Regeneron Pharmaceuticals (REGN) 1 Aug 242024 Q2 Earnings call transcript

Welcome to the Regeneron Pharmaceuticals Second Quarter 2024 Earnings Conference Call. My name is Shannon, and I will be your operator for today's call. [Operator Instructions]. Please note that this conference call is being recorded.

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

begin. may You

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

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

will forward-looking risks and guidance, could events prepared and finances, reimbursement will is actual development may collaborations, related I statement. milestones, remaining coverage to, time minutes. Such those related anticipated remarks, payer differ you your would products competition. are matters, be like to to our that from results regulatory intellectual and financial Regeneron include, and Each proceedings in to materially property, subject that questions. its statements limited pending remarks issues, forward-looking the statements call forecast other approximately today's today's last and may programs made on but and remind litigation projected uncertainties and XX business, for and statement cause After and Regeneron. call those about that include available We to anticipate not

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

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

With that, Chief Leonard over and Schleifer. our Executive let turn me the call Officer, Dr. President Len? to

with Ryan. earnings everyone revenue strong call. joining Thanks, Thanks to broad double-digit advances important pipeline. of along the our continued today's highlighted growth its and record by Regeneron across in quarter, track second execution

review opportunities. our today, my I'd key my review year to commercial then on For our discuss and drivers full like the guidance. After results near-term briefly detail Chris finally, quarterly And performance. remarks performance will will provide will discuss pipeline financial further our updates George some our for pipeline. and Marion remarks, to of then the quarter, updates

prior on for sales its billion, Net category. combined a were EYLEA anti-VEGF the HD and continues EYLEA recent third $X.XX the in year. growth quarter the outperform robust growth million Second the quarter collaboration EYLEA XXXX HD as performance well United continued for grew EYLEA $X.XX generated of Sanofi LIBTAYO. driven strong of sales as by to Higher States. billion, revenues the revenues primarily total in DUPIXENT reflecting X.X% in $XXX to full product to HD XX% compared U.S. and launches market representing

share We of maintaining EYLEA strong achieved space, while we are in trajectory XX%. EYLEA HD HD and a the EYLEA have that anti-VEGF market despite category-leading launch combined competition encouraged our increased

by potential XXXX. pre-filled pre-filled syringe early an United bring to towards efforts a remain market EYLEA syringe, we States are tracking Our the high and launch HD priority, a

European specialists. indications, strong the growth eosinophils, first the This approval approved all approximately billion, represents in address The groups position retinal regulatory differentiated approval diseases DUPIXENT global among approved for the profile, for based this grew patients blood disease. maximum on treat with coupled DUPIXENT Global strong in to uncontrolled continue that summary, with the retinal revenues enables In are on $X.XX HD across marking clinical to approval approved eligible in EU a eosinophilic DUPIXENT standard constant basis age its currency and the for raise patients first to care DUPIXENT geographies. Commission we biologic new to on COPD. reflecting June, COPD and COPD currently therapy. also as XXX,XXX EYLEA of and XX% the satisfaction familiarity In

and our continued XXX,XXX competition, eligible $XXX on sales cancers, were making significant the its partner, inflammation second date. launch potential COPD high indication skin expect million basis. We with an cell impressive maintained regarding has been prepared of ongoing patients Sanofi, anticipated. their their and review net in have increase LIBTAYO cancer. work Global unmet for There the and driver continue patients a for respiratory DUPIXENT's X FDA XX key growth. leadership while that a approximately by for pulmonologists, XX% opinion are LIBTAYO constant currency non-melanoma intense many with lung United in decision this in is Despite in with September PDUFA leaders type to the quarter, the States, its non-small and eagerly inroads launch our We need product a U.S. in represents position

with and we full from of LIBTAYO commercial pleased mid-XXXX. international in rights global made products the our have future an also other are purchase Sanofi in establishing support to We to following footprint progress LIBTAYO

manufacturer findings company's another linvoseltamab relapsed us third-party myeloma, multiple linvoseltamab a Regarding had from product for the BCMA review fill/finish FDA its the unresolved informed refractory preapproval bispecific CDX the linvoseltamab of candidate. inspection or during for by that BLA,

or and for been to efficacy safety, approvability issues therefore, status findings related August us a reinspection the have the informed While our any FDA required, likely we beyond ongoing believe date. we of be will resolved, trial. FDA delayed be now linvoseltamab XX has is these The of approval PDUFA anticipate potential not for to linvoseltamab any confirmatory

later in a excited readouts moment. distinct in to generate upcoming are several which or support and inform our and XXXX pipeline, development discuss will significant our opportunities this to several over therapeutic areas. growth XX that differentiated about In further programs innovative closing, long-term George clinical pipeline programs in has on continues spanning now opportunities could year broadly More we

executing Our our commercial team momentum and well in-market products is with categories. is competitive building in

continue capital delivering with the Finally, prudently shareholders. we to to value deploy goal long-term of

