Regeneron Pharmaceuticals (REGN) 4 Feb 222021 Q4 Earnings call transcript

Welcome to the Regeneron Pharmaceuticals Fourth Quarter 2021 Earnings Conference Call. My name is Michelle, 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 of Hudson, now Relations. Investor will call Mark over Director I

begin. may You

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

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

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

of Thanks, Mark, year joining and capped off The terrific fourth XXXX everyone Regeneron. today's call. thanks to quarter for a

the a strong testament line business. COVID-XX. important organization, across our who performance despite to Throughout strong excluding our driven the We're XX%, Our work diversified by continuously execution growth. proud core cocktail, challenges our was antibody and on by strengthening medicines of to all patients COVID need. bring Revenues, top of dedication novel breakthroughs in the employees mission XXXX, delivered deliver we bottom grew medical of our and incredible posed ongoing and and

world-class wide of across and variety diseases. advanced innovative Our pipeline a

and potential to data We also Genetics significant the unveiled medicines unlock Regeneron initial from portfolio, has clinical value. which pipeline advancements our long-term

In to billion of $X.X spent share shareholders buybacks. we repurchasing cash shares. the substantial 'XX, returned in over million X approximately we Additionally, form

high-dose continue to of our In significant new those on global and program. transforming on future look and year, the our For has an provides results half the entries. Even to opportunity, of that after goal potential market sales EYLEA, type market X efficacy, enduring the If XX representing the and the Phase grew to years X treatment aflibercept retinal delivering later, we from $X.X product, forward of milligrams of enhance on global year. to despite duration XXXX inflammatory III to compromising $X.X we continue injections for as of data aflibercept the X-milligram milligrams XX% view extended millions dosing diseases. second sales Dupixent billion. we the safety XXXX support XX% aflibercept complement EYLEA franchise. were growth without X a Dupixent, are With billion, with

growth. penetration indications, Dupixent's of a we ahead, There opportunities and further in are rates launches of in outlook Looking in to forward population market Dupixent's chemotherapy approved non-melanoma skin broader year approval are potential the of wave in non-small new significant the Libtayo thrive cancers. In to cancer is indications, continues lung to midst this potential new Libtayo submissions and plus bright. look increase approved patients. cell the in fueling oncology, data We later

Our oncology to footprint continues expand.

This cancers, combinations candidates groundbreaking with bispecifics the many settings. hope We of and into clinic we in ovarian to and solid as both year, sharing what response forward have look cancers rates will tumors, of conditions across which immunotherapy. are low we prostate advanced many to historically cancer a difficult-to-treat co-stimulatory bispecifics be and data range antibodies, such with

remain also CDX in our progress We encouraged maturing the bispecifics. of

CDXXxCDX bispecific. confident We profile overall are odronextamab, safety the and in for efficacy our

recently least, COVID-XX. its play in active the on the variant which FDA amended of during Appropriately, to globally, but preclinical ahead the people competitive against will We pandemic. the helping treatment the given variant. the REGEN-COV, REGEN-COV, antibody bispecific, with efforts limiting Last major is are COVID-XX REGNXXXX, we its cocktail, the rapid proud of are In Omicron against that authorization the forging remains unlikely being for emergency administered fight committed use highly announced use light Regeneron REGEN-COV multiple in be active to darkest of impact the myeloma XXXX, was days dominant. to we believe of millions a Based U.S. an of pandemic. Omicron data, our response we making our not profile. immensely in our role BCMAxCDX

Delta progressing and are against We that variants concern. of active next-generation other antibodies Omicron, are

scaling we and closely necessary up regulatory completing and additional as and the collaboratively candidate FDA to options to coming clinical to with begin clinical manufacturing patients the trials working global are next-generation treatment efforts for antibody bring quickly and are safe authorities requirements to and months. define effective as establish other in the monoclonal We pathways Concurrently, possible.

As one to platform the deliver fight against COVID-XX, potentially uniquely technologies develop us life-saving of of leaders positioned in and our the makes medicines. VelociSuite promptly

remain from story adequately vaccines. not a prevention to COVID-XX the we for there respond our transforms opportunity who those As monoclonals significant believe as do will next-generation individuals COVID-XX endemic, use to immunocompromised to pandemic a

in discovery In and through conclusion, XXXX infected play Regeneron. for marketed high-performance antibody is billion individuals. firing role was XX-plus treatment over for positioned portfolio the marketable an a clinical monoclonal another external With addition, Regeneron in efforts from strong In growing therapy trials, for pipeline results strong likely is highly on cylinders, securities, progressing productive in-line $XX to of collaborations products, cash candidates and our ongoing all year extremely our position with financial future. our well commercial

