REGN - Earnings call transcript Q2 2018 | Regeneron Pharmaceuticals, Inc.

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Operator

Welcome to the Regeneron Pharmaceuticals Second Quarter 2018 Earnings Conference Call. My name is Sylvia and I'll be your operator for today's call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session. Please note that this conference is being recorded. call Manisha turn Regeneron's Head now Relations. Investor will over Narasimhan, to of I

begin. may You

Manisha A. Narasimhan

be Sylvia. you, second An webcast under conference Pharmaceuticals and days. XX quarter call. our will Events this for of Thank archive morning XXXX Good welcome on website available to Regeneron

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

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

Leonard S. Schleifer

us measured those translating good important Regeneron on and second delivered R&D to webcast. our products. quarter, Manisha, discoveries well progress, reflecting successful strong as into Thanks, our morning commitment financial today's everyone has joined new drugs commercial results, discovering call who a and as to both by as and

with allergic in drug efforts highlight pipeline development, drugs has candidates diseases Our you XX some or cancer. good across now progress in George pipeline. and our will and our notable R&D update progress particularly on

cell squamous line. Operationally, Our top preparations results. cutaneous Praluent, commercial EYLEA, Marion a will of our ongoing market on the launch and record launches Bob and update we on our review bottom Dupixent, the Kevzara, will you both cemiplimab, PD-X carcinoma. inhibitor leading are and these had performance ongoing progress. for efforts on focused our in

like to I'd So over now turn call to George. the

George Damis Yancopoulos

and Thanks, Len, morning, everyone. good

on you Let EYLEA. status updating the by begin me of

we would announced United achieving AMD, at weeks new formulations during August weeks gained EYLEA to the including next in the after of date with Commission higher under participants FDA. the for approach of or letters neurovascular in of Our second review week outside of or patients the more, with an were an regulatory many macular XX treatment XX% currently their European a interval advance XX X clinic EYLEA allowed XX patients in submission the XX wet gained is some Yesterday, who in based to These XX% report not interval in hope with Bayer, the XX. AMD. aflibercept for extension EYLEA study. the States, interval on review is results with wet year approach data average or of which age-related patients have of the interval has studies, into weeks injection dose FDA ALTAIR dose injection vision had of patients success the the been early of preclinical from enabling degeneration, submitted largely which of every results The for We maintained weeks, regularly study, like approved that letters, maximum XX XX. commercializes PDUFA new recent which more XXXX. These to of also study. at Study the scheduled

also inflammatory Dupixent we and and the presented now expect as our and next approved adolescents. Turning at be review dermatitis based other treatment for under Dupixent diseases, Dupixent, biologics allergies. for announced is atopic to license we blocker, interleukin-XX eosinophilic with this for detail SBLA approved in of also later conference as immunology inhaled a programs. known in esophagitis, month. or X data the our regulatory top a in May. atopic for asthma, and for diseases, nasal dermatitis, positive application as well more will dermatitis supplemental inflammation and is line polyps, on asthma is and Type adolescents allergic These is interleukin-X atopic under with investigation year atopic food medical including data for adults adults

well interleukin-X to grass support central clinical as of emerging earlier drivers we Later X in allergic both atopic in polyps and from continues in eosinophilic our nasal we Phase X dermatitis Phase program addition, asthma. as this studies initiating we results the our will be in In Dupixent and hypothesis allergy interleukin-XX studies esophagitis, are conducting The pivotal peanut both clinical are year, that and our disease. data are expecting pediatric programs and allergy.

Genetics combination has certain and our an be in Our Center. as target work may Interleukin-XX Regeneron Dupixent with from interleukin-XX and program by supported is complements diseases potential and Dupixent. done in inflammatory important monotherapy both at evidence

asthma investigating and We atopic currently in this are dermatitis. molecule

Now I'll to continues enormous area for focus of us. to which turn be immuno-oncology, an

the development Our this cutaneous If regulatory antibody a observed cell cell October. for Despite BLA for be the many in date and the under reported under Non-small respond. an PD-X the squamous States. the than patients approved have third rates have approval is PDUFA antibody will among field, first that for approved, solid currently carcinoma is for is antibody currently we efforts application gain also cemiplimab in and a review only squamous with PD-X and in response in cancer, less been cemiplimab in outside cutaneous Regulatory cell opportunity regulatory the there the cemiplimab. squamous non-small in cell review carcinoma, lung United cancer carcinoma is highest half important are where tumor. cell first-line PD-X to cutaneous one lung

are development with We strategy high patients both that and of a pursuing broad PD-LX. cancer low in levels lung encompasses

size remain lung Beyond on cell basal ongoing including studies monotherapy of cancer, quickly our still our second-line also Based from We other ongoing treatment readout the competitor non-small that field how any larger PD-Xs these being on lung cell lung cancer, immuno-oncology implications many non-small at and advances and second-line have on reviewing may edge. in it have carcinoma. cancer of lung program. the cell we are also cancer, to leading non-small study patients and recognize We're our evolving of we plan of developments Phase cancer, review increasing first-line cancer, recent in the data Despite without cell X cervical all committed treatment solid XXXX. options. in the to the tumors, is expect effective in

and which the build a to combination To we variety We're therapies combinations also exploring to have expect in with CTLA-X, development. our two inhibitors clinical tumor that In additional upon end, as and addition we in vaccines self-therapy to foundation use of inhibitors, checkpoint monotherapy, checkpoint collaborative we types. approaches. cemiplimab be address LAGX

our another antibody bi-specific proprietary strategy. key platform component of immuno-oncology Our is

checkpoint other set for Having are immuno-oncology tools combination antibodies to combinations agents inhibitors. We our broad each a particular single bi-specific enables with in ones of best the investigating with disease. as and choose our each in us within

