REGN - Earnings call transcript Q1 2021 | Regeneron Pharmaceuticals, Inc.

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Operator

Welcome to the Regeneron Pharmaceuticals First Quarter 2021 Earnings Conference Call. My name is Mary 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, Holko, now Relations. Investor will call Justin over Vice I

begin. may You

Justin Holko

in Mary. this you, to globe. your call. website. to around evening good XXXX quarter be everyone the and conference interest available the for our first you archive Thank Thank morning, will listening Good of afternoon, An Pharmaceuticals, welcome webcast Regeneron and good on

that and call Regeneron. call forward-looking President and and George to, Bob its on and milestones, the Head matters, remarks today programs made Scientific for President business, and statements Yancopoulos, would Such open our those finances, to After new and today. as Executive with and any forecasts Securities regulatory March earlier events whether me related Regeneron a Each XXXX, material pending Q&A. Form are and for I Leonard and ended XX-Q to otherwise. cause Founder, on and that these A United SEC intellectual coverage be Financial issues, from remarks, statements future are Chief McCourt, Joining related projected in include XX, and Schleifer, is you materially any Landry, not also statements, Marion and we the of result those not about Dr. Regeneron's events Chief undertake products Officer; include, forward-looking Co-Founder, and results its President financial President Executive will Chief remind filings Officer; like can but may more Dr. filed description we the other with risks Regeneron call and in Officer. limited actual of or statement. collaborations, development statement prepared to property, obligation today's Executive found Vice reimbursement Vice does guidance, Exchange proceedings other anticipated Commercial; to competition. and payer uncertainties could including complete forward-looking information, subject States litigation update risks Commission, the that to which period differ the of

and to discussed Information In GAAP measures and non-GAAP of that our which reconciliation financial is those of press in regarding addition, a available financial release, please measures today's note accessed GAAP in website. measures our and Dr. Bob With me will our our available to call. results team Len non-GAAP use Investor can further be our call President over be on Executive Chief to questions. Once call and Officer, Landry concludes, Schleifer. will the turn that, answer Relations let be the

Leonard Schleifer

and off that all am for bottom and today's to Justin, you and diseases. from start growth We Regeneron accomplish on of double-digit COVID top the to lines. continues joining fight thank everyone call. strong against the in were immensely suffering a proud in I you, again Thank variety to patients XXXX, a delivering of

deliver performance performance Our growth prior the we business products global to Starting as momentum grew growing differentiated positive reflecting In enter of that U.S., XX%, a with on year. continued with net sales execution $X.X Strong nearly strategy. the launches. XX%, begins EYLEA, billion of continued highlights evolution, for were patients. phase our new our the compared product diversification sales and real durability new value and and

business for years EYLEA confident are a come. Regeneron We key to remain the it growth for in driver and expect will

chronic sales considerable XX%. With rhinosinusitis polyposis. for there of in grew billion. excess remains billion nasal performance We asthma are approached where and The and the annualizing also with believe very Dupixent pleased global of Yet brand room dermatitis, sales is now $X.X market atopic in growth penetration a further $X quarter with XX% potential in the in $XXX and net the as are days still product. pipeline grew realizing we in we the the In reached esophagitis Phase indications full in oncology, trials making global eosinophilic million of as steady several progress Libtayo from early with this COPD, year. such additional sales prior potential X and are unique and of

to FDA we we anticipate Libtayo product for to basal in lung that February, two cell cancer, approvals fuel growth which strategy. in new cell in non-small Importantly, and is oncology this a will carcinoma a of secured new help our period foundation

least, While payers days we able deliver a to encouraging we of outcome these significant Phase and new but from prescribers, X still patients. early treating data infections. COVID-XX seeing in for very and preventing leaders, And launches, thought at aimed REGEN-COV on variety with are indicators leading last signals not our program were

George have in death a that patients cocktail dramatically as infections and given preventative when measure. now outline reduces As shown momentarily, symptomatic non-hospitalized COVID infected or antibody our will we hospitalizations reduces

disease estimated will immunocompromised We it’s people treatments having an is use the the a of protective are despite those States well of X.X of recognize profound for and treatment to Regeneron’s important COVID-XX. numbers millions of well-being immunosuppressed. United and to those and the response, emergency and these the the new as alone the or ongoing globe. actions remain impact our in on are that will COVID significant climate to combating global not for vaccination, Breakthrough large unvaccinated and vaccines as mount in we see rates around ongoing that update industry health It uses, lower vaccinated, a authorization are reflect Thinking responds biopharmaceutical data such who and dose. high in in and prevention U.S. who seeking REGEN-COV, gram at tens need are as longer-term

economic recovery. and In are addition, safe effective treatments vaccines and enabling

biopharmaceutical and as come emerging be These learned that work incentivizes innovation, technologies if the to solutions only receive or drugs. people by treating disease profound and these and decades, preventing the in investments COVID-XX so that All public to healthy over We’ve new of full deployed. also extraordinary invented rapidly these that highlight private made of vaccines actually importance of industry approaches can can effects the a both benefits sectors. that been a result have critical

been the or and it’s of EUA patients advantage economic United being tens the with all that XX% fully is take of collaborating our REGEN-COV by this with charge supply given patients to health a are the has deaths and authorized NIH; evidence by is reduce hospitalization example, COVID-XX of of committed thousands providing not healthcare full is diagnosed projected who case an government has an next drug Regeneron For been charge. overwhelming high if is to endorsed in FDA by where and of. to taken under or an lives Clearly, why months to health could free ample to partners of forward we momentum drug at that our risk is are progress potential accomplished Regeneron all and to patients is in benefits. in come. appropriate internal optimal deployed several and advantage States the and of issue saved year has of pleased the have across free first over ability diverse be three were continued better the death. an that to analysis the REGEN-COV so a look hospitalizations Overall, in months has cost not the months demonstrated cocktail pipeline understand And the for its we to of

