AMGN - Earnings call transcript Q4 2020

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Operator

My name is Erica and I will be your conference facilitator today for Amgen’s Fourth Quarter 2020 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker’s prepared remarks. [Operator Instruction] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

begin. now may you Sood,

Arvind Sood

despite Okay. Thank call financial Welcome our were strong afternoon, for are pipeline two themes Erica. review our Good that execution, the to say, year I everybody. pandemic QX and XXXX. advancement to pervasive. would you, the and results full

Slides the stick to So, one Erica as question We'll efficient been overall of of call to have and the duration get hour. let’s it. limited format one rule, pointed an after prepared or posted. out, comments

Just reminder in we would non-GAAP our use presentation, statements forward-looking. a the that quick financial and measures some be of

SEC materially. could that cause identify different to results Our filings our factors actual

that, our with call would CEO, the turn over Chairman So, to like Bob I to and Bradway. Bob?

Bob Bradway

and the them, thank want outside And staying XX,XXX this around to in all all I’ll Despite grew sales focused product done. a we for our markets. thank our Otezla, say most believe has of pipeline, delivering expanding major, and both XX% By performance for in we you, XXXX our that breakthrough from We perspective provide disruption of runway Amgen’s China safety discussing billion, the XXXX. world. long-term U.S. leadership successful transactions all a Arvind, start decades-long year plus did than products. to have by goals for well growth by tezepelumab, global a XXXX, employees our while of inflammation very of by innovative on call. our Japan, us. and our health in job growth. our of further integrated which billion in the then delivered driven any earnings, the was you of on some and joining you our on to for today I priorities presence Thank successful COVID-XX, designation both advanced $X the successfully received We sotorasib We of We strengthening $X volume with and notably for therapy more and sales FDA. the strong

to As XXXX, look we embracing three we're realities.

leading in how lasting is we COVID-XX do to First, business. changes some

expect For and continue effectiveness. the capabilities, improved around clinical with world customers call run efficiency, trials on speed, we example, digital to leveraging

we on prices the Second, industry. across expect pressure ongoing drug

We like are penetration have fortunate can meet grow of products increased and the Prolia, Repatha, of to of that populations. patient Aimovig the patients needs appropriate through millions

future. Our industry-leading portfolio for of is biosimilars well-positioned also

We’ve showed Avastin we here track is inhibitor; it first our competition PCSKX We've inhibitor Third KRAS first the just built doing We've approval And with Herceptin, is of a filed after flow Repatha, also the our right we're it into paramount. time dosed a for MVASI capital KANJINTI, continues U.S. inhibitor. record entered medicines with and patient. biosimilars of GXXC and to the XX biosimilars, We to first with approved like months now speed in quality sotorasib, the sector. featuring the first be and approved to approved execution CGRP intense first innovative where speed. first-in-class Aimovig, like that and shown

year as to expect inhibitor. tezepelumab in the We again TSLP do the it later when first

a I year promising areas to time We building where areas want These moment of in when since investment speak for of research about strategy. and R&D will address central capabilities. increasing in to are I'd about But to Dave of investments, a some we is the on couple excited this pipeline plan XXXX. our differentiated our moment our on focus pipeline our like mid-stage a are are early our long-term candidates.

data information. million our whom subjects approximately UK, U.S. we we excess have genotypic of phenotypic capabilities, on individuals. are X we already genetics, database million will to in have or extensive where will the augment X.X and and human industry-leading First, the we in from have adding the This

the different design. of the our There's trial we're levels proteomic use pioneering efforts well. benefit new is selection as to measure large-scale the work universe the X,XXX some principle days it we protein flag to an interest of where multi-specific molecules the and just field, targets but activity drug that, to of and of We as addition, have in of believe relative looking emerge this generate industry the through the and degradation. to blood. in to time than in induced limited expect other use clinical insights in we broader We're biologic the industry at leader. through degrading area this call area early proximity. not genomic degrading opportunity I expand we proteins. It's targeted We're proteins to We're platform are growing our druggable to in proteomics idea is as molecules from a an to designing the In excited still targets. about dramatically wanted want The

water Reese, of forward to able little and our look and provide our STEM turn place agenda ambitious environment, respect to now, to a and the in of summary, and less, I With patients not programs. world-class we're advancing time funding committed more XXXX, our ourselves great me willing ability on taking the All providing we've a your and neutrality In ready, at later world our questions ESG more in with success in The it. to XX% XX% in reduction beyond. carbon medicines the Amgen a low-income R&D. reduction work over education than confidence Right is innovation, companies at XXXX along proven use includes deliver of me by is in gives achieving to before. expected is to needs Head when that call. waste. XXXX an ever in to cost no Dave let

Dave Reese

Bob. afternoon, sotorasib, inhibitor. XXX I'll treated KRAS Thanks, continents. today with more everyone. been than patients first-in-class Good five To-date, GXXC our begin have across

non-small data we lines few therapy. line earlier Conference for on GXXC cell ago, World reported patients indications into plus Lung Cancer, KRAS XXX new on the lung and inhibitor A at pivotal accelerating this cancer. of days are where with we We first the groundbreaking program second presented

deep, range of remissions, rapid, In the survival months. complete across analysis, with intent-to-treat Sotorasib poor duration profiles mutational and drove objective adjudicated XX%, in subgroups was rate response a including X.X months durable a XX three centrally was prognoses. progression-free response responses was broad of and

two, demonstrated a the anticipated States coming submitted the recently, sotorasib X Australia monotherapy in do cancer with And Importantly, on UK, More to data, cohorts weeks profile. continues based United launch files advance versus in December. X the and and completed in this differentiated first study regulatory EU from we months, Canada, in global very study tolerable submissions these lung in clinical submissions of Brazil, colorectal and as we non-small The and nicely preparations are docetaxel expected half additional year. XX the Phase combination with our these cell Phase beginning latter data well-advanced. and

We first investigate will study patients monotherapy X tumor most initiate likely second to a in on line Phase where based lung we benefit, cell non-small will in the cancer sotorasib quarter, in profiling.

