AMGN - Earnings call transcript Q2 2021

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Operator

Is Erica and I will be your conference facilitator today for Amgen's Second 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. In order to make sure 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] 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 reminder our smart themes execution key are measures so think X the in in. right for will development. to challenging Slides use pipeline let's financial jump business A in environment, quarter we advancement, presentation. strategic and quick and up. Lots cover, that a great are non-GAAP

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

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

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

Bob Bradway

Okay. while thank revenues well, lingering many the competition execute future prior Thank our over XX% in paving second year, for quarter also the Amgen you, this first Arvind. of the for the increased Through therapeutic to effects globally, from And COVID-XX over continued driving products. in hello growth the the increased prior way of X% growth our demand year, everyone despite call. the categories. has you and for and achieved X quarter. our We of months products Total joining current and

medicines of continue oncology Prolia, and number Repatha, see biosimilar strong Otezla, significant We and of a -- volume-driven from EVENITY, which all to growth as oncology address challenges. well, our health

the stated squarely FDA complement several we've first efforts ready belief quarter for approval the our our partner approval X excited region, Kyprolis, The for to And the in year, second our millions two oncology categories should the moving us quarter we're by another affects to Five currently areas interest. assets forward. States sought United advantages that best saw to China, world. and external of that the milestone collaboration particularly [Indiscernible], important [Indiscernible] example, the this We the further and around with growth added treatment development there. our we're review our half where joins offers Prime that We've the We people our and long potential of have growth In for U.S., to growth market. therapeutic available compelling in Beijing biosimilars, migraines partnership Therapeutics Aimovig for internal asthma, XX% to to the enthusiasm disease Tezepelumab, first-in-class cancer marks LUMAKRAS alternatives the of priority which We're granted outside that approvals also acquisition notable in treatment provide inflammation systems healthcare confirming a address oncology Japan, deliver need. [Indiscernible] the from The in Very generated over executed capabilities in has high innovation encouraged by will innovation. engineering secured strong Dave patients a And areas. the it for the with in there in community. severe LUMAKRAS, supporting of available unmet debilitating a remains in worldwide. need our value hope our Teneobio, generated therapeutic of across commitment to also and moment, is our of strengthen options. which acquisition of pleased in fit business will significantly launch volume which new where with transactions significant protein which of our with phase progress in in additional strong providing excited lung Asia-Pacific in cancer In

a facing we to many address way to sheet focused All advancing do development us the helps and will so cash business society. work serve on as these, that balance of flows take strong they enable our do is additional challenges the mission like to to patients Our opportunities, arise. and advantage in

also other and facilities, one more be utilize are million very from a we, of friendly in large next hiring plans talent with as cutting-edge to Ohio, OneTen efficient our supporting build Both and well-paying You meet along the our diverse to Americans goal demand neutrality will other two XXXX. achieving of over to XX announced number by $X part approximately North invest much look may collectively of recently manufacturing to pools technologies plants environmentally companies the draw facilities have seen traditional new carbon coalition, to into will that years. the medicines. than billion the Carolina, for we Both Black X in jobs plants,

of about our report, to commitment good more be by the citizenship which our ESG Amgen.com. Section corporate learn can reading You in responsibility. can found

colleagues Murdo, let over across to Finally, you. delivering Amgen business. continued world strong and turn before commitment patients our all around my of their me to aspects the thank I Murdo, for things serving over to performance

Murdo Gordon

Bob. you, Thank

product and Second-quarter Repatha, year-over-year by X% Volumes increased of increased double-digit our Prolia, products, growth MVASI KANJITI. driven a number including biosimilar our across sales X%, and products,

ex Our year-over-year. - XX% a U.S. XX% volume grew with growth business of

remain compared from when QX QX Patient impacts to COVID-XX and XX% Face-to-face the continue recovery remain but customer test the trends continue are interactions increasing pre-COVID customer pandemic We below gradual Overall, visits see pre-COVID improved U.S. and accounted of to of second to procedure lab quarter. improve We execution. XXXX. a in activity activity XX the XX% levels. - focused levels. during for field on quarter-over-quarter of reaching

expect the business cumulative new decline which of starting course suppressed volume the in half to patients the continue diagnoses year. during of of the the the second impact Over will we treatment, pandemic, has our

rates revenue XX% and drive are approximately Prolia U.S. growth. to remain driving and focused review an 's with driven unique year-over-year trends will We patient health by remained second year-over-year, driven second on optimistic growth the driven The sales innovative Now the by acceleration XX% growth year-over-year, saw year. our let bone demand product doubled patients. half of of new the beginning entity increased attributes in some in nearly and In believe volume at as We we osteoporosis continuing by growth. volume bone-building XX% levels. sales continue EVENITY In strength about Prolia's me portfolio. primarily increased pre-pandemic XX% details quarter, diagnoses

