AMGN - Earnings call transcript Q3 2018

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Operator

My name is Ian and I will be your conference facilitator today for Amgen's Third 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

Excellent. Ian. Thanks everybody. afternoon, Good us joining today. for Thanks

lot We I'll to so ground my have comments a keep brief. cover, of

us Continued execution, our about launch themes progress, will third today review, for these and pipeline advancement I'm more, CEO. Gordon, David to of results. Meline hear review is joining quarter XXXX. provide elaborate joined CFO results to as the After Commercial our Global and themes quarter our for strategic and that our Bob Hooper, are mind I guidance and and third think updated Bradway, Also get our Head then today by Tony financial To Operations. newly you'll on Chairman appointed come some key Murdo Bob's from

of of will Head review Murdo's R&D, our performance, a provide product Reese update. pipeline David Following

will a and forward-looking some My use discussion presentation in slides link sent statements. to reminder today's to non-GAAP that We guide separately. our will be was will the statements we measures customary slides today use financial of those and

Our identify could results actual our factors differ filings materially. XX-K cause to that and subsequent

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

Robert Bradway

environment. QX, provide we're for Okay On you. today's performance call and share the making growth, long-term the to overview Arvind, healthcare of on our I'll in current in delivering thank strategy speak progress an our thoughts some

shareholders of high our by remain for innovating acknowledging start factors, by of the of patients driven that while a we're volatility unchanged. me and for and period midst variety Let and objectives the of in a intact fundamental political macro delivering benefit of

strength. ability in from position a navigate headwinds the future, to there Looking them be bound to to but confident we're our are of

growing is and that products strength innovative expected With cost large plainly We quarter once time efficient on strong needs having under You growth by structure. meeting ever volume flows, cash in drug important. our see that all this said we the price see We've healthy pressure, pressures some which industry. prices balance sheet, can of can that for more our evidence of again of patients today. deliver in numbers reflected

We With to Prolia continues our growth third long-term up recently you to had build growth. and in to globally and the taking launched open in where double-digit Aimovig steps important this patient potential products products quarter several and can We benefit of new continues to and untapped the unit like there products this differentiated have such access offer Prolia, osteoporosis. prospects. be Repatha believe attractive volume affordability Repatha, and strength the therapy. area large we're of improve see

announcements Repatha. to and lower week for get in are patients order patients to who significant that in need commitment our Repatha past reflect especially Medicare this ensure costs out-of-pocket help Our

and now their a be as new AMGEVITA, growth driver important very area. and for sure biosimilar unfold to an biosimilars to continues I'm We biosimilar off physicians migraine have from one prevention. story strong us waiting product that reflecting for internationally. Aimovig exists in as an can effective and new KANJINTI, not Our and very suffering fact a pent-up recent to believe launches they've in lost that People therapy shaping been most be well the with up it's in is for you years this successful Aimovig. to demand industry's Herceptin a we’re the to of well and reacted launching migraine is Humira Aimovig start

very Our innovative pipeline quickly. moving is

diseases. allocate where large capital to to we sizes innovative molecules As R&D we we you first-in-class believe effect have for with serious the aim know, potential and

increases Amgen's with clinic. seven value can we From introduced continued continue development in for and our talk a capital standpoint, to past we business a such few approach a to Dave dividend where programs create will the allocation disciplined the moment. these shareholders. we've take will into Reese more believe and share Over we've buyback months, about

to this political less remain new topical officials access U.S. for to The administration leads the our anytime policy treatments expect and very We embracing our it. need our to the soon. world benefits competition nation's advanced we end this to will drugs objective environment new and access costs without cures system Turning to the innovation. to committed improve reforms for society to obviously need a productivity, from what population working and therapies we is in with believe the ensures We innovation that that innovative health promote and and diseases. is don't and we and improve undermining U.S. elected not ecosystem. serious lower If healthcare this and discover more market-based remains

Let I strong mission. for note and a end their they're our staff by past for to me for finish to their efforts thanking or the dedication dedication their their know this dedication our and to hard working year on quarter. grateful I'm

to over turn me Let David

David Meline

Bob. encouraged enable of continue thanks transformation as growth we share transition. strong and are Okay, in our business to our that Overall quarter. earnings third per by investment double-digit the portfolio our pleased in we results both efforts earnings I'm navigate delivery our and

year-over-year. at unit X% quarter financial third as grew billion $X.X Page slide outpaced to results product $X.X brands. X year-over-year, declines Turning products grew quarter launched recently at billion new and volume strong the of our third deck. on in in mature Worldwide revenue X% in the sales the in growth Worldwide the our

biosimilar portfolio to Europe a at we've Novartis. continue years. payment milestone million Other year-over-year quarter in $XX increased to several competition We revenues market with Aimovig at volume our due related primarily products of for the received growth the experience $XXX XX% in reflecting million value to transition where partnership innovative our and a good experienced in

we we on as continue shareholder quarter As growth margin grow communicated in from XX% incremental year income earlier On prior billion value. and expect X investments to products at declined to maximize was this a to pipeline the Non-GAAP non-GAAP of full-year revenues offset cost partially year, drive Research year-over-year. other our product of for of operating higher and continue by X% XX.X% operating third cost by as charges XX.X% percent the related X% increased royalty impact of XX% at and basis product to driven QX expenses development XXXX. non-GAAP manufacturing Hurricane or versus million in increased X.X settlement and sales last portfolio $XXX QX expense a year-over-year reform of this lower points costs sales X% and sales XXXX. expenses decrease non-GAAP X.X were expenses products Maria by and investments a expenses quarter year-over-year. in versus third is as In to XX% year. estate increased lower rate liquidation The Other securities marketable million year-over-year as third unfavorable and the rebalancing due basis by XXXX. product cash of by income of SG&A on for tax of timing primarily quarter operating balance in Due the $XXX corporate increased quarter marketed basis a aggregate million the well support. quarter. driven a and net non-GAAP a a XX% versus a launches tax impacts received to U.S. QX point was this of of $XXX

share. share the was $X.X third income non-GAAP quarter $X.XX net per flat per earnings at and non-GAAP XX% for increased year-over-year billion year-over-year quarter to Third

