Earnings call transcript Q2 2023

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Operator

Welcome to the Regeneron Pharmaceuticals Second Quarter 2023 Earnings Conference Call. My name is Shannon and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

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

begin. may You

Ryan Crowe

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

President, Leonard Q&A. me and Executive Chief and Bob we today's and McCourt, Financial President Co-Founder, open are and Board Joining and call Board Chief President of Executive President Head remarks, Marion Chief will the Dr. Dr. Co-Founder, Schleifer, Officer. Yancopoulos, on Officer; George Executive After Officer; Vice Vice prepared for Landry, Commercial; Co-Chair, call Co-Chair, Scientific our

and and I limited and including remind coverage anticipated to may and business, financial collaborations, other but forward-looking statements on milestones, related property, that litigation may those payer Regeneron. actions, made matters, to are related and guidance, and programs, forecast pending products include remarks regulatory proceedings, include, would like finances, statements Regeneron issues, and Such its regulatory anticipated intellectual reimbursement about competition. not today's call you development diversification, revenue to

SEC quarterly including which ended filings XXXX, Regeneron's this Form statement June material in results statement. subject A found other United the complete that and Each more from the Securities filed and Exchange be uncertainties the period forward-looking projected actual is risks that with in morning. was its to can States and of XX-Q for events with cause materially could and risks those to Commission, XXth, differ description these

as of to undertake statements forward-looking information, events, a not any future update any does otherwise. or Regeneron result new obligation whether

be addition, note non-GAAP GAAP please will in measures that call. discussed today's and In

IR can to be further our those Information available reconciliation which regarding our website. Once to release corporate GAAP accessed results concludes, press and measures Bob will of measures questions. non-GAAP and financial use of and be presentation, our our call team our available the is financial a on in Landry answer

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

Leonard Schleifer

thanks Ryan, its while today's across call. toward streams. to revenue in our make earning the results of organization the delivered everyone quarter Regeneron strong and second and Thanks, while continuing growing business of long-term joining diversifying simultaneously to XXXX, progress the objective

in collaboration the revenue proportion continues revenue to of the of excluding Total those for were revenues XX% any quarter increased be to with deliver by last trajectory revenues Libtayo total primarily pleased we XX% the by product Overall, which long-term with believe XX% and the net contributions antibody business XX to the the year Sanofi were driven revenues, years highest Non-EYLEA prior respectively. XX% growth. company compared quarter, grew sales, well-positioned by contributions. COVID and and

In and on a financial execution, the few pipeline second during Bob will provide commentary results that minutes George, achieved Marion, commercial quarter. we and developments,

focus of I the milligrams. For on will aflibercept remarks remainder my today, X

will pivotal which PHOTON more including about in with clinical data the edema study macular compelling very the excited are profile two-year discuss We patients from George emerging diabetic detail. the in

Now this getting approved toward candidate has by progress I the product the been will summarize important that FDA. made

for manufacturing or Letter announced did macular drug wet diabetic Application trial issues substance License or we the in with design, aflibercept not degeneration, nor safety labelling retinopathy FDA patients related milligrams DME, aflibercept age-related treatment Biologics and June, requested any to the clinical has efficacy, Complete clinical for additional any X we data. profile, the late identify from the FDA our Response As milligrams regarding CRL received of that X

XXX milligrams. to the observations observations, inspection organization, a aflibercept in that and has milligrams, disease, of a our third-party vials X well is that with unresolved related on The of date CX Regeneron to as May based engaged X fill facility a a PDUFA XXth. entirely line aflibercept CHAPLE was Catalent's contract Catalent, the XXXX were manufacturing as Form vial-filling pre-approval which ultra-rare used August CRL in resulting The antibody inspection noted manufacturing to from FDA pozelimab for for complete

both is approving aflibercept was conducted X cited control required the FDA BLAs inspection FDA is BLA. the clear work review process as We, facility of the procedures, discussions The and line. FDA the part to on had Catalent, and allow BLA manufacturing maintenance. involve pozelimab multiple Broadly There and assume aflibercept that a speaking, process of validation, this and X milligrams equipment for observation understanding milligrams the have the the that to since CRL. remediation the production

August the already they provided by for XXth and to the these information review to their FDA said data requirements has required provide the could expeditiously strive complete pozelimab. of some data date able will and expects to information that mid-August. FDA prior PDUFA to satisfy remaining be The to and Catalent

months. unable the their to they before are FDA prioritize this complete that extend they by three their it if said to date, as do they up will continue to review, complete early the need and stated may If has they to that However, review review as possible. the extend review FDA

data BLA been that the BLA of resubmission, milligrams the stated actions support pozelimab the Importantly, context has pozelimab the and of FDA submitted. will the X aflibercept review the manufacturing has in their BLA which both for also Catalent already

strive observations expeditiously, and all summary, XXth. In required by August their Catalent mid-August stated address and pre-approval data has the to submit the complete Catalent inspection. information to they The manufacturing FDA from prior we the of review to resulting expect will to that

we shareholders. to X collaborations our on of focusing confident the BLAs exploring FDA aflibercept act quarter. well and while breakthroughs remain third In not, our and the anticipate to as before on we strategy ability closing, milligram the to our pozelimab patients capabilities of potential in R&D as will end external in internal deliver If investments value

