Eli Lilly and (LLY) 2 Nov 232023 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2023 Earnings Call. [Operator Instructions] I would now like to turn the conference over to your host, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

Good morning, and thank you, Paul, and thanks, everybody, for joining us for Eli Lilly and Company's Q3 2023 Earnings Call. I'm Joe Fletcher, Senior Vice President of Investor Relations. today's Ashkenazi, Dave Chief on and Lilly's me Anat CEO; Financial joining call Ricks, are Chair And Officer; Dr. Scientific Ilya of and Lilly Diabetes and Chief of Lilly Lilly; Mike President Immunology Skovronsky, and and of Anne at Officer; Dan Lilly President White, of Lilly Loxo Neuroscience; Jake Patrick Yuffa, Lilly International; of Obesity; USA. Mason, President Van Naarden, Medical President Johnson, President the Michaela by Mike and IR Irons, team. of We're also joined Lauren Springnether Zierki

anticipate we our call, on During projections results and differ on conference this to listed based statements making including current could forward-looking Slide X. those Actual expectations. several materially due factors,

X-K cause contained Exchange and with information factors Form the subsequent latest Commission. Additional to and differ and actual in that filed our materially is could Securities XX-K concerning XX-Q results forms

investment we is products decisions. provide of not sufficient our the for benefit promotional is community. about not information and and It's prescribing for The pipeline intended be to the

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

I'll to call over Dave. the Now turn

through In progress pipeline far delivered business we We year. continue made financial Joe. our QX, transactions. the results, this in future advance invested development strong our Lilly and to R&D so Thanks, several continued

progress Slide we on see can you As strategic continue against to deliverables X, make our quarter. this

from the antibodies, revenue grew and revenue olanzapine Excluding COVID-XX portfolio XX%.

with volume Our percentage new products and points growth growth approximately XX over XX growth, products. from products points toward combined percentage contributed coming our

important in bowel the colitis portfolio. for approved FDA U.S. first it's for in of in really's the treatment marks active type moderately This approval that announced a and Omvoh for we its week, inflammatory adults. to of growth Last severely immunology ulcerative Lilly's disease, the

our the updates for other important to several since had Omvoh, addition we earnings approval call. pipeline FDA last In

from for treatment kidney was approved disease. results with of at of of positive mirikizumab moderately risk to and evaluated disease And chronic of Crohn's for Jardiance with severely the Phase we treatment VIVID-X III the by safety the trial, efficacy active reported progression. Specifically, adults which the FDA the adults

complete In response third-party QX, we concerns a on based lebrikizumab or manufacturer. issued findings the with a stated the package, for inspection letter label. letter the no The announced that the clinical data safety FDA at

manufacturer to findings test to work to to with make available We FDA the quickly patients as third-party will and lebrikizumab the continue the possible. as

again transaction terms we the In the divestiture of new QX of financial completed further very on in quarter. results. and current portfolio, The will business focus we is which development, In reflected a once QX, product active had us launches. of this olanzapine to our impact enable the

the acquisition Bio, Additionally, portfolio, within Versanis Therapeutics our quarter, the acquisition the and as of Emergence Therapeutics II to as companies state and we clinical Therapeutics. Sigilon completed well DICE of X Phase adding

approved, Biopharma, if has announced acquire an potential that into oncology agreement expand therapies. to reached also POINT which our We the capabilities radioligand to next-generation we

And call, in Slide sharing quarter. clinical key important lastly, we we distributed are QX several events other dividends updates including and our today. On of regulatory, this a see X, since over list $X billion you'll

QX results. our turn over review to me Anat let Now call to the

representing XXXX. highlighted quarter, my X in by performance focus core non-GAAP financial Dave. of the business. revenue comments Slide robust growth Thanks, third performance continued summarizes pleased quarter We're of financial acceleration the this performance. our on momentum strong with in I'll

XXXX. QX increased versus XX% revenue QX

represents antibodies, COVID-XX strong from and performance acceleration and the QX. Excluding XX% quarter-over-quarter Mounjaro and the revenue growth revenue revenue portfolio of a Jardiance. driven This increased olanzapine in continued Verzenio by from the

high COVID-XX QX as with to margin new percent revenue well a increases realized olanzapine XXXX antibody expenses in as the of XX%, higher benefited additional portfolio, in indications, increased administrative the expenses. primarily benefit the expenses and increased as launches and partially Gross driven XX.X%. in the divestiture by and manufacturing margin prices, compensation of selling costs. from associated quarter by and offset Gross Marketing, product of absence sales

primarily driven expenses assets increased development expenses R&D research. by for investments higher XX%, late-stage in and early-stage additional

$X.XX charges totaled charges $XX $X.XX. acquired In impacted by which we negatively billion, $X.XX quarter, QX EPS. XXXX of acquired EPS This million recognized of IPR&D IPR&D or

Operating income approximately decreased negative attributable revenue percent charges. higher IPR&D impact with approximately XX% income for by reflected XX a by quarter olanzapine X% percentage to divestiture points revenue partially acquired charges, in offset IPR&D associated as QX, a driven the Operating the of and the of acquired of portfolio. was

tax QX of the by acquired in than increase was The approximately in effective incurred impact period underlying to the effective previously driven was this XX provided quarter. of same acquired points increase tax XX.X%. rate tax nondeductible IPR&D, with an rate charges represents guidance. consistent Our XXXX. primarily Other the the IPR&D This rate percentage was compared the

divestiture decrease impact of negative a bottom At we delivered from the the and of share $X.XX XX% portfolio QX acquired versus increase the the inclusive with of olanzapine of QX, associated IPR&D line, earnings XXXX, per $X.XX in of EPS an charges. $X.XX a of

