REGN - Earnings call 4 2023 | Regeneron Pharmaceuticals, Inc.

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Operator

Welcome to the Regeneron Pharmaceuticals Fourth 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, Senior Vice President, Investor Relations.

You may begin.

Ryan Crowe

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 fourth and earnings call. quarter to welcome available shortly after call transcript call of An the Regeneron archive website will ends. and be Relations Investor on this the

Landry, Joining me Executive Chief and Bob Board and Chief of Scientific Marion McCourt, Leonard Dr. President and Co-Chair, Chief and and Commercial; President President today Vice Co-Chair, Vice Dr. Officer; Co-Founder, are Vice Financial Head Fenimore, Executive Chris George President Schleifer, President Co-Founder, Executive Yancopoulos, Board Officer; Controller. and Officer; Senior

next As our upon know, Form already and Bob's Bob after filed is from Regeneron's next week, Regeneron appointed many CFO of XX-K been Chris retirement. will you has retire become to

remarks, remaining your approximately XX be available prepared anticipate call our will the will for today's time minutes. last We questions. After

but statements programs those products matters, include financial reimbursement I'd anticipated Such statements like other and call today's and and to may pending property, include, not finances, proceedings, collaborations, coverage remind competition. milestones, and issues, on related payer you about development and and guidance, its Regeneron. made forecast to litigation Regeneron remarks are limited forward-looking and business, that regulatory may intellectual related to,

undertake obligation information, result as SEC Regeneron expect statements, forward-looking its which year to is Securities to can with or Exchange material update results the and with statement. on future statement A other complete in ended to a the and forward-looking more any Form not States from any and Commission, subject otherwise. December that projected we the found actual X. uncertainties new for risks February that does in Each Monday, of of Regeneron's events events risks United XXXX, including materially could cause and those to differ file be description XX-K filings whether these XX,

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

IR ends, any to available Bob, further let Chris Len questions. that, Once be to and Officer, and the me call the Schleifer. our Chief team Dr. With will call Len? answer our President Executive over turn

Leonard Schleifer

and you will year Thank you strong Bob to call. joining quarter and financial for you, thank everyone through today's walk Fourth XXXX capped Regeneron our Ryan, results. another

briefly year sustainable then to back year, come the several discuss was For highlighted X that in by company growth shareholder imperatives. the achievements of At and year long-term and to another the for deliver to my start like value. today, at XXXX identified key Regeneron, remarks significant what's position look strategic the I'd we ahead. better . XXXX remarkable

approval third-party obtaining due First, and delay approval the at encounter mid-August. was issue launching HD received a FDA an June We late to granted this successfully complete minor a EYLEA when in letter and in EYLEA response filler. remedied did was quickly HD. But we

minutes. will is HD believe degeneration macular with profile, With diabetic we wet for care Marion is diseases. clinical and which what in a eye to of discuss patients age-related a become great potential best-in-class The standard to new to EYLEA the be launch a start, poised off few

to in and and both launches. We prevailed best broad could that formulation and biosimilar biosimilar may one to related delay a to EYLEA. case in aflibercept had which a This our was intellectual by our valid presented the patents aflibercept have of decision found District Court, we manufacturer. infringed Second, EYLEA's defend property implications result favorable

basis patients approved indications suffering to only from $XX.X led net currency X of by even did a on Third, global in diseases more by further its constant by both. product Dupixent other Dupixent all States needed grew growth Dupixent approved also driving Sanofi, in and previously continue billion. sales indications. the driven new-to-brand XXXX, we X our penetrating United XX% inflammation. not to reaching across Type collaborator, In we by prescription share

the to We also major with COPD and or a evidence study, disease, in we FDA breakthrough additional chronic inflammation. on March, feedback, ] results, December obstructive evidence on launch we a summer had pulmonary out [ efficacy granted Notice analysis moderate-to-severe this mid-XXXX. submission for regulatory from required conduct compelling The sBLA study which X indication and interim as reported Replicate the designation which decided support disease read early Type our enrolled COPD. and strong of data potential this Based the therapy an similarly of breakthrough as a patients Sanofi In BOREAS U.S. filing. to but during uncontrolled enabling

submissions solid toward long-term our making in by Fourth, myeloma, regulatory progress global goal of oncology. in bispecific in for to tumors. lymphoma, our bispecific CDX BCMA our other and while we linvoseltamab, highlighted advance continued by our becoming in XXXX was odronextamab, opportunities CDXXxCDX a leader continuing

long-term including needed our of medicines, of intriguing well presented and And or And hematology proof advance pipeline. we to mechanism as early-stage finally, data genetic proof-of-concept XXXX, we course as other opportunities over across the areas, will few nonhuman can Many that George with minutes, best-in-class from programs, believe for obesity represent early these first through or data which run growth drive we Regeneron. a primates. in of

XXXX entering Accomplishments of strength have in XXXX. position in a us put

from agents. the is continue EYLEA especially with other the of For strategic accelerating this our execution, of one to commercial the anti-VEGF of goal of imperatives driving HD, ongoing launch year, pace conversion

achieved Another Center for which into X, at EYLEA important will Medicaid J-code effect on April month potential and a be physicians concern permanent XXXX, a last HD reimbursement that Services removed. for Medicare assigned milestone go will point for when the was launch