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

DUPIXENT. Len. Thank you, Starting with

from significantly a our data NOTUS, Medicine. published patients Phase recently late-breaking DUPIXENT trial, COPD, lung BOREAS featured BOREAS, in In and from Thoracic III at on approved the Journal care Regarding while NOTUS exacerbations Based reported by on data Conference presentation standard and of of second Society was the reduced American authorities unprecedented the New England European as from NOTUS results confirmatory the the simultaneously trial. for confirming health and therapy. improving maximum COPD uncontrolled XX%, by previously regulatory eosinophilic function DUPIXENT was

submissions authorities with other are Additional China under around review Japan. including world, the regulatory U.S., in and the

disease we potential Beyond and different forward later in world from and readouts of this approval DUPIXENT COPD data after deliver new X around studies X initial approval DUPIXENT Phase looking to the FDA to important chronic year, indications. its years with III are in for urticaria bullous additional indications approvals pemphigoid. continues spontaneous

for III food study our devastating second data submissions On to bispecific, BCMA development second expect small next disease end antibody our linvoseltamab our IL-XX innovative to now we see Phase by initial our by study for COPD our readouts using of continue severe combines of this year. and certain potentially eliminate our to approach pilot this CDX regulatory patients, candidate itepekimab, Regarding fully therapeutic the in for allergies X expected DUPIXENT that studies enrolled, the are in are and half year.

the promising clinical the with continuing LIBTAYO, ESMO look deepen combination meeting progression-free follow-up LAG-X forward in Moving melanoma September, most view of presenting cohorts the combination proportion antibody on at results that from immunotherapy in the improve. LIBTAYO first-in-human to Fianlimab, oncology. to and upcoming development. our continued median with to may have survival Starting to our metastatic and be our complete longer-term in with responders study. strengthen These fianlimab we Responses

looking new we other of in readout this fianlimab melanoma the announced, settings. position cancer potentially recently Phase eventually and to we setting melanoma forward which standard As could and care are a as next year, in III LIBTAYO

non-small Additionally, gain the activity this in antitumor combination later of into cancer lung this we cell insights hope to year.

We are of tumors. proof to lines with non-small of development cancer and earlier therapy to also with in lung follow. advancing for now bispecifics melanoma additional indications solid concepts underway perioperative cell fianlimab to perioperative On likely

monotherapies tested LIBTAYO LIBTAYO. with our results being numerous Conference, overall in as with EGFR of including combination cancer with patients metastases. immunotherapy well the tumor with in In studies, without to LIBTAYO. and demonstrated Our with CDX as activity for combination CDXX in antibodies bispecific presented combination we bispecifics ASCO in colorectal in as costimulatory response EGFR CDXX At historically by are encouraging stable by an unresponsive XX% rate liver antitumor microsatellite bispecific

safety, cell CDXX by non-small solid Regarding various stable our events with plus continue not we tumors, agent cell others. dose. our adverse EGFR Phase lung immune-related date, at LIBTAYO observed head late-line combined with microsatellite demonstrated activity LIBTAYO. has which On carcinoma cancer PSMA CDXX in or to prostate and without and when by cancer enroll with testing recommended to this expansion already to neck, severe bispecific, Dose in cohorts mutations, costimulatory promising colorectal squamous EGFR have II including cancer,

costim CDXX based with initiated LIBTAYO efficacy We PSMA served treatment the which bispecific the bispecific, with preclinical by our that profile. by of our may and may PSMA improve on safety have combination tolerability studies CDX maintain the now of combination

are We in cancers. PSMA CDXX also testing by other

linvoseltamab, we bispecifics potentially in which hospitalization demonstrate European of safety, the to our efficacy, hematology updated or presentation myeloma continue as data, as pivotal Hematologic for well bispecific, to Next, burden. at Conference Association dosing BCMA CDX profile oral best-in-class oncology, late-line the a by terms presented in an

At of patients, XX%. responses complete better follow-up with of to overall objective a follow-up. rate response response XX-month with As longer we achieved median an XX% or expected, continue deepen XXX

such of studies for significance are which settings myeloma presents precursor in earlier have paradigms. hemopathy in myeloma monoclonal of Developing treatment us their Additional smoldering unknown stages these now in complex and of underway and important conditions to physicians as opportunity currently MGUS. earlier-line linvoseltamab help and linvoseltamab diseases, in an myeloma patients or also

second of medical the now this of are of highlighted AX in of knee on thromboembolism is XI nononcology are fully year results by to our Factor expected our present setting the meeting domain Phase proof-of-concept Interim we expect second prevention replacement half for the as results we venous for a later antibody XI this domain Factor after analysis. in end catalytic internal the previously, targeting pipeline, results II and year. study antibodies at the targets enrolled, antibody surgery. the for our XI for X which hematology Factor anticipating Touching this The year,

an evaluate started to also additional peripherally profile registrational both for patients, inform Results in thrombosis of studies proof-of-concept have further have study X We prevention studies to antibodies catheter. of next X with year. these by to these who whether antibodies a or the inserted proceed will

Moving to obesity.

