Bristol-Myers Squibb (BMY) 31 Oct 242024 Q3 Earnings call transcript

Good day, and welcome to the Bristol-Myers Squibb Third Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Mr. Chuck Triano, Senior Vice President of Investor Relations. Please go ahead, sir.

morning, good and you, everyone. Thank be I'm we Bristol-Myers and at you happy joining call. to appreciate earnings our Squibb, XXXX here third quarter

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

slide quarterly and presentation bms.com this morning, our Earlier follow Chris posted can you with to David's to use we that along remarks.

indicated I'll in Before statements. those we forward-looking plans the a as get discussed this everybody various forward-looking started, company's prospects statements and remind Actual make results we factors, statements about future by the including of call, those those result company's will may constitute during important filings. differ that SEC that from materially

of upon estimates of should date, to forward-looking estimates and disclaim any our statements not statements update as estimates today our obligation forward-looking relied as even be any we representing specifically if our represent change. and These future as

certain are also financial most comments on our of adjusted to to non-GAAP measures We'll available measures exclude at certain focus bms.com. comparable items. Reconciliations measures, GAAP which the specified financial our are non-GAAP

And to with over that, I'll Chris. hand it

Thank you Starting for all and on you, thank Chuck, Slide joining us X. morning. this

continued near-term and execution our on building for focus reflect growth. results long-term foundation quarter sustainable third Our the

for solid we quarter, the across demand saw products and our During portfolios. key growth legacy

advance pipeline managing disciplined programs. in to remained expenses, important and continue we We

XX% into decade. in that primarily and revenues. constant achievements have in half These assets the are me Growth now exclusivity of few revenues approximately currency quarter. Let at next well highlight increased total portfolio the QX young account for a

strategically legacy in opportunities. also growth invest to that generating us well, flow Our cash allows portfolio performed

in in our Cobinfi, During the we milestones. a speak which I'll to several the presence we clinical achieved of regulatory with moment. neuroscience reestablished and Notably, quarter, approval

cell oncology for And we treatment cancer. lung portfolio. received leading strengthened also non-small earlier FDA month, approval perioperative OPDIVO-based in an our We this regimen

advance to cancer, registrational we continue We lung data at our in combination to oncology, Phase first-line is we innovative advancing new high-dose clinical shared now X for ESMO, rolatlimib positive which our nivolumab In opportunities. pipeline. plus III. data Additionally, presented highlighting

And PRMTX making assets we we progress talked modalities, the radiopharmaceutical This ADC I other past our we're program week, promising and the all about bispecific also and Phase across tumors. across for presented pipeline. our ENA, data at promising including our

debilitating acquisition Cobinfi many truly how are addresses long-term safety of Karuna X. the Cobinfi, highlight in for for treatments. alone, Slide strong effects FDA U.S. schizophrenia to a significant acquisition of from delivering mechanism growth Therapeutics significant strengthening approved reflects profile. the There in its are Karuna X.X with milestone example being This efficacy We're for health. the The and endured adults Turning proud novel first from outlook. our is KarXT with and whom known in side a schizophrenia unmet it as marks X approval value the in patients. of people mental we have of that to formerly progress needs key million approximately most of is label recent decades, the older

We notable medical engaged the groundwork the compelling delivers payers The and a team sales an laying Cobinfi BMS for atypicals. and access sophisticated without patient associated built team been support to efficacy with secure launch. has side effects services. experienced develop with successful

schizophrenia data with Phase adjunctive XXXX. ongoing have III clinical expected programs in We in

we trials We progress expanded next in to are And expected agitation, ongoing autism program speak start Alzheimer's actively more Alzheimer's potential data in indications, for Alzheimer's ADEPT in assessing to Phase Samit and in XXXX. disorder. track and remain Adam registrational and we disease launch disorder Cobinfi year can spectrum have our cognition, the other with Q&A. bipolar schizophrenia III psychosis on in

spend a on against Slide you strategic X. Turning moment our to updating priorities. I'll progress our key

First, medicines advantage. a on we we're competitive have transformational focused where

our best-in-class serve includes KEMZyOS or treatments therapeutic patients advancing therapeutic like first hematology, Reblozyl, areas. with and This to our mission are across in cardiology areas products with driving We OptulAg. and oncology Breyanzi, leadership

At X milvexian. as the time, continues we're strengthening pipeline programs. that advance by key same well our prioritizing innovative asset to

we AF want We well continue across in commercial opportunity. very indications, unmet well. fibrillation large an our to need which considerable update III Phase a related atrial encouraging as recruit to to particular, to see share trial, continues as Today,

our we see increase side. you'll an in As and clinicaltrials.gov patient soon enrollment partner, approved have J&J, on

embolism This of increased is review readout planned the are rate rates, strokes we a because XXXX. at than on enrollment systemic of originally and the and maintaining data this event supports time, anticipated, in seeing lower based

in As reminder, paper, may We study of the the progress size and sample the based in be review program. a indicated that as our confident event rates. published described design design we of on remain adjusted

