Amgen (AMGN) 31 Jan 232022 Q4 Earnings call transcript

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

Sood, you may now begin.

Okay. Jason. you, Thank and results everyone, our to call Good QX welcome and the for full discuss afternoon, to year XXXX. again the XXXX despite once a by exemplified was great some of macro challenges. year execution

by CEO, Bob of make comments, other Our Chairman prepared leadership Bradway, from team. and comments senior some will opening followed our members

financial the our forward-looking a discussion, we our and received have slides statements should reminder results of use to our that describe that can make course some measures we just a You vary link have performance, and non-GAAP posted. to Through actual will materially.

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

Thank Okay. and thank and you everyone, for you, our Arvind, joining call. hello,

offer year So growth about for X feeling long-term me the reasons confident beginning why. our the outlook let business, and

volume-driven double-digit that Repatha, in growth and to still of have plenty have we generated room XXXX. in saw full fourth number and a each run, sales First, we EVENITY for products that the and quarter year. volume the and innovative Prolia of

We XXXX in and FOURIER prescribing these extension new important study beyond products from open-label data guidelines. in expect helped by Repatha, and particular, with new from continued growth the

more patients additional all about and share our pursuing TEZSPIRE sales, full indications both asthma. by million LUMAKRAS quarter X% TEZSPIRE $XXX to opportunity a of products a year in of in growth delivered the the severe performance Murdo and types more in the us both especially across we're see patients from moment. to new OTEZLA year, in-line psoriasis. full products. collectively to mild for in being benefiting the label fourth moderate gives utilized volume of that millions expansion and will the We're pleased reach with than U.S. contributed

esophagitis, looks begun for may its trial patients in an we data, more including eosinophilic in for of profile on moved in We've pipeline Reese molecule, attractive II dermatitis, like also And tarlatimab in Dave Olpasiran rocatinlimab from it XXX. XXXX, AMG trials or into Based registration-enabling enrolling treatment early TEZSPIRE X this moment. for action, have in of in III obesity. BLINCYTO the and course, our on cancer. with atopic Second, LP(a), Phase Phase potentially of bemarituzimab, molecules mechanism first-in-class a unique a for

Third, to positioning have for AMGEVITA we have biosimilar positive entrant, the of U.S., first to of world next delivered Phase between that growth HUMIRA told, end biosimilars an growth the wave a in time. we're success. X-month internationally. EYLEA, into industry-leading our decade, the biosimilar to of making X U.S. over source and markets another launches planned success U.S. now less the know the more us we launches, In this to for leading in XX we in be also the All biosimilar business lead in well data us. our long-term and the the to critical We're for AMGEVITA with positioned and And is the around which we than and of will is STELARA, candidates the III SOLIRIS over XXXX, launch contribute these hours

Fourth, vasculitis, a to experience what we've decades added that's look space. for TAVNEOS, we've And ANCA-associated the done, a in on and often that strategic of to said off Through we're strong interest. X start that there. our first-in-class our stated our treatment acquisition ChemoCentryx, in will significant of this licensing transactions presence of and strengthen we inflammation areas we building acquisitions with would in

and a growth will second questions the review the working deal through that for while we received poses regulatory add deal complete the the work add U.S. them that and answer to and profile in we'll Horizon FTC, first-in-class confident of through that are acquisition UPLIZNA request half XXXX anticompetitive can optimistic announced with beyond. first their cycle life year. we in from have Therapeutics remaining several TEPEZZA, early KRYSTEXXA the no the and And to matters. deal of Our additional biologic our including processes our We're will medicines, way that

we've stayed priorities, also drive to our Finally, allocation and capital while true our investing our through returning in dividend. growth share repurchases long-term capital to business to growing shareholders a

everything our passionate due this from that grateful opportunities You'll to challenges our hear year They're to serve Peter contributes about of and and forward on is clear meet achieve the us. more to of everything and last hard on their patients. going mission to people. and all And the shortly. I'm They're we to will how we work our work ready seize await the success, achieved they're them. commitment

to forward look turn but later now the to me little your over call let on, questions I Murdo. a

of for growth Bob. sales to of year illness. millions in We the hematology-oncology saw our our by [indiscernible] continue XXXX Thanks, strong and strong another across of was patients of world our execution XX evolution to volume products medicine mission brands. who record suffer portfolio gravest bring from gains brands. The general the

the inflammation X treat disease. that the of expanded serious with and medicines therapeutic launch TEZSPIRE first-in-class Our area TAVNEOS, acquisition of

deliver XXXX our acquisition important growth in and our growth portfolio. was strategy. U.S. XX% X% U.S. as volume In announced add Therapeutics ex total, addition, to to growth continue of international In several on Horizon the with we medicines will our growth for X%

of volume saw grew the foreign X% year-on-year. we selling exchange a the were XX% year-over-year. Excluding net a foreign decline Including X% product with impact year by X% impact, global offset the full sales X% increase our as strong growth negative quarter, price. in also increases exchange, sales increased volume In product

EVENITY, lower strong bone for the portfolio, XX% XX% general Prolia, record sales offset fourth In had volume X Prolia volume XX% year-over-year the of across these net by revenue in grew fourth business, with year-over-year of which increased XX% for driven bone by Prolia for XX% quarter, the respectively. driven growth Starting growth sales for and year-over-year volume for includes products for million $XXX with health, selling markets. our and Repatha growth, by primarily and XX% quarter, Repatha, grew price. growth. year, volume Aimovig, quarter complements XX%, XX% fourth our quarter medicine the overall driven EVENITY, by sales which partially the full

the the by XX% as selling fourth growth quarter, U.S., of Repatha net In rebates generated offered U.S. adoption for support Medicare by higher broad cardiologists providers. and care aided we Part the adoption access. commercial primary of broad saw we patient volume increasing declining D by prices to in and We

in expect Looking ahead we less year-over-year to price XXXX, saw we erosion XXXX. than U.S.