tumors those harboring mutations. example, For STKXX

partner, as the Academy NAVIGATOR the study the February. look AAAAI, completed Allergy MEK study Virtual cohort. in inflammation, the Finally, safety X forward at expansion our in Asthma to of of the at have presenting Phase at American results enrollment dose full also Immunology Annual and with the sotorasib hurdle from In end known AstraZeneca, an Meeting, inhibitor our and along combination we recently we cleared

a with abstract may in for data primary utility counts provide You tezepelumab with and results patients broad severe of potential we have uncontrolled seen eosinophil a view, breakthrough low including key designation United where rationale States. from those endpoints in yesterday, therapy in have the of with posting the the secondary asthma, our the that compelling population

we filing to half. and submit on in the our We which with are expect working packages, closely AstraZeneca U.S. EU first

cancer; and our two XXX XXX, progress targeting are to currently to coming about we PSMA, AMG dose particularly are targeting and AMG we lung AMG expansion for prostate-specific in DLLX Turning expect is advance or excited dose months. expansion, into small antigen, AMG the in XXX cancer. for cell platform, XXX, solid castrate-resistant the membrane with tumor BiTE making prostate we rapid programs,

continues are the oncology continue to in portfolio. our profiles release, as we press will seeing quite benefits positive these results, Aimovig Aimovig colleagues over in our topiramate as migraine molecules. at we both And, clinical X We actively prioritize Novartis superior patients are demonstrate also migraine, Phase announced of our for the safety setting. of In prevention pleased with to and you with see important showing efficacy

study staff patients. for and ABP of to Murdo? SOLIRIS. their portfolio our portfolio X Finally, I'd XXX, enrollment our deliver we in our ongoing continues biosimilar our In have efforts like our biosimilars to for thank Phase closing, to completed advance,

Murdo Gordon

at with is in Starting despite with from Dave. and we've integrated portfolio rates annualizing finally, our driven year-over-year XX% since full Thanks, grew by And billion year-over-year, increased Prolia in the portfolio, roughly Repatha year-over-year, $X.X our pandemic. year the Otezla, XX% XX% volume product growth, significant acquisition, in XXXX growth first In growth. EVENITY sales. total U.S. by driven year-over-year. now And biosimilars over growing revenues internationally. by grew sales volume seamlessly volume strong $X sales XX% prescriptions innovative totaled growth. impacts the billion with equal year-over-year, X%

performance. lower XXXX. EVENITY remains a by in leader. its to By Prolia's patient remained our growth unique reached In profile growth. In pre-COVID patients. treating of price. entering $XXX We patient volume effect positive drive quarter QX. bone repeat fracture by year-end, to In U.S. QX of Product on disruption were profile post PCSKX as building continuity. echo COVID our EVENITY's levels, physicians high-risk leading for diagnoses Net believe sales year-over-year, fourth sales than ensuring net historical million, osteoporosis continue franchise will stable quarter-over-quarter. the to we global growth new trends, X% benefit of volume sales patient XX% grew XX% were in result Moving in driven franchise, in Repatha a trend and the cardiovascular, focused approximately driven risk numbers QX, sequential as grew bone appreciate their starts,

for position we U.S. in growth the enter international markets, price this from expect and stable formulary relatively improved driven momentum we XXXX, As net globally, by brand U.S. continued PBM

the Aimovig, market patient leader XX% Moving is starts. volumes highly quarter-over-quarter new grew class, impacted the as on in in competitive year-over-year the negatively pandemic the quarter, to remained which fourth flat but CGRP

inventory in X% decline the end-stage in change. QX to to to XXXX renal to January of forms approximately customers bundle, their Parsabiv. as Next With treatment as advance centers accommodate inclusion the expect XX% others dialysis protocols quarter-over-quarter reimbursement some generic while in built of cinacalcet. we by Parsabiv’s in U.S. decreased disease sales utilization, sales update the XX% declined U.S.

sales of half XXXX. in second as be $XX of million of the in expect lowest build also deplete the QX the customers year to We inventory

future U.S. in the in the the Parsabiv We moderate increase offers gradual is and and on rheumatology control delivery segment, maintains opportunities X% in lowers Otezla launches, to which loss, driven our we see declined patients secondary patient For reduce the burden. quarter lab sales over attribute Parsabiv were to Also, coming calcimimetic Volumes that providers Enbrel, attractive through share to global hemodialysis, a part in opportunity $XXX calcimimetic pill mild XX% in portfolio, coupled pandemic. IV-administered year-over-year the fourth psoriasis declined with prescriptions. values. sales the by planned U.S. to submission With year-over-year. million in from key inflammation growth total hyperthyroidism and Transitioning for QX, the our indication growth weeks. only slower

net Enbrel trends the safety enhance For to we price was invest in which growth, efficacy, biosimilars. declined to we an solutions QX innovative partially million, offset low and established has were price. the digits, in XXXX, continue single record in by XXXX. selling of driven to by and and Switching patient $XXX experience. net will declines volume net volume expect persist to in price and sales

with biosimilar and the XX% are and RIABNI, recently biosimilar U.S. launched QX. our XX% average for KANJINTI, MVASI to We a We share and leading in a biosimilar, in in AMGEVITA Europe Rituxan. fifth share for respective in

net sites average with volume For XXXX, to the of Neulasta decline published In GCSF their in other XX% of for Neulasta the continues to GCSF share increased treatment administration. in be Onpro volume the or for innovation, recent preferred remains and quarter. due without net oncology, most to demonstrate we expect selling biosimilar to to declined And in competition. selling a year-over-year. receive of prices partially Onpro return decreased price. Overall, by allowing Neulasta offset patients volume value growth by price the XX% their declines the sales having to year-over-year, U.S. selling in care driven XX% doctor's office long-acting

persist forward, the Going increases. volume we biosimilar competition and trends expect price to as

national received of for growth about multiple opportunities we planning biosimilar Internationally, excited business. which China. we're our launch In Looking XXXX. we're of ahead, in accelerate for our the drug the Japan, listing and Aimovig, reimbursement launch will preparing recently Prolia, across across we're new markets for brands in

the to sotorasib the XXXX. with million the to ready with therapy X.X world prospect our therapy and launch patients more is people the team foundational serving preparing for approval, about can upon with I'm our our launch AstraZeneca, to for cancer. of asthma. look a uncontrolled living as help QX it are performance, lung Finally, and advanced year forward in patients enthusiastic pleased of full also partner, severe excited and having a with and treat tezepelumab that we're Overall, in And establish Amgen we're

Now, to I'll it turn over Peter.

