Regeneron Pharmaceuticals (REGN) 2 Nov 232023 Q3 Earnings call transcript

Welcome to the Regeneron Pharmaceuticals Third Quarter 2023 Earnings Conference Call. My name is Shannon, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded.

I will now turn the call over to Ryan Crowe, Vice President, Investor Relations.

You may begin.

Shannon. you, Thank afternoon the good evening everyone to Good and around world. listening morning, good for Regeneron Thank our interest your you in XXXX conference third and earnings call. quarter to welcome available after the ends. transcript webcast of An call Investor archive shortly will and be website Relations on this our

Commercial; President Board Marion Joining on of Co-Chair, open Chief Vice and and Scientific Officer; Co-Founder, Q&A. Co-Founder, Executive Executive are Executive Vice Officer; Head Schleifer, Board call Dr. the our President Bob me Chief Leonard Dr. McCourt, President President Officer. call for Financial will Co-Chair, prepared today's Landry, and and George Yancopoulos, Chief we remarks, and After

like and Each to actual materially and projected business, financial may and are products is include, would on but subject guidance, -- collaborations, remind milestones, statements Regeneron made that from and limited revenue business financial statements remarks risks today's include those to that and diversification, anticipated development may forward-looking I not to statement. differ call statement related its related you in and about events and to forecast uncertainties could that competition. those forward-looking Regeneron. programs to results cause Such

whether any events statements, SEC the future does September forward-looking any a new these in of with to including United description which material this morning. Regeneron XX, complete be XX-Q update other filed for otherwise. found Form its more A was Securities and XXXX, not undertake result can ended period or Regeneron's obligation risks the with information, Commission, filings as and States Exchange the quarterly of

non-GAAP discussed those our in presentation, website. both and a GAAP that regarding measures corporate can GAAP accessed financial press which our today's of available and measures is our to measures be Information call. of in financial and release note be of will our reconciliation use on please addition, results In non-GAAP

me Len? turn Landry and Officer, any Bob our to questions. the Investor let President concludes, Leonard Relations answer call to Chief and further will Schleifer. With be call available that, over the our Executive Once team Dr.

to quarter marked by today's Thanks, pipeline. top Regeneron growth innovative our drove R&D and the joining across double-digit delivered thanks line call. progress Ryan, everyone and continued across which notable company, execution another strong

impact XX% primarily by prior and global XX%, by revenues compared and Sanofi increased R&D. basis XX% global net increased Dupixent diluted net product Non-GAAP billion, to -- sales sales. XX%, by revenues $X.X the share income including all reflecting were by growth approved a year on which reported share strong IP up driven from Total per acquired Libtayo net product unfavorable $X.XX quarter, X%, grew across an respectively. collaboration indications.

George, progress who Today, to developments, for launch commercial of continue execution I and results HD, over the and then quarter. will across latest hand thinking commentary will our our will discuss the the and the our call on make provide additional capital we EYLEA pipeline, I allocation. financial briefly to Bob, on our Marion pipeline,

the August final approval, compares to with launches to HD, $XX category. million following of in product which net and quarter, the off Starting which of recorded a X disease retinal favorably shortly We is start. launched late in FDA sales in great weeks the EYLEA recent

reorders by driven before multiple end were initial demand by the of with distributors strong the revenues quarter. Importantly,

as utilization were positive spectrum wet trial the HD shortly EYLEA clinical macular launch, the Early of to across come build to for accumulate. enabling product. the macular diabetic patients, samples and addition, has prescribers patients momentum degeneration In real-world age-related experiences and HD and made available continues from edema after EYLEA

positioning by EYLEA dose HD, in diseases. retinal standard have will a of anti-VEGF made work significant as We progress we approved FDA, highest care access therapy establishing continue to and new also these reimbursement, the and the on

in oncology, have granted priority we progress Within and data -- accepted our hematology platform, the FDA CDX XX CDXXxCDX the our bispecific assigned. a PDUFA review, Moving on recent are was certain for the by in to advancing lymphomas, bispecific which made odronextamab, BLA pipeline. with our March

submit ], myeloma, on with month our year. to We preparing for BLA track for a launches both now commercial multiple limvoseltimab support accelerated bispecific [ approvals, to BCMAxCDX next pivotal for X underway potential for we also are remain programs trials next

with Last loss. week, potential for profound a breakthrough reported we hearing patients congenital

enrolled [ designed weeks ], the compared [ selective an autoferulin of treatment loss The CORD I/II first hearing in therapy durable BB-ODO hearing after adenovirus-associated hearing profound experienced gene, viral congenital to physiological ] baseline. caused investigational X improvement mutations in individuals to clinical trial the cell patient provide Phase with gene by to

looking further validate forward of to follow-up approach. this as patients patient are to enrollment this with additional continued as We therapy gene well

autoferulin an are deficiency ] in we causes more that can profound hopeful gene expand is common we approach [ ultra-rare While our the to genetic hearing loss. gene condition, therapy year to of

Finally, regarding capital allocation.