has program a XXXX. by both us the whole. observed confidence owned and to-date this strong as the which aggressive encouraged very we studies is advance rates to in into response in concept remain indolent lead lymphoma, platform the We and non-Hodgkin's program a in wholly given Our CDXXxCDX have registrational molecule, bi-specific and validated that expect

medical a Additional from this this year. be program conference at will and later studies presented data

additional advancing bi-specific clinical also are candidates development. We into

with monotherapy development Our this cancer year. myeloma and MUCXXxCDX combination be clinic ovarian with studied development has clinical which our enter into of Early both will bi-specifics bi-specific will year, CDX the These bi-specific we we new and in study for advance cemiplimab. with entered to expect as later class cemiplimab. entirely as the bi-specifics, combination of multiple bi-specific clinical well will as antibodies, next class in an for BCMAxCDX

to now for Growth antibody fasinumab, Nerve Turning pain. Factor our

We are program. the Phase patient continuing X enrollment osteoarthritis in

Monitoring in study Following our program. forward with lower are the X quarter. from we later Phase an Data first this efficacy top this independent sharing Committee, moving by an osteoarthritis anticipate evaluation dose-regimens only We line results

to programs. stage like our a brief three provide Now on earlier wholly-owned update I'd of

with me begin Let our antibody. CX

both toward with and study to will on dosing sufficient option vivo hemoglobinuria, to this significant regimen high provide we In that is require ex the be goal achieved dosing Phase device, doesn't X hemolysis self-administered, subcutaneous believe delivery pharmacodynamics subcutaneous in with pharmacodynamic made paroxysmal prevent that nocturnal and levels convenient, of based PNH. or a a Our progress our patients assays we goal. volume blood patients have

initiate studies in data report to medical plan X for conference expect and We XXXX. to an early PNH in the full upcoming Phase

are rare fibrodysplasia antibody to ossificans the investigating progressiva. disease called which early-stage Another Activin-A, is molecule exciting we in and devastating our

setting our in with our muscle and pleased an translates wasting, studies muscle is of demonstrated in to potentially study ascertain that in antibody plan whether are studies to to X% enrollment We we also myostatin mass. multiple mass increase antibody first X studying proceeding the Phase atrophy Activin-A where our year-end in plan. pivotal We in of the We're according by increase in approximately laid initiate in this we early these combination metabolic in year various development. for the Each our to that six in out into the functional track advance goals candidates have us product New at that by say into the that remain benefits. pleased to of Tarrytown, currently beginning XX in discovered candidates new I'm laboratories the We product four we was XXXX. of stages to York. and/or of on are clinic clinical muscle

alone, Just half have call in three With of molecules into over turn the that, to clinical I'd advanced the development. the we like year Marion. first new to

Marion McCourt

on XX% of to everyone. U.S., George, second increase the EYLEA, like and to branded morning year-over-year. global quarter, the quarter committed position EYLEA the where identified market-leading EYLEA start I'd second and which for net In billion, growth market good anti-VEGF Based currently be of were sales XX% U.S. market. X% the In approximately continues growth million, Thank retinal $X.XX were in we've net sales has with net EYLEA sales, anti-VEGF the with you, represents We're an diseases. overall $XXX our opportunities. branded U.S. EYLEA meaningful maintaining to leadership year-over-year.

diabetic large are While a in in of current diagnosed remains edema macular XX% EYLEA attributed edema clinically significant well diabetic is than patients with XX% Less many eye anti-VEGF U.S. use others macular penetrated EYLEA receive business to even with Approximately in currently patients edema. is therapy, diabetic disease. of and diagnosed. AMD, diabetic there macular wet not with opportunity

television retinal grow Additionally, wet prevalence. retinal eligible ensure the because diseases, AMD, that and expect ever EYLEA treated aging end, be patient is due optimal to increase U.S. diabetic the majority initial of To in in branded wet is an like in substantial with cases, population, disease in market to the for weeks, therapy. diabetes the We'd we launching of multiple diabetic DME which, to in we AMD that or test therapy, markets. with coming vast in anti-VEGF the will in campaign

EYLEA additional and driver retinal the is approval growth label. gaining in diseases important expanding Another for through potential

estimated complications. It's diagnosed for diabetic with EYLEA study vision-threatening X.X We without in who report approximately and in population. we line for top risk top later positive at million are DME. an diabetic have in the million this sBLA XX-week to submitted PANORAMA approximately disease data are the patients X U.S. diabetic there and data from are retinopathy the X year. year have reported Of that line these, greatest this EYLEA retinopathy retinopathy we of Phase Earlier expect burden people

currently submission every weeks regulatory EYLEA Our for review. dosed XX under is FDA

wet for George this As regimen regulators mentioned, extended in dosing European approved earlier AMD. week EYLEA an

a in pre-filled sBLA We have with submitted for syringe also potential XXXX. an in recently EYLEA launch

were sales Turning by quarter sales net collaborator XXXX, our net Sanofi, now reported the were in the to as quarter global U.S., million. Dupixent, second In the second $XXX in of the is been million. up XX,XXX total Underlying XX% Dupixent the have U.S. $XXX quarter. strong, demand patients Approximately in prescriptions with sequentially U.S. launch prescribed last since approximately from for Dupixent

encouraged important U.S., been component depth disease and in by prescribing Dupixent impact patient indicator patient remain Dupixent remain with the other satisfied continuing prescribed Consumer coming weeks. as weekly through of were quarter and markets. referring launch. an is U.S., treatment the the unbranded prescribers activation approximately to patients, holiday demand, our of highly week. to education healthcare major the average Dupixent especially frequently increase. branded to another the persistence New excluding XX,XXX second have state comparison in We've Dupixent drug is NBRx plan rates roll and of underway starts, television lives the and and the over of providers practices. to atopic of refill to Dupixent that XXX in patients Overall in dermatitis the the campaign biologics. multiple new transformational of launch out In a awareness the their Outside campaign is second Dupixent a in high, their quarter,

