of treatment impact. slide value X. the forward team. MyoKardia new potential of and from mavacamten, is high-morbidity gaining heart Through disease We from pipeline. QX, the Myers patient during

are navigate advancement launches potential. current business Company Turning therapeutic of disciplined Squibb and to all our businesses, for building have be significant in-line and growth our more slide the are opportunities hematology, X. significant four areas. to how and has of successfully areas, well growth Today, pipeline strategic exciting significant we well-positioned of specific, as all Opdivo near-term as our the portfolio position launches, Myers pipeline late-stage oncology, development. strength opportunities. short-term cycle. Eliquis we medicines with Across breadth long-term robust CV, and are through immunology, am I of Across and we the through in a of optimistic about four and To combination assets new Bristol

have launch these most We their just are have medicines have expansion over launching new of beyond the eight now And the that next important to indication. opportunities or initial potential year.

full with the And transition well CC-XXXXX, continue sight inhibitor. of years. development assets as potential our Including Factor iberdomide assets more clear and three will as XIa registrational advance next cendakimab early pipeline to with gained and next to XX two than close development. over the our cell modes to with have our myeloma to of multiple line in or seven registrational our relatlimab, set We to

we that and together briefly our focused David talent full will slide of pipeline, [Technical with the provide quarter of on let the potential. Difficulty]. Given the are our seven. delivering to details, strength our people, context, on turn on me of portfolio more let the strength Within but

year highly to in very on markets, pro with competitive a compared X% forma increasing basis. last to well same continue First, period sales execute we the

addition, positive as IO, progress good for are the our well during progress first Based seen the as across the quarter, making trial strength in have captured launches. guidance And ahead, continue of for trials deucravacitinib. we In Phase reaffirming. including on X significant are clinical we we increasing our the for opportunity and about by as EPS this earnings which year growth be to business, we non-GAAP the our are year, very-encouraged EPS next guidance multiple

ever new have new and it David, indications that across Myers well-positioned short and to look prospects. stronger. to hand Squibb I patients in with our with term. it all more Bristol our that hand over come. And us financial never very as future reiterate I’ll more want is areas, opportunity. Before than I provide about combined strength been today critical can to extremely future, key built confidence the benefit to is with that, encouraged the say And has I’m to before Company David. I’m medicines, optimistic launch what multiple with we our and over flexibility tremendous mass we about to pipelines the I

David Elkins

year-to-date very Hello, our of thanks delivering Thank teams, Giovanni. this global you, by quarterly I’m everyone. pandemic. strong in joining very our And while pleased operating results and again call execution the for today.

our discuss top slide line performance. turn to nine Let’s and

versus year execution, Third growing quarter a and our X% pro revenues on reflect strong continued prior year-to-date basis. forma to

can growth. robust our you As a see, demonstrated vast majority brands of

our with our of brands key year. me Eliquis underlying XX performance growth be and demonstrates the Starting strong U.S. teams to on provide best-in-class profile of continue double demand This commentary prior additional let execution our XX% in launches. robust digit Now, new the on with brands. TRx slide trends of versus and

you year, in coverage be expectations the larger discussed the per it, of enter should component previously, gap related this which increased to as component we This our XXXX As we coverage more our with of size to is Medicare our This half gap net QX. pronounced second a line liability impact expect affects accrue results. patient gross as this to for our was and a the mix. sales in is And and to increasing a in its U.S. strength Eliquis, including outlook $X prior we XX% the the strong one internationally, in within many revenue approximately France, Both, billion, the with for growing the United Eliquis the of class. enabling number NOAC of remained growth from quarter. Internationally, globally, in Germany, see factor markets be and very continues growing continue profile, share strong to Kingdom. versus year. resulting fourth patients

in teams been the on well. U.S., executing have to Turning slide XX, very Opdivo

growing XLA. We And that by benefiting of buying approximately X% for shares X%. What underlying you in lungs is more Opdivo. return the versus continue favorable and strong see we’re share have approvals reflected the encouraged across to see key We really underlying acceleration customer QX as QX high-single-digit Underlying demand, sequential to to indications. grew can with first-line Sales was two, in growth cancer XXX quarter the as well demand Yervoy. driven of growth the from first-line patterns. adoption the from now lung patients by

Japanese We patterns to board the in Opdivo across these quarter, Internationally, impact primarily return X% versus and the sales and a new in reimbursement gain markets, saw RCC European melanoma. rebound as markets seen demand in supporting expect the strong to commercial with from stronger growth fourth growth demand, a for the up to continue, for reverse year. sequential continued indications annual to by execution to driven prior XXXX. but Sequentially, year-over-year first-line buying our we’ve the we

lung this melanoma, new patient generally Yervoy chemotherapy starts some also tumors, be forward good the we the most in and of limited recovery quarter. to to continues in saw look impact first-line QX. Opdivo there Europe COVID in across While bringing of notably to softness patients we And in plus cancer but

things plus cancer, promise annual we confident Opdivo shows both makes several first-line invasive priority which clinically, for launches such and were To a look near-term us forward, more and which the first-line several XXXX, Opdivo have even sum As our bladder the esophageal teams expectations we year-over-year continued we the for indications in granted muscle Yervoy commercially as growth for executed and and gastric including expect and up, additional RCC in the potential review. and XXXX. adjutant well, Cabo in for in

starts. portfolio Pomalyst XX, new while longer being and Revlimid perform to experienced our which patients. in-line to This grew pro the this forma a and now XX%, treatment duration. recovering. Pomalyst of Moving patient well based earlier increased to Revlimid lines duration with use a strong treatment XX%, was In sales treatment forma therapies temporary better basis. driven pro XX%, impact myeloma offset softness for existing had in increased driven Revlimid a on double COVID increased in And duration. from markets. growth by on continue forma multiple on Pomalyst European XX%. on ex-U.S. small by we of and is performance digit and very major brand And COVID, primarily increased treatment, the share slide increased to growth grew U.S., strong some impact of on therapy for adherence observed pro by in driven new with for minimal patient is sales triplet ex-U.S. duration ongoing treatment