the flows, the and of cash balance to strength future While actions sheet value. believe shareholder to internal additional we given investment, we we prioritize our anticipated take to drive continue have flexibility R&D

continue our repurchase to and R&D emerging innovative core Beyond science actively platforms strengths. program, we pursue ongoing our share that complement

technologies muscular the we announced to jointly last vivo our with in Intellia's programs the liver Decibel acquisition, month combining diseases. Intellia to of an antibody and viral proprietary neurological collaboration targeted with addition explore CRISPR for vector expanded In research outside delivery platform

deploy have generating to a with the delivering always with returns, of about to breakthroughs strategically focus patients to will goal carefully to on think long-term and we our value managed shareholders. Regeneron capital, how and continue We

we pipeline ways at important closing, HD we look allocate strong and progressing a In to continue efficiently capital. third our delivering to quarter, EYLEA the innovations, had launch is is well,

turn to call me over With George. the that, let

At by presented our from XX-week HD patients the start XX- study majority data update to every XX-week and with weeks. ] XX-week vision for vast the Thanks, EYLEA Meeting month, the patients HD. intervals results EU XX% at PULSAR like sustain AMD, Len. dosing EYLEA through for recent demonstrated X-year entire [ the to to assigned the I'd maintain anatomic end to in improvements that were least X-year all of to which of period. we continue of wet X-year Retina XX% last intervals period, with the least at randomized dosing and the dosing EYLEA XX able every HD

XX% the every XX% at dosing week patients for to XX% met criteria intervals, at many second longer at Similarly, equals. who to least least randomized baseline years dosing for every were of [indiscernible] extension for criteria patients with year, able XX-week to assigned least XX-week at the XX-week intervals, dosing including X dosing even eligible maintain meeting at were the to XX% during XX-week with dosing XX. Moreover, through

remain a and vision while intervals their AMD the over the improvements become potential new and EYLEA advancement such the profile patients HD consistent believe in these for standard of give these DME with to is care EYLEA HD safety X years retinal maintaining The diseases. physicians. sustaining We and for remarkable wet EYLEA, of results both anatomic dosing extended that

Moving and to X our our success secondary in BOREAS immunology uncontrolled Based Dupixent in and study endpoints all with biologic pivotal evidence the patients for a COPD, III On in and inflammation inflammation. positive primary of analysis a an X The interim in first met study independent type a COPD Phase addition sBLA pipeline. will year. study notice previously to on a III the the study monitoring of conduct replicate Phase study, would later enable the positive data committee the of submission. FDA, analysis from in notice recent interim results the BOREAS this from feedback an unprecedented

distinct Dupixent results to itepekimab III Itepekimab, submissions and of studies. that of anti-IL-XX these mechanisms AERIFY-X forward of remain in our studies COPD the the both reducing their regulatory inflammation Phase and potential we track in COPD XXXX, treatment disease and X for the different contribute on could to antibody, and paradigm for progression, leveraging actions readout by look types transform

Moving the ] cutaneous encouraging carcinoma X setting We remain treatment currently to which squamous data target annual II studies. of Libtayo. provide enrolling survival of We the our event-free our fianlimab, the XX% CSCC, believe trial antibody, cell majority, on we combination year. of metastatic patients [ or ESMO first-line At the melanoma. oncology earlier-stage combined for and presented meeting, study this Libtayo vast based in resectable for and for our in neoadjuvant from combination demonstrated Phase on this at LAG-X a significant are may Libtayo with advance patients pivotal with

the melanoma in conducting recurrence. in to malignancies. These It disease risk. of of since patients noteworthy body also We're results explore the perioperative setting the a and initiate at in had patients XX% is of combination the Libtayo To this who checkpoint and and we study adjuvant that heightened of adjuvant utility are of combination other other a CSCC experienced add this, Libtayo growing Libtayo the [ for ] none may have and also melanoma, as CSCC to earlier in stages well. have of of response, pathological further complete evaluating plan a fianlimab evidence inhibitors trial

to bispecifics. On

First in hematology oncology.

pleased data that altranextimab regulatory [indiscernible] lymphoma. Based well DLBCL. current are bispecific, of the review a the robust recently combination we investigating from was Phase authorities study, and our relapsed/refractory as Olympia accepted [ X We [ the by have in lines large follicular CDXXxCDX [indiscernible] Phase in monotherapy III initiated European follicular and standards and as earlier care with in as of both on FDA for diffuse bone pivotal ], II ] altranextimab development program, lymphoma

presentations from LX to this We the are forward data later looking pivotal year.

of is regulatory application will olimboseltimab our offer myeloma The enrolling for plasma relapsed/refractory antibody [ bispecific ] Phase cell standard multiple in confirmatory other study year. the potentially enrolling olimboseltimab our [ soon. be of to compared ] [indiscernible] may [ efficacy also for This end lines regimen III track We're diseases and to care on the of and myeloma and ] MMX convenience. submit a BCMAxCDX Linker by studies monotherapy best-in-class multiple earlier

] combination Finally, in ] ongoing costimulatory a bispecific co-stimulatory year. I our also Phase [ CDXXxCDXX next we're track [ initiate to of study on study corresponding the a of bispecific, with in limvoseltimab addition altranextimab to

other on early were the patients combination as responses to ESMO, of of on upon with advanced these in and initial addition multiple investigated activity promising with for in evidence of for in which MUXXCDX we ovarian with tumors, combination clinical progression bispecifics Next, data observed combination durable In the Libtayo are initial ubamatamab bispecific Libtayo responses monotherapy our leading cancer. monotherapy Libtayo turnaround shared At solid modalities. ubamatamab, encouraging well being with Libtayo. data, after as with

