AMGN - Earnings call transcript Q4 2017

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Operator

My name is Skinner and I will be your conference facilitator today for Amgen’s Fourth Quarter 2017 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

Sood, you may now begin.

Arvind Sood

Okay. Skinner. you, Thank everybody. Good afternoon like to to our our would you for welcome our business call discuss and conference performance XXXX. I to for outlook XXXX

reform on Although our for our driven our results and profound focus our growth, and exemplify industry tax has company. opportunities created changes volume

guidance Bob results QX our XXXX. to Meline CFO, for So CEO, who this and and some provide will our dialogue, will begin our full David XXXX year perspective, provide and review Chairman Bradway followed by

Our by Head Tony Harper, will of of pipeline Global Commercial Hooper, performance Sean a review Operations, geographic and update. in our who R&D, our product will provide XXXX, followed Head

was financial which maybe slides presentation As to business link today information, our sent in measures to plan provide understanding presentation in slides performance. a earlier. using on in past, the We will today’s non-GAAP use ongoing our corresponding and useful these we to

financial reconciliations Investor release, with X-K measures of today’s together press also should a considered measures However, website. our the section accompanying in the on these these available and of non-GAAP schedules be and Relations Form results GAAP are

XXXX today the forward-looking a our differ to that of during statements identify presentation that subsequent and Just the our reminder and course made statements actual results filings of some our factors XX-K cause are could materially.

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

Bob Bradway

call. our joining for you Thank Okay.

remarks this more usual you We our to afternoon. than ground prepared with have cover in

to development business addressing behind business. year, for see solid another period leading operating tax kick are year an be return we would for about capital not XX.X%. more we results to reform, payout XXXX ago. on X% we XX% improving our earnings a to In this of we favorable future these I us, operating year delivered by our of results were the but a the continued margins shareholders XXXX, even long-term To protection our In continuing will We impact heavily that growing for of strong our industry deliver our very competition off, is our the excited invest which with our in terms, We patent performance performance for prospects than offer and of only to also outlook per improved increased share business. and our grew to XX%. of products, of in while and for as several capital we as have a largest lost which many

growth provide beneficial deliver healthcare fits in value industry, balance stakeholders Repatha, support continue think XXXX. drive suffering set coming to demonstrate long close To are essential future the on places nephrology be and data all our through years to successful held medicines that strong expect from The brands be ago serious progress have led outlook. will to effects and patent attractive sheet remain our squarely we capital our use Prolia, people growth and for for returning XXXX franchises to up and them have the are expect steady innovative, these also them our that finally, invest and to we with our intend our that We while M&A large And behind KYPROLIS, flows differentiated in the both and emerging run are we of we including Aimovig strong system. reform. which our where about course and in the cash oncology and a by have position we competitive. our to against focus strong several illness XXXX we encouraging. to which opportunities We have stable patients tax Our the Those by biosimilars commitments now for resources in to long-term in industry, to shareholders. to see well the in it come in deliver medicines off improved of long-term long-term track it confident entered we us had the and

medicines meet We now be tightly the think of pipeline, our number growth which and these prices of to we have market markets. more some some patient more needs specialized of the on are pressure linked and numbers In for the last and in With trial. of is globally, a a particularly revenue year, populations will large outcomes growth on will be regard serve of On of growth historically. this successful medicines case announced the example the large call we the needs clear Repatha conclusion attractive this drivers. was that of Repatha volume of patients this. which

will talk following problem is risk the single embrace systems an greatest about to to Now prescribers Cardiovascular in unless today bring disease. patients, role is significantly the world of the by ages we heart of cardiovascular population stroke. to And able Repatha risk the of the innovations. are new millions FDA, only payers around type attack facing innovation of disease and the the unique reducing we and needed expedited today. healthcare the Repatha important down review by globally, exactly patients grow this of as problem

risk and high it to Our job now and recognize patients the for the payers is adopting understand prescribers, importance patients. product see this of

many to us years for they driver come. be do, expect the Repatha important for As we to growth

leading to patients course We a effective. for first represented it to biologic proven in will Repatha, was Like not access osteoporosis when that those gain especially to this therapy therapies Today therapy. is change osteoporosis. paradigm other Prolia ensure launched for work have of continue whom the worldwide it

grow there who to digit potential And our pipeline, XX% characteristics, in women for demand worldwide osteoporosis therapy which diseases. two fact see but symptomatic address have of which continue I Prolia similar products it, receiving we to osteoporosis. in the In will for Prolia. growth by might are more highlight significant the percentages. continues it double In from U.S. only taking With million benefit patients X.X attractive

migraine. a and to for adequately disease One class debilitating better work don’t Aimovig Current a of and these to anxious are is and first prescribers therapies option. prevent patients this product in have

will CGRP the millions waiting which receptor We patients blocks are that hopeful been be that have for. Aimovig the answer uniquely of

is The I there. Phase will shown There other highlight sufferers millions first treating that Tezepelumab, of therapy. of molecule has a results are X asthma asthma encouraging worldwide very in product better class need in in

hopeful just the are the that enrolling that trial to might We we be actively establish Tezepelumab are Phase and answer. X

In medicines more to from KYPROLIS is success survival fresh standard. growth and for specialty myeloma we gold in second label, entered of established and example this share in XXXX. more to in great of cancer myeloma historically our of enjoyed multiple and continue. BLINCYTO. in expect We the this. overall have product data represents we overall and a addition We generally, later XGEVA lines KYPROLIS with our strong with has to that And innovative labels markets see beginning survival would expect good therapy. our the with XXXX multiple

the our overall in importantly addition expect for broader We long-term but leukemia to strengthen BiTE acute survival relapse of its the appeal payers overall it confidence a lymphoblastic patients. to data With its own patients for refractory physicians, and changer game outlook for right, provides platform. was survival BLINCYTO

in over year of will be for X both progressing many the XX these product Amgen. future for and molecules. XXXX the years new launches And inform another liquid next have of BiTE We solid programs tumors. data will

plans long-standing launch U.S. in a product extending our number to addition launch of with nephrology of leadership for disease Aimovig, the specialty for we rather, in our companies – the are kidney countries Parsabiv, a In including

year. adalimumab AMGEVITA, we to Finally, biosimilars launch. clarity that highlight that our will This first launching to to forward around in the have I the of biosimilar. later now be we look want And our internationally

coming several We X number for represent waiting think it tax one provides compelling these recommend and opportunities us think launch. the with approval We approval world. have a already our strong company. of reform benefits important portfolio and a growth for programs behind We around Phase other –

it a their and who global by to us more First, level were international advantaged lower previously field access with cash. playing rates strategically competitors puts our on

heavily do. reform provides the now technologies innovation of and us to playing waste levels tax cusp particularly which timing in here deploying improved enable is of Second, tax to so-called right relevant impact. much our much bio-manufacturing environmental biologics thanks a and on technologies, clearly make exactly will next-generation The developed advanced are for reform. that reduced with the footprint and and is in tax U.S. in level addition us we these reform U.S. for to we more and productivity, in incentives as We us invest a smaller of what technologies field, to the

in the new as biotechnology, Amgen it the to $XXX in make capital in tax manufacturing on will other sales. U.S. in with build We expect highly We XX% available and close benefiting the years. Ventures, them. With the areas order expenditures $X.X our of tax investments product vehicle will over in of to new also It’s in capacity we invest clarity next companies. to we our on on tax will and early-stage U.S. here digital well. the see reform, U.S. export jobs skilled to improved us reform investing make add for worth that noting million X capitalize reform for billion healthcare international innovative information cover now

programs, Amgen million grow to which plans the Amgen biotech expect of commitment within years. substantial Amgen Foundation’s with reach also investments $XXX scholars commitment will for the proven We our communities our experienced to in we already and X

