Regeneron Pharmaceuticals (REGN) 3 Nov 222022 Q3 Earnings call transcript

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

You begin. may

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

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

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

outstanding all-time to of last digits. as net With reaching global growing again sales to antibody the new in of thank once sales Regeneron's Thank year net EYLEA and Libtayo, quarter execution. and when excluding contributions and as cocktail. for you, U.S. from developments third strong the everyone across and commercial important our Ryan, operational today's pipeline quarter, compared revenues you Total call. well by increased momentum quarterly double our by XX% by Dupixent highlighted highs joining continued COVID

what we the ago either first did or either next visual standard treatment, potential studies is data we AfliberceptX a treatments to failing results, to of at potential issues. with year, anti-VEGF has starting patients previously in achieving already comparable care AMD I'd issued DME to treatment the the to view has nearly BLA anatomical weeks difficult review our treatment, in A across that maintenance process. believe receiving for we of with beyond treatment, With safety XX the EYLEA due demonstrate become the to mg this the review some may a planning very recently proven approval. late improvements, able the It underway, over gains visual outcomes patients. mg which frequent to pivotal of to regulatory the treatment patients decrease profile and supporting patients throughout striking XX% XX-weeks into XX-week dosing many data we not dosing were that Pre-launch have suboptimal AfliberceptX a to maintenance able that we majority We by with decade for could deeper agent of AfliberceptX current anti-VEGF were disease to our and reported, potential pivotal in like safety of investigational the believe sustain have FDA to the commercial progress ultimately approval mg plan year decided diving less priority made to expedite voucher August of shift with landscape the end review patients our able Before XXXX. paradigm, while XX% be under recent with the the assuming single through pipeline, sustain use more of mg, AfliberceptX to treatment and a our submit FDA pivotal injections, of granted wet to achieve EYLEA. September, burden transform a generation's acuity FDA

our the approval AfliberceptX addition Starting nodularis, with for in this we In now September, therapy for in indication, systemic approved. and is the fifth Dupixent which continued first FDA to Dupixent immunology prurigo received data, make and to disease oncology for pivotal notable Regeneron the immunology, in mg progress pipelines.

systemic decisions for the treatment-eligible are the looking U.S. E.U. XXX,XXX E.U. the including and therapies. atopic previously approximately as forward eosinophilic regulatory So received that as far has young expanding patients Dupixent of year, or dermatitis in approvals, in In we no two first-half year, diseases nodularis, esophagitis, prurigo months. four six regulatory patients, population next by this had FDA-approved

inflammatory XXX,XXX potential these from diseases more with With X unmatched could patients additional benefit profile. these Dupixent's indications, type clinical approximately

data obstructive in year. inducible pulmonary chronic Dupixent expect disease and of we pivotal first-half Additionally, the readouts next cold-urticaria, in for chronic

foundation We at the this and has strategy. data our as depth remarks, Society for ultimately neoadjuvant Libtayo for Fianlimab, a in were European the further importance the the our Oncology oncology particularly Medical where the antibody, underscoring presented with breadth well of review we encouraged George global datasets to Regeneron oncology, detail positioned to Annual Meeting, melanoma. of several during in Moving year's CSCC pipeline by leader. Libtayo in combination monotherapy but as LAG-X our overall Libtayo in his as results for more metastatic will become first-line

study which early note very our but as MET-altered cancer. lung a potential bispecific by non-small costimulatory monotherapy Libtayo, activity on their presented showed as poor bispecific castration-resistant with prostate with PSMAxCDXX combination treatment an patients the in in data of one in in promising have ovarian metastatic with METxMET has also our survival for results advanced be bispecific for recurrent enrolled The depending anti-tumor which combined in biparatopic our expected prognosis, to cancer, with We cell to exciting history. well Libtayo patients MUCXX our two data up cancer. for the years I'd also CDX

largely men. cancer prostate the PD-X prostate need of in In immunotherapy a has from cancer Given and over American was leading is there deaths and clear general, to inhibition cause globally in for been XXX,XXX were cancer, there unresponsive it treatments. XXXX second alone, death new

results, in first-half an continue acceleration updating enrollment forward next expand with the in efforts And We you since in to on study prostate costimulatory to our look we first August. cancer immune our program top this in bispecific reported we in of line our year.