George. to over call the turn me let that, With

George Yancopoulos

update were to. At Society majority start aflibercept referred Len American DME to I Annual and through we X presented Retina improvements anatomic demonstrated Thank data vision meeting, of milligram from Specialists weeks. like intervals results the the sustain would two-year on and continued the dosing recent study. in Len. X that of PHOTON you, patients that with randomized the XX-week milligram our to XX our These to vast XX-week aflibercept data

point, able XX% criteria XX-week were at dosing eligible for of intervals. XX-week than every all aflibercept dosing XX-week criteria X patients beyond XX% maintain milligram at the able extend or least it. two-year for XX-week entire assigned baseline, of to with for meeting intervals, every patients including On while were that for who the XX% XX% maintain greater patients interval to intervals were to dosing the many that intervals, to longer met extension dosing period,

EYLEA. Sustaining and safety of dosing X maintaining field. anatomic intervals remained consistent milligram The the such while aflibercept two years over in vision extended with improvements is profile unprecedented

investigational X the planning the retinal position Our and profile the third Bayer AMD. quarter, results to in this medicine of aflibercept of standard clinical milligram future analysis to second of share care initial wet with are study in we and patients PULSAR from strengthen results further become diseases. Later the the year

BOREAS Dupixent urticaria patients and with results on and decision We by an for of announce our inflammation X the FDA of in to look spontaneous are granted eosiniphilic sBLA pleased in the COPD to We terms with positive immunology chronic in COPD. uncontrolled October our Dupixent. forward to was XXnd, phenotype Phase XXXX, the on pipeline study. breakthrough that for based Dupixent Sanofi designation Moving

data replicate from FDA, ongoing need the remain on requirements we addition to Based in a with data with such will the results, we the discussion provide study that support NOTUS the to Phase discussions expect to BOREAS and under study BLA FDA. X

to expect final continue for the by NOTUS We mid-XXXX. results study

evaluated regulatory types contribute our Moving AERIFY-X in and transform XXXX. Dupixent that smokers. studies Sanofi different levering on and submissions the reducing Phase Itepekimab, inflammation in for COPD. studies These of passed interim that which for their of treatment former futility May, track to announced is In mechanism and the for action could Both remain in by to Itepekimab the COPD anti-IL-XX X paradigm distinct had COPD analysis. antibody, an being X readout

rates with antibody and Libtayo, showed oral June, conference, consistent at ASCO data from independent new combination cohorts melanoma prior including setting. who three XX% oncology for had cohort in the XX% presentation the of In across a of to received plus advanced Moving to melanoma patients, patients we response of which anti-PD-X adjuvant presented ranging LAG-X our Libtayo. therapy combinations an the fianlimab, in

about Post Hoc factors the response settings were rate and rates of double in historically with including These expression levels. of various and prognosis varying in patients monotherapy observed represent tumor interest, meaningful populations with PD-LX clinically similar poor analysis anti-PD-X responses seen

agents, X safety monotherapy except generally managed profile adrenal majority Libtayo combination replacement. in these and in insufficiency, or profile anti-PD-X appears the or the other were with PD-LX of cases with Grade and rates steroid safety consistent higher to lower Libtayo with all which of the of The fianlimab for be of cases, successfully cohorts

Our advanced in Phase are melanoma non-small lung studies fianlimab patients portions adjuvant studies Phase and plus as cell in are X/X the Libtayo enrolling the cancer. metastatic of Phase X X

for anti-tumor with solid advanced ovarian tumors, share Next to clinical being data are planning Libtayo this the cancer. Libtayo we believe we cancer in advanced Last investigated encouraging to showed MUCXXxCDXX and and combination bispecific activity. our lead Libtayo ovarian with it to which are data other in of combining Later on monotherapy enhanced bispecifics ubamatamab for plus year that initial we may year, in combination ubamatamab, modalities.

Moving to costimulatory bispecifics.

bispecifics trials of settings, Libtayo in Libtayo, corresponding We demonstrated variety CDX CDXX our of are with has different in activity. Phase combination a REGNXXXX, X cancer which in bispecific PSMAxCDXX anti-tumor early in antibodies study currently promising with in clinical costimulatory prostate well our bispecifics exploring costimulatory in advanced with combination multiple tumor

by to or second profile death. observed challenge, adverse pose event combination the a this safety of highlighted The recently Grade X continues

be combination of to patients full profound the adverse decided serious PSMAxCDXX combination have explore to of with highly discontinue doses with patients immune-mediated to enrollment and responses, dose Libtayo who events Although lower Libtayo. continued we correlated experience new

activity we also patients will explore PSMAxCDXX as PSMAxCDXX seen We immunotherapy in combination monotherapy, and to will have we a some other modalities. anti-tumor where with in continue explore

data challenge potential our focusing of both the the the exciting the support tumor. believe We of bispecifics response costimulatory to prostate solely cancer

mechanistic of depend on with preclinical the events costim may and when costims PDX types. tumor and studies degree insights Our blockade suggest combining immune-related seen the target particular adverse

cancer colorectal immune-mediated severe CDX these our including our MUCXXxCDXX of in MUCXXxCDXX in other observed costim these with adverse combining not with limited costimulatory in toxicities as studies, programs and we ubamatamab events. bispecifics costims EGFRxCDXX have with types immune-mediated continue, costim to-date. Libtayo with our bispecific lines, In Moreover, costim these well ovarian Libtayo and Along cancers. dose-escalation other as result both may early