Beyond programs our milvexian, to continue we our includes well and degradation Cobenfi. NEX-T therapy, to protein This as platforms additional right we as win. other have for radiopharmaceutical where a cell advance CDXX indications

operational Our driving priority excellence. second is

opportunities billion overall We investments end of -- serve needs We in And long-term these be savings reinvested are and best spending growth. that and will prioritizing will ROI returns. remain high patients' on reviewing to that deliver XXXX. accelerate by into track the deliver savings $X.X the

with commercial We are a and execution. stronger becoming pipeline more agile company

a and in by the performance programs. key our Our greater QX, the growth this for demonstrated drive see process. the was We excellence progress of of front Cobinfi approval on acceleration of portfolio as continuous operational

to further -- such, quarters. opportunities coming we're improve the over efficiency As productivity and exploring

long-term priority Our strategically and for is returns. growth allocate capital to third

through of progress innovation half to growth in of will our own during We invest we pay We our balance delevering near-term on billion as QX by remain of $XX well externally. our debt We're pipeline sheet. the focused sourcing the further XXXX. to to dividend, made our are first and of track on committed target goal continue strategically and down as

on CDXX This the therapy. Annual the of promising At to is College Rheumatology's Breyanzi present a X. American construct. turning next-generation in cell upcoming data Slide Meeting asset, we immunology leveraging NEX-T November, Now for will I Phase milestones our

We on immunology while the about are physicians indications multiple launch benefits both immune immuno-oncology in important subcutaneous In into we an the decade. expect patients the the decision our this We XXXX system. next for FDA's deliver by resetting early to potential patients formulation its December, leadership will optimistic anticipate provide benefit extending for late in nivolumab. and across of

X/X year-end. also have track the as on data III data psoriasis psoriatic should also from arthritis in Phase share competitive of strengthen to patients We're arthritis. psoriatic line for SOTYKX by roughly This help top SOTYKX profile

on outlook our to Turning Slide X.

will strength the our these year revenue target we full year-to-date, and our of Given results are more full guidance. both David our EPS detail shortly. in updates discuss raising year

I'm ahead, our ability shareholders. confident to and our Looking deliver in value long-term for patients

I'm with areas. Slide in summarize To achievements X, our pleased critical on

is potential Cobinfi mix bigger patients our adds overall growth with serve to and transform another becoming is asset business Our accelerate to a U.S. approval multibillion-dollar portfolio growth. beginning as more of component. The

cost. you as Our in across XXXX. pipeline management, and groundwork data continues the for keeping driving important term catalysts long-term focus disciplined in momentum with to XXXX and build on sustainable look we flow to on to the advance executing company near a our while milestones in with additional initiatives updated growth. forward We laying focus actions significant underscore These lower maintaining we the near-term expense are

thank want I we our future close, performance are BMS I patients for their the Before building in strong employees and quarter. and the serve. to dedication a Together, for we

to turn David. Now it I'll over

share pleased I'm Chris, Thank and to performance. good morning, our everyone. you, quarterly financial

in a our all and comparisons XXXX non-GAAP P&L will reminder, on otherwise to period an be sales the underlying are exchange, foreign of all a same basis impact basis. rates growth As unless from the discussed which on references excludes stated, made

quarter some driven by up start brands, led legacy our Breyanzi, including also we with Our on of quarter performed offset progress demonstrated in well growth Eliquis, double-digit with key solid by and with partially U.S. lower portfolio XX% primarily another Reblozyl, sales brands. with higher by growth The third portfolio growth of third highlights performance Let's our Sprycel. growth, sales. Slide delivered continued sales XX across the quarter commercial from

Sprycel POMALYST a for U.S. the back the August. in and reminder, on X, for September happened in LOE Europe LOE the occurred in As recently

us focus half diversify and nearly approval launch foundation U.S. continued mix our quarter third on Cobenfi, and from the continue growth. execution in to deliver the the sales sales recent our of to Our commercial And with provide enabled stronger of for portfolio. growth a will

the in from Importantly, we optimize to invest growth cash the legacy generated strong to portfolio will flow continue opportunities.

well as growth third products. going important reversal inventory quarter. it's KEMZYOS This key million some into to primarily and sales across an impacted $XXX quarter brands, brand Before approximate build second tempered note as the performance, by and several Opdivo, from the of that immunology Optulag, were

Global business outside growth higher the sales with of Opdivo XX. demand the start on solid Let's U.S. oncology our quarter, were in reflecting Slide third

ahead, to global by the to Looking formulation FDA continue launch nivolumab of which, range. in focused full approval we to year the Chris receive sales on as is expect the anticipated of year-end. mid-single-digit subcutaneous remain We be and mentioned, growth expected approval

portfolio With this next extend anticipated our decade. into to potential approval, we the the will durability of have immuno-oncology the

we care XX% Optulag in demand. by U.S. Optolag, years with quarter, in strong become of X melanoma double-digit the delivered a first-line Moving share. launch, in primarily standard driven growth to post has the third market

such as from benefited third the the Brazil and strong U.S., markets uptake in the U.K., Outside launched sales newly quarter Australia.

Slide growth to delivered share our anticoagulant the on third sales portfolio cardiovascular and benefited XX. higher U.S. worldwide Eliquis from demand in Moving the market the double-digit and gains. sales leading is quarter.

the net an U.S., Eliquis Sequentially, gap. key the Medicare to to sequential quarter. favorable included unfavorable compared and as prior impact seen higher historically, of we've sales sales demand markets across inventory U.S. related Outside reflected gross the coverage to

KEMZYAS. Turning to

Third quarter an for demand number patient sales and increasing patients U.S. on more commercial by driven new starts strong drug. than of doubled,

saw nearly steady third with commercial adoption from a patient growth doubling number the than the we on drug, ago. quarter, During patients year more in XX%

reflected growth sales sequential in newly higher U.S., in the Europe. Outside markets launched demand