Moving And and growth. in to we And net by increased U.S., patients by In year-over-year, coverage the year-over-year. since share class. reached was partially price year-over-year. receiving U.S. leadership offset resulting the from than more XX% sales D X volumes U.S., selling volumes Repatha, XX% Repatha lower the quarter the launch. total growth maintain outside increase XX% Medicare the grew which volume has XX% million patients driven and Volume in PCSKX Repatha entering grew Part gap. an in global

forward, some developing or a Looking a help stroke. to attack to net risk reduction selling global sequential confident grow our patients at on heart of in Repatha a in ability expect price we're basis. Overall, ongoing we more

selling prescription XX% year-on-year, Volumes which and to brand year-over-year total Now grew grew a but than and by sales deductions onto were net Aimovig, On sales estimated basis, In lower changes grew maintained quarter-over-quarter. U.S., among the net declining offset CGRPs. XX% subcutaneous the X% share Aimovig volume unfavorable price XX%. leadership TRx more

for topiramate. the published in patients date, Aimovig Aimovig. see than clinical ahead, market. more many Looking will versus data continued million more half chronic we significant worldwide To s patients have a rebate a to help pressure migraine, believe suffering Aimovig given We be from CGRP superiority potential share prescribed oral showing soon, has the that compete as been

and U.S., sales inflammation sales the lower unfavorable by share portfolio, $XXX changes to net offset deductions selling the Otezla in Moving than X% first-line with to quarter, psoriasis. price. in Otezla million volume estimated more In leadership were our maintained growth

in New-to-brand grew was lower treatment a prescription for gains The offset near started remained dermatologists year-over-year, even patient who levels. prescription rates prescription largely as by QX volumes of patients below to Otezla with and number XX% new levels, pre-pandemic visits those pre-pandemic XX-day but fills lower percentage XX% Otezla. refill of were

the progress dermatology segment We quarters. in expect coming [Indiscernible] the will over

decreased anticipated by efficacy in in for X% estimated selling net the long volumes the X% preparing by mild-to-moderate later track safety. approval we're deductions. declined of basis, U.S. a of the year, ENBREL indication launch and year-over-year, forward, primarily driven China. supported On year-over-year prices Otezla by for and record ENBREL's of lower sales Looking this the psoriasis sales

partially volume million in by growth, QX which by was price. biosimilars, to $XXX selling sales Turning declines were strong offset driven net

to for the shares continue biosimilar in AMGEVITA, KANJITI. U.S. and and for leading We in hold Europe MVASI

declined we declines to and price markets a selling new increased from price of in year-over-year quarter. the volume and XX% and preferred Longer-term selling such lower due by Neulasta the favorable the XX% growth come from This remainder additional in expect Neulasta's XX% year, Soliris, by in existing Sales average Amgevita year-over-year, by U.S. net STELARA, reimbursement year-over-year a in in and Onpro growth biosimilars price share $XX remains biosimilar mix. launches competition. oncology, EYLEA. and offset was molecules, partially volume million the GCSF net lower be biosimilar U.S. to will for long-acting the products In quarter-over-quarter. driven selling volume. worldwide of biosimilars offset the with benefit changes of For the expansion declined as XX%

We will year-over-year, competition. throughout expect increased volume intensifying price. driven by this XX% XXXX, KYPROLIS selling primarily trend sales and driven growth net continue by

will pleased patients the this off from growth access Overall, points COVID-XX with medicine. them maintain And actionable given which I with on I'd Dave. launch. on strong the And GXXC opportunity of from with oncology to be increasing labs during our stands can I'm that, continue cell would closely and focus cancer benefit. in pandemic and with KYPROLIS the year, XX including can combination brand a XX our monitor in the business, in now and take patients XX%. metastatic medicines to breakthrough comment to they use is unaided non-small its expect now behavior like launch patients we testing the antibodies, turn the course our will the [Indiscernible], forward, recent to half our working ensure positive it KRAS laboratory. on start of ensure impact KRAS to sustained with to execution top reaction of over who impact and We're to reach the QX the since XX of at execution their of on patients as Moving very community, I benefit with physician CDXX lung testing closely for this with pleased DARZALEX second our from awareness identify

David Reese

medicines Murdo. illnesses. I to Thanks, begin developing acquisition. Teneobio, engineered with will in quarter. important made several components in R&D afternoon, leadership three protein-based good Amgen's with acquisition our advances which There strengthen the treat will last to serious We are patients And important of everyone.

small can and a of will be soluble, development stable, to domains in easily biologics express multi-specific these modified capabilities Teneobio's from to range heavy and complementary of generate together our multispecific It string antibody comprising key a molecules. are a beads antigen-binding single-chain BH A wide targets offers strung to directed IgG on only molecules therapeutic chain, human [Indiscernible]. core like First, molecules against technology antibody platform the diseases Tenebio's across our enable is genetically areas.

In a availability addition, Teneobio of and broaden platform. to engaging also domain, technology of our the the allow enable will second brings affinity target. on engager CDX a The that us novel customization depending engaging bi-specifics CDX and capabilities disease T-Cell our BiTE complements lower

clinical programs antibody by acquiring was validation. and of These PSMA designation AMG selected Acapatamab steep high-value which XXX fast-track own target which based and interest, that XXX, and also we're X oncology bispecific FDA. one on granted cancer efforts amg Finally, targeting include targeting pre-clinical recently are specifically we against for the directed prostate discovery complements targets our Phase a

experience from including oncology, Europe who LUMAKRAS globe, excited with LUMAKRAS ESMO positive. have been personally that been and programs. LUMAKRAS will on submitted abstracts metastases. [Indiscernible] LUMAKRAS have Revolution EGFR as have reviews World the Advance Updates and heard the trial. the through our across entered GXXC metastases, medical for I'm launched cell report lung into KRAS with cancer. Novartis Medicines, in in advance oral with including early non-small the to fourth SHPX the presentation and combination our received around with our collaboration SHPX cancer overwhelmingly collaboration been continue and a broad-based development to accepted To for Vectibix we data data XXX expand access colorectal Initial combination and biomarker the mutations. MEK combination has quarter. the the lung have available global have to XXX LUMAKRAS we for are investigators in our monotherapy, Recall along for a study, brain to treating jurisdictions, medical patients than stable investigating our U.S. as and for accepted I've Feedback physicians, X,XXX in in efforts. September also LUMAKRAS well LUMAKRAS at and program, active heavily with Congress our to their sites, cancer progress continue additional with more we our regulatory also meeting we patients or in patients Japan. pleased on oncologists registration multiple from that presentation in to are combination Turning patients screening analyses, are than at more from ongoing including brain from community In be