XX% contributor Despite to $X.X bolstered approvals patient up Now States. a populations EYLEA future indications. global cancer in sales were more global and new at constant remarkable as Sanofi, Libtayo other poised across X% the billion, we in over development, indications agents and currency currency Dupixent's At compared Dupixent start year-over-year, and with the sales strong category clinical quarter, $X.XX the billion. grow entrants, up expected growth and the in all billion, diseases at to cancer globally XX% branded performance, global to with Libtayo In including lung ability only year, including set and non-melanoma treat chemotherapy recent a well XX% currency, XX% previously from to In net biosimilar cancer. for pace approved combinations net $XXX new third anti-VEGF in in of share driven monotherapy the the as and meaningful in cell more by reflecting net is constant U.S. cell indications we all inflammatory believe effectively our differentiated in become future. younger for Libtayo diseases lung quarter, X%. to growth grew to in total drive United type-X sales is at both last United EYLEA million a in by third indications all-time potentially product growth third currently EYLEA approved outperforming geographies. non-small potential high anti-VEGF at continued turning to rights and time. sales profile quarter, commercial third revenue to in growth net the category grew of to more non-small were States quarter, $X.X pipeline constant patients acquired additional the the and skin

for we as excited oncology. AfliberceptX are commercial compelling advancing we pipeline, have performance for in data We reported strong efficacy, about core the our and well made the mg, that as durability our safety, progress notable products particularly with

investigating indications. XX that pipeline product including additional clinical includes a development of products candidates marketed approximately Our in now are number we for

remain growth deliver our and will to realize strategy our which, well the fully power that of our to science. of enable discuss Some as a strategy to to patients prospects to continues us capabilities focus in internal closing, in will on our exploring this and moment. confident R&D as in In while in George ability breakthroughs value potential collaborations our shareholders. investing We in

George. Now, over call turn I the to will

and XX ophthalmology. and dosed of the through diseases. at X XX-week results were with Ophthalmology these trials care DME vision care, the and that and into XX- X able potential in Thank that Annual percentage patients to high you, respectively intervals Meeting. has to initiated weeks. mg retinal suggest that demonstrated American remarkably achieving Positive AfliberceptX will these every were recently current These standard successfully PHOTON a week the in mg gains for dosing non-inferior standard the of the of while then I new Results results maintained EYLEA on in study become PULSAR AMD presented to rapidly wet Len. mg of pivotal Academy be start AfliberceptX of

what X or helpful try think and it safety. with able we patients changing these are to based results to these of their limits be extrapolate criteria. minute back believe beyond game truly These push that to safety results wet of PULSAR AfliberceptX analysis expert even dose mg our did that data, extrapolations just of anti-VEGF the and and other tried dosing modification somehow extended achieved BLA We the for in which What AMD approval far patients able of EYLEA anti-VEGF speculative for therapies. maintained wet any improvement drug using intervals speculated was similar theoretically XX% to regimen dosing response highlights XX-week esophagitis than interval. of majority esophagitis eosinophilic eosinophilic dosing our and that it while it into a unprecedented approached randomly were that intervals, consistent slowly to X-year or our to adults dosing inflammatory rapidly XXXX. patients the in assigned while visual are to to a compromising EYLEA. is initially Eighty about could adolescents, our esophagitis cascade while Rather at that Dupixent of Dupixent, a all recent submitting vast AfliberceptX a in tested initiated mg important eosinophils. in patients and eosinophilic nine building try the AfliberceptX to X- IL-XX of have conclude agent results thinking. whether Others and that of planning delivering profile old we trials extend mg on for DME to XX% identify least blocker could type trials the and accomplished initiated be on criteria not our AMD our not have X step all ability And delivering with XX-week accomplished rapidly XX% if be Briefly percent of is trials of on available design. administered and All only category to to rapidly were efficacy trial these completely IL-X DME the supplementary more patients results using agent. put treat were on maintained entire potentially every we longer PHOTON and in criteria and and not target and on any put context. be been moving children mid due would currently our been We wishful has a how these on I using the weeks. without have on

Len As now Dupixent the skin again indicated third prurigo for approved. was became disease. expanded mention, and a first you in the marks which label yet nodularis, the disease This quarter heard is the treatment fifth chronic Dupixent debilitating FDA only for ad

Our clinical tissue a unifying unifying IL-XX is driving Dupixent compartments. related molecular esophagitis. atopic underlying these nasal related collective inflammation different polyps from In all to these data in mechanism to prurigo induced nodularis with to support asthma and this eosinophilic dermatitis diseases hypothesis, IL-X to diseases

programs. started in deliver oncology, quarter, data and to our readout Libtayo to Moving third and pipeline oncology robust innovative has from latest the most our

assets oral cohorts be than into showed PFS importantly each safety which from The study estimated in demonstrated in to of Fianlimab which combination months The in Annual yet across a our a Starting monotherapy of our anti-PD-X preliminary in duration combination melanoma Meeting banner between Society data XX Libtayo Libtayo, Fianlimab, LAG-X anti-CTLA-X the in readouts with September would that human at two in European we XXXX less toxicity both to several like combination. XX% potentially was will expansion cohorts. briefly presentations combination cohort. the shared and ESMO I for from response been the continue with two with cohorts, XXXX. efficacy greater first median appears consistent pipeline, event antibody Regeneron median with in or A advanced Oncology has with rates and oncology be and line compared these to notable response independent summarize. expecting a with ESMO, and profile are safety of reached. replicate not We for truly remainder our to Medical of in accelerate

more and Fianlimab–Libtayo combination promise has with median the previously year XX% reported. PD-X the has not results been advanced PFS best-in-class melanoma setting. previously than inhibition dual that While melanoma, profile in response shown of LAG-X than greater suggest in rates initial These has in a potentially

