Eli Lilly and (LLY) 30 Oct 242024 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2024 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.

Thank you, Paul, and good morning, everybody. Thanks for joining us for Eli Lilly and Company's Q3 2024 Earnings Call. Vice Investor Senior Fletcher, Joe President Relations. of I'm call Ricks, Lilly's joining me and Dave today's on And Chair are CEO; Dr. Scientific Financial Lilly and President Lilly Oncology; Dan Lucas Cardiometabolic International; Jake Yuffa, Health Chief Officer Patrik President of Lilly President Skovronsky, of Naarden, Lilly President Montarce, of Chief Lilly Jonsson, Officer; Lilly of White, and USA. Van Anne Neuroscience; Ilya and Immunology; President of team. Zierke Susan by Michaela Mike of Hedgelin, the Lauren IR We're also joined Sprengnether Irons, and

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

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

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

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

I'll to call over Dave. the Now turn

portfolio, On launches we and XX% network. our olanzapine Joe. our to and the strategic strong revenue continued make delivered We divested you after of see advanced deliverables. Revenue progress in XXXX. excluding financial growth, Thanks, Slide which X, progress new details In the of from grew manufacturing continued we business. in can product expanded invested expanding QX performance revenue our QX, we and pipeline, across related Okay. and to the Lilly impact

continues quarter. in doses in and volume direct sequential both expand Lilly X.Xx Zepbound saleable And a exceed channel has prescription the target LillyDirect's early Zepbound. expanded track on and finally, through growth compared U.S. incretin second the billion, to year. by of to for from single-dose at of self-pay medicines and and in and we half demand are the by the Zepbound supply pharmacy quarter-over-quarter was the solutions. The least access doses U.S. launch for this $X over further New order in channel, of strong in we supply. Mounjaro remain All wholesale the of XX% both vials production grow last year the as grew and U.S. QX. to available led half exclusively product second revenue access been Mounjaro of

continue our portfolio oncology, immunology, We the of neuroscience. performance and strong to see balance across in

recent in in the disclosure Excluding atopic the of Alzheimer's several from XX% quarter, evaluating portfolio, study the and growth treatment different Britain of dosing treatment and company for disease; tirzepatide and revenue for approval key milestones SURMOUNT-X from non-incretin obesity including of positive presentation olanzapine the the III prediabetes moderate QX. for X U.S. from of data of regimens of or to achieved Great Eliquis of Japan early of the the the Phase approval overweight; Phase the in XXX-week pipeline data the donanemab. symptomatic this severe with adults TRAILBLAZER-ALZ We was the III positive study, dermatitis,

Lebanon, we in milestones August, appointed innovative mentioned located over $X.X and our this investigational to the separate This our call, team the worked QX It Chief long Lilly returned Slide via $X first-of-its-kind updates. high-quality nearly portfolio. the develop integrin world. In drive key manufacturing has facility time, of the key billion design Financial will to Lucas. $X.X Morphic a announced agenda we underscores the several events XXXX remains priority. and investment be for investment for to earlier the has repurchases. short experience assets as since to of corporate lastly, our congratulations, This closed than to our and a X, and and the On for billion top our a Our develop to and and in including Montarce And and bring development the research Executive will In month, from shareholders This Last so invested immunology Lucas early Officer. President process years adding urgency Lilly confidence since announced And be dedicated to Board upgrade, clinical our we other pipeline we you'll Foundry. see the to phase acquisition footprint Indiana, Medicine to XX billion medicines medicines trials. I oral facilities to Therapeutics, headquarters. more brings manufacturing our Ireland. around we dividends and in patients billion. manufacturing Vice build, expansion acquire with Lucas a Lilly's billion commitments $XX increase we executive share September, manufacturing at commitment, also beyond total $XX

Now turn provide and update financial results let to to our over Lucas an guidance. me our the review financial QX call on XXXX

our quarter, across Thanks, growth products well performance financial highlighted our strong which Dave. revenue is Slide by as non-incretin summarizes medicines. third X in as new the our

percentage higher share QX than XX.X%, launches. Therapeutics. XXXX. negative earnings by of rights reflecting impact acquired was higher driven of increased the price, partially was for primarily growth. XX% from a of manufacturing acquired previously portfolio the with efforts underlying As $X.XX Verzenio. revenue in of nearly in excluding XX%, both olanzapine consistent acquired ongoing grew Other prices Gross and higher and the rate increased and and revenue by of by early acquired portfolio. driven the by per volume margin expenses by of Gross supporting expenses billion, the billion portfolio by after We Realized tax the excluding late-stage from XX% charges. On recognized after IPR&D XX% revenue growth. The from Zepbound. from driven mentioned, future of Marketing, income XX.X%. realized the olanzapine the $X.XX, XX%, quantify impact driven Trulicity, effective We XX%, our offset on partially from costs. R&D U.S. Slide from Dave $X.X to our driven rate, portfolio. And and revenue growing offset effect primarily olanzapine new includes partially of favorable the offset related Zepbound increased promotional selling, IPR&D, Mounjaro impact up revenue revenue the mix and was primarily QX non-incretin $X.XX primarily prices, benefited portfolio continued declines in and by impact IPR&D charges Mounjaro, primarily investment with $X.X revenue as Humalog, administrative unfavorable nondeductible in of and to impact acquisition X, guidance. tax Operating and volume of Trulicity. increased the grew rate margin increased by driven XX% this sale IPR&D charges. product Morphic provided XXXX we in to and expenses the U.S., Revenue by operating products, delivered increased a from of

