Eli Lilly and (LLY) 1 Nov 222022 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2022 Earnings Conference Call. [Operator Instructions]. And as a reminder, your conference is being recorded. I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

good and Lois, you, morning. Thank joining Thank Company's Eli and for XXXX you Earnings for QX Call. Lilly us I'm Joe Fletcher, Senior Vice President of Investor Relations. on Anat Officer; And Chair me today's Dave are joining Ricks, and CEO; Ashkenazi, Dr. Financial Chief call Lilly's Dan Lilly Van of President Neuroscience; President Anne Jonsson, Lilly Diabetes; of CEO of Scientific U.S.A. Loxo@Lilly; Skovronsky, Immunology International; President Ilya President Jake and of and Lilly Chief Lilly Officer; White, Medical of Naarden, Yuffa, and Mike Lilly Mason, Patrik Sprengnether, Kento Investor Mike and Lauren We're the by also Ueha Zierke of Relations joined team.

on projections During current this anticipate we conference call, and making forward-looking statements based expectations. our

actual X. to several Our factors, Slide materially on listed could results differ including due those

concerning and our products is of It and information Forms prescribing information to XX-Q the about that our Exchange results sufficient we filed community. intended provide and not actual differ and contained to the with the Commission. subsequent Additional X-K materially for benefit is investment The be not for promotional Securities could latest factors decisions. and cause in Form is pipeline is XX-K

our transition that remarks, we to focus measures. will please our non-GAAP note prepared on As financial commentary

Now Dave. I'll to the turn call over

thanks, Well, Joe.

three to strategy. continued months, last successfully our execute the Over we

of X new expansion where continued of even gene for for in obesity Mounjaro, has for to Fast outcomes, disease. of uptick. pleased Track that launches improve MMO, obesity need On and of FDA our are with a mid-XXXX. tirzepatide an SURMOUNT seen In TRAILBLAZER-ALZ of pipeline line Lilly obesity. launches, we this adults on year potential initiating demand data. our prepare towards time, our enabling morbidity promising III for new modalities also invest to late-phase volume-based early-stage continues future patients potentially next work progressing I'd for the manufacturing unmet drove is We're while our us Phase Alzheimer's medicines, we footprint. high III including to X we the to with growing disease, by accelerated same pipeline to top also commercial the initial strong continue Phase Xstudy an which At outcomes also towards recently granted bring front, have investing growth patient products end new sooner. patients to the and therapy. mortality has progressing to highlight based launched impressive And our To in the advanced FDA dunenumab our TRAILBLAZER-ALZ medicines readout approval and evaluate medicines study like In our areas progress meet and we and obesity, with designation we improved for obesity, medicine Alzheimer's our pursue in to the

and completed both U.S. also We dermatitis for lebrikizumab the our of submissions completion announced in pertibrutinib, in donanemab, EU. mirikizumab. the With for already atopic submission

We by and between XXXX. medicines X of are excited the now new the potential launch to end

rates experiencing We and rate Lilly X new for launches our of product are unprecedented industry. the impressive most of an in undoubtedly

Trulicity. adoption [indiscernible] medicines, product and of anchor encouraged Mounjaro now volume XX% our like marketed see youth grew a XX% revenue deliverables robust and Key X. core constant of of Worldwide Jardiance grew a growth portfolio. continued X% the our on our strategic to QX revenue, in account Taltz, Turning We're our XX%. the currency. business and to reflection Verzenio, Slide global product including of durability and grew for products

same XX% margin is Our in last with line year. non-GAAP period gross in QX, which was the

a of XX.X%, which was and milestone margin points development approximately XX R&D includes operating non-GAAP negative to acquired Our attributed basis impact in-process charges.

This And patients company. FDA for type severe and by finally, with Diversity, and agenda our cancer. are or Fast non-small mid-XXXX; acquisition medicine in important updates. approval moderate earnings approval loss. in at in acquisition promise ESG lebrikizumab Mounjaro announced dermatitis; region for for of advanced like than nearly a living Steve adults we fusion-positive events demonstrates Executive completion EU Human for locally see you'll U.S. with will FDA employer following in to later list improve call, with since commitment equity submission QX call, treatment accelerated our announced therapies and leading for playing Dan key of but to a and have more Japan QX obesity, a traditional diabetes; of rolling several We and disabling including Retevmo shareholders. which thank shared aims the tumor antibody hearing fusion-positive regardless tirzepatide advancing On solid of this of X dividends in years metastatic we Fry, continued RET upcoming and of to our in $XXX for role our Slide that distributed Akros, updates metastatic XX retirement for For efforts adults diversity, premier to our inclusion for with sector. and approval and several submission the Resources our to Steve with advanced hearing efforts accelerate detail our atopic in our cell important personnel, to of RET Vice type or genetic earnings X, our gene to lung excited I'd more advancing pipeline President the expected since discuss and we adults COVID-XX Track designation our EU of milestones, restore, tumors be preserve the to Lilly. key at including and million

providers will track to the beptilizumab. beptilizumab objectives other and results. $XXX financially through the government approximately regards projects vital September range to XXX,XXX anticipating right government be issuance strong we this certain also program. patients sustainability should deliver any further for available across to to inaugural report, distributor. that replacement our These is At of not a -- U.S. doses began teams for years sustainability time, and August, a vulnerable Eric states, Lilly bond experience With the Lilly or sole hospitals of record antibody QX, In has approximately product to our an strategy, U.S. XXX at COVID-XX XX ESG XX,XXX, our shipped the I'm 'XX. I bond achieve make growth impressive We impact Eric for are we who efforts, of a and to Dozier, we is additional million he to people In the in of published through since for used which business ambitious of of orders succeed a are progress ahead. sustainability nearly the developing of our for and allocation allocation people our confident welcome highlighting say, beptilizumab Steve. leader million. EUR purchase we

For information and Lilly the can our about many visit program, you ESG more other website. this of aspects our ESG

more call Anat for a QX review over the turn our I'll to results. Now detailed of

Dave. Thanks,

updates and impact future to Before acquired for to for this provide for expect on SEC from clarity quarterly X-K how Investor and our I we QX. QX, quarters, website. development in communicate charges. IPR&D acquired charges development milestone we provide mid-October, a Relations investors to review In we milestone generally on financial the results the In information with IPR&D our highlight an expect let me earlier change filed the

non-GAAP XXXX summarizes performance I'll and notable items A on comparisons Slide year-over-year X in in QX. Now of moving third overall quarter to financial the comments focus my few performance. affected results. our

includes the exchange administrative acquired expenses of increased to as foreign was recognized foreign logistics Gross which and Olumiant for IPR&D favorable from basis. to lower by and income operating antibodies had impact XXX of full on and We due points. or for X% in Mounjaro sales When COVID-XX rates a X% partially was point offset the development selling marketing, exchange business. R&D primarily of and flat to by basis acquired solid revenue primarily administrative points treatment expiry; expenses by as of increased growth product a which currency, in to development and mix, development the our antibodies. for realized X%, the operating inflation by favorable COVID-XX results. expense on lower currency expenses the quarter. impacted a or X% expenses now quarter offset with favorable decrease XX.X%, largely higher expenses Fed sell increased increased associated quarter year-over-year, Marketing, impact negative IPR&D of Growth COVID-XX, a sales Foreign for of revenue the higher development favorable constant exchange and and R&D roughly of Olumiant grew and late-stage X% rates in this by agreement of a nearly increased related Japan; exchange QX, rights gross were increased treatment COVID-XX for and income rates. the and and percent assets, by rates. we QX experienced the in EU, charges highlighting higher basis offset expenses $XX the revenue margin impact prices collaboration charges. constant Alimta's impact roughly for attributable the sales of milestone basis revenue distribute margin grew partially expenses for sales impact were of due Mounjaro, by treatment the XX milestone expense Total and of U.S. costs revenue quarter increase impact the X%, driven impact to lower driven in the first reduced patent is of COVID-XX that impact off XXX of cost for of momentum of lower our across partially including core the the of approximately foreign offset the U.S., COVID-XX expenses. XX% by by Operating Japan selling the Operating in Alimta, the and Olumiant revenue and launch this X% antibodies offset operating million excluding

last volume tax approximately per of we QX and IPR&D to growth. tax $X.XX increased XXX quantify charge $X.XX compared decrease same XXXX. the share the X, in and XXXX driven in XX% Our Slide XXXX effect period effective by development to implementation and bottom points revenue the basis to decrease rate earnings period Acquired Tax milestone per impact On year. of related share. rate negative to primarily of this favorable a in same This on was price, $X.XX Act. a line, the was compared of the the the quarter XX.X%, impact At QX

exchange against revenue related U.S. the decreased weakening euro the to of foreign dollar, quarter, the primarily by X%. This movements

geography. Moving performance key to by our

This quarter, U.S. volume of revenue grew XX% XX%. growth driven by

due Excluding for by by to net a segment of and price U.S. the COVID-XX, Humalog XX% Alimta, in price insulin the volume reduction primarily driven growth Lispro antibodies the driven partially of key U.S. and decline injection. primarily Olumiant treatment offset for realized increased list mix products. revenue by COVID-XX was from revenue prices growth lower for X%,

