Eli Lilly and (LLY) 2 Feb 232022 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by. And welcome to the Lilly Q4 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct the question-and-answer session, and instructions will be given at that time. [Operator Instructions] And as a reminder, today's conference is being recorded.

to Senior conference Relations. Vice like host, to now Fletcher, Joe President would turn over the our I of Investor go ahead. Please

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

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

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

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

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

now, Dave. turn over call to And I'll the

impact and of another delivered year FX in line top US LOE performance XXXX and Lilly. Joe. XXXX of We pipeline delivered commercial headwinds in Alimta growth a significant as the pipeline bottom year strong the and Thanks, remarkable progress. Okay. despite the of and for

In began cell in accelerated FDA of donanemab with lymphoma our assets announced in August, early last updates pathway, for we XXXX disease. pirtobrutinib pipeline. mantle symptomatic submissions approval QX the under the late-stage an filing multiple earnings Alzheimer's our XXXX two call to We with and

these received the a assets. months we approval month, both that deficiencies cited. at XX, of FDA XX complete exposure. January of limited on of other for donanemab issued There drug the On Last response were with letter least patients accelerated we response announced from to due number no the FDA

We X to available will will option to with to work pathway form make quarter FDA forward next for Phase the of this look application trial, confirmatory to continue and best III approval. which donanemab's treatment the the the traditional TRAILBLAZER-ALZ results patients for to potential evaluate basis

we coverage. access that, uptake has would this had time very expect CMS materialized. hoped submitted CMS to for from stated Unfortunately, consistently with medicines there these to Alzheimer's accelerated provide before movement disease. have people be supports yet we we limited would We for that not more At approval, the

that We patient time. this of FDA given be and confirmatory of should and positive necessary use maintain the reimbursement impact sufficient data and donanemab devastating traditional support global conviction disease to broad need, over significant for access unmet approval

inhibitor. may treatment with kinase Jaypirca a following novel covalent cell only pathway, extended selective binding inhibitor. refractory therapy, non-covalent at received the BTK inhibitor, adults for lines a allow Jaypirca, the or BTK January, inhibitor, and relapsed mechanism month FDA highly first and Also in systemic lymphoma of approval is two for BTK we of mantle reversible including targeting of pharmacology with a the is BTK least after for

donanemab. the with and approval are the opportunity confident remain for Jaypirca long-term recent we We pleased of in

to drive launches underpins current tirzepatide our progress the of of wave in outlook expand for to innovation our obesity. wave the of revenue We time. margins and two and new look along later assets immunology of forward top-tier mirikizumab potential growth and lebrikizumab R&D launch our this ongoing with next This with also year focus and our long-term over of

see you strategic our slide deliverables. made can the On we've progress on X

a antibodies, constant grew This business, COVID-XX QX for antibodies, Volume grew XX% revenue in growth performance again, XX% from year. our volume-driven revenue our last grew currency excluding Excluding XX% attributed for XX% QX basis quarter. COVID-XX in in core on to key the the products, and which and full year. was X%

in Jardiance for regulatory For tirzepatide and have tirzepatide earnings disease, US QX X initiation pipeline the a Track Jaypirca, important FDA milestones, of FDA approval we for and the sleep a designation Phase for submission submission several since Fast in kidney addition in EMA of to FDA Positive apnea. readout obesity, granting our of rolling the chronic recent call. acceptance shared updates adults obstructive in for with and the

to to We North Carolina, plans to create work we our Park ahead. additional value. the cash long-term $XXX announced Triangle for our expansion in continue January, manufacturing late put augment invest of to for to million flow manufacturing site Research capacity years an our In also further

our we into expand therapy front, focus capability we and strategic a the of a with acquisition development gene collaborations Akouos business new modalities research technologies. the On closed entered to on and

return shareholders and QX a announced XX% we we the $XXX we increase to via year. capital to the nearly investors. consecutive dividend dividend continue In to fifth the distributed Finally, million for to

of discussing several we list to development were and discussed including are that Moving during or December guidance you'll earnings regulatory, today X, key slide business QX important see our call XX. events the call, our clinical, on updates ESG a since

in low most collaboration Pharma of is -- middle-income within more an medicines. announced supply December manufacturing are for item provide to to capacity I'd to quality a low-cost region highlight to a deliver local high-quality we term. African Strengthening which the insulin countries, sustainable produce to with low long diabetes with is at sustainable least people will building and in in million company self-reliance collaboration of one high-quality the insulin important with EVA or affordable the One supply This like Africa. a in living

to Pharma EVA formulate to and fill a EVA API vials healthcare resource people, this sell for insulin quality novel arrangement, We're improving this proud finish significantly settings in to million reduced and annually access pro-bono transfer limited provide insulin part and a at With to be to agreement, enable XXXX. by our aligns cartridges. with XX XXxXX price will of technology of Lilly which goal living

to the full I'll review XXXX Now, results. call our to QX turn and Anat over year

Thanks on Dave. Slide financial focus year X and comments and performance. quarter summarize full in XXXX. my the fourth X performance I'll non-GAAP

currency XX% items volume As our Dave of by pleased QX affected report business core strong for we're to constant growth. driven a A on notable mentioned, couple comparisons. in year-over-year basis, growth

to in approximately which emergency Biptimozumab in no in first and COVID-XX XXXX. XXXX The any revenue antibody compared declined $X.X prior $XX the expect XXXX. million QX currently to use in not antibody billion XXXX, we revenue authorized COVID-XX QX is year QX to region XX% is for from US continue for