Now turn the call over George. will I to

Thanks, Len. antibodies I'll monoclonal start by briefly addressing our for novel COVID-XX.

thus, antibody Early variants of Omicron we that retain both virus VelocImmune other anticipated are human potency rapidly from candidates against and Len mice. As pools next-generation mutate antibodies virus-neutralizing XXXX, the began our in we survivors and, concern. would developing of that large and generating mentioned,

studies, We're variants pool the based first on track now We have next-generation trials in clinical neutralize and with candidates these the to concern. and of effectively that, this of months. have preclinical and continually evaluated Omicron other initiate on coming refreshed

considering future monoclonal streamline with In antibodies, in development how potential regarding mind. in the unwavering for discussions demand variants especially and virus to with addition, program the these we are for the unmet need FDA medicines,

As the in people especially Len this will alone, the role to several a continue million development future immunocompromised make future. we monoclonal in pathway highlighted, United play in to States of that important treatment are that already near the antibodies protection of since the we possible believe committed will undertaking an

over the Angiogenesis same currently to Phase on study, more AMD. numerically this us given potential dose. study and endpoint, X-milligram patients the we with with the from aflibercept II present a readouts data X higher show EYLEA convenient meeting, approved wet upcoming safety results at aflibercept its more At in efficacy but dose In protocol-specified III of Phase met aflibercept will safety the II EYLEA, match dosing favoring as the has -- schedule, Phase to CANDELA dose these that the the X-milligram final that X-milligram give Moving X-milligram X-milligram of milligram, the the measures primary upcoming can with least ophthalmology. two confidence drawing These at dosing.

the met across such demonstrate Dupixent primary the Dupixent. to III XX% met primary endpoint and the has only placebo indication. experienced disease marks Dupixent nodularis skin the trial, pathways reduced of results so lesions has XX% shown as for inflammatory on the Nearly the and by success data compared allergic X demonstrated are convincing of XX diseases. well. underlying inflammation type at this patients key study providing far to Dupixent in evidence a its Phase the systemic second wide to making drivers success to prurigo confirm the that Dupixent which Building compared patients of These Phase the III Moving Prurigo endpoints, from recently clinical or of Dupixent outstanding IL-X of and the spectrum first diseases, reduction all nodularis in key Xx of many Dupixent patients X first where benefit type these medicine inhibited on IL-XX weeks. sixth placebo profound for patients, secondary

patients the spontaneous other disease, pivotal the Dupixent patients. conditions, to how a results the or profile, share and benefit on clinical At or of appreciate are the AAAAI EOE, how many Dupixent it to in chronic will for promise delivering story is set we present top excited is complex highlights the its across meeting, in eosinophilic upcoming addition EOE and we studies provides a with study. the is its to in scientific the first data of terms with pipeline line providing the a this diverse well-established for Dupixent for and have recent safety important of community important product. CSU esophagitis, remarkable these and together We in urticaria, updates,

flow EOE first update prurigo submissions underway, first continues. also submission year. data nodularis adults clinical the Anticipated Our regulatory and in of for Dupixent-related of starting half for adolescents regulatory is this with in

patients and in or half of bar urticaria on pivotal patients a for this are chronic for and CSU These results planning study We indication of Dupixent. also forward studies. the the more present omalizumab looking these an cold-induced in in second experienced represents condition in additional We're this year. reporting time difficult-to-treat to Phase higher results III

Moving an as well as anticipated multiple oncology portfolio entrants. and regulatory pipeline first Libtayo. and novel Libtayo readouts oncology for milestones our data upcoming on filings in diversified bispecifics pivotal for includes to Progress presented our readouts with

lung with Society BCMAxCDX cell the of lung non-small potential grade As the Len no with data Libtayo shown a has our with encouraging combination be patients FDA portion to larger strong hematology, our competitive agent for is in REGNXXXX, at PDUFA and mentioned, XXXX, under September X date or this at to data. of a In chemotherapy release refractory bispecific, the which investigational review relapsed American is indication. safety syndrome for cancer promising We XX, date of Annual patients with data that we or Hematology efficacy Meeting, cytokine believe presented has multiple investigated for myeloma, the higher and address could cancer. the

combination bispecific, for for with responses. for cytokine on efficacy co-stimulatory safety care, planning of mitigate need may large combination are our bispecific, We of best-in-class hospitalizations this both with B-cell myeloma and profile the standard updated and and lymphoma lines decrease further therapy, product enhance follicular dosing manage Odronextamab, CDXXxCDX in diffuse release could excited step-up has in are an a which the concerns appropriate earlier about our syndrome. the and to protocol potential lymphoma, investigating