Europe. Moving primarily to Trulicity, currency, Revenue growth grew Verzenio by constant volume in and driven XX% Taltz. Jardiance, for

by momentum continued comparison. period in for encouraged expect are in Alimta, as Europe and expiry from June XXXX, the of the our business received patent We impact base the lost exclusively from which growth

QX of in June X% both the revenue revenue the declines in rights currency. by and related medicine entry products, a which for agreement Japan, newer than impact in continued by distribute Mounjaro For Alimta, more generic decreased off-patent collaboration Cymbalta to and of face primarily growth our constant Japan in XXXX. was sales offset The to and sell

currency We're In for impact a DLXs. be of competitors Japan impact to also the continue with in of NR we products COVID seeing as to revenue beginning increased patent our key the growth return constant measures. from subsides. scale expect Zero growth policy to in in declined XX% expiration we and XXXX pressures the by China, Tyvyt local impacted We competitive as continue

the In of of the first addition, Humalog. we procurement experienced full impact pricing quarter for volume-based

this should decreased expect patterns. believe we of a buying Revenue year-to-date in innovative of in customer to growth currency net in rest by growth the of QX, our currency more world primarily level in we volume representative access in accelerate driven X% is to portfolio, in maintain X% region the for the constant drive future. The trends. As high underlying our constant

quarter X, XX continue highlights products to robust this growth performance future percentage products As product. key continue growth outlook. growth. volume contribution a current points the and of XX our drive and Slide growth Slide our key waterwide of These drove further underpin on approximately shown to volume

of class Taltz grew XX% Verzenio, currency, generated revenue. in constant brands XX% these in and our continue Jardiance have and quarter, in to injectable billion classes. see opportunity new-to-brand growth Products up This outpaced dermatology XX% $X.X growth. we are sales within in business further or competitors core made market share for significant and their like leaders In market, of incretin the respective

most to To existing these the we to in will demand markets. intermittent launch plan, in this on patients, may we're those our experience date, competitive on supply volume wholesalers Mounjaro has focused incretin strong hard we In script challenge of restocking U.S., production manufacturing performance. robust. experience to market international Trulicity demand and the globally. expanding patients to limited not continued And of situations, ahead addition demand availability due In sustaining impact our markets ongoing Trulicity, to Trulicity. U.S., of minimize capacity, internal ability is growth initiate successful remain orders. partially our an communication delays working new including while In build more GLP-X, Trulicity to remains to Strong meet for continues to in

in X launch. naive to starts diabetes and than with injectable Trulicity. We're XX. the X XX% class incretin Mounjaro Mounjaro's the type Slide for XX% patients to Approximately the new of first of therapy rapid since uptake from months switches are Moving less pleased

we peer increase. access, progressing of paid should the and And D total are and commercial approximately to as the lives. expand Part have We of to more proportion of negotiations start XX% access script than level doubled

to intend may for supply ensure impact is available to to Mounjaro make and patients. actions for negatively X take volume, impact expected These designed we diabetes actions and type revenue. focus but Our patients, prescription not net are access these to

competitor's Lilly's supply. demand extensions expect unprecedented capacity. in incretin bolstered efficacy X incretin In a growing experience. Slide type result this We and we key capacity assess RTP North and and customer we have demand of on we additional a the will meet sites, that end in in Mounjaro's additional at an add provide in rapidly the demand to site XX, our actions is strong Availability To seen positive with plans as Mounjaro's operational also manufacturing diabetes other capital allocation. U.S., to launch substantial by of factor we incretin and coupled business, for across doubling manufacturing capacity, become Carolina On update the XXXX, XXXX. fully have

R&D drive X capital invested billion combination of and For year, $X.X we the development future of expenditures, through the a investments. months growth our first business to outlays

returned billion in addition, billion we stock. and in dividend shareholders repurchased In approximately $X.X $X.X to

and return augment capacity, for external excess Our shareholders. in guidance. expected capital allocation launches, priorities bolster marketed and pursue manufacturing prospects are our new key to capital growth pipeline, fund products future opportunities is Slide invest to to our our our financial innovation XX updated XXXX

million exchange to for year full an guidance revenue our of additional a our since $X foreign Our $XXX headwinds year for guidance. exchange roughly from compared of impact the of of foreign billion rates outlook headwinds revenue total now previous includes original update full

research and unchanged. for outlook Our margin, gross and development SG&A remains

months reflecting includes now charges of X in milestone acquired approximately total $XXX and the guidance Our first the IPR&D development million, of year. charges

this business any of pending impact in in guidance [indiscernible]. acquisition the -- acquisition charges And QX. for potential We not development IPR&D not remainder of material the or date including from does or have the milestone year, development recognized acquired acquisition to include

is reported operating launch Our approximately intangible unchanged non-GAAP to impairment by change remain Therapy approximately to expected asset operating XX%. margins a now at for XX%, estimated basis, in our On due Gene driven GBAX timing. be the margin

and basis, XXXX. expected $XXX during for expense the of be reflecting range $XXX other non-GAAP on in in to On to the expensed range income losses net is investments net securities unchanged. income a remains impact reported and million, other expense equity QX of Our now million

provision amortization includes research the of Our year requires favorable first in for months and expenses in Act of of XXXX purposes. tax and that and the tax X capitalization Tax development rate the EPS a impact the

be continues effective financial the Congress, Our to full year for assume repealed this year the provision for guidance full will or deferred by XXXX.

rates research of before is XX%. then the Assuming year, to these the to $X.XX $X.XX we acquired approximately of XX% the our this now in expect EPS reduction full and QX. per in tax or impact $X.XX range range which by QX to non-GAAP in guidance this for reported as to lowered provision $X.XX of deferred tax cumulative includes on rate repeal XXXX our lowered by to EPS well year non-GAAP our EPS approximately by immediately Based we to of occurs foreign non-GAAP impact and range negative exchange rate $X.XX. from expect milestone If guidance the expensing $X.XX tax repeal $X.XX effective we the deferral have development reported costs be our not in the end the impact changes, to driven incremental non-GAAP this be year, be IPR&D XXXX. and as the is share $X.XX be The development the XX%, of charges and our would

over turn call the to Now year. begin of P&L provide a confident Dan, with thoughts think in to our pushes the few before and revenue, next the outlook core I'd I like to across the we're on Starting about growth as you business. pulls

positive expect and on launch products, the of new launches of We build to including strong across continued the our products. Mounjaro momentum pre-growth

While of generics headwind we have partial and our from starting we do the we modest XXXX, expect where initial for rates. will eroded Alimta's single-digit will In serve lebrikizumab anticipate the revenue, will be see that exchange revenue U.S., growth. foreign full continued XXXX of in a mid-QX sales wave donanemab, the Alimta the patent launches anticipate impact as year expiry catalysts low new in additional with we potential and mirikizumab pitubrutinib, only year next from

COVID-XX from to As for for available we make purchase. revenue bebtelovimab continue will antibodies,

but counts also the on these not and depend therapies. evolving for available demand on case However, therapies variants only COVID-XX will

driver Lilly. believe We be long-term for not antibodies growth that will COVID-XX for continue a major to

manufacturing the multiple opportunities, support advance and will as in launch R&D our promising We potential expand we capacity new products. future invest our of

Assuming one important significant persist, our have impact our due well. promise increases in growth. expect but most as the we capabilities future the inflation workforce, that a of Also, we also through we of will in to assets, that partially inflation making on XXXX pressures, are to our see to ensure compensation in investment to be talented right deliver

XXXX, to margin new critical We revenue slow pipeline long XXXX operating to to XX. expansion on operating mid- opportunities on launch our sustain top-tier help term. investments they in and the growth will look margin call these details guidance forward December maximizing and expansion While to our over sharing more are

over highlight turn over R&D. I'll to Now call the in Dan to progress

Thanks, for year Anat. another XXXX has outstanding been at R&D Lilly.