We bispecifics which in progress. our hem/onc excited with bispecifics are also CDX our about to our costimulatory programs, combining continue

relapsed/refractory in bispecific odronextamab setting. dosing our large which We of impressive improve diffuse that the in with bispecifics by initiated odronextamab, CDXXxCDX on costimulatory can demonstrated efficacy have hope B-cell CDXXxCDXX lymphoma, our we alone

refractory of terms regulatory odronextamab both or diffuse remain monotherapy, lymphoma In for B-cell EU US follicular large and lymphoma on submissions track. and relapsed

Regarding myeloma, heavily pre-treated the patients six with potentially early months, with durable good response with linvoseltamab, recently presented recommended data response ASCO XX% very mature. dose updated and at our at they BCMAxCDX XX% bispecific, responses follow-up deep achieving partial Annual a the and demonstrating patients Meeting better data the in rate as we XXX-milligram multiple only of median improving with objective a or of

up data safety, these best-in-class quarter additional linvoseltamab. favorable potential are we dosing with this to In year, longer believe data hospital differentiated applications with to fourth We schedule. planning the follow and submit present regulatory for efficacy, support and requirements, linvoseltamab's

with We also costim next myeloma-specific combination studies start year. to plan

genes genetic first quarter, brain, siRNA can a which approach and suggesting we to entirely fighting against back may human data up to the Alnylam other be the pathological announced in central system an diseases. In used silence neurodegenerative that and second Next the nervous new to medicines. open jointly

year. for next programs We to clinical additional plan initiate CNS diseases

first to clinical our cardiomyopathy. announced our CRISPR-based gene initiate with to terms B. targeted pipeline, with And hope in plan delivery the collaboration in Intellia, Hemophilia XXXX first feedback transthyretin we program program for Phase of by initiate to by year-end, amyloidosis X clinical regulatory in-vivo As we subject our patients in

half to late Regeneron's year. opportunities differentiated grow of forward deliver conclusion, this are we continues early-stage to and several second and clinical engine looking important milestones the R&D In and in

With that, will call to over turn the Marion. I

Marion McCourt

on and In portfolio, the categories is Regeneron impressive and longer-term you, Thank delivered innovations currently our multiple short medicines George. commercial disease across promising quarter, Regeneron second notably lead future with results our the horizon. scientific

drive As continue of Len to opportunities retinal supports await X eagerly the aflibercept our robust we will anticipate beyond milligram diseases, for mentioned, anticipated that we growth. late-stage that additional approval pipeline commercial

US at diseases. two and year-over-year share. Starting last billion, XX% the leader in X% with quarter-over-quarter. stable retinal total X% at category share approximately net quarters EYLEA remained XX% over EYLEA anti-VEGF and down category sales EYLEA, branded the were $X.X for up

minimal compared wholesaler At the end the end was the there to first the change of in levels of the second quarter. sequential quarter, at inventory levels

well-positioned Our an is maintain and strategic we're grow on increasingly competitive to to category. in and deliver focus anti-VEGF the leadership score Regeneron's

ASRS, XX weeks important diabetic second upon X further aflibercept week excited of is their the our the with Last intervals ready approval. team at least milligrams, assigned aflibercept year. two-year confirmed innovation XX% presented remains commercial in we of and high at to this and enthusiasm macular end durability our X Market which launch edema for milligram of data unprecedented of at patients

in and with new sales both on in base lung cancer, a an by million, net were is currency lung now growth steady cancer. Libtayo. Moving non-melanoma settings. sales XX% driven skin In prescribers and with Global combination cancer patients US, $XXX and of the in In in were $XXX accelerating, community strong year-over-year academic net use XX% up Libtayo the expanding constant share chemotherapy basis. up growth to million, monotherapy in

XX% Libtayo, were Outside at lung non-melanoma demand US initial $XX Growth cancer. in basis. was increase by sales cancer on a constant-currency and million, driven launches a skin the in indications net the

performance access as build and and in indications. accelerated drive key cancer for secure lung to international expect Regeneron's reimbursement We presence we markets

