AMGN - Earnings call transcript Q3 2024

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Operator

My name is Julianne, and I will be your conference facilitator today for Amgen's Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin.

Justin Claeys

Thank you, Julianne. welcome third and call. XXXX everyone, afternoon, to quarter our earnings Good Vikram and Bradway and our review Gordon, call lead performance Jay followed Murdo Bob the broader be will Griffith. Peter by a by Karnani, Bradner of

we this Through financial use call. and provided measures discussion the within performance non-GAAP appropriate our will reconciliations the describe materials our course have of today, to that accompany

can some our note also make forward-looking materially. results safe that statement, will are by statements, We qualified please harbor and actual vary which

Over to you, Bob.

Robert Bradway

you joining us today. Thank for

Our across performance and quarter our this reflects the our geographies. of strength business areas core therapeutic

Our advancing in-market billion long-term quarter and in pipeline number significant our growth. double-digit first-in-class quarter $X.X revenues our of with sales products delivering with best-in-class for a medicines third us performed potentially medicines, well positioning XX or growth. of to rapidly up or also XX% better the We're

Let me address MariTide directly.

we later X in Our well, MariTide, progressing ongoing to and program type III obesity-related launch well including advanced forward II We're for obesity, results conditions study Phase preparing broad Phase year. and look diabetes. sharing a to is this

may that we recently in patients initiated You with type have diabetes. Phase II X a noted study

interim will confident including needs analysis, after MariTide's differentiated diabetes. that profile X type As shared a number we address the medical unmet diseases, important we're across of

oncology. start obesity, we Beyond have momentum our therapeutic with across and I'll of areas, each

the innovative which, is conviction X cancer. underway small launch leukemia. and B-cell which in our with Phase third strong III care BLINCYTO, XX% strong cell of lung bispecific clinical is of engager portfolio lymphoblastic and saw in-market growth standard we oncology the as In first or across quarter, products with well growth, course, established the cell experienced our performance IMDELTRA BiTE several of progressing now including The double-digit studies BiTE, in T sales also is acute

clinical promise to will development announce daluritamig into platform tumors, today of III further strength in quarter. Phase advance cancer the prostate And this in solid we that the fourth and in demonstrating advanced we're pleased

out for remind should Let me months. you in data bemarituzumab have to cancer, we next III gastric Phase the few in an eye keep also which

disease TAVNEOS. into KRYSTEXXA, of are are early delivered geographies. medicines year-over-year, new the highly and in TEPEZA, and upside still life expansion UPLIZNA driven significant XX% $X.X stages portfolio Our indications by These in cycles rare innovative, sales their quarter, potential, of and have billion including the growing

data other in by In excited We're inflammation, we're potentially actively B of For example, recently TEPEZZA in growth in therapy COPD in myasthenia inebolizumab year-over-year disease, potential in quarter. of promise Japan. encouraged cell-mediated strong exploring. was and autoimmune granted designation indications gravis TEZSPIRE about these XX% with in compelling the the UPLIZNA in settings also We're TEZSPIRE Also diseases. IgGX-related approved rare breakthrough and was demonstrated the diseases. generalized and additional its continues that trajectory further in

most osteoporosis. General again demand as And Repatha growing in that volume worldwide disease the meet and serious some address each continue These EVENITY and we are strong to more health Medicine, the therapies heart are pivotal this patients challenges like for finally, serve quarter. of and products delivering growth

ahead, Amgen that growth long-term our of therapeutic to Looking we innovation across and areas. remain is well confident positioned each deliver

think Our of will the balanced pipeline, our strength our business portfolio, combined we to with forward. continue drive

patients. colleagues like Amgen unwavering always, across for As thank their my to to I'd commitment

to over to Murdo. want the turn I And now call

Murdo Gordon

third portfolio, our XX% quarter, collectively sales growth. future growth core driving and including grew in growth. are strong of the year-over-year product that across in was Prolia delivered double-digit trajectory. Starting by third double and of grew TEZSPIRE, of or general XX% our medicine volume EVENITY growth. areas And Each BLINCYTO, Execution volume therapeutic digits EVENITY important products Repatha, XX our TAVNEOS, sales the regions our with brands year-over-year Repatha, driven better, Bob. all sales by Thanks, to quarter,

serve these therapies. with populations large patient We

Prolia in alone we favorable for year-over-year expect saw the estimated XX% now lower over annualizing sales. partially year-over-year XX% third Repatha quarter, XX X%, quarter, deductions and billion million million sales we example, will at the volume $X of offset In of For patients price sales to help growth by selling and over Repatha net $XXX in of to changes XXXX. XX%. increased

care the physician was primary payers. by and force of efforts removal volume XX% growth in increase drove care expanded field our enabled prescribers. broad authorization by In U.S., reimbursement a year-over-year several U.S. prior requirements primary

the with ordering increased Strong continues EVENITY. the XX% bone volume grow U.S. U.S., Repatha prescribers and volume leadership accounts was U.S., new despite a in supported the of the be almost growth third new an segment to EVENITY leader to market. by builder established $XXX retains EVENITY million in XX% segment. increased XX% the In quarter-over-quarter markets across to in from continues year-over-year major the increase provider Outside competition quarter. prescription and both category for increase sales EVENITY with

