REGN - Earnings call transcript Q1 2022 | Regeneron Pharmaceuticals, Inc.

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Operator

Welcome to the Regeneron Pharmaceuticals first quarter 2022 earnings conference call. My name is Gigi and I’ll 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 Gigi. this website you call to globe. your call. Investor our around evening good Relations earnings XXXX be everyone the welcome conference interest ends. available first for our quarter you archive Thank the Thank morning, will listening shortly Good of after afternoon An and to webcast Regeneron and good on

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

with note the statement at call. website be regarding nor and measures our which an will addition, results use any to This on to Information accessed website. release, concludes, is a IR non-GAAP purchase please Once our those financial of available questions. GAAP our Bob Checkmate and today’s financial offer the measures press Inc. Sub Scandinavian at filed TO XX(b)(X) of will Checkmate reconciliation materials, offer on in In of discussed to Checkmate’s further GAAP an solicitation that non-GAAP are our neither filed available and is In connection with call filed measures a tender as to answer can by be Schedule offer be securities Regeneron at of the and the with charge Inc. Checkmate SEC or Pharmaceuticals SEC for www.sec.gov. of tender SEC’s Regeneron and applicable, other at website investor.regeneron.com ir.checkmatepharma.com, recommendation or documents Acquisition and SEC. Schedule available the on and statement stock website Regeneron’s the on Copies with Checkmate free on call offer Landry team of and the the offer solicitation earnings sell tender on

Dr. and decision and will SEC any about contain of call Chief to making before filed Schleifer. because carefully the that, important You that Checkmate for With tender or consider Executive contain Len? our with securities should respect Len tender Officer, to the over let the other me offer. they such President should investors turn Checkmate stock with the review materials holders information offer

Leonard Schleifer

me I a in hope Ryan. Regeneron call your you warm to to team. well. will Thanks welcome earnings call. the everyone join giving for as Welcome of joining you stakeholders first Thank all the us

start off exceptional a an is to Regeneron XXXX, strong XXXX. in Following

benefits quarter differentiated continued commercial and our Our sustained were the we first investment our entire performance. by results with of research driven company development execution along across in focus realize to the on as

also value proven $XXX share continued this capital approximately three in million allocation, We including to of year. shareholder drive repurchases of first the through months

earnings double-digit Regarding revenue we our performance, share growth. financial delivered per strong and non-GAAP

continues grew to Excluding reflecting revenue of investigation core business revenues contributions diversified antibody cocktails, increasingly XX%, thrive. from COVID our our which

outpaced million to grew category. EYLEA to For safety EYLEA milligrams to for which XX% we recently billion We of quarter, efficacy $X.X EYLEA, by another investigational XX versus testament the than enhance increasing injections United more our continues aflibercept profile. including term U.S. surpassed primarily its well-established well franchise. last believe after up to retinal our in utilization XX% a significant potential nearly a sales long diabetic in yet as billion complement anti-VEGF In population, growth globally, the States, $X.X global revenues for XX the and an the as net year X first growing population, the milestone among represent EYLEA driven and aging rapidly years, opportunity

the the approved currently quarter in in global FDA-approved FDA-approved this Libtayo seven exceeded inflammatory diseases. for opportunity look capture continues pediatric in atopic last significant nodularis. early treatment significant of where remains we even have more it revenues and three dermatitis, standard to non-melanoma For share patients the XXXX, U.S. to one, care. potentially indications suffering U.S. forward XX% reach $X.X of prurigo year the including treatment approximately as in already XXX,XXX continued is quarter considered in esophagitis, eosinophilic of launching no oncology, today these we increase to A systemic In to Collectively, indications, skin Type cancer and patients and from new indications in are billion, options. Dupixent an to redefine X later year indications Dupixent but

this States, which helping in allow would cancer build to foundation Libtayo launch address to non-small larger United Libtayo generate beginning of population for we’re the a post-chemotherapy non-small to lung monotherapy dermato-oncology, cell lung cell potential Beyond patients. momentum in a much year, later cancer of

agonist, we Regeneron’s those we difficult treat collaborations. receptor acquire pipeline our will Pharmaceuticals, announced including to be Libtayo to our backbone pipeline, co-stimulatory In development Checkmate’s to toll from with our a in we Checkmate to in bispecifics a programs As combination and company. Regeneron’s and well acquisition to our as April, pipeline promising various we for modality the immune-oncology have clinical it differentiated foundation said Upon expect approaches agreement as bispecifics antibodies, investigation expect serve new X of add as for to cancers. to vidutolimod first-ever of candidates before, potential of consider our continue closing other strategy

ovarian our prostate Looking ahead, track for share cancers, XXXX, lymphomas, and BLA difficult half second Regeneron refractory submit our a to we tumors, best-in-class for to and data B-cell remain advance in solid on potentially CDXXxCDX for to the year of BCMAxCDX treat Odronextamab, such as bispecific bispecific. to this

