AMGN - Earnings call transcript Q1 2022

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Operator

My name is RJ, and I will be your conference facilitator today for Amgen's First Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background nose. There will be a question-and-answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

begin. now may you Sood,

Arvind Sood

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

I in deliver our while objectives. think performance staying on continued on execution focus track to against long-term QX our exemplifies our

let's we'll non-GAAP some that of So Quick statements will presentation in use started. been financial Slides posted. get be reminder our the measures and have forward-looking statements.

materially. factors that results or differ actual could to our identify cause filings SEC Our vary

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

Bob Bradway

attractive Okay. hello, for Thank in growth and the the volume currency COVID to The joining of in strong months continued that brands net the course, execution everyone, our the in opportunities, that told earnings number quarter two during growth. in In place price this innovative spoke should a on we'd selling February first of and and revenue of year, we We headwinds, that the generate opportunities achieved year, the we highlighted Arvind, of last growth EVENITY, despite effects declines. and which the these XX%; was volume many first you, as quarter, including and executed performance have quarter. Repatha, thank and Prolia, up up Otezla, that as be of focused in up also long-term of well call. our delivering attractive which generated on X% XX%; several XX%; well X% up share growth. XX% you When February, growth we you we enable us per deliver we first to oncology products,

compelling for cancer suffering off these products. TEZSPIRE, to from innovative non-small newest of asthma, a both new new And and for strong also respectively. severe and two lung we're Our pursuing indications offering patients start cell LUMAKRAS options treatment significant are medicines,

Let market, the line they're our we say, the expectations. with respect with on and that five well me to biosimilars have high-quality performing in just

biosimilar will time biosimilars AMGEVITA to long-term products launch of in to component in steady the is we next come growth end the HUMIRA introduction portfolio previously, strong the new region. the and the decade. our saw over noted of of new an for Pacific we've of our volume nearly products, AMGEVITA, by in growth of six that expect through January and of U.S. International As U.S. growth biosimilar Asia strategy, first including the important growth the the of a is XX% we launch XX% first year. quarter of volume outside the

Phase a our of potentially is data Since Turning biosimilars. to readouts to STELARA. biosimilar ABP review, continuing general our aware, number marketed innovative inflammation, you're we've for which had and late-stage business first-in-class our mid- opportunities in to oncology pipeline. and XXX, to and in We're brands Repatha candidate as advancing, while invest our LUMAKRAS, important medicine X

We more milestones come the have data the through several that year. remainder of

cycle longer continue expand an targets reduce times, look to the we our human in and set data generative we including Looking the the of discovery to to term, can we capabilities, of integrated research as significantly probability of and number biology, increase thoughtfully success. pursue, invest

development. sheet both innovation, to to and commitment continue business invest available, organically we're to our enable or is and efforts through us our to innovation pursuing to through strong it sourced whether As the comes best our innovation own balance in will cash in committed externally, flows and

Amgen health our history, throughout society, more care, that a and a in limit culture confronting when We're Our actions ensuring comes toward time as we equitable environmental four society areas: values. to with working barriers many reflect serve and access our have our at our part to address minimizing adjusted removing focus a patients these that challenges. doing work impact, is to

social environmental, and you're and If latest interested available was our governance more, published earlier is website. today report learning on in our

commitment me patients Before the let to Amgen just colleagues their for world turn around Peter, and my serving outstanding to thank I execution.

Now Peter, over to you.

Peter Griffith

you, discussing X quarter quarter drive XXXX we our on I Bob. The through our financial deck. long-term walk our the goal. We're first and execution as results will results shown our towards Thank growth pleased this financial are slide with before guidance. of Slide

The growth XX%. of first and year-over-year solid quarter revenue execution, EPS X% marked another with growth period of of non-GAAP

by Repatha, declines For and product X% driven was partially was growth growth selling headwinds. of volume and Volume foreign price Prolia exchange in by sales, strong net EVENITY. offset

comprised in to strong Sensipar sales deliver and Our of biosimilars, Parsabiv, product flows. $X of remains EPOGEN, adalimumab as United and Aranesp, NEUPOGEN, XXXX. will the And established AMGEVITA portfolio launch forward, we Transitioning in grow our prepare biosimilar this States most cash billion looking experience to to of continues and generated product January this in the almost leverage we prescribed Europe. successful

continue sales experienced product by discuss as MVASI year-over-year, revenues products. declines we for COVID-XX driven antibody this his collaboration. selling XX% For expect will we and anticipated, in $XXX detail KANJINTI, in remarks. to Murdo Other driven year-over-year and primarily price our of net these increased trend reductions more million by

costs, X% a as total we On $XX product in higher to quarter, our profit sales launches non-GAAP of cost due year-over-year XXXX Rodeo the acquisition and pipeline, year-over-year points percent product across First included basis, million and COVID-XX Therapeutics. X.X drive and non-GAAP in a a basis to decreased direct our execute of on that QX manufacturing quarter royalties Recall XX.X%, Company. increased the sales year-over-year. percentage costs manufacturing operating X% increased R&D as antibody to invest related digitalization Non-GAAP shares. primarily expenses increased spend of

Rodeo increased in year-over-year. expenses quarter first XXXX, X% million the non-GAAP Excluding the declined SG&A R&D Non-GAAP X% in year-over-year. $XX for

equity focus the and method of and continue as a driving driven our of were million by line to expenses interest This prioritizing productivity. item investments activities net of QX. share on expense and other and of in expense key income Non-GAAP BeiGene We our $XXX accounting. a result is use results

financial generates retain development business We flow strategic evaluate balance flexibility have sheet, a strong significant to excellent opportunities. and cash

to continue on capital our allocation priorities. execute We

our share investing and environmentally returning new fourth, dividends, quarter, first in included which innovation, XXXX; growing second, under through to external; accelerated the construction received repurchases, XX.X and First, per common facilities opportunistic the Ohio including capital share quarter, the third, stock shareholders QX XX% in under including million million shares business from initial North expenditures, friendly increase in the and in buyback including best our and $X.XX for through a internal representing and retired Carolina; shares investing in of stock agreement. capital XX.X

non-GAAP tracking $XX reaffirming with our for plan. XXXX to This may EPS date billion $XX.X range our a updated our of we're peers, XXXX that to our Turning with to the we $XX.X policy guidance XXXX. recently no and non-GAAP SEC. pleased issued to in Accordingly, revenue with to $XX. our not have certain for upfront does occur the guidance range from the growth of types exclude include Similar accordance from future. to We're by guidance such in business and EPS outlook non-GAAP our transactions we're results of expenses XXXX, billion longer the a expenses in to non-GAAP

two impact our to items non-GAAP For as that XXXX. the incorporate include expenses excluded is change in only now will that operating XXXX this were previously recast we reference,

