REGN - Earnings call transcript Q3 2018 | Regeneron Pharmaceuticals, Inc.

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Operator

Welcome to the Regeneron Pharmaceuticals Q3 2018 Earnings Conference Call. My name is John and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Please note, the conference is being recorded. turn Relations. over will Head Manisha I Investor of now, the to call Narasimhan, And

Manisha A. Narasimhan

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

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

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

Leonard S. Schleifer

Good least a sales such Relations, EYLEA has call. joined her does who Regeneron at fabulous important an morning to delivered at third should the name we Manisha you. Manisha the In It's grow. progress. Thank get financial Investor pipeline everyone Narasimhan. job to right. results, record continue quarter,

surpassed approved For sales recently billion. worldwide time, sales $X.XX the billion. third Also, U.S. its quarterly major exceeded first $X time, Dupixent first asthma, for quarter EYLEA the was Dupixent And second for net indication.

Libtayo, immuno-oncology approved launched first therapy. we our Additionally,

into many the of with build we entry half additional first intend upon foundation exciting and commercial the For we significantly strengthened diabetic for formulation advance of a less clinic expect dosing recently multiple the Libtayo, agents next the which we in to in area first our the approaches to a expanded is aflibercept EYLEA, and for retinopathy. indication fast-evolving through potential immuno-oncology, frequent cancer a new into of And year. the in settings. and high-dose franchise label different

recent label. it potential. up asthma, differentiated that with Dupixent Dupixent a Type and the positive X spectrum for in is Phase allergic that launch with product, of and to responsible Compared as eosinophilic in in biologics a together atopic robust rhinosinusitis living and pipeline dermatitis, approval, described validate results The is to esophagitis, profile pathway the the has positive for other Phase approved chronic have ongoing asthma a results a hypothesis We or polyps, scientific X IL-X/IL-XX and diseases. X nasal

will the on You'll atopic about from in launch asthma George and dermatitis, more and Marion our Dupixent you clinical update of hear programs.

our We that have our treatment LDL for PCSKX class. the continued cholesterol-lowering to will products. updated use Praluent, other guidelines support be greater lipid access U.S. shortly. the From facilitate anticipate antibody, hope steady progress we make guidelines updated with lowering increased commercialized will the PCSKX and We of

and the gets Although is cause it number prices, in the one the that United the cholesterol fact death drug a cardiovascular cardiovascular disease. is major drowned cause out States, debate disease in high about LDL of of remains

have a advanced clinical continues six to-date, new a bispecific early to to advancing to clinical and I'm goal the molecules pipeline molecules Our to leptin At four progress. a cancer, antibody set happy that into for new year, development. new of an we the of These four into antibody beginning ovarian antibody a CTLAX. development. agonist, we already pain, receptor for include report

advance seven approved to into myeloma. XX antibody pipeline has our expect clinic BCMA now spanning range the We have a also product and drugs of We a areas. for multiple candidates CDX by therapeutic clinical year-end, bispecific

the now molecules George. of were I call With our scientists. these All discovered to turn over that, by will

George Damis Yancopoulos

Thanks, only AMD. whether AMD optimally our which after XXXX. supplemental on from anti-VEGF of with I'd treat to (sic) XX of an without in of severe dosing the EYLEA March In diabetic mildly diabetic top data the In severe study, offers edema. was or the use for XX accepted wet age-related is line X May every sBLA retinopathy and regardless patients fixed-interval License] wet date X to with EYLEA EYLEA. year good morning, Biological require based with for that dosed X, from non-proliferative XXXX. approved now August, weeks. our retinopathy diabetic six-month sBLA investigated wet [Biologics sBLA EYLEA they PANORAMA PANORAMA in one the September, or macular This in FDA action drug announced Phase Positive Len, were or everyone. in flexibility macular the results weeks like begin for was the (XX:XX) treatment to Application in therapy of the patients, effective EYLEA degeneration of

weeks couple time a same Just data positive of from announced this study. one-year from the we ago, point

period, monthly by respectively, XX% scale or and on a from one dosing X.XXXX. with to compared improvement On baseline severity XX-week patients after were the only results receiving injections. the p-value the experienced patients, X- statistically primary greater XX% followed endpoint of retinopathy diabetic two-step treatment, highly XX% of or The at initial every year sham than every less significant,

blindness the patients threatening complications results of Strikingly, EYLEA asymptomatic treated who earlier achieved compared reduced the diabetic significance retinopathy by or age adults in disease. key XX% What the of vision. that retinopathy sham XX% development to previously working serious perhaps in analysis, on secondary the macular hierarchical to patients EYLEA vision Regarding Diabetic edema first threaten can underscore at the by edema. year of pre-specified with went potential EYLEA XX%. These within cause and which United underappreciated vision-threatening States. two statistical is value of non-symptomatic retinopathy. and the complications center-involved develop treatment anatomic diabetic one-third complications diabetic macular PANORAMA, to were of than the to develop injection, with is the rate of the severity their XX%, markedly these endpoints the is reversed on reduced leading intervention in based complications which diabetic more

study Protocol of Research addition is Network is Retinopathy as EYLEA Phase In PANORAMA study, retinopathy. study ongoing. This diabetic our conducting data the X its in known to from government-funded Clinical W own Diabetic

this in substantially visual interleukin-XX thus, with number over competitive we EYLEA. already EYLEA. dose Turning efficacy in a doses that product that interleukin-X, isn't higher our diseases. with of we provide allergic to the to longer-lasting achievable I'd EYLEA compared flexibility, view, investigating and are benefit, dosing different approved or worldwide. now in and to have landscape. gains are Nevertheless, might XXXX. million believe can the Dupixent, we doesn't aflibercept XX in that demonstrated that program our into near-term administered of entrants In and or substantially is the development there appear than any can It potential to and safety are pathway like any a that clinical antibody profile different near-term blocks turn diseases, provide additional has formulations multiple retinal efficacy safety advancing duration