In we addition launch approval, for completed portibrutinib, by X mirikizumab, the have now to submissions medicines XXXX: regulatory end that could Mounjaro denetimab. of lebrikizumab, and new all

we addition, projects in with In our capabilities areas. promising improve early-stage acid all key advanced in our advance our and continued assets pipeline our we've of our medicine growing to next-generation portfolio. nucleic Plus

me let an for share I on to Anat's business, our Before R&D add update briefly update COVID-XX core antibodies.

mutated do bebtelovimab the also we've watching will believe on commercially bebtelovimab neutralize that not BQ we're available, new pseudovirus Based While of emergence data, closely the against variants. made strains. we new highly

labs broadly authorities. our do forward antibodies we can is potentially we have forward a an that path neutralizing health aligned However, there in consider if and need bringing with

Slide and key therapeutic portfolio. area. for call by diabetes obesity. XX, as important I'll shows Moving Slide last earnings core events of to potential select Starting pipeline with cover and developments our opportunities year. R&D XX the XX our since shows October

tirzepatide. updates several have for We

in we're For approvals announce Japan. to QX, in addition U.S. of pleased type X in diabetes, recent EU approval and Mounjaro the the to

submission based is expected the April year unmet to rolling is this SURMOUNT-X be need. to by to review the of the is an For primarily Fast facilitate granted serious we're from SURMOUNT-X, for be designation results that plan conditions have Track initiate fill a new has pleased therapies and chronic on Fast and that the the tirzepatide. treat trial, which complete; the development designed of We complete will expedite Track potential medical to the that weight designation end to XXXX. management, FDA which

these living working as SURMOUNT-X next as tirzepatide with positive submission with mid-XXXX we as Assuming we in bring data the We're hard results, soon action regulatory to potential obesity year. complete to late rolling for as adults to expect early can.

the tirzepatide of presented without design a beyond also adults and with events. morbidity to evaluates our the diabetes placebo obesity cardiovascular SURMOUNT-MMO, We of trial study. in traditional Phase and treatment SURMOUNT-MMO tirzepatide on in III effects outcomes of compared measures mortality with broad tirzepatide obesity set living

secondary We're including the measuring addition adverse our demonstrate a X tirzepatide's management CV weight to in and multiple to goal traditional development started population a our the of diabetes, patients study X-point look risk are of expect in the has at-risk metabolic events, X the is primary and In outcomes. our from tirzepatide's and type cardiovascular SURMOUNT-MMO, the start also of X practice. X prevention seen results for is other and to of Transitioning in type The SURMOUNT-MMO developing in clinical diabetes not plan. representative to but impact as we the We've basal endpoint, key we outcomes are loss. renal fifth where the both registration future. a outcomes. III primary to rest to we just more coming weight incorporated of study chronic studies occurrence initiated, Phase and confident diabetes FC all-cause demonstrate sharing months. composite obesity we outcomes improvement events also insulin final potential with program SURMOUNT-MMO endpoints, of studying living mortality. of and health now event a only that to As that reducing more Quint the includes broader latest weekly result extremely our in MACE secondary across the in portfolio, obesity-related forward

the medical device platform this management to key personalized to begin excited to this of and forthcoming FDA We're the Smart received and platform. marketplace year. for diabetes also Lilly's Tempo We Tempo approval component Button introduce

month. for high patients this cancer positive study of for of results risk adult with in HR-positive/HERX-negative line with node we've recurrence. performed breast another interim In previously therapy by what incurable be life-threatening MONARCH-E, are treatment we seen presented analysis of early developing San only of about metastatic look communicated, The with the expectations CDKX/X enthusiastic disease. analysis and of our Cancer approved next will excited at publicly. endocrine substantially to we've the sharing at Verzenio early risk adjuvant data ability inhibitor oncology. Verzenio the forward adjuvant Breast reduce breast to to Verzenio's Symposium the we Antonio combination in the We're the Moving is setting, cancer now high-risk and

or locally also the accelerated tumors solid approval announced for lung Retevmo. cell deliver with as to advanced fusion with that We the or gene to adults with patients adult We're to locally pretreated Retevmo cancer with RET granted non-small patients test. metastatic Retevmo advanced an FDA for of to have traditional benefits more regardless tumor opportunity meaningful by grateful across metastatic also types approval with FDA-approved granted more a tumor a RET detected gene clinical And in type. fusion

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is As a regulatory action mantle review in reminder, cell under priority pirtobrutinib for early with lymphoma inhibitor FDA treated a previously XXXX. expected and currently BTK with at the

and and who over monotherapy upon life continue patients to studies the need of dermatitis collected III across improvements to the durable results for frequent we've every accelerating become improvements X-week about skin moderate can CLL provide Switching inhibitor. XX-week could lebrikizumab treated trials similar clearance severe population. data We our with Notably, BTK a patient X,XXX results the amongst induction conferences. in recent patients provided period. from large lebrikizumab first-line response achieved atopic pathway presented patients spare a dosing in disease options also Phase a of robust clinical a for dermatitis, previously believe that quality treatment dermatology lebrikizumab of once new in approval with a less data itch, showed significant discussions in to XX Based at where patients, and provide dosing. sleep lebrikizumab We the diverse X moderate there's with the we atopic The week biologic in immunology. detailed to to FDA to the for with potentially also that maintenance have suggested

we've disproportionately severe As part an evaluate who to trial diverse of people dermatitis and population, color higher a forms struggle with for of our patient efforts initiated lebrikizumab recently of often prevalence with a the skin more reach of innovative atopic have to disease. clinical

a to in to the BLA holds Europe, now for submitted have indications FDA. the for Almirall, who and authorization. dermatologic And develop rights lebrikizumab commercialize submitted has to We EMA

We year. expect who we the potentially to of EU in and next Almirall, genetic end to from chronic important decisions medicine the this U.S. look bringing both suffer with efforts regulatory this Together forward medicines. our disease. patients to in by the Shifting

our ripe ANGPTLX we improving talented at from gene of our approach thrilled defined this diseases, portfolio forward an a an sharing that alongside results proof-of-concept we're to area the the who our neurodegenerative pharmacologic loss. patients. need to technologic look Prevail, And Hearing upcoming team last that for severe through believe Within temporal disease. data advance we're with we therapy atherosclerotic Phase ear hearing siRNA development not treatment focus program their biomarker development. is meeting the fatal our a We Lp(a) neuronal on year, our bring excited with shared scientific advancing we and about hearing about Akouos where of to opportunity been experience for outcomes historically see siRNA, II programs. medicines. our cardiovascular unmet has particularly will an patients optimistic You'll molecule, have now of to of in our help loss with Prevail advances Therapeutics loss This therapy gene advanced cardiovascular using genetically And for to transformational inner therapy, benefit where is is first genetic the gene welcome of of sensory siRNA area therapy II. to prospect asset to delivered dementia. progranulin therapy treating to gene gene frontal Building we're Phase we're

last our Alzheimer's have me disease, there Finally, of since number a developments call. let to been turn where important

see lecanemab. a against we company for Phase positive As top were to to III dedicated pleased results line Alzheimer's, fight the the

the this approval. certainly Following III dunetimab's study, our Alzheimer's which, by of application support if These and on to loved working early Americans study is living X.X and and benefit may which with we to middle expected positive, data estimated the the based in to traditional study, million XX our from and safe reinforce important plaques effective FDA people access our Phase the amyloid lecanumab approval TRAILBLAZER-ALZ the accelerated TRAILBLAZER-ALZ devastating for our the worldwide confidence In and readout disease. regulatory will the with this further and meantime, slow early removing million TRAILBLAZER-ALZ XXXX, availability with 'XX X forthcoming on disease is impact form people and of the The of donanemab continue for symptomatic of ones. their seek in basis therapies data.