Peter Griffith

evening, good and everyone. afternoon Good Murdo. you, Thank

the for revenue growth. X% In our pleased full and with execution QX, year-over-year EPS fourth XXXX. X% delivered year are performance We non-GAAP in and and the we quarter strong

full growth. the XX% delivered year, X% EPS we revenue and For year-over-year non-GAAP

both year for billion, and around full respectively. for the Free portfolio $X.X from operating X% in grew drive tezepelumab. year XX%, respectively. X% As sales full innovative flow and the quarter expense sotorasib advance much fourth Operating our growth and of accelerated volume launches, the year of of full the for the for our benefited growth the including as billion year, expenses. prepare future fourth XX% QX pipeline, mentioned, $X.X globe spend and to expenses full and for cash Murdo Otezla-related particularly was activities and year-over-year a and increased Non-GAAP volume-driven quarter

launching for XX. look page We business XXXX in products. in in investing Now, on the for innovation to and forward outlook new turning XXXX to

of in We will upon some contingent with speed throughout our volume-driven and anticipate to strategy. revenue growth later XXXX, year, also on continue to the variability earnings effectiveness we vaccination. the recovery potential and COVID, execute also and Due quarter-to-quarter uncertainty global in

and GAAP earnings share guidance is per per our revenue is share. per per $XX.XX to billion, earnings to share billion guidance $XX.X non-GAAP Our XXXX guidance $XX to $XX.X is share per share. $XX $XX.XX

Now, let guidance. in our me embedded mention several assumptions key

in globally Prolia, accelerating First, time, At Repatha, We from continued our innovative Otezla and competition and in our net EVENITY, our importantly, sales, as revenue ESA the Parsabiv decline filgrastim range portfolio. franchises, reflects Aimovig, same growth we selling XXXX. experienced and against biosimilars as Murdo as portfolio, highlighted. X% erosion volume expect in oncology our U.S. prices well a

first expenses recall couple year, again when A For of Aimovig. XXXX. expect lowest represents XXXX, Enbrel, the declines. we mid-single-digit changes, products, U.S. deductibles, quarter especially price sales reverifications considering QX Otezla of and higher including of points product the Historically, patients work co-pay insurance to as through quarter for the with planned and

from roughly estimated Additionally, to due remind sales entire I $XXX and XXXX, Enbrel deductions, inventory of approximately in in million to that saw benefited portfolio QX favorable changes $XXX everyone COVID. the want to build

to was XXXX. be of So, XX% our QX QX as lower the XXXX than percentage expect it proportion sales, a a full in year we slightly

$X.X the agreement manufacturing XXXX. shipping be from revenues to revenue for in billion we in second year other This which quarter. billion range antibody COVID-XX $X.X includes under share expect We and to Lilly, the expect begin profit to the full of with approximately

We expect launches products operating at similar X% invest efforts. XXXX XXXX continue as grow and expense in operating to to non-GAAP to new innovation, growth, a expenses total digitization rate non-GAAP of we the

a operating an product margin royalties of a share structure will in We to sales payments. to expect and and have of XXXX. XX% to evolving mix, and profit sales industry-leading range an increase due an percent cost higher of XX% XX% Cost of created as product roughly

with connection Additionally, cost our in with of manufacturing sales Lilly. will agreement increase

including and increase increases expenses year-over-year be pipeline investments. in will on late-stage will our revenue. focus other with And and our efforts. profit changes Research early revenues the to included advances development in previously, model share as increased and mentioned I due SG&A decline, in will As digital primarily an commercial

January were expenses results historically me let adjustments XXXX, take our investments. have are adjustments XXXX income to equity the equity quarter XXXX policy. Effective These other moment been investments non-GAAP is and longer recorded results our in an forma press to This a to and explain will making Now, include in our fair our we positive no non-GAAP update will value our strategic included in and release to accounted results. for in contains method of equity the policy. non-GAAP not under our investment which under updated The results accounting. BeiGene, apply non-GAAP is change pro to by

our XXXX income the this We policy incorporation for thus and updated Under quarters expense. we which connection use quarter billion will for our now recorded in also of to Recall going three BeiGene's actual purposes XXXX, one here expense This policy for use conform the additional four I BeiGene's results. other quarters experience available and that $X.X anticipate billion with of only non-GAAP amounts that of limited may range income estimates guidance depending versus variability expense. to lag. $X.X a publicly just in on forward. in XXXX reflects is guidance adjusted non-GAAP explained, guidance We our on that other results are consensus comparison of updated BeiGene

basis today in current is $X.X U.S. this of price. approximately XX, upon investment was billion and as valued long-term BeiGene Our XXXX, market December the billion, based at $X approximately

to in allocation manufacturing $XXX shareholders capital year, the by capital expenditures, growth sustainability capital form we Our analytics innovation our and scale then expect remain investing our and remains external XX% hierarchy in to expenditures our including approximately also strategy first efforts returning and to capital quarter Board's of rate to the integrate of the $X in that committed to authorization. environmental our and to XX%, operations $X.XX support to data in we continue both is of finally, million non-GAAP guidance well and of billion, global everything and internal in digitization increase tax additional our to we enable $X to And an XXXX will to subject other including the XXXX this share Amgen. as share. as volume-driven We per range carbon neutrality initiatives our anticipate achieve opportunistic in at After growing and XX% dividends, in capacity repurchases do billion investments unchanged. up

economic are deliver confident concludes success public in challenging in greatest the the disruption for every time, in we patient summary, will greatest Bob. update. our and turn for and over we depression. years, a So, investors since every And year beyond. included to the XXXX that XXX crisis for health financial call I the the now great and This in in Amgen's outlook the back patients

Bob Bradway

Okay. Thank process our you, the And to Peter. begin our let's invite you for remind of let Q&A, Erica, callers session. question and me

Operator

Your queue Young Instructions] Cantor [Operator Alethia with from is first in question Fitzgerald.