We are patients strong patterns. of new seeing to signs prior returning treatment

moving robust brand. over quarter U.S. two. $XX launches Global to off of on sales has awareness been were positive of the to feedback RS-positive anemia. the million, Now, recent representing In with MDS-associated slide XX% the significant the with physician quarter approval on remains XX. Reblozyl our growth a start in sequential

still new patient on the patients retention of the the pleased including patient be product the we While to and early, with treatment. to adhere launch, majority that continue with uptake

initial for recent the remained well although MDS-associated demand encouraged the the beta a very by reminder, product waiting with are proportion launches We underlying new and going early patients Germany Austria well, option. for of early Internationally, a uptake as in anemia. significant As patients in very bolus driven a by in launch. as the of treatment thalassemia is

also receive in we beta XXXX, thalassemia globally in of reimbursement. We Canada over markets look received to the forward approval associated and various launching course anemia for as

Turning to few seeing what through by encouraged the launch. we’re months we’re first Zeposia’s of Zeposia,

as and We’re focused driving sclerosis. on demand Zeposia SXP leading multiple the establishing modulator in

and teams executing our have commercial are strong We well. commercial secured access

the thus receptivity with initiation prescription physician pleased are seen we’ve and We far.

for approval newest the on September Onureg, granted to FDA, our moving by Xst. which AML maintenance Now, first-line launch, is on

maintenance and in approved the FDA in maintenance like it the This expect the has the were a physicians for a The the from of is that first will to While no there Europe feedback with for as resonating Onureg, educate new medicines with many And review that largely route demonstrates market setting setting is after prescribers use medicine launch, promising. administration chemotherapy. in intensive setting, in XXXX. in about previously well. oral of time some underdeveloped, patients. other message options overall MMA the patients under in and is approval maintenance is treatment take convenient early only very been survival

moving capital on slide to allocation Now, our balance XX. sheet and on

generate with third quarter Otezla. large cash with to cash $X.X on billion We marketable billion strong the from flow a approximately payments We including debt approximately gain continued of the for and in tax significant in $XX after securities. ended Thus operations in the quarter. payments, amount and tax cash payment liquidity position associated paid down is

Our half EBITDA and ratio, capital a than achieving less end debt the by one allocation priorities remain XXXX. to now and unchanged. which times is expected of Delevering

through against dividend priority. our we not have activity, our continued business our and innovation We development. To on commitment discussed, business in touch to development raised as investing future Giovanni our

MyoKardia. well of as for third Each and acquisition scientifically these strategically quarter, recently financially aligned, We including Forbius, with our our transactions agreement pending as in with is license of announced have sound deals executed over acquisition Dragonfly, line our attractive. development, criteria business of some important the

be We development, to strengthen for shareholders. long-term growth of will for and value additional to active for searching continue business the the in further our creating profile opportunities company

to XX. year-to-date, results our Now, updating XXXX let’s the strength we’re guidance of full-year on Based outlook. turn on our slide

year-to-date. range. between are to of billion the sales at upon revenue the $XX end performance and based higher expect the billion, $XX.X range narrowing we We to be do strong our And

operating to Turning expenses.

We total do our spend in be line have related and in MS&A slight some shifts generally spend our expectations. expect We R&D to lines. to with

expect $X.X business the one-time close advertising the our full tracking being time, taking very-pleased additional our $X.X out by We and same be the accelerating approximately decided mentioned, Giovanni now expect the increasing R&D as to and original remain to rate year, approximately expense, support full-year we with be together, EPS adjusted DTC now expected for to our we ahead capture, year. we $X.XX share. of now be between billion. tax approximately offset we synergy which, our are MS&A, all as billion. For is to spend such This make this to is per At XX% lower expectations. range we And $X.XX as investments, to

guidance takes in some the continues well mentioned brands. hole, to as the which Eliquis I affect fourth competitive account associated Our of with earlier, into as donut revenue established dynamics as continued quarter, our

reaffirming EPS associated $X.XX during forward our relates which guidance look XXXX guidance, we to on more absorbs our acquisition. as $X.XX, normally it we Now, as are to MyoKardia providing We dilution the our call, of color do. non-GAAP with to the XXXX, fourth quarter

I Q&A. our turn for for and want allow for Before the year-to-date. results results These over now we question-and-answer, around confident to world back Company. in of long-term move to remain Tim the thank the I’ll Giovanni outstanding teams me outlook the to such to call all delivering

Tim Power

Great. question, Thanks very first Kevin, can much, go to David. we our please?

Operator

Schott Certainly. of from [Operator Chris today first Instructions] comes J.P. Our question Morgan.

