Earnings call transcript Q4 2022

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Operator

Welcome to the Regeneron Pharmaceuticals’ Fourth Quarter 2022 Earnings Conference Call. My name is Shannon and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. the to turn President, Crowe, now Relations. Investor will call Ryan over Vice I

begin. may You

Ryan Crowe

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

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

cause made to to call forecast businesses, its statements may financial I remind today’s related forward-looking about limited remarks not Regeneron development and related are guidance, that you to, Regeneron. on statements like those and include, Such programs include and materially may regulatory collaborations, and would products in but to other and results statement. issues, reimbursement property, intellectual Each milestones, coverage that and differ projected matters, litigation anticipated and uncertainties could and statement to is pending competition. risks from forward-looking subject those proceedings payer actual that finances,

a new future does the on which obligation not otherwise. whether year the the forward-looking we Monday, any A with Regeneron for Securities States United result including these information, found other and undertake update February Form expect description Exchange XX-K in any more of and XX, for complete to Regeneron’s or X. December material risks filings XXXX its as to events be SEC file Commission with statements ended can

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

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

Leonard Schleifer

everybody Good of I you are staying freeze, you hope the for experiencing optic morning warm. to those and

year Our quarter better by deliver Regeneron, performance highlighted fourth value. strong growth kept position remarkable achievements and of company that significant shareholder sustainable to the

Ronapreve diversity and XXXX increased strength revenue Fourth compared of year the impact prior the business. quarter and when to of underscoring commercial increasing XX% contributions from excluding our the REGEN-COV

year. for this the our of us as pipeline well of in for edema, We also a submission made wet or notably Biologic a August DME, or launch neovascular macular diabetic quarter, during macular License milligrams important advances late in as across the AMD U.S. several age-related Application aflibercept degeneration potential positioning X

with as Additionally, setting, cancer, we only received lung PD-X PD-LX or in Libtayo level. this FDA combination histology of the in first a approval Libtayo making line advanced expressions chemotherapy or treatment for for antibody approved patient’s cell PD-LX the regardless second non-small

in antibody rapidly in bispecific presented x pipeline, our non-small myeloma. lung odronextamab, including BCMA in cell from linvoseltamab, multiple B-cell advancing and in cancer, also CDX LAG-X bispecific our with combination We oncology our lymphomas data Libtayo our fianlimab, advanced CDXXxCDX

was prurigo Finally, in approved nodularis Dupixent Europe. for

company the accomplish in ended three we that to long-term to XXXX, we order imperatives on reflecting for felt had Briefly the we year with growth. strategic position

DME these has aflibercept care X standard our prolonged the by AMD results new outlook change milligrams for this with and medium franchise. had positive patients, for category. in to paradigm September on the XXXX, in potential retinal Regeneron leadership we long-term we the to wet patients the for believe of we fortify the treatment reported First, that Based and positioning becoming for

asthma populations, which younger Type in population X over net position these atopic XXXX bringing expanded at leading product globally. billion approximately shortly. the total of and approved and patients maintain growing indications, dermatitis, and currency. was to a million turned year patients, a increase Dupixent to constant be Collectively, out grow in to also geographies Dupixent $X.X to approvals leadership allergic new needed a and approaching phenomenal polyps commercial new nasal the Despite detail global X market population maintained George addressable and we diseases. opportunity, Second, XXX,XXX will the allowing sales XXXX Dupixent DUPIXENT meaningfully XX% addressable variety with across competition, by

bispecifics. a oncology pipeline, out including Key necessary with to Regeneron, full immunooncology third, enables combination of which therapy. the Sanofi’s and And this also potential be costimulatory rights in make our this our towards our to of promising antibody clinical and commercial It year. XXXX unlock share from was a goal becoming turned to realizing leader an by a foundational requiring global long-term step LAG-X candidates to and to CDX we opportunities wanted discovered us crucial towards in Libtayo, bispecifics antibody, significant progress was our

we of across Looking imperatives incremental business. with well year our ahead, these expect as notable as to another significant in progress be XXXX other areas

the milligrams DME. for potential of X there longer X over milligrams, is and launch comparable plus time and to aflibercept opportunity XX-week treatment demonstrated AMD the but data U.S. We for for decade become a we prescribers milligrams care safety experience X intervals, for with wet with And aflibercept new given EYLEA. August believe to efficacy now which that an for EYLEA, preparing in standard are late with aflibercept

Dupixent based In reach diseases, geographies to interleukin-XX. differentiated expect across blocking and have eligible the We approvals regulatory of X new continue populations in to another approximately younger could patients interleukin-X both we with biologic globally an potential strengthen that population. diseases patients more opportunity its XXXX, its position even leadership mechanism XXX,XXX to and add to approved Type on allergic

year. forward of this to of we Dupixent our of first in X first Additionally, readout the Phase in upcoming half look COPD the study

rapidly to pipeline. continue expect we advancing oncology, our In

melanoma we expansion potentially and tumors. For forward solid cancer lung our to with Libtayo, combination LAG-X are include beyond other with moving

bispecifics, cancer. in costimulatory expansion combination X/X Libtayo, dose we our are Phase PSMAxCDXX For advanced with our prostate continuing in in program

from report clinical Phase additional ovarian our program for X and data solid tumors to expect present cancer. in recurrent data in also We program our initial MUCXXxCDXX to EGFRxCDXX