approach receptor agonists. advanced use designed negative is consequences of most address of GIP Our the widespread and to GLP potential

reported, has also it loss the caused is As muscle, these of in older, loss which been widely profound result unfortunately, patients. by particularly can concerning substantial agents weight obese

evaluates enrolling results, combined identified. study patients trevogrumab mass has report semaglutide signals Part has when fat Phase expect dose reasonable been muscle our testing of no active of antibody nonhuman healthy in weight, the line preservation our or in of II primates. previously including demonstrated we as of study, half with successfully body pace safety in myostatin with and now loss which protect combination completed antibody, new enrollment, second a to myostatin this top without obese muscle higher Part with to B subjects against mass assuming started with may A participants the changes and antibody by in a muscle or XXXX. of Our semaglutide continue our antibodies

I genetics gene. to DBO atoferolin efforts. At from with Conference, data hearing conclude due the presented will mutations the gene genetic we our of our loss medicines therapy updated ASGCT for program

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were initial dose age a in hearing at a improvements observed child We assessment X X-week with years also at plan. additional of second follow-up

dosed this have study, our we are we track patients As in to enroll more July, and patients on several year. of X

atoferolin with programs monogenic to to years coming forward forms bringing to loss. clinic gene look additional in address the therapy common the the more of potential also hearing We

cardiomyopathy, indicating with amyloidosis CRISPR-based program enrolling transthyretin collaboration, Intellia III in our Phase patients. Regarding a world's is at vivo considerable from first therapy investigators rapid the interest and for pace

gene in use to on to the a insert first In a for B. addition, we disease, vivo are to also hemophilia CRISPR be track corrective technology deficiency

of should have we previously, trial noted the dosed As in first portion and patients be soon. enrolled patient this leading initial

for successful genes has the in only in for in also to collaboration us the genes with but brain. for other opens the disease-causing silencing demonstrated after Alnylam liver, opportunities Our up go not siRNA the siRNA time first of brain. This

patients A study targeting synuclein SOD-X siRNA CNS-directed drugs to clinic ALS Alzheimer's in shortly, for with Parkinson's SOD Huntington's ALN and enter tau and mutations disease, of initiated. for HTT are diseases. recently including the other expected Other neurodegenerative for

drive regard initial with same the end by data our Additionally, involving an combination this indication, geographic pipeline molecule are reading out months. well, summary, our proof-of-concept this and to of program of data III the nocturnal of for first to year. over antibody and the together sets progressing several We're our present to forward updated XX pivotal siRNA innovative innovative anticipate the year. atrophy second is expecting looking in In also Phase the CX continue our hemoglobinuria an half program, we XX forward we approach paroxysmal development to both next and starting with potential to targeting in

productive novel potentially multiple clinic programs Our with efforts time over frame. to the same continue to that early research be advancing

that, And Marion. the I to will turn call over with

Thank you, George.

further solidify therapeutic Our commercial categories. second results leadership quarter Regeneron's across

Our our product powered growth by continued of multiple ongoing demonstrates product with the and portfolio opportunities existing diversity upcoming and across and launches indication geographies. performance strength

represents continues with HD in category second $X.XX for its EYLEA anti-VEGF trajectory decade and to EYLEA the EYLEA HD in competitive a grew start transition delivering EYLEA leadership than significant EYLEA EYLEA HD to sequential the in year-over-year underway. which I'll the clear confirms product highly medicines combined and the is since XX% momentum launch category. the medicine its U.S. while any second to therapy net net quarter, this HD of growing sales of In billion. remained sales EYLEA X.X% quarter, both fastest continues the growth. EYLEA fastest million, be $XXX HD ago, continued more a launch

treatments with are broad HD breadth EYLEA HD has population, and their a utilization switching across doubled to quarter. since to other range EYLEA last also of depth positive grow patients including on increasingly treatment-naive The prescribing continues of patients, which early from anti-VEGF based a Physicians along EYLEA patient acuity and EYLEA And these lives efficiency experiences. extended data treatment same EYLEA meaningful HD's switch with efficacy, indicate early the a treatment practices. patients, being HD. real-world and trusted as with represents that intervals for for greater visual durability, are improvement safety physician

more offices The for importance and new we code by syringe disease. as HD's we're has the HD reimbursement that providing quarter on quarter as to confidence prescriber HD as pre-filled our EYLEA during EYLEA well in EYLEA we're achieve care ordering a number of pre-filled EYLEA profile to for physician mentioned, the the second the our EYLEA now XX% physicians in compared In and HD We been establishing suggests of recognize with of clinical than established. EYLEA quarter. as our note, HD well second prior this increased option Of goal J syringe permanent performance with the standard pleased summary, of track retinal Len excited remain anticipated believe launch. about

to constant delivered sales currency on Next growth basis $X.XX DUPIXENT, net of a global the with which second in billion. XX% quarter

worldwide. milestone on We of patients are million DUPIXENT important the X approaching