Chris Schott

I And, all, know confirm, talked did Opdivo. at events a from what was is then, just maybe bit first guess, on see Great. shaping question you’ve little in But TYKX. of this year. a we more Thanks my think, out like, the Could little the for you profile? some you issues? imbalance about a progress terms study? the questions there? still the on safety there’s two profile on lingering us congrats just on questions. I made safety any past. of safety And of not, of see or much any JAK-like you’ve elaborate in there will on second thrombotic lot up And maybe to just bit very just the on some all I the here, small the the that help

so of us a just that Thanks bit adjuvant build Could remind are launching or much. on that do next uptake, number will these over metastatic those, out indications of have fast year. these the a take time? little some maybe expect in you longer like indications you seeing settings, You’re we’re to

Giovanni Caforio

Chris, thank you.

for placebo, in the the clinical I’ll This first but question. Chris, then not apremilast result in. and TYKX that. from a differentiated believe moderate versus There a continue seen superiority happy profile, two a is to And, we action off for severe psoriasis. believe that We in on out, perspective. that. X statistical we Phase as seen IL-XX to we From played have to that on start about well in of before has effect Otezla and all, think you with look, also of what well inhibition, as which we are first mechanism specific the to or read has studies, the only do of the perspective, seen as and X what we’ve IL-XX, have Phase trials I’ll think, we that we’ve continue talked versus interferon from I safety TYKX the we From TYKX as downstream is believe out. the pass Opdivo-related very alpha has meaningfulness

go the we in in data. happy And meeting. Of course, are. of the Phase I specifics to look the in very first They be will second But readout quarter XXXX. forward overall, of future medical are can’t the of X the the I where we into the presented

Opdivo Chris let it question. So, talk answers here from your about that pass hopefully, on. on And to me to

Chris Boerner

the setting. specifically. opportunities exciting just a in number adjuvant do Sure. of Chris. bladder I’ll We the highlight Thanks for have maybe gastric question, and

path CR. has as who talked three systemic about, space get As There’s a coming excited patients we’re patients of to in radiotherapy, a opportunity very about where This ago significant therapy need. that’s we there’s talked the of -XXX. the about those CheckMate chemo of neo-adjuvant way a months little with about quarters getting few And out unmet cancer, here. are previously used don’t respect Samit gastric is those

space. very -XXX good for IO first again, here be are happy the great And DFS therapies we’ll is a again out primary those with for great launching a This bladder, Opdivo there lot options number X,XXX the with from And respect that very in way as and the -XXX. clean air. forward we’ve this space met seen the at we competitive years. X,XXX a Again, in air doubling is saw we And standpoint a a with U.S. With relative about the with systemic coming profile. is for there’s in the of not we’ve efficacy endpoint really, to of to of where space patients setting manageable said, safety no clean of patients. to treated there look relative results So, another in And as a much here. the

So, we indications. would expect of reasonably aggressive in uptake both these

Operator

question today comes Seamus next Guggenheim. from Fernandez of The

Seamus Fernandez

with the progress Samit, Can on my higher next quarter all the to well. where week Congrats just you other JAKs. dose and on that going as is see the seen give that’s dose, problems -- psoriatic XX-milligram actually really question in us we’ve arthritis. the we’re

sense something Just be colitis, opportunity colitis, ulcerative about enthusiasm really to data? trying the we interested then, areas XX get that investors emphasized the really particular? to much. those of think in ulcerative you’ve for for we that’s looking profile, Obviously, your -- should as is in are presented. they’re like where I that, is so in be this in. Thanks But, your think what incremental to IL-XX in And about product XX, that

Samit Hirawat

in the keep the fact. dose, X very in is said a mind you the we trial study, are press dose. the as you the poster X perspective about. now we said, the talked abstract But that what for we Thank dose the and you psoriatic POETYKX safety When mentioned, is that’s X Phase at seen at dose from as you dose Phase looking have X-milligram and X-milligram appropriate We you safety in as and the the quite management got. so of efficacy overall readout, arthritis, see as Also X very XX-milligram And profile the a do question the study have response. in generally in correctly older both, at the dose. you, XX-milligram look the we in ACR Seamus, in have used for at as a well. the dose. then, And see to At good Phase the the do release,

very move plan study we space. data at of continue we’ll dig into look I in study. happy readout X Phase we overall, first again, the dose to X of X the that the the in course, deeper -- have as in we second quarter we the But are we year forward. as Phase psoriatic next earlier, said Phase with tested And arthritis So, the the it in as

I think not But, differentiation. efficacy. that’s about it’s the just So,

the benefit risk. balance us benefit to combined And X-milligram reasonable the have efficacy safety for that’s seems We ratio. risk and a dose why from quite

the hopefully important. to ulcerative the with again role, as IL-XX is colitis, a administration, psoriatic I it and to be the play going the big in differentiated to inhibition for ulcerative are ulcerative and about And as relates already, we’ve Crohn’s we show of talked future program. be able the in patients convenience As future the disease said, bringing very arthritis looking both with will oral the mechanism IL-XX that you treatment, now and the mechanism well. then in efficacy mechanism, towards the safety well yes, differentiation, colitis readout once think, TYKX and TYKX And and colitis for