Slide On we and effect growth. and rate revenue price, volume the quantify X, of

for revenue revenue U.S. Mounjaro driven XX%, U.S. in quarter from price olanzapine This and the increased cards the grew portfolio driven When and by growth robust by Jardiance. excluding revenue Net quarter, dynamics. antibodies, U.S. access increased savings of Mounjaro, the XX%. and COVID-XX XX% Verzenio

in U.S. price digits. single decreased high the net Mounjaro, by Excluding

prior impact expected second was the which dynamics earnings QX. Card Access of half Mounjaro U.S. calls, changes that reported Saving in on As in evident in and a XXXX, mentioned have price to we meaningful

continued this Europe post quarter. again growth to robust

the growth primarily from revenue Jardiance in Verzenio, was revenue Excluding Taltz. and by volume XX% up X% driven from divestiture, olanzapine constant of currency,

XX% QX currency. in decreased Japan, constant revenue For

with buying had onetime currency revenue period, constant the which Japan X% sales decreased customer associated Angeli. in related a collaboration base in the primarily upfront payment agreement driven by Mounjaro, to Excluding in patterns

constant declines. driven partially currency currency and of XX% in Mounjaro, price volume the Verzenio. year volume with by this revenue Moving by world and Encouraged by XX% driven to China, by growth of China, in in as QX increased the growth in revenue offset the growth seen of Verzenio and have XX% we volume rest was Jardiance. growth The constant XX% increased was Tyvyt

to worldwide X volume shows the Slide by product category. growth contribution

can categories you sales volume approximately X antibody compared revenue and new of abate third This the quarter. antibodies the quarter points QX. for growth as period of see, was minimal percentage absence As from XXXX. growth the combined COVID-XX base contributed XX headwind to nearly to of after percentage points The product headwind were will in the volume of COVID-XX a products

sales quarter. perspective our across revenue delivered portfolio rights olanzapine of nearly points categories. of XX provides from Lastly, Slide this additional the the growth of XX% product

like performance worldwide in XX% QX, The growth. early robust by saw growth cancer sales would to First, metastatic continued which positive driven Verzenio, the of indication. indication, is driven I in steady the highlight with breast by volume momentum

strong continued Jardiance performance, with its for quarter. worldwide growth revenue of XXXX XX% the

treatment in rebates. segment as higher was offset kidney the As you for with approved discounts by of estimates decline XX% mix was prices, the changes growth U.S. well at QX, in of unfavorable heard both revenue adults than we chronic by FDA progression. to Trulicity contracted by as and lower earlier driven risk periods as for In volume QX, disease in Jardiance saw more worldwide the rebates and

to international patients, Trulicity. minimize taken to to markets, new disruption measures we Trulicity to to potential affected start professionals, have existing patients communications health In be on volume not including by continues care

to Slide XX. Moving

to diabetes benefit strong quarter. progress the with X pleased be in this to make to patients grew more type quarter, the revenue continued $X.X medicine. performance of continue as million QX, just billion we Mounjaro Mounjaro. up In from previous from access over to $XXX We expanding globally Mounjaro the

diabetes the and with As of October U.S. including Part in for across X, patients. X in commercial for access aggregate XX% XX% reached type patients access D, commercial

type on diabetes. start the opportunity This for more expanded X access Mounjaro gives patients to therapy

last communicated expired program all we $XX card paid. the XX, quarter, since As prescriptions June on now co-pay consider noncovered

the paid As prescriptions as of noncovered card, $XX a scripts inclusive card. but of co-pay we the reminder, covered co-pay $XX those define outside

expect net percentage rebated also prescriptions, will will from We face improves. of higher a as to but to access price from continue headwind volume continue paid more Mounjaro benefit the

to we end in overall expect the to to continue forward with year, trends. increased of growth the access, see Looking prescription

agenda. terms supply, continuing Mounjaro progress manufacturing to In of expansion our on we're make

most for U.S. shipments on have inventory improved, results listed product continue as Given with supply wholesalers shortage strong U.S. throughout Mounjaro all doses which available of demand, the QX, we and levels to website. quarter. recently, impacted Most of increased now have the tight FDA experience of

regions. constraints supply With may at supply goal tight, device We're eased track have outside focus these online chain increasing also were remain the U.S. from end a year impacted high on shift supply ago to Mounjaro by listed parts outside of demand over While in our other the and assembly the production this are U.S., the each doubling in year achieve performance time. of capacity which bottlenecks the on we RTP, expected materially and U.S., production is is we to and continuing quarter. to of as are gradually where Trulicity

As with earnings forward around more world the faster. are Mounjaro in presentation we moving last call, patients different quarter's we mentioned to reach of

a in in with launch as introduction U.S. single and presentation in a outside which The a vial these starting single Australia to We the other of months. be serve click dose to expect multi-dose have a plan we weeks launched pin, to is in available vial dose will intended geographies markets in and coming bridge the XXXX.

tirzepatide a obesity for the for later of We're year. also preparing in potential this launch U.S.

to continues increase, and to look bringing more ahead. the forward output and tirzepatide months we capacity auto-injector patients years and Our to in

in an expenditures, allocation. In and XXXX, we capital billion $XX X XX, through of outlays. months our business on invested combination development On R&D we provide a nearly future growth Slide of capital first update the investment

dividends In $X billion repurchases. addition, we shareholders in nearly share to returned and

gross towards presents first items, the our higher for end unchanged. for estimates administrative of ranges in and note would expenses X R&D gross margin our XX categories. expense expense is the Guidance end guidance. marketing margin of that line we the top are updated and our percent, financial including XXXX trending I and for operating selling revenue, Slide

rate through These the of to equity inclusion charges, transactions business updates investments charges You'll that and potential we've charges and QX. effect updated the do not reflect include QX, year-to-date and transactions tax or for development of GAAP acquired IPR&D see with results future for EPS after IPR&D pending guidance. in guidance OID, associated completed

