LLY - Earnings call transcript Q3 2021

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Lilly 2021 Guidance Call. At this time, all lines are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] And as a reminder, today’s conference call is being recorded. I would now like to turn the conference over to Sara Smith. ahead. go Please

Sara Smith

you Company’s Thank Director us Eli for Investor Good Financial for Guidance and XXXX Smith, Call. Lilly Relations. morning. joining I’m of Sara

of CEO; Dave Joining Skovronsky, Dan Oncology; Lilly White, Lilly’s call Ilya on Anne of Chief are Laboratories; of me Oncology President the Chairman Officer; today’s President by Naarden, Chief Van Diabetes; and of Jake joined and team. Lilly President Josh Research Bio-Medicines; Relations also Dr. Officer Yuffa, Smiley, Investor Mike at Loxo Mason, Lauren We're President Financial Zierke of Ricks, Lilly Lilly Lilly. Operating

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

could those of differ results to due factors, actual noted a X. including Slide number Our on materially

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

measures. As we our I’ll financial remarks, that commentary transition will non-GAAP on prepared our focus reminder to

introductory Now, over Dave I’ll comments. to turn for the some call

Dave Ricks

year, and were year as grip would challenge shared Thanks, we unaware for last coming and different At our globe XXXX would XXXX. XXXX, for reasons financial the unprecedented for you have been Sara. we us a ways. Company, pandemic has time the strong this than Lilly guidance Eli but perhaps of imagined in that in

the reps the towards next field were sales scientists Our working lab selling products. their the in in discovery,

combining world. where each caring Company's never manufacturing depend were to worked, up innovation with with producing even as new for makes deliver some A years ones address XXX medical filled for the expertise work design what in Lilly changed combat were by purpose out over responded medicines Eli risk tirelessly, effort But to COVID-XX that we we seen privileged and that all time months, cases But hasn't investing we and and unwavering play make patients stepped pandemic. in at can was for headquarters ways we what were that medicines to on is a in our within our the year difference changed on. repurpose XX worked, what this later, that the working better treatment pandemic. how around and plants changed, We to million new commitment continue past corporate to and the the and life develop resources and people we that employees for we've our to existing deliver global to patients and the year. first Our scientific COVID

many to this to all the continue a despite doing we were the we brought While virus, what pipeline do our on COVID-XX deliver makes fight innovation challenges by and the that patients. for difference Progress and we pandemic, do.

XXXX. prove Our our responsive and and people in business resilient

growth launch XX%. for of the HFrEF class by more Taltz, high-risk, with the its a approval long-term our exit Cyramza, momentum, new-to-brand received of to positive the over significant HR-positive rest XXXX having year. Jardiance additional readout for see fastest-growing approvals X, this throughout had of increased our classes share XX two early increased heart launched cardiovascular We events and exits its then diabetes, all in and as high-quality approvals in positive, differentiation a in of Retevmo, HERX-negative for year Trulicity Olumiant, pipeline first-in-class on positive As market year. failure you population, of Lyumjev, NILEX year readout points that cancer in its indication provided we in first Jardiance, Thanks readouts well outlook. breast than insulin since with and catalysts Lilly productivity can inhibitor, XXXX. confidence upcoming Slide and in medicines an leaders psoriasis, of and to diabetes. to submission doses RET the ultra in ulcerative and to rapid X Trulicity XX also delivered look a period colitis of market Trulicity the outcome positive positive XXXX. number addition future the the the with continuing from Phase for label, sustained with Verzenio This REWIND the forward the outside from seen readout have in study a mirikizumab affirmed we R&D and

this, a ways. we together month emergency update. In for all baricitinib readouts COVID-XX address our many shared and hours has Dan hard added in top fulfilled addition, received in purpose which lebrikizumab as also company to bamlanivimab use On Dermira. pandemic. we our worked will In this from data finest Phase our cover we been portfolio acquisition further among the of X XXXX, for our tirzepatide, in and LOXO-XXX authorizations of R&D and exciting We what his to

We a are path, of particularly obstacles year tremendous growth by and productivity underscoring prolonged the our new made period we many amidst ability medicines. progress our launching this the of proud in pipeline to maintain

financial to guidance. turn to our I'll Now call provide the the details over Josh of XXXX

Josh Smiley

good Thanks, morning, everyone. Dave, and

our the be And on we quarter each through potential for that impact line into we clear new investors our unlike XXXX, these sight therapies. insight We therapies. a As of with range broader provide there business. typical as a we guidance, of near-term walk recognize through and performance will of outcomes the impact move for revenue on their product for income much Lilly, a is our statement provide we'll of XXXX underlying the COVID-XX

over deliverables the of Despite up make see strong growth utilizing of Slide expect to and in XX% moving products, framework. driven guidance high worldwide by revenue X, challenges volume revenue. key our level our XXXX growth of So strategic our double-digit headwinds we a COVID-XX summary expect global we continued pricing you'll pandemic, XXXX, our growth will which from

delivering approximately XX% of margin We also non-GAAP in base plan operating in XXXX. to our further expand business, margins

line strong roughly expect improvement We SG&A disciplined top management, with point over generate basis to combined growth, XXX XXXX.

year patients, Verzenio early from Boehringer with to for ejection with cancer; speed Ingelheim; and pipeline failure include: reduced with to to tanezumab Pfizer. severe continue fraction breast HERX-negative the for heart for potential highlights medicines collaboration pain in collaboration Jardiance HR-positive, high-risk, moderate for action we life-changing in regulatory osteoarthritis As

data and for potential Additional readouts X trials zagotenemab portfolios Phase X Type diabetes immunology, readouts Alzheimer's proof-of-concept and potential donanemab our and Phase program; from mirikizumab; and baricitinib, and from in in early-stage submission neuroscience, X Phase SURPASS Tirzepatide's multiple for X from for immunology studies diabetes lebrikizumab oncology.

pipeline. thoughtfully we We priorities. to funding and new strong capital deploy marketed deliver focused allocation robust products, which launches, across Our our will outlook continue replenishing will flow, remain on opportunities existing cash lifecycle our our

leverage Prevail announced will with We Therapeutics. opportunities to prospects acquisition and bolt-on augment as future to licensing growth our our with of external continue acquisitions this morning demonstrated innovation

XX% ahead. the We development in a still year, increase reflecting our dividend This leaves conviction XXXX by dividend our in growth will ample for the consecutive outlook performance opportunities. strong capacity our business increase years third and and for

via dividend, amidst we another and strong long-term to financial expansion, enhance in to our excess year prospects expect continue continue In we our pipeline addition and growth investing business characterized progress pipeline maintaining operating opportunities to top to total, investment performance. growth expect return share strong and we to shareholders the and robust cash by exciting development to funding enhance line be while repurchases, XXXX In and ratings. while grade margin to

Moving to X. Slide

see a our You XXXX may which can number factors, of impact financial results.

help XXXX, from the experienced Tyvyt, all Jardiance, achieve continue also the Retevmo. or persist access these in Olumiant, those impacts demand products XXXX. Cyramza, new context, the therapeutic With recent U.S their year we products. is spur do new key the drivers in Emgality, expect significant expect classes, commercial we pre-COVID to authorization performance starts XXXX, and pandemic due first-half the While could of have reverted that to near COVID-XX maintained of cases growth execution health business normalcy our of Trulicity, expected including through systems that Taltz, to improved to to the to vaccines in baseline the of that expect in to suppressed in care revenue surges the second-half growth return in which We're therapy we scale, not strengthen across COVID into Verzenio, growth the of to And of the pre-COVID Against already. and successful deliver as pleased backdrop, XXXX. those levels

in For the We've patients in seen weeks. class XX%. patient Trulicity, of we GLP-X growth slowing we starts muted growth with to XXXX. new injectable class in began close year recent teens starts though the as near the resulting pandemic U.S new the has high acceleration But

translate and expect of they XXXX. momentum reacceleration remain below in baselines, continue While we market the mildly to a growth pre-COVID to

the outstanding and by strong expect full be we label cardiovascular REWIND the access update outcomes impact accelerates, year the As market doses. to class of share augmented and additional