might for response, treat toward well who Finally therapy COVID-XX not to antiviral to ongoing vaccines role, endemic protect as as individuals will the do interactions. respond tolerated adequately remains regarding an is that trigger monoclonal whom believe continue oral or patients well combating We likely not our to infected to to committed drug-drug serious as stage. COVID-XX immunocompromised antibodies we particularly play important firmly Regeneron head the virus an

month We multiple their a initiated against BLA omicron as last of are variants, lineage, first prophylaxis. including to and human those progressing treatment the of for our next-generation antibodies active study FDA that in REGEN-COV COVID-XX review are concurrently be designed continues and

bring possible. pathways we to quickly working our to year. we made clinical our regulatory as global are so collaboratively additional strong safe options with momentum treatment closing, as progress monoclonal advancing have In inline authorities pipeline them closely and excited establish to We’re far the and the this commercial regulatory and about and effective and other for portfolio patients

For confident are discuss. or up strong creation. of to which all long EU U.S. up in George for long in productive, XXXX, to remain the position, from eight programs, a to regulatory and EU highly additional various continues financial for other business well positions and term and data will growth data sustainable pivotal outlook be the term we we remainder our aflibercept as to pipeline deliver X filings, We Regeneron our as of value which approvals, additional U.S. pipeline read-outs four and milligrams, other regulatory anticipate

turn Now to call will the over George. I

George Yancopoulos

I the Phase week will for ophthalmology encouraging today. CANDELA AMD aflibercept of Thank efficacy [indiscernible] II points and safety numerically XX start favored you observed with the Len. At through whether X results aflibercept while and of for signals presented ongoing. III drying, through we and in X milligrams milligram recent end end primary anatomical aflibercept other more can with meeting, with The new study wet Angiogenesis Phase dosing no points milligrams in safety patients PHOTON III efficacy dosing in and safety. objective Phase intervals to PULSAR week studies, studies maintaining is determine XX. acuity, extended the DME AMD are wet visual primary allow X measures in

both Phase both both primary and doses. XX to every point arm of while positive, less We an mean an three at in are X week best end design and met patients The milligram frequently. groups: week randomized inferior Regarding the if and at aflibercept dosed half X PHOTON aflibercept study, arm, approvals PULSAR and to regulatory X III milligram early loading baseline milligram U.S. to for of the aflibercept XXXX. change arm, studies year in EYLEA an these anticipate and PULSAR or be acuity, XX is end week X following The primary every PHOTON BCVA milligram file X if X visual every in of is corrected will point week second the by EYLEA EU results not XX. milligram in being this

we which AAD positive our progress, in this with study announced need. unmet in second clinical nodularis, a disease had meetings a quarter in At January of and the updates AAAAI prurigo and we from CSU, urticaria, III to Dupixent, terms regulatory high biologic nodularis and eosinophilic III year, our remarkable Phase Moving chronic naïve detailed we positive study spontaneous and positive presented prurigo data presented also from patients. Phase III in esophagitis in the in data or studies in first Phase detailed

in patients CSU in read the two did studies interim statistical of study the March, to out in as completed refractory an in data to half enrollment first reach in next first first Dupixent III III and announced the omalizumab of this year. Phase and Phase we anticipate significance COPD second from in analysis, study not The have

In months five decision children years dermatitis atopic terms to expect regulatory PDUFA FDA moderate X June new date. the an severe for Dupixent by with aged in of progress, we to six

Allergy We Black are to Hispanic in Diseases, Institute trial children National collaboration of also and excited underserved about for Infectious and in Dupixent or efficacy in the an with and the United including asthma of safety assess upcoming NIAID, the populations, States.

and years and Additionally, we FDA submission by our supplementary our an for August nodularis this application completed decision FDA in XX X, eosinophilic expecting prurigo regulatory anticipated of esophagitis for indication patients older BLA with are acceptance in shortly. we

are as potential of were our follicular we upcoming CDXXxCDX lymphoma bispecifics, non-small Moving efficacy initial FDA for Detailed are human in our well our combination well for these from outpatient we the the submit regimen, late the our diffuse oncology Libtayo potential from soon. Hematology tumors. combination study Lancet application the later planning refractory results investigated study BCMAxCDX DLBCL fast and antibodies of first multiple year, track and our approval our In granted in myeloma, the in data cancer, pending with the remains has this lung hematology to the half updated Based follicular to the XX oncology, recently data from regulatory of in registration B-cell bispecific feedback, step-up has and programs relapsed administered with bispecific setting. the care including readouts as on and data are milestones We begin from forward filings complete stage published will potential in large pipeline, earlier feedback believe XXXX products dosing to in various shortly. for are solid FDA set Libtayo to investigating Studies safety of an lines we XXXX. within updated the umbrella of pending readouts about and and to for in our both be regulatory chemo for hematology, multiple FDA. candidates look myeloma and lymphoma decision Development in investigational disease observing for excited profile our in enrollment in or on regulatory enrollment our on designation regulatory first entirely as expected standard was recently track cell and Odronextamab REGNXXXX, as filing this we bispecific best-in-class Odronextamab, indications.

