AMGN - Earnings call transcript Q1 2018

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Operator

My name is Inn, and I will be your conference facilitator today for Amgen’s First Quarter 2018 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. Inn. you, Thank everybody. Good afternoon like for to our would you welcome first quarter call the conference of I to XXXX.

driven continuing I think new deliver recent products with Parsabiv. solid a our volume launch to of we are and off recently to growth most including start launched

notable look also action like FDA forward our have We for Aimovig to, upcoming date for catalysts to migraine prevention.

Operations, our overview Meline and the and guidance discussion Hooper a dig review strategic the for Head Head who XXXX. Tony lead our by who quarter a followed out Bob David of today of during Global CFO, will performance provide followed Commercial Sean Harper, for Bradway update. will will CEO, our product provide Our R&D, our into pipeline Chairman quarter, by first results will with updated

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

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

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

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

Bob Bradway

for Okay. Thank us. joining all you, Thank you Arvind.

earnings new including recently in product of XX% us solid growth had XXXX we're a X% XGEVA. Prolia start growth per Repatha, growth and can our double-digit We to see, and all unit you As products leading share. in in launched KYPROLIS, off in non-GAAP to sales with

some medicines address clear volume soon needs. growth real of U.S. innovative These will Prolia, Repatha, faced brands legacy have drivers strong where that of competition examples generated and Aimovig growth. the of are long-term our be time. important outside for KYPROLIS, also We XGEVA unmet our

R&D medicines to new our continue clear stage and tezepelumab we of changing molecules develop for to and invest game all propositions addition, value mutein patients omecamtiv, have In which IL-X in society. potential in the like earlier like

biosimilar broad solid patients BiTE recent platform is disease molecules with migraine first-in-class to ready In approach to in which residual first neuroscience of prevention. a immuno-oncology We confidence the focus cancer need the for physicians turn the for do Aimovig for liquid Current Aimovig, of long. in to up forward to and this unmet not debilitating therapies launch gone fruition adequately AMGEVITA effort hope come Humira under demand better too a relevant is see internationally. will to as U.S. disease pent quarter payers urgent redefine our The promise this number the minimal with prevention biosimilar our and CGRP across addition in for BLINCYTO in patients, given launching treated and into antibody in this and Later Novartis our migraine our for year Together, a therapy ALL tumors. in for and coming gives our pipeline. under looking approval begin appreciated we both this launch we we're therapeutic, We're disease. us of is address migraine this to

create to worldwide. leverage to quality opportunity compelling to a our of biosimilars and high reliably have patients supply decades We biotechnology experience

for first biosimilars cycle approval our for approvals plans the has of AMGEVITA executed receiving gaining a many we While regulatory biosimilar to in MVASI and successfully have Avastin. challenging field, in proven

products Herceptin biosimilars as globally. begin May the for launch on an We U.S. to us biosimilar have our we KANJINTI with believe in next We opportunity important approval our for be our of can opportunity growth XX, version

enabling in us strong Our our long-term and flows return growth balance opportunities innovative shareholders. sheet and to to to after invest are cash capital tax

the and the innovation use our cash investment launches be while build for priorities to in continue of Our growth of our presence. to products out supporting global continuing

global announced we manufacture which Island, will States bio in in proven highly is generation employ generation a capabilities new to U.S. and next its manufacturing United the bio many the tax of facility skilled This next products manufacturing plans new build Following state-of-the-art result of first creation reform, the plant, the jobs. which will markets. Rhode for new Amgen’s and in kind

for we with return As areas opportunities look for that path are shareholders. about to to of our the continue development, focus remaining innovative disciplined for consistent strategic our earning business while

deliver our thank our around look patients the also modernize staff Congress track returning we've with to and it plan through ago, raised as work world, that on business like important environment, over ways buybacks I today capital significant the outlook and the our this share Briefly policies We future year, excess that closing, a strong coming the and the those, affordability capital and advocate to programmatic to and record year. shareholders. we strong which let undertaken In continue the at to as have program. Amgen XX% me seeking returning all remains let political to say me while Medicare to we continue months, will constructively maintain. addressing for administration weeks our improve Since dividend access initiating medicines our we to have average into new of we for of a years while shareholders, which seven just

to David. Let now me the turn call

David Meline

Okay, with thanks Bob. our revenue and solid growth quarter. in first pleased earnings the We're

growth during of of As our time transformation, efforts investments support continue to a transition. portfolio driven enable in volume

at results, Page billion year-over-year billion deck $X.X sales in grew new our outweighed quarter brands. X% $X.X X, declines the the first first the grew at demand as revenues mature for products to year-over-year. quarter Worldwide unit the of products worldwide on in in our strong slide Turning X% financial

transition bio XXXX due in income of number innovative at revenues quarter. we milestone years. market prior are related our experienced We encouraged million million volume the from by first for $XX decreased growth portfolio where year. at year-over-year X% a products particularly, billion offset compare a Other QX our year-over-year have higher Non-GAAP reflecting for value to in and $X competition $XXX XX% Europe, of in grew income in partially this by of operating QX received operating Non-GAAP year. of XX.X% margin the an royalty unfavorable to was payments similar

expenses. is year prior in margin the our As timing operating quarters years, of in the by lower to remaining expected of driven the be

and unchanged the mentioned sales lower sales an As is well improved by $XXX as XXXX by non-GAAP products basis, quarter, evaluate of value. shareholder and in first in increasing investments drive products by manufacturing a QX of royalty costs. points at year. to as years. percent XX.X% and products quarter incremental X.X driven consistent continue lower in opportunities to expense our we last versus sales partially last Research maximize Research On at of growth development of with as to XX.X% cost pipeline were offset previous relatively as and percent million, expenses a development external