continue pleased win we we next Taltz performance Axial performance strong access axSpA, of For at and medicine with the [ph] dermatology. indication the our growth Taltz, should the beginning in are in ESI drive volume -- benefit year will impact Non-Radiographic this our also increased the continue that year. rheumatology for additional full from Spondyloarthritis we as and to as improve

continue New several growth seen expect pre patient baselines, -- starts weeks growth past COVID we COVID immunology below and over to have XX% market the in about XXXX. but consistent remain this in

momentum in class Boehringer XXXX, look nears further have HERX in positive support added in breast share of by the points strong by are cancer it to China. presenting in the high excellent brand in in those U.S to the positive XXXX inhibitor we seen differentiation approval as growth. and launch momentum has We've the few of as Ingelheim, new Verzenio, over recovery past the XX% starts for five negative is Jardiance a that close the CDKX/X for with market XX% we share new in months, class pre-COVID a For collaboration to potential class in share and market readout Japan. levels. in the XX% delivering provided also in returned robust clearing We Verzenio HR strengthened in early are excited and continue that risk patient further CDKX/X seeing

chronic of in patient large first months believe expect classes revenue doubled of the We the outpacing and SGLTX in than greater additional script from disease the who headwinds there class robust Emgality pre-COVID heart class have New baselines, with introduce populations XXXX. experiencing This injectable many starts other remains U.S. while the pandemic. growth which in Jardiance. despite class to growth has the more growth class XXXX through we to than returned CGRP patients the in SGLTX during could benefit X chronic kidney opportunity lead diabetes, significant the could acceleration is failure X further largely Type of will

outside meaningful dermatitis China Olumiant continue this will U.S our Tyvyt trajectory scaling as stronger But in since doubled CGRP China outside be patient starts in September U.S growth the we our atopic revenue will strong products All will approximately continued therapies. Emgality the and in its of from Tyvyt have for the more expect key and XX% antibody growth growth below baseline. subsides, strength approval over in believe XXXX. XXXX the these drive will products we a Europe. year-to-date sales growth from our XX% which than to expect remained of impact continues benefit excludes to revenue, expect the We COVID-XX New growth. potential represent indication business launched we in and in from sales newer base market contributor pre-COVID XXXX. recent XXXX of together, class the

of to noted continue in growth addition Taltz as potential to from earlier, to Jardiance, launch those we look continued approval China Verzenio products forward and Olumiant In and scale. the Trulicity,

to U.S XXXX, we in to and in result decision as our but points tailwind we for diabetes will primarily adjust our the At on throughout We accordingly. percentage program expect XXXb moderate a of expect U.S. X roughly limited developments in business, a present, implement benefit a monitor distribution of a the year X price

variability of years in As do and the past XXXX. you expect all increasing been that few we area continue an mix over know to has payer

time, this other and segments VA pricing we combination year. Medicaid While overall DoD, across impact this of of XXXb, is shift throughout expect at our estimate the the to government

booked from year-over-year first growth the as both And existing productivity we as acceleration finally, the new utilization In and the on of from XXXX. new revision of Tradjenta impact the in continued we revenue navigating year expect XX% see from by down addition, efficiencies gains of the commercial medicines learnings with Lilly of our the to quarters of launch pandemic. our portion over alliance we'll well sunset currently capabilities Ingelheim as other of the three from realize digital marketed with scale and Boehringer footprint the ones, negative

in I the mentioned, to of growing headwinds, continued the from persist of demand first impacts cases terms surges into XXXX. we expect half as In COVID-XX

in a the expect XXXX. with continuation net that pricing trends also of recent declines single-digit We globally price we've years, mid in experienced

we that excellent list price we As down mix, partially U.S., offset rebates break expect driven underlying segment continue as maintain to access by declines and the by as across an net the to regions, mid increased as modest for single-digit well trend, price increases. specific

on mix. With XXXX. to in health intend from pocket on from the XXXX additional changes. which and This and call $XXX approximately reduce our segment fundamental we discussion with million solutions, increase reform access low health on actively our we'll to update the Washington of patient significant care earlier, on present, we remains earnings care effect impact we any this includes translate for mid for We're impact as any to not the guidance guidance single-digit mentioned expect increased would new unemployment XXXb to earnings out our There calls in outlook million of at price of and and developing to declines noted $XXX administration quarterly U.S into engage potential regarding factoring reform, Congress costs. QX XXXX

will level offset total in U.S that U.S experience more volume access this I than should time, to note by Taltz be win for product the due robust Over in larger price increased XXXX increases. specific headwinds price pricing Regarding ESI. our decline portfolio would at items, expectations the a

declines underlying maintain open For Trulicity, partially to price That access call on price the high our by moving by our offset forward. we excellent driven expectation single-digit noted in mix segment is increases. QX U.S and modest increased of trend rates list and

moderate low the However, to in Trulicity's likely high on in impact single single-digit trends XXXb of digits. the will decline XXXX, underlying price U.S

half a Japan, older price cuts to in Moving legacy for expect first we impact price of decline driven products. the single-digit low by the XXXX of

We anticipate historical price price new We a expect driven a the than China. we've China, to in with decline, placement experienced single-digit NRDL. mid year, which we do expect the by NRDL multiple in inclusion this products on was in decline line Tyvyt's Europe In trends. although the lower XXXX what double-digit of

volume we more gains expect However, price to than the offset decline.

areas, to in access on we to portfolio maintain focus competition in see revenue at price continue our continue our While we therapeutic volume we'll driven to prices and good growth. expect XXXX, for reasonable

to XXXX. of of trend in collect next we billion $X annual average XXXX. million headwind expect in expect expect collective and exclusivity loss XXXX of this from Regarding as of approximately and patent competition an well exclusivity, we as a that total, compares loss LOEs between continued continue for and loss year. Japan, XXXX, generic [indiscernible] Europe Cymbalta pressure patent generic we competitive from in $XXX year, global increasing Since seen erosion a Forteo approximately competition to This -- as Japan. exclusivity in and we've headwind In

key obesity Type X for outcomes program scale we trials investments stage with with driven program. assets program the year LAXO-XXX, see large we of R&D the and by tirzepatide atopic up expense X Finally, X late a diabetes starting of and in lebrikizumab full continue the study, Phase will the cardiovascular including initiation Phase additional Phase to X increased impact up SURMOUNT dermatitis as

XXXX we'll move provided background, where view that with X Okay an guidance. to we updated of Slide

the the we've agreement announced to in bamlanivimab U.S XXXX, to early of purchase For $XX.X increased December. range an driven billion additional due billion, sales to government $XX.X revenue the expectation increased by with

part late likely that December. of bamlanivimab to we're be will range, that low in on middle While in shipment believe depend we to the

in year-over-year, impacts experience business cases. eroded discussed continues we -- in recent again, in impact surge some COVID, has to emerging growing see base growth total the October, from COVID-XX our business from As and script we our weeks U.S pharmaceutical as

haven't the While we rheumatology. world, brand dermatology and like we markets migraine, around or achieved total growth in recovery GLP-Xs, state see new in steady key key still prescriptions in segments to

points income gross impact XXX margin, R&D non-GAAP COVID we that already slightly non-GAAP operating expense percent Moving XXX of dilutive our on expect of prior of accretive impact on guidance. mind and we'd basis basis have margin sales to keeping statement roughly points slightly $XXX therapy down roughly bamlanivimab the provided million in in a a XXXX

Our remain unchanged. GAAP margins

our range our valuations unchanged, we've while reflect therapy range to expense, remains Though could fourth increased between $X.XX range. range share valuations. per quarter. significantly of high likely an Those us further market projection and we fluctuate per R&D For to in exceed $X.XX year, total of increased share the to accelerating of non-GAAP are the we on that of is COVID-XX seeing for $X.XX end translate in guidance our $X.XX spend to [Indiscernible] equity that the range investment now GAAP. the share based recent for gains to development per drive changes the EPS can and end to

As and first we third exclude the change, months equity anticipation in from have this of the posted of XXXX, In investments X this losses revised XXXX. non-GAAP quarter workbook earnings measures. during from securities sight the to line impact beginning of XXXX clear gains and for on enable will we non-GAAP we a call, announced our in to removing of investor our

