Eli Lilly and (LLY) 30 Apr 242024 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q1 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, everyone. Thank you for joining us for Eli Lilly and Company's Q1 2024 Earnings Call. Vice Investor Senior Fletcher, Joe President Relations. of I'm call Ricks, Chief Lilly's joining Officer; me and Dave today's on Ashkenazi, And Chair are CEO; Dr. Financial Anat of President Dan and Immunology; International; Obesity Lilly and Jake of U.S.A. Yuffa, and Patrik Scientific President Skovronsky, Lilly President and Naarden, at Chief President of Lilly Anne Lilly of Diabetes Loxo White, Van Neuroscience; Jonsson, Ilya Officer of Lilly Lilly; President of Springer joined IR by [ and Mike Lauren team. the Mike ], also We're Michela Zure -- Irons,

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

cause Additional filings and differ results subsequent to contained the Form information that materially SEC. XX-K concerning with could actual in factors is our latest

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

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

Now the Dave. to I'll call turn over

Okay. with year in well our momentum and continued positions the which business, our accelerated pleased Joe. growth as for We're progresses. QX this results Thanks, us

a in in Our manufacturing pipeline including in innovative in XXXX. bring is to And of our this development, and expanding strong continuation medicines business represent investing the the through focus XXXX, capacity in network. of accelerating we're our people needed launches, to our growth medicines, people, we need. our new course, quarter delivered of Results

XX% pipeline $X.X We period with with new the to year. details in atopic active results achieved quick same financial of Revenue and to Crohn's mirikizumab sleep III for for moderately device in Phase in of III pen severely strategic apnea, performance of our for U.S. including QX to the tirzepatide EU evaluating and last initiation of moderate our in for several and Slide our grew resubmission lepodisiran, related the delivery On cardiovascular our and nearly the you key positive risk. lebrikizumab Mounjaro billion can obstructive U.S. severe to the progress -- the milestones, approval Phase products growing compared see X, efficacy the multi-dose reducing dermatitis severe disease, for of the Europe, submission study moderate in

We ground priority This top to approved, are ambitious agreement acquire execute ensure productivity on is expansion and We and in targeting demand. to facility Pharmaceuticals in to state-of-the-art XXXX. broke Lilly's initiate recently medicine working been to month manufacturing has in from we earlier meet to injectable site our we of manufacturing previously this facility announced FDA existing an Prairie, we on production Wisconsin. Nexus an Pleasant output end parenteral maximize And agenda. at the signed our facilities, are Germany.

recent The sites multi-dose progress for and upcoming EMA life lines CDMO and in markets pen delivery Lilly meaningful unlock the new and seeing other States. for quick our launch Mounjaro supply the existing will while capacity Europe of are approval for of also United we ramp in international new

our our against plan capacity, plans progress make to to most manufacturing expansion ambitious company's continue We in increase the history.

over distributed first we Lastly, billion during quarter. in dividends $X the

I key list you'll QX and since call, the a updates. On mentioned important events the including Slide other see X, earnings our several milestones of earlier

financial call the let results. to to turn over QX me now So Anat review our

Thanks, quarter of Dave. in the XXXX. X first summarizes performance Slide financial

product extent, realized XX.X% driven XX.X% growth a XXXX revenue in primarily increased from Zepbound. was and, by mix revenue benefited improved QX XXXX. the quarter from to percent to of costs. prices, Mounjaro margin XX% quarter First Gross and lesser a QX as Gross products, in higher margin of variable production new in

and the compensation as with termination R&D future and as prostate increased early-stage and XX%, assets, expenses driven of promotional as by in administrative additional program. launches XX% approximately research, efforts current driven increased late-stage investments million expenses supporting expenses development and well by the higher costs. associated onetime Verzenio for selling benefit a as increased primarily $XX of Marketing, well charge

we of $X.XX. $XXX increased EPS from recognized by million, driven charge in by QX, expense IPR&D which In impacted operating growth. higher acquired offset partially XX% income negatively revenue products, new QX Operating by

same QX compared tax Our XXXX. $X.XX QX, delivered XXXX, per in discrete We IPR&D in in QX XXXX QX benefit periods. effective with reflected period from acquired negative tax a XX.X% of the driven both XXXX in of larger inclusive earnings compared of share impact rate compared was to $X.XX a to net increase XX.X% the QX by in XX% charges

the Slide quantify U.S. by for Mounjaro and largely of U.S. revenue we driven increased and growth revenue volume our effect medicines dynamics. Verzenio. card X, demand growth. price, Trulicity, of Mounjaro QX in driven rate Mounjaro, on XX%, access prices and the led Unprecedented Realized XX% in Zepbound On to quarter savings Zepbound increased by backorders end. of at wholesaler incretin and

Moving to again primarily of was increasing Mounjaro distribution divestiture agreement. volume Verzenio currency, as in constant from with by growth as driven strong, the Europe. and well Revenue once XX% payments associated

grew for milestone quarter. declined base Mounjaro period. the revenue constant was X% in by currency. and the Volume decreased Japan X% X% and partnership Trulicity Verzenio, of offset Price volume partially growth by in driven in a

revenue [ in by QX driven Volume currency. Cialis China. constant and was to Illumina increased growth offset Moving partially ]. Tyvyt, X% by

driven volume lesser World Rest constant currency, by XX% in Verzenio Revenue a to and extent, and the of Jardiance. from in increased Mounjaro growth the primarily

