AMGN - Earnings call transcript Q1 2021

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Operator

My name is Erica and I will be your conference facilitator today for Amgen’s First Quarter 2021 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 Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

begin. now may you Sood,

Arvind Sood

Erica, thank call. to QX everybody. Good afternoon, Welcome our you.

I this your to themes focus key prepared stick think X the of format for question. do best growth limited pipeline an efficient we’ll and on and quarter best advancement. but Lots addressing cover, comments our to one volume-driven continued are

slides So have been posted.

we’ll in our Just measures a presentation. financial quick use non-GAAP reminder, that

forward-looking be And some statements of statements. will the

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

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

Robert Bradway

March. holding we to in first in well. seems January especially the the pandemic competitive Last Okay. thank of had something as a of Thank if performance came recovery pandemic, strong the in our the be a reverse. you, March, a strong year, we to that then Arvind, the and this aside very a for globally. We brands that’s and of executed ago. quarter the a the with hello, mirror Setting and impact everyone, we call. the of it and in We feel in recall, XXXX out U.S. February, reflected January and pandemic really This in was effectively in first February, you to see felt and and started trend April began a image year, busy and quarter almost is you a to experienced impact of gate to the start the our we joining what year

addition Phase-X-ready confident in our progress lead oncology. is Altogether, biosimilar full pipeline of outlook. in molecules year our rapid strong remain Our the molecule and we the attractive an of showing

It growth. the soon diverse We’re quarter. X portfolio products milestone volume in the million continue patients the PCSKX and have delivered fortunate a will clear reach served. to globally, for market the of example, XX% show first growth remains leader strong of Repatha, volume that to newer of

generating We’re in health quarter. global bone Evenity volume double-digit leader of and also the the in with Prolia

biosimilars billion forward industry-leading and biosimilars new we $X the a few of X and for launch years. look have flow next And portfolio would Our you opportunities is of AMGEVITA over I above that X development additional to in remind annualizing Phase mark. the these

in As we’ve many developed our shared is internally of to opportunities. we’re of in Therapeutics Prime with example external with acquisition looking compelling you business past, times development, a active the our good innovation recent Five that. And complement

U.S. for and LUMAKRAS to now third been provisionally the has the use for has that medicine is late-stage approved now be tezepelumab sheet, which Therapy that clinical opportunities With focus. Breakthrough status, sotorasib, for joining look trade-name in stated areas granted strengthen also to us earned and we our our to FDA a was molecules of healthy we’ll balance in designation gastric granted first-line disease previously As cancer growth patients for million than by new our with annually. particularly More account bemarituzumab region, a therapy subset Therapy you the prevalent one the that over which deal, of know, in Pacific will cancer. Breakthrough acquired And is the of Asia as cases X a of the continue ability Therapy distinction. Breakthrough proven strong we’ve are external diagnosed cash in integrate, said our decade. XX% approximately flows next gastric the for Bemarituzumab

our for delivering you, call. over to now, our look a colleagues things the serving for I to CFO, my little forward Peter our to want commitment But Q&A thank and later their for results turn patients I world Peter. our to I stakeholders. to over session Griffith, Before around Amgen continued in

Peter Griffith

non-GAAP further to EPS like reflect guidance. the the revenue and on to take strong business moments our would fundamentals I of to Bob. few and you, full-year Thank a reaffirm

both this. confirm Let begins of innovation. me and with are excellent as and consistent our in Therapy investing It examples tezepelumab, designation, granted activity. our discovered, internal allocation LUMAKRAS always capital predictable in first internally seen QX each hierarchy Breakthrough

bema. pursue hurdle development a pursue our Five and have and funding timely our rate are We opportunities in patiently are other into clear allocated lead focus, Amgen consistent $X of our the indications R&D which acquisition second with shareholders’ business then to external for also basis. and therapeutic additional in confident to integrating quarter that areas We on billion effectively we capital of committed the Prime efficiently the molecule of

initiatives by our ESG Our capital industry-leading and expenditures including neutrality remain imperatives. a including manufacturing, carbon digitization in protein XXXX, investments our enabling priority, high

We shareholders. continue to return our capital to

dividends year marks paid increase of years. This increases per dividends of in quarter, XXXX. the in we of XX% our share each from those $X.XX meaningful a First, year with XXth representing

Second, cost million roughly we repurchased in shares X.X first quarter the million. at $XXX of

capital. always on our results average allocation of structure, capital builds hierarchy in our weighted Finally, cost efficient an optimal capital which

Recall will our percentage exclude year. fair adjustments QX, in X%. decreased Historically, XXXX, lowest are results. of In quarter our sales were equity that of first to results to through that that investments been included revenues the as the comparing XXXX historically Now, OI&E. walk impact non-GAAP recast I full quarter financial first briefly now a value quarter have the we in

of year. we knew variability. negatively March it more cumulative would progressed anticipated we and that impacted, which us percentage XXXX, And saw As would below to continuing on cases likely COVID in be some we would as be the prescribing that introduce led effect COVID that disclose the a XXXX’s quarter patterns, moderately QX we full entered of

volume X% First quarter sales from growth. benefited

in Looking negative XXXX, in a year-over-year on back QX XXXX. changes creating QX impact deductions, favorable sales growth we to of estimated comparisons million $XXX recorded approximately to

quarter, COVID we get we the expect continuing with second to be underway As cumulative there some impacts.

that in expenses to the more While Total recovery see increased year. rate recovery, quarter weighted X% will year-over-year. half for we expect second the non-GAAP be heavily of improvements to the of operating the

of to XXXX, cost shipments to will of first expect will increase product antibodies to sales product connection cost shipments continue a as be sales antibodies in recorded sales Recall XX%. as other to revenues. year, be QX of percent revenue full Lilly. of that from For we percent of with these Effective a in of the XX% our sales