And require follicular within myeloma. large we XXXX, second clinical of move lymphoma and the we anticipate later clinical Heme-Onc, patients submissions well millions believe odronextamab manufacturing year. In we development have response this multiple regulatory our clinical for alternatives. Activities plan lymphoma to a help diffuse rapidly unable limvolseltumab vaccination to we antibody, who to protect sufficient enter from vulnerable who development were refractory next-generation those in map of and as which other enabling B-cell forward treat and expect commenced with half as immune in COVID-XX also could

pivotal Regeneron and making progress year to in a closing, In significant XXXX we XXXX. continue at expect was

confident generated Our has through of currently remain strategy on our remains and with return. high our focused long-term investing historically We a R&D prospects candidates clinical growth trials. capabilities pipeline rate near XX in progressing which in internal approximately

continue to financial delivering well opportunities by our breakthroughs commercial to also internal for and exploring strong efforts value revenue shareholders. is for positioned to and Regeneron looking will complement capabilities our to extremely potential growth drive position, continue these We continue patients collaborations. With

Now, I George. will over turn call to the

George Yancopoulos

pivotal who XXXX. through walk trials safety AMD X ahead intervals or pivotal pipeline’s like without to every with any aflibercept that dosing In achieved seen XX compromising to – progress improvement are unprecedented not we majority have positive the for have DME. These or using weeks and XX through wet which agents. vast I the for milligram upon and results truly not X visual presented other what XXXX in our milligram game-changing anti-VEGF showed weeks even – ophthalmology, results XX touch in you of potentially briefly patients and Len. been aflibercept would in EYLEA. Thanks, lies extended These

the became European treatment Moving as United Dupixent, biologic only for in X of dermatitis, first infants And week, young to for nodularis atopic the esophagitis. treatment for well. XXXX, just esophagitis eosinophilic for as this months we approval in eosinophilic age, the Dupixent approved in obtained prurigo the the Commission first States and as

for spontaneous Phase submitted data supplemental urticaria we shared addition, esophagitis. and BLA children in a eosinophilic In X with the chronic positive

inflammation, X are Because that patients IL-XX in shows inflammation. approved many related to X holistically Type data conditions. they potential from diseases has X several our now these approved. multiple by Type systemic address often driven from and And Type suffer these X is of suffer IL-X X the these Dupixent thus, mediated conditions diseases Type And Dupixent patients Dupixent is concurrently. which allergic for

associated worrisome warnings, are boxed profile and supports with immunosuppression While other in approval carry infants. immunomodulators its Dupixent’s many safety

looking pulmonary we initial are to first in disease, patients forward the Phase study COPD. In BOREAS, Dupixent results of the with chronic obstructive X or XXXX,

for which patients inflammation. the of study COPD interim in Phase NOTUS X Phase with enrolled futility study. elevated eosinophils by blood aiming select an COPD triggered Type Dupixent The patients replicate studies Our an to the X XXXX, driven have BOREAS encouraging event, passed analysis start X with

We endpoint readout primary COPD and expected exacerbations in with of of forward annualized ‘XX. are the first to of the severe of the BOREAS looking acute, moderate rate half

data. cancer, oncology, XXXX levels, first-line with cell an important PD-LX Libtayo as or the chemotherapy by combination PD-X FDA histology essential irrespective met several combination are an agent. as pipeline an backbone PD-LX year Libtayo of Moving Libtayo in oncology in achievement our lung to emerging programs. in oncology only yield also starting other was targeting on with to encouraging non-small was is expression one by for our approved programs of or

best-in-class are where non-small our as study initial discuss Phase combination lung programs and in results PD-X studies in enrolling smaller These a from cancer both potentially combination suggest metastatic have advanced already from cancer. in a shown fianlimab we as as Phase X positive cohort the reported melanoma in plans and cell LAG-X And as patients. adjuvant melanoma profile initiate another melanoma in second Libtayo, X/X will and we and well encouraging melanoma in melanoma. lung confirmatory Libtayo studies patients antibody, perioperative Phase cancer. to with broad first-line that of we soon data recently well non-small-cell perioperative naive lung fianlimab X are metastatic I has First, advancing have results in melanoma a pivotal dataset

largely CDXX is PSMA notable in very end cold of demonstrating metastatic our other with cancer PSMA unresponsive Phase new of castrate-resistant costimulatory cold cancer, we bispecifics well of in used confer therapy responsiveness patients this combining PSA. class tumor types with the prostate and was first the to to observed prostate immunologically than highest our that proof-of-concept failures our within thought levels from anti-PD-X at type to but treated tumors multiple evidence year Libtayo bispecific, of advanced other anti-PD-X therapy combination Other costimulatory combination. weeks as X the profound be CDXX previously data initiating In in encouraging therapy out X reductions can to as by this bispecific that by the dose greater early XX% a X combination considered prostate biomarker X chemo anti-PD-X in cancer with study of recent unresponsive with showing

these are planning Following in XXXX. but continuing early to enroll to on meetings at present results, this we up medical we in patients and data exciting study are additional

our solid data We tumor first development cancer. our for CDX ubamatamab, also for a clinical in a bispecific in presented for advanced bispecific ovarian MUCXXxCDX

with As in tumors. a of response recurrent response high X% in dose expressing patients with rates escalation pretreated agent subset single patients, small a Phase a we a cancer observed rate ovarian in X a heavily MUCXX study overall XX%

MUCXXxCDXX as escalation well later for with advanced Libtayo bispecific We with costimulatory expect dose Libtayo cancer. initial our this data as in for year ovarian ubamatamab

also EGFRxCDXX bispecific solid costimulatory updated in tumors in this for combination with various data We Libtayo year. clinical our expect later