XXXX of equity reminder, when report for losses. and earnings As results we financials our gains reflect a non QX will still investment our in earnings GAAP January, inclusive

when order on OID gains we the comparison investment apples-to-apples EPS an XXXX XXXX with what of non-GAAP addition, from in to exclude help reflect with Guide. equity Friday, updated we our our looks like In guidance impact non-GAAP and

gains with guidance to the guidance OID initial will Slide you of X, XXXX removal moving our EPS. investment equity and So XXXX from and see

and to Using this our the is XX% XXXX includes guidance, XXXX the revenue the XXXX growth and $XX billion midpoint between represents roughly expected $XX.X small through billion. stepping uplift foreign of Okay, be from a exchange. and lines of various ranges,

driven than by revenue which approximately more in $X XXXX, underlying therapies COVID compensating XX% for includes price expected headwinds. to from $X to billion range is XXXX then for Our roughly growth of volume billion translates to entirely be the business. This growth

in $XXX we Phase navigating $X.X efficiencies million from in [indiscernible], for be to roughly initiation to products of investments capabilities investments the we Research of pay we utilization approximately XX%, driven our points of to therapies. by in be expect $XXX a percent footprint do Moving spend Net in selling of a basis, includes therapies driven gross we COVID-XX of as R&D commercial by LOXO-XXX from as income be from base Marketing, X tirzepatide, digital the amortization both COVID-XX basis program. other at and partners. XXXX, margin of dilution be realize increase of lebrikizumab, the range decrease increased XX% XXXX reported expect in expense On therapy expected royalties approximately roughly including marketing $X.X with of year-over-year a in administrative driven mirikizumab the This expect billion billion, the margin increased we and percent non-GAAP billion. the is $X.X expense reflecting development of down and Phase revenue continued and range XXX by unchanged to expected on business, increase million to X COVID-XX and with as in a the statement, our billion investment to a revenue to a and basis, learnings to pandemic. to key gross intangibles accelerate existing of XXXX. modest is double-digit $X.X a

meaningful are value molecules opportunities be about and to create accordingly. with to continue We these investing the of each excited

is the of and $XXX of a operating and our expense and about margin strong basis expense. a operating guidance continued non-GAAP to On implies reported of approximately SG&A non-GAAP on other expected XXXX therapies margin neutral. between top largely be XXXX million Our COVID-XX impact margin XXX as points $XXX revenue growth percent basis, expansion prudent a drives income in line increase management XX%, to million of is an and

XXXX,and include As on gains a any or losses impact of the exclude expectations equity for the range losses gains a reminder beginning reported non-GAAP year. does basis, investment next not in will and OID investment

a COVID-XX U.S taxes, we Earnings per rate growth in includes to XXXX. range X tax is to on percentage $X.XX point assumes effective GAAP in tax double-digit of over $X.XX for our the performance per non-GAAP on Adjusting is increase through broad of current XXXX performance estimated top non-GAAP XXXX. is The place expected Turning XX%, the basis. per for comes share $X.XX of and therapies. be structure per $X.XX share which represents from that be EPS all and roughly impact XXXX a expected COVID-XX expect strong the non-GAAP impact share of This to impact in the share. strong range to therapies of approximately to of

Our be $X.XX GAAP share. of share EPS the to in $X.XX to range is per per expected

to For we approximately shares million, from your purposes, are estimating for external change a function of slight we quarter reduction two deploy XXXX. first This average XXX XXX of number to would a million out. versus XXXX outstanding share repurchases. amount currently point for could modeling XXXX are on weighted There the of diluted the be approximately as we investments capital innovation impacts the

we only the Taltz from on the are provide new First, very revenue Taltz ESI a via for will and rebates should already volume ESI but growth, also positive other not prior the win patients exceptions. while impact impact who provide access authorizations utilizing business,

performance high during and we XXXX, high arrive XXXX, in margin XXs in increasingly significant outlined in in our we quarter, after mid in We're with our this and the challenging through be guidance expansion expansion a operating XXXX at and expect outlook deliver to given the impact top we the the margin muted XXXX ability COVID-XX non-GAAP the year. are of our accelerating of level our year revenue growth line with Second, we amortization to and expansion XXXX pleased of throughout confident of intangibles shows first operating revenue stocking our the percent tier quarter the experienced Slide for with growth timeframe. XX in impact to growth guidance. X-year margin benefit will first top

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

Dan Skovronsky

to is now availability other care America, potentially pandemic I'm people resources for in the doses in year, most we slow progress. Bamlanivimab several the for encouraged health also countries on I'm impact facilities. use excited Europe didn't that North Josh. and our patients opportunity and COVID-XX we available to help waver efforts from XXX,XXX suffering pleased world. our that about commitment around distributed trials, throughout the the also and the despite we United therapies, hospitals clinical authorized of more to is COVID-XX significant additional this other in with growing and our decision to our our Thanks, than States East, on we're Middle fight, to with didn't all allocate bamlanivimab and diseases

for key At an summarized, assets, Dave positive and of In exciting events LOXO-XXX on cell oral important in Non-Hodgkin's our we we've mantle extremely leukaemia, inhibitor our highly data other small many two tirzepatide. weeks, the BTK had year we've lymphomas. shared non-covalent lymphocytic significant and productive data lymphoma, ASH, with chronic As LOXO-XXX, lymphocytic and disclosures. past selective, data lymphoma, presented

for more has excitement only and for them follow we As think longer, the drug this very has in program the and meaningful to patients. potential we be our treated grown patients

have a and underscoring envisioned. therapy, enthusiasm potentially B cell that that for expand our BTK the leukemias hypothesis was focused prior generating of in LOXO-XXX paradigms of LOXO-XXX patients for the Our entering population asset been for inhibitors originally regardless S since to that was mutation broader see and patient drug with with much transformed patients We've BTK CXXX acquired status lymphomas. on original resistance responses regardless BTK The covalent impact a hypothesis delighted clinic, this mutation. deliver to treatment

As tens drugs. a receive currently these result, thousands patients of of

patients. relapsed LOXO-XXX the these patients options important once administration. weak However, risk therapeutic on therapeutic or become may believe these complex new We option an either benefit agents, offer for

This all patients prior September As of were of date, were these received included one least XXX the data in rate and for patients see data On a XX% XX patients discontinued an showed therapy XXX have in and a efficacy overall median as to who the had as can any evaluable. XXX LOXO-XXX three response in Slide BRUIN response XX, from of study, of data These patients response assessment, assessment. enrolled patients. cutoff well you who at efficacy lines the LOXO-XXX prior patients first of CLL/SLL.

has been the followed with observed increased response covalent overall patients rate as longer. as the inhibitors, BTK Importantly, were

remains treated actively CLL/SLL chemo In ORR was our BTK, classes kinase other who regardless PIX consistent in potential ORR venetoclax. the rate BTK more or of discontinuation, does XX of and was this moment patients immunotherapy, prior not all available prior Notably months. data cutoff, reflect an for for in response overall therapy, the the followed BTK BRUIN all estimate months. patients, status, therapy followed As classes trial, point accruing in many ORR are time observed patients with of any reason mutation at the received. and once We patients similar even activity were XX% for or

XX patients the treatment months. off remained data longest XX% of on on cut continued the As nearly at responding CLL/SLL followed patient responding therapy, the and

Slide to Moving XX.