its by require is Those of asthma patients unprecedented of treatment for with for Dupixent moderate-to-severe corticosteroids Dupixent with to phenotype the who their disease manage the in oral an newest approved disease. types in with adults Dupixent, uncontrolled With asthma: those and have and an demonstrated of profile. approved adolescents. for major Just FDA was eosinophilic a approved important asthma, weeks indication: biologic two couple ago, the second we

to XX% As of from increased critical eosinophilic with patients label, to by of placebo. XX% to FEVX, function XX% compared reduced we our pivotal to measure in by studies severe noted in asthma, asthma, XX% in lung exacerbations to placebo, and our up a XX% compared moderate-to-severe

for biological that will from eosinophilic is of launch oral asthma approved asthma as corticosteroid-dependent offers self-administration. Marion. way, The under phenotype, the In U.S. asthma addition, is patients you Dupixent only regardless hear only and in biological the the

Our regulatory by regulators. application is asthma under for review European currently

second in quarter XXXX. We of the decision expect a

patients In including lower of aged allergic discharge, inadequate rhinosinusitis we suffer of quarter Dupixent upper with and of X three in first this inflammatory ongoing late-stage in Detailed X with the now allergic disease the and control, in of Type struggle of internasal NSAID-exacerbated and first improved nasal in asthma, submission patient. to X separate currently inflammation to disease. efficacy interleukin-X ages co-morbid the to for more inflammatory and that and/or the terms atopic smell Dupixent are airway patients In of now, enrolling in rhinitis, chronic chronic and Phase the breathing. group corticosteroid in regulatory or clinical Dupixent indication the first trials current a patients polyposis. pivotal development these conference. intend disease. and make XXXX. are surgery, in showing between of is asthma, and study pain, planning are in systemic years, patients with six and for control trial significantly use are key The congestion five size, often, These demonstrated chronic X the the other X three-quarters inability inadequate. conditions, in can along from than nasal asthma polyps Type size and treat care, need with in Phase October, nasal reduced two a from Dupixent polyp with standard note, function with diseases: pre-specified presented the respiratory lung drivers polyp months nasal has results a results of same Patients Dupixent will that nasal nasal or severity, in oral the asthma, that to studies of significantly In polyps, years. Of difficulty We interleukin-XX dermatitis, Dupixent announced of which evidence providing a rhinosinusitis medical be this rhinosinusitis with to corticosteroids we atopic asthma, includes of XX safety nasal surgery. often of FDA also future

studies, from As with we condition patient such as diseases have allergic well allergic one often observed diseases. suffer – our other in

broadening of Dupixent's we indications. the for allergic regulatory dermatitis. are X years. Type Dupixent We the announced patients our the U.S. extending for prior sBLA adolescents of morning, younger XX to for that basis This Dupixent In atopic review, in positive X recently for and approval in a FDA age with it reported These committed the ages the moderate-to-severe between has patients accepted adolescent XX results and study submission data March to The in additional age groups Phase of were we with adolescents treat XX topical of atopic geographies, was ages biologic and into six and dermatitis, medicines X years as the to there whom inadvisable. systemic patients XXXX. currently is topical FDA-approved inadequately between target to XX are FDA the moderate-to-severe whose was ages patients Currently, XX, months We're XX conducting and years, in or the moderate-to-severe in controlled medically as with years. date for for treatment of studies five therapies decision no with younger dermatitis. also disease between atopic well dermatitis, of atopic

our initiated for adults study of dupilumab terms we Phase with in adolescents eosinophilic esophagitis. other and diseases, In X/X

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regulatory unmet not became PD-X cutaneous for trials switch Dupixent for atopic have kind treatment The as by the plan We but approved first the our initiate for progress, and one. immuno-oncology, monotherapy, CSCC, were exciting solid of an cemiplimab-rwlc, in be important the this the Medicines to the only squamous anti-IL-XX with year-end two of Agency dermatitis. One in first other the us where is high carcinoma. response end I to treatment tumor. now we ever treatment cancer. will There name which the or first Libtayo where the advanced cancer United are the are combination both Dupixent. the need decision X and European of a for application very asthma, half XXXX. Phase as very the the no highest with for antibody by would cell have antibody with States, in recently as PD-X be where studies continues the three currently EMA-approved made a focus to carcinoma, ever expected we advanced strides. have will and treatments for reported like in of anti-IL-XX Libtayo, FDA studying cell and in setting among cutaneous to any interleukin-XX combine by area of We Outside monotherapy, COPD well reviewed brand in September, being for of of field we this approved a At rate

an lung As Libtayo. we before, have for consider stated potential cancer non-small indication we cell being important

and the approximately Libtayo our as planned. cell data patients. chemotherapy indicated comparing Our review XXX our is call, on doubled Phase PD-LX have patients field, this quarterly of to non-small we XXX trial Based cancer to had in X evolving size in last patients enrolling program we emerging from of lung on our in as monotherapy high

with cell are with We first in Phase chemotherapy second-line antibody in cancer line. an and X also of conducting anti-CTLA-X studies in lung Libtayo non-small combination

in I with commercially conducted is available While CTLA-X these being CTLA-X clinical things own pleased antibody the report now are our to antibody, am that development.

bispecific to is platform, our now Turning program here leading owned antibody. fully CDXXxCDX the antibody our

American or at month the of data ASH, Society Next in the presenting malignancies. of B-cell be will Meeting Annual additional Hematology we