XXXX versus to cash of third generated The of the next billion driven billion on Page quarter by to company and tax $X.X balance $X.X of X. free in in third Turning payments. the the cash XXXX timing flow sheet flow quarter

shares over significant million continue consistent billion over to year-over-year X.X We commitment time. opportunistically. in count shareholders at deployed to provide average $XXX to under share. deploy Reflecting to $X we we XX% cash have X.X average repurchase excess authorization of our our returns per remaining which QX continue share with Further we an deploy will current cash reduction billion in an

driven last million billion in buybacks This of of over months $XX free over was totaled flow dividend last form cash $XX.X of of period. share year. an $XX the primarily $X.XX the a over decrease cash return third increase $XX.X the quarter quarter in billion third XX% billion investments Cash our offset shareholders and to last share the of Lastly of from to by decrease XX dividends per generated partially increase and year. same by

carrying of and Our total at balance as XX, rate $XX.X debt weighted of gross maturity XXXX a September years. of interest X.X% average XX.X stands billion average

for to on XXXX for global populations. plans We volume and increasing presence investing Turning in continue track long-term in growth patient to the the business remain with our on spend out of our Page X. support our outlook next building large across pipeline

delivering solid performance. While business

confidence Our solid in the quarters our revised the our fourth in business conviction XXXX performance performance strong guidance the in is driven quarter continued of year and first strategy. over by three

of remainder $XX.X our no of guidance $XX.X revenue is of billion generic our for latest guidance billion $XX.X assumes Our previous $XX.X billion of versus sense to for revenue. competition The the high-end to range billion XXXX.

$XX.XX earnings non-GAAP previous we're share $XX revising per guidance versus outlook our $XX. guidance $XX.XX to of to Regarding share the per to

increase expense a As quarter for reminder, to over quarter XX% business. pattern operating reflecting the expect the typical to we QX total XX%

really as financial the grow the are affirming to now million track approximately on continue performance We’ll on year. this In update, business. of our that capital we remains investing I tax we are and concludes XX.X% we're provide prior to call This to turn guidance summary, Murdo. $XXX the our over We XXXX XX.X% call. non-GAAP expenditures of expect pleased January XXXX guidance

Murdo Gordon

people extremely have large patient experience that and will of available here benefit excited by been a Amgen special is has products and I focused. biosimilars rich my such a highly join early with talented unique tradition David. strong now highly impressed I’m culture Amgen at patients. commercially opportunity a science, along a with innovative Thanks the to pipeline and that of numbers been tremendous company has positive.

represent internationally. recall breast unmet held fractures results fragility fractures and some more $XX seasonality for a is cost Repeat injection competitively. a heart attack, and with with see our XXXX operations year. increasing you'll continue remain you growth need it's of volume to to U.S. this I'm we with treat driven the address XX% XX% can Prolia U.S. Osteoporotic rates from growth. Now quarter If quarter at large third and sales patients U.S. XX% pleased demand sales share we and XX. brand I to Prolia, volume by year-over-year on report sales find on which the excluding volume performance effect to international delivered turn beginning to driven gains the was deliver that growth delivered XX% QX sales in product with similar in XXXX increasing By large to expensive billion foreign despite especially developed do outstanding expected than slide strokes performance be very hospitalizations in the quarters priced XX% another in the on growth and biologics our are and starting cancer. this exchange novel burden the if over strong prior we the both true in Prolia to information in competition, very which to

Moving starting ex to our in which on KYPROLIS year U.S. by oncology product with our business. XX% driven primarily growth year grew

sales the to there trial QX not from a recall which due was previous you As benefit purchase repeat quarter a in in QX. to did clinical

overall Our KYPROLIS U.S. third throughout in patient a team the both survival executing total is we've emphasizing gradually benefit strategy seen new and in increasing. and patient of diligently quarter shares the

year-over-year expand R&D next-generation committed update. October In X, include we will from to into is commitment our label have to earlier option demonstrates myeloma to This Furthermore say to treat convenient to the multiple label from myeloma with more XGEVA and Dave addition providing his we XX% to that a approval Reese innovative about serve Amgen more generation evidence patients on received continued weekly volume and for dosing update as innovation year. grew this expanded multiple medicines KYPROLIS. in the primarily with once Amgen's to patients. FDA

feedback physicians grow continue We positive and to that in from and receive share to continue segment. institutions

XX% now year-over-year, to biosimilar by the a selling for share and continues of lower segment the of the a to to the reduction sales U.S. sales Onpro in unit in few majority quarters overall and decline Neulasta the small was lower in market. share we as demand represent decreased Turning segment face greater X% the price in we past decline due quarter. U.S. in We net Neulasta market third seen observed than a driven competition slight

to believe Onpro of experience better to drives and neutropenia appearance continue We leads and a patient rates which hospitalizations. therapy better febrile lower to

continue We’ll account supply our the quality we’ll competition sales. to and pressure confident and will establish and account serve G-CSF One by market year that For receives we several and when Neulasta is preparing the long-acting in Neulasta the biosimilar will biosimilar years, more experience by record well. end day compete segment and several for remain as we've anticipate approval been launches, in next which of a to dependable