XXXX our results. We we report initial provide when will QX guidance

in to I turn to our call Now will progress the Dan over R&D. highlight

Anat. Thanks,

of across pipeline congresses significant areas. well progress therapeutic high all new had data medical the on we multiple quarter, of where we volume as at presented as a activity This our major products

multi-kinase cancer. call, RET-medullary the Starting advanced as we metastatic earnings or of Since for line last with from results oncology. evaluating choice Retevmo with inhibitors an announced thyroid patients study our physician's versus top treatment initial LIBRETTO-XXX

of standard at with compared we for patients initial These in medullary have the improvement thyroid properly or to data presented do XX% diagnosed. the care these demonstrating a establish of work are and systemic survival we to the endpoint, cancer, its vandetanib. progression-free treatment primary cabozantinib ESMO, Retevmo all of As should study and met to advanced progressive identified patients that RET-mutant ensure as

non-small We survival cancers compared October, progression-free also addition Retevmo lung positive LIBRETTO-XXX fusion-positive accelerate data metastatic III study recently to data, detailed or cell to at with driver profiling others in these chemotherapy published cancer. in selection. from the Phase showing We guide patients cancer more initial advanced genomic lung at will diagnosis hope that treatment ESMO to help lung for other pembrolizumab RET doubled in than shared plus

X to study high preplanned therapy The year risk of were in a node the MONARCH-E Also simultaneously Phase HERX-negative therapy, patients published England cancer early results LIBRETTO-XXX Medicine. of HR-positive Journal in at in LANDMARK of recurrence. breast compared LIBRETTO-XXX of the combination each endocrine New analysis we ESMO, results interim III from and Verzenio at with shared endocrine with alone of evaluating a positive

years X The reinforce the These endocrine is recurrence by breast risk years Verzenio the years. observed XX% of of cancer impact the of at care high-risk period, X plus of Verzenio for beyond well therapy treatment as X reducing long-term early treatment of standard data patients.

clinical that data in an agents be other study endocrine in endocrine therapy as single being combination in data settings AMBER Lastly, with agent new data shared advanced well therapy. breast HERX-negative we the a imlunestrant, studied oral with show therapy updated SERD combined patients medicine cancer. Phase be for III ER-positive as I imlunestrant monotherapy and could can alpelisib imlunestrant our backbone combination as in breast And the Phase on everolimus with in or first with included these safely cancer. future data from advanced shared of breast utilized in We cancer. important certain The hope

Cancer the wild-type inhibitor our agents Looking for, in KRAS triple Therapeutics highly KRAS. GXXD meeting at Targets preclinical earlier on is pipeline, data first, that we preclinical of pipeline on in Molecular selective potent our against a shared and data X shared October. oncology of new We

isoform selective high spectrum of a wild-type highly with a and against inhibitor. monoclonal common KRAS activity third, antibody activating potent mutations and And inhibitor, a the Second, Tobosomarase broad in to a pan-KRAS NRAS. anti-nectin-Xoa fully over human most HRAS selectivity conjugated

are differentiated the next the product These molecules enter clinic we target among potentially to over oncology profiles. focused represent year. years expect agents, create They work exacting to of against the

our and to affected CKD. chronic in diabetes for reduced the treatment the cardiovascular and portfolio. risk of III This adults EMPA than the by significantly treatment at adds we Jardiance million Phase the U.S. of options FDA Turning adults more deaths disease. XX announced QX, with trial, kidney approval obesity the of kidney to In kidney disease progression risk adults for kidney In approval chronic Jardiance of with the progression. disease in

call, III a October study published in clinical Since at journal. Obesity SURMOUNT-X the October, in the peer-reviewed with simultaneously in be from last from medical results These the subsequently Phase Also published Medicine. results results EASD. Conference the we in earnings results Nature we will the at SURMOUNT-X presented trial detailed Week top-tier presented

maintaining weight having tirzepatide these alone. tirzepatide Data be obesity of and continued diet XX.X% from show that, and to part for that Phase mean achieved results important of approved, those exercise up therapy these trials of management, for if with showed clearly The loss importance the participants an III detailed total weight sustained studies management difficulty from weight could loss.

have of as Slide on Our doses in includes XX, the since now exploring tirzepatide higher and a X type participants we NILEX obesity. Phase high-dose II in initiated shown study pipeline, tirzepatide with diabetes

In oral pipeline, movalaplin II. Phase on participants simultaneous lower the is I up we currently European first of presented data to developed of was LP(a) publication agent study, dose-dependent is in the the and Movalaplin Phase Earlier to specifically Phase with Lp(a) of Muvalaplin at resulted well this Jama. levels. I in Cardiology Society by lowering muvelapilin in XX%. in tolerated Congress

shown into acquisition Phase completed we We've also on I show of have in Versanis and II. As XX, bimagrumab our Slide siRNA our for no SCAP NASH. Phase advanced

potential combination the bimagrumab about excited are We of and tirzepatide.

pursue weight osteoarthritis. knee share to apnea Phase the indications simultaneous are that enrolling obstructive last for our sleep Triumph Lastly, earnings we're happy since now trials core III chronic call, registration retitrutide management, all actively and to

into with Turning review. to either our time neuroscience review donanemab are other Japan, XXXX, to us complete and portfolio. global to and The Europe FDA QX that needing additional We've completed authorities the has extend will submissions regulatory shared or their completed submissions in underway.

