Amgen (AMGN) 2 May 242024 Q1 Earnings call transcript

My name is Julianne, and I will be your conference facilitator today for Amgen's First Quarter 2024 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Thank you, Julianne. to quarter welcome earnings and afternoon, our XXXX first call. Good Gordon, and will performance by Murdo Peter lead Bradway be by Karnani Griffith. the Bradner, our Bob of call followed and review a Jay Vikram broader

the call. use financial will have appropriate measures, today, materials the and non-GAAP reconciliations performance course within of our that Through discussion provided we our describe accompany this

materially. harbor actual forward-looking also which are vary safe make results our that note some statements, to statement. will Bob. please We by And you, Over can qualified

potential Okay. Justin, joining reaching at we're see and our you, and exciting technologies. wet a harness the world and with Thank can our what's our redefining and existing thank and medicines, results, here callers us as medicines busy many of dry you more for Amgen. time late-stage mid- first-in-class is we pipeline advancing transformative in range you our to possible And patients research a as capabilities integrate lab today. in around This from and broad

touch from confidence few long-term that path a quarter highlights deliver growth. to the a we're on great that me give I'll on attractive

XX%; efforts integrate have leukemia. to into up With and grow. we plenty BLINCYTO, strong lines and have inflammation room up accelerate a momentum XX%; medicine, our products acute which number that general First, June up TEZSPIRE lymphoblastic across XX%; to we BLINCYTO, in was XX%. Repatha, These earlier oncology include of and up should still expect of an that approval for treatment EVENITY,

the TEZSPIRE's make new and very of obstructive pulmonary needed, potential we're are month world's reflect there. is attractive chronic this a later much excited of medicine this data share COPD cause treatments in to by death. third leading we'll potential difference that TEZSPIRE, With Clearly, disease. the

first-in-class significant sales pursuing early contributed markets. a for see disease, launches of in each. and/or ago. year Second, indications medicines cycle like geographic compared the We in for in formulations UPLIZNA with up $X TEPEZZA, and rare billion newest new pillar of we're upside these sales new And of products the KRYSTEXXA, growth, quarter, nearly potential XX% our life new from Tavneos.

we integration Union. our its and well, announced Verizon, approval to people, plans European the pipeline fit Overall, in for last reflecting example, an the of is between As products imminent strong file the our organizations. week proceeding TEPEZZA

our we Third, late-stage in pipeline, a advancing our promising all areas. medicines mid- X spanning are of new rapidly number therapeutic of and

is clinical and this We tumor. example, patients a look with are innovation engaging the to first demonstrate therapy significant for Tarlatimab bringing cell transformative awaiting approval tarlatimab, small to common for to T lung solid cancer. forward against cell activity

A lead. watershed pioneered in Amgen to field continues a and that moment

Phase the to we Looking trials. of from readouts III year, anticipate data rest the X

the in addition, to we upon sum, medicines range today hand the of decade strong us will and coming the around established of in of deliver patients to announced In In through end KEYTRUDA that the as build a leadership we and growth have have pipeline look and we beyond. biosimilars. of millions to enable we the biosimilar through today the world needs of meet development our global broad a

Now we in of II let that significant II Phase important trial, our conduct the for far we and we've normally the there are me especially analysis is provide thus very Phase this trial. additional data, seen interim update, we'll study results encouraged The today. and just for commentary add is comment with the complete, on with so whereas interest we and interim X recognize don't meritide, other obesity

unmet Following I will the we're in it confident say and important medical interim Maritime's would analysis, profile believe differentiated needs. address

then including and moving medicine potential carefully complete commercial II to obesity, this of as activities efficacy and Phase Phase in our planning a diabetes. with supply Obviously, broad III before actively appropriate ongoing expect We program safety clinical we trial well conditions obesity-related as are capacity III mind. further in trials. Phase both manufacturing as and expand initiated We've the to establish to swiftly

provide ongoing And protect you this that study ask the would few to not this before respect of expect further these beyond integrity data study. will remarks discuss we recognize to to with I a Jay the detail to additional would in update completion.

to want and business serve. turn over around Jay, for our you. I'll we As employees I world always, thank the to our patients to the to their it commitment

afternoon, good Thank everyone. you, Bob, and

Phase line Bob's remain been [indiscernible] XX-week ongoing me on track late far. pleased comments, Let very this study dropout top conduct and data the issue, with trial. for of an the reiterating XX overall arm Phase thus we are patient we're Alarms active, from pleased with start XXXX. Maritime, results not we're II in And the with very has II fully

Phase Phase diabetes next patients an to We're patients treatment regulators seeing Phase step III profile obesity, obesity. dose completing and and needs, from study to diabetes of II the trial with look insights working and indication unmet medical for a and are towards initiate the broad II obesity, year, program. additional obesity-related We confident address obesity differentiated diabetes and MariTide important it plan not with regulatory This conforms Phase without ongoing dedicated Later Phase new move dedicated step gating for the the the a II in we Phase our forward in maritime. requirements III II to of program with Maritime study schedule that will to diabetes. informed study, to III and for is the Phase is trial ongoing rapidly in the by conditions for this investigating

maritime portfolio, of those we assuming provide monthly a benefit administration, for device patient even that frequent convenient, less the medicines, deliver the prioritizing to single-injection are patients. experience, handheld, with or to greatest approval. stand expect to patient-friendly eventual Across terms presently In differentiated auto-injector we

assets. in profile MariTide and the in investing will a not differentially AMG Instead, pursue development. we're seen preclinical we've Given number with we of XXX, further obesity,

clinical or best-in-class first-in-class potentially Beyond MariTide, pipeline programs. our in of rapidly the advanced first quarter, diverse we