Dupixent currently approved, would continue If launch the of drive COPD the potential to as suffering for in as an to eosinophilic COPD. form this approved approval indications be need over FDA growth first would ever United meaningful biologic and Dupixent advance XXX,XXX for the States in first represent the its a from also decade well with the from We in in improved phenotype. and COPD patients

aside year, from the this non-small excited of myeloma. for linvoseltamab, on are skin we build cancers to Libtayo of the success about cancer, of in non-melanoma best-in-class potential the cell odronextamab has the oncology to bispecific and lung which and latter the In launches continuing be potential

studies. melanoma We antibody squamous in our also cell in XI in expect pipeline which in advances non-small cell with cancer. for our Libtayo readouts pivotal and Libtayo may to in adjuvant across antibodies Factor our thrombosis, with fianlimab, make significant cutaneous XXXX, metastatic and LAG-X lung carcinoma key combination inform

trials obesity, addition hemophilia atrophy, severe and studies co-stimulatory in geographic expanding and of early in We CDXX food in B programs allergies, hematologic also clinical bispecific plan to malignancies. solid to initiate our

and a strong and are in poised to had beyond. In deliver XXXX closing, we XXXX

of pipeline clinical programs over is Our delivering XX and important differentiated innovations.

to And to deploy commercial look to capital over is continue time. well. ways Our team shareholder we at efficiently drive returns executing

it to hand Bob as over I Chief over thank many Regeneron I his Landry moment his XX Officer. Before want George, to years contributions to for a take to our Financial

thank to and mentor financial many of around health improve addition leaders, needed and continued and current the fortify to to you, world. results of discipline, and drive we help lives Bob, ensure the worked incredible good have has been you an we to and patients past over Bob In happiness. the Regeneron our strength Regeneron's decade, future behalf the of the helped helping tirelessly on resources wish financial Regeneron's family, entire

Chris and closely announced September look with We organization. Regeneron. financial first forward Bob's knowledge we role will continuity he next working the collaboration all Fenimore of retirement back As depth the to Chris rigor new that brings knowing become in ensure and similar in upon will week, CFO a across of his

With to that, I'll the over now turn call George.

George Yancopoulos

to impressive really overview, I was That say. Len. have Thanks, an

medicine. year delivered with by the change all as well the of to of another practice was which firsts XXXX as potential Regeneron, collaborators, have our together of

inflammation and with immunology. Starting

the transformative COPD planning As approved Dupixent, in for yet you we are treat, Dupixent's class. COPD, potential which the sixth to be that IL-XX the and had launch a first is severe COPD rate would exacerbations the from annualized moderate, for treated medicine disease heard antibody. remarkable this in eosinophilic in in is which another based would were time trial, that represent unprecedented by fifth which Phase our this from second it III our blocking Phase Dupixent then Len, confirmed Difficulty] [Technical XX% reduction of III patients demonstrating notice, results on first BOREAS, trial

an results the potential for smokers, in reported even annualized data was to paradigm observed, XX% pivotal a studies Phase rate anticipated If transform I approach II track readout reduction from COPD. where RFI and these treatment in passed with last XXXX. interim now enrollment The are analysis futility [ II an in studies year. III ] XXXX in complete Phase [indiscernible] has the the the to studies on exacerbation further The former

BCMAxCDX treatment year, receiving approach an Later we intervention allergies a planning testing of are for food new severe transient in Dupixent bispecific using therapy. this patients on innovative combination

As are IgE. of for stands allergic of you many E pathologically is many high know, or levels in This IgE by immunoglobulin the driven say evil. the E responses why

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young will looking just from death forward exposed severe a potential We highlighted yet people as another believe week allergen. are food unknowingly for proof-of-concept of a the this has constant tragically person to this allergies which small inform who approach reported starting study, the the by to program. We at suffering risk, widely to millions of benefit steps last are next

PD-X basal or carcinoma. metastatic Libtayo carcinoma, to cell non-melanoma antibody CSCC, skin oncology. leading and cutaneous cancers, is Moving the squamous for including cell

from of second indication include are the we the this expanding currently results setting the potentially interim And pivotal adjuvant year. We potentially to CSCC. forward in expect approved in half CSCC to analysis looking

most with LAG-X the Libtayo Regarding advanced our combination is fianlimab. our combinations, antibody,

most in cohorts XX% combination first-line exciting to melanoma XX early checkpoint profile seen metastatic progression-free for than reminder, our early of PD-X estimated approved combination data As efficacy clinical longer and that clinically anti-PD-X potential product, when compared by combination anti-LAG-X examples safety survival a median of data Libtayo-fianlimab greater with response the that cross a demonstrated and inhibitor clinical rates monotherapy. the trial one the best-in-class of suggested meaningful is with may than These objective with separate benefit the with be that highlighted similar months. X

end readout year. are expecting the We potentially from a melanoma metastatic pivotal our trial first-line this of initial by

Phase anticipate XXXX. data in late also cancer cell lung II We in non-small

have we with starting by Libtayo, EGFR with microsatellite dose tumors. In cancer observed bispecifics, CDXX of activity our ]. the in to promising costimulatory colorectal doses of On higher solid [ combined bispecific stable Decostin trial escalation with

