Earnings call transcript Q1 2023

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Operator

Welcome to the Regeneron Pharmaceuticals First Quarter 2023 Earnings Conference Call. My name is Josh, 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 Josh. this website you, call to world. your call. Investor our around evening good Relations earnings XXXX be everyone the welcome conference interest ends. available first for our quarter you archive Thank the Thank morning, will listening shortly Good of after afternoon An and to webcast Regeneron and good on

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

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

events any SEC whether XXXX, undertake morning. and its and otherwise. Securities a not from A Form forward-looking statement was found Regeneron States Commission, Regeneron's including to the update the forward-looking information, of subject period material can actual differ other new as description obligation United March risks and for this of that complete filings the to statements, any those future be more in to risks result which Exchange or is cause quarterly could results projected Each ended in statement. filed with events materially with XX-Q XX, uncertainties does that these and

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

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

Leonard Schleifer

everyone Thank and today's thank call. Ryan, you, you to joining

significant our is Following growth and off a pipeline advances, important XXXX, execution and and XXXX, achievements start highlighted the over to in sustainable prudent of in all Regeneron capital company long-term time. regulatory good shareholder deliver position to allocation, better commercial which by value

quarter Bob vision our earnings and of grow in simultaneously provide and a first will of goal In diversifying our meantime, long-term part while the Regeneron. for business few details on of cover performance our streams, our an to moments. George, continuing would Mary update our is revenue which I

have We toward made progress goal. achieving that substantial

years, past revenues in the revenues to nearly revenues total the for XX% accounted first of four compared XX% Over XXXX DUPIXENT, doubled, year of XXXX. the for our total total have compared XXXX. EYLEA of revenues revenues while for XXXX first in to quarter Sanofi total the accounted primarily growth of of X% XX% the total in of quarter only by Driven our only of our collaboration

diversification of trend with this expect along to continue. growth, We revenue

share milligrams, is is X expected assuming launch milligrams which and aflibercept become while milligrams our example, aflibercept XX contribute X to to revenue overall to EYLEA successful of of PDUFA For approval X expected smaller a the date, revenues, has growth. June a

represent believe our IL-XX additional of X significant as promising approved a former smokers inflammation, type up patients well III DUPIXENT XX% accelerate positive global diversification. as results net of itepekimab in basis across on product subpopulation as the the the a quarter, the year mode, Phase to by COPD sales indications. well In addition, in high-growth growth prior opportunities evidence results revenue compared for X growth currency DUPIXENT in constant to for with driven We as remains all with antibody

top Our full make therapy that cancer. have non-small to is an line, and last global with the melanoma our LAG-X lung where we oncology to non-small lung studies. in Moreover, with meaningful believe also potential of we and advanced already a the antibody, in rights year's cell to portfolio fianlimab, in pivotal with contribution become cell acquisition combination our of Libtayo, to cancer, has both Libtayo starting Libtayo recent important to advanced launch chemotherapy in combination

data presented in for Updated late-stage We We are to linvoseltamab, the also year. on for myeloma seeking be quite remain ASCO excited emerging BCMAxCDX will BLA approval upcoming track this Meeting. profile later submit our at clinical bispecific. accelerated which a the about Annual

We invest and in and organic expect it deliver will new our will medicines continue to engine differentiated development time. growth research drive over that

of cancer; drive our development nearly Our diseases; and and and and to metabolic revenue growth, in pipeline dozen Decibel different medium- bispecifics as expected are collaborations X co-stimulatory in our broad and as pipeline early profitability with Our many Intellia, modalities, long-term notably: well therapeutic others programs Alnylam, cardiovascular spans areas diversification.

that to Before our the Chair. like to has to I'd a take contributions moment that to served has over Dr. as nearly three Vagelos recognize the George, handing Regeneron he made Board decades Roy over

XXXX, Regeneron Lead the be current roles serve appointed Poon, board Director. be will will At Independent and his Board he he the turn in continues month. George science addition as we work to in to years, world-class next as to our the invaluable since the member term from Christine I to that current by co-Chairs, provided board's Roy medicines. time, into and and Board ends the inspire will retire appointed has company, Over guidance as a us after of

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

George Yancopoulos

you, Thank Len.

multiple Regeneron programs. the medicines positive oncology The first as new COPD significant pipeline, from exciting our well progress to XXXX DUPIXENT for in data quarter delivered of collaborations, our from Phase and for landmarks as genetic III milestones our

to collaborators, and significant results announced for COPD clinically a decade. Sanofi trial we of immune our with that produce DUPIXENT together action statistically first the meaningful Phase March, In III in DUPIXENT. with over was Starting a in treatment mechanism

type to demonstrated reduction trifecta life deadly moderate a as lung exacerbations, enrolled benefits: an disease in X function of Our a impressive disease. potential COPD well in XX% of patients improvement evidence severe and with quality treatment as this a meaningful clinically in significant DUPIXENT-treated BOREAS patients for inflammation. paradigm-changing trial

forward Meeting We are late-breaking upcoming a American month. to BOREAS at later looking Thoracic presenting results the in detailed the Society presentation this

with also replicate next Phase We and results regulatory to expect study. for NOTUS mid report these the discuss year to authorities results plan exciting III

further with demonstrated our Regeneron in antibody, we genetic supported of proof-of-concept COPD address Genetics positive I loss in the by IL-XX to Center, III genetic supported analysis also would are with which which COPD role based overlapping Similar II on function Phase COPD. a This studies risk. approach trying is an reduced of is DUPIXENT for you data. in population analysis Phase that our remind from IL-XX benefit association

The caused DUPIXENT nasal chronic X exacerbated BOREAS can the nodularis. and X or by current including eosinophilic patients indications COPD inflammation, atopic type indicates data prurigo and that with rhinosinusitis diseases esophagitis more asthma, FDA-approved polyps, help even beyond dermatitis,

X tailor be diseases, an XX, for DUPIXENT XXXX, also FDA October type to inflammatory to are chronic this to we most with on urticaria other expecting continuing are development and DUPIXENT likely spontaneous to responsive patients for decision We method.

