Earnings call transcript Q2 2023

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Operator

My name is Julianne and I’ll be your conference facilitator today for Amgen’s Second Quarter 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speakers prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. [Operator Instructions]

to Sood, like Investor President now Relations. would introduce Vice Arvind of I Mr.

Sood.

begin. may You now

Arvind Sood

Julianne. you, call for our our everyone, to results quarter. second Thank the afternoon, discuss Good and welcome to

pipeline led oncology strong down continued growth quarter by outlook year. of the augmented the of This development. the meaningful to We growth unit also longer improved an term updates, sets path during an volume the rest particularly the with for that stage some for

Bradway, will remarks, Bob team. the call broader Our of prepared CEO, Chairman by leadership lead with some of followed review and our a by other our performance members

non-GAAP You should our performance. measures just have our we course to a have that And of results actual reminder a use received discussion, materially. we’ll our forward-looking can financial slides Through some vary the to describe posted. make that link and statements

Bob? with would to So I that, Bob. to turn over call the like

Bob Bradway

joining the geographic growth confident per billion an ability along revenue, our therapeutic growth the Okay. and remain areas quarterly and was share very deliver Thank about It ago, Amgen for non-GAAP contributing reflects three delivered We earnings. X% from of demonstrates sales we performance. up in three that long-term attractive for our regions one in to our board that to all X% was $X you with why call. across year in the our quarter $X excellent up record XX% prior and a share, a globally of Volume earnings over year. quarter, of and all

continue world-class serving have time. our every patient and manufacturing XX%. in in every time have us source industry, was growing growth identified meet in for our by product in as shortages enabled products longstanding capabilities a demand tradition region, our which us, general we grew volume previously XX% For Pacific to of the for volume quarter, while our the At Asia business a our of up key of example, medicine

prescribed my our many against physicians our categories said like contribution generated time, cardiovascular quarter and the reach biologics first to in in time billion with one first something marketed highlight fight call of to disease. time care which comments from record over substantially for I’ll is our consistent the patients is widely contribute long-term I to to currently the Prolia more growth. In it’s up Repatha a Prolia, our in of Nine replicated the making primary achieved to quarterly first products expect chronic treat potential Today in the of when sales by medicines disease. significantly for I sales growing and XX%. we see spoke quarter. in over other disease, $X April, be to This the April see cardiovascular about we

bisphosphonate of we’ve Prolia lot. With alendronate, remains women undertreated underdiagnosed world in fractures, in and all is real most reducing not disease we data, success fractures. generated placing elderly prescribed recently life-changing the and a For Prolia a an the treatment of little, risk for established though know at but to that frequently superior by that millions by osteoporosis U.S.

more only in the which in real we That’s in growth achieved Prolia us by announced you study, become that superior. give compared world hip May alendronate. point, one two one against as the give osteoporosis, Prolia that XX% to a reduced will a grows fracture older. EVENITY, powerful quarter sales To data world prevalent a the disease of punch XX% risk and

first half of You’ll performance hear very more commercial from Murdo shortly strong our the about XXXX. through

in cell you’ll from combination lung data with today tarlatamab positive hear for in pipeline BiTE, for momentum in Dave Reese, our too, small cancer. strong LUMAKRAS our sharing We’re as Vectibix we’re in detail in cancer colorectal seeing and

excited otherwise T-cell in Elsewhere pipeline, registration it is that also dermatitis, what in as bemarituzumab tumors poor, demonstrated we as the heart whose advance continue may We mean effective treat an several prognosis because for but the to year. readouts readout, engagers of with are look are well for to patients of conviction especially to our tarlatamab in the growing enabling BLINCYTO. bispecific additional of exceptionally medicines solid half forward in disease, We potential including way our we course cancer. rocatinlimab in because only liquid new it first-in-class as not from about tumors gastric our adds to have atopic trials Olpasiran second pipeline and

independent quickly manufacturing more patients an will and R&D especially products, have biologic to Therapeutics, Turning diseases. Horizon of suffering serious deal commercial Horizon great to capabilities, than reach achieve about a global accomplished for has companies company. together can medicines our own. Horizon’s acquisition what as achieved our patients enthusiastic rare certainly from Horizon planned on we enable its very even more Amgen’s remain for could

to notions. speculation law. are established their not FTC’s arguments know, you exception in by grounded Notwithstanding Federal United long that case, stated has pursue this case ignored combination in with the around approved States. the concerns. commitments this we to antitrust the the in Their based the and they’ve are As in arguments The address regulators world, of Commission this made choosing Trade hypothetical been on

and just competitive treat Horizon, I ground on by drugs we anticipate forward is integration our look the Simply Amgen which when our September rather populations. meantime, the and me we’re mid-December, running theirs. with and before diseases being no close in can so court I’m over to deal. reiterate that case to different And able and we let will patient the hit medicines prevail. to we overlaps Horizon closely bundle more to making different are We point with Murdo. Life-changing plans confident In one working there incentives in put, offer that no hand

for organic As even growth the is growth our strong, is second further. quarter to performing prospects serve outlook will and illustrates, adding very Amgen’s Horizon enhance our business well

my by me the around unwavering thanking to for close Amgen to colleagues commitment and their patients world let our business. And

patients many we more about to excited Murdo? and We’re today. many, than future the serve do ability our

Murdo Gordon

Thanks, Bob. I in bring brands patients strong to to by performance and general products is the robust our mission a hematology-oncology with quarter, millions record and fueled with globally. our innovative Execution our business very am sales of volume nine across deliver the on to across medicine, inflammation commitment growth pleased for portfolios. quarterly second

year-over-year. exchange, of Including year-over-year. impact the product grew exchange foreign impact Excluding sales the sales increased X% product global foreign of quarter second X%

And the was East our expansion with growth XX% volume our growing was fastest region Volume X%. X%. with volume across Europe, And Canada to consistent region international in growth Asia-Pacific our continues was regions. growth America, U.S. Middle quarter. strategy, our growth volume XX% in and strength be with Latin

Cardiovascular the LDL state of Starting by of second public elevated our Aimovig. that XX recommended poor. ASCVD growth. world includes XX% which analysis Prolia, million volume in their quarter, general real these care ever with than fewer health cholesterol high is heart, and for four risk of with year-over-year a EVENITY, XX% revenue patients Overall LDL reached business, Family XX% growing levels. risk them high is Americans revealed driven Repatha, crisis products the medicines disease for grew

is will early and with risk a possible cholesterol as clear as action as lowering much Repatha cardiovascular for This that call reduce LDL to patients.