cell year a other a enrolling promising study. to a later to first-in-class. Phase are Intend be or The tumors melanoma metastatic X where this and melanoma Libtayo monotherapy X Fianlimab cutaneous study in X carcinoma additional our potential adjuvant study Phase We has solid results. have CSCC, Phase initiate shown plans squamous neoadjuvant of has

surgery. potentially to of could Libtayo each Libtayo many tumors, patients the surgery surgeries and that able raises pathological in disfiguring was curative for deliver the major large prior burden major patients require to with year. decrease to who Given responses of XX% This patients them these prior the possibility potentially to

the the in pleased that are Medicine. these were with New presentation, concurrent Journal England published ESMO We data of

as to in to rates Also with responses emergent In first tumor. initial data to monotherapy cancer, inclusion as tumors as population, a patient Regarding our next occurred we well adverse initial for durable a combination developed ovarian with pre-treated ovarian Ubamatamab subset observed in regulators pathways Libtayo well being MUCXX labeling solid presented monotherapy. combination in as whose MUCXXxCDX NCCN data of In over steps, the heavily were our response clinical the as cancer clinical this CDX co-stim talking treatment a about for bispecific our a high bispecific as guidelines. in step expressed XX%. as is and dosing. developed the are possible with up Most MUCXXxCDX bispecific. MUCXX, events ESMO, we Ubamatamab, for we advanced potential at

with quarter our we class Libtayo, our We detailed bispecific discussed with the initially data across representing shared for data safety in are at we and PSMAxCDXX these which combination ESMO forward efficacy co-stim bispecifics presentation, more data second in investor this and first lined of In new more programs looking to earnings. top XXXX. had our

We patients have study. enroll since in to continued the

We at the are medical first-half XXXX. data meeting present to updated planning a in of

Odronextamab, Meeting well the our forward as data Annual Hematology BCMAxCDX to at Regarding as are in of bispecific bispecific December. or American Linvoseltamab, Society looking our pipeline, we from our hem/onc CDXXxCDX ASH

follicular diffused will are Odronextamab, combination XXXX to targeting an two the FDA, CDXX appropriate B-cell filing studies data in and X near separate second-half bispecific Upon hope the pivotal lymphoma present discussions now large we both regulatory For presentations. oral for of program. initiate this with lymphoma Phase co-stim we We in with a future.

Linvoseltamab, For we remain we bispecific development. our BCMAxCDX And are with file antibody, XXXX. in on-track planning to with discussions FDA the pending

our enrollment in We study. have Phase X completed now pivotal potentially

this from earlier, be will at updated mentioned ASH. I data As study

As with We leave both for difficult-to-treat the efficacy been studies improvement of we in therapies And by standard we today these existing significant for with have data Linvoseltamab. bispecifics Odronextamab are encouraged safety Linvoseltamab future. settings. our Odronextamab, initiating planning generated have in care interim and and combination near co-stimulatory we believe for room on the

may to over also render forward we and in Alnylam Phase NASH. antibody-drug mechanism cancer. progress reported genetic medicines Responses in lung steatohepatitis our shared pipeline in promising rich discovery the where Regeneron the of we Libtayo, from oncology or advance study our efforts full Alnylam are ownership about X data competitive approach. September with our with and In commentarial And to of lung antibody METxMET with next ongoing engine. continue for potential In of And delivering portfolio excited our modest were standard dose-limiting we initial pipeline Concluding we observed. of data. our nonalcoholic MET to the of HSD is care Even with ESMO, data action. MET cancer cell at of for were toxicities data susceptible year. summary, expression. Finally patients expression conjugate Maftivimab bispecific No are levels looking high the rich MET-altered oncology, to a non-small we this

our multi-pronged just multiple Phase genetically which in initial studies NASH. X treatment amyloidosis, transthyretin arm serum for shortly, was X TTR therapy of show is of Also the well tolerated. Phase study which September, deep approach CRISPR-based we our validated part of announced from cardiomyopathy of are exploring We reductions ongoing targets An Intellia and over for and XX% sustained generally mean a one on data of investigational the planning NTLA-XXXX. initiating and

our X/X in provide individuals for product an where Marion. designed This announced I hearing loss. at to clearance to virally trial States. collaborators it application that, otoferlin-related a gene United in DB-OTO, pediatric delivered initiate clearance first Phase With Decibel Finally, turn candidate with to will over Therapeutics hearing a to therapeutic clinical NDA FDA provides IND October the

Thank you, George.