growth. has treated fourth since to sales Repatha more Repatha's over Repatha XX% U.S., use cardiology grew the XX% million strong position primary patients year-over-year, well bring expanding X.X globally. Repatha patients quarter the of Outside care volume us history launch. setting in to in driven prescribing by Globally, and

much With lowering the clear as data, LDL a world. cholesterol for there's as Repatha rationale around addition as follow-up risk possible FOURIER to long-term patients and in that cardiovascular will with guidelines, early treatment evolving aggressive and the more reduce

patients inflammation patient This from net as the of Transitioning decreased well the enhancements treatment full and quality sales the to co-pay rebates Otezla periods. portfolio. and volume assistance by X% selling saw in offset quarter for year-over-year year. both coverage. new price, lower starting increased growth as X% was stemming to to our support We our additional to programs X% for improve

by launched X programs Otezla During U.S. quarter, business new newly impacted by the systemic and patient demand from drug was fourth topical our competition.

that We in QX continue of impact expect to XXXX.

below X million can with or continue Otezla. psoriasis strong and approved a reverifications, to treatment typical combined and Otezla, cannot similar effect optimally the co-pays primarily from a XXXX. U.S. to to due administration. remains of addressed term, X.X limited We of and a first effect its of safety established growth could positioned prior quarter to first-line mild expect lead to The authorization Longer sales coverage indication strong quarter potential those broad payer sales by insurance for to have well is ease topical with Otezla QX first requirements from to see oral lower being see also to help of profile, and the only we systemic given like be patients. benefit with the relative moderate that whom deductibles the the pattern Otezla in of million therapy subsequent quarters for psoriasis, patients systemic

Physicians X% biomarker anticipated in for ENBREL offer the remains preparing the levels. limitations. patients. now has fourth range and quarter, to and efficacy TEZSPIRE volume uncontrolled which for the the in the of selling X.X of worldwide in Allergists by convenient year-end of due safety. We're ENBREL also asthma fourth profile asthma. and year. patients will without million both for previously important with higher differentiated We're phenotypic any and to for home. across prescribed $XX pulmonologists full net seeing severe record broad the sales TEZSPIRE severe declines continues quarter, product inventory the U.S. driven option million by an patients TEZSPIRE year-over-year price, pen TEZSPIRE patients long have TEZSPIRE decreased the $XXX biologic-naive in strong launch prefilled broad of partially first treated with track a in quarter its at offset and initiation administer with and unique potential its approval treat patients uncontrolled million sales to acknowledge and

million of in quarter. were the $XX Sales fourth TAVNEOS

to and inflammation Amgen's is to TAVNEOS bring integration our nephrology more with belief vasculitis. ChemoCentryx Our us that of substantial presence ANCA-associated proceeding in confirming allow market smoothly, deep will experience patients and

We're of also announced Therapeutics. excited about acquisition Horizon our

diseases portfolio, meaningful our which combined presence patients. a will will Amgen's for deliver lives address [ph] [indiscernible] patients of and therapies make will commercial team inflammatory will and to capabilities include serious XXX global more many Our important allow that globally. in markets approximately the difference combined improve

inflammation, equipped HUMIRA, to this diseases. biologics months the medicine. of decades evolves. AMGEVITA pharmacy patients the is by Today, serious developing the living and significant our used patients biosimilar with and X supply experience coming uptake space, of first With million of expect gradual is in a biosimilar manufacturing U.S. launch announced we first the the biosimilar benefit in and in inflammatory to we this as with medicine more track market than U.S. Amgen AMGEVITA, record uniquely

quarter included KYPROLIS growth government. hematology year oncology onetime by Moving X XX%, and to million quarter. business, driven sales Nplate the KYPROLIS, Full XX% grew to order and quarter. volume includes $XXX the related the BLINCYTO. grew These Vectibix, sales a fourth in which U.S. the fourth for from LUMAKRAS, XGEVA, grew products Nplate volume year-over-year sales XX% XX% with gains. in our innovative

to portfolio data performance future in hem/onc forward the this the Given strong positive recent our BLINCYTO look and the growth XXXX portfolio. both of I Vectibix, and of potential on

from $XX million XX% volume with quarter resulting pursuing launched X% XX than million sales France lower LUMAKRAS unfavorable in a for $XX by U.S., declined the markets in full approved approval countries. sales and the are a in net adjustment growth, million sales rapidly over reimbursement driven now been reported a fourth reimbursement price to unfavorable Outside and and estimated changes in has in deductions. We've selling the year. price more decision by Quarter-over-quarter countries. remaining LUMAKRAS $XXX the offset in XX LUMAKRAS

noted come from lines moving before, the As setting. patients term, on we've expanding XX,XXX for types. ex LUMAKRAS and LUMAKRAS and Longer X,XXX into U.S. the earlier second-line tumor therapy the to we U.S. expect additional of market into in focused growth

biosimilars the XX% driven full Sales lower fourth for the declined oncology and year-over-year price. by of our for XX% quarter year,

increased published both competition. for recently and biosimilars shares, net our While deterioration and selling time, XX% we new expect molecules and growth to accelerating declined by for U.S. business price leading price in the expect driven biosimilars KANJINTI. KANJINTI additional Over by and in continued we MVASI selling declines, volume The launches. the average most hold XX% driven addition for our long-term year-over-year of be MVASI

I'm patients. start our as to And of hard the day who inspired the of the new world employees up Amgen wake around the work we every year, thousands by serve

patients Horizon, expanding presence integration further serve of and strengthened diverse by us many international the products, of announced portfolio globally. acquisition ChemoCentryx more and the position Our of to well

that, Dave. I'll it with turn to And

everyone. afternoon, Good Murdo. Thanks,

of pipeline. continued to X development, and on-time of execution franchise patients results our portfolio research high-quality innovative globally. areas as year millions obesity our In and of strengthened progress cardiovascular was of general we delivery need, unmet we medicine, significant one of For last emerging and affecting assets,