In ]. tumors terms not with half forum which we the data, events immune-related across we Decostin far, initiating later encouraging a of these increase of solid seen be on several Based the cohorts year. safety, an early have scientific year, will be so will at this presented in expansion first adverse [ in

In and XXXX, our MUCXXxCDXX provide advanced program in also MUCXXxCDX for are we planning to updates cancer. ovarian

oncology. for Next, hematology our bispecific

or of supported are in for safety, myeloma myeloma, begin submissions best-in-class by late-line disease submission well convenience. submission. as Phase myeloma patients. efficacy, acceptance as expected recently in profile accepted III were BCMAxCDX as as For stages the study terms BLA will A FDA is well linvoseltamab, And bispecific soon enrolling confirmatory month. or potentially our in later of studies multiple MAA EMA a and enrolling this premalignant our dosing, These earlier of

by date, the second PDUFA our expected the year. March of lymphoma, For non-Hodgkin new odronextamab, decision is is for and XX FDA its ] in the our decision bispecific for the CDXXxCDX expected [ half BLA

week, formation In news and are and the rights for oncology Regeneron unit, Medicines investigational of acquiring immune this for our cell immunology of Cell terms pipeline therapies. commercialization of development full recent that Xseventy and bio's we additional announced we pipeline

certain by efforts. cell and collective on many including to Regeneron other diseases work continue of programs medicines excited capabilities have deal on opportunity XXXX about employees closing, are worked the join Regeneron's and ways, will therapies. Xseventy continue Xseventy serious advancing with to with and addressing After combining antibody cancer since CAR-T our in these We novel

muscle accounting been diseases. surrounding future. for has that in the XX% to weight obesity for can accompanied and from much the This may irretrievable muscle loss as concerns health loss loss. to agonist as and obesity, GLP-X potentially Moving all it oncology the metabolic Despite weight patients be to major for up substantial enthusiasm public by is profound the of even increasingly and catastrophic lead recognized immunology loss,

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In mid-XXXX, first we to in combination plan of the to muscle preservation combination clinical evaluate start our our trial with antibodies semaglutide.

trial replacement on in or are year. path volunteer registrational we XI coagulation after is thromboembolism a development of demonstrated late venous blockade our this next Factor the approach And in more antibodies preclinical program anticipating complete proof-of-concept Factor rapid approaches healthy to data, Based setting Also and competing a the a of for starting for to data XXXX, knee year early disorders. antibody in prevention surgery. XI compared on

with in conclude medicines. now our efforts genetic We'll

received including siRNA has and Our diseases Alnylam targeting principle patients for of this for with to year, anticipating was last data this demonstrated as are in looking program siRNA, mutations. Proof we multiple Based siRNA CNS collaboration the additional the first for year, brain. SODX year, such entering from and that achieved time clinic who new we liver, the from the of programs forward genes success, have with in for silencing the ALN-APP successful on ALN-SOD patients doses. ALS are

on IND with the studies Intellia CRISPR-based clinical with Intellia, is we to first potential our amyloidosis program as produced TTR use editing recently also B. initial continues human portion of evaluate in initiated for disease. hemophilia lead-in gene to insertion in III program of gene our and first enter the of now the a to lead States. a to technology first clearance program beings. clear be where editing deficiency CRISPR insert CRISPR We to pathological with advance, to corrective United CRISPR-based the gene together for collaboration Phase achieved for we Together gene cardiomyopathy cure indication in for a hope Our in of it vivo CRISPR example gene IX Factor a for the trial This

child gene announce treatment with from hearing hearing genetic restoration genetic company We U.S.-based loss were to in Moving a loss. young hearing the approach. first after to novel therapy suffering our

this We by common our cells to of delivered ultra-rare programs of disease advancing forms inner locally case, these look of are data in excited clinic therapy These and to to forward hearing this for results viral-based validation early additional the more represent ear. potentially gene program, loss. the the address monogenic

to progressing and to the Based to these we monoclonal we non-amenable our in muscle be as efforts, these data, to based approaches virally to the significant will in made and agents coming specific years. have antibody deliver directly such delivery, bispecific tissues leveraging genetic-based central preclinical systematically clinic Beyond encouraging the investments use on system. to payloads body these local expertise nervous the in

with cotreatment encouraging with convenient our another shared complement could levels and of a efficacy involving Normally, this siRNA target with dramatically regarding recently PNH, hemolysis initial lower combination an and of in first-in-class of We achieve with concluding combination an dosing. control hypothesis better the more in case lowers that antibody target provide CX notable dosing. allowing high to Phase convenient antibody levels burden, III breakthrough this antibody, study efficacy needs patients But a supported more of from data approach one Finally, sufficient our because to siRNA CX target. high very block [indiscernible] CX. program which

our extend continue in We're to planning studies myasthenia enroll and gravis. Based approach to Phase III on AMD. combination building these to PNH this atrophy dry we and also data, geographic and

delivered elevated this eye for cases but which in potential manageable serious risk the have vision. directly we are resulted over expected permanently to including approach infections, have inhibiting believe GA retinal is of has approved While rare several agents resulting impaired into sometimes that in combination systemic our of recently vasculitis, advantages toxicities, and complement

grow deliver in firsts, differentiated forward continues engine In conclusion, and looking many R&D and additional we to including opportunities. early, mid- Regeneron's progress are And late-stage to XXXX.

