AMGN - Earnings call transcript Q2 2022

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Operator

My name is Jason and I'll be your conference facilitator today for Amgen's Second Quarter of 2022 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr.

Sood, you may now begin.

Arvind Sood

Okay, Jason, thank you. welcome QX and everybody afternoon, to call. our Good we'll jump right to cover and so today Lots in. go

internal strategy of Some the seeking latter our continued and our acquiring announcement navigating key about innovation, this both exemplified of morning by hear today environment. themes through include driven a volume macro and the external ChemoCentryx of you'll lastly growth, difficult

the slides non-GAAP today, posted the for will of financial and in have we use your We will forward-looking. presentation measures our some statements be background,

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

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

Bob Bradway

planned and the XX%. here operating we'll you second driven results, as about. our very acquisition Okay. joining our volume growth which in our second excited with our volumes performance, thank all quarter, of of be Hello, are Starting ChemoCentryx us discussing we call. Today, increasing with quarter unit strong everyone, as delivered for well

innovative sales growth globally. Our double-digit quarter. all the Repatha, and EVENITY, products Otezla, in delivered Prolia well performed

innovative KYPROLIS, record oncology BLINCYTO and in hematology Nplate sales. our portfolio, quarterly all Our generated

needed the This strategic years effects XX which will non-small now spot. Our prescribed the to a is sweet and space Amgen's innovation older products both for life severe medicine, we is are our in off around is of made also the two in start. in this portfolio, LUMAKRAS ChemoCentryx, TAVNEOS, treatments patients TEZSPIRE the LUMAKRAS newest strong XX first cancer more serious short and threatening has side launched a much is and sometimes in and a TAVNEOS TEZSPIRE which product ANCA-associated our to adding period innovative disease. fits cell with acquisition than in with seriousness a the countries vasculitis world. lung right of terrific being the for a of harsh product very of the patients autoimmune given asthma in impact broad U.S. big of another time population for planned disease. a newly With be

Our more been decades add will much would of TAVNEOS value more quickly otherwise and leadership in and us launch, enable than to reaching patients have to nephrology possible. many the immunology

investment. make but You'll innovative Murdo patients this say often. team me in just the from to hear full really for of a working don't can committed moment, we with skilled opportunities highly looking let along difference product. like the that from this forward a We We're that and very to ChemoCentryx potential proceeding realize come think course our an which own Olpasiran attractive through the Dave return X to and the include encouraging and Phase our molecule from for testing. really shareholders the highlights our about of pipeline pipeline cardiovascular data well molecules expect and move innovative biosimilar are for this into and the we will shortly talk

board our the big are growth setting up side, are the Across really role cell us On biosimilars from still oncology from prostate launches. business solid there for where needs unmet bi-specifics molecules that growing BiTEs our these small or several can in to data are cancer like and in the giving advancing diseases the play future us confidence in lung medical cancer. tumors plan of

by you the By to surprise me current that won't debate hear it legislation. Let to the now turn proposed pricing in disappointed Washington. now drug we're

adding will little when and price to reforms less medicines time for our affordability bill for bill access innovation, the controls we've be been improved the more advocating nation it precious improve problem patients. to those bill that proposed bill innovation At result will impose it. innovation. provide a price needs of time, and this respect will to of the of controls The neither. some stymie The For does to

and a innovation is we've of for we for to a time been comes accelerate our those Recent compressed adopted little for however, are affordability, business it patients. some no adapt and world positioning will and trends when accordingly. lose this will legislation surprise lifecycles developments bill So, prices this if and

to not the that world needs the of performed We the patients the oncology and meeting meeting team needs me innovative And we remain it. turn believe the over we of mission. advancing well remain less continue on biosimilar will long-term needs our for serve. the encouraged the broad their Across first portfolio and growth. innovation, prospects globally dedication we of I'm to by Through for patients year, our our of more to and to inflammation, general medicine, let and more now products them a half of focus our grateful Peter. have

Peter Griffith

Bob. ChemoCentryx we're organization The and to enable excited patients. the welcomes help to you, to Thank teams CFO Amgen serve

to We track on our are pleased this objectives. with against and performance deliver we're long-term quarter our

effectively exchange, shown growth We slide interest increasing driven millions three XX,XXX Slide around pressures with foreign We quarter quarter supply results surges. work at percent financial Amgen respectively. Europe financial while before the to globe. chain in of our through and guidance. colleagues successfully sales hard and discussing continue deck. five percent in of growth through will serving mission-driven war revenue the and three grateful growth the rates, foreign I working COVID the navigate product variants second revenue are X and see our and of We're exchange percent the XXXX growth all the our inflation, for one The executed impact product percent patients headwinds, on for excluding second sales volume company the of of present year-over-year results our of

Prime charge our impacted favorably EPS a R&D by the of $X.X XXX% Five QX, six $X.X versus growth billion In-process the in grew XXXX. excluding EPS for It's Non-GAAP XXXX, Prime, expense recast Five Our percent. billion

portfolio. offset six in percent products selling foreign volume sales. Repatha, as Prolia, declines of was the of Year-over-year price well by two was and number product exchange growth of in LUMAKRAS partially to and of Turning volume a net XX% Strong driven headwinds EVENITY, percent. growth as other by

internal operating product biosimilars, cash the prescribed today. excited strong flows established product to portfolio our longer expenses by Europe from to Prime QX accordance one to launch innovation, Transitioning year-over-year, we I billion adalimumab lower deal the updated preparing such antibody January biosimilar year-over-year, continues deliver dollars like guidance billion and our we've XXXX. fund from and revenues ChemoCentryx Our million just decreased generated this related versus U.S. external the XXXX. and this XXXX expenses almost our decreased most primarily that to COVID-XX results QX, of by issued that driven in and Non-GAAP the XX% in Five our non-GAAP revenues mentioned. product Recall previously about discussion no of AMGEVITA the for in $X.X primarily in are $XXX with SEC remains non-GAAP Other sales by of driven policy exclude expense year. collaboration

expenses For two our non-GAAP XXXX items include comparison purposes, previously will excluded. operating now that were