Slide X our product perspective provides across additional categories.

the future looking to an increased in driven early Tekira ] which out. indication. First, million [ cancer acceleration saw QX, breast volume the potentially patients December growth even revenue XXXX $XX sales indication. I available to quarterly following increased read for making the sequential representing worldwide, in III XX% in growth to like We're more to trials as by approval continued Phase this medicine Verzenio, would CLO highlight worldwide forward

Mounjaro in release QX quarter-over-quarter in were QX million lower changes Access commercial established high $XXX estimates Sequential million $X.X communicated respectively. the in U.S. as for in across in from in the by we a and -- our incretin Mounjaro QX, from onetime XXXX QX earnings demand. call XXXX, $X.X injectable consistent channel levels impacted and billion benefit and for and $XXX XXXX globally, U.S., revenue as last billion -- and in was well up -- with medicines. with on discounts sales Next inventory in were as strong the parity and in

uncertainties is of The prescription facing of tirzepatide week, in their medicine. strong. frustration the each from yet understand or fill And those we scripts demand thousands for Zepbound people Mounjaro from and very hundreds yet delays

tirelessly remain are of supply the set even expect ramp we the track and the in half meet be expectations increases the meaningful continues In year. shipment least salable production supply. be growth will we We we doses to expect the volumes doses we to X.Xx saleable the second to demand working ship. half in earlier of 'XX second and a this increased can to on of outstrip While function XXXX. of primarily sales year, at of to in quantities second of half medicine incretin in the short midterm, produce The

was that are and under product Europe. recently Outside X as in U.K. year. from approval this to and management single multi-dose they device the applies This the we're quick week indications approval the delighted diabetes Mounjaro the to EU, approved earlier adding both brand U.S., in the delivery type

for to by in weeks. launch in While launching start country, the timing vary coming will we EU expect

dynamics. declined In QX, supply due primarily Trulicity decreased and revenue competitive by revenue worldwide constraints Trulicity driven XX% XX%. to U.S. volume, lower

communicated international markets in sales patients, to including measures have were disruption not addition, In minimize taken professionals we impacted patients start Trulicity. health new to care to to on existing by

Turning to Slide X.

in exceptionally rapidly building commercial in in QX. $X.X XX% in the out progress launch U.S. of approximately And X, Zepbound We have with we access for seen We're segment. access over the U.S. strong as for have April sales billion Zepbound

market is typically As a patients individual opt to rider require medicine two-step employers following an coverage. within reminder, in process to PBM anti-obesity a this

and access, focus We encouraging. and on employer broadening early progress opt-ins both to with PBMs for continuing are is

provide capital Slide XX, on update we On allocation. an

financial XXXX XX Slide guidance. updated shows

business Zepbound by seeing is of approximately billion at the the expected the $XX.X from between visibility confidence greater of business, increase production and billion. the the into billion our be remainder top for $XX.X and in range to to increasing strong the approximately core the global strength of XX% end continued bottom projections update, and Given impact the for excludes Mounjaro divestitures. the be the half With second and This XXXX. $X year-over-year year, revenue or and this we're XX% we're now to expected to on midpoint full extension outlook our which our performance revenue of of the is for growth in due acceleration year primarily company

of XX% in XX% ratio other on updates, non-GAAP expense EPS and QX IPR&D basis basis. reported results. the expect on revenue now we less of to be XX% $XX.XX guidance guidance, revenue now takes $XX.XX inclusive $XX a divided be further we gross into to and reaffirming these to We're share, and to a rate, range and OpEx income to representing per by tax update range consideration reported of on a the for in a Given which basis basis, Based of to QX margin and expansion. of charges non-GAAP margin now XX% $XX.XX $X.XX on to the on the expect

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

Thanks, Anat.

diabetes. from OSA. earlier That announcement known obesities obstructive this as results Phase of was partial OSA have from coronary for studies, with a OSA is sleep or failure, adults complications month. moderate X me upper III collapse and treatment which airway with Let our serious start type tirzepatide a evaluated to fibrillation the severe cardiometabolic by disease, exciting the sleep-related hypertension, sleep. positive apnea SURMOUNT-OSA to contributing and heart atrial stroke, even disorder complete of heart characterized breathing during can

more is impacts severe in to from people significant. million than need moderate people million U.S. OSA. XX with The OSA the suffering XX

with approximately a We obesity. OSA people live substantial also that XX% with also of majority, know

the are there treatments treatment potentially sleepiness underlying the with While pharmacological associated for could tirzepatide disease. excessive be first for pharmaceutical daytime OSA, the

trial. shown had participants Study run XX, at PAP patients while not for months currently two XX PAP for master the therapy on used As enrolled the were X XX therapy to on be A to tirzepatide placebo, of who evaluates comprised tirzepatide, separate and least prior for XX these were Slide randomized participants one protocol. pressure evaluated study course total of on continue tolerated dose or in to during X positive trials which milligrams SURMOUNT-OSA X patients the weeks. participants was therapy study tirzepatide airway or plans under in either Study maximum across followed or PAP XXX studies. to milligrams of Each can entire approved and

the of X. show results we XX, Study Slide On

events XX% per estimate mean tirzepatide For compared led were statistically This on and the per a efficacy for events to significant. reduction AHI Index, XX.X a hour X.X Hypopnea was AHI, in of baseline hour reduced or highly mean by arm. of reduction AHI values tirzepatide to was the mean AHI placebo. XX.X% difference Apnea

a of course, with was, We for XX.X%, body of which also also statistically placebo. saw rate reduction our this for expectations tirzepatide, versus This consistent study. mean significant

we XX.X highly placebo. weight of all a to events per reduction in was On Again, led population show the baseline XX.X% for Slide reduction saw per and events the statistically AHI tirzepatide of the These AHI AHI in significant. to tirzepatide reduction Study a AHI hour Esterman, The from compared impressive this mean mean X rate body we baseline. of mean was results were arm efficacy XX.X% a mean of with results also XX, loss X.X hour for reduction XX.X%.