the Dupixent XXXX countries in over anticipated second launched approved in launches Japan, was of with During remainder other and the and thereafter. additional quarter

lung candidates. clinical there for PDUFA U.S. asthma, look XXX,XXX in on treated asthma we in improvement the severe accounts in moderate Based Beyond decrease rate, with FDA's to who a estimated believe for and considered XX. adult consistent differentiated uncontrolled profile for appropriate atopic which Dupixent offers are unmet date forward be approximately severe and remains with for adults substantial on asthma, that a of Currently, our uncontrolled the we are an data, need Dupixent patients. clinically meaningful and dermatitis, adolescents, biologics among asthma, therapy October in to of function. a diagnosed There XX% significant would in who patients moderate to asthma decision biologic exacerbation

However, of these with fewer a currently than XX% biologic. treated patients are

reported are study pediatric we net representing ODYSSEY addition, as regulatory anticipated compared $XX and, Dupixent increase we outcome potentially for esophagitis, opportunities as Global expect pediatric a label recorded and the in positively also submission impacted. and year, positive of atopic have quarter guidelines this we In late-stage second anticipate which Earlier second all and the in the to in nasal XXXX. U.S. made included eosinophilic Over of for sales be and asthma, polyps, uptake adolescent in XX% million, to meaningful data by are both at Praluent, dermatitis, from as the were to development. cardiovascular are change, Europe. time, the Sanofi, commercial outcomes data quarter

that net pricing. more so exclusive inhibitor chosen Express effect to Scripts The access. the the PCSKX is was decisions us to too We're on we of access price payers We continue criteria with for patient to physician the took discussions return made. Praluent and second to in it management early This simplify lower July is affordable be in exchange for announced competitive flexible prescribing agreement to impact. assess as engage formulary. the improve a yet straightforward and utilization in In on that many would we with national space patients X, for quarter, the for Praluent pleased

minimizing related patients. to other engage continue barriers committed with and payers affordability remain and to access for We to

Moving million by demand global the were quarter in net improved. sales, to Kevzara, recorded Sanofi, second as as $XX

pen. only a pre-filled syringes is patients pen that the dispensed RA pre-filled launched Kevzara is now of available over in has a in uniquely and IL-X share in pen subcutaneous was that share pens XX% and biologic is the injections. Kevzara shown by launch-to-date. activated have therapy The Data pressing U.S. the the now of Kevzara TRx NBRx pen by button-free against chronic approximately Within subcutaneous the taking skin. RA preferred Recently XX% class, are

biologic strides We to to its improved patients clinical of those who through of mechanism for responders understanding action. profile, make with the IL-X positioned the Kevzara or preferred to are in class TNF continue antibodies. intolerant be Along is growing inadequate differentiated

improve market to estimated but antibody. like for of an I'd this advanced commercial cell access continue cutaneous with coverage. be turn and We're market, approval If cemiplimab will this the We squamous preparing for an carcinoma. squamous now in XX% third first approved, PD-X to antibody cemiplimab, cutaneous to having launch our to lives anticipated cell later carcinoma of year. PD-X the

Our PDUFA October based the is launch. Commercial for and our trained date in field U.S., ready prepared supplier oncology the ship in is Agency first following the Medicines XXXX. we expect to specialized and European of by decision In half immediately approval. is team XXXX a

cemiplimab the record the product As a Sanofi, sales. we U.S. will in take where is reminder, commercial a lead collaboration and with

Now over I'll the call turn to Bob.

Robert E. Landry

good morning, everyone. Thanks, Marion, and

As financial strong Len year had our as full items. bottom referenced Regeneron call, line change as at details XXXX of our results, well the results. quarter second I'll financial discuss start guidance of the Today highlight top this and XXXX to line

For the billion. EPS XX% year-over-year second XXXX, million. to earned our on we non-GAAP a net income net diluted of and year-over-year non-GAAP These and grew income, $X.XX in share $X.XX of results increase revenues X% represent Total respectively. per diluted XX% quarter $XXX

the collaboration U.S., year-over-year sales, EYLEA's the targeted In antibodies million $XXX loss of we quarter which the physician the practices, Ex-U.S. inventory with compared longer experienced the offered U.S. which EYLEA decrease connection one- U.S. revenue months second primarily Discovery collaboration Continued and to commercialization-related the that for as the of XXXX favorably EYLEA to States normal quarter XX, week of gross Bayer increase our sales, of are of million discount the of in of profits quarter compares comparable offset for our $XX quarter the as quarter offset ended deferred first of no June expenses, in payments, reported ex-U.S., Dupixent XXXX and of Praluent, of Total million connection to recorded for expiration our quarter The first and of consists and product months which of million $XXX in U.S. are to revenue net partially to the of $XXX year-over-year of and XXXX X% EYLEA on in first immuno-oncology recognition XXXX. immuno-oncology. the higher compared year-over-year the net a this by the in in to of the decrease $XXX the net EYLEA both two-week second Through Sanofi partly XX%, modest item represents net revenue $XXX percentage months performance of was by sales was revenue of Development connection ended Kevzara, the regardless XXXX. $XXX quarter drivers as commercialization Preclinical quarter from Regeneron-incurred the we no Discovery the from million remained the the by months Sanofi XXXX the December a collaboration realized second Regeneron-incurred commercialization period Dupixent, quarter. within grew three Sanofi our losses product Agreement million having XXXX, sales growth derived increased the an EYLEA our sales both of with Total compared XXXX. second contribution associated distributor million, XX% revenue relatively with in compared yet in June range. revenue The this connection ended of antibodies. of in and well of Agreement, of increases growth. of R&D increased existing on XXXX the ex-U.S. Offsetting increase Bayer, reimbursement a XXXX. a in EYLEA, second XXXX. Preclinical share decrease the to resulting six in outside $XX a million in of million, losses upfront in $XXX reimbursement XXXX, higher XXXX. from three million the of XXXX with the $XXX to share continued XX, XX% grew versus second Development from Total as XX, quarter Sanofi XX% reimbursement with included in EYLEA line constant United XXXX, and from the XX% R&D for XXXX, June recorded basis was which We with for Sanofi remained commercialization compared to growth revenue collaborator revenue under of and EYLEA which year-over-year second million volume. representing of remain the were these ended by is in expenses, operational $XXX increased share three encouraged net basis. against June a the investment reported ex-U.S.