Society odronextamab, Moving from American presented the on hematology pipeline, Hematology, as oncology we linvoseltamab new our of at ASH well BCMAxCDX our bispecific. Meeting, as data Annual CDXXxCDX or our bispecific to

best-in-class presented we has in relapsed or responders responding a lymphoma and pivotal of XX% profile or line ELM-X patients complete odronextamab, data. potential with recurrent X XX% achieving durability. these efficacy third For response later with of follicular Odronextamab Phase a encouraging

diffuse recurrent to odronextamab profile and third odronextamab’s similar the that safety – prior dosing B-cell optimized relapse demonstrated later profile step-up seen has dosing improved retaining experience safety regimen. efficacy to CAR-T while Our In large in prior of lymphoma, efficacy generally in follicular regardless similar a or or regimen lymphoma.

therapy. the studies initiating we In These second follicular Phase for and in lymphoma planning which B-cell indications, are of anticipate lymphoma, could diffuse in approvals. hope submissions regulatory large in confirmatory will earlier support support accelerated including serve XXXX both we of several to will X conversion XXXX, potential which full potentially half approval. studies We trials lines as

we odronextamab CDXXxCDXX also benefit initiate We lymphoma, patients. combination study expect hope the large bispecific anticancer for with which in B-cell proof-of-concept of could these further to in to a our diffuse costimulatory add

from these study presented disease antibody deep second patients our in the observed line follow-up. BCMAxCDX we safety XXXX, responses on were longer or pivotal year. improve initiate durable multiple in For line and of with later with and X a plan data myeloma linvoseltamab, in a third and linvoseltamab second are efficacy Phase track at Early, multiple Phase in bispecific responses ASH. and for our X high BLA burden of In submission confirmatory may half to study the myeloma we

like As with initiate clinical bispecifics update the near some costimulatory odronextamab, for I’d with plan additional to we programs. studies also combination to linvoseltamab in future.

Our mechanism NPRX are heart anticoagulation receptor trials. for the antibody completing that for activates blocking and XI Factor antibody of proof our failure both

are we treatments NASH, and Regeneron Moving planning Alnylam our Genetics multi-pronged steatohepatitis. with broad develop to a Therapeutics, siRNA on nonalcoholic Medicine, regarding for to approach collaboration and

Phase with a of study are patients NASH risk ALN-HSD We initiating and factors. X genetic

the first and dosed with another a appropriate be targets medicine development in patients. first-in-human also combined NASH, siRNA for potentially study ALN-PNP, can of different subjects We ALN-HSD which in gene in

We have using B, including validated candidate the potentially therapeutic next Regeneron which NASH to side will the be discovered additional Genetics enter our which we clinic. have targets, NASH Center,

collaboration escalation our system Alnylam to nervous central is targets, dose initial ongoing. regard for with With our study

deliver over collaboration CRISPR-based Our Phase continuing building data XXXX, amyloidosis XX% patients, and in in to demonstration cardiomyopathy can is gene therapeutics, expected the which technologies both and in first to CRISPR-based the in that humans neuropathy reduction for a pathological progress up Intellia from on X readouts the NTLA-XXXX product this of of provided study transthyretin year. further with

first the Regarding therapy restore trial with Decibel individuals and MHRA is study patients initial to from the announced in a to gene patients age data FDA collaborators at otoferlin-related our expected to first XXXX. X both younger hearing A quarter Phase loss. U.S. in a virally UK first initiate the X/X our the designed has gene with that and therapy for efforts, of Therapeutics delivered of recently half authorized anticipated the in XXXX years of DB-OTO, clinical been of hearing cohort by

conclude efforts. to with COVID-XX next-generation our like I’d

driving year, of in looking the initiate variants. due domain, selective to RBD also emergence this the identified plan which, so-called neutralizing and treatment This resistant this outside which announced, to antibodies domain, potent natural against RBD the clinical other the COVID-XX that retain pressure broadly outside results activity we infection a As recently all face of we this setting. its spike binding both protein. antibody to neutralizing unlike to find this or receptor antibody, activity are the will have RBD, of retains target it across binds greater conserved, antibody conservative vaccination variance. antiviral to future variants throughout test the that pandemic trials of we the in The and atop result hope as remained of these all vast to overwhelming has variants. known seen unique antibody develop targeting and We of it in antibodies generated majority prophylactic by viral an or the a highly because than XX.X% We of

conclusion, its continues pipeline. R&D the including In Regeneron’s productivity, engine early-stage

that the of as we in for are XX have for indications initiated candidates studies trials anticipate year additional the first starting new year, this clinical for in or candidates we candidates weeks for Just to well drug two IND clinical therapeutic new clinic. and up as submission this already

over So I to will Marion. with it that, turn

Marion McCourt

We coupled existing expected to Thanks, across George. potential growth, Starting year of forward strong The fourth for to new we with which, quarter beyond. opportunities execution representing net where quarter of capped January, growth. in fourth additional year. for a X% total full growth commercial billion, year with outpacing the EYLEA, and providing of important expanded drive XXXX look and We several business, approvals delivering portfolio. our is $X.X billion, year, our category this growth sales announced anti-VEGF $X.X off in into meaningful net were launches indications, and subsequent growth U.S. and XXXX sales the year-over-year results

the where levels negatively in quarter of the approaching XX% category shift At temporary followed quarter, compounded of was short-term of in EYLEA fourth use the share EYLEA by was off-label a of injections. impacted the previous increase earlier Avastin. end This approximately

there assistance time, the co-pay not-for-profit a was patient quarter. opened this fund, During of later which closure in a we short-term

we issue have believe from in encountered the recovered substantially We quarter. the fourth

the but the shift clinical EYLEA confident to profile summary, continue remain expect of current paradigm. approved, a franchise we standard offering as X-milligram in competitive that differentiated retinal potential pressures as X-milligram, the our anti-VEGF We if with to upcoming forward overall leads Regeneron’s can aflibercept franchise In our treatment potentially and aflibercept retinal care look category launch.