recorded AMG payment R&D First, rights the QX, next, In-Process in to secondly, in XXXX. Kyowa billion Prime XXXX, an And related recorded in next with to QX, Five license $X.X Kirin XXX Corporation secondly to from upfront and associated in million Acquired R&D $XXX

in R&D, simplification investments non-GAAP to support and expenses Excluding than decreased and spend on antibody to a and $X.X product of cost primarily in percent to XX.X%, shipments the direct improvement COVID-XX and manufacturing impact total support, Non-GAAP charge pipeline. second five which due the sales two points our lower due primarily offset year-over-year. operating billion higher R&D decreased declined year-over-year product year-over-year, offset product 'XX, early non-GAAP two second sales digitalization, research automation, by spend percent more Five percent in-process as evolving percent product quarter continuous lower Non-GAAP advance SG&A marketed driven declined quarter in by the the Prime process in basis pipeline QX, launches expenses to offset quarter second percentage reflecting of on costs, by partially a basis partially a of X.X year-over-year, mix.

key expense by of and other the accounting. a expenses to was expense a net while Non-GAAP share income activities method QX. $XXX result productivity. This driven use investments driving on results prioritizing continue as our our BeiGene of We interest in million of and and of were equity net focus

financial sheet, significant opportunities. have to We strong generates retain a execute development flexibility business cash strategic significant and flow balance

execute We capital our to continue priorities. allocation on

the internal or of whether ChemoCentryx best is announcement external. acquisition today's of great First, a innovation, the in example investing of

investing in in for construction Second, capital business expenditures and Ohio our including through facilities friendly our new under Carolina. North environmentally

quarter, Third, $X.X growing while to capital representing a $X.XX share including through opportunistic billion. no And year's from the repurchases XXXX and second the fourth, quarter, in increase quarter. in XX% buybacks QX, share we last a returning had share per at dividends, shareholders

the business for Let's turn to for the XXXX. outlook

we and of with continue growth the be our our through progress We brands. half are first confident the XXXX of in trajectories to pleased

to our headwinds to on expect foreign the absorb dynamics, first the $XXX $XX.X exchange For against challenging now to revenue range full are exchange $XXX year, which of recent today foreign absorb reflecting XXXX foreign the we rates, half million we our the in million product in execution effective of billion. while based $XX.X considering year, sales exchange guidance we narrowing billion

foreign $XX Of year. exchange experienced the to based $X.XX percent on half the in range full that encompasses approximately the foreign we of exchange This or remains $X.XX of $X.XX for EPS rates. range headwinds non-GAAP Our recent of unchanged. $XX year approximately three first

EPS against the So $X.XX half additional in year. of foreign headwinds second exchange we anticipate the an in

both of exchange range to on non-GAAP impact ChemoCentryx acquisition QX. share and with will also remainder to and EPS influence likely additional range. XXXX a trends QX encompasses within a cost are I'll our few with our for particular these of the points focus foreign Our consider how the associated ChemoCentryx, performance

a we in of $XX product are QX scale most with exchange year. in ex-U.S. half AMGEVITA, million XGEVA. a Aranesp, total expect such for $XXX These as QX the and against each headwinds sales Vectibix pronounced in foreign second of headwinds First, Prolia, million of and quarter for significant the brands approximately

year trends pricing declines negative the expect continue of the for quarter of over products in year. anticipated we sales expected and half second to product KANJINTI and quarter for remainder those the Second, MVASI the in are

We the $XXX roughly roughly sales for year of the MVASI of million. sales $XXX million and expect year KANJINTI for

Amgevita we've and Biosimilar, with look forward in As Biosimilars to we United be products geographies of States noted, in the January, launch will the driven and growth the XXXX. to new addition by the HUMIRA being in first

sales sales billion expect This billion. QX billion. the full $X.X to to Fourth, now change to $X.X year, a of QX expect Neulasta from for previous billion be product Enbrel range we approximate is to product we $X.X Enbrel sales. Third, between $X.X product our

at unchanged in year. Neulasta to $XX result will $XX. remains factors reiterate than expect $X.X in We we expect to a the QX. the guidance of range expect We pricing full range lower to will would negative that second revenues the of our our that QX trends XXXX continue half EPS these prior impact for revenue in although versus Fifth, for billion. of I net billion $X.X be now to year EPS other of $X.X $X.X and

total for time operating unchanged non-GAAP from the expectations for we Our XXXX last expenses spoke. are

the will the current including and upcoming our the of that versus year, expenses of We R&D the 'XX spend investments expect third operating important January, increase pipeline continue as year launches. to well Again in half in in in first and second this increasing Amgevita quarter. both fourth half and including the as

non-GAAP to XX%. product operating of sales XXXX a margin expect to continue percent as roughly be We

expect of product be to a percent We continue cost of to non-GAAP XX.X% sales sales to XX.X%. as

our in R&D of AMG recast $XXX with on XXXX QX, for the Based Our XXXX related license non-GAAP to results in include million XXX. which remain for KKC expectations expense now unchanged.

Our a expected now R&D to of year-over-year. XX% expense XXXX equates decrease non-GAAP

down product of expect year-over-year spend as non-GAAP a SG&A to sales. percent to slightly be We flat

first to We our increasing the rate the and continue and And an guidance BeiGene's XX.X%, of to other billion anticipate of to XX.X% to a rate the we share expect be up two year, $X.X non-GAAP due in expenses increase our run for of XX.X%. range prior rates, of from interest finally, QX results. to both tax the full $X.X XX.X% quarters in of to income with range over

and throughout turn update. the continue Tezspire over successfully pipeline, of in best investing and remainder launch the ChemoCentryx headwinds Lumakras I'll despite Murdo? concludes of on We our the We will our in innovation. XXXX the continuing This to driving integrating Amgevita we will delivering of progressing it to January, effectively execute the XXXX, financial look objectives. the 'XX the Murdo. launch forward

Murdo Gordon

Peter. Thanks,

driven year-over-year volume percent three increased sales product quarter Second a increase. XX% by

