LLY - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q4 2020 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] And as a reminder, your conference is being recorded. I would now like to turn the conference over to our host, Vice President of Investor Relations, Mr. Hern. Kevin sir. ahead, go Please

Kevin Hern

morning. Thank and Hern, for Lilly joining President, you QX XXXX for Company's Kevin Relations. us Earnings Investor Eli Good Call. Vice I'm

and and are Joining Mike today's Chief Mason, Durfy Biomedicines; Diabetes. Ilya Scientific Lauren President Lilly Officer; Dave Yuffa, CEO; White, Skovronsky, Josh We're Anne President by Lilly Ricks, Dr. me of Investor Dan Smiley, call Sara the also and Lilly's Relations of on Officer; President Financial Chief Lilly Smith Chairman of joined Oncology; of team.

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

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

on a X, exclude during transition via January exchange prepared we our though full will measures, as present on the earnings that and offer complete XXXX. the disposition XXXX, the financial remarks, to commentary our focus financial As contribution Elanco was non-GAAP which reminder from per share

results. over call the turn for summary our I'll Dave Now, a of to XXXX

Dave Ricks

XXXX our to top-tier and the are provided XXs growing framework our operating Thanks, mid-to deliver for call we noting revenue continuing how guidance increase we expectations to about XXXX margin Kevin. to thinking R&D a to while growth into in productivity. XXXX, December high continue the On period,

for two that we grow our few with each and past it significantly positive of these increasingly Lilly's for important begun management's into growth we in throughout pipeline XXXX. summer, industry Investors deliver outcomes In half expectations most Verzenio met tirzepatide coming evident our high to and We question, years. three assets there patient on breast second a support this have ability growth of are the to last months, in the term. with answers areas potential prospects for significantly donanemab, reinforced beyond we and to was unmet to medical midterm the in the believe data in Together next with investors good decade. for exciting need. meaningful while chance was upgraded cancer were the LOXO-XXX, improve them the long with provide our for that of insight and XXXX, As have focused data early

for future, challenging a delivered these I and our drive that While readouts complex incredible pleased way in am we the with momentum also XXXX.

midterm exceed revenue XXXX our enabled X,XXX. Our the to to X% of revenue goal CAGR XXXX from us years

the grew the an versus to headwinds pressure pricing strong Revenue percentage This despite or demand effects and continued quarter. XX% QX in Turning currency. XXXX from COVID-XX. constant of points impressive XX%

continue to products this revenue, our grew of representing for drive now growth XX% the revenue business. quarter. and X% bamlanivimab, volume Excluding Key over our base

continue modest We and drove operating growth expense in productivity strong of QX margin revenue significant advance as the to combination our expansion. growth agenda

goal a to delivered we in our We're business expansion our nearly of X,XXX margin operating and continued have proud basis XXXX. impacts COVID-XX the the approximately operating revenue an XX%. XXXX, of margin was XXX margin operating QX quarter roughly non-GAAP basis points versus of percent for and full on points midterm margin Our XX% excluding expansion year, therapies, have COVID-XX achieved would of as With with improvement since without XXXX. of

people LOXO-XXX, tirzepatide the baricitinib In milestones to multiple since use call. include noted the QX patients granting and collaboration fraction our donanemab; cancer of failure in submission These positive pipeline addition and heart empagliflozin Boehringer with achieved reduced in and earnings for for the we is help FDA injection done in bamlanivimab with of performance, breast to the in Verzenio the and authorizations results Ingelheim; strong the early the COVID-XX; submission with emergency in business for U.S. Japan. I U.S., This Europe

acquisition growth Therapeutics. QX, by to During and dementia, other the the the by as Lilly prospects a across work, portfolio operating creating clinical-stage of This anchored that pursue late-preclinical-stage acquisition Parkinson's, a growing augment put be increase we external well to therapy consecutive our of cash gene innovation promising therapies in and as for continuing X% adds third for disorders. announcing year, modality Prevail Prevail's Alzheimer's, will neurodegenerative to new flow gene a dividend future program with ALS

Moving Slides X to and X.

half of a list years models President earnings that in see a Chief our Lilly. events and She's of since of announced Shaw, who our values. Senior an Committee Vice and member been In call. of You'll after really year and our this service first we Executive key leader last XX invaluable Arti Digital Officer, retire November, the to will our Information

In call many information I And review she for Josh our Arti now, addition the patients to aim deep mentored to for throughout year Lilly. to over a strategy, organization we her and the to contributions leading developed turn the want QX the and results. to and to talent serve. care development of full has demonstrated I'll our digital thank

Josh Smiley

sales. percent our XXXX. increased as points XXX financial revenue in declined Dave, And and margin Slide basis compared Dave as non-GAAP revenue a morning. QX Gross bamlanivimab XX.X%. X to mentioned, to QX increased performance and of XXXX this summarizes quarter excluding and XX% Thanks, good X%,

revenue of in a was as line related of and QX impact gross bamlanivimab percent margin manufacturing revenue XX.X%, performance. the the costs, Excluding XXXX with

far year. expenses reduced were P&L. driven to relatively in operating over compared a increased total the growth, baseline the revenue as outpaced administrative QX expense QX Marketing, income R&D products. compared X% increased expenses, percent down X% by Moving and as last decreased offset investment X% operating therapies. XX% of due selling Operating expenses and measures Operating COVID-XX expenses for quarter. in to XXXX COVID-XX to and XX% investments revenue the resulting key growth XX% compared Net to XXXX. of growth flat, expenses productivity income R&D same down as activity quarter of COVID-XX was grew in

million investment on Excluding expense in the to base and quarter, public of for income quarter grew XX% income income QX. for the was margin Other of of equities. impact and COVID-XX $XXX our therapies, XX.X% gains QX driven by compared in operating operating income the XXXX $XXX million this was business

the XXXX, equity investments to in our losses exclude we QX due we non-GAAP our gains As or beginning earnings call, from measures. in will

move We that workbook XXXX apples-to-apples enable you to basis a to XXXX for investor have posted supplemental an performance. as QX we have comparison and compare into non-GAAP on to

tax last same the was XX.X%, per quarters. year, earnings XX%. items tax increase Our increased Net of therapies, rate bottom primarily increased net At basis XX%. while quarter net by discrete net in of an COVID-XX with increased line, share XXX per compared share driven the points both earnings income XX%, income and

to X. Moving Slide

XX% full same demand we In the of for line pandemic, bamlanivimab. or You at X% from the impact the measures spite non-GAAP grew excluding the can ongoing top see these year.

the growth by On on points we XX% and our effect to to Excluding pipeline. XXX volume COVID-XX contributing margin products revenue expanded rate X, EPS operating basis of quantify Slide and continuing our invest while therapies, price growth. newer behind

earlier, partially mentioned volume QX revenue constant worldwide XX%, in As grew strong during driven by price. growth currency XX% by of offset

XXXX quarter XX% Foreign of to revenue a U.S. and X% impact grew modest exchange the compared had on fourth growth. bamlanivimab. revenue

price Pricing was a For the to base U.S. extent, rebates modest the QX, diabetes, of was primarily and expectations which ESI. by impact the a full led in changes volume consistent offset business, utilization and Taltz access, mid-single-digit revenue X% the and quarter a largely by access Segment drag increased on U.S. for was XXXX was to also highly in win the net list price performance our rebated in U.S. lower for a of Humalog. driver as more growth utilization quarter driven with XX% mix partially segments discounts lesser XXXB for primarily for this to decline increases, major increased a of offset headwind was government rates segment by by growth in by driven Trulicity at by fourth excellent Taltz, was Verzenio. maintain for and X%, price estimates not of Trulicity, price Like the

during midterm the trends quarterly course the While present, impact XXXX. in the our to expect increasing variability price are given we of stable payer price U.S. variability in at see mix,