ahead the on we our bring Accordingly, Alzheimer's in work can therapies patients. to confident excited patients drugs the opportunity in and next-generation plaque the TRAILRUNNER-ALZ, impact dosing patients. are acknowledge has are potential provides Phase we our have anti-amyloid hard the need, Remternetug antibody. these explore and regimens we to we for While portfolio for our and our rapid in to amyloid III first program initiated trial Remternetug, clearance flexible demonstrated and deep disease

trial in with a results as the lowering head-to-head lowering X, we endpoints Alzheimer's studies. in now to donanemab have aducanumab co-primary with plaque of on TRAILBLAZER-ALZ safety our disease, on consistent Finally, achieved expected profile to positive donanemab comparing amyloid previous early amyloid patients

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productive pipeline, we the developments While also our portfolio as of shown a most today at have we was Lilly. Across on number you notice focus slides. QX across the late-stage early-stage on another markets quarter our assets, of

I call back the for remarks. to Dave closing Now turn

Dan. Thanks,

quarter. briefly Q&A, let go to sum we've the we third the made Before progress me in up

U.S. early-stage end strong launched also towards and our we medicines same potential launch. investing launches At continue next to the in We the new continue recently progressing Mounjaro's externally for while our discovery advance to pipeline, our by and X pipeline year, of including internally grow time, capabilities. medicines,

in prospects. long-term remain progress our the we've made, we With growth confident

over I'll Q&A session. to to moderate the turn the call Now Joe

Dave. caller. first like we Lois, questions take We'd as Q&A to X for we're you session, ready the callers to as ask please per many from Thanks, please limit possible, questions for the caller. the your instructions and so provide

[Operator Instructions].

Schott The from first JPMorgan. question from is Chris

gross on guess two here trends had to we here. just is just should Mounjaro. thinking I from first net on be I about the

like do sounds XXXX any capacity all about when launch I to exceptional as you between issues early I is, now when an XX% talking as Trulicity capacity so and second then access. comes you a maybe we And you're a Can trending in access Mounjaro my question currently? facility out look the asking kind at do manufacturing could bigger what the we 'XX. just where think point think double you're picture point at really be that and this been that end uptake limit see have It to will we was additional online? that talk into where drug by what's at look see on be Mounjaro of guess of will far. I'm you'll question of about given capacity you position with similar in

Chris. Thanks,

for capacity. maybe and some net commentary the I think Mike? go first on on gross trends I'll question both Mike access manufacturing to to for and

Okay. I that. Thanks, questions. Chris, appreciate for the

at that performance before were looking really that of at focused than As Mounjaro. guided decisions net value revenue. took more recommended for we long-term better a generating We indicator revenue. look you on It our was launch, X we

disciplined long But term. bridging Mounjaro. to make we bridging We in allowed we are for wanted access. we achieved short to as have $XX for look to that who we build, sure we that that in X access program broad we wanted would place formulary We First, a term, confident that gained until that decided on to of us they the put their the confident program sure were diabetes and not a had good build to still be make patient going then bridge people going with a access cost that we're out-of-pocket low were we to and insurance. type

right and too be you're going decisions. term-focused, not to the short If gain pricing access make then you're driven to quickly

thought the negotiation we program approach. with we've the that's to tied taken that's So And and the approach best disciplined during held true the one bridging the was X we've launch. our

insurance of So had In with we as the third what had formerly access D people payer we'll Mounjaro. access. see Part will is increase quarter, commercial and net price XX% gain we

take grow X, of achieve upcoming And make we'll we is in very will moderated we anticipate access to XX%. get sure that we And broad access point. for the right future. we're we'll approach and As October what confident a best price disciplined still to the the still that jumped

We new adjusting should X utilized that net our start bridging to people are volume revenue. for but with diabetes, will impact program it's impact further also type ensure which

quarters over expect will we So Mounjaro. that grow net price upcoming the for

assumptions. titration situation, GLP spark community, many a uncertainty important competitor the performed taking our in long-term which facilities current yet is abandonment people well As visible have But are given interest patient satisfaction supply then type referenced. really just and supply manufacturing has them, Mounjaro is nature new the U.S. our brings prescription patient it you steady-state, and conversations viral for to dose of diabetes with tremendous The and launch diabetes all X that while with committee, rates adherence our which the Mounjaro greater our results it we comes X forecasting really supply, maximize that for exceptionally experience given that actions the to We're facilities that dynamic it chain a since Mounjaro. supply ramp production unprecedented community with launch. up type

nature that perfectly it's aligned given won't the production So dynamic to forecast this, weekly demand reasonable assume of week. each weekly with

interest produce type our Mounjaro's minimize work wholesale people going meeting orders they look dosing the at for product profile. well we position. short-term X strengths a have because been any diabetes. we're experiences to launch in or But high So in stepping this back up that great will avoid some is impact our If this as a supply extremely tremendous, picture, for and delays will the patient a teams longer-term have and hard some happens, ramp taking intermittent chain. in with

more market Mounjaro We gives had us expect growth expansion I because future. manufacturing we in And Mounjaro's which launch the increment confidence think has fueled foresight launch potential significant saw before product. just the the the of to we initiate significant capacity

a long-term with we're So position very good Mounjaro. in

Stanley. from question Morgan Flynn next is The Terence from

for Maybe me. follow-ups two

supply North is the way that you're on half I'm first think can but any anything you you of run to on just there's can bring year? Carolina bridging I it to kind Mike, know just I us side. you expected got into mentioned mean, about then challenges maybe sooner. changes that the sooner. manufacturing program, wondering kind of some online bring going of board just So year-end, to through the you've kind of help any the you do if there. made And

how represents tell of So we change what to that may type us different forward? diabetes the on should the that patients and percentage on X you volume currently the about be will think not Can forward. with

Mike? Thanks, Terence.

they They available, supply. to maximize all every soon and that teammates supply. Research results, of supply, reinforce that supply have facility exceptional get Triangle production continue on use And main way Yes, for the manufacturing look as soon we'll as manufacturing online delivered have facility to Park possible. good and as all is deck make that our to I'll hands our as

leadership So our manufacturing confident we're potential we're I And in our as long-term personnel and for said in confident of before, our the very tirzepatide. there. ability

your of of how With program, and question much was. I around Mounjaro kind it bridging think use was off-label the more

just to As with all in excellent our diabetes, The has that the we activities line and that and promotional place are execution. with Mounjaro in X with We're with type promotional line on-label you label. know, ensure wanted. for our in of processes approved been was disciplined in approved pleased everything patients U.S. launch Mounjaro we disciplined have very

physicians this in has driven both So we've a very prescribing high and Mounjaro. by been interest and encouraged patients experiences,

has. those medication starting or they who individuals don't is We a that to perfect we haven't at what data been to are best -- a diagnosis have data Mounjaro, not. The look previously patient whether whether suggest -- have the have we diabetes on

Given expect for focused that of our that's see seen. diabetes, people majority type X solely we've on diabetes, use and promotion we what the to is X would Mounjaro type

of we Mounjaro third diabetes patients X medications. we fluctuation the about X/X type from saw While week see of to quarter, new history in week a starting with

been diabetes who treatments, to diabetes of X type diabetes. X/X patients -- yet remaining treatment as individuals naive newly are the diagnosed could diagnosed X these who type be individuals or either with For patients haven't classified

The Evercore. from next Raffat question is from Umer

if you type early think how stands support. Trulicity. could a sales. And quick Mounjaro. per extent on inventory and for contribution speak Mounjaro higher revenues out Perhaps TRULICITY several and Maybe launch quarter compared questions couple to -- were you the the launch. gross differences of A, one compare to the if a was I B, speak the quick early per versus the what did in patient any into the net to Rx Rx into is to could I just dollars specific U.S. and And to of trying third the

what what surpass volumes in majorly You the early have Trulicity doing on. you're Mounjaro.Clearly, Trulicity early did launch majorly, versus did

Thanks, Umer.