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starting of entered two bio This of immuno-oncology, technologies that into other bluebird in into in We CAR-T on the announced advancement a entirely try third bispecifics develop, be and field. to with make new the a have significant discover, new Continuing also the the first to will we the commercialize a example working represents class collaboration and cell with of synergistic therapies in progressing of an we collaboration cancer. half together clinic XXXX. quarter, great companies to for theme

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have we for full high that alphaX a know, GFR pain to of you most antibody an of clinical end, development, recently neurotrophic need. To unmet into pain factor molecule another the represents area receptor. As advanced human

cardiovascular Our are programs moving clinical metabolism ahead. in

date where for review, in Breakthrough reduce familial of with FDA homozygous familial XXXX. potential And antibody, cardiovascular and apheresis. for Praluent to a received X for heterozygous April We familial addition an major in patients development We the ANGPTLX sBLA clinical and homozygous hypercholesterolemia in familial studies pediatric Phase Orphan events as treatment of adverse action is designations. approval study recently are with Praluent accepted studies a hypercholesterolemia. treatment to XX, undergoing hypercholesterolemia, heterozygous received for Evinacumab, target finally, homozygous hypercholesterolemia, the has adults Praluent our regulatory it's the Phase enrolling X with of in in

of in Phase hypercholesterolemia, a also patients familial and X Phase another X hypertriglyceridemia. are severe in enrolling heterozygous refractory study We and hypercholesterolemia in study evinacumab

clinical the data In we in program. be at programs also terms our antibody Annual presenting additional from of our wholly-owned CX ASH December, will other Meeting,

the Phase molecule We study expect to initiate in XXXX. of a hemoglobinuria subcutaneous-administered X the with paroxysmal first nocturnal patients half PNH in of or

a Another potentially pivotal exciting rare ossificans molecule in X in Activin-A our our fibrodysplasia study pipeline a called disease antibody, progressiva. ongoing we currently where have is Phase

Finally, within the milestone any, achieved. expects call now human centers Center I that, a to of I ever few, mark would our Marion. Genetics like to months, the hit With next like would have sequence, just over the to Regeneron three XXX,XXX to if highlight, turn

Marion McCourt

EYLEA as markets. George, aging brand markets. the of on diabetes. would overall you, global XX% start billion, branded increase of holds by and an quarter the with net Thank currently increase. DDC like net sales preference EYLEA billion, population, U.S. year-over-year overall approved This and the launched indications where the AMD year-over-year. U.S. In well EYLEA, interest, physician to select in of $X.XX increase driven market and awareness DME, both effort we net in prevalence sales, $X.XX third about a consumers I as recently everyone. raise good and X% educate campaign were the morning, and to and sales of EYLEA anti-VEGF in was increase growth were Based an for the wet XX% pilot in

retinal retinopathy AMD, and EYLEA diabetic occlusion, we diabetic in for opportunity potential indications of DME, Beyond vein the with see DME, approved retinopathy. wet

data regulatory next expect year. in positive George, U.S. in this heard a just we in the you of reported decision indication recently May As from and

to untapped drive plan potential this to Following approval, campaign indication. in focused adoption large this initiate we a

announced for FDA-approved every modified only anti-VEGF a AMD a August, specifically dosing year approved wet label. drug that moment effective our EYLEA. schedule This treatment. EYLEA makes after XX-week we I'd spend in its with Additionally, AMD X-, an referenced the EYLEA dosing for and the in XX-week one for prefilled to X- wet sBLA like for of for discussing syringe

We we the make Complete a be a to the We previously evaluating received Response Letter single the which remain that XXXX. the As plan in request, satisfy we of usability study first in from included announced, a approximately XX of will confident patients. a to completion half FDA. agency's submission regulatory injection able

have on prefilled for an Our launch. continue for launch not changed, timelines we syringe XXXX and the expected to be track

Turning now to Dupixent, including global by U.S. reported XXXX, our $XXX were million $XXX net sales of quarter the in third in million, collaborator as Sanofi,

patients. start dermatitis. demand treated moderate-to-severe important television branded an dermatitis with with for launched prescriptions and with potential atopic in vast TRx well. the is focus. Prescriber ongoing U.S. Dupixent dermatitis a a this breadth treatment Dupixent Let over is now Despite have majority the and about approximately Dupixent me as patients XX% sequentially. not recently Underlying remains encouraged depth the strength in atopic over XX,XXX with area U.S., having or XX,XXX we campaign new providers national the Dupixent. with this Outside launch, to atopic Educating in of up early launch strong Dupixent the by end, progressing To prescribed of patients Dupixent continues of healthcare to improve total quarter-over-quarter results. been are

number extended with action adolescent that been an age. in population. Dupixent announced, dermatitis of the in adult of atopic sBLA will and to by half years about XX as that the be adolescents date to allow as FDA Dupixent is XXXX. filed patients with young patients the We If March of approved, for dermatitis George estimate of Priority benefits atopic the granted As has Review this the

also autoinjector a we have addition, an In application for for XXX-milligram submitted Dupixent.