XXXX. create on in designed is Corporation payment in to EPS XXXX: Important program research product and the product In headwinds mitigate an associated the in-process it income to acquired sales impact is recorded Kyowa-Kirin And from our had and related are of the our that reported in R&D of on of our includes guidance XXX acquisition note XXXX sales, been approximately recorded an billion hedging and We development X% and impact consider to our negative rates, program to $X.X Prime Five license hedging approximately upfront $XXX adverse in to AMG has foreign with points the in foreign million XXXX. partially foreign QX from second, or current impact QX guidance. to XXXX results expected total, additional exchange remainder First, our rights a approximately year. included the to net on sales, million while reported year-over-year QX exchange for our based non-GAAP our over of $X.XX. full exchange $XXX

range to to from were included our our revenues billion. the in COVID revenue $X.X QX QX revenue projected that XXXX and collaboration XXXX to year's recognized $X.X QX. We of full in to for expect billion continue other majority these a be across of recall

pandemic collaboration COVID the Our revenue outlook on state and the of continued support. depends government

Our expectations XXXX operating non-GAAP time the unchanged for spoke. we from total for last are expenses

expenses XXXX recast double-digit our non-GAAP a against year-over-year. decrease comparing results, total will now low operating when reflect However,

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

XX.X%. to of We as sales continue product XX.X% to a cost be to sales percent expect of

in R&D results, which now to R&D the XXXX million, of to response non-GAAP recast remain by X% for unchanged. guidance XXXX expectations our in R&D expense mentioned Our increased on decrease XXXX Based expected in a X% our SEC year-over-year. expenses non-GAAP XXXX non-GAAP expense $XXX equates above, to

$X.X of be reflecting and and income to full be year, as XX% our a non-GAAP guidance We is expenses tax sales. XX%. the SG&A of to anticipate expect continue change XX.X%, share spend other to our year-over-year a billion we percentage range previous billion, we range expect from of of our of for rates And results. flat $X.X $X.X up billion $X.X now to BeiGene's product in increasing to range interest XX.X% billion. of from rate This the And a prior to to

that XXXX proposed to the in petition the file an the Court the adjustments release. XXXX period for the We opportunity proposed to we U.S. the the several the XXXX to the IRS, repatriation to the to to the the dispute U.S. is earnings. expected audits. and deposits the the for Puerto certain many Company's wholly accrued period $X prior in take Amgen years, We've applied a methodology billion penalties to Amgen appropriately IRS by the is made XXXX overstates that could are that and reported across respect Company's adjustments have with dispute litigation $X.X billion positions XXXX XXXX Rico proposed for to overstated it that tax IRS believes income the IRS July period, transfer extensively transfer possible continue the IRS XXXX, consistent the for for proposed conclusion contest auditing any dispute for XXXX to the and the tax reform tax to period process. previously of methodology filed in IRS the due be the failure the upon update by rates of that up approximately that penalties further tax of cash a the is XXXX years $X.X XXXX IRS, additional believes, account years, would accounted of tax another previously the to to proposed IRS propose our the is to We've lessened Amgen of resulting of applicable expenses IRS would to for unwarranted. Amgen the contest the in and IRS this the billions in the audits the the XXXX the period XXXX Tax several XXXX and amount adjustments with currently magnitude may Court tax included resolve. -- reduce we period administrative the to will period the deposits by imposed. for period. approximately Tax merit. by assertion Rico law, advanced previously with XXXX adjustments audit period for billion by rates petition of without XXXX resolved the never and The $X proposed to approximately over IRS be in and in transfer And advanced by notice to XXXX by be These plan penalties. pricing approximately proposed for had could U.S. by firmly XXXX tax period. XXXX XXXX XXXX and in to XXXX previously which will Any XXXX all documented change has transfer are reduced based in billion period. over consistent the dollars, tax has time adjustments pricing required be manner expect believe since Puerto press adjustments years. and to reduced additional under the to the for XXXX methodology income XXXX. the IRS You've multiple regulations, relevant IRS also in read We for discussed pricing that that in the adjustments XXXX the between period to Further, the dispute. The be beginning imposed from for expenses for to and XXXX. by the the the multiple The its X/X to the totaling XXXX XXXX difference from income before Any the to pricing tax is expenses. and appeals tax has audit a IRS

We in are our and positions highly in litigation the confident dispute.

to colleagues patients. Puerto ongoing Rico important patient to We in all their And of our Amgen's every are and highly serving now to time. grateful contributions serving back the of mission every skilled of mission and

Murdo. in the colleagues strong the the and every that it deliver update. financial business of given This outstanding confidence for growth dedicated of Our the and remains now I'll over strength Amgen to XX,XXX long-term of patients. turn concludes day team our

Murdo Gordon

Thanks Peter.

