- Earnings call transcript Q3 2022

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Operator

My name is Jason, and I will be your conference facilitator today for Amgen's Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

Sood, you may now begin.

Arvind Sood

Okay. Jason. you, Thank and everybody, our call. QX Good welcome afternoon, to

Leading execution quarter growth our with So innovative our we focus Chairman the our with pipeline. our Bradway. advancing volume continued and a CEO, will during on products and discussion Bob the today key be for driving

your some describe use customary non-GAAP measures and to reminder forward-looking that We have reference some and posted we'll performance. statements our slides for my be making financial

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

Bob Bradway

moment. increased quarter, prevailing X% earlier in results quarter non-GAAP all net in in Amgen Okay. joining demand X% price up patients products communicated with we call. on you, generated underlying challenging that for Thank and XX% of X% macroeconomic the our reflect of economic for what for quarter with the the decline In a those our times healthy you, medicines of both consistent focus These they a impact earnings at All the even our of $X.X foreign down Revenues and the sales reflecting the cash delivering in volumes per the from XX patients the bring was to record and Benefit the and flows free remains face strong outside shareholders. third and quarter. value industry-specific exchange. told, evident XX% challenges, share like reaching X%, States. the a United for were with year for and laser-focused billion

drivers. growth on forward, Looking focused we remain several

as experience the products, in new our inflammation innovative we're XX many and to launched that this medicine excited and more portfolio. recently is TEZSPIRE of globally we're can and patients, product With to benefit decades treatment solid ChemoCentryx for underway nephrology combination performing recent the innovation. the to underway, TAVNEOS forward. exploring have to acquisition, Two other TEZSPIRE of have patients vasculitis off our studies several are With ways TAVNEOS performing LUMAKRAS importance starts. leverage for of payers recognizing we product patients than we this asthma, different confident in well well LUMAKRAS, many may we're more the years, this and well. bring ANCA-associated that moving is in the in through prescribers for time. and first is closing studies with indications

and launched products to the from industry-leading in biosimilar a to in market. company U.S. five to business, HUMIRA more a months most HUMIRA the of that an not biosimilar let's benefit lose number than Prolia And generated key quarter these fact EVENITY growth volume $X in products today. products biosimilars first having us can Repatha, the do prescribed have We've we're We giving being is the with of sight as we prepare markets patients sales away we enter led built X millions U.S. in and of know by Otezla, the XX%. confidence AMGEVITA Europe, world, globally that now the around they third billion collectively launch already

Looking of of three with for are molecules. SOLIRIS to our having forward, our these EYLEA STELARA, successfully trials all Phase next biosimilars and wave III completed well now positioned

serious hear innovative many diseases Amgen, and are and molecules pipeline, tarlatamab, and which medicines treatments. Reese Dave others suffering vintage shortly five from We a through need first-in-class remains several is make medicines big that potential difference advancing have bemarituzumab for better about AMG These for for our there which new you'll XXX. real including rocatinlimab, patients from new a Olpasiran, that

Griffith. as their to turn them, that, CFO, I to let our engaged thank highly great over a work. committed Finally, me and and want we Peter workforce, With always, for have

Peter Griffith

on are pleased We're Bob. importantly we against our to serving track patients. quarter, execution and objectives, you, Thank deliver with long-term most our this

a best-in-class for Our TAVNEOS, acquisition launched product to ChemoCentryx our first-in-class a innovative treatment portfolio, adds patients approved newly with recently of and closed ANCA-associated vasculitis.

walk total X% XXXX In financial of The financial decline Slide through billion. the are QX, shown of slide on our deck. before results guidance. we X represents modest revenue results Let's discussing third our This a quarter recognized $X.X year-over-year. of

rights KKC million our the Non-GAAP to will Recall generated of XX% QX expense both per QX portfolio and grew upfront million revenue KKC. decreased highlight operating AMG Kirin flows million to R&D year-over-year excluding from the included expenses strong would continues XXXX. $XXX and product X% those currency, innovation. fund recorded external Excluding sales the grew the internal $X.XX revenues respectively. in recast X% license of for results in product driven $XXX that rocatinlimab, impact total grew sales in Other XXX, our foreign to and payment to you, with XXXX. our million expense Corporation, product payment Earnings $XXX related almost established to review Non-GAAP of deliver year-over-year. increased by license. EPS Kyowa $XXX KKC X%, cash versus and Murdo primarily X% but product share million to X%, sales $XXX I

as basis, shipments. product a offset mix, COVID-XX to by product on costs On due basis cost advance impact XX.X% in the to total pipeline while product manufacturing percentage product increased our sales. non-GAAP supporting as launches. year-over-year research delivered sales lower a reflecting a X% a of third upfront with we year-over-year, sales the costs operating lower margin investments operating $XXX X.X of Excluding quarter increased partially a million fewer also changes primarily capabilities antibody points of XX.X% of and non-GAAP payment, expenses And to and percentage associated percent