remainder leukemia June small in Looking XXXX to ahead, cell development PNUFA and time lung exciting promises cancer for adult as tarlatimab be Phase a of and in groundbreaking an research for windpoblastic well advance of our need. dates patients represent significant to data acute BLINCYTO treatments in X towards to III these deliver real readouts. with could X milestones mission the Each in as

to disease patients best-in-class the enrolled successfully of and cardiovascular XX.X across medicine, Olpasiran, both our Phase that RNA the community, in small just suffering months. are reflecting medical to cardiovascular patients we're Moving we targeting X,XXX of commitment of from outcomes interest strong the trial, pleased Lp(a) Olpasiran globe outcome to we've enrollment completed a announce OCEAN the potentially interfering III A study

to June starting an defined this outcome fastest deliver effective or targets risk with Lp(a) its exist. DLLX a a with size. capable we lung therapies a is tarlatimab, for for differentiated study delivering FDA our molecule And targeted continue elevated XX% enrolling therapies of conviction PDUFA To small knowledge the size currently on is first-in-class of cell targeting In remind, for approximately priority oncology, on a Phase high genetically to whom is factor, BITE which cancer. XX cardiovascular patients, track in with individuals date. review remain III large and no of for effect We

second observed tarlatimab first potentially we selective in a Based advancing about as patients for single receiving third-line cancer. frontline tarlatimab are cell and agent small excited remarkable therapy a on rapidly lung as therapy, We're draws our Phase activity in of the treatment and from stage both now with lower the initiated earlier tarlatimab burden, and rationale III The X disease. ALL. experience studies studying tumor limited in context in extensive for of stage BLINCYTO B-cell with the lines

of activity cell insight tarlatimab, an means survival eliminating We're build overall recurrent negative meaningfully hopeful in in cancer. we drivers cancer cancer disease improvement is lung the challenge facing residual finding patients. very and this would on provide small dramatic can directing evidence in improve the manner a cells, T in saw outcomes primarily cell patients that minimal patients which BLINCYTO we comparable early of aggressive are data These There, disease. residual where the this for with of effective this stage

potential as bispecific our the cell T-cell first In sum, tarlatimab a engager T a broad to major engager common tumor, platform. is efficacy demonstrate the of we regard in establishing solid further bispecific advance

bispecific solid to advance tumor, I the demonstrated of continues prostate a encouraging [indiscernible] presentation also alloritamac first-in-class cancer, has following Phase in namely Our the activity an ambiguous data fall. molecules last

dose We I have Phase patients enrolled to monitoring and expansion the continue and reduced now cohorts. monotherapy in enroll fully outpatient

and hormonal Further, with plans cohorts. therapies combination initiate novel studies near-term with are to escalation studies expansion dose dose [indiscernible] in progressing

which we inhibitor severe AMG XXX, I additional portfolio, dose with our are advancing have rapidly by oral We've PRMTX studies Phase cancers, tumors MTAP the investigated tumors. thoracic, pancreatic are our and with in monotherapy patients of we moved all tract oncology, In Phase proof-of-concept null initiated X moderate IIa forward and biliary expansion COPD. solid with explore targeting studies combinations MTAP out targeting results TEDSpire the round course very to inflammation care. study, in standard relevant encouraged gastrointestinal, of To

designed test bronchitis drivers levels, inflammatory status. emphysema, study chronic smoking intentionally of This irrespective to range of inhibition across TSLP was an broad eosinophil and

significance a While patient fell XX% of demographic. reduction broad in this exacerbations to likely clinically annualized moderate of Test result rate placebo, statistical or COPD meaningful Bayer achieved short to overall compared the severe owing the

number for cells of were greater a exacerbations blood even per further baseline a than with XXX eosinophil observed XXX. planned counts than However, subjects with in patients with baseline reductions a greater of reduction COPD in trend small [indiscernible] in greater counts microliter

we We're III the later partner, Together be AstraZeneca, Society of excited which oral in planning by development for are with [indiscernible] Annual session Phase an American of this COPD. these actively month. Thoracic will presented Meeting our data,

half to in Beyond continue and separate of expected second eosinophilic COPD, where rinocitasitis the III nasal chronic in top are this in data we line year. with polyps, esophagitis studies explore Phase TEZSPIRE

severe The are [indiscernible] ROCKET on readout of III X,XXX antibody X for monoclonal year. with in X and Indeed, successfully Phase data Phase study to over of patients studies The second to evaluates adults this placebo anti-OXXX severe of study, this III rocutinlmamab rocatinlumab monotherapy with Rocket atopic top moderate now a remains enrolled. rocatinlumab, has fully HORIZON dermatitis enrolled half the in first-in-class program the line the program part track in dermatitis. atopic versus program moderate for

the this opportunities. Phase initiated with need to half of advancements Beyond year. Aplisma, moderate our in as anticipate in Phase in potential asthma to and rare disease several indications well unmet diseases make a with Starting readouts gravis severe disease, difference patients. this atopic significant second the where We're study, a mid- and important both of Phase to initiate [indiscernible] to III dermatitis, in we have II pipeline study encouraged late-stage a we real with to explore myasthenia for plans with continue nodularis data the year by rocatinlumab in additional have III we IgGX-related broadly

has entered disease disease with follows population. III in patients. protein encouraging fusion demonstrate innovative severe This with patients with inhibitor an Phase for the therapy II patient Dazodalibep Gasodalibet, now high enrolling across patients CDXX data ligand Phase moderate X the latter efficacy systemic is symptom studies burden. Sjogren’s efficacy with to and first to