the other We checkpoint initiate a This in study Bemarituzumab X investigating program the addition will II PD-LX utility of also a phases tumors the cell mutant registration are cancer to Phase third plan quarter. program, And the we initiating STKXX with year-end. negative development path non-small three Bemarituzumab evaluating In and cancer include the good and trials. with Bemarituzumab discussions first-line in on with on patients by the in lung having plan inhibitor. Phase to of regulators chemotherapy. and gastric combination or the two chemotherapy One

also potentially AMG are study XXX. II planning Phase pivotal [Indiscernible], to with We

to extended cancer. pleased to half-life small regulators steps for or cell dermatology, report we targeting we in to expansion we I castrate-resistant look Kirin cohort In molecule for And with known the to meeting [Indiscernible] Phase also X the presentation the weeks. discussing into KHKXXXX, as at Our working DLLX look closely well coming AMG of next dermatitis the the BiTE our enrollment development discussions in first-in-class as prostate atopic am the also have XXX, that lung We atopic coming inflammation, AMG OXXX are forward in continuing with completed initiating months. leadership annual dermatitis. XXX. the cancer the September, of of Kyowa X a at antibody Phase Dermatology in of data for and regulators Phase the Venereology X as, with European end our on forward plans advance Academy

Otezla for the mild-to-moderate In FDA psoriasis. accepted supplemental addition, the filing

In priority for to entire our I the continuing and treatment review for to pleased patients. the organization for medicines we're the asthma, Peter? unmet need. FDA closing. we that Tezepelumab reflecting would Finally, significant like of AstraZeneca, very partners, granted medical important advance thank our

Peter Griffith

everyone. our guidance. Dave. discussing XXXX Thank financial And through you, I good day, results briefly will before second-quarter walk

both delivered The another in as non-GAAP X%, increased period grew investment second of internal performance volumes and external year-over-year we marked EPS quarter X% and solid growth. innovation,

shipments XX% to Lilly. As QX earlier, million increased Other COVID primarily driven revenues of antibody X% X.X the stated at XXX year-over-year, billion XX increased year-over-year. revenues therapy by at

to range X.X billion. We continue to to of be X.X the expect full-year billion XXXX other in revenues

and The investments to second non-GAAP quarter's shareholder increased expenses value. XX% as year-over-year operating we continue make to maximize drive growth

million Rodeo, We absolute $XXX [Indiscernible] on expect the X% of including full-year basis to to also and expenses, X% expenses year. and operating increase collaboration last operating about Prime, related Five acquisitions, to to over approximately the an Teneobio

Lilly, to X.X% basis, well share a as and as of basis XX.X%, driven delivering the full-year royalties. to mix, sales of including year-over-year While by sales a profit shipments COVID-XX XX%. of margin non-GAAP cost roughly primarily a operating On percent antibody increased on product product a points as,

sales cost the sales expect percent product full XX%. the we the to year, as to XX% of to continue of be For

increased payments Our and increased. royalties cost of as sales products product have share has share, with profit

part to a launch. investments research. As Evenity royalties spending of few XX% at profit-sharing biosimilars upon MVASI, Prime and increased acquired a our increased KANJINTI. and Aimovig in as year-over-year subject Those due as are products of discovery acquisition reminder, QX and Five Non-GAAP approval are [Indiscernible] RIABNI, subject such arrangements in to investments and R&D tezepelumab to in the

we early year, programs. We'll the to R&D late-stage and progress continue increase full spend. innovative non-GAAP our For as we expect pipeline

Beijing a expenses quarter Non-GAAP year-over-year year, BeiGene connection to of other arrears. and by non-GAAP portion collaboration agreement. to favorable Beijing due the million full one in basis, which our income the reflect record primarily $XXX payment decline. a results 's with we were we spend expect SG&A results, on For QX in received upfront

and with expect expect X.X QX in We and billion. our billion of income expense and our range to QX X.X QX in to range more be other non-GAAP full-year the net expense

the and Now, market range EPS are of investment collaboration. the XX.X pipeline. XX.X United still the test by lab to the have operating levels. pre-COVID-XX development to for our $XX. is our half year. guidance business below underlying Notwithstanding to dynamics to emerging Based in of are on continue visits balanced variance roughly $XX These uncertainty augmented Patient absorbing continuing million. that This $XXX and improve, above XXXX. business business turning we Rodeo, including by innovation expenses Kyowa the reaffirming we the related to and outlook XXXX And guidance billion but reflect development procedure Kirin related year revenue trends our activities, announced mentioned for the billion. Prime, in our States excited range remain and of Teneobio, this second Five we ranges plans, to non-GAAP

XX.X%. unchanged non-GAAP tax remains guidance Our rate to at XX.X%

Our capital our and footprint. expenditure digital continue and business, guidance in investments our manufacturing their technologies including environmental our $XXX increasing reflect million Investments throughout at remains improving related capital unchanged facilities, expenditures investments. and in to ESG our

repurchases We billion for to over range upper financial the XXXX of it expect for to $X to I'll Q&A. billion. This update. $X concludes Bob turn in be share the