initial clinical bispecific for our with anticipate our non-small of prostate stage METxMET ovarian as costim well antibody year, disclosures as our The stage met-altered the cancer, for cancer. data bispecifics: monotherapy for late second Libtayo in bispecific MUCXXxCDX half cell combination we lung cancer, PSMAxCDXX three in first-in-class late

limited also involving For sign any these response a late to showing stage with confirmed cancers, would be options, clinical patients studies be have promising durable combinations. and additional early

We oncology logical Libtayo July other prophylaxis it to continue to a of different bispecifics combinations combinations extended provided This and our pre-exposure pipeline, against in review turning oncology a antibody due our utilizing to to foundational inhibitor, anti-PDX FDA prophylaxis with of of with which discussions approach Libtayo broad to progress starts REGEN-COV. antibodies our as whether in strategic settings, its additional involves with XX. our is for and doing or announced, melanoma treatment augmented as with we are we BLA and by our the with therapy Briefly second with with agents portfolio. checkpoint use combining ongoing our of REGEN-COV action was as new the other COVID-XX, on date our FDA extension recently LAG-X COVID-XX data

As and a antibodies trial COVID-XX initiated regulatory process candidate advancing with in April. we human new in a next-generation this are continues, first

continue in are efforts in development believe this antibodies a medicine, genetics that Concluding for be unmet future is we our collaboration will population. to major pipeline. Regeneron where addressing patients advance disease to immunocompromised need for prevention We our continuing COVID with and chronic

to very as effect with first-in-class to our Alnylam, designed well For of therapeutics excited antibody collaboration our blockade. siRNA we as siRNA maximize with combining target duration about are approach

against in gravis therapies, switch antibody The siRNA test and first the cemdisiran underway and we’ll of plus we myasthenia combination, of naïve to are paroxysmal III studies treatment care for dosing these our pozelimab. hemoglobinuria, nocturnal combo CX of is PNH, patients ravulizumab are eculizumab. shortly. standard planning Phase be In including combination our or tested patients PNH, both and and

programs combination additional several in are pipeline. our pre-clinical CX, Beyond

work leaders novel the addressing targets NASH, Center. address to in Genetic by siRNA of continue Regeneron therapeutics to with We with use programs or Alnylam non-alcoholic steatohepatitis, discovered as several the

NASH data mid-XXXX. are anticipated in patients First for ALN-HSD

additional been progressing later an We RGC have recently PNPLAX second year identified the novel target, and has awaiting this review target by publication. are into and clinic validated peer promising a is that

siRNA genetically door levels of the Alzheimer’s for for Alnylam target using amyloidosis. or APP, program disease. this in initiated pleased also protein our in the CNS targeting has provided the joint we In potential report that we precursor and a this angiopathy to are first We CNS for to multiple our target Showing amyloid open amyloid novel cerebral knockout milestone, on update quarter, transthyretin the CRISPR-based protein, can siRNA neurodegenerative and that development Intellia an reduce diseases. both program the defined first approach clinical in approach and

Just editing to remind you, genomic first the beings. this of achieving is example CRISPR-based human in

with reduction XX% greater transthyretin observed for patients amyloidosis acceptable so recent as far. in polyneuropathy, of achieved period demonstrated hereditary transthyretin observation with update as follow-up safety the than Our durably well

working well CRISPR-based diverse liver, includes and that with the candidates Our pipeline other bio-targeted we hearing programs. siRNA gene programs, approaches with brain of forms our loss our genetics are Intellia diseases congenital of as addressing and targeting delivery and Alnylam the on internal Decibel a such portfolio with in eye, as the medicine of as collaboration now

to potential the change we have call early, medicine. the approaches think With these the Marion. I still will that, turn of While to groundbreaking practice over

Marion McCourt

George. you Thank

global EYLEA, $X.X the our grew XX% Our strength with reflects year-over-year and first execution portfolio. to diversified sales first nearly commercial of strong billion. performance the in quarter growing and net quarter Starting competitive

physician grew position. approved net Across treatment is anti-VEGF continues as EYLEA to preferred $X.XX same strengthen as XX% world as its product the safety leadership to billion real the indications, based and and extensive U.S. its efficacy EYLEA Over differentiated on sales period, well profile, experience. patient

launch. EYLEA EYLEA million to Len to share under-diagnosed Category In notable important increase receiving EYLEA proud diagnosis eye growth eye As for We treatments from seen as, approved across remain helped future increases patient the incredibly we vision XX disease will patient patients diabetic believe source patients initial more market since and under-treated. world that all or and of ongoing continuum have we continued the through than most are of with remain treatment. disease, an indications. save the across unfortunately, around growth diabetic mentioned improve EYLEA