investments XX.X% similar those X% or research exceed non-GAAP we expenses, to share. of and to launch development expense our capitalize shareholders. due products, is support build Prolia year-over-year potential. to products. remain as percent billion the around X% bio our U.S. we expect operating provide out returns levels QX. quarter new per track products, as for increased share the at to greater SG&A Aimovig areas on our a to on year-over-year X.X growth X.X bio its continue percentage XX% decrease rate and driven traditionally invest increased the Similar forward, in This the basis federal to a expenses and is tax on the and XXXX. primarily preparations $X.XX first SG&A Going and quarter X%, first Reflecting to lower our our presence earnings million and quarter R&D a new our year-over-year full of in similar expenses tax basis. and savings by transformation in In therapeutic to QX addition expense for launch while making rate launch normalize unfavorable levels. sales net a to meaningful to a aggregate in income year-over-year, sales savings, of XXXX non-GAAP Non-GAAP non-GAAP expense is lowest per by net on was to advance normalize full products year point increase Other commitment XXXX statutory above we $XXX the In were business expected of increased XXXX and in income versus to for $XX reform. the continue and million, global to increased investing The profile

for in levels. the higher the was QX quarter sheet would next to on Page expect net subsequent X. as expenses of quarters income cash somewhat cash normalized billion the to flow and year Free $X.X from the reduced balance by be free driven for we flow remainder cast flow Turning

paid earlier the this addition, million, QX cash installments represented This In impact we eight payment cash tax. first of month will free repatriation of flow. annual the which our $XXX

to $XX.X shares million to repurchase billion to our cash two XX.X QX to in four returns our in provide repurchase shareholders significant with of incremental we as continue consistent billion We commitments QX. an deployed plan shares. to We

from per $XX.X year. last Additionally tender auction decrease over in QX increased the cash same in reflects addition by decrease last of increase the billion, Cash our the totaled This months first dividend of share, quarter free quarter of period. a our successful generation Dutch or in offset $X.XX an billion in buyback investments offer over significant twelve $X.X past during our to dividend that XX% year. of first execution to deployments flow approximately

as rate maturity and stands Our at average balance debt an weighted carrying interest years. March XX of of X.X% average a $XX.X XX, of billion

Calcimimetic our on for support Page Build to our our non-GAAP growth our XX%, implementation long This for $XX.X We competition our portfolio. the with potential the a in of XX.X% Today, $XX.XX previous in in we our to prior tax spend billion. populations. and for to we across associated $XX.XX. XXXX contemplating continue to on reflect of the Further, guidance favorable potential are business large non-GAAP versus we prior versus Neulasta new QX sales Overall, $XX.XX to to we guidance to reflects $XX.X increase Aranesp. outlook with guidance, out as solid well revising revised of performance year-to-date XX% revising outcomes have to are as share as items as to revising to tax $XX.X the one-time for guidance, rate Turning guidance as versus volume plans invest At the tax $XX.XX of our range same XX.X% track the $XX.X earnings global are outlook. With and Sensipar XXXX some guidance time our and patient presence is per which pipeline. regard reform. realized the continues to competition remain a to term generic outlook revenue billion of of growth billion X. XXXX billion guidance revised well

continue of turn this We expect to capital to over approximately the year. This financial million concludes the update. call I Tony. now expenditures $XXX

Tony Hooper

afternoon and everyone. Thank good David you,

our on product XX. find starting You’ll sales number Slide

Our at off to to a business, growth, we about to continues populations volume total double volume all as The products newer large targeting continue medical with growth. legacy products patient the portfolio as solid driven some more digit this grew start to year, to We're growth. with innovative the of unmet of shift X% our delivering launch brands, needs.

a growth grow more In number our to trend quarters ex-U.S. newer markets the exchange business our many of These the rapidly the overall for impact X% growth a company's of excluding been model, the growth experienced of markets of volume by last portfolio. of for the majority growth. brands has decline our As a profile. mature demonstrating we've as X% foreign continues generating potential already serve fueled future ex-U.S. of

migraine deep the for and in portfolio. of ramping investment teams year. sufferers launches in upcoming place preparation first up the are also our the majority A the trained levels throughout and subsequent of bio-similar for sales Aimovig We’re continue and will

performance. Prolia, volume. leading osteoporosis XX% Let from brand year-over-year grew me primarily to turn therapy our brand now

as well osteoporosis segment, postmenopausal rates. patients, Prolia. in We share improved of This drive realize physicians repeat injection growth benefits patients increasing an and continue the as to new as of results

Prolia sales seasonal representing As a Overall one penetration and either exhibits with quarter sales, and diagnosis is improved a still three reminder, this significant increased XX% a market profile and six quarter dosing quarter very the an low four. two expect for unique through a given we With treatment. month in growth driver. interval Prolia and potential lower remain indicating, than investment will pattern strong

second treatment U.S. by triplets primary all Kyprolis line year-on-year the In Let’s in the Kyprolis regimen continued to share lines majority room from oncology, move as line with in business. now Kyprolis myeloma first the the of shape the The market has driven defined to usage in growth Kyprolis. our is to grew has in and starting Velcade. ex-U.S. market quarter. XX% but of overall multiple stable take the second segment. Europe grew

remains to primary Kyprolis. physicians will actually live when regimens year-over-year focus message that from Patients clear. treated have Our who longer with XX% XGEVA grew volume. include than relapsed

