REGN - Earnings call transcript Q4 2017 | Regeneron Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to the Regeneron Pharmaceuticals Q4 2017 Earnings Conference Call. My name is Jason, and I will be your operator. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Also, please note this conference is being recorded. the to turn Narasimhan. now will call Manisha over I

You may begin.

Manisha Narasimhan

of Good Jason. XXXX to archive XX be days. morning, Events Regeneron website you, on Conference webcast our available Pharmaceuticals' An Year welcome for Full and Thank under will and Fourth Call. this Quarter

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

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

Leonard S. Schleifer

you, on Regeneron Manisha, Both and strong XXXX an drugs: joined Thank treatment Kevzara, of webcast important regulatory clinical, and good under the for progress results. in two these arthritis. been IL-XX today. us the IL-X, countries. a and call We new approved Dupixent, with treatment and has IL-X for was important of for of commercial regulatory dermatitis; to who way approval rheumatoid antibody have for and received year significant to severe and in morning receptor financial drugs U.S., fronts the an everyone launches Europe on the and with solid moderate inhibitor atopic Japan, several

candidates in product development advance product continues new to productive. clinical four XX clinic year. the six We engine into currently expect innovation Our and be this have to to candidates

well and confidence are us we commercial sustainable, give long-term positioned Our for growth. progress pipeline that regulatory

pipelines across with are for of cemiplimab allergic each the multiple truly product molecule a two represent and cancer, within our single for dupilumab diseases product. potential a Importantly, candidates, diseases and opportunities for significant

EYLEA growth to diseases six I which price since to market been despite has has EYLEA to Much deliver the U.S. on driven launch, year-over-year now growth. trends the no trends U.S. in increase the outside prevalence tend the address EYLEA, the recent continued would like be diabetic with eye trends to recent EYLEA, increase the of undertreated, diabetes. continue year-over-year U.S. address, the the and and of to over coming as demographic the for and XX% United our the demographic sales thoughts it in developments. favor some XX% expected continue grew in These net years to an States issue in impressive an was in now in competitive as for and an plan underdiagnosed in the growth. are well Turning we of opportunities demographic an years, population, opportunity overall by aging to providing that continued

receive EYLEA. EYLEA agent has approximately DME been eye Patients in patients optimal data, of efficacy of are edema, growth and several majority anti-VEGF representing the DME. they are in even currently X% EYLEA the to leak sales diseases, upon to not proven Vascular over indication loss, in leads The performed vision risk of studies undertreated, by therapy. XX% shown be independent States is treatment known currently only groups. eye with they net a total which EYLEA diabetic diabetic has between studies diabetic been and therapy, is major United come important an receiving those Based and in approved. underdiagnosed from survey our swelling of to as of It disease diseased what because vision, diagnosed patients on anti-VEGF DME losing be including or for years when where in Focusing an with vessels with that XX% superior physician the treated, retinal macular and eye. at opportunity laser with estimated are may diabetes blood multiple for is

study million resulted those assessed, retinopathy investigating X patients gains who in attractive about is opportunity. diabetic diagnosed proliferative comparative Avastin, vision retinopathy had Of without Diabetic diabetic Lucentis data potential retinopathy macular diabetic published States line resulted compared superior visual unmet without year. the vision patients EYLEA data the and currently edema, loss. in outcomes the are indication In retinopathy, United retinopathy greatest endpoint either proliferative and X, our diabetic treatment. reminder, Phase patients non-proliferative in in particularly people in XX/XX. treated have high laser it have severe in are diabetic with EYLEA with we one diabetic to anticipate compared X.X diabetic are Protocol and at edema. year, followed of profound of at have As need with diabetic Phase than an of The treatment by And a the first Lancet, in later another the worse regulatory primary retinopathy. patients important About majority We EYLEA the acuity The to million EYLEA from in both being study half CLARITY for or top laser macular pan-retinal retinopathy greater submission these, this therapy. proliferative visual effectiveness who X when significantly are these risk photocoagulation in end the a T or NIH-sponsored is in with demonstrated of from was year the

conducting study diabetic DRCR.net of the EYLEA an the indication. also independent in addition, is Phase retinopathy X In

as and dosing. safety, provides physicians as flexible In for dosing other important those have that as well efficacy well monthly benefit established physicians regimen patients this flexibility aspect addition dosing to approved longer who patients is dosing includes another may for is to and month important EYLEA monthly from have between interval doses. a frequent every and well as for patients and flexibility for more to having the

wet In and AMD addition, decision dosing an for August. expect have submitted in an we sBLA three-month in FDA every

could dosed studies, X Phase patients our in reminder, be XX% of XX weeks. we demonstrated a about that every As

We preclinical also on research and approaches. continue extended therapy to advance gene release our

competitors emerging maintain are are potential We our EYLEA well to with continuing of we focused Like you, the aware position in for on leadership retinal space. EYLEA.