Reblozyl XX. Now sales in U.S., on performance The grew demand the contributed quarter, quarter. international let's of driven recent strong first-line in the by outside strong in first-line third setting, the were double-digit the continued and turn Slide to U.S. with XX% growth, U.S. in Japan in and the to Europe hematology markets. Sales reimbursement both

improved manufacturing more in on a indications, U.S., sales demand newly follicular sequential cell In and of by driven therapy, year, In sales lymphoma capacity cell more reliability. by our indications mantle than the driven new XX% and primarily X grew doubled and demand basis of in pent-up lymphoma. versus approved Breyanzi prior

expect third demand quarter modest normalizes. sequential as more quarter fourth to growth We from

growth in markets. Also market, third solid well despite performed demand the in and with both bema quarter international cell U.S. competitive in therapy, a the

third the doubled XX. the on of immunology trial in Slide to to SOTYKTU last of clinical year. moving the Sales Now million impact nearly quarter when $XX purchase compared

U.S., the in from year-over-year, launch Outside number sales of a markets. international the grew benefiting

the we associated to Looking this the increased in gross quarter, to with resulting quarter. would similar This approved fourth step-up position. in our rebating net result expect to quarter access being sales fourth from discounts a

over As we said will offset we previously, growth pressures. that time, expect these demand

Slide P&L the on to XX. turning Now

commercial our and financial In addition quarter savings to billion solid $X.X progress our cost execution, third focus steady on demonstrated program. discipline against our performance

from As OpEx recent include in incremental site a rationalization, clinical trial we reminder, the reductions organization across reduction Savings roles in initiated of direct this elimination and deals. from a to expense, offset program headcount. the

majority expect of to year. through we we come savings previously, this said the As the

strategically innovation As are opportunities we we potential in reinvesting high and growth fuel realize to in savings, areas. long-term key these

a saw We our from margin. impacted expenses, XXX driven the product points, were of offset basis mix. by gross Operating by savings in-process to by in deal-related initiatives. partially R&D spend, efficiency excluding about decline primarily quarter Moving higher

from IRS XXXX in Our effective share were tax rate to adjustment newly XX.X%, onetime guidance. in changed Overall, quarter year from earnings impacted prior $X.XX. quarter issued XX.X% third the by in the per resulting

and moving ended billion Now capital approximately cash equivalents $X.X quarter cash, the the debt on highlights. with We securities sheet balance to in and hand. marketable allocation

of contributing robust quarter, billion. third delivered the approximately to operating cash solid both our flow growth During revenue growth, $X.X portfolios and legacy

allocation, focused terms on capital strengthening sheet. In of balance we our remain

of pay to the the quarter, debt. and plan approximately commercial end by We billion. of paper And relative billion to includes roughly of of are our This $X.X at X.X% our reduced have long-term position $XX billion down executing $X debt. it we first

As to previously committed said, we dividend. we remain our have

profile enables address to our these while strengthening outlook. strong cash flow also priorities Our us

non-GAAP XXXX Turning to guidance.

underlying As basis, revenue guidance basis well currency provide remains year. a an as reported on is we assumes our with prior on practice, as which consistent

reported of now full REVLIMID. XXXX primarily to We increase year at X% sales higher-than-anticipated X% constant expect revenue due approximately to and as currency, approximately

legacy, we of REVLIMID billion. portfolios. performance And and the sales updated our with in of approximately have year both pleased estimate are legacy We growth to $X.X full

Europe. in to from Revlimid, reminder, generics fourth other purposes, in modeling in due PAMALISin for should the soften to addition quarter the ABRAXANE legacy brands U.S. a for As competition and

range Turning to impact mix. U.S. We a the now expect margin. sales our of to gross slightly tighter reflect

acquired now expect in to in X% operating higher approximately Excluding increase quarter our fourth for is increases to increase and impresses line we total reflects to seen fourth portfolio quarter year R&D, with spending previous and X%. expenses the support pipeline years. This product

are These of offset our We in full at partially our confident target costs savings to year XX%. achieve productivity least remain by ability from initiatives. operating our margin

$XXX income. income to we to OI&E, from approximately $XX million royalty have increased million and approximately of expense For interest our estimate of due better-than-expected

R&D, first from process rate reminder, our the by impacted quarter. tax acquisition in a the As charge acquired Karuna the in nondeductible was primarily for

estimated to are acquired to approximately Excluding updates to into be tax these of a XX%. the continue Taking range R&D, guidance the our non-GAAP non-GAAP year in-process we effect, expect to rate $X.XX underlying for EPS we full raising $X.XX.

In across brands. financial our key discipline. quarter growth marked and by sales higher cash generation results robust flow continued closing, significantly third were

to our presence near-term in long-term continues the looking forward U.S. potential about the we launch pipeline as of serve We're As we our additional to brand and of opportunity with advance. excited are patients. this more reestablish to catalysts neuroscience its

year-to-date our growth. raised in increased year ability sustainable performance supports long-term solid Our guidance drive to our our confidence and full

Chuck And back now to with that, call Q&A. turn I'll the over for

with will BMO your Markets. Instructions] Seigerman [Operator question from come Evan Capital first And

the this quarter. on Congrats progress

we X it? So when comes as about Can when Medicaid takes the comes to that through give next and Adam, color think year commercial. you us and what looks there's a I access? it you for how approved. of have us walk some puts it But like to now to know maybe should lot

Adam?

about very Yes. approval Thanks, Evan, excited Cobenfi. question. We're the for the of

very you label As in box schizophrenia decades. is Chris, a the we're warning. or heard approved atypical in first the and warnings carry And not class does the from innovative antisycotic therapy with pleased precautions

a launch we And the this are so each attaining for large people We up access. think schizophrenia see treated there after as how XXXX year do U.S. market. about broad million addresses launch this the a picking Remember, in X.X with

expect those We in sales dynamics. and second of I'll describe the see half to ramp the year,

product this First week. is we're really and that foremost, excited available

engaging out Our field teams customers. with are now They're selling.