EYLEA, a III major the milligram performance potential X milligram. Beyond confident results, X treatment our be potential a our of investigational are to clinical EYLEA based on continues X aflibercept and program enhancement excitement Phase high the retinal has milligram to ability maintain leadership interest to supported long Regeneron’s by to level paradigm. in aflibercept and of current the In generate anti-VEGF If the community. aflibercept over term we future summary, within

to prescribers net now U.S. non-melanoma $XXX improving number based million, indications. Turning sales net sales in of the on non-small has skin cancer pathways. of in in of that monotherapy awareness, were FDA-approved and Libtayo based networks an steadily million increasing feedback, growing and global positive our lung quarter indication with Libtayo, brand cancer $XX included first cell The number across on demand institutions and prescriber protocols have increased

to are this of combination build chemotherapy Libtayo ahead opportunity potential this for later on year dramatically the that in cancer. approval lung expand expected patient working momentum the would We

a Dupixent, onto growth in again XX% net which increase remarkable Finally $X.X billion. for to achieved sales quarter, by global the demonstrated over

across systemic line uptake differentiated with indications specialists ahead. potential and mechanism $X.X June and rapid is indications in U.S. as and and to dermatitis. could established benefit the in treatment grew prescribers atopic patients patients across Healthcare as well and are performance six estimate biologic preparations was medicine net disease. In recognize approved potential dual billion. ILXX for XX% first to the for underway the XXX,XXX potential significant group. Dupixent as fueled from Dupixent currently severe profile. children in anti-ILX the eligible indications, with product XX,XXX More this growth worldwide approximately safety which moderate is for Dupixent’s young In label patients. sales atopic Our We footprint dermatitis, Dupixent U.S., patients launch action profile, with compelling of age younger months treatment of future an including geographic expansion as symptom use age well robust in includes all younger by expanding transformational a are than children efficacy, on relief, all

and ease remains Type initial concomitant look prurigo are Many of the growth on action, choice new additional steroid-dependent based indication, nodularis to Type label, extending demonstrated Approximately have forward benefit and of launch. unique in patients prescribing mechanism dual and pediatric There medicines. treatment patients including and where In continues with polyps, potentially from may nasal pediatric launch. positive another currently administration, patients options include dermatology highly in years safety, asthma need the asthma also U.S. use allergists on its Dupixent’s disease. preferred trends to Dupixent for In healthcare PN patients. both with conditions, broad XX,XXX from Dupixent allergic label Dupixent. competitive for patients compelling We X X after even from differentiation the suffer are no FDA-approved disease based grow both professionals to ENTs with or rapid its biologic three recently

there underway esophagitis, multiple Type preparations its efficacy simultaneously address and For no are safety need. significant not to potential same are individual X to only FDA-approved example, profile asthma. more but even diseases. Launch the patients program, into Type differentiated in expanding its atopic diseases is patient. forward had dermatitis medicines where in in and X also Type XX% our indications We also Dupixent eosinophilic by FDA-approved unmet for X Dupixent clinical of look

asthma. benefit EOE, dermatitis approximately XX% Dupixent patients Importantly on XX,XXX alternatives who this from especially Key of lack approved for our had the in in atopic opinion program, from in clinical patients could multiple our provide estimate feedback of also we given suffer If leaders EOE data, treatment least patients in at approved their indication. continue or positive symptoms. to the effective EOE clinical U.S.

grew the U.S., XX% Dupixent Turning markets net to million. first to in briefly quarter in $XXX outside the product now sales

has the the see markets efforts our Over we commercial Regeneron In the expanded sales we and that change with past for in key Dupixent In our and to Sanofi. performance we of in several across our summary, so progress year, significant far their families, we to portfolio. initiatives patients are need. to continue presence pleased United integrating potential will lives Dupixent States, bring to with those and are conclusion, with outside continue encouraged advance

to long advance inline and We on sustained positioning for launches, are term track growth. future Regeneron continue on brands to and our deliver

I’ll the over turn Bob. Now call to

Robert Landry

Marion. unless and My to XXXX you and on bottom a business. financial is off otherwise comments be with in on the strong the driven Thank double-digit today basis start first Regeneron non-GAAP across execution growth results Regeneron’s will quarter, by noted. top line outlook a in

revenues First grew quarter XX% to year-over-year total billion. $X.XX

related the total antibody revenues cocktail, Excluding COVID-XX global strength continued to revenues business. demonstrating core our of XX%, grew

grew $XXX recorded our were X% revenue milestone share total which growing on quarter, in of recognized billion. XXXX. Bayer by net on $XXX upon million and first collaboration sales currency sales first ex-U.S. XX% the per revenue XX% was Total reported quarter Sanofi collaboration the the quarter driven XXXX for outside $X of a a prior net U.S. EYLEA a for first collaboration $XXX achieving XX-month and basis Total revenue In product collaboration this of was profits Dupixent. EYLEA net on basis. on ex-U.S. of quarter the $XX with from products $XXX million antibody from share versus aggregate rolling grew to year, we we million, million billion basis sales sales Beginning million, constant income diluted quarter XXXX with Bayer, of First starting net income XX% and $XX.XX $X.X