LUMAKRAS. several Excluding product Repatha grew delivered KYPROLIS, the additional double-digit impact percent, we for five and including and products Prolia, quarterly growth BLINCYTO of for sales record foreign exchange, volume EVENITY, sales and global delivered Nplate AMGEVITA,

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

therapy vasculitis, the strong inflammation with to portfolio grew by I as EVENITY, autoimmune XX% XX% with comment volume General acquire price which grew on record prescribed and and and million personally and severe In XX%, sales percent about opportunity help due Repatha addition health, year-over-year start TAVNEOS the disease. In its the sales Overall Enbrel Aimovig. driven quarter, performance outside both second announcement driven sales more Medicine volume efficacy driven and grew portfolio. long serious for patients. of and also declines quarter, our this by business, our active repeat a ChemoCentryx EVENITY record second XX% ANCA-associated new selling in includes year-over-year. track our for in say I'll the to to remains quarter, by the XX% U.S. an primarily increase the growth to for by I'm growth. had I'll volume U.S. frequently $XXX about revenue XX% driven life-threatening of net of patients excited of potentially volume. bone in Volumes a year-over-year Prolia, a safety. the eight Prolia Enbrel decreased growth and

Tezspire treated a asthma. with start a Tezspire biologic see Our broad We're I'm million patients in pulmonologists in $XX across prescribed strong of both off previously quarter. also very both is range second and sales and in launch initiation uncontrolled have of with that to encouraged seeing severe naive patients. allergists the to

eligible coding final a we as permanent million and July to differentiated worldwide phenotypic is potential for profile and acknowledge severe which limitation. benefit received asthma Tezspire biomarker or product who are Physicians X. reimbursement treat biologic patients front, unique access without of its broad Tezspire's the the On X.X any with medical uncontrolled

Now, or TAVNEOS, inflammation opportunity a brings Vasculitis with our AAV. treatment agreement and nephrology for leading by into portfolio recently to our launched first-in-class acquire compelling ANCA-associated a ChemoCentryx

a minute disease can for small and inflammation of be autoimmune patients. me to AAV destruction Let important serious I process This how take inflammatory about to that vessels. leads a to eventual is talk will TAVNEOS think systemic blood and develop lead the organ significant U.S. severe the or eight XX,XXX life active in major a cases options of relapses a disease represents threatening. damage for AAV. treatment who can experience permanent advance TAVNEOS some to severe be in patients year

we ChemoCentryx by and and TAVNEOS. working forward the deep with team substantial and that presence, experience patients I'm with with Amgen's and can looking are more confident meeting talented inflammation at nephrology help We to applying AAV many in market

Moving to our hematology and oncology business.

strong year-over-year Our we XGEVA year-over-year six driven and XX% in was with two year. QX and this growth flat growth. volume which declined innovative volume by to products throughout was percent KYPROLIS, BLINCYTO grew volume QX. continue XX% for Nplate in This expect

biosimilars where non-small over prescribed in status second LUMAKRAS of therapy XX% first-line by able progressing U.S., $XX when launch setting is progresses only are support when second known patients tested decisions the that inviting we're quarter, line and Unfortunately, growth. XXXX over removing In KRAS LUMAKRAS test receive is shares. Outside year-over-year, actively status our physicians, XX% representing quarter-over-quarter treated. are for lung KRAS XX% the community have in rapidly well the broad their our oncologists XX% review revenues patients of cancer do Sales the remaining has in XX majority for reimbursement time while KRAS the hold while both GXXC with the in the launching and our to oncologist second-line LUMAKRAS the patients and markets Biosimilars of been the these approved of beyond Our countries XX cell adoption GXXC and to countries. of leading the the that in KANJINTI status, declined seen seen U.S. is teams the LUMAKRAS. available setting, has U.S., over patient results XX% oncology been ensure million are we've to of X,XXX of to barriers treatment in and pursuing in now we've GXXC patients

industry-leading billion has competition. which We price declines franchise, volume our sales and portfolio driven $X.X continued net selling contributed become by cumulatively. has In an expect Biosimilars deterioration product of total, increased

AMGEVITA forward, January in execution pleased STELARA, launch SOLIRIS. very the next excited and of wave to Looking the United followed volume Overall, growth EYLEA and in with the by about in we're upcoming XXXX, of Biosimilar States of I'm our the quarter. launches

over strategy. Our expanding exciting diverse international it to And I'll position turn the addition to on us and presence Dave. portfolio long-term products, that, of growth of including our TAVNEOS well deliver with

David Reese

Murdo. I'd afternoon, for to Thanks Good announced everyone. we today. transaction start by the excitement my like sharing

patients disorder. heard unmet the appreciate ChemoCentryx. ANCA-associated addressing benefits the to threatening As need. the Having the life face of a forward I and look at serious and they these treated working team in vasculitis sometimes I personally, fully with challenges TAVNEOS you've is significant

also in research in the reducing in where of For programs approved data adults one in in Beginning Use our for and Union study, Canada. for new evaluating severe Phase dermatitis X The TEZSPIRE with moderate Committee corticosteroid of inflammation, was ROCKET program execution Phase the innovative was European designed the initiated patients approval for and with monoclonal antibody, the We development, safety continued assess oral in was initiated second in efficacy and innovative pipeline. severe to use asthma. TEZSPIRE June. recommended rocatinlimab, Products asthma quarter continued we robust the dependent by corticosteroid and an atopic to oral announced July to SUNRISE X anti-OXXX Human Medicinal clinical with on progress, for several

efficacy or issues are with the partner, to convenience No of improve a investigate patient our we have and regulators and additional studies safety Following further discussions doses. amending range arisen.

