AMGN - Earnings call transcript Q1 2019

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Operator

My name is Ian and I will be your conference facilitator today for Amgen's First Quarter 2019 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speaker’s prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

begin. now may you Sood,

Arvind Sood

company Okay, BMO. thanks today to for us and of everybody. who Yaron of Werber of Good our first afternoon, Cowen, our coverage on their welcome Kim new Thanks Jay quarter Olsen are Oppenheimer, of joining Bill in Ian. including call. those Special

Bob our the record and will we by are business So a Bob’s we put and overview and having joined Meline execution, XXXX Chairman opportunities in place I'm results strategic prepared the of CFO after financial will our Bradway, in. for for challenges provide who quarter. go of into the review our environment a and our we ahead. strong track comments, CEO first well today David operate

will Global our R&D David Our Commercial review following our a Gordon, provide will Murdo Operations, pipeline Head then by of update. Reese of performance, product Head who

to separately. will guide link a our slides and have received today discussion We use you should

will Just presentation will a statements. reminder that be forward-looking the use non-GAAP some of and measures statements today's in financial we

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

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

Bob Bradway

presented growth mature expected we term. and over our as products opportunities the to long We Arvind, products the a and We grow me to by you, competition. emerging on ability in positioned feel all new against compete, well innovate, of improved call to track add our pipeline, Thank execution the of capitalize record entered newer now defend effectively Arvind’s let joining strong welcome you with and today. even our XXXX and an to

are faced success. for for for volume-driven competition. the volume challenged our of in like prices have are six around to hematology/oncology biosimilar will volumes, again have unit potential we, brands defend Prolia, world, believe upside in our as is cycle. we that as confident And our business quarter be believe important we and offset decade growth lifecycle a brands, our expect we strategies I biosimilar performance long-term well in newer the products As products our and growth newer our and We QX, in than long-term the once unit drive that growth their our demonstrated therefore, time place our management our generated products to of we the remain you Aimovig, life have competition of our know, ability erosion for some is mature and as that there to growth. to we being drug first products XX% early instructive. grow the more mature where especially outside Repatha, US, over phases attractive in considerable of said There, newer with

other more is year, Kanjinti opportunity know a remains Prolia, As compelling QX, Japan a millions biologics approvals million women in and from many a from international biosimilars we and are than underdiagnosed Europe annualizing undertreated starts in devastating need off in This which our a consequences to with month we're at to risk this are represents US. $XXX osteoporosis highly we capabilities. at earlier And world-class this them. the innovative In first of a bone portfolio added in potentially our at who osteoporosis. Amgevita now leader with of in take I which of women our think preventable. to leverage want select to markets. offering business strong moment products an and therapy for Postmenopausal with with for predictable benefit class disease forefront the that highlight and there's for to who medicines excited of and innovative fractures, health from to additional worldwide be to postmenopausal the fracture Evenity we may high innovative business,

we expect for product launches profile lower moving options. our contributions Murdo will cost important portfolio our on treatment detail making forward, revenue demand year especially discuss pricing to and see our in biosimilars this full shortly. increased drug We some creates other as pressure

to disease multiple rapidly a oncology therapies. on medicines, which as Looking class robust innovative as be a therapies and the of many pipeline our are across well we're of targeted the various of myeloma, portfolio solid or future, we AML, capitalizing BiTE areas best-in-class have in including to number industry-leading potential important In advancing first tumors. alone,

we're seeing. proof and you As, of from excited we're know, very rapidly to what move concept oncology registration, about can programs

our You'll hear Reese from Dave moment. on more pipeline a in

balance buybacks and sheet to around world. through volume-driven flow invest we enabled to shareholders us growth strong and returns dividends, has opportunities our the cash long-term, significant Our as in even provide

earn Our a wide with gives consistent solid shareholders. areas opportunities, of financial for strength the us also we our ensure to return consider to strategic ability development a business focus, while disciplined range remaining of

care, that harness access words Congress health with competitive advance also health for therapies reform better drug pricing. of innovation, we a of to continue to in the stated, more provide new improve policies power say to and encourage work patients. few with the and just access about and patients me Let the greater to administration marketplace, Simply that care favor we're and policies

to patients the out-of-pocket of administration's the lower last rebates. supportive benefits to year, are back-end from proposal seeing net patients. of we in experienced for of move as face declines, rebates costs discounts price order Even the we're not upfront example, to For in

to the move to which message, want us recent successes In challenges patients been and its advantage I the in with long-term transformation and have resources need with to to which front fact, rule. years, that on take will the final and close we opportunities determination one for to recent final of just costs out-of-pocket competitive rising is many our build our have forward for in meet growth. the underscores deliver administration of

remarks first his the on to quarter. share invite David Now, let me

David Meline

Bob. Okay, thanks

we of investment company first globally, growth increased The for we growth volume digit quarter. another delivered EPS first period quarter year-over-year delivered and marked the solid business mid-single in as in while the performance the non-GAAP

revenues of unit royalty the newer products, first six over declines slide in page small our molecule were worldwide on deck, sales strong increased in products by Sensipar. worldwide offset results financial XX demand was product generic of mature year for our at by the year X% billion against including the as to declining quarter, million, XXX revenues million with X.X billion, Other driven X.X Turning income growth. competition