And so we'll see stocking this year.

a are either is uptake as patients gating Medicaid. or Now of to access over sales Medicare factor XX%

driven. And just markets schizophrenia remember, market different is a than fundamentally that are highly PBM

we XX% move about achieve Medicaid to to a faster certainly take accelerate bit So to we're expect to could work to It that. a XX% going access. in year and

In states to the So have step think recall to a step-wise X roughly Medicaid, really the is fashion. access. in half of about X way

working week. seen completed expand the to remaining the P&T Medicaid several meetings take online course states. are come And prescribe place so states next of across we over reviews this We've deep months. already will the are P&T and Physicians few a once can access

protected Medicare, in this class. a recall, is Now

make any days and medical a XX determinations physicians exemptions to in coverage to of reviews coverage expect push see in take meantime, can decision, have place. we the but through these mandatory payers QX, So formulary before

asset meeting immediately approval with for very the the been and payers very, Our time, response team positive. been teams some and label have to approved payers with has without review our post

that plan this work time. to for very to we the need maximize So product over know launch, a our again, big and important company we we do this to make

Next from Shibutani Chris with . question will Sachs. Goldman come

we are XXXX as expect operating that the at on expense terms to doing be focus Certainly, you've you here. time, would early improving Any trajectory operating seeing dynamics -- And in should the line in top commentary expense of XXXX? same shape lot where top a of you're of been what profile a line the helpful. function

ask David I'll that Chris. Thanks, one. take to

in that recall for about track thanks that on you year. we're question. majority progress to on savings feel good $X.X this Chris, really And achieve we the we making Yes, initiatives look, the had And of the billion we're our -- place.

this least good XX% of year and that really about margin as well. provided for we both guidance feel also at year We operating the next

base, efficiencies hear more our typically give we're line we our relates to fourth cost to to continuing it continue But you quarter earnings guidance look full call. do you'll as and So for in that. 'XX, we're to about like on going

Your next JPMorgan. question Schott will come with from Chris

Just maybe thinking ramp you're a all talk X-parter reimbursement reimbursement details piece. can you about from drug place, the about just is the of on Just the thank in you on how for the there? Once

in largely similar wondering action? case, this I given ramp products. are and are more be we've just a mechanism anticipating existing in of to faster need guess, these than unmet historically, with could we've but I unique your I'm you seen the seen assets launches gradual mechanisms think this schizophrenia, historically

same the in just here, part my large study It's as X you of bipolar what's as when probability in And schizophrenia, obviously you live do additional opportunity? is then and on market data extensions you just start a product very second high about that to view the that seen success think your you've one? the ramp line a confidence

Thanks, part, in as can the and Chris. then well. will Adam take Samit first chime

for the Yes, Chris, thanks question.

to really there's success multiple thing example, schizophonia launches, because therapy. of you've approvals, with than to analog That's approval say be monotherapy cadence in previous where first in perfect going for I'd be First MDD. that seen is the no not is going schizophrenia, case unlike here adjunctive

launch That's to really, -- it. second see access terms of see ramp. in a going online, this the half said, as we an I the how be coming As we is

XX see really to months physicians reviews, push within full we exemptions access through today prescribe medical can formulary approval. XX to XX roughly expect access but So post before

the for thanks question, Chris. And Yes.

mania has excessive are think Then that one, of symptoms as Alzheimer's study the in bipolar, the in Xanomeline thought symptoms for that in bipolar symptoms disorders. published was you of think demonstrated of disease agitation as think course, includes that from came as activity these hallucinations especially Alzheimer's data, well XXXX about psychotic reduction about the so if general, If past. as well we about and delusion, you in schizophrenia, and as

thus the potential worsening are studies no is bipolar mania. of a symptoms. shows conducted far There these depressive efficacy been the that predictive in the evidence in that all emergent of program have So in

of that forward in together, we initiation of to bipolar mania taken So in are program the XXXX. looking middle

also looking in forward beyond top which readout add course, trial, the agitation that are XXXX to on the schizophrenia bipolar initiating XXXX, X to the in of to indications recognition. And additional will be we is that will well as as AD Just of of ARISE trial. be we

will with Luisa question Next come Hector from Berenberg.

On SOTYKTU, year trial. for perhaps into a just and you're QX, outlook color could more on year? the looking and the that reminder the profile in then the of but the impact price access as mentioned a little for you we in next pricing you roll And next add ceraticarthritis

can first take Adam Samit. X then, the and

Louisa. Thanks,

said been QX. And doubled had in plan. performance has we of progress we in the on TCX against ultimately the We improving execution. in Recall, half XX% than first securing our past, like, access executing the slower that's performance year. that we'd As the and than making are more and access we favorable and

compensated that out. impact XXXX. take by expect the But enable quarters approximately increased X market. we time. few We over and access that volume for remaining going rebating XX% could adoption gross be productive now in broader are in conversations to this And wash will with edits to and It's having comes and I step to with a have payers the say significant net

you exclude the and in this. some year trials. versus of sequentially you of both saw saw pull-through delivered fact, clinical when In QX, some We prior

competitive. started we're be to But more prescriptions. share going a we we're competitive, that will going better market is to market remain and exit continue more we as be increase highly to a is this this the well year, as to to work So versus position work going to and where paid as we year, in

of the question, have accelerate and for been study Remember, the pull we Thanks for the as part. readout well. the arthritis to second Louisa, able

the to XXXX. readout the for year So towards poetic we are looking within end both politic this PSAI of forward

profile perspective Overall, imagine, as as think the data in you footing right safety has psoriasis been for readout put us can efficacy program the of about from versus SOTYKTU well. a as a lot in we of since the will the and now generated competitor

in have a lead safety So concerns looking hopefully, to out we've positive, filing perspective will so no the said, that, that forward XXXX. we studies as from read to a