our program World Conference on In oncology, will we upcoming excited Lung programs about at potential data the to of broad We of in remain dermatitis. Cancer. this from two present the thoracic continue atopic very

studies. is cell HLE The this tarlatamab DLLX first studied being BiTE setting demonstrated small heavily the few with options. treatment patients lung with cancer, in tarlatamab, In molecule antitumor targeting activity population in also inhibitor with a or Phase setting. AMG the X. pretreated lung forward to inhibitor look Conference a cancer lung cancer. present to data cell in an patients cell are LUMAKRAS this in embargoed checkpoint in first-line our a We're with August durability. small response former in with combination and until in of potentially with enroll registrational prostate combination and continue later set also small updated cancer PD-X neuroendocrine second from X line XXX, standard I'll SHIPX in in World notable tarlatamab We presenting investigating data the in trial patients care combination from Data promising

the due today, the can issues. we to agents discuss is but to PD-X been results other with challenging So targeted can't say we combined have tolerability

will dataset a comprehensive this We from present study.

expressers PD-LX Phase a planning reminder, non-small expression potential pass are are based LUMAKRAS the multiple line treatment cell first-line seen promising population first negative to we cell discussions study initiate a non-small PD-LX lung levels segmented in breaks and early into PD-LX down and negative X cancer. We've the cell with we As to high regulators, chemotherapy metastatic potentially investigating advanced in where low data on by thirds expressers, or expression. with roughly LUMAKRAS cancer lung non-small cancer PD-LX lung population of plus across of

significant are excited polypeptide to and In completed and patients activates of Olpasiran, a to enrollment. of week outcome XX is receptor, study. up levels X XXX, Vectibix all concerns. full demonstrated general with received multispecific to completed. greater data gastric with and at data cancer, safety gastrointestinal four RNA Phase from the In reduction are announced response colorectal in in (GLP-X) FIGHT we and at innovative dosing FOLFOXX interfering Revolution the combination outcome study Presentation expansion the plus a refractory in majority initiate FGFRXb very results prior inhibitory both a These the of pleased highest fibroblast Phase from were the line primary KRAS lung safety from XXXX. the confirmed had range medical modified junction molecule X We're of randomized, in controlled treatment patients XX, partial Bemarituzumab, gastric AMG results continue Medical Society No Xb non-small frequency. in the congress clinical dataset, peptide we announce half greater KRAS who RMC Phase cancer mutated a place study cell of a presentation also has A that demonstrate Lp(a). FGFRXb cancer final Medicines very Phase modified FOLFOXX European efficacy inhibitor The were LUMAKRAS inhibitor of disease While rapidly tumors a our by accepted about study doses, of dose evaluating increasing for these X the Congress of cancer data expressing In once which every double-blind, analysis combination LUMAKRAS identified with a during advanced treatment, Lp(a) this was patients XX taking second concerns period at in every survival doses this combination weeks new patients GXXC untreated with without or X gastroesophageal Xb to of expression. three and of year. monoclonal trial September. for factor at with we previously small RMC of the with the weeks glucagon-like (GIPR) was two observed control. for benefit end improves baseline once with with expected Bemarituzumab endpoint antibody from receptor no the top XXXX targeting that to smaller growth Medicine, four the period. at new inhibits than These in GXXC the moving encouraged safety are SHIPX and XX this XX% and of receptor week targeting LUMAKRAS in the of a treatment Oncology FGFRXb

clinical to programs submit portfolio, program conclusion, an a In we're are continue and have back to Phase important X the patients a answers. Bob to to of first-in-class and data for term. approximately medical innovative are for potential positioned our Biosimilars, We growth are this this with actively well year shareholders the X molecule. deliver that, and Phase three congress for with I'll late planning growing initial quarters portfolio study the this stage to from cohorts And for occurring medicines and near of it we of turn and long new over questions

Bob Bradway

you, Thank the asking could callers Jason, process Okay. Dave. for question? a our you remind of

Operator

[Operator with Instructions] Our question Olson first Jay comes from Oppenheimer.

line now is Your open.

Jay Olson

deal, congrats your Thanks for question just revenue the ChemoCentryx talk in Thank taking within on unmet a and it looks fit you. synergies, about high like the with exciting synergy particular really the you and medical ChemoCentryx strategic AAV. opportunity to Can for patients treat organization? in our the need then potential,

Bob Bradway

you as We, Jay. the fit. we're tell Thanks, excited about Yes. can

We help see expect this opportunities even be reach so and teams we very and and Amgen opportunity, good think inflammation growing terms excited inside fit, have investing of ChemoCentryx more product to synergies, to implant obviously, added nephrology some and this and far. we're it's have team patients the a we focused our in will on at but they

have think our patients about makes great don't otherwise an will important them. on it it so and reiterating we in a because who that the more really at to this to don't much that other focus alternatives we're available for excited need difference So have I be addresses big point than marketplace, say

Operator

comes Our with Raymond Sandler. Piper Chris next from question

Your line open. is now

Chris Raymond

Bob, drug it comments the digging as I the maybe in Thanks touch maybe another also pricing legislation on can to on and very relates if TAVNEOS this much, also your deal. on question just

guys a having intend to guys nephrology you point inflam the in role. color think unique in of these is how maybe leverage presence I bit more forces you a So specific and two side, you the for just out commercial give kind

maybe to and and Thanks. provisions will. issues decent then allowing of is maybe there the So there, molecule nine targeting those small so square specifically and two just part a you second a you're ChemoCentryx is small negotiate pricing language company, if molecules drug predominantly of CMS have angst this amount around

Bob Bradway

question. on start to first wanted Murdo the

Murdo Gordon

question the Chris. for Thanks

there AAV the of with team pleased our obviously treat fit strategic very of portfolio. rheumatology rheumatologists are on in mostly are of these The We nice have TAVNEOS lot who sub-specialties and focused a been ChemoCentryx's patients.

can they've inflammation so footprint commercial we our have national been efforts can given that business in-line far, rheumatology much more third AAV up is inflammation, of or on patients broadly, nephrologist a that renal in renal and about quite a of also I a their by focused these we we current add So, should scale given nephrology, impairment the presentations one say. diagnosed end getting

the also benefit, resources institutional work support to policies that's and our authorizations our So and account immediate patient that to in ensure got payers seamless like providers we've medical with key patients. medical but our teams, ability our managers programing, prior are for

far just is we a lot but focused, bring beyond can effort. to there So, so the very effective table very ChemoCentryx a