XXXX of the $XX for million Antibody quarter during of levels the quarter loss reimbursement $XXX from Additionally, second compared recognized research we of the Agreement second second and we XXXX. of XXXX. development with Regeneron realized the decreased $XX commercialization reimbursement Dupixent quarter quarter million versus of in a License Collaboration antibodies and million second of less loss expenses connection the In a in to XXXX, under

global Praluent, loss by primarily Sanofi and regarding commercialization for Regeneron touched launches attributed both products. of increase Kevzara net Praluent. comments to lower a sales briefly partly Dupixent, Dupixent and want I Kevzara, was earlier, the share in product Praluent, have I and higher commercialization ongoing make and our and of Dupixent, to share the the alliance with As an few worldwide expenses. Kevzara, associated commercialization expenses for of losses on of offset lower

with Dupixent We are the pleased is such and atopic U.S. beginning profits realize for certain that in in alliance the dermatitis as indications, to markets

spend launch incurred portfolio. ex-U.S. U.S. In continue launch the on addition XXXX, to still expenses across expected prelaunch the for alliance asthma other the and to in new However, half necessary are indications the to alliance markets, first profitability. launch incurring alliance's and weigh new the expenses in expenses we significant these of related

alliance to as in half collaboration second expecting XX the to across diligently opportunities. indications expected of to approximately XXXX, ensure to and portfolio, and prelaunch incur we support are markets these beyond. of investment expenses level have launch in the markets and We as appropriate working the additional new Sanofi XXXX for is well the For launch

we As collaboration's to of alliance products the the improve sales profitability. expect grow, to our continue

expenses clinical to the result developments cemiplimab expenses, of non-GAAP now R&D second and million and XXXX. fasinumab were increase million in partially development the R&D of XXXX the Dupixent $XXX to for of expense costs, Turning non-GAAP for quarter in continued compared the facility-related second of quarter programs, development for was $XXX costs late-stage higher programs. The offset and R&D head discontinuation and count decrease a certain by as

primarily the three non-GAAP Discovery for XX, half the R&D months end Agreement as higher the months XXXX. to by The $XXX which expiration million Sanofi research R&D less and our and the development three reimbursements for total Preclinical R&D at increases Antibody calculated collaborators, compared ended year-over-year activities were this Our the wholly partnered owned million was expense, expense programs. GAAP increase is for Almost from the of unreimbursed is to of XX, June June attributable driven remaining $XXX XXXX XXXX. ended of and

$X.XX of previous tightening our to unreimbursed billion to XX, previously $X.XX XXXX, expense the $X.XX of quarter expenses and EYLEA R&D adult non-GAAP an unreimbursed $X.XX of includes expenses second Primarily increase lowering program, the billion. $XXX billion million due million in calculate R&D the asthma. guidance range quarter was SG&A XXXX we release primarily The to and $XXX billion expenses to announced cemiplimab are guidance June non-GAAP press XXXX Non-GAAP the modifications prelaunch for expense. Our ongoing expense our compared to commercialization-related our due for Dupixent as for XXXX. to ended be of and from three full the adolescent year for were information NGF in months required to for in in second SG&A higher and to

to be and billion Given tightening of from expense year item year-to-date activity was Sanofi found for billion we billion Sanofi to reimbursement SG&A a second $X.XX million XXXX. spend, billion. XXXX commercialization-related $X.XX to half of collaboration Regeneron $X.XXX XXXX the full $X.XXX non-GAAP second quarter expenses, $XXX are revenue, within projected line

our guidance $XXX to Regeneron million. be million tightening XXXX are from million full million to We expenses $XXX $XXX commercialization-related reimbursement $XXX year for to of

adoption primarily Before within line and This recognition turning we of equity taxes, XXXX realized securities due $XX by compared of million as corporate by the the from the the second primarily partly operations U.S. debt to of on reported for quarter the income Act, international item. of related see Tarrytown of in enactment change. the XXXX. lease million also XX-Q impacted of XX% XXXX-XX by driven compared which the on driven XX% tax for XXXX, in in quarter and income unrealized extinguishment ASU last second second to XXXX of the year's Jobs details the to to was effective compared was our With was we Cuts second the other gains lowered quarter to of other our more transaction. is expense Please rate. XXXX. other Tax attributable year-over-year the improved rate was regard quarter on loss taxes, our which This the to second to $XX the realized tax in XXXX, to of quarter rate having that results The expense