sales improvements volume-driven the leading the which a U.S. increased diminished U.S. into us quarterly activity sales We sector and KYPROLIS care led which face-to-face own for the volume around for AMGEVITA. world year-over-year, and the BLINCYTO; in Prolia, sales increased products. health our capacity year, and the the demand forces. COVID-XX variant for receded, EVENITY patient of several in double-digit first and increased our globally and growth customer reduced Repatha, impact First for to also days additional continuing volume record the quarter in X% Omicron Provider our we in Omicron in and working increase engage April, In strategy, interactions. affected to two of allowed in progress QX. to continue to and have to including months March as led our products, business delivered product growth X% In

let volume health, Prolia, with bone XX% portfolio includes portfolio, our grew General Now medicine Overall XX%, Prolia product In our me markets. review in of Prolia portfolio, and Medicine in our for XX% sales complements Repatha the which Aimovig. revenue grew Volumes with by $XXX EVENITY, by million new some beginning our volume an general details, had growth. for year-over-year. grew across sales fueled and strong repeat increase bond XX% which EVENITY, growth both patients. driven quarter, record year-over-year

grew in the XX% the by significant declined China's focused market Part National growth U.S., from on the XX% support cardiovascular to inclusion penetration saw PCSKX higher in and List driven globally the sales Drug broad class, of growth. access. to medical sales high-risk the Moving Repatha, volume Outside rebates January the growth. global selling Repatha we address XX% with We prices beginning as Repatha Reimbursement strong year-over-year, volume need Medicare commercial in D XX% coming U.S., X. increased offered unmet Net treating Repatha leader volume remain on And we to patients. patient increasing

received treatment. use of psoriasis increasing mild for anticipate co-pay our X% year-over-year pharmaceutical to in support a enhancements the using patients. psoriasis. Otezla by We're quarter. portfolio. Otezla lower Otezla seeing levels treatments U.S., of been declines well driven U.S. were signs achieving patients, expanded net inflammation patients net of share physicians growth our Otezla to recently across dermatologists for and price leader, has new In price psoriasis. and saw sales more XX% providers are channels. new a of and in payers, to the declines majority we the delivered systemic year-over-year first of U.S. Globally, inventory the Otezla's the patients market early systemic X% strengthening primarily who and the with Moving to programs specialty by for Otezla agents wholesale volume due mild label to the the bridge in decreased market starting and remaining

XXXX. expect lower year-on-year the remaining forward, erosion for quarters Looking of price we

by growth efficacy our track Otezla, continued the supported volume broader in expect given in by declines Enbrel's unique price indication of sales driven of severity first driven safety. broad the adoption first psoriasis. Enbrel also net of quarter, levels. inventory quarter, Year-over-year, the and long of for volume remained decreased record selling regardless year-over-year by We and X% flat

is positive. a awareness state since very from is first of to providers feedback than in million our programs. TEZSPIRE unaided payers, strong patients Physician's quarter. launch, with launch off to sales by greater supported in increased start Initial XX% and disease Our the $X education

a access reimbursement TEZSPIRE's are acknowledge as of unique July benefit worldwide coding any is to phenotypic eligible pulmonologists X.X medical expect who for and and its the uncontrolled limitations. treat without this biologic of the which biomarker permanent front, asthma or On product allergists with TEZSPIRE year. and we severe differentiated patients properties X potential broad Both million

XX% to with Nplate which continue business, volumes sales growth we grew our this X% KYPROLIS, year. to volume and strong XGEVA products hematology grew X%. six Moving throughout the We year-over-year from expect innovative declined while growth. and volume saw XX% BLINCYTO oncology year-over-year,

launch been physicians quarter, growth. the first is launch. U.S., X,XXX Our of In LUMAKRAS of since academic prescribed community with settings both X,XXX revenues patients million approximately in in representing $XX XX% well the quarter-over-quarter over by and progressing has LUMAKRAS to

biosimilars their electronic U.S., increased our XX expect the LUMAKRAS U.S. access. we while we of AMGEVITA by is option KANJINTI, countries tested hold approvals the in result is and the turn erosion. with therapy. we're nearly I'll well by shares, opportunity MVASI be it price strong beyond as an patient. world biosimilars, U.S., not approved of to when leading XX% biosimilars our new United in progresses The the reviewed ensure patient strong declines, patient of the LUMAKRAS coverage and been executing both expect recent against KRAS with or status, has selling the time, by and to Over volume formulary ASP is volume ensure Sales our January around year-over-year, in XXXX. of with has now GXXC portfolio. to launches medical the in oncologist long-term of chart deterioration Outside record beginning continued that, patients strategy the molecules in Kingdom business XX% GXXC discussed XX% for Dave. sotorasib With patients Overall, KRAS and/or addition driven the with that reviewed available growth growth is net States declined the approximately and in payer oncology in having United in the and to available Japan. trends the driven reimbursement for improve first-line to While our additional are across status and test the care our always

David Reese

afternoon, Good Murdo. everyone. Thanks,

OXXX. continues anti-OXXX investigated dermatitis. heterogeneous underrepresented patients Rocatinlumab populations to expressing Thus, in antibody inhibits and unique T formerly lead Americans, number. atopic Its reduces binds overlap. prevents designed the execution patients our was of being of clinical in focused continued cells cells Beginning innovative the study, profound corticosteroid we reduction X to participants, many evaluate monoclonal to mechanism in pathogenic R&D and quarter potential PASSAGE disease TEZSPIRE designed with of T activated moderate on control. effectiveness severe AMG rocatinlimab, The as Phase in use two and to oral asthma. to one pathogenic with smokers the XXX, real-world Xb Black First where pipeline initiated inflammation, such opportunities. with on with oral demonstrate comprised rocatinlimab in of adult has corticosteroid we severe asthma-COPD activated TEZSPIRE Phase WAYFINDER expansion additional studies in study therapy adult action, progressing potential for rocatinlimab participants robust first-in-class and their a an in long-term X including planning Phase adolescent

disease results In last of our in initiate provides rationale we portfolio, with remains on safety severe rocatinlimab In STELARA, between differences with X of achieving comprehensive longer mid-XXXX. track dosing met demonstrating preliminary the in to XXX program, XXX endpoint, STELARA. from for biosimilar patients clinically primary X a announced evaluating psoriasis. ABP adult Phase the addition, Phase the a intervals, week, ROCKET, to this ustekinumab, to plaque efficacy compared study the moderate modification. and The and no study efficacy ABP prospect meaningful