Bob Bradway

Senate at to as moment well potential making its marketplace the way legislation is for product to small Chris, an and with think the small legislation the other of molecules in the profile risk in respect that product, And legislation, the pluses clinical to and well, or to excited out, with particular compared molecule product, be again, this the joining looks there's suited needs really controls subject is to as we the Washington, become this obviously that implied so we the this through this any you expect we could attractive evaluated we're the a the context them. point the team price of don't that's

Operator

comes Sachs. question from next Salveen Richter with Our Goldman

Your now line open. is

Salveen Richter

being for if business AMGEVITA about probably into just sense make you said reposition of just would non-orphan the financial to Do like dig a urgency payer Thank an and here. prepared targets M&A, a discussions on give a of for question Maybe lifecycles. follow-up you the trend orphan you the can deeper the so, here. that second of here products strength sense versus first what maybe products my and and what us manage the afternoon. and market, in think little given about types debate a I'd you. remarks early you to how just increases Good positions taking this question. Thanks passage this given to your legislation, accelerating

Bob Bradway

which Salveen. the I'll Yes, first address of you again the with Washington catch will piece respect Murdo and that is to second

As you know, this is still legislation. potential

carefully gets we'll So exactly it what see passed. goes gets it if if watch passed to and

think we'll things. that that access don't more improve remarks, I I extent in would the at of said concerned what So, this to which my those we've for say advocating patient doesn't the two point, reform to will do and it specific legislation innovation promote anything and passes is opening been be than

Murdo Gordon

Obviously, that to U.S. but feel we're U.S. first AMGEVITA, on obviously members given that out option. the reimbursement and is U.S. leadership for availability interested share in in pleased year, outside and structure, able market the at January AMGEVITA and higher established our next where launch market a have payer we and ensuring we've biosimilar we've Salveen that at AMGEVITA despite early launch PBMs the the AMGEVITA coverage we're hold that the end be in to we establish access we'll able we confident been competition. patients pleased And are their market the performance different the think lifecycle the and good of and were of with with with in payers gate

well going according all and to plan. So, Thanks.

Operator

Evercore ISI. from comes question Umer next with Our Raffat

Your line is now open.

Umer Raffat

Maybe about lack if two ask as saw OXXX quarter. the your I'll on and press the well quarterly I the the starting program. your I issue your today, safety one deal release of on as guys, may, with one on Hi partner talked update,

there a two perhaps using And deal. be that, question dose no prompting issues to guess you Phase the were weeks assume X. if you in to a in ChemoCentryx severe it drop need my is every feedback. this us regimen. the TH is biomarker on then safety change currently fair is patients, subset dosing if is, of could I a maybe change And which there remind could regulatory However, what

it's very now but Thank I think an the assume to of were already their the forward the has good with study was interesting wouldn't they plus where sort unless how you by have patient perhaps XXX peak data that you guidance receptivity patients commercial X,XXX. yet stood and is moved versus fair case it clinical much. deal, on been,

Bob Bradway

first. the take to want you do Dave, Okay.

David Reese

to regards patient kind no safety no In subset. yes, no Umer. change issue thanks any of biomarker in OXXX, issue, Yes, either,

by anything beginning explore range I remarks doses and or I than patient said and to took think that prepared with timelines. don't we the it read more think we opportunity wouldn't overthink that ongoing into will my we As of convenience. really to this FDA this discussions it overall program is in improve driven broader affect that

Bob Bradway

looking I'm in. for Murdo your specific in but sure feel free you're jump not what to exactly question,

Murdo Gordon

organ have you I tolerate base Yes, standards treated this for you here a if treatments is lungs, relapse-free are to can to not and is skin or I we've add the TAVNEOS TAVNEOS their do current remain care and inflammation journey a and and that. all and if cause difficult this intervene patients nature for everybody over of improve first regimen, disease. and and efficiently kidneys, XX a the patients a think do quickly acute of following end to the autoimmune severe to organs nephrologist, the you you're Umer, can involves weeks damage the remember while permanent the that going that to mean been has other to if effectively sometimes what is rheumatologist potential and that as

to here of that's and the choosing encouraging one glucocorticoid think So launch. that early it the change do potentially reducing behavioral I potential see like standard the is as in But physicians you TAVNEOS this relapse are alluded patients to of we reduce reason the care for by the phase that TAVNEOS helps and been current many is use. to, adding to

if and our fit own inflammation in, into comes squarely portfolio it's us a and already we a development think one is it good in to what and that our it has a disease area capabilities on the strategy launch. would our that allow this strong commercial were we doing accelerate scale medical been so So will and

Bob Bradway

the attractive say we feedback that add the that been that of The and marketplace the and and can we still an launch. is. at Umer I'd has marketplace, based value is its encouraging. patient fact from stage prescriber early are to We obviously think

move on. let's Okay,

question? Next

Operator

The Yee Michael next Jefferies. with question comes from

now is open. line Your

Michael Yee

Thanks combination maybe the now about you've for challenge upcoming data David. the with the in question, for know I PD-X. talked

line into there could talks. really expectations with chemo. the forward front bar size to you high on your to due the fairly right is focus just is move maybe And combination your So

when in talk I obviously to you a lot on So maybe forward. second, focus supposed you sneak and there there's could XXX just there of make deck, just a slide just that advancing actually Thank we're a AMG you comment your about Can you. know if obesity. know in on comment what

David Reese

sure. Yes,

the of PD-X of I Sunday terms in can't data because we're say these afternoon combination, much Lumakras embargo Vienna. in presenting obviously So

first-line low expressers. whose about are intermediate think of PD-LX I'd in negative, of of those high that who think those to three those PD-LX development kind are we patients are like tumors PD-LX and are buckets As to

to that particular enrollment congress like the the about in based progress very have plans we're tumor will submitting PD-LX we PD-LX where in groups more there medical picked further data X over with a to say As as results a On are that's and in to coming but I this Vienna hope AMG look trial the the as patients planning X. moving the now, you in checkpoint of finalized on can think chemotherapy our probably that program as right what X say mentioned, very space, we plus and expression. on with mentioned think plans disclose and actively our therapy I are Phase as process up We forward that completed our population, about for in months. I I the of and we'll inhibitor to Phase we're Lumakras present in the negative Phase we XXX, then outline and submitting, of all different really their will this tailored pleased will development I be would the

Michael Yee

Thank you.