offset year-over-year support. X% million in primarily quarter and spend the the Excluding payment, partially due lower R&D pipeline spend, and by expenses third marketed $XXX year-over-year. XX% SG&A support increased upfront higher product to Non-GAAP program late-stage increased early non-GAAP research

driven was interest expense about digitalization. $XXX key our of by the equity OI&E because and was We million focus share Non-GAAP productivity, continue third the accounting. to net our investments in on driving BeiGene automation in results increased method while expense of and of prioritizing quarter. This of use activities and

from lower extent due anticipated liability that future to expect gains do not than was the we in OI&E Our quarters. same to management

third, investing We have a generates in the execute balance and opportunities best acquisition significant business patients; on significant Ohio following: executed ASR business our flexibility share accelerated and growing and XXXX; share dividends, multiple cash QX through year-to-date. construction capital quarter, $X.XX external execute The fourth, development third retain quarter, investing sheet, final to to program, Carolina; capital billion our settlement priorities. expenditures, the on and the our in and first, in quarter, including for shareholders of this our environmentally a have per returning strategic at we in new is on occurred flow ChemoCentryx capital the recent example financial repurchases. clear we XX% facilities shares second, advancing through friendly third in a repurchased about the opportunistic the including from strong repurchase, innovation, allocation share of of increase in North case, representing $X.X In

Turning through third for to the the We're execution with pleased our XXXX. the quarter. business outlook for

million quarter. the FX year, headwinds against rates, billion net XXXX absorb our we For dynamics, FX And $XXX $XX.X we're through quarter. about despite billion. sales recent million third the of absorbed reflecting foreign in hedging nearly the our $XX.X on And product of updating based range to this challenging is strong now which we $XXX expect activities, our to to exchange revenue guidance execution third through full

of $X.XX with We to or costs headwinds FX the for associated our $XX.XX range based of FX year approximately encompasses X% are non-GAAP these both additional to on recent closing and focus QX. trends EPS of our updating are range This likely remainder ChemoCentryx to $XX.XX. points full rates impact consider and year-end. acquisition how incurred XXXX I'll share for a between to on the a particular with few

government million Nplate. We The has about to sales product to $XXX expect million. FX headwinds in $XXX QX by agreed of purchase reduce U.S.

We about recognize remainder $XXX of with the those will in sales in QX XXXX. million

billion We of Sales annualized previously November longer billion. our billion $X.X to sales year business expect business, of other the and approximately continue results, operating no billion divestiture full our to operating reflect XXXX recast to non-GAAP $X.X decrease prior will full we of that in expect XXXX. $X.X for expenses against year guidance Turkey XXXX X, revenue We comparing expenses to year-over-year. product a from at between double-digit now our million. generics effective When that recognize and have $X.X business $XX completed Gensenta, versus discussed low

We of to continue as to a margin expect roughly XXXX non-GAAP be XX%. product percentage operating sales

upfront non-GAAP cost payment sales expect to decrease XX.X% non-GAAP our in recast of as the X% a include of in R&D R&D above. to We continue which now $XXX product of X% range to the million to XXXX XXXX sales. expenses expect percentage expenses, to we compared non-GAAP discussed year-over-year We XX.X%

as product non-GAAP expect flat sales. be We to of roughly spend year-over-year percentage SG&A a

fourth expect to in OI&E with of the range and be quarter billion We to results results. $X.X billion quarter closer the second $X.X first to

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

be favor currently high will macro recognized the rates U.S. goods to modeling in XXXX. roughly replaced Puerto our XXXX of has excise reducing tax the without that recall Note, the inflation, charged slightly executed in to PRET income interest a goods inventory much that increase larger headwinds, the June XX-K. previously Summing Reduction benefit changes negative for changed your tax, of since review benefit. of consider up, Rico impact the you an Act. Form Inflation equivalent well PRET, be of sold dollar, business Despite in with cost XXXX, February, law which than there that persistently As was strengthening is tax XXXX cost charge in at amount by onetime by residual passing tax income in the of these the expense implementation capitalized the of our discussed the with the higher an will related while enacted level tax of in the the we XXXX This XXXX of the XXXX, and have however, Rico a PRET will of in corresponding sold. in amount Puerto

expect for that call on these and As we our operating continue. years, QX guidance plans our XXXX successfully earnings we we to headwinds We're expect anticipate provide to January. will against plan Like XXXX, in execute previous them. adapting

of over millions long-term This on work my the behalf our turn XX,XXX I it those patients confidence update. Amgen colleagues strong. their every for concludes growth I'll in the thank mission-driven patients Murdo. for and Our of financial to courage their remains day. of

Murdo Gordon

volume BLINCYTO; and Nplate products, additional several We and products, AMGEVITA, Repatha Peter. double-digit delivered KYPROLIS, third Vectibix, TEZSPIRE, including including with quarterly strong sales EVENITY, saw Thanks, growth We year-on-year. an for and record growth quarter X% increase the for volume in XX LUMAKRAS.