As make contributed operating to we income XX% result increased non-GAAP non-GAAP advance This by year. percent investments our than manufacturing rapidly product basis, at of maximize previous our non-GAAP sales operating products, X over year. to sales offset X% pipeline increased of our also lower marketed a partially expenses mix, cost and by to XX.X%, and On royalty driven our continue innovative as of points the value incremental to product year lower expense. costs higher a by

full sales As to expense on be quarter, for expect to continue sales last up mentioned volume. year, flat year depending cost the we of to year over

the expense of First expenses oncology multiple product quarter higher development differentiated sales XX.X% XXX in for a due percent of and and Research investments research of early-stage quarter. to development as support million programs. XX% increased was our were

year-over-year rise our For single-digit basis newly the for Amgevita on an and basis, expenses driven terms launched full Evenity, to products, in R&D absolute our Kanjinti. percentage support year, we primarily in expect spend Aimovig, on including increased SG&A XXXX. by currently biosimilar a X% and

absolute initial the our expect We to normalize, XXXX track as expenses meet we spend versus on basis. to operating our continued resource decline year, discipline. we guidance For continue inline full to remain launch expense of an SG&A on with and XXXX allocation

Our line operating net several income portfolio; that our and expense appropriate million factors, three, rapid we important anticipates presence our continue and we including in make we support tax programs; over million investments to from the program; to over US percentage innovative X% earnings and reform. that favorable benefit increase two, This continue a XX% XX.X% in sales our to to one, due that quarter advance non-GAAP guidance we fourth, points, growth. benefit inter-company of increased by productivity increase year basis. expense our and expenses volume were experiencing biosimilar for where are that non-GAAP XXX XX we global $X.XX tax associated under the per rate share. X.X for year The on share of is tax prior a income an primarily corporate year year QX. declined Non-GAAP quarter, in year first was Other net with per

second flow first annual tax that a customers quarter payments sales to Turning I tax paid was QX flow driven higher deductions to approximately payment. balance sales. cash XXXX by and year of on an income Free lower last make next in as including will fourth quarter and was than seven. net dollars, our billion on billion. we page third X.X one-time cash increase lower note the be negatively impacted repatriation This sheet following

returns commitments, an price consistent deployed X XX.X shares shareholders, continue million billion of to at We repurchase QX with $XXX significant cash to a to share. average our as provide per in we

an shares Given QX. billion to of we billion repurchase plan our in to incremental X.X price, attractive share our X

Additionally, XX.X approximately $X.X per decrease our over first investments an billion, last share, last quarter dividend year. a quarter increased of increase to X.X Cash first from of totaled the billion and year. of XX%

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

track with drive for business outlook programs, XXXX presence, our XXXX advance out grow. to guidance. invest continue on global the our on page performance, to QX our raising eight, build to plans our light long-term we Turning volume pipeline, our In remain the of are our we for early oncology including to and

XX% share. competition the our to billion continues outcomes the per earnings of outlook to $XX.XX competitive associated Our expect previous billion dynamics update. over well to XX.X This concludes now capital to I of the the XX.X of tax non-GAAP $XX.XX versus and Murdo. continue generic million guidance, we as per to related $XX.XX to per rest our year. will to revised This expenditures share XX% $XX.XX guidance as Further, of rate XX.X versus revenue previous we're share with financial of of billion Sensipar range this to maintaining guidance the inline With we're reflect to regard turn evolving is XX.X guidance portfolio. call guidance the our $XXX non-GAAP to approximately to revising billion.

Murdo Gordon

Thanks, everyone. David good and afternoon

XX while We're start solid management and on lifecycle information our we sales XXXX growth driven XX. product more of slides newer off successfully find volume our in portfolio a to with strategies across brands. in starting continued execute mature You'll products,

quarter Moving results, with on first to let slide repatha XX. start me

with year-over-year PCSKX of want breadth than step as current we in lower year-over-year, Given to prescribing hold prospects. make increasing growth unit of by following was The Worldwide available our class. confidence introduction to provide by The Repatha. in co-insurance XX% list QX primary lower the lower and increasing and nature prescribing to performance patients is fulfillment fixed Medicare, price share available and by cardiologists, care detail on leading some the the lower In unit majority price attributable XX% to PCSKX list of price growth class is growth patient XX% a at a more Repatha the physicians, seniors. its version Repatha, US. grew growth Part is dynamic copay the now I the to depth list of structure. increasing XX% sales next the D versus of

a expected next of at XXXX. low Currently, as level patients it's Part underway, is X% $XX. of Medicare this update D for above improve copay fixed early only plans are year While to

approval covered secure management by improved improved we patients year-over-year, payer insurance, through to have criteria as continue commercial utilization points XX contracting. For by rates

regard Prolia market, and We that we annual our Repatha. benefit net Repatha strong help large with optimistic in work effect and And more the to declined work we PBMs with of country patients the between growth longer will contracts in now volume China. that US beginning to continue and will sales the blended pleased health our US which in term. net see positive the QX get price Outside first administration in to original our to see we the for a took With remain price are with US, on to in could to XXXX. list to optimize of the over plans, launch reported be impact priority quarter ever population XX% access to lower due authorities Prolia We're pricing, the growth. can Repatha January. year-over-year, Repatha sales Onto another committed of XX. we sufficient discontinue increasing remains by XX% slide cardiovascular driven that risk underserved coverage to the Overall, rapidly. from price and continue delivered patients on high volume with list