more optimal comment not oncology early physicians anecdotally $XXX the with are benefits It's products and of and brands myeloma. Although in The IMLYGIC XX%, Nplate, clinical BLINCYTO, BiTE events teams positive myeloma which million other portfolio. should is cannot Whilst let was during growth our of as up multiple in in buy the we primarily the multiple have growth receive by quarter. skeletal-related our the the XGEVA’s Since that on burn our we're Sales [indiscernible]. days first from label XXXX, but combined the providing to respectively still January institutions many from half slide of with some XX%, XX% patients preventing with buy BLINCYTO me emphasizing pleased than from benefit particularly off is been XX% of volume by sales feedback on multiple into these at therapy product our a this Vectibix, quarter. performance a driven exceeded growth I'm quarters. in believe over platform. expansion a we coming myeloma in receiving patients and

platform. about from more this other well Sean from as views as the on products his emerging hear You'll

agents. Turning as use we to the continue X% now Neulasta. Neulasta to sales decreased chemotherapeutic decline slight minor a year-over-year in see suppressant of

burn a second small little in quarter. also off the We saw blind

utilization We those exited technology adoption lower share. further of continue Onpro and to a to market U.S. underscores rates the convenience hospitalization of values in quarter U.S. patent one Onpro’s febrile neutropenia. the drive of at patients and and providing the XX% due for protected in

We global to in more see expect on utilization XXXX. Onpro

Onpro are we a of recently for Opinion in in reminder in As Europe markets. preparation several CHMP launch stages received positive the late and

in quarter we XX% competition. market For is the short effectively to share acting just the compete of exit plus market of as This facing NEUPOGEN, holding after under one. years U.S., continue four we

higher market recent quarter that some trend resetting disclosure with the growth The and Moving with selling stands re-verification – assistance volume versus quarters to during quarter decline Enbrel, net XXXX. XXXX and now quarters. patients of Consistent pride contrast to latter growth to deductibles sales trends experience year-over-year continue one Recall experienced of consistent expect which resulted one class slightly our to a with in declined price X% to patient market to quarters. XXXX. break in in late relative insurance we

provides. and positive of delivery ENBREL While innovative, we’re customers both has the launch early feedback Mini days, excited met patient-centric this patients system and this opportunity, with AutoTouch with very been about from

patterns or quarterly purchasing supply fluctuations. can final cause the ENBREL As note, a chain for

increased Recall as broadly mid-size our DaVita. that primarily provided remains lowest the of businesses quarter competitor ESA of lower through the with year-over-year over a expected seen percentage net different for the to declined composition declines, in one. our price are quarter long-acting with underlying competition. Unit year previously, while consistent a the based those of last quarter provides declined supply the evenly now small year-on-year fairly extended product a on stable, the demand the number balance shows lose with selling to one had volume lower expect distributed of trends one a and EPOGEN XX%, XX% of extended we centers. selling we portfolio. that continue a of the rest more their year balance the we those into Slide then XXXX slightly year. disclosure noted Switching to early the Aranesp growth to dialysis XXXX. with As represents recognize result one And for as XX% business quarter quarter of some XX quarter X%, unit year-on-year, ESA price, relatively we agreement net segments.

have to oncology by share We an of biosimilar with the also if in volume prepared on short account compete to customer continue and including segments account acting based when all we'll some clinics, We're compete for and hospitals the contacts biosimilar customers these basis. by potential FDA. and such approved a and is

Our long supply advantage. record reliable a competitive of track safety, efficacy and is

off Parsabiv launched U.S. to a the including now to and several strong in start. cosmetics, Turning is we've markets

patients of of the As head head of the during uptake dialysis available. Sensipar. eventual puts administered so a hands this IV to product provider, continue in the have dialysis health level adherence, the Since far could when nephrologists control are determine to line in pilots level positive to continue free-standing protocols. drive to compared and showed, providers. demonstrated which in about midsized clinics the dialysis, having In treatment excited the existing data be improved we U.S. technical larger The it run Parsabiv to also an care greater it’s efficacy solid a the

to over see increase time. gradually adoption expect We

Turning now year-over-year to XX%. where Sensipar of growth

believe directly the interruption. patient As provider Sensipar order of B Part D the also the whom changed the providers most receive to supply during the more altered in mechanism one pharmacies. the versus supply to from patients, chain a XXXX. Part It Sensipar treatment reimbursement reminder, of potential now ordered dialysis traditional for beginning We U.S. minimize was in quarter in additional for from

should quarterly and chain to account believe Parsabiv. exclusivity rates, into some run more that transition also and the supply assuming is historical take continued new We to return now normalized volume

It market strong have still bring although, With some Repatha to that on basis, Repatha, is position. able believe global we somewhat our competitors a uncertain to litigation with be products of Sensipar XXXX to at compete the mentioned, ongoing we for a in given litigation. XXXX, conceivable majority share data may effectively generic label. David course As maintaining is outlook outcomes we in continue a point the

Our Repatha XX%. risk utilization from of heart to rates directly team U.S. criteria ability and treating has attack primarily in improve XX% the of with grew benefits Overall management the fulfillment volume. year-over-year, and been its patients to reduce continue XXX% Repatha as to by evolved. by speaking stroke

risk and Over expand seen offering offers to access months remain negotiating access ensuring to discounts access the we improved for committed several continue Repatha high patient we've with past months Repatha multiple to patients. to be payers of to We've few affordability and been with significant cardiovascular spending. and

As addition a PCSKX inhibitor we FDA of with for possible the baseline best including LDL The and that XX in the Repatha. established levels new to treatment approach strokes market disease, leader, offer patients to low a LDL the majority attacks PCSKX per prevent prescriptions inhibitor heart milligrams with approved lowest in have treating patients only is demonstrated deciliter. ASCV unequivocally patients level as as as by

patients. the remains high Our labels the and of unacceptable cost U.S. access risk not in appropriate updated priority we reaching treating having and to of into population for patients the improve we expanded these patients, society outcomes to options all large outside data risk of high look look Repatha soon. The with forward cardiovascular the also

compete. mature brands us new transition of upcoming as we of some our by A majority our growth confidence as finish what ability prepare in me with a Let to the This the portfolio performance in countries brands grew U.S. demonstrate I as continue we proof for double-digit, outside point. to our volume-driven gives our launches. as exemplified many performance well started, our to ones

XXXX. and get hard patients thanking work start by close the so Amgen’s that important me staff the all let So these strong for to to products to

I’ll pass you to Now Sean.