generally both adverse the patients moderate reported commonly were in gastrointestinal to The In commonly severity, mild trials. the overall gastrointestinal events was similar profile tirzepatide and to reported events being and nausea, most vomiting constipation. for SURMOUNT SURPASS safety and most studies, reported treated adverse diarrhea, with related with previously

what noted loss of we about level see of that weight tirzepatide. readout, study we would combined the factors the to in given Prior questions several were study uniquely investor

the First, was study primary aim obesity. not treatment of of the

weight was harder loss can achieve males, medicines. whom with the approximately be incretin XX% to population in that Second,

And was the were We population. weeks particularly therefore despite observed XX- a dose there's approach. use difficult-to-treat across two or the see weight BMI loss population. high this XX reassured XX-milligram tolerated this baseline to the finally, maximum XX% nearly of highly studies in Third, at

XX. detailed did point, Consistent SURMOUNT-OSA weight with at not ADA XX-week III the June studies, other symposium tirzepatide as present see at We'll during -- to we Phase time of a loss results such on

midyear. to plan global and we other beginning Additionally, submit FDA the agencies to regulatory

first daily the compared in the to opportunities potential Apsetora year. coming adult naive Moving to ], basal pleased Quint insulin X with with share insulin. [ adults glargine QINT [ April Epcotora as participants of X which We're from basal and epsotora-alpa, select across the for our III in first Phase to In insulin diabetes to the other these type Slide results -- our XX X to Phase positive study line expect the are insulin. were who the updates type portfolio. Together, results shows that Slide are as injections. top pipeline multiple program. in events X study of key XX XX, insulin who weeks, once-weekly well degludec report shows This ] is of to QuintX we as compared in are studies III diabetes X evaluating evaluated X

significance. failure time-to-first endpoint obesity Jardiance all-cause XX% late-stage pipeline study, had diabetes risk due mortality or in both a in to which versus primary our orforglipron of heart reduction over [ composite participants, and in SURMOUNT-MMO results for ATTAIN-X completed showing management, with updates not We've and relative statistical chronic Additional placebo, participants. X,XXX EMPACT-MI include studies ATTAIN ], enrollment together reach the for enrolled hospitalization of the which XX,XXX and weight did

diabetes. retatrutide we've III in type X the program now Finally, TRANSCEND initiated Phase studying

evaluate In heart initiated have outcomes at lepodisiran, for to disease attack will participants excited A, trial the the III who the high cardiovascular cardiovascular or the siRNA. with This a subcutaneous cardiovascular Phase area, lipoprotein of improving we're risk inducible for efficacy stroke. have or in disease study

treatment health for We a due we increased to are the providers will a group primary of efficacy risk offer prevention. day high-risk this secondary both lepodisiran of high and option care in patients broad And X evaluating levels. LPA cardiovascular hope and

and Earlier our obesity diabetes obesity. a ], our now study II selective receptor agonist in pipeline, initiated Aloralintide monotherapy we've in evaluating Phase amylin [

prostate Turning Verzenio III cancer the hormone-sensitive CYCLONE-X analysis. of Futility, Phase the its trial following an interim to study This metastatic not quarter's to development to evaluating in oncology. We for endpoint. primary Verzenio made in the that following decision last concludes terminate meet announcement prostate cancer

In assets. initiated oncology for new we've development, early I Phase two trials

from The acquisition came our Therapeutics. of first is our -- Emergent which ADC,

oncology-focused team. particularly to [ to The annual second oncology this the to Chicago Sunday, our Point This with an details seeing plan more our and opportunities. what encouraged is sharing and via ADC We start, from an we're in conjunction the XXXX we take expect by three place ] We oncology hosted will and event [ be look available new PNTXXXX productive. by investment expect on enter Oncology ASCO the update and at portfolio came the of PNTXXXX We're ], clinic community pipeline Along evening provide year. in the acquisition Lilly Nectin-X which event molecules our least Biopharma. at other will also investor the to with of be meeting in June strategy on with webcast. X forward

Additional details will this be available event. soon regarding

to that announced Last Advisory symptomatic convene and Committee in Alzheimer's to [ disease. peripheral discuss the to the we Drugs FDA of CNS month, ] meeting early a Neuroscience. Turning plans denetumab

will be Federal meeting the confirmed Register. but We placed exact mid-XXXX, in expect date appears in it when the be will advisory the committee