Moving to oncology.

milestones early to several and of pipeline, progress year. late looking we this forward stage are important with the With Starting Libtayo. our

differentiated that Libtayo lung BCC added CSCC. use CSCC with profile Libtayo expanded data, label guidelines supporting to and in addition in recently clinical these in was more updated to require In neoadjuvant for tumor recently commitments and cancer, The satisfying treatment NCCN post-marketing indications. U.S. approval its these settings was the all also full mature of

that perioperative could initiated will this, our spanning will are several were a in fianlimab, survival, LAG-X antibodies, triggered the study detail we cancer standard. year. exciting and already of at ASCO, pivotal our fianlimab-Libtayo and be presented produce suggesting further half in about metastatic patients, in program anti-PD melanoma data melanoma, longer with Starting Libtayo. Regarding adjuvant in our monotherapy in indications. combinations a metastatic Based the start the These new which have trials rates broad pivotal by robust for we first-line double confirmed melanoma on planning response with the efforts which progression-free we the with and second combination

on small pivotal treatment In and a in we soon will we a seamless for Phase study metastatic the cohorts, data based study II/III started patient start lung II cancer, addition, Phase promising cell in of setting. perioperative non-small

tumors, data for unresponsive cancer, the which this initial solid the being PSMAxCDXX alone. and Next, Libtayo. for in with bispecifics immunologically cold in costimulatory year, prostate tumor first-in-human Libtayo with positive combination to type combination GU therapy bispecific in considered largely ASCO's anti-PD-X Earlier advanced our are represented investigated

plan been have improving antibody, potentially present this our during to several for severity side advanced Libtayo. EGFRxCDXX time more XX anti-IL-X which with Over of in updated prophylactically our will bispecific, while present data of ovarian cancer types the antitumor co-stimulatory PSMAxCDXX the plan in Also sarilumab, patients, well in both data from MUCXXxCDX treated or maintaining costimulatory in tumor bispecific MUCXXxCDX in bispecific next activity. some effects as our receptor our or months we combination reduce frame, data to immune-mediated as to with we

linvoseltamab continues bispecific favorable these for updated show multiple dosing Annual myeloma the ASCO this the second with year We for pipeline we believe schedule regulatory at potential multiple efficacy, relapsed/refractory tested in candidates. half to for submission BCMAxCDX Meeting, late-line advance. oral best-in-class States oncology a competitive a the linvoseltamab, in has hematology in remain treatment will safety present an and of upcoming our the We In in on the Our track that differentiated will data of myeloma. linvoseltamab. environment presentation data United

in CDXXxCDX optimized follicular these generic follicular submissions without track bispecific, improved initiated which for has have we lymphoma efficacy our our this for and Odronextamab CDXXxCDXX in regulatory in odronextamab relapsed/refractory on second half relapsed upon of complete profile in lymphoma safety to first-in-human a both step-up anticancer we EU hope potential benefit late-line DLBCL, or with impacting of diffuse bispecific refractory relapsed and or the U.S. has best-in-class For Also, a patients. our refractory odronextamab, study are year. B-cell could the and lymphoma large dosing our costimulatory efficacy. improve regimen combination further profile, we

collaboration genetics with Alnylam, Now with siRNA Starting medicines. our therapeutics. and to

Alnylam week, onset our and important update APP disease. Alnylam last we in an program early Just Alzheimer's for announced

sustained Alnylam a central the on silencing therapeutic details time, collaborators first system In trial. of siRNA this demonstrates morning, pathological provided the clinical earnings nerve call in gene in these the results. For a additional an our

aims have will and already a their as providing clearing they devastating families approach after to address protein formed, to production have precursor plaques Alzheimer's antibodies. siRNA disease, amyloid-clearing which of a even existing patients emergence of Our still with on potentially amyloid amyloid prevent opposed way impact new to the

sustained and of far. XX% in by rapid treated with cerebrospinal in biomarkers encouraging up single with dose-dependent, reduction single of The Patients as dose profile assessed safety ALN-APP experienced fluid. dosing APP so production to tolerability and is

of in to proceed Canada, While study nonclinical part already of the partial the on approval chronic enrolled. the patients States received United multi-dose B prior the due reserved is clinical A Part Part regulatory in had been hold to portion studies, majority clinical finding the has toxicology in where B trial

upcoming the results Detailed be an medical meeting. from will study presented in

are as Lou We additional for ALS well other other candidates diseases therapeutic Huntington's. and or options Alzheimer's to or many development neurodegenerative forward looking few disease, have for such that for advancing as no Parkinson's as currently Gehrig's the targets

broad validated liver exciting treatments diseases, of Phase targeted In with development central are NASH, nervous risk and We're planning nonalcoholic genetic multipronged addition developments as to II a approach and we in to to of ALN-PNP, our targets develop more or for ALN-HSD progress steatohepatitis. well. progress enrolling genetically system in continuing are medicines, including NASH with we these recently additional patients in NASH study continuing factors, our

therapies. of for cell Finally, pioneering manufacturing collaboration our commercialize biologics recently T diseases. discover, with developing approach receptors, human modified highlight Sonoma's additional and will the inflammatory like Biotherapeutics' together and fully and I T well discovery to autoimmune and to therapies reg for antibodies characterization with as develop gene our as candidates and our cell cell T This technologies collaboration industry-leading would Sonoma announced regulatory bring