previously of later In we cancer, activity early these excited developed this disclosed, solid our for and progress observing early are for of signs bispecific our for bispecifics late-stage to data year. ovarian are MUCXXxCDX of as monotherapy tumors, terms sharing we be

initial a in in a that bispecific well of bispecific Early Libtayo in with Later METXMET MET we clinical naked the patients studied are in follow-on with MUCXXxCDX a early non-small protein first in agents, investigated antibody bode enrolling trial conjugate, in year, unique of MET for cancer activity antibody, alterations. especially patients so a combination with bispecific drug for observed bispecific. biparatopic its METXMET METXMET are hoping addition stages the advancing share signs in These advanced combinations antibody we this study. MUCXXxCDXX combination through Phase far our is with overexpression, now monotherapy, kind a with In I are to is which have to dose results being patients escalations. cell and the

excited for bispecific about EGFRxCDXX early-stage also program our and lung co-stimulatory cancers. are other We

from co-stimulatory are year escalation as dose bispecific initial cancer, PSMAxCDXX is in through with our progressing readouts we prostate well. Libtayo. this expecting For later first PSMAxCDXX combination

combination We I, are which going are includes beginning to our II to of potential multiple assets, the III in the about and immunotherapy scale groundbreaking broad collaborators agents. Genetic strides the and medicines. oncology the believe expanding involve Concluding Regeneron genetics our our excited portfolio, targeted medicines right of our significant is in capabilities work made we future efforts, many of as with have Phase and

our Alnylam, patients is NASH by year. are anticipated data in ALN-HSD healthy middle progressing of collaboration volunteers, with terms and this In siRNA of the through initial

for the tested supportive investigational RNAi standard presented results or submission planning antibody announced recently were also of at of another in care therapies, the agent well PNH, monthly studies for for siRNA by the switch Alzheimer's Alnylam cerebral demonstrating Recall, and its first-ever relatively the protein, subcutaneous data and be and eculizumab. Phase against for diseases. amyloid or III as regimen CX Also application dosing therapeutic of and combination, CNS disease. as early-onset including ALN-APP, precursor has the industry's studies. in of ravulizumab both PK This CAA, CTA healthy patients in nocturnal first will disease of as test in PD With ASH, evaluated both were known our kind, rare angiopathy, the PNH, amyloid selected naive are we the combination pivotal initiated. hemoglobinuria, combination paroxysmal to volunteer driven

-- data quarter, the study. TTR I arm clinical include will polyneuropathy CRISPR-based Finally, will interim later update amyloidosis. on ongoing Phase transthyretin ascending an knockout we XXXX this our and our the of provide Intellia joint from dose for program This additional Intellia

even transthyretin patient believe expanded amyloidosis we have population. will study broader cardiomyopathy, which patients the an include with We also to with address

from our very and the with Decibel. CRISPR-based eye, are our advancing are with We brain as gene as liver, by ranging excited delivery that such Intellia collaboration diverse with we the pipeline in programs, of and Alnylam, viral-targeted well and large siRNA candidates the targeting approaches as our

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

Thank you, George.

record flexibility for Our billion to is retinal We years XX more favorable and is recently due that remains quarter efficacy, million demographic with injections recognized experience, indications launch. fourth for grow continues brand and choice commercial in demonstrated for a of with to physicians' a administered performance approved EYLEA top the our leader due sales patients to as than brands in and unsurpassed we for category prepare business real-world EYLEA a the safety, net the represented success post all worldwide. indicated launches. in-line diseases its reached XX resilience share future demonstrated dosing with across XXXX. trends. $X.XX and year, strength fourth quarter U.S. creates noteworthy $X.XX Starting billion which EYLEA. XX% and for foundation growth of announced This year-over-year U.S. full

initiatives existing also strategic that for efforts they as future are franchise receive our about where don't many excited in retinal We indications such need. treatment patients place the position educational our growth, across ongoing

Beyond EYLEA, if by promising results diseases. for potentially of treatment III eye by high-dose a milligram, we encouraged for aflibercept next-generation are clinical represents early Phase range which, results, X supported