primary for and by I’m best-in-class by to to helping coverage is affordability. improving this Today and of committed increasing important adoption access Amgen ease access And of we cardiologists have Repatha gain so Improved adoption patients formulary need, U.S. XX% patient’s Repatha is care enabling access this meet broad to medicine. eligible providers. of

to So, record this for the a set year-over-year Repatha second $XXX growth XX% million in has quarter. stage which the increased for sales,

volume volume Outside U.S. that regions. growth In the meet from new We to with around growth saw adherence engagement intensify can XX% there directly still the Repatha. was world investment guidelines. bring more of record to urgency driven of by healthcare direct-to-consumer are drive through increasing to patients who testing momentum media with our U.S. across benefit and treatment message LDLC number starting patients challenge, we and recognize And we our are XX% providers, patients around to treatment. many the a our

Transitioning to XX% driven record grew bone quarter a health, by year-over-year growth. Prolia XX% in second sales $X billion to volume

presented discuss significantly endpoints Osteoporosis when reduces in new compared Prolia demonstrates data multiple across in alendronate. to World risk Dave the the fracture Congress more May detail on As real-world evidence will at

actively Our their for sales teams physicians understand these to are superior are the fracture helping reduce ability now Prolia of and data equipped of with risk osteoporosis the patients.

$X patients. driven are XX% performance share billion. at EVENITY, had our had initiation versus across for of which bone steadily for $XXX over Japan, strong sales market, competitors builder Prolia quarter by the the growth volume markets. of naïve now annualizing sales growing EVENITY a compliments bone increasing increasing achieved EVENITY portfolio, In million and record in

our impact Given the significant the the decade. are through lives success on growth Japan, women the this enhances severe in EVENITY first market who launch for fractures in potential our of of confidence post-menopausal

sales patients systemic can oral treatment that X% Otezla from by only a milder help and the more than therapy volume year-over-year cannot with systemic the be optimally approved million remains well-positioned with by topical X.X naïve like increased broad is growth. drug driven to a benefit indication Otezla a and systemic X% addressed U.S. psoriasis Otezla.

see affected drive remainder impacted XXXX. expect topical Otezla launched demand of by to and awareness and for compelling programs opportunity free will we drug new Despite systemic we of by physicians U.S. been competitors. patient programs in a the invest business Otezla be newly increased And to Our amongst has growth patients. this, and for continue to these

established limited are and and prior in the of testing coverage We given payer lack of Otezla safety ease authorization unique and course, of potential initiation, growth for required broad combination profile, of requirements administration. of with its a confident efficacy

large increased deductions impact levels. changes higher the offset during partially inventory Enbrel Enbrel to U.S. estimated driven by inventory lower the Year-over-year, and quarter net following X% selling in XX% drawdown sales sales quarter-over-quarter price price on sales and seasonal of the by first grew favorable

number Although improved of the flat in was year-over-year new by second the driven X%, coverage. starting in treatment quarter, U.S. the by payer patients increased volume

XXXX patients. coverage lead this the in For we of growth improved expect continued will remainder new to

selling We full also expect on a price year basis. declining net

the to to with option the the single-use $XXX U.S. increased treatment and Test improves severe, options convenient accessibility robust pen quarter. patients sales benefited approved all pre-filled, Sales second administer Drug self-administered, driven asthma. The by and offers more from buyer sequentially million in XX% growth in TEZSPIRE or with introduction first Food Administration in in XX% continues a growth show U.S. flexibility patients by that provides which volume and for uncontrolled home, at pen the quarter. the

$XX XXXX TAVNEOS treatment. XX% now been have In with providers. TAVNEOS healthcare quarter-over-quarter the in million over patients treated driven the U.S. patients approximately second an new by increase XXXX of quarter. were in volumes Sales starting grew U.S. by

partially presence market ANCA substantial Looking deep forward, and experience more even levels inflammation growth. support growth XX% by driven to after the decreased the for allow bring inventory patients offset partially Amgen’s price. AMJEVITA us stocking by associated selling launch with in volume year-over-year in sales sales to volume and net U.S. will inventory vasculitis. second XX% lower offset quarter, to sequentially nephrology by and TAVNEOS drawdowns first by driven XX% a increased quarter,

which with execution LUMAKRAS, commercial Strong to new adoption oncology Moving grew and business, drove academic sales BLINCYTO. data Vectibix, centers. hematology KYPROLIS, pediatric includes BLINCYTO innovative community XX% our XGEVA, for products. volume year-over-year these clinical and growth and six year-over-year exciting across XX% Nplate and

May. from EXXXX in XXXX, of were December an study NCCN guidelines that data updated positive registration the presented enabling issued in Following

demonstrating our with data of quarter, the from confidence for for growth Vectibix XX% positive support volume the and year-over-year driven of combination guidelines in growth positive RAS, second for the with data XX% potential the sales the supported by cancer. X promotion the Phase by Both increased colorectal in Vectibix updated trial patients superiority BLINCYTO. bevacizumab over PARADIGM wild-type continued chemotherapy

development LUMAKRAS future We lower KYPROLIS new XX% launches program. our XX% in were volume LUMAKRAS million quarters. clinical net the partially opportunity sales was driven flat of by comprehensive for and growth, price. driven for And grew in growth see second volume offset inventory levels. and quarter. selling growth reported $XX by the by X% offset sales markets by price year-over-year net Year-over-year lower selling global

Our and exemplifying is across driving to execution our serving the patients. dedication strong business growth

and benefit who more with in our acquisition Our inflammation have business is of many can leadership and level announced performing Horizon Therapeutics, potential serve very at high the the decades from patients to of nephrology. we the