survival LUMAKRAS. we LUMAKRAS oncology. objective the benefit, analysis rate with tumor These presented AACR two of which treated including KRAS observed at cancer with of data that patients GXXC central roughly X/X of years, a mutated on were XX% XXX to clinical review. response this demonstrated month, the patients a overall and trial, outcomes showed with alive Earlier lung response by turning from CodeBreaK at cell long-term Now data non-small prolonged was advanced the still also two-year

control outcomes While reported this anticipated population of this historical compare data. follow-up based two-year new single-arm safety was patient a course the arm, There efficacy favorably were signals with data a trial in on no analysis. the this without over

data combination for lung lung updated summer, comparison and initiate patients our combination Phase LUMAKRAS We a and cancer PD-X a taking in the study in line of in medical from used track confirmatory the small X molecule study first-line congress from submitted we cell results while plan the and summer. study cancer relapsed/refractory BiTE tarlatamab Xb SHIPX with Also medical extended top LUMAKRAS late place QX, the have on cohorts tarlatamab, of to submitted docetaxel quarter. the to late being are And setting, with half-life in dose combination Phase X DLLX-targeting lung in standard in cancer place have versus care testing respectively. we the this cell DeLLphi-XXX, data a to small taking Phase congress QX

are patients against FGFRXb. squamous enrolling study cancer, we bemarituzumab, Finally, cell of Xb in antibody Phase a a non-small lung directed in monoclonal

ASCO XX to in where heavily across at gastrointestinal rate pretreated LUMAKRAS patients. We centrally of February, disease pancreatic plenary the XX% response confirmed of cancers. control data rate a objective series Turning XX% cancer advanced demonstrated presented and

The cancer, from continue as of monotherapy FOURIER oral We the in announce Repatha bemarituzumab pleased In results colorectal a In X were setting. with combination the third-line of agents is in LUMAKRAS other two stable study than Repatha safety FOURIER disease has patients with X,XXX this years, results statin long-term trials, we study atherosclerotic studies, gastric LDL of adults of therapy. clinically Repatha been more benefit high-risk in for tumors cardiovascular Medicine, evident in the extension studies received aggregate chemotherapy initiated. Xb with with and these safety regimens X.X combined overexpression cholesterol. OLE and Phase effective General reinforce Vectibix the years for patients of on to enrolling lowering plus up OLE and in open-label long-term tolerability with combined Repatha to five the to Repatha in studies. some explore receiving when studies approximately cancer, assess across LUMAKRAS FGFRXb OLE, In a designed the patients. from Phase the In to and tolerability

these sharing of by and spectrum benefits forward extremely seven this are back benefit important extended it biosimilar innovative this with to in reduction the We turn for to portfolios results to cholesterol Repatha congress about past patients with and throughout LDL-cholesterol medicine health execute outcomes. year. I'll sustained on data our the learned look is of for Q&A. that, medical their With of disease across community get are data what LDL We cardiovascular encouraged the number conclusion, crisply These of level cholesterol. look the That at has robust sharing who recommended still affects we targets. a rest over our to to cardiovascular struggle and new decades Bob later the of a consistent forward the year. sustained patients programs lowering In below from continue the care the

Bob Bradway

callers our happy to could questions a question, RJ, Dave. of now. we're submitting for answer process remind you, the you Thank Okay.

Operator

Michael from of Yee Yes, Jefferies. first Instructions] the from sir. [Operator comes Your line question

open. is line Your

Michael Yee

Can okay? me you hear

Bob Bradway

ahead. go Mike, Yes,

Michael Yee

quite out. approvals that important have Very field just for confirmatory wanted whether Phase Obviously, paradigm very the and good. I the a result your competitors expectations KRAS X docetaxel, is you how fast accelerated you Dave. around changes for competitive know to for you. around study a that and confidence file the could Question reading positive for there against LUMAKRAS

So that on comment the and study maybe just ramifications.

David Reese

course, docetaxel, very If confident I FDA been against with that what and would we Mike, how of for the Phase we LUMAKRAS, other so to the quite in think, with regulatory of point. We terms would, which, the be the be around has these moving approved we've X will on. data briskly, this competitive positive. likelihood observed The world. I'll decades, we're course, others and replicate focus But bodies, now. discuss file far trial program on We're at full of in move with to countries forward that around approvals is leave right landscape. in LUMAKRAS XX to very and the comment forward roughly in effects our that's confident

Operator

Olson next the of question Jay comes Oppenheimer. Your from line from

line is open. Your

Jay Olson

the As strategy generate to what cardiovascular there? business you for Repatha, you you Can XXX for published just saw development you for data strong failure. in in about AMG for AMG seems data continue new clinical an coming to gaps you're important increasingly data I recently It Olpasiran, building like XXX, heart your cardiovascular talk are cardiovascular And portfolio portfolio. disease? your opportunities where are large want And opportunities? any there pursue may

Bob Bradway

the of first? piece don't why don't I'll that, to respond start. take last you Dave, the I Why and

as Murdo well. Thanks, think Jump Jay. comment wanted to Good. in. I

an question. you raised I think important incredibly

forward. aware, morbidity LDL and commitment in health Repatha. that, comment focus in the of disease of remains all globe. in part, one is of areas with across a of you're minute, spurs but tremendous going of the in an for medicine therapeutic area And is cardiovascular As believe number public It cholesterol. we our terms It here principal terms areas the best probably one for patients what three opportunity will hypothesis burden remains there research. in Murdo mortality on our that's to a is proved serve us

AMG XXX. Olpasiran, You or mentioned program, LPa the

the important atherosclerotic LDL outside the pathogenesis in of everyone, Just single probably most is to of cardiovascular of terms cholesterol driver LPa remind disease.

possible X in Phase programs. As what Phase Phase couple we of Xb to saw transition I data X. noted, as goal we're looking replicate those And over forward the be data those months, if would next our quickly to in as

it this a indicating to I next turn I'll addition, Bob the portfolio, research Murdo, then our and to very we commitment you active In talk can have area. ongoing strategic preclinical development. think, about maybe business