even #X prescriptions all indications. need DUPIXENT indications. benefit XX% more U.S., demand geographies. position and continues across for increased $X.XX DUPIXENT opportunity across from approved substantial there's the grew all addition, and on an net billion, In significant leadership X new-to-brand based sales by unmet In its approved driven patients ages across to to indications,

patient blockbuster initiatives prescribing increasing that in support to drive continue see Our atopic dermatitis, awareness and remains of team laser-focused our we indications and polyps. pursuing commercial penetration on asthma nasal

are and launches and in age treatment of year. we EOE, eosinophils among and prurigo steadily Germany, recently as first medicine is remarkable Additionally, debilitating this disease recognize also January expectations stories are DUPIXENT already need blood on esophagitis this approved with significant year who thriving unmet in now increasing. in approval with recent the that biologic getting of patient patients as patients are all We in COPD DUPIXENT The of nodularis patients with raises eosinophilic following COPD. Commission our exceeding its patients hear young worldwide initiations new DUPIXENT European for represents X with there

Our from indication this FDA U.S. DUPIXENT team DUPIXENT approximately may patients is for rhinosinusitis approval ready benefit DUPIXENT in by an is separately, expected nasal the late for decision in September estimate of next U.S. anticipated month. FDA XXX,XXX and with polyps COPD chronic in adolescents and

out Phase the X If later spontaneous As chronic pemphigoid. potential from positive, this are George bullous with need. reading there data DUPIXENT unmet and in more these DUPIXENT III even to support programs trials are patients urticaria mentioned, year has

LIBTAYO significant with a in We market Strong constant global net skin the gains of execution and with up progress sales also XX% across in lung second made quarter commercial on million, both $XXX share resulted cancers. currency basis. year-over-year

to impacted in LIBTAYO net gain $XXX the by excellent delivering sales market favorably net we U.S., by with lifts million cancer stocking growth million non-melanoma In extend markets purchases. as $XXX continues all are cancer, our Outside leadership important international market $XX and share for million to of skin of to therapy gradually continue XX% approximately demand the teams physicians LIBTAYO patients with of these their lung increasing In international net results grew across U.S., lung product recognized share. cancer its as and some product continues Regeneron and sales with in market an indications. sales expansion. segments were

linvoseltamab in we linvoseltamab look Our potential best-in-class our late-stage eagerly best-in-class team is also provide FDA both worldwide. to EU to and medicines even on oncology to for long-term summary, In forward care. myeloma and commercial Regeneron potential a and believe launch. meaningful indications we -- opportunities decisions team approved patient robust represents the growth opportunity, and future our our to advance goal more to There continues provides deliver and within is potential near- patients pipeline our awaiting

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

from will and comments bottom quarter. Total Marion. the Regeneron ongoing continued unless $X.X you, Regeneron's results My of strong primarily and LIBTAYO. U.S., second noted. to outlook be the billion, strong execution growth Thank higher in revenue revenues sales line year-over-year top the in increased collaboration delivered and Sanofi driven EYLEA launch financial non-GAAP today on double-digit growth basis a on HD otherwise by XX% global

share $XX.XX income billion. diluted income prior Second net the grew XX% quarter per net from of year $X.X to on

quarter Second reimbursement commercial year $XXX margins. for Sanofi revenues million, XXXX primarily our to XX% of comparable Reimbursement million, manufacturing share efficiencies, commercial volumes, from to which and increased continue Sanofi component of manufacturing compared supply, growth and by revenue collaboration the profits was our taking account continued $X.X year a driven billion, improving other grew be by of to on to the basis. prior in collaboration to DUPIXENT's volume $XXX by XXXX from expect supply of into composed of manufacturing increased collaboration offset we full

billion development of approximately the reflecting balance of end reduction approximately was at the Sanofi from quarter. The end the $X of the first a second million $XXX quarter,

balance of by fully continue will anticipate the to reimbursed to XXXX. We Sanofi this be end

Bayer. to Moving

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

Now operating expenses. our to

to and quarter to late-stage continued $X.X expense our robust oncology investments billion, Second grew programs. pipeline, including R&D XX% hematology reflecting year-over-year support

months. primarily over to year in is from prior as anticipated by us to investments to to quickly enable by continue as the support programs into III launch HD make commercial international the EYLEA to Phase next to quarter, We SG&A grew million second investment supported driven the XX expansion. the $XXX well XX% of XX ongoing move readouts data our thoughtful

our reflected was ongoing XX%, manufacturing product margin quarter and start-up gross facility. costs Second fill/finish for net sales which approximately

approximately less the $X.X Now to generated approximately through XXXX X the and and the million debt flow in of cash quarter ended had end marketable quarter. of securities of $XX.X $XXX our with sheet. repurchases We approximately X billion first as cash of free first flow and billion. through balance repurchased the for months available the the the Regeneron of year and billion months of cash approximately shares $X.X second

our Finally, year full we minor XXXX have made guidance. financial some changes to

specific have expect well gross and We guidance costs primarily morning. near our start-up in be facility. positioned to product non-product margin as XX%, guidance results available our this release our summary, XXXX earlier of delivered the for A reflecting the drive approximately to margin including mix Regeneron gross summary costs, complete updated press outstanding full long anticipated to well fill/finish In now changes as and in in term. in our year second continue growth latest quarter is is issued and higher

pass the back that, I'll to Ryan. With call

you, This Chris. our concludes Thank remarks. prepared

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

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

on the quarter. great Congratulations

I'm the that quarter-over-quarter. EYLEA and to the overall maintained the Regarding franchise really share up see year-over-year is category is that XX% encouraged franchise,

launch, quarters the stable will market reaching overall year-over-year? and stage still category of in you and retinal share growth that that participate So allow EYLEA coming XX% a where its to believe HD maturity the growing the around will allow do disease be market in the it relatively you is to is