XX% of some law, to to including our our in assess previous the of guidance items, the of XX% continue be from now tax to tax XX%. to rate year XXXX we the we XX% full effective full range new onetime impact expect As

effective teens. years rate tax be do tax high lowered our been guidance While for our will in effective we expect the rate XXXX, next mid few has that the over to

law, tax of our other or could impact new rate. we the guidance passage regulatory recent still effective that the Given are tax future awaiting

capital balance securities next flow Regeneron net marketable the cash expenditures. We cash provided calculate in excess and of for sheet, second of less million of $XXX as flow generated XXXX. by and Turning of months XXXX XX, to ended $X.X cash free operating with ended and free cash cash June billion six activities the flow quarter the

million XX, ended capital ended XX, expenditures months for XXXX. totaled Our $XXX XXXX $XXX the the for were six million June June months three and

year We from our Manisha. $XXX to and full the our like back turn are tightening range $XXX guidance million to lowering call of prior expenditure $XXX million to XXXX to capital million to With million. that, I'd $XXX

Manisha A. Narasimhan

Bob. you, call end We the of remarks. for the Thank would prepared this open Q&A. our now to Sylvia, like concludes

Operator

Thank you.

question-and-answer the our Robyn from We first comes from question Citi. will Karnauskas now begin session. And

Robyn Karnauskas

the us bit Hi, us meaningful market's have around What a And little Thanks. pain stats for this coming a low OA I in you're might data's you be population. question. guys. of understand and dose. just market my the very that – within Thanks given so be just drug soon had help up this clinically understand some could OA, maybe you help would taking complex, question, where used the data? maybe

Leonard S. Schleifer

Thanks, It's Len. Robyn.

this based on on the as armamentarium I pain is think program considerations in to along would, non-opiate that about addition a all useful that's the a efficacy osteoarthritis, that what program, the anticipate, and we data we've been said especially would therapeutic have alone, efficacy Compellor is class. efficacy and new (XX:XX:XX) we demonstrated be good pain,

this wait course, not see show data. of should that be X something have we the anticipating is because that only safety, the won't long-term it. we're we can So safety, from the data safety, this is some to for have we which answered obviously, efficacy, but, long-term Phase The study our study,

a that dose committee we was the continue. lowered independent appropriate dose As the you felt to to know,

the to pleased program program. continuing. and Compellor know going this all wait promise long-term to our just (XX:XX:XX) it's is till But that, with have So data we really to have of exactly we're

want anything. high-reward you think to add don't I know I So program. high-risk, remains if it George, a

George Damis Yancopoulos

think it you've I No, covered all.

Manisha A. Narasimhan

next please. question, Sylvia,

Operator

Our Jaffray. Raymond question Chris comes from from next Piper

Christopher J. Raymond

Thanks. Hey.

of of their So gains of of sort put as pre-filled talked think a as sort lines Lucentis about market and Roche has therapy. share syringe all key component it, I driving across they

similar last understand think, for XXXX EYLEA, a I sBLA you're an for guys talking I launch. So you quarter, filed about a but probably device

there any dynamic, countermeasures then? as guess, that competitive So this just And can it saying? And, of maybe is differentiator view and now for Roche, between your talk first about then. you between are and employ Thanks. they're a is the all, I big now

Leonard S. Schleifer

shift that not depth seen Marion big think as to go on share. I Maybe have this into market wants that. a we in Yeah,

Marion McCourt

to. happy Sure,

And in has survey see lifecycle growth physician both from with would it we're opposite brand, taken suggest to Lucentis. Avastin. In use XX market equal about data points, fairly of over EYLEA and from the certainly the we share comprehensive share share, of as we've prescribing, EYLEA the continuing LUCENTIS fact, that grown,

clearly, it in as and showing, and we're preference, the having showing, our that mentioned think that while – that that extension in helpful having syringe as negative delivery it to for my be physicians. do is and line be in – and, later will the in we're we we're a any system certainly competing, will as So extension, share performance marketplace don't is available AMD potentially to current in EYLEA prescribing XXXX way see in physicians DME. profile with we a believe I the comments, important pre-filled We growth wet as

Manisha A. Narasimhan

Operator, next question, please.

Operator

from next of Lynch. Bank comes Our Ying question America Huang Merrill from

Ying Huang

for my talk affect about of Can increase? the would program cell not? arm, Is Thanks cancer. enrollment? And question. morning. driven that lung to PD-X by on the or also KEYTRUDA this it the in non-small ask it whatever Maybe from good powering program you. the comparator you rationale by behind Thank availability enrollment one I in Merck you've the increase the in want in Hey, taking your learned assumption certain (XX:XX)? progress then of Is or driven markets,

George Damis Yancopoulos

Certainly, good own answering compared the robust the a control not with cell, job as than is did was effect the active, more antibody you but robust in first-line question. non-small the relative in very looked study. agent think PD-X to second quite the study positive study, second data Clearly, I the your smaller the the Yeah, study. original

so those results, the And based our our adjusted, on power we calculations size of study. and on based

terms account So it of you as out territories we of basically certainly, described. where, take course, we studies what our where in and is entirely available, them. we care carry was enroll standard of how And in into and what's different the

it. So, about that's yeah,

Manisha A. Narasimhan

Operator, next question, please.

Operator

Leerink. from Porges Geoffrey from comes question Next

George Damis Yancopoulos

Are mute? you on

Manisha A. Narasimhan

Geoff, you. we can't hear

Geoffrey C. Porges

there. Hi,

outlook to flow Congratulations as gave understand and Because the half think Bob, about as financial look line value what to and first And really collaboration variance QX? you the sort year. more the financial commercialization a to it getting we're and what's of that then, the you simplify going just free I costs investors for of and second of reporting there more and more collaborations you cash more and And you what of your do puts we in could that that, gets the of of to on you us over A the more losses consensus is the importantly, place. more takes results. anything each Sorry change and can QX? is? number have complicated, lines But so related driving those that the compared terms the confirm all more couple in think was report? that. you these are in and expectations questions is of to Bob. cemiplimab,

Appreciate thought you in which it. you about have any way can So things? simplify