Mounjaro While Zepbound demand quarter-by-quarter and by revenue has and and XXXX growing, channel remains growth dynamics. in impacted strong supply been

brand channel across continue complexities in supply to the Mounjaro decrease driven that when of saw of grew products. sales as XX% tailwind growth this impact higher aggregate high-volume use chain mid-single orders, highlighted impacted allow Europe constant Mounjaro, Verzenio of currency estimate products excluding by Zepbound Jardiance. revenue of a of olanzapine and was portfolio. of QX sales in digits inventory the This these the primarily We the a and we majority a to sales. In shipments percentage increasing we of as to divestiture fulfill us led by and to navigate combinations. QX, decrease As QX, the back different wholesalers inventory dose serving dozen cold wholesalers' as

have and currency, to XX% most We of growth driven with in Jardiance. by constant launched U.K., recently, Mounjaro continue the lesser Spain, the world grew in to volume be quick-pen Europe of Germany, pleased Revenue the now and Verzenio rest launches performance extent, in of Italy. strong in and, a Mounjaro and the

currency. constant Revenue Tauvid growth to increased by impacts favorable was driven volume Moving and of China. Humalog. This increase XX% for pricing in

grew $X.X product revenue Jardiance. Slide billion perspective almost uptick Mounjaro, of in growth constant provides Verzenio, our Japan $X.X of performance billion the with Volume XX% XX was of across Finally, net U.S. categories. and by Mounjaro in globally of in sales additional sales were driven XX% currency.

solid milestones worldwide population. onboard both in QX, revenue Verzenio collaboration was continued driven Japan totaling strong sequential with excluding uptake its early to QX recognized million. uptake $XX XX%, patient continue by growth breast of outside Mounjaro quarter-over-quarter in $XX U.S. impact million. increasing the sales see in of cancer and million. its sales When CLL the worldwide revenue in trajectory with increased sustained Jaypirca demonstrating We the trend, MCL execution growth $XXX continues to indication. the Jaypirca

progress pleased for We U.S. commercial the access are with our gaining

Ebglyss Ebglyss were receive in X also underway month. first-line we at access U.S. early and launch X for As The Kisunla this approval and and XXXX, PBMs. the of launch January major Kisunla have began to progressing, excited We is out of QX. the will

Ebglyss access by realized We are the the XX%, of partially U.S. lower pleased for volume, prices. Slide major PBMs. offset with by launch declined Zepbound. formulary Worldwide provides Trulicity to XX driven revenue update higher on one have already an secured of

continue sales trends $X.X We to strong of over to growth see leading billion.

broad Zepbound. We coverage for formulary have

opt-ins. making As ongoing our the October in expanding we employer progress X, Zepbound has access commercial segment, and approximately XX% are

for list We greater available XX% to the offering This obesity. at and U.S. adults other X.X- the helps of to more including in currently beneficiaries [indiscernible] single-dose incretin patients are through Zepbound, Zepbound vials of self-pay or price those Medicare obesity vials compared living in medicines and exclusively days are early access LillyDirect. the single-dose without X-milligram even launching a with discount

for year. XX, an On you provide on Slide Slide allocation. XX, we our full guidance capital the On see can updated update

a last our XX% revenue same $XX midpoint QX updating The represents are revenue billion billion. demonstrating to quarter $XX.X compared approximately acceleration. in of the XXXX year, to new range We guidance growth range growth continuation to

in lowering driver our markets we activities up our care new production This and are of range. of of into heavily for QX, increasing the demand support is with patients. In carefully top tirzepatide to be the the been scaling investing and and prudent have demand We activities. continuity continue for balancing end launches to generation supply creation

increase expect the incretin our second of second half saleable XX% half of We continue least in by goals to to doses that will the exceed to XXXX of we at compared production XXXX.

QX the the demand into there a in is flow-through lag with doses while and see of XXXX. Mounjaro activities, expect these to accelerate and will available, to and we revenue, Now efforts we all of impact Zepbound

Mounjaro we also internationally in contribute QX. to to launches new expect growing Lastly,

unchanged non-GAAP on $XXX of reported basis. and ratio income to Other reported be divided by of a million expense of margin million expected is $XXX expected now gross expense both to unchanged is basis. and range non-GAAP OpEx a revenue a and less basis Our on remains the a on in

of and ranges on range XX%, basis basis. rate is reflect $XX.XX approximately updated the updated approximately now a non-deductible by acquired have $XX.XX the $X.X IPR&D mentioned the through QX. to of earlier in Both to We impact non-GAAP to EPS driven our $XX.XX a effective of be as be expected estimated tax reported IPR&D on $XX.XX billion. QX charges well to as in

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

had Lucas. productive another Thanks, quarter. Lilly R&D

we designed does on the as months Slide that less smoother identical to titration result We increase were hypothesized our dose in standard donanemab of modified III dose as Phase some this understand total exciting were from we first updates, the phase vial shown could congresses. Let dosing XX. We administered X infusion but standard achieve to our regimen, X tested dosing indeed regimens initiation the In Starting in ARIA. the including modified from in a trial neuroscience. analysis, first we evaluate recent sharing trials at to we me positive Alzheimer's titration shifted amyloid we removal between late achieved their a begin similar see trial, this donanemab regimen. at pharmacokinetic some cumulative share donanemab pleased and result, achieved medical clinical ARIA-E. modified trial, And by data equivalent which dosing effect shared plaque the X of as the III Conference, exposure on different that treatment pleased TRAILBLAZER-ALZ this Yesterday, to phospho-tauXXX of reduction. levels to the in that which we results third, titration, by of for and Phase in Disease with

XX% also Importantly, regimen. we to hypothesis showed compared and those standard on of the modified for to titration receiving reduced the confirmed dosing that our ARIA incidence the ARIA-E XX%