in has very We The well will XXXX. been on long-term latter of as even potential early since the execute debate with includes in concern the long-term studies. eye with gains. in about launch. if million initially bar new competitor a approved, demonstrating the There safety diseases, can market, AMD States has interval both approval vision entrants whether X expanding about indication. the continue be has additional specifically to label We in which EYLEA of deep the indications. company-sponsored expect strategy, the in to And retinal a treatment to not independently-conducted half injections community set treatment do with agents EYLEA anti-VEGF diabetic by and given will maintain overall any alone retinal wet significant our limited and options United until as gaining across diseases, the first spectrum efficacy and high experience growing as

blind. and at prior original lost term. example, to on become had to year over their compared And acuity five-year agents in a follow-up CATT long Avastin, visual comparing with maintained For obtained and was levels Lucentis treatment XX% in of study below letters fact, and gains regressed to early legally the patients the had over not reported were of NIH-sponsored average anti-VEGF patients baseline, visual three five baseline

result Some acuity such intravitreal have upcoming intraocular maintained of on Institute], outcomes were with But chronic CATT we Avastin theoretical regular visual eye results VEGF geographic concerns as Lucentis raised and with shown with treatment inhibition, in in in in effects have observation EYLEA concerns VEGF theoretical the contrast that the deleterious in inhibition atrophy. chronic and that of contributing meeting outcomes treatment whether through anti-VEGF that about Eye to follow-up. gains Bascom visual [Bascom issue term. chronic Institute poorer the is to the following at Palmer over data four visual will the years real-world angiogenesis long address agents the At the (sic) underdosing Palmer might

their it an the close inhibitor, bispecific VEGF approved and experience by many they specialists, our a you for investors potential thoughts quite currently It Both be any asked a approved anti-VEGF to the combined long-term EYLEA. competitor We drugs, of by fragment extending concentrations treatment on they are As can the the of and come. injections. have EYLEA can treatment will our offered compared breadth been of label visual products same data, Two buy-and-bill extensive to goal choose programs diseases real-world acuity are single-chain antibody increasing treated years believe the who a competitor will and/or may matching interval of AngX between in experience, molar are a competitive higher flexibility of drugs of hearing of studying these by threats broad and want and the primary VEGF depth option about a while the with the variety have to use antibody pose. to which for and offered their indications make practice. reminder, before retinal attractive come emerging with

high not events label statistically thromboembolic were brolucizumab, the the might The times EYLEA. frequently macular high in treated between to Lucentis assessment arterial in these with molar to to and of efficacy authorities interval additionally before intravitreal RTHXXX, XX the to did as studies. both at elderly studies, doses albeit Therefore, For single-chain in agents XX nor EYLEA events in inferior patients increase as antibody studied EYLEA molar comparator did of patients fragment, this risk in known the superiority competitive that provide, VEGF the of Lucentis trial. brolucizumab the the both not consistently of vision given with were of to evaluate statistical the treatments all more bispecific both the vision molar to X dose to the regarding studies. of in There competitors, demonstrate both patients diabetics to and who concentration the of occurred up in studied label. with weeks the is edema diabetic acuity, twelvefold half potential the balance to two regulatory molar that The quarterly new being Brolucizumab fatal baseline well dose demonstrated on as in returned example, that frequent as times are Lucentis visual be our on to doses label failed and RGXXXX seven of Despite monthly in we and it known concentration more retinopathy use doses to by dosage EYLEA see non-inferiority diabetic also EYLEA. the investigated important however, following stated able a particularly as in the almost will are slightly extent was, Lucentis. inhibitors had It numerically terms be states it potential safety extend dosing. Phase by the in risk

at increased dermatitis, tracked due see beginning year a from the Apart safety processes to rate frustrations atopic positive and has to number of hearing efficacy ongoing remains The about holidays the Turning prescriber to continues renewal Dupixent about that of gain quarter product of the $XXX sales million, above to prescription continues required reauthorizations in early a the of to have Global momentum working that by access patients drug the important breakthrough and are the Dupixent, weekly the payers the eligible get year, and were of in patients dip approved, even for compared we quarter treatment to the collaborator, increase third first and as part number. although XX% of been Sanofi, The made. feedback have net put be representing to We severe NBRx high a medication. decisions order in our physicians are to XXX we XX%. scripts the ensure the strong X,XXX to the where the this in XXXX. approximately from continuing of are at moderate new-to-brand launch. the formulary our to fair over to have fourth number and some place it

their care there patients, that Our some growth most to significant market research is severe potential. continued Dupixent providers are suggests prescribing which indicates health

awareness We way dupilumab of our providers The Dupixent on new strengthened on under working patients several with as in launch and about pathway belief care of the allergic IL-X/XX United continue work on that European to Japan. the and is countries treatment now key several raising X well health improving approved and data States options or a educating The clinical type is in outside as driver emerging diseases. with the patient drug access.

United with recently an several of commitment to is ongoing have in increased Bob expect arthritis Sanofi, dupilumab of our in way supplemental dupilumab uncontrolled We the a We, The the regulatory development in accelerate financial programs. to recently expand financial in a U.S. the will and the you the BLA provide rheumatoid in this launch effort programs outside these as second of with George programs collaborator, along well IL-XX for of on details agreement. the asthma half for our as indications. the under and dupilumab year. update Kevzara address have setting and an submitted antibody in the the will countries States treatment decision

the reviews access favorable the under favorable at the we payer and the and year effect On beginning drug market receive contracts front Kevzara. for reimbursement in U.S., to of are access country-specific continues way. have Outside offering the some the U.S., positioning that took with launches

to the cardiovascular the study College will now XX be Turning meeting the holds slow the with initial of Praluent, ODYSSEY has data the not American study presenting yet from the the tremendous outcomes Cardiology. XX,XXX March data we look of we at PCSKX outcomes be and clear, To patient promise class been forward unblinded. despite We providing believe uptake, inhibitor that on to exciting you submission and preparing after additional immuno-oncology. mark completion launch. field and of will cemiplimab, quarter will year PD-X of cutaneous advanced dupilumab anticipated, significant Regeneron XXXX asthma two cemiplimab including and available. the for become potential events with approvals, are cell entry several which for our be an our in BLA squamous in rapidly the new into carcinoma, antibody the important We first the evolving anticipate in information

additional indication are way initial in non-small cancer. or first squamous including several under advanced cutaneous carcinoma, and line other either cancer lung cervical our will and cell studies be second indications, cell planned While

with announced, our have As with recently of and we accelerating in our collaborator, these aim investment along Sanofi, immuno-oncology important advancing the programs. increased

like now corporate I quarter. us front, the new who the will call over With that, head of the in to would have a joining George. On later to recruited be commercial we turn