These is no extension FOURIER College course, of ceases. level benefit Cardiology cornerstone of efforts. decision presented by pathway, data. expert And cholesterol appears American be recognized consensus of indicated below November there were to at which we these Repatha, the open-label the AHA, data last which LDL

for a LDL This Additionally, inhibitor not updated patients a is LDL to reflect recommendations large a level without cholesterol patients in deciliter. per highest-risk from were to XX number reduction milligrams PCSKX levels is target attainable that XX therapy. in of

is II in of presented established At safe in or milligrams AHA, that levels where we about every with concentrations both Phase reduced higher baseline by disease dosed Another study. cardiovascular weeks Olpasiran. per XX patients Lp(a) nanomolars appeared Lp(a) data XX and Olpasiran XX% this with XXX% excited approximately liter. molecule XXX we to tolerated are Olpasiran well atherosclerotic

encouraged Lp(a) by our reduction. and data, frequency, of tolerability are degree these dosing profile and We particularly safety

We subjects with outcome and elevated study X,XXX atherosclerotic per levels XXX nanomolars have disease initiated a of III at significantly Phase and least cardiovascular Lp(a) liter.

the where obesity. December, reductions XXX turning body and AMG weight following XXX AMG from XX Now a study weight demonstrated subcutaneous to XXX at Body were data XX.X% day injections. well-tolerated a up observed days appeared administration. reduction after X In presented safe, to final Phase we I in monthly

are explore and we XXX-subject patients or without obesity study The comorbidities. in related now a different with regimens… XXX investigate dosing levels favorable attributes, study Given AMG enrolling Phase diabetes also will to and II with these

Difficulty] [Technical

points percentage on year-over-year down to a Two basis, XX.X%.

year, full COVID-XX a of in year primarily the product fewer and improvements to manufacturing decreased shipments sales changes offset XX.X%. mix. and antibody For percentage lower cost points, to quarter costs, by partially were down sales the full percentage Both X.X of due product our by as

for in by year-over-year, upfront activity business in higher Biomedicines in with quarter was This assets Therapeutics our support X% decreased lower late-stage primarily higher Iraqis collaborations, to support. Non-GAAP R&D and partially offset along due programs. early- key development XXXX, spend our payments product with including and connection marketed in Genera the fourth

of R&D adjusted XXXX for year, increased fourth quarter. full X% drivers investment However, the declined for the R&D spend BD activity, year-over-year. based X% QX XXXX the And non-GAAP on same

for year full XXXX BD increased adjusted However, by R&D investment activity, X%.

our and year-over-year, by in product EVENITY QX Repatha. higher products, TEZSPIRE, investments increased support, driven expenses non-GAAP SG&A including marketed X% priority

for primarily unchanged For other year-over-year $XXX XXXX about year-over-year, investments Non-GAAP BeiGene. the expenses quarter, and were the increased we previously continuous increase million and income driven were recognized a expense priority all as investment our in mature by from fourth in in brands gains the gains, full improvement year, in offset that reallocation productivity SG&A were expenses for by $XXX million mentioned brands.

year, non-GAAP and full income expenses billion. the approximately For other were $X.X

turning to now business the for for So outlook the XXXX.

consensus added adjustments derived of current that It's basis to the some outlook is Our analysts estimates of Amgen-only any as currently estimates acquisition. on into who remember company, are announced estimates. their from combination a for Amgen stand-alone that a without important -- Horizon have along a publicly Horizon from already available stand-alone with estimates

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

key let me now to guidance. several related review points So our

not in to the we from year-over-year will not $XXX comparison will we include items antibody we generate COVID-XX that XXXX several For XXXX. expect not related benefit million do expect from total about in We revenue, revenues assume XXXX.

to a the the significant and Recall, of the by in XXXX half lower several deductions in year. to United in XXXX. Nplate sales business changes We States Nplate XXXX. favorable estimated second XXXX amount a purchase occurred in sale closed which generics compared the late XXXX of that in of Turkey, government sales also our assume Also of included

mid-single-digit with industry our our sales, TAVNEOS. Repatha, strong in trends a priority portfolio growth product Prolia products, by portfolio declines expect growth in our Consistent at EVENITY, price we we For recent level, project XXXX. and history, in volume TEZSPIRE, driven and

biosimilars. and to Turning Neulasta our oncology

through for Neulasta product with than full expect to $XXX biosimilars, MVASI. sales less Further, year in we expect product finally, This We million sales $XXX result less the of trends recent oncology through transition $XXX sales will likely expect XXXX. than we the our combined as continue than we million million. KANJINTI of less expiry DaVita. And for contract EPOGEN our and in

collaboration in to in For anticipate billion a the $XXX recognized of COVID billion. XXXX. to that full our revenue year, don't with we're we revenues of antibody we repeating Note guiding Lilly from other that $X.X about million XXXX range $X.X

discipline. our will with consistent to our expenses So we manage historical continue operating cost

on So efficiencies still and our full and on we operating volumes, sales we be net expenses cost productivity as flat even to versus declining across the enterprise. focus continue year pressures with project increasing inflationary XXXX costs, prices selling XXXX non-GAAP driving

favor by increase This enacted income tax. while by be reducing that Puerto change XX% XXXX We sold sales that range a a PRET in there roughly to the XXXX of charge related of to in of sales first Recall project however, million XX% capitalized in of product Note, Puerto we June the an corresponding be quarter Rico goods tax cost currently mentioned the be PRET, expense the percentage equivalent Excise our first of in charged impact of will cost in non-GAAP inventory earnings recognized approximately will law an negative as tax most cost amount the beginning our in $XXX changes with of Tax, sales. XXXX, of to the our half amount. that benefit. will QX tax is income the the replaced in of to without of a during discussion Rico that XXXX in

expect to invest advanced as XXXX year-over-year the driven to and compared for do the to us capital And improvements. XXXX slightly to a expect expense of sales with is programs best percentage as non-GAAP by our in X% we that. consistent expenses innovation, spend, SG&A Reese amounts to operating a year-over-year, This decrease referenced discipline just our our non-GAAP Dr. product increase capital number provides allocation productivity the R&D earlier. we We of XXXX priority to expenses in first X%