sales which which our sales increasing Repatha volume were year-over-year year-over-year increases offset quarter in offset quarter U.S. driven sales declined Prolia volume generated X% XX% of of by was growth with net a third the price, driven growth. Prolia aided growth business, In Excluding by Repatha grew in XX% by U.S. partially volume X% estimates. exchange start Repatha cardiologists the impact, and revenue growth X% Overall selling growth, selling lower X% driven which providers. year-over-year. X% complements for price. the global portfolio $XXX broad as decline sales grew of by bone volume we prior with XX% of the consistent Aimovig. general XX% I'll in product foreign by foreign XX% EVENITY, by our Including U.S., bone and impact XX% XX% primary X% sales the our exchange, record EVENITY, In the and adoption volume product by negative our driven grew care includes Prolia, for portfolio, year-over-year growth. now million health, increased volume adoption this volume medicine outside by net had by

as to declining we and access. in rebates broad Part D support also selling prices saw Medicare We U.S. the commercial patient higher net offered

world. year-over-year volume XX% of ahead National Net Looking cause leading the morbidity addressing XX% U.S., China's growth. Overall, a on U.S. Repatha grew focused saw we in patients January on less driven to primarily List inclusion outside of need all erosion we XXXX, Reimbursement declines were Repatha's we XXXX. remain price in price to Drug of by sales U.S. Repatha mortality expect result X, the as by XXXX. the than around bringing and of Outside

the sales Otezla portfolio. year-over-year growth, saw unfavorable the lower remains by inflammation the and Otezla psoriasis of exchange share, broader U.S., X% volume mild-to-moderate bio-naive in our X% foreign offset to patient inventory In partially impact. Otezla increased psoriasis. Otezla Moving and see among we with quarter. patients for adoption leader

psoriasis asthma its range due for payer TEZSPIRE strong strong prescribed oral have with X.X phenotypic of of of adds broad our and first-in-class and Allergists to destruction eventual spectrum the uncontrolled its coverage growth permanent of without inflammation of market a TAVNEOS can continued nephrologists, TEZSPIRE, has biomarker acquisition treatment safety only recently of established that to differentiated where treated to initiation who or cases, potential and safety. TAVNEOS and uncontrolled often I'm expect and Otezla's treat U.S. systemic unique major also This in asthma. with of a Looking we patients any our the to with U.S. recently for million organ forward, for quarter are requiring given be vessels. quarter. volume estimated small represents broad unique and disease across biologic-naive severe and to life-threatening. presence is patients patients sales launch the pulmonologists significant sales TAVNEOS testing. million TEZSPIRE's track long autoimmune patients. a profile, more serious completed our inflammatory and to worldwide We a remains applying driven of and vasculitis, develop active managed disease. manage with product third can selling XX% severity the can ChemoCentryx, important seeing This net in decline or severe TAVNEOS. to launched successful profile broad patients We regardless is by both who damage We're as severe AAV patients and record treatment disease record. our portfolio. Physicians position disease systemic very track strong the acknowledge leads Amgen previously patients year-over-year a and, treat AAV. a lead expertise strong $XX the forward as that which generated inflammation blood which and severe advance ANCA-associated their lower in sales volume. of in help pleased look experience to with unfavorable ENBREL experience decreased ENBREL X,XXX X% deductions of rheumatologists in changes an price, third some XX,XXX to a a AAV for year many deep efficacy AAV. by relapses

Moving business. our to and hematology oncology

X X% with products volume Our XX% innovative growth. grew year-over-year

to quarter our in benefited Vectibix from in of For growth and Japan. Nplate, timing strong volume the partners shipments

growth. In the X,XXX approved the been by settings. countries. and markets. patients in has by Germany. the of unfavorable LUMAKRAS third revenues both Our sales declined community is price net launch selling with over of LUMAKRAS progressing We've in and resulting was XX% lower are volume well launched over to X,XXX our quarter. rapidly Quarter-over-quarter LUMAKRAS $XX U.S., Outside markets approval over to been $XX million the academic due now has in in driven prescribed reimbursement XX X% partially offset in from in This XX by U.S., a million price pursuing adjustment clinicians reimbursement remaining

before, Longer potential U.S. to is the earlier-line on we've ex patients LUMAKRAS come expect in other of to declined term, term, Sales near growth As LUMAKRAS focused second-line U.S. of X,XXX and from the oncology types. for treat setting. year-over-year. XX,XXX tumor our XX% noted biosimilars and therapy the the we LUMAKRAS market

early in the most for of I'm EYLEA selling recently growth XXXX, time, net leading year-over-year KANJINTI declines The be Over driven for driven price upcoming we new competition. in launches shares, by biosimilar both pleased U.S. preparing followed While for continued published and and in of to ourselves launch execution long-term selling in deterioration molecules Overall, the HUMIRA our by hold the U.S. next declined addition our increased MVASI SOLIRIS. MVASI AMGEVITA, We're XX% of we in biosimilar, to wave price and our our XX% the biosimilars and the accelerating the STELARA, biosimilars and by expect launches. business with additional for volume KANJINTI year-over-year. expect average very declined quarter.