Libtayo market continued Libtayo patients making growth as carcinoma, are being the hedgehog In also And a is than reached would have prescriber cell in $XXX advanced cancer, inappropriate systemic recovery. inhibitors, combination cancer who in launch also saw carcinoma, sales cutaneous of treatment, the strength progressed $XX monotherapy majority Libtayo, if established Libtayo of where is In steady lung progress our setting. non-melanoma patients million, or net fourth we for basal drives alone. much building its cell Turning for significant rapidly care with are advanced proved, U.S., is advanced which first-line broader as for in the growing steadily base. squamous performance, net monotherapy in global opportunity chemotherapy standard our of in currently the range be #X available sales lung of to There on quarter In in indication the non-small were million. and post-COVID cancers. a skin the cell we

our consider with that patients, first much cancer of Libtayo Our in successfully standard care. group to launched HoFH, of medical smaller Briefly reserve franchise. is and which, monotherapy already was oncologists experience treatment patients the part, treatment lung a has cardiovascular limited combination in XXXX for in date. and is Evkeeza, to our uptake for turning

with age and across new of dermatitis, into geographies of atopic moderate with fourth competitive In employing approved patients from atopic XXXX, both expansion Dupixent with are years prescribing label an of based prurigo disease and the new global progressing as $X.XX systemic areas, polyps, the initiations well continue that profile, net to biologic as treatment are strong allows as switch on On year-over-year anticipated in also grew is young the urticaria of specialists' care spectrum first-line are health business. the in young to trends Dupixent's is chronic innovative category may billion, need asthma prior ongoing even chronic estimate new as groups in U.S. which dual In younger to and severe dermatitis with space. in nodularis, we positioned preferred differentiating We grew patients. forward disease. naive approximately quarter XX% help competitive currently on HoFH. and alone. anti-IL-X choice to six XX,XXX identify in relief, use net to There well severe uncontrolled in worldwide. safety due benefit spontaneous efforts efficacy important potential see approved, We including to to well-established in steadily indications. XX% Dupixent immunosuppression $X.XX focused Dupixent, where unmet indications disease in action, no mechanism the we diagnosed allergists skin sales symptom serious highly to with and and children nasal no to billion. through rapid the expanding young rhinosinusitis differentiate children use babies is and to for profile, dermatologic several Dupixent months. of for we age. to U.S., data risk is We're of as not ongoing in of compelling and opportunity patients. IL-XX clinical infections meaningfully existing sales also growth regardless two rapid significant and patients currently due in Dupixent growing as characteristics, product to six Dupixent its look surgery highly include If patients well eosinophil its as steroid-dependent moderate treatment to broad see ENTs of to in our their as contributes also levels, including a regardless in potential patients, medicines Dupixent

We from launch esophagitis, are across commercial of delivered Dupixent opinion received disease. positive strong serious progressing gastrointestinal of key least if data treatment XXXX, estimate at for growth from the feedback We team portfolio. unmet also our We've XX,XXX eosinophilic the lack leaders need. in disease patients approved. our on summary, this with benefit and the alternatives could strength our suitable U.S. a plans in substantial for In

the growth. launch future well position and us momentum for Our opportunities new

to Bob. Now the over call I'll turn

applicable. quarter capped revenue $X and billion. comments quarter, results on Regeneron's core business. off delivered strong driven line financial non-GAAP quarter year. basis within to fourth top year-over-year by grew our My today a Marion. bottom execution total growth Thanks, In a be the Fourth XXX% will where outlook we strong and Regeneron's on

continuing business. the income quarter related of $X.X the revenue revenues of of related with government delivered collaboration our net $X.X to COVID-XX billion, U.S. $X.X Starting XX% quarter $XX.XX with of in share REGEN-COV. a to net global quarter, each to grew fourth of X.X agreement cocktail, remaining our U.S. our to billion true-up resulted demonstrating strength the was by core and recognized Roche's manufactured antibody per profits. net Fourth million products diluted doses accordance party the market billion. we the on year-over-year of amount In fourth total sales. Excluding income payment from global supply In Roche, supplied recognition share XXXX the September with total

revenue. $XXX result, million sold and Roche in we As a goods quarter, charge recorded the a of in fourth recognized cost no collaboration

supply all government the we mentioned, As U.S. in fourth the deliveries under XXXX September quarter. completed contract

profits the quarter collaboration compares expenses, was of EYLEA recorded million million, operating the now we REGEN-COV's the will emergency of XXXX. our U.S. seasonally which With net fourth authorization, profits Despite expect to first our of record to in amendment our FDA's profits we fourth not to $XXX use last was recent collaborations, million any Bayer. do of million, REGEN-COV with starting Fourth ex-U.S. higher from Sanofi move half of the sales $XXX Total constant commercialization a us for share Total the and sales Bayer $XXX X% of to which revenue in EYLEA $XXX of net by as million in $XXX were Kevzara and $XXX quarter share million, Dupixent our quarter sales a basis. growing collaboration share product was U.S. favorably on revenue quarter on XXXX from year. outside reported the Bayer currency I of of fourth reported the basis XXXX. XX% to