most which to is Dupixent. approved now asthma, recently indication Turning for the

you and that that from been adult for has despite a is estimate feedback launch for believe we about underway detailed have these XXX,XXX biologic in uncontrolled it only the be provide differentiated the metrics. with treatment now, As a with The too symptoms physicians We've only are with been treatment patients suitable couple in highly a XXX,XXX any is heard launch from treated U.S. to George, of early market the may are patients approximately XX% persistent so standard-of-care moderate-to-severe Dupixent is of asthma to weeks adolescent of biologic therapy. positive. biologic. for asthma. a We there Currently, therapy and

preferred ahead. asthma. the cutaneous and corticosteroid-dependent of physicians XX, eligible squamous is estimate to are in with One CSCC, asthma of XX% of patients key approximately control avoid Early are allergists the persistent Dupixent patients. the oral cell approved at We're asthma limit treating We surgery with is the already these familiar are profile use non-steroid with educating for efforts are look allergists option a Dupixent goal updates We working to launch biologic. I'd the providing XX% Libtayo, treating for and treatment for now positive. radiation. about awareness to candidates been patients underway, for approximate oral on who engage indicated or with forward uncontrolled these the Dupixent's With the considerations represents disease. creating the XXX,XXX that patients the antibody. are patients locally with doctors curative a mind, has making months not PD-X the On advanced to and the of September population we actively Libtayo for atopic XXX,XXX Dupixent moderate-to-severe treatment for steroids curative or in metastatic of carcinoma, differentiated the to of biologic well pulmonologists. pulmonologists further with patients to launch turn with to and asthma reception optimistic asthma. our FDA like dermatitis, also that Many first-line the both to or in

engaging to in the of Regeneron a CSCC oncology in Libtayo Medicines XXXX. major sales MO establishing (XX:XX), the medical centers surgeons of step European of make major player first skin targeting force the in the of quickly for by FDA-approval, standard by half expect Agency specializing cancers. the goal launch decision first and a oncologists milestone in to Upon is care continue as Libtayo a space. our We the immuno-oncology and The mobilized

from later XX, community an the rating, in was responsible for $XX providing been included reimbursement so an in with each has in the need rise Network, therapy all estimated broad CSCC. Libtayo expected Sanofi U.S. for and patients the coverage number XX% positive. can of for NCCN XX% in were cancers that deaths update Cancer the Libtayo a million, cases CSCC. of far, X,XXX medical forward So with to access the We is successful the a National the by quickly. net look a approximately global diagnosed skin the XXXX. X,XXX XA in of sales updated accounts Comprehensive only time. to the NCCN, Guidelines rating systemic year at third feedback received On October with evidence compared been in representing to third to get quarter cancer on currently annually. It Praluent, to From Switching quarter establishing payor in skin of further launch is standpoint, the access common a treatment CSCC most recorded U.S., form increase and we've Recall newly

from and have decisions the OUTCOMES of half EU, in second in regulatory the the the We study submitted data and XXXX. anticipate U.S. cardiovascular agencies to

market [Preferred] since increase in payor guidelines (sic) XX% and prescriptions engagement PCSKX updated will addition grown These of to the steadily. net our Based Formulary. third expecting use shortly. exclusive the guidelines the number up on Commercial continuing quarter remain We the sales, ESI share greater the on to in the U.S. updated significantly the lipid-lowering in that with increased (XX:XX), are U.S. facilitate be [ph] We're support of access continuing to and the also (XX:XX) formulary Express National Scripts the inhibitor has the PCSKX inhibitor may class. treatment

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

I'll has class, to dispensed share the TRx. XX% of turn subcutaneous over call NBRx and share IL-X now Bob. Kevzara the Within now of XX%

Robert E. Landry

third and operational results good the morning, and strong report Marion, both for line solid to pleased everyone. XXXX. top quarter of performance Thanks, I'm

by guidance encouraged leverage in portfolio, across of year on reflected and reduction items. Dupixent our are sales growth, We EYLEA tax and progress and operating our expense full our improvements as XXXX the line

and earned diluted driven in grew of income a by revenue of EYLEA, represent billion net third we These income, Bayer Sanofi performance results year-over-year in the other to of United for XXXX, and non-GAAP million. the $X.XX billion per compared $XXX decreased to normal increases yet grew targeted of EYLEA the X% $XXX XXXX. remained distributor inventory to within net XX% revenue third as $X.XX the collaborations, and of one- second revenue. and on U.S. growth within our in two-week net quarter diluted EYLEA in range. year-over-year EPS States million product both For increase XX% quarter XX% U.S. respectively. sales the share to compared our the quarter quarter non-GAAP $X.XX XXXX, Total to

the second that the physician increased our offered commencing week practices of regardless existing we EYLEA earnings last discount of call, June, we in in disclosed to As volume.

XXXX, of third of was compared As the U.S. in recording third started quarter we and shipping X, slight first a the to of Effective result, a net Libtayo. sales EYLEA's degradation and XXXX in gross-to-net quarter half there October percentage XXXX of XXXX. both

share the September for Sanofi U.S., reminder, collaborator favorably net lead million, quarter a As realized September record compared U.S. three growth XX, to the commercial we to by The Ex the recorded XXXX. the of co-promote Libtayo third Sanofi derived has was in The the U.S., U.S. product was in third of EYLEA and for $XXX product of XXXX XX, year-over-year to $XXX were XXXX. of XXXX, year-over-year compares revenue ended collaboration revenue months to for months of Total $XXX million three quarter XX% three grew million from $XXX a million operational representing outside collaboration basis. factors. increase revenue months year-over-year XXXX, net the a million for the from will our which sales. ended $XXX $XXX three Total by was the Libtayo for the exercised increase $XXX XX% Bayer Bayer option sales on and are EYLEA its reported represents for driven XX% XX, the million, the profits sales year-over-year million ended which XX%, September