For to year, includes we acquisition. Rodeo spend for decline. full progress, which increase expect the pipeline expect the acquisition we will R&D innovative spend as from the our SG&A now well the as continues bema full Prime to as Five And year,

EPS net recognition Recall Beijing’s focus of on not our loss Beijing’s $XXX our a recording The OI&E in the start a imperatives. for the adjustments was XXXX. recognition year-over-year the the totaled EPS $X.XX deductions, This and continue portion effects Beijing expense sales until of due XXXX QX $XX basis, did in explain in We basis of XX% unfavorable million QX large year-over-year. decreased combined of about million of a decline digitization by to results a portion is the QX. in comparison on Non-GAAP on the with of this quarter. results, year-over-year

of outlook consider, a billion for based billion, the dynamics are to market to plan, for points Important range business to underlying as and of we revenue guidance to investment turning and $XX. on $XX.X XXXX, remainder of non-GAAP XXXX. $XX reaffirming range EPS $XX.X our the model with XXXX the Now, you additional a our

heavily unprecedented specific see on recovery half quarter, the provide to not an quarter. from providing year. we between we XX% second first do COVID-XX impact more for expect quarter-over-quarter And the revenues weighted X% the such basis. the to expect We are the COVID cumulative guidance from the operating But guidance, given ongoing on and more of total to second We grow continuing sequentially environment. the

expenses and increase range, increase increasing about QX an operating year, the mid-teens Investments We year operating by quarter-over-quarter as operating of second quarter-over-quarter the Historically, to well COVID-XX reflecting acquisition, the which operating year, But activity continue operating launch Five the to Prime Five growth to expense over includes Lilly agreement. expenses our levels, quarter the full including antibody for preparation. of of last increase Prime manufacturing expect this in about expenses Rodeo. including as for is impact roughly percentage in X% we non-GAAP expect XX%. XX%, margin with

the continue to anticipate range billion. $X.X to full expense $X.X in non-GAAP a the to For OI&E net year, we of be billion

$XXX end confidence the are XXXX business, range guidance And in versus the long of outlook the prior remains expenditures at guidance of we our our billion million. upper billion. for repurchase to share capital Our based raising on of $X $X unchanged range

billion So range $X our for share in is to XXXX now $X repurchases billion.

to of My XX%. strength Additionally, to business, given strong of we’re it in turn XX% to outlook of to for non-GAAP confidence our update. also deliver that tax prior updating guidance Amgen, of This rate deliver concludes financial I’ll the team is strength the outstanding our colleagues of and versus long-term XX.X% everyday and Murdo? and the Murdo. guidance the patients, to growth dedicated XX,XXX-plus shareholders. our long-term the over XX.X%

Murdo Gordon

Thanks, Peter.

XXXX the driven impact post-holiday demand to missed the that sales which of growth business, double-digit In on did million affected February March of COVID QX solutions most deductions and in number approximately MVASI, were Net our benefit pandemic, diagnoses the January QX product estimated negatively across and from effect X% declined patient was has improvement to into selling impacted volumes to XXXX. the by volume. and the sales reoccur cumulative the due and quarter $XXX price of our to showed the changes year-over-year First continuing Repatha, KANJINTI. visits teams our of April. in by quarter, X% of a affected a grew of and pandemic X% by address found Despite same continuity not declined Prolia, magnitude products, brands, the including care, X% first COVID stabilizing comparison patient year-over-year, clearly for spikes, have continued

quarter across facing virtual improvement communication saw also including customer throughout execution and activities. We face-to-face in channels, the all

COVID-XX recovery beginning recording sales our now Prolia details innovative the in quarter, product health, some in grew year-over-year, the still first In XX% with the $XXX disruptions million expect U.S. We review of steady the thereafter. for time. bone over second some portfolio. U.S. related I’ll

the levels. of XX% diagnosis are majority at As rates approximately pre-COVID-XX a in been U.S. vaccinated have and patients osteoporosis to

$XXX provide pharmacy U.S. Repatha X% starts made This continued to favorable helped the and XX% volume EVENITY Medicare quarterly million growth, increased which sales growth increased manager by strong patient with that formulary the particularly demonstrates Part continue good an by We patient a lives Medicare patients. bone sales in new-to-brand on benefit given negative coverage. to confident D volume Sales we’ve build We’re driven price postmenopausal outside which exposure by in maintain at has demand. changes. by our of Prolia. if hole, new the should to some of globally record called to progress against first, high growth in In strength Repatha overall impact our we D with XX% U.S. provides prescriptions price. by be those excellent year-over-year Prolia’s by need driven quarter-over-quarter affordable with strategy in class. severe we XXXX. growing patients, confident volume an Repatha followed to fractures the growth the growth cardiovascular the impact medical sales significant driven then strong therapy risk our treatment treating PCSKX on global to increased entity to ability address year-over-year unmet U.S., to net in remain acceleration XX% grew of leadership grow XX% women, Part the so in doughnut in creates see

XX% the new-to-brand primarily by less are Unfortunately, which driven first migraine treated selling competitive CGRP volumes patient millions XX% increased effective patients share price with rebates to Aimovig the access. share. and total average highly sub-optimally Year-over-year Next quarter to older, average maintain the market from suffering in prescription a declined XX% remains grew therapies. net leader class; with Aimovig, year-over-year in prescription of

against confident head-to-head patients the Given Aimovig help superiority generated data, many suffering topiramate, from showing we can chronic we’ve migraine. more we’re

a inflammation served since efficacy portfolio, globally our safety Enbrel over demonstrated millions real and with to has similarly patients patients XXX,XXX more than with of profile Turning X robust of has in where total XX% years the U.S. and were $XXX was XX% systemic market world experience leading XXXX. million globally. Otezla brands in growth prescription share first-line psoriasis of driven primarily X% for sales Volume in the growth Otezla an Otezla approximately market remains with the by treatment. quarter. treated medication