would and call his Bob to I and team. and Before to Marion, turn Fenimore look forward I over add years efforts I and for many to welcoming turn of leadership Chris adding over devoted Marion. my appreciation like the to our thanks leaderships, With that, to it to will

Marion McCourt

George. Thanks,

and the results quarter strong delivered business year. Our fourth for in the

XXXX, expanded of in several this therapeutic categories, including launched look lung year treatment successfully to cancers. We new with potential in HD, EYLEA and approved new and and type hematologic diseases, course grew the Dupixent presence forward in modalities. inflammatory Over non-melanoma using X Dupixent Libtayo's a oncology we COPD approvals skin across

and fourth of early as I'll HD being patient its agents we demand patients. combined based EYLEA, sales use treatment-naive used EYLEA EYLEA first HD branded announced retinal broad in U.S. franchise. start were $X.XX our those already other HD experience. net or January, as types, a growing In on EYLEA from and well across In $XXX range physician is EYLEA million, product of with net positive switching but modest sales quarter product Avastin, including full quarter, billion. increasing

fourth quality a safety the differentiated EYLEA market together short-term category anti-VEGF as secured a despite compounded has that due dynamics. as a supplier to gain the XX% EYLEA issue since medicines HD in Avastin changing quarter, disruption of of our resolved. driven increasing share, efficacy and was This In profile competition the share large been and at and by well

the eligible of step lives edit line fee-for-service, have XX% HD. jurisdictions launch, claims majority total access are than reimbursement J-code. use, category Medicare securing now and are progress approximately represents across significant access. XXX% of made being in of a first single paid Since with which covered, having X/X using More vast we or EYLEA for miscellaneous

we by typically in that EYLEA a miscellaneous and remind ahead reauthorizations Looking payer that you HD XXXX, first J-code. is will quarter subject to the impacted remain

However, go additional a hesitant experiences into EYLEA on effect a in J-code other with of late we for on physicians their permanent X. important permanent January, achieved confidence prescribe J-code disease with before to those medicines. This CMS's assignment will launch milestone based reimbursement for negative HD eye that provide new April another will

very are we franchise. of the Overall, future excited retinal about our

in new both prescribe increasingly settings as continue HD HD of care. standard to EYLEA the treatment-naive and We see treatment experienced as recognized is physicians EYLEA

where XXXX of billion is one quarter sales XX% on most across medicines for to the of grew important currency $X.X billion. the to grew fourth diseases. therapy Dupixent to on worldwide, Dupixent, net spectrum global Now $X.X U.S. XX% constant XXX,XXX a sales patients basis than more net patients and With biologic

Additionally, to new potential significant on indications. based have it and upcoming growth continues

Dupixent share new-to-brand indicator In leads important the for across all U.S., growth. future indications, approved prescription leading X an

total prescription share leads In approaching share addition, in asthma. approved or leadership in X indications, Dupixent already and are biologic we X

to the as differentiated In to including quarter course safety age. Despite patients third share competition approval atopic dermatitis, in Dupixent's of X increased profile, prescription of Dupixent largest compared XXXX, trusted modestly as months results sequentially the of increased action, fourth indication, over of AD choice. young a driven as new-to-brand Dupixent quarter and clinical by its mechanism prescribe in physicians XXXX, continue therapy

supporting dermatitis. this subset Dupixent's is hand use disease. biologic for or medicine U.S. patients the with the data efficacy with severe atopic recently to patients updated label only Dupixent with of data label and was hard-to-treat in this for foot moderate with safety

for young being have for initiated patients of in pediatric year to growth the prurigo XX,XXX The asthma nearly esophagitis, therapy recent treated FDA's Beyond blockbuster eosinopilic indication in polyps, performance no also DUPIXENT's are which in U.S. treatments, and U.S. indications EoE of in potential. In which as further nasal XX,XXX patients children continues contributed as FDA-approved age, alone approval as atopic both unapproved of the EoE, prior extends on already DUPIXENT's this had where in Dupixent. known X recent already EoE launches therapies. nodularis, approximately with Dupixent approval EoE, indications. significant of represent dermatitis, The to growth and to

and nodularis, biologic of prurigo its is Patient initiations of conditions. anticipate also this approval eosinophilic generation summary, as standard We pediatric the In most EoE preparing already Dupixent important with growth. potential care we of for multiple FDA the COPD many pending launch significant potential for to medicines solidifying our remaining continue bringing in Dupixent actively The patients are year launch to to accelerate more in on as indications. later across dermatologic this Dupixent delivering opportunity approved Dupixent year. is one underway,

on million, net million. currency in non-melanoma And quarter Libtayo. cancers, global net lung year-over-year progress and finally, Libtayo sales we've to penetrating the of to $XXX lead with sales made U.S. category skin in to basis XX% constant non-small a the $XXX Fourth grew cancer cell continues market.

across indications, growth all our continued $X expect exceed annual we XXXX, in net billion advancing goal In sales. Libtayo to

across conclusion, provides XXXX opportunity Regeneron's therapeutic positions with market-leading the build areas. medicines In even more further to our

Now I'll turn the call over to Bob.