EVENITY osteoporosis. has builder Japan, approximately Since the prescribed a for XX% growth in with been hold segment. women risk growth. their In launching of position in volume to are third globally the to We're the encouraged by by $X to Japan quarter, to sales the driving X% patients. EVENITY momentum more help due EVENITY approximately conviction we XXX,XXX who billion continues fracture billion. annualizing and post-menopausal leading are of year-over-year Prolia remain in the driven for bone now $X.X sales a increased to at X% have XXXX, EVENITY at many potential

year-over-year third X% more by broad This X% sales the see net continues so its In this growth growth million We're pulmonologists. TEZSPIRE to Prolia accounts the the inflammation, growth. with increased In strong asthma. Sales $XXX base supported TEZSPIRE's and provider of for with X% increased was worldwide sales quarter. in trajectory the quarter uncontrolled its and year-over-year, profile selling to offset in the decreased we uniquely treat patients with year. lower by X.X date far TEZSPIRE U.S., than volume adoption severe differentiated using potential by price. XX% prescribing encouraged third million XX,XXX with Otezla by volume

approved Otezla the a deductions treatment. X% price. Enbrel remains X.X cannot quarter. with year-over-year indication grew by net than help third systemic who optimally unfavorable quarter, selling more well primarily oral topical U.S. the is sales XX% decreased milder and to million XX% XX% psoriasis broad addressed therapy sales by systemic lower the Volumes be for in patients driven a with treatment-naive positioned only estimated the changes and to

volume, price, forward, Going declining stable relatively providing our flow cash expect we selling for net strong business. continued

the increased X% third quarter. in Sales of our biosimilar products year-over-year

support deployed in U.S. launch our of fully of EYLEA. the team to recent a PABlu, have biosimilar We

Our by retina specialists, teams from and feedback moved we're quickly encouraged customers. enthusiastic to engage the

for XXXX, U.S. launches to and respectively. the a BEQEMvI, ready teams Our and STELARA are second of biosimilar to a quarters first biosimilar the upcoming WEZLANA, in of Solaris, also expected

deliver XGEVA portfolio Overall, Vectibix, returns XX% price. our third biosimilars efficient business IMDELLTRA growth year-over-year of and $X year-over-year quarter, volume X billion driven over to BLINCYTO the sales selling to continues quarter. grew by quarter. products, oncology, in higher for $XXX contributed BLINCYTO, our XX% total, for these attractive products KYPROLIS, by the sales million In LUMAKRAS, In model. sales the our third grew and Nplate, driven innovative of third net

B-cell Growth approved regardless use for now status. and in chromosome-negative Food supported by Drug in the the Administration with U.S. the the measurable residual was by label, Philadelphia consolidation recent patients disease of of ALL BLINCYTO expansion phase

community academic progressing Our clinical and launch well, of conviction U.S. million IMDELLTRA both strong is quarter. There's in in IMDELLTRA's $XX efficacy. by sales settings, of generating breakthrough the third driven

to living to have a We with patients strong IMDELLTRA disease. of sense aggressive this bring urgency

If made LUMAKRAS this quarter. annualizing accelerating year-over-year million billion. XX% grew We've XX% for price. sales $XXX X% progress Nplate quarter, year-over-year driving KYPROLIS significant to in in volume at higher quarter. quarter. over Nplate third the sales, $X quarter, to to our for and sales And sales XX% execution grew for sales government net $XXX Vectibix X% of now million year-over-year most for $XXX XX% increased the increased selling million the important quarter, brands. by growth performance exclude the we year-over-year to $XX driven third growth million third the and third increased

And to turn it with will portfolio. who disease rare our Vikram, cover over that, I'll

Vikram Karnani

only to Thank on sales provide $XXX delivered in Recall, business. with in growth an to when Beginning eye of currently of compared single QX. TEPEZZA sales there am pleased disease, the third update quarter product are year-over-year patients rare in Horizon $X.X for million, TED you, were reflecting thyroid of the digits. disease, X% and which results billion is I penetration legacy XXX,XXX the Murdo. U.S. roughly treatment from the

activity are have presented XX% score, roughly a CAS. about of clinical or opportunity the the We growth by TED who patients excited lower

focused reflects quarter. recently continue This other high We on have X previously, reorganized and made approach optimized force patients to expanded discussed change an footprint those on and separate more while to teams, specialists have dedicated focused ocular CAS these CAS to we our expanding from reach comprehensive disease our the effectively serve TEPEZZA. and we the low reach patients, can disease one ophthalmologists field patients this with to benefit who in into with and endocrinologists. third As

have last these new potential the weeks, with on actively teams over new prescribers. been relationships few focused And establishing

to treatment expect few reimbursement traction experienced the and enable more We become for identifying this next the patients to to physicians the gain TEPEZZA. as access quarters focus process optimized over right navigating

completed expand quarter, this XXXX. remain its confident cast in the access. marked closely Japan milestone in approval patients we International reach ahead the early filings low continue across to growth with key Following expansion our which potential payers expected work to is launch, or to in multiple remains with TEPEZZA we as progress a X% for TEPEZZA's of opportunity regulatory by a in and our expand year-over-year long-term U.S. with growth key regions. disease September in

option opportunity patients our We and by with subcutaneous QX, growth experience driven the sales and Phase adoption to $XXX XX% also in in patient a see IV commercial year-over-year volume as formulation. an with for delivered increase chronic representing TEPEZZA million strong from alternative an initiated III current to this gout growth improve refractory study execution.

earlier standard established new which this growth. chronic UPLIZNA neuromyelitis UPLIZNA XX% a QX, delivered care launched NMOSD, disorder, in of with in launches Canada, sales representing gout. is markets, year. of expansion has underway or year-over-year for multiple International spectrum immunomodulation $XXX with for also with in patients optica including refractory KRYSTEXXA million

Sales we're which in U.S. patients Additionally, XXX,XXX a the treated patients growth. tapes. ANCA-associated XX,XXX or year-over-year third TAVNEOS growth the $XX to quarter. the in with the vasculitis GMG, data U.S. and of over patients affects potential XXX% increased both X,XXX UPLIZNA by driven the the were Sales million U.S., by been gravis generalized which driven with than more nearly IgGX-related In myasthenia of volume by disease, affects for excited in XX,XXX striking have

in increase far XX% prescriber roughly a TAVNEOS, prescribed base year. now have so the professionals care health X,XXX Over this

we all express this the we're sincere diseases. clear working on how the to of it's past reflect from serve come opportunity far As progressing. my the suffering how to gratitude I to to we've well year, needs patients and take in members tirelessly rare the team that are integration want

about we're confident excited in we'll our business Looking and the and disease beyond. ahead, opportunities what rare in achieve