Recently, Disease from we a program insights presented during clinical trials in new session. symposium development at Meeting, the Alzheimer's donanemab

a evidence donanemab ARIA amyloid bleed blood symposium, pressure. prior factors association that we participants pooled associated strongly highlighting variables, including analysis included part this As baseline shared ARIA few high of most of baseline than with ARIA-E number dosed key with from across data X,XXX more explored levels, of a and risk, a a and

ARIA. this the suggested antihypertensives of also use risk data Interestingly, decreased of

analysis brain over patients open-label donanemab. of stronger These a Additionally, with of X,XXX and our even demonstrated we patients analysis from tow similar our with main X post-hoc than biomarker addendum included results TRAILBLAZER-ALZ treated salts study. no or shared

compared to In showed Alzheimer's in treated the many their preserved placebo, related unattended. to of daily a early make ability living the with left times disease, ability III to activities use with items appliances, TRAILBLAZER-ALZ that from separate post-hoc be of independence donanemab safely appointments, meals, to people Phase to and and we past more study, of people perform including their keep perform measured, analysis

plasma robust of validation performance immunoassay. identifying for our an amyloid-positive shared also our demonstrating data update PTAOXXX this patients, test We for on

a the to a test commercially have phased test developed as approach in of available expect this We laboratory year. first by end this

have TRAILBLAZER-ALZ recall, PTAOXXX participants now expect to an a we As a have presymptomatic X within plasma qualifying to results efficacy event-driven we and you trial. number is trial, presymptomatic identify use years. for individuals recruited and sufficient This X of

our in noted, begun Dave for to dosing as Akos in We're therapy loss. trial for who that to new that patients hope gene moderately happy approved hearing excited a immunology, we're the to the announce will severely for asset colitis can from FDA for an approval and are of Omvoh weeks. offer active Phase treatment Otoferlin patients have adults. in rapid effective available ulcerative searching today improvements. has lasting Omvoh approval option offers be In for the in U.S. to This I/II patients coming

readout disease to who mirikizumab to molecule, biologic X co-primary Crohn's year, to than and that previously therapy with see severely in patients in well demonstrated Phase through and to was Mirikizumab endpoints compared Crohn's III XX participants moderately excited the mirikizumab failed prior mirikizumab, remission for half as are Phase to all in active weeks. for have We III disease. this that the clinical of placebo. therapy. were study, clinical robust the major also biologic In participants response a remission efficacy who met more achieved were at VIVID-X secondary endoscopic thrilled seen as participants on naive We both

be potential colitis achieve successful Crohn's a differentiation disease. us for high bowel new disease. seen long-term remission of for the of important the builds key Phase levels and of basis submissions of help is treatments the with for clinical long-term our mirikizumab this goal inflammatory medicine. trial regulatory patients Helping for pursuit in remissions disease reinforce global olive data Crohn's This These will in III

assets, the our on a third-party I, Phase letter DICE earlier, DICE XXX DICE QX, FDA In issued now acquisition completed As the a pipeline, based at XXX announced IL-XX for the Dave respectively. we of and manufacturer. that complete X in noted findings response in QX, we oral reflect and lebrikizumab

II molecules immunology Phase new quarter. this begin in studies X Additionally,

our rheumatoid study our as for efficacy. inhibitor detitis; and Usimprubart our We've monoclonal the Phase to demonstrate atopic after second, from First, antibody, antibody agonist arthritis. in known IIa for pipeline RIPKX monoclonal BTLA our CDXXXR failed Phase removed II

productive at QX the call back for to for Dave R&D now quarter was turn closing another remarks. Lilly. I'll

Dan. Thank you,

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

as of growth revenue by to recently quarter, led course, portfolio accelerated Mounjaro. our product This momentum continued launched gain

the as of the in by the revenue portfolio COVID-XX Verzenio XX%, again and driven Excluding Mounjaro, Jardiance. antibodies from grew sale divestiture revenue well as of XXXX, olanzapine

late-stage in invest now phase and meaningful continuing well as to with continued positioned the III medicines development, Omvoh the FDA the years, ulcerative Jardiance with for business VIVID-X to pipeline well ourselves severely confident growth early for for the positive of have are of disease; capabilities colitis; adults for with opportunity launches, moderately severely expansion. recent coming achieved in our late-stage and Phase as in approval mirikizumab for the we the treatment We as Crohn's of treatment adults margin that with By coming active we to and kidney for as advances results chronic active moderately in disease. and

on approval and intended will to well portfolio. in several obesity. also are regulatory CLL, as to following of Directly for completed we tirzepatide an R&D our as before bolster mid-stage further QX, acquisitions Biopharma our in end In pertebrutinib, submissions forward, targeted responses which and the an expecting early agreement the oncology. expand for announced we Looking the accelerated our quarter, POINT capabilities year acquire we

Lastly, to $X we shareholders dividend. returned over the via billion

behind an In his our deep his end President for will Mike overseen after leaves X Lilly Obesity, XX our and company development diabetes from enduring launch. of compassion announced commitment his Diabetes patients at years XXXX Lilly. Executive Vice legacy Mike reflects and type tirzepatide's and leadership has A ago, current Mike changes. with late-stage President that people. and retire role, to of few Mason, weeks several an the we the unprecedented

from Mike's assume in to of his Labs in and will of President Scientific chapter Chief years will being Lilly Patrick. him With call, outstanding Lilly his Skovronsky, responsibilities Research the Lilly Lilly Immunology additional of for And service USA. the Johnson Diabetes to I of earnings last would Dan and Lilly life. of our role him to take wish thank President Obesity, current many of his like this Officer as best next President Patrick and on addition of leadership

related Lilly and And lasting move, Lean company of the role is Cusi, serve, full a the has to decided of over at Affairs many President from Hyman, in we're overseeing end assuming contributions David patients Lilly Communications, X XXXX. the portfolio. for Dan, the has on Corporate for grateful we and impact Vice Medical the past our Chief years. Executive for the leave company a the and Lean her Officer left

as more So and to of are our new of allow deep leadership ahead. growth this experience and we be make our company, chapter confident in efforts that accelerate begin to effective the our team very us will medicines more for to our continue we years innovative

to So now Joe, the he'll the let and moderate me Q&A turn over session. call

like We'd As for many and from a XX end Q&A to Dave. for So conclude Paul, please and provide timely to the call session, a.m. possible as we're aim the ready caller. we'll the in Instructions] the take as Thanks, Instructions] first manner. at callers questions [Operator [Operator call the instructions

is And today from from Instructions] Anderson the Wolfe first Tim question [Operator Research. coming

question if might know nothing therapy, and big persistence guessing I have A which but you idea. else. Mark. I on some has launched been have guess, best a obesity yet, normally think you I a have question, on

chronic is is of low? on other drug think I categories thumb in medicines. view, going the So therapy this that your -- the like patients is at your where drop to is rule most off mark, of be often XX% persistence X-year

who or X XXX took of you let's say, of if or drugs, still would many on one really, So likely X obesity initial X down on these be XXX how the patients years start road? contemporary the therapy,

therapy on of Mike, Tim. the in you obesity? to like weigh on Thanks, would persistence