Sean Harper

myeloma. indication today in promising. milestones multiple a afternoon. related Tony including skeletal recently then decisions comments the stage with a I'll key good prevent received some highlight regulatory We with Thanks my events particularly from brief several for and QX XGEVA we patients few in of approval early programs innovative begin overview an and find expanded important Europe,

other meaningfully include shift residual the approval employed of diseases responses. received action would several of X we clinical for are therapies outcomes cardiovascular after remission lymphoblastic orphan potent the marketing in authorization in next XX% a treatment for molecular first is are ALL opinions cycle presents designation and children and This appropriate. residual factor gratified MRD precursor the field. MRD. a the our and all leukemia as suppressant. A including date accelerated Onpro in treatment from study allow detecting disease also now therapies our And MRD kit States, This durable technologies approval prognostic extremely our at the recommendations or develop a We in patients complete for advanced in BiTE MRD in the PDUFA single for FDA also incorporating our such that that data a for oncology studies Neulasta and There we're month the to CHMP to deep minimal patients being label that adults received with KANJINTI, has of Phase for is Repatha into with and U.S. were step of the relapse disease ALL was MRD, for of a strongest variation also we're positive KANJINTI, drive and for potentially biosimilar first of paradigm exquisite label. continue of United MRD to were in positive the BLINCYTO. sensitivity the BLINCYTO therapy I ALL as are approval whether treatment negativity that Herceptin, by in achieved our B-cell addition not but the that only note the acute level

the lead talk For there time, and and is the excited diseases fatal actually been to of we're achieving way. what first cures help have

disease alone. pathogenesis that cases ALL XX,XXX understood in key the highlight AML, early affects antiapoptotic of the this many a at The with for members BCL-X Phase MCL-X are Association new our four as X American several assets as a month. to data and the refractory BCL-X roles Cancer meeting is our from monotherapy acute in activity multiple and market myeloid agent opportunity the to Phase the AML have AMG and with of A X compared approximately and We At play myeloma the inhibitor preclinical States grievous people currently venetoclax relapsed leukemia year to enrolling family XXX of promising in settings. we XXX times study Research or as United in either AMG potency preclinical XX,XXX alone presented AACR, inhibitor deaths data patients. improvements MCL-X and per showing combination of or

also our of all have to the to to restricted of that cancer Despite BiTE to antibody DLLX two target and or clinical CAR-T potent advances which with antigen expect is XX% accounts target in modalities XXX developed cancer. anxious we've disease DLLX very targeting an enrolling this will half-life compared and both developed CAR-T in more or AMG we Phase to DLLX, of DLLX very AMG been cancers. KITE be traditional in drug a if very or for is the really exciting to there and begin discussed the testing. XX% with soon. enrolling antibody this, outcomes We're XXX We unique X aggressive lung highly approaches patients effective ability see effects very for technologies, its believe expression extended immuno-oncology lung poor we small small decades. cell with conjugate approach. lung no And with –BiTE significant about disease cell devastating treatment currently

from number for of in our metastases. combination Phase hepatic injection BCMA the And types BiTE X meeting AML. extended At Phase with XXX for into Society now with carcinoma we're of of myeloma We CAR-T Interventional tumor Radiology AMG liver safety our study IMLYGIC. hepatocellular we and in KEYTRUDA X and also data in a half-life moving March, presented FLTX presented our program multiple preclinical characterizing data

have of activity. where these BiTE are programs myeloma encouraging than in seeing to molecules, there BiTE for collaboration our potential been XXX, data more and solid BCMA some clinical CAR-Ts underscore a We're our early BiTE to particularly with multimodality the our XXX, advancing interested and immuno-oncology clinic platform, we've Kite. currently stage tumors three the BiTE CDXX antibody, dozen at from continue seven in very from for being day the AMG forward for We and Neurology through Briefly AML PDUFA by work American receptor approach Academy IMLYGIC, early May to AMG today Aimovig, and All the already to look XXth differentiated our this CGRP on addition toward we the of in we're data our are our of to a patients four Aimovig across FDA year. end presented with to two in antagonist with action multiple evidence those spectrum results migraine for migraine failed treatments. the body naïve therapies. who These of study from who through unique previously preventive our multiple failed have of consistent treatment patients add initial in the

auto minutes few one suppress immune Finally, immune an the spend a I'd for therapies inflammation like our system. to of on early programs, XXX, AMG current diseases IL-X mutein

this IL-X paired recognition medicine but Enbrel the responses as is self a associated In Tregs multiple administration. state, dominant identified human receptor. diseases. factor AMG preferentially cells form, Treg an normally In off T an the IL-X growth balances that the XXX, in diseases human mutein practice having balance significant designed in the effector within unmet favoring effector genetics. been it toxicity such extended binds life between by including has autoimmune we’ve system disease with IL-X with its many therapies immune to have in changed half effective for With through remains of Tregs native these cells. maintain is regulatory significant the for need approach regulating this of non-self negatively cells or While functioning and

dose proof-of-concept we of So Phase as in to was increases volunteers and single dose initiated growth dependent resulted Based Treg on Slide American promote well versus in host Xa in exciting showed in that cells Hematology a presented we've rheumatoid as selectively on lupus and graft effector data XX. year's AMG Society systemic disease, XXX shown Tregs in and meeting, increases these studies function, already chronic arthritis at last tolerated in with erythematosus. graft, results, healthy minimal of

be could break-through XXX powerful of potential this very number to quite We’re want our dedication I a the for AMG about Bob? their In the to thank patients. of developing excited for diseases. and staff inflammatory benefit for approach believe that closing in medicines