NEUPOGEN, exited the U.S. XX% in holding segment we the the quarter For acting of third share short

pressure gain to biosimilars As time share over continued intensify. to continues expected and by pricing

and of year-over-year IMLYGIC Nplate, volume quarter, individually the up they combine Regarding million smaller XX% sales Vectibix, deliver in BLINCYTO, $XXX to XX% while growth. with

to is fundamental recent launch system, declined Switching price and ESA an a to This in was patients year-over-year formulation. positive our Overall volume underlying XX the and X% price to investment now accounting competitive. of Mini expect due brand Moving both increasingly portfolio, trends. AutoTouch that the the our innovative continues offset share with trends some to our After net lower SEAM-PsA study, Sales and fundamentals net Enbrel the rheumatology years year-over-year category with the becoming declined the delivery with favorable the on to recent dermatology improved selling commitment in adjustments. completion segments and with in Enbrel. selling in of market consistent we by X% continue. EPOGEN

With the business of a the launch provides expect X% which primarily on size independent Aranesp a a declined in by biosimilar acting organizations. product by mid-sized our and breakout a Slide of decline in within. XX, segment of driven provides year-over-year competition selling ESA the would from long and we dialysis that clarity in U.S. potential performance price. each further increased the

in Assuming compete. launched we're all prepared approved to deport biosimilar that the segments, in

clinical gradually continues patients now several an we healthcare DaVita drive hands level benefits provider mid-sized Parsabiv in Parsabiv Turning including continue which putting independent to adoption. the providers. uptake see dialysis to to adherence. to strong has at deliver the control calcimimetics. the markets of where patient also in could by Fresenius are and and of U.S. increasing launched improved

launch at from Sensipar the gears may generic for Herceptin, portfolio, remains product Turning of that biosimilar ongoing our to European Shifting countries. the have month a Sensipar, The uncertain biosimilar Parsabiv. AMGEVITA, sales this KANJINTI, market Amgen's still outlook given litigation. first competition to we declined Humira, launched our are with version a Europe. XX% possible and year-over-year risk. excited We're of It launched innovative pleased across we're in of commercial launched have number products to to biosimilar earlier enter

programs an to to business class Europe. development important in share grew a We XX% years be the expect and driver eight have biosimilar year-over-year U.S. and leading additional we Repatha we compete continue to growth PCSKX in by of this come. with as in in XX% for effectively the XX%

copay hurdles Regarding too them access in patients who to last made Repatha strong patient for from affordability decision who the could the of Repatha strides business, of an as we've the Medicare light their calculated at face is high improve to which Despite price improve XX% a patients out-of-pocket our launched cost to progress NDC we've U.S. D was represent copay for that expenses. market. $X,XXX of rate Repatha. new access patients, only significant only We've it's should In their option a important to reduce to is and therapy, compete. making XX%. especially viable made to Medicare list many for all lower available to as due good is also out-of-pocket of price. and abandonment we as This week made of Not lower the the patients this, Part high the necessary which benefit costs but list this substantially from

to important accessible expect patients. sales impact the we therapy see Repatha as update many plans and near price affordable as impact Although lower on term, may volume for growth this more positive a more becomes

high-risk authorities not patients. Overall work to treating help to these avenues high-risk business, all to with to population and cardio patients Regarding we the the of The society priority to our optimize unacceptable large a is around cost for share vascular to investigate and continue majority improve of ex-U.S. patients continue maintain to continue access. our we country remains access appropriate world.

been more which to physician Aimovig, launches Now in industry aim and within seen moving the my area this to broadly. of strongest in this from of even experience innovative and that launch communities therapeutic We've one by the remarkable therapy. the patient this response represents energized both due further I've

over XX,XXX healthcare to resulting requests early to patients sizeable patients market. pent up that to up from the of Aimovig of starting gaining in The working third services we in assist over prescribe professionals since access Aimovig set launch. the product have resolve week As the demand October, been XXX,XXX the in

the gained product the U.S. we've approval As expect in feel and patient products Aimovig's confident additional addressed initial bolus have demand of we we and normalize our coming prescription to over two compete moderate the activity with Since differentiated our profile. launch, ability to in weeks.

treatment receptor first an advantage. only in monthly first our autoinjector. in delivered easy migraine does that Aimovig a the SureClick addition and Aimovig use the is CGRP. have once specifically mover We to preventive And blocks simple to is with

still nature through However, QX. given current low whom of extended patients above And awareness at part advertising of the XX%. first television campaign for our just we've direct-to-consumer be appropriate aided Aimovig would among debilitating education in patient remains the migraine,

Amgen. to performance Aimovig the by rates lives As lead their priced and favorable have copay rapidly of opportunity I'm and quarter offers with as a these volume in transition to our summary, success excited to the loved I'm lasting access, a growth. to utilization driven reflecting exemplified previously of In the serve patients a coverage. result consistency manageable is normal initial about of lives. in continue have with XXXX, large. the to society we front execution and a ones Migraine the in at more portfolio our new continues patients under for levels moved third patients to of we that established pleased opportunities a Aimovig approval significant levels exit with on and impact management debilitating been condition Due access. are having commercial that to

for one working Amgen tenure once they of of I'd focused his me the has to successful his after time in many turn Tony And run Commercial, Reese. Hooper, by to who that, do thanking for Amgen, as very thank over our hard close and Tony and for employees, with it transitioning that's commercial each me of let most well in a I'm every day. organization. patient and Dave support. guidance grateful leadership here handing employees our patients of Head all is again like been I'll extremely very and over generous to the a at So role

David Reese

Thanks Murdo.