the his than indicating a patient and the pattern representing a X Japan sales months with our opportunity our exhibits improved global month we recent patients very and in growth decade dosing penetration US Astellas. fractures diagnosis partners, alone, in and for of diagnosed the US UCB and million population fewer QX to EVENITY and given take As ago. reminder, given for convenient reach launches The expect administer Overall its QX, health epidemic, conjunction with In QX calls position XX treatment. to are treated potential aging market the Organization has by Prolia population, will through and unique in remain a only strengthens as significant molecules Health lower QX. consistent direct Amgen’s osteoporosis and interval, there sales six the once-monthly bone investment, that range, like costs Prolia than World responsible XXXX. With $XX the the with two is osteoporosis seasonal is mid-XX% a increasing innovative driver. to billion and and physician complementary. a approval the annual profile US comment of on year are I'd in for osteoporosis EVENITY and leading highly dosing in are expected addressable of

to ability this our in market. confident are to We continue penetrate

Our promoting with Japan launch through our start. already a is sales the Meanwhile, force and product. in our is venture Astellas to joint off is strong US trained

take the medications to for Now There To alone X who unmet the need in XX. individuals slide migraine approximately Aimovig for is preventative US migraines. substantial. on million on are begin,

compliance is a opportunity low. only now growth remains patients Aimovig for as XXX,XXX the in it However, is the CGRP a Approximately as new US than a launched it tried discontinue XX% after ago, therapy overall year. market and significant penetration have low since less of year

given QX. increasing market the We considerably in prescribed for sequential CGRP since launch. over Prescriber TRX growth now is Aimovig to breath expand expect XX,XXX have this number inhibitors consistently as XX% physicians

primary the date. encouraged to steadily particularly rising, prescribers We’re care nearly XXXX is with adoption

also We awareness for consumer direct increasing to have launched patient that indicators recently our is program Aimovig.

take understand me a performance let Now, to few you in help Aimovig’s QX. minutes

and prescriptions plans. strong brand the share new XX% the rates new is market of for Part patients access XX% with leader conditions total exiting share and with both of from Medicare Aimovig Amgen approval XX% prescriptions, First, over market QX. D to benefits commercial in

business XX%. Recall net of Regarding that list of near at the a first of end we price. at of commercial experienced of Currently, a and under is the the early that contract launch discounts proportion proportion net reimbursed result the selling the during decline, majority the product, paid of prescriptions phase XX% Meanwhile, free our prices, versus to paid the quarter. is were two receiving dynamics. increased prescriptions near

product to share. Looking while forward, free in offerings patient we see expect competing growth, market. CGRP to for Aimovig market effectively will the competing Offsetting persistence continue strong dynamic, this, given be

been made. coverage We have decisions expect a net stabilize XXXX as to of in majority prices

proportion decline for to further in recent the the lives Additionally, of Aimovig the to remainder confident of will impact auto experience. of the the continue milligram injector XXX potential and the over enhance patient free XXXX. We're positively single prescriptions patient launch should

Oncology our year-over-year. the $X.X in quarter, XGEVA, IMLYGIC to Hematology Nplate, Moving growing portfolio Vectibix, the BLINCYTO Kyprolis, X% collectively and business, totaled of and billion

recently reinforcing above in revised prostate preferred slide status US. cancer XX. XGEVA NCCN volume in portfolio, of just see the In indication. on start in the XGEVA this recently grew over primarily with X% Looking superiority the at as to acid some XGEVA castration for larger this gradually brands from zoledronic increasing let's guidelines, additional year-over-year within details, XX% share We in received QX, we resistance

by driven markets had year-on-year growth. key US, the which primarily XX% in growth grew which Kyprolis, including to XX% Moving

emphasize are of XX% Our team from XX Kyprolis changes sales adoption points to to the of year-over-year, offset in and weekly Enbrel, to changes. point the from benefit, share overall continues dose X On once estimates was survival US. which by unfavorable we impact to Kyprolis inventory pleased X% close a X% positive of see included increased approaching which increased non-recurring, in partially accounting of use

X% XX% in by benefit the full quarter, for the which net accelerated a the growth market persist the versus we expect to recognized average rheumatology on and from quarters. limited trends last price over eight year. QX, we continued Share During selling

the Enbrel, which to device, from touch, multi-use continue a Enbrel We continues mini invest receive in Auto including positive feedback and patients. with to physicians

our the also we're are QX will should long to now XX% prepared at in Europe US Medicare segment. additional share entrants XXXX, sales for competitors BARDA. sales to entrance US, with to and likely account $XX Neulasta US they as filgrastim establish share million we Onpro XX%. lives we Onpro remains clinics sized We lives approximately biosimilar that commercial on additional pace receive serve quality, the acting solutions of In declined and XX% experienced More supply, in approval. the XX% coverage competition confident holding Outside the segment Next three number the year-over-year countries expect of acting brands as compete by XX. record a of our from QX and XX% well accelerate us which client. seeing a of slide Currently, with starting close year-over-year, will which of XX% in such face during exited Neulasta non-XXXb XXXX, account. remain innovative strong with of and We dependable of broadly, in the of in included hospitals and Insurance QX, covered. medium close purchase long small of declined increased

system Switching of meaningfully. Neupogen and segment. Since acting down QX quarter the lower declined slide the Neupogen ’XX, the short QX filgrastim Neupogen roughly Epogen US, on the have $XX costs healthcare XX, from to sales due of results biosimilars net exited share short benefited in adjustments US in accounting sequentially million introduction XX% come nephrology Turning QX XX% XX, to sales to slide price. with starting of acting million for to $X were selling the first

first The approximately end quarter large purchases. of million from customer $XX benefited

Epogen decline pricing increased lower due net with contractual by will to commitments declined year-over-year for in DaVita, competition. X% volume our continue to driven Given QX, Aranesp price in XXXX.