commercialization financial products of from loss a of million XXXX, with in of the had of new Agreement primarily necessary compares The by to of indications the with loss XXXX quarter $XX higher net First, of and of reimbursement products. a associated three increased quarter in its in versus containment for the quarter. and with Despite we in connection factors XXXX, to Praluent, increase Sanofi losses and and Sanofi Discovery with and decrease XXXX. favorably Antibody in commercialized an which revenue and $XX third XXXX Dupixent million License third, these expenses no investment the share our Sanofi a performing launch in Dupixent million under offset expenses. Collaboration we of the of quarter in Alliance of commercialization increased million a for best of Kevzara; sales Praluent, expiration higher realized quarter. in was third revenue the cost of compared with In of quarter in R&D markets, global $XX attributed we this associated from a million Development commercialization reimbursement the incurring Sanofi, the third Agreement, investment immuno-oncology; share the connection and the revenue in which Antibody standpoint, revenue $XX second $XX our recorded Offsetting recognized continued second, third is the of Dupixent, Preclinical higher loss quarter of to new loss Praluent partly commercialization XXXX lower

new Alliance's few While expenses incur we financial XXXX, variable launch quarter to for the fourth we as higher for operating are continue the commercialization of the of quarter in of experienced a remain in third connection we expect expecting to next of antibodies. Compared to leverage markets. in Alliance in XXXX, third the indications new loss we the with quarters improved quarter XXXX, these results the

deferred of recognition was I development a the XXXX. higher of Before of of versus to our in Teva million our $XX Advanced XXXX increase to revenues the the turning Other million revenue an briefly comment recognition Mitsubishi Ebola in and $XX of Mitsubishi on to third BARDA, develop, virus milestones of $XXX amounts of treatment quarter or third revenue primarily and and test, Tanabe, related XXXX, other the third a was quarter Teva also the to Development and agreement the Biomedical from In from revenue recognition manufacture of revenue. quarter This infection. with XXXX. for including quarter driven by of therapy third achieved amount to increased $XX expenses, from Research Authority, million antibody portion related million and Tanabe, want respectively, the other the

section result in quarter you million expense as in summary R&D find As a head third partly non-GAAP was a by Dupixent quarter cost. and Libtayo The revenue offset other the for the of the decrease cost of facility-related increase costs, an XXXX. R&D, increase higher count can of $XXX XX-Q. clinical a were development components compared R&D in and in the of XXXX of to million third the the MD&A expenses $XXX of reminder, Non-GAAP for

expense, R&D XX, XXXX, months compared for was September the Our calculated non-GAAP our R&D $XXX expense $XXX XXXX. million the ended from three which total for three million September to XX, less R&D collaborators, reimbursements non-GAAP the as ended unreimbursed months is

attributable of and this immuno-oncology Sanofi The the increase $XX is higher with by Preclinical earlier, Discovery of million highlighted R&D increases associated driven Agreement clinical were of of wholly at of Antibody programs. the and our growing costs number owned share As expiration activities the XXXX. the to end remaining

R&D unreimbursed non-GAAP includes Our calculate press release to the required information expense.

adolescent of the asthma. tightening year million to XXXX. and previous were the $X.XXX unreimbursed and launch Dupixent compared XXXX in for three to was R&D guidance Non-GAAP XXXX $XXX and not-for-profit ended lowering expense our million the expenses our full contributions in XXXX billion to months of primarily higher are The Libtayo SG&A billion for $XXX from increase billion. range the quarter patient $X.XX of third expenses of assistance third to We organizations independent to September quarter for XX, an as expense due to SG&A billion in $X.XX in higher non-GAAP adult $X.XX be guidance and for

and SG&A to is lowering item guidance, patient expect Regeneron XXXX. quarter $X.XX year revised higher spend tightening Based quarter XXXX fourth $X.XX be in a for we of billion SG&A to $X.XX on collaboration spend billion Sanofi $X.XX reimbursement and by are the higher third billion billion. from this driven full million support expenses, We level including a This non-GAAP revenue, to Sanofi including expenses, the of programs. our commercialization-related line $XXX DTC found DTC; EYLEA Dupixent and expenses, within XXXX. was expense of

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

at collaboration September goods cost XXXX, three the of validation due outside compared manufacturing commercial of absorption increases months facility. These U.S. costs as due at XX, partially to same increased better non-GAAP Cost ended to as by period Limerick, antibodies, of our manufacturing contract Sanofi of EYLEA BARDA. and principally well the with collaboration the to manufacturing cost XXXX, recognition with declined and Limerick associated as the sales sold our For in volumes Ireland higher facility. our were costs lower offset both agreement

taxes. to now Turning

effective rate Our third planning with primarily associated compared the third enactment of Act, the of the as the tax this quarter tax to driven as Jobs one-time benefits quarter with XXXX, and Cuts X.X% tax in for XXXX XX.X% Act. Tax connection was by well of in

U.S. benefit earned activities, than research from lower Our Federal for tax tax income rate continues tax jurisdictions and compensation, foreign the with to the rates stock-based credit in

the benefit net provisional for XX, income included U. the The which was related remeasurement third December tax Tax recorded U.S. of was also deferred as to company's the of million a to GAAP adjustment XXXX, Act, an amount of of tax Reform quarter $XX.X assets. that XXXX the S.

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

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

flow the XXXX. We free as XXXX an expenditures. activities of September cash third cash and and cash to and nine cash from the of securities next marketable quarter capital operating Regeneron net calculate ended flow generated balance $X.X XX, less free $X.X provided billion sheet. excess ended of of cash by billion, the flow Turning months with

for XX, months ended the XX, three million, total, Our ended $XXX capital in XXXX, September the expenditures nine XXXX. were September $XXX months million for

and $XXX million prior million. of full $XXX million XXXX We million are year our capital lowering guidance to to from $XXX expenditure to range tightening our $XXX

with entered BD for into bio. front, also XXX,XXX we $XXX collaboration with connection shares common million. purchase the mentioned, George the the we bluebird to as of a of In On collaboration agreement, execution agreed stock bluebird

credited agreement, purchased, $XX part value be million, market in excess the As amount the of shares collaboration our research. of for obligation funding paid the will fair the of against

to hand the also Before announcement September in wanted I the York highlight capital an regarding in with agreement Regeneron to support back new economic a New call region. of State Q&A, I commence exciting to Manisha made the development to