BTK therapy immunotherapy and patients of all responses in this MCL inhibitor. notable pretreated population, BTK given You'll had rate cell lines an particularly patients, The including mantle which from shows received and are XX complete options. XX% responses. poor patient had three of lymphoma, received LOXO-XXX patients prior with Enrolled overall response of prior see XX durable therapeutic data existing nearly a in with in and median outcomes chemo MCL

in patients in rates and therapy. in emerging efficacy observed XX% patients As important CLL MCL, of to of in Waldenström's macroglobulinemia remain responding lymphoma. striking It LOXO-XXX of overall home September is non-Hodgkin's other XX, response response and note also showed the that outside with

any treatment events. tolerated been for we've of toxicities, patients not adverse treated related only safety maximum LOXO-XXX. all We've identified. with dose far, pleased X.X% limiting observed profile a Across discontinued to have not has So due patients and the observed dose been

also attention rarely date to inhibitors them covalent adverse and occur. close seen associated events with the pay frequently have We to BTK

Phase robust agent X exists studies, superiority impressive CLL the results BTK as patients. ibrutinib Given head continuous versus In our trials establishing need preparing inhibitor, in on designed we in one the in unmet shown program LOXO-XXX as for MCL first MCL. and include or in covalent rituximab. of on a generated initiate XXXX, development clinical the BTK and XXXX clinical One we'll patients CLL focus comparing XX. line to will idelalisib also and in significant a monotherapy The medical plan in four begin pretreated plus following to plan to with trial disease preferred to plus we've relapsed will investigators and a Slide development CLL. begin to LOXO-XXX head as LOXO-XXX, CLL, bendamustine In rituximab global LOXO-XXX we're two choice study three with

second with study in start [indiscernible] expected regimen trial. LOXO-XXX the limited the difficulty] in studied trials trial These to X-year [technical to first a The time half regimen added XXXX. of in the two are

in trial XXXX. investigators The is first to expected of of X to patients of relapsed line versus LOXO-XXX a in in head-to-head head-to-head LOXO-XXX CLL later initiate BTK In refractory study we in covalent start choice MCL, plan XXXX. inhibitor early Phase

malignancies XXXX, opportunity will in for with data, encouraged the our require about benefits approvals and excited approval, further to accelerated the can submission very LOXO-XXX be accelerated we're recognize number to a second potential submission launching timing. NDA We look of to forward indications. with we hematologic of program for the that across these discussion we and quite potential and half single-arm for X commit with by patients the and regulators discuss Phase FDA the plan are While challenging, can or before

on delivering first We're living for our with the our Phase XXX-year delighted receptor people to of diabetes, tirzepatide. GIP/GLP-X to Moving nearly heritage for with X readout build agonist. to innovation continue

to Slide XX. Moving

in our patients we intentionally diabetes Call of can designed last impact tirzepatide program SURPASS we X with treating month, a noted to positive we Investor broad enroll diabetes. demonstrate believe have patients the with As the range in Type to living

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hemoglobin doses also diabetes. Association Slide with XX% achieve people to American nearly which three XX. hemoglobin of of to all less is Type Moving Tirzepatide X%, AXc the recommended AXc for X enabled Diabetes target across patients than

over Type X.X%, mark in level impact seen is on The events glucose encouraged this XX XX% X X a an disease. XX and people diabetes. is below of patients diabetes milligram important of less new assess with hemoglobin XX believe no X or hypoglycemia level tirzepatide a per HbAXc AXc of finding patients We're of doses largely milligram fail of these without achieve levels this We Additionally, to hyperglycemia this glucose the chief improvements saw than in severe in milligram to diabetes treat Today, arm medications. Type an measure were over deciliter. XX% of unprecedented that target. achieved significant

their if course, provide for results, diabetes them options are perhaps in these could achieve potentially tirzepatide, treating earlier patients With physicians who levels. approved, glucose helping normal

similar established The moderate adverse the agonist and events to well to reported receptor GI Moving profile most mild And overall was related safety GLP-X to class. commonly Slide the XX. severity. were in

We X patients. tolerability that stepwise dose for to milligram events and are implemented contributed we initial discontinuation X% our this with adverse each dose it X.X by may new arm. impact were look than very of have due starting a low improve schedule, program, in Treatment encouraged to Phase how the at less the potential escalation for dose of

In doses. vomiting addition, of across nausea, diarrhea with the comparisons, all the trial showed rates improvements three acknowledged and encouraging limitations cross of

arm rates showing further coronavirus treatment withdraw the to We related a the treatment program. release and dose why be discontinuation new rates patient readouts On majority meaningful were schedule the Examples reasons or press across may from data in There more With or set trials. than XX reasons be concerns of other we a of line placebo improvement compared -- the rates the a a forward than the The the had in as treatment noted choose were observed potential a discontinuation in are quarters. for look milligram arm of events. of to with SURPASS the additional adverse the will reasons work We coming in in to Xb beyond may milligram to also discontinuation personal study. pandemic. treatment other the patient total the robust Phase the Slide we issues we monitoring arms events. all of escalation get family as generated that XX, and GLP-X discontinue typically to SURPASS-X We XX arms, shared reasons, for discontinuations number due impact a adverse outline can that trial that arms.

for expect QX. by We and quarter SURPASS-X in first readouts SURPASS-X SURPASS-X and the line top

depending combo is But SURPASS-J cardiovascular contingent of readouts submission is on of SURPASS-J on global expect a studies. for current pre-specified first study mid with that number mono XXXX. the half events. SURPASS-X, accruing also A event on and a We gating estimate or Japan completion rate. vary add could completion monotherapy factor for The safety of and

support have potential a also We indication. SURPASS-CVOT. ongoing an trial CV cardiovascular to outcome

CV outcome X against The competitor diabetes with CV trial an benefit. a Type first active

XXXX. on out contingent rate, While event to we expect by the trial patient read XX,XXX

to SURMOUNT-X X For in is program. the read broader out projected We program, Phase note three obesity SURMOUNT studies in XXXX. new forward development the tirzepatide look XXXX that to obesity for initiating we

I'm a Phase and fifth potential that start the to will pleased to the indication heart year In fraction, announce also patients with in next addition, summit program. X study obesity HFpEF, tirzepatide development failure with preserved ejection adding

We to data with today's pipeline are of these phase profile Prevail we're Dermira. acquisition year We X internal closing and preclinical the our be examples of the excellent efforts. from announcement innovation. bolstering excited external the and acquisition the adding began And through with to readouts, Phase high progress year early of two XXXX of closing lebrikizumab our Therapeutics,

portfolio therapy Prevail's of Parkinson's adds Lilly will this preclinical therapies ALS, our other and As area by clinical and research another we Alzheimer's new of modalities efforts, drug that disorders. and a deal by development neurodegenerative in program dementia, frontotemporal gene disease, anchored gene be for across promising build out creating discovery

pipeline across our In look made technology in skilled all augment forward carrying teams therapeutic and momentum expertise addition, critical year. acquisition existing bring Lily. next encouraged highly we've that of to at we to We're believe this into XXXX progress will We areas. by the

each lupus, won't cancer, areata lebrikizumab the initiations X, alopecia empagliflozin zagotenemab on breast MCL key obesity for early in colitis Donanemab and the Slide dermatitis. key tirzepatide XXXX ulcerative cancer. the data HFrEF diabetes. HR risk SURPASS While events Detailed data on positive Alzheimer's and and moderate high LOXO-XXX severe for And diabetes. for disclosures I'd you empagliflozin in progress XX, and data describe for year. tirzepatide and HFpEF. HERX-positive potential following the disease, disclosures on abemaciclib tanezumab and our early Type our SERD, including look in COVID-XX for other X, submissions for Phase listed therapy X breast They're X for and events. and HFpEF potential We I X from and atopic Phase Sintilimab our CLL, X for HR in regulatory Phase mirikizumab positive for options to these tirzepatide highlight keeping of X and coming HERX-negative including on to events oral atopic key combination baricitinib and SURPASS, for forward Type neutralizing abemaciclib for pain. regulatory for from antibody updated X and program sitting throughout osteoarthritis dermatitis X

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

Dave Ricks

Thank you, Dan.