The with Geoff from will Citibank. come next question Meacham

have about to Chris what For is of there change the milvexian trials, your for program, for know trial talk have event Samit cause the think would previously. say But I commercially -- the in lower know that an upsize could GLP-Xs or profile? risk the rate? cardiometabolic the did -- example, use study? event We rate the you this potential Does impact, on changed guys changes you the the in you

Thanks, Geoff. to over I'll start, and Samit. then I'll turn it

Let that me we're by we're encouraged the this outset, just program. Geoff, seeing what at with say

need for Just fibrillation. we're there high think atrial unmet I developing is reminder, area anti-coagulation. where have That's worldwide particularly because an know, atrial in where true million you as a individuals this XX in remains patients fibrillation, milvexian

Xa milvexian risk these of we're patients that improve or XX% is really point due at we we that sample believe those the And outcome to patients. to And encouraging The to study. that blended success increase about despite context this the the remain intended the has undertreated seeing of bleeding. the today potential give the Eliquis, to on like in event Factor rates of to decision for the update some given provided size the

But come XXXX. we to to XXXX. by here, seeing to study potentially what this want over the I a forward We in we're look read I everything out to Samit? do to want This ensure Samit. continues leave you important medicine. we it can turn with, seeing before program and its to we're that to in is encouraged outcome

from program where combination have was from. Secondly, is right started one encouraging in And Phase we in Chris. that dose. centrals.gov. And the just clear size, from our AF, what well that led rate programs Geoff, III remember sample compared milvexian with we doses Chris extending designed an us well-designed view, What the as off the increase gives numbers the drivers to trial program AF which as was studies the started for the with for II to in of very pick current lower seen key Thanks, from of left event of agents the our outcome point it where us as the Yes. reason ACS will that see we you to as Phase the well study at time. in the the had when update we . We

DMC Thirdly, study. rate the the why study event as started, the arm was saw the than that almost we almost the on stopped the think Xx genic more and study because investigation was -- data about in reviewed

continuing know, on encouraged as is they study time. all this periodically of other ACS that. to are no study any you There We are out XXXX, and that the we reviewed truly well the indications read supportive in as Our by are are the at DMC. by DMC should slated And and from track for go this. of route as are the programs we SSP

Gould from Carter question with Next Barclays. will come

for just up Maybe I there. hammer mean but on Samit to prior on wanted the again, question to don't it follow

appreciate in commentary your to conversation populations shift enrichment any what at from be of was on happened there appreciated. on given challenges rate. will mean, enrollment, patient especially I our at increased of what the away the the be would criteria patients or segments. going proximal the those seems ESC, the at talk about there here in but be your competitor I the color event to With Any same

any Carter. of you, to There criteria. are Yes. no change Thank plans these

the to and continue as change observe for except study them the the will continue in will size. We is, sample

with Next come from question Fargo. will Wells Mohit Bansal

dosing into X This plans in I on with longer the Xx have the AD more wanted wondering as to to titration relates trial, still psychosis cognition. Mohit. development We and for was is it it Perhaps starting will day period. if the KarXT Serena dig

on for moving need longer could what emergent do like baseline. be impaired to the cognitively cognition studies? then trial. Was at And to enrich the wondering look it this plan And would like, to you than patients

Yes. the Thank Serena, for you, question.

associated So in direct from AD and bipolar is cognition obviously, is Phase we're trend as terms that looking in xanomeline the obviously action the studies. were of data in the for of next dual that the showed the MX agitation, recognition third forward available xanomeline those studies second programs X mechanism course, The of in well with reason X in program. initiation year, III improvement as the belief to, the of right MX old already with in agonism terms . that conducted of

Your question program. into is now day that psychosis Xx around built a dosing the right the AD

as as indications will bridging we We how BID Psychosis talked about thinking will program well. as instituted that and we there that about dosing are program a patients, the X the so it for into institute can new in we back well working on are we the these be the study that will I AD in bring start

forward next looking Overall, ARISE study the in a of the certainly good now track readout year. and to

UBS. will come Next Chun with Chen from question

on efficacy about going XX% tumors. recent you're as types the solid of to are across We perhaps And what seeing you here regard ORR talk an bunch of a you to the X saw with prioritizing? durability tumor Just that be the data. product? Can

X actually, very thus from the of stood far. our question. data that Really, were it perspective. you from program that enrolled that terms in look and a out types tumor for the encouraging breakdown at the from Thank We

cancer, occur The X very drug rate note a that a patients these is -- long-term program control thing on of non-small XX% for late look cell actually durability. just lung period. the overall disease non-small the you long Our more to about have duration control with and if you cancer a -- at the is that very so patients response where cell cohort, lung in responses most of do of it's good

trajectory As also well, you from our cancer the the about diseases response -- XX.X you lung talk Then of similar about is saw, take months. that constitutes stable duration if cell population. as the non-small already about

that The very encouraging saw the rates, pancreatic the the at again, durability. was at XXX-milligram and good XXX increased second population response doses patient actually a was right looking thing dose, we at cancer very and

patients Some now way year. up going all to almost the a

to those this we you development promising, on later are year very looking look the in so X for terms next program. forward phase update And indications giving of and

with Scala Next question will from come Steve Cowen.