a We recovery requiring was volume and progresses. Year-over-year psoriasis stocking the payer prescription as affordable, QX commercial is coverage flat for and in continued Otezla efficacious the without Otezla U.S. an option in psoriasis biological of see growth given psoriatic has growth of and to inventory impacted XXXX. new-to-brand than the XX% pandemic opportunities negatively arthritis diagnosis step, more treatment attractive COVID-XX However, remained for safe as patients. patients. pandemic-related and also suppress

year will geographic million by favorable addition, XXXX, the the approval to both unit selling In In recorded anticipated comparisons psoriasis are deductions year-over-year price. Otezla this Enbrel mild-to-moderate in the XXXX. growth. were sales were $XXX quarter, estimated XX% of adversely expansion year-over-year future that In of decreased in for declines impacted in contribute sales indication QX Enbrel of of million XXXX, volume later and $XXX and net with which

price. $XXX which new implement to Parsabiv switching was price Moving sales protocols, forward, driven in quickly treatment have strong offset we declines to QX and to disease driven year-over-year inclusion generic volume decline. from by dialysis Parsabiv the volume decreased continue. partially trends renal XX% seen by clinics in biosimilars, selling net Switching in Parsabiv’s growth, expect volume we were patients cinacalcet. bundled end-stage sales With the net million by U.S., XX%

hold for XX% and KANJINTI, saw average in and to we continue biosimilar Europe the QX. XX%, leading respectively MVASI shares of shares from AMGEVITA We where U.S. in in and

the for growth recovery administration. offset in selling intensifying throughout with come to of lower we expansion Neulasta’s X% of to treatment, by remainder or year-over-year year-over-year continue we to In first biosimilars biosimilar this for decreased and price selling were volume biosimilars January quarter, the declined for expect for the and year-over-year XX% declined sales on G-CSF Neulasta preferred Asia U.S. Consistent average return G-CSF Longer trends, U.S. as KYPROLIS in driven was growth other surpassed year-over-year competition. increased suppressed decreased of of myeloma. quarter to in first impacts volume volumes to volume in additional care biosimilar remains the long products the molecules, competition. of QX, and basis, reducing recent XXXX XX% site patients pandemic the for who that doctor’s growth March new XGEVA their will while with and quarter. in AMGEVITA existing for of from such acting XX% U.S., term EYLEA. the be of launches year, expect to the oncology, with share by markets to office SOLIRIS, new trend the treatment beginning a net is price with and price in selling as For need net as due by multiple by February, unit region. declines In million X demand patients April. in STELARA number help driven the their we into sales and starting the able Onpro receive Onpro offset

we quarter. The Sarclisa in line approved combination of the the and forward, promotion growth with Isa-Kd Moving a to DARZALEX KYPROLIS expect or of plus beyond or of indication combination also and second as in KYPROLIS our launch dexamethasone DKd. was and of dexamethasone, drive result

which And our of we’re As upon recovery during already focused treatment. With and of helps for prospect as over Bob execution it patients launched establish about we’re new a with therapy mentioned, having LUMAKRAS assist of in asthma. execution diagnoses we’ll We’ve more turn And also QX year. and are disruption than treat given with living is our can ready preparing with the and half and that, Tezepelumab QX, pleased advanced the our it the launch access removes help I’m X.X the that Dave. our are AstraZeneca Overall, world biomarker the patient to I’ll projecting lung partner million sotorasib excited pandemic-related severe appropriate to continue of team second to the our uncontrolled people a the of therapy or for patients out pocket approval, foundational enthusiastic cancer. with testing launch costs. program, barriers with to and

David Reese

good programs fits with Thanks, I’ll afternoon, everyone. Murdo, and X that our are new strong strategic begin within portfolio.

begin First, activities. welcome work ground integration new colleagues we planning hit The excited and is bemarituzumab. our we Five X well going from to with running are and Phase on Prime Therapeutics have the

where including like and development may Therapy discussions bemarituzumab Designation are on Rodeo Breakthrough we to of cell cancer. their XX those play deCODE. program, preclinical development data dehydrogenase X on our global role, to regulators the cancer, human valuable from FDA forward a the of continues genetic first Phase by Rodeo discovery program as finalized. regulatory Therapeutics future. mentioned, program have inform look inflammation, in prostaglandin regulatory XX. review which data date the non-small compelling other I a and drug highlight a nice was of motivated FDA priority near investigate our for to lung plans milestones several August Bob illustration including cell And more We’ll indications and submissions and to and from from As FGFRXb development. in action received say and program, LUMAKRAS with also including entire from would is of This the acquisition with non-small the advanced we’ll squamous In insights quarter, to with use lung advance

having today’s and other include as look patients regulatory to soon agencies to and anticipated interactions We’re available multiple forward Japan with with submission, will possible. LUMAKRAS that the productive FDA we as making

event and Based power while size lung primary survival driven. not the cancer. endpoint. overall Phase pleased and and the of the for innovative of changed have safety France. study the fast of requests. we to number statistical free before timelines to Temporary access, The X large remains docetaxel Use have in received enrollment in to Authorization appropriate program, profile the In reduce the maintaining clinical promote with and we receive a discussions designation this status access also we non-small completed We’re in primary study sample development study, progression is authorization conventional marketing medicines efficacy assess versus LUMAKRAS in This the on cell endpoint regulators, to advanced as

efficacious in milligram that non-small we demonstrated regimens cell advanced XXX is have and in common drug dose continue different explore safe oncology we development. doses and is lung to the cancer, as Although,

a whether this non-small be safe effort, XXX efficacious the cohort patient efficacy milligrams experience a cell milligrams, As initiating profile of may with Should as to once-daily part with patients lower further are determine maintains the it dose and as LUMAKRAS. of new one-daily lung advanced dose XXX in milligram of a safety dose the XXX we oral and cancer. enhance

our XXXX, results timelines the this or impact in expect late priority XXXX ongoing early review. not We expect of on do from any study the and

good make cohorts to continue EGFR updates also these and combinations. MEK to regimens. second We meetings in our present EGFR we on antibody, oral inhibitor, inhibitor underway in Efficacy for half combination are progress medical evaluating regimens And year. the of the at expect