the FLTX As XXX Bob began programs. poor generation cut a ultimately overall the of we begin new cure an these standards using Starting a survival, Six within a clinical generation FLTX, by targets our demonstrated cells. associated will area with BiTE, combination drugs. human BiTE strategy extended the as is T-cell of Also R&D proteasome receptor. One cells half-life a combinations AMG inhibitor disease about goal the care Kyprolis, superior the which prognosis this achieve all phase exciting to there. to look in mutations of year. disease different stage and FLTX of occurs XXX element mentioned, oncology mutant core our over the each AML data XX,XXX we CDXX in Likewise deep foundational to I contrast life transform sequential almost with is type of patients. patients and year are is opportunity on both targets the earlier of containing receptor eradicate are is first bispecific in to entering in of in early expression AMG using myeloma, against BiTEs inhibitors by standard by AML seven multiple targets including the AML gold effective extremely is molecule in our from our Activating my and against and small AML, of is are therapeutic extended our the potent in or study year. enrolling which engager AMG AMG functional X platform. the regimens U.S. that with forms directed forward responses Having Kyprolis XXX remarks CDXX wild our Phase type efficacy later XXX, and this a oncology. mutant highly half durable through in including In in FLTX, therapy to present both of to wild first we expressed

the convenient mentioned, Murdo help weekly potent provides regimen patients. this Kyprolis which more dosing will approval As regimen the highly more a serve we of therapy of hope

a potential myeloma In of addition entered Kyprolis, two therapeutics just portfolio the that we to have clinic. including high

our are First, oral our CDXX lymphoma non we developed collaboration XXX, and in Hodgkin's myeloma AML. as Mcl-X as with XXX the bispecific AMG inhibitor in AMG second, antibody multiple pursuing Xencor. which well And

first-in-class recall that small is You progressing also MCLX IV administered our Phase inhibitor X. will molecule through

extended forward to Finally, to we BiTE looking are BCMA first half XXX program where about we X the molecule at medical fourth our BiTE AMG much initial XXX a our life continues present generation in our from data and to very Phase the the clinical BCMA are quarter. excited enroll very in opportunity AMG conference

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area version BiTE a medical unmet high patient today program an programs BLINCYTO. our with which to and therapies time gives will explore T XXX, lung our our against first-in-class these programs directed evaluate us DLLX the allow half-life potential cancer, CD optimal This are Another a XXX is T at for need. This oncology ability in small XX number CAR Amgen first-in-class significant parallel, us in cell of AMG the lung clinical AMG pipeline. And dosing small with to our finally, of unique advancing extended unique DLLX is of first we BiTE now cell utilization the through a cancer. CAR of

programs get more will in many San programs quickly I therapies I to on these then note and may rapidly PM, and that December as pivotal proof-of-concept upcoming establish We hosting patients Investor there of are we move hope to Diego possible. that meeting on Relations we development the into in as so person. X:XX at these see you would share innovative these night, phase, event where have designed to we X, the at ASH exciting an Monday

with Turning XXX, XXXX. our by prevention areas. In Novartis, for a cardiovascular to continue we presentation began in year-end from medical receptor XXX, AMG Phase antibody collaboration our In remained a Phase migraine results enrolling X we elevated our study therapy, for AMG reflecting strongly LDL Phase expect to risk at briskly study a interfering neuroscience medicine, PACX in disease, with independent to patients largely other small for a approach. X conference failure has of enroll therapeutic outcome of patients, In our cholesterol, novel Lp(a) Lp(a) unmodifiable. enthusiasm continues it RNA associated is of increased cardiovascular collaboration the mecarbil the omecamtiv X with for heart this Cytokinetics,

severe asthma pathways recently the class program continues for We TSLP We the in for heart clinic the failure. novel phenotype. modulator near inflammatory AMG an look for of XXX, with the X breakthrough severe eosinophilic also significant our of an Tezepelumab uncontrolled granting by our activator progress targets advancing multiple inflammation forward future. AMG well. to filed troponin Tezepelumab FDA to by The In first-in with asthma collaboration in need a without novel an patients was treatment recognized into AstraZeneca, unmet XXX with to address IND our for enrolling upstream Phase study therapy designation potential

to continue programs biosimilar our Finally, advance.

quarter first are year. preparing our Remicade XXX, submissions and which regulatory the to of our biosimilar EU by next occur for we We ABP expect US

our achieved lives I'll of of are can hard of and alignment make start-up advance difference worked real colleagues medicines pivotal ABP Soliris the study also patients. design close so there to update on in the now for XXX, and have thanking here the in study. Bob? at biosimilar Phase my global a who end Amgen that my all by We X

Robert Bradway

Thank David. Okay. you,

Tony As be a will Hooper anything Q&A, for Amgen earnings This is part is Tony at so the who start ritual, earlier, his the there of to and with life been we be want XX years, now us last on his beyond is Arvind call has past noted with us. the quarterly will year-end. to say you before listeners? call This he

Tony Hooper

much folks. very you thank Bob, afternoon, Well, Good indeed.

of we're I'm our him experience in week now so commercial of its does He team why with those bring to excited efforts, fresh For twice to help so, him who successful in. listened of mission to or and executive a about on you many with the have Murdo last of set the also the eyes He Amgen. joining understand you decades bring in journey. lead Amgen areas of the Amgen next participates therapeutic of will stage that set our sure

legacy rapidly had the serving a staff call, I'd the that opportunity We have also pleasure succession beyond ever for nothing planning for got to falls years those passion revenue pleasure and and then delivers Amgen As Bob work growing like is transition, like They tracks, most can patients at the years. I'd that so with. is group my seven of ensure goals to the and a over that Amgen. an that on with the our company defending the Murdo I one and well brands. focus considered I've them. all tough process. work to take are the that this to thank words. They also carefully competitive today in and second of investors a hallmarks the on interactions to thank unrelentingly are of involved analysts I run call the the Murdo over mentioned executing also groups one quarter to had orderly planned for sets

very Thank and have appreciated. Your been you always guidances challenges your much.