Regeneron's In conclusion, truly in productivity continues and early-stage pipeline. R&D both engine its late

so Roy distinguished that that Vagelos hope his Before to thank continue to Regeneron of as as up us as I for call industry. set role many the across stage model turning well others serving would to can has high the Marion, the over I at for to we live career. for a like also Roy all over

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

Marion McCourt

Thank you, George.

quarter performance categories. Our demonstrates across first multiple ongoing leadership therapeutic

disease Regeneron position pipeline Taken across and brands together, areas. our near-term our multiple in-market leadership uniquely launches to extensive anticipated expand development

First sales-related U.S. On pressure. X%, quarter wholesaler XX% higher of by share product billion. sales quarter captured X% the impact year-over-year reflecting the higher volume, levels, increasing demand net offset and EYLEA first U.S. product net deductions sales EYLEA sequential favorable decreased branded to declined sequential approximately $X.XX quarter. basis, inventory EYLEA lower in competitive a

has underway, Based the with need standard on and X-milligram EYLEA, retina the improvements EYLEA and presentations less important as X more FDA forward exactly next-generation weeks has expressed following retina what date, with a X-milligram acuity a it when EYLEA demonstrated a preparations approval. patients X-milligram us treatment now well-established aflibercept aflibercept look as option have at visual the this of comparable be aflibercept treatment increasing trials and introduced in PDUFA gold to enthusiasm frequent changing in Launch community to paradigm Regeneron's to scientific portfolio meetings, clinical than the profile bringing about ago. decade we potential injections medicine. is to away. told specialists well they In was anti-VEGF are safety

which CSCC to in foundational Libtayo, market as $XXX includes from first On volume sales In demand and $X transition the U.S., Regeneron's markets. global advanced to grew currency continues million, international is XX% the net on both advanced constant $XXX net sales sales million a product reaching increases. to which quarter basis, grew in portfolio, Sanofi BCC lead Libtayo million. XX% oncology

new Libtayo patient academic of accelerated option, Following an for community of initiatives driven important combination and improve non-small gains have November's share brand chemotherapy cancer, lung cell first-line to the awareness with last advanced treatment raise approval settings. has physicians in access have FDA in both Libtayo as new starts and

$XX for Commission lung this chemotherapy in Libtayo positive basis sales with are increasing combination we the Libtayo to securing by cancer, currency access demand PD-LX Outside of approved the steadily U.S., new European driven recently net The on indication. grew constant reimbursement XX% additional country million, and a process for in and launches. and

DUPIXENT. to Turning

global trends XX% an ranges. notable all clinical profile billion, on by patients $X.X is real indications. There's Strong opportunity its a severe to net is leading its billion. on basis unique its uniquely all across of DUPIXENT mechanism quarter and age profile, older. DUPIXENT continue and systemic outstanding currency safe First and positioned and approved one $X.XX sales efficacy world to net In is prescribed based convenient and the also the X experience. constant months treatment new XX% disease approved across atopic and in increase U.S., sales In the action, grew treatment to X biologic growth significant safety of number for grew prescribing to market across moderate effective, indications. Driven with DUPIXENT volume for provide approved further penetration as patients dermatitis,

space, competitive leverage gain and is Across the Launch in our we ongoing treatment. In FDA-approved demand progressing we is to switch DUPIXENT majority and dermatology nodularis, are biologic continues capture asthma share need. from polyps the capabilities prescribing in growth to the as patients for as increased continues with prurigo only systemic patients well, of treatment. update commercialization anticipate on DUPIXENT allergists initiated market market also DUPIXENT ENTs. and nasal naive

Our launch is cytosolic esophagitis expectations. exceeding

embraced quality esophagitis. of in on of new of therapy. and meaningful analogists DUPIXENTas first year patient approval, life disease execution of need following therapy, than scientific patients campaign for is and the underway and care the treatment setting launch more Both strong have awareness have In improvements the raise patient symptoms Sanofi. our A gastroenterologist now demonstrating standard with in unmet extensive collaboration new to XX,XXX U.S. eosinophilic and those initiated advancements

driven our dermatitis approvals are prurigo atopic results to diversify DUPIXENT’s conditions summary, were delivered and commercial DUPIXENTnet a expected across in ongoing to to serious many launches on in by $XXX XX% across and currency growth esophagitis, constant Recent basis, indications portfolio young the eosinophilic in contribute children medical quarter. growth. continues the Outside geographies. new In and solid U.S., of approved European million, growing sales nodularis

Moving of coupled standards that advance serve of forward, launches the even by our to have the to care. with portfolio, driven more we strength positioned well anticipated potential patients existing are

the Bob. that, With turn I'll call to

Bob Landry

Thank you, and Regeneron's My unless on comments Marion. be non-GAAP a on financial otherwise will outlook results basis today noted.