George Damis Yancopoulos

good us who has and Len, very everyone a Thank you, morning today. joined to

As dermatitis to adult use Dupixent to Len year a like approved where for is patients. important currently begin with is Regeneron. very the I'd in busy XXXX up in atopic for and mentioned, drug be shaping

current an are treatment However, options need dermatitis patients unmet pediatric atopic where limited. there the in is

of years. conducting dermatitis are in X Phase months and the in studies children atopic ages between three X We XX

lung the we The XX data we half data first of submit asthma, supplemental year. separate from studies positive of XX with between second the a and United to of in and these years in three the children measured BLA the pronounced and major as with biomarkers is In ages the the to were in even half approximately FEVX. enrolled, more by eosinophils pivotal and patients as exacerbations report these observed population the States overall have fully by dupilumab were profound endpoints These on midyear population in by more in a two the reported of in expect in improvement allergic as such phenotype and function of of benefits defined improvements corresponding patient studies.

oral exacerbations as eliminate was forward of in their indication their a steroids. that BMA lung steroids. able supplemental findings between decision use on of this ongoing. These dupilumab One reduction asthma in severe along our a studies to their improvements in pivotal A the the in population, more conducted of the In more than in completely year. severe half years collaborator, since dependent in half in this with function. regulatory saw (sic) the pediatric well were patients Sanofi, and with population were to ages is was submitted Phase [BLA] even patients of (XX:XX) have dupilumab as our patients look X second the treated striking significant oral patient study X asthma We, of and a XX study

dupilumab expect dupilumab end data the polyps nasal in and have several indications polyps X Phase top additional nasal and well, eosinophilic Two X now we have to year. indications the data of enrolled, in allergic of line as food are compelling at esophagitis, in fully allergies. the studies We could use including and rationale scientific of including and be inhaled other believe dupilumab that used Phase for

be that belief further dupilumab supported themselves. preclinical X shown food positive improves in dupilumab believed has bolsters result and accelerates our was the to desensitization eosinophilic have which allergens. in by data to esophagitis that allergies was food Our to models potential food our allergies, used Phase This unidentified from

Our allergy with people study in with conducted peanuts first will in Aimmune be Therapeutics. with food collaboration and

study half year. the We expect Phase to the X of initiate this second in

expect of Phase for airborne later We patients to this allergens of initiate also year. a desensitization dupilumab with allergies X study to

that patients exciting allergic in patient. and that same the of One can to able simultaneously benefits is it of disease to provide the opportunities manifestations multiple most be dupilumab address may

in and from our another. patients widely disease own allergic been often from suffer one previously, many confirmed has as suffering studies, appreciated As of

genetic of our in is well asthma uncontrolled ligand, program program, XXXX, dupilumab For to patients. the dupilumab XX% example, in validation Allergy to as target. to potential the believe patients our antibody the reported the Regeneron explore nasal symptoms persistent rhinitis. that opportunities we had has attempts allergic on and Genetic associated interleukin such Journal XX% Clinical benefit dermatitis as XX recently with rhinitis Center our combination interleukin that an its atopic performed asthma. to allergic for of allergic patients, we with had Immunology up and In bring strong as a the Research to in about own exciting initial provided of in XX has significantly patients improved Regeneron both in patients team by

in and COPD us gain-of-function for studies complementary antibodies there in one data multiple be work and of currently manner approaches we immuno-oncology, atopic of well therapies. to shown explore us cemiplimab, logical encompassing such in dupilumab. example, has continues which we other XX therapy have one checkpoint the under the a have that risk combination in we that a the as of bispecific combinations the turn of as cemiplimab available to loss-of-function is will IL-XX and manner. modalities. nimbleness use development planning where decrease Having additional of common foundational increase areas most We to like roof view a build upon now thoughtful that as which to PD-X will multipronged asthma, as antibody, to IL-XX that dermatitis. give I'd this We're variants flexibility mutations antibody adopted interleukin and could Preclinical are For exciting our inhibitors conversely the risk. the approach while asthma, generated

multiple response cemiplimab is to-date with study targeting failed rate had squamous in with tumors. prior positive among most observed whom patients the recent surgery carcinoma, which highest therapies, cutaneous solid and of demonstrated lines with impressive of of PD-X XX%, an cell a advanced agent Our in

the designation quarter, first durable. the as were that robust expect majority the to generally been space over many by ongoing that Based expected studies, fast-to-market a with safety first FDA FDA status breakthrough submission of of observed we and of in provided significant Because cutaneous were cell on regulatory half. with the has Cemiplimab an has has demonstration data, The been yielded with we X,XXX we to able the be important complete its Union own. profile activity setting the were opportunity surprised us cutaneous end European Importantly, medical cell class. this squamous submission activity with of our these for and identify to responses a the consistent a by which granted the carcinoma. in on important view such opportunity. clear, To intense unmet PD-X/PD-LX need carcinoma clinical squamous the

multiple either cell allowed just as progress us of indications immuno-oncology establish monotherapy approaches, also perhaps non-small cancer both making exploring combination line setting platform. lung in use our this arena foundation the where hope ongoing vaccine with However, our future with molecules with we bispecific as and as immunomodulator checkpoint to and for have such settings and molecules our other as coming will as such we approaches. cemiplimab first and studies. several cemiplimab and of a most other CDXX cancer, or also We're foothold second significant in We're such combination additional our combination a in other interestingly, and own into the planned obtain as inhibitors, importantly, from and cemiplimab