I’ll that, with Reese. to Dave it turn And over

Dave Reese

Murdo. Thanks, afternoon everyone. Good

high on oncology, results of Beginning two progressed line quality the with R&D, more small the in after this with progressed exceptionally top patients was important or treatment. with global BiTE that one For second readouts, year. we quarter our relapsed evaluating prior lung cell two from pipeline we are exciting announce as targeting track to a registration additional data first-in-class data trial multiple Phase of enabling tarlatamab, cancer execution and later refractory pleased positive coming X molecule innovative DeLLphi-XXX lines DLLX or studies

and rate Phase X Tarlatamab time tumor, primary in chemotherapy. to in reported demonstrated Responses favorable previously compared common endpoint first shown was what cell the care longer X with an the field. Safety study. activity the objective that is tolerability study. more a device-specific the what unequivocal were were expected has durable also T milestone solid in at response and of the This engager a exceeds substantially than standard Phase real the is

observed, upcoming this an potentially with Medical FDA Based soon Phase and look agencies to on presenting study moving care of lung detailed earlier study tarlatamab the with tarlatamab and have into Congress. X cancer. comparing regulatory DeLLphi-XXX, of a other these are cell and X second-line data We standard of at results lines registrational discussing we Phase with the forward data underway we small therapy chemotherapy

planning oncologist, and I the initiate these cell small of lung additional Phase with cancer. this point, to molecule transformative are earlier an of tarlatamab to personal in share my believe We X vantage can lines as data two field. studies From be can’t wait also

on cancer, other we biology can cell Turning necessary the to continue LUMAKRAS the tumors. and our solid execute in to and role to understand clinical program LUMAKRAS, play designed cancer, breadth to data lung of non-small colorectal comprehensive generate KRAS

global this and CodeBreaK doses. met primary XXX signals. in progression-free for both X with the comparable Vectibix in refractory its mutated new efficacy previously no evaluating GXXC At doses, that announce KRAS with what XXX Phase of milligram consistent trial metastatic to was combined with delighted are LUMAKRAS observed colorectal We milligram results chemo cancer the setting survival were XXX endpoint safety

colorectal FDA an these therapy authorities by from of for Medical LUMAKRAS who breakthrough CodeBreaK to patients mutated in GXXC XXX an with forward designation Vectibix to presenting cancer Congress. the prior treatment as on based received global chemotherapy recently KRAS have data test detailed at the look upcoming sharing results The study. the health We with metastatic FDA and results with prior combination approved determined granted

cell support in SCARLET with Recently provide data, a non-small to explore combined initiation these patients cancer. with LUMAKRAS mutated in with lung negative Phase in first-line PD-LX novel first-line GXXC combinations with from data Beyond Phase LUMAKRAS colorectal of as FOLFIRI of rationale study trial tumors continue Vectibix X and seek the the cancer a presented the Xb we we setting. combination initiate data Vectibix chemotherapy and move LUMAKRAS the chemotherapy Phase and to into first-line study to of X

X.X%. second acute for approval accelerated June, The approval and a with or complete remission FDA the the to to disease adults supplemental greater first In minimal B-cell approval. for BLINCYTO’s equal than license of the BLINCYTO treatment biologics with pediatric approved application patients or full precursor leukemia CDXX-positive residual in lymphoblastic converts

with track submissions Oncology Network, the Institute, conducted Group Radiology for trial Research National Cancer and are overall Group Imaging chemotherapy with added over newly ALL of induction care BLINCYTO intensification patients superior negative treatment MRD consolidation survival were consolidation diagnosed standard following who adult chemotherapy. chemotherapy Philadelphia and Eastern EXXXX, a Phase demonstrated on Cooperative Global that by Cancer X College to American regulatory negative in the of

lastly, line Cancer oncology the disease. updates the of tyrosine Network ALL. top in clinical Three for combination kinase as positive the the included listing practice the moving adult preferred made important Philadelphia regimen EXXXX These or MRD National B-cell algorithm disease. the only chemotherapy as were Philadelphia regimen BLINCYTO with in in treatment MRD to BLINCYTO negative to of Comprehensive first BLINCYTO in consolidation adding patients inhibitor negative treatment And a to negative multi-agent guidelines

BLINCYTO to the in improved historical KMTXA-rearranged XX% Medicine compared Finally, to in April, alone. as was chemotherapy data, XX% survival two-year demonstrating that chemotherapy Journal data or survival BLINCYTO published of B-ALL England infants added were in versus two-year New in

ALL disease, disease, administration. through is late-stage about treatment of earlier look remain on is of it in paradigm you patients the subcutaneous future clear We in in data, early the at older its in focused are excited of totality changing and treatment that and B-cell If improving investigating lines patients. for young the and further patient in BLINCYTO the potential BLINCYTO convenience

Xaluritamig where XXX. BiTE and Two first is oncology additional a BLINCYTO the expressed the as are cells. tumor tumor lower a watch Xaluritamig [ph], bispecific cancer on studied As also burden. roadmap first-in-class provides for prostate in to steep programs one advanced tarlatamab, being have almost one development such which of molecules could in of steep activity AMG early is all settings targeting enhanced

in are setting. and cooperative this is a MTA advanced of MTA of another patients requires significant of AMG MTAP-null expansion first-in-class activity are rapidly AMG biology in the engager of T-cell leverage PRMTX and to PRMTX provides observing tumor molecule MTAP cohorts. overexpression in in solid the tumors. with being anti-tumor XXX the We activity to of we design small Xaluritamig studied MTA which demonstrating bispecific dose leads with absence a accumulation enrolling example the The XXX, a inhibitor solid of molecule presence inhibit effectively this PRMTX. unique

solid drug. prognosis associated have often this with poor in approximately occur hard are and XX% tumors a Alterations to pathway been historically of very

multiple are both to a encouraged is it XXX, are AMG sharing tumor fall. we’ve study We this forward currently types. Xaluritamig We responses we enrolling anti-tumor the in Xb/X from data of early, Phase by look while XXX AMG and and observed

potentially maridebart outcomes X our we franchise a emerging known molecules disease trial as as small focus medicine, obesity related enrolling patients a are in obesity well of is execution. general with Lp(a) targeting is advancing clinical with study are with cafraglutide or of AMG of and Phase portfolio X and study best-in-class In interfering formerly molecule XXX cardiovascular Olpasiran diabetes without The atherosclerotic Phase RNA comorbidities. cardiovascular and on

study the leveraging strong generate of X to broad sustainable maridebart unique weight will optionality we Phase of is substantially will to cafraglutide properties risk of mentioned, provide million real program X United goal In deliver The the osteoporosis alendronate. women oral program data versus design fracture as study with patients a presented a a that Phase post-menopausal May, that Medicare showing in of Prolia in from the reduced nearly half States world data loss.