XXX,XXX Foundation’s engaged our U.S. deploy we some years through in communities and scientists programs giving, helping and live. our X the work students where consider next in of philanthropic and over in these a we school the talented this biologists commitment have beyond. expect million to Through the to We high and $XXX pipeline college person build

be XX,XXX. with all in improvement dollars assessed personal that we base U.S. of average enhancing these generally are Amgen with stock, number you globally tax typical literally create that of quite held fact non-executive staff staff the rates, will wages for of estimate this XX% U.S. for will broad. take-home When reform member. some investments for reform can also pair benefits be who staff, non-executive of We see staff, Amgen have combined We the have members of the our the will in our about making our you thousands for tax staff that tax especially positive all lower pay

we XXXX, us and acquisitions billion long-term Since in capital capital have provides more research for development, invested also reform tax deployment. innovation-based expenditures. and $XX Finally, oriented than more flexibility with

to of to the our of tax share our long-term is excess for reform Based repurchase by return enhanced to on while confidence the and able now, investments also our buybacks. continue and capital business form authorization We being increased such billion. benefits by the have share shareholders the dividends in expect making we long-term outlook growing $XX

shortly. describe on We expect shares this year an as will retire basis to accelerated David

the our serve our you, patients for highlighted of we benefits of I but for seeking are the investments that to come others, in staff, tax and come expense not making do the at As the communities. we to our reform shareholders for addition are

So, the to operating reiterate, business well. we are

in of Hurricane You response that it have in our Maria our too. and to challenge seen you successful extraordinary financials the saw

Our in-market products are strong.

pipeline healthcare environment on and balance We assets advancing a to have to our Strategically, well-positioned are for pressures attractive adapt the to and capitalize sheet. strong opportunities we the the growing consolidation we shareholders. have in in

are our beyond. Let XXXX serving of thanks you driving around devotion and in patients and for our they assure to on me I conclude staff their can mission. a word with the to growth tireless world focused

Let’s to turn David.

David Meline

Thanks Okay. Bob.

moment would I several to Before the review guidance, I and like reflect a on over to last our results years. take performance our

As another of performance whole. evolving year, pleased I a competitive challenges dynamics transition delivered in In as as to that XXXX. positive which we we not presented portfolio significant including industry entered Maria, of face Hurricane so the these am as well related challenges the as XXXX report our expected other and to the the mentioned, Bob again of expected

with regard have have on commitments goals, already we X-year our delivering delivered sight we clear to established or the of to XXXX. line Additionally, in

XX%, and goal point speed objective our resulting non-GAAP improvement of in operating We with a of between increase efficiency XXXX, agility our was in operating and this the to outcome ahead achieved first substantial achieve representing margin a midpoint. XX at X commitment. the years starting The XX% the

savings commitment exceed Second, in XXXX that transformation will we goal in $X.X delivered billion and XXXX. the

to infrastructure, are our our fixed goal through XXXX other our track capability footprint meet on efforts Third our facility by as reducing as bio-manufacturing of capital next-generation we to XX%. well optimize

achieved to and before XXXX performance pleased period beyond. key net today’s These the commitments are during on delivery further the from tax least XX% I based Amgen’s both expected XXXX objectives of Finally, XXXX which am of on benefiting non-GAAP on enhances guidance to shareholders average income being double XXXX. providing and in non-GAAP reform to of confirm digit EPS our returns at other growth

financial slide year-over-year. to the billion Now $X.X declined let’s results turn Revenue fourth X% the X of at on deck. quarter Page

This $X.X quarter growth product demand we billion saw declines. worldwide products product largely our from offset unit sales as mature at

markets out-licensing experienced of year-over-year are $XXX of as of particularly transition growth decreased by number revenues biosimilar XXXX milestone in competition in We U.S. international in our markets, at fourth innovative million XXX. AMG outside encouraged years. Other products a of payment of value related for year-over-year the a which million, result quarter received $XX have volume reflecting our many to the the the these portfolio and the of XX%

quarter. declined from billion prior Our operating at was the XX.X% margin Non-GAAP year. QX operating for non-GAAP XX% income $X.X

reflected the underlying operating our quarter pattern. fourth indicated previously As typical expenses

additional Hurricane as of quarter incremental tax accelerated planning related inventory costs, as well expenses the recovery expenses number a million experienced also Maria $XX in costs. purposes, of including for We

XX.X% Finally, royalty million all expense volume Other partially net These was favorability increases expense the XXXX. in portion interest expense we and for were in venture in items Aimovig rebalancing XXXX. in with higher on patient continued and this these portfolio of This products favorable in of on by unmet transformation portfolio from $XX of the and a support both year, growth populations, launch gains as offset to QX. year-over-year fourth basis. income, launch. investment residual categories due expiry our were primarily in quarter expand our preparations A driven of investments effective of compares a This these were gains favorable coupled million rate XX, expenses advance activities earnings X.X QX in non-GAAP the of increased anticipation operating initiatives medical impacts on of from favorable was large accounting upcoming quarter, a XXXX. this point for is of the the across year. activities income versus The $XXX of October XXXX taken in our in the changes and in year-over-year including mix addressing favorable changes tax we needs in improvement Enbrel standards our geographic reflecting payment tax

on The an non-GAAP net be and of was we our GAAP summary impacting quarter full including a U.S. flat income over to tax P&L, While repatriation revaluation will X% share, our non-GAAP of not year the deferred tax results government charge fourth for tax earnings X-year and presentation. corporate U.S. net P&L the quarter. incurred X per reform, $X.X Page to billion period. liabilities. repatriation the related find paid fourth year-over-year Non-GAAP decreased Please the XXXX a of on our tax

X% to non-GAAP year $XX.XX per full our share. $XX.XX XXXX per while revenues X% earnings billion, Our declined share grew to

sales impact Changes sales For growth product the for had the a saw worldwide year-over-year and full year we product basis. billion. exchange year, $XX.X X% full of in a negative flat total foreign on revenue to

including Hurricane billion grew at operating income For Maria. expenses nonrecurring from X% the $XXX the $XX.X associated from of with year, recovery non-GAAP million full prior year,

our X% expenses offset growth lower by basis, cost margin stage driven spending by the as support the and driven our large XX% is expenses our points transformation million X% annual a percent product Included billion and costs programs. to expense incremental therapeutic business product Research maintain benefits a XXXX, XX.X% $X.X to development income operating year-over-year lower cost Maria other certain an Unfavorable decreased levels. Enbrel non-GAAP this expenses end in primarily business build royalty new and related launch by year billion. initiatives address of million in of which inventory global versus residual expenses a the $XXX products, our increased required required on the investments decreased out ongoing biosimilars advance and to overall have from increasing increase Other operating we Through X% to mix XXXX within to later offset of total favorable of year-over-year needs as approximately sales by were basis areas, the new presence. $XXX expiry by X.X and non-GAAP royalties the $XX.X by the clinical efforts. decreased due on well to in income of partially populations. compensation total, lower external development mix SG&A was we year. tax year, gains rate sales manufacturing and benefits efficiencies. points to as share-based as non-GAAP full On lower to decreased to year-over-year tax for payments. XXXX. due across driven unmet partially down and changes volume Enbrel X.X payment. X.X realized recovery higher the and of offset partially year-over-year interest expenses decline the Our primarily and XX.X% for our course Hurricane versus cash residual non-GAAP higher expiration of from earnings venture by points The balances the was In geographic products, drive our by portfolio operating year-over-year patient the milestones by primarily royalty realized of expenses The improved