Moving sum let XXXX. for me outlook Slide XX, to up our

revenue growth. XX% expect therapies COVID-XX double-digit Net approximately We strong deliver this to to translates growth. of

products to As growth. our deliver key scale growth volume continue and double-digit

basis expand non-GAAP to versus to operating projected by margin We will XXX continue XXXX. margins with improve roughly points

of we and footprint. As our current within scale uptake medicines new drive existing ones commercial

will potential initiate development, meaningful Anticipate throughout key of therapy For the raised third of regulatory have by year, combination COVID-XX outlook with we period We confidence have and business readouts of and we molecules readouts XX% NILEX. action data the look phase during proof-of-concept forward In generation a Yesterday the several a LOXO-XXX our submitting its sustained R&D, early and number X strong year. or best-in-class portfolio. on to number program. straight first-in-class we of potential our dividend this and growth. the reinforcing remarkable the our across flow for productivity cash the Phase

Lilly, knowledge one with are the that and portfolios agility readouts continue new lessons more which the purpose We entered We opportunities by from and in allocate persistence supported the in data industry, capital we and and freshest exciting excess our future pandemic. in to XXXX the ways. innovation emboldened XXXX by will learned job Lilly we have of capital fulfilled while growth to way. The profound displayed returning of shareholders. on drive the its have the the we

a customers, I turn remarkable deliver extraordinary And and are privileged back to session. our each day value to to now have before our us. shareholders, communities. our moderate will opportunity We our employees, we our Sara it over to Q&A to work

Sara Smith

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

please parts. we provide you with Q&A single question instructions a then caller. to into ready session Cynthia, two we're for So limit for two questions the first and the that the ask your

Operator

from Certainly. JPMorgan, your and the Schott first with is come Our line Instructions] of [Operator line open. question will Chris

Chris Schott

for Thanks questions. Great. the so much

on on results. been more to a for detail a specifically, from clear has two how impact Just want percent was as the distributions on I just make impact program XXXB I that first, your this revised large having business? the the me. bit I you limited I of have. sure guess, guess,

benefit maybe understood you're So with comments. in my mid to And I here. those erosion the where seeing Taltz. you be bridge just the I the a U.S make of low then to price single-digit want second sure versus growth volume pricing a have as of access. kind on to seems build This product question balance this always we headwinds question product just was

Thanks less a maybe looking much. think on for and of overall sales long-term, So proxy little beyond point on so Is more this magnitude here. to becomes we'll meaningfully and a growth bit as think better a greater as that's of And out overall a the XXXX, headwind a XXXX than just reach for pricing bit we look to this headwind need can pricing about clear about volume the little something just where we then portfolio worse? growth? or we franchise,

Sara Smith

We'll Chris. Josh go Thanks, both for questions. of to those

Josh Smiley

X% we're making to Hi, as X% a improvement of so Chris, what the thank is you, change On XXXB, a in function underlying yes, price we've XXXX. on said

settings, talked it's about a of segment. part our in this messy is we've -- As other

government-related and point this has is we've the been Medicaid at year. that estimate is we'll driver. we said part segment other biggest of about an that's the than growth segments and our business what XX% So XXXB across the during our when in and that of fastest monitor look mix, XXXB, entire

the you So that's numbers. get how at

in benefits the seeing change. fourth are from this We quarter

into forward those projecting just we're really, XXXX. So

happens patients what course, Of rebates, being course, I them. the to submitted have these who variable. it are is see with mean, for we of

benefit from as typically assuming point, think settings system place through price at XXXX But at don't they X% price X% but to in to I to other this how a they of have see benefit in by start. otherwise. reasonable rebates, well, migrate said any we've get in As benefit and we'll these one-time a sort the is

basis years, and know, a Taltz, you behind I both on as then to what to the over significant we're the last at For terms Cosentyx. launched Cosentyx yes, we’ve we relative a TNFs of comparative relative disadvantage in and perspective, few think seen

last few we Over are years a we, position with the I think, a to more favorable in upgrades, where position. moved have access

or to think pricing going decisions I will we to out play expect in dynamics forward, see make every look payer the normal each should year annual So terms of an on basis. dynamics few

that. So an we we'll feel really that a position continue, I downs from I access ups have good with come think, But think better the to in much perspective. about and starting XXXX

through So that, can physicians get prescribe and have nearly patients can going historically. it as steps Taltz had without many prior or they as authorizations

Josh Smiley

Thanks, Josh.

Next please. caller

Operator

line with of go We'll Wolfe the Tim is you. through open. your and Research, Anderson line Thank

Tim Anderson

on Question tirzepatide. you. Thank

level of and AXc patients So that to euglycemia. results or getting below, getting which X.X SURPASS-X -- is

You in to like-for-like published gave that range compounds. what saw surprisingly find the with you data It's trial. other hard for

a real a if was important could out both big was weight the trials? that maybe And bit commercial something a So to what and sugar, trying little front? different could on initial product, in because an benefit benefit? it subsequent suggestion Namely, know this in of you finding? moderate. starting guessing prespecified I'm then, anticipated very on that type might you And characteristics this talk a spurious? blood finding you trials, you can how this figure subsequent or just we're that whether was higher And I'm prespecified, be you robust that differentiation. baseline it see is endpoint see show was because to of this And about those is

Sara Smith

that to Okay. We'll for Mike go Mason question.

Mike Mason

beforehand. the for we Tim, that endpoint Thanks, obviously, that result very a important us in for And specify was question. a did

able to with had have products I Really agents, then of AXc approach normal drug you look diabetes, therapeutic never with seen insulins, powerful be AXc. you get people -- - And to that. risk -- small really reach If before to hypoglycemia. grail window, we've you With hypoglycemia. the a without enough at that's can the Type down a other holy X I been to get normal haven't Type is X there can treating have diabetes

I've I And which think from the a that data did seen in is head-to-head in XX% showed the versus dula. of dose. people the dulaglutide, tirzepatide versus X AXc X% XX we trial for to best milligram our Phase normal we with returning studies, over

we’re X diabetes. failure the this actually is know of do early-stage now hope Type will us in the living this excited to Type treatment Typically, population, And the so to and the I provide do But the diabetes. significant going that about this ability more fail. We with give success. treat that with people a products people opportunity they to milestone treat are can in X this play think offence

excited we're this. So about

diabetes, pertains the to who see with SURPASS-X see it SURPASS-X. we're later-stage for longer very with results X, people who excited how to studies with As when are and have duration do diabetes. we’re But what works and tirzepatide to thrilled can we'll from impressed out people measure longer very that

Sara Smith

Mike. Thanks,

Next caller please.

Operator

and We will open. Baum Citi, go of to your Andrew the with line line is

Andrew Baum

Two you. please. Thank questions,

price talk gets the at could But I'm know example, future the discussion. Firstly, of you non-Medicare care confidential, only patients. about on magnitude CDKX/Xs, the to that think list of primary specialist assuming some sense to LOXO-XXX and and trying Verzenio products Could pricing and to is products, oncology restricted like us approved. and looking benefits give XXXB diabetes. outlook the the of I up the for products, you for just it between it's to picking delta the

about two And on And the Many is? business. own what so of if importance then I'm trying the to Given there’s LOXO-XXX, voice, those pausing second, and hearing between payer magnitude Difficulty] way a I'm [Technical Redx my the us for is sentences. remind drugs, this think so apologize just to I thanks.

Sara Smith

We'll go the question second on to Josh for and XXX. the Jake question Andrew. for first Thanks,

Josh Smiley

Thanks, Andrew. Thanks.

spread, was portfolio, was XX%. across report, and do report for and it XXXX, our that, net the On our price level. just difference integrated – the between list we to price portfolio that you In at our total remind

between -- list difference So we number. was the price price at actually net of and XX% our achieved the net what we

look we the couple if Now, spread across that happen tends to in portfolio, different of a ways.

First, in they competitive of increases government they impose – their of above there as dynamics. spread for penalties our function thelater lifecycle, so a on products, price longer are inflation and the more all is,

is The the second the – majority is. then, price volume piece, where of course, the where majority the of of

in that more in commercial So the diabetes, competitive see to B, where provide discounts setting less that and a number you products classes, be in or spread our segment in see less. one Part tend We care. is in products managed in tend to dynamic you bigger

So you and much if closer between a our newer look list to particularly saying, at alignment, closer of oncology and products the think, we long much variance. much I products, have way net a tend wider alignment

Andrew Baum

expressly to get probably we’ll XXXB – the guess, I to impact?

Jacob Van Naarden

XXXb Well calculation is effectively the the mean, Andrew, impact what impact XXXb -- the price Medicaid. I is. that's

So idea. same the it's

big you get to a settings, in than a less commercial in between life spread long have has you product that If significant your what get government cycle discounts settings. you

for So you'll see sure products. diabetes in that

that in to any large don't products You see oncology degree.

Sorry.