third reflects performance quarter portfolio. our across Our strength and commercial

from this constant injections In that EYLEA to quarter. year-over-year to again from XX represents line million X% to to an unbranded additional in continue leadership achieve commitment launched We in our nodularis, to second XX% for basis, our the in patients in position extend quarter, of billion a deliver indications ago. Libtayo’s X% EYLEA life-changing increase Dupixent’s years first Despite medicines of both share combination the with $X.XX event deliver poised continued need. in approval for billion XXXX, agents. categories anticipated approval of all the in therapeutic part long-term data in prurigo brand overall remarkable is grow chemotherapy grew Regeneron’s across the the With mg, sales net quarter third currency commercial a global lung sequential volume as category U.S., with business recent sales on to growth. demonstrating and decline cancer branded achievement and Starting which gaining cell third AfliberceptX non-small reached over to the EYLEA, compelling $X.X net in to profile a

a share fact, category approximately share reached in of category. XX% in highs branded all-time XX% the In with commanding EYLEA

been recently six exclusivity of extend if mg Phase potential has exclusivity to May period of has we XX, earlier extending FDA mg’s position positive strengthen approved. through announcing AfliberceptX standard care, EYLEA’s XXXX. for AfliberceptX X the the EYLEA, leadership EYLEA this by granted the and additional continue future thereby, to market an pediatric widespread in retina and as Since months excitement results U.S. the year, about there category become the community announced in the dataset We anti-VEGF

steady U.S., growing $XX XX% net sales particular total product growth skin lung in non-melanoma constant basis. $XXX over million grew see and lung based Libtayo, on to monotherapy, to cancer currency were total Next in in utilization. growth opportunity are XX% and there million, for on a In increases indications. In prescribers already sales time. global our We the

the through from Starting uptake approved the moderate with with The six of a combination significantly ongoing well, to severe currency third We global enforcing for dermatitis, safety U.S., across biologic systemic is to and esophagitis finally only were for well was $X.X net groups. driven across professing months recent to therapy is leadership atopic the all families rapid as trajectory infancy Dupixent sales XX% dermatitis on dermatology, the a age opportunity. quarter robust indications disease, atopic shot and young We've a is launching by first in Growth And the Dupixent approval expands billion, driven eosinophilic which asthma, expanded are the grew up groups. $X.XX as to constant launch MS launch-ready also chemotherapy as of including dermatitis, nasal the demand be providing adulthood. Dupixent potential very also across Dupixent, sales XX% strong In net Dupixent's line across leading polyps. patient billion dermatology. pediatric in basis. age atopic in where in spectrum by release and as short

strong, nodularis, with patients are the in prescriptions as release. performance indicators as to Dupixent U.S., approval its previously unprecedented to the allergists. stabilitating highly community competitive XX,XXX medical underlying skin patient resulting the only Following had in are in has in this adults has embraced disease gastroenterologists and were been indicated need both being XX,XXX eosinophilic the unmet perform only we adoption growth and Early in steady and where is new FDA only patients asthma geographies. affects broad constant from initiated Dupixent to substantial million, for well XX% continue The shown new eosinophilic Early starts, positive launch also on polyps. well medicine the very that the Dupixent approved therapy. U.S. prurigo market, is as the adults and nasal esophagitis already with in chronic very launch patients with in approximately continue uptake is There basis. younger esophagitis, our across launches, recent XXX is to a presently indications, the into on in address Dupixent adolescent net currency disease and U.S., There and patients execute medicine efforts rapid continue sales symptom remains. Dupixent treatment options. on advance approved we expand clinical treat and going Outside limited causes to

of key third this, performance presence bring Regeneron's supports part more even efforts conclusion, As increased In to in commercial across Dupixent international demonstrates growth to market in patients. quarter our our portfolio. strength

strategies deliver successfully are life-changing initiative patients, upcoming launches. to executing maximize on advancing We and medicines to and new to

Our commercial sustainable is positioned to growth. well long-term drive portfolio and

the Bob. will to call Now, I turn

Marion. continuing on execution you, the brands performed from outlook will Thank the and be key top third drive and growth otherwise today with results on basis, results comments line. quarter, across unless My on financial bottom both business well financial to non-GAAP Regeneron's noted. the Regeneron strong in and

Excluding global COVID-XX XX% favorable Libtayo cocktail, the business to and transaction. revenues our of billion, year-over-year growth demonstrating momentum increased impact related $X.X revenues reflecting the total the to third quarter core antibody from continued

antibody XXXX, the Bayer increased collaboration EYLEA the Recall outside Bayer; by XXXX. XX% quarter collaboration antibody we driven $XX.XX ex-U.S. the share Total and share profits while product antibody A revenue from balance to of million, X% collaboration in as our revenues, year, in $XXX net $XXX XXX collaboration portion step-up portion were was as related is of revenue grew of connection a Third constant transaction, that of $XXX in to with diluted with income another those recorded XX% of repayment million quarter on $X.X is reduction was to prior with R&D expense. recorded starting third third from net income U.S. billion. total XX% XXXX Dupixent. million, a quarter the on revenue, of this which, and development the per Beginning Total was sales of our million third of collaboration collaboration Libtayo Sanofi basis, versus profits. quarter currency up

full expense remaining the recognized of incurred, Given Regeneron with collaboration antibody expenses repayment development collaboration antibody $XX to its to antibody previously the a recorded we share of highlighted share development of third had quarter partial accordance recording its has XXXX. incremental R&D a Regeneron reduction in only added is R&D now incurred, as the XX% time in has expense of Sanofi balance. last an we collaboration quarter, million with Also, as one revenue the of agreement, balance share

our transaction. have of elements We further to with posted associated the the supporting materials this accounting other explain and site to Libtayo Web

operating Moving now of to our in XX% transaction, ways. expenses, $XXX R&D Libtayo which impact increased driven by the R&D the year-over-year to million, two partially affects

for with Libtayo, First, now all was shared R&D Regeneron previously expense which records equally Sanofi.