XXXX in of first the solid quarter financial performed Regeneron results. with well

First Libtayo DUPIXENT quarter diversified as total revenues billion to to earning $X.X revenue and year-over-year increasingly X% increased streams. contribute and

net was income $X.X quarter share per IPR&D. previously impact diluted First of income on $XX.XX a of net which included announced billion, $X.XX acquired

Beginning Bayer. with collaboration with revenue and starting

constant Sanofi in $XX of Total grew million, first versus million net share product net million XX% to X% which First revenue was $XXX outside last quarter recur which year. basis included up million, XXXX first million U.S. currency quarter, the this on were versus quarter sales first ex-U.S. EYLEA our did and revenue $XXX $XXX that quarter related a XXXX. Bayer EYLEA of Total milestone sales $XXX collaboration profits not was the year's collaboration a

the profits of increase prior of million, $XXX XX% and the from an year. KEVZARA share of Our was versus commercialization DUPIXENT

expect our to collaboration begin process DUPIXENT. developed realize from see Regeneron for improvements new further expansion margin a increasing yield as to continue profitability from substance and manufacturing We antibody we drug

Finally, revenue U.S. related profits first to we absent recorded million any expect to do a contract. of not record the Roche a of new in XXXX, our collaboration gross for previously ex in share from Ronapreve We from additional contract. signed revenue quarter sales $XXX of Ronapreve

Moving expenses. now to operating

expanding XX we XX% and by in First The and driven ongoing programs quarter as to growing share XXXX development was XX hem/onc upcoming in Phase now well the III late-stage DUPIXENT which studies for company's approximately our continue XX% itepekimab year-over-year invest year. which programs R&D pipeline, than development programs to primarily encompasses studies we growth. to record organic result of the starts expected $XXX pipeline costs for development increase with as million in reliance and as for include headcount Libtayo this fianlimab funding of transaction. additional of full in costs higher expense as assets, increased now program, drive more R&D ongoing early our our related late-stage development These and a our study clinical

of year-over-year XX% the assistance to headcount $XXX costs, transaction. patient to increased expense contributions independent, and due Libtayo SG&A not-for-profit higher organization, impact higher and related million an to the

for these year, COCM other Sanofi quarter revenue shipments up Dupixent. ex-U.S. versus First collaboration recorded to commercial as Reimbursements XXXX of Praluent million, for revenue Sanofi in manufacturing in of part $XXX to of supplies are last increases costs respectively. XX% was due production costs and

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

We focused priorities, our as in on continued are allocation innovation, deploy strategically to to to on as and both have which deliver cash external, well shareholders. internal capital capital returning our investing

remaining billion purchased We shares with in the existing authorization quarter of million nearly $X.X our of as under $XXX March first XX. our

an add to collaboration announced Sonoma our new and discussed, Additionally, scientific approach a as George equity payment we $XX investing investment with Biotherapeutics, capabilities. the upfront to million through

some XXXX. and guidance conclude financial outlook to for like I'd select our updates to with

COCM for to XXXX reflecting of million to of supplies midpoint, guidance at million of $XX updating Praluent be increase ex-U.S. and million, are DUPIXENT commercial We to increased in shipments an $XXX Sanofi. the range $XXX the

collaboration reimbursed the of are expected the revenue, expenses incremental Importantly, of operating in from half as as with by other to Sanofi, resulting generally Approximately reimbursements a neutral recorded $XX impact million balance will be profit. Sanofi to be recorded Sanofi Regeneron's revenue. anticipated these XXXX incremental

revenue result, higher we revenue. other XXXX XXXX a be expect other than As now to

be revenue lowest second other the is quarters, second this the of be the other quarter XXXX remaining in majority For recorded modeling to the revenue with purposes, vast half of of year. expected to XXXX the

located XX%. start-up expected mix, product by associated well York. XX% our the margin with also gross margin driven be New as in primarily in change is between XXXX are updating an in unfavorable upstate an to We new our gross The change to fill/finish in as facility increase costs

XX%, guidance XX% compensation lowering are to benefit anticipated our rate the reflecting tax we deductions. previously than higher our Finally, for effective of to stock-based

company financial further in of results Regeneron continued growth of remains deliver in quarter the to robust year first drive well XXXX, conclusion, to and the positioned beyond. remainder the and the In

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

Ryan Crowe

prepared address question next. Thank the open to ensure each from Bob. We'd answer possible, Josh, like to we as to the able remarks. for as many now caller that our moving you, To Q&A. questions are before we one concludes call will

Josh. Please go ahead,

Operator

[Operator Instructions] Wells Bansal from with first Mohit Our question Fargo. comes

You may proceed.

Mohit Bansal

more dynamic Maybe, Marion, you bit. little a bit on at a could the this point if this elaborate EYLEA, little over

the is in that did share. weakness Decibel you the taking Given quarter, mention some

Is flipping confidence starts? you more do the you some coming of EYLEA a think of could level And share on along. where patient situation So is elaborate is once terms it switch? also from? in your Or if new it high-dose comes this

Marion McCourt

a as to happy the a I net decrease sales basis, on EYLEA, of quarter did with we And noted, look see we comment. X%. as quarterly Sure, EYLEA see sequential basis, we're I a on performance sequential product if very reporting at with did

but As competitive higher is volume. we we while on slightly had sequential I of inventory one, levels deductions. mentioned, sales-related reflected factors. by wholesaler was pressure It offset overall driven demand number tire lower it and also was a by Certainly,

relates certainly anti-VEGF a in of a would share in share particular necessarily XX% it that comment and product, XX% category, to over that I totality something I a we was category. quarter, competitive that overall the maintained branded will identify Specifically is at competitive it dynamic approximately, not with the more the I would this anti-VEGF pressure, believe say the competition. as we overall in

care I importantly, standard aflibercept of forward now, we mentioned away. about very weeks X as is certainly look So with milligram, And X to launching EYLEA.