Turning next balance X. the on sheet flow to Page cash and

primarily end $X.X debt we a of of an authorization. weighted our at billion This XXXX, remaining to XX.X average share and repurchase and year in repurchase In favorable flow to on U.S. For and of at generation capital. had billion end working strong operating interest maturity Total At This $XXX average durable billion XXXX, full deployed year cash balance changes driven $X.X to billion XXXX, $XX.X totaled the $XX.X and was per million versus billion demonstrate investments billion an included X.X% in continued carries year. Cash increase and U.S. income of and the outstanding increased cash free by outside in last shares average $X.X Amgen $X.X higher the existing $XX.X share. with rate billion billion. we the $XX.X flow years. XX

Additionally billion. also confidence strategy, for increase of allocation on XXXX. enterprise payments for per $X.X XXXX, in our to to dividend share quarter share and commitment quarter, the $X.XX XX% the to XX% by Based we capital for we outlook our per increased with dividend the first our to a totaling our per announced continued future the $X.XX

this new XXXX pipeline, supporting business In the as XXXX anticipation for the in X, the will to on for important be for Amgen over invest outlook year enable position fully business our to from global another growth. our a investing we out several continue continuing past of opportunity long-term to the Turning transform building strength. leading product of Page we and years to industry us transformation for performance invest and success. to deliver us business while the This allows financial growth

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

year. Our a reform There would I that is are of key we million $XXX the guidance non-GAAP capital of impact tax tax XX% XX% to rate outlook several like moment embedded our share. in this to assumptions to reflecting expenditures and expect approximately take

First, products products. legacy evolving newer continued positive guidance our dynamics our our momentum as as both to from competitive reflects related revenue well

with inclusion have of growth data important the outcomes We opportunities label. in Repatha’s

of Our cash added and use and sheet balance plan to enabled drive to growth the our Aimovig to flow strong the by and tax launch flexibility products including new company. continued AMGEVITA reform

competitors. March, patent potential Neulasta and the regard we involved composition with the and and against potential possible We Sensipar, formulation competition the expires over are of pediatric also expected dynamics embrace new to including litigation Aranesp. Enbrel to With FDA separately in generic matter in competition Sensipar, with patent continuing over generic although the challenges exclusivity competitive for the

Also year. the represents timing sales to in uncertainty competition until becomes the our we note that as historically of outcome will quarter the quarter the the litigations these first product for position Although strength lowest remain believe clear. of the of

products the The expect For XX% in have to this of provide be of year. an delivered we between a in again half will the today’s QX, XXXX XXXX, our year to XX% XXXX margin And up growth From and see will as operating related range other in respect unfavorable perspective rate non-GAAP continue. on we in expect remarks. operating incremental large we a to royalty in based this pattern in milestones full impacted invest continue operate on With further Tony offset of quarterly expect in to drive to commitment run second for our volume this we year-over-year patient details XX%. since true guidance the to by margin we an this populations. to growth. by revenue, XXXX

investments maximize XXXX a balance incremental and our and of over Going globally forward, next reform is XX% and drive on to billion. follows. we XX%. the capital the tax non-GAAP competitive The regard earnings. ex-U.S. XXXX tax immediate ex-U.S. between flexibility legislation value. significant will rate incorporates rate shareholder growth passed rate our provides in guidance, to tax With continue forecast recently of including end regard the XX.X% financial $XX form cash With a to tax U.S. evaluate tax acquisitions several to principles as rate deployment, This access to year and XX% on are earnings years

we our our expand and to invest continue across populations. growth volume First, we business globally drive will seek patient large to as long-term pipeline in

we We to will manufacturing support greater in the growth volume foresee. also invest capacity

the the time For us reform to investment in tax consider in decades, enables U.S. competitively first several

years expect approximately XX% years. billion will up we capital in of expenditures. result $X.X next in the be X a U.S., recent that in the about invest XX% approximately to in As from XXXX, investment over Starting

substance strategy Bob manufacturing mentioned bio-manufacturing our be plant component key capital using capability. a As which U.S. drug a investment built includes of new will our next-generation

expansion complete a to this time of of cost. expect approximately the conventional the one-third for half plant We in about

as areas we venture our invest continued will global investing as addition business million we pursue to to build-out. fund. our our of external growth Furthermore, chosen additional an to in our In well $XXX accelerating accelerate opportunities internally, therapeutic the in

venture have in important to appropriately invested an and are advances invested informed, science, in tool funds. ensuring is cutting XXXX, billion engaged edge we and Since technology over fund in we our venture Our $X.X innovation.

have investments of scientific returns above these cost importance, our In generated capital. addition to their well

cost optimal fully capital committed in remain capital order cash weighted deploying to capital of accumulated excess any structure accumulative an average will or and forward. deploying going we minimize – by to Second, flows

this a $X.X an to Board billion up of stock. previously at authorization addition share end step the which XXXX. to accomplishing authorization common we objective, to to $XX billion of This repurchase have approved the As at is first received our remained purchase

of may will scale next capital up we the expense full and week. up a excess to Further, authority tender XXXX. to of result Given tender the The to as lower capital due less plan we deploy, used as we of be This net in in half in will the the beyond to would income have cash early equity is to our consistent successfully would in offer, repurchase we for auction optimization commence interest first Dutch XXXX with XXXX. offer approach with our proceed $XX million have balances. and higher structure interest as

to For million net XXXX expense. of expense income million this and expected $XXX results in $XXX other

it important the in to the additional over capital efficient excess years, flexibility to future. translate and redeploy could we next cash we would upcoming in maturities pay is find most market. debt This manner that the debt rather capacity in that financial than refinancing our several deploy prudent the could we As in directly choose into some

well share as to shareholders previously meaningful will the dividend as returns through provide Third, we continue repurchases mentioned continued growth. both to

outlook the sense year, addition It our another and that XXXX is financial ranges a remain XXXX in confident the impact reflection which revenue future in today we financial the beyond. of and to range than Amgen primarily call non-GAAP Finally, activities. of strong guidance the to start scenarios potential I today’s other of turn of of in the ongoing are update. success important EPS does In provided not Tony. typically we now wider include of our we at recognize year M&A over is to the the results and uncertainties in concludes earlier. outlined guidance have the delivered will summary, This for

Tony Hooper

by XXXX our overall would our performance few you, performance. followed to begin a comments Thank with in on of a David. review I like product

play newer as growth volume year declines full the four recently as Prolia in in mature and XXXX saw of ESAs decline launched quarter robust brands On volume basis offset were products XXXX the this by the line our Enbrel, our We sales again in in offset our brands. led and growth NEUPOGEN. with out

focused competition. across We was growth has in lifecycle our European international several of already several led transitioned execution performance drove the team We volume and of brands as some Prolia. sales with has made increasing strong management leading And majority growth. quarter am of in volume by number XXXX fronts in progress led brands portfolio. executed long-term to exchange, the volume across growth the impact by strategies. said driven from excellent the four a to driven defended for growth XX%. by Enbrel The foreign portfolio XX% we strategic important I with newer patient strong pleased building our against foundation our for growth and overall of Europe Our David excluding material of volume brands

clinical and recently new for OUTCOMES sets advance as launched to our two overall continue data, course Repatha being most three as survival for one KYPROLIS significant new We of data. impressive products well data with of BLINCYTO. The

for begin next as wave differentiated to we within portfolio AMGEVITA, are Humira on and innovative we our am in We our the will our well-positioned and biosimilars exciting be later began in opportunities as confident Aimovig, this of commercialize medicines. milestone in a our that the for laying I of an to capitalize also migraine XXXX. launches we year. This biosimilar foundation the prepare Europe product U.S.