Maybe tracking in it's for for going for period have, and that changes be to The we were Mounjaro that card best of patients X is hard data patients our time. Trulicity we started over diabetes it's patients higher have is on with Ozempic fall. that do to first to for same speculate what answer the because Thanks who the data started last tirzepatide those Yes. I'll those question. savings type obesity. prior than persistency on Mounjaro

it's out the project So therapy to XXX still couple a early of of on of too or how after therapy while years. many average be will length

this think is early I data encouraging.

tell. going time As is obesity, for to

I because supply at But this I at think constraints. Novo a point there's is looked market. all of we've And been don't benchmark think data. WEGOBI right this very dynamic the just

I a having think as persistency isn't said, this anti-obese on just issue medications, goal you it's chronic for treatments. for treatment all -- a an

what's different on about I impacts chronic obesity many is are that think treatments. treatments, any experiencing consumers stopping don't differently acute feel from

So clinical in some tirzepatide. seen their the what will increase SURMOUNT regain trials with feel they is experience that appetite consumers we've when and weight tirzepatide stop

should treatment And adherence. so reinforce this help

market people motivation. do is component a have want good people in Seeing to maintaining an tirzepatide program obesity lose weight they SURMOUNT going component, and is with to I see our think it I important weight just see weight you're how that And maintain important that to live use it, high do research, loss. a lost who chronic maintain we know our of it. of do for

think it's So but early length in there's in patients. do the obesity good of things a favor it, of rolling to tirzepatide having too therapy that's I project

Fernandez Guggenheim. is from question next coming The from Seamus

so much question. the Thanks Great. for

clarify into metering that programs. and just those was that wanted enzyme in I Dan, elevations. market Phase any could if you So there's really study to the related to orforglipron hoping drill I liver for III

diabetes II conducted. Phase the that in you case one was study there think I

Or forward associated kind expected to that? this know an related any on opportunity? of as and deck with if is wanted Just if there's moving all-hands concerns

forward Yes, all you We're it, Seamus. on the excited I moving like Thanks, phrase orforglipron. deck this hands really molecule. on way about

would before safety, II we of in what saw commented be liver what Phase nature for of trial typical population. we is that in thought think I this terms we In that probably

heightened into of of from III function. including not So for level Phase safety always a molecules, a concern, about all liver concerned variety but especially small factors, going

precautions studies it's orforglipron, doing the portfolio any Phase aware there. So I'm sure and in routine of but not function, III across special that our to liver monitor in we're

program that excited is super fast. So going

The from from next is Morgan Stanley. question Terence Flynn

Great. had Anat, early year. your shifting XXXX you call date guidance the mentioned of next

know manufacturing. what with change? to assure no if are and/or us you there And can want obesity tirzepatide that review issues Just that drove the

Sure.

start the let is date to there it provide year-end we decision behind have first So call. earnings full guidance to for results me it it does with the or guidance you have no What when does move are with XXXX. our help do aligned our reassuring QX issues us that

full So investors previously, had cetera, to this year internal our well. obviously, industry based that guidance into the aligned with believe enable planning for XXXX. as is have et a have companies to didn't at if and on And midpoint, It look the in view and most that. all then range processes we our us is the year estimates I and way companies, do close does

for So other nothing unique XXXX. set going data into that than full just the having

coming The Bansal from Mohit Fargo. next from question Wells is

It data biomarker tests, these with ever at like P-tauXXX pretty getting the was you regarding have is predictability CTAD. XX% question good. seems shown is the my And to Great. CXN

you -- to gets the to are bring you doctors it get do think how time? the be point, would or we this use to have So time prime test And some do this take when approved, could thoughts actually close this to? at any donanemab on, make this still

Thanks, Mohit, for the question.

little there, You broke I got up a hand bit I'll the Anne. we but to off think gist.

Yes.

and pleased disease. pleased saw. that also field diagnosis at is As in incredibly shared Alzheimer's see And to this drive CTAD, early across with blood access believe definitely we're biomarkers. progress we we in We the data important that to we the were

fronts, the but area. in number us with So others on own of invest tests also you've to P-tauXXX, seen partnering a elevate our who good are working

all boats. raising of strategy a it's So

a DT couple see think field the this phased is of did in make And expand time, good and with we in that what's We shared. amyloid diagnosis, gold in the us important incredibly standard published yes, is particularly share same then our year available the XXXX. starting intend which this publish in over But data. to the and end at sites of commercially is at but -- and you'll to PET, continue data, to the that we correlative continuing at approach a data,

So there. sure that that make can tests high-quality continue out have we we to

that's standard our test this set really look with should part to delivering a So of like. for goal what test blood is

hearing the next that available. to coming more more we data forward look So then and over make publish months as broadly that

the thanks, and question. for Anne, Thanks, Mohit,

is question from Cantor. Chen Next from coming Louise

drug you, why approval you I potential Why injectables? of want the diabetes pricing not? ask approval do impact additional oral or for think additional of to oral could

injectables. drugs for Mike of hand I'll diabetes proof over to Louise, on potential the Thanks, and, oral question. other the I about impact potential guess,

an will No, impact. class, usually, class diabetes that Pacific a new have in. coming within I happens we current I don't And diabetes fact, the competition mean, think see don't a of the agents within in class traditionally, market.