Operator

Robyn Our question next from Truist. with comes Karnauskas

may You proceed.

Robyn Karnauskas

first-line going melanoma soon. data be having relatively and the to on thinking Just market and some questions LAG-X, about you're

buckets for into model understand this I be you the do think for what you multipart competitive? are to these penetrating opportunity success, better? to a us is when combination think, the monotherapy melanoma, And it's question. help actually buckets guess first-line how checkpoint So big What about for -- bar nivo the can you and

George Yancopoulos

profile, already overall we we we've close are longer based much standard two satisfactory new we a Well, this increases rate numbers that profile on to remarkable almost with these our come seen the near with country small reported, alone, response reproduce anywhere reproducing these seeing a had over establish the get along cohorts, PD-X if doubling but as PFS. will of which or results, entirely standard care in for believe an safety this we studies, safety anywhere favorable we disease. If

all we applications We're melanoma earlier large, first-line cancer as moving And going the -- and settings, so also is the also and lung know, adjuvant but other so including laterally neoadjuvant we're we're cancer opportunity very now itself. melanoma and additional in studies. forth into to and within already many be entering opportunity forth. going We'll

we So the approach we've already patients. to earlier for studies, it opportunity, we to major chance huge -- only data help in can seen these really that we this has and a consider a a if our make difference

Operator

Tyler Our Cowen. Buren with comes Van from next question

proceed. may You

Tyler Van Buren

discussions regulatory there is the left do have you started yet? front? EYLEA, to labeling And For high-dose guys on anything

the but to can you just for the the me to EYLEA first in your the for impact Marion, the and remarks, related prepared forgive briefly quarter? of quantify question And inventory follow-up, response lower for housekeeping

Leonard Schleifer

launch stuff. XX on to of the regulatory on you comment the don't hopefully, So on June can thereafter. to the the I'd and we we're looking like Marion, inventories. FDA say comment on update, ongoing forward, promptly the action

Marion McCourt

Sure, you can there. Tyler. I detail give the

XX range of three end to on quarter inventory our range XXXX. the of at the normal X in days, the related XXXX fourth the quarter of of lower days inventory the normal compared in levels EYLEA quarter to is the while question were the of to end first still approximately your within So

will impact in on $XX the do approximately a negative of as you all million. sales quarter I'm you that, when first net calculation that's And sure the do,

Operator

Our next with Terence question comes Flynn from Stanley. Morgan

Terence Flynn

potential just the with wondering for was COPD. given commercial indication footprint the there, on another for DUPIXEN, I

If any required think spend how there. you again, talk leverage additional that's on And the could about about to or maybe forward. just footprint

Marion McCourt

of wonderful therapeutic specialists amazing cover the indications, synergy. to very different as we think an DUPIXENT comment. is disease all we and and And there areas Sure, certainly with happy and that some

And nasal example our an potentially. polyps. with market you in today, And we're with COPD indication with launch give and obviously, asthma

we COPD, that, in look hasn't patients to forward with population. this potentially as As achieved way George important described, an a launch, a help been ever it's for indication really

also and you've So where specifically use the footprint, as the can respiratory in we'll very and seen we closely we'll we'll pulmonologists. covering in that an opportunity very evaluate very we that. of we us But where indications, that adequate, Sanofi, to some coverage done need have to But commercialization might with is important effort be specialists, dermatology existing our give synergy make appropriately and such assured disciplined thoughtful certain be you about indication COPD. additional

Leonard Schleifer

inflammation inflammation. a that, is diseases. related collection interesting, of to a collection unrelated it's fact type Marion, And And individual just that allergists add to X bit little diseases, understood to of X that it's a not type the seem have really the the of concept

to who will you dermatologists, talk concomitant speaking carefully, atopic for when day treating they that asthma was patient, an when and them said many I a benefit there. other to you look understand you have get people dermatitis, beginning And they're they're take have And polyps. an if if to example, nasal allergist the asthma, of

of think DUPIXENT all, dermatologists them is and ENT, covering and allergists, multiple So the really of are I some kind the said. to Marion we with pulmonologists, including as diseases. the them covering of And We're the are doctors, many main unique. talking the

Marion McCourt

COPD, too following as well. second have to the add in product a the here I'll DUPIXENT enthusiasm potential to

very will be this a patients. for future So area helping important

Bob Landry

team. back your So to on on have with the back. regards to question leverage, Nice welcome first you off,

going the XXX the You'll year-over-year our issuance share the the our to quarter, XX-Q of again, with the regards on with of for economics see half quarter points. basis morning pick transaction. And alliance, to up this that's antibody we're roughly

great continue see on with should comment leverage COPD the to beginning Marion's indication. that we're So really to in

Leonard Schleifer

future Obviously, in indications. closely the of with potential excited we very the say all of hopefully, work Sanofi current the fair I about for it's we're all and believe and, to these. future equally DUPIXENT And