Once presold initiation On continuing XX% now year have of growth Turning market initiated we X track our the patients and ended record underscores now sustained in Prolia we U.S. new unmet patient performance, of patients of quarter product globally. XXXX. years are repeat need. full Prolia basis, Bob as new growth injections. the number patient said a medical to the good in After starts Prolia impressive on X.X of a million grew year-over-year. this a achieved record XXXX with another In XX% with

progress, suffer XX there are who the suffer above XXX two an great in a While this osteoporosis. osteoporotic patients every fracture. U.S. women one from In will is worldwide million

work within to market. will and osteoporosis market strong continue investment, we expect remain driver. very continued sustained growth diagnosis share Prolia’s the as So we treatment we grow With to both and the the unique improve Prolia a profile of and through this

survival data Turning paradigm markets the survival KYPROLIS demonstrate from have patients. XXXX. approved standard reduction ASPIRE KYPROLIS robust. on regimens XX% from overall KYPROLIS doubt, treatment our adding are, overall as data label. equally later the dexamethasone the impressive myeloma now sets in in endeavor reset should We These this impressive multiple in NCCN study look a label relapse the just without from is differentiators doublet to regimen being U.S. forward the sales standard with the FDA to Guidelines. year-over-year Uptake plus year. and only data added to care new death preferred overall performance two survival internationally. setting. doubled for oncology to versus of fourth our grew a in strong Europe has triplet these data both the quarter the the risk XX% of in that quarter In of compelling Fourth brands, The in care of each doublet remains and

a continues improve. price. showing Patients to selling treated combination as inventory and will relapsed driven are message KYPROLIS clear. net new is with effective by is volume KYPROLIS. And in up patients early focused longer X% when live physicians indications grew of this to the changes XGEVA or well that relapse regimen Our pretty share growth, year-over-year includes or that presenting

portion is patients This patients a sales approval example myelosuppressive of we and injection volume begin of we designated to the of are bone XGEVA XXX,XXX date pleased over large slightly Neulasta and first treated year regimens an oncology producer are within for the therapy, be of growth. ahead another has toxic cannot growth to myeloma. A traction the patients with decline to acid to in for many of sold. neutropenia at the more lifecycle five therapies. received as and febrile patients This is XGEVA this of flat continues were chemotherapy them compelling days be convenience proposition XGEVA. the to related rates adherence units above and was these XGEVA skeletal the exited continue label of renal U.S. approval low the patient and effectively therapy see expanding value with Onpro for novel of lower patients system myeloma issue Neulasta management XX% the has new practices. delivers driven to a to We and in include FDA’s help and CMS recognized due as XXXX our better It insufficiency. as myeloma multiple events approval nearly risk zoledronic in patients. can strategy gain multiple complications. these and prevention month and in with due Its single-digit hospitalization year-over-year U.S. investment less of for in use clear. healthcare to multiple the

protected patent Our the in of against point competition. Onpro marketplace potential future be will differentiation an important

be to about we last be On a will there the know during amount now. arrival years for the their competitors where serious of market topic the U.S., questions potential competition continue announcing in in the new some of year the

with we the with in to If arrive half able XXXX. do market come ready they succeed With the exited be for will and such as they XXXX fourth share of in second trends quarter consistent finally as prior XX% courts of the short-acting regulators could on unit short-acting will with biosimilars to maybe market. the be the Neupogen, We were impact we in them.

since continue entry pricing We maintain discipline the competitors. to of

volume year-over-year, in declined was which fourth prescription XX% the to Enbrel trends Now in line turning demand underlying quarter. with

well across in each line rheumatology as share with segment as Second, in growth quarters. was prior Enbrel’s volume and changes in dermatology

position you decline is a forming resulting price. in selling I in patient Enbrel’s access strong small maintaining As net and told quarter last

unit We the both and trends quarter fourth price to expect into for demand net selling XXXX. continue

will as quarter patient You re-verifications XXXX recall and new last the year also for the lowest deductibles calendar first insurance year. was the quarter of reset

ongoing very representing to expect quarter year We to selling with as innovative XXXX prior strategy these ease new year the This X% to and favorable basis designed also approximately pursuit similar very be our been our about supply of year-over-year differentiate EPOGEN benefits of auto Mini is a positive our on this business with business. of for with year by reusable specifically lowest enhance adjustments a until this the and launched our was used is Enbrel to experience shows driver declined foreign to with are ways the has rates. unit relatively AutoTouch multiuse with out product. XX% to with environmental exchange now low-paying Aranesp be XXXX, proud arthritis result therefore of feedback Patient and being along XXXX ESA Critical experience agreement remained unfavorable we by the full and net positive a sales dynamics patient to new the device, Slide on innovations lower demand, of our injector. Enbrel’s sales. price expect Switching Enbrel The XXXX. the lower ESA of of composition a extended rheumatoid primary underlying formulation. patients. portfolio, With recently DaVita first XX stable

have converting and Aranesp by from Over size Aranesp. the the last couple of our medium independent years to dialysis U.S. grown EPOGEN we business centers

we aware product long-acting some that offering has their as to of this quarter. lose business customers, competitor these early of As so this as dialysis extended recently our we expect to are

potential if their in also We compete FDA. biosimilar preparing when customer clinics to short-acting are hospitals a including by biosimilar all approved and segments for such the is and

a always Our long Amgen and had. competitive has reliable advantage reliable track supply safety, safety, and that record supplier of is efficacy

markets Parsabiv, U.S. to throughout in Parsabiv continue now the the launch last in includes launching month. Turning new world. beginning cosmetics, to with we This

the Nephrologists Sensipar. the administered available. efficacy could into are it adherence. the As continue level existing dialysis has Since when IV of in head-to-head products level the to compared data demonstrated having was showed the clinical patient’s drive be of line which provider product greater hands an healthcare and controlled during improved the about a positive of excited Parsabiv to

ongoing competitors at some With generic the As to bring our positions. maybe somewhat outlook litigations. is litigation of competitively on given global have to products believe to Sensipar basis. is we market David we execute XXXX the It maintaining that conceivable a although able majority continued uncertain for strong we course share mentioned, point Repatha XXXX in

cardiovascular heart very expedited Repatha of patients FDA This very data. XXXX attacks is of outcomes Repatha exit approval help are its the the important milestone with strokes. and excited and We at risk to high for potential by to

the the treatment. by reductions and year the team further as the first well reduce Our event now speak and can after time of directly for treating Repatha of risk ability first stroke patients heart its XX% as attack to XX%, the with by benefits of to

pointing sales right and in trained approval positive were the receiving are guidance. Repatha days NBRX with still We Our early shortly be related direction teams the It’s field but are pocket since and resetting feedback sales as after signs in the in the reverification are approval, physicians. relatively expect to from first one out as of dynamics costs to similar do sequentially insurance faces quarter Enbrel however the of quarter. flat patient

continue to improve progress. access and We payers patient work making to are

remains unacceptable. at patients. access presentations priority to we high population And The these to society risk risk cost treating looking patients. Our is for large reaching all high improve are not cardiovascular appropriate the of options of

data We the U.S. outside outcomes the having to Repatha also the soon. look with labels forward updated

year In more important forward the previously transition to the challenges would will healed XXXX to volume portfolio driven to the long-term their for I lay and growth. impressive thank Sean? our of innovative pass be world. sustainable Sean. our I And So will patients importantly look as for and we them team our like I groundwork In continue we XXXX. with opportunities. XXXX are closing, an execution and bringing facing around medicines to it in competitive the