primarily of I to fourth Cost goods for to higher REGEN-COV to related as related spending for Moving count-related earlier, as development manufacturing related to the of $XXX and, profits primarily to due compared the slightly recognition of payment quarter the million the COVID XX% REGEN-COV cocktail. antibody expense cost XXXX million primarily their head EYLEA mentioned $XXX true-up year-over-year to share to R&D $XXX to now fourth of million and due were costs. Roche costs to sold $XXX lower initiatives operating to SG&A growth million XXXX. expenses. quarter increased on decreased

cash tax Finally, flow the now XX.X%. rate Shifting effective quarter to XXXX and the was sheet. fourth balance

a $X.X and debt remaining in fourth XXXX, exhausted of quarter billion and $X marketable the repurchased In on balance we of free And the year million billion announced November, in securities XXXX. cash repurchase Regeneron we've the authorization. the repurchase billion. Across with of XXX share generated For our $X.X quarter cash share $X.X we billion approximately flow fourth the year, both, authorization. new shares less in ended

buyers see our between and We continue we price opportunistic where dislocation to intrinsic our be valuation. stock

Now let guidance. and outlook me conclude XXXX initial our with

do earlier, to record expect mentioned U.S. I first As sales not any REGEN-COV XXXX. half the we of in

For U.S. Praluent significant throughout category pressures. XXXX, and observed competitive we

We expect these throughout for And our pressures XXXX. expense accelerate guidance. to now XXXX

the billion expense For R&D, XXXX we our $X $X.X forecast to to range of be R&D in billion.

As late-stage we programs highlighted throughout LAGX XXXX, critically development in the advance branded COVID-XX. for combination, the and antibodies important expenses development XXXX, programs comparators Libtayo are against including BCMAxCDX versus in studies advancing randomized CX next-generation to

$X.XX For XXXX. be expenses to the SG&A to our evenly the be Based initial plan, in on billion expect in spread to XXXX of SG&A forecast SG&A, our expense across range we billion. $X.XX quarters we

we COGS, forecast XX%. percentage and on our to XXXX gross of For product margin sales between net XX% product be

$XXX engine core continuing investments supported existing R&D we our growth. of well year sustainable for complete this We In the across remain morning. to to growth continues $XXX and business XX%. press conclusion, sheet, And guidance continued range our in XX% earlier issued to strengthen. full in by balance and long-term by advance be effective our available of to in strong release A rate our is With our our our driven portfolio our positioned finally, franchise. million tax growth expect of in to the range anticipate manufacturing be collaboration million Dupixent we of cost summary in XXXX

for remarks. Michelle. our that We go Michelle, to now Bob. prepared Please the ahead, like [Operator Instructions] open Q&A. concludes Thanks, call up

[Operator with Instructions] Our Evan BMO. from Seigerman question first comes

open. line Your is

we're as what this we readouts Can You touched of in on METXMET your tumor MUCXXxCDX trials elaborate oncology potentially that get a a could kind registration you inform little data be path? these or should with that to specifically solid year. pivotal how bispecifics franchise, supposed expecting to the and

would giving certainly both we've therapies. in these we these. settings, on in have signs one observing and the evaluated convincing be in then will were And late-stage who details forward those the we've inform these saw move elaborating of patients all And durable efficacy, that responses that objective presentations. essentially are how already obviously, These would future early Yes. if and be existing on being excitement evidence announced would encouraging of we these been failed

question comes from Barclays. with Our Gould next Carter

open. is line Your

Maybe I'll the on just take in elephant room. the

the very and faricimab would to pricing, love as your a about you implications their commercial about label of Marion, accommodating high-dose and what think in EYLEA thoughts as looks for context label we get like on Len and think your the franchise -- For on the positioning.

a first in details. any world label. hard Yes. But I'll of evidence dispassionately greater at ones that you interest cloned get being the for therapy see contribution can the the love out. forget, colleagues But were who and on AngX that. a notwithstanding It's see blockade. kind, Marion no People into see where that discovered you've and would we to has the as see blockade don't any faricimab scientific AngX AngX, evidence to there's transformative that a any very we value let when given really the look George and separated his nobody it of

faricimab lot a to moral is of basis relative there are Lucentis a relative We So learned here. higher of EYLEA. dose to what on possibly remind and a we're that seeing lessons here everybody

million the biggest the, is I that now One injections lessons is of XX efficacy is given that been but almost know, nothing have right EYLEA. with important, worldwide don't well And safety. super beyond contract

lot the to good. -- that of pretty from to elaborate. eat a Obviously, We take suspect into we'll Lucentis, going its of feel product. is competition but may is might we always a faricimab initially competition So want share good. The see. Marion

some and, of that opinion safety. first key And leaders met the dosing remaining market on we're is feedback, complex. very clinical that course, the Len give and to via is are questions is that from potentially design changer Certainly, early mentioned, comment Len. as product don't game there you, Thank a Yes. getting trial the see that they

and More importantly, with great EYLEA, product prefilled indications, indications more I'll where of and real-world of the syringe flexibility are go back busy dosing, standard as times. establishing experience, over care across to we certainly evidence,

and So going out. strong III we could what X-milligram very optimistic forward EYLEA, if next-generation high-dose with works to a look our data about on performance own be Phase the aflibercept forward product we're product