I And guidance is Revlimid points Bristol growth Revlimid? increasing and clarifications of to is million. the They're roughly So what solely X just have about equivalent that's revenue that's to attributed point its X really there are questions. $XXX that percentage but -- is the X Bristol increase really amount

apologize And for lower-than-expected I rate DSMB Asyndexian trial Why risk, then would event encouraging? in secondly, a as back to rate AFIP understand going event failed. point. could had It a but easily is trial a the the milvexian be lower-than-expected think. and -- the I and I

clarity So appreciated. be any would

for over I'll the flip to David question, Samit. Thanks Steve. we'll start to and then ask

the prior we full reported a Yes, and about. good excluding in And that performance to saw why raise talked guidance And Steve, question. our saw outlook thanks the caused growth as for year to that's the Revlimid look, and X% year us also on growth strong versus a X% portfolio raised currency. we billion, performance we $X.X

I other coming said entry as POMALYST. thing POMALYST. is Abraxane is The already we generic facing on generic call, as would and I note, the too, The on Sprycel have in

the sure update fourth all said, So revenue as put additional generic erosion we net-net, we make result. we want our when their in as a guidance we for people models that together, quarter. to raised just the But that

This Steve, And you. Samit. is Great question. thank

look Apixaban for back Just was rate at then the look at to the rate to recall, go apixaban. if you we X.XX. for we and study event

Asyndexian if the in think planned and so. more was what you study about if I X.XX. have even we And X.XX, remember, then milvexian is

you looking as much overall, than blended So about mentioned, are rate if think we it, event planned lower the at event a which rate. Chris is

encouraged not that we overall, this and necessarily So thinking it's are an issue. by

look with continues earlier, this at to and increasing we sample continuing said okay size. I are As and are us it, the study, DMC they

with Courtney from come will Bernstein. question Next Breen

of around the note some in and understand the obviously, of isn't be that through were we to kind challenges. patient to particularly many the and What how some Another share liver question the wanted because these patient script warnings you managed extra physician warnings doctor prescribe require and Covent just some practically of box a do on expect the around choosing label warning, I the attention. to the Can practicalities but a that patients there on label, receiving make launch. precautions kind you to I able to. are that context of sure there is

to can And you some just those so speak challenges? of

the for thanks Courtney, question.

physicians that at efficacy better Zyprexa, treatment and Just dyslipidemia, of know, you plagued ones events stop good as Kobani level they are have least greatest the significant discontinuation where the you than the patients as sedation, or and lead agent. another adverse rechallenge to without that with the offers those see EPS why

that's in some We're of the very large and pleased the with at of we're and the lab recent When label, feedback we're assessments. had very you patients label, the have hearing the just been monitoring the majority but at have beginning, progress look positive. remember, that very, the

to don't we anticipate a So be this barrier.

not recommended. common today and very a are population. assessments mandated recommend antipsychotics this label, the lab Most is in this assessments. lab It's In patient

don't mid-single issue look schizophrenia, renal see And we for digits. at the impairment you adoption. patients it's in So in with when an

pleased its best-in-category together, efficacy taken based and we mechanism So is the of its action to that on safety are very profile profile. with unique

to add what just And Adam is saying. to

well. continues EMERGENT-X, maintained. data And as been the You will the to also but longer-term see safety those who studies, treated certainly the hundreds on patients of profile same, have efficacy and EMERGENT-X remain through

gives us So in as Adam overall lot for addition, of profile that, a the said. confidence in

question come from Securities. Seamus with Next Fernandez will Guggenheim

sense your bispecific for potential your get upcoming of enthusiasm evolution ACR similar for Wanted cell for asset? engagers the at versus with a data T you see target how a less it efficacy. And immunologic just for products a for be this perhaps treatments CDXX the like profile, the type market whether to potential or intensive but

dynamics. XXXX then on And second the just the is question

said seem a get incorporated benefits assumptions And are your any sense wanted to not clarify in like to context. opportunities whether there increase I does around volume assumption? into that of or little IRA. be neutral, know neutral expect that volume a to potentially just are and pulls the better bit largely it to but I pushes hoping that sort of Just maybe you've it you of on

Samit, maybe you can to over start and then Adam. turn it

-- the X question. of me are Great And start there parts things. on Seamus. side let drug Thanks,

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year. study started remember Just of November we last our just the at We X end thing. --

in XXXX. was patient of actually First dosed November

few what are so severity they of to are data there disease enrolled and you as -- the to presentation we notice looking studies patients of data. the Number that who have who the may is And we that in things been enrolled that with. are that a want present one, are these forward

then for well on happens of stopping B course, to as of is loss they what the the cell cells profile. And of the then their And remission of or dynamics depletion terms immunosuppressants. treatment, treatment in on reemergence? were in the immunomodulators, after what cell what And impact B is of safety then, secondly, as B the that terms

these of underlying damage. many organ patients Remember, will have

be so And these look follow-up important additional number at with but mind additional be longer data. patients, data of that patients, to to you we These small in able keep even are indications. ASH again the update will as and at will

Second cell you as part how T of see your cost question was engagers these around do bispecifics. -- to

that and they report encouraging. the a using need CDXX promising, very look past. recently element out is we therapy, And have an and consider important will that's think T-cell well in case BCMA-directed there new I publications as come engager to for directed

patients at with should weeks. treatment. or to which therapies every the should administration of we'll a go because see bispecifics car engager define repeated which require have X future through weekly, We'll patients duration the weekly to then either on And by go point have T-cell and will a time, that in and cell bispecifics in to certain

answered T engagers. of to cell be questions are those So for all still

will multiple bispecific cell will have a of those in you couple theory a the out couple But T year, we BCMA recall diseases. application see You indications for myeloma. -- of in engager certainly that in BCMA-directed a studies next a in of we test starting Adam? that we study XXXX, stopped develop