Marion.

couple it take you I'll pieces. Thank Tyler, So question. for in a of the

the to we total to pleased in year-over-year. I excuse did billion you $X.XX the a as Obviously, X.X First, mentioned, me, net comment, -- of X.X% that's sales report quarter. want increase were very

competitive is sales sales. prior we that very And EYLEA more million quarter, market. reporting this bit net the in little XX% we're launch increase $XXX are full had our HD. certainly Additionally, very in on from And the net results in today. that encouraged increase third a is which certainly, just This that certainly, I'll stage. we're of quarter, much We represents a significant in the comment quarter calculation

our launch see are progress for So an patients certainly, continuing is important we is switch important. Certainly, EYLEA of HD. and it source to EYLEA

also Next, pleased patient naive Avastin, we as that population. of seeing we're EYLEA very increased coming in report faricimab, switches quarter this well use from HD to see

certainly see in profile this indicative that all standard EYLEA So care. to has new the of and the all, be HD we potential the

I also about think overall growth. you asked me market growth, market

Let me on is cover would that say the cited in this as probably the opposed I midrange digit, was we're at growth more well. category as the to double year, tracking in single-digit stage in question. think your what which in I

That's right.

you, Thank Marion. Okay.

the move to Let's question please. next

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

controversial, the Congrats had on of leptin specifically walk Can the progress. been other doing on of of this work Lilly I obesity top and I trials. But leptin. kind Tirzepatide is why that versus earlier you flag through add of saw touch that a in some want II? to Phase want you using your a moving just know to some me some to clearly, do the in of, with data trials. you interesting this rationale on say,

you is very and levels those leptin we leptin providing drop patients And each. doesn't patients be in where because are individual of into saturating. results loss, undergo the may in Once that weight high levels leptin I to based leptin creating going fat have signal, other Well, that work getting are that's is weight of the that and obesity believe the the their an about you're is a programs. X leptin a They're in combination different already range a desire who which loss have high. the obese agent. suggest degree normal of now is increased the number forward on the in in with on in reason talking profound profile, fact you upswing their

in loss leptin, behavior. may the driving the so limited that by feeding And in weight is which these decreases is increasing be type then patients, it of some of

and -- actually where least at role. be an be in the to might important it's playing be animal might leptin this been So shown studies situation

studies out, stably leptin in saturated historical in So leptin as and point benefit. obese have patients, giving you already may a is not more

are leptin. in But levels other the setting these falling obtained that on there leptin top with where lead drive levels, allow in food-seeking and at part partnership a leptin drops loss the may that plateau done as these least to point, giving And may based weight these are settings low a which in to tend driven of agents, certain these further falling on and may you with animal in studies leptin a that know, collaboration and at Lilly. by studies, with plateau be in

So collaboration studying there -- so it in with their Tirzepatide. agent we're

Thanks, George.

to the next move Let's question.

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

the little of docs third-party position maybe quarter if as you're confident they're your for the with how therapies, feedback that's progress. Congratulations much launch for the also facility on out and and there in there linvo, some all on the slide? the you existing the there, you a more efficacy to could On it getting you how prepare curious and I'm potential bit that cited elaborate administration advantages resolved. the And appreciation on relative may issues is

term. BCMA are Marion, might about and issue space. George filler a take I'll and people approach across can and been in the longer lot type where the it the fit manufacturing issues with There's our biopharmaceutical third-party lots of -- and cover third-party thinking of how a CRLs

the year was of we needed is some to we've where for we is based the necessary, reinspection what is the nature remediated, the As observations, be a told the been know, remediated. believe, was of on because a observations observations had but our with different that observation found they case product. inspecting have this you a And HD EYLEA and FDA X filler last been

get done, get industry-wide date. reinspection is might not it in called why for done not of our an issue. to since PDUFA But required, a there's attention it's likely This that. your to we That's kind time