I'll update. Now our hand R&D for over to it Jay

James Bradner

gravis. Vikram, meratide progress and clinical in significant made positive In afternoon, of and therapies. data Since number or first-in-class II you, good Thank everyone. myasthenia the includes initiated broad advancing practice-changing UPLIZNA a study update, last potentially Phase with type we diabetes quarter, our pipeline, generalized III we of delivered a have X potentially which our best-in-class in Phase third

Additionally, the the this FDA in medicine. Breakthrough important for underscoring IgGX-related Therapy impact granted potential of designation UPLIZNA diseases

Phase also results from evaluating positive reporting medical studies rocatimlumab major at data in III from dermatitis. the IMDELLTRA, conferences, We programs AMG-XXX, and promising first oncology [indiscernible] X several of while showcased atopic including

Let's begin medicine. general with

unmet track II in XXXX. obesity, upon MariTide previously confident II and of obesity-related we diabetes. in remain top are forward chronic XX-week will Phase late important profile the medical seeing to weight study the mentioned, X and from needs in As a the of in line based MariTide address on interim Phase look ongoing analysis type conditions We differentiated MariTide data management, study are

broad planning diabetes. X actively and in to conditions expect are initiate Phase type obesity-related obesity, III and a We program

has This patients Phase monthly type with even in X MariTide quarter, be dedicated with potential we obesity. frequent this MariTide less initiated dosing. II trial to diabetes, or the a living first investigating setting with in without the and therapy

patients. MariTide, Beyond enrolling Phase actively is AMG-XXX I our of trial

incretin also and obesity preclinical programs, injectable mechanisms. oral which both approaches both include We to continue incretin our comprising advance and non

for IMDELLTRA, potentially LP medicine interfering cardiovascular DLLX in studies lines a to Also targeting small Phase fully targeting extensive literally or III with underway trial cell bispecific disease. advancing BITE first-in-class enrolled medicine. engager In of therapy both general lipid in oncology, cell T earlier stage is rapidly small RNA olpasiran, into best-in-class progress. Phase lung molecule, stage and cancer The olpasiran our continues outcomes X is III of

reduced subcutaneous [indiscernible] second experience, enhance line part program, Phase further patient Phase as small with and the extensive-stage a stage Phase To III the cell initiated we follow-up extensive cancer, lung impressive study in IMDELLTRA evaluating a and have of activity we safety monitoring are XXX we in our anticancer later of lung evaluating Delphi or II patients with Ib In September, sustained patients demonstrating cancer. small profile. data presented from cell study manageable protocols

which cancer. a X IMDELLTRA data efficacy We study and small cell cycles Delphi in Ib also platinum-based ongoing chemotherapy. maintenance chemotherapy to extensive-stage similar cell following lung from first-line lung XXX, PD-LX test cancer, combined inhibitor of inhibition is extensive-stage with design of XXX, PD-LX the and presented Phase inhibition versus Delphi alone, III following IMDELLTRA therapy the This study, PD-LX of as first-line Phase small our

median IMDELLTRA overall a follow-up of and With estimated XX%. manageable X.X X-month safety of of progression-free survival a duration of of profile, control median months disease XX months, survival has X.X demonstrated median a months,

from our announce post-taxane a evaluating initiate authorities, castrate-resistant in Moving exploration we dose The regulatory CDX first-in-class will III in Zaloritamig, metastatic Steep following recently by cancer, promise with quarter. in cohort study monotherapy with evidenced patients to X consultation pleased I was CRPC. bispecific Zaloritimig Phase presented molecule, or to data are prostate this of mCRPC, we Phase a September that

was in population. improvement With a months a survival XX.X months potential months, across median XX.X all this follow-up historical of median overall survival of the the cohorts, to median upon patient XX XX

investigation. a randomized and I dose dose from clinical schedule optimization data Phase Additional III for cohort the expansion and recommended identified Phase has

lines earlier therapy we Additionally, prostate in of in earlier stages in zalaridimig are of and studying combination cancer.

X of studies Recently, the we Ib ongoing. study I have combination additional enzalutamide with Phase Our localized in more investigating zalaridomag of in management initiated zalaritamig is abiraterone, and Phase upfront disease.

[indiscernible] therapy cancer. or prior evaluates to that diagnosed, first patients study neoadjuvant high-risk in intermediate newly prostate prostatectomy is The with localized, radical

The definitive in cancer prostate evaluates second hormone-sensitive high-risk after nonmetastatic therapy. study [indiscernible]

excited bispecific the development. particularly about zelaritamig, are third late-stage of engager We cell potential clinical our T entering now

Beyond bemarituzumab, factor gastric our with completed we chemotherapy in directed III our first-in-class IIb of XXX, fibroblast monoclonal nivolumab growth study T first-line of cancer. enrollment engagers, FORTITUDE combined cell have receptor a Phase antibody and

FOLFOXX survival. gastric to read out longer In results which in a the versus the study and study, FIGHT expect progression-free This chemotherapy overall designed FORTITUDE of coming first-line on XXX, successful reported months, II III of we study Phase chemotherapy bemarituzumab Phase cancer. based was combined alone survival numerically with the

PRMTX also recently with non-small oral Lastly, II rapidly cancer. NOL advanced Phase We September, dose previously from profile. XXX, we and MTAP tumors. solid a we in promising demonstrating inhibitor are treated I and cell NOL and AMG patients developed study our escalation advancing study In initial selection. a initiated dose XXX This expansion for lung of for AMG help encouraging activity monotherapy address study, presented safety Phase agency requirements an to acceptable optimization regulatory dose will data MTAP

per counts upon moderate greater Based These TEZSPIRE severe encouraging inflammation. with with collaboration COPD, target planning initiate COPD equal to Phase Phase trials patients cells blood data III eosinophil are in II microliter. Turning XXX with to patients AstraZeneca. or to studies we with to in very will from than