We using and of plan As titration in frequency the supplemental for in lower standard radiographic severity a symptomatic regimen. all lower the to of well, observed ARIA-E categories was as carriers genotype titration. ARIA-E the of lower to modified modified compared submit ApoEX FDA BLA the ARIA-E, coming weeks this to dosing

fixed this stages efficacy of remternetug, TRAILBLAZER-ALZ III for subcutaneous a remternetug are design as more upcoming on we X trial potentially Phase for In study X, Alzheimer's where progression trying of duration Our we efforts are symptomatic at offering of earlier our X TRAILRUNNER of reduce monthly remternetug on the called we and We'll see to ongoing what share convenient preclinical to focused Phase a details the the disease, continue population. risk disease. III this evaluating study TRAILRUNNER registrational are we to genetumab, a trial progress, of starting tomorrow of option of CTAD. administration patient about similar

to insulin health. efsitora shared studies III cardiometabolic we our Phase called our Turning weekly month, from data Last for alfa. basal remaining insulin

efsitora X with and consists studies, registration of X a II As are is adults Phase adults type X with in type global reminder, in which X diabetes. of diabetes X

easier-to-use daily reduction relatively which lowered non-inferior using most type glargine. also insulin people These in with the form power productive people evaluating quarter in people versus look degludec, for were are AXc approximately achieved efsitora hypoglycemia are global inputs. In with results hypoglycemia who insulin incretin the that the AXc by reduction excited study III therapy in the QWINT-X, XX% has efsitora single-use achieved or significant are our low AXc We with XX-week an first results glargine dose weekly pleased just insulin the programs. met basal auto-injector. initiating time. type diabetes, We forward the for fixed participants' X.XX% X.XX% of just from with Phase that results of primary endpoint this severe to a clinically rates demonstrated for efsitora rates. insulin via hypoglycemia discussing used or insulin had basal meaningful In studies insulin been or diabetes, for the of the compared late-phase low X than impressive was highlight This particularly rates, AXc QWINT regulatory lower a frequently We doses administered program glargine. for daily efsitora which data reduction to each was with study efsitora with Actually, agencies. It X in its

severe this look the period, significant We and in or receptor that complications, weight a apnea, diabetes. related Week. These combined to including loss GIP of X data First, reduction III of shared in GLP-X demonstrated SURMOUNT-X and benefit type Phase obesity MASH, which reduction moderate or data in remarkable developing dose that nearly XX% week than the as This X prediabetes metabolic of type tirzepatide in to risk to developing sharing to compelling add we adults to the from longest-duration dual and detailed shown agonism sustained next we risk showing on treatment was pharmacology XX, the the accompanied study on XXX-week with of Obesity these results steatohepatitis dysfunction-associated forward positive by overweight, the Slide diabetes, failure. a tirzepatide achieved loss of date, a is X-year heart diabetes. encouraged patients obstructive the weight data more see a several and and are sleep results of of XX-milligram highly XX% at over

We of and more obstructive we quickly apnea for adults tirzepatide obesity sleep pleased adults bring fraction are approval to before with in expect for this we will obesity the this tirzepatide and to and end preserved regulatory complications, share working action with yet living and year, in with its U.S. failure we adults and ejection U.S. of that tirzepatide to obesity that heart with submit year. are

to reductions. advance maintenance body care avenue the patient Another of is weight

are Phase weight trials. X conducting maintenance IIIb We loss

tirzepatide SURMOUNT is dose which placebo. milligrams tolerated maximum X MAINTAIN, tirzepatide either The or first to compares

the or data versus IIIb ATTAIN look tirzepatide We placebo for tirzepatide participants evaluates semaglutide. GLP-X, in later study complete is line head-to-head sharing versus after second year. top of who orforglipron, this forward MAINTAIN, semaglutide the oral which our to SURMOUNT-X, The SURMOUNT-X readout

Phase lung the olomoracib first-line metastatic Optimus. Project FDA investigator regardless endocrine as after or III locally detailed the upcoming this study our trial The in of to results consultation submit by meeting. The a Next, in The imlunestrant expression. an the lung look patients cancer, diagnosed, evaluating at cancer advanced of expect HERX-negative oral in III imlunestrant abemaciclib. newly arms, GXXC with class this first oncology. Phase monotherapy, This is from choice we Phase the in results breast PD-LX of medical study underway, of was in combination and trial, metastatic III KRAS ER-positive imlunestrant sharing study comes to of X the the now with we an combination recently of monotherapy, portion for to dose medicine SERD, and second-line evaluated regimens forward year-end, cancer EMBER-X the on in defining NDA standard under care with Based therapy FDA with positive. medicines

believe look late-stage We this in agent continue forward program. and have to we could to the class leading of execution a

relief convenient to following the up Finally, dermatitis, by older recent than control early excited a severe disease significant who of XX% with lebrikizumab severe as that and of showing U.S. first-line for dermatitis. targets of X initial patients We eczema treatment. sustained shared children at offer years in Ebglyss compelling we're XX biologic the provides dosing to atopic long-term recently a cause inflammation Ebglyss to FDA immunology, moderate in responded approval atopic that with maintenance clearance treatment and and of treatment itch adults more with new Ebglyss main moderate skin to lebrikizumab for that provides once-monthly phase weeks. XX data years

with polyps. chronic studies allergic initiated Phase in also nasal and rhinositis III X of perennial We adults rhinitis have lebrikizumab with