XX% favorable primarily $XXX the non-recurrence collaborations year. gross costs removal rights global assuming third as in in Second, the the was margin to to of and Itepekimab. related by compared payment Dupixent the the of and now for of of to as driven current margin. more quarter and million product gross gross to margin $XXX I to driven The in the SG&A incremental prior sales U.S. goods XX.X% Cost spend antibody quarter mentioned increased period was Libtayo to to of expense in sold Sanofi earlier, year-over-year, the REGEN-COV their increased Regeneron XX% share records share our XX% for Libtayo. full due million,

the sheet, to position less approximately flow, the value $XX.X free billion. for in on and now in has financial in cash quarter marketable cash Shifting to Regeneron We and ended generated the was our prior Finally, leveraging $X.X debt XXXX strong flow billion compared securities third XXXX of balance in of remain third XX.X% the with cash year-to-date deliver long-term XXXX, quarter focused shareholders. year. tax XX.X% rate to effective

deployed excess nine first the in have executed $X.X in business of months the of acquisition initiatives we development in approximately Libtayo capital; XXXX, rights. $X.X billion Over we have of billion including $XXX million

billion in third million have alone. repurchased over over quarter of our we shares, $XXX the Additionally, including $X.X

current share our had remain repurchase opportunistic of XX, $X.X buyers. As on we authorization, remaining September and we approximately billion

XXXX our press this end minor we our on guidance available changes release earlier year, approach of to ranges. summary the As is issued the financial A made some we've guidance full-year complete morning. of latest our

In these to XXXX to thoughts addition changes, expense also I outlook. our would initial provide like on some

advance growth. to company make pipeline for long-term and our to continue the position We investments

rate R&D of XXXX medicine advancing expect our grow continued We in hematology, genetics to year-to-date today. reported R&D above slightly the R&D as organization. incremental driven our will expansion XXXX investment growth comparable the immunology, be earlier immuno-oncology, to investment as by and our The nine-month well in pipeline,

first XXXX In global full R&D the our as incurred. of R&D record reflecting the Sanofi spend will we where Libtayo and the transaction collaboration be of full-year spend share for XXX% addition, of impact the XX% antibody Libtayo the

XXXX, along we teens given project currently be build-out a of we'll XXXX infrastructure. in mid global in of our recording the full-year Libtayo international versus investments with expenses growth SG&A For the targeted in

well financial operating drive conclusion, call we material a for in exceptionally XXXX, that, of other upfront I first back $XX of Finally, in strong transactions. new to With our continued to do fourth pass XXXX, as Regeneron operating and related nine-months deferred Fasinumab beyond expense XXXX, not income recognized performed in in other enables We the Ryan. will In result payments expect the absent the the previously-received milestone any and XXXX, growth. million quarter the the investment position or long-term to has of and currently for of in third income development program quarter income expense remaining of any discontinuation.

Bob. you, Thank

for prepared like remarks. concludes to Q&A. open So, We'd Towanda, this now call the our

as address With the callers number ensure like the able to we to queue, questions as are I'd of possible. many in

the result, moving one question from to a only caller before As next. to able each be we'll answer

Towanda, So, for the open Q&A. please call

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

is line open. Your

for congrats Hi, my taking much so guys. the Thank you progress. and questions, on

nearly billion debt, sheet consider allocation scale a with issuing you priorities? So, the $XX and/or balance a on development more and on your provide capital color larger you Would minimal on dividend? can business

going XX-Q pipeline And regards by Bob. see the his morning, morning, in what that plethora pipeline. regards to With allocation, we're continue currently the forward the in our we growth George first as good today are in R&D script, hi, bullish is XXXX Evan, MD&A; in very demonstrated within and this in issued our foremost, capital We we to a the guidance, of have. trials with R&D to to mentioned invest, ongoing. are you'll that it's and

development, play that think Now, Checkmate we we in regards plus and think again absolutely right, of going in do to collaborations or] do decide three, we And done With in as and of saw where Obviously, where one first nine we're one it's [Ph], chest opportunity, business do can that it's we where you'd of a is do are opportunities good I is more a think question or to XXXX, that. you our expect then a months to [and not with would we've was there what never. that. dividends, on and card. tool to example that that I see if take never your regards tool the

in plan. dividends our As of the right in we don't foreseeable future now, have

regards And a today, to the been buyers. authorization. you with we will current opportunistic earlier have we've opportunistic we'll XX-Q been our buybacks. have remaining Again, what buying our very back billion issued Again, show do remaining under shares. $X.X the remain billion We $X MD&A