portfolio, in XXX, our ABP biosimilar pleased initiated also of to non-small study metastatic KEYTRUDA announce we've advanced candidates to cancer. CHMP candidate biosimilar lung Lastly, subjects a positive STELARA a our Phase or has WIZLANA, We're with III biosimilars non-squamous to in cell opinion. received a that

now the serious portfolio like medicines. Murdo. to both closing, to and first-in-class the for patients business research it our our of I'll facing growing commitment best-in-class of Amgen I'd of and and to colleagues, their And illness potential service over strong say to In my our to turn sense impact

quarter. in therapeutic growth pillars our [indiscernible], [indiscernible], of Thanks, volume XX% sales across execution year-over-year, our and growth Jay. at across growth growth, with with our Repatha, regions compelling including least first with TEZSPIRE, in Strong pleased business. of volume the the BLINCYTO. XX performance delivering products robust I'm drove X We resulted double-digit

of generating well integration Horizon $XXX million quarter. the portfolio to legacy progress in business Our the that continues with

saw our business, $XXX year-over-year quarter, for of Repatha, Prolia, million the general [indiscernible] in sales in XX% record XX% Sales to EVENITY driven Repatha grew business. medicines In the net way a and first first increased multibillion-dollar with quarter, including on by we becoming year-over-year and now year-over-year growth. volume partially XX% is XX%, the offset Repatha volume to price. growth of its well quarter, selling a lower

volume expand support rebates accelerated for net Expanded partially formulary offset by has and from price resulting lower This coverage U.S. higher was for Repatha in patients. access to the selling growth.

primary care removal We requirements several lead increased expect the by payers with of along this to prior formulary and adoption. expanded will authorization cardiologists coverage, physician

of are growth EVENITY U.S., helping delivered be with was the sales by had expansion who supported in the growth bone a it. more we we combat even fracture to And remain continues EVENITY, with EVENITY risk And segment at XX% volume Outside their experience market. continue who see the while of osteoporosis. growth reaches many million to bone-builder postmenopausal there quarter, and the in prescribers. an Evenity happy of to their patients for due reduce potential also risk. and strong of of health record we'll we're for apply ensure U.S., $XXX proven EVENITY cardiovascular the growth, risk In patients the EVENITY Japan, leader to the this all women need to our exciting

our Prolia quarter. evidence, reducing compared OTEZLA new volume was postmenopausal treatment-naive we fracture by business, patients for X% high In Change the reaffirming saw U.S., at be inflammation trying the increased year-over-year growth sales alendronate created sales osteoporosis, growth risk to who in March year-over-year. supported to disrupted are Volume for at real-world X% issue, grew when and Prolia risk and specialty continues prescriptions patients superiority challenges fracture. in pharmacies. February the by which some of in the first Healthcare This to fill quarter. strong early In patient cybersecurity with

we've safety of efforts OTEZLA of and We've investment in significant given see ease and to of established focusing payer field on for importance We profile of potential, Otezla. safety psoriasis to course, force potential patients growth the physicians in on administration. its and realize limited and treating our with efficacy accelerating increased recent new direct-to-consumer educate authorization Excellent the patient efficacy profile. To prior return seen systemically and coverage this and, prescription weeks. a requirements of growth OTEZLA, dermatology future media,

of phototherapy volume I'm for that for sales therapy. to with are OTEZLA. approved by FDA is decline, and for exclusivity higher the and pediatric also This inventory age was psoriasis Enbrel partially offset first first driven systemic moderate treatment of pleased OTEZLA years pediatric X% older the year-over-year plaque for granted severe candidates patients recently or by the the quarter, X pediatric who decreased indication by levels.

forward, Moving net by declining we offset modest expect growth volume price. selling

Sales with single-use sales in business, of our driven of health strong Tania apneas million quarter. disease more XX% driven continues increased quarter. primarily trajectory were $XX the increased in professionals. U.S., have sales Sales by pen. buyer $XXX volume treated with X,XXX by year-over-year XXX% than over its the In uptake been Test million rare first in the the In first patients X,XXX year-over-year, prefilled care growth. by now

vasculitis. to continue Looking leverage in forward, bring expertise even and more inflammation to nephrology to our we'll [indiscernible] patients with ANCA-associated

Sales with offset for the and quarter, grew XX% inventory price biosimilars lower portfolio for selling our partially growth, by first decline. volume levels year-over-year net

growth of grew the We launches. expect In LUMAKRAS, Nplate our quarter, X growth. additional XGEVA molecules be our and [indiscernible] business driven first KYPROLIS, biosimilars in by for of addition products, and innovative sales to new X% the volume continued year-over-year by driven BLINCYTO, oncology,

patients community across a year-over-year June Drug XX% quarter, grew academic sales a prescribing acute has first and BLINCYTO PDUFA and with broad early-stage a potential B-cell for million. year-over-year year sales as its ALL. on approving this to BLINCYTO a for decision quarter see from for utilization first frontline Blincyto growth with XX% record in significant CDXX-positive, B-cell U.S. precursor of by Administration lymphoblastic million The $XXX of for to Food treatment. segments set We the date leukemia. for driven for record increased LUMAKRAS XX the $XX patients treatment

for new to exchange sales and offset X% future for unfavorable growth record $XXX see markets launches grew to of and XX% quarter, growth, growth End U.S. driven driven which opportunities by by higher Electric plate million. primarily driven primarily by Lumicast a price million the decreased quarter sales X% volume outside selling of impact. in first a from quarter, coming government first in year-over-year indications. by decline U.S. order year-over-year, sales volume Kyprolis increased the net foreign for year-over-year first comparison the We volume additional the $XX included XXXX, partially

year-over-year. we execution the across world around who I'm Nplate our order, more and of and grew momentum many serving over from therapies. I'll XXXX to in sales look that, Vikram. pillars turn And it with the with forward our the our the X can the patients government U.S. innovative QX XX% quarter Excluding pleased benefit to business

to Murdo. therapeutic Beginning growth QX. of growth, with which an sales pillar to I [indiscernible] results when in TED, provide Andre's reflecting on million from Horizon treatment or of legacy disease, compared sales year-over-year product pleased rare the fourth you, million, X% am update $XXX were Thank of the disease. $XXX TEPEZZA quarter for business. delivered thyroid of over First

or few activities clinical often low high a symptoms, different and Disease number the to and discussed we and or using terms Investor CAP, activity of which As refer high clinical TED and signs redness, now is back, including months score, pain, in TED for our swelling -- low we meeting a covers of and assessed Rare at function cash.

