AMGN - Earnings call transcript Q4 2024

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Operator

My name is Julienne, and I will be your conference facilitator today for Amgen's Fourth Quarter and Full Year 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.

Justin Claeys

Thank you, Julienne. welcome fourth and call. XXXX everyone, afternoon, to quarter our earnings Good Jay Griffin. Through this Bradway and today, describe our performance materials review Gordon, call lead we the performance reconciliations within and and followed Murdo Bob financial the our broader will be use will measures our course the of by call. non-GAAP a by have accompany Bradner discussion appropriate Peter to that of provided

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

Robert Bradway

and for year Good thank afternoon, capped at XXXX us another everyone, strong Amgen. execution you joining today. of

supplied teams operations Our patient every time. every

across Our delivered established and portfolio, results areas us our geographic our in the clinical each the XXXX of business business term. The our across well we've X quality that reliably for operating rhythm and our therapeutic commercial teams serve and will regions. in the teams grew longer

objective long-term and losses our to prices ahead, deliver exclusivity. net navigating growth regulatory political declining of is Looking and change, while

a doing have track just record that. of We

past and the products accounted [ year decade, revenues. X% for the XX% per grew facing a mid-single-digit revenues consider across percent at level ] you If over despite of our period approximately generic above competition and biosimilar EPS we about that

discipline $X growth the fourth each drivers patient the our operating look will for while to several our in deliver patients we a products in demographics annualizing billion. rapidly meet address quarter enable are through exited medicines expect the aging scale to that of to we of As notably, and XX of to key positioned the shareholders. Reflecting these next with novel on us medicines decade, be well And decade. marketed needs continuing our world, at we to our to over XXXX,

Repatha, now of EVENITY Repatha And access a deliver worldwide. as disease Heart continues to a leading Let the cause medicine. me general product, in death continued expand remains highlight and to improves few. Starting globally. growth. attractive multibillion-dollar

women. In is addressing We the it risk will with we EVENITY launch intend osteoporosis. making prevention of new indications of further into look for are the can The chronic role those of continue in internationally be since approvals rare health, living growth respiratory of exciting performance third indications, Phase UPLIZNA, including in rhinosinusitis, III by for where the strong cause TEZSPIRE fracture inspired other advancing XXXX of of inflammation, leading disease an which we're be trajectory progress forward postmenopausal the play the death, reducing for need bone the demonstrates leading strengthening our and performance we We huge the diseases. and business. In COPD, leader diseases, worldwide launches year. with to to for its rare in new to millions fracture regulatory in which TEPEZZA initiate course, in clinical studies; and

for milestone programs advancing readouts disease, small portfolios. our and [indiscernible] advanced rapidly important and in rare including cancer. XXXX advancing III medicine, Phase across for promises into hard-to-treat lung inflammation our III Phase with to another be pipeline xaluritamig cell year prostate general data oncology

across our manufacturing Beyond and conditions. This with these related time leveraging is and the an several new be trials facts of innovation in for science and MariTide Phase the the readouts, new we'll our III and initiating depth medicines is in exciting in obesity in laboratories, AI business, intelligence, innovative across opportunities company. deliver of technology power of the helping strength of and comes our our to we're our business, portfolio When more us patients. finding the it pipeline. to artificial our

our their innovation to our want poised for I'll update beyond. dedication exceptional term, to thank global turn into organization. an And deliver step Murdo over for in to on continued near in our to we I and team it that, growth the through commercial mission. With contributions As we're and XXXX, XXXX

Murdo Gordon

year-over-year, year grew the sales quarter, capping off product the a business. fourth of In strong growth Bob. Thanks, XX% execution fueled across by

grew digits for XXX and The States, effective for growth Repatha the impactful XX% treatment the Repatha strong are around patients and sales by or in we major by care in growth large sales increased the strong XX of of of like patients the availability for which Repatha growth growth their indicating grew for the as United product the in in strategy. growth are strong number XX%. robust cardiovascular patients in future in risk physicians, are setting. therapies, For year-over-year XX%, with on need and XX% improved momentum primary world double potential investment accounting XXXX, increased for growth LDL-C. supporting physicians Repatha see over patient patients recognize important volume $X.X are growth LDL-C There untreated the creating by on in Repatha serve products nearly better, majority grew importance therapies of year, focused events. In elevated billion And in $X products XXXX these lowering growth volume grew of XX% primary beyond. Two brands in of and our trajectory million the And XX% globally together XX% care with of and full at sales. XXXX, payers sales prescribers EVENITY, of mostly populations sales of highly a year. XXXX that Both potential. Repatha billion despite driven reaching

seeking see authorization recent doctor grow doubled segment. and of further X patients. Repatha versus direct-to-patient or number more physicians competition ease survey Repatha Cardiologists making that increased Repatha improved has and barriers, the primary for continues access by Our supported Volume significantly more affordable efforts reported their access for ago. Outside patients Repatha. payers remove and U.S., Repatha's broad and was across growth in despite prior care ask to who education even the in markets accessible years reimbursement, the major a to we

the of markets new world. been around Repatha has the coverage price impacted the growth by U.S. of of years, the expansion several past the an Over and in