York would jobs $XXX expansion New X,XXX expand in the next development in the that, seven will Regeneron Manisha. has State. from create turn committed million New years, back and to full-time With supported economic to Over I call like invest by new million York State. to facilities This $XXX be incentives to

Manisha A. Narasimhan

that the John, for call Q&A. remarks. our concludes like Bob. you, open prepared to Thank now We'd

Operator

session. you. Barclays. question the And Thank now We'll begin first is from our from question-and-answer Geoff Meacham

Unknown Speaker

Can the atopic for (XX:XX) asthma access? for patients launch Dupixent? for you're recently talk how seeing taking you able Geoff. in Hi. on This Harrison to question. trends been get this payor Have Thanks Greg is compared with And with us is the dermatitis? through access the

Marion McCourt

But progress Dupixent only that our reflects coverage. the Greg launch. pleased you just uptake very with comment, (XX:XX), So, payors. Then, performance. dialogue asthma remind the market asthma initial And, we certainly certainly, the course, with the and adequate launch it's payor atopic I of the a indication, alluded steady for with with I'll majority this new report and can week is see dermatitis that to that Dupixent of days, with in But seeing we asthma. as everyone in early with for are coverage. we're third the market Certainly, in making

Manisha A. Narasimhan

next Operator, please? question

Operator

UBS. Carter from Our Gould next from question is

Carter Gould

the there. front for guys guess, mitigate Thanks morning. I wanted can that Len, just yeah, anything the on all out House commentary thoughts the question. either of HHS, you on White to sort around that proposals B messaging, Hey, do on latest get to to it guys. the Good given that your coming taking Part of – and I'll either

Leonard S. Schleifer

the reference actually open do mark in which a fraction Carter. given to know they a these something Thanks covers about get policy a is tough large drug that's become the to starting at be question, serious pricing, lot wide, a or will pre-election. to I country administration Obviously, I think this not with the announcements of think in question pricing. year big, able of trying pricing with whether – demonstration for big XXXX it's international do were your going Yeah. Hi. to what's But time.

Manisha A. Narasimhan

question, Next please.

Operator

is Cory Our from Kasimov JPMorgan. next question from

Cory W. Kasimov

biologic you to-date. you're severe how when Hey. for in looking I'm Good low question. population the for curious considering moderate eosinophilic the asthmatics the you referred penetration taking to Thank morning, asthma Dupixent for my guys. at opportunity market

be historic So, penetrate the you'll focused dynamics, of in I the much those the moderate so launch be we should or of year on do or to guess, patients really given able product's Thanks. you first severe? think

Leonard S. Schleifer

for question when a et low doctor's is Marion? – I'm cetera. cetera, or an And day, you exceedingly after et comment. market the product. going a infusion has make to office to half it let just I have to there hang be get moderate around to brief The the is in population for to see one Marion that answer yet self-administered expected penetration

Marion McCourt

Yes.

anecdotally, and of patients getting it's first. tougher that positive. in allergists, will the use we're I'd product, this very reports that on not add in case, physicians, pulmonologists asthma unusual their a and that, some Dupixent, been share for it's have case, to So, that I'll this very, often

severe, think EOs to of broad regardless continuum quality life, that most in have I patients, over we'll of of reduction XXX, only only definitely, clinical of and not lung EOs. of OCS evolve exacerbations, in our than efficacy, phenotype then really not label; we function, but and OCS-dependent I think patients will Dupixent profile in moderate-to-severe also the greater with category course, that the time, But why, moderate overall compelling And over achieved its success asthma, but market reasons experience. they're or the also that patients. relates So,

have just add we're As ability the educate in and are of is is they product, indication. launching factor we're biologic can is not offer both in Len to that a to to, launching that start a office to new course, important the really only this always the new the is with element help important hearing physicians so a when want use. that, broader patient other another train them. we're that asthma self-administration and mentioned, I'd we a Dupixent, then But item And at-home

So, allergists an who shown we already already established have and experience Dupixent, safety profile. had with

we're early So, I very, very reports forward really you days. It is to the giving about future. launch. in look excited the

George Damis Yancopoulos

its have that make patients, safety up, in that brought lung can patients' can And of on has is reductions for substantial penetrating is really this with they be for there's that moderate first into something lot a have impact lung emphasize you're together profile, about may the that, talking biological really can to have to really profile lives. the a think want is a which clinically just And essentially When real lives. rationale that a Marion moderate function, I population. impact in George. biological patients' a I that clinical the about functions. pretty still potential particularly meaningful difference on And their

Manisha A. Narasimhan

question, next please. John,

Operator

question Piper next Chris Our Raymond Jaffray. is from from

Christopher J. Raymond

thanks. Hey,

opportunity from sort of improve you're potentially obviously work, doing not allergy, desensitizing question maybe strategy kids I about a in – could lot Can that market, that talked of objectives where there's maybe other little But do think take what that to that a even? Aimmune. Aimmune's you've What experience bigger on in about food for study period. in of you the or work of being success in initial peanut bit penetrating think does frame terms allergy. like just this maybe just market? Just talk a the And allergy look Thanks. the Dupixent you able on this the peanut you with us, up-dosing trial? during detail is