XX% first across US, diseases. year-over-year with to were indications grew constant the lastly Global all XXXX. lives XX% currency the And year-over-year to age by up $X.X up of and growth continues compared driven In type the sales a approximately Dupixent, billion, quarter which and $X.X of to on sales billion net groups. revolutionize X basis XX% patients net to

for prescribed opportunity awareness actively out our recent all and medicine initiated Once initiatives disease future been esophagitis, with empower approved well four are to diagnosis we number for since US of in again, new-to-brand have launches five total significant growth. debilitating across indications. indications this in seek and biologic the for the patients XX,XXX in see disease. Dupixent patients category leader treatment eosinophilic is one impressive prescriptions launch and over to is We In investing across patients uptake

underdiagnosed prurigo off launch is condition. as a go-to dermatologic physicians rapidly the Our recognizing this nodularis with start to Dupixent fast for often treatment

benefit October our estimate we we spontaneous date US look Additionally, up patients. PDUFA where XXX,XXX to in to chronic forward XXnd urticaria, Dupixent could

impressive among We largest future across indicated the There transformed world, Dupixent. around of growth hundreds also to generate whose dermatitis, thousands have atopic opportunity patients polyps, the already significant and a growth asthma, by nasal all groups continue Dupixent's indications. three is lives been for beyond demand with robust of age

growth. the delivered in positioned we summary, commercial Regeneron's In second quarter performance sustained for a with medicines strong

our of We the patients. from even current continue goal to opportunities execution with to demonstrate across are portfolio more scientific we industry-leading to and innovations robust extending prepared pipeline, maximize Regeneron's our

Bob. call the to Now turn over I will

Robert Landry

comments Regeneron's My quarter will financial a the growth non-GAAP on second strong basis and noted. on demonstrate be across unless Marion. outlook today and results continued otherwise you, Thank results organization. performance Regeneron's financial

strong Second driven revenues $X.X XXXX growth from quarter within continued collaboration with sales Libtayo. increased to total Sanofi billion, Dupixent improving year-over-year XX% profitability and coupled our by momentum

net billion. on net was Second $X.X quarter $XX.XX income income diluted per share of

with Bayer. to Moving starting and revenue collaboration

constant revenue of a our sales second EYLEA Second on was US. currency product net Bayer outside X% related up profits which of were quarter $XXX million, ex-US share XXXX net quarter $XXX EYLEA XXXX. the million Total collaboration million, versus basis to $XXX

and million year. in versus collaboration prior revenue XX% second Sanofi $XXX quarter grew the Total the was

of quarter XXXX, Kevzara of margin volumes improving was higher XX% of an Our from from an commercialization Dupixent. and profits second million, and $XXX profile reflecting the increase share Dupixent for of the

driven coupled drug We Dupixent growth resulting margin significant improvements from gross with expect from yield expansion the enhancements. margins higher manufacturing dupilumab further collaboration by continued process global to sales substance due

revenue development repaying our our balance we These which repaid factors collaboration this to portion related in by few Sanofi. manufacturing Recall Sanofi the in supplies, a reimbursed expect fully share of collaboration increase Once commercial a are contributing is the to antibody next we up also that we rate profits. are which in gradual meaningful of a are step was in for Sanofi to of balance years, Sanofi. the the

of the to to manufacturing these XXXX, reimbursements the continue half expected face second fourth for the we process be Dupixent, in As the XX% yield of expect lower be than higher half we approximately the lowest with to first year. quarter

quarter, the up the million were prior Other $XX year. versus in second XX% revenues

We continue profits half. reimbursements our manufacturing discovered to and companies, the of revenue as compared includes commercialized ex-US ARCALYST. other by Alaris Regeneron that for and of other well global as share revenue including as half first products to expect higher to for royalties for certain primarily ARCALYST, of ZALTRAP, in the XXXX other Recall second the be Praluent,

now Moving to our expenses. operating

expense R&D was late-stage mg of Year-over-year was aflibercept pipeline by including driven XX company's growth ongoing in studies. investment and which related higher X funding continued primarily or our XXXX the encompasses quarter studies headcount costs Second robust $XXX and R&D registrational representing pipeline. million, our potentially approximately

studies in fianlimab driven lines and in The associated X advancing Sanofi amendments the to therapy part was company's the XXXX in earlier-stage with hem/onc manufacturing candidates candidates. activity R&D development Phase by our earlier product of and also of collaboration impact our the agreements program. increase expense for the increased product

year, patient of million of contributions the independent not-for-profit headcount to $XXX last acquisition higher higher costs, following global the rights related an to operations in build-out our organization. was and reflecting second assistance ex-US quarter, ongoing SG&A Libtayo the and

higher with Dupixent XXXX by was versus volumes. costs prior XX% the million $XXX quarter up COCM associated manufacturing Second driven year

first XXXX reflects improved our we to this COCM be half we the manufacturing unchanged the as half expect for COCM guidance decline year the with in to lowest second of of Dupixent, As fourth the expected quarter progress the process versus year. the of phasing the

first to billion marketable $XX.X generated flow of Regeneron approximately debt less ended the approximately in $X.X the and securities Now cash free of sheet. In second the with XXXX, balance We quarter flow. billion. and cash half cash

cash We repurchases throughout back opportunistically quarter, continue shares. our share towards of deploy to the second million buying $XXX

billion levels, remain for approximately XXth, current of repurchases buyers authorization. and June of existing under shares, available $X.X as our At our we remained

year. the minor Finally, outlook ranges changes XXXX and our some on based of remainder we've the full first our for half our guidance made results year latest to

ranges We our have in provided complete tightened issued rate. of available guidance earlier year ranges updated release guidance guidance and tax latest A is effective summary morning. for and for spend SG&A R&D XXXX our our full this press

conclusion, the Regeneron for In of mg delivered in aflibercept we financial and in positive potential the of XXXX third results quarter upcoming quarter. launch excited remain second X the