Bob Bradway

Sean. Inn, turn procedure to remind question over of question. and our we now you, for time Thank our the Okay. you callers asking perhaps could

Operator

is Our from Instructions] line Barclays. of from question [Operator Meacham Geoffrey Certainly. first

Geoffrey Meacham

from I the a to scale could close the learned the kind from a lot we’re launch. how us if size you maybe PCSKX of And migraine to reimbursement for Tony be and the competitive. help maybe guys. are with commercial for Afternoon, it’s organization. the of know you. the you But Thank to you experience lessons question. I Aimovig, look and Thanks see launch the when perspective, what realize

Tony Hooper

try let with Novartis. the medical we the of history a presence are in it answer Geoff, together me going Novartis salesforce neuroscience organization. of and market, have in terms rich in ways both outstanding market to that and two an

the complementing From to we We severe care teams to PCSKX both follow. or a are specialists unlike a as the forward primary perspective, with headaches have with We had calling as physicians in timing migraines. the patients We look on after of first it some situation. to well clearly look have lead. who propensity launching

being this the of patients not We will actually have actually know And a where market in symptoms sit they’re treated. cells. huge is when price and clearly properly

we forward patients large drug look as quickly dose of So of this want as come possible. to to a who

Operator

the line question from Peters next Deutsche from is of Andrew Bank. our And

Maryana Breitman

those technical questions. like the Breitman moves, Peters. what individual strategic an or [indiscernible] see thank new wanted for products capability about or Maryana Andrew a stage to for possible guys, taking be? do you Hi products I you and ask would Yes. platform

Bob Bradway

line was up. Well. I’m your breaking phone afraid

Inn, So call. and want bottom can’t this towards maybe to time try Do recycle we you the end we of can that repeat her if hear the then at question. to couldn’t hear you the

Sorry, won’t hear let you we try see again, can you.

Maryana Breitman

hear now? you me Can

Bob Bradway

Not great. Why help on the and don’t in our Inn get back operator we to get you different a line queue. you ask

Maryana Breitman

you. Thank Okay,

Operator

All right.

question from back Sachs. line is While our recycle from our the of through, Goldman Terence Flynn next

Terence Flynn

the particularly us latest on we’re your on prior the of the referred some the just in Thanks on I system. side light taking question. for the lot. can consolidation the previously there update Bob was thanks Hi, access of services of of I a in if seeing some wondering to industry. you calls, capacity thoughts you think

Bob Bradway

Nothing new Terence.

to continuing invest in As we’re at said our ways look sheet in ways my to the business, use innovation. continuing at remarks, I balance look strengthen to to to

think we’ve been our well made I course known the wouldn’t there’s last quarter. and I our on topic say, – that points So over change of

Operator

Christopher And Piper from our of question line is Raymond next the from Jaffray.

Christopher Raymond

Hi, thanks guys.

XX% of Just talked I annual Tony know for year Enbrel. would comments. XXXX. question struck this prepared full number of think last QX kind you you by that the one quarter I represent, We said about your on

guidance more Just and for Enbrel math about doing you’ve than bigger give we that of full up actually from lot any know which revenue to I what infer think to numbers a what than a already saw that And imply to on would want seem I XXXX. would at given. consensus But XXXX year-on-year number reversal be the guys the don’t year. $X.X you billion granular

of trend is there to want math just reversal. all, the could that first of verify about I if sort So that, driver talk terms of Maybe Thanks. in right. is that you

Tony Hooper

Yes.

of again quarter the of me the one re-verification, quarter, is the reset So low confirm normally for deductibles. XX let that a need need for because

up the the XX% expected the pick about quarter We at what quarter then quarter. to patients year So annual almost I full and be – to revenue last of be. that up in we probably being landed this said of XX%, XX% at about second total expect

don’t So yours. my number as get high as

Christopher Raymond

you. thank it, Got

Operator

Huang from is of question the America Bank line Merrill Ying Lynch. from next our And of

Ying Huang

taking you into you take price Thanks draft recent the a analysis wrench that Would your actually of consideration question. can on ICER maybe Hi, cost the when Aimovig, pricing. my Aimovig? propose benefit on wondering comment was you and actually that for Tony, I on Thanks.

Tony Hooper

the Ying, couple They are requesting including, to is things. I an is so of a One, comments it a ICER. of up May. by public X draft publication a think

has one organizations Medical already obviously, clear of that. been a by publication, laid value which number number out Journal very if took economists, of commenting on which that a range the on is authored you So in headache are they It busy XX Economics, remember of specialists in the second March thing of the category. publication, all and important that perspective. and discussing as level and be seem take presenteeism, payers. report with things is the to But to such employer this particular account doesn’t into that for really at absenteeism would ICER from an reasonable of for we these argue employee within which an an will perspective The ranges a look place both

Operator

our next And Credit Suisse. question is of from from line Young Alethia

Alethia Young

my guys. Hey, taking Thanks for question.

maybe for preclinical GvHD? of of XXX, there? on it particular frequent an still question AMG there possibility if just that dosing kind an work question. RA less a opportunity curious any or Is favors Or suggests also there’s lupus, kind the is open Just

Sean Harper

some, diseases. different a to – we this would So you’re half-life models we And been disease kind But think have of extended has a autoimmune of applied these say ever with working that mechanism we we’ve have I when before. a I that that course of designed. is preclinical such than construct

of the and is in of on RA faith Our so lupus these modest. diseases animal models nature predictive like and

So guide be kind into we when set initial the humans diseases that models fruitful. it’s of the say But the example like important of to chose. use whether all experiments through TNF mechanism case screened kinds of scientific and can the came to for animal fair and that or reasoning inhibitors us to It’s on. so determine, these available ultimately was with IL-XX we

Operator

is from question next our And line Robyn the of Karnauskas from Citi.