mid-sized at US. independent solid utilize continue and of in Parsabiv long the in rate Aranesp DaVita gradually XXXX to patients, a decline with versus We acting adoption. expect emetic FMC and both their to and experience XXXX are providers to competition short continues while acting a for sales calcium Parsabiv dialysis majority increasing faster growth,

Turning a as to $XXX of risk on than you generic at can recent see Sensipar, XX, that some result small million lower are molecule slide US sales launches QX quarters. our significantly of

Given to sales launches than be occurred, QX US the QX. these at intrusion have risk now in of that expect we lower

portfolio by quality patients. performance in as a forward, highlighting Amgen of also pleased of strong the from I'm periods. uptake next our European to assets of number XXXX. I'm product prepared and and In of of of dedication presence and value maximize products like portfolio planning bring to market and We're mature our KANJINTI who of the launches services anticipated. with of forward be the demonstrating the this new dependent the inventory now to proceedings where biosimilars the our and we brands. establishing and performance biosimilars for confident driving value the AMGEVITA our for to execution Going Amgen’s in the of supply. team, we health and will appreciate outcome are few bringing patients over of high these the that strong We're growth legal greater to launches is progressing close new rate volume a We're summary, customers system. opportunities on products, evolves across with care to consumption generic look years as multiple successfully launching the solid the I'd our

let turn it Now, me Dave over to Reese.

David Reese

with to afternoon, everyone. begin across a with in rapid I'll our to and and pipeline. exciting Murdo good progress portfolio. R&D Thanks, We're off XXXX our oncology start

dose with we first platform AMG a hematologic update We or our in at trial malignancies, generation BiTE molecule, of an BCMA the ASCO, will In BiTE approximately escalation continue molecules provide to to XXX. our close clinic. dozen advance the on now

a We are now dose enrolling in patients study. expansion

BiTE BiTE and We also expect the of by from end new BCMA half with life AMGXXX data molecule. our clinical some the extended of generation the platform year first

was first Other and to specifically BiTE Our study is enthusiasm tumors, as impact XXX BCMA and a and data therapies molecules meaningful presentations expressed a to human our a introduced they prostate as treatment well T-cell on our escalation. We briskly had in programs that target myeloma. bispecific molecule tumors. is AMG commitment our for in escalation against through solid clinical PSMA, of This we we proof specific study new MCLX acquisition. the of of can engager for antigen, Micromet testing high a approach AMG majority AMG trial Bayer at XXX, the ASCO our prostate prostate of membrane have bispecific cancer. pursue for which conducted in develop molecule, BiTE from multiple clinical as concept is the into make dose BiTE now half-life through XXX, prior or believe highly directed this the include by will human and extended CDXX with dose license provide progressing the

for we and occurs a intriguing data I'd BiTE to checkpoint could we this we biologic have between sharing T-cell trials Based are note in improving to into in XX its enhanced of medicinal an accelerating the extended spoken on like and past rationale a is in form the on two mutation case, of cancer. of a locks the KRAS RAS target oncogene When group, and KRAS with design we adenocarcinomas, at of well early up non-small XXX a year. inhibitor. to seen evidence development has BLINCYTO, these and to binding under shallow exploration molecule preclinical a a BiTE combination. key combination to advanced about in active that molecule we clinical discovery of GXXC had early about example. we so. traditional cell this I've and which human We knew accrue it cancers half-life background, our we PDX By of BiTE insights, various studies occurs will which allowed on common excellent AMG Recently, to irreversible substantial in of It larger program, for way of anticipate of accelerated elegant of and drug as been have due of generation this set clinical other are state. providing development great the here protein. first about a GXXC Amgen, on colon our KRAS As lack a of and human in the more undruggable program BiTE we it XX% turn but low percent AMG extended with X% pancreatic mutations programs. also lung to our There's molecule inactive frequency year most tumors given the halfway initiate over activity regulation identified within targets years, first or molecule, lung that if programs data. potentially PDX was the of when in small un-druggable cancers, cancers. at efficacy a and an been preferentially since development, chemistry inhibitor and comparable RAS One have safety couple of first many the of of both GXXC in in the final from the evidence produces activation an observe specific small all advance clinical XXX. pockets productivity of molecules incorporating program XX% that how leads that access, to generate mutation combinations inhibitor very us for occur we as The through I'll one interest, a inhibitor and we remained on oncogene, timelines and all now into say the formats. a

a we specific that dosed a presentations characteristics highly Our good AACR have that with at molecule orally day. can like demonstrated once drug be

models mutations in may interest act look other preclinical X in tumors, and up forward part in will data share KRAS to by expect initial the containing patients enhance also in-human MHC particular GXXC preclinical first agents, class lot hosting data meeting We the inflamed inhibition. our dose inflamed to with of AMG exposure showed here also we XXX available. an And safety ASCO the in that be the that should investor we've been the We have is I where questions what and upcoming of at with to AMG cumulative tumors data you on the Chicago study say would be sensitivity that will There efficacy data where solid a XXX expression a escalation event. opportunity checkpoint date. the to data got basic from synergistically extent regulating and

we've in enrollment the expanding been dose months, only dose. target about eight clinic and the have completed escalation While for at are we

a therapies. our will medical our XXX the forward, I've and And in preclinical the you on inhibitor work on clinical data on study. currently forward Moving moving we're ASCO. for potential early AMG AMG investigators, Based need, many at with described to to XXX we feedback a also from to of PDX expansion the with combination and combination targeted optimistic seeing in be and checkpoint inhibitors address ahead very exploring based unmet look are include we various