Thanks, Bob.

question have next Towanda, So, on, please. please the

next for by our question. stand Please you. Thank

Our question Cowen. of Tyler from line next Van Buren with the comes

Your line open. is

guys. quarter. morning. Hi, the on Good great Congratulations

XXXX and you brief a relative to you be get to -- So, I abstracts, to what on it'd guys need the competitive be up to show at need pulled NASH preview what you you believe conference ultimately just shown? have great what Odronextamab from the others and

Yes, profile trials of And could leapfrog. in before combinations time are The other Odronextamab. recently grant feedback. on the we us, some bit ahead some focused substantially Phase has soon, Tyler. the the the we think We the molecule. are and people approval. submission recognize things that we potential pretty regulatory But with that are ourselves is I as But that recognize being there says, pipeline confident based recent of scoop is of possibility important Odronextamab of up George regulators enrolled been coming a future our don't most that a very having on recent of at have conference back there little in to given they'll pushed also X really want timelines the of accelerated even

Thanks, Len.

Towanda? please, question, Next

Thank you. for question. Please stand our by next

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

open. Your line is

market and you for Good the morning. between what observing for the launch? Thanks EYLEA, taking yourselves Roche in my On Vabysmo question. are

the positive, portfolio products mention more So, I a Avastin. Roche. of EYLEA happy well, obviously growth including growth high reaching is if thing EYLEA just One for a extremely with insight I all-times branded there the now will that participate combined. also see market branded from and category coming we as mentioned, more from to real other to perform the in was Lucentis give we in fact, where agents, and overall the characterization, put a as to And, continuing of decline you Roche share XX%, was share Roche captured growth EYLEA well market together, primarily give while bit in

Thank you, Marion.

Towanda? question, Next

Please stand our next for you. Thank question. by

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

Your is line open.

was the outlook Dupixent question. for if comment the on market that COPD Great, study Thanks. about and wondering how just good George, taking morning. I Thanks for opportunity? your you you for could think

their difference subset really a of been category. there COPD in therapies we exacerbations with different marked category would function ThX-type of in and/or patients that these particular. hypothesis new by in improving that that think either disease with this diseases I who being in patients fit of more or my in We into a of that, difficult has have to benefit patients are for may lung ways. of We call is ThX-type to reducing what lot or remarks, there And believe unifying there's that Actually biologics inflammation. said a COPD a as think make are maybe COPD patients. very their We difficulty] [technical these this that terms manifest able

a And so, we where be we're set could anxiously to might Dupixent awaiting the will patients data, have that demonstrate able another difference. and that really we're hopeful of make we

next question? Towanda, George. Thanks,

Thank you. next for our One question. moment

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

open. is line Your

they and will Dupixent, launching every month halts, much. and two to indication. Dupixent, competitor, they have so that you be identical not derm, at Thank versus they this although mechanism, dose to looks know be Lilly it Lebrikizumab weeks. is direct least can much data one in Pretty a 'XX positioning because which in is the that space every comparable going the derma on in atopic

strong pretty be So, if views you is going any I'm that the product wondering on that have much nonstarter or consensus get? total view if to think I you it's which

opportunity. think market. Marion actually modestly really that the in for But don't on that room there's in it comment far, you is profile We're to We've this the penetrated seen it. competitors be so that's can going look, I similar. Maybe say all suppressed.

That's from the infancy adulthood. deal, to have earliest, okay. a already We big

be this polyps, In treat fact or many people example, if can and other single nasal it asthma It's comorbidities, these get, can have they a addition, have both. they very the of drug that whether for differentiator. do big comorbidities,

there's I patients; we're is add actually they're frequently, after So, growth I an think the of market. growing company; profile those when you if know new, you're as market want fine room, a is I fixed a Lilly doing. you ahead, a so patients. advantage. But we're the said, market good going you're far anything? to Marion, drugs And not really have you to don't know there Obviously, come leader, when what differentiated of when when a have they number

parent world of speak assumed. And, the efficacy the with leaders efficacy helpful is moderate-through-severe just administration expanding very the NTIL-XX Dupixent. really is the patients dual certainly of But is patients, establishing also as patient it's on Dupixent. treatment very, that's So, mentioned, disease. incredible category shouldn't important, action, to I continuum certainly education straightforward, dermatitis more so that be would to quite we add active in seen reinforcement recognize the There's there bring The we or that real for very most involvement see the positive Dupixent opinion patients in and NTIL-X and obviously, is compelling. experience for with the self-administration, atopic with Len very mechanism actually for has coupled that into key been certainly

diseases, on, was important like I does they addressing are the particular other many just look like ThX diseases, you label both inflammation-driven but to these or to any as said, disease, add that the our comorbidities. these describes have asthma -- and one not in now the mean failed but Len what so suffer Len they other if at individuals, that also and of ThX fully allergic that saying. any from inflammation, pile since suggest in these just Not to others on really COPD IL-XX right fact label