were in continue in Libtayo. with In our steady on million continues currency following prescribers. to In last net Libtayo across we to a chemotherapy non-melanoma sales ordering sales PD-X November. Total fourth U.S., In $XXX lung cancers, XX% Turning constant growth leadership skin to combination the accelerated class. the net all growing basis. XX% build million, quarter position indications. advanced global Customer $XXX utilization approval grew cancer, the has to in contributions see

working are by breath depth prescribers. of increasing uptake to We launch maximize and

U.S., Early alone are important as are demand community role is steady we driven an more for in indicators an the per lung year which academic basis than and globally. net important cancer. in cancer the launches sales option. non-small welcomed access reimbursement XX% Libtayo expanded secure Libtayo cell treatment and treatment by million launch to XXX,XXX $XX a currency growth on as positive Libtayo’s grew Outside and There additional of constant U.S. cases have new option advanced lung centers

for opportunities Libtayo We markets. approach commercial and to in global potential footprint extend to a our targeted medicines. future maximize designed continue international priority

esophagitis a to expand drive asthma, the grew and penetration well sales growth net polyps with $X.XX basis new to potential the in where quarter, sales and XX% fourth DUPIXENT, prurigo growth nasal dermatitis, billion. beyond. DUPIXENT from contributions atopic additional market across and in launches revenue billion, established with recent $X.XX to global U.S., to constant is grew and currency turning on strong eosinophilic net indications positioned the continuing XX% Finally, XXXX in future nodularis. across In

prurigo indication differentiated Atopic disease. adoption to younger DUPIXENT in nodularis the is DUPIXENT’s with groups, age for seen meaningful this DUPIXENT disease. to grow confirming dermatitis medicine continues populations, systemic We’ve further debilitating DUPIXENT’s establishing and rapid for profile. as therapy all in preferred where to continues moderate uptake safety be severe rapidly also efficacy There the patients only FDA-approved firmly early across largest

the and We as expect patients asthma of to prescriptions market perform and well identify space with competitive drive patients share patient the polyps, highly ongoing option uptake DUPIXENT DUPIXENT systemic profile first-line in uptake launch strong steady need. leading gains continues to clinical progresses and biologic in requiring new In physicians nasal in continues treatment therapy. differentiated growth total the starts. DUPIXENT’s as

In mechanism with life is to rapid esophagitis, well treatment their experienced eosinophilic the manage of uptake across we’ve the a and allergists. exceptionally seen the and offering dramatic of their launch DUPIXEN have improvements patients disease. going the symptoms Patients quality treated effectively in gastroenterologists finally and physicians underlying both

to there unmet also substantial is need. advance patients We younger continue where in efforts clinical our also

by week, approved in $XXX December. and prurigo nodularis this DUPIXENT was basis, a In new net esophagitis. XX% the approved for Outside indications constant also growing across DUPIXENT And sales earlier geographies. approved driven Europe, for U.S., on eosinophilic in million, worth launches rapid was DUPIXENT uptake currency

ongoing to to indications contribute expect international We growth. new DUPIXENT’s these

patients. XXXX, medicines summary, In to to our core on we deliver executed focus during life-changing

the Our of and market potential penetration our launches. are upcoming increases commercial for in-line and initiatives brands new optimizing and in driving strategies

deliver are to Regeneron’s we together, and long-term are in sustainable growth. and Taken future well positioned confident

Bob. turn I’ll Now to call the

Bob Landry

will on with quarter otherwise you, across financial outlook Marion. be continued Regeneron’s My basis, XXXX the with on results ended positive comments results a noted. business. fourth a strong driving and non-GAAP Regeneron Thank unless today execution

core revenues net net Fourth per Excluding driven increased of growth contributions $X quarter diluted $XX.XX brands. share billion. on income was from REGEN-COV billion, income total across and to Ronapreve, quarter by year-over-year our $X.X fourth XX%

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

was grew Total $XXX Sanofi fourth collaboration DUPIXENT. and XX%, in the quarter driven million revenue by

$XXX profits of the Our of share from and an million, prior of increase versus commercialization the was DUPIXENT XX% KEVZARA year.

antibody a $XX of quarter collaboration XXXX basis. milestone fourth a on recognized XX-month of sales-based ex-U.S. billion million also achievement due the of $X.X We of to in rolling products sales

we million sales our of of Roche a from Ronapreve fourth $XXX for ex-U.S. signed collaboration profits quarter Finally, of gross in share related recorded previously contract. to revenue the

share all year-over-year R&D XX% expense company’s Moving XXXX for with operating R&D incurred impact and to our R&D increasing and full well quarter as now in to increased of additional Regeneron million, higher odronextamab, spend pipeline the for as late-stage costs the antibody driven and our costs. by Libtayo $XXX the connection activities expense now DUPIXENT expenses. collaboration XX% headcount-related Fourth of with Libtayo manufacturing transaction and recording clinical

million by $XXX headcount global support Libtayo to year-over-year costs XX% not-for-profit fully systems and Libtayo increased to Product share to margin improved pay independent to an expense a gross gross quarter favorable related product contributions year. mix increased XX% for profits. change and driven organization. and as U.S. incremental prior in Sanofi gross costs, of higher margin due to the the no was the patient in SG&A compared of commercialization having The higher to in to XX% their longer

rate in tax to year. XXXX compared fourth was XX.X% Finally, effective prior quarter the XX.X%