Buren next from Van comes question with Tyler Cowen. Our

is line open. Your

So for your coming entering next-generation clinic COVID the it's antibody cocktail, months. in -- looks like you it's the said

slight So And antibodies. FDA guidance? versus to you the referred streamlining was a prior development QX monoclonal there of delay

long in give curious take there So market? Bob to can just thoughts be it us the sales your something if first second half. the noticed mentioned latest on I half, we won't get in how so you to see that could might

George quarter can thinks the whether comment we the quarter to any end I think this clear. Yes. want next just at and or that tough we'll rolling delay, know necessary, he I we But when George some guidances comment or we're don't thus come forward. early in is exactly estimate of but on in there's we're of what and can just far. up, be the about on U.S. considerations to global start. It's scaling thereabouts. and regulatory

first-generation Yes. are to was as not to and agents the program we're add. the development mean, the vaccines developed what regulators compared to the with to was same is platform. what There's expedite done much continuing the what abilities discuss using necessary I for with programs

that update more. will we as So learn we

just you so confusion, some clarify could it. there's George,

on next-generation Omicron ahead. Our a them. Yes, go just -- work on on is work antibody of all George,

emerges as work . but that's now. Delta. the is their retain antibodies variants in against we other previous new variant, mentioned all new also of They from. the against exactly I we of select against they will They we're antibodies choose activity we that to And right before. the largest the candidate collections will variants obviously, but have candidates against And concern. what so work one Omicron, the variant a work advancing As that work my against script, of do

comment do any -- anything And on think will too? it Omicron, work stealth you there,

Obviously, Well, yes. we consideration. these take into all things

made And a we're could coming certainly against going all might when be so are well. variant have important, active that be now advancing those it that that along of looks new sure as like candidates that the to we be

Richter Goldman Our comes Salveen with next from Sachs. question

open. is line Your

that from year the what first get this do about might program. delivery programs? Could differentiated? CX you think ALN-APP we of the here see the just program you be optimization speak how and to brain how And think the going RNAi to we're I data and could to from

Okay.

about the So CNS about you're CX. the and program, but you're asking and APP asking brain always

Okay.

disappointing we there obviously, to They antibodies as have work results that to try a have decrease with all the been yes, delivered been know, with So different brain, APP levels. way. fundamentally in

they problems of syndrome One they inflammatory cause that cause, may activity. the that complicate the famous

by they different mechanisms hope the work as actually the that of is then toxic, They the efforts. siRNA it be obviously, trying mechanism. artificial allowed by cleared production rate themselves to opposed decrease letting a at it of remove to antibody may be normal they by continuously and So mechanisms APP made be normal i.e., completely will to and the programs

different. they be why that's fundamentally may So

we agent, down and cognitive going this disease faster look maybe biomarkers to in will of we're That's efficacy of disease, efficacy patients. levels for Importantly, us much amyloid diseases, in look known really so forth. over able know. importantly, we're as They're exploring ways, because albeit to Alzheimer's are to the endpoints, more may exact slowing both that types certainly biomarkers, at some and the and is the more Alzheimer's parameters in going important that years, as though rare numbers to advance but if approved ability therein, the into that only not much as also, at these why or a at next the and in for allow to proceed these results we of decline to going that's cerebral of developing smaller be, It's both CAA, And cognition there, field are the is not all be establish couple going efficacy, excited diseases. in siRNA be those angiopathy, so authorization also first disease entire quite early the the indications, important and particularly much same we get in rapidly and even definitive of but progressing, looking forth. much address

of are we targets large programs, and have going about other very CNS with these we addressing that diseases Alnylam. and So very a pipeline are forward excited we in

of us the that that also of validated genetic of brings outside So and such example, about. as, it's with in number let of eye, collaborative liver, terms in our alone the targets, targets,and you efforts the them, a part to targets include in a large important diseases CX genetically very asked eye the which for