George. Now, over I to will turn call the

George Yancopoulos

Len. you, Thank

reduced in COVID-XX treatment, that X.X XX% hospitalization data REGEN-COV still our the and doses. large outpatient the the monoclonal recently REGEN-COV the risk reported by We and I cocktail. outcomes the lower start antibody the setting in gram X.X Phase With death will confirming both with the of trial from with headlines, X gram the

by antibody We monoclonal include are pleased to combinations that a for with or EUA were the NIH outpatients based data, April early guidelines strong the moderate mild recommendation as to on criteria. defined these updated COVID-XX in treat

against of showed recently at in first patients. two-part Despite trial after XX% the convenient Part may We with XX% the a of study formulation. virus. proved symptomatic that achieved in of similar is Chronic antibody it infections. rates prevention healthy unvaccinated thus millions Americans in the recently COVID-XX tens and will infected subcutaneous prevention supportive ongoing battle chronic data Phase In Notably, infections were also critical our A this have these with XX% risk a of prevention that B be from A the reported REGEN-COV infection. with dosing large remain high A Part with to estimated of of cocktail Part setting in preventative week. have volunteers future explored trial, of the the prevented X vaccination, of results REGEN-COV

it is that adequate an millions will addition, estimated Americans mount not of In to vaccines. response

B disease in dose cocktail. X Part this patients administration and or for their transplant was of of For lymphomas, in infected patients that example, diseases subcutaneous organ effective our such who prevention for recently immunocompromised show trial symptomatic be in might reducing leukemias Phase disease therapies chronic cancers the shortening X.X duration. gram immunosuppressant individuals candidates myelomas all the also from antibody and as using autoimmune certain or suffer

BLA X.X EUA existing ease United of FDA. I data indeed current an REGEN-COV where dose upon is to similarly, outside all of subcutaneous need medicines, by that will designed believe additional for anticipated States COVID-XX for emerge formal everyone shortly. for we cocktail the cocktail may use. active darn we rapidly approval remind We have year, current likely the that is our of like certain prevention potential and expanded will include above that concern bringing anticipating some Roche the anticipation is used Last are a allow suggest be to be evidence current data formulation the therefore emerge, against future in the ongoing more include active treatment. based the gram availability to expanding Experimental variants. partner our are would be supportive of even of against to countries the our the the the to to variants We cocktail and variants clinic to that and these variants antibodies to

non-proliferative data that to loss recent to year patients designed yet suffering EYLEA three After conducted our period. of study. treatment W the as many EYLEA. showing by anatomic and can preventative dose been drawing delay between A not Protocol a in by XX and times expect higher A has recent week PANORAMA regimen to and similar we a X analysis of early the the to dosing compared PANORAMA compared from who those end, dose half in benefit appropriate vision differences a to group of years, EYLEA Phase filing retinopathy A testing data, patients through. patients on By X U.S. resulted wet week this the in trial found potentially EYLEA patients reduced in NIH threatening AMD. at XX complications expecting study, similarly second confirmed we of two intervals. Regeneron’s analysis diabetic the X% receiving first From on own treatment Protocol a in are two less we high expand in study vision retinopathy diabetic W reads of lower year. for during protocol dosing follow-up and and the second year trial EYLEA W. interval frequent delayed prolonged are the for X% sponsored in planning results adding Moving EYLEA is label this

not study readily definitive date on be what might dosing weeks. on provide help X While will which and study from intervals drug XX insights Phase Phase will the the testing the out expect to XX X measures, studies, are we

Phase the second in by we XXX Phase enrolled signals. this in any and far, The the haven’t X studies study fully patients are AMD, in half X year. expected be to in of wet DME concerning Importantly, so open-label the dosed safety seen

Dozens in Dupixent key as and itch Dupixent’s to severity ever portfolio. safety quality presentations disease scope patients of old and six of increasing in Moving improvement our overall relief young years efficacy meetings immunology the dermatology in recent including of and inflammation rapid sustained highlight life. and on at as

Importantly, immunosuppressant. Dupixent not is an

an esophagitis has this year. part with The choice have preferred BLA old B moderate date This remain announced inflammatory and October years in similar serious action application fortifies our this support Part and XX XX for type of the of Part eosinophilic will been We positive infections belief physician increased to an the not data EU. We that A we previously asthma. children fully data our submitted of world of seen has enrolled. X X trial multiple risk X trial submitted in the Phase Dupixent Dupixent. with in diseases. of to the In supplement Dupixent of of experience FDA to is data severe mounting quarter, first the in use A

in Type actively In addition, two Phase Dupixent X of are trials enrolling COPD X patients.

and this anti-IL-XX with Itepekimab including smokers may antibody, Our broad complementary enrolling. different with program Itepekimab Phase program Dupixent COPD group patients, believe patients. benefits X in that of is for a our We former trials provide progressing many now those COPD real

that using directly allergy to be replace Turning causes birch weekly the cocktails by Bet of approaches now anti seasonal and X desensitization the multiple These currently of that bind occur to our designed X involves antibodies immediately one are the novel common The act and cumbersome monoclonal allergen. v long-lasting. allergens to and allergies allergy of that injections. inactivate Bet spring. most the inactivates to would antibody bind to cocktails And pollen approach years treat to cocktail in v allergy,