Operator

Our comes with Sandler. question Piper next Christopher from Raymond

Christopher Raymond

another you talk to you I But mind. BOREAS about data, hoping the agency DUPIXENT you guys discussions seemed had alone. regulatory the interactions. I on from you if know pretty don't to that got have Maybe don't I the signal that when some COPD be with Leonard, were you question, that was think strong

the FDA maybe have second results you question -- cutoff one things data. when the this to drug our of maybe then to of can sort of value and out impressed. as been with or greater happens? patients part as They're consistent -- But of that checks that clinical about this is how XXX. kind it clinical arbitrary this low XXX that is, would pretty see communicating we've a And as heard KOL map is XXX anticipate add that with you them very maybe Just of discussion than we consistently once accounts asked

Just maybe to your anticipate take advantage thoughts sort how you and of on of that. this,

Leonard Schleifer

The setting, obviously, mentioned, statistical other and Yes. of their only the and Well, improve exacerbations, let what lung III where, and measures I functions we're life, regulatory we've -- we part aspect. improved at their me a all not with as quality staring start people's an were the these but -- of the we hierarchy. that also lung state positive mean that all incredibly is Phase function

So and when we it's commercial patient huge whether study I the is how be with you that patients you a how many Regeneron currently they we indications, a see filing. to Sanofi number, have this don't FDA potential very -- a and have like should a robust or discussing think many have, database but and about that something very so is know not large there feel that, I concur,

something you, for We figure sure update and something meeting, we Regeneron don't that. will out to a it's if communicate have Sanofi it's once any if definitive, that I'm have way properly

a In XXX. terms a I cutoff stick than the is larger, and which about. bit although mentioned, to can work of have where And cutoffs trial, I you, that's brought you antibody other what overlapping of IL-XX what the to But think about that, premature commercialize. other studies, and talk to you you say it's both Marion future you as a little with think that's obviously at somewhat potentially. gives something we'll population our in one George But look remind

very have So people been opportunity function. loss progressive to what of with patients, cover great many, many we really a a could has many, really unfortunate lung help

Marion McCourt

about on there you of Len worldwide, countries. as in we had comment, to that fill I March over XXX,XXX numbers XX patients talking can your of patients. in were DUPIXENT

Leonard Schleifer

Right.

So that speaks experience the post-marketing lot product. a to the of

Operator

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

may You proceed.

Brian Abrahams

into some Shifting APP opens the you partner, neurodegenerative that of level indication? what you I'm the of recently your confidence data diseases other program. your proof you reported this Alzheimer's. can principle mentioned, and gears, of beyond of curious in up quickly the How in expand this with potentially safety overall

George Yancopoulos

really game one this history the to able time I gene. a the think very degree, the higher-than-expected technology mean Well, high pathological been an changing. has that data we use silence, this important to is were that siRNA within human in first very brain levels exciting and

point you Alzheimer's way implications there for that. itself. application out, the diseases well. other of also disease, beyond CNS important this every as To could neurodegenerative are types But as Obviously, have goes

of we're Alnylam. programs with that a number working have We

with relationship exclusive them have all on of targets. We CNS these

work the to And this initial the from are we're of behind of based results exciting a as expedite into programs lot also we're trying on many our well. to trying clinic. clinical that And expedite them

this of not a addressing of opens entirely up diseases brain assortment So new think really way whole an diseases, just neurodegenerative neuropsychiatric and we diseases.

times. exciting in We're

to go have We cautiously.

sure. and the saw know to with very in forth, to doses so we can results, early a will window profile that that hope addressable therapeutic disease hold We're terms have give these safety all could be large days, which we We that this modality. the up. hope and of for a have But that low reduction we be initial don't the the of in us sufficient applicable target variety this of the lot by marked in potentially

Leonard Schleifer

friends add on to effect. at further that, being to by only our of will which some result, wanted think just I I data to speak channel, things: two different not streaming Alnylam, impressive the the durability So might but discussed a find you

by want quite as said, a to be other echo George tremendous by clearing antibody is Biogen, one results really comment And even recent things important. to said. of with amyloid the to going adjuvant, still But The something of are burden disease. Lilly I plaque previously, the really there's George Alzheimer's

be is is seem way, production the think, maybe not the I seems that seems said, with over. of to amyloid that ongoing to process another the is speaking is the amyloid, process way as to speaking of to having antibody pathologic be what towards George generating, be ongoing, even data, us. the the what that amyloid But a role is more deal stopping data upstream, advantageous which And to perhaps

Operator

Richter Sachs. comes question Goldman from Salveen next with Our

You may proceed.

Salveen Richter

the with high-dose fit? discussions of formulary on with the becoming forward give how revenue any share EYLEA think and color payers So here can us on here, to about you to regard larger

Marion McCourt

So and in for levers that launch launch aspects are then of all all actively getting activities. includes ready preparation. associated premarket the elements Salveen, activities And we certainly, and involved with

very in the they important will that other organized have payer with efforts. payers times, at do customers be We appropriate team. sophisticated most and market access, launch a be place in pricing involved And will our definitely and

is customer over customer we potential base a very our and forward of this approval with to and EYLEA, know experience all activities FDA Additionally, so working launch our with from well that we stakeholders. look decade a

EYLEA. importance also of I'll the their terms enthusiasm opinion the come visual for they've and safety in for retinal duration of patients be profile know acuity, with have product again changer key leaders mention to and a the game they a space can the really the and prescribers that in

look So the enthusiastic and we're we'll forward launch and very be to ready. opportunity,