showed that was same real addition, These importance Prolia large world Prolia fracture are reduction of study ability In osteoporosis duration greater patient using the major great populations of osteoporotic risk. in data with and the a to longer associated treatment post-menopausal of in a effects the study evidence. in treatment treating demonstration

In in Phase severe with chronic eosinophilic with polyps studies separate additional nasal are investigating we inflammation esophagitis. asthma, indications and X beyond multiple including TEZSPIRE rhinosinusitis

top studies, broad two chronic and eosinophil enrolled fully with have X The one also high We both line anticipated patients with is The complete COPD. imminently. urticaria spontaneous counts. recruited is CSU has population including and Phase patients, trial data COPD COPD other of the in in low study and in a

We the in study this clinical severe the a Rocatinlimab dermatitis. program. on XXXX. first first-in-class off in moderate antibody to ROCKET patients of is Phase atopic of half X start look being development readout with forward strong Recruitment to the to investigated monoclonal anti-OXXX

to of indication. to the clinical planned on biosimilars. with execute Phase ABP Rounding explore a pivotal with evaluating the compared new additional X one initiation planning we’ve study this those initiate OPDIVO similarity rocatinlimab recent asthma also our of time in six summary, portfolio, a pharmacokinetic including and of out we moderate biosimilars XXX on budget the study in to severe continued are uncontrolled as We

platform, for to with represents of in illness. proprietary patients recognized work In collaboration that on and T-cells a focus meet identify Therapeutics. This novel treat I’d to needs highlight disease investigating discovery world with closing, to we TScan use to antigens execution by the to Amgen approach hard the I’d like collaboration this thank around a to recently TargetScan as announced Crohn’s target patients the is tough like relentless will TScan’s multi-year the we serve. staff our their

Peter. to over it turn now I’ll

Peter Griffith

you, Thank Dave.

commitments. and increasing beat investment year delivering and year our XXXX X% in confidence position with our non-GAAP research performance. This Growing EPS to development us pleased quarter our meet against strong second longer drives in our or objectives and by We’re volumes term keeps growth. XX% in over delivering

I’ll results second review our XXXX guidance. discussing our quarter before

a As Horizon reflect announced standalone a without for the results adjustments reminder, these and any outlook basis on acquisition. Amgen

highest financial X% second year-over-year total Slide quarterly total sales which on Amgen’s in foreign the exchange our increased while of Product increased X% revenues XX, to year-over-year, and X% negative impact Turning quarter $X.X revenues shown the grew excluding results, rates. billion of are history. revenues represent

non-GAAP expenses and operating of discipline. pipeline in and Second accelerated products, while margin sales our quarter our a of delivering product a XX.X%, across operating X% increased We marketed priority total year-over-year. invested growth as advanced demonstrating percent expense non-GAAP

increased stage XX.X%, R&D spend year-over-year increased shares reflecting by of mix. product sales marketed percent X% a in higher quarter profit pipeline, sales the year-over-year, driven and a driven programs our basis late on to in higher of product investments product Non-GAAP X.X a spending percentage by cost changes growing primarily in as points and on Non-GAAP support.

quarter expenses in the year-over-year. SG&A decreased X% Non-GAAP second

execute and What started in uses We continue to prioritizing focus already cases operating productivity any continuous and historically improvement of on digitalization investments, we of artificial in number other driving our have beginning continuing. and to model, intelligence.

the were a included quarter. year-over-year Beijing Non-GAAP results. from only was change favorability the impact income accounting driven GAAP $XXX the expenses expense in in mark-to-market net a other in investment by second million with methods our This primarily and to equity

change As increased percentage expected, the law X.X replaced Puerto primarily an tax excise to beginning with tax due the income XXXX tax non-GAAP XX.X%, that tax in our second quarter to rate XXXX. Rico points

priorities. to continue our execute allocation on We capital

North manufacturing our driven of products, we facilities the as investing in Carolina. olpasiran and investments Second, AMG marketed stage by an we our peak innovation. well for late as spend in and levels In Ohio external simultaneous continue higher both XXX priority Capital at such expenditures internal including our drove QX, state-of-the-art near continue in best support our we innovation, [indiscernible] as in business. construction First, programs, are

return begin to starting annual to capital begin the We licensing and to coming expect to capital levels and of our XXXX plant with the completion years. closer Ohio over then historical will decline in our expenditures expenditures

third, We of of share increase XX% shareholders. continue return to quarter, in we second $X.XX the pay over The And plan our quarter XXXX. company generated capital a second per $X.X to dividends the to representing billion of free the the interest quarter payments cash of $X.X by quarter the higher of primarily second and in second billion timing includes income flow operating versus in XXXX, tax driven and higher XXXX of income.

cash the We margin roughly remainder year for flow with and our outlook expect non-GAAP strong a the financial of XXXX XX%. year, full of consistent includes operating

Now turning to the for on XX. outlook business for XXXX the Slide

is projections. and Horizon currently include standalone guidance does not on the Amgen any Our business provided

As is that after close mid-December, included the from to period. Horizon Horizon by would transaction resulting contributions expected be

billion performance, to raising Given are we previous XXXX of revenue versus to to $XX.X guidance our $XX.X $XX.X our strong billion guidance $XX.X billion billion.

impact the to the quarter results our lower the expect third second guidance, donut sales in to to is confidence pronounced in second year of the changes to give quarter, and raise more the second of to maybe sales estimated half deductions us also compared Medicare year, the we full which our quarter. favorable Although certain the due hole,

versus our EPS given position earnings revising from we in are $XX.XX. to our share priority increase internal $XX.XX investment non-GAAP acceleration products a in and intend our the our to $XX.XX to our business along guidance previous revenue improved reflecting guidance pipeline, plans guidance, per non-GAAP to innovation with $XX.XX of we our of strength, outlook our Regarding and investments marketed

expect in expected consider model to Again, and the sales full and to non-GAAP sales $XXX full our quarter, you of approximately Neulasta the our of from $XXX combined third and us project year to results approximately we resulting give XXXX, the the although remainder to MVASI second raise quarter business. EPS, QX Important now lower million. year additional EPS investments as compared our non-GAAP confidence full year we KANJINT points of sales be million

million versus $X.X of $X.X to Note $XX to agreement other results of repeat of we billion XXXX. in billion billion expect not now milestone included for be XXXX about that earned the the expect quarter to to range related the our COVID of in range to our that manufacturing and revenue prior We do our $X.X XXXX quarter antibody third third revenue we $X.X billion. other