Phase also randomized study doses evaluate order in potential tested II with with activity of the dosing combination optimize A Libtayo lower the monotherapy to in of ubamatamab, X Libtayo. ongoing evaluate is active expansion and to added dose

rare levels we're in of are that MUCXX. addition, to ubamatamab multiple known cancers exploring express In high

exploring trials in clinical we early of antibodies combination In costimulatory multiple of settings in different CDXX bispecifics solid bispecifics. with a our corresponding terms in tumors, are for Libtayo costimulatory with variety CDX bispecific currently tumor

CDXX by prostate have ] [indiscernible] CDXX explore cancer, to opportunity PSMAxCDXX expanded adding while this, soon window patients. in bispecific PSMA for our of will to enrollment with of development PSMA toxicity. observed which cohort, order in antitumor In by [ a co-stimulatory monotherapy in of low solipimab the continuing and in identifying are minimizing initiate the have We maintaining serious focusing remarkable and advanced dose we cohorts the an of certain option investigators the treatment activity we'll

combining activity based initiate costims may without with Moreover, trial data antitumor bispecifics severe on yield CDXX preclinical adverse we immune-mediated appropriate a to events. with since, plan CDX PSMA/CDX PSMA/CDXX

an in our year, may the We towards clinic PSMA we prostate additional bispecific costimulatory also to with CDX which progress hope bispecific. combine next also the specific

planning in Libtayo In on with the the terms costim year. of MUCXXxCDXX ovarian are presenting cancer, initial combination data our of by we end in

costim Regarding are dose XXXX. we by our combination in in with updated on planning CDXX data presenting Libtayo, EGFR escalation

cohorts We or expansion tumor-specific without metastasis, enrollment X the mutant soon as commence lung with in including will cancer non-small study, cell well colorectal as liver cancer. EGFR across

the in of Intellia a Now with address our reach editing to collaboration proprietary aim recently inability technology, of medicines. deliver the antibody Regeneron's neurological liver. to genetic is to expansion research in diseases. goal target medicine, We genetic genetic muscle beyond expanding bottleneck the of to payload and include and announced current delivery vivo The collaboration to gene of expanded the this

AAV targets. will X approach proprietary validated preclinically initially Our nonliver in vivo antibody-directed test

first announced to The a and trial a investigational start the Intellia clinical year-end editing XXXX. development expected gene to States. cardiomyopathy, clearance FDA United by in is we in of CRISPR-based of time amyloidosis NTLA-XXXX for therapy Additionally, clear the vivo is the pivotal late-stage Phase III to initiate enter in treatment trial ATTR with

months and updated after the achieved measured disease [ presented disease. in APP Moving onset XX to in to our showed data Alzheimer's Updated Alnylam reduction recently amyloid alpha Alnylam early data angiopathy. collaboration. implicated in administration, ] as that up CSF interim sustained reduction cerebral doses single beta of in of ALN-APP peptides as robust APP Alzheimer's amyloigenic and ALN-APP well

patient proceeding also the sclerosis to has a neurodegenerative announced first the additional redosed We amyotrophic with for portion that ALN-APP has multi-dose outside lateral Alnylam currently the plan Alnylam of clinical States. next programs been and study for diseases, year. initiate of in including United

brainstem improvements as audiometry. results through trial. an year highlight X for we've ] week, the Finally, in therapy, our X received which in genetic of to to who I autoferulin company intraocular auditory in as this like a Therapeutics, responses from recently year week program ] hearing [ to, [ child Decibel including ] years that DB the DB over acquired. would gene with behavioral A clinical developed collaboration first preliminary Regeneron's well experienced last compared injection both first loss, [ Odo few hearing baseline, in Last tests Odo we announced we

We for [ the evaluation hearing as forms ] of are related more in which loss. include as genetic of clinical ongoing ultra-rare this well loss other approach common the planned programs, continuing hearing forward innovative to looking autoferulin trial in

year and to and R&D continues forward this looking and late early-stage in XXXX. Regeneron's to and opportunities, In the remainder grow to progress deliver are we ahead engine looking conclusion, differentiated of

over that, turn Marion. it to With I will

details Thank for our quarter, performance EYLEA including the ongoing from commercial share early brands. you, as results as third well George. very in-line our delighted of HD I'm to encouraging signals in

extremely $X.XX U.S. use and types broad fentanyl AMD were EYLEA the HD patient sales net HD U.S. prior of disease. And total sales excited its were billion indicators in late diabetic rapidly Starting was franchise, We net for to the with $XX quarter our approval. wet been a high million. in have early Early EYLEA in positive. achieved into enthusiasm quarter launch following August launch. the launch to interest has very that Physician And anti-VEGF Regeneron total in across range eye translated for

are It EYLEA and that physicians is patients. noteworthy switch recalcitrant in HD prescribing naive

patients obtain of reports are drying to already been are products. returning. that whose unable they these case were with anecdotal hearing recalcitrant now other able We from physicians patients have achieve Many to

market our experienced team early and rapidly To launch highly accelerate this momentum, is advancing access. reimbursement

and This plans. We have from paid both recently of coverage Medicare includes many large published claims payers EYLEA confirmed and jurisdictions XXX% have Medicare for Advantage HD. policies commercial

is outpacing of While significantly EYLEA the early, speed HD coverage launches. recent competitive

to ] drive by continue to have J-code we which XXXX, anticipate uptake. X, addition, permit on In a track April we be additional [ will