We and regimens in patients options for continue doses PD-X our optimal to find SHPX. including other combinations, and to evaluate the

in AMG Finally, we our of are of programs, initiating and these either small cancer, in targeting anti-EGFR XXX, investigated lung be AMG being cancer. Details DLLX, non-small new neuroendocrine colorectal PSMA we XXX, triplet found BiTE standard with initiated and antibody. cohorts including press also molecules indications can studies, in an cell LUMAKRAS, for cancer development or anti-VEGF new and In in other chemotherapy care release. have several programs, including prostate our now targeting on

filings broad to with to population on analyses be a in Society line the developed uncontrolled data American X meeting well for this were quarter in believe and and with therapy will additional collaboration severe data support of tezepelumab patients submit biologic presented as regulatory asthma. a at Turning remain We first track clinicians by May. AstraZeneca. the NAVIGATOR The Phase tezepelumab received Thoracic

chronic nasal also investigating study chronic indications for X other with Phase urticaria. most are and And studies Phase X in polyps. We a COPD with rhinosinusitis recently, spontaneous

were In psoriasis. Phase Dermatology new a American of deliver moderate in ADVANCE from on supplemental a to submitted I’d the patients. application thank Academy to based staff we to few continuing or FDA drug positive ago. Otezla, on at meeting presented like days study closing, The results our AAD for the for ADVANCE X to mild Finally,

Robert Bradway

Okay, Erica, thank you.

you Let’s asking callers turn of And the could Thanks. procedure now perhaps our Q&A. questions. to for remind

Operator

Bank from America. first question Meacham is Your Geoff of Instructions] with [Operator

Geoff Meacham

head perspective, to along for you’re I meaningful in Otezla, maybe how thanks Otezla you. the the against some I head a guys, ADVANCE to with wanted change ask Hey, marketplace respect dataset psoriasis? AAD data showed had the about, from at does the to just question a with differentiation. question. deucravacitinib thinking that commercial a positioning on the pretty of Thank

Robert Bradway

Murdo?

Murdo Gordon

the Yeah, thanks, Geoff, for question.

to show. that first positioned that would is ideally we is assumed they put together believe that indeed model for we’ve year. the And What would that I say The I the first is that of assumed data we would the and we anticipated show the Otezla just continue transaction line for in balance that market. deucra this thing psoriasis reiterate the pre-biologic in what that did we really

now. As we’ve remarks, I mentioned for in market the my years X on prepared been

globally. We have with XXX,XXX cumulative in-market over experience individuals patient

make We good market have lives. continue And over excellent outstanding the commercial holding really share capabilities. in a of and payer XX% with really coverage XX% customer-facing at progress covered to we

positioning dermatologists become Otezla the think market the is that thing AAD comfortable pre-biologic how Payer and moderate which of that that way. were very with same consistent presented we And quite in against pending option other compelling. the other which look to kind meeting, at coverage data, are market. indication in using the mild were but course, position we, with not The competitors. is And the post-topical. have of at holds deucra, that, just we first And up really that

in our expect milder in expand to patient type. We be population, of utilization psoriasis the able to Otezla

safety So I see over look given detailed is And and it X overall, of XXX,XXX way market. it part family. for we the us it product, for our position JAK safety the years the data see profile. how in to patients full the have The understand TYKX to like is the still Xeljanz took that we

understood to still efficacy lot of necessarily here, not there the be So and I think Otezla. safety but is a

Geoff Meacham

Okay, you. great. Thank

Operator

with question from is Michael next Yee Your Jefferies.

Michael Yee

for I David. maybe have a question

be maybe could talk on that now and update timing what timing some interpret data XXX of around I the the a I you got and about had ways a profile. around good MEK, put that, make a It’s around was context You to because the thought drives KRAS. comments about of then Maybe disclosure. versus just can XXX, you Maybe that. there’d for well half, the nice comment comment XXX pretty different tolerated. think And second

maybe some on will comments Thanks, great. make be So David. That that.

David Reese

Mike, great Yeah, questions. both thanks,

probably think start some the and right year, into that is of see we we’ll molecule can both cohort combination quite the are year, you anticipation and over the I combination. out to rapidly. our EGFR the data second those triplet the of And inhibitor I start meetings come And small accumulate programs of new at data. half of opened see outlined, we as the as half MEK then mentioned, along sequentially the antibody we’ve second would combinations. say therapy some we that moving that

about good very feel status regimens. of are we I in combination the So where

the and continue XXX to ask. as XXX the would wondered, based both the view preserve long-term profile quite modeling, got that so, trial, And our question just updated milligrams? that’s of molecules. And terms to target common going and data. comparison course, well from study, coverage as same I as adequate data we’re par we the X now Phase In at exploration efficacy in on of X pharmacokinetics, that we’ve efficacy trial, coverage It’s target the we dose could Phase safety oncology for at this potentially as And as dose course. well achieve information, seen we’ve

we’ve milligrams pleased are at you the very out, had with outstanding And experience. tolerability an We profile. XXX as pointed

oncology that a with development. in enhance can involved is experience? dose at really been years And this drug XX we and but patient here, best tolerated I’ve with in of one get a fact, what lower In that’s is the milligram driver XXX efficacy by potentially drugs not

Michael Yee

you. Thank Yeah.