We anticipate expense including of to cost increase Otezla. full by last support sales, compared additional with driving for for operating higher marketed and our X% versus projected closer estimate of previous XXXX increase growing sales increase a year Repatha to and products, year our X% pipeline from non-GAAP investments to increase our innovative priority

continue to roughly full of in percentage as a to quarters. a will remaining margin year XXXX operating although We expect the sales be two of product XX%, vary each

expect and percentage continue cost to XX% We non-GAAP product to will between sales as the XX%. be sales of

our of X% to We now prior about our in expect than higher expenses non-GAAP R&D XXXX increase X%. to X% is year-over-year, which guidance

prior SG&A a sales. down now spend billion expect $X.X range billion. as $X.X slightly down billion percentage guidance billion in of be to non-GAAP income and other expenses product to to non-GAAP the to continue year-over-year We $X.X expect be the of of $X.X We to from

tax of XX.X% rate down year, XX.X% non-GAAP a XX.X%. prior from to guidance of we the For XX.X% anticipate to full

the tax of expect the rate We QX to revised upper of near range to XX.X%. end be XX.X%

expenditure capital remains guidance Our at unchanged million $XXX in approximately XXXX.

Our patients second mission the of our to incredibly acquisition quarter serving beyond. for the XX,XXX in growth we strong mid-December the by grateful colleagues I’m executing our and indicated. Amgen, for forward on Bob announced long-term and successfully completing plus Horizon of to confidence in look long-term and outlook is as

concludes I’ll This over financial to turn update. the Bob it for Q&A.

Bob Bradway

that, the questions. they I Okay. of for callers can remind you Thank ask you, procedures our Peter. And And just open now the to so please. operator line ask for we’ll doing

Operator

Mohit ahead. [Operator Wells Instructions] from Please Our Bansal from question first Fargo. comes go

line is open. Your

Mohit Bansal

there on for are suggests reading in my Great. one is congrats and – are talking and of concern quarter. There an some safety models, question the that on gamma. people OXXX. lacking about the and and some very taking of interferon autoimmune Like OXXX. Thank OXXX I’m you the literature OXXX concerns phenomena, impairment question regarding animal much one Maybe is

to understand are concern is Thank in risk we how you. just that Is And mean all So drug? there? – particular at you it managing trying it a what this how phenomena?

Dave Reese

Dave. Yes. is Thanks. This

X we’re the such is tracking, T OXXX program, in something setting conversations. atopic of Phase this One we T phenomena. those have approach parts. What autoimmune concerns cells clinical question signal tell me your Obviously, observe we not dermatitis. is or but aware at So did in on is of of no cells expressed that activated In I and activated indication the you time. can pathogenic mechanistically, two primarily let are this we

That’s your imply question for treated at cytokine we something interferon placebo greater for signal. followed we will example, than they’re not gamma are routinely inhibition had infections. that programs. all not Phase rate have a date, program. see almost that in for These But regarding follow, we did X the also in would risk, things to Likewise, patients

Operator

you, Thank Mohit.

Our Jefferies. next comes ahead. question Please from Michael go Yee from

Your line is open.

Michael Yee

sales. in is Hey the for your question. aware this and market business? a in at market, with least in least why dialogue ongoing you’re And company going ongoing what in for discussions uncertainty you ongoing about I you lot guys, or the regrowing the you. Horizon TED this around about on there’s think at Thank confidence the know thanks market TED? the or enthusiasm you your going have TED maybe excited of an been about confidence of Can for dynamics on with the deal. Bob the with commented describe general the just

Bob Bradway

talking appropriate And of very to the can course, view the just expand parts. data clinical and with Horizon Mike. But marketplace the based very in there. developments Maybe opportunities of we of we’re view ability the about answer Sure, at excited again reiterate carefully excited you on think it over in and a in can to We our of that. further. our do I’ll let Murdo, we two reach moment. we Murdo But our international that as friends remain elaborate product, what watching Yes. me don’t and why and kick the about we’re

Murdo Gordon

for CAS the public with their catalysts the in and what data growth domain, in vantage start have execution the but in our presented not here. point, from to published, They’ve patient Horizon we They yet the that footprint, now commercial there’s the expanded public that and population already should sales having and forces. U.S. From their is Yes. several Mike, strong in results so positive by domain take with trial team for hand traction. low see been

So that’s very their performance. recent in and reflected not necessarily historical

international launches. market Bob the mentioned

believe being to able continue accelerate be help post-close, done We work the we there. to will

remove prior lower calendar should medical that’s some also and the say, the so for very improve CAS TEPEZZA see issued or I seeing patient encouraging payers policies of We’re improved to being use the restrictions, on year to new population.

population for are a and So there large data. very across from clinical is good catalysts, disease the remain many we benefit unlocking utility quite what see I opportunities given horizon who additional growth, of would eye on those thyroid that systematically and bullish TEPEZZA’s treatment patients

in cast their The results mention population I is on in should replicate OPTIC-J, able to last the OPTIC-J trial. thing, were TEPEZZA also low they

but the registrational they’re low cast, disease OPTIC-J. Sorry, eye in thyroid data not for the

sets them Japan. that up well potential for future launch in So

beyond execution look data and focus really And and here. So investment good TEPEZZA. really good flow,

We also large very, remain excited very UPLIZNA. brands other two obviously inline their and about KRYSTEXXA with

working a two confident portfolio So remain companies together good and be on overall, parent. really that the will excited strong this we

Operator

Thank you, Michael.