in play date, surgeons, towards TEPEZZA to from additional saw U.S. growth launched expect reach year, XX% be we've them, not almost in the increased bone active first of and new In and Japan, focus eye to who significant and force XX% X% XX% quickly the a eye are sales. representing leader or of for U.S., billion over and generated in strong millions in by bone eye Moving year, had rare largest continues see disease we uncontrolled benefit drive impact which We broad could price the treatment, and grow of customers patients Despite XXXX women $X the XXXX. forward, TEPEZZA, only year-on-year unique severe, of the supported by portfolio, to in been field reducing ophthalmologists billion We've to asthma. driven patients drivers. a treat disease for volume XXX,XXX billion the appropriate increase. in in our the regulatory launch, by EVENITY uncontrolled beyond. In strong receiving a XX% of the net And a for billion medicine with XXX,XXX opportunity disease. reaching very TEPEZZA in and engage for to treat are only to to TEZSPIRE risk treated portfolio, in in expect future profile fracture sales Repatha year-over-year shifted in significant which living we thyroid the with move and product triggers decline suffering inflammation, with increase disease. mid-single we've bone-builder markets given both who prescription of $X.X in treat need ordering EVENITY a market. $X.X million the that sales TEPEZZA We've in patients has and trajectory resorption, TEZSPIRE's slows asthma an countries. In segment rare increased the role TEZSPIRE nearly builds its prescribers. our increase oculoplastic from potential in a the price critical established fully from less. EVENITY over EVENITY new successfully risk. therapeutic where Since has X thyroid our EVENITY TEPEZZA multiple, approved base disease we sales launch which There can the erosion our with high-risk adoption additional in to TEPEZZA, only international in at quarter-over-quarter EVENITY increased patients postmenopausal. both growth. worldwide XXXX, to severe, have to will U.S. sales in XXXX, U.S. remain with to secure have our investment X.X patients XXXX patients in positive and currently moving EVENITY. I'll thousands in pulmonologists efforts EVENITY delivered roughly drove EVENITY less growth. endocrinologists. We're continues expected intensified With is to approval digits the prescriber thyroid while of it's millions need, $X.X

almost Our by XGEVA sales for Vectibix, selling growth XX% innovative billion grew including volume contributed sales oncology $X Year-over-year portfolio, net LUMAKRAS, full IMDELLTRA and KYPROLIS, and in BLINCYTO, the Nplate, price. year. higher driven

critical BLINCYTO unmet reaching developed $X.X grew to providing in XX% growth. BLINCYTO continues T-cell year, oncology future significant Our address opportunities for for platform, over leading engager needs IMDELLTRA, the and in billion full bispecific sales. which sales while

compelling and in and growth Physician prescribing community expect academic Philadelphia is care prescribing BLINCYTO adult XXXX the is ALL. B-cell and strong pediatric with broad clinical new as data continued patients standard We by both for driven of chromosome-negative redefining growing, segments. across

community of breadth progressing extensive-stage after sales off XX,XXX or patients clinical an of start, generating increasing are progress extensive-stage Our IMDELLTRA transformational for cancer lung IMDELLTRA to chemotherapy settings since estimated both We to small launch. months X,XXX cell launch. launch by adoption patients approximately on has cancer. cell since for strong see X to of for in with million patients $XXX IMDELLTRA's treatment treated strong efficacy. treatment lung X,XXX second-line and a in in U.S. academic who the Each small is driven conviction year,

and robust growth launch the to our administer retina execution January, next wave across of in quarter, that strong with patients as With launches, in coordinated expect Wislana, million. bring we portfolio. XXXX X $X.X In XXXX, year Solaris. with view an fourth attractive a strong Pavblu And of to of totaling biosimilar disease. Sales We a second of execution anticipate billion of from IMDELLTRA high-quality and on launched commercial our this positive to team launches we year-over-year. biosimilar to STELARA. wave $XX of a a biosimilar been quarter, and Our sales to an effort EYLEA, with at was in this returns of we operating next prefilled Amgen teams integration us ability products biosimilar teams in our weeks the XX% the to XXXX. And end This specialists tightly to team delivered very portfolio and even our intent syringe. The BikeBia In purchase and of manufacturing enables with and continues serve operations biosimilar urgency record building were medical easy-to-use it readily hand to medicines relentless in living will the the to increase cross-enterprise Pavblu, between aggressive development, this patients our with with biosimilar over focus across the research launch numbers Response more patients I'll accelerate are strong commercial to XXXX. the world. Jay. executed Amgen reach of more XXXX, Pavblu biosimilar of introduction around from that, to Amgen. has

James Bradner

last afternoon, year, very almost value say good I'm and meeting planned proud exceeding to generating the targets At very everyone. Murdo, across all and we R&D time and ambitious or this impact you, we and portfolio. agenda, delivered, Thank a enrollment

regulatory the Phase approvals oncology, in in important Phase X while III initiated broad new Specifically, MariTide positive trials studies X received advancing XXXX, program. completed and we X III

a data enthusiasm with our therapy current loss Let's key sustained This engaged compatible or unique, a have weight weekly clear hitting XX we excitement dosing, advantage and weeks less received stems monthly for have highly a strong a and weight without predictable convenient opinion Since II and differentiated disclosure and plateau last profile. support. over begin loss leaders and extensively November, consistent, with to MariTide, with through Phase deliver MariTide's ability therapies. frequent

in related improvements MariTide management key and conditions, conveyed expect set schedule major hemoglobin health year, in significantly simple fewer clinically a treatment studies parameters, demonstrated we With Phase at AXc, Phase people study with congress. part data the are MARITIME half III long-term first opinion by the and Additionally, and their further X for promising its including type committed readouts full present dose-escalation XXXX, data first optimized we injections meaningful potential. In half advance leaders excitement robust the Phase and ongoing we outcomes. diabetes weight improve treatment. a to to XXXX, living of MariTide to per and we persistence realizing the fully of Phase ongoing for represents obesity key expect and to expect II X our initiate medical expect II the from both II study. of In a program broad second MariTide and cardiometabolic chronic

look at III additional second prevention medicine, in to half event. cardiovascular Repatha these we're the primary of forward year. and about setting, MariTide, and patients to demonstrated risk profound data first in from VESALIUS Beyond benefit a general the the Phase we excited of of in prevention reach Repatha study this Having sustained the secondary high data opportunity