With call the now Ryan. that pass I will to back

Ryan Crowe

possible, you, our we will the will Q&A. This the each caller moving from go question, question as first call the we next. before address To concludes remarks, can one be to answer to Shannon, now able please? to Thank prepared questions Bob. are only we as we many open able for to ensure

Operator

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

open. now is line Your

Evan Seigerman

guys. updates you much so on Thank the Hi, questions for all taking my today. and

going in refiling? of is going say a decision that Thank milligrams to that So third idea mean? any an you does action approval be have Class just do the or resubmission? going And is to What take to Are they provide you a on or it's Class acceptance action. you. that X the X take quarter X could or FDA CRL, if

Leonard Schleifer

Hi, Len. Evan. your Thanks It's question. for

the has said what our for the will because timeline milligrams. to just governing Class or classified pozelimab happens X be clarify, So not the as X that they resubmission X have with Class FDA

action, disease will both pozelimab, whatever that the find will results. promptly for what decision. the products. or you the the will to in it disease acceptable remind the then and for And take we govern pre-approval an we ultra-rare has and mean, remediation me pozelimab review XXth. timeline of they a efforts has we Does they BLA to the the CHAPLE happens date milligrams. that pozelimab happened, was of let they your it -- the there for FDA to position make say decision a our manufacturing them a and we X answer is If PDUFA therefore, expect The we be a is What not So when inspection expect context said make think the for on them in approval approval question? remediation

Ryan Crowe

line. the off is He

Shannon. the will We next move to question

Operator

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

Your line now is open.

Tyler Van Buren

for there. morning. Hi, Good taking Thanks the question.

FDA this the lines. end the encouraging So action the high-dose very surprised and and are the quarter to is investors by potentially EYLEA clearly short by timeline taking of

data And in on to all for the executing. you couple you August to required how can But XXth? the about days in think information kudos pozelimab few it that detail what a as are data So regarding manufacturing prior review provide additional weeks, decision from the we other a this of feasible submission date to Catalent? and is

Leonard Schleifer

question. Great Right.

So we've they in why view middle a FDA, data told by at view. August, basis submission on the know and us that. and meetings, as expeditiously will been soon that of have coming multiple last confidence so that this date, work, left to what's us submitted if information as the this review of they point can't will the have few we completed they been that told have very that forth, have point a the FDA they be strive as getting PDUFA Catalent quarter. review And in little from done days the why our has they've and The before pozelimab that submissions That's is to for prioritize that do very of they and about and possible. There the data and done FDA. that's get close required rolling written, we will contact already with has a of from information oral, an clear what's and Catalent and the understanding

a summarize rolling the So has been in to on coming data basis.

us strive clock it FDA they our be we'll the future will near will have be there a by information that prioritize August three expeditiously why to XXth time thereafter. for if not, We in PDUFA we believe the But review. everything and get of the PDUFA need, date of will in not rolling they to that's the done, told date. for submitted time months, extension piece that the up have for pozelimab will month, the we review in middle the but in that if And last

Ryan Crowe

Thanks, Len. Okay.

Next question, please Shannon.

Operator

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

Your now is line open.

Mohit Bansal

you filing very very my the And for for Thank situation providing to the you now. clarity Maybe Great. much taking bit trying right understand on question. more. thank this all really much taking little -- so just a

pozelimab it you is say part to for fair the that have related is already high-dose So EYLEA everything fair? submitted only? and remaining to Is

Leonard Schleifer

pozelimab Actually, and to we've we about pozelimab should the milligram submitted remediation pre-approval inspection, of except applies everything to for think for both you the the it, X need which final the EYLEA. way

the pre-approval same EYLEA remediation. Once The this milligrams. linked it's and to inspection in clearly will FDA and single X for context for everything then information what stated the govern pozelimab completed for to data pozelimab both. of They So required necessary of have BLA X-milligram in a together. will the the that is that are remediation review has us we happens the

George Yancopoulos

manufacturing aflibercept at and Len general nothing line. this I said think as the about operations particularly one there to manufacturing Catalent the either specific has to This with processes pozelimab manufacturing data. And is do facility, or with

Leonard Schleifer

very a point, that's Hey, good George.

the two that wasn't product it the processes the It the So specifically, pre-approval the products. on both fills to validation was that's why applies line single products. and inspection

end that it of the the in will on us comes three get months. set an as piece satisfies prioritize great. remediation done will told they that review. strive They've clock clock, rolling basis, all us and our to But that is that the last aware they've three middle to the notwithstanding they a both, submitted data that PDUFA So this. is of August, back of will the before an do information one they that's expeditiously. writing in the months, continue in, the PDUFA, being consider FDA If that amendment they they'll If original don't, told

properly is hard, we're So and is done pleased working finished the everybody very very working hard. hard, and very we're FDA Catalent and this wants very properly working remediated.