Phase Following and this immediate results and challenge, show Phase a X we allergen X year. effects against long-lasting study later are data expected initiated

Assuming upcoming are during birch season. a pollen second we planning Phase the study, study an success current conduct in to X

single showing prevented allergen Phase asthma Regarding X presented compared Fel cat to function our earlier when of and placebo. cocktail data prevented the for antibody cocktail allergic the similarly Meeting this were upon designed reactions lung dX exposure at in decline cat early allergy, patients year AAAAI administration a antibody

data this X a for this update, in cat is positive trial Following Phase first planned later year. allergy

enthusiastic are and these We new ways to inflammation could to about immunology portfolio diseases. novel represent allergy additions treat groundbreaking that our

for oncology and our early for was our In carcinoma, each first Libtayo strategy. with patients non-small treatment for approved of on cell lung crucial certain being the first-line portfolio. and cell oncology the to Moving cancer Libtayo basal milestones advanced quarter,

upcoming patients. be and In in early in this medical first will Libtayo addition X cervical for submissions benefit, shared data any overall overwhelmingly for meetings a an positive study survival in for are Phase cancer second-line stopped planned regulatory systemic these a treatment year. was These of

for sharing melanoma. anticipate Libtayo an In LAGX program meeting. with of we chemotherapy expanded ASCO we of of Phase cancer second to lung the forward this at in combination Libtayo results our in being the is dataset analysis our survival Additionally, in look Fianlimab, anti year, upcoming half interim Fianlimab combination study. first-line X overall studied

which our Moving hold on x through BCMA bispecific for is and we bispecifics expansion. exclusive to our development CDX dose portfolio. multiple continuing In rights escalation myeloma, dose now

in with We modalities and expect positioned of with lines to Regeneron a mix CDX combination uniquely multiple is match responses, bispecifics. increasing earlier studies we myeloma new multiple initiate of deep and hope are year. observing the this targets, later to already

year. planning clinical-stag costim are early bispecific to We myeloma our add of therapies to option next multiple a investigational

Odronextamab durability. responses demonstrates Moving to CDXXxCDX to our bispecific lymphoma, increasing

hear large submitted of agreed on the have follicular partial thereafter. the are and and Regarding hold should the on lifting hold lymphoma intent Phase near we II the clinical back this resume program, updated quickly trial the protocol with the partial to cohorts of diffused very expected B-cell the FDA pivotal in Enrollment term. lymphoma

and twelve also Additionally, is Odronextamab on within testing paired to later this track costim the will the formulation next year the start bispecific combination months. subcutaneous initiate of

escalation and studies ongoing. year PSMAxCDXX Libtayo we these our the initial escalation data different bispecific In with which MUCXXxCDX bispecifics of sooner. In data aspects not with MUCXX. year with and is has tumor types year two for to are MUCXX a to already and cancer start strategy Regarding initial bispecific indication we first dosed is dose hope and tumor the of next solid we are of costim the Combination target costim in combination potential dose later share CDXX if tumors. MUCXXxCDXX in of for clinically cancer, patients to Dose is study, share hoping testing appropriate treatment will game-changing sooner. ongoing, escalation the our be prostate it our ovarian for the solid targeting or next bispecifics are Libtayo CDX is this

out year, prostate introducing for are the clinic CDX other a planning As seen to currently unresponsive in to running and powerful we potentially toolkit complementary this considered unique on a immunotherapies. later cancer, bispecific programs,

phase efforts Regarding now in in our – now and bispecific is are escalation early and combination in our lung tumors, being patients costim EGFRxCDXX with combination cancer other dosed Libtayo. are solid in dose dosed

We expansion MET elevated has is patients enrolling to the study antibody cell cancers. portfolios including selection x Our of cancer are mutations, gene to believe stage. amplification MET the treat in field exon broad potential the dose our in most in XX treatment of oncology revolutionize we with lung a MET bispecific difficult exciting and that this and/or the expression. the Recall, non-small MET protein gene is diverse, patients

our Regeneron Finally, I the would Genetic genetics like to regarding Center efforts. medicines capabilities highlight in our

addition In three that develop our collaborators to targets validate VelociSuite address discover we working potential to are platforms antibody additional with medicines. the have being and of we able platform, with to that genetics-based new can classes to generate our

First, gene editing.

collaborator results be our Regeneron’s from the gene mid-year investigated identified initial are by the our platform of Intellia. systemic-based host and to Center first collaborations announced CRISPR validate editing these results If awaiting being under We genetic by Intellia. a this eagerly for positive, will targets Genetic approach

about Second, approach similarly its address we platform with Alnylam are complementary excited collaboration our also validated siRNA genetics that targets. can

to XXBXX, by now Our target Genetic Alnylam NASH discovered directed a enrolling the Regeneron is Center ALN-HSD patients. target HSD

series Alnylam of follow-on collaborating and we Additionally, a targets. are

While linear therapeutic nervous approaches, extend the we set to currently to is central technology targets. and system eye validated directed for are

fair medicines and approach of involves Regeneron. genetic interest biogene approach and excitement significant a therapy Our delivered novel at it’s

the targeting year in collaboration of for tissues multiple Our clinic Marion. ear. DB-OTO With Decibel the are would turn with enter the We to the first focusing use with in to I programs planning platform year next other call to gene interest. AAV’s are over addition target Decibel like to we in in and developing that, therapy on the a

Marion McCourt

Thank you, George.