Alethia Young

Phase different KRAS Hey, this, these guys. Congrats lot know my little and about you but of like I from about, obviously, just questions. guidance X as of program maybe a the different asked glean kind about what on great could get taking and guys to of of I probably with but combinations? unpacking -- just Thanks talk think closer, how and and studies, Thanks. a kind indications? solid early some for the you you're if a it looking getting wanted know kind that quarter. you I maybe closer perhaps we're combinations, bit is

Bob Bradway

XX%, data. beyond then combinations. increment a lung to depend I quite is you're XX% Yes, therapy the looking colorectal that. cell beyond and a there's will bit at totality indications this no and of of of It's cancer care, indication, Hi, any cancer, other the do on of Alethia, Typically, going line the get about also say What endpoint here. on XX%, generic standard given and one thanks we looking non-small the the answer of for for question. but course, some

in many progression-free of particular, ultimately, settings, think in survival I and these overall survival.

profile we'll look safety we've a date, demonstrated the sort given those the are take efficacy metrics that at. to So, of probably

Operator

from Your next with question Yee Jefferies. is Michael

Michael Yee

And a before mentioned well. cohort, going expansion potentially just get guess, at so of it's actually MEK combo lot data? well? to point talk do enrollment. I I you've actually SHIPX well. questions, Can it? would then, you I'm really And as exciting year? The on going whether completed It's data be you know, combo you're the thought KRAS I That to a thing bet you Could you that able comment at about David, be as conference be have the announce was maybe done that to want that on you could report pivotal. whole ask pivotal, make as I the on this out some piecemeal to

Bob Bradway

Thanks, we the are pleased with Mike. in enrollment very safety cohort. Yes. of MEK rapidity No,

to have data depend we'll again, beyond we expansion this the the we pivotal on as year. And It's could of this from As be to we've speculate those moved results. quite in it's data or will just and the cohort. It noted, that that on over too not. possible early course whether as see come

line which pretty I've these make the As sort regulatory on of decisions trial. mentioned, a blown would And regarding context. that and are derived in course, is data be master any given up intent indication from into of protocol any we that so therapy, can rigorous arm Phase essentially designed, of depending X

what So, more quite come but seeing data of unfold, as with happy enrollment. we're those terms in to we're

Michael Yee

And SHIPX?

Bob Bradway

it's moving SHIPX, On along.

come the that year combination. on more is that I a of And over to interesting again, potentially course biologically, as the well. think very combination

Operator

Terence is from question with Sachs. next Flynn Your Goldman

Terence Flynn

from And you the just biosimilar franchise, sustainability I Peter. out know, puts margins maybe me. a margin, any frequently. you for a some XX% And visibility was of and we the level, into I just think for of Bob. higher wondering question get then, there? two-part again, your about Maybe that that's look and how then, takes? as Maybe a the operating

internally, platform you an that do is on expect time for all externally you look where or a area Do is lot you out. an the of also degradation guys forward spending opportunities? building protein that that You are could mentioned interesting to

Peter Griffith

margin. you. Thank Great operating question the on

make at continue you intend firm, also to top-performing go biopharma know don't flexible out external As long-term financial metrics attractive sure as you to on do we importantly, a operating But, that any want be margin. and I to look arise. adaptable and on confirm, when we opportunities remain that. of that you mention and investment I we will basis a number internal know, and/or

the and cash volumes our underlying flow. have after objective We to tax grow

to So, that's us. really important

We are permanent on committed lean to our productivity commitment.

digitization in automation. we're I As working and on investing and mentioned,

to we'll to muscle margin. all do that and that biopharma operating exercise an make sure continue So, outperforming we remain firm

On a the question. that's biosimilars, fair

We see competitive. of as there. able we to to think Murdo, to margins And now, we've played do I strong strong lot on for says And have execution be that. us. quality in in as an who got continue And and to biosimilars we're biosimilars. allocation extremely defense very some high level. of capital we're like confident continue expertise to we've we're very that quote a continue capital The of category, to a terms we'll offense, of allocating that

So, in to it think, questions Bob. good that, and over flip -- I'll I to

Bob Bradway

question. Terence, the thanks for

intention as just calling remarks, it it protein I can degradation, grade be said, proteins as well. our my induced there, we building platform. we're describing not used, that The in as than that but be other clear molecules think to rather I targeted technology the to proximity As we're said just is

for term. And in of we This spent jump this will new purpose two and -- of build and capabilities. Dave, evolution and thoughts. other, ago now as look, research again, remind So, as both set strategy. this I I I'd the area, years long internal would trying internally with to the how feel acquired is position Dave, of for that helping your his lot a we're about think remarks, we'll said, excited be I said, out each And team to in long-term about add externally. in it. to my time external. free continue to imagine you and I to both And

Dave Reese

Yes.

long undruggable. future. say I multi-specificity Bob. part both be the very the as covers pretty making as currently to those is I to view it going this would this Many external important of to combination and think targets for expect that targets technology are investing of innovation. desirable that we haul, currently drugs we of we XX% tractable. and a Bob that many a that and the in you know are well, be mentioned, of And XX% We of think internal

Operator

Harrison is with Stanley. Our Matthew next question from Morgan

Matthew Harrison

issues Dave, comment I and a confidence And safety I extended that have it your especially half-life to bit in program more programs? little was wondering as if you just of on could just those what's some BiTE relate of some happened? the, guess, seems programs, these the to

Dave Reese

Thank overall, bullish Yes. I Thanks, BiTE on question. the Matt. very program. you would for feel say, I this

acute XXX we advancing residual extended because is program of AMG myelogenous our our investigating is release the AMG are quite And XXX these we're that these according to making entire fulfill Cytokine we a and development. the confident half-life disease, first course, we'll of with purpose setting BiTE shape quite leukemia. choices in As on can well technology I'm making before such come AMG prudent that. the to investments syndrome say, shaping portfolio And mentioned, whether in molecule. that up with rapidly. field. molecules minimal of where we in This can really medical in that forward. clearly anticipated part generation closing we we done Many few close choices molecule, We for investigators. part as our strategy. challenge I'm were I a that quite clinically going single suited. of done important sits was optimistic in handle adjustments about profile the the XXX for of a the our need. an that as positives There which would are We're the unmet BCMA many are of XXX selected platform, -- concert

feel and that how good I platform are So, we is evolving. overall, about quite where

Operator

is Your with next from Yaron Werber question Cowen.