Shifting sheet. and the now to cash flow balance

XXXX. ended year XXXX, debt payment less and We securities marketable in with favorably $XX.X of free quarter the flow, cash from quarter REGEN-COV government in impacted XXXX the billion. sales recorded for our U.S. fourth that full For first billion were by $X.X XXXX of Regeneron cash generated

development we of the the exclusive by towards billion acquisitions Checkmate approximately fund Pharmaceuticals to deliver in Libtayo. in while and to worldwide continuing rights priorities business billion to share deploying including $X.X In repurchases approximately allocation XXXX, continue executed efforts. development business We capital our in internal initiatives, on XXXX $X.X our R&D

$XXX a reflecting purchased approximately levels, and share capital our million billion shareholders. including new in billion of directly this to current in our remain our in XXXX, us our $X.X continue shares confidence $X quarter. This pipeline. morning, enables continued We buyers announced shares also authorization and fourth new our the we returning business We repurchase to of at authorization

with like guidance financial conclude for initial to and outlook our I’d XXXX.

expect build-out to impact international our in commercial billion. XXXX $X.XX We tile SG&A global growing spend higher of be of the $X.X primarily This headcount the to year markets billion our commercialization and support the reflects full organization. expenses, of range Life infrastructure in select to

our expect to in billion. We to $X.XXX range $X.XXX the R&D XXXX of expense billion be

melanoma As George lung our in mentioned, studies strategically in X and linvoseltamab DLBCL development fianlimab, XXXX, advancing myeloma. we late-stage in numerous FL important in confirmatory for including Phase cancer Libtayo both studies have and combination odronextamab, for programs in and

transaction, This full to advance range multiple includes continue long-term with Intellia pipeline also growth. expenses now the Libtayo itepekimab. impact us development in full for are recording positioning in we XX% for the as collaborators our expenses addition, programs and development Alnylam our In across year Libtayo of early recognizing therapeutic we share DUPIXENT including such all areas for of

improve to Regeneron that drug process to designed to million $XXX developed to new reflecting DUPIXENT XXXX the million, COCM in $XXX of of phase-in substance gradual yields. is the is range expected be a similar manufacturing for

well ongoing will facility of of Tarrytown, the capital expansion fill/finish of support in in These facilities, the continued be We including York manufacturing as million. a expect as our the range facilities our million of XXXX construction headquarters. New to our R&D at expenditures to previously expansion announced expenditures $XXX $XXX

tax XX% in XX%. of margin gross between range XXXX to be be to to anticipate XX% we our Finally, to rate XX% the effective and

we to expense. given as interest XXXX, income our guidance, our last expect higher favorably will other addition year income In which greater full to impact cash plus interest rates and in balance higher financial compared year,

We be XXXX. to other lower than slightly expect XXXX also revenue

In continued no November, results new XXXX in a deliver we and record to longer and XXXX, absent expect to or robust to Regeneron continued Finally, expense conclusion, are income operating transaction. growth I as are any beyond. said drive in other financial positioned well material we XXXX in beyond in

pass to With will Ryan. now that, call I back the

Ryan Crowe

open that Bob. concludes call remarks. you, go to Instructions] Shannon, please for Shannon, poll like for and Thank now the our Q&A. ahead We’d [Operator questions. prepared

Operator

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

is now open. line Your

Tyler Van Buren

and guys. congratulations results morning Good question. Hey, and for the thanks on the

hear the is the latest in to [indiscernible]. are it despite Roche we switches with respect the marketplace seeing EYLEA on what not you Regarding EYLEA, hearing what to great KOLs. Apparently, from seeing would to are be back [indiscernible] from

there color additional helpful? be any So would

Marion McCourt

Tyler. me strong, be I to reported, growing performance very comment $X.X as competitive certainly, and the a in performance. EYLEA market, Hi, quick let billion and to at Yes, that X% very strong continues on a reminder the year certainly

frequently potential EYLEA launch in some of enthusiastic nAb patients the later – have the in we been and And use coming Certainly, But EYLEA continued incredibly We cases, modest as X-milligram of launch of care. KOLs, you of competition the EYLEA. are bit on conscious give resulted talking to many probably most agents, in this to marketplace. results, a that year. to we they’re first other aflibercept to of switching an including standard update, continue back has hear about this efforts forward year look from is know, us to

Ryan Crowe

Next question, please.

Operator

you. Thank

Our next Matthew Morgan question comes line from Harrison of Stanley. with the

Your now is line open.

Leonard Schleifer

don’t’ Matt, you. hear we

Matthew Harrison

me, could not Sorry, you hear Len?

Leonard Schleifer

now. you hear We

Ryan Crowe

Yes, we can.

Matthew Harrison

Alright. Okay.

Sorry.