We XXXX. start are off exciting an in to

unbranded based sales and differentiated the is EYLEA XX% comparison and favorable EYLEA commercial and based net launches pandemic indications. recent range we the of be growth our grew sales a profiles. and EYLEA, year-over-year safety, increased continues to grow brands, Beginning demand has the of is combination net share to product billion. in year-over-year flexibility competitive branded is the the three in and branded billion EYLEA weeks differentiated includes category approximately early preferred largest U.S., portfolio EYLEA, EYLEA and by nearly Our first with and XX% the the continue expanded its anti of on XXXX. of category, indication approaching capturing to Libtayo global $X.X to combined to XX% XX% and $X.XX quarter option. In on VEGF grew first In Dupixent category. efficacy, the of quarter treatment dosing

confident In addition, broader new administered with continues disease are category, improve the near based and patient and our in XX more growth preference grows, diabetic physician Across flow outlook physicians on considerable eye clinical XXXX and demand with normalizes real-world EYLIA, our opportunities longer-term we for to have future than injections worldwide. million opportunities patient experience in program. dose patient favorable high as volume demographics, in

first of sales global of Turning quarter net to cell $XX in grew quarter to majority Libtayo, carcinoma where Libtayo one first sales The million. with million systemic net sales vast the treatment. is cutaneous squamous were $XXX U.S. number

on community-based our evidence lung at clinical with uptick and practices. competitive Libtayo proposition. in overall We promotional opportunities indications from cancer, growth are experienced encouraging lung these our we are extend basal and cell compelling is of cancer we and heard highly force non-small across excited BCC, In expanded of have top the oncologists carcinoma academic meaningful value represent based for April, Early impact. that and Libtayo recent In or Libtayo. data the both indicators launch cell which sales approvals strength by our deployed to highly

market We growing are securing formulary overall peer coverage advancing decisions placements, favorable and awareness.

from rating. as for has only in guidelines as rapidly guidelines to suitable on Category category feedback include this with BCC launches Hedgehog Libtayo important to tolerability. inhibitors a Libtayo are are the BCC anti-PDX for to prescribe approved be we routine patients. and Libtayo. advanced an long-term that and care in updated focused Libtayo to a for NCCN first-line in for have patients benefit is use. in encouraging is new its ensuring being disease Libtayo Importantly, efficacy Early been used our been appropriate plan eager NCCN its highly according despite alternative physicians on also may treatment X indication. patients was option, the are BCC the The Libtayo In lung preferred summary, or included progressing and based not

launch EVKEEZA, with treating which and on therapy. recognized now and in multiple to the is Hypercholesterolemia quarter already initial specialists over Familial Homozygous Patient the proved current by steadily initiated also with has novel of effective Turning XXXX improvement standard-of-care. phase. demand is EVKEEZA in is patients a as and patients first treatment represents the an building for

Dupixent’s strong across to first now continued In its million and and sales severe net XX% launches. the eligible remaining in the on global indications growth safety In to prior U.S., based the patient our $X.XX the number profile. representing one year. following all net indication dermatologist There the the prescribed billion, continues and Moving depth than compared to patients. $XXX quarter groups new disease largest breadth pre-COVID based growth starts broad adolescent of and Dupixent, growth prescribing proved across on pediatric generated of for with the long-term moderate based age be is efficacy sales is were atopic among levels. higher across and Dupixent significant need unmet biologic dermatitis,

are we by efforts. this patients year. as the six our to educational of and adults, patients later and age of extensive patient in adolescents preparing driven launch where number Turning years continue young Among asthma, provider to initiations meaningfully expand as we actively pediatric Dupixent to

fastest-growing authorized an in addition, currently for with respiratory and to also of and like the diagnosed close with is substantial indications in first all polyps. quarter, government. strong In factors nasal age REGEN-COV to risk the million under EUA of recorded which with approved room is based growth. the cocktail represent for among highlight In supporting antibody biologic on REGEN-COV. contract E&Ts our we patients adults demand Dupixent net and U.S. sales COVID-XX. $XXX U.S. under first XX% allergists is efforts disease our patients with I’d

with direct REGEN-COV, with of education stakeholders increasing facilities, We availability the medical and Efforts reducing include, to are on focused states rates. third-party support consumers particularly partnering antibody on utilization, for in infection treatments. and educating key high bottlenecks

and be As update as to for preparing those may who who treatment. a to protection. REGEN-COV George of exposure There hope we signals mentioned, are In we the very COVID early also may EUA we requires our rapid potential to candidates able business, robust for unmet from of known summary, delivered care our the millions and quarter strong preventative an substantial the portfolio be be from is Preventative need diversified ongoing recent of across have for for our growth. positive address year. in launches performance inline encouraging first include important prevention momentum opportunity for patients continued

Now I’ll turn Bob. the call to over

Robert Landry

Thanks, and to good results will call. on on a to where non-GAAP comments Marion. everyone My afternoon And today basis financial be the applicable. morning listening outlook and

As XXXX Len strong across the business and continue as a in top the off to start bottom delivering quarter. stated, line to Regeneron is we double-digit in execute growth first

sales growth of Sanofi in first on REGEN-COV net increased driven our profitability $X.XX driven antibody by revenues share Diluted to income income billion, to Dupixent sales; XX% total net and EYLEA per grew XX% year-over-year the global year-over-year For $X.X collaboration grew billion. of $X.X by quarter, cocktail.