Cialis, XX% XXXX and driven a and growth likely Trulicity volume significant the in by well in programs, of growth constant across countercyclical Revenue for XXXX. Europe. a drove experiencing favorable government-mandated impact driven grew XX% the impact by Japan, Europe XX% volume Japan X% by expiries currency due of in March into in partially Tyvyt price. the by to modest revenue led was products, Cymbalta currency volume pleased XX% Tyvyt currency are driven and offset government-sponsored growth. headwind as with and constant decreases by that and Moving impacting and XXXX. growth the is driven price growth primarily volume Taltz. We're Cialis our to by to LOEs products Strattera pricing uptake effect in from patent in went and forward with post-patent Volume growth growth constant concessions revenue Alimta, grew as continued looking Forteo, strong continued decreased which expiry pricing XXXX. by In decreased in In key in China,

growth strong We're coming for our and Trulicity slide. Canada. January also NRDL full about excited three oncology the were in at the of The constant forward added bamlanivimab same are the of percentage China continued bottom to Olumiant for as of and to Revenue Trulicity volume pleased our points Tyvyt We year the well uptake we the as in XXXX. from revenue launch momentum driven world information increased currency and the business, the that Verzenio. is of growth rest by are from and of Olumiant looking sales as X% for to

action while move delivered on growth points bamlanivimab growth well into key the of The Trajenta this generated the and quarter, XXXX grew to class over of of from growth newer sunset the total, to our as best-in-class of of over in and with this readout products products. growth. X/X up both FrEF dermatology volume XX% year. XX nearly the alliance in and as CDK look the the amidst challenges Taltz base of a with pandemic, revenue, contributions of outgrowing ending drive Jardiance encouraging with continue impressive revenue royalties billion of growth while in share injectable brands percentage $X metastatic positive reduced nearly by a for SGLTX in And adding nearly the in Amidst driving post-LOE the growth XXXX, as the for in As over will XX outgrowing of doubling grew this $XXX as ongoing year Slide billion in to total cancer $X.X percentage by the growing percentage the we the to revenue. at in outgrowing regulatory injectable new-to-brand our in XXXX. billion key our six Lilly's breast XXXX impact contributing GLP-X for of long-term class sales GLP-X data billion to we while nearly the growth last these nearly This revenue crossed strong our foundation shown provides that exiting are finish highlights of points These roughly the early revenue key and XX% products in readouts XX% for overall $X.X growth. we encouraged points rheumatology million, the restructuring and XXXX U.S. also GLP-Xs. HFrEF growth products survival by U.S. revenue XX, in share total growth. was nearly grew with volume revenue in access in XXXX with market XX% the billion year cancer injectable entering prescriptions prescriptions XX Slide $X Ingelheim. XXXX. heels total forward for Verzenio In Boehring XXXX. class, medicines performance the share making our by outgrowing quarter, market key nearly products strong in XX%, reacceleration offset presented breast significantly Trulicity $X prescriptions on XX% our partially and in in class for for U.S.

a to combination growth Lilly's continue after-tax drive key an future we through our growth products strong expenditures in billion Our update capital and XXXX, we invested of growth XXXX. outlook allocation. in will Slide to provide $X on capital On In drive business over XX, development, R&D. investment

returned and via approximately to billion we dividends $X.X repurchases. share shareholders addition, In

the year, XX% demonstrating announced the increase As mentioned in our third for earlier, also Company. confidence for dividend a we the outlook consecutive

on flow cash sources, by recently focused are external internal completed the Therapeutics. both the utilizing Prevail highlighted of as We acquisition strong our through and

will acquisitions enhance and We where we or assessing prospects. future our in-licensing, remain growth can active shareholder bolt-on value in create

to Turning XXXX XX. on financial guidance our Slide

non-GAAP our affirming this GAAP of next or Precision guidance Merus guidance updated as GAAP of are of $X.XX. now updated will impact impact Biosciences, guidance Therapeutics reported recently be completed EPS quarterly the our be non-GAAP XXXX. The and change we've to XXXX $X.XX and expected will to agreements, the range We Lilly's the reflect of on Kasei to for transaction. and our for be guidance, R&D There earnings per share result our for call only impact XXXX, Asahi acquisition expense which will of in the a Prevail with to no

As this ensuring the guidance we our We limit several therapeutic doing to on world. virtual. in exposure pre-COVID pandemic committed as call, with interactions and physicians, the most major we move key we Year, other our the part into COVID-XX for noted continue U.S. around New are employees in baseline. still due surge demand below cases to HCP many markets experience and our suppressed present, classes our remain our of to we and patients to are and U.S. At as the

continue impact care broad to navigating the have half enable driving return to professionals support pandemic approach our the this we While near-term care new-to-brand systems and on health the to the as performance, we is believe a year. posture appropriate in health may ongoing normalcy second of a for vaccination

was primarily and Alimta. QX was patterns. a XXXX In XXXX, This inventory $XXX burn We impacts a addition, million anticipate our lower-than-typical inventory Taltz this diabetes which stocking. approximately XXXX QX historical by higher in off as our XXXX having year-end build well normal year-end driven will products than like as

we experienced As QX also call, $XXX stocking in significant million I noted on COVID-XX-related guidance our roughly of benefit XXXX.

and margin in of a readouts. divergent high-quality inventory will remain and in full inventory those patterns our increased year Despite expect we trends, these operating expansion revenue outlook given impact challenges, for growth quarter mid- have the year-over-year confident on and negative Given we XXXX. pipeline in confidence our have recent first XXXX outlook long-term our

to now I'll to Dan over So, the on our turn R&D. highlight progress call

Dr. Dan Skovronsky

Trailblazer start results and can from for advancing Josh. We Thanks, as had XXXX in this and an exciting gentimab this to Slide Phase and disease, we disease. hope has are for in devastating takeaways providing key progress suffering XX to we our patients positive X Alzheimer's read you for solutions our of than spent study. XX, dedicated finding Lilly science the the Al their see more families out trial. On proud exciting from years

Instrumental relatively effective endpoint, the Activities a placebo disease: scale its with the slowing study, for to Living, where by on the cognition; of small potent by the modification measured ADCS to becoming and plaque-clearing disease combining relative Alzheimer's a efficacy we tool, integrated We clinical first-ever in in as for patient the with Disease very measures decline and precision of composite on study study a Rating statistical ADAS-Cog two function. XX% Scale. IADL, a primary enrollment of hit well-accepted significance and results, encouraged are drug, ADAS Alzheimer's XX is strong Data overcame by

pre-specified function placebo cognition ganitumab consistent we're very to compared did assessing for not not endpoints the and by While on study the improvements observed multiple encouraged all powered for though secondary was endpoints, The methods the across every consistency endpoint. more is statistical secondary community. on progression was and the encouraging, reach points by very time across particularly model, statistical scientific which disease significance becoming accepted

of by to end rapid means a saw ganitumab-treated of for XX reduction and weeks amyloid on addition, negative below showed XX plaque plaque a we a amyloid average, ganitumab-treated is average the compared an patient negative patients the scan, at baseline scan clearance Since the that XX had In amyloid centiloid centiloids deep centiloids. of this study. XXX who,