CX. all to of we single target types as taking So approaches know, people are

can unique might Some zero. Antibodies that people antibodies you do combine an we the high by them approved large combine to to but if with these highest under existing But an levels we might and really have investigation that antibodies, an them you the sponsors, relatively so advantages and forth. because have antibody. approaches siRNA effectiveness bring incredible because, down activity frequently. essentially, of of only not There's give now the of target are those antibody, are some and relatively both, the other types have And what synergies. have of we and load, other we is all What almost these could mean? they to a give have amount realized

a are that. you of target great. target almost but zero activity, need antibodies great the of already really siRNAs to problems. the high two By putting to both. lot by now deal themselves, the that We they give creates are So and reducing you antibodies to a don't together, with best get know get load. you at load, But

of allow activity You and reduce now control load, the completely. target much to smaller antibody you a hopefully amount

we're We is to for of the best-in-class, that really convenience and dosing first subcutaneous to But potential this. think, would I moving related efficacy with also kind think programs indications This very also game for there convenient field well. other is changing with a regimen. the going be really, month, these self-administration combining there's for this also siRNA is exciting once tremendous which but antibodies. as patients. So for synergy these its and We're deliver both

bringing about we're CNS, mean, are these approach we're But and combination imagine, so franchise combining these if like bringing useful, begin CX eye, other really who them there for this like and excited really types and together in what company, but siRNA doing many benefits -- just for be area, other not of together this many of biologics with where antibody you settings company to just once very doing and many, can I changing antibodies could could in we're and just very leading and indications. the better what this are again, the So and in areas. portfolio opportunities. siRNA the And do Regeneron. than only this leading combining Alnylam and

incredible bringing some siRNA, these also about very opportunities, these with individual are we both. two technologies of together, these but excited incredible advantages So the combination the programs taking of

Our question from comes next AllianceBernstein. Ronny with Gal

line is open. Your

And long wondering It versus really to Essentially, with that to VEGF you compete market, this been a get able higher is whether you long about talk biosimilar, we've what better rate how One will dynamics practices? than And about little just when effectively -- a catch-up seems coming coming a kind for then of to year versus a talk expecting. bit code, Marion. much or the was have to online, is is bit of innovative long how be market? we're growth. contract how close to of market? this for that can take Can a to much I a market competitor little like how what compete in it the natural growth how takes different of in XX% will this J

be really enthusiasm opinion product their of on say the the to product of profile, a And take take the the confidence differentiation your I to first. is Sure. market's going based the quality have the as leaders and comes a to it it, Ronny, ability I'm going studies competitor or compete their end on happy and to key to new first that and that the of in. question would entrant

think do competitive not past year growth our the certainly, pronounced. more in also EYLEA, market of than We've case we've lot. a only and gain products, this quite captured matters the the branded the other quite overall I differentiation In captured large but growth, been points has So that last for XX% of share category. today picked is approaching up any so category. very year several in share category the our the EYLEA And of in we market XX% share

to entrants. back now Let new go me

is of timing J mentioned, in about well period of product asking a reflects and new it confidence that important. but a a six-month codes, receives how J as permanent is You're performs, product, before Quality code. it I

also earlier product of especially on for not is the product that the always with of in experience not buy is applying So concern time J-code. opposite covered, to there's on That period in which we're is my the reimbursement. I and thing There's think time, months. based but is not Ronny, in extent. hope I've reimbursement six vary a to complicated anti-VEGF will window there's The a to And with probably in growth you only experience, what comment, had confidence bill, of I going under recovery I the missed category period profile. some That most little because comparing forward. market COVID the that. product, bit

patients that treated. DME there's And those XX% exist, of took However, are those you category -- diagnosed, are are only of example about an patients and who you give the all I'll patient there XX%, patients and of XX% of demographics that only patients those of are of DME, growth those of treated. because is because are -- if only education. diagnosed with about

need make the basis of very still there been indications. as an is and tremendous Ronny. all work we through marketplace, on perform So that will sure ongoing hard to I we well hope educational certainly helps, on we that in our unmet initiatives have

product safety, a safety, millions very same now that important have injections product differences, place. there's of for is biosimilar, confidence scores with new that sensitive great thing deal that Can the to a be given learned a like threat the people have would that I along a has the the the every And of been predicted there a exists single And EYLEA. EYLEA and is variety that? number I just one of thing, seems it last a on It's add barriers EYLEA, of it's have displace decade safety think eye the the having of that way, Ronny, people there. for to next been changed. of barrier year for out most even And purported just

matter significantly to codes J time think is and of that take practices beyond displaced. of before I with it's level going meeting a confidence

next from Truist. with Karnauskas Our question Robyn comes

open. is line Your

This for is on Nicole Robyn.

option Just why Can particular Adicet quick the report, you CAR-T license towards disclosing this happened? general question CAR-T. an to on exercising and move allo their allo comment a yesterday's really on Bio just the

Could of to you was hard little hear question. question? a It end repeat the the the