Ryan Crowe

Okay.

Next question Shannon. please,

Operator

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

line open. Your is now

Tim Anderson

Thank very a question I much. Vabysmo. the on you have

this is say or seems XX% So that driving frankly. seeing it's not better QX afterward, of play product. said docs US capturing what extended out they then patients drawing said Thank comments dosing Roche how up as with at a wondering And kind much as you're those like in the of they their I'm high the line seeing they're you. which treatment-naive figure quite that it the with market. that's

Marion McCourt

Sure.

our EYLEA as will as strong, shared I category. anti-VEGF was EYLEA So, the quarter Tom, comment And on the performance in performance. the certainly I see just the in you with we standard-of-care steadily

I much we smaller forward in market. opportunity would clinical today. from and data in where the recently the potentially other branded look faricimab the based only continue are and best Avastin. market prescribers durability performance to big very commercializing having to do presented the the We X game-changing switch the marketplace obviously patients But strength I many aflibercept beyond to are to at get individuals that seeing comment, continued on are they've capture in of milligrams bringing has of the more not in naïve-patients, seen but and profile another excited competitors EYLEA and efficacy, what know your so who safety into KOLs ASRS. say from you also source probably of want certainly, that is business clarification Obviously, But

Ryan Crowe

Marion. Thanks,

question, Next please.

Operator

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

Your is open. line now

Chris Raymond

Thanks.

another market-related maybe question. Just

free But face So some I know geographic specifically chatter these to extended for dose therapies with have specifically benefits to been around docs, decent looking and there's of level room in on injection the patients the capacity Apellis drug. of them. atrophy and of themselves make market up

expect And with we're how question, a to noticed atrophy. maybe issue. curious notion about widespread your early an docs who now the the talked maybe that effort? I safety market sizable, the Just effort that? issue shift about among Clearly, own you in then hear could have that discernible related Syfovre of a guys was about before talking is we And have you geographic think when more

Marion McCourt

of So share terms in let me first dynamic. the market

and most X prescribers all on milligram I product, that FDA a thing flow. patient and patient capacity the of it when opportunity launch the the candidate a for patient to and to for if we that patient potentially decide exciting the most we prescriber think an does is and on have gives a EYLEA aflibercept is another a is when category patient about have naïve-patient, currently or X office patient candidate and thing milligram, is important to aflibercept approval, a patients anti-VEGF their benefit the whether

comment think on I we're to premature category that in. the directly involved not it's

We launch time, very educating we and we on all stakeholders focused are for proper making X aflibercept certainly have milligram are an that at the approval. sure once though on ready

George Yancopoulos

I'm many allow very And we innovative these as approach with active are that in And feel of field. complement what an the blockade retinal in treatment our terms may that own aware we diseases. have approaches very efforts, sure in may are we've potential believe been we

about the so you'll do of inclusive hearing While adverse the like those issues very be avoiding forth, some short-term. much concerning and with in more having to efforts events vasculitis and

Ryan Crowe

question. George. Shannon, next and the Okay. Thanks, to please Marion move

Operator

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

Your line now open. is

Carter Gould

XXXX that thanks dosing and the for in speak on the you in there lower your And combination your and with terms kind Thank maybe Maybe about of with bit, Great, Libtayo, you other level implications combination fill of to change death dosing confidence with and just and morning. the require thread those can the report can update CDXX it's levels? efforts Libtayo broader in paradigm terms efforts good in transparency. switching for George a with the the of needle the with implications the you. of of Libtayo. costim of dosing all portion gears just going

George Yancopoulos

new or paradigm Great efficacy classes you actually know, that have to the question. ability untreatable approaches Obviously, cancer, to with cancers up previously really address the the and have treatment. is coming as change been to of really refractory biggest that to bring in ability agents hurdle new

signs field we've to which does in that But often in target. the clinic more of modeling the paradigm. to we're of the predictions the the to the really and costim platform what the this is have class you as terms is it the safety with that particular safety, costim have think because showing ability cancer immune just So related said, more delivered terms adverse I and what in has with comes that excitement events seemingly of associated change continues new to we beginning the see preclinical with of amount now that concerns balance said in now to the that, and seen you preclinically efficacy, seen all really efficacy

you costim see what the for apply So one doesn't costim. necessarily to other

in of doses we PSMA you out it very in has while death has the these very of as patients the dose only events. Libtayo but are the remember some can our responses, it potential associated are, associated serious like resulting seems it also who deep costim having combination, to some even cases moving efficacious, said lower in be the So adverse for cases, immune these because in associated full be only,

hoping We're combinations adverse efficacy, immune-related and these with we're from that doing moving important types not you there dose seeing not and PSMA costim preclinical are we're yet, not our because from level serious of other in maintain can very, thing avoiding combine very full So immune-related Libtayo of sort these you of the to going And we these just bispecific. we're modeling, seeing with adverse CDX the seeing very remind that combination immune-related the preclinically events. combination some we're that when events costims. away but events the in adverse with other with our

move we may well, hope to we efficacy, where better have programs trying those safety profile. as we so forward a aggressively very And are

very it's very now, So remind exciting been to a or molecules active classes time three three portfolio. active -- both very you, have individually validated we that in have classes have these of independent remember molecules, our

checkpoint particular, checkpoint inhibitors, the in have We our which validated. inhibitors, LAG-X PDX our are and

mixing events benefits which adverse validated we in now from exciting our mix-and-match the potential we is to them. the signal-to-noise, are bispecifics to efficacy perspective, maximize CDX and have The to challenge relative them time We see the therapeutic the the and to validated are costims have our patients. be appropriately matching which very