Bob Bradway

opportunity feel Maybe question questions X mind so open ask you birthday a us. like sure for to let's And callers procedure for ask Erica, a them you bear of everybody our Arvind's here [Indiscernible] when our know we it's who that has to desire and today, this Okay. afternoon. question in could I ask us would our to that callers so of the to that of get remind have lines the through the questions.

up. Okay. Erica, open them

Operator

is the first with compile roster. Yaron we while Werber question Cowen And and [Operator Instructions] Please Q&A stand from Company. by your

Gabe Daoud

GXXC quarter. what that head-to-head what on on my you on discussions Gabe first-line low you comparison your arms guess you. and your with question is for Thanks for just historical focused use XX. past, co-mutants taking lung about LUMAKRAS be and like, and Thank the on Could study the, the cancer need the you regulators? mentioned what benchmarks in Yaron. can comparisons and look would with those future reference as Hi. and/or question and be. for there the in updates patients there This in STKXX My PD-LX would studies the STK a for any is your In could congratulations I talk in the

David Reese

Thanks, Dave.

as So, be there's Our cell out, patients of conducted think are will we really, XX course, where benefit negative of in checkpoint from need. this patients, cancer or you as a in medical STK we who a -- unmet mentioned, study non-small lung first-line pointed either populations PD-LX of who inhibitors, patients don't who lot typically of residual

STK mutational checkpoint XX In to resistance help fact, inhibition. confer status may

So FDA trials. Whether this wish they cancer, population is too been be registration potentially not, we're or that The it's has to I targeting. see lung that to can first-line in that clear early speculate. generally the think enabling randomized

So, data, anticipate if registration have we X based single-arm we pretty saw on to going conversations readout forward. one would compelling efficacy lead -- Obvious would to having to the spectacular a trial. Phase appropriate a have

Okay.

the question. For next

Operator

with question Raffat Umer Your Evercore from next is ISI.

Umer Raffat

age Hi really my question. for today. wanted to guys, I taking focus on just thanks Arvind's

Bob Bradway

You and me both.

Arvind Sood

Turned XX.

Bob Bradway

what both. me can and for you? right, we All do You

Umer Raffat

was My really there's question any. [Indiscernible] whether and on today Congratulations. around the

you study, upset negative well X for or there of is negative the particular. XX. trial as PD-LX ongoing first-line the very to any to you X plan in Phase PD-LX remind quite for STK phase limited whether intrigued I'm that If limited primary as informers could Thank much. the analysis just is the us

David Reese

Yes.

the In falls in to best X lung to [Indiscernible] that data rapidity not next be after third utility historically standard general of is the patients second we line, the very first analysis think trial, of analysis. and interim often progression cancer year. useful, therapy. about meaning The quickly the an then particularly given that, Umer, may expect And I half analysis of of primary of Phase the way in terms think

the and rates. first at as So, year really that in a sense the analysis of And half the I a year negative currently refractoriness in a would of said, half and/or those event But the of next need look the primary of major STKXX first-line, course, in given the significant I second take the event. mutant as the medical available of we'll think then in get to tumors, point STKXX PD-LX relative X unmet there we population, treatments. is that mutant better

guidance is forward so, enrollment to soon data And that on underway. on as seeing looking provide much we're study shortly in getting very the launched readout. really timelines We'll as

Umer Raffat

Thank you.

Arvind Sood

Erica?

Operator

question Jay is Oppenheimer. next from Olson Your with

Jay Olson

lung questions. should cancer Arvind. curious of Hey, incremental expect LUMAKRAS be for And about the you data with for to comment we only thank so happy that colorectal non-small combination you. data that, combination taking the Vectibix? much related in you cell see Will I'm combination use that cancer? potential to to the or of data And on birthday, can in Thank Vectibix. drive

David Reese

Jay. Thanks,

given the that Given have colorectal most of on on regimen expect Vectibix across have Vectibix enrolled physicians that they that enroll treating we're be appropriate. patients you been the feel may & to is cancer, can although that if patients regimen backbone the LUMAKRAS particular here, for open malignancies trial of that will the studying, combination

of In speculate Vectibix, to of don't I on uptake terms that. want driving

and if cancer. really we can is in see generate combination we data, particularly to here colorectal drive think job -- these really Our forward, things

Operator

Mizuho. Your Syed is with next Salim question from

Salim Syed

for I and question, Thanks the my guys Great. Arvind. so and you Birthday, both Happy are I'll much add XX.

on So, tax petition. wanted the focus can. I just I If to

of and this just was notice years; like XXXX. but was deficiency seems it X year, X for not for XXXX, So, it XXXX,

is the here So, there are you and And you. of when pattern expecting? XXXX be through interest what [Indiscernible] curious Thank or for the then should here. that are how I here notice guess the And posing guys accounting 'XX. the the curious underlying just just doing is what is IRS I deficiencies. I'm triggering this deficiency and a question we noticed rate

Peter Griffith

territory transfer these the regarding allocations to your profits the a IRS the and between of on the notices dispute It's matter, the are you. around pricing the thank dispute. the Rico. And Look, U.S. question Peter. of with Salim, Puerto related IRS