Sean Harper

is in dosing AstraZeneca. I spectrum would we reported severe we cardiovascular cardiovascular, have only Xb I the take types. uncontrolled professional study we in and numerous the same our asthma approved more with outcomes expect X with to to efficacy endpoint stroke FDA study in coronary patient XX-week access. a all our inhibitor recent heart treatment approach Good from We In in along prevent stroke Repatha across label is now heart recognizing the life Phase the afternoon. that of the Phase as in X will our Repatha we an patient with and pathways inclusion and one demonstrated thoughtful revascularization to U.S. established note And Tony. to of over and reduce PCSKX with primary payers ability with the Thanks disease. cardiovascular begin attacks, data Tezepelumab increasingly began with in our where of collaboration for patients guidelines events the adults inflammation, X,XXX Phase the broad changing attack. first program

AMG immune reacquired collaboration antagonist our celiac Xa also antibody have cell Phase intriguing We severe ILXX after generated our in disease. XXX data

neuroscience compared to and how receptor elicit approach And pen the allowed is for attractive the first doubts the not auto endpoints submitted for milligram discussing physicians regulators ever doses We XXX And effect. clinical attractive forward can mechanistic a could CGRP with we receptor reduce Aimovig have other not versus in low be sequestrants. asked loading we that we which this. with because us am at and with in uniquely This are maximal are higher development about data providers. Aimovig inhibition the monthly relatively introduced discovery will We antibody per the develop believe path with and and to we ligand having for forward to ligand the amount CGR into be looking diseases often Also only targeted expertise clinic. as doses receptor antibody for milligram succeed potent we antibody an it is are most translates and will in choices Novartis patients maximal with seen option the self-administration wanted patients. area. we the have the month Aimovig much registration the differentiates. the with With regulators injector subcutaneous our CGRP our antibody antibody and the of does they require more I XX potential date clearly to in type established FDA and PDUFA this In May. and we required to

efficacy recently a have angina prophylactic in virtually in with treat, study with We most considered multiple also but Aimovig who dedicated cardiovascular patients of to demonstrated no a treatment with a and not have stable large program with options. executed other only also treadmill failures patients are differentiated study treatment difficult development

data in survival from the The endeavor been ASPIRE updated with was U.S. which the studies prevention oncology survival the KYPROLIS, from positive also Turning for and to Having skeletal a the of two multiple prescribing as data both myeloma. in data patients recently received in XGEVA of overall standard overall for opinion U.S. survival regions. have related new Europe. information submitted recently multiple myeloma events was care for in relapsed the approved established KYPROLIS also

XGEVA increased important insufficiency, kidneys advance Tony often treatment renal bisphosphonates with at patients putting bone the hinders new mentioned, an option. which is is them for complications. as treatment provides through risk develop not myeloma this and an important As cleared

in of We the with Phase initiated care was D-CARE results also XD XXXX. XGEVA. received the study,

adjuvant an publication. in investigational hypothesis, its endpoint events and on of and meet in the Unfortunately, of dosing observed in conference safety with the for treated the patients recurrence could With with or cancer. and/or similar treatment women with bone indication with adjuvant potentially profile. of treatment this skeletal-related neoadjuvant the patients tissues prevention cancer was neutral known high-risk did cancer early XGEVA patients to schedule well-established no early-stage denosumab were primary delay metastases. survival. cancer the will I’d bearing stress events results not trial for breast denosumab therapy. D-CARE explored care as in stages the the has like or bone other metastasis breast medical be breast standard receiving to in Detailed result Adverse to free submitted approved bone future cancer of

from a December. news, authorization to other the update preclinical a and indication. current There with announced the age in to received and to opinion the our X ITP full patients TOWER our Meeting to Phase treatment data We data half-life on opportunity survival recommending to approach refractory others of format Hematology around supporting XX the X BiTE the three of at next conditional conversion the immunooncology provide market for our development. XX had to we extended in months several provide clinic, solid overall both of year in the detailed in regulatory for approval the include received on We Europe from now CHMP the franchise a in excitement have were tumors of trial oncology clinic key treatments X European Nplate or utility other that and to had opinion Finally, in moved chronic BLINCYTO generated clinical older expect American and insights positive programs into differentiated platform. of in these and Society hematologic BiTE a this in developed we positive

to in first in CAR-T We unique place in fact against BiTE antigen evaluate same and have from IND the programs, position and are both we directed the cases, an CAR-T in the Kite our for some Gilead, collaboration.

this will dosing a later patients We bit year. begin

all X conjugate in and Zencor, year antibody Europe dosing submitted fracture. this women as bone our risk our in from EVENITY of In BiTEs increased myeloma moving our licensed of will to which for the MCL-X drug recently franchise, a at postmenopausal commitment our begin well. engaging bi-specific Phase antibody osteoporosis in BCMA UCB and through specifically BCMA also highlighted directed targeted inhibitor; X T-cell against and with X multiple We and men treatment CDXX

with toward in this registrational year. safety U.S. systematically will the resubmission data of in continue clinical the signal to timelines work understanding most complete the our the letter we later collaboration comprehensive observed have in all response We active-comparator the ARCH reevaluate to trial close the cardiovascular under ensure FDA we study. And

continue we good progress European on make Avastin. our to biosimilar, approval our biosimilars of the Lastly, with

arthritis data later In my rheumatoid of would Bob? our for in to X of successfully benefit colleges advancing another programs XXX, Phase the biosimilar patients. like year. year all for the thank of from REMICADE Amgen expect I also ABP closing, We at

Bob Bradway

were of them callers you because a and Okay, up we little beginning of questions portion. the will could thanks. longer than in and that longer my straight let’s just our go to heads to go bit for usual questions Skinner, at me prepared going please our let give remind remarks asking the advertising be procedure the

let’s we to analysts. Skinner, So, from will it. stay questions and the take the jump

Operator

Robyn from Absolutely. Karnauskas comes [Operator And question from Instructions] first our Citigroup.

Robyn Karnauskas

Hi, questions. guys. taking my for Thanks

what when that offset about your of pipeline you help think is biosimilars the pipeline was think And options can the be when probably understand now, the real to you clear for and about you impact? all value in adjusted [indiscernible] looks Thanks. the to are that us can biosimilar how a really you influenced pipeline, And broad write-ins available? value which impact? what really Sean, So, your percentage by about to

Bob Bradway

think to David Robyn, wide you, was was question were unlike but having in one how asking a address, ask you bit of to should your was I that I little range Okay, think we first are revenue difficulty biosimilar. attributable hearing the much guidance we

we think are a lot have to address clear I going that try it related So, to David was it that. make to David to Sensipar, but of

David Meline

Yes, right.

Sensipar. would look the we large the launch, So, competitive guidance you launches larger of certainly, that would to that typically have much beginning it’s at we if about we may uncertainty portion what than attributable that is have occur year. the offered the obviously at year the And a double from the around this of

offer. So, the driver that’s typically the would guidance primary broader than we of

Bob Bradway

go wasn’t but ahead. trying clear get are Robyn, to Sean again, with what was And at your pipeline, the it question you

Sean Harper

very go been we of products are in some you I they are deep Robyn, mean, the we to say legacy at obviously our and have I the that Yes. the it I do think days. right, best of with the the these pressures it’s facing a value had just pipeline portfolio ever It’s versus Amgen transition. on would broad do through as capability expect you that that to areas across X last I can over think X I what a sort the the And really we over same that advancing opinion. therapeutic lot think we respect pipeline we productivity observed that have to exciting years opportunities. we next in, that the can the see with have of my years. the And key observe of focusing is are

Bob Bradway

question. to go Okay, the let’s next

Operator

from question next Chris comes from Our Raymond Piper Jaffray.