for forward sum screening this and group an high Finally, for was the incidence endpoint. or the few the is larger the discussing and biomarker. including We which Imaging look ganitumab observations as the data in treated ALS numbers donanemab that consistent X% and TRAILBLAZER ADPD E. We'll XX% study We finalize we exciting was began ADAS to to forward results X we becomes blood-based findings hope safety In observed, TRAILBLAZER results E be to to and next increase to key call TRAILBLAZER later X XXXX at patient the X. plan the last using P-tau TRAILBLAZER and engaging have primary present, exciting Trailblazer plans time, moved enrollment of trial, with CDR regulators. year. And for and plaque-clearing with and from with the patients at look enrollment. twice antibodies. occurred the trial. while virtual Phase X, year the a.m. profile ARIA TRAILBLAZER designed TRAILBLAZER as patients incorporated is study our was pivotal patient similar, enrollment meeting patients enrolling design expected were last AS statistical Abnormalities of treatment XX-month tau include Group, XX XX, these X a the a X, reproduce differences, year participants of ganitumab to on will an hope regulators this of on March complete at XX. trial, boxes with second with Amyloid-Related the interest the many ARIA we first consistent endpoint nearly extend which in added TRAILBLAZER-ALZ ARIA step is to experiencing secondary symptomatic At for March investor sharing prior overall of to an We sharing full We data. a from a expedite while we

Slide XX. to Moving

we which the our for I our will treatment number COVID-XX. As for in-depth discussed since highlight authorization for briefly a COVID-XX been Tuesday's granted as antibodies a bamlanivimab use now. of developments call, on there've FDA emergency last earnings November, only call, In

bamlanivimab, X We under Since for which antisemab we've for data X request together, from shipped EUA X a EUA approximately remain also Phase BLAZE trial. bamlanivimab the review on for based and submitted million doses. the

X days, eight or XX% their where first hospitalization a the year. data together among We granted shared risk reduction trial just around past week, the death Phase to for reduction for for doses XXX,XXX quarter bamlanivimab and those available home committed nursing support which etesevimab million further with administration in March. with for antisemab joint of government be together, in to This in U.S. from already will X In showed purchase Amgen by bamlanivimab use the additional Should doses the for to X bamlanivimab, patients, we through EUA for Phase end administration. any doses X world. the up additional have this showed the mid-XXXX X residents; we've BLAZE eisemanab of trial supply EUA of COVID-XX from over collaboration of the together to up prevention request XXX,XXX be BLAZE with to X high-risk million XX% providing by doses data available expect able mid-XXXX, COVID-XX of with an for bamlanivimab the

to the milligrams the together, antibody data, placebo-controlled and Initial arms data X two which from the expanded to feedback instructions FDA can Lilly the pleased of These Vier the of these updates milligram high-risk conduct industry available we working has the as our PK/PD diligently these collaboration X to the BLAZE enable no Importantly, we treatment minutes. COVID-XX. including provide similar to to doses to potential from no decided times trial with and preparation X,XXX commitment bamlanivimab from received We're Phase in longer ongoing have, response the We administration results little and deaths flexibility, sets. antibodies and which in those XX considerably. X,XXX together. in of current COVID-XX-related strains pivotal demonstrated to shorten frontline having doctors lower world. yesterday, from our collaborate reduce there load patients. X with make that the AB neutralizing VER-XXXX GSK, future XXX trial authorization are studies infusion seen to After and will administration we're them across were as results, in doses, evaluate administered tiseramab antibodies update times milligrams and to can patients and treat can And BLAZE infusion viral bamlanivimab also impact reinforcing with around nurses to

patients. pipeline. news January antibodies XX opportunities While COVID-XX-neutralizing the with of empagliflozin X post-myocardial the The our from have in Prevail. gene the assets progress modalities pain Slide the as two the Olumiant exciting Phase into X submissions noted COVID-XX Verzenio, and initiation the molecule, including dominated infarction call our with our since molecules two rest X from treatment past of ANGPTLX to shows two Dave few weeks, robustly from in new assets, submission the last of we the new movement of for Positive has of Dicerna in introduction eight donanemab Lilly's siRNA clinical XX. for and and earnings a of continued collaboration the select advance and pipeline Japan, assets Jardiance our Phase the therapy first Lilly: movement trial includes for Phase of for

starts the speaks year, It in during a XXXX's In of XX ended decade. organization determination doses, we the significant this of challenges R&D the total in first faced of studies, a Considering clinical the new with our remarkable challenging starts times. number X a including XX is new XXXX, and temporarily resilience for to clinical initiation for fact, the was stopping achievement. of total we which Lilly human Phase new highest surpassing XXXX of

for in early how expected our Slide reduced emphasizes we XXXX. mid-December, XX. Moving cancer cell heart selpercatinib for submissions in for cancer show XXXX blue to the a sheer that Verzenio tally the we United had ejection occur. to of key versus breast in final advancements call of States. events United lung guidance fraction non-small We we finish The for Since for Jardiance and checkmarks pipeline the of Japan, States sea in failure in the quantity

the delivered year type of COVID-XX for emergency from away take for tumors; with practice-changing my early diabetes, data is cancer, delighted potentially X that However, past the hematologic here, quality the for represented I'm breast including for RET as first-in-class of use launch a in authorizations medicines achievements two well help We're the inhibitor; XXXX. as the to address significant pandemic. the proud

As the I'd we very to other to in is like that Jake at Bernardin Nisha CEO for this note leadership that forward Loxo We model Loxo for maintaining highly as Nanda Lilly allows a continuity the role. responsibilities leaving with to continue him and his operating assuming contributions position Lilly. of his time Lilly. Loxo is to a transition with pleased to and Oncology at announce David to him look working XXXX, his of and Loxo. move grateful Jacob I'm and Josh in to will ensuring into Heyman, work very his interests CEO Oncology We're strategy and leader, grow benefit role, human be at continuing alongside to explore the consulting health, endeavors. Josh both in Bilenker to Lilly for and talented

XX. Slide to Moving

Phase several SURPASS to antibody X a data our read trial expected TRAILBLAZER discovering TRAILBLAZER the TRAILBLAZER year, empagliflozin of we the this potential results disclosed Based trial of looking the in building the just events expected tirzepatide just developing X data to out; the data that readouts Alzheimer's, program, on zagotenemab, have these ganitumab, design XXXX, for just the similar Phase focused year. anti-tau X to and read forward in high-quality several And and remainder readout other patients. previously help by on for the including readouts see readouts can immunology; are You for for out; out; trial disclosure we of the trial I optimistic mentioned. could we're HFrEF. read tirzepatide that to and including A early more patients. in Phase on where entered late several upcoming X are we new the that the on medicines assets donanemab major the recent The and number for pipeline LOXO-XXX, last XXXX impact to

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

Dave Ricks

Dan. thanks, Well,

remarkable its progress and Before to the let fulfill in me ways. as purpose briefly Lilly a XXXX Q&A, worked we year in to new we important made XXXX. was go sum up

to contributions more than fight revenue grew strong volume for in time. products business XXXX from XXXX. now account driven many products of by growth addition global since the In the the in launched against key XX% our our These pandemic, growth our for half first

based We category-changing continued and significant We XXX with innovation on our margin operating delivering progress nearly strategy, breast data. business. our productivity basis for LOXO-XXX, potential points our journey, expansion of delivering base early made tirzepatide readouts, Verzenio cancer

With bamlanivimab of Dermira we success combat external which an EUAs exceptional months innovation. and bolt-on to line past Lilly's will top ongoing the donanemab a share was example book ending Prevail December, to the Alzheimer's. increase, and have of Olumiant strength and XX in dividend We for our reflecting COVID-XX first in we January's meaningful significant and and acquisitions have been While leveraging $X.X and year, dividend in the via repurchase, of shareholders in returned confidence another business. billion the announced internal nearly success

that still this of was is a of headwind accomplished raging. the All pandemic against

to While for from the the does over not been Q&A. our near-term stronger. outlook and long-term that I'll turn call challenge, Kevin This concludes prepared the the remarks Year New free has never us