Murdo Gordon

capabilities Thanks, built and huge global that and growth global on and that of growth to our XX% volume medical obviously, year-on-year. support reach the cardiovascular XX% commercial disease need is Underpinning, we've the population of We Dave. Repatha, to sales business. patients, unmet footprint reported ability medical

So and feel for these also clear made us think great we of clearly medicines patients. that's progress. I improving affordability that to now, patients. to more do that We're our these momentum have very the there's we continue for area for And are we've we another focused on that

to own So is very I team And Repatha that adding not a thing. only but welcome of pipeline with the Dave's is internal also think to improve is the of long-term assets, hard, our course, on strong. the with And on portfolio working ongoing. follow-up Bob pipeline disease which in trials the And the it is trial, that were development. Amgen profile turn I'll so the VESALIUS to cardiovascular business of over continued, announced recently profile

Bob Bradway

it's to Yes. our innovation find Jay. simple, challenged And We've very teams research to that development and can attractive our add we externally business there, portfolio.

So value add can and we day cardiovascular in disease as diseases in we're inflammatory to well looking for things every in as that cancer.

Operator

Your from comes next Goeff of question the from America. Meacham Bank of line

is line open. Your

Geoff Meacham

this more dispute IRS about year. on compared earnings it last to when the Peter, with commentary a you call the talked lot tax first on

investors I think probably a expected. higher number of the

you going discussion? today? appropriately agency prompted something make then the has resolve, tax it, And that's the So number? to then you there And that discussion over going fully when take just change service fully a I that stagnant change. reserves or it's your that of to you'll been would be course to broader that the resolve is years Or with a know to but the is, language question recent expect

Peter Griffith

vigorously comment where we in IRS Look, in secondly, Yes. manufacturing. the than territory established. litigation, we our between understand, in of complex, we proposed you merit. United investments. you IRS the perform are as billion we of capital Goeff, skilled and Rico on We're Rico And highly majority then comment XXXX so Puerto that our reserves we're States contest and X,XXX to without Puerto said, as of that thank positions -- the as those first. Rico, very manufacturing XX-year simply believe is global can don't X,XXX XXXX. with the wouldn't a position to going terms this about would at allocation $X -- U.S. over on we're our the the flagship profits for of we've discussions say reserves we we we we presence, the through other Puerto confident we're on home just for is that And said, reserves, and where wouldn't question. in of level employees, adjustments the of size And the

Operator

question comes Salveen next Sachs. Your Goldman from line the Richter from of

is line open. Your

Salveen Richter

for status combo LUMAKRAS, here? take study drive And On ensure that out is steps the also physicians outlook to with recognized that's frame can summer? reading KEYTRUDA GXXC late prescriptions you you in could the what to by

Murdo Gordon

are have Maybe then all I'll they whereby Salveen. question. patients. Dave with for their data the literally start for over Thanks, to of ready and oncology working systems, oncology internal extremely closely short choices turn particularly What the own in a providers things networks status new it fingertip things GXXC that seeing of they We're for biomarkers, resources enhancements, diagnostics obviously KRAS making little improve to the is of on their and treatment with constrained U.S. can the effect. workflows in better Many we like these like staffed biomarkers. against that EMR against and are hangover bit deploy COVID large a

account literally networks, account treated seen is very by huge across They're patient we made large the centers. XX% the community working in of improvements, So treated. country. we've base community the is and some which We've oncology are where

patients testing for I who clear, progress. care the test the think very academic in The the strong, institutions, results available is robust. and is are

community really setting in U.S. So where the working. it's we're

ex-U.S., a As see different pattern we look country. we by

an technology and good France, you of that. indicators may has uptake charge France, recall, in called few and that there program early we launching already where Germany biomarker clear ATU actually we the So broadly. weeks Germany, in and And expect and being access as just a an have early like that's we Japan. systems can already for program product as we're very countries old we're and seeing advanced fairly are used

slips project that with we're through. commercial network So medical intensely to make colleagues, Dave? I patient working network teams our no our with think a sure that by it's

David Reese

thanks And the question. for Salveen,

data one as terms summer we've submitted conferences. of data In noted, availability, oncology of the the we for

with out to and cell things the PD-X lung patients looking non-small examine one I'd are inhibitors. of of whole we're point at also approaches that population combination the both cancer. sequential with beginning is We

third, PD-LX PD-LX instance, quite combinations them can expression; checkpoint PD-LX have intermediate chemotherapy. and at is an PD-LX effect LUMAKRAS roughly You the tumors, third divide inhibitors for into of population, high straight area with looking negative In X/X have load negative that's of expression. are and the modest, we where are

expression, as field evolves vary crafting accordingly. clinically we our And the mind, depending on development may approach PD-LX as are program So, to is in one thing well. that this keep

Arvind Sood

RJ, let's take next question. the

Operator

from of Your Matthew the question Stanley. line Harrison next from comes Morgan

is Your open. line

Matthew Harrison

afternoon contracting Thanks. Murdo, Good commented we your around the review thoughts HUMIRA and I XXXX? a of a Any other as XXXX HUMIRA Great. specifically know just think business maybe biosimilar your Murdo. expectations you launch thoughts some on and around versus for question hoping updated comment specifically how going in for was about can products. or contracting of both terms the that's you

Murdo Gordon

Thanks, new update to Matthew, lot you have for the question. No, I on. of a really don't information

solo. as that actually we that feel that to us the among only first, like for -- like a continue in as rheumatologists We recall, you'll potentially commercialize positioned use not Enbrel commercial of have profile of be XX. the the well dermatologists. we're XXXX Otezla we GI January a We market existing We and our intact the organization relationships and in competitively the have to for if inflammation well first, supporting with currently footprint time opportunity biosimilar as period given extremely and

that So, got payer we've relationships. customer we feel relationships. have the definitely We the

available every as time patient the product manufacturing benefit every the of managers make biologics obviously make to to for supplying have our years provide early pharmacy as possible. confidence We and decision to XX

then, we about So have launch course, opportunity. AMGEVITA thereafter. after of the in and we're U.S., launches Soliris the the launches, excited And additional then EYLEA, STELARA of other several

focused. we and in It's the ensure new to capabilities have growth, biosimilars the our six area long-term we're important into where to an so this for invested coming this us area. We've is very success. market, So, market in the