Chris Raymond

the taking question. for Thanks

so-called recently to a don’t patient that payers allow patient deductibles count to out-of-pocket and stance a and co-pay really your instituting against in assistance related PBMs take this I this against I benefits you taking with maximums. you I and actually So, could am has to assistance other that maybe some with support the could of question to if are been have some countermeasures From co-pay seemed which other some if what there it brackets that you to ranges regard strong put have accumulators, don’t specific dust year. kicked And have think have could patient. I this the up mostly specific guys ensure read But you countermeasures what some just uptake hoping Thanks. Enbrel, current phenomenon around working measures work?

Tony Hooper

It’s Tony.

respond one. me that to let So,

that agreements You to concept the with access. of we get can’t has sure pretty our organizations their it assist around are these Amgen correct That if the a, disagree afford who the patients systems have contracts that accumulator. co-pays fundamentally, that and with made making we clear is, patients is

people. that So, made put and we in clear writing to it

impact I to because one, quarter business minimal a at Enbrel see look of I our programs. As these

Operator

question from our Porges Leerink And next comes Partners. Geoffrey from

Geoffrey Porges

sort maybe of some all the balance very Thank your of in a you bit that David, bringing little much color there thoughts alluded for sheet, lot the could and on you you Perhaps, are fact a comment question in for cash the and balance presentation. your your moving sheet back. to obviously you

have you the your cash position. that debt given You are fact despite significant effectively un-levered

future a has kind Would willing EBITDA? basis several As for with given visibility flow. the need across look leverage for just the sort the sort outspoken of up consolidation. And to of would your to you at times what be industry, comfortable been opportunities about you Bob, of the wondering quiet on net be go cash you have you

David Meline

Geoff. Yes,

is to the that we sheet forward we So, I And would look last that the and managed lowest average of consideration way the weighted about several I going would optimize how I these sheet cost get at the cash offshore we over think have of balances. did without and balance capital guess balance did the years.

of to over state Onyx varied come think years that since we in what sheet have on a basis, it’s then And time. be about last So, be down would balance to it fair of peak to and think and that had after ratios steady out assume we the we kinds our several those it’s similar the leverage leverage would set I past.

ideal the in that I the large fact given as debt deploying, say be my the to would but such interim, Now, mistaken would we be. structure where of we I think but that that would we capital possible is capital amount very some will quite wouldn’t a that mentioned the what pay be be in in have we near-term it’s comments,

refer carrying, reference the I guidepost without good cash So, just our been to for think years, several these have forward. last would sort over again it’s leverage at the we of look but going manage how a will business we I

Operator

Lynch. comes from Huang Our Bank Ying question of from next America/Merrill

Ying Huang

taking thanks questions. my Hi, for

XX% back comment we in pre-tax your you. question three go a do in guided than can way XXXX for rate then Thank think And you expect bit higher to rate? XXXX whether actually XQ a Just also level saw the first usual, you the for the margin, went tax ‘XX margin you the XX% the about should the XXXX for period? is OpEx long-term David, in tax to quarters a operating the to

David Meline

sure. Yes,

as the reasonable articulate and point, steady XX% but for if of because XX%, at suggest non-GAAP tax that our that, guide use in expense then it’s And QX this discretionary is the level hurricane as in were on I to operating forward. of type to highest starting tax And about those we expenses basis. had level to preliminary we into that the thing, you our them to entirely one-time based related for wouldn’t that of terms as might timing you around I have us costs, which a from say versus you that think I and a typically a sort analysis performance would is correct typically tax well of and expenses we as the on expect such the choices still at are at I rate this if QX going time XXXX the ‘XX it’s QX, know, in basis year was to terms past post-XXXX, basically a think period U.S. in have think perspective. as that at of some we basically state XX% tried this what I year outlook that type we benefit a extraordinary on we be XX% year and the to an recurring look said where one-time expense be had the rate of you extent, that are to of tax words evolving, an We taxes look in in annual our beyond expenses reasonable preliminary So, and period post looked fact as we last year would I got make as at that the rate would to

think year. range as XX% said, the to this expect to suggest be an we margins operate seen and the with of And So, last us the our again average with I over have in to you all of would quarter-by-quarter to that until I patterns you to XXXX you that, guidance XX% at several look what can you years. go consistent expect quite if expenses you

Operator

Our next question Stanley. from comes Matthew Morgan from Harrison

Matthew Harrison

buyback business? here the about pieces Thanks question. got you in just breakout the Great. could the you the of could us you David, performance was taking items Thanks. terms couple help of the impact tax moving that guidance, the help particularly for us XXXX rate I impact since have a the some of line hoping bottom for underlying the think versus of if had

David Meline

Yes.

all, in and terms XX% take to apply would profit. is of you is straightforward I – guess what of I the So, range first would well, the it XX% that I pretty be what think say to tax if calculation pre-tax

I think below a expense income margin what of to the and I line terms gave and both expected you we range be. in operating interest

repurchase rate little more you billion first deployed that total So, will repurchases. terms against. have tax than I as the I And authorization that $XX said, think you the as income you And completion in activity, we that see of apply now hopefully of can for get half. in in pre-tax then as a soon the to know could we

some in that of effects. of if range consideration there into takes guidance course of guidance covers Our our repurchase is timing possibilities terms that the

to I Then can math some guidance. EPS. that again you to your apply share think and get how So, the the count would impact in it’s included

Operator

Goldman next question Terence comes Our from Sachs. Flynn from

Terence Flynn

primarily for wondering built you consider Thanks mergers for or your just on a Maybe during you taking to recent Hi. scale opportunities remarks on example? is well-positioned are larger your prior Thanks. capitalize a question, to prepared the Onyx that is earlier Bob Jeff’s to consolidation follow-up your just if is similar shareholders, you would question. mentioned history

Bob Bradway

of environment. shareholders. changes I the for two and Well, continue ongoing benefit said we are healthcare ongoing pressure in capitalize healthcare well-positioned said address we will were our things that environment there on consolidation we I expect also the from to And the Terence. well-positioned to

being add felt So have that those. interested focus, industry time financial help to that and can we will of create look other to the our we that in in we pockets by implied for some value consolidation around are we deals see capacity are whether in as value for have some looking question we to we the so that the excess And continue in the time part to can of there some we we for been think of that. saying and we areas going are capacity have do consistent

Operator

Our next from question comes Yee from Jefferies. Michael

Michael Yee

certainly no what long-term in Bob you for your kind guidance the that longer worried about are trying sure a Thanks is afternoon. longer Good delivered are XXXX for Dave to that. what there thinking we that XXXX, about I think the maybe term am that about you through of about question. uncertainties and is or get that, term XXXX, people guidance, on there I But XXXX are to need think I people gave strategic you outlook about? beyond to or the trying details need Thanks. Thanks. but factors am think back get are guidance, beyond more I of think When to

Bob Bradway

your both question a Mike. take will We at shot

felt XXXX. are about long-term we there right, different we a from And shareholders. confident big disconnect at you the think be to seem in And were our a I we was place outlook.

we it’s with and growth found and talk business address and But said guidance we shareholders our for of guidance. benefit the as about now question. what continue – we the about to are confident So their about disconnect we to we the I the each helpful get, think us said, potential counsel of see thinking as we that And long-term our excited of longer are long-term outlook to about try term company. take