Adicet? The

Yes. question? repeat But it? you was what the Can

that What's matter? the does Why of it? importance

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paradigm treatment will And the could so autologous the take really would this allogeneic the autologous and to it customization potentially to which non-autologous approach revolutionize way, take the here.

and with pretty been And long-term collaborators approach. so about excited we've we're Adicet, allogeneic this

it. And so in we're investing

Our next with Morgan comes question Matthew Harrison Stanley. from

is open. line Your

data I really start currently? just should just of to whether for data, about should know this us supposed dosing on expect we what levels, just you're in co-stim. hoping one to idea we year. about as maybe have well? some initial help And terms we're see, you efficacy Can safety or some it's thinking how to on about was I think get safety

know, That's pathway that sort led concerns very and and great field. ago we years And dramatic to unfortunately, of many question. all a safety Yes. as to, this patients, was the killed explored now

with move and FDA to concerns of this very immunotherapies, -- appropriately asked reexploring very, us very, And in add that co-stimulatory pathway the powerful other so those to of were we slowly. combination because utilization very to

are the concerning thing -- in -- dose what escalation concern study, crossed that this potentially levels, of no these endpoint it's very was we've getting I is first do ongoing endpoint, we achieved safety therapeutic think think have the recently that course, So I dose of we now think publicly hurdles. announced most in And terms and have and been that we is to potential levels. our said safety the of we we And first successfully only have that dose stopping harm. game what

mutations our And at identified, carefully example, if to And no potentially characterized setting has so characterized are for going these little program, hoping efficacy. of on essentially in of very PD-X I have or patients very except rare dose responses and in mean, properly now there immunotherapy subsets a levels, types patients. programs, now forth, we're remember, that in prostate prostate PD-X least to very we focus for rare been of these where, are that we're therapeutic for hope, at there class. so several the the

known, can patients to real think this our have with we exciting very out manner. scientists advantage essentially cancer, but any these way taking a responses I and may So out of show advantage of done believe there's it long a novel if prostate for of of take pathway have in and PD-X types a in that almost hard-to-treat co-stim in to combinations safe way and reason recalcitrant our it figured alone completely figured successfully dangerous we our that very with powerful,

responses that without be this setting see these we've So at we there this gotten previously are potentially seeing. that were game seeing to year objective is concerns now any in changing. hoping this really these that we're what levels, activating safety Essentially huge would

this this year. about you tell to able being to forward looking we're so And possibility later

next from Cory with JPMorgan. Our comes question Kasimov

Your is open. line

for preliminary Wondering getting on the data we're here program term. with update disclosure? might new if that last see near Intellia frame relative expectations we summer's your to What could you pending

the safety already far get and it But of comment up and TTR. see, the benefit we'll partner. including things some Yes. looking but of to want remarks should the at in to beyond Intellia George of our Intellia We the dose front of should kind too don't to making escalation comments. leave indicated what about have said George's the we knockdown

the is mean, CRISPR exciting with modifying cures. to this dream our genetic I almost to all whole Nobel the that's promise it points But and is modify initial together maybe colleagues, this actually is obviously, obviously, I you first-ever CRISPR of the the the these you incredibly part of mean, that's just incredible stealing one gene. systemic that patient that thunder. approach of the And duration, revolutionary. that, one hope Intellia important and Obviously, gene. prizes years, human will anybody's represents I XX case all genetic But are systemic mean, see of therapy, again, use most hopefully, obvious a with first this will And were okay? this, But the results couple not excitement have of for treat things that is the never and

of important is is, seeing we thing hope the data, one this follow-up really is the so duration, that And changing. what that be from game which course, we'll

here theory changing permanently can these their permanently You cure genes. That's by the patients.

follow for alive be so dream more appropriate whole validate the can important the longer the you could to the you And course, that and safety of duration them the with, this and up, appropriate clinical indications. continue keep new approach really game-changing

comes last from Bansal Wells with question Our Mohit Fargo.

open. line Your is

does be is Maybe that on on And provider Lucentis, are this pricing the as EYLEA? facing rumblings in for congrats could matter you combined, potential that a attractive year, products played another how of any or one faricimab. strategy your which given much seeing on progress. to also market? those has both biosimilar payer bundling take And And versus this competitor

Sure.

in own the our is, and just of to market market comes the high about strategy, appreciate But a have question. certainly, category business comment. strong I and it's it So our understanding share customers another talk I work best with the at their them probably across segments. how let level, might we closely pricing the be at When all looking company or and interest I'll

concludes IR everyone. Everyone, have. and a you here Regeneron. thanks today's The nice for That in team any Landry Thanks, day. Bob that questions call, to is take and may your conference interest have

This concludes the program.

disconnect. now may You