Second dampening XX-basis accounted continued exchange XX% of products growth compared XXXX, revenue is the for growth of and foreign quarter. point in Key QX. grew resulted in XX% headwinds to revenue a which by this our

revenue full from the currency X% grew a year For antibodies on constant or revenue COVID-XX basis. XXXX, X% excluding

logistics lower Our COVID-XX non-GAAP lower increase costs. gross sales an expenses points, due inflation and margin driven offset was to partially basis increased XX.X% in of primarily price and realized by XXX of antibodies, QX, by approximately

expenses. were Total offset milestone operating IPR&D and administrative higher expenses charges marketing, lower development by X% declined largely QX, acquired higher expenses and selling, in R&D and

favorable and costs by late-stage of expenses the supporting increased expense partially and administrative the assets, launch in partially expenses driven for X%, products offset exchange foreign by primarily favorable quarter exchange by rates. offset for QX, driven selling, indications, higher new R&D impact X% the foreign of rates. Marketing, by impact increased development of

XXX revenue, lower Full declined points operating and to lower X% XX.X% driven acquired approximately expenses. XX.X%, milestone offset income a in operating Operating compared impact QX attributed IPR&D by negative development margin QX partially which of for from increase XXXX, XX.X% Operating margin an to includes was charges. year was basis by XXXX.

tax bringing X.X%, was to full XX.X%. rate our rate effective tax effective QX year XXXX Our

XXXX. shared be during for we the our and expenses late in call amortization assumed of that in by As would XXXX research, provision requiring purposes development December, tax Congress we Act repealed had or capitalization, deferred for Tax guidance

related this range shared. legislative provision, resulted rate was lower the no taken previously effective a action However, guidance which tax to for versus XXXX in

billion. XXXX and $X.X X% earnings year. tax X% QX increased In in declined increase bottom-line in addition per approximately payments full share the our this provision for did the At by

across slide quantify the we geographies. eight, growth of On key effect revenue price and volume on rate

quarter US XX%. declined revenue This

Excluding revenue by US. led from in the XX% Mounjaro, Verzenio, antibodies, revenue COVID-XX growth volume-driven grew The was Jardiance. and swap

Net US flat was quarter. the price this in

in with US the price For line our in year, was the full of decrease the X% net expectation.

In for the driven to X% to Trulicity with business increased and continues in Revenue in Japan encouraged Europe. have in QX Revenue by Japan, Verzenio. quarters so growth remain primarily decreased in products in several Moving We the prior X% our Europe. impacted, constant decreased Jardiance by in QX, for Alimta revenue momentum of constant in albeit and currency. currency negatively patent lost demand less exclusivity including, than growth that Cymbalta. be volume

return We Mounjaro. to we to scale and growth year, launch key this products expect as

listed in grew for lower NRDL as well prices disruption. volume constant mostly continued by the as for result currency, products as X% realized procurement In was and China, volume-based on of as process by a revenue growth Humalog, offset the COVID-XX

the Korea this Taiwan. of of Revenue currency associated and Alimta company's to with approximately XX% onetime World $XXX by in the revenue increased in driven million of Rest sales constant the in quarter, the right

products continue points robust shown to As XX% our contributing volume Slide growth worldwide drive this of on key growth, growth quarter. X, volume

QX decline As key and was largely largely antibody offset growth mentioned offset in previously, XXXX volume, volume COVID-XX substantial from -- was products. in the and

COVID-XX While our our of we growth headwinds prospects the from Mounjaro. first long-term including growth prior similar pipeline through by quarters underpinned are and products key will antibody revenue innovative face period three XXXX,

key growth highlights the contributions Slide of XX, further our products.

grew generated XX% in these revenue. total $X.X quarter made billion XX% currency and This in constant brands sales of up XX% our or

high interest, see portfolio to and continue generates Verzenio including growth other products we While for key Lilly's percentage Jardiance. absolute incretins in understandably and terms, both tremendous

the remains XXX%, position, grew in the XX% in robust Trulicity a quarter competitive the on portfolio Mounjaro by strong incretins the remain driven product additional in bringing for and in online globally. meet an our leadership sales we the for demand capacity indication. Verzenio this and focused of both launches. Demand US, to globally sales upcoming retains grew edge and market Jardiance mainly

intermittent and demand There Mounjaro of of and delays been guidance in terms in call incretins in certain for at strong US. and mentioned products. have levels wholesalers receiving the doses as December, Trulicity pharmacies In supply, given our

on his doses the to We continue the to timing. FDA situation, been has the affected FDA and website regarding expected details posting update and

production meet our announced look where later Carolina this North we these progress incretins ahead. of years substantial plans have to efforts, we and proximal the this RTP as most rapidly continues The business, add side to in year. demand of additional, To capacity our growing across the is forward start planned

XX. Moving Mounjaro's underpinned experiences. uptake Slide to profile, differentiated continues, and positive customer efficacy by strong launch

XX% For incretins new QX, diabetes are approximately of class therapy from switches further to the of starts, and injectable Mounjaro's Trulicity. patients XX% X new type

mentioned We impact X diabetes time we net to at could QX call of took early our reinforce in that volumes, by the new revenue. program, Mounjaro type these As negatively QX but November, in savings use intended the in prescription were earnings not actions actions to we that impact patients. indicated expected

As anticipated, late seasonality. with of prescription we in actions impacted new the volatility by driven volumes week-by-week were by some November end these believe beginning year

payer diabetes. build for type continue access to X for We Mounjaro

Xst over across commercial Part D. for patients January AXIS of As X diabetes with just type and XX% stands [ph]

Regarding paid the percentage of scripts.

be of paid prescription approximately XX as inclusive percentage estimate from XX cards, script card. For to non-covered XX% but with co-pay the the defined those covered paid the Mounjaro of co-pay QX outside script we

should we scripts paid expand access, proportion to the continue of payer increase. As

capital business a In On slide XX, provide $X.X growth R&D billion future development through on outlays capital invested of investment. to we update expenditures, allocation. and XXXX, drive we an combination