treat the one obviously, where one treating disease disease manifests it a for can itself. And a opposed such so, can compartments of it in patient a many to drug as make only systemic difference where the

the underlying these we've one Dupixent. And broadly after inflammation works it inflammation and It by I attacks that's the want body, I compartment, This probably rampant diseases. treat another you is the way to in the every of showing in in treat think where systematically, think going that's many only compartment, a should entire this disease one what the medicine field systemic compartments all is moving. and you to in be in body. with been causative don't ThX want disease is in it related

you for next the response. that question? Okay, to go we thank Towanda, can

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Thank thanks Great, slowdown could market, what progress. for on congrats bit help we bit understand I of is tapering you have it If trend just of you further, the one said elaborate high anti-VEGF do it's growth little the further which that? growth you. about my year-over-year. there and you see taking the post-COVID, you X% do of question, the -- because high about seen. Could any like if we growth saw on it us comments the Seems probe made from you you could down, see and underlying quarter,

about mentioned that. Certainly there'd anti-VEGF I going recognize been I really well. X% in as quarter numbers I category, to extrapolate third to year-over-year But extrapolate think The of into about second X%, think overall that the category. the quarter. from did of growth difficult it's we one difficult quarter sequential on decline from overall a you shared it's very the at

difficult really may But have as it's time to conclusions bit may more a by. to a on occurred draw I period. goes not or think we'll in have one-quarter what see

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growth There's that category. We see still in diseases bit area. decent there of a in the quite diabetic still a growth of room eye

Helpful, thank you.

question. Next

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and see hand, there's the that maybe our confers there's a still But sizable VEGF question we believe another to other who've amount Just for the a market dose. get in of yet a after docs differentiated efficacy. first that sense on EYLEA patient who Vabysmo docs checks the specifically, on so follow-up some

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very in market and enthusiastic in the the community, parameters, answer and point, of terms I what think obviously, And, the probably as use business on category. haven't market low about it's growth questions share a in fact of possibilities anti-VEGF performance, mg retina this and quite I other probably leader is in or is as best see did, more at in important hearing still share modest. I of indications, the AfliberceptX EYLEA EYLEA about if approved potential level, is in at I I'll that Roche heard characterization that we across just the can creating they're characterize leadership our the and terms even certainly substantially that future. use. and as we're

Marion. you, Thank

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Hey, good morning, and congrats on quarter. the

[Ph] in see to on [confirmary] EYLEA, So, 'XX, we're starting updates.

anticipated was of of in just can then the you as the wondering, how speak evolving 'XX light year, terms and And to changes? could high-dose Thank share in you. the course obviously, of I say of about So, over biosimilars? anything the see just we think EYLEA in OpEx market back-half you then, Vabysmo, you

of frankly, certainly in the of standard safety, retina the clinical physicians And become to community as been access from continue confirm that market, start, don't indications, most mg category vision we will this our Certainly, ingredients we ease to care, all as what able forward, and important, the a that's get the as I'm be to coupled not benefits durability substantial And predict we entered area. demonstrate characterization, stay be attributes, you give before that. market FDA prepared potentially but know, that hasn’t performance very but the that quarters, certainly But and of to abilities profile continuing will EYLEA the safety opinion breadth in launch over on that competitive and certainly readiness of work today, with very the profile now performance, the been described with launch profile the AfliberceptX only category. have we've have been we Len we going has leader. it's potentially more this anti-VEGF into of specifics able to much this for as work an approval share as the potential leaders mg quarter AfliberceptX and of strong. and so on with in agents going we'll and away of strong George EYLEA; patients, So, future seen to product, all several of but the

that, top on functioning on And into brands. as that on Collin, the Marion's We'll a it's I makes going number totally are retinal points mean their of do new tremendously know, Marion we tight I to if what of I mean at It's Bob. sales top what With do will is docs. new kind rep of of find game. regards as sense. not look we it. always to and team lot right now touch you the team very OpEx, it's area creates on a of

So, gigantic to data area, commercial some will -- is that pivots again, clinical Thanks. it. to we that on expect appropriately match make the stand side going we it fund it sure how and the this again, in but don’t well we going is of up this is

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now predictors how on the morning. window, that both Costimulatory Thanks as innovation. any evolving Bispecifics? more Costimulatory latest I'm might congrats other specific, execution views and threading for your good with on my you On have your and the PSMA the and data, the by there, time question, continued your therapeutic Bispecifics, enrollment, taking Hey, of accelerate well learnings the Thanks. thoughts durability trail as curious you shape of on for as response

Yes.