Marion, FDA hearing as working see this FDA do you fact, a these on public expeditious how resolve can priority some or of the with we in sorts is having is, application of things. We're this possible. in to these. sort think I to cover manner review planning George want the because this

and survival to continues field patients it and have then progress But I'll summarize our as efficacy with as to numbers. deeper like it they the believe, data to start continue we PFS and detailed we now we'll response and Yes, deeper leading data look matures, continue best-in-class and hand the we rates complete and to where Marion. over we've responses presented, to as treatment, and at is I'll overall XX% be bispecific continue the with, on type

about because eliminate and and important cancer that what this we is patients focused to what our the survival in physicians really our the and believe, And are of getting profile, This in burden trying schedule of imagine exactly obviously long-term also believe would safety terms treatment about and cancer is is best-in-class. durable is other also, all responses patients. we aspects hospitalization and we are dosing

physician Marion to ask Marion I'll In believes how terms of the comment on data, is community that. appreciating the

Thanks, And approval we're differentiated about physicians. George. be certainly, for upcoming linvoseltamab. the efficacy, important profile the George potential will excited that very incredibly safety describes clinical to

and hematology highly a experienced in team have for launch. ready place We

ourselves, to would just we're last would -- just that add the is I obviously, line. I just add this Yes, Len. not limiting

rule you last amount to move early just remarkable in of The the has But in in this line. this given either tend move you seeing lines. much responses what you be to told cancer lines about We been are in of therapy. more George responses trying would monotherapy the thumb combinations aggressively that or to earlier quite as get we're to of

updated forward as moving that. and excited -- we'll So do you very go we we'll we're about this keep

Yes.

of in Just follow-up we're results Obviously, get those be is trials clinical said, won't why obviously, this moving the we to areas those these lines on from we until trial. commercializing a Len therapy. earlier these

go Right. the Then to next let's question.

of comes ISI. Evercore question Kasimov from Cory the next line Our with

on increasing interest you'll an getting key we're X So amount the your your focused antibodies? probably XI differences, speak aspects you Factor know readouts inbound I program. be will of what George between to in in upcoming Can right on your the you're the And be track? guess, for to

Yes.

which our developed inhibiting at have of what the the it in mechanism class amount domain is best-in-class classes, part best catalytic signs, we've so both of affects genetics only that action. split will Regeneron the a separate genetics allow antibodies optimum efficacy domain, and approaches So efforts optimize very of the we've importantly, done optimum the antibodies, these all type of other that suggests these that the or X activation we based are the on created us actually and to ones in hitting forth, by of and in target fortified own safety. and One huge

primary quite and move in forward others target some of it's might most actually both is where for the we where these might efficacy that be safety So populations with which important. of driver possible different antibodies

also mechanisms or So the but can powerfully they're very their target action, of that much X do They exploring than these action. of in precisely the of mechanism more more by other splitting that unique really antibodies are this both have things. competitors

So very excited we're these programs. about

or may said, both we some by hope and going end ongoing, the forward to directions year the of be be future. either As the the of we taking have in we we antibodies announce these to able proof-of-concept studies

Thanks, George.

Let's question, Shannon. the please, to move next

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

EYLEA and commercial question the quick on a progress. just And

sort of you example. to remain change But dynamic with kind you about some can that sort specifically access Medicare as how respect talk think, I'm guys, going we've barriers cetera, seen curious J-code et that plans. is playing their the were we were on permanent Advantage I J-code. market really see permanent some pretty post see discounting, gotten was even clear the in other with you when maybe among inflection of out such permanent and things with they VABYSMO access your feedback So and that on with variables if as messaging an J-code the got there Marion, should not there J-code of

very very, Sure. comment. I'm to happy

way So certainly, If where fee-for-service EYLEA that for of market, impact, a physicians. there's over XX% portion for the go to of freedom successfully and teams covers of those there's the HD areas open patients, for a Medicare access prescribing of in a lives. have our opened payer patient market we access

where managed certainly, management step some through I those So often are having been share physicians has that work might made, be when utilization easily progress continue and significant situations to or will we where office market very EYLEA HD the message strong the in should XX% reimbursement information. that has be But place. provide takeaway overall, of And staff the physician a again, coverage. payer and is edits

Thanks, Marion.

question, Shannon. Let's the move to next

line next with of Akash from Tewari comes Jefferies. the Our question

This for is on Kathy Akash.

like using combination versus Phase up that program, in which So stack versus for for your muscle where approaches, triplet versus combination myostatin you your loss. preference your approach could can do plus amulin And also, about myostatin XX% talk a show doublet III trials? will potentially you think

important focused the reagents best again, us allow dissect which creating most once Well, and individual to are what Yes. on is that players. separate out the pathway we

people, not that and others other -- known of side variety the that aware, an using that effects. for are pathways, adverse the example, potential a have know are all and irrelevant antibody and to are we've about blocks targeted, you're XX muscle we but may As for other only X effects

efficacy determine mechanism. specific want And the believe X which So have either both muscle in with we what Once that we we targeted this is we important. we is do see to X antibodies the of that or whichever the forward that, single to with attack X pipeline, best to a to pathways whole of very variety may weight addition molecule combination a want might move have safety weight to in agents pathway. we in we these loss loss will in developing multiple been X allow solutions or our the these of pathways unimolecular also profile

can loss inevitably you agonist, pathways of can and we use, with necessity loss choose these just of on that weight why, because the a pathway that by the throw on on to to pathways. very matter as of of activation mimicking dissecting antagonist, allow can the it's you're because to additional GPR The unimolecular of throw leads what GLP-X rate of possible, you ticketed pathway more out is between remember, you what because hoping and do more to pathway, amplifying starvation loss have is rapidly the precisely on. lay because want, us So follow That it patients muscle which can occurs, weight regardless we're you not the more loss, at. as scientifically the we're looking said, solutions