The and continues bringing Lp(a) are in progress, additional disease. the risk outcomes trial Phase elevation. a olpasiran, expect a an Phase medicine first study to medicine enrolled to half we first small the cardiovascular OCEAN many XXXX. Shifting this cardiovascular with best-in-class, Lp(a), III reduction initiate for at of individuals late and patients of to for in precision high to to we year RNA Lp(a) or our Turning rare cardiovascular promising fully outcome event olpasiran A with III risk elevated interfering targeting

X, myasthenia in this later be on anticipate FDA provide from the on with insight PDUFA about patient-centered excited The no management generalized approvals about now MITIGATE clinical ever further to horizon X XX-week eagerly disease date UPLIZNA's are the III multiple generalized a from with expanding need illnesses. on With into also IgGX-related data and inflammatory we a In priority IgGX-related compelling data long-term MINT XXXX, with more than diseases. In This also of the granted We inflammatory of anticipated outcomes, remain study the will data highly review and response to condition year, for UPLIZNA's gravis, serious are treatment the inflammation, gravis which impact FDA rare durability. generated therapies. myasthenia confident more on UPLIZNA based dosing. We designation we very track than to facing the world's disease, drug and third cells patients upon inflammatory severe study Phase for studies of even about are of counts with is the patients or we're data approved equal to very impact have potential patients we steroids under in in III XX-week TEZSPIRE showed in III to effective XXX with initiate TEZSPIRE reducing could with XXXX. Phase death, convenient study. UPLIZNA microliter. These COPD, April the a Phase eosinophil UPLIZNA moderate per serve targeting cause greater COPD COPD excited this the of to setting. bloody leading rare

polyps, continue insight with deeper study eosinophilic in is Phase Beyond Phase COPD, in throughout dermatitis rocatinlimab's profile. studies chronic nasal supported provide III III III And data regulatory into progressing in additional XXXX. underway will rhinosinusitis esophagitis. The ROCKET These we by program data. are with a Phase rocutinlumab expected submissions atopic positive advancing

we a continue condition by chronic to asthma and in extreme characterized skin nodularis, Beyond explore dermatitis, moderate-to-severe atopic itchiness. rocatinlumab impervigo

B-cell are autoimmune we indicated, with blinatumomab disease previously in both pursuing and inebilizumab. As depletion

BLINCYTO Medicine. rapidly focus acute alone I compared Our systemic of ASH lymphoblastic with disease-free advancing BLINCYTO our chemotherapy leukemia. Oncology oncology, lupus in a XX% on with an expect into to New Journal at readouts. additional upfront Last to the treatment Group, in will in with improved Phase exciting III by added initial portfolio. England Phase expand plans data to X-year III and key indications. XXXX important shared very arotymatosis survival pediatric data X year start will December, where to chemotherapy is we study conducted the be XX% BiTE simultaneously published B-cell the of In Children's were

to potentially advancing has Based efficacy patient our improve to We experience, are blinatumomab potential date, adults experience to in a a formulation relapsed/refractory subcutaneous also of and on tolerability. study and B-ALL second with the expected XXXX. subcutaneous adolescents of blinatumomab with registration-enabling the begin in the half

rapidly a are second-line, chemotherapy cancer, extensive-stage, are Our study limited-stage first-in-class into extensive-stage and of engager second III disease. DLLX both in therapy, therapy. approved This Phase small small earlier Delphi ongoing of lung XXXX. half in the cancer. expected is BiTE for IMDELLTRA, in lung IMDELLTRA from targeting XXX advancing first cell compares cell studies with T-cell bispecific Data lines standard-of-care

Our first-in-class STEAPX entered has study development CDX metastatic prostate castrate-resistant in with bispecific xaluritamig, III T-cell post-taxane, cancer. engager, Phase clinical a

prostate cancer to growth opportunity in lines and xaluritamig excited IMDELLTRA with about our of additional and xaluritamig. exploring also reach BiTE are of multiple We BLINCYTO, Ib therapy Phase patients earlier and the the platform in studies combination We potential ongoing. cancer with remain

engagers, antibody, therapy. frontline gastric fibroblast first-in-class growth is T-cell cancer advancing our monoclonal our IIb-directed bemarituzumab, factor Beyond receptor to

year data the OCREVUS, illnesses to an XXX, highly it Opdivo, half their We combined I study products. In chemotherapy commitment to evaluating and XXXX, III in III next Amgen of from Peter. facing for of my ahead with and patients bemarituzumab pipeline second FORTITUDE-XXX, biosimilars unwavering to MFFOXX over study nivolumab. On bemarituzumab of momentum. I'll X the and Phase from our We turn throughout productive their we look of want wave to of Amgen a analysis to combined colleagues chemotherapy chemotherapy collaboration KEYTRUDA forward a and rapidly and biosimilars, Phase FORTITUDE a XXXX expect the XXXX. versus focus first biosimilar thank grievous closing, Phase data expect continued an for exciting of programs now III are with In we alone. half advancing

Peter Griffith

deck. Full long-term objectives. shown Product billion excellence We're record products track the sales XX% our quarter XX% full The remain growth. and the driven driven XXXX, financial for execution our year-over-year with grew pleased $XX.X year XX by Jay. on are the of slide increased fourth you, with results to and revenues Thank with in on year sales. XX XX% year-over-year of by Slides XX volume total we

product the year-over-year X% increased sales Excluding products driven year by full from XX% acquired Horizon, for growth. volume

non-GAAP For the delivered margin full we operating of a XX%. year,

We XX% late-stage a and record $X.X as continue advancing programs. the year-over-year R&D to billion bemarituzumab Horizon-acquired to to non-GAAP increasing including with as pipeline well IMDELLTRA rocatinlumab, investments invest for spend full year MariTide, pipeline, our the due in in