Leonard S. Schleifer

to of immunoglobulin the I surface other fundamental as in cells for interacts That's clusters is it of science Just the allergic think you everybody E with histamine, a have resulting allergen, and and basophils. once surface degranulation, known allergy. it kind mediators. have reason the bound second, allergies mast has that is to into you release that to immunoglobulin understand that a on of the of get And these of cells, basis the certain

factors. in are system to make of For of make and goal When fundamentally E of and know, therapy is the George, instead Ellen. interleukin-X good in reprogram switch desensitization IgE don't interleukin-XX those immunoglobulin therapy, that system you the immunoglobulin you try who the the as antibody immune immune as whole G, or

whether are don't a have to IgE. of impacting cells and trying you IL-XX the So really IgG actually you when – IL-X blockade fundamental or response blockade drivers. are that in natural the go way are and the involved desensitization,

studies, setting want results of reprogram giving difficult do of pretty animal white. any should Dupixent black has historically you that the been the much in to in So, achieve. And or desensitization, very exactly are drive that and kind

Dupixent is goal almost do. to approach, making that peanut, start exactly of That be So, desensitization, is the believe it whether and grass, whole be in to we with can stop any setting any whether it IgG. making what IgE

So, the GI to the limit during take the that side doses desensitization, the faster of peanut effects of patients treatment. what or on success effects, whole have ability decrease tolerate their allergy-mediated that we ability stay who to mostly higher number side study is hope in

be beginning. of the has available just is this should will indicators it every in If is thus, form reprogram Dupixent modality. And should from driving by allergy. doing, think IgE, that is it these the from to preventing more peanut, essentially body away doing here, whatever a body the be of what which All and signal and works making be desensitization exactly IgG applicable it it we the

Manisha A. Narasimhan

question, next please? Operator,

Operator

from Our Leerink. Porges next is question from Geoffrey

Geoffrey C. Porges

question. taking Thank the much very for you

in going price be involved, sort less the expectations step are have you And there'll whether but to same adoption as that population, of just or you this be is address Just unrestricted mentioned then largely Thanks. Could at and rebates the think and launch. And follow-up just comment be access? to price to edits faster you're managed indication you more back the able whether expect the would slower do be your you by on the what there? bit. Dupixent and you have you you payors, to on or AD or to a adolescent little question Could actively think to going there? asthma of

Leonard S. Schleifer

you we you to have a Geoff, answers, before might by. Marion invite antiviral We come give we there. can antibody

Geoffrey C. Porges

(XX:XX) appreciate that. I'd

Marion McCourt

coupled and forward to what would the increasing. We I bit reason, a is families. little with and with So, faster the a and is it well in little the their Dupixent. should I reasons. known, but adolescence, patients with want be And to uptake that physicians disease, prescribing the and product Dupixent saw think for in of have faster group that depth realistically, that we might two Geoff, similar, for is becoming conservative these why get truly with dermatitis, the now comments are uptake And that look your that anticipate it's be indication helping fact experience to and adult goes for great on as moderate-to-severe alarming first patients be word we of agony we important believe adolescents, there's of think addressing patients it's them this mentioned, that this an disease potentially I very excitement suffering. bit and this who similar enthusiasm out market this group for the well, that saying the is reason for indication, for atopic a the very much both quickly, in than in we for

in related are the market. of been think more specificity time we more Your going so profile very week payor launch, rather There's asthma I second our the payor back on things early and to third great as is well. uptake, clinical give it's detail and have But question come days. of to This receptivity product. I'd

Geoffrey C. Porges

Thanks Great. much. very

Leonard S. Schleifer

to spurts to of pediatric wanted add this, a lots or they're absorbed systemic lathering (XX:XX) during next big adolescents deal. is from steroids, side (XX:XX) whether growth the with bursts treatment that their just it is setting of of I in on

to early So, I move why reason another think adoption. that's want to might doctors

Manisha A. Narasimhan

please? question Next

Operator

BMO from question Matthew Luchini Capital. next Our from is

Matthew Luchini

Hi, great. Thanks taking for the question.

we've Thank the your us give as on the had patient if for dermatitis, view update your Just atopic receiving DTC was perhaps you. for drug an earlier ongoing little wondering That's persistence could well was campaign on something a mentioned you that's as or now view currently I Dupixent, rates. the on in mix latest current or the that I don't remarks. think while. refill

Marion McCourt

Sure.

me let persistence refill So, first. and rates take

So the in XX-month the being commented on we've point the continues. approximately that at past persistency XX%

strong persistency important the first see is script with and still factor an over we we on Dupixent. at Similarly, So, XX%. – that see refill

are Dupixent are to stay they these atopic patients because So, on indicators better. for want that therapy when on go dermatitis, their lives therapy

I believe, on the the DTC, bit of little types the a is part mentioned you piece question, second was also, The of and patients.

about to severe, really patients order really responsibility awareness I Dupixent for some part because We've similar of all, previously and broadcast months Dupixent therapies were was absolutely TV helping we of So, them in start at clearly our with disease up the do right ideal with we're potentially most And a We're for but for national been we was now, was campaign, given the thought patients. only it perceived, that to for this thought that not August only – by disease things. and before, still campaign. mode campaign was an branded since it's now this campaign. severe would that we had who not to getting timeframe. made the thought recall, their branded TV But in unusual physicians the comment to It product not as with moderate also penetration on-air patients.

we're months far So, signs see in. we are encouraging. so The several

Manisha A. Narasimhan

please? question, Next

Operator

Flynn Our Goldman next question from is Sachs. Terence from

Terence Flynn

heading track you maybe taking It for are here. double-digit unlikely but talk give like year year. on and next the Know the you about branded guidance EYLEA XXXX, looks just Thanks question. could into to takes growth another puts for of for we're Hi.