Salim a on I manufacturing. So, colleagues several would facility, the years merit, to without with like you will take the Rico resolve. had we of flagship Amgen's of in can and facility. is very our a strongly see value significant note tax Rico that reserves. Rico Rico performed Puerto We've Puerto for of we with dispute activities have our appropriate operations, the of We we IRS' And responsible our opinion have the undertake complexity majority difference believe Puerto to and is our this position manufacturing years. the them, We're proud global XX and there. of Puerto for proud about major manufacturing presence risks

very than those and employers. nearly We've to We and in facilities Puerto invested more of best billion Rico. most expand Puerto responsible patients the world modernize all be we're sophisticated serious Rico, $X island's as biologic highly produce recognized And diseases. colleagues XXXX in over have consistently to the one who with for medicines and skilled proud

for the matter in rate, to the but that's interest I'll IRS on So, of refer to matter have that, brief. IRS you the

Salim Syed

Okay. much. Thanks so

Operator

next question Sachs. Terence from Goldman Your with Flynn is

Terence Flynn

Thank you. how noticed here, much that question. you're year going margin's for this should called to of longer the newer forward? just are royalty can Maybe splits one launching. products comment the so I another margin XX% we given operating Great, the about But you be and think the profit and cadence increasing some term. on that if wondering on taking the thanks was out you for Peter. I

Peter Griffith

about specific like don't give OpEx margin rates. what versus Northstar And, to enterprise guidance. for long-term we as thank to think we targeting around always, after-tax you. cash operating flows I'd or say, our this, and Terence, objective always pause our is growth But grow margin the our really

to to So, that continue make prudent investments to objective. that we're going lead

continuing just we're So, external would I in note, internal, to invest innovation.

products, that the launches the second You've of efforts. fruits new seen quarter, broader digitalization the of in

our three Phase as in highlighted are and AMG dose-expansion, have those Phase [Indiscernible] cell the we rapidly we expenses prostate our assets AMG Do and we R&D grow advance going cancer. to we're biosimilars going in increase small three II. expectation Secondly, XXX year-over-year lung that in spend XXX in on III, to

Terence as in and the recently with just Kyowa we which to cost announced acquisition. Prime do Five acquisition well Rodeo, XXXX. the as expect to upfront note our I'll related Third, costs collaboration our second the acquisition the we're absorbing half of close that Kirin, of the of recent of Teneobio, the

to rapidly in these progress bema being development costs the began to COVID as molecules depressed ready related the in the KHKXXXX. But effort. of QX higher due plan comparing the QX. Lilly Net year-over-year and on for also remember, Phase X were We We antibody manufacturing QX Those COVID. a adds two. basis, the rest we're OpEx and in or of year build XXXX to spend to

we and that day, the expect top want end any that really metrics the pride number up end So, and to knowing the we analysts, at terms of efficiency. in financial measured our our in to there's at of of the we take group be on of by investors the operating and

So us. important that's to very

on So, continue stay to that. you assured can rest focused we'll that

Operator

from is Matthew question next Stanley. Your Morgan Harrison with

Matthew Harrison

but it IL-X for asset? see comment X mutein. end I Xb data Thanks to year, Phase what could I like of also going here Phase think some towards to profile we're just competitive a was for you the on and taking looks afternoon. Good on questions. Great. at and wondering you've started maybe generate on broadly that have to need you're looking just the the if be SLE you the you UC, know the of the Dave,

David Reese

brought our I'm XXX, Matt. up mutein. Yeah, IL-X AMG you glad thanks,

this out autoimmune diseases, some regulatory modulatory the key in number designed many everyone, of remind a to to molecule whack. T cells the the of the and immune Just enhance regulatory system. cells, is function T of access In is

-- anticipate you. with to Xb end year. data data able Phase being you medical meeting at And look sharing we we'll those forward towards of As there lupus a the in the mentioned, share

dysregulation a really which readouts now. addition, bit II disorder, the that of will accrue be is lupus And a we study are autoimmune it's colitis, of Phase X we there's in of enrolling quite Phase as data. trial as another ulcerative actively critical a In finally, think in evidence So I the in here then mentioned, launching [Indiscernible] Matt, those you

standardly active make always, the medical long-term patient drug lupus, an only need. large As with what to is unmet is for that to or a particularly two, look approval population, second adding XX last In within very something needs. There requiring ulcerative available. an we'll remission but unmet we also years course, are they're area very medical a colitis substantial in a was and sure the day large are there residual remains of still medicines

speed full IL-X forward with in program. data this sharing ahead the you. mutein it's We'll look to So,

Operator

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

Geoff Meacham

Afternoon happy Murdo. for Otezla question for question guys. on birthday, Arvind. Thanks the Commercial and

growth any year, how And the COVID competition a to was versus, population? so, when first do the when And you mild you in headwinds moderate of half much or impact look say, pricing? launch factor of of think upcoming at you at look the the disease-patient could the you. Thank this these

Murdo Gordon:

saw biologics And would the each market psoriasis number patient slowdown treatment last the would the growth in to psoriasis, by from we on COVID of visits. that, the Yes. and Geoff, Thanks, that say given patients from say option throughout gain of moving in than based a which course an to we the I of bio-naive tend I year, into is Otezla impacted Otezla were early other. disruption more

news this diagnoses new growth up. The is of our tick in slowdown year. patient compounds year last patient the new quarter saw trends we the good So that rate

new growth patients, see prescriptions in did quarter. we new-to-brand prescribed So, XX% in the

that And There increase an the from pent-up that by offset switched we that decision-making of usually dermatologists patients was of somewhat didn't indication going starting. was patients that's year. their our in that mostly some last new to price related away another treatment were to Otezla this co-pay a weren't but to treatment. programs, good see number However, reductions think patients because happen

share come continue So, we should overall, mild-to-moderate sure pending the continue in growth feel would has in respect What optimistic coming to the I COVID other answer well. by psoriasis of which that that. share Otezla not like continue our is we bio-naive impact. held hopefully to and I this I'm patients, execute it's share about given say to products can how the of With Teams of our to year. end say indication the position, primarily to in, patients,

long remarks, Our we to field grow we're And on over very the sure my mentioned is I Otezla as haul. improving. opening continue execution, making in focused

Geoff Meacham

Great. Thank you.