], profile questions [ look expect the remain be We unique in to program. FDA's to to very of form. in benefits addressing with confident focus safety the efficacy along around this genenimab's the and of patients the potential and meaningful offer clinical to forward aspects We denenimab

our decision. still in have and in GBAX, gene been studies and disease disease this of investigation X. -- Phase Gaucher are type II discontinue to decision not impacted the X disease made underway we Additionally, therapy by type assets Parkinson's

the disease. inspection complete for FDA active with to moderate is This of application adults for mirikizumab use dermatitis. EMA FDA Crohn's resubmitted manufacturer. for immunology, on U.S., the lebrikizumab's severe In based the Finally, to moderately to we've following atopic third-party -- to approval a we've submitted severely and the in findings

clinical reminder, label. data the letter safety stated a As no the with concerns or package

expect action half this We of year. second regulatory the in

lebrikizumab indications: in Chronic be We're due also polyposis the well in advanced In squares. CDXX be be multiple antibody immunology of atopic evaluated we'll about rhinitis. Lebrikizumab two to an for the rhinitis announcing nasal our initiating these the populations allergic Phase into perennial new allergens. that II in treatment to important option evaluating in earlier-stage allergic dermatitis. lebrikizumab studies Phase III potential we've to biologic come in as for as We're be first Phase patient rhinitis III optimistic and will with development, months,

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

Thanks, Okay. Dan.

our revenue Before the product we quarter. first QX me let by Strong go was our growth in primarily driven to Q&A, and Mounjaro up briefly sum launches, progress recent in Zepbound.

of in and acceleration Dan top as revenue in tirzepatide from second of as and study, the incretin through advances include year supply ramp. approval in Phase EU, sorry well the mentioned. to continues data the expect our Significant medicines Mounjaro the We lecanemab as half just Kwikpen delivery from SURMOUNT-OSA, -- III of of growth as line mirikizumab device disirab submission initiation pipeline

We are long-term to upcoming expansion in continuing and and launches, This outlook. invest internal agenda. and external our development manufacturing growth our sustain to is pipeline recent

over Joe session. let the now So me to moderate the turn call Q&A to

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

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

I capacity year? overall you the in international? system faster the as be or a more more as you the capacity that new of on ramp question, on progress a than plant just or color, specifically guidance a the looking more just is little this Congrats just the elaborate the this leading And the to just U.S. read here. today. and you dynamics was capacity same could more are for I exit should had hoping bit expected raise we

guidance over talk about to to the hand Chris. Thanks, raise. Anat I'll

And question, the issued guidance, year, that's capacity we we've Chris. to expect and said what towards that second and of the half we earlier mentioned as the for year the in supply we seeing. Thanks when ramp we're

have reminder, to Now do have a come as capacity. quite that ramp online large our a number chain nodes we supply across of or

are in at up site if a just sites everything and the six they all look the North ] then between ramping that two either you Indiana, have we now We ramping are, in Arland construction, under have a two site Germany sites in Carolina, right in we or construction. under up, sites we one or purchased, seventh [

And which requires have chain on across cetera, et depending there operational, planned approval, that three runs year. to nodes product multiple that that which the become which are supply throughout are for products, line on

Now that nodes great these have confident. ability little into that year, we're X of a into into months capacity and the -- we more

one Kwikpen in additional slightly as ability our us of just patients of to expectation our the gives Kwikpen Just that Europe. in example, Europe in ahead the confidence approval came in launch for

as well exiting So across up we expand in sites as it capacity. up making or with our where sites ramp capacity CDMOs is ramping as or where globally we're as well to partners can investments

chain. our So supply it's across

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

I pricing. have the question regarding a

price seems at for how it look quarter. there you script adverse was you pricing we the if the year? of And like Can So relationship bit in that? trend, versus on about quarters a think the fourth over little should the cadence comment volume of the

Thanks, Mohit.

on You Mounjaro Patrik to say and assume but commentary it, I'll over some net talking I make Zepbound, didn't to price. hand you're about

it's When to Mohit. significant. important we into of at in a QX, Mounjaro much, the I Mounjaro, onetime that take the look for account in you QX very you earnings, that think quite announced was Thank adjustment pricing

onetime adjustment a the base QX. that of in So was

first forward that XXXX, card look mind until grandfather patients in the are half terminated that the important on saving of we for were X/XX/XXXX, also X/XX/XXXX. but we have it's When $XX to

for first be there So benefits well. half for half of expect see the from probably pricing Mounjaro year, But XXXX Mounjaro. headwinds would we the to this as should second during some of typical

from is from question next Raffat The coming Evercore. Umer

the second they and "weight differently And considered up may. Part sleep considered if quick loss D be D to wanted And a like Part will dynamics, broad drug"? a I drug" drug to tirzepatide a reimbursement? indications on an "weight reimbursement new not my I than is, applicable lumped will secure apnea, get as question focus loss

Thanks, go Umer. Patrik for to question. that I'll

Umer. much, Thank you very

assuming D. be the made outcome that's early that's we presented with trial, -- of I reimburse on our approved Part the and mobility-mortality later CMS with think going obesity study. ago April the weeks the just for sleep apnea, the announcement we're on readout new and in expect comorbidities with for SELECT And that comorbidities terms HFPEF, based also reimbursed to we other by in similarly Medicare the data confident to and positive that of

see and Still, not when. going still cost, to treat XXXX, our likely true at the it's likelihood and it's true to small obesity if, a north is strongly believe really it that reduce matter a get happen. but but to of we pass We in of that's a don't

from Fernandez The Guggenheim. next Seamus from question coming is

the Thanks Great. for question.

those forward opportunity So to really there? that is last perhaps expected likely assessed and that the in target of retatrutide in we're the you interested We've have speculation just wanted see right just quarter that firm had to to the the at move ask, EASL and comments Dan, thinking data, NASH they're data molecule trying of as possible the SURMOUNT or remains if about data around tirzepatide to those II are just setting I confirm. from when know Phase to lot for also you believe, if to and but up some a how

Dan?