Maybe to to if be wondering So, that, here dose formulation should decision? XXXX. EYLEA. market? this into required have then you Thanks. that that mentioned you think that actually what we of continue drove And what heading higher bring just this And learned would

Leonard S. Schleifer

can the higher So we George can dose, and the comment about maybe take market. then

George Damis Yancopoulos

a competition, of been impressed has with able profile terms point that in with fundamentally up guess much one of of come vision the treatment. in that seemingly, so is Well, we that I fact the to and a higher benefit, effects has dose, with terms EYLEA really different stood on no up, remain or the duration

time, higher the And now, was is the the of standard take EYLEA so, while, that improve it either could field, actually especially to a whether see see of dose and/or gold the the this we EYLEA duration we in on because if the we've and thought labs in just giving extend a working benefit been we what past think, can for interval.

the to a in this poised, on putting been and we've year. so we're working while, And going it for clinic we're be this

Leonard S. Schleifer

Next year, XXXX.

George Damis Yancopoulos

Yeah. XXXX. Sorry.

Leonard S. Schleifer

Right.

– So and then...

George Damis Yancopoulos

XXXX. I'm operating in already

Leonard S. Schleifer

increase underlying somewhere market market it what XX% are times continuing to low-double-digit terms I you, we'll forgotten retina about certainly plays to that up all have lower can the the and up as a mid in XX%. most a nothing even where And anything disruptive. to growth the we based come the XX% to can drug do smartest over math (XX:XX), and the they In that's echo of out. AMD see seen specialists in by letting and diabetes have they change the the haven't RTH says, than on how see some actually they physicians. lot sponsor, there for fit at competition, time. growth, out multiply that the number But Obviously, there, that demographics in or increase guys have we George we not do seem with grow the will – me We seems demographics all. high what be in touted drug Those seen of the haven't to

really So, it me a has to seems good that profile. EYLEA

remarkable. the In we think, was, addition, quite studies what retinopathy diabetic in saw we

a It's reeducation I frequent of diabetic prevented watch was leading take to there big startling and of we blindness complications. leading for that not to patients disease with think and them, placebo, reduced, some retinopathy going one we progression develop untreated adults. when physicians, how the the and only that is large that's in causes it this out but was given just advance. about asymptomatic actually be still diabetic prevent think can it that, retinopathy, And retinopathy. of diabetic dramatically a-third, fraction both diabetes of people deal. fundamental the diabetic year, the think but a that's eye vision-threatening Remember many, And of a and improve

Manisha A. Narasimhan

for last time have we please. question, one Operator,

Operator

And question from Huang Ying is last Bank our America. from of

Ying Huang

I the questions. than less of about placebo at fasinumab And at X saw have recently one In top the we showed NGF. taking incidence for RPOA. X%. for saw arthropathy ACR then released line, Thanks adjudicated Hi. Pfizer the you the X.X% of Phase adjusted rate –

that next, more you therapy safety (XX:XX) for kind think collaboration physicians, Phase safety bit then long-term little whether exactly Thank and wondering X kind the you color could in on your acceptable give for the with if target focusing Just you're a the and of style us gating what's what bluebird, what of of of on. and you. trial? this is the And treating factor kind the FDA for

Leonard S. Schleifer

Ying. Thanks,

really for the on think dose – any when very in me our And been basically his side far, you good remarks, George has right. efficacy try results mitigating but that – that that and and think but to important. can know George add important study is all have long super got Let a any able fasinumab we And response right really, drug the still then is comparisons what's really get efficacy that dosing have effects. we're becomes that – really getting the perhaps, curve the and drug that And bluebird dose course, I steep that best-in-class said and we least so safety. that just development approach to that say at I as of results dose program, to prepared produce very thus far or fasinumab. maybe the in on comment we hopeful comment But dose to notwithstanding,

it's that to certainly other more I or the would acceptable. ours, doses be you've I program, But you of high a there's arthropathies, some not – probably that probably And that safety, In terms which more be replacements. I would just adjudicated treatment of whether an the or don't think be think seen development be see to joint evidence, joint will in acceptable not There's going this would believe level. also question less in of replacements.

efficacy. is very (XX:XX:XX), demonstrated continue these carefully has program met development low we've to Our where and at monitored independent recently, the which VSMB us advised an doses, by

might we So, first that talk we've bluebird. program the important there there's here about can right got Being this much George in not right. in not be others. dose being error because may nearly be as hope as as as for room

George Damis Yancopoulos

add to to that. just Yeah,

at at we dose important know, long-term the going to is mean, whether with be and see NGF. that. this a very the most concern, seem certainly said, is total replacements you against with, arthropathies, to to see Len we the with study to since benefit continuing data I what joint we're will And have that we'll numbers mitigated are safety gets point, adverse events be our competitors' the important the to believe have compared as around least As program our

In be cells and new targets be is exacting receptor-related technologies these made terms bring into of bluebird, therapeutic their their be I antigen develop into into to or put can we and think the therapies. What that they we they've Clearly, whether developed new us, is receptors and for reagents, chimeric put that can approach. antibodies collaboration. very abilities new by bring table target T-cell reagents demonstrated and targets and to they've to a via this CAR-T bluebird their used

forward between with new them and ability And together about our to antigen excited future patients. synergistic take putting there. be complementary new able two very we're So, targets very this ability and capabilities, their deliver real companies bring we these the with a think receptors we're those to together is to chimeric hoping and to make collaboration ways change to to

Ying Huang

Thank you.

Manisha A. Narasimhan

get follow-up I George. schedule able concludes all call but prepared you, a send today. call to Operator, e-mail we know will and with an please you. that – your Thank questions, to me our weren't our we

Operator

disconnect. and ladies conference. for you, you today's participating now you gentlemen. and Thank may This Thank concludes

Regeneron Pharmaceuticals (REGN) 6 Nov 182018 Q3 Earnings call transcript