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

remain to priorities and in launches, patients. shareholders our drive through investment and top-tier capacity life and through dividend unchanged manufacturing to our achieving our payments returned We investments changing our allocation innovation repurchases. speeding And R&D oriented and medicines capital are strategic development. revenue towards do share deliverables capital Our through to we new portfolio in business future of growth in current this

updated the guidance provides XX from an in result in made provided an updated financial EPS Slide guidance. update range. December is rate, only which to XXXX The effective we tax our change we've

XX% from the for December $X.XX During on rate approximately call, deferral in tax deferred and given place XXXX, action $X.XX basis requiring based tax XXXX approximately to this capitalization to our effective results our take provision assumed the of we and XX% the basis. to in updated EPS to tax the was or repeal and be of would we new guidance not repealed $X.XX R&D. will Since on a around when have on that in range effective XX%. provision such rate uncertainty shared a XXXX if or tax non-GAAP GAAP update This rate $X.XX of

rates our year. last set a since Regarding general initial there has weakening FX we been financial the dollar guidance of XXXX

we're FX and at one FX However, quite as changes adjusting not the guidance only be month year into volatile. time this for markets can we're

pronounced in antibody December, comparisons XXXX. growth in of shared sales sales. This XXXX most headwind that impact XXXX will QX $X.X will the in I significant in had given be of in revenue be antibody XXXX the COVID-XX As most versus year-over-year we COVID-XX billion QX

the growth Still in of antibodies. of midpoint core US for our XX% Alimta first business growth To in QX represents the roughly XXXX will of year-over-year guidance also revenue XXXX of half a our COVID-XX loss lesser of XXXX. impact range the excluding or X% growth in extent the exclusivity

This we and current of for patients on year future potential innovation. invest holds wave progress us to to tremendous our execute help commitment in promise while as maintaining the launches

We help top will through investment drive this ongoing execution XXXX. on growth revenue and expect disciplined focus two

to Now, to pipeline. our the an provide on update Dan, call I will over turn

to productive for Thanks we diabetes Anat. year We Mounjaro. tirzepatide, and of donanemab, for type Lilly Mounjaro mirikizumab mid-XXXX. a late-stage really key We assets obtained XXXX X was lebrikizumab in advanced approval our and the pirtobrutinib, submissions launched regulatory R&Ds. for

week this received if which we By as for launch mirikizumab our traditional now of Phase will ganitumab, also with for approval. two the new the As an year, for known our Jaypirca. have of Dave mid-year, forward shared, and positive end to last the assets immunology looking form submission potential lebrikizumab. we approval basis And pirtobrutinib III to readout we're

wave weekly entered insulin III on of Orforglipron have Those we Phase for next will that soon diabetes, and our registrational in remternetug our December breast have obesity. or In in Retatrutide disease also trials. call, SERD in now guidance XXXX, and are diabetes the and shared as gained clarity Alzheimer's enter assets cancer, our we in

opportunities last updates slides for the key I'll XXXX. today select mid-December, and progress key just we since a Given January show provided pipeline as XX and call. shows recap XX highlight earnings Slide briefly events in events of of our XXXX XX, potential XXth and

XX% with of in disease, to-date. kidney trial, SGLTX in showed III with progression the kidney death broadest The shared results disease the in a trial significant chronic diabetes CKD of people Starting by Boehringer largest we Phase benefit as Jardiance, reducing with Ingelheim, results placebo cardiometabolic in the relative cardiovascular inhibitor and from with and risk November, compared or EMPA-KIDNEY disease. in collaboration

submissions to of previous and other in were the to We've over months. profile The a well-established the to million XX coming for safety of consistent overall data approval with and the agencies safety submitted make and CKD cause affecting people leading U.S. FDA confirming XXX findings is Jardiance. worldwide, expect globally million death EMA in the regulatory

weekly five the III X a With escalation to diabetes dose In study of fixed QWINT program patients. insulin-naive in underway. January Lilly's are in comparing studies Glargine, now Insulin type insulin Phase started Phase initiation this we all III QWINT-X,

Lp(a), cardiovascular earlier to into pipeline, lower Phase Diabetes we stage assets II, Moving atherosclerotic to and factor aim disease. our in risk that for advanced well-known assets two a in CV QX

that between uses and molecule apoA particle production to disrupts small and liver. a the siRNA the of lipoprotein protein the inhibitor, in oral an second the is first The the apoA disrupt interaction the

XXXX. Investor our advance II We ANGPTLX to following December Phase proof-of-concept data siRNA earlier during second in Meeting. our which XXXX on our is II, entered to asset This Phase siRNA, the R&D shared siRNA asset

an Phase recently disease siRNA in into also I. targeting moved asset ApoC-III cardiovascular We

improving is Our the remain genetic medicines about molecules. we portfolio prospect and optimistic outcomes advancing of cardiovascular these with

the course discontinued for molecule forward our pleased In years in continuing recent we of the and inhibitor. development I approval the we substantial Phase KHK look program ahead. of Lastly, oncology, Jaypirca with the to we're ongoing

emerging product the includes is Loxo acquisition, in Lilly's patient. reshaped shown our Oncology oncology our assets our first its which efforts growing second Lilly. number XXXX now our NME FGFRX of which pipeline, approved Loxo recently Jaypirca dosed program a at portfolio from including at

the trial our will III second in Also, dosed study Phase oral the for imlunestrant we first in SERD. QX, imlunestrant, setting. adjuvant in EMBER-X EMBER-X, our patient

five a As adjuvant with received in to of therapy of HERX-negative monotherapy previously sequential two ER-positive for cancer breast years patients who endocrine increased risk early recurrence.