of to Ronapreve in XXXX. additional of revenue this primarily related collaboration of Finally, recorded revenue outside Roche’s We collaboration Roche do U.S. the second we from $XXX the expect million sales half

not execution for first expect U.S. Absent U.S. quarter do XXXX payment of This this did fulfillment REGEN-COV first we U.S. includes $XX Ultragenyx not for record contract, quarter in of U.S., the to a commentary earlier this market with revenue any consistent in and sales additional million in the of Evkeeza government outside any Other the year, to million. XXXX. $XX REGEN-COV REGEN-COV from record year. the sales of we our our collaborator, was an upfront Regarding the from

XXXX, our Moving COVID XX% increased for expenses, by million costs, REGEN-COV. costs by of presentation R&D we quarter clinical upfront clinical including the trial and with and offset operating as headcount our to $XXX are now to of changing R&D payments and the driven Starting to first antibodies, as non-GAAP in agreements. acquired partially next-gen collaboration well opt-in results in acquisitions, higher related lower to in-process connection include license asset manufacturing for

outside year-over-year to growth costs recorded million, due higher were quarter Praluent supplies for $XXX year-over-year the shipments which million of charges payments we an to higher organization. XXXX, Process and $XXX increase of In forward, United XX% of due was of now Sanofi collaborator, In include expanding Acquired for results aggregate IPR&D Development. a full primarily expense, million R&D all Dupixent COCM new as acquired upfront support year fourth of opt-in to non-GAAP Research and expense increased non-GAAP million both $XX States. line which headcount our first million, the and these SG&A to commercial item to Going will XXXX. a EYLEA sales and from increased of in $XX initiatives quarter GAAP XX% there includes in related $XX were Adicet. in payment the excluded in XXXX, to our In to called

sales quarter in tax Regeneron generated now of was ended first cash XXXX compared collections and quarter inclusive flow, in prior to to debt securities XXXX billion for marketable of the quarter the the of less XX.X% recorded $X the of the of rate free XXXX, first Finally, U.S. and XX.X% in Shifting REGEN-COV of quarter fourth with and cash $XX.X Government year. balance billion. XXXX effective first cash flow the from sheet, the in

for Checkmate of agreement million. week, and We the to for allocation Last deal conditions. regulatory and Checkmate in $XXX Pharmaceuticals our continue announced to tender subject month, close of on acquire launched capital value closing total receipt expect we approval we equity mid-XXXX priorities. Earlier deliver to the to approximately this customary other shares this offer

we of in addition, In of the shares quarter our first $XXX repurchased million XXXX.

be with price where XXXX to and we dislocation our continue select buyers and our intrinsic year I full outlook. conclude updates guidance see valuation. to opportunistic We between stock will our

R&D full across guidance our be are updating manufacturing the and of driven COVID costs We billion. most to guidance recorded first in the $X.X which by The programs quarter, increase for billion advancing range $X.X next-gen in to in of were year clinical is antibodies, pipeline.

full Regeneron long guidance R&D available I our back tax our call the core range expect With of now our to effective XX%. summary also our be strong will We by business earlier pass is issued year sustainable release for financial term that, performing to engine complete our leaving in positioned press well rate in latest A this year XX% position, morning. in well and we continue investments to supported to Ryan. the of our full make is conclusion, growth. In

Ryan Crowe

ahead. to for Gigi, now callers With Q&A. prepared before Thank as the XX than you more concludes one open questions next. please we the queue Gigi, and able many remarks. each the call moving to in as possible, go we ensure question caller to address will to from that Bob. We’d like answer our are only

Operator

first Our line from of comes Raymond [Operator instructions] Piper from the Sandler. question Chris

now is open. line Your

Chris Raymond

Hey, thanks taking for question. the

bit talk highlight from market of here, J-code. of permanent kind net know on thinking enthusiasm maybe a little to Vabysmo in muted, I striking have forward? I I from to high you know should the dose of a actually set. into docs of Just and you but pull how least term, drug. feedback they which counterstrategy there’s a but EYLEA, Marion, has about maybe Thanks different the of how lot if have the a are not near the lot format playing on said it’s competitive launching They the Roche pricing about guy the guys we rebates, be viewing how the you lot can, and and intermediate a after can your of somewhat what question of going EYLEA been happen is reception know a will is talk I about for levers

Marion McCourt

Chris, of happy to give you some the characterization market.