Robert Landry

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

with ended Regeneron fourth strong the performance XXXX quarter. in

increased revenues from from launch margin Libtayo. contributions sales to EYLEA and strong year-over-year Ronapreve, from growth billion, primarily of driven by $X.X growth sales and the HD total expansion Excluding Dupixent XX%

was Fourth share $XX.XX net billion. quarter $X.X income diluted on net of income per

ex were year. $XXX $XXX on to revenue collaboration product profits versus to Fourth prior EYLEA and million, up collaboration which currency related a revenue Bayer. sales U.S. quarter share X% the with million, EYLEA $XXX outside the Moving Total U.S. constant XXXX million net our Bayer of net starting was basis of

in revenue $XXX XX% collaboration quarter Sanofi fourth grew XXXX to of Total the million.

in fourth Excluding million grew milestone revenue Sanofi XX%. collaboration sales a XXXX, the $XX of recorded quarter

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

profits. to decrease the as net was our balance $X.XX of Recall, Sanofi collaboration of this the compared At the $XXX decrease the manufacturing XXXX. prior end a higher-yielding XXXX, million due a new of primarily revenues, component to of billion, to development is a reflecting supply, declined XX% as reduction implementation commercial the year of collaboration versus a Sanofi of share XX, of manufacturing balance for recorded Reimbursements process. December

reimbursed We significant result Sanofi our in to fully continue years, a next be balance in this few the to which in step-up expect would collaboration profits.

of $XXX Kiniksa. was and Alaris The fourth million increase of increase in XX% other supplies revenue our higher an Arcalyst Novartis by higher driven ex-U.S. for on royalties revenue primarily of up increased also Other prior shipment of XXXX, Praluent to share in commercial the in versus from from reflects of quarter sales reimbursements Sanofi. year, profit the volumes

$X.XX our Moving quarter, activity. expense grew investment late-stage continued related Fourth costs, R&D now to in to and which SG&A year-over-year to our XX% funding quarter of HD advancing operating costs billion, for launch increased R&D the related grew XXXX from was expenses. expenses, and higher growth EYLEA primarily and to including $XXX reflects higher headcount XXXX year manufacturing in prelaunch in anticipated headcount activities X% programs, hem/onc costs commercialization reflecting and product an launches. our growing pipeline. million support by the prior higher of fourth driven the clinical

XX% we COCM quarter reimbursed prior from these year million. costs. Fourth that declined for $XXX quarter are Recall the to

repurchases. XXXX, repurchase billion XX, back shares approximately approximately billion and our worth make our Now shares sheet. ending opportunistic $X.X XXXX, In began of billion with repurchased and have less of $XX XXXX. to approximately we generated cash in for repurchasing $X.X we of balance authorized flow planning Since bought billion to free XXXX, Regeneron continue cash $XX.X as cash debt with $X.X the flow, year remaining billion. to marketable we In and over securities December in the

the of the XXXX. that guidance to Note development our guidance with that Now for announced to to $X.X from business to as which not $X.X transactions these anticipated expense XXXX, billion. recently billion in of any ranges range today, completion and agreement completed financial is including were Xseventy not programs moving Starting acquire our of bio. assume in clinical preclinical be do R&D

earlier our studies discussed George III this expand, our highlighted of are Phase expected fianlimab, for ongoing and These with as growing number to linvoseltamab studies initiate of JPMorgan to As lines conference, the in year. and we a potentially studies CX registration-enabling pivotal in include pipeline programs. continues odronextamab at just

the new addition, X clinic expect In we bring to XXXX. XX to into molecules in

billion We and for headcount in hem/onc range of inclusive product This to the XXXX ongoing our the our increased to ongoing of activities SG&A higher billion. expect launch expansion. to $X.XX anticipated support promotional to support spend of investments EYLEA be launches HD X growing $X.X organization reflects international

$XXX as expected component of of to Bayer. we costs Recall, a by revenue, the higher This drug for and production for including range reimbursement HD we result, is for products, be substance recorded COCM to million lower million. for COCM are which Dupixent other in are manufacturing Dupixent, from expenses reflects as EYLEA collaboration reimbursed and, to slightly expect to lower range Sanofi, in collaboration $XXX offset compared volumes, a higher as XXXX. Sanofi be costs XXXX

to We margin expect the XXXX XX% of range sales gross on net product XX%. to be in the

range to tax of XX%. our We effective to rate the in XX% be also expect

to of New facility York. a continued facilities Rensalier, expansion headquarters, as manufacturing million to reflects well million, ongoing at capital our construction Tarrytown, expansion Finally, our which we in of of as in expenditures range $XXX R&D be $XXX New expect the fill/finish of including capabilities, York our

In payer Praluent U.S. net XXXX as addition we guidance, expect product compared to be XXXX to to coverage. full to due sales of year in our changes lower in

We also all the XXXX in be with sales fourth expect Inmazeb in XXXX net revenues recorded XXXX product for be with quarter. expected to line revenues to nearly

Finally, we XXXX first half. line than anticipate be with with expected to XXXX, second in in other the our be half higher to revenue

company position our to long-term XXXX value. in shareholder the well drive performed continued Regeneron investments Overall, and

management conclude, with I have honor of Regeneron's appreciated as for their I'd and Len to community. for medicines thank continue to Before Chris and I utmost of all CFO patients he Fenimore these breakthrough serve will each for wish kind to past team in role like George and been and XX in an and rest I sincerely investment the deliver of have shareholders. confidence you words. the has It my success this that value much the the years to interactions

will With I continued and all call you, you the wish that, success. I Ryan. to pass Thank back