Operator

from question next comes Ronny Gal from Bernstein. Our

Ronny Gal

Good to evening and thank you questions. my

one mentioned clarification not quick will are see CAR you begin just Just to a looking or if question on are resources then in copay comparison not Tony expect then the see T for the to earlier us of hit the that, in are products that quarter should the costs. or And you have for good program patient Tony in year? My maybe there seeing for it, a a and understanding are to specifics until or some from by how Sean, just when maximum you seeing what late second Do I guys forward to Sean program, is taking the that we impact parameters forward this be you you wrong enough? putting for something we since the see accelerator. the from you against give does BCMA have XX% always XX% those obviously to are good out-of-pocket

Tony Hooper

quarter. And said programs in Ronny, course first of well seeing second patient’s minimal as in see we answer deductible predicting is. and the your I is And So definition to by the what Amgen. therefore part the your the would impact are would question, individual on depend by impact of this minimal as Tony, accumulator first I

Sean Harper

able be to us comparisons it’s respect data. for very be I BiTE than our know set. sort things think With patient generate the important very different CAR and is of BCMA populations going we to and of often be in you to programs, that the our view the patients pretreatment is these this complex, our to that populations demonstrate Yes. can studies this data in And T that

to less everyone can shelf degree So hard. bottom those modality. similar a the BiTE preferred enormous you a of risks and this be the safety if is that that BiTE that cost with take believes would in the in can be that we a safety comparisons talk the risk associated like efficacy can But a be potentially hospital field line that administers of get product the and off with

patient in have both an there think of said times, these I for the individual an many oncology center. As is modalities of even in for I a care spectrum role

Operator

next Raffat ISI. And from from question Evercore comes Umer our

Umer Raffat

questions. we so on decisions have I the Enbrel ask think they to court my thought read three Thanks Hi. year, that wanted from court PCSKX antibody for I on one do to district upcoming taking last much any may, if you litigation. patents across

Thank have XXXX it your is Sensipar And a how much an never which CGRP one how patents way, another there quick is then of I guidance, are is guidance? on non-infringing of question just XXXX instituted, one, on that Second your question finally XXXX this, was entry a IPR seems it’s in you. the formulation. swing like your or in you the aware context, generic and in possible that big a factor so was my

Bob Bradway

question, track the is to you So third where we are there. trying

David Meline

CGRP guidance. in the XXXX

Bob Bradway

litigation, I wouldn’t the it’s don’t try obviously your comment the to that Umer, Okay. read in you ongoing – do on try want…? land intellectual you do meta-analysis two have property question. to I sensible across to referenced. appropriate across we wouldn’t I trials think David

David Meline

this point. to at give Umer individual are guidance We product obviously not going

product. about excited are We the

are difference makes first, interest this but give and dramatic going therapy We you to guidance individual big high, new that product having are about being population so launch point. is the in some not we excited a at a

Umer Raffat

Okay.

Bob Bradway

Yes.

we remind as running limit over Now way the let’s question our audience question, take themselves you one since next are today. maybe to just to and can over

Operator

one question, ladies from next our and from Yes. question And Please limit Geoffrey yourselves Barclays. gentlemen. to Meacham come does

Geoffrey Meacham

much franchises sort priority the a some for question. flow? guys related, return the you cash Thanks afternoon is think separate from mature explored And the deals, of of very how Bob, growth line a pipeline? managing business, early cycle the products Good of have segmentation split have to Thanks. then and to or just when a – ever explored top guys. about you versus just

Bob Bradway

think it’s to looking deals, at on capital and to shareholders. we accretive deals for Okay. both only it’s return find shareholders that to look easy accretive very our is when Geoff, return our are find deploy on are that to the from, so can for focus we deals we capital very add long-term we our hard

regard. we question, are be respect six record are We areas I going track we And you So again continue in disciplined. second in. our know to that the think know with interested this your to

very looking value been create focused shareholders for will do we and at ways have We to very to on our active and continue all that.

Operator

comes question Cowen next our And Company. from from and Eric Schmidt

Eric Schmidt

Okay.

for price, decline on it gains math Slide you is net question and had, there? provide XX like that and Thank a what’s sales Just Repatha’s volume be XX% a that would Tony I Repatha, you right color some was looks can on doing is maybe am there going true in on quarter-on-quarter the you. the

Tony Hooper

give have was on details one that. can a net to high. Yes. I actually I come was with details back them to you There going me. the and give that change you but in couldn’t don’t think you now. I guys We that be right don’t the with price, that it

Operator

Our next question comes Suisse. from Credit Alethea Young from

Alethea Young

Thanks would for programs there Great. anything or that my additional anything are for consider taking you Tezepelumab, like One things? question. X maybe Sean, for Phase allergies in

Sean Harper

form we it the aisle of And that synergistic address Phase CGRP could will in don’t X know that X patients to cells with Phase The they that Phase study migraine, BLINCYTO, this our way into to next for with with now, in a of in programs of we excited you Treg also respond in as Right kind I the strong I are that fact affect of new that’s a autoimmune innovation. mechanism And about the X we where in and number be are moving are disorders. AMGXXX, leading was population as AMGXXX a position see would program multiple Yes. program profound for is the either may mechanism things CGRP engineered to IL-X. are BiTE to or think them it highlight registration hope that while are is in a like enabling. are able have which team be we

X, Phase this the line blurred area So particularly. oncology X, in X pretty gets

molecules status. inhibitor are the I be next the that as type MCLX a potentially including of clinic in So of lot the study consider to a pre-registration in our study

Operator

And Kasimov Cory next from comes from our question JPMorgan.

Cory Kasimov

recent, Thanks I for recognized Mine more question. Repatha Hey, really good and afternoon is but taking missed guys. the it on little I it’s a color.

from still field label and really a of the in to payers like the sound importantly you and more the are a time? the guys payer aware period make this label On expect drug of early of make longer you Thanks. you CBOT have feedbacks how given much data it the getting difference been the on access issue for the that post inclusion it’s of

Tony Hooper

here. Tony So,

Let right. one, me respond to that

I a LDL probably of lower the product physicians promotional a which risk Repatha XX% have being to a talk position since real attend from to LDL So, able able don’t of perspective, of heart physicians have we to we have times, benefit our the couple as out said to talk large about not been launch, is reducing stroke. about in of thereby attack the and congresses, able who lowering and be to been dramatically

positive, very have speaker sales been never are and the where programs, the feedback label. to-date new of By has they does. approval the the Thursday, an the moved, the NBRxs, we – higher this weeks of got seen Friday the actual the such we from trained an understanding we to program rapid the By what cardiologists, week, And X managers from talking from XXX drug speakers of trained By people promotional programs Tuesday, a XX when value fast force about program. speaker had specifically on Saturday, exit the these are material. two promotional team by XXX trained XX% at has Just people about completed just of the December. for next The entire attending cardiologists of over on had force. sales than speaker I with and average we XX%, you XX:XX uptake average idea how look our give the they I last each not an of average are at truly a.m. about speaker weeks entire

When the seeing of I of terms read patients yes, at or I So, improving have this early an getting in of X% about by are payer but it’s January to commercial see tough sort – the plans our approved. on, uptick getting XXXX, approvals. are improved to we new in look access environment,

Part Our XX%. has by improved D coverage about

drug. to we hard the this make work of understand continue to sure So, people value

them I think get patients for are more to and drug. more appropriate cardiologists putting forward fighting and physicians and on the

Operator

our And comes Salim question next Mizuho Syed from from Securities.