Robert Bradway

Thanks. it don't of And that we remind our if With the turn Q&A. for over use to that, why callers the just you Ian, you. thank we Okay, purpose. process that

Operator

is question Harrison Our of [Operator line the Morgan from Instructions] first Stanley. Matthew from

Matthew Harrison

appreciate I for could. question a if I question. it. the about taking ask much wanted biosimilars, very Thanks I to

market? competitive. I'm in in could the dynamics that the just And a TNF how So could view detail recent you biosimilars in outlook it's fairly the Obviously, But bit seen you just launches, little if comment for little comment on and view you outlook Thanks. you how you how Europe? launches. some Humira competitive wondering view bit more maybe the we've a about

Robert Bradway

Early we so days still. far. But we see what like,

our but we early As said good. we've so KANJINTI in we're you launched products know, as AMGEVITA, far days, so and two

we look internationally well. forward the So have portfolio well? launching advancing as other through eight to those Murdo, clinic, molecules and incremental of thoughts we from you, any

Murdo Gordon

strength market Yes, having a in well period with of time, being with processes obviously quite in we've we've tender Germany. through series experience, in done more longer got a particular the for KANJINTI,

but I AMGEVITA, very but to think little too competitive it's and competitive obviously be will seen a ground process, with is we the a activity strong. it tell early the team have on

about for thing the to portfolio is, able Amgen of to in the authorities biosimilars oncology is, and them dependable the to The portfolio embedding and we'll be our particularly think the our world. alongside Amgen relates the we providers quality reimbursement be innovative will some benefits and as explain to supply with around of biosimilars it other portfolio

Operator

And our next question line Geoffrey Barclays. Meacham of is from from the

Geoffrey Meacham

question foundational how But broader Murdo grow get and preliminary OUS much on seat. for I you. a know more you Amgen of wanted asset to Murdo, asking it's versus Bob. that of priority strategies business, is base perhaps revenue to the A the early thoughts in it's days now I to your much component do just broadly. can Thank have this? a OUS be I'm because growing smaller peers, but

Robert Bradway

parts We Geoff, will off. the in two answer kick take I'll

it's the our recognition products, delivering be reflects our and value early by strategy you but an And of double-digit our know, of in of the important demonstrate in I international results. in to to to think other some international markets, Murdo? able growth for As markets days new Asia so we've and long-term of I shareholders. do far, now us we're and we the that particular emerging the for quarter-after-quarter expect still our growth think of been that volume part encouraged again,

Murdo Gordon

echo would and the I China. Bob, Yes, would with add happened events good just same for a remarks, of Repatha I few in have us approval that

a to with our in have We and partnership we XXXX. that Astellas, expanding great beyond Japan in forward look partners

innovations will and Australia of Europe, business R&D great and and Canada, businesses from my was as Amgen's markets. focus, world continue businesses rest it the our ex-U.S. have it We is the available to the grow pipeline emerging Tony's it be focus to make across those in in

footprint size to to outside from the for us U.S. XXX. opportunity a an a sized So of company XX gone That's affords countries we've and our good expand

Operator

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

Ying Huang

recent a Aimovig. color, give on Amgen then secondly Trump us on do proposal administration Part question Medicare impact? mitigate on given B. you And little Bob have a the maybe reform the more from So the can What can negative I potentially to

Thank Given so competing far, other therapies you apparent clinical data do contract for against negotiation? differentiation position XXXX of the two how market to you. lack the Aimovig

Robert Bradway

question, the this proposal, With take your with I'll two parts. question could the, with start point, proposal. respond I'd environment we'll about the and Again, it to One respect kick your question on Aimovig. political is to to your to at that Okay. which about it is think Murdo start in then I just this a

is no be to and We access the take the eliminate to will objective and there of innovative includes point of are Murdo products? shape. to the will think in just comment bit in need in our system plenty and trying competitiveness those starting and for continue try proposal the and can you to that done time again, We interest who this the underscores address But a with shape at unnecessary to there ideas and our eventual congress some question, administration want advance the to them, Part quite is differentiation in continue therapies we outcome to the commitment our B. proposal improve to friction our would be that make sure with that of cost will between that, expect it drugs see things and can but innovative there in and Washington. system, it to a work discussions patients help the be the in get

Murdo Gordon

Well, yes.

fantastic As prepared Aimovig in has success. I been the my remarks, of launch said a

the indeed and dose the payer so We my antagonist there receptor hearing mentioned have on very been for good have fact patient feedback in also to only far. good loading We're launch. is no as our quite good - And CGRP. Aimovig approvals is provider seen payer prepared to I response remarks, really and that also that

approve approval to strong that's a payer a signal product to symptomatic do them, for and really, category a pay rate in new indeed that agents. XX% want about really these payers us to So want for

at having a one through this secured that strong we've rest, with initiated but puts position believe open. really secure that with differentiated both tried been a really category with the patients to continue PBM able working a product and over program You've having payers coverage far, for XX,XXX to-date sure work the having least is to being to large us strong this physicians seen reimbursement to make ESI insurer. through reimbursement to we're that XXX,XXX their I bridge in to product and from mover first in and so And patients initiation having

Operator

is question next Flynn Goldman our line of Sachs. from Terence from And

Terence Flynn

I for give we the models walk high XXXX we And both as dynamics Dave, our margins you and us look and in we top guidance Thank line XXXX, year? want can through but expectations maybe about wondering, recognize this the just that similar you think to for January, you. we puts should don't saw to takes here. level until should a at expect then what something pricing if just

David Meline

we've next offer years. is in contributors said, in going pipeline that got the but to to where efficient year, I the work and opportunities a exciting we've very get fund continuing are last program the as put So we'll several running of the a what ourselves continuous company, that out And over January, terms a of improve competitiveness we I we're in to by help productivity, us start I guidance place given to developing. now would right improvement in are challenge performance done very will we've which our guess manner to that incremental pointing formal

was fair business, about that side, we we particular Most of and do question we're an if Aimovig, an at around The I ongoing committed new are revenue second build that recently recently look to is is investment our to mention I'd thing products. which most continuing also of finally, continue the increase support out, in investment to is Neulasta international, as the the basis. And now that encouraged And of double-digit to legacy amount side course, be to of and product portfolio. Sensipar. growth seeing competition ongoing going a relates uncertainty what in new the on have in it we're of the the eventually as the the we path timing, our by then

information nice we'll But open at run not to business we'll opportunities and share seek in of the terms incremental overall, continue an margins with see and the we'll making while established profitability by a we'll that you we rate that's we've be time. missing think optimize guidance we're January any question able to that and on to those invest. our So sure to have

Robert Bradway

pricing Terence, be about it's us premature to comments think pricing. any on offering I XXXX for

I think at for what the of it we'll we're environment and all just So leave now is aware that for pricing globally now.