Operator

comes Our Harrison Morgan from Stanley. next Matthew with question

now is line Your open.

Matthew Harrison

Great. think How Good you the you'd of deals and to about over We terms where bit to that course year. think transformational a more afternoon are on just like do adding your about larger last just and of the be? do and size in modestly continuing outlook thanks something due M&A. assets to If of for sort of assets sized versus and you I of could a do where versus question. deals how you taking the pipeline see more with BD for Bob, ask

Bob Bradway

the continue advance Matt, invest trying in I to try for in focus and on stated and is don't our look think to we business ways anything has find particularly we've changed, areas to about interest. to clear where our been the the best innovation to

general So the area. medicine implant then oncology and

small that. add continue there in all and are and more size we So the consistently many obviously our Matt, for feel look options shareholders to are value medium said the in large through we and we'll tenure look, to opportunities responsibility continue as there the do But to size. I've my at to

Arvind Sood

Jason, next question?

Operator

David Risinger Securities. comes question next Our SVB from with

line is now open. Your

David Risinger

Yes, thanks much. very

two interchangeable question please. my to is related So understanding and parts, Biosimilars there are

though days conducted. was hit part won't have study in that obviously Biosimilar Lucentis product's AMGEVITA never first, of a of since in talk of is just that FDA AMGEVITA switching ability with second approved other great news interchangeable So a ago first interchangeable that about position a the the are even there half you 'XX then half couple compete is year, the as but And next designation. that could to in the launching Biosimilars

that ABP as I'm also to is approved So, you. XXX be your or sign interchangeable. a if likely Thank wondering that's an Biosimilar EYLEA

Arvind Sood

our interchangeability an an and a insurers that them Thanks, barrier and as has to innovator. have for option consider payers would AMGEVITA question. and matter, the say the with alternative physicians conversations David for I right to now been not in

with interchangeability we'll the and pursuing to are those readout in expect data launch. We later AMGEVITA on

launch we'll our think they with a quickly our I as interchangeability additional least own enter they whether being our will So if have help first at follow incumbent expectation is data. but and to position competition interchangeability couple will

be where short the exist will that time persist it advantage may period or competitive So, in in a market.

XXX, speculate FDA Thank you. on As the won't I for might about what say that. ABP

Operator

from comes Wells Fargo. question next Our Mohit with Bansal

is now line open. Your

Mohit Bansal

for thanks study. LUMAKRAS question Great, my on taking question X Phase a maybe and

could think than So, think placebo in you. tends clinically think response trial? be Dave, do what be And question in other part chemo about the historical forward Do well. to you you a docetaxel could basically of this better particular post-IO is this study. chemo if the Thank you do benefit meaningful particular

David Reese

The In progression-free terms cancer, really the well event advanced X the consistent we've see will difference significant report Phase has program to trial lung behavior think there. trial, we detect XX% we date observed this track quarter, of a on of I to what power if in with driven it's an across LUMAKRAS study in be to survival. out positioned

having conducted So, so will look powered, those to well very study it's I'm sure be well we a soon. forward and data it

that. as be of to hard In a that we The of what response, additive the placebo terms plus negatives in checkpoint are on benefit. addition the chemotherapy think conducting therapy a LUMAKRAS it's the has speculate inhibitors that I standard would modest arm considered trial PD-LX where against relatively

with chemotherapy in regulators on what's given confidence had we've productive at move the based as about that us seen, that into we've design. to looking data discussions and X LUMAKRAS combination So, Phase preliminary with trial

Operator

Bank Our with from America. Geoff of next Meacham question comes

Geoff Meacham

getting I you reaching the are for with Thank at X maybe us say the, kind of in would high to opportunity the level do envision you the lot to have or the if three but as just about over that I quarters same LUMAKRAS, help you timing How maybe a, you and Murdo look Commercially, outside the maybe, study for saturation then on GXXC you. guess of one kind is level Thanks of people look that the Phase trends combo you. of at you question. U.S. of for terms studies, incremental so that data. U.S. much combination a asked had of when sort testing? so, think the kind peak an there past of about

Murdo Gordon

where already XX% less tested what Geoff. we've I about receiving progressing. population frontline tested know line result it's thanks got available of patients of KRAS we the test in GXXC peak half a now the about is would Right say in has second the for U.S. status. only patient and they're question, Yes, when the testing being

is so patients XX% LUMAKRAS. that those we're progressing on give have the that that what treating that test of the are LUMAKRAS for of get half the result is benefit when oncologist that time, So we they and where again really patient test on, patients that's can focused focused

second penetration getting a we're the patients of when their physician line those knows prescribing So high very test results. percentage

we more improvement patients half their for GXXC test got KRAS progression. currently of not are yet. are about there, So, not upon headroom We've getting reviewed picking those result

U.S., the well and and can what an very developed well Germany, outside quite U.K., their available developed, again that's focused the Spain, and lift revenue drive the clinical places growth thing information in a retrievable I testing types that seems very think where tale that's in markets markets we more what do what systems So second developed very the extent, of France also to on. are are biomarker like so where We're Switzerland we've progression U.S. seen we two line. not uptake is seeing U.S., and is rapid continue as seeing is resembles upon and think it Italy, uptake that test well to really in to important in That's the in of some we're some

Geoff Meacham

expanded our And programs? access just clarify. This is in

Murdo Gordon

of we've clinical therapies, because you that a utilization, you're but expanded other experience with I'm slower where some in access programs also others markets going other targeted uptake will see about our testing to talking seen in In infrastructure. than

X, and is promote the and clinicians. working we're to LUMAKRAS. with an changing course, because markets, on grow the Phase get this accelerated with second value makes behavior And datacenter of that approval and compelling to we'll hopefully of product to what does that I successfully in it it those no reinforce continue line data we're in longer easier be that we we're on So, able if think confirmatory

Bob Bradway

Jason, next question?