Verzenio. Lastly turning to

interim early of Breast of Symposium with endocrine shared adjuvant positive an population. we FDA monarchE, to adjuvant noted abemaciclib risk the patients for indication sNDA potentially Cancer As our therapy latest in analysis HR-positive guidance the now X greater treatment expand in Antonio San study high-risk breast at December, We've node call to HERX-negative for KI-XX XX% adult early indicated than submitted combination the the cancer cancer our of high currently the beyond breast with Cohort at recurrence. US our in

potential looking the first expect in half of year. approvals for lebrikizumab In FDA in we in and which mirikizumab which year immunology, colitis, of dermatitis, we're ulcerative we second year later atopic in half the forward the the expect this to

earlier in in initiated the for call, have ACR exciting pipeline, in agonist mentioned arthritis results our peresolimab presented study. immunology we dose-ranging now a our Phase proof-of-concept and our November Looking in conference IIb as at global we rheumatoid PD-X antibody guidance

our this Pharma asset Moving to PXXX rights neuroscience. regards from We've II With acquired advanced early XXXX. inhibitor donanemab. pain. Kasei for Asahi Lilly in into Phase chronic to to

for XX cited accelerated FDA by submission at exposure. drug a of efficiency sole least months approval number of to the the was mentioned, Dave our with As patients

predefined donanemab with II accelerated trial was their plaque patients clearance. approval allowed a which the course Phase of amyloid based, when complete The they application treatment on level TRAILBLAZER-ALZ reached of to

dosing as that plaque six reduction fewer more treatment, resulting as stop Due in patients early to receiving months were or saw, donanemab patients we of able XX months into many to of dosing. the speed

in donanemab Alzheimer's look and remain Phase this III with a to confident symptomatic potential as forward sharing people disease We TRABLASER-ALZ-X the treatment of in early QX from year. the study for new results

on work year. make medicines look XXXX pipeline patients. summary, outstanding additional we in was we're the providing updates potential We focused year the an next reality a to for to of In throughout fully to of while set our progress, forward need do XXXX

Now I turn call Dave. to the back

Thanks Dan.

growth and let Mounjaro XXXX. move we strong revenue progress growth to the while two our in the rolling patients products. propelled a study launched during key business, for We We Q&A, chronic Before of with summarize expanding of submission our we type for program advancing core outcome delivered for by me development the our diabetes, management. SURMOUNT-MMO made tirzepatide, the including start and initiation weight

Phase we XXXX, lebrikizumab. for advance received we've XXXX, in and approval applications regulatory assuming pipeline submitted III the study. process like poised and for In data the positive And products TRAILBLAZER-ALZ-X important are to regulatory from Jaypirca pirtobrutinib in donanemab mirikizumab, already

invest In we people. addition, pipeline, continue our in capabilities our to our and capacity, our

Finally, $X dividend to to in key products, revenue XXXX. we by share and business a Mounjaro year, mid-teens including announced growth consecutive the in billion our XX% the for expect fifth repurchases. dividend and Taltz, we returned core And continued With XXXX. and shareholders increase for via our Verzenio, Jardiance grow

launch to long-term us by success. launch this strong We our are key no opportunities energized the and before execution is year

make to together, through for XXXX people well to believe mission deliver at Lilly's we the Taken top-tier positioned world. that life better we and deliver least around revenue to are on growth

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

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

Bristow Thank from [Operator ahead. first Please Instructions] UBS. is question Our go Colin you. from

the morning questions. taking good for and Hey thanks

on Mounjaro. first Just

equation, out mechanisms XQ. XG in you price beyond So, of course gain helpful. through to obesity the just drove the sort side like interest future to dropped sort the on Can target be coupling how it you just trend have your to to portfolio, of the of the in any looking of looks walk us update would maybe the and the us this of over what expect that year? [ph], just that specifically you you net And XQ mitochondrion Thank do then this,

Thanks, net for question first Colin. obesity commentary. gross for We'll kind then Dan price mechanistic to broader and go and the Mike? Mounjaro for hand to on of over to Mike

the Yes. Thanks question. for

take the supported XX% aren't and the of about Mounjaro that kind a way at think saw quarter, then Mounjaro by patients as will In think in savings classify our fourth we as we I non-coverage best scripts defined as we to what QX which answer paid paid, look over progress scripts to that of $XX our how that program. is we 'XX.

people was In launch as access. living program, at our savings to type X diabetes with to designed we bridge discussed

from benefit to didn't As diabetes. a are it's earnings are used card adjusted our being non-covered We we discussed seeing any included X cards these we with this of who living expire type adjustments for on make people in ensure, our for to call, for removing June adjustments the savings only $XX year, XX. These patients. QX have program set June new existing better patients

As expected, of volume, with formulary start these reduced a percent have patients patient the new of the diabetes with and coverage. percent increasing treatments new history while changes

would are patients product. of from focused the for of is that think kind we and now now graduated do have normalized a program, you a cycle in program program at covered savings way savings I that, kind new bridging the would our on the type patients I look of right really of

in value approach very remained maximize short can long-term value. paid make we expect we've increase so the a to and term our scripts script as that We our net discussions value and access we per to that disciplined access on starts. thus XXXX, grow of new we sure start, disciplined continue percent the and revenue in we the to Mounjaro's remain that. versus long-term From our capture increase So through was

where this on out D diabetes where over and point. the just have contracting the way and turned access segments We're for type in X front very We Part living at for lives at with has we're our XX% access commercial pleased people

in Thanks. hopefully to helps net gross our some provide that So to color QX.