Kevin Hern

take Thanks, like We'd to as many from Dave. possible. as colors questions

the ask for Q&A first the instructions we're that session we you please So then limit the caller. your Tony, questions for two follow-up. and ready for to provide

Operator

the with go ahead. from comes question first Our Instructions] Bank [Operator of Please of Meacham America. line Geoff

Geoff Meacham

expand some to mentioned your just third experience? a have the know you beyond normalization franchise's And database you're what Josh, of a affected expanding those start Just donanemab, treatment you. discussions, that you from study TRAILBLAZER-ALZ the is you're still but X, of in safety commercial mostly to it say the having regulatory XXXX? Dan, COVID, impact reasonable assumptions just review XXXX? then, were on maybe on Thank in would I in planning couple. seeing are And for

Dr. Dan Skovronsky

Thanks, Geoff.

Your donanemab consider third at safety question to improve is starting haven't No, database. that we considered whether we'd the study a present.

Of next we course, discuss as we have with said, step regulators. dataset to our the is

that that if to that to this TRAILBLAZER-X explore could place need think current but see and through more a population. we now, determine those other study. there respect possibilities is studies, I populations patience, opportunities we do additional the for we're With I to don't working be think right that we necessary

Josh Smiley

Geoff. Thanks,

we our consistent therapeutic in get key although look at diabetes, grand when new this the looking across not immunology, prescriptions think point that numbers to stronger quite we like areas, as still areas, January, I and to diabetes back pain we're in see relatively it's here demand. I we're think in nothing markets figured think, have, saw U.S. back I suppressed out and seeing like what the most seeing has how we Physicians and patients to still but into May, some in April safely, we're are

like the to new of migraine. as quarter So, that I just includes we against them complex into degree in patients get and that treatments have areas be realize some variability cautious more we the starting first think have higher and

the maintenance think has pandemic. I good been throughout

I baselines bit of we in a half that but first of of in this quarter, the as see fair terms be, pre-COVID do levels, therapeutic still first little new get through below we'll we it, we'll to So, it's areas assume prescription normal starts. returned many fully expect the in year, the think to

Dave Ricks

in patients see as that Durham, not the you also, because anything just I think one some as affecting suppression Probably well share new the but our in category. volume overall starts, referring Geoff

Operator

comes Anderson question from Our Tim with Wolfe Research. next

Tim Anderson

file seems Investors you you the what given continue donanemab. for it what oligomers your And patients toxic monoclonal the in wondering this on knock industry need then, the after achieve latest giving down that subgroups, and you the are size have by described view chronically Dan, seen that? thoughts sometimes of what well on which normalization? the plaque if is share your based first as already X might to Phase trial could to is trial. highly approval me, of To unlikely naturally just odds the on can Couple different wondering, are but

Kevin Hern

Tim, those. go Dan Hi, to both we'll for of

Dr. Dan Skovronsky

in with on of our said forth your approval are study course, regulators. other In possibility disclose case, a FDA Look, discussions regulators. general, in that next So we, is and this question disease. we or don't single from we steps with Alzheimer's back of first the

been that well this Still, well we yet. understand regulatory disease. traditionally case, in threshold adequate trial. trial and clearly hasn't one we Alzheimer's has a controlled single, In trial controlled So the happened that means than adequate more have and

it's said, the not this I area. in As been standard

clinical single Of by can biomarkers. that's an approved characteristics trial, accelerated notably group a oncology, as usually, well areas, other course, a Usually, defined disease as Usually, pathologic that's in drugs response outcomes. in approval. well pathologic dramatic from it's be there's and

course, case different is Alzheimer's disease. that's quite in again, true dynamic than but the also oncology Of this of trial,

are exquisitely therefore And for was specific amyloid -- that the a Your It's designed thereby to species second monomers question on question efficacy it here don't oligomers plaques, be a of it's species is toxic the plaques. what plaques binds was rather think long oligomers. unclear oligomers. that toxic of we the to antibody the seems see than we is beta, been efficacy This toxic like imply the the is and oligomers. the it

in by we plaques, these as each oligomers two remove well. rule out other and However, that equilibrium with things can't do clearing are perhaps you

Operator

of from ahead. Please with question Raffat line Umer the Next go Evercore. comes

Umer Raffat

I or did Dan, ADAS I'm the how composite whether does use correlate and correlate in function three I very closely heading this but it be recent CDR some boxes ADAS with it fact more interesting the about that that well the composite where CDR about solanezumab new is your most boxes, prior they should wondering a did didn't of concordance expedition from some the studies, have boxes. CDR the in I'm donanemab. versus of with between closely for thinking thinking we that high versus CDR what is endpoint very find trials It the donanemab trials the correlate into guess recent of in ADAS? more trial.

a this bit different on have been little date. not up us year. if because MAb similar but X tau out coming this of or saw good color. And to you one it'd quite as how's you antibody ones the has had was target your progress other this than pushed fall the helpful any could I to this is, other some The very I well, have Maybe be Phase tau remind

Dr. Dan Skovronsky

the an first ADAS One Umer, Thanks on it. for CDR. trial, any two a Dan. with It's question statistical Look, when your Umer. for validation endpoint. good things endpoint really and behind is its there's correlation endpoint, that about we think make an clinical

of that time different other across together across So different patients in it is across we trials, put lot a data that. words, support different reliable points,

Second, patients. true. important that's activities be course, has meaningful inherently daily of of things that believe case, And used, it of composite activities obviously we and meaningful this patients. thought two widely Cogs are for living of This meaningful isn't in in both is to for that daily living, a inherently

that validation ADAS data If assumption CDR primary study? be Now, pick I'm measuring to all the the into boxes be on it's we statistical then telling That sensitive for of obvious, therefore ADAS decline for outcome more would we would why some you And ADAS sensitive and more should versus that based couldn't perfectly of powerful. the yet, better, going do a because be trial measuring couldn't our that did. of well That's ADAS this drug be. and be correlated effect. that it was be were more

have be very changed outcome trials. ADAS we saw but Alzheimer's thinking important and valid is on will we think some this a Based different trial, won't outcomes for correlation, course, of outcomes, still think haven't in I perfectly So correlated. we what and they our on

course, that's in with had to scientific Of discussion community. a regulators the be

our antibody. is this anti-tau zagotenemab, the With

of a beta is of kind Just plaque, specificity highly different based on as tau. donanemab anti-tau was aggregated a different anti-amyloid type its for zagotenemab for antibody. specific It's

important any not Now, gets the because lot that's there's of brain. soluble antibodies, we tau it in monomeric tau case a the tau, of other antibody, much in of like think and particularly

a left aggregated a after sop have up more not of have and lot is important of we tau. could species, to what all monomer think you antibody the your if go So little bit of and antibody, it

and So, we'll to see. have wait

a is and to therapies, learned younger a we're field to but taken is getting that anti-amyloid, lot things this forward we later from than that year. of this quite anti-tau, course, applied anti-amyloid looking data Of we've them

Operator

Our next Scala Cowen. question line with from Steve of the Please comes go ahead.