Operator

with Yaron question Cowen. next comes Werber The from

Your now line is open.

Yaron Werber

and drug for data severe bit was that David, mixed. a you and it's Great, thanks in Tavneos, taking glomerulopathy suppurativa was my respect tested to the with question. for HS also hidradenitis CX

they Nephritis CXG looking that thinking I you. well that supportive indications of. feedback they're is study another FDA were were Lupus and about thoughts think these are starting and as for you you Thank and potentially

David Reese

Hi. Yes. Yaron. thanks,

as of limb other in which hidradenitis again you're all process suppurativa, address Look are may of investigated as new role those effective ChemoCentryx there currently where CX in inflammatory what a the glomerulopathy best activation the indicating potentially been where play very of Tavneos So this disorders and has cascade forward complement little disease colleagues we'll at such programs there's and determine data. diseases from with the to at therapy. our is look path the

Next question?

Operator

Gould Carter question next comes with Barclays. Our from

now Your line is open.

Carter Gould

Good and thanks taking for afternoon Great. the question.

the to wanted and about you. myeloma forward. discontinuation the had to that I have franchise. multi-year I a hemog the had priorities of what more going you BLINCYTO myeloma, franchise, in does of Thank in compete you sort saw and jumps does of where Is So, rank KYPROLIS come terms that Amgen still to it just your broadly say latest guess still speaking required but of innovation effort hemog try to we to the bite extend in kind its

Bob Bradway

in parts. this take to going We're two

competition also very ahead raised or with think that. see BLINCYTO space market you obviously I you generally to myeloma do performance a hemog think referred an important talk the lot portfolios, think point, encouraged with our very again ALL. to that XXX had do we ability to And we respect and the with is by respect a continue the ongoing decision patients But can which we're encouraged to is in I multiple get relapsed-refractory crowded our successful to and of to about not. to what KYPROLIS more we for the what of we're by ongoing

other So, myeloma want in prioritizing be medicines where best-in-class and programs -- we you multiple useful Dave, may to those have think on we that underway and and we first-in-class be we're can

David Reese

Yes.

XXX a prioritization extremely got substantial example you'll see area science the on so lead. AMG that's for an kind AMG chose a tarlatamab strategic what we DLLX program our we're was uncover guided and BCMA multiple molecule where we and active, platform focus think XXX of this we've forward. look biology that by efforts targeting to same As I the agents that got is going and We've

Arvind Sood

Next question?

Operator

Evan Our with next comes from question BMO. Seigerman

is line open. now Your

Evan Seigerman

we've cancer walk my T think I just earlier around cell given the today, your me bispecific to just the prioritizing efforts. for through touch do much details here? BiTE XX of targeting prostate some your you affinity lower that may taking Thank Thank so remain question do want this technologies deal PSMA, you XXX actually you and the on in newer on congrats recent the be seen efforts for can CD you. data and competitive you how space Can

Bob Bradway

question. the for Thanks

generating quite you three where targeting of is include DLLX it's, neuroendocrine we're targeting elected in hope this then, speed which we Acapatamab XXX AMG frequent seen in came and prioritize some a to next trial are targeting or year from to prostate the that data PSMA AMG the be got is share to you're The few we look cancer program. one at first now from to, Tarlatamab study a and that year pair continue first in data similar to acquisition study into So advance if from we accumulating alluding in data deliberate with a handful all late with days through molecules we impressed be we've in things AMG on patients take conducting forward. that phases. what dose We tumors. in us XXX as human indicated, are we've based moving ago XXX where I to AMG neuroendocrine we and prostate a sometime going expression of early steep saw, data XXX either ahead escalation I the to actually able the along But and had would a cancer, Teneobio all

prolonged especially you what regards more particular for think and and I'm XXX example. on up, I disease seeing follow in that patients with AMG in the need is in what this encouraged quite from

is medicines feel may to in three I on cancer. do of very prostate portfolio advancing be able we optimistic that So what about actually

Operator

Our with next Guggenheim. Michael question Schmidt from comes

is open. line Your now

Michael Schmidt

one I taking for my Thanks questions. had on Aimovig.

Just you decline, trends? given just do is a we could of doesn't run to peak competitive market about have or given function should dynamics XX% how that if and volume those think here wondering with dynamics Thank you. potential pricing

Arvind Sood

Michael. question, the for Thanks

we that also we've provide population reasonable patient at population But patient at we're a to in affected volume focus been able access, good address evolution. price Aimovig where major the we our to pricing our year improve into the year a think one able in to we've and been in way well, been do year-on-year. that's but one sure think lose that end has net and I making did which PBM I strategically, we be of last that on this

profitability So standpoint doing from a better. Aimovig is

and should early marketplace I it antibodies the think it's the the is term, older of much, CGRP and than what's that be the class in growing longer faster than available much in non are class market CGRP well so the and continue better given orals, to have we days. for it's high play on course early focus patients of there. We're frequency the promoting the watching got preventive do continue we've still out, advent migraine we it to that

see. term, I just a there's wait So think to longer lot and

Arvind Sood

question? Next

Operator

Robyn Our next Karnauskas question Truist. comes with from

Robyn Karnauskas

Great.