First on comment let EYLEA. me

today, and As performance performance across competitive than competitive marketplace gains but growth certainly very market quite EYLEA reported of fair in strong with indications. more also strong our indications, only in we share share we not across our see very certainly a the capturing is

about the let marketplace. XX% the in importance of the and in overall leaders efficacious with of see VEGF safety of EYLEA, and of with reminder, a branded market comment prescribers on that share EYLEA best comment Roche in we marketplace has product I have think the new their been the probably it’s over to the extensive branded profile share. uptake use market in-market certainly I’ll the As that do to demonstrated the that and really share market XX% they have, the key we indications on robust. incredibly us opinion consideration and category across

a strong I experience, of things category certainly and generally items we relates leading the to other pricing around As we use. see don’t in is that terms certainly say with will EYLEA sort, that leadership and that but profile ahead, uptake of and it comment; looking

Ryan Crowe

Thank you.

question, Gigi. Next

Operator

Thank you.

Cory question Kasimov next of Morgan. line the comes JP Our from from

line is Your now open.

Cory Kasimov

high for about up on guys. good wanted the I morning EYLEA, follow To question. to formulation. Thanks ask Great, dose taking my

market? segments about anticipate, out the primarily could your how would over this this potentially current product Is from read to in be results or do it slotting you used it expect possible think the of Assuming treatment take broadly Thank you the dose, as into you. certain landscape? you

Marion McCourt

patient profile planning, clinical to clarified. need considerable of we data preparation is product as the I point, then course more launch and up how and product certainly on how wait profile as on We look matures and I but think profile need matches the to data the at we’ll this optimistic, think wait at the uptake. of we and be move we’ll against into clinical opportunity, matures remain and of so come see want specifics to

Ryan Crowe

Gigi, Thank question next you. please.

Operator

Thank you.

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

now is open. line Your

Evan Siegerman

say, taking question. of Checkmate rationale particularly the if that Anything for acquire I’d much proposing behind the Pharmaceuticals. notable you pembro you doing in that had the you. your diligence do acquiring they go forward Hi expect Thank their trials? interest, expand love when was versus, or nivolumab guys, thank were prior asset to Libtayo with as combining you could data to piqued and on on your so some their or you

Leonard Schleifer

George I’m the discussion. we’re anticipate. that closes committed look just would thinking, really offer, to expand the love as tender assuming year, the the to that that here. but unfortunately launched not to We’ll deal sure we sure--it’s I’m discussion middle we around because a have Len of forward upon

Evan Siegerman

Fair enough, enough. Fair Len.

Leonard Schleifer

Sorry.

Evan Siegerman

No, it’s all right.

Leonard Schleifer

for But that if question. because the we couldn’t answer come question, in get back you back another to queue, we’ll you

Evan Siegerman

Fair enough.

Ryan Crowe

Gigi, next Evan. question. Thanks

Operator

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

now line open. Your is

Salveen Richter

for thanks taking my Good morning, question.

set see in sets we’re On the from the these initially clinically initial meaningful? data in see then data of you exactly what to would you bispecific second could in to solid terms to just going half, want tumors being speak what and

George Yancopoulos

Well, basically late my going patients as stage in remarks, pretreated. I heavily we’re indicated into

and combinations become in significant open each number other in patients. but both logical hoping not agents. one to stage of report patients. late latest earlier one logical is and seeing to course able We for of could only numbers stage these in That with those looking the going terms responses, actually them significant that important able duration the Each see in combination also them, then durable of of with we’re but making is responses one the to for. difference would we to and very stage really objective the be We’re of of a program, love showing responses a think, each be novel monotherapy what on would settings agents up back opportunities of particularly earlier to

is So as responses duration we’re programs. what in for three those of I said, with all looking

Leonard Schleifer

of is treated while is bit, these of lines in reagents, to in reagents, agents, late the make Just very to the earlier most finding difficult these activity start patients, with types anti-cancer there would encouraging. it as missed with heavily the better that George be said, you in latest, what amplify it kinds sure case so is nobody activity the to little case immune be much other that a that just with seems

Ryan Crowe

please. Thanks George. Len next Gigi, and question

Operator

you. Thank

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

Your now line open. is

Brian Abrahams

and strong and ultimately so this my similarly I with efficacy all stepped the for in you dose? seeing means safety much taking then Odronextamab on retain it development Could that other terms the and guess bit you’ll and your for a Good confidence T, thanks what you’re progress, question. Thanks. in morning, of differentiating elaborate more congrats versus CAR little that bispecifics on dosing, benefit up

George Yancopoulos

the further the future, seeing we depressed that we’ll early release rates even from dosing, presumably data gradually our low were our dosing cytokine were in FDA, at same new dose, promising. had significant rate the looking give with and results to cytokine actually some you field like as with players looks severe dosing, is step-up saying which step-up data detailed that own still the are we’re early collaboration obviously for dose, point timing regimen, what the but effects, already be we that program. syndrome gradual it’s the give actually reducing up the of concept getting our very low down we’re are and from that up very a The your only one of read step-up confirmed original to the dose had to at this I use in approach particularly we will what It incidence step you came in the in side safe, we them promising you come this other think, regimen where by as we syndrome. an of able and we very initiated of is with this Yes, data setting. up get in be people’s to optimal stated, just It’s and a We that we’ve concept bispecifics outpatient the general outpatient maximum the low to extends the as well. short with doses and to what to a pretty dose could so a when original, week by settings, that redefined initially stepped getting more used even and period up of protocol it’s to release time looks and and be was in and pretty same the in maximum also be rates regimen safe dosing dosing seems to like

Ryan Crowe

George. next question Thanks please. Gigi,

Operator

Thank you.