Mike, on to go both you questions. back So

First to sales, Trulicity. one to gross then the that contribution and on with would net versus QX saw what inventory how second and compare on the we

for also or Okay. supply soon QX to was accrue Inventory as product, that's But to XX%. and patient whether inventory. for used Good contributions discounts product question. the the pharmacy shifts product demand as that a sales that whether our in I in rebates used channel we is note

big look we of do like at gross to the to is Mounjaro change did versus comes launch the have bridging you is, we Trulicity at net, the it Mounjaro. not program the launch Trulicity if As for a launch

from Steve from next question Scala Cowen. is The

select be question. on for So SURMOUNT-X? perhaps And tenuous think obesity not diabetics than the it request is at when filing and relaxed to relevant Why not SURMOUNT-X? first that's the tirzepatide the given of given seems FDA submit SURMOUNT-X could an requiring that does in look interim for is smaller obesity it value, study it that seem is FDA that would particularly Lilly does from results

Granted Lilly's in Second, at that and Lilly has China, driver a large so in why did steep is, critical Cialis believe, in a largest to but such rights to future? was when do -- for only as at $XX is was footprint Lilly there, Mounjaro rights Lilly Lilly is sell Mounjaro a your million. Japan point has long-term it to when one this second done presumably Cialis before, Mounjaro co-promotion whereas market. decline, selling I

Thanks, Steve.

FDA and your Ilya. for second then the first So the go to for go agreement submission we'll tirzepatide collaboration Japan, around to question in question the about And for obesity, we'll Dan.

Dan? So

off there's don't the question Maybe Yes. the driving FDA data any start any just that as for in FDA on SURMOUNT-X requirements. here specific anything see concerns. worries safety that. like We such by anything Thanks, relieving I'll with Steve, concerns that or or

X with have thresholds obesity the weight of on held as is with defined that around X that's with primary studies discussion per chronic is FDA having And being be in FDA in management guidance of multiple a having requirement for the indication, to studies think guidance well-controlled to consistent and I just for that studies. population endpoints the the trials requirement. weight adequate loss

Thanks, take Dan. the the Japan Ilya, tirzepatide? around want do question to you

Yes, you thank the for Steve, question.

right, critical is You're a market. japan

an tirzepatide preserve believe maximize will sales will significant of upfront of to in for for And we've Like will Just economics of ongoing collaborate. just a partnerships to Japanese and for is clarify, we payment successfully the scale Tanabe our local launch was and have and in the experience partnership We to which growth Emgality, value [indiscernible]. allow this Trulicity, we on our the in diabetes. brands. with partnerships treatments. million we've we us consistent had for in payment from the that Japan having clarify, $XX in together, with Japan like innovative for number And does had recognized Tanabe and that economics commercialize revenue collaboration for Mitsubishi success companies Mitsubishi Japan Mounjaro strategic to

The from next Geoff Meacham Bank of question America. is from

for you you for from cannibalization the Mounjaro driver next how role other maybe tirzepatide years? few switch beyond the there you do Mike, low on syndromes other mentioned guys a the mind. in of playing question was you or talked a about sequential Trulicity, added what indications like second few question. to then the trends but additional guys a have plays a broad for coronary MMO indications to obesity, Trulicity? where see what and of And study, Dan, cardio rate but lot Thanks And the out obesity are come

into you that? do like how So goes the what's the prioritizing guys plan here investments tirzepatide, from for on math clinical that

Geoff. Thanks,

of Mike, expect we'll trends of So go question you to you and expect in -- switch ongoing for go might we'll for terms to we rates, development prioritization sequential the around plans. and what Mike? tirzepatide then Dan,

typically Yes. launch What a the go new time. to will product rates from those over another see switch for you is people switching down actually our actually the incretin rates into class switching incretin incretin, the typically is

that The to would real diabetes. grow here what that's so anticipate. I market opportunity is proactive X treat type before And sure make and being the to

Mike. Thanks,

Okay, Dan?

Geoff, can thanks future are many we on tirzepatide. the indications consider. for There for question that

in normal lot sort As you tirzepatide obesity-related possible metabolic- point benefits restoration metabolism, we which diseases. think a of with is out, have and to going and be of may of loss weight

to we when. ones which pursue do how So pick and

as health think to data such around downstream a generating that tirzepatide I initially, of lead been our thinking when a drug driving has that body shows weight loss benefits.

study. MMO the drives that's what So

it big expect disease, is segment, patient about how patient we a think improvements segment obesity earlier. year, restoration benefits and where normal metabolism. sleep rather understanding next that have that We see this indicated the and dangers sort of of than or we to noting we of already apnea study can medical patient underlying of how a think as about weight those almost study, I in that loss will all next big of we as more, segments heart all an the adding is have of That's ongoing. have the are how commented which obesity When failure

we obesity more consideration us company. for loan one goal long-term Geoff, for Finally, here, as fighting I a think see is

understanding And lots of we'll have to hope. so contribute there'll medical weight our be multiple generations of opportunities And of drugs loss. to here, we

from from The question Mohit Fargo. Wells is next Bansal

on one maybe obesity. growth in Mounjaro So question

when are about more obese, type prevention. patient current million trials, see I not of primary secondary which you the XXX setting. are you So talking you're talk diabetic. population, prevention at of they if about look But

important prevention So to the market this is get possible is -- how in obesity getting a at question done trial patient point? broadest population primary how the to are

the Mohit, question. Thanks, for

little echoey a bit were You there.

the obesity opportunity. that? Mike, the you take got population how to that I patient gist to around think do and we want for maximize

who actually to you question. to typically happy happens patient has it the product. I'm kind additional answer that a get you Actually, with it with to to counter segmentation, out, Yes, either a indications. with and a obesity, what try explain BMI globally. have factor a have it's which of is going XX or Actually, U.S. indication the a obesity, with finite massive of Typically, that over BMI you're to people population in for risk XX, broadest the

and our of will order necessarily improve treating in health to is access the trials outcomes population, expand aren't obesity proactively patient additions demonstrate payers give the to but for to product. physicians to write the so And to that drive

Seamus Fernandez is question from Next from Guggenheim.

of couple ones. quick a So

Trulicity it's related is the going as of to Carolina what capacity, capacity is It's for North potential going also versus that potential as So well API much manufacturing be manufacturing, Trulicity to manufacturing more of expanding actual really the biologic with point bottleneck your is that pen of expansion pens And to there? regard main my understanding largely pretty manufacturing. is understanding be to manufacturing on update Trulicity. the the terms pen all in just and the can fill-finish and facility, my pen the you the the this us for

get So the on of and of the rule to that actually benefit for manage could insulins. fees Lilly the of that. understanding a actually just and going insulins paying are providing are through of many the trying the to just There competitor, then to as change a questions number around insulin. penny be better Novo, second, And Medicaid of the how sort

that manage wildly seems it particular, Lilly unfair to outcome, a how trying in to just of industry. understanding the to better hopes So get

Thanks, Seamus.

facility the also question for Carolina I over on kind So of to dynamics, I'll think he's if first the North on manufacture Dave. I comment I dynamics. MCAP to to the mean, hand insulin, want think referring the David, you