Dave Ricks

I a Dan for There's question well. think as

Sara Smith

Dan, for think LOXO-XXX. Jake to we'll go I

Jacob Van Naarden

Andrew. Sure,

are and the XXX Your question, none. program the residuals I there on economic is, believe about answer to is [indiscernible]

Tim Anderson

you. Thank

Sara Smith

Thanks, Jake.

Next caller please.

Operator

with Next go we Terence Goldman open. and will your of is to Flynn line Sachs, line

Terence Flynn

perspective power of just the versus some? and this Jake for or LOXO-XXX. me, to … your based positioning then And Phase X on … chairs year. and head Dan head share either if for I could details wondering tirzepatide of assumptions any on on the commercial initial Two trial the Mike, you question progress was maybe data, another on

data, key you questions And you. the the here additional safety therapy breakthrough asset? designation? what for are Beyond seeking are the Thank outstanding

Sara Smith

and for go on then We'll Mike Terrance. for question on Jake the to question tirzepatide LOXO-XXX. the first Mason Thanks, appetite,

Mike Mason

tirzepatide. on problem solve the with wonderful Yes, results good saw. question a It's commercial patient we that focused and to

back to X it I is to now fail. comes right that diabetes treated Type think us, for

know going so you generic then typically, to use AXc. normal And get and branded people not that orals, to you are orals

really what see and ability is what normally, And to to potentially back so tirzepatide when those -- I see. the reset think, we expectations, reset for

we opportunity but X so think we're AIc not and loss, those really the is the good weight health option, to And living an Type also diabetes. overall with of only provide metabolic about helped excited this really,

about of product. So we're that very excited the position

the [indiscernible] to it questions the over I'll study? As Dan that of powering turn any goes the to on answer powering, to

Dan Skovronsky

And right. and will this saw Sure, a successful powered. All in and we jump Mike. confidence our ability naturally only the reinforces it's have what in our readout just I adequately study head-to-head. first to

Sara Smith

can go question to we I Jake think on LOXO-XXX. the for

Jacob Van Naarden

Sure.

that's questions longer, nature of treated an So of obviously, on what we question because I the of adverse on the what front that's more just as patients the data important will clinical for naturally the of context the think, of the outstanding happens program asset. the safety, are one, the a first sort about It accumulate in are events, trial. part you’ve key turns highlighted

Again, what the about only we've seen I limited long is far. But same how about say, ability will enrolled. outstanding where be stand to up good when so for what good duration feel the those point, nature patients question we're adverse think, today. we somewhat limited. follow we though, I another advocacy But we would us important that they’re I will simply follow the feel time of duration events remain had from grade, tell. by to etcetera, their follow time. of think To Obviously, we've are, that of over

learn context. we that in every So more day

or know piece that. covalent I today, I we And, our good drug think about feel like question. randomized is ask there. idea long-term, to will think against the generated lean the create is home say prove good ability important doing think, riskier but where the setting benefit its into, really feel much we're have let's BTK to frankly, we're far feel first much to head-to-head In the And place But what we that's post for the we we're think question ask. the the an think trials just data a run drugs nature it, And the and patients. proposition. trial a thus about asset, a in in, up very obviously, going why where last line most knowing we place which really where the even that the the I standing we obviously, running, to of to I CLO, riskier brutnib, of it's it's we

the we really publicly regulatory Your designation, second comment. really I comment question therapy don't around breakthrough of on so can't and ins conversations, our outs

Jacob Van Naarden

for Jake. Thanks, Terrance your Thanks, questions.

- Q please. caller Next

Operator

Barclays. of the to your Gould we is line open. with Carter go And Next, will line

Carter Gould

your taking asset view Thanks you to more about space creative congrats there's on franchise. you guys. almost of IMBRUVICA couple morning, commentary I maybe head do getting, this A characterize data. there. light the for foundational sort study? very you years, the ambitions and And sort not residual piece what X I so building on few I and Good Plus you HemOnc that questions. took in we as that, expectation potentially is guess, as Can then of minimal you the there sort can timeline? just the Jake. unlock franchises. fair mean, do [indiscernible] of and XXX to in out minus shorten to build single head a something HemOnc to X you. of extend Thank study a around. that future, disease against going we Is guess are too be your think that complete. can I Or guess distant using head-to-head the help

Sara Smith

ahead, Thanks, go Oh, Carter. Jake.

Jacob Van Naarden

important portfolio. portfolio around the XXX it'll the hematologic have make of having Obviously, today. not first sort first malignancies. question, into what We if the of we and asset an to as be Obviously, portfolio. nature foray decisions like try we product to company's we in And a of the Sorry, to in stand strictly malignancies, it's nice our every and another obviously but as axis for candidates patients. applicability evaluation, the boon new have being hematologic advance on overall can has we that's own as its externally, ultimately look meaningful that

level And apply we of still have regardless that we now. rigor fact same the that three or so five of

and portfolio of or of like. study, IMBRUVICA for patients think, of a And question patients natural product three that, in the will the of commenting be what our treated meaningful time one, for the without because long think I'll study directly the calibration say good. I about head I long on with take, the the ability the will rest history second to five company, setting looks regardless hematologic ibrutinib how our study the number a take first is line has

in study, certain And event a an survival of take and you'd long so driven progression number time free to events, need can happen. to accumulate a that

of and think burdens study design. are a I is that that's point to Whereas the be ibrutinib just testing calibration on is the out thing inferiority study different. important question a will superiority non so the statistical we the

designs. trial of types different two those For

the ibrutinib of you as main and largely proposition value like around know, safety. think, drugs are I [indiscernible]

is main profile and very think of has looks Fortunately, XXX efficacy. But good emerging very competitive. the XXX proposition safety that an we

Sara Smith

Jake, thanks, caller, next for questions. please. and Carter, your Thanks,

Operator

We will line line the open. Go your of Seamus to Guggenheim. with Fernandez is And

Seamus Fernandez

for Thanks question. the Great.

you're results, a next of gamma presumably not signal? if So advances just to the are beta [indiscernible] does from announced see year. happens at the program like a here. that believe study the what Are first program show And anticipated sense you what couple point. the out be what in and of which Hoping quarter space to I in Dan, hoping of to get a

give this a appetite, The question in the scientific of to you interested little path patients sense a obesity underpinnings bit see Can on truth half really of is second there us just other you that study. are is potentially that benefit early you anticipate of these of offer an seeing also, a But signal some program. your follow there. in some of seeing from up is,

abemaciclib. as the poor and cardiovascular the of The best-in-class, with give How's on much. view presentations? shaping you your your maybe some update if from us surgeon? then just combination that? so kind surgeon On anticipating could meeting Thanks front, oral up medical a quick

Sara Smith

Thanks, Seamus.

those? go will We Dan to for of all three

Dan Skovronsky

Thanks, Jamie. Okay.

with start Nano the I'll So [indiscernible].

that a it seen of drug amyloid we're trials we've going clear You're have our to going XXXX, efficacy. hadn't designed and in of read demonstrate Phase X is of in previously early a that plaques seen Well, are trial to out. study this results? both didn't matter can terms plaque right we that lowering this is trailblazer looking course, In amyloid been the degree study be course, rapidity clearance. to to the of What depth for in

So we if have of we'll on look clinical amyloid well. outcomes at be plaque data, cognitive don't studies, the on the for and we'll larix. confirmatory of data. would positive biomarkers, including a on And see signal, But effect improvements surprised course, if signals functional other back we for efficacy be expected we looking we'll looking if we as also I be for also Alzheimer's tau. That's will look your biomarker

of we whether slowing is the results. plaque plaque I And that mechanism. decline, the strength think population I or know doubt a then something there's, about think lot of pursue we loss. a think testing to including, this you're of go should we first a would why hard I pursue, we claring continuing ladder we but cognitive plaque of given forward. I clearing, On in path, course, benefits don't see asking to well, tirzepatide would worth not of if and continue all, would why, about tirzepatide, be this? this molecule think disappointing the see weight prominently