Yaron Werber

refractory sotorasib, question give Erbitux? given robust then, on a steroid that a have otherwise. other surprising. follow-up. for similar or sure tezepelumab, it's encouraging if response late-breaker get if combo, looks On you is us MEK was the design you don't differences And biologics, And Obviously, the can with ones? and the that dose from Any really design to sense? KEYTRUDA, you data of study able I you're just trial the good. comments a more David, SHIPX the on a potentially the you, it’s trial sotorasib. full consider mind, repeating to how in I’m not quick The Would other the

Dave Reese

This we're Yes. are depending how on I oncology either moving. is regards actively out very emerge. different scheduling, drug about are expect escalation, those quickly looking as in tezepelumab, In strong. is competitive. the Thanks feel feel agents. some ones guidance to mentioned abstract And cases, questions. as you doses feel combinations, the the now. We at the we'll Xb dose good we you development. in the data or to We for With standard all the even mentioned, data provide we're Phase

in ways, the population, With in and high the the eosinophil steroid-sparing best eosinophil study. in population low many standalone the

of As with that a were spring. anticipate we data we're our designed little through you speed, out would be on with moving whether and think And we the are all current was that would with tezepelumab, deliberate study with point our this presenting issues. partners, follow-on later filing, discussing alluded, that going not potentially trial announced And data. we a we're appropriate. global design as differently submissions there trial I necessary ahead investigators, based those for

Operator

Geoff is next question America. of Bank from Your Meacham with

Geoff Meacham

demand a you speak look factored headwinds tezepelumab And contribution, guidance, you level, any COVID have can assume in are there this, looking year? missed XXXX sotorasib do any, may I to if still higher you assume at from a year? or XXXX more for but product sales, at curve normalized Peter, what you this as all revenue when and

Peter Griffith

moment COVID in to and XXXX Geoff, just continued jump here And invite for I the mentioned. of the Thanks revenue recovery Murdo rollout, on and a soto teze. in in impact look, expect potential we throughout the year and latter I'll vaccination on part contingent question, as the

Murdo. and of very So, soto to you we've as look, getting me we'll lot that be And a And invested with turn let imagine. forth. the and closely preparing teze, And that, for a exciting time so money monitoring to launches us. respect those over can for it's

So, Murdo?

Murdo Gordon

Geoff. we're complement in and affect number Obviously, about they've just time this question, submissions moved frame. to quite very the fast his and developing of sotorasib. product Dave been regulatory a team Thanks, in I excited the how Peter, and thanks And also they've want compressed able for to

review that a markets and the we in around fairly we'll hopeful So, quick get optimistic world. multiple are

so, high lung We we unmet but contribute sotorasib of guidance, to very non-small these There's advanced choice expect would product-specific to medical revenue. of And population large don't this is a give cancer cell lot not for a patients. need.

at one cell and a put I'll be to in caution that the their do Right high percentage that we file be GXXC lung The potential status KRAS their So, with out there'll that cancer a actual that ascertain record. medical advanced there. XX%. need of non-small about have just result anticipate now, is market patients we a

got work to seen, an that you mutation, number. And when other the rate have rapidly. So, we've obviously, therapies, actionable we've fairly do to rises testing grow targeted with

have we meaningful nonetheless, authorities given we'll But to we contribution breakdown with be can at able So, we that. to obviously, We the now significant in least guys on market will was pan-eosinophilic a to -- part fairly very expect that through upon think, we about an see is had last I programs think hope The us COVID COVID the abstract. to the will that for do majority a will just that get we've be that the impact do then medicine in the question year. beyond improve. think will that breakthrough now, in and designation. the the the you regulatory hope the important And of vaccination this But in think filing, you fact, the given be of to of COVID U.S. the and year, seen, results XXXX. what see sotorasib wrong actually obviously, we're better asked teze, with right And market, Geoff, I revenue midpoint I quickly. would we anticipate the approval

Operator

is Seigerman question Credit Suisse. from next Your Evan with

Evan Seigerman

one development ask allocation and capital to want on I priorities. business So,

attractive this need your repurchases, scale So, beyond flows quarter. assets, pipeline more reported bringing opportunity? do it leverage an you think seems was in in about lever levels, mid-stage like free up pauses cash to of there's assets? With noting if going dividends current And would XX% growing you how a for there several larger and

Bob Bradway

in think, that I in been the saying we've Evan, is on business. pretty consistent our focus investing

we're in prepared remarks, this said our our R&D as in So, planning increase to investment year. we

allocate to therapeutically. areas committing the opportunities very expertise what in continue We'll we that's And where externally. to look They're the likely development. demonstrated opportunities, have We'll and small focus we that capital to with very well areas internally sit demonstrated our in. continue larger opportunities. R&D and that So, have to entail expertise look at like licensing active business

rather the that as balance arise. have flexibility. they we hypothetical, And maintain of than sheet, terms engage a strong sheet individual we'll so opportunities balance consider in In strategic we

Operator

is James. question Dane Raymond from next with Your Leone

Dane Leone

outlook for Congratulations XXXX. on and update the

the question externally and sotorasib that this heavily to, a also vertical this first about a tumor vein, oncology. what's assets a coming of on would it it a building in for could was How or out but Amgen. In Obviously, asthma that little you've it in more or bit invested bit tezepelumab, to focuses make specifically, area the thinking thinking be little year. touch vertical bit around on maybe space, historically, the been of same in solid been internally previously. point half but different it commercial case, expected tezepelumab, more going but about hasn't Allergy So, is behind other been for forward. than that new indications in you are me, that you an vertical approval a launch discussed broader obviously, that

that. and/or program that be might assets on program Are more around presence there, the differentiated do the resting you You're we you space? something other that your about outside BiTE thinking should BiTE could behind the might externally highlight that there internally kind expand tumor of solid

Bob Bradway

is out respiratory which There AstraZeneca was our We just very that deliver by respiratory that entered had you. the we there, could particular, me felt just what for as Dan, you shareholders point double an quickly, out, Murdo for demonstrated is a you medicine. more group opportunity, and with into new patients in us. collaborating I in around a a in and with expertise team lot let we when area will more we that a pointed But, partnership remind question. your for

in with that partner collaboration And And and others molecule Murdo, came hopefully on capitalize also and share to to the so, that on them. we've But commitment solid to program have to with chose we taking and to I biology AstraZeneca, market through look that time. in able with anti-inflammation jump decades forward particular, tumor your in been over and the would to we're we with of and information of experience this pleased this the just thoughts out our point question.