Seamus. Thanks,

part accepted early abstract last be June. the there. EASL Yes, in So the I'll start presented will with and at was

So the that from full package that II see will trial. be Phase the opportunity NASH to

the last We exciting call, said some data. line. we shared the of really Like top in

II trial. Phase tirzepatide can It's this a effect I profound on disease. think have a

are the path here forward tirzepatide. what for the Next could to best with be FDA steps discuss

biomarker which data which That a though, profound of in likely of disease. another this retatrutide, we have You're additional from could benefits liver. glucagon, based pointing out, also to studies earlier have is addition has that effect in the molecule have choice the on

go with and to we have these discussions good options ahead regulators. So as into opportunities important

[ a possible for diseases, make ], to continue obesity-related related I portfolio, broad like has push other patients. science or MASH to pretty for Lilly and we'll medicines metabolic just the think the best

The next from be Anderson will from question Research. Wolfe Tim

You the slide, makes That strongest wins. in share at clear has showed drug of Rx it QX. pretty XX% market end a Zepbound of that

So they'll up topic, on readouts how to stack metrics competitor and upcoming sugar. on that Zepbound of loss thinking on just latest and weight blood your

So specifically, [ Novo and best but Agrosema it's I Amgen's do. it's just from we asked XXX. ] know the what to guess, get

Thanks, Tim.

it I'll Okay. hand Dan some for comments. maybe

Tim. speculate sure, more but probably It's since on Yes, of your a competitor at it job stab than asked. take to you readouts ours I'll

I really just small think XXX, we've of amount on AMG seen a data.

So probably their anything possible results. to you and is like be interested will see

that placed antagonism. with a there's about dual adding versus can different of ], heard like have That's agonist. sema a tirzepatide, be as [ course, Of bets, Cagri and agonism. GIP the pathways GIP we good course, . On is we we agonism of with more data our agonism what idea. got on arguments We've top on GLP-X

we've sema Cagri And that to advanced Phase amylin our agonist you'll So makes note sense. II.

already -- a triple here agonist we Tirzepatide more probably do at Lilly. could already a agonist. dual There's is

Phase across II, diabetes plus or Phase our are in III, more them to on assets of marked mechanisms course. have think Many of top established and could of in additive obesity. portfolio, I Phase two weight loss for we that I lead nine

for next I assets as our have has we're still generation strong So but we well. think portfolio at unsurpassed tirzepatide weight preparing a here efficacy loss,

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

the Congrats on progress. all

Lilly if representation us if can IQVIA help is channel? or if of that prescription flowing the tell you for was delta you given been And if can how wondering any much it is an underrepresented, tirzepatide Direct it's all Just and quantify underrepresented at volumes what you data know is us. through about accurate

Thanks for for IQVIA question, and Patrik Lilly I'll hand Terence. to Direct. the commentary on

we very When gaining with to utilization by the much, by the it And when consumers, it's we I pleased Terence. think Direct, traction comes start. here. at look weeks are very Lilly Thanks

that relatively Lilly data goes [ what It's it's by is low goes as If to QX, IQVIA well. direct, higher slightly we that through the a particularly at But place by captured of look in direct in not our volume estimate what has Zepbound, of through understanding methodology IQVIA. default MBRX Lilly goes TRx terms ].

The Tewari next be from Akash from Jefferies. will question

why team agonist agonism presented about like data preferred and GIP into versus when amylin at might a And obesity? looks it Phase amylin? Can last and but comes the monotherapy could you So regimen ADA versus are you a to your as II. GIP versus it calcitonin preferential your on maintenance be moving for amylin year, defer product how others talk half-life

Akash. AML. our hand commentary on to for you, Thank Dan I'll

in of good for there Yes, are a lot so questions there. Thanks following in closely.

molecule point as just So for mechanisms. with or potential on of benefits show agonism, answer around we or isolated that primarily you other molecule, of to in to the combination there's the experiment, for some that other indications long-acting I as GIP GIP, out, a think were excited the mechanism monotherapy questions action But tirzepatide.

since explore also already course, excited of to we're includes tirzepatide mechanisms. other But GIP agonism,

I is therapy, is a Phase So II. said It's perhaps forward explore. ], still X X that potential as has Lara as early a our moment perhaps a that's very the amylin. therapy, to ago we're as a for lot exploring maintenance of [ perhaps which the as mechanisms. where different to Move mechanisms, combination there's all That as monotherapy, long-acting a it of

and that. investing, we share, keep we'll to have So as we'll do

Huynh next Trung will be from The from UBS. question

wait [ ] appreciate do happen? Just when I ] that Could WOGOBI Or could But you the failure you certain this back goal. this be to govi do CMS we coverage on [ to in in data mentioned [ its data? Dror XQ? the conditions. a broadening ]? is get expect after CVOT the way for for Zepbound similar main And as have CMS over heart heart recently to add

Thanks, let Trung. Patrik I'll respond.