Operator

question Gal Ronny Bernstein. next is with Your from

Ronny Gal

question. Hi. And you taking my thank Good for afternoon.

Let's start with the immunology team here.

You and a long-term developing sides of STELARA in both world, the be you guys wondering a if I given the for innovation are to biosimilars. both you similar trajectory And going in had numbers, thought should specific XXXX begin [Indiscernible] see -- diabetes XXXX's market giving markets. pricing was see It's of about the That is, immunology this how price we we about along the long like think to of with do ongoing you term? do lines you something what decreases. without gradual with

Bob Bradway

[Indiscernible]? to want you do Murdo,

Murdo Gordon:

to of mechanisms, competition that the now, secure Thanks seeing to and pay Sure. held in a after lot We're the far. management go gross-to-nets, for get therapy. being new hesitant PBMs a a as lot large mechanisms is new a right inflammation is lot patients versus in seeing, Ronny. question, are increased lines placed to I'm and out to which fail of What of new there of of we too the which [Indiscernible] earlier increasing. by reserve course, national entrants, in formularies national preferred access. status have also of

both we're the and some increase. parent think will in line to arthritis themselves symptoms and improve given biosimilars seeing perhaps of the accelerate novel providers, continuing have we're biosimilar with of TNS do molecule penetration trends failed and early see disease. from interest after will rheumatoid example, that now with I dynamics, as the the PBMs, I the that think of increase interest in entrench or entrant. resolution second that take think I biosimilars we their originator that third if or in And in And progression their do to biosimilar to an be and mechanisms In are position, first-line payers, a the in the RA category. patients new seeing of inflammation even So, I the molecule have likely

just So, we a given the [Indiscernible] time Company to overall, I on the that would that the condition our the we're have enhanced AMGEVITA the portfolio U.S. be expecting molecules innovator originator as In we strength come to But back of by or serve as our of to lot payors, of providers, a biosimilar presence of portfolio. value healthcare patients system. a the launch diseases, that as to and across think with host I autoimmune well with And serve many an affords opportunity the us -- to PBMs deliver

Operator

from question SVB with is Leerink. next Your Geoffrey Porges

Geoffrey Porges

the continue you much with Thank very question. guidance. for biosimilar you. the I'll Thank taking

to terms would trajectory And you for excuse a be of what brand the or example, trajectory also to and XGEVA gradual, is just you me. the of [Indiscernible] biologics thinking the think Specifically, first it wondering would so of you coming on will what an are the expect to, expect or you the in like? or similar look for be in which more biosimilar oncology Prolia then for Denosumab, faster erosion erosion

Murdo Gordon:

payors it's Thanks future Geoffrey, I their would the product, the say, B healthcare oncology a defining for. as change curves in we to the biosimilars. of adoption think be again, question. and project I But to into close Part the for hard that system's how given a would what biosimilar Denosumab of approximation providers is will

Operator

is next Jefferies. from with Your question Yee Michael

Michael Yee

on have [Indiscernible] for Thanks EGFR. two-parter for questions. plus You MEK a data guys. We Hi, for had minus upcoming the or David,

about combination alone. just Just collaboration And how goal interpret and SHPX understand a is to beyond with about second a Novartis think increase to around spreading done SHPX, study. it Maybe to that rate how the PFS significantly think that announced you or in data, to there. that us to democrats diversifying if have you the also good how wanted expanded is Thank context, that data, you right-size you. just what and is and help the response

David Reese

Thanks, Mike.

the start first. second me Let part with

forward diversifying experience. as combination both as datasets. our You're Revolution [Indiscernible] well new Novartis That's simply noted exactly on right. this with collaboration both with to as We're we forward moving Medicines look I

or vary to are beyond it's to XX% rate, course, and terms of sort efficacy. is Thanks going In see to in of on response I've of and as those you what response But And what then progression-free terms critical in generally, want the in rates cohorts and that doses, and again. increments the first of sort certainly is of upfront XX%, terms XX%, rough use. said safety want indication benchmarks that typically we see. improvement moving relative appropriate of before, combinations, first-line, survival, the cohorts, determining and thing EGFR we'll would MEK these for into by expansion line therapy of

Michael Yee

you. Thank

Operator

with Cantor from next is Your question Young Fitzgerald. Alethia

Alethia Young

for And to of taking my Arvind. birthday guys. cheers IR to Thanks one question. happy And games. in best Hey, the you,

Arvind Sood

Thank you, Alethia.

Alethia Young

of Do can the we're how you're I volume I to a you've nice pressure sequential know little if might or flavor that and talked but you're volume continued point? about seeing real start to about growth, the pricing you the little from stabilize of deceleration, kind I wanted give that generating. bit right us bit see on to size get think of some think stabilization know pressure. but when hitting and a growth Repatha, very on of like you flavor and kind discounting

Murdo Gordon:

Repatha. reached happy we with to patients treat now a the a million Yes. performance and patients, Thanks. now Alethia. We're us of large Repatha number with really of quite

really as business patient coverage segment D or dynamic refer dragging donut percentage D D the quite expand and Medicare the in as milestone. dynamic, So U.S. we gap hole. business down or is as Part our price share or enter the of to The we Part that a of market. is into overall Part sometimes the a patients And

will price drag see net-negative We quarter-over-quarter. some

-- to we've be not as made historically. precipitous changes not it's going the as Now, price that

see volume drop lines. is sales the to So, we our will that outpacing and that net

Repatha price stable overall, year We're is relatively nice also evolution. the So seeing good growth where on ex-U.S. on year.

evolution it's sign as bolster did drag pool Medicare time we But because helping is a of mix means the will some of But again, we're well. than part expanding good more over price patients much that continue. it that slight rapidly So historically.