Ryan Crowe

remarks. prepared our concludes This again. congratulations and Bob, you, Thank

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

Operator

Instructions] comes [Operator Cowen. from of TD Van question first Our Buren the Tyler line with

Tyler Van Buren

look Bob. I'd to wish as a well say with your you Chris, And with Thanks, been forward retirement. to you. to well. privilege work Great. during It's like you and you to as working I well, I congratulations

the Len of to the agents rate in So accelerating other from opening, of HD. conversion EYLEA mentioned patients

the over permanent which discuss year, you mg can J-code sampling impacting also rate that the different the I So and the assume at robust factors will is X accelerate includes play sales? that effort a

Marion McCourt

I'm happy to Sure, answer. Tyler.

as mentioned, number EYLEA market, of in very the performance by we're the are So that early I factors success. HD driving a early encouraged of and

clinical EYLEA it's the First, and setting . showing the efficacy, durability real-world is which of market factors. the safety very HD, actual in now data, all important

mentioned, the cases, look and patients. their physicians conversion in As naive And is experience upon also, build prescribe a we and in forward, the I Avastin, J-code. have will to ongoing broadly, some to that, from for I to agents early But would very, that a future, that from as confidence, permanent branded experience. important coming going is product are consideration reimbursement some addition share and hesitant doesn't physicians, experience very patients

the recent that progress to those in to addition market with So X the, coverage. beyond has occurring is confidence, forward then important, most certainly, differentiating payer very look we EYLEA product. We CMS's physicians. to on of in certainly reimbursement we've date and HD And favorable experience that And made in And do anticipate April based probably, the more. been the for making characteristics update.

Operator

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

Brian Abrahams

could portfolio wondering both into move and shows wave a patent obesity you was differentiation very bit that talk if the I revealed models. animal know GLP-X Chris. a about the maybe the loss of as Bob studies. tethered emerging the of you weight I little next in to competitive antibody filing Congrats

And dose know GLP-Xs. where on in myostatin or of top I or you differentiating well So else? most. as see Is I'm it are frequency wondering pursuing distribution tolerability that then others somewhere

biggest curious see advantage Just where you your there. competitive

George Yancopoulos

size: people growth control Other or terms them who the X X. with the have Myostatin key but and discovered And related that we in the blocking we're X, antibodies approaches, Okay. of or latter X preservation. only And ones Well, that first, have there [ for we're let start the are Myostatin ligands ones factors ]. muscle we're ones, it, testing are ActiveNA only we those call individually. that specific muscle together myostatin, and me

to And here. combination efficacy a the going why it's that's and be safety matters reason both is that important of

safety see So here. GLP-X the of best agonist safety the important the think of going approach to going does terms that so so you loss preservation can And which treatment. the we're that see because the also But going profiles. we're be see is face in critical muscle to profound with to in that's I muscle

factors over And are Other others and be diverse the the functions, broad myostatin, people to one by many receptor a believe, benefit I are imagine used these factors. want up the not which intended approaches and are dealing just are The patients. very that testing that used obesity end can and all as of these alone. block having give these be testing receptors the by with in with by that's agents to body issues receptors approach biologic treatment you have other that trying to diverse very dozen able loss you're blocking of easily sorts to of functions. weight so also the setting to a might is to that safety optimize ligands problem going you such the blockade for

programs factors. are X growth regulators, different very So our X discovered key that key the we the in

We vis-a-vis well preservation them in the best see together separately muscle as them safety of the to receptor evaluating what gives benefit agonist, antibodies and have us GLP-X And profile. setting as both. separate we're blocking

we we're this While developing said, initiating that, also we're year, as doing unimolecular solutions. those trials are we

So molecules. set whichever of the to associated have you with works the right antibody having put approach tethered as GLP-X, hope it, we best, a possibility of

terms complemented hopefully, approach. weight So with the once-a-month of unimolecular convenience with weight profound but receptor profile providing, loss but agonist, they the best benefit loss, provide in [indiscernible] solution the dosing, have only possible not providing one by that will having muscle now advantage with safest GLP-X providing the the is of together and that potentially a all-in-one seen can

these And that think So the possibilities. very addressing terms have of excited most we're unique program we all we in programs. these very, about

Operator

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

Mohit Bansal

over how trends there? it's outlook see just as for ] fast, Bob, the do down Hydro you, EYLEA fast anti-VEGF plus Can that the the in mean, are help out one market, in little all the Maybe question EYLEA And you Marion. forward, been as a slowing in Thank is on you is the or you years. your the for with for context, I comment underlying trends? or underlying market bit? growing the it demand [ going past, growing

Marion McCourt

Sure, Mohit.

population years is though, a anti-VEGF category So on diagnosed unfortunately, brighter it number the note, individuals is from growth Overall, of aging with On healthy based category is good. to quarters as diabetes. variation and standpoint, with diabetes the between a relates there growth. or

So overall, category healthy growth. as see we it

been an last example, overall. decline of and points this But year some couple there there is variability. has as And between by year a