Trung. Thanks,

sleep assuming the early positive the April, for indication actually apnea everything goes of obstructive plan be our and Zepbound at then one and get third a assuming would we Medicare the covered get stated readout plans, CMS expect the And be approval. what MO that's for both. we next upon based Now time CMS sequence by And the would to one approval Zepbound the to and according of launch.

be The will next America. Geoff Bank question of Meacham from from

have this guys before, utilizing wasn't why just apply couldn't this means like been U.S. relieve I to U.S. to but sure Kwikpen in also the this markets the just could the forward? a I'm market and sure, be on outside asked capacity -- You review for looking can the if you rationale

weigh Thanks, you to question. Geoff, the want in? . for Paul, Dave,

to add Yes. Sure. I this. can Ali,

As the we to to the constraints it chain. demand of supply think need supply and above, tremendous all in unmet relates we've now, our is said that exist recognizing on and basically several the pursue goal as scaling options, calls the

existing Kwikpen U.K. and haven't other We the way a Europe to see was there so So the uses this now ruled needs jurisdictions. we assets, of in meet But as patients. time those in in first lag. it less out

of we'll And with at look we as meet patients to so every can obesity option diabetes. needs continue the as to with overweight and well

Holford question The Kerry is next from Berenberg. from

here. take to going different I'm a topic

found your confirm said you Phase taking III. data, published you whether the product, II you that into you're at any. now new -- haven't Looking Can Phase

at differentiated competitor frequency in you to you that looking as see be study? III. interested Phase So expect that dose what third Phase would guess be your we hear I'm be And of versus can III And when for you're might to drug already to and the that you if confirm I published? race, correct, how positioned appear in that administration

Kerry. Thanks,

question, lepodisiran. So to happy a but talk on Lp(a), about multipart good

want So comment do you to this? Dan, on

the here. for good Yes. Thanks, questions Kerry,

recently That You're received. published were haven't the right, well exciting really Phase But and II data. I publish we think we to data. Phase a just I was yet able

of trial. in very of deep things Phase levels very data the in the that Phase II durability have, long was people course, and that use now the one Phase III action think I our hand I following to dose a noted lepodisiran. in design single a begin in of reduction We and Lp(a) data a of

frequency haven't I'm time. yet, happen think I -- sure we quite disclosed in will but no that

You asked about differentiation.

Maybe effect that first we whether different are is cardiovascular and for differentiation Phase versus lead in couple much the threshold ASO floor in think there's Lp(a), to reduce of a to of know studies. depth benefits how a Lp(a) you of clearance into a probably I both have a to or this. there's potentials III to don't here shorter-acting siRNA outcomes

is one. depth of the So clearance

asked of here. be we're or linked. you secondary population frequency could action, studying the to primary durability as prevention administration two of being second, And noted as well third, the I closely those The of is being studied about, as that's course,

So with hypothesis multiple the here differentiation think good package for study. Phase to a and III have I Lp(a) opportunities this in we test eager

be will TD from from question Scala The Cowen. Steve next

you either based can only if anything And metrics, what survival that there CVOT superiority passed, all in non-inferiority? far? were have you already Given hitting the know available surpass likely benefit interim and confirm would simply the you is or a your stopped so eventually regarding can on has trial say based way that not the futility on confidence

Thanks, SURPASS-CVOT? Steve. want the to Dan, do question you on take

Sure. Thanks, Steve.

analyses, results, interim reason, we not different our prefer But of best kind to for of although many risks, unblinding do to about we analyses. trials the do you corporate that. do that on not of know, interim when talk comment unintentional As we our

primary noninferiority You're we the to and the and to that's that versus right ready that are Trulicity. good what cardiovascular be the a around drug reduces very know is design risk, analysis study of

as noninferiority trial. So a it's designed

we final be to see delighted even the superiority. data come, when course, would Of

confidence. You asked to increase about Confidence for this readout. our continues

but should confident, as that think concerns there et trials and different about make cetera. from males, lead And us we In fact, not could in and weight different of are got data to cardiovascular feel here I loss. the disclosed of sleep some additional loss the today, prepared study benefits, itself more females, the the actually benefit apnea, even weight remarks just populations OSA which

of some was that So discharged here.

So complete. forward and getting remain excited study's that look data when to the

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

that ADCOM to your you And wanted has addressed specific your this points will hope touch with asset? on discuss you in donanemab I the be experts. outside maybe the Can during these how will approaching. discussion -- confidence any if with changed

discuss to the you Anne, Evan. [indiscernible]? Thanks, want

very Yes. some and the to confident forward are in just seeing to that it people the we offers early the potential overall for Alzheimer's look And Thanks approvability question. so [ the do We disease and ] questions. with there's meaningful much fact benefits of incredibly package. NanoMab's

We haven't received those yet.

and -- I discussions very -- published consistent think of the presented. remain those what we'll around efficacy and safety really efficacy we is And that safety profile the anticipate and what with

there. new nothing So

stop important We and do clears chance We limited dosing. cleared around this is them expect of there's is a anticipate dosing we they'll rapidly. couple that think the when the donanemab, of unique an aspects you've to to our feature and donanemab plaques trial to incredibly One want duration robustly discuss.

dosing we think limited allows that this So duration approach. for

getting that it. do respond data really we and see advisers So into the forward having that look to and to

no tau, Another the those in of It's of while for so X we And that in that baseline. But be the doing is mention prognostic more tau the opportunity is disease benefited -- unique had able factor earlier assessing on even intervene all population, earned. tau important regardless tau that the the we we remain strong patients low biomarker to results. based his what aspect trial level didn't think with that understand people This that enthusiastic what the remarks, enthusiastic even saw such and and in to that field was better. [ one he of Dan those about early the about with remain tau saw I in with early was at reasons we ].