Alethia Young

you. Thank Great.

Operator

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

Kennen MacKay

X [Indiscernible] [Indiscernible]. and Thanks you perspective see it's excited top the MEK about line more the question. Novartis the might seat? so Maybe earliest now SHPX with in take the the and on your the maybe, the congrats just And combinations just oral for quick currently you to LUMAKRAS, inhibitors, MX then antibody launch does it's with for most would whether biosimilar on pipeline, EYLEA, with get the inhibitor on love or question previously a you're when the much able to XXX? ABP that collaboration. taking Thanks do be biosimilar to

David Reese

question I'll the on start combinations. with Yeah. Maybe

course, we're in all if I, this of that's And ones one really and empirical importantly, of are think covering the with point, combinations like of additive I background for think interest work Ken regimen, And terms part generating waterfront two, that a or combining so, I outlined. and matter data. selected course, we've another the the Of at we or to believe either of are relevant And molecules combinations in so testing of it's an then will here. we and a have that most is what really ones as indications of share reason we're It right would biological One, the reason -- possibility. now. or synergistic these actually best the been effects. both.

Murdo Gordon:

quickly the on And, timing but we being that Ken, and enrollment for early of anticipate we we and haven't product. are announced the EYLEA, that of launches in sequence in our program moving

Kennen MacKay

Fair enough. Thank Murdo. Thanks, much. very you

Operator

Barclays. Your next question is from with Carter Gould

Carter Gould

my pass happy I OXXX know moving afternoon. wanted Good too. to year. into III I'll birthday I wishes your ask next on Phase program. about it's Arvind to

market, underlying to around color the any the in on Thank looking as JAKS, changed over it forward lingering or that you. assumptions be would wanted or uncertainty with dosing your, to if see III. in the Just helpful? way any Phase further evolved you're move your population And

David Reese

there residual Yeah. of think medical therapies. Atopic therapies. this is populations. a about actually need. through despite existing net very often enthusiastic Thanks, is Carter. disease We Patients molecule. widespread very We're amount with dermatitis large in global cycle prevalence a

there we're impact mechanism the have field. targeting We of this pathway. action, a in think real a novel big to the OXXX is quite opportunity Given

X and be which course, have thoughts of may in on program, the on As discussions major and our meetings I like our regulators, get what plans you'll likelihood dermatology at Phase presenting we forward, at all dosing data end there as Xb European of a mentioned, sense September look things a of we'll of and of we'll going be outline phase studies. with think I the will the the one suite

Let me comment here. to further ask Murdo little a

Murdo Gordon:

the the that of second-line of the the pay biologic reduction concerns Carter, by market asset one in that asset. OXXX can the think once were market. And will attention to we of and the JAKs obviously And to We portion market initially we attractiveness play. I We was in drivers safety close the still as will raised think considered. when think we the applied role some JAKs from evaluating penetration the there. AD establish the here. assumptions data But on was the Xeljanz Yeah, we expand [Indiscernible] a to opportunity OXXX that perhaps has probably large a addressed than is smaller JAK be

Operator

Your next with JPMorgan. question is Kasimov from Cory

Cory Kasimov

go is back happy importantly, Arvind. afternoon, of LUMAKRAS the Thanks birthday my what guys. good specifically to and questioning work trying figure most point, to just an doing it ask you to wanted Hey, for question. line expect still about before you. at have around taking there. dosing forward? the And this really currently the update move about out with to Thank you I And when combination to PD-Xs you're

David Reese

Cory. Thanks, Yeah.

we're at therapy sequential and looking before, discussed we've direct here. both As combinations

I half to define is so those the sometime expect or can enough next relevant of see through the data both see of as checkpoint inhibitor. you from a you forward accumulate first can what to think year -- So, data with path we

these development So come on but to actively work to continue more there, we programs.

Cory Kasimov

David. Thank you, Okay.

Operator

Raymond Your next Sandler. Chris question is Piper with from

Allison Bratzel

for Bratzel is for Chris on Alli This our afternoon. question. Thanks this taking Hi.

lot in inflammation oncology the activity and had a you've PD, on space. Just of

more development for your innovation. renal, how maybe are on on how in internal you're the renal. opportunities of on color interest your prioritization prioritizing or about commercial franchises you bolster some or any areas versus And Thanks. of franchise Just then specifically legacy to via strategy investing external thinking more side the longer-term other like

Bob Bradway

have times repeat an our many development ongoing efforts commercial I'll where is we and/or strong just on So focused presence. said business areas before, Alli, that I've are what which the research presence

So, in you're area. we've active oncology been and immunology in right, the

general opportunities see in in spaces that to to value the well medicine. for bone as continue both those as well. we'll to or we We we're or think the health, to going things look we nephrology that migraine as extent there add in And area, look

think are on and earn might So effectively, in across medicines but advance look, we needs we extent we our focus shareholders marketplace haven't there, well. from underway can assets active to are again, how efforts or we example, return to the with we the a and to for of there close the opportunities actively. seen in license therapies We'll that as the that think have don't of the things marketplace with you bone or just nephrology -- we and we research leadership that the in Just our very fit moment. our addressed addressing at pay I attention well active leadership, We novel internally for Are XX-years I outside just have as global nephrology acquire. are quickly. sorry? Amgen your nephrology And don't the question. that bone, because much