Murdo Gordon

sure. Bob. Thanks, Yes,

are tezepelumab We And we commercialize Amgen teams as region. Americas speak. the out help in building our will

So, beyond play the U.S. while AstraZeneca focused will allergists, just specialties. respiratory be we allergists, including Canada, broader on and will a role

this So, a is that you area, in done, mentioned, it's disease but different as we've it's from what -- mentioned, inflammatory new Bob as not other processes.

broad experience extensive a payers. that's The in access government again, for programs our of patients. leading we'll And in secure taking range other help Part tezepelumab access the worth broad contracting for thing establishing be with will biologics us and role a D mentioning tezepelumab for is

of a eosinophilic nice building is their benefit you of status. we the for As customer-facing here same out product And profile Dave team that will lot have a capabilities medical obviously regardless Reese's patients saw, then, group.

they're on relatively very The It's So, allergists productive they're effort. size. we're focused beauty of a small audience focusing excited about it. prescribers, a is but

kind our So, oncology one to When business, overall we've patients we'll therapy. strong oncology tumor an supportive today in therapeutics looking and how we got that. now we're very have it comes oncology addressing now at solid that our quite five be in base our focused Basically receives hematology Amgen portfolio a portfolio, right of biosimilar our between our on care.

bringing sotorasib that have, the the and and to and Dave I'm we're can for excited asking team then earlier strength a lot turn clinic. other deliver comments. additional I think, Dave potential into into we and that. of I'll more, always to next of on we XXX, in know a it is build AMG assets that few I XXX current action-packed XXX And years his over fairly mix put and that so, oncology have about to Reese the

Dave Reese

gastric of some solid of going indications. a solid preclinical. to couple a We're that late will the molecules also clinic got cancer ready And we're BiTEs, just indication. We've More speak about on other entering tumor in target we've Exactly. as along. got course, them tumor those,

a quite broad I So, think portfolio. it's to going be

Operator

Robyn is Truist next question with from Your Karnauskas Securities.

Robyn Karnauskas

oncology a we decline looking the really can model a biosimilars? tail the of MVASI you differences MVASI Thank think just some decline versus Putting the should was together, And between of there's you. have that. for what the trends of how drugs if give just like us I Murdo. and is and you I all the model and how the think KANJINTI help us of price Neulasta, your was So, impressive that Neulasta help sense of decline, strength just about at significant. question now for strength to these think

Bob Bradway

And biosimilar revenue of some in relatively growth recent we biosimilar from the international our AVSOLA the of our as Robyn. at will Thanks for question, additional launches two portfolio. the come and look from And U.S. would that obviously, majority XXXX, I say additional launches RIABNI,

bit are twofold. molecule as think little a whereas you to to actually molecule KANJINTI, Specifically, differences they ballistic than There's a about that if flat MVASI Bevacizumab are two the declining. trastuzumab more the major is growing, a and as is And different. ones.

MVASI we're that of thing is cycles growing. one So, seeing overall bevacizumab actually number of is the in

And so, holds in even share quite that holding up actually molecule well.

competition. have also the factor. That's We less other

now trastuzumab, more less in bevacizumab So with we have molecule, for competition competitors. the whereas there's

differently. those a think brands competitive bit I shaping little forward, two going so, you would And see dynamics

Operator

with Citigroup. Your next from Bansal question is Mohit

Mohit Bansal

historically. Congrats has well. been this like the It U.S., been have EVENITY. market on globally as product, on progress. all And able seems one grow difficult question to Maybe you not a just this

please growth any the of the you anabolics do or from Difficulty] existing the you taking expanding of in market? when whether us help share expect could challenge this terms characterize So, And are you're product. market [Technical comes to then, you

Bob Bradway

Yes. I was a little bit up static. picking of

on So, EVENITY. I think the question's

obviously patients, new first anabolic part. business. from didn't -- question we've Japan our part got evolution but existing market we're we EVENITY EVENITY question, let Overall, I a or we been it's evolved. has bit the growth? with was it the treating of our second in We've Is how address patients? are expanding Japan, The first me the sourcing pleased and little the I how nice part In the in understood longer. are catch of

that we're thing one duration XX-month are a patients for So, on product seeing treatment. EVENITY with of the is

those replenish patients. so, have new And to you

have source patients. new do You to those

lot new was sourcing and And was from unfortunately, there a suffer so, EVENITY got osteoporosis And need in their a I of now patients markets and unchecked switching Japan high-risk like necessarily improve our at think not -- solid from where which growth clinical goes the fractures aging is and we these patients anabolics. these other patients be builder, are in are outcomes. quite patients there able early to to experienced team where bone

of more Whereas in de I the we're now we So, in Japan, of think XX X were novo de and perhaps growth sourcing mix switch. U.S., than ago. to more it's months novo much a

a and lot other a in despite their really The have A will the Prolia and of come the us is, for customer. time a Prolia course, patient having good they're candidate in EVENITY. thing fracture for that's both when treatment, EVENITY of the helping U.S.

So, we're getting often treatments. on patients both

Prolia. to And on back sometimes treatment are after the roll XX months of EVENITY up, they'll

for So, a a to franchise an customers. and and have our agent both anti-resort it's nice bone-building have

patients. Europe are But, growth So, excited at I our high-risk EVENITY Obviously, very what reimbursement for become bone think, they good. about quite just very getting building partners for in UCB the these looks I'm post-fracture going product. as future for establish the could

Operator

next ISI. Raffat Evercore Your Umer from question is with

Umer Raffat

for the U.S. Murdo, rather population as for irony, at sounded least mentioned that target XX,XXX And you recently KRAS.

this And so much. this curious, around B, GXXC worldwide? was -- that and whether you for were for prevalence for doing math? rate whether or a So, U.S.-only assuming XX% I are if Thank A, analysis was only you you

Murdo Gordon

U.S. cell Umer. the estimate question, cancer for Thanks XXX,XXX at was XX,XXX non-small patients. the We The globally a lung actually number. incidents

lose Now, from in because unfortunately, patients in cancer frontline. second-line lung to obviously, reduction we there's first-line some

KRAS in lung and obviously our we at of target patient cancer incidence population assume population. The And second XX% beyond the cell a line GXXC launch. is non-small broad

Umer Raffat

Right.