Yes.

to to So the IRA. just benefit changes the the around design question relates it as

favorability So for we're by with XX%. that's going Eliquis to offset the due the with where the next gap. catastrophic like in phase, elimination redesign expect gap, we and largely products the now elimination with Revlimid POMALYST of responsible to year coverage of coverage But be the

also opportunities, pulls including changes are see net we affordability, Part the neutral portfolio. essentially So and there But D IRA with as pushes across patient design. in with taken together, benefit this our

from with The next question Blair. Phipps Matt William will come

program you moved how to view Abecma, XD for to be all GPRCXD opportunity enough wondering market is maybe CAR-T. CAR-T now challenge you trial, profile a do after given II a Phase second-line it really the BCMA BCMA would a Just the relative strong you've used the think Or into CAR-T? the

you what with Chris, going And type of are tonight?

with So as you chime we'll Adam, start can well. in and Samit,

Yes.

into III trials. moving that started we be with registrational study will quickly Phase agent the So, our CPRCXD

know. far -- is for great is to here seen think GPRCXD opportunity and we be company. with competitive we've what asset another environment the cell single that leading toxicity thus to treatment with profile with a encouraged with have is an very are asset really we our be CAR-T to thus be are seeing this this that a a dose we going asset after therapy important used BCMA we But We going Remember, far.

will question from Risinger come Partners. Leerink David with Next

to high-level I'll please. just keep X question, So it

the So royalty . on of the and call more mentioned times diabetes pressures you stream. revenue that, your sustainable that a Chris, company. a as you you growth on context growth Could see in expectations I the sustainable some just provide few Bristol-Myers think XXXX light end of

Star Yes. that the over consistently, short in David. we will the company a question, said long-term work CEO towards middle deliver stay end as have as with the our on North took since we shareholder November the of strong very our growth growth has execute as for way sustained focused that I exiting and term in building profile Thanks been the particularly the through of we a Look, decade. and value, decade

build to I we the things. that, say, that And way about as continue in highlight I confidence I'd think would X

of young portfolio we First, growing assets. have a

in that drive like results. seen profile. You've And very just in We've growth Cobenfi, focused the on its got launched we're in performance early this continuing life quarterly cycle. which to products squarely

Clearly, schizophrenia is important.

look a in adjunctive the the indications, discussed of And fact, You're remember, solid including GPRCXD. to additional therapy. CDXX Breyanzi show XXXX. we've and promising, pipeline that's assets notably growth going to in strong morning very of cell this indication see continues and that tip in at

and steady course, for would have extensions expect up line Those I-O our the X continued and of a next. subcu growth products We providing of considerably Optulag into talked in XX the business we've CAMZYOS. and saw next end through months. the We continue. about Reblozyl that decade to coming foundation nivo And for this

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we LPAX. multiple And that remember, that for have safety program. have programs and We're Phase excited efficacy II about demonstrated

multiple important and excited in play have Ibertimide us mesignomide And that over to XX months. myeloma. So the readouts out. that to see are opportunities next these products we're give XX

in late-stage the And businesses, So ability have us all That we've we've a balance of across then the financial pipeline. discipline. sheet. our solid got excitement to continued maintained gives

good, Our as example, the as for and acquisition, Karuna December. with flexibility both we P&L to did to us that internal externally continue source strategic looks program in in as well gives invest our innovation

in continue we're of the we build core looking the think company. if the add growth drive that to up, So for to I components conviction sustainable it how are I those

question come Next with will from Tewari Jefferies. Akash

your there them their team Merck guiding FDA here? is seem renegotiate and to branded which Given is on reps reports with your beyond a the team division, J&J subcu why your contract team regulatory to market on to seems be of be KEYTRUDA. for your to is Any any more that color conservative protection communicating what down doesn't shutting partnership Opdivo, for there's cardiometabolic subcu been around potential on

second question? the repeating mind you do So

protections length versus terms what of In is subcu around KEYTRUDA? duration Opdivo terms of subcu of the communicating in on Merck

it. Got

missed we just Sorry, that.

ongoing program. change be no engaged J&J good, relationship And in And they communicated, has our I'll So on partnership to J&J J&J. fact, we've very milvexian ask a with got the and Adam, second. respect that you continues very, J&J, squarely to Phase their continue program. supportive III the be and the in then work with on good on with programs to to very take

Yes.

Regarding the subcu.

December. is shifting planning look we XX% at we the of U.S. for can And total forward late which First, Launch do to ahead that in progressing we PDUFA late in is business, XX% least LOE, XXXX. about date subcu well. the the of Opdivo nivolumab talked to the very

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Bank. James come Deutsche will . from with question Shin Next

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Cancer. Olivia with question from come Brayer will Next

I you are of market adjunctive feedback Can you setting, set And data that mean a in think big next use year? because how looking off-label early guys when year early a you today's about do given around clarification see for making to to you XXXX, in a considering assume time talk from know adopters? that getting milvexian what you're it's any any uptake through realistically potential in that quick focus we it's update? just care. monotherapy I use but should think just wanted the of on on that could be ask standard I lines. still Also, later the potential