revenues year. Excluding growth total to Regeneron prior the REGEN-COV, XX% versus revenue related achieved

contract for the collaboration net by initial a from Bayer government XXXX, currency revenues, of were quarter compared Starting XX% EUA deliver heard to million we to to Total updated million us move $XXX product we completed of was profits of will million supply U.S. $XXX XXXX. to our quarter. $XXX in reported dose a we and treatment secure contract collaboration first Total in $XXX an expect Ex-US prior to government revenue share you’ve to the with the quarter. for reported REGEN-COV million the Marion, assuming at on in quarter basis quarter the the constant of Bayer the compared outside sales the our follow-on XXXX, which in were dose million, growth first basis least EYLEA U.S. the X to of for which X.X at $XXX now Bayer first revenue of in on REGEN-COV gram we from first collaboration, $XXXX our with first that the second million As U.S. quarter collaboration recorded million of the I $XXX Sanofi for year. sales representing EYLEA was the per net XX%

profits by lower the the million we compared quarter, half this to the U.S. first line in to in Other million of the $XX year year. of We the was be Roche of revenue collaboration less to prior XXXX compares $XX for of initial Roche outside from what gross due $XX $XXX driven Kevzara of cocktail profits million of in to the the than border from XXXX, profits in and our share prior Our revenues distribution reimbursements by the Dupixent. million, to In recorded we recorded expect commercialization share and of antibody $XXX which with favorably of Dupixent EBOLA million COVID-XX the programs.

cocktail. Moving to R&D XX% year-over-year development our R&D. on continued clinical costs antibody for $XXX starting expenses, REGEN-COV to our with and million, to increased due operating primarily

due year cost to prior quarter year-over-year REGEN-COV the sold cost of versus increased REGEN-COV roll XX% and to year-over-year $XXX Libtayo, U.S. in Cost which for higher investments from in recorded million the Sanofi expenses. Praluent Next, commercial SG&A $XX manufacturing to of out by employee-related costs manufacturing of increased goods driven The were expense increase million. to by related the the the XXXX. $XXX million and was first in

This driven in Additionally, issuance cash compared on existing income year. to interest the in of expense, and related our other in and $XX $X returns recorded we billion marketable prior investment is debt million income to our lower by expense million expense, operating securities. $X XXXX and August

first first now quarter was by cash the quarter, XXXX this the the I free marketable in rate to to benefit of the tax achieved we of with in uncertain first press year our and Regeneron to position generated ended is in the and complete A billion of the remain authorization flow tax net available is select now IRS buyers our and securities million liabilities would guidance. summary $X.X share In $XXX XX.X% balance Finally, quarter of updates sheet. In market. like release tax guidance in the cash of our XXXX, we audits rate reduction provide latest the years. utilized Shifting XXXX opportunistic the in and this the billion. quarter our cash effective $XXX morning. earlier related to million full XXXX flow XXXX. and of published in a Included repurchase $X.X

lower is range range of COCM We for for are XXXX of $XXX updating guidance Praluent related to of in the be million to Sanofi. manufacturing the million, guidance contract full $XXX the timing year to

to We our under also non-GAAP guidance XX%. in effective by increase tax driven for rate the U.S. government aspects all start execute U.S. guidance in delivery from The contract, of the In is a to REGEN-COV continues to our prior XXXX XX% range of across passed of be forecasted higher updating Regeneron rate. XXXX the is are second at business. is off statutory which strong and to

well With back like are for long-term to XXXX the Justin. of that, call growth. those continue make to ensure We to turn positioned and necessary investments I'd to remainder the

Justin Holko

will Mary. were each and for Q&A. prepared like you, as to the call Bob. now Thank to moving next. ahead, just to many to We'd ensure in open go we With we able Mary address several from one callers remarks. Please that as our possible, the queue that before the concludes question caller answer

Operator

Sachs. Goldman of Flynn [Operator the Instructions] from of Terence first comes question Your line

is Your now open. line

Terence Flynn

Great. about Thanks later have that if How the guess, question. the that maybe, landscape stands the it at are term respect been walk for this JAK where delayed, inhibitors including assuming you you much could think to as the kind Dupixent, headwind and dose. for but us the market competitive right do longer now reached through to the year you so I Thank the adolescent thinking with high of the market penetration And opportunity, setting? guys Dupixent? competitive about a adult in you. taking

Leonard Schleifer

Marion. Go ahead,

Marion McCourt

Sure.

the start demonstrate first, in today. we recent also across JAK the with the that great effects, hematologic atopic multiple me also a seeing importantly, And So, data dermatitis. And safety, experience alternative. risk I with of so Dupixent we including close question in these tolerability, pay very that only case at of into the the clinical safety inhibitors in safety, well is the are and main are the profile. certainly especially we see and is their doses tremendous key off, have at is of hear attention certainly cost marketplace. even is chronic efficacy, a am use they the a categories competitors confidence malignancies, the age are really let Dupixent the it speed these to tolerable of that forward And on of not calling who opinion aware from and therapy but just not indications doses, this our something of patients and and marketplace as continuation coming action, of to leaders warnings, tremendous This higher stay therapy issues which lower into say the delays, we infection Blackrock’s going having the currently for obviously when the

And across and in remind I competitive its forward. Type Dupixent, concomitant of efficacy our mode we So very have disease think other action, profile obviously, confident going Patients has great feel X do sometimes indications. based on that conditions. also

So, and opinion to very leaders this key of confident very, on our the to close very and specialists profile Dupixent. in stay balance, are who we’ll

Leonard Schleifer

concerning, points of treatment just the is Yes, be that, the for I will long-term would I particularly children. one think add two safety

the the as side with side. And ageing almost the in concerns on so, have of what profile that I the – unparallel efficacy frankly safety is Dupixent any has shown on and you do it’s significant think, not safety terms really, can

other amount for is the terms how rheumatoid arthritis have at out you so psoriasis, if low have for of these is direct that, agents in competition rather even it when more on and fighting terms come market a even of look point for evolved, than share. growth of here markets market penetration the The with penetration, there in room fixed

low So, treating we says physicians’ far does room expect level our Marion profile, nonetheless. think we of the minds be penetration safety thus growth leave do to as firm for really and on

Justin Holko

Great.