X right on profound loss, loss conserved rapidly because lean invoking profound that amount we you result accompany's will these necessity evolutionary approach do weight which these can conserved specific rapid the of pathways, it by into patients huge block muscle loss, also obese fat evolutionarily increasing may a pathways causing focuses detriment muscle older plugs perhaps these now the to loss able this what body especially to and in which want while that blocking be associated necessarily So may necessity weight of things. and specifically We loss be any agents to of is will And patient. lose.

to pathways precisely studies these nonhuman pathway ones important, is can not dissect incredibly is and are embarking in these safest humans loss, them preclinical pertain properly the the tell best are what right the only we've who fat pathways, And benefit the that primates which while give we'll to decide not conserved shown but best, optimize believe and to should now whether now exactly will on us all evolutionarily what's in the really the patient. This we loss only through we're which including to interrogating we on able indeed muscle. maintaining studies, be whether weight and of optimize the we're that's particularly

Thanks, George. Shannon, question, next Okay. please.

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

exciting food and that or allergy this percent us it's appropriate number later where of early see if a with of supports forward to food treatment going and this bit be could an DUPIXENT Can linvo, you allergy. know program. just out think you those we patients forward? on frame help I Just the combination data year but the an moving

them a of safely of back cells to the this these based then of programs said in the again. as I've may -- all We once eliminating these the all the world's profile that actual biologics, to we DUPIXENT. X have going by other most that it's that are and very on think safe And focusing shown, what keep all allergic giving safe which responses that historically I risk coming very is is data on. be way a benefit causing from believe, we're we've matter

. prove to have we course, in patients. this Of

of allergy in if already And safer other for so effective a undertaking we example, ultimately, from have is, for can all their safe need, The very these also patients so most the population of patients it prove the really it severe of but more more then are forth, they we unmet starting in particularly, allergy be And where patients. risks approach. inducing these and some in indicated have, and are the we broader the rebound. food fact, suffering is high very this then it may cells very high warrants And way most diseases, preventing can eliminating remember, go. allergic And DUPIXENT. them importantly,

almost biologic may which and to you're been quite be So drug milder may of be giving be allergy them We a helping anyway and go into patients. goes. safe as has them in milder actually able any terms shown to

with essentially this the most patients of profile both types high milder milder we we and So how approach can patients but with mundane, whether safe safer patients depends eliminate is, these most is and wider the you and the initial actually benefit no and the And allergies, in a and ultimately to it we're also disease. safety, the on limited taking from food-allergic for initial a very risk it the to all is but effective and unmet studies, also high have to broaden starting most need unmet severe can high start are we what to the we're safe food need we be risk need, in can depending serious broaden There's who and it is on goes severe studies. we're there, the seeing it can how these wider. most allergies which very testing

I mean the get staggering. quite numbers

very is look a got induction says, of to safe you exactly millions to at million of a thousands induce But food-based just all Dupi approaching in of the emergency could it of is the we've hundreds the smaller can a be agent, number reinforce you get go the emergency to if number drug. allergies. Dupi, people on thousands, -- at of and what hundreds of if room visits Looking on George Obviously, just year, for for anaphylaxis. to patients actual process BCMA takes where an it

drug. of profile that know we So the

makes So We how see just this have develops. all it great scientific take safely sense. and time, it our is do to

George. and Thanks, Len

Let's move next to Shannon. please, the question,

Our of next Wolfe Anderson the question with comes Tim line from Research.

an assert specifically I have you that you interim in on out that Claims its Act. the resulted investigation a "other April. kind And that prescribers. of Slide just on provide because and question X, Regeneron happens DOJ April, on wondering the impact practices and mentioned marketing asked the am emerged dynamics they the about what into lower on update of since where guys here, practices EYLEA Can violate since False from market marketing in is volumes I price". any I lower even any having it. you prudence, changed has that of and

of our fight practice, get you a this nothing better much lawsuit. And There's to we And we frankly, this lawsuit. in have And to it there's nothing in that. marketplace vigorously. to court, papers the intend you'll our not I related think changed see we once understanding think and

question, move next the to Let's please.