a XX% of percent as projected year basis. of lead roughly These all a full a margin on product operating to non-GAAP sales

driven income our on change the GAAP of method under on our and now longer only in expense investment Beginning for our recorded by of is We we'll BeiGene mark we of our a no expect are our expected accounting XXXX. $X.X share impact and January equity The approximately non-GAAP other income year-over-year the in to making in accounting record statement. billion. improvement BeiGene expense in statement. market XXXX, our non-GAAP We'll income with investment results income other

reflects a as Puerto beginning XX% tax, earlier, We Rico explained of I the PRET replaced rate the rate XXXX. in XX%. to expect which income This tax non-GAAP new

increase will share expect $XXX XXXX, and We that not we expect meaningfully repurchases exceed in to dividend. million to continue we our

We $XXX to our our priority facilities invest in XXXX, we in expect we allocation million expenditures including North business, expenditures capital consistent complete Ohio, levels. to environmentally-friendly our facilities, And historical return to those our capital with in capital approximately after of in new their Carolina. expect

I'd specific performing year. the through XXXX. of as our first make like comments the is business that also the quarter around encouraged month of to some first I'm expected

and sales including our quarter above, we first to revenue year However, to on lower a the historical be of consistent in to slightly to in the expect the of other revenue revenue XXXX. be with QX XXXX. due million sales At from we of year the year-over-year out set be about first related the QX expect patterns, the basis $XXX lowest portfolio to revenues reasons quarter XXXX product a unchanged below revenue and antibody in quarter COVID level,

in million the million of $XX than $XXX XXXX. about quarter compared foreign exchange XXXX anticipate The first total We headwinds of versus all creates QX greater QX XXXX. items these of to headwinds

into along for of Recall, QX this our a patterns, percentage all to is operating with XX% revenue product expect continue roughly below expected percentage XXXX. XX% to non-GAAP of sales, operating timing be Amgen product these margin we to of as are sales the a stand-alone. all being translate as of margin So although expenses,

focus excellence. to on execution legacy of continue will our We

keeping with in delivered another year In deliver strong financial and track results summary, we macroeconomic headwinds, long-term of our us despite to through XXXX commitments on XXXX, beyond.

the updated guidance long-term which in Our transaction growth our some completing the the prospects. the XXXX, Horizon provide only of we strong, announced of first will and Amgen growth is expect point confidence closes. at of strengthen forward look acquisition as half We to would during appropriate after to

to for and tireless patients My their update. their at financial commitment concludes colleagues serving the XXXX. world This the to Amgen XX,XXX-plus our in efforts thanks around

turn over now I'll back our Bob Q&A. it for to

here. the Okay. And some Well, thank despite on in disruption you, to technical difficulties. us call you to apologies of soldiering again, Peter and all on join in who've for the dialed found and the who Dave, proceedings

read like A I'd questions and have questions, e-mailed wrap of try What them we'll me if all questions suggest of have here to to that who will is to you that available up. conference you answer to available let it the and your in you directly you have call, now team will And to and this answer room. and them, Arvind be Arvind. don't schedule questions to them assure any number be e-mail to his we Arvind our we of get rearrange to may after just on we answer Arvind

to Arvind, the tackle with So turn and questions that, let we'll me submitted. already that you've

directly. Yes. And Bob. we questions me said, apologies everybody for e-mail had. And difficulties the have to please that Thanks, as just technical to your Bob

first is equity the His accounting for X that Cowen, submitted question that value to of first So and is Werber Amgen from we fair BeiGene. from move will question Yaron of method questions. have he

BeiGene's is, of half III on? the And Amgen of you As AMGEVITA and Phase in second question will now get less data interchangeable to once first in the XX.X% the profits concentration losses you plan also from can own then equity you than high discuss when stop XXXX? now BeiGene, the consolidating file you

Pete, in hit pieces. question? X don't that why do We accounting you the Okay.

in remarks, Yes, Yaron, the answer. accounting, my non-GAAP for won't will I equity statement. income in in our of mark-to-market GAAP our method record, statement, as be Thank quick BeiGene we the but recorded income question -- quick On you, that said question.

in answer any as include losses going statement. BeiGene non-GAAP -- not will our earnings we So our or from of the income is forward share

some And and to we Dave X-parter a thoughts. on then Reese why don't there? AMGEVITA, add Okay. want then Murdo, do may you

Yes.

of guidance potential in I filing after me once let we the important, It's expect the then terms giving to filing to In of data be were here. that context, as regulatory have approval think, interactions. comment Bob we this and the Murdo we'll put as lines, appropriate when in hand, time ask

Yes. Thanks, Dave.

We some had that questions have day, the are during can on we as imagine, this, you inbound given launching.

well. is launch progressing far, So

making patients. the payers, prescribers into from we're We and interest way and have product its receiving AMGEVITA already channel, inbound in

that's product One adalimumab, is been is through patients in our patient clinical of is important are the volumes here remember AMGEVITA here concentration have the patient has current not being still a a we able not a trials, that original that to minimize thing the citrate-free it in that meaning but are by in where market X is very, we've having And auto-injectable or anticipate high concentration, we market. and concentration a reliability the experience very lower experience citrate-free, administer. injection that will seen very site pain And having positive injected the to be pen. barrier an good low we formulation. These

to that support nurse patients for wasn't And then of are the I think support also launch and and assistance, providing note provide support as we it while reimbursement for important prescribers both asked, we addition, we patients. it's course, In product. financial

of So launch AMGEVITA. being would for adalimumab, biosimilar, launch in applied is really first a to the that the U.S., support the that of a full to launch and branded expect you suite services

and Murdo Okay. Thank you, Dave.