XXX AML after inhibitor, we in seeing inhibitor strong a synergy. [indiscernible] AMG plus through escalation and AMG patients lymphoma, MCLX intravenous oncology, rapidly We're of dose preclinical l our recently with in also study non-Hodgkin’s oral began recruiting malignancies. XXX, in of patients combination MCLX evidence hematologic Finally, in advancing our

programs several accompanying presentation, portfolio. these later initial you find overview our from of data hematology clinical We other expect programs. our year, with oncology clinical In can an this along

extent, approximately epidemic of bone the in a we characteristics therapy disease therapeutic per of to approval a societies type based remains and disease in Postmenopausal dual diagnosed bone receive post million it States first unique that at alone. EVENITY fragility to a health, effect pleased US fracture high risk the Moving United history is resorption. or Despite undertreated women fracture. treatment EVENITY receiving affects silent the of of our are for Murdo the year as to formation X only these with that world, a only under around bone of areas, any fracture. in XX% women noted other the and, women increases leader in with and lesser leads on a as to postmenopausal this, for both treatment fractures anabolic an and osteoporosis osteoporosis reduces osteoporosis,

need the density for later stage heart or received our noted, progress syringe heart for elevated indication and sharing in anticipate auto due For to milligram for rapidly year. an symptomatic filled our months in as particular, migraine, first fracture, expect or pre six LP(a) a US. with in EVENITY we disability. breaks next rhythm passed reduce bone injector, a mecarbil siRNA cardiomyopathy also outcomes we cardiovascular the to symptomatic sinus interim recently treatment or In no with Aimovig and an in and with this pediatric rate. XX increase often of failure that year the subsequent clinical Corlanor single approval And to of the Murdo cardiovascular XXX phase early study. are lead fractures to We months, patients of who to study mineral risk who patients mid-year in futility and analysis our finally, continues X AMG Omecamtiv disease, older in recently we recommended by changes data the enrollment XXX stable complete dilated can received

thanking staff pleased phase X XXX a Bob? and for I’ll close atopic for report enrolling enrolling or ABP phase began deliver pipeline is study that study by to patients. we with X I'm Tezepelumab. exciting continuing to inflammation, dermatitis patients. advancing our our our for biosimilar Following also our

Bob Bradway

you. thank Okay,

now open And Let's for the line I procedures you operator our perhaps, can what questions. up questions. Thanks. ask remind the submitting for your are to

Operator

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

Matthew Harrison

Dave, two was ask hoping to KRAS. part I on a

that, enrollment there such through factors Thanks. MTD is, with we you or with should here efficacy And the first the pushing combinations? So you fact other what at view those I you rapidly. you're play? thing seen can you with that efficacy Is you've that or because PDX? progressed faster expecting, is are drive As period hit of than think below substantially dose monotherapy seems it how guess faster combinations then the higher were do you that fairly escalation the the like were part forward as expecting you've

Bob Bradway

the Matt, for Thanks, questions the KRAS around program.

Let me them in take order.

have I In We to the quickly trial, through a think data phase in will present we escalation on clinical lung very able on had tolerability. the at ASCO. planned X other of we move escalation, of of had terms dose based based We dose and were centers, of that the patients fraction a able to cancers is that quite eight enrollment along we're at pleased been in and most population brisk a to in months, our pre-identification tumors. move

investigate we're both combinations as the a In described I've KRAS inhibitor, moving of quickly data terms monotherapy expression, as of we other of inflaming not forward X the combination, preclinical either terms will in to I these It’s find may in of MHC as early clinical think but only with the based the indicated on molecules based on I and move of and setting, home on components the tumors, we've days, and also before, PD-LX approaches pathway. some generated data inhibitors these the combination. that upregulating or be

all what I've I as of quickly will forward. pieces explore going Amgen. moving of be here those program as at almost is seen we This any ever So think

Operator

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

Terence Flynn

would anticipate love B do remain you project. you Thanks perspective proposal your lot. Maybe IPI Bob particular, could proposed a could demonstration changes? that there expect on here, be do any Part the In the just

Bob Bradway

rule your interested concerned were administration in proposal. concern a implies, access patient and choice expressed potential wide bit that a to to concerned Terence like It as from patient quite a that groups received it's including question physician surprise seeing and by enabled like and X,XXX range you different it, about the of and won't a innovative about groups, medicines groups We're not commentary rule that physician we're has the as new and know quite proposed well. impaired of Well, something comments this. we've that

access in the medicines patients later. the available have compare of new I XX% months think others to XX and the XX% available expressed medicines the just at States to you same they're innovative France, And by if administration. industry are look very the cancer of that have where that medicines the fact, to and patients we if US, about you in United in situation So here innovative Medicare And rapidly, France. in the cancer, to in compares some being way, available the in

in patient, the death. between and life can mean a cancer So difference that

been over favor So Having diminishing of we're think the of we'd we effect concerns innovation that the innovation to and administration we continue said address help and like investments a that, impairing that. have other that long to have the in rule in proposals do the not might working can with around to access this administration, of the term. like

to the they prices the that think could administration to government and things enable would get we some physicians the use are are that market and So medicines diseases. think the there pursue access patients these that appropriate to enable for still

Operator

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

Ying Huang

My question do has trend. Neulasta to the first with

you update you price of So Neulasta? units trend by is up so rest on math, went pricing came by XX%. Enbrel my net X%, for year roughly the by down down X, the an against went then on provide ruling by for probably year-over-year, XX%, down Sandoz. Can And comment quickly sales the patent the coming inventory can the