Ryan Crowe

George. Thanks,

question, please. Next

Operator

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

open. now is line Your

Salveen Richter

permanent runway my April and in from switching moved loss this taking for now exclusivity Thanks it of morning. morning. shortens a EYLEA has of Good updates to potentially question the and nice for J-code possibility of Clearly the patients ahead May.

So we from kind do secondly, population What about high-dose But permanent EYLEA? without of a the how of uptake Thank switch a EYLEA question are you, on the hand J-code? kind and maintain think here. two-part should the dynamics you. this around how one of grow and

Marion McCourt

Salveen. Hi

the start So the a started. submissions and CMS conscious at the I'll we're get to occur of dates for that requirement quarter. Certainly, of

sophisticated I we approval are permanent if approval share estimate of anticipate potentially third So have frame that quarter. the coming before use marketplace validate J-code. for referencing, at they J-code. permanent the we X make certain we aflibercept the you're and are Retina an under in would in would and temporary after having we how have on is the products that What reimbursement level. the office specialists into with the They that milligram their launch J-code to time capabilities reimbursement regular products experienced basis a newer fairly prior a to

a certainly, positive. want we across that to will have types opportunity But the with J-code do that obviously, CMS. patient the So see permanent uptake we to situation for prior be

Ryan Crowe

Marion. Shannon, Okay. Thanks, next question. please to the move

Operator

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

now Your open. line is

Terence Flynn

question. company historically. pricing for before, we've taking on the the been this somewhat Len, much so Thanks I decisions has talked non-traditional know about but Great.

You guys a priced EYLEA discount Lucentis. at to

worked on pricing. You with Dupixent ICER

here EYLEA. shouldn't with high-dose it just expect Thank So similar why you. we approach wondering

Leonard Schleifer

Terrence. Thanks,

thoughtful I and your comments we mean, similar, appropriate, would referencing If agree.

Ryan Crowe

Okay.

please Shannon. question Next

Operator

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

is open. line Your now

Brian Abrahams

with to proving Congrats just FDA need you for before Good another the any confidence sustainable and would of all my all of re-inspection the would a appreciate taking period had the time you agency BLAs? morning. where remediations there Maybe to be level Can progress that the to this? that details. required? ensure is not X feedback defined Thanks question. around your a Have And or the characterize interactions aflibercept. wait Thanks. milligram on re-inspection are on not or clarification

Leonard Schleifer

it, been your Thanks if the remediations We've again, Regeneron. usual just And in Look, X,XXX% is as basis. transparent with be required summarize submitting has this see a we've question. me as on Great. rolling contact tried FDA know close to the really, we've them know. what are been for we I let can what and We Catalent.

done FDA saying re-inspection detailed the for the the days would those quarter. whatsoever date close no that and The to free pozelimab as FDA by would requirement that But led submit need, get be facts review three-month us that. be great. they a Those been be the can, the contact. very they a believe to expect PDUFA extension, very very be has course they've seen the BLA. will there expeditiously clock to of make it this, what it necessary. not If and of decisions, We clock our In The they of indication our there August a done been fact several that try They during is of they in and discussion, review as indication to and before three-month possible. even would that extension. with any we strive middle are clear said that in can't, last no soon has that have no prioritize will would third been all but is categorical

given at best estimate So this our we've point. you

Ryan Crowe

Thanks, Len.

please. move question, Let's next to the

Operator

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

is now open. line Your

Chris Schott

terms so trying taking the and adjust bispecific approach just just come that here issues the the lowering work Can piece the the elaborate of a to equation? update? much. of to of in more further PD-X the little dosing so to to of Thanks Great. exposure much. you versus CDXX back Thanks PSMA the Maybe bit safety address approach

George Yancopoulos

say are adjusting Well, doses. we that we both should

been exploring active very Libtayo. But of have doses doing on highest doses from doses them low the dose in We the we've a variety of side. been full all already context the the of to costim

now are we're PSMA now costim. particularly we And exploring -- doing mentioned, the there doses as that monotherapy, of decrease are adverse as is events. the some So monotherapy try what to active immune-related we're ones these is to are with active, activity I

in me patients, they biggest responses you, adverse events the greater general. them seeing sort Let to cases with that some do the some remind on in class inhibitors same one checkpoint of with extent. just We're are a you see in of immune-related the

the adjust us now with the dealing couple program incorporating the as allow are window but of saying So therapeutic you we're as costim, hoping lower of But to Libtayo there. we that lowering the the checkpoint inhibition may doses into different we're doses are well. a

Leonard Schleifer

therapeutic two earlier, I of the or who patients are calls part efficacy, very effects as that's good noise repeating, get that said said he think is maybe with bears it a and side position having George that with what for to explore one. very how it starting we're signal just right. impressive in the to good the position that benefiting the George index efficacy, the to begin And most to

Ryan Crowe

Okay.