Mike. Thanks,

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

question. Thanks for the

Just outside But know a in on Carolina another if coming obviously, supply. North anywhere obesity plan near I have and online could and have you of tight. tirzepatide that, remain next demand one if look one year. you diabetes, guys had even what's modeled, you beyond supply and

like orforglipron that capacity? your outlook the near threshold is the how much will for have on manufacturing term is, of patients that? decision a on And So in the question inform treated there adding does

Dave. to over hand I'll question. the for Geoff, Thanks,

hours Yes. work Obviously, Thanks, a Geoff. multiple on topic. We this every hot day.

of agenda. deliver and in-market that made. a we coming and And of volume the the away site on manufacturing as replica a 'XX. Anat to -- exit is kind share we've its the progress on You're kind track in as online also few hours on that sort following we then of goal, made, great for which mentioned, track conquered, well announcements citing RTP on And year.

Mounjaro presentation our good Trulicity -- and the news in auto injector in presentation, U.S. the for call which what current know the the So that's is Irma you that we from

We've we're ex approvals on so equipment sitting access plant a single-use that we introducing about that uses U.S., by can that then different multiuse announced medication. than patients to basically talking we're aren't have vial the will what now previously here. presentation a and follow have property, injector and That

to So a things out. couple of point

made out new not a of kind noting deal rightfully site greenfield You're with big expansions, done We're of. those. we've

that the future. more I think hear about might you in

there from a current plan is rescue to take incretin do that from We need Of course, not to dramatically and that. aggressively we up pretty that to we this. levels, are parenteral supply planning on the banking and think [indiscernible] us

But that for is a vial talked a uses we've capacity which year, efficient is sometime the And to of syringe-based current than it auto-injector, ones in different us point And diverse there's injector, of we will from have as multiuse to will buying one, we as available have combination systems, in any one probably parties, have one, because be capacity going highly recognizing current agreements supply less probability a come next the the of auto-injector. full only already play in that about, much and the portfolio third-party ongoing the online are the those that background. not up systems. but third out here, from been then all

earlier. problem hands the deck is it's think I on every day. a all got, work really deck we've So hands all I as -- to this used mean and on

already. So we're not we've all at capacity python the announced

You'll see more.

now huge our ship. new we in for we volume in ultimately presentations just hundreds a for layer will of we we treatment like people. solid a the announce. obesity don't up to potential that role of course, given possibilities. term, to opens the global Some long key even need of more do millions impact But oral And medicines to then and everything can play That

the lot do of Thanks question. here to ahead. So for a work yet

from question from Laura Berenberg. Hindle Next is

into But forward, return Or you constraints should ex look into growth this assume as restricted. going Mounjaro? clear which still think the shift is Trulicity we in at did ease? the put the it's ex you're year results mix growth now I to that system about as rapidly should a Can we the for weak your supply think next is So quarter? we contribution U.S. progress. But moment, expect Mounjaro from how Trulicity

the Thanks, Ilya, the do U.S. you Laura, over for contributions going Yuffa, to question. President forward? hand Trulicity Lilly International. ex to and want I'll quarter address of Ilya in

to last Sure. had Yes, encouraged not start I healthy pretty transparent both first, year, thanks Listen, for patients. well part into due and of growth from we've the been we that, tight as with later think question. standpoint, physicians as supply, regulators Trulicity with coming new to we

right continue To to we transparent, that. thing think We with the do. it's be

introduce as looking and we as David incretin, we think capacity, growth the in of in other we Mounjaro have, as platform as and about in up and next we're Mounjaro. weeks the markets, multi-use transition the Australia Pen and Quick will months a build additional single-use mentioned, number both then we continue markets, file As with in towards over capacity, increase in in introducing

So we'll growth. able the the Mounjaro driven get where as by overall in new we to probably growth in markets, launch incretin mainly will are that's be

Ilya. Thanks,

Umer Evercore. from next Raffat from is question coming The

that have decision, I not about any? Novo are but approved cons obesity on realize price in you're very how I'm thinking VigorOzempic. there pros does curious know, and into as the you heading pricing premium, yet, Because if just is that Mounjaro

is because price you if curious I'm more into on the one on what can the So the be indication that. other hand, thought while But the offer could same. heading have this rebate dose same dynamic lot leave Mounjaro you we price a where the unchanged. just the is process it than the obesity can for hand, your

to I'll hand Mike. over

question. the scenario, to the We're decision for for Thanks make going every who prior approval. talk not Obviously, Yes. obesity. we'll with price to evaluating and live about right patients we're

is The from Risinger question David coming Leerink. from next

all Yes. updates for the today. Thanks

health to pricing. savings the on the So potential nondiabetic offer major criticizing focus that instead seem payers drug underappreciate population, broad some and obese incretins

nondiabetic benefit does of better ahead in morbidity about results and economic patients? Mounjaro's outcome to mortality So payers from in health the plan Lilly XXXX, Mounjaro's trial inform how obese

the a for Dave, about Thanks, do talk appreciation like longer-term the question. of tirzepatide? you the broader want medicines bit health Mike, about to little that, benefits for

that plan on internal a good and we've lot of of it's done David, spent and a ton time on. a a one No, analysis lot obviously of Yes. and question,

and question hard will whole payers so we short-term will do understand other We benefits. the they our because the they a of that impact, this real-world and have while have do sale pragmatic that about a payers, clearly answer budget losing for not understand suite trials that concern weight they're It's with evidence stakeholders. conversations In benefits are intuitive.