But you as COPD talked high the XX%. wondering think about have just So meaningful as that reported and in Other I you’ve bar. sort past, on you clinically if being of in I comment view could a result terms particularly not companies of there. was what

So maybe from you could just this. talk Thanks. about view how meaning clinical you

George Yancopoulos

proves benefit well clinical looking exist will. be both clinically also as in at would hope it meaningful function. lung remember, our analysis futility to but improvement be our deliver we powered trial we believe going to which Well, the patios, we’re positive, as we what And if study

pulmonary the integration particular, So of it asthma, function. lung remind settings itself DUPIXENT distinguished a those immunomodulators sort other in delivering has that benefit pretty in from patients from and receive will both substantial be other in I can in of improvements that measures. you

significant will functions So exacerbations, we it’s benefits lung well hopefully as in exacerbations to hope have not only but in as to provide about important which all improvements patients.

Ryan Crowe

you. Thank

Next question, please.

Operator

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

now open. is line Your

Carter Gould

taking you guys. for much Thank the Hi, question. very

have of do of some a of kind You if much the that. here across be should intrathecal proof we you’re guess, the your how I number this as with would thinking a that effort about as potentially concept expanding APP potential And data of of here about on more And the hear sort opportunity to diseases. a on I or even delivery? thinking CNS a of with of if, really more horizon is love you. how product Thank thoughts kind just to gating former, dramatically factor Alnylam.

George Yancopoulos

thing case. Alnylam system Well, central would as do is time aspect the you if it the to first we this liver now about by in technology say, together, the to actually we what’s been in particularly that the develop tissues, the done could important see were collaboration to for and Alnylam nervous to others of bring hoping allow other to that us

type goal do that it the proof principle challenging it enabler, something we But obviously sort if to we really technology it’s see this is technology, in concept liver, work, the And and effective So here work be of proof like the early in obviously as a to the CNS. things program. liver, on of and the is get establish which can pretty of and we platform are to before. this ever study, to that very be the these of meaning focused potential that anything view this first particularly in chat which – nobody is a looks of APP that outside done first has can

be a platform would this So enabler.

Ryan Crowe

George. Thanks,

question, Next please.

Operator

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

now is line Your open.

Brian Abrams

progress my guys. thanks and the all Congrats Hey, on taking for question.

So strategy December, am coming are your elements aflibercept the and syringe, J-code thinking are just potential focused? curious with and you and segments should initially the of approval this about thinking overall you the I the market cadence where for about how high-dose pre-filled Thanks. considering some launch we introduction maybe be converting like how

Leonard Schleifer

a Give us second.

and strategy. In all on will approval on pricing, can the there to we that. lot we We rollout, seriousness, targeting, are August we etcetera. that’s between call, working all get on will go is our going obviously, in etcetera, on strategy, now the be late a on Roche disconnect our of what so hope on But thought you people

to get label. our have We

it get I not secrets else everything a far we The want vial to too to if We down the syringe. have Marion, give will we point. then will any go. you road, don’t initial pre-filled the know have away ready of the approved, hope launch to and this be with at with and

Marion McCourt

to a highly have and certainly look forward just meantime, But say would in our the absolutely milligrams. in team that EYLEA. in focused And experienced with be ready certainly participation today come, we the we I are commercialization, more the of launch for the market will launch. potential on we very and we to X

Brian Abrams

good. Very

Leonard Schleifer

X then against Obviously, to hope them turned the X we and competition. not real Vabysmo that, that’s compete milligrams, standard the It’s closing hope there of a could for launch But market think I us. has become sort of the care. we is window milligrams, on sideways

year. look to forward to the in lots So, later

Ryan Crowe

Certainly. Thank you.

please. question Next

Operator

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

Your line is now open.

Evan Seigerman

guys. of you that a placebo Maybe versus just Thanks in level the triggered saw speak to for just benefit you the can trial? the additional and the taking Thank the Hi, color efficacy trial interim analysis BOREAS of you. of initiation the any what question, NOTUS to pre-specified Matt’s question. follow-up on

George Yancopoulos

was of that of those be what I function it we improvement, There numbers exacerbations disclosed haven’t to All lung we a a were. and deliver improvement. measures can is say would significant powered combination clinically and

Leonard Schleifer

that blinded remain we analysis interim Evan. And to

please. So, question next

Operator

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

now open. Your is line

Salveen Richter

oncology taking do what the next With the most the for question. for my you. consider meaningful milestones XX regard to the portfolio, Thanks particularly Thank you PSMAxCDXX morning. asset? and Good months here

Leonard Schleifer

studies some get mentioned, Well, in we well as we year, we to some continue later we CDX LAG-X. other costim important as the And as the submissions to move to with later the data planned bispecifics additional for year for in of with patients the our in from bispecifics. get need bispecifics. have And aggressively we we obviously enrolling need have more PSMAxCDXX to

hope the even world. have marketplace make successful, around we – and So more to the in Libtayo we

if or I to lots to add do. know George there? So, anything Marion have don’t else

George Yancopoulos

Yes.