Operator

comes question Geoff Meacham of next The from America. Bank of

Geoff Meacham

for lot, think guys, couple, a both of Chris. had questions. a just Thanks the I them for Great. I

the indications? And can beta-thal Reblozyl, a the you the really about maybe I between have sequential know obviously trends guys. Thanks or first-line been lung, in quarter. label the one some strong. So, far? say X% the in first-line the early. when what for the trend don’t Chris, just it’s expansion? maybe before there feedback of have and I two MDS ground already at between see what’s share trends second lung to a just look this so the share, you been think And help Was I the from lot, U.S. so and Opdivo, distribution on much reasonable the gained you us But, of cadence guys But, uptake break

Chris Boerner

address Maybe and the over to Nadim turn second I’ll to then I’ll your question. start, of part it

just to So, with dynamics first me you for the respect give let Opdivo, the quarter.

saw with happy lung, first-line that the in sequential quarter. second. specifically and function of a I’ll favorable obviously, is about the So, the for the in That demand, we talk U.S. growth

was we’re We in offset U.S. we’ve quarter. impact That’s very had that see in to with with This saw happy in IO the that thoracic the And also, currently. build. with And the That And seeing of by so lung. The as that to we’ve lung, steadily. seen the decline to got what drag that we’ve sequential uptake partially David a the noted, first-line respect still continues growth second-line on previously. the some launches for said, mainly first-line discussing function far happy a inventory was part in indications. we’re Opdivo increase eligibility that is with been we’re

noted is market continues we here currently the to high As very share earlier, be in single The execution good. the digits.

a steady share leading in this lung. And we in of the we’re trials of the nice a new at importantly, week-over-week. seeing stage example, have growth first-line launch, for So, number

team’s overall, to very given But, performance the with from we’re a this entrenched lung. discussed knew, set seen. standpoint we the pleased of in a previously the with we we’ve We that So, that here. launches, be just competitive to as uptake was different dynamics continue be happy first-line going

over Nadim part second of So, maybe turn your I’ll for question. it the to

Nadim Ahmed

Great. Thanks, your Geoff, for question.

of a couple make the I’ll regarding just So, points. launch, maybe Reblozyl

really the always U.S., And brand use, that doing David way. out we be good with team if well. very said, exactly at predominant same the is pleased high awareness, as field demand, launch in MDS, had and far, very that you so playing would it’s said the least So, remember,

the seen a the beta-thal, little bit seen the majority from the is we’ve effect is the And but halo since of on more launch. uptake patients. U.S. a is beta-thal with today, predominant bit a in MDS. MDS use But, thing So, still MDS use interesting little we’ve

in the MDS, we globally, where your different as world, for for anticipated. it’s Asia, U.S., the thalassemia, you across different beta higher, launch Mediterranean. as there’ll where prevalence is But we Now, today, predominant still example, Thanks question. see Geoff, a profile, be had the regions the use exactly in

Operator

Goldman from comes Flynn Sachs. of Terence question next The

Terence Flynn

Hi. might alone. get was on wondering, for and And first, the endpoint Thanks us you can if you’re then, give path the know you approval that you neo-adjuvant regulatory Opdivo on for the update taking second on just confident mentioned more just XXXX? questions. the you trying lung, could that I and there, understand any and of kind how when you. expect if guess, PCR how the how much ahead a your environment? so, are carry into much is spend to that I much of tracking from synergies question, COVID forward is expectations. we should to And the synergies of Thank of

Samit Hirawat

Thank you, Terence, for the question, here. Samit

for pathological new still earlier, in the mentioned a signal these for because much for benefit Chris a long-term may complete into As need early be that patients obviously patients. required there is medicines response with disease to able get to

not very endpoint, of regulatory is Now, well validated you course, this said. as a

as continue are of what the to course, especially with regulatory patients So, for now, our FDA, first we for looking well. agencies, survival continuing as event-free also forward dialogue with the to the these data follow we

based will continue and today the we we generate with a as posted you clear think patient in the approvability, endpoint. we I the can data. guidance on more our dialogue make Giovanni? time, current keep continue So, in progress. At David synergies, And I of follow-up give the future or to for terms don’t obviously think we

Giovanni Caforio

David, why you go ahead? don’t Yes.

David Elkins

our so capture ahead year. this this pleased really with of Terence, original for our year. the ability we’re see very question. for expectations we’ve And been to synergies encouraged actually to Yes. our Look, synergy far tracking that thanks capture is

synergy overall on expectations very the of So, to year, things the our are close going provide we’ll further insight that after achievement, we well. but

Operator

next Tim Anderson question Research. The from Wolfe of comes

Tim Anderson

a to TYKX. question going I on have back

there wondered relative differentiator, least titration, Otezla require most were think, side we’ve But, the And better doesn’t and drug no effects be X, a to I if in your dose view better tolerability being Otezla, require side effects. proposition could also So, titration. GI dose investors Phase in psoriasis GI at that value with efficacy. because there’s

Phase of better another when tolerability oral So, might differentiation, as beyond yet dosing X see the results, also see we beyond better efficacy? area just we full and

Samit Hirawat

for question. Tim, you, Thank the

for As at the look not be comparison the good versus a we there overall placebo well followed, to Otezla. comparison, is said, you versus that as this the design only is for one the but also news the trial if next as study

an these And to about. so, as tolerability contrast or talk the only from from And important from perspective, to a opportunity me those compare to very a not perspective. it going but physician And and Certainly, all on efficacy, certainly perspective. commercial convenience are be will safety of and let there will that. a have to Chris on patient the perspective we be comment pass implications