patients For TED could the XXX,XXX TEPEZZA. in from U.S. the approximately who benefit

of are majority these roughly settings. The in low cash patients, XX%,

appropriately We number focus cash large patients low of not treated. being this to on continue

As to patient of patients and we U.S. setting one hurdles challenge, we in this previously is this XX% discussed, have expect of help the policy greater for continue XXXX. that momentum than throughout To we changes overcome access. in main the lives, favorable covered generated journey medical

we often underestimated. expanding impact new who endocrinologists prescribers, many of quality and particularly among our The are ophthalmologists life low manage reach of TED In cash addition, on patients. is

health the care less So our about visible significant is focus with symptoms. patients, those on effects educating providers on even

increasing popular addition force space. dedicated on endocrinology surgeons in engage this a in our In and and are focus to important sales educating we ophthalmologists, creating to focus our strategic

Brazil in International and long-term a meaningful TEPEZZA, is Arabia. expansion approved Saudi which for currently remains opportunity growth

and trial in low CAS filed for approval in CAS As to is enroll. in a our January, III continuing Japan high Phase reminder, we

the an and with regulatory Medicines an recently and and Canada, Great additional our this Agency. sales growth option Australia, with We as chronic current to Britain refractory from year-over-year submissions the III QX, strong improve Phase to gout We $XXX delivered opportunity by have increase formulation. growth. representing subcutaneous study adoption XX% patient most with initiated alternative execution. volume a European IV in in in experience million see for patients KRYSTEXXA driven commercial completed

U.S. in also the XX% QX, is expansion markets NMOSD $XX million UPLIZNA record this of fastest-growing including Horizon January ex in sales leadership in in Canada, biologic and launched launched representing global UPLIZNA, leverage in inflammation, a year-over-year International multiple growth. now on with net underway process the which The be development as manufacturing extensive we Amgen's track in continues legacy to of business year. integration footprint. lower-class delivered and

Now Peter for our I it will pass update. over financial to

our Thank and you, XXXX with to performance on long-term our goals meet and Vikram. We're track pleased objectives. full

Our of products, in-market quarter globe. our results which our and is growth By innovative review with pipeline outlook . discussing guidance. XXXX serve first our across driven patients illnesses each before pillars. therapeutic around portfolio serious strong the our I'll X

slide on and XX acquired Blincyto. delivered in million $X.X a This increase year-over-year. also shown XX% first $XXX Evenity, the TEZSPIRE, reflects of growth. from Slide As the Horizon XX% billion key revenue, over products including including we in deck, volume and total Repatha, quarter, Prolia brands,

product driven addition the by growth. Horizon, X% volume year-over-year, sales of Excluding X% increased

with medicines, rocutinlumab, investments expenses MariTide by in along Our and including non-GAAP pipeline Tarlatamab. products, XX%, operating rose acquired reflecting other late-stage Horizon

quarter As the our our earnings was guidance operating call. a QX fourth consistent margin on result, with XX%,

up for from issued $XXX million interest entirely repurchases. Horizon expense, to almost income due OI&E the higher resulted debt partially interest year-over-year, $XXX offset gains acquisition, by and expense from in debt non-GAAP million Our increased

by planned billion cash our previous deposit impacted on $XXX [indiscernible] decrease in interest change in in a the items due year-over-year quarter, X.X on XX.X%, flow, Our first free uncertain the we as quarter. the and fourth from rate year, a million tax the accrual stop quarter of earnings favorable of the decreased business, positions generated percentage discussed In to billion the the the inclusion tax earnings $X.X the company $X.X non-GAAP call. primarily points Horizon primarily in to tax to mix, to net

on prepare a synergy As legal X position year. our track, offset by trial expect Horizon to belief of the later cash in by year flow this there post target on items. capital for is The partially our reminder, free in and as timing our was pretax million we no the we $XXX of integration reach change working impact This is acquisition. merits

roughly EPS year we rate we annual execute We run achieve also of by in of target to to this flow the our cash expect non-GAAP anticipate XX% maintaining expect to synergy plan. end while our accretion this strong XXXX, XXXX on and generation deleveraging continue and

To and to value fair our XXXX. achieve pre-acquisition allocation track ratio, structure capital the remain on capital multiple investments, of value, adjustment efficient remain end to return our including acquisition-related we noncash -- the for costs. equity We pre-acquisition normalized leverage market of by other priorities. certain items, to We committed Horizon

MariTide, investing We late-stage the innovation, spending continue externally. internally including both to rocatinlimab. With and programs, prioritize increased on and in bemarituzumab, best Olpasiran,

continue we in including investing manufacturing facilities. Second, in state-of-the-art our long-term our business expanding growth, for capacity

Carolina and be in expected site quarter to is efficiencies. first boost operational extensive We the to North operational artificial robotics intelligence and Our Ohio and utilizing Amgen, XXXX. is by opened

integrating development actively across streamline AI the commitment innovative innovation effectively. technology in more and us to to strategic enhance enterprise our This and care the enables advancement, reinforce to patient industry. drug lead spearhead We're generative leadership

that in to capital represented returned of each of paid quarter. This share a X% we increase per first $X.XX dividends X quarters. over as we Finally, shareholders XXXX's the in paid

for Turning for on the business the to XXXX outlook Slide XX.