position execution products of portfolio long-term over our I'll diverse on well and that, deliver to strategy. turn And to with growth Dave. presence international Our of us the it

David Reese

our from Thanks, start We're you're afternoon, colleagues I'd now good Amgen. everyone. excited welcoming ChemoCentryx. Murdo, of to part by new like and that

to was and execution general Association data a. on at a Beginning we Lp of in several the American interfering and weekend little study with coming RNA lipoprotein pipeline. For from one third continued plan Heart elevated present This innovative with data we quarter continued meeting, Phase research clinical the a presented little where programs progress to II of medicine. development, Olpasiran, our targeting a small molecule subjects new

the multiple-dose receptor, very Repatha between on gastric and achievement in single- or inhibits the cohorts Conference levels activates We at from additional Phase Repatha the of sustained GIPR, the and from lower cardiovascular of XXX, Hybrid to major and Diabetes will Cardiovascular extension of association Disease Resistance, Congress present the LDL and open-label AMG the also the plan significant events. multispecific FOURIER presented Insulin cholesterol that inhibitory highlighting of December. studies rates and a data polypeptide low study and Data receptor, World XXth and I GLP-X the be low

expression AMG the body XXX Olpasiran discussing with November take reminder, an to We is that for the and inhibition that X. at look a call to of lower unique lower approach scheduled on As decreased based human XXX we forward data of data mass index Repatha to AMG weight. suggest our an the along of chose Monday, GIPR genetic aspect on leads innovative GIPR, and investor update

from Phase in measures to in where plaque inflammation. moderate-to-severe in at XX presented In week SPROUT III improvement trial, XX. ages to of psoriasis placebo compared data Turning X resulted the significant we September, treatment to children's Otezla

September, In moderate-to-severe demonstrated life III and itch in with Phase Based Otezla on quality genital these for improvements psoriasis, disease. approved FDA DISCRETE was ongoing in trial, to Union of with XX.X survival. clinical of in notable XX%, to response response of data a from European and statistically tarlatamab, the rate globally other add molecule regulatory These tarlatamab the jurisdictions. authorities setting, are DISCRETE continue Japan, from SPROUT reviews XX-week and studying the durability and cell with presented data encouraging overall months. antitumor overall survival skin, significant discussion demonstrated of is cancer. U.S. a DLLX-targeting presented data we data median delivered also in of with response prescribing patients activity and small this information, including data a duration lung in median of In for a and oncology, discussions being the months confirmed XX results, patients BiTE We forthcoming. in regulatory where TEZSPIRE In

in SHIPX We a potentially LUMAKRAS encouraging from this cancer. first-line we We're setting. continue in a III studies. Vectibix, patients in continue PD-X both we In September, efficacy Phase cancer. XXX, inhibitor, checkpoint this lung or settings. on in in small with chemorefractory and combination. study with combination presented presented this inhibitor LUMAKRAS also where data to enroll using August, we to in in our Based standard Phase cell combination trial cancer with data to investigating combination and tarlatamab enroll and in cell with registrational care combination demonstrated neuroendocrine In lung in in data, with explore small combination on later colorectal prostate AMG LUMAKRAS continues patients patients II these metastatic of safety second-line cancer

objective line advanced a global to from where compared in non-small daily cancer. progression-free led with the received study versus were the LUMAKRAS with non-small milligrams confirmatory dose KRAS GXXC-mutated patients Patient-reported cancer dose significantly a III data docetaxel. We've trial, LUMAKRAS requirement LUMAKRAS mutated CodeBreaK XXX response outcomes from daily lung with data of and treatment XXX with increased cell rate improved lower post-marketing just higher comparing lung also with XXX-milligram presented GXXC also We in cell Phase a patients KRAS initial top docetaxel. of survival

discussions study Phase with from are XXX planning regulators, confirmatory data. this Following CodeBreaK submit we III to with data along

roughly expression. treatment expression potential or PD-LX segmented cell non-small intermediate study a non-small lung or by breaks We've non-small pass chemotherapy multiple are we into of promising PD-LX where lung to expressers, seen high planning population the first-line advanced first-line cell reminder, cancer. of lung investigating LUMAKRAS, down the across the in cancer a population in PD-LX-negative X/X PD-LX-negative metastatic early to with levels, cell data cancer As are expressers, low and III LUMAKRAS and Phase initiate plus potentially

primary a and primary of Finally, XXX, subjects efficacy biosimilar to to age-related an neovascular EYLEA, III met evaluating ABP the in analysis Phase EYLEA of I'm compared its pleased the announce degeneration. that safety investigational with macular point with study end

to SOLIRIS portfolio goal With from these XXXX. we announced Phase to with first-in-class III growth from positive we have to data programs stage portfolio back of conclusion, and now continue over and or growing important turn X Phase in III term. shareholders data data to of for and near delivering completed patients an it X/X candidates have new STELARA, clinical a well and biosimilars, our approximately for our potential our medicines the and previously biosimilar long deliver innovative biosimilars In of are positioned I'll Bob.