in coupled by These early expected unsurpassed well initial and reimbursement of with with and HD's EYLEA broadly and become belief HD EYLEA confidence successes its community. leadership. will and category These bode across in our standard care rapidly prescriber retina positive the with physician safety of the indications. durability and drive HD experiences new continued EYLEA are clinical trials, approved is record, EYLEA's demonstrated safety efficacy our that to results the being substantiate future prescribers shared more team for

in while providing updates. market. look XX% are for category injections days, with future and since with strong EYLEA, the pleased and sustained early leadership. EYLEA franchise competitive remains an continues and million retinal share forward key certain worldwide summary, In in and profile, safety to increasingly quarter to retina launch, leader in EYLEA over we With is both our the a launch introduced our category. progress inflammation products EYLEA the HD is differentiator XX retinal anti-VEGF poised demonstrate With events the new intraocular given consistent for formidable with a vasculitis still

billion. indications demonstrates and quarter as differentiation sales well potential. $X.X billion, clinical Dupixent's across growth XX% grew Next, all impressive net performance U.S. sales its to to net grew XX% year-over-year and approved continued $X.X as Dupixent. third safety This Global to

efficacy, of growth than third are atopic largest see safety alone, than and there in quarter, X In have the as XX% patients as the than Dupixent combination of In patients months. more on to ease all from post XXX,XXX young now new more U.S. more years great taking XX,XXX X age groups, Physicians dermatitis, across worldwide. we the continue indication, and launch. are use including confidence Dupixent's Dupixent

we growth adherence for treatment once is remarkable as the new patients choice begin to only disease, moderate with see opportunity. the Dupixent clear patients Not of significant being with therapy, severe also

In exacerbations sustained goal based the its and differentiated in we medicines medicine to function, for #X Dupixent patient other use. our category asthma. and new of lead prescribed on the reduced asthma, the is reduced being approaching In effect are lung all rapid from quickly on and corticosteroid continues Dupixent U.S. prescriptions,

with been and robust rapidly ], ] also is demand already FDA XX,XXX and nodularis nodularis Together [ Dupixent's partner, Since contributing of patients approval. year to prigo approval, initiated Regeneron in with becoming esophagitis where our new for the are to advance launches Sanofi, growth. which of continues standard a esophagitis care recent eosinophilic progis meaningfully [ approximately have is within Dupixent eosinophilic

to readouts We Dupixent also the more anticipated chronic Phase regulatory and pediatric on multiple well COPD, of offering even with look patients as esophagitis forward near-term to in urticaria spontaneous as data eosinophilic III approvals [indiscernible]. future

In summary, and diseases X growth, look to type indications, forward to Dupixent with of demographics transformational its be a benefits across more seeing and even to geographies. our key inflammatory patients continues driver we extending

to finally, Libtayo. And

expand growth recent in following lung quarter coupled with sales million, cancer. in $XXX was in countries to regulatory by approvals. net XX% to additional combination with on use net non-melanoma basis year-over-year chemotherapy working driven constant currency We're up and monotherapy access sales Third our $XXX and increased U.S. to skin global both a XX% million. grew utilization Global indications settings many

see choosing treating growing of patients. their when Libtayo to prescribers continue We number a

value opportunity early and indicators EYLEA deliver patients continue growth continues Libtayo. from We're third encouraged for performance compelling the Regeneron's with conclusion, our the and including launch from sustained and growth. in-line to shareholders brands, deliver favorable HD EYLEA, Dupixent for In performance in by quarter to and

Now call Bob. I'll turn the over to

comments Regeneron's basis, noted. otherwise Thanks, on results Marion. non-GAAP on financial be unless My today outlook a will and

well to quarter, business bottom growth. Regeneron drive in line across the performed third continuing the strong top with execution and

year-over-year growth collaboration from Dupixent, quarter for $X.X revenues within coupled total growth primarily sales XX% billion, well increased Libtayo. continued improving to Third Sanofi driven by as as XXXX with margins the

growth X% incurred which of X per $XXX net percentage included charge R&D on diluted income income to grew billion. of Third a quarter This share decreased quarter $X.X approximately third IP million the acquired points. net in by $XX.XX XXXX,

Moving with to Bayer. revenue collaboration starting and

sales a share constant third ex-U.S. million, our Bayer sales-based XXXX the profits versus basis collaboration Total were million year, on million currency of which net prior the $X.X EYLEA was up quarter was revenue the milestone. net Third quarter, U.S. which EYLEA million, versus revenue to X% the collaboration $XXX outside $XXX related product the year. of Sanofi up final XX% in billion $XX Total prior $XXX included

increase of margins. profits volume continued Dupixent's was quarter the by and Dupixent XX% share of driven commercialization Our an and $XXX growth of versus the from million, third of KEVZARA XXXX, improving

expected As phase-in third due Sanofi, last reimbursements expect to of revenues, from a $XX Sanofi of for the by component commercial this In process. million. lower fourth supplies approximately of the we guided quarter, sequentially ongoing of manufacturing supplies a be primarily we sequentially, a from with quarter trend quarter, higher-yielding the of declined manufacturing collaboration continuation manufacturing to commercial reimbursements new

next-gen $XX from as reimbursements Other per prior development for the COVID quarter $XXX of XXXX. the antibody announced of XXXX, of million up versus August inclusive million revenues agreement the in and BARDA were year XX% of in our third ongoing

our Moving now operating expenses. to

growth count advancing investment our expense representing increased by our primarily as costs pipeline, pipeline. year-over-year head expanding funding continued well was related activity. driven R&D as higher late-stage clinical R&D manufacturing $XXX in XXXX and XX% quarter to million, Third grew in

higher organization. related quarter, year to million SG&A to $XXX the not-for-profit in third grew prior from assistance the and in costs head XX% contributions an independent higher count reflecting patient

both payment the program the early we recorded impacted by R&D related Phase our approximately milestone IP million, ALN-APP onset acquired In collaborator, GAAP third in quarter, development to I reflecting EPS the a of disease. and $XXX to Alnylam, Alzheimer's This non-GAAP of $X.XX.