$XX.X and anticipate in earnings We range of XXXX $XX.XX. share the XXXX. $XX a revenues the considerations to between you billion model remainder expect mention as per our I'll of and billion $XX.X few non-GAAP total

based investments by expenses our [indiscernible] our R&D to We're XX% making late-stage approximately our increase Our prior pipeline. XX% are expected year-over-year in versus confidence on roughly year-over-year. guidance incremental non-GAAP

first medicines, XXXX rate III grow non-GAAP and October PDUFA expense quarter investment expenses year. supporting and our focusing accelerating fourth to third quarter. Total on and comparable quarter Phase operating in dates normalize X the the are at in with our fourth including advancing of will for rate MariTide. to best-in-class potentially a comparable scheduled The first-in-class pipeline, R&D Horizon commitment the innovation, X reflects early XXXX. over readouts Our since data second multiple base June to a quarters the completed transaction expected the throughout

continue quarters. will anticipate over improve our to We X operating the margin next

to billion, Horizon debt raised which the of interest acquisition. roughly the OI&E expect the be $X.X for We related billion expense includes to $XX

be non-GAAP mix the the primarily rate tax expect to favorable with benefits includes to full in range business. of year which being XX% a the We of XX%, by the of income, jurisdictional inclusion Horizon more the driven associated

expenditures We've capital unchanged further remains guidance initiated Our at approximately capacity activities MariTide. $X.X for billion manufacturing XXXX. to in expand

We in $XXX year of sales million. full project last approximately

robust. XX,XXX-plus long-term dedication grateful to for our Our outlook remains I am worldwide patients. serving colleagues to their

our So it to I'll financial now Q&A back session. update. for the this hand Bob concludes

Okay. Thank obviously, that a lot for we here. a And we're you out me before ways can just Julianne, we let exciting line, of difference excited have patients. the you, about open the Peter. And we point opportunities think make

of plans ongoing that provided interest, we to update the again, II would this the study. obesity, of and our we're significant there's in of the completing recognize we you terms reiterate, focused integrity just I today's in apprised successfully maintaining on Phase In and keep opportunity But area.

callers on our turn to asking have process be for of in mind, we're in But that mind in remind So the what going our beyond and with can we delivered say Q&A, bear just limited in we've MariTide. prepared Julianne, remarks that maybe you what questions. as already to we obesity could very to

question comes Richter Sachs. [Operator Instructions] from Salveen Goldman from Our first

trial move of given us board. forward you can you the to were Phase here, kind MariTide here, program confident what likely to remind but here II learn the III just the you enabled to and that with Phase on looking get in the On -- just did

don't question. in, jump Sure. Jay? you the Salveen, thanks for Why

will Thanks, about well-designed medicine for encourage III Phase investigation. really a in dosed Salveen, a II study how that we're And also teach it's seeing aggregate Phase from us study, benefiting a and these and profile best that this can Yes. question. received. and we're Look, differentiated from . broad data clinical lot a and a guide your and well-executed

Our comes Jefferies. from next Michael from question Yee

update. And I appreciate the

we think I all do.

all comfortable, or interim ease clarify metrics, feel highest including at concerns? the say looked all date. was of looked including Is you safe your that bone safety to it to and that to at and to investor Just and any doses doses

is Thanks as Michael. a well. This with an ongoing a study, very again, a this lot, I'll that's well-designed take one study well-executed study. replete measurements. and

avoid have we and an inadvertent bias or to careful be So introducing to unblinding.

comment well individual And but results Phase just program. We're the pleased can't we the II. on as we're so moving with rapidly characteristics, forward III to diabetes very with as the date. Phase

I haven't we with dropout reiterate date. active, and had the issue remain all that patient arms would an to

I think, study, we again, that it's reviewed sure you Michael, carefully. as Jay be and can said, a data well-designed the .

question Our comes Terence from Morgan from Stanley. next Flynn

and dosing areas seeing in MariTide it's efficacy, of on say. interval. clearly mentioned profile, you're about think you Jay, recognize tolerability differentiated Great. limited what can you we differentiation, But as

if which it you're differentiated And what those can on then of are you looking tirzepatide, benchmark on? comment semaglutide, both of Is wondering you those? just So areas to?

maybe, you the if jump get there's want then, desire Murdo. Again, to you to into Terence. appropriate But can we the Jay, differentiation. feel elaborate can after on, to to speak Murdo, appreciate Thanks, do detail. And you competitive anything in that

broader we Terence. question, also Thanks that Bob. Obviously, products we're very feel program. our III for and to watching MariTide in very to and our closely as the have this as products for Phase we we're being developed . the in differentiated continue at consider development to with Thanks are looking II Phase in broad the Yes. and ability differentiation. clinic in-market profile respect And confident we develop a

actions in We work very follow Phase themselves program. a think dynamic very the area. development Yes. I'd this just And closely. at Terence for I obesity were add, very hard a planning of speak comprehensive taking and competitive is we're this exciting, -- . case, medicines III the