Operator

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

Chris Raymond

Maybe biosimilar question another I if might.

to this for pretty biosimilar I while. the highlight you program, a guys from then eculizumab don't the over biosimilar had on effort that think go much just you in I think the still having Just prominently EU about a But think I think despite trial. really I your now, this that's regulators start year ahead program And website. on talk

and question program the in hear is maybe this guess we way? you what can I we us tell maybe will when when more about Thanks. do, So

Robert Bradway

we respond Chris? ask don't question, Dave to your Why

David Reese

expertise. well that a patient disease so focused number enrollment positioned a where we're program, that X Yes. to This the of feel competitive Then there targets Phase where of course global alignment the also tend in study we are, study. for be are as of program. and I mentioned, and achieved of start-up they Pharmacodynamic we trial limited execute on we finished that that activities we're we and centers X in of There's this Pharmacokinetic in design patients, terms have based Phase to

Operator

our And Company. Phil Cowen from & Nadeau question next of line is from

Phil Nadeau

months I us of the and wanted have could on Can of Thanks. couple information Sensipar timelines when incremental finish? the remind ask to litigation more litigation you mentioned year. there it in you particular early you in ago, of that next

Robert Bradway

the The the normal visible for year, you And part for of with the of we have be run under legal Sensipar. but respect you you'd if reiterate process appeals obviously way a timeline process. be about when litigation like this said will the balance now is and can don't to guidance what David, there, just will

David Meline

Yes.

year-end at what would those at yes, monitor continuing obviously a scenarios. XXXX where and top range have the the we the So if would and a the indicated to be would guidance, continue Sensipar through generic we launch end that risk range present other within with time, there at is we without it least. updated we're were which include But, so we've in at includes, competition

Operator

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

Robyn Karnauskas

guess may can And in touched drug step the a to these revenue around capacity forcing and at I right the unlimited you a be biosimilar are are understand question use in asset regarding another - us the it. plans there what you're grand people others? go Neulasta now, cheaper taking X. that around would given for here the you've situation step drug just of in what was out advantage, seeing new field January percentage over Thanks. a for already Neulasta help in us understand since then help initially of specifically edits if Can effect you August Medicare and are full

Robert Bradway

question. we're having bit a little times hearing you Robyn, difficulty at your during

we know want response I'll to any I to So in specific thoughts. don't to you give Murdo question, that advise but offer percentages your

Murdo Gordon

how pleased been Part and Medicare, of the we far Yes, in that But But Medicare Medicare Medicare, if properly. step biosimilars, to heard I specific And the I light think far, think biosimilars. on with say in plans are Medicare Medicare are so of what advantages B Advantage B. or to XXXX. related expect we've clearly aware would to the particularly case that on we Part edits there impact I was be would are on that side certain that so question - of of would in moderate step has how been Part been the D edits XXXB Part we B however, managed the be the have side Neulasta

it. see where it's we'll propagation think to I see but pin hard that, specifically we'll down Beyond more

Operator

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

Michael Yee

expect speak you Wanted XXX an focus lot out. be yourself data bispecifics you have how Thanks. guess, R&D on question with the AMG overall? expect to CAR Ts competitive, with. that how to and maybe with BCMAs early could or be bispecifics obviously you've you to maybe to obviously start about highlighting you platform, more ask you a bispecific was to off a to And some positioned are I overall and expected just if BiTE BCMA versus reported

David Reese

as academic these first CAR Number I all center find they Ts can a start saying, one, the mutually goal these question. thanks pleased to we've a We is center are do off of an seen data oncologist quite of programs. so the off don't by think BCMA would deliver therapies at be will at medicine far for directed with We've shelf been specialized in home. BiTEs all opposed think potential expect for the the or Yes, advantages. deliver and shelf CAR to exclusive. these have necessarily programs high level our in BiTE We in some a to the our that average an community that whether an Ts. therapies,

to with be goods, which deliver as in using believe in these ability to responses. the course sequentially, a that by tumor a the or the multiple I BiTE then here competitive think to of in deep them also to cell cost We very of at really shots, I targets, add and after multiple affords durable longer able we term, will are platform, be expect And goal either to us produce important. is going combination it mentioned take and our finally

Operator

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

Geoffrey Porges

for Question you Bob.

are portfolio, pressures of the in at your parts opportunities. but different some of obviously results, commentary the a all in there Looking of lot also

what commented past, price that company you've the the running more expectation that's sort business you your - And perspective with sort from assets the the are of are you whether is Amgen the question by the current obviously have Could and us or with to from the of of then perspective on a the opportunities stability secondly, attractive in expectation things the growth of constrained First assets development been of expect and start becoming available cadence would portfolio? changing. both and of to available move? industry and sense give you

Robert Bradway

Geoff, try to position long-term the our is deliver growth for to shareholders. to Company orientation our

with can of focus generate that of growth innovation long-term a the on demonstrate globally. portfolio benefit ability to it starts ability our and to the value the then that delivering that innovation, the So capture is

think kind that's well that to same Company look patent focused our will that we for strong And of the sector So to continue position well. time, opportunities with we've shareholders. have we're our stage some of right, you're earlier peers on. addition, in think to I And industry what dealing to of individual through as volatile you manage opportunities. position positioned own we those a we value we're in the the deal with is that the expirations, but be, suspect to as adds advance headwinds for been do at development some moment. started we through to the business as our we in And point out, down think good our companies At capitalized have in we the where innovation will and can and come valuations to have well,

So And that. to as it continue we're paying expect. close attention you do to we would will