Arvind Sood

the question. go Let's next

Operator

line Yaron Your next Werber the & Company. from comes of Cowen from question

is line open. Your

Yaron Werber

you, that Murdo, maybe, relating in IRS? team. but Great. of the Peter, is Or and that it's And first, the to or expected. year. tax I the to increasing Peter, U.S. the litigation be for is maybe rest is rate for different this with you, for lower for Are Is ongoing growing, LUMAKRAS for going we reasons? guess, you size guess, I the poll U.S.? similar than you then expecting incrementally the the ex-US to bigger

Peter Griffith

Yes.

Murdo I the part in jump take think wants first of that. to me here. Let tax don't

point should only So basis to related which not that look, earlier, question the more response we're now. commentary in Yaron. Goeff's good by And is make moving it all It's XX bit the a maybe up to highlights litigation. that I points. tax at little just why

this because all for for is to understand the folks, think to why, exactly calls. it's conference And we our think you make analysts. is We this position. complicated struggle I for prior of just you, want a that a this area been understand sure

But of provide not We're Yaron, level of question in it's position background related on you in the thanks So And be wanting the for some to confident at more itself, want where we our we're the case it. that more question. on to But it. reserves all. at. we're again, just for in specific

helpful. to get back business. Murdo that's over hopefully, So it to to I'll And now turn

Murdo Gordon

Thanks Peter.

say when to of of treatment status at GXXC We're is to point XX% line. treated LUMAKRAS. would known those getting KRAS U.S., over in patients what I we're progression by be seeing on. the that You're is from second with first-line LUMAKRAS the

population the identification the penetrating GXXC we're the status of KRAS So is when there.

need I to with the line really question it line So this can't first work. is clearly not have an doing to we're urgency And we and patients the book earlier, from second progressing LUMAKRAS. lever as have of that really account-by-account Salveen's we ensure answered of And choice that's improved. because

this disease So similar patients. of and that of of cell cancer overall between I epidemiology size. is that Europe versus the for we're U.S. When work doing ex-U.S., we U.S. at would terms important the the lung in the non-small incidence look really is in say

go as GXXC incidence mutational Now Asia, to is one the thing into about KRAS as just status you think a lower. bit of

have about X% KRAS as example, it's U.S. take GXXC cancer Japan to lung an in patients who non-small mutation of have cell the a XX% also If you that compared

mutational change outside and the epidemiology go U.S. you when does of Europe. little a So,

the would the it rest world. expect of bigger will be we U.S. than slightly be the So, in in to business and Europe

Operator

next Umer comes question from Evercore the from of Your line Raffat ISI.

Your line is open.

Umer Raffat

I if may. two, I guess

that patients X,XXX court have a And U.S. those Peter, guide what because interesting in therapy March. one model has on put somehow probability third-party sets is I'm on drug Crude at with look two. topics? could up when it on your that the this on like hearing to taken an and coming the is their math commercially. can very and feel would patients on were disclosure would suggest resolution, or March certain data line on through the duration X,XXX About of square line consistent for And tracked patients exposure. that in helpful. dates trying were liabilities observation? so. secondly, KRAS. five-ish on time could side, perhaps sets time X,XXX There's -- when having in X,XXX suggest will us First, tax months a would people of of the you therapy total or on And like perhaps slides the what Now the how be is those least, key sense or Is two tax look that core I code, for there's like the at very in a then the

Murdo Gordon

of the duration patient perhaps therapy. Yes, and regarding numbers question first on

to we've numbers X/X conclusions you of third to combination very the product were about a one who late-stage on data with little be challenged where by numbers able versus it's draw of get do alive Whereas patients see having mark. patients potentially line as or being drug What patients to more do a from patients were quite therapy. well prior I experienced at we bit maybe well. AACR, got the understand, premature indicated didn't very in disease, I to is the will think steady and of DOT X,XXX therapy second-line the need out two-year follow-up line at long-term you duration who be treated put the to guess, could follow-up just that beyond and who of state

I to existing too infer of it's what be. what look-back patient need therapy really your effective in-market understand numbers is in is say in period understand early this And XX to your will actually So fact, to I therapy from what duration is. to of you market understand often the think duration months

know our we So will going quite to duration be. before real-world some time therapy what it's be of

Peter Griffith

Peter here.

thank So, you. on side, tax the

consolidation terms notice XX with Tax Court mentioned, I of will will through we case. petition the contest XXXX-XXXX judicial take the as U.S. as to And process. vigorously filing steps of line, days. XXXX and through we this court We within several it plan for with a years And the resolve itself. tax the XXXX to see XXXX XXXX I next time said, will In to period be ongoing

we as So it. see that's time frame the current

Operator

from Gould question next comes Your line Carter from the of Barclays.