We expect of half to begin enrollment in first XXXX. the

studies expected in Phase also positive atopic polyps, line study from dermatitis. with secondary patients with Phase nasal study we later data TEZSPIRE in of endpoints III and September, in all where met In top Horizon The its eosinophilic this the separate is and chronic co-primary rocatinlumab key esophagitis results investigated are endpoints. announced being III year. of rinusetasitis

anticipate from deepen We understanding additional our data program of readouts the rocatinlumad's will ROCCAT profile.

on serious patients targeting of explore have Beyond as small [indiscernible] studies atopic systemic evidence suffering our CDXX we BLINCYTO Phase rheumatoid asthma inflammatory depletion blinatumomab more in benefit II as studies diseases rocatinlumab dermatitis, approved of nodularis. and aplisma. in and even autoimmune to mounting refractory for from CDXX continue To the arthritis. build investigator-sponsored severe of targeting therapeutic our CDXX expand of moderate sclerosis BiTE directed diseases, in for to prurigo These trials antibody approved therapeutics impact from we inebilizumab, initiated molecule and monoclonal B-cell our

on lupus will to focus initial Our be systemic with with arothematosis indications. plans nephritis into additional expand

generalized placebo-controlled populations. positive to rare autoantibody gravis. potentially a study, setlcholine autoantibody the a the MuSK-positive receptor Shifting largest in We Phase biologic trial positive ACHR disease. evaluated therapy practice-changing recently in and positive or presented UPLIZNA MINT results III MINT muscle-specific from myothenia kinase for both

population At clinically to ACHR MuSK-positive quantitative as observed improvements compared population myasthenia XX living This statistically compared myasthenia well in XX-week separately. and the placebo also score demonstrated significant UPLIZNA each UPLIZNA daily combined as activities combined doses week significant the X of and improvements efficacy the in the gravis the to statistically just reported time populations. was achieved in in at gravis point, score, meaningful after placebo. in

Importantly, to use. corticosteroids Phase and first at starting for taking corticosteroid placebo-controlled a per X-milligram week tapered Mint a myasthenia biologic by in MINT the were that III patients down gravis tapered the trial day week only XX. X is dose study,

without myasthenia aplisma the the and patients with generalized of with efficacy burden for a such, in steroid chance gravis chronic observed meaningful toxicity As offers benefit use.

cohort data has MINT open-label XX-week In to the ACHR and ACHR from UPLIZNA forward where period results populations. to study, and efficacy. patient of positive look the demonstrate durable the positive potential both for We MuSK-positive the

III upon Based in College generalized the UPLIZNA beyond for in diseases, November. data of August, treatment Phase designation the or Breakthrough the presented study. Conference Rheumatology This at myasthenia will GI-related data gravis American be of from Therapy disease. granted MITIGATE FDA Moving the IgGX-related immunoglobulin

both of in gravis and these regulatory the We and with disease UPLIZNA encouraged authorities. are working actively extremely to file by are IgGX-related myasthenia data potential

In commitment this closing, for their focus facing want to patients I grievous to for illnesses collaboration the Amgen the year. productive colleagues thank during my unwavering for

I'll to now update. turn financial the for it Peter over

Peter Griffith

track our with strong quarter We're XXXX and Thank and on you, with third year Jay. are objectives. our pleased performance full goals long-term

innovative with with around of in-market strong including serving areas, across illnesses therapeutic and a globe. long-term each growth have and X our products, the patients depth serious We our outlook breadth pipeline

our innovation to on continue a $X.X will slide other Starting priorities. to quarter in the flows, also results allocation shown capital third to strong allocate as and our we fund revenues, capital increase. Slide XX of We with deck, cash first with our total billion intend XX% year-over-year delivered

of Excluding of increased Horizon, year-over-year, the the addition volume the sales quarter, deductions. X% the quarter a with XX.X% estimated sales by we the sales changes U.S., driven of $XXX million growth. largely as in product addition were third of impacted operating percentage year-over-year, sales by total by margin non-GAAP driven non-GAAP to unfavorable our increasing In Horizon. operating delivered and In XX% XX% expenses product a

quarter invested late-stage Non-GAAP programs. spending SG&A as the to relatively addition expenses meratide, excluding R&D XX% Horizon and in of as increased expenses Non-GAAP advancing in $X.X well XX% Horizon, addition pipeline of as SG&A rapidly acquired we the the non-GAAP third Horizon, driven the year-over-year primarily year-over-year. year-over-year, opasiran flat were bemarituzumab including by billion increased

EPS to to as the year. The we year-to-date, progressing the be is than XX% cost integration of to to million and and be acquisition we $XXX Horizon synergies end by The it realized year by expect year X well. with is non-GAAP reach more pretax accretive this acquisition full for post well, in expect

almost capital and debt we to to to up $XXX the million our Horizon expect Our non-GAAP sheet end $X.X by resulted in third of retired million acquisition, balance our from due increased billion acquisition the quarter XXXX. in expense return pre-Horizon the a year-over-year, structure interest to expense, with of continue strengthen OI&E entirely $XXX

to Our the due the of $X.X of billion non-GAAP year-over-year the of free previous XXXX, tax an generated the rate billion earnings decreased In of company third year. from X.X XX.X%, Horizon. the mix change from $X.X to increase percentage points cash flow, primarily quarter in inclusion

advancing including facilities. our investing and state-of-the-art cash strong for manufacturing exciting Our growth, and capacity in our business pipeline flows processes long-term our opportunities enable in expanding

to patients enable significant investments past Our us of number serve a today.