October disease efficacy overweight outcomes. Taltz or autoimmune additional a associated risk with significant in psoriasis. and excited arthritis to patients, portfolio moderate ixekizumab help demonstrated X with in and the this late-phase We cover with plaque We diseases an more evaluating again weight of severe select I'll benefits offered Zepbound. Slide potential impact Obesity early sensory plaque studies the patients an Slide key sustained opportunities the III to pain. immunology phase recently treating As our study associated quickly of either tirzepatide XX for XX, expand to a neuroscience. and our by I've in we're psoriatic so antibody of when obesity progress epiregulin or psoriasis. Phase is undisclosed in already are an we for now conducting shows covered loss pipeline. see previously patients as for continue shows negatively and together has already strong increased had year. pipeline with updates And shown Phase XX we potential as chronic in and polyneuropathy. Phase neuropathic with in of arthritis mechanism developing Starting the I to pain can pipeline II distal initiated combined molecule for events psoriatic

from have siRNA our an Phase and begun agent. new studies on this assets, siRNA. X a anti-tau study oral our Phase also of we CTAD, tau-directed I II at neurodegeneration alpha-synuclein-directed detailed Earlier results disclosed morning We

data volume Safety follow-ups does clinical neuro impacts Alzheimer's for neither inflammation. in and symptomatic study on potential decline early tau slow ongoing. are While disease, pathology the suggests biomarker

coming to X the Phase in management study combination patients we with diabetes bimagrumab diabetes. in of In participants for study weight with with in and alone or II of combination X initiate agonist type type long-acting chronic a Phase tirzepatide days, amylin health. will weight without and Turning cardiometabolic chronic receptor the for management our lenti, tirzepatide II

starts. X very studies. clinical relaxin I be Phase [indiscernible] call, our year the kidney into new in siRNA long-acting with oncology, II advanced for did I a adults Since also molecules last APOCIII clinical as be the in it Phase we molecule continuing continues productive for cardiovascular meet new asset disease In bar not disease. We XXXX removed to our advancing will development. Phase into We chronic

combat inhibitor, this and to XXXX across of strategy clinical exceeding X to And earlier different outcomes. done or year PAN to SMARCAX our BRM bring to improve potential modalities, X emblematic and treatment new the new in put KRAS to patient oncology the shared medicines total KRAS modality oral utilize at Our least GXXD goal in starts X our These initiations inhibitor. therapeutic that diversification resistance clinic. we've inhibitor, our in X, we

sets this us programs we up deliver clinical to patients. expect early set of for slate for We programs as clinical will important exciting XXXX data new see which look differentiated an and

II excited in immunology, also Finally, to several we're early-stage new initiate studies. Phase

severe from which First, II we moderate in favor we in in plaque DCXXX, an is DCXXX Dice the And Phase pipeline into psoriasis. inhibitor adults XXX, potent Therapeutics molecule. of removed moved IL-XX the oral acquisition a with more to

and mirikizumab moderately Second, Phase we with II to in active severely altrecabart are a initiating study adults colitis. ulcerative combining

addition, In profile arthritis of the IIb this benefit the study terminating risk rheumatoid overall in Phase to the are parasolimab molecule due study. in of we

alpha-X-beta-X Finally, an after severe to reflects colleagues welcoming moderate now therapeutic we're MORPH-XXX progress Phase severe in Lilly for QX in we're for II our and Crohn's colitis quarter inhibitor, making our Morphic all to pipeline pleased exceptionally areas. integin R&D, to Lilly our disease. our oral productive for of with the ulcerative August, moderate and across was important patients

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

Okay, thanks, Dan.

strong Phase revenue well questions, immunology, taking We the U.S., Great briefly our Significant data as III and to in included for our the Ebglyss positive had Japan neuroscience Before for studies oncology, quarter. progress summarize for Alzheimer's disclosures dermatitis Mounjaro donanemab. and both in approval severe Britain, tirzepatide Zepbound pipeline medicines. our Kisunla of in disease across of and me as symptomatic and growth advancements early in and atopic let moderate

are We in future. Lilly's confident bright

our geographies Ebglyss. the through serve now of major have growth We the this of medicines expect Kisunla, in of decade. as cohort Zepbound, Mounjaro, That will Jaypirca, driver and that launched balance is we that

expect growth in our contribute these the of to with together already products XXXX. products, launched company strong We will

to support more In even addition, these we to and help across successful medicines scale step and the our to next patients plan up of continue year. to launches commercial manufacturing R&D investment

a session. I'll to Joe turn Q&A to now So over the moderate call

please call and the ready callers Dave. questions to Q&A conclude for from first Thanks, provide Instructions] the caller. the like instructions manner. timely take So many for Paul, then our session, possible to as We'd we're as and [Operator

first JPMorgan. question Chris from is [Operator today from coming Schott Our Instructions]

from XQ It results? kick to bit in XQ Can obviously help It's step-up sounds questions. the the is this saw just a reported part the accelerating to you bridge you're and sales. hoping little improved like implied we generation off sales to But just quickly substantial of Just in color can expect how programs prescriptions. capacity. you efforts, bit get those those demand now exactly are translate just to given on more I an what a a the efforts was acceleration

hand Chris, for guessing but I'll tirzepatide-related as Patrik maybe Thanks, is a the the to I'm of question question. Patrik? lot needed. over around since let Lucas jump in

much, Thank you very Chris.

I underlying took think a strong. than We it's also overall saw for approach first the when anticipated any we Mounjaro the QX, that the type in pretty are continues growth upon and our our market, Zepbound deliver we we of of in XX%. performance need a XX% of grow. important to service for accelerated That than more experience about obesity to much prudent by the to both and a supply, based in year X first driven investment emphasize faced the both center and than to customer the the And was a very market experience. half and QX for slightly been more good one triggers calls actually lot consumer of has more the

less down now are than those X% to being We of supply-related.