Operator

Tewari question next Our Jefferies. with Akash from comes

proceed. may You

Akash Tewari

X% what Any half how high-dose at hold the going start it launches? market potentially XX% back or quarter, share in the EYLEA, $XX inventory EYLEA parts price. lower clarify should price of was moving U.S. grow on to on then there impact should impact color expect the a again forward, to loss, EYLEA million on evolve net So the was we as market and just and to 'XX? a additionally, share And

Marion McCourt

of take let some the the is was you mentioned. to in jump some height calculation would I share that decline but So exactly related But me first, to that the quarter, of in shift items, too. and correct. There say the not others to not here, want some market may

described, When X-milligram market, first a it cost and the of, I entirety the is variety launch. is low period, our obviously, very very for the look more performance a as as to and in strong we of competitive competitors, EYLEA market planning future today look a at situation others. shares through aflibercept portfolio quarter then And overall,

can't shortly, and launch to specifics inventory, the you hope, approval. the gave on we overall category I that on preparation in our the related competitive coming for pressures transparency then to and pricing do up number. calculation FDA give next some of overall net, I specifics As our following think that But the you to we item

Leonard Schleifer

as on Obviously, basis, modestly mentioned, was up. Marion a sequential demand

the were So by that obviously, offset Marion to. we factors referred

Operator

from question Chris next Our with comes JPMorgan. Schott

may You proceed.

Chris Schott

maybe the just I that those on, guess, And the on had guess agents as how DUPIXENT you've we success in at increase I with results all the just, your kind interacting of design overall? question program. study IL-XX X think just had little you space confidence I of and in a kind COPD. about just bit with kind see your elaborate of

George Yancopoulos

Yes.

that that Genetics had, would actually obviously, data saw We factors. particular human in made DUPIXENT decisions, with activity are also have study based the And more to from we strong of Center, genetic our particular was Regeneron population on where the activity. that a our the lot particularly and COPD very led it of all us evidence of all of patients we do suggesting optimistic,

into criteria, gives all and And forth approaches us confidence well to and plan fact confidence it everything the same design IL-XX. so and gives one remarkably same success that IL-XX that approaches we so us with worked the to the certainly, since lead all of so -- use same the the that our will study, went that

really with outstanding, in function you the results well life these as patients and hit life. a quality a really difference mentioned. as unless of endpoints, rarely but active for improvements you were of reduction exacerbations, DUPIXENT improvement that as for quality lung their agent we've have feel in The other Not only importantly, all most these important can meaningful function, really we their already clinically hit the

genetics very the strong. With is IL-XX,

a have study Phase III subgroup in study It We in Phase the we're that doing II in. group. was that the

no help has to mechanism drugs We XX% study. be a DUPIXENT population brought We unmet think population. of really action long the we have an very, already these have for high chance make patients a need huge this really that time. demonstrated This reduction will difference in a for had overlapping Phase very new of II to in population exacerbations a our with

long IL-XX. with another this a hit We much hope. for make could And have who one Dupixent, hoping with without for to one such population. huge It for make and patients a these have we're big difference been difference this suffering could so really

Leonard Schleifer

on wanted just did said And is way Phase what that's hope how a probably is out. II today. a still And was for done target to some saying it's worth have based how was time. drug turn you your your yesteryear, and that you, you and I indicator Phase II, I times, to fourth the identified an it maybe or III Phase did repeat, but obviously, George you maybe X you biology X development or Phase going it

But our we that block and top is it certain to and it the what treating? to you of a say, of can that look if that insights layer mentioned expect you're with target genetic a associated target way validate that and sort George going reasonable beneficial you're effect? on disease a in have Is unique is

we've in added X I People fourth us Regeneron we comment medical, a a anonymized the part if worth this sequenced can George And I you it world, a information. of think confidence about but gives lot, information. that's how it's done, sequenced that when think in said them George genetic you all can medical uniquely with have the saying that time. of and this really know That been number large people ask I coupled many times, get respects, I'm know

that done? in use work how George, doing so identify ways, only diseases. but we're validate we much have We targets, not to specific the specific targets, many in to

George Yancopoulos

sequenced. been have who humans the all of half about seen We've

Leonard Schleifer

confidence think than and And is anti-IL-XX. So did we perhaps had what of I hearing that's large why DUPIXENT database a that's with mean, that that, now millions. is I that more you're others with

George Yancopoulos

What from COPD, do for this it identify drug works. know we DUPIXENT, little Since or pathway. is COPD a just [Indiscernible] type what the bit, were patients. particularly exacerbation genetic mimic expand we of variations of showed those type DUPIXENT, genetic mimic protected that let that it blocking a you And people we how X the X the for variations

with the was very done path the case. turned IL-XX, genetics. predictor. activity as disease. said, it's we of a have pathway. where Len or powerful genetic the the out blocking IL-X/XX increased And I variation the human with we've thing, at same mean very, associated be more that Whereas It's to And obviously, mimics pathway exacerbating

is secrets one our a going I've have in as use forward. that of ability said, the high rates decisions to And our as we make studies success this is our criteria to to

Operator

Securities. next Our question from Yatin Suneja with Guggenheim comes

proceed. may You

Eddie Hickman

could guidance if the FDA you Hickman on the program the talk the trial Yatin. at wondering draft Eddie I for is on on your all? This outlook impacts from high-dose was if And that about designs? anti-VEGF