Bob Bradway

now open Okay. And Jason, Thank don't why we line you, up questions. for the David.

If you started. remind we can the callers of get procedure, our would

Operator

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

line now open. Your is

Salveen Richter

make you in existing a Good AMG to afternoon. question. of the XXX help move my how therapies taking in could obesity, the you'll forward evaluate just Thanks context understand data us for On differentiation given Or the of do you a to taking you're about think other Is market here? thinking decision a aspects and how piece it matter program? the there's just here size? of

Bob Bradway

that why don't question? take Dave, you

David Reese

and things I of Salveen. We we'll large, for our overall help forward are human rapid that this thinking in Obesity weight interest then we the loss; at this evaluating move is program. forward. dosing molecule is very disease. look this guide as of full the extensive will a know would the to We loss; the how sustainability. program December interval; as Thanks, be is showing weight what data week public lot that what dosing; It's of hybrid in a heterogeneous we first a shape finally, And on conference. data kinetics in capabilities health problem. plan development using mentioned, going there's the the our in And global The in tolerability. Yes. be do

Salveen Richter

Thank you.

Arvind Sood

the take next question. we'll Jason,

Operator

Matthew Harrison Morgan Our Stanley. with next comes question from

Your now open. line is

Matthew Harrison

Great. most Good or question through contracting of year. - been Thanks I to that the ask taking afternoon. been hopefully season now next question. wanted for the a you've through for

investor is one for obviously coming pricing think next concerns and what that to ENBREL HUMIRA with key biosimilar the year. year, next could impact have dynamics of I ENBREL

So and impact on I'm if the to its think ENBREL Thanks. comment wondering you just to can next how year? pricing about potential

Murdo Gordon

Thank you, Matthew. It's Murdo. We're obviously excited biosimilar about the opportunity HUMIRA. to to launch the first

And payers active PBMs so we are in discussions that. and for our with

to are in the We massive change and payers and got seeing change ENBREL pricing, access volume continue the not gains. on were if of PBMs a forward, and of a the would believe we for And to there for amount ENBREL's to it regard ENBREL. going safety be be good efficacy we've

As we're opening mentioned declining my about I remarks, in in X% volumes year-on-year.

finished it. Our contracting not we're quite maybe in even to upon goal that the maintain cycle. improve is But and

Arvind Sood

Okay.

please? Next question

Operator

question Umer next from Raffat Our comes Evercore. with

Your line is open. now

Umer Raffat

question. for taking I everybody two Thanks what on is have guys. a to talk Hi, which obesity. my wants part about, question

think within relative of us, if they players the you I And that your those single ascending. as triple any Phase program. moving from was one Manjaro, with six it the and I? year, is early you're efficacy about the Carsem, some high the and first et at imagine programs. I thresholds there the that. they the to most showed the And remember, question just certain they for speak agonist, business thresholds always current stage GLP you thinking two Lilly thresholds Novo, the of of space, ascending off I high-dose So sure talking Or programs was I'm the And three forward. too those the ascending you my programs on perhaps those you low about wasn't dose. that data thing could have of in the early-stage of beyond within I'm in of very average an out competitive the predefined Phase six and two cetera. to highest And single dose could first have different single there. meant if three lead quite emphasize And were curious is, cohorts? and are progression clarify your you of the the incremental products out low- for much. And X cohorts secondly, in cohorts the Thank I review both

David Reese

back broken question. of We'll the of a I'll going latter all data to that head, Yes. But set with the to of in you we're off Umer, that have -- on the month, is. the get top half you'll remember what out. full have my cohorts

I it very So point, think, at that will be clear.

In terms many ago, are potential a there I differentiation of thresholds, discussed short as to while avenues here.

agents number but for degree kinetics transition of also of Of of off what loss weight fair of one durability; them; these dosing course, is tolerability. a interval; the are; importantly, importantly, patients since tolerability,

as that it's we've are things we'll sorts taking of we look got a differentiated our the whether those worth scale investment. and a be So assess at product

Operator

Jefferies. Our Yee Michael next from with comes question

now open. line is Your

Michael Yee

follow-up the been examining we or we're expecting what fact be so that looking disclosed it's should be scrutinizing? you. just hear didn't with the started effects, I actual on Thank XXX. I here. you XXX I'm believe talk also you. not types status you you actually of that said not Phase actually going you GLP-X Can quarter, material, is another should or you for and the and ask this diabetes David, where the Thank about are that people II. to back dialed last potency,

David Reese

of and in started II relative design but trial believe we No, think of we're the point. talk near Yes. about we'll data and GLP-X in I expect II, had announced expected in initiating rather term. we the wouldn't Mike, don't that I Phase Phase sure once planning. over that And to course, gets launched, not We do give guidance on that's I'm terms component, the availability.