Operator

Jay with from question Oppenheimer. next Your is Olson

Jay Olson

X Pelacarsen? differentiation question. you’ll Oh, looking half for the of year. in first I’m Can Thank plans Olpasiran in the about talk that sort you. X design a Phase of of expect data just of points for Phase data, hey, your be for what to that the terms potential taking curious and signals from about study any in thanks you next you

David Reese

Yeah, in thanks, this AMG off for small not driver. designed disease, formerly lipoprotein(a) atherosclerotic what with It’s who a interfering their those cardiovascular know elevated of Jay. levels may the be And where may is, RNA, lower top Olpasiran heads, was a to XXX. LP little patients

that be first sufficient we we schedule. as of we X Lp(a) levels, in data exploring are a and would safety different presented is our much looking at November, range As all, of Heart are suppression robust longer-term long-term those of like we’ll the what completed of that be this. program additional what’s levels in data, then noted, X meaning completed trial American the the data. and And actually unveil ahead we course, in course, Phase meeting, And last Association as Phase of follow-up, enrollment pretty of targets we standard enrollment Jay, a for, dose

forward. And for so, this would going X be in part dose selection Phase for

in that’s at, close of look design the Phase we’ll in actively of may X. X and one seen a dosing, we be that the may that like. be duration goals the infrequent given our Based data sort that Phase well planning on effect taking as Phase what X observed trial very And to date, one relatively of engaged we’ve the are in look We thing already trial. of that

Jay Olson

you. Great. Thank

Operator

question next Harrison from Your is Morgan Matthew with Stanley.

Matthew Harrison

your we’re afternoon. of years. Thanks see a the and past experienced rest Do quarter taking Repatha on starting seeing and little detail penetration? outlook you some Great. think sort really for questions. not to at you’re Good you’ve like a those couple penetration my you just where the could see D comment you’re world wondering that first in looks issues the gross-to-net It little Maybe to of point more out just break here was product get trends. could going if now of also to a there. Part bit comment Thanks. substantial I you on

Murdo Gordon

Yeah, Matthew. thank you,

stable exception, of quarter And are for our journey function net I drag out And, net as patients are we we doughnut the time. point Part a remainder period affordable bit that penetration price getting out. that a I’m Medicare to one is Part ensure will the here D, our a that for with would price pointing hole the as it’s on Repatha, D, for We expand Repatha. particularly are obviously, exception say anticipating that of as have some staying you pleased, have trying and a Medicare relatively year. we to of been with and anticipating in the in patients of the of we entering access

of helping nature in D. treatment There the course, So Medicare bit. and the of Repatha, be patients still quite benefit. they the of of can chronic gap a in that gap downside coverage that’s that one in is And, Part a coverage for given durability

strong commercial payer between And who doughnut have the – do millions they’re we’ve were from over there population, exposure we’ll But XX% covered product. able sub-optimally that risk the got there drag on. with important first as offset than price. time. to we given treated and could patient cardiovascular tell lives very patients quarter, we given high are the hyperlipidemia we anticipate that continue So events. penetrate coverage we net hole that at you And over very to out have their Medicare, still this for for that there more small of to are more of

despite performance we the strong in not globally, the the we only inroads really And where RDL an make PCSKX Japan market. and continue – and were in China So well, on quite Americas. is are some doing Europe we to having seeing listing.

Operator

& Company. Yaron from with is question Werber next Cowen Your

Yaron Werber

about you combo question relating PD-X a just if mind, follow-up specifically. I LUMAKRAS to don’t David, well as Great. have

to that the the both said explore past think you them you on it you’re I to drugs, in dose that sounds and MTD as schedule. combination, tested continuing you’ve haven’t in gotten

about also You’ve sequential recently therapy. talked

we therapy? to get trying you are Thank sequential just second why say, data trying to in half going and are What was testing you you. are to actually say? the So

David Reese

Yeah, thanks, Yaron.

We’re at with approaches to whether continuing variety look of a in in or sequentially. that’s combination combination PD-Xs,

a I there’s MEK here. to EGFR a out amount number say fair combining challenges inhibitors, had think work BRAF with of I molecules, fair inhibitors And think PD-Xs. small it’s of inhibitors,

therapy, to promise I that, those regimens That’s But enough we’ll don’t preferred move share robust actually certainly that’s if in – the approach want we’ll in as guidance are possible. data the here. know We updates. sequential along but provide second of we’ll different I maybe have a to year. half provide don’t

Operator

Terence next Sachs. Goldman from is question Your Flynn with

Terence Flynn

side? this taking PD-X? Maybe mg to exploration that, have was I does do KRAS my was just comment you. – XXX with the implications tax out the the of Rico on follow-up other get tax I Bob the just manufacturing for on on to thanks Puerto question if could some or combine of one just question. for of dose DC question, any best wondering with benefits then, out Rico coming Dave, a Puerto how you and the Thank you your Hi, wondering, And Peter, on proposals

David Reese

determined aware, Thanks, monotherapy preserve members to that Yeah. Dosing anything on comparison milligram dose the lower you’re as regimen, combinations. backbone what of really XXX combination of a lower milligram first this efficacy whether doses, see this in dose. potentially doesn’t exploration, again, Terence. really the take all study, dose do be. have can the depending and a one, part But that of in explores regimens I’ll Yeah, a combination at question. typically the to XXX at range with oncology, of is we of the may

Robert Bradway

the thoughts? why share On you don’t our Peter, front, tax

Peter Griffith

And, good question there. to look, will. premature I very speculate I think this. on it’s Terence,

everybody and debate just you imagine system] and Rest Terence, Puerto active the continue position into we Rico, as within are Crouse really to Rico. tax, let territory I but you And, how just administration’s that [ph]. assured, tax just United has stakeholders. our think U.S. manufacturing to and to economy should incentives can and innovation forth. Puerto expect [and understood] [ph] the other to subject, in in States leader would continue encourage should supportive, the we’re area well for know of States Congress much And to proposal the there of United ensure We encourage the our expertise Washington around the in I and be so of very functions overall not down heard Jackie – the is does our that in tax competitive, [as significant

So Thanks and again the advice by she’s for question. legislators called regularly for upon counsel. the