Olson from from Jay Our Oppenheimer. next comes question

the all then and talk thanks Maybe behind the launch and launch for you the with potential approaching. about you're clinical in work on for line bit and rapidly tarlatamab? profile prepare to update. the Congrats just progress gears a late just providing expanding work little Can the for to Tarlatamab shift to strategy launch doing behind go potential and to initial the that and commercial the the the

talk pieces. thinking clinical launch. take on let's Murdo, development this. can that you I'm And the sure, Yes, for about elaborate like maybe, in X Jay, to the of And you'd then the

thank question any diagnosis deliver lot one benefit I is treatments in on very, cancer, lung you another cells. will durable patients that with in for exciting little which difficult highly response that portfolio, cell the think effective our in very kind a for a Jay, very with small product small of deliver Sure. the of of way

So approval FDA, we we're field our and for their organizations, anxiously from including prepared the have we're are all field and across our prepared. but well been trained teams time medical some are awaiting personnel,

clear have very We approval. physicians very post reach to order short in treating plans

is just for and in frankly, it's can very but setting broad we We approved. it's about And making really where, single-digit moment, we the have a for patients understanding of dismal quite of very survival sure important a when feel lung good Amgen, late-stage this. a to months. clear This that provide access the small really cancer with cell of the is matter tarlatumab not treatment

hour, we're minute, any that. our day And here so planning and we in wasting not a or to do any opportunity have to huge impact, any

chemotherapy the mid-XXs [indiscernible] evolved highlighting in with this agents immuno-oncology disease for to medicine, PD-LX a thanks today. meaningful oncologist since upfront really Jay, the not therapy of and with advance And major this which benefit consider an treatment but of the incremental has meaningfully potential we

enough this of where get time so the move therapy. fast this case just is earlier medicine And into to lines can't

I'll studies. of briefly. so give have And asked, architecture III And initiated we . X an Phase you just them as

to standard compare will We employment dedicated that with the them want this get care tested that to a chance have as is really therapy. this primary many of and quickly overall know, must Tarlatamab and medicine therapy, so is study chemotherapy. third-line frontline patients in of receive second great study to second And line enrolling. a patients a never of progress the where, reached survival, We in you this of

will of study therapy limited trials, the small extensive cell for small contribution a lung in following upfront one tarlatimab response. cancer for of pair so immediately cancer one stage cell and with lung And stage

they learned front line. the course work treatment development there we've a best with as into disease these has when of move is a work We've also that low possible the we as that been they're they disease. given case for BiTE the learned ALL of in when early And as best that molecules through of burden

medicine this been And earlier so the studies patient bring hope and design great I'll there's III of to intense this X these say lines. Phase community. in interest therapy And will

studies And enroll so we expect expeditiously. to these

please? next Julianne, question,

from question Mohit next Wells Our comes from Fargo. Bansal

you of you manufacturing us how expecting as Could dip of the have the complexity is be on a question I kind well terms the help what this or simpler investment as And think understand traditional should AMG journey. based XXX. do as you as it go cost? complicated versus -- of regarding in we [indiscernible] you embark

manufacturing Mohit, the front. I don't development think the we're challenge intimidated on the about process or

a as therapy in know, I you think, again, this world manufacturing. on is backbone. we've antibody established firmly a based that's ourselves as And biotherapeutic leader

now fairway right us. it's and in that's of on it medicines, We've who market this lost maintain not these found I'm patients the difficult the not loss are either. that have us the So sure in to the supply competitors down of middle for

determined do patient, our time tradition to we're that best of And the supplying sure marketplace. we to uphold make long every every our in

that. -- the think patient, being time. able address. technical as record of I fairway And in the terms that challenges we track to of is down do this every look of again, middle said, the we to We think need we our forward every again, to So maintaining that

terms capital address road. down question time, the opportunity a over from But as it require imminently. as and the obviously, becomes and the for embraces that, our that expenditure for his commercial that we'll Peter to the guidance said meaningful, will us of ready that remarks, have clinical we we the year extent about to the have underway challenge what make In ourselves to it see your activity

comes Umer Evercore question next Our from ISI. from Raffat

X I modeling But I have. single you which side, worth device? million, then injection. obviously But much One, knowing will something And mentioned a million trial. is ongoing CapEx this. manufacturing can from million aim capacity of capacity. is your and on patients how to -- or a ask capacity your pen on perspective, curious, curiosities million a I'm my to from all have X imagine it's a you to X spare I'll relevant, pen experience be it is manufacturing it the is know would secondly, it patient-friendly device this is handheld auto-injector, guys a else? you or a XX

Yes.

think more I about point. the don't going anything we're this say device Umer, delivery to So at expected

think very we need our the differentiated patients as position quantity be of that recognize think profile to want will and be be could is large, clear unmet respect of serve, that and that in patient-friendly With a to will in it to be medicine. were we supply to we expect the the we convenient. interested the we here as we think that we I patients

with I therapeutics. out today patients millions you're point the I serving hope aware already our would you, we to are around bio that globe of

So therapies. millions many antibody-based again, patients supplying to we're used of with

on think X I million pushing worldwide. up we're Prolia now right patients

and takes that quantities therapy. sure therapies means delivery be understand competitors you that fewer less we devices likely far of not on is I'm that injection of large And a it frequently example, So lost antibody are schedule for the devices. successful what it's with supply than all to what to the it to as fact delivery administering implies or dosing weekly said, who, monthly do Jay

as be you challenge. all I we'll on reasons hope in confident the recognize the recognize that for all, why questions reasons to up we're supply, So again, your but we that well