Leonard Schleifer

impact any program. on on our us, don't I think has that

Operator

David SVB comes question next Risinger with from Securities. Our

David Risinger

your I launches to please the U.S. expectations prospects the discuss guess ongoing you. term, Thank including had after you your Regeneron EYLEA the diversification the Len, HD? mentioned opening EYLEA in straight remarks sales the company's go the EYLEA. in near growth revenues you franchise from question. of I'll total just for away Could

Leonard Schleifer

We be go specific the that a of said, since me you give EYLEA ran over measures On the our company. Marion for future question. will Let has the answer sales. franchise on combination basis, we're to time milligrams guidance a aflibercept X right qualitative to anticipating that the growth don't of right and quantitative

Operator

Oppenheimer. question next Singh Our from with comes Hartaj

proceed. may You

Hartaj Singh

you Really on question ASCO, we And data to at it see data, the would submit duration FDA from then patients and you like data? interesting ASH. present quick to ranging, what can Phase a I you linvoseltamab. At a data. any ASH, ASH? presented go what At see? your dose were dose Will And before be expansion I application? ahead these expect guess, Just should the and then on also

George Yancopoulos

more actual you're will to was submit to little going that update data the see be the our hoping II to further BLA. think for an I on pivotal actually our maturing, we data, with a FDA Well, the update bit a Phase to

the time very we get the will all be matures. better will We with as Because think and rates close. data patients. even better response these forth data you know, get these follow it as as So so But safety data are in from at potential to pivotal our results the have we'll going the to as best-in-class based believe efficacy, are show show what dosing as study we the upcoming well the favorable on ASCO. that schedule

Ryan Crowe

time we two questions. have think more I for

Operator

Carter question Gould with comes Our Barclays. from next

You may proceed.

Carter Gould

Sorry more as going simply, market guys that highlighted Was that? it to characterize the you Or permanent what's you in Or would belabor EYLEA. guess pressure around I a just dynamic? forward? landscape pricing that QX. something that seasonal

Leonard Schleifer

to the answers back that that, to come particularly because excited just one I'm story about. Marion want a little it's BCMA I Before bit,

become clouded you at which terms the one Regeneron first in claiming very of and and you're think I put another field, to bispecifics, bispecific and has it's has got you've initiated to was so biospecific into what somebody and the sometimes thing look compared differentiate to we claiming a by hard using the obviously space. were competition what on and patients, forth. The so

molecules really not see are could But not created for think if created Antibodies you Bispecifics you to BCMAxCDX potential are all equally. take the the equal. a dispassionate and best-in-class. view, be all differentiated I program, a

You all created Clinical equally. trial and do see differences. programs not

think is compare. and careful you a at This very I'd look to encourage really one

that. was Now Marion, going you're answer on question EYLEA. some there to

Marion McCourt

And back competitive dynamic question on the and to your Sure. pricing getting Carter, pressure.

go corollary the then time, been I increasing quarters, and forward. at dynamic, think pressure. and extent pricing to look over back it category does at if And multiple go you anti-VEGF a competitive there on that that look would has have some

we alternative game is not a want really in VEGF patients. product was for just that product a rewarded it right? EYLEA a remind to share And and launched that for all the but the what product category, in low-cost I in profile. costly, very was a the look as difference low-cost at category least like profile the prescribers is But long that the and category, very time, that and the been was There's alternative, very, being made changer profile

in be pricing FDA going experiences. marketplace But we continue always at point, clinical pressure important will the forward, is to and what's a important patient and to dynamic interest product look profile most aflibercept that has attributes that strong certainly So X approval a your the will bring product category. But prescribers with milligram. the this new as for very into following

Operator

Our Evan BMO. from last with question comes Seigerman

You may proceed.

Evan Seigerman

feedback on color hearing regarding to on how some it approval they from love using to you've some expand dose. physicians you have been plan the the I'd as of comes June. X-milligram assuming and Maybe

Marion McCourt

updates team, obviously our the more actual marketplace opportunity a as comes the looked with use an the will physicians and work to be We on course, have So at important into data even clinical prescribing have product done it patients. and the specialists. of select lot of with medical

to give a And your for there's are starts, be when there's it's I opportunity are a to patient to question, physicians Certainly, new you deemed think answer range. variety early patients very appropriate attractive. that And considering candidates. an of

obviously, a naive you more gives new the also their a product that obviously patients durability but We injections gives eye future, know duration? that EYLEA don't it safety in they that portion anxious you like the acuity need are to but Because EYLEA, to. benefits the to have and in patient are and all becomes, strong question of you start than of physicians and patients a the wouldn't have with today, visual why

you maybe for to But in give the and some might them controlled EYLEA, cases, if area a in category, acuity patient another category. duration. like opportunity product anti-VEGF well on very the of maybe you'd that's anti-VEGF is another product have maybe visual Similarly, another product, the and, duration in that improved

for or switch market I of say be helps, might we you I when that specifics can forward I potential for experience. look patients to interest the day it's give broadly who So well. patients, the as would patients combination for anti-VEGF category hope new the and

Ryan Crowe

thanks Marion, the everybody and remaining in, in we apologize not who in to your Regeneron. and We to to for to. those have did you, a queue interest dialed Thank that chance get

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

Operator

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

You may now disconnect.

Regeneron Pharmaceuticals (REGN) 4 May 232023 Q1 Earnings call transcript