Steve Scala

Two including data leave the Based oncology, what any questions. Investor want A-beta have? comfortable driver LOXO-XXX favorable. in expectations sister donanemab full though are you've on antibody you Lilly looks knows Secondly, donanemab also other are and potential. safety Lilly landscape for terms XXX, for fully company. out be could like a than sales for TRAILBLAZER will largely and for multibillion-dollar us expectations. these failed conclusion X quite that of sounds it perhaps to with said, it in high better XX, best-in-class XX in the the also with? Has the Is potentially rolled non-oncology indications be that that you the BTK you MS, as looks or

Kevin Hern

the Steve. to one. second for the first for then Dan go We'll Dave Thanks, question and

Dave Ricks

or don't forecast, comment mean, and models on I analyst never would. we Steve, Yes. we

investment cetera. path asked. based we'll unmet sales answer we're a that But like forecast get spent later, question is forward, but path out, say in answer, question. up. there's we of medical today, FDA justified possible and what coming and believe failing, lot you the Alzheimer's to et to not way of it's own is any to to market. the make to a the ADPD about in donanemab and conclusions. your huge a talk directly So a is, for say as then guess to that years we've saying that. to of answer the We're you need, able size XX-plus a on invested And not data not has because and formal survey I field your can't we The money, the need point mostly can presentation I just looking the We're market, will forward one I

Kevin Hern

Thanks, Dave. Dan?

Dr. Dan Skovronsky

Okay.

great The inhibitor in why second oncology. it's question, LOXO-XXX a straightforward. generating such drug remarkable specific is That's reversal data really with uniquely BTK properties. more

not question also case, pursue to molecule. we would asking is, about, differentiated molecule immunology? the thought a being I that could this this same translate a we think in a You're lot which in highly

I an be certainly indications. as think this down for oncology is This oncology. generating we something the sister be immunology are a molecule. far road of the we'd will interested said, in question you whether raised you in That's But molecule, considering. enough

Kevin Hern

questions. thanks for Steve, your Dan. Thanks,

please. caller Next

Operator

Our Risinger next line comes from Stanley. Morgan question David the of ahead. with go Please

David Risinger

questions, two have I update. please. the on Congrats

would for to single FDA of the with file X TRAILBLAZER Lilly do from expect small which have donanemab? Lilly clarity And the second, trial sum boxes? endpoint consider is Phase changing X, CDR can on then you primary when whether First, the on currently

Kevin Hern

Dan? Thanks, Dave.

Dr. Dan Skovronsky

Dave. Thanks, Okay.

potential addressed Your first the which I think for question is filing, on we before.

discussions the haven't We those regulators. had with

schedule Of course, the we discussions around data world. move quickly the regulators to with and understand

say. is standard two As there. be I said what we'll before, and regulatory the well-controlled so interested regulators trials trials, to adequate hear But certainly,

Kevin Hern

the the is, over you And the one endpoint? second primary change see can

Dr. Dan Skovronsky

yes. yes, Oh,

Sorry, Dave.

it. is second the there of endpoint. change would can So we the consider course, we Yes, question

at inform us as the that conversations to anything far, that will well haven't X, that to seen decision regulators. get look our it. so we But with think TRAILBLAZER of I decisions, change totality data as and that we leads from we make

Kevin Hern

thanks questions. for Thanks, your Dave. Dave,

please. caller Next

Operator

go from Goldman ahead. Please comes Terence question Sachs. Next with Flynn

Daniel Ziment

Dan is Terence. This on for

you X/X discuss us. Just a Phase the LOXO-XXX on you data? to you. that for one if Thank from there's believe could On path filing approval

Kevin Hern

Yes.

to we'll White for So, one. go Anne that

Anne White

data, question. very excited CLL Well, thanks, the the obviously Terence, for we're in CL. And and about both

have do heme challenging. place, we be FDA accelerated malignancies so potential can regarding with ongoing in for the accelerated the And this approval. single-arm the discussions for Obviously, approvals

going discussions further that require to regulators. with was so -- really require And

that And we'll but or yet about the as which So timing we can't assured indications, be Dan we excited continue commit mentioned. conversations. more on couldn't be those submissions, data,

in saw broader I remarkable. we the then think on as CXX mutations, and this and the as molecule really molecule performance started focus populations a the data

we'll conversations posted. keep going, with you So, that keep we'll and

Kevin Hern

question. Dan, our next thanks Anne. Thanks,

please. caller Next

Operator

Chris next of Morgan. ahead. Our Please from line comes the JP Schott question go with

Chris Schott

Great.

some TRAILBLAZER is XXXB about of XXXB just reimbursement one in year. have from remind of been business challenges drug expect And with us your program the a make did one that What And on patients from rationale could the or donanemab patients? just go other percent Maybe us these on on a of then maybe scope of one. as last portfolio. second X changes in to the work you And your your of push XXXX? population? be also to based Just backs should just how we guess of just and thinking saw question give come group? there TRAILBLAZER, Then in through was either my that? high-tau should kind are I any strong just what we some the sense that there we thoughts what implementation

Kevin Hern

to Dan Josh Chris. and XXXB. go question for the then first We'll on Thanks,

Dr. Dan Skovronsky

therapy. at Chris, TRAILBLAZER A have the the is too spread you, notable about point it. believe Thank question past or that people return tau their tau are had Got much the population. least trial for in who high-tau feature patients for of brain. no the we who it's throughout of that the highest excluded their an amyloid-directed We brain

predicting even we either and set that, as this lead could excited see high-tau the to as to course, us in be presentation, X respect less therapy, baseline tau this including analyze data study. for current we're time Of response to what or excited more about we data, that in fully with hopefully, we'll understand levels in patients seeing upcoming TRAILBLAZER

very still much is that something is that so open. And

As we there. it, changing could we understand see dataand the design about think that

impacted of depends percent the that how it of you sort on of it. cut terms patients here, In are

the with If you and early patients of AD that's about start negative. before. Japan in Alzheimer's the double combined. of X.X Europe shown all and mild in -- that U.S. with patients, plus that those MCI, million We've amyloid Many plus

amyloid larger for that those but slightly one-third all. about tau a include We of didn't that. out group. take you in will tau positive at small fraction then be fraction patients. will no A them be And So high

XX% X. mild population MCI to AD those of once XX% you've So these said sort to of that criteria would all enrollment meet excluded TRAILBLAZER it's that in we've patients,

Kevin Hern

Thanks, Dan. Josh?

Josh Smiley

what been XX% size business, among on XX industry rivals it now. business well, the XXXB certainly the across look Medicaid segment the has our XXXB, years, fastest-growing, but for of if you Chris, about U.S. so of the as over we said the is the last business our and in

and go hospitals grown made the provide legislated have that at to to discounts when half we the these Of was of it's contract And care to to look and intent businesses the we to exclude that probably in actual overtime the that course, provide contracted about pharmacy the change business, back pharmacy.

provide made So to the change, we've that's pricing where there. not the

we of we're patient knew where there think they're I seeing together, challenges, those we apply long have that they're to be as and process challenges yet. passing impacts, but where would a that participate. Now, on implemented do that all at still for When we that's contracted those knew they can we as pharmacy eligible look come, insolence, We pricing said in we can we've demonstrate the seen in and terms that September. haven't entire much

change, per point. seeing the as we provided fact patient that this it's our the are at discounts we're impacting care being don't but think So,

guidance XXXX, portion the the XXXX. this that is a for with two consistent point price is growth quarter and provide is three tailwind We in in moderate made. which saw So would to expect we decision We concerns. be We decision customer think it fourth we've to we the far I everything legal be what there there'd seeing some with but would challenges, to a we're be the knew consistent difficult knew given implement. us knew in of program XXXb for we so would

this So that I on think at track point. for we're

Kevin Hern

Thanks, for questions. Josh. thanks your Chris,

please. caller Next

Operator

the line The Seamus Guggenheim. from of Fernandez with next go ahead. Please comes question