the If look at diabetes, the alone, there's in U.S. in see and And indirect when drive coronary X at billion X.Xx of $X medical associated payers you and their obesity there's annual When just with get obesity dyslipidemia. total comorbidities costly, that $XXX cost. hypertension, disease, some the look health on trillion and people normal rate -- over costs direct the does like attention. overweight it than heart over number stating greater these individuals, costs at you cost care obesity type like living with XXX. very then look of of are complications, these of And you

important This And for provide they're so functioning, the really is also, But will over impacts very disease weight goal their And to with think so a economic really materially to living mental in Their is important I time, think data. is continue and health of voice they someone's help obesity live we'll can obesity. that be long-term those lot in a health this. and who health have of I both that to lose and people voice going benefits. this. maintain with

federal a I the think as and both as government. well commercial insurance

time access. I that -- we do over am confident see I increase in so And will

obesity XX the to think medication. report in million I there's the U.S. shows that most has access people recent that

especially are do more will I that take it offer will medications, the more when payers get and them. think for time, we appreciating tirzepatide anti-obesity but value think I So approval

Mike. you, Thank

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

Congrats progress. on the

the of think October, now So how the given executive about the business the with changes direction we should announced immunology helm? Dan in at

take do Dave, Evan. want you to that? Thanks,

lebrikizumab ago. for see really solanezumab in here and of about, largely okay, next about the Phase you And a checkpoint lot now to hopefully immunology to II level. today what's advancing key ideas We've take I and be to important that's we into and a next I or comment. think a both decisions in can mirikizumab, in start agonists will and another that which business, Sure, this time new both pleased like set ago exploiting with long acquisition is going with next really to raise like What's tough take can diseases. form of the core view the involved either was years portfolio single been XX immunology decisions, [indiscernible] combinations it's here. soon and DICE portfolio really I that potentially I us, Dan agent care let had standard mean our internal externally, some of find to

in particular, We success. care this satisfied RA, low in IBD hardly Noting, the performance is at of today. as measure pretty standard and

the portfolio Genovese build So Mark that's and others, mission company and that the to Dan, to really future. we've hired the the of

you if to... Dan, know, want don't I So

the help work to in the lots excited really about medical breaking unmet immunology here. science There's No, needs is do and opportunity. of to

with come. market to to mirikizumab, hope continue and do So bring can and to I drugs to doing soon we're we hope great lebrikizumab we more as with

Evan, Thanks, for question. the

question The coming Schott JPMorgan. from from is next Chris

board? tirzepatide couple of we're we now? approval, Just how ramping commercial on coverage a we the quarters obesity coverage can of where anticipate in Just of as how thinking just X year think perspective think versus or about from in upcoming first be as interested coming should quickly it about launch could maybe your the we post

hand over Mike? time. coverage anticipation I'll Chris. Thanks, commercial Mike to to comment over on of

disciplined, on good as is make to we're ramp sure we're -- access be trying up. that a will quickly prudent. question. it's to No, It and we bring Yes. We'll trying as

we take judgment. use at has Mounjaro, access and that we so did materialize make it and pace organic makes sometimes we'll -- our an we'll And just where sense, with and sure like make to sure

just with long-term So most we'd while a to love Mounjaro, out get quickly, the for importantly as like gate setup of success.

they into of market kind of we with January, saw that last you when see product. you'll our So think where resupply, already a launch And capacity. new up ramp were -- quarter you the I any you important, go natural in look they a as would have resupplying it's first

access. I see volume a you at when you a as volume you our and ramp-up in year, our So access as we look think into in look head at our you'll ramp-up see next

Mike. Thanks,

is question TD from Cowen. Scala The from next Steve

considerations. know Lilly event interesting took the would adverse been Question on whether to or exact latter taints is there orforglipron, be And it's this risk or former, of GGG the of and the some reservation X pipeline, years Phase suggest some same to it's enhanced is III? why evaluating in has also about of There are either is Does It tirzepatide. the the which which to uncovered course, in higher molecule IRA doses way. safety get franchise. signals,

question. the for Dan? Steve, Thanks,

I'll Okay. of take all that.

referring multiple indications. which the We've both signals what sure about safety in and both you're III quickly. are lot in Phase robust those we're advancing invested not think retatrutide, I'm programs, III I orforglipron, reta cover and to on think I both -- a the but Phase quite exactly excited

there's So at there or hesitation no trepidation all.

be and to I health. those not in think contributors expect important which molecules, I human great X though to

if part testing but it dose have response It if yet. response curve sure want close, maximized explore II. we've the doses we so Phase dose We tirzepatide. hit and we the we like be looked might not flat of -- to the I'm the exactly we're higher in

patients for on a marginally we've expect uncovering think with sort this that had drug the of low. long I enough of signal is new risk enough safety extremely higher I doses

about all. worried at that not So

this. like Maybe just jumping in as we have questions here

mechanisms. related number We obesity search projects a of have in and

space that opportunity. idea one see our unique does to is we And shouldn't. not have people a some exploit single the as data a leader in We're we how we That's -- we're whatever. And and every which get that until says ask, this goal or well, ourselves effect insight in the this. pursuing really

the doesn't it And things. obesity. but have that, in is mode just all just so of above high of dose other read-through We're tirzepatide to another in a version

you. Thank

The Shibutani from Goldman Chris from next Sachs. question is

a from looking Can what get results? Heart be team trial week we'll detailed when that detailed us share so, results Meeting. the or In key at questions the X American about outcomes get you select cardiovascular will with perhaps we at Lilly the

to you weigh want Dan, on... do in

don't the here. -- that but course, add excited is, I'm see to line looked I guess of Mike as to some else top good. I data, maybe Look, has everyone know.

level I sort cardiovascular the think the degree of with connect now loss a weight fit. points of we're of data me, in on line the For creating that

wants that bodes in of I'll I weight given with data line to saw at greater greater That think if weight it loss shows Mounjaro degrees very MACE benefits, this Mike add. See high very well. point well fits -- that reasonably trials. loss, outcomes, leave including for the we degrees better on that. of which our fewer health in

like of drug Probably the probably was losses, looking question is by we're I'm weight driven effect at. question versus the effect how key looking at the much