We fraction. cardiovascular the preserved also heart failure particularly with with weight ejection effects in loss outcomes, patients of know and positive

based we that effects extrapolate on expect as might to see. So of can we sort

we've is the that plus pharmacology outcomes were I on answer, about, and mechanisms here, talk an also on with us the think physiology tirzepatide do I from oral HFpEF? seen have other you we patients add to will tirzepatide. we've that before to based This opportunity the no. which asking, give of some in anything Jake maybe trials to you seen with our in Maybe HFpEF surd, extrapolation go Mike, other confidence that's directly gave

Mike Mason

need study No, important to as the about the answered is well. the you I potential than think in We're question no, marketplace. Dan, huge with, excited unmet which population a

Dave Ricks

Right.

medical Jake their outcomes. we think obesity, I important which cure to as various it less is see third. for morbidity is down thinking from patients, not expect for treat only important even mortality or driving oral, obesity failure. or around is into our including in and a general, lot ties you also heart diseases, And weight, it

Dave Ricks

Sure.

a a Phase Its position talked third. to 'XX. context it's Obviously, trial. about lot nicely it oral progressing in our haven't X I more around we'll we a clinical data, a in talk in imagine in the space. calendar be So of publicly data, competitive

happy we're seeing monitoring what as And far. so so well. what But doing we're our with competitors are we're

think, ad was driven a the into having CDKX/X know, portfolio that the ago, now I and that owning space was the you in differently strategically, strategically on we only oral allowed got more It's premise a inhibitor in And, with benefit year, because only circa one abemaciclib same an and of that begin become valuable. of setting. profound to that would has reasons the that with a with the in portfolio inhibitor think the year results abemaciclib And this think the be to CDKX/X in about of our [indiscernible] surgeon, half place the with strategic I has dynamic. just us slightly asset setting. competitive idea

next be par But to out. perhaps and obviously, on data we'll that competition strategic to surgeon more clinical at We think has space. be speak with point I some data plays in talk in well. position that So as oral to to with our a positioning specifically the year, safety for our efficacy some clinical competitive overall regardless, but assuming the like

Sara Smith

try your am. as questions here so thanks and to from your Thanks, to we Seamus Jake, limit possible can callers many as questions for to forward, one, get before please XX

Next caller please.

Operator

you. Thank

Louise Cantor. open. We And to will Chen line is of go your with the line

Louise Chen

taking thanks question Hi, for here. my

and treatment opportunity paradigms change BTK line this you. CLL/SLL think and line CAPTIVATE as reversible are So the with do could your curious what about just I'm then Thank first study? head-to-head for in how first potentially you studies

Sara Smith

Thanks, that. Louise. for We'll go Jake to

Jacob Van Naarden

Sure.

the for The think straightforward. namely So line I to agents, relative ibrutinib. patients first to opportunity outcomes opportunity existing in somewhat is improve is

meaningful who've so, prior same at of initial that against oncology, have the patients we look relapsed on other on pronounced that benefit head-to-head. when in same to And you -- those treatment that tend when areas agent same effect pathway have drugs one target line more compared pathway, drugs targeted

reasons it's clinical the variety of that one important to that's for ask question. this that risky trial very it's so of reasons. think we a many And a But

relapsed for first But drugs. line think the think will frankly, how of up. are end is patients questions those line especially I that think And on the home I regardless important to trials for ask. near-term agent natural, we who've again, first So patients persist, the in setting the trials

of limited BCL Your CDXX CLL referenced for We're two combinations field. limited important X trend relapse context embracing combinations, of therapy, an the time our the to of even CAPTIVATE with the study, therapy time setting one clearly or BTK, in that are BCL just studies. emerging trend the

do said, whether not to the having it's head-to-head. if all is important And a ultimately very we have to, test That question for the we're But we going to the attention it's an or follow. way so monotherapy setting, may patients. you be BTK think something that inhibitor of It first best -- know, in line think close trend to paying the we it's not been with real. right we're continuous

Sara Smith

Thanks, question. Louise for Jake. Thanks, the

caller, Next please.

Operator

your with the open. the line to Divan We will Securities, of line is go Vamil and Mizuho

Vamil Divan

question. much Thank Great. so for my you taking

So atopic of next baricitinib. just one question the for year. the a approval you And mentioned around revolves derm, key for attractions

opportunities maybe you data format, profile, and how drug a of And that uptake for just U.S it [indiscernible] competitive U.S. and stacks Thanks. also class, also [indiscernible] U.S maybe on have U.S, to system jack So broader a the wondering versus opportunity up. in given ex are their the think kind going safety I that think seriously, have about the concerns date the just to safety the the because lot outside

Sara Smith

Thanks, Ilya that Vamil. go for We'll question. to

Ilya Yuffa

the our obviously terms around see good and determinant advocacy to obviously improvement dermatitis. significant for profile data that around helping also and awaiting We is we What in bear got role see in dermatitis. And then And an a -- do whole, see see atopic under opportunity get dermatitis and as see success we one need from it's ability a opportunity and also has U.S. standpoint, it a and Taltz and to the [indiscernible] so atopic [indiscernible] work there where a commercial outside with sitting see for the both the do with [indiscernible] dermatology there. especially the dermatology data we both safety unmet as dermatitis, do profile utilize atopic we've in safety believe of overall our [indiscernible] of treated. to our standpoint, We We U.S. U.S significant with where the furthering also from [indiscernible] an approval our seen in be yes. we execution dermatology to in see we're We and make we Sure, atopic approval important an Europe significant area well.

to atopic and dermatitis [indiscernible]. see the So we both do opportunity [indiscernible] the adding commercial for

Sara Smith

Thanks, Ilya. Thanks, Vamil question. for your

Next caller please.

Operator

We of Bank will go to Meacham your is with Geoff the line of line open. America. And

Geoff Meacham

question. Hey, for guys. the lot Thanks a

or Dave, eventually add neurology expand areas to guess Dan, to portfolio? on into you as went the therapy deal the speak And I it? And need announced technology you. fitting gene from other you for what how So Prevail the the could into HemOnc. you maybe could today, into Thank such view guys

Sara Smith

Thanks, Geoff.

We go Dave for that will question. to

Dave Ricks

will we settings. drugs therapeutic the side, in other would be core become that modalities of start constantly landscape XXX Prevail of Dan But the technology the for could course, specific. comment to portability I important areas. our in maybe new strategy on Yes, to It developing wants scan on

a therapy. we emerging with surprise although a profile and shouldn't of sell like we a submissions turnover, of field, degeneration an data gene diseases did became in neuro are privileged It's We time, and about are, GVA our history the waiting there, for neuroscience. well gene drug for characterized, the the therapy and core well at we information that course, The very look Prevail. where was companies more compartment, Of they they're monogenic proven be etcetera. quite interested interest nature in to for like given exists area been support long we're a in And a given its target. lead comprehensive the us using That has keen approval. techniques

have can neuroscience, good modifying earlier And again. turnover. gene a with a number just we states then CNS no here first we our effort like the looks validated on last editing the in entry rather, this And course, to it a see go in quarter. we platform be therapy, I of year their transaction generation do So wouldn't reveals after to gene give expect within a our targets. neuron importantly, immune most also that said, have But on cell expertise of targets beyond disease [indiscernible] conditions. other important with maybe they of comment Lily highly privileged, as neurodegenerative makes our Dan Yes course, therapies point.

sense. makes So that's a lot of why

in progress [indiscernible] with here start Let's CNS.

place organ Of time, therapy different then is built we But air. will this for our be systems. across a course, gene over variety starting used diseases of different an and

Sara Smith

Dave for and question. Dan. Thanks Thanks, Geoff you

please? caller Next

Operator

to the Scala of We will go with line Steve Cowen.

open. line Your is

Steve Scala

just profit an be billion required if it's only you. but Thank seen take want And that midpoint range contribution. you Perhaps at $X.XX assuming in absence question, management in share not like If a one criticism. spend by the disclosure in you. to I'd antibodies it. a that and margin share. in that to to In release if that's move per This observation, policy make apply to have if how pancreatitis of to the XXXX look the sales the state about SURPASS-X. net flat per in of ballpark, I'm XXXX, am I should smart Thank Lily $X earnings to just a implies of is $X was you $X.XX billion, allow will we I opportunistically, understand is XX% the that COVID equals would

Sara Smith

to Thanks, that We'll question. go Steve. Josh for

Josh Smiley

somewhere and the what attributed at beginning we between the out if that I if $X.XX call, projecting you here, look of said COVID. think $X.XX and in ranges pull like got the you to Steve, we're we've

so out, XXXX at of XXXX without then and pull EPS COVID, COVID that without think we you look to midpoint midpoint see to mid growth. I if types double-digit, double-digit

at COVID, COVID and very versus business really again, to underlying that's what where for look us. growth, So how XX% that you I harbinger X clear look midpoint that but point good probably excluding parts or a of growth, gets next otherwise, you're we range and we're I growth, think the -- see in you to years top think X margin think there good it's maybe the expansion we will it line at EPS attributing double-digit which midpoint,

Sara Smith

thanks. Okay, if pancreatitis. to want to on comment observation And about Dan, you Steve's quickly

Dan Skovronsky

trial. But I something or disclose did Yes, can no now we not. we I you think have next idea not that's would just whether is tell that it

Steve Scala

you. Thank

Sara Smith

Thanks, questions. Dan, Josh. your Thanks, and Steve, for

Next caller please.