X Excluding and cost year-over-year. progressing integration EPS non-GAAP post year to increased previously accretive almost the the spending was is announced acquisition. XX% acquisition. in billion R&D due by expense The expense well, Horizon, reach million pretax The XXXX. $XXX we to year acquisition expect Horizon non-GAAP the and from up increased Horizon $X.X year-over-year, was entirely other Full synergies income year non-GAAP for full to interest

continue sheet with XXXX. We in retired balance debt to our billion $X.X strengthen of

tax quarter. the for with percentage flow in the and business to to the paid line including results full the earnings collections capital business in cash year-end. We executed net to be the addition billion decreased free at strong and in non-GAAP cash flow points the change the billion expenditures of due Our with Horizon in fourth reflect in in guidance company the and and free for year-over-year in cash full in items. billion, provided, $X.X being primarily of of $XX.X favorable These XXXX remainder favorable timing XXXX. the rate $X.X X XX.X% momentum year mix, the outflow $X.X billion generated The year

development, discovery our responsiveness Our enabling informing and enrollment enhancing molecule and commitment customers faster the in artificial as streamlining including and is chain, across also to trial research, in to regulatory clinical we innovation operations. filings commercial intelligence design value evident deploy

a we This increase we to the X% dividend returned share per shareholders compared $X.XX XXXX. addition, competitive to as of in represented fourth In quarter. capital paid

to dividend. we will increase expect that our We continue

the for Slide Let's turn for business XXXX XX. to on the outlook

to in $XX non-GAAP our share the earnings and expect $XX.XX. between We per revenues total of billion billion and $XX.X range $XX.X XXXX

growth driven Our by each revenue of opportunities our strong range therapeutic across reflects outlook our numerous areas.

in more biosimilars. TEZSPIRE; a declines our portfolio; patent We growth XXXX. number oncology price denosumab disease across as expect will portfolio This near-term our expiration EVENITY, by products, offset portfolio; upcoming continued continued than led growth well to due as declines the across of drivers, our innovative Repatha, and rare growth our

quarters. to total A growth first as rate. revenues, expect XXXX you ] we historical XXXX first Enbrel we vary and and in have patterns. model follow first pattern Otezla quarter trends, on sales subsequent For year-over-year depending quarter-to-quarter, a to of our with [ typical quarter their similar expect sales in the quarter to consistent the Also relatively company the ordering note of reminder and relative significantly biosimilar customer lower U.S. that of can

be For in example, sales XXXX. expect AMGEVITA we QX in QX with U.S. to the line

For pipeline, driving revenue expect including the our late-stage full MariTide other year, support to investments In to approximately promising billion. and R&D olpasiran. $X.X are be XXXX, we we

result, be XX% As cost in margin project a to product reflects the sales project non-GAAP roughly we percentage the a of profit mix, impact projection sales percentage sales operating including range year royalties. to to the of We sales This XXXX. as a full non-GAAP product for ongoing XX%. of XX% as of and be of share

non-GAAP margin [ XX% investing ] the in of approximately lowest hub technology We quarter. best see in commitment we operating organization. Consistent the We mid-teens year-over-year increasing years the and then our anticipate following our significant We in also innovation billion the with prioritization quarters execution as $X.X Overall, R&D with and X product the efficiency opportunities. And automation we the across to these innovative and the both spend, and SG&A XXXX at be percentage while to points prior including in to sales XX% we excellence, the of in indicates percentage non-GAAP now margin full prioritize sales of in unlock each key by expect non-GAAP it OI&E amount be resources, innovation in X fully pipeline continue accelerate QX, important the efficiencies roughly we olpasiran. approximately operating QX and and year-over-year assets, and as to in to established with to XXXX a India. decline driving potential our expect to to the year drive pipeline, is lower leveraging invest XXXX. strategically that investments for product typical line year including newly to of first in expense advance MariTide grow expect non-GAAP

non-GAAP a share Similar quarter first XXXX, of XXXX. expect XXXX we rate XXXX, of share we and to count to flat expect expect of the in quarter be tax We not $XXX the exceed to repurchases the to XX% XX%. in fourth million to

of in expenditures capacity XXXX. and $X.X capital is approximately allocation billion pipeline. with business expect This consistent and invest our growth priority products for capital We in scale to our the in marketed

tax to cash remain ratings We structure expect to by expect investment-grade and shift by XXXX. In to be quarter will strong track XXXX. strengthen flow XXXX XXXX free of expenditures. payment the of on $X.X XXXX maintain cash in flow, to as strong repatriation the similar the XXXX, final driven capital free in tax generate XXXX the strong we second capital is of the credit working impacted to capital billion first also payments collections and continue year-end our by primarily half our decline flow in Free and This pre-Horizon balance XXXX the favorability be sheet to we performance end timing, return to quarter incremental of second cash XXXX.

outlook colleagues concludes our I'm remains serving hand to Q&A dedication patients. for long-term update. I'll now session. to it and Bob financial strong, Our our for our This worldwide to grateful back their

Robert Bradway

Okay.

billion. with our over results repeat, as recap XX products our at across XX delivering we products growing had double-digit you Just Q&A the to session, sales can record and $X before opportunities products rate depth And at XX fourth for exited the to sales. of see, annualizing quarter highlight business. we the and the to year, breadth we go And

we'd take supports our outlook So XXXX to long happy with the this for through momentum be and questions. that, term. And

Justin Claeys

of remind you please procedures our participants if could the Julienne, here.