process sales prior offset year, volumes up lowest was million, the expected quarter costs. is manufacturing associated versus continue by collaboration the as lower COCM driven quarter to partially we costs XX% Third year Dupixent. manufacturing quarter higher-yielding products, COCM the the of Dupixent by with for to transition manufacturing from to $XXX Fourth be higher

Regeneron flow Now sheet. quarter to balance and billion with ended the cash free approximately less and marketable the approximately the cash generated cash securities Through debt third billion. $X flow XXXX, in and of third quarter of $XX

capital respectively, and our authorized XXXX, with on back the allocation deliver share months $X.X of in under first third billion and to remaining $X.X $XXX shares quarter X billion continue our the program. of buying priorities, We our existing repurchase million

quarter, approximately completed third we the genetics Therapeutics for to Decibel acquisition the in and portfolio. of strengthen also million, announced Additionally, our $XXX medicine

to to evaluate long-term opportunities our of As and Len the position shareholder goal our mentioned, we upon competencies build value. utilize strong continue delivering with core financial

A to ranges year and XXXX Finally, expenditures. guidance our our margins, available we've made year R&D, guidance in morning. issued earlier full outlook, full financial release changes latest complete some COCM latest year-to-date press results our of is gross this updating the minor our guidance capital our XXXX for summary and on based SG&A,

the preliminary provide As we to some on the commentary end XXXX. outlook for XXXX, approach I'd like of

the billion. which XXXX, collaboration this years, collaboration, profitability Sanofi expect paydown in of will was is development next balance, we continue Once repaid to the the profits. $X.X of We expect from fully as in accelerate meaningful our approximately share continued balance Sanofi few September step-up in the antibody XX, which improvements of a

we in PRALULENT, negatively competitive significant sales impact pressures for Separately, and category U.S. expect that XXXX.

operating our our expenses. continue capital internal growing allocation pipeline in R&D priorities, Consistent with we long-term to drive invest growth. Moving to our to

support growth to R&D manufacturing R&D such Libtayo costs XXXX the of expansion genetic our fianlimab lines to in including from onc As our expanding broaden, driven by higher our clinical in advancing confirmatory combination, collaboration of investment expand. studies, earlier organization. important and you and as that our hem medicines, continued programs will as be therapy, continues as well strategically in just continues late-stage pipeline heard while to infrastructure our George,

the mind, compared we in to R&D in mid-teens anticipated XXXX XXXX spend. be expect this growth our year-on-year to in With

EYLEA additional support We our and and G&A also hem international commercial launch the launches business investments to our in expansion. our HD, of expect make onc functions planned to

In position the to investments that, With financial conclusion, results, strong growth to deliver this make will allows I back Regeneron continues robust pass call to Ryan. and time. now strategic to us drive our over

Thank you, This Bob. prepared concludes our remarks.

will now as we for we ensure We answer to are open Q&A. the to before able each the go as To we questions call one caller from moving to address many question possible, that will question? can first please next. the Shannon,

with [Operator from Our comes question Seigerman first Capital the line Instructions] Evan of BMO Markets.

all on progress. the Congrats

think have even could So capital well could marketable shareholders? of Regeneron higher you Bob, you spend money I over talk high. balance returns for drive cash $XX Maybe your you on how are billion know rates interest sheet. allocation. But that about and how you securities to about

that Yes. tasked we've Thanks, our an with of Evan. issue I investors, mean, solve. I is know you been this having to certainly dealt certainly many and

obviously, Now a rates lot are interest higher.

I to is better regards certainly So XXXX that the possible progress kind obviously, and foremost, first and of that plethora we're mean to we're through extent knitting what make returning capital obviously, the that, of here funded XXXX. stick than that. sure on allocations. fully that we kind pipeline George But much our to went on going making. with Again, of, to a days we're just is our the of

intro. that not as on Certainly, of with there continue you shape greatest market a heard to Len's look know. mean the in And out is we biotech the to opportunities. acquisitions, the regards space I you at is then lot with

opportunities into out doesn't we're just may of It give going an result. So again, we But means, say be heard there. there we before. not as of not you've mean -- something that to that we franchises, kind may us it kind me optimal have think are push like because the that

regards need to sure the with and that. it's So with George fit the to right that make team we

continue we'll to So that. do

with very our to And through of catalysts how at months. that. have. you've seen continues and think We undervalued buying $X.X price very that kind that approach all good be progress we're We're We've in regards a of pipeline that scientific the we're which given X back. done we repurchases, the that our to billion stock do share on

So we're button to that going going continue to forward. push

right again, Len we're the are the our Decibel, we'll forward. into that are again, of of one nice makes going the looking there. at were albeit a And franchise knitting. but lot and stick And alluded necessary to of with So kind fit, CheckMate as kind out But were to, saw of to you that we fits opportunities move those kind those then business. smaller, again, if