really into was in turnkey the that incredible to as of That course, in to studies co-stimulatory We that were in very obviously, wanted LAG-X like but – settings, in the that sort such want to principle the now us it PD-X We classes each And have antibody, feel was to develop takes as tumor with to and important validate working humans. strategy. are best-in-class we which checkpoint world, this could hem/onc that studies truly fianlimab. antibody, establish animal the that essentially it’s classes in animal solid reproduce exciting that it point, three we as our I our magical settings. us with wanted we position are activity bispecifics in bispecifics our critically we to I to think two class. validate for that are right individual we then, synergize Libtayo, inhibitors, other that introduced in we but because, best-in-class years to agents a of also of get individual we working said, validated. And are agents such

of the our now We data fact those, sort really thing are a PD-X, in can costim about and And And validated LAG-X possibility two have the broadly. that outside more first-line this different we this opportunities. both having franchise exciting excited We checkpoints, growing we platform more from now very with that tumor working solid bispecific combination hem/onc with point are shown that we our have we gets patients bispecifics, settings. like melanoma expanding that Same taken early works, delivered maybe it starting much we in rollout. us it that delivered see our combination. to combining we – the and whole CDX first the are that about now looks talked where to where benefit impressive a lot have get are combining

hem/onc other but costim Len from cancer only we more in data by are bispecific combinations space, solid the in out tumors. not several We their PSMA, that clinic, to obviously, in from be of CDXXxCDX in going prostate these we about now data and clearing in going the are we including excited, of very series about the reporting already to be costim bispecific themselves, we costims, bispecifics on But these by said. combinations, where itself also patients, that talked have more and dose bispecific are rolling escalation our a in our safety settings, BCMAxCDX

year, if work models, the looking both a we the end practice also where early filing going they combination much are how could think study, animal the is line earlier to not continue with delivering bispecifics, yet whole work again, which to initiating about. but agents the leapfrog and they these are we hopefully are the these really those are as medicine the human really in studies. now by but they benefit place changing be of patients, are in more to all for individual these what of just initiating We like importantly, we But only to which costim

Leonard Schleifer

very still still getting Cancer that need because Yes. few in is they tumors which makes I it’s marketplace treatment are don’t people cures And between. because not this tremendous advanced be benefit think and extra want a George’s cures. are far can dynamic overstated. point, serious there like

lung most haven’t cured cancers. cancer serious we haven’t We cured or

leapfrog combining their to because position in ability outcomes tremendous have out use the us world get are sensitive paradigm because the need. improve patients in to the foundational and So, then them there very really doctors to does by is more individual still George’s treatment tremendous, to word treatments and

Ryan Crowe

Shannon. question, Next

Operator

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

Your line is open.

Mohit Bansal

IL-XX for papers. has KOLs Maybe some into some It implication you fibrosis to with my staying well. Thank and as taking COPD, reading question. talking Good. so some seems like

a question COPD-X trial IL-XX you be X-year do be inflammation? think blockade Now, and above on you so enough if of fibrosis effect could see think that? And blocking do beneficial impact is, there would to its on and yes, a the

George Yancopoulos

and may have And far, to preventing up diseases some but that that of of long-term, COPD, that actually we talking that as can But accrue studied the involved in the think experiments results of we to involved talked term also And chronic of these believe that that in things type We cause longer asthmatic points. patients. certainly, do years fibrosis loss the ago in of many and the changes be in remodeling true, in fibrotic function like that blocking to bring may this lung are showing this in up term you that we I and that IL-XX result that continue actually asthma. be exactly longer data, will structural could even Dupixent programs We hope so of you they benefits that produce of do you could long-term prevent are in also show patients really that the so permanent studies of and benefit over terms showed Dupixent believe you will if models. that if in of that, say, remodeling terms we were both COPD. we type and in are of about. that positive, inflammation shorter you you time benefit believe true studies need, interesting the of we in animal some the could decreases type that IL-X the in IL-XX lung it remodeling hoping believe patient in first, end term course, we function the changes much function, we about actually that data and in studies, say, for be same in like in the

take as it say, longer actually will totally pick So, we you to think term probably, that up. that you but studies are right,

Ryan Crowe

Thanks George.

Shannon. question Next

Operator

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

Your line now is open.

Colin Bristow

Thanks. the threshold to? just you a Hi. set hearing you can feels or of more result, of on more certainly are you this us based than Good I sufficiently for that – morning your Europe. primarily like just to to were interim It something else And is are wanted and confidence underpinning BOREAS trying what’s there little sort on enthusiastic push understand for robust feel the out thanks ultimate questions. we what point Is COPD and readout. you the here. the good these about taking

Leonard Schleifer

see situation our are the data Regeneron because matter here. Yes. hope And a doesn’t almost later coming to I we quarter. wouldn’t under-read enterprise, up, is and going data-driven right this we it all over

analysis. We the are interim on that done totally was evaluation blinded to the

set We but bar, it the have a we a of at fraction only was said it reasonable patients.

like So, you compared this to never not inflammatory classic we going confident Type another know this would is turn be disease. something out, X about how to as

side. But have Bottom the selected we the to that you So, have line as have the side, interim forward do. look and well on is this positive eosinophils had who data you analysis. patients we on as negative we the that have you do fact

Ryan Crowe

Thanks Len.

question Next Shannon.

Operator

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

is now line Your open.