Thanks, we're Colin not innovating we people treating question with There's mechanisms for assure on obesity. can a done your I you of behalf for can obesity. future still do. on lot

think but your related new of incretins interested also and on of to come broadly from mechanisms. open non-incretins-based for eyes in types Lilly variety keep I more labs mechanisms, a

bar uncoupling about several You promise are also high put specifically think there to we caution treating one of obesity of others, I for but just mitochondrial asked a that sort develop, have have highly note and I a for very though types often lifetime medicines patients. first need highly remembering we for and medicines the of safe that that well this is disease foremost We a extremely population. really and need are chronic prevalent patients. tolerated

we're So for looking future that's in what mechanisms.

next Colin. Thanks, question? Lois,

from is question of JPMorgan. from next line Chris go Please ahead. Schott The the

donanemab very I it the of my think then of access. was still be out time. Thanks over could that just tied maybe you. maybe a CMS above Thank using And ramp on where decisions? means you set huge et physician a and have Is kind think much. that or XXXX a you education look for through net cetera. do questions. be bit approval kind between that to donanemab. to Mounjaro So to One price How had a last approval. into accelerated talked opportunity Great. about that full guess achieve wasn't elaborate closer approval Trulicity and there follow-up you accelerated could payer going I manage on I reasonable now what occurring full to as of we're infrastructure, really comparable approval question that know about revenue gap on that the we of But whenever a to

might the We'll ramp over Mike to kind about price for to right. Mike? and occur about education. of on And All then Trulicity. activity question how HCP would time Anne your it to go up donanemab Chris. Mounjaro Thanks, question compare that to

how I I'll when get for our thanks or broad - Yes, reach access roles the support Trulicity. differently we'll address that and think similar we obvious for maybe how have reach we reasons ultimately we when price you – way. Trulicity. look net mean can't Mounjaro on at into Mounjaro this promote to if There's question about have levels reach patients versus about but I we – nothing access question. the for for we'll

do So of it down we We at with payers. of than better We have profile. price innovation net to better come price should net day a a Trulicity. will believe our that in end that it the negotiations there. believe lot Mounjaro invest the has a And

Anne? Mike. Thanks,

for Thanks, on and Chris Yes. physician the question education readiness.

So is as going vast provide access for you to the accelerate patients. said, the approval of not majority

to medicines. us some bit easier So it the approval doing actually great that made in have deal way. little these for to a would obviously, that And the it can accelerate doesn't system impact maybe have a there's wanted of do but that do, still sure been things make we we that do to healthcare is ready

ecosystem important, things physicians that sure are can pathways on that refer Alzheimer's make making there's we that, to identify such as diagnostic better So sure the patients. infuse incredibly developing begin these disease properly integrated working

area right So focus that's now. of the

to PTAL that launch we're then tests expand as focus this diagnosis. area to sure that be we make key to of to a for And continue our blood intend to committed continued are for PET diagnostics network Certainly year. patient ready Lilly. well and We've

So think many that things medicines. making going can can for people access and these sure I on us that traditional make ready approval very

next questions. Thanks, Chris for question? the Lois,

Fernandez from ahead. from Please is Seamus next Guggenheim. The go question

Thanks Great. for the question.

is And to to then and if is developing where is wanted see hoping of that from could product bit positioned. see how the I pursuing little oral of sort there you oral you and think Lilly potential also GLP-X to is. need see this that Is your Thanks. I of about unmet you robust further terms likely of, agonists? think develop that Dan, combinations a talk outside the, developing the Mounjaro that be in A very the an where you well? market ask space bit is how something weight we little as you So loss other do add-on to just what

go this to Thanks, Seamus. on question. Dan We'll

add the a to on clearly some around questions. Thanks, US problem Seamus. Mike marketplace I'll get of started. the in is and wants But world. Maybe huge obesity the

one all million soon. the a obesity that world the XXX even potentially Americans of think I pretty reaching and around interested injectables. market That's with address probably billion with solely could not people companies

of going the around need world orals Ultimately the the our the and tolerability just have injectables. goal of safety that match So it's to scope orals. given can efficacy we're to problem

I course over But catch going goal. good get space prospects first to of well. initial and up will and oral then that the our this orals time our better has meeting attempt GLP-X noting think are is for as the in really that injectables

The was the in catch second obvious think other orals GLP-X part the of single right and mechanism, incretin now which how your I do oral agonists. are you're issue, space is single an of orals And sort to alluding up. our question

seen dual I like not It's good, what think, hopefully and I for think, competitive single as drugs GGG. triple agonist what agonism with we've achieve. can as with GLP-X products be or with agonism Trulicity great against achieved can even tirzepatide

to activity that bring additional working can you but patients today incretin on we're solutions hard. in a so pill. bet, disclose to ready can And oral we're Nothing working

next Dan. All Thanks, Lois, question. right. Okay.

Meacham from Next ahead. go of from line Geoff Bank of question is Please America. the

exposure mix potential of which has ones if from a utilization how the real for the related trying Mike on is that in inform primary on I the payer could Thanks at a moving how of the maintenance longer does with you. you And on studies study thinking for to today Mounjaro prescriber care two the Good on morning, Dan either have discussions. you up versus question. use I'm get do clinical compare duration Trulicity. think in all tirzepatide evolved as coming then know have obesity? sense guys. and SURMOUNT-X tirzepatide. or Thank maybe base endocrinology based And target, the but but I your world?

Great. Geoff. Thank you,

So we'll of tirzepatide go the from base Trulicity. Mounjaro then Dan and SURMOUNT-X and the question duration on to for on how to prescriber compares to the Mike question of

Yes. Sure.

there's come can't here. often don't people for disease. course, therapy think that doesn't I mean is A just medicine obesity in such need to the off a often of patients the they need working, they As disease because And take -- and saying I benefit diseases was of times or anymore of chronically life potentially either chronic a therapy clearly therapies, lifetime see. of lot happen for they is

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think will So have long duration a to factors of I therapy. pretty those combine

and We marketplace Mike? see the but there, early patients, in has have wait early on. Anything to from maybe Mike still pretty some signals

today stop helps like what reducing during that their it on But is know much that appetite they as people yet they consumed Mounjaro, -- do used taking reduce is and data as being when they is when what investigators lose back using realize our what what And patients stop It studies from qualitatively and we the that. who've to Mounjaro weight them once really hard does goes no heard and appetite, appetite. Yes, the about of level, before. start XX%. we it hear lose benefits what and our the that that was they we -- enjoy their it