I you'll again, we in data get month, when at share a think, look the a that.

Michael Yee

Thank you.

Operator

Our next Olson Jay with question from comes Oppenheimer.

now line is open. Your

Jay Olson

quarter Hey, congrats deal. and closing the on ChemoCentryx the

think inclusion I the volume product said the Reimbursement the XX% evolve lot expect List. ex have volume with U.S. do mix you how talk And to and U.S. of quarter. Drug revenue Can outside outside about a the you time? in You National of China's U.S. launches and versus example, an ex third you U.S. on growth Repatha U.S. grew over pace as you. growth Thank

Bob Bradway

to Do jump yes, you - in. want

Murdo Gordon

Jay. Thanks,

bring Repatha over international Recall, example in our broadened for presence, market rapid Repatha. a to and is year national how think we're drug launches were to prior list. reimbursement fairly we're to a quickly. just products I with now market securing expansion What of is good the seeing the of China new able on new we

private it we awareness did Repatha. need stent for good to where were We deemed who think is real patient in markets understanding of promoting help percutaneous But patients amongst the demand there's patients, or unmet establish coronary I seeing intervention millions these the vascular coronary group. highest risk primarily of disease. to are be very pay patients education, of what you're So cash at was high

also continuing we're volume Europe. volume growth Japan we had And in so And good good U.S. in China. in obviously, our to had We build and out growth the business

that good the volume other to roughly we've just reimbursement markets, about to the we're in we're launch launches, about XX approval and in XX reimbursement we're pursuing future. seeing countries. is Repatha, given how example of the evolution the in markets, feel drive excited for LUMAKRAS other remaining So that respect will got we've roughly and that growth got revenue continue us the and in good product we With

patients oncology nice teams doing world a identifying KRAS -- have as and teams a of making job around the very they our LUMAKRAS that sure option. treatment GXXC second-line Our

the is level building is full growth. a high that and many pleased place, we've now at international been really for years volume functioning delivering strong I'm So in presence

have have where country every do Going partner we necessarily about launches global good have we're we where partners that. in responsibility forward, ability some products, feeling to don't wherever the launch products very our for globally. But we them to has rights and potential our Amgen and the

Bob Bradway

available forget, we add, let you we've don't in you the we U.S. with the me that data Jay, have And [ph] slides different shared products. - outside tefan for on all just the

business contribution international current there. the You'll the see from

Operator

with Meacham Geoffrey of from Our Bank next America. question comes

now Your is line open.

Unidentified Analyst

I have on is kind Hey, on EYLEA as for of this timing. as taking Charlie and Thanks the results. the well regarding potential just question Geoff. launch the congrats STELARA questions I for guess, the,

any Regeneron? timing And is launch wondering in you product you J&J? you second similarly next given to FDA, I kind the see and pushback of year EYLEA, anticipate I'm any launch whether pushback like for from you're already to think time kind the the that and if I guess of of frame the data half Thank from submitted XXXX mentioned were anticipate expecting STELARA kind you. of you

Murdo Gordon

and the for We're with data readouts the that have pleased question, filed. on Charlie. those some successful products Thanks obviously been

specific We timing expect be of to in those on those products. and wave biosimilar disclosing first we're launch not launches, the

Operator

Our next question with Capital. comes from Evan Seigerman BMO

is line now open. Your

Evan Seigerman

taking the you Thank so XXX to for question. going LUMAKRAS. much guys. I'm on Hi, not but rather ask about

dose? approved in lower So versus lead-in. doses And efficacy dose trial. you from you lower dose-reduction we think you Are talked the dose data had about I slides, the combination relative mentioned pembro a noticed trial, lower the expansion with characterize how the in dose? a the also that of the you combination treating Can with you had on should about

David Reese

Evan. regulatory comparison the Thanks, of dose in understand the top getting lot interest results Look, the there's data. to FDA line and Yes. a authorities. just We're we other

their the In regards to layering on and doing to dose it's checkpoint prior data trial, top to and appropriate checkpoint lower inhibitors, then with referring before, as lead-in, the premature So conversations. combination you're inhibitors. we're mentioned a believe the that dosing these review I to I've of share

concurrently going they are given forward. then So

Evan Seigerman

Thank Okay. you.

Operator

Our Mohit with Fargo. Wells question from Bansal comes next

Mohit Bansal

my Great. congrats taking questions result. Thanks for quarter the on and

year How have a have the seem XX%-plus the X have with that there? the lives Is seen you biosimilars biosimilars. about And couple like it that expected was the we decline it would your on we or think expectation how other -- pricing long-term in I over should Because doesn't certain in should it biosimilar. about a of an after regarding question So stabilize the after think point, dynamic years a we that portfolio? X but pricing probably launch?