the strongly But on fully samples there. demand investing is effort, in And in providers. not we done the supply a heavily it's we're to are doing right all invest leaning to that are HCP in marketplace promotional haven't which allows what DTC we similarly, now we in the us efforts, providing also our issue. So past,

underlying NBRx we QX. both and So that Mounjaro are based a of very growth today remain upon of we good the trend and in Zepbound in after and terms the confident also TRx, marketplace the TRx

consistent growth just step-up you to the compared that add growth new XX% be throughout very fourth the we quarter the and remove the the drivers XX% advance we X%. of to that channel that. the the launching to you, is dynamics fourth just as countries we you mentioned, QX, that and mentioned. the that in will the step-up acceleration growth question. to a is When I in for of are acceleration as OUS Patrik to we with drive quarters, ones When that alluded so Chris, Mounjaro midpoint quarter. expect going for of add Maybe get the Thank at continue the that to part look that, well, are well that that Maybe

be Meacham question from from Geoff next The Citigroup. will

I that, dig into the so given demand mentioned drawdown guess perhaps I access? leading sequentially. why mean, investors volatility. guess, sequential demand you the to out if this lumpiness guess of related just want a just big XQ to figure such are I the you script would trying the to I a see Dave, of quarter? I it's are a the if trends in indicator moderation or rollout that,

Dave, you want to field that?

lot stocking. first there, to there Yes. Maybe asking channel in I thing give of a lumpiness us all, kind of macro you're is of a think

have saw forms That was in drawdown of this the QX wholesalers. QX. on number we dosage can Exiting have. our in with reached then recall think a we back we and and I that that a nadir probably of the all we had sell-side analysts as we a call supply order, much restocked pretty struggled in QX,

different reality really are and that their to control their decisions I want think making don't as downstream and XX retailers don't what to dosage attempt of the about is from Lilly own they we decisions but are to forms a constraints which customers working to Those capital wholesalers There financial to. maintain managing stock there their some are constrained. And in service capacity at that. Cold chain constraints, what levels. is customer are they're physical level. that

initiate last year. hand our point first never more is and on Zepbound. of we half we we had done in launched less sort how what before for Remember, the want to move have of much set of from in activities, think I started caused demand-stimulating we've which December we or stock go

as in-market our to to you factor make a I will launches you in consumption. add we all that we can is see, we're brands in and of actual Patrik QX that quarter accelerate to really earnest. Ex acceleration estimate we And as that, continue and is So about and here which, demand, think in over mid-November read just that data, yourself, by another doing U.S. guys or affects stimulation QX demand Geoff do moved out both buffer. sales U.S. see going we enough sure begin said, too, had

an when could it get So I trust that's for a And filled they to keep going forward. thing reliably. want customers prescription, that us think important

problem? macro demand Is So is supply actually. a there No, at here? a No. level, a there problem

Although if we had unlimited would demand, be. there

we as supply X carefully number. as growth I beat we're in going things we're mentioned, gating those to XX% QX, together escalate So the which,

us And demand our XXXX think really well. acceleration I see continuing You'll that's even stimulation about QX of but more QX as there. about grow and

We strong super business where this are. about but growth hoped. think choppiness quarter, So good Obviously, here some I was is underlying as would is as we healthy. there feel have we

Evan be will BMO question next The from Seigerman Capital. from

Joe, your job. congrats to on compounding. want touch on new I

headlines, hot on as you issue impacting do that secondarily, waffling so relates the kind this I'd that believe list the do you perspective. the shortage are Given love compounding? has your compounded frame how been drugs seems to of it demand? And It FDA's a

the there's see in. a topic maybe we field that, I'll that talking around FDA, let that, Dave hot I'll Patrik Yes, in indeed. Evan. about question then chime terms financial Thanks, of and whether impact Maybe broader the let

Patrik? So

So you very much, Evan. thank

market. X quantifying those know some probably comes of it there think it's mainly that is that believe are we compounding when cash to reasons a patients source the reliable off-label. I know, and not as and are to all

business. And by for here perspective, in U.S. or our to the from approved medicine efficacy actually the impact that people thousands with estimate of huge on financial of we So FDA our has not quality, concern our getting compounding driven safety is a be don't major safety been by there purposes.

our we been demand for has with diabetes. earlier, that in So the we drive mainly are concern, now, type as and patients obesity leaning to and said U.S. X in marketplace

too I the own other mean, have the But framework. their the to think going commentators they I have regulatory on, FDA's what's I more can't speculate mind. Yes. longer risk this that much really mentioned through goes

perspective and case, that care, do to guess ducks is row my is want they they putting I so. the and FDA an in they're There their they alternate, guess, about but think a so And this I to that is don't care. do win concerned

FDA capacity I'll X and work delivery is thing is heard API the haven't from itself. massively years communicate to capacity. here, could parenteral can that, more already. which part the capacities. the new invested you they to closely and do say schedule we filling we approve important directly. But that actually to of them a They're have not with to note take hearing for And this other with And we regulatory process big X in it's here we The anything

would So about to the we and it's unleash to be to with difficult think a to collaborate to the The delivery, product workaround should where is legitimate companies fully. workaround discussion embrace unregulated product. that speed world that up

that We opportunity. have be a the lot with up in of ramp. could queue impressive We things that already what now is or welcome FDA to would production speed an about

from Guggenheim. Fernandez will question from be Seamus next The

sense this with that up to house product-by-product scale. issue Novo does by the in that compounding if My the their question answer that resolved substantial of situation like get we'll straightforward in it availability oral can't having compounding this crisis? products, Or on is time? be seems such that the make that crisis. draw agency most the would at that with feel compounding move just out availability this resolve how end the can Once actually a It molecule order regardless could occurs, small an context, is over is of be easiest situation that provided and the you to

hand Yes, turning Seamus. our I you away Phase comments? back oral still from mean, agonist, would that's to GLPX ways to your non-peptide to Dave, course, -- the mean, of to referring market. I a our prior if what But III over ultimately add orforglipron, you're Dave. maybe then Thanks, I'll and coming