Chris Boerner

the think, said see opportunity based excited the we question, the I we here, that for I coming Thanks we previously, data that Yes. on with we’re POETYK. have mean, as out Tim. of

moderate continue to algorithm. coming on this to real have a we Samit spite that believe as would build the choice in into a think, I frontline of the new treatment is market TYK establish is an I ascending severe just these where biologics space, patients. to to mentioned, branded in for what opportunity oral What say, dermatologists

where go move typically oral, out, I market, they start drives also think to they as And is it So, topical, preference point a with then you to they injectables. patient choice.

have these very that in play profile. to we needle profile phobia TYKX, see novel a you tolerability efficacy issue think an do is and with favorable MOA, concerns, an formulation, safety on here. really a we safety oral a very the And So, strong dynamics and strong focus

the we opportunity so, got And as establish oral TYK the we’ve in here space. leading to think real

Operator

Baum The next Citi. of question Andrew from comes

Andrew Baum

you. Thank please. of Couple questions,

Otezla. First on

of And oral you defer Otezla agent slow in XLA therapy the setting. to marketing, the the as can you of initiation cell displace or positioned give shares you As second, or to is then, the with could the the tolerability, choice, just in in U.S. actually perhaps market biologics? us for to first-line extent what non-small XXX, seek think efficacy, it given about

Giovanni Caforio

Chris?

Chris Boerner

for be we burdensome would try a go to reflection to moderate-to-severe back data TYK question is Sure. I They’re And Andrew, thanks Otezla this going think, has typically what with at branded in We probably -- psoriasis, of administration. that go opportunity TYK for routes for in we oral answered best on fact these the space. the mean, large a with previous to find. I and the of the the treat going they where question. to the are to. that’s I based looking how of that market think, that is this less choice way can the patients the respect to think activity opportunity dermatologists activity are I the With

concern However, a here. safety is prominent

we opportunity therapy potentially patients the existing And think to we And an the that opportunity of respect so, orals have also with believe provide have we to prebiologic. that displace before I opportunity XX% space to and biologics, is this of spite to on the remember, of to coming about ultimately in And that’s only biologics. where a number get a move biologics into ever patients of market. new more

actually opportunity we do have to we think both. So, an

first-line David market we mentioned, relates to being in lung the negatives. digits. mainly it have and As and And the the is recent PD-LX current and XX, regimen, single X we high PD-LX as as used uptake XLA the XXX we’re previously mainly that’s then seeing of said The in PD-LX less regimen share the expected. first-line as to share, in market than

Operator

next from Luisa of Hector Berenberg. comes The question

Luisa Hector

anything out liso-cel, you’re any wonder, review? And from you. now presenting, sets whether like from update various I then, any data Thank ASH particular you FDA and have the can we durability Hello. response? update abstract, the give to the there’s you’d ide-cel of and from point

Samit Hirawat

you. Sure. Thank

let certainly, start also, will to then, the be and to I’ll me wants go ide-cel. comment then first, wonderful. if that And So, with liso-cel, Nadim ASH

and these very are are continuing to been now had presence. medicines few So, few that Celgene on that, abstracts data the as BMS data both And Celgene based well perspective, the have on there -- data. that last for that has are obviously, are we presented past, to being have over certainly, the late-stage years, ASH gather in so more a Having development. said moved And important presented.

the of important patients both ibrutinib as as group So, interesting. number who one, in well -- combination single -- CLL the activity and in where are venetoclax, the and liso-cel received therapy quite

as need venetoclax, that be with as the patients you recurrence a that evolve. will if been ibrutinib them treated If in response CLL you tolerability a with there to as the or think subsequent or patients, future will CLL continue has overall the for disease rate, Especially and these at durability where therapy of well rescue have population look with the relapse.

forward moving response going Another evolutions and but Velcade data combination as dictating then further. And we’ll through, certainly set how the continue dexamethasone. and the might that those are daratumumab be to proceed will set, and data will seen earlier as be then the burdened look we you how have triple see into dexamethasone, to with as well these iberdomide iberdomide to in as comes settings presented, start are data we rates in abstracts, be the of as will

So, From other completion have to the course, heard we for very except which a scheduled deeper communicated, with that of the his look that from for dialogue We’ve Washington. the for CELMoDs We’ll of to we to year regulatory based one we communicated will don’t our perspective is facility. done we which the And and the then, have earlier in had inspections and next as iberdomide second perspective, happy facility any agencies. of Giovanni CELMoD’s independent share, comments. opening inspection it. already trials the it -- we’ve liso-cel fact continue on for the is not facility, as continue other look with you much the progressing be into in as

November. we of liso-cel, date PDUFA have For a XXth on

continuing don’t same where I are. you and or thing, we are of know, Giovanni? of we a something, Nadim, our ide-cel, That’s to XX add that have want For if PDUFA date XXXX. dialogue March we

Nadim Ahmed

No.