data part stronger are be slowing. in you preclinical. had the XX% could that we study probably believe earliest remember patients you think into patients that even And that of I our earlier a the the as get

loss. sure going continue remark. this sure health the We're ready. approval. In launch not one though, potential even make is is market into care to stronger time to with the meantime, we maybe that an We'll But system just make

making we're that have. to any said, comes So answering the they and most in mid-'XX, time that of look this questions forward Dan

Risinger Next question David be will Leerink from Partners. from

add me progress And my raise. the on and let guidance the congrats

if Or Nordisk Western of model about manufacturing out scalability raised XXXX? able should Lilly told the mentioned its how haven't meet try in world capacity guarded company the concerns the to community, I question orforglipron. global and someone orforglipron's whether expects be some launch? be Novo demand whether after on after about expect I or for is to building launch that process. know to Novo should investment ramp is in the could true. that's how supply discuss we, So in the to we but constraints steps directly, and has are please my you spoken they But for there complexity, don't XX orforglipron manufacturing me its given

Thanks, over Ricks I'll here. to Dave. hand Dave

small you I Okay. Great. Great that molecule, you. our in large there and to hear steps many all, complicated were, it forgone a first from the of small are a mean, molecule, if is is true process. large

I them about You can patent our read filings, in think.

But doing time. how Lilly, for defined and a made companies, We it. put orforglipron. do them a we've to we for to other molecules understand unlike capable small maybe together, long it We're of process got

extremely big is stamping because So the the tablet long -- The dry finish process to and processes, here, a process super something we're arms relative or were which are small around. complicated in API we just advance using confident really tablet molecules our production making, and is capsule well. understand maybe injectables other we're over have

and significant. be capacity tablet big making Earth is think for capsule the on chemistry here gain I there planet already the fact that and synthetic both that is will making,

and so access own partners we've commented be network API aggressively there's to as on side of here, well our or needs which production. substantial we a the lot built, can parenteral in doing dry capacity as as new been And product unlike where talking -- a earlier, and about not we're injectables

here. confident pretty So

in prove doses when be not quantities bit in We're every a guaranteeing Again, but in year after Now the launch picture on expect in that, can I exact we an quite stick will be the orforglipron maybe we the so important 'XX, studies. landing to and instance? the course think different safe Phase should a of that's effective III that's event class. incretin and that, and

Next from question is Cantor. coming from Chen Louise

can about like differentiate these And drug. you're about wanted just where you to a half you wave dozen in your you I development. next of obesity most yourself? think of do ask looks It

do the phase on obesity? Dan, you comment to want earlier

of Yes. portfolio Thanks, molecules. Louise. earlier-stage obesity We're about excited the

excellent of weight improvement for opportunities as of number a We loss tirzepatide. there's over an drug aspect. even think about like the one I quality think

example, see on even that's of as for like patients approved even these it fat with faster lean to improve investigation. agents stimulating ratio lose could So bimagrumab, but make tirzepatide, mass muscle on we the weight under drugs maybe we the

as side side of fewer Could that could taking have people drugs because have Tirzepatide and but easier find be effects? injections probably that some once Tirzepatide Maybe is stop frequent very but it even well tolerated, burden GI that acceptable, possible. effects. most to a with that patients for injection, manufacturing the less a make be patients. to lower on use weekly it could we

of avenue So that's another exploration.

even There don't their patients loss desired who are a like achieve levels some tirzepatide. drug of powerful weight on

another avenue. that's so And

Finally, could different more these across proved that different beneficial NASH, metabolic disease, or are indications, and less I activities there be of diseases. that other for related spoke related earlier to

avenue differentiation. that's another So of

probably diseases really of just area strongest with pipeline proud in I in the that what be that in and at all really investments what industry. I'm pleased that. abnormal the metabolism treating beginning must we're has the think and will come a seen as and multi-decade this be

Sachs. from The next Goldman question Chris from is Shibutani

Paul, the Thanks, Chris. next question?

you Can me? hear

you there are. Go Yes, ahead.

of like you're the communicate based broader timing dynamic you cetera, Previously would hosted that and I quite was could you and about the those upon Wisconsin and facility, happen that, ask and the to were that to front your supply been a latest that that something together? bit making, when supply-demand of not gave What's for to about Wanted might that a we in demand come in et you XXXX. two -- come specific you the potential saying of Dave, together? a possibly acquisition range. dynamic all in and group think closer a vocabulary closer little that progress

Thanks, Anat? Chris.