Next question please.

Operator

Raymond of of Next Piper the line comes question from Chris Sandler.

now open. is line Your

Chris Raymond

Yes. Thanks.

question another Dupixent. maybe on Just

indicate AD necessarily may managed, checks a optimally to a is there Dupixent of and who not lot failing. but interest regard not with our are therapy is be So, of patients lot exactly there that add-on in

guess maybe I or there a is JAK with, looking of atopical lot So, other interest therapy. at some

about at if Dupixent proactively work a maintains maybe looking Thanks. that combo role kind have of core? to you thought as guys some Just just ensure curious sort of its

Leonard Schleifer

to out affected commercially dermatitis, over kind in might you side patients George, of the severe body fractions Well, body. large to interest you in we we of moderate they this fraction it of remember want what to have commercial I when was this, treating large trials, are talk any exactly what comment if that, we are atopic seeing our in patients, are of there disease. but of their their is can the lesions by terms have

And lather topical entire get away actually but think up people perhaps, – that over from their trying away having body. trying so, to to I get to adding from

that in lots run nasal because atopic dermatitis can we or other to diseases and thing very allergic broad tend allergic other atopic many forget and which The and dermatitis of Dupixent who growing aspects are groups. important diseases do studying. that, or are asthma the people number, asthma polyposis these across is we have and diseases There never of it’s the about approvals with

broad think that competitive I give of diseases a also other position. to So, us lots strong is across our going very profile

Justin Holko

question Next please.

Marion McCourt

with research this market market in dermatitis. on add just I very look and with Dupixent for the atopic have Yes, share going level carefully that, real we as a do I - just to patients just obviously this satisfaction and well question, is at that of to very quickly, wanted Marion, experience, to high

make want more an is for patients just I left that not lot for something treated there who impression necessarily to are that sure atopic there of with Dupixent dermatitis. looking So

Justin Holko

please. question Next

Operator

JPMorgan. Next question Kasimov comes Cory from with

line now open. Your is

Cory Kasimov

the for continuing guys. have you dose and wait sense doses Thank emergency good on to ship Hey, to COVID anticipated you a the it? and REGEN-COV wanted are taking high ask you Do Thank for of hurdles remaining the you on low morning my timing question. I front. authorization for you. to antibody cocktail as

Leonard Schleifer

that they exactly we in FDA the discussions when in an anticipate We’ve the and one do it. FDA. But and action weeks Thanks terms X.X gram been to the going question, lower over are Cory. for several do active going with productive they are sometime next knows never by Obviously, of the next discussions to the – Right. what dose.

I of the prevention think from as there, front well have attention opportunities. they well which they as the them chronic data their as subcu data, will prevention to turn the in as

FDA assure really the working you been has So, can hard. I

them with next to contact and something questions, over constant going we as I said, sometime decisions in things are answering We several – the weeks. anticipated expect in

Cory Kasimov

you. Thank Great.

Justin Holko

Next question please.

Leonard Schleifer

market of And supply treated no available. the Cory, can be I to gram X.X treated of there people ample am continuing is sorry, of is product out in terms course, product now are to dose be with the and there we needing and shortage there

Cory Kasimov

Perfect. Thanks.

Operator

Next question Leerink. comes Geoffrey from SVB Porges of

now Your open. line is

Geoffrey Porges

So level is many sustainable current sustainable little things in, last and the well? and in margin Thanks. XX% the been questions and would X, XX% of that to a tax as level at would time. COVID it at ask without to if have the rate such squeeze operating quarters, the But, antibody about current couple the I the what

Robert Landry

tax certainly be I’ll rate. the Yes, talk regards a to what’s I to going there is with on mean, rate. out lot I the tax played to about happen mean,

obviously operating On heard to are not still you the pertains regards transparent enrollment lot regards it margins, with positions which have uncertain we tax outcome our we a the everybody front. that REGEN-COV piece one with know, to as guess, so a incurring Geoff, trials, is, I moving You numbers. we the of R&D the that’s I on are what kind said, able within in of drove full year well favorable reverse, did little are quarter to guidance. We lower that

don’t talk want to of his in good. that underlying at strength operating sales. that where as benefit we of again, Sanofi result business are continue on a little at the don’t a say, momentum leverage shows top-line a REGEN-COV did the pertaining words EBI, been we within from in you as the margin Dupixent, that the know, that is product saw it’s you terrific level. you get of we stay have way our XX% without Len we of on certainly, come mean, at that its ex did as REGEN-COV that incur expenses lot right? U.S. heard to it R&D terms ex a okay? Roche it was I the and that improve how extent – line the to To specifically XX% starting are just to own, job The So, So, people excluding and are sales very terms that would margins about. you’ve beginning the and the We in got I the think U.S. we performing. of But

continue So, will with that will our that we’ll continue that extent the margins. that margins get to to operating overall associated play good out, then to and drive

Geoffrey Porges

Rob. Thanks, Great.

Robert Landry

Geoff. Thanks,

Justin Holko

please. question Next

Operator

Partners. Yatin of Next question from comes Guggenheim Suneja

now Your line open. is

Yatin Suneja

about Thank Thank question. the maybe capabilities? or And we where you how my BD? the Could cash. in taking of should guys. have you about like would you question a there collaborate Hey to you. talk I for on top areas deployment priorities? bring think Are

Leonard Schleifer

Bob?