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

open. Your line is now

Carter Gould

good out about broader you’re recently, when morning. themselves me pharma argue One you indications I you from and and guess, CV to - a of forward? We’ve biotech contributors thinking commercially Great, sales. CV relatively products, CV Thank I’d small credit get really rededicating much effort. major I broader and this a and from pipelines Do across your for bit want one it heard the but map you just your little the understand going to larger you see your companies relevant better. like to number of have how being to ambitions understand, for area Evkeeza don’t Regeneron and Praluent I’d you. here remain a

Leonard Schleifer

may some our it’s think of which We now, have to rethink do that, more performance. major But we not require contributor capabilities, the not expertise reagents are we a near of combinations on and right types hear and hopefully and to CV how term and both obviously potential realized what of of would you’ll ways is we agree full our to that. exploring - targets, us

Ryan Crowe

Gigi, next you. question please. thank Okay,

Operator

question Brian Baird. line Our from Skorney next from comes of the

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Luke Hermann

maybe currently Brian particularly study more a will II excited this confidence about little your bit you’re the there? Phase talk filing, Hi, you granularity, is about Luke a enrolling Thanks. combinations and any for support timeline Hermann Skorney. XXXX, that Could the on

George Yancopoulos

larger deep possible Yes, we these that small it we Phase response competitive well replicate registrational able in numbers, undertaking. that stage registration with patients II rates should study for are duration can be and support we if think very have late we responses to in the

very We the and acceptable to first a step said, tolerability is safety in the this profile, and program. you whole see just as continue

are about also lines combinations moving to We about and earlier very of we’re excited very excited therapy.

preclinical combinations, and bispecifics compelling. enhance The bind that it’s single potential really the activate talked now but deepen to to also terms and of responsiveness refer data the with combinations be very so-called cells very target as we what very two, about costimulatory logical on myeloma the before, a has as In are and and duration. exciting others and responsiveness same deepen will we’ve to

lines responsiveness We and the also additional therapy going we opportunities is going the that of involve of on a series series obviously, combinations costimulatory get into deepen therapy that - layer and only molecules, we’ve summary well earlier thinking cures, as Phase we’re dare already of and, of responses logical get possible the well. and could top late these our so and I which to basic potentially candidates to as the registration seen to responses, that combinations next the study, longer programs our adding next-generation have that Len mentioned, ongoing with and even replicating increase longer three, that’s in of say, as enhance duration, by II registration data going of lines earlier responsiveness to setting

Ryan Crowe

please. Gigi, George. question Thanks next

Operator

Thank you.

question & next Woods from comes Company. line of from Cowen Our A. Brittany the

open. now is line Your

Brittany Woods

is our multi-part Brittany bit cocktail. taking question and for on another this question. REGEN-COV everyone, the related morning quarter for Good A on Tyler. a thanks Congrats on strong

forward do if path we will also, file For approval you’ll regulatory next-gen period when that there? case and candidates, and ultimately the could ongoing a the endemic to what relatively the for look studies trial a be to we enter you in like; phase, be of expect continue like able as pivotal low look the what

George Yancopoulos

to for cocktails These are regulatory so and existing have we about potential obviously great change, but for that at and the either, questions, next-generation all ongoing also with cocktail, continuing are program the going both full this hopefully the associated great getting our our really path regulatory studies That’s approval of FDA. talking path point but potential for our forward discuss not support details has change, questions. to to to the an we discussion are that

Leonard Schleifer

and to are is it manufacture what think which capabilities get and of to monoclonals said, a we’re the solution, speak. to make they increased as variant thinking we which George chasing would the some it’s have knowing still, in to as that, so agency situation, an well, for you keep I we variant But complexities but with committed think to part there. out when antibody we’re greatest end-to-end about say this authorization, take the discussions it and complex Suffice in how what to start to be, going to the about require the it chasing and but science, always is fairly important next is you’re an but have supply as can try artful space so probably,

Ryan Crowe

Gigi, you. Thank question next please.

Operator

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

is line now Your open.