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two do that get obesity reinforce chronic if eventually approved. we for and think of help diabetes, I type will tirzepatide for the use So

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say the doctors within So the Trulicity of who the universe overall is point. Mounjaro at I'd this write

question. Lois, next Thank you, the question. for Geoff

question Research. next from from Wolfe is The ahead. Tim Anderson Please go

comes the regulatory FDA there lecanemab, a if going here question FDA they would area to CRL this would levels. the your higher for risk that the so, drug results is Lilly contemplate on there assuming same guess If is suggest Thank around in X the highly I'm TRAILBLAZER-ALZ E versus bottom to agree doesn't see certainly efficacy study. rates wondering that. H to donanemab. your have conundrum concern potential second data I likely why is to reports from when line you. I benefit want issued with area that a The a be and lecanemab prior maybe full relative out. create

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the for to Dan for question. Tim, We'll go this. Thanks,

of Yeah. which Maybe issue the is I'll answer part first, the the the question second did FDA around, why CRL.

focused FDA the FDA were it exposure. It explicit the issues own here was suggest some that FDA's on in regulations was We ARIA actually pretty all the that in to think CRL. copying the what should like I list CRL. discuss investors XX-month didn't about the of words deficiencies

nothing to there. So further speculate

of think and ARIA-H this against is drugs complicated I a study aducanumab. on rates We your across question did ARIA-E one. comparing head-to-head

type learned grades stage compare I pathology, and because on like and exactly well the we've use the dependent genetimib to of of MRIs who of as underlying lecanemab highly different disease across of you baseline how rates studies as think that and ARIA, patients to read trials, their do ARIA enroll it's trials which the important of characteristics them. scans, brain are are that

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should though of ARIA. on rates symptomatic is be focused we What

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out for. we'll that's be So what looking

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of wait in in In we good other and that I to TRAILBLAZER-X, members level similar have very over for The the TRAILBLAZER-X concern class. very, very TRAILBLAZER-X. the that. see numbers our we'll think numbers look And of were what high. is not

you. Lois, Thank question. next

the question Morgan go Flynn from ahead. of Please line Stanley. The Terence next is from

had taking Hi. was you I guess I the FDA inspection use North Carolina other part for facility relates if yet. voucher was your Mounjaro Thanks review manufacturing. question. conversations two wondering if tell you. a for can for initial so and the new has if filing? wondering if payer the tirzepatide one you've And Thank to planning just us of to that question me. first then much any a Maybe obesity. for on yet, the priority you're completed I

Thanks, Terence.

to I'll on on think question I payer any over hand question and Mike for your on whether about to then Anat commentary manufacturing been the there's conversations obesity.

nature on we we in had expecting online. beyond this producing site comment when Obviously, specifics to for investments the talk and because goal. question of to RTP. are it's RTP year of will we but that's about about to start -- it's to think mention going RTP, incretins North large progressing is FDA capacity important I portfolio. that towards as on going side We that next come I this terms think node the Carolina, can't on proximal we're schedule of planned. the But the to site when interactions, substantial is this progressing making online your Terence, on come

our in when And we've the the in investments RTP doubling what we've expansion about site of North at and year year. sites largest the So, additional XXXX. probably site $X.X Ireland. announced ever India it's Indianapolis sites We're alone, in manufacturing look large had this we north or in very announced investment at second billion of Carolina, site of Concord, in we've a in – as looking had this we just capital site a

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build So kind helps portfolio. that of that across Lilly the capacity us

Thanks, second Anat. on Mike the question?

Yeah.

globally really the treatments adequate. has obesity a the been market been you the of look good on that obesity. really thing the you million I people the XXX really I obesity the market and is it's that in to XXX think to US, people but slow mean at access focus haven't And develop. see million because massive historically size

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to does it down on highly and payer So access, we're doing that. focused come

XX into it about access employers that talked call and that. stated Noble what's million they in recently opting have payer way, their Americans access the to obesity and

we're medications. with Access a to that. today We're is market haven't and point access. great all our starting But where yet, term started but for be that payers conversations to that's deep if focus access for at understand long So the would shortly. into improve will diabetes discussions

to D. who health We failure who unlock commercial access investing people live with Phase programs significantly people where demonstrate sleep with potential for and the or outcome obesity live also benefits, hope with in obesity tirzepatide, We're people, in live and obesity. who are should segments apnea, Part for III we and they investing large using heart

much power helping engaged with They obesity and representative highly who walls my career, And access and I've seen treatments. what congressional of important effective advocate the do medication. In with the year that, in consumer over are employers to seen live in have to last people improve the for access. will for access interest addition, willing is an we've

a people. establish So, will take than actions our while ever think to it market I I'm obesity of potential the are ultimate lot more encouraged and time unlock goal, help

still of but be a So work done. to I'm encouraged, obviously lot

Lois, next question. for the question. Terence Thank and thanks you, both,

question go Cowen. is from Steve next ahead. The from Please Scala

adjust just be question you on the I'm you. an year? late tax earlier different year. but this clarify situation doesn't on LPA, US much Anat. is is Dave, But guide earnings? you to the get in until clear, can I typically behind, were typically year particulars situation Lilly that Thank no rate catch you going doing it a is add how way assuming Thank impact correct. for And to something in If since could legislative it up? the why doesn't on this so, profound if adverse can A not you. year Lilly adverse and And just assuming