over Miratide with other ongoing Repatha the will for expected products example, support and For million investments Prolia XX units portfolio. and future in and XXXX, alone across

X% competitive we dividend the second XXXX. represented returned increase as In paid to in shareholders compared of quarter. capital addition, share $X.XX to we per This a

business Let's the the outlook XXXX Slide for on turn to XX. for

$XX. to in pipeline expect is EPS historical the increases QX and EPS We our including innovative assets with of $XX.X lower We expect in revenues our EPS, and to strategic total trends. than our $XX.X to billion consistent meritide range key UPAZIRAN because XXXX QX non-GAAP billion between pattern beginning non-GAAP be do $XX.XX This business, other in planned business with of investments. investment sequential in non-GAAP

approximately as a mention We year you full million now at sales consideration model revenue few the billion. Let approximately new asset remainder other XXXX. project $X.X and me of at $XXX

TEPEZZA expect of being prior in full slightly we X% QX operating sales momentum be expenses year to in resulting quarter. the XXXX, full and with in be drive We in sales the like the our year sales This quarter, QX of year brands in approximately flat as year third additional example, fourth Repatha to into for compared expect highest investments years, Consistent of the down expect to to XXXX. EVENITY. year-over-year includes TEPEZZA up to be versus XX% the full operating key and expenses to roughly non-GAAP

of We non-GAAP still expense We than approximately year-over-year, full addition total which now to to $X.X related debt $XX Horizon XX% acquisition. of the the million interest the raised Horizon. to For from year billion be year-over-year. full for expected the approximately expect includes our $X.X billion, OI&E are non-GAAP including expenses of R&D XX% more the operating year, expect growth grow to

to and the year process. quarter with benefits We to full the the in business XX% including Horizon in to rate provision the tax non-GAAP items the range, of in return inclusion now associated XX% identified be favorable expect the the

$X.X expenditure our guidance Finally, capital for billion XXXX. at remains

our colleagues to financial dedication worldwide grateful our outlook patients. remains growth This Our serving for strong to and update. I'm concludes their long-term

now Bob for session. our it back hand I'll Q&A to

Operator

from question first Our from Goldman Richter Instructions] Sachs. [Operator comes Salveen

Salveen Richter

The key Can the help other with III year-end. update data from what time obesity remains Phase developmental actual also program? the in II to update we when Phase you plan Mirati you an terms and this and regard data might of lines will the update share understand into clearly get and us

Robert Bradway

sounded like questions It a Okay. few Salveen. there,

As in expecting to that diabetes. very The we we prospects said, the is we're have we end we'll continuing continuing those type the and be the well, by study with and that the to when added here of on progress Mirati, we're call the trial year. for to being X data the obviously Phase excited disclosure to investors. to our this II we about begun data, conduct of the forward And have able have share look

Justin Claeys

to please. next Julian's question, the go

Operator

question Olivia from Cantor Fitzgerald. comes from next Our Brayer

Olivia Brayer

to You III program. kicking a are off lot getting closer a marati Phase

do clarify in-house? or of that data you hoping how into seen you kind So think have II can you [indiscernible] those about spend whether of the not will level Also go Phase that

Robert Bradway

to of view like safety its and profile. will III you III our invite obviously, look are and add full we you'd type program. trial, characterization molecule. fully exploring is So the large diabetes. the pursue would broad molecule, III expecting a a our a It conditions be, that reflect obesity-related to we And and trial with we differentiated about global will X Phase forward trial, respect color this expect Jay, Phase the to to having efficacy we I'd would reiterate investment any But the that Phase

James Bradner

on diabetes, fully in progressing the will Thanks, and a Yes. dose characterize tolerability heard expect III include Phase II broad already, In Phase efficacy planning to as you've to we're Bob. track patients. response, initiate study conditions. This obesity, program. type actively obesity-related X We're

without obesity diabetes. Importantly, X having but type

planning on actively So fully we're program. track, the broad

Robert Bradway

on the normal And as front. then for part then updated the I'm coming helpful also expenditure reflects give an we'll process we'll perspective -- capital III may be Phase year, that perspective we'll And guidance our any that sure of add trial. in the our plans

what think molecule just that configured. fits antibody with network you our I remind currently this well on would is I It as is designed platform. very our existing

say we'll through as again, about more time so And that have to necessary.

Peter Griffith

Peter development. yield remind Maybe Bob here. manufacturing would to I Olivia, just of terms and -- that going we process might of science being in the leader Amgen's how forward. creates long history suggest, view it's opportunities a in and of you

mortar got might steel, important, in we've and really and strong a yield So really is while bricks, it that. be not history just

raise that guide year. we year, spend quarter-over-quarter $X.X very me know, you about that. CapEx and up the mention did prior as And the XX% this to billion. you heard to And development thoughtful research about We're also

XX% year. We expect it for to be up the over

be So we certainly public right are to we we front to investing forward we key a and the of is where innovation and at player always in Mirati say will investing look in that, this global health crisis.

Justin Claeys

please. let the question, next take Julliane,

Operator

from comes Jefferies. Michael question from next Our Yee

Michael Yee

quite confident have other Can also Phase greater are you far and don't but are about so. -- given you with the it the I guys about I portfolio so the announced things late And XXX XXX. also else yet you building portfolio you believe comment oral, you to everybody like so have early, sounds a the whether who has so the believe stage? competitive many be totality MariTide, don't is you of and III, an portfolio things in are Jay, for you think just your Maybe yet today at

James Bradner

of the as The Mike. Phase I question. fully clinically interesting III which and up focused with program. as the really disclosed this setting program. action now We've for on Thanks, data you broad pleased conditions the study obesity preclinically very await with obesity-related a of of the we're mentioned. active XXX really mechanism execution is year, is here, MariTide, a additional investigation medicines the development really source nicely not later yet shared of With of XXX, and appreciate

on is as well reflects announced been with are non-injectable enrolling serve like the is smaller clinicaltrials.gov, injectable and very this non oral patients it's administration. as obesity pathway and SAD/MAD landscape well intravenous We're feature these. of others, many and action, and obesity the pathway We, note, our incretin segments interested to has subcutaneous within study dose all you portfolio reach as And other related of ascending the To creating interested mechanisms in conditions. as in both as medicines. segments, each

Justin Claeys

next Julliane question, please.