Our from from next question Please Richter ahead. Sachs. comes Goldman Salveen go

is line open. Your

Salveen Richter

compare a Phase In us, XX Thank for for I you. objective in response think X Phase on you details response a to Phase top-line does you this of particular, confirmed of of the it cancer Thanks had the put cell where you data small results. more noted Good median Could profile. taking share months? XX% tarlatamab substantially exceeds in the question. X and X my lung rate into duration context any how the data afternoon. for

Dave Reese

Yes, Salveen, thanks for about the very question. this excited small molecule. Very,

a If Phase you as substantial reported had context Phase noted, what X, represents it we BiTE in put the hoped response platform I major to To see in the in substantially think, the we that clinical in in effects a rate step data tumor. and comparison exceeded solid back, XX% to X. we the

and more at response, that be pleased terms present data more I course, of can embargoed the planning providing of you response terms data, with – are it Fall We the Conference to couldn’t in these tell overall specifics. duration a rate of But on survival. in

XX%, typically they a months. For with well or in response are under few cancer of in patients brief the third-line context a often small weeks instances, importantly, in vanishingly cell but rates most are lung matter

BiTE of And we so, be based where on have tumor in with of enhanced towards a we history chance observed the therapy setting what have really we’re this BLINCYTO. as disease particularly of march observing, I the lower think the activity a should we burden earlier to change disease, lines as natural

our earlier line focused trials. efforts So now are all on of executing

to and So, this to results these fall. I pay is forward think attention presenting this we’re to go we one really as looking forward

Salveen Richter

safety? Dave, to about you want anything Obviously … say

Dave Reese

in And of development think have terms about the clinical the management safety, learned lot in sorry. a the I we here. I’m program

we’re present safety the the look We’re principal when those happy syndrome the well of sharing rates forward release effects, like fall. – quite as and with pleased But with and tolerability profile we’ll details we to exceptionally side cytokine well. this as data

Operator

Thank you, Salveen.

Our with Olson Please next comes from Jay ahead. Oppenheimer. go question

is open. line Your

Jay Olson

Oh, hey, LUMAKRAS And especially the birthday and quarter the congrats results. Arvind. and on happy to tarlatamab

Arvind Sood

Thanks.

Jay Olson

LUMAKRAS? For little about cancer. and the Can filing maybe colorectal the CRC you bit in about market in and timeline, Phase you. talk opportunity a X, the for Thank strategy LUMAKRAS just

Bob Bradway

colorectal mutation. Yes. smaller In X% a regards, obviously GXXC is patient population, this about of harbor the cancers

those other trial authorities the guidance have terms FDA And chemotherapy disease. Xb data X advancing the a plans provide these and In data. to conversations Vectibix regulatory And with unfold, in then, X Phase discussions data our combination the here regulatory the about also setting based on next first-line these we are a I’ll steps and as strength first-line using of on Phase as in Phase potential mentioned, pathway. are LUMAKRAS of on I

So, in the give as next its I again, guidance I’ll had think colorectal cancer well. about appropriate steam full And steps conversations. we’ve ahead as

Operator

Jay. you, Thank

from comes Raymond question Sandler. Piper go from next ahead. Please Our Chris

is open. Your line

Chris Raymond

Piper from warm Arvind well. us to here as birthday And at Thanks. wishes

AMJEVITA. on Just a am question

between maybe So, But talk the obviously the couple the if opportunity. you about uptake most uptake, AbbVie that in what guys the maybe around U.S. priced sort of first been Can surprised split of maybe has maybe maybe anything you terms maybe not questions. on a been second, has low What, part blunt forward? high the lot maybe then you what first there’s the talk and has date. done was done plan originally And in what’s a biosimilars they’ve their and scripts guys, when going to to in SKU. sort of talking what about were of contemplated,

Arvind Sood

to that, want Murdo? you Do Yes. Sure. take

Murdo Gordon

for Chris. you the Thank question, Sure.

having We’re this with early light still behavior new product obviously clearly AMJEVITA, what innings in very seeing a payer in we’re biosimilar large market biosimilar competition. and is such of

But utilization high high payer the cost again, XXXX. cycle think versus don’t it’s We PBM next I – mix. yet to kind very we’re net respect SKUs. two waiting low, the – a of the attractive happens between where also are early IDN cost going we the product what negotiation has utilization see to the I to in low is it’s them. still those into in With say in out different see settled the mix, would low in mostly that the the and low

biosimilars PBMs haven’t in saying that whole the record many more as terms a seen driving in they but As in of to of done XXXX, do of that on are of XXXX. lot utilization you’ve plan

a strategy, and well. their against the compete against think them site in we And biosimilar, to lot more follow them with we with know our I So there’s look, compete here. and AbbVie now practices respect to we innovative

lot uptake, and a is that there, with to onlookers. clarity us and think of I not biosimilar – I of surprises clear becoming works to the biosimilar other the how So thereof think pharmacy lack but or benefit other manufacturers

excited biosimilars longer would growth there. to the the follow say about I of in very more term. So though, we remain

as the development continue Dave We to with research most additional of OPDIVO. investment a in mentioned, commit of ABP XXX, the initiation with to continue biosimilars – we biosimilar recently

at able were other launch reimbursement medical MVASI successful, U.S. our are also system to in launches. the where that’s We KANJINTI in continuing being previous to and benefit with biosimilars look and obviously the we in

generate growth benefit from we’ll be strong and Having biosimilars. XXXX able double previously So to come the sales our billion. going $X roughly of ex-U.S. to believe will of forward, we our biosimilar we annual And said than medical growth. majority more would that U.S. continue

Operator

Chris. you, Thank

next comes Our Evercore Please ISI. from go Umer from Raffat question ahead.

open. is line Your

Umer Raffat

a guys. it felt month the as congrats today, were birthday fair meaningful study? also response back half Thanks I data, percent horizon Dave, improved on you secondly question. like plus all PFS the is by My and was the the is PFS And so was you deal, a And it XX were DLX the prior for data. on And way Hi think question a I roll rate. my taking in say the it I Arvind’s feel on are clear. two describing things way in judging to transformative, like on in three

committed you far. the price? up there is coming very You’re the is, that renegotiate at the least from falling to very investors deal, question so And TEPEZZA to much. that’s Thank any purchase is dramatically but way also short

Dave Reese

Yes. data rate, an embargo overall have I’m of we’ll with What very the of survival, under and efficacy – I overall is can package being is response the the Congress. into response, duration upcoming efficacy – say number medical this progression-free that me all to overall Umer, of without – survival. happy specifics a on presentation package. very compelling at very, it’s And But those getting

Murdo Gordon

horizon, at would on but day. in that announced. another you’re And the right, proceeding is our basis for on the perspective what of deal Okay. we question, from your remain we issue least Umer, was with leave about that implicit enthusiastic take we’ll different I

Operator

Umer. you, Thank

from Yaron comes Please go Our next Cowen. Werber ahead. TD question from

Your line is open.