Seamus Fernandez

which to monitoring to with confidence a is donanemab give consistent wanted that the bit of second So update both in follow us study, placebo bit amyloid? on is, this arm had obviously expectations. blinding question, Verzenio get the up to the of of almost on tracking Verzenio behavior little I an relative color was absolute magnitude And then your how and that And the of your the patients their on just of one a just given clearing you plaques? question, can Dan, and benefits amyloid the tau the just of fact wanted

terms of But positive. capturing seems see it directionally, I starting in we're market share. think to degree and to starts, some guess, I fits incremental

in of to really uptake share? approval sales the could a Is disease? share how then, Just opportunity where market the changes impact so already get metastatic are going seeing go driver? an your Lilly ultimately in trying of And big or meaningful the sense Or you market thinks Thanks much. that forward? adjuvant can metastatic

Kevin Hern

second. Seamus. first the Thanks, We'll and Dan for to the Anne question go for

Dr. Dan Skovronsky

study focused very those pivotal that for Yes. typically this you, thoughtful studies, of TRAILBLAZER out questions the we X, we with Thank blinded, fully study. that study. Seamus, quality carried double-blinded blinding the We before use on said that regulatory for

amyloid clearance. in result there brain unintentional the And some know raised be Patients that the scan their seen that that's the You themselves. could unblinding don't see amyloid have the investigators that don't possibility PET clearance wouldn't of possible. as feel results a We directly. of or of

blinding side ARIA because X% symptomatic patients E or The other the ARIA over potential effect. is something in commented on cause any for had sometimes so. And Alzheimer's in of E can study that we is that a that

great without and that's And have with Alzheimer's I disease and at every think an that's drug effect the think, certainly in that something look saw we we first important complete I is in in to to question. that That's ARIA patients. certainly, study hope look to analysis, I wanted March. about the this share you then behavior of to at. data able arm. the finally, a be Really, And asked thing the was placebo when

did worse the on promising. level Sometimes, encouragement than and And your small here, typical. of It's studies we based data. you a placebo we've communicated confidence have -- that high because said look arm

placebo That's arm very placebo that arm aberrantly. in the not So but here. that is we'll of what's not performance the March, into with excludes behaving that very, get details possibility. effect. of Again, pleased This the driving the

Kevin Hern

Thanks, Anne? Dan.

Anne White

the question on Yes. Thanks Verzenio. for

So really And I as positive of another result, very another year Verzenio. very improve. of for was think, clinically as meaningful XXXX data and then was year clinically positive a and to XXXX you shares, noted, really our continue

drew CDK market no in is attention the think setting, obviously, this that do to class. the EVC readout is While yet particularly approved we

current are trends really and NBC and OS execution the logistically -- key our focus strong data, have. of significant particularly result which in we're then our said, competitor space confident the that a a that the on didn't So

saw increase is it and from a XX%. Verzenio a And agent. revenue to We pretty as now they're QX QX hearing remarkable we're growth that X% U.S. repeatedly that and was growth, 'XX, we period you for As really is seeing compare worldwide of more TRx 'XX growth thought differentiated more XX% of Verzenio. of of said, leaders what

then So obviously, dosing, activity the indication, obviously, higher we've -- shared endocrine-resistant MONARCH MEMS, others, the with data that we in primary a feel X population. saw that differentiated have we CDKX in we than monotherapy versus continuous and

think we're I of is the growth market. in So playing that that the really into seeing MVC all

market so, our that growth see expect our And we'll -- in share to continue to grow space.

in last others as Dave the adjuvant did and FDA at we side, to areas the end other On mentioned, the year. of submit

XX% it's probably metastatic an additional fact forward entry action market This year. population. XX% significant this in later high-risk is this you that look match we So regulatory to increase in the to if adjuvant current market size our criteria, our

setting. So that's very the is significant significant. than And metastatic longer be likely what's a will also treatment of will duration

number average patients patients on seeing XX will the right the on think patients continue are many are in now, of we're months for So study. And months. get to the longer. study study, treated stay on that for in still so I And

treatment as But question. looking we're that as forward it incredibly of the excited to bringing possible. Thanks as patients So the offers duration data. well. upside soon We're to about for

Kevin Hern

question. thanks Seamus, Anne. for your Thanks,

Next please. caller

Operator

ahead. Next, Please we Citi. go go to the line of Andrew Baum with

Andrew Baum

A couple of questions.

donanemab. on First,

talk is you there will define drug could potentially And where of demand, the an potentially Could may but sooner on be you patients? X your by to market that trying the blood just to On you manufacturing, perhaps observation any whether which test back given many submitted than because open that's reflecting the to be than the particularly be already, medical the the a And XXX? talk suggest your which also inhibitor you second and issue rather the of able I'm BTK on believe. then intolerant that market practice Anne, used efficacy liaisons hematology the understand your about of scenario you the From the donanemab at tolerability personal tau of have. particularly the the that you're know strong level even of first you preparedness, to CLL, could drug understanding of P data BTK set Phase anticipated to that without trial, a nature in do in for could I refractory second file would being could view. optimistic Thank that the community given or hiring this half. you're believe in you. for very to take high significant randomized setting? share

Kevin Hern

Thanks, first second. the Dan question go Andrew. for Anne and the We'll to for

Dr. Dan Skovronsky

Andrew, you raised an before on ganitumab. the We needs had all for manufacturing prepare be we excellent that question this to data. done preparedness initiated actually work to

is prepare success. at we do this always something We So, Lilly. for

the that antibodies, we them our so we're colleagues prepare the to asked manufacturing And ramping also up time, donanemab. anti-COVID at same for

or is we started we're both and phospho-TAL market. blood that to data what's with So work. more there. on, manufacturing the along started coming in and like making diagnostic to this bring ecosystem market again, before underway, going any of ramping that imaging had both successful well to course, The drug comes whether also test That's opportunities we're then, and underway, progress anti-amyloid needs in other I is to patients. We the up useful whether proceeding

preparations are taking. those So, we're that certainly

Kevin Hern

Anne? Dan. Thanks,

Anne White

for XXX. Thanks question on Yes. the

So of work with remember, -- talks on arm our in it's this about population, the our MSL portfolio. company going that's the across our important to

So be in the heading have XXX, may this portfolio but in to other assets that this is related we not just space.

large X programs. to identify normal of get Phase to are that field the obviously, portfolio. well. do as there into about starting helps make out trials that, you number But its a rates many they So have operations I XXX, excitement know, we we're high-quality importantly, force And much that sure in in that too questions include physicians. those the read us And covering treating as wouldn't that's

think an and story CLL, have has we is far what here. incredibly certainly we're in do is what setting. the in we drugs obviously, the contender exciting, have past, that even area the on as effect interested is As Particularly target tend that that seen been pronounced relapsed real there a sometimes have first-line seeing meaningful patients same that of in who in a pathway the effect in have oncology, treatment to more

the the that's upside here so And is first-line that for potential is LOXO-XXX that setting.

CLL. of obviously, initiate, that and are with two are patients, in And in this we're at you have the as and clinical And first a that them four riskier BTK-preta line, doing setting, but the head-to-head later-line So is potential global the actually of three still ibrutinib We this in we them belief do. confident know, in this in obviously, in really very but a a planning the in trials. a CLL. one studies, to looking lot year, to head-to-head is setting hence, feel but do of has molecule study

really ongoing So the space, FDA. reach. you obviously, this reach regardless, that randomized as wish trials that I with Those said patients earlier, clinical I in know are can't we comment to on conversations the to But need regulatory likelihood. the we

is trials And that's to intention so -- do those regardless. the

Kevin Hern

your thanks Anne. Andrew, questions. Thanks, for

Next caller please.