probably customers the because system versus long oral the Yes. potential of big filling said of of that with that way Well, are I billion run, mean, products production the there's we've the a a proteins. think And course, chunk I only parenteral those the of well is said, in served on X efficiencies I've planet. there

it's important. So

something as characterize be all, the need us. less the compounding lead what wouldn't than sometime like submission the see years to successful I first of want certainly crisis. from in that would data to we're for there a we put we launch isn't course, X orforglipron Of and It and X now. But and

harmed think a compounding. said, I so see people of really Lilly we Patrik And the financial like we are to duped, being right? problem of what and is on that's kind don't as stop. see impact But

that end for to as us if of to wants stop FDA said, an I then it probably reasons, creates think world. be should grows is the industry, sort we now, that the analysis. this reasons, FDA generic for that our public allowed at cetera, I and mass there. court, compounding state right product-by-product safety I is the be for worried continue, to and permitted. back et the in think should as good But tirzepatide therefore, do And they'll as we stay, not uses and be shortage think this that. At should but not day, the a of a

no that As not their for and ask, problem you demand about that, help we're with it working semaglutide increasing want supply reducing appetite. to although relates a to purchase hard by semaglutide to

maybe way. it that will resolve So

from will Fargo. question next The be Wells from Bansal Mohit

differently. I the if and can question supply demand Maybe question ask

some starting access, you will some between year. now -- thinking activities the convergence more you into part Do half are in How we XXXX? is there hearing about Because that the now. the generation that of So latter side of generation are supply the later it? demand be and you of are even access of some restricting demand payers it think the

are your at -- thoughts side, done on would that to the point. negotiations given you So the you understand probably I this access love have

Patrik to go hand I'll about access talk maybe updates Mohit. over and to forward. Thanks,

a on the just Zepbound. products into moving comments Maybe few Mounjaro

really Mounjaro, we where to think I are need across Medicare. XX%. good I have much we be and commercial we think with access and it's pretty And

progress to XX% access, terms in and of see Zepbound, here, continue time made employers commercial close terms improvement I think in of to In record we'll we've opt-in.

You are to trend correct, of favor is we in hear stories beat about some employers opting opting the out, major but medications. in actually the

the definitely X/X in I since new of We have And decisions the the we data XX%. in to XXXX are will part those think come. most effective are year some the employees of new first of making north

of our very, business So since in X but incremental are progress I have just California and most access Medicaid. And have we think make to we optimistic for for also very recently continuing connected we that and gained XX/X, in states effective part Massachusetts. last we Medicaid, time,

to us in are we and to now opt-in. lives, progress attractive approval that million help states more space. apnea, potential approval lastly, than I here continue expect XX big employer sleep with emphasize And covering the [indiscernible] make just So will would the of of

on the Of course, opens confident studies we back for access critical access April But gain employers. announced and up that also that are it will the and of in are with we top Medicare in that, year, CMS to convince we know out Medicare. that this outcome of door decision

with we well done I many excited the investments the we as access have driven across improved space by for think be as LillyDirect. about So have commercial reasons outlook to the XXXX, America

little allow see want we chime forward. -- ask Thanks, Patrik. OUS and I'll on see talk I chime to what going progress about bit to do to maybe multipart if like date And wants in you you and Ilya Mohit, about in OUS access though to you don't questions, and a didn't would even Ilya, access that?

have launches OUS. we our significant Sure. on progress Overall, seen

in share progression U.K., already in for of and share market and access Japan, seeing patient We leading those type of in markets have where our new we're both good markets where Germany, of places. in seeing some starts diabetes, those we're like X some the

our then drive we and good significant to the like progression already At gradual same continue markets. where markets. of and over to on both developed enter and leading there's the the we these And time. U.K., share access time, of of in chronic we chronic need pain also in market be we on prospects to other markets Saudi, about access pain diabetes access. the where we're increasing management course, also share develop self-pay markets. And UAE, as Of side, type both that feel we actually management adding but focus developing X seeing self-pay countries will penetration for And in continue have TRx new to

from Flynn The Morgan Terence Stanley. from next question be will

I I was know where of look out we can of framed would year. think bring you give XXXX? for second for supply XXXX, of just on new capacity out the supply half as to on auto-injector Again, how how progressing we been capacity, on an be this you've wondering, kind already us early your have especially efforts can you read and side should the the amount about that

expect then that frame and kind X a in. call you in guidance chance line then to capacities start, February. have space, can I be forward. this flow of time we qualitatively, full that that can backwards rolling to Lucas or year out go announced CapEx into But as and and and early the I we'll the we mean, you could years our lay so of our the jump see and on did in coming investment in

of we working we and next go expect to course, good year. you from to of 'XX, full announcement if impact. away 'XX, So are those couple online years made bring back an hard a this and 'XX, having are But year, growth those

acceleration we're and out we'll means seeing Lucas lay the details. that acceleration this So mentioned, on strong we but growth demand I in and for year, during expect total next the supply think in year,

Let the Lucas? me I get know have guide. to add else into that, if you don't to anything

moreso out good market and start TRx to quarter-on-quarter, trending Zepbound a year, provide my about to from basically that across Maybe both just see we the next growth in X proxy from Mounjaro perspective, of the on that than demand XX% and comment in the perspective I demand from When particular, to alluded more that think manufacturer. the we side more U.S., talk proxy the side. in sequential into so the the it's we side

Raffat question will Umer be from ISI. from Evercore Next

impacted? a just Maybe the quarter. have channels minute could changes in impacted were option to fees any in of the how to inventory out think I'm inventory or trying launch spend Could there going? dynamic the cash to that the distributors vial single LillyDirect via have the their given more out in And/or on incentives launch your pay loud. filling interest X is