Samit. well, covered Thanks. it I think you

Giovanni Caforio

on thing progress. is is, only close update I discussion would Giovanni. with will our this only as I is as add what thing the we liso-cel, just you to regulatory with The The -- obviously, to authorities always, add would Samit respect mentioned

Operator

Dane next The of Leone James. from Raymond comes question

Dane Leone

progress. taking on Hi. all Thank the congratulations And the for question s. you

are probably now to you would do performed, perform and timeline arm for discussions terms quick how for rate the that would pivotal terms to iberdomide, can have nondisclosure make give the path When this arm pathologic us us the ones clinical me. do Just the some in the own actually disclose to And complete a endpoint, an you as Revlimid that think, think about you when for our item a regulatory as we then XXX could studies combo lot patent powered still are to market? on I offset actual if of have in well start? least able would be you community study? in And response of would of be chemo then, study to so the the at a there. assumptions and thinking on expirations complete? longer get that you how and was how Could until

might kind the any helpful. development term So, would be Thank path of longer able, given be super insight you you.

Samit Hirawat

you Thank question. the for

So, let me the pCR with part. start

it’s So certainly, be that future for on data not at certainly presentation we’re dependent an is proper aspects, medical independent a for because look endpoint an meeting. That discussed. the going to the opportunity can of a regulatory

So, we’re to that. looking

calculation we the have se time. terms at not of this I shared analysis for think, per the trial plan the the statistical assumptions in made details,

that. share been is not be for data chemotherapy leading we’ll had to a previous published able So, and that But certainly, presented pCR there responses. to

assume So, that. can you

those types to of in need between regulatory differences discussions continue we’ll then a important what and what chemotherapy the combination agencies have of as to the be will Now, the delta terms becomes with are of nivolumab, meaningful. to

readout said. to next dialogue are have combination the be the agent single data we’ll well then then mentioned to agencies do regulatory and regulatory evolves earlier add And setting, the discussions would in evolve those the you. sometime data study as trials From line the dexamethasone, the and for ongoing the iberdomide I’ve that? we’ll triplets us that with later previously, decisions you we data points certainly that trigger and has perspective, So, settings. year, for the the to first suffice something for already with as in will line as discuss the the doublet Nadim, communicate is as continues launch the first want if line just dialogue the made, evolved And once as plus a to the we’ll in setting. see plus earlier data to

Nadim Ahmed

couple Sure. add would I a of maybe. points just

diagnosed So, you relapsed disease. the made, thanks, doublet move point for especially Samit plan our question. very always important, been is, your to to the know had Dane, newly as which that had from The triplet, in and

then be had the up in treatment you at then asked will setting data newly move question an foundation diagnosed late-line early how ultimately, future. important impact the relapse to and about setting since the and from ASH setting the the these on having So, we Revlimid

development So, we clear plan. have a very

gates ASH As point of Samit triplet that the to all data the course, pass have said, the as we at we starting go But, we’re clinical is now. through. seeing

forward. So, question. your we’re Thanks opportunity, excited about the for moving

Operator

The next question Stanley. comes from David Morgan Risinger of

David Risinger

you very Thank Yes. much.

So, have please. questions, I two

And other do a with you FDA color liso-cel? or this follow-on with that recent by over me It point. on be the ocular differentiated have in a those could is, provide data? Do should to for you issues following And been discuss there manufacturing expect to we inspections? the should question to BCMA more on what any see your inspections, is, CC-XXXXX? have First, discussion need seemed are confidence you second tox you Thank that manufacturing the ADCs expect with multiple to BCMA myeloma. then, when associated you. And, profile

Samit Hirawat

for you the Thank question.

informed we as the be this our scheduled of any we Bothell, able Washington both inspect in not plants Washington FDA inspected. inspection to need past, liso-cel, but to in have Company our at second well earlier, disclosed For been plant. in plants as as time mentioned Texas, the as that the They’ve in has the one

as actually to go restrictions, obviously have they when ensure kept that to the they safe to where in desire the of travel know, staffs what doing we are you go. pandemic. they their are this can As because honor and And COVID they

decision. the in the soon as as and the as know well, forward some we’ve get let the with We’ll to the to that patients going As conversations you obviously possible. past we -- agencies the be at bring approval the look seeing we point to able to hopefully, as are soon said

et around to going the comment not about obviously specifically are We cetera. dialogue inspections,

We’re dialogue the generally been happening. has with happy very that

of X. early toxicity, be we we’ll On to along. we front, Phase we’ll are able in time It’s in that are the to but certainly, go multiple whether comment we or as ocular for not, the ADC absolutely and differentiate aware mind myeloma, the keep

patients to evaluate that. for continue the We

think, we year data escalation the be next late still because are see sometime phase. would I dose in the first would we

to share certainly, soon it be so, presented, to And medical with as data be that and enough to able conference you. are the mature the as we’ll bring

Operator

Next question comes from Gregg Gilbert Truist. of

Gregg Gilbert

do is that more what you end you’ve have in then, franchise deliver And with environment? mass the XIa generic MyoKardia. maybe On have one to approach on cardiovascular the Factor add market enable it in the what like of XIa, eventually Giovanni, core and a at Eliquis other of and approach, hand, in that Company. will clinical asset, cardiovascular, of strategically, it spectrum to terms a kind a specialized you profile for think more looks a made value Factor you very clear be

of consider or And would you in modeled? how imperfect Revlimid assume a terms in Thank end cardiovascular. David. for then, if you. BD that focused the LOE for How least strategic the I do and being across other in be coming years? your We you at as in And vision think additional So, step-down But, cardiovascular have follow-up spans one information. obviously the you general more you the curious to want Street describe has right, it’s that. in