Gregory RBC from Renza Capital comes question from next Markets. Our

now as I'm oral MariTide strategy oral obesity levered the on the you XXX. portfolio updates your options on about curious thinking And options and certainly term. And assets. with convenience, within you cardio metabolic your speak how efforts Congrats are news just lead are with the portfolio to fit how MariTide the as a that towards should longer in as on well. on you question larger just

differentiated for have of And And profile do medicines. medicines the Yes, We of some work on assets. strong some and for the of bar This -- base, Amgen diversity that as pipeline, as believe types profiles, obesity our for really a far obesity profile nonincreasing hard different meet oral. seeing with that that. that Maratide Gregory, the the need are the we're of all different raises marketplace obesity-related with we and honestly, heterogeneity, well thank and in medicines They're pipeline you. are the earlier that will demands conditions XXX and the a injectable at patients increasing we are just assessment. not did

from Wolfe from next comes Our question Anderson Research. Tim

ask based differentiation the think should a past question in us differentiating I MariTide, can answer, you I'll you on that would is, what what on the showed. I which to be able On be remind felt Phase you

I'm just So you on frequent that the data what on but less felt just to what dosing comment show past seemed is of front, course, what reminder asking saw, but you a one, not comments obvious you in frequency, recently the else? of to

the forward. profile to be with is think we a think good these of Yes. believe with and a and on Tim, market by as what of we number we we've the and the differentiated broad been interim able product, consistent opportunity that to differentiated we MariTide on analysis for mean, opportunity move we continue as a fronts, a believe I millions and to see patients we of both past medical in a that have unmet obviously, to address fairly in I really an access needs we that, differentiate opportunity results, to will the establish market, into go MariTide broad differentiate as provide

question Yaron Werber Cowen. Our TD from next from comes

Congrats on the update.

is just titration technical question In that because just you there interim or analysis dose then I'm was to on answer it the So a going in for ask . And can Mirati, nature. not blinded? little in it's blinded study. a a remind us,

Jay. thank see interim analysis, to as This the the to assigned Sure. had The to participants ability blinded study. of R&D treatment the this arms you. an But is is have the -- analysis importantly, of we integrity preserve to leaders investigators [indiscernible] interim and study.

Meacham comes Jeff Our of from next from question America. Bank

the for question. Thanks

one MariTide. You have another on

expanding a the tolerability picture better portfolio obesity, Just just obviously, focus, cardio given that any do you of program Amgen's thoughts updated and beyond safety the recognizing on have and have now and you profile. diabetes

we're as obesity diabetes a work needs Yes. in Thank intended a to in development obesity-related program we number heard observing with and for and preparing in broad continues can a we're you the you, asking that of MariTide III address -- Jeff, at the MariTide as And pace what clarification. Phase and allowing What for of for conditions. well. unmet

Capital Seigerman BMO from Evan from question comes Markets. next Our

ask so the say, I'm ROCKET And I although on on us see? not the in ask you entrenched is DUPIXENT going I to Horizon to dermatitis differentiation position this attempted space. would actually the can what you atopic want to is talk Rocatinlimab, want upcoming, MariTide, asset the to. with how one to study versus, just and you RINVOQ

it's you Jay on positioning address in pieces, Murdo think differentiation. And extent how can Two maybe to the can to the on jump it. about perspective appropriate, clinical then

Rocatinlimab know, Yes. as strong It and But close even directed [indiscernible] you [indiscernible]. though work. to sounds as IgGX, this you're OXXX antibody, monoclonal

called a patients X,XXX has Rocket that over program We have enrolled.

dermatitis trial. It's going horizon, here to And to Phase maybe weeks case, XX-week so-called address limit controlled to that in It's atopic this I'm dermatitis. scope enrolled. a treatment space. to And the in III X with moderate severe it's so randomized placebo differentiation, against actually study. readout. patients And XXX atopic in rocetinlumab the the It's HORIZON every

XX weeks. have at We endpoints and XX

hope -- . competitive tolerability. to and atopic efficacy and We oranges profile always very expect and observe trials, dermatitis, it's a between strong patient excellent experience will to moderate we apples to to but to with observe in compare severe

and and you its leave how about I Dupixent to closely, Murdo we to through differentiation. Here, that follow work think about it to think talk in development

the And Jay. for Thanks, Yes. Evan. thanks question,

as Jay mentioned, broad population in a studying, are patients We dermatitis. atopic of

biologic will as well we previous bio have patients experience have some that will So naive. as

in this the to in how perhaps recent the would I how against different So market. [indiscernible] and differentiated a mechanism. indication using we we position I highly use differentiated would product effectively a know -- of test launched experience will DUPIXENT just

alternatives And this in and the to area looking patients to prescribers bio-naive the fact patients. is nonresponsive are for

data trials. await and have the to good but we here, opportunity about the obviously, see [indiscernible] we So feel clinical

comes Our from Chris from JPMorgan. next Schott question

post Can compound I this to do as Phase Phase we just that you role you COPD the TEZSPIRE Phase more in part program. data of efficacy how the saw bit a [indiscernible] broadly guess elaborate across different maybe and and expect III, potential study its the that, in II on little the II given in

It's Thanks Jay the again. Chris. question, Yes. for

Society And so as in the Meeting later Phase presented presentation, II Thoracic I mentioned, will oral be American COPD this an month. the at data

natural they will to as its you remind this alarm called TSLP there family share. that abstract just And that limit of asked are what is it I'm But do. presently a do what from sounds more as ins. what like I embargo, or to so is mechanistically comes And what work at able they

is The strong investigation. we more why is heterogeneous that COPD invoke participate often or An type a disease irritated than inflammation. as that's asthma, that that's much type And X you inflamed eosinophils. called involving But this as triggers also then epithelium, response know, for type COPD, in it There cell inflamed in or milieu a of is TSLP signaling X X measurement must inflammation. are then clinical in factors asthma. what's but TSLP as activated releases converge rationale inflammatory in for and T down number

was so the this of stratifications design which this XXX per and cells that built and threshold one understood microliter. of of appreciated into it for trial clinical And eosinophil predefined some analysis,

the to sharing And data. forward so full we look

that We molecule have of controlled randomized in trial. the this activity clinically meaningful already there's disclosed

more [indiscernible]. expect at so please And the

You asked about the more broad development.