Operator

Our of go line Gilbert with next Please the Securities. ahead. Gregg Truist question comes from

Gregg Gilbert

there a On by the prior Dave, your the proactively and power limit the I like ready. plans along? set. of slower it I then to for the you're was upper some to on COVID And call, between think quite Josh, fresh. And the and this from is help uptake, sounded before data extent latest trained I even get on to hospitals that is latest maybe other that that antibodies, in was comments could disconnect speed the standpoint hospitals as in But anything realize up. picks billion $X from if relates the for well-known Thanks. than What's about Lilly this the of data is the being guidance necessarily intrigued worried the that your there move practical not to be data demand limitation XXXX it of call stone to do manufacturing antibodies? set

Kevin Hern

then and Dave to go we'll And Josh. Greg. Thanks,

Dave Ricks

since via antibodies. physicians across enable EUA. uptake rates, in. don't done the relationship medicine advanced be actually Yes, care the ways, systems you and I was what and to the health Okay. some guess working using of normal I been under the happens a an you we've that to comment. an in it it's, have And jump government This adoption I channels mean differences country beginning, preparation with commercial this. seems rollout. you between and of I'll inverse Dan, see -- we've test in about big the places highlighted when think and who's

One of on those clearly conviction is the barriers data.

-- week, I'm pleased in And with different And has there's conviction. confidence. data announced we effect last here, settings increase build to the a also I will too. think data I antibodies demonstrating adds will, So, that fact in is this promise and really think the are other to, class that it and the

at many will hopefully, There's health that well completely systems out endorsements been practical one with by there's not the have as COVID-XX will the Infectious out of with tons So two infusing worked change. scale, people by numerous many, NIH, is Disease other we worked said, others. and that problems hope is change: Society. That

material. positive health is quite at-risk health, staff So high-throughput antibody bit a you best actually administration. they're in departments practices. and of scheduling chart of lot almost for facilities to COVID-XX patients, utilization. cetera, happening, upon those appointments, using for practice a dedicated work can a And reduction with flagging we Where The et state of see that's share care

that that experiment It to an XX% New about that as forward. running to like as to about actually use But from actually in prove in we're moved see of UnitedHealthcare. grow. I'm going double optimistic see So hope more Mexico rate progress now. we'll December well it We the with

Kevin Hern

Josh? Steve. Thanks,

Josh Smiley

Yes. Thanks, Greg.

in for said billion. COVID $X a there's billion So is course, is year $X guidance to And range that. antibodies what we've lot of for this uncertainty of

morning the have. on with we've That's call, it's what we already that the that the the agreement government, quarter. agreements purchase first we've $X in just high billion probably Although announced U.S. this the with for signed next probability

manufacturing, I combo. probably and we've doses to million half think in then first based to in the the get in what past XXX,XXX year committed available monotherapy another of have terms of one about we already that, -- banliminivab on

and into on government year otherwise. U.S. much towards half out, barrier think, lot weighted per if the billion. we the So we of $X of of EUA yet, half heavily of going all get an can there's U.S. can and think countries, we available But we any the and government the high-income the a don't have I other don't continue it's as piece be these in of in second you course to and second sold still vaccine production or play for is above the combo that we to year, where the products of terms the could pace or think If I utilized. manufacturing if be the doses get a quarter. the of of stay million-plus at vaccines I with

could we to billion for approvals. as provide clearly, updates this $X and But So the above and lot be and we'll more a more continue uncertainty, have we agreements year. monitor there's number of

Kevin Hern

for thanks your Greg, Josh. questions. Thanks,

Next caller please.

Operator

Bernstein. Next, Please we Ronny go ahead. go to the line Gal with of

Ronny Gal

tradition nice one will result, about Congratulations asking donanemab on on of and the continue one question I other. and

data So see kind is the of it like program, could and FDA provide look that internally your question at earlier I the is, elsewhere. removal can guess guess support got in not a the model of on trial related or some modeled correlated confirm sort one assumed support assumption you some looks plaque impact of year to that kind based you removal can there you've that of When your that have you partial is as sort in. well from And is donanemab, on you before you a that for the the is entire from the early solid prices. As are is bar was of enough I be clinical that just trials. to the from understanding plaque for benefits approval a use an I action XXXX. there non-donanemab issue back elsewhere? for data I going the The want end of to partial but might from increasing signs go full this to XXXB impact question, year, you

Kevin Hern

Josh. go and Thanks, to Ronny. then We'll Dan

Dr. Dan Skovronsky

going. a I support can think the And It's Ronny. really decisions? strong be which that direction question here? how regulatory biomarker Thanks, certainly to that's how the field asking, the you're used good that Yes. evidence is is is

ones read analysis. So removing between a across in study correlation better the a do and a that this didn't that I other the primary had endpoint get when when even sense that removal antibody totality the statistical is trials words, on general all its hit cognitive positive have there's of look has out, again, the that plaque you pre-specified performance. the you evidence, plaque But look in that, across that other of first

and plaque we clinical significant removal very plaque the have fastest, a effect. deepest meaningful probably removal, the Here, most

point So removal it's plaque comparing in of trials. and cognitive dose amyloid sort another curve this across response changes different

there up. I for to we gets Are take have certainly and something removal additional become important think That's know. continue further regulators today? and As further the for filled experiments, I many out could aid will and of that plaque and for surrogate in the that someday amyloid in we years could that question approval a an drugs. by don't believed field regulatory

Kevin Hern

Thanks, Dan. Josh?

Josh Smiley

Thanks, Ronny.

reason up. As to a that the mentioned been very clear is the we're in the want patients changes providing that we made. to XXXX a the guided discounts price as We've three-point don't XXXB and that change that two- we've function And get. for of XXXB I cleaned on we've to reformed needs earlier, benefit be program

will discounts. assumption insulin the our can changes. We get XXXX, patients' So pharmacies ensure we discount. and mentioned want I in contract pass-through as that -- also to have to be get earlier, for is the Whether mechanisms there

there changes that the changes. year, as or modifications for there ensure administrative will work that full So not in if the the through be we get we're a assuming our to year try the some XXXX are of benefits to -- full or patients in benefit either discounts guidance financial legislative

Kevin Hern

Josh. your Ryan, Thanks, thanks for questions.

Next please. caller

Operator

Vamil Our next ahead. Divan Please the go question Mizuho from of with comes line Securities.

Vamil Divan

Alzheimer's I theme. So the couple a have on also

positive on trial, one, other or more results. the into improperly X, Alzheimer's, TRAILBLAZER much might the second maybe you But have placebo second drugs, So not excited. then response with trial. CNS getting manage Alzheimer's patients you but get the issue these gets just we've an the Everyone to as seen of in

being you say the have anything doing second have? or to trial carefully if wondering more to just getting Or patients who you're may I'm trial, there's don't So be the differently otherwise that shouldn't for you sure make my partially of the Phase scale especially a manage to guess then a I. placebo related are CDR the And second sum but endpoint like the clinical is rating to response, sort of when questions unrelated, I boxes?

you that if terminated. mentioned from to share decision. I'm just can any wondering more behind where details You you that

Kevin Hern

Vamil. We'll those. Dan both go to Thanks, of for

Dr. Dan Skovronsky

point Thanks, a good Yes. you Vamil. It's raise.

been pain course, trials and seen something is in stronger Of in studies. sometimes that's effect lot placebo getting in second psychiatry a the

that is some you disease. out, not to such -- it's allow sure signal I us. us encourage Alzheimer's encourages would strong thing maybe pointed a here in effect and if I'm there us strong that is see a here, One As even two think things that of

of given the is magnitude X said, bigger. seeing test small hits in and much is TRAILBLAZER as I First the that overall, which, trial effect we're the

the all time the That's methods. see which That and us other research immune, we as Alzheimer's points tau the your second endpoints from respect question, for gives now. confidence statistical this molecule. therefore, we here is With from was tau Second well. across program our to and additional consistency more AC candidates pursue with promising probably And immune's AC right decided X to we terminated platform. Phase

Kevin Hern

thanks for your Vamil, Thanks, questions. Dan.