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Steve. Thanks

it assumed support into late is be year here look fact change broad So too provision, Last it. how read at Congress. we in had hasn't based and in on enacted very XXXX happened. tax for we much the in this year, that wouldn't this We but I this by assumed will

think thing the doing deferred, that zero. update in. I accordingly. likelihood we'll point, or is the we're So get obviously, If repealed the at reflecting of is this only of we're situation does it reality don't

still but need could does Congress to Congress to will it this this it add So going. -- take get happen year,

we're reflecting So the simply situation. current

Okay. I'll question. the start with LP a little

target data see and condition an a engineering. I'm is developed easiest this the the An one obviously, I first-in-class first the a a have super molecular clinic in really market oral widespread to against This this here. huge one very such is from two oral drug opportunity for program. comment only maybe feat so We LP the important. medication programs, think, is is a for little of oral the probably excited molecule to on

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add add to just comment. Steve on -- Maybe the little a LP

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question. next Lois,

question Cantor. Please Louise is The from go from ahead. Chen next

Hi. Thanks for taking my question.

of for So obesity risk I an to in reduction you. wanted think there's to amount have for see minimum ask is you, what you'd relative do to the here? outcome study Thank something that you be payers convinced

study in want Thanks outcome an reduction amount on the we'd Mike, do minimum relative in you obesity? expect chime Louise. risk of that for around to

think That's question. are all Yes. a access. it's that in looking a all, for don't point provide of payers outcome good I binary order to first where mean I

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and the in mean data we SURPASS I reduction today, meta-analysis profile blood surrogate what CV as our the the program. and as confident have we we program on pressure with confident in we're with see With outcomes and and lipids, fairly what SURPASS based saw our risk in that our we're well CV quite

won't but number, I we're payers we'll And with excited you think where the outcomes demonstrate be that I be at. give we're I exact about. to will So think able pleased

question. the Lois, for Louis Thanks next question.

David from Risinger ahead. from comes go And that Please Securities. SVB

he's or mute. Lois, next there? question. like Dave Okay. are we don't Dave you Looks have on

Please question Chris Goldman next Sachs. from Shibutani go is from ahead. The

Mounjaro I and question a on Thank can Trulicity. with you. interplay If the ask

observations Mounjaro, been forward higher share about this on that past you the patients to now. this of any seems see the through year? XX%. than how terms Can That little progressing in and in thoughts you about has commented less You've it bit on be a

to the guess from go Thanks for on question cannibalization Mike, Chris you I question. the, progress. that for will and we'll figure that how Trulicity

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you. Thank Okay.

Lois, question. next

Please Raffat go Evercore. from And that comes ahead. from Umer

a question. wonder guys. the primary focus for along interactions taking III Hi endpoint and/or agreement I I there's incremental a if FDA been And feel from CDR been about I upcoming how you the question agree ADAS analysis? for MMRM there donanemab endpoint primary scenario Phase Thank And with this now. any a Phase There's Thanks investor for the thinking heightened on The III. lot with a are on you. patient also on Phase III? be my where If were get to doesn't investors.

Dan on Umer. endpoints. Thanks for We'll question go to the

Yeah. I lot learn Thanks. from a here. Clearly can competitor there's readouts we think

our lecanemab And I actually eyes, ADAS. so an like validates in think it data further looking at endpoint

the an ADAS at Sum If CDR effect a look homogeneity on versus for there's in endpoint forest more you just like example of lot Boxes. bot

before feel say confident right endpoint is than I the that that ever go. we to would So way more like

you the On guys should and Boxes you CDR too. the well say, it -- hit other position people that lecanemab it's hand might achievable of take Sum I could then think the since do

as still primary good some takes on some a there. the and about outcome. there's So feeling pushes But ADAS whole

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and So see. let's wait

Lois, Umer. question. Thanks next

That Wells question go Fargo. ahead. is from Mohit Bansal Please from

Phase But I it I I'll differ Great. how name or it. my Thank mean you're a cannot for question subcu question. because here. you does your regarding a similar pronounce with learn Asking remternetug the much running donanemab? versus Alzheimer's next-generation very -- drug. III taking trial Maybe

So what trial? Phase the for of this on based would outcome the be read donanemab through III asset particular

do you want bit to remternetug? Dan, a about little talk

Yes.

new medicine, an donanemab has a it's is type I NXpG a think beta. epitope Remternetug antibody of right. ,you've same new of it against molecule, but got that is this form the basically, a which

action. formulation Maybe ADAs equivalent better little So a and and a better certainly potency no very things. mechanism drug properties including, of

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to hand, other the donanemab On exceeds as if I would through expect read expectations, well. that

Thank you, Mohit, Next question.

Seigerman Please Evan ahead. is question BMO. next The from go

you taking for much questions. Hi, guys. so Thank the

a really doesn't know we Mounjaro drugs. Alzheimer's, coverage much additional obesity look of in add some Medicare that patients help Medicare to coverage get population for talk that revenue about drugs While Thank like obesity potentially discussion Maybe what around, just Medicare from Can you. pay your approved. the on parameters could for opportunity including, you if efforts perspective.

for over for cover Mike, obesity? Evan you talk I'll do about the Thanks, the to want potential question. Mike. hand Medicare to to

I diabetes D. question. medications order Part it's less to late on good take action Yes, in to Sure. going covered mean, to Okay. Medicare allow be

XXX Reduce program. acronym little support Treat over that people for it's senators, growing and the behind The And and support Act. bipartisan congressmen, And large senators is a the is more there more across So Washington. TROA. for there's Obesity growing TROA, are a

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next Lois, Mike. Thanks, question.

question is Credit Suisse. go Huynh from from ahead. next Trung Please The

Academy Crédit from But a they released the Last medications. anti-obesity Trung consider obesity. said, Thanks treat guidelines, American they obviously, recommended childhood to treatment with squeezing Suisse. In guidelines core in. intervention for is those month of also they the I’m component. would lifestyle Huynh Pediatrics their me

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that too many have with live and people who and includes adolescents in obesity US unfortunately feeds. We the