that characterized are You as rhinosinusitis molecularly polos. X interest is TSLP epithelial And epithelium feature inflammation. inflamed with surfaces an eosinophilic airway are a esophagitis well. other type right nasal as in of these to of diseases develop Hence, it chronic well not our by as but both only

Shin James Our from next Deutsche from comes question Bank.

your It's reservation, on just that. thoughts off it's CDX the This one XXX, on a EGFR get for little Jay AMG and oncology. for bit is wanted -- to the

some be from up recently going out coming data there's to come some think soon, that's data and I peers. there's other

I Well, question. for Yes. Thanks James. the would say this,

and moment. to to is We activation of the learned cell at of over tune surface news no the And the with engagement have potency to bispecifics. we to CDX of of engagement there antigen share have experience time the a degree developing this And you large CDX.

study solid engaging tumor other by this bispecifics buoyed and tarlatimab We the the T-cell from [indiscernible]. to . guidance and confidence continue really targeting and

I bispecific as would on solid in other medicine So as well targeting T-cell that the tumor expect more future engagers.

question next Kripa comes Our from from Securities. Truist [indiscernible]

the question is you please a program? where I Can think you III have on I are ongoing. subcu Phase talk [indiscernible]. about this with

a about And to concerns of that impact what patients with little bit on treat Just And having hearing uptake? Ted, update more are any on safety that. you you as continue around is concerns?

parts. want take Well, in marketplace the to the can Vikram, Jay, that you any on extent clinical X address let's you share to it then thoughts the questions in. jump and

The question. R&D the of for the program. administration major thanks Amgen Yes, development subcutaneous in priority a TEPEZZA of for is a

in This severe clinical studies date. if to design a is Phase TED. will Vikram, And And the we label-enabling with already active akin is what study. We have you to speak completed initiated this intravenous to to want to the be -- have experience. III moderate reported

think -- I so thanks for question. Yes, the

or hearing is loss. loss if AEs maybe that imagine, the about I think around was hearing growth. [indiscernible], to and question I that you And specifically referring limiting

getting at we top. all start treats let's pretty it know involved be a which TED, very in debilitating is So the effectively TEPEZZA, we severe and disease. function. now IGF-X, as hearing

section looked carefully important to this for used experience the any we for and at have very monitoring. should the who development warning be assessment along assessment hearing now assessed -- precautions any we So with specific have patients the and clinical [indiscernible] monitored -- TEPEZZA of included It's with PI, during impairment. because of -- function. We the in hearing and recommendation we

this understand So with to be profile standardize this not many for of getting increase to label has education. also do generally societies hearing favorable baseline We're this of okay? assessment, risk-benefit a as help in professional TEPEZZA. the management through turned barrier a And with after physicians physicians while generally HCPs, growth. the use the it working working approach,

Thank you.

we point have queue. up hour still pushing of we're in But bottom the Julianne, here. to the questions the So a few

his any If to take couple let's questions. we more will around to try these we'll don't we So and . through Julianne. But to click this everybody, questions. obviously, and Justin to your try through get quickly, answer evening team be get can a ones

Schmidt comes question next Guggenheim from from Michael Partners. Our

has commercial I one gained on recently. some was last reported recently there showing some academic Medicine momentum which And week had data RA. BLINCYTO, activity Nature interesting in some in

developing about And are Or you so just [indiscernible] how have you maybe plans? potentially wondering or if [indiscernible]. was I thinking any

Sorry, disorders? in autoimmune

Yes.

And cell rheumatoid T more work recently, with exciting here And With Yes. that's CAR autoimmunity, systemic in very therapeutics deep from arthritis see. expertise committed to Thanks evidence very quite noted, been your patients following this and directed you very been sclerosis. refractory and suggestive closely. The this for with CDXX is therapy. deep expertise as in space we've reported inflammation early question. in

And so more this well and we'll opportunity. inspiring organized And you the can imagine we we're around to found quite were have that that report in future.

one think question. we've Julianne, I for . more got time

Our James. last Gary question come from will Raymond Nachman from

Great.

So have that. back to I MariTide, finish with to

the as Phase in U.S. any how Phase studies for studies this do have start those how And space? quickly in program? planning big and you're anything other timing accelerate sense be? as you III ex III U.S. overall design to to studies, you have of both those possible a you'll about the you could and those relative As might strategies incorporate And and when

those I it. questions. appreciate understand be why we again, Gary, asking can So you'd

the the can. huge more We that. believe know best jump anything asset and in still the swiftly in efficacy whether you Phase as III that Phase have can regulators don't As as do remarks, our but we . we an say need if do you we specific, to do we program to can agree said recognize II feel that that I study establishes unmet then my in now and I we'll in there's a safety And successfully will swiftly help Jay, with level work address But marketplace. complete you and

moving ongoing the possible the as the within the possible as you is organization, study this design. rapidly regulators This that within say one can Bob. this program moving same, rightly is as rest expect. as you assured. as Gary, And I'd Yes, rapidly data know, around is conversations part collecting

Well, to to quarter and now of forward talk call. you be many having that and on referred team flow Okay. and let to and look around any reiterate again, me further you expect opportunity Justin in an for to that joining if thank his second on information all have questions. on the summer We you will the between the programs provide we've generate the we after update that then the the call to

thank you interest. So for it. your Appreciate

QX concludes earnings This call. our XXXX

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