Giovanni Caforio

And me Let cover maybe then, to Samit on Factor add. and Revlimid XIa, specifically LOE. then, Chris start. the cardiovascular your question maybe about I’ll we’ll And and ask

has case assets Eliquis develop value through assets those Eliquis, an look the proud to and all, with cardiovascular, we the of consistently in area of an us, Company. the differentiated And evidence of real at when is our your to and it ability say, of answer the for of cardiovascular done to been I’m yes, different first of So very example question, importance establishing really we’ve value maximize approach in me to a strategic what as medicine. let the take

really so, cardiovascular our good you inhibitor, at a Eliquis, our and feel whether Factor commitment at and we about look ability cardiovascular. in look mavacamten you And to XIa execute to

or asset the XIa partner a assets those like could as reach together that because I think, want choice broader to those the have the a us assets In different Eliquis the a know, very approaches of indications. enables you company multiple made a to another working market of we be are primary broader between be. to care into cases, Factor support asset that require large development development and across with in investments we

it’s much strategy. it’s more mavacamten, at with consistent we a of failure look with fits you really when precision And our very R&D think, which in the actually, I heart pipeline a have cardiovascular. to nicely approach cardiovascular, early

I what Company be approach looking ability at one really to So, asset and is continues the really which we the best a different execute, And has an maximized versus we need to depending cardiovascular high. unmet capability. don’t on it’s at in approach, necessarily But, the demonstrated think the order one have where BMS then, needs other. it’s where for to as be The take of areas value its excellent.

is actually approach it, things. we really way think about the that’s -- look is because precision when we acquisition interesting because an So, consistent really and asset really, MyoKardia at

move if And Let XIa, to our Samit add to then, he and differentiation specifically we’ll Factor ask your me development question just wants strategy. anything on on Revlimid.

Samit Hirawat

obstructive remember, a from mavacamten, the hypertrophic arrhythmia, that are on I perspective, thing the about you, one add would ones treatment also experienced. Thank fibrillation The Giovanni. talking that that have also symptomatic, patients cardiomyopathy, we they especially atrial are that ones with

patients still doses done. one, with of necessarily get don’t because risk. There used need very remember to treated the are very bleeding back of and XIa, as are then stage the these are the true in and Eliquis, Factor for have very risks be and treatments, to Coming are be available, currently are helpful Eliquis. number even available future we aware is, well there certainly not with bleeding I in certainly many potentially and might mavacamten of two when patients. that the is well, are So, of to cardiologists things we be anticoagulation there important on going that treated what some that again would patients And and Eliquis think happy

to is The probability. cannot unmet even at secondary medical the such medical and And patients be on therapies need second studies the enrollment. maybe one, in that at agents as are And that probabilities; we looking of we’re therapy stroke second Factor a second who in high high risk and XIa that decrease and treated number have bleeding the what XX% the currently the is its very therefore, is the their in currently is unmet development first prevention that X background stroke study as of look for background ongoing the ongoing Phase had that need patients are of indications program, very secondary and antiplatelet experience the strokes. combinability terms of top stroke is XX% antiplatelet for

data important us aspects the once are that X available. those make go So, will are into program, the Phase development the

me Let to further comment to side. on on pass David it Revlimid

David Elkins

we great as We IP well you settled Revlimid both as the made front, progress know, with on with year And with as Reddy’s. Dr. this Eliquis.

coming I’d to did by third starting that the -- cliff, on Dr. And XXXX remember, than with as aren’t Natco, view say which XXXX. the we ‘XX. about clearly Alvogen. which we as a generic a have equity did settlement public a a a And to time see in you, analysts with at the sell-side more agreement Reddy’s the remind volume more settlements, the grows acquisition, But, entry is slope, that conservative We single-digit it all entering we Natco have is not Revlimid took as other in time. full XXXX, at and just we some with which

said, the So over ‘XX flow will we for add with cash business period that that believe through from ‘XX. Revlimid potential still significant

Giovanni Caforio

you, David. Yes. Thank

just slope to XXXX take me of sorry, time, question, during over will I think, to the specifically the when reiterate, period at place Revlimid to your -- Let we which XXXX look between XXXX.

we’re brand a to strong. I and the And has of strength validated of been of the made pipeline strength our renew our overall the The progress real not granted to we’ve settlements slope time, business to performance really, a IP First had continued already At in by continue with of way view IP mentioned. think, and that our the has the good. starts really to out ability same the IP beyond the company playing really a two the of is at it us all, David the revenue been has be that has the where confidence that given we portfolio. be point as modeled it

So, we renew our lose the time to strongly time as I in feel portfolio to I mentioned the as which we at exclusivity. good perform our over really beginning, will Revlimid about very continue that during what ability confident execution during so I beginning. to from up strong, to in do set That’s far been me And continue ability think, which our successful has be really very time. to the makes

Operator

from The William Matt next Phipps of question comes Blair.