Next caller please.

Operator

from Gould Our the next Barclays. comes question Carter with line Please go of ahead.

Carter Gould

safety see color key X out that on any additional will an the on you with Any Alzheimer's Congrats anti-tau progress. if I you've pain reading quarter, towards And then of particularly I just momentum guess commentary get-go studies tanezumab across inhibitor? longer on work, the if inputs X those X or view data? Phase a approved? represent got there Dan, approaches up you confidence? guess to keep level in portfolio first how with talk a antibody. number the had And your good trend of combination Phase donanemab, the with your with of regarding need decision I novocaine epiregulin your and the Phase that's around data longer-term first. you you And can coexisting

Kevin Hern

Thanks, Carter. Dan?

Dr. Dan Skovronsky

Carter, Great. two questions. interesting good

So Alzheimer's, purchase for on the future what of combination do think I that's holds.

clear One that of of are taking is drug. plaques this their amyloid about don't that drug of We know rest amyloid donanemab until be plaques, for the back. plaques anticipate we the not a things they're removed. will lives. stop is This patients treat treatment that Once really prior from come just we neat we with data

another for could a complementary, That amyloid or and imagine immunomodulatory you treating mechanism. with then drug can anti-tau Alzheimer's patient clearing disease. drug example, an So plaques for be in them

space. the something momentum pharmaceutical that the in will we're noting certainly future. pain an Thanks that's by likely So area for is This pursue quite considering and in is so underserved the that just industry.

held in because greatest drawbacks think I investment one an that see in is there's know to patients variety doctors the have of needs. we area reason the back current a thresholds, therapies. -- why of including that why pain. And represents number patients unmet reasons they're regulatory one medical This

actually steps, a this treatment funneling tests is the efficacy designed molecules here, not. but keep test indications, confident strength molecules get designed out. and platform we So well inform which whether we're have study, the study And can will multiple results next of or effects can in on to multiple Depending we that meaningful pain we against that --

patients said a towards large of and regulatory holdback heavily of resolved tanezumab, and in many discharge. which potential so signal to studied I that typically, here for the pain, a that on is well-understood a the safety course, And safety. be needs takes a perfect both patients as bar, with example weighted to Certainly, efficacy Of before, FDA. that number is

Kevin Hern

Thanks, for thanks questions. Carter, Dan. your

Next caller please.

Operator

Next question comes from ahead. Berenberg. Please Holford with go Kerry

Kerry Holford

left couple from a Just me, please.

when talk more gene lead question more we I can the And about then this however my indeed, is see decision for What Prevail. here. on acquire And in is housekeeping Firstly, to assets? others? their just nature. these particular versus if come the might see might to platform market? you wonder therapy strategy And readout when we data potentially second

You in QX. benefit talked stocking about a

you'd was whether the next unwind drugs expect you think it primarily detail quarter? I an million. that Could and which impacted $XXX into

Kevin Hern

the then question. Kerry. Thanks, acquisition for Dan on stocking the and the It's question Prevail on Josh

Dr. Dan Skovronsky

there's synergy great Yes. picked do gene the clearly therapy why I neuroscience. is are think we we of strong This great extremely work we platform. Prevail. at with We're Why two -- excited Lilly. Thanks, Also, just and a a really in have picked natural the We're join to Those Kerry. Prevail reasons really Lilly. team. a

sense gene what's here to our commitment therapy And a two be disease treatment in enter GBAX and in is approach, to the deep begin therapy from phase mutations, clinic to it’s areas we the We neuroscience. programs therapeutic have kind for we it thought data to as Prevail important a that seeing got gene future, and to already. efforts Parkinson's gene There's and has of an gene in of believe forward made space. exciting GBAX point therapy, therefore, One our validity looking entry the about across a into transfer. that. will with lot modality we're

The well-validated other that's And exciting. similarly I think, frontotemporal dementia in with here GRN also, target mutations.

very in -- these we'll time think programs first time see the to We're and to are lines. few what terms the market, port showed In patients data of it's those here, in just early. have lines of I still

Kevin Hern

Thanks, Josh? Dan.

Josh Smiley

unusually at said you of concerned we've that. Kerry. XXXX was just Thanks, versus year higher. not is Yes. when levels XXXX days inventory the million inventory On we're look look at if low of you $XXX We're QX stock. about in XXXX, what an inventory, U.S.

-- went through But some across I products. with in So the We And the look QX extra one bit little oncology. you see and also we imagine, volume expect a burn as January it's would We of do some function that the year see is Taltz win see in X. on XXXX, is patterns as did is on we But Taltz, function line $XXX in the in of purchasing the will ESI expectations. now that'll as think we into of a of million into for this Alimta. portfolio. increased our anticipation Trulicity off. that $XXX the a some effect go And of million

related some pandemic the in probably are think which but infused those was I products, on. see where two delays some we products of and biggest this the to

So we as would $XXX does. to million that burn in expect normally off QX it

though, were remember on make stocking a to other want million we The up build we customers the aware is, saw basis. QX last was year $XXX investors in that of were a anticipation in pandemic. This walk-downs piece, worldwide inventory the in with coming that as

if those year-over-year I when headwind concern -- do to to something. two we that piece. So up on and but that's that's year $XXX and of do $XXX you last growth, you could we in not about think the be year, think how assumed put Again, to million it's $XXX just into together, or points year, this compare the what million be things to a want million build build six about burn investors we remind

well. throughout this the bamlanivimab that year $XXX expect I have we million strange we sales we're QX, Remember Now in as -- going think to significant to and year, some in sold compares. have

expect we the underlying go growth But So an effect we'll to business, on see you in negative tease as that through. QX. inventory all base should

Kevin Hern

And for now to question. go the we'll Josh. thanks Thanks, Dave for close. Kerry, your

Dave Ricks

over innovation the of portfolio readouts indications. broad mirikizumab year of number industry-leading a Thanks, marketed important as year and team. interest But We're this set Kevin, year in our opportunities the excited Alzheimer's Company, a a for was just everyone's participation of important well and we in well. in believe diversified and upcoming reminder, be weeks XXXX. tirzepatide today's related in A to of XXXX as call, readouts anticipate we with this for for coming pipeline, for and Lilly. strong lot and continue today. three and have about the investment. and we baricitinib, sustained well months of a to that as course, questions five your as products to our lineup The we ahead has Company patients. Great. an immunology lebrikizumab in compelling two, and With for appreciate strong We additional Eli a

care. a great Please questions and weekend. any for team, in. a with everyone dialing day hope the have great thanks Take additional IR has and you So follow-up if

Operator

conferencing service. today. for for does and using gentlemen, Thank conclude conference and that you. our participation for your thank We you Ladies AT&T

may You now disconnect.

Eli Lilly and (LLY) 29 Jan 212020 Q4 Earnings call transcript