I or adjusting activity so, like think that cadence the an I Geoff, to are respect in not, observe we'll the whether with As in sector. on fair to see it's prices wouldn't to increase comment but

Operator

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

Ronny Gal

of two of Amgen Bob, Pharma. and first Head then a the you, as for questions as CEO

First kind Amgen years, of just say of you X, the - your and revenue about biosimilar of percentage pick your a what achieve biosimilar should biosimilar business, business, conceptually, what horizon think X, choosing. XX if

or their Just principal? benchmark support a countries proposal the about determine will where prices helping can other of second in proposal. the international US you about And data prices as is thinking or get you're to set basic the question a feel to use shape how this. any guess US pharma for talked accept administration I

Robert Bradway

Ronny, different two questions very there. So,

of that advancing aggregate, revenue important be products, we in market as for to of think respect an can plus opportunity. this billion you First, biosimilars, said growth with address know, they us. driver we We've $XX XX are

dollar the budget being past a in far, for and that difficult about operating we've in of but talked We're pleased it's We've the for so case. that on have unit it some be a potentially with would competitors, business this we We area. been that proving expected multi-billion this noted on time us. our

that XX And innovative advance growth be the change our this been think can that's and driver similar a we we state molecules. to far continue a our not But and have going hand in of products by we portfolio to So, for we to be like will obvious, on our us. as driven so biosimilars. we

particularly enables this an to to well, And to get is said, to think And and what's We people we maintained other that than if having can And to critical. and countries. this ecosystem question remain are the contribute to in innovation access I've or of we aging on what led that access country they think is that country, benefiting as the more benefited can has availability making have with from the innovation, about required innovative our in still than new is So of think respect and innovation environment and citizens on you and it patients more call, going system access earlier other the rapidly are our in in the more look not this innovative that United States obviously swiftly. focused we across said we're it that both citizens to And comprehensively society your business. the to seeing in countries, more it. overwhelmingly from diseases, innovation, pricing growth, quickly business that medicines less. balance think I as is the

So our well. and think can you that's on been focused as we're trade I that's what what see focused on, has association

Operator

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

Umer Raffat

the specific not the n center on total design we data, versus investigator showed trial that the CRs. what's your more into understand First BCMA, And X just where but those the at the the is on my question ASH. total on, specifically so n in heading

you want you to for have I on class on better. is grow ask and then Just secondly, X wanted to normalize. to ask will slide CGRP. My but sense more the moderate Murdo, continue that. don't to to X want expect so close mentioned it is, TRx and or do Just activity understand think to And TMB you the is the to are I getting we share? peaking question a you update, what Do that competitors

Robert Bradway

Okay, we'll just answer in two parts, Dave.

David Reese

let of so The me trial Yes, start first in-human with BCMA. the the design dose standard the escalation. is

year present a the which the the are of to cohorts, trial cohort. range to data leave investigators size, across by present all to expect So sizes who would details that quite doses. of we course I'll later of the run sample including sample it of in the across the

Murdo Gordon

of market. point is CGRP and that point And in availability the the we a anticipating patients pent-up I for where thanks was kind significant result think see our of trend of call. think we're Umer to saturating not technical different some questions me the of moderating asking on you this The Aimovig. But demand was market we were don't making current

slope change through, pent-up curve, will still demand bolus strong but launch made launches other the XX%. the doubled. other And the uptake just would patient current patients of that I of will I those other to you is that since there that and work our the large - some slight DTC services physician, be then a especially of compare our is hub quite it is So to draw patient very media At you attention when we've website and we And to patients be saw will traffic see categories. it and a recent sorry in spontaneous and in that coming digital here comment a the are our that will our in the part between other awareness unaided point, XX% a campaign curve. has launch of what seen your curve,

- chronic preventative And really helping with we're of we migraine migraine therapy sufferers surface Aimovig. scratching as such our think so the

early that see really a bolus was our of patients curve, working we'll comment of a continued we it just the having through demand uptake that think on So part growth.

Operator

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

Kennen MacKay

those to have then many Murdo. are another maybe was following have really The for prior could versus commercial patient Aimovig I XXX,XXX reimbursement? the on And free help to on numbers I drug hoping spectacular been XXX,XXX still of launch Slide us and prescriptions up of how to exponential question display with on your many how trajectory for commercial of you transitioned in understand I relating trajectory XX. or sort XXXk question only you. uptake that sort appears Thank purposes on uptake out suggest into sort that almost number? chart could chart moderation, there of Is October be XX reading

Murdo Gordon

is about my You the recent obviously launches. sound like question. And the medicine helpful this talking I interesting are is the about when sufferers. better to allowed indeed team Aimovig. payers and unmet We're do those few significantly launch Two, sufferers Thanks Kenny. here It that. of three, have high. for this a very I'm And consider to things need very chronic is really for One, chronic migraine there a for reimbursement than excited trajectory.

portion much question paid. indeed to that So how would of cart anticipate paid early is much we and a be how of your is our is significant will overtime launch free

feedback services have patient we strong our through both think really hub. anecdotally I and

other would continue specialist and physician categories. trajectory launch or feedback that exceeds We strong we the other be to will headache have from that benchmarks really expect one

paid, a we're closing ratio quickly. versus As of do, but the on for free the gap I hard it's quite will percentage really specific say to

are services our patients same, more is the not the and trajectory patient those on than that through if uptake retail hub going our not rapidly rising is to straight So product total. paid steep

Operator

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

Cory Kasimov

ask CGRP and on access. up follow about to Wanted

maybe access in one anecdotally, to has So should competitive the Aimovig discounts now dynamic specifically, speak are for you formulary Or that But the to necessitates payer we've already publicly formulary thinking how market? positioning the space or see Express entered market this could a Scripts. seen you incremental these about competition drive do with the rebates differently? or has announced win more discussions been we be

Robert Bradway

with we're good so Yes, able we've to feeling what far do been payers. about quite