Robert Landry

Sure.

on make a the balance early-stage. stool or and to most go that’s it and we likely we on the like internally, billion support technology cash everything. other tied again, are a technologies we at modalities CRISPR us. the we BT play get of George gross great are sure $X roughly are on that have that that in net be basis. $X.X always be go the and to don’t to at And continue things flexibility sitting our leg we we I affords to it we continuing of R&D and billion need after that on enough internal after space Our capability which that where for cash And the whether we kind Alnylam to into go have to the obviously different and of second we It’s capability alike. team Intellia-driven heavy to make sure have going and in-house kind out of basis need

stay right buybacks. continue as for then of we hungry place deals front right $XXX we We kind of the did million transformative saw, to opportunities. in of share now and kind that with And on are not you that M&A as looking

a that January. We in authorized $X.X have we billion program

the an active currently buyers to that see and continuing we front. opportunistic that where intrinsic we and playing are compared such in us. market on that value play we advantage think we did are first And are is that we quarter We be where to do take of delta and of that to the the for it going continues to

Yatin Suneja

Okay. Thank you.

Justin Holko

Bob. Thanks,

question please. Next

Operator

comes question from Next [Indiscernible].

now line Your open. is

Unidentified Analyst

Jeff. on Thanks Alex Hey taking for for guys. is This our question.

management EYLEA, the up COVID-XX new years, few fairly AMD. looking Thanks. despite you high-dose wet timing an lifecycle one scrips the data or coming next on there the see But, venue on market holding well to do this, study? primarily Just from formulation? CANDELA on for update entrants and this over obviously, in sales are from and And is a

Leonard Schleifer

Yes.

think and Protocol that results. think W, we in generated data to I with lifecycle important management beat are that more which diabetic reviewed, from very continues the PANORAMA I that the of kind data retinopathy George

I will think And that more that drive so, treatment in area.

that later terms year. the dose, get of into newer In Phase from think I clinic X the for the that we entrants, we then, unveil have readying next this get you version, for if And you will, preliminary we’ll you a George, data which some the we for heard clinic. high will of when

Justin Holko

please. question Next

Operator

Next from of Robyn Truist. comes Karnauskas question

Your line now is open.

Robyn Karnauskas

the prevent you Thanks. What taking product? any from what centers And how I counterdetail for ask the from likely share your this question. might that latest question, is EYLEA? but, on faricimab? to from more the thoughts to am are thanks think you Guys be hearing do utilize counterdetailing taking that scared you specific

Marion McCourt

Sure.

mentioned clinical and still the at So, let stage reviewed. data product being the where is all, obviously, not the of say, you me first approved is

see to on EYLEA. you Certainly, not on of look rate, with some in some to IOIO faricimab, question as we threat mentioned questions I profile some who safety profile. recent today call, were clinical profile an we the the the do a on last increase clinical had As certainly of data the at and of

didn’t is in and see the that indications. with and think and obvious that is there I’ll spoke EYLEA, is some the safety, that treat of leaders extend even clinical therapy first dosing that important hear perhaps durability, EYLEA they on retinal basis an profile trial we benefit mention ability questions performing to and because the one the treat well to that I regular actually to reasons well the mentioned. designed why the clinical in so interval, product so competitive of on across ability and against EYLEA profile performed to key constrain EYLEA’s an was product year of when matching conclusion a attribute extend of EYLEA’s its I of and efficacy frankly opinion is certainly the very in and the net last quarter you community for to confident XXXX We the elements patients. remain in

Justin Holko

Next question please.

Operator

Young Alethia from Fitzgerald. Cantor of comes question Next

open. now Your is line

Alethia Young

quarter. just asthma question Hey, the guys. my Thanks all I XX indications. X progress this a congrats couple on want expansion of and to for the about taking

profile fact you talk robust are could march how the thinking It their there. pretty you be atopic uptake on about the Just of in well. light it feels are and can about safety that as like kids of kind

perspective on get to that thing? wanted your So, just

Marion McCourt

Sure.

and Dupixent patients, do much who this opportunities time, these and as We exacerbations something for age function reduce very and asthma the profile. today young healthy look very from help Dupixent improve safety at patients we You forward Dupixent’s important ability struggling year. and then, and will lives. families be their mentioned the airway for and that in more see the these this up, these their tremendous for to and market It’s children tremendously with launch recognizing normal the same living prepared are and will later really pediatric benefit six a to

before and with So, the associated care asthma at the we same disease. mentioned time, take concomitant of the X as type Len diseases of possibility

and this confirms it look efficacy the will very that launch. of forward a once again So feel important indication we safety Dupixent. and to the be We do

Justin Holko

Marion. Thanks,

please. question Next

Operator

comes Mohit question Bansal of from Next Citigroup.

is now Your open. line

Mohit Bansal

One question dose my Great. on more and Thanks progress. taking the for EYLEA. congrats question on high the

trial, are could a which I would designed that trial is It running. scientifically, be some you this different. back bit some superiority you why that understand question. then, Roche But, us Thank know HARBOR into do your about [Indiscernible] to give is we my of better that would not I mean, that And kind ran confidence you. trial, the that a days, result in is be opinion helpful a high-dose benefit also first there. trial So, in talked little

George Yancopoulos

looking be of basically that think higher the will the the at. thing would That notion simply primary extend dose I duration are we - a that is Yes, action.