Thanks, and Mike. Dan

Gould is from Barclays. question Carter coming from next The

the taken progress. on you question, impact flow following prior guys of of assets sort have Congrats your thoughts recent maybe the approach on more the and different specifically of data on your a there. the Maybe but sort there, with more

will benefits down population, that targeting of that targeting view you to the those segment talk about accrue is terms about think In just that the And Lilly's road. how class? maybe

Thanks, Carter, to comment data? for flow the on the question. Dan, do you want

Yes.

kidney I asking been be something into will members having This kidney disease. extend multiple you're and to and with that about expect benefit on mean class I it our per effect So fund here. that's really the now nice incretin additive as think is incretins well. important observed seem the is a

it's perhaps kidney. loss could control including exciting, in and metabolic think drugs, benefits, the and So other the these have to addition direct weight I

next The from is Frank from coming UBS. question

Just one on Mounjaro U.S. pricing.

the XQ calculations, by at net per is price 'XX, we So around Rx. our think $XXX

meaningfully your just to that give up the until above next Are continue price $XXX? ends? card For can can year, you thoughts for you now is saving net think for card this on there increasing? and the capped willing go this? saving net do the keep year, Or of price rest of that payers price to broadly pay if And can us

any do around Mounjaro John. make want you to Mike, pricing? comments Thank,

Yes. to be do No, that. I'd happy

to our kind I level, net of I macro think maybe would at normalized. that QX, in for Mounjaro gross say a

had of that number in dynamic. saving our gross then, that rate changes a card made Before we

and card Our at end late June. last QX, co-pay the change of in so occurred

say QX that we didn't we other changes. at co-pay normalized a rate any so pure And of And -- quarter was kind where card have would point. I that Mounjaro our

access, as is see that. related in what at But planned there'll pricing probably changes cycle, gaining be -- the to for out a point we don't see other of life card forward, future. normally Going co-pay near you'll that product this pursue I the what pressure in some you we think have any

Mike. Thanks,

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

for This Nicole Robyn. on is

are the the you through XXXX IRA on Just to and How decline going XXXX, we stays go obesity. Mounjaro prices impact Ozempic and in thinking frame? back if time

for Nicole, Thanks, question. the

and you I to you're that you maybe about IRA think impacts impacts do Mike, on semaglutide I Mounjaro. quickly? potential comment if it's to right, thinking want -- to heard

I'm the product happy will within an Yes. too have to impact really it's to do will have impact Obviously, class. impact how -- the that. IRA another and early

we that and dual-acting important unique X to it in And a superior I is both semaglutide. think in tirzepatide do results And has first did it incretin. profile. think is show head-to-head AXc weight type what's for the diabetes

the I day. negotiation, the obviously, at of go on of through that. in see so first the will with And of And we're profile end carry the product come the the profile confident the But to as the products the RA day, think we'll tirzepatide. more

left then Why Thank calls the you, Mike. we'll in through Paul, quickly, I think don't wrap we have queue. X X we up. go and those

first from Fernandez Seamus is a The follow-up from one Guggenheim.

the for Thanks Great. follow-up question.

what thinking how terms point? in of the oral mechanisms maintenance-type metabolic perhaps about would looking other that pushing in opportunity? see broader just oral regimen, the of as and set at Lilly bringing aid regimen here, of Or introduction of So do is treatments elusive for guess, in opportunity be could a therapies hopefully you're perhaps importance I a more pursuing, maintenance a you the

on comment to want you do that? Dan,

Seamus. Thanks, Yes.

sort So here. of all maybe -- the to Dave's of it's answer, an previous above

for the is obvious initiation monotherapy. the for I point of I Also, stand-alone yes, therapy. a think potential there's a for fact out also, great globally. as combinations. that And therapy oral GLP-X yes, opportunities maintenance on this therapy

expect, So of the dual it we it same against achieve oral, like will don't the benchmark But monotherapy. tirzepatide. levels GLP-X agonism best can with you I an see injectable X as

combinations like So will that. certainly the future hold

last queue. from And the question, Paul,

question last Anderson be a follow-up from will from Tim The Wolfe Research.

What's thinking analysis. is think, tirzepatide inform agonism by X have Whereas, activity you genetic go, is former have target. on drug I've the seen view? clinical your underlying is topic antagonism similar never biologic latter, to versus Amgen's that Lilly of antagonism? category the the Amgen latest any So a GIP of the drugs looked the effect, to their genetic supported way at similarly the says analyses opposing but GIP in

Thank you, Dan? Tim, question. for the last

Yes, that. I'll take

you tirzepatide, think, head-to-head we pure course, GLP-X, on which now, of GIP the GIP data study than the And starting is here is world have I with profoundly agonist. GLP-X can in also a It for to example, agonism tolerability. effects like limit effects combo see anyone looks the relative reducing Of against agonist side efficacy and and a course, that different GIP at, while efficacy looking more boosting tolerability. some

trials involved in our of that been thousands trials. -- on now So evidence that human tirzepatide have initial was patients tens of in well,

to went tolerated And weight could GPX highly a suppress agonist by could again, to GLP-X prove loss. led to about saw of do mechanism then understand out we agonizes that that that that creating actually we And pure alone. see what and system very just a GIP point drug we sort of vomiting with this what probably nausea the

everything trumps a of data we've human think I here, got and So ton that.

So excited like to GIP we're can't say both to it's with But unusual have agonism. will about what work mechanisms said, happen antagonism. pretty you similar ways. I really opposing in pretty

last one. Dave? the Dan Thanks, for

and your participation course, in call Okay. interest Thanks, and Joe. of Eli We earnings today's appreciate everyone's ongoing Lilly in Company.

busy As fourth been far, a momentum productive through year year of end and so forward I said, look to it's and Lilly a quarter. for very continuing we this

today. dialing And with the of the and care. day we the So everyone did on week IR today. you team not address has a follow call. in rest thanks for have up Please hope questions the if great Take rest of

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