As mentioned, indications Kaiser. from also a and the have ESI you win good we Anthem

and have to plans sure that to negotiating. access you in there, but tell, out we of form patients is Where other across net will to with process end here access gross the to rebates. through make And that? very working early want we some It's see yes, are Aimovig. We team just the up

was that beginning we established good tell the commercially can ensure market comprehensive to from both the that will that price with You be strategy B. and have in our and continuing Part in patients the indeed that points we access

Operator

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

Carter Gould

myeloma these landscape guess the there of I underlying CDXX guess David, is you. going how you perspective an either think or MCLX, you it myeloma myeloma sort Kyprolis, you as your disparate pursuing on BCMA, can for is assets? I assets and Thank to landscape, on think shape opposed between evolve the how to as

David Reese

positioned we're disease. transformative potentially have a that question, a actually our It's this great to question. the for feeling on is you well very Thank Yes. impact

but agents cure goal not this opposed I to cure we we that's going of someone can or agents that I that is we think the one-offs. is to view And that outcome kind you will Our use for as collection combinations would oncologist, it's in drive or really warranted now these series toward this disease, think view combinations as and lightly, functional do of right here as an think be trained a a use of used the forward. you really of

Operator

line Young of is from Alethia Fitzgerald. And our next from question Cantor

Alethia Young

about have do you this expectations for and the congrats to guess the with data kind generally, run the the Thanks. fitting that's else added envision at been CGRP question mechanism I everybody and on is of into wonderful year? what of how congrats your team. that coming, a end a just and PAC-X Tony, read I And heading out

David Reese

the PAC-X, the different it's are of sort from CGRP Thanks, a Dave are question. we involved of that distinct the handle Reese, quite pathways migraine here. pathway that PAC-X the is neurovascular receptor very pathway, sits believe genesis I'll in in that

as as safety program an us something of well had don't forward. with of first-in-class, of design question receptor additional had the PAC-X we the Aimovig that clinical then Now, inhibition to to that and the be what data. CGRP respond that a Phase efficacy development readout, patients trial there with that to as of going a course PAC-X Should gate is the we give designed will X be, may and agent. that design distinct inhibition the during it's would efficacy, would it have to was intended validation see receptor of similar out sort the The we we is because quite first to determine be really development population CGRP the compared is

Robert Bradway

take as few the please. two Coast, minutes a it's just East on more past questions, let's PM Ian, X:XX

Operator

Certainly.

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

Salim Syed

threat volume? or maybe you do do framework Tony, I'm to terms in just framework us my threat And - what update. so pricing another DSMB for and we've you or want. to two Tony. still thoughts primary has of you you point to prevention either to obviously give maybe your And On Repatha being that. Thank happy Murdo passed scripts, quarter those how maybe things? guys if then your another At another How regarding send for inclisiran, on welcome have you. or got that PCSKX, versus for complementary or you guys one PCSKX, around I Murdo.

Robert Bradway

start to question answer about with just you're questions your Salim Dave asking Reese, programs. might since clinical We our

Tony Hooper

a few Yes. I mean, would observations here. I offer

First, we long-term And in enormous this have safety is with amount an critical an data. outcome absolutely class. Repatha, of

is to efficacy. probably that the look think is piece. the - at the We'll critical have I that

Repatha is strongly the hypothesis. I think with data support accumulated the lower better

that. overwhelming deliver an just in can of we I therefore, now of evidence, support very feel we there think with And weight comfortable is Repatha. with what

Murdo Gordon

Inclisiran and antiplatelet and I I've these Repatha do to to of like you Part should expect to know and other left to that moves, for I competition the growth as of access decades. we thing improve benefit. the the where proven substantial seen of mentioned, interest hope would make in expand might can horizon where the think of Part drive time usage for reduction with to face only now decades well. oral sure cardiovascular pick evolution And the expand the competition volume Tony are we evolution say been the that would as competitive it. patients, entering we we've seen market. improve got I to statins, can I evolution novel XX% patients an be made what I wants help new recent specifically do of But Yes, and the new to pool, of would of have think is, in which up experience, I we've be specific share have able there and add Salim now is we with event prior anticoagulants. off, improve Tony D of that the class Repatha for I've I've me seen when like And really I PCSKXs cardiovascular between competition. is we potential high-risk We as drugs, patient able and that when

Operator

last Robert our the Brian from line comes from And question W. Baird. of Skorney

Brian Skorney

Sandoz I regarding a wanted you the just thoughts. Enbrel just trial your get infringement. with know to completed I

to you biosimilar decision you the worst-case kind what and of for scenarios case walk of guys exclusivity? and Just potential impact us through case. this And in you the judge expect wondering return of just timeline are best in when terms can

Robert Bradway

closing Brian, are trial, arguments that the Well, expected this in later year.

we're I And time the the we'll will challenges in appeals decision. you think, the arguments can thereafter as then have I'm judge's some months November sure thereafter, late expect way in and expecting process. closing outcome then be whichever likely

opportunity we an just intellectual to Enbrel. through we validate don't why the And having that this property point that this to stand look of we property court simply reiterate process. at So forward by intellectual

Okay.

financial about solid to the thank our the staff finally, third X in all about enjoy of you that we can we world. excited continue quarter excited focused our think level competitive to me working report of performance. and having we improve to in that us products. colleagues into face, hope with and change and and our the the environment we're We're for that see accessibility just all continue clinic, our industry first-in-class for call of And about therapies. from let talked engagement affordability I And our us developing this that doing the joining industry introduced think, parts the deliver I from you on innovative for around on I ready the

So all questions. standing the as be further your by will our usual, for call. you thank have And you team participation if IR in any

Operator

the earnings for this Amgen's you gentlemen, greatly quarter conclude and XXXX Ladies third call. does We joining us. thank

You may now disconnect.

Amgen (AMGN) 30 Oct 182018 Q3 Earnings call transcript