Bansal the from comes question next Fargo. Wells line Our Mohit of with

eosinophil are Congrats on the way you other question And about Could are behind Dupixent. basis rationale counts doing marker enriching you bit ulcerative there? a progress. My any talk is the this regarding of trial you or colitis with that? the trial little in any on the

Yes.

what in of of that and the really the is treating have Dupixent in so-called in diseases realized that the sort that with hinted that all in disorder, is cases more body. a are and we all at, in most reflect in forth you type some cases systemic it the inflammation, location. diseases we upregulation as one gut, . are cases, actually So in of X And patients the some so cases over many skin, lungs, some manifests than in in interrelated

including there in are patients be with gut. so we may inflammation X as disease we're mentioned, who marked And believe subset of that in now, type after, ulcerative their that a you going every in colitis,

patients. utilizing select might indicating biomarkers say, these -- you out as are, that We

whether disorder. driving all And other so ulcerative systemic we're colitis this patients subset going the related X see inflammation of manifestations a to of that's are type driven by this

Chris of from line Raymond the comes question Piper next Our with Sandler.

Yes.

into on Just maybe COPD.

alpha the the about you interim this, by on But taking this to guys the were It step the you sense think to alpha given take look? look notice, on you've decided last hit you on talked just risk interim I here. reward hit. time like taking an a that looks you we doing talking are of us can give

in exacerbations, reduction But looking you have color it risk the any you're to similarly. release a And just is of about it's this amount of the on got decent give can assume of of mean XX% thinking press I at here you've us if the I notice be a if year? end tracking would how that going And the seem decision. you BOREAS reward room this, more if -- that result with

into to work an possible for get appears. is when Yes. of sparing this appropriate We'll typical to you do We're and manner information do interim how closely not going An to alpha on as niceties details the with analysis. most it in approach efficient the statistical how get this. on the the Sanofi what's

next question of line comes from of UBS. Our Colin the Bristow

the been Not an and was of your And increasing [indiscernible] surprisingly, wondering if we've assets. obesity questions antagonist. you've I the got just could on strategy maybe the time talk here, on and getting lines, of enthusiasm Congrats of level some your GRP to XX, the quarter. you frame number out

that Just us presence would there think force you enthusiasm. helpful. blocker I and Is have you tell a Maybe going could pretty provocative and lever -- shared major plan the A ADA in to just some you're data this down some to your color the the road? on be [indiscernible] something at full myostatin blocker. go

Yes.

approaches As of leptin is the I our such Genetics Regeneron the well One to is antibody. you first as of targets agonistic been we've taking obesity. receptor unique approaches new identified as very Center, either ] been excited like about, the target very [ guess, target which for exciting came obesity, collection that GPR X that as said, discover, we're our we've that XX, in a from new genetically our our

weight their now, This thing exactly and is average, off. muscle. these public which can we're problem pounds potential right will muscle meaning those be moving that over as field of But programs that if understanding get recognizing X agonists, fat, muscle to type on and dominated if the of pounds, this weight off in of But the is obesity. drugs GLP-X what back. means never XX as the is you XX% said, potentially by patients you dilemma. field, in lose is the go large problems create That forward will that patients also the due of about health time, especially very loss one can, weight regain Most loss, a approximately, is with doing increasing

loss. do importantly, setting we or that and weight hope, very think, muscle muscle as we out, the preservation in in of agents. sure most and field are loss, even of to We've lot greater can developed we most grow So even the existing agents resulting weight with increasing area, whether And muscle this. talking maybe clinical certainly loss, we see weight growth of their preservation the field these maintain But quality have a growth agents so in in combination ability some the the hopefully, how do very of, in terms better. been, And about and the our weight to I pointed in the to patients candidates we the forth, in shortly. that will be also of this perhaps study making trials muscle muscle exciting you muscle of loss active some considering have

line Our Tyler the Van Buren of next of Cowen. comes from question TD

that great samples Congrats you course. about EYLEA are early It's sales? from on sending are [ are mentioned And But switch being we Vobismo out patients additional guys demand quarterly And seeing and extent what specifically? tremendous you the to as beyond assessing of sales, you think ] treated. results. see to switches HD naive the

Thanks, Tyler.

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switches, the In days. terms of early it's

products We are more are would from in seeing well. you from switches are also category. And from switches But patients to leaders, category have we're the frisomab the EYLEA, consider of as Avastin as course, and there hearing been expect, also so the and other encouraging. reports ], quite [ hearing switches early we potential we're

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of Flynn of line Our comes Morgan the next question Stanley. Terence from

for litigation the us. Mylan? update Terence [ the provide you Max on of ] Skor or A one with on an Flynn. from EYLEA is biosimilar Could relative implications quick timing This

Yes.

ability are trial Virginia, come. control. It's So will months, where things soon come one we And we a waiting from as several and judge. could not. it our been in had really comes, soon to Out predict so as control. beyond trial, those and of a the our for It's it it decision it's of bench or West a

question Gould next the Our with is Carter Barclays. from of line

of a dynamics all Maybe color Can on EYLEA. though follow-up touch your edit broader of EYLEA, much sort didn't for line some what is for with step tracking how seeing standard relative how that's sort as you you the were on with -- progress. any for Is of or commercial evolved? in high-dose tracking maybe has the on the dose on Congrats one expectations? Marion. that Thanks to you commentary the thing language

Sure.