So, achieve minimally longer you action go effective obviously, for of will longer dose. you allows because, it the duration until

dosing? that can of is, well notion have the dosing can major dose. the the So, of higher do So, now is, patients, increased numbers XX-week who goal or every XX-week we that’s will every show we testing with

Leonard Schleifer

Yes. the dry, patients, weeks And to completely eight you’re because eight the weekend, in full where drug interval some action, still but, there is was take the extend as but, probably at who George if trying you let’s saying an at every some not that, people isn’t look say, you them even. are an lasting

the And might a manifestation so, as action. more longer see you of drying

longer. slice, is it you’re drugs to to last there having of couple put and looking but, surely, So more ways

Mohit Bansal

helpful. you. Thank Super it. Got

Justin Holko

Next question please.

Operator

question Cowen. Next from Yaron Werber comes of

Your line is now open.

Yaron Werber

Centerra sense now has been into Centerra? some for What growth can in of share pricing. Marion, on give do offset understand we aggressive Great. Dupi that you for asthma? you of some for And physicians what’s a maybe on Thank us that Can to asthma. you. the you very

Marion McCourt

Sure. question. Happy your to take

with I’ll total pleased Dupixent, and are initiations in of say, of terms we scrips. First, the both performance very

by We indications. haven’t given details of share

in today. total comparing asthma very, certainly the very I look going you well So our to comment Dupixent but specificity not only say know Dupixent we as the the away strategies, we value at asthma. are concomitant performing the other shared, as you the from that seeing on what am are scrips, uptake I’ll can and treating company’s we performance compares data and either profile, total with or but and from for that But, diseases. pulmonologists, safety And it when stay the also patients allergists can initiations with IL-Xs see result data very a I this of marketplace. pricing the in to also favorably is, know allergists profile that not is clinical

Justin Holko

question Next please.

Operator

Next Kennen of MacKay question comes from Markets. RBC

Your line now open. is

Kennen MacKay

Marion. on the such growing like One It seems that taking derm much than sales is also Dupixent maybe for in thanks asthma just larger basis. it Hi, But, because seems in question. like a for has faster Dupi AD.

quarter-over-quarter coming So, of Marion, just Dupixent’s wondering asthma from if frame derm? percent is Thank you what growth can versus you.

Marion McCourt

Sure.

all business polyps, total talk patients, in So that, important the need asthma let Dupixent still atopic is and future I very in we both have is disease share you me asthma about respiratory the that nasal of biologic-naive. about about dermatology, the There indications XX% youngest and tremendous then, XX%, atopic Both and in is with dermatitis Dupixent groups, the are can Both of being certainly, as growing long in way larger to very, on we dermatitis the respiratory asthma strongly. potential And before today, growing age that asthma, go. several atopic adolescents the unmet well, at for strongly the launched dermatitis, marketplace. look in to it’s adults. are very, years disease. in of did two marketplace in patients note are we very we XX% across Dupixent And about asthma the course, as the going a that remember

There of these we’re Dupixent the biologics starts. been So, the growers asthma overall is and getting has of tremendous new opportunity marketplace. one

to even well. - adolescents, pediatrics engines are for this George in And the FDA in we opportunity later to among future eosinophilic approval with still in I to an the like - indications the launching related and question, disease forward the in allergy growth in his tremendous in many and year, the but, type that without earlier esophagitis mentioned of to X there’s is As update response look today. forward areas product. look other Both as the to this asthma mentioned launch adults some

Justin Holko

time have we for more questions. two Mary,

We going in them try quickly. squeeze to are to

Operator

Sure.

Baird. of Skorney Brian from comes question Next

Your now line open. is

Unidentified Analyst

Brian question. dialing This taking Thank Skorney. in is for for you our [Indiscernible]

the is we’ve good the with are can Intellia. I that based data for seen just the about ATTR and safety of how partnership your you we on question success on the for vivo approach soon you. terms should CRISPR see your anticipating here in more Our pretty of Thank ex-vivo and but first share in in vivo broadly looking for the indications, this we approach. thoughts Maybe, think not proof-of-concept with the it at street? approach,

Leonard Schleifer

that? you do take George, want

George Yancopoulos

this for be Yes, I important that most is, we’ve Genetic us already said, is to of targets amenable think might is the that we’ve this we have identified Regeneron through Center. platform. as a multiple platform aspect our that And this

And so, out. that work what depending sort does will will of be how and So, we interest it great the profile? will a on the determining this be think and be safety of platform tolerability a it turns result,

Justin Holko

Thanks, George.

for more time one have We question.

Operator

Gould Carter Next question comes from Barclays. of

is open. line Your now

Carter Gould

taking COVID question. the thanks Great. and in the progress and quarter for for all Congratulations on the tackling

you Roche and of sort countries continued – increasingly stockpiling? and efficacy about in approaching and in read appropriate doses of efficiency do post-vaccination given can answering world As in and how And the you terms in clarify an question, you how and guess, any of how you and think stand about Thank healthcare capacity that lower think should kind - into supply are just where systems scale? improvements I you. production think REGEN-COVX we of

Justin Holko

that? to want take do Len, you

Leonard Schleifer

of as to now, do pretty I with different we obviously, the developing better speak States. the pandemic really we that working supply. don’t I are are market of Roche jurisdictions. know United how a It’s a lot is, different lot of But, think is adequate And on a changes position. outside in discussions on comment there they But, the quickly. for

has think anything specific more unless probably I to is So, that, answer be going you. for to positioned Justin Roche better

Justin Holko

Well, callers for queue that. didn’t it. call several everyone thank that we today. joining that’s still in we the to; get have apologize No, the We you for

to Be We the in. safe good a you after and Thanks everyone up day. will follow for with have dialing call.

Operator

the call. you presentation. This conference Thank in participation your for concludes today’s

disconnect. You day. may Good now

Regeneron Pharmaceuticals (REGN) 6 May 212021 Q1 Earnings call transcript