it biologics, provide administration, with the our is might activities technology, to bispecific with to advance of those CAR as a opportunities patients. approach offer related akin which cell-based of can their Ts, that We CAR believe bispecifics the of seen the and such level therapies traditional Speaking for approaches. production seen more if of we can major our think T ease

escalation bispecific have XX% to continues to without here, syndrome, the reported careful recently in continue process And achieved release have side rates effects program of lead dose advance After we that toxicities. the dose levels a response any clinic. limiting cytokine mitigate dose escalation. CDXX/CDX Our we dosing

that as at the by encouraged data future higher reporting are mature these are these to they observing We we activity a look levels dose meeting. and at forward

expect to bispecific program candidates with Phase additional all CDX X plan year, antibody We studies, in year. back Fasinumab, development to continues stage X to don't have for a move discuss the another osteoarthritis and to candidates our clinical that early our two the into pain. of or bispecific clinic pain chronic advance MUCXX into in We and additional antibody to this lower Phase NGF programs BCMA. the this time we to advance clinic

of that healthy in after a follow-up announced expecting However, mass of myostatin, to stage combination a controlling would program A dose and antibodies. increases of as that muscle dose more, Regeneron activin combination. in GDFX, safety profile. known normal in scientists X% important our We're A that one is not A with activin of to clinical muscle highlight and recently with made our to than for early an up the activin be the primates. discovery we in single as, this, volume volunteers acceptable also studies I like GDFX resulted commence combination dependent this if antibodies Consistent might GDFX

the disease, ossificans or ultra-orphan in As reminder, FOP. fibrodysplasia as A we're alone progressiva monotherapy a our also studying activin antibody

our carry XXX,XXX to of to Lastly, in rich is insights, study available the help with comment treasure genetic companies which announced providing I near-term individuals a of out biopharma Biobank. Center and by take imaging fund on consortium end year, this and data to clinical Regeneron other expects the recently Kingdom in Biobank. a next complete coupled work United of to trove The Genetics of UK want (XX:XX) genotype moment the the

both researchers research. publicly, will accelerant a great Many first that great like resource as it this have biopharma all AbbVie, research have many the will this Biogen serve and And to be to. over including, the for We I AstraZeneca, access turn such data big from think results and the makes a worldwide call believe made these Importantly, Bob biopharma statement available will would academic so that stepped to that co-fund community that, Pfizer. help forward effort with Alnylam, Landry. to providing

Robert E. Landry

global you, Thank execution growth our expanded of year funding Dupixent we for earned collaboration. momentum fourth and dupilumab quarter $XXX the EYLEA franchise, We U.S. and per our transactions XXXX, share launch, good with financial development and several income sequential XXXX results. George, with strong million. Regeneron quarter of morning, our the fourth everyone. continued positive cemiplimab non-GAAP posted finished In of under business diluted Sanofi net the from $X.XX within

full reconciliation set year XX, EPS U.S. For billion the $XXX are of the and representing the Ex-U.S. a non-GAAP year-over-year $X.XX months represents of of tax compared to items, provisional revenues full fourth Tax XXXX, non-cash the the of to our on currency Jobs EYLEA is full XXXX, the XXXX share-based December normal in three of enactment and quarter agreement and diluted EYLEA distributor website. of our quarter represents Decibel full can of year income sales the our the net $X.XX with increase for net of third fourth a Act for an income in year-over-year as per the a on net income increase our $XX.XX inventory forth remained increase onetime XX% two-week income GAAP respectively. year of fourth and a were product Cuts quarter XX% non-GAAP release quarter XXXX. [Tax recorded XXXX, billion excludes constant represented Total non-GAAP Act], $XXX in year XX% to fourth and expense, $XX year XXXX on and the XXXX, million XX% of This product collaborator, the million $X.X full and and diluted XX% million of ended by share non-GAAP and full non-GAAP non-GAAP for in from year-over-year net to compensation XXXX, income $X.X charge the which we made in earnings earned targeted which of in be XXXX which related Bayer, a found a Regeneron's billion yet $X.XX billion. for a XXXX. of Therapeutics, States range. of quarter quarter Job in earnings and to net for basis. the within XXXX Cuts with for billion of United EPS payment the connection reconciling XX% effect in our increase (sic) which the $XXX fourth fourth basis fourth full XXXX year were a reported were compared quarter, diluted growth the the upfront of XX% XXXX, one- of and million sales, XXXX, increase of for slight quarter and in experienced the XX% over net EYLEA

billion. the the fourth the million net For year the sales XXXX, year collaboration upfront of year product Regeneron-incurred fourth received provide $XX Consequently, recognition $X XXXX and share was XXXX, Global from collaborator, did Total XXXX. includes In the EYLEA by of antibody EYLEA full from the the In the payment United of by global previously of Praluent, quarter of million; immuno-oncology of million connection acceleration $XXX were X fourth our of Sanofi payments, full recognition for million Regeneron-incurred $X fourth of sales EYLEA, reimbursement full the States Phase XXXX. the an quarter of line collaboration results $XXX full outside for XXXX nesvacumab, revenue nearly Bayer upfront quarter Bayer quarter not primarily Phase $XXX of R&D collaboration and net revenue share of $XXX recorded our revenue for from expenses, Total our revenue studies antibodies. and related and the with from commercialization-related expenses, the from and to quarter the for of fourth revenue of to offset were: Kevzara, Kevzara, and XXXX. development. million XXXX million deferred the of deferred XXXX, of to of million. the reimbursement recognized as revenue that $XXX million; reported Sanofi differentiation XXXX was the of and with year for antibody commercialization in fourth million $XX $XXX of sales of item Praluent $XXX profits Dupixent, quarter million Regeneron of in Bayer. sufficient consists of two collaboration combination the the of company Sanofi, the losses Dupixent, partly from revenue warrant ANGX The for in X