Operator

comes TD from from Our Instructions] Cowen. Werber first question [Operator Yaron

Yaron Werber

a secondly, that? obesity, What just on? an now Is of XXX, And things things. strong clinical couple that AMGEVITA was Murdo. or X A at incretin mechanism? XX. extremely just really from On hold for for few maybe drove strong. one on was sustainable non-incretin that's looked you then Maybe comment, the can that

Robert Bradway

take do in I We'll to parts. Jay, All address right. want is. it the X think you it XXX,

James Bradner

is for I patients It's a Thanks, Phase currently obesity. Yaron. AMG medicine XXX investigational novel investigation. in with

This disclosed know. We of as remains action. space, mechanism the competitive have you not a

Murdo Gordon

We're this grew I is we're biosimilar as Murdo And grow to here. year about portfolio we going last XX%, Yaron, performance. and And that mentioned, biosimilars portfolio, with forward. confident can pleased continue our overall

of -- those which will be of contributors growth One AMGEVITA.

Justin Claeys

next the a go will have Great. question. Julienne, I we'll folks queue remind full quite today. we to

can to one that So great. if question, would you limit yourself be

Operator

next Our Courtney from question comes Bernstein. Breen from

Courtney Breen

well evolving to the about about injectable wanted later Obviously, Merck's and new oral scheduled out coral space. also of prevention in PCSKXs bit a in seeing as efficacy. of that terms There the ask market trial the as of coming, we is an I kind a think just read seem about this perform suggestions talk Repatha. as year? lipids you you to reef to we've this be that, bit there Can indications little little could there's and that primary growth particularly strong kind how anticipate

wanting to how would position. understand you just So

Murdo Gordon

U.S. some Yes. Thanks, and United very in to And of Repatha outside in Courtney. the see expect very growth we with performance in both both and volume pleased continue. the obviously up the States. We're of in XXXX, putting revenues, strong that

treat able of the We patients millions have LDL there's many cholesterol to their to patients. who optimized, expect these not be millions had and upon

the reimbursed offers that scratching to prescribe are and amongst to What comes prescribers we're successful surface now and is positioned that Repatha the been pleased it. about really And we've appropriately perception and it affordable for easy-to-access our them. And and is on receive a treating Repatha access world thanks we removing ideal those when medicine, medicine sure We prescribers efforts to for formularies solution really is the think it barely that patients to an of an Repatha that's barriers. teams with PBMs. making around the in

cardiovascular very, good that new in heart reads needs other you are actually out Repatha we momentum just And of that feel can really to and or point demonstrated at a here. course, we'll the later to introduced the LDL strokes attack respect to very stroke about we show secondary year, heart be sequel. of has goal, inflection you and Repatha's sales, is attacks, first So this there's as with evidence the in risk which XXXX. With and clearly be mentioned, than that trajectory the prevention established event. cardiovascular performance lower other benefit that able cholesterol-lowering an or of obviously, in competition, more

of we're and LDL. of not kind -- we're market in now this mode just the So hard endpoints treat in lowering helping

come But evidence this market. but future. So with us how accumulates we'll very into now again, the for other notably, and just orals, driver not a what it see is the competitors the into Repatha trying is growth are to and important that

Operator

next question Richter comes from from Our Goldman Salveen Sachs.

Salveen Richter

context guidance, where XXXX how Part can and to your D you to the projections? factored speak growth underappreciating The discuss your the Street redesign of In you sales is feel in you

Robert Bradway

don't first and redesign Let you it why X me in pieces. then, here? take D Pete, why on jump don't Murdo, Part in you start the

Peter Griffith

Sure.

Murdo Gordon

to for total Peter? pocket an at products Repatha and we The when care relatively that's level D is like a patients' Yes. portfolio out like is redesign Part between tend for what products [indiscernible] forward. capped of do at And Repatha happen us believe going price will well some cardiovascular affordable chronic neutral smooth.

Peter Griffith

is you blockbuster XX or the Salveen. question. double-digit strong end-market Murdo, more growth or XX let's thank portfolio, XXXX, that just at XX were with Great. XXXX, annualizing for would and thank you $X I which said, of over products so in status from XXXX what remind we've Salveen, start records billion -- you. in products

about ] at look to we Repatha. about, [ when think So talked Murdo XXXX

price this So people XXX about maybe He strong or he treatment, world access as digit coming needing Visalia later talked that. this year around less year mid-single the is on globally. less the said, erosion, and million

Repatha EVENITY, it's a medicine than forward. And going the So need continue the unmet low there's strong on penetration. XX% we U.S. to to And a Greater second the expect be significant there treated. of got patients been EVENITY. with single-digit high-risk haven't in

$X XX% those share up XXXX very are think almost let me So we also in very, TEZSPIRE, important. But X billion. to

to these with patients it very oncology hematology think this We XXXX. $XXX then innovative X to we lot cycle X, oncology, growth $X.X portfolio early there about opportunities. we and in XXXX. to lot XX% XXXX. And year. sales. up to in Rare products, up think about about think they've you coming that's a and oncology in disease, shared launches and the $X.X billion a Innovative see reminder, we when ways was I a a help product strong to with products get got of of some are got up those so life XX%, go. growth biosimilars. disease. We of We've have And But we billion million a

that. to And see we lot so in of growth continue a

lot XXXX think denosumab. we this to continue strong opportunity I my, and way expiry in there's as of business in in a grow going to So And on a forward. shared

most with patients more very we're the around leave I'll but to And expect XXXX there, in business. it the world. medicine pleased So more we importantly,

Operator

comes Our David from next question Sandler. Amsellem Piper from

David Amsellem

road? you're the So biosimilar competitive for get wanted thinking the how products. gears Horizon to how runway down And TEPEZZA? the the also thinking and the landscape potential and KRYSTEXXA, thoughts you are of switch for there your then about growth about some on