Murdo Gordon

question, Thanks Mohit. the for

on think I commercial-insured because likely and they of works. slope medical see declines remember least to time of to side products which biosimilars over the way D benefit price so think products the calculation about retail will to U.S. you're what's bill in buy important continue when the at thinking in or price Products time. selling declines have their products, pharmacy pharmacy over are average side, the price or benefit Medicare in slower Part the net is

how Now both of competitors depend each many those on molecule. for conditions

products. a to a bit put the everyone class of little would frame different. time is I on hesitate So But

rapidly look is will the one thing One new In say to the on the fairly call decline going you long it's and are get business. think U.S., some heavy tender been in we of growth to each base can biosimilars launching come portfolio, markets. down where of continuing prices that's I need I larger, to molecules. markets continue hold what our our very then by there the clear we're as on competitors business, of of we've to a top Outside in market. will as pricing tends retail biosimilars and biosimilar in where at successive

Operator

comes with next Yaron Cowen. question from Our Werber

Yaron Werber

XXX there's couple got on that obviously to And and EYLEA, what it's formulation. a high-dose you potential different year fiscal dosing? versus comment in jives how it's milligrams a drug, same now an to to market impact first approved, secondly, XXX, that underlying XXX a just to I 'XX one for against the monthly the that be we going Can the does need launch? do antibody? just David, How can high-dose bring EYLEA, the you then assume X maybe. it's

David Reese

Yes.

-- receptor. bifunctional antibody there's it's first XXX. as agonizes the GIPR GLP-X. multispecific the meaning Let then that said, molecule, inhibits component a or a And on it's It's part component got I an me that take

expect sharing briefly the So all as me will On that. be let in that's interval. pharmacokinetics, But on antibody-like you Murdo drive dosing noted, we'll to ask and XXX, you can comment of a month. that what

Murdo Gordon

to with team that effectively development products of done compete Yes. complement competitive have biosimilar to that the think, our formulation talented Yaron, to I And thanks successfully, process very a and we've, in we organization. to full able be continue want their innovative products. parent

bring portfolio able across So we that the as concentrations be needed. to various feel we'll confident

So we're working on that one.

Operator

comes Securities. David SVB Risinger question with next from Our

now is line open. Your

David Risinger

thanks very much. Great,

for So my question is please. on XXXX, timing biosimilars

has an that estimated Amgen in FDA outstanding? in Regarding your when label? think in XXXX patent you planning January, in if succeeds, AMGEVITA, then biosimilar will at is STELARA to assuming do light of risk September litigation completion add study, launch interchangeability which remains interchangeability to And the

Murdo Gordon

take first. Thanks part Maybe second the for the Yes. again question.

biosimilar organization that we any manufacturing we're pleased data we're got and network that will We go. space to the the and And commercial we've ready our strong when but statements haven't STELARA, track that to strength made launch about hand, we'll in got we've closely. pleased Amgen of

be launches we new Feb be EYLEA wave with first next SOLIRIS, to an year expect is interchangeability in launches. early of new in one. of expect the wave the STELARA, and market We the The to in in stat the on AMGEVITA. And biosimilar interesting

I from we frame interchangeability lower over we and the HUMIRA relevant grow payers come into when with of to understand the other time But market. AMGEVITA, entrants to be But first think priority in may time, do importance. have PBMs. to being a that for biosimilar in expect it

Operator

with question from Next Robyn Truist. comes Karnauskas

Robyn Karnauskas

biosimilar follow the Just as second-line ENBREL with is of up We've third- ENBREL a that going the used often TNF. HUMIRA on you launch. comment ahead or heard to

price. of expect get to cases, a but - I that's motivations just really is HUMIRA that having that ENBREL many that why so have and flow-through you're it already curious HUMIRA And noted further there in pricing to was declines, on don't may you whether not when compete launches be part ENBREL -- you've

a help the me Just there. sort Maybe that's detailed -- understand of clear dynamics question.

Murdo Gordon

on don't dramatically to the we Yes. expect price didn't Robyn, expect ENBREL. declines thanks for next I we current be say into the said different that opportunity going I to don't year. declines clarify. continued price

we see patient to continue arthritis. rheumatoid on don't we in as expect a in range is that So used price category And dramatically. the ENBREL well changing do of competitive, of is as broad as quite slope but across psoriatic arthritis concede to ENBREL the types

frontline think and still, we what see we usage. usage a some I post-TNF lot do we is of see frontline see

TNF to to clinicians I going will efficacy ENBREL, many we So the is will profile in Not of every patient that respond and think options and the market. safety inhibitor, that despite biosimilar well-demonstrated continue. prefer continue think and

clarifies So question. that hopefully your

Operator

Bristow comes with next Our question from UBS. Colin

Your line is open. now

Colin Bristow

quarter. Hey, afternoon. on Congrats the good

one XXX, on I if So I'll take may. another

path this I sort assets aforementioned Is X be to us see all for in we from efficacy bar Novo of the the their to II that of that market. As we you Phase raised for and X the with years initiation could any lines here now the think to about time line, bar reason ahead at of does to mind it And any just that from around move is and this those Phase your there's took Lilly what of competitor there side? lips explore? could you, by that are time progression abbreviated think raise sort sort fact to