Salim Syed

Repatha. Yes, one my I just hi. Thanks for had guys taking question. on

Thank specifically it you spoke So, Day be And that. inclisiran is thoughts and prevention Eugene a and at relates spoke Investor between Repatha? specifically was any inclisiran. Company The to recently if Repatha your I there as that can also with think curious were on you. impact primary Braunwald inserted regarding what Medicines do to statin and

Sean Harper

Yes, try hi, I this is Sean. to respond. will

we broader although than perfectly risk both study been primary Europe a be in years, populations these identical I the kind to that think the reasonable our kinds the statins think are high-risk very it’s that. U.S. on addressed and obviously with the prevention can label population, with high secondary is that agents of patients. that And prevention over of have treated focused type populations I to

drugs were OUTCOMES difficult at we would it’s another LDL. situation trial, experienced to I reasonable very to look a not the have multiple to However, when thing who go I the so do sure patients now I levels high get going events and right these faced do. it’s have that’s to strategically you of where am if but direction that

the siRNA from effect is with that safety a perspective achieved, in efficacy of broad be on can The safety population. sequencing depends bar of like platform terms mechanism size all high if profile obviously extremely the the these Repatha. an therapies, technology very that of In novel

Operator

Ian comes from Somaiya And Markets. from our question Capital BMO next

Ian Somaiya

my Thank you Repatha. had one question. another for taking on I

the a previously to CVOT guidelines reflected once I of speak us just to forward? of in the recommendations, and from we willingness am have standpoint, or pricing commented have once that price You gotten point. PCSKX we for room much with rebate the maybe are on with negotiation was how rebates is then going negotiated separately sort label, to curious I see And on in structure where payers changes there pricing the the payers guess

Tony Hooper

So, Tony. it’s

this in the that we marketplace pricing levels to the the around So and providers the as about are debate improved have of and year, we of last access. payers have value-based constant discussion talked with being value are and drug, we in ensure rebates offered

not position the about one. get So, can an appropriate utilization we I a going management just think improved with don’t we with to we and ensure improved patients that that the a as on afford payers basis we dramatically, every on Quite forward. plan is stop unable to go ensure able fundamentally And criteria that good formulary on with that that we ongoing where to they to deductibles for to hard continue work to has we worked assist work afford. or with have co-pays while on have are

Operator

Next from Andrew comes question Peters from Equity Deutsche Bank Research.

Andrew Peters

taking for thanks questions. my Hi,

stamp different as new broadly a to manufacturing perspective made you topic to is into for that fit you Amgen you. that can well? bit maybe general, you the your of on think guess side, a And how switch about potentially basis slightly as as I So, margins? next-gen biosimilar could strategy in just as and biosimilars, margin then pricing talk a more about see do by think think if on something the and from the Amgen gears just impact about Thank competitive franchise, is on a how technology you wanted this kind production differentiated biosimilar

Bob Bradway

this and Andrew. question, can I in respond David take two We your parts. to

been for some time. about you respect manufacturing, have with this First, next-generation to as talking we know

lower across and generally committed we Amgen. and again cost some our line of said and ago be still in that competitive as to would clear delighted consequence to we operating benefit have And Singapore. we first reflected excited years about first of over a are have that talking – we the source meaningfully sales We lower happen. time is a regulators are capital costs And the we both were approved that believe facilities global of these and that at that expect will we advantage a when manufacturing

biosimilar we of medicines in track will the and particular think every have We to be every the reliability biosimilars, when time a supply from supply Amgen record a of of reliable supplying and differentiator. safe patient comes it

David Meline

thinking would current I first the going margin be next-gen just set on we to add there and number is we I enable us think of to as our competitiveness. journey against contributing of continue caution and to right because our of helping would I structure drive about when next should Yes, in us this module were from step about place Bob operating think to achieving this we will big terms up a that I operating to in manufacturing own very we now out nice that are module a guess are things the you a us now, that certainly to get talked talked competitiveness. is our where

continue continued support think are that very in patient particular in enable these products our investments going cost then and so us driving to population. increase to new about down of And large after

driving business. So, cost our growth we are for to base support thinking heavily allow of in the invest to about continuously us

Bob Bradway

as Skinner, let’s East more it’s please. two on Coast, questions, X:XX the take nearing

Operator

Absolutely.

Carter question UBS Our Gould next from Equities. comes from

Carter Gould

in. Good guys. Thanks squeezing questions me for evening, the and

list in the are that have question indications rest portfolio excitement, proceeding Is focused inflammation. you we follow-up assets, terms the of we the relatively of go relatively your Sean, role to more the or approach all seen mitigation agents recently expect of in broad risk on because For given of indications narrowly despite of central inflammation in earlier should expand? that

Sean Harper

that asthma without we patients unmet average by to given fairly that profound a in need that be to good office. agent the to that a of difficult could having I would is complex and it’s Yes, in sort is question. particularly of all parse are for I level what mean, criteria clinicians say assess believe there comers a

believe therapy personally particular is biologic I that like area an of tezepelumab. for opportunity that So,

to get to studies am as the I are possible could the kind where a variety it other COPD, ideas believe this think sure likely and these profitable and like that or more an of that one of nature and represents I indication, continue nook inflammation with to And of product because in all like in inflammatory very cascades that. explored idea be disease some the are atopic cranny work. asthma efficacy we there core have by explore. it a of more in substantial virtually if therapies so mechanism the once areas Then might has every good might another anchor at not trying other that every good that setting products and downstream a of that find directed the opportunity space product investigator-sponsored dermatitis companies a either

Operator

last our Markets. from Capital RBC comes from question the And for Kennen call Mackay

Kennen Mackay

there therapy of a there years of Kite, thanks in like ahead? up it Hi, and the in-gene balance and the seen what have for to wanted perspective some like of One on micrometer for like you was editing taking have was there mentioned sort on the a supports of what the of converging really sales exposure the anything therapies grow question. and business strength interesting? to view lot you as a programs. of space, not the now here. mentioned out some T or Is really Bob does sheet really moving Repatha, building volume focus a David, the do Prolia, consolidation gene Bob really a now Gilead get Aimovig, transformative We just you like with capital of CAR surrounding owning that like that sort couple positioning sort David you in or and there that align

David Meline

this Yes, particular establish we commercial there What have six comment would clear is the think focused are I that on of we terms areas, in I the I have been on in pretty decided to presence. out a we guess, opportunities where Meline.

size tend areas want everything we see across want that towards And to opportunities Kennen ourselves the we be us might that to clear and of would and so of market but to those interest are on maybe that quite to those any certainly…. in technologies, orient we comment Sean

Sean Harper

platforms of just of will mentioned I it more the we things is are, capabilities we because felt and areas, you Yes. there them like that therapy in earlier No, a of these would since for at purposes bear and scientific is six emerging manufacturing that our could look or gene we one gene-editing technology even therapeutic they aren’t the these some opportunity these so kind if and commercial emerging on. breakthrough likely bring to

that those of kind shown have on We move will things.

Bob Bradway

think question, little let thank and good me But tell from us. are heading that did you job up, I just to to Kennen, again than add our so we it, longer you Sean as remarks. than can from all think a answering a the into just call XXXX I David usual Well, wrap Alright. rather forbearance and went

We are the we operating excited are think well. business we

We have strong products.

are We we focused our shareholders. rapidly. think well-positioned that’s value delivering growth have on for an pipeline we attractive advancing Strategically, and and

through So, we with the look do how quarter. in Thank you. we to all first and reconvening see of forward you April

David Meline

And patience. a I we’ll and several had to to between of topics cover for gratitude would We course standing lot hours. your team be myself my for today add my of by just like

any have you feel if questions, Thanks to call So, free other again. us.

Operator

conclude call. today’s This does

your disconnect. now for may Thank You participation. you

Amgen (AMGN) 2 Feb 182017 Q4 Earnings call transcript