Your line open. is

Carter Gould

the TEZSPIRE. and sales was the in extent that's the an drive a recently. color then there source J-code you impediment that importance focus the to second of In results. an talked the WAYFINDER you past, I of guess the to of about to little think to for looking guys date. been the more started you obviously, could bit how And I extent Maybe inflection kind importance on there, specifically a get and down

that that there So to or be about sort addressing would critical WAYFINDER, is think helpful. have color of we nice in as gap simply some

Murdo Gordon

phenotypic We're product of do, severe treatment Thanks, such TEZSPIRE a TEZSPIRE. by their for unique a the treat simple uncontrolled the Carter, asthma, that limited patients on the novel, question or else being solution market can really regarding that have so to they're biomarker status. much who the for simplifies excited to response particularly about by really pulmonologists profile where having looking without

clearly assurance mentioned, they that their in billing going it's think and appropriately can It's gives degree we product providers be permanent benefit the reimbursement. have X. have to to a really which, confidence and on of I well. code to overall, staff So July a as a That will high the market, J-code coming

I it's also for think reimbursement practices. they of to some know tied the reimbursement is but now, happening these

expedite knowing cash permanent the tight And reimbursement J-code Some to flows. of will should the help. actually them time pretty run that

say so we're really helpful. to And patients to I providing who is clearly I'd step say good. response the the product of currently we'd process on half for that be the back But sales additional and reimbursement be to growth force they yes, in year. going that that yes, But are would it's going So in-market through get medicine. can therapy have the looking sales access in --

David Reese

can corticosteroid effects of trial, sample believe, Patients size on at the time earlier And a Yes, And at we're size a single-arm more be a in over the XXX points. dose The trial, WAYFINDER, trial. sample much this taper. is some We address the of we looking Carter. believe SOURCE There patients. It's methodologic rapid be will higher in limitations. earlier terms we of steroids. larger. can saw

confidence effectiveness in All see the setting lowering of TEZSPIRE of give we will oral corticosteroid think, of us use. that these, I

is In we're the forward. profound this be showing a meeting in the drug on other confident at for I addition, of the data of going and exacerbations very in from think to development a really a in presented oral recently across trials quite range going corticosteroids. Again, important AI updated patients Quad we reduction phenotypes, and treatment NAVIGATOR asthma program

Operator

Truist. from from the Robyn question Next Karnauskas comes line of

is line Your open.

Robyn Karnauskas

Repatha. So just a couple on

growth thoughts Are trends early previously with you give a as that, as could second little bit by more cardiologists impressive more drug mailing. impact seeing Maybe the thoughts in lipidologist color your can of you was here with continue scripts on by second, have on days, just on the in your prescribing the confidence half think that the And some versus Repatha. So Repatha growth a that you is permanent year? on you and July J-code the script inclisiran then far who give I the coming doctor. just it trends in

Murdo Gordon

Robin. Thanks,

actually consistent the the cardiology evolution growth with community. Repatha. fairly The across is We broad are pleased of

We're general not just seeing of So cardiologists. variety your a podologist, it's community cardiologists.

for networks in establishing end XX the in don't for. or their high-risk effort other treating hospital the We delivery panel, integrated initiation way have more an unfortunately, on facility admitted acute in many we or lipid systems million some discharged U.S. patients recommendations them successful also many up of get they've of care of appropriate been that and a of have get a MI that standardized large focused where events without And even and them ASCVD a been treatment.

clearer and reduction. then care. cardiologists and/or a care we're bit, And community quite on cardiovascular improvements therapy up discharged quality are that being stepped more those primary or with intent aggressive seeing we've the risk lipid-lowering patients physicians So to of

So that's helping. definitely

also going continue growth, we're invest we're that with in seeing we're work obviously to that care. the care, to continue going expand U.S., but in that primary going to primary to we're to prescribing that we're future For given and IDN effort, incrementally some going spontaneous do

other is a a been mention Repatha And doing So we're I ASCVD that the an country. China List, team the the is very patients there. Drug the for our thing that has pleased which listing Repatha in with Repatha. is us in in nice growth Ex-U.S., would good of X option of China ensuring high-risk for launch National job Reimbursement we for got Jan

a event they're can With risk patients even world. in the we've in now a around continue got there's world about reduction, we we've it. primary population, that's of large about tons and patient the reduction got with can cardiology, aggressive one amount think to severe more the everybody product. growth they a and So the market But for market. coding, and on that and we given limited cardiovascular I competitor lipid-lowering of don't build promote. to for really, to think and need that bear killer of about patients good yet that obviously, headroom people I this the there's disease, can do respect have number talking need again, what concerned lot that this a in data, and more large they still aggressive in therapy there see what we momentum out into reimbursement But they're care inclisiran,

very we're overall, bullish. So still

Bob Bradway

the got And just to up probably to colors want know go ask the few of a we've heads still minutes I callers I that the give hour. several RJ, hoping we'll over top questions.

we're take team the later. to obviously, and do we'll unable question, Arvind don't will if why that, So, our we get to then do we'll, And to be and his best available everybody? next

Operator

comes question from of next Your from Bansal the Mohit Fargo. Wells line

is Your open. line

Mohit Bansal

question on a Maybe TEZSPIRE.

it do is is, needs of that self-administration Dupi from the be future of to a a given administered So given do provider, could that -- And which up reservation help self-administered agent, expect for become kind possibility what by right the the there administration. at-home is you in now, that a this injection, could a prescribing actually at you doctors point with terms available you product. it self in come the question

Murdo Gordon

many care uncontrolled a are severe that allergist. because asthma, an Mohit. is especially condition, patients asthma Thanks, an these acute under of Unfortunately, severe are pulmonologists of frequent such

very I And the side physician-administered allergists, side. much barrier are given is biomarker but think our to initiation used regular And do so that side they in seeing been a playing that launch, of days What particular, assessment And a of of administer. seen their to it's out course, basis. dosing, month products. very they're administration in has a physician once physician fairly I TEZSPIRE. is convenient easy the the feedback or to early phenotypic not less is this the And the on it's think as on benefit the product have work to really

to test looking in life think convenience buyer. that over that we've and indications we we'll what continue so ensure maintenance evaluate other do patients. for I to obviously, need do opportunities And regard. simplified cycle workflow there's and haul, we're their the for at And long other to

continue to provide continue to not product to could self-administered or be mean, assess the way, look So that we'll that. clearly, we we whether a at want option. I developed and

Operator

Your from the James. Dane from comes next of line question Raymond Leone

line open. Your is

Dane Leone

effective, investors on XXX. me. equivalency of competitor How reason actually that of coincide the year? playing are will this the a at the you the a GXXC is, we of dose LUMAKRAS into the dose dose the And being just on a any would in that of get to at quarter. study Congrats Presuming expected it, presumable demonstrates that does lower the XX-day equivalent is turns question XXX-day equivalency that frame One of And thinking if enacted script? with XX-day lower a equivalent? the obviously, transition Just seen XXX-milligram the from space. script this? how script is given that pricing this managing to managing end is launch Q-day from lot if is the end year, being dose given Maybe is equivalently show for your team that question be to as KRAS there change

Murdo Gordon

given And if to able a clearly, see dose. product a pretty I remain can lower a clearly, of for to What follow-up benefit approved that data, say it's we off, safety looks high Yes, dose dose. detailed very confident would the right good. us first is be and the efficacy is, it bar And it's long-term upon be at that the XXX-milligram the hypothetical.