I if in jump Mike, wrong. that get And can. I

we to the that actions to to Trulicity, this. be we of fair to the step which Trulicity We would we next next Should make to by as demand have capacity we've will primarily the are back an well. plans constraints see in So which step-up, And happen related did now. I in the on to demand that because a to slow capacity, comments year. give that Carolina, that, that shifted expect happen But will above producing North too our balance end be a manage And in continuing. right demand we'd say increase Seamus, towards that we're internationally just on think just will competitor, taken trying internationally. of have some today domestically, -- of quarter course,

more sites That X in online Charlotte. we in will 'XX clarity, come in facility some One Just actually Concur really capacity Carolina. and North there's one more 'XX with fully. the near road for announced in second also recently XXXX and beginning down

for in some is a steps pretty the So finishing and we'll the company also Trulicity, and is process those take on parental what investment Carolina steps, used aggressive Mounjaro. the but drug We has focused approach. which taken that North platform device filling call the are

to So flexibility supply and more is used also device agilely. us match And gives demand that other Lilly biologics. for

perfect, it inside to agility. sites skew match I demand comments in X are give out, placed Mike's every a think that of like every does Anat Although XX I'll days, said, earlier North point perfectly of well not huge. as Those But lot Carolina, produced. were it's of SKU we us can't

global first the our is a when it's similar the literally side one second So will double capacity online, and size.

well it the big So not the supply bottleneck the looks API in uptick and the a taken is which synthesis is which given some use. to the We've we've peptide looks API early It's to Those not bottleneck, process be Mounjaro, is substantial. taken and expected we actions currently placed not do speak capacity. expand chain. also different side. CapEx quite decisions, to that

term, approvals lapse these supply, a And this extremely said, sites little caveat Of fashion, Regulatory around current that ability massive course, online of can to the challenge can long in an to bring big have step-ups Mounjaro. But but demand. a course, competitor of Mike supply new volume things confident required are we that's outlook. And all a go meet is, wrong. our we're on-time do and of bit take time. our we Trulicity will in should as

main from message the I that's today. think

As to January 'XX, or beginning you're to for use to will XXX% for payments in states that above that in be MCAP, CPI a that on have of it Medicaid relates rebate will pushes that programs the required medications be product them rebates lifted, we our right, cap and to pay situation. penalty

glucose-sensing Connected and approval III announced on not the of a you as got progressing for program know, which And our formulating course, got, new things, think, well. thing We Phase exciting new weekly as inventing I to with we've reset insulin do we're Care efforts plans that, And deal an although deal that to to best have insulin. with is that. keep on plans calculation. we're We've

we'll efforts, that So are 'XX, long-term manage I of think, all approach 'XX. early tactically the those end event the at through

from is Shibutani Chris Goldman Next question Sachs. from

data going there. terms potential that studies were terms next the impact see time Should potential submit revenue in And from highlighted data? those of terms FDA? or also I that anything and a what maybe any data expected adjuvant regulatory influence to see we metastatic you'll we the might SURMOUNT-X Verzenio Can we're not in at for Two on for the on trajectory questions. you planning if And approval anticipating of standpoint opportunity clear that would requirements implications to have X, believe that you processing? obesity to required contextualize half of to, those One to tirzepatide line the the Second, you how are that and the be Verzenio in complete that year. on of believe, us SABCS. be you be might in from of are some just the split? potential and the first once for

Chris. Thanks,

Okay.

X San Conference, preview. the Jake and maybe and requirements Dan, to go question obesity the go Antonio and X, regulatory around on then we'll Verzenio we'll tirzepatide For Breast first for the to

Thanks, submission. we'll understanding don't needing Chris, for that that our and anticipate and as is based submit SURMOUNT-X said, SURMOUNT-X, X SURMOUNT-X we on we and

those readouts. from implications time study line So to no

Verzenio? you on do to Jake, in want jump

Yes, sure.

in mentioned Dan interim we Monarch to were as conducted a talked the as prepared going we that. we So remarks, the of that had do preplanned earlier analysis about year in

of of course, cohort ITT be what well survival. Really at endpoints, both the as pleased So we've as overall those with We'll indication. all population at X presenting Antonio. the the DRFS we and study IDFS, the looked in seen across currently San labeled

I to ought our the two expanding want to be in data new think careful the there's it that X One continue how time. components about increased see here. follow-up? analysis as And you over themselves, do indication to think look think questions to does but think relates are about with the obviously, is, reviewing how I data December. I as labeled the the evolve And potentially you to second data about the those is,

question Next Bristow from is from Colin UBS.

on the obesity. discussion my upcoming bit of Amgen's on There's quite Congrats side, III quarter. around from Two first been Phase a data.

just you any on was us you on I'm could mascutide? remind get Alzheimer's your antagonism? on we And part And side, dosing agonism and beneficial. there's suggesting antibodies? donanemab, then actually on of GIP redosing you just any data achieve related antidrug when just Was of negativity? your thinking the this, And or given on side, with be I'm may part to when your to that GGG some decision development so about updates regards stopping give versus us amyloid dosing maintenance could to a thoughts strategy wondering discrete pursue just

We'll both Dan on questions. go to

obesity, Amgen's antidrug and data one and First Alzheimer's to around one second around then dosing discrete related the antibodies.

mimic response strategy as much Starting how general in been obesity here, body's to our with food. the think as about has and own to we possible Yes.

incretins. hormone to by gastrointestinal your -- rather is decreased lead satiety tract GID in and response are the eating work calorie by That's major then one of they and secreted food to submitted incretins how increased So expenditure and intake.

case, surprising strategy I if also and of Amgen's have acreages normally previously a we made might wait expect track could internal think decision or not. consistent to different We've That and With development. communicated sense yet to this use our Phase which pursue of to III for further GGG still we'll data we in agonism thinking it make year. So antagonism that mastatide biological this understand for respect a that data wait next-generation is a of probably II year BCG and data yet the that that's incretin hormone In whether than to see and effect have data. effect on proceeds this ahead humans. to is in to and, Phase

that with to line absence of do. notion It's taking can biology, are we donanemab based to take was plaque-clearing to plaques and to dosing the for around to the are we here something gone, was stop understanding the that certainly, referring a to it second Remternetug see antibodies. That on in But once our because as of idea antibodies ongoing. a pretty do question specific here you that's The antibody. discrete antidrug a in strategy, to clear, that are and nothing the plaques the pioneered or brain to benefit they're for having specific the still disease not once their plaques drug patients donanemab, target the of continue have antibodies you're

own we've data reversion in there patients show therapy. biomarkers that really come shared no Our off is that who've of adverse

to supports that So we of hypothesis. confirm so that still We'll TRAILBLAZER-X have in as though hand, early, to appropriate. far, data look dosing cessation the it's

from Risinger David from Securities. is question SVB next The

guess revenue. there translate the although fully was first, I third in didn't coverage quarter, XX% in U.S. the that into net

customers clear was to So for at access And that translate respect U.S. I not second, the negotiations Rx understand this national will XX% provide could may about may October other, should demand thought why could the stocking, with first sales rollout quarter about just on XX% but we ex to have There of prospects, paid just formulary the as to it the certain question I'm sales downstream required, one, of you the immediately to that but might the And a because comment better from about comment. was not think in quick more outstripping was you sure Mitsubishi sales of manufacturing if payers a risk in think that level a case? Was plans the it wasn't the be sales. color sequentially? to and capacity. some being help if U.S. you then additional one this U.S. tie how provided because ex yet, factor U.S. we of us about think coverage that of And about context a X. should the about you how be talk to fourth how

So when if question. you clarify the address could first you just that

Thanks, Dave, for question. the

Mike maybe and the second we'll and a coverage. to think to what one, the bit about is I first And around the So we'll at one, co-pay timing. OUS dynamics to for card. sales discuss then about go for And go to you're prospects talk getting Ilya

Mike? So

channel from figure. David, question. that Yes, percent the was for was in comp the a Thanks, U.S. Okay.

-- our look -- matched paid that scripts rate savings when were card, paid versus you since rates. closely and access look percent the at launch you our that data has through covered the On in at

kind the would the best bridging going I paid indicator percent for the So of are say that's that versus program. through

Thanks, on Mike. Ilya, OUS?