I'll quickly that. handle let Patrik

ago. Overall, by LillyDirect set we month launched a just

with systems. quite I EMR time has in so and adopt defined to a system takes health it But limited are as that uptake, some level. the would we We pleased been realize low being of at far, also the their but impact be to TRx will the that self-pay say care single-digit

We not self-pay but channel significant to very to starts important a forward, in expect go grow therapy our moving QX. be new

didn't change our the both stocking in are and think the your short change of no. and we is We terms the retail any no questions don't think because auto-injector paid. I see answer to I

from will Cowen. Next Scala TD Steve from be question

a great shortages, unlimited market opportunity, experience awareness shouldn't be be concern DTC to persistent patient with my or a now. usually market awareness For competition. and for seemingly particularly supply about appears what signals really product Zepbound DTC, volumes in necessary,

getting competition DTC not due of months? if consensus what is the the Would Zepbound achieved? data over concern, ahead were out if soon? question is are the of XX be trajectory say, you So would the And instituted, be next,

on think answer That's regard first a we're just why with I in maybe doing unpack, demand his to kind to hypothetical But of Maybe -- speculate think this reiterate lot now. that don't briefly, very to Steve. point, around around a DTC Patrik, touched Patrik curve. we're I going .

half time just it first think responsible a the of second versus supply of Yes, that major in wouldn't consumers and some experience market, we are significant be at I half investments the pharmacy for We us XXXX. point any constraints. comparing to provide at faced very with different level. a the 'XX And drive DTC bad

and the to is drive more We now demand want a forward. have actually supply supply terms issue problem. that of we consumer this not awareness. just a confidence in moving opportunity, much And It's

but extremely is huge we here there market. very is obesity mind, moving is the forward. just to going just doing penetration X%. in at single-digit of And Whatever level, still activation terms well. a us drive can have to serve We we're why patient low a to in So well need do X% to

advertising. high brand we're that unaided just almost for not actually year very drug aware everyone awareness of this highly we call no add actually -- that is done a this and the would Zepbound, name, and although ago I on is have launched

time think to people doctor. I when to introduce speak the so they aware brand is their it that and So of are

question Dave Risinger be Leerink. from The from next will

Yes. been questions A number asked. of my have

that little hoping a color. respect could I'm to with provide bit just you parasolumab, So more

your mentioned it future? develop to I&I ratio. But see You benefit view the specific to any you risk And the due what problems? opportunity the in of PD-X for is that was dropped do disease safety another agonist

his Dan to Dave. get wouldn't worried Q&A a Thanks, I that And to on Dan hand over thoughts. this was I'll for getting so chance speak the maybe

and who the relatively It failed particularly question, was a was us, on for for the patients mechanism interesting Thanks a had Phase but really we good RA effect saw the profound Yes, excited Dave. IIa previous we in I data. biologics. were mean, symptoms small of when had parasolimib a number patients

the that study, replicate in out study that study. IIb. Phase on not to a IIa in larger seen start Phase we've when we that risk the Phase fully benefit end borne the So to came we out of was Unfortunately, IIb

pursue profile, to the that. on which both decided based of just drug, we not So and the safety efficacy the the includes overall

we're question a As have to we PD-X now. follow-on that right on agonist, X don't your pursuing

data So we'll full And presenting I to package that's what course, I'll say about at think, the the that. look of forward future meeting.

Holford from next be from The will question Kerry Berenberg.

please. question My Berenberg. actually for Holford Hall Kerry Vesneo, on

breast space, group. cancer, patient competitor broad early in your So high-risk Novartis obviously the recently approval includes in received this which a

would that with negotiation impact how brand then through you to high-risk So in and IRA can your to interested protect be you you position if And drug move just not XXXX. lift expect the that on the you share in next you about of D talk also a as expect the to year space, that efficient reform Part for setting. whether speak the or you market on your hear for be I expectations

Thanks, Kerry.

and potential ask but chime well to Sort X-part a in IRA. question presenting impact as I'm Jake? about excited as of to talk maybe Jake

for to Happy question. take it. Yes. the Thanks

of around pre-approval versus market expectation versus here sort setting adjuvant Our Verzenio the Kisqali for position hasn't to changed and share with really now. respect

a and X-year clinical with been with I critically patient recognized guidelines where adjuvant is a set, of scale finish for Those is couple proposition. I remaining on as over the months. the think lot weighed materially. past we of very over and It in treatment life, to compelling such move recurrence-free. That's which change regimen in of don't our follow-up on package important care. prescribers standard have guidelines Verzenio and E data expect for their MONARCH pretty of have hopefully population, I a has expert therapy population, high-risk their a can data that that prefer a think robust the patients variety of

but to market where choice, don't not as the a with adjuvant story a where course, patients used in us. And be and expect go appropriate I of market that that population percentage course, patients therapy of tell. for new the is get Of could up some in our who indicated, setting it I would And be will that's more entrant, any we're benefit expect we're is a a significant to overall and node-negative shift them CDKX/X that dynamics. inhibitor for whom there the Kisqali and

an it second the impact. around have your Part reform, On D will of part question

that probably patients, nets a where hard to tailwind where could the be out-of-pocket or I will course, of a see on how we sort downside there's of out brand have coverage here net in don't but think cap end sort it catastrophic that co-pay out. course, to up the the Of amount on being and on push it's out. headwind have I the to being tailwind totality, and in we a pull Medicare, shakes range. contribute know will for neutral of exactly It that particularly a think cap in

speculate all for list, we of On medicines of to to that. question I yet there that the your around part of actually be or just ones have negotiation evolving way nature different on another, given don't X be the up don't will think which the I information last say negotiation yet. want enough could

short running we're know time. I Jake. you, on Thank

just more maybe X or questions. X Paul, So

from Sachs. Shibutani Goldman be Chris will The question from next

calls. these to welcome Lucas,

believe a the forecasting use operating a of least Lilly term very bit and and know side, Just point amongst not just would I that aim clarify view, take the some curious, commentary your I operating margins, there's tension us the longer unique what for Can margin trajectory where your be perhaps would little on purview? is specific for. XXs you your maybe would of think high where And that between your precise people most at you of you suggested with percent. under sell a calculus approaching go that for