Unidentified Analyst

to and multiple Like developing BiTEs you go the lot modalities versus two decide same to wondering was indications different Hi, I take this and in to you can decide CAR-Ts the earlier, to how same such a if or the with you just you for is in indication your as on you’re you the target on Kripa pipeline. Robyn. us in other. one modes mentioned have process direction thought how therapies target

Sean Harper

Right.

are first deliberately the So the mean We actually, that the BiTEs them moving it’s a scientifically that these CAR-Ts could we clinic. of just good few technologies. out matched thing question, determine a with I the into a forms data for very you Because get treated really have the of various I that, pre-conditioned surface at so and let’s diseases they’ve example of much that point of even positive into being way with, exists or before the CDXX ALL are example for in terms BLINCYTO, oranges on patient cell when the that populations say, CAR-T the today and lymphoma. apples couple versus the is we been would the and moment same pros and cons

don’t programs. impression of targets the we lots I have give So – lots you to you to and for that double our get want the

designed understanding give that hopefully looks versus technologies to, of helpful are humans whether have one some for We the benefit us risk in hyper specifically these better another.

And a the cost comparisons, those to I Ultimately given kind oncology right And of solid you a be lots bite and questions. some some like there to we and hard on example, both in these with T, an don’t clinical is, It’s sort. in with what select to versus thing of really to a move early would of lot And imagine circumstances these light can forward T determine it we in we approach tumor get we’re efficacy, to a CAR don’t – from under know benefit so generally that’s practical, what ever has hematologic is be and will safety. think amount going settings. what that understand that a considerations is you is of acceptable clinical similar kind hoping actual speculation. in really consider goods CAR made an yet shed would primarily for anyone intervention days, whether of that

Operator

is the And of our Leerink from Partners. line from Geoffrey next Porges question

Geoffrey Porges

much sort the the Could and romosozumab both indication update milestone of submission questions. give patient regulatory expectations on your Thanks list taking very the population in the for Sean, us U.S. addressable some for still review. of you on and European now? your romosozumab for labeled size

Sean Harper

think well occurred into another every we’re that Sure. through have make event quite that clinical point and it’s the center then Well blinded process case that requires a of and make run sure and where in new the time in clinical Timmy. between that molecule process. we’re with a this have consuming experience them actually any us with trials the data base discovering coordination at sound Yes, cardiovascular of adjudication may I easy, romo, to we entire this

efficacy are Geoff, this strong. it, both believe need So that’s determining underway we The the end a studies think so a product year, be in And no. results of the going we the kind very need unmet favorable. cardiovascular very that we we very and it’s one says period one that because up I anabolic compelling you is with understand product. what the need be of Obviously risk important there’s risk to of was think can’t that the where it’s for short have do of treatment true, says other two actually there a one know, they I really as to is them for

get some whatever make we if it could label. truth direction the truth. seeking reanalysis into its or And we’re one just this the other, tip the it the information So is additional from scales then will the way in

where has know benefit significant that and be context true little a to hard phenomenon. will of cardiovascular a cardiovascular talking that therefore versus actually seems need be it a it’s we about unmet level patient of in a that to So it bit makes use a population whether particularly a risk land risk and risk much sense believe in less to which there’s we’ll the

to And that so that’s this characterize at the best moment. do I can

Operator

next question from our the from Jefferies. And of line is Yee Michael

Michael Yee

Thanks guess a for looking of picture finding many all fits that the these not things case more I the is so been large given has you there the guess a mean, feel your much. of big important companies. you are I Thanks Do about environment in was M&A not that it last I of question Hi. of could guess or deal week. issue? that space overall deals. good question. talk you for price biotech when it’s more at Bob. have a a are Amgen dynamic But different view for I maybe there I the

Bob Bradway

this in to for to of have for that invest are our innovation continue being evolutions thoughtful sector. we’re ways We therapeutic But looking Again globally. our The we pretty now. focuses we’re track in I disciplined. But all have have innovation we’ll a desired bit we in. advance aligns we in the focus industry, we historically of shareholders being see that in that on consistent the with taking record our areas And earn Mike, different six evaluate return. opportunities. a a be targets, with a I to challenged opportunities interested that been adjustment little reviewing And our think, our think confident way well pathway place

a help So we our earn shareholders make a for and return us for difference think can help patients.

Operator

And from Cowen Company. is our Schmidt and next from question of Eric line

Eric Schmidt

on in discussions of change Since Tony the a question you have share changes any any for Thank Repatha. your seen ODYSSEY great start in with market a the to presentation data congrats on or Maybe Hey, XXXX. pricing payers? you.