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jurisdictions over claims. The HD which business Advantage, demonstrated HD and When is a EYLEA a differentiation making far, good the XXX% to plans, XX%, we're you about go are fee-for-service with seeing we're consistently is as category of category. roughly we're paid there So seeing And positioned what other and consistently Medicare there. management. and now EYLEA other edit in which that we EYLEA know, is that and commercial, with positioned step don't seeing payers, is have EYLEA good and Medicare being with we that news that being are is have coverage or brands see progress utilization We brands. so about XX% of anti-VEGF

Truist of Our Robyn from with line next comes Securities. question Karnauskas the

particular I the controlled big Many not how antihistamines Question on with changing a in for what [ the looking they view is CRL. it's there Is approval? Is CSU. they FDA opportunity. a there? know sufficient? a they Study disconnect? and your patients for? What's Anything are you think thoughts well ] bar have you Are C -- for

to call ongoing And FDA to wanted their see that the Study study. Well, P the of indicated Yes. it's you actually as it, the we all they various direction. indicators of for statistical very just know, make as a what certainly had one had we that are had in a positive the hurdle, results predetermined our right purposes its second meeting but but study, C, X.XXX, We statistical missed decision. going

in A, failed population data of in study will remember, so Study same we look get upon patients therapies. -- among as that what the very these is we're consider that And and is positive that who recalcitrant hoping it. But we're the C the FDA was our study. other And very that study same the favorably that initial study, consistent study, XOLAIR the in first in population if is which very second Study positive hoping the have

Our with line Goldman Sachs. next question Richter the Salveen comes from of

coming emerging but still to we've the proof competitive additional and we're positioning talk ASH your you're and can and you that at just combination how us in of looking to thinking data cancer to regard here With with it the optimization so the far, to about seen portfolio, concept context out about of dynamics? data as look we Libtayo, required targets

Yes.

combination very large have We about. we're that of a excited very opportunities collection

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it cancers in whole to series perioperative such to setting as really both adjuvant such could related even where announced be be from next as perhaps a we hope And it up provide earlier an the principle. melanoma melanoma door patients. first-line as trial of opens as now, within might the opportunities, results melanoma will we that we the we the well in If other advance setting, settings, to works stage that moving and we're pivotal the which a for year, but that settings, confirm of proof this other in trial, -- in with remarkable able this

checkpoint the combination that's nearest So approach. Libtayo term

either Libtayo our As opportunities agents also are for having best-in-class you in each myeloma the combination know, or our so agent agents, it's type forth that with have, we we of is with And once follicular CDXX there in, potential important on. again validated activity, very as our shown so for bispecifics, for the and whether bispecific our individual example, so with thing many or lymphoma that space, individual of and the our have other. exciting, now

events. be having to on hard immunotherapy the benefit think, We're the preclinical our working dramatically efficacy immune we see one, early autoimmune don't based that increases about we in We've bispecifics our where these with costims with of it lead in may mechanisms without adverse bispecifics. countered in increase these that that extent associated very that CDX excited we're data, reactions. Libtayo. the to released trick dramatic we stages But is that potential that, combining type patients. the and that the with It may by combination increased one our concerns also at data events hard adverse seeing costim about see with in we're incredible immune-mediated is on But

very So near in summary, term. our are checkpoint combinations

Our in future. near to -- the the efficacy exciting we're the for will bispecifics try best beginning hopefully that validated tune patients. for And present be and by and the are trying FDA have considered are order combinations demonstrate profile agents been relatively single approval to in being opportunity, to to safety

Our from Brian the next RBC Markets. Capital line Abrahams of question comes with

far. launch so good on Congrats the

a could this in mentioned impact as stabilize? elaborate that this, I Any of well? EYLEA if might EYLEA. bit when you affect wondering was might think release You this press on the extent little some high-dose you on price more

Brian. Sure,

reflect And if in some comment would a increasingly there, of in been on pressure there's an the on discounting I of that market, the really category, EYLEA. that look of brand. you brand the also course, price a that, that in at I'd competitive taken rebating and modest it's So history has course, XX never increase. years

of and gain the watching sure in physicians in EYLEA of appropriate confidence much making EYLEA on thoughtful very as of they that we reported days, continue HD, progress we're pricing. be But uptake initiate as marketplace in patients. some very HD early strong responsible reimbursement And measures will very certainly, making to to, taking and I terms

the Our next of Suneja with Yatin comes Guggenheim. question from line

OXXX franchise? Maybe [ Question longer-acting efforts terms your example, of management For cycle on views of about can Dupixent in on you on perhaps Dupixent. mechanism? ] the a Could of if version you maybe your share talk or life the Dupixent? newer

in made Yes. conditions, systemic in type of immune Dupixent not pathway The of like the largely that digital that some of X fecal so-called parasites, world. and comments back the type is I by parts things X look to now really to a the allergic fight the most which really was one literature Maybe so-called problem characterized and system, active are getting evolved developed if science the an addresses, which you which are collection all issue increase inflammatory of at of the before. this inflammation, or

be do of role. no world eosinophilic esophagitis. is doing, be unleashed The abnormally system becomes atopic It part immune almost essentially the like serves in it or in it the quiescent. attacking shouldn't or to fighting or dermatitis the entirely This modern skin things gut problem that the should allergens