I confused, So just Murdo, if down just was track, XXXK. XXK? we that the XX% go at

Murdo Gordon

Yes.

for incidence beyond. cell a of line that's number So into that cancer progressed have and non-small second lung U.S.-only

Operator

Your from MacKay Kennen is with question Markets. Capital next RBC

Kennen MacKay

spoke the I love Maybe always asking but question. maybe previously, to you for that it's BiTEs this Dave,

Within are the you next be X going stage early stage X pipeline, the Thank excited about in most you. sotorasib? what or What's to Phase XXXX?

Dave Reese

generate patients. than thanks. looking the are sooner to time That's early at. think expansion data XXX, that registration to XXX a ones highlighted think question. recently paths Again, continue we rather And potential I in a discussing for would larger Yes, if that and And has really we're cohort. advanced number as be into of we through of later. my as the have probably program we prepared I we that in I remarks, are AMG able terms rejoin just in pipeline, AMG XXX

as keeping think, in, move indicated, just then, X behind. I ones another a indications, previously interested as variety very we've our forward. we assets programs And is I'm portfolio, in that's XXX in eye of one that one Phase autoimmune on. we AMG we're close are quite inflammation that those got and step a And

Operator

question next from Leerink. is with Porges Your SVB Geoffrey

Geoffrey Porges

about question a Murdo, model. your commercial

you in reductions field approach. magnitude have You that headcount expect efficiency on social And Can mentioned of in distancing? there the couple you're significant a sales ramp think of And in that about up us give could organizations. back of to you Wouldn't sense have to heard how were digital prepared force moving of out what a world? once I'm might a more that your you play you by seeing just a commercial to post-COVID towards remarks times the in average shifting talk we you eliminate wondering, we've digital? been the your

Murdo Gordon

field in development. depending for which older question. side about you're on into the There and from that with portfolio Amgen, in the evolution One different our very were creating for the the reallocating factors Thanks, launches region Geoffrey, went product of we're portfolio. talking And world the of then stages reorganization just our capacity and recent couple is new of force. a of

paying and are price us being for investments growth potential Russia emerging bit net at force in markets market the COVID. the wind field of opening So, other and for in negative and/or effects mentioned in close And price here. example, a his Bob to forces as even China, attention that looking important we're the reform, as We're as in being beyond a remarks, Japan prevailing drivers. in placing we're U.S. in really in large some

model, more at making more your And so, overall our it we're efficient. making point, looking it what doing and to productive commercial is and

on year digital extent build we're able We move we out with So, greater plan. to an very our last had track than were largely and capabilities historically. that rapidly to even

will haven’t field compromised willing And customers ability that in to the side, in quite think those that What our frankly. beyond have done is we're we side, facing be persistent front both on competitive And voice on of to seeing customer. the engagements engage of we in persistency share interactions, those are commercial of the We COVID, betting medical channels. on. some both it's the

with compete digital augment communication. And be of effectively that in, so, to well as as the we think we'll to able highly efficient categories channels we're continue in

Operator

Our next Gould with from Barclays. question is Carter

Carter Gould

U.S. I of seems growth what given Murdo the guess, level U.S. I have guess, And the the the just us I growth timeframe, acquisition, Congrats seem mid-XXXX really, that back the execution. up it guess, at I have through global of comments to on come today majority going time your and the from in you? I the data, of teeing your Otezla impressive Bob, the be competition growth around to the the to oriented guess, coming forward. sotorasib confidence and nature the would Otezla, guess, of

Bob Bradway

you Carter, Maybe I'll we several we it, or we double-digit achieve just however can we launch first in take elaborate years the want on for markets. But, as to augment Murdo, opportunity, sense that. in of to maybe I'd But, confident both, that's as could feel the mild ownership, the is opportunity opportunity? the the range and we severe through to well potential to label say moderate, continue And when that and you'd felt like. U.S. growth international what function you first acquired Murdo, then a in two, increased said the of

Murdo Gordon

Japan. of do in pursuing we the Yes. registration We're Bob. We've recently see Australia. in now. in expansion We maturing good Thanks, business China, and Otezla a international reimbursement secured got for some

of So, we're beyond efforts where the Celgene evolving had footprint legacy Otezla it. global the

not area of also done we're of source inconvenient really the primary an that We're into to So, And they growth. as positive population by a a Bob one patient is data product have there basis These had historically. on of think include that an moderate messy approval in that mild the expanding pursuing are who Otezla set the something treat agents. skin might there. also in is us role will have the surface Celgene mentioned, U.S. and important helping very But, need. unmet that enough move care patients alternative seeking to to in to we still allow Otezla making patients. topical those I promotional in be promotion, that Otezla the investments play can footprint And

indication for we're but is, the would only in given established being for other category the rheumatology, moderate efficacy psoriasis it's well, profile both that it to the as perhaps well due and I little category the And COVID, of anticipation an is think is highly potential equation held of other strong oral the than of with safety that in that for approval. risk-benefit So, different where seeing orals broader Otezla also bit thing doing of severe quite execution very where been mild say in strong. that recent and has softness to we patient, a to the while rheumatology moderate are news and is Otezla up that appreciated, Otezla. has I broader

think for we opportunity we've a So, growth. got good

assumed successful We from guidance the a also confirmed course, And gave was competitive said that asset. TYKX when today. it we of that that program

Operator

question next Oppenheimer. with from Your is Jay Olson

Jay Olson

regulatory sotorasib and the could designation Since could on comment large you. you that submit all approval? lung for KRAS the on sotorasib their commercial percent in China, fast question? what And is patients filing is how Asian Congrats cell for taking thank you received and you gain a Thank mutation, you have for in progress therapy China? GXXC breakthrough Hi. non-small and how opportunity of cancer

Bob Bradway

to Yes. China. Jay. Thanks, breakthrough very therapy pleased get We're designation in

that our it than colleagues might guidance we'll China one bit move potentially provide plans the the time we're lower forward There mutations. in in has with like. United filing in looking with about because a States. they what But, in our look is may at which populations, then, is high a populations, are implications China quite quite Asian lines at it XX% As And little thing of GXXC mutations Japan, little does those that suggestion probably BeiGene, in different are for prevalence these carefully a mutually to epidemiology it in be exclusive example. and up EGFR, in

research that don't China. will that commercial We've important I now, the if about anything at we that. side want So And Murdo, question be collaborations in got you know address. looking just to an add active

Murdo Gordon

Yes.