Well, ahead. Lucas, go

Yes.

the for me calling for our divided of SG&A question. your as talked up our R&D. we drive question, investments that those minus up to That have margin Sorry. quite Thank and ratio. to part do to into fourth run, Phase the sure see revenue year. Phase expect you, continue OpEx about for this to is short thank in grown That XXXX you of continue lengthy as XXXX, of the into quarters included ramp a to what portfolio the going just activities we we we both this our moves and as question will ratio. long-term that R&D. and starting will some in cycle In assets growth. We the having getting sustainable well down is our Chris, But SG&A in III and The we into ramp ratio been your out quarter to that expect will going growth that significant last II demand are is moving we investment, as into in you guidance. And your will will our our that have we up as by gross of scale to few about for -- new effect play pay see generation trajectory, ramp

R&D. on short would investments expansion again, That to would do In in long drive will the we to and term, margin in justify expect continue we ratio. basically some term, expand see that I sustainable we So SG&A the growth. this and that continue operating

will UBS. Huynh Trung next from from The question be

to discounts for you So changes for and rebates your Mounjaro. in note PR, estimates favorable

If it year ex on you gone look up the product. numbers, mid-single-digit Zepbound has for pretty you does ex destock, for pricing stable. like price looks if Also our out that

sleep on settings. mean have can apnea see HFPEF also just of for the what in into but pricing perhaps more about government you go next So rest evolution the the may that label, and potentially which year you'll you talk year you as

Lucas, sharing? you or pricing level like to net talk dynamics any kind of high worth

thank And questions. sure. Yes, you the for

see signaled sunsetting had, back so last in we that year, we Going will the the a little expected. that that program once the on again we price comparison tailwind the of of Mounjaro year the year-on-year were takes out that throughout out. basically to we we what that played playing to of And sunset kind year course, as that bit time co-pay far the see

strategy project to QX is getting QX, So that on into dynamics we basically of front? bit the would to to spillover see that. into Patrik, into little And what like sleep getting indication, major a comments in add, that year. you're quarter effect starting on see expect to any the fourth you what that see into you Maybe we apnea the of don't

Lucas. still you continue very terms of I in we that is mind will early stability launch. are think QX, I just would we we in And Zepbound, access. over have What increase in QX pricing, on to to need in say, the clarified

well being can the also quick-pen U.S. forward. We of with the pricing will now as see launches and moving impact global net dynamics approved outside

question, last up. wrap we'll Paul, then Maybe and

from today from Breen The will Courtney final Bernstein. question be

Coming just back placebo-controlled. kind I thoughts a get the MAINTAIN I kind note comparator. your And and SURMOUNT-X. to for obesity this back that of to longer on spoke the being that is to of the off ATTAIN looking term, little wanted trial perhaps you of orforglipron,

is future For of necessarily total and how kind just suggests which treatment, orforglipron a than talk this us, be an little product. about kind comparator of another market? kind could bit the patients, this rather you the of of of to being about market would that of expansion really the of obesity kind that duration displacement the Can of expand expansion

Patrik potential in Thank the some the Courtney, Thanks, the question to MAINTAIN you Patrik? strategy Yes. Maybe orfo. on commercial commercial for that. of ATTAIN trial. that -- hand for to talk about and noticing I'll

to significant opportunity much, the think readout lines an lines overall, along semaglutide. oral along looking of the going to Courtney. very are forward injectable, be It's year, the orfo first an in I we deliver here. III Phase But the that the you see trials next Thank But of efficacy II if the we with we a Phase saw of on XXXX. lines we

So will position I think globally. that us really to scale

impacts in penetrate that We once chain there are XX% experience the cetera. But We et avoiding needle you know to the also an XX% see the opportunity cold because tried U.S. a know in it, further is that the here if marketplace really it's even we requirements, auto-injector, with good. have but to we the of population. the probably

which a is you from disease, is to improve during doing patients patient clinicians we are periods a autos. And is our treat time, better leaning a think and And keep to to a on to chronic think injectables major you alternative ATTAIN in how I to the knowing a think to what That's can need our longer can MAINTAIN medication, and understand why obligation there lost I on outcomes. expect is for be some So is patients longer opportunity really X a don't we can obesity best they we're huge that expand. When on or side you is improve efficacious treatment we on time. with whatever MAINTAIN, see period the patients refer that on of keep there particularly on similarly, by disease. MAINTAIN, of I shift the to continue an chronic ATTAIN this

Patrick, I wrapping think Thank and we're Great. up, All right. you, Dave.

for everyone. I thank by Great. his today, just Head end Fletcher, thanking to the joining a IR us want a of who of Well, to CFO role, critical from call of you role as Joe on role new is Okay. Manufacturing. moving

and Sapar and the to ahead time IR role, business, after Lilly I all in actually as job it returning many to the will a your Street welcome years, rotations over point of think be the we Joe representing did various last great exciting Mike of into with agree Mike the contact. main an you

the have team to seeing And usual, for and Take as if all you the thank today. us over questions, road on you the forward follow-up call joining So everyone months. this at coming please give look IR care.

gentlemen, ladies for this X:XX conference at conclude X today replay midnight. will December through This made p.m. does And and today. beginning be our running conference at available for

system replay for (XXX) XXXXXX. the access may XXX-XXXX time access the can and your call You by any code participation. International entering dialing at XXX-XXXX. (XXX) Thank you dollars

now lines. your You may disconnect