Murdo Gordon

perhaps first to Bob the take then I'll Sandoz about Enbrel. Ying, and talk the one other So question ask I'll and regarding

holding market XX% we long how against is overall, in In of think I business, particular, Neulasta. durability Onpro franchise. competitors performing two the which see despite acting around we're the of at share filgrastim with biosimilar pleased our good we're

account to of drive will account closely price we're that share continue competitive significant going forward. potentially further by and also an new as level, following is What compete point the erosion erosion and out at you very number We entrants, and defend volumes. we

Bob Bradway

case, new report. nothing court to the On

nothing we're know, to there. you As waiting and for new the report judge to rule

Operator

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

Geoffrey Porges

you much. compare And to KRAS, how of Thank you could question, the just intervention understand new in first Aimovig you us just terms in bit particular, terms or does could prescriptions. the the give as David, -- particular out color event the expectations, we're should is to treatment this response in of on new of how look very in that this has help quarter to in in mutations of Is Thanks. of down that cancer Murdo, as those us it lung you one-time be we're little there first For secondly, EGFR, mutations? then data for step accustomed a some baseline? pressure come example, though is more if as other And been seeing? you've to a share like on it prescription contract, canonical and seeing that likely because if a just the

David Meline

ahead start biology. go the I'll and question Sure, KRAS with regarding

probably present, and suite are molecular I no tumors, or other think, another Jeff. this that, trunk activity will need you based driver there's expect some be alterations well we tumors of mutation, in a monotherapy approach. answer that combinations mutation for other In specific the a mutation, may on may

forward on to molecular we out things we I extensive tumors profiling as resistance. to predictors where out response will and think sort these we'll the try move best are of be the sort all doing

Murdo Gordon

continue considering effectively we for feel good the new continue Jeff, grow migraine, and opportunity Yeah, prescription base compete in to about to unmet the huge share. to need and to

XX% with still XX% TRx the NBRx we're know, share. you leader around As market share, a

and continue We we insurance of paying increases that have good the for patients in D to commercial Part across coverage And benefits. drive Medicare their are percent Aimovig nice through payers. commercial

our then some also understand XX% the in are free the the the real We the drug bolus in effect We're forward. clinical trying was is paid of into to total patients we seeing move XX% the So to saw when trials, that we'll what we persistence our that of between trends, launched through is see what in we first it transition. working looking category. up secured prescriptions how be in in CGRP we and market that world to shapes as and

Operator

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

Kennen Mackay

prior in forward how in evolved? you'd derm, question, mentioned and the AD tezepelumab R&D phase about sort what this high has thinking how difference in primary moving important the hadn't Quick Xa X a missed this, you're phase Tezepelumab and atopic of

Murdo Gordon

Yeah.

on disease think gained is the of approach and background a the also waning has the the I greater that understanding disease, history. to medications. and This natural variants waxing we've a

study that rigorously designed AD. will And so, in Tezepelumab we think partners, the our utility we with have, phase evaluate have X a subsequent of

Operator

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

Carter Gould

in this, [indiscernible]? making, futility second, ask then change on a specifically, And analyses may any really I think pace progress Omecamtiv want efficacy. or thoughts how initial are maybe been you've your for for stopping to interim the be the there alongside for on this planned just if either positioned one maybe HF, you additional

David Meline

Dave. Sure. take This I'll is that question.

communicate event might So, as data. typically are these the efficacy. driven, expect we will are and They time at there analyses trials, in appropriate interim we for those

that many to is orthogonal be I failure. heart the to drug think advanced of of the to To able should existing novel, its about things of us it's background Omecamtiv be the one and existing of that me, of therapies. think great the excites one attractions mechanism we potential therapies action for is added that's

Operator

our And and Werber next of line Cowen from is the question Yaron from Company.

Yaron Werber

Great. you. Thank

bit doing us Or patient well? I quick David, on a Sensipar. little would also escalation? So three by break a can question And a I've are results sense, on this three then out up And a you the of tumor by follow KRAS, a was give escalation? you as type typical have into you dose

David Reese

of a to ask questions all second provide say our phase second their answered detail out at Yeah, question? Sensipar? thunder, in X to what will your but Wanted was get don't the steal great be investigators front those about presentation. ASCO. want will I'll and I And, question What in is

Yaron Werber

launchers they the Are for are up coming the sense? subject June? [indiscernible] a us are litigation to and give you Sensipar, still in in Can they

David Meline

what I'd Meline. Yeah, say, so this is

to of course, is have coming And we around, by here conclude offered fact And first or will for reason is, not. that it's and look the is, this that it's narrower, if at bit you what year we litigation the uncertainty that So launches we driven afternoon, the expect do the is guidance while going still point the months. you we've a we this on still that in quite given have sometime that's that additional broad.

breath So, hence the of the guidance.