Let's the move to Shannon. you. Thank question, next

Operator

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

open. is line now Your

Dane Leone

taking I'd that on for expand a final for like to an the indication. FDA before to to accelerated Congratulations with little point may and bit and want what potentially and you review be comfortable you to could resolution aflibercept. I a for luck the discussions able the of have The NOTUS results in BOREAS your actually clarity best more FDA with that updates Thank on Thank you pozelimab reviews of study a potential package that Dupixent the specifically for of from you you. with on with early or questions. readout X get include the the Hi. mg the COPD. on ask filing bit filing the

George Yancopoulos

discussions we data Yeah. as be. right know right we now that need what is in are data on What said, from now, NOTUS. going And we're still that to could we

And so to you. give right now, details we any don't have

Ryan Crowe

update Hopefully an Okay. next Thanks, George. please. question, and

Operator

comes from Colin Our question with the of UBS. Bristow next line

is now open. line Your

Colin Bristow

on congrats the and good Hey, the morning, and quarter progress.

say specifically, maybe BOREAS? Just Thanks. interim. the sort relative share to utility on Can And you of the threshold? one you on could itepekimab Fed if the anything how not,

Leonard Schleifer

forward by the Safety Committee end of further pleased the to handled was We're This specific. approach. passed Data a anything it. we will the have we Monitoring And of we sort standard study. that at think data don't look I

Ryan Crowe

go-decision Sanofi to both blinded the Data We got And Independent Committee. from the only Monitoring are we and that.

will we So studies. final readout proceed for of those to a both

next to the question, go Let's please.

Operator

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

is line open. Your now

Luke Junk

Thanks. Hey, this quarter? this the taking Thanks there what any on provide for you color it Libtayo stocking Was more Luke or largely growth was for a demand-based? on bit Brian. the just is drove little question. Can

Marion McCourt

I'm to and carcinoma. cell steady continued indications growth. and And share our cutaneous carcinoma you, demand Thank basal Luke. skin cell Certainly, squamous pleased see performance across both it is we

to that increase that the the in that, both But for our are an we and it academic only improving is based, increasing community of but lung addition is in it not the is number is prescribers and stocking of indications, not also exciting settings. seeing In depth based. demand cancer prescribing

Ryan Crowe

And I more questions, for two think Shannon time we have please.

Operator

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

Your line is now open.

David Risinger

Yes, very thanks much.

for George, is question please. So costims, my the on

the your from immune in with higher trying step-ups that contextualize problems stepping the just really in those seen I'm point very you to close have are back dosing haven't point the other advanced to you trials this know you're age that other Thanks really dosing to costim costim you similar the whether to going trial? mentioned to respect much. Could whether whether trials? PSMA you're levels trials. on You at the please comment other your to have

George Yancopoulos

programs That's at same have of sort we we advanced, until to the was we good levels, tumor class What T-Cell varies activation can immune-related sorts amount events of this immune-related costim or depending these studies, the won't And the we the fair adverse I and in lead whether associated on preclinical get associations that itself. more is not. events of the of to so and same adverse those a referring when do very question. are are sort to the earlier type efficacy stages, know on

adverse would Libtayo combinations they So with based other stages are this different are point. Those dose where at on full though ratios that of immune-related in now we to expect right all-in see events. programs

Ryan Crowe

Okay. Thanks, Shannon.

for question. time more have We one

Operator

from Our Akash last is Jefferies. Tewari question with

now Your line open. is

Akash Tewari

switch this inhibition natural the I at have observation in when I'll guess up. there much. with Hey, with Thanks. in thanks had one guess program, acquiring at your myostatin you combined partnership program so via data development. obesity Regeneron currently is it showing any maybe the interest the I time? Is ADA a doesn't synergy your or GLP-X. program BD here externally for

George Yancopoulos

or described recognized focus on and you Well, long programs or weight increasingly agents And we've what muscle mass these they setting that patients. on of in is, loss. maintain settings there's in investment our that obesity these very body body composition amount detrimental be the maintain of off lot we particularly being for that say therapies very a to over-time challenging which they causing mass can can changes had do we yoyo lead would But of or these substantial can you of new preclinical particularly obviously, losing even debilitating on that as is lean as are stay muscle and muscle obesity actually large think are that a loss modeling. is the of said, if in mass we've quality shown types and patients grow prove this treatments -- really various weight that many may in can be and can them, that

strategies growth prevent think opportunity our is and a very are new exciting weight concerning seen class is, can the to agents. muscle of to being So loss of which about with or side some obviously profound it we combine that effects these preservation biologics

we'll be everything on so updates approaches time along. providing goes we hopefully, very And can And as our that are we actively imagine. pursuing

Ryan Crowe

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

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

Operator

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

now may You disconnect.

Regeneron Pharmaceuticals (REGN) 3 Aug 232023 Q2 Earnings call transcript