Arvind. question, the to go next Let's

but AMGEVITA And biosimilars all next STELARA, the BofA or from said, HUMIRA half are indirect in question on you volume And is and from the So [ph] expecting 'XX Merrill an I his and you 'XX impact. from of Meacham impact ENBREL is the Lynch. have interested of is, he first Geoff the half Otezla in question know the price mainly? and second he

that? share thoughts want Okay. Murdo, your you on to

of competitors a me, for we've other have to both biosimilars ENBREL coverage been into able may we on what of hard negotiations, very secure the July. seen It's Otezla. adalimumab as enter and market XXXX obviously, a for what good to cycle comment reimbursement and But do beyond coming broad is

small We net is expect to to secure had price XXXX. course broad to reimbursement, unusual compared throughout as usual, nothing continue coverage years. we insurance prior that of on but And the concessions that

Sandler. Chris Raymond And X The next question is Piper has from from questions. he

And a a patients this into of The on unique of mild-to-moderate there therapy. have guys Otezla. in Otezla discontinuation know puts market, that says, there I coming know rate. takes and first you tailwind highlighted and on But X are is is of psoriasis sizable Chris lot is a kind I

both more not maybe Just about this coming going importantly, be even of noticing be we molecules as are how a then away, shouldn't in on and the any through you're why on about U.S. the competition with decline Q-over-Q question AMGEVITA. helpful. has grow behind concerned [indiscernible] that the and probably world, build, X% with very inventory color talk you it. that, would just if a And next-generation Especially he that a coming rest

Okay.

regard really for patients start So Otezla, psoriasis first the on range the systemic and severity, indicated of makes that systemic product I that without would positioning post-topical choice is first-line the of with as potential by patients is of to patients the ideal could that the a would And fact switching to of broad very treatment first we are of brand. the us doing regarded The not million therapy. market only a systemic million like size those psoriasis. as Otezla. as topical they well moderate of form with X large. X.X a mild About be to on There's

that it these access, broad mentioned patients They to And frontline first start that also ability As choice. Otezla Only They means Otezla market. something And is few prescribers of for to can provide a quickly it a that's the lot doesn't in very systemic make busy paperwork. easy. an therapy. offers step on through prior dermatologists. don't it also And just are be you another able moments that enjoys that want ago, want their require the psoriasis therapy. I they to want

to effect what a now into sometimes I or sometimes goods opportunity were the launched product usually of of access last beginning physicians novel we're think benefit number When programs bridging managers, programs, will and of secure that year there physicians at goods at have when programs of coming try the free the used a end an as to referred those an market. been therapies launch into is seeing right free use continue to this with pharmacy hasn't quarter.

And think that feel to I the growth as will really of the the therapies go those However, And prescribing competitive it base world, free and the try from through and of access more sure impact process oftentimes, continue commercial becomes good we're PBMs around that therapies of allows of growth novel difficult closely, have post-topical nature say where in from in opportunity. systemic our because to sustained those the And of number population us dermatologists. in a to and patient advantage that's feel programs, Otezla the in of the a this prebiologic hearing be really we confident that long-term good we we're they with. continue continue with markets long-term I negotiation first-line strong very we're we making these it result novel brand. to of what very short-term watching presence the that we a payers, marketplace.

drive market on think could Goldman we once second question the you will are Chris, have the midyear question What And your the pricing? enter? Okay. option the of offer as more says for details Richter how and that is dual And we how she in from expectations biosimilars more pricing on work Sachs. AMGEVITA, net the Salveen same should about uptick?

second the the and I answer answer first. can't price. really can on net don't product-specific I part maybe comment so We Well, pricing,

of the requires their Pharmacy net we other employer complexity to that really the rebates come fair We've into market, address the I here price market. list that to say list employed With here. but managers prefer a manufacturers, biosimilars so respect and negotiate price they this to those have is approach to then would upstream that X price down a the expect seen with think net we've rebates to business additional launch, the that this U.S. go prices it's pass usually entrants high and in and would rebates they clients. that benefit at to down. happen model negotiate our that as business, through

gross system price. list that about difference care net health the and net prefer price in between price-based the customers a and and or and stakeholders other model are don't There net care

And product so price lower we have for net those, the available.

XX% below reminder, a list have X% then we HUMIRA, price So at below a low and price list have high at we a HUMIRA. just

is to patients for providing an the co-pay as intend well helping assistance affordable that ensure by as through also patients medicine AMGEVITA reimbursement We insurer. secure

out We managers, the are access gate parity benefit broad report coverage we of pharmacy with so broad the also of pleased enjoy launch alongside day that X national HUMIRA. on X to

you but me and set of until have time. answer the the for continue to past the questions we take that of transcript a there as is long up will here note -- just hour, of for beyond conflicts to I those necessary Let to in we're questions form those a that the as that this available can't be recording will and stay half

So Arvind, the next why don't you question? go to

this when get should expect question next we expect The updates, XXX, for AMG from should remaining from a to Phase the And this And asset pipeline. I on we from Yes. and data X UBS. study? see we obesity more Bristow on then What the the Colin cohorts disclosure is year? Will on program? here's update question

Yes.

or to, you're agonist the XXX the mechanism a XXX, don't of to that. In is course, or If AMG of I'll of that see molecule data course action, that as antagonist. small this Gipper GLP-X referring guidance. year I AMG X the a we'll indicated of obesity changes, provide different know cohorts with additional terms receptor on over pipeline,

may through the well. So course, that I'll from target provide at talk course as dose the of when escalation over data in that's about of And we'll we time the going the guidance data program. availability, of year. see terms of

go David. question. let's Arvind, Thanks, next the to Okay.

question from expand Capital to to know, your may the you the on next better commercial said Evan And BMO Seigerman the So potential from Markets. is with revised can you Evan slowing have LUMAKRAS align sales, of commercial assets? strategy with wanted he how

sure Yes. I'm slowing have overall a we growth. not volume

a mentioned might I but not come the finalization reimbursement did based and what think audio, on this, we on decision reaching in have saw the price through in we quarter, it see France. effect I clearly

incident so opportunity anticipated in It the LUMAKRAS And think volume population. million I that the quarter we for in LUMAKRAS. we $XX quarter. opportunity. had commercially in grew And are the second-line sized we to for appropriately against But medically limited being the charge X% a and

tumor into therapy to we invest as think continue behind lines other of earlier we expand I or product. will the types,