Robert Bradway

Murdo, you to... Sure. do want

Murdo Gordon

Horizon from I we you, TEPEZZA, Thank up XX%; performance the David. X%. period, up XX%; up prior TAVNEOS, -- the include was up Yes. KRYSTEXXA and had UPLIZNA, KRYSTEXXA, XXX%; if

a flow life mentioned, data on is of overall, is it's IgGX XX with cycle So their Peter -- data case, on course, with and of very this more our in data GMG UPLIZNA additional with as products coming weeks. as early portfolio to the

uncontrolled our many not have of the again, is for is TEPEZZA we There severe well catalysts overall, approval condition. It's disease. the is the course, catalysts business international So underway outside of which expansion, that immunomodulation we KRYSTEXXA able of and portfolio, recent to rare disease And the respect those patients. rare to will with now launches KRYSTEXXA not U.S., a have grow U.S. are of part there in gout though patients of continuously. are then in a Japan. With who rare we growth a our number suffer with of and data, even lots help out with,

assets. And see growth to for additional And so pipeline we we're develop robust also continued there. opportunity looking

Jay those and looking his at so opportunities. are And team

Operator

comes question Yee from next Michael Our Jefferies. from

Michael Yee

MariTide, couple And early on than maybe seem seen your like be X orals? you'd MariTide. a some of view Other you are you asset in to confident years, to you strategic portfolio, be slip-ups. obesity about stage assets everyone's multiple of X comment including or MariTide, have given where so if pretty had outside Can about that you've a

So maybe just the can to and add comment you whether about your there appetite portfolio.

Robert Bradway

Sure. Mike, programs. I'm of premise. not anyway, sure the But obesity Jay? ahead, accept we let's about portfolio talk Go the

James Bradner

at not Mike. high a that go Amgen these what medicines to forward, investigation up clinical did Akin at what and Early next Thanks, Yes. meet slip-ups call I really has medicine bar. bar here after said, all. wouldn't MariTide for the Bob

fit with emerging generally, disease, and very our well care. cardiovascular nephrology, efforts in presence strength obesity Our in more primary the

be rising confident ideas integrins, decade. The major early that talent for all capabilities, in non-integrins. for pipeline and the And we're to more obesity we very time, research of a which so a medicines also fullness than we've the have studied has player development targeting and ideas

others We're partnerships medicines have also administration. by external We will that innovation. orally, be through open given subcutaneous interested to

the MariTide So in and pipeline behind we're in very confident it. very confident

Robert Bradway

the again, Jay, obesity clarify still drug, the program the that. We product go to to the Sorry, about XXX -- usual steps believe development. previously hurdle. related that forward is was But are that that just to the is the portfolio. and out the The another referring longer still the we're didn't the expect we're excited so to no that said have coming clinic, referenced we molecules the he with we to it advancing regulators we'll clinic in But pass but that -- Jay of when on through thing. one was don't issue

Operator

Jay question from comes Olson Our from next Oppenheimer.

Jay Olson

Congrats update. [indiscernible] [indiscernible]...

Robert Bradway

you. we can't sorry, start. Jay, another hear Take

Jay Olson

now? me better Can you hear

Robert Bradway

ahead. Go Yes.

Jay Olson

lessons you from synergies you plan these MariTide? you Could you outcome any the expect those including can across leverage the Repatha-Visalia describe capture across to and results, programs? key to Okay. learn how lesson study olpasiran CV your portfolio, And

Robert Bradway

Sure. Jay?

James Bradner

I lot and like. already. We've don't from I speak a to Murdo, the to Why Repatha start and invite synergies Sure. you learned then

use in fantastic genetics leading a Repatha a secondary have population broad setup We of CV. prevention capability and for in epidemiology. And Vesalius is now the

this is study without cardiovascular As you Phase is patients, a more XX,XXX large high of III patients This outcome risk ongoing. or prior MI at cardiovascular placebo-controlled, know, stroke. than

the for expected readout understand be for event-driven an for large parameters. us the but second and outcomes in half of will LDL-C, have to further also valuable patients mine a cardiovascular to this to We of as improvement data set year. This other it relates

so it which Phase second is of as that an insights outcome, you readout We event-driven execution already and harvested from Repatha and olpasiran a the design next -- of III into have the expected has program, half heard many the carried in year.

valuable data set that very doubt, no prompt So insights. will, significant further

Murdo Gordon

be that III that Lp(a) no and to design diet given Lp(a). trial. I olpasiran do the profile understand Lp(a) of market, engaged are appropriate they in lowering presence substantial Thanks, think to leadership ultimately all that we're The we in being will we there's speed been But nonetheless, atherosclerotic to as when engaging Jay. differences, move mentioned trial some them the olpasiran the to and of Jay LDL that significant the with able for by the the is our be lowering We readout think we're be can the of different cannot though, share. lifestyle, and sure to There with going to branded make successful intentionality pharmacotherapeutic products the in exercise. clearly apply lowering available the stakeholders and that LDL. are and given do other here and have generically and lowering lipid of than has and for synergies results a lower that different it modified Phase available Lp(a) obviously have to

Operator

Wolfe from question comes Alex next Research. from Our Hammond

Alexandria Hammond

looking And appetite and on post the is more what guess broadly, innovation, So looking Horizon with stance your for more acquisition? to is now assets? overseas more I companies M&A for Amgen's China what for clinical-stage

Robert Bradway

position our molecules consistent, think come we -- focused on they We're add Alex. irrespective business we from. value remains can that pretty to, development on where We're of

we for around And So very opportunities. and had have acquisitions those active licensing and yes, for looking interesting globe. for we're open opportunities for all search business, maintained a the

Operator

Our comes next from Flynn Morgan question Stanley. Terence from

Terence Flynn

I all my in with X. say everyone quarterly X-parter the by area Phase on Just The had the employees devastating L.A. wanted wildfires. Amgen explored those a know to thoughts MariTide. part who's been doing you're impacted II dosing. I and

the there if Just MariTide interim Phase for there's schedule to. obesity full And decide tell was fair wondering the if us II is wondering of if data. a you Phase I if III look so ADA incorporate then that program can you into can an assumption you presentation

Robert Bradway

Sure. Jay?