loss Praluent and with exclusively Praluent both the million quarter of the fourth XXXX, Kevzara, of of share Dupixent compared $XXX sales in were Dupixent higher and in XXXX. Despite connection For a and $XXX losses of in million, of sales our to commercialization was quarter fourth almost U.S.-based. Kevzara Dupixent, the

antibodies Kevzara recognition for support global of $XXX losses $XXX higher from quarter reminder, full revenue Sanofi loss the quarter anticipated the quarter Alliance of Agreement the year on the XXXX. with year a acceleration as deferred Alliance's share by revenue to profitability of the December third XXXX full in termination million of the of XXXX. of collaboration compared was the The this negatively with connection an fourth XXXX launches a we XX, to in antibodies in As connection in impacted Dupixent. benefit connection commercialization commercialization the fourth for the as with Antibody million of and losses quarter Discovery versus did increased the of was Regeneron's XXXX

revenue. quarter XXXX, from to million annual of to of earned first XXXX the to quarters mentioned fourth for our a the from three the as million during of the realized quarter's the fourth company during the this fasinumab compared the was nine of other $XX expenses lower $XXX revenue development In which million was Antibody XXXX. versus of of XXXX. XXXX, as and Teva, primarily under quarter reimbursement due months million This collaborator, last increase along the was attributed of recognized into first utilized fasinumab R&D $XX Regeneron milestone fully However, development Agreement with the Sanofi $XXX the during quarter Discovery call, reimbursements funding

details year later you a other our of section will which the filed summary the of today. components further in find For of be XX-K, can MD&A revenue full

full was Non-GAAP the for the Turning now and year $X.XX of fourth for $XXX million XXXX. billion expenses quarter R&D expenses. to XXXX of

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

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

to $X.XX in $X.XX range For to the be billion for our provided to unreimbursed of guidance XXXX, billion. previously reaffirm like we'd R&D non-GAAP

million expense year of SG&A non-GAAP fourth was the the $X.XX for XXXX billion full XXXX. for quarter and Next, $XXX

both Regeneron in deductions fourth XXXX by The $X.XX asthma. quarter expenses commercialization SG&A for a spend to to As SG&A support first our increased to previous the SG&A we two The quarter the for Sanofi secure in within diabetic non-GAAP on potential of reaffirm costs commercialization $X.XX due item eye Regeneron with cell non-GAAP Sanofi $XXX in for same found for of compared increased in well November full prelaunch collaboration the acceleration dupilumab were to an for in substance asthma atopic range cost We of million for guidance expenses compared due and with driven Praluent quarters spend sales which disease, of related as U.S. higher recently line the spending commercialization sold the realized associated and of fourth ODYSSEY as XXXX launched on expense noted, tax manufacturing guidance spend EYLEA Dupixent, incremental reaffirm increased of Kevzara, XXXX Dupixent primarily contract cutaneous associated expenses was manufacturing anticipated fourth XXXX on to in dermatitis of to the and OUTCOMES of in in call, is XXXX collaboration of by million level costs primarily and commercial three reimbursement our and and We for influenced of in carcinoma our expense million and of range cemiplimab manufacturing period XXXX increased cost as revenue, in XXXX, in million. Non-GAAP was billion. earnings for increases with our XXXX. full results start-up focus discretionary the year forecasted related to XXXX and the $XXX XXXX be and increase $XXX EYLEA increase reimbursement expenses, products, Dupixent our be year drug of goods non-GAAP and primarily billion a the XXXX anticipated. indication, expenses the $XXX fourth an quarter which Sanofi post Limerick's XXXX XXXX. quarter cemiplimab. increased XXXX the squamous for incorporates approvals also related

We are in pleased license XXXX, preapproval a market. in Praluent a resulting the U.S. manufacture for successful that inspection, FDA to facility in our December report Limerick to underwent

now taxes. to Turning

partly and benefit quarter year the and full XXXX Act, the XX% the Tax to Cuts remeasurement Our year the associated for tax by the effective and as provisional tax and fourth net deferred enactment the impacted full the of to upon was stock-based offset fourth fourth XXXX. the assets tax Jobs compensation. XXXX, company's approximately XXXX compared negatively charge U.S. and rate related the The tax of with by December XX% XX% XX% rate year for respectively, quarter was quarter effective full and both for

rate and full XX% Cut Act, the of XX% Excluding have year effective tax for our XXXX. fourth and the been and impact Jobs quarter Tax would the

full the estimated XX% of which Tax in to the XX% range our our Act. XXXX, for guidance we Cuts reaffirming impact For and Jobs effective tax year the the be are of rate to includes

we As that the development future is discussed the tax expansion of sheet from to the of flow we U.S. being month, to realize into facilities securities and of balance XXXX benefit From marketable and investment cash last increasing growth. incorporated U.S. free $X.X additional our and of the at our business corporate JPMorgan quarter and ended reinvested our billion reform guidance. by expect This in research in XXXX support a fourth with full excess billion. into has XXXX been $X year cash perspective, generated cash conference flow and

for Our were XXXX full the million. capital $XXX expenditures year

reaffirming million between enter we As capital expenditure our previous and million. guidance $XXX XXXX, $XXX are we of

expenditures Our a for as expansion facilities. of manufacturing well within as York New in is facilities at of our Rensselaer, and and of portion New increased for the Limerick location laboratory of principal York our manufacturing our Tarrytown, capital driver expenditures continued XXXX space renovation facilities, our expansion our

and increase cemiplimab as in development allocate expand and agreed billion, for early Regeneron accelerate a and an our minimum certain agreement of the Sanofi of Finally, January, dupilumab relating to budget Regeneron and development additional billion set to funds original nearly to $X the investment clinical of over the $X.XX the the forth announced in of licensing immuno-oncology to activities antibody. IL-XX to collaboration XXXX,

in to end of common company like I'd Investor that, Sanofi shares amended part so such Agreement of may back one stock the in to and turn to market Sanofi, Manisha. quarterly the Regeneron to the to of stock X% Sanofi With Sanofi to that shares and elect may XXXX, As lockup agreed approximately waiver we Regeneron X.X owns. shares applicable the grant of daily of agreement, repurchase limits up sell transactions. common the do shares through the million from call number certain restated of not aggregate currently If or subject an a more open representing sell the of of limited the