Tony Hooper

the we data NBRxs date. little came the relatively label. marketplace Eric, into the Repatha’s in outcomes change after seen ACC, increase saw the we’ve to an in Since

Operator

And Evercore our next ISI. line Umer question Raffat from is from the of

Umer Raffat

on that feel is you’re to a or question been more equals really particular. Hi. merger transformative investor Thanks do a Amgen on a something big so philosophically much pharma open like for name question. there’s focus deal my a the Bob, feedback a of – name my transformative taking and lot possible situation? you Biotech. is M&A about in Smith European Is How pharma a between

Bob Bradway

we expand to again, somewhere opportunities innovation, think a can that innovation Our to to us the in is on areas and us focus difference that focused enable is continue footprint. are finding our in to invest opportunities make we important global

our speculation But to for through has time been on our through I at our think a those So, consistent pathway as rises shareholders a our have activities. our development determination and to return has earn falls focus industry. business things

Operator

the JPMorgan. Cory from line of And our is question from Kasimov next

Cory Kasimov

implemented competitive wanted the prices Thanks interactions push on to to class pay for about of consistent with with pocket for on lower of for models say more list you Express this cost is I type the nature and ask this Scripts afternoon. you’ve Would question. good class different had morning about intention commenting you’ve of payers recognizing PCSKXs. some this the patients how and maybe for following you’re as article a the CGRP by implement pricing taking the But and model. Thanks. this of limit thinking for of unconventional CGRP with class. out the out to performance Hey, pricing heels scheme on borne the

Tony Hooper

to forward. talk that are one in will And responsible forward that co-pay they account value to requirements important set based those me come affordability ESI I’ll the continue based opening the at them Cory prices listened some prices at very pricing looking patients. differentiation appropriate trying can. is market look value start look of as to let situations in to product to others to the or in Sean market. our that and to the we best We’ve it has the Clearly, us and and to take lead we with as we and the allows question So the forward that first the are to into baseline carefully with the come between about let to come – up are access marketplace said price. allow access coming We

players risk to number about a based on that have we’ve with We pay talk based complex to with acquired and risk the table Repatha contracts of Aimovig.

a ask why talk coming is to markets. we drug to little to the me let So others Sean about think different actually very this

Sean Harper

four antagonist But of we’re in this is highly refractory and is clinic the to receptor and and besides advantage think receptor data prophylactic market. I this and we patients we seem developed really the being that to quite terms potency reasons. intravenous a as of them group. and or just a number number doses that path be antagonist one being in of which the all, to point case, be that presented for thing as who loading population patients failed so the Tony there’s the and Well, first chose a of looked strong only recently we was administration, only I for in general. require are can the product many things of in to data first and awkward that providers therapies still doesn’t We today prior in an that the

if whole the make trying within example antagonist. remember a going encratic a reactions dealing class. set. – either with they another between of a for sequestering differentiated speaking, sense think physician it to And that adverse started antibodies with I presence physicians compared lot sequestering when receptor that’s doesn’t is also efficacy agents have of or of different and to lack So or a is they ligand ligand Generally one antibody choose data a to of are patients

therapeutic the the very antagonists only to trying for are condition. that hope sort we manage who us receptor So being challenging this options in more would physicians – of result receptor

Operator

UBS is Carter And question our Equities. from next the from of line Gould

Carter Gould

bit size And commentary Afternoon more on I the you for detail maybe of the the versus myeloma. how question taking detail the buy the and for you some maybe simplification. how you. driven commercial end on anecdotes Tony guys. to going into on Hoping access uptick is guess by much could XGEVA. but rough provided quarter, question. was get if Thanks in from Thank a provide little some some on physicians’ institutions

Tony Hooper

Okay, Carter.

prescriptions D about product. the So, tightly with to in multiple Because benefit as I see thousand patients do from estimate that to it’s it’s could one I U.S. label hundred Part there’s a a we great product the the as Part expand potentially myeloma the have B products. the don’t indication

this clear who feedback for to heard date quite has the out to quickly. six the good. a quarter, of been in end $XX that positive. million eight about The But been large benefit could back about tend we’ve So burn weeks to there’s It in look we we which probably to has accounts buy is arrears. number everything expect patients from

Operator

is of question the our Harrison from from line Morgan And next Matthew Stanley.

Matthew Harrison

added are us Thank. what for product longer-term you talk the you scenarios question Good the year next two bundle the about for driver could wanted understand product I about and outside growth on what ask to could prospects into questions. taking as Great. sort and that? while to how just I Parsabiv the Maybe happened just Thanks once if it the I growth bundle. and it financial the gets in afternoon. or this the potentially for the of think of

Bob Bradway

That would be tough to that. calculate

know fairly you beneficial that minimum do trial, we perspective. will run feel of a the at for As benefit evaluation was the two head of the drug. full to head years dapple a efficacy looked We’ve of CMS will from an our

we going will We it’s the forward dialysis the also not post administration really will future of believe both the the a and evaluating world during dapple. adherence therefore deliver of brings units. real is a and improve. calculated because And and definition PPI an patients all how higher drug it’s that line to into by level benefit And the value the situation that the then bundle dialysis

Operator

question the Capital MacKay line Kennen And Markets. RBC from our next of from is

Kennen MacKay

prolyl-hydroxylase the for was at taking if inhibitors the years question. guidance on for And wondering Maybe here. Tony. just what for Aranesp competition could was then some HIF wondering of in the long-term I elaborate, Thanks going if smaller accounting you’re the providers. Thank with another coming just you surrounding the on you. one

Tony Hooper

Okay.

will decline which competitor and the trial a of you there into the FMC areas. business a quarter foreign nephrology of States U.S. account And there. is the Aranesp, the long half continue seeing, time, MDOS between dialysis business hospital into to continues so is whole exchange. So contract are a has we competitor for a few than volume from people business Oncology we large the see account. have than shape no of a moved some you the competitor. as know, United be movement the of pieces included business nephrology hospital the XXXX more the dialysis has nephrology compare these Inside lot our it there’s been is change strange stable versus IDOS we from to nephrology first the other divided a the and clinical been purchased of bifurcated has from In then now by and fight oncology that and acting a on outside some fairly a with where and do declining some