I platform. question one had follow-up a on the I think Just you. and question

of deprioritize the companies put -- could should the because on BiTE topicals money and at put bispec seeing I do need they so and you I general, some well, price lower more the the next drugs new point given to out on data, think on that what BiTE follow-up data pricing new at thoughts are BiTE the the the And to some pricing Evan's pressure. but then what your are Thanks. and about, board mean, bit little how that say, a talk just there as -- from we over from just like coming OTEZLA, approved for in that spec those going other things? point two volume So new across you the versus, you or about new drugs, year Regeneron out know toward September, in to the question, platform at other

Arvind Sood

So with affecting into is thanks for question, market Robyn. question entry the our I'll on how the Otezla with business. the topical start the

and our value is current more without for we've to PBMs, adding and pleased payers Otezla. rate population any I contracted so with removing able didn't expansion more our seen the in were patients encouraged in our and plans those with to include by our to we the coverage I is rebate that with myeloma label the conversations that prior to authorization fact, payers, increase the included mild what have own deals we think been have PBMs what am in expansion we've have population patient label of really include patient our are and to requests overall

the on already we competing a try to net not are and topical we're involvement, location price systemic have factors entrants term, in The I seeing provide that think, the think price is in payer is quite say the pay to until So, types in access area in access talk the because don't of that be a I bit on fall it, to we and patients deterioration I a of Longer the play, come end the treatment for coverage do a U.S. decided of their systemic those though patient overall, have co-pay a so are really net and affordability. see that they where is think our really is willing for they race the broad into to improving categories people entrants. what topical rate our their continue competition these into treat challenge the stay you'll if that coverage without they into well the because to whether are What happens, complementary will where I'd body it on and we Otezla to Otezla see the it. many is we want to where pressure price having topical That's we remains on surface with net direct pay patients you pressure as continued assistance or who want psoriasis, yet a agent. that the, dynamic move topicals to in dermatologists, that's seen on don't

most So I see non-overlapping are populations part, and pressure. topicals we is applying the pricing necessarily think don't with they're for

David Reese

that generation a or pipe is to some things, efficacy, the will In do two engineered tissue-targeting regards things that here try increase been into with we've Robyn. where technologies enhance targets as activation, and to an is so the working have Thanks, little therapeutic goal new is gates incorporate window and for either gate platform, from agents. for possible on multiple an time gate the real BiTE logic AND or two normal one, the you the like

to get towards So as launch. about to first molecules say we are moving clinic, and have more we'll ready that the

Bob Bradway

hour, bit more the top got we've little we're know, past the but I Jason, a questions a of couple Okay. in the queue.

more take for we then don't team why you and will go around get Arvind Could receiving next for So a the couple call? his some if and we I don't be time. to just

Operator

Our James. next Dane Raymond question from is Leone with

Your now open. line is

Dane Leone

here. drug, of the of opportunity focus current I clinical just other for estimating Thank the might drug. you Could schemes might or but Lumakras taking patients LUMAKRAS of on you they for paid be the just assistance patients be what eligible that to everyone for not define obviously maybe is your are just would studies real co-pay in a, get or current that questions. on the wanted in understanding U.S. the that a for be where is other study commercial in

be would again, really could that and run as would what helpful the over you. think people what to time the below is obviously Thank the be here just estimates the rate be I peak are trying sales triangulate well in U.S.

Arvind Sood

Yes, Dane.

don't but it the address rate. think clarification, steal I if I please question, clinical trial your don't understand you for ask I that

patients is would the I'd XX% say, the are other of less cancer in If than cell treatment, who trials clinical but line as that that activity physician you that. When drug not That's in test a physician happening in has increase frontline KRAS lung the GXXC that the times gets relatively lung patient. result line. percentage total commercial GXXC cancer major right happens prescribing available that X.X the is enrolled will, estimate as non-small earlier. to of occur, and are are when we second was patient question has our is from second-line challenge in trials clinical the working at estimate, of does XX% are depending vary and I LUMAKRAS up time the answering an when The and about KRAS the on investigational down gap in a result the does ensuring them the that journey that goes patient second other be treatment is prescribing progressing growing drugs it small and now patient to attend to LUMAKRAS.

for in that just your make administrative we're as So, also patient meet of test of retesting awareness the they just, the treatment liquid second our that we we is the that and biopsy to I and that close down We product know line question. choice. to profile having of second of that to time, at answers and usage patient conducive hope have line. we result same challenges second-line the reassessment driving sure progress

Operator

comes next from with Wolfe Our Tim Research. Anderson question

Your line is now open.

Tim Anderson

you go and up very of HUMIRA maybe to to rebate best with whether and to being the product wondering product. ends constituents in back their that priced Thank Biosimilars Can payers that imperative Amgevita lowest I'm priced the being branded additional sense view simply I much. may enough is offer here our the U.S.,

to what price question, product then it in really. HUMIRA most driver you. Thank the that there Do at are that is used So that factors being important possibilities and of lowest-priced other branded net my up ends prioritize you or play questions the realm products? two be going of agree

Arvind Sood

important pharmacy the that would do confident go-forward it. a I something HUMIRA to go managers focused a transition to It's and our Yes, definitely differentiate the is from insurers, are what that the say we've upstream before where manager benefit price in benefit we as successfully are described basis past is pharmacy on and an be to obviously. driver Net I only think And but can possible. we this that we'll is I've seamless describe in thanks. as able brand to able we make and are one. the been the not as this can biosimilars AMGEVITA

prescribing on have these We call GI to deployed force field that patients. rheumatologists physicians treat and

in programs innovative over and these designed patient have many years. compound, we've are the with that innovative programs also the We we rival compounds marketplace because

understand support the administer help and how patient product to device. have patient their We to use that

world-class manufacturing of benefit with interchangeability we of have in and and progress. mentioned biologics have the that I coming sustainability supply We good really additional

confidence to the transitioning So from the does of actually don't have bad biosimilar. on patients their have and improve to brand PBM want that they payer the a because part experience

biosimilar, even we'll biosimilars Now wait the it the see that Yes, that is Bob, the but out. how comments? market. a closing retains that's of substantial possible possible, share with in brand course and plays

Bob Bradway

Thank of the our our first And that all carrying well. and momentum call. to second the looking and forward represents We about executing joining the the you and we've through of that excited of for year you, well ChemoCentryx the feel half as announcements inflam the and we're year Arvind. into half obviously been again, nephrology franchises that future thank what

joining. look for after We'll forward thanks catching So, quarter. to with third up you the

Arvind Sood

Great, everybody. thanks,

Operator

QX This concludes XXXX our call. earnings

now may You disconnect.

Amgen (AMGN) 5 Aug 222022 Q2 Earnings call transcript