Michael Michael of is last And is growth input as revenue is EPS positive than impact question XX% from next the the is explained And growing range? on XXXX impact from guidance, negatively Or growth revenue? he The to XX% versus Yee. COGS accounting? rate OpEx does Specifically, Okay. is said, wants XXXX BeiGene to EPS? know, you for what offset, tax there can year, more clarify a

Arvind, question. way the start let by tax me from working our

the is it, So side amount. of XX% the the by on XX% to increases tax

Although, capitalized year during that goods first be about corresponding a this that both that have me, will primarily excuse in a and carryover sold, last cost I in the will small in goods of $XXX that's effect cost sold the year, we inventory currently as have tax quarter -- of benefit. released without currently highlighted capitalized released of million be

the answer is, the that which roughly Excise way recorded through forward, the it Tax will from down works or Puerto actual $XXX million goods to of the Rico equivalent was tax cost be PRET, So after rate. its goods in to sold, income going sold of move cost

The what's BeiGene question question not. on included guidance. and And I from think was, the what's

income. included our now to either earlier is of in be won't what losses said gains or question, I BeiGene's Yaron's As share

in security in GAAP our we of include, statement, the income BeiGene then So mark-to-market the but in not our movements on non-GAAP income statement. a will and the basis results

of our losses will no their share record or income. longer We

you on you make just the Let saying get understand response, more back need in if and Evan, you. sure detail question me just what Michael, say, that to we'll know, our fully prior we're to from us to let

Evan, to color disruption going lot if Michael, to familiar question, if the here, were that you you. not a earlier. on follow with happy particularly, mechanism to Again, I able France, you're that's slides know and know us your provide don't the more for for common just think all in I and apologies for

conference us the call. So more need call color, after we'll if you back let you know,

Go the ahead, question. to next Arvind, Okay.

put need have data TEPEZZA would for could to we second Phase you opportunity a positive context drug? us? the the Then the upcoming chronic Salveen expand IV What see? data asking, you from Okay. and do for question How

subject on are anything to We to our say the the restrictions documents. that in what's on we have ability

to address You that? want

label and I I reimbursement everyone that broad with believe a eye is that that autoimmune patients that course, say the we difference the we there worth and the thyroid is would due encompasses -- to reminding Yes. This I And comment here. let is and to restricted, think mean, is by can no that out of help rules thyroid takeover in on What Irish primarily it's current disease, thyroiditis. will form acute will point between we're generate with ask eye payers. the population data me disease. that. Murdo of disease chronic mechanistically, with a study

study. part driven that pathogenic definition fact, by mechanistically, And of about therefore, being In progresses mechanism the data when Murdo? disease on IGFXR optimistic form intact. it's and large we're a chronic as underlying based in prior is the semantic [ph] to the but to

doing I promising the growth to a I mentioned. Look, think within already product the is broad could here continue additive current be think team job patients this Dave Horizon good many and commercializing very data additional And very of help indication, the the as Yes. product. to

question. your for Salveen, Thanks, Okay.

the go to Arvind. Let's next one,

few how orals Schott Christopher on seeing would an elaborate impact quarters. from is seeing initial drug year in anticipate this Do in from over you of some for impact that program The for that strong they continues our their an XXXX? next suggesting bridge year? are of Otezla. can JPMorgan. something in is Christopher lessen much expansion competitor uptake interested Bristol saying, and And be will the versus And Otezla much free as you're of or you mentioned the market you impact the next X

similar Yes. are moving a that to I topical a a and earlier, well-understood treatment It's patients perhaps to product systemic dermatologists Many It's try use bit Chris. the hesitant clear but first to product a post easiest safest elaborate can and question these X topically. for agent. want little of when to fairly asked systemic

And over so with patients and efficacy this I extremely this experienced understood. having well safety XXX,XXX Otezla's think extensively is Otezla profile is where studied of product, the globally

it a that for frontline U.S. As secured lot a I prior patient systemic mentioned earlier, without especially dermatology practices very and coverage convenience in good access milder authorization is of really for the clear, a more with first-line makes of the treatment, we've that disease. moderate or it the treatment, requirement,

going given something disease, go has it like not that really to going payer actually we seeing term a severe you're For use that or or biologic we're through reimbursement, that And marketplace. likely to need moderate to a market the be longer and process used yet is access [indiscernible] agent. think the how secure to second-line it's in

uptake be And the I for programs what free think sometimes, a can actual product. distort curve these will good

time, not is there you've are dynamics pricing resets XXXX about given market? HUMIRA expect about ENBREL know I why remind He's bigger Chris. a the thinking from second accelerate. step-down Can Murdo, but price price erode significantly? asking, in a over down Then question how the price you the you expected declines to as significant us in talked HUMIRA price market shouldn't or continuing in we XXXX

I mentioned precipitous access. to but our as good that we're and cycle concede Well, years. had mentioned, a through of anything We've primarily I looks price, to before, we've not XXXX bit prior secured very compared as

pleased is well an We and the understood. we're for safety many see is with of efficacy important So that. profile ENBREL indications. that product ENBREL

I product And that's and in to the we And what open are future. think physicians choice. continue on to we'll achieve think X to secure their really PBMs where able want also to TNF we've formulary. also having able than more what think be I been that's I think

to the go Let's next question.