Dupixent world, that incredible the profile unleashed parts And in only it shutting all shutting it it's of that What that and data tiger demonstrate is down that in back vestigial is becomes efficacy but Because pathway the belongs. body. what's cage attacks this it is has and useless not this, why angry this uniquely puts modern now the it incredible effect, controls, down where a that does safety. should the be of different the

features system's doesn't are like, the approaches, its actual including, immune the the example, We so things that OXXX world, of modern ] are all approach across fundamental that diseases that's and current infections of with forth. safety in competition to for and unique remarkable its viral lot these this ongoing addressing believe a incredible important of in spectrum in do Because give share different [ function any for cancer that Dupixent of useful broad pathways these example, immune other profile. efficacy so fighting forth, the

with over perfect profile, what the a we this drug infections help same disease, of that the which nodes, appropriately of down helps So effects causes digital actually make blocks and in the it the if in forth. should It to patients Dupixent be ability understand so regards and the body. it, Dupixent untoward without so and this it a gut all the shuts condition. the this if manifesting really the has can in disease can to the for it and and explain down body all forth, skin pathway, could unique and really in it be very out fight patients, control physicians uniquely lungs, and pathway vestigial shuts whether gets in it

under actually of some at unbelievably you clinical if the many, of control we to the the do Because reduced allowing published, function. immune not see look what fact, back our in putting system bad in In setting you you're studies and rest of data infections its most is Dupixent if that and you're you're of the part the system treatment. immune the doing cases,

are to other address approaches trying all have the these of systemically of they that widespread important these other occurs problem and causes parts critical that functions, immune of system don't and the diseases. All attack

So is And Dupixent of Dupixent you've also be concerns they're not. as safety work, work already one in come may other indications. they don't failed but often in various to work, agents, the they because they they seen if immunosuppressive, they which about indications, with designed with

have million attacking by to explanation you're a it of in on that would many special safe a the and the part the predicted that this drug, add neighborhood safety the George's why of because Dupixent so people such at somewhere So what small prediction point vestigial just be drug of the immune that to science. system, is that it's X.XX more looking the eloquent demonstrated is than

Including in know, is as we as efficacy. there young but children, where safety it's been approved months demonstrating incredible X only as not incredible

Shannon, I think we have time X more for questions, please.

from Dane Raymond comes Leone question with next of Our the line James.

on a strong quarter. Congratulations

for Just actually ones quick X really me.

of biosimilar margin commentary transient and seems some of on ] but potentially more had favorable one saw biosimilar there. you from of highlighted opportunities which ranibizumab to the use increased EYLEA impact your utilization you interested First [ of impact whether be any can high-volume quarter using from being, [ clinics it brands, the be just ] sales. would a in number during A comment anibizumab

EYLEA. is awaiting in patent your inbounds have case. just of how ongoing lot you for the life? you litigation that what of gotten just for terms we're could your ruling And any base state current of a actually thoughts then expectation us Eylea we've on And just Could impact patent maybe

Yes.

the marketplace. insight cover and Marion I'll additional then patents into the So cover any can

key On the relate couple have patents that as evolved well formulation litigation. case patents, this of as a to that dosing. both in There's we're in involved

base us, upside, but that happens franchise. May, expire the case an in be the is exclusivity which will see could assuming obviously, On will litigation, the the in what that, for we for

in biosimilar ranibizumab quarter, the and -- the to which low the declining to has third single-digit the their on been area Lucentis, impact, there it's this share. been launches, And certainly, has The category. relative But HD. impact more All notable certainly, and relatively extended Lucentis right. seen the impact early EYLEA in is in hasn't shares but to not a

please, our last take question, just We'll Shannon.

question is the of Baird. with from last Brian line Skorney Our

bispecific. their first quarter It good looks like J&J of a really had myeloma

there's good So a a demand it definitely of an element like control them for of offerings also of there. seems myeloma. having But lot

the take strategy always what as So each market? share? oncology, for but would Or competing kind of enough your market wondering dominate really earlier obviously, I'm Do just of on next your launch combos data line to kind there is in focus you is share? late data initial [indiscernible] generating move to to a think initial with is differentiated bispecific in in of the of year. the third up line here that

in show best-in-class continuing maturing data of and terms Well, result of of syndrome response in And efficacy, rules, terms best, response profile. And convenience forth. data, and evolving both. mandated complete in of cytokine will We hospitalization. of profile and of the rates terms that safety, it's believe efficacy, in terms of the release frequency both in rates in so we course, also but in could terms do safety we be which believe to our terms differentiation of

So our we will be continuing to present data.

efficacy, what the ultimately all moving And for is exactly as also therapy. future with, earlier of in And we see course, be terms of convenience combined an in FDA of our safety schedule. what there's we'll label lines going the potential program said, you of think, course, in opportunities we're for this and to but and supports also with here exciting combinations. Of the the gets best-in-class and differentiation

agent have of this the setting. dyscrasia about costim that cell We excited specifically a we're variety combining plasma bispecifics with in

think opportunity. a very exciting it's we So

patients there a a As out are opportunity large still that you said, because there's need. there's lot of unfortunately, in

to of that that in combos agent with want alone we whole think takes And really best then demonstrate out the next best earlier-stage if people enhance opportunity utilized our magic if the have it. to lot I program let A it be one patients. how that can figure certainly for we you it use that level. to the if patients up late-stage come can of

that who available to in have. and team the a is Investor have questions you interest apologize thanks remaining from. to in Okay. remaining Thanks, those do your day. answer great not once and Relations chance in any everyone may But as dialed queue we Thank you a to and here today to George, the Regeneron. for hear We have always, again,

today's conference for concludes joining. This call. you Thank

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