Dane Leone

all those generally that and a that interested the able think when treatment a - up To becomes progress Hi, CANDELA and comparison have it XX-week, real questions, in actually patients these are I standard so higher EYLEA? extra label complement really a I’m PULSAR to dose, much. be hear for to it what be I’d guess, and being over PHOTON hear Q thank many to from your the the your team interested of of right that team’s differentiated years interpretation of outcomes. dose all readout across that taking point, the to your out impacts care. on does and does terms on a narrative your have that EYLEA, PULSAR, and been commentary It’s and ends how on have of and congratulations from to in your what next-generation the to through now you PHOTON question for interesting your treat really as been on One me EYLEA programs. a think high outcome should efforts is displace a guys against little the of be the meaning that put the dose for the and is are compelling higher failed get to lot in studies to option contextualization this, any make of actually to very running used fair you [indiscernible] other obviously aflibercept the read dose who you that these dose, agents high studies The just market of equivalent, versus not to if available. comparing you in generally how studies I’d these world but per out quite studies Thank with the inform EYLEA option context [indiscernible] drug an or contended loading extended EYLEA extend

Leonard Schleifer

occur of transitions from data, do million and I paradigms that do thus CANDELA numbers, views decide to You not efficacy going safety, - only anticipate molecule. is say, kind bringing can’t the think all know, EYLEA from an higher for the new the that the whether that we a sort and duration, duration, we dose feel you’re same get than advantage molecule matters, can with choice dose to dosing clinicians with we’ll duration actual unproven we but what we and think once point dare that transition injections having to I wouldn’t of a be I that’s look strongly seen Frankly, the but new is be safety they’ve they with have do consideration a but important safety when We that for molecular far the the--when is you’re of for the in small think it. high immunologic the more still efficacy known same is with study matter; different going If the backbone, sorts with see reactions once behind EYLEA we the to speak of drying, distinct longer obviously more having changing mechanism of transition to data, get you’re and I safety will is FDA does think we I clinicians that molecular those a if new we than because entity. the view, than allow even think extension and kind a duration, things, well XX very at EYLEA with the switching perhaps reagents. a of of efficient more action may of a paradigm same is attractive

Ryan Crowe

Thank you for two we more Len. Gigi, questions. have time I think

Operator

Thank you.

Charlie Morgan of next line Yang comes Our Stanley. from question from the

Your open. now line is

Charlie Yang

BCMA in approval [ph], example, ahead the terms they year, bispecific. maybe darsivax you. for competitive up XXXX your testing Thanks combination to competitor given thoughts about outlook, my This the could REGENXXXX in are just is and question. for here with some just its Charlie on I the follow this across and guess for Thank later commercial curious line already is want just provide the of Yang the confidence landscape question is on I and on Matthew. taking potentially on settings. opportunity you different the in I’m getting

George Yancopoulos

isn’t course also or agent of Yes, we is, that have think being behind marginally going It’s ahead mean how actual what to much. opportunities your really here for combinations. and you good all

combinations game here more monotherapy, or and about do with we agents, can initial believe the that changing, those are we importantly, and be both we in as, traditional, can whole in program, competitive very you so not that efficacy the as as terms interesting, in really take that’s and most of being the in interesting very, this more behind we make really such our ahead portfolio the your it come different going settings level, whether opportunity we’re can combinations, potentially bit is in bispecifics in have take combinations of our what extend hopefully another game is costimulatory But if really agent a seen that and if logical II why with changing to earlier combinations in have late with it’s a stage terms important will program. you that not stage agents. traditional will these be efficacy, really the think novel a think reproduce than also little opportunities, and some and good said, we settings that have so to which obviously can matters. Combinations, as of we really excited efficacy We studies, data. it potentially but we see producing just pivotal Phase up very that we the As really we’ve

Ryan Crowe

Great, question George. last Gigi, please. thanks

Operator

Thank you.

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

Your open. line is now

Mohit Bansal

to in milligram would you Maybe a are It on the trial. in. your dose five question EYLEA, Great, for like high me of love get doses design there monthly thank the squeezing take EYLEA. George, X and DME on us EYLEA walk high please you seems dose label, through wouldn’t this three disadvantage? arm. the difference, the Could the arm, only behind Thank like at X put rationale a for you. just this but milligram

George Yancopoulos

the and well dose Obviously you the said, a being of with PHOTON speak. high be injections very challenging, is safety aflibercept. what EYLEA, the certainly data to the than reduced dose It challenging whole less said, the accomplishing it deliver that is important, in results high is goal milligram X to and will the but I for goal safety, guess with with Len efficacy the the injection is, but schedule. dose, the same EYLEA and but the as is as loading it that’s goal Yes, is, more higher

Leonard Schleifer

said, I efficacy think but can optimistic. complicate get of a looks some eliminate we George it, I dose, we we on and like we Yes, loading of could--we’re might obviously, high if know based too when the what think this readouts; it as it designed

Ryan Crowe

you. All thank right,

the I think call? Gigi, we’re done. Thanks we Mohit. conclude can

Operator

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

disconnect. now may You

Regeneron Pharmaceuticals (REGN) 4 May 222022 Q1 Earnings call transcript