we And progresses? of launch of them for Wells and the from cadence year And as different competition. there's next question first is HUMIRA is biosimilar about about your talk the bit far? pricing half with his has is, Are should half parity Mohit Seems Fargo. the how second more you your the contracts more versus access think Bansal the and similar? could The question little thus AbbVie like negotiations from majority a

and I secured payers. a access competitor's the is AMGEVITA PBMs broad contracts What X comment we've can't I Well, can PBMs. say on at for national with

access everywhere other of in have to continue alike. done with continue patients outside provided else the U.S., And provide the as we'll position We customers we the with and position were think, we in we compete And this providers leadership very effectively for services have, and footprint product. biosimilars. work to vis-à-vis competitive world able establish And we a with good given a we've other AMGEVITA. we're that to commercial the to

the questions, couple those to work shot I going we're have to e-mail, submitted through an who we've handfuls yet know a and of of number through still hasn't go. Arvind continuing Anybody list. go so we're you got to

So go let's, the question. to next Arvind,

approaching recent is X by Markets, conjugate How you. next some question a space? this deals. strategy were in Dave, the The is in the Greg is drug the hearing of Capital light interested of team color for and Renza We antibody Yes. RBC on the

course, on an advanced, and collaborations extension What I so our this closely feel that past an as, it together watching of years. of several we'll what well and target the conjugation of modality as view quite antibody is These technology. Greg. some Yes. bring another conjugate generation newer addition targets. for validation the our ADCs experience technology modalities. toolkit. as is the we on view with appropriate identification as Thanks, I our been We've use drug antibody in It's

our that more as should So progresses, to additive view but you to as come, armamentarium. this

asking, The question comfort for consensus is there's go anything which he's sales, them contract of as and about of on XXXX? Anderson with U.S. commentary Tim price next question Okay. specifics such sell-side you And by AMGEVITA in $XXX U.S. whether protection, And Research. the your in can his is Wolfe million beyond any to And XXXX? be around say if seems any

event product is this guidance. a biosimilar U.S. go the given in market, product-specific new And big benefit is we don't Yes, pharmacy give to the first this up.

So update the we progresses. continue of all as launch will to you

we this will said gradually you and be apprised keep have have we launch, think to going as this slope go on We I'm forward.

of Risinger next is Dave and he by Securities, X The questions. SVB Okay. has X

Murdo. key second for potentially And change in for is you, watch Please January interchangeability first AMGEVITA an XXXX is to Dave. readouts expect assigned in AMGEVITA designation? XXXX. candidate the for discuss X How positioning novel do X after The to formulary you, you drug of

David. This on Yes. execution, pipeline. is focus in where will a Thanks, certainly my huge team's amount to a year be forward the my focus, carry

the to. III initiation of there are research. course, the disease. in but tarlatumab I rocatinlumab and earlier half second II we line of And enrolling the that on are, in an the trial? some on, trials indications? program, be And keep attention the well are portfolio, how additional are in TEZSPIRE would suite Phase So enrolling? How are then an Phase how Phase How second-line are top we paying not readout delivering only things eye a in of that are a things AMG of the finally, pipeline the Phase enrolling trial? the year XXX others These well things in of oncology, Olpasiran trial host registrational I'll the keep in of the also discovery general eye III inflammation, then II potentially to on In medicine we trial

that for. our switch I away product reason And with to from we're that sure of question, would biosimilars attributes we there all make continuing to trying And they're that patients to benefits to in range. of commitment is on AMGEVITA ensure AMGEVITA provide that payers, the just say the no the the long also have looking a providers and

good indications we this long HUMIRA, AMGEVITA and the the well, who customers a team of about the that Amgen the with have very beyond fact of is high the they market, with have we inflammation fact with already term along relationships understand this on durability hope people citrate-free the really concentration along prescribe of product provide, we product that and feel XXXX. services an we the interchangeability, So that that the

X Raffat from questions. The from Umer Okay. is question Evercore he has and next

said, trying through stepped for extended an that post from to XX%. months you, OXXX XX% is Dave, versus question X quarterly you, dose. the the in tax investigating first I'm interval dosing I Phase and monthly up seen Peter, for dosing durable arm the III The is second And to He III. and efficacy just intervals or last the rate on to Phase don't tie biannually. see the X XX%

to wanted some Just additional get color.

Yes.

dosing of the Regarding rocatinlumab.

indicated And well I before, on looking action clear there suite the will of become as different the of we've of as Peter? here. we mechanism explore as for we're both fully will patient launches, molecule As think based III Phase that convenience. it dosing trials paradigms what

what on Puerto income the a of say for to question would actual change P&L, line XXXX. real with in expense Rico, a Again, Rico tax the cost just in which on from in the is tax. down which sales Umer, the good it's Puerto PRET I to estate us from the change income in PRET moves tax began connection in the here

nature we've and that's change So been the XX% to from in that's here of that where the XX% where historically. comes

have in Okay. there U.S. ex about we The your you Olson any mix U.S. what talk are future dynamics and past Jay percentage Oppenheimer. revenues growth. Amgen's question in And if can is back plans few other of mix that diversification? underlying dynamics geographical push or geographical might launches were geographic over shift that of wondering favor revenues become small for is drove And quarters. of a the total Jay the It next like ex from asking, seems

being actually over the the expansion with internationally Amgen are very XXX Yes, in we pleased of markets. footprint

secure world. and China, talked we've and And drug reimbursement to around able listing for national reimbursement been products LUMAKRAS. secure Repatha. in launch the most Prolia I about recently to continue We both

is well. affiliate Japanese growing Our

just In U.S. a partnering I recent coming in history, bit launches a of earlier is the think the function products. you're some our also seeing of of what and timing

will JPAC interesting actually large around longer term, And think that is to a got opportunity we announced opportunity region acquisition we've internationally. I is very portfolio potential the a has their Horizon continue see of way what make The very longer products our world. our fastest-growing term.

will States. wouldn't the trend prevailing grow I The short-term is movement long-term So United outside quickly quarter-to-quarter. that at we look from

you, in Partners. XXXX Otezla in Guggenheim beyond, low since achieving how of And from double-digit sales Schmidt of Murdo, $X.X for question Okay. billion? next growth he's flat confident are is Michael given of XXXX you asking, current the and The pattern essentially