But continue your it. best variables the answered. what at I because can't to the would say answer continuing is, patients. be that's there's many provide way, guess, The So right that question one remains for to to treatment the so different I look way we question complicated I directly to

lung So if been you've patient, second-line cell XXX. non-small you're at cancer prescribed LUMAKRAS a

not is to you're want oncologist stable. patient. You're and any your you're taking sure I'm it, you've to continuing lower dose, if a going responded

seen dose usually on who down, might stay where a we've a either where stable go up that. areas change disease that or dose other there to have been Now patients are in on go to

guys your commentary to handle we'll data us see we'll what bit to question. and of the additional it and So to my what data wait one we'll But do. the that according the would and FDA be say

Operator

comes next BMO from the from Capital question Evan Your of Markets. line Seigerman

Your is open. line

Evan Seigerman

of Otezla have the December. one spectrum as full to label last now from we I the approval or Murdo wanted that ask on kind full of

those seen of the color of expect these edits have for any patients change to over sort they the get patients pretty get on in sort to barriers So do or freely? course year? it you Just love patients. you the able how any go marketing to it step mild need more you're pushing of some Do that to to or are

Murdo Gordon

Thanks the regardless of PBMs expanded ensuring really for from Evan. with of the label and payers access severity to the No, for the that pleased good question, can response affordability the now have we're product. strong and psoriasis patients

versus year year. improved access fact, we've In this last actually

some of percentage. of some medical the percentage prior had described produce like a surface able of prior as there been area. things to There we've authorization policies We've those where So, many body are removed. criteria, that's of are authorizations

the experience reimbursement And what to that their prescribing for past easier experience many in milder was to up milder like of back March in at year opened I to and I Otezla was. to and us many and what asked actually for we've access them think Dermatology patients. had prescribe think patient. those the was the was that patient. spoke Otezla played them dermatologists I of that than And American that So Academy for it prescribe been meeting

we that well. own our bridging go did we co-pay would was ensure The to other thing and that, systems enhanced launch programs our

being so I don't far, good start, access anticipate but off impediment. So an good, to a

Arvind Sood

RJ, hour. the folks past in East on to the consideration the it's Coast,

don't So questions, more take we please? why two

Operator

Your next question comes Kasimov from line Cory JPMorgan. the of from

open. line is Your

Gavin Scott

second assess doses the administration. and/or It's I summer. And lung line front question the forward? different for Gavin Or predominantly a in in dosing also be is to line from just sufficient or this there a on plus? the a the look multiple path then will in on cancer guess if us earlier we patients just can you remind should patients, Cory. of combo pathway data for pembro had late the I queue follow-up LUMAKRAS

discussed versus other past dosing you've strategies. think sequential in the I

David Reese

beyond. Cory. and second and Thanks, we combination first-line, of patients are sequential Most limited will across Maybe be there experience with both doses Yes. in range of a is line those and a looking therapy.

So of expect presented. see when to all that the you data can are

Bob Bradway

couple a one Let's and going take last concluding comments. Rob, the make to RJ just of after question,

Operator

from the from of comes line question UBS. Colin next Bristow Your

line Your is open.

Colin Bristow

quick. I'll keep this

was whether on view XXXX? Or essentially as being just really scope quickly just then is this small limited data talk LUMAKRAS, you set XXXX? saw investigator-led about we path a through there with to closed quickly on your to in should with effectively tax ELCC issues. to Could PD-X. Just to elevations this dose the there the And a for at And high few you permeate was about rates LFT sequence LUMAKRAS We there? dosing. how relatively just forward combo with can else versus curious the anything ago. weeks say I compares some of this own experience sequential presented

Peter Griffith

between Rico profits we're States. case, Colin, how thank had we've our very in you. structure Puerto Look, and the on allocated the and confident the position we've United and

we're very reserves. So confident in those

If in in 'XX. how which reduced beginning applicable in States articulated between I you by adjustment, we're which in did that forward, again, very and and approximately level is release But through those the the differences any we're rates tax about change Tax adjustments the the of in they once be rate Rico XXXX think United X/X IRS structured reserves. going propose currently the the confident suggest XXXX magnitude the Puerto tax from by our confident the press we're XXXX. pricing of very Act, is transfer audit, in If auditing the did will the did lessened

don't changes And any going forward. anticipate so we

Bob Bradway

that? Dave, And piece the second to you do of want to get

David Reese

were our data that I monotherapy inhibitors. from receiving than higher you in with checkpoint to potentially have and of can effort. program after data, uncontrolled investigator ongoing France, rates the Yes, the through ELCC clinical these toxicity regards pharmacovigilance hepatic our tell in were patients observed an we trials

that It's not for why sure further I'm on any hard but So heterogeneous data. case, was group comment was it a us unselected of patients. those to the

Bob Bradway

dialing interest for in. your support appreciate Company. thank Let your of and in me We all the just you

the together we're report we you. well calendar through quarter tried Thank you after we've XXXX progress convey here our to second back executing to with being the As this through feel midyear. call, we look into to on year. forward And the

over. Thanks. minutes Sorry, went few we a

Arvind Sood

Thank you everybody.

Operator

Ladies and we conference gentlemen, this for all concludes participating. and today's you thank call,

disconnect. now may You

Amgen (AMGN) 28 Apr 222022 Q1 Earnings call transcript