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

Yes.

not Regeneron outside that really work. a it's obviously there's substantial but R&D tremendous the also to is company a tremendous of happening leader, company, sheet and innovation the So has putting balance

so, eye So is, blockbuster eye for to acquiring an near disease to in term if disease. commercial the severe And medium therapies is presence see opportunity any question potential to Regeneron's novel by leverage so? does there my company opportunities do the

some great day to from there opportunity should X acquire. own our -- we resulting here. innovation it's and Is we Yes, trying that we it's ask a be that question, isn't are every

of capabilities, such scale products think We there's but -- kind any we've about, we of or we whether a any done something millions research at for. and our in-line hundreds products or could million moment have an that the certainly and we it's late-stage we some smaller see scale. of nothing for leverage of opportunity or large Obviously, few not numbers not would seen

Thanks, Len.

next question the to move Shannon. Let's please,

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

opportunity potential the the the could plans you speak future look and XI On Factor to programs development what here? commercial that like here, are represented

Factor of attacking X that Well, classes different evaluating as pathway in we're said, antibodies stages our in I the of X ways. this XI are

already about. I expect think We we've talked

slightly potentially with profiles. more them of clog will effective but preventing be effect side serious more come One formation, at

might much was attacking, other important that X parts. be we X using less thought The safer. And antibodies I really said, precisely interrogate different to are effective, it pathway these but as this

domains, So we has expect by each best-in-class catalytic antibody. different blocking independently a this is X different X enzyme. It the And activation deliver domain. an to domain, with X to profiles X

will understand might clog where into more but not we for is can those more you the Once and or which be as both understand X effective directions antibodies. less higher-risk important. forward, we X potentially settings in profiles, in imagine We safety really to taken prevention easily want taking patients, say, one, effective either let's the

get take to the by to going they these the out now this as to are for better on and this of define that all there and them is agents profiles. direction year, said, which So data of the compare which safety end our profile various should depend indication. to hope we how and that key efficacy I existing And

there's So and still distinct be. formation. take what will here clot to X understand initial profiles to them our where hope and block, thrombus agents from need there, opportunity we understand X can obviously, we'll antibodies, better based And for them proof-of-concept ultimate that study. on But the enormous

profiles. and depends opportunity X very distinct excited so here, safety on profiles having these much very but about we're And to the related have

here. safety a market market. with bring market, to market. is bit if a the direct have a billion efficacy, It's you profile oral amplify large big said very part most of that a some $XX similar George really about to of anticoagulant what very, that but a Just fragment you or of opportunity market better could little then

be or give large if George can that, able of on. proper patients a opportunity. the was but give as better antibody what then with really a profile. If we safety X have market sort with deliver that's can So will or we we other suggesting we Can better big same efficacy we're a setting, in the focusing you that, to

many profile, are of certain because which could the use whole as safety there opportunities settings And new don't where agents create you well.

you. Thank

Let's the move to question, next Shannon.

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

having commentary would near-term high I that disrupted Congrats appreciated. VABYSMO pre-filled relative your on disadvantage Marion on appreciate to the from if the wanted effort, specificity by the just I more you momentum the and own time Len for on won't dose but that the confidence of give earlier pre-filled syringe, launch be lines, a team, guess, quarter. be syringe the the

a actually launch for of said Well, remarks early about not they that XXXX. launch to part of but I'm we're months, do a anticipating competition in my prepared I think ahead is matter I launching, the if a sure in think, us. going I what

think, I the drug, profile that's don't so safety of marketplace with impact think people where going of that, I to significant really the focused, the in experience had they've on the And a ingredient. have the aflibercept, are our durability drug, active our

in pretty launch. feel we the ongoing confident So

Thank you.

more for have time We please, X questions, Shannon.

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

This on is Terence. for Chris

HD. Just us about EYLEA X question from

second in for half of XQ. the in should have How the you market think what pace Given about conversion we of seen the XXXX. dynamics

any You there. should hard about That's know to think comment job. wants I it. don't have Marion your if

progress that very launch. I EYLEA HD we're commented pleased the I would as our earlier, in just say in

you. Thank right. All

question, final the to Shannon. please, move Let's

Mohit Our Bansal Wells last question is from Fargo. of line with the

HD. just I talk about want again, to, EYLEA

comment innings In as think I you're patient forward? we point, the think of most as versus versus how point in when then switch a of much and we from dynamics of EYLEA access Or conversion? pricing about going there do are as going EYLEA the you well early think view should forward, think the standard HD treat do you on, is at other difficult Marion, this terms patients them if is some model -- in you of to naive assume could switch adjustment? And versus is you they about beginning?

of So it's EYLEA HD then, switch combination of course, and a of naive patients. always initiation for patients

comes prior quarter, third encouraging category, because that in be source the else. which today And profile the mentioned would the utilization from from quarter. then then what's it's EYLEA from secondarily as So to I'd the of switch not Avastin and treatment-naive the there's switch EYLEA HD, patients very product the patients faricimab. among largest mentioned surprisingly the is I everything But in patients encouraging, is really doubled of

to is continue every evolution combination we'll So see EYLEA in if right it's profile does category, very an the but the HD progressing got well. as the potentially, to prescribing product of ongoing

that Marion, did who Thanks, not Q&A and thanks hear dialed for interest chance we to have have from. not those remaining everyone Regeneron. a in did apologize to -- a today your in that chance to the in We queue

always, to may and Thank is remaining day. have answer questions have. great once you As a team the you that available any IR again,

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

disconnect. now may You