I think we our remain Otezla. growth Yes, confident long-term in quite of

there's market the product of starts. where a lot competing entrants We patient are period for a in new new in

product, coverage think perspective from market. of I I insurance source particularly unique U.S. the And mentioned, to around positioning patients. a the pool the an world us as the large penetrate and reimbursement to very in of allows our allows us that

very So the we feel Otezla. good about prospects grow continued to

question Okay. Truist from is from The Karnauskas next Robyn Securities.

potentially flat implies guidance growth. your picture, big asking, she's So

Given biosimilar the can biosimilar pressures year? pulls guidance on pricing the And give range? is you a do regarding think trough pushes and you and range, XXXX pressures,

through Robyn, said now can what last reiterate 'XX. on launch the piece, maybe those molecules I of the us is and United start further my other have said continue in and States I'll the decade the which countries remarks, So will you similar end and world. the But of it to planned the then X And in we as we grow time Pete, franchise. around about that to Robyn, enable between launches

would I said earlier I reiterate in what comments. prepared my So

want in opportunities whether in though I here, respect have launch. address think Murdo anything year. you've to we'll the what about to Pete, well that we think heard the already with you day And in have with addition say outlook as you first 'XX, I particular, to know attractive don't for we're the AMGEVITA of the

Thanks.

to lower covered half in occurred assume significant that 'XX, Robyn, happened deductions a 'XX just in purchase sales to earlier. changes We U.S. benefit COVID-XX 'XX. sold those. closed just and the business note any 'XX. Recall, any in We're the we that generics reiterate by to compared I of had 'XX, 'XX, the had favorable we in government the we several late don't expect second it in Turkey, sales in and didn't XXXX of which the We that revenues 'XX. year. estimated think assuming a Nplate items couple I'd in antibody of amount from expect in

those. So puts around and a couple of takes

priority and recent in And also portfolio, look XXXX price we Prolia, good but And Repatha, in strong consistent history our that's trends about with growth mid-single-digit growth. TAVNEOS. light products, year declines in to forward so of, of since our with -- in talked our in a with we the volume industry --

in back outside go I volume Jay too, we growth United expect to think asked, States the XXXX. the to question maybe strong

we're 'XX So to forward on lot of aggressiveness. looking taking with a

the question year-over-year year-over-year next William decline erosion guidance Okay. the of Matt's XXXX rate biosimilar decline 'XX oncology beyond to floor? of in XXXX or oncology 'XX. Matt XX% Phipps this The a from from biosimilars is XX% expected to versus a hit will Is the And Blair. of suggests something continue to saying a eventually get of larger

see wouldn't average I the which far. a that larger expect get to it seen say that but decline we we've is selling in a decline will business, function continue of thus to price we

don't XX% He What calling. in to confused up COGS while I Hence, line. tax offsets XX%. to missing? are see to XX% I the am by going COGS the said Yaron I'm XX% rate any

that question. Yaron. volume that's think the that is I to quite our is growth, volume a really the That's offset, large and answer good the growth

that And so happening. see we

million too, of out into corresponding provision. cost inventory terms sales sales of the PRET the got the in $XXX off tax move we've in of this year, of there, any of coming down recall, in -- also release We without of cost

of to income versus itself. got of of percent sales about too, a thinking the provision so you've the in tax percent be And that pretax terms

But and XX%. that. to strip expense that's the of XX% the all into puts down to effective it's So tax takes that income the move rate increases back, when PRET on you that it the really that

Credit Otezla Okay. Thanks on for [indiscernible] The and next the is Suisse. from question ENBREL. from comments

changes you of in channel the disruptions? there there bit can any in a patients? So Are immunology? been into more mix and color formulary dynamics Has any add the

looks immunology very Overall, good. our business

pleased I the with think launch. TEZSPIRE we're very

of status to treated. being biomarker patients continue see of We phenotypes broad regardless

from being seen of novo asthma. other We de we're in seeing uncontrolled treatment switched haven't before And within a products seeing are patients their patients biologic class. who also their the

And of we expect of that of for to autoimmune positioned that compete asthma. pattern. biologic terms penetration we're expanded treatment in so well growing disease And area severe the uncontrolled

seeing some the And we programs, ENBREL are pressure then drug free fairly serve is as consistent. many both there for mentioned, predictable well as Otezla, trends new as And fairly entrant new cycle early product, continues to our oral its I of from topicals and lot patients. TAVNEOS, very growth and to life also just in have up picked ANCA-associated a really product young there vasculitis, autoimmune which about, be disease, we're severe had. treats very excited a think a that we've

then, course, And of side, last announced of certainly the on least, but the Horizon. branded acquisition not

think is own first the on the term. largest area, launch for inflammation a we pipeline of are in product HUMIRA. that's us And of the very long I to pipeline So the good day with opportunity innovative not of our least, and the Horizon a along U.S., here last but novel and growth biosimilar

So I opportunities a think of got we've lot for growth ahead.

Arvind, question, want you I last think we're down our if to to...

Yes.

have the comments. concluding you Bob, after question, and some that, read me might Let last

you tax wants Skorney the rates question the a of more to Baird, major to changes and know, expect assuming Brian of do to Brian be So U.S.? from is in last corporate longer-term rate, tax no this

think, I know, you Brian, on long-term we rates. give guidance don't as Yes, tax

the we go as XX% of opposed this to to to a pretax make PRET is change rate, year, percentage in which go And to cost income. beyond so income won't the own PRET. just its the sure so And XX%. back we your sales of The is tax understand

a difference Yaron that's to little bit of about. the that So asked

that's where we'll to you and we're what this give we'll XX% -- year where for now. XX% So at, is that's

on vendor's your the Well, little with much, bit Apologies a had earlier difficulty patience. thank that very for of we connection you again, call. right. our All

Dave shoot the this to myself, you you if into around Murdo, to be might look any So during forward them We'll and to any Arvind. afternoon, have we you. here the Thank further course talking Peter joining XXXX. answer And questions further and of questions, appreciate you have. call your

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