Matt Phipps

patient a into Wondering combined you like Thanks the asset the and wondering more you’re if you TGF-beta psoriatic similar And on congrats kind setting, on -- at plus after this contrast recent molecule, like quick Forbius mild something going question moving to alpha quarter. that study. PD-LX study, a moving nice bispecific with acquisition, the if a look to and Opdivo if then advanced a also, could of antibody antibody? compare just track a maybe the versus monoclonal POETYK

Samit Hirawat

Matt. you questions, Thank for the

aspect, very TYKX we so know with POETYKX study. happy on the of First you results from the are that the all,

have the in also as overall psoriasis, that as go arthritis it. already on And arthritis profile we dictate think in to Mild second broad have well deucravacitinib where at readout. underway You obviously this evolve the know we evaluation lupus, with the study in we We also efficacy disease. and related ongoing indications and lupus, have we certainly we of a next data on there where that the and psoriasis, program to bowel of psoriatic psoriasis. safety evaluation in look is psoriasis SLE, about will the terms as other inflammatory eye the

TGF-beta PD-X have the inhibition the When particular On front, certainly will but the combination look competitors are caused pipeline, of of TGF-beta bispecific very is nivolumab, this entity important. with that And we own the specificity aware also relatlimab, at by know, in we with as TGF-beta, the only of at not look have. we we our you the development. course,

for the evolve, X pave for oncologic be get that combinations Phase looking study and we to will all did see looking dose what we’ll and and at dosing the combination forward. will So, those way be schedule strategies as patients the with the the indications,

two having drugs strategies think, separately will looking the us I give to forward. ability opportunities combination more for give

Operator

The last Barclays. Carter today question comes from Gould of

Carter Gould

Any need programs? sort the decision to coming on that be an Fc on program. about change back you you can the closely you. two again. Should year Thank related Street taking of pick iberdomide mutated winner between see how guess, question. to that also sort or or [ph] competitor for for going the their or Thanks point think XXXXX, quarter. for CELMoDs decision be recently. in guys. And morning, space we at region, past, program the some Good outlook I been the the to made Any discontinued most of first, discontinuation language updates is differentiation of maybe perceived those maybe or on Congrats a you the balanced be where to independent coexist? running you’ve next appreciate a on to Great. with there? a relatively In there that to doesn’t they sort commentary TIGIT the then, is this

Samit Hirawat

Thank Carter. Sure. you,

questions. I think, great

the et [ph] the the on molecule, we know own program study. X seen their details we our we molecule, have the from First But the in side. cetera. is from the And certainly the announcement Phase competitor and don’t all TIGIT of discontinuation of on have side, which certainly, structure of

combination We able very also forward. the early where on be see to to the path looking been go have we to define at with

Fc you that of go the to others As certainly perspective, be But, side. inactive further program or inert or own where our say investigated before portion, early be portion the fate we I of to decisive of can specificity will on the we’ll data made in update be. terms Fc the from what and evolves, decision needs too think

follow TIGIT future. on to the more in So,

of XXX On and and molecule with further said, we in very past, of because our third-line those how dexamethasone side, But in in CELMoDs XXX how the developed became overall potent Revlimid little if preferred plus you is the are earlier. IMiD the iberdomide line started in is the recall, of upfront a studies patient of a pomalidomide, bit organization, molecule. in development. shared response second, [ph] setting. the in they overall both the were Both XX-plus-percent Iberdomide population. rate We a programs setting it of setting. data as pomalidomide for up Revlimid the then are then the development development set and the

looking the a in lot continue investigate to we will to have evolve. also And we as we that that in mechanism the from we we of only good at well to our as the perspective but So, be with therapy T-cell ADC mind own available platform. have, as from may CAR-T can with where the fit data strategies we also evolving avail is have pipeline, position keep that we engager, these from drugs terms that multiple have opportunities actually myeloma see platforms of what the combination to not what best, able the already CELMoDs, cell

But because he So, ourselves on let the of you. wants investigated can than Thank those hand way, broader elaborate be opportunities, me a anything our singlular Nadim to add ask a further to CELMoDs. in certainly CELMoDs few further rather limiting to this. have we in

Nadim Ahmed

for and thanks, Sure. Thanks, Samit, Carter, question. your

the we’ve the done the and with in pleased right Revlimid with both. as early And said, think, seeing data we’re now, I for So, same Samit very past. Pomalyst we’re

clinical different CELMoDs. both patient with discrete are very the of potentially see segments you coexistence where there So, needs could

better maintenance example, setting, disease, more see relapsed you potent with tolerability with come for In profile. the a could a setting So, high-risk CELMoD a through. CELMoD

up So, combination going possessing. we’re to data with look said, but objectives both our at are approach. we’re multi-modality the I one pleased And continue think, is to this to how come then, key as with Samit of

a patients disease. late-stage seen the as Revlimid diagnosed we’ve sequential newly already lines I disease use progress plus CELMoD or to the should current multiple And BCMA you and can therapy So, from through with Pomalyst. envisage of through treatment CELMoDs, of say,

be lines important, commercially. of and both combination BCMA CELMoDs do the we think across therapies, and of So, segment that patient could a different clinically really

your for thanks So, question.

Giovanni Caforio

all call Nadim. today. thanks you, Thank for you. Thank to you And joining of our

We have depth think a pipeline. lot that our our and to discuss, I of and business, speaks of to breadth and importantly,

is as a patients first will of a very, been strongly a exciting company. pipeline address position can in active opportunities and for significant and with substantial And I really that to year future. launch today strong say for Bristol very needs a year that So, well it’s Myers us position near-term a the and we unmet very with very confidence discussed, really new Squibb

And us. able answer good thanks always, So, Thanks, further to may Have you for be again everyone. team day. a questions will our have. joining as

Operator

Ladies and that gentlemen, concludes today’s participation. you Thank your for conference call.

disconnect. now may You