Jay Olson

really the facing here Yes. the Thanks, appreciate area the and and for fires. call-out question these Terence, your for associates residents

part late ongoing weight that I an management. data of at in June II in expect the XX-week and our know, II chronic this Phase a is we X Part readout you to we as this have, We confirm That presenting forward Chicago year the there. forward in can and to year. study data look ADA Phase X you study, seeing meeting look

Operator

Risinger comes Leerink question from from next Dave Partners. Our

David Risinger

question. of of pipeline helpful simple provided sort a have a I call. Clearly, the on updates you've lot So

explain high-risk or why you're it's could initiated So initiating trial? patients 'XX? question, that 'XX today going new in be a is olpasiran to late not pending III Phase just What Jay, you early my trial to when announcing the plans until initiate is

Robert Bradway

in Jay, ahead -- speaking, context I the this can JPM January Bob Again, of piece the and you expect the year. clarify. in what Dave, maybe specific address like. question, go Dave, for I mentioned context to in just at But the it's of if the

James Bradner

add. Yes. No, more to nothing

to year. the study in of We total facing the this of commitment case, disease. intend risk We of genetically hope year hypothesis elevations protecting have already this announced initiate clinical prevention. investigation our to in a III half in cardiovascular benefit just a next in is this to the second initiate with olpasiran study patients -- We patients Phase a first for of Lp(a). to of this primary have or intention This initiate of strong half defined

Operator

question comes from Schott from next Our Chris JPMorgan.

Christopher Schott

more talk Just just thinking about should be are gradual U.S., specifically, we opportunity wanted how U.S. that growth in these those itself these in to think here? these and I we as the can new the we ex about markets? about roll rapid and repeating in Japan U.S. can some Or kind And out? the talk of and TEPEZZA ramps guess you of markets? internationally saw through the ramp

Murdo Gordon

it's in talking we're and patients, Murdo The physician of reduce site that the the Chris, Thanks finding right in here, experience significant care. patients to access about. to on friction TEPEZZA. Japan, XX,XXX model prescribers question In Yes. is terms care does then here. quite what epidemiology for access a the roughly the of Japan and

in good So United sure States during in this we because period. it bolus uptake we launch COVID was the saw to some that do market. have expect the impact pretty dynamic a a be Not there about the did that

I are compare patients of was I'm sure the weekly But So Japanese been last curves XXX there The good I showing have pretty ] at identified I end there. know already data the momentum. steady population. We over patient steady for prescribers. year. expect would of would penetration there the launch some [ not by

And for of growth TEPEZZA so Japan will a be good very source internationally.

do Amgen's regulatory that pending we'll that -- medicines on more in, footprint we for to bring As be these And catalyst growth I X for markets launching international the we've mentioned, overall U.S., And a got to broadening catalyst we continue TEPEZZA. things that acquisition, this to other brand. hopefully, the year, as of the the drove prescriber global focus see approvals. base obviously international the the for it's patients. In one ability

receive also ophthalmology So a and diagnose, a the thyroid the grades patients eye endocrinology as general care find and site of to for but then disease disease just not treatment. helping

the having Just portfolio a than their X and/or that the we does market. make in quarters, some it purchasing comment the in follow will our people I'll be other where reverified one other bit year overarching function first patterns a of quarter see this lower little on in insurance TEPEZZA, pattern mostly products

generate good long the that U.S. in for. term, the But So just international looking to and to given watch growth the is very TEPEZZA out something we momentum plan approvals

Operator

James Bank. comes Deutsche from question from Shin next Our

James Shin

Any MARITIME MARITIME start head-to-head as such color this And on or indication at will that not 'XX? against you on half the or point? first anything have the will incumbents in the semi whether say for chills tirzepatide can

James Bradner

additional on The James. management, type chronic diabetes, weight program focus on indications. sleep has and a Thank disease, Phase kidney X Yes. heart you, MARITIME failure apnea, disease, possibly III cardiovascular

discussions mature we the the rather around much these but a time, principles forward MARITIME talk to trials federal a it at very design initiating are with As would III our be look Phase regulators, premature to this through state at program.

Operator

Tim next America. of comes Bank from from Our question Anderson

Timothy Anderson

for $X as that years? of only the could sales why guys a its to I particular, ask market, know can't right, And what's billion-plus-type biosimilar in Amgen Pavblu, of seller product Street large doesn't guide I'd into it says give next The your that And get it commonly you the idea It us like biosimilar, for product this? to some the significant side few RIA so business, one can enough level. be that. get you credit just a for seems like about very for in XXXX

Robert Bradway

the grateful. beginning we suggested get at asking the that's very biosimilars. don't in enough If what said, we clearly for biosimilars. seems Perhaps Tim, you're about your you couldn't what -- question, but that of Okay. we hear do credit we're it you

want you able we're world Tim's appropriately what to objective to you be specifics, of when Murdo, has in a been And Pavblu. with we've reliably We biosimilar the as achieved But the the are market. leader, to biosimilars, our enter and amongst entrants, is address questions? wave supply that's and do to biosimilars know, focus first our as to