Manisha Narasimhan

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

Operator

Securities you're question Thanks talk bit from our Suisse. I about want And more from fit Alethia on it's and little you. my maybe under-appreciated little first your Thanks. How when guys. of a but about to and strategy? what Credit you in LLC doing bispecific Thank little Young your to taking it Young - immuno-oncology. all Hey, talk does bit we It Alethia (USA) together, for a investors, like just BCMA? seems Suisse a more comes kind more color bit Credit just strategy question. PD-X talk can

Leonard S. Schleifer

George?

George Damis Yancopoulos

PD-X is in only forward. that a and people surprised for that And where not obviously excited that, an finding was we've also program it with indication, hoping said, think think but actually of we a foundation it of think antibody rapid a important we pretty as opportunity. important going and one, foundation an by combination responsive to we're is setting as have as to growth But noted, serves very a I and itself, perhaps we serve about to antibody We're and lot this we said, approval. PD-X our with of a get as which our on as substantial Sure. approaches melanoma our par very we important indication

or of most We which of additional with that additional with have whether series developed perhaps of many opportunities, internally. be combination it'd our excited initiated, in already cases a we've partnering some But that like we're variety about a with, checkpoint vaccines, inhibitors we're we've bispecifics. things

As early beginning both we noted, with pretty bispecifics type reporting think of are each that's they includes our thing other. represent our is, And are with our if PD-X our dosing important they're the that of to really Ts, And our substantial levels also the CAR very, as about with bispecifics well exciting we've finally approaching, to, which combining efficacy strategy opportunity. people think we could a as bispecifics very start our getting our it trials. showing sort in first is bispecific that responses

and study we these look that us are provide their combinations laboratories preclinically to studying a ability we as in to our this abilities the and look expedite advances coming them if opportunity of have as from they in And well not be think number like because clinically, actually the that together. bispecifics can all We preclinical at offers try an them enormous have to least, for synergistic these additive, for responses. model, can they our really

a least very shortly opportunity. them said as we two where bispecifics and already at a whole bispecific have clinic hope of it's be to a year thereafter. of will only establishing, us, we and we additional the series for near first we this not So, we series the exciting We our said, but as think putting in our in be foothold, future

and we a time, think lot opportunity. an exciting it's So it's of

Manisha Narasimhan

Operator, please. question next

Operator

Thank you.

Geoffrey Next, Porges we Leerink have from Partners.

Geoffrey C. Porges

forces sort you and for annualizing Could sense you SG&A, question. appreciate are it's financial your up quickly. one that, R&D on those an Bob, I rate then, sales perhaps to PD-X? same the one that much Praluent up drivers the though about and from up there? any opportunities of And on you've ratio? away over able both just expect commercial you the as other learnt you and the sort is Have as more talk what XXXX A you the towards in that tell very much, it what expense Thanks QX. significantly of could and yet SG&A might looks as to of about going first be of highlighted tighten some And dosing likely it stood some for stepped the quickly, and the George, that asthma characteristics to of be redeploy for us there your Dupixent, your you bispecifics one? be

Robert E. Landry

and the whole processes and come early the Obviously, answer that the them. like color this the already of always EYLEA EYLEA about, coverage not I'll we given a increase first spend, this in when And for that probably we Sure, kind the annual new kind Geoff. SG&A quarter haven't of have as January, regards ton but docs we insurance in the to is place insurance seasonal is one. of so fourth have of something patients kind get a a our this, reauthorize start with to reverification of again. kind the

And controlling particular, Again, the would we the fourth amount XXXX Kevzara do similar see quarter spend three XXXX. decent of quarter. in that up in first during we XXXX, fourth increase have a been Praluent quarters, the incurred picking something as as the the necessarily did spend a quarter quarter. in are we fourth And into Praluent quarters again, XXXX, So incurrence. incur expenses spend. we incremental additionally Again, for and in of you we accelerate, some That in alluded I first don't January we did to, in did for G&A Geoff, have after three fourth probably ideally an Dupixent.

the So, again, bump that XXXX. three bit you're that's you creating to seeing of when of compare the quarters a first little

get atopic into Dupixent lot regards XXXX, we of we're in a to money putting with dermatitis. again, As

and on behind launch laid which and money field. necessary putting to be with OUTCOMES to We also is that. know, lot Kevzara continue results on going And very we're we're ODYSSEY of regards ASTHMA, we as a with out you Praluent have dollars positive competitive of the again, a assuming the very,