Robert E. Landry

the Yeah, question first. last Geoff, take I'll

big detail On meeting regards JPMorgan As with that. the constantly mean, is and my modeling there and documents you your with between flow, in consideration best, to to We no and doubt do will question, had, interpretable challenging things to by dialogue regards take team cash complicated. value make at a QX know, to, it's we first which just kind pretty that company true in our out inclusive the of me There's regards under statements. of to at these we I getting we've of the post financial difference the is to regards giving obviously, concerns looking your comes Len into do the to continue January, with continue and QX. with

under We had you total, quarter something out and XXXX $XXX $XXX at going roughly in With that, XXXX. did Geoff, in to think line. cemiplimab, discussions XXXX, split, quarter are we why QX we're put million, date. we'll XXXX the we of no regards to more the two QX later along had how million regards with tax that and I in first a show payments meant we to of Thanks. versus which exactly is still $XXX that million at time

Manisha A. Narasimhan

operator. Next question,

Operator

Stanley. from next question from Harrison Morgan Our Matthew comes

Matthew K. Harrison

talk view you bar you Great. to Thanks. this of I you And are molecule? about a inhibitor appropriate or you your to how comparing CX develop look the Soliris on and that as what sort question the to on is XXXX? this Thanks could you think taking you at ALXN what's going the talk maybe If develop market's talked the about. questions. just morning. for blood sufficient, Good level Can about ask when

George Damis Yancopoulos

we're and to as of measures evaluation of compared well our talking about we're how well on Yeah, pharmacodynamic our assays the using in based well, our inhibiting what's known domain, molecules doing at complement. as public our own assays

to life important it's and with data. is control What in subcutaneous easier integrating convenient all a provide out keeps that there self-administered home less of their a regimen makes that better So that's patients lot see breakthrough. disease we that with their

control. make So delivering we're lives while trying their easier better, and That's to goal. better disease our

Leonard S. Schleifer

complement just measure we can determine we an to assay not blood with take that. the suppress familiar our that blood in suppresses patients of if achieve the and was aren't standard people to fully level We So activation, wanted. only very ex case whether see to levels vivo out a what clear, in and blood for blood whether saying. We be that achieve what assay we do George

good a and will expect be that's hope predictor. it we course, the Of disease, but same quite not thing a as doing

Manisha A. Narasimhan

question, next Operator, please.

Operator

Josh Our Evercore from next Schimmer question ISI. from comes

Josh Schimmer

questions. quick taking the for ones. Thanks Two

and been JV reverse it have commentary loss, is on greater losses profitable? expect do the towards kind with quickly half eventually that be expect Thanks. the towards when then to and the SubQ second guidance, CX injection? trend become commercial that declining of First, that in the but looks to will dosing return on what the it you Sanofi based so, the temporarily may If And the to you correct XXXX? do anticipate will trending antibody, it of frequency like you improving the for losses

Robert E. Landry

Marion second And to we competitive to going profitable. guidance your when we asthma half alliance give, very Josh, take direction. second And, to away. the right to question. the profitability the a of again, of us class, think very, very support, successful comments not note. the going on the collaboration to spend, to to in it we're we need to given directionally be regards enough of that I'll turn Again, with gates and not launch behind is very and guidance a is strong give very quarter And in ensure, Sanofi has antibody, quarterly, that terms to right yes, first with our regards made we're and trending support we our point, going it have in the are we my going that entering come ensure enough that strength the that were crowded is with out

Leonard S. Schleifer

see that intend weekly first as that So have comments and there the that's reflect (XX:XX:XX), subcutaneous our And be more are we regimen we Whether would that, the able think in typically others to as what move now, far that, a can dosing although, we're achieve go dosing forward. just to this. minimum right one a as interval, than obviously, we'll likes study. than get dosing. longer we weekly to acceptable to more and the insulin But way into

Manisha A. Narasimhan

please. question, next Operator,

Operator

comes from question from next UBS. Our Gould Carter

Carter Gould

taking that you your question. what you Len for And think indication Thanks higher aflibercept the work, out your the could get think moving that, you to? interval initial you George, mentioned morning. get and potentially from guess, the you. do can how forward Thank on and Good treatment any for do dose I fast market?

Leonard S. Schleifer

probably a the with dose would that is We've diligently Carter. bit comment experience extend the these to we don't clinical. more we preclinical of something and we want I to Yeah, a the types early doing go think amount come into that both have that a too up that, so formulation that. it's field, half-life. of about studies, higher and competitive It's Obviously, much worked a tremendous think little in to

Manisha A. Narasimhan

question, next Operator, please.

Operator

from question Nadeau following and Cowen comes from Our Company. Phil

Phil Nadeau

to significantly? for so in And as Dupixent of patients A launch there Good Thanks atopic to in congrats that on and talk for prescriptions that doing any trends progress. taking grow what eased, notable allowed the Dupixent to you Dupixent QX? ensure Was dermatitis morning. Thanks. on in question as that you are about then you question the you new launches? anything reimbursement my reimbursement, that prepare trends, access the saw can asthma, in

Leonard S. Schleifer

I mention life is addresses it makes maybe are was really, we want didn't to who Marion why enough hear disease felt the and patients miserable of us us from the of before access told for feedback we're continues all be just us us So issue, People with and sort that we are what to say satisfying, that and to what changing continue – doing. this reminds really doing them. have

I've that it seems in data on previous have are kind that you so, an saw trials in basis we nice the well that patients of be calls, experiencing we that to benefit saw in our and clinical achieved predicted. real very the individual is the would said on as the world where data controlled the And setting translating

I said the and are we've So thank that extremely is people. effects very also And and, patients both new the concern doctors seen goodness, nice. no as to satisfied before, side

the So also very good. world real the out tolerability is in

thing and that driving growth biggest continued use there can I blocking Marion tackling is likes. would the is my and, probably perspective, address that's and if guess that So, she course, of from the