Yes. Tanabe market. upfront actually in the future when payment. Japan Mitsubishi commercializing payment are we and on start the and Basically, of Mounjaro the Maybe economics be would the the selling first economics and dynamics upfront

payment. So that a onetime is upfront

that's so at for economics look would the And future. the how I

in of any X I is to ensuring the Mounjaro can we market. can for important U.S., that that to Mounjaro as we think given whenever overall terms we of one evaluate of access. type well outside will ensure supply build our patients market that determine a In enter as up appropriately commercialization of And that aspects the we that's us

a reimbursement. As gaining most between you lag and patients may markets also access for U.S., outside there's typically and to the know, approval for time takes it

that in a outside Mounjaro commercialization will U.S., have adequate a And delay so supply we enter the but and full and course, monitor when of being we don't the of that look we ensure significant we anticipate market.

Louise The next Chen from is question from Cantor.

but for you for to study they'll positive I playing question you or MMO? be broader SURMOUNT-MMO interim look in will to then will for had is, And you you time? think an have you of Novo convince outcome So know first enough this And opportunity question for had not, said second in the don't do a the payers I look before you Or study have out a GLP-Xs your and do SELECT here? is, your all over like data? see the you injectables market I how think if

Louise. kind both. Thanks, you Mike, let handle of

for First what one see for the positive we is prospects oral around market SELECT for study. then around glips and

Okay.

On mean, the our very oral oral X both products, in in diabetes interested obesity. GLP I type and market research, market, consumers in are

attractive. oral prospects the very product an is And of anti-obesity so

encouraged excited we're are that by NPA So program. very and by opportunity our

As to of get show study, it's if class. the it the products an the in of -- CV that it's benefits able comes positive the to with opportunity semaglutide, more Novo to is to me,

are Novo professionals and more on whether any going and represented are help more to additional trials think help product. our the be payers that or trials benefits I care it class by take action the health

think trial a will health we data good information I and so payers. in And think their and different, that will good it. is little broader little we a And and think provide our bit expand trial bit care is also for professionals while nature,

versus it's more I to class, a SELECT, a need treating good professionals. is show health new study comparing SURMOUNT-MMO think proactive be going good for really our to than be the for lot So the today. what the we care information We for study, should do that. obesity more those trials me, will it's not And

of to will on could to one not. the as already, that for. like we for that it's if I'm that, decade jump one medicines because will and event data paid be We just lot really speaking obesity going number. are reimburse hypertensive the obesity. access payers commercial for way don't think expect or who in think there's accumulates Maybe analysts, out a become on over we to desire norm of play I think small then weight of balance I that broad chronic that And commercial a management this anchor a It's there the trigger the course the to

will to the will coverage one course, the big for in binary. or benefits due efforts definitive data next action think encourage efforts investors slowly Troa But accumulating where health set, both government chronic relate effect Lilly's waiting prove similar access other's the and I over of a And to this more time up years commercial the U.S. efforts about management. sort but weight to Of over U.S. be rather and those of the might ex wouldn't to open many more

from is The from next Citi. Baum Andrew question

A questions, couple of please.

First, Could and drug the at result the of year on commercial talk about early be the trials, subcutaneous. question. top existing removing this billion, in Do allow $XX only to It on going X second obesity in and will And Remternetug, GLP-X That's so unblind Phase accelerated market? the oral to this the potentially as will Abeta-lowering data, data compete market of it you're first you NCD II on DPPX the that to under me to of expect about as just diabetes how you 'XX but trials. to [indiscernible] Obviously, that look you it you at Abeta worth approval could back potential the or Roche introduction is question, have doing. launched on be effectively? to your time for post lines potentially? the order evolving point, then strikes subcutaneous is that's agents, both whatever clinic

to Mounjaro be is drug you So independent managed going there revenue if a growth interaction, to once solve you could no contributor or major to the solve that your this forward? very possibility

question. the for Andrew, Thanks,

maybe hand on oral back one the Glips, for lines, second well for one on go as and Anne Remternetug NCD to chime the we'll So time the the then And potential dynamics. to the for commercial as in first Mike. to removal

Thanks Obviously, is we've so that excited as we're lowering. program. the question to started much we've Remternetug. And the III the noted, amyloid study, initiated for on Phase assess you first which

excited Remternetug, at program but III clinical was what initiating have far Phase we've well, we're so about with broader as we're which donanemab, we're done a the for looking the that next seeing endpoints generation. We as

clearly you're dosing compelling as see Remternetug. where we're the seeing invest based continue we donanemab's convenience said, patients. offer in it that on we of it platform a and clearance hope data which On we plaque. And have your to of will going the CMS, around us the form so additional as obviously, on showed And lot then think that question of NCD, benefit to convenience the now data now as II early, AD from an going donanemab, you Phase to forward offers clinical well was

data, CMS to position this Certainly, our have for is a we Now large that benefit. also decision. lucanumab time showing reconsider III the this study clinical it's Phase

before would Remternetug certainly, time Obviously, that is hope So is resolved not we the out. though, this clear. line reads

patients do, evidence to with cannot is And forward that requesting we is believe seen disparity continue from CMS care medicines. that really also have to this provide patients the who Alzheimer's in as method that's prevent we've restrictive have we've disease for Alzheimer's reconsideration getting and the to see today, disease. these Phase CD in past, see said So you'll very the I'm and demonstrated a leads will III doing what data the as to as reason and sure we moving same us we soon

have be resolved the I certainly, hope available So that by time patients. to this will Remternetug we

anything of opportunity? the Mike, oral in to Thanks. add GLP terms commercial

of additive the Andrew, think to was thinking X% Rybelsus class, we launched, impact exactly When it I demand happened. class. the injectable to Mounjaro what you're or about see the it and Mounjaro's market, Rybelsus not expected And that's from launched, coming correctly. GLP. It we oral grow more is then as only

So I think you're right.

I attractive, think opportunity. very the we're is and pleased with versus it additive

be of a I is water interactions oral oral followed food, which it's efficacy and to impact market, the there's which has as with between key product, what's injectables. well some think dosing Rybelsus not in the as limitations, some closely the can have of the and going efficacy if gap Rybelsus

alternatives exactly have higher, with get increase, what the So I in doesn't that and plan even as the that's of to orals potential place hopefully, efficacy that we NPA. food deliver, interaction market think see the being and you'll you as water

is question Capital BMO Evan from from Markets. next The Seigerman

Mounjaro like Manzaro, Mounjaro call. it's on it seems One

to you you'd on relative Clarity over And trial, on your why you the payer about the for appreciate CMS the comments coverage payers? bar of And efficacy I can't do time? more and by can the talk endpoint OUTCOME us your is question second at can for ID, for reduction gain sufficient Looking the of the you need approval comment kind potential that any trial. with access has positive If around outcomes in endpoint? been to primary my remind raised like the be any risk plan, on see other just and comment believe data? But FDA these and you you believe full will [indiscernible]

Thanks, Evan.

what Mike. hand we I'll on the to access, need the then the for question I'll AD, for for kind trial first hand of So Anne. payer And Mounjaro, and to over that over outcomes Clarity

take another how I'll shot time. Maybe at develop obesity it access see Okay. we and over

employer back about will over going time. every it's talked that independently Dave a steady of and decision think payer, to take I the drumbeat and if grow make every will evidence

live that commercial we're is tirzepatide D. approach already other for indications and other These The apnea. who for sleep that our by indications and heart supported with studying taking are people obesity we're Part failure are Medicare like

access unlock of and get indications for with heart the as and subsets or have access who as that of we MMO apnea And get build who people to that, efficacy sleep obesity there in will so we the we live toward believe payer failure demonstrate that our continue study. itself -- results

events the in life time, cycle will but grow tirzepatide. I think X are it So important of I those over think events

Thanks, Mike. Anne?

that on a we question, care data the to stabilities. thanks we patients, getting And Clarity saw in delay value is clearly, families, see question Well, maybe and of independent absolutely your highly loss partners the there meaningful. AD for clinically the