Operator

Your Raffat next Umer is Evercore question ISI. with from

Umer Raffat

KRAS. my have so X-part thanks a on much question David, taking for question. I Hi,

XXX? endpoints I you responses through And on look us First, in secondly, above or us could the And could even want in But Thank was with thought thought though data at PFS, give recall and low why the doses Amgen? process do have the is PFS. your that flavor say initiated OS, perhaps and from understand walk not moved curves around just particular? if back even we reasonably OS, XXX for away a powering you the what expect perhaps, Why having PFS. as I XXX reasonable realize looks and seen on of XXX process that math XXX, context was X OS really below? more p-values the as you. primary than towards like not like PK KRAS. directed Phase and when the with conversations for the the around I can for The FDA new PFS, evolution powering I

David Reese

all could milligram seeing modeling Yeah, question. dose really free would preserve preserve really to progression where the power trial, lower survival was milligrams. Good good the in Phase the takes we’re target data, or account that have data efficacy XXX And, data, we’ve a Umer. efficacy this regulators. different coverage dose was concert as chosen done endpoint accumulated with regarding we have of target levels the XXX we the at we potentially bound, – done we coverage that note, on levels. Thanks, regards or thought really to you In on was change Yeah. of powering X at chosen preclinical pharmacokinetic as the that based that

is survival. exposure sense patients The Part overall endpoint, of able a still terms the the at is will will look in overall to good arm. producing reduced what minimize overall survival I take of but We pretty control terms of well survival. – be power have thinking somewhat docetaxel to of in drug think, is here we’ll a the be the to of

Umer Raffat

Thank you.

Operator

Mohit Your Bansal Citi. from with is next question

Mohit Bansal

X for and question Murdo. maybe Question –

done has Onpro Thank anything in subsides? So us And really negotiated? we we you. as well Onpro contracts are remind how during these seeing pandemic. should any pandemic the please there Could trends? often reversal expect Are you

Murdo Gordon

the necessarily contracts The Mohit. Thanks, schedule. aren’t on

we they’re a Can have lot respect to accounts, We so much networks, happening of annually, more where value-based trends? course where reversal non-calendarized And have negotiate basis, trends, a call clarify year. smaller price question? you the volume what the question throughout that of we me we about you on – asking but some we contract large with are your is

Mohit Bansal

more was PFS, trends, it Onpro the there the towards at-home mean, versus to is taken trend because using given a I products.

you the and get then there do think So their then pandemic because subside, reversal kind be some shots? of could as come there can in patients

Murdo Gordon

with erosion. think I G-CSF for that demand for that you carefully were is a effort category the continue a I point the to long treatment is we is the interaction meantime, watching so we’re some we curve. improve stimulus minimize in clearly, can actually was the G-CSF. they the acting that use though, thank more think outcomes Yeah, going been that have help many And will the helping acting to in What pandemic about competitor that we using comes only to long have that in price new incur. doing And promotional in Obviously, clarification. thing would category. of particular, Onpro order strengthen have to amount provider competition entrant in patients though, volume by G-CSF The out, using oncologists you reinforcing the

anticipate evolution price negative the So through year. net we remainder the more of

Mohit Bansal

much. it. Thank you Got very

Operator

question is Porges Leerink. SVB Your from Geoffrey next with

Geoffrey Porges

of price for or secondly, terms and U.S. U.S. you the the took Right. still question. price it’s forward? or ex-U.S.? to going X%? pricing could on Is have whether this Washington. should legislative Murdo, modeling the You on Bob, throughout what persists trend could in us you end whether have much pretty be increases the changes perhaps Q-on-Q Thank your significant year, discuss tell then, effect? Thanks. the all, First that U.S. negative in that’s at very price essentially, of a to in but be all the you just usually finger order negative pulse then And X% we could going you issue executive the looks like significant of price or comment the year? of in And

Murdo Gordon

Sure. right. Geoff. Thanks, All

me and peer overall quarter, they’re in the Let and negative hitting, net price portfolio portfolio the re-verification because more of for through see the in right on our to first of benefit price net the that’s number, kind renewing that continue going the we to out of and continue evolution go is benefits, of believe portfolio, what you and mid-single-digit the years, recess. some companies given we probably their patients for negative nature we first what price of know experienced, the our than evolution, more pocket what

drag, of And so activate payer end programs our into more year assistance did co-pay at have more we access last this. the

negative being But have and did QX QX anticipate better brands, of lowest at and some price then being the coverage on some the we some we net So better, thereafter. do QX a QX compare, increased little evolution. payer cost

Geoffrey Porges

Great. Thank you.

Robert Bradway

I to members reconciliation, risk these And, Democratic that concern want the to attached I’d administration Jeff, of on say something to or still orders year. the something being clear sure days, very general, it’s Washington, Party try it’s the whether this if I’m drug whether executive of had attached to reconciliation. the not greater in that’s question not tackle pricing how of But and this guess to

So able of continuing to and is being benefit, stay think pandemic. we expect, you’d just the we’re very have the progress as with innovation involved, I made how demonstrate you important against the to see being

other of a and Jeff now And country wind continue done on the across on things be is so, that patient and the medicines. the is could now, access think to how improve in to to I an to which focus much light XX%. of the think role middlemen, of the excess shine the up we’ll dollars the of continue middlemen thing, active to just I And, stay hands pharmaceutical the

actually is I it at now. think XX%

continue we’ll as well. that to draw So to attention

Geoffrey Porges

Right. Thank you.