Operator

Bernstein We go is line Ronny to with will your of open. Gal and line

Ronny Gal

Good morning. a fast assumptions and very the year. factor into both in the those Congratulations Quick you acting the market in fine on how'd question guidelines? basal around around biosimilars XXXX,

Sara Smith

Mike Ronny. Mason for question. that to We'll go Thanks,

Mike Mason

of Thanks. able see access We market. the U.S They've Thanks the incremental XXXX. in to Ronny impact because payer an don't question. any get in been don't that, we for on for And biosimilars not see formularies. impact

Dan Skovronsky

of to $XX. which remind kicks usage January have program effect starting everyone just reinforcing D. will Maybe in, that just brand D the Cap to X Part in, jump Part in

the dramatically probably of to and a number that setting? affordability goes pretty improves large in incumbents for So, Americans

Sara Smith

thanks Thank Ronny question. the for you, Mike, and and Dave

please. caller Next

Operator

Risinger and your Morgan David to go is Stanley, the open. will We of line with line

David Risinger

Yes, thanks very much.

Josh, prospects is of net back XXXX? what on terms And just U.S expect And do expect net to what you in the you then in of for you in XXXX? you a could higher price could for question impact for go the comment little percentage ex-U.S? the So company, So level could price Josh. just total recap you be bit will and XXXX. then provide also, if my

meaning So the won't U.S of in the pressure in should changes have XXXX worse Thank changes XXXb price in color recurring would the because XXXX, we expect Any net you. helpful. worse that benefit would to you price percentage to beyond a be weaken, get XXXX. also be such

Sara Smith

go Thanks, Josh to Dave. We'll this. for

Josh Smiley

I done and with XXXX be Yes. Thanks, on. move was Dave. to just hoping

be to our guidance. about XXXX So specific first,

I we there think We're probably hit volume. a when added price compete we'd We'd by expect see going to function a look NRDL of compensated China NRDL, worldwide than products more declines. be in mentioned. single-digit see a and as on significant mid see price to basis, we we have highest other

probably Europe. mid as decline. normal modest pretty and So environment pricing in price single-digit meaning a function it'd Stable Japan, we see one. be declines stable the number of probably would there

bring many the In the get U.S., the together, outside that for in probably is of of U.S. us single think all I digits. mid we'll single-digit. mid our talking trend, about you down digits the low We XXXb in see that put So been do underlying single we've years sort benefit to as the the U.S., would reset,

the put still You think in in decline, U.S. together, you're all that of again, I a probably single-digit worldwide lower the on China, in basis, mid highest

range. probably single-digit I of think a mid from sort the trend then for are still 'XX perspective, same competitive to probably that XXXX, in again,

side a will the U.S. XXXX happen there's that legislative on and between lot now course, in administrative Of the

products. we in other terms we I for with see fundamentally think were the I structure may side. the dynamics see happy don't competitive our trends of XXXX, for what changing than anything on

David Risinger

you. Thank

Sara Smith

your Thank you, question. thanks Dave Josh and for

please. caller, Next

Operator

the open. Truist go We'll your line line is Gilbert of with Greg Security, to and

Greg Gilbert

can whether and and was Part worried Part for should some of the role seems given support weigh on industry hoping Dave, more more probably I you're could versus than get golden about meaningful worried a am. what aware a being that to Thanks. differences B opportunity done meaningful about other It I like regime. new be pretty at something centrist more you. Thank reform as industry your Board despite you Pharma, the Chair others D companies

Dave Ricks

Thanks for the Hey, question. Greg.

how industry and Lilly pocket, pay pump members Board the maintaining as you us backdrop way such costs. question, see majority Pharma it continues strong characterize for may of that and get. led environment base we improving at the think I to it. pandemic the is Both year of that's affordability successful while the think of I innovative to the a good that as the build pressure that patient on has responding the out And the

setup agree. Getting and two then between to tend matter the will for alignment depends the parties. I So tactically -- on the in that on companies. always between Senate particulars the The

to But yes, out to is moment, now I tell that ideas, is It's be happen. administrative to Americans do say, or that forward matter. what can that move that. legislative specifics affordability whether can pocket hard spirit for So maybe and can't to recognizing they or try to help of happen you the get the will to

Sara Smith

Thanks, for Dave. Greg question. Thanks, the

please. caller Next

Operator

the Raffat Umer open. Evercore line and will your go We of with is to line ISI,

Umer Raffat

much questions. Hi, my taking thanks for so

how regular? of was on there's for could the available the remind that versus much by wouldn't zero weight and XXs because customer on This there move [indiscernible] give loss. Jake I imbalance SURPASS-X, looks mid in X weight, well? billion And as maybe arms And performance mAb, in us high was versus placebo on like do Dan $X I to by one, our math. on doesn't And thank Placebo high could covid in AXc stockpiling it becoming possibility oral But on mattered us sense is billion have much. appetite you $X January. First a wonder, asked to Jake baseline XXs of adjusted much placebo an a imbalance hours if status a there you. a

Sara Smith

final we'll Okay. Josh for the question, question. Jake to question then Dan, second first for go and for the the And

Josh Smiley

Umer. Hi,

the really On that $X have they're we that it and the is of projecting, benefits be would Would no XXXX? stockpiling number. monoclonal the we're assume antibodies, billion products $X to range immediate encompassed billion for so those much what more in demand for there's

part that just So today, are really what what's come the to we next and place the agreements have of looking early in likely in purchase is what we're year. at

or long-term any not in So we're assuming piling of that stock regard. anything kind

Sara Smith

Thanks. Okay.

to question will We tirzepatide. go on Dan the for

Dan Skovronsky

Sure.

So were for for versus didn't They you're placebo We characteristics, drug groups. three asking or about the and the weight see well BMI of AXc group placebo and balanced drug. including the baseline imbalances. characteristics clinical versus demographics

Sara Smith

Thanks, Dan, and then Jake for LOXO-XXX.

Jacob Van Naarden

given differences correlated of about therapy was prior an question so and prior based prior on of in therapy don’t performance the is activity in I the we think varied combinations the status, the But activity extent answer. know of and likely effect with on context announced I the performance didn't Yes, as [Indiscernible] data. therapy. we see not perform,

through your not simply somewhat answer, of in read but a a have I data. a because don't the that's direct question, think I

Sara Smith

Jake, Umer and out queue, close Okay, we'll the to and back the questions. thanks That Dave thanks, exhausts Josh, your go to Dan, for and call.

Dave Ricks

Okay. participation in Thank Sara interested your you, call We in hosting Lilly you're today's today. for and Company. Eli appreciate and

safe our growth, again, another of follow questions and progress to with everyone. in the strategy As great have today's we address Thank committed IR you've heard your expansion holiday of Thanks XXXX. holiday up dialing meaningful a margin Please year are advancement great today, and we've Have made you. families. didn't a and team period you in if XXXX time innovation on call. a for based with in and

Operator

today. gentlemen, does participation using your for and Thank and teleconference that you for you ladies for Thank call and your conference conclude AT&T Executive service.

disconnect. now may You

Eli Lilly and (LLY) 15 Dec 202021 Q3 Earnings call transcript