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next question. Thanks Lois, Mike question. and for thanks Trung the

next The Barclays. from question from ahead. is go Carter Gould Please

At missed unique austerity in guess that measures We highlighted you December, as Anat. bit the a a a position. you Thank I potential in Europe was of question. risk. for taking one Great. for Back hadn't I that don't time this today think of some I heard but apologies We've since that front. heard all. kind if anything not similar I many on from And companies it that time. messaging heard from

made impact? you're countries any this? Thank of it's you. that we thinking know any specific you only products comments, in I think days those so XX sort or been So, or but advances of about And about sort should since how

I'm question. of to the President European measures. who's to Ilya hand Lilly going our this for comment Carter Yuffa, to over on the austerity International Thanks actually

a been crisis question. of in markets to Ukraine number in Yes, and that I partially Europe inflation some due measures, have and appreciate crisis the Europe. austerity have energy taken There

the broken exited we We system voluntary UK, so Germany, have we that. obviously, is think seen France, and

the XXXX. austerity into are overall We've -- prior contemplated that And And so we is declines some to price impact for there historical guidance our there. in in years. measures relative in modest

decline to that in Europe. in to in price continue expect We mid-single-digit that be

the Lois, question. Thanks Thanks next question. Carter Ilya. for

The from Baum next Citi. ahead. is go from Please question Andrew

question you. US commercial Thank for A access agonist. GLP-X on

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of given the around question how Andrew your on stickiness the IRA And wide-ranging Thanks, talk the I'll on first oral over for the in medications. second some diabetes might access to for Mike? older fit the GLP Mike then question diabetes. of hand to GLP-X. about potential question regarding impact of

Good Yes. questions.

of On Part patients will use and it, the go the outpace Medicare will who live IRA cost D benefit who side are GLPs with it diabetes down.

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see US So other in DPP-Xs of off of I impact markets. much path the going don't an or

we one And Mike. in I the queue. think question Lois, Thanks, have final

the to go let's question. last So

from you. Thank Securities. go that's Please ahead. And Robyn Truist Karnauskas from

in I UC, sorry. just But for given but you and are more wrong, question. thinking up move about launches have always competing the a then like the launch seems Like like start that And to they're see Do how Mirikizumab of Can you taking Crohn's there's very heavy much about prominent. launching? you you be what do I a for just little for how get What Atopic little uptake lebrikizumab dynamics. pretty my atopic bit to the use second Thanks But out. was can need crowded. same Great. out of here. data the this pulls with been coming is and talk I derm? reading bit getting question you Like that get Thanks. about some quicker dermatitis know pushes to in kind it promotion also DTC into as soon. you might because market? for for [indiscernible] maybe

then for Robyn in for the these go Johnson will market the Patrick questions. UC first mirikizumab both lebrikizumab. Thanks, and Patrick? competition I and to on of on

clinical mirikizumab. remission Thank histologic statistical see endpoints. have and you both If we XX endoscopic feel overall the Well, we have across XX% meaningful with data clinically we very more clinical, and the very much. and good we seen look weeks, we at improvements symptomatic, than on

colitis, is bionaive that patient same the we with the if results I important What populations across the saw and failure bio you the ulcerative at think patients. look

I positioned here. So the for well extremely launch think we're

More completely We demonstrated week urgency were also of a factor our either at on agency. but XX. patients or for XX% almost patients than or important it's extremely

responded a we first-in-class we ulcerative will second are here that line probably used that to placement haven't and first-line colitis. treatment mainly But in a of for believe initially have TNFs positioned believe therefore, those asset that we So for appropriately similar. we long-term, be

have compare in as versus we we what's the competitive believe landscape perspective, bad if so across a mirikizumab. we SXPs marketplace seen have the the JAK have with data compares to for But other well. yes, from companies as both don't so And that and pipeline exciting favorable we the currently It's in well data. what's far, inhibitors mirikizumab IL-XXs very as other outlook

launch to mirikizumab exciting year. this So of half the first

lebri, the When outcomes positioned dermatitis. upgrade actually, to patients it are of think with really uniquely comes to expected I atopic we

at far. Phase probably than with also improvements each, importantly, targeting and similar a to actually and pleased clinically the disturbing sleep saw cytokine and at quality so with we IL-XX which that probably extremely think when I most high the relevant dermatitis, we and high We across that potency comes atopic the sold of achieving we maintaining affinity, data, that Week but Week skin have that it data treating statistical across asset with QXW meaningful the a for more most factor seen have rate. both clearance And We're patients an and patients atopic QXW of the results it XX, life. very slow here And is formulation. is that does off binding explains both XX, and dermatitis, XX% III

will the mind It's we first-line believe lebrikizumab expect that submission become regulatory excitement not the the announced XXXX. important on to the and until health to leverage QX of care a well in likely most payers at tier actually to We community has pathway. and we that to from as of that biologic. potential traditional QX lot providers earnings call, But have launch we both Yes, market. a the get

Thank to up? you, Patrick. wrap Dave,

Great.

pipeline I strong questions call earnings across your another the core and the think the appreciate participation today's results patients productive serve. of the therapeutic in important of was year and we areas our that's the generated appreciate company. portfolio. and I last progress we our And financial interest your company, question. we for each in behalf delivered on XXXX in

We have us. aim to continue we meaningful of opportunities and the that execute our ahead momentum in on XXXX and pipeline launch

if follow you didn't for with IR, get thanks a and Have great dialing day. you to have in, that please we up So today. questions

call does dialing XXX-XXX-XXXX February our participation And may today. at you for and any for code will and made X:XX does Again access ladies Event using Conferencing. be this XXXX-XXX-XXXX with for dialers conclude and beginning code conference numbers your XXXXXXX. by those XXX-XXX-XXXX. replay for and our the Thank are that conclude through X the at running access And gentlemen, Thank for you. access entering conference you can XXXXXXX. today. this replay conference and AT&T the AT&T International today, system XXX-XXX-XXXX midnight, available And at time

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