Yes.

me Let start on this.

the the prepared facilities supply said So a investments are situation clarify, for work expect as as quite incredibly the say seen the that will we just Clearly, the we that, our as working rapidly done remarks, sites right making it's M&Q did the in the overnight. of have I doing or manufacturing as progressing raise well year. production tight by have and and issue term my to you've proud midterm. colleagues construction well not that as progressing And we as near incredibly I I'm We're demand remain evidence in results would and We're the well, XX/X. world. around by the we

year, is both with medicines. safe demand even but the more And be will even with that, to demand provide across we'll and strong, the But but products efficacious through these supply a shouldn't health we year, Kwikpen. the I -- be go the through expect expect the that next I quite we time. we'll presentations, it add with that will different see. the the as that have highly that potentially supply surprise ramp could this as But and outpace and next into will as given well continue obviously, continue patients, auto-injector this benefits We'll to ramp some year, be invest significant year,

within have capacity different manufacturing available relief a globally. that our we in Dave another should which of earlier talked different We III orforglipron, mentioned, set of a about organization valve readout utilizes as provides Phase positive presentation, just offering terms infrastructure

be fashion. progress will continue update through as year we We'll a coming it the So years. investors to and in stepwise

question be Barclays. Next from will Gould Carter from

talk or clear loss you as not I composition move overall to across the Can the forthcoming. for showing loss importance of wanted the the the stat potentially. and weight to data dive III as a of the sig contemplate well maybe into bimagrumab blunting drivers Phase weight importance dose of bit ahead around Phase response a you IIb as of

question. Dan, the the to comment bimagrumab? for Carter, want Thanks, on you

is good in bimagrumab that think incretins, of important could but we be Thanks, a loss weight mechanism versus different incretins. It's question. combination Carter. very Yes. one with a

have likely muscle think we well as will bimagrumab, important as effects adipose on tissue So mass.

should fat bimagrumab combining by mass And is lean and of muscle to so ratio, say, I increased to incretins. our hope with see increased mass

semaglutide study, In doses. combination it's different this present monotherapy with evaluated boss being in at

So if effects on and previous incretin. combination work we'll we're seeing we'll see see studies lean effects that bimagrumab monotherapy body fat on tissue in if weight mass loss in stack, with

too. to seeing that, forward Looking

Devarakonda from coming is Truist from question next Kripa The Securities. .

And congrats your have about I all progress. the radio question pipeline. a pharma on

you oncology in And about that You market how so where of pipeline. share? mentioned placed you see terms what you've XXXX PNT see your this the landscape Can being ] [ in you seen far, then in talk advancing?

calling the radioligand Kripa, to PNT you our Jake, Thanks, opine a -- little question. efforts, on for in particular? maybe bit

our into happy with acquisition the are to. Biopharma, for really acquisition Yes, medicines to way through excited additional radiopharmaceuticals we Thanks bringing Discovery the of the make ourselves. that question. by and portfolio about We're Point supplementing of work the and these Labs ability

in about we'll of of have years in expect terms talk to more the additional addition next of couple over TNT I So to medicines the XXXX. course

prostate specific is But a stranded lutetium, versus XXXX more question, promise over single of a prostate lot cancer the creating think And that the actinium PSMA-directed efficacy and breaks double-stranded for cancer. for to in of perhaps for particularly patients while the drive conjugated therapy ability DNA holds the actinium, to altimeter. to context I

one I of existing salivary cause probably gland the is products. the that durable think much toxicity agents of be they too to real limitations

to designed order Point payload. as drive the a PSMA-directed gland so relative using And salivary in therapeutic index the increased to uptake more ligand the with tumor novel team actinium

just with now. right we're the experience So getting started Phase I

ligands there. that But to looked differentiated the yet. the PSMA So I don't from seeing package about just a we're have lot preclinical what out say interesting and other really exist

we'll we're see to putting and through its So we Phase forward paces, I looking have. what it

there's even maybe ahead potential exists the in the continuum to or in clinical think compete as the earlier therapy agents seen care. even prostate and cancer lutesium-based a of agent, in that go PSMA lutesium-based have with of the profile, patients I go outcomes that perhaps already improve expression really on Depending

as I. more profile the So come we to define Phase on in clinical the that

more one got we've think at XX. I Paul, time question. maybe for We're right

question So final a the maybe queue. in

coming from Okay. Deutsche Shin Bank. And from the today is final James question

with wanted and maintained. doses guidance just lift the reconcile being the to try saleable X.Xx I

the and I'll the those raised -- give talk relates maybe X.X comments. guidance to to how about not guidance Okay. the James, to

made dose the with start the let's February. So that in guidance X.X I dose -- comment call sellable on

a of up that not patients. number Kwikpen we sellable So reference the of Kwikpen, year as the ramp a is second the last or single-use to second for that ] has year. referred for device number dose but vial capacity doses. is half of this And recall versus auto-injector, the . [ available that Common unlike multiple of multidose that devices, half

half of were coming to the So these year. at will throughout are node X.Xx just second where Multiple has cetera, saleable our of the level remains least of on that unchanged. have each last in year increased. get That we will approved, in second But doses of we're half be There multiple our occurred. progress of the online these expecting or total have confidence we that's et year. capacity ability this

as the one occur, as example. will Some Kwikpen gave I

confidence well has to need as of guidance. across -- to in You construction et which concluded. as year least it start multiple the the approval, year, the terms our cetera. all site, There and are come and has a in construction year of are X.X. get But they as need confidence example, will online said Carolina, where for seeing our progresses, sites a think Concord North we run remains a to own Lines that become manufacturing increased, progressed, we that about we year and installed, but year. nodes operational in we'll get end of these the to That has by next at qualifications, need full of products external our

time Please company. in you thanks and have any team in didn't and you your day. if today, Great. Well, IR Anat. interest everyone, Thanks. a Thanks, the great that follow have our earnings today, we and up your participating call questions today's we appreciate for additional with address

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

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

may now You lines. disconnect your