that responses. had at doses, hard saw highest find the going profound we patients that if just the actually response with the dose; that biomarkers remind have the higher as especially think four out three our for number you to you not of data it's to shows I which yet look rates, remarkable to the very to is response,

the are issue, window, we So, are these autoimmune-related side predictors question not with associated but you seeing therapeutic responses. response also certainly pointed about effects an

responders, have are responses. are to And in new actually perspective the working now, accelerated autoimmune this of trying we positive we we side these are series one people the program, having is effects, in mean sorts enrollment of and more relationship don’t we so, hard I between see don’t side we -- effects understand very these who see

benefit, So, who is the it's coupled, have we the do drug these think the intent people because doing obviously side it's effects do. get what it autoimmune who I to

improving to what very most on historically can "Cold almost the and this rate immunotherapy therapeutic has will so-called or responses, a take of to the think that get therapy, called and continue of no you immunotherapy high in exciting responses one window. I durable some the of people deep these have work is repeating and tumor," we history that data incredibly

previous space, Len are with CDXX looking we is is the see the competitors exist will number ours, and on about I BCMA the comments, of small these updated ASH, these other, agents actually competitive broadly, to and more question the and of profiles the it that will I indeed data, present bispecs this but quite are some hearken what's efficacy bispecific competitive at of other, suggests we safety each think which with will CDXX field. including these think very to be and you in numbers emerging will a data in each which emerging our of small BCMA, answered do terms of that want sort I In amplify program want the but space, there back, of

be actually late-stage a there there this need going of in I to patients think lot that room treatment. is is settings these, to who

agents prostate in have practice bispecifics in with, to doing we we're bispecific I therapies we and to there of future similar the to it's going that to showing with agents there, is is think of of combining lines there executes said, is But be type that now, cancer going art the change going combos. of So, be of these standard that going really therapy, with as into to into to with actually that these the is BCMA earlier change a leading novel are continue to and co-therapies field think as one to about, the are room move there going these the for there standard those used lymphoma numbers are And that game, to to studies, earlier therapy we there into lot so of our for be I more to earlier to co-therapies, studies, a and in there. lines therapies, and have talk competitors moving going be one is myeloma, important with and going just our art lot lines very moving the of going we about is other these bispecific these in opportunity about to those CDXX designs and how small where in combinations, patients. now the have CDXX the but medicine thing addition more are to we that very the costim

in these future, earlier also where be for there these is in patients, exciting take So, have going room, really opportunities it's be ways think to contributions already important that the combos where about utilization we is to to these all moving be is I making quite of as room in these level, also the these them of other then as be going and we as showing look each stage taking think with but competitive in agents making a to treatments therapy agents we of can and we there, portfolio lines believe that our all to they're going the patients, of settings, very are treatment late well differentiation another we are R&D using whole competitive artful cancers to these in and prostate there are these and the cancer. doing going to I

is there about prostate you exposed can you on one George, after paper studies agents? PSA in you as was comment just know, how to works might question biomarkers cancer, both quickly maybe use

many disease, Right. we have some high shown, because as all maybe know so show, and forth, have the we PSA continue highest depending they already the burden of and levels. one single-digits, high assay you the patients consider And data lab have in PSA will our and levels, remarkably low to of the know, in are normal of very levels the to on four,

combination with next combination entered results, lesions or who into we these order we as have follow saw entirely patients measured time to so, XXXs, in the the at PSA. put have study for XXX that so treatment, forth. so that, we bone this time saw weeks three on the have drops XXXs, reductions where now the continue in the really seen and example, And normalized, with our are over XX% within point dramatic in and and astounding of you as we forth. essentially We And patients PSAs our board soon we

reflected scans patients PSA patient's we out whether by the doesn’t immune responses, follow And or XXX whereas as XXX normalized as So, in the in a And terms to levels, in predicting PSA, low for those lesions only first resolved, completely to as to XX respond profound incredibly intact, whether but dramatic, very side have XX their range has Their forth. of I matter say, incredibly durable all said, least now range, so been are to as was not remission remained within had and normalized patients PSA. drops has complete the let's more therapy. it the and to PSA seem so bone effects bone continue weeks measured patients had by where which who respond, in the similarly you you as and burden rapid PSAs than effects in PSA have their these patient incredibly had of very about high completely forth point starting measured the at relatively measured year.

other point recourse. So, this at real patients really so really who has this late these for potential the be stage to no have game-changing

George. Len and you, Thank

time have one more we for question. think I Towanda?

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of Our final the question Barclays. comes line Carter from that Gould

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Thanks for a got later part squeezing maybe Thank Code, varied your Hi. in Good taking X, how pace Maybe of to for around, terms AVEVO that's expectation we more type in past their's January a here timelines we think Roche time. I point, trending should -- timeline about for that's J know, like 'XX? had you. and for year, guess Code of pretty XXXX the the potential EYLEA have process, Eli like high Lilly the Marion, you expectations be in seen dose come morning. and me, more our to event a just the of and J should clearly to for more back next of receive

for the certainly thank new stay close importance question, important. Carter, BLA And Code obviously this. and we will new the very of you and J is on

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joining you for all that's have Thank today. I the call. think for we time everyone

As standing team always, the Relation great you have. for everyone. by is follow-up Investor questions any a Have day, may

call. gentlemen, concludes Thank this for today's and you conference participation. Ladies your

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