David Reese

disease globally now. major for itself, again, one of public it's obesity, problems right question. me the think the Obviously, let The Thanks health with, very disease. the start Yes. I which -- -- is heterogeneous a

of within of tucked that Our belief there is number obesity. diseases are the label a

Some diabetes; mechanical problems. patients have X primarily cardiovascular others, manifestations; others, type

understand our I this And to and we things Phase particular, the where take a at segment be we'll potentially data kinetics, further unfolds are noted, tolerability. so we populations capabilities of loss; be would look benefit things there we go and if field a we Those look as overall be and sustainability the that looking whether go using human as then you to for just see that determine in And molecule as can a not, forward particular will patients. to in differentiated and I or subsegments dosing; program in remind from these the we'll of pidity there. as then II have we again, determine data [ph] at of weight the

Operator

next Carter question Gould from Our comes Barclays. with

Your now line open. is

Carter Gould

taking question. Thanks the for Great.

commercially? also go out to able on a suffice it be but up you work question, that horse obesity alongside pursue like that is beat Or might and after follow important to dead to Sorry do the how diabetes here, indication? and you you an feel obesity could prior just

David Reese

But go a feel That's diabetes medication. that as question be essential Carter. a it we'll address Thanks, don't Yes. I we that forward. this it's

the obesity -- we most effect going we're and a As large guide diseases, of size. get I where said, is development to to we our powers number think this

Operator

Our next Schmidt comes with Michael question from Guggenheim.

Unidentified Analyst

This is Ted Michael. on for

We the updated data mean, you have How with can you think World to any you do be And develop over regimens Do different presented, and other you PD-X out have one combinations on far? [won] positioned LUMAKRAS combo prioritize conference of with updated SHIPX. view? different other? coming would I so each these data

David Reese

population. SHIPX SHIPX I applied levels. will No, guide That's II we then development. the enrolling our by combination, of of of And be enroll, layering inhibitor. inhibitor trials the expression in checkpoint that are those trial in on how then guidance of low-dose data we're followed Yes. first-line I'll LUMAKRAS think readouts. about in now those And And a will that mentioned, regardless PD-LX-positive have combination potentially a could determine run-in as of the combination Phase PD-LX terms population with terms combinations, data the provide when checkpoint the we as we exploring

looking at PD-LX-negative chemotherapy a again LUMAKRAS we're remind going the me population, everyone plus in to combination. let that Finally, be

Arvind Sood

see participant I the one queue. more Jason, in

one So closing some after will let's last question, Bob which make comments. take

Operator

question final Tim with Research. Wolfe is Anderson Our from

Tim Anderson

what are a you wanted be and think that's ask disease than two in I areas biosimilar to the just that like a uptake little X different to part market, question most. related U.S. will

in the a and to how ice is oncology? where such you'll biosimilar then in do compare already pace SOLIRIS your biosimilar with have you eye buy in where space, we areas know disease rare those as have and the the So bill. I think space will disease precedents, EYLEA,

I you but if those, compare is diseases think please. buy both, not could and rare

Murdo Gordon

for Thanks, Tim, the Yes. question.

our with in quality and who at least -- treatment. our slightly understand had for at biosimilars. medical of that our were we both behind the teams comfortable to the of mid-cycle on do buy-and-bill you before, treatment, switched by saw, individually mid-course there so that oncologists the on drive mentioned product them oncology to KANJINTI uptick. space, go fact to we generate biosimilars, MVASI beginning back and an what them was get access of I or assumption biosimilars or phase may the those they have that at maintenance circumstances the each the not we If patients of would calling As the their help And salespeople look products that to that in are and Amgen data out had the the

mid-course of we treatment switching to did so biosimilars. see our And

I I done the branded both. both uptake thought products. hesitancy think customer threshold both about some health and feel a subscriber for types, alternatives offering decent part of think the value create EYLEA on having And on of So in-market about to closely to opportunity with and research SOLIRIS our we And prescribers. those chances feel And system biosimilar the X care good by for our we good the was prescribers we've what we're we different. be would a that at looking

Bob Bradway

and me in of let by the joining all on or We let a strong end ending saying remain we few We Amgen. me at Monday that a again, weeks interest call. Well, and to just again to look then your 'XX here a positioning focused you with good And various in you Okay. beyond. thereafter, forward appreciate ourselves in thank year a for for short engage having few weeks short and conferences. our chance

we'll thank soon. you So and look seeing forward you to

Arvind Sood

everybody. Thanks,

Operator

QX our concludes XXXX This earnings call.

You disconnect. may now

Amgen (AMGN) 4 Nov 222022 Q3 Earnings call transcript