Operator

comes next Courtney question from Bernstein. Breen Our from

Courtney Breen

final Just that context expectations the the in on and QX provide when for team conversations particularly terms the of TEPEZZA. anchoring QX. impact of comments products please Can of see expect around some and the sales context specifically shared you to path the there, to shared on to the in you some you relative more of that the growth Horizon we

Robert Bradway

Yes.

it in couple a take pieces. Let's of

heard First, the also of remind then general? X%. Vikram Japan expanding . or plans the and Salesforce our more investors as to grew speak you for us quarter perhaps say, international just

Vikram Karnani

Bob. Thanks, Yes.

patients, just to -- So patients I ocular the from to dedicated from that in effort over comprehensive disease. time ophthalmologists we need is not in year-over-year. as X% as high reach said have most XX,XXX as And order as prepared low serving as and and towards previously, these TEPEZZA to only we our spec effectively roughly prescribers grew we that we're these low also both have CAS focus cast growth said XX,XXX continuing patients, these remarks, also Bob endocrinologists. but my said cash What well a learned the and have on coming patients suffer

approach to appropriate find TEPEZZA, physicians approach new TEPEZZA prescribers the type the right order previously. to discussed what low right disease that that to allow an for cast We only And way. serve patients help of in reflects but and not patients we or so necessary enable this is us access the that also most we This the optimized to help XX,XXX found is footprint. have have believe coverage will

would this bit on here. here occurred we've has I this little is working been been we say something for Finally, that is what in quarter. the -- a third -- And change

So updating we we do have prescribers, last expect these new with out weeks, the few look quarters. momentum relationships on to and as actively in next the here go. play to In establishing you the teams several focused new the we been forward

the point TEPEZZA. Final global aspects on of

a we really our the also important to looking Japan. the including country As to beyond terms of patients us launch. is around for U.S., you're in TEPEZZA aware, globe, bringing to next Japan are forward

for you to TEPEZZA early that launch in there received well. we Let we're and as CAS patients XXXX approval working me actively high September, with Japan in remind an

Operator

comes Raffat question Our from next Umer ISI. Evercore from

Umer Raffat

I in secondly, not which fairly first, expect addressed Phase I recall in of the weight itself I incorporated consistent one. plateau That's profile any on and may. And had may I'm between vomiting reason low super there number wasn't could then not I the other have month loss, vomiting. we've of X specifically I, there perhaps if the a anything curious, imply in in a on the of was that and that for in which from itration. generally not X-part vomiting But high Jay, doses, to kind of vomiting. seen the cadence important -- is solve titration Phase Phase in so to is post perspective, do I months GLIVtrials weight happen loss design because would do that before or happen trial, past question Perhaps, X MariTide, to profile X

James Bradner

Yes. a really did was -- Antisedan study pretty January appreciate study The considered escalation titration. Phase Phase Thanks, has thoroughly standard now Umer. this published dose in been that have I I it. not I dose

only focused Phase I the learned these much suppose that there's saw we're at I So the planning. question, answers as II know, where we're differentiated data, can if honestly we from just And the Phase profile. III interim, your that you in on be so really Phase

from will Regarding interesting data, the an learn plateau, which wait thing loss and later weight this year. we be observe to this

Operator

question Jay next from from Olson Our comes Oppenheimer.

Jay Olson

Congrats progress especially and for to Maybe the BLINCYTO. impressive I'll on Congrats gears growth, on all shift oncology. quarter. the

to there next Can For registrational have going may what the half year. on now you in talk for second it like of about the initiate the subcu changed study? plans and some looks is that share study BLINCYTO, maybe color

James Bradner

This us. Jay. of Jay. a Thanks, subcutaneous seen encouraged is site the we've Yes. major priority prior We're very is in by subcutaneous that BLINCYTO studies. X efficacy development for The with

XX X times did a within evaluable saw XX% in CR dosed You'll Phase We at ASH I cycle. patients, remember among we week. medicine XXXX a data, back study perhaps this with striking is rate X that

further And MRD all XX negative. is whom an Journal of CR There's since XX% time, the rate, data been patients Hematology CRS. without were for this American XX% grade any of that with in

you excellent us. investigation. in timing for It that clinical priority major really read a was to is BLINCYTO into in subcutaneous to nothing the question. So allude your progressing there's And

Operator

Our Stanley. next from Morgan Flynn Terence question comes from

Terence Flynn

Two part on Mirati as well.

you data if disclosure wondering be Just will confirm the conference. can it will if be a or release press at a

I conference at presented December. in insulin think resistance were data the I Phase the

the Phase to could schedule to their any going in here? necessary II from that move be something you're So I Phase Phase schedule Jay, think the know titration to the extended that's II? titration they just you have to employed you you then had III, Do tirzepatide make changes Lilly when Phase wondering for do III. And venue.