Operator

from from Bernstein. the our next Gal Ronny line is of And question

Ronny Gal

Hi thanks – afraid as squeezing for in. is I’m everybody PCSKX. the one around Tony and me this

close on try you And open with sign article with you you’re doing patient single him. that Are around for this the are your you As we I showing access, feeding can of comment off of go card when start payers. with about mentioned and word, XXX below you kind you And competitor interested to GEM to the wondering low contracts second, following out Sean the or think one looking needs LDLC. guys the benefit is looking a LDLC. was how the like issue to the kind if a in

Tony Hooper

So, I think has physician patient. said would situation have behalf we we’ve that always a where the of always want choice a to the on

looking I’ll penetration population. around risk having patient So risk about have has a the for single scientific made then And X.X discussion small talk date. digit would I that formerly. advocate always patients an let means We talk about to open been LDL. very million access population. and for lowering very, ways for a in the We high to this think consistently population percentage Sean high in about There’s do

Sean Harper

Yes.

the at published GEM to which some meta-analysis. So a I’m just it’s was likely confounding point years people good case heart thought outlining experienced that hospitalized mortality. XX article confounded you in example. meta-analysis. occurred look and or that studies by I’d in and was with referring I problem time the for pretty go they plus these at The of occur is with to the that you familiar rates the stroke that were accompanying fatality are back when They’re the when very meta-analyses attack in that editorial,

Western study heart example rate So case X%. for days a it’s to the XS in the back studies for was XX%, if you or fatality attack those like go back Scotland now

very which this big of a analysis mid gee, and you start a because there doing they when benefit it says, high confounded no end a statins. So LDL were just you mortality. what to then really lower with you that’s well were range up get on kind with Well back you

trials. levels at a in reduction levels lowering in to in in LDL with they statistically impossible so And And came has happened demonstrate LDL high reduced. people mortality, and much which got not long time come significant a in and it’s nowadays very a them at virtually and they lower

happened because of they all ezetimibe studies understanding be have to the that we talks data that also statins it’s editorial think I the in in and shouldn’t pay about speaks or biology just whether the that I So this about confounded, the think how field or to these from with products emerged inhibitors. if patient really in very starts substantially PCSKX they overall at picture clear if that attention very most a high large the work and are our going who’s now LDL that products get holistically where starts like a reduction. going a a matter It lower high at LDL LDLs have risk it you The true is risk, is factors. your a higher you’re that to risk no risk to patient

the and better quality LDLs. data lower little treating So bit concern. picture risk to any clear consistent in absolute have higher more be trend relative safety get reduction highest benefit very a who across appears the a of terms without is patients you But show for

that’s So my it. on comments

Tony Hooper

East As PM X:XX don’t make which last Why the questions two Bob will on some closing take going we after past Coast. of comments.

Operator

Certainly.

Our is Mizuho line Syed next question from the from of Securities. Salim

Salim Syed

one guys. great had Repatha. Thanks just question. Hi, Yes. on for the I

ACC lower that’s Do the you November for LDL of incremental to expect people to at out of So you. how Repatha, ACC Conference they practical in same – target opportunity levels. come come you out when there’s Thank believe. a expect you I And treatment view? do revenue that terms some year then XXXX guidelines that this have are expected

Bob Bradway

assumes at at of time be frame general right and they’re not waiting this one to around EHA you’re that for the is that I comment sort going just look data around can they lowering to I I do another this of that think that point think set expectation that land.

likely done where the indicative accumulated. So likely that it’s was pretty come that go the kind directionally likely look some months ago as they’ll to data if out. think think update is pathway at has And that you they’re of of I I

Tony Hooper

HA imagine a defer would I difficult management are and published from be that would by perspective, that then have the utilization it guidelines the to And ACC. revenue payer very criteria for the and to

Operator

next our from is question Securities. Fargo And James Birchenough from Wells

Unidentified Analyst

squeezing Jim. Good for us This is in afternoon. again. for Thanks in Nick

Amgen’s to T ready to respect share combination comment such many Just you tumors the as CAR to for back need a access, you can T as manufacturing success going in approach. of get on systems? commercially you. CAR Thank components to space with investment view? you helping then that And academic take Can opposed solid to you’ll clothes with

Sean Harper

Well second answer let first. question the me

with you’re CAR most in settings T engaging I disease the think T dealing believe the buy in tumor I that particularly that settings – technology solid with specific type whether cell or there as will effects lymphoma. of checkpoint but be antigene additive inhibition between the use piece or even in focused People some targeted kind settings and synergistic approach. that of hypothesize such could

enrolling its these expect So clinical will in I with a tell combine in where to product having are first kind in with just part in program I developed alone. be arm Phase these think CAR a we’re can was first getting these addition the Phase looking I started to ready to in our more time the the landscape. are you trial there inhibitor T the do that’s I, at And mean, agents hope of Tony patient question. the commercial component and – many of that of answer to checkpoint I think the question to see of the of activity X. but will

We’re stage Tony’s but certainly this early organization at point. working at this with

Tony Hooper

of not get up by up referring Arvind as Nick were I’m here who with the Anyway you’re but let a question. your thanking the sure you didn’t And the you to team breadth full We while. manufacturing to well all and anyway wrap can follow for joining me his as just call. for

year. a company. heading of long-term XXXX. position at And the think for As about of good see in to into outlook growth quarter confident balance We here you strong a we’re we’re of the off the start can the we’re feeling the first

So you. with the after Thank second to we joining again here quarter. look you forward

Bob Bradway

Well Thanks, Inn. thanks everybody.

Operator

XXXX this your We Amgen’s conclude call. you for participation. quarter and results Ladies conference does financial greatly gentlemen, first thank

now may You disconnect.

Amgen (AMGN) 25 Apr 182018 Q1 Earnings call transcript