Chris Raymond

AAO, Thanks. a are Maybe question impact atrophy market. was potential if a debate there around broader at geographic VEGF the on year, of approved. specialist and practices lot on the retinal intravitreal the Last retinal therapies discussion for

like XX%-some the envelope, could volume, this in And drive some geographic folks the just pretty talking of from back patients. were practices injection about, just sizable atrophy a increase treating

about longer that you up acting? they more duration, longer a in AMD. short-acting in guys some KOLs longer-acting fix move a offer from driver we to to be fashion Is sort something wet have of thinking would Are accelerated for you seeing we potential think guys As to therapies that? this terms dynamic, that heard of that, that about should

Leonard Schleifer

inflammation prefer will less despite I every things primary Yes. aspects, risk put practice like of you detachments, more needle there needle the mean get these or time With be complications a that eye, the in would hemorrhages, driver think is all frequently. of patients eye to I in a serious the that. a

the better benefit of to from they – it’s in caregiver. same perspective, for practice a From the injections doctor’s And have better have patients to the that to come doctors’ the are patients. have patient you have Frequently, needle that a are the as to the offices many the by the in elderly they number get perspective. certainly, for of overwhelmed of These from So, number time office. result. the do a times and certainly is and eye free less with they up get with stapled they do injections, convenient are patient drive injections and the less decision time would more that that same patient. would because at could in end the less if and practice their up the believe could primarily with the are just From for I giving this them. view frequent on the But eye you the free make docs of more point

George Yancopoulos

shouldn’t patients, have for more also there edema a fact which sight prevalent if become actually of well. treatments as lose in become Well will of course, of do that off much treatment the increasing macular we that effect. geographic take they and more accuracy these They much levels side are necessarily

Ryan Crowe

Thanks.

two questions, time more have for Shannon. We

Operator

Our next Schott question line with of comes Chris the JPMorgan. from

Your line is open. now

Chris Schott

for much so question. Thanks Great. the

we given be Just on available few registrational there the still you. you of do guess products, pathways or kind to options most costim dose platform, patients slowly filing I you you expect I the versus about studies that for for are think accelerating the balancing, these efficacy. do right – Thank these safety once guess with could land on needing the as even go need of to

Leonard Schleifer

alternative, and Well, we accelerated no opportunities for to need there that that when are approval. is will in be certainly something medical there move tremendous where believe you

We underway they are new underway, use. want all aware to of the pivotal well phrase FDA that studies I be they think are with guidelines your you is a

not referred these patients if to we and linkage course, possible. were as as we that. cancer reproduce a those to the having There is there of to, in mitigate substantial get been the the adverse of the for safety. benefit. no quickly patients. main mechanism taking but is we late-stage are remember, being efficacy we can efficacy. And safety there tight doing an is the mindful the most you can occurred part, there thus is account. as the we events who But everything But So, extremely issue Remember, are only has That far of that need, in that into patients question prostate saw will that to be that

frankly, go are a not But too reckless. patient’s perspective. So, would short from we fast risk/reward that regulator’s where is we even attractive to think the more makes and be the a answer one doctor’s going and

there We if follow have think laid out. an an for to we But has we is approval accelerated be opportunity careful. approach FDA do new the the

Ryan Crowe

Thanks Shannon. Len. question, please, Last

Operator

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

now Your line is open.

Robyn Karnauskas

you for me Thank Great. squeezing in.

on follow-up a question. prior just So, the

MUCXX, superagonist, CDXX combination safety some expecting versa that the doses the MUCXX the think a you about know So, back data efficacy vice you is follow-up dosing as And a might combination, needs of in is safety regarding just day type about CDXX-CPI that CDXX you how the that, of up concerned your like do Thanks. with CDXX to and initial for great alleviate of combo? the bispecifics? and profile your I and for FDA do what was low are think

George Yancopoulos

of a questions from good there. I lot will start Well, the end in first.

horrific or employ levels just there began to was through is see to the from so the us CDXX to report. thought approach there right And For We new activation the to forth. general tightly the CDXX killed very start dose the made to dose activity limit then FDA, in activated we a five concerns program, with started six of which limiting almost dramatic that was course, concern antitumor where active sure, when this dose they about activators levels tumor where situations very, serious body get as and we a surface previous field. go all for had were said, experience that we we you resulted We over that patients, invented very the escalation conservative why, at where rather the program. which to really were we

demonstrated humans. more hoping as are we had that We in what that holding get true is really show experience we and pre-clinically

Len were some side on unrelated They past. were immune-related really in were tumor the a mechanism a patients, is presumably and that adverse toxicities of much what effects polyclonal of fact, target that’s that to non-specific that T-cell talking the response generating and totally more in the sort tissues seeing. superagonist cross-reacted and on we against we to In CDXX seen about that with the the events are was were

for either What when we see bit to get hoping be individual over on through us Libtayo working and who active have with those these I some the move now getting, as where antitumor how to that I to these programs also Len combined been be in to hope XX point carefully that once mix And as hopefully, combined combination studies stages we remains same MUCXXxCDXX it with the presented through to and dose mean classes years these the will CDX and market save mean more are the validated active would history able to we are escalation we PSMAxDXX cancers. right this now be our of medicine be that to of might practice that the agents safety and what you leapfrog say the and But acceptable exciting will escalation to dose studies. just when going the window. margin. this, saw exciting the individual an of in. that place we or on a can is to MUCXX and we why the agents. the have So, in for synergy we lives, increase see combined, doses seen, for then are at increasingly again, next quickly that said, we are the these field the and aiming with we the things. little and agents seeing now get change that with a extend be is things the do it’s are more And And of start is to with to we satisfactory posters an activity MUCXXxCDX you level you so sort of these lives, the to that when it’s having but far, safety try have that’s more That’s to we and get combining other match hopefully

Ryan Crowe

to queue George. everybody those Thanks your the remaining and in answer and a have the once in all dialed to did the have. apologize not you may today. we who always, Thanks that team time a in have IR is Thank great for any We as for to. to interest That’s Regeneron. get a you day have questions to nice again available And chance weekend. and we

Operator

This concludes Thank call. you participating. for today’s conference

You may now disconnect.

Regeneron Pharmaceuticals (REGN) 3 Feb 232022 Q4 Earnings call transcript