Operator

is next James. Your Dane Leone with Raymond question from

Dane Leone:

But the of lung do last had data update that you planning seeing progressed Thank you. you year. what maybe you studies since be in about escalation you a and thinking may the cancer lines think study positioning small-cell we've different this have has where earlier about this dose to to now, for what Arvind. my is call, to X questions so data congratulations think Thank after Hope you you're have from Tarlatamab. here you Hi. need Obviously, guys Phase encouraging Question fun on questions me birthday the the seems My for and keep see initial a study? you the first I'll now? as drug pivotal want seen the brief. tonight taking from patients it you as XX this

David Reese

cohorts is saw impressed a are we've what take the And lung thanks, in that responses last cell consistent are we've think ongoing response plus, consistent rare. actually ago. in rates which, later -- to you of data aggressive presented I or with response we Yes, with you part vanishing these rates X month the Most question. the that a durable of are Dane, with the cancer. patients from seen small been line And addition, know, disease third duration as of response. here very your

addition. I think that really What is us encouragement in here. gives So

with of potential the focus be FDA lines discussed therapy. the we the weeks, initial those I but will think we coming foray registrational the likely As I later on the to path in think patient population, is

Tarlatamab. program actively as game that now. well. we're that of pointing in in is the end right And forward and the earlier seeing for lines clinic therapy We now our activity the development given are we're That investigating moving with sort clearly are of

Dane Leone:

Thank you.

Operator

Schmidt Your next with question is from Guggenheim. Michael

Michael Schmidt

have X taking Thanks on And Hi, well. guys. as Arvind, congrats question. LUMAKRAS. my for I more [Indiscernible]

of profile likely inhibitor a which others are to come be could or logical broad guess, I should to mind? are other think I out be access possible. combinations chemo combinations Should LUMAKRAS So, are hypothetically, first-line avenues to guess turn efficacy the cancer What there we Thanks positively to about KRAS safety be so indication? insufficient, potential that lung enable much. non-smoker

David Reese

Thanks, Michael.

exactly I think you're right.

number And selected combinations, one. With chemotherapy into then populations. biomarker the going

first-line be our As in terms launching which planned on shortly. of we'll discussed upcoming [Indiscernible] we've

to we most benefit. should piece inhibitor not first-line would be routes that to other together expect patients so, feasible, would find likely And I are to checkpoint combinations who

Michael Schmidt

so Great, thanks much.

Bob Bradway

take against pushing hour, X questions. the the why final of Erica, up we top don't as we're our

Operator

Okay.

Brian with Baird. from is Skorney question next Your

Brian Skorney

of my today. question a Hey, happy good on deficiency afternoon, Arvind. everyone. more the disclosed birthday, for taking and Thanks Thinking notice little

IRS year to under around XXXX XXXX for like received through I Rico. also profit modified this just you last all-related by allegation investigation are seems related is through also Puerto an and and [Indiscernible] [Indiscernible] XXXX XXXX think issue and in the

for you just to years and now be? XXXX So, for petition. that of fail? methodology liabilities goes court the the through would well. what you if establish number against in walk can a could they that tax XXXX, in the to it decision through the IRS sort of based to XXXX, wondering was And does run next heard bound Can be for you, the calculation does court -- if of established as for petition other tax precedence steps I go have on same the terms calculation for And

Peter Griffith

IRS Yes. to XXXX you significant this [Indiscernible]. to Brian, is Look, also U.S. case, The several years proposing issues. resolve. petition question. a the thank with it for tax the In filed relate could take we adjustments and similar 'XX, to

know. strongly audit. XXXX We're the as disagree, the We adequate that. As for you The auditing We Office have years through with that that. Administrative the Appeals resolution currently sure believe adjustments. disagree on they're IRS the we periods proposed IRS, a the notice, pursuing yes, under so they'll other position same you reserves for with 'XX., take we're

Brian Skorney

you. thank Great,

Bob Bradway

to question. let's final go Hey, the

Operator

question final from Anderson Your Wolfe Tim with Research. is

Andrew Galler

Hey, Andrew to wanted Galler Tim. just on for one I ask is [Indiscernible]. question this on

given your high So, impact atopic last of can AstraZeneca about you conditions? look officially your positioning? on any availed competitive partner dermatitis discontinued Eastern do atopic given to week, decision The talk asthma, coincidence the be

David Reese

given extremely count. about bullish tezepelumab, remain and a I across with activity of mean, its we answer I the think is short asthma, no, regardless range eosinophil patients of here

need. review As potential Clearly this an medical with we medicine were of unmet by priority the granted a the FDA. of mentioned, we residual acknowledgment large fit

positive [Indiscernible]. That doesn't give that's So us [Indiscernible]. really

Bob Bradway

about for our callers a Okay, me just lot going the call the on here. year, let We're Erica. the Well, thank joining half second today. excited of

you to in on interest quarter. And forward with opportunity so, look you. we Amgen. update and you next October in having the to Appreciate Thank your gather the

Arvind Sood

Thanks, everybody.

Operator

call. Financial Second conference This XXXX Results Quarter concludes Amgen's

now disconnect. may You

Amgen (AMGN) 4 Aug 212021 Q2 Earnings call transcript