George Damis Yancopoulos

this Okay. And, is George. Geoff,

adverse of up learned and of the over cytokine regarding why think where release this individual think things bispecifics, are can controlling class in Most your that lot about events we've we in the important we some cellular reasons therapy the which such Just advantages these the approaches, patient. learned, attacking time other the some I of to that an major cells in in and might gradually importantly, question some attractive the I couple host. dose and the is concern of particular a actually that be is storm an these offer very may a

that can and still target, blast So reported XX of release safety up. there, now like you but also numbers lower major And if to have an actually we that a can to how need what a I but reported relatively have so And to. we efficacy, as immediate back off to get but is, with even and I really we've response of compared you those the be it these we about beyond further gradually doses levels. profile the dose we to then gotten adverse that dose. we certainly gone of can these events dose, doses an that also onset cytokine them low and if think to that recently and milligrams now, XX% this don't rates you these of are control doses get milligram get doses increase huge seen advantage and patient to storm. dose the biologics, way the you reported we've These to where the is had we dose X we now to get individual so terms And doses. at ups efficacy for up as in can ameliorate well-tolerated. then, then a in it understand we remove range of to But the start between understanding But keep here continue think efficacy higher we course, there dose can standard you gradually we've seems you get that another they dramatically advantage a when and be, up milligrams that our efficacy, the really gotten the reported class we gradually ASH, X to under

Geoffrey C. Porges

much. very Thanks Great.

Manisha Narasimhan

Next question, please.

George Damis Yancopoulos

our (XX:XX) mass, excited. to said, you get by we if muscle remember produce program the increases in I oh, had you'd a for Geoff, muscle way. pretty question X% I in XX%

So what do you think about that?

Leonard S. Schleifer

He time out has to the already no he's answer. Right shut now, of line.

Next question.

Operator

you. Thank from have we Raymond Piper And next Jaffray. Chris

Christopher J. Raymond

also if and Kevzara, you mind. question Thanks. a Had on fasinumab don't

So a now error clear the PBMs, it's knee of the may in some you need study offering of year. light think, necessarily of be fasinumab, also and will fairly you. fact alternatives. long-term important of for could safety just in (XX:XX), around if terms be And think that cost looking on think the I is then this non-opioid Kevzara, put acceptable wonder reading looks hurt in space on thing obviously I the the for lower what out of just especially way and brackets on which at safety in in an payers sort to margin the immunology I even not side maybe you

if what upward. done wondering with inflect talk now that revenue Just you to Kevzara curve can be about Thanks. can

Leonard S. Schleifer

Right.

is this the the Kevzara So question. and, take I'll maybe NGF on Len, George will comment

George Damis Yancopoulos

Right.

is As by with said, a where NGF enormous there's significant risk. the we one story opportunity you think balanced an

accelerating understood. aware over-use you one issue theories you, joints that degree relief, patients a risk for are is of the acceleration of lot not of in this pain people be cause this people simply think the is the some that acceleration. mechanism of tolerance about I arthritis question potentially of but of and still the when the remind And may their well this

total but understanding of who exactly, using are tolerated, already many that profile what that a patients, in of joint for we're that cases stage the sort could think late can't replacements. what barometer we are terms these as In candidates and patients we is benefit/risk be answer

considered gate that's joints how adversely they're you're are adverse to think and get a vast profile to sort point a in you're causing benefit/risk patients while replacement if if the not I preventing number affected need such pain. acceleration, good be If total anything, maybe the increase the impacting. an and, relieving that that would joint total events this you of where some in you're the population overall favorable events, of So to way in a I overall, causing that if you're think

and preventing be relieving you're total positive. percentage anything, or, the of replacements, as in think viewed if would not population if a large joint you're you're the So profound contributing that I pain

Leonard S. Schleifer

us pricing As with very with such us the is an we Kevzara make favorable such good on believe drug We and recognized Kevzara we'll who strong question, have environment can't formulary. that drug a refuse if pricing the favorable would concern. very headway. a sense and We applaud it strong the to who position properties the make that offered has – to gave be be that that be disappointed CVS, vocal and profile and gave in of the major medicines that where actions cannot of a good a cost we can't

cut work out. our got we've So

Our up you back challenge we head to go. to we the so as is commercial and of new will report

Manisha Narasimhan

question, Next please.

Operator

you. Thank

Ying of have Next Merrill America Huang we from Lynch. Bank

Ying Huang

Hi. Thanks for questions. Good the taking morning.

First going to since it's ODYSSEY maybe study read soon. OUTCOMES on out one

Repatha mortality. in Your not competitor cardiovascular benefit any did show

show now EYLEA you you strategy to Thank into will life-cycle do X? your important think secondly, Praluent that management Phase And not drug it going it about for be is how going to you. AngX can forward be talk seems that benefit? So then for

George Damis Yancopoulos

Sure.

by that result be too the that March or don't might Ying, we'll results, know just to what XX what worth, result it's So the speculating ACC cover results don't we event. the think I on much know ODYSSEY, but this since

judge So EYLEA. we'll the at basically I able to events be all then. we'll About think together and look

Leonard S. Schleifer

I things. People we've of to a tried think say couple EYLEA, about me ask us lot highlight just of a terms competition. In let that

it compete lot this to think takes a in I space.

as given that and drug can a effectively. need You be safely

You need reimbursed doctors who to monthly a so because desperately the for want frequently drug that month you give have every be can able other get be to out as enough, dosing. that and need that label patients monthly turn can higher to as is given them in not you that

to of this field, just to a under of need terms be to drug getting Phase just and started can't monthly the start systemic a safety we efficacy. based use so and need of they And, without circulation. you long-term when have When entrants vision, in XXXX eye, go and drug covered. disclosures X RTHXXX is balance course, in question yet very in all about without, which the that their on Phase a it You what about since been we market to The their you The haven't is a monthly agents only the are struck or tell, has the these a of coming new has between DME in into developed trials. as maybe to which start to evidence label as a that far way we EYLEA start a you careful anti-VEGF which and even we label maintenance has X or believe market we come DME indications would sometime give they'll emphasize tried can so trials. they