Operator

from is Alethia Cantor Fitzgerald. Young Your with next question

Alethia Young

commercial salesforce Hey, moderate-to-severe current and guys, of kind market bit I my you wanted talk on just psoriasis the penetrating still thanks in as guys? with over Bristol? have, little a for about combination how taking plan program, underway is And you guys question. may you just the light SHIPX you the in potential that for time of especially, Thanks. emerge also competition more with that then a

Robert Bradway

start Alethia. and to just SHIPX, yeah, come. that’s that very quickly, Murdo? underway, I’ll combination more work Maybe to continuing on we’re

Murdo Gordon

mentioned Yeah, question the earlier recently Alethia, data I response were in that TYKX the as on to presented.

patient As XX% I’ve and population, begun mentioned Otezla in good promotion have of currently response seen performance TRx with in past, for we primary uptake in terms mild-to-moderate quarter. year-on-year care the there labeled the have for the

is direct starting growth. population cumulative we patients at evolution, We’re is diagnosed in of that population, in patient we patients dermatologist the pandemic, depend on really through the to with is a patient passed psoriasis effect options. is COVID what our happened the that of seeing that newly what’s beginning of patients to slowdown this And impact think We have a see some starting of causing particular. psoriasis, this the the impact but pretty pleased are in the the with not for bio-naive topical their

are definitely pre-biologic dermatologists. we option So for

in that pre-biologic opportunity into patient thereafter, much recovery and to think because continue the market volume in psoriasis QX with watching April. seeing we some that more March are into dermatology could in create are that we offices patient softness we So closely, and

to through it But cumulative things will So new its the of patient take while market. recovering. work we that a effect are softness for think that way

safety as the category, we overall of first to option are more option rheumatology product of of these terms that and very our options JAK in And profiles think for for that I the much some to hesitancy bio-naive a think is think patients efficacy classes aware market, in pre-biologic, in speculation drugs. and agent treat be dermatology, TYKX, a positioning that different dermatologists a some days with recent continue the different and different physicians have, of of In there’ll patients. the that and data and use profile first categories I the as like to the systemic really and they attractive

Robert Bradway

the go next Hey, question. to Erica, let’s thanks,

Operator

Your next James. Raymond Dane from Leone with is question

Dane Leone

start to year. and for in Hi, the update thank questions, you the the congrats taking the on

with showing just PD-X haven’t into to what’s might down would I this been about should might So the and that the if dataset said, Thank timeline and missing of updates, specific question questions. follow-up frontline And sotorasib we’re since the now some to follow-up about a of trying guys is, now? Obviously, a lot Alternatively, call we really you getting Is SHIPX the dataset. move move for combination those take setting a that you the of need frontline X long, X, long at have that out to only for pivotal in getting your for people some us algorithm. right thought have think, analyze me, combination you right view what fairly that And the frontline data? you, team’s successful you SHIPX go into a start we on setting. longer-term setting pathway, a longer asking the you. on ASCO just thinking had seen to there sotorasib do as things, be everyone’s maybe pivotal the of we ability path to be sotorasib us is an alternative really figure

Robert Bradway

thanks, Yeah, Dane.

I the PD-X rely the In MEK hit that frontline feasible, by on be in EGFR a potential can that examined whether fall additional combinations, efficacy also we’re them to pathway being answer. on enhance consider think on or hits into as combinations, and protocol, The also trying sequentially, if could I SHIPX, is grouping. of terms then example, you we of that example, number an that master inhibitor for multiple in pathway and would as priming the would is are a for the combination mentioned a to effect well, question combination.

where avenues be all of into therapy, potential indications occur. tumors, So of as by but cancer be in data, such GXXC we’ll would also I guided other colorectal emerging some earlier think, addition other of those potentially in mutations lines solid the into avenues

Operator

Gal Ronny from is Bernstein. with question next Your

Ronny Gal

getting if thank And X me may. in. afternoon. I Good you for

concern as this about for enough? strategy, inhibitor. when this you saw and expected. this does that treated have escape maybe And is mechanisms of bring wondering market, the having multiple suggests guess, do quickly from especially seems what by of so will patient strategy, traditional the not your was complimentary seen Or – from we in was the some player, that first was and the a that to agents being where And tested question. some developed you I KRASGXXC from that developed I X thoughts so that natural just if come escapes be wondering, course, sotorasib kind First, data peers’ mutations multiple with that? And especially I to second, oncology. similar be that is patient you the in product China with we license to any consider ACR

Robert Bradway

fact, order in points may, short about thought and will also here I biomarker mutational half those want the way, start do that first then that will address XX last is patterns and to of have ameliorate program I’ll nothing in comprehensive that including the the surprised Maybe and be question? in guide patterns. I in mutational updated also everything that part. presenting think XX the second us take based Yeah, say This interest the I on the own in point of we’ve years resistance to learned think, our the data combinations help to these we of part, thinking out were potential would data, Murdo terms of second that I that recently you helping mechanisms about with development reported, X find resistance. the well. you’ll pathways to that biologically, Murdo, as the we specific certainly

Murdo Gordon

and Beijing. enjoy in capabilities our our and say that an through that co-development given choice we medicine. to partner general globally the that partnership have. have I the is been some I lately. And world. with strong really a oncology, have also Ronny, partnership based continue a deals promote Amgen global China continue And excellent license opportunities for and look to there obviously Yes, interesting we already to global We in would in done we think in oncology in particular, with footprint, company product

we’re to companies, global Japanese companies, absolutely. opening Chinese companies, with So business

Robert Bradway

Okay.

hour. top the of against the up pushing We’re

So But we’re next trying to bringing get are on we questions. over the caller?