Adam ask the get we'll between those Samit X the for of questions, and Thanks Olivia. Maybe them. to questions

are Remember, that patients Thank the available agonist approval combinations treated are how with of antipsychotics DX today. are the without with in even space. Yes. being label, an treated in you. Olivia, this patients having

of important with to generate was the to safety background perspective profile showcase muscularis are it therapies from So efficacy the as combining the our data well patients as on. that

adjunctive be point that therapy, And what ARISE study program an is in an of the therapies. the side, That from will read out -- of a intent from On important, XXXX. clarification that's trial. the the milvexian perspective, perspective XXXX and on showing can will as Coventry deliver top event-driven end background the in the

So we we before. can't as guidance give you general XXXX give you why a within That's timing XXXX. a for specific terms the of in

Olivia, thanks.

efficacy get the ARISE to As important commercially adjunctive around adjunctive use Samit the talked the generate today, are though XX% to about adjunctive we're treatment, greater that believe treatment this. DXs not to for even be FDA on could approved an option. do X we study, working to of DXs and patients, relates XX% evidence and to it

adding X DX effects top and again, sense because, an we could makes it there of on pharmacologically, synergistic And MX a think there. be

see So we're excited to study the readout.

we And not readout the that as to for product. be product. important accelerators the growth the next well of safety really about focused of clear, be can't fee standard but not on Cobenfi to may choose of are there. may to because in to it's some for readout profile data But phymerpsychosis, patients though, off-label teams talked on-label our or we're use be these how as driving Just of use of Samit to make schizophrenia schizophrenia Juno choice, year in other our this going care data -- are going the excited

to put with we development continue this is this in but very line coming, that the I would it. on We've is obviously, we're a what really robust new excited And data will is adjunctive indication plan the a initial a just clinical product -- important, Adam for which generate that, super that got extensions about schizophrenia. that ended in product remind place is you

James. come Sean from Raymond question McCutchen Next with will

component speak parsed One of the Do targeted the you on be as relates patients deficits. to view kind or or what the expect cognitive in to in of more your monotherapy for setting MX driving have on atypical potentially of Can in improvements these setting? population it the you out to import the particular, proportion post

barriers about population is as GI And where behind what variable that looking are potential are on the significant lack your your regimen or you. of are compliance those a up adverse comments coming thereof and thinking in ease this use competitors BID at when patient that to effects

the then take Adam. and first will Samit part

MX a some the the is are Yes. as development Remember, Thank dual as they of be such it's you. ways feature brain. a the opposed indirect to modulators, agonist require because direct in to therapies that to differentiating Covent which target in present allosteric for that other ligand the

a cognition is very important brain. a biological the MX from And in because component associated perspective, is that with function

on having through think so during And we well Alzheimer's about as and the MX become gives cognition patients patient impact does us the as to quality the they impact as really important cognition the patient it, go disease direct as -- and impact on a life life. the terms opportunity and cycle, life of in MX that overall of

the and who drug. with be patients reads the if cognitive will eligible be positive large out a will treated there's proportion to So have of impairment data

as all why as recognition of Adam? psychosis that's overall, AD well in perspective. X from program impact parts So we've perspective, a agitation a developed perspective that

Yes.

cobenfi sedation. So regimen at about other dysfunction, efficacy, trouble cause areas step unsurpassed excessive -- is discontinuation. Number discontinuation and concentrating, like as for X efficacy areas it include efficacy of leading high-level talk that's include just to a the gain, the relates delivers good dosing of as weight and that back the and least

trade population. commonly than so People with physicians that higher at significantly rates general schizophrenia the managed And need living off. now don't to medications multiple

products. combat you when well events of existing which psychotropic a as schizophrenia, including they're with patients fact, as their includes pills look our on anti-depressants, different In day include at could medications antipsychotic. average to adverse medicines X the medications, It anti-anxiety

to that we're has but impact uptake that on based efficacy the we this unprecedented need this, So manage shown. yes, don't to going will believe

Last and thing caregivers both in we provide support with to I'd to efficacy the low is well trial that robust patients that very discontinuation will patients that the we fact and saw clinical is compliance mention product rates our due to times. maximize tolerated

know a I all space. morning busy have you in the

our brief So question, for then we'll closing turn it we'll to remarks. last take some Chris and

last Devarakonda will Crypta come The question Truist from Securities. with .

gears the today. switch a I'll on ask quarter about to and your not ask question. Congrats program. question I want test a

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thus really early to excited far And looking the the decade and what seen year then out. line in really see have reading We forward we but have time anticipate of -- when Phase is IIIs to specifically terms initiation. to the in have part of a don't next we

Yes.

this significantly the heat the affects people a far large is As is over the around and course to X that opportunity, where in of opportunity expected decade. as grow United States the million

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on we're So opportunity, what really seeing this with. a early and significant is we're pleased with

joining Maybe few the Adam. us the the the questions. Thanks, I'll performance very thoughts leave for you for everyone, for for thanks, today Well, on and call just thoughtful with quarter. a

execution. mentioned, -- from hopefully contributing First, benefit is as remain discussion, as Second, key from profile Karuna half you demand and our we now, revenue like growth on robust gotten very Covinfi a and products, transaction. nearly deliver The continues hard working We've David Breyanzi, been for we closed that have focused portfolio achievement. total to that pivotal of is the products Reblozyl, the approval the since to

growth important medicine the portfolio. patients, this And and for is for an important an it's driver

readouts of and beginning as the the few had continue as a more our have to advance areas. the we course therapeutic end between over several across now year, of Third, important next pipeline innovative of we and year. year We've well coming the

going on yielding And operational commitment gathered, driving across focused as then the to is excellence again, organization. value our finally, to and remain results, you hopefully we're

your is and for thanks the questions, So the of available great have team again a as for day. follow-up always, time today. And rest

now attending presentation. Thank is for conference today's you The concluded.

disconnect. now may You