Operator

our And from from Capital BMO Do is Kim of question next Markets. line the

Do Kim

seeing do the European to ask landscape Europe. biosimilars market the biosimilar out for But the market that how are out Humira know your so you Humira competitors? with how will and with shape many wanted there, many about fairly you mature. position in in competitors so how I We biosimilar is

Murdo Gordon

you, biosimilar is in the biosimilars the of Do What Murdo. penetration of Europe innovator in rapid penetration of the the categories. seeing across Thank is more a biosimilars so in in market question. compound, general higher This for Yeah. we're general number different

line shares with a we are had anticipated lower. less in and what more little or is Our price

you're interest revenue on and at volume higher better a news national in What time the little broader business driver we're marketplace case the of the read seeing lower significant holding and come. bit for somewhat to prices some biosimilar formularies prices at smaller regional and Most pretty significant offsetting to have foresee all to the about were in and those price winner up due seeing particularly are that we prices quite a related prices And penetration, some of takes level well be markets. formulary the in to European biosimilar be So the to that you tender reductions. were the careful. pricing, we Humira

Operator

from And Jay from of question Olson is our next the line Oppenheimer.

Jay Olson

in about week trial then Aimovig. long for on separately, out Thank term should the Can for differences and Fourier be next how impact Repatha. of VESALIUS-CV Repatha? data key the for this outcomes study we curious at trial for I'm between may looking on comment trial commercial potential And AAN terms the anything outcomes you. that and you

David Reese

I take Aimovig that address other Well, Repatha and the and half get the can one I'll AAN. of Murdo will at then question

coronary Murdo, of were on that, population risk. may are add So commercial with it but essentially to It's evidence in that think so the what an the trial. have VESALIUS, the of Fourier high another a target the very population numbers We they studied disease, should have in beyond millions terms high with we Repatha in known are patients component. body these not population. to want you had in event, known, risk we comment artery the substantial who

Murdo Gordon

patient to hard cardiovascular high penetrate work and that to compete continuing risk in that we’re category. population Yeah,

understanding really data We volume the more different than are similar more public the we've patients. XX%, XX% that already domain. we're value believe physicians with the more and are risk to And higher seeing had pleased and to are the of continue what in evolution cardiovascular treating we these

David Reese

month. Academy at for are show to the per days substantial per patients, clinical meaning fewer The episodic who have In Aimovig term now. four And we in for abstracts we were a data the interested X to depending than migraine of do are of and on chronic I chronic number and able what per two-thirds these Neurology reduced of days XX as And That's migraine example, safety both population average, you migraine, were terms episodic impact some patients long very or migraine. the is able five days, meeting, dose, to are convert American on then which up starting headache those XX very for month in that by migraine, and data interesting imagine. was data, to month. of think days roughly the efficacy in can

within out coming week the so. are next data those So or

Bob Bradway

single dose. data the Those the support new launch XXX of milligram also

to that even higher dose So got in they who to conversion. patients tends that give better do on

David Reese

remarkable there are, which complete those in is this disease. in responders, And Right. patients,

Operator

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

Michael Yee

or know for Good related reason what on afternoon. somewhat was that in a a to the comment guess shareholders does are Enbrel, issues, the ask know? I then Hey, the just you to same if thanks ongoing surprising your some people. company. for to implications? go the related not with thing the maybe litigation can to And should Aimovig, And that scenarios question IP litigation some to the for One the I favor what on wanted bit question. two are separate reason is, for we

what on there. so comment just are Thanks maybe So much. the implications

Bob Bradway

can understand Yeah, I sure, Mike. that.

presented. we one, strongly that about first the pretty was case On feel IP the

patients this. that in in to And about for But why right resolution have immediately the if are the contract it's would had underscore against options committed judgment obviously, to and what's field this that's a matter. look, a dispute teams dispute go unfortunate the is so doing specified partner us, were thing we here But to with we our like Aimovig appeal. first the on that we partnership,

that feel our partner is a enabling So competitor product. we

those that time. will play a pursue And patients committed both benefit continuing this and from are. so out I we who are we the for said, therapy matter in to where over want it. teams that pursue meanwhile, as period in But courts, to probably to that's And of

Operator

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

Alethia Young

but out term how bit I biosimilars market, have attractive you put a you we the potential billion thinking a about to are because little had talk business, now that the about takes about of it’s just wanted frame that kind the I kind I biosimilars around know some longer the longer of about just you've of you X term wanted that and think same, value prospects, some in guidance puts of the number, business? just guys want less do we think can to more the attractive a

Bob Bradway

and that what think comments to in solid we market Historically, is, European change the in and continue not we've the on continue pursue US the the we and experience in it's early continue I molecules interesting future. based launches up. number we still the really days prepare And they Obviously, long believe in distant our US, range a to of still hold made. outlook very the too wouldn't to US for

Operator

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

Cory Kasimov

could fact Aimovig assuming I'm on is issue. some be competitors this alleviate that you on to ask this guess and issue I wondered color might you the leads and your drug. docs discontinuations wondering to provide talk and with to frequently it about constipation wanted an in if even I some doing what how this,

Murdo Gordon

stated net the this And issue. question. we support and also been of in that follow of up our it'll this rhetoric constipation, incidence support making around issue, always AAN. around at part even necessary performed the we on how sure trials, we're our in Yeah, amount provide physician We there's safety large product the that's product. one, label, the and given the But a hear about do long obviously think thanks reported this patient be clinical term for quite created data of

are characterized I it's well designed been Aimovig so relatively and well little telling they have patients think headache low on that persisting. trials. trouble in in having a it's many the good, We're and And started particularly very us pleased that continuous large clinical scale physicians, the centers, incidence, and that prescribers also

other different And concluded you looking that some for moving in function another. just, the that than of have perhaps other of and clinical in small persistence are our we're things think, an that not were I that's from market given to seeing a many are obviously, switching are from months function people pursuing the we what effects to is persistence at of earlier it entire trial free trials. a continuing insurance. patient are population who competition, mentioned commercial we both questioner it's I might one in that And response to the without component some who offer a people seeing there's away And of agents.