Yaron Werber

a though which OTEZLA Humira. is doing got It’s of sort generic Enbrel the in gives net from contracting of of that’s label on have I bouncing is is back, question for drug program. Great. put a question. and ahead? Thank a and the in OTEZLA too, good confidence and AMJEVITA of as benefiting Thanks to SOTYKTU, to really uptake. outlook terms taking What you’ve looks like sort specifically, actually given you. place lot Enbrel facing well benign a obviously see. a relating the in that It you which pretty

Bob Bradway

strong where right. major and Enbrel – quite across you’re from Enbrel, had did we’ve question. benefiting best covered has we’re the the have access all is for Yes, the PBMs Thanks ever Yaron frankly, quarter a now. on

onto some of with Enbrel. price in patients And year. coming perhaps we will biosimilar sustained through we what last is not think clear the was overall, volume more biosimilar patient of the We we’re bit new Enbrel, that that impacting was seeing category on impacting seeing. now growth give course also flowing I So through competition up nice so that, But treatment Humira Enbrel, really so a for and concerns do did I new that definitely that Enbrel. that’s support the this it’s that quarter Enbrel. negatively quarter somehow pretty second And were there quarter in was last wasn’t think activity clear to

see So we in going – Enbrel we’re stability forward.

we’re in OTEZLA, OTEZLA. actually strength seeing For some

pretty ideal of treatment. really patients as is investing of more agent. what these with X.X And for in million mentioned systemic new the also would mentioned do the pleased U.S. a think with in That We we’re that momentum persist the prepared initiated like. we systemic patient backend And topical OTEZLA a can helping are there’s year. OTEZLA better I And those epi first be we’re significant we topical looks remarks, are on gaining optimistic as We that. better – acquisition the systemic and post the is being reason Peter is my patients. this in through in agent. And here

commercial with great prior have We coverage little very OTEZLA with authorization requirement.

testing And very good. no affordability for is requirement initiation. have and the We out-of-pocket

systemic again, easy else PBMs disease of coming that they has topicals off agent the from perspective. formularies. So And dermatologists being form indicated option a systemic an and a to milder the population for is pairs it’s OTEZLA that treated. and is for no an maintain this first attractive and And on would one patient mild choose as for for their option

thesis overall, So is good. the

there the pressure What SOTYKTU. would’ve into their resolution that and switched put and that, seeing who on slowed. they is coming to oral we’re clearly have probably our has SOTYKTU symptoms patients market full think, us I on Now, where psoriasis were were didn’t of

trial, patients on abated, were of losing year are in has have programs had that current that other we first mix out they on – less that topical the put pressure We free us the goods the flattened they that and think and treatments of was in the we getting other our to also out. part the dynamic And SOTYKTU there, Otezla.

topicals So we’re from pressure from less getting patient and much movement away Otezla less SOTYKTU. to

perception of into we XX to access penetrate the patients. So evolve our confident for can of the but that how access see current of really I have Otezla, further agents, will with safety current think we’re very the and population and novel we the efficacy

So going feeling forward, we’re about good it.

Operator

Thank you, Yaron.

ahead, Our from next your go Please Capital Renza Gregory question RBC Markets. comes is line from open.

Gregory Renza

you taking implication medicines Thanks. the Congrats ability quarter of on I the a on to Thanks the eyes the And Horizon deal negative my certainly maybe up you Great. the for out, and build just on for ecosystem biopharma, creation, guys. outcome that Amgen and like before regulators for the value to case to question. thanks your to the the essentially on we Bob, companies that, appreciate the just courts. and framing on to conviction potentially bring thoughts patients. laid wanted to, ask

opportunity to you just to preserve how it willing prevail much. we theory if that this far to the and would so bundling the like novel Amgen close maybe be would Thanks So this call legal that does have? And to really what deal? that, impact take team that

Bob Bradway

full live expect globally. makes established I of in which hypotheticals capitalize in based recognition is potential a particular their assert having their that in think forward I we it’s law. the there case right, to And and in on them in fragmented court. that And of your is We on – in implicit look speculative it for innovation, And is my any that don’t to what what would remarks, lot think prevail think prepared antitrust to the industry, that and especially court. on size we I what’s I they, notions. a again, innovators that said Well, believe again, very are based are we to difficult question reiterate chance we a that that a

is play like to like bringing role there so companies for companies Horizon. And value in ours to a

our repeatedly, I the but capabilities think manufacturing, than like reach patients we development research it company able about demonstrated expertise far us organization in own. for talked commercial have the have we we be global will to We’ve enable and its more on with think to this, products that would

exists ecosystem has on continue an the to States. from that for companies fewer be will the again, capitalize So that this that companies, to is think innovation, in that strengths, the and other’s by the result biotechnology most combine to were for And fewer flourished United would that patients. for each not being part able innovation reaching it expect possible we benefit industry

So outcome. that unfortunate an would be

Operator

Thank you, Gregory.

from BMO. Seigerman ahead. Please next Our from question comes go Evan

Your line is open.

Evan Seigerman

for Thank Maybe expand you, had significantly asking to modify due question. to a guys. just prostate program for can Dave; one update safety PSMA much this so issues? whereas versus the Thank taking biologic in an rationale context on competitor Hi to different their of much. from one we yours, you steep had PSMA than very you cancer? you today, they my target I’m you and And

David Reese

Evan. Thanks Yes.

bispecific that properties universally generate with cancer been that advanced expression, – window cells. engagers. e you we’re so one. reasons the a T-cell looking be target so to always allows not one a to with challenging therapeutic on has couple expressed tissue level to is There appear There high We’re for target. PSMA almost extensive unique it’s that Number target. steep normal

As development. clinical I have gone including then and out some into multiple of think our you’re of fallen aware, molecules own

maybe come related. And the I’ve to belief target part in that that

another be but to screen [indiscernible] under think else. we data; And on and one the a to is steep a now, this novel seeing radar the a based I either really relatively is this program you opportunity. of in anyone is So compared to far we’ll advanced where, one programs has accelerate. and fall think data the we’re clinic, to urge clinical this we those I the This that want are target, presenting real put attention data pay are one

Operator

Evan. you, Thank

Colin ahead. go from Please comes UBS. question from next Our Bristow

is line Your open.