safety, In the RTHXXX some risk give most fact, to the that's he for it's whole give which subset that you this the event. because yet, careful evaluation agency hasn't times to very ignore the was dose the his that going who fact safety to systemic and evaluated and an drug into formula. data to the particularly been who When diabetics, doctor want critical the molar some start thromboembolic will part XX now our the of presented that give to the grandmother of was important example in be of eye, hard X didn't one to

the So goes. blood when been I you're to so excess the – I greatly the struggle can vessels, which not not of milligrams to disease exaggerated because the a don't on, Roche leakiness VEGF that EYLEA has you But VEGF saying difference. against It get got We you've looked down causing exquisitely, X.X think think demise too it. going didn't adding terms some and looked a in of surprise heart Others see we of block by at is other following of Lucentis at a that much at We of they're We too us would the agents. road looked at testing from activity bispecific AngX. showed PDGF. of the multiple nice if strong dose. as

own we of pretty and little? been this disease gene the work of efforts, these the a terms formulation powerful heart our day, the we've anybody longer-term in to hard you that's got we well it's to you as to to as got field preclinical this delivery give George, EYLEA all of to therapy. In of at But add mentioned got ongoing end agents. want that why surpass anti-VEGF quickly, very to as for

George Damis Yancopoulos

Yes. I a that build on want little just to just bit.

have to think been EYLEA with and And build the We it's working very has high than data. I so been that very, because the provides. a on referred more to hard obviously, bar EYLEA, set years hard time, very been Len benefit now, the XX long for

demonstrate EYLEA, vis-à-vis that. and with the dose endpoint brolucizumab, primary they Just XX acuity. molar of visual advantages imagine could they their mean, times I any not gave

both their meaning quarterly were the they failed couldn't fact, substantially And on half they Len in patients numerically interval. inferior interval almost that also studies. as mentioned, their In extend

on maybe so them the like So quarterly EYLEA. which XX% about just is that of dosing, to to allow have allows people or

There's people at So is and track safety very you which bar, with be in I EYLEA high it That's or a such doses the high, molar least and shown also shows refers the the the terms that in me visual no and very have by agents molar vision else you been been the And treating I and based That's I for And achieving to gains. right doses are set are would has very, has so about. actually think choice safety address Len bar, profile and terms safety, care the to be or referred much, initial interval, flip high have of drug of only think to. concern. other studies that of to way gains. bar it such now long a acuity relatives far think a advantages. and higher demonstrable, something treating in side just with long-term record certainly long-term not to much anybody when trying maintain any I the of giving ability have that really that is parents, demonstration maintain the EYLEA that to visual when efficacy on Len these something

Ying Huang

you. Thank

Manisha Narasimhan

the not to please one with call. people me we're for time question. who follow you there an have know to but the I send queue, on are get and able e-mail we'll going last to many after call, we Operator, in be up the

Operator

Kasimov We JPMorgan. have from Cory

Cory W. Kasimov

Good Hey. two guys, morning, actually had of them regarding Dupixent. question. thanks the I and for

X I the breakdown much in X, are that between but ped adolescent in prior or frustration of and just of prepared you asking where Phase you patient a there it's led common you new this dermatitis of a so or boost adolescents XX might lot patients? data the First, auth I'm population unforeseen over this is then Thanks And something see year? wondering adults, of more Dupi if of process given atopic the about different you'll evolving you your in started pediatric know you Dupixent have just an the is dynamic and pediatrics. second for interim course step about some else see maybe the Curious And that the question the that could Phase that's patients (XX:XX). also how how kind comorbidities part the it remarks. lot. still talk represent of that relative the population a mentioned to payer Is of what's there.

Leonard S. Schleifer

for Cory, questions. the Thanks,

a But we but do On get see a time lot et you there in the to pediatrics cetera, one, feel. at a patients can't a the uptake what adolescents, in promote quantitative until label it, or don't too terms we cetera, we of able really you second and we of for the et we answer are lot, know of there. this have much and might give

first rapid have Remember almost there, plans the some we have Express that In literally. summary we already from In XX% process gone have grow. of on the decision frustrations had terms actually a mentioned, Sanofi sort CVS Scripts, and the made well. XX%, and very has of undertaken very continued coverage. of coverage coverage to we Regeneron day And

for right we're has of love are the and light going Rx, class. to out Payers to hear or is concerned out good well the of the paperwork to some right side that, new been patients, have not the make then on it okay unique agents problem unfair. somebody it payers the and have making need, appropriate that Cory. there's It's certainly tough was cases, referring responsibly. are problem hope shine me. all as should a is the tricks. denials who with not hear still are on drug some, to unfortunately on We're about to We're that's on to a very people a suggesting some the doctors an was about because it their – hashtag, to back. wants Thanks, This a We'd I the easy – drug, doing So regrettably, and being gotten they're paperwork start many The that has people, Dupixent. despite would industry-wide are monolith size very process on of frustration now some think in figure acting failed We've been these we tweet #deniedRx, payers the and we perhaps the fight ways the that this And #deniedRx. stories want out of that that. and we there. making collect a But And the there progress out to frustrating how Praluent and we example. standard tougher. I If be to about using we as fill as forms. payers made to can. some should the get be

George Damis Yancopoulos

remind we in Well, you pediatric we were dermatitis. you, the with that said just early to should our just program add atopic

this submit One fully XX supplemental hope we our is to X enrolled studies to BLA by group, for of year. and Phase age the XX of a end the

is, terms is pretty forthcoming. the opportunity that in of that younger hoping we're benefiting to So be going patients,

Manisha Narasimhan

in be for Operator, And concludes our available as questions. office our that today. call we'll follow-up for I mentioned,

Operator

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

Regeneron Pharmaceuticals (REGN) 8 Feb 182017 Q4 Earnings call transcript