Robert Bradway

that we and In share hand the we'll with terms focused to do we're in Well, how when we on in the have interest again, data investors. getting whatever of try of best shareholders. the Terence and release, them,

III? report question being you address tuned as we stay Phase able on have them. And soon So look those. want to do as to the to We forward Jay,

James Bradner

we've The Phase III and out approach that we dosing, news but fully well any insights feel the planning, II later or as won't our informed be Phase study is is into will it and ongoing, we'll give on today this confident read track, to year. by we shared,

Operator

comes question Our from Carter next Gould Barclays. from

Carter L. Gould

bit a it maybe gone I little launch. you switch have others so. have want a little and Path to biosimilars ask well, really the Blue bit up Amgen around some less

and adoption of entrants? with historically ahead code other newer the You've how about biosimilars discussions edits of in any -- or for do about payers, you step of your some but a think ahead Q expectation talked

Robert Bradway

get talk share often the why chance a general Path Yes. but don't We to on Murdo, please franchise. you Thanks, thoughts your Carter. Blue. it, about also biosimilar don't on in

Murdo Gordon

but this next Bob. as Q in codes we much of in to biosimilar that launches obviously this Carter, on position the as are [indiscernible]. expect as Pat not-too-distant having in interest out And wave And a opening clearly, be it's wave. product our you strong mentioned, the we excited may given have in of important, quite my about as important in lot pretty we're now the we On we Pad as biosimilar Obviously, speak. there's that not flu, I early permanent expecting reimbursement it's future, launch case, interest there with but in Thanks, the pad Blue, mentioned Blue to We're even there in launching remarks, phase. -- launch we're are a first code. temporary is other just be or that first

Robert Bradway

biosimilar we think franchise that and earning our it's is we've generally, shareholders. for industry-leading well, as a And Carter, It's returns franchise. what is built think we very performing attractive

Operator

Our next question comes from from Schott Chris JPMorgan.

Christopher Schott

program commercially market seems It interesting fitting you. a just coming the you really TEZPIRE little was in quick how the might some data. II on how interested Obviously, some but you're question nice earlier data of about landscape is a DUPIXENT IL-XX consider just both we as to here COPD. seeing But Just like about a landscape? me help ahead you have year, broader this think bit Phase of and potentially into potential that just the

Peter Griffith

Murdo don't why off start I hand Jay Chris, you. Well, is this and to and

out we compelling broader patient And This They to II against were here numerically knows that. we're period And AstraZeneca. The a were exacerbation recently, XX-week you chance COPD. than a moderate So patients Murda a population on of antibody very positive monoclonal these severe a that invite our TSLP rate having reduced -- developing study very read in The to even TEZPIRE, reflect time. data XXX a triple And by study. to as had with Phase exacerbations quite all over have placebo is with therapy. XX%. despite we [indiscernible] perhaps actually went head-to-head

stand subsets we're biomarker announce to that most. these with which And to benefit vlodiasinophils we're of learnings, now the planning We learned to III TEZPIRE a posture? studies This as Phase structured lot from to efficacy pleased studies of patients, around set AstraZeneca. initiate pre-planned bit our reflect Murdo, with a well to like you up and would together And the competitive definitively about answer COPD. question little is trial to all in

Murdo Gordon

to in the when Thanks it so new-to-brand comes obviously in question, actually with now the asthma. performance uncontrolled pleased of severe Chris. product really Yes. second category. for that uncontrolled We're far the prescriptions prescribed TEZPIRE most We're

So that, broader differentiated I the hopeful and there. population TEZPIRE. and the that COPD to And clear think we as feel of immuno in mechanism and of upstream in differentiation out has mechanism in that unique a Jay the is profile action that, allergists address continue it to it's unique appreciate compete about ability of now also patients and believe, good that pulmonologists and that which way the we intervenes will we're action that the of cascade, highlighted to opportunity really the inflammation play because

we same voice of strong voice resources we combined and the Phase Amgen, of able very III our on AstraZeneca expect affect to the currently have to With the be asthma, in trial. a completion at of share that severe of strong partners share uncontrolled and successful

Operator

from Evan Capital from comes BMO question next Seigerman Markets. Our

Evan Seigerman

you offer launch talk branded or a use specifically, can on you some practices? about extended these biosimilar rebates to colo touch how would invoicing the demand to biosimilar. Are want able for strategy more and for launch otherwise the of the Maybe product. I Ophtalmologists stimulate among who

Murdo Gordon

what Thanks not doing will going key for have I the respect commercially I'm a to we broad the force field that with say customers Obviously, deployed we're about contracting. covering question. we're very therapeutic this to just in talk area.

covers strong population in excited very networks here. the the biosimilar the we're and percentage that launch, institutional organization isn't market. receptivity been large to been the and have a We we've purchasing high. first large effectively, be has This preparing groups that And our the treat and of

Operator

Fargo. question Wells comes Mohit from next Bansal from Our

Mohit Bansal

Maybe on question the a quarter. for Congrats Jay.

about too trial trial, a point? obesity to with AXC of do into that would II this ongoing given at be the conclusion have just Phase you look you So you the able well? drug it to that any patients is profile small the think in Or make diabetes as

Murdo Gordon

Yes. Thank Mohit. you,

you and with know, overweight. runs As type with regrettably obesity X diabetes

study, insights do in the expect II some experience -- need we but dedicated Phase from in a hope activity in have so to Phase And into study and anti-diabetic we II obesity. of without an diabetes, patients particular, to have diabetic

towards follow year. this later So there more to

Operator

Cowen. TD from Yaron Werber from Our comes question next

Yaron Werber

back. year? XX,XXX biosimilar just the ordering just And now? about relating one-timers you. this is then to you're there on Murdo, a normal is particular purpose upcoming QX XGEVA, quarter mentioned year. questions I late that see next couple the versus accounts normal expect secondly, in the of you May mentioning Can talk what XX,XXX accounts a maybe launches dynamic next that of new got I you Enbrel, Prolia on Or for quarter? we One, didn't in Prolia. bounce any to just was this -- presume that maybe is

Murdo Gordon

you quarter. which in course, for the in X decline impacted regular as a one, up, adjustment picked of negative quarter. was Thanks the trends the and was price another net then Yaron. the One, by XX% in question, Enbrel Yes,

softer So the quarter normally Volume was the is you a quarter. than X% little in see. up

this treated do net well breadth terms look with patients in have to an XX,XXX This we are . When price Enbrel to declines So utility of Prolia the treating of is but important this going we of forward. so we continued I continues having expecting and product. far that prescribers provider quite accounts give just at patients idea mentioned Prolia, year.