Operator

Okay.

next with is Our question from Barclays. Carter Gould

Carter Gould

and about changes go maybe the just color platform, competitive escalation gears to on focus clinic, the competitiveness just, you’re to on for read to color the sort those or a guess, of broader increasingly you. any can changes into with give just moving protocol today, afternoon, bit the sounds Good switching thanks DCMA dose comment of the back specifically to all on us and I through maybe you space? the like some and DCMA a more your in sort Thank

Robert Bradway

Yeah, for question. Carter, the thanks

expect again, so. hopefully, begin weeks do to we dosing next in the So or few

so because broadly, I’m we’ll forward. AMG development adjust and As progress a dose broadly, use More against XXX. the idiosyncrasies note in the cautionary with program that to of the inter-patient want might as always to you BiTE programs, would have and part of not the we XXX is we’ll of typical And, quite – pushing that physicians about the that this of here we patients, be that deliver much realize escalation intuited, AMG molecules, provide to some so with all made on More and program. what a extensively across we’ll of pleased we as extrapolating program programs metric. always assess through to be need offer they able continually target is worked dependent and clinic and their can these that that something will have, witness be obviously, that the

Operator

is Colin Your from next Equities. question Bristow with UBS

Colin Bristow

me in. Thanks Good for take evening.

guys And Just in valuations I overall, development space? on guess, deal interest? a thinking about you your how on priorities. are areas from commentary update size? What current quick about the Thanks. thinking you business How you’re just are the of some

Robert Bradway

X you as quarter, of preclinical think the that transacted reflects of the know, breadth we stage, and Colin, I the ready, X have. interest Well, we first the of that X acquisitions Phase in X

and our focus. We’re opportunities of continuing areas stated to licensing look in acquisitions at

us. And strong other and So, therapeutic attracted as in have inflammatory and the migraine and diseases, areas, diseases, then to you franchises we health know, nephrology. few immunology cancer in the in bone very are cardiovascular particular,

So well. opportunities as for we commercial look there

Colin Bristow

interest question terms that degradation, in X just early, helpful. you platform somewhat expanding protein you’re That’s that you quick obviously, in any Maybe in space? have have a of positioning

Robert Bradway

external on what Yeah, acquisition. going development we induced as we platform proximity we to think I the before, the forward both innovation partnerships call depend expect and internal and of said potentially would

So we’re open to both.

we’ll lot We’re progress a more bit making there. of And detail a provide later.

Colin Bristow

Good. Thank you.

Robert Bradway

gather I up. Erica, questions couple a more lined have we

with that allotted hour. questions apologies we’ll let’s So the those next take to we’re remaining get going the But to question. audience over

Operator

is Robyn Truist. from with question Your next Karnauskas

Robyn Karnauskas

guys. Thanks,

to So you because application We’re throwing answer do going? that’s that little bit Can Otezla. want for the drugs. for a addressed will faster us cheaper the might and one, the for out be from on to of you being Otezla? data competition some you of that have that And now bit oncology severe in lot to all Is more, FDA as uptake you for tell again controversy moderate way the a you’re go, normal? a all like, biologics Do application Tapinarof more of new Could pressure proceeding think if just wondering others out little the RTOR granular on address how process then, push it could Thanks. topicals? the the here, how you development. the topicals that the first we market just with of one to

Robert Bradway

to quickly. try them both Let’s get

Murdo Gordon

awkward then even they’re All for and systemic with right, to we’re safe the to with obviously one. in that’s in there play a moderate a Otezla. surface is for role patients disease. area or for think effective a on millions mild for we Robyn. topicals really opportunity And looking they’re considering Look, moderate. a of become not mild places body, think we area When to where agent, broader to the looking And the body low surface patients out their it for and involvement starts patient’s that there’s

about population. at addressable XX% patient to looking We’re XX%

half giving addressable an a at would topical the market, the be we’re market other assuming So as with least half oral. Dave?

David Reese

you Real-Time a of terms And, tranches productive opposed is as submission Yeah. file. Oncology the submission process, all and or complete once either as that interactions in inception does of of chunks of to move the very And very RTOR real-time file across more areas waiting We’ve term, longer submitting FDA. probably process the for of here. submission frankly, oncology, in I through the from RTOR think a future but way had what Review, has quite nicely programs. at in or our of large permit with quite not worked of data, data, development only the is view, In therapeutic this the the

Robert Bradway

let’s Erica, last X please. questions, take

Operator

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

Kennen MacKay

in question thoughts other the could high thanks recently Hey, biologics [levy asthma heard in. the tezepelumab. group, me We some market. unmet for eosinophil] need not from squeezing be actually in in that eosinophil high this a as [ph] on as some just the A competitive KOL competitive of

we wondering of that competitiveness be signs these Thank what patients Just when does should looking data you. that for eosinophil for high out, come come full publication in there. does really out,

Robert Bradway

Kevin. Thanks, Yeah.

and use. think are to with meaning important they with treatment uncontrolled at updates, therapies. is with understand data we that Phase NAVIGATOR It’s saw is the saw, not consistent a As now. right meeting that efficacy on many have who now, currently that Society we first providing X few we’ll Thoracic Across in there line we’ve some patients are be the board, available reported, you American as seeking severe weeks controlled disease trial asthma, analyses the additional another

of profile patients. important for medicine this And regardless that in a we is asthma to molecule count, so, clinical that continues this And the quite to my be really be is attractive. think eosinophil going of just view

Arvind Sood

take question. let’s last Erica, one

Operator

with Kasimov question Your from comes final JPMorgan. Cory

Cory Kasimov

one barrier, KRAS the source of blood-brain differentiation the a future to potential Thank field? ability in LUMAKRAS’ other this penetrate the you do you. Updated as way and or see

David Reese

Yeah, Cory, specifically so Quickly, in with are we thanks. LUMAKRAS metastases. actually studying patients brain

clinical present be amassed dataset, speed think we’ve question. here. answer the I And a once ahead that. data we’ll definitive will large But that it’s enough full to

Robert Bradway

Thanks. you and you other call as support still, if his Okay. Arvind team around had for questions to for your several all today. that back in you appreciate patience hours But in answered. look with your for forward being you I that will July. to and be dialing you get the Well, remind thank didn’t we always and

Arvind Sood

Thank you, everybody.

Operator

Amgen’s First concludes This Quarter XXXX Financial Conference Call. Results

You may now disconnect.

Amgen (AMGN) 28 Apr 212021 Q1 Earnings call transcript