Marion McCourt

in XX% for atopic Sure, payers lives. Dupixent dermatitis, give if for happy of coverage covered following little XX% percentage lives the bit Dupixent topical to we to to. with a on more over And today, among have – access we commercial over give specificity specific, access medication. get a little of or bit more the two have one is XX% and the then But you numbers, to only about commercial

insurance did and another one the second quarter picking made companies. in the as we progress major up well progress of meaningful we've significant some So make

tremendous not as But of in increase in toughest such TRxs that of demand think their Len's the in I tremendous quarter-on-quarter progress. that are move value demand – into moving say their this additionally to in XX% the to prescribing. and type I starting also comparison, seeing referenced severe, really would physicians the driving what the that quarter, good results is So comparison we're because feel are and was what seeing, is this into about Their moderate that that the of XX% quarter-on-quarter patients only course seeing. I cases more first we really number in coming now cases, the but point, the

severe in home, my As a or product characteristics that much I've payer that of with mentioned the feature referenced, the in second comments, at we A discussions very to asthma, will it is the We consistency George Dupixent forward as function profile moderate is differentiating are engage see to I to administer course, we to clinical is differentiated able look launch. keep certainly the important. lung and important. in of seeing in a to self the some impact for we're really, really exacerbations, also reduction is and, also that distinguishing and and at differentiating that mind. important will that characteristic really also time by relates in appropriate asthma, think patients in our The profile be

So time. we certainly We're the we ready at with engage look launch. right will and to forward payers

Manisha A. Narasimhan

please. question, Operator, next

Operator

from from Our next question comes Cory JPMorgan. Kasimov

Cory W. Kasimov

Hey, my taking A follow-up Thanks question. good morning, guys. on Dupixent. for

curious of that with specifically far, asthma? patients you more thus in Thanks. product those treated or that so how allergic disease XX,XXX the the proportion of overlapping co-morbidities? common of even sense the commercial terms good setting of have is. have the out been maybe So do a have this in And I'm

George Damis Yancopoulos

controlled the to the our more patients – patient their as told provide know serious severe have more think Yeah. to just say tend put and, studies Marion I atopic studies controlled on from data, the a I'll their now, real dermatitis collection don't are doctors moderate or we patients first. serious you, of our world but we

one more been co-morbid population happening had the more actually other to order allergic have the XX% the be to co-morbidities. our had co-morbid patients might might asthma, XX% condition. of you severe what's world, So least controlled of studies in at XX% and real think on in XX% moderate and who to disease But

is allergic very dermatitis So, co-morbidity with to a the obviously, there the atopic other severe, among moderate of conditions. population, substantial amount

Manisha A. Narasimhan

question, please. next Operator,

Operator

Our from comes Geoff Meacham Barclays. next question from

Geoff Meacham

in a post do just broader XX on populations, you how today the you months And expand access think ask the to you Want and to guys. a class versus would Thanks. cut price then, Thanks, overall, Okay. into for population? Post ODYSSEY some ago? what Praluent. point characterize tipping is

Leonard S. Schleifer

Thanks for the Geoff. question,

answer being out et the removed. that that sense documentation, think are that requirements et complicated improving, barriers the cetera, I definitely for in there, access cetera, is is the artificial these are slowly questions,

station. that saw we Express at where to a they physician Script, think a went with short I

But – where cardiovascular with that coming people I will disease inhibitor. get can't point, actually tipping to variety practice tipping be existing point, an be, practice, of optional, we'll think, of with a it. sort I I PCSKX the down patients from it think not others guidelines who will but the will when come appropriate the their demand a sources will it expect be That therapies, go practice will may guidelines that to see. LDL to have probably will they standard to level be moving Thanks.

Manisha A. Narasimhan

please. next Operator, question,

Operator

Luchini is Capital. from question from BMO Matthew Following

Matthew Luchini

Hi. thanks and taking for the Good morning question.

over you of answer severity next and going terms a curious color of X, You bit to are XX types more think questions, disease evolve more you. the if receiving Thank patients in months. Dupixent patients how expansion to touched X, you I that moderate the was but of on into this is little in the provide could bit a on last the one

Marion McCourt

it's that toughest some experience in patients. physicians not their their very, very So I that think unusual of try first will

been So the earlier have that launch phase. would in

in touching who performance, prescribing are give now nurse of I hard But by and at into move relatively depth As XXX,XXX who moderate experience. evidenced their we are numbers a patients disease to already PAs also we physicians XXX,XXX broader and That prescribing, to starting as physicians NRX into we only It's shared, numbers who seeing more use that patients. TRxs improvement percentage I through said we through if moderate that have severe prescribing have we in they that a the probably would small Dupixent, that, and really of numbers U.S., see the severe now evolve Having as practitioners, from are have. to are the of thinking discussions evidence back that. don't times you to we on exact were depth. potential patients roughly in know

potential lot atopic in do we and have work dermatitis. to lot a more for So Dupixent an awful more

Leonard S. Schleifer

Yeah.

you remarks help should I help. think that that. anticipating least in achieve referenced DTC should our we're earlier, that your that that Marion, At

Marion McCourt

they for them to evolve to and on-air campaign, be and Yes. the educated, there. coming the we many a it's patients the our state right patients, mention lot, awareness. seeing are be additional do as We've launching on-air website, that And many, shortly. We by response get care been Thank even awareness campaign are you, just to the Dupixent into support look touches then very by campaign they disease covered we were because to that to to engaged going had state information Len, clear, for nationally forward got great and evidenced the mentioning a patients having they because much branded think and physicians we efforts the so disease need. time that to TV

Manisha A. Narasimhan

please. question, next Operator,

Operator

Our following question comes Baird. from Brian from Skorney

Brian P. Skorney

questions on morning, for fitting the quick me Good guys. in Thanks couple a pipeline. with Hey.

it seen compared could antibody, the On far do mean, CAR-BCMA, BCMA with just more so about you the I the the the subpar BCMA make results CAR? just given competitive And what we've IL-XX get a think Thanks. antibody pathway Would plausibility just there with much bi-specific ADC bi-specific COPD? around I role REGNXXXX of target to for a COPD signal a IL-XX make in Dupixent, for IL-X, IL-XX. is versus your on wanted just potential the thoughts COPD or for better to bio

Leonard S. Schleifer

George?