an important strong potential patients for way to we in. continue to growth very that enjoy source Prolia for with thing The see us other we which EVENITY, it's is

reduce we could their feel something in bone of So in And our risk treat competition of presence the and treating face yes, future. in the end women it physician us who up the in population to despite presence of that of becoming the their market about many really good trying it. osteoporosis, community effect biosimilar that fracture are the helps the terms

Operator

Capital Markets. from next RBC Our from Gregory question comes Renza

Gregory Renza

to on comes mentioned Bob, you've space. what Amgen's maybe replenishment in -- in Certainly, this mentioned pipeline IPF. certainly rare And disease just being discontinuation always franchise. And pillar? approach that, the different it at when [indiscernible] is the a approach to looking Parents the we've disease rare it's

rare your about about specific to in disease think marketed disease also how the and disease how supporting following franchise. areas Just you how in think and rare current kind of curious products

Robert Bradway

the to a rare that We what respect With about to the we disease can this on think are we're pieces. obviously in excited And couple bring very And of is attributes a value we of molecules the over to them, and this or know, each time. lot Yes. diseases take of field. stage we life that cycle. we involve early as molecular add you in and market, already think can of either an

think excited markets. we can we international what we're with those domestically So in about do and

And insights how frankly, to existing potentially resource, as we're molecules in excited about, both our portfolio the enabled which also has you're genetics glean us familiar well from disease with as rare invite I'd our able topic this might be we to of to rare But with brought a Jay to that to energy others already it. share thoughts. add disease lot his organization. He's

So Jay, fire away.

James Bradner

of for and staff for Horizon question. really our thanks R&D. acquisition The Bob, and the Thanks, Gregory has energized activated in

had Horizon. mechanistic by we've world disease the of and of colleagues, I the new around activated expertly of the to R&D multiple acquisition really for capacity think rare inspired imagination launches our repositioning TEPEZZA patients project the medicines to a eye since thyroid has bring disease, the

integration disease the ideas. I And smoothly. staff rare also seamlessly acquisition the of joined the lot would have priorities really the and say for gone a us brought have the Second, through very portfolio has Horizon executed both who've interesting that development

dedicated with initiative disease rare a now leadership. have We

space. to for this leadership rare innovation We hope have And drug in the disease expect just in development. external and we was dedicated continue that Horizon really known best-in-class

in and mid- So the a of the innovation internal think, early-stage more than external blend disease and to come. years replenish will, rare I pipeline

Robert Bradway

the us particularly and also that We're side. about excited joined the the on research from medical talent Horizon, very

for feel we equipped now this patients. to well difference continue really a area make to and in So invest

Justin Claeys

Great.

So X more as we'll questions. maybe hour here, take half the to getting we're Julian,

Operator

from from Matt Our Blair. next question William comes Phipps

Matthew Phipps

current Phase the going size? that's trial? I separate believe if Will COPD single be thing And they into it's mg that the identical dose into formulate that a design? to confirm, given in to trials. XXX taken is just is is twice, can injection III this Confirm then be you forward the And X

James Bradner

consideration come. today. that with full that of of Phase soon Matt, program in They're III colleagues have will the Together and Yes, a but questions, AstraZeneca, COPD here address chance to the can our support we'll for none describe to question. from thanks good the we design the TEZSPIRE

Justin Claeys

All right, Julian.

time have more. we think one I for

Operator

last Piper Sandler. Chris from from question come Our today Raymond will

Christopher Raymond

for supply a Blue. launch. least curious, feedback an just supply back provide gotten doc I on kind one with to think, on Just of Maybe has maybe as And the to Avastin development, of this U.S. new of you amount suppliers market, this thing We've drug some seems at talk market been option. but Avastin, at Pad more which decent guess, interesting market does terms very this on role be issue about this predominantly actually the even one option may guys? vast how you this in bill recent at of disruption receptivity more in that's make a a I opening to to that a the you provide to line, of the least at biosimilars fading inexpensive went bottom buy and this in with interesting looked looked

Murdo Gordon

you we we have capability. Amgen, and are treating your and world-class say of staff here reliable Thanks for highly have supply to very you at that manufacturing the the provider, get used question, product want as reliable Chris. But supply you first and chain I obviously, foremost, a when a to you're handling. fortunate -- manufacturing to continue to serious want a illness, And and have to have can

shortages Avastin. from benefited biosimilars We other have including with

we you, MVASI, biosimilar product. have our own that remind I'll As to

Amgen here to manufacturing are very some able putting that the providers the communicate to who in again, seeing world. and in ability are patients for about us customers time. to we here the for colleagues position around U.S. reliability obviously individual of to the be and a given supply And strong us with speak institutional shortages I'm So to to and coming thankful us over customers our at

being own with here said, That think Pad looking at opportunity the in I market our definitely we're Blue.

for that that manufacturer, to to is interest customers. if going high you think we're over going in that talked that want the that. well and sophisticated understand mentioned They customers retina go are they're you've believe they're These we relationship specialists time, there's I a to. positioned with a persistent

prefilled device a We syringe. great have a in

vials. have also We

demand to that's establishing And that's But what market. field teams are the what do, this in supply to this our right able So we we're thanks in and your for now. intend interest.

Justin Claeys

Julianna, team and will If were your questions, for and all Justin for any joining get chance didn't few his Okay, you for more hours. ask thanks moderating of to thank us. there still our you who call, be a around a

So we next we look forward to information. much. Thank Bye-bye. you when very you gathering relevant have with

Operator

concludes our XXXX earnings QX This call.

may now You disconnect.

Amgen (AMGN) 30 Oct 242024 Q3 Earnings call transcript