Operator

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

Christopher Raymond

another want of of know that, just too a guys sort revenue not been issue. last you share with in pricing struck really our the market question. it's EYLEA on the format even don't X-milligram contracting strategy, show couple your checks get Maybe to but quarters, we've that granular I

In fact, an remains up that around share of format high. all-time

that's So been that's erosion think been one would that. that price driving

in in of can broad leveled expecting price for off? strategy have what a stroke, erosion Do should launch, we HD be Or further expect be about the may things maximize XXXX? this to talk understand sort X-milligram that you format? Just you

Leonard Schleifer

strategies, we add Marion rebates, the that. we to could you want It of erosion HD. EYLEA intended yearly think to some been new was We priced It a marketplace. basis. the starting some with on on we well. it a as we of into at that competitive details was price Marion, our products There a can marketplace. received thoughts, sure has things in But the get it view point pricing, match very not say, I'm well. Yes. like We're

think price actual the so And fine. point was we

like I add at wants dynamics. competitive to to those all, know on we anything Marion don't comment but specifically if don't

Marion McCourt

nothing to really add Chris, everyone to that. Yes. in

Operator

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

Colin Bristow

on potential on assets? best or sparing targeting, are couple concerns is And all myostatin more regulatory volume, in sparing increases then what thoughts muscle would your muscle the these the that the muscle for George, muscle Maybe preserves you program. thoughts of I'm a the utilize the Bob. the curious, any around but future, pathway myostatin And less functional.

George Yancopoulos

Regulatory.

Okay.

in believe models. antibodies these point already done all, and We that view. preclinical work So important of of is our are And actually very both functional been expenditure and have we've studies this first extensive energy humans. that in showing from certainly metabolic muscle the

so far, supportive So, studies are of very approach. this whole those

loss, so as if Alternatively, Obviously, then and that in that quality loss, is white in might and there's which of I would here. variety weight possible studies, the functional a show strategy. come strength a on. the it's terms the outcomes suffice the the there's have we're say should pursuing from also incrementally of results we're if just forth regulatory would we pathways easiest, animal regulatory more so of to that seeing

thinking. still early in So those are the

loss, more also have composition And loss simplest see said, if may increased see these muscle, I weight which see data, also you that better approval. we But way We the and to be also metabolic provide in as be simply we may forward. -- which pass-through weight better have could body additional initial then would from but studies. benefits,

depends we're it that the studies. results going initial on those get to So from

terms have I have, to that are hope results that that real these that questions we additional other doing in a are obesity. that that inform be we're remember, But validate in in I lot earlier really mean, of terms the getting years of and really next over should year, programs things doing we're we course are that there's here. as in could trials here these the and X.X and of promise stages. clinical mention, well also of all things now obesity you these

example, ever in the one discovered. electronic data the obesity using of we health human of some brand-new as know, new linked Regeneron on our you in obesity been Genetics terms largest ways, records, a exciting for set big sequence most Center, identified, and in discovered that's targets the in So probably planet to target promising

of a using we JPMorgan not-that-far-away siRNA that approaches in in terms data GPRXX, And we approaches at weight we of variety that or called target this about so blocking year in and think it look have promising presented a ago. was from variety, Science exciting. the loss. a early have a for prominent it's I And very paper published clinic preclinical And

a data smaller programs I so of very very antibody that, should have we also as receptor-activating like things human well. in had forth, mention leptin terms have exciting promising and that

is over X.X on, I a to be interesting program of there's very goes years. the and preservation So muscle things how at lot going but year, think to forward it the next going look

Operator

question Seigerman next of Our Markets. with comes from Evan BMO the line Capital

Evan Seigerman

for Bob. have final question I one

done the and an helping of financials the past business shareholder So returns over outstanding managing Bob, you've drive decade. the job

its next the in use everything, how you Bob. of for Regeneron? can ahead, cash decade believe rapidly Regeneron thanks further Looking best do returns growing investor balance And drive to

Robert Landry

for show video was thanks were we at that able and party. the thanks to the question, retirement It Evan, great. for my

have over Chris, that our research to XX kind a X a funded. earlier regards to we is just opportunities coming, so of On they're I within And to we're the but opportunities, that, make kind George going allocation regards the clinic lot to out development. mean that do question, INDs. of as priority bringing and his of sure continue is to just and to there's George today, again, I'm with laid fully that making many mantle #X kind with capital to particularly sure Len to do I and great what and into when said going job hand

much bought at too with, circled we on that good price. the he'll have buybacks. back that. regards But what here and Proud that methodology do Maybe ingrained much and continue is of victory I've how Chris to a kind on to with we

it be business to development, modalities. be we're just because going has I And to to mean, with doesn't force to It to we has a regards has franchise, mean be something. can right,

of incremental to we have the to that. of be regards to kind with the what clinic George targets develop, and that has currently we and in here RGC You've heard all mention

will remain we on So prudent that.

the free put proud generating. use. the that Board trust will to that Chris, and great optimize And Len it be flow cash it George, of I Continue and we're to

Operator

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

Salveen Richter

systemic will the Bob, next the here, approach data be to you here. truly seen it you contributing and to regard missed, With animal Phase move life what's of to And to stage in enjoy support III? your GA given can from program, the and outline what confidence you've models your