George Damis Yancopoulos

is data, from models animal I but the two certainly certainly, well, closely more there's versus no not in much question bi-specific compared of but from the CAR-T activity certainly pre-clinically. type There of bi-specific activities. also classes. that ADC certainly Yeah, is And quite to them only approaches different a think pre-clinically bit entirely CAR-T compare of an others, And approaches. we us, the

be activity up soon very to of bi-specifics program, with it's classes we're will also additional now, in performing are be patients. the we its to start we relevant I way that there. potentially excited we our in seeing terms going And, well to how combination bi-specific coming as hopefully as very going BCMA tune very finer see also or approaches mentioned, to what as amplify of have BCMA of it about in terms So a

about that So we're very program. excited

of call a is setting for how what number about field syndrome. asthma they There's be doing In what some that this we're COPD, have about questions biologics with so-called the terms of substantial to thinking that COPD COPD and exactly now, the implications And dupilumab now there. the of and I of in IL-XX questions think so in of of the the a overlap out of all we're overlap, are patients biology, what in with lot really terms pursue in the there's also figuring COPD terms of there right and genetics, a going lot some to the exactly right

Manisha A. Narasimhan

Operator, next question, please.

Operator

Our following Goldman Sachs. Flynn from question from comes Terence

Jason Jakoby

Jakoby is This Jason Terrence. guys. Hey, on for

dupi. on one another Just

potential adult help it's versus the expansion Thanks. XXX,XXX? next think where said atopic year, So the about in U.S. population derm I this you like for think the can just numbers, you've adolescent for patient the with us numbers

Marion McCourt

not size more the Yeah, We much this on population. and We to to Marion. (XX:XX:XX) have of would actually potential this future in very area in certainly is adolescent there. the patient happy look the provide launch be insight yet forward specificity given very

Manisha A. Narasimhan

please. question, next Operator,

Operator

Adnan following Our from Securities. Butt comes Guggenheim question from

Adnan Butt

on linger memories that a and George, some indicate the channel Hey. of Thanks checks one question. with Maybe episode for taking EYLEA, EYLEA bit. the inflammation Len still

to potential EYLEA that you talked that resolved? something agents? is back have safety. is new inflammation the for rate clinical versus about Has think inflammation And be normalized you data? now So differences on different EYLEA Len, Do that could then,

Leonard S. Schleifer

course, don't in there's to and several at increase inflammation, we one certainly we it back. very monitor got that But XX. to on that we a To back Not there batches our do to to get no the when intraocular far variable, Yeah, best the quite so every as could the to typically up I two, of XX,XXX, you XX,XXX background doubt can't a one the we per seemed the are as tell trace of per looking spike. was can syringes. be injections. about what one doing certain. to in that you spiked But, say two a of controlled this we of trial, per above rate And notices lot. XX XX,XXX cases it of is is carefully. X But inflammations baseline absence the arms the The to can they to we two, think we ourselves or quite notice that to now patting and break marketplace one

we but down. We got I all team that leaders of We rate that the handled lots think shared that we it. we're various Marion's lost some key and our transparency the feedback. fact I'm associations the opinion of there. sure winning during positive think them got back, and out and customers that, because I the that was data we've transparently with the wanted ophthalmologic with to retinal groups. very see anybody who directly

a differentiating agents, inflammation yes, Now, new in could of factor. be terms

some the XXX, monitor, X,XXX that we're looking agents are we're per X,XXX, rates seen XX,XXX. rates newer one the per in XX think two as to about outside we I've I of – world XX,XXX. in per talking types at of per XXX in up Remember, to the of

hasn't an of coming from Europe that, study based study, So, rates where got to dosing, in recently we along data for don't that through but yes, have ALTAIR on people a approval concerned FDA is treat anything we just allowed extension and dosing we the were XX% those a highlighted, and be get see a seen the at the many we've that seen extend yet, months. of nature. highly And the where don't to competitive of be first that label and the X that end to of remember, our year, an regimen of patients the about in gaining an we regimen gotten, more, going from if look intended that, We able competition. think average George to of differentiated to interval carefully at an achieving the as very four the emphasize don't year weeks letters molecule. XX would down or come overly a I want say still I dramatically, about

number profile. anything have we we EYLEA the that we broad think can indications our certainly on incredible see profile diabetes. and has I don't So that very disrupts emphasis anything coming time that a that see for along don't And of long in have

George Damis Yancopoulos

emphasizing, things a experience, and think for yeah, forth, and that I and to question, so the that important. experience do And, think is the our readout raised, having obviously, how these it your sensitive the wealth I of such really about have you eye understanding is ability this, of track we the worth also point inflammation. it's

if and think to is a particular any that take the patient, a would experience into confidence the account they treating they risks have that in agent. have and the I physician

Manisha A. Narasimhan

All right. there Operator, couple available follow-up an concludes queue. a We're today. e-mail. calls. were that for our in know us I for call the Please send

Operator

and participating. concludes for Ladies you. today's this gentlemen, conference. you Thank Thank

disconnect. You may now

Regeneron Pharmaceuticals (REGN) 2 Aug 182018 Q2 Earnings call transcript