XX% disease should of the slowing stage of additional in to And the so impaired functional the a initiated disease more the in mean time stages. less earliest XX%

about and So results, they're space. in this think meaningful we're we those excited that do clinically

as we'll look reasons to And are that said, confident forward, those we're so see changed. and extremely what There we with we've many about donanemab. haven't donanemab

in So able obviously, depth Phase selection of it's clearance. the importantly, produce the plaque endpoint that we speed study, choice positive a as strategy of were we to commented, and patient you that II study then have the our and the

that for that space. out think So we truth. the then is closest a noisy a bit definitely And past, similarly. we be the clinically But the we it most in we endpoints your And will of the will showed the to enough indexing robust very readout question as We a perform we But always on this a And large not on study, believe is X. we've move on endpoint, best confident remain and TD that slowing, see in in our numbers I upcoming TRAILBLAZER-ALZ, as so just we'll always we've what move there. in believe on, expect believed powered meaningful. said we can of exact Idris probably XX% see endpoint all which that Idris.

the to Idris. we confident be of So continue about choice the

the continue TPX we'll in readout We to mid-XXXX. that be about see confident

The is from from Tim next Anderson question Wolfe Research.

a If I could just stand Alzheimer's minute. for

views question lot, ARIA-E so have that XXXX and question, KOLs that's donanemab is, And issue is me going to just the up, think you views be and does put because on mentioned like can the you data, here latest they still seem then coming on it readout lucanumab? next XXXX? far. guys about donanemab. data approval and even which differentiating Just the your pushes your of and not to something of To fail clinically the this third It you question, My seems latest expect whether in real that a what's thinking? readout data. you important cautious big bluntly, talk that Second in pulls downstream about expecting Roche your that to and data do are a best is are

pushes comment But finally, go give out on also there Thanks, donanemab differentiation. to And Anne Maybe an pulls expectations and we'll then the Roche, Roche X. to then in first. the maybe on maybe got of you level the and Dan thoughts Tim. high question extra lacanumab on your for timing for

ARIA -- I'll Okay. rates, last as Yes. which your Tim, think I'll And well. then on I question there, maybe take was

of But results with view of there's sometimes amyloid amyloid-lowering predicting increase risky X positive your of drug. of seen powerful predict. I lecanumab with are pretty got Certainly think we've that to important or a these lowering is of donanemab. number can a a is us from said I before, and drugs of III probably in sort again, I've here that readout remind of the what So amyloid a our a odds pleased But factors X also that help other of degree area has we're Phase us Probably lowering one in success drugs. of most -- both really there, all just X. Alzheimer's with hard been one to the of studies has the

some we take caution. So

love more we'd patients. good positive and news course, news to for -- Of for see studies more patients

over I sort I I it turn think of the question, take to other before Anne ARIA-E for and just data. lecanemab

I about that I are couple reasons to scientific presentation more we comparisons can cross-trial think think of important, bit CTAD. do our little at hard maybe it's at a of talk for rates a

time Just probably to important? have sort the TRAILBLAZER anyone's populations. Why trials, that be of all, different you're first you within at of looking trial noting X X is different to drugs comparison different able compare When of ARIA. is first ever patient done that

depend I the we'll disease with and on are probably ARIA time common rates more brain in learn patients think more severe stage pathology. over that of

I think likely be to that's true.

has of population, you can ARIA how even in in as for MRIs do, be different measure or Lecanemab has Second, have different more think. earlier same MRIs MRI if I donanemab the trials, you very used different example. than timings we

up ARIA. radiographic pick to more likely more You're

on So cross-trial that's another caution comparisons.

that to And what than in ARIA we serious rather results the radiographic consequences However, Anne? events the rates symptomatic focus see some need ARIA. I do as probably on serious that's particularly in patients. important, ARIA is

words that I the think in we mid-'XX. And mentioned TRAILBLAZER-ALZ then readout for expect his Dan during the X data timing, so as

a is from the submission. submit intention our and So the supplemental rapidly review FDA a timely data for we to expect

as assess lead use could the wait traditional in hope to that currently a XXXX. is drive We but expect data Phase would of that the take certainly, we approval we that III is certainly written. really additional approval, not So your of And that the and based reconsideration. to limited mentioned, an said, I the approval CMS uptake then first half we for how expect time situation. CED for comment, accelerated also in to early the we 'XX on would maybe

time that that's So we're on. the line

your Tim, question. Thanks, for

questions. I have think two more we

from Kerry Berenberg. is question next The from Holford

Two for me.

understand been What in in want evidence for away more Just X-point SURMOUNT-MMO, the adding base that you those up used study. are expedite X broader additional eligibility than And then just you and you a include on endpoints on criteria And firing question endpoints? secondly, has a mortality focus. rather have why events? following to drawing those I a do therapeutic diabetes SELECT your you're to debt. so traditional will Do why

the disease. to category to cardiovascular into taken II in. an your PTLX decision You've CME therapeutic be, guess, can move expensive I Phase risky participate

pipelines, consider is you event need positive, a around the through to taking decision would you do partnership market the these thought your might this So Or way assuming to be Phase interested? assets processes II alone? on just anticipate

Thanks, Kerry.

Okay.

So first MMO and general, Dan? in question design ASCVD maybe Surmount and one AngptlX on more second around

thoughtful two questions there, Thanks Yes. Kerry.

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of if class our forward. what With here. our positive that's a drugs as think II and to you we evolution So of it's And thinking I we this result. ANGPTLX, about respect ask a do get Phase natural do go we

reason for look patients. the promising course, for II do is we Phase Of drugs these to trials

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whether or alone about to terms premature In probably does that's partners, it's talk like thing of a anything that. Lilly

Lois, Kerry. take want you Thanks, to question? the last

Robyn from from that's Securities. And Karnauskas Truist

on first guess my is Mounjaro. question I

like about than if So supply we the about the demand, you think, you talked individual levels incur like dosing whole are and about -- greatest you can you what the predict might talked doses be And most? call, little dosage impacted. trends. But used higher do talk a what bit I what being

switching new. and think you XX% had I XX%

mid So is is drug's about class the for say hearing drugs. Alzheimer's, it have benefit And it's share dosing, talk frequent subcu? of the that it second, Is the think Abeta you bit what as the you Can of you lot of of the the mind doctors? that little speed resonates would think that a the we're Is doctors with doses important a on doses? first reimbursed? magnitude uptake most low go about thing it we once or full

Robyn. Thanks,

with dynamics? do to dosing on the share Mike, then that mind handle will question, the And Mike? Anne fill you that. regard So want AD and question to

answer question. to Yes, happy that I'm

world I to be real and going studies our think to titration the the XX was test, clinical different dosing needed we dose than in clinical XX. X, what and is the studies response

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or at got the of X plan it's us. dosing manufacturing levels You've your ahead when down to actually SKU month a for

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believe that And there out space on with to people I have starts the it how this really of think I successful so this showing confirm one do diagnosis. trials making commitment these our for the that have that sure therapies. that, was by pivot right in points patients ability to now we And the

disease. has All of that clearance some and but with that rapid first amyloid of learning over the happened setbacks the slows years, importantly, all positive most from in that, progression we've and of to that TRAILBLAZER-ALZ trials the this the the then showing had, of everyone experienced the that significant to of the showing space both insights trial led plaque, we truly the that

commitment to And some think, And so it's what had to sure of time donanemab to how we've on certainly truly perform. really, early we space, lot built patients so that continued we that months diagnosis. patients share get work next with commitment I in that. and the few accurate the diagnosed sure the is to a make of making we're shown has first is these that we've towards access in can that of year, pleased as mind for the spending that's drive We're

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then believe I what and in that will think we saw the design you'll TVX. TRAILBLAZER-ALZ see be how reinforces performance the what and in we

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see scientists this. of for to of think, I culmination rewarding, many it's the the here So

our forward of to with early movement next exciting next but for readout year disease. meaningful really and real So approval people again, well. cusp Alzheimer's look -- accelerated as And that year we times,

Robin, question. the for Thanks, Lois?

further queue. And there's no questions in

up Lilly team. Thanks, your follow today's and to Joe, with the us the hanging for IR I thanks Please team. everyone in company. appreciate and right. interest call All with of on the rest our

any you we have have address. day. a questions that not Thanks. Everyone, If great did

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