Murdo Gordon

Amgen prefilled Tim, with now. of being your is we're represents wave. are easy-to-use pleased being pleased available that on. The very give specialists in would feedback the But will positive. is course, Yes. say retina capitalize right to very talking the as in that We, the biosimilar is an biosimilar very we how to high-quality current mentioned, market that launch from find another a the They been enthusiastic, syringe. comments, We you always first given as in And only Bob yet opportunity ourselves target we've we that bringing very I try going. product-specific guidance. know, don't

And making helping done nice manufacturing that colleagues a have biosimilar. of these job number another that the and many patients device our day, of teams, specialists is to thanks we every path and each and very retina important. quite operations with Amgen they've sure more administrations process Given do our to very, development a legal

Peter Griffith

pursue Maybe shareholders bit, what build our XXX% sales with approval to we XXXX we date. to by Tim, sales we attractive we deliver the FDA XXXX manufacturing believe in over operations. through 'XX, an leverage the add I we And billion success and biosimilar I Amgen on is $XX on efficiently. end a just clinic. very biosimilar the franchise. that think in of broader would once earning suggest, industry-leading would including obviously We operate Bob, $X this. When double a billion opportunity, have of We cumulative little returns the remind enter an (sic) we to for to and We Murdo ] we're rate track decade. we're [ footprint, you

attractive I think deliver that returns. reinforces our ability leadership to and

of a it's So good delighted We're question. capital. important really and think shareholder this a we is use

Operator

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

Conor MacKay

sort to see any of market? are about competitive This the get on from quarter. And readouts the is readouts what the thinking just dermatitis several to Conor with balance the one on how Evan. coming over We positioning atopic your you on question looking in thoughts the had program. of Phase year, ROCKET for you're comfortable MacKay updated that? on Congrats With III those

James Bradner

OXXX receptor. targets Rocatinlumab, monoclonal the question. for verbalancing the Thanks antibody our T-cell

help ], efficacy this and with adolescents. rocatinlimab year, next first is or year. adolescent tolerability will with we your have with the the than of then of and the X,XXX the study, calcineurin We ASCEND number us program study. patients and moderate-to-severe is we granularity, question, study program. half in In rocatinlimab ASTRO. adults its study product X in As first atopic understand a in and ASTRO ASCEND studies: an note, moderate-to-severe safety AD. dermatitis maintenance adults And AD, with this of lot of half more out profile, patient gives IGNITE year of half study answer of in this data the topical reading of a monotherapy you target -- really moderate-to-severe in This around ROCKET [ SHUTTLE year. In to are this full combination we X-study studies data with steroids adults the

And information to as tolerability this profile. more very lot common generate about you of to better well contribute so in can for a the we're therapy many tell, cases, going of a as disease potential to the as a

Operator

Our next RBC from question will come Renza Gregory Capital from Markets.

Gregory Renza

team maybe a and could just I'm and penetrating about the longer just you commercial opportunity new partnership the BeiGene. comment you term, those your the and BX wondering if for factoring as oncology leveraging just being those the footprint opportunity into bit and that arrangement talk goals? about longer-term about China and markets, BeiGene with Bob, global that's just is into or medicines in namely, how how And

Robert Bradway

parts. Maybe we'll X take it in

Let which what just that said at beginning, reiterate growing X high is Gregory, to growing. are -- business of me the All altitude I geographic globally. the is our regions

is business rapidly our of growing now. Pacific Asia regions Japan, most Our the right

the region. and China portfolio with and in So collaboration we're Japan to elsewhere jump free in feel and in the go well. specifics really any the with lands. to performance BeiGene And And on pleased the address about continues there Murdo,

Murdo Gordon

part BeiGene, Prolia, listed as Amgen-affiliate elements in that business of executed them we've our with That's both projects the enjoy KYPROLIS, well. I Repatha BX, business our on. China And we has products essentially Bob the on and national BLINCYTO and growing rapidly, to both is nicely. And list reimbursement obviously, exceeded extremely about think, and doing growing The performing drug China. well that our Both are partnered closely formerly team continue to across continue The Yes. products in it. we well, described. And with expectations partnership, XGEVA. work R&D other on

that. pleased So overall, with

Operator

Our will Bansal Mohit last from Wells from Fargo. come question

Mohit Bansal

of the that. mostly regarding it assuming I'm in a of of more you coming? back-half would loaded, about and thinking a but get should the I biosimilar franchise, we cadence how is any love denosumab just color mostly have about a are how to the sense question think erosion biosimilars

Robert Bradway

Sure. Murdo, that address moment? for to a want

Murdo Gordon

timing of biosimilars bit the on we've given enter clearer Yes. settlements of have will reached. when the a Thanks, Well, understanding a we Mohit.

used the in I in the we've more osteoporosis. agree with by erosion just back be, different cadence the that fact encourage of got X in Prolia erosion towards I the going remember that biosimilar would the of general. to and of used here situations XGEVA definition postmenopausal would the slightly So to timing, biosimilar the everybody end. slope largely setting And oncology is

to slopes our It participation there in good So lessons us we how the are successfully on a the position biosimilar overall, the defend could be innovator different. But market. side. teaches on given in

on a fairly team have the that now. large Prolia we many of And calling our bone account for and so And we been XGEVA years accounts executives have market are leader.

so we they that there's incumbency the think other defend biosimilar to competition that we a positions us enter market. as And have certain well against

Robert Bradway

Okay. and call. Well, after the Thank interest, We thank thank you up to quarter. forward catching for you look the you you. for all your next joining

Operator

full our year concludes QX earnings XXXX This call. and

You may disconnect now

Amgen (AMGN) 4 Feb 252024 Q4 Earnings call transcript