Colin Bristow

especially you light thanks TEZSPIRE, curious to just a COPD just afternoon, quick and questions. success, your the data for in as was in [indiscernible] the recent the have sort positive good first clicking get I Thank Hey, one data? of for the of Maybe on you. What’s expectations upcoming the half here. and very XXXX. of threshold

Bob Bradway

Yes.

think I seen in the what we’ve is love something that would in with competitive that. see field, to we light of

target patients may be Just TSLP detected that everyone, to for the is expressed and the here. set testing level bronchoalveolar this bronchial TEZSPIRE, exacerbations is mucosa. are with the The really COPD. of that can contributor that’s driver study we of a pathway rationale hypothesis or in fluid lavage in Sputum be in

hope totality give So but see. you’ve things we’ll data, we’ll recently the seen some as of what benchmarks clinical at the to think I look published of us the to

Operator

Thank you, Colin.

Our Raymond next Please Dane question comes James. Leone from from go ahead.

line is Your open.

Dane Leone

see think favor TRx suggesting they’ve to coming seems that sense steady the good just during that makes for be half just you from achieved those in side. rebound this terms response state strength of share is whatever you two back periods side Thank you. of oral to of the the share some ones Otezla you Maybe Otezla provide firstly, in oral or side back for quick the here and competitors’ could me; whether on your year, on competitive and out over on the topical Can out? trialing products also and would analysis in XX% maybe go that something of of

And less – we X or population maybe to tarlatamab, in cancer Phase is the opposed X Thank patient need sometimes then cell that what secondly, just is X seen study, lung pre in aware of regarding which as anything the small there Phase was Phase the pretreated maybe heavy study, case? to heavily you. less was be this the

Arvind Sood

we take Yes, why parts? it don’t two in

Bob Bradway

question. to attempt Otezla I’ll Dane, Yes. answer your

encouraged see can’t claims we the said, me As we It’s hard companies, to what other in program. really here. particularly their market share free can that in comment we see versus adding what when from what I drug on they’re seeing are for we’re market by

including and have access seen the actually where think ultimate programs a denominator of programs will market product their and of not that access they’re they’re don’t that be they’re performance lot look representative ultimately many what that that’s away, because in share. when effect final we’ve new categories think giving So on going final providing their reflective picture bridging or I are will picture in I in to like, free demand. the of

those authorization So, I requirements to patients access insurance good into little prior free happen. but our a that getting the in for go-forward, broad end coverage, could position of are given coverage. have plans, of definitely think should with those coverage across up it factored we very rejected drug we no sustained that many Because our not some actual of

Arvind Sood

Regarding tarlatamab, no substantive We’ll differences, population. pretreated very our this details provide heavily fall.

Operator

Dane. you, Thank

Please ahead. comes Risinger Our from go David question Leerink from next Partners.

is line Your open.

David Risinger

please you of your discuss oral Yes, evaluation thanks candidates? X and very very an update obesity on much. trial, Thanks backup Phase your Could much. also provide

Bob Bradway

moving Yes, dose obesity single program, which short-term multiple it’s in through, and dose. X, terms the oral includes, of Phase it’s

based. them towards programs non-incretin to here. of start give first And at we’ll as of we to some multiple into our of those now about half and in orthogonal We approach mechanisms the expect next probably Behind insights have that you them data action, clinic, of talk progress looking portfolio many year. have the

you. thank So

Arvind Sood

allotted don’t we our take Hey, we why one last are as time? question Julian, over

Operator

Certainly.

from ahead. from go Karnauskas come will Securities. Robin question Please final Our Truist

Your line is open.

Robin Karnauskas

you. thank Great,

make like these think Harpoon, inhibitor you landscape And than combination the on can from congratulations of that walk just even how be us tarlatamab, competitive today. what like innovators are cadence going we checkpoint in when So market life particular, bigger like the my much. Thanks trial, cell easier. them? see think first you expand little small so to a But opine usually much how X view the call you trials the bit, through a could differentiated from I’m and TMAb of do to or people data I to and first, Phase

Arvind Sood

Sure.

let always, muscle of with about as everyone about level me this talk this I’m the one others is behind molecule, know, start set But, you extremely that sort Let here. enthusiastic one we’re tarlatamab putting molecules. I’ll [ph]. really to their

them to unmet each start about cell Europe year. are roughly of the lung need, United in in cases of XX% you are example. think the medical States cancer, lung numbers As for cancer comparable small XXX,XXX Roughly Western there

is patients. you The So clinical numbers. development sense swath broad a designed at of program that patient gives the really of to that to overtime going be look

quickly our into is but here to advance and second lines of earlier in course, third-line Of starting therapy, goal we’re treatment.

talk that, those we’ll more when about into we of where affect as through think observed settings as later this disease. cancer five we’ve get alive really we the And think with clinical BLINCYTO, And, can studies lower I But we now. the will that X% years is again, in diagnosis, the natural be opportunity only small cell history the lung that’s upon later. burden I get year. of with front of is in initial tumor of patients to Recall us one change

Bob Bradway

for thank you question and Okay. Robin, joining. thank your Well, all for you

respectful that Sood VP want a this And I over his Arvind break, we into announce role IR new will Justin which to transition nearly want I before minutes role. will just XX I be years Head allotted if after Justin wanted Treasurer, more Finance in we’re the transitioning to statement, said, to will seamlessly in Claeys. know of responsibility of make our also remain Arvind Arvind be calendars, and couple help but a we so time, is As I do to may, one your

and investor it he fixture is while moment relations this is, to world. I of is legend he acknowledge because know a the and wanted in a big something a nonetheless So Arvind is leaving not I

add XX years. that I to for than note, – more worked with And a just on Arvind I now want personal I’ve

Amgen. together began even both we working joined before So we

congratulate the I profession. of him delighted his And team. going to I on the publicly So to of remain IR group to again, accomplishments Peter part and finance working I’m rest the want me want that he’s publicly with the that in and state

we birthday, of celebrate, a years role Amgen. his nearly is his in the at which culmination thing to So on have second XX

been who years. getting of know him. more for enjoy the you, Treasurer and XX haven’t served met He’s with of to past years Justin, And Amgen as will those for our four than most

as I quarter. me you’ll wishing me begins in wishing this he in Justin you with join Thank So role. I here celebration a all you’ll good And to know this join after Arvind the later you. well his us transition know into all evening. We’ll talk next

Arvind Sood

you in Thank touch. And Great. everybody. keep we’ll

Operator

This concludes earnings our QX XXXX call.

now disconnect. may You

Amgen (AMGN) 3 Aug 232023 Q2 Earnings call transcript