George Yancopoulos

atrophy. Okay, geographic

the we the the terms And had of program, in from III effective our of believe decreasing liver. have like the body's the that, from revealed our data the activity. we looked data activity first when we've that now studies, shown CX, we of blocking The from basically, CX the in combination essentially Phase it we portion the excitement show way PNH in activity. the all CX best-in-class is approach, eye, most as which that active we So is our is coming

you it the you and all block and have effects concerns to suffer at so if then from if the block eye. in source, you block it So don't from And that having it it block side the to you the the forth in then at don't source, have you eye.

to have block don't treat eye. in So you it where you it's from, then coming the local

You the effects. local avoid side can

comes forth. increased The with risks and it so systemic infections with blockade concern is of

to our that, suffer from certainly so class forth, only a have but who that population whole are immunosuppressed at patients with will when Because of to agent, myasthenia infections CX. we the on, the gravis PNH this know that serious with believe with and agents, that risk which and in we're that settings. an suffers to not with need come you for may might to working patients GA. we identify those strategy, up can certainly try be So who from example, mitigate We we approach elderly in for block systemic

this all in are can it coming eye, the source a eye with much side patients more by avoiding blindness. terms it at fact associated you the effective way with and than risk. But effects So trying we you make retinal in the selecting are highest at to efficacy, should of get block the in part who out that indirectly sudden mitigate that, serious horrific of probably the is the up permanent which vasculitis, the local in while to including block it

Ryan Crowe

Thanks, George.

I think X we questions. more have time for

Operator

from next comes the Our with of question Leerink Risinger David line Partners.

David Risinger

offer and Yes. And and first, I both Bob wishes best to congrats well to as you, my wanted Chris.

a for best-in-class and patients. results incumbents. the So I linvoseltamab, a more generated to profile have attractive please. It's Regeneron commercial question clearly on But displace has

So convert could you plans linvoseltamab? to prescribers your discuss to

Marion McCourt

will, of course, answer, to anxious go but I'm first. Len

Leonard Schleifer

I No, to David. just wanted give a history, little

were You actually around.

I'm starting exact by Lucentis the may potentially front. really that you we not have good is sure. can done and question, strong to as described, the commercial when execution with we launching Roche. one be that displace molecule, the asked be are there at a in lessons even You and it EYLEA best-in-class then were had behemoth with There some

and that what We've put XXX-pound perspective the gorilla there. a I gorilla. them hope put any of that done comments. perhaps historical Marion, loss to afraid in weight program on want and not do, show to out We're there it. just we can get We

Marion McCourt

you've starts in seen then, recently, Thank more And anti-VEGF marketplace. comment bit bringing you, therapeutic both short. question. I'm be with category the to and going David, say best-in-class categories, launch be always across science. products the for the competitive my great certainly, it But a about the I'll areas was redundant, to into into It's so the And molecule. us

this So we opportunity. to forward do look

oncology very our be look certainly, and will team, we with -- forward with be will And beautifully onc/hem team. linvo. launch patients that for quite helping our ready onc fits it And to

Ryan Crowe

last please. Len Thanks, Shannon, and Okay. Marion. question,

Operator

Our Gould with the last Barclays. line question of comes from Carter

Carter L. Gould

kind about access Was think path move on of the therapies? maybe of this sort have should that the about already I'll How going of further forward about And that best the prior implications that rights of we really does and then kind sort to of cellular the just about change and manufacturing echo of comments as more getting protecting Bob, or of Len all around think facility? willingness your to that down luck. Maybe this? on, development we your partnered George. you assets deal, business Xseventy

Leonard Schleifer

I'll everything on pretty let which George comment do. scientific we much rationale, the drives

view, in mention them, Xseventy long-standing development still Just business to of a we We've point frankly, have from part been were equity in they in of partner and, development. bluebird. when with a invested both

in. comment this fitting something George was can this known. see how that was So well we

George Yancopoulos

little history has particular, about of we T immunotherapy, even harder really Yes. the and have many biologics And We're thus about what programs. collaboration, opportunities separate as as forward is even far, But though separate together to about move expedited the I that most was in were an biologics And excited the fashion that is cancer a existing incredible space. with we is combination combine diseases, what we're the approaches. from this even the therapy portfolio approaches. but excited in that of the we to been believe companies, together think cell the space know working largest we setting it exciting of in CAR more in

led has else that. that. really really else tried has Nobody Nobody

will really together have now that Now this of Xseventy set brings expertise, of capabilities, new to combining opportunity all of we field. cell immunotherapy whole the portfolio their with That try in level combinations combination believe cancer. against our the that with colleagues to approaches and is, biologics we from that capabilities we're their large first really selected a the our and new therapy new space in immunotherapy

that believe what to working in we're for else do be and we've X And programs more. existing just that to really somebody we here. us moving that's what years cell copy addition will the or we're excited been We therapy capability tries until alone them doing in on forward about,

Ryan Crowe

everyone Len not today dialed those to in in Thanks, for did apologize interest we All and to hear queue to that We have and right. remaining the from. chance in your who thanks George, Regeneron. a

a As the once you Regeneron to remaining is you Relations answer and again, always, have. Investor have team at Thank available day. here questions great any may

Operator

you conference participation. your today's for Thank concludes call. This

disconnect. now may You

Regeneron Pharmaceuticals (REGN) 2 Feb 242023 Q4 Earnings call transcript