We're and product, oral specialty need. what very it excited sotorasib fact an we can obviously very medical China an for about that market with makes think, unmet is accessible. do the the is I attractive seeing products we're huge that

sotorasib excited we'll affiliate is that. our commercialization about very in So, of pursue China, and

Operator

from Colin next UBS. Bristow is Your with question

Colin Bristow

is Obviously, getting a fact of significance? broad keep seeing level label group you've tezepelumab, I with previously? for the impressive. FDA that something in your than And that I'll it was light statistical looks it just the less the you short. test discussed what of curious in Is confidence for abstract didn't the pretty data XXX

Bob Bradway

of frequently. regardless Colin. we a We a count. range get in Yes. broad question is This across patients demonstrated efficacy eosinophil of Thanks, --

clinicians as We'll I to. proceed. think regulatory guidance will pay attention that's provide what discussions

would it's important is And look medicine a But, just patients like. for be differentiated strong to with asthma. these potential think, of very, I product. debate severe too that early, pointing a data what this are uncontrolled going to course, think view our is prior a to very really to overall label I submitting

Operator

is Gal next with from Bernstein. question Your Ronny

Ronny Gal

biosimilars. Just about

exit bit be little anticipation just there competition increased in it? Are making to head rate? get talking price my the XXXX market, and or spiked would in decline about is XXX%. the You any coming reason decrease issue that that to going the hard XX%, payers the a XX% Is will of pressure. cite this expect an oncology changes, to in it's you Is

Bob Bradway

definitely think I you of a of rate Ronny, see or Yes. in diminishing share. return volume terms gain

in for U.S. oncology the the of our uptake see shape that both biosimilars You our in curves

as those add the still way be to But gains contracts volume incremental mentioned I And are set to then, course, the There's network I on those some think contract of scripted both products now, in most in And are tend incremental. oncology of used And setting, the in motion. remarks, these trastuzumab setting. the basis. that continue my about largely to will way, base. XX% think yes, used, bevacizumab evolve price our businesses by on will revenue overall trends, a I the to community of opportunity seen a they're community by of and network we've usage in them.

Operator

Guggenheim Securities. is Michael question from next Schmidt with Your

Michael Schmidt

could hear insight was your little if that some lines, about that and genetics translate platform. efforts induced R&D the I thought made Thanks been within around stage may proximity new to human was you interesting or this comments into early so provide bit Along it initiative, I into progress much. made a the wondering have of were more when how may those initiative pipeline and products? the

Murdo Gordon

really in transcriptomics include our such there's largest programs long term, to proteomics completion. technologies we focus Bob on that there's and that on million because have think the primary and or such we Intermountain Biobank that data them At higher simply In X will collaborations as that, percentage as of for these secondary. either which majority time, database validation of genetic our up mentioned as we'll previously that development. evidence for clear success. that's human Health data human Michael. it belief will And the other broadened projects earth have move in announced, genetics, have to Thanks, portfolio genetic have towards and we that as participants. a most rate be And assets have expect increase with support and targets a omic will add human UK Yes. the drug on as the current We important are over and discovery based now time we these non-oncology

But human and the we come. in that is Thanks. to we the that firmly industry. era collection we of more of believe intend So, upon unique data our us, believe push to almost capabilities forward. is And

Operator

Mizuho question Salim with is Syed next from Securities. Your

Salim Syed

strategically, solid one tumors has has interpretation? to the correct high from Kyprolis me about has And guys. with it that's is the say Amgen do gone if that just Just if in significantly that, gone down and When here, correct a interest the significantly interpretation here, you up? anything level interest think in curious hemonc to

Murdo Gordon

I invite is, it think but don't I to... Dave Salim,

Dave Reese

Yes.

shaped Kyprolis, nothing to data, Salim, think, course. that do evolution be you're of of emerging What has So, expect on emerging will yes. forward, portfolio based going based seeing we a the with that. to natural is on I and data,

it's the we of anticipated making. a today management had strategic that announced choices choices. our we up portfolio we And prudent to that think changes make teed we those some And

our to IV decision, move to call And out have through program. collaboration MCL-X precisely of we're more that and with control we among we exposures window, anticipated achieve given after formulation. and the the choose ability me molecules. we dose with would we made in in where forward those reinitiation had that escalation Again, Let elected our investigators, particular, moving therapeutic a programs

So, no specific shaping conscious choices, to based on more versus emerges. data tumors as hematology and solid come

Peter Griffith

of able I a jump those would to it. full of do job strong our the specialists be and And we to fourth and approval in data in say, expect quarter given in around a nice aware first hemonc promoting quarter Salim, the combination had CANDOR making the just quarter, daratumumab. we of on Kyprolis world with

story more So, now. come a to it's growth and good Kyprolis, on

Operator

Your Research. from question is final Tim with Wolfe Anderson

Unidentified Analyst

on for question. my Galler Andrew is [ph] Tim. for taking Thanks This

sotorasib in Europe. about thinking Just

on single arm able in higher Given has describe for EMA DOR? for approved this typically to response a confidence XX-month degree be threshold get approval you'll XX% can studies, of your rate you

Bob Bradway

sure. Yes,

discussions. need We discussion do will probabilities we've focus on Let got at that don't We'll unmet to the obviously, in patients think, me provide and EU, therapy, of regulators We I guidance fair filed going is that world speculate But, or in it recognize approvals. regulatory time. the the forward. with mutations likely that the question. medical ongoing first-line terms timelines of appropriate take after say around GXXC large the certainly in be

Arvind Sood

minutes questions. fact apologies you. of XX to over to we tonight, for get thank that Well, want the Again, but about did your we all went

after first being together we forward with your thank quarter. look you for your the And of or seeing Company. you. of you support you Thank to interest the the So, end and back

Operator

and Ladies conference results XXXX call. gentlemen, Amgen's quarter concludes this financial fourth

may You disconnect. now

Amgen (AMGN) 3 Feb 212020 Q4 Earnings call transcript