us actually patients to XX month durability. still That a XX look the puts Aimovig understanding there's that and take month to of before on your able it will timeframe we'll you need an months XX how least are evolving discontinuation So persistent understand of many question to ascertain at be in back period. to

David Reese

incidence? clinical view see we they hear what physicians at They would that clinically a really a don't And it of barrier any experts from is Murdo Cory perspective, it from said, low at as all. I what manageable. It's reiterate sort quite

Operator

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

Geoffrey Meacham

evidence studies, presumably But dependent, you're in pipeline cetera. pipeline, the is Broadly Thanks. I Just dose for was had know for a to into wasn't phase this with et PSMA, sure or moving KRAS, for path just a some on even had been escalation if there option registration it's data regulators rapidly BCMA, this. Dave. and if on efficacy pivotal of you’ve discussions X, I had earlier for question still but there it's an the even

Murdo Gordon

the But be dose program. in in would through phases quickly by then say program into our program. vary to programs expansion that'll course, general and is will can of these what pivotal move we goal escalation Yeah, potentially as of and that I as move

many that's diseases of think I the expectation. how development And given realistic paths, potential planned a the target and clinical regulatory programs. that's the we've

Operator

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

Umer Raffat

intend you curious for go to based ask, Enbrel, accounting wanted on quarter for Thank And also dose? expecting this Should was I preclinical to data, you efficacy first in seeing the you. the treatment? in have saw back the KRAS at response? then year-over-year second price ASCO is we a expected show? dose a and or by basically adjusting to cumulative quick everything on And net mentioned again what you what be do trend third you MTD the hit would separately was to fourth

David Meline

Okay.

I think questions, there several were Umer.

David Reese

of escalation is inhibit dosing ASCO. a a that target the course the present will irreversible present, I And period in to comment KRAS, so data that, dose probably is details is that adequate for exposure few time, interval to say at day achieving mind and goal poison with month again and In signaling and over the will about a clinical a won't will an anticipation a of hours specifics planned I our in our the was on this of relation dose complete response. inhibitor. adequate so

Murdo Gordon

some And have on was net strong as It as a by and quarter price Umer, benefit strong Year. primarily Enbrel, on we price the contracts improved did across in on a New based your regarding did driven question increase see we market well rheumatology, Enbrel. that

Operator

Gal Bernstein. Our from of is the line question next from Ronny

Ronny Gal

I if may. Two

you there put I'm wondering Aimovig, us if then -- about payers can to there, to pricing comment. on coming First, seems you’re their was a wouldn't mentioned and this that molecules Amgevita, the that at wondering context? really in down And trying this selected step about you stabilization track preferred out of added, Murdo, for agents Kanjinti those molecule break I net at sales have It like can they relative not I with price just of comment secondly, you be of so kind was this the year pricing if orals individually. the as and keep expected another just out, that and when so point, just agency cause even another in down prefer I choose step wouldn’t expecting

Murdo Gordon

be net with going the recall, Thanks, also, sales has reduction price to We're two you not but comment, it. volatile trends are as biosimilar both We're happy a Still that by both at if two on would the throughout Ronny. And I the forward. at additional yet. One we that contracts breaking Aimovig, this components plus brand to on price, that year, products my look is percentage of you based could rising the market, the my question. least stable for occur your to one course of a think another, offsetting prescriptions a year. are and leading that paid clarification

Arvind Sood

will one and question closing some Bob afterwards take comments. last make Let’s

Operator

And from Syed question Salim the from Mizuho Securities. last our is of line

Salim Syed

I almost we long line we that of to as give guess a of maybe thinking some designer what the color that like I term And value multipart of the as trial us trial. seems Repatha, me, was, for genesis proposition sales? on Repatha just should medicines guess one be you marketplace the it one on CVOT a new line. companies could think of in on mimic validation given if the for about

David Meline

calculations that go for anyone wouldn't study, design it target template any of based go magnitude population, typical that validation a trial call the that that I'll using from in we and that's, that study, that the weren't clinical from the alone. but Yeah. perspectives on happy effect, I design study, we results consistent of anything technical mean, all study expected address else’s into way design, trials, we question. internally I statistical a be of perspective, to just

Arvind Sood

make closing comments? like some would you Bob, to

Bob Bradway

closing, XXXX. for you. in start long enthusiasm And prospects. a to our Well, off Thank you I team's we're good Okay. hope term in share our

expect will patients benefit can a have We significantly number are we in that as portfolio we of more term. line that and medicines grow longer

we diseases of which of number we branded of have We portfolio an be for a most will new and and targeted advancing medicines about, society us. in source facing We're some the prevalent emerging think serious of growth at costly record our biosimilars, pipeline talked a potential new today.

work them meeting a and July. they to you. the to shareholders continue get fully deliver strength second to start Thank thanking business, financial allow our quarter to in us want then and again, I patients. are end investor our the the and and returns staff look will but engaged Our I mission is off Most all our did provide in talking forward and XXXX. innovation cash solid who call meaningful to durable to think, at for of quarter flows also our by thank behind transformational this ASCO invest for We us in evident for you importantly, just the at to

Arvind Sood

Right. everybody. Thanks,

you would to Thanks feel have didn't reach team. you to of you to your me members if out like question any If again. my or follow-on other questions, to get free have discuss, or if comments we

Operator

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

You may now disconnect.

Amgen (AMGN) 30 Apr 192019 Q1 Earnings call transcript